1–13–10 Wednesday Vol. 75 No. 8 Jan. 13, 2010

Pages 1697–2052

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Contents Federal Register Vol. 75, No. 8

Wednesday, January 13, 2010

Agricultural Marketing Service Commerce Department PROPOSED RULES See Industry and Security Bureau Tart Cherries Grown in the States of Michigan, New York, See International Trade Administration Pennsylvania, Oregon, Utah, Washington, and See National Oceanic and Atmospheric Administration Wisconsin, 1724–1731 See National Telecommunications and Information Administration Agriculture Department See Agricultural Marketing Service Comptroller of the Currency See Animal and Plant Health Inspection Service NOTICES See Forest Service Agency Information Collection Activities; Proposals, Submissions, and Approvals, 1840–1841 Animal and Plant Health Inspection Service RULES Defense Department Change in Disease Status of the Republic of Korea With NOTICES Regard to Foot-and-Mouth Disease and Rinderpest, Meetings: 1697 Board of Regents of the Uniformed Services University of NOTICES the Health Sciences, 1756 Petition for Determination on Nonregulated Status for National Defense University Board of Visitors (BOV), Genetically Engineered, Insect-Resistant Corn: 1756 Syngenta Biotechnology, Inc., 1749–1751 Drug Enforcement Administration Centers for Disease Control and Prevention NOTICES Importer of Controlled Substances; Application, 1812–1813 NOTICES Manufacturer of Controlled Substances; Registration, 1813– Agency Information Collection Activities; Proposals, 1814 Submissions, and Approvals, 1790 Meetings: Education Department Study Team for the Los Alamos Historical Document NOTICES Retrieval and Assessment Project, 1793–1794 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 1756–1757 Centers for Medicare & Medicaid Services Applications for New Awards (FY 2010): PROPOSED RULES Small Business Innovation Research Program (Phase I), Medicare and Medicaid Programs: 1757–1761 Electronic Health Record Incentive Program, 1844–2011 Energy Department Civil Rights Commission See Federal Energy Regulatory Commission NOTICES Hearing on the Department of Justice’s Actions: Environmental Protection Agency New Black Panther Party Litigation and its Enforcement RULES of Section 11(b) of the Voting Rights Act, 1751 Approval and Promulgation of Air Quality Implementation Plans: Coast Guard Mississippi; Update to Materials Incorporated by RULES Reference, 1712–1715 Drawbridge Operation Regulations: Revisions to the California State Implementation Plan: Curtis Creek, Baltimore, MD, 1705–1706 San Joaquin Valley Unified Air Pollution Control District, Intracoastal Waterway (ICW), Inside Thorofare, Ventnor 1715–1723 City, NJ, 1705 NOTICES Upper Mississippi River, Dubuque, IA, 1706 Approach to Using Toxicogenomic Data in U.S. EPA Federal Civil Penalties Inflation Adjustment Act – 2009 Human Health Risk Assessments: Implementation, 1704–1705 Dibutyl Phthalate Case Study, 1770 Regulated Navigation Areas: Proposed Consent Decree, Clean Air Act Citizen Suit, 1770– U.S. Navy Submarines, Hood Canal, WA, 1706–1709 1772 Security Zones: Receipt of Applications: Escorted U.S. Navy Submarines in Sector Seattle Captain Pesticide Experimental Use Permits, 1772–1773 of the Port Zone, 1709–1712 Receipt of Pesticide Petition: PROPOSED RULES Residues of Polymeric Polyhydroxy Acid in or on All Drawbridge Operation Regulations: Food Commodities, 1773–1775 New Haven Harbor, Quinnipiac and Mill Rivers, CT, Receipt of Requests to Voluntarily Cancel Certain Pesticide 1738–1741 Registrations, 1775–1780 NOTICES Terminate Long Range Aids to Navigation (Loran–C) Signal; Executive Office of the President Correction, 1799–1800 See Presidential Documents

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Farm Credit System Insurance Corporation NOTICES NOTICES Environmental Impact Statements; Availability, etc.: Meetings: Lower Florida Keys Refuges, Monroe County, FL, 1803– Farm Credit System Insurance Corporation Board, 1780 1806 Receipt of Endangered and Threatened Species Permit Federal Aviation Administration Applications, 1810–1811 RULES Airworthiness Directives: Food and Drug Administration Dassault–Aviation Model Falcon 7X Airplanes, 1697– NOTICES 1699 Draft Guidance for Institutional Review Boards, Clinical PROPOSED RULES Investigators, and Sponsors: Airworthiness Directives: IRB Continuing Review After Clinical Investigation Sicma Aero Seat 9140 Series Passenger Seat, etc., 1731– Approval; Availability, 1790–1791 1734 NOTICES Forest Service Membership Availability in the National Parks Overflights NOTICES Advisory Group Aviation, 1834–1835 Environmental Impact Statements; Availability, etc.: Surplus Property Release at Moore County Airport, Helena National Forest, MT, Stonewall Vegetation Pinehurst/Southern Pines, North Carolina: Project, 1748 Request for Comments, 1839 Meetings: Eastern Washington Cascades Provincial Advisory Federal Communications Commission Committee and the Yakima Provincial Advisory NOTICES Committee, 1749 Agency Information Collection Activities; Proposals, Federal Lands Recreation Enhancement Act, (Title VIII, Submissions, and Approvals, 1781–1784 Pub. L. 108–447), 1749

Federal Deposit Insurance Corporation General Services Administration NOTICES NOTICES Meetings: Agency Information Collection Activities; Proposals, FDIC Advisory Committee on Community Banking, 1784 Submissions, and Approvals, 1788–1789

Federal Election Commission Health and Human Services Department See Centers for Disease Control and Prevention NOTICES Meetings; Sunshine Act, 1784 See Centers for Medicare & Medicaid Services See Food and Drug Administration Federal Energy Regulatory Commission See Health Resources and Services Administration NOTICES See National Institutes of Health RULES Combined Notice of Filings, 1761–1770 Health Information Technology: Federal Motor Carrier Safety Administration Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health NOTICES Record Technology, 2014–2047 Qualification of Drivers; Exemption Applications: Vision, 1835–1839 Health Resources and Services Administration NOTICES Federal Reserve System Maternal and Child Health Bureau, 1792 NOTICES Formations of, Acquisitions by, and Mergers of Bank Homeland Security Department Holding Companies, 1784–1785 See Coast Guard See U.S. Customs and Border Protection Federal Trade Commission PROPOSED RULES Industry and Security Bureau Children’s Online Privacy Protection Rule–Safe Harbor RULES Proposed Self-Regulatory Guidelines: Addition of Certain Persons on the Entity List: i–SAFE, Inc. Application for Safe Harbor, 1734–1735 Addition of Persons Acting Contrary to National Security NOTICES or Foreign Policy Interests of the United States and Analysis of the Agreement Containing Consent Orders to Entry Modified for Clarification, 1699–1704 Aid Public Comment: Agrium Inc. and CF Industries Holding, Inc., 1785–1788 Interior Department See Fish and Wildlife Service Fish and Wildlife Service See Land Management Bureau PROPOSED RULES See National Park Service Endangered and Threatened Wildlife and Plants: Determination That Designation of Critical Habitat is Internal Revenue Service Prudent for the Jaguar, 1741–1744 RULES Partial 90-Day Finding on a Petition to List 475 Species Modification to Consolidated Return Regulation: in the Southwestern United States as Threatened or Permitting an Election to Treat a Liquidation of a Target, Endangered With Critical Habitat; Correction, 1744– Followed by a Recontribution to a New Target, as a 1745 Cross-Chain Reorganization, 1704

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PROPOSED RULES Prospective Grants of Exclusive Licenses: Section 3504 Agent Employment Tax Liability, 1735–1738 Development of V–ATPase Inhibitor Compounds for Treatment of Human Cancers, etc., 1798–1799 International Trade Administration NOTICES National Oceanic and Atmospheric Administration Extension of Time Limits for Preliminary Results of RULES Antidumping Duty Administrative Review: Fisheries of the Exclusive Economic Zone Off Alaska: Light-Walled Rectangular Pipe and Tube from Turkey, Chiniak Gully Research Area for Vessels Using Trawl 1751–1752 Gear, 1723 Postponement of Final Determination: PROPOSED RULES Prestressed Concrete Steel Wire Strand from the People’s Fisheries Off West Coast States: Republic of China, 1755 Coastal Pelagic Species Fisheries; Annual Specifications, 1745–1747 Justice Department NOTICES See Drug Enforcement Administration Meetings: See Justice Programs Office Fisheries of the Atlantic; Southeast Data, Assessment, See National Institute of Corrections and Review (SEDAR); Atlantic croaker and Atlantic menhaden, 1753–1754 Justice Programs Office Gulf of Mexico Fishery Management Council, 1754–1755 NOTICES New England Fishery Management Council, 1752–1753 Agency Information Collection Activities; Proposals, North Pacific Fishery Management Council, 1752 Submissions, and Approvals, 1811–1812 National Park Service Land Management Bureau NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 1800–1801 Submissions, and Approvals, 1800 Environmental Impact Statements; Availability, etc.: Alaska Native Claims Selection, 1801 General Management Plan, Gila Cliff Dwellings National Environmental Impact Statements; Availability, etc.: Monument, NM, 1802–1803 Proposed First Solar Desert Sunlight Solar Farm Project, New River Gorge National River, WV, 1806–1807 Riverside County, California, 1801–1802 Meetings: Restoration Design Energy Project and Possible Land Use Big Cypress National Preserve Off-Road Vehicle (ORV) Plan Amendment, 1807–1809 Advisory Committee, 1809 National Register of Historic Places: Maritime Administration Notification of Pending Nominations and Related NOTICES Actions, 1809–1810 Assistance to Small Shipyards Grant Program, 1832–1834 National Science Foundation National Institute of Corrections NOTICES NOTICES Agency Information Collection Activities; Proposals, Solicitation for a Cooperative Agreement – Curriculum Submissions, and Approvals, 1816–1819 Development: Training for Correctional Industries Directors, 1814–1816 National Telecommunications and Information Administration National Institutes of Health NOTICES NOTICES Agency Information Collection Activities; Proposals, Public Telecommunications Facilities Program: Submissions, and Approvals, 1789 Availability of Funds, 1755–1756 Meetings: Center for Scientific Review Special Emphasis Panel; Nuclear Regulatory Commission Genetic and Genomic Analyses of Xenopus, 1796– NOTICES 1797 Application for License: Center for Scientific Review Special Emphasis Panel; GE–Hitachi Global Laser Enrichment LLC (GLE Hematopoietic Cellular Mechanisms, 1795–1796 Commercial Facility), 1819–1830 Center for Scientific Review Special Emphasis Panel; Final Regulatory Guide; Issuance, Availability, 1830 Member Conflict, Tumor Immunology and Meetings: Immunotherapy, 1792–1793 Advisory Committee on Reactor Safeguards (Planning and Center for Scientific Review Special Emphasis Panel; Procedures Subcommittee), 1830–1831 NHLBI Systems Biology, 1793 Advisory Committee on Reactor Safeguards National Center for Complementary and Alternative (Subcommittee on AP 1000), 1831 Medicine Special Emphasis Panel, etc., 1796 Request for Resumes: National Institute of Arthritis and Musculoskeletal and Advisory Committee on Reactor Safeguards, 1831–1832 Skin Diseases Special Emphasis Panel, etc., 1792 National Institute of Nursing Research, 1794 Presidential Documents National Institute of Nursing Research Initial Review PROCLAMATIONS Group, 1794 Special Observances: National Institute of Nursing Research Special Emphasis National Influenza Vaccination Week (Proc. 8472), 2049– Panel, etc., 1794–1795 2052

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Securities and Exchange Commission Separate Parts In This Issue NOTICES Meetings; Sunshine Act, 1832 Part II Health and Human Services Department, Centers for Transportation Department Medicare & Medicaid Services, 1844–2011 See Federal Aviation Administration Part III See Federal Motor Carrier Safety Administration See Maritime Administration Health and Human Services Department, 2014–2047 Part IV Treasury Department Presidential Documents, 2049–2052 See Comptroller of the Currency See Internal Revenue Service NOTICES Reader Aids Meetings: Consult the Reader Aids section at the end of this page for Debt Management Advisory Committee, 1839–1840 phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. U.S. Customs and Border Protection To subscribe to the Federal Register Table of Contents NOTICES LISTSERV electronic mailing list, go to http:// Agency Information Collection Activities; Proposals, listserv.access.gpo.gov and select Online mailing list Submissions, and Approvals, 1799 archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR Proclamations: 8472...... 2051 7 CFR Proposed Rules: 930...... 1724 9 CFR 94...... 1697 14 CFR 39...... 1697 Proposed Rules: 39...... 1731 15 CFR 744...... 1699 16 CFR Proposed Rules: 312...... 1734 26 CFR 1...... 1704 Proposed Rules: 31...... 1735 33 CFR 27...... 1704 117 (3 documents) ...... 1705, 1706 165 (2 documents) ...... 1706, 1709 Proposed Rules: 117...... 1738 40 CFR 52 (3 documents) ...1712, 1715, 1716 42 CFR Proposed Rules: 412...... 1844 413...... 1844 422...... 1844 495...... 1844 45 CFR 170...... 2014 50 CFR 679...... 1723 Proposed Rules: 17 (2 documents) ....1741, 1744 660...... 1745

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Rules and Regulations Federal Register Vol. 75, No. 8

Wednesday, January 13, 2010

This section of the FEDERAL REGISTER SUPPLEMENTARY INFORMATION: DEPARTMENT OF TRANSPORTATION contains regulatory documents having general applicability and legal effect, most of which Background Federal Aviation Administration are keyed to and codified in the Code of In a final rule1 published in the Federal Regulations, which is published under 14 CFR Part 39 50 titles pursuant to 44 U.S.C. 1510. Federal Register on December 28, 2009 (74 FR 68478–68480, Docket No. [Docket No. FAA–2009–1252; Directorate The Code of Federal Regulations is sold by APHIS–2008–0147), we amended the Identifier 2009–NM–248–AD; Amendment the Superintendent of Documents. Prices of regulations in 9 CFR part 94 concerning 39–16173; AD 2010–02–02] new books are listed in the first FEDERAL REGISTER issue of each week. the importation of animals and animal RIN 2120–AA64 products by adding the Republic of Korea (South Korea) to the list in § 94.1 Airworthiness Directives; Dassault- DEPARTMENT OF AGRICULTURE of regions declared free of FMD and Aviation Model Falcon 7X Airplanes rinderpest. We also added the Republic AGENCY: Federal Aviation Animal and Plant Health Inspection of Korea to the list in § 94.11 of regions Administration (FAA), Department of Service that are declared to be free of these Transportation (DOT). diseases, but that are subject to certain ACTION: Final rule; request for 9 CFR Part 94 restrictions because of their proximity to comments. [Docket No. APHIS–2008–0147] or trading relationships with rinderpest- or FMD-affected regions. SUMMARY: We are adopting a new Change in Disease Status of the airworthiness directive (AD) for the The final rule was scheduled to Republic of Korea With Regard to products listed above. This AD results Foot-and-Mouth Disease and become effective on January 12, 2010. from mandatory continuing Rinderpest However, on January 6, 2010, the airworthiness information (MCAI) Republic of Korea confirmed through originated by an aviation authority of AGENCY: Animal and Plant Health laboratory diagnosis that an FMD another country to identify and correct Inspection Service, USDA. outbreak occurred on a dairy farm in an unsafe condition on an aviation ACTION: Final rule; delay of effective Kyonggi Province. As a consequence, product. The MCAI describes the unsafe date. we no longer consider the Republic of condition as: Korea to be free of FMD. Therefore, we SUMMARY: On December 28, 2009, we Several occurrences of untimely radio- published a final rule in the Federal are delaying the effective date of the altimeter lock-up have been reported, where Register to add the Republic of Korea to final rule indefinitely. This delay will the failed radio-altimeter indicated a negative the list of regions that are considered allow the Animal and Plant Health distance to the ground despite the aircraft free of rinderpest and foot-and-mouth Inspection Service to consider the issues was flying at medium or high altitude. disease (FMD) and the list of regions raised by this development and decide A locked radio-altimeter #1 leads to what subsequent actions to take. untimely inhibition of warnings that could be that are subject to certain import displayed along with certain abnormal restrictions on meat and meat products ■ Accordingly, the final rule amending conditions while the avionic system switches because of their proximity to or trading 9 CFR part 94 published at 74 FR into landing mode during altitude cruise. relationships with rinderpest- or FMD- 68478–68480 on December 28, 2009, is * * * * * affected countries. The final rule was delayed indefinitely. [Untimely radio-altimeter lock-up] may scheduled to become effective on cause the crew to be unaware of possible January 12, 2010. However, due to an Authority: 7 U.S.C. 450, 7701–7772, 7781– system failures that could require urgent outbreak of FMD reported by the 7786, and 8301–8317; 21 U.S.C. 136 and crew’s actions. Republic of Korea on January 6, 2010, 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and * * * * * we are delaying indefinitely the 371.4. This AD requires actions that are effective date of the final rule. This Done in Washington, DC, this 8th day intended to address the unsafe delay will allow the Animal and Plant of January 2010. condition described in the MCAI. Health Inspection Service to consider DATES: This AD becomes effective the issues raised by this development Kevin Shea January 28, 2010. and decide what subsequent actions to Acting Administrator, Animal and Plant We must receive comments on this take. Health Inspection Service. AD by March 1, 2010. DATES: The effective date for the final [FR Doc. 2010–478 Filed 1–8–10: 4:15 pm] ADDRESSES: You may send comments by rule amending 9 CFR part 94 published BILLING CODE 3410–34–S any of the following methods: at 74 FR 68478–68480 on December 28, • Federal eRulemaking Portal: Go to 2009, is delayed indefinitely. http://www.regulations.gov. Follow the FOR FURTHER INFORMATION CONTACT: Dr. instructions for submitting comments. Julia Punderson, Senior Staff • Fax: (202) 493–2251. Veterinarian, Regionalization Evaluation • Mail: U.S. Department of Services, National Center for Import and 1 To view the final rule and related documents, Transportation, Docket Operations, M– Export, VS, APHIS, 4700 River Road go to (http://www.regulations.gov/fdmspublic/ 30, West Building Ground Floor, Room Unit 38, Riverdale, MD 20737–1231; component/main?main=DocketDetail&d=APHIS– W12–140, 1200 New Jersey Avenue, SE., (301) 734–4356. 2008–0147). Washington, DC 20590.

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• Hand Delivery: U.S. Department of You may obtain further information Include ‘‘Docket No. FAA–2009–1252; Transportation, Docket Operations, M– by examining the MCAI in the AD Directorate Identifier 2009–NM–248– 30, West Building Ground Floor, Room docket. AD’’ at the beginning of your comments. W12–40, 1200 New Jersey Avenue, SE., We specifically invite comments on the FAA’s Determination and Requirements Washington, DC, between 9 a.m. and overall regulatory, economic, of This AD 5 p.m., Monday through Friday, except environmental, and energy aspects of Federal holidays. This product has been approved by this AD. We will consider all comments the aviation authority of another received by the closing date and may Examining the AD Docket country, and is approved for operation amend this AD because of those You may examine the AD docket on in the United States. Pursuant to our comments. the Internet at http:// bilateral agreement with the State of We will post all comments we www.regulations.gov; or in person at the Design Authority, we have been notified receive, without change, to http:// Docket Operations office between 9 a.m. of the unsafe condition described in the www.regulations.gov, including any and 5 p.m., Monday through Friday, MCAI and service information personal information you provide. We except Federal holidays. The AD docket referenced above. We are issuing this will also post a report summarizing each contains this AD, the regulatory AD because we evaluated all pertinent substantive verbal contact we receive evaluation, any comments received, and information and determined the unsafe about this AD. condition exists and is likely to exist or other information. The street address for Authority for This Rulemaking the Docket Operations office (telephone develop on other products of the same type design. (800) 647–5527) is in the ADDRESSES Title 49 of the United States Code section. Comments will be available in Differences Between the AD and the specifies the FAA’s authority to issue the AD docket shortly after receipt. MCAI or Service Information rules on aviation safety. Subtitle I, section 106, describes the authority of FOR FURTHER INFORMATION CONTACT: Tom We have reviewed the MCAI and the FAA Administrator. ‘‘Subtitle VII: Rodriguez, Aerospace Engineer, related service information and, in Aviation Programs,’’ describes in more International Branch, ANM–116, general, agree with their substance. But detail the scope of the Agency’s Transport Airplane Directorate, FAA, we might have found it necessary to use authority. 1601 Lind Avenue, SW., Renton, different words from those in the MCAI We are issuing this rulemaking under Washington 98057–3356; telephone to ensure the AD is clear for U.S. the authority described in ‘‘Subtitle VII, (425) 227–1137; fax (425) 227–1149. operators and is enforceable. In making Part A, Subpart III, Section 44701: these changes, we do not intend to differ SUPPLEMENTARY INFORMATION: General requirements.’’ Under that substantively from the information section, Congress charges the FAA with Discussion provided in the MCAI and related promoting safe flight of civil aircraft in service information. air commerce by prescribing regulations The European Aviation Safety Agency We might also have required different for practices, methods, and procedures (EASA), which is the Technical Agent actions in this AD from those in the the Administrator finds necessary for for the Member States of the European MCAI in order to follow FAA policies. safety in air commerce. This regulation Community, has issued EASA Any such differences are highlighted in is within the scope of that authority Airworthiness Directive 2009–0208, a NOTE within the AD. because it addresses an unsafe condition dated October 13, 2009 (referred to after that is likely to exist or develop on this as ‘‘the MCAI’’), to correct an unsafe FAA’s Determination of the Effective products identified in this rulemaking condition for the specified products. Date action. The MCAI states: An unsafe condition exists that requires the immediate adoption of this Several occurrences of untimely radio- Regulatory Findings AD. The FAA has found that the risk to altimeter lock-up have been reported, where We determined that this AD will not the failed radio-altimeter indicated a negative the flying public justifies waiving notice and comment prior to adoption of this have federalism implications under distance to the ground despite the aircraft Executive Order 13132. This AD will was flying at medium or high altitude. rule because lock-up of the radio- A locked radio-altimeter #1 leads to altimeter could interfere with critical not have a substantial direct effect on untimely inhibition of warnings that could be flight system annunciations and the States, on the relationship between displayed along with certain abnormal functions, which could cause the the national government and the States, conditions while the avionic system switches flightcrew to be unaware of possible or on the distribution of power and into landing mode during altitude cruise. system failures that could require urgent responsibilities among the various Investigation in order to determine the root flightcrew actions. Therefore, we levels of government. cause of radio-altimeter lock-up is in For the reasons discussed above, I progress. In the meantime, Dassault Aviation determined that notice and opportunity for public comment before issuing this certify this AD: has developed an operational procedure that ‘‘ in case of radio-altimeter #1 lock-up allows AD are impracticable and that good 1. Is not a significant regulatory the crew, by depowering radio-altimeter #1, cause exists for making this amendment action’’ under Executive Order 12866; to restore in flight the system warning effective in fewer than 30 days. 2. Is not a ‘‘significant rule’’ under the performance. DOT Regulatory Policies and Procedures Failure to comply with this interim flight Comments Invited (44 FR 11034, February 26, 1979); and procedure may cause the crew to be unaware This AD is a final rule that involves 3. Will not have a significant of possible system failures that could require requirements affecting flight safety, and economic impact, positive or negative, urgent crew’s actions. we did not precede it by notice and on a substantial number of small entities This AD mandates application of a new under the criteria of the Regulatory abnormal Airplane Flight Manual (AFM) opportunity for public comment. We procedure when radio-altimeter #1 lock-up invite you to send any written relevant Flexibility Act. occurs and prohibits dispatch of the data, views, or arguments about this AD. We prepared a regulatory evaluation aeroplane with any radio-altimeter Send your comments to an address of the estimated costs to comply with inoperative. listed under the ADDRESSES section. this AD and placed it in the AD docket.

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List of Subjects in 14 CFR Part 39 Compliance Material Incorporated by Reference (f) You are responsible for having the (j) None. Air transportation, Aircraft, Aviation actions required by this AD performed within safety, Safety. Issued in Renton, Washington, on the compliance times specified, unless the December 28, 2009. actions have already been done. Adoption of the Amendment Ali Bahrami, Actions Manager, Transport Airplane Directorate, ■ Accordingly, under the authority (g) Within 14 days after the effective date Aircraft Certification Service. delegated to me by the Administrator, of this AD: Revise the Limitations Section of [FR Doc. 2010–103 Filed 1–12–10; 8:45 am] the Dassault Falcon 7X Airplane Flight the FAA amends 14 CFR part 39 as BILLING CODE 4910–13–P follows: Manual (AFM) to include the following statement. This may be done by inserting a PART 39—AIRWORTHINESS copy of this AD in the AFM. DIRECTIVES ‘‘If radio-altimeter #1 lock-up conditions DEPARTMENT OF COMMERCE occur in flight, power off radio-altimeter #1, in accordance with the instructions of Falcon Bureau of Industry and Security ■ 1. The authority citation for part 39 7X AFM procedure 3–140–65. continues to read as follows: Dispatch of the airplane with any radio- 15 CFR Part 744 Authority: 49 U.S.C. 106(g), 40113, 44701. altimeter inoperative is prohibited.’’ Note 1: When a statement identical to that [Docket No. 0911171410–91427–01] § 39.13 [Amended] in paragraph (g) of this AD has been included RIN 0694–AE78 ■ in the general revisions of the AFM, the 2. The FAA amends § 39.13 by adding general revisions may be inserted into the the following new AD: Addition of Certain Persons on the AFM, and the copy of this AD may be Entity List: Addition of Persons Acting removed from the AFM. 2010–02–02 Dassault-Aviation: Contrary to the National Security or Amendment 39–16173. Docket No. Foreign Policy Interests of the United FAA–2009–1252; Directorate Identifier FAA AD Differences States and Entry Modified for 2009–NM–248–AD. Note 2: This AD differs from the MCAI and/or service information as follows: No Clarification Effective Date differences. AGENCY: Bureau of Industry and (a) This airworthiness directive (AD) becomes effective January 28, 2010. Other FAA AD Provisions Security, Commerce. ACTION: Final rule. Affected ADs (h) The following provisions also apply to this AD: SUMMARY: This rule amends the Export (b) None. (1) Alternative Methods of Compliance Administration Regulations (EAR) by Applicability (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane adding additional persons to the Entity (c) This AD applies to Dassault-Aviation Directorate, FAA, has the authority to List (Supplement No. 4 to Part 744) on Model Falcon 7X airplanes, certificated in approve AMOCs for this AD, if requested the basis of Section 744.11 of the EAR. any category, all serial numbers. using the procedures found in 14 CFR 39.19. These persons that are added to the Subject Send information to ATTN: Tom Rodriguez, Entity List have been determined by the Aerospace Engineer, International Branch, U.S. Government to be acting contrary (d) Air Transport Association (ATA) of ANM–116, Transport Airplane Directorate, America Code 34: Navigation. to the national security or foreign policy FAA, 1601 Lind Avenue, SW., Renton, interests of the United States. This rule Reason Washington 98057–3356; telephone (425) 227–1137; fax (425) 227–1149. Before using also amends one entry by adding an (e) The mandatory continued airworthiness any approved AMOC on any airplane to additional address for this person listed information (MCAI) states: which the AMOC applies, notify your on the Entity List. Several occurrences of untimely radio- principal maintenance inspector (PMI) or The Entity List provides notice to the altimeter lock-up have been reported, where principal avionics inspector (PAI), as public that certain exports, reexports, the failed radio-altimeter indicated a negative appropriate, or lacking a principal inspector, and transfers (in-country) to parties distance to the ground despite the aircraft your local Flight Standards District Office. was flying at medium or high altitude. identified on the Entity List require a The AMOC approval letter must specifically license from the Bureau of Industry and A locked radio-altimeter #1 leads to reference this AD. untimely inhibition of warnings that could be (2) Airworthy Product: For any requirement Security (BIS) and that availability of displayed along with certain abnormal in this AD to obtain corrective actions from license exceptions in such transactions conditions while the avionic system switches a manufacturer or other source, use these is limited. into landing mode during altitude cruise. actions if they are FAA-approved. Corrective DATES: Effective Date: This rule is Investigation in order to determine the root actions are considered FAA-approved if they effective January 13, 2010. Although cause of radio-altimeter lock-up is in are approved by the State of Design Authority progress. In the meantime, Dassault Aviation there is no formal comment period, (or their delegated agent). You are required public comments on this regulation are has developed an operational procedure that to assure the product is airworthy before it in case of radio-altimeter #1 lock-up allows is returned to service. welcome on a continuing basis. the crew, by depowering radio-altimeter #1, (3) Reporting Requirements: For any ADDRESSES: You may submit comments, to restore in flight the system warning reporting requirement in this AD, under the identified by RIN 0694–AE78, by any of performance. provisions of the Paperwork Reduction Act the following methods: Failure to comply with this interim flight (44 U.S.C. 3501 et seq.), the Office of E-mail: [email protected] procedure may cause the crew to be unaware Management and Budget (OMB) has Include ‘‘RIN 0694–AE78’’ in the subject of possible system failures that could require approved the information collection line of the message. urgent crew’s actions. requirements and has assigned OMB Control Fax: (202) 482–3355. Please alert the This AD mandates application of a new Number 2120–0056. abnormal Airplane Flight Manual (AFM) Regulatory Policy Division, by calling procedure when radio-altimeter #1 lock-up Related Information (202) 482–2440, if you are faxing occurs and prohibits dispatch of the (i) Refer to MCAI EASA Airworthiness comments. aeroplane with any radio-altimeter Directive 2009–0208, dated October 13, 2009, Mail or Hand Delivery/Courier: inoperative. for related information. Timothy Mooney, U.S. Department of

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Commerce, Bureau of Industry and person who has addresses in both China Rd, Huatong Bldg, 19/F, Louhu Dist, Security, Regulatory Policy Division, and Hong Kong. The sixteen entries Shenzhen, China 518001; and 169 14th St. & Pennsylvania Avenue, NW., added to the Entity List consist of one Fucheng Rd, Fenggu Bldg., 7/F, Room 2705, Washington, DC 20230, person in Armenia, two persons in Mianyang, China 621000; and Zhi Chun Attn: RIN 0694–AE78. Send comments China, seven persons in Hong Kong, Rd, No 2 Bldg of Hoajing jiayuan, Suite regarding the collection of information four persons in Malaysia and two #804, Haidian Dist, Beijing, China associated with this rule, including persons in Singapore. 100086; and 40 North Chang’an Rd, suggestions for reducing the burden, to The ERC reviewed § 744.11(b) Xi’an Electronics Plaza Suite #516, Jasmeet K. Seehra, Office of (Criteria for revising the Entity List) in Xi’an, China 710061; and 9 Huapu Rd, Management and Budget (OMB), by making the determination to add these Chengbei Electronics & Apparatus Mall, e-mail to persons to the Entity List. Under that 1/F Suite #39, Chengdu, China 610081; [email protected], or by paragraph, entities for which there is and 2 North Linping Rd Bldg 1. Suite fax to (202) 395–7285; and to the reasonable cause to believe, based on #1706, Hongkou Dist, Shanghai, China Regulatory Policy Division, Bureau of specific and articulable facts, that the 200086 (See alternate address under Industry and Security, Department of entity has been involved, is involved, or Hong Kong); and Commerce, 14th St. & Pennsylvania poses a significant risk of being or (2) Wong Yung Fai, a.k.a., Tonny Avenue, NW., Room 2705, Washington, becoming involved in activities that are Wong, Unit 12B, Block 11, East Pacific DC 20230. Comments on this collection contrary to the national security or Garden, Xiang Lin Road, Futian District, of information should be submitted foreign policy interests of the United Shenzhen, China. separately from comments on the final States and those acting on behalf of such Hong Kong rule (i.e. RIN 0694–AE78)—all entities may be added to the Entity List comments on the latter should be pursuant to § 744.11. (1) Centre Bright Electronics Company submitted by one of the three methods Paragraph (b) of § 744.11 includes an Limited, Unit 7A, Nathan Commercial outlined above. illustrative list of activities that could be Building 430–436 Nathan Road, FOR FURTHER INFORMATION CONTACT: contrary to the national security or Kowloon, Hong Kong; and Room D, Elizabeth Scott Sangine, End-User foreign policy interests of the United Block 1, 6/F International Industrial Review Committee, Office of the States. This illustrative list of activities Centre, 2–8 Kwei Tei Street, Shatin New Assistant Secretary, Export of concern is described under Territories, Hong Kong; Administration, Bureau of Industry and paragraphs (b)(1)–(b)(5). The persons (2) Chitron Electronics Company Ltd, Security, Department of Commerce, being added to the Entity List under this a.k.a., Chi-Chuang Electronics Company Phone: (202) 482–3343, Fax: (202) 482– rule have been determined by the ERC Ltd (Chitron-Shenzhen), 6 Shing Yip St. 3911, E-mail: [email protected]. to be involved in activities that could be Prosperity Plaza 26/F, Suite #06, Kwun contrary to the national security or SUPPLEMENTARY INFORMATION: Tong, Kowloon, Hong Kong (See foreign policy interests of the United alternate address under China); Background States. (3) Exodus Microelectronics Company The Entity List provides notice to the Additions to the Entity List Limited, Unit 9B, Nathan Commercial Building, 430–436 Nathan Road, public that certain exports, reexports, This rule implements the decision of and transfers (in-country) to parties Kowloon, Hong Kong; and Unit 6B, the ERC to add fifteen persons under Block 1, International Centre 2–8 Kwei identified on the Entity List require a sixteen entries to the Entity List on the license from the Bureau of Industry and Tei Street, Shatin, New Territories, basis of § 744.11 of the EAR. For all of Hong Kong; and Unit 6B, Block 1, Security (BIS) and that availability of the fifteen persons added to the Entity license exceptions in such transactions International Industrial Centre, 2–8 List, the ERC specifies a license Kwei Tei Street, Shatin, Hong Kong; is limited. Persons are placed on the requirement for all items subject to the (4) Hong Chun Tai, Unit 27B, Block 8, Entity List on the basis of certain EAR and establishes a license Monte Vista, 9 Sha On Street, Ma On sections of part 744 (Control Policy: application review policy of a Shan New Territories, Hong Kong; and End-User and End-Use Based) of the presumption of denial. The license Unit 7A, Nathan Commercial Building, EAR. requirement applies to any transaction 430–436 Nathan Road Kowloon, Hong The End-User Review Committee in which items are to be exported, Kong; and Room D, Block 1, 6/F (ERC), composed of representatives of reexported or transferred (in-country) to International Industrial Centre, 2–8 the Departments of Commerce (Chair), such persons or in which such persons Kwei Tei Street, Shatin, New State, Defense, Energy and, where act as purchaser, intermediate Territories, Hong Kong; and Unit 9B, appropriate, the Treasury, makes all consignee, ultimate consignee, or end- Nathan Commercial Building, 430–436 decisions regarding additions to, user. In addition, no license exceptions Nathan Road Kowloon, Hong Kong; removals from or changes to the Entity are available for shipments to those (5) Victory Wave Holdings Limited, List. The ERC makes all decisions to add persons being added to the Entity List. an entry to the Entity List by majority Specifically, this rule adds the Unit 2401 A, Park-In Commercial vote and all decisions to remove or following fifteen persons under sixteen Centre, 56 Dundas Street, Hong Kong; modify an entry by unanimous vote. entries to the Entity List: and Unit 2401A, 24/F Park-In Commercial Centre, 56 Dundas Street, ERC Entity List Decisions Armenia Mongkok, Kowloon, Hong Kong; The ERC made a determination to add (1) Bold Bridge International, LLC, (6) Wong Wai Chung, a.k.a., David fifteen persons under sixteen entries to Room 463, H. Hakobyan 3, Yerevan, Wong, Unit 27B, Block 8, Monte Vista, the Entity List on the basis of § 744.11 Armenia. 9 Sha On Street, Ma On Shan, New (License Requirements that Apply to Territories, Hong Kong; and Unit 7A, Entities Acting Contrary to the National China Nathan Commercial Building 430–436 Security or Foreign Policy Interests of (1) Chitron Electronics Company Ltd, Nathan Road, Kowloon, Hong Kong; and the United States) of the EAR. The a.k.a., Chi-Chuang Electronics Company Room D, Block 1, 6/F International sixteenth entry is to account for one Ltd (Chitron-Shenzhen), 2127 Sungang Industrial Centre, 2–8 Kwei Tei Street,

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Shatin, New Territories, Hong Kong; Unit 11, No. 35 South Iranshahr St, 4. The provisions of the and Tehran, Iran. Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed (7) Wong Yung Fai, a.k.a., Tonny Savings Clause Wong, Unit 27B, Block 8, Monte Vista, rulemaking, the opportunity for public 9 Sha On Street, Ma On Shan, New Shipments of items removed from participation, and a delay in effective Territories, Hong Kong; and Unit 1006, eligibility for a License Exception or date, are inapplicable because this 10/F Carnarvon Plaza, 20 Carnarvon export or reexport without a license regulation involves a military or foreign Road, TST, Kowloon, Hong Kong; and (NLR) as a result of this regulatory affairs function of the United States. Unit 7A, Nathan Commercial Building, action that were on dock for loading, on (See 5 U.S.C. 553(a)(1)). Further, no 430–436 Nathan Road, Kowloon, Hong lighter, laden aboard an exporting or other law requires that a notice of Kong; and Room D, Block 1, 6/F reexporting carrier, or en route aboard a proposed rulemaking and an International Industrial Centre, 2–8 carrier to a port of export or reexport, on opportunity for public comment be Kwei Tei Street, Shatin, New January 13, 2010, pursuant to actual given for this rule. Because a notice of Territories, Hong Kong; and Unit 9B, orders for export or reexport to a foreign proposed rulemaking and an Nathan Commercial Building 430–436 destination, may proceed to that opportunity for public comment are not Nathan Road, Kowloon, Hong Kong; and destination under the previous required to be given for this rule by 5 Unit 2401A, 24/F Park-In Commercial eligibility for a License Exception or U.S.C. 553, or by any other law, the Centre 56 Dundas Street, Mongkok, export or reexport without a license analytical requirements of the Kowloon, Hong Kong. (NLR) so long as they are exported or Regulatory Flexibility Act, 5 U.S.C. 601 reexported before February 12, 2010. et. seq., are not applicable. Malaysia Any such items not actually exported or List of Subjects in 15 CFR Part 744 (1) Alex Ramzi, Suite 33–01, Menara reexported before midnight, on February Keck Seng, 203 Jalan Bukit Bintang, 12, 2010, require a license in accordance Exports, Reporting and recordkeeping Kuala Lumpur, Malaysia 55100; with this rule. requirements, Terrorism. (2) Amir Ghasemi, Suite 33–01, Although the Export Administration ■ Accordingly, part 744 of the Export Menara Keck Seng, 203 Jalan Bukit Act expired on August 20, 2001, the Administration Regulations (15 CFR Bintang, Kuala Lumpur, Malaysia President, through Executive Order parts 730–774) is amended as follows: 55100; 13222 of August 17, 2001, 3 CFR, 2001 (3) Evertop Services Sdn Bhd, Suite Comp., p. 783 (2002), as extended by the PART 744—[AMENDED] 33–01, Menara Keck Seng, 203 Jalan Notice of August 13, 2009, 74 FR 41325 ■ 1. The authority citation for 15 CFR Bukit Bintang, Kuala Lumpur, Malaysia (August 14, 2009), has continued the part 744 continues to read as follows: 55100; and Export Administration Regulations in (4) Majid Kakavand, Suite 33–01, effect under the International Authority: 50 U.S.C. app. 2401 et seq.; 50 Menara Keck Seng, 203 Jalan Bukit Emergency Economic Powers Act. U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 Bintang, Kuala Lumpur, Malaysia Rulemaking Requirements U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 55100. 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 1. This rule has been determined to be Singapore 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 not significant for purposes of Executive FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. (1) Microsun Electronics Pte., Ltd, Sim Order 12866. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. Lim Tower, 10 Jalan Besar, Singapore 2. Notwithstanding any other 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 208787; and provision of law, no person is required Comp., p. 228; E.O. 13099, 63 FR 45167, 3 (2) Opto Electronics Pte. Ltd, Suite to respond to nor be subject to a penalty CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 11–08, Sim Lim Tower, 10 Jalan Besar, for failure to comply with a collection 44025, 3 CFR, 2001 Comp., p. 783; E.O. of information, subject to the 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. Singapore 208787. 786; Notice of August 13, 2009, 74 FR 41325 A BIS license is required for the requirements of the Paperwork (August 14, 2009); Notice of November 6, export, reexport or transfer (in-country) Reduction Act of 1995 (44 U.S.C. 3501 2009, 74 FR 58187 (November 10, 2009). of any item subject to the EAR to any et seq.) (PRA), unless that collection of of the persons listed above, including information displays a currently valid ■ 2. Supplement No. 4 to part 744 is any transaction in which any of the Office of Management and Budget amended: listed persons will act as purchaser, (OMB) Control Number. This regulation (a) By adding, in alphabetical order, intermediate consignee, ultimate involves collections previously the country of Armenia and one consignee, or end-user of the items. This approved by the OMB under control Armenian entity; listing of these persons also prohibits numbers 0694–0088, ‘‘Multi-Purpose (b) By adding under China, People’s the use of License Exceptions (see part Application,’’ which carries a burden Republic of, in alphabetical order, two 740 of the EAR) for exports, reexports hour estimate of 58 minutes to prepare Chinese entities; and transfers (in-country) of items and submit form BIS–748. (c) By adding under Hong Kong, in subject to the EAR involving such Miscellaneous and recordkeeping alphabetical order, seven Hong Kong persons. activities account for 12 minutes per entities; submission. Total burden hours (d) By adding under Malaysia, in Amendment to the Entity List associated with the Paperwork alphabetical order, four Malaysian This rule also amends one Iranian Reduction Act and Office and entities; entry currently on the Entity List by Management and Budget control (e) By adding under Singapore, in adding an additional address for the number 0694–0088 are expected to alphabetical order, two Singaporean person listed, as follows: increase slightly as a result of this rule. entities; and 3. This rule does not contain policies (f) By revising under Iran, in Iran with Federalism implications as that alphabetical order, one Iranian entity (1) Arash Dadgar, No. 10, 64th St., term is defined in Executive Order ‘‘Arash Dadgar, No. 10, 64th St., Yousafabad, Tehran, Iran, 14638, and 13132. Yousafabad, Tehran, Iran, 14638’’.

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The additions and revision read as follows:

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST

Federal Register Country Entity License requirement License review policy citation

******* Armenia ...... Bold Bridge International, LLC, Room 463, For all items subject Presumption of denial. 75 FR [INSERT FR H. Hakobyan 3, Yerevan, Armenia. to the EAR. (See PAGE NUMBER] § 744.11 of the January 13, 2010. EAR).

******* China, People’s Re- Chitron Electronics Company Ltd, a.k.a., Chi- For all items subject Presumption of denial. 75 FR [INSERT FR public of. Chuang Electronics Company Ltd. to the EAR. (See PAGE NUMBER] (Chitron Shenzhen), 2127 Sungang Rd, § 744.11 of the January 13, 2010. Huatong Bldg, 19/F Louhu Dist, EAR). Shenzhen, China 518001; and 169 Fucheng Rd, Fenggu Bldg, 7/F, Mianyang, China 621000; and Zhi Chun Rd, No 2 Bldg of Hoajing jiayuan, Suite #804, Haidian Dist, Beijing, China 100086; and 40 North Chang’an Rd, Xi’an Electronics Plaza Suite #516, Xi’an, China 710061; and 9 Huapu Rd, Chengbei Electronics & Apparatus Mall, 1/F Suite #39, Chengdu, China 610081; and 2 North Linping Rd, Bldg 1, Suite #1706, Hongkou Dist, Shanghai, China 200086 (See alternate address under Hong Kong).

******* Wong Yung Fai, a.k.a., Tonny Wong, Unit For all items subject Presumption of denial. 75 FR [INSERT FR 12B, Block 11, East Pacific Garden, Xiang to the EAR. (See PAGE NUMBER] Lin Road, Futian District, Shenzhen, China. § 744.11 of the January 13, 2010. EAR).

******* Hong Kong ...... Centre Bright Electronics Company Limited, For all items subject Presumption of denial. 75 FR [INSERT FR Unit 7A, Nathan Commercial Building 430– to the EAR. (See PAGE NUMBER] 436 Nathan Road, Kowloon, Hong Kong; § 744.11 of the January 13, 2010. and Room D, Block 1, 6/F International In- EAR). dustrial Centre, 2–8 Kwei Tei Street, Shatin New Territories, Hong Kong. Chitron Electronics Company Ltd, a.k.a., Chi- For all items subject Presumption of denial. 75 FR [INSERT FR Chuang Electronics Company Ltd (Chitron- to the EAR. (See PAGE NUMBER] Shenzhen), 6 Shing Yip St. Prosperity § 744.11 of the January 13, 2010. Plaza 26/F, Suite #06, Kwun Tong, EAR). Kowloon, Hong Kong (See alternate ad- dress under China).

******* Exodus Microelectronics Company Limited, For all items subject Presumption of denial. 75 FR [INSERT FR Unit 9B, Nathan Commercial Building 430– to the EAR. (See PAGE NUMBER] 436 Nathan Road, Kowloon, Hong Kong; § 744.11 of the January 13, 2010. and Exodus Microelectronics Company EAR). Limited, Unit 6B, Block 1, International Centre 2–8 Kwei Tei Street, Shatin, New Territories, Hong Kong; and Exodus Micro- electronics Company Limited, Unit 6B, Block 1, International Industrial Centre, 2– 8 Kwei Tei Street, Shatin, Hong Kong.

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SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued

Federal Register Country Entity License requirement License review policy citation

******* Hong Chun Tai, Unit 27B, Block 8, Monte For all items subject Presumption of denial. 75 FR [INSERT FR Vista, 9 Sha On Street, Ma On Shan New to the EAR. (See PAGE NUMBER] Territories, Hong Kong; and Unit 7A, Na- § 744.11 of the January 13, 2010. than Commercial Building, 430–436 Na- EAR). than Road Kowloon, Hong Kong; and Room D, Block 1, 6/F International Indus- trial Centre, 2–8 Kwei Tei Street, Shatin, New Territories, Hong Kong; and Unit 9B, Nathan Commercial Building, 430–436 Na- than Road Kowloon, Hong Kong.

******* Victory Wave Holdings Limited, Unit 2401 A, For all items subject Presumption of denial. 75 FR [INSERT FR Park-In Commercial Centre, 56 Dundas to the EAR. (See PAGE NUMBER] Street, Hong Kong; and Unit 2401A, 24/F § 744.11 of the January 13, 2010. Park-In Commercial Centre, 56 Dundas EAR). Street, Mongkok, Kowloon, Hong Kong.

******* Wong Wai Chung, a.k.a., David Wong, Unit For all items subject Presumption of denial. 75 FR [INSERT FR 27B, Block 8, Monte Vista, 9 Sha On to the EAR. (See PAGE NUMBER] Street, Ma On Shan, New Territories, § 744.11 of the January 13, 2010. Hong Kong; and Unit 7A, Nathan Com- EAR). mercial Building 430–436 Nathan Road, Kowloon, Hong Kong; and Room D, Block 1, 6/F International Industrial Centre, 2–8 Kwei Tei Street, Shatin, New Territories, Hong Kong. Wong Yung Fai, a.k.a., Tonny Wong, Unit For all items subject Presumption of denial. 75 FR [INSERT FR 27B, Block 8, Monte Vista, 9 Sha On to the EAR. (See PAGE NUMBER] Street, Ma On Shan, New Territories, § 744.11 of the January 13, 2010. Hong Kong; and Unit 1006, 10/F EAR). Carnarvon Plaza, 20 Carnarvon Road, TST, Kowloon, Hong Kong; and Unit 7A, Nathan Commercial Building, 430–436 Na- than Road, Kowloon, Hong Kong; and Room D, Block 1, 6/F International Indus- trial Centre, 2–8 Kwei Tei Street, Shatin, New Territories, Hong Kong; and Unit 9B, Nathan Commercial Building 430–436 Na- than Road, Kowloon, Hong Kong; and Unit 2401A, 24/F Park-In Commercial Centre, 56 Dundas Street, Mongkok, Kowloon, Hong Kong.

******* Iran ...... Arash Dadgar, No. 10, 64th St., Yousafabad, For all items subject Presumption of denial. 73 FR 54506, 9/22/08 Tehran, Iran, 14638, and Unit 11, No. 35 to the EAR. (See 75 FR [INSERT FR South Iranshahr St., Tehran, Iran. § 744.11 of the PAGE NUMBER] EAR). January 13, 2010.

******* Malaysia ...... Alex Ramzi, Suite 33–01, Menara Keck For all items subject Presumption of denial. 75 FR [INSERT FR Seng, 203 Jalan Bukit Bintang, Kuala to the EAR. (See PAGE NUMBER] Lumpur, Malaysia 55100. § 744.11 of the January 13, 2010. EAR). Amir Ghasemi, Suite 33–01, Menara Keck For all items subject Presumption of denial. 75 FR [INSERT FR Seng, 203 Jalan Bukit Bintang, Kuala to the EAR. (See PAGE NUMBER] Lumpur, Malaysia 55100. § 744.11 of the January 13, 2010. EAR).

******* Evertop Services Sdn Bhd, Suite 33–01, For all items subject Presumption of denial. 75 FR [INSERT FR Menara Keck Seng, 203 Jalan Bukit to the EAR. (See PAGE NUMBER] Bintang, Kuala Lumpur, Malaysia 55100. § 744.11 of the January 13, 2010. EAR).

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SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued

Federal Register Country Entity License requirement License review policy citation

******* Majid Kakavand, Suite 33–01, Menara Keck For all items subject Presumption of denial. 75 FR [INSERT FR Seng, 203 Jalan Bukit Bintang, Kuala to the EAR. (See PAGE NUMBER] Lumpur, Malaysia 55100. § 744.11 of the January 13, 2010. EAR).

******* Singapore ...... Microsun Electronics Pte. Ltd, Sim Lim For all items subject Presumption of denial. 75 FR [INSERT FR Tower, 10 Jalan Besar, Singapore 208787. to the EAR. (See PAGE NUMBER] § 744.11 of the January 13, 2010. EAR).

******* Opto Electronics Pte. Ltd, Suite 11–08, Sim For all items subject Presumption of denial. 75 FR [INSERT FR Lim Tower, 10 Jalan Besar, Singapore to the EAR. (See PAGE NUMBER] 208787. § 744.11 of the January 13, 2010. EAR).

*******

Dated: January 7, 2010. Background and (3) of this section will expire on Matthew S. Borman, September 3, 2012. The temporary regulation that is the Deputy Assistant Secretary, for Export * * * * * Administration. subject to this correction is under Guy R. Traynor, [FR Doc. 2010–455 Filed 1–12–10; 8:45 am] section 1502 of the Internal Revenue Federal Register Liaison, Publications & BILLING CODE 3510–35–P Code. Regulations Branch, Legal Processing Need for Correction Division, Associate Chief Counsel (Procedure & Administration). As published September 4, 2009 (74 DEPARTMENT OF THE TREASURY [FR Doc. 2010–416 Filed 1–12–10; 8:45 am] FR 45757), temporary regulations (TD BILLING CODE 4830–01–P Internal Revenue Service 9458), contains an error which may prove to be misleading and is in need 26 CFR Part 1 of clarification. DEPARTMENT OF HOMELAND [TD 9458] List of Subjects in 26 CFR part 1 SECURITY RIN 1545–BI72 Income taxes, Reporting and Coast Guard Modification to Consolidated Return recordkeeping requirements. 33 CFR Part 27 Regulation Permitting an Election To Correction of Publication Treat a Liquidation of a Target, [Docket No. USCG–2009–0891] ■ Followed by a Recontribution to a New Accordingly, 26 CFR part 1 is RIN 1625–AB40 Target, as a Cross-Chain corrected by making the following Reorganization correcting amendment. Federal Civil Penalties Inflation AGENCY: Adjustment Act—2009 Implementation Internal Revenue Service (IRS), PART 1—INCOME TAXES Treasury. AGENCY: Coast Guard, DHS. ACTION: Correcting amendment. ■ Paragraph 1. The authority for part 1 ACTION: Final rule; correction. continues to read in part as follows: SUMMARY: This document contains a SUMMARY: The Coast Guard is correcting correction to temporary regulations (TD Authority: 26 U.S.C. 7805 * * * a final rule that appeared in the Federal 9458), which were published in the Register of December 23, 2009 (74 FR Federal Register on Friday, September ■ Par. 2. Paragraph (f)(5)(ii)(G) is added 68150). The document concerned the 4, 2009, relating to modification to following paragraph (f)(5)(ii)(F)(3), to adjustment of fines and other civil consolidated return regulation read as follows: monetary penalties. permitting an election to treat a § 1.1502–13T Intercompany transactions DATES: Effective January 13, 2010. liquidation of a target, followed by a (temporary). FOR FURTHER INFORMATION CONTACT: Ms. recontribution to a new reorganization. * * * * * Heather Young, CG–5232, Coast Guard; DATES: The correction is effective telephone 202–372–1022. (f) * * * January 13, 2010, and is applicable SUPPLEMENTARY INFORMATION: In FR Doc. beginning September 4, 2009. (5) * * * E9–30493 appearing on page 68150 in FOR FURTHER INFORMATION CONTACT: Guy (ii) * * * the second column under DATES, correct Traynor at (202) 622–3693 (not a toll- ‘‘ (G) Expiration date. Paragraphs This final rule is effective 30 days after free number). December 23, 2009’’ to read ‘‘This final (f)(5)(ii)(B), (B)(1), (B)(2) and (F)(1), (2), SUPPLEMENTARY INFORMATION: rule is effective January 22, 2010’’.

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Dated: January 6, 2010. A.P. Construction, Inc., on behalf of DEPARTMENT OF HOMELAND Mark W. Skolnicki, Atlantic County who owns and operates SECURITY Commander, U.S. Coast Guard, Acting Chief, this double-leaf bascule drawbridge, has Office of Regulations and Administrative Law. requested a temporary deviation from Coast Guard [FR Doc. 2010–432 Filed 1–12–10; 8:45 am] the current operating regulations set out BILLING CODE 9110–04–P in 33 CFR 117.733(g), to facilitate deck 33 CFR Part 117 repairs. [USCG–2009–1107] Under this temporary deviation, the DEPARTMENT OF HOMELAND RIN 1625–AA09 SECURITY drawbridge will provide a partial opening of the lift spans for vessels. The Drawbridge Operation Regulations; Coast Guard deck repairs require immobilizing half Curtis Creek, Baltimore, MD of the draw span to single-leaf operation 33 CFR Part 117 beginning at 7 a.m. on Wednesday, AGENCY: Coast Guard, DHS. January 20, 2010, until and including 11 ACTION: Notice of temporary deviation [Docket No. USCG–2009–1093] p.m. on Saturday, April 17, 2010. from regulations. Drawbridge Operation Regulation; Consequently, passage under the SUMMARY: The Commander, Fifth Coast Intracoastal Waterway (ICW), Inside bridge will be limited to a 25-foot width Guard District, has issued a temporary Thorofare, Ventnor City, NJ for the duration of the project. deviation from the regulations AGENCY: Coast Guard, DHS. The single-bascule leaf not under governing the operation of the I695 Bridge across Curtis Creek, mile 0.9, at ACTION: Notice of temporary deviation repair will continue to open for vessels. from regulations. Prior to an opening of this single- Baltimore, MD. The deviation is bascule leaf, a work barge occupying the necessary to facilitate mechanical SUMMARY: The Commander, Fifth Coast channel underneath this span will also repairs to the bridge. This temporary Guard District, has issued a temporary be moved. Finally, the drawbridge will deviation allows the drawbridge to deviation from the regulations open in the event of an emergency. remain in the closed position during the governing the operation of the Dorset deviation period. Bridge opening data, supplied by Avenue Bridge, at ICW mile 71.2, across DATES: This deviation is effective from Inside Thorofare, at Ventnor City. This Atlantic County and reviewed by the 8 a.m. on January 9, 2010, to 8 p.m. on bridge is a double-leaf bascule U.S. Coast Guard, revealed a small March 28, 2010. amount of vessel openings of the draw drawbridge. The deviation restricts the ADDRESSES: Documents mentioned in span from January 2009 to April 2009. operation of the draw span to facilitate this preamble as being available in the Specifically, the bridge opened for structural rehabilitation to one of the docket are part of docket USCG–2009– bascule leafs. vessels 4, 11, 11, and 19 times during 1107 and are available online by going DATES: This deviation is effective from the months of January to April 2009, to http://www.regulations.gov, inserting 7 a.m. on January 20, 2010 until 11 p.m. respectively. Vessels that can pass USCG–2009–1107 in the ‘‘Keyword’’ on April 17, 2010. under the bridge without a full bridge box, and then clicking ‘‘Search.’’ This ADDRESSES: Documents mentioned in opening may continue to do so at all material is also available for inspection this preamble as being available in the times. Mariners requiring the full or copying the Docket Management docket are part of docket USCG–2009– opening of the lift spans will be directed Facility (M–30), U.S. Department of 1093 and are available online by going to use the Atlantic Ocean as the Transportation, West Building Ground to http://www.regulations.gov, inserting alternate route. Floor, Room W12–140, 1200 New Jersey USCG–2009–1093 in the ‘‘Keyword’’ box The Coast Guard will inform the users Avenue, SE., Washington, DC 20590, and then clicking ‘‘Search’’. They are of the waterway through our Local and between 9 a.m. and 5 p.m., Monday also available for inspection or copying Broadcast Notices to Mariners of the through Friday, except Federal holidays. at the Docket Management Facility (M– closure periods for the bridge so that FOR FURTHER INFORMATION CONTACT: If 30), U.S. Department of Transportation, vessels can arrange their transits to you have questions on this rule, call or West Building Ground Floor, Room minimize any impact caused by the e-mail Mr. Bill H. Brazier, Bridge W12–140, 1200 New Jersey Avenue, SE., temporary deviation. Management Specialist, Fifth Coast Washington, DC 20590, between 9 a.m. Guard District; telephone 757–398– and 5 p.m., Monday through Friday, In accordance with 33 CFR 117.35(e), 6422, e-mail [email protected]. If except Federal holidays. the drawbridge must return to its regular you have questions on viewing the FOR FURTHER INFORMATION CONTACT: If operating schedule immediately at the docket, call Renee V. Wright, Program you have questions on this rule, call or end of the designated time period. This Manager, Docket Operations, telephone e-mail Mrs. Sandra Elliott, Bridge deviation from the operating regulations (202) 366–9826. is authorized under 33 CFR 117.35. Management Specialist, Fifth District; SUPPLEMENTARY INFORMATION: The Coast Guard; telephone 757–398–6557, Dated: December 18, 2009. Maryland Transportation Authority, e-mail [email protected]. If you Waverly W. Gregory, Jr., who owns and operates this double-leaf have questions on viewing the docket, Chief, Bridge Administration Branch, By bascule drawbridge, has requested a call Renee V. Wright, Program Manager, direction of the Commander, Fifth Coast temporary deviation from the current Docket Operations, telephone 202–366– Guard District. operating regulations set forth in 33 CFR 9826. [FR Doc. 2010–434 Filed 1–12–10; 8:45 am] 117.557 to facilitate mechanical repairs. SUPPLEMENTARY INFORMATION: The The I695 Bridge, a double-leaf bascule BILLING CODE 9110–04–P Dorset Avenue Bridge has a vertical drawbridge, has a vertical clearance in clearance in the closed position of 9 feet the closed position to vessels of 58 feet, at mean high water and 12 feet at mean above mean high water. The draw of the low water. bridge shall open on signal if at least a

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one-hour notice is given to the Dubuque Railroad Drawbridge, across waterway consists primarily of Maryland Transportation Authority in the Upper Mississippi River, Mile 579.9, commercial tows and recreational Baltimore, as required by 33 CFR Dubuque, Iowa. The deviation is watercraft. These interests will not be 117.557. necessary to allow time for performing significantly impacted due to the Under this temporary deviation, the needed maintenance and repairs to the reduced navigation in winter months. drawbridge will be maintained in the bridge. This deviation allows the bridge This temporary deviation has been closed position to vessels to facilitate to open on signal if at least 24 hours coordinated with waterway users. No repairs to trunnion bearings on two advance notice is given from 12:01 a.m. objections were received. separate closure periods. The first January 15, 2010 until 9 a.m., March 15, In accordance with 33 CFR 117.35(e), period will begin at 8 a.m. on January 2010. the drawbridge must return to its regular 9, 2010, until and including 8 p.m. on DATES: This deviation is effective from operating schedule immediately at the February 6, 2010; and the second period 12:01 a.m. January 15, 2010 until 9 a.m., end of the designated time period. This will start again at 8 a.m. on March 1, March 15, 2010. deviation from the operating regulations 2010, until and including 8 p.m. on ADDRESSES: Documents mentioned in is authorized under 33 CFR 117.35. March 28, 2010. Vessels may pass this preamble as being available in the Dated: 22 December 2009. underneath the bridge while the bridge docket are part of docket USCG–2009– is in the closed position. There are no Roger K. Wiebusch, 1097 and are available online by going Bridge Administrator. alternate routes for vessels transiting to http://www.regulations.gov, inserting [FR Doc. 2010–436 Filed 1–12–10; 8:45 am] this section of Curtis Creek and the USCG–2009–1097 in the ‘‘Keyword’’ and bridge will not be able to open in the then clicking ‘‘Search’’. They are also BILLING CODE 9110–04–P event of an emergency. available for inspection or copying at Coast Guard vessels bound for the the Docket Management Facility (M–30), Coast Guard Yard at Curtis Bay, as well DEPARTMENT OF HOMELAND U.S. Department of Transportation, SECURITY as a significant amount of commercial West Building Ground Floor, Room vessel traffic, must pass beneath the W12–140, 1200 New Jersey Avenue, SE., Coast Guard I695 Bridge. The Coast Guard has Washington, DC 20590, between 9 a.m. carefully coordinated the restrictions and 5 p.m., Monday through Friday, 33 CFR Part 165 with the Yard and the commercial users except Federal holidays. [Docket No. USCG–2009–1058] of the waterway. Additionally, the Coast FOR FURTHER INFORMATION CONTACT: If Guard will inform unexpected users of RIN 1625–AA11 you have questions on this rule, call or the waterway through our Local and e-mail Roger K. Wiebusch, Bridge Broadcast Notices to Mariners of the Regulated Navigation Area; U.S. Navy Administrator, Coast Guard; telephone closure periods for the bridge so that Submarines, Hood Canal, WA (314) 269–2378, e-mail vessels can arrange their transits to [email protected]. If you have AGENCY: Coast Guard, DHS. minimize any impact caused by the questions on viewing the docket, call ACTION: Interim rule with request for temporary deviation. In accordance with 33 CFR 117.35(e), Renee V. Wright, Program Manager, comments. the drawbridge must return to its regular Docket Operations, telephone (202) 366–9826. SUMMARY: The Coast Guard is operating schedule immediately at the establishing a regulated navigation area SUPPLEMENTARY INFORMATION: The end of the designated time period. This (RNA) covering the Hood Canal in Canadian National Railway Company deviation from the operating regulations Washington that will be in effect requested a temporary deviation for the is authorized under 33 CFR 117.35. whenever any U.S. Navy submarine is Dubuque Railroad Drawbridge, across Dated: December 24, 2009. operating in the Hood Canal and being the Upper Mississippi, mile 579.9, at escorted by the Coast Guard. The RNA Waverly W. Gregory, Jr., Dubuque, Iowa to open on signal if at is necessary to help ensure the safety Chief, Bridge Administration Branch, Fifth least 24 hours advance notice is given and security of the submarines, their Coast Guard District. in order to facilitate needed bridge Coast Guard security escorts, and the [FR Doc. 2010–437 Filed 1–12–10; 8:45 am] maintenance and repairs. The Dubuque maritime public in general. The RNA BILLING CODE 9110–04–P Railroad Drawbridge currently operates will do so by requiring all persons and in accordance with 33 CFR 117.5, which vessels located within the RNA to states the general requirement that DEPARTMENT OF HOMELAND follow all lawful orders and/or drawbridges shall open promptly and SECURITY directions given to them by Coast Guard fully for the passage of vessels when a security escort personnel. Coast Guard request to open is given in accordance with the subpart. In order to facilitate DATES: This rule is effective January 13, 2010. Comments and related material 33 CFR Part 117 the needed bridge work, the drawbridge must be kept in the closed-to-navigation must reach the Coast Guard on or before [Docket Number USCG–2009–1097] position. This deviation allows the April 13, 2010. Requests for public bridge to open on signal if at least 24 meetings must be received by the Coast Drawbridge Operation Regulations; hours advance notice is given from Guard on or before February 12, 2010. Upper Mississippi River, Dubuque, IA 12:01 a.m. January 15, 2010 until 9 a.m., ADDRESSES: You may submit comments AGENCY: Coast Guard, DHS. March 15, 2010. identified by docket number USCG– ACTION: Notice of temporary deviation There are no alternate routes for 2009–1058 using any one of the from regulations. vessels transiting this section of the following methods: Upper Mississippi River. (1) Federal eRulemaking Portal: SUMMARY: The Commander, Eighth The Dubuque Railroad Drawbridge, in http://www.regulations.gov. Coast Guard District has issued a the closed-to-navigation position, (2) Fax: 202–493–2251. temporary deviation from the regulation provides a vertical clearance of 19.9 feet (3) Mail: Docket Management Facility governing the operations of the above normal pool. Navigation on the (M–30), U.S. Department of

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Transportation, West Building Ground To submit your comment online, go to Regulatory Information Floor, Room W12–140, 1200 New Jersey http://www.regulations.gov, click on the The Coast Guard is issuing this Avenue, SE., Washington, DC 20590– ‘‘submit a comment’’ box, which will interim rule without prior notice and 0001. then become highlighted in blue. In the opportunity to comment pursuant to (4) Hand delivery: Same as mail ‘‘Document Type’’ drop down menu authority under section 4(a) of the address above, between 9 a.m. and 5 select ‘‘Proposed Rule’’ and insert Administrative Procedure Act (APA) (5 p.m., Monday through Friday, except ‘‘USCG–2009–1058’’ in the ‘‘Keyword’’ U.S.C. 553(b)). This provision Federal holidays. The telephone number box. Click ‘‘Search’’ then click on the authorizes an agency to issue a rule is 202–366–9329. balloon shape in the ‘‘Actions’’ column. without prior notice and opportunity to To avoid duplication, please use only If you submit comments by mail or hand comment when the agency for good one of these four methods. See the delivery, submit them in an unbound cause finds that those procedures are ‘‘Public Participation and Request for format, no larger than 81⁄2 by 11 inches, ‘‘impracticable, unnecessary, or contrary Comments’’ portion of the suitable for copying and electronic to the public interest.’’ Under 5 U.S.C. SUPPLEMENTARY INFORMATION section filing. If you submit comments by mail 553(b)(B), the Coast Guard finds that below for instructions on submitting and would like to know that they good cause exists for not publishing a comments. reached the Facility, please enclose a notice of proposed rulemaking (NPRM) with respect to this rule. Because the FOR FURTHER INFORMATION CONTACT: If stamped, self-addressed postcard or you have questions on this interim rule, envelope. We will consider all narrow confines of the Hood Canal call or e-mail LT Matthew N. Jones, Staff comments and material received during make it particularly difficult for the Attorney, Thirteenth Coast Guard the comment period and may change Coast Guard to escort U.S. Navy District; telephone 206–220–7155, e- this rule based on your comments. submarines through the canal without risk to the submarines, their Coast mail [email protected]. If you Viewing Comments and Documents have questions on viewing or submitting Guard escorts, or the general maritime public, immediate action is required to material to the docket, call Renee V. To view comments, as well as protect safety within the canal, and any Wright, Program Manager, Docket documents mentioned in this preamble delay would be contrary to the public Operations, telephone 202–366–9826. as being available in the docket, go to interest. SUPPLEMENTARY INFORMATION: http://www.regulations.gov, click on the For the same reason, under 5 U.S.C. ‘‘read comments’’ box, which will then 553(d)(3), the Coast Guard finds that Public Participation and Request for become highlighted in blue. In the Comments good cause exists for making this rule ‘‘Keyword’’ box insert ‘‘USCG–2009– effective less than 30 days after We encourage you to participate in 1058’’ and click ‘‘Search.’’ Click the publication in the Federal Register. this rulemaking by submitting ‘‘Open Docket Folder’’ in the ‘‘Actions’’ comments and related materials. All column. You may also visit the Docket Background and Purpose comments received will be posted, Management Facility in Room W12–140 U.S. Navy submarines frequently without change, to http:// on the ground floor of the Department operate in the Hood Canal. Due to the www.regulations.gov and will include of Transportation West Building, 1200 numerous safety and security concerns any personal information you have New Jersey Avenue, SE., Washington, involved with submarine operations provided. DC 20590, between 9 a.m. and 5 p.m., near shore in very restricted waters, the Monday through Friday, except Federal Coast Guard provides security escorts of Submitting Comments holidays. We have an agreement with submarines when operating in that area. If you submit a comment, please the Department of Transportation to use Security escorts of this type require the include the docket number for this the Docket Management Facility. Coast Guard personnel on-scene to make rulemaking (USCG–2009–1058), quick judgments about the intent of indicate the specific section of this Privacy Act vessels operating in close proximity to document to which each comment Anyone can search the electronic the submarines and decide, occasionally applies, and provide a reason for each form of comments received into any of with little information about the vessels suggestion or recommendation. You our dockets by the name of the or persons on board, whether or not may submit your comments and individual submitting the comment (or they pose a threat to the submarine. The material online (via http:// signing the comment, if submitted on narrow confines of the Hood Canal www.regulations.gov) or by fax, mail or behalf of an association, business, labor make this a particularly difficult task as hand delivery, but please use only one union, etc.). You may review a Privacy it forces the submarines and their Coast of these means. If you submit a Guard security escorts to frequently Act notice regarding our public dockets comment online via http:// come into close quarters contact with in the January 17, 2008, issue of the www.regulations.gov, it will be the maritime public. Federal Register (73 FR 3316). considered received by the Coast Guard The RNA established by this rule will when you successfully transmit the Public Meeting allow Coast Guard security escort comment. If you fax, hand deliver, or personnel to order and/or direct persons mail your comment, it will be We do not now plan to hold a public and vessels operating within the RNA to considered as having been received by meeting. But you may submit a request stop, move, change orientation, etc. The the Coast Guard when it is received at for one on or before February 12, 2010 ability to do so will help avoid the Docket Management Facility. We using one of the four methods specified unnecessary and potentially dangerous recommend that you include your name under ADDRESSES. Please explain why close quarters contact between Coast and a mailing address, an e-mail you believe a public meeting would be Guard security escorts and the maritime address, or a telephone number in the beneficial. If we determine that one public within the Hood Canal. In body of your document so that we can would aid this rulemaking, we will hold addition, it will give Coast Guard contact you if we have questions one at a time and place announced by security escorts an additional tool for regarding your submission. a later notice in the Federal Register. determining the intent of vessels that,

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for whatever reason, are operating too vessels intending to transit the RNA Unfunded Mandates Reform Act close to an escorted submarine. Both of when it is in effect. The RNA will not, The Unfunded Mandates Reform Act these effects will help ensure the safety however, have a significant economic of 1995 (2 U.S.C. 1531–1538) requires and security of the submarines, their impact on a substantial number of small Federal agencies to assess the effects of Coast Guard security escorts, and the entities because (1) the RNA is only in their discretionary regulatory actions. In maritime public in general. effect for the short periods of time when particular, the Act addresses actions submarines are operating in Hood Canal Discussion of Rule that may result in the expenditure by a and being escorted by the Coast Guard State, local, or Tribal government, in the This rule establishes an RNA covering and (2) vessels may freely operate aggregate, or by the private sector of the Hood Canal in Washington that will within the RNA to the extent permitted $100,000,000 or more in any one year. be in effect whenever any U.S. Navy by other law or regulation unless given Though this rule will not result in such submarine is operating in the Hood a lawful order and/or direction by Coast an expenditure, we do discuss the Canal and being escorted by the Coast Guard security escort personnel. effects of this rule elsewhere in this Guard. All persons and vessels located If you think that your business, preamble. within the RNA are required to follow organization, or governmental all lawful orders and/or directions given Taking of Private Property jurisdiction qualifies as a small entity to them by Coast Guard security escort and that this rule would have a This rule will not effect a taking of personnel. significant economic impact on it, private property or otherwise have Regulatory Analyses please submit a comment (see taking implications under Executive Order 12630, Governmental Actions and We developed this interim rule after ADDRESSES) explaining why you think it qualifies and how and to what degree Interference with Constitutionally considering numerous statutes and Protected Property Rights. executive orders related to rulemaking. this rule would economically affect it. Below we summarize our analyses Assistance for Small Entities Civil Justice Reform based on 13 of these statutes or This rule meets applicable standards executive orders. Under section 213(a) of the Small in sections 3(a) and 3(b)(2) of Executive Business Regulatory Enforcement Regulatory Planning and Review Order 12988, Civil Justice Reform, to Fairness Act of 1996 (Pub. L. 104–121), minimize litigation, eliminate This rule is not a significant we offer to assist small entities in ambiguity, and reduce burden. regulatory action under section 3(f) of understanding the rule so that they can Executive Order 12866, Regulatory better evaluate its effects on them and Protection of Children Planning and Review, and does not participate in the rulemaking process. We have analyzed this rule under require an assessment of potential costs Small businesses may send comments Executive Order 13045, Protection of and benefits under section 6(a)(3) of that on the actions of Federal employees Children from Environmental Health Order. The Office of Management and who enforce, or otherwise determine Risks and Safety Risks. This rule is not Budget has not reviewed it under that compliance with, Federal regulations to an economically significant rule and Order. the Small Business and Agriculture does not create an environmental risk to The Coast Guard has made this Regulatory Enforcement Ombudsman health or risk to safety that may determination based on the fact that (1) and the Regional Small Business disproportionately affect children. the RNA is only in effect for the short Regulatory Fairness Boards. The Indian Tribal Governments periods of time when submarines are Ombudsman evaluates these actions operating in Hood Canal and being annually and rates each agency’s This rule does not have Tribal escorted by the Coast Guard and (2) responsiveness to small business. If you implications under Executive Order vessels may freely operate within the wish to comment on actions by 13175, Consultation and Coordination RNA to the extent permitted by other employees of the Coast Guard, call with Indian Tribal Governments, law or regulation unless given a lawful 1–888–REG–FAIR (1–888–734–3247). because it does not have a substantial order and/or direction by Coast Guard The Coast Guard will not retaliate direct effect on one or more Indian security escort personnel. against small entities that question or Tribes, on the relationship between the Federal Government and Indian Tribes, Small Entities complain about this rule or any policy or action of the Coast Guard. or on the distribution of power and Under the Regulatory Flexibility Act responsibilities between the Federal (5 U.S.C. 601–612), we have considered Collection of Information Government and Indian Tribes. whether this rule would have a significant economic impact on a This rule calls for no new collection Energy Effects substantial number of small entities. of information under the Paperwork We have analyzed this rule under The term ‘‘small entities’’ comprises Reduction Act of 1995 (44 U.S.C. 3501– Executive Order 13211, Actions small businesses, not-for-profit 3520). Concerning Regulations That organizations that are independently Federalism Significantly Affect Energy Supply, owned and operated and are not Distribution, or Use. We have dominant in their fields, and A rule has implications for federalism determined that it is not a ‘‘significant governmental jurisdictions with under Executive Order 13132, energy action’’ under that order because populations of less than 50,000. Federalism, if it has a substantial direct it is not a ‘‘significant regulatory action’’ The Coast Guard certifies under 5 effect on State or local governments and under Executive Order 12866 and is not U.S.C. 605(b) that this rule will not have would either preempt State law or likely to have a significant adverse effect a significant economic impact on a impose a substantial direct cost of on the supply, distribution, or use of substantial number of small entities. compliance on them. We have analyzed energy. The Administrator of the Office This rule will affect the following this rule under that Order and have of Information and Regulatory Affairs entities, some of which may be small determined that it does not have has not designated it as a significant entities: The owners or operators of implications for federalism. energy action. Therefore, it does not

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require a Statement of Energy Effects § 165.1328 Regulated Navigation Area; DATES: This rule is effective January 13, under Executive Order 13211. U.S. Navy Submarines, Hood Canal, 2010. Comments and related material Washington. must reach the Coast Guard on or before Technical Standards (a) Location. The following area is a April 13, 2010. Requests for public The National Technology Transfer regulated navigation area (RNA): All meetings must be received by the Coast and Advancement Act (NTTAA) (15 waters of the Hood Canal in Washington Guard on or before February 12, 2010. U.S.C. 272 note) directs agencies to use whenever any U.S. Navy submarine is ADDRESSES: You may submit comments voluntary consensus standards in their operating in the Hood Canal and being identified by docket number USCG– regulatory activities unless the agency escorted by the Coast Guard. 2009–1057 using any one of the provides Congress, through the Office of (b) Regulations. All persons and following methods: Management and Budget, with an vessels located within the RNA created (1) Federal eRulemaking Portal: explanation of why using these by paragraph (a) shall follow all lawful http://www.regulations.gov. standards would be inconsistent with orders and/or directions given to them (2) Fax: 202–493–2251. applicable law or otherwise impractical. by Coast Guard security escort (3) Mail: Docket Management Facility Voluntary consensus standards are personnel. 33 CFR Section 165, Subpart (M–30), U.S. Department of technical standards (e.g., specifications B, contains additional provisions Transportation, West Building Ground of materials, performance, design, or applicable to the RNA created in Floor, Room W12–140, 1200 New Jersey operation; test methods; sampling paragraph (a). Avenue, SE., Washington, DC 20590– procedures; and related management (c) Notification. The Coast Guard 0001. systems practices) that are developed or security escort will attempt, when (4) Hand delivery: Same as mail adopted by voluntary consensus necessary and practicable, to notify any address above, between 9 a.m. and 5 standards bodies. This rule does not use persons or vessels in the RNA created in p.m., Monday through Friday, except technical standards. Therefore, we did paragraph (a) of its existence via VHF Federal holidays. The telephone number not consider the use of voluntary Channel 16 and/or any other means is 202–366–9329. consensus standards. reasonably available. To avoid duplication, please use only Environment Dated: December 16, 2009. one of these four methods. See the G.T. Blore, ‘‘Public Participation and Request for We have analyzed this rule under Comments’’ portion of the Department of Homeland Security Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard District. SUPPLEMENTARY INFORMATION section Management Directive 023–01 and below for instructions on submitting [FR Doc. 2010–433 Filed 1–12–10; 8:45 am] Commandant Instruction M16475.lD, comments. which guide the Coast Guard in BILLING CODE 9110–04–P complying with the National FOR FURTHER INFORMATION CONTACT: If Environmental Policy Act of 1969 you have questions on this interim rule, (NEPA) (42 U.S.C. 4321–4370f), and DEPARTMENT OF HOMELAND call or e-mail LT Matthew N. Jones, Staff have concluded this action is one of a SECURITY Attorney, Thirteenth Coast Guard District; telephone 206–220–7155, e- category of actions which do not Coast Guard individually or cumulatively have a mail [email protected]. If you have questions on viewing or submitting significant effect on the human 33 CFR Part 165 environment. This rule is categorically material to the docket, call Renee V. Wright, Program Manager, Docket excluded, under figure 2–1, paragraph [Docket No. USCG–2009–1057] (34)(g), of the Instruction. This rule Operations, telephone 202–366–9826. involves the establishment of a RIN 1625–AA87 SUPPLEMENTARY INFORMATION: regulated navigation area. An Public Participation and Request for environmental analysis checklist and a Security Zone; Escorted U.S. Navy Comments categorical exclusion determination are Submarines in Sector Seattle Captain available in the docket where indicated of the Port Zone We encourage you to participate in under ADDRESSES. this rulemaking by submitting AGENCY: Coast Guard, DHS. comments and related materials. All List of Subjects in 33 CFR Part 165 ACTION: Interim rule with request for comments received will be posted, Harbors, Marine safety, Navigation comments. without change, to http:// (water), Reporting and recordkeeping www.regulations.gov and will include requirements, Security measures, SUMMARY: The Coast Guard is any personal information you have Waterways. establishing a moving security zone provided. ■ around any U.S. Navy submarine that is For the reasons discussed in the operating in the Sector Seattle Captain Submitting Comments preamble, the Coast Guard amends 33 of the Port Zone, which includes the If you submit a comment, please CFR part 165 as follows: Puget Sound and coastal waters of the include the docket number for this PART 165—REGULATED NAVIGATION State of Washington, and is being rulemaking (USCG–2009–1057), AREAS AND LIMITED ACCESS AREAS escorted by the Coast Guard. The indicate the specific section of this security zone is necessary to help document to which each comment ■ 1. The authority citation for part 165 ensure the security of the submarines, applies, and provide a reason for each continues to read as follows: their Coast Guard security escorts, and suggestion or recommendation. You Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. the maritime public in general. The may submit your comments and Chapter 701; 50 U.S.C. 191, 195; 33 CFR security zone will do so by prohibiting material online (via http:// 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 107– all persons and vessels from coming www.regulations.gov) or by fax, mail or 295, 116 Stat. 2064; Department of Homeland within 1,000 yards of an escorted hand delivery, but please use only one Security Delegation No. 0170.1. submarine unless authorized by the of these means. If you submit a ■ 2. Add § 165.1328 to read as follows: Coast Guard patrol commander. comment online via http://

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www.regulations.gov, it will be Public Meeting quick judgments about the intent of considered received by the Coast Guard We do not now plan to hold a public vessels operating in close proximity to when you successfully transmit the meeting. But you may submit a request the submarines and decide, occasionally comment. If you fax, hand deliver, or for one on or before February 12, 2010 with little information about the vessels mail your comment, it will be using one of the four methods specified or persons on board, whether or not they pose a threat to the submarine. considered as having been received by under ADDRESSES. Please explain why The security zone established by this the Coast Guard when it is received at you believe a public meeting would be rule will keep persons and vessels a the Docket Management Facility. We beneficial. If we determine that one sufficient distance away from recommend that you include your name would aid this rulemaking, we will hold submarines operating in and around the and a mailing address, an e-mail one at a time and place announced by Puget Sound and coastal waters of address, or a telephone number in the a later notice in the Federal Register. body of your document so that we can Washington so as to (1) avoid contact you if we have questions Regulatory Information unnecessary and potentially dangerous regarding your submission. The Coast Guard is issuing this contact with or distraction of Coast To submit your comment online, go to interim rule without prior notice and Guard security escorts and (2) give Coast http://www.regulations.gov, click on the opportunity to comment pursuant to Guard security escorts additional time ‘‘submit a comment’’ box, which will authority under section 4(a) of the and space to determine the intent of then become highlighted in blue. In the Administrative Procedure Act (APA) vessels that, for whatever reason, are ‘‘Document Type’’ drop down menu (5 U.S.C. 553(b)). This provision operating too close to a submarine. Both select ‘‘Proposed Rule’’ and insert authorizes an agency to issue a rule of these effects will help ensure the ‘‘USCG–2009–1057’’ in the ‘‘Keyword’’ without prior notice and opportunity to security of the submarines, their Coast box. Click ‘‘Search,’’ then click on the comment when the agency for good Guard security escorts, and the maritime balloon shape in the ‘‘Actions’’ column. cause finds that those procedures are public in general. If you submit comments by mail or hand ‘‘impracticable, unnecessary, or contrary Discussion of Rule delivery, submit them in an unbound to the public interest.’’ Under 5 U.S.C. This rule establishes a moving format, no larger than 81⁄2 by 11 inches, 553(b)(B), the Coast Guard finds that security zone encompassing all waters suitable for copying and electronic good cause exists for not publishing a within 1,000 yards of any U.S. Navy filing. If you submit comments by mail notice of proposed rulemaking (NPRM) submarine that is operating in the Sector and would like to know that they with respect to this rule because Seattle Captain of the Port Zone as reached the Facility, please enclose a publishing an NPRM would be contrary defined in 33 CFR 3.65–10, which stamped, self-addressed postcard or to the public interest since U.S. Navy includes the Puget Sound and coastal envelope. We will consider all submarine operations in the Sector waters of the State of Washington, and comments and material received during Seattle Captain of the Port Zone are is being escorted by the Coast Guard. All the comment period and may change ongoing, making the security zone persons and vessels are prohibited from this rule based on your comments. created by this rule immediately entering the security zone unless Viewing Comments and Documents necessary to help ensure the security of authorized by the Coast Guard patrol the submarines, their Coast Guard commander. While naval vessel To view comments, as well as security escorts, and the maritime protection zones, under 33 CFR documents mentioned in this preamble public in general. 165.2030, around these escorted U.S. as being available in the docket, go to Under 5 U.S.C. 553(d)(3), the Coast Navy submarines are still in effect, http://www.regulations.gov, click on the Guard finds that good cause exists for persons would need to seek permission ‘‘read comments’’ box, which will then making this rule effective less than 30 from the Coast Guard patrol commander become highlighted in blue. In the days after publication in the Federal to enter within 1,000 yards of these ‘‘Keyword’’ box insert ‘‘USCG–2009– Register because waiting 30 days would escorted submarines while they are in 1057’’ and click ‘‘Search.’’ Click the be contrary to the public interest since the Sector Seattle Captain of the Port ‘‘Open Docket Folder’’ in the ‘‘Actions’’ U.S. Navy submarine operations in the Zone. column. You may also visit the Docket Sector Seattle Captain of the Port Zone Management Facility in Room W12–140 are ongoing, making the security zone Regulatory Analyses on the ground floor of the Department created by this rule immediately We developed this interim rule after of Transportation West Building, 1200 necessary to help ensure the security of considering numerous statutes and New Jersey Avenue, SE., Washington, the submarines, their Coast Guard executive orders related to rulemaking. DC 20590, between 9 a.m. and 5 p.m., security escorts, and the maritime Below we summarize our analyses Monday through Friday, except Federal public in general. based on 13 of these statutes or holidays. We have an agreement with executive orders. the Department of Transportation to use Background and Purpose the Docket Management Facility. U.S. Navy submarines frequently Regulatory Planning and Review operate in the Sector Seattle Captain of Privacy Act This rule is not a significant the Port Zone as defined in 33 CFR regulatory action under section 3(f) of Anyone can search the electronic 3.65–10, which includes the Puget Executive Order 12866, Regulatory form of comments received into any of Sound and coastal waters of the State of Planning and Review, and does not our dockets by the name of the Washington. Due to the numerous require an assessment of potential costs individual submitting the comment (or security concerns involved with and benefits under section 6(a)(3) of that signing the comment, if submitted on submarine operations near shore, the Order. The Office of Management and behalf of an association, business, labor Coast Guard frequently provides Budget has not reviewed it under that union, etc.). You may review a Privacy security escorts of submarines when Order. Act notice regarding our public dockets operating in those areas. Security The Coast Guard has made this in the January 17, 2008, issue of the escorts of this type require the Coast determination based on the fact that (1) Federal Register (73 FR 3316). Guard personnel on-scene to make the security zone is only in effect for the

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short periods of time when submarines understanding the rule so that they can Protection of Children are operating in and around the Puget better evaluate its effects on them and We have analyzed this rule under Sound and other coastal waters of participate in the rulemaking process. Executive Order 13045, Protection of Washington and being escorted by the Small businesses may send comments Children from Environmental Health Coast Guard, (2) the security zone on the actions of Federal employees Risks and Safety Risks. This rule is not moves with the submarines, (3) vessels who enforce, or otherwise determine an economically significant rule and will be able to transit around the compliance with, Federal regulations to does not create an environmental risk to security zone at most locations in the the Small Business and Agriculture health or risk to safety that may Puget Sound and other coastal waters of Regulatory Enforcement Ombudsman disproportionately affect children. Washington, and (4) vessels may, if and the Regional Small Business necessary, be authorized to enter the Regulatory Fairness Boards. The Indian Tribal Governments security zone with the permission of the Ombudsman evaluates these actions This rule does not have tribal Coast Guard patrol commander. annually and rates each agency’s implications under Executive Order Small Entities responsiveness to small business. If you 13175, Consultation and Coordination wish to comment on actions by with Indian Tribal Governments, Under the Regulatory Flexibility Act employees of the Coast Guard, call because it does not have a substantial (5 U.S.C. 601–612), we have considered 1–888–REG–FAIR (1–888–734–3247). direct effect on one or more Indian whether this rule would have a The Coast Guard will not retaliate tribes, on the relationship between the significant economic impact on a against small entities that question or Federal Government and Indian tribes, substantial number of small entities. complain about this rule or any policy or on the distribution of power and The term ‘‘small entities’’ comprises or action of the Coast Guard. responsibilities between the Federal small businesses, not-for-profit Government and Indian tribes. organizations that are independently Collection of Information owned and operated and are not This rule calls for no new collection Energy Effects dominant in their fields, and of information under the Paperwork We have analyzed this rule under governmental jurisdictions with Reduction Act of 1995 (44 U.S.C. 3501– Executive Order 13211, Actions populations of less than 50,000. 3520). Concerning Regulations That The Coast Guard certifies under 5 Significantly Affect Energy Supply, U.S.C. 605(b) that this rule will not have Federalism Distribution, or Use. We have a significant economic impact on a A rule has implications for federalism determined that it is not a ‘‘significant substantial number of small entities. under Executive Order 13132, energy action’’ under that order because This rule will affect the following Federalism, if it has a substantial direct it is not a ‘‘significant regulatory action’’ entities, some of which may be small effect on State or local governments and under Executive Order 12866 and is not entities: The owners or operators of would either preempt State law or likely to have a significant adverse effect vessels intending to transit an area impose a substantial direct cost of on the supply, distribution, or use of covered by the security zone. The compliance on them. We have analyzed energy. The Administrator of the Office security zone will not, however, have a this rule under that Order and have of Information and Regulatory Affairs significant economic impact on a determined that it does not have has not designated it as a significant substantial number of small entities implications for federalism. energy action. Therefore, it does not because (1) the security zone is only in require a Statement of Energy Effects Unfunded Mandates Reform Act effect for the short periods of time when under Executive Order 13211. submarines are operating in and around The Unfunded Mandates Reform Act the Puget Sound and other coastal of 1995 (2 U.S.C. 1531–1538) requires Technical Standards waters of Washington and being Federal agencies to assess the effects of The National Technology Transfer escorted by the Coast Guard, (2) the their discretionary regulatory actions. In and Advancement Act (NTTAA) (15 security zone moves with the particular, the Act addresses actions U.S.C. 272 note) directs agencies to use submarines, (3) vessels will be able to that may result in the expenditure by a voluntary consensus standards in their transit around the security zone at most State, local, or tribal government, in the regulatory activities unless the agency locations in the Puget Sound and other aggregate, or by the private sector of provides Congress, through the Office of coastal waters of Washington, and (4) $100,000,000 or more in any one year. Management and Budget, with an vessels may, if necessary, be authorized Though this rule will not result in such explanation of why using these to enter the security zone with the an expenditure, we do discuss the standards would be inconsistent with permission of the Coast Guard patrol effects of this rule elsewhere in this applicable law or otherwise impractical. commander. preamble. Voluntary consensus standards are If you think that your business, technical standards (e.g., specifications Taking of Private Property organization, or governmental of materials, performance, design, or jurisdiction qualifies as a small entity This rule will not effect a taking of operation; test methods; sampling and that this rule would have a private property or otherwise have procedures; and related management significant economic impact on it, taking implications under Executive systems practices) that are developed or please submit a comment (see Order 12630, Governmental Actions and adopted by voluntary consensus ADDRESSES) explaining why you think it Interference with Constitutionally standards bodies. qualifies and how and to what degree Protected Property Rights. This rule does not use technical standards. Therefore, we did not this rule would economically affect it. Civil Justice Reform consider the use of voluntary consensus Assistance for Small Entities This rule meets applicable standards standards. Under section 213(a) of the Small in sections 3(a) and 3(b)(2) of Executive Business Regulatory Enforcement Order 12988, Civil Justice Reform, to Environment Fairness Act of 1996 (Pub. L. 104–121), minimize litigation, eliminate We have analyzed this rule under we offer to assist small entities in ambiguity, and reduce burden. Department of Homeland Security

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Management Directive 023–01 and Dated: December 16, 2009. extensive, containing such elements as Commandant Instruction M16475.lD, G.T. Blore, air pollution control regulations, which guide the Coast Guard in Rear Admiral, U.S. Coast Guard, Commander, emission inventories, monitoring complying with the National Thirteenth Coast Guard District. networks, attainment demonstrations, Environmental Policy Act of 1969 [FR Doc. 2010–438 Filed 1–12–10; 8:45 am] and enforcement mechanisms. (NEPA) (42 U.S.C. 4321–4370f), and BILLING CODE 9110–04–P Each state must formally adopt the have concluded this action is one of a control measures and strategies in the category of actions which do not SIP after the public has had an individually or cumulatively have a ENVIRONMENTAL PROTECTION opportunity to comment on them and significant effect on the human AGENCY then submit the SIP to EPA. Once these environment. This rule is categorically control measures and strategies are excluded, under figure 2–1, paragraph 40 CFR Part 52 approved by EPA, after notice and (34)(g), of the Instruction. This rule comment, they are incorporated into the involves the establishment of a security [MS–200923; FRL–9088–6] federally approved SIP and are identified in part 52 ‘‘Approval and zone. An environmental analysis Approval and Promulgation of Air Promulgation of Implementation Plans,’’ checklist and a categorical exclusion Quality Implementation Plans; Title 40 of the Code of Federal determination are available in the Mississippi; Update to Materials docket where indicated under Regulations (40 CFR part 52). The full Incorporated by Reference ADDRESSES. text of the state regulation approved by AGENCY: EPA is not reproduced in its entirety in List of Subjects in 33 CFR Part 165 Environmental Protection Agency (EPA). 40 CFR part 52, but is ‘‘incorporated by Harbors, Marine safety, Navigation ACTION: Final rule; administrative reference.’’ This means that EPA has (water), Reporting and recordkeeping change. approved a given state regulation with requirements, Security measures, a specific effective date. The public is Waterways. SUMMARY: EPA is publishing this action referred to the location of the full text ■ For the reasons discussed in the to provide the public with notice of the version should they want to know preamble, the Coast Guard amends 33 update to the Mississippi State which measures are contained in a CFR part 165 as follows: Implementation Plan (SIP) compilation. given SIP. The information provided In particular, materials submitted by allows EPA and the public to monitor PART 165—REGULATED NAVIGATION Mississippi that are incorporated by the extent to which a state implements AREAS AND LIMITED ACCESS AREAS reference (IBR) into the Mississippi SIP a SIP to attain and maintain the NAAQS are being updated to reflect EPA- and to take enforcement action if ■ 1. The authority citation for part 165 approved revisions to Mississippi’s SIP necessary. continues to read as follows: that have occurred since the last update. The SIP is a living document which Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. In this action, EPA is also notifying the the state can revise as necessary to Chapter 701; 50 U.S.C. 191, 195; 33 CFR public of the correction of certain address the unique air pollution 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 107– typographical errors. problems in the state. Therefore, EPA 295, 116 Stat. 2064; Department of Homeland from time to time must take action on Security Delegation No. 0170.1. DATES: This action is effective January SIP revisions containing new and/or ■ 13, 2010. 2. Add § 165.1327 to read as follows: revised regulations as being part of the ADDRESSES: SIP materials which are SIP. On May 22, 1997, (62 FR 27968), § 165.1327 Security Zone; Escorted U.S. incorporated by reference into 40 CFR EPA revised the procedures for Navy Submarines in Sector Seattle Captain part 52 are available for inspection at of the Port Zone. incorporating by reference, into the the following locations: Environmental CFR, materials submitted by states in (a) Location. The following area is a Protection Agency, Region 4, 61 Forsyth their EPA-approved SIP revisions. These security zone: All waters within 1,000 Street, SW., Atlanta, GA 30303; the Air changes revised the format for the yards of any U.S. Navy submarine that and Radiation Docket and Information identification of the SIP in 40 CFR part is operating in the Sector Seattle Center, EPA Headquarters Library, 52, stream-lined the mechanisms for Captain of the Port Zone, as defined in Infoterra Room (Room Number 3334), 33 CFR 3.65–10, and that is being announcing EPA approval of revisions EPA West Building, 1301 Constitution to a SIP, and stream-lined the escorted by the Coast Guard. Ave., NW., Washington, DC 20460, and (b) Regulations. In accordance with mechanisms for EPA’s updating of the the National Archives and Records the general regulations in 33 CFR part IBR information contained for each SIP Administration. If you wish to obtain 165, subpart D, no person or vessel may in 40 CFR part 52. The revised materials from a docket in the EPA enter or remain in the security zone procedures also called for EPA to Headquarters Library, please call the created by paragraph (a) of this section maintain ‘‘SIP Compilations’’ that Office of Air and Radiation (OAR) unless authorized by the Coast Guard contain the federally-approved Docket/Telephone number: (202) 566– patrol commander. 33 CFR part 165, regulations and source specific permits subpart D, contains additional 1742. For information on the availability submitted by each state agency. These provisions applicable to the security of this material at NARA, call 202–741– SIP Compilations are contained in 3- zone created in paragraph (a) of this 6030, or go to: http://www.archives.gov/ ring binders and are updated primarily section. federal-register/cfr/ibr-locations.html. on an annual basis. Under the revised (c) Notification. The Coast Guard FOR FURTHER INFORMATION CONTACT: Ms. procedures, EPA is to periodically security escort will attempt, when Twunjala Bradley at the above Region 4 publish an informational document in necessary and practicable, to notify any address or at (404) 562–9352. the rules section of the Federal Register persons or vessels inside or in the SUPPLEMENTARY INFORMATION: Each state when updates are made to a SIP vicinity of the security zone created in has a SIP containing the control Compilation for a particular state. EPA’s paragraph (a) of this section of its measures and strategies used to attain 1997 revised procedures were formally existence via VHF Channel 16 and/or and maintain the national ambient air applied to Mississippi on July 1, 1997 any other means reasonably available. quality standards (NAAQS). The SIP is (62 FR 35441).

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This action represents EPA’s administrative action is not a B. Submission to Congress and the publication of the Mississippi SIP ‘‘significant regulatory action’’ and is Comptroller General Compilation update, appearing in 40 therefore not subject to review by the The Congressional Review Act (CRA) CFR part 52. In addition, notice is Office of Management and Budget. This (5 U.S.C. 801 et seq.), as added by the provided of the following typographical action is not subject to Executive Order Small Business Regulatory Enforcement corrections to Table (c) of paragraph 13211, ‘‘Actions Concerning Regulations Fairness Act of 1996, generally provides 52.1270, as described below: That Significantly Affect Energy Supply, that before a rule may take effect, the 1. Correcting typographical errors listed in Distribution, or Use’’ (66 FR 28355, May agency promulgating the rule must Table 1 of paragraph 52.127(c), as described 22, 2001) because it is not a significant submit a rule report, which includes a below: regulatory action under Executive Order copy of the rule, to each House of the A. State Citation APC–S–1 Section 6 State 12866. Because the Agency has made a Congress and to the Comptroller General Effective Date is revised to read ‘‘5/28/99.’’ ‘‘good cause’’ finding that this action is of the United States. Section 808 allows B. State Citation APC–S–2 Sections I thru the issuing agency to make a rule XVII EPA Approval Date and Citation is not subject to notice-and-comment requirements under the APA or any effective sooner than otherwise revised to read ‘‘7/10/06, 71 FR 38773’’ provided by the CRA if the agency respectively. other statute as indicated in the makes a good cause finding that notice C. State Citation APC–S–2 Section I State Supplementary Information section and public procedure is impracticable, Effective Date is revised to read ‘‘8/27/05.’’ above, it is not subject to the regulatory unnecessary or contrary to the public D. State Citation APC–S–2 Section XVI EPA flexibility provisions of the Regulatory interest. Today’s administrative action Approval Date Citation is revised to read Flexibility Act (5 U.S.C 601 et seq.), or ‘‘71 FR 38773.’’ simply codifies (and corrects) E. State Citation APC–S–2 is revised to read, to sections 202 and 205 of the Unfunded provisions which are already in effect as ‘‘Section I.’’ Mandates Reform Act (UMRA) of 1995 a matter of law in Federal and approved F. State Citation APC–S–3 Section 2 is (Pub. L. 104–4). In addition, this action State programs. 5 U.S.C. 808(2). These revised to read ‘‘2/4/72.’’ does not significantly or uniquely affect announced actions were effective when 2. Revising the date format listed in small governments or impose a EPA approved them through previous paragraphs 52.1270(c). Revise the date format significant intergovernmental mandate, rulemaking actions. EPA will submit a in the ‘‘State effective date,’’ and ‘‘EPA as described in sections 203 and 204 of report containing this action and other ’’ approval date, columns for consistency. UMRA. This administrative action also required information to the U.S. Senate, Dates are numerical month/day/year without additional zeros. does not have a substantial direct effect the U.S. House of Representatives, and on one or more Indian tribes, on the the Comptroller General of the United EPA has determined that today’s relationship between the Federal States prior to publication of this action action falls under the ‘‘good cause’’ Government and Indian tribes, or on the in the Federal Register. This update to exemption in the section 553(b)(3)(B) of distribution of power and Mississippi’s SIP Compilation and the Administrative Procedure Act (APA) responsibilities between the Federal correction of typographical errors is not ‘‘ ’’ which, upon finding good cause, Government and Indian tribes, as a ‘‘major rule’’ as defined by 5 U.S.C. authorizes agencies to dispense with specified by Executive Order 13175 (65 804(2). public participation and section FR 67249, November 9, 2000), nor will 553(d)(3) which allows an agency to C. Petitions for Judicial Review it have substantial direct effects on the make an action effective immediately EPA has also determined that the (thereby avoiding the 30-day delayed States, on the relationship between the provisions of section 307(b)(1) of the effective date otherwise provided for in national government and the States, or Clean Air Act pertaining to petitions for the APA). Today’s administrative action on the distribution of power and judicial review are not applicable to this simply codifies provisions which are responsibilities among the various action. This action is simply an already in effect as a matter of law in levels of government, as specified in announcement of prior rulemakings that Federal and approved state programs Executive Order 13132 (64 FR 43255, have previously undergone notice and and corrects typographical errors August 10, 1999). This administrative comment rulemaking. Prior EPA appearing the Federal Register. Under action also is not subject to Executive rulemaking actions for each individual section 553 of the APA, an agency may Order 13045 (62 FR 19885, April 23, component of the Mississippi SIP find good cause where procedures are 1997), because it is not economically compilation previously afforded ‘‘impractical, unnecessary, or contrary to significant. This administrative action interested parties the opportunity to file the public interest.’’ Public comment for does not involve technical standards; a petition for judicial review in the this administrative action is thus the requirements of section 12(d) of United States Court of Appeals for the ‘‘unnecessary’’ and ‘‘contrary to the the National Technology Transfer and appropriate circuit within 60 days of public interest’’ since the codification Advancement Act of 1995 (15 U.S.C. such rulemaking action. (and typographical corrections) only 272 note) do not apply. The List of Subjects in 40 CFR Part 52 reflect existing law. Immediate notice of administrative action also does not this action in the Federal Register involve special consideration of Environmental protection, Air benefits the public by providing the environmental justice related issues as pollution control, Carbon monoxide, public notice of the updated Mississippi required by Executive Order 12898 (59 Incorporation by reference, SIP Compilation and notice of FR 7629, February 16, 1994). This Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate typographical corrections to the administrative action does not impose matter, Reporting and recordkeeping Mississippi ‘‘Identification of Plan’’ an information collection burden under requirements, Sulfur oxides, Volatile portion of the Federal Register. the Paperwork Reduction Act of 1995 organic compounds. Statutory and Executive Order Reviews (44 U.S.C. 3501 et seq.). EPA’s compliance with these Statutes and Dated: November 6, 2009. A. General Requirements Executive Orders for the underlying Beverly H. Banister, Under Executive Order 12866 (58 FR rules are discussed in previous actions Acting Regional Administrator, Region 4. 51735, October 4, 1993), this taken on the State’s rules. ■ 40 CFR part 52 is amended as follows:

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PART 52—[AMENDED] incorporated as it exists on the date of inspected at the Region 4 EPA Office at the approval, and notice of any change 61 Forsyth Street, SW., Atlanta, GA ■ 1. The authority citation for part 52 in the material will be published in the 30303, the Air and Radiation Docket continues to read as follows: Federal Register. Entries in paragraphs and Information Center, EPA Authority: 42 U.S.C. 7401 et seq. (c) and (d) of this section with EPA Headquarters Library, Infoterra Room approval dates after October 3, 2007, for (Room Number 3334), EPA West Subpart Z—Mississippi Mississippi will be incorporated by Building, 1301 Constitution Ave., NW., reference in the next update to the SIP Washington, DC 20460, and the ■ 2. Section 52.1270 paragraphs (b) and compilation. National Archives and Records (c) are revised to read as follows: (2) EPA Region 4 certifies that the Administration. If you wish to obtain § 52.1270 Identification of plan. rules/regulations provided by EPA in materials from a docket in the EPA * * * * * the SIP compilation at the addresses in Headquarters Library, please call the (b) Incorporation by reference. paragraph (b)(3) of this section are an Office of Air and Radiation (OAR) (1) Material listed in paragraph (c) of exact duplicate of the officially Docket/Telephone number: (202) 566– this section with an EPA approval date promulgated State rules/regulations 1742. For information on the availability prior to October 3, 2007, for Mississippi which have been approved as part of the of this material at NARA, call 202–741– was approved for incorporation by State Implementation Plan as of the 6030, or go to: http://www.archives.gov/ reference by the Director of the Federal dates referenced in paragraph (b)(1). federal-register/cfr/ibr-locations.html. Register in accordance with 5 U.S.C. (3) Copies of the materials (c) EPA Approved Mississippi 552(a) and 1 CFR part 51. Material is incorporated by reference may be Regulations.

EPA-APPROVED MISSISSIPPI REGULATIONS

State effective State citation Title/subject date EPA approval date Explanation

APC–S–1 Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants

Section 1 ...... General ...... 1/9/94 2/12/96, 61 FR 5295. Section 2 ...... Definitions ...... 1/9/94 2/12/96, 61 FR 5295. Section 3...... Specific Criteria for Sources of Particulate 5/28/99 12/20/02, 67 FR 77926. Matter. Section 4 ...... Specific Criteria for Sources of Sulfur Com- 1/9/94 2/12/96, 61 FR 5295. pounds. Section 5...... Specific Criteria for Sources of Chemical 1/9/94 2/12/96, 61 FR 5295. Emissions. Section 6 ...... New Sources ...... 5/28/99 12/20/02, 67 FR 77926 ...... Subsection 2, ‘‘Other Limitations,’’ and Subsection 3, ‘‘New Source Performance Standards,’’ are not federally approved. Section 7 ...... Exceptions ...... 2/4/72 5/31/72, 37 FR 10875. Section 9 ...... Stack Height Considerations...... 5/1/86 9/23/87, 52 FR 35704. Section 10...... Provisions for Upsets, Startups, and Shut- 1/9/94 2/12/96, 61 FR 5295. downs. Section 11 ...... Severability ...... 1/9/94 2/12/96, 61 FR 5295. Section 14 ...... Provision for the Clean Air Interstate Rule ...... 12/17/06 10/3/07, 72 FR 56268.

APC–S–2 Permit Regulations for the Construction and/or Operation of Air Emissions Equipment

Section I ...... General Requirements ...... 8/27/05 7/10/06, 71 FR 38773. Section II ...... General Standards Applicable to All Permits ... 8/27/05 7/10/06, 71 FR 38773. Section III ...... Application For Permit To Construct and State 8/27/05 7/10/06, 71 FR 38773. Permit To Operate New Stationary Source. Section IV ...... Public Participation and Public Availability of 8/27/05 7/10/06, 71 FR 38773. Information. Section V ...... Application Review ...... 8/27/05 7/10/06, 71 FR 38773. Section VI ...... Compliance Testing ...... 8/27/05 7/10/06, 71 FR 38773. Section VII ...... Emission Evaluation Report ...... 8/27/05 7/10/06, 71 FR 38773. Section VIII ...... Procedures for Renewal of State Permit To 8/27/05 7/10/06, 71 FR 38773. Operate. Section IX ...... Reporting and Record Keeping ...... 8/27/05 7/10/06, 71 FR 38773. Section X ...... Emission Reduction Schedule ...... 8/27/05 7/10/06, 71 FR 38773. Section XI ...... General Permits ...... 8/27/05 7/10/06, 71 FR 38773. Section XII ...... Multi-Media Permits ...... 8/27/05 7/10/06, 71 FR 38773. Section XIII ...... Exclusions ...... 8/27/05 7/10/06, 71 FR 38773. Section XIV ...... CAFO ...... 8/27/05 7/10/06, 71 FR 38773. Section XV ...... Options ...... 8/27/05 7/10/06, 71 FR 38773. Section XVI ...... Permit Transfer ...... 8/27/05 7/10/06, 71 FR 38773. Section XVII ...... Severability ...... 8/27/05 7/10/06, 71 FR 38773.

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EPA-APPROVED MISSISSIPPI REGULATIONS—Continued

State effective State citation Title/subject date EPA approval date Explanation

APC–S–3 Regulations for the Prevention of Air Pollution Emergency Episodes

Section 1 ...... General ...... 2/4/72 5/31/72, 37 FR 10875. Section 2 ...... Definitions ...... 2/4/72 5/31/72, 37 FR 10875. Section 3 ...... Episode Criteria ...... 6/3/88 11/13/89, 54 FR 47211. Section 4 ...... Emission Control Action Programs ...... 2/4/72 5/31/72, 37 FR 10875. Section 5 ...... Emergency Orders ...... 6/3/88 11/13/89, 54 FR 47211.

APC–S–5 Regulations for the Prevention of Significant Deterioration of Air Quality

All ...... 8/27/05 7/10/06, 71 FR 38773.

* * * * * State Implementation Plan (SIP). These some may not be publicly available in [FR Doc. 2010–348 Filed 1–12–10; 8:45 am] revisions were proposed in the Federal either location (e.g., CBI). To inspect the BILLING CODE 6560–50–P Register on August 14, 2009 and hard copy materials, please schedule an concern oxides of nitrogen (NOX) and appointment during normal business particulate matter (PM) emissions from hours with the contact listed in the FOR ENVIRONMENTAL PROTECTION boilers of various capacities. We are FURTHER INFORMATION CONTACT section. AGENCY approving local rules that regulate these FOR FURTHER INFORMATION CONTACT: emission sources under the Clean Air 40 CFR Part 52 Idalia Perez, EPA Region IX, (415) 972– Act as amended in 1990 (CAA or the 3248, [email protected]. [EPA–R09–OAR–2009–0474; FRL–9100–1] Act). SUPPLEMENTARY INFORMATION: DATES: Effective Date: This rule is Throughout this document, ‘‘we,’’ ‘‘us’’ Revisions to the California State effective on February 12, 2010. Implementation Plan, San Joaquin and ‘‘our’’ refer to EPA. ADDRESSES: EPA has established docket Valley Unified Air Pollution Control Table of Contents District number EPA–R09–OAR–2009–0474 for this action. The index to the docket is I. Proposed Action AGENCY: Environmental Protection available electronically at http:// II. Public Comments and EPA Responses Agency (EPA). www.regulations.gov and in hard copy III. EPA Action ACTION: Final rule. at EPA Region IX, 75 Hawthorne Street, IV. Statutory and Executive Order Reviews San Francisco, California. While all I. Proposed Action SUMMARY: EPA is finalizing approval of documents in the docket are listed in revisions to the San Joaquin Valley the index, some information may be On August 14, 2009 (74 FR 41104), Unified Air Pollution Control District publicly available only at the hard copy EPA proposed to approve the following (SJVAPCD) portion of the California location (e.g., copyrighted material), and rules into the California SIP.

Local agency Rule No. Rule title Adopted Submitted

SJVAPCD ...... 4306 Boilers, Steam Generators and Process Heaters— 10/16/08 03/17/09 Phase 3. SJVAPCD ...... 4307 Boilers, Steam Generators and Process Heaters—2.0 10/16/08 03/17/09 MMbtu/hr to 5.0 MMbtu/hr.

We proposed to approve these rules these provisions should be made when shut-down event exceeds the limitations because we determined that they the Rule is next revised. of the duration of such events in Section complied with the relevant CAA We have identified the possibility that 5.4.1 or 5.4.2. EPA recommends that requirements. Our proposed action some units that are subject to Rule 4307 Section 6.1.4 of Rule 4307 be revised to contains more information on the rules do not need exemptions from basic require records that specify the duration and our evaluation. emission limits during start-up and of all start-up and shut-down periods (at II. Public Comments and EPA shutdown periods as long as they are least for units located at Title V Responses maintained and operated appropriately. facilities). EPA notes that the limited For example, we believe that heater applicability of the current version of EPA’s proposed action provided a 30- treaters which rely only on low-NO 6.1.4 may not be appropriate in other day public comment period. During this X burners for compliance are capable of rules, particularly those where periodic period, we received no comments. consistent compliance with the Rule’s or continuous monitoring is required. III. EPA Action basic emission limits during these No comments were submitted that Since publication of the proposed periods. As a result, Section 5.4 should change our assessment that the action, we identified two minor issues be revised to remove the start-up and submitted rules comply with the regarding Rule 4307 that do not change shutdown exemption period for such relevant CAA requirements. Therefore, our assessment that the submitted rule devices. as authorized in section 110(k)(3) of the complies with the relevant CAA Currently Section 6.1.4 requires Act, EPA is fully approving these rules requirements. Nonetheless, revisions to recordkeeping only if the start-up and into the California SIP.

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IV. Statutory and Executive Order costs on Tribal governments or preempt (i) * * * Reviews Tribal law. (A) * * * The Congressional Review Act, 5 Under the Clean Air Act, the (3) Rule 4306, ‘‘Boilers, Steam U.S.C. 801 et seq., as added by the Small Administrator is required to approve a Generators and Process Heaters—Phase Business Regulatory Enforcement SIP submission that complies with the 3, ’’ adopted on October 16, 2008. Fairness Act of 1996, generally provides provisions of the Act and applicable (4) Rule 4307, ‘‘Boilers, Steam that before a rule may take effect, the Federal regulations. 42 U.S.C. 7410(k); Generators and Process Heaters—2.0 agency promulgating the rule must 40 CFR 52.02(a). Thus, in reviewing SIP MMbtu/hr to 5.0 MMbtu/hr,’’ adopted submit a rule report, which includes a submissions, EPA’s role is to approve on October 16, 2008. copy of the rule, to each House of the State choices, provided that they meet * * * * * Congress and to the Comptroller General the criteria of the Clean Air Act. [FR Doc. 2010–352 Filed 1–12–10; 8:45 am] of the United States. EPA will submit a Accordingly, this action merely BILLING CODE 6560–50–P report containing this action and other approves State law as meeting Federal required information to the U.S. Senate, requirements and does not impose the U.S. House of Representatives, and additional requirements beyond those ENVIRONMENTAL PROTECTION the Comptroller General of the United imposed by State law. For that reason, AGENCY States prior to publication of the rule in this action: • Is not a ‘‘significant regulatory the Federal Register. A major rule 40 CFR Part 52 action’’ subject to review by the Office cannot take effect until 60 days after it of Management and Budget under is published in the Federal Register. [EPA–R09–OAR–2009–0024; FRL–9097–2] ‘‘ ’’ Executive Order 12866 (58 FR 51735, This action is not a major rule as October 4, 1993); defined by 5 U.S.C. 804(2). Revisions to the California State Under section 307(b)(1) of the Clean • Does not impose an information Implementation Plan, San Joaquin Air Act, petitions for judicial review of collection burden under the provisions Valley Unified Air Pollution Control this action must be filed in the United of the Paperwork Reduction Act (44 District States Court of Appeals for the U.S.C. 3501 et seq.); appropriate circuit by March 15, 2010. AGENCY: Environmental Protection • Is certified as not having a Filing a petition for reconsideration by Agency (EPA). significant economic impact on a the Administrator of this final rule does substantial number of small entities ACTION: Final rule. not affect the finality of this action for under the Regulatory Flexibility Act (5 the purposes of judicial review nor does SUMMARY: EPA is finalizing a limited U.S.C. 601 et seq.); it extend the time within which a approval and limited disapproval of • Does not contain any unfunded petition for judicial review may be filed, revisions to the San Joaquin Valley mandate or significantly or uniquely and shall not postpone the effectiveness Unified Air Pollution Control District affect small governments, as described of such rule or action. This action may (SJVUAPCD) portion of the California in the Unfunded Mandates Reform Act not be challenged later in proceedings to State Implementation Plan (SIP). This of 1995 (Pub. L. 104–4); action was proposed in the Federal • Does not have Federalism enforce its requirements (see section 307(b)(2)). Register on August 19, 2009, and implications as specified in Executive concerns a local fee rule that applies to Order 13132 (64 FR 43255, August 10, List of Subjects in 40 CFR Part 52 major sources of volatile organic 1999); • Environmental protection, Air compound and nitrogen oxide Is not an economically significant pollution control, Incorporation by emissions in the San Joaquin Valley regulatory action based on health or reference, Intergovernmental relations, ozone nonattainment area. Under safety risks subject to Executive Order Nitrogen dioxide, Ozone, Particulate authority of the Clean Air Act as 13045 (62 FR 19885, April 23, 1997); matter, Reporting and recordkeeping amended in 1990 (CAA or the Act), this • Is not a significant regulatory action requirements. action simultaneously approves a local subject to Executive Order 13211 (66 FR rule that regulates these emission 28355, May 22, 2001); Dated: November 23, 2009. sources and directs California to correct • Is not subject to requirements of Laura Yoshii, rule deficiencies. Section 12(d) of the National Acting Regional Administrator, Region IX. DATES: Effective Date: This rule is Technology Transfer and Advancement ■ Part 52, Chapter I, Title 40 of the Code effective on February 12, 2010. Act of 1995 (15 U.S.C. 272 note) because of Federal Regulations is amended as application of those requirements would follows: ADDRESSES: EPA has established docket be inconsistent with the Clean Air Act; number EPA–R09–OAR–2009–0024 for and PART 52—[AMENDED] this action. The index to the docket is • Does not provide EPA with the available electronically at http:// discretionary authority to address, as ■ 1. The authority citation for Part 52 www.regulations.gov and in hard copy appropriate, disproportionate human continues to read as follows: at EPA Region IX, 75 Hawthorne Street, health or environmental effects, using Authority: 42 U.S.C. 7401 et seq. San Francisco, California. While all practicable and legally permissible documents in the docket are listed in methods, under Executive Order 12898 Subpart F—California the index, some information may be (59 FR 7629, February 16, 1994). ■ 2. Section 52.220, is amended by publicly available only at the hard copy In addition, these rules do not have adding paragraphs (c)(363)(i)(A)(3) and location (e.g., copyrighted material), and Tribal implications as specified by (4) to read as follows: some may not be publicly available in Executive Order 13175 (65 FR 67249, either location (e.g., CBI). To inspect the November 9, 2000), because the SIP is § 52.220 Identification of plan. hard copy materials, please schedule an not approved to apply in Indian country * * * * * appointment during normal business located in the State, and EPA notes that (c) * * * hours with the contact listed in the FOR it will not impose substantial direct (363) * * * FURTHER INFORMATION CONTACT section.

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FOR FURTHER INFORMATION CONTACT: Mae 1. EPA Response to the Clean Air Act 10. Incorrect Statement of Baseline Wang, EPA Region IX, (415) 947–4124, Advisory Committee Letter Emissions [email protected]. 2. Consideration of Rule 3170 as an 11. Ambiguity on Fees for Both VOCs and Alternative Program NOX SUPPLEMENTARY INFORMATION: 3. Exemption for Units That Begin 12. Definition of ‘‘Major Source’’ Throughout this document, ‘‘we,’’ ‘‘us’’ Operation After the Attainment Year 13. Sunset Provision for Section 185 Fees 4. Exemption for ‘‘Clean Emission Units’’ and ‘‘our’’ refer to EPA. III. EPA Action 5. Defining the Baseline Period as the IV. Statutory and Executive Order Reviews Table of Contents Attainment Year and the Immediately Preceding Year I. Proposed Action I. Proposed Action 6. Allowing Averaging Over 2–5 Years To On August 19, 2009 (74 FR 41826), II. Public Comments and EPA Responses Establish Baseline Emissions EPA proposed a limited approval and A. Commenting Parties 7. Stationary Versus Mobile Sources limited disapproval of the following B. Summary of Comments and EPA 8. Impacts of Rule 3170 on Small rule that was submitted for Responses Businesses 9. Unintended Consequences of Rule 3170 incorporation into the California SIP.

Local agency Rule No. Rule title Adopted Submitted

SJVUAPCD ...... 3170 Federally Mandated Ozone Nonattainment Fee ...... 05/16/02 08/06/02

We proposed a limited approval 5. The Clean Energy Group, letter Comments: Several commenters because we determined that this rule from Michael Bradley, dated September specifically requested that EPA respond improves the SIP and is largely 18, 2009. to the CAAAC letter prior to taking final consistent with the relevant CAA 6. County Sanitation Districts of Los action on SJVUAPCD Rule 3170. requirements. We simultaneously Angeles County, letter from Stephen R. Commenters also suggested that EPA proposed a limited disapproval because Maguin and Gregory M. Adams, dated provide final guidance regarding some rule provisions do not fully meet August 11, 2009. flexibility under either CAA section 185 the statutory CAA section 185 7. County Sanitation Districts of Los or 172(e) before disapproving any requirement. These provisions include Angeles County, letter from Stephen R. elements of SJVUAPCD Rule 3170. the following: Maguin and Gregory M. Adams, dated Response: EPA intends to respond 1. An exemption for units that begin September 18, 2009. more fully to the issues raised by the operation after the attainment year. 8. EarthJustice, letter from Paul Cort, CAAAC letter. EPA, however, cannot 2. An exemption for any ‘‘clean dated September 18, 2009. delay action on SJVUAPCD Rule 3170 9. San Joaquin Valley Unified APCD, emission unit.’’ because we are under a legal obligation letter from Seyed Sadredin, dated 3. The definition of the baseline to sign a Federal Register notice for our September 17, 2009. period as two consecutive years. final action on Rule 3170 by December 10. The Section 185 Working Group, 11, 2009. This obligation is imposed by 4. The allowance of averaging letter from Jason C. Moore, Baker Botts, baseline emissions over a period of a consent decree between EPA and the dated August 13, 2009. Center for Race, Poverty and the 2–5 years ‘‘if those years are determined 11. Southern California Air Quality Environment (CRPE) to settle CRPE’s by the APCO as more representative of Alliance, letter from Curtis L. Coleman, litigation alleging that EPA had failed to normal source operation.’’ Esq., dated August 12, 2009. 5. An inappropriate definition of the 12. Western States Petroleum act on Rule 3170 in a timely manner. term ‘‘Major Source.’’ Our proposed Association, letter from David R. The consent decree was entered on action contains more information on the Farabee, Pillsbury Winthrop Shaw August 18, 2009, by the U.S. District basis for this rulemaking and on our Pittman LLP, dated September 18, 2009. Court for the Northern District of evaluation of the submittal. California, case number 08–cv–05650 B. Summary of Comments and EPA CW. II. Public Comments and EPA Responses We note that CAA section 172(e) does Responses The comments and our responses are not directly apply to the transition from A. Commenting Parties summarized below. The comments have the 1-hour ozone standard to the 1997 been grouped into general categories. 8-hour ozone standard because that EPA’s proposed action provided a 30- provision applies only where the day public comment period. During this 1. EPA Response to the Clean Air Act revised standard is less stringent than period, we received the following 12 Advisory Committee Letter the standard it replaces. However, comment letters from 11 parties: On May 15, 2009, the Clean Air Act because the CAA does not directly 1. American Chemistry Council, letter Advisory Committee (CAAAC) sent a address anti-backsliding where there is from Lorraine Gershman, dated letter to EPA Acting Assistant a new more stringent standard, EPA September 18, 2009. Administrator Elizabeth Craig regarding determined to apply the principles of 2. American Petroleum Institute, letter issues related to the implementation of CAA section 172(e) for purposes of from Ted Steichen, dated September 18, CAA section 185. The CAAAC asked addressing anti-backsliding for the 2009. EPA to review and address whether it is transition from the 1-hour standard to 3. Association of Irritated Residents, ‘‘legally permissible under either section the 1997 8-hour standard. EPA also letter from Brent Newell, Center on 185 or 172(e) of the Clean Air Act for notes that the State has not requested Race, Poverty, and the Environment, a State to exercise discretion’’ to develop that EPA review Rule 3170 pursuant to dated September 18, 2009. fee program SIPs employing one or more the principles in CAA section 172(e) 4. California Small Business Alliance, of a list of CAAAC-identified program and thus, for purposes of taking action letter from William R. La Marr, dated options (see http://www.epa.gov/air/ on Rule 3170, it is not necessary for EPA August 11, 2009. caaac/185wg). to take a final position regarding

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whether it could approve a substitute application of the principles in section Response: CAA section 185 does not program for the program specified under 172(e) to the anti-backsliding provide for an exemption for units CAA section 185. requirements for the 1-hour standard beginning operation after the attainment would provide EPA with the discretion year. Rather, it requires that ‘‘each major 2. Consideration of Rule 3170 as an to authorize an alternative program. stationary source’’ must pay the fee and Alternative Program Also, as noted above, EPA has not yet that the baseline emissions are those CAAAC’s May 15, 2009, letter stated whether it would approve such from the major source in the attainment identifies as a program option an programs for purposes of the anti- year. The word ‘‘each’’ does not lend exemption from fees for ‘‘well- backsliding requirements of the 1-hour itself to an interpretation that would controlled’’ sources. In our proposed ozone standard. exclude new major sources or new units action on Rule 3170, we noted this Because the State has not submitted at existing major sources from the fee exemption as a basis for not being able the program as an alternative program obligation. The equity concerns cannot to fully approve the rule as meeting consistent with the principles in CAA override the statutory requirement. section 185 of the Act. We further noted section 172(e), EPA is not required to ‘‘ ’’ that the State has not requested that take a position in this rulemaking on 4. Exemption for Clean Emission Units EPA review the SIP to determine whether it would approve such Section 4.3 of SJVUAPCD Rule 3170 whether it would be equivalent to CAA alternatives or whether the submitted exempts any ‘‘clean emission unit’’ from section 185 under the principles of program is consistent with those the requirements of the rule. Section 3.6 section 172(e) and has not made a principles. We will continue to work defines a clean emission unit as a unit demonstration that the program it has with the State to ensure that they adopt that is equipped with an emissions submitted would ensure controls that a program that is fully consistent with control technology that either has a are ‘‘not less stringent’’ than those the requirements of the CAA. minimum 95% control efficiency (85% required under section 185. Thus, we for lean-burn internal combustion stated that we were not addressing 3. Exemption for Units That Begin engines), or meets the requirements for whether it is legally permissible for a Operation After the Attainment Year achieved-in-practice Best Achievable State to adopt an alternative program at Section 4.2 of SJVUAPCD Rule 3170 Control Technology as accepted by the least as stringent as a section 185 fee exempts units that begin operation after APCO during the 5 years immediately program, or if so, whether such the attainment year. In its proposed prior to the end of the attainment year. alternative program could contain a action, EPA stated that CAA section 185 The District’s staff report for Rule 3170 clean unit exemption. does not provide for an exemption for states that the exemption is intended to Comments: One commenter emission units that begin operation after address ‘‘the difficulty of reducing encouraged EPA to work with the attainment year, so this exemption emissions from units with recently SJVUAPCD to consider Rule 3170 as an does not fully comply with the CAA. installed BACT.’’ In its proposed action, alternative program under the Rather, it requires ‘‘each major source’’ EPA expressed that although EPA provisions of CAA section 172(e). The to pay the fee (see CAA section 185(a)). understands the District’s intention, the commenter felt that this rule as written Comments: Several commenters exemption does not comply with CAA would encourage area-wide emission disagreed with EPA’s proposed action section 185, for the same reason as reductions and meet the goals of CAA on this particular provision. They felt noted above for new emission units. section 185 without sacrificing that this exemption is consistent with Comments: Several commenters stringency. the CAA requirements and therefore disagreed with EPA’s proposed action One commenter stated that even if the should not be considered a deficiency. on this particular provision. They felt District had submitted Rule 3170 They also felt that imposing fees on that this exemption is consistent with pursuant to 172(e), or attempts to make these units would be an unfair burden, the CAA requirements and therefore a 172(e) demonstration to justify the resulting in an unfair business should not be considered a deficiency. clean unit exemption or other environment. One commenter expressed Several commenters believe that deficiency, CAA section 172(e) does not that imposing fees on new units would Congress did not intend to impose fees apply in this situation and cannot only serve to hinder the ability of new, on units that are already as clean as justify Rule 3170’s failure to comply cleaner units to displace older, dirtier possible. The imposition of fees on with CAA section 185. The commenter units. Another commenter expressed these units may, in many cases, force a stated that section 172(e) only applies that while CAA section 185 does not curtailment in operations to reduce where EPA has relaxed a national provide an express exemption for new emissions. primary ambient air quality standard units, EPA has sufficient discretion to Two commenters agreed with EPA’s (NAAQS). As a result, CAA section approve the new unit exemption in Rule proposed action on this particular 172(e) does not support the exemptions 3170. provision. They felt that this exemption in Rule 3170. Two commenters agreed with EPA’s violates CAA section 185 requirements Response: We agree with the proposed action on this particular and is a rule deficiency that is a basis comment that CAA section 172(e) does provision. They felt that this exemption for disapproval of the rule. These not directly apply where EPA has violates the requirements of CAA commenters stated that the CAA section promulgated a more stringent NAAQS. section 185 and is a rule deficiency that 185 language is plain and unambiguous, However, as noted above, because the is a basis for disapproval of the rule. clearly does not allow such an Act does not address the principles that One commenter stated that the CAA exemption, that there is no suggestion in apply when there is a transition to a section 185 language is plain and the CAA that the best controlled sources more stringent NAAQS, EPA unambiguous, and clearly does not are entitled to any other ‘‘reward’’ or determined that it was reasonable to allow such an exemption. The other exemption, and that section 185 is not apply the principles in section 172(e). commenter added that there is no a program to penalize only the less- Thus, to the extent section 172(e) would statutory authority for splitting a regulated sources. One commenter authorize EPA to allow alternatives to stationary source into separate emission expressed that Congress understood that statutory programs such as the fee units for the purpose of determining the level of control among sources might program in CAA section 185, EPA’s fees. vary because CAA section 185(b)(2)

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specifies that the baseline comes from Commenters objected to EPA’s view that baseline emissions. CAA section the lower of actuals or allowables, and the five-year lookback option in 185(b)(2) states that EPA may issue that the allowables baseline is to be SJVUAPCD Rule 3170 be available only guidance authorizing such an based on the emissions allowed ‘‘under upon a site-specific consideration of alternative method of calculating the permit’’ unless the source has no representativeness or cyclicality. One baseline emissions. EPA’s Section 185 permit and is only subject to limits commenter stated that NSR reform was Baseline Guidance addresses the issue provided under the SIP. The commenter enacted precisely to replace such a case- of alternative methods for calculating stated that it would defeat this express by-case review. The commenter also baseline emissions. The use of these language to exempt sources from paying stated SJVUAPCD’s approach was alternative methods is associated with a fee based on some arbitrary notion of consistent with EPA’s New Source sources whose emissions are irregular, being ‘‘clean enough.’’ Review approach for multi-year cyclical, or otherwise vary significantly Response: As explained above, CAA baselines. The commenter felt that a from year to year. The averaging period section 185 mandates that the fee is paid simple multi-year baseline would allowed in section 3.2.2 of Rule 3170 by ‘‘each’’ major source based on the flexibly and efficiently satisfy the appears consistent with EPA’s Section emissions from that source in the statutory language and intent. 185 Baseline Guidance. The language in baseline year. There is nothing in the Two commenters agreed with EPA’s section 3.2.2, however, allows such language of CAA section 185 that proposed action on this particular averaging ‘‘if those years are determined contemplates that certain sources or that provision. They felt that this exemption by the APCO as more representative of certain emissions from a source are not violates the CAA section 185 normal source operation.’’ In its subject to the fee. requirements and is a rule deficiency proposed action, EPA stated that it that is a basis for disapproval of the considers this language as less stringent 5. Defining the Baseline Period as the rule. One commenter stated that CAA than the criteria in the CAA, and Attainment Year and the Immediately section 185 language is plain and therefore the rule should be amended to Preceding Year unambiguous, and clearly does not specify use of the expanded averaging Section 3.2.1 of Rule 3170 defines the allow the baseline to be calculated over period only if a source’s emissions are baseline period as two consecutive years two years for all sources. The second irregular, cyclical, or otherwise vary consisting of the attainment year and commenter stated that section 3.2.1 of significantly from year to year. the year immediately prior to the Rule 3170 should be revised to clarify Comments: Several commenters attainment year. In contrast, CAA that the baseline for most sources will disagreed with EPA’s proposed action section 185(b)(2) establishes the be the emissions in the attainment year on this particular provision. They felt attainment year as the baseline period. of 2010, and provide clear criteria for that this exemption is consistent with While CAA section 185(b)(2) also allowing sources to use an alternative the CAA requirements and the Section provides discretion to calculate baseline baseline period. 185 Baseline Guidance, and therefore emissions over a period of more than Response: The language of CAA should not be considered a deficiency. The SJVUAPCD stated that its intention one calendar year, that option is limited section 185 provides EPA with in implementing this provision is that to sources with emissions that are discretion to issue guidance that would the criteria of being ‘‘more irregular, cyclical, or otherwise vary allow for the baseline period to be more representative of normal source significantly from year to year. Thus, in than one calendar year. However, CAA operation’’ would require a source to its proposed action, EPA stated that section 185 allows EPA to do so only for demonstrate to the satisfaction of the section 3.2.1 of SJVUAPCD Rule 3170 is sources whose emissions are irregular, APCO that the emissions are irregular, inconsistent with the CAA because it cyclical, or otherwise vary significantly cyclical, or otherwise vary significantly provides a different baseline than that from year to year. EPA’s Section 185 from year to year. One commenter required by the CAA (two years instead Baseline Guidance referred to this disagreed with EPA’s assessment that of one) regardless of whether the connection by stating that, ‘‘where source emissions are irregular, cyclical, the phrase, ‘‘more representative of emissions are irregular, cyclical or vary normal source operation’’ was less significantly from year to year. or otherwise vary significantly, the CAA provides that the U.S. Environmental stringent that the CAA section 185 Comments: Six commenters disagreed language. with EPA’s proposed action on this Protection Agency (EPA) may issue guidance providing an alternative Two commenters agreed with EPA’s particular provision. They felt that this proposed action on this particular provision is consistent with the CAA method to calculate the baseline amount.’’ EPA issued the Section 185 provision. They felt that this exemption requirements as interpreted in a March violates the CAA section 185 21, 2008 memorandum from William Baseline Guidance to provide guidance for an alternative method for calculating requirements and is a rule deficiency Harnett, Director of the Air Quality that is a basis for disapproval of the Policy Division, to the Regional Air the emissions baseline in these situations. Hence, section 3.2.1 of Rule rule. One commenter stated that the Division Directors, entitled, ‘‘Guidance CAA section 185 language is plain and on Establishing Emissions Baselines 3170 does not conform to CAA section 185 because it allows all sources to unambiguous, and clearly does not under Section 185 of the Clean Air Act allow such an exemption. (CAA) for Severe and Extreme Ozone calculate their baseline over a two-year period, regardless of whether emissions Response: EPA disagrees that Nonattainment Areas that Fail to Attain unlimited APCO discretion in are irregular, cyclical, or otherwise vary the 1-hour Ozone NAAQS by their determining normal source operation is significantly. Attainment Date,’’ (‘‘Section 185 consistent with CAA section 185. Rule Baseline Guidance’’) and therefore 6. Allowing Averaging Over 2–5 Years 3170 does not specify any criteria for should not be considered a deficiency.1 To Establish Baseline Emissions how the APCO would make a Section 3.2.2 of Rule 3170 allows determination that a certain baseline is 1 EPA’s Section 185 Baseline Guidance provides averaging over 2–5 years to establish ‘‘more representative of normal source that an acceptable alternative baseline for sources ’’ whose emissions are irregular, cyclical, or operation than the baseline specified otherwise vary significantly from year to year is the for Prevention of Significant Deterioration of Air by CAA section 185 (i.e., the attainment 10-year lookback period found in EPA’s regulations Quality (PSD) (40 CFR 52.21(b)(48)). year). It is not clear that the APCO’s

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discretion would involve an assessment fees to small businesses that are in of the fee amount. In addition, the of whether a source’s emissions are compliance with all applicable definition of baseline emissions fails to irregular, cyclical, or otherwise variable. regulations will demonstrate that the include the possibility that a source will Therefore, EPA continues to view the fees are unreasonable, expensive, and not have a permit issued for the language in section 3.2.2 of Rule 3170 do nothing to reduce and assure attainment year, in which case the as a deficiency that needs to be emission reductions. One commenter allowable emissions are to be based on corrected. stated that the fees would be the emissions allowed under the inconsistent with the Small Business applicable implementation plan (see 7. Stationary Versus Mobile Sources Regulatory Flexibility Act and that the CAA section 185(b)(2)). While such Comment: Several commenters stated fees should not be applied to businesses circumstances may be rare, the District that most ozone nonattainment areas meeting the definition of ‘‘small’’ under should include language that mirrors classified as severe or extreme are now CAA section 507. the statute to avoid any potential dominated by mobile source emissions, Response: Although CAA section 185 conflict. and that stationary sources are not the allows for exemptions for certain low- Response: While we think it is major contributor of emissions. population areas (see section 185(e)), unlikely that any sources would not fall Commenters stated that CAA section section 185 does not grant States or EPA within the current definition, we agree 185 is functionally obsolete and will discretion to exempt small businesses with the commenter and recommend result in substantial adverse financial from the requirements of the program. that the calculation in section 5.1 of impacts to facility operators with little The Regulatory Flexibility Act applies Rule 3170 be revised to more closely or no air quality benefit. One where EPA is promulgating regulations conform to the language in CAA section commenter stated that individual that may have a significant impact on a 185. The definition of the variable ‘‘B’’ sources do not have the ability to assure substantial number of small businesses. in the fee calculation should include the attainment of the standard; Here, it is the CAA, not EPA’s action clarification that if no permit has been consequently, the fee is an that imposes the fee on sources. issued for the attainment year, then ‘‘B’’ unconstitutional bill of attainder. Moreover, in this instance, EPA is not should be the lower of the actual VOC Response: The approach outlined in promulgating regulations, but rather or emissions during the baseline period, the CAA to reduce emissions in defined reviewing a State plan. EPA does not or the amount of VOC or NOX emissions air basins acknowledges that no single have the authority to consider the allowed under the applicable source is responsible for an area’s impacts on small businesses that result implementation plan during the nonattainment, but that the total from direct application of the statute or baseline period. collective contribution of many through applications of the State 11. Ambiguity on Fees for Both VOCs individual sources affects an area’s program. Moreover, even if EPA were and NO pollution problem. As such, the CAA promulgating a regulation that was X extensively regulates both mobile determined to have a significant impact Comment: One commenter expressed sources and stationary sources. Whether on a substantial number of small that the fee calculation in section 5.0 of or not CAA section 185 is functionally entities, we note that the RFA does not Rule 3170 is ambiguous regarding obsolete is an issue for Congress. As prohibit any specific regulatory result, whether the fee is due for VOCs and long as CAA section 185 remains the as suggested by the commenters. Rather NOX, or just one or the other. Sources law, EPA’s obligation is to ensure it only requires that the Agency take must pay a fee for both VOC emissions compliance with it. We disagree with certain actions in order to fully consider in excess of 80% of the VOC baseline the commenter that claims that since the potential impacts of the regulation. emissions and NOX emissions in excess individual sources cannot ensure of 80% of the NOX baseline emissions. attainment of the ozone NAAQS, section 9. Unintended Consequences of Rule Section 5.0 of Rule 3170 should be 185 is an unconstitutional bill of 3170 revised to clarify this point. attainder. Section 185 does not result in Comment: One commenter stated that Response: EPA agrees that the fee is any party being declared guilty of a renewable energy facilities may need to required for both VOC and NOX crime. Rather, it is a means of reduce throughput as a result of CAA emissions. We believe that the District encouraging certain sources to reduce section 185 requirements and this and sources understand the fee program emissions of pollutants that contribute would be contrary to efforts to reduce applies to both VOC and NOX to unhealthy ambient ozone levels. The greenhouse gases and increase the emissions, and that the language in Courts have long held that the penetration of renewable energy. section 5.1 of SJVUAPCD Rule 3170 is Commerce clause gives Congress the Response: Sources have several ways sufficiently clear in that respect. For authority to regulate sources of air to comply with the requirements of example, the District staff report for pollution. The fee provision of CAA CAA section 185, and this could include Rule 3170 contained a sample fee section 185 acts as an incentive for reducing throughput to eliminate or calculation which also made it clear that major sources of air pollution to reduce reduce the fee amount. Regardless of the a separate fee would be assessed for emissions. Thus, it is a proper exercise consequence of the manner in which a VOC emissions and NOX emissions. of Congressional authority under the major source chooses to comply with While we do not believe any revisions Commerce clause. the requirements, section 185 does not to the rule are necessary, we provide States or EPA with authority to recommend that SJVUAPCD consider 8. Impacts of Rule 3170 on Small exempt major stationary sources from whether further clarification might be Businesses complying with section 185. helpful. Comment: Commenters stated that hundreds of small businesses will be 10. Incorrect Statement of Baseline 12. Definition of ‘‘Major Source’’ affected by CAA section 185 Emissions Section 3.4 of Rule 3170 defines the requirements, as well as hospitals, Comment: One commenter stated that term ‘‘Major Source’’ by referring to the medical centers, schools and other section 5.1 of Rule 3170 needs to be definition in SJVUAPCD Rule 2201 essential public services. Commenters revised to accurately define the baseline (New and Modified Stationary Source stated that applying CAA section 185 emissions to be used in the calculation Review Rule). The current SIP-approved

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version of Rule 2201 was adopted by the the larger of actual or potential we approve subsequent SIP revisions SJVUAPCD on December 19, 2002, and emissions. that correct the rule deficiencies within approved by EPA on May 17, 2004 (69 Response: EPA disagrees with the 24 months. Note that the submitted rule FR 27837). This version of Rule 2201 statement that the December 18, 2008, has been adopted by the SJVUAPCD, defines ‘‘Major Source’’ as a stationary version of Rule 2201 is currently and EPA’s final limited disapproval source with VOC or NOX emissions of binding under State law. That version of does not prevent the local agency from over 50,000 pounds per year (25 tons the rule specifically states that it does enforcing it. per year). The CAA defines the major not go into effect until EPA issues final approval of the rule into the SIP. The IV. Statutory and Executive Order source threshold as 10 tons per year for Reviews ozone nonattainment areas classified as ‘‘Major Source’’ definition in Rule 3170 extreme. The SJVUAPCD amended Rule continues to be a deficiency until it is A. Executive Order 12866, Regulatory 2201 on December 18, 2008, and revised to be consistent with the CAA. Planning and Review submitted it for inclusion in the SIP on Further, we agree that since we have not The Office of Management and Budget March 17, 2009. This amended version yet fully reviewed and acted on Rule (OMB) has exempted this regulatory includes the 10 tons per year threshold, 2201, we cannot say for a certainty that action from Executive Order 12866, but has not been approved into the SIP. approval of that rule would eliminate entitled ‘‘Regulatory Planning and Therefore, in its proposed action, EPA any deficiency with respect to the Review.’’ stated that Rule 3170’s reliance on Rule definition of major sources under Rule 2201 to define major sources is not 3170. We will continue to work with the B. Paperwork Reduction Act approvable at this time. If a version of State to ensure that it develops a section This action does not impose an Rule 2201 that contains the appropriate 185 program that fully complies with information collection burden under the major source threshold is approved into the Act. provisions of the Paperwork Reduction the SIP prior to finalizing the proposed 13. Sunset Provision for Section 185 Act, 44 U.S.C. 3501 et seq. Burden is action, then section 3.4 would no longer Fees defined at 5 CFR 1320.3(b). be cited as a deficiency in Rule 3170. Comment: One commenter C. Regulatory Flexibility Act Comments: Several commenters highlighted the need for EPA to address disagreed with EPA’s proposed action The Regulatory Flexibility Act (RFA) the legality and process of establishing generally requires an agency to conduct on this particular provision. They felt a sunset provision for section 185 fees, that this discrepancy would be resolved a regulatory flexibility analysis of any an issue identified in the CAAAC letter. rule subject to notice and comment prior to the assessment or collection of Because the 1-hour ozone standard has any section 185 fees when Rule 2201 is rulemaking requirements unless the been replaced with the 8-hour standard, agency certifies that the rule will not approved into the SIP. One commenter EPA may not be able to make the also expressed that the thresholds in have a significant economic impact on findings necessary to redesignate an a substantial number of small entities. Rule 2201 are currently binding under area as attainment for the 1-hour Small entities include small businesses, State law, and therefore the ‘‘Major standard. This situation would require small not-for-profit enterprises, and Source’’ definition in Rule 3170 should the imposition of fees indefinitely. The small governmental jurisdictions. not be considered a deficiency that commenter feels that this issue must be This rule will not have a significant would result in the disapproval of the resolved if EPA finalizes action on Rule impact on a substantial number of small rule. 3170. entities because SIP approvals and Two commenters agreed with EPA’s Response: EPA is aware of the issue limited approvals/limited disapprovals proposed action on this particular raised by the commenter and intends to under section 110 and subchapter I, part provision. One commenter felt that this address in future guidance or D of the Clean Air Act do not create any definition is currently inconsistent with rulemaking the issue of when section new requirements but simply approve CAA requirements, noting that EPA has 185 fees would no longer apply. requirements that the State is already allowed Rule 2201 to remain out of date III. EPA Action imposing. Therefore, because this for 5 years. However, in the current limited approval/limited disapproval situation, the commenter agreed that No comments were submitted that action does not create any new this definition is a rule deficiency that change our assessment of the rule as requirements, I certify that this action is a basis for disapproval of the rule. described in our proposed action. will not have a significant economic One commenter added that the Therefore, as authorized in sections impact on a substantial number of small definition of ‘‘Major Source’’ in Rule 110(k)(3) and 301(a) of the Act, EPA is entities. 2201 does not match the definition in finalizing a limited approval of the Moreover, due to the nature of the CAA section 182(e). For example, Rule submitted rule. This action incorporates Federal-State relationship under the 2201’s definition excludes fugitive the submitted rule into the California Clean Air Act, preparation of flexibility emissions for certain sources, only SIP, including those provisions analysis would constitute Federal includes potential emissions from units identified as deficient. As authorized inquiry into the economic with valid permits, and credits limits in under section 110(k)(3), EPA is reasonableness of State action. The authorities to construct that may or may simultaneously finalizing a limited Clean Air Act forbids EPA to base its not reflect actual emissions. As a result, disapproval of the rule. As a result, actions concerning SIPs on such the commenter felt that EPA is incorrect sanctions will be imposed unless EPA grounds. Union Electric Co., v. U.S. in suggesting that this deficiency will be approves subsequent SIP revisions that EPA, 427 U.S. 246, 255–66 (1976); 42 resolved once the revised version of correct the rule deficiencies within 18 U.S.C. 7410(a)(2). Rule 2201 is approved into the SIP. The months of the effective date of this commenter felt that section 3.4 of Rule action. These sanctions will be imposed D. Unfunded Mandates Reform Act 3170 should be revised to mirror the under section 179 of the Act according Under sections 202 of the Unfunded definition of ‘‘major source’’ in CAA to 40 CFR 52.31. In addition, EPA must Mandates Reform Act of 1995 section 182(e), which includes all promulgate a Federal implementation (‘‘Unfunded Mandates Act’’), signed into emissions of VOC or NOX, and looks at plan (FIP) under section 110(c) unless law on March 22, 1995, EPA must

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prepare a budgetary impact statement to This rule will not have substantial (NTTAA) of 1995 requires Federal accompany any proposed or final rule direct effects on the States, on the agencies to evaluate existing technical that includes a Federal mandate that relationship between the national standards when developing a new may result in estimated costs to State, government and the States, or on the regulation. To comply with NTTAA, local, or Tribal governments in the distribution of power and EPA must consider and use ‘‘voluntary aggregate; or to the private sector, of responsibilities among the various consensus standards’’ (VCS) if available $100 million or more. Under section levels of government, as specified in and applicable when developing 205, EPA must select the most cost- Executive Order 13132, because it programs and policies unless doing so effective and least burdensome merely approves a State rule would be inconsistent with applicable alternative that achieves the objectives implementing a Federal standard, and law or otherwise impractical. of the rule and is consistent with does not alter the relationship or the statutory requirements. Section 203 distribution of power and The EPA believes that VCS are requires EPA to establish a plan for responsibilities established in the Clean inapplicable to this action. Today’s informing and advising any small Air Act. Thus, the requirements of action does not require the public to governments that may be significantly section 6 of the Executive Order do not perform activities conducive to the use or uniquely impacted by the rule. apply to this rule. of VCS. EPA has determined that the limited approval/limited disapproval action F. Executive Order 13175, Coordination J. Congressional Review Act With Indian Tribal Governments promulgated does not include a Federal The Congressional Review Act, 5 mandate that may result in estimated Executive Order 13175, entitled U.S.C. 801 et seq., as added by the Small costs of $100 million or more to either ‘‘ Consultation and Coordination with Business Regulatory Enforcement State, local, or Tribal governments in Indian Tribal Governments’’ (65 FR Fairness Act of 1996, generally provides the aggregate, or to the private sector. 67249, November 9, 2000), requires EPA that before a rule may take effect, the This Federal action approves pre- to develop an accountable process to agency promulgating the rule must existing requirements under State or ensure ‘‘meaningful and timely input by local law, and imposes no new Tribal officials in the development of submit a rule report, which includes a requirements. Accordingly, no regulatory policies that have Tribal copy of the rule, to each House of the additional costs to State, local, or Tribal implications.’’ This final rule does not Congress and to the Comptroller General governments, or to the private sector, have Tribal implications, as specified in of the United States. EPA will submit a result from this action. Executive Order 13175. It will not have report containing this rule and other required information to the U.S. Senate, E. Executive Order 13132, Federalism substantial direct effects on Tribal governments, on the relationship the U.S. House of Representatives, and Federalism (64 FR 43255, August 10, between the Federal government and the Comptroller General of the United 1999) revokes and replaces Executive Indian Tribes, or on the distribution of States prior to publication of the rule in Orders 12612 (Federalism) and 12875 power and responsibilities between the the Federal Register. A major rule (Enhancing the Intergovernmental Federal government and Indian Tribes. cannot take effect until 60 days after it Partnership). Executive Order 13132 Thus, Executive Order 13175 does not is published in the Federal Register. requires EPA to develop an accountable apply to this rule. This action is not a ‘‘major rule’’ as process to ensure ‘‘meaningful and defined by 5 U.S.C. 804(2). This rule timely input by State and local officials G. Executive Order 13045, Protection of in the development of regulatory Children From Environmental Health will be effective February 12, 2010. policies that have federalism Risks and Safety Risks K. Petitions for Judicial Review implications.’’ ‘‘Policies that have EPA interprets Executive Order 13045 federalism implications’’ is defined in (62 FR 19885, April 23, 1997) as Under section 307(b)(1) of the Clean the Executive Order to include applying only to those regulatory Air Act, petitions for judicial review of regulations that have ‘‘substantial direct actions that concern health or safety this action must be filed in the United effects on the States, on the relationship risks, such that the analysis required States Court of Appeals for the between the national government and under section 5–501 of the Executive appropriate circuit by March 15, 2010. the States, or on the distribution of Order has the potential to influence the Filing a petition for reconsideration by power and responsibilities among the regulation. This rule is not subject to the Administrator of this final rule does various levels of government.’’ Under Executive Order 13045, because it not affect the finality of this rule for the Executive Order 13132, EPA may not approves a State rule implementing a purposes of judicial review nor does it issue a regulation that has federalism Federal standard. extend the time within which a petition implications, that imposes substantial for judicial review may be filed, and direct compliance costs, and that is not H. Executive Order 13211, Actions That shall not postpone the effectiveness of required by statute, unless the Federal Significantly Affect Energy Supply, such rule or action. This action may not government provides the funds Distribution, or Use necessary to pay the direct compliance be challenged later in proceedings to This rule is not subject to Executive enforce its requirements (see section costs incurred by State and local ‘‘ Order 13211, Actions Concerning 307(b)(2)). governments, or EPA consults with Regulations That Significantly Affect State and local officials early in the Energy Supply, Distribution, or Use’’ (66 List of Subjects in 40 CFR Part 52 process of developing the proposed FR 28355, May 22, 2001) because it is regulation. EPA also may not issue a not a significant regulatory action under Environmental protection, Air regulation that has federalism Executive Order 12866. pollution control, Incorporation by implications and that preempts State reference, Intergovernmental relations, law unless the Agency consults with I. National Technology Transfer and Nitrogen dioxide, Ozone, Reporting and State and local officials early in the Advancement Act recordkeeping requirements, Volatile process of developing the proposed Section 12 of the National Technology organic compounds. regulation. Transfer and Advancement Act

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Dated: December 11, 2009. Atmospheric Administration (NOAA), in 2010 in the Chiniak Gully Research Laura Yoshii, Commerce. Area. Therefore, the Regional Acting Regional Administrator, Region IX. ACTION: Temporary rule. Administrator is rescinding the trawl ■ Part 52, Chapter I, Title 40 of the Code closure of the Chiniak Gully Research SUMMARY: NMFS is rescinding the trawl of Federal Regulations is amended as Area. All other closures remain in full closure in the Chiniak Gully Research follows: force and effect. Area. This action is necessary to allow PART 52—[AMENDED] vessels using trawl gear to participate in Classification directed fishing for groundfish in the ■ 1. The authority citation for part 52 Chiniak Gully Research Area. Pursuant to 5 U.S.C. 553 (b)(B), the continues to read as follows: DATES: Effective 1200 hrs, Alaska local Assistant Administrator for Fisheries, Authority: 42 U.S.C. 7401 et seq. time (A.l.t.), August 1, 2010, through NOAA (AA) finds good cause to waive 1200 hrs, A.l.t., September 20, 2010. prior notice and an opportunity for Subpart F—California FOR FURTHER INFORMATION CONTACT: public comment on this action, as notice and comment is unnecessary. Notice ■ Obren Davis, 907–586–7228. 2. Section 52.220 is amended by and comment is unnecessary because adding paragraph (c)(303)(i)(C)(4) to SUPPLEMENTARY INFORMATION: NMFS the rescission of the trawl closure is read as follows: manages the groundfish fishery in the Gulf of Alaska (GOA) exclusive non-discretionary; pursuant to § 52.220 Identification of plan. economic zone according to the Fishery § 679.22(b)(6)(ii)(B), the Regional * * * * * Management Plan for Groundfish of the Administrator has no choice but to (c) * * * Gulf of Alaska (FMP) prepared by the rescind the trawl closure once it is (303) * * * North Pacific Fishery Management determined that research activities will (i) * * * Council under authority of the not be conducted in the area. (C) * * * Magnuson-Stevens Fishery (4) Rule 3170, ‘‘Federally Mandated Pursuant to 5 U.S.C. 553(d)(1), this Conservation and Management Act. rule is not subject to the 30–day delay Ozone Nonattainment Fee,’’ adopted on Regulations governing fishing by U.S. May 16, 2002. in effective date requirement of 5 U.S.C. vessels in accordance with the FMP 553(d) since the rule relieves a * * * * * appear at subpart H of 50 CFR part 600 restriction. [FR Doc. 2010–353 Filed 1–12–10; 8:45 am] and 50 CFR part 679. BILLING CODE 6560–50–P The Chiniak Gully Research Area is This action has been determined to be closed to vessels using trawl gear from not significant for purposes of Executive August 1 to a date no later than Order 12866. DEPARTMENT OF COMMERCE September 20 under regulations at Authority: 16 U.S.C. 1801 et seq. § 679.22(b)(6)(ii)(A). This closure is in National Oceanic and Atmospheric support of a research project to evaluate Dated: January 7, 2010. Administration the effects of commercial fishing on Emily H. Menashes, pollock distribution and abundance, as Acting Director, Office of Sustainable 50 CFR Part 679 part of a comprehensive investigation of Fisheries, National Marine Fisheries Service. [Docket No.0910091344–9056–02] Stellar sea lion and commercial fishery [FR Doc. 2010–495 Filed 1–12–10; 8:45 am] interactions. BILLING CODE 3510–22–S RIN 0648–XT71 The regulations at § 679.22(b)(6)(ii)(B) Fisheries of the Exclusive Economic provide that the Regional Administrator, Zone Off Alaska; Chiniak Gully Alaska Region, NMFS, (Regional Research Area for Vessels Using Trawl Administrator) shall rescind the trawl Gear closure if relevant research activities will not be conducted. The Regional AGENCY: National Marine Fisheries Administrator has determined that Service (NMFS), National Oceanic and research activities will not be conducted

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Proposed Rules Federal Register Vol. 75, No. 8

Wednesday, January 13, 2010

This section of the FEDERAL REGISTER proposed to make any such changes as Preliminary Statement contains notices to the public of the proposed may be necessary to the order to The proposed amendments are based issuance of rules and regulations. The conform to any amendment that may purpose of these notices is to give interested on the record of a public hearing held result from the hearing. on February 21 and 22, 2007, in Grand persons an opportunity to participate in the A Board proposal to revise the voting rule making prior to the adoption of the final Rapids, Michigan, and March 1 and 2, rules. requirements necessary to approve a 2007, in Provo, Utah, to consider such Board action is not recommended for amendments to the order. The hearing adoption. was held pursuant to the provisions of DEPARTMENT OF AGRICULTURE The amendments are designed to the Agricultural Marketing Agreement provide flexibility in administering the Act of 1937, as amended (7 U.S.C. 601– Agricultural Marketing Service volume control provisions of the order 674), hereinafter referred to as the ‘‘Act’’, and to update Board nomination, and the applicable rules of practice and 7 CFR Part 930 election, and membership requirements. procedure governing the formulation of [Docket No. AO–370–A8; AMS–FV–06–0213; The amendments are intended to marketing agreements and orders (7 CFR FV07–930–2] improve the operation and Part 900). administration of the order. Notice of this hearing was published Tart Cherries Grown in the States of DATES: The referendum will be in the Federal Register on February 7, Michigan, New York, Pennsylvania, conducted from February 1, 2010, 2007, and contained amendment Oregon, Utah, Washington, and through February 13, 2010. The proposals submitted by the Board. Wisconsin; Secretary’s Decision and representative period for the purpose of The amendments included in this Referendum Order on Proposed the referendum will be July 1, 2008 decision would: Amendment of Marketing Agreement through June 30, 2009. 1. Amend § 930.50 of the order to and Order No. 930 authorize changing the primary reserve FOR FURTHER INFORMATION CONTACT: capacity associated with the volume AGENCY: Agricultural Marketing Service, Martin Engeler, Marketing Order control provisions of the order. USDA. Administration Branch, Fruit and 2. Amend § 930.54 of the order to ACTION: Proposed rule and referendum Vegetable Programs, AMS, USDA, 2202 authorize establishment of a minimum order. Monterey Street, Suite 102–B, Fresno, inventory level at which all remaining California 93721; telephone: (559) 487– product held in reserves would be SUMMARY: This decision proposes 5110, Fax: (559) 487–5906; or Marc released to handlers for use as free amendments to Marketing Agreement McFetridge, Marketing Order tonnage. and Order No. 930 (order), which Administration Branch, Fruit and 3. Amend § 930.55 to establish an age regulates the handling of tart cherries Vegetable Programs, AMS, USDA, 1400 limitation on product placed into grown in Michigan, New York, Independence Avenue, SW., Stop 0237, reserves. Pennsylvania, Oregon, Utah, Washington, DC 20250–0237; telephone: 4. Amend § 930.23 to revise the Washington, and Wisconsin, and (202) 720–1509, Fax: (202) 720–8938, or nomination and election process for provides growers and processors with e-mail: [email protected] or handler members on the Board, the opportunity to vote in a referendum [email protected]. including revisions to conform this to determine if they favor the changes. Small businesses may request section to amendment of § 930.20 Seven amendments were proposed by information on this proceeding by regarding membership affiliation the Cherry Industry Administrative contacting Jay Guerber, Marketing Order requirements. Board (Board), which is responsible for Administration Branch, Fruit and 5. Amend § 930.20 to revise Board local administration of the order. These Vegetable Programs, AMS, USDA, 1400 membership affiliation requirements. amendments would: Authorize Independence Avenue, SW., Stop 0237, 6. Amend § 930.23 to update order changing the primary reserve capacity Washington, DC 20250–0237; language to more accurately reflect associated with the volume control Telephone: (202) 720–2491, Fax: (202) grower and handler participation in the provisions of the order; authorize 720–8938, e-mail: nomination and election process in establishment of a minimum inventory [email protected]. Districts with only one Board level at which all remaining product representative. held in reserves would be released to SUPPLEMENTARY INFORMATION: Prior In addition to the proposed handlers for use as free tonnage; documents in this proceeding: Notice of amendments to the order, AMS establish an age limitation on product Hearing issued on February 5, 2007, and proposed to make any such additional placed into reserves; revise the published in the February 7, 2007, issue changes as may be necessary to the nomination and election process for of the Federal Register (72 FR 5646), order to conform to any amendments handler members on the Board; revise and a Recommended Decision issued on that may result from the hearing. To the Board membership affiliation May 7, 2009 and published in the May extent necessary, conforming changes requirements; and update order 12, 2009, issue of the Federal Register have been made to the amendments. language to more accurately reflect (74 FR 22112). A Board proposal to revise the voting grower and handler participation in the This action is governed by the requirements necessary to approve a nomination and election process in provisions of sections 556 and 557 of Board action is not recommended for districts with only one Board title 5 of the United States Code and is adoption. representative. In addition, the therefore excluded from the Upon the basis of evidence Agricultural Marketing Service (AMS) requirements of Executive Order 12866. introduced at the hearing and the record

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thereof, the Administrator of AMS on cherries in the regulated area. A subsequently requested that USDA May 7, 2009, filed a Recommended majority of the producers, processors, conduct a hearing to consider the Decision and Opportunity to File and handlers are considered small proposed amendments. The views of all Written Exceptions thereto by June 11, entities according to the SBA’s participants were considered 2009. definition. throughout this process. Six exceptions were filed during the The geographic region regulated In addition, the hearing to receive period provided. Five of the exceptions under the order covers the States of evidence on the proposed amendments were filed by growers and processors of Michigan, New York, Oregon, was open to the public and all tart cherries, and one was filed on Pennsylvania, Utah, Washington, and interested parties were invited and behalf of the Board. All of the Wisconsin. Acreage devoted to tart encouraged to participate and express exceptions expressed concern about cherry production in the regulated area their views. Material Issue Number 6 regarding has declined in recent years. According The proposed amendments are membership affiliation requirements. to data presented at the hearing, bearing intended to provide additional Five of the exceptions raised specific acreage in 1987–88 totaled 50,050 acres; flexibility in administering the volume concerns with the changes AMS made by 2006–2007 it had declined to 37,200 control provisions of the order, and to in the Recommended Decision to the acres. Michigan accounts for 74 percent update Board nomination, election, and industry’s proposed amendment under of total U.S. bearing acreage with 27,700 membership requirements. The Material Issue Number 5 regarding the bearing acres. Utah is second, with a amendments are intended to improve nomination and election process of reported 2,800 acres, or approximately the operation and administration of the Board members, and its application in eight percent of the total. The remaining order. Record evidence indicates the conjunction with Material Issue Number States’ acreage ranges from 700 to 2,000 proposals are intended to benefit all 6. Two of the exceptions addressed acres. producers and handlers under the order, Material Issue Number 4 regarding the Production of tart cherries can regardless of size. proposal to change Board voting fluctuate widely from year to year. The Amendment 1—Adding the Authority requirements. One exception addressed magnitude of these fluctuations is one of To Change the Primary Reserve Material Issue Number 1 concerning the most pronounced for any Capacity changing the reserve capacity through agricultural commodity in the United informal rulemaking, Material Issue States, and is due in large part to This amendment would revise Number 2 concerning establishment of a weather related conditions during the § 930.50 of the order to authorize minimum inventory level at which bloom and growing seasons. This changing the primary reserve capacity reserve product would be released to fluctuation in supplies presents a associated with the volume provisions handlers as free tonnage, and Material marketing challenge for the tart cherry of the order through informal Issue Number 3 concerning placing an industry because demand for the rulemaking. Changing the reserve age limitation on reserve products. The product is relatively static. In addition, capacity currently requires amendment specific issues raised in these the demand for tart cherries is inelastic, of the order through the formal exceptions are discussed in the Findings which means a change in the supply has rulemaking process. and Conclusions; Discussions of a proportionately larger change in the The order establishes a fixed quantity Exceptions section of this document. price level. of 50-million pounds of tart cherries and Authorities under the order include tart cherry products that can be held in Small Business Considerations volume regulation, promotion and the primary reserve. Any reserve Pursuant to the requirements set forth research, and grade and quality product in excess of the 50-million- in the Regulatory Flexibility Act (RFA), standards. Volume regulation is used pound limitation must be placed in the AMS has considered the economic under the order to augment supplies secondary reserve. impact of this action on small entities. during short supply years with product Free tonnage product can be sold to Accordingly, AMS has prepared this placed in reserves during large supply any market outlet, but most shipments final regulatory flexibility analysis. years. This practice is intended to are sold domestically, which is The purpose of the RFA is to fit reduce the annual fluctuations in considered the primary market. Reserve regulatory actions to the scale of supplies and corresponding fluctuations product can be used only in specific business subject to such actions so that in prices. outlets which are considered secondary small businesses will not be unduly or The Board is comprised of markets. These secondary markets disproportionately burdened. Marketing representatives from all producing areas include development of export markets, orders and amendments thereto are based on the volume of cherries new product development, new unique in that they are normally produced in those areas. The Board markets, and government purchases. brought about through group action of consists of a mix of handler and grower When the order was promulgated, a essentially small entities for their own members, and a member that represents 50-million-pound limitation was placed benefit. the public. Board meetings where on the capacity of the primary reserve. Small agricultural producers have regulatory recommendations and other Proponents of the current order been defined by the Small Business decisions are made are open to the proposed a limitation on the quantity of Administration (SBA) (13 CFR 121.201) public. All members are able to product that could be placed into the as those having annual receipts of less participate in Board deliberations, and primary reserve. That limitation was than $750,000. Small agricultural each Board member has an equal vote. incorporated into the order, and can service firms, which include handlers Others in attendance at meetings are only be changed through the formal regulated under the order, are defined as also allowed to express their views. rulemaking process. those with annual receipts of less than The Board appointed a subcommittee Economic data presented when the $7,000,000. to consider amendments to the order was promulgated indicated that a There are approximately 40 handlers marketing order. The subcommittee met reserve program could benefit the and processors of tart cherries subject to several times for this purpose, and industry by managing fluctuating regulation under the order and ultimately recommended several supplies. Witnesses at the February and approximately 900 producers of tart amendments to the order. The Board March 2007 hearing indicated the order

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has been successful in this regard. stated that when inventory levels reach to each handler’s share of the entire However, the record indicated that the a minimal amount the costs of tracking industry’s reserve inventory. Each order could be more flexible in allowing inventory outweigh the benefit from handler’s reserve inventory obligation is modifications to the 50-million-pound carrying inventory in the primary based on the handler’s share of the total limitation should conditions warrant reserve. crop handled. Thus, small handlers such a change in the future. A significant portion of the Board would not be disproportionately If the reserve capacity was changed, staff’s time is directed at tracking burdened. costs associated with storing product in reserve inventory maintained at It is anticipated that the benefits of reserves could also change. In addition, handlers’ facilities. Hearing witnesses providing a good quality product in to the extent such a change could affect testified that while it is difficult to reserves to ultimately supply markets supplies in the marketplace; returns to quantify the exact value of the Board when needed would outweigh any costs both growers and handlers could also be staff’s time to conduct these activities, associated with implementation of this affected. the time could be better spent on other amendment. Any Board recommendation to change industry issues, and it is unnecessary to Amendment 4—Revision of Nomination the reserve capacity would be required track minimal levels of inventory. to be implemented through the informal The amendment, if implemented, and Election Process for Handler rulemaking process. As part of the could have a positive impact on the Members on the Board informal rulemaking process, USDA market. As inventories are released from This amendment relates to expects that any Board recommendation the reserves, products could be sold, nomination and election of Board will include an analysis of the pertinent generating revenue for the industry. members under § 930.23 of the order. It factors and issues, including the impact If implemented, this amendment is would require a handler to receive of a proposed regulation on producers expected to reduce costs to handlers and support from handlers that handled at and handlers. During that process, the the Board, thus having a positive least five percent of the average Board would recommend a change to economic impact. production of tart cherries in the applicable district in order to be a USDA, and only if the recommendation Amendment 3—Establishing an Age candidate and to be elected by the was accompanied by adequate Limitation on Products Placed Into industry and recommended to the justification would USDA proceed with Reserves the change. Secretary for Board membership. Under This amendment would revise the current order, there is no accounting Amendment 2—Adding the Authority § 930.55 to require that products placed for handler volume in the nomination To Establish a Minimum Inventory in reserves must have been produced in and balloting process. Each handler is Level at Which Reserves Would Be the current or immediately preceding entitled to one equal vote. This proposal Released two crop years. If implemented, this would continue to allow each handler to This amendment would revise amendment would allow the Board to have one vote, but would also require § 930.54 of the order to provide the place an age limit on products carried handler candidates to be supported by Board with the authority to establish a in the reserve. The purpose of the handlers representing at least five minimum inventory level at which amendment would be to help ensure percent of the average production in the reserves would be released and made that products of saleable quality are applicable district to be eligible to run available to handlers as free tonnage. maintained in reserve inventories. for a Board position and to be elected This amendment would allow the Board Witness supported the amendment by by the industry for recommendation to to clear out the primary reserve and stating that it would add credibility to the Secretary. This would help to ensure subsequently the secondary reserve product quality for all products carried that handler members on the Board when a specified minimum inventory in the reserve. Currently, handlers can represent the interests of handlers in level of tart cherries is reached. The carry products they have no intention of their district that account for at least a specified minimum level would be selling just to meet their reserve minimal percentage of the volume in the established through the informal obligation. This amendment would district. The amendment proposed by rulemaking process. require handlers to rotate product in the Board was modified by AMS. The Under current order provisions, their reserve inventory, thus preventing amendment as modified by AMS would handlers cannot access the secondary them from maintaining the same not apply the five percent support reserve until the primary reserve is product in the reserve year after year. requirements to candidates whose empty. Based on current language of the Product held in inventory tends to potential election could prevent a sales order, one handler who has not deteriorate over time. When reserve constituency conflict from occurring, as completely disposed of or otherwise product is ultimately released for sale to discussed under amendment number fulfilled its reserve obligation can meet market demand, this proposed five. The modification would help to prevent access to the secondary reserve. amendment would help ensure the ensure that all qualified handlers could The amendment would allow the reserve product available is in saleable participate in the election process. Board to clear out the primary reserve condition and can satisfy the market’s This proposed amendment is not when inventory levels are at a minimum needs. Assuring product is available to anticipated to have a significant level in order to provide the industry satisfy the market helps to foster long- economic impact on small businesses. It access to secondary reserve inventories. term market stability. only affects the nomination and election If the amendment were implemented, In terms of costs, handlers may criteria for membership on the Board by costs to both handlers and the Board experience some minimal costs adding volume as an element of support could be reduced. Handlers incur costs associated with periodically rotating to help ensure that Board membership in maintaining reserves. According to product through their reserve inventory. reflects the interests of its constituency. the record, these costs include the cost It would be difficult to estimate such All qualified handlers, regardless of of storage, which can be in the range of costs because they would vary size, will continue to be able to $.01 per pound per month. Handlers depending upon each handler’s participate in the nomination and also incur costs associated with tracking operation. To the extent costs would be election process. The process would their own inventory levels. Witnesses increased, they would be proportionate continue to allow for both small and

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large handlers to be represented on the districts entitled to one Board seat when necessary in the future, they would be Board. the order was initially promulgated. submitted to OMB for approval. However, districts that are entitled to As with all Federal marketing order Amendment 5—Revision of Board one Board seat have changed over time programs, reports and forms are Membership Affiliation Requirements due to shifts in production. Amending periodically reviewed to reduce This amendment would revise §§ 930.23(b)(5) and (c)(4) by removing information requirements and § 930.20 to allow more than one Board the specific references to Districts 5, 6, duplication by industry and public member to be affiliated with the same 8, and 9 and replacing it with generic sector agencies. sales constituency from the same language to cover any district that is AMS is committed to complying with district, if such a conflict cannot be entitled to only one Board the E-Government Act, to promote the avoided. representative based on the use of the Internet and other Currently, § 930.20 does not allow representative calculation established in information technologies to provide more than one Board member to be § 930.20 would update order language to increased opportunities for citizen affiliated with the same sales better reflect the constantly changing access to Government information and constituency from the same district tart cherry industry. services, and for other purposes. under any circumstances. The purpose This amendment updates order Civil Justice Reform of this provision is to prevent any one language to remove incorrect references sales constituency from having a to district representation in the event The amendments to Marketing Order controlling influence on Board issues production shifts occur. It has no 930 proposed herein have been and actions. However, a situation economic impact on handlers, growers, reviewed under Executive Order 12988, occurred in District 7, Utah, where this or any other entities. Civil Justice Reform. They are not particular provision of the order did not Interested persons were invited to intended to have retroactive effect. allow the district from having two The Act provides that administrative present evidence at the hearing on the representatives on the Board, as it was proceedings must be exhausted before probable regulatory and informational entitled to under § 930.20 (b) of the parties may file suit in court. Under impacts of the proposed amendments to order. In that situation, the only section 608c(15)(A) of the Act, any the order on small entities. The record candidates willing to serve on the Board handler subject to an order may file evidence is that some of the proposed from Utah were affiliated with the same with USDA a petition stating that the amendments may result in some sales constituency. Thus Utah was only order, any provision of the order, or any minimal cost increases while others will able, under the marketing order rules, to obligation imposed in connection with result in cost decreases. To the extent seat one of the two Board the order is not in accordance with law there are any cost increases, the benefits representatives it was entitled to. and request a modification of the order of the proposed changes are expected to The proposed amendment is designed or to be exempted therefrom. A handler outweigh the costs. In addition, changes to prevent this problem from occurring is afforded the opportunity for a hearing in costs as a result of these amendments in the future by allowing more than one on the petition. After the hearing, USDA would be proportional to the size of Board member affiliated with the same would rule on the petition. The Act businesses involved and would not sales constituency to represent a provides that the district court of the unduly or disproportionately impact district, if such a sales constituency United Sates in any district in which the small entities. The informational impact conflict cannot be avoided. The hearing handler is an inhabitant, or has his or of proposed amendments is addressed record is clear that the sales her principal place of business, has in the Paperwork Reduction Act constituency provision should not jurisdiction to review USDA’s ruling on discussion that follows. prevent a district from having its the petition, provided an action is filed allocated number of seats on the Board USDA has not identified any relevant no later than 20 days after the date of if there are eligible candidates willing to Federal rules that duplicate, overlap or the entry of the ruling. serve on the Board. conflict with this proposed rule. These This amendment is not expected to amendments are intended to improve Findings and Conclusions; Discussion have an economic impact on growers or the operation and administration of the of Exceptions handlers. It relates to representation on order to the benefit of the industry. The material issues, findings and the Board, and is intended to help A Board proposal to change the voting conclusions, rulings, and general ensure each area covered under the requirements necessary to approve a findings and determinations included in order has the opportunity to achieve its Board action is not being recommended the Recommended Decision set forth in allocated representation on the Board. for adoption. the May 12, 2009, issue of the Federal Register (74 FR 22112) are hereby Amendment 6—Update Order Paperwork Reduction Act approved and adopted subject to the Language To Accurately Reflect Grower Information collection requirements following additions and modifications. and Handler Participation in the for Part 930 are currently approved by Nomination and Election Process in the Office of Management and Budget Material Issue Number 1—Authority To Districts With Only One Board (OMB), under OMB Number 0581–0177, Change the Primary Reserve Capacity Representative Tart Cherries Grown in the States of Based on the briefs and exceptions This amendment to § 930.23 would Michigan, New York, Pennsylvania, filed, the findings and conclusions in revise and update order language to Oregon, Utah, Washington, and Material Issue Number 1 of the more accurately reflect grower and Wisconsin. Implementation of these Recommended Decision are amended by handler participation in the nomination amendments would not trigger any adding the following four paragraphs to and election process in districts with changes to those requirements. It is read as follows: only one Board representative. possible that a change to the reporting One exception to the Recommended Sections 930.23(b)(5) and (c)(4) requirements may occur in the future if Decision concerning Material Issue specifically reference Districts 5, 6, 8, the Board believes it would be necessary Number 1 was filed by a grower and and 9 in regard to the nomination and to assist in program compliance efforts. processor of tart cherries. The exception election process. Those were the Should any such changes become did not support amending the order to

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authorize changing the capacity of the This proposal would not establish a Two exceptions to the Recommended primary reserve pool through informal level at which reserves would be Decision were filed regarding Material rulemaking. The exception stated that released. Informal rulemaking would be Issue Number 4. One exception was when the order was promulgated, a 50 required to establish such a level. The filed on behalf of the Board and the million-pound limitation was Board would need to develop adequate other was filed by a tart cherry producer established for the primary reserve, and justification in any recommendation it and processor. that limitation was adequately justified would make to USDA to implement a The exception filed on behalf of the at the time. Conversely, the proposed regulation that would authorize release Board was opposed to the conclusion in amendment was not adequately justified of the reserve. The intent of the proposal the Recommended Decision to not adopt through documentation and economic is to provide additional flexibility in the amendment as proposed by the testimony. administering the reserve program, and Board. The proposal would have The proposed amendment in itself could also reduce costs associated with changed the voting requirements would not make a change to the reserve tracking small amounts of reserve necessary for the Board to pass any capacity. It would change the process by product. The record evidence indicates action from two-thirds of the entire which a change to the reserve capacity that these objectives may be achieved if Board membership to two-thirds of the could be made. Under the proposed the proposed amendment is adopted. members present at a meeting. amendment, such a change could be For these reasons, the exception is According to the exception, the made through the informal rulemaking denied. stringent voting requirement was process rather than the formal originally implemented because of a Material Issue Number 3— perception that an entity or entities or rulemaking process that is currently Establishment of a Minimum Age required. any particular dominant district in Limitation on Product Placed Into terms of representation on the Board The hearing record supports that Reserves circumstances and conditions in the may otherwise have too large an industry change over time which could Based on the briefs and exceptions influence on Board actions. The warrant a change in the reserve filed, the findings and conclusions in exception stated that due to changes in capacity. If the proposed amendment is Material Issue Number 3 of the industry structure, there is no longer a dominant entity or district in terms of adopted and such circumstances occur, Recommended Decision are amended by Board representation, and a relaxation a change could be made through adding the following three paragraphs to of the voting requirements would thus informal rulemaking. During that read as follows: be appropriate. In addition, the process, the Board would recommend a One exception to the Recommended exception stated that experience under change to USDA, and only if the Decision concerning Material Issue the order has shown no evidence of recommendation was accompanied by Number 3 was filed by a grower and control over the Board by any entity or adequate justification would USDA processor of tart cherries. The exception region, and based on current industry proceed with the change. stated that the age of fruit placed in demographics, no entity or region could reserves is not truly a regulation of fruit The record supports allowing a gain such control. Finally, the exception quality, and that handlers should be change to the reserve capacity to be states that safeguards exist under the able to place whatever product they made through informal rulemaking order to protect the concerns of industry choose in the reserve. The exception rather than formal rulemaking. Thus, members against being adversely states that handlers could still place the exception concerning Material Issue affected if the proposed changes to the poor quality product in reserves if the Number 1 is denied. voting requirements were adopted. amendment is adopted. Material Issue Number 2—Authority To As stated in the Recommended According to the record evidence, the Establish a Minimum Level at Which Decision, the super-majority voting intent of this proposed amendment is to Reserves Would Be Released requirements were incorporated into the help maintain marketable products in order to help ensure a high degree of Based on the briefs and exceptions the reserve. When reserves are support for issues at the Board level. filed, the findings and conclusions in ultimately released, they need to be in These requirements were included in Material Issue Number 2 of the a condition to satisfy market demands. the order to help ensure minority Recommended Decision are amended by While placing an age limitation on interests were addressed and that the adding the following two paragraphs to reserve products does not guarantee a industry majority supported Board read as follows: specific level of quality, the record actions. These fundamentals are still One exception to the Recommended shows that product quality deteriorates relevant today. While it may be true that Decision concerning Material Issue over time. Placing an age limitation on the industry demographics have Number 2 was filed by a grower and product held in reserves will reduce the changed since the order was processor of tart cherries. The exception likelihood that product of a deteriorated promulgated, this does not establish a did not support amending the order to quality will be carried in handlers’ foundation that the current voting authorize establishing a minimum level reserve inventories. Based on the record requirements are not working properly at which cherries in the reserve would evidence, the proposed amendment and should be changed. The record be released. The exception indicated should be implemented and the evidence does not show that the current that adequate justification for the exception is therefore denied. voting requirements are having a proposed amendment was not provided. Material Issue Number 4—Voting negative impact on Board actions or the It further states that the Board did not Requirements Board’s ability to conduct business. present a reasonable definition of what The other exception regarding the minimum level would be in order Based upon the briefs and exceptions Material Issue Number 4 expressed for the reserves to be released. The filed, the findings and conclusions in support for the determination in the exception suggested that actual criteria Material Issue Number 4 of the Recommended Decision not to for establishing a minimum level should Recommended Decision are amended by implement the proposed amendment. be developed and incorporated into the adding the following five paragraphs to The record supports leaving the proposed amendment. read as follows: current voting requirements under the

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order in place, and the exception provisions added in the Recommended would relieve those handlers that do not advocating a change to the Decision regarding not applying the five present a sales constituency conflict Recommended Decision by adopting percent support requirement in certain from the five percent support Material Issue Number 4 is therefore instances. These exceptions stated that requirements. This would provide denied. the five percent support requirement opportunity to avoid a sales should apply in all situations, regardless constituency conflict among Board Material Issue Number 6—Revising of potential sales constituency conflicts. members if the handler without a sales Board Membership Affiliation According to these exceptions, having constituency conflict were to win the Requirements support from handlers with a minimum election. In addition, this requirement Based upon the briefs and exceptions of five percent of the volume of cherries would be the same in all districts. filed, the findings and conclusions in handled in the district requirement is Although it currently appears to be an Material Issue Number 6 of the more important than avoiding a issue only in Utah at this time, as the Recommended Decision are amended by potential sales constituency conflict. record indicates and the exceptions adding the following eight paragraphs to These exceptions further state that note, changes and affiliations in the read as follows: avoiding a sales constituency conflict is industry occur over time. It could Six exceptions concerning Material not as big an issue now as it was when possibly be an issue in another district Issue Number 6 were received. Five of the order was promulgated because the in the future, and if so, it would be the exceptions were from tart cherry structure of the industry has changed applied the same in all instances. growers and processors, and one was and one sales constituency could no In order to address the issues raised from the Board. longer gain control of the Board. The as a result of the interaction of the Five of the exceptions expressed exceptions also state that this provisions in proposals in Material concerns with the interaction of amendment should not apply in one Issue Numbers 5 and 6, and to maintain Material Issue Number 6 and Material District but not another. an open election process that allows all Issue Number 5 as these two issues were One exception expressed the view qualified handler candidates to discussed in the Recommended that the proposed amendment to revise participate, USDA believes the proposed Decision. The amendment proposed by Board membership affiliation provisions as presented in the the Board and discussed in Material requirements to allow more than one Recommended Decision are appropriate. Issue Number 5 of the Recommended Board member per district to be from The exceptions are therefore denied. Decision would revise Board the same sales constituency if it cannot membership nomination procedures. be avoided, should only apply in Rulings on Exceptions The amendment would require a situations that are identical to those In arriving at the findings and handler to receive support from currently prevailing in Utah. In Utah, a conclusions and the regulatory handler(s) that handled at least five situation occurred where there were no provisions of this decision, the percent of the average production of tart candidates from a different sales exceptions to the Recommended cherries in the applicable district in constituency that were willing to serve Decision were carefully considered in order to be eligible to participate as a on the Board. Consequently, Utah conjunction with the record evidence. candidate in an election for Board (District 7) was unable to fill a Board To the extent that the findings and membership. The proposed amendment position for a period of time. conclusions and the regulatory would also require a handler to receive One of the exceptions indicated that provisions of this decision are at support from handler(s) that handled at if the five percent support requirement variance with the exceptions, such least five percent of the average was not applied in certain instances, it exceptions are denied. production of tart cherries in the would preclude other handler applicable district in order to be elected candidates from seeking nomination Marketing Agreement and Order by the industry and recommended to and election if their election would Annexed hereto and made a part the Secretary for selection to the Board. present a sales constituency conflict. hereof is the document entitled ‘‘Order The amendment proposed by the Board The Recommended Decision took into Amending the Order Regulating the and discussed in Material Issue Number account both the merits of the proposed Handling of Tart Cherries Grown in the 6 of the Recommended Decision would amendment requiring Board candidates States of Michigan, New York, revise Board membership affiliation to receive support from handlers Pennsylvania, Oregon, Utah, requirements to allow more than one handling at least five percent of the Washington, and Wisconsin.’’ This Board member per district to be volume in the District to be nominated document has been decided upon as the affiliated with the same sales and elected to the Board and also the detailed and appropriate means of constituency if it cannot be avoided. merits of the proposed amendment to effectuating the foregoing findings and The Recommended Decision included allow a sales constituency conflict to conclusions. adding a provision to the proposal in exist in Board membership if such a It is hereby ordered, that this entire Material Issue Number 5 to conform to situation cannot be avoided, in the decision be published in the Federal the proposed amendment to § 930.20 (g). interest of each District achieving its Register. The added provision would not apply allocated representation on the Board. the five percent support requirement for The added provision in Material Issue Referendum Order Board membership candidates in Number 5 recognizes the importance of It is hereby directed that a referendum instances where such a requirement both issues. The changes would not be conducted in accordance with the would result in a sales constituency preclude any qualified handler from procedure for the conduct of referenda conflict. (A sales constituency conflict is seeking his or her candidacy for (7 CFR part 900.400–407) to determine considered to exist if two persons from nomination or election to the Board. whether the annexed order amending the same district are affiliated with the Any qualified handler would be able to the order regulating the handling of tart same sales constituency.) seek a Board position, including those cherries grown in the States of The five exceptions that expressed who may present a sales constituency Michigan, New York, Pennsylvania, concern with the interaction of Material conflict with an existing Board member. Oregon, Utah, Washington, and Issues 5 and 6 were opposed to the The effect of the changes to the proposal Wisconsin is approved or favored by

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growers and processors, as defined Washington, and Wisconsin. Upon the PART 930—TART CHERRIES GROWN under the terms of the order, who basis of the evidence introduced at such IN THE STATES OF MICHIGAN, NEW during the representative period were hearing and the record thereof, it is YORK, PENNSYLVANIA, OREGON, engaged in the production or processing found that: UTAH, WASHINGTON, AND of tart cherries in the production area. (1) The marketing agreement and WISCONSIN The representative period for the order, as amended, and as hereby conduct of such referendum is hereby proposed to be further amended, and all 1. The authority citation for 7 CFR determined to be July 1, 2008 through of the terms and conditions thereof, part 930 continues to read as follows: June 30, 2009. would tend to effectuate the declared Authority: 7 U.S.C. 601–674. The agents of the Secretary to conduct policy of the Act; 2. Revise paragraph (g) of § 930.20 to such referendum are hereby designated (2) The marketing agreement and read as follows: to be Kenneth G. Johnson and Patricia order, as amended, and as hereby A. Petrella, Marketing Order proposed to be further amended, § 930.20 Establishment and Membership. Administration Branch, Fruit and regulate the handling of tart cherries * * * * * Vegetable Programs, AMS, USDA, Suite grown in the production area in the (g) In order to achieve a fair and 2A04, Unit 155, 4700 River Road, same manner as, and are applicable only balanced representation on the Board, Riverdale, MD 20737; telephone: (301) to, persons in the respective classes of and to prevent any one sales 734–5243, Fax: (301) 734–5275; E-mail commercial and industrial activity constituency from gaining control of the [email protected] or specified in the marketing agreement Board, not more than one Board member [email protected]. and order upon which a hearing has may be from, or affiliated with, a single List of Subjects in 7 CFR Part 930 been held; sales constituency in those districts (3) The marketing agreement and having more than one seat on the Board; Marketing agreements, Reporting and order, as amended, and as hereby Provided, That this prohibition shall not recordkeeping requirements, Tart proposed to be further amended, are apply in a district where such a conflict cherries. limited in their application to the cannot be avoided. There is no Dated: January 6, 2010. smallest regional production area which prohibition on the number of Board David R. Shipman, is practicable, consistent with carrying members from differing districts that Acting Administrator, Agricultural Marketing out the declared policy of the Act, and may be elected from a single sales Service. the issuance of several orders applicable constituency which may have Order Amending the Order Regulating to subdivisions of the production area operations in more than one district. the Handling of Tart Cherries Grown in would not effectively carry out the However, as provided in § 930.23, a Michigan, New York, Pennsylvania, declared policy of the Act; handler or grower may only nominate Oregon, Utah, Washington, and (4) The marketing agreement and Board members and vote in one district. Wisconsin 1 order, as amended, and as hereby * * * * * proposed to be further amended, 3. In § 930.23 revise paragraphs (b)(2) Findings and Determinations prescribe, insofar as practicable, such and (b)(5), redesignate paragraph (c)(3) The findings and determinations different terms applicable to different as paragraph (c)(3)(i), add a new hereinafter set forth are supplementary parts of the production area as are paragraph (c)(3)(ii), and revise to the findings and determinations that necessary to give due recognition to the paragraph (c)(4) to read as follows: were previously made in connection differences in the production and with the issuance of the marketing marketing of tart cherries grown in the § 930.23 Nomination and Election. agreement and order; and all said production area; and * * * * * previous findings and determinations (5) All handling of tart cherries grown (b) * * * are hereby ratified and affirmed, except in the production area as defined in the (2) In order for the name of a handler insofar as such findings and marketing agreement and order is in the nominee to appear on an election ballot, determinations may be in conflict with current of interstate or foreign the nominee’s name must be submitted the findings and determinations set commerce or directly burdens, with a petition form, to be supplied by forth herein. obstructs, or affects such commerce. the Secretary or the Board, which contains the signature of one or more (a) Findings and Determinations Upon Order Relative to Handling handler(s), other than the nominee, from the Basis of the Hearing Record It is therefore ordered, That on and the nominee’s district who is or are Pursuant to the provisions of the after the effective date hereof, all eligible to vote in the election and that Agricultural Marketing Agreement Act handling of tart cherries grown in handle(s) a combined total of no less of 1937, as amended, (7 U.S.C. 601– Michigan, New York, Pennsylvania, than five percent (5%) of the average 612), and the applicable rules of Oregon, Utah, Washington, and production, as that term is used practice and procedure effective Wisconsin shall be in conformity to, and § 930.20, handled in the district. thereunder (7 CFR part 900), a public in compliance with the terms and Provided, that this requirement shall not hearing was held upon proposed conditions of the said order as hereby apply if its application would result in amendment of Marketing Agreement proposed to be amended as follows: a sales constituency conflict as provided and Order No. 930 (7 CFR part 930), The provisions of the proposed in § 930.20(g). The requirement that the regulating the handling of tart cherries marketing agreement and order petition form be signed by a handler grown in Michigan, New York, amending the order contained in the other than the nominee shall not apply Pennsylvania, Oregon, Utah, Recommended Decision issued on May in any district where fewer than two 7, 2009, and published in the Federal handlers are eligible to vote. 1 This order shall not become effective unless and Register on May 12, 2009, will be and * * * * * until the requirements of § 900.14 of the rules of practice and procedure governing proceedings to are the terms and provisions of this (5) In districts entitled to only one formulate marketing agreements and marketing order amending the order and are set Board member, both growers and orders have been met. forth in full herein. handlers may be nominated for the

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district’s Board seat. Grower and reserve and will be regulated DEPARTMENT OF TRANSPORTATION handler nominations must follow the accordingly. Federal Aviation Administration petition procedures outlined in * * * * * paragraphs (b)(1) and (b)(2) of this section. 5. Add a new paragraph (d) to 14 CFR Part 39 § 930.54 to read as follows: * * * * * [Docket No. FAA–2010–0027; Directorate (c) * * * § 930.54 Prohibition on the use or Identifier 2008–NM–204–AD] disposition of inventory reserve cherries. (3)(i) * * * RIN 2120–AA64 * * * * * (ii) To be seated as a handler Airworthiness Directives; Sicma Aero (d) Should the volume of cherries representative in any district, the Seat 9140, 9166, 9173, 9174, 9184, held in the primary inventory reserves successful candidate must receive the 9188, 9196, 91B7, 91B8, 91C0, 91C2, and, subsequently, the secondary support of handler(s) that handled a 91C3, 91C4, 91C5, and 9301 Series combined total of no less than five inventory reserves reach a minimum Passenger Seat Assemblies; and percent (5%), of the average production, amount, which level will be established Sicma Aero Seat 9501311–05, as that term is used in § 930.20, handled by the Secretary upon recommendation 9501301–06, 9501311–15, 9501301–16, in the district; Provided, that this from the Board, the products held in the 9501441–30, 9501441–33, 9501311–55, paragraph shall not apply if its respective reserves shall be released 9501301–56, 9501441–83, 9501441–95, application would result in a sales from the reserves and made available to 9501311–97, and 9501301–98 constituency conflict as provided in the handlers as free tonnage. Passenger Seat Assemblies; Installed § 930.20(g). 6. Revise paragraph (b) of § 930.55 to on Various Transport Category (4) In districts entitled to only one read as follows: Airplanes Board member, growers and handlers AGENCY: may vote for either the grower or § 930.55 Primary inventory reserves. Federal Aviation Administration (FAA), DOT. handler nominee(s) for the single seat * * * * * allocated to those districts. ACTION: Notice of proposed rulemaking (b) The form of the cherries, frozen, (NPRM). * * * * * canned in any form, dried, or 4. Revise paragraph (i) of § 930.50 to concentrated juice, placed in the SUMMARY: We propose to adopt a new read as follows: primary inventory reserve is at the airworthiness directive (AD) for the option of the handler. The product(s) products listed above. This proposed § 930.50 Marketing policy. placed by the handler in the primary AD results from mandatory continuing * * * * * inventory reserve must have been airworthiness information (MCAI) (i) Restricted Percentages. Restricted produced in either the current or the originated by an aviation authority of percentage requirements established preceding two crop years. Except as may another country to identify and correct under paragraphs (b), (c), or (d) of this be limited by § 930.50(i) or as may be an unsafe condition on an aviation section may be fulfilled by handlers by permitted pursuant to §§ 930.59 and product. The MCAI describes the unsafe either establishing an inventory reserve 930.62, such inventory reserve portion condition as: Cracks have been found on seat backrest links P/N (part number) in accordance with § 930.55 or § 930.57 shall be equal to the sum of the products 90–000200–104–1 and 90–000200–104– or by diversion of product in accordance obtained by multiplying the weight or 2. These cracks can significantly affect with § 930.59. In years where required, volume of the cherries in each lot of the Board shall establish a maximum the structural integrity of seat backrests. cherries acquired during the fiscal Failure of the backrest links could result percentage of the restricted quantity period by the then effective restricted which may be established as a primary in injury to an occupant during percentage fixed by the Secretary; emergency landing conditions. The inventory reserve such that the total Provided, That in converting cherries in primary inventory reserve does not proposed AD would require actions that each lot to the form chosen by the exceed 50-million pounds; Provided, are intended to address the unsafe handler, the inventory reserve That such 50-million-pound quantity condition described in the MCAI. obligations shall be adjusted in may be changed upon recommendation DATES: We must receive comments on of the Board and approval of the accordance with uniform rules adopted this proposed AD by March 1, 2010. by the Board in terms of raw fruit Secretary. Any such change shall be ADDRESSES: You may send comments by recommended by the Board on or before equivalent. any of the following methods: September 30 of any crop year to * * * * * • Federal eRulemaking Portal: Go to become effective for the following crop [FR Doc. 2010–315 Filed 1–12–10; 8:45 am] http://www.regulations.gov. Follow the year, and the quantity may be changed BILLING CODE 3410–02–P instructions for submitting comments. no more than one time per crop year. • Fax: (202) 493–2251. Handlers will be permitted to divert (at • Mail: U.S. Department of plant or with grower diversion Transportation, Docket Operations, M– certificates) as much of the restricted 30, West Building Ground Floor, Room percentage requirement as they deem W12–140, 1200 New Jersey Avenue, SE., appropriate, but may not establish a Washington, DC 20590. primary inventory reserve in excess of • Hand Delivery: U.S. Department of the percentage established by the Board Transportation, Docket Operations, M– for restricted cherries. In the event 30, West Building Ground Floor, Room handlers wish to establish inventory W12–40, 1200 New Jersey Avenue, SE., reserve in excess of this amount, they Washington, DC, between 9 a.m. and 5 may do so, in which case it will be p.m., Monday through Friday, except classified as a secondary inventory Federal holidays.

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For service information identified in personal information you provide. We general, agree with their substance. But this proposed AD, contact Sicma Aero will also post a report summarizing each we might have found it necessary to use Seat, 7, Rue Lucien Coupet, 36100 substantive verbal contact we receive different words from those in the MCAI ISSOUDUN, France; telephone +33 (0) 2 about this proposed AD. to ensure the AD is clear for U.S. 54 03 39 39; fax +33 (0) 2 54 03 39 00; operators and is enforceable. In making Discussion e-mail: these changes, we do not intend to differ [email protected]; The Direction Ge´ne´rale de l’Aviation substantively from the information Internet http://www.sicma.zodiac.com/ Civile (DGAC), which is the provided in the MCAI and related en/. You may review copies of the airworthiness authority for France, has service information. referenced service information at the issued French Airworthiness Directive We might also have proposed FAA, Transport Airplane Directorate, 2001–605(AB), dated December 12, 2001 different actions in this AD from those 1601 Lind Avenue, SW., Renton, (referred to after this as ‘‘the MCAI’’), to in the MCAI in order to follow FAA Washington. For information on the correct an unsafe condition for the policies. Any such differences are availability of this material at the FAA, specified products. The MCAI states: highlighted in a NOTE within the call 425–227–1221 or 425–227–1152. Cracks have been found on seat backrest proposed AD. links P/N (part number) 90–000200–104–1 Costs of Compliance Examining the AD Docket and 90–000200–104–2. These cracks can You may examine the AD docket on significantly affect the structural integrity of Based on the service information, we the Internet at http:// seat backrests. Therefore a life limit is estimate that this proposed AD would www.regulations.gov; or in person at the introduced on the links. On 9g seats also affect 70,073 seats on 163 products of affected by this problem, stronger unlimited Docket Operations office between 9 a.m. U.S. registry. We also estimate that it life limits have been developed and their would take 1 work-hour per seat to and 5 p.m., Monday through Friday, installation has been rendered mandatory. except Federal holidays. The AD docket However, on 16g seats the affected links have comply with the basic requirements of contains this proposed AD, the a direct influence on certification dynamic this proposed AD. The average labor regulatory evaluation, any comments tests and cannot be replaced by similar rate is $80 per work-hour. Required received, and other information. The stronger links without performing again all parts would cost about $0 per seat. street address for the Docket Operations dynamic tests for each seat part number. Where the service information lists office (telephone (800) 647–5527) is in Failure of the backrest links could result required parts costs that are covered the ADDRESSES section. Comments will in injury to an occupant during under warranty, we have assumed that be available in the AD docket shortly emergency landing conditions. The there will be no charge for these costs. after receipt. required actions include a general visual As we do not control warranty coverage FOR FURTHER INFORMATION CONTACT: inspection for cracking of backrest links, for affected parties, some parties may Jeffrey Lee, Aerospace Engineer, Boston replacement with new links if cracking incur costs higher than estimated here. Aircraft Certification Office, FAA, is found, and eventual replacement of Based on these figures, we estimate the Engine & Propeller Directorate, 12 New all links with new links. cost of the proposed AD on U.S. England Executive Park, Burlington, MA You may obtain further information operators to be $5,605,840, or $80 per 01803; telephone (781) 238–7161; fax by examining the MCAI in the AD seat. (781) 238–7170. docket. Authority for This Rulemaking SUPPLEMENTARY INFORMATION: Relevant Service Information Title 49 of the United States Code Comments Invited Sicma Aero Seat has issued Service specifies the FAA’s authority to issue Bulletin 90–25–012, Issue 4, dated rules on aviation safety. Subtitle I, We invite you to send any written December 19, 2001, including Annex 1, section 106, describes the authority of relevant data, views, or arguments about Issue 1, dated July 9, 2001. The actions the FAA Administrator. ‘‘Subtitle VII: this proposed AD. Send your comments described in this service information are Aviation Programs,’’ describes in more to an address listed under the intended to correct the unsafe condition detail the scope of the Agency’s ADDRESSES section. Include ‘‘Docket No. identified in the MCAI. authority. FAA–2010–0027; Directorate Identifier We are issuing this rulemaking under 2008–NM–204–AD’’ at the beginning of FAA’s Determination and Requirements the authority described in ‘‘Subtitle VII, your comments. We specifically invite of This Proposed AD Part A, Subpart III, Section 44701: comments on the overall regulatory, This product has been approved by General requirements.’’ Under that economic, environmental, and energy the aviation authority of another section, Congress charges the FAA with aspects of this proposed AD. We will country, and is approved for operation promoting safe flight of civil aircraft in consider all comments received by the in the United States. Pursuant to our air commerce by prescribing regulations closing date and may amend this bilateral agreement with the State of for practices, methods, and procedures proposed AD based on those comments. Design Authority, we have been notified the Administrator finds necessary for We have lengthened the 30-day of the unsafe condition described in the safety in air commerce. This regulation comment period for proposed ADs that MCAI and service information is within the scope of that authority address MCAI originated by aviation referenced above. We are proposing this because it addresses an unsafe condition authorities of other countries to provide AD because we evaluated all pertinent that is likely to exist or develop on adequate time for interested parties to information and determined an unsafe products identified in this rulemaking submit comments. The comment period condition exists and is likely to exist or action. for these proposed ADs is now typically develop on other products of the same Regulatory Findings 45 days, which is consistent with the type design. comment period for domestic transport We determined that this proposed AD ADs. Differences Between This AD and the would not have federalism implications We will post all comments we MCAI or Service Information under Executive Order 13132. This receive, without change, to http:// We have reviewed the MCAI and proposed AD would not have a www.regulations.gov, including any related service information and, in substantial direct effect on the States, on

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the relationship between the national TABLE 1—CERTAIN AFFECTED MODELS (2) If, during the inspection required by Government and the States, or on the paragraph (f)(1) of this AD, cracking is found distribution of power and Manufacturer Model between the side of the backrest link and the responsibilities among the various lock-out pin hole but the cracking does not Airbus ...... A330–200 and –300 Series pass this lock-out pin hole (refer to Figure 2 levels of government. of Sicma Aero Seat Service Bulletin 90–25– For the reasons discussed above, I Airplanes. Airbus ...... A340–200, –300, –500 and 012, Issue 4, dated December 19, 2001): certify this proposed regulation: –600 Series Airplanes. Within 600 flight hours or 3 months after 1. Is not a ‘‘significant regulatory The Boeing 777–200, –300, –300ER, doing the inspection, whichever occurs first, action’’ under Executive Order 12866; Company. and –200LR Series Air- replace both backrest links of the affected 2. Is not a ‘‘significant rule’’ under the planes. seat with new backrest links having the same DOT Regulatory Policies and Procedures part number (P/N 90–000200–104–1 or 90–000200–104– (44 FR 11034, February 26, 1979); and Note 1: This AD applies to Sicma Aero Seat 3. Will not have a significant 2), in accordance with Part Two passenger seat assemblies as installed on any ‘‘Replacement Procedure’’ of Sicma Aero Seat economic impact, positive or negative, airplane, regardless of whether the airplane Service Bulletin 90–25–012, Issue 4, dated on a substantial number of small entities has been otherwise modified, altered, or December 19, 2001. under the criteria of the Regulatory repaired in the area subject to the (3) If, during the inspection required by Flexibility Act. requirements of this AD. For airplanes that paragraph (f)(1) of this AD, cracking is found We prepared a regulatory evaluation have been modified, altered, or repaired so that passes beyond the lock-out pin hole of the estimated costs to comply with that the performance of the requirements of (refer to Figure 2 of Sicma Aero Seat Service this AD is affected, the owner/operator must Bulletin 90–25–012, Issue 4, dated December this proposed AD and placed it in the request approval for an alternative method of AD docket. 19, 2001): Before further flight, replace both compliance according to paragraph (g)(1) of backrest links of the affected seat with new List of Subjects in 14 CFR Part 39 this AD. The request should include an backrest links having the same part numbers assessment of the effect of the modification, (P/N 90–000200–104–1 or 90–000200–104– Air transportation, Aircraft, Aviation alteration, or repair on the unsafe condition 2), in accordance with Part Two safety, Incorporation by reference, addressed by this AD; and, if the unsafe ‘‘Replacement Procedure’’ of Sicma Aero Seat Safety. condition has not been eliminated, the Service Bulletin 90–25–012, Issue 4, dated request should include specific proposed December 19, 2001. The Proposed Amendment actions to address it. (4) If no cracking is found during the Accordingly, under the authority Subject inspection required by paragraph (f)(1) of this delegated to me by the Administrator, AD: At the later of the times specified in (d) Air Transport Association (ATA) of paragraphs (f)(4)(i) and (f)(4)(ii) of this AD, the FAA proposes to amend 14 CFR part America Code 25: Equipment/Furnishings. 39 as follows: replace the links, P/Ns 90–000200–104–1 and Reason 90–000200–104–2, with new backrest links PART 39—AIRWORTHINESS having the same part numbers (P/N 90– (e) The mandatory continuing 000200–104–1 or 90–000200–104–2), in DIRECTIVES airworthiness information (MCAI) states: accordance with Part Two ‘‘Replacement Cracks have been found on seat backrest Procedure’’ of Sicma Aero Seat Service 1. The authority citation for part 39 links P/Ns (part numbers) 90–000200–104–1 continues to read as follows: Bulletin 90–25–012, Issue 4, dated December and 90–000200–104–2. These cracks can 19, 2001. Authority: 49 U.S.C. 106(g), 40113, 44701. significantly affect the structural integrity of (i) Before 12,000 flight hours on the seat backrests. Therefore a life limit is backrest links, P/Ns 90–000200–104–1 and § 39.13 [Amended] introduced on the links. On 9g seats also 90–000200–104–2, since new. 2. The FAA amends § 39.13 by adding affected by this problem, stronger unlimited (ii) Within 900 flight hours or 5 months life limits have been developed and their the following new AD: after the effective date of this AD, whichever installation has been rendered mandatory. occurs later. Sicma Aero Seat: Docket No. FAA–2010– However, on 16g seats the affected links have (5) Actions done before the effective date 0027; Directorate Identifier 2008–NM– a direct influence on certification dynamic of this AD in accordance with Sicma Aero 204–AD. tests and cannot be replaced by similar Seat Service Bulletin 90–25–012, Issue 3, stronger links without performing again all dated October 3, 2001, are acceptable for Comments Due Date dynamic tests for each seat part number. compliance with the corresponding actions (a) We must receive comments by March 1, Failure of the backrest links could result in of this AD. 2010. injury to an occupant during emergency landing conditions. The required actions Affected ADs FAA AD Differences include a general visual inspection for (b) None. cracking of backrest links, replacement with Note 2: This AD differs from the MCAI and/or service information as follows: The Applicability new links if cracking is found, and eventual replacement of all links with new links. MCAI specifies doing repetitive inspections (c) This AD applies to Sicma Aero Seat for cracking of links having over 12,000 flight 9140, 9166, 9173, 9174, 9184, 9188, 9196, Actions and Compliance hours since new until the replacement of the 91B7, 91B8, 91C0, 91C2, 91C3, 91C4, 91C5, (f) Unless already done, do the following link is done. This AD does not include those and 9301 series passenger seat assemblies; actions. repetitive inspections because we have and Sicma Aero Seat 9501311–05, 9501301– (1) At the later of the times specified in reduced the required time for replacing those 06, 9501311–15, 9501301–16, 9501441–30, paragraphs (f)(1)(i) and (f)(1)(ii) of this AD, links. This AD requires replacement of the 9501441–33, 9501311–55, 9501301–56, do a general visual inspection for cracking of link before 12,000 flight hours since new, or 9501441–83, 9501441–95, 9501311–97, and the backrest links, P/Ns 90–000200–104–1 within 900 flight hours or 5 months of the 9501301–98 passenger seat assemblies; and 90–000200–104–2, in accordance with effective date of this AD, whichever occurs identified in Annex 1, Issue 1, dated July 9, Part One ‘‘Checking Procedure’’ of Sicma later. 2001, of Sicma Aero Seat Service Bulletin Aero Seat Service Bulletin 90–25–012, Issue 90–25–012, Issue 4, dated December 19, 4, dated December 19, 2001: Other FAA AD Provisions 2001; that have backrest links part numbers (i) Before 6,000 flight hours on the backrest (g) The following provisions also apply to (P/Ns) 90–000200–104–1 and 90–000200– link since new. this AD: 104–2; and that are installed on, but not (ii) Within 900 flight hours or 5 months (1) Alternative Methods of Compliance limited to the airplanes identified in Table 1 after the effective date of this AD, whichever (AMOCs): The Manager, Boston Aircraft of this AD, certificated in any category. occurs later. Certification Office, FAA, has the authority to

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approve AMOCs for this AD, if requested Federal Trade Commission, answered. For all comments submitted, using the procedures found in 14 CFR 39.19. Washington, D.C. 20580. please provide any relevant data, Send information to ATTN: Jeffrey Lee, DATES: Written comments must be statistics, or any other evidence, upon Aerospace Engineer, Boston Aircraft which those comments are based. Certification Office, FAA, Engine & Propeller received by March 1, 2010. Directorate, 12 New England Executive Park, ADDRESSES: Interested parties are 1. Please provide comments on any or Burlington, MA 01803; telephone (781) 238– invited to submit written comments all of the provisions in the proposed 7161; fax (781) 238–7170. Before using any electronically or in paper form, by guidelines. For each provision approved AMOC on any airplane to which following the instructions in the commented on please describe (a) the the AMOC applies, notify your principal Invitation To Comment part of the impact of the provision(s) (including maintenance inspector (PMI) or principal SUPPLEMENTARY INFORMATION section any benefits and costs), if any, and (b) avionics inspector (PAI), as appropriate, or what alternatives, if any, iSAFE should lacking a principal inspector, your local below. Comments in electronic form Flight Standards District Office. should be submitted by using the consider, as well as the costs and (2) Airworthy Product: For any requirement following weblink: (https:// benefits of those alternatives. in this AD to obtain corrective actions from public.commentworks.com/ftc/ 2. Do the provisions of the proposed a manufacturer or other source, use these iSAFEsafeharbor) (and following the guidelines governing operators’ actions if they are FAA-approved. Corrective instructions on the web-based form). information practices provide ‘‘the same actions are considered FAA-approved if they Comments in paper form should be or greater protections for children’’ as are approved by the State of Design Authority mailed or delivered to the following those contained in Sections 312.2-312.8 (or their delegated agent). You are required address: Federal Trade Commission, of the Rule?4 Where possible, please cite to assure the product is airworthy before it is returned to service. Office of the Secretary, Room H-135 the relevant sections of both the Rule (3) Reporting Requirements: For any (Annex E), 600 Pennsylvania Avenue, and the proposed guidelines. reporting requirement in this AD, under the NW, Washington, DC 20580, (202) 326- 3. Are the mechanisms used to assess provisions of the Paperwork Reduction Act 2252. operators’ compliance with the (44 U.S.C. 3501 et seq.), the Office of SUPPLEMENTARY INFORMATION: guidelines effective?5 If not, please Management and Budget (OMB) has Section A. Background describe (a) how the proposed approved the information collection guidelines could be modified to satisfy requirements and has assigned OMB Control On October 20, 1999, the Commission Number 2120–0056. the Rule’s requirements, and (b) the issued its final Rule1 pursuant to the costs and benefits of those Related Information Children’s Online Privacy Protection modifications. (h) Refer to MCAI French Airworthiness Act, 15 U.S.C. 6501, et seq, which 4. Are the incentives for operators’ 2 Directive 2001–605(AB), dated December 12, became effective on April 21, 2000. compliance with the guidelines 2001, and Sicma Aero Seat Service Bulletin The Rule requires certain website effective?6 If not, please describe (a) 90–25–012, Issue 4, dated December 19, operators to post privacy policies, how the proposed guidelines could be 2001, including Annex 1, Issue 1, dated July provide notice, and obtain parental 9, 2001, for related information. modified to satisfy the Rule’s consent prior to collecting, using, or requirements, and (b) the costs and Issued in Renton, Washington, on January disclosing personal information from benefits of those modifications. 5, 2010. ‘‘ children. The Rule contains a safe 5. Do the guidelines provide adequate Ali Bahrami, ’’ harbor provision enabling industry means for resolving consumer Manager, Transport Airplane Directorate, groups or others to submit to the complaints? If not, please describe (a) Aircraft Certification Service. Commission for approval self-regulatory how the proposed guidelines could be [FR Doc. 2010–484 Filed 1–12–10; 8:45 am] guidelines that would implement the 3 modified to resolve consumer BILLING CODE 4910–13–P Rule’s protections. complaints adequately, and (b) the costs Pursuant to Section 312.10 of the and benefits of those modifications. Rule, iSAFE has submitted proposed FEDERAL TRADE COMMISSION self-regulatory guidelines to the Section C. Invitation to Comment Commission for approval. The full text All persons are hereby given notice of 16 CFR Part 312 of the proposed guidelines is available the opportunity to submit written data, on the Commission’s website, at Children’s Online Privacy Protection views, facts, and arguments addressing (www.ftc.gov/bcp/ the proposed self-regulatory guidelines. Rule Safe Harbor Proposed Self- isafesafeharborapplication.pdf). Regulatory Guidelines; i-SAFE, Inc. The Commission invites written Application for Safe Harbor Section B. Questions on the Proposed comments to assist it in ascertaining the Guidelines facts necessary to reach a determination AGENCY: Federal Trade Commission The Commission is seeking comment as to whether to approve the proposed (FTC or Commission) on various aspects of the proposed guidelines. Written comments must be ACTION: Notice announcing submission guidelines, and is particularly interested received on or before March 1, 2010, of proposed ‘‘safe harbor’’ guidelines and in receiving comment on the questions and may be submitted electronically or requesting public comment. that follow. These questions are in paper form. Comments should refer designed to assist the public and should to ‘‘iSAFE Safe Harbor Proposal, SUMMARY: The Federal Trade not be construed as a limitation on the P094504’’ to facilitate the organization of Commission publishes this notice and comments. Please note that your request for public comment concerning issues on which public comment may be submitted. Responses to these comment – including your name and proposed self-regulatory guidelines your state – will be placed on the public submitted by i-SAFE, Inc. under the safe questions should cite the numbers and subsection of the questions being record of this proceeding, including on harbor provision of the Children’s the publicly accessible FTC website, at Online Privacy Protection Rule. 1 64 FR 59888 (1999). FOR FURTHER INFORMATION CONTACT: 2 16 C.F.R. Part 312. 4 See 16 C.F.R. § 312.10(b)(1); 64 FR at 59915. Mamie Kresses, Attorney, (202) 326- 3 See 16 C.F.R. § 312.10; 64 FR at 59906-59908, 5 See 16 C.F.R. § 312.10(b)(2); 64 FR at 59915. 2070, Division of Advertising Practices, 59915. 6 See 16 C.F.R. § 312.10(b)(3); 64 FR at 59915.

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(http://www.ftc.gov/os/ (Annex E), 600 Pennsylvania Avenue, designated agents. These regulations publiccomments.shtm). NW, Washington, DC 20580. The FTC is also propose amendments to modify the Because comments will be made requesting that any comment filed in existing regulations under section 3504 public, they should not include any paper form be sent by courier or to be consistent with the organizational sensitive personal information, such as overnight service, if possible, because structure of the Internal Revenue any individual’s Social Security U.S. postal mail in the Washington area Service (IRS), and to update the citation number; date of birth; driver’s license and at the Commission is subject to to the Internal Revenue Code of 1986. number or other state identification delay due to heightened security DATES: Written or electronic comments number, or foreign country equivalent; precautions. must be received by April 13, 2010. passport number; financial account The FTC Act and other laws the ADDRESSES: Send submissions to: number; or credit or debit card number. Commission administers permit the CC:PA:LPD:PR (REG–137036–08), Room Comments also should not include any collection of public comments to 5203, Internal Revenue Service, POB sensitive health information, such as consider and use in this proceeding as 7604, Ben Franklin Station, Washington medical records or other individually appropriate. The Commission will DC 20044. Submissions may be hand identifiable health information. In consider all timely and responsive delivered Monday through Friday, addition, comments should not include public comments that it receives, between the hours of 8 a.m. and 4 p.m. any ‘‘[t]rade secret or any commercial or whether filed in paper or electronic to CC:PA:LPD:PR (REG–137036–08), financial information which is obtained form. Comments received will be Courier’s Desk, Internal Revenue from any person and which is privileged available to the public on the FTC Service, 1111 Constitution Avenue, or confidential...,’’ as provided in website, to the extent practicable, at NW., Washington, DC. Additionally, Section 6(f) of the Federal Trade (http://www.ftc.gov/os/ taxpayers may submit comments Commission Act (‘‘FTC Act’’), 15 U.S.C. publiccomments.shtm). As a matter of electronically via the Federal 46(f), and FTC Rule 4.10(a)(2), 16 CFR discretion, the Commission makes every eRulemaking Portal at http:// 4.10(a)(2). Comments containing effort to remove home contact www.regulations.gov. (Indicate IRS and material for which confidential information for individuals from the REG–137036–08.) treatment is requested must be filed in public comments it receives before FOR FURTHER INFORMATION CONTACT: paper form, must be clearly labeled placing those comments on the FTC Concerning the proposed regulations, ‘‘Confidential,’’ and must comply with Website. More information, including 7 contact Selvan Boominathan at (202) FTC Rule 4.9(c), 16 CFR 4.9(c). routine uses permitted by the Privacy 622–0047; concerning the submission of Because paper mail addressed to the Act may be found in the FTC’s privacy comments or requests for a hearing, FTC is subject to delay due to policy, at (http://www.ftc.gov/ftc/ contact Oluwafunmilayo (Funmi) heightened security screening, please privacy.shtm). Taylor, at (202) 622–7180 (not toll-free consider submitting your comments in By direction of the Commission. numbers). electronic form. Comments filed in electronic form should be submitted by Donald S. Clark SUPPLEMENTARY INFORMATION: using the following weblink: (https:// Secretary Background public.commentworks.com/ftc/ [FR Doc. 2010–291 Filed 1–12–10: 8:45 am] Federal, State, and local government iSAFEsafeharbor) (and following the BILLING CODE 6750–01–S programs seek to help elderly or instructions on the web-based form). To disabled individuals maintain their ensure that the Commission considers independence by funding home health an electronic comment, you must file it DEPARTMENT OF THE TREASURY care and other personal services. See, on the web-based form at the weblink for example, Deficit Reduction Act of (https://public.commentworks.com/ftc/ Internal Revenue Service 2005, Public Law 109–171, se. 6071, 120 iSAFEsafeharbor). If this document Stat. 4, 102–110 (2006) (authorizing the appears at (http://www.regulations.gov/ 26 CFR Part 31 Secretary of Health and Human Services search/Regs/home.html#home), you [REG–137036–08] to, among other things, award grants to may also file an electronic comment states to ‘‘[i]ncrease the use of home and through that website. The Commission RIN 1545–BI21 community-based, rather than will consider all comments that institutional, long-term care services.’’) regulations.gov forwards to it. You may Section 3504 Agent Employment Tax The government agencies that also visit the FTC Website at (http:// Liability administer the programs seek to assist www.ftc.gov) to read the document and AGENCY: Internal Revenue Service (IRS), the service recipients with employment the news release describing it. Treasury. tax compliance by helping the service A comment filed in paper form recipients to designate agents to report, should include the ‘‘iSAFE Safe Harbor ACTION: Notice of proposed rulemaking. file, and pay employment taxes on their Proposal, P094504’’ reference both in the SUMMARY: This document contains behalf. The IRS and the Treasury text and on the envelope, and should be proposed regulations relating to Department are proposing changes to mailed or delivered to the following employment tax liability of agents the regulations under section 3504, the address: Federal Trade Commission, authorized by the Secretary under section under which a third party can be Office of the Secretary, Room H-135 section 3504 of the Internal Revenue authorized to act as an agent for an Code (Code) to perform acts required of employer, to permit designated agents to 7 The comment must be accompanied by an explicit request for confidential treatment, employers with respect to taxes under provide comprehensive assistance to including the factual and legal basis for the request, the Federal Unemployment Tax Act on these service recipients who are and must identify the specific portions of the wages paid for home care services, as employers. comment to be withheld from the public record. defined in these regulations. These The request will be granted or denied by the 1. Employment Taxes in General Commission’s General Counsel, consistent with proposed regulations affect employers applicable law and the public interest. See FTC who are home care service recipients, as Employers are generally required to Rule 4.9(c), 16 CFR 4.9(c). defined in these regulations, and their withhold income tax and Federal

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Insurance Contributions Act (FICA) services if the employer paid aggregate www.cms.hhs.gov/smdl/downloads/ taxes from their employees’ wages wages of $1,000 or more (for all Rvltcneeds.pdf. The programs authorize under sections 3402(a) and 3102(a), domestic employees) in any calendar the use of certain intermediaries to serve respectively, and are separately liable quarter in the current or prior year. as agents to disburse payments to for the employer’s share of FICA taxes Section 3306(c)(2). service providers on the service and Federal Unemployment Tax Act recipient’s behalf. The federal, State, or 3. Agency Relationship Under Code (FUTA) taxes under sections 3111 and local government agencies that Section 3504 3301, respectively (collectively referred administer these programs screen to herein as ‘‘employment taxes’’). Section 3504 of the Code authorizes intermediaries before they are entrusted Sections 3102(b), 3111, 3301, and 3403 the Secretary of the Treasury to with funds to pay for the services. provide that the employer is the person promulgate regulations to authorize an Intermediaries can be public or private liable for the withholding and payment agent to perform certain specified acts entities. Many are nonprofit of employment taxes; additionally, the required of employers. Under section organizations. The IRS addressed employer is required to make tax 3504, all provisions of law (including questions with regard to certain deposits, file employment tax returns, penalties) applicable with respect to intermediaries working with state or and file and furnish Forms W–2, Wage employers are applicable to the agent local government agencies in previous and Tax Statement, to employees and remain applicable to the employer. guidance. See Notice 2003–70, 2003 CB (collectively referred to herein as Accordingly, both the agent and 916. See § 601.601(d)(2). ‘‘employment tax obligations’’). An employer are liable for the employment The service recipient is generally the employer is generally defined as the taxes and penalties associated with the employer of the individuals providing person for whom an individual employer’s employment tax obligations the services for employment tax performs services as an employee. See undertaken by the agent. Section purposes. However the Service Sections 3121(d), 3306(a), and 3401(d). 31.3504–1 of the Employment Tax recognizes that there are some FUTA tax is imposed under section Regulations provides that the IRS may government programs under which 3301 on each employer in an amount authorize an agent to undertake the parents, grandparents, or guardians who equal to a percentage of wages paid by employment tax obligations of an are engaged in providing care for a the employer with respect to employer with respect to income tax disabled child or grandchild receive employment. FUTA tax is imposed on withholding and FICA taxes. The agent funding that do not give rise to an the employer in an amount equal to 6.2 is required to file only one return for employment relationship between the percent of wages. Under section 3306(b), each tax return period using the agent’s service recipient and the care provider. wages of an employee subject to the own employer identification number Although the services generally FUTA tax are limited to $7,000 per (EIN) regardless of the number of constitute domestic services under calendar year. Section 3302 provides for employers for whom the agent acts. The section 3401(a)(3) such that income tax a credit against FUTA tax in the amount current regulations do not authorize an withholding is not required, FICA tax of contributions paid by the employer agent to undertake the employment tax and FUTA tax must still be paid subject into an unemployment fund maintained obligations of an employer with respect to the applicable thresholds, and some during the taxable year under the to the FUTA tax. Thus, an authorized service recipients and their service unemployment law of a State. The agent can act on behalf of the employer providers may agree to voluntarily credit is limited to an amount equal to for income tax withholding and FICA withhold income tax under section 90 percent of the FUTA tax. tax purposes, but the employer must 3402(p). In recent years, many home continue to meet its employment tax care service recipients have applied to 2. Domestic Service Employment obligations with respect to FUTA tax. designate the intermediary that arranges The employment tax obligations of an 4. Home Care Service Recipients to pay their service providers as an employer are modified with respect to agent under section 3504 so that the domestic services provided in a private Federal, State, and local governments intermediary can withhold, report, and home of the employer. Employers are fund programs to provide elderly or pay income tax withholding and FICA not required to withhold income taxes disabled individuals with services to tax on the service recipient’s behalf. on wages paid for domestic services, but assist them with health care or other Designating these intermediaries as may enter into a voluntary withholding personal needs in their homes or agents reduces the administrative agreement to withhold income taxes communities. Following an evolution in burden on the service recipient who from one or more domestic employees. policy that seeks to empower the may not otherwise have an obligation to See sections 3401(a)(3) and 3402(p). An individuals receiving services to have report, file, or pay employment taxes. employer is not liable for FICA taxes autonomy, these programs generally The intermediaries have access to with respect to cash wages for domestic give the service recipients discretion in training in compliance with services as long as the cash wages are selecting the service providers and employment tax requirements and have less than an applicable dollar threshold directing their activities. See Deficit the payroll information from the amount, which is adjusted annually. Reduction Act of 2005 section payments they make to the service Sections 3121(a)(7)(B) and 3121(x). 6071(d)(2)(C)(ii), 120 Stat. at 108 providers. An intermediary that is When the cash wages equal or exceed (providing that the Secretary of Health designated as an agent can efficiently the threshold amount, all of the cash and Human Services shall give handle reporting, filing, and paying wages (including amounts below the preference when awarding grants to income tax withholding and FICA on threshold) paid to that employee by the state applications proposing to provide behalf of multiple service recipients on employer are subject to FICA taxes. For eligible individuals with the a single return. A service recipient can example, the FICA wage threshold for opportunity to receive home and complete the application to designate domestic services for 2009 is $1,700. community-based long-term care the intermediary as agent at the time the This threshold applies separately to services as self-directed services); also recipient enrolls with the intermediary. each employer with respect to each see ‘‘Roadmap to Medicaid Reform,’’ Under the current regulations, a employee. An employer is liable for Centers for Medicare and Medicaid service recipient can designate an FUTA taxes with regard to domestic Services, available at http:// intermediary as agent to handle income

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tax withholding and FICA but cannot recipient in his home or local Act (5 U.S.C. chapter 5) does not apply designate an intermediary as agent to community. Services provided outside to this regulation, and because the pay FUTA tax and file FUTA returns. As the home care service recipient’s private regulation does not impose a collection a result, separate FUTA returns must be home may qualify as home care services of information on small entities, the prepared for thousands of individual for purposes of these regulations even if Regulatory Flexibility Act (5 U.S.C. service recipients reporting small the services do not qualify as domestic chapter 6) does not apply. Pursuant to amounts of wages and FUTA tax. service in a private home of the section 7805(f) of the Internal Revenue employer for purposes of sections Explanation of Provisions Code, this regulation has been 3121(a)(7), 3306(c)(2), and 3401(a)(3), so submitted to the Chief Counsel for These proposed regulations would long as the services are provided within Advocacy of the Small Business amend the current regulations to allow the service recipient’s local community. Administration for comment on its a home care service recipient to Because section 3504 provides that all impact on small business. designate an agent under section 3504 to provisions of law applicable to an report, file, and pay all employment employer apply to the agent, the agent Comments and Requests for Public taxes, including FUTA. This change will can report on its aggregate FUTA tax Hearing allow an intermediary to file a single return the state unemployment Before these proposed regulations are FUTA return on behalf of multiple contributions paid into a state adopted as final regulations, home care service recipients as the unemployment fund on the home care consideration will be given to any intermediary does currently with service recipient’s behalf as a credit written or electronic comments that are respect to income tax withholding and under section 3302 against the FUTA submitted timely to the IRS. The FICA. tax. The credit can be reported by the Treasury Department and the IRS Specifically, the proposed regulation agent regardless of whether the state specifically request comments on the would amend the employment tax unemployment contributions are made clarity of the proposed regulations and regulations under section 3504 to under the name and state identifying how they can be made easier to provide that the IRS may authorize a number of the home care service understand. All comments will be party to act as agent on behalf of recipient or the agent. available for public inspection and employers who are home care service These regulations also propose copying. A public hearing will be recipients with respect to FUTA taxes amendments to modify the existing scheduled and held upon written imposed on wages paid for home care regulations under section 3504 to be request by any person who submits services, provided that the party has consistent with the organizational written comments on the proposed been authorized to act as an agent for structure of the IRS and to update the regulation. If a public hearing is those home care service recipients for citation to the Internal Revenue Code of scheduled, notice of the time and place income tax withholding and FICA tax 1986. purposes. The agent is permitted to act for the hearing will be published in the for FUTA tax purposes only on behalf Proposed Effective Date Federal Register. of employers who are home care service These regulations are proposed to Drafting Information recipients, and not for any other type of apply to wages paid on or after January employer on whose behalf the agent is 1 of the calendar year following the date The principal author of these authorized to act for income tax of publication of a Treasury decision proposed regulations is Selvan withholding and FICA tax purposes. adopting these rules as final regulations Boominathan, Office of Division Additionally, the agent is permitted to in the Federal Register. Taxpayers may Counsel/Associate Chief Counsel (Tax act as an agent for FUTA tax purposes rely on these proposed regulations for Exempt and Government Entities), only with respect to wages paid for guidance pending the issuance of final Internal Revenue Service. However, home care services rendered to the regulations. Additionally, pursuant to personnel from other offices of the IRS home care service recipient. section 7805(b)(7), taxpayers may apply and Treasury participated in their These regulations propose to define these proposed regulations to all taxable development. the term home care service recipient as years for which a valid designation as List of Subjects in 26 CFR Part 31 an individual who is an enrolled an agent has been in effect under participant in a program administered § 31.3504–1(a) of the Employment Tax Employment taxes, Income taxes, by a Federal, State, or local government Regulations. Thus, prior to publication Penalties, Pensions, Reporting and agency that provides Federal, State, or of a Treasury decision adopting these recordkeeping requirements, Railroad local government funds to pay, in whole rules as final regulations, any party retirement, Social Security, or in part, for the provision of home care already authorized under section 3504 Unemployment compensation. services, as defined in the proposed to serve as an agent for a home care Proposed Amendments to the regulations. A participant qualifies as a service recipient, as defined in the Regulations home care service recipient while proposed regulations, or with an Accordingly, 26 CFR part 31 is enrolled in such a program and until the application pending, will not need to proposed to be amended as follows: end of the calendar year in which the file any additional application in order participant ceases to be enrolled in the to expand the scope of the agency to PART 31—EMPLOYMENT TAXES AND program. In all such programs, cover FUTA taxes. COLLECTION OF INCOME TAX AT intermediaries who are engaged to assist SOURCE beneficiaries to receive and distribute Special Analyses funds on the beneficiaries’ behalf are It has been determined that this notice Paragraph 1. The authority citation reviewed and approved by a state or of proposed rulemaking is not a for part 31 continues to read in part as local government agency. significant regulatory action as defined follows: These regulations propose to define in Executive Order 12866. Therefore, a Authority: 26 U.S.C. 7805 * * * home care services to include health regulatory assessment is not required. It care and personal attendant care also has been determined that section Par. 2. Section 31.3504–1 is revised to services rendered to a home care service 553(b) of the Administrative Procedure read as follows:

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§ 31.3504–1 Designation of Agent by services includes health care and requests to open while still providing Application. personal attendant care services for the reasonable needs of navigation. (a) In general. In the event wages as rendered in the home care service DATES: Comments and related material defined in chapter 21 or 24 of the recipient’s home or local community. must be received by the Coast Guard on Internal Revenue Code of 1986, or (3) Home care service recipient. For or before February 12, 2010. compensation as defined in chapter 22 purposes of this section, the term home ADDRESSES: You may submit comments of the Code, of an employee or group of care service recipient means any identified by docket number USCG– employees, employed by one or more individual who receives home care 2009–1021 using any one of the employers, is paid by a fiduciary, agent, services, as defined in paragraph (b)(2) following methods: or other person (‘‘agent’’), or if that agent of this section, while enrolled, and for • Federal Rulemaking Portal: http:// has the control, receipt, custody, or the remainder of the calendar year after www.regulations.gov. disposal of those wages, or ceasing to be enrolled, in a program • Fax: 202–493–2251. compensation, the Internal Revenue administered by a Federal, state, or local • Mail: Docket Management Facility Service may, subject to the terms and government agency that provides (M–30), U.S. Department of conditions as it deems proper, authorize Federal, state, or local government Transportation, West Building Ground that agent to perform the acts required funds, to pay, in whole or in part, for Floor, Room W12–140, 1200 New Jersey of the employer or employers under the home care services for that Avenue, SE., Washington, DC 20590– those provisions of the Code and the individual. 0001. regulations which have application, for (c) Effective and applicability dates. • Hand delivery: Same as mail purposes of the taxes imposed by the An authorization under paragraph (a) of address above, between 9 a.m. and 5 chapter or chapters, in respect of the this section in effect prior to the date of p.m., Monday through Friday, except wages or compensation. If the agent is publication of a Treasury decision Federal holidays. The telephone number authorized by the Internal Revenue adopting these rules as final regulations is 202–366–9329. Service to perform such acts, all in the Federal Register continues to be To avoid duplication, please use only provisions of law (including penalties) in effect after that date. Paragraph (b) of one of these methods. See the ‘‘Public and of the regulations applicable to an this section applies to wages paid on or Participation and Request for employer shall be applicable to the after January 1 of the calendar year Comments’’ portion of the agent. However, each employer for following the date of publication of a SUPPLEMENTARY INFORMATION section whom the agent acts shall remain Treasury decision adopting these rules below for instructions on submitting subject to all provisions of law as final regulations in the Federal comments. (including penalties) and of the Register. However, pursuant to section FOR FURTHER INFORMATION CONTACT: If regulations applicable to an employer. 7805(b), taxpayers may rely on Any application to authorize an agent to you have questions on this proposed paragraph (b) of this section for all rule, call or e-mail Judy Leung-Yee, perform such acts, signed by the agent taxable years for which a valid and the employer, shall be made on the Project Officer, U.S. Coast Guard; designation is in effect under paragraph telephone 212–668–7165, e-mail form prescribed by the Internal Revenue (a) of this section. Service and shall be filed with the [email protected]. If you have Internal Revenue Service as prescribed Linda M. Kroening, questions on viewing or submitting in the instructions to the form and other Acting Deputy Commissioner for Services and material to the docket, call Renee V. applicable guidance. Enforcement. Wright, Program Manager, Docket (b) Special rule for home care service [FR Doc. 2010–415 Filed 1–12–10; 8:45 am] Operations, telephone 202–366–9826. recipients. (1) In general. In the event a BILLING CODE 4830–01–P SUPPLEMENTARY INFORMATION: fiduciary, agent, or other person (‘‘agent’’) is authorized pursuant to Public Participation and Request for paragraph (a) of this section to perform Comments DEPARTMENT OF HOMELAND the acts required of an employer under We encourage you to participate in SECURITY chapters 21 or 24 on behalf of one or this rulemaking by submitting more home care service recipients, as Coast Guard comments and related materials. All defined in paragraph (b)(3) of this comments received will be posted, section, the Internal Revenue Service 33 CFR Part 117 without change to http:// may authorize that agent to perform the www.regulations.gov and will include acts as are required of employers for [Docket No. USCG–2009–1021] any personal information you have purposes of the tax imposed by chapter provided. RIN 1625–AA09 23 of the Internal Revenue Code of 1986 Submitting Comments with respect to wages paid for home Drawbridge Operation Regulation; New care services, as defined in paragraph Haven Harbor, Quinnipiac and Mill If you submit a comment, please (b)(2) of this section, rendered to the Rivers, CT include the docket number for this home care service recipient. Each home rulemaking (USCG–2009–1021), care service recipient for whom the AGENCY: Coast Guard, DHS. indicate the specific section of this agent performs the acts of an employer ACTION: Notice of proposed rulemaking. document to which each comment and each agent authorized under this applies, and provide a reason for each section to perform the acts of an SUMMARY: The Coast Guard proposes to suggestion or recommendation. You employer shall remain subject to all change the regulation governing the may submit your comments and provisions of law (including penalties) operation of three bridges across the material online (http:// and of the regulations applicable to an Quinnipiac and Mill Rivers at New www.regulations.gov), or by fax, mail or employer with respect to those wages Haven, Connecticut, to relieve the hand delivery, but please use only one paid. bridge owner from the burden of of these means. If you submit a (2) Home care services. For purposes crewing the bridges during time periods comment online via http:// of this section, the term home care when the bridges seldom receive www.regulations.gov, it will be

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considered received by the Coast Guard Public Meeting The bridge owner would like to when you successfully transmit the extend the above roving crew concept to We do not now plan to hold a public comment. If you fax, hand delivery, or be in effect year round. meeting. But you may submit a request mail your comment, it will be As a result, the Coast Guard for one using one of the four methods considered as having been received by implemented a temporary test deviation specified under ADDRESSES. Please the Coast Guard when it is received at (74 FR 27249) on June 9, 2009, to test explain why one would be beneficial. If the Docket Management Facility. We the proposed changes to the drawbridge we determine that one would aid this recommend that you include your name operation schedule in order to help us rulemaking, we will hold one at a time and a mailing address, an e-mail determine whether a permanent change and place announced by a later notice address, or a phone number in the body to the schedule would satisfactorily in the Federal Register. of your document so that we can contact accomplish the bridge owners goal and you if we have questions regarding your Background and Purpose also continue to meet the reasonable submission. needs of navigation. The Ferry Street Bridge at mile 0.7, To submit your comment online, go to The test period was in effect from across the Quinnipiac River has a May 1, 2009 through October 26, 2009. http://www.regulations.gov, click on the vertical clearance in the closed position ‘‘submit a comment’’ box, which will Satisfactory results were received from of 25 feet at mean high water and 31 feet the test insofar as there were no adverse then become highlighted in blue. In the at mean low water. ‘‘Document Type’’ drop down menu impacts to navigation. In addition, we The Grand Avenue Bridge at mile 1.3, select ‘‘Proposed Rules’’ and insert received no objection to the operation across the Quinnipiac River has a ‘‘USCG–2009–1021’’ in the ‘‘Keyword’’ schedule during or after the test period vertical clearance in the closed position box. Click ‘‘Search’’ then click on the ended. As a result of the successful test, of 9 feet at mean high water and 15 feet balloon shape in the ‘‘Actions’’ column. we are proposing to permanently change at mean low water. If you submit your comments by mail or the drawbridge regulations for the three hand delivery, submit them in an The Chapel Street Bridge at mile 0.4, bridges. across the Mill River has a vertical The operation regulation schedule for unbound format, no larger than 81⁄2 by the Tomlinson Bridge, which is owned 11 inches, suitable for copying and clearance of 7 feet at mean high water by the Connecticut Department of electronic filing. If you submit them by and 13 feet at mean low water. The Transportation, will not be changed by mail and would like to know that they existing drawbridge operation this action and will continue to operate reached the Facility, please enclose a regulations are listed at 33 CFR 117.213. as listed in the existing regulation. stamped, self-addressed postcard or The City of New Haven, the owner of envelope. We will consider all the bridges, requested a change to the Discussion of Proposed Rule comments and material received during drawbridge operation regulations for the Ferry Street Bridge across Quinnipiac Under this proposed rule the Ferry the comment period and may change Street Bridge, the Grand Avenue Bridge, the rule based on your comments. River at mile 0.7, the Grand Avenue Bridge across the Quinnipiac River at and the Chapel Street Bridge would Viewing Comments and Documents mile 1.3, and the Chapel Street Bridge operate as follows: The Ferry Street Bridge across To view comments, as well as at mile 0.4, across the Mill River, all at New Haven, Connecticut. Quinnipiac River at mile 0.7, would documents mentioned in this preamble open on signal for all marine traffic; During the past four years the Ferry as being available in the docket, go to except that, from 7:30 a.m. to 8:30 a.m. Street Bridge has undergone a major http://www.regulations.gov, click on the and 4:45 p.m. to 5:45 p.m., weekdays rehabilitation. During the rehabilitation ‘‘read comments’’ box, which will then except Federal holidays, the draw need project the movable spans were become highlighted in blue. In the not be opened for the passage of vessel removed or left in the open position at ‘‘Keyword’’ box insert ‘‘USCG–2009– traffic. From 9 p.m. to 5 a.m., the draw various times allowing navigation to 1021’’ and click ‘‘Search.’’ Click the would open on signal if at least a one pass at all times. ‘‘Open Docket Folder’’ in the ‘‘Actions’’ hour advance notice is given to the draw column. You may also visit either the Now that the Ferry Street Bridge is tender at the Chapel Street Bridge by Docket Management Facility in Room fully operational again, the bridge calling (203) 946–7618. W12–140 on the ground floor of the owner would like to change the The Grand Avenue Bridge across Department of Transportation West drawbridge operation schedule for all its Quinnipiac River at mile 1.3, would Building, 1200 New Jersey Avenue, SE., bridges, the Ferry Street Bridge, the open on signal for all marine traffic; Washington, DC 20590, between 9 a.m. Grand Avenue Bridge and the Chapel except that, from 7:30 a.m. to 8:30 a.m. and 5 p.m., Monday through Friday, Street Bridge, to help reduce the burden and 4:45 p.m. to 5:45 p.m., weekdays except Federal holidays. We have an of crewing these bridges during time except Federal holidays, the draw need agreement with the Department of periods when there have been few not be opened for the passage of vessel Transportation to use the Docket requests to open the bridges. traffic. From 9 p.m. to 5 a.m. the draw Management Facility. The waterway users are seasonal would open on signal if at least a one recreational craft, commercial fishing, Privacy Act hour advance notice is given to the draw and construction vessels. tender at the Chapel Street Bridge by Anyone can search the electronic The existing drawbridge operation calling (203) 946–7618. form of comments received into any of regulation listed at 33 CFR 117.213, The Chapel Street Bridge across the our dockets by the name of the authorizes a roving crew concept that Mill River at mile 0.4, would open on individual submitting the comment (or requires the draw of the Ferry Street signal for all marine traffic; except that, signing the comment, if submitted on Bridge to open on signal from October from 7:30 a.m. to 8:30 a.m. and 4:45 behalf of an association, business, labor 1 through April 30, between 9 p.m. and p.m. to 5:45 p.m., weekdays except union, etc.). You may review a Privacy 5 a.m. unless the draw tender is at the Federal holidays, the draw need not be Act notice regarding our public dockets Grand Ave or Chapel Street bridges, in opened for the passage of vessel traffic. in the January 17, 2008, issue of the which case, a delay of up to one hour From 9 p.m. to 5 a.m. the draw would Federal Register (73 FR 3316). in opening is permitted. open on signal if at least a one hour

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advance notice is given to the draw during or after the test period ended and Taking of Private Property tender by calling (203) 946–7618. found that the operation schedule met This proposed rule would not affect a Under the existing regulation all the the reasonable needs of navigation. taking of private property or otherwise above bridges are allowed to remain If you think that your business, have taking implications under closed from noon to 12:15 and from organization, or governmental Executive Order 12630, Governmental 12:45 to 1 p.m. in addition to the jurisdiction qualifies as a small entity Actions and Interference with morning and afternoon rush hour time and that this rule would have a Constitutionally Protected Property periods. The noon time closure periods, significant economic impact on it, Rights. noon to 12:15 and 12:25 to 1 p.m., will please submit a comment (see Civil Justice Reform be removed from all the above bridges, ADDRESSES) explaining why you think it except the Tomlinson Bridge. qualifies and how and to what degree This proposed rule meets applicable The Coast Guard is also removing this rule would economically affect it. standards in sections 3(a) and 3(b)(2) of obsolete language from the regulation as Executive Order 12988, Civil Justice part of this action. Paragraphs (4)(b) Assistance for Small Entities Reform, to minimize litigation, through (4)(f) shall be removed because eliminate ambiguity, and reduce Under section 213(a) of the Small they are now listed under Subpart A— burden. General Requirements, § 117.31 and Business Regulatory Enforcement § 117.15, and are redundant as a result. Fairness Act of 1996 (Pub. L. 104–121), Protection of Children we want to assist small entities in We have analyzed this proposed rule Regulatory Analyses understanding this proposed rule so that under Executive Order 13045, We developed this proposed rule after they can better evaluate its effects on Protection of Children from considering numerous statutes and them and participate in the rulemaking. Environmental Health Risks and Safety executive orders related to rulemaking. If the rule would affect your small Risks. This rule is not an economically Below we summarize our analyses business, organization, or governmental significant rule and would not create an based on 13 of these statutes or jurisdiction and you have questions environmental risk to health or risk to executive orders. concerning its provisions or options for safety that might disproportionately compliance, please contact Commander affect children. Regulatory Planning and Review (dpb), First Coast Guard District, Bridge This proposed rule is not a Branch, One South Street, New York, Indian Tribal Governments ‘‘significant regulatory action’’ under NY 10004. The telephone number is This proposed rule does not have section 3(f) of Executive Order 12866, (212) 668–7165. The Coast Guard will Tribal implications under Executive Regulatory Planning and Review, and not retaliate against small entities that Order 13175, Consultation and does not require an assessment of question or complain about this Coordination with Indian Tribal potential costs and benefits under proposed rule or any policy or action of Governments, because it would not have section 6(a)(3) of that Order. The Office the Coast Guard. a substantial direct effect on one or of Management and Budget has not Collection of Information more Indian Tribes, on the relationship reviewed it under that Order. This between the Federal Government and conclusion is based upon the fact that This proposed rule would call for no Indian Tribes, or on the distribution of we tested the above drawbridge new collection of information under the power and responsibilities between the operation schedule and found that it Paperwork Reduction Act of 1995 (44 Federal Government and Indian Tribes. met the reasonable needs of navigation. U.S.C. 3501–3520.). Energy Effects Small Entities Federalism We have analyzed this proposed rule Under the Regulatory Flexibility Act under Executive Order 13211, Actions (5 U.S.C. 601–612), we have considered A rule has implications for federalism Concerning Regulations That whether this proposed rule would have under Executive Order 13132, Significantly Affect Energy Supply, a significant economic impact on a Federalism, if it has a substantial direct Distribution, or Use. We have substantial number of small entities. effect on State or local governments and determined that it is not a ‘‘significant The term ‘‘small entities’’ comprises would either preempt State law or energy action’’ under that order because small businesses, not-for-profit impose a substantial direct cost of it is not a ‘‘significant regulatory action’’ organizations that are independently compliance on them. We have analyzed under Executive Order 12866 and is not owned and operated and are not this proposed rule under that Order and likely to have a significant adverse effect dominant in their fields, and have determined that it does not have on the supply, distribution, or use of governmental jurisdictions with implications for federalism. energy. The Administrator of the Office populations of less than 50,000. Unfunded Mandates Reform Act of Information and Regulatory Affairs The Coast Guard certifies under 5 has not designated it as a significant U.S.C. 605(b) that this proposed rule The Unfunded Mandates Reform Act energy action. Therefore, it does not would not have a significant economic of 1995 (2 U.S.C. 1531–1538) requires require a Statement of Energy Effects impact on a substantial number of small Federal agencies to assess the effects of under Executive Order 13211. entities. This action will not have a their discretionary regulatory actions. In significant economic impact on a particular, the Act addresses actions Technical Standards substantial number of small entities for that may result in the expenditure by a The National Technology Transfer the following reasons. A test period was State, local, or Tribal government, in the and Advancement Act (NTTAA) (15 in effect from May 1, 2009 through aggregate, or by the private sector of U.S.C. 272 note) directs agencies to use October 26, 2009. Satisfactory results $100,000,000 or more in any one year. voluntary consensus standards in their were received from the test insofar as Though this proposed rule will not regulatory activities unless the agency there were no adverse impacts to result in such an expenditure, we do provides Congress, through the Office of navigation. In addition, we received no discuss the effects of this rule elsewhere Management and Budget, with an objection to the operation schedule in this preamble. explanation of why using these

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standards would be inconsistent with (b) The draw of the Ferry Street jaguar in accordance with the Act this applicable law or otherwise impractical. Bridge at mile 0.7, across Quinnipiac fiscal year and anticipate we will Voluntary consensus standards are River, shall open on signal; except that, publish a proposed designation in technical standards (e.g., specifications from 7:30 a.m. to 8:30 a.m. and 4:45 January 2011. of materials, performance, design, or p.m. to 5:45 p.m., Monday through DATES: To be considered in the operation; test methods; sampling Friday, except Federal holidays, the proposed critical habitat designation, procedures; and related management draws need not open for the passage of comments and information should be systems practices) that are developed or vessel traffic. From 9 p.m. to 5 a.m. the submitted to us by March 15, 2010. adopted by voluntary consensus draw shall open on signal if at least a ADDRESSES: You may submit comments standards bodies. one-hour advance notice is given by by one of the following methods: This proposed rule does not use calling the number posted at the bridge. • Electronically: Go to the Federal technical standards. Therefore, we did (c) The draw of the Grand Avenue eRulemaking Portal: http:// not consider the use of voluntary Bridge at mile 1.3, across the www.regulations.gov. In the Keyword consensus standards. Quinnipiac River shall open on signal; box, enter Docket No. [FWS-R2-ES- except that, from 7:30 a.m. to 8:30 a.m. Environment 2009-0091], which is the docket number and 4:45 p.m. to 5:45 p.m., Monday for this rulemaking. Then, in the Search We have analyzed this proposed rule through Friday, except Federal holidays, panel on the left side of the screen, under Department of Homeland the draw need not open for the passage under the Document Type heading, Security Management Directive 023–01, of vessel traffic. From 9 p.m. to 5 a.m. click on the Proposed Rules link to and Commandant Instruction the draw shall open on signal if at least locate this document. You may submit M16475.lD which guides the Coast a one-hour advance notice is given by a comment by clicking on ‘‘Send a Guard in complying with the National calling the number posted at the bridge. Comment or Submission.’’ Environmental Policy Act of 1969 (d) The draw of the Chapel Street • By hard copy: Submit by U.S. mail (NEPA) (42 U.S.C. 4321–4370f), and Bridge at mile 0.4, across the Mill River or hand-delivery to: Public Comments have made a preliminary determination shall open on signal; except that, from Processing, Attn: FWS-R2-ES-2009- that this action is one of a category of 7:30 a.m. to 8:30 a.m. and 4:45 p.m. to 0091; Division of Policy and Directives actions which do not individually or 5:45 p.m., Monday through Friday, Management; U.S. Fish and Wildlife cumulatively have a significant effect on except Federal holidays, the draw need Service; 4401 N. Fairfax Drive, Suite the human environment because it not open for the passage of vessel traffic. 222; Arlington, VA 22203. simply promulgates the operating From 9 p.m. to 5 a.m. the draw shall We will post all comments on http:// regulations or procedures for open on signal after at least a one-hour www.regulations.gov. This generally drawbridges. We seek any comments or advance notice is given by calling the means that we will post any personal information that may lead to the number posted at the bridge. information you provide us (see Public discovery of a significant environmental Dated: December 28, 2009. Comment Procedures and Public impact from this proposed rule. Availability of Comments under Joseph L. Nimmich, List of Subjects in 33 CFR Part 117 SUPPLEMENTARY INFORMATION for more Rear Admiral, U.S. Coast Guard, Commander, information). Bridges. First Coast Guard District. FOR FURTHER INFORMATION CONTACT: For the reasons discussed in the [FR Doc. 2010–435 Filed 1–12–10; 8:45 am] Steve Spangle, Field Supervisor, preamble, the Coast Guard proposes to BILLING CODE 9110–04–P Arizona Ecological Services Office, 2321 amend 33 CFR part 117 as follows: West Royal Palm Road, Suite 103, PART 117—DRAWBRIDGE DEPARTMENT OF THE INTERIOR Phoenix, AZ 85021-4951; telephone OPERATION REGULATIONS (602) 242-0210; facsimile (602) 242- Fish and Wildlife Service 2513. If you use a telecommunications 1. The authority citation for part 117 device for the deaf (TDD), call the continues to read as follows: 50 CFR Part 17 Federal Information Relay Service Authority: 33 U.S.C. 499; 33 CFR 1.05–1; (FIRS) at 800–877–8339. [Docket No. FWS-R2-ES-2009-0091; Department of Homeland Security Delegation SUPPLEMENTARY INFORMATION: BFY2009-92210-1117-0000-B2] No. 0170.1. Background 2. Revise § 117.213 to read as follows: Endangered and Threatened Wildlife and Plants; Determination That The jaguar, a large member of the cat § 117.213 New Haven Harbor, Quinnipiac Designation of Critical Habitat is family (Felidae), is an endangered and Mill Rivers. Prudent for the Jaguar species that currently occurs from The draws of the Tomlinson Bridge, southern Arizona and New Mexico to mile 0.0, the Ferry Street Bridge, mile AGENCY: Fish and Wildlife Service, southern South America. Jaguars in the 0.7, and the Grand Avenue Bridge, mile Interior. United States are part of a population, 1.3, across the Quinnipiac River, and ACTION: Notice of determination. or populations, that occur in Mexico. the Chapel Street Bridge, mile 0.4, Below we present a summary of relevant across the Mill River, shall operate as SUMMARY: We, the U.S. Fish and information we used in making our follows: Wildlife Service (Service), under the determination that designating critical (a) The draw of the Tomlinson Bridge Endangered Species Act of 1973, as habitat in the United States for the at mile 0.0, across the Quinnipiac River amended (Act), have reconsidered our jaguar is prudent. For more information shall open on signal; except that, from prudency determination concerning the regarding all aspects of the jaguar, refer 7:30 a.m. to 8:30 a.m., noon to 12:15 designation of critical habitat for the to documents posted on our jaguar p.m., 12:45 p.m. to 1 p.m., and 4:45 p.m. jaguar (Panthera onca) and now find webpage (http://www.fws.gov/ to 5:45 p.m., Monday through Friday, that designation of critical habitat is southwest/es/arizona/Jaguar.htm), and except Federal holidays, the draw need prudent. We are preparing a proposed Jaguar Conservation Team documents not open for the passage of vessel traffic. designation of critical habitat for the and notes (www.azgfd.gov/w_c/es/

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jaguar_management.shtml), and the Rabinowitz (as cited by Nowell and the Service maintained separate listings literature cited there. Jackson 1996, p. 121) estimated Belize’s for foreign species and species native to Jaguars in the United States jaguar population at between 600 and the United States. At that time, the historically occurred in California, 1,000 individuals. Experts reported jaguar was believed to be extinct in the Arizona, New Mexico, Texas, and 5,680 observations of jaguars (some of United States; thus, the jaguar was only possibly Louisiana (62 FR 39147; July these are likely observations of the same included on the foreign species list. The 22, 1997). The last confirmed jaguar animal) at 535 separate locations jaguar’s range was described as sightings in California, Texas, and throughout the entire range during the extending from the international Louisiana were in the late 1800s or early last 10 years (Sanderson et al. 2002, p. boundary of the United States and 1900s. While jaguars have been 62). There are estimates of jaguar Mexico southward to include Central documented as far north as the Grand densities ranging from 1.7 to 4 adults and South America (37 FR 6476). On Canyon, sightings in the United States per 38.6 square mi (100 square km) in July 22, 1997, we published a final from 1996 to the present have occurred Brazil, Peru, Colombia, and Mexico, listing rule that extended endangered mainly within approximately 40 miles with the highest density found in Belize status for the jaguar into the United (mi) (64.4 kilometers (km)) of the (6-8 per 100 square km) (International States (62 FR 39147). For more international boundary of the United Union for the Conservation of Nature information on previous Federal actions States and Mexico. Based on (IUCN) 2008, p. 5). concerning the jaguar, please refer to the documented sightings in the late 20th July 22, 1997, final listing rule (62 FR Critical Habitat century, occurrences in the United 39147). States at the time of the July 22, 1997, Critical habitat is defined in section 3 The July 22, 1997, listing rule listing (62 FR 39147) were limited to of the Act as—(i) The specific areas included a determination that southeastern Arizona and southwestern within the geographical area occupied designation of critical habitat for the New Mexico. by a species, at the time it is listed in jaguar was not prudent (62 FR 39147). Recently (1996 through 2009), four or accordance with the Act, on which are At that time we determined that the possibly five jaguars have been found those physical or biological greatest threat to the jaguar in the documented in the United States features (I) essential to the conservation United States was from direct taking of (McCain and Childs 2008, p. 5; Service of the species and (II) which may individuals through shooting or other files). Of those, two jaguars were require special management means. As a consequence, we photographed in the United States in considerations or protection; and, (ii) determined that designating critical 1996: one on March 7 in the Peloncillo specific areas outside the geographical habitat for the jaguar was ‘‘not prudent,’’ Mountains, located along the Arizona— area occupied by a species at the time because ‘‘publication of detailed critical New Mexico border (Glenn 1996; Brown it was listed, upon a determination that habitat maps and descriptions in the and Lopez Gonzalez 2001, p. 6), and such areas are essential for the Federal Register would likely make the another on August 31 in the Baboquivari conservation of the species. species more vulnerable to activities Mountains in southern Arizona (Childs ‘‘Conservation’’ means the use of all prohibited under section 9 of the Act,’’ 1998, p. 7; Brown and Lopez Gonzalez methods and procedures needed to and therefore increase the degree of 2001, p. 6). In February 2006, a third bring the species to the point at which threat to the species. jaguar was observed and photographed listing under the Act is no longer In response to a complaint by the in Hidalgo County, New Mexico. Using necessary. Center for Biological Diversity, we camera traps, jaguars were Section 4(a)(3) of the Act, as agreed to re-evaluate our 1997 prudency photographed in the United States near amended, and its implementing determination and make a new the Arizona—Mexico border beginning regulations at 50 CFR 424.12, require determination as to whether designation in 2001, and as recently as February that, to the maximum extent prudent of critical habitat for the jaguar was 2009. This survey effort resulted in the and determinable, the Secretary prudent by July 3, 2006. In that detection of the male jaguar originally designate critical habitat at the time a subsequent finding (July 12, 2006; 71 FR observed in the Baboquivari Mountains species is determined to be endangered 39335), we noted that since the time of in 1996 referred to above; and possibly or threatened. According to our our July 22, 1997, determination, the a fifth jaguar that was unidentified and regulations in the Code of Federal Jaguar Conservation Team, Arizona not determined as to sex. No females or Regulations (CFR) at (50 CFR Game and Fish Department, kittens were detected as a result of this 424.12(a)(1)) designation of critical publications, and other sources monitoring effort. Monitoring of jaguars habitat is not prudent when one or both routinely have given specific and with the use of camera traps in the of the following situations exist—(1) general locations of jaguars that have United States has been geographically The species is threatened by taking or been sighted and currently are being limited in scope (from the crest of the other human activity, and identification documented in the United States Baboquivari Mountains east to the San of critical habitat can be expected to through websites, public notifications, Rafael Valley and approximately 50 mi increase the degree of threat to the reports, books, and meeting notes. (80 km) north of the international species, or (2) such designation of Publishing critical habitat maps and boundary) (McCain and Childs 2008, p. critical habitat would not be beneficial descriptions, as part of designating 5). Therefore, we cannot make to the species. critical habitat, would not result in the conclusions regarding the presence of species being more vulnerable in the other jaguars, including females and Previous Federal Actions United States than it is currently. We kittens, outside the scope of this In 1972, the jaguar was listed as then assessed whether designation of monitoring effort. endangered (37 FR 6476; March 30, critical habitat would be beneficial to We are not aware of any 1972) in accordance with the the species. We found that no areas in comprehensive rangewide population Endangered Species Conservation Act of the United States meet the definition of estimates for jaguars; however, Cha´vez 1969, a precursor to the Endangered critical habitat and, as a result, and Ceballos (2006, p. 10) report the Species Act of 1973, as amended (Act; designation of critical habitat for the jaguar population in Mexico is 16 U.S.C. 1531 et seq.). Under the jaguar would not be beneficial to the estimated at less than 5,000, and Endangered Species Conservation Act, species. As a result, we again

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determined that designation of critical beneficial. We also determine that preparation, the areas occupied by habitat for the jaguar was not prudent designation of critical habitat will not be jaguars in the United States will (71 FR 39335). We did not consider expected to increase the degree of threat continue to be subject to conservation designation of lands outside of the to the species. As such, we no longer actions implemented under section United States in this analysis, because, find that designation of critical habitat 7(a)(1) of the Act, as well as under the Act’s implementing for the jaguar is not prudent under our consultation pursuant to section 7(a)(2) regulations, critical habitat cannot be regulations, and conversely, therefore of the Act for Federal activities that may designated in foreign countries (50 CFR determine that designation is prudent. affect jaguars, as determined on the 424.12(h)). We discuss below how we intend to basis of the best available scientific The Center for Biological Diversity proceed with developing a proposed information at the time of the action. In again challenged the Service’s decision designation of critical habitat for the addition, the prohibition of taking that critical habitat was not prudent for jaguar. jaguars under section 9 of the Act (e.g., the jaguar. On March 30, 2009, the prohibitions against killing, harming, How the Service Intends to Proceed United States District Court for the harassing, and capturing jaguars) District of Arizona (Court) issued an We intend to begin preparation of continues to apply, which addresses the opinion in Center for Biological proposed rulemaking for the jaguar in single greatest threat to the species in Diversity v. Kempthorne, CV 07-372- Fiscal Year 2010 and publish a the United States, as discussed in the TUC JMR (Lead) and Defenders of proposed critical habitat designation in final listing rule. Wildlife v. Hall, CV08-335 TUC JMR January 2011. Based on the best We will also continue to use our (Consolidated) (D. Ariz., Mar. 30, 2009) available science, we will take the authorities to work with agencies and that set aside our previous prudency following steps to develop a proposal of other partners in the United States, determination and required that we critical habitat for the jaguar: (1) Mexico, and Central and South America issue a new determination as to Determine the geographical area to conserve and recover jaguars. We are ‘‘whether to designate critical habitat,’’ occupied by the species at the time of working with the Jaguar Conservation i.e., whether such designation is listing; (2) identify the physical or Team and other partners to develop and prudent, by January 8, 2010. In this biological features essential to the implement a framework for the opinion, the Court noted, among other conservation of the species; (3) delineate conservation of the northern jaguar things, that the Service’s regulations at areas within the geographical area populations, including providing 50 CFR 424.12(b) require that the occupied by the species that contain recommendations on research needs Service ‘‘shall focus on the principal these features, and identify the special and procedures in the United States, biological constituent elements within management considerations or continuing education efforts, and the defined area that are essential to the protections the features may require; (4) providing recommendations regarding conservation of the species.’’ Such delineate any areas outside of the predator control in areas where jaguars elements include consideration of space geographical area occupied by the may occur. We are also working with for individual and population growth, species at the time of listing that are Mexican partners, such as Naturalia and and for normal behavior; food, water, essential for the conservation of the La Comisio´n Nacional de a´reas air, light, minerals, or other nutritional species; (5) conduct appropriate Protegidas (CONANP) and other or physiological requirements; cover or analyses under section 4(b)(2) of the partners on jaguar conservation in shelter; sites for breeding, reproduction, Act; and (6) invite the public to review Mexico through the Trilateral rearing of offspring, germination, or and provide comments on the proposed Commission and other processes. The seed dispersal; and habitats that are critical habitat rule through a public Service’s Wildlife Without Borders protected from disturbance or are comment period. program has funded and will likely representative of the historic To aid us in completing these steps, continue to fund jaguar conservation geographical and ecological we will use the best science available, projects throughout the range of the distributions of a species. including but not limited to Boydston jaguar in Latin America. Mexico and and Lo´pez Gonza´lez 2005, Brown and countries in Central and South America, Prudency Determination Lo´pez Gonza´lez 2000, Brown and Lo´pez along with their nongovernmental As instructed by the Court, we have Gonza´lez 2001, Carrillo et al. 2007, partners, are continuing conservation reevaluated our previous ‘‘not prudent’’ Cavalcanti 2008, Ceballos et al. 2006, efforts, including implementing finding regarding critical habitat Cha´vez and Ceballos 2006, Cha´vez et al. research programs and developing designation for the jaguar and the 2007a, Cha´vez et al. 2007b, Grigione et conservation plans. Specifically, Federal information supporting our previous al. 2007, Grigione et al. 2009, Hatten et and State agencies in Mexico are findings. We have also evaluated al. 2002, Hatten et al. 2005, Marieb developing jaguar conservation plans; information and analysis that has 2005, McCain and Childs 2008, we intend to coordinate with Mexico in become available to us subsequent to Medellin et al. 2002, Menke and Hayes their development to maintain travel the July 12, 2006, finding. As discussed 2003, Monroy-Vichis et al. 2007, corridors for jaguars into the United in the Background section above, Navarro Serment et al. 2005, States. jaguars have been found in the United Nu´ xntilde;ez et al. 2002, Oropeza States in the past and may occur in the Herna´ndez et al. 2009, Robinson 2006, Request for Public Information United States now or in the future. As Rosas Rosas 2006, Sanderson et al. We intend that any designation of such, there are physical and biological 2002, and Sierra Institute 2000. We also critical habitat for the jaguar be as features that can be used by jaguars in solicit the public for additional accurate as possible. Therefore, we will the United States. Thus, in responding information (see Request for Public continue to accept additional to the Court’s order, and following a Information section below) and will information and comments from all review of the best available information, consult experts on the jaguar, including concerned governmental agencies, the including the ongoing conservation experts on the jaguar in the northern scientific community, industry, or any programs for the jaguar, we now portion of its range. other interested party concerning this determine that the designation of While the proposed designation of finding. We are particularly interested critical habitat for the jaguar would be critical habitat for the jaguar is under in information concerning:

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(1) The amount and distribution of Please note that comments submitted to Authority jaguar habitat, both throughout its range this Web site are not immediately The authority for this action is the and within the United States; viewable. When you submit a comment, Endangered Species Act of 1973, as (2) The physical and biological the system receives it immediately. amended (16 U.S.C. 1531 et seq.). features of jaguar habitat that are However, the comment will not be essential to the conservation of the publicly viewable until we post it, Dated: December 30, 2009. species; which might not occur until several Eileen Sobeck, (3) Special management days after submission. Acting Assistant Secretary for Fish, Wildlife and Parks. considerations or protections that the If you mail or hand-carry a hardcopy features essential to the conservation of comment directly to us that includes [FR Doc. 2010–479 Filed 1–12–10; 8:45 am] the jaguar may require, including personal information, you may request BILLING CODE S managing for the potential effects of at the top of your document that we climate change; withhold this information from public DEPARTMENT OF THE INTERIOR (4) Any areas that are essential to the review. However, we cannot guarantee conservation of the jaguar throughout its that we will be able to do so. To ensure Fish and Wildlife Service range and why; that the electronic docket for this (5) The areas in the United States that finding is complete and all comments were occupied at the time of listing that 50 CFR Part 17 we receive are publicly available, we contain features essential to the will post all hardcopy comments on [Docket No. FWS–R2–ES–2008–0130; MO conservation of the species; 92210–0–0008–B2] (6) The areas in the United States that http://www.regulations.gov. were not occupied at the time of listing, In addition, comments and materials Endangered and Threatened Wildlife but are essential to the conservation of we receive, as well as supporting and Plants; Partial 90-Day Finding on the species and why; documentation used in preparing this a Petition to List 475 Species in the (7) Land use designations and current finding, will be available for public Southwestern United States as or planned activities in jaguar habitats inspection in two ways: Threatened or Endangered With and their possible impacts on proposed (1) You can view them on http:// Critical Habitat; Correction critical habitat; www.regulations.gov. In the Search AGENCY: (8) Conservation programs and plans Documents box, enter FWS-R2-ES-2009- Fish and Wildlife Service, that protect the jaguar and its habitat; 0091, which is the docket number for Interior. and this action. Then, in the Search panel on ACTION: Notice of 90-day petition (9) Whether we could improve or the left side of the screen, select the type finding; correction. modify our approach to designating of documents you want to view under critical habitat in any way to provide for SUMMARY: On Wednesday, December 16, the Document Type heading. 2009, we, the U.S. Fish and Wildlife greater public participation and (2) You can make an appointment, understanding, or to better Service, announced a 90-day finding on during normal business hours, to view 192 species from a petition to list 475 accommodate public concerns and the comments and materials in person at comments. species in the Southwest region of the the Arizona Ecological Services Office United States as threatened or Public Comment Procedures (see FOR FURTHER INFORMATION CONTACT). endangered under the Endangered To ensure that any final action Public Availability of Comments Species Act of 1973, as amended (Act). resulting from this finding will be as In that notice, we used an incorrect accurate and as effective as possible, we As stated above in more detail, before docket number in one place and asked request that you send relevant including your address, phone number, commenters submitting hardcopy information for our consideration. The e-mail address, or other personal comments to refer to this docket number comments that will be most useful and identifying information in your in their comments. The correct docket likely to influence our decisions are comment, you should be aware that number is [FWS–R2–ES–2008–0130]. those that you support by quantitative your entire comment—including your However, comments we received under information or studies and those that personal identifying information—may the incorrect docket number will be include citations to, and analyses of, the be made publicly available at any time. routed to the correct docket. If you applicable laws and regulations. Please While you can ask us in your comment already submitted a comment, even make your comments as specific as to withhold your personal identifying with the incorrect docket number, you possible and explain the bases for them. information from public review, we need not resubmit it. In addition, please include sufficient cannot guarantee that we will be able to DATES: To allow us adequate time to information with your comments to do so. conduct a status review, we request that allow us to authenticate any scientific or References Cited we receive information on or before commercial data you include. February 16, 2010. You must submit your comments and A complete list of references cited is ADDRESSES: You may submit materials concerning this finding by one available on the Internet at Docket No. information by one of the following of the methods listed above in the FWS-R2-ES-2009-0091 at http:// methods: ADDRESSES section. We will not accept www.regulations.gov and upon request • Federal rulemaking Portal: http:// comments sent by e-mail or fax or to an from the Arizona Ecological Services www.regulations.gov. Follow the address not listed in ADDRESSES. If you Office (see FOR FURTHER INFORMATION instructions for submitting comments to submit a comment via http:// CONTACT). Docket no. FWS–R2–ES–2008–0130. • www.regulations.gov, your entire Author(s) U.S. Mail or hand delivery: Public comment—including any personal Comments Processing, Attn: FWS–R2– identifying information, such as your The primary author of this notice is ES–2008–0130, Division of Policy and address, telephone number, or e-mail the staff of the U.S. Fish and Wildlife Directives Management, U.S. Fish and address—will be posted on the Web site. Service. Wildlife Service, 4401 N. Fairfax Drive,

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Suite 222, Arlington, VA 22203. We will DEPARTMENT OF COMMERCE comment period has closed. All post all information received on http:// comments received are a part of the www.regulations.gov. This generally National Oceanic and Atmospheric public record and will generally be means that we will post any personal Administration posted to http://www.regulations.gov information you provide us (see the without change. All Personal Identifying Request for Information section in our 50 CFR Part 660 Information (for example, name, original notice—74 FR 66865—for more [Docket No. 0912281446–91447–01] address, etc.) voluntarily submitted by information). the commenter may be publicly RIN 0648–XT32 accessible. Do not submit Confidential FOR FURTHER INFORMATION CONTACT: Business Information or otherwise Fisheries Off West Coast States; Sarah Quamme, Listing Coordinator, sensitive or protected information. Coastal Pelagic Species Fisheries; Southwest Regional Ecological Services NMFS will accept anonymous Annual Specifications Office, 500 Gold Avenue, SW., comments (enter N/A in the required Albuquerque, NM 87102; telephone AGENCY: National Marine Fisheries fields if you prefer to remain 505–248–6920. If you use a Service (NMFS), National Oceanic and anonymous). You may submit telecommunications device for the deaf Atmospheric Administration (NOAA), attachments to electronic comments will (TDD), please call the Federal Commerce. be accepted in Microsoft Word, Excel, Information Relay Service (FIRS) at ACTION: Proposed rule. WordPerfect, or Adobe PDF file formats 800–877–8339. only. SUMMARY: NMFS proposes a regulation Copies of the report ‘‘Assessment of SUPPLEMENTARY INFORMATION: On to implement the annual harvest Pacific Sardine Stock for U.S. Wednesday, December 16, 2009, we guideline (HG) and seasonal allocations Management in 2010’’ may be obtained announced a 90-day finding on 192 for Pacific sardine in the U.S. exclusive from the Southwest Regional Office (see species from a petition we received to economic zone (EEZ) off the Pacific the Mailing address above). list 475 species in the Southwest region coast for the fishing season of January 1, FOR FURTHER INFORMATION CONTACT: of the United States as threatened or 2010, through December 31, 2010. This Joshua Lindsay, Southwest Region, endangered under the Act (16 U.S.C. rule is proposed according to the NMFS, (562) 980–4034. 1531 et seq.) (74 FR 66865). We found Coastal Pelagic Species (CPS) Fishery Management Plan (FMP). The proposed SUPPLEMENTARY INFORMATION: The CPS that the petition presented substantial FMP, which was implemented by information indicating that 67 of the 192 2010 acceptable biological catch (ABC) or maximum HG is 72,039 mt. 5,000 mt publication of the final rule in the species may warrant listing as Federal Register on December 15, 1999 threatened or endangered. When we of this 72,039 mt would initially be set aside for use under an Exempted (64 FR 69888), divides management unit make a finding that a petition presents species into two categories: actively substantial information indicating that Fishing Permit (EFP), if issued, leaving the remaining 65,732 mt as the initial managed and monitored. Harvest listing a species may be warranted, we commercial fishing HG. That HG would guidelines for actively managed species are required to promptly review the be divided across the seasonal (Pacific sardine and Pacific mackerel) status of the species (status review). For allocation periods in the following way: are based on formulas applied to current the status review to be complete and January 1–June 30, 22,463 mt would be biomass estimates. Biomass estimates based on the best available scientific allocated for directed harvest with an are not calculated for species that are and commercial information, we incidental set-aside of 1,000 mt; July 1– only monitored (jack mackerel, northern requested information on each of the 67 September 14, 25,861 mt would be anchovy, and market squid). species from governmental agencies, allocated for directed harvest with an During public meetings each year, the Native American Tribes, the scientific incidental set-aside of 1,000 mt; biomass for each actively managed community, industry, and any other September 15–December 31, 11,760 mt species within the CPS FMP is interested parties. would be allocated for directed harvest presented to the Pacific Fishery In that notice, we asked commenters with an incidental set-aside of 1,000 mt Management Council’s (Council) CPS Management Team (Team), the to refer to an incorrect docket number with an additional 4,000 mt set aside to Council’s CPS Advisory Subpanel when submitting comments via U.S. buffer against reaching the ABC. This (Subpanel) and the Council’s Scientific mail or hand delivery. The correct rule is intended to conserve and manage Pacific sardine off the West Coast. and Statistical Committee (SSC). At that docket number is [FWS–R2–ES–2008– time, the biomass, the ABC and the 0130], and our instructions to persons DATES: Comments must be received by February 2, 2010. status of the fisheries are reviewed and submitting comments electronically discussed. This information is then ADDRESSES: You may submit comments included the correct docket number. All presented to the Council along with HG hardcopy comments received under the on this proposed rule identified by 0648–XT32 by any of the following recommendations and comments from incorrect docket number will be routed the Team, Subpanel and SSC. Following to the correct docket. If you already methods: • Electronic Submissions: Submit all review by the Council and after hearing submitted a comment, even with the electronic public comments via the public comment, the Council makes its incorrect docket number, you need not Federal eRulemaking Portal http:// HG recommendation to NMFS. resubmit it. For more information about www.regulations.gov In November 2009, the Council the species, background, and our • Mail: Rodney R. McInnis, Regional adopted and recommended to NMFS an finding, see our original notice at 74 FR Administrator, Southwest Region, ABC or maximum HG of 72,039 mt for 66865. NMFS, 501 West Ocean Blvd., Suite the 2010 Pacific sardine fishing year. This ABC is based on a biomass Sara Prigan, 4200, Long Beach, CA 90802. estimate of 702,204 mt and the harvest Federal Register Liaison. • Fax: (562)980–4047 control rule established in the CPS FMP. [FR Doc. 2010–454 Filed 1–12–10; 8:45 am] Instructions: No comments will be This ABC/HG is slightly higher than the BILLING CODE 4310–55–P posted for public viewing until after the ABC/HG for the 2009 fishing season,

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which was 66,932 mt. The Council also directed harvest and only incidental on three seasons of sea surface recommended that 5,000 mt of the harvest would be allowed. For the temperature at Scripps Pier, California. available 2010 ABC/HG be initially remainder of the period, any incidental Classification reserved for research activities that Pacific sardine landings would be would be undertaken under a potential counted against that period’s incidental Pursuant to section 304(b)(1)(A) of the exempted fishing permit (EFP). In 2009, set-aside. The proposed incidental Magnuson-Stevens Fishery 2,400 mt was subtracted from the total fishery would also be constrained to a Conservation and Management Act, the HG for an EFP. The Council will hear 30 percent by weight incidental catch NMFS Assistant Administrator has proposals and comments on any rate when Pacific sardine are landed determined that this proposed rule is potential EFPs at the March Council with other CPS so as to minimize the consistent with the CPS FMP, other meeting and make a final targeting of Pacific sardine. In the event provisions of the Magnuson-Stevens recommendation to NMFS on whether that an incidental set aside is projected Fishery Conservation and Management or not to issue an EFP(s) for the 5,000 to be attained, all fisheries will be Act, and other applicable law, subject to mt research set aside at their April 2010 closed to the retention of Pacific sardine further consideration after public Council meeting. NMFS will likely for the remainder of the period. If the comment. make a decision on whether or not to set-aside is not fully attained or is These proposed specifications are issue an EFP some time prior to the start exceeded in a given seasonal period, the exempt from review under Executive of the second seasonal period (July 1, directed harvest allocation in the Order 12866. 2010). Any of the 5,000 mt that is not following seasonal period would The Chief Counsel for Regulation of issued to an EFP will be rolled into the automatically be adjusted to account for the Department of Commerce certified third allocation period’s directed the discrepancy. Additionally, if during to the Chief Counsel for Advocacy of the fishery. Any research set aside any seasonal period the directed harvest Small Business Administration that this attributed to an EFP designed to be allocation is not fully attained or is proposed rule, if adopted, would not conducted during the closed fishing exceeded, then the following period’s have a significant economic impact on time in the second allocation period directed harvest total would be adjusted a substantial number of small entities as (prior to September 15), but not utilized, to account for this discrepancy as well. follows: will roll into the third allocation If the total HG or these apportionment The purpose of this proposed rule is to period’s directed fishery. Any research levels for Pacific sardine are reached or implement the 2010 HG for Pacific sardine in set aside attributed to an EFP designed are expected to be reached, the Pacific the U.S. EEZ off the Pacific coast. The CPS to be conducted during closed fishing sardine fishery would be closed via FMP and its implementing regulations times in the third allocation, but not appropriate rulemaking until it re-opens require NMFS to set an annual HG for the utilized, will not be re-allocated. either per the allocation scheme or the Pacific sardine fishery based on the harvest The Council recommended that the formula in the FMP. The harvest formula is beginning of the next fishing season. applied to the current stock biomass estimate remaining 67,039 mt (HG of 72,039 mt The Regional Administrator would to determine the ABC, from which the HG is minus proposed 5,000 mt EFP set aside) publish a notice in the Federal Register then derived. The HG is determined using an be used as the initial overall fishing HG announcing the date of such closures. environmentally-based formula accounting and be allocated across the seasonal Detailed information on the fishery for the effect of ocean conditions on stock periods established by Amendment 11 and the stock assessment are found in productivity. (71 FR 36999). The Council also the report ‘‘Assessment of Pacific The HG is apportioned based on the recommended an incidental catch set Sardine Stock for U.S. Management in following allocation scheme: 35 percent of aside of 3,000 mt and a management 2010’’ (see ADDRESSES). the HG is allocated coastwide on January 1; uncertainty buffer of 4,000 mt. The formula in the CPS FMP uses the 40 percent of the HG, plus any portion not Subtracting this set aside from the following factors to determine the HG: harvested from the initial allocation is then 1. Biomass. The estimated stock reallocated coastwide on July 1; and on initial overall HG establishes an initial September 15 the remaining 25 percent, plus directed harvest fishery of 60,039 mt biomass of Pacific sardine age one and any portion not harvested from earlier and an incidental fishery of 3,000 mt. above for the 2010 management season allocations will be released. If the total HG The purpose of the incidental fishery is is 702,204 mt. or these apportionment levels for Pacific to allow for the restricted incidental 2. Cutoff. This is the biomass level sardine are reached at any time, the Pacific landings of Pacific sardine in other below which no commercial fishery is sardine fishery is closed until either it re- fisheries, particularly other CPS allowed. The FMP established this level opens per the allocation scheme or the fisheries, if and when a seasonal at 150,000 mt. beginning of the next fishing season. There directed fishery is closed. 3. Distribution. The portion of the is no limit on the amount of catch that any The directed harvest levels and Pacific sardine biomass estimated in the single vessel can take during an allocation incidental set-aside would be initially EEZ off the Pacific coast is 87 percent period or the year; the HG and seasonal allocations are available until fully utilized allocated across the three seasonal and is based on the average historical by the entire CPS fleet. allocation periods in the following way: larval distribution obtained from The small entities that would be affected January 1–June 30, 22,463 mt would be scientific cruises and the distribution of by the proposed action are the vessels that allocated for directed harvest with an the resource according to the logbooks compose the West Coast CPS finfish fleet. incidental set aside of 1,000 mt; July 1– of aerial fish-spotters. Approximately 109 vessels are permitted to September 14, 25,861 mt would be 4. Fraction. The harvest fraction is the operate in the sardine fishery component of allocated for directed harvest with an percentage of the biomass above 150,000 the CPS fishery off the U.S. West Coast; 65 incidental set aside of 1,000 mt; mt that may be harvested. The fraction permits in the Federal CPS limited entry September 15–December 31, 11,760 mt used varies (5–15 percent) with current fishery off California (south of 39 N. lat.), and would be allocated for directed harvest ocean temperatures; a higher fraction for a combined 44 permits in Oregon and Washington’s state Pacific sardine fisheries. with an incidental set aside of 1,000 mt. warmer ocean temperatures and a lower This proposed rule has an equal effect on all If during any of the seasonal allocation fraction for cooler temperatures. of these small entities and therefore will periods the applicable adjusted directed Warmer ocean temperatures favor the impact a substantial number of these small harvest allocation is projected to be production of Pacific sardine. For 2010, entities in the same manner. These vessels taken, fishing would be closed to the fraction used was 15 percent, based are considered small business entities by the

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U.S. Small Business Administration since the the entire 2010 HG, and assuming a such conditions in its own way, not all CPS vessels do not have annual receipts in excess coastwide average ex-vessel price per mt of stocks are likely to be abundant at the same of $4.0 million. Therefore, there would be no $187, the potential revenue to the fleet would time; therefore as abundance levels and economic impacts resulting from be approximately $13.5 million. This would markets fluctuate, the CPS fishery as a whole disproportionality between small and large be higher than average coastwide ex-vessel has endured by depending on a group of business entities under the proposed action. value achieved from 2002–2009. Whether The profitability of these vessels as a result this will occur depends greatly on market species. of this proposed rule is based on the average forces within the fishery and on the regional Based on the disproportionality and Pacific sardine ex-vessel price per mt. NMFS availability of the resource to the fleets and profitability analysis above, this rule if used average Pacific sardine ex-vessel price the fleets’ ability to find pure schools of adopted, will not have a significant economic per mt to conduct a profitability analysis Pacific sardine. A change in the market and/ impact on a substantial number of these because cost data for the harvesting or the potential lack of availability of the small entities. operations of CPS finfish vessels was resource to the fleets could cause a reduction unavailable. in the amount of Pacific sardine that is As a result, an Initial Regulatory For the 2009 fishing year the maximum HG harvested, in turn, reducing the total revenue Flexibility Analysis is not required and was set at 66,932 mt. The majority of the HG to the fleet from Pacific sardine. none has been prepared. was harvested during the 2009 fishing season However, the revenue derived from This action does not contain a with an estimated coastwide ex-vessel value harvesting Pacific sardine is only one factor of $12.5 million. Although the 2009 HG was determining the overall revenue of a majority collection-of-information requirement 25 percent lower than the HG for 2008, due of the CPS fleet and therefore the economic for purposes of the Paper Reduction Act. to an increase in ex-vessel price per pound impact to the fleet from the proposed action Authority: 16 U.S.C. 1801 et seq. of sardine, coastwide ex-vessel revenue for can not be viewed in isolation. CPS finfish 2009 was less than $2 million different than vessels typically harvest a number of other Dated: January 7, 2010. revenue for 2008 and above the average ex- species, including anchovy, mackerel, squid, Samuel D. Rauch III, vessel revenue achieved from 2002–2007. and tuna, making Pacific sardine only one Deputy Assistant Administrator for The proposed HG for the 2010 Pacific component of a multi-species CPS fishery. A Regulatory Programs, National Marine sardine fishing season (January 1, 2010 reliance on multiple species is a necessity Fisheries Service. through December 31, 2010) is 72,039 mt. because each CPS stock is highly associated This HG is slightly higher than the HG for to present ocean and environmental [FR Doc. 2010–496 Filed 1–12–10; 8:45 am] 2009 of 66,932 mt. If the fleet were to take conditions. Because each species responds to BILLING CODE 3510–22–S

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Notices Federal Register Vol. 75, No. 8

Wednesday, January 13, 2010

This section of the FEDERAL REGISTER articulate the reviewer’s concerns and Approximately five miles of road contains documents other than rules or contentions. would be built then obliterated proposed rules that are applicable to the Comments received in response to immediately following timber removal. public. Notices of hearings and investigations, this solicitation, including names and Commercial harvest and road committee meetings, agency decisions and addresses of those who comment, will rulings, delegations of authority, filing of construction would not occur in the two petitions and applications and agency be part of the public record for this roadless areas. proposed action. Comments submitted statements of organization and functions are Post treatment activities would anonymously will be accepted and examples of documents appearing in this include underburning, site preparation considered, however. section. burning, jackpot burning, hand piling/ FOR FURTHER INFORMATION CONTACT: burning, tree planting, and monitoring Amber Kamps at 406–362–7000. of natural regeneration. DEPARTMENT OF AGRICULTURE Individuals who use telecommunication devices for the deaf In all the areas proposed, the opening Forest Service (TDD) may call the Federal Information size may exceed 40 acres due to the amount of mortality created by the bark Helena National Forest, Montana, Relay Service (FIRS) at 1–800–877–8339 beetles and the resulting need for Stonewall Vegetation Project between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday. regeneration. AGENCY: Forest Service, USDA. SUPPLEMENTARY INFORMATION: Responsible Official ACTION: Notice of intent to prepare an Purpose and Need for Action environmental impact statement. Helena National Forest Supervisor. The landscape in this project area has SUMMARY: The Helena National Forest is become a more uniform dense forest Nature of Decision To Be Made going to prepare an environmental susceptible to insect and wildfire The decisions to be made include: impact statement for vegetation mortality. The mountain pine beetle has Whether to implement the proposed management actions north and west of caused widespread tree mortality. These action or an alternative to the proposed the community of Lincoln, MT. Fire conditions have elevated the fuel levels, suppression and moist growing which in turn pose a threat to nearby action, what monitoring requirements conditions through much of this century homes and communities in the wildland would be appropriate to evaluate the resulted in a loss of open forest urban interface. The purpose and need implementation of this project, and conditions and seral species (aspen, for this project includes: improving the whether a forest plan amendment would ponderosa pine and western larch). This mix of vegetation and structure across be necessary as a result of the decision has created a more uniform landscape the landscape so that it is diverse, for this project. comprised of dense forests susceptible resilient, and sustainable to wildfire and Scoping Process to insect and wildfire mortality insects; modifying fire behavior to (Douglas-fir and lodgepole pine). In enhance community protection while This notice of intent initiates the addition, a large-scale mountain pine creating conditions that allow the scoping process, which guides the beetle epidemic has killed most of the reestablishment of fire as a natural development of the environmental mature lodgepole pine and ponderosa process on the landscape; enhancing impact statement. In January 2010, a pine. These conditions are elevating fuel and restoring aspen, western larch and scoping package will be mailed, an open levels which pose a wildfire threat to ponderosa pine species and habitats; house will be scheduled, and Web site nearby homes and communities in the utilizing the economic value of trees information will be posted. wildland urban interface (WUI). through removal; and integrating It is important that reviewers provide DATES: Comments concerning the scope restoration with socioeconomic their comments at such times and in of the analysis must be received by considerations. February 12, 2010. The draft such manner that they are useful to the environmental impact statement is Proposed Action agency’s preparation of the expected August 2010 and the final Approximately 8,600 acres are environmental impact statement. environmental impact statement is proposed for treatment. The proposed Therefore, comments should be expected January 2011. action includes using both commercial provided prior to the close of the ADDRESSES: Send written comments to and noncommercial treatments to comment period and should clearly Amber Kamps, Helena National Forest, achieve the desired condition. These articulate the reviewer’s concerns and 1569 Hwy. 200, Lincoln, MT 59639. actions would include: Regeneration contentions. The submission of timely Comments may also be sent via e-mail harvests, intermediate harvests, and specific comments can affect a to [email protected], precommercial thinnings, and reviewer’s ability to participate in or via facsimile to 406–449–5436. prescribed burning. Implementing the subsequent administrative appeal or It is important that reviewers provide proposed action could include the use judicial review. their comments at such times and in of chainsaws, feller bunchers, and cable Dated: January 6, 2010. such a way that they are useful to the logging equipment. Agency’s preparation of the EIS. The proposed action also includes Kevin T. Riordan, Therefore, comments should be using prescribed fire and tree slashing Forest Supervisor. provided prior to the close of the in two roadless areas (Bear Marshall [FR Doc. 2010–452 Filed 1–12–10; 8:45 am] comment period and should clearly Scapegoat Swan and Lincoln Gulch). BILLING CODE 3410–11–P

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DEPARTMENT OF AGRICULTURE Dated: January 6, 2010. Inspection Service has received a Lenise Lago, petition from Syngenta Biotechnology, Forest Service Deputy Regional Forester, Pacific Northwest Inc., seeking a determination of Region. nonregulated status for corn designated Notice of Meeting; Federal Lands [FR Doc. 2010–440 Filed 1–12–10; 8:45 am] as transformation event MIR162, which Recreation Enhancement Act (Title VIII, BILLING CODE 3410–11–M has been genetically engineered for Pub. L. 108–447) insect resistance. The petition has been submitted in accordance with our AGENCY: Pacific Northwest Region, DEPARTMENT OF AGRICULTURE regulations concerning the introduction Forest Service, USDA. of certain genetically engineered ACTION: Notice of Meeting. Forest Service organisms and products. In accordance with those regulations, we are soliciting Eastern Washington Cascades SUMMARY: The Pacific Northwest Provincial Advisory Committee and the comments on whether this genetically Recreation Resource Advisory Yakima Provincial Advisory Committee engineered corn is likely to pose a plant Committee will meet via a conference pest risk. We are also making available call. The purpose of the meeting is to AGENCY: Forest Service, USDA. for public comment an environmental review and provide recommendations ACTION: Notice of Meeting. assessment for the proposed on recreation fee proposals for facilities determination of nonregulated status. SUMMARY: and services offered on lands managed The Eastern Washington DATES: We will consider all comments by the Forest Service and Bureau of Cascades Provincial Advisory we receive on or before March 15, 2010. Committee and the Yakima Provincial Land Management in Oregon and ADDRESSES: You may submit comments Washington, under the Federal Lands Advisory Committee will meet on February 3, 2010 at the Okanogan- by either of the following methods: Recreation Enhancement Act of 2004. ∑ Federal eRulemaking Portal: Go to Wenatchee National Forest (http://www.regulations.gov/ DATES: The conference call will be held Headquarters office, 215 Melody Lane, fdmspublic/component/ on February 2, 2010 from 12:30 p.m. to Wenatchee, WA. During this meeting main?main=DocketDetail&d=APHIS– 4:30 p.m. A public input session will be information will be shared about provided at 1 p.m. on February 2, 2010. Holden Mine clean-up operations, 2009–0072) to submit or view comments Comments will be limited to three Stehekin River Corridor Implementation and to view supporting and related minutes per person. Plan/Environmental Impact Statement, materials available electronically. ∑ Postal Mail/Commercial Delivery: and Bureau of Land Management ADDRESSES: Individuals wishing to Please send two copies of your comment Resource Management Plan update. All participate in the conference call or to Docket No. APHIS–2009–0072, Eastern Washington Cascades and provide public comment should contact Regulatory Analysis and Development, Jocelyn Biro, Recreation Program Yakima Province Advisory Committee meetings are open to the public. PPD, APHIS, Station 3A–03.8, 4700 Coordinator (503) 808–2411 or River Road Unit 118, Riverdale, MD FOR FURTHER INFORMATION CONTACT: [email protected]. Send written comments 20737–1238. Please state that your Direct questions regarding this meeting to Dan Harkenrider, Designated Federal comment refers to Docket No. APHIS– to Becki Heath, Designated Federal Official for the Pacific Northwest 2009–0072. Recreation RAC, 902 Wasco Street, Suite Official, USDA, Okanogan-Wenatchee Reading Room: You may read any 200, Hood River, OR 97031, 541–308– National Forest, 215 Melody Lane, comments that we receive on this 1700 or [email protected]. Wenatchee, Washington 98801, phone docket in our reading room. The reading 509–664–9200. FOR FURTHER INFORMATION CONTACT: Dan room is located in room 1141 of the Dated: January 6, 2010. Harkenrider, Designated Federal USDA South Building, 14th Street and Official, 902 Wasco Street, Suite 200, Rebecca Lockett Heath, Independence Avenue SW., Hood River, OR 97031, 541–308–1700. Designated Federal Official, Okanogan- Washington, DC. Normal reading room Wenatchee National Forest. hours are 8 a.m. to 4:30 p.m., Monday SUPPLEMENTARY INFORMATION: The [FR Doc. 2010–513 Filed 1–12–10; 8:45 am] through Friday, except holidays. To be meeting is open to the public. BILLING CODE 3410–11–P sure someone is there to help you, Recreation RAC discussion is limited to please call (202) 690–2817 before Forest Service and Bureau of Land coming. Management staff and Recreation RAC DEPARTMENT OF AGRICULTURE Other Information: Additional members. However, persons who wish information about APHIS and its to bring recreation fee matters to the Animal and Plant Health Inspection programs is available on the Internet at attention of the Committee may file Service (http://www.aphis.usda.gov). written statements with the Committee [Docket No. APHIS–2009–0072] FOR FURTHER INFORMATION CONTACT: Dr. staff before or after the meeting. A Subray Hegde, Biotechnology public input session will be provided Syngenta Biotechnology, Inc.; Regulatory Services, APHIS, 4700 River and individuals who have made written Availability of Petition and Road Unit 147, Riverdale, MD 20737– requests by January 29, 2010, to the Environmental Assessment for 1236; (301) 734–0810, email: Designated Federal Official will have Determination of Nonregulated Status ([email protected]). To the opportunity to address the for Corn Genetically Engineered for obtain copies of the petition, draft Committee during the meeting on Insect Resistance environmental assessment or plant pest February 2, 2010, at 1 p.m. AGENCY: Animal and Plant Health risk assessment, contact Ms. Cindy Eck The Recreation RAC is authorized by Inspection Service, USDA. at (301) 734–0667, email: the Federal Land Recreation ACTION: Notice. ([email protected]). Those Enhancement Act, which was signed documents are also available on the into law by President Bush in December SUMMARY: We are advising the public Internet at (http://www.aphis.usda.gov/ 2004. that the Animal and Plant Health brs/aphisdocs/07_25301p.pdf), (http://

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www.aphis.usda.gov/brs/aphisdocs/ is also driven by the ZmUbilnt APHIS oversight. APHIS is considering 07_25301p_pea.pdf) and (http:// promoter, and uses the Nopaline the following alternatives: (1) Take no www.aphis.usda.gov/brs/aphisdocs/ Synthase (NOS) gene from action, i.e., APHIS would not change the 07_25301p_pra.pdf). Agrobacterium tumefaciens as a regulatory status of the MIR162 corn SUPPLEMENTARY INFORMATION: terminator sequence. All of these line and it would continue to be a sequences are well-characterized and regulated article, or (2) grant Background are non-coding regulatory regions only. nonregulated status to corn line MIR162 The regulations in 7 CFR part 340, Therefore, these sequences will not in whole. ‘‘Introduction of Organisms and cause the MIR162 corn line to promote In § 403 of the Plant Protection Act (7 ‘‘ ’’ Products Altered or Produced Through plant disease. U.S.C. 7701 et seq.), plant pest is Genetic Engineering Which Are Plant A single copy of these genes and other defined as any living stage of any of the Pests or Which There Is Reason to DNA regulatory sequences were following that can directly or indirectly introduced into the corn genome with injure, cause damage to, or cause Believe Are Plant Pests,’’ regulate, the transformation vector pNOV1300 disease in any plant or plant product: A among other things, the introduction using disarmed (non-plant pest causing) protozoan, a nonhuman animal, a (importation, interstate movement, or A. tumefaciens transformation. Plant parasitic plant, a bacterium, a fungus, a release into the environment) of cells containing the introduced DNA virus or viroid, an infectious agent or organisms and products altered or were selected by culturing them in sugar other pathogen, or any article similar to produced through genetic engineering mannose. After the initial or allied with any of the foregoing. that are plant pests or that there is transformation, the antibiotic The MIR162 corn line is subject to reason to believe are plant pests. Such cefotoxime was included in the culture regulation by other Federal agencies. genetically engineered organisms and medium to kill any remaining The U.S. Environmental Protection ‘‘ products are considered regulated Agrobacterium. Therefore, no part of the Agency (EPA) is responsible for the ’’ articles. plant pest A. tumefaciens remained in regulation of pesticides under the The regulations in § 340.6(a) provide Syngenta MIR162 corn due to the Federal Insecticide, Fungicide, and that any person may submit a petition transformation method. Rodenticide Act (FIFRA), as amended (7 to the Animal and Plant Health Syngenta’s MIR162 corn line has been U.S.C. 136 et seq.). FIFRA requires that Inspection Service (APHIS) seeking a considered a regulated article under the all pesticides, including herbicides, be determination that an article should not regulations in 7 CFR part 340 because it registered prior to distribution or sale, be regulated under 7 CFR part 340. contains gene sequences from plant unless exempt from EPA regulation. In Paragraphs (b) and (c) of § 340.6 pathogens. The MIR162 corn line has order to be registered as a pesticide describe the form that a petition for a been field tested in the United States under FIFRA, it must be demonstrated determination of nonregulated status since 1999 as authorized by USDA that when used with common practices, must take and the information that must APHIS notifications and permits (see a pesticide will not cause unreasonable be included in the petition. appendix A of the petition). In the adverse effects in the environment. On September 10, 2007, APHIS process of reviewing the permits for Under the Federal Food, Drug, and received a petition seeking a field trials of the subject corn, APHIS Cosmetic Act (FFDCA), as amended (21 determination of nonregulated status determined that the vectors and other U.S.C. 301 et seq.), pesticides added to (APHIS Petition Number 07–253–01p) elements used to introduce the new (or contained in) raw agricultural from Syngenta Biotechnology, Inc., of genes were disarmed and that the trials, commodities generally are considered to Research Triangle Park, NC (Syngenta), which were conducted under conditions be unsafe unless a tolerance or for corn (Zea mays L.) designated as of reproductive and physical exemption from tolerance has been transformation event MIR162, which confinement or isolation, would not established. Residue tolerances for has been genetically engineered for present a risk of plant pest introduction pesticides are established by EPA under insect resistance, stating that corn line or dissemination. the FFDCA, and the U.S. Food and Drug MIR162 is unlikely to pose a plant pest Field tests conducted under USDA Administration (FDA) enforce the risk and, therefore, should not be a APHIS oversight allowed for evaluation tolerances set by EPA. Syngenta regulated article under APHIS’ in a natural agricultural setting while submitted the appropriate regulatory regulations in 7 CFR part 340. imposing measures to minimize the risk package to EPA on November 2, 2007, As described in the petition, the of persistence in the environment after seeking an exemption from the MIR162 corn line has been genetically completion of the test. Data are gathered requirement of a tolerance for residues engineered to express the VIP3Aa20 on multiple parameters and used by the from the Vip3Aa20 protein from B. protein. The VIP3Aa20 gene is based on applicant to evaluate agronomic thuringiensis. On August 6, 2008, EPA the sequences from Bacillus characteristics and product granted the exemption. thuringiensis, a common soil bacterium. performance. These data are used by FDA’s policy statement concerning The VIP3Aa20 gene confers tolerance to APHIS to determine if the new variety regulation of products derived from new certain lepidopteran (caterpillar) pests poses a plant pest risk. Syngenta has plant varieties, including those of corn. Expression of the VIP3Aa20 petitioned APHIS to make a genetically engineered, was published gene is driven by the corn ubiquitin determination that the MIR162 corn line in the Federal Register on May 29, 1992 promoter (ZmUbilnt), and uses the and the progeny derived from its crosses (57 FR 22984–23005). Under this policy, terminator sequence from 35S RNA of with other nonregulated corn shall no FDA uses what is termed a consultation cauliflower mosaic virus (CaMV). longer be considered regulated articles process to ensure that human and MIR162 corn also contains the manA under 7 CFR part 340. animal feed safety issues or other gene from E. coli, which encodes the APHIS has prepared an regulatory issues (e.g., labeling) are enzyme phosphomannose isomerase environmental assessment (EA) in resolved prior to commercial (PMI), and was used only as a selectable which it presents two alternatives based distribution of a bioengineered food. In marker during transformant selection on its analyses of data submitted by compliance with the FDA policy, and confers no other benefits to the Syngenta, a review of other scientific Syngenta submitted a food and feed transformed corn plant. The manA gene data, and field tests conducted under safety and nutritional assessment

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summary to FDA for their MIR162 corn Authority: 7 U.S.C. 7701–7772 and 7781– authority to investigate allegations of line in 2007. FDA completed their 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and voting irregularities even when alleged consultation on MIR 162 corn on 371.3. abuses do not involve discrimination. Done in Washington, DC, this 6th day December 9, 2008, concluding that FDA CONTACT PERSON FOR FURTHER of January 2010. had ‘‘no further questions concerning INFORMATION: Lenore Ostrowsky, Acting grain and forage derived from corn Cindy Smith Chief, Public Affairs Unit (202) 376– event MIR162.’’ Administrator, Animal and Plant Health 8591. TDD: (202) 376–8116. National Environmental Policy Act Inspection Service. Persons with a disability requiring [FR Doc. 2010–407 Filed 1–12–10: 2:16 pm] special services, such as an interpreter A draft EA has been prepared to BILLING CODE 3410–34–S for the hearing impaired, should contact provide the APHIS decisionmaker with Pamela Dunston at least seven days a review and analysis of any potential prior to the scheduled date of the environmental impacts associated with COMMISSION ON CIVIL RIGHTS hearing at 202–376–8105. TDD: (202) the proposed determination of 376–8116. nonregulated status for the MIR162 corn Hearing on the Department of Justice’s Dated: January 8, 2010. line. The draft EA was prepared in Actions Related to the New Black David Blackwood, Panther Party Litigation and Its accordance with (1) the National General Counsel. Enforcement of Section 11(b) of the Environmental Policy Act of 1969 [FR Doc. 2010–497 Filed 1–12–10; 8:45 am] (NEPA), as amended (42 U.S.C. 4321 et Voting Rights Act BILLING CODE 6335–01–P seq.), (2) regulations of the Council on AGENCY: United States Commission on Environmental Quality for Civil Rights. implementing the procedural provisions ACTION: Notice of hearing. DEPARTMENT OF COMMERCE of NEPA (40 CFR parts 1500–1508), (3) USDA regulations implementing NEPA DATE AND TIME: Friday, February 12, International Trade Administration (7 CFR part 1b), and (4) APHIS’ NEPA 2010; 9:30 a.m. EST. Implementing Procedures (7 CFR part [A–489–815] PLACE: U.S. Commission on Civil 372). Rights, 624 Ninth Street, NW., Room Light–Walled Rectangular Pipe and In accordance with § 340.6(d) of the 540, Washington, DC 20425. Tube from Turkey: Extension of Time regulations, we are publishing this SUMMARY: Notice is hereby given Limits for Preliminary Results of notice to inform the public that APHIS pursuant to the provisions of the Civil Antidumping Duty Administrative will accept written comments regarding Rights Commission Amendments Act of Review the petition for a determination of 1994, 42 U.S.C. 1975a, and 45 CFR AGENCY: nonregulated status from interested or 702.3, that public hearings before the Import Administration, affected persons for a period of 60 days U.S. Commission on Civil Rights will International Trade Administration, from the date of this notice. We are also commence on Friday, February 12, Department of Commerce. soliciting written comments from 2010, beginning at 9:30 a.m. EST in EFFECTIVE DATE: January 13, 2010. interested or affected persons on the Washington, DC at the Commission’s FOR FURTHER INFORMATION CONTACT: draft EA prepared to examine any offices located at 624 Ninth Street, NW., Tyler Weinhold or Robert James, Import potential environmental impacts of the Room 540, Washington, DC 20425. An Administration, International Trade proposed determination for the executive session not open to the public Administration, U.S. Department of deregulation of the subject corn line, may be convened at any appropriate Commerce, 14th Street and Constitution and the plant pest risk assessment. The time before or during the hearing. Avenue, NW, Washington DC 20230; petition, draft EA, and plant pest risk The purpose of this hearing is to telephone: (202) 482–1121 and (202) assessment are available for public collect information within the 482–0649, respectively. review, and copies of the petition, draft jurisdiction of the Commission, under SUPPLEMENTARY INFORMATION: EA, and plant pest risk assessment are 42 U.S.C. 1975a, related particularly to available as indicated under ADDRESSES the Department of Justice’s actions in Background FOR FURTHER INFORMATION CONTACT and the New Black Panther Party Litigation At the request of interested parties, on above. and enforcement of Section 11(b) of the June 24, 2009, the Department After the comment period closes, Voting Rights Act. published in the Federal Register a APHIS will review all written comments The Commission is authorized to hold notice of initiation of this antidumping received during the comment period hearings and to issue subpoenas for the duty administrative review. See and any other relevant information. All production of documents and the Initiation of Antidumping and public comments received regarding the attendance of witnesses pursuant to 45 Countervailing Duty Administrative petition, draft EA, and plant pest risk CFR 701.2. The Commission is an Reviews and Requests for Revocation in assessment will be available for public independent bipartisan, fact finding Part, 74 FR 30052, August 25, 2009. The review. After reviewing and evaluating agency authorized to study, collect, and review covers the period January 30, the comments on the petition, the draft disseminate information, and to 2008, through April 30, 2009. The EA, plant pest risk assessment and other appraise the laws and policies of the preliminary results for this data, APHIS will furnish a response to Federal Government, and to study and administrative review is currently due the petitioner, either approving or collect information with respect to no later than January 31, 2010. denying the petition. APHIS will then discrimination or denials of equal publish a notice in the Federal Register protection of the laws under the Extension of Time Limits for announcing the regulatory status of the Constitution because of race, color, Preliminary Results MIR162 corn line and the availability of religion, sex, age, disability, or national Section 751(a)(3)(A) of the Tariff Act APHIS’ written regulatory and origin, or in the administration of of 1930, as amended (the Act), requires environmental decision. justice. The Commission has broad the Department to complete the

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preliminary results of an administrative (AFSC), 7600 Sand Point Way NE, DEPARTMENT OF COMMERCE review within 245 days after the last day Building 4, NMML conference room of the anniversary month of an order for (room 2039), Seattle, WA. National Oceanic and Atmospheric Administration which a review is requested. However, Council address: North Pacific if it is not practicable to complete the Fishery Management Council, 605 W. RIN 0648–XT67 review within these time periods, 4th Ave., Suite 306, Anchorage, AK section 751(a)(3)(A) of the Act allows 99501–2252. New England Fishery Management the Department to extend the 245 day Council; Public Meeting time period for the preliminary results FOR FURTHER INFORMATION CONTACT: up to 365 days. Diana Evans, Council staff, telephone: AGENCY: National Marine Fisheries The Department has determined it is (907) 271–2809. Service (NMFS), National Oceanic and not practicable to complete this review Atmospheric Administration (NOAA), within the statutory time limit because SUPPLEMENTARY INFORMATION: The Commerce. we require additional time to collect agenda is as follows: ACTION: Notice of a public meeting. and analyze information needed for our AI Ecosystem Team agenda (January SUMMARY: The New England Fishery preliminary results. Accordingly, the 27–28): Department is extending the time limits Management Council (Council) will for completion of the preliminary Review new information on AI hold a 3-day Council meeting to results of this administrative review ecosystem; Review FEP interactions and consider actions affecting New England fisheries in the exclusive economic zone until no later than May 31, 2010, which update as appropriate; Plan for further (EEZ). is 365 days from the last day of the updates and amendments to the FEP. anniversary month of these orders. We DATES: The meeting will be held on intend to issue the final results in this Joint Ecosystem Committee and AI Tuesday, January 26 through Thursday, review no later than 120 days after Ecosystem Team agenda (January 28, 1– January 28, 2010. The meeting will publication of the preliminary results. 5 p.m.): begin at 8:30 a.m. on each of the 3 This notice is issued and published in meeting days. Discuss AI Fishery Ecosystem Plan accordance with sections 751(a)(3)(A) ADDRESSES: The meeting will be held at updates, and further action; Discuss and 777(i)(1) of the Act. the Sheraton Harborside Hotel, 250 NOAA’s marine spatial planning Market Street, Portsmouth, NH 03801; Dated: January 7, 2010. framework, and provide John M. Andersen, telephone: (603) 431–2300 and fax: recommendations for the Council. (603) 433–5649. Acting Deputy Assistant Secretary for The Agenda is subject to change, and Antidumping and Countervailing Duty Council address: New England Operations. the latest version will be posted at Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. [FR Doc. 2010–493 Filed 1–12–10; 8:45 am] http://www.alaskafisheries.noaa.gov/ npfmc/ FOR FURTHER INFORMATION CONTACT BILLING CODE 3510–DS–S : Paul Although non-emergency issues not J. Howard, Executive Director, New contained in this agenda may come England Fishery Management Council; DEPARTMENT OF COMMERCE before this group for discussion, in telephone: (978) 465–0492. accordance with the Magnuson-Stevens SUPPLEMENTARY INFORMATION: National Oceanic and Atmospheric Fishery Conservation and Management Tuesday, January 26, 2010 Administration Act (Magnuson-Stevens Act), those RIN 0648–XT68 issues may not be the subject of formal Following introductions and any action during this meeting. Actions will announcements, the Council will North Pacific Fishery Management be restricted to those issues specifically receive a series of brief reports from the Council; Public Meeting identified in this notice and any issues Council Chairman and Executive Director, the NOAA Fisheries Northeast AGENCY: National Marine Fisheries arising after publication of this notice that require emergency action under Regional Administrator, Northeast Service (NMFS), National Oceanic and Fisheries Science Center and Mid- Section 305(c) of the Magnuson-Stevens Atmospheric Administration (NOAA), Atlantic Fishery Management Council Act, provided the public has been Commerce. liaisons, NOAA General Counsel, notified of the Council’s intent to take ACTION: Notice of public meetings of the representatives of the U.S. Coast Guard North Pacific Fishery Management final action to address the emergency. and the Atlantic States Marine Fisheries Council Ecosystem Committee. Special Accommodations Commission, as well as NOAA Enforcement. These reports will be SUMMARY: The North Pacific Fishery These meetings are physically followed by a review of any Management Council (Council) Aleutian accessible to people with disabilities. experimental fishery permit Islands Fishery Ecosystem Plan Team Requests for sign language applications that have been received (AI Ecosystem Team) will meet in interpretation or other auxiliary aids since the last Council meeting. During Seattle, WA, in the NMML conference should be directed to Gail Bendixen at the morning session the Council also room (room 2039), from 9 a.m. to 5 p.m., (907) 271–2809 at least 7 working days will review sector implementation as January 27–28, 2010. The Council’s prior to the meeting date. developed in the Northeast Multispecies Ecosystem Committee will meet jointly (Groundfish) Fishery Management Plan Dated: January 7, 2010. with the AI Ecosystem Team on January (FMP) as part of a report to be provided 28 from 1 p.m. to 5 p.m. Tracey L. Thompson, by the National Marine Fisheries DATES: The meetings will be held on Acting Director, Office of Sustainable Service Regional Office staff from January 27–28, 2010. Fisheries, National Marine Fisheries Service. Gloucester, MA. After a lunch break, the ADDRESSES: The meetings will be held at [FR Doc. 2010–401 Filed 1–12–10; 8:45 am] Council will review and provide the Atlantic Fisheries Science Center BILLING CODE 3510–22–S feedback to the Northeast Fisheries

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Science Center on their performance and accountability measures, and ADDRESSES: The Review Workshop will monitoring and evaluation plan possibly a total allowable catch for the be held at the Hilton Garden Inn, 5265 concerning existing and future catch fleet. The day will conclude with an International Boulevard, North share programs. The Council’s Herring open period for public comments about Charleston, SC 29418; (800) 782–9444 or Committee will present an overview of items not listed on the agenda but (843) 308–9330. the management measures proposed in related to Council business and any Amendment 4 to the Atlantic Herring other outstanding issues that were FOR FURTHER INFORMATION CONTACT: Dale FMP, including the establishment of postponed until the end of the meeting. Theiling, SEDAR Coordinator, 4055 annual catch limits and accountability Although other non-emergency issues Faber Place Drive, Suite 201, North measures, and select final measures not contained in this agenda may come Charleston, SC 29405; (843) 571–4366. before submitting the action to NMFS. before this Council for discussion, those SUPPLEMENTARY INFORMATION: The Gulf NOAA leadership will present a briefing issues may not be the subjects of formal of Mexico, South Atlantic, and on its Catch Shares Policy and conduct action during this meeting. Council Caribbean Fishery Management a question and answer session following action will be restricted to those issues Councils, in conjunction with NOAA the presentation. specifically listed in this notice and any Fisheries and the Atlantic and Gulf issues arising after publication of this Wednesday, January 27, 2010 States Marine Fisheries Commissions notice that require emergency action have implemented the Southeast Data, The second day of the Council under section 305(c) of the Magnuson- meeting will begin with a discussion Stevens Act, provided that the public Assessment and Review (SEDAR) about and possible reconsideration of has been notified of the Council’s intent process, a multi-step method for Framework 21 to the Atlantic Sea to take final action to address the determining the status of fish stocks in Scallop FMP. Pending the outcome of emergency. the Southeast Region. The SEDAR 20 this agenda item, the Council also may Review Workshop will be an revisit Framework 44 to the Northeast Special Accommodations independent peer review of the Multispecies FMP to change the This meeting is physically accessible products from assessments of Atlantic yellowtail flounder allocation to the to people with disabilities. Requests for stocks of croaker and menhaden scallop fleet in that action. Later, the sign language interpretation or other conducted by the Atlantic States Marine Groundfish Committee will ask for auxiliary aids should be directed to Paul Fisheries Commission (ASMFC). approval of alternative rebuilding J. Howard (see ADDRESSES) at least 5 Products to be reviewed are reports from strategy options for the Georges Bank days prior to the meeting date. the ASMFC Data Workshop and ASMFC yellowtail flounder stock. The Chairman of the Scientific and Statistical Dated: January 11, 2010. Stock Assessment Workshop for each Committee (SSC) will report on the Tracey L. Thompson, stock. The Data Workshop Reports committee’s comments concerning a Acting Director, Office of Sustainable compile and evaluate potential datasets model developed by the Habitat Plan Fisheries, National Marine Fisheries Service. and recommend which datasets are Development Team (PDT) to analyze [FR Doc. 2010–623 Filed 1–12–10; 8:45 am] appropriate for assessment analyses. alternatives to minimize adverse BILLING CODE 3510–22–S The Stock Assessment Workshop impacts of fishing activities. The SSC Reports describe the fisheries, evaluate also will report on the process-related the status of the stock, estimate issues addressed at the last SSC meeting DEPARTMENT OF COMMERCE biological benchmarks, project future as well as the comments of SSC population conditions, and recommend members on the published proposed National Oceanic and Atmospheric research and monitoring needs. The rule concerning practices and Administration product of the Review Workshop is a procedures related to National Standard Peer Review Evaluation Report 2. The Habitat Committee will RIN 0648–XT69 documenting Panel opinions regarding comment, where appropriate, about the the strengths and weaknesses of the Fisheries of the Atlantic; Southeast model developed by its PDT, as well as stock assessment and input data. Data, Assessment, and Review on President Obama’s Interagency Participants for the SEDAR 20 Review Ocean Policy Task Force Report: Interim (SEDAR); Atlantic croaker and Atlantic menhaden; Public Meetings Workshop are appointed by the Atlantic Framework for Effective Coastal and States Marine Fisheries Commissions, Marine Spatial Planning. AGENCY: National Marine Fisheries NOAA Fisheries Southeast Fisheries Thursday, January 28, 2010 Service (NMFS), National Oceanic and Science Center, and the NOAA Center The Council will begin the last day of Atmospheric Administration (NOAA), for Independent Experts. Review the meeting with a discussion of several Commerce. Workshop participants may include outstanding issues related to work ACTION: Notice of SEDAR Review data collectors and database managers; priorities for 2010. The Northeast Workshop for Atlantic croaker and stock assessment scientists, biologists, Fisheries Science Center staff will Atlantic menhaden. and researchers; constituency follow with two reports, one on the representatives including fishermen, SUMMARY: status of projected observer days-at-sea The SEDAR assessment environmentalists, and NGO’s; for the upcoming year in accordance review of the Atlantic stocks of croaker international experts; and staff of with the Council’s Standard Bycatch and menhaden will be conducted at a Councils, Commissions, and state and Review Workshop. This is the twentieth Reporting Methodology rules and federal agencies. SUPPLEMENTARY another on the Vessel Calibration SEDAR. See Workshop held late last year. The INFORMATION. Council also intends to approve a range DATES: The Review Workshop will take of alternatives to be analyzed in place March 8–12, 2010. See Amendment 3 to the Red Crab FMP. The SUPPLEMENTARY INFORMATION for specific action will include annual catch limits dates and times.

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SEDAR 20 Workshop Schedule: ADDRESSES: The meetings will be held at Yellowedge Grouper and Tilefish and March 8–12, 2010; SEDAR 20 Review the Battle House, 26 N. Royal Street, Greater Amberjack. 9:20 a.m. - 9:40 a.m. - CLOSED Workshop Mobile, AL 36602. Council address: Gulf of Mexico SESSION (Full Council) - The Scientific March 8, 2010: 1 p.m. - 8 p.m.; March Fishery Management Council, 2203 and Statistical Committee will appoint 9–11, 2010: 8 a.m. - 8 p.m.; March 12, North Lois Avenue, Suite 1100, Tampa, members to the Special Mackerel 2010: 8 a.m. - 1 p.m. FL 33607. Scientific and Statistical Committee. 9:40 a.m. - 10 a.m. - CLOSED The Review Workshop is an FOR FURTHER INFORMATION CONTACT: Dr. Stephen Bortone, Executive Director, SESSION (Full Council) - The Advisory independent peer review of the Panel Selection Committee will appoint assessments developed during the Gulf of Mexico Fishery Management Council; telephone: (813) 348–1630. members to the Mackerel Limited ASMFC Data and Assessment Access Privilege Program Advisory SUPPLEMENTARY INFORMATION: Workshops. Workshop Panelists will Panel. review the assessment and document Council 10 a.m. - 12 p.m. - The Sustainable their comments and recommendations Fisheries/Ecosystem Committee will Wednesday, February 3, 2010 in a Peer Review Evaluation Report. discuss the Options Paper for the Although non-emergency issues not 1 p.m. - The Council meeting will Generic Annual Catch Limit/ contained in this agenda may come begin with a review of the agenda and Accountability Measures Amendment before this group for discussion, those approval of the minutes. and review the proposed National issues may not be the subject of formal 1:15 p.m. - 1:45 p.m. - The Council Standard 2 Guidelines. action during this meeting. Action will will receive a presentation on Catch 1:30 p.m. - 2 p.m. - The Budget be restricted to those issues specifically Shares Task Force. Committee will review the 2010 listed in this notice and any issues 1:45 p.m. - 2:15 p.m. - They will funding. arising after publication of this notice receive a report of the Gulf of Mexico 2 p.m. - 4 p.m. - The Administrative that require emergency action under Alliance activities. Policy Committee will discuss section 305(c) of the Magnuson-Stevens 2:15 p.m. - 4:15 p.m. - They will modifications to Statement of Fishery Conservation and Management receive public testimony on exempted Organization Practice and Procedures Act, provided the public has been fishing permits (EFPs), if any; final and Handbook Development. notified of the Council’s intent to take Regulatory Amendment for Reef Fish 4 p.m. - 4:45 p.m. - The Outreach and final action to address the emergency. Total Allowable Catch; and the Council Education Committee will receive a will hold an open public comment report of the Outreach and Education Special Accommodations period regarding any fishery issue of Advisory Panel meeting. These meetings are physically concern. People wishing to speak before 4:45 p.m. - 5:45 p.m. - The Spiny Lobster/Stone Crab Committee will accessible to people with disabilities. the Council should complete a public discuss the Options Paper for Spiny Requests for sign language comment card prior to the comment Lobster Amendment 10 and approve the interpretation or otherauxiliary aids period. Spiny Lobster SEDAR Terms of should be directed to the Council office 4:15 p.m. - 5:15 p.m. - The Council Reference. (see ADDRESSES) at least 10 business will review and discuss reports from the days prior to the workshop. Sustainable Fisheries/Ecosystem -Recess- Committee. Dated: January 8, 2010 Tuesday, February 2, 2010 Thursday, February 4, 2010 William D. Chappell, 8:30 a.m. - 4 p.m. - The Reef Fish Acting Director, Office of Sustainable 8:30 a.m. - 12:45 p.m. - The Council Management Committee will receive a Fisheries, National Marine Fisheries Service. will review and discuss reports from the presentation on the Red Snapper update [FR Doc. 2010–467 Filed 1–12–10; 8:45 am] committee meetings as follows: Reef assessment; a report from the Standing BILLING CODE 3510–22–S Fish Management; Budget; and Special Reef Fish Scientific and Administrative Policy; Outreach and Statistical Committee; a report from the Education; Spiny Lobster/Stone Crab Red Snapper Advisory Panel; a Draft DEPARTMENT OF COMMERCE Management; Red Drum; Habitat Final Regulatory Amendment for Red Protection; Coastal Migratory Pelagics Snapper Total Allowable Catch; an National Oceanic and Atmospheric (Mackerel) Management; Shrimp Options Paper for Amendment 32 Gag/ Administration Management; Advisory Panel Selection Red Grouper scoping meeting Committee; Scientific and Statistical summaries; a report of the Limited RIN 0648–XT70 Committee Selection Committee; and Access Privilege Program Advisory SEDAR Selection Committee. Panel meeting; a presentation on Gulf of Mexico Fishery Management 12:45 p.m. - 1:15 p.m. - Other Northeast Gulf of Mexico Reserves Council; Public Meetings Business items will follow. Program: Changes in Reef Fish The Council will conclude its meeting Populations; and discuss approval of the AGENCY: National Marine Fisheries at approximately 1:15 p.m. Service (NMFS), National Oceanic and schedules for SEDAR 22 (Yellowedge Atmospheric Administration (NOAA), Committees Grouper and Tilefish) and Greater Commerce. Amberjack updates. Monday, February 1, 2010 4 p.m. - 4:30 p.m. - The Red Drum ACTION: Notice of public meetings. 8:30 a.m. - 9 a.m. - CLOSED SESSION Committee will discuss the Red Drum - The Full Council will receive a Fishery in the Exclusive Economic SUMMARY: The Gulf of Mexico Fishery litigation briefing. Zone. Management Council (Council) will 9 a.m. - 9:20 a.m. - CLOSED SESSION 4:30 p.m. - 5 p.m. - The Habitat convene public meetings. (Full Council) - The SEDAR Selection Protection Committee will give a report DATES: The meetings will be held Committee will appoint members to the of the Mississippi/Louisiana and the February 1 - 4, 2010. SEDAR meetings for Spiny Lobster, Texas Habitat Advisory Panel meetings.

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-Recess- DEPARTMENT OF COMMERCE DEPARTMENT OF COMMERCE

Immediately Following Committee International Trade Administration National Telecommunications and Recess - There will be an informal open Information Administration public question and answer session. [A–570–945] Wednesday, February 3, 2010 [Docket No. 0911201414–0010–02] Prestressed Concrete Steel Wire 8:30 a.m. - 9:30 a.m. - The Shrimp Strand From the People’s Republic of Public Telecommunications Facilities Management Committee will discuss the China: Postponement of Final Program: Notice of Availability of Texas Closure for 2010 from Determination Funds recommendations of the Shrimp AGENCY: National Telecommunications Advisory Panel; report from the AGENCY: Import Administration, and Information Administration, U.S. Standing and Special Shrimp Scientific International Trade Administration, Department of Commerce. and Statistical Committee Meetings and Department of Commerce. a report of Shrimp Effort in 2009. ACTION: Notice of Availability of Funds; DATES: Effective Date: January 13, 2010. Catalog of Federal Domestic Assistance. 9:30 a.m. - 11:30 a.m. - The Coastal FOR FURTHER INFORMATION CONTACT: Migratory Pelagics (Mackerel) SUMMARY: On December 2, 2009, the Management Committee will discuss the Alan Ray or Alexis Polovina, AD/CVD Operations, Office 9, Import National Telecommunications and Coastal Migratory Pelagics Scoping Information Administration (NTIA) Meeting summaries and Options Paper Administration, International Trade Administration, U.S. Department of announced the closing date for receipt for the Coastal Migratory Pelagics of applications for the Public Amendment 18. The committee will Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; Telecommunications Facilities Program also consider a control rule for Gulf telephone: (202) 482–5403 or (202) 482– (PTFP). NTIA now announces that $18 group King and Spanish Mackerel. 3927, respectively. million has been appropriated for fiscal Although other non-emergency issues year (FY) 2010 grants. not on the agendas may come before the Postponement of Final Determination DATES: Funds will be available for Council and Committees for discussion, and Extension of Provisional Measures applications submitted by the originally in accordance with the Magnuson- On December 29, 2009, and January 4, announced deadline of 5 p.m., Eastern Stevens Fishery Conservation and 2010, Xinhua Metal Products Co., Ltd. Standard Time (Closing Time), February Management Act (Magnuson-Stevens (‘‘Xinhua Metals’’) and Wuxi Jinyang 4, 2010, as well as applications for Act), those issues may not be the subject Metal Products Co., Ltd. (‘‘WJMP’’) certain radio applications filed in of formal action during these meetings. requested that pursuant to the response to the Federal Actions of the Council and Committees affirmative preliminary determination Communications Commission (FCC) will be restricted to those issues in this investigation, the Department February 2010 FM Window that must be specifically identified in the agendas postpone its final determination by 60 received prior to 5 p.m., Eastern and any issues arising after publication days under section 735(a)(2) of the Standard Time (Closing Time), February of this notice that require emergency Tariff Act of 1930, as amended (‘‘the 26, 2010. action under Section 305(c) of the Act’’). Xinhua Metals and WJMP also ADDRESSES: To obtain a printed Magnuson-Stevens Act, provided the requested that the Department extend application package, submit completed public has been notified of the Council’s the application of the provisional applications, or send any other intent to take action to address the measures prescribed under 19 CFR correspondence, write to PTFP at the emergency. The established times for 351.210(e)(2) from a 4-month period to following address: NTIA/PTFP, Room addressing items on the agenda may be a 6-month period. In accordance with H–4812, U.S. Department of Commerce, adjusted as necessary to accommodate section 733(d) of the Act and 19 CFR 1401 Constitution Avenue, NW, the timely completion of discussion 351.210(b), because (1) Our preliminary Washington, DC 20230. Application relevant to the agenda items. In order to determination is affirmative, (2) the materials may be obtained electronically further allow for such adjustments and requesting exporters account for a via the Internet at http:// completion of all items on the agenda, significant proportion of exports of the www.ntia.doc.gov/ptfp or http:// the meeting may be extended from, or subject merchandise, and (3) no www.grants.gov. completed prior to the date/time compelling reasons for denial exist, we established in this notice. FOR FURTHER INFORMATION CONTACT: are granting the request and are William Cooperman, Director, Public Special Accommodations postponing the final determination until Broadcasting Division, telephone: (202) no later than 135 days after the 482–5802; fax: (202) 482–2156. These meetings are physically publication of the preliminary Information about the PTFP also can be accessible to people with disabilities. determination notice in the Federal obtained electronically via the Internet Requests for sign language Register, or May 7, 2010. Suspension of at www.ntia.doc.gov/ptfp. interpretation or other auxiliary aids liquidation will be extended should be directed to Tina O’Hern at the accordingly. This determination is SUPPLEMENTARY INFORMATION: On Council (see ADDRESSES) at least 5 issued and published in accordance December 2, 2009, NTIA published a working days prior to the meeting. with section 735(d) of the Act. Notice of Closing Date for Solicitation of Applications for the FY 2010 PTFP Dated: January 8, 2010. Dated: January 7, 2010. grant round (the Notice). The Notice William D. Chappell, Ronald K. Lorentzen, established Thursday, February 4, 2010, Acting Director, Office of Sustainable Deputy Assistant Secretary for Import as the Closing Date for all applications Fisheries, National Marine Fisheries Service. Administration. except those applications that were [FR Doc. 2010–468 Filed 1–12–10; 8:45 am] [FR Doc. 2010–491 Filed 1–12–10; 8:45 am] related to the FCC FM Window. The BILLING CODE 3510–22–S BILLING CODE 3510–DS–P Closing Date for the radio applications

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related to the FM Window1 must be FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF DEFENSE received by Friday, February 26, 2010. Janet S. Taylor, Designated Federal The Notice indicated that: Official, 4301 Jones Bridge Road, Office of the Secretary [i]ssuance of grants is subject to the Bethesda, Maryland 20814; telephone availability of FY 2010 funds. At this 301–295–3066. Ms. Taylor can also National Defense University Board of time, the Congress has passed the provide base access procedures. Visitors (BOV); Open Meeting Further Continuing Appropriations, AGENCY: National Defense University, 2010, to fund operations of the PTFP SUPPLEMENTARY INFORMATION: Meetings of the Board of Regents assure that USU DoD. through December 18, 2009. Further ACTION: Notice of open meeting. notice will be made in the Federal operates in the best traditions of Register about the final status of academia. An outside Board is SUMMARY: The National Defense funding for this program at the necessary for institutional accreditation. University, Designated Federal Officer, appropriate time. Agenda has scheduled a meeting of the Board of On December 16, 2009, the Visitors (BOV). The BOV is a Federal Consolidated Appropriations Act, 2010 The actions that will take place Advisory Board that meets twice a year (the Act) was signed into law.2 The Act include the approval of minutes from in proceedings that are open to the appropriated $18 million for public the Board of Regents Meeting held public. telecommunications facilities planning November 5, 2009; acceptance of reports DATES: The meeting will be held on and construction grants. These funds are from working committees; approval of April 15 (from 11:30 a.m. to 5 p.m.) and now available to fund applications faculty appointments and promotions; on April 16 (from 8 a.m. to 12:30 p.m.), submitted in response to the Federal and the awarding of master’s and 2010. Register notice referenced above. doctoral degrees in the biomedical ADDRESSES: The meeting will be held at: Dated: January 7,2010 sciences and public health. The Marshall Hall, Building 62, Room 155, Bernadette McGuire-Rivera, President, USU and the Vice President, the National Defense University, 300 5th Associate Administrator, Office of USU Office of Research will also present Avenue, SW., Fort McNair, Washington, Telecommunications and Information reports. These actions are necessary for DC 20319–5066. the University to pursue its mission, Applications. FOR FURTHER INFORMATION CONTACT: Ms. [FR Doc. 2010–453 Filed 1–12–10; 8:45 am] which is to provide outstanding health Dolores Hodge by phone (202) 685– BILLING CODE 3510–60–S care practitioners and scientists to the 2649, fax (202) 685–7707 or e-mail uniformed services. [email protected]. Meeting Accessibility SUPPLEMENTARY INFORMATION: The future DEPARTMENT OF DEFENSE agenda will include discussion on Pursuant to Federal statute and Defense transformation, faculty Office of the Secretary regulations (5 U.S.C. 552b, as amended, development, facilities, information and 41 CFR 102–3.140 through 102– technology, curriculum development, Board of Regents of the Uniformed 3.165) and the availability of space, this post 9/11 initiatives as well as other Services University of the Health meeting is open to the public. Seating is operational issues and areas of interest Sciences on a first-come basis. affecting the day-to-day operations of AGENCY: Uniformed Services University Written Statements the National Defense University and its of the Health Sciences (USU), DoD. components. The meeting is open to the Interested persons may submit a public; limited space made available for ACTION: Quarterly meeting notice. written statement for consideration by observers will be allocated on a first SUMMARY: Under the provisions of the the Board of Regents. Individuals come, first served basis. Written Federal Advisory Committee Act of submitting a written statement must statements to the committee may be 1972 (5 U.S.C., Appendix, as amended) submit their statement to the Designated submitted at any time or in response to and the Sunshine in the Government Federal Official (see FOR FURTHER a stated planned meeting agenda by fax Act of 1976 (5 U.S.C. 552b, as INFORMATION CONTACT). If such statement or e-mail (see FOR FURTHER INFORMATION amended), this notice announces that is not received at least 10 calendar days CONTACT). The subject line of the e-mail the Board of Regents of the Uniformed prior to the meeting, it may not be should read: ‘‘Comment/Statement to Services University of the Health provided to or considered by the Board the NDU BOV.’’ Sciences (USU) will meet on February 2, of Regents until its next open meeting. Dated: January 7, 2010. 2010. Subject to the availability of The Designated Federal Official will Mitchell S. Bryman, space, the meeting is open to the public. review all timely submissions with the Alternate OSD Federal Register Liaison DATES: The meeting will be held from Board of Regents Chairman and ensure Officer, Department of Defense. 7:30 a.m. to 12:30 p.m. on Tuesday, such submissions are provided to Board [FR Doc. 2010–395 Filed 1–12–10; 8:45 am] February 2, 2010. of Regents Members before the meeting. BILLING CODE 5001–06–P ADDRESSES: The meeting will be held at After reviewing the written comments, the Everett Alvarez Jr. Board of Regents submitters may be invited to orally Room (D3001), Uniformed Services present their issues during the February DEPARTMENT OF EDUCATION University of the Health Sciences, 4301 2010 meeting or at a future meeting. Jones Bridge Road, Bethesda, Maryland Dated: January 7, 2010. Notice of Proposed Information 20814. Mitchell S. Bryman, Collection Requests Alternate OSD Federal Register Liaison AGENCY: Department of Education. 1 Public Telecommunications Facilities Program: Officer, Department of Defense. Closing Date, 74 FR 63120 (Dec. 2, 2009). SUMMARY: The Acting Director, [FR Doc. 2010–393 Filed 1–12–10; 8:45 am] 2 See Pub. L. 111–117, 123 Stat. 3034 (Dec. 16, Information Collection Clearance 2009). BILLING CODE 5001–06–P Division, Regulatory Information

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Management Services, Office of Postdoctoral Survey, Special Education Full Text of Announcement Management, invites comments on the Postdoctoral Survey. I. Funding Opportunity Description proposed information collection Frequency: Annually. requests as required by the Paperwork Affected Public: Individuals or Purpose of Program: The purpose of Reduction Act of 1995. households. this program is to stimulate Reporting and Recordkeeping Hour technological innovation in the private DATES: Interested persons are invited to Burden: sector, strengthen the role of small submit comments on or before March Responses: 695. business in meeting Federal research or 15, 2010. Burden Hours: 174. research and development (R/R&D) SUPPLEMENTARY INFORMATION: Section Abstract: The surveys are for needs, increase the commercial 3506 of the Paperwork Reduction Act of predoctoral and postdoctoral fellows application of the U.S. Department of 1995 (44 U.S.C. Chapter 35) requires taking part in the Institute of Education Education (Department) supported that the Office of Management and Sciences’ three education training grant research results, and improve the return Budget (OMB) provide interested programs under which funds are on investment from federally funded Federal agencies and the public an early provided to universities to support three research for economic and social opportunity to comment on information types of training programs in the benefits to the Nation. collection requests. OMB may amend or education sciences. The results of the Note: This program is in concert with waive the requirement for public survey will be used to both improve the NIDRR’s Final Long-Range Plan for FY 2005– consultation to the extent that public fellowship programs as well as to 2009 (Plan). participation in the approval process provide information on the programs to The Plan, which was published in the would defeat the purpose of the policymakers, practitioners, and the Federal Register on February 15, 2006 information collection, violate State or public. Federal law, or substantially interfere Requests for copies of the proposed (71 FR 8166), can be accessed on the with any agency’s ability to perform its information collection request may be Internet at the following site: http:// statutory obligations. The Acting accessed from http://edicsweb.ed.gov, www.ed.gov/about/offices/lists/osers/ Director, Information Collection by selecting the ‘‘Browse Pending nidrr/policy.html. Through the implementation of the Clearance Division, Regulatory Collections’’ link and by clicking on link Plan, NIDRR seeks to: (1) Improve the Information Management Services, number 4197. When you access the quality and utility of disability and Office of Management, publishes that information collection, click on rehabilitation research; (2) foster an notice containing proposed information ‘‘Download Attachments’’ to view. exchange of expertise, information, and collection requests prior to submission Written requests for information should training to facilitate the advancement of of these requests to OMB. Each be addressed to U.S. Department of knowledge and understanding of the proposed information collection, Education, 400 Maryland Avenue, SW., unique needs of individuals with grouped by office, contains the LBJ, Washington, DC 20202–4537. disabilities from traditionally following: (1) Type of review requested, Requests may also be electronically underserved populations; (3) determine e.g. new, revision, extension, existing or mailed to [email protected] or faxed best strategies and programs to improve reinstatement; (2) Title; (3) Summary of to 202–401–0920. Please specify the rehabilitation outcomes for individuals the collection; (4) Description of the complete title of the information with disabilities from underserved need for, and proposed use of, the collection when making your request. information; (5) Respondents and Comments regarding burden and/or populations; (4) identify research gaps; frequency of collection; and (6) the collection activity requirements (5) identify mechanisms of integrating Reporting and/or Recordkeeping should be electronically mailed to research and practice; and (6) burden. OMB invites public comment. [email protected]. Individuals who disseminate findings. NIDRR Supports Manufacturing- The Department of Education is use a telecommunications device for the Related Innovation (Executive Order especially interested in public comment deaf (TDD) may call the Federal 13329): addressing the following issues: (1) Is Information Relay Service (FIRS) at 1– 800–877–8339. Executive Order 13329 states that this collection necessary to the proper continued technological innovation is functions of the Department; (2) will [FR Doc. 2010–514 Filed 1–12–10; 8:45 am] critical to a strong manufacturing sector this information be processed and used BILLING CODE 4000–01–P in the United States economy and in a timely manner; (3) is the estimate ensures that Federal agencies assist the of burden accurate; (4) how might the private sector in its manufacturing DEPARTMENT OF EDUCATION Department enhance the quality, utility, innovation efforts. The Department’s and clarity of the information to be SBIR program encourages innovative collected; and (5) how might the Office of Special Education and Rehabilitative Services (OSERS); research and development (R&D) Department minimize the burden of this projects that are manufacturing-related, collection on the respondents, including Overview Information; National Institute on Disability and as defined by Executive Order 13329. through the use of information Manufacturing-related R&D technology. Rehabilitation Research (NIDRR)— Small Business Innovation Research encompasses improvements in existing Dated: January 8, 2010. Program (SBIR)—Phase I; Notice methods or processes, or wholly new James Hyler, Inviting Applications for New Awards processes, machines, or systems. The Acting Director, Information Collection for Fiscal Year (FY) 2010 projects supported under the Clearance Division, Regulatory Information Department’s SBIR program encompass Management Services, Office of Management. Catalog of Federal Domestic Assistance a range of manufacturing-related R&D, (CFDA) Number: 84.133S–1. Institute of Education Sciences including projects leading to the Dates: Applications Available: manufacture of such items as artificial Type of Review: New. January 13, 2010. intelligence or information technology Title: IES Research Training Program Deadline for Transmittal of devices, software, and systems. For Surveys: Predoctoral Survey, Applications: March 15, 2010. more information on Executive Order

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13329, please visit the following Web individuals with disabilities; and guidelines. The term ‘‘universal design’’ is site: http://www.sba.gov/sbir/ improving the quality and utility of defined as ‘‘the design of products and execorder.html or contact Lynn Medley disability and rehabilitation research. environments to be usable by all people, to at: [email protected]. Priorities: Under this competition we the greatest extent possible, without the need for adaptation or specialized design’’ (The are particularly interested in Background Center for Universal Design, 1997). Universal applications that address one of the The Small Business Reauthorization design of consumer products minimizes or following five priorities. alleviates barriers that reduce the ability of Act of 2000 (Act) was enacted on Invitational Priorities: For FY 2010 individuals with disabilities to effectively or December 21, 2000. The Act requires these priorities are invitational safely use standard consumer products. (For certain agencies, including the priorities. Under 34 CFR 75.105(c)(1) we more information see http:// Department, to establish SBIR programs do not give an application that meets www.trace.wisc.edu/docs/consumer_product _ by reserving a statutory percentage of one of these invitational priorities a guidelines/consumer.pcs/disabil.htm). their extramural R&D budgets to be competitive or absolute preference over Program Authority: The Small awarded to small business concerns other applications. Business Act, Pub. L. 85–536, as through a uniform, highly competitive Each of the following priorities relate amended (15 U.S.C. 631 and 638), and three-phase process. to innovative research utilizing new title II of the Rehabilitation Act of 1973, The three phases of the SBIR program technologies to address the needs of as amended (29 U.S.C. 760, et seq.). are: individuals with disabilities and their Phase I: Phase I projects determine, Applicable Regulations: The families. Applicants who choose to insofar as possible, the scientific or Education Department General respond to one of the invitational technical merit and feasibility of ideas Administrative Regulations (EDGAR) in priorities must propose projects whose submitted under the SBIR program. An 34 CFR parts 75, 77, 81, 82, 84, 85, 97, activities contribute to one of the application for Phase I should 98, and 99. following priorities: concentrate on research that will (1) Increased independence of II. Award Information contribute significantly to proving the Type of Award: Discretionary grants. scientific or technical feasibility of the individuals with disabilities in the Estimated Available Funds: approach or concept. Scientific or workplace, recreational settings, or $1,125,000 for new Phase I awards. technical feasibility is a prerequisite to educational settings through the the Department’s provision of further development of technology to support Note: The estimated amount of funds support in Phase II. access and promote integration of available for new Phase I awards is based Phase II: Phase II projects expand on individuals with disabilities. upon the estimated threshold SBIR allocation the results of and further pursue the (2) Enhanced sensory or motor for OSERS, minus prior commitments for Phase II continuation awards. development of Phase I projects. Phase function of individuals with disabilities II is the principal R/R&D effort of the through the development of technology Estimated Range of Awards: $70,000– SBIR program. Applications for Phase II to support improved functional $75,000. projects must be more comprehensive capacity. Estimated Average Size of Awards: than applications for Phase I projects; (3) Enhanced workforce participation $75,000. Phase II applications must outline the through the development of technology Maximum Award: We will reject any proposed effort in detail, including the to support access to employment, application that proposes a budget commercial potential of projects or promote sustained employment, and exceeding $75,000 for a single budget processes developed or researched promote employment advancement for period of up to six months. The during the Phase I project. Phase II individuals with disabilities. Assistant Secretary for Special applicants must be Phase I grantees with (4) Enhanced community Education and Rehabilitative Services approaches that appear sufficiently participation and living for individuals may change the maximum amount promising as a result of their efforts in with disabilities through the through a notice published in the Phase I. Phase II awards are for periods development of accessible information Federal Register. technology including Web access of up to two years in amounts up to a Note: The maximum award amount maximum total of $500,000 over a technology, software, and other systems includes direct and indirect costs and fees. and devices that promote access to period of two years. Estimated Number of Awards: 15. Phase III: In Phase III, the small information in educational, business grantee must use non-SBIR employment, and community settings, Note: The Department is not bound by any capital to pursue commercial and voting technology that improves estimates in this notice. applications of the R/R&D. Also, under access for individuals with disabilities. Maximum Project Period: We will Phase III, Federal agencies may award (5) Improved interventions and reject any application that proposes a non-SBIR follow-on funding for increased use of health-care resources project period that exceeds a single products or processes that meet the through the development of technology budget period of up to six months. The needs of those agencies. to support independent access to health- Assistant Secretary for Special All SBIR projects funded by NIDRR care services in the community for Education and Rehabilitative Services must address the needs of individuals individuals with disabilities. may change the maximum project with disabilities and their families. (See Applicants should describe the period through a notice published in the 29 U.S.C. 762). Activities may include: approaches they expect to use to collect Federal Register. conducting manufacturing-related R&D empirical evidence demonstrating the that encompasses improvements in effectiveness of the technology they are III. Eligibility Information existing methods or processes, or proposing. This empirical evidence 1. Eligible Applicants: Entities that wholly new processes, machines, or should facilitate the assessment of the are, at the time of award, small business systems; exploring the uses of efficacy and usefulness of the concerns as defined by the Small technology to ensure equal access to technology. Business Administration (SBA). This education, employment, community Note: NIDRR encourages applicants to definition is included in the application environments, and information for adhere to universal design principles and package.

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If it appears that an applicant with the forms you must submit, are in priorities, or different applications organization does not meet the the application package for this under the same priority. eligibility requirements, we will request competition. Page Limit: The Applicants should consult NIDRR’s an evaluation by the SBA. Under application narrative (Part III of the Long-Range Plan when preparing their circumstances in which eligibility is application) is where you, the applicant, applications. The Plan is organized unclear, we will not make an SBIR address the selection criteria that around the following research domains award until the SBA makes a reviewers use to evaluate your and arenas: (1) Community Living and determination that the applicant is application. You must limit the Participation; (2) Health and Function; eligible under its definition of small application narrative (Part III) to the (3) Technology; (4) Employment; and (5) business concern. equivalent of no more than 25 pages, Demographics. Applicants should All technology, science, or excluding any documentation of prior indicate, for each application, the engineering firms with strong research multiple Phase II awards, if applicable, domain or arena under which they are capabilities in any of the priority areas and required forms, using the following applying. In their applications, listed in this notice are encouraged to standards: applicants should clearly indicate participate. Consultative or other • A ‘‘page’’ is 8.5″ x 11″, on one side whether they are applying for a research arrangements between these firms and only, with 1″ margins at the top, bottom, grant in the area of (1) Community universities or other non-profit and both sides. Living and Participation; (2) Health and organizations are permitted, but the • Single space all text in the Function; (3) Technology; (4) small business concern must serve as application narrative. Single space Employment; or (5) Demographics. the grantee. For Phase I projects, at least titles, headings, footnotes, quotations, 4. Submission Dates and Times: two-thirds of the research and/or references, and captions, as well as all Applications Available: January 13, analytic activities must be performed by text in charts, tables, figures, and 2010. the proposing small business concern graphs. Deadline for Transmittal of grantee. • Use a font that is either 12 point or Applications: March 15, 2010. 2. Cost Sharing or Matching: This larger or no smaller than 10 pitch Applications for grants under this program does not require cost sharing or (characters per inch). competition must be submitted matching. • Use one of the following fonts: electronically using the Electronic Grant 3. Other: The total of all consultant Times New Roman, Courier, Courier Application system (e-Application) fees, facility leases or usage fees, and New, or Arial. An application submitted accessible through the Department’s e- other subcontracts or purchase in any other font (including Times Grants site. For information (including agreements may not exceed one-third of Roman or Arial Narrow) will not be dates and times) about how to submit the total funding award. accepted. your application electronically, or in IV. Application and Submission The page limit does not apply to Part paper format by mail or hand delivery Information I, the coversheet; Part II, the budget if you qualify for an exception to the electronic submission requirement, 1. Address To Request Application section, including the narrative budget please refer to section IV.7. Other Package: You can obtain an application justification; Part IV, the assurances and Submission Requirements of this notice. package via the Internet or from the certifications; or the one-page abstract, ´ ´ We do not consider an application Education Publications Center (ED the resumes, the bibliography, the that does not comply with the deadline Pubs). To obtain a copy via the Internet, letters of support; related application(s) requirements. use the following address: http:// or award(s); or documentation of www.ed.gov/fund/grant/apply/ multiple Phase II awards, if applicable. Individuals with disabilities who grantapps/index.html. However, the page limit does apply to need an accommodation or auxiliary aid To obtain a copy from ED Pubs, write, all of the application project narrative in connection with the application fax, or call the following: Education section (Part III). process should contact the person listed Publications Center, P.O. Box 1398, We will reject your application if you under For Further Information Contact Jessup, MD 20794–1398. Telephone, toll exceed the page limit; or if you apply in section VII of this notice. If the free: 1–877–433–7827. FAX: (301) 470– other standards and exceed the Department provides an accommodation 1244. If you use a telecommunications equivalent of the page limit. or auxiliary aid to an individual with a device for the deaf (TDD), call, toll free: The application package will provide disability in connection with the 1–877–576–7734. instructions for completing all application process, the individual’s You can contact ED Pubs at its Web components to be included in the application remains subject to all other site, also: http://www.ed.gov/pubs/ application. Each application must requirements and limitations in this edpubs.html or at its e-mail address: include a cover sheet (Standard Form notice. [email protected]. 424); budget requirements (ED Form 5. Intergovernmental Review: This If you request an application from ED 524) and narrative budget justification; program is not subject to Executive Pubs, be sure to identify this other required forms; an abstract, Order 12372 and the regulations in 34 competition as follows: CFDA number Human Subjects narrative, Part III CFR part 79. 84.133S–1. project narrative; re´sume´ of staff; and 6. Funding Restrictions: We reference Individuals with disabilities can other related materials, if applicable. regulations outlining funding obtain a copy of the application package 3. Content Restrictions: If an applicant restrictions of the Applicable in an accessible format (e.g., braille, chooses to respond to more than one Regulations section of this notice. large print, audiotape, or computer invitational priority, we request that the 7. Other Submission Requirements: diskette) by contacting the person or applicant submit a separate application Applications for grants under this team listed under Accessible Format in for each priority. There is no limitation competition must be submitted section VIII of this notice. on the number of different applications electronically unless you qualify for an 2. Content and Form of Application that an applicant may submit under this exception to this requirement in Submission: Requirements concerning competition. An applicant may submit accordance with the instructions in this the content of an application, together separate applications for different section.

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a. Electronic Submission of SF 424, Budget Information—Non- unavailability, you may contact either Applications. Construction Programs (ED 524), and all (1) the person listed elsewhere in this Applications for grants under the necessary assurances and certifications. notice under For Further Information SBIR Program—CFDA Number 84.133S– You must attach any narrative sections Contact (see VII. Agency Contact) or (2) 1—must be submitted electronically of your application as files in a .DOC the e-Grants help desk at 1–888–336– using e-Application, accessible through (document), .RTF (rich text), or .PDF 8930. If e-Application is unavailable the Department’s e-Grants Web site at: (Portable Document) format. If you due to technical problems with the http://e-grants.ed.gov. upload a file type other than the three system and, therefore, the application We will reject your application if you file types specified in this paragraph or deadline is extended, an e-mail will be submit it in paper format unless, as submit a password protected file, we sent to all registered users who have described elsewhere in this section, you will not review that material. initiated an e-Application. Extensions qualify for one of the exceptions to the • Your electronic application must referred to in this section apply only to electronic submission requirement and comply with any page limit the unavailability of e-Application. submit, no later than two weeks before requirements described in this notice. Exception to Electronic Submission the application deadline date, a written • Prior to submitting your electronic Requirement: You qualify for an statement to the Department that you application, you may wish to print a exception to the electronic submission qualify for one of these exceptions. copy of it for your records. requirement, and may submit your Further information regarding • After you electronically submit application in paper format, if you are calculation of the date that is two weeks your application, you will receive an unable to submit an application through before the application deadline date is automatic acknowledgment that will e-Application because–– provided later in this section under include a PR/Award number (an • You do not have access to the Exception to Electronic Submission identifying number unique to your Internet; or Requirement. application). • You do not have the capacity to While completing your electronic • Within three working days after upload large documents to e- application, you will be entering data submitting your electronic application, Application; and • online that will be saved into a fax a signed copy of the SF 424 to the No later than two weeks before the database. You may not e-mail an Application Control Center after application deadline date (14 calendar electronic copy of a grant application to following these steps: days or, if the fourteenth calendar day us. (1) Print SF 424 from e-Application. before the application deadline date Please note the following: (2) The applicant’s Authorizing falls on a Federal holiday, the next • You must complete the electronic Representative must sign this form. business day following the Federal submission of your grant application by (3) Place the PR/Award number in the holiday), you mail or fax a written 4:30:00 p.m., Washington, DC time, on upper right hand corner of the hard- statement to the Department, explaining the application deadline date. E- copy signature page of the SF 424. which of the two grounds for an Application will not accept an (4) Fax the signed SF 424 to the exception prevents you from using the application for this competition after Application Control Center at (202) Internet to submit your application. If 4:30:00 p.m., Washington, DC time, on 245–6272. you mail your written statement to the the application deadline date. • We may request that you provide us Department, it must be postmarked no Therefore, we strongly recommend that original signatures on other forms at a later than two weeks before the you do not wait until the application later date. application deadline date. If you fax deadline date to begin the application Application Deadline Date Extension your written statement to the process. in Case of e-Application Unavailability: Department, we must receive the faxed • The hours of operation of the e- If you are prevented from electronically statement no later than two weeks Grants Web site are 6:00 a.m. Monday submitting your application on the before the application deadline date. until 7:00 p.m. Wednesday; and 6:00 application deadline date because e- Address and mail or fax your a.m. Thursday until 8:00 p.m. Sunday, Application is unavailable, we will statement to: Lynn Medley, U.S. Washington, DC time. Please note that, grant you an extension of one business Department of Education, 400 Maryland because of maintenance, the system is day to enable you to transmit your Avenue, SW., room 6027, Potomac unavailable between 8:00 p.m. on application electronically, by mail, or by Center Plaza (PCP), Washington, DC Sundays and 6:00 a.m. on Mondays, and hand delivery. We will grant this 20202–2700. FAX: (202) 245–7338. between 7:00 p.m. on Wednesdays and extension if— Your paper application must be 6:00 a.m. on Thursdays, Washington, (1) You are a registered user of e- submitted in accordance with the mail DC time. Any modifications to these Application and you have initiated an or hand delivery instructions described hours are posted on the e-Grants Web electronic application for this in this notice. site. competition; and b. Submission of Paper Applications • You will not receive additional (2)(a) E-Application is unavailable for by Mail. point value because you submit your 60 minutes or more between the hours If you qualify for an exception to the application in electronic format, nor of 8:30 a.m. and 3:30 p.m., Washington, electronic submission requirement, you will we penalize you if you qualify for DC time, on the application deadline may mail (through the U.S. Postal an exception to the electronic date; or Service or a commercial carrier) your submission requirement, as described (b) E-Application is unavailable for application to the Department. You elsewhere in this section, and submit any period of time between 3:30 p.m. must mail the original and two copies your application in paper format. and 4:30:00 p.m., Washington, DC time, of your application, on or before the • You must submit all documents on the application deadline date. application deadline date, to the electronically, including all information We must acknowledge and confirm Department at the following address: you typically provide on the following these periods of unavailability before U.S. Department of Education, forms: the Application for Federal granting you an extension. To request Application Control Center, Attention: Assistance (SF 424), the Department of this extension or to confirm our (CFDA Number 84.133S–1) LBJ Education Supplemental Information for acknowledgment of any system Basement Level 1, 400 Maryland

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Avenue, SW., Washington, DC 20202– CFR 75.210 of EDGAR and are listed in Education, 400 Maryland Avenue, SW., 4260. the application package. room 6027, PCP, Washington, DC You must show proof of mailing 20202–2700. Telephone: (202) 245–7338 VI. Award Administration Information consisting of one of the following: or by e-mail: [email protected]. (1) A legibly dated U.S. Postal Service 1. Award Notices: If your application If you use a TDD, call the TDD postmark. is successful, we notify your U.S. number at (202) 205–4475. (2) A legible mail receipt with the Representative and U.S. Senators and VIII. Other Information date of mailing stamped by the U.S. send you a Grant Award Notification Postal Service. (GAN). We may notify you informally, Accessible Format: Individuals with (3) A dated shipping label, invoice, or also. disabilities can obtain this document receipt from a commercial carrier. If your application is not evaluated or and a copy of the application package in (4) Any other proof of mailing not selected for funding, we notify you. an accessible format (e.g., braille, large acceptable to the Secretary of the U.S. 2. Administrative and National Policy print, audiotape, or computer diskette) Department of Education. Requirements: We identify by contacting the Grants and Contracts If you mail your application through administrative and national policy Services Team, U.S. Department of the U.S. Postal Service, we do not requirements in the application package Education, 400 Maryland Avenue, SW., accept either of the following as proof and reference these and other room 5075, PCP, Washington, DC of mailing: requirements in the Applicable 20202–2550. Telephone: (202) 245– (1) A private metered postmark. Regulations section of this notice. 7363. If you use a TDD, call the Federal (2) A mail receipt that is not dated by We reference the regulations outlining Relay Service, toll free, at 1–800–877– the U.S. Postal Service. the terms and conditions of an award in 8339. If your application is postmarked after the Applicable Regulations section of Electronic Access to This Document: the application deadline date, we will this notice and include these and other You can view this document, as well as not consider your application. specific conditions in the GAN. The all other documents of this Department GAN also incorporates your approved published in the Federal Register, in Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before application as part of your binding text or Adobe Portable Document relying on this method, you should check commitments under the grant. Format (PDF) on the Internet at the with your local post office. 3. Reporting: At the end of your following site: http://www.ed.gov/news/ project period, you must submit a final fedregister. c. Submission of Paper Applications performance report, including financial To use PDF you must have Adobe by Hand Delivery. information, as directed by the Acrobat Reader, which is available free If you qualify for an exception to the Secretary. If you receive a multi-year at this site. electronic submission requirement, you award, you must submit an annual (or a courier service) may deliver your Note: The official version of this document performance report that provides the is the document published in the Federal paper application to the Department by most current performance and financial Register. Free Internet access to the official hand. You must deliver the original and expenditure information as directed by edition of the Federal Register and the Code two copies of your application, by hand, the Secretary under 34 CFR 75.118. The of Federal Regulations is available on GPO on or before the application deadline Secretary may also require more Access at: http://www.gpoaccess.gov/nara/ date, to the Department at the following frequent performance reports under 34 index.html. address: U.S. Department of Education, CFR 75.720(c). For specific Application Control Center, Attention: Dated: January 8, 2010. requirements on reporting, please go to Alexa Posny, (CFDA Number 84.133S–1) 550 12th http://www.ed.gov/fund/grant/apply/ Street, SW., Room 7041, Potomac Center Assistant Secretary for Special Education and appforms/appforms.html. Rehabilitative Services. Plaza, Washington, DC 20202–4260. 4. Performance Measures: To evaluate The Application Control Center the overall success of its research [FR Doc. 2010–482 Filed 1–12–10; 8:45 am] accepts hand deliveries daily between program, NIDRR assesses the quality of BILLING CODE 4000–01–P 8:00 a.m. and 4:30:00 p.m., Washington, its funded projects through review of DC time, except Saturdays, Sundays, grantee performance and products. Each and Federal holidays. year, NIDRR examines a portion of its DEPARTMENT OF ENERGY Note for Mail or Hand Delivery of Paper SBIR grantees to determine— Federal Energy Regulatory Applications: If you mail or hand deliver • The percentage of National Institute Commission your application to the Department— of Disability and Rehabilitation (1) You must indicate on the envelope Research (NIDRR)-funded grant Combined Notice of Filings #1 and—if not provided by the Department—in applications that receive an average peer Item 11 of the SF 424 the CFDA number, review score of 85 or higher. January 04, 2010. including suffix letter, if any, of the competition under which you are submitting NIDRR uses information submitted by Take notice that the Commission your application; and grantees as part of their Annual received the following electric rate (2) The Application Control Center will Performance Reports (APRs) for these filings: mail to you a notification of receipt of your reviews. Docket Numbers: ER97–4084–011. grant application. If you do not receive this Department of Education program Applicants: Denver City Energy grant notification within 15 business days performance reports, which include Associates, L.P. from the application deadline date, you information on NIDRR programs, are Description: Denver City Energy should call the U.S. Department of Education available on the Department’s Web site: Associates, LP submits compliance Application Control Center at (202) 245– http://www.ed.gov/about/offices/list/ filing under Order 697 and Request for 6288. opepd/sas/index.html. Category 2 Seller Status. Filed Date: 12/22/2009. V. Application Review Information VII. Agency Contact Accession Number: 20091230–0075. Selection Criteria: The selection For Further Information Contact: Comment Date: 5 p.m. Eastern Time criteria for this competition are from 34 Lynn Medley, U.S. Department of on Monday, February 22, 2010.

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Docket Numbers: ER99–2984–014. I, LLC, Arlington Wind Power Project Description: Notification of Change in Applicants: Green Country Energy, LLC. Status of Arlington Valley, LLC, et al. LLC. Description: Notice of change in status Filed Date: 12/30/2009. Description: Market Power Update of filing under part 35 of FERC’s Accession Number: 20091230–5082. Green Country Energy, LLC. regulations of Arlington Wind Power Comment Date: 5 p.m. Eastern Time Filed Date: 12/31/2009. Project LLC, et al. on Wednesday, January 20, 2010. Accession Number: 20091231–5008. Filed Date: 12/30/2009. Docket Numbers: ER10–469–000. Comment Date: 5 p.m. Eastern Time Accession Number: 20091230–5141. Applicants: Northeast Utilities on Monday, March 01, 2010. Comment Date: 5 p.m. Eastern Time Service Company. Docket Numbers: ER00–3614–013. on Wednesday, January 20, 2010. Description: NU Companies submits Applicants: BP Energy Company. Docket Numbers: ER09–1321–003. tariff sheets for the termination of two Description: Market Power Update of Applicants: Blue Canyon Windpower interconnection agreements. BP Energy Company. V LLC. Filed Date: 12/22/2009. Filed Date: 12/31/2009. Description: Notice of change in status Accession Number: 20091224–0005. Accession Number: 20091231–5090. filing under part 35 of FERC’s Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time regulations of Blue Canyon Windpower on Tuesday, January 12, 2010. on Thursday, January 21, 2010. V LLC. Docket Numbers: ER10–470–000. Filed Date: 12/30/2009. Applicants: Southwest Power Pool, Docket Numbers: ER02–1406–014; Accession Number: 20091230–5089. ER01–1099–013; ER99–2928–010. Inc. Comment Date: 5 p.m. Eastern Time Description: Southwest Power Pool, Applicants: Acadia Power Partners, on Wednesday, January 20, 2010. LLC; Cleco Power LLC; Cleco Inc submits a Network Integration Docket Numbers: ER10–78–001. Transmission Service Agreement. Evangeline LLC. Applicants: Orange Grove Energy, L.P. Description: Cleco Power LLC submits Filed Date: 12/22/2009. Description: Orange Grover Energy, Accession Number: 20091224–0004. filing to supplement their updated LP submits a sub. page of its proposed market power analysis. Comment Date: 5 p.m. Eastern Time tariff to correct an incorrect page on Tuesday, January 12, 2010. Filed Date: 12/30/2009. number and an amended version of Docket Numbers: ER10–471–000. Accession Number: 20091231–0102. attachment B etc. Applicants: Duke Energy Carolinas, Comment Date: 5 p.m. Eastern Time Filed Date: 12/28/2009. on Wednesday, January 20, 2010. Accession Number: 20091230–0035. LLC. Description: Duke Energy Carolinas, Docket Numbers: ER03–719–013; Comment Date: 5 p.m. Eastern Time LLC submits Rate Schedule 336, the ER98–830–022; ER03–721–012. on Tuesday, January 19, 2010. Power Purchaser Agreements between Applicants: Millennium Power Docket Numbers: ER10–434–000. Duke Energy Carolinas, LLC and Central Partners, L.P., New Harquahala Applicants: CPI USA North Carolina Electric Power Cooperative, Inc. Generating Company, LLC, New Athens LLC. Description: CPI USA North Carolina Filed Date: 12/22/2009. Generating Company, LLC. Accession Number: 20091224–0008. LLC submits a Notice of Succession Description: Revised notice of non- Comment Date: 5 p.m. Eastern Time informing the Commission that CPI material change in status of New Athens on Tuesday, January 12, 2010. Generating Company, LLC, et al. adopts EPCOR USA NC’s market-based Docket Numbers: ER10–473–000. Filed Date: 12/30/2009. rate tariff as its own etc. Applicants: The United Illuminating Accession Number: 20091230–5090. Filed Date: 12/15/2009. Company. Comment Date: 5 p.m. Eastern Time Accession Number: 20091217–0195. Description: The United Illuminating on Wednesday, January 20, 2010. Comment Date: 5 p.m. Eastern Time on Tuesday, January 19, 2010. Company submits Notice of Docket Numbers: ER05–1491–003. Docket Numbers: ER10–440–000. Termination of the Localized Costs Applicants: Vermont Yankee Nuclear Sharing Agreement. Power Corporation. Applicants: PacifiCorp. Description: PacifiCorp submits the Filed Date: 12/22/2009. Description: Vermont Yankee Nuclear Fiber Communications Addition Accession Number: 20091224–0002. Power Corporation submits compliance Agreement. Comment Date: 5 p.m. Eastern Time filing. Filed Date: 12/16/2009. on Tuesday, January 12, 2010. Filed Date: 12/24/2009. Accession Number: 20091218–0211 Docket Numbers: ER10–474–000. Accession Number: 20091230–0034. Comment Date: 5 p.m. Eastern Time Applicants: San Diego Gas & Electric Comment Date: 5 p.m. Eastern Time on Monday, January 11, 2010. Company. on Thursday, January 14, 2010. Docket Numbers: ER10–450–001; Description: San Diego Gas & Electric Docket Numbers: ER07–357–006. ER01–1044–014; ER00–3696–013; Co submits Ninth Revised Sheet No. 121 Applicants: Fenton Power Partners I, ER01–3109–014; ER02–506–013; ER03– et al. to FERC Electric Tariff, Original LLC. 1383–016; ER07–1000–005; ER09–1491– Volume No. 11. Description: Fenton Power Partners, I, 001; ER96–1947–027; ER98–2783–017; Filed Date: 12/22/2009. LLC submits Substitute Second Revised ER99–2157–014. Accession Number: 20091224–0003. Sheet 4 et al. to FERC Electric Tariff, Applicants: Bluegrass Generation Comment Date: 5 p.m. Eastern Time Original Volume 1. Company, LLC, Las Vegas Power on Tuesday, January 12, 2010. Filed Date: 12/08/2009. Company, LLC, DeSoto County Docket Numbers: ER10–475–000. Accession Number: 20091210–0102. Generating Company, LLC, Griffith Applicants: PJM Interconnection, Comment Date: 5 p.m. Eastern Time Energy LLC, Bridgeport Energy, LLC, LLC. on Monday, January 11, 2009. Rocky Road Power, LLC, Riverside Description: PJM Interconnection, Docket Numbers: ER08–1225–007; Generating Company, LLC, LS Power LLC submits executed interconnection ER08–1111–006; ER08–1226–005. Marketing, LLC, Renaissance Power, service agreement among PJM as the Applicants: Cloud County Wind LLC, Tilton Energy LLC, Arlington Transmission Provider et al. as the Farm, LLC, Pioneer Prairie Wind Farm Valley, LLC. Interconnected Transmission Owner etc.

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Filed Date: 12/22/2009. Description: Niagara Mohawk Power sheets changing the transmission rates Accession Number: 20091224–0082. Corp submits a Notice of Cancellation of under SCE&G’s Open Access Comment Date: 5 p.m. Eastern Time Service Agreement No. 41 et al. Transmission Tariff. on Tuesday, January 12, 2010. Filed Date: 12/23/2009. Filed Date: 12/29/2009. Docket Numbers: ER10–478–000. Accession Number: 20091224–0075. Accession Number: 20091231–0037. Applicants: PJM Interconnection, Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time LLC. on Wednesday, January 13, 2010. on Tuesday, January 19, 2010. Description: PJM Interconnection, Docket Numbers: ER10–511–000. Docket Numbers: ER10–518–000. LLC submits revised tariff sheets of the Applicants: Southwest Power Pool, Applicants: Southwest Power Pool, PJM Open Access Transmission Tariff. Inc. Inc. Filed Date: 12/23/2009. Description: Southwest Power Pool, Description: Southwest Power Pool, Accession Number: 20091224–0080. Inc submits an executed service Inc submits an executed Service Comment Date: 5 p.m. Eastern Time agreement for Network Integration Agreement for Network Integration on Wednesday, January 13, 2010. Transmission Service between Transmission Service between SPP as Docket Numbers: ER10–479–000. Southwest Power Pool, Inc et al. Transmission Provider and Westar Applicants: California Independent Filed Date: 12/29/2009. Energy. System Operator Corporation. Accession Number: 20091230–0074. Filed Date: 12/30/2009. Description: California Independent Comment Date: 5 p.m. Eastern Time Accession Number: 20091231–0045. System Operator Corporation submits a on Tuesday, January 19, 2010. Comment Date: 5 p.m. Eastern Time proposed ISO Tariff amendment that Docket Numbers: ER10–512–000. on Wednesday, January 20, 2010. will enable the ISO to procure Applicants: Southwest Power Pool, Docket Numbers: ER10–523–000. incremental Ancillary Services from Inc. Applicants: New England Power Description: Southwest Power Pool, external Non-Dynamic System etc. Company. Filed Date: 12/22/2009. Inc submits an executed Meter Agent Description: New England Power Accession Number: 20091224–0079. Service agreement with Lincoln Electric Comment Date: 5 p.m. Eastern Time Company submits Amendments to System etc. Integrated Facilities Agreements and on Tuesday, January 12, 2010. Filed Date: 12/29/2009. Service Agreements under FERC Docket Numbers: ER10–480–000. Accession Number: 20091230–0073. Electric Tariff, Original Volume 1. Applicants: PacifiCorp. Comment Date: 5 p.m. Eastern Time Description: PacifiCorp submits an on Tuesday, January 19, 2010. Filed Date: 12/30/2009. Accession Number: 20091231–0231. updated Interconnection Agreement wit Docket Numbers: ER10–513–000. Comment Date: 5 p.m. Eastern Time the State of California Department of Applicants: Southwest Power Pool, on Wednesday, January 20, 2010. Water Resources designated as First Inc. Revised Rate Schedule FERC 241. Description: Southwest Power Pool, Docket Numbers: ER10–524–000; Filed Date: 12/23/2009. Inc submits an executed service ER10–525–000; ER10–526–000; ER10– Accession Number: 20091224–0078. agreement for Firm Point-to-Point 527–000; ER10–528–000. Comment Date: 5 p.m. Eastern Time Transmission Service between Applicants: Idaho Power Company; on Wednesday, January 13, 2010. Southwest Power Pool, Inc et al. Deseret Generation & Transmission Co- Docket Numbers: ER10–482–000; Filed Date: 12/29/2009. op.; NorthWestern Corporation; ER10–483–000; ER10–484–000; ER10– Accession Number: 20091230–0072. PacifiCorp; Portland General Electric 485–000; ER10–486–000; ER10–487– Comment Date: 5 p.m. Eastern Time Company. 000; ER10–488–000; ER10–489–000; on Tuesday, January 19, 2010. Description: Idaho Power Co et al ER10–490–000; ER10–491–000; ER10– Docket Numbers: ER10–514–000. submits Second Revised Rate Schedule 492–000; ER10–493–000; ER10–494– Applicants: Midwest Independent FERC No. 152 et al. 000. Transmission System Operator, Inc. Filed Date: 12/29/2009. Applicants: Duke Energy Commercial Description: Midwest Independent Accession Number: 20091231–0230. Enterprises, Inc.; CinCap IV, LLC; Transmission System Operator, Inc Comment Date: 5 p.m. Eastern Time CinCap V LLC; Cinergy Capital & submits their Adjacent Balancing on Tuesday, January 19, 2010. Trading, Inc.; Cinergy Power Authority Coordination Agreement with Docket Numbers: ER10–529–000. Investments, Inc.; St. Paul the Big Rivers Electric Corporation etc. Applicants: PJM Interconnection, Congeneration, LLC; Duke Energy Filed Date: 12/29/2009. LLC. Trading & Marketing, LLC; CinCap IV, Accession Number: 20091230–0071. Description: PJM Interconnection, LLC; Cincap V, LLC; Cinergy Capital & Comment Date: 5 p.m. Eastern Time LLC submits amendments to Schedule Trading, Inc.; Cinergy Power on Tuesday, January 19, 2010. 12–Appendix. Investments, Inc.; St. Paul Cogeneration, Docket Numbers: ER10–515–000. Filed Date: 12/30/2009. LLC; Duke Energy Trading and Applicants: Xcel Energy Services Inc. Accession Number: 20091231–0240. Marketing, LLC. Description: Southwestern Public Comment Date: 5 p.m. Eastern Time Description: Duke Energy Commercial Service Company submits an executed on Wednesday, January 20, 2010. Enterprises, Inc submits FERC Electric copy of the Second Amended and Docket Numbers: ER10–530–000. notice of succession and clean copy of Restated Transaction Agreement. Applicants: PJM Interconnection, DECE’s FERC Electric Rate Schedule 1 Filed Date: 12/28/2009. LLC. effective 11/25/09. Accession Number: 20091231–0038. Description: PJM Interconnection, Filed Date: 12/22/2009. Comment Date: 5 p.m. Eastern Time LLC submits an executed Accession Number: 20091224–0077. on Tuesday, January 19, 2010. interconnection service agreement. Comment Date: 5 p.m. Eastern Time Docket Numbers: ER10–516–000. Filed Date: 12/31/2009. on Tuesday, January 12, 2010. Applicants: South Carolina Electric & Accession Number: 20091231–0241. Docket Numbers: ER10–497–000. Gas Company. Comment Date: 5 p.m. Eastern Time Applicants: Niagara Mohawk Power Description: South Carolina Electric & on Thursday, January 21, 2010. Corporation. Gas Company submits revised tariff Docket Numbers: ER10–531–000.

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Applicants: Southwest Power Pool, Filed Date: 11/20/2009. DEPARTMENT OF ENERGY Inc. Accession Number: 20091120–5134. Federal Energy Regulatory Description: Southwest Power Pool, Comment Date: 5 p.m. Eastern Time Commission Inc submits a Network Integration on Monday, January 25, 2009. Transmission Service Agreement. Filed Date: 12/30/2009. Any person desiring to intervene or to Combined Notice of Filings protest in any of the above proceedings Accession Number: 20091231–0242. January 4, 2010. Comment Date: 5 p.m. Eastern Time must file in accordance with Rules 211 and 214 of the Commission’s Rules of Take notice that the Commission has on Wednesday, January 20, 2010. received the following Natural Gas Docket Numbers: ER10–532–000. Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern Pipeline Rate and Refund Report filings: Applicants: PJM Interconnection, Docket Numbers: RP10–269–000. time on the specified comment date. It LLC. Applicants: Rockies Express Pipeline is not necessary to separately intervene Description: PJM Interconnection, LLC. LLC submits an executed again in a subdocket related to a Description: Rockies Express Pipeline interconnection service agreement. compliance filing if you have previously LLC submits Original Sheet No. 11C to Filed Date: 12/30/2009. intervened in the same docket. Protests FERC Gas Tariff, Second Revised Accession Number: 20091231–0244. will be considered by the Commission Volume No. 1. Comment Date: 5 p.m. Eastern Time in determining the appropriate action to Filed Date: 12/28/2009. on Wednesday, January 20, 2010. be taken, but will not serve to make Accession Number: 20091229–0057. Take notice that the Commission protestants parties to the proceeding. Comment Date: 5 p.m. Eastern Time received the following electric securities Anyone filing a motion to intervene or on Monday, January 11, 2010. protest must serve a copy of that filings: Docket Numbers: RP10–270–000. document on the Applicant. In reference Applicants: Discovery Gas Docket Numbers: ES10–21–000. to filings initiating a new proceeding, Applicants: AEP Texas North Transmission LLC, interventions or protests submitted on Description: Discovery Gas Company. or before the comment deadline need Description: Application by AEP Transmission LLC submits for filing its not be served on persons other than the Fourth Revised Sheet 23, to become Texas North Company Under Section Applicant. 204 of the Federal Power Act for effective 5/1/09. Authorization to Issue Securities. The Commission encourages Filed Date: 12/29/2009. Filed Date: 12/29/2009. electronic submission of protests and Accession Number: 20091230–0050. Accession Number: 20091229–5041. interventions in lieu of paper, using the Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time FERC Online links at http:// on Monday, January 11, 2010. on Tuesday, January 19, 2010. www.ferc.gov. To facilitate electronic Docket Numbers: RP10–271–000. service, persons with Internet access Take notice that the Commission Applicants: Southern LNG Inc. who will eFile a document and/or be Description: Southern LNG, Inc received the following public utility listed as a contact for an intervenor holding company filings: submits for filing Third Revised Sheet 1 must create and validate an et al. to FERC Gas Tariff, Original Docket Numbers: PH10–6–000. eRegistration account using the Volume 1 to become effective 3/1/10. Applicants: General Electric eRegistration link. Select the eFiling Filed Date: 12/29/2009. Company. link to log on and submit the Accession Number: 20091230–0051. Description: Exemption Notification intervention or protests. Comment Date: 5 p.m. Eastern Time (Form FERC–65A) of General Electric Persons unable to file electronically on Monday, January 11, 2010. Company. should submit an original and 14 copies Docket Numbers: RP10–272–000. Filed Date: 12/29/2009. of the intervention or protest to the Applicants: Millennium Pipeline Accession Number: 20091229–5038. Federal Energy Regulatory Commission, Company, LLC. Comment Date: 5 p.m. Eastern Time 888 First St. NE., Washington, DC Description: Millennium Pipeline on Tuesday, January 19, 2010. 20426. Company, LLC submits Third Revised Docket Numbers: PH10–7–000. The filings in the above proceedings Sheet 51 et al. to FERC Gas Tariff, Applicants: BlackRock, Inc. are accessible in the Commission’s Original Volume 1. Description: FERC 65A—Exemption eLibrary system by clicking on the Filed Date: 12/30/2009. Notification of Status as Passive appropriate link in the above list. They Accession Number: 20091230–0049. Investors of BlackRock, Inc. are also available for review in the Comment Date: 5 p.m. Eastern Time Filed Date: 12/31/2009. on Monday, January 11, 2010. Accession Number: 20091231–5093. Commission’s Public Reference Room in Washington, DC. There is an Docket Numbers: RP10–273–000. Comment Date: 5 p.m. Eastern Time Applicants: EnergyMark, LLC. on Thursday, January 21, 2010. eSubscription link on the Web site that enables subscribers to receive e-mail Description: Constellation Take notice that the Commission notification when a document is added NewEnergy—Gas Division, LLC et al. received the following electric to a subscribed dockets(s). For submits request for a temporary waiver reliability filings: assistance with any FERC Online of FERC’s capacity release policies and Docket Numbers: RD10–9–000. service, please e-mail regulations in order facilitate the Applicants: North American Electric [email protected]. or call acquisition. Reliability Corp. (866) 208–3676 (toll free). For TTY, call Filed Date: 12/29/2009. Description: Errata Petition of the (202) 502–8659. Accession Number: 20091230–0048. North American Electric Reliability Comment Date: 5 p.m.Eastern Time Corporation for Approval of Corrected Kimberly D. Bose, on Monday, January 11, 2010. Reliability Standard FAC–010–2— Secretary. Docket Numbers: RP10–274–000. System Operating Limits Methodology [FR Doc. 2010–481 Filed 1–12–10; 8:45 am] Applicants: Wyoming Interstate for the Planning Horizon. BILLING CODE 6717–01–P Company.

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Description: Wyoming Interstate Comment Date: 5 p.m. Eastern Time Filed Date: 12/30/2009. Company, Ltd submits for filing and on Monday, January 11, 2010. Accession Number: 20091231–0032. acceptance a Fourteenth Revised Sheet Docket Numbers: RP10–280–000. 1 to its FERC Gas Tariff, Second Revised Comment Date: 5 p.m. Eastern Time Applicants: Rockies Express Pipeline on Monday, January 11, 2010. Volume 2. LLC. Filed Date: 12/29/2009. Description: Rockies Express Pipeline, Any person desiring to intervene or to Accession Number: 20091230–0047. LLC submits Original Sheet 11D to protest in any of the above proceedings Comment Date: 5 p.m. Eastern Time FERC Gas Tariff, Second Revised must file in accordance with Rules 211 on Monday, January 11, 2010. Volume 1, to be effective 1/1/10. and 214 of the Commission’s Rules of Docket Numbers: RP10–275–000. Filed Date: 12/30/2009. Practice and Procedure (18 CFR 385.211 Applicants: Wyoming Interstate Accession Number: 20091231–0027. and 385.214) on or before 5 p.m. Eastern Company, Ltd. Comment Date: 5 p.m. Eastern Time time on the specified comment date. It Description: Wyoming Interstate on Monday, January 11, 2010. is not necessary to separately intervene Company, Ltd submits for filing and Docket Numbers: RP10–281–000. again in a subdocket related to a acceptance a firm transportation service Applicants: Gulf South Pipeline compliance filing if you have previously agreement with Devon Energy Company, LP. intervened in the same docket. Protests Production Company, LP. Description: Gulf South Pipeline will be considered by the Commission Filed Date: 12/29/2009. Company, LP submits amendment to a in determining the appropriate action to Accession Number: 20091230–0046. negotiated rate letter agreement re the be taken, but will not serve to make Comment Date: 5 p.m. Eastern Time East Texas to Mississippi Expansion protestants parties to the proceeding. on Monday, January 11, 2010. Project. Anyone filing a motion to intervene or Docket Numbers: RP10–276–000. Filed Date: 12/30/2009. protest must serve a copy of that Applicants: Iroquois Gas Accession Number: 20091231–0028. document on the Applicant. In reference Transmission System, L.P. Comment Date: 5 p.m. Eastern Time to filings initiating a new proceeding, Description: Iroquois Gas on Monday, January 11, 2010. interventions or protests submitted on Transmission System, L.P. Measurement or before the comment deadline need Variance/Fuel Use Factors utilized by Docket Numbers: RP10–282–000. Applicants: Kinder Morgan Interstate not be served on persons other than the Iroquois during July 1, 2009–December Applicant. 31, 2009. Gas Trans. LLC. The Commission encourages Filed Date: 12/30/2009. Description: Kinder Morgan Interstate electronic submission of protests and Accession Number: 20091230–5088. Gas Transmission, LLC submits Twenty Comment Date: 5 p.m. Eastern Time Sixth Revised Sheet 4G.01 et al. to FERC interventions in lieu of paper, using the on Monday, January 11, 2010. Gas Tariff, Fourth Revised Volume 1A, FERC Online links at http:// to be effective 1/1/10. www.ferc.gov. To facilitate electronic Docket Numbers: RP10–277–000. Filed Date: 12/30/2009. service, persons with Internet access Applicants: National Fuel Gas Supply Accession Number: 20091231–0029. who will eFile a document and/or be Corporation. Comment Date: 5 p.m. Eastern Time listed as a contact for an intervenor Description: National Fuel Gas Supply on Monday, January 11, 2010. must create and validate an Corporation submits Non-conforming Docket Numbers: RP10–283–000. eRegistration account using the Service Agreements to FERC Gas Tariff, eRegistration link. Select the eFiling Fourth Revised Volume 2 with Crown Applicants: Northern Natural Gas Company. link to log on and submit the Energy Services, Inc et al., effective intervention or protests. 1/29/10. Description: Northern Natural Gas Filed Date: 12/30/2009. Company submits 14 Revised Sheet Persons unable to file electronically Accession Number: 20091231–0024. 66B.35 to FERC Gas Tariff, Fifth Revised should submit an original and 14 copies Comment Date: 5 p.m. Eastern Time Volume 1, to be effective 1/1/10. of the intervention or protest to the on Monday, January 11, 2010. Filed Date: 12/30/2009. Federal Energy Regulatory Commission, Docket Numbers: RP10–278–000. Accession Number: 20091231–0030. 888 First St., NE., Washington, DC Applicants: Texas Eastern Comment Date: 5 p.m. Eastern Time 20426. Transmission, LP on Monday, January 11, 2010. The filings in the above proceedings Description: Texas Eastern Docket Numbers: RP10–284–000. are accessible in the Commission’s Transmission, LP submits Thirty-Third Applicants: Millennium Pipeline eLibrary system by clicking on the Revised Sheet 25 et al., to FERC Gas Company, LLC. appropriate link in the above list. They Tariff, Seventh Revised Volume 1 and Description: Millennium Pipeline are also available for review in the First Revised Volume 2, to be effective Company, LLC submits the Penalty Commission’s Public Reference Room in 2/1/10. Revenue Crediting Report to FERC Gas Washington, DC. There is an Filed Date: 12/30/2009. Tariff, Original Volume 1. eSubscription link on the Web site that Accession Number: 20091231–0025. Filed Date: 12/30/2009. enables subscribers to receive e-mail Comment Date: 5 p.m. Eastern Time Accession Number: 20091231–0031. notification when a document is added on Monday, January 11, 2010. Comment Date: 5 p.m. Eastern Time to a subscribed docket(s). For assistance Docket Numbers: RP10–279–000. on Monday, January 11, 2010. with any FERC Online service, please e- Applicants: Florida Gas Transmission Docket Numbers: RP10–285–000. mail [email protected]. or Company, LLC. Applicants: Sea Robin Pipeline call (866) 208–3676 (toll free). For TTY, Description: Florida Gas Transmission Company, LLC. call (202) 502–8659. Company, LLC submits the Annual Description: Sea Robin Pipeline Nathaniel J. Davis, Sr., Accounting Report which details the Company, LLC submits the Annual activity of FGT’s Cash-Out Mechanism. Flowthrough Crediting Mechanism to Deputy Secretary. Filed Date: 12/30/2009. FERC Gas Tariff, Second Revised [FR Doc. 2010–463 Filed 1–12–10; 8:45 am] Accession Number: 20091231–0026. Volume 1. BILLING CODE 6717–01–P

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DEPARTMENT OF ENERGY Accession Number: 20091230–0065. Filed Date: 12/28/2009. Comment Date: 5 p.m. Eastern Time Accession Number: 20091230–0040. Federal Energy Regulatory on Tuesday, January 12, 2010. Comment Date: 5 p.m. Eastern Time Commission Docket Numbers: ER10–78–001. on Tuesday, January 19, 2010. Applicants: Orange Grove Energy, L.P. Docket Numbers: ER10–509–000. Combined Notice of Filings #1 Description: Orange Grover Energy, Applicants: PJM Interconnection, December 30, 2009. LP submits a substitute page of its L.L.C. Description: PJM Interconnection, Take notice that the Commission proposed tariff to correct an incorrect LLC submits revised Interconnection received the following electric corporate page number and an amended version of Service Agreement with Richmond filings: attachment B to the application etc. Docket Numbers: EC10–32–000. Filed Date: 12/28/2009. Energy, LLC et al. that supersedes the Applicants: NSTAR Companies, Accession Number: 20091230–0035. Original Service Agreement 2205. Filed Date: 12/28/2009. Advanced Energy Systems, Inc., Comment Date: 5 p.m. Eastern Time on Tuesday, January 19, 2010. Accession Number: 20091230–0038. Medical Area Total Energy Plant, Inc., Comment Date: 5 p.m. Eastern Time MATEP LLC, New MATEP, Inc. Docket Numbers: ER10–472–000. on Tuesday, January 19, 2010. Description: Application under Applicants: Katahdin Paper Company Section 203 of the Federal Power Act for Docket Numbers: ER10–510–000. LLC. Applicants: Southern California authorization of the sale of stock and Description: Katahdin Paper Co, LLC Edison Company. disposition of facilities of Advanced submits the Notice of Cancellation of Description: Southern California Energy Systems, Inc., MATEP LLC, Market-Based Rate Tariff and request for Edison Company submits the MATEP Inc., New MATEP Inc., and waiver of the prior notice requirement. unexecuted Brea Power II Standard NSTAR. Filed Date: 12/22/2009. Large Generator Interconnection Filed Date: 12/29/2009. Accession Number: 20091224–0001. Agreement, Service Agreement for Accession Number: 20091229–5103. Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time Wholesale Distribution Service etc. on Tuesday, January 12, 2010. Filed Date: 12/28/2009. on Tuesday, January 19, 2010. Docket Numbers: ER10–477–000. Accession Number: 20091230–0036. Take notice that the Commission Applicants: Consolidated Edison Comment Date: 5 p.m. Eastern Time received the following electric rate Company of New York, Inc. on Tuesday, January 19, 2010. filings: Description: Consolidated Edison Take notice that the Commission Docket Numbers: ER03–198–012. Company of New York, Inc submits a received the following electric Applicants: Pacific Gas and Electric revised Master Services Agreement and reliability filings: Company. Transaction Forms between Con Edison Docket Numbers: RD09–7–002. Description: Pacific Gas and Electric and Bayonne Energy Center, LLC. Applicants: North American Electric Company submits its triennial market Filed Date: 12/23/2009. Reliability Corp. power update for the Southwest Region. Description: Compliance Filing of the Filed Date: 12/23/2009. Accession Number: 20091224–0085. Comment Date: 5 p.m. Eastern Time North American Electric Reliability Accession Number: 20091229–0058. Corp. in Response to FERC’s September Comment Date: 5 p.m. Eastern Time on Wednesday, January 13, 2010. Docket Numbers: ER10–501–000. 30, 2009 Order Approving Revised on Wednesday, January 13, 2010. Reliability Standards for Critical Docket Numbers: ER06–615–058; Applicants: Southern California Edison Company. Infrastructure Protection and Requiring ER07–1257–012. Compliance Filing. Applicants: California Independent Description: Southern California Edison Company submits revised rate Filed Date: 12/29/2009. System Operator Corporation. Accession Number: 20091229–5104. sheets reflection cancellation of the Description: California Independent Comment Date: 5 p.m. Eastern Time letter agreements. System Operator Corporation submits on Tuesday, January 19, 2010. First Revised Sheet 116B et al. to FERC Filed Date: 12/23/2009. Any person desiring to intervene or to Electric Tariff, Fourth Replacement Accession Number: 20091228–0022. protest in any of the above proceedings Volume 1 in compliance with the Comment Date: 5 p.m. Eastern Time must file in accordance with Rules 211 Commission’s 12/3/09 Order. on Wednesday, January 13, 2010. and 214 of the Commission’s Rules of Filed Date: 12/28/2009. Docket Numbers: ER10–505–000. Practice and Procedure (18 CFR 385.211 Accession Number: 20091230–0037. Applicants: Dynegy Services Plum and 385.214) on or before 5 p.m. Eastern Comment Date: 5 p.m. Eastern Time Point, LLC. time on the specified comment date. It on Tuesday, January 19, 2010. Description: Dynegy Services Plum is not necessary to separately intervene Docket Numbers: ER09–712–002; Point, LLC submits an application for again in a subdocket related to a ER06–736–002; ER02–2263–010; ER01– market-based rate authorization under compliance filing if you have previously 2217–008; ER08–931–004; ER08–337– Section 205 of the Federal Power Act intervened in the same docket. Protests 005. etc. will be considered by the Commission Applicants: High Lonesome Mesa, Filed Date: 12/28/2009. in determining the appropriate action to LLC, Midway-Sunset Cogeneration Accession Number: 20091229–0056. be taken, but will not serve to make Company, Southern California Edison Comment Date: 5 p.m. Eastern Time protestants parties to the proceeding. Company, Sunrise Power Company, on Tuesday, January 19, 2010. Anyone filing a motion to intervene or Walnut Creek Energy, LLC, Watson Docket Numbers: ER10–508–000. protest must serve a copy of that Cogeneration Company. Applicants: Nevada Power Company. document on the Applicant. In reference Description: Southwest EIX MBR Description: NV Energy submits an to filings initiating a new proceeding, Affiliates submits market power executed Interconnection Agreement interventions or protests submitted on analysis and revised MBR Tariffs re the designated as Service Agreement 09– or before the comment deadline need High Lonesome Mesa, LLC et al. 01804 between NPC and El Dorado not be served on persons other than the Filed Date: 12/22/2009. Energy, LLC. Applicant.

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The Commission encourages Original Sheet 236 to First Revised DEPARTMENT OF ENERGY electronic submission of protests and Sheet 236. Federal Energy Regulatory interventions in lieu of paper, using the Filed Date: 12/16/2009. FERC Online links at http:// Commission www.ferc.gov. To facilitate electronic Accession Number: 20091216–0125. service, persons with Internet access Comment Date: 5 p.m. Eastern Time Combined Notice of Filings who will eFile a document and/or be on Monday, December 28, 2009. December 28, 2009. listed as a contact for an intervenor Docket Numbers: RP10–178–001. Take notice that the Commission has must create and validate an received the following Natural Gas Applicants: Steuben Gas Storage eRegistration account using the Pipeline Rate and Refund Report filings: eRegistration link. Select the eFiling Company. Docket Numbers: RP10–254–000. link to log on and submit the Description: Steuben Gas Storage Co’s Applicants: East Tennessee Natural intervention or protests. filing of a revision to Order No. 712 and Gas, LLC. Persons unable to file electronically Order No. 587–T Compliance Filing Description: East Tennessee Natural should submit an original and 14 copies under RP10–178. Gas, LLC submits Eighth Revised Sheet of the intervention or protest to the Filed Date: 12/17/2009. 394 to its FERC Gas Tariff, Third Federal Energy Regulatory Commission, Revised Volume 1 to be effective 1/13/ 888 First St., NE., Washington, DC Accession Number: 20091218–0202. 10. 20426. Comment Date: 5 p.m. Eastern Time Filed Date: 12/18/2009. The filings in the above proceedings on Tuesday, December 29, 2009. Accession Number: 20091222–0048. are accessible in the Commission’s Comment Date: 5 p.m. Eastern Time eLibrary system by clicking on the Any person desiring to protest this on Wednesday, December 30, 2009. filing must file in accordance with Rule appropriate link in the above list. They Docket Numbers: RP10–255–000. 211 of the Commission’s Rules of are also available for review in the Applicants: Maritimes & Northeast Commission’s Public Reference Room in Practice and Procedure (18 CFR Pipeline, LLC. Washington, DC. There is an 385.211). Protests to this filing will be Description: Maritimes & Northeast eSubscription link on the Web site that considered by the Commission in Pipeline submits Original Sheet 9S et al. enables subscribers to receive e-mail determining the appropriate action to be to its FERC Gas Tariff, First Revised notification when a document is added taken, but will not serve to make Volume 1. to a subscribed docket(s). For assistance protestants parties to the proceeding. Filed Date: 12/18/2009. with any FERC Online service, please e- Such protests must be filed in on or Accession Number: 20091222–0047. mail [email protected]. or before 5 p.m. Eastern time on the Comment Date: 5 p.m. Eastern Time call (866) 208–3676 (toll free). For TTY, specified comment date. Anyone filing on Wednesday, December 30, 2009. call (202) 502–8659. a protest must serve a copy of that Docket Numbers: RP10–256–000. Nathaniel J. Davis, Sr., document on all the parties to the Applicants: Northwest Pipeline GP. Deputy Secretary. proceeding. Description: Northwest Pipeline, GP submits Fifth Revised Sheet 395 et al. to [FR Doc. 2010–457 Filed 1–12–10; 8:45 am] The Commission encourages its FERC Gas Tariff, Fourth Revised BILLING CODE P electronic submission of protests in lieu Volume 1. of paper using the ‘‘eFiling’’ link at Filed Date: 12/18/2009. http://www.ferc.gov. Persons unable to DEPARTMENT OF ENERGY Accession Number: 20091222–0046. file electronically should submit an Comment Date: 5 p.m. Eastern Time original and 14 copies of the protest to Federal Energy Regulatory on Wednesday, December 30, 2009. Commission the Federal Energy Regulatory Docket Numbers: RP10–257–000. Commission, 888 First Street, NE., Applicants: Rockies Express Pipeline Combined Notice of Filings Washington, DC 20426. LLC. This filing is accessible on-line at Description: Rockies Express Pipeline, December 23, 2009. LLC submits Original Sheet 11B to its Take notice that the Commission has http://www.ferc.gov, using the ‘‘ ’’ FERC Gas Tariff, Second Revised received the following Natural Gas eLibrary link and is available for review in the Commission’s Public Volume 1. Pipeline Rate and Refund Report filings: Filed Date: 12/18/2009. Docket Numbers: RP09–1037–002. Reference Room in Washington, DC. Accession Number: 20091222–0045. Applicants: Questar Pipeline There is an ‘‘eSubscription’’ link on the Comment Date: 5 p.m. Eastern Time Company. Web site that enables subscribers to Description: Questar Pipeline receive e-mail notification when a on Wednesday, December 30, 2009. Company submits Second Substitute document is added to a subscribed Docket Numbers: RP10–258–000. Eighth Revised Sheet 8 to its FERC Gas docket(s). For assistance with any FERC Applicants: Northern Natural Gas Tariff, First Revised Volume 1, to be Online service, please e-mail Company. Description: Northern Natural Gas effective 10/7/09. [email protected], or call Company submits 12 Revised Sheet Filed Date: 10/22/2009. (866) 208–3676 (toll free). For TTY, call 66B.35 to its FERC Gas Tariff, Fifth Accession Number: 20091023–0012. (202) 502–8659. Comment Date: 5 p.m. Eastern Time Revised Volume 1. on Tuesday, December 29, 2009. Nathaniel J. Davis, Sr., Filed Date: 12/18/2009. Docket Numbers: RP10–234–001. Deputy Secretary. Accession Number: 20091222–0044. Comment Date: 5 p.m. Eastern Time Applicants: Eastern Shore Natural Gas [FR Doc. 2010–460 Filed 1–12–10; 8:45 am] Company. on Wednesday, December 30, 2009. Description: Eastern Shore Natural BILLING CODE 6717–01–P Docket Numbers: RP10–259–000. Gas Company submits the corrected Applicants: Transcontinental Gas pagination for Sheet 236, filed as Pipe Line Company,

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Description: Transcontinental Gas Applicants: Sabine Pipe Line LLC. of the intervention or protest to the Pipe Line Company, LLC submits First Description: Sabine Pipe Line LLC Federal Energy Regulatory Commission, Revised Sheet 502 et al. to its FERC Gas submits Original Sheet No. 310B et al. 888 First St. NE., Washington, DC Tariff, Fourth Revised Volume 1, to be to FERC Gas Tariff, Original Volume No. 20426. effective 1/18/10. 1. The filings in the above proceedings Filed Date: 12/18/2009. Filed Date: 12/22/2009. are accessible in the Commission’s Accession Number: 20091222–0043. Accession Number: 20091224–0020. eLibrary system by clicking on the Comment Date: 5 p.m. Eastern Time Comment Date: 5 p.m. Eastern Time appropriate link in the above list. They on Wednesday, December 30, 2009. on Monday, January 04, 2010. are also available for review in the Docket Numbers: RP10–260–000. Docket Numbers: RP10–267–000. Commission’s Public Reference Room in Applicants: Transcontinental Gas Applicants: Bear Creek Storage Washington, DC. There is an Pipe Line Company, LLC. Company, LLC. eSubscription link on the Web site that Description: Transcontinental Gas Description: Notice of name change enables subscribers to receive e-mail Pipe Line Company, LLC submits First for Bear Creek Storage Company to Bear notification when a document is added Revised Sheet 336 et al. to its FERC Gas Creek Storage Company, LLC of Bear to a subscribed docket(s). For assistance Tariff, Fourth Revised Volume 1 to be Creek Storage Company. with any FERC Online service, please e- effective 1/18/10. Filed Date: 12/21/2009. mail [email protected]. or Filed Date: 12/18/2009. Accession Number: 20091221–5134. call (866) 208–3676 (toll free). For TTY, Accession Number: 20091222–0042. Comment Date: 5 p.m. Eastern Time call (202) 502–8659. Comment Date: 5 p.m. Eastern Time on Monday, January 04, 2010. on Wednesday, December 30, 2009. Nathaniel J. Davis, Sr., Docket Numbers: RP10–268–000. Deputy Secretary. Docket Numbers: RP10–261–000. Applicants: Kinder Morgan Interstate [FR Doc. 2010–461 Filed 1–12–10; 8:45 am] Applicants: Northern Natural Gas Gas Trans. LLC. Company. Description: Kinder Morgan Interstate BILLING CODE 6717–01–P Description: Northern Natural Gas Gas Transmission LLC Submits 2009 Company submits 13 Revised Sheet Reconciliation Filing. DEPARTMENT OF ENERGY 66B.35 to FERC Gas Tariff, Fifth Revised Filed Date: 12/22/2009. Volume 1 to be effective 12/22/09. Accession Number: 20091222–5236. Federal Energy Regulatory Filed Date: 12/22/2009. Comment Date: 5 p.m. Eastern Time Commission Accession Number: 20091222–0041. on Monday, January 04, 2010. Comment Date: 5 p.m. Eastern Time Any person desiring to intervene or to Combined Notice of Filings on Monday, January 04, 2010. protest in any of the above proceedings Docket Numbers: RP10–262–000. must file in accordance with Rules 211 December 22, 2009. Applicants: Gulf South Pipeline and 214 of the Commission’s Rules of Take notice that the Commission has Company, LP. Practice and Procedure (18 CFR 385.211 received the following Natural Gas Description: Gulf South Pipeline Co, and 385.214) on or before 5 p.m. Eastern Pipeline Rate and Refund Report filings: LP submits First Revised Sheet No. 2500 time on the specified comment date. It Docket Numbers: RP10–241–000. to FERC Gas Tariff, Sixth Revised is not necessary to separately intervene Applicants: Questar Overthrust Volume No. 1. again in a subdocket related to a Pipeline Company. Filed Date: 12/22/2009. compliance filing if you have previously Description: Questar Overthurst Accession Number: 20091223–0091. intervened in the same docket. Protests Pipeline Company submits Third Comment Date: 5 p.m. Eastern Time will be considered by the Commission Revised Sheet 1 et al. to its FERC Gas on Monday, January 04, 2010. in determining the appropriate action to Tariff, Second Revised Volume 1–A, to Docket Numbers: RP10–264–000. be taken, but will not serve to make be effective 2/1/10. Applicants: Natural Gas Pipeline protestants parties to the proceeding. Filed Date: 12/16/2009. Company of America LLC. Anyone filing a motion to intervene or Accession Number: 20091216–0126. Description: Natural Gas Pipeline protest must serve a copy of that Comment Date: 5 p.m. Eastern Time Company of America LLC submits an document on the Applicant. In reference on Monday, December 28, 2009. amendment to an existing Firm to filings initiating a new proceeding, Docket Numbers: RP10–242–000. Transportation Rate Discount interventions or protests submitted on Applicants: MarkWest Pioneer, L.L.C. Agreement with The Board of Trustees or before the comment deadline need Description: MarkWest Pioneer, LLC of University of Illinois, to be effective not be served on persons other than the submits Second Revised Sheet No 76 et 1/1/10. Applicant. al. FERC Gas Tariff, Original Volume No Filed Date: 12/23/2009. The Commission encourages 1. Accession Number: 20091224–0019. electronic submission of protests and Filed Date: 12/16/2009. Comment Date: 5 p.m. Eastern Time interventions in lieu of paper, using the Accession Number: 20091217–0190. on Monday, January 04, 2010. FERC Online links at http:// Comment Date: 5 p.m. Eastern Time Docket Numbers: RP10–265–000. www.ferc.gov. To facilitate electronic on Monday, December 28, 2009. Applicants: Equitrans, LP. service, persons with Internet access Docket Numbers: RP10–243–000. Description: Equitrans, LP submits who will eFile a document and/or be Applicants: Rockies Express Pipeline Fifteenth Revised Sheet 11 to FERC Gas listed as a contact for an intervenor LLC. Tariff, Original Volume 1, to be effective must create and validate an Description: Rockies Express Pipeline 1/1/10. eRegistration account using the LLC submits Fourteenth Revised Sheet Filed Date: 12/23/2009. eRegistration link. Select the eFiling 10 et al. of its FERC Gas Tariff, Second Accession Number: 20091224–0018. link to log on and submit the Revised Volume 1, to be effective 12/17/ Comment Date: 5 p.m. Eastern Time intervention or protests. 09. on Monday, January 04, 2010. Persons unable to file electronically Filed Date: 12/16/2009. Docket Numbers: RP10–266–000. should submit an original and 14 copies Accession Number: 20091217–0191.

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Comment Date: 5 p.m. Eastern Time Docket Numbers: RP10–250–000. FERC Online links at http:// on Monday, December 28, 2009. Applicants: Crossroads Pipeline www.ferc.gov. To facilitate electronic Docket Numbers: RP10–244–000. Company. service, persons with Internet access Applicants: Maritimes & Northeast Description: Crossroads Pipeline who will eFile a document and/or be Pipeline, L.L.C. Company’s submits Penalty Revenue listed as a contact for an intervenor Description: Maritimes & Northeast Crediting Report. must create and validate an Pipeline, LLC submits Sixth Revised Filed Date: 12/18/2009. eRegistration account using the Sheet No. 1 et al. to FERC Gas Tariff, Accession Number: 20091218–0477. eRegistration link. Select the eFiling First Revised Volume No. 1. Comment Date: 5 p.m. Eastern Time link to log on and submit the Filed Date: 12/17/2009. on Wednesday, December 30, 2009. intervention or protests. Accession Number: 20091218–0201. Docket Numbers: RP10–251–000. Persons unable to file electronically Comment Date: 5 p.m. Eastern Time Applicants: Columbia Gulf should submit an original and 14 copies on Tuesday, December 29, 2009. Transmission Company. of the intervention or protest to the Federal Energy Regulatory Commission, Docket Numbers: RP10–245–000. Description: Columbia Gulf 888 First St., NE., Washington, DC Applicants: Rockies Express Pipeline Transmission Company submits Penalty 20426. LLC. Revenue Crediting Report. The filings in the above proceedings Description: Rockies Express Pipeline Filed Date: 12/18/2009. are accessible in the Commission’s LLC submits Original Sheet No. 11A et Accession Number: 20091218–0476. eLibrary system by clicking on the al. to its FERC Gas Tariff, Second Comment Date: 5 p.m. Eastern Time appropriate link in the above list. They Revised Volume No. 1. on Wednesday, December 30, 2009. are also available for review in the Filed Date: 12/17/2009. Docket Numbers: RP10–252–000. Commission’s Public Reference Room in Accession Number: 20091218–0203. Applicants: Columbia Gas Washington, DC. There is an Comment Date: 5 p.m. Eastern Time Transmission, LLC. eSubscription link on the Web site that on Tuesday, December 29, 2009. Description: Columbia Gas Transmission, LLC submits Penalty enables subscribers to receive e-mail Docket Numbers: RP10–246–000. Revenue Crediting Report. notification when a document is added Applicants: Texas Gas Transmission, Filed Date: 12/18/2009. to a subscribed docket(s). For assistance LLC. Accession Number: 20091218–0475. with any FERC Online service, please e- Description: Texas Gas Transmission, Comment Date: 5 p.m. Eastern Time mail [email protected]. or LLC submits Fifth Revised Sheet No. on Wednesday, December 30, 2009. call (866) 208–3676 (toll free). For TTY, 35A to FERC Gas Tariff, Third Revised call (202) 502–8659. Volume No. 1. Docket Numbers: RP10–253–000. Filed Date: 12/17/2009. Applicants: Great Lakes Gas Nathaniel J. Davis, Sr., Accession Number: 20091218–0463. Transmission Limited Partnership. Deputy Secretary. Comment Date: 5 p.m. Eastern Time Description: Great Lakes Gas [FR Doc. 2010–462 Filed 1–12–10; 8:45 am] Transmission Limited Partnership on Tuesday, December 29, 2009. BILLING CODE 6717–01–P submits Seventh Revised Sheet 4A et al. Docket Numbers: RP10–247–000. to FERC Gas tariff, Second Revised Applicants: Equitrans, L.P. Volume 1, to be effective 2/1/10. DEPARTMENT OF ENERGY Description: Equitrans, LP submits Filed Date: 12/18/2009. Third Revised Sheet 441 to be effective Accession Number: 20091218–0473. Federal Energy Regulatory 1/17/10. Comment Date: 5 p.m. Eastern Time Commission Filed Date: 12/18/2009. on Wednesday, December 30, 2009. Accession Number: 20091218–0480. Any person desiring to intervene or to Notice of Filings Comment Date: 5 p.m. Eastern Time protest in any of the above proceedings December 30, 2009. on Wednesday, December 30, 2009. must file in accordance with Rules 211 Take notice that the Commission has Docket Numbers: RP10–248–000. and 214 of the Commission’s Rules of received the following Natural Gas Applicants: Central Kentucky Practice and Procedure (18 CFR 385.211 Pipeline Rate and Refund Report filings: Transmission Company. and 385.214) on or before 5 p.m. Eastern Description: Central Kentucky Docket Numbers: RP09–558–002. time on the specified comment date. It Applicants: Transcontinental Gas Transmission Company’s submits is not necessary to separately intervene Penalty Revenue Crediting Report. Pipe Line Company. again in a subdocket related to a Description: Transcontinental Gas Filed Date: 12/18/2009. compliance filing if you have previously Pipe Line Company, LLC requests that Accession Number: 20091218–0479. intervened in the same docket. Protests the Commission reject as moot Original Comment Date: 5 p.m. Eastern Time will be considered by the Commission Sheet 89 and Original Sheet 90 to FERC on Wednesday, December 30, 2009. in determining the appropriate action to Gas Tariff, Fourth Revised Volume 1, to Docket Numbers: RP10–249–000. be taken, but will not serve to make be effective 12/15/09. Applicants: Columbia Gas protestants parties to the proceeding. Filed Date: 12/22/2009. Transmission, LLC. Anyone filing a motion to intervene or Accession Number: 20091228–0028. Description: Columbia Gas protest must serve a copy of that Comment Date: 5 p.m. Eastern Time Transmission, LLC submits petition for document on the Applicant. In reference on Monday, January 4, 2010. a limited waiver of Section 40.5 of the to filings initiating a new proceeding, Docket Numbers: RP09–687–003. General Terms and Conditions of interventions or protests submitted on Applicants: Equitrans, L.P. Columbia’s FERC Gas Tariff, Third or before the comment deadline need Description: Filing Motion of Revised Volume 1. not be served on persons other than the Equitrans, L.P. for Extension of Time to Filed Date: 12/18/2009. Applicant. Comply with Order No. 587–T issued on Accession Number: 20091218–0478. The Commission encourages December 22, 2009. Comment Date: 5 p.m. Eastern Time electronic submission of protests and Filed Date: 12/22/2009. on Wednesday, December 30, 2009. interventions in lieu of paper, using the Accession Number: 20091222–5204.

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Comment Date: 5 p.m. Eastern Time document is added to a subscribed The final report includes the on Monday, January 4, 2010. docket(s). For assistance with any FERC development of exploratory methods for Docket Numbers: RP10–147–002. Online service, please e-mail analyzing genomic data for application Applicants: Natural Gas Pipeline [email protected], or call to risk assessment and some preliminary Company of America. (866) 208–3676 (toll free). For TTY, call results. In addition, recommendations Description: Emergency Motion of (202) 502–8659. for risk assessors, research needs, and future directions for generating and Natural Gas Pipeline Company of Nathaniel J. Davis, Sr., America LLC for Limited Stay of applying genomic data in risk Deputy Secretary. Requirement to File Cost and Revenue assessment are described. The approach Study. [FR Doc. 2010–459 Filed 1–12–10; 8:45 am] and case study may be used as a Filed Date: 12/22/2009. BILLING CODE 6717–01–P template for evaluating and analyzing Accession Number: 20091222–5279. genomic data in future chemical Comment Date: 5 p.m. Eastern Time assessments and the methods and on Monday, January 4, 2010. ENVIRONMENTAL PROTECTION research needs may be used by Docket Numbers: RP09–614–001. AGENCY researchers performing genomic studies Applicants: Cheniere Creole Trail for use in risk assessment. Pipeline, LP. [FRL–9094–9] ADDRESSES: The document will be available electronically through the Description: Request of Cheniere An Approach to Using Toxicogenomic NCEA Web site at www.epa.gov/ncea. A Creole Trail Pipeline LP for Limited Data in U.S. EPA Human Health Risk limited number of paper copies will be Waiver of Order No. 712 Electronic Assessments: A Dibutyl Phthalate available from the EPA’s National Capacity Release Requirements. Case Study Filed Date: 12/23/2009. Service Center for Environmental Accession Number: 20091223–4009. AGENCY: Environmental Protection Publications (NSCEP), P.O. Box 42419, Comment Date: 5 p.m. Eastern Time Agency (EPA). Cincinnati, OH 45242; telephone: 1– on Monday, January 4, 2010. ACTION: Notice of availability. 800–490–9198; facsimile: 301–604– Docket Numbers: RP10–19–001. 3408; e-mail: [email protected]. Applicants: Columbia Gas SUMMARY: EPA is announcing the Please provide your name, your mailing Transmission, LLC. availability of a final report titled, ‘‘An address, the title and the EPA number Description: Columbia Gas Approach to Using Toxicogenomic Data of the requested publication. Transmission, LLC submits Tenth in U.S. EPA Human Health Risk FOR FURTHER INFORMATION CONTACT: The Revised Sheet 28 et al to its FERC Gas Assessments: A Dibutyl Phthalate Case Information Management Team, Tariff, Third Volume 1, to be effective Study’’ (EPA/600/R–09/028F), which National Center for Environmental 11/1/09. was prepared by the National Center for Assessment (8601P), U.S. Filed Date: 12/23/2009. Environmental Assessment (NCEA) Environmental Protection Agency, 1200 Accession Number: 20091224–0074. within EPA’s Office of Research and Pennsylvania Avenue, NW., Comment Date: 5 p.m. Eastern Time Development (ORD). Washington, DC 20460. Telephone: on Monday, January 4, 2010. Toxicogenomics is the application of 703–347–8561; fax: 703–347–8691; e- Any person desiring to protest this genomic technologies (e.g., mail: [email protected]. filing must file in accordance with Rule transcriptomics, genome sequence Dated: October 27, 2009. analysis) to study effects of 211 of the Commission’s Rules of Peter W. Preuss, Practice and Procedure (18 CFR environmental chemicals on human health and the environment. Currently, Director, National Center for Environmental 385.211). Protests to this filing will be Assessment. considered by the Commission in EPA provides no guidance for determining the appropriate action to be evaluating and incorporating genomic [FR Doc. 2010–486 Filed 1–12–10; 8:45 am] taken, but will not serve to make data into risk assessment. This report BILLING CODE 6560–50–P protestants parties to the proceeding. describes an approach to evaluate Such protests must be filed on or before toxicogenomic data for use in risk ENVIRONMENTAL PROTECTION 5 p.m. Eastern time on the specified assessment and a case study for dibutyl AGENCY comment date. Anyone filing a protest phthalate (DBP). A multidisciplinary must serve a copy of that document on team of scientists developed the [FRL–9102–5] all the parties to the proceeding. approach and performed the case study. The Commission encourages In this approach, the genomic data and Proposed Consent Decree, Clean Air electronic submission of protests in lieu the human outcome and/or toxicity data Act Citizen Suit of paper using the ‘‘eFiling’’ link at are considered together to determine the AGENCY: Environmental Protection http://www.ferc.gov. Persons unable to relationship between genomic changes Agency (EPA). file electronically should submit an and toxicity or health outcomes and ACTION: Notice of proposed consent original and 14 copies of the protest to inform mechanisms and modes of decree; request for public comment. the Federal Energy Regulatory toxicity. The DBP case study focuses on Commission, 888 First Street, NE., male reproductive developmental SUMMARY: In accordance with section Washington, DC 20426. effects and the use of genomic data in 113(g) of the Clean Air Act, as amended This filing is accessible on-line at qualitative aspects of the risk (‘‘Act’’), 42 U.S.C. 7413(g), notice is http://www.ferc.gov, using the assessment because of the type of hereby given of a proposed consent ‘‘eLibrary’’ link and is available for genomic data available for DBP. It is decree, to address a lawsuit filed by review in the Commission’s Public important to note that the case study WildEarth Guardians in the United Reference Room in Washington, DC. presented in this report is a separate States District Court for the District of There is an ‘‘eSubscription’’ link on the activity from any of the ongoing IRIS Colorado: WildEarth Guardians v. Web site that enables subscribers to human health assessments for the Jackson, No. 09–cv–01964–MSK–MEH receive e-mail notification when a phthalates. (D. Colo.). Plaintiff filed a deadline suit

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to compel the Administrator to respond decree states that within fifteen (15) www.regulations.gov without change, to an administrative petition seeking business days following signature of its unless the comment contains EPA’s objection to a CAA Title V response EPA shall deliver notice of copyrighted material, CBI, or other operating permit issued by the Colorado such action to the Office of the Federal information whose disclosure is Department of Public Health and Register for prompt publication. The restricted by statute. Information Environment, Air Pollution Division, to proposed consent decree sets the claimed as CBI and other information the Public Service of Colorado to attorneys’ fees at $3,520.00, and states whose disclosure is restricted by statute operate the Hayden Station power plant that, after EPA fulfills its obligations is not included in the official public near Hayden, Colorado. Under the terms under the decree, the case shall be docket or in the electronic public of the proposed consent decree, EPA has dismissed with prejudice. docket. EPA’s policy is that copyrighted agreed to respond to the petition by For a period of thirty (30) days material, including copyrighted material March 25, 2010, or within 20 days of the following the date of publication of this contained in a public comment, will not entry date of this Consent Decree, notice, the Agency will accept written be placed in EPA’s electronic public whichever is later. comments relating to the proposed docket but will be available only in DATES: Written comments on the consent decree from persons who were printed, paper form in the official public proposed consent decree must be not named as parties or intervenors to docket. Although not all docket received by February 12, 2010. the litigation in question. EPA or the materials may be available ADDRESSES: Submit your comments, Department of Justice may withdraw or electronically, you may still access any identified by Docket ID number EPA– withhold consent to the proposed of the publicly available docket HQ–OGC–2010–0007, online at http:// consent decree if the comments disclose materials through the EPA Docket www.regulations.gov (EPA’s preferred facts or considerations that indicate that Center. method); by e-mail to such consent is inappropriate, B. How and To Whom Do I Submit [email protected]; mailed to EPA improper, inadequate, or inconsistent Comments? with the requirements of the Act. Unless Docket Center, Environmental You may submit comments as Protection Agency, Mailcode: 2822T, EPA or the Department of Justice determines that consent to this consent provided in the ADDRESSES section. 1200 Pennsylvania Ave., NW., Please ensure that your comments are Washington, DC 20460–0001; or by decree should be withdrawn, the terms of the decree will be affirmed. submitted within the specified comment hand delivery or courier to EPA Docket period. Comments received after the Center, EPA West, Room 3334, 1301 II. Additional Information About close of the comment period will be Constitution Ave., NW., Washington, Commenting on the Proposed Consent marked ‘‘late.’’ EPA is not required to DC, between 8:30 a.m. and 4:30 p.m. Decree consider these late comments. Monday through Friday, excluding legal If you submit an electronic comment, A. How Can I Get a Copy of the Consent holidays. Comments on a disk or CD– EPA recommends that you include your Decree? ROM should be formatted in Word or name, mailing address, and an e-mail ASCII file, avoiding the use of special The official public docket for this address or other contact information in characters and any form of encryption, action (identified by Docket ID No. the body of your comment and with any and may be mailed to the mailing EPA–HQ–OGC–2010–0007) contains a disk or CD–ROM you submit. This address above. copy of the proposed consent decree. ensures that you can be identified as the FOR FURTHER INFORMATION CONTACT: The official public docket is available submitter of the comment and allows Amy Branning, Air and Radiation Law for public viewing at the Office of EPA to contact you in case EPA cannot Office (2344A), Office of General Environmental Information (OEI) Docket read your comment due to technical Counsel, U.S. Environmental Protection in the EPA Docket Center, EPA West, difficulties or needs further information Agency, 1200 Pennsylvania Ave., NW., Room 3334, 1301 Constitution Ave., on the substance of your comment. Any Washington, DC 20460; telephone: (202) NW., Washington, DC. The EPA Docket identifying or contact information 564–1744; fax number (202) 564–5603; Center Public Reading Room is open provided in the body of a comment will e-mail address: [email protected]. from 8:30 a.m. to 4:30 p.m., Monday be included as part of the comment that SUPPLEMENTARY INFORMATION: through Friday, excluding legal is placed in the official public docket, holidays. The telephone number for the and made available in EPA’s electronic I. Additional Information About the Public Reading Room is (202) 566–1744, public docket. If EPA cannot read your Proposed Consent Decree and the telephone number for the OEI comment due to technical difficulties This proposed consent decree would Docket is (202) 566–1752. and cannot contact you for clarification, resolve a lawsuit alleging that the An electronic version of the public EPA may not be able to consider your Administrator failed to perform a docket is available through http:// comment. nondiscretionary duty to grant or deny, www.regulations.gov. You may use the Use of the http://www.regulations.gov within 60 days of submission, an http://www.regulations.gov to submit or Web site to submit comments to EPA administrative petition to object to a view public comments, access the index electronically is EPA’s preferred method CAA Title V permit issued by the listing of the contents of the official for receiving comments. The electronic Colorado Department of Public Health public docket, and to access those public docket system is an ‘‘anonymous and Environment, Air Pollution documents in the public docket that are access’’ system, which means EPA will Division, to the Public Service of available electronically. Once in the not know your identity, e-mail address, Colorado to operate the Hayden Station system, key in the appropriate docket or other contact information unless you power plant near Hayden, Colorado. identification number then select provide it in the body of your comment. Under the terms of the proposed ‘‘search’’. In contrast to EPA’s electronic public consent decree, EPA has agreed to It is important to note that EPA’s docket, EPA’s electronic mail (e-mail) respond to the petition by March 25, policy is that public comments, whether system is not an ‘‘anonymous access’’ 2010, or within 20 days of the entry date submitted electronically or in paper, system. If you send an e-mail comment of this Consent Decree, whichever is will be made available for public directly to the Docket without going later. In addition, the proposed consent viewing online at http:// through http://www.regulations.gov,

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your e-mail address is automatically Protection Agency, Rm. S–4400, One Facility are from 8:30 a.m. to 4 p.m., captured and included as part of the Potomac Yard (South Bldg.), 2777 S. Monday through Friday, excluding legal comment that is placed in the official Crystal Dr., Arlington,VA. Deliveries are holidays. The Docket Facility telephone public docket, and made available in only accepted during the Docket number is (703) 305–5805. EPA’s electronic public docket. Facility’s normal hours of operation FOR FURTHER INFORMATION CONTACT: Dated: January 7, 2010. (8:30 a.m. to 4 p.m., Monday through Mike Mendelsohn, Biopesticides and Friday, excluding legal holidays). Richard B. Ossias, Pollution Prevention Division (7511P), Special arrangements should be made Office of Pesticide Programs, Associate General Counsel. for deliveries of boxed information. The Environmental Protection Agency, 1200 [FR Doc. 2010–483 Filed 1–12–10; 8:45 am] Docket Facility telephone number is Pennsylvania Ave., NW., Washington, BILLING CODE 6560–50–P (703) 305–5805. DC 20460–0001; telephone number: Instructions: Direct your comments to (703) 308–8715; e-mail address: docket ID number EPA–HQ–OPP–2009– [email protected]. ENVIRONMENTAL PROTECTION 0615. EPA’s policy is that all comments SUPPLEMENTARY INFORMATION: AGENCY received will be included in the docket [EPA–HQ–OPP–2009–0615; FRL–8433–2] without change and may be made I. General Information available on-line at http:// Pesticide Experimental Use Permits; www.regulations.gov, including any A. Does this Action Apply to Me? Receipt of Applications; Comment personal information provided, unless This action is directed to the public Requests the comment includes information in general. This action may, however, be claimed to be Confidential Business of interest to those persons interested in AGENCY: Environmental Protection Information (CBI) or other information agricultural biotechnology or those who Agency (EPA). whose disclosure is restricted by statute. are or may be required to conduct ACTION: Notice. Do not submit information that you testing of chemical substances under the consider to be CBI or otherwise Federal Food, Drug, and Cosmetic Act SUMMARY: This notice announces EPA’s (FFDCA) or the Federal Insecticide, receipt of applications 29964–EUP–I protected through regulations.gov or e- Fungicide, and Rodenticide Act and 29964–EUP–O from Pioneer Hi- mail. The regulations.gov website is an ‘‘ ’’ (FIFRA). Since other entities may also Bred International, Inc. requesting anonymous access system, which means EPA will not know your identity be interested, the Agency has not experimental use permits (EUPs) for or contact information unless you attempted to describe all the specific seed blends of the plant-incorporated provide it in the body of your comment. entities that may be affected by this protectants (PIPs) [DAS–59122–7] If you send an e-mail comment directly action. If you have any questions Bacillus thuringiensis Cry34Ab1 and to EPA without going through regarding the applicability of this action Cry35Ab1 proteins and the genetic regulations.gov, your e-mail address to a particular entity, consult the person material (vector PHP 17662) necessary will be automatically captured and listed under FOR FURTHER INFORMATION for their production in Event DAS– included as part of the comment that is CONTACT. 59122–7 corn and [TC1507] Bacillus placed in the docket and made available thuringiensis Cry1F protein and the on the Internet. If you submit an B. What Should I Consider as I Prepare genetic material (vector PHP8999) electronic comment, EPA recommends My Comments for EPA? necessary for its production in Event that you include your name and other 1. Submitting CBI. Do not submit this TC1507 corn and [MON810] Bacillus contact information in the body of your information to EPA through thuringiensis Cry1Ab delta-endotoxin comment and with any disk or CD-ROM regulations.gov or e-mail. Clearly mark and the genetic material necessary for you submit. If EPA cannot read your the part or all of the information that its production (Vector PV–ZMCT01) in comment due to technical difficulties you claim to be CBI. For CBI Event MON810 corn (Organization for and cannot contact you for clarification, information in a disk or CD-ROM that Economic Cooperation and EPA may not be able to consider your you mail to EPA, mark the outside of the Development (OECD) Unique Identifier comment. Electronic files should avoid disk or CD-ROM as CBI and then ;; ; MON 81 –6). The Agency has the use of special characters, any form identify electronically within the disk or determined that the permits may be of of encryption, and be free of any defects CD-ROM the specific information that is regional and national significance. or viruses. claimed as CBI. In addition to one Therefore, in accordance with 40 CFR Docket: All documents in the docket complete version of the comment that 172.11(a), the Agency is soliciting are listed in the docket index available includes information claimed as CBI, a comments on these applications. at http://www.regulations.gov. Although copy of the comment that does not DATES: Comments must be received on listed in the index, some information is contain the information claimed as CBI or before February 12, 2010. not publicly available, e.g., CBI or other must be submitted for inclusion in the ADDRESSES: Submit your comments, information whose disclosure is public docket. Information so marked identified by docket identification (ID) restricted by statute. Certain other will not be disclosed except in number EPA–HQ–OPP–2009–0615, by material, such as copyrighted material, accordance with procedures set forth in one of the following methods: is not placed on the Internet and will be 40 CFR part 2. • Federal eRulemaking Portal: http:// publicly available only in hard copy 2. Tips for preparing your comments. www.regulations.gov. Follow the on-line form. Publicly available docket When submitting comments, remember instructions for submitting comments. materials are available either in the to: • Mail: Office of Pesticide Programs electronic docket at http:// i. Identify the document by docket ID (OPP) Regulatory Public Docket (7502P), www.regulations.gov, or, if only number and other identifying Environmental Protection Agency, 1200 available in hard copy, at the OPP information (subject heading, Federal Pennsylvania Ave., NW., Washington, Regulatory Public Docket in Rm. S– Register date and page number). DC 20460–0001. 4400, One Potomac Yard (South Bldg.), ii. Follow directions. The Agency may • Delivery: OPP Regulatory Public 2777 S. Crystal Dr., Arlington, VA. The ask you to respond to specific questions Docket (7502P), Environmental hours of operation of this Docket or organize comments by referencing a

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Code of Federal Regulations (CFR) part in Event TC1507 corn (a maximum of Four trial protocols will be or section number. 2.6 lbs Cry1F). conducted, including: iii. Explain why you agree or disagree; Summary of Request: The 29964– • Trait advancement trial (TAT). suggest alternatives and substitute EUP–I application is for a total of 36,670 • Agronomic observations. language for your requested changes. acres in 11 states from March 1, 2010 to • IRM/efficacy. iv. Describe any assumptions and May 31, 2011 in order to continue • University. provide any technical information and/ research, testing, and evaluation of States involved include: Alabama, or data that you used. blended refuge concepts. 35,200 acres Arkansas, California, Colorado, v. If you estimate potential costs or are proposed for testing under a grower Delaware, Georgia, Idaho, Illinois, burdens, explain how you arrived at evaluation protocol and will include Indiana, Iowa, Kansas, Kentucky, your estimate in sufficient detail to seed blends of: 1) 5% Cry1F corn with Lousianna, Maryland, Michigan, allow for it to be reproduced. 95% Cry34Ab1/35Ab1 x Cy1F corn, 2) Minnesota, Mississippi, Missouri, vi. Provide specific examples to 10% Cry1F corn with 95% Cry34Ab1/ Montana, Nebraska, New York, North illustrate your concerns and suggest 35Ab1 x Cy1F corn, 3) 95% Cry34Ab1/ Carolina, North Dakota, Ohio, alternatives. 35Ab1 x Cy1F corn with 5% non-Bt Pennsylvania, South Carolina, South vii. Explain your views as clearly as corn, and 4) 90% Cry34Ab1/35Ab1 x Dakota, Tennessee, Texas, Virginia, possible, avoiding the use of profanity Cy1F corn with 10% non-Bt corn. 1,470 Washington, and Wisconsin. or personal threats. acres are proposed for testing under a A copy of the applications and any viii. Make sure to submit your research trial protocol and will include information submitted is available for comments by the comment period the seed blends mentioned in this public review in the docket established deadline identified. paragraph along with Cry34Ab1/35Ab1 for these EUP applications as described 3. Environmental justice. EPA seeks to x Cy1F corn and Cry34Ab1/35Ab1 corn under ADDRESSES. achieve environmental justice, the fair as comparators and non-PIP corn as a Following the review of the treatment and meaningful involvement control. States involved include: applications and any comments and of any group, including minority and/or Illinois, Indiana, Iowa, Kansas, data received in response to this low income populations, in the Michigan, Minnesota, Missouri, solicitation, EPA will decide whether to development, implementation, and Nebraska, Ohio, South Dakota, and issue or deny the EUP requests, and if enforcement of environmental laws, Wisconsin. issued, the conditions under which it is regulations, and policies. To help Submitter: Pioneer Hi-Bred to be conducted. Any issuance of EUPs address potential environmental justice International, Inc. (29964–EUP–O). will be announced in the Federal issues, the Agency seeks information on Pesticide Chemical: [DAS–59122–7] Register. any groups or segments of the Bacillus thuringiensis Cry34Ab1 and List of Subjects population who, as a result of their Cry35Ab1 proteins and the genetic location, cultural practices, or other material (vector PHP 17662) necessary Environmental protection, factors, may have atypical or for their production in Event DAS– Experimental use permits. disproportionately high and adverse 59122–7 corn (a maximum of 0.630 lbs Dated: December 29, 2009. human health impacts or environmental Cry34Ab1 and 0.040 lbs Cry35Ab1), effects from exposure to the pesticide(s) [TC1507] Bacillus thuringiensis Cry1F W. Michael McDavit, discussed in this document, compared protein and the genetic material (vector Acting Director, Biopesticides and Pollution to the general population. PHP8999) necessary for its production Prevention Division, Office of Pesticide in Event TC1507 corn (a maximum of Programs. II. What Action is the Agency Taking? 0.110 lbs Cry1F), and [MON810] [FR Doc. 2010–334 Filed 1–12–10; 8:45 am] Under section 5 of FIFRA, 7 U.S.C. Bacillus thuringiensis Cry1Ab delta- BILLING CODE 6560–50–S 136c, EPA can allow manufacturers to endotoxin and the genetic material field test pesticides under development. necessary for its production (Vector PV– Manufacturers are required to obtain ZMCT01) in Event MON810 corn (OECD ENVIRONMENTAL PROTECTION EUPs before testing new pesticides or Unique Identifier MON;;81;–6) (a AGENCY maximum of 0.011 lbs Cry1Ab). new uses of pesticides if they conduct [EPA–HQ–OPP–2009–0917; FRL–8805–6] experimental field tests on 10 acres or Summary of Request: The 29964– more of land or one acre or more of EUP–O application is for 3,495.4 acres Notice of Receipt of a Pesticide water. in 34 states from February 1, 2010 to Petition Filed for Residues of Pursuant to 40 CFR 172.11(a), the June 30, 2011 in order to continue Polymeric Polyhydroxy Acid in or on Agency has determined that the research, testing, and evaluation of All Food Commodities following EUP applications may be of blended refuge concepts. The following regional and national significance, and are proposed for testing: 1) 300.4 acres AGENCY: Environmental Protection therefore is seeking public comment on of a 95% blend of Cry1F x Cry1Ab corn Agency (EPA). the EUP applications: and 5% non-Bt corn, 2) 295 acres of a ACTION: Notice. Submitter: Pioneer Hi-Bred blend of 90% Cry34Ab1/35Ab1 x Cy1F International, Inc., (29964–EUP–I). and 10% non-Bt corn, 3) 333.4 acres of SUMMARY: This notice announces the Pesticide Chemical: [DAS–59122–7] a 95% blend of Cry1F x Cry1Ab x Agency’s receipt of an initial filing of a Bacillus thuringiensis Cry34Ab1 and Cry34Ab1/35Ab1 corn and 5% non-Bt pesticide petition proposing the Cry35Ab1 proteins and the genetic corn, 4) 328 acres of a 90% blend of establishment of a regulation for material (vector PHP 17662) necessary Cry1F x Cry1Ab x Cry34Ab1/35Ab1 residues of the plant growth regulator, for their production in Event DAS– corn and 10% non-Bt corn, 5) 734.4 polymeric polyhydroxy acid, in or on all 59122–7 corn (a maximum of 40.8 lbs acres of other registered PIPs, 6) 300.4 food commodities. Cry34Ab1 and 2.2 lbs Cry35Ab1) and acres of Cry1F x Cry1Ab corn, 7) 333.4 DATES: Comments must be received on [TC1507] Bacillus thuringiensis Cry1F acres of Cry1F x Cry1Ab x Cry34Ab1/ or before February 12, 2010. protein and the genetic material (vector 35Ab1 corn, and 8) 870.4 acres of non- ADDRESSES: Submit your comments, PHP8999) necessary for its production PIP corn. identified by docket identification (ID)

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number EPA–HQ–OPP–2009–0917 and information whose disclosure is you mail to EPA, mark the outside of the the pesticide petition number (PP), by restricted by statute. Certain other disk or CD-ROM as CBI and then one of the following methods: material, such as copyrighted material, identify electronically within the disk or • Federal eRulemaking Portal: http:// is not placed on the Internet and will be CD-ROM the specific information that is www.regulations.gov. Follow the on-line publicly available only in hard copy claimed as CBI. In addition to one instructions for submitting comments. form. Publicly available docket complete version of the comment that • Mail: Office of Pesticide Programs materials are available either in the includes information claimed as CBI, a (OPP) Regulatory Public Docket (7502P), electronic docket at http:// copy of the comment that does not Environmental Protection Agency, 1200 www.regulations.gov, or, if only contain the information claimed as CBI Pennsylvania Ave., NW., Washington, available in hard copy, at the OPP must be submitted for inclusion in the DC 20460–0001. Regulatory Public Docket in Rm. S– public docket. Information so marked • Delivery: OPP Regulatory Public 4400, One Potomac Yard (South Bldg.), will not be disclosed except in Docket (7502P), Environmental 2777 S. Crystal Dr., Arlington, VA. The accordance with procedures set forth in Protection Agency, Rm. S–4400, One hours of operation of this Docket 40 CFR part 2. Potomac Yard (South Bldg.), 2777 S. Facility are from 8:30 a.m. to 4 p.m., 2. Tips for preparing your comments. Crystal Dr., Arlington, VA. Deliveries Monday through Friday, excluding legal When submitting comments, remember are only accepted during the Docket holidays. The Docket Facility telephone to: Facility’s normal hours of operation number is (703) 305–5805. i. Identify the document by docket ID (8:30 a.m. to 4 p.m., Monday through FOR FURTHER INFORMATION CONTACT: number and other identifying Friday, excluding legal holidays). Menyon Adams, Biopesticides and information (subject heading, Federal Special arrangements should be made Pollution Prevention Division (7511P), Register date and page number). for deliveries of boxed information. The Office of Pesticide Programs, ii. Follow directions. The Agency may Docket Facility telephone number is Environmental Protection Agency, 1200 ask you to respond to specific questions (703) 305–5805. or organize comments by referencing a Instructions: Direct your comments to Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: Code of Federal Regulations (CFR) part docket ID number EPA–HQ–OPP–2009– or section number. 0917 and the pesticide petition number (703) 347–8496; e-mail address: [email protected]. iii. Explain why you agree or disagree; (PP 9F7645). EPA’s policy is that all suggest alternatives and substitute comments received will be included in SUPPLEMENTARY INFORMATION: language for your requested changes. the docket without change and may be I. General Information iv. Describe any assumptions and made available on-line at http:// provide any technical information and/ www.regulations.gov, including any A. Does this Action Apply to Me? or data that you used. personal information provided, unless You may be potentially affected by v. If you estimate potential costs or the comment includes information this action if you are an agricultural burdens, explain how you arrived at claimed to be Confidential Business producer, food manufacturer, or your estimate in sufficient detail to Information (CBI) or other information pesticide manufacturer. Potentially allow for it to be reproduced. whose disclosure is restricted by statute. affected entities may include, but are vi. Provide specific examples to Do not submit information that you not limited to: illustrate your concerns and suggest consider to be CBI or otherwise • Crop production (NAICS code 111). alternatives. protected through regulations.gov or e- • Animal production (NAICS code vii. Explain your views as clearly as mail. The regulations.gov website is an 112). possible, avoiding the use of profanity ‘‘anonymous access’’ system, which • Food manufacturing (NAICS code or personal threats. means EPA will not know your identity 311). viii. Make sure to submit your or contact information unless you • Pesticide manufacturing (NAICS comments by the comment period provide it in the body of your comment. code 32532). deadline identified. If you send an e-mail comment directly This listing is not intended to be 3. Environmental justice. EPA seeks to to EPA without going through exhaustive, but rather provides a guide achieve environmental justice, the fair regulations.gov, your e-mail address for readers regarding entities likely to be treatment and meaningful involvement will be automatically captured and affected by this action. Other types of of any group, including minority and/or included as part of the comment that is entities not listed in this unit could also low-income populations, in the placed in the docket and made available be affected. The North American development, implementation, and on the Internet. If you submit an Industrial Classification System enforcement of environmental laws, electronic comment, EPA recommends (NAICS) codes have been provided to regulations, and policies. To help that you include your name and other assist you and others in determining address potential environmental justice contact information in the body of your whether this action might apply to issues, the Agency seeks information on comment and with any disk or CD-ROM certain entities. If you have any any groups or segments of the you submit. If EPA cannot read your questions regarding the applicability of population who, as a result of their comment due to technical difficulties this action to a particular entity, consult location, cultural practices, or other and cannot contact you for clarification, the person listed under FOR FURTHER factors, may have atypical or EPA may not be able to consider your INFORMATION CONTACT. disproportionately high and adverse comment. Electronic files should avoid human health impacts or environmental B. What Should I Consider as I Prepare the use of special characters, any form effects from exposure to the pesticides My Comments for EPA? of encryption, and be free of any defects discussed in this document, compared or viruses. 1. Submitting CBI. Do not submit this to the general population. Docket: All documents in the docket information to EPA through are listed in the docket index available regulations.gov or e-mail. Clearly mark II. What Action is the Agency Taking? at http://www.regulations.gov. Although the part or all of the information that EPA is announcing receipt of a listed in the index, some information is you claim to be CBI. For CBI pesticide petition filed under section not publicly available, e.g., CBI or other information in a disk or CD-ROM that 408 of the Federal Food, Drug, and

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Cosmetic Act (FFDCA), 21 U.S.C. 346a, ENVIRONMENTAL PROTECTION www.regulations.gov, including any proposing the establishment of a AGENCY personal information provided, unless the comment includes information regulation in 40 CFR part 180 for [EPA–HQ–OPP–2009–0135; FRL–8804–9] residues of polymeric polyhydroxy acid claimed to be Confidential Business in or on all food commodities. EPA has Notice of Receipt of Requests to Information (CBI) or other information determined that the pesticide petition Voluntarily Cancel Certain Pesticide whose disclosure is restricted by statute. described in this notice contains data or Registrations Do not submit information that you information prescribed in FFDCA consider to be CBI or otherwise AGENCY: section 408(d)(2); however, EPA has not Environmental Protection protected through regulations.gov or e- Agency (EPA). fully evaluated the sufficiency of the mail. The regulations.gov website is an submitted data at this time or whether ACTION: Notice. ‘‘anonymous access’’ system, which the data supports granting of the means EPA will not know your identity SUMMARY: In accordance with section or contact information unless you pesticide petition. Additional data may 6(f)(1) of the Federal Insecticide, provide it in the body of your comment. be needed before EPA can make a final Fungicide, and Rodenticide Act If you send an e-mail comment directly determination on this pesticide petition. (FIFRA), as amended, EPA is issuing a to EPA without going through Pursuant to 40 CFR 180.7(f), a notice of receipt of request by registrants regulations.gov, your e-mail address summary of the petition that is the to voluntarily cancel certain pesticide will be automatically captured and subject of this notice, prepared by the registrations. included as part of the comment that is petitioner, is included in a docket EPA DATES: Unless a request is withdrawn by placed in the docket and made available has created for this rulemaking. The July 12, 2010 or February 12, 2010 for on the Internet. If you submit an docket for this petition is available on- registrations for which the registrant electronic comment, EPA recommends line at http://www.regulations.gov. requested a waiver of the 180–day that you include your name and other As specified in FFDCA section comment period, orders will be issued contact information in the body of your comment and with any disk or CD-ROM 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is canceling these registrations. The you submit. If EPA cannot read your publishing notice of the petition so that Agency will consider withdrawal comment due to technical difficulties the public has an opportunity to requests postmarked no later than July 12, 2010 or February 12, 2010, and cannot contact you for clarification, comment on this request for the whichever is applicable. Comments EPA may not be able to consider your establishment of a regulation for must be received on or before July 12, comment. Electronic files should avoid residues of the pesticide in or on all 2010 or February 12, 2010, for those the use of special characters, any form food commodities. Further information registrations where the 180–day of encryption, and be free of any defects on the petition may be obtained through comment period has been waived. or viruses. the petition summary referenced in this ADDRESSES: Submit your comments and Docket: All documents in the docket unit. your withdrawal request, identified by are listed in the docket index available PP 9F7645. Floratine Biosciences, docket identification (ID) number EPA– in regulations.gov. To access the Inc., 153 N. Main Street, Suite 100, HQ–OPP–2009–0135, by one of the electronic docket, go to http:// Collierville, TN 38017, proposes to following methods: www.regulations.gov, select ‘‘Advanced establish an exemption from the • Federal eRulemaking Portal: http:// Search,’’ then ‘‘Docket Search.’’ Insert the requirement of a tolerance for residues www.regulations.gov. Follow the on-line docket ID number where indicated and of the plant growth regulator, polymeric instructions for submitting comments. select the ‘‘Submit’’ button. Follow the polyhydroxy acid, in or on all food • Mail: Office of Pesticide Programs instructions on the regulations.gov commodities. The petitioner believes no (OPP) Regulatory Public Docket (7502P), website to view the docket index or access available documents. Although analytical method is needed because Environmental Protection Agency, 1200 listed in the index, some information is this is an exemption from the Pennsylvania Ave., NW., Washington, DC 20460–0001. Written Withdrawal not publicly available, e.g., CBI or other requirement of a tolerance without any information whose disclosure is numerical limitation. Request, Attention: John Jamula, Information Technology and Resources restricted by statute. Certain other material, such as copyrighted material, List of Subjects Management Division (7502P). • Delivery: OPP Regulatory Public is not placed on the Internet and will be Environmental protection, Docket (7502P), Environmental publicly available only in hard copy Agricultural commodities, Feed Protection Agency, Rm. S–4400, One form. Publicly available docket additives, Food additives, Pesticides Potomac Yard (South Bldg.), 2777 S. materials are available either in the and pests, Reporting and recordkeeping Crystal Dr., Arlington, VA. Deliveries electronic docket at http:// www.regulations.gov, or, if only requirements. are only accepted during the Docket’s normal hours of operation (8:30 a.m. to available in hard copy, at the OPP Dated: January 5, 2010. 4 p.m., Monday through Friday, Regulatory Public Docket in Rm. S– Keith A. Matthews, excluding legal holidays). Special 4400, One Potomac Yard (South Bldg.), Acting Director, Biopesticides and Pollution arrangements should be made for 2777 S. Crystal Dr., Arlington, VA. The Prevention Division, Office of Pesticide deliveries of boxed information. The hours of operation of this Docket Programs. Docket Facility telephone number is Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal [FR Doc. 2010–490; Filed 1–12–10; 8:45 am] (703) 305–5805. Instructions: Direct your comments to holidays. The Docket Facility telephone BILLING CODE 6560–50–S docket ID number EPA–HQ–OPP–2009– number is (703) 305–5805. 0135. EPA’s policy is that all comments FOR FURTHER INFORMATION CONTACT: John received will be included in the docket Jamula, Information Technology and without change and may be made Resource Management Division, Office available on-line at http:// of Pesticide Programs, Environmental

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Protection Agency, 1200 Pennsylvania you mail to EPA, mark the outside of the iv. Describe any assumptions and Ave., NW., Washington, DC 20460– disk or CD-ROM as CBI and then provide any technical information and/ 0001; telephone number: (703) 305– identify electronically within the disk or or data that you used. 6426; e-mail address: CD-ROM the specific information that is v. If you estimate potential costs or claimed as CBI. In addition to one [email protected]. burdens, explain how you arrived at complete version of the comment that SUPPLEMENTARY INFORMATION: your estimate in sufficient detail to includes information claimed as CBI, a I. General Information copy of the comment that does not allow for it to be reproduced. vi. Provide specific examples to A. Does this Action Apply to Me? contain the information claimed as CBI must be submitted for inclusion in the illustrate your concerns and suggest This action is directed to the public public docket. Information so marked alternatives. in general. Although this action may be will not be disclosed except in of particular interest to persons who vii. Explain your views as clearly as accordance with procedures set forth in possible, avoiding the use of profanity produce or use pesticides, the Agency 40 CFR part 2. or personal threats. has not attempted to describe all the 2. Tips for preparing your comments. specific entities that may be affected by When submitting comments, remember viii. Make sure to submit your this action. If you have any questions to: comments by the comment period regarding the information in this notice, i. Identify the document by docket ID deadline identified. consult the person listed under FOR number and other identifying FURTHER INFORMATION CONTACT. information (subject heading, Federal II. What Action is the Agency Taking? Register date and page number). This notice announces receipt by the B. What Should I Consider as I Prepare ii. Follow directions. The Agency may Agency of applications from registrants My Comments for EPA? ask you to respond to specific questions to cancel 81 pesticide products 1. Submitting CBI. Do not submit this or organize comments by referencing a information to EPA through Code of Federal Regulations (CFR) part registered under section 3 or 24(c) of regulations.gov or e-mail. Clearly mark or section number. FIFRA. These registrations are listed in the part or all of the information that iii. Explain why you agree or disagree; sequence by registration number (or you claim to be CBI. For CBI suggest alternatives and substitute company number and 24(c) number) in information in a disk or CD-ROM that language for your requested changes. Table 1 of this unit:

TABLE 1.—REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION

Registration no. Product Name Chemical Name

000228–00640 Imida E-Pro 0.50% Insecticide Plus Turf Imidacloprid Fertilizer

000228–00641 Imida E-Pro 0.30% Insecticide Plus Turf Imidacloprid Fertilizer

000228–00642 Imida E-Pro 0.25% Insecticide Plus Turf Imidacloprid Fertilizer

000228–00643 Imida E-Pro 0.20% Insecticide Plus Turf Imidacloprid Fertilizer

000228–00644 Imida E-Pro 0.15% Insecticide Plus Turf Imidacloprid Fertilizer

000241 AR–04–0003 Beyond Herbicide Imazamox

000264 LA–04–0002 Aztec 2.1% Granular Insecticide Phostebupirim

Cyfluthrin

000264 LA–04–0010 Aztec 4.67g Granular Insecticide Cyfluthrin

Phostebupirim

000264 MS–04–0001 Aztec 2.1% Granular Insecticide Cyfluthrin

Phostebupirim

000264 MS–04–0006 Aztec 4.67% Granular Cyfluthrin

Phostebupirim

000264 MS–06–0003 Defcon 2.1G Cyfluthrin

Phostebupirim

000264 TX–03–0010 Aztec 2.1% Granular Insecticide Phostebupirim

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TABLE 1.—REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION—Continued

Registration no. Product Name Chemical Name

Cyfluthrin

000264 TX–04–0024 Aztec 4.67% Granular Insecticide Cyfluthrin

Phostebupirim

000264 WA–94–0001 Rovral Fungicide Iprodione

000538–00096 Scotts Lawn Disease Preventer Pentachloronitrobenzene

000538–00116 Scotts Lawn Disease Preventer Plus Fer- Pentachloronitrobenzene tilizer

000538–00194 Proturf Fertilizer Plus Fungicide VIII Thiophanate-methyl

Iprodione

000769–00978 Allpro Baracide 5ps Pelleted Herbicide Simazine

Sodium chlorate

Prometon

Boric acid (HBO2), sodium salt

000802–00593 Lilly/Miller Ready-To-Use Bug-Off Piperonyl butoxide

Pyrethrins

000829–00200 SA-50 Brand Sevin 10% Dust Carbaryl

000961–00383 Par Ex Slow Release Fertilizer Plus Snow Pentachloronitrobenzene Mold Control

002749 ID–05–0004 Sprout Nip Briquette Chlorpropham

004822–00487 Snake 1 d-trans-Chrysanthemum monocarboxylic ester of dl-2-allyl-4-hy- droxy-3-methyl-2-cyclopenten-1-

004822–00532 Raid Reach & Kill Indoor Ant & Roach Kill- Cypermethrin er

005481 LA–01–0008 Aztec 4.67% Granular Phostebupirim

Cyfluthrin

005481 OR–00–0020 Orthene 97 Pellets Acephate

005481 OR–97–0006 Orthene 75 S Soluble Powder Acephate

005481 TX–04–0001 Aztec 4.67% Granular Cyfluthrin

Phostebupirim

005905 LA–06–0002 Defcon 2.1%G Phostebupirim

Cyfluthrin

007401–00163 Ferti - Lome A-C-G Insecticide & Fungicide Malathion

Pentachloronitrobenzene

007401–00372 Ferti-Loam Whitefly & Mealybug Killer Aliphatic petroleum solvent

Resmethrin

007401–00389 Hi-Yield Terraclor Fungicide Pentachloronitrobenzene

007401–00433 3 Way Dust Garden Insecticide Rotenone

Sulfur

034704 CA–96–0009 Coastox Carbaryl Cutworm Bait Carbaryl

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TABLE 1.—REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION—Continued

Registration no. Product Name Chemical Name

042964–00016 Aquinoc Resmethrin

043813–00022 Fungaflor 100 SL Imazalil sulphate

048273–00017 Marman Pcnb 75% WP Pentachloronitrobenzene

053883–00204 IMI 0.22% G Imidacloprid

053883–00206 IMI 0.22% G Rose, Flower & Shrub Insec- Imidacloprid ticide

053883–00215 IMI 0.2 Plus Imidacloprid

061483–00062 Vulcan Glazd Penta Pentachlorophenol

062719–00222 Broadstrike + Treflan Trifluralin

Flumetsulam

062719–00286 Starane Fluroxypyr 1-methylheptyl ester

062719 CA–05–0016 Kerb 50W Propyzamide

062719 CA–07–0016 Intrepid 2F Methoxyfenozide

062719 CA–86–0065 Kerb 50–W Herbicide (in Water Soluble Propyzamide Pouches)

062719 CA–94–0013 Lorsban 4E-HF Chlorpyrifos

062719 CA–94–0015 Lorsban 4E-HF Chlorpyrifos

062719 CA–94–0016 Lorsban 4E-HF Chlorpyrifos

062719 CA–95–0015 Lorsban-4E Chlorpyrifos

062719 FL–94–0003 Lorsban 4E-HF Chlorpyrifos

062719 HI–07–0002 Lorsban-4E Chlorpyrifos

062719 ID–95–0013 Lorsban-4E Chlorpyrifos

062719 ID–99–0019 Lorsban-4E Chlorpyrifos

062719 LA–07–0002 Lorsban-4E Chlorpyrifos

062719 MI–04–0004 Propiconazole EC Propiconazole

062719 MS–06–0017 Lorsban-4E Chlorpyrifos

062719 NC–07–0001 Lorsban-4E Chlorpyrifos

062719 OR–05–0015 Lorsban-4E Chlorpyrifos

062719 OR–94–0028 Lorsban 4E-HF Chlorpyrifos

062719 OR–94–0030 Lorsban 4E-HF Chlorpyrifos

062719 OR–94–0031 Lorsban 4E-HF Chlorpyrifos

062719 OR–94–0033 Lorsban 4E-HF Chlorpyrifos

062719 OR–95–0009 Lorsban-4E Chlorpyrifos

062719 OR–97–0009 Lorsban-4E Chlorpyrifos

062719 OR–99–0057 Lorsban-4E Chlorpyrifos

062719 WA–04–0018 NAF-522 Glyphosate-isopropylammonium

062719 WA–05–0012 Lorsban-4E Chlorpyrifos

062719 WA–94–0002 Lorsban 4E-HF Chlorpyrifos

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TABLE 1.—REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION—Continued

Registration no. Product Name Chemical Name

062719 WA–97–0008 Lorsban-4E Chlorpyrifos

062719 WA–97–0012 Lorsban-4E Chlorpyrifos

062719 WA–99–0015 Lorsban-4E Chlorpyrifos

067517–00002 Malathion Spray Malathion

070506–00192 Knox Out Nl Diazinon

072871 MO–99–0005 Dylox 80 Turf and Ornamental Insecticide Trichlorfon

083399–00004 SVP5 Dinotefuran

084467–00001 Proparmite Technical Propargite

084467–00002 Antimite(tm)-6.5EC Propargite

084467–00003 Proparmite (tm) -6EC Propargite

084467–00004 Proparmite (tm)-30WSP Propargite

084467–00005 Proparmite(tm)-6E Propargite

A request to waive the 180–day TABLE 2—REGISTRANTS REQUESTING TABLE 2—REGISTRANTS REQUESTING comment period has been received for VOLUNTARY CANCELLATION—Con- VOLUNTARY CANCELLATION—Con- the following registrations: 000228– tinued tinued 00640; 000228–00641; 000228–00642; 000228–00643;000228–00644; 000538– EPA Com- Company Name and Address EPA Com- Company Name and Address 00096; 000538–00116; 000769–00978; pany no. pany no. 000961–00383; 004822–00487; 004822– 000241 BASF Corp., 002749 Aceto Agricultural Chemicals 00532; 007401–00163; 007401–00372; P.O. Box 13528, Corp., 007401–00389; 007401–00433; 043813– Research Triangle Park, NC One Hollow Lane, 00022; 048273–00017; 061483–00062; 27709–3528. Lake Success, NY 11042–1215. 062719–00286; 067517–00002; 070506– 00192; 084467–00001; 084467–00002; 00264 Bayer Cropscience LP, 004822 S.C. Johnson & Son Inc., 084467–00003; 084467–00004; 084467– 2 T.W. Alexander Drive, 1525 Howe Street, 00005. Research Triangle Park, NC Racine, WI 53403. 27709. Unless a request is withdrawn by the 005481 Amvac Chemical Corp., d/b/a registrant within 180 days of 000538 The Scotts Co., Amvac, publication of this notice, orders will be 14111 Scottslawn Rd, 4695 Macarthur Ct., issued canceling all of these Marysville, OH 43041. Suite 1250, NewP.O.rt Beach, CA 92660– registrations. Users of these pesticides 000769 Value Gardens Supply, LLC, d/ 1706. or anyone else desiring the retention of b/a Value Garden Supply, a registration should contact the P.O. Box 585, 005905 Helena Chemical Co, applicable registrant directly during this Saint Joseph, MO 64502. 7664 Moore Rd., 180–day period. Memphis, TN 38120. 000802 Registrations By Design, Inc., Table 2 of this unit includes the Agent For: Lilly Miller Brands, 007401 Mandava Associates, LLC, names and addresses of record for all P.O. Box 1019, Agent For: Voluntary Pur- registrants of the products in Table 1 of Salem, VA 24153–3805. chasing Groups, Inc., this unit, in sequence by EPA company 6860 N. Dallas Pkwy., number: 000829 Southern Agricultural Insecti- Suite 200, cides, Inc., Plano, TX 75024. P.O. Box 218, ABLE EGISTRANTS EQUESTING T 2—R R Palmetto, FL 34220. 034704 Loveland Products, Inc., VOLUNTARY CANCELLATION Attn: Mark R. Trostle 000961 Product & Regulatory Associ- P.O. Box 1286, Greeley, CO EPA Com- Company Name and Address ates, LLC, Agent For: Leb- 80632–1286.. pany no. anon Seaboard Corp., P.O. Box 351, 042964 Airkem Professional Products, 000228 Nufarm Americas Inc., Vorhees, NJ 08043. Division of Ecolab, Inc., 150 Harvester Drive, 370 North Wabasha Street, Suite 200, St. Paul, MN 55102. Burr Ridge, IL 60527.

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TABLE 2—REGISTRANTS REQUESTING IV. Procedures for Withdrawal of List of Subjects VOLUNTARY CANCELLATION—Con- Request Environmental protection, Pesticides tinued Registrants who choose to withdraw a and pests. EPA Com- request for cancellation must submit Dated: December 29, 2009. Company Name and Address such withdrawal in writing to the pany no. Katheryn S. Bouve´, person listed under FOR FURTHER Acting Director, Information Technology and 043813 Janssen PMP, Janssen INFORMATION CONTACT, postmarked Pharmaceutica NV, Resources Management Division, Office of before July 12, 2010. This written Pesticide Programs. 1125 Trenton-Harbourton Rd, withdrawal of the request for Titusville, NJ 08560–0200. cancellation will apply only to the [FR Doc. 2010–272 Filed 1–12–10; 8:45 am] 048273 Nufarm Inc., Agent For: Marman applicable FIFRA section 6(f)(1) request BILLING CODE 6560–50–S USA Inc., listed in this notice. If the product(s) 150 Harvester Drive have been subject to a previous Suite 200, cancellation action, the effective date of Burr Ridge, IL 60527. cancellation and all other provisions of FARM CREDIT SYSTEM INSURANCE any earlier cancellation action are 053883 Control Solutions, Inc., CORPORATION 5903 Genoa-Red Bluff Rd., controlling. The withdrawal request Pasadena, TX 77507–1041. must also include a commitment to pay Meetings any reregistration fees due, and to fulfill AGENCY: Farm Credit System Insurance 061483 KMG-Bernuth, Inc., any applicable unsatisfied data Corporation Board; Regular Meeting. 9555 W. Sam Houston Pkwy requirements. South, SUMMARY: Notice is hereby given of the Suite 600, V. Provisions for Disposition of Existing regular meeting of the Farm Credit Houston, TX 77099. Stocks System Insurance Corporation Board (Board). 062719 Dow Agrosciences LLC, The effective date of cancellation will 9330 Zionsville Rd 308/2E, be the date of the cancellation order. DATE AND TIME: The meeting of the Board IndianaP.O.lis, IN 46268–1054. The orders effecting these requested will be held at the offices of the Farm cancellations will generally permit a Credit Administration in McLean, 067517 Virbbac AH, Inc., Agent For: PM registrant to sell or distribute existing Virginia, on January 21, 2010, from 9 Resources Inc., a.m. until such time as the Board stocks for 1 year after the date the P.O. Box 162059, concludes its business. Fort Worth, TX 76161. cancellation request was received. This policy is in accordance with the FOR FURTHER INFORMATION CONTACT: 070506 United Phosphorus, Inc., Agency’s statement of policy as Roland E. Smith, Secretary to the Farm 630 Freedom Business Center, prescribed in the Federal Register of Credit System Insurance Corporation Suite 402, June 26, 1991 (56 FR 29362) (FRL– Board, (703) 883–4009, TTY (703) 883– King Of Prussia, PA 19406. 3846–4). Exceptions to this general rule 4056. ADDRESSES: 072871 Missouri Aquaculture Associa- will be made if a product poses a risk Farm Credit System tion, concern, or is in noncompliance with Insurance Corporation, 1501 Farm P.O. Box 630, reregistration requirements, or is subject Credit Drive, McLean, Virginia 22102. Jefferson City, MO 65102–6864. to a data call-in. In all cases, product- SUPPLEMENTARY INFORMATION: Parts of specific disposition dates will be given this meeting of the Board will be open 083399 Summit Vetpharm, LLC, in the cancellation orders. to the public (limited space available) 301 Route 17 North (12th and parts will be closed to the public. Floor), Existing stocks are those stocks of Rutherford, NJ 07070. registered pesticide products which are In order to increase the accessibility to currently in the United States and Board meetings, persons requiring 084467 UPI-Aceto, LLC, which have been packaged, labeled, and assistance should make arrangements in advance. The matters to be considered 630 Freedom Business Center, released for shipment prior to the Suite 402, at the meeting are: King Of Prussia, PA 19406. effective date of the cancellation action. Unless the provisions of an earlier order Open Session apply, existing stocks already in the III. What is the Agency’s Authority for A. Approval of Minutes hands of dealers or users can be Taking this Action? distributed, sold, or used legally until • December 10, 2009 (Open and Section 6(f)(1) of FIFRA provides that they are exhausted, provided that such Closed) a registrant of a pesticide product may further sale and use comply with the B. New Business at any time request that any of its EPA-approved label and labeling of the • Review of Insurance Premium Rates pesticide registrations be canceled. affected product. Exception to these FIFRA further provides that, before general rules will be made in specific Closed Session cases when more stringent restrictions acting on the request, EPA must publish • Update on System Institution Risk a notice of receipt of any such request on sale, distribution, or use of the in the Federal Register. Thereafter, the products or their ingredients have Dated: January 7, 2010. Administrator may approve such a already been imposed, as in a special Roland E. Smith, request. review action, or where the Agency has Secretary, Farm Credit System Insurance identified significant potential risk Corporation Board. concerns associated with a particular [FR Doc. 2010–406 Filed 1–12–10; 8:45 am] chemical. BILLING CODE 6710–01–P

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FEDERAL COMMUNICATIONS in the ’’Select Agency’’ box below the provide to interexchange carriers (IXCs) COMMISSION ’’Currently Under Review’’ heading, (4) a quarterly report listing payphone select ’’Federal Communications ANIs. Without provision of this report, Notice of Public Information Collection Commission’’ from the list of agencies resolution of disputed ANIs would be Being Submitted for Review to the presented in the ’’Select Agency’’ box, rendered very difficult. IXCs would not Office of Management and Budget (5) click the ’’Submit’’ button to the right be able to discern which ANIs pertain (OMB), Comments Requested of the ’’Select Agency’’ box, and (6) to payphones and therefore would not be able to ascertain which dial–around January 7, 2010. when the FCC list appears, look for the title of this ICR (or its OMB Control calls were originated by payphones for SUMMARY: The Federal Communications compensation purposes. There would be Commission, as part of its continuing Number, if there is one) and then click no way to guard against possible fraud. effort to reduce paperwork burden on the ICR. Without this collection, lengthy invites the general public and other FOR FURTHER INFORMATION CONTACT: investigations would be necessary to Federal agencies to take this Judith B. Herman, OMD, 202–418–0214. verify claims. The report allows IXCs to opportunity to comment on the For additional information about the determine which dial–around calls are following information collection(s), as information collection(s) send an e–mail made from payphones. The data which required by the Paperwork Reduction to [email protected] or contact Judith B. must be maintained for at least 18 Act of 1995, 44 U.S.C. 3501–3520. Herman, 202–418–0214. months after the close of the Comments are requested concerning (a) SUPPLEMENTARY INFORMATION: compensation period, will facilitate whether the proposed collection of OMB Control No: 3060–0719. verification of disputed ANIs. information is necessary for the proper Title: Quarterly Report of IntraLATA performance of the functions of the Carriers Listing Payphone Automatic Federal Communications Commission. Commission, including whether the Number Identifications (ANIs). Marlene H. Dortch, information shall have practical utility; Form No.: N/A. Secretary, Office of the Secretary, Office of (b) the accuracy of the Commission’s Type of Review: Extension of a Managing Director. burden estimate; (c) ways to enhance currently approved collection. [FR Doc. 2010–396 Filed 1–12–10; 8:45 am] the quality, utility, and clarity of the Respondents: Business or other for– BILLING CODE 6712–01–S information collected; (d) ways to profit. minimize the burden of the collection of Number of Respondents: 400 information on the respondents, respondents; 1,600 responses. FEDERAL COMMUNICATIONS including the use of automated Estimated Time Per Response: 3.5 COMMISSION collection techniques or other forms of hours (8 hours for initial submission; 2 information technology; and (e) ways to hours per subsequent submission – for Notice of Public Information Collection further reduce the information burden an average of 3.5 hours per response). Being Submitted to the Office of for small business concerns with fewer Frequency of Response: Quarterly Management and Budget (OMB) for than 25 employees. reporting requirement, recordkeeping Review, Comments Requested The FCC may not conduct or sponsor requirement and third party disclosure January 7, 2010. a collection of information unless it requirement. SUMMARY: The Federal Communications displays a currently valid control Obligation to Respond: Mandatory. Commission, as part of its continuing number. No person shall be subject to Statutory authority for this collection of effort to reduce paperwork burden any penalty for failing to comply with information is contained in 47 U.S.C. invites the general public and other a collection of information subject to the sections 151, 154, 201–205, 215,218, Federal agencies to take this Paperwork Reduction Act (PRA) that 219, 220, 226 and 276. opportunity to comment on the does not display a valid control number. Total Annual Burden: 5,600 hours. following information collection(s), as DATES: Persons wishing to comments on Privacy Act Impact Assessment: N/A. required by the Paperwork Reduction this information collection should Nature and Extent of Confidentiality: Act of 1995, 44 U.S.C. 3501–3520. submit comments on or before February The Commission is not requesting Comments are requested concerning (a) 12, 2010. If you anticipate that you will respondents to submit confidential whether the proposed collection of be submitting comments, but find it information to the Commission. If the information is necessary for the proper difficult to do so within the period of respondent wishes confidential performance of the functions of the time allowed by this notice, you should treatment of their information, they may Commission, including whether the advise the contact listed below as soon request confidential treatment under 47 information shall have practical utility; as possible. CFR 0.459 of the Commission’s rules. (b) the accuracy of the Commission’s ADDRESSES: Direct all PRA comments to Need and Uses: The Commission is burden estimate; (c) ways to enhance Nicholas A. Fraser, Office of submitting this expiring information the quality, utility, and clarity of the Management and Budget (OMB), via fax collection to the Office of Management information collected; (d) ways to at (202) 395–5167, or via the Internet at and Budget (OMB) in order to obtain the minimize the burden of the collection of [email protected] and full three year clearance from them. information on the respondents, to Judith B. Herman, Federal There is no change in the reporting, including the use of automated Communications Commission (FCC). To recordkeeping and/or third party collection techniques or other forms of submit your PRA comments by e–mail disclosure requirements. information technology; and (e) ways of send them to: [email protected]. Pursuant to the mandate in section reducing the information burden for To view a copy of this information 276(b)(1)(A) of the Telecommunications small business concerns with fewer than collection request (ICR) submitted to Act of 1996 to ‘‘establish a per call 25 employees. OMB: (1) Go to web page: http:// compensation plan to ensure that all The FCC may not conduct or sponsor www.reginfo.gov/public/do/PRAMain, payphone service providers are fairly a collection of information unless it (2) look for the section of the web page compensated for each and every displays a currently valid control called ’’Currently Under Review’’, (3) completed intrastate and interstate call.’’ number. No person shall be subject to click on the downward–pointing arrow IntraLATA carriers are required to any penalty for failing to comply with

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a collection of information subject to the information is contained in 47 U.S.C. information shall have practical utility; Paperwork Reduction Act (PRA) that section 276 of the Telecommunications (b) the accuracy of the Commission’s does not display a valid control number. Act of 1996. burden estimate; (c) ways to enhance DATES: Persons wishing to comments on Total Annual Burden: 118,137 hours. the quality, utility, and clarity of the this information collection should Privacy Act Impact Assessment: N/A. information collected; (d) ways to submit comments on or before February Nature and Extent of Confidentiality: minimize the burden of the collection of 12, 2010. If you anticipate that you will The Commission is not requesting information on the respondents, be submitting comments, but find it respondents to submit confidential including the use of automated difficult to do so within the period of information to the agency. However, if collection techniques or other forms of time allowed by this notice, you should the respondents wish to request information technology; and (e) ways to confidential treatment of their advise the contact listed below as soon further reduce the information burden information, they may do so under 47 as possible. for small business concerns with fewer CFR 0.459 of the Commission’s rules. than 25 employees. ADDRESSES: Direct all PRA comments to Need and Uses: This collection of The FCC may not conduct or sponsor Nicholas A. Fraser, Office of information implements the following a collection of information unless it Management and Budget (OMB), via fax requirements under section 276 of the displays a currently valid control at (202) 395–5167, or via the Internet at Telecommunications Act of 1996. They _ _ number. No person shall be subject to Nicholas A. [email protected] and are: a) state showing of proof of market any penalty for failing to comply with to Judith B. Herman, Federal failure for exception to market–rate a collection of information subject to the Communications Commission (FCC). To local coin call requirement; b) state Paperwork Reduction Act (PRA) that submit your PRA comments by e–mail review of adequacy of provision of does not display a valid control number. send them to: [email protected]. public interest payphone; c) payphone To view a copy of this information providers’ transmission of specific DATES: Persons wishing to comments on collection request (ICR) submitted to payphone coding digits; d) LEC this information collection should OMB: (1) Go to web page: http:// verification of disputed ANIS and submit comments on or before February www.reginfo.gov/public/do/PRAMain, maintaining and making available the 12, 2010. If you anticipate that you will (2) look for the section of the web page verification data; e) LEC timely be submitting comments, but find it called ’’Currently Under Review’’, (3) notification of payphone disconnection; difficult to do so within the period of click on the downward–pointing arrow f) LEC indication on the payphone’s time allowed by this notice, you should in the ’’Select Agency’’ box below the monthly bill that the amount due is for advise the contact listed below as soon ’’Currently Under Review’’ heading, (4) payphone service; g) LEC tariff filing; h) as possible. select ’’Federal Communications reclassification of LEC–owned ADDRESSES: Direct all PRA comments to Commission’’ from the list of agencies payphones; i) payphone provider’s Nicholas A. Fraser, Office of presented in the ’’Select Agency’’ box, verification of its status to payer of Management and Budget (OMB), via fax (5) click the ’’Submit’’ button to the right compensation; j) payphone providers’ at (202) 395–5167, or via the Internet at of the ’’Select Agency’’ box, and (6) posting of local coin call rate on each [email protected] and when the FCC list appears, look for the payphone placard; and k) LEC provision to Judith B. Herman, Federal title of this ICR (or its OMB Control of emergency numbers to carrier–payers. Communications Commission (FCC). To Number, if there is one) and then click Federal Communications Commission. submit your PRA comments by e–mail on the ICR. Marlene H. Dortch, send them to: [email protected]. FOR FURTHER INFORMATION CONTACT: To view a copy of this information Judith B. Herman, OMD, 202–418–0214. Secretary, Office of the Secretary, Office of Managing Director. collection request (ICR) submitted to For additional information about the [FR Doc. 2010–402 Filed 1–12–10; 8:45 am] OMB: (1) Go to web page: http:// information collection(s) send an e–mail www.reginfo.gov/public/do/PRAMain, BILLING CODE 6712–01–S to [email protected] or contact Judith B. (2) look for the section of the web page Herman, 202–418–0214. called ’’Currently Under Review’’, (3) SUPPLEMENTARY INFORMATION: FEDERAL COMMUNICATIONS click on the downward–pointing arrow OMB Control No: 3060–0743. COMMISSION in the ’’Select Agency’’ box below the Title: Implementation of the Pay ’’Currently Under Review’’ heading, (4) Telephone Reclassification and Notice of Public Information Collection select ’’Federal Communications Compensation Provisions of the Being Submitted for Review to the Commission’’ from the list of agencies Telecommunications Act of 1996, CC Office of Management and Budget presented in the ’’Select Agency’’ box, Docket No. 96–128. (OMB), Comments Requested (5) click the ’’Submit’’ button to the right Form No.: N/A. of the ’’Select Agency’’ box, and (6) Type of Review: Extension of a January 7, 2010. when the FCC list appears, look for the currently approved collection. SUMMARY: The Federal Communications title of this ICR (or its OMB Control Respondents: Business or other for– Commission, as part of its continuing Number, if there is one) and then click profit. effort to reduce paperwork burden on the ICR. Number of Respondents: 4,471 invites the general public and other FOR FURTHER INFORMATION CONTACT: respondents; 10,071 responses. Federal agencies to take this Estimated Time Per Response: .50 to opportunity to comment on the Judith B. Herman, OMD, 202–418–0214. 100 hours. following information collection(s), as For additional information about the Frequency of Response: On occasion, required by the Paperwork Reduction information collection(s) send an e–mail monthly and quarterly reporting Act of 1995, 44 U.S.C. 3501–3520. to [email protected] or contact Judith B. requirements, recordkeeping Comments are requested concerning (a) Herman, 202–418–0214. requirement and third party disclosure whether the proposed collection of SUPPLEMENTARY INFORMATION: requirement. information is necessary for the proper OMB Control No: 3060–0952. Obligation to Respond: Mandatory. performance of the functions of the Title: Proposed Demographic Statutory authority for this collection of Commission, including whether the Information and Notifications, Second

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Further Notice of Proposed Rulemaking invites the general public and other FOR FURTHER INFORMATION CONTACT: (FNPRM), CC Docket No. 98–147. Federal agencies to take this Judith B. Herman, OMD, 202–418–0214. Form No.: N/A. opportunity to comment on the For additional information about the Type of Review: Extension of a following information collection(s), as information collection(s) send an e–mail currently approved collection. required by the Paperwork Reduction to [email protected] or contact Judith B. Respondents: Business or other for– Act of 1995, 44 U.S.C. 3501–3520. Herman, 202–418–0214. profit. Comments are requested concerning (a) SUPPLEMENTARY INFORMATION: Number of Respondents: 1,400 whether the proposed collection of OMB Control No: 3060–0292. respondents; 1,400 responses. information is necessary for the proper Title: Section 69.605, Reporting and Estimated Time Per Response: 2 hours performance of the functions of the Distribution of Pool Access Revenues, (2 filings per year). Commission, including whether the Frequency of Response: On occasion Part 69, Access Charges. information shall have practical utility; Form No.: N/A. reporting requirement and third party (b) the accuracy of the Commission’s disclosure requirement. Type of Review: Extension of a burden estimate; (c) ways to enhance currently approved collection. Obligation to Respond: Mandatory. the quality, utility, and clarity of the Statutory authority for this information Respondents: Business or other for– information collected; (d) ways to profit. collection is contained in 47 U.S.C. minimize the burden of the collection of sections 151–154, 201, 202, 251–254, Number of Respondents: 1,250 information on the respondents, respondents; 15,000 responses. 256, 271 and 303(r). including the use of automated Total Annual Burden: 5,600 hours. Estimated Time Per Response: .75 collection techniques or other forms of Privacy Act Impact Assessment: N/A. hours (45 minutes) x 12 monthly Nature and Extent of Confidentiality: information technology; and (e) ways to reports. There is no need for confidentiality. further reduce the information burden Frequency of Response: Monthly and Need and Uses: The Commission is for small business concerns with fewer annual reporting requirements and third submitting this expiring information than 25 employees. party disclosure requirements. collection to the Office of Management The FCC may not conduct or sponsor Obligation to Respond: Required to and Budget (OMB) as an extension (no a collection of information unless it obtain or retain benefits. Statutory change in the reporting and/or third displays a currently valid control authority for this collection of party disclosure requirement). This number. No person shall be subject to information is contained in 47 U.S.C. submission is being made to the OMB any penalty for failing to comply with sections 154, 201, 202, 203, 205, 218 in order to obtain the full three year a collection of information subject to the and 403. clearance. Paperwork Reduction Act (PRA) that Total Annual Burden: 11,250 hours. The Commission asked whether does not display a valid control number. Privacy Act Impact Assessment: N/A. physical collocation in remote terminals DATES: Persons wishing to comments on Nature and Extent of Confidentiality: presents technical or security concerns this information collection should There is no need for confidentiality. and, if so, whether these concerns submit comments on or before February Need and Uses: The Commission will warrant modification of its collocation 12, 2010. If you anticipate that you will submit this expiring information rules. The Commission asked whether be submitting comments, but find it collection to the Office of Management incumbent LECs should be required to difficult to do so within the period of and Budget (OMB) during this comment provide requesting carriers with time allowed by this notice, you should period in order to obtain the full three demographic and other information advise the contact listed below as soon year clearance from them. The regarding particular remote terminals as possible. Commission is submitting this similar to the information available ADDRESSES: Direct all PRA comments to collection as an extension (no change n regarding incumbent LEC central Nicholas A. Fraser, Office of the reporting and/or third party offices. Requesting carriers use Management and Budget (OMB), via fax disclosure requirements.) demographic and other information at (202) 395–5167, or via the Internet at Section 69.605 states that access obtained from incumbent LECs to [email protected] and revenues and cost data shall be reported determine whether they wish to to Judith B. Herman, Federal by participants in association tariffs to collocate at particular terminals. Communications Commission (FCC). To the association for computation of Federal Communications Commission. submit your PRA comments by e–mail monthly pool revenues distributions in send them to: [email protected]. accordance with this subpart. Marlene H. Dortch, To view a copy of this information The association shall submit a report Secretary, Office of the Secretary, Office of collection request (ICR) submitted to on or before February 1 of each calendar Managing Director. OMB: (1) Go to web page: http:// year describing the association’s cost [FR Doc. 2010–470 Filed 1–12–10; 8:45 am] www.reginfo.gov/public/do/PRAMain, study review process for the preceding BILLING CODE 6712–01–S (2) look for the section of the web page calendar year as well as the results of called ’’Currently Under Review’’, (3) that process. For any revisions to cost click on the downward–pointing arrow study results made or recommended by FEDERAL COMMUNICATIONS in the ’’Select Agency’’ box below the the association that would change the COMMISSION ’’Currently Under Review’’ heading, (4) respective carrier’s calculated annual Notice of Public Information Collection select ’’Federal Communications common line or traffic sensitive revenue Being Submitted for Review to the Commission’’ from the list of agencies requirement by ten percent or more, the Office of Management and Budget presented in the ’’Select Agency’’ box, report shall include the following (OMB), Comments Requested (5) click the ’’Submit’’ button to the right information: 1) the name of the carrier; of the ’’Select Agency’’ box, and (6) 2) a detailed description of the January 8, 2010. when the FCC list appears, look for the revisions; 3) the amount of the SUMMARY: The Federal Communications title of this ICR (or its OMB Control revisions; 4) the impact of the revisions Commission, as part of its continuing Number, if there is one) and then click on the carrier’s calculated common line effort to reduce paperwork burden on the ICR. and traffic sensitive revenue

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requirements; and 5) the carrier’s total members of the public will be subject to Audits conducted pursuant to 2 annual common line and traffic security screening procedures and must U.S.C. 437g, 438(b), and Title 26, U.S.C. sensitive revenue requirement. present valid photo identification to Matters concerning participation in The information is used to compute enter the building. The FDIC will civil actions or proceedings or charges in tariff for access service (or provide attendees with auxiliary aids arbitration. origination and termination) and to (e.g., sign language interpretation) Internal personnel rules and compute revenue pool distributions. required for this meeting. Those procedures or matters affecting a Neither process could be implemented attendees needing such assistance particular employee. without the information. should call (703) 562–6067 (Voice or PERSON TO CONTACT FOR INFORMATION: Federal Communications Commission. TTY) at least two days before the Judith Ingram, Press Officer, Telephone: Marlene H. Dortch, meeting to make necessary (202) 694–1220. arrangements. Written statements may Secretary, Office of the Secretary, Office of Darlene Harris, Managing Director. be filed with the committee before or after the meeting. Deputy Secretary of the Commission. [FR Doc. 2010–405 Filed 1–12–10; 8:45 am] This Community Banking Advisory [FR Doc. 2010–162 Filed 1–12–10; 8:45 am] BILLING CODE 6712–01–S Committee meeting will be Webcast live BILLING CODE 6715–01–M via the Internet at http://www.vodium. com/goto/fdic/communitybanking.asp. FEDERAL DEPOSIT INSURANCE This service is free and available to FEDERAL ELECTION COMMISSION CORPORATION anyone with the following systems requirements: http://www.vodium.com/ Sunshine Act Notices FDIC Advisory Committee on home/sysreq.html. Adobe Flash Player AGENCY: Federal Election Commission. Community Banking; Notice of Meeting is required to view these presentations. DATE AND TIME: The latest version of Adobe Flash Player Thursday, January 14, AGENCY: Federal Deposit Insurance 2010, at 10 a.m. Corporation (FDIC). can be downloaded at http://www. PLACE: 999 E Street, NW., Washington, ACTION: Notice of open meeting. adobe.com/shockwave/download/ download.cgi?P1_Prod_Version= DC (Ninth Floor). SUMMARY: In accordance with the ShockwaveFlash. Installation questions STATUS: This meeting will be open to the Federal Advisory Committee Act, notice or troubleshooting help can be found at public. is hereby given of a meeting of the FDIC the same link. For optimal viewing, a Items To Be Discussed Advisory Committee on Community high speed Internet connection is Banking, which will be held in recommended. The Community Banking CORRECTION AND APPROVAL OF MINUTES Washington, DC. The Advisory Advisory Committee meeting videos are DRAFT ADVISORY OPINION 2009–27: Committee will provide advice and made available on-demand American Future Fund Political Action recommendations on a broad range of approximately two weeks after the by its counsel, Jason Torchinsky. policy issues that have a particular event. For those unable to join the DRAFT ADVISORY OPINION 2009–29: Retiree impact on small community banks Webcast, this meeting is available Support Group of Contra Costa County throughout the United States and the through teleconference. Those audience by its counsel, L. Douglas Pipes. local communities they serve, with a members using this venue will be able focus on rural areas. to listen only. To access the Management and Administrative Matters DATES: January 28, 2010, from 8:30 a.m. teleconference, dial 1.888.917.8051, to 3:30 p.m. using the passcode FDIC. The Individuals who plan to attend and ADDRESSES: The meeting will be held in Community Banking Advisory require special assistance, such as sign the FDIC Board Room on the sixth floor Committee meeting videos are made language interpretation or other of the FDIC Building located at 550 17th available on-demand approximately two reasonable accommodations, should Street, NW., Washington, DC. weeks after the event. contact Darlene Harris, Deputy FOR FURTHER INFORMATION CONTACT: Dated: January 8, 2010. Commission Secretary, at (202) 694– Requests for further information Federal Deposit Insurance Corporation. 1040, at least 72 hours prior to the concerning the meeting may be directed Robert E. Feldman, hearing date. to Mr. Robert E. Feldman, Committee Committee Management Officer. PERSON TO CONTACT FOR INFORMATION: Judith Ingram, Press Officer, Telephone: Management Officer of the FDIC, at [FR Doc. 2010–465 Filed 1–12–10; 8:45 am] (202) 694–1220. (202) 898–7043. BILLING CODE 6714–01–P SUPPLEMENTARY INFORMATION: Darlene Harris, Agenda: The agenda will include a Deputy Secretary of the Commission. discussion of the impact of the current FEDERAL ELECTION COMMISSION [FR Doc. 2010–411 Filed 1–12–10; 8:45 am] environment on the ability of BILLING CODE 6715–01–M community banks to raise capital and Sunshine Act Notices increase lending, current examination AGENCY: Federal Election Commission. issues, regulatory reform and other FEDERAL RESERVE SYSTEM legislative proposals, as well as bank DATE AND TIME: Tuesday, January 12, 2010, at 10 a.m. resolution issues. The agenda is subject Formations of, Acquisitions by, and PLACE: 999 E Street, NW., Washington, to change. Any changes to the agenda Mergers of Bank Holding Companies will be announced at the beginning of DC. the meeting. STATUS: This meeting will be closed to The companies listed in this notice Type of Meeting: The meeting will be the public. have applied to the Board for approval, open to the public, limited only by the ITEMS TO BE DISCUSSED: pursuant to the Bank Holding Company space available on a first-come, first- Compliance matters pursuant to 2 Act of 1956 (12 U.S.C. 1841 et seq.) served basis. For security reasons, U.S.C. 437g. (BHC Act), Regulation Y (12 CFR Part

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225), and all other applicable statutes FEDERAL TRADE COMMISSION Because paper mail addressed to the and regulations to become a bank FTC is subject to delay due to [File No. 091 0068] holding company and/or to acquire the heightened security screening, please assets or the ownership of, control of, or Agrium Inc. and CF Industries Holding, consider submitting your comments in the power to vote shares of a bank or Inc.; Analysis of the Agreement electronic form. Comments filed in bank holding company and all of the Containing Consent Orders to Aid electronic form should be submitted by banks and nonbanking companies Public Comment using the following weblink (https:// owned by the bank holding company, public.commentworks.com/ftc/ AGENCY: including the companies listed below. Federal Trade Commission. agriumcf) and following the instructions ACTION: Proposed Consent Agreement. on the web-based form. To ensure that The applications listed below, as well the Commission considers an electronic as other related filings required by the SUMMARY: The consent agreement in this comment, you must file it on the web- Board, are available for immediate matter settles alleged violations of based form at the weblink: (https:// inspection at the Federal Reserve Bank federal law prohibiting unfair or public.commentworks.com/ftc/ indicated. The application also will be deceptive acts or practices or unfair agriumcf). If this Notice appears at available for inspection at the offices of methods of competition. The attached (http://www.regulations.gov/search/ the Board of Governors. Interested Analysis to Aid Public Comment index.jsp), you may also file an persons may express their views in describes both the allegations in the electronic comment through that writing on the standards enumerated in draft complaint and the terms of the website. The Commission will consider the BHC Act (12 U.S.C. 1842(c)). If the consent order — embodied in the all comments that regulations.gov proposal also involves the acquisition of consent agreement — that would settle forwards to it. You may also visit the a nonbanking company, the review also these allegations. FTC website at (http://www.ftc.gov/) to includes whether the acquisition of the DATES: Comments must be received on read the Notice and the news release nonbanking company complies with the or before January 22, 2010. describing it. standards in section 4 of the BHC Act ADDRESSES: Interested parties are A comment filed in paper form (12 U.S.C. 1843). Unless otherwise invited to submit written comments should include the ‘‘Agrium and CF noted, nonbanking activities will be electronically or in paper form. Industries, File No. 091 0068’’ reference conducted throughout the United States. Comments should refer to ‘‘Agrium and both in the text and on the envelope, Additional information on all bank CF Industries, File No. 091 0068’’ to and should be mailed or delivered to the following address: Federal Trade holding companies may be obtained facilitate the organization of comments. Commission, Office of the Secretary, from the National Information Center Please note that your comment — Room H-135 (Annex D), 600 website at www.ffiec.gov/nic/. including your name and your state — will be placed on the public record of Pennsylvania Avenue, NW, Washington, Unless otherwise noted, comments this proceeding, including on the DC 20580. The FTC is requesting that regarding each of these applications publicly accessible FTC website, at any comment filed in paper form be sent must be received at the Reserve Bank (http://www.ftc.gov/os/ by courier or overnight service, if indicated or the offices of the Board of publiccomments.shtm). possible, because U.S. postal mail in the Governors not later than February 5, Because comments will be made Washington area and at the Commission 2010. public, they should not include any is subject to delay due to heightened A. Federal Reserve Bank of San sensitive personal information, such as security precautions. The Federal Trade Commission Act Francisco (Tracy Basinger, Director, an individual’s Social Security Number; (‘‘FTC Act’’) and other laws the Regional and Community Bank Group) date of birth; driver’s license number or other state identification number, or Commission administers permit the 101 Market Street, San Francisco, collection of public comments to California 94105-1579: foreign country equivalent; passport number; financial account number; or consider and use in this proceeding as 1. BW Acquisition, LLC, and Teach credit or debit card number. Comments appropriate. The Commission will and Save, LLC (as a controlling owner also should not include any sensitive consider all timely and responsive of BW Acquisition, LLC), both of health information, such as medical public comments that it receives, Fountain Green, Utah, to become bank records or other individually whether filed in paper or electronic holding companies by acquiring 57.7 identifiable health information. In form. Comments received will be percent of the voting shares of Utah addition, comments should not include available to the public on the FTC Community Bancorp and thereby any ‘‘[t]rade secret or any commercial or website, to the extent practicable, at indirectly acquire Utah Community financial information which is obtained (http://www.ftc.gov/os/ Bank, both of Sandy, Utah. from any person and which is privileged publiccomments.shtm). As a matter of or confidential....,’’ as provided in discretion, the Commission makes every Section 6(f) of the FTC Act, 15 U.S.C. effort to remove home contact 46(f), and Commission Rule 4.10(a)(2), information for individuals from the Board of Governors of the Federal Reserve 16 CFR 4.10(a)(2). Comments containing public comments it receives before System, January 8, 2010. material for which confidential placing those comments on the FTC website. More information, including Robert deV. Frierson, treatment is requested must be filed in routine uses permitted by the Privacy Deputy Secretary of the Board. paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with Act, may be found in the FTC’s privacy [FR Doc. 2010–448 Filed 1–12–10; 8:45 am] FTC Rule 4.9(c), 16 CFR 4.9(c).1 policy, at (http://www.ftc.gov/ftc/ BILLING CODE 6210–01–S privacy.shtm). 1The comment must be accompanied by an explicit request for confidential treatment, The request will be granted or denied by the including the factual and legal basis for the request, Commission’s General Counsel, consistent with and must identify the specific portions of the applicable law and the public interest. See FTC comment to be withheld from the public record. Rule 4.9(c), 16 CFR 4.9(c).

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FOR FURTHER INFORMATION CONTACT: part of the public record. After thirty eliminate actual, direct, and substantial Robert S. Tovsky (202-326-2634), (30) days, the Commission will again competition between Agrium and CF in Bureau of Competition, 600 review the proposed Consent the relevant markets; increase Agrium’s Pennsylvania Avenue, NW, Washington, Agreement, and will decide whether it ability to exercise market power D.C. 20580. should withdraw from the proposed unilaterally in the relevant markets; and SUPPLEMENTARY INFORMATION: Pursuant Consent Agreement, modify it, or make substantially increase the level of to section 6(f) of the Federal Trade it final. concentration in the relevant markets and enhance the probability of Commission Act, 38 Stat. 721, 15 U.S.C. II. Description of the Parties and the coordination in the two markets in 46(f), and § 2.34 the Commission Rules Proposed Acquisition of Practice, 16 CFR 2.34, notice is Northern Illinois. hereby given that the above-captioned Agrium, a Calgary, Alberta-based AA is one of the three major forms of consent agreement containing a consent company, is a major supplier of nitrogen fertilizer with the other two order to cease and desist, having been agricultural products and services in being urea and urea ammonia nitrate filed with and accepted, subject to final North and South America. It is also a (‘‘UAN’’). Of the three nitrogen-based approval, by the Commission, has been leading global producer, distributor, and fertilizers, AA has the highest nitrogen placed on the public record for a period marketer of three primary groups of content at 82 percent, while urea and fertilizers: nitrogen, phosphate, and of thirty (30) days. The following UAN have 46 percent and 28 to 32 potash, as well as control release Analysis to Aid Public Comment percent nitrogen content, respectively. fertilizers and micronutrients. Agrium’s describes the terms of the consent AA also tends to be the least expensive operations in North America include agreement, and the allegations in the nitrogen fertilizer on a per pound of four nitrogen fertilizer manufacturing complaint. An electronic copy of the nitrogen basis. Thus, AA can often be plants and ten fertilizer storage and full text of the consent agreement the most cost effective means to deliver distribution terminals. Agrium’s total package can be obtained from the FTC nitrogen to the soil. net sales in 2008 were approximately When deciding which type of Home Page (for December 23, 2009), on $10 billion. nitrogen fertilizer to use, customers the World Wide Web, at (http:// CF Industries Holdings, Inc. is consider soil and topographical www.ftc.gov/os/actions.shtm). A paper headquartered in Deerfield, Illinois, and characteristics, equipment, and weather. copy can be obtained from the FTC is the holding company for CF AA is the most cost effective and Public Reference Room, Room 130-H, Industries, Inc., a major producer and efficient to use in dry areas where the 600 Pennsylvania Avenue, NW, distributor of nitrogen and phosphate topsoil is relatively thin. In moist Washington, D.C. 20580, either in fertilizers. CF owns two nitrogen conditions, there is a danger that AA person or by calling (202) 326-2222. fertilizer manufacturing plants and will leach into the water table, thus Public comments are invited, and may twenty-two fertilizer storage and becoming less effective, and that the be filed with the Commission in either distribution terminals in North America. heavy machinery required to apply AA paper or electronic form. All comments Its customers include cooperatives and would damage the field. should be filed as prescribed in the independent fertilizer retailers primarily AA is applied as a fertilizer directly ADDRESSES section above, and must be located in the eastern and western by injecting or ‘‘knifing’’ it into the soil. received on or before the date specified cornbelt states. CF’s total net sales in This process requires specialized in the DATES section. 2008 were approximately $3.9 billion. equipment to transport, store, and apply Analysis of Agreement Containing On February 25, 2009, Agrium the fertilizer. Customers who use AA Consent Order to Aid Public Comment publicly announced that it had have already made significant submitted a proposal to CF’s board of investments to acquire the necessary I. Introduction directors to acquire CF for a total infrastructure and application The Federal Trade Commission consideration of approximately $3.6 equipment. Switching away from AA (‘‘Commission’’ or ‘‘FTC’’) has accepted, billion. Since then, Agrium has thus would require customers to: (a) subject to final approval, an Agreement repeatedly extended its tender offer and abandon the investments they have Containing Consent Orders (‘‘Consent CF’s Board of Directors has consistently already made to use AA; and (b) make Agreement’’) from Agrium Inc. rejected these offers. Most recently, additional investments to obtain the (‘‘Agrium’’), that will completely remedy Agrium increased its offer to necessary infrastructure and application the anticompetitive effects that would approximately $4.95 billion. This offer equipment to apply other nitrogen likely result from Agrium’s proposed will expire on January 22, 2010. If CF products. These investments are costly acquisition of CF Industries Holdings, accepts Agrium’s tender offer, Agrium and switching from AA to one of the Inc. (‘‘CF’’). Under the terms of the will hold 100 percent of the voting other nitrogen-based fertilizers would be Consent Agreement, Agrium is required securities of CF, and CF will become a time-consuming. Thus, existing to, among other things, divest wholly owned subsidiary of Agrium. customers are not likely to shift away anhydrous ammonia (‘‘AA’’) terminals in from using AA. Ritzville, Washington, and Marseilles, III. The Proposed Complaint The proposed complaint alleges that Illinois to Terra Industries Inc. (‘‘Terra’’) The proposed complaint alleges that the three geographic areas in which to or another Commission-approved Agrium’s acquisition of CF, if analyze the competitive effects of the purchaser. Agrium is also required to consummated, may substantially lessen transaction are the PNW and two divest its rights to market and distribute competition or tend to create a adjacent areas in Northern Illinois. AA the AA produced by Rentech at monopoly in the distribution and sale of is transported from its site of production Rentech’s East Dubuque, Illinois AA in the Pacific Northwest (‘‘PNW’’) or from import terminals by barge, manufacturing plant back to Rentech. and two geographic areas in Northern pipeline, rail, and truck to fertilizer The proposed Consent Agreement has Illinois in violation of Section 7 of the storage terminals or, in limited been placed on the public record for Clayton Act, as amended, 15 U.S.C. § 18, situations, directly to fertilizer retailers. thirty (30) days for receipt of comments and Section 5 of the Federal Trade From there, AA is delivered by truck to by interested persons. Comments Commission Act, as amended, 15 U.S.C. local fertilizer retailers, where it is received during this period will become § 45. Specifically, the acquisition would stored in smaller scale storage tanks.

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The fertilizer retailers pump liquid AA Order also provides that Rentech will transition services to Terra or another from their storage tanks into smaller receive the rights to distribute and Commission-approved acquirer. The mobile nurse tanks. These nurse tanks market the AA produced in its own purpose of this provision is to allow for are then towed to a farmer’s field and manufacturing facility in East Dubuque. a smooth transition of the terminal hitched behind a tractor for application. Pursuant to a settlement agreement operations to the acquirer. Because fertilizer application seasons between Agrium and the Canadian Paragraph V of the proposed Decision are highly compressed, fertilizer Competition Bureau, Terra will acquire and Order requires that the Parties keep retailers expect a timely and reliable a 50 percent interest in Agrium’s private, except where necessary under source of AA supply to meet customer nitrogen fertilizer production plant in the agreement, confidential business demand during the peak of application Carseland, Alberta. The Carseland information related to the divested season. As transportation costs can divestiture will give Terra an terminals. Paragraph VI of the proposed make it difficult for terminal owners to unencumbered supply of AA for the Decision and Order provides for be price competitive and profitable, AA Ritzville, Washington terminal. appointment of a divestiture trustee. distributors must have adequate The Order to Hold Separate and Paragraph VII of the Decision and Order terminals or storage facilities within 100 Maintain Assets requires Agrium to provides mechanisms for the retention to 140 miles of customer locations. maintain the assets to be divested and of Ritzville Terminal and Marseilles In the PNW, Agrium and CF are the operate the Ritzville Terminal Terminal employees by the only major suppliers of AA. Thus, the independently until the respective Commission-approved acquirer. proposed acquisition would reduce the divestitures are completed. Paragraph VIII of the proposed number of significant AA suppliers in Decision and Order requires that the A. Key Provisions of the Decision and the PNW from 2 to 1. In the two areas Parties provide the Commission with Order in Northern Illinois, Agrium and CF are ‘‘advance written notification’’ of any two of only three significant suppliers of The proposed Decision and Order will intent to acquire assets or interests in AA. As a result, the proposed allow for effective divestiture of the key terminals that store AA in any area acquisition would reduce the number of assets that today allow CF to provide an affected by the proposed divestitures. major AA suppliers in those areas from independent competitive presence to Paragraphs IX-X define reporting three to two. Agrium in the relevant markets, and obligations. Paragraph XI requires As stated in the proposed complaint, therefore will preserve the market Agrium to provide the Commission entry would not be timely, likely, or structure. Paragraph II of the Decision access to company information and sufficient to deter or counteract the and Order provides that Agrium divest employees for purposes of determining anticompetitive effects of this the Ritzville Terminal and Carseland or securing compliance with the acquisition. A new entrant would need: Facility Interest to Terra within forty- Decision and Order. Paragraph XII states (1) sufficient AA storage capacity to five days of Agrium’s acquisition. This that the Decision and Order shall supply customers; (2) a proper paragraph further states that in the event terminate ten years after the date on distribution infrastructure; and (3) a that the Ritzville Terminal divestiture which the Order becomes final. secure source of AA for the storage cannot be made to Terra, Agrium will B. Key Provisions of the Order to Hold facility. For a new entrant to satisfy each have one-hundred-twenty days from the Separate and Maintain Assets of these steps requires significant sunk date the Decision and Order becomes costs, onerous regulatory approvals and final to divest these assets to a The Order to Hold Separate and local permitting, and technical Commission-approved acquirer that has Maintain Assets (‘‘Hold Separate Order’’) expertise. This does not take into a secure and stable, independent, long- requires that Agrium maintain the account the cost and time it takes to term source of AA. Marseilles Terminal, Ritzville Terminal, achieve a significant market impact. Paragraph III of the Decision and and Carseland Facility assets until such Thus, it is unlikely that new entry or Order provides that Agrium divest the time as the assets are divested. The Hold fringe expansion from another supplier Marseilles Terminal to Terra within Separate Order requires that Agrium would be timely, likely, or sufficient forty-five days of Agrium’s acquisition establish a system to maintain enough to thwart anticompetitive harm of CF. If this does not occur, the Order confidential information until the from the proposed acquisition. requires that Agrium divest the divestitures are completed. It also gives Marseilles Terminal to a Commission- the Commission the option to appoint a IV. The Terms of the Agreement approved acquirer within one-hundred- Monitor to ensure that Agrium complies Containing Consent Orders twenty days from the date the Decision with all of its obligations and performs The Consent Agreement will remedy and Order becomes final. Paragraph IV all of its responsibilities as required by the Commission’s competitive concerns requires Agrium to terminate its rights the Decision and Order and the Hold about the proposed acquisition and to distribute AA produced by Rentech Separate Order. The Hold Separate preserve competition in each of the pursuant to the Agrium/Rentech Order incorporates the traditional relevant markets. Under the terms of the Distribution Agreement no later than provisions that allow the Monitor broad Consent Agreement, Agrium would be five days after Agrium acquires CF. oversight of the assets, and requires the required to divest: (1) the CF Ritzville, The Decision and Order defines the Monitor to report to the Commission on Washington AA terminal; (2) its scope of the assets to include the a regular basis. The Hold Separate Order Marseilles, Illinois AA terminal; and (3) attributes of an ongoing business, such also requires Agrium to maintain the its rights to market the AA produced by as necessary real property, tangible Ritzville Terminal assets as an Rentech at Rentech’s East Dubuque, personal property, inventories, independent business pending Illinois, manufacturing plant. Agrium contracts, records of the business, divestiture. After the acquisition, the plans to divest the Ritzville and accounts receivable permits, and all Commission can require Agrium to Marseilles terminals to Terra, but the applicable regulatory registrations, appoint a Manager to run the terminal proposed Decision and Order provides permits, and applications. Pursuant to on an independent basis pending the for a divestiture to another purchaser Paragraphs II.G and III.G of the divestiture of the assets. Finally, the with a source of AA if Terra is unable proposed Decision and Order, Agrium Hold Separate Order allows the to accomplish the divestitures. The also is required to provide necessary Commission to appoint a Hold Separate

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Trustee to operate the assets if the assets information is necessary and whether it GENERAL SERVICES are not divested by the deadline set by will have practical utility; whether our ADMINISTRATION the Commission. estimate of the public burden of this The purpose of this analysis is to collection of information is accurate and [OMB Control No. 3090–0246] invite public comment on the proposed based on valid assumptions and General Services Administration Consent Agreement, in order to aid the methodology; and ways to enhance the Regulation; Submission for OMB Commission in its determination of quality, utility, and clarity of the Review; Packing List Clause whether to make the proposed Consent information to be collected. Agreement final. This analysis is not DATES: Submit comments on or before: AGENCY: Office of Acquisition Policy, intended to constitute an official February 12, 2010. GSA. interpretation of the proposed Consent FOR FURTHER INFORMATION CONTACT: ACTION: Notice of request for Agreement nor is it intended to modify Beverly Cromer, Procurement Analyst, reinstatement of and information the terms of the proposed Consent Acquisition Policy Division, at collection requirement for an existing Agreement in any way. telephone (202) 501–1448 or via e-mail OMB clearance. By direction of the Commission. to [email protected]. SUMMARY: Under the provisions of the ADDRESSES: Donald S. Clark, Submit comments regarding Paperwork Reduction Act of 1995 (44 Secretary. this burden estimate or any other aspect U.S.C. Chapter 35), the General Services of this collection of information, [FR Doc. 2010–410 Filed 1–12–10; 8:45 am] Administration will be submitting to the including suggestions for reducing this BILLING CODE 6750–01–S Office of Management and Budget burden to the Regulatory Secretariat (OMB) a request to review and approve (MVPR), General Services a reinstatement of a previously Administration, 1800 F Street, NW., GENERAL SERVICES approved information collection Room 4041, Washington, DC 20405. ADMINISTRATION requirement regarding the packing list Please cite OMB Control No. 3090–0086, clause. A request for public comments [OMB Control No. 3090–0086] GSA Form 1364/1364A, Proposal to was published in the Federal Register at Lease Space (Not Required by 74 FR 52811, October 14, 2009. No General Services Administration Regulation), in all correspondence. comments were received. Acquisition Regulation; Submission SUPPLEMENTARY INFORMATION: for OMB Review; GSA Form 1364, Public comments are particularly Proposal To Lease Space A. Purpose invited on: whether this collection of information is necessary and whether it The General Services Administration AGENCY: Acquisition Policy Division, will have practical utility; whether our (GSA) has various mission GSA. estimate of the public burden of this responsibilities related to the ACTION: Notice of request for comments collection of information is accurate, acquisition and provision of real regarding a reinstatement of an and based on valid assumptions and property management, and disposal of information collection requirement for methodology; and ways to enhance the real and personal property. These an existing OMB clearance. quality, utility, and clarity of the mission responsibilities generate information to be collected. SUMMARY: Under the provisions of the requirements that are realized through DATES: Submit comments on or before: Paperwork Reduction Act of 1995 (44 the solicitation and award of leasing February 12, 2010. U.S.C. Chapter 35), the General Services contracts. Individual solicitations and Administration will be submitting to the resulting contracts may impose unique ADDRESSES: Submit comments regarding Office of Management and Budget information collection/reporting this burden estimate or any other aspect (OMB) a request to review and approve requirements on contractors, not of this collection of information, a revision to the reinstatement of a required by regulation, but necessary to including suggestions for reducing this previously approved information evaluate particular program burden to the GSA Desk Officer, OMB, collection requirement regarding GSA accomplishments and measure success Room 10236, NEOB, Washington, DC Forms 1364/1364A, Proposal to Lease in meeting program objectives. 20503, and a copy to the Regulatory Secretariat (MVPR), General Services Space (Not Required by Regulation). B. Annual Reporting Burden This form is used to obtain information Administration, 1800 F Street, NW., about property being offered for lease to Respondents: 5733. Room 4041, Washington, DC 20405. Responses Per Respondent: 1. house Federal agencies. In the past, GSA Please cite OMB Control No. 3090–0246, Hours Per Response: 5.0205. also used a 1364A which requested Packing List Clause, in all Total Burden Hours: 28,783. correspondence. information regarding how tenant Obtaining Copies of Proposals: improvements were financed by a Requesters may obtain a copy of the FOR FURTHER INFORMATION CONTACT: prospective lessor. The new version of information collection documents from Michael O. Jackson, Procurement form combines the former 1364 and the General Services Administration, Analyst, Contract Policy Branch, by 1364A, and it also collects other Regulatory Secretariat (MVPR), 1800 F telephone (202) 208–4949 or via e-mail financial aspects contained in an offer Street, NW., Room 4041, Washington, at [email protected]. for analysis and negotiation into lease DC 20405, telephone (202) 501–4755. SUPPLEMENTARY INFORMATION: contracts (e.g. real estate taxes, Please cite OMB Control No. 3090–0086, A. Purpose adjustments for vacant space, offerors’ GSA Form 1364, Proposal to Lease design and construction fees). A request Space, in all correspondence. GSAR clause 552.211–77, Packing for public comments was published in List, requires a contractor to include a the Federal Register at 74 FR 52811, on Dated: January 7, 2010. packing list that verifies placement of an October 14, 2009. No comments were Al Matera, order and identifies the items shipped. received. Director, Acquisition Policy Division. In addition to information contractors Public comments are particularly [FR Doc. 2010–417 Filed 1–12–10; 8:45 am] would normally include on packing invited on: Whether this collection of BILLING CODE 6820–61–P lists, the identification of cardholder

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name, telephone number and the term proposed data collection projects, the comprehensive Exam 3 that began in ‘‘Credit Card’’ is required. National Heart, Lung, and Blood February 2009. The two new exams Institute (NHLBI), the National include some repeated measures from B. Annual Reporting Burden Institutes of Health (NIH) will publish Exam 1 and several new components, Respondents: 4,000. periodic summaries of proposed including distribution of self-monitoring Responses per Respondent: 233. projects to be submitted to the Office of blood pressure devices. The Hours per Response: .00833. Management and Budget (OMB) for continuation of the study allows Total Burden Hours: 7757. review and approval. continued assessment of subclinical Obtaining Copies of Proposals: Proposed Collection: Title: The coronary disease, left ventricular Requesters may obtain a copy of the Jackson Heart Study: Annual Follow-up dysfunction, progression of carotid information collection documents from with Third Party Respondents. Type of atherosclerosis and left ventricular the General Services Administration, Information Collection Request: hypertrophy, and responses to stress, Regulatory Secretariat (MVPR), 1800 F Revision of a currently approved racism, and discrimination as well as Street, NW., Room 4041, Washington, collection (OMB NO. 0925–0491). Need new components such as renal disease, DC 20405, telephone (202) 501–4755. and Use of Information Collection: This body fat distribution and body Please cite OMB Control No. 3090–0246, project involves contacting next-of-kin composition, and metabolic Packing List Clause, in all and family physicians of deceased consequences of obesity. correspondence. participants who were part of the Frequency of Response: One-time. Dated: January 7, 2010. Jackson Heart Study exam. Interviewers Affected Public: Individuals or Al Matera, will contact doctors and hospitals to ascertain participants’ cardiovascular households; Businesses or other for Director, Acquisition Policy Division. events. Information gathered will be profit; not-for-profit institutions. Type of [FR Doc. 2010–418 Filed 1–12–10; 8:45 am] used to further describe the risk factors, Respondents: Adults; doctors and staff BILLING CODE 6820–61–P occurrence rates, and consequences of of hospitals and nursing homes. The cardiovascular disease in African annual reporting burden is as follows: American men and women. Recruitment Estimated Number of Respondents: 400; DEPARTMENT OF HEALTH AND of 5,500 JHS participants began in Estimated Number of Responses per HUMAN SERVICES September 2000 and was completed in Respondent: 1.0; Average Burden Hours March 2004. 5,302 participants per Response: (84 hours/400 National Institutes of Health completed a baseline Exam 1 that respondents) 0.21; and Estimated Total Annual Burden Hours Requested: 84. Proposed Collection; Comment included demographics, psychosocial The annualized cost to respondents is Request; The Jackson Heart Study inventories, medical history, (JHS) anthropometry, resting and ambulatory estimated at $3,760, assuming $15 per blood pressure, phlebotomy and 24- burden hour for informants and $65 per Summary: In compliance with the hour urine collection, ECG, burden hour for physicians. There are requirement of Section 3506(c)(2)(A) of echocardiography, and pulmonary no Capital Costs to report. There are no the Paperwork Reduction Act of 1995, function. JHS Exam 2 began September Operating or Maintenance Costs to for opportunity for public comment on 26 2005, followed by a more report.

ESTIMATE OF ANNUAL HOUR BURDEN

Number of Frequency of Average time Annual hour Type of response respondents response per response burden

Morbidity & Mortality AFU 3rd Party/Next-of-kin decedents ...... 200 1 0.17 34 Morbidity & Mortality AFU 3rd Party Physicians ...... 200 1 0.25 50

Total ...... 400 ...... 84

Request for Comments: Written appropriate automated, electronic, received within 60 days of the date of comments and/or suggestions from the mechanical, or other technological this publication. public and affected agencies are invited collection techniques or other forms of Suzanne Freeman, on one or more of the following points: information technology. (1) Whether the proposed collection of NHLBI Project Clearance Liaison, National FOR FURTHER INFORMATION CONTACT: To information is necessary for the proper Institutes of Health. performance of the function of the request more information on the Michael Lauer, agency, including whether the proposed project or to obtain a copy of Director, DCVS, National Institutes of Health. the data collection plans and information will have practical utility; [FR Doc. 2010–419 Filed 1–12–10; 8:45 am] instruments, contact Ms. Cheryl Nelson, (2) The accuracy of the agency’s BILLING CODE 4140–01–P estimate of the burden of the proposed Project Officer, NIH, NHLBI, 6701 collection of information, including the Rockledge Drive, MSC 7934, Bethesda, validity of the methodology and MD 20892–7934, or call non-toll-free assumptions used; (3) Ways to enhance number 301–435–0451 or E-mail your the quality, utility, and clarity of the request, including your address to: information to be collected; and (4) [email protected]. Ways to minimize the burden of the Comments Due Date: Comments collection of information on those who regarding this information collection are are to respond, including the use of best assured of having their full effect if

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DEPARTMENT OF HEALTH AND clarity of the information to be States and the Federal government. This HUMAN SERVICES collected; and (d) ways to minimize the data collection, authorized by 42 U.S.C. burden of the collection of information 242k, has been carried out by NCHS Centers for Disease Control and on respondents, including through the since it was created in 1960. Prevention use of automated collection techniques NCHS assists in achieving the or other forms of information comparability needed for combining [60Day–10–0217] technology. Written comments should data from all States into national Proposed Data Collections Submitted be received within 60 days of this statistics, by conducting a training for Public Comment and notice. program for State and local vital statistics staff to assist in developing Recommendations Proposed Project expertise in all aspects of vital In compliance with the requirement Vital Statistics Training Application, registration and vital statistics. The of Section 3506(c)(2)(A) of the (OMB No. 0920–0217 exp. 7/31/2010)— training offered under this program Paperwork Reduction Act of 1995 for Extension—National Center for Health includes courses for registration staff, opportunity for public comment on Statistics (NCHS), Centers for Disease statisticians, and coding specialists, all proposed data collection projects, the Control and Prevention (CDC). designed to bring about a high degree of Centers for Disease Control and uniformity and quality in the data Background and Brief Description Prevention (CDC) will publish periodic provided by the States. This training summaries of proposed projects. To In the United States, legal authority program is authorized by 42 U.S.C. request more information on the for the registration of vital events, i.e., 242b, section 304(a). In order to offer the proposed projects or to obtain a copy of births, deaths, marriages, divorces, fetal types of training that would be most the data collection plans and deaths, and induced terminations of useful to vital registration staff instruments, call 404–639–5960 and pregnancy, resides individually with the members, NCHS requests information send comments to Maryam I. Daneshvar, States (as well as cities in the case of from State and local vital registration CDC Acting Reports Clearance Officer, New York City and Washington, DC) officials about their projected needs for 1600 Clifton Road, MS–D74, Atlanta, and Puerto Rico, the Virgin Islands, training. NCHS also asks individual GA 30333 or send an e-mail to Guam, American Samoa, and the candidates for training to submit an [email protected]. Commonwealth of the Northern Mariana application form containing name, Comments are invited on: (a) Whether Islands. These governmental entities are address, occupation, work experience, the proposed collection of information the full legal proprietors of vital records education, and previous training. These is necessary for the proper performance and the information contained therein. data enable NCHS to determine those of the functions of the agency, including As a result of this State authority, the individuals whose needs can best be whether the information shall have collection of registration-based vital met through the available training practical utility; (b) the accuracy of the statistics at the national level, referred resources. NCHS is requesting 3 years of agency’s estimate of the burden of the to as the U.S. National Vital Statistics OMB clearance for this project. proposed collection of information; (c) System (NVSS), depends on a There is no cost to respondents in ways to enhance the quality, utility, and cooperative relationship between the providing these data.

ESTIMATED ANNUALIZED BURDEN HOURS

Average Number of Number of burden per Total burden Respondents respondents responses per response hours respondent (in hours)

State, local, and Territory Registration Officials ...... 57 1 20/60 19 Training applicants ...... 100 1 15/60 25

Total ...... 44

Dated: January 7, 2010. DEPARTMENT OF HEALTH AND ‘‘Guidance for IRBs, Clinical Maryam I. Daneshvar, HUMAN SERVICES Investigators, and Sponsors: IRB Acting Reports Clearance Officer, Centers for Continuing Review After Clinical Disease Control and Prevention. Food and Drug Administration Investigation Approval.’’ The draft [FR Doc. 2010–510 Filed 1–12–10; 8:45 am] [Docket No. FDA–2009–D–0605] guidance announced in this notice is BILLING CODE 4163–18–P intended to assist institutional review Draft Guidance for Institutional Review boards (IRBs) in carrying out their Boards, Clinical Investigators, and continuing review responsibility by Sponsors: IRB Continuing Review providing recommendations regarding After Clinical Investigation Approval; the criteria, process, and frequency of Availability continuing review to assure the AGENCY: Food and Drug Administration, protection of the rights and welfare of HHS. subjects in clinical investigations. The ACTION: Notice. draft guidance should also help clinical investigators and sponsors better SUMMARY: The Food and Drug understand their responsibilities related Administration (FDA) is announcing the to continuing review. availability of a draft guidance entitled,

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DATES: Although comments on any and sponsors better understand their II. The Paperwork Reduction Act of guidance can be submitted at any time responsibilities related to continuing 1995 (see 21 CFR 10.115(g)(5)), to ensure that review. When finalized, this guidance the agency considers a comment on this will supersede the Information Sheet, This draft guidance includes draft guidance before it begins work on ‘‘Continuing Review After Study information collection provisions that the final version of the guidance, Approval’’ (September 1998, Office of are subject to review by the Office of written or electronic comments on the Health Affairs, Food and Drug Management and Budget (OMB) under draft guidance should be submitted by Administration). the Paperwork Reduction Act (PRA) of March 15, 2010. Submit written To enhance human subject protection 1995 (44 U.S.C. 3501–3520) (PRA). The comments on the draft guidance to the and reduce regulatory burden, the collections of information referenced in Division of Dockets Management (HFA– Department of Health and Human this guidance that are related to IRB 305), Food and Drug Administration, Services, Office for Human Research recordkeeping requirements under 21 5630 Fishers Lane, rm. 1061, Rockville, Protections (OHRP) and FDA have been CFR 56.115, which include the MD 20852. Submit electronic comments actively working to harmonize the requirements for records of continuing to http://www.regulations.gov. See the agencies’ regulatory requirements and review, have been approved under OMB SUPPLEMENTARY INFORMATION section for guidance for human subject research. Control No. 0910–0130; the collections electronic access to the draft guidance This draft guidance document was of information in part 312 (21 CFR part document. developed as part of these efforts. 312) have been approved under OMB ADDRESSES: Submit written requests for FDA is issuing this as a draft guidance control number 0910–0014; and the single copies of this draft guidance to because it has been substantially revised collections of information in part 812 the Division of Drug Information, Center in response to numerous questions (21 CFR part 812) have been approved for Drug Evaluation and Research about the continuing review process under OMB control number 0910–0078. (CDER), Food and Drug Administration, from the IRB and research communities. In accordance with the PRA, prior to 10903 New Hampshire Ave., White Oak Changes include more detailed publication of any final guidance (WO) Bldg. 51, rm. 2201, Silver Spring, discussion about what should be document, FDA intends to solicit public MD 20993–0002 (1–888–463–6332 or submitted to assist the IRB in comment, and obtain OMB approval for 301–796–3400); or the Office of conducting continuing review, Communication, Outreach and discussion of the circumstances in any information collections Development (HFM–40), Center for which expedited review procedures recommended in this guidance that are Biologics Evaluation and Research may be used for continuing review, and new or that would represent material (CBER), Food and Drug Administration, guidance about how continuing review modifications to these previously 1401 Rockville Pike, suite 200N, dates should be determined. approved collections of information Rockville, MD 20852–1448 (1–800–835– This draft guidance is part of the found in FDA regulations. 4709 or 301–827–1800); or the Division Information Sheet Guidance Initiative, III. Comments of Small Manufacturers, International, announced in the Federal Register of and Consumer Assistance, Center for February 3, 2006 (71 FR 5861), which Interested persons may submit to the Devices and Radiological Health describes FDA’s intention to update the Division of Dockets Management (see (CDRH), Food and Drug Administration, process for developing, issuing, and ADDRESSES) written or electronic 10903 New Hampshire Ave. (WO Bldg. making available guidances intended for comments regarding this draft guidance. 66, rm. 4622), Silver Spring, MD 20993 IRBs, clinical investigators, and Submit a single copy of electronic (1–800–638–2041 or 301–796–7100). sponsors. Known as ‘‘Information comments or two paper copies of any Send one self-addressed adhesive label Sheets,’’ these guidances have provided mailed comments, except that to assist the office in processing your recommendations to IRBs, clinical individuals may submit one paper copy. requests. investigators, and sponsors to help them Comments are to be identified with the FOR FURTHER INFORMATION CONTACT: Sara fulfill their responsibilities to protect docket number found in brackets in the Goldkind, Office of Good Clinical human subjects who participate in heading of this document. Received research regulated by the FDA. The Practice (HF–34), Food and Drug comments may be seen in the Division Information Sheet Guidance Initiative is Administration, 5600 Fishers Lane, rm. of Dockets Management between 9 a.m. intended to ensure that the Information 16–85, Rockville, MD 20857, 301–827– and 4 p.m., Monday through Friday. 3340. Sheets are updated, consistent with the SUPPLEMENTARY INFORMATION: FDA’s good guidance practices (GGPs). IV. Electronic Access As part of the initiative, which will be I. Background ongoing, the agency plans to rescind Persons with access to the Internet FDA is announcing the availability of Information Sheets that are obsolete, may obtain the document at http:// a draft guidance entitled, ‘‘Guidance for revise and reissue guidances that www.regulations.gov, or http:// IRBs, Clinical Investigators, and address current issues, and develop new www.fda.gov/ScienceResearch/ Sponsors: IRB Continuing Review After guidance documents as needed. SpecialTopics/RunningClinicalTrials/ Clinical Investigation Approval.’’ This The draft guidance is being issued ProposedRegulationsand guidance is intended to assist IRBs in consistent with FDA’s GGPs regulation DraftGuidances/default.htm carrying out their continuing review (21 CFR 10.115). The draft guidance, Dated: January 7, 2010. responsibility under 21 CFR 56.108(a) when finalized, will represent FDA’s and 56.109(f) by providing current thinking on this topic. It does David Dorsey, recommendations regarding the criteria, not create or confer any rights for or on Acting Deputy Commissioner for Policy, process, and frequency of continuing any person and does not operate to bind Planning and Budget. review to assure the protection of the FDA or the public. An alternative [FR Doc. 2010–426 Filed 1–12–10; 8:45 am] rights and welfare of subjects in clinical approach may be used if such approach BILLING CODE 4160–01–S investigations. The draft guidance satisfies the requirements of the should also help clinical investigators applicable statutes and regulations.

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DEPARTMENT OF HEALTH AND Georgetown University will enable the Dated: January 6, 2010. HUMAN SERVICES MCH Library to continue to provide this Jennifer Spaeth, important service to MCH professionals Director, Office of Federal Advisory Health Resources and Services and members of the public without Committee Policy. Administration disruption or delays until the results of [FR Doc. 2010–421 Filed 1–12–10; 8:45 am] the competition are known and a new BILLING CODE 4140–01–P Maternal and Child Health Bureau award can be issued. AGENCY: Health Resources and Services FOR FURTHER INFORMATION CONTACT: Administration (HRSA), HHS. James A. Resnick, Public Health DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Notice of Non-competitive Analyst, Office of Data and Program Development, Maternal and Child Supplemental Funding to Georgetown National Institutes of Health University. Health Bureau, Health Resources and Services Administration, 5600 Fishers Center for Scientific Review; Notice of SUMMARY: The Health Resources and Lane, Rockville, MD 20857; phone 301– Closed Meetings Services Administration (HRSA) is 443–3222; e-mail: [email protected]. issuing non-competitive supplemental Dated: January 8, 2010. Pursuant to section 10(d) of the funding under the Maternal Child Mary K. Wakefield, Federal Advisory Committee Act, as Health Bureau, Title V program to Administrator. amended (5 U.S.C. App.), notice is ensure that Georgetown University, hereby given of the following meetings. Maternal and Child Health Library can [FR Doc. 2010–476 Filed 1–12–10; 8:45 am] BILLING CODE 4165–15–P The meetings will be closed to the continue to provide much needed public in accordance with the services to MCH professionals and provisions set forth in sections members of the public. DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., SUPPLEMENTARY INFORMATION: HUMAN SERVICES as amended. The grant applications and Intended Recipient of the Award: the discussions could disclose Georgetown University. National Institutes of Health confidential trade secrets or commercial Amount of the Non-Competitive property such as patentable material, Supplemental Funding: $137,500. National Institute of Arthritis and and personal information concerning Project Period: The original project Musculoskeletal and Skin Diseases; individuals associated with the grant period for this grant is from January 1, Notice of Closed Meeting applications, the disclosure of which 2005 through December 31, 2009. Pursuant to section 10(d) of the would constitute a clearly unwarranted Period of Supplemental Support: Federal Advisory Committee Act, as invasion of personal privacy. January 1, 2010 through March 31, 2010. amended (5 U.S.C. App.), notice is Name of Committee: Center for Scientific Authority: This activity is under the hereby given of the following meeting. Review Special Emphasis Panel; Member authority of Title V, Section 501(a)2 of the The meeting will be closed to the Conflict: Tumor Immunology and Social Security Act as amended, 42 U.S.C. public in accordance with the Immunotherapy. 701. provisions set forth in sections Date: January 12, 2010. Catalogue of Federal Domestic Time: 2 p.m. to 5 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Assistance Number: 93.110. Agenda: To review and evaluate grant as amended. The grant applications and applications. Justification for Non-Competitive the discussions could disclose Place: National Institutes of Health, 6701 Supplemental Funding confidential trade secrets or commercial Rockledge Drive, Bethesda, MD 20892 The Maternal and Child Health (MCH) property such as patentable material, (Telephone Conference Call). Contact Person: Lambratu Rahman, PhD, Library at Georgetown University serves and personal information concerning individuals associated with the grant Scientific Review Officer, Center for as a national information and education Scientific Review, National Institutes of resource library to help meet the applications, the disclosure of which would constitute a clearly unwarranted Health, 6701 Rockledge Drive, Room 6214, changing needs of professionals, MSC 7804, Bethesda, MD 20892, 301–451– families with children, and the general invasion of personal privacy. 3493, [email protected]. public in the field of maternal and child Name of Committee: National Institute of This notice is being published less than 15 health. The overall goal is to use Arthritis and Musculoskeletal and Skin days prior to the meeting due to the timing information science and information Diseases Special Emphasis Panel, Small limitations imposed by the review and technology to identify, collect, and Research Grants Review. funding cycle. Date: February 4, 2010. Name of Committee: Center for Scientific organize information from the MCH Time: 10 a.m. to 4 p.m. field that is not readily available from Review Special Emphasis Panel, Member Agenda: To review and evaluate grant Conflict: AARR. other information sources and to make applications. Date: January 14, 2010. the information available for application Place: National Institutes of Health, 6701 Time: 11 a.m. to 2 p.m. by the MCH community in a timely, Rockledge Drive, Bethesda, MD 20892 Agenda: To review and evaluate grant easy-to-access manner. (Virtual Meeting). applications. Due to an unanticipated delay in the Contact Person: Michael L. Bloom, PhD, Place: National Institutes of Health, 6701 issuance of the funding opportunity MBA, Scientific Review Officer, National Rockledge Drive, Bethesda, MD 20892 announcement for this grant program, Institute of Arthritis, Musculoskeletal and (Telephone Conference Call). Skin Diseases, National Institutes of Health, Contact Person: Robert Freund, PhD, the award of non-competitive funding 6701 Democracy Blvd; Room 820, MSC 4872, for the period January 1, 2010, to March Scientific Review Officer, Center for Bethesda, MD 20892–4872, 301–594–4953, Scientific Review, National Institutes of _ 31, 2010, to Georgetown University is Michael [email protected]. Health, 6701 Rockledge Drive, Room 3200, necessary. In early fiscal year 2010, an (Catalogue of Federal Domestic Assistance MSC 7848, Bethesda, MD 20892, 301–435– open competition will take place for this Program Nos. 93.846, Arthritis, 1050, [email protected]. grant program. The award of non- Musculoskeletal and Skin Diseases Research, This notice is being published less than 15 competitive supplemental funding for National Institutes of Health, HHS) days prior to the meeting due to the timing

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limitations imposed by the review and Health, 6701 Rockledge Drive, Room 5170, Place: InterContinental Mark Hopkins funding cycle. MSC 7840, Bethesda, MD 20892, 301–435– Hotel, One Nob Hill, San Francisco, CA (Catalogue of Federal Domestic Assistance 2406, [email protected]. 94108. Program Nos. 93.306, Comparative Medicine; Name of Committee: Risk, Prevention and Contact: Suzan Nadi, PhD, Scientific 93.333, Clinical Research, 93.306, 93.333, Health Behavior Integrated Review Group; Review Officer, Center for Scientific Review, 93.337, 93.393–93.396, 93.837–93.844, Social Psychology, Personality and National Institutes of Health, 6701 Rockledge 93.846–93.878, 93.892, 93.893, National Interpersonal Processes Study Section. Drive, Room 5217B, MSC 7846, Bethesda, Institutes of Health, HHS) Date: February 4–5, 2010. MD 20892, 301–435–1259, Time: 8 a.m. to 5 p.m. [email protected]. Dated: January 6, 2010. Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance Jennifer Spaeth, applications. Program Nos. 93.306, Comparative Medicine; Director, Office of Federal Advisory Place: Hyatt Regency Bethesda, One 93.333, Clinical Research, 93.306, 93.333, Committee Policy. Bethesda Metro Center, 7400 Wisconsin 93.337, 93.393–93.396, 93.837–93.844, [FR Doc. 2010–423 Filed 1–12–10; 8:45 am] Avenue, Bethesda, MD 20814. 93.846–93.878, 93.892, 93.893, National BILLING CODE 4140–01–P Contact: Michael Micklin, PhD, Scientific Institutes of Health, HHS) Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dated: January 6, 2010. Jennifer Spaeth, DEPARTMENT OF HEALTH AND Drive, Room 3136, MSC 7759, Bethesda, MD 20892, (301) 435–1258, HUMAN SERVICES Director, Office of Federal Advisory [email protected]. Committee Policy. National Institutes of Health Name of Committee: Biological Chemistry [FR Doc. 2010–425 Filed 1–12–10; 8:45 am] and Macromolecular Biophysics Integrated BILLING CODE 4140–01–P Center for Scientific Review; Notice of Review Group; Macromolecular Structure and Function B Study Section. Closed Meetings Date: February 4–5, 2010. DEPARTMENT OF HEALTH AND Time: 8 a.m. to 12 p.m. Pursuant to section 10(d) of the HUMAN SERVICES Federal Advisory Committee Act, as Agenda: To review and evaluate grant applications. amended (5 U.S.C. App.), notice is Place: The Westin St. Francis, 335 Powell Centers for Disease Control and hereby given of the following meetings. Street, San Francisco, CA 94102. Prevention The meetings will be closed to the Contact: Arnold Revzin, PhD, Scientific public in accordance with the Review Officer, Center for Scientific Review, Study Team for the Los Alamos provisions set forth in sections National Institutes of Health, 6701 Rockledge Historical Document Retrieval and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Drive, Room 4146, MSC 7824, Bethesda, MD Assessment (LAHDRA) Project as amended. The grant applications and 20892, (301) 435–1153, [email protected]. The Centers for Disease Control and the discussions could disclose Name of Committee: Center for Scientific confidential trade secrets or commercial Review Special Emphasis Panel; Member Prevention (CDC) and the Agency for property such as patentable material, Conflict: EPIC Members (b) Special Emphasis Toxic Substances and Disease Registry and personal information concerning Panel. (ATSDR) announces the following individuals associated with the grant Date: February 9, 2010. meeting. Time: 11:30 a.m. to 5 p.m. Name: Public Meeting of the Study Team applications, the disclosure of which Agenda: To review and evaluate grant for the Los Alamos Historical Document would constitute a clearly unwarranted applications. Retrieval and Assessment Project. invasion of personal privacy. Place: National Institutes of Health, 6701 Time and Date: 9 a.m.–4 p.m., (Mountain Rockledge Drive, Bethesda, MD 20892 Name of Committee: Center for Scientific Time), Thursday, January 28, 2010. (Virtual Meeting). Review Special Emphasis Panel; NHLBI Place: OHKAY Casino/Resort/Conference Contact: Bob Weller, PhD, Scientific Systems Biology. Center (2 miles north of Espanola on US 84/ Review Officer, Center for Scientific Review, Date: January 20, 2010. 285), P.O. Box 1270, Highway 68 Espanola, National Institutes of Health, 6701 Rockledge Time: 8 a.m. to 6 p.m. New Mexico 87506, telephone (505) 747– Drive, Room 3160, MSC 7770, Bethesda, MD Agenda: To review and evaluate grant 5523, facsimile (877) 747–5695. See 20892, (301) 435–0694, [email protected]. applications. following url/link for area map: http:// Place: The Fairmont Washington, DC, 2401 Name of Committee: Biological Chemistry www.ohkay.com/contactus.html. M Street, NW., Washington, DC 20037. and Macromolecular Biophysics Integrated Status: Open to the public, limited only by Contact Person: Ai-Ping Zou, MD, PhD, Review Group; Macromolecular Structure the space available. The meeting room Scientific Review Officer, Center for and Function A Study Section. accommodates approximately 200 people. Scientific Review, National Institutes of Date: February 11, 2010. Background: Under a Memorandum of Health, 6701 Rockledge Drive, Room 4118, Time: 8 a.m. to 5 p.m. Understanding (MOU) signed in December MSC 7814, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant 1990 with the Department of Energy (DOE) 1777, [email protected]. applications. and replaced by MOUs signed in 1996 and This notice is being published less than 15 Place: George Washington University Inn, 2000, the Department of Health and Human days prior to the meeting due to the timing 824 New Hampshire Avenue, NW., Services (HHS) was given the responsibility limitations imposed by the review and Washington, DC 20037. and resources for conducting analytic funding cycle. Contact: David R. Jollie, PhD, Scientific epidemiologic investigations of residents of Name of Committee: Center for Scientific Review Officer, Center for Scientific Review, communities in the vicinity of DOE facilities, Review Special Emphasis Panel; Cancer National Institutes of Health, 6701 Rockledge workers at DOE facilities, and other persons Biomarker Genomics/Proteomics. Drive, Room 4150, MSC 7806, Bethesda, MD potentially exposed to radiation or to Date: February 3, 2010. 20892, (301) 435–1722, [email protected]. potential hazards from non-nuclear energy Time: 8 a.m. to 5 p.m. Name of Committee: Brain Disorders and production use. HHS delegated program Agenda: To review and evaluate grant Clinical Neuroscience Integrated Review responsibility to CDC and ATSDR. applications. Group; Clinical Neuroplasticity and In addition, a memo was signed in October Place: Hilton Alexandria Old Town, 1767 Neurotransmitters Study Section. 1990 and renewed in November 1992, 1996, King Street, Alexandria, VA 22314. Date: February 11–12, 2010. and in 2000, between the Agency for Toxic Contact Person: Jonathan Arias, PhD, Time: 8 a.m. to 5 p.m. Substances and Disease Registry (ATSDR) Scientific Review Officer, Center for Agenda: To review and evaluate grant and DOE. The MOU delineates the Scientific Review, National Institutes of applications. responsibilities and procedures for ATSDR’s

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public health activities at DOE sites required provisions set forth in sections Name of Committee: National Institute of under sections 104, 105, 107, and 120 of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Nursing Research Initial Review Group. Comprehensive Environmental Response, as amended. The contract proposals and Date: February 18–19, 2010. Compensation, and Liability Act (CERCLA or the discussions could disclose Time: 8 a.m. to 12 p.m. a Superfund). These activities include health Agenda: To review and evaluate grant consultations and public health assessments confidential trade secrets or commercial applications. at DOE sites listed on, or proposed for, the property such as patentable material, Place: Bethesda Marriott Suites, 6711 Superfund National Priorities List and at and personal information concerning Democracy Boulevard, Bethesda, MD 20817. sites that are the subject of petitions from the individuals associated with the contract Contact Person: Weiqun Li, MD, Scientific public; and other health-related activities proposals, the disclosure of which Review Officer, National Institute of Nursing such as epidemiologic studies, health would constitute a clearly unwarranted Research, National Institutes of Health, 6701 surveillance, exposure and disease registries, invasion of personal privacy. Democracy Blvd., Ste. 710, Bethesda, MD health education, substance-specific applied 20892, (301) 594–5966, [email protected]. research, emergency response, and Name of Committee: National Institute of Any interested person may file written preparation of toxicological profiles. Nursing Research Special; Emphasis Panel comments with the committee by forwarding Purpose: This ChemRisk study group was Inflammatory Intervention. the statement to the Contact Person listed on charged with locating, evaluating, Date: January 27, 2010. this notice. The statement should include the cataloguing, and copying documents that Time: 10 a.m. to 12 p.m. name, address, telephone number and when contain information about historical Agenda: To review and evaluate contract applicable, the business or professional proposals. chemical or radionuclide releases from affiliation of the interested person. Place: National Institutes of Health, One facilities at the Los Alamos National (Catalogue of Federal Domestic Assistance Laboratory since its inception. The purpose Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892 (Telephone Program Nos. 93.361, Nursing Research, of this meeting is to update the report based National Institutes of Health, HHS) on comments received to date, to discuss Conference Call). progress to date, provide a forum for Contact Person: Tamizchelvi Thyagarajan, Dated: January 6, 2010. community interaction, and serve as a PhD, Scientific Review Officer, National Jennifer Spaeth, vehicle for members of the public to express Institute of Nursing Research, National Institutes of Health, 6701 Democracy Blvd., Director, Office of Federal Advisory concerns and provide comments to CDC. Committee Policy. Matters To Be Discussed: Agenda items Bethesda, MD 20892, (301) 594–0343, tamizchelvi.thyagarajan.nih.gov. [FR Doc. 2010–429 Filed 1–12–10; 8:45 am] include an update presentation from the Any interested person may file written National Center for Environmental Health BILLING CODE 4140–01–P comments with the committee by forwarding (NCEH) and its contractor regarding the statement to the Contact Person listed on comments on the LAHDRA project’s draft this notice. The statement should include the final report. The meeting will include an DEPARTMENT OF HEALTH AND name, address, telephone number and when opening session and update in the morning HUMAN SERVICES applicable, the business or professional session with an optional workshop in the affiliation of the interested person. afternoon in which attendees can express National Institutes of Health concerns and comments with subject matter (Catalogue of Federal Domestic Assistance experts. Program Nos. 93.361, Nursing Research, National Institute of Nursing Research; There will be time for public input, National Institutes of Health, HHS) Notice of Closed Meeting questions, and comments throughout the Dated: January 6, 2010. Pursuant to section 10(d) of the workshop sessions. All agenda items are Jennifer Spaeth, subject to change as priorities dictate. Federal Advisory Committee Act, as Contact Person for Additional Information: Director, Office of Federal Advisory amended (5 U.S.C. App.), notice is Phillip R. Green, Public Health Advisor, Committee Policy. hereby given of the following meeting. Radiation Studies Branch, Division of [FR Doc. 2010–413 Filed 1–12–10; 8:45 am] The meeting will be closed to the Environmental Hazards and Health Effects, BILLING CODE 4140–01–M public in accordance with the NCEH, CDC, 4770 Buford Highway, NE., provisions set forth in sections (Mailstop F–58), Atlanta, Georgia 30341– 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 3717, telephone (770) 488–3748, facsimile DEPARTMENT OF HEALTH AND as amended. The grant applications and (770) 488–1539, e-mail address: HUMAN SERVICES [email protected]. the discussions could disclose confidential trade secrets or commercial National Institutes of Health Dated: January 7, 2010. property such as patentable material, Tanja Popovic, National Institute of Nursing Research; and personal information concerning Chief Science Officer, Centers for Disease Notice of Closed Meeting individuals associated with the grant Control and Prevention. applications, the disclosure of which [FR Doc. 2010–501 Filed 1–12–10; 8:45 am] Pursuant to section 10(d) of the would constitute a clearly unwarranted BILLING CODE 4163–18–P Federal Advisory Committee Act, as invasion of personal privacy. amended (5 U.S.C. App.), notice is Name of Committee: National Institute of hereby given of the following meeting. Nursing Research Special Emphasis Panel, DEPARTMENT OF HEALTH AND The meeting will be closed to the Predoctoral Individual National Research HUMAN SERVICES public in accordance with the Service Award. provisions set forth in sections Date: February 19, 2010. National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 1 p.m. to 5 p.m. as amended. The grant applications and Agenda: To review and evaluate grant National Institute of Nursing Research; the discussions could disclose applications. Notice of Closed Meeting confidential trade secrets or commercial Place: Bethesda Marriott Suites, 6711 property such as patentable material, Democracy Boulevard, Bethesda, MD 20817. Pursuant to section 10(d) of the Contact Person: Weiqun Li, MD, Scientific Federal Advisory Committee Act, as and personal information concerning Review Administrator, National Institute of amended (5 U.S.C. App.), notice is individuals associated with the grant Nursing Research, National Institutes of hereby given of the following meeting. applications, the disclosure of which Health, 6701 Democracy Blvd., Ste. 710, The meeting will be closed to the would constitute a clearly unwarranted Bethesda, MD 20892, (301) 594–5966, public in accordance with the invasion of personal privacy. [email protected].

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Any interested person may file written Contact Person: Ryan G. Morris, PhD, Integrated Review Group, Biomedical comments with the committee by forwarding Scientific Review Officer, Center for Imaging Technology Study Section. the statement to the Contact Person listed on Scientific Review, National Institutes of Date: February 10–12, 2010. this notice. The statement should include the Health, 6701 Rockledge Drive, Room 4205, Time: 7 p.m. to 12 p.m. name, address, telephone number and when MSC 7814, Bethesda, MD 20892. 301–435– Agenda: To review and evaluate grant applicable, the business or professional 1501. [email protected]. applications. affiliation of the interested person. This notice is being published less than 15 Place: Bahia Resort Hotel, 998 West (Catalogue of Federal Domestic Assistance days prior to the meeting due to the timing Mission Bay Drive, San Diego, CA 92109. Program Nos. 93.361, Nursing Research, limitations imposed by the review and Contact Person: Lee Rosen, PhD, Scientific National Institutes of Health, HHS) funding cycle. Review Officer, Center for Scientific Review, Name of Committee: Oncology 1—Basic National Institutes of Health, 6701 Rockledge Dated: January 6, 2010. Translational Integrated Review Group, Drive, Room 5116, MSC 7854, Bethesda, MD Jennifer Spaeth, Tumor Progression and Metastasis Study 20892. (301) 435–1171. [email protected]. Director, Office of Federal Advisory Section. Name of Committee: Vascular and Committee Policy. Date: February 4–5, 2010. Hematology Integrated Review Group, [FR Doc. 2010–428 Filed 1–12–10; 8:45 am] Time: 8 a.m. to 5 p.m. Erythrocyte and Leukocyte Biology Study BILLING CODE 4140–01–P Agenda: To review and evaluate grant Section. applications. Date: February 18, 2010. Place: Sheraton Delfina Santa Monica, 530 Time: 8 a.m. to 4 p.m. West Pico Boulevard, Stella, Santa Monica, Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND CA 90405. HUMAN SERVICES applications. Contact Person: Manzoor Zarger, MS, PhD, Place: Beacon Hotel and Corporate Scientific Review Officer, Center for National Institutes of Health Quarters, 1615 Rhode Island Avenue, NW., Scientific Review, National Institutes of Washington, DC 20036. Health, 6701 Rockledge Drive, Room 6208, Center for Scientific Review; Notice of Contact Person: Delia Tang, MD, Scientific MSC 7804, Bethesda, MD 20892. (301) 435– Review Officer, Center for Scientific Review, Closed Meetings 2477. [email protected]. National Institutes of Health, 6701 Rockledge Pursuant to section 10(d) of the Name of Committee: Digestive, Kidney and Drive, Room 4126, MSC 7802, Bethesda, MD Federal Advisory Committee Act, as Urological Systems Integrated Review Group, 20892. 301–435–2506. [email protected]. Cellular and Molecular Biology of the Kidney Name of Committee: Healthcare Delivery amended (5 U.S.C. App.), notice is Study Section. hereby given of the following meetings. Date: February 8, 2010. and Methodologies, Biomedical Computing The meetings will be closed to the Time: 8 a.m. to 6 p.m. and Health Informatics Study Section. public in accordance with the Agenda: To review and evaluate grant Date: February 18, 2010. provisions set forth in sections applications. Time: 8 a.m. to 5 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: Doubletree Hotel Bethesda, 8120 Agenda: To review and evaluate grant Wisconsin Avenue, Bethesda, MD 20814. applications. as amended. The grant applications and Place: Hyatt Regency Bethesda, One the discussions could disclose Contact Person: Bonnie L. Burgess-Beusse, PhD, Scientific Review Officer, Center for Bethesda Metro Center, 7400 Wisconsin confidential trade secrets or commercial Scientific Review, National Institutes of Avenue, Bethesda, MD 20814. property such as patentable material, Health, 6701 Rockledge Drive, Room 2182, Contact Person: Katherine Bent, PhD, and personal information concerning MSC 7818, Bethesda, MD 20892. 301–435– Scientific Review Officer, Center for individuals associated with the grant 1783. [email protected]. Scientific Review, National Institutes of applications, the disclosure of which Name of Committee: Oncology 2— Health, 6701 Rockledge Drive, Room 3160, would constitute a clearly unwarranted Translational Clinical Integrated Review MSC 7770, Bethesda, MD 20892. 301–435– invasion of personal privacy. Group, Clinical Oncology Study Section. 0695. [email protected]. Date: February 8–9, 2010. Name of Committee: Center for Scientific Name of Committee: Center for Scientific Time: 8 p.m. to 5 p.m. Review Special Emphasis Panel, Risk Review Special Emphasis Panel, Agenda: To review and evaluate grant Prevention and Health Behavior Across the Hematopoietic Cellular Mechanisms. applications. Lifespan. Date: January 21–22, 2010. Place: Hilton Alexandria Old Town, 1767 Date: February 18–19, 2010. Time: 11 a.m. to 1 p.m. King Street, Alexandria, VA 22314. Time: 8:30 a.m. to 5 p.m. Agenda: To review and evaluate grant Contact Person: Malaya Chatterjee, PhD, Agenda: To review and evaluate grant applications. Scientific Review Officer, Center for applications. Place: National Institutes of Health, 6701 Scientific Review, National Institutes of Place: The Westin St. Francis, 335 Powell Rockledge Drive, Bethesda, MD 20892. Street, San Francisco, CA 94102. (Virtual Meeting.) Health, 6701 Rockledge Drive, Room 6192, Contact Person: Bukhtiar H. Shah, DVM, MSC 7804, Bethesda, MD 20892. 301–451– Contact Person: Claire E. Gutkin, PhD, PhD, Scientific Review Officer, Center for 0131. [email protected]. MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Name of Committee: Musculoskeletal, Oral Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4120, and Skin Sciences Integrated Review Group, Health, 6701 Rockledge Drive, Room 3138, MSC 7802, Bethesda, MD 20892. (301) 435– Skeletal Biology Development and Disease MSC 7759, Bethesda, MD 20892. 301–594– 1233. [email protected]. Study Section. 3139. [email protected]. This notice is being published less than 15 Date: February 10–11, 2010. Name of Committee: Cardiovascular and days prior to the meeting due to the timing Time: 8 a.m. to 5 p.m. Respiratory Sciences Integrated Review limitations imposed by the review and Agenda: To review and evaluate grant Group, Electrical Signaling, Ion Transport, funding cycle. applications. and Arrhythmias Study Section. Name of Committee: Center for Scientific Place: Sheraton Delfina Hotel, 530 West Date: February 19, 2010. Review Special Emphasis Panel, CMBK Pico Boulevard, Santa Monica, CA 90405. Time: 8 a.m. to 6:30 p.m. Conflicts. Contact Person: Priscilla B. Chen, PhD, Agenda: To review and evaluate grant Date: January 22, 2010. Scientific Review Officer, Center for applications. Time: 12 p.m. to 2 p.m. Scientific Review, National Institutes of Place: The Westin St. Francis, 335 Powell Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 4104, Street, San Francisco, CA 94102. applications. MSC 7814, Bethesda, MD 20892. (301) 435– Contact Person: Rajiv Kumar, PhD, Place: National Institutes of Health, 6701 1787. [email protected]. Scientific Review Officer, Center for Rockledge Drive, Bethesda, MD 20892. Name of Committee: Surgical Sciences, Scientific Review, National Institutes of (Telephone Conference Call.) Biomedical Imaging and Bioengineering Health, 6701 Rockledge Drive, Room 4122,

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MSC 7802, Bethesda, MD 20892. 301–435– Contact Person: Laurie Friedman Donze, Contact: Richard Panniers, PhD, Scientific 1212. [email protected]. PhD, Scientific Review Officer, Office of Review Officer, Center for Scientific Review, Name of Committee: Center for Scientific Scientific Review, National Center for National Institutes of Health, 6701 Rockledge Review Special Emphasis Panel, Small Complementary, and Alternative Medicine, Drive, Room 2212, MSC 7890, Bethesda, MD Business: Healthcare Delivery and NIH, 6707 Democracy Blvd., Suite 401, 20892, (301) 435–1741, [email protected]. Methodologies. Bethesda, MD 20892, 301–402–1030, This notice is being published less than 15 Date: February 19, 2010. [email protected]. days prior to the meeting due to the timing Time: 8 a.m. to 5 p.m. Name of Committee: National Center for limitations imposed by the review and Agenda: To review and evaluate grant Complementary and Alternative Medicine funding cycle. applications. Special Emphasis Panel, P50 Botanical Name of Committee: Endocrinology, Place: Hyatt Regency Bethesda, One Centers. Metabolism, Nutrition and Reproductive Bethesda Metro Center, 7400 Wisconsin Date: March 3–5, 2010. Sciences Integrated Review Group; Cellular, Avenue, Bethesda, MD 20814. Time: 5 p.m. to 5 p.m. Molecular and Integrative Reproduction Contact Person: Katherine Bent, PhD, Agenda: To review and evaluate grant Study Section. Scientific Review Officer, Center for applications. Date: January 28, 2010. Scientific Review, National Institutes of Place: Courtyard Marriott Washingtonian Time: 8 a.m. to 5 p.m. Health, 6701 Rockledge Drive, Room 3160, Center, 204 Boardwalk Place, Gaithersburg, Agenda: To review and evaluate grant MSC 7770, Bethesda, MD 20892. 301–435– MD 20814. applications. 0695. [email protected]. Contact Person: Martina Schmidt, PhD, Place: Hyatt Regency Bethesda, One (Catalogue of Federal Domestic Assistance Scientific Review Officer, Office of Scientific Bethesda Metro Center, 7400 Wisconsin Program Nos. 93.306, Comparative Medicine; Review, National Center for Complementary, Avenue, Bethesda, MD 20814. 93.333, Clinical Research; 93.306, 93.333, and Alternative Medicine, NIH, 6707 Contact Person: Michael Knecht, PhD, 93.337, 93.393–93.396, 93.837–93.844, Democracy Blvd., Suite 401, Bethesda, MD Scientific Review Officer, Center for 93.846–93.878, 93.892, 93.893, National 20892, 301–594–3456, Scientific Review, National Institutes of Institutes of Health, HHS) [email protected]. Health, 6701 Rockledge Drive, Room 6176, (Catalogue of Federal Domestic Assistance MSC 7892, Bethesda, MD 20892, (301) 435– Dated: January 6, 2010. Program Nos. 93.213, Research and Training 1046, [email protected]. Jennifer Spaeth, in Complementary and Alternative Medicine, This notice is being published less than 15 Director, Office of Federal Advisory National Institutes of Health, HHS) days prior to the meeting due to the timing Committee Policy. limitations imposed by the review and Dated: January 7, 2010. funding cycle. [FR Doc. 2010–427 Filed 1–12–10; 8:45 am] Jennifer Spaeth, Name of Committee: Healthcare Delivery BILLING CODE 4140–01–P Director, Office of Federal Advisory and Methodologies; Nursing Science: Adults Committee Policy. and Older Adults Study Section. Date: February 2–3, 2010. DEPARTMENT OF HEALTH AND [FR Doc. 2010–424 Filed 1–12–10; 8:45 am] BILLING CODE 4140–01–P Time: 8 a.m. to 5 p.m. HUMAN SERVICES Agenda: To review and evaluate grant applications. National Institutes of Health DEPARTMENT OF HEALTH AND Place: Residence Inn Bethesda, 7335 HUMAN SERVICES Wisconsin Avenue, Bethesda, MD 20814. National Center for Complementary Contact Person: Karin F. Helmers, PhD, and Alternative Medicine; Notice of National Institutes of Health Scientific Review Officer, Center for Closed Meetings Scientific Review, National Institutes of Center for Scientific Review; Notice of Health, 6701 Rockledge Drive, Room 3166, Pursuant to section 10(d) of the MSC 7770, Bethesda, MD 20892, 301–254– Closed Meetings Federal Advisory Committee Act, as 9975, [email protected]. amended (5 U.S.C. App.), notice is Pursuant to section 10(d) of the Name of Committee: Center for Scientific hereby given of the following meetings. Federal Advisory Committee Act, as Review Special Emphasis Panel; Member The meetings will be closed to the amended (5 U.S.C. App.), notice is Conflict Applications: CMBK, PBKD and UKGD. public in accordance with the hereby given of the following meetings. The meetings will be closed to the Date: February 2, 2010. provisions set forth in sections Time: 8 a.m. to 7 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., public in accordance with the Agenda: To review and evaluate grant as amended. The grant applications and provisions set forth in sections applications. the discussions could disclose 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Place: National Institutes of Health, 6701 confidential trade secrets or commercial as amended. The grant applications and Rockledge Drive, Bethesda, MD 20892, property such as patentable material, the discussions could disclose (Virtual Meeting) and personal information concerning confidential trade secrets or commercial Contact: Najma Begum, PhD, Scientific individuals associated with the grant property such as patentable material, Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge applications, the disclosure of which and personal information concerning individuals associated with the grant Drive, Room 2186, MSC 7818, Bethesda, MD would constitute a clearly unwarranted 20892, 301–435–1243, [email protected]. invasion of personal privacy. applications, the disclosure of which would constitute a clearly unwarranted Name of Committee: Bioengineering Name of Committee: National Center for Sciences & Technologies Integrated Review Complementary and Alternative Medicine invasion of personal privacy. Group; Microscopic Imaging Study Section. Special Emphasis Panel, Clinical Science— Name of Committee: Center for Scientific Date: February 3–4, 2010. Review of NCCAM Clinical R21 and K Review Special Emphasis Panel; Genetic and Time: 8 a.m. to 5 p.m. Applications. Genomic Analyses of Xenopus. Agenda: To review and evaluate grant Date: February 25–26, 2010. Date: January 27, 2010. applications. Time: 9 a.m. to 5 p.m. Time: 1 p.m. to 5 p.m. Place: National Institutes of Health, 6701 Agenda: To review and evaluate grant Agenda: To review and evaluate grant Rockledge Drive, Bethesda, MD 20892, applications. applications. (Virtual Meeting) Place: Embassy Suites at the Chevy Chase Place: National Institute of Health, 6710 Contact: Malgorzata Klosek, PhD, Scientific Pavilion, 4300 Military Road, NW., Rockledge Drive, Bethesda, MD 20892, Review Officer, Center for Scientific Review, Washington, DC 20015. (Telephone Conference Call). National Institutes of Health, 6701 Rockledge

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Drive, Room 4188, MSC 7849, Bethesda, MD Contact: Maribeth Champoux, PhD, Name of Committee: Center for Scientific 20892, (301) 435–2211, [email protected]. Scientific Review Officer, Center for Review Special Emphasis Panel; Small Name of Committee: Healthcare Delivery Scientific Review, National Institutes of Business Biomedical Sensing, Measurement and Methodologies; Nursing Science: Health, 6701 Rockledge Drive, Room 3170, and Instrumentation [SSMI] (SBIR/STTR) Children and Families Study Section MSC 7848, Bethesda, MD 20892, (301) 594– Date: February 15, 2010. Date: February 4, 2010. 3163, [email protected]. Time: 8 a.m. to 5 p.m. Time: 8 a.m. to 5 p.m. Name of Committee: Endocrinology, Agenda: To review and evaluate grant Agenda: To review and evaluate grant Metabolism, Nutrition and Reproductive applications. applications. Sciences Integrated Review Group; Cellular Place: Bahia Resort Hotel, 998 West Place: Residence Inn Bethesda, 7335 Aspects of Diabetes and Obesity Study Mission Bay Drive, San Diego, CA 92109. Wisconsin Avenue, Bethesda, MD 20814. Section. Contact Person: Guo Feng Xu, PhD, Contact: Karin F. Helmers, PhD, Scientific Date: February 8–9, 2010. Scientific Review Officer, Center for Review Officer, Center for Scientific Review, Time: 8 a.m. to 5 p.m. Scientific Review, National Institutes of National Institutes of Health, 6701 Rockledge Agenda: To review and evaluate grant Health, 6701 Rockledge Drive, Room 5122, Drive, Room 3166, MSC 7770, Bethesda, MD applications. MSC 7854, Bethesda, MD 20892, 301–435– 20892, 301–254–9975, [email protected]. Place: The Fairmont Hotel Washington, 1032, [email protected]. DC, 2401 M Street, NW., Washington, DC Name of Committee: Molecular, Cellular Name of Committee: Musculoskeletal, Oral 20037. and Developmental Neuroscience Integrated and Skin Sciences Integrated Review Group; Contact Person: Ann A. Jerkins, PhD, Review Group; Synapses, Cytoskeleton and Oral, Dental and Craniofacial Sciences Study Scientific Review Officer, Center for Trafficking Study Section. Section. Scientific Review, National Institutes of Date: February 4–5, 2010. Date: February 16–17, 2010. Health, 6701 Rockledge Drive, Room 6154, Time: 8 a.m. to 5 p.m. Time: 8 a.m. to 6 p.m. MSC 7892, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate grant Agenda: To review and evaluate grant 4514, [email protected]. applications. applications. Place: Hilton Alexandria Old Town, 1767 Name of Committee: Center for Scientific Place: Sheraton Delfina Santa Monica, 503 King Street, Alexandria, VA 22314. Review Special Emphasis Panel; Pico Boulevard, Santa Monica, CA 90405. Contact: Jonathan K. Ivins, PhD, Scientific Applications in Mechanisms of Emotion, Contact Person: Yi-Hsin Liu, PhD, Review Officer, Center for Scientific Review, Stress and Health. Scientific Review Officer, Center for National Institutes of Health, 6701 Rockledge Date: February 8, 2010. Scientific Review, National Institutes of Drive, Room 4186, MSC 7850, Bethesda, MD Time: 1 p.m. to 3 p.m. Health, 6701 Rockledge Drive, Room 4214, 20892, (301) 594–1245, [email protected]. Agenda: To review and evaluate grant MSC 7814, Bethesda, MD 20892, 301–451– applications. 1327, [email protected]. Name of Committee: Endocrinology, Place: The Fairmont Hotel Washington, Metabolism, Nutrition and Reproductive Name of Committee: Infectious Diseases DC, 2401 M Street, NW., Washington, DC Sciences Integrated Review Group; Clinical and Microbiology Integrated Review Group; 20037. and Integrative Diabetes and Obesity Study Bacterial Pathogenesis Study Section. Contact Person: Jane A. Doussard- Date: February 16, 2010. Section. Roosevelt, PhD, Scientific Review Officer, Date: February 4–5, 2010. Time: 8 a.m. to 6 p.m. Center for Scientific Review, National Agenda: To review and evaluate grant Time: 8 a.m. to 5 p.m. Institutes of Health, 6701 Rockledge Drive, Agenda: To review and evaluate grant applications. Room 3184, MSC 7848, Bethesda, MD 20892, Place: The Ritz-Carlton Hotel, 1150 22nd applications. (301) 435–4445, [email protected]. Place: Hyatt Regency Bethesda, One Street, NW., Washington, DC 20037. Bethesda Metro Center, 7400 Wisconsin Name of Committee: Center for Scientific Contact Person: Richard G. Kostriken, PhD, Avenue, Bethesda, MD 20814. Review Special Emphasis Panel; Biomedical Scientific Review Officer, Center for Contact: Nancy Sheard, SCD, Scientific Imaging and Bioengineering. Scientific Review, National Institutes of Review Officer, Center for Scientific Review, Date: February 9, 2010. Health, 6701 Rockledge Drive, Room 3192, Time: 11:30 a.m. to 4 p.m. National Institutes of Health, 6701 Rockledge MSC 7808, Bethesda, MD 20892, (301) 402– Agenda: To review and evaluate grant Drive, Room 6046–E, MSC 7892, Bethesda, 4454, [email protected]. applications. MD 20892, (301) 435–1154, Name of Committee: Healthcare Delivery Place: National Institutes of Health, 6701 [email protected]. and Methodologies; Biostatistical Methods Rockledge Drive, Bethesda, MD 20892, Name of Committee: Healthcare Delivery and Research Design Study Section. (Virtual Meeting) Date: February 17, 2010. and Methodologies; Health Services Contact Person: Dharam S. Dhindsa, DVM, Organization and Delivery Study Section. Time: 8 a.m. to 5 p.m. PhD, Scientific Review Officer, Center for Agenda: To review and evaluate grant Date: February 4–5, 2010. Scientific Review, National Institutes of Time: 8 a.m. to 6 p.m. applications. Health, 6701 Rockledge Drive, Room 5110, Place: Melrose Hotel, 2430 Pennsylvania Agenda: To review and evaluate grant MSC 7854, Bethesda, MD 20892, (301) 435– Avenue, NW., Washington, DC 20037. applications. 1174, [email protected]. Place: Hyatt Regency Bethesda, One Contact Person: Denise Wiesch, PhD, Name of Committee: Endocrinology, Scientific Review Officer, Center for Bethesda Metro Center, 7400 Wisconsin Metabolism, Nutrition and Reproductive Avenue, Bethesda, MD 20814. Scientific Review, National Institutes of Sciences Integrated Review Group; Health, 6701 Rockledge Drive, Room 3150, Contact: Kathy Salaita, SCD, Scientific Integrative Nutrition and Metabolic Processes Review Officer, Center for Scientific Review, MSC 7770, Bethesda, MD 20892, (301) 435– Study Section. 0684, [email protected]. National Institutes of Health, 6701 Rockledge Date: February 11, 2010. (Catalogue of Federal Domestic Assistance Drive, Room 3172, MSC 7770, Bethesda, MD Time: 7 a.m. to 6 p.m. Program Nos. 93.306, Comparative Medicine; 20892, 301–451–8504, [email protected]. Agenda: To review and evaluate grant Name of Committee: Biobehavioral and applications. 93.333, Clinical Research, 93.306, 93.333, Behavioral Processes Integrated Review Place: Bethesda North Marriott Hotel & 93.337, 93.393–93.396, 93.837–93.844, Group; Biobehavioral Mechanisms of Conference Center, Montgomery County 93.846–93.878, 93.892, 93.893, National Emotion, Stress and Health Study Section. Conference Center Facility, 5701 Marinelli Institutes of Health, HHS) Date: February 8, 2010. Road, Bethesda, MD 20852. Dated: January 6, 2010. Time: 8 a.m. to 6 p.m. Contact Person: Sooja K. Kim, PhD, Jennifer Spaeth, Agenda: To review and evaluate grant Scientific Review Officer, Center for Director, Office of Federal Advisory applications. Scientific Review, National Institutes of Committee Policy. Place: The Fairmont Hotel Washington, Health, 6701 Rockledge Drive, Room 6182, DC, 2401 M Street, NW., Washington, DC MSC 7892, Bethesda, MD 20892, (301) 435– [FR Doc. 2010–422 Filed 1–12–10; 8:45 am] 20037. 1780, [email protected]. BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND Compositions and Methods of Use geographic territories. For avoidance of HUMAN SERVICES Thereof’’ [HHS Ref. No. E–191–2002/0– doubt, the field of use will specifically CA–06]; exclude rheumatoid arthritis and other National Institutes of Health • U.S. Patent No. 7,521,475 issued osteo-specific autoimmune diseases. April 21, 2009 entitled ‘‘Chondropsin- DATES: Only written comments and/or Prospective Grant of Exclusive Class Antitumor V–ATPase Inhibitor applications for a license which are License: Development of V–ATPase Compounds, Compositions and received by the NIH Office of Inhibitor Compounds for the Treatment Methods of Use Thereof’’ [HHS Ref. No. Technology Transfer on or before of Human Cancers and Osteoclastic E–191–2002/0–US–07]; February 12, 2010 will be considered. Bone Diseases Excluding Rheumatoid • U.S. Patent Application No. 12/ ADDRESSES: Requests for copies of the Arthritis and Other Osteo-Specific 402,560 filed March 12, 2009 entitled Auto-Immune Diseases patent application, inquiries, comments, ‘‘Chondropsin-Class Antitumor V– and other materials relating to the AGENCY: National Institutes of Health, ATPase Inhibitor Compounds, contemplated exclusive license should Public Health Service, HHS. Compositions and Methods of Use be directed to: Sabarni K. Chatterjee, ’’ ACTION: Notice. Thereof [HHS Ref. No. E–191–2002/0– PhD Licensing and Patenting Associate, US–08]; Cancer Branch, Office of Technology SUMMARY • U.S. Provisional Patent Application : This is notice, in accordance Transfer, National Institutes of Health, No. 60/220,270 filed July 24, 2000 with 35 U.S.C. 209(c)(1) and 37 CFR 6011 Executive Boulevard, Suite 325, entitled ‘‘Biologically Active Macrolides, Part 404.7(a)(1)(i), that the National Rockville, MD 20852–3804; Telephone: Compositions, and Uses Thereof’’ [HHS Institutes of Health, Department of (301) 435–5587; Facsimile: (301) 435– Ref. No. E–203–2000/0–US–01]; Health and Human Services, is 4013; e-mail: [email protected]. contemplating the grant of an exclusive • International Patent Application SUPPLEMENTARY INFORMATION: patent license to practice the inventions No. PCT/US01/23633 filed July 24, 2001 The embodied in the following U.S. Patents entitled ‘‘Biologically Active Macrolides, technology describes the class of and Patent Applications to the Compositions, and Uses Thereof’’ [HHS Chondropsin compounds and its Australian Institute of Marine Science Ref. No. E–203–2000/0–PCT–02]; derivatives. The compounds can be (‘‘AIMS’’) located in Townsville, • US Patent No. 7,144,918 issued potentially developed into new Queensland, Australia. December 5, 2006 entitled ‘‘Biologically therapeutics for cancer, osteoporosis, Active Macrolides, Compositions, and and Alzheimer’s diseases. Intellectual Property Uses Thereof’’ [HHS Ref. No. E–203– Briefly, vacuolar type (H+) ATPase • U.S. Provisional Patent Application 2000/0–US–04]; (V–ATPase) has been described as ‘‘a No. 60/398,092 filed July 24, 2002 • US Patent Application No. 11/ universal proton pump of eukaryotes’’. entitled ‘‘Chondropsin-Class Antitumor 435,189 filed May 16, 2006 entitled V–ATPase is responsible for V–ATPase Inhibitor Compounds, ‘‘Biologically Active Macrolides, maintaining internal acidity and is Compositions and Methods of Use Compositions, and Uses Thereof’’ [HHS important in myriad of physiological Thereof’’ [HHS Ref. No. E–191–2002/0– Ref. No. E–203–2000/0–US–08]; functions, such as sorting of membrane US–01]; • Australian Patent No. 200112808 proteins, proinsulin conversion, • International Patent Application issued November 30, 2006 entitled neurotransmitter uptake, and cellular No. PCT/US03/23290 filed July 24, 2003 ‘‘Biologically Active Macrolides, degradation process. This technology entitled ‘‘Chondropsin-Class Antitumor Compositions, and Uses Thereof’’ [HHS describes a new chondropsin, V–ATPase Inhibitor Compounds, Ref. No. E–203–2000/0–US–03]; Poecillastrin-A, a cytotoxic, 33-member Compositions and Methods of Use • European Patent Application No. ring, macrolide lactam, isolated from the Thereof’’ [HHS Ref. No. E–191–2002/0– 01959257.5 filed July 24, 2001 entitled sponge Poecillastra sp. It is structurally PCT–02]; ‘‘Biologically Active Macrolides, related to the chondropsin class of • U.S. Patent Application No. 10/ Compositions, and Uses Thereof’’ [HHS macrolide lactams. However, it 521,930 filed April 18, 2005 entitled Ref. No. E–203–2000/0–EP–05]; possesses unique patterns of ‘‘Chondropsin-Class Antitumor V– • Canadian Patent Application No. methylation and oxygenation, and it is ATPase Inhibitor Compounds, 2415611 filed July 24, 2001 entitled the first member of this family of Compositions and Methods of Use ‘‘Biologically Active Macrolides, polyketide derivatives with a 33- Thereof’’ [HHS Ref. No. E–191–2002/0– Compositions, and Uses Thereof’’ [HHS membered macrocyclic ring. The in US–03]; Ref. No. E–203–2000/0–CA–06]; and vitro anti-tumor activity of the • European Patent Application No. • Japanese Patent Application No. compound is comparable to that of the 03751813.1 filed February 16, 2005 514137/2002 filed July 24, 2001 entitled chondropsins, however the new entitled ‘‘Chondropsin-Class Antitumor ‘‘Biologically Active Macrolides, structural features found in V–ATPase Inhibitor Compounds, Compositions, and Uses Thereof’’ [HHS Poecillastrin-A broaden the known Compositions and Methods of Use Ref. No. E–203–2000/0–JP–07]. structural diversity of this family of Thereof’’ [HHS Ref. No. E–191–2002/0– The patent rights in these inventions potent anti-proliferative and cytotoxic EP–04]; have been assigned to the United States macrolide lantams. The chondropsins • Australian Patent Application No. of America. and poecillastrin A produce a 2003269924 filed February 4, 2005 The prospective exclusive license distinctive pattern of differential entitled ‘‘Chondropsin-Class Antitumor territory may be worldwide and the cytotoxicity in the NCI’s 60 cell V–ATPase Inhibitor Compounds, field of use may be for ‘‘use of Licensed antitumor screen that directly correlates Compositions and Methods of Use Patent Rights for use and development with selective V–ATPase inhibitors. Thereof’’ [HHS Ref. No. E–191–2002/0– of pharmaceutically suitable V–ATPase This class of compounds and its’ AU–05]; Inhibitor compounds for the treatment derivatives have the potential of being • Canadian Patent Application No. of human cancers, including used as a therapeutics against several 2493821 filed January 24, 2005 entitled osteosarcoma, and osteoclastic bone cancer types and may have applicability ‘‘Chondropsin-Class Antitumor V– diseases, such as osteoporosis, as highly selective anti-cancer small ATPase Inhibitor Compounds, osteopenia and Paget’s disease, ’’ in ‘‘all’’ molecule inhibitors. Additionally, it has

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the potential of being used for the agencies. This proposed information submission is being made to extend the treatment of several other diseases such collection was previously published in expiration date. as osteoporosis, and Alzheimer’s the Federal Register (74 FR 58036) on Type of Review: Extension (without diseases. November 10, 2009, allowing for a 60- change). The prospective exclusive license will day comment period. This notice allows Affected Public: Businesses, be royalty bearing and will comply with for an additional 30 days for public Individuals. the terms and conditions of 35 U.S.C. comments. This process is conducted in Reporting 209 and 37 CFR part 404.7. The accordance with 5 CFR 1320.10. prospective exclusive license may be DATES: Written comments should be Estimated Number of Respondents: granted unless within thirty (30) days received on or before February 12, 2010. 200. Estimated Number of Responses per from the date of this published notice, ADDRESSES: Interested persons are the NIH receives written evidence and invited to submit written comments on Respondent: 1. argument that establishes that the grant this proposed information collection to Estimated Number of Total of the license would not be consistent the Office of Information and Regulatory Responses: 200. Estimated Time per Response: 75 with the requirements of 35 U.S.C. 209 Affairs, Office of Management and minutes. and 37 CFR part 404.7. Budget. Comments should be addressed Estimated Total Burden Hours: 250. Applications for a license in the field to the OMB Desk Officer for Customs of use filed in response to this notice and Border Protection, Department of Recordkeeping will be treated as objections to the grant Homeland Security, and sent via of the contemplated exclusive license. Estimated Number of Recordkeepers: electronic mail to 200. Comments and objections submitted to [email protected] or faxed this notice will not be made available Estimated Time per Recordkeeper: 60 to (202) 395–5806. minutes. for public inspection and, to the extent SUPPLEMENTARY INFORMATION: U.S. permitted by law, will not be released Estimated Total Burden Hours: 200. Customs and Border Protection (CBP) If additional information is required under the Freedom of Information Act, encourages the general public and contact: Tracey Denning, U.S. Customs 5 U.S.C. 552. affected Federal agencies to submit and Border Protection, Office of Dated: December 29, 2009. written comments and suggestions on Regulations and Rulings, 799 9th Street, Richard U. Rodriguez, proposed and/or continuing information NW., 7th Floor, Washington, DC 20229– Director, Division of Technology Development collection requests pursuant to the 1177, at 202–325–0265. and Transfer, Office of Technology Transfer, Paperwork Reduction Act (Pub. L. 104– Dated: January 7, 2009. National Institutes of Health. 13). Your comments should address one Tracey Denning, [FR Doc. 2010–420 Filed 1–12–10; 8:45 am] of the following four points: Agency Clearance Officer, U.S. Customs and BILLING CODE 4140–01–P (1) Evaluate whether the proposed collection of information is necessary Border Protection. for the proper performance of the [FR Doc. 2010–464 Filed 1–12–10; 8:45 am] DEPARTMENT OF HOMELAND functions of the agency/component, BILLING CODE 9111–14–P SECURITY including whether the information will have practical utility; U.S. Customs and Border Protection (2) Evaluate the accuracy of the DEPARTMENT OF HOMELAND agencies/components estimate of the SECURITY Agency Information Collection burden of The proposed collection of Activities: Accreditation of Commercial information, including the validity of Coast Guard Laboratories and Approval of the methodology and assumptions used; [Docket No. USCG–2009–0299] Commercial Gaugers (3) Enhance the quality, utility, and clarity of the information to be Terminate Long Range Aids to AGENCY: U.S. Customs and Border collected; and Navigation (Loran-C) Signal Protection, Department of Homeland (4) Minimize the burden of the Security. collections of information on those who AGENCY: U.S. Coast Guard, DHS. ACTION: 30-Day notice and request for are to respond, including the use of ACTION: Notice; correction. comments; Extension of an existing appropriate automated, electronic, information collection: 1651–0053. mechanical, or other technological SUMMARY: The Coast Guard is correcting techniques or other forms of a notice that appeared in the Federal SUMMARY: U.S. Customs and Border information. Register of January 7, 2010 (75 FR 998). Protection (CBP) of the Department of Title: Accreditation of Commercial The document announced termination Homeland Security has submitted the Laboratories and Approval of of the Long Range Aids to Navigation following information collection request Commercial Gaugers. (Loran-C) Signal commencing on or to the Office of Management and Budget OMB Number: 1651–0053. about February 8, 2010. The document (OMB) for review and approval in Form Number: None. had an incorrect word in the DATES accordance with the Paperwork Abstract: Commercial gaugers and section. Reduction Act: Accreditation of laboratories seeking accreditation or DATES: Effective January 13, 2010. Commercial Laboratories and Approval approval must provide the information FOR FURTHER INFORMATION CONTACT: of Commercial Gaugers. This is a specified in 19 CFR 151.12 and/or 19 If proposed extension of an information CFR 151.13 to CBP. CBP uses this you have questions on this notice, collection that was previously information in deciding whether to contact Mr. Mike Sollosi, U.S. Coast approved. CBP is proposing that this approve individuals or businesses Guard, Department of Homeland information collection be extended with desiring to measure bulk products or to Security, telephone (202) 372–1545, no change to the burden hours. This analyze importations [email protected]. document is published to obtain Current Actions: There are no changes SUPPLEMENTARY INFORMATION: In the comments from the public and affected to the information collection. This Federal Register of January 7, 2010, in

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FR Doc. 2010–83, on page 998 in the SUPPLEMENTARY INFORMATION: OMB owned roads that are included in second column under DATES, correct regulations at 5 CFR 1320 (which reciprocal right-of-way agreements. ‘‘Transmission of the Loran-C signal and implement provisions of the Paperwork Total Annual Responses: 40. phased decommissioning of the Loran- Reduction Act, 44 U.S.C. 3501–352) Response Time: 20 minutes. C infrastructure will commence on or require that interested members of the Total Annual Burden Hours for about February 8, 2010’’ to read: public and affected agencies be given an Respondents: 13 hours. ‘‘Termination of the Loran-C signal and opportunity to comment on information Jean Sonneman, phased decommissioning of the Loran- collection and recordkeeping activities C infrastructure will commence on or Acting Information Collection Clearance (see 5 CFR 1320.8 (d) and 1320.12(a)). Officer, Bureau of Land Management. about February 8, 2010.’’ This notice identifies a collection of [FR Doc. 2010–502 Filed 1–12–10; 8:45 am] Dated: January 7, 2010. information that the BLM will be BILLING CODE 4310–84–P Mark W. Skolnicki, submitting to OMB for approval. Commander, U.S. Coast Guard, Acting Chief, Comments are invited on: (1) The Office of Regulations and Administrative Law. need for the collection of information DEPARTMENT OF THE INTERIOR [FR Doc. 2010–439 Filed 1–12–10; 8:45 am] for the performance of the functions of BILLING CODE 9110–04–P the agency; (2) the accuracy of the National Park Service agency’s burden estimates; (3) ways to enhance the quality, utility and clarity 60-Day Notice of Intention To Request Clearance of Collection of Information; DEPARTMENT OF THE INTERIOR of the information collection; and (4) ways to minimize the information Opportunity for Public Comment collection burden on respondents, such Bureau of Land Management AGENCY: Department of Interior, as use of automated means of collection National Park Service. [L63330000–PH0000–LLWO270000; OMB of the information. A summary of the Control Number 1004–0102] public comments will accompany the ACTION: Notice and request for comments. Notice of Proposed Information BLM’s submission of the information collection requests to OMB. Collection for 1004–0102 SUMMARY: Under the provisions of the Before including your address, phone Paperwork Reduction Act of 1995 and 5 AGENCY: Bureau of Land Management, number, e-mail address, or other Interior. CFR part 1320, Reporting and Record personal identifying information in your Keeping Requirements, the National ACTION: 60-Day Notice and Request for comment, you should be aware that Park Service (NPS) invites public Comments. your entire comment–including your comments on a new collection of personal identifying information–may SUMMARY: information. In compliance with the be made publicly available at any time. Paperwork Reduction Act of 1995, the While you can ask us in your comment DATES: Public comments on this Bureau of Land Management (BLM) is to withhold your personal identifying Information Collection Request (ICR) announcing its intention to request information from public review, we will be accepted on or before March 15, reinstatement of an approval to collect cannot guarantee that we will be able to 2010. information that documents the do so. ADDRESSES: Send comments to: Brian payment of road use fees for the use of The following information is provided Mitchell, Northeast Temperate privately owned roads to haul timber for the information collection: Inventory and Monitoring Network, sold in accordance with BLM sale NPS, 54 Elm Street, Woodstock, VT contracts. This information collection Title: Road Use Fees Paid Report. 05091; or via fax at 802–457–3405; or activity was previously approved by the OMB Control Number: 1004–0102. via e-mail at [email protected]. Office of Management and Budget Summary: Most purchasers of timber All responses to the Notice will be (OMB), and assigned the control number from BLM-managed lands use both summarized and included in the request 1004–0102. federal and private roads to haul the timber. In such instances, the timber for the Office of Management and DATES: Comments on the proposed Budget (OMB) approval. All comments information collection must be received sale contract with the BLM requires the purchaser to pay private landowners for will become a matter of public record. by March 15, 2010, to be assured of To Request a Draft of Proposed consideration. the use and/or maintenance of their roads. These fees represent the BLM’s Collection of Information Contact: Brian ADDRESSES: Comments may be mailed to share of road construction and Mitchell, NPS, 54 Elm Street, U.S. Department of the Interior, Bureau maintenance costs under reciprocal Woodstock, VT 05091; or via phone at of Land Management, Mail Stop 401– right-of-way agreements between the 802/457–3368; or via fax at 802/457– LS, 1849 C St., NW., Washington, DC BLM and private landowners. See 43 3368; or via e-mail at 20240. Comments may also be U.S.C. 1762; 43 CFR subpart 2812. This [email protected]. You are submitted electronically to information collection is a report that entitled to a copy of the entire ICR _ Jean [email protected]. Please attach timber sale purchasers submit to the package free of charge once the package ‘‘Attn: 1004–0102’’ to either form of BLM to show that they have paid the is submitted to OMB for review. comment. fees required by their timber sale SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: To contracts. The BLM uses the report to Title: Citizen Science Phenology receive a copy of the information ensure compliance with the timber sale Monitoring in National Parks. collection request, contact Richard contract, and to amortize road Form(s): None. Watson, 303–236–0158. Persons who construction and maintenance costs Type of Request: A new collection of use a telecommunication device for the among several road users. information. deaf (TDD) may call the Federal Frequency of Collection: On occasion. Description of Need: The Government Information Relay Service (FIRS) on 1– Description of Respondents: Timber Performance and Results Act (GPRA) of 800–877–8339, 24 hours a day, seven sale purchasers that haul timber 1995 (Pub. Law 103–62) and the days a week, to contact Mr. Watson. purchased from the BLM over privately National Park Service (NPS) Strategic

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Plan require that the NPS develop goals Estimated average time burden per T. 11 N., R. 3 E., to improve program effectiveness and respondent: 30 minutes. Secs. 7, 11, 13, and 18; public accountability. This collection Estimated total annual reporting Secs. 19, 24, and 25. will encourage the public to collect data burden: 100 hours per year. Containing approximately 3,616 acres. relevant to goal 1b: ‘‘The National Park Comments are invited on: (1) The T. 11 N., R. 4 E., Service contributes to knowledge about practical utility of the information being Secs. 19, 20, and 30. natural and cultural resources and gathered; (2) the accuracy of the burden Containing approximately 1,376 acres. associated values; management hour estimate; (3) ways to enhance the Aggregating approximately 17,288 acres. decisions about resources and visitors quality, utility, and clarity of the The subsurface estate in these lands are based on adequate scholarly and information being collected; and (4) will be conveyed to Arctic Slope scientific information’’. This collection ways to minimize the burden to Regional Corporation when the surface is also consistent with the NPS respondents, including use of estate is conveyed to Kuukpik Management Policies (2006), which automated information collection Corporation. Notice of the decision will emphasize the ‘‘use of qualitative and techniques or other forms of information also be published four times in the quantitative techniques to monitor key technology. Before including your Arctic Sounder. aspects of resources and processes at address, phone number, e-mail address, DATES: The time limits for filing an regular intervals’’ and furthermore state or other personal identifying appeal are: that ‘‘studies, research, and collection information in your comment, you 1. Any party claiming a property activities by non-NPS personnel should be aware that your entire interest which is adversely affected by involving natural and cultural resources comment—including your personal the decision shall have until February will be encouraged and facilitated when identifying information—may be made 12, 2010 to file an appeal. they otherwise comport with NPS publicly available at any time. While 2. Parties receiving service of the policies.’’ More specifically, the goal of you can ask us in your comment to decision by certified mail shall have 30 this collection is to engage the public in withhold your personal identifying days from the date of receipt to file an documenting the timing of biological information from public review, we appeal. events (‘‘phenology’’) for a variety of cannot guarantee that we will be able to Parties who do not file an appeal in species at numerous different locations. do so. accordance with the requirements of 43 The data collected will help the NPS December 23, 2009. CFR part 4, Subpart E, shall be deemed document how climate change is Cartina A. Miller, to have waived their rights. affecting the timing of biological events Information Collection Clearance Officer, ADDRESSES: A copy of the decision may such as migration, flowering, and National Park Service. be obtained from: Bureau of Land autumn foliage. [FR Doc. 2010–446 Filed 1–12–10; 8:45 am] Management, Alaska State Office, 222 The proposed Internet- and paper- BILLING CODE P West Seventh Avenue, #13, Anchorage, based surveys will ask the public to Alaska 99513–7504. participate in the collection of these FOR FURTHER INFORMATION CONTACT: The data on NPS lands. With sufficient DEPARTMENT OF THE INTERIOR Bureau of Land Management by phone participation, NPS will obtain critical at 907–271–5960, or by e-mail at information for determining trends in Bureau of Land Management [email protected]. Persons the timing of biological events for many who use a telecommunication device species. In addition to documenting [F–14909–B, F–14909–B2, F–19148–38; LLAK964000–L14100000–KC0000–P] (TTD) may call the Federal Information changes in timing of events, the data set Relay Service (FIRS) at 1–800–877– will facilitate the identification of Alaska Native Claims Selection 8339, 24 hours a day, seven days a species most at risk from climate change week, to contact the Bureau of Land AGENCY: Bureau of Land Management, and anthropogenic influences. Survey Management. participants will provide their contact Interior. information and multiple observations ACTION: Notice of decision approving Michael Bilancione, of species at one or more sites. The lands for conveyance. Land Transfer Resolution Specialist, Land contact information will be used for Transfer Adjudication I Branch. quality control and (at the request of the SUMMARY: As required by 43 CFR [FR Doc. 2010–449 Filed 1–12–10; 8:45 am] participant) to provide data summaries 2650.7(d), notice is hereby given that an BILLING CODE 4310–JA–P or reports and information about appealable decision approving the additional opportunities for assisting surface estate in certain lands for with NPS research and monitoring conveyance pursuant to the Alaska DEPARTMENT OF THE INTERIOR activities. The obligation to respond is Native Claims Settlement Act will be voluntary. issued to Kuukpik Corporation. The Bureau of Land Management Automated Data Collection: The lands are in the vicinity of Nuiqsut, [CACA 048649, LLCAD06000 L51010000 information will be collected through an Alaska, and are located in: FX0000 LVRWB09B2520] Internet site, as well as through paper Umiat Meridian, Alaska forms available at public locations. Notice of Intent To Prepare an T. 10 N., R. 2 E., Environmental Impact Statement for Description of respondents: Secs. 1, 2, and 3; Respondents are members of the public Secs. 5 to 10, inclusive; the Proposed First Solar Desert with an interest in contributing to Secs. 16, 17, and 18; Sunlight Solar Farm Project, Riverside climate change research in the National Secs. 20, 21, and 29. County, CA and Possible Land Use Parks. Containing approximately 8,751 acres. Plan Amendment Estimated average number of T. 11 N., R. 2 E., AGENCY: Bureau of Land Management, responses: 1,000 per year. Secs. 24, 25, and 26; Interior. Frequency of Response: 5 per Secs. 34, 35, and 36. ACTION: Notice of intent. respondent. Containing approximately 3,545 acres.

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SUMMARY: In compliance with the a solar photovoltaic generating facility participate in the scoping process and, National Environmental Policy Act with a proposed output of 550 if eligible, may request or be requested (NEPA) of 1969, as amended, and the megawatts and a project footprint of by the BLM to participate as a Federal Land Policy and Management approximately 4,410 acres. The cooperating agency. Act of 1976, as amended, the Bureau of proposed project would be located on Before including your address, phone Land Management (BLM) Palm Springs BLM-administered lands in Riverside number, e-mail address, or other South Coast Field Office, Palm Springs, County approximately 6 miles north of personal identifying information in your California, intends to prepare an the rural community of Desert Center, comment, you should be aware that Environmental Impact Statement (EIS) California. The overall site layout and your entire comment—including your for First Solar Inc.’s application for a generalized land uses would include a personal identifying information—may right-of-way authorization to develop a substation, an administration building, be made publicly available at any time. solar photovoltaic generating facility. operations and maintenance facilities, a While you can ask us in your comment The EIS may also support an transmission line, and temporary to withhold your personal identifying amendment to the California Desert construction lay down areas. The information from public review, we Conservation Area (CDCA) Plan (1980), project’s 230-kilovolt (kV) generation cannot guarantee that we will be able to as amended; by this notice the BLM is interconnection transmission line also do so. announcing the beginning of the would be located on BLM-administered scoping process to solicit public lands and would utilize a planned 230- Thomas Pogacnik, comments and identify issues. to 500-kV substation (referred to as the Deputy State Director, California. DATES: This notice initiates the public Red Bluff substation). The Red Bluff Authority: 40 CFR 1501.7 and 43 CFR scoping process for the EIS and possible substation would connect the project to 1610.2. plan amendment. Comments on issues the Southern California Edison regional [FR Doc. 2010–403 Filed 1–12–10; 8:45 am] transmission grid. Should the project be may be submitted in writing until BILLING CODE 4310–40–P February 12, 2010. The date(s) and approved, the interconnection location(s) of any scoping meetings will transmission line would be about 9 be announced at least 15 days in miles to about 13 miles long, depending DEPARTMENT OF THE INTERIOR advance through the local media, and on the alternative selected. If approved, the BLM Web site at: http:// construction would begin in late 2010 National Park Service www.blm.gov/ca/st/en/fo/ and would take approximately 41 palmsprings.html. In order to be months to complete. Termination of the Environmental considered in the Draft EIS, all The purpose of the public scoping Impact Statement for the General comments must be received prior to the process is to determine relevant issues Management Plan, Gila Cliff Dwellings close of the scoping period or 15 days that will influence the scope of the National Monument environmental analysis, including after the last public meeting, whichever AGENCY: National Park Service, is later. The BLM will provide alternatives, and guide the process for developing the EIS. At present, the BLM Department of the Interior. additional opportunities for public has identified the following preliminary ACTION: Notice of termination of the participation upon publication of the issues: Air quality, biological resources, Environmental Impact Statement for the Draft EIS. recreation, cultural resources, water General Management Plan, Gila Cliff ADDRESSES: You may submit comments resources, geological resources, special Dwellings National Monument, New on issues and planning criteria related management areas, land use, noise, Mexico. to the First Solar Desert Sunlight Solar paleontological resources, public health, Farm Draft EIS/Plan Amendment by any socioeconomic, soils, traffic and SUMMARY: The National Park Service of the following methods: (NPS) is terminating the Environmental • transportation, visual resources, and Web site: http://www.blm.gov/ca/st/ other issues. Authorization of this Impact Statement (EIS) for the Gila Cliff en/fo/palmsprings.html; proposal may require amendment of the Dwellings General Management Plan • E-mail: CAPSSolarFirstSolar CDCA Plan. By this notice, the BLM is because it has determined that an [email protected]; Environmental Assessment (EA) is the • complying with requirements in 43 CFR Fax: (760) 833–7199; or more appropriate National • Mail: Allison Shaffer, Project 1610.2(c) to notify the public of potential amendments to land use plans, Environmental Policy Act compliance Manager, Palm Springs South Coast document. A Notice of Intent to prepare Field Office, BLM, 1201 Bird Center based on the findings of the EIS. If a land use plan amendment is necessary, the EIS for the Gila Cliff Dwellings Drive, Palm Springs, California 92262. General Management Plan was Documents pertinent to this proposal the BLM will integrate the land use planning process with the NEPA published on April 16, 2008 (Federal may be examined at the Palm Springs Register Vol. 73, No. 74). Scoping South Coast Field Office. process for this project. The BLM will use and coordinate the conducted for the plan indicated that FOR FURTHER INFORMATION CONTACT: For NEPA commenting process to satisfy the there were no significant impacts or further information or to have your public involvement process for Section controversy identified by the public. A name added to our mailing list, contact 106 of the National Historic preliminary impact analysis indicated Allison Shaffer, BLM Project Manager, Preservation Act (16 U.S.C. 470f) as that the alternatives have limited telephone (760) 833–7100; address Palm provided for in 36 CFR 800.2(d)(3). potential to result in significant/major Springs South Coast Field Office, BLM, Native American tribal consultations effects on the human environment as 1201 Bird Center Drive, Palm Springs, will be conducted and tribal concerns, they focus on different ways of California 92262; e-mail including impacts on Indian trust assets, protecting resources, providing CAPSSolarFirstSolarDesertSunlight@ will be given appropriate consideration. appropriate visitor experiences, and blm.gov. Federal, State, and local agencies— addressing joint NPS/Forest Service SUPPLEMENTARY INFORMATION: The along with other stakeholders who may operations. For these reasons the NPS applicant, First Solar Inc., has requested be interested or affected by the BLM’s determined the proposal would not a right-of-way authorization to develop decision on this project—are invited to require an EIS.

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DATES: The request to terminate the DEPARTMENT OF THE INTERIOR a haven for a diversity of native flora Environmental Impact Statement and and fauna, including endemic, proceed with an Environmental Fish and Wildlife Service threatened, endangered, and candidate species. Assessment was approved by the Chief [FWS–R4–R–2009–N162; 40136–1265–0000– of the NPS Environmental Quality S3] Key West NWR Division on November 4, 2009. The Located west of Key West and draft general management plan and Lower Florida Keys Refuges, Monroe accessible only by boat, the refuge Environmental Assessment is expected County, FL consists of the Marquesas Keys and 13 to be distributed for a 30 day public AGENCY: Fish and Wildlife Service, other keys distributed across over 375 comment period early in 2011 and a Interior. square miles of open water. Key West decision is expected be made in the fall ACTION: Notice of availability: final NWR is among the first refuges of 2011. The NPS will notify the public Comprehensive Conservation Plan and established in the United States. by mail, Web site, and other means, and finding of no significant impact. President Roosevelt created the refuge will include information on where and in 1908 as a preserve and breeding how to obtain a copy of the GMP/EA, SUMMARY: We, the Fish and Wildlife ground for colonial nesting birds and how to comment on the plan, and the Service (Service), announce our other wildlife. The refuge encompasses dates of the public comment period. decision and the availability of the final 208,308 acres of land and water with CCP and finding of no significant only 1 percent (2,019 acres) being land. FOR FURTHER INFORMATION CONTACT: impact (FONSI) for the Environmental Most islands are dominated by Steve Riley, Superintendent, Gila Cliff Assessment for the Lower Florida Keys mangrove plant communities. Dwellings National Monument, HC 68 Refuges in accordance with the National The refuge provides habitat and Box 100, Silver City, NM 88061. Environmental Policy Act (NEPA) protection for Federally listed species, Telephone (575) 536–9461. requirements. We completed a thorough including piping plovers and roseate SUPPLEMENTARY INFORMATION: In place of analysis of impacts on the human terns. The refuge harbors the largest the EIS, the NPS will prepare an environment, which are included in the wintering population of piping plovers Environmental Assessment (EA) that Environmental Assessment (Appendix and the largest colony of white-crowned pigeons in the Florida Keys. It is a analyzes four alternatives (no-action and N of the CCP). The CCP will guide us haven for over 250 species of birds, three action alternatives) that look at in managing and administering the including 10 wading-bird species that different ways of protecting resources, Lower Florida Keys Refuges for the next 15 years. nest in the refuge. Other notable providing appropriate visitor imperiled species include sea turtles. ADDRESSES: You may obtain a copy of experiences, and addressing joint NPS/ More loggerhead and green sea turtle the CCP by writing to: Ms. Anne Forest Service operations: nests are found each year in Key West Morkill, Refuge Manager, Florida Keys NWR than in any area of the Florida —Alternative 1 (No-Action) would National Wildlife Refuge Complex, Keys except the Dry Tortugas. Waters continue the present management 28590 Watson Boulevard, Big Pine Key, within the refuge’s administrative direction. FL 33043. You may also access and boundaries are important download the document from the —Alternative 2 would emphasize and developmental habitat for these sea Service’s Web site: http:// expand high-quality visitor services turtle species, as well as hawksbills and southeast.fws.gov/planning. and experiences by providing more Kemp’s ridley sea turtles. In 1975, comprehensive interpretation of the FOR FURTHER INFORMATION CONTACT: Ms. Public Law 93–632 designated all Gila Headwaters area and its 2,000 Anne Morkill; telephone: 305/872–2239; islands in Key West NWR, except years of human occupation. or Mary Morris, Natural Resource Ballast Key, which is privately owned, Planner; telephone 850/567–6202. —Alternative 3 would enhance visitor as a part of the National Wilderness understanding and enjoyment of the SUPPLEMENTARY INFORMATION: Preservation System. These islands total Gila Headwaters’ natural and cultural Introduction 2,109 acres. heritage by providing a more unified With this notice, we finalize the CCP Great White Heron NWR management approach to the two process for the Lower Florida Keys Great White Heron NWR was units of the monument. Refuges. We started this process through established in 1938, by Executive Order —Alternative 4 would forge more a notice in the Federal Register on May 7993 signed by President Roosevelt, as personal connections between visitors 9, 2003 (68 FR 25058). a haven for great white herons, and the ancient cultures and The Lower Florida Keys Refuges migratory birds, and other wildlife. The wilderness character of the includes three wildlife refuges—Key refuge encompasses 117,683 acres of monument. West National Wildlife Refuge (Key land and water with 6,300 acres of land, West NWR), Great White Heron including 1,900 land acres which were Dated: November 12, 2009. National Wildlife Refuge (Great White designated Wilderness Areas in 1975, Michael D. Snyder, Heron NWR), and National Key Deer also under Public Law 93–632. While Director, Intermountain Region, National Refuge in Monroe County, Florida. the islands are primarily mangroves, Park Service. These are a collection of low-lying, some of the larger islands contain pine [FR Doc. 2010–443 Filed 1–12–10; 8:45 am] subtropical islands between the Gulf of rockland and tropical hardwood BILLING CODE 4312–FA–P Mexico and the Atlantic Ocean that hammock habitats. This vast area, protect all the vital habitats known locally as the ‘‘backcountry,’’ representative of the Florida Keys provides critical nesting, feeding, and ecosystem, including the globally resting areas for more than 250 species imperiled pine rockland and tropical of birds. We co-manage this area with hardwood hammock. These geologically the State through a ‘‘Management and climatically distinct islands provide Agreement for Submerged Lands Within

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the Boundaries of Key West and Great whole. Each of the three refuges has with other agencies for non-refuge lands White Heron National Wildlife Refuges’’ different enabling legislation and that support the refuges’ missions. (hereinafter referred to as Management purposes. The CCP has been designed Partnerships exist to promote land Agreement). with consideration of the distinct conservation. Exotic plant control to Great white herons are a white color- purposes of each refuge. For the protect and maintain current habitat phase of great blue herons. In the United purposes of each refuge, refer to a notice would occur at existing levels by relying States, nesting is restricted to extreme in the Federal Register dated May 23, on partnerships with the Nature south Florida including the Florida 2008 (73 FR 30139). Conservancy, the Florida Fish and Keys. The refuge was created to protect Wildlife Conservation Commission, and Alternatives, Including the Preferred great white herons from extinction since Monroe County. A predator Alternative the population was decimated by the management program is currently under demand for feathered hats. Protection of The Service developed three development on National Key Deer great white herons was successful, and alternatives for managing the refuges Refuge to reduce the effects of feral cat these magnificent birds can be observed over the next 15 years and chose predation on the endangered Lower feeding on tidal flats throughout the Alternative B as the preferred Keys marsh rabbit and other native refuge. The refuge islands are also used alternative. A description of the three wildlife. for nesting by 10 wading bird species, alternatives follows. Most ecologically sensitive areas and including the reddish egret, and by Alternative A—(Current Management— living resources are protected from many neotropical migratory bird No Action) disturbance or degradation through the species. use of closure areas, law enforcement, The Lower Florida Keys Refuges have and the implementation of the National Key Deer Refuge a high diversity of community types and Management Agreement. Impacts from The National Key Deer Refuge was endemic species, with many threatened, concentrated, non-wildlife-dependent established on August 22, 1957, to endangered, candidate, and other uses threaten a limited number of sites, protect and conserve Key deer and other imperiled species. The primary mission particularly islands with accessible sand wildlife resources. It comprises about of these refuges is to provide habitat for beaches. The effects of commercial 8,983 acres of land on several islands wildlife. The refuges currently have a activities and public uses (both wildlife- within the authorized approved small staff and funding source for the dependent and non-wildlife-dependent) acquisition boundary, as well as inventorying and monitoring of natural have not been fully evaluated and additional parcels located outside the resources. Much effort has been put into visitor carrying capacities have not been boundary administered by the refuge. some resources, such as Key deer and quantified. These lands host diverse habitats, most their habitat (pine rocklands), as a result We have an active volunteer program notably globally endangered tropical of cooperative partnerships with to assist in all facets of refuge hardwood hammocks and pine academic and other research management. Partnerships for these rocklands. The refuge provides habitat organizations. Certain species, such as purposes and for research are for hundreds of endemic and migratory great white herons, white-crowned encouraged and maintained. Under this species, including 21 Federally listed pigeons, and sea turtles, have been alternative, the existing level of species, such as Key deer, Lower Keys studied over time by refuge biological administrative resources (e.g., staffing, marsh rabbit, and silver rice rat. It staff. Under this alternative, these facilities and assets, funding, and contains a variety of plants endemic to studies would continue. partnerships) would be maintained. the Florida Keys. Baseline data have yet to be This means some positions may not be The refuge is an important stopping established for some protected species, filled when vacated if funds need to be point for thousands of migrating birds species suites, habitats, and cultural reallocated to meet rising costs or new each year and an important wintering resources. The effects of natural priorities. ground for many North American bird catastrophic disturbances (e.g., Alternative B—(Preferred Alternative) species. Notable species include the Hurricane Wilma in 2005) on the piping plover and peregrine falcon. The refuges’ resources have not been fully This alternative assumes a slow-to- mosaic of upland and wetland habitats assessed and the effect of climate moderate growth of refuge resources found in the Florida Keys are critical change (e.g., sea level rise) is not over the 15-year implementation period breeding and feeding grounds for birds, known. of the CCP. It proposes a proactive and and refuge land acquisition efforts strive We would protect threatened and adaptive ecosystem-management to add to the lands already protected. endangered species through a variety of approach for the enhancement of Loggerhead, green, hawksbill, and management tools, such as area wildlife populations. It will promote a Kemp’s ridley sea turtles forage in the closures, law enforcement, exotic plant natural diversity and abundance of waters surrounding the refuge, but control, etc. Working with partners, we habitats for native plants and animals, nesting is limited to refuge lands on would continue limited research and especially Keys’ endemic, trust, and Ohio Key, where a small number of monitoring of focal species, such as Key keystone imperiled species. Many of the loggerhead nests are laid annually. deer, Lower Keys marsh rabbit, and objectives and strategies are designed to There are 2,278 acres of Wilderness some migratory birds. The National Key maintain and restore native Area designated on this refuge as of Deer Refuge’s prescribed fire communities. Active management 1975 per Public Law 632. management program would continue strategies will be applied particularly with the objectives to reduce fuels and within the globally imperiled pine Refuge Purposes sustain the pine rockland ecosystem for rockland, salt marsh transition, and The purposes of the refuges come the benefit of Key deer. freshwater wetland habitats, and island from the executive orders and As funding and willing sellers are beach berm communities. We will subsequent laws Congress passed as it available, we would continue habitat initiate research and long-term established each refuge. There are also conservation through land acquisition monitoring to expand the collection of specific purposes Congress designated within the approved acquisition baseline data and measure variables of for managing the Refuge System as a boundary and through lease agreements ecosystem health. We will promote

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cooperative studies to monitor and reduce wildland fuels and restore funding of five permanent, full-time model the immediate and/or long-term desirable habitat features where employees. Daily operation of the effects of natural catastrophic events appropriate. Predictive modeling and refuges will be guided by the CCP and (e.g., hurricanes, wildfire) and global fire effects monitoring will be used on the development and implementation of climate change, particularly sea level all prescribed-fire treatments in an 19 projects and 11 step-down rise. adaptive management approach to management plans. Wilderness and Current ongoing and proposed develop site-specific burn prescriptions cultural resource protection objectives programs and efforts focus on and to determine whether objectives and strategies will be incorporated threatened, endangered, and candidate were met. We will conduct research on within the appropriate step-down species of plants and animals. The need fire behavior, fuel response, and fire management plans. The modest growth for more comprehensive inventorying history. The fire management step-down in administrative resources will be used and long-term monitoring is addressed plan will be revised and implemented for wildlife monitoring and habitat in this alternative, particularly for accordingly in conjunction with the enhancement to better serve the refuges’ priority imperiled species and their development of a habitat management purposes and the CCP’s vision. With the habitats within the refuges. The step-down plan. exception of a new Visitor Center that feasibility of managing the core We will continue exotic plant control is proposed, the existing number of population of Key deer to minimize the as an ongoing operation within the facilities will be maintained. Energy effects of over-browsing on native plants refuges to maintain native habitats and efficiency standards will be applied will be considered in accordance with prevent new infestations. Cooperative wherever feasible during facility the Endangered Species Act. efforts will be sought with private maintenance, repair, or renovation Habitat enhancement for critically property owners and homeowners projects. Existing vehicles will be imperiled species, such as the Lower associations to control seed sources replaced with alternative fuel vehicles Keys marsh rabbit and Key tree cactus, from private lands. Existing to increase fuel efficiency and reduce will occur to ensure the long-term partnerships will be reinforced to carbon emissions. sustainability of these species. increase coordinated mapping and Opportunities for land acquisition will monitoring of treated areas with known Alternative C focus more strategically on protecting infestations and ongoing control needs. This alternative assumes a moderate- environmentally sensitive habitat by Management of non-native exotic to-substantial growth of refuge resources contacting specific property owners to predators will be implemented as from internal or external sources. It determine their willingness to sell, with directed by the South Florida Multi- would more fully realize the refuges’ a particular emphasis on enhancing Species Recovery Plan for the benefit of missions and address the large number habitat connectivity and protecting threatened and endangered species. An of threatened, endangered, and marsh rabbit habitat. Off-refuge nursery early detection and rapid response candidate species along with other propagation of the Key tree cactus will program will be implemented in imperiled species and habitat types. be implemented for later translocation cooperation with Federal, State, and While Alternative C contains many of to suitable refuge habitats. Cooperative local authorities to address the the provisions to protect and restore partnerships with nurseries and increasing invasion by and potential habitats similar to Alternative B, it botanical gardens will be developed to establishment of exotic snakes, lizards, emphasizes a broader suite of priority secure seed and plant material of rare and other non-native animals in the species, assuming the addition of and endemic plant species to ensure Florida Keys. several new staff positions and genetically viable sources for future A primary focus of the visitor services increased funding. The long-term restoration needs. Research will be program, as proposed, is to enhance inventorying and monitoring plan initiated to identify causal reasons for environmental education and outreach would be expanded to cover more the marked, long-term decline in the efforts substantially to reach larger species and species suites. Additional great white heron nesting population numbers of residents, students, studies on some species would be and to evaluate the potential impacts of educators, and visitors. This alternative undertaken and additional biological sea level rise on the ecology of wading also focuses on increasing public staffing would be required. The use of birds. awareness, understanding, and support captive, off-refuge sources of some Since a primary purpose of the for the refuges’ conservation mission. It species facing potential extirpation (e.g., refuges is to provide sanctuary for places priority on wildlife-dependent Lower Keys marsh rabbit) would be nesting and migratory birds, we will uses, such as photography and wildlife explored for reintroduction after a provide greater protection from human observation. A new visitor center on natural catastrophe, such as a major disturbance, particularly at colonial U.S. Highway 1 on Big Pine Key and hurricane. In certain habitats, some nesting bird rookeries and at beach enhanced visitor facilities at existing alternative habitat management habitats in the backcountry islands. sites (e.g., Blue Hole and Watson- techniques would be studied and Additional limitations to public use Mannillo Nature Trails) are proposed. applied. Fire management efforts would may be implemented in sensitive beach Non-wildlife-dependent forms of emphasize fire suppression and the areas important for shorebirds, terns, sea recreation will be limited or restricted reduction of hazardous fuels by turtles, and butterflies. in sensitive areas and awareness efforts mechanical or manual means to protect Strategies are proposed to enhance the will be stepped-up to inform visitors private properties, and the use of biological diversity and resiliency of the about protecting wilderness areas. A prescribed fire would be reduced or fire-dependent pine rocklands and also Visitor Services step-down plan will eliminated. Under this alternative, the to enhance fire-adapted habitat features specify program details consistent with CCP anticipates shifts in the Visitor in salt marsh transition and freshwater the Service’s visitor service program Services program in order to increase wetlands that benefit priority species in standards. visitation and public use. A refuge the National Key Deer Refuge. The basic administrative and ranger position is proposed to Prescribed fire and mechanical or operational needs of the refuges have coordinate and enhance volunteerism, manual vegetation treatments will be been addressed. Essential new staffing is to foster expanded relationships with used as habitat management tools to proposed through the addition and the Friends and Volunteers of Refuges

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(FAVOR), and to establish new Comments impacts of sea level rise on wading partnerships for environmental birds, will be expanded. education and outreach programs. Notices of availability of the Draft A primary focus of the visitor services Resource protection and visitor safety Comprehensive Conservation Plan and program is to enhance environmental would be greatly enhanced through this Environmental Assessment (Draft CCP/ education and outreach efforts through alternative, with the addition of two law EA) were sent to 200 persons on the existing venues and expanded enforcement officers. This would allow mailing list and copies were made partnerships to reach a diversity of local for more patrol and enforcement of available for a 30-day public review residents, businesses, students, closures and sensitive areas protection, period as announced in the Federal educators, and visitors. This plan especially of wilderness areas or Register on May 23, 2008 (73 FR 30139). focuses on increasing public awareness, cultural resource sites. New areas of the At least 47 persons attended two public understanding, and support for the backcountry would be closed to public meetings held on the Draft CCP/EA refuges’ conservation mission. It places access to protect wildlife resources. We during the open comment period. We priority on wildlife-dependent would seek expanded management received 25 comment letters by mail or recreational uses, such as wildlife authority to regulate public and e-mail from 16 persons and 11 non- observation and photography. Non- commercial activities in nearshore governmental organizations. Comments wildlife dependent forms of recreation, waters and submerged lands under the were received from 4 government such as beach picnicking and Management Agreement. A cultural agencies and 1 Tribal government. The sunbathing, will be limited or restricted resources field investigation and Draft CCP/EA was circulated through in sensitive areas. Awareness efforts inventory would be conducted. the Florida State Clearinghouse to 8 will be expanded to inform visitors Implementation of Alternative C State, regional, and local governments. about protecting wilderness values. would also occur through the Selected Alternative The compatibility determinations for development of 11 step-down (1) Environmental education and management plans. New staffing would After considering the comments we interpretation; (2) hiking/daypacking, be proposed through the addition of 6 received, and based on the professional jogging, and walking (National Key Deer permanent, full-time employees. The judgment of the planning team, we Refuge only); (3) bicycling (National Key positions would be in addition to the 5 selected Alternative B to implement the Deer Refuge only); (4) wildlife full-time positions proposed in CCP. It promotes the enhancement of observation and photography; (5) Alternative B, for a total of 11 full-time wildlife populations by maintaining and fishing; (6) beach use (National Key positions in Alternative C. New enhancing a diversity and abundance of Deer Refuge only); (7) public use on maintenance and government housing habitats for native plants and animals, wilderness and backcountry islands; (8) facilities would be proposed along with especially imperiled species that are research and monitoring; (9) mosquito new vehicles and boats to accommodate only found in the Florida Keys. Many of management (National Key Deer Refuge the staff increases. While Alternative C the objectives and strategies are and Great White Heron NWR only); and would promote our vision for these designed to maintain and restore native (10) horseback riding (National Key refuges, the resources available to plant communities and ensure the Deer Refuge only) are available in implement it would not likely be biological integrity across the landscape. Appendix F of the CCP. forthcoming in the current economic Strategies are designed to restore and Authority environment as compared to when first maintain the fire-dependent pine proposed. rocklands and to enhance habitat This notice is published under the Background features of selected salt marsh transition authority of the National Wildlife and freshwater wetland communities Refuge System Improvement Act of The National Wildlife Refuge System 1997, Public Law 105–57. Administration Act of 1966 (16 U.S.C. that benefit priority species in the 668dd–668ee) (Administration Act), as National Key Deer Refuge. Research and Dated: August 24, 2009. amended by the National Wildlife monitoring will provide essential Patrick Leonard, Refuge System Improvement Act of information for implementing an Acting Regional Director. adaptive management approach to 1997, requires us to develop a CCP for [FR Doc. 2010–447 Filed 1–12–10; 8:45 am] strategic landscape conservation, each national wildlife refuge. The BILLING CODE 4310–55–P purpose for developing a CCP is to providing flexibility in management provide refuge managers with a 15-year strategies in order to incorporate new plan for achieving refuge purposes and information and changing DEPARTMENT OF THE INTERIOR contributing toward the mission of the environmental conditions. The CCP also National Wildlife Refuge System, provides for obtaining baseline data and National Park Service consistent with sound principles of fish monitoring indicator species to detect and wildlife management, conservation, changes in ecosystem diversity and Draft General Management Plan and legal mandates, and our policies. In integrity related to climate change. Environmental Impact Statement, New addition to outlining broad management Since a primary purpose of the River Gorge National River, WV direction on conserving wildlife and refuges is to provide sanctuary for AGENCY: National Park Service, their habitats, CCPs identify wildlife- nesting and migratory birds, protection Department of the Interior. dependent recreational opportunities from human disturbance will be ACTION: Notice of availability of the available to the public, including enhanced, particularly at colonial Draft General Management Plan and opportunities for hunting, fishing, nesting bird rookeries and at beach Environmental Impact Statement for wildlife observation, wildlife habitats in the backcountry islands of New River Gorge National River. photography, and environmental the Key West and Great White Heron education and interpretation. We will NWRs. Ongoing research to identify SUMMARY: Pursuant to the National review and update the CCP at least causal reasons for the marked, long-term Environmental Policy Act of 1969, 42 every15 years in accordance with the decline in the great white heron nesting U.S.C. 4332(2)(C), the National Park Administration Act. population, as well as studies on the Service announces the availability of the

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Draft General Management Plan and The Draft GMP/EIS evaluates http://parkplanning.nps.gov/neri. You Environmental Impact Statement (Draft potential environmental consequences may also send written comments to GMP/EIS) for New River Gorge National of implementing the five alternatives. It Superintendent Don Striker, New River River, West Virginia. Consistent with describes the affected natural, cultural, Gorge National River, 104 Main St., National Park Service laws, regulations, scenic, and socioeconomic Glen Jean, WV 25846. Before including and policies, and the purpose of the environments within and near the park your address, phone number, e-mail National River, the Draft GMP/EIS and analyzes potential impacts on park address, or other personal identifying describes and analyzes five alternatives, resources and values. Seventeen information in your comment, you including the no action alternative, to resource topics are addressed, including should be aware that your entire guide the management of the National physiography, geology, and soils; comment—including your personal River over the next 15 to 20 years. The floodplains; water quality; vegetation; identifying information—may be made alternatives incorporate various aquatic wildlife; terrestrial wildlife; publicly available at any time. While management prescriptions to ensure rare, threatened, and endangered you can ask us in your comment to protection, access and enjoyment of the species; scenic resources; archeological withhold your personal identifying park’s resources. resources; cultural landscapes; historic information from public review, we Alternative 1 is the no action structures; ethnographic resources; cannot guarantee that we will be able to alternative, which would continue regional and local economy; do so. current management and trends, with communities; visitor use and visitor FOR FURTHER INFORMATION CONTACT: Don no major changes in direction. experience; park access; and park Striker, Superintendent, New River Alternative 2 emphasizes the operations. Gorge National River, 104 Main Street, substantial differences among subareas Glen Jean, WV 25846, (304) 465–0508. DATES: The National Park Service will of the gorge, improving them to reflect SUPPLEMENTARY INFORMATION: Through their differing character, resources, and accept comments on the Draft GMP/EIS from the public for 60 days from the the Draft GMP/EIS planning process, the visitor experiences. Management actions NPS was able to develop a unified would build upon the cultural resource, date the Environmental Protection Agency publishes their Notice of approach to managing the major interpretive, and recreational changes in and adjacent to the park opportunities of the north and south Availability in the Federal Register. Public meetings will be held in Hinton, since the 1982 General Management ends of the park, while retaining a Plan was prepared, to focus on primitive and remote feeling in the Beckley, and Fayetteville, West Virginia to solicit comments on the Draft GMP/ protecting park natural, cultural, and middle of the park. scenic resources, and to identify Alternative 3 would unify the park by EIS during the public review period. opportunities to facilitate appropriate providing a north-south through park The dates, times, and locations will be forms of visitor education, hike and bike trail, enhancing existing announced on the park’s Web site at interpretation and use. Twelve related scenic roads, and building new access http://www.nps.gov/neri; on the NPS legislative mandates have been added and facilities in the middle of the park Planning, Environment, and Public since the enabling legislation was to balance opportunities for visitors Comment (PEPC) Web site at http:// signed into law in 1978, including throughout the park. parkplanning.nps.gov/neri; in local Alternative 4 recognizes river papers; and can also be obtained by several boundary changes. The most gateways and the rim to river contacting the park at (304) 465–0508. recent legislation mandates the continuation of hunting within the park. experiences that take visitors to them as ADDRESSES: The Draft GMP/EIS will be the primary access points and The Draft GMP/EIS includes a available for public review and recommendation for additional orientation venues in the park. River comment online at the NPS PEPC Web gateways would be enhanced to tell boundary changes as well as a site (http://parkplanning.nps.gov/neri), wilderness eligibility assessment for all gorge stories while providing improved and at the park’s Web site (http:// river, trail, and recreational access. The National Park Service lands and waters www.nps.gov/neri). Printed copies (in within the current park boundary. NPS and gateway communities would limited quantity) and CDs can be work cooperatively to enhance rim to requested by calling (304) 465–0508. Mary Pearson-Cooper, river experiences. Printed hardcopies can be viewed at the Acting Regional Director, Northeast Region, Alternative 5 is the National Park following locations: National Park Service. Service’s preferred alternative. New River Gorge National River— [FR Doc. 2010–444 Filed 1–12–10; 8:45 am] Alternative 5 would preserve areas for Headquarters, 104 Main Street, Glen BILLING CODE 4310–YP–P primitive recreational experiences from Jean, WV 25846. end to end of the park. Interspersed New River Gorge National River— with these primitive areas would be Canyon Rim Visitor Center, 162 Visitor DEPARTMENT OF THE INTERIOR cultural and interpretive resource focal Center Road (off US 19, north of the areas where visitors could explore New River Gorge Bridge), Lansing, WV Bureau of Land Management communities and other places that once 25862. Notice of Intent To Prepare an populated the gorge, experience the New River Gorge National River— Environmental Impact Statement for river, and enjoy a variety of recreational Sandstone Visitor Center, Meadow the Restoration Design Energy Project experiences. A north-south through park Creek Road, Sandstone, WV 25958. connector composed of improved scenic Raleigh County Public Library, 221 N. and Possible Land Use Plan roads and trails would enable visitors to Kanawha Street, Beckley, WV 25801. Amendment travel the length of the park, visit these Summers County Public Library, 201 AGENCY: Bureau of Land Management, areas, and access the backcountry. Temple Street, Hinton, WV 25951. Interior. Partnerships with gateway communities Oak Hill Public Library, 611 Main ACTION: Notice of Intent. and improved rim to river experiences Street. Oak Hill, WV 25901. would foster links to the park as a whole The preferred method to comment is SUMMARY: In compliance with the and to specific cultural and interpretive to submit comments electronically National Environmental Policy Act resource areas within the park. through the NPS PEPC Web site at (NEPA) of 1969, as amended, and the

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Federal Land Policy and Management Energy Project is to foster development of renewable energy for Act of 1976, as amended, the Bureau of environmentally responsible production consideration for inclusion in the Land Management (BLM) Arizona State of renewable energy by amending plans, Project. Examples of submitted sites Office intends to prepare an as necessary, to identify sites or areas include gravel pits, mine sites, landfills, Environmental Impact Statement (EIS) that are already disturbed or that may be isolated parcels that have been to support possible amendments to in need of some level of remediation or disturbed, and abandoned unauthorized several BLM-Arizona Resource restoration, and which may be suitable airstrips. Sites and/or areas proposed for Management Plans (RMP) to identify for siting of renewable energy projects, the Project will be analyzed according to sites and/or areas managed by the BLM as well as allocate such sites or areas for the BLM’s planning regulations at 43 that may be suitable for the this purpose. Possible plan amendments CFR part 1600, and proposed planning development of renewable energy and to may also include decisions about amendments will analyzed in the EIS. establish appropriate design criteria for acquisition, disposal, or retention of This analysis will take into such projects. By this notice, BLM- sites or areas. The BLM will establish consideration: (1) 42 proposed sites Arizona State Office is announcing the management direction for lands covering approximately 26,000 acres; (2) beginning of the scoping process to acquired for the purposes of this Project knowledge of existing and proposed solicit public comments and identify or will extend the applicable land use energy transmission options; (3) issues. plan decisions to these lands, provided concentrations of existing and proposed DATES: This notice initiates the public there are no unresolved management energy generation; (4) technical factors; scoping process for the EIS and possible issues associated with the newly and (5) environmental factors. The sites plan amendments. Comments on issues acquired lands. The environmental submitted so far include BLM- may be submitted in writing until analysis will address, at each site or administered, State, municipal, and March 1, 2010. The dates and locations area, both existing remediation needs private lands. While the BLM planning of any scoping meetings will be and any potential for renewable energy process will primarily address announced at least 15 days in advance generation, and may also identify management of those lands and interests through local media, newspapers and project design criteria to address in lands administered by the BLM, the the BLM Web site at: http:// environmental issues particular to the analysis in the EIS may be broader in www.blm.gov/az/st/en.html. In order to site or area identified. Implementation scope. Additional restoration design be included in the Draft EIS, all of the Project will help meet community concepts, which may be incorporated comments must be received prior to the energy needs, create economic into the possible design criteria close of the scoping period or 15 days opportunities, and provide good value applicable to particular sites or areas, after the last public meeting, whichever to the taxpayer for the use of public are expected to be developed through is later. We will provide additional lands. To accomplish this, some or all scoping. Suitable sites for application of opportunities for public participation of the BLM’s RMPs throughout Arizona this approach to reuse of land may also upon publication of the Draft EIS. may need to be amended. Plans that continue to be identified over time, and may be considered in this or subsequent ADDRESSES: You may submit comments may be amended include the following: planning initiatives, depending on on issues and planning criteria related the Yuma Field Office RMP—2010; the when they are identified. to the Restoration Design Energy Project Agua Fria and Bradshaw-Harquahala RMP—2010; the Arizona Strip Field The purpose of the public scoping by any of the following methods: process is to determine relevant issues • Web site: http://www.blm.gov/az/st/ Office RMP—2008; the Lake Havasu that will influence the scope of the _ Field Office RMP—2007; the Kingman en/prog/energy/arra solar.htm; environmental analysis, including • E-mail: Include your name, any Resource Area RMP—1995; the Safford alternatives, and guide the process for organization you represent, and return District RMP—1991; the Phoenix RMP— developing the EIS. At present, the BLM address in the e-mail message to: 1988; the Lower Gila South RMP—1988 has identified the following preliminary [email protected]; as amended 2005; and the Lower Gila issues: (1) Site or area suitability for • Fax: Attn: Teri Raml, (602) 417– North Management Framework Plan— renewable energy generation and scale 9454; and 1983 as amended 2005. • of possible generation; (2) site or area Mail or other delivery service: The Energy Policy Act of 2005 (Title Please be sure to include your name, proximity to the existing electrical II, Sec. 211) establishes a goal that at transmission grid and the feasibility of any organization you represent, and a least 10,000 megawatts of renewable return address to: Restoration Design integrating new electric generation energy production capacity be approved projects with the grid; (3) site or area Energy Project, Attention: Teri Raml, on public lands by 2015. Additionally, BLM-Arizona State Office, One North proximity to population and electric use Secretarial Order 3285 directs agencies (load) centers; (4) determining the Central Avenue, Suite 800, Phoenix, within the Department of the Interior to Arizona 85004–4427. appropriate renewable energy encourage the development of generation technologies for Documents pertinent to this proposal environmentally responsible renewable may be examined at the BLM-Arizona implementation on a site-by-site and/or energy generation. The Project is area-by-area basis; and (5) the possible State Office, One North Central Avenue, consistent with the Congressional Suite 800, Phoenix, Arizona 85004. need for environmental remediation of direction, Department of the Interior project sites or areas based on previous FOR FURTHER INFORMATION CONTACT: For policies, and is unique in that it offers uses and levels of disturbance and further information and/or to have your an alternative process for site selection possible contamination of the sites or name added to our mailing list, contact that includes the identification of lands areas, as well as how addressing the Teri Raml, Project Manager, telephone in need of remediation that have possible need for remediation may be (602) 417–9388; address One North renewable energy generation potential. incorporated into design criteria that Central Avenue, Suite 800, Phoenix, At the initiation of the Project, the BLM- may be applicable to projects proposed Arizona 85004; or by e-mail Arizona State Office requested _ for a particular site or area. teri [email protected]. individual field offices and members of The EIS will use existing data for the SUPPLEMENTARY INFORMATION: The the public to identify previously analysis to support the planning purpose of the Restoration Design utilized sites that might be suitable for decisions (e.g., allocation, disposal, or

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retention decisions) that may be made ACTION: Notice of meetings. comments recorded verbatim, they must as a result of this initiative. When submit them in writing. individual project proposals for SUMMARY: In accordance with the Pedro Ramos, renewable development are received, Federal Advisory Committee Act (Pub. any site-specific analysis could be tiered Superintendent, Big Cypress National L. 92–463, 86 Stat. 770, 5 U.S.C. App 1, Preserve. to the EIS for this Project to avoid 10), notice is hereby given of the [FR Doc. 2010–445 Filed 1–12–10; 8:45 am] unnecessary duplication of analysis. meetings of the Big Cypress National BILLING CODE P Authorization of the project may Preserve ORV Advisory Committee for require amendment of some or all of the 2010. BLM RMPs throughout Arizona, as DEPARTMENT OF THE INTERIOR listed above. By this notice, the BLM is DATES: The Committee will meet on the complying with requirements in 43 CFR following dates: National Park Service 1610.2(c) to notify the public of Tuesday, February 2, 2010, 3:30–8 potential amendments to land use plans, p.m. National Register of Historic Places; predicated on the findings of the EIS. If Notification of Pending Nominations Tuesday, April 20, 2010, 3:30–8 p.m. land use plan amendments are and Related Actions necessary, the BLM will integrate the Tuesday, June 22, 2010, 3:30–8 p.m. Nominations for the following land use planning process with the Tuesday, August 17, 2010, 3:30–8 properties being considered for listing NEPA process for this project. p.m. or related actions in the National The BLM will utilize and coordinate Tuesday, October 26, 2010, 3:30–8 Register were received by the National the NEPA commenting process to satisfy p.m. Park Service before December 19, 2009. the public involvement process for Pursuant to section 60.13 of 36 CFR part Section 106 of the National Historic Tuesday, December 7, 2010, 3:30–8 p.m. 60 written comments concerning the Preservation Act (16 U.S.C. 470f) as significance of these properties under provided for in 36 CFR 800.2(d)(3). ADDRESSES: All meetings will be held at the National Register criteria for Native American Tribal consultations the Big Cypress Swamp Welcome evaluation may be forwarded by United will be conducted and Tribal concerns, Center, 33000 Tamiami Trail East, States Postal Service, to the National including impacts on Indian trust assets, Ochopee, Florida. Written comments Register of Historic Places, National will be given due consideration. and requests for agenda items may be Park Service, 1849 C St., NW., 2280, Federal, State, and local agencies, along submitted electronically on the Web site Washington, DC 20240; by all other with other stakeholders that may be http://www.nps.gov/bicy/parkmgmt/orv- carriers, National Register of Historic interested or affected by the BLM’s Places, National Park Service, 1201 Eye decision on this project are invited to advisory-committee.htm. Alternatively, comments and requests may be sent to: St., NW., 8th floor, Washington, DC participate in the scoping process and, 20005; or by fax, 202–371–6447. Written if eligible, may request or be requested Superintendent, Big Cypress National Preserve, 33100 Tamiami Trail East, or faxed comments should be submitted by the BLM to participate as a by January 28, 2010. cooperating agency. Before including Ochopee, FL 34141–1000, Attn: ORV your address, phone number, e-mail Advisory Committee. Alexandra Lord, address, or other personal identifying FOR FURTHER INFORMATION CONTACT: Acting Chief, National Register of Historic information in your comment, you Pedro Ramos, Superintendent, Big Places/National Historic Landmarks Program. should be aware that your entire Cypress National Preserve, 33100 California comment—including your personal Tamiami Trail East, Ochopee, Florida Monterey County identifying information—may be made 34141–1000; 239–695–1103, or go to the publicly available at any time. While Web site http://parkplanning.nps.gov/ USS MACON (airship remains), Address Restricted, Big Sur, 09001274. you can ask us in your comment to projectHome.cfm?parkId= withhold your personal identifying 352&projectId=20437. Colorado information from public review, we Las Animas County cannot guarantee that we will be able to SUPPLEMENTARY INFORMATION: The do so. Committee was established (Federal Latuda, Frank, House, 431 W. Colorado Ave., Trinidad, 09001275. Authority: 40 CFR 1501.7 and 43 CFR Register, August 1, 2007, pp. 42108– 1610.2. 42109) pursuant to the Preserve’s 2000 Montrose County Recreational Off-road Vehicle Denver & Rio Grande Western Railroad Stock Helen Hankins, Management Plan and the Federal Car No. 5620, 82800Q 83rd Rd., Cimarron BLM Associate State Director. Advisory Committee Act of 1972 (5 Visitor Center, Curecanti National [FR Doc. 2010–404 Filed 1–12–10; 8:45 am] U.S.C. Appendix) to examine issues and Recreation Area, Cimarron, 09001276. BILLING CODE 4310–32–P make recommendations regarding the Denver & Rio Grande Western Railroad Stock management of off-road vehicles (ORVs) Car No. 5679D, 82800Q 83rd Rd., Cimarron Visitor Center, Curecanti National in the Preserve. The agendas for these Recreation Area, Cimarron, 09001277. DEPARTMENT OF THE INTERIOR meetings will be published by press release and on the http:// Florida National Park Service parkplanning.nps.gov/ Alachua County 2010 Meetings of the Big Cypress projectHome.cfm?parkId= Jones, A. Quinn, House, 1013 NW. 7th Ave., National Preserve Off-Road Vehicle 352&projectId=20437 Web site. The Gainesville, 09001278. (ORV) Advisory Committee meetings will be open to the public, and time will be reserved for public Idaho AGENCY: Department of the Interior, comment. Oral comments will be Canyon County National Park Service, ORV Advisory summarized for the record. If Hat, The, 2112 Cleveland Blvd., Caldwell, Committee. individuals wish to have their 09001279.

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Latah County York Historic District, Bounded roughly by comment, you should be aware that Bovill Opera House, (Motion Picture Theater Ellis St., Meador Ave., 1–5, and Lakeway your entire comment—including your Buildings in Idaho MPS) 412 2nd Ave., Dr., Bellingham, 09001297. personal identifying information—may Bovill, 09001280. Wisconsin be made publicly available at any time. Cox Barn, (Agricultural Properties of Latah While you can ask us in your comment Dodge County County, Idaho) 1290 American Ridge Rd., to withhold your personal identifying Kendrick, 09001281. St. Andrew’s Church, W3081 Co. Hwy Y, information from public review, we LeRoy, 09001295. Maryland cannot guarantee that we will be able to [FR Doc. 2010–431 Filed 1–12–10; 8:45 am] do so. Allegany County BILLING CODE P Klots Throwing Company Mill, 917 Gay St., Permit TE–233201 Cumberland, 09001282. Applicant: Amistad National Recreation DEPARTMENT OF THE INTERIOR New York Area, Del Rio, Texas. Applicant requests a new permit for Fish and Wildlife Service Columbia County research and recovery purposes to Hillsdale Hamlet Historic District, NY Rts. 22 [FWS–R2–ES–2009–N271; 20124–1113– conduct presence/absence surveys for & 23, Anthony, Cold Water & Maple Sts., 0000–F5] interior least tern (Sterna antillarum) Old Town & Pill Hill Rds., Hillsdale, within Texas. 09001283. Endangered and Threatened Species Permit TE–227505 Delaware County Permit Applications Main Street Historic District, Main, N. & S. AGENCY: Fish and Wildlife Service, Applicant: Thomas D. Bonn, Lockhart, Center, John Sts. & Dutchess, Park, S. Interior. Texas. Maple & Elm Aves., Millerton, 09001284. ACTION: Notice of receipt of applications; Applicant requests a new permit for Monroe County request for public comment. research and recovery purposes to conduct presence/absence surveys for Sage, Simeon, House, 69 Main St., SUMMARY: Scottsville, 09001285. The following applicants have golden-cheeked warbler (Dendroica applied for scientific research permits, chrysoparia) and black-capped vireo New York or the Fish and Wildlife Service is (Vireo atricapilla) within Texas. amending their existing permit, to Oneida County Permit TE–841353 First Methodist Episcopal Church of Rome, conduct certain activities with Applicant: Loomis Partners, Inc., 400 N. George St., Rome, 09001286. endangered species under the Endangered Species Act of 1973, as Austin, Texas. Rockland County amended (Act). The Act requires that we Applicant requests an amendment to Brook Chapel, 6th St., Hillburn, 09001287. invite public comment on these permit a current permit for research and Suffolk County applications. recovery purposes to conduct presence/ absence surveys for northern aplomado Fire Island Light Station Historic District, DATES: To ensure consideration, written falcon (Falco femoralis septentrionalis) (Light Stations of the United States MPS) comments must be received on or before Burma Rd., Fire Island, 09001288. February 12, 2010. within Texas. ADDRESSES: Puerto Rico Written comments should Permit TE–045236 be submitted to the Chief, Endangered Applicant: SWCA Inc., Albuquerque, Trujillo Alto Municipality Species Division, Ecological Services, New Mexico. Puente de Trujillo Alto, (Historic Bridges of P.O. Box 1306, Room 6034, Puerto Rico MPS) PR 181, km. 5.6, Trujillo Albuquerque, NM 87103. Documents Applicant requests an amendment to Alto, 09001289. and other information submitted with a current permit for research and recovery purposes to conduct presence/ Rhode Island these applications are available for review, subject to the requirements of absence surveys for Virgin River chub Kent County the Privacy Act and Freedom of (Gila seminuda) and woundfin Hopkins Hollow Village, Hopkins Hollow Information Act. Documents will be (Plagopterus argentissimus) within Rd., Narrow Ln., Perry Hill Rd., Coventry available for public inspection, by Arizona. and W. Greenwich, 09001290. appointment only, during normal Permit TE–232639 business hours at the U.S. Fish and Utah Applicant: Dixie Environmental Wildlife Service, 500 Gold Ave., SW., Salt Lake County Services Co., LP, Magnolia, Texas. Room 6034, Albuquerque, NM. Please Altadena Apartments, (Salt Lake City MPS) refer to the respective permit number for Applicant requests a new permit for 310 S. 300 E., Salt Lake City, 09001291. each application when submitting research and recovery purposes to Sampson Apartments, (Salt Lake City MPS) comments. conduct presence/absence surveys for 276 E. 300 S., Salt Lake City, 09001292. red-cockaded woodpecker (Picoides FOR FURTHER INFORMATION CONTACT: Utah County borealis) and white bladderpod Susan Jacobsen, Chief, Endangered (Lesquerella pallid) within Texas. Chipman, Henry & Elizabeth Parker, House, Species Division, P.O. Box 1306, 846 E. 300 N., American Fork, 09001293. Albuquerque, NM 87103; (505) 248– Permit TE–227505 Dunn-Binnall House & Farmstead, 352 N. 200 6920. E., American Fork, 09001294. Applicant: Kathleen O’Connor, SUPPLEMENTARY INFORMATION: Georgetown, Texas. Washington Applicant requests a new permit for Whatcom County Public Availability of Comments research and recovery purposes to South Hill Historic District, Bounded by Before including your address, phone conduct presence/absence surveys for Knox, 11th, State, Cedar, 17th, and number, e-mail address, or other northern aplomado falcon (Falco Highland, Bellingham, 09001296. personal identifying information in your femoralis septentrionalis) within Texas.

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Permit TE–821577 Authority: 16 U.S.C. 1531 et seq. —Minimize the burden of the collection Permittee: Arizona Game and Fish Dated: January 6, 2010. of information on those who are to Department, Phoenix, Arizona. Benjamin N. Tuggle, respond, including through the use of appropriate automated, electronic, The Service is amending Arizona Regional Director, Southwest Region, Fish Game and Fish Department’s current and Wildlife Service. mechanical, or other technological collection techniques or other forms permit for research and recovery [FR Doc. 2010–451 Filed 1–12–10; 8:45 am] of information technology, e.g., purposes for the range of activities they BILLING CODE 4310–55–P undertake; including, but not limited to, permitting electronic submission of presence/absence surveys, research, and responses. reestablishment of the following DEPARTMENT OF JUSTICE Overview of This Information species: Kanab ambersnail (Oxyloma Collection haydeni kanabensis), lesser long-nosed Office of Justice Programs; Bureau of (1) Type of information collection: bat (Leptonycteris curasoae Justice Assistance Extension of currently approved yerbabuenae), Mexican long-nosed bat [OMB Number 1121–0220] collection. (Leptonycteris nivalis), masked (2) The title of the form/collection: bobwhite (Colinus virginianus Agency Information Collection Public Safety Officers’ Educational ridgwayi), bonytail chub (Gila elegans), Activities: Proposed Collection; Assistance Gila chub (Gila intermedia), humpback Comments Requested (3) The agency form number, if any, chub (Gila cypha), Colorado and the applicable component of the pikeminnow (Ptychocheilus lucius), ACTION: 60-Day Notice of Information Department sponsoring the collection: Quitobaquito pupfish (Cyprinodon Collection Under Review; Extension of None. Bureau of Justice Assistance, eremus), Virgin River chub (Gila currently approved collection. Bureau of Office of Justice Programs, United States seminuda), woundfin (Plagopterus Justice Assistance Application Form: Department of Justice. argentissimus),Yaqui chub (Gila Public Safety Officers’ Educational (4) Affected public who will be asked purpurea), Yaqui topminnow Assistance. or required to respond, as well as a brief (Poeciliopsis occidentalis sonoriensis), abstract: California condor (Gymnogyps The Department of Justice, Office of Primary: Dependent spouses and/or californianus), northern aplomado Justice Programs, Bureau of Justice children of public safety officers who falcon (Falco femoralis septentrionalis), Assistance, will be submitting the were killed or permanently and totally thick-billed parrot (Rhynchopsitta following information collection request disabled in the line of duty. pachyrhyncha), black-footed ferret for review and clearance in accordance Abstract: BJA’s Public Safety Officers’ (Mustela nigripes), southwestern willow with the Paperwork Reduction Act of Benefits (PSOB) Office will use the flycatcher (Empidonax traillii extimus), 1995. This proposed information PSOEA application information to California least tern (Sterna antillarum collection is published to obtain confirm the eligibility of applicants to browni), jaguar (Pathera onca), comments from the public and affected receive PSOEA benefits. Eligibility is jaguarundi (Herpailurus yagouaroundi agencies. Comments are encouraged and dependent on several factors, including tolteca), ocelot (Leopardus pardalis), will be accepted for ‘‘sixty days’’ until the applicant having received or being Sonoran pronghorn (Antilocapra March 15, 2010. If you have additional eligible to receive a portion of the PSOB americana sonoriensis), desert pupfish comments, suggestions, or need a copy death benefit, or having a family (Cyprinodon macularius), Yuma clapper of the proposed information collection member who received the PSOB rail (Rallus longirostris yumanensis), instrument with instructions or disability benefit. Also considered are Sonoran tiger salamander (Ambystoma additional information, please contact the applicant’s age and the schools tigrinum stebbinsi), Mount Graham red M. Berry at 1–866–859–2687, Bureau of being attended. In addition, information squirrel (Tamiasciurus hudsonicus Justice Assistance, Office of Justice to help BJA identify an individual is grahamensis), razorback sucker Programs, U.S. Department of Justice, collected, such as Social Security (Xyrauchen texanus), Gila topminnow 810 7th Street, NW., Washington, DC number and contact numbers and e-mail (Poeciliopsis occidentalis), Hualapai 20531 or by e-mail at addresses. The changes to the Mexican vole (Microtus mexicanus [email protected]. application form have been made in an hualpaiensis), gray wolf (Canis lupus), Written comments and suggestions effort to streamline the application Kearney’s blue-star (Amsonia from the public and affected agencies process and eliminate requests for kearneyana), Arizona hedgehog cactus concerning the proposed collection of information that is either irrelevant or (Echinocereus triglochidiatus var. information are encouraged. Your already being collected by other means. arizonicus), Brady pincushion cactus comments should address one or more Others: None. (Pediocactus bradyi), Nichol’s Turk’s of the following four points: (5) An estimate of the total number of head cactus (Echinocactus —Evaluate whether the proposed respondents and the amount of time horizonthalonius var. nicholii), Peebles collection of information is necessary needed for an average respondent to Navajo cactus (Pediocactus for the proper performance of the respond is as follows: It is estimated that peeblesianus var. peeblesianus), Pima functions of the agency, including no more than 100 new respondents will pineapple cactus (Coryphantha scheeri whether the information will have apply a year. Each application takes var. robustispina), Arizona cliff-rose practical utility; approximately 20 minutes to complete. (Purshia subintegra), Canelo Hills —Evaluate the accuracy of the agency’s (6) An estimate of the total public ladies’-tresses (Spiranthes delitescens), estimate of the burden of the burden (in hours) associated with the Holmgren milk-vetch (Astragalus proposed collection of information, collection is 33 hours. Total Annual holmgreniorum), sentry milk-vetch including the validity of the Reporting Burden: 100 × 20 minutes per (Astragalus cremnophylax var. methodology and assumptions used; application = 2,000 minutes/by 60 cremnophylax), and Huachuca water —Enhance the quality, utility, and minutes per hour = 33 hours. umbel (Lilaeopsis schaffneriana var. clarity of the information to be If additional information is required, recurva). collected; and please contact, Clearance Officer,

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United States Department of Justice, (3) Enhance the quality, utility, and Policy and Planning Staff, Patrick Henry Justice Management Division, Policy clarity of the information to be Building, Suite 1600, 601 D Street, NW., and Planning Staff, Patrick Henry collected. Washington, DC 20530. Building, Suite 1600, 601 D Street, NW., (4) Minimize the burden of the Dated: January 7, 2010. collection of information on those who Washington, DC 20530. Lynn Bryant, Dated: January 7, 2010. are to respond, including through the use of appropriate automated, Department Clearance Officer, PRA, United Lynn Bryant, States Department of Justice. electronic, mechanical, or other Department Clearance Officer, PRA, United technological collection techniques or [FR Doc. 2010–409 Filed 1–12–10; 8:45 am] States Department of Justice. other forms of information technology, BILLING CODE 4410–18–P [FR Doc. 2010–408 Filed 1–12–10; 8:45 am] e.g., permitting electronic submission of BILLING CODE 4410–18–P responses. DEPARTMENT OF JUSTICE Overview of This Information Drug Enforcement Administration DEPARTMENT OF JUSTICE (1) Type of information collection: Extension of a currently approved Office of Justice Programs Importer of Controlled Substances; collection. Notice of Application (2) The title of the form/collection: [OMB Number 1121–0235] Bulletproof Vest Partnership. Pursuant to Title 21 Code of Federal (3) The agency form number, if any, Regulations 1301.34(a), this is notice Agency Information Collection and the applicable component of the that on November 6, 2009, Mallinckrodt Activities: Proposed Collection; Department sponsoring the collection: Inc., 3600 North Second Street, St. Comment Request Form Number: None, Bureau of Justice Louis, Missouri 63147, made Assistance, Office of Justice Programs, application by renewal to the Drug ACTION: 60-Day Notice of Information Department of Justice. Enforcement Administration (DEA) for Collection Under Review: Extension of (4) Affected public who will be asked registration as an importer of the basic a currently approved collection; or required to respond, as well as a brief classes of controlled substances listed in Bulletproof Vest Partnership. abstract. Primary: State, Local, or Tribal schedule II: Governments. Other: None. Abstract: The Department of Justice, Office of The Bureau of Justice Assistance (BJA) Drug Schedule Justice Programs, Bureau of Justice collects this information as part of the Assistance, will be submitting the Phenylacetone (8501) ...... II application for federal assistance following information collection request Coca Leaves (9040) ...... II process under the Bulletproof Vest for review and clearance in accordance Opium, raw (9600) ...... II Partnership (BVP) Program. The Poppy Straw Concentrate (9670) II with the Paperwork Reduction Act of purpose of this program is to help 1995. This proposed information protect the lives of law enforcement The company plans to import the collection is published to obtain officers by helping states and units of listed controlled substances for the comments from the public and affected local and tribal governments equip their manufacture of controlled substances in agencies. Comments are encouraged and officers with armor vests. An applicant bulk for distribution to its customers. will be accepted for ‘‘sixty days’’ until may request funds to help purchase one No comments, objections, or requests March 15, 2010. If you have additional vest per officer per fiscal year. Federal for any hearings will be accepted on any comments, suggestions, or need a copy payment covers up to 50 percent of each application for registration or re- of the proposed information collection jurisdiction’s total costs. BJA uses the registration to import crude opium, instrument with instructions or information collected to review, poppy straw, concentrate of poppy additional information, please contact approve, and make awards to straw or coca leaves. As explained in M. Berry at 202–353–8643 or 1–866– jurisdictions in accordance with the Correction to Notice of Application 859–2687, by e-mail at programmatic and statutory pertaining to Rhodes Technologies, 72 [email protected] or by postal requirements. FR 3417 (2007), comments and requests mail at the Bureau of Justice Assistance, (5) An estimate of the total number of for hearings on applications to import Office of Justice Programs, U.S. respondents and the amount of time narcotic raw material are not Department of Justice, 810 7th Street, estimated for an average respondent to appropriate. NW., Washington, DC 20531. respond/reply: There are approximately Any bulk manufacturer who is Written comments and suggestions 4,500 respondents who will respond presently, or is applying to be, from the public and affected agencies approximately once per year, for a total registered with DEA to manufacture concerning the proposed collection of of 4,500 responses. Each response will such basic classes of controlled information are encouraged. Your require approximately 1 hour to substances listed in schedule I or II, comments should address one or more complete. which fall under the authority of section of the following four points: (6) An estimate of the total public 1002(a)(2)(B) of the Act (21 U.S.C. (1) Evaluate whether the proposed burden (in hours) associated with the 952(a)(2)(B)) may, in the circumstances collection of information is necessary collection: The total annual public set forth in 21 U.S.C. 958(i), file for the proper performance of the burden hours for this information comments or objections to the issuance function of the agency, including collection is estimated to be 5,000 of the proposed registration and may, at whether the information will have hours: 5,000 × 60 minutes per the same time, file a written request for practical utility. application = 300,000 minutes/by 60 a hearing on such application pursuant (2) Evaluate the accuracy of the minutes per hour = 5,000 hours. to 21 CFR 1301.43 and in such form as agency’s estimate of the burden of the If additional information is required, prescribed by 21 CFR 1316.47. proposed collection of information, please contact, Lynn Bryant, Clearance Any such comments or objections including the validity of the Officer, United States Department of should be addressed, in quintuplicate, methodology and assumptions used. Justice, Justice Management Division, to the Drug Enforcement

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Administration, Office of Diversion Drug Schedule listed basic class of controlled substance Control, Federal Register Representative is consistent with the public interest at (ODL), 8701 Morrissette Drive, Alfentanil (9737) ...... II this time. DEA has investigated Chemic Springfield, VA 22152; and must be Remifentanil (9739) ...... II Laboratories to ensure that the filed no later than February 12, 2010. Sufentanil (9740) ...... II company’s registration is consistent Fentanyl (9801) ...... II This procedure is to be conducted with the public interest. The simultaneously with and independent The company plans on manufacturing investigation has included inspection of the procedures described in 21 CFR the listed controlled substances in bulk and testing of the company’s physical 1301.34(b), (c), (d), (e), and (f). As noted for sale to its customers. security systems, verification of the in a previous notice published in the No comments or objections have been company’s compliance with state and Federal Register on September 23, 1975, received. DEA has considered the local laws, and a review of the (40 FR 43745), all applicants for factors in 21 U.S.C. 823(a) and company’s background and history. registration to import a basic class of determined that the registration of Cody Therefore, pursuant to 21 U.S.C. 823, any controlled substances in schedule I Laboratories to manufacture the listed and in accordance with 21 CFR 1301.33, or II are, and will continue to be, basic classes of controlled substances is the above named company is granted required to demonstrate to the Deputy consistent with the public interest at registration as a bulk manufacturer of Assistant Administrator, Office of this time. DEA has investigated Cody the basic class of controlled substance Diversion Control, Drug Enforcement Laboratories to ensure that the listed. Administration, that the requirements company’s registration is consistent Dated: January 6, 2010. for such registration pursuant to 21 with the public interest. The Joseph T. Rannazzisi, U.S.C. 958(a); 21 U.S.C. 823(a); and 21 investigation has included inspection CFR 1301.34(b), (c), (d), (e), and (f) are Deputy Assistant Administrator, Office of and testing of the company’s physical Diversion Control, Drug Enforcement satisfied. security systems, verification of the Administration. Dated: January 6, 2010. company’s compliance with state and [FR Doc. 2010–515 Filed 1–12–10; 8:45 am] Joseph T. Rannazzisi, local laws, and a review of the BILLING CODE 4410–09–P Deputy Assistant Administrator, Office of company’s background and history. Diversion Control, Drug Enforcement Therefore, pursuant to 21 U.S.C. 823, Administration. and in accordance with 21 CFR 1301.33, DEPARTMENT OF JUSTICE [FR Doc. 2010–504 Filed 1–12–10; 8:45 am] the above named company is granted BILLING CODE 4410–09–P registration as a bulk manufacturer of Drug Enforcement Administration the basic classes of controlled substances listed. Manufacturer of Controlled Substances; Notice of Registration DEPARTMENT OF JUSTICE Dated: January 6, 2010. Joseph T. Rannazzisi, By Notice dated September 14, 2009, Drug Enforcement Administration Deputy Assistant Administrator, Office of and published in the Federal Register Manufacturer of Controlled Diversion Control, Drug Enforcement on September 18, 2009, (74 FR 47962), Substances Notice of Registration Administration. GE Healthcare, 3350 North Ridge [FR Doc. 2010–511 Filed 1–12–10; 8:45 am] Avenue, Arlington Heights, Illinois By Notice dated August 28, 2009, and BILLING CODE 4410–09–P 60004–1412, made application by published in the Federal Register on renewal to the Drug Enforcement September 8, 2009, (74 FR 46231), Cody Administration (DEA) to be registered as Laboratories, 601 Yellowstone Avenue, DEPARTMENT OF JUSTICE a bulk manufacturer of Cocaine (9041), Cody, Wyoming 82414, made a basic class of controlled substance application by renewal to the Drug Drug Enforcement Administration listed in schedule II. Enforcement Administration (DEA) to The company plans to manufacture a Manufacturer of Controlled be registered as a bulk manufacturer of radioactive product used in diagnostic Substances; Notice of Registration the basic classes of controlled imaging in the diagnosis of Parkinson’s substances listed in schedules I and II: By Notice dated August 28, 2009, and Disease and for manufacture in bulk for published in the Federal Register on investigational new drug (IND) Drug Schedule September 8, 2009, (74 FR 46231), submission and clinical trials. Chemic Laboratories, Inc., 480 Neponset No comments or objections have been Dihydromorphine (9145) ...... I Street, Building 7, Canton, received. DEA has considered the Amphetamine (1100) ...... II factors in 21 U.S.C. 823(a) and Methamphetamine (1105) ...... II Massachusetts 02021, made application Amobarbital (2125) ...... II by renewal to the Drug Enforcement determined that the registration of GE Pentobarbital (2270) ...... II Administration (DEA) to be registered as Healthcare to manufacture the listed Secobarbital (2315) ...... II a bulk manufacturer of Cocaine (9041), basic class of controlled substance is Phenylacetone (8501) ...... II a basic class of controlled substance consistent with the public interest at Cocaine (9041) ...... II listed in schedule II. this time. DEA has investigated GE Codeine (9050) ...... II The company plans to manufacture Healthcare to ensure that the company’s Dihydrocodeine (9120) ...... II small quantities of the above listed registration is consistent with the public Oxycodone (9143) ...... II controlled substance for distribution to interest. The investigation has included Hydromorphone (9150) ...... II its customers for the purpose of inspection and testing of the company’s Diphenoxylate (9170) ...... II Ecgonine (9180) ...... II research. physical security systems, verification Hydrocodone (9193) ...... II No comments or objections have been of the company’s compliance with state Meperidine (9230) ...... II received. DEA has considered the and local laws, and a review of the Methadone (9250) ...... II factors in 21 U.S.C. 823(a) and company’s background and history. Morphine (9300) ...... II determined that the registration of Therefore, pursuant to 21 U.S.C. 823, Oxymorphone (9652) ...... II Chemic Laboratories to manufacture the and in accordance with 21 CFR 1301.33,

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the above named company is granted DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE registration as a bulk manufacturer of the basic class of controlled substance Drug Enforcement Administration National Institute of Corrections listed. Manufacturer of Controlled Solicitation for a Cooperative Dated: January 6, 2010. Substances; Notice of Registration Agreement—Curriculum Development: Joseph T. Rannazzisi, Training for Correctional Industries Deputy Assistant Administrator, Office of By Notice dated August 28, 2009, and Directors Diversion Control, Drug Enforcement published in the Federal Register on Administration. AGENCY: National Institute of September 8, 2009, (74 FR 46233), Corrections, Department of Justice. [FR Doc. 2010–509 Filed 1–12–10; 8:45 am] National Center for Natural Products BILLING CODE 4410–09–P ACTION: Solicitation for a cooperative Research-NIDA MProject, University of agreement. Mississippi, 135 Coy Waller Lab SUMMARY: DEPARTMENT OF JUSTICE Complex, University, Mississippi 38677, The National Institute of made application by renewal to the Corrections’ (NIC) Transition and Drug Enforcement Administration Drug Enforcement Administration Offender Workforce Development (T/ (DEA) to be registered as a bulk OWD) and Academy Divisions are Manufacturer of Controlled manufacturer of the basic classes of seeking applications for the Substances; Notice of Registration controlled substances listed in schedule development of a competency based, I: blended modality training curriculum By Notice dated August 28, 2009 and that will provide Correctional Industries published in the Federal Register on Drug Schedule Directors with the knowledge, skills and September 8, 2009, (74 FR 46232), abilities needed to set organizational Noramco Inc., Division of Ortho McNeil, Marihuana (7360) ...... I priorities, identify strategic objectives, Inc., 500 Swedes Landing Road, Tetrahydrocannabinols (7370) ..... I create measurable goals, establish Wilmington, Delaware 19801–4417, collaborative partnerships, utilize made application by letter to the Drug The company plans to cultivate current labor market information, and Enforcement Administration (DEA) to marihuana for the National Institute on provide specialized services and programming that support the offenders’ be registered as a bulk manufacturer of Drug Abuse for research approved by Noroxymorphone (9668), a basic class of long term attachment to the labor force. the Department of Health and Human controlled substance listed in schedule DATES: Services. Applications must be received II. by 4 p.m. EST on Friday, February 12, No comments or objections have been The company plans to bulk 2010. manufacture the listed controlled received. DEA has considered the ADDRESSES: Mailed applications must be substance as a reference standard for factors in 21 U.S.C. 823(a) and sent to: Director, National Institute of distribution to its customers which are determined that the registration of Corrections, 320 First Street, NW., Room analytical laboratories. National Center for Natural Products 5007, Washington, DC 20534. Research-NIDA MProject to manufacture Applicants are encouraged to use No comments or objections have been the listed basic classes of controlled received. DEA has considered the Federal Express, UPS, or similar service substances is consistent with the public factors in 21 U.S.C. 823(a) and to ensure delivery by the due date. interest at this time. DEA has Hand delivered applications should determined that the registration of be brought to 500 First Street, NW., Noramco Inc. to manufacture the listed investigated National Center for Natural Washington, DC 20534. At the front basic class of controlled substance is Products Research-NIDA MProject to desk, dial 7–3106, extension 0 for consistent with the public interest at ensure that the company’s registration is consistent with the public interest. The pickup. this time. DEA has investigated Faxed applications will not be Noramco Inc. to ensure that the investigation has included inspection and testing of the company’s physical accepted. Electronic applications can be company’s registration is consistent submitted via http://www.grants.gov. with the public interest. The security systems, verification of the FOR FURTHER INFORMATION CONTACT: All investigation has included inspection company’s compliance with state and technical or programmatic questions and testing of the company’s physical local laws, and a review of the concerning this announcement should security systems, verification of the company’s background and history. be directed to Michael Guevara, company’s compliance with state and Therefore, pursuant to 21 U.S.C. 823, Correctional Program Specialist, local laws, and a review of the and in accordance with 21 CFR 1301.33, National Institute of Corrections. He can company’s background and history. the above named company is granted be reached by calling 303–365–4415, or Therefore, pursuant to 21 U.S.C. 823, registration as a bulk manufacturer of by e-mail at [email protected]. and in accordance with 21 CFR 1301.33, the basic classes of controlled Questions will be accepted until one the above named company is granted substances listed. week prior to the application due date. registration as a bulk manufacturer of Dated: January 6, 2010. At this time responses to the questions the basic classes of controlled will be posted on the NIC Web site. substances listed. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of SUPPLEMENTARY INFORMATION: Dated: January 6, 2010. Diversion Control, Drug Enforcement Overview: NIC is looking to develop a Joseph T. Rannazzisi, Administration. curriculum, which follows NIC’s Deputy Assistant Administrator, Office of [FR Doc. 2010–506 Filed 1–12–10; 8:45 am] Instructional Theory Into Practice (ITIP) Diversion Control, Drug Enforcement model, to be written based on BILLING CODE 4410–09–P Administration. occupational documentation that [FR Doc. 2010–508 Filed 1–12–10; 8:45 am] includes a completed DACUM BILLING CODE 4410–09–P (Developing A Curriculum) and a

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DACUM validation for the position of Dynamic Leadership; Financial Self- Funds Available: NIC is seeking the Correctional Industries Director. It is Sufficiency; Offender Workforce applicant’s best ideas regarding anticipated that the curriculum will Development; Marketing Strategies; accomplishment of the scope of work utilize blended learning formats to Staff Workforce Competencies; and the related costs for achieving the accommodate the possibility of distance Stakeholder Network; Internal and goals of this solicitation. Funds may learning. The curriculum will be piloted External Customer Satisfaction; Reentry only be used for the activities that are and changes made based upon Services; Organizational Performance; linked to the desired outcome of the evaluation of the pilot. Engaging in Legislative Processes, and project. Background: NIC has been committed Balancing Internal/External This project will be a collaborative for years to improving offender Environments. venture with NIC’s Transition & transition, workforce development, and Document Requirements: The Offender Workforce Development and correctional industries. In an effort to following are the expected document Academy Divisions. expand on the resources NIC provides requirements. Note: Publications Eligibility of Applicants: An eligible the field in these areas, a DACUM was produced under this award must follow applicant is any public or private completed for the job of Correctional the ‘‘Guidelines for Preparing and agency, educational institution, Industries Director. This was followed Submitting Manuscripts for Publication’’ organization, individual or team with by a DACUM validation. The next step as found in the General Guidelines for expertise in the described areas. is to create and pilot a training Cooperative Agreements included in the Review Considerations: Applications curriculum for this position. award package. All final publications received under this announcement will Purpose: To create and pilot a submitted for posting on the NIC Web be subjected to a 3 to 5 person NIC Peer complete training curriculum for site must meet the federal government’s Review Process. The criteria for the Correctional Industries Directors. requirement for accessibility (508 PDF evaluation of each application will be as Scope of Work: At the end of this or HTML file). All documents follows: Cooperative Agreement, a curriculum developed under this cooperative Programmatic (60%) will have been developed using NIC’s agreement must be submitted in draft Is there demonstrated knowledge of Instructional Theory Into Practice (ITIP) form to NIC for review before the final curriculum development? Is a specific model. This model can be found on products are delivered. model of curriculum development (e.g. NIC’s Web site via the following link: Application Requirements: http://www.nicic.org/pubs/1992/ ITIP) proposed? Is there demonstrated Applications should be concisely knowledge of training for leadership 010714.pdf. The curriculum will written, contain no more than 20 double include a facilitator’s manual, and executive positions? Is there spaced typed pages (exclusive of demonstrated knowledge of techniques participant’s manual, and all relevant resumes and summaries of experience), supplemental material (such as and/or interventions that successfully and reference the project by the ‘‘NIC PowerPoint slides, visual and/or audio address acquisition and retention of Opportunity Number’’ and Title in this aids, handouts, exercises, etc.). The use new knowledge, skills and abilities? announcement. The package must of blended learning tools such as a live Does the proposal include blended and include: a cover letter that identifies the web-based training environment (e.g. distance learning approaches? Are audit agency responsible for the WebEx) or supplemental on-line project goals/tasks adequately applicant’s financial accounts as well as training courses is encouraged. Clear discussed? Is there a clear statement of the audit period or fiscal year that the learning objectives will be contained in how project goals will be accomplished, applicant operates under (e.g., July 1 each lesson, and delivery modality will to include: major tasks that will lead to through June 30); a program narrative in be based on how to most efficiently and achieving the goal, the strategies to be effectively achieve these objectives. The response to the statement of work and employed, required staffing and other curriculum will have been piloted and a budget narrative explaining projected required resources? Are there any changes incorporated as necessary. A costs. The following forms must also be innovative approaches, techniques, or pre-and post-test, as well as quizzes will included: OMB Standard Form 424, design aspects proposed that will have been developed as necessary. Application for Federal Assistance; enhance the project? Consideration will be given to advance OMB Standard Form 424A, Budget Organizational (20%) work for participants, such as reading information—Non-Construction Do the skills, knowledge, and assignments or taking an online course Programs; OMB Standard Form 424B, expertise of the organization and the through NIC’s Learning Center. An Assurances—Non-Construction proposed project staff demonstrate a evaluation, to be distributed at the Programs (these forms are available at high level of competency to carry out conclusion of the training, will also http://www.grants.gov) and DOJ/NIC the tasks? Does the applicant/ have been developed. This evaluation Certification Regarding Lobbying; organization have the necessary will examine the content, processes, and Debarment, Suspension and Other experience and organizational capacity delivery of the program. The evaluation Responsibility Matters; and the Drug- to carry out all goals of the project? Are will be designed with the purpose in Free Workplace Requirements (available the proposed project management and mind of helping to revise and improve at http://www.nicic.gov/Downloads/ staffing plans realistic and sufficient to the training and curriculum. After it is PDF/certif-frm.pdf.) complete the project within the 12- Applications may be submitted in developed under this cooperative month time frame? agreement, the proposed evaluation hard copy, or electronically via http:// protocol must be submitted to NIC for www.grants.gov. If submitted in hard Project Management/Administration review and approval before use. copy, there needs to be an original and (20%) Specific Requirements: The training three copies of the full proposal Does the applicant identify reasonable curriculum will be based on a recently (program and budget narratives, objectives, milestones, and measures to established needs assessment identified application forms and assurances). The track progress? If consultants and/or through the use of a DACUM for original should have the applicant’s partnerships are proposed, is there a Correctional Industries Directors. signature in blue ink. reasonable justification for their Modules may address the following: Authority: Public Law 93–415. inclusion in the project and a clear

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structure to ensure effective research programs across the http://www.nsf.gov/bfa/dias/policy/ coordination? Is the proposed budget government. rppr/index.jsp. realistic, does it provide sufficient cost The RPPR resulted from an initiative Comments: In compliance with the detail/narrative, and does it represent of the Research Business Models (RBM) requirement of section 3506(c)(2)(A) of good value relative to the anticipated Subcommittee of the Committee on the Paperwork Reduction Act of 1995, results? Science (CoS), a committee of the the National Science Foundation is National Science and Technology publishing the following summary of a Note: NIC will NOT award a cooperative agreement to an applicant who does not have Council (NSTC). One of the RBM proposed collection for public a Dun and Bradstreet Database Universal Subcommittee’s priority areas is to comment. Interested persons are invited Number (DUNS) and is not registered in the create greater consistency in the to send comments regarding this burden Central Contractor Registry (CCR). administration of Federal research estimate or any other aspect of this awards. Given the increasing collection of information, including any A DUNS number can be received at complexity of interdisciplinary and of the following subjects: (1) The no cost by calling the dedicated toll-free interagency research, it is important for necessity and utility of the proposed DUNS number request line at 1–800– Federal agencies to manage awards in a information collection for the proper 333–0505 (if you are a sole proprietor, similar fashion. Upon implementation, performance of the agency’s functions; you would dial 1–866–705–5711 and the RPPR will be used by agencies that (2) the accuracy of the estimated select option 1). support research and research-related burden; (3) ways to enhance the quality, Registration in the CRR can be done activities for use in submission of utility, and clarity of the information to online at the CCR Web site: http:// interim progress reports. It is intended be collected; and (4) the use of www.ccr.gov. A CCR Handbook and to replace other interim performance automated collection techniques or worksheet can also be reviewed at the reporting formats currently in use by other forms of information technology to Web site. agencies. The RPPR does not change the minimize the information collection Number of Awards: One. performance reporting requirements burden. NIC Opportunity Number: 10A30. specified in 2 CFR part 215 (OMB This number should appear as a DATES: Comments must be received by Circular A–110) and the Common Rule February 12, 2010. reference line in the cover letter, where implementing OMB Circular A–102. indicated on Standard Form 424, and Each category in the RPPR is a ADDRESSES: Comments should be outside of the envelope in which the separate reporting component. Agencies addressed to Suzanne H. Plimpton, application is sent. will direct recipients to report on the Reports Clearance Officer, Division of (Catalog of Federal Domestic Assistance one mandatory component Administrative Services, National Number: 16.601. Executive Order 12372: This (‘‘Accomplishments’’), and also may Science Foundation, 4201 Wilson Blvd, project is not subject to the provisions of direct them to report on optional Arlington, VA 22230, e-mail Executive Order 12372) components, as appropriate. Within a [email protected]; telephone: (703) particular component, agencies may 292–7556; fax: (703) 292–9188. Morris L. Thigpen, Individuals who use a Director, National Institute of Corrections. direct recipients to complete only specific questions, as not all questions telecommunications device for the deaf [FR Doc. 2010–505 Filed 1–12–10; 8:45 am] within a given component may be (TDD) may call the Federal Information BILLING CODE 4410–36–P relevant to all agencies. Agencies may Relay Service (FIRS) at 1–800–877– develop an agency- or program-specific 8339, which is accessible 24 hours a component, if necessary, to meet day, 7 days a week, 365 days a year (including Federal holidays. NATIONAL SCIENCE FOUNDATION programmatic requirements, although agencies should minimize the degree to We encourage respondents to submit comments electronically to ensure Agency Information Collection which they supplement the standard timely receipt. We cannot guarantee that Activities: Comment Request components. Such agency- or program- specific requirements will require comments mailed will be received AGENCY: National Science Foundation review and clearance by OMB. before the comment closing date. Please (NSF). Agencies also may use other OMB- include ‘‘Research Performance Progress ACTION: Submission for OMB Review; approved reporting formats, such as the Reporting’’ in the subject line of the e- Comment Request and Final Notice of a Performance Progress Report (PPR), if mail message; please also include the Uniform Research Performance Progress those formats are better suited to the full body of your comments in the text Report (RPPR) format. agency’s reporting requirements, for of the message, and as an attachment. example, for research centers/institutes, Include your name, title, organization, SUMMARY: Effective with publication of clinical trials, or fellowship/training postal address, telephone number, and this Notice in the Federal Register, awards or in connection to reporting on e-mail address in your message. agencies will be able to utilize a new program performance, through FOR FURTHER INFORMATION CONTACT: For uniform format for reporting mechanisms such as the Performance information on the RPPR, contact Jean performance progress on Federally- Assessment Rating Tool. Feldman; Head, Policy Office, Division funded research projects. The Research On behalf of the RBM Subcommittee, of Institution & Support; National Performance Progress Report (RPPR) the National Science Foundation (NSF) Science Foundation; 4201 Wilson Blvd; will directly benefit award recipients by has agreed to serve as sponsor of this Arlington, VA 22230; e-mail: making it easier for them to administer new format. We anticipate this being the [email protected]; telephone: (703) 292– Federal grant and cooperative agreement final notice before the format and 8243; fax: (703) 292–9171. programs through standardization of the instructions are finalized. The general For further information on the NSTC types of information required in interim public and Federal agencies, however, RBM Subcommittee, contact Diane performance reports—thereby reducing are invited to comment on the proposed DiEuliis, at the Office of Science and their administrative effort and costs. final format during the 30 day public Technology Policy, 725 17th Street, The RPPR will also make it easier to comment period. The Government-wide NW., Washington, DC 20503; e-mail: compare the outputs, outcomes, etc. of RPPR is posted on the NSF Web site at: [email protected]; telephone: 202–

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456–6059; fax: 202–456–6027. See also The RPPR does not change the Within a particular component, agencies the RBM Subcommittee’s Web site: performance reporting requirements also may direct recipients to complete http://rbm.nih.gov. specified in 2 CFR part 215 (OMB only specific questions, as not all SUPPLEMENTARY INFORMATION: Circular A–110) and the Common Rule questions within a given component implementing OMB Circular A–102; it may be relevant to all agencies. I. Background and Purpose of Today’s merely provides additional clarification, Agencies will utilize the standard Federal Register Notice instructions, and a standard format for instructions that have been developed This project is an initiative of the collecting the information. for each category, but may provide Research Business Models (RBM) The RPPR is intended for use in additional program-specific instructions Subcommittee of the Committee on submission of interim progress reports, necessary to clarify a requirement for a Science (COS), a committee of the not for use in submission of final particular program. For example, the National Science and Technology reports, and it is intended to replace Environmental Protection Agency (EPA) Council (NSTC). The RBM other formats currently in use by is required to collect information on Subcommittee’s objectives include: agencies supporting research and environmental impacts; so EPA can • Facilitating a coordinated effort research-related activities. The RBM direct recipients to report on the across Federal agencies to address Subcommittee plans to undertake research’s benefit to the environment or policy implications arising from the development of a final Research human health under the following changing nature of scientific research; Performance Progress Report format reporting question: ‘‘How has the project and upon completion of the interim RPPR contributed to society beyond science • Examining the effects of these exercise. The RPPR addresses progress and technology?’’ changes on business models for the for the most recently completed period, Agencies may develop additional conduct of scientific research sponsored at the frequency required or designated agency- or program-specific reporting by the Federal government. by the sponsoring agency. Information, components and instructions (e.g., the The Subcommittee used public once reported, may not have to be National Institutes of Health may need comments, agency perspectives, and provided again on subsequent reports, if to collect information on clinical trials input from a series of regional public an agency has implemented an in certain types of awards); however, to meetings to identify priority areas on electronic solution for submission of maintain maximum uniformity, which it would focus its initial efforts. progress reports. However, upon agencies will be instructed to minimize In each priority area, the Subcommittee implementation, agencies may use this the degree to which they supplement is pursuing initiatives to promote, as format in either paper copy or in the standard categories. Such agency- or appropriate, common policy, electronic form. program-specific requirements will streamlining of current procedures, or The National Science Foundation require review and clearance by OMB. the identification of agencies’ and (NSF), on behalf of the National Science Agencies also may use other OMB- institutions’ ‘‘best practices.’’ As further and Technology Council’s Research approved reporting formats, such as the information about initiatives becomes Business Models Subcommittee, Performance Progress Report (PPR), if available, it will be posted at the proposed the draft RPPR for comment in those formats are better suited to the Subcommittee’s Web site at: http:// the Federal Register [Volume 72, pages agency’s reporting requirements, for rbm.nih.gov. 63629–63631, November 9, 2007]. 347 example, for research centers/institutes, One of the RBM Subcommittee’s public comments were received from a clinical trials, or fellowship/training priority areas is greater uniformity in wide variety of respondents, including awards or in connection to reporting on the form and content of performance six institutions of higher education; program performance, through reports that are required by Federal three associations of academic and mechanisms such as the Performance grants and cooperative agreements nonprofit institutions; components of Assessment Rating Tool. awarded under research programs. six Federal agencies; and one Many Federal agencies have their own individual. All comments were carefully II. Comments, Responses, and Changes forms or formats that recipients must considered in developing a final version to the Research Performance Progress use to report progress on activities of the RPPR. The majority of public Report Format supported by research awards. While comments strongly supported the The following are the comments, and agencies use different formats and overall proposal to create a government- associated responses, resulting from the different language to request wide standard RPPR, citing the November 9, 2007 Federal Register information on progress, they generally advantages of increased consistency in Notice. collect similar information. These Federal agencies’ reporting Comment: Four Federal and six variations increase the administrative requirements. A number of specific university commenters questioned the effort and costs for recipients of Federal issues were raised, and those comments process for development and awards, and make it difficult to compare and responses are summarized in implementation of the RPPR. the outputs, outcomes, etc., of research Section II. Response: When the RBM Working programs across the government. The Each category in the RPPR is a Group was initially formed in 2004, it RPPR format will increase uniformity of separate reporting component. Agencies examined existing research progress content across Federal research will direct recipients to report on the reports with the intent of standardizing agencies. one mandatory component the reporting requirements across The RBM Subcommittee reviewed (‘‘Accomplishments’’), and may also agencies. Once a draft was developed, forms and formats currently in use by direct them to report optional the RPPR Working Group requested Federal agencies for reporting components, as appropriate. Recipients comments and modified the format performance on research grants. The will not be required or expected to based on the comments. Once final, NSF reporting categories used by the NSF report on each of the questions or items (on behalf of the National Science and were selected as a starting point for listed under a particular category. They Technology Council’s Research designing a standard format, as will be advised to state ‘‘Nothing to Business Models subcommittee) will hundreds of NSF research programs Report’’ if they have nothing significant send the RPPR to OMB for clearance as have used these categories successfully. to report during the reporting period. part of the Paperwork Reduction Act

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(PRA) process. The RPPR Working Response: All electronic system The demographics being requested only Group will develop guidance and implementation comments received in pertain to the people who have directly training as part of the implementation. response to the Federal Register Notice worked on the award. This section is Comment: Nine Federal commenters will be forwarded to the Grants optional and if another institution has requested additional data elements Executive Board and the Grants regulations preventing its reporting, the associated with project budgets. Management Line of Business for award recipient may choose not to Response: Agree. A new, optional dissemination to appropriate agency provide such data. While demographic ‘‘Budget’’ section of the format was contacts for further consideration data will be used by agencies for data created. However, upon implementation, analysis and reporting, it will not be Comment: Six Federal commenters agencies may use this format in either used by agencies as part of the progress requested additional data elements to paper copy or in electronic form. report evaluation. comply with agency special reporting Comment: One Federal and five Comment: Six Federal and one requirements on things such as clinical university commenters suggested that association commenters requested a trials. agencies be able to pre-populate the clearer indication of which paid persons Response: Agree. An optional ‘‘Special report with data from the grants.gov an award recipient should report on and reporting requirements’’ section of the application. clarification of ‘person months’ in the format was added. Response: The information collected ‘‘Participants’’ section. Comment: One Federal commenter on Grants.gov and in grant applications Response: Agree. Language was added requested the addition of a data element would not be appropriate for the RPPR to the instructions. capturing changes in project/ because the information often changes Comment: Three Federal and one performance site. between application and award. university commenters proposed the use Response: Agree. A ‘‘Change of Comment: One Federal commenter of ‘‘None’’ or ‘‘Nothing to report’’ vs. primary performance site location’’ data requested the development of a standard allowing an award recipient to leave a element was added. taxonomy for types of projects. box blank. Comment: Five Federal commenters Response: Keeping an updated list Response: Agree. ‘‘Nothing to report’’ requested the inclusion of contact would be extremely time consuming is more accurate and was added. A information and signature for the and difficult. However, if an agency or blank field could represent ‘‘nothing to authorized official submitting the group develops a standardized report’’ or a spot that the awardee forgot report, as well as date of submission. taxonomy, the RPPR Working Group to fill in. Response: Agree. Data elements to will consider incorporating this Comment: Eight Federal, four capture the electronic or hard copy taxonomy in a future update to the university, and two association signature and contact information of the format. commenters expressed concern about authorized official and date of Comment: Four Federal commenters the potential burden the report might submission were added and are suggested page and word limits for create. expected to be captured as part of the report responses. Response: The burden was carefully electronic implementation solution. Response: This is a format, not a form. considered during the development of Comment: 60 Federal commenters Agencies can define page and word the RPPR. Depending on how it is requested additional data elements to limits when appropriate. implemented by each agency, the RPPR meet agency-specific requirements. Comment: 48 Federal and six may request more extensive data than Response: No change. The university commenters requested are currently collected; but both information is either already captured in clarifications regarding the type of data agencies and award recipients will the report, or the proposed data element requested and the purpose of each receive better information. As with any would go beyond the scope of the section in the instructions. standardization effort, there may be a report, potentially increasing grantee Response: Agree. The instructions short term burden increase in order to burden and confusing users. Agencies were amended to clarify the type of data produce a long-term gain. Finally, while may pursue developing agency-specific requested and the purpose of each there may be additional burden on the requirements through OMB. However, section, where necessary. first report for the project, assuming an every attempt was made to minimize the Comment: Ten Federal commenters electronic solution, the next form could need for agency-specific requirements. questioned the broad applicability and potentially be pre-populated with Comment: Seven Federal commenters order of the proposed format. information that carries over, leading to expressed concern that the format Response: The RPPR is intentionally a burden reduction. would not be adequate for an agency’s broad to create maximum flexibility, Comment: Four Federal commenters reporting requirements, especially in allowing agencies to use it for all noted apparent redundancy of data regards to reporting on PART. research and research-related programs. elements across different sections of the Response: Agencies may consider The standardized instructions were report. using the Performance Progress Report developed to ensure consistency across Response: Each section captures (PPR) in lieu of the RPPR. The PPR has agencies wherever possible. There is no different types of data. Any apparent a specific section for reporting on the prescribed order to the format because redundancy is intentional to ensure Program Assessment Rating Tool. the order will depend on which sections agencies using only a select few of the Agencies also may pursue developing an agency determines to be mandatory. optional sections capture the necessary agency-specific requirements through Comment: Four Federal and five data. OMB. association commenters questioned the Comment: One Federal commenter Comment: 29 Federal, nine university, intent of and need for the demographic questioned the need for invention, and four association commenters noted information in the ‘‘Participants’’ patent, and license information, since it the use of current agency data collection section. is already captured elsewhere by many systems and the need to develop a new, Response: The demographics agencies. electronic, web-based solution for information being requested is based on Response: The purpose of this section research performance progress government-wide standard categories is to provide the agency program officer reporting. currently in use on a variety of forms. with a record of all that has occurred

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within the reporting period, including as part of the RPPR could be requested Council’s Research Business Models patents. through the optional agency-specific Subcommittee, this proposed format Comment: 26 Federal, four university, categories. aims to reduce the burden on recipients and two association commenters Comment: Three Federal commenters currently expending time and effort on questioned the distinction between the asked for a clear definition of research— a variety of agency-specific forms. mandatory and optional sections of the which programs are considered research Under the PRA, OMB assigns a control form. or research-related programs? number to each ‘‘collection of Response: It is up to the agencies to Response: Only the information’’ that it reviews and determine which programs are research ‘‘Accomplishments’’ component of the approves for use by an agency. An RPPR format is mandatory, while the or research-related programs. Comment: Four Federal and one agency may not conduct or sponsor, and other components are for optional use at a person is not required to respond to, the discretion of the agencies. The university commenters requested language stating that the RPPR should a collection of information unless the Federal awarding agency determines collection of information displays a which categories are mandatory or not be used as the vehicle for seeking valid OMB Control Number. The PRA optional for the award recipient to prior approvals and/or fulfilling also requires agencies to estimate the complete. This should be determined as invention reporting requirements. Response: Agree. Appropriate burden for each collection of early as possible, preferably at the time language was added to the RPPR. information. It should be noted that the funding opportunity is issued. As Comment: 25 Federal, five university, information required can vary between burden estimates associated with forms and one association commenters offered currently in use range from a minimum agencies and programs, the combination suggestions regarding the development of mandatory and optional sections of 2 hours to a maximum of 16 hours, of a Final Report format. depending on the type of research provides agencies the maximum Response: These comments will be project being supported. flexibility to collect only the considered after the development and information they specifically require. implementation of the RPPR has been The following table provides the Comment: One Federal commenter completed. estimated numbers of annual progress asked whether the RPPR would be reports, hours per report, and total III. Paperwork Reduction Act required in addition to the PHS 2590. annual burden hours by agency: Response: The RPPR would replace In furtherance of the goals of the the PHS 2590. Information not collected National Science and Technology

Number of annual Number of Total annual Department/agency name progress annual burden burden hours reports hours

DHHS (including NIH) ...... 37,900 14 .862 563,275 DHS ...... 411 12 4,932 DoC/NIST ...... 100 4 400 DoC/NOAA ...... 1,105 2 2,210 DoD ...... 11,000 6 66,000 DoE ...... 16,000 5 80,000 DoEd/IES ...... 500 16 8,000 EPA ...... 150 4 600 NASA ...... 4,000 4 16,000 NEH ...... 55 2 1,100 NSF ...... 28,030 5 140,150 USDA/NIFA ...... 12,658 2 .7 34,177

Totals ...... 116,404 6 .6 916,844

IV. Final Administrative Requirements electronic format, and include an NUCLEAR REGULATORY and Future Steps anticipated implementation date. COMMISSION The final version of the uniform Dated: January 8, 2010. Research Performance Progress Report Suzanne H. Plimpton, [Docket No. 70–7016; CLI–10–04] format that incorporates the changes Reports Clearance Officer, National Science GE-Hitachi Global Laser Enrichment discussed in the preceding Sections I Foundation. LLC; (GLE Commercial Facility); Notice and II of Supplementary Information, [FR Doc. 2010–469 Filed 1–12–10; 8:45 am] of Receipt of Application for License; may be viewed at: http://www.nsf.gov/ BILLING CODE 7555–01–P Notice of Consideration of Issuance of bfa/dias/policy/rppr/index.jsp. License; Notice of Hearing and Each Federal research agency that Commission Order; and Order supports research and research-related Imposing Procedures for Access to activities must post their policy or an Sensitive Unclassified Non-Safeguards implementation plan on the NSF and Information and Safeguards RBM Web sites within nine months after Information for Contention Preparation issuance of OSTP/OMB policy direction. Each implementation plan will address whether the agency plans Commissioners: Gregory B. Jaczko, Chairman; to implement the RPPR in paper or Dale E. Klein; Kristine L. Svinicki.

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I. Receipt of Application and period to allow members of the public Electric-Hitachi Global Laser Availability of Documents to review the publicly available portions Enrichment Uranium Enrichment Notice is hereby given that the U.S. of the license application filed after June Facility, 74 FR 16237 (April 9, 2009); Nuclear Regulatory Commission (NRC 26, 2009. See 74 FR 36781 (July 24, and Extension of Public Scoping Period or the Commission) received on June 26, 2009). On August 6, 2009, the NRC staff for the Environmental Impact Statement 2009, an application from GE-Hitachi notified GLE by letter that staff had for the Proposed General Electric- Global Laser Enrichment LLC (GLE), for completed its acceptance review and Hitachi Global Laser Enrichment a license to possess and use source, had determined that the application was Facility, 74 FR 36781 (July 24, 2009). When available, the NRC staff’s SER byproduct, and special nuclear material acceptable for formal review. Copies of GLE’s application, safety and EIS (except for portions subject to and to enrich natural uranium to a analysis report, environmental report withholding from public inspection in maximum of 8 percent U–235 by a laser- and supplement to its environmental accordance with 10 CFR 2.390) will also based enrichment process. The plant, to report (except for portions subject to be placed in the PDR and in ADAMS. be known as the GLE Commercial withholding from public inspection in Copies of correspondence between the Facility (GLE–CF), would be located accordance with 10 CFR 2.390, NRC and GLE, and transcripts of approximately six miles north of the Availability of Public Records) are prehearing conferences and hearings City of Wilmington in New Hanover available for public inspection at the (except for portions subject to County, North Carolina and would have Commission’s Public Document Room withholding from public inspection in a nominal capacity of six million (PDR) at One White Flint North, 11555 accordance with 10 CFR 2.390) similarly separative work units (SWU) per year. Rockville Pike, Rockville, Maryland will be made available to the public. GLE is a Delaware limited liability 20852. These documents are also If, following the hearing, the company and is a subsidiary of majority available for review and copying using Commission is satisfied that GLE has owner and Delaware limited liability any of the following methods: (1) Enter complied with the Commission’s company GE-Hitachi Nuclear Energy the NRC’s GE Laser Enrichment Facility regulations and the requirements of this Americas LLC (GEH), which is a wholly Licensing Web site at http:// Notice and Commission Order and the owned subsidiary of GE-Hitachi Nuclear www.nrc.gov/materials/fuel-cycle-fac/ Commission finds that the application Energy Holdings LLC (GEH-Holdings). laser.html#2a; (2) enter the NRC’s satisfies the applicable standards set GEH-Holdings is a subsidiary of Agencywide Document Access and forth in 10 CFR Parts 30, 40, and 70, a majority owner GENE Holding LLC Management System (ADAMS) at single license will be issued (GENE) and minority owner Hitachi http://www.nrc.gov/reading-rm/ authorizing: (1) The construction and America, Ltd. GENE, also a Delaware adams.html, where the accession operation of the GLE–CF; and (2) the limited liability company, is wholly number for GLE’s Environmental Report receipt, possession, use, delivery, and owned by General Electric Company is ML090910573; accession number for transfer of byproduct (e.g., calibration (GE), a United States corporation the license application is ML091871003, sources), source and special nuclear incorporated in New York. Hitachi and the accession number for material at the GLE–CF. If the GLE–CF America is a wholly owned subsidiary Supplement 1 to the Environmental is licensed, prior to commencement of of Hitachi Ltd., a Japanese corporation. Report is ML092100577; (3) contact the operations the NRC will verify through GLE also has two minority owners, PDR by calling (800) 397–4209, faxing a an inspection conducted in accordance GENE and Cameco Enrichment request to (301) 415–3548, or sending a with section 193(c) of the AEA and 10 Holdings, LLC, a Delaware limited request by electronic mail to CFR 70.32(k) that the facility meets the liability company wholly owned by [email protected]. Hard copies of the construction and operation Cameco US Holdings, Inc., a Nevada documents are available from the PDR requirements of the license. The corporation, which is in turn wholly for a fee. inspection findings will be published in owned by Cameco Corporation, a As indicated above, GLE’s initial the Federal Register. Canadian corporation. GE, through its application has been accepted for II. Notice of Hearing wholly owned and majority owned docketing and formal review (ADAMS subsidiaries, has a 51% indirect interest accession number ML091960561) and, A. Pursuant to 10 CFR 70.23a and in GLE. GLE’s minority owners Hitachi accordingly, the Commission is Section 193 of the AEA, as amended by and Cameco have indirect interests of providing this notice of hearing and the Solar, Wind, Waste, and Geothermal 25% and 24%, respectively. notice of opportunity to intervene in Power Production Incentives Act of On January 13, 2009, GLE was granted GLE’s application for a license to 1990 Public Law 101–575, § 5, 104 Stat. an exemption to file its environmental construct and operate a laser 2834, 2835–36 (codified as amended at report in advance of its license enrichment facility. Pursuant to the 42 U.S.C. 2243), a hearing will be application. GLE submitted its Atomic Energy Act of 1954, as amended conducted according to the rules of environmental report on January 30, (AEA), the NRC staff will prepare a practice in 10 CFR part 2, subparts A, 2009; and on July 13, 2009, GLE safety evaluation report (SER) after C, G, and to the extent that classified submitted a supplement to its reviewing the application and make information becomes involved, Subpart environment report, GLE Environmental findings concerning the public health I. The hearing will be held under the Report Supplement 1—Early and safety and common defense and authority of sections 53, 63, 189, 191, Construction. On April 9, 2009, the NRC security. In addition, pursuant to the and 193 of the AEA. The applicant and published notice of its intent to prepare National Environmental Policy Act of the NRC staff shall be parties to the an Environmental Impact Statement 1969 (NEPA) and the Commission’s proceeding. (EIS) on the proposed action and the regulations in 10 CFR part 51, the NRC B. Pursuant to 10 CFR part 2, Subparts opportunity for public comment on the staff will complete an environmental C and G, a contested hearing shall be appropriate scope of issues to be evaluation and prepare an EIS before the conducted by an Atomic Safety and considered in the EIS. See 74 FR 16237 hearing on the issuance of a license is Licensing Board (Licensing Board) (April 9, 2009). By notice published in completed. See Notice of Intent to appointed by the Chief Administrative the Federal Register on July 24, 2009, Prepare an Environmental Impact Judge of the Atomic Safety and the NRC extended the public comment Statement for the Proposed General Licensing Board Panel. Notice as to the

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membership of the Licensing Board will intervene. Petitions for leave to contention must be one that, if proven, be published in the Federal Register at intervene shall be filed in accordance would entitle the petitioner to relief. a later date. with the provisions of 10 CFR 2.309. Those permitted to intervene become C. The matters of fact and law to be Interested persons should consult 10 parties to the proceeding, subject to any considered are whether the application CFR part 2, section 2.309, which is limitations in the order granting leave to satisfies the standards set forth in this available at the NRC’s PDR, located at intervene, and have the opportunity to Notice and Commission Order and the One White Flint North, 11555 Rockville participate fully in the conduct of the applicable standards in 10 CFR parts 30, Pike (first floor), Rockville, MD (or call hearing with respect to resolution of 40, and 70, and whether the the PDR at (800) 397–4209 or (301) 415– that person’s admitted contentions, requirements of NEPA and the NRC’s 4737). NRC regulations are also including the opportunity to present implementing regulations in 10 CFR accessible electronically from the NRC’s evidence and to submit a cross- part 51 have been met. Electronic Reading Room on the NRC examination plan for cross-examination D. If this proceeding is not a contested Web site at http://www.nrc.gov. of witnesses, consistent with NRC proceeding, as defined by 10 CFR 2.4, As required by 10 CFR 2.309, a regulations, policies, and procedures. the Licensing Board will determine the petition for leave to intervene shall set The Licensing Board will set the time following without conducting a de novo forth with particularity the interest of and place for any prehearing evaluation of the application: (1) the petitioner in the proceeding and conferences and evidentiary hearings, Whether the application and record of how that interest may be affected by the and the appropriate notices will be the proceeding contain sufficient results of the proceeding. The petition provided. information to support license issuance must provide the name, address, and Non-timely petitions for leave to and whether the NRC staff’s review of telephone number of the petitioner and intervene and contentions, amended the application has been adequate to specifically explain the reasons why petitions, and supplemental petitions support findings to be made by the intervention should be permitted with will not be entertained absent a Director of the Office of Nuclear particular reference to the following determination by the Commission, the Materials Safety and Safeguards with factors: (1) The nature of the petitioner’s Licensing Board or a Presiding Officer respect to the matters set forth in right under the AEA to be made a party that the petition should be granted paragraph C of this section; and (2) to the proceeding; (2) the nature and and/or the contentions should be whether the review conducted by the extent of the petitioner’s property, admitted based upon a balancing of the NRC staff pursuant to 10 CFR part 51 financial, or other interest in the factors specified in 10 CFR has been adequate. E. Regardless of whether the proceeding; and (3) the possible effect of 2.309(c)(1)(i)–(viii). proceeding is contested or uncontested, any order that may be entered in the B. A State, county, municipality, the Licensing Board will, in the initial proceeding on the petitioner’s interest. Federally-recognized Indian Tribe, or decision, in accordance with Subpart A A petition for leave to intervene must agencies thereof, may submit a petition of 10 CFR part 51: Determine whether also include a specification of the to the Commission to participate as a the requirements of sections 102(2)(A), contentions that the petitioner seeks to party under 10 CFR 2.309(d)(2). The (C), and (E) of NEPA and subpart A of have litigated in the hearing. For each petition should state the nature and 10 CFR part 51 have been complied contention, the petitioner must provide extent of the petitioner’s interest in the with in the proceeding; independently a specific statement of the issue of law proceeding. The petition should be consider the final balance among or fact to be raised or controverted, as submitted to the Commission by March conflicting factors contained in the well as a brief explanation of the basis 15, 2010. The petition must be filed in record of the proceeding with a view to for the contention. Additionally, the accordance with the filing instructions determining the appropriate action to be petitioner must demonstrate that the in section IV, and should meet the taken; and determine, after weighing the issue raised by each contention is requirements for petitions for leave to environmental, economic, technical, within the scope of the proceeding and intervene set forth in section III.A, and other benefits against the is material to the findings the NRC must except that State and Federally- environmental and other costs, and make to support the granting of a license recognized Indian Tribes do not need to considering reasonable alternatives, in response to GLE’s application. The address the standing requirements in 10 whether a license should be issued, petition must also include a concise CFR 2.309(d)(1) if the facility is located denied, or appropriately conditioned to statement of the alleged facts or expert within its boundaries. The entities listed protect environmental values. opinions which support the position of above could also seek to participate in F. If the proceeding becomes a the petitioner and on which the a hearing as a nonparty pursuant to 10 contested proceeding, the Licensing petitioner intends to rely at hearing, CFR 2.315(c). Board shall make findings of fact and together with references to the specific C. Any person who does not wish, or conclusions of law on admitted sources and documents on which the is not qualified, to become a party to contentions. With respect to matters set petitioner intends to rely. Finally, the this proceeding may request permission forth in paragraph C of this section, but petition must provide sufficient to make a limited appearance pursuant not covered by admitted contentions, information to show that a genuine to the provisions of 10 CFR 2.315(a). A the Licensing Board will make the dispute exists with the applicant on a person making a limited appearance determinations set forth in paragraph D material issue of law or fact, including may make an oral or written statement without conducting a de novo references to specific portions of the of position on the issues, but may not evaluation of the application. application that the petitioner disputes otherwise participate in the proceeding. and the supporting reasons for each A limited appearance may be made at III. Intervention dispute, or, if the petitioner believes any session of the hearing or at any A. By March 15, 2010, any person that the application fails to contain prehearing conference, subject to such whose interest may be affected by this information on a relevant matter as limits and conditions as may be proceeding and who wishes to required by law, the identification of imposed by the Licensing Board. participate as a party in the proceeding each failure and the supporting reasons Persons desiring to make a limited must file a written petition for leave to for the petitioner’s belief. Each appearance are requested to inform the

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Secretary of the Commission by March system time-stamps the document and a Presiding Officer. Participants are 15, 2010. sends the submitter an e-mail notice requested not to include personal confirming receipt of the document. The privacy information, such as social IV. Electronic Submissions (E-Filing) EIE system also distributes an e-mail security numbers, home addresses, or All documents filed in NRC notice that provides access to the home phone numbers in their filings, adjudicatory proceedings, including a document to the NRC Office of the unless an NRC regulation or other law petition for leave to intervene and General Counsel and any others who requires submission of such proffered contentions, any motion or have advised the Office of the Secretary information. With respect to other document filed in the proceeding that they wish to participate in the copyrighted works, except for limited prior to the submission of a petition to proceeding, so that the filer need not excerpts that serve the purpose of the intervene, and documents filed by serve the documents on those adjudicatory filings and would interested governmental entities participants separately. Therefore, constitute a Fair Use application, participating under 10 CFR 2.315(c), applicants and other participants (or participants are requested not to include must be filed in accordance with the their counsel or representative) must copyrighted materials in their NRC E-Filing rule. The E-Filing process apply for and receive a digital ID submission. requires participants to submit and certificate before a petition to intervene serve all adjudicatory documents over is filed so that they can obtain access to V. Commission Guidance the Internet or, in some cases, to mail the document via the E-Filing system. A. Licensing Board Determination of copies on electronic storage media. A person filing electronically using Contentions Participants may not submit paper the agency’s adjudicatory E-filing copies of their filings unless they seek system may seek assistance through the The Licensing Board shall issue a a waiver in accordance with the ‘‘Contact Us’’ link located on the NRC decision on the admissibility of procedures described below. Web site at http://www.nrc.gov/site- contentions no later than June 14, 2010. To comply with the procedural help/e-submittals.html or by calling the B. Novel Legal Issues requirements of E-Filing, at least ten NRC electronic filing Help Desk, which (10) days prior to the filing deadline, the is available between 8 a.m. and 8 p.m., If rulings on petitions, contention petitioner must contact the Office of the Eastern Time, Monday through Friday, admissibility, or admitted contentions, Secretary by e-mail at Hearing. excluding government holidays. The raise novel legal or policy questions, the [email protected], or by calling (301) 415– toll-free help line number is (866) 672– Commission will provide early guidance 1677, to request: (1) A digital ID 7640. A person filing electronically may and direction on the treatment and certificate, which allows the participant also seek assistance by sending an e- resolution of such issues. Accordingly, (or its counsel or representative) to mail to the NRC electronic filing Help the Commission directs the Licensing digitally sign documents and access the Desk at [email protected]. Board to promptly certify to the E–Submittal server for any proceeding Participants who believe that they Commission in accordance with 10 CFR in which it is participating; and/or (2) have a good cause for not submitting 2.319(l) and 2.323(f) all novel legal or creation of an electronic docket for the documents electronically must, in policy issues that would benefit from proceeding (even in instances in which accordance with 10 CFR 2.302(g), file an early Commission consideration should the petitioner (or its counsel or exemption request with their initial such issues arise in this proceeding. representative) already holds an NRC paper filing requesting authorization to C. Discovery Management issued digital ID certificate). Each continue to submit documents in paper petitioner will need to download the format. Such filings must be submitted (1) All parties, except the NRC staff, Workplace Forms ViewerTM to access by: (1) First class mail addressed to the shall make the mandatory disclosures the Electronic Information Exchange Office of the Secretary of the required by 10 CFR 2.704(a) and (b) (EIE), a component of the E-Filing Commission, U.S. Nuclear Regulatory within forty-five (45) days of the system. The Workplace Forms ViewerTM Commission, Washington, DC 20555– issuance of the Licensing Board order is free and is available at http:// 0001, Attention: Rulemaking and admitting contentions. www.nrc.gov/sitehelp/e-submittals/ Adjudications Staff; or (2) courier, (2) The Licensing Board, consistent install-viewer.html. Information about express mail, or expedited delivery with fairness to all parties, should applying for a digital ID certificate is service to the Office of the Secretary, narrow the issues requiring discovery available on NRC’s public Web site at Sixteenth Floor, One White Flint North, and limit discovery to no more than one http://www.nrc.gov/site-help/e- 11555 Rockville Pike, Rockville round for admitted contentions. submittals/apply-certificates.html. Maryland 20852, Attention: Rulemaking (3) All discovery against the NRC staff Once a petitioner has obtained a and Adjudications Staff. Participants shall be governed by 10 CFR 2.336(b) digital ID certificate, had a docket filing a document in this manner are and 2.709. The NRC staff shall comply created, and downloaded the EIE responsible for serving the document on with 10 CFR 2.336(b) no later than 30 viewer, it can then submit a petition for all other participants. Filing is days after the Licensing Board order leave to intervene including proffered considered complete by first-class mail admitting contentions and shall update contentions. Submissions should be in as of the time of deposit in the mail, or the information at the same time as the Portable Document Format (PDF) in by courier, express mail, or expedited issuance of the SER or the Final accordance with NRC guidance delivery service upon depositing the Environmental Impact Statement (FEIS), available on the NRC public Web site at document with the provider of the and, subsequent to the publication of http://www.nrc.gov/site-help/e- service. the SER and FEIS, as otherwise required submittals.html. A filing is considered Documents submitted in adjudicatory by the Commission’s regulations. complete at the time the filer submits its proceedings will appear in NRC’s Discovery under 10 CFR 2.709 shall not documents through EIE. To be timely, electronic hearing docket which is commence until the issuance of the an electronic filing must be submitted to available to the public at http:// particular document, i.e., SER or EIS, the EIE system no later than 11:59 p.m. ehd.nrc.gov/EHD_Proceeding/home.asp, unless the Licensing Board, in its Eastern Time on the due date. Upon unless excluded pursuant to an order of discretion, finds that commencing receipt of a transmission, the E-Filing the Commission, the Licensing Board, or discovery against the NRC staff on safety

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issues before the SER is issued, or on is intended to improve the management issuance of the final SER 1 (or one or environmental issues before the FEIS is and the timely completion of the more environmental contentions issued will expedite the hearing without proceeding and addresses hearing directed to the applicant’s adversely affecting the Staff’s ability to schedules, parties’ obligations, Environmental Report) will expedite the complete its evaluation in a timely contentions and discovery management. proceeding without adversely impacting manner. In addition, the Commission is the Staff’s ability to complete its (4) No later than 30 days before the providing the following direction for evaluations in a timely manner. commencement of the hearing at which this proceeding: (3) The Commission also believes that an issue is to be presented, all parties (1) The Commission directs the issuing a decision on the pending other than the NRC staff shall make the Licensing Board to set a schedule for the application within about two-and-one- pretrial disclosures required by 10 CFR hearing in this proceeding consistent half years may be reasonably achieved 2.704(c). with this Order that establishes, as a under the rules of practice contained in D. Hearing Schedule goal, the issuance of a final Commission 10 CFR part 2 and the enhancements In the interest of providing a fair decision on the pending application directed by this Order. We do not expect hearing, avoiding unnecessary delays in within two-and-one-half years (30 the Licensing Board to sacrifice fairness NRC’s review and hearing process, and months) from the date of this Order. and sound decision-making to expedite producing an informed adjudicatory Accordingly, the Licensing Board any hearing granted on this application. record that supports the licensing should issue its decision on either the We do expect the Licensing Board to use determination to be made in this contested or mandatory hearing, or both, the applicable techniques specified in: 1 proceeding, the Commission expects held in this matter no later than 28 ⁄2 this Order; 10 CFR 2.332, 2.333 and that both the Licensing Board and NRC months (855 days) from the date of this 2.334; and the Commission’s policy staff, as well as the applicant and other Order. Formal discovery against the statement on the conduct of parties to this proceeding, will follow Staff shall be suspended until after the adjudicatory proceedings (CLI–98–12, the applicable requirements contained Staff completes its final SER and EIS in supra) to ensure prompt and efficient in 10 CFR part 2 and guidance in the accordance with the direction provided resolution of contested issues. See also Commission’s Statement of Policy on in paragraph C(3) above. Statement of Policy on Conduct of Conduct of Adjudicatory Proceedings, (2) The evidentiary hearing with Licensing Proceedings, CLI–81–8, 13 CLI–98–12, 48 NRC 18 (1998) (63 FR respect to issues should commence NRC 452 (1981). 41872 (August 5, 1998)) to the extent promptly after completion of the final (4) If this is a contested proceeding, that such guidance is not inconsistent Staff documents (SER or EIS) unless the the Licensing Board should adopt the with specific guidance in this Order. Licensing Board, in its discretion, finds following milestones, in developing a The guidance in the Statement of Policy that starting the hearing with respect to schedule, for conclusion of significant on Conduct of Adjudicatory Proceedings one or more safety issues prior to steps in the adjudicatory proceeding.2

Within March 15, 2010 ...... Deadline for Requests for Hearing; Petitions to Intervene and Conten- tions; and Requests for Limited Participation. Within April 13, 2010 ...... Answers to Requests for Hearing; Petitions to Intervene and Request for Limited Participation. Within April 23, 2010 ...... Replies to Answers regarding Requests for Hearing; Petitions to Inter- vene and Request for Limited Participation. Within May 13, 2010 ...... Licensing Board holds Pre-hearing Conference to hear arguments on petitions to intervene and contention admissibility. Within 30 days of pre-hearing conference ...... Licensing Board issues order determining intervention. Discovery commences, except against the Staff. Within 10 days of the Licensing Board order determining intervention: Persons admitted or entities participating under 10 CFR 2.309(d) may submit a motion for reconsideration (see below, at Section VI.B).* Within 20 days of the Licensing Board order determining intervention: Persons admitted or entities participating under 10 CFR 2.309(d) may respond to any motion for reconsideration. Within 30 days of the Licensing Board decision determining interven- Staff prepares hearing file. tion: Date of issuance of final SER/EIS Staff updates hearing file. Discovery commences against the Staff. Within 20 days of the issuance of the final SER/EIS: Motions to amend contentions; motions for late-filed contentions. Within 40 days of the issuance of final SER/EIS: Completion of answers and replies to motions for amended and late- filed contentions. Completion of discovery on original contentions. Deadline for summary disposition motions on original contentions.** Within 50 days of the issuance of the final SER/EIS: Licensing Board decision on admissibility of late-filed contentions.**

1 The Commission believes that, in the evidentiary hearing with respect to safety issues environmental reviews consistent with the appropriate circumstances, allowing discovery or prior to the issuance of the final SER in cases where timeframes herein for each document. an evidentiary hearing with respect to safety-related the applicant has responded to the Staff’s ‘‘open issues to proceed before the final SER is issued will items’’ and there is an appreciable lag time until the serve to further the Commission’s objective, as issuance of the final SER, or in cases where the reflected in the Statement of Policy on Conduct of initial SER identifies only a few open items. Adjudicatory Proceedings, CLI–98–12, supra, to 2 This schedule assumes that the SER and FEIS ensure a fair, prompt, and efficient resolution of are issued essentially at the same time. If these contested issues. For example, it may be documents are not to be issued very close in time, appropriate for the Board to permit discovery the Board should adopt separate schedules but against the staff and/or the commencement of an concurrently running for the safety and

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Within 55 days of the issuance of the final SER/EIS: Licensing Board determination as to whether resolution of any motion for summary disposition will serve to expedite the proceedings. Within 65 days of the issuance of the final SER/EIS: Answers to motions for summary disposition identified by Licensing Board. Within 75 days of the issuance of the final SER/EIS: Replies to answers to motions for summary disposition. Within 80 days of the issuance of final SER/EIS: Completion of discovery on late-filed contentions. Within 105 days of the issuance of the final SER/EIS: Licensing Board decision on summary disposition motions on original contentions. Within 115 days of the issuance of final SER/EIS: Direct testimony filed on original contentions and any amended or ad- mitted late-filed contentions. Within 125 days of the issuance of final SER/EIS: Cross-examination plans filed on original contentions and any amend- ed or admitted late-filed contentions. Within 135 days of the issuance of final SER/EIS: Evidentiary hearing begins on original contentions and any amended or admitted late-filed contentions. Within 160 days of the issuance of final SER/EIS: Completion of evidentiary hearing on remaining contentions and any amended or admitted late-filed contentions. Within 205 days of the issuance of final SER/EIS: Completion of findings and replies. Within 245 days of the issuance of final SER/EIS: Licensing Board’s initial decision.*** * Motions for reconsideration do not stay this schedule. ** No summary disposition motions on late-filed contentions are contemplated. *** The Licensing Board’s initial decision with respect to either a contested adjudicatory hearing or an uncontested, mandatory hearing should be issued no later than 281⁄2 months from the date of this Order.

To avoid unnecessary delays in the E. Commission Oversight With respect to these regulations, the proceeding, the Licensing Board should Commission notes that this is the fifth not routinely grant requests for As in any proceeding, the proceeding involving the licensing of an extensions of time and should manage Commission retains its inherent enrichment facility. The Commission the schedule such that the overall supervisory authority over the issued a number of decisions in earlier hearing process is completed within proceeding to provide additional proceedings regarding proposed sites in guidance to the Licensing Board and 281⁄2 months. Although summary Homer, Louisiana (Claiborne disposition motions are included in the participants and to resolve any matter in Enrichment Center); Eunice, New schedule above, the Licensing Board controversy itself. Mexico (National Enrichment Facility); shall not entertain motions for summary VI. Applicable Requirements and Piketon, Ohio (American Centrifuge disposition under 10 CFR 2.710, unless Plant). These final decisions—Louisiana the Licensing Board finds that such A. Licensing Energy Services (Claiborne Enrichment motions, if granted, are likely to The Commission will license and Center), CLI–92–7, 35 NRC 93 (1992); expedite the proceeding. Unless regulate byproduct, source, and special Louisiana Energy Services (Claiborne otherwise justified, the Licensing Board nuclear material at the GLE–CF in Enrichment Center), CLI–97–15, 46 NRC shall provide for the simultaneous filing accordance with the Atomic Energy Act 294 (1997); Louisiana Energy Services of answers to proposed contentions, of 1954, as amended. Section 274c.(1) of (Claiborne Enrichment Center), CLI–98– responsive pleadings, proposed findings the AEA was amended by Public Law 3, 47 NRC 77 (1998); Louisiana Energy of fact, and other similar submittals. 102–486 (October 24, 1992) to require Services (National Enrichment Facility), (5) Parties are obligated to comply the Commission to retain authority and CLI–05–05, 61 NRC 22, 36 (2005); with applicable requirements in 10 CFR responsibility for the regulation of Louisiana Energy Services (National part 2, unless directed otherwise by this uranium enrichment facilities. Enrichment Facility), et al., CLI–05–17, Order or the Licensing Board. They are Therefore, in compliance with law, the 62 NRC 5 (2005); USEC, Inc. (American also obligated in their filings before the Commission will be the sole licensing Centrifuge Plant), CLI–07–05, 65 NRC Licensing Board and the Commission to and regulatory authority with respect to 109 (2007)—resolve a number of issues ensure that their arguments and byproduct, source, and special nuclear concerning uranium enrichment licensing and may be relied upon as assertions are supported by appropriate material for the GLE–CF and with precedent. and accurate references to legal respect to the control and use of any Consistent with the AEA, and the authority and factual basis, including, as equipment or device in connection Commission’s regulations, the appropriate, citation to the record. therewith. Commission is providing the following Failure to do so may result in material Many rules and regulations in 10 CFR direction for licensing uranium being stricken from the record or, in Chapter I are applicable to the licensing enrichment facilities: extreme circumstances, a party being of a person to receive, possess, use, dismissed from the proceeding. transfer, deliver, or process byproduct, 1. Environmental Issues (6) The Commission directs the source or special nuclear material in the (a) General: 10 CFR part 51 governs Licensing Board to inform the quantities that would be possessed at the preparation of an environmental Commission promptly, in writing, if the the GLE–CF. These include 10 CFR report and an EIS for a materials license. Licensing Board determines that any parts 19, 20, 21, 25, 30, 40, 51, 70, 71, GLE’s environmental report and the single milestone could be missed by 73, 74, 95, 140, 170, and 171 for the NRC staff’s associated EIS are to include more than 30 days. The Licensing Board licensing and regulation of byproduct, a statement on the alternatives to the must include an explanation of why the source, and special nuclear material, proposed action, including a discussion milestone cannot be met and the including requirements for notices to of the no-action alternative. measures the Licensing Board will take workers, reporting of defects, radiation (b) Treatment of depleted uranium to mitigate the failure to achieve the protection, waste disposal, hexafluoride tails: As to the treatment of milestone and restore the proceeding to decommissioning funding, and the disposition of depleted uranium the overall schedule. insurance. hexafluoride tails (depleted tails) in

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these environmental documents, unless applications for section 103 or 104b. 2008) (CG–LCP–3B), and any later GLE demonstrates a use for uranium in licenses to construct or operate versions thereof. Any person producing the depleted tails as a potential utilization or production facilities filed such information must adhere to the resource, the depleted tails will be prior to August 8, 2005. The GLE criteria in CG–IGC–1, CG–LCP–3A and considered waste. The Commission has enrichment facility, the application for CG–LCP–3B. All decisions on questions previously concluded that depleted which was filed after August 8, 2005, is of classification or declassification of uranium from an enrichment facility is subject to sections 53 and 63 of the AEA information shall be made by appropriately classified as low-level and is not a production or utilization appropriate classification officials in the radioactive waste. See Louisiana Energy facility within the meaning of section NRC and are not subject to de novo Services (National Enrichment Facility), 105. Consequently, the NRC does not review in this proceeding. CLI–05–05, 61 NRC 22, 36 (2005). An have antitrust responsibilities for GLE. 7. Access to Classified Information approach for disposition of tails that is The NRC will not entertain or consider consistent with the USEC Privatization antitrust issues in connection with the Portions of GLE’s application for a Act, such as transfer to DOE for GLE application in this proceeding. license are classified Restricted Data or disposal, constitutes a ‘‘plausible National Security Information. Persons 4. Foreign Ownership strategy’’ for disposition of the GLE needing access to those portions of the depleted tails. Id. The NRC staff may The GLE application is governed by application will be required to have the consider the Department of Energy’s sections 53 and 63 of the AEA, and, appropriate security clearance for the Final Programmatic Environmental consequently, issues of foreign level of classified information to which Impact Statement for Alternative involvement shall be determined access is required. Access requirements Strategies for the Long-Term pursuant to sections 57 and 69, not apply equally to intervenors, their Management and Use of Depleted sections 103, 104 or 193(f). Sections 57 witnesses and counsel, employees of the Uranium Hexaflouride (DOE/EIS–0269), and 69 of the AEA require, among other applicant, its witnesses and counsel, 64 FR 43358 (Aug. 10, 1999), in things, an affirmative finding by the NRC personnel, and others. Any person preparing the staff’s EIS. Alternatives for Commission that issuance of a license who believes that he or she will have a the disposition of depleted uranium for the GLE–CF will not be ‘‘inimical to need for access to classified information tails will need to be addressed in these the common defense and security.’’ The for the purpose of this licensing documents. As part of the licensing requirements of sections 57 and 69 are proceeding, including the hearing, process, GLE must also address the incorporated in 10 CFR 70.31 and 10 should immediately contact the NRC, health, safety, and security issues CFR 40.32, respectively. Division of Fuel Cycle Safety and Safeguards, Washington, DC 20555, for associated with the on-site storage of 5. Creditor Requirements depleted uranium tails pending removal information on the clearance process. of the tails from the site for disposal or Pursuant to section 184 of the AEA, Telephone calls may be made to DOE disposition. the creditor regulations in 10 CFR 50.81 Timothy C. Johnson, Senior Project shall apply to the creation of creditor Manager, Uranium Enrichment Branch, 2. Financial Qualifications interests in equipment, devices, or Fuel Facility Licensing Directorate, Review of financial qualifications for important parts thereof, capable of Division of Fuel Cycle Safety and enrichment facility license applications separating the isotopes of uranium or Safeguards, Office of Nuclear Material is governed by 10 CFR part 70. In enriching uranium in the isotope U– Safety and Safeguards. Telephone: (301) Louisiana Energy Services (Claiborne 235. In addition, the creditor regulations 492–3121. Enrichment Center), CLI–97–15, 46 NRC in 10 CFR 70.44 shall apply to the 294, 309 (1997), the Commission held creation of creditor interests in special 8. Obtaining NRC Security Facility that the 10 CFR part 70 financial nuclear material. These creditor Approval for Safeguarding Classified criteria, 10 CFR 70.22(a)(8) and regulations may be augmented by Information Received or Developed 70.23(a)(5), could be met by license conditions as necessary to allow Pursuant to 10 CFR Part 95 conditioning the LES license to require ownership arrangements (such as sale Any person who requires possession funding commitments to be in place and leaseback) not covered by 10 CFR of classified information in connection prior to construction and operation. The 50.81, provided it can be found that with the licensing proceeding may specific license condition imposed— such arrangements are not inimical to process, store, reproduce, transmit, or providing one way to satisfy the the common defense and security of the handle classified information only in a requirements of 10 CFR part 70— United States. location for which facility security required LES to have in place prior to approval has been obtained from the 6. Classified Information commencement of construction or NRC’s Division of Security Operations operation: a minimum equity All matters of classification of (NSIR), Washington, DC 20555. contribution of 30% of project costs information related to the design, Telephone calls may be made to A. from the parents and affiliates of LES construction, operation, and Lynn Silvious, Chief, Information partners prior to construction of the safeguarding of the GLE–CF shall be Security Branch. Telephone: (301) 415– associated capacity; firm funding governed by classification guidance in 2214. commitments for the remaining project ‘‘DOE Classification Guide for Isotope B. Reconsideration costs; and long term enrichment Separation by the Gas Centrifuge contracts with prices sufficient to cover Process,’’ (June 2002); Change 1 (Sept. The above guidance does not both construction and operating costs, 2005); Change 2 (May 2007) (CG–ICG– foreclose the applicant, any person including a return on investment, for 1); ‘‘Joint NRC/DOE Classification Guide admitted as a party to the hearing, or an the entire term of the contracts. for Louisiana Energy Services Gas entity participating under 10 CFR Centrifuge Plant (U),’’ Confidential RD 2.315(c) from litigating material factual 3. Antitrust Review (Jan 2008) (CG–LCP–3A); and ‘‘Joint issues necessary for resolution of Section 105 of the AEA conferred on NRC/DOE Class. Guide for Louisiana contentions in this proceeding. Persons the NRC certain antitrust Energy Services Gas Centrifuge Plant permitted to intervene and entities responsibilities with respect to Safeguards & Security (U),’’ OUO (Jan participating under 10 CFR 2.315(c) as

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of the date of the order on intervention SUNSI or SGI is necessary to respond to (a) A statement that explains each may also move the Commission to this notice may request access to SUNSI individual’s ‘‘need to know’’ the SGI, as reconsider any portion of section VI of or SGI. A ‘‘potential party’’ is any person required by 10 CFR 73.2 and 10 CFR this Notice and Commission Order who intends to participate as a party by 73.22(b)(1). Consistent with the where there is no clear Commission demonstrating standing and filing an definition of ‘‘need to know’’ as stated in precedent or unambiguously governing admissible contention under 10 CFR 10 CFR 73.2, the statement must statutes or regulations. Any motion to 2.309. Requests for access to SUNSI or explain: reconsider must be filed within 10 days SGI submitted later than 10 days after (i) Specifically why the requester after the order on intervention. The publication will not be considered believes that the information is motion must contain all technical or absent a showing of good cause for the necessary to enable the requester to other arguments to support the motion. late filing, addressing why the request proffer and/or adjudicate a specific Other persons granted intervention and could not have been filed earlier. contention in this proceeding; 4 and entities participating under 10 CFR C. The requester shall submit a letter (ii) The technical competence 2.315(c), including the applicant and requesting permission to access SUNSI, (demonstrable knowledge, skill, training the NRC staff, may respond to motions SGI, or both to the Office of the or education) of the requester to for reconsideration within 20 days of Secretary, U.S. Nuclear Regulatory effectively utilize the requested SGI to the order on intervention. Motions will Commission, Washington, DC 20555– provide the basis and specificity for a be ruled upon by the Commission. A 0001, Attention: Rulemakings and proffered contention. The technical motion for reconsideration does not stay Adjudications Staff, and provide a copy competence of a potential party or its the schedule set out above in section to the Associate General Counsel for counsel may be shown by reliance on a V.D.(4). However, if the Commission Hearings, Enforcement and qualified expert, consultant, or assistant grants a motion for reconsideration, it Administration, Office of the General who satisfies these criteria. will, as necessary, provide direction on Counsel, Washington, DC 20555–0001. (b) A completed Form SF–85, ‘‘Questionnaire for Non-Sensitive adjusting the hearing schedule. The expedited delivery or courier mail Positions’’ for each individual who address for both offices is: U.S. Nuclear VII. Notice of Intent Regarding would have access to SGI. The Regulatory Commission, 11555 Classified Information completed Form SF–85 will be used by Rockville Pike, Rockville, Maryland As noted above, a hearing on this the Office of Administration to conduct 20852. The e-mail address for the Office application will be governed by 10 CFR the background check required for of the Secretary and the Office of the part 2, Subparts A, C, G, and to the access to SGI, as required by 10 CFR General Counsel are extent classified material becomes part 2, subpart G and 10 CFR [email protected] and involved, subpart I. Subpart I requires in 73.22(b)(2), to determine the requester’s [email protected], respectively.3 accordance with 10 CFR 2.907 that the trustworthiness and reliability. For The request must include the following NRC staff file a notice of intent if, at the security reasons, Form SF–85 can only information: time of publication of Notice of Hearing, be submitted electronically through the it appears that it will be impracticable (1) A description of the licensing electronic questionnaire for for the staff to avoid the introduction of action with a citation to this Federal investigations processing (e-QIP) Web Restricted Data or National Security Register notice; site, a secure Web site that is owned and Information into a proceeding. The (2) The name and address of the operated by the Office of Personnel applicant has submitted portions of its potential party and a description of the Management. To obtain online access to application that are classified. The potential party’s particularized interest the form, the requester should contact Commission notes that, since the entire that could be harmed by the action the NRC’s Office of Administration at application may become part of the identified in C.(1); (301) 492–3524.5 record of the proceeding, the NRC staff (3) If the request is for SUNSI, the (c) A completed Form FD–258 has found it impracticable for it to avoid identity of the individual or entity (fingerprint card), signed in original ink, the introduction of Restricted Data or requesting access to SUNSI and the and submitted in accordance with 10 National Security Information into the requester’s basis for the need for the CFR 73.57(d). Copies of Form FD–258 proceeding. information in order to meaningfully may be obtained by writing the Office of participate in this adjudicatory Information Services, U.S. Nuclear VIII. Order Imposing Procedures for proceeding. In particular, the request Regulatory Commission, Washington, Access to Sensitive Unclassified Non- must explain why publicly-available DC 20555–0001, by calling (301) 415– Safeguards Information and Safeguards versions of the information requested 7232 or (301) 492–7311, or by e-mail to Information for Contention Preparation would not be sufficient to provide the [email protected]. The A. This Order contains instructions basis and specificity for a proffered fingerprint card will be used to satisfy regarding how potential parties to this contention; the requirements of 10 CFR part 2, 10 proceeding may request access to (4) If the request is for SGI, the documents containing sensitive identity of each individual who would 4 Broad SGI requests under these procedures are unclassified information (including have access to SGI if the request is unlikely to meet the standard for need to know; furthermore, staff redaction of information from Sensitive Unclassified Non-Safeguards granted, including the identity of any requested documents before their release may be Information (SUNSI) and Safeguards expert, consultant, or assistant who will appropriate to comport with this requirement. Information (SGI)). Requirements for aid the requester in evaluating the SGI. These procedures do not authorize unrestricted access to SGI are primarily set forth in In addition, the request must contain disclosure or less scrutiny of a requester’s need to know than ordinarily would be applied in 10 CFR Parts 2 and 73. Nothing in this the following information: connection with an already-admitted contention or Order is intended to conflict with the non-adjudicatory access to SGI. SGI regulations. 3 While a request for hearing or petition to 5 The requester will be asked to provide his or her B. Within 10 days after publication of intervene in this proceeding must comply with the full name, Social Security number, date and place filing requirements of the NRC’s ‘‘E-Filing Rule,’’ the of birth, telephone number, and e-mail address. this notice of hearing and opportunity to initial request to access SUNSI and/or SGI under After providing this information, the requester petition for leave to intervene, any these procedures should be submitted as described usually should be able to obtain access to the online potential party who believes access to in this paragraph. form within one business day.

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CFR 73.22(b)(1), and Section 149 of the establish standing to participate in this I. Filing of Contentions. Any Atomic Energy Act of 1954, as amended, NRC proceeding; and contentions in these proceedings that which mandates that all persons with (2) The requester has established a are based upon the information received access to SGI must be fingerprinted for legitimate need for access to SUNSI or as a result of the request made for an FBI identification and criminal need to know the SGI requested. SUNSI or SGI must be filed by the history records check; F. For requests for access to SUNSI, if requestor no later than 25 days after the (d) A check or money order payable the NRC staff determines that the requestor is granted access to that in the amount of $ 200.00 6 to the U.S. requester satisfies both E.(1) and E.(2) information. However, if more than 25 Nuclear Regulatory Commission for above, the NRC staff will notify the days remain between the date the each individual for whom the request requester in writing that access to petitioner is granted access to the for access has been submitted, and SUNSI has been granted. The written information and the deadline for filing (e) If the requester or any individual notification will contain instructions on all other contentions (as established in who will have access to SGI believes how the requester may obtain copies of the notice of hearing or opportunity for they belong to one or more of the the requested documents, and any other hearing), the petitioner may file its categories of individuals that are exempt conditions that may apply to access to SUNSI or SGI contentions by that later from the criminal history records check those documents. These conditions may deadline. and background check requirements in include, but are not limited to, the J. Review of Denials of Access. (1) If the request for access to SUNSI 10 CFR 73.59, the requester should also signing of a Non-Disclosure Agreement 7 or SGI is denied by the NRC staff either provide a statement identifying which or Affidavit, or Protective Order setting after a determination on standing and exemption the requester is invoking and forth terms and conditions to prevent requisite need, or after a determination explaining the requester’s basis for the unauthorized or inadvertent on trustworthiness and reliability, the believing that the exemption applies. disclosure of SUNSI by each individual NRC staff shall immediately notify the While processing the request, the Office who will be granted access to SUNSI. G. For requests for access to SGI, if the requestor in writing, briefly stating the of Administration, Personnel Security NRC staff determines that the requester reason or reasons for the denial. Branch, will make a final determination has satisfied both E.(1) and E.(2) above, (2) Before the Office of whether the claimed exemption applies. the Office of Administration will then Administration makes an adverse Alternatively, the requester may contact determine, based upon completion of determination regarding the proposed the Office of Administration for an the background check, whether the recipient(s) trustworthiness and evaluation of their exemption status proposed recipient is trustworthy and reliability for access to SGI, the Office prior to submitting their request. reliable, as required for access to SGI by of Administration, in accordance with Persons who are exempt from the 10 CFR 73.22(b). If the Office of 10 CFR 2.705(c)(3)(iii), must provide the background check are not required to Administration determines that the proposed recipient(s) any records that complete the SF–85 or Form FD–258; individual or individuals are were considered in the trustworthiness however, all other requirements for trustworthy and reliable, the NRC will and reliability determination, including access to SGI, including the need to promptly notify the requester in writing. those required to be provided under 10 know, are still applicable. The notification will provide the names CFR 73.57(e)(1), so that the proposed Note: Copies of documents and materials of approved individuals as well as the recipient(s) have an opportunity to required by paragraphs C.(4)(b), (c), and (d) conditions under which the SGI will be correct or explain the record. of this Order must be sent to the following provided. Those conditions may (3) The requester may challenge the address: Office of Administration, U.S. include, but not be limited to, the NRC staff’s adverse determination with Nuclear Regulatory Commission, Personnel respect to access to SUNSI by filing a Security Branch, Mail Stop TWB–05–B32M, signing of a Non-Disclosure Agreement 8 challenge within 5 days of receipt of Washington, DC 20555–0001. or Affidavit, or Protective Order by each individual who will be granted that determination with: (a) The These documents and materials access to SGI. presiding officer designated in this should not be included with the request H. Release and Storage of SGI. Prior proceeding; (b) if no presiding officer letter to the Office of the Secretary, but to providing SGI to the requester, the has been appointed, the Chief the request letter should state that the NRC staff will conduct (as necessary) an Administrative Judge, or if he or she is forms and fees have been submitted as inspection to confirm that the unavailable, another administrative required above. recipient’s information protection judge, or an administrative law judge D. To avoid delays in processing system is sufficient to satisfy the with jurisdiction pursuant to 10 CFR requests for access to SGI, the requester requirements of 10 CFR 73.22. 2.318(a); or (c) if another officer has should review all submitted materials Alternatively, recipients may opt to been designated to rule on information for completeness and accuracy view SGI at an approved SGI storage access issues, with that officer. (including legibility) before submitting location rather than establish their own (4) The requester may challenge the them to the NRC. The NRC will return SGI protection program to meet SGI NRC staff’s or Office of Administration’s incomplete packages to the sender protection requirements. adverse determination with respect to without processing. access to SGI by filing a request for E. Based on an evaluation of the 7 Any motion for Protective Order or draft Non- review in accordance with 10 CFR information submitted under paragraphs Disclosure Affidavit or Agreement for SUNSI must 2.705(c)(3)(iv). Further appeals of C.(3) or C.(4) above, as applicable, the be filed with the presiding officer or the Chief decisions under this paragraph must be Administrative Judge if the presiding officer has not made pursuant to 10 CFR 2.311. NRC staff will determine within 10 days yet been designated, within 30 days of the deadline of receipt of the request whether: for the receipt of the written access request. K. Review of Grants of Access. A party (1) There is a reasonable basis to 8 Any motion for Protective Order or draft Non- other than the requester may challenge believe the petitioner is likely to Disclosure Affidavit or Agreement for SGI must be an NRC staff determination granting filed with the presiding officer or the Chief access to SUNSI or SGI whose release Administrative Judge if the presiding officer has not 6 This fee is subject to change pursuant to the yet been designated, within 180 days of the would harm that party’s interest Office of Personnel Management’s adjustable billing deadline for the receipt of the written access independent of the proceeding. Such a rates. request. challenge must be filed with the Chief

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Administrative Judge within 5 days of inefficient and decrease confidence in highlighted when, as here, the agency the notification by the NRC staff of its our licensing process. simultaneously conducts NEPA reviews grant of access. I also believe that the numerous for similar facilities within and outside If challenges to the NRC staff milestones set forth in the order are the geographical boundaries of the determinations are filed, these unnecessary and overly prescriptive. Ninth Circuit. I believe the public is procedures give way to the normal With the milestones and deadlines disserved when they are selectively and process for litigating disputes already provided in our regulations, the arbitrarily denied information on a concerning access to information. The agency has the structure in place to matter of this importance to health and availability of interlocutory review by ensure an efficient and effective hearing safety. As a policy matter, I believe that the Commission of orders ruling on process. Importantly, those regulations the Commission’s commitment to such NRC staff determinations (whether allow the Boards flexibility in adapting transparency should no longer be granting or denying access) is governed the hearing schedule to accommodate compromised, particularly now that we by 10 CFR 2.311.9 the complexity of the issues and the know that the environmental impacts of L. The Commission expects that the circumstances unique to each terrorism can be analyzed and disclosed NRC staff and presiding officers (and adjudicatory proceeding. I believe this meaningfully to the public, while any other reviewing officers) will flexibility is important and should be appropriately protecting classified consider and resolve requests for access retained for enrichment applications. information. to SUNSI or SGI, and motions for Recent developments highlight my Lastly, I am troubled by a matter protective orders, in a timely fashion in concerns. Staff has informed the which is related to both the Areva and order to minimize any unnecessary Commission that issuance of the final GE–Hitachi applications—the prospect delays in identifying those petitioners Environmental Impact Statements (EISs) of allowing applicants to conduct who have standing and who have will be delayed at least seven months in construction activities prohibited by our propounded contentions meeting the light of information only recently regulations through issuance of specificity and basis requirements in 10 submitted by Areva concerning the need exemptions. In my view, the appropriate CFR part 2. Attachment 1 to this Order to construct additional transmission process for allowing construction summarizes the general target schedule lines. Staff explained that its aggressive activities before licensing is the one we for processing and resolving requests review schedule is predicated upon the used for reactor licensees—our under these procedures. submittal of complete information by rulemaking process. This process, It is so ordered. Areva. Therefore, any deficiency in which allows stakeholder input and, Dated at Rockville, Maryland, this 7th day Areva’s submittals, like this one, can therefore, offers transparency in our of January 2010. delay the staff’s review and, decision-making process, should not be For the Commission. consequently, the hearing schedule. circumvented by the use of exemptions Annette L. Vietti-Cook, Events which can impact schedule are which I believe should be reserved for Secretary of the Commission. inevitable and unpredictable given the circumstances unique to a specific complexity and length of these facility. Chairman Gregory B. Jaczko, Offering a adjudications. The schedule Separate Statement adjustments necessitated by these Commissioners Dale E. Klein and events are best handled by the Boards Kristine L. Svinicki, Offering a Further I support issuance of this notice and Statement order in part. As I explained in my responsible for the hearings without separate statement for the Areva notice, rigid Commission deadlines which may We support issuance of this order, in I welcome the opportunity for interested compromise the fairness or its entirety, as we did the AREVA notice members of the public to participate in thoroughness of the hearing process. of hearing. Areva Enrichment Services, our hearing process and to have their In addition, as I stated in regard to the LLC (Eagle Rock Enrichment Facility), concerns about the proposed facility Areva notice, I believe the order should CLI–09–15 (July 23, 2009). The U.S. heard. I have, however, the same state that the Commission, rather than NRC Strategic Plan recognizes that concerns with this hearing notice as I the licensing board, should preside over initiatives such as the Government expressed with regard to the Areva the mandatory hearing. Gaining Performance and Results Act challenge notice. experience in this mandatory Federal agencies to become more First, I am troubled by establishing a proceeding will aid the Commission in effective and efficient and to justify tight schedule that depends on superior handling mandatory hearings on new their budget requests with demonstrated applicant performance and therefore reactor applications. program results. The NRC must strive to may turn out to be unrealistic. For Unlike the Areva notice, this notice is become more effective and efficient in example, the schedule reduces the time silent on the question of whether the light of the increasing licensing normally allowed for applicant NEPA review should address terrorism. workload and the drive to improve responses to staff requests for additional I believe that the Commission should performance in government. With this information despite the fact that the direct the staff to consider terrorism in in mind, the NRC has formally adopted agency has no control over the its environmental review, as we did in strategic goals in the area of timeliness or quality of applicant the Areva notice. I believe that the organizational excellence, including the submittals. Establishing timelines which Commission should have a consistent, following: ‘‘NRC actions are high may not be met, even through no fault nationwide approach to NEPA and quality, efficient, timely, and realistic, of the staff, may result in unfounded should discontinue the practice of to enable the safe and beneficial use of claims that the agency’s process is addressing terrorism only for facilities radioactive materials.’’ within the jurisdiction of the Ninth The NRC has recognized, in setting its 9 Requesters should note that the filing Circuit. This practice creates a disparity strategic goals and through its requirements of the NRC’s E-Filing Rule (72 FR in the public information we provide performance and accountability 49139; August 28, 2007) apply to appeals of NRC concerning the potential impacts of a reporting, that the efficiency of the staff determinations (because they must be served on a presiding officer or the Commission, as terrorist attack on our nuclear facilities agency’s regulatory processes is applicable), but not to the initial SUNSI/SGI request based on the arbitrary criteria of important to the regulated community submitted to the NRC staff under these procedures. geographic location. This disparity is and other stakeholders, including

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Federal, State, local, and Tribal and is representative of the performance Further, we are not persuaded by the authorities and the public. The NRC has expectations the NRC should set for Chairman’s argument regarding committed itself to improving the itself. Our judgment is not altered by the consideration of terrorism under NEPA. timeliness of its application reviews Chairman’s reliance on the recently- We have considered this issue in many without compromising safety and announced events in an entirely proceedings,1 and are not prepared to security, and acknowledges that this is separate proceeding—the AREVA Eagle abandon our carefully-considered possible provided industry submits Rock enrichment facility application. decisions without sufficient complete, high-quality applications. There, NRC Staff announced a delay in justification. Fundamentally, we cannot Quoting again from the NRC Strategic issuing the final EIS as a result of agree with the Chairman’s assertion that ‘‘ Plan: While the NRC will never AREVA’s recent submission on the need our approach is at odds with the compromise safety and security for to construct additional transmission agency’s commitment to transparency. increased efficiency, the agency works lines. This is thin support at best for the to improve the efficiency of its At bottom, this ruling reflects our regulatory processes wherever possible.’’ Chairman’s unwarranted conclusion consistent position on the requirements High quality—on both the agency’s that the Commission’s deadlines ‘‘may of NEPA and their application.2 and the applicant’s parts—should be, compromise the fairness or Moreover, there is no dispute that the and is, the NRC’s goal. The proceeding thoroughness of the hearing process.’’ A agency has devoted enormous resources at issue here is no exception. We believe later date for the scheduled issuance of and effort to ensure the adequate that the schedule laid out in the order— the final EIS may delay completion of protection of public health and safety while demanding the requisite quality the hearing, but it does not necessitate from the risks of terrorism after the in licensee submittals—has been any change in the milestones since the events of September 11, 2001. Our demonstrated for similar applications, is milestones that follow the issuance of differences with Chairman Jaczko on achievable with no compromise to the the final EIS are measured from the date this issue should not obscure this fact. agency’s safety and security missions, of its issuance.

ATTACHMENT 1—GENERAL TARGET SCHEDULE FOR PROCESSING AND RESOLVING REQUESTS FOR ACCESS TO SENSITIVE UNCLASSIFIED NON-SAFEGUARDS INFORMATION AND SAFEGUARDS INFORMATION IN THIS PROCEEDING

Day Event/activity

0 ...... Publication of Federal Register notice of hearing and opportunity to petition for leave to intervene, including order with in- structions for access requests. 10 ...... Deadline for submitting requests for access to Sensitive Unclassified Non-Safeguards Information (SUNSI) and/or Safe- guards Information (SGI) with information: supporting the standing of a potential party identified by name and address; de- scribing the need for the information in order for the potential party to participate meaningfully in an adjudicatory pro- ceeding; demonstrating that access should be granted (e.g., showing technical competence for access to SGI); and, for SGI, including application fee for fingerprint/background check. 60 ...... Deadline for submitting petition for intervention containing: (i) Demonstration of standing; (ii) all contentions whose formula- tion does not require access to SUNSI and/or SGI (+25 Answers to petition for intervention; +7 petitioner/requestor reply). 20 ...... Nuclear Regulatory Commission (NRC) staff informs the requester of the staff’s determination whether the request for access provides a reasonable basis to believe standing can be established and shows (1) need for SUNSI or (2) need to know for SGI. (For SUNSI, NRC staff also informs any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information.) If NRC staff makes the finding of need for SUNSI and likelihood of standing, NRC staff begins document processing (preparation of redactions or review of redacted documents). If NRC staff makes the finding of need to know for SGI and likelihood of standing, NRC staff begins background check (including fingerprinting for a criminal history records check), information processing (preparation of redactions or review of redacted documents), and readiness inspections. 25 ...... If NRC staff finds no ‘‘need,’’ no ‘‘need to know,’’ or no likelihood of standing, the deadline for petitioner/requester to file a motion seeking a ruling to reverse the NRC staff’s denial of access; NRC staff files copy of access determination with the presiding officer (or Chief Administrative Judge or other designated officer, as appropriate). If NRC staff finds ‘‘need’’ for SUNSI, the deadline for any party to the proceeding whose interest independent of the proceeding would be harmed by the release of the information to file a motion seeking a ruling to reverse the NRC staff’s grant of access. 30 ...... Deadline for NRC staff reply to motions to reverse NRC staff determination(s). 40 ...... (Receipt +30) If NRC staff finds standing and need for SUNSI, deadline for NRC staff to complete information processing and file motion for Protective Order and draft Non-Disclosure Affidavit. Deadline for applicant/licensee to file Non-Disclosure Agreement for SUNSI. 190 ...... (Receipt +180) If NRC staff finds standing, need to know for SGI, and trustworthiness and reliability, deadline for NRC staff to file motion for Protective Order and draft Non-disclosure Affidavit (or to make a determination that the proposed recipient of SGI is not trustworthy or reliable). Note: Before the Office of Administration makes an adverse determination regarding access to SGI, the proposed recipient must be provided an opportunity to correct or explain information. 205 ...... Deadline for petitioner to seek reversal of a final adverse NRC staff trustworthiness or reliability determination either before the presiding officer or another designated officer under 10 CFR 2.705(c)(3)(iv). A ...... If access granted: Issuance of presiding officer or other designated officer decision on motion for protective order for access to sensitive information (including schedule for providing access and submission of contentions) or decision reversing a final adverse determination by the NRC staff. A + 3 ...... Deadline for filing executed Non-Disclosure Affidavits. Access provided to SUNSI and/or SGI consistent with decision issuing the protective order.

1 See, e.g., AmerGen Energy Co., LLC (Oyster 2 We have complied with the Ninth Circuit’s conducting environmental analyses of terrorist Creek Nuclear Generating Station, CLI–07–8, 65 ruling for facilities within the Ninth Circuit, as we scenarios for the licensing of all major facilities NRC 124 (2007), aff’d N.J. Dep’t of Envtl. Prot. v. are required to do. That experience, however, is would be practicable or lead to meaningful NRC, 561 F.3d 132 (3d Cir. 2009). very limited, and does not demonstrate that additional information.

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ATTACHMENT 1—GENERAL TARGET SCHEDULE FOR PROCESSING AND RESOLVING REQUESTS FOR ACCESS TO SENSITIVE UNCLASSIFIED NON-SAFEGUARDS INFORMATION AND SAFEGUARDS INFORMATION IN THIS PROCEEDING—Continued

Day Event/activity

A + 28 ...... Deadline for submission of contentions whose development depends upon access to SUNSI and/or SGI. However, if more than 25 days remain between the petitioner’s receipt of (or access to) the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI or SGI contentions by that later deadline. A + 53 ...... (Contention receipt +25) Answers to contentions whose development depends upon access to SUNSI and/or SGI. A + 60 ...... (Answer receipt +7) Petitioner/Intervenor reply to answers. >A + 60 ...... Decision on contention admission.

[FR Doc. 2010–485 Filed 1–12–10; 8:45 am] above. In addition, this guide embodies 0001. The PDR can also be reached by BILLING CODE 7590–01–P the findings by standards organizations telephone at (301) 415–4737 or (800) and agencies, such as the International 397–4205, by fax at (301) 415–3548, and Society of Automation, the Institute of by e-mail to [email protected]. NUCLEAR REGULATORY Electrical and Electronic Engineers, and Regulatory guides are not COMMISSION the National Institute of Standard and copyrighted, and Commission approval [NRC–2010–0009] Technology, as well as guidance from is not required to reproduce them. the U.S. Department of Homeland Dated at Rockville, Maryland, this 6th day Final Regulatory Guide: Issuance, Security. of January, 2010. Availability RG 5.71 provides a framework to aid For the Nuclear Regulatory Commission. in the identification of those digital Andrea D. Valentin, AGENCY: Nuclear Regulatory assets that must be protected from cyber Commission. attacks. These identified digital assets Chief, Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear ACTION: Notice of Issuance and are referred to as critical digital assets Regulatory Research. Availability of Regulatory Guide (RG) (CDAs). Licensees should address the [FR Doc. 2010–488 Filed 1–12–10; 8:45 am] 5.71, ‘‘Cyber Security Programs for potential cyber security risks of CDAs Nuclear Facilities.’’ by applying the defensive architecture BILLING CODE 7590–01–P and the collection of security controls FOR FURTHER INFORMATION CONTACT: Karl identified in this regulatory guide. NUCLEAR REGULATORY J. Sturzebecher, U.S. Nuclear Regulatory The RG 5.71 framework offers COMMISSION Commission, Washington, DC 20555– licensees and applicants the ability to 0001, telephone: (301) 251–7494 or e- address the specific needs of an existing Advisory Committee on Reactor mail [email protected]. or new system. The goal of this Safeguards (ACRS), Planning and SUPPLEMENTARY INFORMATION: regulatory guide is to harmonize the Procedures Subcommittee Meeting; well-known and well-understood set of I. Introduction Notice of Meeting security controls (based on NIST cyber The U.S. Nuclear Regulatory security standards) that address The ACRS Planning and Procedures Commission (NRC or Commission) is potential cyber risks to CDAs to provide Subcommittee will hold a meeting on issuing a new guide in the agency’s a flexible programmatic approach in February 3, 2010, Room T2–B1, 11545 ‘‘Regulatory Guide’’ series. This series which the licensee or applicant can Rockville Pike, Rockville, Maryland. was developed to describe and make establish, maintain, and successfully The entire meeting will be open to available to the public information such integrate these security controls into a public attendance, with the exception of as methods that are acceptable to the site-specific cyber security program. a portion that may be closed pursuant NRC staff for implementing specific to 5 U.S.C. 552b (c)(2) and (6) to discuss parts of the agency’s regulations, II. Further Information organizational and personnel matters techniques that the staff uses in The Agency released DG–5022, which that relate solely to the internal evaluating specific problems or contained safeguards information, personnel rules and practices of the postulated accidents, and data that the directly to stakeholders, who provided ACRS, and information the release of staff needs in its review of applications comments on July 18, 2008, December which would constitute a clearly for permits and licenses. 12, 2008, and January 14, 2009. The unwarranted invasion of personal RG 5.71, ‘‘Cyber Security Programs for responses to stakeholder’s comments are privacy. Nuclear Facilities,’’ was issued with a located in the NRC’s Agencywide The agenda for the subject meeting temporary identification as Draft Documents Access and Management shall be as follows: Regulatory Guide, DG–5022. This System under Accession Number Wednesday, February 3, 2010, 12 regulatory guide provides guidance to ML090340185. Electronic copies of RG p.m.–1 p.m. applicants and licensees on satisfying 5.71 are available through the NRC’s The Subcommittee will discuss the requirements of 10 CFR 73.54. The public Web site under ‘‘Regulatory proposed ACRS activities and related information contained within this guide Guides’’ at http://www.nrc.gov/reading- matters. The Subcommittee will gather represents the results of research rm/doc-collections/. information, analyze relevant issues and conducted by the NRC Office of Nuclear In addition, regulatory guides are facts, and formulate proposed positions Regulatory Research concerning cyber available for inspection at the NRC’s and actions, as appropriate, for security program development and the Public Document Room (PDR) located at deliberation by the full Committee. collective body of knowledge and 11555 Rockville Pike, Rockville, Members of the public desiring to experience that has been developed Maryland. The PDR’s mailing address is provide oral statements and/or written through all of the actions identified USNRC PDR, Washington, DC 20555– comments should notify the Designated

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Federal Officer (DFO), Mr. Peter Wen, regarding this matter. The ACTION: Request for resumes. (Telephone: 301–415–2832, E-mail: Subcommittee will gather information, [email protected]) five days prior to analyze relevant issues and facts, and SUMMARY: The U.S. Nuclear Regulatory the meeting, if possible, so that formulate proposed positions and Commission (NRC) seeks qualified appropriate arrangements can be made. actions, as appropriate, for deliberation candidates for the Advisory Committee Electronic recordings will be permitted by the Full Committee. on Reactor Safeguards (ACRS). Submit only during those portions of the Members of the public desiring to resumes to Ms. Kendra Freeland, meeting that are open to the public. provide oral statements and/or written Analyst, ACRS, Mail Stop T2E–26, U.S. Detailed procedures for the conduct of comments should notify the Designated Nuclear Regulatory Commission, and participation in ACRS meetings Federal Official (DFO), Mr. Peter Wen, Washington, DC 20555–0001, or e-mail were published in the Federal Register (Telephone 301–415–2832, E-mail: [email protected]. on October 14, 2009, (74 FR 52829– [email protected]) five days prior to SUPPLEMENTARY INFORMATION: The ACRS 52830). the meeting, if possible, so that is a part-time advisory group, which is Detailed meeting agendas and meeting appropriate arrangements can be made. statutorily mandated by the Atomic transcripts are available on the NRC Thirty-five hard copies of each Energy Act of 1954, as amended. ACRS Web site at http://www.nrc.gov/reading- presentation or handout should be provides independent expert advice on rm/doc-collections/acrs. Information provided to the DFO thirty minutes matters related to the safety of existing regarding topics to be discussed, before the meeting. In addition, one and proposed nuclear power plants and changes to the agenda, whether the electronic copy of each presentation on the adequacy of proposed reactor meeting has been canceled or should be emailed to the DFO one day safety standards. Of primary importance rescheduled, and the time allotted to before meeting. If an electronic copy are the safety issues associated with the present oral statements can be obtained cannot be provided within this operation of 104 commercial nuclear by contacting the DFO. Moreover, in timeframe, presenters should provide power plants in the United States and view of the possibility that the schedule the DFO with a compact disk containing regulatory initiatives, including risk- for ACRS meetings may be adjusted by each presentation at least 30 minutes informed and performance-based the Chairman as necessary to facilitate before the meeting. Electronic regulations, license renewal, power the conduct of the meeting, persons recordings will be permitted only uprates, and the use of mixed oxide and planning to attend should check with during those portions of the meeting high burnup fuels. An increased the DFO if such rescheduling would that are open to the public. Detailed emphasis is being given to safety issues result in major inconvenience. procedures for the conduct of and associated with new reactor designs and technologies, including passive system Dated: January 7, 2010. participation in ACRS meetings were published in the Federal Register on reliability and thermal hydraulic Antonio Dias, October 14, 2009 (74 FR 58268–58269). phenomena, use of digital Chief, Reactor Safety Branch B, Advisory Detailed ACRS meeting agendas and instrumentation and control, Committee on Reactor Safeguards. meeting transcripts are available on the international codes and standards used [FR Doc. 2010–500 Filed 1–12–10; 8:45 am] NRC Web site at http://www.nrc.gov/ in multinational design certifications, BILLING CODE 7590–01–P reading-rm/doc-collections/acrs/. material and structural engineering, Information regarding topics to be nuclear analysis and reactor core discussed, changes to the agenda, performance, and nuclear materials and NUCLEAR REGULATORY whether the meeting has been canceled radiation protection. The ACRS also has COMMISSION or rescheduled, and the time allotted to some involvement in security matters related to the integration of safety and Advisory Committee on Reactor present oral statements can be obtained security of commercial reactors. Safeguards (ACRS); Meeting of the from the Web site cited above or by contacting the identified DFO. See NRC Web site at http:// ACRS Subcommittee on AP1000; www.nrc.gov/aboutnrc/regulatory/ Notice of Meeting Moreover, in view of the possibility that the schedule for ACRS meetings may be advisory/acrs.html for additional The ACRS Subcommittee on the adjusted by the Chairman as necessary information about ACRS. Criteria used AP1000 will hold a meeting on February to facilitate the conduct of the meeting, to evaluate candidates include 2–3, 2010, 11545 Rockville Pike, Room persons planning to attend should check education and experience, demonstrated T2–B1, Rockville, Maryland. with these references if such skills in nuclear reactor safety matters, The meeting will be open to public rescheduling would result in major the ability to solve complex technical attendance. inconvenience. problems, and the ability to work The proposed agenda for the subject collegially on a board, panel, or meeting is as follows: Dated: January 7, 2010. committee. The Commission, in Tuesday, February 2, 2010—8:30 a.m.– Antonio F. Dias, selecting its Committee members, 5 p.m. Chief, Reactor Safety Branch B Advisory considers the need for a specific Wednesday, February 3, 2010—8:30 Committee on Reactor Safeguards. expertise to accomplish the work a.m.–5 p.m. [FR Doc. 2010–498 Filed 1–12–10; 8:45 am] expected to be before the ACRS. ACRS The Subcommittee will review BILLING CODE 7590–01–P Committee members are appointed for selected chapters of the Draft Safety four-year terms and normally serve no Evaluation Report associated with the more than three terms. The Commission amendment to the Westinghouse NUCLEAR REGULATORY looks to fill potential multiple vacancies AP1000 Design Certification Document COMMISSION as a result of this request. For these and the combined license (COL) Seeks Qualified Candidates for the positions, a candidate must have at least application. The Subcommittee will Advisory Committee on Reactor 10 years of broad experience in nuclear hear presentations by and hold Safeguards engineering coupled with operational discussions with Westinghouse, exposure to issues relative to new Southern Nuclear Operating Company AGENCY: U.S. Nuclear Regulatory reactor designs pertaining to digital (SNC), and NRC staff representatives Commission. instrumentation and control, civil/

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structural engineering, or radiation SECURITIES AND EXCHANGE Maritime Administration, Room W21– protection. Candidates with pertinent COMMISSION 318, 1200 New Jersey Ave., SE., graduate level experience will be given Washington, DC 20590; phone: (202) additional consideration. Consistent Sunshine Act Meeting 366–5737; or fax: (202) 366–6988. Key Dates: The period for submitting with the requirements of the Federal Notice is hereby given, pursuant to Advisory Committee Act, the grant applications, as mandated by the provisions of the Government in the statute, commenced on December 16, Commission seeks candidates with Sunshine Act, Public Law 94–409, that diverse backgrounds, so that the 2009 and will terminate on February 16, the Securities and Exchange 2010. The applications must be received membership on the Committee is fairly Commission will hold a Closed Meeting by the Maritime Administration by 5 balanced in terms of the points of view on Monday, January 11, 2010 at 10:30 p.m. EST on February 16, 2010. represented and functions to be a.m. Applications received later than this performed by the Committee. Commissioners, Counsel to the time will not be considered. The Candidates will undergo a thorough Commissioners, the Secretary to the Maritime Administration intends to security background check to obtain the Commission, and recording secretaries award grants no later than April 15, security clearance that is mandatory for will attend the Closed Meeting. Certain 2010. all ACRS members. The security staff members who have an interest in Funding Opportunity: Section 54101 background check will involve the the matters also may be present. of Title 46, United States Code, and the completion and submission of The General Counsel of the section entitled ‘‘Assistance to Small paperwork to NRC. Commission, or his designee, has Shipyards’’ in the Consolidated certified that, in his opinion, one or Appropriations Act, 2010 (Pub. L. 111– Candidates for ACRS appointments more of the exemptions set forth in 5 may be involved in or have financial 117), provide that the Maritime U.S.C. 552b(c)(10) and 17 CFR Administration shall establish an interests related to NRC-regulated 200.402(a)(10), permit consideration of assistance program for small shipyards. aspects of the nuclear industry. the scheduled matter at the Closed Under this program, there is currently However, because conflict-of-interest Meeting. $14,700,000 available for grants for considerations may restrict the Commissioner Walter, as duty officer, capital and related improvements for participation of a candidate in ACRS voted to consider the item listed for the qualified shipyard facilities that will be activities, the degree and nature of any Closed Meeting in a closed session, and effective in fostering efficiency, such restriction on an individual’s determined that no earlier notice thereof competitive operations, and quality ship activities as a member will be was possible. construction, repair, and considered in the selection process. The subject matter of the Closed reconfiguration. ($300,000 of the Each qualified candidate’s financial Meeting scheduled for Monday, January $15,000,000 appropriated for the interests must be reconciled with 11, 2010 will be: post argument program is reserved for program applicable Federal and NRC rules and discussion. administration.) Such grants may not be regulations prior to final appointment. At times, changes in Commission used to construct buildings or other This might require divestiture of priorities require alterations in the physical facilities or to acquire land securities or discontinuance of certain scheduling of meeting items. unless such use is specifically approved For further information and to contracts or grants. Information by the Maritime Administration as being ascertain what, if any, matters have been regarding these restrictions will be consistent with and supplemental to added, deleted or postponed, please provided upon request. A re´sume´ capital and related infrastructure contact: improvements. Grant funds may also be describing the educational and The Office of the Secretary at (202) professional background of the used for maritime training programs to 551–5400. foster technical skills and operational candidate, including any special Dated: January 11, 2010. productivity in communities whose accomplishments, publications, and economies are related to or dependent professional references should be Florence E. Harmon, Deputy Secretary. upon the maritime industry. Grants for provided. Candidates should provide such training programs may only be [FR Doc. 2010–592 Filed 1–11–10; 4:15 pm] their current address, telephone awarded to ‘‘Eligible Applicants’’ as number, and e-mail address. All BILLING CODE 8011–01–P described below but training programs candidates will receive careful can be established through vendors to consideration. Appointment will be such applicants. made without regard to factors such as DEPARTMENT OF TRANSPORTATION Award Information: The Maritime race, color, religion, national origin, sex, Administration intends to award the full Maritime Administration age, or disabilities. Candidates must be amount of the available funding through citizens of the United States and be able Assistance to Small Shipyards Grant grants to the extent that there are worthy to devote approximately 100 days per Program applications. No more than 25 percent year to Committee business. Resumes of the funds available will be awarded will be accepted until April 13, 2010. AGENCY: Maritime Administration, to shipyard facilities in one geographic Department of Transportation, Office of location that have more than 600 Dated: January 7, 2010. Shipyards and Marine Technology. production employees. The Maritime Annette Vietti-Cook, ACTION: Notice of Small Shipyard Grant Administration will seek to obtain the Secretary of the Commission. Program. maximum benefit from the available [FR Doc. 2010–494 Filed 1–12–10; 8:45 am] funding by awarding grants for as many Catalog of Federal Domestic Assistance BILLING CODE 7590–01–P of the most worthy projects as possible. Number: 20.814. The Maritime Administration may FOR FURTHER INFORMATION CONTACT: Carl partially fund applications by selecting Setterstrom, Director, Office of parts of the total project. The start date Shipyards and Marine Engineering, and period of performance for each

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award will depend on the specific shipyard; (b) a description of the Section 6: Shipyard company officer’s project and must be agreed to by the shipyard facilities; (c) years in certification of each of the following Maritime Administration. operation; (d) ownership; (e) customer requirements: Eligibility Information: 1. Eligible base; (f) current order book including (a) That the shipyard facility for Applicants—the statutes referenced in type of work; (g) vessels delivered (or which a grant is sought is located in a ‘‘Funding Opportunity’’ above provide major projects) over last 5 years; and (h) single geographical location in or near a that shipyards can apply for grants. The Web site address, if any. maritime community and (i) the shipyard facility for which a grant is Section 2: For each project proposed shipyard facility has no more than 600 sought must be in a single geographical for funding the following: production employees, or (ii) the location, located in or near a maritime (a) A comprehensive detailed shipyard facility has more than 600 community, and may not have more description of the project including a production employees, but less than than 1,200 production employees. The statement of whether the project will 1,200 production employees (the applicant must be the operating replace existing equipment, and if so the shipyard officer must certify to one or company of the shipyard facility. The disposition of the replaced equipment. the other of (i) or (ii)); shipyard facility must construct, repair, (b) That the applicant has the (b) A description of the need for the or reconfigure vessels 40 ft. in length or authority to carry out the proposed project in relation to shipyard greater, for commercial or government project; and use. 2. Eligible Projects—capital and operations and business plan and an (c) Certification in accordance with related improvement projects that will explanation of how the project will the Department of Transportation’s be effective in fostering efficiency, fulfill this need. regulation restricting lobbying, 49 CFR competitive operations, and quality ship (c) A quantitative analysis part 20, that the applicant has not, and construction, repair, and demonstrating how the project will be will not, make any prohibited payments reconfiguration; and training projects effective in fostering efficiency, out of the requested grant. that will be effective in fostering competitive operations, and quality ship Certifications are not required to be employee skills and enhancing construction, repair, or reconfiguration notarized. productivity. For capital improvement (for capital improvement projects) or Section 7: Unique identifier of projects all items proposed for funding how the project will be effective in shipyard’s parent company (when must be new and to be owned by the fostering employee skills and enhancing applicable): Data Universal Numbering applicant. For both capital improvement productivity (for training projects). The System (DUNS + 4 number) (when and training projects all project costs, analysis should quantify the benefits of applicable). including the recipients share, must be the projects in terms of man-hours Section 8: 2008 or 2009 (if available) incurred after the date of the grant saved, dollars saved, percentages, or year-end audited, reviewed or compiled agreement. other meaningful metrics. The financial statements, prepared by a Matching Requirements: The Federal methodology of the analysis should be certified public accountant, according to funds for any eligible project will not explained with assumptions used U.S. generally accepted accounting exceed 75 percent of the total cost of identified and justified. principles, not on an income tax basis. such project. However, for good cause (d) A detailed methodology and September 30, 2009 financial statements shown, the Maritime Administrator may timeline for implementing the project. prepared by the company if December waive the matching requirement in (e) A detailed itemization of the cost 31, 2009 CPA-prepared statements are whole or in part. The remaining portion of the project together with supporting not available. Do not provide tax of the cost shall be paid in funds from documentation, including current returns. or on behalf of the recipient. The vendor quotes and estimates of Section 9: Statement regarding the applicant is required to submit detailed installation costs. relationship between applicants and any financial statements and supporting (f) A statement explaining if any parents, subsidiaries or affiliates, if any documentation demonstrating how and elements of the project require action such entity is going to provide a portion when such matching requirement is under the National Environmental of the match. Section 10: Evidence documenting proposed to be funded as described Policy Act (42 U.S.C. sec. 4321, et seq.) applicant’s ability to make proposed below. The recipient’s entire matching or require any licenses or permits. Items requirement must be paid prior to matching requirement (loan agreement, 2(a) thru 2(f) should be repeated, in payment of any federal funds for the commitment from investors, cash on order, for each separate project included project. balance sheet, etc.) and in the times in the application. Application: An application should outlined in 2(d) above. be filed on standard Form SF–424 Section 3: A table with a prioritized Section 11: Pro-forma financial which can be found on the Internet at list of projects and total cost and statements reflecting (a) September 30, http://www.Marad.dot.gov. Although Government portion (in dollars) for or December 31, 2009 financial the form is available electronically, the each. condition; (b) effect on balance sheet of application must be filed in hard copy Section 4: A description of any grant and matching funds (i.e., a as indicated below due to the amount of existing programs or arrangements, if decrease in cash or increase in debt, information requested. A shipyard any, which will be used to supplement additional equity and an increase in facility in a single geographic location or leverage the federal grant assistance. fixed assets); and (c) impact on applying for multiple projects must do Section 5: Special economic company’s projected financial condition so in a single application. The circumstances and conditions, if any, of (balance sheet) of completion of project, application for a grant must include all the maritime community in which the showing that company will have of the following information as an shipyard is located (beyond that which sufficient financial resources to remain addendum to Form SF–424. The is reflected in the unemployment rate of in business. information should be organized in the county in which the shipyard is Section 12: Statement whether during sections as described below: located and whether that county is in an the past five years, the applicant or any Section 1: A description of the economically distressed area, as defined predecessor or related company has shipyard including (a) location of the by 42 U.S.C. 3161). been in bankruptcy or in reorganization

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under Chapter 11 of the Bankruptcy rather than expand the capabilities of Programs Staff, Federal Aviation Code, or in any insolvency or the shipyard into new product lines or Administration, Western-Pacific Region reorganization proceedings, and capabilities; and (4) that result in a Headquarters, P.O. Box 92007, Los whether any substantial property of the geographic diversity of grant recipients. Angeles, CA 90009–2007, telephone: applicant or any predecessor or related Potential applicants are advised that it (310) 725–3800, e-mail: company has been acquired in any such is expected, based on past experience, [email protected], or Karen Trevino, proceeding or has been subject to that applications will far exceed the National Park Service, Natural Sounds foreclosure or receivership during such funds available and that only a small Program, 1201 Oakridge Dr., Suite 100, period. If so, give details. percentage of applications will be Fort Collins, CO 80525, telephone (970) Additional information may be funded. It is anticipated that between 10 225–3563, e-mail: requested as deemed necessary by the and 15 applications will be selected for [email protected]. Maritime Administration in order to funding with an average grant amount of SUPPLEMENTARY INFORMATION: facilitate and complete its review of the $1 to $1.5 million. application. If such information is not Conditions Attached to Awards: The Background provided, the Maritime Administration grant agreement will set out the records The National Parks Air Tour may deem the application incomplete to be maintained by the recipient that Management Act of 2000 (the Act) was and cease processing it. must be available for review and audit enacted on April 5, 2000, as Public Law Where to File Application: Submit an by the Maritime Administration, as well original copy and one additional paper 106–181. The Act required the as any other conditions and establishment of the advisory group copy of the application and two CDs requirements. each containing an electronic copy only, within 1 year after its enactment. The no additional information of the Dated: January 7, 2010. advisory group was established in application in PDF format to: Associate By Order of the Acting Maritime March 2001, and is comprised of a Administrator for Business and Administrator. balanced group of representatives of Workforce Development, Room W21– Murray Bloom, general aviation, commercial air tour 318, Maritime Administration, 1200 Acting Secretary, Maritime Administration. operations, environmental concerns, New Jersey Ave., SE., Washington, DC [FR Doc. 2010–475 Filed 1–12–10; 8:45 am] and Native American tribes. The Administrator of the FAA and the 20590. BILLING CODE 4910–81–P Evaluation of Applications: The Director of NPS (or their designees) Maritime Administration will evaluate serve as ex officio members of the the applications on the basis of how DEPARTMENT OF TRANSPORTATION group. Representatives of the well the project for which a grant is Administrator and Director serve requested would be effective in fostering Federal Aviation Administration alternating 1-year terms as chairman of efficiency, competitive operations, and the advisory group. quality ship construction, repair, and Membership Availability in the National The advisory group provides ‘‘advice, reconfiguration (for capital Parks Overflights Advisory Group information, and recommendations to improvement projects) or how well the Aviation; Rulemaking Committee To the Administrator and the Director— project for which a grant is requested Represent Commercial Air Tour (1) On the implementation of this title would be effective in fostering employee Concerns [the Act] and the amendments made by skills and enhancing productivity (for this title; ACTION: Notice. training projects) and the economic (2) On commonly accepted quiet circumstances and conditions of the SUMMARY: The National Park Service aircraft technology for use in surrounding community. The economic (NPS) and the Federal Aviation commercial air tour operations over a circumstances and conditions will be Administration (FAA), as required by national park or tribal lands, which will based upon the unemployment rate of the National Parks Air Tour receive preferential treatment in a given the county in which the shipyard is Management Act of 2000, established air tour management plan; located and whether that county is an the National Parks Overflights Advisory (3) On other measures that might be economically distressed area, Group (NPOAG) in March 2001. The taken to accommodate the interests of supplemented by any special economic NPOAG was formed to provide visitors to national parks; and circumstances and conditions identified continuing advice and counsel with (4) On safety, environmental, and by the applicant. The Maritime respect to commercial air tour other issues related to commercial air Administration will award grants in its operations over and near national parks. tour operations over a national park or sole discretion in such amounts and This notice informs the public of one tribal lands.’’ under such conditions it determines vacancy (due to completion of Members of the advisory group may will best further the statutory purposes membership on May 19, 2010) on the be allowed certain travel expenses as of the small shipyard grant program. NPOAG (now the NPOAG Aviation authorized by section 5703 of Title 5, Projects that may require additional Rulemaking Committee (ARC)) for a United States Code, for intermittent environmental assessments such as member representing commercial air Government service. those including waterside tour operator concerns and invites By FAA Order No. 1110–138, signed improvements (dredging, bulk heading, interested persons to apply to fill the by the FAA Administrator on October pier work, pilings, etc.) will not be vacancy. 10, 2003, the NPOAG became an considered for funding. Preference will Aviation Rulemaking Committee (ARC). be given to funding applications: (1) DATES: Persons interested in serving on FAA Order No. 1110–138, was amended From companies that have not the NPOAG ARC should contact Mr. and became effective as FAA Order No. previously been awarded a small Barry Brayer at the mailing or e-mail 1110–138A, on January 20, 2006. shipyard grant; (2) that propose address below in writing on or before The current NPOAG ARC is made up matching funds greater than a 25% February 19, 2010. of one member representing general share of the project; (3) that impact FOR FURTHER INFORMATION CONTACT: aviation, three members representing existing operations and/or product lines Barry Brayer, AWP–1SP, Special the commercial air tour industry, four

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members representing environmental SUMMARY: FMCSA announces receipt of (65 FR 19476). This information is also concerns, and two members applications from 33 individuals for available at http://www.regulations.gov. representing Native American tribal exemption from the vision requirement FOR FURTHER INFORMATION CONTACT: Dr. concerns. Current members of the in the Federal Motor Carrier Safety Mary D. Gunnels, Director, Medical NPOAG ARC are: Robert Hackman, Regulations. If granted, the exemptions Programs, (202) 366–4001, Aircraft Owners and Pilots Association; would enable these individuals to [email protected], FMCSA, Alan Stephen, fixed-winged air tour qualify as drivers of commercial motor Department of Transportation, 1200 operator representative; Elling vehicles (CMVs) in interstate commerce New Jersey Avenue, SE., Room W64– Halvorson, Papillon Airways, Inc.; without meeting the Federal vision 224, Washington, DC 20590–0001. Matthew Zuccaro, Helicopter standard. Office hours are from 8:30 a.m. to 5 Association International; Chip DATES: Comments must be received on p.m., Monday through Friday, except Dennerlein, Siskiyou Project; Gregory or before February 12, 2010. Federal holidays. Miller, American Hiking Society; ADDRESSES: You may submit comments SUPPLEMENTARY INFORMATION: Kristen Brengel, National Parks bearing the Federal Docket Management Conservation Association; Bryan Background System (FDMS) Docket ID FMCSA– Faehner, National Parks Conservation 2009–0321 using any of the following Under 49 U.S.C. 31136(e) and 31315, Association; Rory Majenty, Hualapai methods: FMCSA may grant an exemption for a 2- Nation; and Ray Russell, Navajo Parks • Federal eRulemaking Portal: Go to year period if it finds ‘‘such exemption and Recreation. http://www.regulations.gov. Follow the would likely achieve a level of safety Public Participation in the NPOAG on-line instructions for submitting that is equivalent to, or greater than, the ARC comments. level that would be achieved absent • Mail: Docket Management Facility; such exemption.’’ FMCSA can renew In order to retain balance within the U.S. Department of Transportation, 1200 exemptions at the end of each 2-year NPOAG ARC, the FAA and NPS invite New Jersey Avenue, SE., West Building period. The 33 individuals listed in this persons interested in serving on the Ground Floor, Room W12–140, notice have each requested an ARC to represent commercial air tour Washington, DC 20590–0001. exemption from the vision requirement operator concerns, to contact Mr. Barry • Hand Delivery: West Building in 49 CFR 391.41(b)(10), which applies Brayer (contact information is written Ground Floor, Room W12–140, 1200 to drivers of CMVs in interstate above in FOR FURTHER INFORMATION New Jersey Avenue, SE., Washington, commerce. Accordingly, the Agency CONTACT). DC, between 9 a.m. and 5 p.m., Monday will evaluate the qualifications of each Requests to serve on the ARC must be through Friday, except Federal applicant to determine whether granting made to Mr. Brayer in writing and Holidays. an exemption will achieve the required postmarked or e mailed on or before • Fax: 1–202–493–2251. level of safety mandated by statute. February 19, 2010. The request should Each submission must include the Qualifications of Applicants indicate whether or not you are a Agency name and the docket ID for this member of an association or group Notice. Note that DOT posts all Bradley T. Alspach representing commercial air tours, or comments received without change to Mr. Alspach, age 50, has had have another affiliation with issues http://www.regulations.gov, including amblyopia in his left eye since relating to aircraft flights over national any personal information included in a childhood. The best corrected visual parks. The request should also state comment. Please see the Privacy Act acuity in his right eye is 20/20 and in what expertise you would bring to the heading below. his left eye, 20/200. Following an NPOAG ARC as related to the vacancy Docket: For access to the docket to examination in 2009, his you are seeking to fill (e.g., commercial read background documents or ophthalmologist noted, ‘‘In my opinion, air tour concerns). The term of service comments, go to http:// he has sufficient vision to perform the for NPOAG ARC members is 3 years. www.regulations.gov at any time or driving tasks required to operate a Issued in Hawthorne, CA on January 6, Room W12–140 on the ground level of commercial vehicle.’’ Mr. Alspach 2010. the West Building, 1200 New Jersey reported that he has driven straight Barry Brayer, Avenue, SE., Washington, DC, between trucks for 16 years, accumulating NPOAG Chairman, Manager, Special 9 a.m. and 5 p.m., Monday through 332,800 miles, and buses for 7 months, Programs Staff, Western-Pacific Region. Friday, except Federal holidays. The accumulating 2,625 miles. He holds a [FR Doc. 2010–386 Filed 1–12–10; 8:45 am] FDMS is available 24 hours each day, Class B Commercial Driver’s License BILLING CODE 4910–13–M 365 days each year. If you want (CDL) from Illinois. His driving record acknowledgment that we received your for the last 3 years shows no crashes and comments, please include a self- no convictions for moving violations in DEPARTMENT OF TRANSPORTATION addressed, stamped envelope or a CMV. postcard or print the acknowledgement Federal Motor Carrier Safety page that appears after submitting William M. Arbogast Administration comments on-line. Mr. Arbogast, 58, has a macular scar Privacy Act: Anyone may search the in his left eye due to a traumatic injury [Docket ID. FMCSA–2009–0321] electronic form of all comments sustained in 1968. The best corrected received into any of our dockets by the visual acuity in his right eye is 20/20 Qualification of Drivers; Exemption name of the individual submitting the and in his left eye, 20/1600. Following Applications; Vision comment (or of the person signing the an examination in 2009, his optometrist AGENCY: Federal Motor Carrier Safety comment, if submitted on behalf of an noted, ‘‘It is my opinion that Mr. Administration (FMCSA), DOT. association, business, labor union, etc.). Arbogast has sufficient vision to safely You may review the DOT’s complete drive and operate a commercial ACTION: Notice of applications for Privacy Act Statement in the Federal vehicle.’’ Mr. Arbogast reported that he exemptions; request for comments. Register published on April 11, 2000 has driven straight trucks for 40 years,

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accumulating 900,000 miles, and acuity in his right eye is 20/20 and in straight trucks for 8 months, tractor-trailer combinations for 30 years, his left eye, 20/400. Following an accumulating 40,000 miles, and tractor- accumulating 675,000 miles. He holds a examination in 2009, his trailer combinations for 20 years, Class A CDL from Florida. His driving ophthalmologist noted, ‘‘It is my opinion accumulating 1 million miles. He holds record for the last 3 years shows no that Mr. Contreras does have sufficient a Class A CDL from North Carolina. His crashes and no convictions for moving vision to perform the driving tasks driving record for the last 3 years shows violations in a CMV. required to operate a commercial no crashes and two convictions for vehicle.’’ Mr. Contreras reported that he speeding in a CMV. In both instances, John E. Cain has driven buses for 8 years, he exceeded the speed limit by 9 miles Mr. Cain, 59, has a retinal detachment accumulating 16,000 miles. He holds a per hour (mph). in his left eye due to a traumatic injury Class B CDL from New Mexico. His Daniel W. Doshier sustained as a child. The best corrected driving record for the last 3 years shows visual acuity in his right eye is 20/20 no crashes and no convictions for Mr. Doshier, 61, has aphakia in his and in his left eye, light perception moving violations in a CMV. right eye due to a traumatic injury only. Following an examination in 2009, sustained at age 17. The best corrected Curtis J. Crowston his optometrist noted, ‘‘In my medical visual acuity in his right eye is 20/20 opinion, Mr. Cain has sufficient vision Mr. Crowston, 44, has a prosthetic left and in his left eye, 20/400. Following an to perform the driving tasks required to eye due to a traumatic injury sustained examination in 2009, his optometrist operate a commercial vehicle.’’ Mr. Cain in 1996. The visual acuity in his left eye noted, ‘‘I feel Mr. Doshier is visually reported that he has driven straight is 20/50. Following an examination in able to perform any commercial driving trucks for 28 years, accumulating 2009, his optometrist noted, ‘‘In my tasks that he may be asked to do.’’ Mr. 350,000 miles. He holds a Class B CDL opinion, based on his monocular Doshier reported that he has driven from New Mexico. His driving record standing of visual acuity, color vision, straight trucks for 4 years, accumulating for the last 3 years shows no crashes and and visual field testing, that Curtis has 36,000 miles. He holds a Class B CDL no convictions for moving violations in sufficient vision to perform the driving from Arkansas. His driving record for a CMV. tasks required to operate a commercial the last 3 years shows no crashes and vehicle.’’ Mr. Crowston reported that he one conviction for speeding in a CMV. Terry A. Crites has driven straight trucks for 6 years, He exceeded the speed limit by 15 mph. Mr. Crites, 41, has had refractive accumulating 180 miles, and tractor- Charles L. Dunn amblyopia in his left eye since trailer combinations for 5 years, childhood. The visual acuity in his right accumulating 100,000 miles. He holds a Mr. Dunn, 43, has had retinal eye is 20/20 and in his left eye, 20/200. Class A CDL from North Dakota. His detachment in his right eye since 1999. Following an examination in 2009, his driving record for the last 3 years shows The best corrected visual acuity in his optometrist noted, ‘‘Mr. Terry Crites in no crashes and no convictions for right eye is hand-motion vision and in my medical opinion has sufficient moving violations in a CMV. his left eye, 20/15. Following an vision to perform the driving tasks examination in 2009, his optometrist Jim L. Davis required to operate a commercial noted, ‘‘In my opinion, Mr. Dunn has vehicle.’’ Mr. Crites reported that he has Mr. Davis, 54, has complete loss of sufficient vision to perform the driving driven tractor-trailer trucks for 18 years, vision in his right eye due to a traumatic tasks required to operate a commercial accumulating 1.4 million miles. He injury sustained during childhood. The vehicle at this time.’’ Mr. Dunn reported holds a Class A CDL from West Virginia. best corrected visual acuity in his left that he has driven straight trucks for 8c His driving record for the last 3 years eye is 20/20. Following an examination years, accumulating 743,750 miles, and shows no crashes and two convictions in 2009, his optometrist noted, ‘‘It was tractor-trailer combinations for 20 years, for moving violations in a CMV. In one my opinion that Mr. Davis had accumulating 1.7 million miles. He instance, he exceeded the speed limit by sufficient vision to perform the tasks holds a Class A CDL from Oklahoma. 4 mph and in the other, by 16 mph. required to drive a commercial vehicle.’’ His driving record for the last 3 years Mr. Davis reported that he has driven shows no crashes and two convictions Daniel M. Cannon straight trucks for 5 years, accumulating for speeding in a CMV. In one instance, Mr. Cannon, 35, has had glaucoma in 650,000 miles, and tractor-trailer he exceeded the speed limit by 10 mph his right eye since birth. The visual combinations for 2 years, accumulating and in the other by 12 mph. acuity in his right eye is light perception 100,000 miles. He holds a Class B CDL Andrew G. Fornsel only and in his left eye, 20/15. from New Mexico. His driving record Following an examination in 2009, his for the last 3 years shows no crashes and Mr. Fornsel, 46, has complete loss of optometrist noted, ‘‘It is my opinion that no convictions for moving violations in vision in his right eye due to phtitesis Daniel has sufficient vision to perform a CMV. bulbi caused by a traumatic injury the driving tasks required to operate a sustained 39 years ago. The visual Clifford W. Doran, Jr. commercial vehicle.’’ Mr. Cannon acuity in his left eye is 20/20. Following reported that he has driven straight Mr. Doran, 49, has a macular scar in an examination in 2009, his optometrist trucks for 11 years, accumulating 16,500 his left eye due to ocular histoplasmosis noted, ‘‘It is my professional opinion miles. He holds a Class B CDL from syndrome. The best corrected visual that Mr. Andrew Fornsel has sufficient Oregon. His driving record for the last acuity in his right eye is 20/15 and in vision to perform any and all the driving 3 years shows no crashes and no his left eye, 20/300. Following an tasks required to operate a commercial convictions for moving violations in a examination in 2009, his vehicle.’’ Mr. Fornsel reported that he CMV. ophthalmologist noted, ‘‘His vision is has driven straight trucks for 25 years, best corrected and he is doing fine and accumulating 750,000 miles, and Eugene Contreras I think he is okay to be able to drive a tractor-trailer combinations for 20 years, Mr. Contreras, 68, has corneal scarring commercial vehicle because of his good accumulating 1 million miles. He holds in his left eye due to trauma sustained peripheral vision in both eyes.’’ Mr. a Class A CDL from New York. His as a child. The best corrected visual Doran reported that he has driven driving record for the last 3 years shows

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no crashes and no convictions for Guy A. Lanham reported that he has driven straight moving violations in a CMV. Mr. Lanham, 47, has had complete trucks for 4 years, accumulating 120,000 miles. He holds a Class D operator’s Jamie L. French loss of vision in his right eye due to a corneal ulcer diagnosed in 2003 and two license from Alabama. His driving Mr. French, 45, has a macular scar in failed corneal transplants. The visual record for the last 3 years shows no his right eye due to toxoplasmosis acuity in his left eye is 20/20. Following crashes and no convictions for moving which occurred in 1999. The visual an examination in 2009, his optometrist violations in a CMV. acuity in his right eye is 20/200, and in noted, ‘‘It is my professional opinion Millard F. Neace, II his left eye, 20/20 . Following an that Mr. Lanham has sufficient vision to examination in 2009, his perform driving tasks required to Mr. Neace, 36, has a retinal ophthalmologist noted, ‘‘In my opinion, operate a commercial vehicle.’’ Mr. detachment in his left eye which Mr. French has vision that is sufficient Lanham reported that he has driven occurred in 1996. The best corrected to perform the driving tasks required to straight trucks for 3 years, accumulating visual acuity in his right eye is 20/20 operate a commercial vehicle.’’ Mr. 72,000 miles, and tractor-trailer and in his left eye, 20/60. Following an French reported that he has driven combinations for 12 years, accumulating examination in 2009, his optometrist 1.5 million miles. He holds a Class A straight trucks for 2c years, noted, ‘‘Due to the stable chronic CDL from Florida. His driving record for accumulating 77,500 miles, and tractor- condition of his left eye, he has the last 3 years shows no crashes and trailer combinations for 13 years, sufficient vision to operate a one conviction for speeding in a CMV. commercial vehicle.’’ Mr. Neace accumulating 540,800 miles. He holds a He exceeded the speed limit by 20 mph. Class A CDL from North Carolina. His reported that he has driven straight driving record for the last 3 years shows Glenn Lewis trucks for 3 years, accumulating 216,000 miles, and tractor-trailer combinations no crashes and no convictions for Mr. Lewis, 41, has had amblyopia in moving violations in a CMV. his right eye since birth. The best for 4 years, accumulating 280,000 miles. corrected visual acuity in his right eye He holds a Class A CDL from West Archie C. Hillsman is 20/70 and in his left eye, 20/20. Virginia. His driving record for the last 3 years shows no crashes and no Mr. Hillsman, 56, has complete loss of Following an examination in 2009, his optometrist noted, ‘‘In my opinion, from convictions for moving violations in a vision in his left eye due to a traumatic CMV. injury sustained during childhood. The past performance and the current vision best corrected visual acuity in his right situation, Glenn should still be able to Frank L. Ortolani eye is 20/20. Following an examination operate a commercial vehicle effectively in 2009, his optometrist noted, ‘‘Archie’s for his employment, just as he has done Mr. Ortolani, 56, has had amblyopia ’’ vision is sufficient to perform the for the past 12 years. Mr. Lewis in his right eye since birth. The best reported that he has driven straight driving tasks required to operate a corrected visual acuity in his right eye trucks for 15 years, accumulating 3 is 20/200 and in his left eye, 20/20. commercial vehicle.’’ Mr. Hillsman million miles. He holds a Class A CDL Following an examination in 2009, his reported that he has driven straight from Ohio. His driving record for the optometrist noted, ‘‘Although he may trucks for 4 years, accumulating 40,000 last 3 years shows no crashes and no not have good central snellen visual miles, and tractor-trailer combinations convictions for moving violations in a acuity in the right eye, he does maintain for 51⁄2 years, accumulating 343,750 CMV normal peripheral visual fields which is miles. He holds a Class A CDL from sufficient to perform the driving test Oregon. His driving record for the last James M. McCormick required to operate a commercial 3 years shows no crashes and no Mr. McCormick, 42, has had vehicle.’’ Mr. Ortolani reported that he convictions for moving violations in a amblyopia in his right eye since birth. has driven straight trucks for 15 years, CMV. The best corrected visual acuity in his accumulating 375,000 miles. He holds a right eye is 20/60 and in his left eye, 20/ Amos W. Hulsey Class B CDL from Ohio. His driving 15. Following an examination in 2009, record for the last 3 years shows no Mr. Hulsey, 42, has complete loss of his ophthalmologist noted, ‘‘I do believe crashes and no convictions for moving vision in his right eye since birth. The he is capable of safely operating a violations in a CMV. visual acuity in his left eye is 20/20. commercial motor vehicle in interstate Following an examination in 2009, his commerce with his current vision.’’ Mr. Paul D. Prillaman McCormick reported that he has driven optometrist noted, ‘‘It is my opinion that Mr. Prillaman, 47, has a prosthetic left if Mr. Hulsey meets the standard straight trucks for 15 years, accumulating 75,000 miles. He holds a eye due to corneal dystrophy which requirements for the U.S. Department of Class A CDL from Idaho. His driving began as a child. The visual acuity in Transportation Safety Administration, record for the last 3 years shows no his right eye is 20/20. Following an he does have sufficient vision in the left crashes and no convictions for moving examination in 2009, his eye to perform the driving tasks violations in a CMV. ophthalmologist noted, ‘‘It is my required to operate a commercial professional medical opinion that Mr. vehicle.’’ Mr. Hulsey reported that he Shane W. Mincey Prillaman does have sufficient vision to has driven straight trucks for 5 years, Mr. Mincey, 38, has corneal scarring perform the driving tasks required to accumulating 250,000 miles, and in his right eye due to a traumatic injury operate a commercial vehicle.’’ Mr. tractor-trailer combinations for 6 years, sustained as a child. The best corrected Prillaman reported that he has driven accumulating 420,000 miles. He holds a visual acuity in his right eye is 20/200 straight trucks for 31 years, Class D operator’s license from and in his left eye, 20/20. Following an accumulating 1.7 million miles. He Alabama. His driving record for the last examination in 2009, his optometrist holds a Class B CDL from Virginia. His 3 years shows no crashes and no noted, ‘‘In my medical opinion, I feel driving record for the last 3 years shows convictions for moving violations in a Shane has sufficient vision to operate a no crashes and no convictions for CMV. commercial vehicle safely.’’ Mr. Mincey moving violations in a CMV.

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Scott A. Randol straight trucks for 8 years, accumulating corrected visual acuity in his right eye Mr. Randol, 50, has had a cataract in 28,800 miles, and tractor-trailer is 20/20 and in his left eye, 20/50. his right eye since birth. The visual combinations for 7 years, accumulating Following an examination in 2009, his acuity in his right eye is 20/70, and in 25,200 miles. He holds a Class B CDL optometrist noted, ‘‘In my medical his left eye, 20/20. Following an from New Mexico. His driving record opinion, Mr. Vickery has sufficient examination in 2009, his optometrist for the last 3 years shows no crashes and vision to perform the driving tasks noted, ‘‘In my medical opinion, Mr. no convictions for moving violations in required to operate a commercial Randol has sufficient vision to perform a CMV. vehicle.’’ Mr. Vickery reported that he has driven tractor-trailer combinations the driving tasks required to operate a Dennis R. Schneider commercial vehicle.’’ Mr. Randol for 4 years, accumulating 208,000 miles. reported that he has driven straight Mr. Schneider, 70, has had amblyopia He holds a Class A CDL from Kentucky. trucks for 30 years, accumulating in his right eye since birth. The best His driving record for the last 3 years 300,000 miles, and tractor-trailer corrected visual acuity in his right eye shows no crashes and no convictions for combinations for 30 years, accumulating is 20/200 and in his left eye, 20/20. moving violations in a CMV. Following an examination in 2009, his 300,000 miles. He holds a Class A CDL Billy R. Wilkey from Missouri. His driving record for optometrist noted, ‘‘In my opinion, Mr. Wilkey, 63, has had amblyopia in the last 3 years shows no crashes and no Dennis has the visual ability to perform his right eye since birth. The best convictions for moving violations in a the driving tasks of a commercial corrected visual acuity in his right eye CMV. vehicle.’’ Mr. Schneider reported that he has driven straight trucks for 53 years, is 20/200 and in his left eye, 20/20. Samuel E. Rees accumulating 31,800 miles, and buses Following an examination in 2009, his Mr. Rees, 43, has a corneal scar in his for 46 years, accumulating 253,000 ophthalmologist noted, ‘‘Mr. Wilkey’s right eye which occurred in 2004. The miles. He holds a Class A CDL from vision is sufficient to continue operating best corrected visual acuity in his right New Mexico. His driving record for the a commercial motor vehicle, in my eye is 20/60 and in his left eye, 20/20. last 3 years shows no crashes and no opinion.’’ Mr. Wilkey reported that he Following an examination in 2009, his convictions for moving violations in a has driven straight trucks for 21 years, optometrist noted, ‘‘Mr. Rees should CMV. accumulating 168,000 miles, and tractor-trailer combinations for 21 years, have no visual problem operating a Michael D. Stevens commercial vehicle.’’ Mr. Rees reported accumulating 168,000 miles. He holds a that he has driven straight trucks for 10 Mr. Stevens, 47, has had amblyopia in Class A CDL from Texas. His driving years, accumulating 400,000 miles. He his right eye since birth. The best record for the last 3 years shows no holds a Class A CDL from Arizona. His corrected visual acuity in his right eye crashes and no convictions for moving driving record for the last 3 years shows is 20/70, and in his left eye, 20/20. violations in a CMV. Following an examination in 2009, his no crashes and no convictions for James H. Williams, Jr. moving violations in a CMV. ophthalmologist noted, ‘‘In my medical opinion, the patient has sufficient vision Mr. Williams, 62, has had retinal Danny L. Rolfe to perform the driving tasks required to detachment in his left eye due to a Mr. Rolfe, 43, has retinal detachment operate a commercial vehicle.’’ Mr. traumatic injury sustained in 1985. The in his right eye due to a traumatic injury Stevens reported that he has driven best corrected visual acuity in his right sustained at age 18. The best corrected tractor-trailer combinations for 9 years, eye is 20/25 and in his left eye, 20/200. visual acuity in his left eye is 20/20. accumulating 144,000 miles. He holds a Following an examination in 2009, his Following an examination in 2009, his Class A CDL from Michigan. His driving optometrist noted, ‘‘I do believe that Mr. optometrist noted, ‘‘From a vision record for the last 3 years shows no Williams has sufficient visual field in perspective, I don’t see any limitation to crashes and no convictions for moving his left eye that will not hinder his Dan’s demonstrated ability to safely violations in a CMV. capability for driving. His right eye has drive and operate commercial vehicles, been trained to compensate for the blur Thomas G. Tomasiewicz it is my opinion that he is seeing straight ahead. I do recommend yearly adequately to continue driving.’’ Mr. Mr. Tomasiewicz, 63, has had testing to follow his condition and Rolfe reported that he has driven amblyopia in his right eye since birth. capabilities.’’ Mr. Williams reported that straight trucks for 25 years, The best corrected visual acuity in his he has driven straight trucks for 5 years, accumulating 125,000 miles, and right eye is 20/200 and in his left eye, accumulating 150,000 miles, and tractor-trailer combinations for 23 years, 20/20. Following an examination in tractor-trailer combinations for 35 years, accumulating 1.2 million miles. He 2009, his optometrist noted, ‘‘I do certify accumulating 2.6 million miles. He holds a Class A CDL from Maine. His that this patient, Thomas Tomasiewicz, holds a Class A CDL from Wisconsin. driving record for the last 3 years shows has sufficient visual abilities, in regard His driving record for the last 3 years no crashes and no convictions for to acuity and visual field, to perform the shows no crashes and no convictions for moving violations in a CMV. task of driving and operating a moving violations in a CMV. commercial vehicle.’’ Mr. Tomasiewicz Miguel A. Sanchez Reginald J. Wuethrich reported that he has driven straight Mr. Sanchez, 33, has had amblyopia trucks for 3 years, accumulating 150,000 Mr. Wuethrich, 46, has a prosthetic in his right eye since childhood. The miles. He holds a Class C operator’s right eye due to a traumatic injury best corrected visual acuity in his right license from Illinois. His driving record sustained in 1982. The best corrected eye is 20/100 and in his left eye, 20/20. for the last 3 years shows no crashes and visual acuity in his left eye is 20/15. Following an examination in 2009, his no convictions for moving violations in Following an examination in 2009, his optometrist noted, ‘‘In my medical a CMV. ophthalmologist noted, ‘‘In my opinion, opinion Miguel has sufficient vision to given the long standing and stable perform the driving tasks required to James E. Vickery nature of his visual condition, there is operate a commercial vehicle.’’ Mr. Mr. Vickery, 39, has had amblyopia in no reason for him to be unable to Sanchez reported that he has driven his left eye since birth. The best perform the duties associated with

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operating a commercial vehicle.’’ Mr. Columbia Ave., Campus Building, Suite 103–202, § 202(c)(1)(B) (31 U.S.C. 3 121 Wuethrich reported that he has driven 2–260, College Park, GA 30337. note). straight trucks for 26 years, In addition, one copy of any This notice shall constitute my accumulating 78,000 miles, and tractor- comments submitted to the FAA must determination, pursuant to the authority trailer combinations for 26 years, be mailed or delivered to Ms. Carol placed in heads of agencies by 5 U.S.C. accumulating 520,000 miles. He holds a Thomas, Interim Airport Director at the App. 2, § 10(d) and vested in me by Class A CDL from Illinois. His driving following address: Airport Road, P.O. Treasury Department Order No. 101–05, record for the last 3 years shows no Drawer 5809, Pinehurst, NC 28374. that the meeting will consist of crashes and no convictions for moving FOR FURTHER INFORMATION CONTACT: discussions and debates of the issues violations in a CMV. Rusty Nealis, Program Manager, Atlanta presented to the Committee by the Secretary of the Treasury and the Request for Comments Airports District Office, 1701 Columbus Ave, Campus Bldg., Suite 2–260, making of recommendations of the In accordance with 49 U.S.C. 31136(e) College Park, GA 30337, (404) 305– Committee to the Secretary, pursuant to and 31315, FMCSA requests public 7142. The application may be reviewed Public Law 103–202, § 202(c)(1)(B). comment from all interested persons on in person at this same location. Thus, this information is exempt from the exemption petitions described in disclosure under that provision and 5 SUPPLEMENTARY INFORMATION: The FAA this notice. The Agency will consider all U.S.C. 552b(c)(3)(B). In addition, the is reviewing a request by the Moore comments received before the close of meeting is concerned with information County Airport Authority to release 27.7 business February 12, 2010. Comments that is exempt from disclosure under 5 acres of surplus property at the Moore will be available for examination in the U.S.C. 552b(c)(9)(A). The public interest County Airport. The surplus property docket at the location listed under the requires that such meetings be closed to will be used as right-of-way for the ADDRESSES section of this notice. The the public because the Treasury newly constructed roadway associated Agency will file comments received Department requires frank and full with recent airport development. after the comment closing date in the advice from representatives of the Any person may inspect the request public docket, and will consider them to financial community prior to making its in person at the FAA office listed above the extent practicable. final decisions on major financing FOR FURTHER INFORMATION In addition to late comments, FMCSA under operations. Historically, this advice has will also continue to file, in the public CONTACT. been offered by debt management In addition, any person may, upon docket, relevant information that advisory committees established by the request, inspect the request, notice and becomes available after the comment several major segments of the financial other documents germane to the request closing date. Interested persons should community. When so utilized, such a in person at the Moore County Airport, monitor the public docket for new committee is recognized to be an 7825 Aviation Drive, Carthage, NC material. advisory committee under 5 U.S.C. App. 28327. Issued on: January 6, 2010. 2, § 3. Issued in Atlanta, Georgia on January 4, Although the Treasury’s final Larry W. Minor, 2010. announcement of financing plans may Associate Administrator for Policy and Scott L. Seritt, not reflect the recommendations Program Development. Manager, Atlanta Airports District Office, provided in reports of the Committee, [FR Doc. 2010–412 Filed 1–12–10; 8:45 am] Southern Region. premature disclosure of the Committee’s BILLING CODE 4910–EX–P [FR Doc. 2010–397 Filed 1–12–10; 8:45 am] deliberations and reports would be BILLING CODE 4910–13–P likely to lead to significant financial speculation in the securities market. DEPARTMENT OF TRANSPORTATION Thus, this meeting falls within the Federal Aviation Administration DEPARTMENT OF THE TREASURY exemption covered by 5 U.S.C. 552b(c)(9)(A). Notice of Opportunity for Public Departmental Offices; Debt Treasury staff will provide a technical Comment on Surplus Property Release Management Advisory Committee briefing to the press on the day before at Moore County Airport, Pinehurst/ Meeting the Committee meeting, following the Southern Pines, NC release of a statement of economic Notice is hereby given, pursuant to 5 conditions, financing estimates and AGENCY: Federal Aviation U.S.C. App. 2, § 10(a)(2), that a meeting technical charts. This briefing will give Administration (FAA), DOT. will be held at the Hay-Adams Hotel, the press an opportunity to ask ACTION: Notice. 16th Street and Pennsylvania Avenue, questions about financing projections NW., Washington, DC, on February 2, and technical charts. The day after the SUMMARY: Under the provisions of Title 2010 at 8:30 a.m. of the following debt Committee meeting, Treasury will 49, U.S.C. Section 47153(d), notice is management advisory committee: release the minutes of the meeting, any being given that the FAA is considering Treasury Borrowing Advisory charts that were discussed at the a request from the Moore County Committee of The Securities Industry meeting, and the Committee’s report to Airport Authority to waive the and Financial Markets Association. the Secretary. requirement that a 27.7 acre parcel of The agenda for the meeting provides The Office of Debt Management is surplus property, located at the Moore for a charge by the Secretary of the responsible for maintaining records of County Airport, be used for aeronautical Treasury or his designate that the debt management advisory committee purposes. Committee discuss particular issues and meetings and for providing annual DATES: Comments must be received on conduct a working session. Following reports setting forth a summary of or before February 12, 2010. the working session, the Committee will Committee activities and such other ADDRESSES: Comments on this notice present a written report of its matters as may be informative to the may be mailed or delivered in triplicate recommendations. The meeting will be public consistent with the policy of 5 to the FAA at the following address: closed to the public, pursuant to 5 U.S.C. 552(b). The Designated Federal Atlanta Airports District Office, 1701 U.S.C. App. 2, § 10(d) and Public Law Officer or other responsible agency

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official who may be contacted for Street, NW., #10235, Washington, DC • Designates check-off boxes on the additional information is Fred 20503, or by fax to (202) 395–6974. relevant forms with the opt out notice; • Pietrangeli, Deputy Director for Office of FOR FURTHER INFORMATION CONTACT: You Includes a reply form with the opt Debt Management (202) 622–1876 can request additional information or a out notice; • Dated: January 6, 2010. copy of the collection from Mary H. Provides electronic means to opt out; or Fred Pietrangeli, Gottlieb, OCC Clearance Officer, (202) • 874–5090, Legislative and Regulatory Provides a toll-free number to opt Deputy Director, Office of Debt Management. out. [FR Doc. 2010–271 Filed 1–12–10; 8:45 am] Activities Division, Office of the Comptroller of the Currency, 250 E §§ 40.10(a)(2) and 40.10(c)— BILLING CODE 4810–25–M Street, SW., Washington, DC 20219. Consumers must take affirmative actions to exercise their rights to prevent SUPPLEMENTARY INFORMATION: The OCC financial institutions from sharing their DEPARTMENT OF THE TREASURY is proposing to extend OMB approval of information with nonaffiliated parties— the following information collection: • Opt out—Consumers may direct Office of the Comptroller of the Title: Privacy of Consumer Financial Currency that the bank not disclose nonpublic Information (12 CFR part 40). personal information about them to a OMB Control No.: 1557–0216. Agency Information Collection nonaffiliated third party, other than Description: This submission covers permitted by §§ 40.13–40.15 Activities: Submission for OMB an existing regulation and involves no Review; Comment Request • Partial opt out—Consumer may also change to the regulation or to the exercise partial opt out rights by AGENCY: Office of the Comptroller of the information collection requirements. selecting certain nonpublic personal Currency (OCC), Treasury. The OCC requests only that OMB information or certain nonaffiliated ACTION: Notice and request for comment. approve its revised estimates. third parties with respect to which the The information collection consumer wishes to opt out. SUMMARY: The OCC, as part of its requirements in part 40 are as follows: §§ 40.7(f) and (g)—Reporting continuing effort to reduce paperwork § 40.4(a)—Disclosure (institution)— (consumer)—Consumers may exercise and respondent burden, invites the Initial privacy notice to consumers continuing right to opt out—Consumer general public and other Federal requirement—A bank must provide a may opt out at any time—A consumer agencies to take this opportunity to clear and conspicuous notice that may exercise the right to opt out at any comment on a continuing information accurately reflects its privacy policies time. A consumer’s direction to opt out collection, as required by the Paperwork and practices to customers and is effective until the consumer revokes Reduction Act of 1995. An agency may consumers. it in writing or, if the consumer agrees, not conduct or sponsor, and a § 40.5(a)—Disclosure (institution)— electronically. When a customer respondent is not required to respond Annual privacy notice to customers relationship terminates, the customer’s to, an information collection unless it requirement—A bank must provide a displays a currently valid Office of opt out direction continues to apply. clear and conspicuous notice to Type of Review: Extension of a Management and Budget (OMB) control customers that accurately reflects its currently approved collection. number. The OCC is soliciting comment privacy policies and practices not less Affected Public: Businesses or other concerning its information collection than annually during the continuation for-profit; individuals. titled, ‘‘Privacy of Consumer Financial of the customer relationship. Estimated Annual Number of Information (12 CFR part 40).’’ The OCC § 40.8—Disclosure (institution)— Institution Respondents: Initial Notice, is also giving notice that it has sent the Revised privacy notices—If a bank 11; Annual Notice and Change in collection to OMB for review. wishes to disclose information in a way Terms, 1,625; Opt-out Notice, 813. DATES: You should submit written that is inconsistent with the notices Estimated Average Time per Response comments by February 12, 2010. previously given to a consumer, the Per Institution: Initial Notice, 80 hours; ADDRESSES: Communications Division, bank must provide consumers with a Annual Notice and Change in Terms, 8 Office of the Comptroller of the clear and conspicuous revised notice of hours; Opt-out Notice, 8 hours. Currency, Mailstop 2–3, Attention: the bank’s policies and procedures and Estimated Subtotal Annual Burden 1557–0216, 250 E Street, SW., a new opt out notice. Hours for Institutions: 20,384 hours. Washington, DC 20219. In addition, § 40.7(a)—Disclosure (institution)— Estimated Annual Number of comments may be sent by fax to (202) Form of opt out notice to consumers; opt Consumer Respondents: 15,028,802. 874–5274, or by electronic mail to out methods—Form of opt out notice— Estimated Average Time per Consumer [email protected]. You may If a bank is required to provide an opt- Response: 0.25 hours. personally inspect and photocopy the out notice under § 40.10(a), it must Estimated Subtotal Annual Burden comments at the OCC, 250 E Street, provide a clear and conspicuous notice Hours for Consumers: 3,757,200.5 SW., Washington, DC 20219. For to each of its consumers that accurately hours. security reasons, the OCC requires that explains the right to opt out under that Estimated Total Annual Burden visitors make an appointment to inspect section. The notice must state: Hours: 3,777,584.5 hours. comments. You may do so by calling • That the bank discloses or reserves The OCC issued a 60-day Federal (202) 874–4700. Upon arrival, visitors the right to disclose nonpublic personal Register notice on November 3, 2009. 74 will be required to present valid information about its consumer to a FR 56923. No comments were received. government-issued photo identification nonaffiliated third party; Comments continue to be invited on: and to submit to security screening in • That the consumer has the right to (a) Whether the collection of order to inspect and photocopy opt out of that disclosure; and information is necessary for the proper comments. • A reasonable means by which the performance of the functions of the Additionally, you should send a copy consumer may exercise the opt out OCC, including whether the information of your comments by mail to OCC Desk right. has practical utility; (b) The accuracy of Officer, 1557–0216, U.S. Office of A bank provides a reasonable means the OCC’s estimate of the information Management and Budget, 725, 17th to exercise an opt out right if it: collection burden; (c) Ways to enhance

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the quality, utility, and clarity of the or other forms of information Dated: January 7, 2010. information to be collected; (d) Ways to technology; and (e) Estimates of capital Michele Meyer, minimize the burden of the collection or start-up costs and costs of operation, Assistant Director, Legislative and Regulatory on respondents, including through the maintenance, and purchase of services Activities Division. use of automated collection techniques to provide information. [FR Doc. 2010–414 Filed 1–12–10; 8:45 am] BILLING CODE 4810–33–P

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Part II

Department of Health and Human Services Centers for Medicare & Medicaid Services

42 CFR Parts 412, et al. Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule

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DEPARTMENT OF HEALTH AND 2. By regular mail. You may mail CMS considers the comments promptly. HUMAN SERVICES written comments to the following Comments mailed or delivered to the address ONLY: Centers for Medicare & CMS headquarters may not be readily Centers for Medicare & Medicaid Medicaid Services, Department of accessible for review if CMS employees Services Health and Human Services, Attention: are not able to report to work at the CMS CMS–0033–P, P.O. Box 8013, Baltimore, headquarters. CMS wishes to ensure 42 CFR Parts 412, 413, 422, and 495 MD 21244–8013. that public comments on its regulations Please allow sufficient time for mailed and PRA notices are promptly displayed [CMS–0033–P] comments to be received before the on the regulations.gov Web site for the close of the comment period. public to review. To ensure that RIN 0938–AP78 3. By express or overnight mail. You comments are displayed as quickly as Medicare and Medicaid Programs; may send written comments to the possible, we request that the public use Electronic Health Record Incentive following address only: Centers for only one public comment submission Program Medicare & Medicaid Services, option. These efforts are intended to Department of Health and Human ensure that CMS operations continue AGENCY: Centers for Medicare & Services, Attention: CMS–0033–P, Mail even during an emergency and that Medicaid Services (CMS), HHS. Stop C4–26–05, 7500 Security consideration of public comments and ACTION: Proposed rule. Boulevard, Baltimore, MD 21244–1850. access to those comments occur timely. 4. By hand or courier. If you prefer, For information on viewing public SUMMARY: This proposed rule would you may deliver (by hand or courier) comments, see the beginning of the implement the provisions of the your written comments before the close SUPPLEMENTARY INFORMATION section. American Recovery and Reinvestment of the comment period to either of the Act of 2009 (ARRA) (Pub. L. 111–5) that following addresses: FOR FURTHER INFORMATION CONTACT: provide incentive payments to eligible a. For delivery in Washington, DC— Elizabeth Holland, (410) 786–1309, EHR professionals (EPs) and eligible Centers for Medicare & Medicaid incentive program issues. Edward hospitals participating in Medicare and Services, Department of Health and Gendron, (410) 786–1064, Medicaid Medicaid programs that adopt and Human Services, Room 445–G, Hubert incentive payment issues. Jim Hart, meaningfully use certified electronic H. Humphrey Building, 200 (410) 786–9520, Medicare fee for service health record (EHR) technology. The Independence Avenue, SW., payment issues. Terry Kay, (410) 786– proposed rule would specify the—initial Washington, DC 20201. 4493, Medicare fee for service payment criteria an EP and eligible hospital must (Because access to the interior of the issues. meet in order to qualify for the incentive Hubert H. Humphrey Building is not SUPPLEMENTARY INFORMATION: payment; calculation of the incentive readily available to persons without payment amounts; payment adjustments Federal government identification, Submitting Comments: We welcome under Medicare for covered professional commenters are encouraged to leave comments from the public on all issues services and inpatient hospital services their comments in the CMS drop slots set forth in this proposed rule to assist provided by EPs and eligible hospitals located in the main lobby of the us in fully considering issues and failing to meaningfully use certified building. A stamp-in clock is available developing policies. You can assist us EHR technology; and other program for persons wishing to retain a proof of by referencing the file code (CMS–0033– participation requirements. Also, as filing by stamping in and retaining an P) and the specific ‘‘issue identifier’’ that required by ARRA the Office of the extra copy of the comments being filed.) precedes the section on which you National Coordinator for Health b. For delivery in Baltimore, MD— choose to comment. Information Technology (ONC) will be Centers for Medicare & Medicaid Inspection of Public Comments: All issuing a closely related interim final Services, Department of Health and comments received before the close of rule that specifies the Secretary’s Human Services, 7500 Security the comment period are available for adoption of an initial set of standards, Boulevard, Baltimore, MD 21244–1850. viewing by the public, including any If you intend to deliver your implementation, specifications, and personally identifiable or confidential comments to the Baltimore address, certification criteria for electronic health business information that is included in please call telephone number (410) 786– records. ONC will also be issuing a a comment. We post all comments 9994 in advance to schedule your notice of proposed rulemaking on the received before the close of the arrival with one of our staff members. process for organizations to conduct the comment period on the following Web Comments mailed to the addresses certification of EHR technology. site as soon as possible after they have indicated as appropriate for hand or been received: http:// DATES: To be assured consideration, courier delivery may be delayed and www.regulations.gov. Follow the search comments must be received at one of received after the comment period. the addresses provided below, no later Submission of comments on instructions on that Web site to view than 5 p.m. on March 15, 2010. paperwork requirements. You may public comments. ADDRESSES: In commenting, please refer submit comments on this document’s Comments received timely will also to file code CMS–0033–P. Because of paperwork requirements by following be available for public inspection as staff and resource limitations, we cannot the instructions at the end of the they are received, generally beginning accept comments by facsimile (FAX) ‘‘Collection of Information approximately 3 weeks after publication transmission. Requirements’’ section in this document. of a document, at the headquarters of You may submit comments in one of In the event that CMS must limit the the Centers for Medicare & Medicaid four ways (please choose only one of the number of employees reporting for duty Services, 7500 Security Boulevard, ways listed): during an emergency or for other Baltimore, Maryland 21244, Monday 1. Electronically. You may submit reasons, submitting comments on CMS through Friday of each week from 8:30 electronic comments on this regulation regulations and Paperwork Reduction a.m. to 4 p.m. To schedule an to http://www.regulations.gov. Follow Act (PRA) notices via appointment to view public comments, the instructions on the home page. www.regulations.gov will ensure that phone 1–800–743–3951.

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Acronyms Table of Contents b. Methods for Demonstration of the Stage 1 Criteria of Meaningful Use ARRA American Recovery and I. Background 5. Data Collection for Online Posting, Reinvestment Act of 2009 A. Overview of the HITECH Programs Program Coordination and Accurate CAH Critical Access Hospital Created by the American Recovery and Payments CAHPS Consumer Assessment of Reinvestment Act of 2009 a. Online Posting Healthcare Providers and Systems B. Statutory Basis for the Medicare & b. Program Election Between Medicare CCN CMS Certification Numbers Medicaid EHR Incentive Programs FFS/MA and Medicaid for EPs CHIP Children’s Health Insurance Program II. Provisions of the Proposed Regulations c. Data To Be Collected CHIPRA Children’s Health Insurance A. Definitions Across the Medicare FFS, 6. Hospital-Based Eligible Professionals Program Reauthorization Act of 2009 Medicare Advantage, and Medicaid 7. Interaction With Other Programs CMS Centers for Medicare & Medicaid Programs B. Medicare Fee-for-Service Incentives Services 1. Definitions 1. Incentive Payments for Eligible CY Calendar Year a. Certified Electronic Health Record (EHR) Professionals EHR Electronic Health Record Technology a. Definitions EP Eligible Professionals b. Qualified Electronic Health Record b. Incentive Payment Limits EPO Exclusive Provider Organization c. Payment Year c. Increase in Incentive Payment for EPs FACA Federal Advisory Committee Act d. First, Second, Third, Fourth, Fifth and who Predominantly Furnish Services in FFP Federal Financial Participation Sixth Payment Year a Geographic Health Professional FFS Fee-For-Service e. EHR Reporting Period Shortage Area FQHC Federally Qualified Health Center f. Meaningful EHR User d. Form and Timing of Payment FTE Full-Time Equivalent 2. Definition of Meaningful Use e. Payment Adjustment Effective in CY FY Fiscal Year a. Background 2015 and Subsequent Years for EPs Who FFY Federal Fiscal Year b. Common Definition of Meaningful Use Are Not Meaningful Users of Certified HEDIS Healthcare Effectiveness Data and Under Medicare and Medicaid EHR Technology Information Set c. Considerations in Defining Meaningful 2. Incentive Payments for Hospitals HHS Department of Health and Human Use a. Definition of Eligible Hospital for d. Stage 1 Criteria for Meaningful Use Medicare Services 3. Sections 4101(a) and 4102(a)(1) of b. Incentive Payment Calculation for HIE Health Information Exchanges HITECH Act: Reporting on Clinical Eligible Hospitals HIT Health Information Technology Quality Measures Using EHR by EPs and c. Medicare Share HIPPA Health Insurance Portability and All Eligible Hospitals d. Charity Care Accountability Act of 1996 a. General e. Transition Factor HITECH Health Information Technology for b. Requirements for the Submission of f. Duration and Timing of Incentive Economic and Clinical Health Act Clinical Quality Measures by EPs and Payments HMO Health Maintenance Organization Eligible Hospitals g. Incentive Payment Adjustment Effective HOS Health Outcomes Survey c. Statutory Requirements and Other in Federal FY 2015 and Subsequent HPSA Health Professional Shortage Area Considerations for the Proposed Years for Eligible Hospitals Who Are Not HRSA Health Resource Services Selection of Clinical Quality Measures Meaningful EHR Users Administration Proposed for Electronic Submission by 3. Incentive Payments for Critical Access IAPD Implementation Advanced Planning EPs or Eligible Hospitals Hospitals Document (1) Statutory Requirements for the a. Definition of CAHs for Medicare IPA Independent Practice Association Selection of Clinical Quality Measures b. Current Medicare Payment of IHS Indian Health Services Proposed for Electronic Submission by Reasonable Cost for CAHs IT Information Technology EPs and Eligible Hospitals c. Changes made by the HITECH Act MA Medicare Advantage (2) Other Considerations for the Proposed d. Incentive Payment Calculation for CAHs MAC Medicare Administrative Contractor Selection of Clinical Quality Measures e. Reduction of Reasonable Cost Payment MCO Medicaid Managed Care Organization for Electronic Submission by EPs and in FY 2015 and Subsequent Years for MITA Medicaid Information Technology Eligible Hospitals CAHs That Are Not Meaningful EHR Architecture d. Proposed Clinical Quality Measures for Users MMIS Medicaid Management Information Electronic Submission Using Certified 4. Process for Making Incentive Payments Systems EHR Technology by Eligible Under the Medicare FFS Program MSA Medical Savings Account Professionals a. Incentive Payments to EPs NCQA National Committee for Quality e. Clinical Quality Measures Reporting b. Incentive Payments to Eligible Hospitals Assurance Criteria for Eligible Professionals c. Incentive Payments to CAHs NCVHS National Committee on Vital and f. Proposed Clinical Quality Measures for d. Payment Accounting under Medicare Health Statistics Electronic Submission by Eligible C. Medicare Advantage Organization NPI National Provider Identifier Hospitals Incentive Payments ONC Office of the National Coordinator for g. Request for Public Comment on Potential 1. Definitions Health Information Technology Measures for Eligible Professionals and a. Qualifying MA Organization PAHP Prepaid Ambulatory Health Plan Eligible Hospitals in 2013 Payment Year b. Qualifying MA Eligible Professional PAPD Planning Advanced Planning and Subsequent Years c. Qualifying MA-Affiliated Eligible Document h. Proposed Reporting Method for Clinical Hospital PIHP Prepaid Inpatient Health Plan Quality Measures 2. Identification of Qualifying MA PFFS Private Fee-For-Service (1) Reporting Method for 2011 Payment Organizations, MA EPs, and MA- PHO Physician Hospital Organization Year Affiliated Eligible Hospitals PHS Public Health Service (2) Reporting Method for 2012 3. Computation of Incentives to Qualifying POS Place of Service i. Alternative Reporting Methods for MA Organizations for MA EPs and PPO Preferred Provider Organization Clinical Quality Measures Hospitals PSO Provider Sponsored Organization j. Proposed Reporting Criteria for Eligible 4. Timeframe for Payment RHC Rural Health Clinic Professionals and Eligible Hospitals 5. Avoiding Duplicate Payment RPPO Regional Preferred Provider k. Addressing Dually-Eligible Medicare/ 6. Meaningful User Attestation Organization Medicaid Beneficiaries Under HITECH 7. Posting on Web site and Limitation on SMHP State Medicaid Health Information 4. Demonstration of Meaningful Use Review Technology Plan a. Common Methods of Demonstration in 8. Limitation on Review TIN Tax Identification Number Medicare and Medicaid 9. Conforming Changes

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10. Payment Adjustment and Future E. ICRs Regarding Meaningful User technology and qualified EHRs. Rulemaking Attestation (§ 495.210) Expanded use of health information D. Medicaid Incentives F. ICRs Regarding Incentive Payments to technology (HIT) and EHRs will 1. Overview of Health Information Qualifying MA Organizations for MA- improve the quality and value of Technology in Medicaid Eligible Professionals and Hospitals 2. General Medicaid Provisions (§ 495.220) American health care. These provisions, 3. Identification of Qualifying Medicaid G. ICRs Regarding Process for Payments together with Title XIII of Division A of EPs and Eligible Hospitals (§ 495.312) ARRA, may be cited as the Health a. Overview H. ICRs Regarding Activities Required to Information Technology for Economic b. Program Participation Receive an Incentive Payment and Clinical Health Act’’ or the ‘‘HITECH 1. Acute Care Hospitals (§ 495.314) Act.’’ The incentive payments for 2. Children’s Hospitals I. ICRs Regarding State Monitoring and adoption and meaningful use of HIT and c. Medicaid Professionals Program Reporting Regarding Activities Required qualified EHRs are part of a broader Eligibility To Receive an Incentive Payment d. Calculating Patient Volume (§ 495.316) effort under the HITECH Act to Requirements J. ICRs Regarding State Responsibilities for accelerate the adoption of HIT and e. Entities Promoting the Adoption of Receiving FFP (§ 495.318) utilization of qualified EHRs. We are Certified EHR Technology K. ICRs Regarding Prior Approval developing the incentive programs 4. Computation of Amount Payable to Conditions (§ 495.324) which are outlined in Division B, Title Qualifying Medicaid EPs and Eligible L. ICRs Regarding Termination of Federal IV of the HITECH Act and these Hospitals Financial Participation (FFP) for Failure programs are the keys to inducing (1) General Overview To Provide Access to Information providers to actively utilize HIT. (2) Average Allowable Costs (§ 495.330) (3) Net Average Allowable Costs M. ICRs Regarding State Medicaid Agency EPs and eligible hospitals qualify for (4) Payments for Medicaid Eligible and Medicaid EP and Hospital Activities the EHR incentive payments if, among Professionals (§ 495.332 Through § 495.338) other requirements, they meaningfully (5) Basis for Medicaid EHR Incentive N. ICRs Regarding Access to Systems and use certified EHR technology. This Program First Payment Year and Records (§ 495.342) proposed rule sets forth a proposed Subsequent Payment Years O. ICRs Regarding Procurement Standards definition of ‘‘meaningful use of (i) Medicaid EP Who Begins Adopting, (§ 495.344) certified EHR technology.’’ Section Implementing or Upgrading Certified P. ICRs Regarding State Medicaid Agency 13101 of the HITECH Act adds a new EHR Technology in the First Year Attestations (§ 495.346) section 3000 to the Public Health (ii) Medicaid EP who has Already Q. ICRs Regarding Reporting Requirements Adopted, Implemented or Upgraded (§ 495.348) Service Act (PHSA), which defines Certified EHR Technology and R. ICRs Regarding Retroactive Approval of ‘‘certified EHR technology’’ as a Meaningfully Uses EHR Technology FFP With an Effective Date of February qualified EHR that has been properly b. Payment Methodology for Eligible 18, 2009 (§ 495.358) certified as meeting standards adopted Hospitals S. ICRs Regarding Financial Oversight and under section 3004 of the PHSA. CMS c. Alternative and Optional Early State Monitoring Expenditures (§ 495.362) and ONC have been working closely to Implementation to Make Incentive T. ICRs Regarding Appeals Process for a ensure that the definition of meaningful Payments for Adopting, Implementing or Medicaid Provider Receiving Electronic use of certified EHR technology and the Upgrading Certified EHR Technology Health Record Incentive Payments standards for certified EHR technology d. Process for Making and Receiving (§ 495.366) Medicaid Incentive Payments IV. Response to Comments are coordinated. ‘‘Meaningful use’’ is a e. Avoiding Duplicate Payment V. Regulatory Impact Analysis term defined by CMS and describes the f. Flexibility to Alternate Between A. Overall Impact use of HIT that furthers the goals of Medicare and Medicaid Incentive B. Regulatory Flexibility Analysis information exchange among health care Payment Program One Time C. Small Rural Hospitals professionals. In an upcoming interim g. One State Selection D. Unfunded Mandates Reform Act final rule, ONC will identify the initial 5. National Level Repository and State Data E. Federalism set of standards and implementation Collection F. Anticipated Effects specifications that EHR technology must 6. Collection of Information Related to the G. HITECH Impact Analysis implement, as well as the certification Eligible Professional’s National Provider H. Accounting Statement Identifier and the Tax Identification criteria that will be used to certify EHR Number (TIN) I. Background technology, and will further define the ‘‘ ’’ 7. Activities Required to Receive Incentive A. Overview of the HITECH Programs term certified EHR technology. In a Payments related proposed rule, the Department Created by the American Recovery and a. General Overview will propose the development of a Reinvestment Act of 2009 b. Definitions Related to Certified EHR certification program for health IT. Technology and Adopting, Implementing The American Recovery and Specifically, we have sought to ensure or Upgrading Such Technology Reinvestment Act of 2009 (ARRA) (Pub. that the definition of meaningful use of (1) Certified EHR Technology L. 111–5) was enacted on February 17, certified EHR technology does not (2) Adopting, Implementing or Upgrading 2009. ARRA includes many measures to c. Other General Terminology require EPs and eligible hospitals to III. Collection of Information Requirements modernize our nation’s infrastructure, perform functionalities for which A. ICRs Regarding Demonstration of enhance energy independence, expand standards have not been recognized or Meaningful Use Criteria (§ 495.8) educational opportunities, provide tax established. Similarly, the functionality B. ICRs Regarding Participation relief, and preserve and improve of certified EHR technology should Requirements for EPs, Eligible Hospitals, affordable health care. Title IV of enable and advance the definition of and Qualifying CAHs (§ 495.10) Division B of ARRA amends Titles XVIII meaningful use. C. ICRs Regarding Identification of and XIX of the Social Security Act (the We urge those interested in this Qualifying MA Organizations, MA–EPs Act) by establishing incentive payments and MA-Affiliated Eligible Hospitals proposed rule to also review the ONC (§ 495.202) to eligible professionals (EPs) and interim final rule with comment and the D. ICRs Regarding Incentive Payments to eligible hospitals to promote the related proposed rule when they are Qualifying MA Organizations for MA– adoption and meaningful use of published later this year and to visit EPs and Hospitals (§ 495.204) interoperable health information http://healthit.hhs.gov and http://

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www.cms.hhs.gov/Recovery/ HITECH Act amends section 1814(l) of meaningful use of certified EHR 11_HealthIT.asp#TopOfPage for more the Act to provide for a downward technology. Eligible hospitals may information on the efforts at the payment adjustment for hospital participate in either one of the Medicare Department of Health and Human services provided by CAHs that are not (FFS or MA) programs and the Medicaid Services (HHS) to advance HIT meaningful users of certified EHR program, assuming they meet each initiatives. technology for cost reporting periods program’s eligibility requirements, beginning in FY 2015. Section 4102(c) B. Statutory Basis for the Medicare & which vary across programs. In certain of the HITECH Act adds a new Medicaid EHR Incentive Programs cases, the HITECH Act has used nearly subsection (m) to section 1853 of the Section 4101(a) of the HITECH Act identical or identical language in Act to provide incentive payments to defining terms that are used in the adds a new subsection (o) to section MA organizations for certain affiliated Medicare FFS, MA, and Medicaid 1848 of the Act. Section 1848(o) of the hospitals that meaningfully use certified Act establishes incentive payments for EHR technology to address avoidance of programs, including such terms as the meaningful use of certified EHR duplicate payments, and to make a ‘‘hospital-based EPs’’ and ‘‘certified EHR technology by EPs participating in the downward adjustment to payments to technology.’’ In these cases, we seek to original Medicare program or MA organizations for inpatient hospital create as much commonality between hereinafter referred to as Medicare Fee- services provided by its affiliated the three programs as possible and have for-Service (FFS) program beginning in hospitals that are not meaningful users structured this proposed rule based on calendar year (CY) 2011. Section of certified EHR technology beginning that premise by beginning with those 4101(b) of the HITECH Act also adds a in FY 2015. provisions that cut across the three new paragraph (7) to section 1848(a) of Section 4103 of the HITECH Act programs before moving on to discuss the Act. Section 1848(a)(7) of the Act provides for implementation funding for the provisions specific to Medicare FFS, provides that beginning in CY 2015, EPs the EHR incentives program under MA and Medicaid. who are not meaningful users of Medicare. certified EHR technology will receive Section 4201 of the HITECH Act A. Definitions Across the Medicare FFS, less than 100 percent of the fee schedule amends section 1903 of the Act to Medicare Advantage, and Medicaid for their professional services. Section provide 100 percent Federal financial Programs 4101(c) of the HITECH Act adds a new participation (FFP) to States for subsection (l) to section 1853 of the Act incentive payments to certain eligible Title IV, Division B of the HITECH to provide incentive payments to providers participating in the Medicaid Act establishes incentive payments Medicare Advantage (MA) organizations program to purchase, implement, and under the Medicare and Medicaid for their affiliated EPs who operate (including support services and programs for certain professionals and meaningfully use certified EHR training for staff) certified EHR hospitals that meaningfully use certified technology and meet certain other technology and 90 percent FFP for State EHR technology. Under Medicare, these requirements, and a requirement to administrative expenses related to the incentive payments may be made to make a downward adjustment to program outlined in 1903(t) of the Act. qualifying professionals, hospitals, and Medicare payments to MA organizations Section 4201(a)(2) of the HITECH Act Medicare Advantage (MA) organizations for professional services provided by adds a new subsection (t) to section on behalf of certain MA affiliated any of their affiliated EPs who are not 1903 of the Act to establish a program physicians and hospitals. We refer to meaningful users of certified EHR with input from the States to provide the incentive payments made under the technology, beginning in 2015, and incentives for the adoption and original Medicare program as the avoids duplicate of payments from the subsequent meaningful use of certified Medicare FFS EHR incentive program. MA EHR incentive program under this EHR technology for providers We refer to the incentive payments section and the FFS EHR incentive participating in the Medicaid program. made to qualifying MA organizations as program under section 1848(o)(1)(A). Section 4102(a) of the HITECH Act II. Provisions of the Proposed the MA EHR incentive program, and the adds a new subsection (n) to section Regulations incentive payments made under 1886 of the Act. Section 1886(n) of the We propose to add a new part 495 to Medicaid as the Medicaid EHR Act establishes incentive payments for title 42 of the Code of Federal incentive program. When referring to the meaningful use of certified EHR Regulations to implement the provisions Medicare EHR incentive program, we technology by subsection (d) hospitals, discussed in this section of the are referring to both the Medicare FFS as defined under section 1886(d)(1)(B) proposed rule related to certified EHR EHR and the MA EHR incentive of the Act, participating in Medicare technology for providers participating in programs. FFS program beginning in Federal fiscal either the Medicare program or the 1. Definitions year (FY) 2011. Section 4102(b)(1) of the Medicaid program. HITECH Act amends section The HITECH Act creates incentives in Sections 4101, 4102, and 4202 of the 1886(b)(3)(B) of the Act to provide that, the Medicare Fee-for-Service (FFS), HITECH Act use many identical or beginning in FY 2015, subsection (d) Medicare Advantage (MA), and similar terms. In this section of the hospitals that are not meaningful users Medicaid programs for demonstrating preamble, we discuss terms for which of certified EHR technology will receive meaning EHR use and payment we are proposing uniform definitions a reduced annual payment update. adjustments in the Medicare FFS and for the Medicare FFS, Medicare Section 4102(b)(2) of the HITECH Act MA programs for not demonstrating Advantage, and Medicaid EHR incentive amends section 1814(l) of the Act to meaningful EHR use. The three programs. These definitions would be provide an incentive payment to critical incentive programs contain many access hospitals (CAHs) who common elements and certain included in part 495 subpart A of the meaningfully use certified EHR provisions of the HITECH Act encourage regulations. For definitions specific to technology based on the hospitals’ avoiding duplication of payments, an individual program, the definition is reasonable cost beginning in FY 2011. In reporting, and other requirements, set forth and discussed in the applicable addition, section 4102(a)(2) of the particularly in the area of demonstrating EHR incentive program section.

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a. Certified Electronic Health Record meet the definition of a qualified of the Act), rather than ‘‘payment year.’’ (EHR) Technology electronic health record. This term will For the same reasons expressed above The incentive payments are available be defined by ONC in its upcoming for EPs, and because hospitals will have to EPs (non-hospital-based physicians, interim final rule, and we propose to the opportunity to simultaneously as defined in section 1861(r) of the Act, use the definition of qualified electronic participate in both the Medicare and who either receive reimbursement for health record adopted by ONC. Medicaid EHR incentive programs, we propose a common definition of services under the Medicare FFS c. Payment Year ‘‘ ’’ ‘‘ ’’ program or have an employment or payment year and year of payment Under section 1848(o)(1)(A)(i) of the for both programs. For purposes of the contractual relationship with a Act, as added by section 4101(a) of the qualifying MA organization meeting the incentive payments made to eligible HITECH Act, the Medicare FFS EHR hospitals under the Medicare FFS, MA criteria under section 1853(l)(2) of the incentive payment is available to EPs for and Medicaid EHR incentive programs, Act; or healthcare professionals meeting a ‘‘payment year.’’ Section 1848(o)(1)(E) we propose to define payment year and the definition of ‘‘eligible professional’’ of the Act defines the term ‘‘payment year of payment at § 495.4, consistent under section 1903(t)(3)(B) of the Act as year’’ as a year beginning with 2011. with the statutory definition, as ‘‘any well as the patient-volume and non- While the HITECH Act does not use the fiscal year beginning with 2011’’. (The hospital-based criteria of section term, ‘‘payment year,’’ for the Medicaid only exception to this rule, is that in 1903(t)(2)(A) of the Act) and eligible EHR incentive program, it does use the certain cases, Medicaid eligible hospitals (subsection (d) hospitals as term ‘‘year of payment’’ throughout hospitals would be able to participate in defined under subsection 1886(d)(1)(B) section 1903(t) of the Act, for example, the Medicaid EHR incentive program of the Act that either receive at sections 1903(t)(3)(C), 1903(t)(4)(A), starting with FY 2010, for adopting, reimbursement for services under the and 1903(t)(6)(C) of the Act. For all EPs, implementing, or upgrading certified Medicare FFS program or are affiliated we are proposing a common definition EHR technology. For further discussion with a qualifying MA organization as for both ‘‘payment year’’ and ‘‘year of of this early participation in the described in section 1853(m)(2) of the payment,’’ as ‘‘any calendar year Medicaid EHR incentive program, we Act; critical access hospitals (CAHs); or beginning with 2011’’ at § 495.4. (The refer readers to section II.D.3.c of this acute care or children’s hospitals only exception to this rule, is that in proposed rule.) described under section 1903(t)(2)(B) of certain cases, Medicaid EPs would be The actual timing of the incentive the Act). Under all three EHR incentive able to participate in the Medicaid EHR payment for a given payment year varies programs, EPs and eligible hospitals incentive program starting with CY depending on which EHR incentive must utilize ‘‘certified EHR technology’’ 2010, for adopting, implementing, or program an EP or an eligible hospital is if they are to be considered eligible for upgrading certified EHR technology. For participating in. Details on the timing of the incentive payments. In the Medicare further discussion of this early incentive payments for a given payment FFS EHR incentive program this participation in the Medicaid EHR year can be found in section II.B.of the requirement for EPs is found in section incentive program, we refer readers to proposed rule for Medicare FFS, section 1848(o)(2)(A)(i) of the Act, as added by section II.D.3.c. of this proposed rule.) II.C. of the proposed rule for MA and section 4101(a) of the HITECH Act, and This definition, which is consistent section II.D. of the proposed rule for for eligible hospitals and CAHs in with the statutory definition of Medicaid. section 1886(3)(A)(i) of the Act, as ‘‘payment year’’ under Medicare FFS, added by section 4102(a) of the HITECH will simplify the EHR incentive d. First, Second, Third, Fourth, Fifth, Act. In the MA EHR incentive program programs for EPs. As discussed later in and Sixth Payment Year this requirement for EPs is found in this preamble, EPs may have the For EPs and eligible hospitals that section 1853(l)(1) of the Act, as added opportunity to participate in either the qualify for EHR incentive payments in by section 4101(c) of the HITECH Act, Medicare or Medicaid incentive a payment year, the amount of the and for eligible hospitals and CAHs, in programs, and once an EP has picked a payment will depend in part on how section 1853(m)(1) of the Act, as added program, they are permitted to make a many previous payment years, if any, an by section 4201(c) of the HITECH Act. one-time switch from one program to EP or eligible hospital received an In the Medicaid EHR incentive program the other. A common definition will incentive payment. We propose to this requirement for EPs and Medicaid allow EPs to more easily understand define the first payment year to mean eligible hospitals is found throughout both programs, and inform decisions the first calendar or Federal fiscal year section 1903(t) of the Act, including in regarding whether they are eligible for, for which an EP or eligible hospital section 1903(t)(6)(C) of the Act, as and/or wish to participate in either receives an incentive payment. added by section 4201(a)(2) of the program. Under section 1886(n)(1) of Likewise, we propose to define the HITECH Act. While certified EHR the Act, as added by section 4102(a) of second, third, fourth, fifth, and sixth technology is a critical component of the HITECH Act, the Medicare FFS EHR payment year, respectively, to mean the the EHR incentive programs, under the incentive payment is available to second, third, fourth, fifth, and sixth authority given to her in the HITECH eligible hospitals and CAHs for a calendar or Federal fiscal year, Act, the Secretary has charged ONC ‘‘payment year.’’ Section 1886(n)(2)(G) of respectively, for which an EP or eligible with developing the criteria and the Act defines the term ‘‘payment year’’ hospital receives an incentive payment. mechanisms for certification of EHR as a fiscal year (FY) beginning in 2011. e. EHR Reporting Period technology. Therefore, ONC will be As hospitals are paid based on the 12- defining certified EHR technology in its month Federal fiscal year, we believe In order to qualify for an incentive upcoming interim final rule and we the reference to a ‘‘fiscal year’’ means the payment under the Medicare incentive propose to use the definition of certified fiscal year beginning on October 1 of the payment program for a payment year, an EHR technology adopted by ONC. prior year and extending to September EP or eligible hospital must 30 of the relevant year. Again, for the meaningfully use certified EHR b. Qualified Electronic Health Record Medicaid EHR incentive program, the technology for the EHR reporting period In order for an EHR technology to be HITECH Act uses the term, ‘‘year of of the relevant payment year. Similarly, eligible for certification it must first payment’’ (see section 1903)(t)(5)(D)(ii) a Medicaid EP or eligible hospital may

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in the first payment year and must in (1) Whether it should vary from one to use CPOE for 80 percent of all orders, subsequent payment years demonstrate payment year to the next; (2) its length; and hospitals for 10 percent of all meaningful use of such technology, in and (3) starting point. We discuss these orders). We believe a period of fewer order to receive a payment. A Medicaid three aspects below. than 90 days would not be adequate to EP or eligible hospital may receive an The first aspect of the EHR reporting create an accurate rate for a given EP or incentive payment in their first payment period discussed is whether it should be eligible hospital. We believe that once year for the adoption, implementation, the same for each payment year. We an EP or hospital has implemented or upgrade of certified EHR technology. believe that there are considerations that certified EHR technology to the point of Although the Medicaid statute does not distinguish the first payment year from being able to comply with our proposed specifically use the term, ‘‘EHR the remaining payment years. The meaningful use criteria for 90 days, it is reporting period,’’ we believe that the foremost being that once an EP or unlikely that they would adjust their Secretary, pursuant to sections eligible hospital begins to meaningfully behavior just because the EHR reporting 1903(t)(6)(C) and 1903(t)(8) of the Act, use certified EHR technology they are period has ended. Beginning in the has the authority to define the period unlikely to stop. As discussed below, in second payment year, an EP or eligible that would be used for demonstrating the first payment year a shorter EHR hospital will already be meaningfully such adoption/implementation/upgrade reporting period would provide more using certified EHR technology so there or meaningful use. flexibility for when an EP or eligible are no limitations on the time available In this proposed rule, we propose a hospital begins to meaningfully use for compliance. definition of EHR Reporting Period for certified EHR technology and still For the first payment year, therefore, purposes of the Medicare and Medicaid qualify for the incentive in the same we propose that the EHR reporting incentive payments under sections year. However, in subsequent years we period will be any continuous 90-day 1848(o), 1853(l)(3), 1886(n), 1853(m)(3), do not see that flexibility still being period within the first payment year. 1814(l) and 1903(t) of the Act. For these required. Therefore, for purposes of the However, beginning in the second sections, the EHR reporting period may incentive payments under sections payment year we see no compelling be any continuous 90-day period within 1848(o), 1853(l)(3), 1886(n), 1853(m)(3), reason not to seek the most robust the first payment year and the entire 1814(l), and 1903(t) of the Act, we verification possible. Therefore for the payment year for all subsequent propose that the length of the EHR second payment year and all subsequent payment years. In future rulemaking, we reporting period be different for the first payment years we propose the EHR will propose a definition of EHR payment year than from all other reporting period be the entire payment Reporting Period for purposes of payment years. We invite interested year. As the length of the EHR reporting Medicare incentive payment parties to comment on this proposal if period is based on the discussed trade- adjustments under sections 1848(a)(7), they believe that the EHR reporting off, we remain open to alternative 1853(l)(4), 1886(b)(3)(B)(ix), 1853(m)(4), period should vary from payment year lengths of time. We invite comments on and 1814(l)(4) of the Act. Unlike the to payment year. the appropriate length for the EHR former group of sections, meaningful With respect to the length of the EHR reporting period. We urge those EHR users that would not be subject to reporting period, we note that there is commenting to either endorse our adjustments would have to be identified an inherent tradeoff between robust proposed initial 90-day period followed prior to the application of the latter verification and time available to by full year EHR reporting periods or to group of sections. Therefore, these two achieve compliance. A longer EHR recommend a specific alternative. groups of sections may have two reporting period provides a more robust With respect to when the EHR different definitions of EHR Reporting verification that an EP or eligible reporting period for a payment year Period. hospital successfully met the definition should begin, there are two For the first payment year only, we of meaningful use of certified EHR considerations. The first is determining propose to define the term EHR technology than a shorter period. the earliest start date available, and the reporting period at § 495.4 to mean any However, it reduces the time available second is the flexibility given to EPs and continuous 90-day period within a for an EP or eligible hospital to reach eligible hospitals to choose their start payment year in which an EP or eligible the point of complying with meaningful date. This aspect is only applicable for hospital successfully demonstrates use and still receive an incentive for a the 90-day EHR reporting period for the meaningful use of certified EHR given payment year. For example, a 90- first payment year. The length of the technology. The EHR reporting period day period would allow an EP until EHR reporting period for the second therefore could be any continuous October 1, 2011 to begin meaningful use payment year and subsequent payment period beginning and ending within the of their certified EHR technology and years dictate that the start date be the relevant payment year. For example, for receive an incentive for payment year first day of the payment year. The payment year 2011, an EHR reporting 2011. A 180-day period (6 months) earliest start date we considered was period of March 13, 2011 to June 11, would move the date upon which the one which would allow an EP or eligible 2011 would be just as valid as an EHR EP must begin meaningful use of their hospital to demonstrate successful reporting period of January 1, 2011 to certified EHR technology forward to July meaningful use of certified EHR April 1, 2011. An example of an 1, 2011. We are concerned that an EHR technology on the first day of the unallowable EHR reporting period reporting period that is shorter than 90 relevant payment year. For example, would be for an EP to begin on days would be insufficient time to allowing an EHR reporting period to November 1, 2011 and finish on January ensure that EPs and eligible hospitals begin as early as July 3, 2010 would 31, 2012. Starting with the second are truly using certified EHR technology allow an eligible hospital to successfully payment year and any subsequent in a meaningful manner consistent with demonstrate meaningful use on October payment years for a given EP or eligible our proposed criteria for meaningful 1, 2010, the first day of FY 2011. We hospital, we propose to define the term use. Moreover, as discussed later in this have chosen not to propose this as the EHR reporting period at § 495.4 to mean proposed rule, we will require EPs and earliest start date. There are significant the entire payment year. hospitals to demonstrate meaningful use barriers created by the timeline in the In defining the EHR reporting period, by meeting certain performance HITECH Act. We anticipate that we will we considered three of its aspects: thresholds (for example, EPs will need not publish a final rule until after March

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2010, with the final rule effective 60 hospitals, critical access hospitals and care; and (3) that, in using certified EHR days after its publication. We do not managed care plans are meaningful technology, the provider submits to the believe this allows enough time for us, users before application of the Medicare Secretary information on clinical quality the vendor community, or the provider payment adjustments (provisions of measures and such other measures community to take advantage of this sections 1848(a)(7), 1853(l)(4), selected by the Secretary. early start date. In addition, as 1886(b)(3)(B)(ix), 1853(m)(4), and Over the last few months, CMS and discussed at sections 1848(o)(2)(B)(iii) 1814(l)(4) of the Act). We will specify ONC have solicited input on defining and 1886(n)(3)(B)(iii) of the Act, the the EHR reporting periods for these meaningful use from both other HITECH Act directs the Secretary to payment adjustment incentives in future government agencies and the public seek to avoid duplicative reporting of rulemaking. through dialogue, public forums, and clinical quality and other measures solicitation of written comments. Below f. Meaningful EHR User under the Medicare EHR incentive we describe the work of the National program and other Medicare programs. Section 1848(o)(1)(A)(i) of the Act, as Committee on Vital and Health If we were to allow EPs and hospitals to added by section 4101(a) of the HITECH Statistics (NCVHS), the HIT Standards report these measures to CMS prior to Act, limits incentive payments in the Committee and the HIT Policy the beginning of the FY, this reporting Medicare FFS EHR incentive program to Committee, as well as the public input may be of questionable value to other an EP who is a ‘‘meaningful EHR user.’’ we have received on defining Medicare programs requiring reporting Section 1886(n)(1) of the Act, as added meaningful use. of the same measures. For example, if by section 4102(a) of the HITECH Act, The NCVHS is the Department of and when the demonstration of limits incentive payments in the Health and Human Services’ statutory meaningful use includes the submission Medicare FFS EHR incentive program to public advisory body on health data, of quality measures this submission hospitals described in section 1886(d) of statistics, and national health could include measures currently in the the Act. Section 1814(l) of the Act limits information policy. NCVHS derives its RHQDAPU program. As discussed in incentive payments in the Medicare FFS authority from 42 U.S.C. 242k, section section II.A.3. of this proposed rule, we EHR incentive program to CAHs who 306(k) of the Public Health Service Act, do not desire to have a hospital report are ‘‘meaningful EHR users.’’ Section which governs it along with the the same measure twice for two 1903(t)(6)(C)(i)(II) of the Act, as added provisions of Public Law 92–463 different programs. However, if a by section 4201(a)(2) of the HITECH (5 U.S.C. App.2). The full charter and hospital reports these measures from Act, limits incentive payments for membership of the NCVHS is available July through September 2010 for payment years other than the first electronically at http:// payment year 2011 for Medicare and/or payment year to a Medicaid provider www.ncvhs.hhs.gov/. The NCVHS held a public hearing on April 28 and 29, Medicaid EHR incentive program, they who ‘‘demonstrates meaningful use of 2009 to learn from a broad spectrum of would not be relevant for FY 2011 certified EHR technology.’’ We propose stakeholders their views of ‘‘meaningful under the RHQDAPU. Due to the to define at § 495.4 the term ‘‘meaningful use.’’ The NCVHS hearing brought operational challenges presented and EHR user’’ as an EP or eligible hospital together key healthcare and information the statutory requirement to avoid who, for an EHR reporting period for a technology stakeholder groups duplication of payments to the extent payment year, demonstrates meaningful including: Representatives of patients, possible, we are proposing that the use of certified EHR technology in the and more broadly consumers; providers; earliest start date for EHR reporting form and manner consistent with our the public health community; public period be the first day of the payment standards (discussed below). These standards would include use of certified and private payers; vendors; and year. The second consideration for certifying entities. The hearing agenda EHR technology in a manner that is when the EHR reporting period should and testimony supplied is available approved by us. begin is whether to designate specific electronically at http:// start dates. As we are not aware of any 2. Definition of Meaningful Use www.ncvhs.hhs.gov/090428ag.htm. A compelling reason to limit the start a. Background report on the hearing was delivered May dates available to EPs or eligible 15, 2009 to the ONC. The report is hospitals within the payment year, we As discussed previously, an EP or available electronically at http:// propose to allow EPs or eligible eligible hospital must be a meaningful www.ncvhs.hhs.gov/090518rpt.pdf. hospitals to begin their EHR reporting EHR user in order to receive the Written comments from interested period on any date starting with the first incentive payments available under the stakeholders submitted timely to the day of the payment year and ending EHR incentive programs, except in the NCVHS were also considered by the with the latest day in the payment year first payment year for certain Medicaid NCVHS Executive Sub-Committee in the that allows for the EHR reporting period EPs or eligible hospitals. This section drafting of the report. Subsequently, the to be completed by the last day of the (II.A.2.) of this proposed rule discusses National Coordinator for HIT requested payment year. We believe that giving the definition of meaningful use. NCVHS to reflect on the testimony by EPs and eligible hospitals flexibility as Section II.A.3. of this proposed rule, supplying observations. Those to the start date of the EHR reporting is discusses the manner for demonstrating observations are available electronically important, as unforeseen circumstances, meaningful use. In Sections at http://www.ncvhs.hhs.gov/ such as delays in implementation, 1848(o)(2)(A) and 1886(n)(3) of the Act, 090428rpt.pdf. higher than expected training needs and the Congress specified three types of In addition to the work completed by other unexpected hindrances, may requirements for meaningful use: (1) the NCVHS, the HIT Policy Committee, cause an EP or eligible hospital to Use of certified EHR technology in a a Federal Advisory Committee to the potentially miss a target start date. We meaningful manner (for example, Department of Health and Human invite comments on the proposed start electronic prescribing); (2) that the Services (HHS) created by the HITECH dates for the EHR reporting period. certified EHR technology is connected Act, also worked to inform the We acknowledge that all three of in a manner that provides for the definition of meaningful use. The full these aspects will be affected by the electronic exchange of health charter and membership of the HIT need to determine which physicians, information to improve the quality of Policy Committee can be found at

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http://healthit.hhs.gov. The HIT Policy documentation that these types of 1903(t)(6)(C)(i)(II) of the Act, as added Committee formed a Meaningful Use providers have below average adoption by section 4201(a)(2) of HITECH, workgroup. On June 16, 2009, the HIT rates of HIT, we solicited comments prohibits receipt of an incentive Policy Committee heard and discussed directly from these communities. payment, unless ‘‘the Medicaid provider the recommendations from their Section V. of this proposed rule demonstrates meaningful use of Meaningful Use workgroup, and discusses the current adoption rates of certified EHR technology through a subsequently submitted its own HIT. Over 200 representatives from means that is approved by the State and recommendations on meaningful use to these target audiences participated on acceptable to the Secretary, and that the National Coordinator for Health IT. the calls. The vast majority of callers may be based upon the methodologies These recommendations are available were rural providers, although applied under section 1848(o) or electronically at http://healthit.hhs.gov. representatives from vendor 1886(n).’’ (Sections 1848(o) and 1886(n) At the conclusion of the June 16 organizations or provider associations of the Act refer to the Medicare meeting, ONC announced a public also participated. One session was held incentive programs for EPs and eligible comment period to solicit stakeholder to specifically hear from national hospitals respectively.) Under section input on the recommendations and organizations representing rural 1903(t)(8) of the Act to the maximum published a notice in the Federal communities and providers. Summaries extent practicable, we are directed to Register (74 FR 28937). The public of these listening sessions are available avoid duplicative requirements from comment period lasted through June 26, at http://healthit.hhs.gov/ Federal and State governments to 2009. Over 700 public comments were meaningfuluse. Both CMS and the ONC demonstrate meaningful use of certified received by the ONC. A summary, as have reviewed input from these and EHR technology. Provisions included at well as the text of the comments, is additional sources to help inform the section 1848(o)(1)(D)(iii) of the Act also available electronically at http:// definition of meaningful use. contain a Congressional mandate to healthit.hhs.gov. The Meaningful Use b. Common Definition of Meaningful avoid duplicative requirements for workgroup presented its revised Use Under Medicare and Medicaid meaningful use, to the extent recommendations to the full committee practicable. Finally section 1903(t)(8) of based on comments by the full HIT Under sections 1848(o)(1)(A)(i) and the Act allows the Secretary to deem Policy Committee and by the public at 1886(n)(1) of the Act, as added by satisfaction of the requirements for the July 16, 2009 meeting. In developing sections 4101(a) and 4102(a) of the meaningful use of certified EHR its recommendations, the HIT Policy HITECH Act, respectively, an EP or technology for a payment year under eligible hospital must be a meaningful Committee considered a report entitled Medicare to qualify as meaningful use EHR user for the relevant EHR reporting ‘‘National Priorities and Goals’’ (http:// under Medicaid. www.nationalprioritiespartnership.org/ period in order to qualify for the We believe that given the strong level uploadedFiles/NPP/08-253- incentive payment for a payment year. of interaction on meaningful use NQF%20ReportLo%5b6%5d.pdf) Sections 1848(o)(2)(A) and encouraged by the HITECH Act, there generated by the National Priorities 1886(n)(3)(A) of the Act provide that an would need to be a compelling reason Partnership, convened by the National EP and an eligible hospital shall be Quality Forum (NQF). Of the national considered a meaningful EHR user for to create separate definitions for health care priorities set forward by the an EHR reporting period for a payment Medicare and Medicaid. We have found NQF report, the HIT Policy Committee year if they meet the following three no such reasons for disparate definitions chose as priority areas patient requirements: (1) Demonstrates use of in our internal or external discussions. engagement; reduction of racial certified EHR technology in a To the contrary, stakeholders have disparities; improved safety; increased meaningful manner; (2) demonstrates to expressed strong preferences to link the efficiency; coordination of care; and the satisfaction of the Secretary that Medicare and Medicaid EHR incentive improved population health to drive certified EHR technology is connected programs wherever possible. Hospitals their recommendations. Those in a manner that provides for the are entitled to participate in both recommendations are available electronic exchange of health programs, and we are proposing to offer electronically at http://healthit.hhs.gov. information to improve the quality of EPs an opportunity to switch between The HIT Standards Committee, health care such as promoting care the Medicare and Medicaid EHR another Federal Advisory Committee coordination, in accordance with all incentive programs. Therefore, we created by the HITECH Act, provided laws and standards applicable to the propose to create a common definition recommendations related to meaningful exchange of information; and (3) using of meaningful use that would serve as use to ONC. The HIT Standards its certified EHR technology, submits to the definition for providers participating Committee work focuses primarily on the Secretary, in a form and manner in the Medicare FFS and MA EHR the standards surrounding certified EHR specified by the Secretary, information incentive program, and the minimum technology. Further information on the on clinical quality measures and other standard for EPs and eligible hospitals HIT Standards Committee role and measures specified by the Secretary. participating in the Medicaid EHR recommendations can be found in a The HITECH Act requires that to receive incentive program. We clarify that future rulemaking document to be a Medicaid incentive payment in the under Medicaid this common definition provided by ONC for certification of initial year of payment, an EP or eligible would be the minimum standard. While EHR technology (HHS–0151–IFC) and at hospital may demonstrate that they have we would allow States to add additional http://healthit.hhs.gov. engaged in efforts to ‘‘adopt, implement, objectives to the definition of Finally, from June 22 to June 26, 2009, or upgrade certified EHR technology.’’ meaningful use or modify how the the ONC and CMS hosted 21 Details, including special timeframes, existing objectives are measured, the teleconference listening sessions with on how we define and implement Secretary would not accept any State rural providers, small practices, small ‘‘adopt, implement, and upgrade’’ are proposed alternative that does not hospitals, CAHs, and urban safety net proposed in section II.D.7.b.2 of this further promote the use of EHRs and providers to hear their perspectives and proposed rule. For subsequent payment healthcare quality or that would require obtain their input on the definition of years, or the first payment year if an EP additional functionality beyond that of meaningful use. Because of the or eligible hospital chooses, section certified EHR technology. See section

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II.D.7.b.2.of this proposed rule for time recognizing the short time-frame • Stage 2: Our goals for the Stage 2 further details on how a State may available under the HITECH Act for meaningful use criteria, consistent with propose an alternative. providers to begin using certified EHR other provisions of Medicare and For hospitals, we propose to exercise technology. Medicaid law, expand upon the Stage 1 the option granted under section Based on public and stakeholder criteria to encourage the use of health IT 1903(t)(8) of the Act and deem any input, we consider a phased approach to for continuous quality improvement at Medicare provider who is a meaningful be most appropriate. Such a phased the point of care and the exchange of EHR user under the Medicare EHR approach encompasses reasonable information in the most structured incentive program and is otherwise criteria for meaningful use based on format possible, such as the electronic eligible for the Medicaid incentive currently available technology transmission of orders entered using payment to be classified as a meaningful capabilities and provider practice computerized provider order entry EHR user under the Medicaid EHR experience, and builds up to a more (CPOE) and the electronic transmission incentive program. This is applicable robust definition of meaningful use, of diagnostic test results (such as blood only to eligible hospitals, as EPs cannot based on anticipated technology and tests, microbiology, urinalysis, receive an incentive payment under capabilities development. The HITECH pathology tests, radiology, cardiac both Medicare and Medicaid. Act acknowledges the need for this imaging, nuclear medicine tests, We solicit comments as to whether balance by granting the Secretary the pulmonary function tests and other such there exist compelling reasons to give discretion to require more stringent data needed to diagnose and treat the states additional flexibility in measures of meaningful use over time. disease). Additionally we may consider creating disparate definitions beyond Ultimately, consistent with other applying the criteria more broadly to what is proposed. Also if commenting provisions of law, meaningful use of both the inpatient and outpatient in favor of such disparate definitions, hospital settings. certified EHR technology should result • we ask that interested parties also in health care that is patient-centered, Stage 3: Our goals for the Stage 3 comment on whether the proposal of evidence-based, prevention-oriented, meaningful use criteria are, consistent deeming meeting Medicare as sufficient efficient, and equitable. with other provisions of Medicare and for meeting those of Medicaid remains Medicaid law, to focus on promoting Under this phased approach to appropriate under the disparate improvements in quality, safety and meaningful use, we intend to update the definitions. This is applicable only to efficiency, focusing on decision support criteria of meaningful use through hospitals eligible for both the Medicare for national high priority conditions, future rulemaking. We refer to the initial and Medicaid incentive programs. patient access to self management tools, meaningful use criteria as ‘‘Stage 1.’’ We Furthermore, if a State has CMS- access to comprehensive patient data currently anticipate two additional approved additional meaningful use and improving population health. requirements, hospitals deemed as updates, which we refer to as Stage 2 We will continue to evaluate the meaningful users by Medicare would and Stage 3, respectively. We are progression of the meaningful use not have to meet the State-specific considering updating the meaningful definition for consistency with additional meaningful use requirements use criteria on a biennial basis, with the legislative instructions and new in order to qualify for the Medicaid Stage 2 criteria proposed by the end of statutory requirements relating to incentive payment. 2011 and the Stage 3 definition quality measurement and administrative proposed by the end of 2013. The stages simplification. We are aware that the c. Considerations in Defining represent a graduated approach to appropriate approach raises complex Meaningful Use arriving at the ultimate goal. Thus, our questions and we solicit comments on In sections 1848(o)(2)(A) and goals for ‘‘Stage 3’’ meaningful use the proposed approach and alternative 1886(n)(3)(A) of the Act, as added by criteria represent overarching goals possibilities. A different approach sections 4101(a) and 4102(a) of the which, we believe, are attainable by the might, for example, move aspects of HITECH Act, the Congress identifies the end of the EHR incentive programs. We Stage 2 into Stage 3 or vice versa. We broad goal to be accomplished through will continue to evaluate the seek comments on how best to balance the definition of meaningful use of progression of the meaningful use the relevant goals, including promoting certified EHR technology for expanding definition for consistency with adoption of EHRs, avoiding excessive or the use of EHRs. Certified EHR legislative intent and new statutory unnecessary burdens, and improving technology used in a meaningful way by requirements relating to quality health care. providers is one piece of a broader HIT measurement. We solicit comments on As the purpose of these incentives is infrastructure needed to reform the this proposed pathway of meaningful to encourage the adoption and health care system and improve health use. meaningful use of certified EHR care quality, efficiency, and patient • Stage 1: The Stage 1 meaningful use technology, we believe it is desirable to safety. Our goal is for this ultimate criteria focuses on electronically account for whether an EP or eligible vision to drive the definition of capturing health information in a coded hospital is in their first, second, third, meaningful use consistent with format; using that information to track fourth, fifth, or sixth payment year applicable provisions of Medicare and key clinical conditions and when deciding which definition of Medicaid law. communicating that information for care meaningful use to apply in the In defining meaningful use through coordination purposes (whether that beginning years of the program. The HIT the creation of criteria, we have information is structured or Policy Committee in its public meeting balanced competing considerations of unstructured, but in structured format on July 16, 2009 also voiced its approval proposing a definition that best ensures whenever feasible); consistent with of this approach. However, we do not reform of health care and improved other provisions of Medicare and wish to create an additional burden on healthcare quality, encourages Medicaid law, implementing clinical EPs or eligible hospitals for becoming a widespread EHR adoption, promotes decision support tools to facilitate meaningful EHR user before 2015 by innovation, and avoids imposing disease and medication management; creating a higher standard for them excessive or unnecessary burdens on and reporting clinical quality measures relative to an EP or eligible hospital who healthcare providers, while at the same and public health information. first becomes a meaningful EHR user in

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2015. The following paragraphs describe We anticipate updating the criteria of use to receive the incentive payments. our intended alignment in the beginning meaningful use to Stage 3 in time for the For their fourth, fifth, and sixth years that brings all EPs and eligible 2015 payment year and therefore payment year (2016, 2017 and 2018), if hospitals to the same level of anticipate for their fifth payment year applicable, an EP or eligible hospital meaningful use by 2015. As we are only (2015), if applicable, an EP or eligible whose first payment year is 2013 would proposing criteria for Stage 1 of hospital whose first payment year is have to satisfy the Stage 3 criteria of meaningful use in this notice of 2011 would have to satisfy the Stage 3 meaningful use or a subsequent update proposed rulemaking, Stage 1 will be criteria of meaningful use to receive the to the criteria if one is established the criteria for meaningful use for all incentive payments. For their sixth through rulemaking to receive the payment years until updated by future payment year (2016), if applicable, an incentive payments. rulemaking. Medicaid EHR incentive EP or eligible hospital whose first We propose that EPs and eligible program EPs and eligible hospitals have payment year is 2011 would have to hospitals whose first payment year is the option to earn their incentive for satisfy the Stage 3 criteria of meaningful 2014 must satisfy the Stage 1 criteria of their first payment year through the use or a subsequent update to the meaningful use in their first payment adoption, implementation or upgrade of criteria if one is established through year (2014) to receive the incentive certified EHR technology. Those EPs rulemaking to receive the incentive payments. We anticipate updating the and eligible hospitals doing so will not payments. criteria of meaningful use to Stage 3 in have to demonstrate meaningful use in We propose that EPs and eligible time for the 2015 payment year and their first payment year. We intend for hospitals whose first payment year is therefore anticipate for their second their progression to be the same as those 2012 must satisfy the Stage 1 criteria of payment year (2015), if applicable, an who demonstrate meaningful use in meaningful use in their first and second EP or eligible hospital whose first their first payment year. In other words, payment years (2012 and 2013) to payment year is 2014 would have to the second payment year is the second receive the incentive payments. We satisfy the Stage 3 criteria of meaningful payment year regardless of how the anticipate updating the criteria of use to receive the incentive payments. incentive was earned in the first meaningful use to Stage 2 in time for the For their third, fourth, fifth and sixth payment year. 2013 payment year and anticipate for payment year (2016, 2017, 2018, and We intend that Medicaid EPs and their third payment year (2014), an EP 2019), if applicable, an EP or eligible eligible hospitals who qualify for an or eligible hospital whose first payment hospital whose first payment year is incentive payment for adopting, year is 2012 would have to satisfy the 2014 would have to satisfy the Stage 3 implementing, or upgrading in their first Stage 2 criteria of meaningful use to criteria of meaningful use or a payment year would follow the same receive the incentive payments. We subsequent update to the criteria if one meaningful use progression outlined anticipate updating the criteria of is established through rulemaking to below as if their second payment year meaningful use to Stage 3 in time for the receive the incentive payments. was their first payment year. For 2015 payment year and therefore We anticipate updating the criteria of instance a Medicaid EP who received an anticipate for their fourth payment year meaningful use to Stage 3 in time for the incentive for his or her first payment (2015), if applicable, an EP or eligible 2015 payment year and therefore year in 2010 for adopting, hospital whose first payment year is anticipate for all their payment years, an implementing, or upgrading would 2012 would have to satisfy the Stage 3 EP or eligible hospital whose first follow the same guidance starting in criteria of meaningful use to receive the payment year is 2015 would have to their second payment year (2011) as a incentive payments. For their fifth and satisfy the Stage 3 criteria of meaningful Medicare EP who received an incentive sixth payment years (2016 and 2017), if use for 2015. For all subsequent for their first payment year in 2011 for applicable, an EP or eligible hospital payment years, if applicable, an EP or meaningful use of certified EHR whose first payment year is 2012 would eligible hospital whose first payment technology. Another example would be have to satisfy the Stage 3 criteria of year is 2015 would have to satisfy the a Medicaid eligible hospital that meaningful use or a subsequent update Stage 3 criteria of meaningful use or a received an incentive for its first to the criteria if one is established subsequent update to the criteria if one payment year in 2012 for adopting, through rulemaking to receive the is established through rulemaking to implementing, and upgrading would incentive payments. receive the incentive payments. follow the same guidance starting in We propose that EPs and eligible In addition to the equitable concerns their second payment year (2013) as a hospitals whose first payment year is discussed earlier in the transition from Medicare eligible hospital who received 2013 must satisfy the Stage 1 criteria of incentive payments to payment an incentive for their first payment year meaningful use in their first payment adjustments, the primary reasoning for in 2013 for meaningful use of certified year (2013) to receive the incentive developing different stages of EHR technology. payments. We anticipate updating the meaningful use is the current lack of We propose that EPs and eligible criteria of meaningful use to Stage 2 in HIT infrastructure and penetration of hospitals whose first payment year is time for the 2013 payment year and qualified EHRs necessary to support the 2011 must satisfy the requirements of therefore anticipate for their second ambitious goals of the Stage 3 criteria of the Stage 1 criteria of meaningful use in payment year (2014), an EP or eligible meaningful use. Given the anticipated their first and second payment years hospital whose first payment year is maturity of HIT infrastructure inherent (2011 and 2012) to receive the incentive 2013 would have to satisfy the Stage 2 in the strengthening criteria and the payments. We anticipate updating the criteria of meaningful use to receive the increased adoption of certified EHR criteria of meaningful use to Stage 2 in incentive payments. We anticipate technology predicted in section V. of time for the 2013 payment year and updating the criteria of meaningful use this proposed rule, these barriers to therefore anticipate for their third and to Stage 3 in time for the 2015 payment meeting the Stage 3 criteria of fourth payment years (2013 and 2014), year and therefore anticipate for their meaningful use will be removed. an EP or eligible hospital whose first third payment year (2015), if applicable, Table 1 outlines our proposal to apply payment year is 2011 would have to an EP or eligible hospital whose first the respective criteria of meaningful use satisfy the Stage 2 criteria of meaningful payment year is 2013 would have to for each payment year (1st, 2nd, 3rd, use to receive the incentive payments. satisfy the Stage 3 criteria of meaningful etc.) for EPs and eligible hospitals that

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become meaningful EHR users before changes to meaningful use beyond Stage 2015. Please note that nothing in this 3 through future rulemaking. discussion limits us to proposed

TABLE 1—STAGE OF MEANINGFUL USE CRITERIA BY PAYMENT YEAR

Payment year First payment year 2011 2012 2013 2014 2015 +**

2011 ...... Stage 1 .... Stage 1 .... Stage 2 .... Stage 2 .... Stage 3. 2012 ...... Stage 1 .... Stage 1 .... Stage 2 .... Stage 3. 2013 ...... Stage 1 .... Stage 2 .... Stage 3. 2014 ...... Stage 1 .... Stage 3. 2015+ * ...... Stage 3. * Avoids payment adjustments only for EPs in the Medicare EHR Incentive Program. ** Stage 3 criteria of meaningful use or a subsequent update to the criteria if one is established through rulemaking.

Please note that the number of providers may have difficulty meeting (1) Objectives payment years available and the last one or more of the proposed objectives. The first health outcomes policy payment year that can be the first We solicit comments on whether this priority specified by the HIT Policy payment year for an EP or eligible may be the case, and invite commenters Committee is improving quality, safety, hospital varies between the EHR to identify the objectives and associated efficiency and reducing health incentive programs. The applicable measures that may prove out of reach disparities. The HIT Policy Committee payment years for each program are for certain provider types or specialties, identified the following care goals to discussed in section II.B. of this and to suggest specific objective criteria address this priority: proposed rule for the Medicare FFS EHR we could use to determine whether an • Provide access to comprehensive incentive program, in section II.D. for objective and associated measure is patient health data for patient’s the MA EHR incentive program, and in appropriate for different provider types healthcare team. section II.E. for the Medicaid EHR or specialists. • Use evidence-based order sets and incentive program. computerized provider order entry The stages of criteria of meaningful In discussing the objectives that constitute the stage 1 criteria of (CPOE). use and how they are demonstrated are • Apply clinical decision support at described further in this proposed rule meaningful use, we adopted a structure derived from recommendations of the the point of care. and will be updated in subsequent • Generate lists of patients who need proposed rules to reflect advances in HIT Policy Committee of grouping the objectives under care goals, which are in care and use them to reach out to those HIT products and infrastructure. This patients. turn grouped under health outcomes could include updates to the Stage 1 • Report information for quality policy priorities. We believe this criteria in future rulemaking. improvement and public reporting. We invite comments on our alignment structural grouping provides context to between payment year and the criteria the individual objectives; however, the With respect to this last care goal, the of meaningful use particularly in regard grouping is not itself an aspect of HIT Policy Committee proposed a goal ‘‘ to the need to create alignment across meaningful use. The criteria for of Report to patient registries for quality improvement, public reporting, all EPs and eligible hospitals in all EHR meaningful use are based on the etc.’’ We propose to modify this care incentive programs in 2015. objectives and their associated goal because we believe that patient measures. CMS and ONC have carefully d. Stage 1 Criteria for Meaningful Use registries are too narrow a reporting reviewed the objectives and measures To qualify as a meaningful EHR user requirement to accomplish the goals of proposed by the HIT Policy Committee. for 2011, we propose that an EP or quality improvement and public We found many objectives to be well eligible hospital must demonstrate that reporting. We note that the HIT Policy suited to meaningful use, while others they meet all of the objectives and their Committee’s recommended objectives associated measures as set forth in we found to require modification or include the reporting of quality § 495.6. Except as otherwise indicated, clarification. In our discussion we will measures to CMS. We do not believe each objective must be satisfied by an focus on those areas where our proposal that CMS would normally be considered individual EP as determined by unique is a modification of the recommendation a ‘‘patient registry.’’ We also removed National Provider Identifiers (NPIs) and of the HIT Policy Committee. For those the phrase ‘‘etc.’’ We believe that the an individual hospital as determined by areas where we elected not to propose level of ambiguity created by ‘‘etc.’’ is unique CMS certification numbers a modification to the recommendation not appropriate for Federal regulations. (CCN). Below we describe each of the HIT Policy Committee, we note For EPs, we propose the following objective and its associated measures in that there already has been extensive objectives in the Stage 1 criteria of detail. While we welcome comments on public debate and explanation of these meaningful use to further the care goal all aspects of the Stage 1 criteria of recommendations, which can be of improving quality, safety, efficiency meaningful use, we specifically accessed at http://healthit.hhs.gov/ and reducing health disparities. encourage comments on the following meaningfuluse. Even if we do not • Use CPOE. We believe that the term considerations. propose to modify a specific ‘‘CPOE’’ requires additional clarification. While we believe that requiring recommendation of the HIT Policy We propose to define CPOE as entailing satisfaction of all objectives is Committee, we nevertheless welcome the provider’s use of computer appropriate for the majority of comment on whether to do so in the assistance to directly enter medical providers, we are concerned that certain final rule. orders (for example, medications,

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consultations with other providers, status, whether a chronic condition is Medicaid incentive payment, the laboratory services, imaging studies, and present, to patients scheduled for States). The HIT Policy Committee did other auxiliary services) from a certain types of procedures or a host of not include ‘‘or the States’’ in its computer or mobile device. The order is other factors. Similarly, many EPs recommended objective. We propose to also documented or captured in a would not record this information under add the option to report directly to the digital, structured, and computable current standards of practice. Dentists, States for EPs participating in the format for use in improving safety and pediatricians, optometrists, Medicaid EHR incentive program. organization. For Stage 1 criteria, we chiropractors, dermatologists, and Additional discussion of this objective propose that it will not include the radiologists are just a few examples of can be found in section II.A.3 of this electronic transmittal of that order to the EPs who would only in rare proposed rule. pharmacy, laboratory, or diagnostic circumstances require information about • Send reminders to patients per imaging center. We encourage a patient’s advance directive. For these patient preference for preventive/ comments on whether additional reasons, we do not propose to include follow-up care. Patient preference refers specificity is required on the types of ‘‘Record advance directives’’ as an to the patient’s choice of delivery orders encompassed within CPOE. objective of the Stage 1 criteria of method between internet based delivery • Implement drug-drug, drug-allergy, meaningful use for EPs. or delivery not requiring internet access. drug-formulary checks. • Record and chart changes in the • Implement five clinical decision • Maintain an up-to-date problem list following vital signs: Height, weight and support rules relevant to specialty or of current and active diagnoses based on blood pressure and calculate and high clinical priority, including for ® ICD–9–CM or SNOMED CT . display body mass index (BMI) for ages diagnostic test ordering, along with the We believe the term ‘‘problem list’’ 2 and over; plot and display growth ability to track compliance with those requires additional clarification. We charts for children 2–20 years, including rules. describe a ‘‘problem list’’ as a list of BMI. This is a modification to the HIT current and active diagnoses as well as This is a modification to the HIT Policy Policy Committee recommendation to past diagnoses relevant to the current Committee recommendation to require require EPs to implement one clinical care of the patient. eligible professionals to record vital decision support rule relevant to • Generate and transmit permissible signs: Height, weight, blood pressure specialty or high clinical priority. We prescriptions electronically (eRx). and calculate BMI. We added ‘‘plot and made this change to align with and The concept of only permissible display growth charts for children 2–20 support eligible professionals in prescriptions refers to the current years, including BMI’’ to the objective reporting their clinical quality measures restrictions established by the recommended by the HIT Policy proposed in section II.A.3. of this Department of Justice on electronic Committee, as BMI itself does not proposed rule. We anticipate that EPs prescribing for controlled substances. provide adequate information for will report on at least five clinical (The restrictions can be found at children. Trends in height, weight, and quality measures. http://www.deadiversion.usdoj.gov/ BMI among children must be We propose to describe clinical schedules/schedules.htm.) interpreted and understood in the decision support as health information • Maintain active medication list. context of expected parameters of technology functionality that builds • Maintain active medication allergy children of the same age and sex to upon the foundation of an EHR to list. determine whether the child is growing provide persons involved in care • Record the following demographics: appropriately. For example, a BMI of 18 processes with general and person- Preferred language, insurance type, is normal for a 12-year-old boy, and a specific information, intelligently gender, race and ethnicity, and date of marker of obesity for a 5-year-old filtered and organized, at appropriate birth. (http://www.cdc.gov/growthcharts/data/ times, to enhance health and health We note that race and ethnicity codes set1clinical/cj411023.pdf). care. should follow current federal standards • Record smoking status for patients • We do not propose to include the published by the Office of Management 13 years old or older. objective ‘‘Document a progress note for and Budget (http:// The HIT Policy Committee each encounter’’. Documentation of www.whitehouse.gov/omb/ recommended the objective of recording progress notes is a medical-legal inforeg_statpolicy/#dr). smoking status for patients. We propose requirement and a component of basic • We do not propose to include the to add ‘‘for patients 13 years old or EHR functionality, and is not directly objective ‘‘Record Advance directives.’’ older,’’ as we do not believe this related to advanced processes of care or The HIT Policy Committee objective is applicable to patients of all improvements in quality, safety, or recommended that EPs ‘‘record advance ages and there is not consensus in the efficiency. directives.’’ It is unclear whether by this health care community as to what the Finally, the HIT Policy Committee terminology they meant that the appropriate cut off age may be. We further recommended the following two contents of the advance directive be encourage comments on whether this objectives related to administrative recorded or merely the fact that a age limit should be lowered or raised. simplification. Consistent with that patient has an advance directive be • Incorporate clinical lab-test results recommendation—and consistent with noted. Depending on the interpretation, into EHR as structured data. Structured any forthcoming statutory requirements this objective could interfere with data are data that have specified data regarding administrative current State law which varies type and response categories within an simplifications—we propose the significantly from State to State in this electronic record or file. following objectives, with slight matter. We also believe that this • Generate lists of patients by specific modification. objective is only relevant to a limited conditions to use for quality • Check insurance eligibility and undefined patient population when improvement, reduction of disparities, electronically from public and private compared to the patient populations to research, and outreach. payers. Deleted ‘‘where possible’’ from which other objectives listed here apply. • Report ambulatory quality measures the HIT Policy Committee The limits could be based on age, health to CMS (or, for EPs seeking the recommendation. The checking for

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eligibility electronically is already a ‘‘record advance directives.’’ It is unclear relevant to eligible hospitals as EPs and HIPAA Standard Exchange. whether by this terminology they meant therefore includes it for both. We invite • Submit claims electronically to that the contents of the advance comments as to why this phrase may public and private payers. directive be recorded or merely the fact not be applicable to eligible hospitals. For eligible hospitals, we propose the that a patient has an advance directive • Report ambulatory quality measures following objectives in the stage 1 be noted. Depending on the to CMS (or, for eligible hospitals seeking criteria of meaningful use to further interpretation, this objective could the Medicaid incentive payment, the these care goals: interfere with current State law which States). The HIT Policy Committee did • Use CPOE for orders (any type) varies significantly from state to state in not include ‘‘or the States’’ in their directly entered by the authorizing this matter. We also believe that this recommended objective. We propose to provider (for example, MD, DO, RN, PA, objective is only relevant to a limited add the option to report directly to the NP). and undefined patient population when States for Medicaid eligible hospitals We believe that the term ‘‘CPOE’’ compared to the patient populations to participating in the Medicaid EHR requires additional clarification. We which other objectives listed here apply. incentive program. Additional propose to define CPOE as entailing the The limits could be based on age, health discussion can be found in section provider’s use of computer assistance to status, whether a chronic condition is II.A.3. of this proposed rule. • directly enter medical orders (for present, to patients scheduled for Implement five clinical decision example, medications, consultations certain types of procedures or a host of support rules relevant to specialty or with other providers, laboratory other factors. For these reasons, we do high clinical priority, including for services, imaging studies, and other not propose to include ‘‘Record advance diagnostic test ordering, along with the auxiliary services) from a computer or directives’’ as an objective of the Stage ability to track compliance with those mobile device. The order is also 1 criteria of meaningful use for eligible rules. documented or captured in a digital, hospitals. This is a modification to the HIT structured, and computable format for • Record the following vital signs: Policy Committee recommendation to use in improving safety and height, weight and blood pressure and require eligible professionals to organization. It does not include the calculate and display body mass index implement one clinical decision support electronic transmittal of that order to the (BMI) for patients 2 and over; plot and rule relevant to specialty or high clinical pharmacy, laboratory, or diagnostic display growth charts for children 2–20 priority. We made this change to align imaging center in 2011 or 2012. CPOE years, including BMI. with and support eligible professionals is the same as defined above for EPs. We We added ‘‘plot and display growth in reporting their clinical quality welcome comment on whether use of charts for children 2–20 years, including measures proposed in section II.A.3. of CPOE varies between hospitals and EPs BMI’’ to the objective recommended by this proposed rule. We anticipate that in ways that should be addressed. the HIT Policy Committee, as BMI itself most EPs will report on at least five • Implement drug-drug, drug-allergy, does not provide adequate information clinical quality measures from section drug-formulary checks. for children. Trends in height, weight, II.A.3 of this proposed rule and eligible • Maintain an up-to-date problem list and BMI among children must be hospitals will all report on at least five. of current and active diagnoses based on interpreted and understood in the We believe greater clarification is ICD–9–CM or SNOMED CT®. context of expected parameters of required around the term clinical decision support. We propose to We believe the term ‘‘problem list’’ children of the same age and sex to describe clinical decision support as requires additional clarification. We determine whether the child is growing health information technology describe a ‘‘problem list’’ as a list of appropriately. For example, a BMI of 18 functionality that builds upon the current and active diagnoses, as well as is normal for a 12-year-old boy, and a foundation of an EHR to provide past diagnoses relevant to the current marker of obesity for a 5-year-old (ref. persons involved in care processes with care of the patient. http://www.cdc.gov/growthcharts/data/ general and person-specific information, • Maintain active medication list. set1clinical/cj41l023.pdf). intelligently filtered and organized, at • Maintain active medication allergy • Record smoking status for patients appropriate times, to enhance health list. 13 years old or older. • and health care. Record the following demographics: We added ‘‘for patients 13 years old or Finally, the HIT Policy Committee preferred language, insurance type, older’’ as this objective is not applicable further recommended the following two gender, race and ethnicity, date of birth, to patients of all ages. The discussion as objectives related to administrative and date and cause of death in the event to why we chose 13 can be found under simplification. Consistent with that of mortality. the EP objective for ‘‘Record smoking recommendation—and consistent with We are interested in public comments status’’. • any forthcoming statutory requirements on how States and hospitals could work Incorporate clinical lab-test results regarding administrative together to facilitate linkage between the into EHR as structured data. Structured simplifications—we propose the EHR and the full birth and death data are data that have specified data following objectives, with slight certificate information that States type and response categories within a modification. currently require hospitals to collect. record or file. • • Check insurance eligibility We note that race and ethnicity codes Generate lists of patients by specific electronically from public and private should follow current federal standards conditions to use for quality payers. Deleted ‘‘where possible’’ from published by the Office of Management improvement, reduction of disparities, the HIT Policy Committee and Budget (http:// and outreach. recommendation. The checking for www.whitehouse.gov/omb/ The HIT Policy Committee did not eligibility electronically is already a inforeg_statpolicy/#dr). recommend the phrase ‘‘to use for HIPAA Standard Exchange. • We do not propose to include the quality improvement, reduction of • Submit claims electronically to objective ‘‘Record Advance directives.’’ disparities, and outreach’’ for eligible public and private payers. The HIT Policy Committee hospitals as they did for EPs. We believe The second health outcomes policy recommended that eligible hospitals this aspect of the objective is just as priority identified by the HIT Policy

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Committee is to engage patients and request.’’ Providing patients with engagement and empowerment. families in their healthcare. The information and education that is Unfortunately, there is currently a following care goal for meaningful use relevant to their condition, actionable, paucity of knowledge resources that are addresses this priority: culturally competent, and of the integrated within EHRs, that are widely • Provide patients and families with appropriate health literacy level is a available, and that meet these criteria, timely access to data, knowledge, and critical component of patient particularly in multiple languages. We tools to make informed decisions and to engagement and empowerment. intend to work with the policy manage their health. We do not propose Unfortunately, there is currently a committee, the National Library of to preempt any existing Federal or State paucity of knowledge resources that are Medicine (provider of Medline Plus), law regarding the disclosure of integrated within EHRs, that are widely and experts in this area to ensure the information to minors, their parents, or available, and that meet these criteria, feasibility of this measure in the future. their guardians in setting the particularly in multiple languages. We The third health outcomes policy requirements for meaningful use. For intend to work with the policy priority identified by the HIT Policy this reason when it comes to committee, the National Library of Committee is to improve care information provided to the family, we Medicine (provider of Medline Plus), coordination. The HIT Policy let existing Federal and State laws and experts in this area to ensure the Committee recommended the following dictate what is appropriate for feasibility of this measure in the future. care goals to address this priority: disclosure to the patient or the family. • Provide clinical summaries for • Exchange meaningful clinical For purposes of all objectives of the patients for each office visit. information among professional health Stage 1 criteria of meaningful use Changed from encounter to office care team. involving the disclosure of information visit. The HIT Policy Committee For EPs and eligible hospitals, we to a patient, a disclosure made to a recommended the objective ‘‘Provide propose the following objectives in the family member or a patient’s guardian clinical summaries for patients for each stage 1 criteria of meaningful use to consistent with Federal and State law encounter.’’ We believe this objective further this care goal: may substitute for a disclosure to the requires further clarification in order to • Capability to exchange key clinical patient. make the distinction that it is not meant information (for example, problem list, For EPs, we propose the following to apply to alternative encounters such medication list, allergies, and diagnostic objectives in the stage 1 criteria of as telephone or Web visits. As a result, test results), among providers of care meaningful use to further this care goal: we propose to revise this objective to and patient authorized entities • Provide patients with an electronic ‘‘Provide clinical summaries for patients electronically. copy of their health information for each office visit.’’ By ‘‘diagnostic test results’’ we mean all (including diagnostics test results, For eligible hospitals, we propose the data needed to diagnose and treat problem list, medication lists, allergies) following objectives in the stage 1 disease, such as blood tests, upon request. criteria of meaningful use to further this microbiology, urinalysis, pathology Consistent with the HIT Policy care goal: tests, radiology, cardiac imaging, Committee’s recommendations, we • Provide patients with an electronic nuclear medicine tests, and pulmonary propose the following additional copy of their health information function tests. Where available in clarification of this objective. Electronic (including diagnostic test results, structured electronic format (for copies may be provided through a problem list, medication lists, allergies, example, drug and clinical lab data), we number of secure electronic methods discharge summary, procedures), upon expect that this information would be (for example, personal health record request. Consistent with the HIT Policy exchanged in electronic format. (PHR), patient portal, CD, USB drive). Committee’s recommendations, we However, where the information is • Provide patients with timely propose the following additional available only in unstructured electronic access to their health clarification of this objective. Electronic electronic formats (for example, free text information (including lab results, copies may be provided through a and scanned images), we would allow problem list, medication lists, allergies) number of secure electronic methods the exchange of unstructured within 96 hours of the information (for example, Personal Health Record information. Patient authorized entities being available to the EP. (PHR), patient portal, CD, USB drive). could include any individual or Also, consistent with the HIT Policy • Provide patients with an electronic organization to which the patient has Committee recommendations, we copy of their discharge instructions and granted access to their clinical propose the following additional procedures at time of discharge, upon information. Examples would include clarification of this objective. Electronic request. an insurance company that covers the access may be provided by a number of Also, consistent with the HIT Policy patient or a personal health record secure electronic methods (for example, Committee recommendations, we vendor identified by the patient. PHR, patient portal, CD, USB drive). propose the following additional • Perform medication reconciliation Timely is defined as within 96 hours of clarification of this objective. Electronic at relevant encounters and each the information being available to the access may be provided by a number of transition of care. EP either through the receipt of final lab secure electronic methods (for example, We believe greater clarification is results or a patient interaction that PHR, patient portal, CD, USB drive). needed around the term ‘‘medication updates the EP’s knowledge of the • We do not propose to include the reconciliation’’. Public input received by patient’s health. We judge 96 hours to objective ‘‘Provide access to patient- the NCVHS Executive Subcommittee be a reasonable amount of time to specific education resources upon and the HIT Policy Committee and our ensure that certified EHR technology is request.’’ Providing patients with prior experiences indicate confusion in up to date. We welcome comment on if information and education that is the healthcare industry as to what a shorter or longer time is advantageous. relevant to their condition, actionable, constitutes medication reconciliation. • We do not propose to include the culturally competent, and of the We propose to describe medication objective ‘‘Provide access to patient- appropriate health literacy level is a reconciliation as the process of specific education resources upon critical component of patient identifying the most accurate list of all

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medications that the patient is taking, submission where possible and use of the certified EHR technology including name, dosage, frequency and accepted. supports compliance with the HIPAA route, by comparing the medical record • Capability to provide electronic Privacy and Security Rules and to an external list of medications syndromic surveillance data to public compliance with fair sharing data obtained from a patient, hospital or health agencies and actual transmission practices outlined in the Nationwide other provider. Also we would clarify according to applicable law and Privacy and Security Framework (http:// transition of care as transfer of a patient practice. healthit.hhs.gov/portal/server.pt/ from one clinical setting (inpatient, For eligible hospitals, we propose the gateway/ outpatient, physician office, home following objectives in the stage 1 PTARGS_0_10731_848088_0_0_18/ health, rehab, long-term care facility, criteria of meaningful use to further this NationwidePS_Framework-5.pdf), but etc.) to another or from one EP or care goal: do not believe meaningful use of eligible hospital (as defined by CCN) to • Capability to submit electronic data certified EHR technology is the another. A relevant encounter would be to immunization registries and actual appropriate regulatory tool to ensure any encounter that the EP or eligible submission where required and such compliance with the HIPAA hospital judges performs a medication accepted. Privacy and Security Rules. reconciliation due to new medication or • Capability to provide electronic (2) Health IT Functionality Measures long gaps in time between patient submission of reportable (as required by encounters or other reasons determined state or local law) lab results to public In order for an EP or an eligible by the EP or eligible hospital. We health agencies and actual submission hospital to demonstrate that it meets encourage comments on whether our where it can be received. these proposed objectives, we believe a descriptions of ‘‘transition of care’’ and • Capability to provide electronic measure is necessary for each objective. ‘‘relevant encounter’’ are sufficiently syndromic surveillance data to public To provide structure to these measures, clear and medically relevant. health agencies and actual transmission we group the measures into two • Provide summary care record for according to applicable law and categories: Health IT functionality each transition of care or referral. practice. measures and clinical quality measures. This objective was not explicitly The fifth health outcomes policy The health IT functionality measures are included in the HIT Policy Committee’s priority is to ensure adequate privacy discussed in this section, while the recommended objectives. However, they and security protections for personal clinical quality measures are discussed did include a measure for the ‘‘percent health information. The following care in section II.A.3 of this proposed rule. Without a measure for each objective, of transitions in care for which goals for meaningful use address this we believe that the definition of summary care record is shared. We priority: meaningful use becomes too ambiguous believe that in order for a measure to be • Ensure privacy and security to fulfill its purpose. The use of relevant it must correspond to an protections for confidential information measures also creates the flexibility to objective in the definition of meaningful through operating policies, procedures, account for realities of current HIT use. Therefore, we propose to add this and technologies and compliance with products and infrastructure and the objective in order to be able to include applicable law. ability to account for future advances. the recommended measure. • Provide transparency of data The HIT Policy Committee did Furthermore, we add referrals because sharing to patient. recommend some measures; however, the sharing of the patient care summary For EPs and eligible hospitals, we they did not explicitly link each from one provider to another propose the following objective in the measure to an objective. Therefore, the communicates important information stage 1 criteria of meaningful use to proposed measures set forth below are that the patient may not have been able further these care goals: a significant departure from the to provide, and can significantly • Protect electronic health recommendation of the HIT Policy improve the quality and safety of information created or maintained by referral care, and reduce unnecessary Committee. the certified EHR technology through For each of these measures utilizing a and redundant testing. the implementation of appropriate The fourth health outcomes policy percentage and the reporting of clinical technical capabilities. priority identified by the HIT Policy quality measures, we propose at Committee is improving population and This objective is different from the two § 495.10 that EPs and eligible hospitals public health. The HIT Policy objectives recommended by the HIT submit numerator and denominator Committee identified the following care Policy Committee. Those objectives information to CMS. We invite comment goal to address this priority: were ‘‘Compliance with HIPAA Privacy on our burden estimates associated with • The patient’s health care team and Security Rules’’ and ‘‘Compliance reporting these measures (see section III. communicates with public health with fair data sharing practices set forth of this proposed rule). agencies. The goal as recommended by in the Nationwide Privacy and Security EP Objective: Use CPOE. the HIT Policy Committee is Framework’’. While we presume that the EP Measure: CPOE is used for at least ‘‘communicate with public health HIT Policy Committee is referring to the 80 percent of all orders. agencies.’’ We found this goal to be certified EHR technology and its use CPOE is a capability included in the somewhat ambiguous, as it does not being in compliance with the HIPAA certification criteria for certified EHR specify who must communicate with Privacy and Security Rules, it is not technology (to be defined by the ONC in public health agencies. We propose to explicit. Compliance with HIPAA its upcoming interim final rule). We specify ‘‘the patient’s health care team’’ privacy and security rules is required believe it is important to ensure that this as who would communicate with public for all covered entities, regardless of capability is continuously utilized. health agencies. whether they participate in the EHR Therefore, we believe in order to meet For EPs, we propose the following incentive programs or not. Furthermore, this objective it is not sufficient to objectives in the stage 1 criteria of compliance constitutes a wide range of demonstrate use of this capability once, meaningful use to further this care goal: activities, procedures, and but rather, an EP must utilize this • Capability to submit electronic data infrastructure. We propose to rephrase capability as part of his or her daily to immunization registries and actual the objective to ensure that meaningful work process.

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We consider two methods of for at each location/practice where they see practice, we would include in our measuring use of the CPOE patients it could become impossible to review both of these locations. functionality: the percentage of orders reach the thresholds set for measuring As this objective relies solely on a entered using CPOE or a count of orders the objectives. We do not seek to capability included as part of certified entered using CPOE. To illustrate the exclude EPs who meaningfully use EHR technology and is not, for purposes difference, an example of measuring certified EHR technology when it is of Stage 1 criteria, reliant on the percentage use of the CPOE available because they also provide care electronic exchange of information, we functionality would be 80 percent of all in another practice where certified EHR believe it would be appropriate to set a of an EP’s orders were entered using the technology is not available. Therefore high percentage threshold. We therefore CPOE functionality of certified EHR we are proposing all measures be propose to set the percentage required technology during the EHR reporting limited to actions taken at practices/ for successful demonstration at 80 period. An example of counting orders locations equipped with certified EHR percent. Though full compliance (that using the CPOE functionality would be technology. A practice is equipped if is, 100 percent) is the ultimate goal, 80 requiring that the EP entered at least 100 certified EHR technology is available at percent seemed an appropriate standard orders using CPOE during the EHR the beginning of the EHR reporting for Stage 1 meaningful use as it creates reporting period. A count of orders period for a given location. Equipped a high standard, while still allowing entered using CPOE would be easier to does not mean the certified EHR room for technical hindrances and other document than a percentage of orders, technology is functioning on any given barriers to reaching full compliance. as an EP would only have to count the day in the EHR reporting period. For other objectives that are reliant on number of times he or she entered an Allowances for downtime and other the electronic exchange of information, order using CPOE, as opposed to technical issues with certified EHR we are cognizant that in most areas of tabulating both when he or she did so technology are made in the the country, the infrastructure necessary and when he or she failed to do so. establishment of the measure to support such exchange is not yet However, a count does not enable thresholds. We are concerned that currently available. We anticipate variations between EPs to be accounted seeing a patient without certified EHR raising the threshold for these objectives for. For instance, a count-based technology available does not advance in future definitions of meaningful use measurement would not take into the health care policy priorities of the as the capabilities of HIT infrastructure consideration differences in patient definition of meaningful use. We are increases. The intent and policy goal volume among EPs, which may be a also concerned about possible with raising this threshold is to ensure concern to those EPs with a low patient inequality between EPs receiving the that meaningful use encourages patient- volume. A percentage-based same incentive, but using certified EHR centric, interoperable health measurement would account for technology for different proportions of information exchange across provider variations in volume and would allow their patient population. We believe that organizations regardless of provider’s for a more revealing measurement of an an EP would have the greatest control of business affiliation or EHR platform. EP’s individual performance in meeting Eligible Hospital Objective: Use of whether certified EHR technology is the objective. Therefore, we are CPOE for orders (any type) directly available in the practice in which they proposing that an EP’s successful entered by authorizing provider (for see the greatest proportion of their completion of this objective be based on example, MD, DO, RN, PA, NP). a percentage. patients. We are proposing that to be a Eligible Hospital Measure: CPOE is To calculate the percentage, CMS and meaningful EHR user an EP must have used for at least 10 percent of all orders. ONC have worked together to define the 50 percent or more of their patient To calculate the percentage, CMS and following: encounters during the EHR reporting ONC have worked together to define the • The numerator. period at a practice/location or following: • The denominator. practices/locations equipped with • The numerator. • The required percentage for certified EHR technology. An EP for • The denominator. demonstrating successful attainment of who does not conduct 50 percent of • The required percentage for an objective. their patient encounters in any one demonstrating successful attainment of The numerator for this objective is practice/location would have to meet an objective. orders issued by the EP entered using the 50 percent threshold through a The numerator for this objective is the CPOE functionality of certified EHR combination of practices/locations. orders entered in an inpatient facility/ technology during the EHR reporting While control is less assured in this department that falls under the eligible period. The denominator for this situation, CMS still needs to advance hospital’s CCN and by an authorized objective is all orders issued by the EP the health care priorities of the provider using CPOE functionality of during the EHR reporting period. These definition of meaningful use and certified EHR technology during the are orders issued by an EP for both their provide some level of equity. We invite EHR reporting period. Inpatient facility/ Medicare/Medicaid population and all comments as to whether this department is defined by the place of other patients. We believe it is unlikely denominator is feasible to obtain for service code 21. Further discussion that an EP would use one record EPs, whether this exclusion (the about POS 21 is available at section keeping system for one patient denominator for patients seen when II.A.6. of this proposed rule and at population and another system for certified EHR technology is not http://www.cms.hhs.gov/ another patient population at one available) is appropriate, whether a PlaceofServiceCodes/. The denominator location. Requiring reporting differences minimum threshold is necessary and for this objective is all orders entered in based on payers would actually increase whether 50 percent is an appropriate an inpatient facility/department that the burden of meeting meaningful use. threshold. We note that in evaluating falls under the eligible hospital’s CCN We are concerned about the application the 50 percent threshold, our proposal and issued by the authorized providers of this denominator for EPs who see is to review all locations/organizations in the hospital during the EHR reporting patients in multiple practices or at which an EP practices. So, for period. These are orders are those multiple locations. If an EP does not example, if the EP practices at both an issued are for both their Medicare/ have certified EHR technology available FQHC and within his or her individual Medicaid population and all other

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patients. The rationale for the demonstrate this capability once, but this objective it is not sufficient to establishment of this measure is rather to comply with the objective, an demonstrate this capability once, but identical to that of the EP, except in the EP or an eligible hospital must utilize rather to comply with the objective, an establishment of the threshold this capability as part of the daily work EP must utilize this capability as part of percentage. In considering CPOE, the process. the daily work process. HIT Policy Committee did specify this As discussed under CPOE, we will As discussed under CPOE, we will lower percentage (10 percent) for use a percentage. To calculate the use a percentage. To calculate the eligible hospitals. Public input percentage, CMS and ONC have worked percentage, CMS and ONC have worked described previously in this proposed together to define the following for this together to define the following for this rule indicated that CPOE is traditionally objective: objective: one of the last capabilities implemented • The numerator. • The numerator. at hospitals. Also, many hospitals • The denominator. • The denominator. • choose to implement one department at The required percentage for • The required percentage for a time. Detailed comments can be found demonstrating successful attainment of demonstrating successful attainment of at http://healthit.hhs.gov/ an objective. an objective. meaningfuluse. For these reasons the The numerator for this objective is the The numerator for this objective is the HIT Policy Committee recommended number of unique patients seen by an number of prescriptions for other than this lower threshold. We agree with the EP or admitted to an inpatient facility/ controlled substances generated and lower threshold for the same reasons. department (POS 21) that falls under the transmitted electronically during the EP/Eligible Hospital Objective: eligible hospital’s CCN during the EHR EHR reporting period. The denominator reporting period that have at least one for this objective is the number of Implement drug-drug, drug-allergy, ® drug-formulary checks. ICD–9–CM or SNOMED CT -coded prescriptions written for other than EP/Eligible Hospital Measure: The EP/ entry or an indication of none in the controlled substances during the EHR eligible hospital has enabled this problem list. A unique patient means reporting period. While this measure functionality. that even if a patient is seen multiple does rely on the electronic exchange of The capability of conducting times during the EHR reporting period information based on the public input automated drug-drug, drug-allergy, and they are only counted once. The reason previously discussed and our own drug-formulary checks is included in we propose to base the measure on experiences with e-Rx programs, we the certification criteria for certified unique patients as opposed to every believe this is the most robust electronic EHR technology (to be determined by patient encounter, is that a problem list exchange currently occurring and ONC in its upcoming interim final rule). would not necessarily have to be propose 75 percent as an achievable This automated check provides updated at every visit. The denominator threshold for the Stage 1 criteria of information to advise the EP or eligible for this objective is the number of meaningful use. Though full compliance hospital’s decisions in prescribing drugs unique patients seen by the EP or (that is, 100 percent) is the ultimate to a patient. The only action taken by admitted to an inpatient facility/ goal, 75 percent seemed an appropriate the EP or eligible hospital is to consider department (POS 21) that falls under the standard for Stage 1 meaningful use as this information. Many current EHR eligible hospital’s CCN during the EHR it creates a high standard, while still technologies have the option to disable reporting period. As this objective relies allowing room for technical hindrances these checks and the certification solely on a capability included as part and other barriers to reaching full process does not require the removal of of certified EHR technology and is not compliance. this option. Therefore, in order to meet reliant on the electronic exchange of EP/Eligible Hospital Objective: this objective, an EP or eligible hospital information, we propose to set the Maintain active medication list. would be required to enable this percentage required for successful EP/Eligible Hospital Measure: At least functionality. While this does not demonstration at 80 percent. The 80 percent of all unique patients seen by ensure that an EP or an eligible hospital reasoning for this is the same as under the EP or admitted by the eligible is considering the information provided, CPOE for EPs. Though full compliance hospital have at least one entry (or an it does ensure that the information is (that is, 100 percent) is the ultimate indication of ‘‘none’’ if the patient is not available. goal, 80 percent seemed an appropriate currently prescribed any medication) EP/Eligible Hospital Objective: standard for Stage 1 meaningful use as recorded as structured data. Maintain an up-to-date problem list of it creates a high standard, while still The capability to maintain an active current and active diagnoses based on allowing room for technical hindrances medication list is included in the ICD–9–CM or SNOMED CT®. and other barriers to reaching full certification standards for certified EHR EP/Eligible Hospital Measure: At least compliance. technology (to be defined by ONC in its 80 percent of all unique patients seen by EP Objective: Generate and transmit upcoming interim final rule). the EP or admitted to the eligible permissible prescriptions electronically Meaningful use seeks to ensure that hospital have at least one entry or an (eRx). those capabilities are utilized. indication of none recorded as EP Measure: At least 75 percent of all Therefore, we believe in order to meet structured data. permissible prescriptions written by the this objective it is not sufficient to The capability to maintain an up-to- EP are transmitted electronically using demonstrate this capability once, but date problem list of current and active certified EHR technology. rather to comply with the objective, an diagnoses based on ICD–9–CM or The capability to generate and EP or eligible hospital must utilize this ® SNOMED CT is included in the transmit permissible prescriptions capability as part of the daily work certification criteria for certified EHR electronically is included in the process. technology (to be defined by ONC in its certification criteria for certified EHR As discussed under CPOE, we will upcoming interim final rule). technology (to be defined by ONC in its use a percentage. To calculate the Meaningful use seeks to ensure that upcoming interim final rule). percentage, CMS and ONC have worked those capabilities are utilized. Meaningful use seeks to ensure that together to define the following for this Therefore, we believe in order to meet those capabilities are utilized. objective: this objective it is not sufficient to Therefore, we believe in order to meet • The numerator.

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• The denominator. • The required percentage for department (POS 21) that falls under the • The required percentage for demonstrating successful attainment of eligible hospital’s CCN during the EHR demonstrating successful attainment of an objective. reporting period who have all required an objective. The numerator for this objective is the demographic elements (preferred The numerator for this objective is the number of unique patients seen by the language, insurance type, gender, race, number of unique patients seen by the EP or admitted to an inpatient facility/ and ethnicity, date of birth and, for EP or admitted to an inpatient facility/ department (POS 21) that falls under the hospitals, date and cause of death in the department (POS 21) that falls under the eligible hospital’s CCN during the EHR case of mortality) recorded as structured reporting period who have at least one eligible hospital’s CCN during the EHR data in their electronic record. A unique entry (or an indication of ‘‘none’’) reporting period who have at least one patient is discussed under the objective recorded as structured data in their entry (or an indication of ‘‘none’’ if the of maintaining an up-to-date problem medication allergy list. A unique patient patient is not currently prescribed any list. The denominator for this objective is discussed under the objective of medication) recorded as structured data is the number of unique patients seen by maintaining an up-to-date problem list. in their medication list. A unique the EP or admitted to an inpatient The denominator for this objective is the patient is discussed under the objective facility/department (POS 21) that falls number of unique patients seen by the under the eligible hospital’s CCN during of maintaining an up-to-date problem EP or admitted to an inpatient facility/ the EHR reporting period. As this list. The denominator for this objective department (POS 21) that falls under the objective relies solely on a capability is the number of unique patients seen by eligible hospital’s CCN during the EHR included as part of certified EHR the EP or admitted to an inpatient reporting period. As this objective relies technology and is not, for purposes of facility/department (POS 21) that falls solely on a capability included as part Stage 1 criteria, reliant on the electronic under the eligible hospital’s CCN during of certified EHR technology and is not exchange of information, we propose to the EHR reporting period. As this reliant on the electronic exchange of set the percentage required for objective relies solely on a capability information, we propose to set the successful demonstration at 80 percent. included as part of certified EHR percentage required for successful The reasoning for this is the same as technology and is not reliant on the demonstration at 80 percent. The under CPOE for EPs. electronic exchange of information, we reasoning for this is the same as under EP/Eligible Hospital Objective: Record propose to set the percentage required CPOE for EPs. Though full compliance and chart changes in vital signs. for successful demonstration at 80 (that is, 100 percent) is the ultimate EP/Eligible Hospital Measure: For at percent. The reasoning for this is the goal, 80 percent seemed an appropriate least 80 percent of all unique patients same as under CPOE for EPs. Though standard for Stage 1 meaningful use as age 2 and over seen by the EP or full compliance (that is, 100 percent) is it creates a high standard, while still admitted to the eligible hospital, record the ultimate goal, 80 percent seemed an allowing room for technical hindrances blood pressure and BMI; additionally, appropriate standard for Stage 1 and other barriers to reaching full plot growth chart for children age 2 to meaningful use as it creates a high compliance. 20. standard, while still allowing room for EP/Eligible Hospital Objective: Record The capability to record vital signs is technical hindrances and other barriers demographics. included in the certification standards to reaching full compliance. EP/Eligible Hospital Measure: At least for certified EHR technology (to be EP/Eligible Hospital Objective: 80 percent of all unique patients seen by defined by ONC in its upcoming interim Maintain active medication allergy list. the EP or admitted to the eligible final rule). Meaningful use seeks to EP/Eligible Hospital Measure: At least hospital have demographics recorded as ensure that those capabilities are 80 percent of all unique patients seen by structured data. utilized. Therefore, we believe in order the EP or admitted to the eligible The capability to record to meet this objective it is not sufficient hospital have at least one entry (or an demographics as structured data is to demonstrate this capability once, but indication of ‘‘none’’ if the patient has no included in the certification standards rather to comply with the objective, an medication allergies) recorded as for certified EHR technology (to be EP or eligible hospital must utilize this structured data. defined by ONC in its upcoming interim capability as part of the daily work The capability to maintain an active final rule). Meaningful use seeks to process. medication allergy list using structured ensure that those capabilities are As discussed under CPOE, we will data is included in the certification utilized. Therefore, we believe in order use a percentage. To calculate the standards for certified EHR technology to meet this objective it is not sufficient percentage, CMS and ONC have worked (to be defined by ONC in its upcoming to demonstrate this capability once, but together to define the following for this interim final rule). Meaningful use seeks rather to comply with the objective, an objective: EP or eligible hospital must utilize this • The numerator. to ensure that those capabilities are • utilized. Therefore, we believe in order capability as part of the daily work The denominator. • The required percentage for to meet this objective it is not sufficient process. demonstrating successful attainment of to demonstrate this capability once, but As discussed under CPOE, we will use a percentage. To calculate the an objective. rather to comply with the objective, an The numerator for this objective is the EP or eligible hospital must utilize this percentage, CMS and ONC have worked together to define the following for this number of unique patients age 2 and capability as part of the daily work over seen by the EP or admitted to an process. objective: • The numerator. inpatient facility/department (POS 21) As discussed under CPOE, we will • The denominator. that falls under the eligible hospital’s use a percentage. To calculate the • The required percentage for CCN during the EHR reporting period percentage, CMS and ONC have worked demonstrating successful attainment of who have a record of their blood together to define the following for this an objective. pressure, and BMI (growth chart for objective: The numerator for this objective is the children 2–20) in their record. A unique • The numerator. number of unique patients seen by the patient is discussed under the objective • The denominator. EP or admitted to an inpatient facility/ of maintaining an up-to-date problem

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list. The denominator for this objective As this objective relies solely on a under the eligible hospital’s CCN whose is the number of unique patients age 2 capability included as part of certified results are expressed in a positive or or over seen by the EP or admitted to an EHR technology and is not, for purposes negative affirmation or as a number. inpatient facility/department (POS 21) of Stage 1 criteria, reliant on the This objective is reliant on the that falls under the eligible hospital’s electronic exchange of information, we electronic exchange of information. We CCN during the EHR reporting period. propose to set the percentage required are cognizant that in most areas of the As this objective relies solely on a for successful demonstration at 80 country, the infrastructure necessary to capability included as part of certified percent. The reasoning for this is the support such exchange is still being EHR technology and is not, for purposes same as under CPOE by the EP. Though developed. Therefore, we believe that 80 of Stage 1 criteria, reliant on the full compliance (that is, 100 percent) is percent is too high a threshold for the electronic exchange of information, we the ultimate goal, 80 percent seemed an Stage 1 criteria of meaningful use. We propose to set the percentage required appropriate standard for Stage 1 propose 50 percent as the threshold for successful demonstration at 80 meaningful use as it creates a high based on our discussions with EHR percent. The reasoning for this is the standard, while still allowing room for vendors, current EHR users, and same as under CPOE for EPs. Though technical hindrances and other barriers laboratories. We invite comment on full compliance (that is, 100 percent) is to reaching full compliance. whether this 50 percent is feasible for the ultimate goal, 80 percent seemed an EP/Eligible Hospital Objective: the Stage 1 criteria of meaningful use. appropriate standard for Stage 1 Incorporate clinical lab-test results into We anticipate raising the threshold for meaningful use as it creates a high EHR as structured data. this objective in future stages of the standard, while still allowing room for EP/Eligible Hospital Measure: At least criteria of meaningful use as the technical hindrances and other barriers 50 percent of all clinical lab tests results capabilities of HIT infrastructure to reaching full compliance. ordered by the EP or by an authorized increases. EP/Eligible Hospital Objective: Record provider of the eligible hospital during EP/Eligible Hospital Objective: smoking status for patients 13 years old the EHR reporting period whose results Generate lists of patients by specific or older. are in either in a positive/negative or conditions to use for quality EP/Eligible Hospital Measure: At least numerical format are incorporated in improvement, reduction of disparities, 80 percent of all unique patients 13 certified EHR technology as structured research, and outreach. years old or older seen by the EP or data. EP/Eligible Hospital Measure: admitted to the eligible hospital have The capability to incorporate lab-test Generate at least one report listing ‘‘smoking status’’ recorded. results is included in the certification patients of the EP or eligible hospital The capability to record smoking standards for certified EHR technology with a specific condition. status is included in the certification (to be defined by ONC in its upcoming The capability to generate lists of standards for certified EHR technology interim final rule). Meaningful use seeks patients by specific conditions is (to be defined by ONC in its upcoming to ensure that those capabilities are included in the certification criteria for interim final rule). Meaningful use seeks utilized. Therefore, we believe in order certified EHR technology (to be defined to ensure that those capabilities are to meet this objective it is not sufficient by ONC in its upcoming interim final utilized. Therefore, we believe in order to demonstrate this capability once, but rule). Meaningful use seeks to ensure to meet this objective it is not sufficient rather to comply with the objective, an that those capabilities are utilized. to demonstrate this capability once, but EP or eligible hospital must utilize this Therefore, we believe in order to meet rather to comply with the objective, an capability as part of the daily work this objective an EP or eligible hospital EP or eligible hospital must utilize this process. should utilize this capability at least capability as part of the daily work As discussed under CPOE, we will once during the EHR reporting period so process. use a percentage. To calculate the this information would be available to As discussed under CPOE, we will percentage, CMS and ONC have worked them for their use. An EP or eligible use a percentage. To calculate the together to define the following for this hospital is best positioned to determine percentage, CMS and ONC have worked objective: which reports are most useful to their together to define the following for this • The numerator. care efforts. Therefore, we do not objective: • The denominator. propose to direct certain reports be • • The numerator. The required percentage for created, but rather to require EPs and • The denominator. demonstrating successful attainment of hospitals to attest to the ability of the EP • The required percentage for an objective. or eligible hospital to do so and to attest demonstrating successful attainment of The numerator for this objective is the that they have actually done so at least an objective. number of lab tests ordered during the once. The numerator for this objective is the EHR reporting period by the EP or EP Objective: Report ambulatory number of unique patients age 13 or authorized providers of the eligible quality measures to CMS or the States. older seen by the EP or admitted to an hospital for patients admitted to an EP Measure: For 2011, an EP would inpatient facility/department (POS 21) inpatient facility/department (POS 21) provide the aggregate numerator and that falls under the eligible hospital’s that falls under the eligible hospital’s denominator through attestation as CCN during the EHR reporting period CCN whose results are expressed in a discussed in section II.A.3 of this who have a record of their smoking positive or negative affirmation or as a proposed rule. For 2012, an EP would status. A unique patient is discussed number and are incorporated as electronically submit the measures are under the objective of maintaining an structured data into certified EHR discussed in section II.A.3. of this up-to-date problem list. The technology. The denominator for this proposed rule. denominator for this objective is the objective is the number of lab tests Eligible Hospital Objective: Report number of unique patients age 13 or ordered during the EHR reporting hospital quality measures to CMS or the older seen by the EP or admitted to an period by the EP or authorized States. inpatient facility/department (POS 21) providers of the eligible hospital for Eligible Hospital Measure: For 2011, that falls under the eligible hospital’s patients admitted to an inpatient an eligible hospital would provide the CCN during the EHR reporting period. facility/department (POS 21) that falls aggregate numerator and denominator

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through attestation as discussed in patient population by age is the best • The required percentage for section II.A.3 of this proposed rule. For approach. demonstrating successful attainment of 2012, an eligible hospital would EP/Eligible Hospital Objective: an objective. electronically submit the measures are Implement five clinical decision The numerator for this objective is the discussed in section II.A.3. of this support rules relevant to specialty or number of unique patients seen by the proposed rule. high clinical priority, including for EP or admitted to an inpatient facility/ EP Objective: Send reminders to diagnostic test ordering, along with the department (POS 21) that falls under the patients per patient preference for ability to track compliance with those eligible hospital’s CCN during the EHR preventive/follow-up care. rules. reporting period whose insurance EP Measure: Reminder sent to at least EP/Eligible Hospital Measure: eligibility is checked electronically. A 50 percent of all unique patients seen by Implement five clinical decision unique patient is discussed under the the EP or admitted to the eligible support rules relevant to the clinical objective of maintaining an up-to-date hospital that are 50 and over. quality metrics the EP/Eligible Hospital problem list. The denominator for this The capability to generate reminders is responsible for as described further in objective is the number of unique for preventive/follow-up care is section II.A.3. patients seen by the EP or admitted to included in the certification standards The capability to provide clinical an inpatient facility/department (POS for certified EHR technology (to be decision support is included in the 21) that falls under the eligible defined by ONC in its upcoming interim certification standards for certified EHR hospital’s CCN during the EHR final rule). Meaningful use seeks to technology (to be defined by ONC in its reporting period whose insurer allows ensure that those capabilities are upcoming interim final rule). Clinical for the electronic verification of utilized. Therefore, we believe in order decision support at the point of care is eligibility. While this objective does rely to meet this objective it is not sufficient a critical aspect of improving quality, on the electronic exchange of to demonstrate this capability once, but safety, and efficiency. Research has information this particular exchange is rather to comply with the objective an shown that decision support must be an established HIPAA standard EP must utilize this capability as part of targeted and actionable to be effective, transaction, therefore we propose to set ‘‘ ’’ the daily work process. and that alert fatigue must be avoided. the percentage required for successful As discussed under CPOE, we will Establishing decision supports for a demonstration at 80 percent. The use a percentage. To calculate the small set of high priority conditions, additional reasoning for this is the same percentage, CMS and ONC have worked ideally linked to quality measures being as under CPOE for EPs. Though full together to define the following for this reported, is feasible and desirable. compliance (that is, 100 percent) is the objective: Meaningful use seeks to ensure that ultimate goal, 80 percent seemed an those capabilities are utilized. • The numerator. appropriate standard for Stage 1 Therefore, we believe in order to meet • The denominator. meaningful use as it creates a high this objective an EP or eligible hospital • The required percentage for standard, while still allowing room for should implement five clinical decision demonstrating successful attainment of technical hindrances and other barriers support rules relevant to the clinical an objective. to reaching full compliance. quality metrics described in section The numerator for this objective is the EP/Eligible Hospital Objective: Submit II.A.3 before the end of the EHR number of unique patients age 50 or claims electronically to public and reporting period and attest to that over seen by the EP during the EHR private payers. implementation. EP/Eligible Hospital Measure: At least reporting period who are provided EP/Eligible Hospital Objective: Check 80 percent of all claims filed reminders. A unique patient is insurance eligibility electronically from electronically by the EP or the eligible discussed under the objective of public and private payers. hospital. maintaining an up-to-date problem list. EP/Eligible Hospital Measure: The capability to submit claims We propose to limit the patient Insurance eligibility checked electronically to public and private population for this measure to patients electronically for at least 80 percent of payers is included in the certification age 50 or over as they are more likely all unique patients seen by the EP or criteria for certified EHR technology (to than the norm to require additional admitted to an eligible hospital. be defined by ONC in its upcoming preventive or follow-up care. The The capability to check insurance interim final rule). Meaningful use seeks denominator for this objective is the eligibility electronically is included in to ensure that those capabilities are number of unique patients seen by the the certification criteria for certified utilized. Therefore, we believe in order EP during the EHR reporting period. We EHR technology (to be defined by ONC to meet this objective it is not sufficient propose to set the percentage required in its upcoming interim final rule). to demonstrate this capability once, but for successful demonstration at 50 Meaningful use seeks to ensure that rather to comply with the objective, an percent. While the objective relies on a those capabilities are utilized. EP or eligible hospital must utilize this capability included as part of certified Therefore, we believe in order to meet capability as part of the daily work EHR technology there is still the added this objective it is not sufficient to process. component of determining patient demonstrate this capability once, but As discussed under CPOE, we will preference. Also while we believe we rather to comply with the objective an use a percentage. To calculate the greatly increase the likelihood that EP or eligible hospital must utilize this percentage, CMS and ONC have worked additional preventive or follow up care capability as part of the daily work together to define the following for this will be required by limiting the patient process. objective: population to age 50 or over, there may As discussed under CPOE, we will • The numerator. still be instances where there is not an use a percentage. To calculate the • The denominator. additional preventive or follow up care percentage, CMS and ONC have worked • The required percentage for step needed. For these reasons, we together to define the following for this demonstrating successful attainment of propose the lower threshold of 50 objective: an objective. percent. We specifically invite • The numerator. The numerator for this objective is the comments on whether limiting the • The denominator. number of claims submitted

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electronically using certified EHR that certified EHR technology will this objective it is not sufficient to technology for patients seen by the EP provide EPs and eligible hospitals more demonstrate this capability once, but or admitted to an inpatient facility/ efficient means of providing copies of rather to comply with the objective an department (POS 21) that falls under the health information to patients which is eligible hospital must utilize this eligible hospital’s CCN during the EHR why we have proposed that a request for capability as part of the daily work reporting period. The denominator for an electronic copy be provided to the process. this objective is the number of claims patient within 48 hours. As discussed under CPOE, we will filed seen by the EP or admitted to an As discussed under CPOE, we will use a percentage. To calculate the inpatient facility/department (POS 21) use a percentage. To calculate the percentage, CMS and ONC have worked that falls under the eligible hospital’s percentage, CMS and ONC have worked together to define the following for this CCN during the EHR reporting period. together to define the following for this objective: While this objective relies on the objective: • The numerator. electronic exchange of information, • The numerator. • The denominator. • nearly all public and private payers • The denominator. The required percentage for • accept electronic claims. Given the The required percentage for demonstrating successful attainment of advance state of this aspect of electronic demonstrating successful attainment of an objective. exchange of information, we propose to an objective. The numerator for this objective is the set the percentage required for The numerator for this objective is the number of patients discharged from an successful demonstration at 80 percent. number of patients seen by the EP or inpatient facility/department (POS 21) The additional reasoning for this is the admitted to an inpatient facility/ that falls under the eligible hospital’s same as under CPOE for EPs. Though department (POS 21) that falls under the CCN during the EHR reporting period full compliance (that is, 100 percent) is eligible hospital’s CCN during the EHR that request an electronic copy of their the ultimate goal, 80 percent seemed an reporting period that request an discharge instructions and procedures appropriate standard for Stage 1 electronic copy of their health and receive it. The denominator for this meaningful use as it creates a high information and receive it within 48 objective is the number of patients standard, while still allowing room for hours. The denominator for this discharged from an inpatient facility/ technical hindrances and other barriers objective is the number of patients seen department (POS 21) that falls under the to reaching full compliance. by the EP or admitted to an inpatient eligible hospital’s CCN who request an EP Objective: Provide patients with an facility/department (POS 21) that falls electronic copy of their discharge electronic copy of their health under the eligible hospital’s CCN who instructions and procedures during the information (including diagnostic test request an electronic copy of their EHR reporting period. As this objective results, problem list, medication lists, health information during the EHR relies solely on a capability included as and allergies) upon request. reporting period. As this objective relies part of certified EHR technology and is Eligible Hospital Objective: Provide solely on a capability included as part not, for purposes of Stage 1 criteria, patients with an electronic copy of their of certified EHR technology and is not, reliant on the electronic exchange health information (including diagnostic for purposes of Stage 1 criteria, reliant between health care providers of test results, problem list, medication on the electronic exchange of structured structured information, we propose to lists, allergies, discharge summary, and information between health care set the percentage required for procedures), upon request. providers, we propose to set the successful demonstration at 80 percent. EP/Eligible Hospital Measure: At least percentage required for successful The reasoning for this is the same as 80 percent of all patients who request an demonstration at 80 percent. The under CPOE for EPs. Though full electronic copy of their health reasoning for this is the same as under compliance (that is, 100 percent) is the information are provided it within 48 CPOE for EPs. Though full compliance ultimate goal, 80 percent seemed an hours. (that is, 100 percent) is the ultimate appropriate standard for Stage 1 The capability to create an electronic goal, 80 percent seemed an appropriate meaningful use as it creates a high copy of a patient’s health information is standard for Stage 1 meaningful use as standard, while still allowing room for included in the certification criteria for it creates a high standard, while still technical hindrances and other barriers certified EHR technology (to be defined allowing room for technical hindrances to reaching full compliance. by ONC in its upcoming interim final and other barriers to reaching full EP Objective: Provide patients with rule). Meaningful use seeks to ensure compliance. timely electronic access to their health that those capabilities are utilized. Eligible Hospital Objective: Provide information (including lab results, Therefore, we believe in order to meet patients with an electronic copy of their problem list, medication lists, allergies). this objective it is not sufficient to discharge instructions and procedures at EP Measure: At least 10 percent of all demonstrate this capability once, but time of discharge, upon request. unique patients seen by the EP are rather to comply with the objective, an Eligible Hospital Measure: At least 80 provided timely electronic access to EP or eligible hospital must utilize this percent of all patients who are their health information capability as part of the daily work discharged from an eligible hospital and The capability to provide timely process. In addition, all patients have a who request an electronic copy of their electronic access to health information right under ARRA to an electronic copy discharge instructions and procedures is included in the certification criteria of their health information. This are provided it. for certified EHR technology (to be measure seeks to ensure that this The capability to produce an defined by ONC in its upcoming interim requirement is met in a timely fashion. electronic copy of discharge instructions final rule). Meaningful use seeks to Providing patients with an electronic and procedures is included in the ensure that those capabilities are copy of their health information certification criteria for certified EHR utilized. Therefore, we believe in order demonstrates one of the many benefits technology (to be defined by ONC in its to meet this objective it is not sufficient health information technology can upcoming interim final rule). to demonstrate this capability once, but provide and we believe that it is an Meaningful use seeks to ensure that rather to comply with the objective, an important part of becoming a those capabilities are utilized. EP must utilize this capability as part of meaningful EHR user. We also believe Therefore, we believe in order to meet the daily work process.

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As discussed under CPOE, we will CD or USB fob, or printed copy. The same test multiple times just because use a percentage. To calculate the after-visit clinical summary contains an multiple EPs use the same certified EHR percentage, CMS and ONC have worked updated medication list, laboratory and technology. To be considered an together to define the following for this other diagnostic test orders, procedures ‘‘exchange’’ in this section alone the objective: and other instructions based on clinical clinical information must be sent • The numerator. discussions that took place during the between different clinical entities with • The denominator. office visit. The denominator for this distinct certified EHR technology and • The required percentage for objective is the number of unique not between organizations that share a demonstrating successful attainment of patients seen in the office during the certified EHR. an objective. EHR reporting period. As this objective EP/Eligible Hospital Objective: The numerator for this objective is the relies solely on a capability included as Perform medication reconciliation at number of unique patients seen during part of certified EHR technology and is relevant encounters and each transition the EHR reporting period who have not, for purposes of Stage 1 criteria, of care. timely, electronic access to their health reliant on the electronic exchange of EP/Eligible Hospital Measure: Perform information (for example, have structured information, we propose to medication reconciliation for at least 80 established a user account and set the percentage required for percent of relevant encounters and password on a patient portal). A unique successful demonstration at 80 percent. transitions of care. patient is discussed under the objective The reasoning for this is the same as The capability to perform medication of maintaining an up-to-date problem under CPOE for EPs. Though full reconciliation is included in the list. The denominator for this objective compliance (that is, 100 percent) is the certification standards for certified EHR is the number of unique patients seen ultimate goal, 80 percent seemed an technology (to be defined by ONC in its during the EHR reporting period. We appropriate standard for Stage 1 upcoming interim final rule). recognize that many patients may not meaningful use as it creates a high Meaningful use seeks to ensure that have internet access, may not be able or standard, while still allowing room for those capabilities are utilized. interested to use a patient portal. Health technical hindrances and other barriers Therefore, we believe in order to meet systems that have actively promoted to reaching full compliance. this objective it is not sufficient to such technologies have been able to EP Objective: Capability to exchange demonstrate this capability once, but achieve active use by over 30 percent of key clinical information (for example, rather to comply with the objective, an their patients, but this may not be problem list, medication list, allergies, EP or eligible hospital must utilize this realistic for many practices in the short and diagnostic test results), among capability as part of the daily work term. providers of care and patient authorized process. EP Objective: Provide clinical entities electronically. As discussed under CPOE, we will summaries to patients for each office Eligible Hospital Objective: Capability use a percentage. To calculate the visit. to exchange key clinical information (for percentage, CMS and ONC have worked EP Measure: Clinical summaries example, discharge summary, together to define the following for this provided to patients for at least 80 procedures, problem list, medication objective: percent of all office visits. list, allergies, diagnostic test results), • The numerator. The capability to provide a clinical among providers of care and patient • The denominator. • summary is included in the certification authorized entities electronically. The required percentage for standards for certified EHR technology EP/Eligible Hospital Measure: demonstrating successful attainment of (to be defined by ONC in its upcoming Performed at least one test of certified an objective. interim final rule). Meaningful use seeks EHR technology’s capacity to The numerator for this objective is the to ensure that those capabilities are electronically exchange key clinical number of relevant encounters and utilized. Therefore, we believe in order information. transitions of care for which the EP or to meet this objective it is not sufficient The capability to send key clinical an inpatient facility/department (POS to demonstrate this capability once, but information electronically is included in 21) that falls under the eligible rather to comply with the objective, an the certification criteria for certified hospital’s CCN was a participant during EP must utilize this capability as part of EHR technology (to be defined by ONC the EHR reporting period where the daily work process. in its upcoming interim final rule). medication reconciliation was As discussed under CPOE, we will Meaningful use seeks to ensure that performed. Relevant encounter and use a percentage. To calculate the those capabilities are utilized. However, transition of care are defined in the percentage, CMS and ONC have worked this objective is reliant on the electronic previous discussion of this objective in together to define the following for this exchange of information. We are this proposed rule. The denominator for objective: cognizant that in most areas of the this objective is the number of relevant • The numerator. country, the infrastructure necessary to encounters and transitions of care for • The denominator. support such exchange is still being which the EP or an inpatient facility/ • The required percentage for developed. Therefore, for the Stage 1 department (POS 21) that falls under the demonstrating successful attainment of criteria of meaningful use we propose eligible hospital’s CCN was a participant an objective. that EPs and eligible hospitals test their during the EHR reporting period. As this The numerator for this objective is the ability to send such information at least objective relies solely on a capability number of unique patients seen in the once prior to the end of the EHR included as part of certified EHR office during the EHR reporting period reporting period. The testing could technology and is not, for the purposes who are provided a clinical summary of occur prior to the beginning of the EHR of Stage 1 criteria, reliant on the their visit. A unique patient is discussed reporting period. If multiple EPs are electronic exchange of information, we under the objective of maintaining an using the same certified EHR technology propose to set the percentage required up-to-date problem list. The clinical in a shared physical setting, the testing for successful demonstration at 80 summary can be provided through a would only have to occur once for a percent. The reasoning for this is the PHR, patient portal on the Web site, given certified EHR technology, as we same as under CPOE for EPs. Though secure e-mail, electronic media such as do not see any value to running the full compliance (that is, 100 percent) is

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the ultimate goal, 80 percent seemed an standard for Stage 1 meaningful use as reliant on the electronic exchange of appropriate standard for Stage 1 it creates a high standard, while still information. We are cognizant that in meaningful use as it creates a high allowing room for technical hindrances most areas of the country, the standard, while still allowing room for and other barriers to reaching full infrastructure necessary to support such technical hindrances and other barriers compliance. exchange is still being developed. to reaching full compliance. EP/Eligible Hospital Objective: Therefore, for the Stage 1 criteria of EP/Eligible Hospital Objective: Capability to submit electronic data to meaningful use we propose that eligible Provide summary care record for each immunization registries and actual hospitals test their ability to send such transition of care and referral. submission where required and information at least once prior to the EP/Eligible Hospital Measure: Provide accepted. end of the EHR reporting period. The summary of care record for at least 80 EP/Eligible Hospital Measure: testing could occur prior to the percent of transitions of care and Performed at least one test of certified beginning of the EHR reporting period. referrals. EHR technology’s capacity to submit More stringent requirements may be The capability to provide a summary electronic data to immunization established for hospitals under the of care record is included in the registries. Medicaid program in States where this certification standards for certified EHR The capability to send electronic data capability exists. This is just one technology (to be defined by ONC in its to immunization registries is included example of a possible State proposed upcoming interim final rule). in the certification standards for modification to meaningful use in the Meaningful use seeks to ensure that certified EHR technology (to be defined Medicaid EHR incentive program. States those capabilities are utilized. by ONC in its upcoming interim final may propose any modification or Therefore, we believe in order to meet rule). Meaningful use seeks to ensure addition to CMS in accordance with the this objective it is not sufficient to that those capabilities are utilized. discussion in II.A.2.c. of this proposed demonstrate this capability once, but However, this objective is reliant on the rule. rather to comply with the objective an electronic exchange of information. We EP/Eligible Hospital Objective: EP or eligible hospital must utilize this are cognizant that in many areas of the Capability to provide electronic capability as part of the daily work country, the infrastructure necessary to syndromic surveillance data to public process. support such exchange is still being health agencies and actual transmission As discussed under CPOE, we will developed. Therefore, for the Stage 1 according to applicable law and use a percentage. To calculate the criteria of meaningful use we propose practice. percentage, CMS and ONC have worked that EPs and eligible hospitals test their EP/Eligible Hospital Measure: together to define the following for this ability to send such information at least Performed at least one test of certified objective: once prior to the end of the EHR EHR technology’s capacity to provide • The numerator. reporting period. The testing could electronic syndromic surveillance data • The denominator. occur prior to the beginning of the EHR to public health agencies (unless none • The required percentage for reporting period. EPs in a group setting of the public health agencies to which demonstrating successful attainment of using identical certified EHR technology an EP or eligible hospital submits such an objective. would only need to conduct a single information have the capacity to receive The numerator for this objective is the test, not one test per EP. More stringent the information electronically). number of transitions of care and requirements may be established for EPs The capability to send electronic data referrals for which the EP or an and hospitals under the Medicaid to immunization registries is included inpatient facility/department (POS 21) program in states where this capability in the certification standards for that falls under the eligible hospital’s exists. This is just one example of a certified EHR technology (to be defined CCN was the transferring or referring possible State proposed modification to by ONC in its upcoming interim final provider during the EHR reporting meaningful use in the Medicaid EHR rule). Meaningful use seeks to ensure period where a summary of care record incentive program. States may propose that those capabilities are utilized. was provided. Summary of care record any modification or addition to CMS in However, this objective is reliant on the and transitions of care are defined in the accordance with the discussion in electronic exchange of information. We discussion of this objective in this II.A.2.c. of this proposed rule. are cognizant that in most areas of the proposed rule. The summary of care Eligible Hospital Objective: Capability country, the infrastructure necessary to record can be provided through an to provide electronic submission of support such exchange is still being electronic exchange, accessed through a reportable lab results to public health developed. Therefore, for the Stage 1 secure portal, secure e-mail, electronic agencies and actual submission where it criteria of meaningful use we are media such as CD or USB fob, or printed can be received. proposing that EPs and eligible copy. The denominator for this objective Eligible Hospital Measure: Performed hospitals test their ability to send such is the number of transitions of care for at least one test of certified EHR information at least once prior to the which the EP or an inpatient facility/ technology capacity to provide end of the EHR reporting period. The department (POS 21) that falls under the electronic submission of reportable lab testing could occur prior to the eligible hospital’s CCN was the results to public health agencies (unless beginning of the EHR reporting period. transferring or referring provider during none of the public health agencies to EPs in a group setting using identical the EHR reporting period. As this which eligible hospital submits such certified EHR technology would only objective can be completed with or information have the capacity to receive need to conduct a single test, not one without the use of electronic exchange the information electronically). test per EP. More stringent requirements of information, we propose to set the The capability to send reportable lab may be established for EPs and hospitals percentage required for successful results is included in the certification under the Medicaid program in States demonstration at 80 percent. The standards for certified EHR technology where this capability exists. This is just reasoning for this is the same as under (to be defined by ONC in its upcoming one example of a possible State CPOE for EPs. Though full compliance interim final rule). Meaningful use seeks proposed modification to meaningful (that is, 100 percent) is the ultimate to ensure that those capabilities are use in the Medicaid EHR incentive goal, 80 percent seemed an appropriate utilized. However, this objective is program. States may propose any

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modification or addition to CMS in The capability to protect electronic meaningful use we propose that EPs and accordance with the discussion in health information maintained using eligible hospitals conduct or review a II.A.2.c. of this proposed rule. certified EHR technology is included in security risk analysis of certified EHR EP/Eligible Hospital Objective: Protect the certification standards for certified technology and implement updates as electronic health information EHR technology (to be defined by ONC necessary at least once prior to the end maintained using certified EHR in its upcoming interim final rule). of the EHR reporting period and attest technology through the implementation Meaningful use seeks to ensure that to that conduct or review. The testing of appropriate technical capabilities. those capabilities are utilized. While could occur prior to the beginning of the EP/Eligible Hospital Measure: certified EHR technology provides tools EHR reporting period. This is to ensure Conduct or review a security risk for protecting health information, it is that the certified EHR technology is analysis in accordance with the not a full protection solution. Processes playing its role in the overall strategy of requirements under 45 CFR and possibly tools outside the scope of the EP or eligible hospital in protecting 164.308(a)(1) and implement security certified EHR technology are required. updates as necessary. Therefore, for the Stage 1 criteria of health information.

TABLE 2—STAGE 1 CRITERIA FOR MEANINGFUL USE

Stage 1 objectives Health outcomes policy Care goals Stage 1 measures priority Eligible professionals Hospitals

Improving quality, safety, Provide access to com- Use CPOE ...... Use of CPOE for orders For EPs, CPOE is used for at least efficiency, and reduc- prehensive patient (any type) directly en- 80% of all orders. ing health disparities. health data for pa- tered by authorizing For eligible hospitals, CPOE is used tient’s health care provider (for exam- for 10% of all orders. team. ple, MD, DO, RN, PA, NP). Use evidence-based Implement drug-drug, Implement drug-drug, The EP/eligible hospital has enabled order sets and CPOE. drug-allergy, drug-for- drug-allergy, drug-for- this functionality. mulary checks. mulary checks. Apply clinical decision Maintain an up-to-date Maintain an up-to-date At least 80% of all unique patients support at the point problem list of current problem list of current seen by the EP or admitted to the of care. and active diagnoses and active diagnoses eligible hospital have at least one Generate lists of pa- based on ICD–9–CM based on ICD–9–CM entry or an indication of none re- tients who need care or SNOMED CT®. or SNOMED CT®. corded as structured data. and use them to reach out to patients. Report information for Generate and transmit ...... At least 75% of all permissible pre- quality improvement permissible prescrip- scriptions written by the EP are and public reporting. tions electronically transmitted electronically using cer- (eRx). tified EHR technology. Maintain active medica- Maintain active medica- At least 80% of all unique patients tion list. tion list. seen by the EP or admitted to the eligible hospital have at least one entry (or an indication of ‘‘none’’ if the patient is not currently pre- scribed any medication) recorded as structured data. Maintain active medica- Maintain active medica- At least 80% of all unique patients tion allergy list. tion allergy list. seen, by the EP or admitted to the eligible hospital have at least one entry or (an indication of ‘‘none’’ if the patient has no medication aller- gies) recorded as structured data. Record demographics .. Record demographics .. At least 80% of all unique patients Æ preferred language Æ preferred language seen by the EP or admitted to the Æ insurance type Æ insurance type eligible hospital have demographics Æ gender Æ gender recorded as structured data. Æ race Æ race Æ ethnicity Æ ethnicity Æ date of birth Æ date of birth Æ date and cause of death in the event of mortality

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TABLE 2—STAGE 1 CRITERIA FOR MEANINGFUL USE—Continued

Stage 1 objectives Health outcomes policy Care goals Stage 1 measures priority Eligible professionals Hospitals

Record and chart Record and chart For at least 80% of all unique patients changes in vital changes in vital age 2 and over seen by the EP or signs: signs: admitted to eligible hospital, record Æ height Æ height blood pressure and BMI; addition- Æ weight Æ weight ally plot growth chart for children Æ blood pressure Æ blood pressure age 2–20. Æ Calculate and display: Æ Calculate and display: BMI. BMI. Æ Plot and display Æ Plot and display growth charts for chil- growth charts for chil- dren 2–20 years, in- dren 2–20 years, in- cluding BMI. cluding BMI. Record smoking status Record smoking status At least 80% of all unique patients 13 for patients 13 years for patients 13 years years old or older seen by the EP old or older. old or older. or admitted to the eligible hospital have ‘‘smoking status’’ recorded. Incorporate clinical lab- Incorporate clinical lab- At least 50% of all clinical lab tests or- test results into EHR test results into EHR dered whose results are in a posi- as structured data. as structured data. tive/negative or numerical format are incorporated in certified EHR technology as structured data. Generate lists of pa- Generate lists of pa- Generate at least one report listing tients by specific con- tients by specific con- patients of the EP or eligible hos- ditions to use for ditions to use for pital with a specific condition. quality improvement, quality improvement, reduction of dispari- reduction of dispari- ties, and outreach. ties, and outreach. Report ambulatory Report hospital quality For 2011, provide aggregate numer- quality measures to measures to CMS or ator and denominator through attes- CMS or the States. the States. tation as discussed in section II(A)(3) of this proposed rule. For 2012, electronically submit the measures as discussed in section II(A)(3) of this proposed rule. Send reminders to pa- ...... Reminder sent to at least 50% of all tients per patient unique patients seen by the EP that preference for pre- are age 50 or over. ventive/follow up care. Implement 5 clinical de- Implement 5 clinical de- Implement 5 clinical decision support cision support rules cision support rules rules relevant to the clinical quality relevant to specialty related to a high pri- metrics the EP/Eligible Hospital is or high clinical pri- ority hospital condi- responsible for as described further ority, including diag- tion, including diag- in section II(A)(3). nostic test ordering, nostic test ordering, along with the ability along with the ability to track compliance to track compliance with those rules. with those rules. Check insurance eligi- Check insurance eligi- Insurance eligibility checked electroni- bility electronically bility electronically cally for at least 80% of all unique from public and pri- from public and pri- patients seen by the EP or admitted vate payers. vate payers. to the eligible hospital. Submit claims electroni- Submit claims electroni- At least 80% of all claims filed elec- cally to public and cally to public and tronically by the EP or the eligible private payers. private payers. hospital. Engage patients and Provide patients and Provide patients with an Provide patients with an At least 80% of all patients who re- families in their health families with timely electronic copy of electronic copy of quest an electronic copy of their care. access to data, their health informa- their health informa- health information are provided it knowledge, and tools tion (including diag- tion (including diag- within 48 hours. to make informed de- nostic test results, nostic test results, cisions and to man- problem list, medica- problem list, medica- age their health. tion lists, allergies), tion lists, allergies, upon request. discharge summary, procedures), upon re- quest.

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TABLE 2—STAGE 1 CRITERIA FOR MEANINGFUL USE—Continued

Stage 1 objectives Health outcomes policy Care goals Stage 1 measures priority Eligible professionals Hospitals

Provide patients with an At least 80% of all patients who are electronic copy of discharged from an eligible hospital their discharge in- and who request an electronic copy structions and proce- of their discharge instructions and dures at time of dis- procedures are provided it. charge, upon request. Provide patients with ...... At least 10% of all unique patients timely electronic ac- seen by the EP are provided timely cess to their health electronic access to their health in- information (including formation. lab results, problem list, medication lists, allergies) within 96 hours of the informa- tion being available to the EP. Provide clinical sum- ...... Clinical summaries are provided for at maries for patients least 80% of all office visits. for each office visit. Improve care coordina- Exchange meaningful Capability to exchange Capability to exchange Performed at least one test of certified tion. clinical information key clinical informa- key clinical informa- EHR technology’s capacity to elec- among professional tion (for example, tion (for example, dis- tronically exchange key clinical in- health care team. problem list, medica- charge summary, formation. tion list, allergies, di- procedures, problem agnostic test results), list, medication list, among providers of allergies, diagnostic care and patient au- test results), among thorized entities elec- providers of care and tronically. patient authorized en- tities electronically. Perform medication rec- Perform medication rec- Perform medication reconciliation for onciliation at relevant onciliation at relevant at least 80% of relevant encounters encounters and each encounters and each and transitions of care. transition of care. transition of care. Provide summary care Provide summary care Provide summary of care record for at record for each tran- record for each tran- least 80% of transitions of care and sition of care and re- sition of care and re- referrals. ferral. ferral. Improve population and Communicate with pub- Capability to submit Capability to submit Performed at least one test of certified public health. lic health agencies. electronic data to im- electronic data to im- EHR technology’s capacity to sub- munization registries munization registries mit electronic data to immunization and actual submis- and actual submis- registries. sion where required sion where required and accepted. and accepted. Capability to provide Performed at least one test of the electronic submission EHR system’s capacity to provide of reportable lab re- electronic submission of reportable sults (as required by lab results to public health agencies state or local law) to (unless none of the public health public health agen- agencies to which eligible hospital cies and actual sub- submits such information have the mission where it can capacity to receive the information be received. electronically). Capability to provide Capability to provide Performed at least one test of certified electronic syndromic electronic syndromic EHR technology’s capacity to pro- surveillance data to surveillance data to vide electronic syndromic surveil- public health agen- public health agen- lance data to public health agencies cies and actual trans- cies and actual trans- (unless none of the public health mission according to mission according to agencies to which an EP or eligible applicable law and applicable law and hospital submits such information practice. practice. have the capacity to receive the in- formation electronically).

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TABLE 2—STAGE 1 CRITERIA FOR MEANINGFUL USE—Continued

Stage 1 objectives Health outcomes policy Care goals Stage 1 measures priority Eligible professionals Hospitals

Ensure adequate privacy Ensure privacy and se- Protect electronic Protect electronic Conduct or review a security risk and security protec- curity protections for health information health information analysis per 45 CFR 164.308(a)(1) tions for personal confidential informa- created or maintained created or maintained and implement security updates as health information. tion through oper- by the certified EHR by the certified EHR necessary. ating policies, proce- technology through technology through dures, and tech- the implementation of the implementation of nologies and compli- appropriate technical appropriate technical ance with applicable capabilities. capabilities. law. Provide transparency of data sharing to pa- tient.

e. Request for Public Comment on by providers through CPOEs but also the measures is discussed in section Potential Health IT Functionality electronic transmission of those orders; II.A.2.d.2 of this proposed rule and the Measures for Eligible Professionals and • ‘‘Incorporate clinical lab-test results other two requirements are discussed in Eligible Hospitals in 2013 Payment Year into EHR as structured data’’ will be section II.A.2.d.1 of this proposed rule. and Subsequent Years expanded to include the full array of b. Requirements for the Submission of As noted previously, we are cognizant diagnostic test data used for the treatment and diagnosis of disease, Clinical Quality Measures by EPs and that in most areas of the country, the Eligible Hospitals infrastructure necessary to support the where feasible, including blood tests, electronic exchange of structured microbiology, urinalysis, pathology Sections 1848(o)(2)(B)(ii) and information is not yet currently tests, radiology, cardiac imaging, 1886(n)(3)(B)(ii) of the Act provide that available. For that reason, we excluded nuclear medicine tests, and pulmonary the Secretary may not require the the electronic exchange of structured function tests; electronic reporting of information on • Measures that currently allow the information from many Stage 1 clinical quality measures unless the provision and exchange of unstructured objectives or set relatively low Secretary has the capacity to accept the data (for example, the provision of performance thresholds for measures information electronically, which may clinical care summaries on paper) will that do rely on the electronic exchange be on a pilot basis. require the provision and exchange of of structured data. For example, we set We do not anticipate that HHS will electronic and structured data, where the threshold at 50 percent for the complete the necessary steps for us to feasible; incorporation of lab data in structured have the capacity to electronically • Measures that currently require the accept data on clinical quality measures format, and we excluded other types of performance of a capability test (for diagnostic test data (for example, from EHRs for the 2011 payment year. example, capability to provide It is unlikely that by 2011 there will be radiology reports, pathology reports, electronic syndromic surveillance data etc.) from that measure. We also adequate testing and demonstration of to public health agencies) will be the ability to receive the required excluded the transmission of orders revised to require the actual submission ‘‘ ’’ transmitted information on a from the definition of CPOE use for of that data; Stage 1 criteria. widespread basis. The capacity to In future rulemaking (for example, for We invite comment on our intent to accept information on clinical quality Stage 2 and Stage 3 criteria), however, propose the above measure for Stage 2 measures also depends upon the we anticipate raising the threshold for in future rulemaking and also invite Secretary promulgating technical these objectives as the capabilities of comment on any other health IT specifications for EHR vendors with HIT infrastructure increases. We also functionality measures not included in respect to the transmission of anticipate redefining our objectives to this list. information on clinical quality measures include not only the capturing of data 3. Sections 4101(a) and 4102(a)(1) of sufficiently in advance of the EHR in electronic format but also the HITECH Act: Reporting on Clinical reporting period for 2011, so that exchange (both transmission and Quality Measures Using EHRs by EPs adequate time has been provided either receipt) of that data in increasingly and Eligible Hospitals for such specifications to be certified, or structured formats. The intent and for EHR vendors to code such a. General policy goal with raising these thresholds specifications into certified systems. and expectations is to ensure that As discussed in the meaningful use Therefore, for 2011, we propose that EPs meaningful use encourages patient- background section, there are three and eligible hospitals use an attestation centric, interoperable health elements of meaningful use. In this methodology to submit summary information exchange across provider section, we discuss the third information to CMS on clinical quality organizations regardless of provider’s requirement using its certified EHR measures as a condition of business affiliation or EHR platform. technology, the EP or eligible hospital demonstrating meaningful use of We specifically intend to build up the submits to the Secretary, in a form and certified EHR technology. following health IT functionality manner specified by the Secretary, From the Medicaid perspective, measures for Stage 2 meaningful use information for the EHR reporting delaying the onset of clinical quality criteria: period on clinical quality measures and measures reporting until 2012 addresses • ‘‘CPOE use’’ will include not only other measures specified by the concerns about States having the ready the percentage of orders entered directly Secretary. The submission of other infrastructure to receive and store

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clinical quality measures data before electronically, as well as other statutory 1848(o)(2)(A)(i) and 1886(n)(3)(A)(ii) of then. More importantly, we recognize requirements for clinical quality the Act that EPs and eligible hospitals that since Medicaid providers are measures that are discussed below in use certified EHR technology to capture eligible to receive incentive payments section II.A.3.c.1 of this proposed rule. the data elements and calculate the for adopting, implementing, or These limitations apply solely to the results for the applicable clinical quality upgrading certified EHR technology. submission of clinical quality measures, measures discussed below. We further Medicaid EPs may not be focused on and do not apply to other measures of propose that EPs and eligible hospitals demonstrating meaningful use until meaningful EHR use. The proposed demonstrate that they have satisfied this 2012 or later. clinical quality measures on which EPs requirement during the EHR reporting We anticipate that for the 2012 or eligible hospitals will be required to period for 2011 through attestation. We payment year we will have completed submit information using certified EHR further propose to require that Medicare the necessary steps to have the capacity technology, the statutory requirements to receive electronically information on and other considerations that were used EPs and eligible hospital attest to the clinical quality measures from EHRs to select these proposed measures, and accuracy and completeness of the including the promulgation of technical the proposed reporting requirements are numerators and denominators for each specifications for EHR vendors to use described below. of the applicable measure. Finally, in for obtaining certification of their With respect to Medicaid EPs and accordance with our authority under systems. Therefore, for the Medicare eligible hospitals, we note that section sections 1848(o)(C)(i)(V) and EHR incentive program, we propose that 1903(t)(6) of the Act recognizes that the 1886(n)(3)(C)(i)(V) of the Act, which beginning in CY 2012 an EP using a demonstration of meaningful use may grants us broad discretion to specify the certified EHR technology or beginning also include the reporting of clinical means through which EPs and eligible in FY 2012 an eligible hospital using a quality measures to the States. In the hospitals demonstrate compliance with certified EHR technology, as appropriate interest of simplifying the program and the meaningful use criteria, we propose for clinical quality measures, must guarding against duplication of that EPs and eligible hospitals submit information on clinical quality meaningful use criteria, we propose that demonstrate their use of certified EHR measures electronically in addition to the clinical quality measures adopted technology to capture the data elements submitting other measures described in for the Medicare EHR incentive and calculate the results for the section II.2.d.2 of this proposed rule in program, listed in Tables 3 and 20, will applicable clinical quality measures by order for the EP or eligible hospital to also apply to EPs and eligible hospitals reporting the results to CMS for all be a meaningful EHR user, regardless of in the Medicaid EHR incentive program. applicable patients. For the Medicaid whether CY 2012 is their first or second However, we are including alternative incentive program, States may accept payment year. However, if the Secretary Medicaid-specific measures for use by does not have the capacity to accept the eligible hospitals as shown in Table 21. provider attestations in the same information on clinical quality measures Despite the statutory limitation manner to demonstrate meaningful use electronically in 2012, consistent with prohibiting the Secretary from requiring in 2011. However, we expect that sections 1848(o)(2)(B)(ii) and the electronic submission of clinical Medicaid providers will qualify for the 1886(n)(3)(B)(ii) of the Act, we will quality measures if HHS does not have incentive payment by adopting, continue to rely on an attestation the capacity to accept this information implementing, or upgrading to certified methodology for reporting of clinical electronically, as previously discussed, EHR technology, and therefore; will not quality measures as a requirement for the Secretary has broad discretion to need to attest to meaningful use of EHRs demonstrating meaningful use of establish requirements for meaningful in 2011, for their first payment year. certified EHR technology for payment use of certified EHR technology and for We recognize that considerable work year 2012. Should we not have the the demonstration of such use by EPs needs to be done by measure owners and eligible hospitals. Although we capacity to accept information on and developers with respect to the clinical quality measures electronically propose to first require the electronic clinical quality measures included in in 2012, we will inform the public of submission of information on clinical this proposed rule. This includes this fact by publishing a notice in the quality measures in 2012, we do not Federal Register and providing desire this to delay the use of certified completing electronic specifications for instructions on how this information EHR technology by EPs and eligible measures, implementing such should be submitted to us. hospitals to measure and improve specifications into EHR technology to For purposes of the requirements clinical quality. Specifically, we believe capture and calculate the results, and under sections 1848(o)(2)(A)(iii) and that the use of those functionalities that implementing the systems, themselves. 1886 (n)(3)(iii) of the Act, we define support measurement of clinical quality We also recognize that some measures ‘‘clinical quality measures’’ to consist of is highly important to an overall goal of are further developed than others, as measures of processes, experience, and/ the HITECH Act, to improve health care discussed in the proposed measures or outcomes of patient care, quality. We believe that measurement section. Nevertheless, we believe that observations or treatment that relate to and acting on the results of such overall there is sufficient time to one or more quality aims for health care measurement is an important aspect to complete work on measures and such as effective, safe, efficient, patient- improving quality. measures specifications to allow centered, equitable, and timely care. We Accordingly, although we are not vendors, and EPs and eligible hospitals note that certain statutory limitations proposing under sections to implement such systems. Should the apply only to the reporting of clinical 1848(o)(2)(A)(iii) and 1886(n)(3)(A)(iii) necessary work on measure quality measures, such as the of the Act to require that for 2011 EPs specification not be completed for requirement discussed in the previous and eligible hospitals report clinical particular measures according to the paragraph prohibiting the Secretary quality measures to CMS or States timetable we discuss below, it is our from requiring the electronic reporting electronically, we propose to require as of information on clinical quality an additional condition of intent not to finalize those specific measures unless the Secretary has the demonstrating meaningful use of measures. capacity to accept the information certified EHR technology under sections

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c. Statutory Requirements and Other quality measures eligible hospitals must incentive program clinical quality Considerations for the Proposed report in order to demonstrate measures for eligible hospitals on the Selection of Clinical Quality Measures meaningful use of certified EHR CMS Web site on or before April 1, Proposed for Electronic Submission by technology in accordance with section 2010. We intend that a detailed EPs or Eligible Hospitals 1886(n)(3)(B)(i)(I) of the Act, we propose specifications document for all 2012 (1) Statutory Requirements for the to give preference to the clinical quality payment year Medicare EHR incentive Selection of Clinical Quality Measures measures selected from those endorsed program clinical quality measures for Proposed for Electronic Submission by by the NQF or that have previously been EPs be posted on the our Web site on EPs and Eligible Hospitals selected for the RHQDAPU program. In or before April 1, 2011. This would some instances we have proposed provide final specifications documents Sections 1848(o)(2)(B)(i)(II) and measures for EPs and eligible hospitals at least 9 months in advance of the start 1886(n)(3)(B)(i) of the Act also require that are not currently NQF endorsed in of the applicable payment year for that prior to any clinical quality an effort to include a broader set of clinical quality measure EHR reporting measure being selected, the Secretary clinical quality measures. However, the period. We invite comments on our will publish in the Federal Register HITECH Act does not require the use of proposed timelines to post specification such measure and provide for a period NQF endorsed measures, nor limit the documents for these clinical quality of public comment on such measure. measures to those included in PQRI or measures to the CMS Web site. The proposed clinical quality measures RHQDAPU. If we, professional societies, (2) Other Considerations for the for EPs and eligible hospitals for 2011 or other stakeholders identify clinical and 2012 payment are listed in Tables Proposed Selection of Clinical Quality quality measures which may be 3 through 21. Measures for Electronic Submission by appropriate for the EHR incentive For purposes of selecting clinical EPs and Eligible Hospitals quality measures on which EPs will be programs, we will consider those In addition to the requirements under required to submit information using measures even if they are not endorsed sections 1848(o)(2)(B)(i)(I) and certified EHR technology, section by the NQF or have not been selected 1886(n)(3)(B)(i)(I) of the Act and the 1848(o)(2)(B)(i)(I) of the Act, as added for the PQRI or RHQDAPU programs, by section 4101 of the HITECH Act, subject to the requirement to publish in other statutory requirements described states that the Secretary shall provide the Federal Register such measure(s) for above, other considerations that we preference to clinical quality measures a period of public comment. applied to the selection of the proposed that have been endorsed by the entity We propose the clinical quality clinical quality measures for electronic with a contract with the Secretary under measures for EPs and eligible hospitals submission under the Medicare and section1890(a) of the Act, as added by in Tables 3 through 21 of this proposed Medicaid EHR incentive programs section 183 of the Medicare rule for use in the 2011 and 2012 include the following: • Improvement for Patients and Providers payment years for the Medicare EHR Clinical quality measures that are Act (MIPPA) of 2008. For submission of incentive program will be effective 60 included in, facilitate alignment with, or clinical quality measures by eligible days after the publication of the final allow determination of satisfactory hospitals, section 1886(n)(3)(B)(i)(I) of rule in the Federal Register. No changes reporting in other Medicare (for the Act, as added by section 4102(a) of (that is, additions or deletions of clinical example, PQRI or the RHQDAPU the HITECH Act, requires the Secretary quality measures) will be made after program), Medicaid, and Children’s to provide preference to those clinical publication of the final rule, except Health Insurance Program (CHIP) quality measures that have been through further rulemaking. However, program priorities. endorsed by the entity with a contract we may make administrative and/or • Clinical quality measures that are with the Secretary under subsection technical modifications or refinements, widely applicable to EPs and eligible 1890(a) of the Act, as added by section such as revisions to the clinical quality hospitals based on the services provided 183 of the MIPPA, or clinical quality measures titles and code additions, for the population of patients seen. measures that have been selected for the corrections, or revisions to the detailed • Clinical quality measures that purpose of applying section specifications for the 2011 and 2012 promote CMS and HHS policy priorities 1886(b)(3)(B)(viii) of the Act (that is, payment year measures. The 2011 related to improved quality and measures that have been selected for the specifications for user submission of efficiency of care for the Medicare and Reporting Hospital Quality Data for clinical quality measures will be Medicaid populations that would allow Annual Payment Update (RHQDAPU) available on our Web site when they are us to track improvement in care over program. sufficiently developed or finalized. time. These current and long term On January 14, 2009, the U.S. Specifications for the EHR incentive priority topics include: Prevention; Department of Health and Human programs, even if already published as management of chronic conditions; high Services awarded the contract required a part of another incentive payment cost and high volume conditions; under section 1890(a) of the Act to the programs, must be obtained only from elimination of health disparities; National Quality Forum (NQF). the specifications documents for the healthcare-associated infections and Therefore, when selecting the clinical EHR incentive program clinical quality other conditions; improved care quality measures EPs must report in measures. We note also that the final coordination; improved efficiency; order to demonstrate meaningful use of clinical quality measure specifications improved patient and family experience certified EHR technology in accordance for eligible hospitals for any given of care; improved end-of-life/palliative with section 1848(o)(2)(B)(i)(I) of the clinical quality measure may be care; effective management of acute and Act, we propose to give preference to different from specifications for the chronic episodes of care; reduced the clinical quality measures endorsed same clinical quality measure used for unwarranted geographic variation in by the NQF, including NQF endorsed the previously described testing of EHR- quality and efficiency; and adoption and measures that have previously been based data submission. We are targeting use of interoperable HIT. selected for the Physician Quality finalization and publication of the • Clinical quality measures that Reporting Initiative (PQRI) program. detailed specifications documents for all address or relate to known gaps in the Similarly when selecting the clinical 2011 payment year Medicare EHR quality of care and measures that

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through the PQRI program, performed at not yet NQF-endorsed. New or To the extent that the same clinical low or highly variable rates. additional measures for the next quality measures are used in the PQRI • Clinical quality measures that have iteration of the CHIPRA core set will and RHQDAPU programs and for EHR been recommended to CMS for have EHR-extractability as a priority. meaningful use, we believe that this inclusion in the EHR incentive by FACA The full CHIPRA core measure set will approach would be consistent with the committees, such as the HIT Policy be published for comment in a statutory requirement to avoid duplicate Committee. forthcoming Federal Register notice that reporting to the extent practicable. We In addition, we note that the statutory is expected out before the end of the believe that allowing the measures requirements under sections 1848(o) year. reporting for the PQRI and RHQDAPU and 1886(n) of the Act discussed above However, as many providers, program to be reported via EHRs would do not provide guidance with respect to including primary care professionals, provide an added incentive for EPs and the development of the clinical quality hospitals, dentists, and specialists eligible hospitals to adopt EHRs. measures which may then be submitted provide care to the pediatric population to the NQF for endorsement. The basic in the Medicaid and CHIP programs. We In addition, we do not intend to use steps for developing clinical quality saw consistency as paramount to avoid notice and comment rulemaking as a measures applicable to EPs may be redundancy and duplication for these means to update or modify clinical carried out by a variety of different providers and States. quality measure specifications. A organizations. We do not believe there Provider quality measure reporting clinical quality measure that has needs to be any special restrictions on under CHIPRA for this initial core completed the consensus process the type or infrastructure of the measure set will initially be voluntary. through NQF has a designated party organizations carrying out this basic The intent is to begin standardizing (usually, the measure developer/owner) development of EP or eligible hospital measurement data collection. Due to the who has accepted responsibility for measures, such as restricting the initial concurrent CHIPRA and ARRA HIT maintenance of the clinical quality development to EP or eligible hospital implementation activities, we believe measure. In general, it is the role of the organizations. Any such restriction there is an exciting opportunity to align clinical quality measure owner, would unduly limit the basic the two programs and strive to create developer, or maintainer to make basic development of clinical quality efficiencies for States and pediatric changes to a clinical quality measure in measures, and the scope and utility of providers, where applicable. As both terms of the numerator, denominator, such measures that may be considered programs move forward, we will and exclusions. However, the clinical for NQF endorsement as voluntary continue to prioritize consistency in quality measures selected for the 2011 consensus standards. measure selection for pediatric and 2012 payment year will be With respect to the Children’s Health providers when possible. supplemented by CMS technical Insurance Program Reauthorization Act We welcome comments on the specifications for EHR submission. As (CHIPRA) of 2009 (Pub. L. 111–3) Title inclusion or exclusion of any given discussed earlier, we propose to post the IV, section 401 requires that the clinical quality measure or measures complete clinical quality measures Secretary publish a core set of clinical proposed herein in the EHR incentive specifications including technical quality measures for the pediatric programs clinical quality measure set specifications on our Web site and population. To the extent possible, we for EPs or eligible hospitals for the 2011 solicit comment on our approach. will align the clinical quality measures and 2012 payment years, and to our selected under this Medicaid EHR approach in selecting clinical quality d. Proposed Clinical Quality Measures incentive program with the measures measures. Our goal is for EPs and for Electronic Submission Using selected under the CHIPRA core eligible hospitals to use EHRs to Certified EHR Technology by EPs measure set. Included in the proposed transmit clinical quality measures to the definition of meaningful use are nine Secretary that would allow For the 2011 and 2012 EHR reporting proposed clinical quality measures that determination of their satisfactory periods, based upon the considerations pertain to pediatric providers. Four of reporting under the PQRI and for selecting clinical quality measures the nine measures are also on the list of RHQDAPU programs. Even if the discussed above, we propose the set of CHIPRA initial core measures that were clinical quality measures are not the clinical quality measures identified in recommended to the Secretary by the same for PQRI and RHQDAPU Table 3. The Table 3 lists the applicable Subcommittee to AHRQ’s National satisfactory reporting and EHR PQRI and NQF measure number, title, Advisory Committee (SNAC). Not all meaningful use, our aim is to encourage description, the owner/developer, and a CHIPRA initial measures recommended EPs and eligible hospitals to use EHRs link to existing electronic specifications to the Secretary are applicable to EHR as the mechanism to report PQRI and where applicable. Tables 4 through 19 technology or to the Medicaid EHR RHQDAPU measures rather than describes further the reporting incentive payment program. For reporting measures on claims and other requirements of the Core and Specialty example, some of the measures are reporting mechanisms. We plan to move measure groups. population-based, survey-derived, or to this approach as soon as practicable. BILLING CODE 4210–01–P

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BILLING CODE 4120–01–C

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As previously stated, we believe that (PQRI numbers 1, 2, 3, 5, 7, 110, 111, In summary, we believe that this there is sufficient time to implement the 112, and 113) have specifications for the initial set of clinical quality measures is measures in EHR systems for 2011 electronic submission of these clinical broad enough to allow for reporting for through 2012. However, we recognize quality measures have already been EPs and addresses high priority also that there are measures that we developed for the purpose of testing the conditions. We recognize the propose, which are in a lower state of electronic submission of clinical quality importance of integrating the measures readiness, for implementation in data extracted from an EHR for the PQRI into certified EHR products for certified EHR’s and present a higher program. The user specifications for the calculation of measures results, and that degree of risk in terms of completion of electronic submission of these 9 clinical not all measures may be feasible for the necessary work. We would note that quality measures for the most current 2011 and 2012. We invite comment on the purpose of this quality reporting is PQRI program year can be found on the the advisability of including the to begin the process of quality PQRI section of the CMS Web site at _ measures proposed for payment years benchmarking and iterative http://www.cms.hhs.gov/PQRI/20 2011 and 2012. Although we recognize improvements in the ability of providers AlternativeReportingMechanisms.asp# many other important clinical quality to benchmark themselves against their TopOfPage. measures of health care provided by In terms of CMS and HHS healthcare peers. As part of the public comment EPs, we anticipate expanding the set of process, we welcome comment on not quality priorities, clinical quality PQRI clinical quality measures in future years only the clinical utility of the measures measures numbered 1, 2, 3, 5, and 7 and list a number of clinical quality we have proposed, but also their state of address high priority chronic measures for future consideration in readiness for use in the EHR incentive conditions, namely diabetes, coronary programs. For those measures where artery disease, and heart disease. section II.A.3.g of this preamble, on electronic specifications do not Clinical quality PQRI measures which we also invite comment. currently exist, we solicit comment on numbered 110, 111, 112, 113, 114, 115, We invite comments on our proposed how quickly electronic specifications and 128 support prevention which is a clinical quality measures for EPs. can be developed and the period of time high CMS and HHS priority. The PQRI that might be required for effective clinical quality measure specifications e. Clinical Quality Measures Reporting implementation from the time the for claims-based or registry-based Criteria for EPs electronic specifications of final submission of these clinical quality For the 2011 and 2012 EHR reporting measures are posted and made available measures for the most current PQRI periods, to satisfy the requirements for program year can be found on the PQRI to vendors. We intend to publish reporting on clinical quality measures section of the CMS Web site at http:// electronic specifications for the for Medicare under section www.cms.hhs.gov/PQRI/15_ proposed clinical quality measures on 1848(o)(2)(A)(i) and (iii) of the Act and the CMS Web site as soon as they MeasuresCodes.asp#TopOfPage. A for Medicaid under section 1903(t)(6)(C) become available from the measure description of the clinical quality of the Act for the 2012 payment year, we developer(s). Electronic specifications measure, including the clinical quality propose to require each EP submit may be developed concurrently with the measure’s numerator and denominator, development of measures themselves can be found in the PQRI clinical information on two measure groups, as and potentially with the NQF quality measure specifications. shown in Table 4 and Tables 5 through endorsement processes. The PQRI clinical quality measures 19, of this proposed rule. These are the All of the PQRI measures included in that we have included largely align with core measures group in Table 4, and the the above clinical quality measures meet the recommendations of the HIT subset of clinical measures most one or more of the criteria previously Standards Committee. However, we appropriate given the EPs specialty as discussed. These measures have been have also included certain clinical described further in Tables 5 through 19 through notice and comment quality measures not part of PQRI that specialty group measures below. For the rulemaking for PQRI. Nearly all we believe are of high importance to the core measure group, in Table 4, we proposed PQRI clinical quality overall population. These clinical believe that the clinical quality measures are NQF endorsed. quality measures are IVD: Use of measures are sufficiently general in Additionally, they have broad Aspirin or another Antithrombotic; IVD: application and of such importance to applicability to the range of Medicare Complete Lipid Profile; IVD: Low population health, we propose to designated specialties, and the services Density Lipoprotein (LDL–C) Control, require that all EPs treating Medicare provided by EPs who render services to and Blood Pressure Management. and Medicaid patients in the Medicare and Medicaid beneficiaries Finally, we have included an array of ambulatory setting report on all of the and many others. Further, 9 of the 90 other measures which address core measures as applicable for their clinical quality measures listed above important aspects of clinical quality. patients.

TABLE 4—MEASURE GROUP: CORE FOR ALL EPS, MEDICARE OR MEDICAID

Measure No. Clinical quality measure title

PQRI 114 ...... Title: Preventive Care and Screening: Inquiry Regarding Tobacco Use. NQF 0028 ...... NQF 0013 ...... Title: Blood pressure measurement. NQF 0022 ...... Title: Drugs to be avoided in the elderly: a. Patients who receive at least one drug to be avoided. b. Patients who receive at least two different drugs to be avoided.

The second required measure set for least one of the sets listed in Tables 5 specialty groups are Cardiology, each EP is to submit information on at and 19 as specialty groups. The Pulmonology, Endocrinology, Oncology,

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Proceduralist/Surgery, Primary Care to measures groups used in PQRI which, required for reporting for the second Physicians, Pediatrics, Obstetrics and however, are based on clinical payment year. We invite comment on Gynecology, Neurology, Psychiatry, conditions, rather than specialty types. whether there are EPs who believe no Ophthalmology, Podiatry, Radiology, The general purpose of each type of specialty group will be applicable to Gastroenterology, and Nephrology. measures grouping is to have them. In accordance with public We recognize that clinical quality standardized sets of measures all of comments, we will specify in the final measures as specified by measures which must be reported by the EP in rule which EP specialties will be developers and as endorsed by the NQF order to meet the reporting exempt from selecting and reporting on are not specialty specific. Rather, the requirements. We expect to narrow a specialty measures group. EPs that are denominator of clinical quality down each proposed set to a required so-designated will be required to attest, measures and the applicability of a subset of 3 to 5 measures based on the to CMS or the State, to the measure is determined by the patient availability of electronic measure inapplicability of any of the specialty population to whom the measure specifications and comments received. groups and will not be required to applies and the services rendered by the We propose to require for 2011 and report information on clinical quality particular EP. 2012 that EP’s will select a specialty measures from a specialty group for Nevertheless, we have grouped measures group, on which to report on 2011 or 2012, though the EP will still be measures according to the types of all applicable cases for each of the required to report information on all of patients commonly treated and services measures in the specialty group. The the clinical quality measures listed in rendered by EPs of various specialties. same specialty measures group selected the core measure set in, Table 4, as We have done this for purposes similar for the first payment year would be applicable for their patients.

TABLE 5—MEASURE GROUP: CARDIOLOGY

Measure No. Clinical quality measure title

PQRI 5 ...... Title: Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker NQF 0081 (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD). PQRI 6 ...... Title: Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD. NQF 0067 PQRI 7 ...... Title: Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarc- NQF 0070 tion (MI). PQRI 8 ...... Title: Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD). NQF 0083 PQRI 118 ...... Title: Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Re- NQF 0066 ceptor Blocker (ARB) Therapy for Patients with CAD and Diabetes and/or Left Ventricular Systolic Dys- function (LVSD). PQRI 128 ...... Title: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up. NQF 0421 PQRI 197 ...... Title: Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol. NQF 0074 PQRI 200 ...... Title: Heart Failure: Warfarin Therapy Patients with Atrial Fibrillation. NQF 0084 PQRI 204 ...... Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic. NQF 0068 Not applicable ...... Title: Statin after Myocardial Infarction.

TABLE 6—MEASURE GROUP: PULMONOLOGY

Measure No. Clinical quality measure title

PQRI 52 ...... Title: Chronic Obstructive Pulmonary Disease (COPD): Bronchodilator Therapy. NQF 0102 PQRI 53 ...... Title: Asthma: Pharmacologic Therapy. NQF 0047 PQRI 111 ...... Title: Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older. NQF 0043 PQRI 114 ...... Title: Preventive Care and Screening: Inquiry Regarding Tobacco Use. NQF 0028 PQRI 115 ...... Title: Preventive Care and Screening: Advising Smokers to Quit. NQF 0027 NQF 0001 ...... Title: Asthma assessment. NQF 0036 ...... Title: Use of appropriate medications for people with asthma. Not applicable ...... Title: Use of CT scans.

TABLE 7—MEASURE GROUP: ENDOCRINOLOGY

Measure No. Clinical quality measure title

PQRI 1 ...... Title: Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus. NQF 0059 PQRI 2 ...... Title: Diabetes Mellitus: Low Density Lipoprotein (LDL–C) Control in Diabetes Mellitus. NQF 0064

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TABLE 7—MEASURE GROUP: ENDOCRINOLOGY—Continued

Measure No. Clinical quality measure title

PQRI 3 ...... Title: Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus. NQF 0061 PQRI 117 ...... Title: Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient. NQF 0055 PQRI 119 ...... Title: Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic NQF 0062 Patients. PQRI 128 ...... Title: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up. NQF 0421 PQRI 204 ...... Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic. NQF 0068 NQF 0060 ...... Title: Hemoglobin A1c test for pediatric patients. Not applicable ...... Title: Comprehensive Diabetes Care: HbA1c Control (< 8.0 percent).

TABLE 8—MEASURE GROUP: ONCOLOGY

Measure No. Clinical quality measure title & description

PQRI 71 ...... Title: Breast Cancer: Hormonal Therapy for Stage IC–IIIC Estrogen Receptor/Progesterone Receptor (ER/ NQF 0387 PR) Positive Breast Cancer. PQRI 72 ...... Title: Colon Cancer: Chemotherapy for Stage III Colon Cancer Patients. NQF 0385 PQRI 102 ...... Title: Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low-Risk Prostate Cancer Pa- NQF 0389 tients. PQRI 112 ...... Title: Preventive Care and Screening: Screening Mammography. NQF 0031 PQRI 113 ...... Title: Preventive Care and Screening: Colorectal Cancer Screening. NQF 0034 NQF 0032 ...... Title: Cervical Cancer Screening.

TABLE 9—MEASURE GROUP: PROCEDURALIST/SURGERY

Measure No. Clinical quality measure title & description

PQRI 20 ...... Title: Perioperative Care: Timing of Antibiotic Prophylaxis—Ordering Physician. NQF 0270 PQRI 21 ...... Title: Perioperative Care: Selection of Prophylactic Antibiotic—First OR Second Generation Cephalosporin. NQF 0268 PQRI 22 ...... Title: Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures). NQF 0271 PQRI 23 ...... Title: Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients). NQF 0239 NQF 0299 ...... Title: Surgical Site Infection Rate. Not Applicable ...... Title: 30 day Readmission Rate.

TABLE 10—MEASURE GROUP: PRIMARY CARE

Measure No. Clinical quality measure title & description

PQRI 114 ...... Title: Preventive Care and Screening: Inquiry Regarding Tobacco Use. NQF 0028 PQRI 115 ...... Title: Preventive Care and Screening: Advising Smokers to Quit. NQF 0027 PQRI 202 ...... Title: Ischemic Vascular Disease (IVD): Complete Lipid Profile. NQF 0075 PQRI 203 ...... Title: Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL–C) Control. NQF 0075 PQRI 204 ...... Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic. NQF 0068 NQF 0038 ...... Title: Childhood Immunization Status. PQRI 112 ...... Title: Preventive Care and Screening: Screening Mammography. NQF 0031 PQRI 113 ...... Title: Preventive Care and Screening: Colorectal Cancer Screening. NQF 0034 PQRI 1 ...... Title: Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus. NQF 0059 NQF 0052 ...... Title: Low back pain: use of imaging studies. NQF 0018 ...... Title: Controlling High Blood Pressure. PQRI 128 ...... Title: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up. NQF 0421

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TABLE 10—MEASURE GROUP: PRIMARY CARE—Continued

Measure No. Clinical quality measure title & description

PQRI 65 ...... Title: Treatment for Children with Upper Respiratory Infection (URI): Avoidance of Inappropriate Use. NQF 0069 PQRI 66 ...... Title: Appropriate Testing for Children with Pharyngitis. NQF 0002 PQRI 110 ...... Title: Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old. NQF 0041 PQRI 197 ...... Title: Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol. NQF 0074 NQF 0001 ...... Title: Asthma Assessment NQF 0004 ...... Title: Initiation and Engagement of Alcohol and Other Drug Dependence Treatment: (a) Initiation, (b) Engagement. NQF 0024 ...... Title: Body Mass Index (BMI) 2 through 18 years of age. NQF 0032 ...... Title: Cervical Cancer Screening. NQF 0036 ...... Title: Use of appropriate medications for people with asthma. NQF 0060 ...... Title: Hemoglobin A1c test for pediatric patients. NQF 0105 ...... Title: New Episode of Depression: (a) Optimal Practitioner Contacts for Medication Management. (b) Effective Acute Phase Treatment. (c) Effective Continuation Phase Treatment. NQF 0106 ...... Title: Diagnosis of attention deficit hyperactivity disorder (ADHD) in primary care for school age children and adolescents. NQF 0107 ...... Title: Management of attention deficit hyperactivity disorder (ADHD) in primary care for school age children and adolescents. NQF 0108 ...... Title: ADHD: Follow-Up Care for Children Prescribed Attention-Deficit/Hyperactivity Disorder (ADHD) Medi- cation. NQF 0110 ...... Title: Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use. Not applicable ...... Title: Comprehensive Diabetes Care: HbA1c Control (< 8.0 percent). Not applicable ...... Title: Appropriate antibiotic use for ear infections.

TABLE 11—MEASURE GROUP: PEDIATRICS

Measure No. Clinical quality measure title & description

PQRI 66 ...... Title: Appropriate Testing for Children with Pharyngitis. NQF 0002 NQF 0060 ...... Title: Hemoglobin A1c test for pediatric patients. NQF 0106 ...... Title: Diagnosis of attention deficit hyperactivity disorder (ADHD) in primary care for school age children and adolescents. NQF 0107 ...... Title: Management of attention deficit hyperactivity disorder (ADHD) in primary care for school age children and adolescents. NQF 0108 ...... Title: ADHD: Follow-Up Care for Children Prescribed Attention-Deficit/Hyperactivity Disorder (ADHD) Medi- cation. NQF 0024 ...... Title: Body Mass Index (BMI) 2 through 18 years of age. NQF 0026 ...... Title: Measure pair— a. Tobacco use prevention for infants, children and adolescents, b. Tobacco use cessation for infants, children and adolescents. NQF 0038 ...... Title: Childhood Immunization Status. Not applicable ...... Title: Appropriate antibiotic use for ear infections.

TABLE 12—MEASURE GROUP: OBSTETRICS AND GYNECOLOGY

Measure No. Clinical quality measure title & description

PQRI 112 ...... Title: Preventive Care and Screening: Screening Mammography. NQF 0031 PQRI 128 ...... Title: Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up. NQF 0421 NQF 0032 ...... Title: Cervical Cancer Screening. NQF 0033 ...... Title: Chlamydia screening in women. NQF 0471 ...... Title: Cesarean Rate for low-risk first birth women (aka NTSV CS rate). NQF 0012 ...... Title: Prenatal Screening for Human Immunodeficiency Virus (HIV). NQF 0014 ...... Title: Prenatal Anti-D Immune Globulin. Not applicable ...... Title: Hysterectomy rates. Not applicable ...... Title: 30 Readmission Rate following deliveries.

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TABLE 13—MEASURE GROUP: NEUROLOGY

Measure No. Clinical quality measure title & description

PQRI 33 ...... Title: Stroke and Stroke Rehabilitation: Anticoagulant Therapy Prescribed for Atrial Fibrillation at Discharge. NQF 0241 PQRI 201 ...... Title: Ischemic Vascular Disease (IVD): Blood Pressure Management Control. NQF 0073 PQRI 202 ...... Title: Ischemic Vascular Disease (IVD): Complete Lipid Profile. NQF 0075 PQRI 203 ...... Title: Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL–C) Control. NQF 0075 PQRI 204 ...... Title: Ischemic Vascular Disease (IVD): Use of Aspirin or Another Antithrombotic. NQF 0068

TABLE 14—MEASURE GROUP: PSYCHIATRY

Measure No. Clinical quality measure title & description

PQRI 9 ...... Title: Major Depressive Disorder (MDD): Antidepressant Medication During Acute Phase for Patients with NQF 0105 MDD. PQRI 106 ...... Title: Major Depressive Disorder (MDD): Diagnostic Evaluation. NQF 0103 PQRI 107 ...... Title: Major Depressive Disorder (MDD): Suicide Risk Assessment. NQF 0104 NQF 0004 ...... Title: Initiation and Engagement of Alcohol and Other Drug Dependence Treatment: (a) Initiation, (b) En- gagement. NQF 0105 ...... Title: New Episode of Depression: (a) Optimal Practitioner Contacts for Medication Management, (b) Effec- tive Acute Phase Treatment, (c) Effective Continuation Phase Treatment. NQF 0110 ...... Title: Bipolar Disorder and Major Depression: Appraisal for alcohol or chemical substance use.

TABLE 15—MEASURE GROUP: OPHTHALMOLOGY

Measure No. Clinical quality measure title & description

PQRI 12 ...... Title: Primary Open Angle Glaucoma (POAG): Optic Nerve Evaluation. NQF 0086 PQRI 18 ...... Title: Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Sever- NQF 0088 ity of Retinopathy. PQRI 19 ...... Title: Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care. NQF 0089

TABLE 16—MEASURE GROUP: PODIATRY

Measure No. Clinical quality measure title & description

PQRI 127 ...... Title: Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention—Evaluation of Footwear. NQF 0416 PQRI 163 ...... Title: Diabetes Mellitus: Foot Exam. NQF 0056 NQF 0519 ...... Title: Diabetic Foot Care and Patient Education Implemented.

TABLE 17—MEASURE GROUP: RADIOLOGY

Measure No. Clinical quality measure title & description

PQRI 10 ...... Title: Stroke and Stroke Rehabilitation: Computed Tomography (CT) or Magnetic Resonance Imaging NQF 0246 (MRI) Reports. PQRI 195 ...... Title: Stenosis Measurement in Carotid Imaging Studies. NQF 0507 PQRI 145 ...... Title: Radiology: Exposure Time Reported for Procedures Using Fluoroscopy. NQF 0510 PQRI 146 ...... Title: Radiology: Inappropriate Use of ‘‘Probably Benign’’ Assessment Category in Mammography Screen- NQF 0508 ing. PQRI 147 ...... Title: Nuclear Medicine: Correlation with Existing Imaging Studies for All Patients Undergoing Bone Scintig- NQF 0511 raphy. NQF 0052 ...... Title: Low back pain: use of imaging studies. NQF 0513 ...... Title: Use of Contrast: Thorax CT.

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TABLE 18—MEASURE GROUP: GASTROENTEROLOGY

Measure No. Clinical quality measure title & description

PQRI 86 ...... Title: Hepatitis C: Antiviral Treatment Prescribed. NQF 0397 PQRI 89 ...... Title: Hepatitis C: Counseling Regarding Risk of Alcohol Consumption. NQF 0401 PQRI 113 ...... Title: Preventive Care and Screening: Colorectal Cancer Screening. NQF 0034 PQRI 183 ...... Title: Hepatitis C: Hepatitis A Vaccination in Patients with HCV. NQF 0399 PQRI 184 ...... Title: Hepatitis C: Hepatitis B Vaccination in Patients with HCV. NQF 0400 PQRI 185 ...... Title: Endoscopy & Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous AQA adopted Polyps—Avoidance of Inappropriate Use.

TABLE 19—MEASURE GROUP: NEPHROLOGY

Measure No. Clinical quality measure title & description

PQRI 81 ...... Title: End Stage Renal Disease (ESRD): Plan of Care for Inadequate Hemodialysis in ESRD Patients. NQF 0323 PQRI 82 ...... Title: End Stage Renal Disease (ESRD): Plan of Care for Inadequate Peritoneal Dialysis. NQF 0321 PQRI 121 ...... Title: Chronic Kidney Disease (CKD): Laboratory Testing (Calcium, Phosphorus, Intact Parathyroid Hor- AQA adopted mone (iPTH) and Lipid Profile). PQRI 122 ...... Title: Chronic Kidney Disease (CKD): Blood Pressure Management. AQA adopted PQRI 123 ...... Title: Chronic Kidney Disease (CKD): Plan of Care—Elevated Hemoglobin for Patients Receiving AQA adopted Erythropoiesis-Stimulating Agents (ESA). PQRI 153 ...... Title: Chronic Kidney Disease (CKD): Referral for Arteriovenous (AV) Fistula. AQA adopted

With the inclusion of measures We further propose that starting in identified in Table 20 starting in the applicable to targeting children and payment year 2012, in addition to 2011 payment year. We further propose adolescents and the wide applicability meeting requirements for measures on that for the 2012 payment year, of the measures like Blood Pressure meaningful EHR use and other hospitals will be required to submit Management, we believe this core set of requirements, EPs would be required to these measures to CMS electronically clinical quality measures and specialty electronically submit this quality using certified EHR technology on a set measures is broad enough to enable reporting information directly to CMS of clinical quality measures identified in reporting by all EPs. However, if the and States using certified EHR Table 20, which would be sufficient to public believes that other EPs would not technology. We encourage comments on meet the requirements for both the have sufficient patients in the these reporting criteria, particularly on Medicare and the Medicaid EHR denominator of these core measures, we the requirement that all EPs–would incentive (for hospitals eligible for both encourage commenters to identify the report on the set of ‘‘core measures.’’ We incentive programs), with respect to the EPs in question and propose specific are also interested in comments as to requirement to report clinical quality remedies. whether some Medicare or Medicaid measures. For hospitals eligible for only EPs may not be able to meet the the Medicaid EHR incentive program, Although we do not propose to proposed reporting requirements, why such reporting will be to States. For require clinical quality measure that might be the case, and whether eligible hospitals to which the measures reporting electronically until 2012, we commenters believe other alternative in Table 20 do not apply to their patient propose to begin clinical quality options are preferable. population, hospitals have the option to reporting through attestation in the 2011 select clinical quality measures f. Proposed Clinical Quality Measures payment year. We solicit comment on identified in Table 21 to meet the for Electronic Submission by Eligible whether it may be more appropriate to requirements for the reporting of Hospitals defer some or all clinical quality clinical quality measures for the reporting until the 2012 payment year. Based on the considerations for Medicaid program incentive. Tables 20 If reporting on some but not all clinical quality measures previously and 21, convey the clinical quality measures in 2011 is feasible, we solicit discussed in this proposed rule, we measure’s title, number, owner/ comment on which key measures propose that eligible hospitals will be developer and contact information, and should be chosen for 2011 and which required to report summary data to CMS a link to existing electronic should be deferred until 2012 and why. on the set of clinical quality measures specifications where applicable.

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TABLE 20—PROPOSED CLINICAL QUALITY MEASURES FOR ELECTRONIC SUBMISSION BY ELIGIBLE HOSPITALS FOR PAYMENT YEAR 2011–2012

Electronic measure Measure No. identifier Measure title, description & measure developer specifications information

ED–1 ...... Title: Emergency Department Throughput—admitted patients. Median time from ED http://www.hitsp.org/ arrival to ED departure for admitted patients. ConstructSet_Details. aspx?&PrefixAlpha=5& PrefixNumeric=906. NQF 0495 ...... Description: Median time from emergency department arrival to time of departure from the emergency room for patients admitted to the facility from the emergency department. Measure Developer: CMS/Oklahoma Foundation for Medical Quality (OFMQC). ED–2 ...... Title: Emergency Department Throughput—admitted patients. Admission decision http://www.hitsp.org/ time to ED departure time for admitted patients. ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0497 ...... Description: Median time from admit decision time to time of departure from the emergency department of emergency department patients admitted to inpatient status. Measure Developer: CMS/OFMQ. ED–3 ...... Title: Emergency Department Throughput—discharged patients. Median Time from ED Arrival to ED Departure for Discharged ED Patients. NQF 0496 ...... Description: Median Time from ED arrival to time of departure from the ED for pa- tients discharged from the ED. Measure Developer: CMS/OFMQ. Stroke-2 ...... Title: Ischemic stroke—Discharge on anti-thrombotics ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0435 ...... Description: Ischemic stroke patients prescribed antithrombotic therapy at hospital discharge. Measure Developer: The Joint Commission. Stroke-3 ...... Title: Ischemic stroke—Anticoagulation for A-fib/flutter ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0436 ...... Description: Ischemic stroke patients with atrial fibrillation/flutter who are prescribed anticoagulation therapy at hospital discharge. Measure Developer: The Joint Commission. Stroke-4 ...... Title: Ischemic stroke—Thrombolytic therapy for patients arriving within 2 hours of http://www.hitsp.org/ symptom onset. ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0437 ...... Description: Acute ischemic stroke patients who arrive at this hospital within 2 hours of time last known well and for whom IV t-PA was initiated at this hospital within 3 hours of time last known well. Measure Developer: The Joint Commission. Stroke-5 ...... Title: Ischemic or hemorrhagic stroke—Antithrombotic therapy by day 2 ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0438 ...... Description: Ischemic stroke patients administered antithrombotic therapy by the end of hospital day 2. Measure Developer: The Joint Commission. Stroke-6 ...... Title: Ischemic stroke—Discharge on statins ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0439 ...... Description: Ischemic stroke patients with LDL > 100 mg/dL, or LDL not measured, or, who were on a lipid-lowering medication prior to hospital arrival are pre- scribed statin medication at hospital discharge. Measure Developer: The Joint Commission. Stroke-8 ...... Title: Ischemic or hemorrhagic stroke—Stroke education ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906.

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TABLE 20—PROPOSED CLINICAL QUALITY MEASURES FOR ELECTRONIC SUBMISSION BY ELIGIBLE HOSPITALS FOR PAYMENT YEAR 2011–2012—Continued

Electronic measure Measure No. identifier Measure title, description & measure developer specifications information

NQF 0440 ...... Description: Ischemic or hemorrhagic stroke patients or their caregivers who were given educational materials during the hospital stay addressing all of the fol- lowing: activation of emergency medical system, need for follow-up after dis- charge, medications prescribed at discharge, risk factors for stroke, and warning signs and symptoms of stroke. Measure Developer: The Joint Commission. Stroke-10 ...... Title: Ischemic or hemorrhagic stroke—Rehabilitation assessment ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0441 ...... Description: Ischemic or hemorrhagic stroke patients who were assessed for reha- bilitation services. Measure Developer: The Joint Commission. VTE–1 ...... Title: VTE prophylaxis within 24 hours of arrival ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0371 ...... Description: This measure assesses the number of patients who received VTE pro- phylaxis or have documentation why no VTE prophylaxis was given the day of or the day after hospital admission or surgery end date for surgeries that start the day of or the day after hospital admission. Measure Developer: The Joint Commission. VTE–2 ...... Title: ICU VTE prophylaxis ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0372 ...... Description: This measure assesses the number of patients who received VTE pro- phylaxis or have documentation why no VTE prophylaxis was given the day of or the day after the initial admission (or transfer) to the Intensive Care Unit (ICU) or surgery end date for surgeries that start the day of or the day after ICU admis- sion (or transfer). Measure Developer: The Joint Commission. VTE–3 ...... Title: Anticoagulation overlap therapy ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0373 ...... Description: This measure assesses the number of patients diagnosed with con- firmed VTE who received an overlap of parenteral (intravenous [IV] or subcuta- neous [subcu]) anticoagulation and warfarin therapy. For patients who received less than five days of overlap therapy, they must be discharged on both medica- tions. Overlap therapy must be administered for at least five days with an inter- national normalized ratio (INR) ≥ 2 prior to discontinuation of the parenteral anticoagulation therapy or the patient must be discharged on both medications. Measure Developer: The Joint Commission. VTE–4 ...... Title: Platelet monitoring on unfractionated heparin ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0374 ...... Description: This measure assesses the number of patients diagnosed with con- firmed VTE who received intravenous (IV) UFH therapy dosages AND had their platelet counts monitored using defined parameters such as a nomogram or pro- tocol. Measure Developer: The Joint Commission. VTE–5 ...... Title: VTE discharge instructions ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0375 ...... Description: This measure assesses the number of patients diagnosed with con- firmed VTE that are discharged to home, to home with home health, home hos- pice or discharged/transferred to court/law enforcement on warfarin with written discharge instructions that address all four criteria: compliance issues, dietary ad- vice, follow-up monitoring, and information about the potential for adverse drug reactions/interactions.

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TABLE 20—PROPOSED CLINICAL QUALITY MEASURES FOR ELECTRONIC SUBMISSION BY ELIGIBLE HOSPITALS FOR PAYMENT YEAR 2011–2012—Continued

Electronic measure Measure No. identifier Measure title, description & measure developer specifications information

Measure Developer: The Joint Commission. VTE–6 ...... Title: Incidence of potentially preventable VTE ...... http://www.hitsp.org/ ConstructSet_Details. aspx?&Prefix Alpha=5&Prefix Numeric=906. NQF 0376 ...... Description: This measure assesses the number of patients diagnosed with con- firmed VTE during hospitalization (not present on arrival) who did not receive VTE prophylaxis between hospital admission and the day before the VTE diag- nostic testing order date. Measure Developer: The Joint Commission. RHQDAPU AMI–8a ...... Title: Primary PCI Received Within 90 Minutes of Hospital Arrival. NQF 0163 ...... Description: Acute myocardial infarction (AMI) patients with ST-segment elevation or LBBB on the ECG closest to arrival time receiving primary PCI during the hos- pital stay with a time from hospital arrival to PCI of 90 minutes or less. Measure Developer: CMS/OFMQ. RHQDAPU PN–3b ...... Title: Blood Cultures Performed in the Emergency Department Prior to Initial Anti- biotic Received in Hospital. NQF 0148 ...... Description: Pneumonia patients whose initial emergency room blood culture speci- men was collected prior to first hospital dose of antibiotics. This measure focuses on the treatment provided to Emergency Department patients prior to admission orders. Measure Developer: CMS/OFMQ. RHQDAPU AMI–2 ...... Title: Aspirin Prescribed at Discharge. NQF 0142 ...... Description: Acute myocardial infarction (AMI) patients who are prescribed aspirin at hospital discharge. Measure Developer: CMS/OFMQ. RHQDAPU AMI–3...... Title: Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) for Left Ventricular Systolic Dysfunction (LVSD). NQF 0137 ...... Description: Acute myocardial infarction (AMI) patients with left ventricular systolic dysfunction (LVSD) who are prescribed an ACEI or ARB at hospital discharge. For purposes of this measure, LVSD is defined as chart documentation of a left ventricular ejection fraction (LVEF) less than 40% or a narrative description of left ventricular systolic (LVS) function consistent with moderate or severe systolic dysfunction. Measure Developer: CMS/OFMQ. RHQDAPU AMI–5 ...... Title: Beta-Blocker Prescribed at Discharge. NQF 0160 ...... Description: Acute myocardial infarction (AMI) patients who are prescribed a betablocker at hospital discharge. Measure Developer: CMS/OFMQ. RHQDAPU AMI–READ ...... Title & Description: Hospital Specific 30 day Risk-Standardized Readmission Rate following AMI admission. NQF 0505 ...... Measure Developer: CMS. Not applicable ...... Title: Hospital Specific 30 day Rate following AMI admission. RHQDAPU HF–READ ...... Title & Description: Hospital Specific 30 day Risk-Standardized Readmission Rate following Heart Failure admission. NQF 0330 ...... Measure Developer: CMS/OFMQ. Not applicable ...... Title: Hospital Specific 30 day Rate following Heart Failure admission. RHQDAPU PNE–READ ...... Title & Description: Hospital Specific 30 day Risk-Standardized Readmission Rate following Pneumonia admission. NQF 0506 ...... Measure Developer: CMS. Not applicable ...... Title: Hospital Specific 30 day Rate following Pneumonia admission. NQF 0528 ...... Title: Infection SCIP Inf-2 Prophylactic antibiotics consistent with current rec- ommendations. Description: Surgical patients who received prophylactic antibiotics consistent with current guidelines (specific to each type of surgical procedure). Measure Developer: CMS/OFMQ. NQF 0302 ...... Title: Ventilator Bundle. Description: Percentage of intensive care unit patients on mechanical ventilation at time of survey for whom all four elements of the ventilator bundle are docu- mented and in place. The ventilator bundle elements are: • Head of bed (HOB) elevation 30 degrees or greater (unless medically con- traindicated); noted on 2 different shifts within a 24 hour period.

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TABLE 20—PROPOSED CLINICAL QUALITY MEASURES FOR ELECTRONIC SUBMISSION BY ELIGIBLE HOSPITALS FOR PAYMENT YEAR 2011–2012—Continued

Electronic measure Measure No. identifier Measure title, description & measure developer specifications information

• Daily ‘‘sedation interruption’’ and daily assessment of readiness to extubate; process includes interrupting sedation until patient follow commands and pa- tient is assessed for discontinuation of mechanical ventilation; Parameters of discontinuation include: resolution of reason for intubation; inspired oxygen content roughly 40%; assessment of patients ability to defend airway after extubation due to heavy sedation; minute ventilation less than equal to 15 li- ters/minute; and respiratory rate/tidal volume less than or equal to 105/min/L (RR/TV < 105). • SUD (peptic ulcer disease) prophylaxis DVT (deep venous thrombosis) pro- phylaxis. Measure Developer: IHI. NQF 0298 ...... Title: Central Line Bundle Compliance. Description: Percentage of intensive care patients with central lines for whom all elements of the central line bundle are documented and in place. The central line bundle elements include: • Hand hygiene. • Maximal barrier precautions upon insertion. • Chlorhexidine skin antisepsis. • Optimal catheter site selection, with subclavian vein as the preferred site for non-tunneled catheters in patients 18 years and older. • Daily review of line necessity with prompt removal of unnecessary lines. Measure Developer: IHI. NQF 0140 ...... Title: Ventilator-associated pneumonia for ICU and high-risk nursery (HRN) pa- tients. Description: Percentage of ICU and HRN patients who over a certain amount of days have ventilator-associated pneumonia. Measure Developer: CDC. NQF 0138 ...... Title: Urinary catheter-associated urinary tract infection for intensive care unit (ICU) patients. Description: Percentage of intensive care unit patients with urinary catheter-associ- ated urinary tract infections. Measure Developer: CDC. NQF 0139 ...... Title: Central line catheter-associated blood stream infection rate for ICU and high- risk nursery (HRN) patients. Description: Percentage of ICU and high-risk nursery patients, who over a certain amount of days acquired a central line catheter-associated blood stream infec- tions over a specified amount of line-days. Measure Developer: CDC. NQF 0329 ...... Title: All-Cause Readmission Index (risk adjusted). Description: Overall inpatient 30-day hospital readmission rate. Measure Developer: United Health Group. Not applicable ...... Title: All-Cause Readmission Index. Description: Overall inpatient 30-day hospital readmission rate.

TABLE 21—PROPOSED ALTERNATIVE MEDICAID CLINICAL QUALITY MEASURES FOR MEDICAID ELIGIBLE HOSPITALS

Electronic measure NQF No. Measure title, description & measure developer specifications information

0341 ...... Title: PICU Pain Assessment on Admission. Description: Percentage of PICU patients receiving: a. Pain assessment on admission. b. Periodic pain assessment. Measure Developer: Vermont Oxford Network. 0348 ...... Title: Iotrogenic pneumothorax in non-neonates (pediatric up to 17 years of age). Description: Percent of medical and surgical discharges, age under 18 years, with ICD–9–CM code of iatrogenic pneumothorax in any secondary diagnosis field. Measure Developer: AHRQ. 0362 ...... Title: Foreign body left after procedure, age under 18 years. Description: Discharges with foreign body accidentally left in during procedure per 1,000 discharges. Measure Developer: AHRQ. 0151 ...... Title: Pneumonia Care PNE–5c Antibiotic. Description: Percentage of pneumonia patients 18 years of age and older who re- ceive their first dose of antibiotics within 6 hours after arrival at the hospital. Measure Developer: CMS/OFMQ. 0147 ...... Title: Pneumonia Care PN–6 Antibiotic selection. Description: Percentage of pneumonia patients 18 years of age or older selected for initial receipts of antibiotics for community-acquired pneumonia (CAP).

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TABLE 21—PROPOSED ALTERNATIVE MEDICAID CLINICAL QUALITY MEASURES FOR MEDICAID ELIGIBLE HOSPITALS— Continued

Electronic measure NQF No. Measure title, description & measure developer specifications information

Measure Developer: CMS/OFMQ. 0356 ...... Title: Pneumonia Care PN–3a Blood culture. Description: Percent of pneumonia patients, age 18 years or older, transferred or admitted to the ICU within 24 hours of hospital arrival who had blood cultures performed within 24 hours prior to or 24 hours after arrival at the hospital. Measure Developer: CMS/OFMQ. 0527 ...... Title: Infection SCIP Inf-1 Prophylactic antibiotic received within 1 hour prior to sur- gical incision. Description: Surgical patients with prophylactic antibiotics initiated within 1 hour prior to surgical incision. Patients who received vancomycin or a fluoroquinolone for prophylactic antibiotics should have the antibiotics initiated within 2 hours prior to surgical incision. Due to the longer infusion time required for vancomycin or a fluoroquinolone, it is acceptable to start these antibiotics within 2 hours prior to incision time. Measure Developer: CMS/OFMQ. 0529 ...... Title: Infection SCIP Inf-3 Prophylactic antibiotics discontinued within 24 hours after surgery end time. Description: Surgical patients whose prophylactic antibiotics were discontinued within 24 hours after Anesthesia End Time. Measure Developer: CMS/OFMQ.

We have included in the hospital Therapy. We note that Atrial Fibrillation measure applies, regardless of payer, measures set several clinical quality Receiving Anticoagulation Therapy is discharged from the hospital during the measures which have undergone one of the clinical quality measures EHR reporting period and for whom the development of electronic included on Table 20, identified in the clinical quality measure is applicable. specifications. These clinical quality table as Stroke-3. We note that we have Although we do not propose to require measures have been developed for not included the HIT Standards clinical quality reporting electronically future RHQDAPU consideration. The Committee recommended clinical until 2012, we propose to begin clinical electronic specifications were quality measure on surgery patients who quality reporting though attestation in developed through an interagency received VTE prophylaxis within 24 the 2011 payment year. We solicit agreement with ONC to develop hours period to surgery to 24 hours after comment on whether it may be more interoperable standards for EHR surgery end time because it is a current appropriate to defer some or all clinical submission of the ED throughput, clinical quality measure collected in the quality reporting until the 2012 stroke, and VTE clinical quality RHQDAPU program through chart payment year. If reporting on some but measures on Table 20, to be determined abstraction for all applicable patients not all measures in 2011 is feasible, we by a future rulemaking document (SCIP–VTE–2). The VTE–2 clinical solicit comment on which key measures provided by ONC. We also have quality measure in Table 20 is a parallel should be chosen for 2011 and which planned to test the submission of these clinical quality measure to SCIP–VTE– should be deferred until 2012 and why. clinical quality measures in Medicare 2, includes non-surgical patients, and is We invite comments on these (see 74 FR 43893). The specifications for a more feasible to implement because proposed clinical quality measures for the RHQDAPU clinical quality measures the electronic specifications have been eligible hospitals and our proposed for eligible hospitals that are being used completed. We have however added timelines to post specification for testing EHR-based submission of SCIP–VTE–2 for future consideration. documents for these clinical quality these clinical quality measures can be To satisfy the requirements of measures to the CMS Web site. found at http://www.hitsp.org/ reporting on clinical quality measures _ g. Request for Public Comment on ConstructSet Details.aspx?& under sections 1886(n)(3)(A)(iii) and Potential Measures for EPs and Eligible PrefixAlpha=5&PrefixNumeric=906. A 1903(t)(6)(C) of the Act for the 2011– Hospitals in 2013 Payment Year and description of the clinical quality 2012 payment year, we propose to Subsequent Years measure, including the clinical quality require eligible hospitals to report on all measure’s numerator and denominator, EHR incentive clinical quality measures We expect that the number of clinical can be found here as well. Other for which they have applicable cases, quality measures for which EPs and measures are currently in the without regard to payer. Medicare eligible hospitals will be able to RHQDAPU program or are measures of eligible hospitals, who are also electronically submit information will importance for measuring or preventing participating in the Medicaid EHR rapidly expand in 2013 and beyond. adverse outcomes. In addition to Risk incentive program, will also be required We plan to consider measures from Standardized readmission clinical to report on all Medicaid clinical quality the 2010 PQRI program. These clinical quality measures, we have proposed measures for which the eligible hospital quality measures can be found at Readmission rates to be reported which has applicable cases. To demonstrate http://www.cms.hhs.gov/PQRI/05_ are not risk adjusted. We have also that it is an eligible meaningful EHR StatuteRegulationsProgramInstructions. reviewed the recommendations of the user, the eligible hospital is required to asp HIT Standards Committee that apply to electronically submit information on For future considerations of clinical hospitals which include Atrial each clinical quality measures for each quality measures for 2013 and beyond Fibrillation Receiving Anticoagulation patient to whom the clinical quality for eligible hospitals, we will also

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consider other clinical quality measures of the numerators, denominators, and • The identifying information for the from the RHQDAPU program which are exclusions submitted for each of the eligible hospital. identified in the FY 2010 IPPS final rule applicable measures, and report the • For eligible hospitals that do not (74 FR 43868 through 43882). We invite results to CMS for all applicable report one or more measures an comments on inclusion of clinical patients. attestation that the clinical quality quality measures for the 2013 and Attestation will utilize the same measures not reported do not apply to beyond HITECH Act Medicare and system for other attestation for any patients treated by the eligible Medicaid incentive program, based on meaningful use, and we propose to hospital during the reporting period. • Stage 2 and Stage 3 meaningful use require for Medicare EPs that they attest The numerators, denominators, and criteria. to the following: exclusions for each clinical quality For the 2013 payment year, we are • The information submitted with measure result reported, providing considering expanding the Medicaid respect to clinical quality measures was separate information for each clinical EHR incentive programs clinical quality generated as output of an identified quality measure including the measure set for EPs and eligible certified electronic health record. numerators, denominators, and hospitals to include clinical quality • The information submitted is exclusions for all patients irrespective measures that address the following accurate to the best of the knowledge third party payer or lack thereof; for clinical areas, to address quality of care and belief of the EP. Medicare FFS patients; for Medicare for additional patient populations, and • The information submitted includes Advantage patients; and for Medicaid facilitate alignment with Medicaid and information on all patients to whom the patients. • The beginning and end dates for CHIP programs: clinical quality measure applies. which the numerators, denominators, • Additional pediatrics measures • The NPI and TIN of the EP and exclusions apply. (such as completed growth charts, submitting the information, and the electronic prescriptions with weight- specialty group of clinical quality (2) Reporting Method for 2012 based dosing support and measures that are being submitted. In accordance with sections documentation of newborn screening). • For an EP who is exempt from • 1848(o)(2)(A)(iii) and 1886(n)(3)(A)(iii) Long-term care measures. reporting each of the core measures, an of the Act, an EP or eligible hospital, • Additional obstetrics measure. attestation that one or more of the core respectively, must submit summary • Dental care/oral health measures. measures do not apply to the scope of information (that is, information that is • Additional mental health and practice of the EP. not personally identifiable) on the substance abuse measures. • For an EP who is exempt from clinical quality measures selected by the The above lists do not constitute a reporting on a specialty group, an Secretary using certified EHR comprehensive list of all clinical quality attestation that none of the specialty technology in order to demonstrate their measures that may be considered. groups applies to the scope of practice meaningful use of certified EHR Specific measures for payment years of the EP. technology. Additionally, for the 2012 2013 and beyond will be addressed by • For an EP who does report on a payment year, we propose that EPs and CMS in future notice and comment specialty group, but is exempt from eligible hospitals be required to rulemaking. To assist us in identifying reporting on each of the clinical quality electronically submit the summary potential clinical quality measures for measures in the group, an attestation information for a selected clinical future consideration for years 2013 and that the clinical quality measures not quality measure from those listed in beyond, we welcome comments on the reported do not apply to any patients Tables 3 through 21 using certified EHR potential topics and/or clinical quality treated by the EP. technology as defined in section II.A.1.a measures listed above as well as • The numerators, denominators, and of this proposed rule for the Medicare suggestions for additional clinical exclusions for each clinical quality and Medicaid incentives. The required quality measure topics and/or specific measure result reported, providing Medicare incentive information will be clinical quality measures. separate information for each clinical identified in the measures h. Proposed Reporting Method for quality measure including the specifications, which we intend will be Clinical Quality Measures for 2011 and numerators, denominators, and on our Web site 9 months before the 2012 Payment Year exclusions for all patients irrespective start of the payment year. For Medicaid, third party payer or lack thereof; for EPs and hospitals eligible only for the (1) Reporting Method for 2011 Payment Medicare FFS patients; for Medicare Medicaid EHR incentive program must Year Advantage patients; and for Medicaid report their clinical quality measures As we previously discussed, we patients. data to States. States will propose to propose to use attestation as a means for • The beginning and end dates for CMS how they plan to accept and EPs and eligible hospitals, for purposes which the numerators, denominators, validate Medicaid providers’ clinical of the Medicare incentive program, to and exclusions apply. quality measures data in their State demonstrate the meaningful use For eligible hospitals, we propose to Medicaid HIT Plans, subject to CMS requirement for the calculation and require that they attest to the following: review and approval, as described in submission of clinical quality measure • The information submitted with section II.D.7. of this proposed rule. results to CMS. respect to clinical quality measures was Sections 1848(o)(A)(2)(iii) and Specifically, for 2011, we propose to generated as output from an identified 1886(n)(3)(A)(iii) of the Act broadly require that Medicare EPs and hospitals certified EHR. state that as a condition of attest to the use of a certified EHR • The information submitted to the demonstrating meaningful use of system to capture the data elements and knowledge and belief of the official certified EHR technology, an EP, CAH or calculate the results for the applicable submitting on behalf of the eligible eligible hospital must ‘‘submit clinical quality measures. hospital. information’’ for the EHR reporting We further propose to require that • The information submitted includes period on the clinical quality or other Medicare EPs and eligible hospitals information on all patients to whom the measures selected by the Secretary ‘‘in a attest to the accuracy and completeness measure applies. form and manner specified by the

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Secretary.’’ This language does not limit measure sets for both the Medicare EHR pertain to CMS for Medicare and to us to collecting only that information Incentive Programs for EPs and the States for Medicaid. pertaining to Medicare and Medicaid PQRI, we note that there is no existing i. Alternative Reporting Methods for beneficiaries. Therefore, we believe that statutory authority to make PQRI Clinical Quality Measures we have the authority to collect incentive payments for services summarized clinical quality measures furnished in 2011 and subsequent years. There are several alternative reporting selected by the Secretary, with respect We propose that Medicare EPs and methods we considered to create a to all patients to whom the clinical eligible hospitals would be required to dataset of provider-submitted summary quality measure applies, treated by the report the required clinical quality data. One such alternative is the EP or eligible hospital. We believe that measures information electronically development of a distributed network of it is necessary for the EP or eligible using certified EHR technology via one EHRs where health information is hospital to report on all cases to which of three methods. The primary method retained locally in individual EP or a clinical quality measures applies in would require the EP or eligible hospital eligible hospital EHRs and only order to accurately assess the quality of to log into a CMS-designated portal. summary reports are submitted to CMS. care rendered by the particular EP or Once the EP or eligible hospital has Another alternative is the creation of eligible hospital generally. Otherwise it logged into the portal, they would be databases of patient-level EHR data would only be possible to evaluate the required to submit, through an upload stored at the state or regional level. We care being rendered for a portion of process, data payload based on specified invite comment on our proposed patients and lessen the ability to structures, such as Clinical Data approach, as well as our two improve quality generally. We solicit Architecture (CDA), and accompanying alternatives. We also invite comment on comments on the impact of requiring templates produced as output from their all other alternative reporting methods. the submission of clinical quality certified EHR technology. As an alternative to this data j. Proposed Reporting Criteria for EPs measures data on all patients, not just and Eligible Hospitals Medicare and Medicaid beneficiaries. submission method, we propose to permit Medicare EPs and eligible Sections 1848(o)(A)(2)(iii) and Sections 1848(o)(2)(B)(iii) and hospitals to submit the required clinical 1886(n)(3)(A)(iii) of the Act state that to 1886(n)(3)(B)(iii) of the Act requires that quality measures data using certified demonstrate meaningful use of certified in selecting clinical quality measures, EHR technology through Health EHR technology for an EHR reporting the Secretary shall seek to avoid Information Exchange (HIE)/Health period, an EP and eligible hospital must redundant or duplicative reporting Information Organization (HIO). This submit information ‘‘for such period’’ on otherwise required, including reporting alternative data submission method the clinical quality measures and other under section 1848(k)(2)(C) of the Act would be dependent on the Secretary’s measures selected by the Secretary. We (the PQRI program) and eligible ability to collect data through a HIE/HIO therefore propose that for 2011 and reporting under section network and would require the EP or 2012, the reporting period for the 1886(b)(3)(B)(viii) of the Act eligible hospital who chooses to submit clinical quality measures selected by the (RHQDAPU program). We interpret data via an HIE/HIO network to be a Secretary be the EHR reporting period as ‘‘redundant or duplicative reporting’’ to participating member of the HIE/HIO previously defined in section II.A.1.e. of mean requiring the reporting of data on network. Medicare EPs and eligible this proposed rule. the same clinical quality measure hospitals would be required to submit Another alternative we considered separately for two or more quality their data payload based on specified was a fixed reporting period of four reporting programs under Medicare. structures or profiles, such as Clinical quarterly reporting periods, or 2, 6- Similarly, we seek to align clinical Data Architecture (CDA), and month reporting periods. In terms of quality measure reporting activities accompanying templates. The EP’s or practice and precedent for other under CHIPRA with those proposed eligible hospital’s data payload should Medicare clinical quality measure here, to avoid duplication of reporting be an output from their respective reporting programs, all submit data to us and to strengthen the quality reporting certified EHR products, in the form and at specific reporting intervals. infrastructure more broadly. Therefore, manner specified from their HIE/HIO We invite industry and interested when a clinical quality measure is adopted architecture into the CMS HIE/ stakeholder comments on our proposal, included in more than one quality HIO adopted architecture. especially those who may feel that a reporting incentive program, we will As another potential alternative, we fixed period would be more seek to avoid requiring EPs and eligible propose to accept submission through advantageous. hospitals to report the same clinical registries dependent upon the k. Addressing Dually Eligible Medicare/ quality measure under separate development of the necessary capacity Medicaid Beneficiaries Under HITECH programs. In instances in which a and infrastructure to do so using particular clinical quality measure is certified EHRs. Since the EHR incentives are based on included in the Medicare EHR incentive We intend to post the technical Medicare or Medicaid EPs choosing one program and another Medicare quality requirements for portal submission and program or the other, we are concerned reporting incentive program, an EP or the alternative HIE/HIO submission, the that the Medicare and Medicaid eligible hospital would only need to HIE/HIO participating member incentive programs address the HIT report the measure under the Medicare definition, and other specifications for needs of dually eligible program EHR incentive program, and the submission on our Web site for beneficiaries. Since this population reporting of such clinical quality Medicare EPs on or before July 1, 2011 requires special coordination between measure using certified EHR technology and for Medicare eligible hospitals on or the State and Federal government, we would be considered as the EP or before April 1, 2011 for EHR adoption intend to engage in new efforts to eligible hospitals having satisfied the and incorporation and to accommodate promote Medicare health information parallel reporting requirement under all EHR vendors. exchange with States, as well as look for other applicable Medicare programs. We invite comments on our three other new ways to meet the care With respect to any clinical quality proposed clinical quality measures data management objectives of this measures that may be included in the submission methodologies as they population through HIT. As such, we

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are requesting comments on potential attestation. For payment years beginning 2012 in Medicare and Medicaid, we also measures to reach our goal. in CY and FY 2012 and subsequent propose for CMS and/or the States to years, we are proposing at § 495.8 that test options to utilize existing and 4. Demonstration of Meaningful Use EPs and eligible hospitals demonstrate emerging HIT products and Section 1848(o)(3)(C) of the Act, as that they satisfy each of the proposed infrastructure capabilities to satisfy added by section 4101(a) of the HITECH meaningful use objectives other than other objectives of the meaningful use Act, requires that as a condition of ‘‘Submitting quality measures to CMS or definition. The optional testing could eligibility for the incentive payment, an the States’’ through attestation, and involve the use of registries or the direct EP must demonstrate meaningful use of demonstrate that they satisfy the electronic reporting of some measures certified EHR technology (other than the objective ‘‘Submitting quality measure to associated with the objectives of the reporting on clinical quality and other CMS or the States’’ through electronic meaningful use definition. We do not measures) as discussed in section II.A.3 reporting of clinical quality measures to propose to require any EP or eligible of this proposed rule in the manner CMS or the States, as specified in hospital to participate in this testing in specified by the Secretary, which may section II.A.3 of this proposed rule. either 2011 or 2012 in order to receive include the following: An attestation, Specifically, we propose that EPs and an incentive payment. However, in the submission of claims with eligible hospitals provide attestation order to make progress towards our goal appropriate coding, a survey response, through a secure mechanism, such as of meaningful use being demonstrated reporting of clinical quality or other through claims based reporting or an through the electronic exchange of measures, or other means. Similarly, online portal. We propose that an EP or information we encourage States to section 1886(n)(3)(c) of the Act, as eligible hospital would through a one- explore the available options. The state added by section 4102(a) of the HITECH time attestation following the of electronic exchange varies widely Act, requires that hospitals seeking the completion of the EHR reporting period across the country and is dependent on incentive payment demonstrate for a given payment year identify the numerous Federal, State, local, non- meaningful use of certified EHR certified EHR technology they are profit and for-profit initiatives. Given technology in the manner specified by utilizing and the results of their this high state of flux, CMS and/or the the Secretary. Section 1903(t)(6)(C)(i)(II) performance on all the measures States would have to issue considerable of the Act, as added by section associated with the objectives of updated guidance to EPs and eligible 4201(a)(2) under the HITECH Act, states meaningful use. We chose to propose hospitals who wish to join in our efforts that a Medicaid EP or eligible hospital attestation through a secure mechanism to explore the electronic exchange of must demonstrate meaningful use because we do not believe that HIT will information. Any testing should be through a ‘‘means that is approved by advance enough from its current state to based on the principal of electronic the State and acceptable to the allow for more automated and/or exchange of information from certified Secretary.’’ In addition, pursuant to documented options of demonstrating EHR technology either directly to the section 1903(t)(9) of the Act, a State meaningful use. As HIT matures we States or through an intermediary. For must demonstrate to the satisfaction of expect to base demonstration more on purposes of the programs in this the Secretary that the State is automated reporting by certified EHR proposed rule it would be conducting adequate oversight, technologies, such as the direct counterproductive for an intermediary including the routine tracking of electronic reporting of measures both to collect information through paper meaningful use attestations and clinical and non clinical and abstraction. reporting mechanisms. documented participation in HIE. The We will issue further instructions on first example is to the move from the specifics for submitting attestation a. Common Methods of Demonstration attestation for clinical quality measures through established outreach venues. in Medicare and Medicaid to direct reporting in 2012 and 5. Data Collection for Online Posting, We propose to create a common subsequent years for EPs and eligible Program Coordination, and Accurate method for demonstrating meaningful hospitals. As HIT advances we expect to Payments use in both the Medicare and Medicaid move more of the objectives away from EHR incentive programs, for the same being demonstrated through attestation. As described below, the HITECH Act reasons we have proposed a uniform However, given the current state of HIT, requires the Secretary to post online the definition of meaningful use. The we believe that imposing such names of Medicare EPs and eligible demonstration methods we adopt for demonstration requirements for 2011 hospitals and CAHs who are meaningful Medicare would automatically be would pose significant barriers to EHR users for the relevant payment available to the States for use in their participation in the EHR incentive year. Section 1903(t)(2) of the Act also Medicaid programs. The Medicare programs. requires us to ensure that EPs do not methods are segmented into two parts, We believe that the means by which receive an EHR incentive payment as discussed below. States seeking to EPs and eligible hospitals demonstrate under both Medicare and Medicaid. To modify or propose alternative meaningful use should work for all fulfill these mandates, we must collect demonstration methods must submit the provider types. We also believe that several data elements from EPs and proposed methods for prior CMS uniform means of demonstration for EPs eligible hospitals. Beyond these two approval. This process is discussed and eligible hospitals are preferable and direct HITECH Act requirements, CMS more fully in Section II.D.7.b.2.c. of this that a greater burden should not be and the States also require certain data proposed rule. placed on one or the other. In addition, in order to accurately calculate and we do not believe that demonstration of distribute the incentive payments. b. Methods for Demonstration of the meaningful use should require use of Stage 1 Criteria of Meaningful Use certified EHR technology beyond the a. Online Posting We are proposing at § 495.8 that for capabilities certified to be determined Section 1848(o)(3)(D) of the Act CY 2011 and FY 2011, EPs and eligible by a future rulemaking document requires the Secretary to list in an easily hospitals demonstrate that they satisfy provided by ONC. understandable format the names, each of the proposed meaningful use In addition to requiring electronic business addresses, and business phone objectives specified in § 495.6 through reporting of clinical quality measures in numbers of the Medicare EPs and, as

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determined appropriate by the incentive programs after making the incentive payment program switch Secretary, of group practices receiving initial election. We believe this one-time would be CY 2014. In making this incentive payments for being election rule would allow an EP whose proposal, we considered that it is both meaningful EHR users under the patient volume no longer makes him or the last year an EP can enroll in the Medicare FFS program on our internet her eligible for the Medicaid program to Medicare EHR incentive program, and Web site. We do not propose to post nevertheless continue to receive also the last year before the payment information on group practices because incentive payments that would adjustments under Medicare can begin. we do not propose to base incentive encourage the meaningful use of We request comments on the necessity payments at the group practice level. certified EHR technology. For example, of the ability to switch and the allowed Section 1886(n)(4)(B) of the Act, as an EP who moves to a different practice timing for such switches. added by section 4102(c) of the HITECH or geographically relocates practices c. Data To Be Collected Act, requires the Secretary to list in an may reduce his or her Medicaid patient easily understandable format the names volume, and therefore become ineligible In addition to information regarding and other relevant data, as she for the Medicaid incentive payments. the demonstration of meaningful use, in determines appropriate, of eligible Allowing this EP to continue to receive § 495.10 of this proposed rule we hospitals and CAHs who are meaningful incentive payments under Medicare (if propose to collect the following EHR users under the Medicare FFS eligible) would continue the incentive administrative data for the Medicare program, on our internet Web site. for meaningfully using EHR technology, and Medicaid EHR incentive programs Eligible hospitals and CAHs will have and would allow EPs a certain amount to fulfill our requirements of online the opportunity to review the list before of flexibility in their operations. While posting, avoidance of duplication of the list is publicly posted. Sections allowing this flexibility creates incentive payments, and to ensure 1853(m)(5) and 1853(l)(7) of the Act, as administrative complexity, we believe a accurate and timely incentive payments: added by sections 4101(c) and 4102(c) significant number of EPs could have • Name, NPI, business address, and of the HITECH Act, require the their participation in the EHR incentive business phone of each EP or eligible Secretary to post the same information programs endangered due to changing hospital. • for EPs and eligible hospitals in the MA circumstances unrelated to the EHR Taxpayer Identification Number program as would be required if they incentive programs. (TIN) to which the EP or eligible were in the Medicare FFS program. hospital wants the incentive payment Under our proposal, if an EP does Additionally, the Secretary must post made. For Medicaid EPs this must be decide to switch programs, we propose the names of the MA organizations consistent with assignment rules at that the EP would continue in the next receiving the incentive payment or § 495.10. program at whichever payment year he payments. We propose to collect the • For EPs, whether they elect to or she would have attained had the EP information necessary to post the name, participate in the Medicare EHR not chosen to switch. For example, if an business address and business phone incentive programs or the Medicaid EP decides to switch after receiving his numbers of all EPs, eligible hospitals EHR incentive program. or her Medicare FFS incentive payment and CAHs participating in the Medicare • For eligible hospitals, their CCN. FFS and MA EHR incentive programs, for their second payment year, then the To coordinate with the States to avoid and to post this information on our Web EP would be in its third payment year duplication of payments, we further site. for purposes of the Medicaid incentive propose to make available to the States payments. Even after lining up the through a single repository the b. Program Election Between Medicare payment years, it is possible for an EP following additional data: FFS/MA and Medicaid for EPs to exceed the payment cap under • Whether an EP or eligible hospital Section 1903(t)(2) of the Act prohibits Medicaid by switching programs at the is a meaningful EHR user, and an EP from receiving incentive right time. We do not believe that the • The remittance date and amount of payments under the Medicaid program Congress intended for the payment caps any incentive payments made to an EP unless the EP has waived any rights to to be exceeded under any circumstance, or eligible hospital. incentive payments under the Medicare and therefore propose that no EP should CMS, our contractors, and the States FFS or MA programs. Furthermore, receive more than the maximum will have access to these six data section 1903(t)(7) of the Act requires the incentive available to them under elements through a single repository Secretary to assure no duplication of Medicaid, which is the higher of the two maintained by CMS. The States will funding with respect to the Medicaid caps. The last year incentive payment have to provide information to us on program, and the physician and MA would be reduced if awarding the EP whether EPs or eligible hospitals are incentive payments under sections the full amount would exceed the eligible for the Medicaid incentive 1848(o) and 1853(l) of the Act. This overall maximum available under program, whether EPs or eligible waiver and non-duplication Medicaid. This is possible if an EP hospitals participating in the Medicaid requirement applies only to EPs meeting receives their first two payment years program are meaningful EHR users, and both the Medicare FFS/MA and from Medicare and then the last four when any Medicaid incentive payments Medicaid EHR incentive programs from Medicaid, as the cap would be are made and the amount of the eligibility criteria, and does not apply to exceeded by $250. An EP who switches payment. We will put in place processes hospitals (which are eligible to receive from Medicaid to Medicare could for an EP or eligible hospital to change incentive payments from both Medicare exceed the Medicare threshold in a their information, including the one- and Medicaid simultaneously). number of circumstances; however, time switch in EHR incentive program Proposed § 495.10 would allow an EP since they cannot exceed the Medicaid election by EPs. meeting the eligibility criteria for both threshold under any circumstance, we the Medicare FFS/MA and Medicaid propose to pay the incentive for which 6. Hospital-Based Eligible Professionals programs to participate in either they are eligible for a given payment Section 1848(o)(1)(C)(i) of the Act, as program. Further, the EP would be year in whichever program they are in added by section 4101(a) of the HITECH permitted to change his or her election for that payment year. Finally, we Act, states that hospital-based EPs are once during the life of the EHR propose that the last year for making an not eligible for the Medicare incentive

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payments. Similarly, the majority of the hospital to provide medical services. campus and off-campus provider-based hospital-based EPs will not be eligible Similarly, it seems reasonable to assume departments (PBDs) of the hospital, and for Medicaid incentive payments under that the statute contemplates that an EP entities having provider-based status, as 1903(t)(2)(A) of the Act (the only that uses the hospital’s facilities and these entities are defined in § 413.65. exception to this rule is for those equipment would also be using the In accordance with our regulations at practicing predominantly in an FQHC or hospital’s EHR system and should be § 413.65, a provider-based department RHC). Section 1848(o)(1)(C)(ii) of the ineligible for an incentive payment. We or entity must operate under the Act defines the term ‘‘hospital-based seek comment as to whether EPs are ownership and financial and eligible professional’’ to mean an EP, using qualified EHR of the hospital in administrative control of the main such as a pathologist, anesthesiologist, ambulatory care settings. provider. We also note that the or emergency physician, who furnishes As noted previously, the statute provider-based department or entity of substantially all of his or her Medicare- provides that hospital-based EPs, ‘‘such the hospital comprises both the physical covered professional services during the as a pathologist, anesthesiologist, or facility where services are furnished and relevant EHR reporting period in a emergency physician,’’ are those EPs the personnel and equipment used to hospital setting (whether inpatient or that provide substantially all of their care for patients in those settings. In outpatient) through the use of the Medicare-covered professional services addition, § 413.65(d) specifies that the ‘‘ facilities and equipment of the hospital, in a hospital setting (whether inpatient financial operations of provider-based ’’ including the hospital’s qualified EHRs. or outpatient). Because the HITECH Act departments or entities must be fully ‘‘ This section indicates that the does not define the term hospital integrated within the financial system of setting,’’ we looked to existing statutes determination of whether an EP is a the main provider. Medicare makes and regulations that define and describe hospital-based EP shall be made on the payment to the hospital under the hospital settings for guidance in basis of the site of service, as defined by outpatient payment system for the defining ‘‘hospital setting’’ for purposes the Secretary, and without regard to the facility resources required for care that of this proposed rule. We welcome type of service provided by the EP or is furnished to hospital outpatients in comments on alternative approaches to any employment or billing arrangement its provider-based departments and interpreting the meaning of ‘‘hospital between the EP and any other provider entities, regardless of the specific type (for example, the hospital-based setting.’’ of hospital outpatient setting. Moreover, determination for an EP would not be First, section 1861(e) of the Act Medicare pays EPs for their professional affected by whether the EP is an defines the term a ‘‘hospital’’ to mean an services furnished to hospital employee of the hospital, under a institution that ‘‘is primarily engaged in outpatients at the facility rate under the contractual relationship with the providing, by or under the supervision Medicare Physician Fee Schedule hospital, or with respect to where he or of physicians, to inpatients (A) (MPFS), also regardless of the specific she has made a reassignment to the diagnostic services and therapeutic type of hospital outpatient setting, hospital for Part B billing purposes). services for medical diagnosis, recognizing that in all hospital Section 1903(t)(3)(D) of the Act defines treatment, and care of injured, disabled, outpatient settings the hospital bears the hospital-based EP in nearly identical or sick persons, or (B) rehabilitation terms. services for the rehabilitation of injured, cost of personnel, equipment, and In addition, as discussed below, disabled, or sick persons.’’ Therefore, we supplies for which payment would section 1848(a)(7)(D) of the Act, as propose that EPs that practice primarily otherwise be made to the EP under the added by section 4101(b) of the HITECH in inpatient hospital settings, as MPFS for services furnished in a non- Act, exempts hospital-based EPs from referenced in section 1861(e) of the Act, facility setting. Section 413.65(d) also the downward payment adjustment be considered hospital-based EPs. requires that the medical records for applied under section 1848(a)(7)(A)(i) of Because the parenthetical after the patients treated in the provider-based the Act to covered professional services term ‘‘hospital setting’’ in the statutory department or entity must be integrated provided during a payment year by EPs definition of hospital-based EP into a unified retrieval system (or cross who are not meaningful EHR users for specifically refers to both inpatient and reference) of the main provider. the relevant payment year beginning in outpatient hospital settings, we believe Moreover, an eligible hospital will 2015. the term ‘‘hospital setting’’ should be receive an incentive payment for its If an EP is providing ‘‘substantially defined to also include the outpatient medical records system if such system all’’ of their services in the hospital, we setting. So although a ‘‘hospital’’ is an is considered certified EHR technology believe it is reasonable to assume that institution that primarily provides and is meaningfully used by the the EP is also using the facilities and inpatient services, we propose to define hospital consistent with the equipment of the hospital, including the term ‘‘hospital setting’’ for purposes requirements of the final rule to this any qualified EHR implemented by the of the Medicare and Medicaid EHR rule. Because, by definition of the hospital. The statute uses ‘‘facilities and incentive payment programs to also requirements for provider-based equipment’’ to determine whether an EP include all outpatient settings where departments and entities, EPs who is a hospital-based EP. As ‘‘facilities and hospital care is furnished to registered furnish substantially all of their covered equipment’’ would generally be hospital outpatients. For purposes of professional services to hospital understood to apply to the hospital Medicare payment and conditions of outpatients use the hospital’s facility building and its medical and other participation, it is CMS’s longstanding and equipment, including the integrated equipment that is used in furnishing policy to consider as outpatient hospital medical record system, for which medical services, we believe it is settings those outpatient settings that payment is made by Medicare to the reasonable to assume that an EP are owned by and integrated both hospital, we believe these EPs should be providing substantially all of their operationally and financially into the considered hospital-based EPs, and thus services in a hospital is providing these entity, or main provider, that owns and excluded from the Medicare EP EHR services in the hospital building and operates the inpatient setting. For incentive payments. This is fully generally is also using its equipment, example, we consider as outpatient consistent with the definition of including qualified EHRs, and not hospital settings all types of outpatient hospital-based EPs in section bringing his or her own equipment to care settings in the main provider, on- 1848(o)(1)(C)(ii) of the Act.

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In summary, we propose that EPs that Hospital) are commonly recognized to payment. In other words, 3 percent provide substantially all of their be outpatient departments of the fewer EPs would be ineligible for the professional services in the inpatient hospital. An outpatient department of a EHR incentive payments if we define hospital setting, in any type of hospital will either meet the definition ‘‘substantially all’’ to mean at least 90 outpatient hospital setting, or in any of the ‘‘main provider,’’ a ‘‘department of percent rather than at least 75 percent. combination of inpatient and outpatient a provider,’’ or of having ‘‘provider- Because EPs providing 90 percent or hospital settings, be considered based status’’ as those terms are used in more of their services in one of these hospital-based EPs. § 413.65. Place of service codes 22 and sites as described above are not likely to We propose to consider the use of 23 are used to describe hospital expend significant resources related to place of service (POS) codes on outpatient settings that meet these EHRs in other, non-hospital settings, we physician claims to determine whether definitions under § 413.65 and are also believe this proposal is most consistent an EP furnishes substantially all of their subject to the conditions of participation with the law’s intent of not providing professional services in a hospital under part 482. incentive payments to EPs that are setting and is, therefore, hospital-based. The statutory definition of hospital- providing substantially all of their This code set is required for use in the based EP provides that to be considered services in a hospital setting (whether implementation guide adopted as the a hospital-based EP, the EP must inpatient or outpatient). However, we national standard for electronic provide ‘‘substantially all’’ of his or her are open to comments on other transmission of professional health care covered professional services in a proposals that are consistent with the law’s intent of not providing incentive claims under the provisions of the hospital setting, which we propose to Health Insurance Portability and payments to hospital-based physicians encompass all hospital inpatient and Accountability Act of 1996 (HIPAA). as defined in HITECH. In our proposed outpatient settings, including all HIPAA directed the Secretary of HHS to approach, a hospital-based eligible settings that meet the definition of the adopt national standards for electronic professional would be ineligible to main provider, department of a transactions. These standard receive an EHR incentive payment provider, or of having provider-based transactions require all health plans and under either Medicare or Medicaid, status. Therefore, we must identify the providers to use standard code sets to regardless of the type of service minimum percentage of an EP’s covered populate data elements in each provided, if more than 90 percent of professional services that must be transaction. The Transaction and Code their services are identified as being provided in a hospital setting in order Set Rule (65 FR 50312) adopted the ASC provided in places of service classified X12N–837 Health Care Claim: for the EP to be considered as providing under place of service codes 21, 22, or ‘‘ ’’ Professional, volumes 1 and 2, version substantially all of his or her covered 23. 4010, as the standard for electronic professional services in a hospital Accordingly, for both Medicare and ‘‘ submission of professional claims. This setting. We would define substantially Medicaid incentive payment purposes, standard names the POS code set all’’ as furnishing at least 90 percent of we propose that a hospital-based currently maintained by CMS as the services in a hospital setting, either eligible professional is defined as an EP code set to be used for describing sites inpatient or outpatient. We believe this who furnishes 90 percent or more of of service in such claims and is threshold appropriately balances our their covered professional services in available at http://www.cms.hhs.gov/ competing goals of ensuring that any of the above listed places of service. PlaceofServiceCodes/Downloads/ professionals are encouraged to A hospital-based EP would be ineligible POS_09_10_07_Rev_2_508.pdf. participate in the incentive program and to receive EHR incentive payments. From this code set, we propose to avoid duplicate payments to a (Based on preliminary claims data from consider the use of the following POS professional who is primarily using the the first 9 months of 2009, CMS codes indicating that the EP provided EHR technology of the hospital in which currently estimates that, under this the service in an inpatient or any type he or she furnishes services. While we proposed definition, about 27 percent of of outpatient hospital setting (including considered using 75 percent as a Medicare EPs (physicians) would be a PBD of a hospital) to determine threshold for determining whether an considered hospital-based and thus not whether an EP is a hospital-based EP is an hospital-based EP, we are eligible to receive any incentive eligible professional: concerned that such a standard could payments. We do not have any data on • 21—Inpatient Hospital—is a exclude EPs from receiving incentive Medicaid practitioners.) We propose to facility, other than psychiatric, which payments that perform a minority but make this determination, for Medicare primarily provides diagnostic, significant percentage of their services incentive payment purposes, as to therapeutic (both surgical and outside of inpatient or outpatient whether or not an EP is hospital-based nonsurgical), and rehabilitation services hospital settings and would have offices by annually analyzing an EP’s claims by, or under, the supervision of separate and independent from the history from the prior year. Therefore, physicians, to patients admitted for a hospital where they provide patient care for example, based on such analysis, an variety of medical conditions. services and for which they would have otherwise EP would be considered a • 22—Outpatient Hospital—is a costs to obtain an EHR system. Based on hospital-based EP and be ineligible for portion of a hospital which provides an analysis of 2008 Medicare claims incentive payments in 2011 if he/she diagnostic, therapeutic (both surgical data, if we define ‘‘substantially all’’ of provided 90 percent or more of his/her and nonsurgical), and rehabilitation covered services in a hospital setting to allowed services in one of the above services to sick or injured persons who mean that 75 percent or more of an EP’s listed places of service based on their do not require hospitalization or allowed services are associated with one 2010 Medicare claims data. The institutionalization. of the place of service codes listed hospital-based status of each EP would • 23—Emergency Room, Hospital—is above, we estimate that 65 percent of be reassessed each year, using claims a portion of a hospital where emergency EPs would be considered eligible to data from the year immediately diagnosis and treatment of illness or receive an EHR incentive payment. If we preceding the payment year. For injury is provided. increase this criterion to 90 percent, we Medicaid purposes, we are proposing Place of service codes 22 (Outpatient estimate that 68 of percent of EPs would that State Medicaid agencies make the Hospital) and 23 (Emergency Room, be eligible for the EHR incentive determination about whether or not an

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EP is hospital-based by analyzing an outpatient services. We believe this restrictions. There may be opportunities EP’s Medicaid claims data, or in the could provide an important incentive to avoid duplication of reporting case of EPs who deliver care via for hospital investment in EHRs for their requirements among our various Medicaid managed care programs, by outpatient primary care sites. We programs. In section II.A.3. of this analyzing either encounter data or other welcome comments on these issues proposed rule, we discuss how we will equivalent data sources, at the State’s including other ways that CMS, under avoid duplication of reporting option. There is an interest in assuring the current statute, could help meet the requirements for clinical quality that nearly all primary care providers objective that nearly all primary care measures. are meaningful users of EHR technology providers are meaningful users of EHR by 2014. However, this objective may technology by 2014. B. Medicare Fee-for-Service Incentives not be reached because of several We also seek comment on the extent 1. Incentive Payments for Eligible factors. to which hospitals install EHRs in their Professionals (EP) • Some primary care EPs who outpatient clinics as part of their provide services to Medicare and adoption of EHRs. In addition, we seek Section 1848(o)(1)(A) of the Act, as Medicaid beneficiaries would be comment on the way that hospitals with amended by section 4101(a) of the ineligible for the incentive payments. provider-based entities meet the HITECH Act, provides for incentive For example, we currently estimate that provider-based requirements at 42 CFR payments to EPs who are meaningful under this proposal, 12–13 percent of 413.65(d) if they have EHRs in any or users of certified EHR technology during family practitioners under Medicare all parts of the hospital. the relevant EHR reporting periods. would be considered hospital-based Finally, we seek comment on whether Section 1848(o)(1)(A)(i) of the Act under our proposed definition of we should use another method for provides that EPs who are meaningful hospital-based EP, and therefore would defining hospital-based EPs than what EHR users during the relevant EHR not be eligible for the EHR incentive we have proposed here. Any comments reporting period are entitled to an payments. (Note that we believe that should address implementation based incentive payment amount, subject to an these data could be applied generally to on the specific POS codes identified, annual limit, equal to 75 percent of the Medicaid physicians as well. However, and/or any complexities that would Secretary’s estimate of the Medicare Medicaid EPs include other result from not including all outpatient allowed charges for covered practitioners who also must meet settings owned and operated by and professional services furnished by the hospital-based eligibility requirements, integrated with the hospital in the EP during the relevant payment year. some of whom provide primary care determination of whether an EP is Under section 1848(o)(1)(B)(ii)(VI) of the services such as nurse practitioners.) hospital-based. Act, an EP is entitled to an incentive Although many of these family 7. Interaction With Other Programs payment for up to 5 years. In addition, practitioners may be serving in in accordance with section The HITECH Act addresses nonprimary care roles within the 1848(o)(1)(A)(ii) of the Act, there shall hospital setting (such as in emergency interactions between the Medicare EHR incentive program and the E-prescribing be no incentive payments made with departments or functioning as respect to a year after 2016. The hospitalists), those EPs performing Incentive Program authorized by MIPPA. Under section 1848(m)(2)(D) of incentive payments would be disbursed primary care services in the hospital from the Federal Supplementary setting would also not be eligible to the Act, as added by section 4101(f)(2)(B) of the HITECH Act, if a Medical Insurance Trust Fund, as receive EP incentive payments. If these provided for under section EPs were eligible to receive incentive Medicare FFS or MA EP receives an incentive payment from the Medicare 1848(o)(1)(A)(i) of the Act. As noted in payments, some might reassign them to section II.A. of this proposed rule, EPs the hospital, and the hospital could then EHR incentive program, the EP (or group practice) is not eligible to also who qualify for both the Medicare and use the EP’s incentive payments for Medicaid incentive payments must elect additional integrated outpatient EHR receive the incentive payment under the E-prescribing Incentive Program created to receive payments from one program systems. or the other. • As will be explained in the next by MIPPA. Given the payment timelines section of this proposed rule, the proposed in this rule for the Medicare a. Definitions hospital’s total incentive payment is EHR incentive program and the existing based on total inpatient services. As payment timeline for the E-prescribing In accordance with section result, a hospital with a large outpatient Incentive Program, we will know 1848(o)(5)(C) of the Act, we propose to department will not receive a higher whether an EP received a Medicare EHR add a definition of the term ‘‘eligible incentive payment as a result of their incentive payment before the E- professional’’ in our regulations at outpatient services. Prescribing Incentive Program payment § 495.100 to mean a physician as • Finally, as previously discussed, we is calculated. Thus we will exclude defined under section 1861(r) of the Act. are proposing that the Stage 1 those EPs (or group practices) who Section 1861(r) of the Act defines the meaningful use criteria for eligible accept a Medicare EHR incentive term ‘‘physician’’ to mean the following hospitals apply only to a hospital’s payment for a given year from being five types of professionals, each of inpatient setting. eligible for the E-Prescribing Incentive which must be legally authorized to Because of these factors, we are Program payment for that same year. practice their profession under state concerned that hospital investment in EPs receiving a Medicaid EHR incentive law: A doctor of medicine or their outpatient primary care sites is payment would remain eligible for the osteopathy, a doctor of dental surgery or likely to lag behind their investment in Medicare MIPAA E-Prescribing dental medicine, a doctor of podiatric their inpatient EHR systems. To address Incentive Program payment. medicine, a doctor of optometry, or a these concerns, as part of future As the HITECH Act does not specify chiropractor. As discussed in section rulemaking, we plan to consider ways to any other restrictions on participation in II.B.1.a of this proposed rule, in realign the meaningful use objectives other programs and participation in the accordance with section 1848(o)(1)(C) of and criteria to include a broader Medicare and Medicaid EHR incentive the Act, hospital-based EPs are not definition of hospital care to include programs, we do not propose any other eligible for an incentive payment.

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Section 1848(o)(5)(A) of the Act related incentive payments to EPs. in payment limits for EPs who first defines covered professional services as Specifically, section 1848(o)(1)(B) of the demonstrate meaningful use of certified having the same meaning as in section Act provides that the incentive payment EHR technology after 2013. Specifically, 1848(k)(3) of the Act, that is, services for an EP for a given payment year shall if the EP’s first payment year is after furnished by an eligible professional for not exceed the following amounts: 2013, then the annual limit on the which payment is made under, or is • For the EP’s first payment year, for incentive payment equals the annual based on, the Medicare physician fee such professional, $15,000 (or, $18,000 limit applicable to an EP whose first schedule. if the EP’s first payment year is 2011 or payment year is 2013. Accordingly, if In accordance with section 1848(a)(1) 2012). the EP’s first payment year is 2014, the • For the EP’s second payment year, of the Act, the Medicare allowed charge EP’s maximum incentive payment will $12,000. for covered professional services is the be $12,000 in 2014, $8,000 in 2015, and • For the EP’s third payment year, $4,000 in 2016. Section 1848(o)(1)(B)(v) lesser of the actual charge or the $8,000. Medicare physician fee schedule • For the EP’s fourth payment year, of the Act provides that if the EP’s first amount established in section 1848 of $4,000. payment year is after 2014, then the the Act. As specified under section • For the EP’s fifth payment year, applicable incentive payment limit for 1848(o)(1)(A)(i), the Secretary’s estimate $2,000. such year and any subsequent year shall of allowed charges is based on claims • For any succeeding year, $0. be $0. In other words, an EP who does submitted to Medicare no later than 2 Under section 1848(o)(1)(B)(iv) of the not qualify to receive an EHR-related months following the end of the Act, for EPs who predominantly furnish incentive payment prior to 2015 will not relevant payment year. We propose to services in a geographic HPSA (as receive any of these incentive payments. codify these specifications and designated by the Secretary under Table 22 shows the maximum incentive definitions in our regulations at [cite section 332(a)(1)(A) of the Public Health payment amounts available to EPs proposed regulation range]. Service (PHS) Act), the incentive under Medicare FFS. (As noted above b. Incentive Payment Limits payment limitation amounts for each and discussed further below, these payment year are increased by 10 limits are increased by 10 percent for Section 1848(o)(1)(B)(i) of the Act sets percent. Section 1848(o)(1)(B)(iii) of the EPs who predominantly furnish services forth the annual limits on the EHR- Act also provides for a phased reduction in an HPSA.)

TABLE 22—MAXIMUM TOTAL AMOUNT OF EHR INCENTIVE PAYMENTS FOR A MEDICARE EP WHO DOES NOT PREDOMINANTLY FURNISH SERVICES IN A HPSA

First CY in which the EP receives an incentive payment Calendar year 2015– 2011 2012 2013 2014 subsequent years

2011 ...... $18,000 ...... 2012 ...... 12,000 $18,000 ...... 2013 ...... 8,000 12,000 $15,000 ...... 2014 ...... 4,000 8,000 12,000 $12,000 ...... 2015 ...... 2,000 4,000 8,000 8,000 $0 2016 ...... 2,000 4,000 4,000 0

Total ...... 44,000 44,000 39,000 24,000 0

The following examples illustrate recognized for purposes of this incentive. performed by the EP from January 1, 2012 how the payment amount would be Therefore, for payment year 2011, the through December 31, 2012, and submitted to determined: incentive payment in this case would be, the appropriate Medicare administrative $10,000 × .75 = $7,500, based on claims for contractor (MAC/carrier) on or before • Example 1: EP that receives the covered professional services furnished by February 28, 2013. maximum payment. For payment year 2011, the EP from January 1, 2011 through the incentive payment for an EP would be, December 31, 2011, and submitted to the c. Increase in Incentive Payment for EPs subject to a payment limit of $18,000, equal appropriate Medicare administrative Who Predominantly Furnish Services in to 75 percent of the EP’s Medicare physician contractor (MAC) or carrier on or before a Geographic Health Professional fee schedule allowed charges for CY 2011 (in February 29, 2012. Shortage Area (HPSA) this case, the maximum allowed charges We propose, for each subsequent Section 1848(o)(1)(B)(iv) of the Act recognized for the purposes of the incentive, payment year, to use the annual allowed × provides that the amount of the annual or $24,000 .75 = $18,000), estimated based charges and claims in a similar manner on claims for covered professional services incentive payment limit for each to calculate the Secretary’s estimate of furnished by the EP from January 1, 2011 payment year be increased by 10 allowed charges for purposes of through December 31, 2011, and submitted to percent for EPs who predominantly computing the incentive payment. the appropriate Medicare administrative furnish services in an area that is contractor (MAC/carrier) on or before • Example: For payment year 2012, the designated by the Secretary (under February 29, 2012. incentive payment issued to an EP would be, section 332(a)(1)(A) of the PHS Act) as • Example 2: EP that receives less than subject to a payment limit (that is, $18,000 a geographic health professional the maximum payment. Assume for this if it is the first payment year, $12,000 if it is example that the EP’s estimated total allowed the second payment year), equal to 75 shortage area (HPSA). Section charges for covered professional services are percent of the EP’s Medicare physician fee 332(a)(1)(A) of the PHS Act refers to $10,000 which is less than the $24,000 schedule allowed charges for CY 2012, based geographic HPSAs, or areas that have maximum allowed charges that could be on claims for covered professional services been determined to have a shortage of

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health professionals, based on the limit increase, we would then make an designated as a geographic HPSA as of population-to-provider ratio and other additional lump sum payment to reflect December 31 of the prior year would be factors. HPSAs are located in every that increased limit amount based on eligible to receive the 10 percent EHR State, and in both rural and urban areas. the estimated allowable charges for that HPSA payment limit increase during the Geographic HPSAs are defined in 42 EP for the prior year. We propose that current year, provided the EP qualifies CFR Part 5 and include primary medical the additional amount would be paid no for the EHR HPSA payment limit for the care, dental, and mental health HPSAs. later than 120 days after the end of the current year. For example, an EP In accordance with the statute, we will prior year for which the EP was eligible furnishing a covered professional increase the limits per payment year by for the 10 percent EHR HPSA payment service in an area that was designated as 10 percent for EHR-related incentive limit increase. a geographic HPSA as of December 31, payments to EPs who predominantly Most physicians furnishing services 2010, and who qualifies to receive the furnish covered professional services in in a HPSA furnish 100 percent of their EHR HPSA payment in 2011, also a geographic primary medical care, covered services in a HPSA. Based on would receive a 10 percent EHR dental, or mental health HPSA. our data, we found very few physicians incentive payment limit increase for We propose that an EP be considered provide even a modest percentage of 2011. as ‘‘predominantly’’ furnishing covered their services across HPSA and non- Section 1833(m)(2) of the Act also professional services in a geographic HPSA areas. We estimate that about 17 provides that geographic HPSAs that percent of EPs would qualify for the 10 HPSA if more than 50 percent of the consist of an entire county be identified percent EHR HPSA payment limit EP’s Medicare covered professional and the bonus paid automatically. We increase, provided they satisfy the other services are furnished in a geographic publish a list annually of the zip codes requirements for the incentive payment. HPSA. Using ‘‘more than 50 percent’’ as that are in these areas on our Web site Section 1848(o)(1)(B)(iv) of the Act also the criterion to define ‘‘predominantly’’ at http://www.cms.hhs.gov/ authorizes us to apply the provisions of is consistent with how the term is HPSAPSAPhysicianBonuses/ sections 1833(m) and (u) of the Act in defined in general parlance as well as 01_Overview.asp#TopOfPage. implementing this 10 percent EHR how the definition is used for purposes Physicians furnishing Medicare covered HPSA payment limit increase, as the of other aspects of the Medicare professional services in a zip code that Secretary determines appropriate. program. is on this list automatically receive the To determine whether an EP has Section 1833(m) of the Act establishes HPSA bonus payment. Physicians furnished more than 50 percent of his/ the HPSA bonus program, which furnishing Medicare covered her covered professional services in a provides a 10 percent bonus to professional services in a zip code that geographic HPSA, we propose to utilize physicians who furnish Medicare is not on this list but that was frequency of services provided over a 1- covered professional services in a designated as a geographic HPSA as of year period from January 1 to December geographic HPSA. Section 1833(u) of December 31 of the prior year must use 31, rather than basing it on the the Act establishes the Physician a modifier when submitting a Medicare percentage of allowed charges. Our data Scarcity Area bonus program, which claim in order to receive the HPSA indicates that most physicians either provided a 5 percent bonus to bonus. provide all or none of their services in physicians who furnish Medicare a geographic HPSA, so we believe that covered professional services in areas We note that we would only list a zip our proposal to base eligibility for the 10 that are determined to physician code on our Web site if the entire percent EHR HPSA payment limit scarcity areas. (Note: The authority for geographic area encompassed by the zip increase on frequency, rather than the Physician Scarcity Area program code is designated as a geographic allowed charges, will have little or no ended on June 31, 2008.) HPSA. If a zip code encompasses both impact on the determination of whether Section 1833(m)(1) of the Act areas designated as a geographic HPSA an EP is eligible for the EHR HPSA provides that physicians who furnish and areas that are not a geographic payment limit increase. To apply the covered professional services in a year HPSA, we will not list the zip code on payment limit increase, we will first in an area that is designated as a our Web site. Our list also will not need to determine whether more than geographic HPSA prior to the beginning include zip codes for areas designated 50 percent of an EP’s covered of the year are eligible to receive the as geographic HPSAs after we create the professional services were furnished in HPSA bonus for services furnished zip code list (but before December 31). a geographic HPSA during a particular during the current year. We have EPs furnishing Medicare covered payment year. We propose to first make interpreted this to mean that bonus professional services in an area eligible the generally applicable incentive payments should continue throughout for the EHR HPSA payment limit payment to the EP based on an EP’s the current year, even if the area loses increase that is not included in the list estimated allowed charges for the its designation as a geographic HPSA of zip codes for automatic payment relevant payment year. during the current year. Physicians would need to use a modifier when Once we compile a full year of data, furnishing covered professional services submitting a claim to identify their we would determine eligibility for the in an area that is not designated as a eligibility for the HPSA EHR payment EHR HPSA payment limit increase for geographic HPSA by December 31 of the limit increase. the payment year based on whether the prior year are not eligible to receive the Table 23 shows the maximum total EP provided more than 50 percent of HPSA bonus for the current year, even EHR HPSA payment limit for an EP who his/her services in a geographic HPSA if the area is subsequently designated as predominantly furnishes covered during the payment year. The a geographic HPSA during the current professional services in a HPSA as determination would be made based on year. We propose to apply these same described previously above for CYs claims submitted not later than 2 rules for the 10 percent EHR HPSA 2011 through 2016. Table 24 shows the months after the end of the year. If we payment limit increase provided under maximum additional amount of determine that the EP provided more section 1848(o)(1)(B)(iv) of the Act. incentive payments for a Medicare EP than 50 percent of his/her services in a Specifically, we propose that EPs who who predominantly furnishes services geographic HPSA and is therefore predominately furnish covered in a HPSA. (That is, Table 24 shows the eligible for the EHR HPSA payment professional services in an area that is difference between Tables 22 and 23.)

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TABLE 23—MAXIMUM TOTAL AMOUNT OF INCENTIVE PAYMENTS FOR A MEDICARE EP WHO PREDOMINANTLY PERFORMS SERVICES IN A HPSA

Year that EP becomes EHR user in a HPSA 2015 and Calendar year subsequent 2011 2012 2013 2014 years

2011 ...... $19,800 ...... 2012 ...... 13,200 $19,800 ...... 2013 ...... 8,800 13,200 $16,500 ...... 2014 ...... 4,400 8,800 13,200 $13,200 ...... 2015 ...... 2,200 4,400 8,800 8,800 $0 2016 ...... 2,200 4,400 4,400 0

Total ...... 48,400 48,400 42,900 26,400 0

TABLE 24—MAXIMUM ADDITIONAL AMOUNT OF INCENTIVE PAYMENTS FOR A MEDICARE EP WHO PREDOMINANTLY PERFORMS SERVICES IN A HPSA

Year that an EP first receives the incentive payment for Medicare 2015 and Calendar year covered professional services furnished in a geographic HPSA subsequent 2011 2012 2013 2014 years

2011 ...... $1,800 ...... 2012 ...... 1,200 $1,800 ...... 2013 ...... 800 1,200 $1,500 ...... 2014 ...... 400 800 1,200 $1,200 ...... 2015 ...... 200 400 800 800 $0 2016 ...... 200 400 400 0

Total ...... 4,400 4,400 3,900 2,400 0

d. Form and Timing of Payment entity to bill for the physician’s services. review their existing contract to Section 1848(o)(1)(D)(i) of the Act, as Therefore, EPs are allowed to reassign determine whether it currently provides amended by section 4101(a) of the their incentive payment to their for reassignment of the incentive HITECH Act, provides that the incentive employer or an entity which they have payment to the employer/entity or payments may be disbursed as a single a valid employment agreement or needs to be revised. consolidated payment or in periodic contract providing for such The statute provides that the installments as the Secretary may reassignment, consistent with all rules incentive payment shall be paid to the specify. We propose to make a single, governing reassignments. The statute employer or facility in the cases consolidated, annual incentive payment does not address the case where the EP described in clause (A) of section to EPs. We believe that making a single, has multiple employers/contractual 1842(b)(6) of the Act. This clause consolidated payment would be the arrangements, and it would be difficult provides that payment for a service least administratively burdensome for operationally for CMS to allocate the provided to an individual may not be both CMS and most EPs. We expect that incentive payment among two or more paid to anyone other than the individual many EPs who demonstrate meaningful individuals/entities. Therefore, in or the practitioner who provided the use of certified EHR technology will § 495.10(e) we are proposing to preclude service, except that the practitioner may receive the maximum incentive an EP from reassigning the incentive reassign his or her right to payment to payments. We propose that payments payment to more than one employer or his or her employer or an entity with would be made on a rolling basis, as entity. We believe that the question of whom he or she has a contractual soon as we ascertain that an EP has whether the EP has reassigned the arrangement if certain conditions are demonstrated meaningful use for the incentive payment to the employer/ met. Any such authorization must be in applicable reporting period (that is, 90 entity under his or her contract with the accordance with our regulations at 42 days for the first year or a calendar year employer/entity, including any pre- CFR 424.73 and 42 CFR 424.80. for subsequent years), and reached the existing contract between the parties, is Section 1848(o)(1)(D)(ii) of the Act threshold for maximum payment. a matter of contract interpretation that requires the Secretary to establish rules Section 1848(o)(1)(A) of the Act should be resolved by the parties to coordinate the incentive payments provides that ‘‘with respect to covered themselves. We note that nothing in the made among practices for an EP professional services provided by an statute or our existing regulations would furnishing covered professional services eligible professional,’’ the incentive prohibit an EP from assigning to the in more than one practice, including the payment ‘‘shall be paid to the eligible employer/entity only the allowable application of the limits on the amounts professional (or to an employer or charges for his or her professional of the incentive payments. To facility in the cases described in clause services, with the EP retaining any implement this requirement, we (A) of section 1842(b)(6)).’’ Section incentive payment, or vice versa. If an propose to use the EP’s Medicare 1842(b)(6)(A) of the Act allows for EP will reassign his or her incentive enrollment information to determine reassignment to an employer or entity payment to an employer/entity with whether an EP belongs to more than one with which the physician has a valid which the EP has a contractual practice (that is, whether the EP’s contractual arrangement allowing the arrangement, the parties will need to National Provider Identifier (NPI) is

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associated with more than one practice). apply. The HITECH Act includes a proposing a new § 495.104 to implement In cases where the EP is associated with significant hardship exception, this provision. For purposes of this more than one practice, we propose that discussed below, which, if applicable, provision, section 1886(n)(6)(B) of the EPs select one tax identification number could exempt certain EPs from this Act defines ‘‘eligible hospitals’’ as to receive any applicable EHR incentive payment adjustment. The payment ‘‘subsection (d) hospitals,’’ as that term payment. adjustments will not apply to hospital- is defined in section 1886(d)(1)(B) of the Although it would not be impossible based EPs, as defined elsewhere. Act. Section 1886(d)(1)(B) of the Act for Medicare contractors to make The term ‘applicable percent’ means: generally defines a ‘‘subsection (d) proportional EHR incentive payments to ‘‘(I) for 2015, 99 percent (or, in the case hospital’’ as a ‘‘hospital located in one of each TIN associated with a provider, we of an EP who was subject to the the fifty States or the District of believe this option would entail the application of the payment adjustment Columbia.’’ The term therefore does not creation of highly complex and if the EP is not a successful electronic include hospitals located in the potentially unwieldy administrative prescriber under section 1848(a)(5) for territories or hospitals located in Puerto systems. Therefore, we believe our 2014, 98 percent);’’ ‘‘(II) for 2016, 98 Rico. Section 1886(d)(9)(A) of the Act proposal to permit the EP to select one percent; and (III) for 2017 and each separately defines a ‘‘subsection (d) TIN to which we will make any EHR subsequent year, 97 percent.’’ Puerto Rico hospital’’ as a hospital that incentive payment is the most efficient In addition, section 1848(a)(7)(iii) of is located in Puerto Rico and that alternative. We have proposed that the Act provides that if for 2018 and ‘‘would be a subsection (d) hospital payments would be made on a rolling subsequent years the Secretary finds * * * if it were located in one of the 50 basis, as soon as we ascertain that an EP that the proportion of EPs who are states.’’ Therefore, because section has demonstrated meaningful use for meaningful EHR users is less than 75 4102(a)(1) of the HITECH Act does not the applicable reporting period (that is, percent, the applicable percent shall be refer to ‘‘subsection (d) Puerto Rico 90 days for the first year or a calendar decreased by 1 percentage point from hospitals,’’ incentive payments for year for subsequent years), and reached the applicable percent in the preceding meaningful users of certified EHR the threshold for maximum payment. If year, but in no case shall the applicable technology are not available under this we were to adopt an alternative policy, percent be less than 95 percent. provision to hospitals located in Puerto permitting EHR incentive payments to Significant Hardship Exception— Rico. The provision does apply to be made to multiple TINs, we would Section 1848(a)(7)(B) of the Act inpatient, acute care hospitals located in need to calculate the percentage of provides that the Secretary may, on a the State of Maryland. These hospitals covered professional services billed by case-by-case basis, exempt an EP who is are not currently paid under the IPPS in each TIN for that EP, and the total of not a meaningful EHR user for the year accordance with a special waiver any incentive payment amount would from the application of the payment provided by section 1814(b)(3) of the be divided and paid accordingly. Thus, adjustment if the Secretary determines Act. Despite this waiver, the Maryland a policy permitting payment to multiple that compliance with the requirements hospitals continue to meet the TINs would conflict with our proposal for being a meaningful EHR user would definition of a ‘‘subsection (d) hospital’’ to make payment on a rolling basis as result in a significant hardship, such as because they are located in the 50 states. EPs meet the criteria to receive the in the case of an EP who practices in a The statutory definition of a subsection maximum EHR incentive payment. An rural area without sufficient Internet (d) hospital also does not apply to additional confounding factor is the access. The exemption is subject to hospitals and hospital units excluded possibility that an EP might change annual renewal, but in no case may an under section 1886(d)(1)(B) from the group affiliations during the year. EP be granted a hardship exemption for IPPS, such as psychiatric, rehabilitation, Therefore, we believe the most judicious more than 5 years. long term care, children’s, and cancer policy would be to permit the EP to We will include specific proposals to hospitals. For purposes of this designate one TIN to which payment implement these payment adjustments provision, we will provide incentive will be made. for EPs who are not meaningful EHR payments to hospitals as they are e. Payment Adjustment Effective in CY users in future rulemaking prior to the distinguished by provider number in 2015 and Subsequent Years for EPs Who 2015 effective date. We welcome hospital cost reports. Incentive Are Not Meaningful Users of Certified comments on these payment payments for eligible hospitals will be EHR Technology adjustments and any comments received calculated based on the provider number used for cost reporting Section 1848(a)(7) of the Act, as will be considered in developing future proposals to implement these purposes, which is the CCN of the main amended by section 4101(b) of the provider (also referred to as OSCAR HITECH Act, provides for payment provisions, including comments on the possible circumstances for which we number). Payments to eligible hospitals adjustments effective for CY 2015 and are made to each provider of record. The should allow an EP to qualify for the subsequent years for EPs who are not criteria for being a meaningful EHR significant hardship exception. meaningful EHR users during the user, and the manner for demonstrating relevant EHR reporting period for the 2. Incentive Payments for Hospitals meaningful use, are discussed in section year. In general, beginning in 2015, if an B.2. of this proposed rule. EP is not a meaningful EHR user for any a. Definition of Eligible Hospital for EHR reporting period for the year, then Medicare b. Incentive Payment Calculation for the Medicare physician fee schedule Section 1886(n) of the Act, as Eligible Hospitals amount for covered professional amended by section 4102(a)(1) of the Section 1886(n)(2) of the Act, as services furnished by the EP during the HITECH Act, provides for incentive amended by 4102(a) of HITECH, year (including the fee schedule amount payments, beginning in FY 2011 (that is, describes the methodology for for purposes of determining a payment October 1, 2010 through September 30, determining the incentive payment based on the fee schedule amount) is 2011) for eligible hospitals that are amount for eligible hospitals that are adjusted to equal the ‘applicable meaningful users of certified EHR meaningful users of certified EHR percent’ of the fee schedule amount technology during the EHR reporting technology during the EHR reporting (defined below) that would otherwise period for the payment year. We are period for a payment year. In general,

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that section requires the incentive FY prior to the FY that serves as the payment year as the basis for payment for each payment year to be payment year as the basis for making preliminary payment. Final payment calculated as the product of: (1) An preliminary incentive payments. Final would be made on the basis of the data initial amount; (2) the Medicare share; payments would be determined at the from the hospital fiscal year that ends and (3) a transition factor applicable to time of settling the cost report for the during the FY that serves as the that payment year. hospital fiscal year that ends during the payment year at the time of the As amended by section 4201(a) of the payment year, and settled on the basis settlement of the cost report for the HITECH Act, section 1886(n)(2)(A)(i) of of the hospital discharge data from that latter period. the Act defines the initial amount as the cost reporting period. Section 1886(n)(2)(D) of the Act, as sum of a ‘‘base amount,’’ as defined in Example: FY 2011 begins on October 1, amended by section 4102 of the HITECH section 1886(n)(2)(B) of the Act, and a 2010 and ends on September 30, 2011. For Act, defines the numerator and ‘‘discharge related amount,’’ as defined an eligible hospital with a cost reporting denominator of this fraction in terms of in section 1886(n)(2)(C) of the Act. The period running from July 1, 2010 through estimated Medicare FFS and managed base amount is $2,000,000, as defined in June 30, 2011, we would employ the relevant care inpatient bed days, estimated total section 1886(n)(2)(B) of the Act. The data from the hospital’s cost reporting period inpatient bed-days, and charges for ending June 30, 2010 in order to determine term ‘‘discharge related amount’’ is charity care. Specifically, section the incentive payment for the hospital during 1886(n)(2)(D)(i) of the Act defines the defined in section 1886(n)(2)(C) of the FY 2011. This timeline would allow us to Act as ‘‘the sum of the amount, have the relevant data available for numerator of the Medicare share fraction as the sum of— estimated based upon total discharges determining payments in a timely manner for • for the eligible hospital (regardless of the first and subsequent payment years. This The estimated number of inpatient- any source of payment) for the period, timeline would also render it unnecessary to bed-days (as established by the for each discharge up to the 23,000th develop a cumbersome process to extract and Secretary) which are attributable to employ discharge data across more than one discharge as follows: individuals with respect to whom hospital cost reporting period in order to payment may be made under part A; (i) For the first through the 1,149th determine the discharge related amount for a and discharge, $0. FY-based payment period. However, final • The estimated number of inpatient- payments would be based on hospital (ii) For the 1,150th through the 23,000th bed-days (as so established) that are discharge, $200. discharge data from the cost report ending (iii) For any discharge greater than the June 30, 2011, and determined at the time of attributable to individuals who are 23,000th, $0. settlement for that cost reporting period. enrolled with a MA organization under Part C. In addition to the base amount, the c. Medicare Share We propose to determine the numbers discharge related amount provides an As previously discussed, the initial of Medicare Part A and Part C inpatient- additional $200 for each hospital amount must be multiplied by the bed-days using the same data sources discharge during a payment year, Medicare share and an applicable and methods for counting those days beginning with a hospital’s 1,150th transition factor to determine the that we employ in determining discharge of the payment year, and incentive payment to an eligible Medicare’s share for purposes of making ending with a hospital’s 23,000th hospital for an incentive payment year. payments for direct graduate medical discharge of the payment year. No As added by section 4102(a) of the education costs, as provided under additional payment is made for HITECH Act, section 1886(n)(2)(D) of section 1886(h) of the Act and § 413.75 discharges prior to the 1,150th the Act defines the Medicare share for of our regulations. Specifically, we discharge, or for those discharges purposes of calculating incentive propose to derive ‘‘the estimated number subsequent to the 23,000th discharge. payments as a fraction based on of inpatient-bed-days * * * attributable Section 1886(n)(2)(C) of the Act, as estimated Medicare FFS and managed to individuals with respect to whom amended by section 4102(a) of the care inpatient bed days, divided by payment may be made under part A’’ HITECH Act, specifies that a ‘‘12-month estimated total inpatient bed-days, from lines 1, 6 through 9, 10 and 14 in period selected by the Secretary’’ may be modified by charges for charity care. column 4 on Worksheet S–3, Part I of employed for purposes of determining This section specifies that the Medicare the Medicare cost report. The data the discharge related amount. While the share fraction is determined for the entered on these lines in the cost report statute specifies that the payment year incentive payment year ‘‘for an eligible include all patient days attributable to is determined based on a Federal fiscal hospital for a period selected by the Medicare inpatients, excluding those in year (FY), section 1886(n)(2)(C) of the Secretary.’’ As in the case of the units not paid under the IPPS and Act provides the Secretary with discharge data discussed above, this excluding nursery days. Similarly, we authority to determine the discharge clause provides the Secretary with propose to derive the ‘‘estimated number related amount on the basis of discharge authority to determine the Medicare of inpatient-bed-days attributable * * * data from a relevant hospital cost share fraction on the basis of data from to individuals who are enrolled with a reporting period, for use in determining a relevant hospital cost reporting period, MA organization under Part C’’ from line the incentive payment during a FY. FYs for use in determining the incentive 2 in column 4 on Worksheet S–3, Part begin on October 1 of each calendar payment during a FY. For purposes of I of the Medicare cost report. The year, and end on September 30 of the administrative simplicity and timeliness methodology and data sources for subsequent calendar year. Hospital cost equivalent to those discussed above making these bed day determinations reporting periods can begin with any with regard to discharge data, we are not only well established, but also month of a calendar year, and end on propose, for each eligible hospital well known and understood within the the last day of the 12th subsequent during each incentive payment year, to hospital community. We therefore see month. For purposes of administrative employ data on the hospital’s Medicare no reason to develop or propose any simplicity and timeliness, we propose, fee-for-service and managed care alternative approach for determining the for each eligible hospital during each inpatient bed days, total inpatient bed- ‘‘subsection (d) hospital’’ numbers of incentive payment year, to use data on days, and charges for charity care from Medicare Part A and Part C inpatient- the hospital discharges from the the hospital fiscal year that ends during bed-days for purposes of calculating hospital fiscal year that ends during the the FY prior to the FY that serves as the these incentive payments.

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Section 1886(n)(2)(D)(ii) of the Act charity care, to estimated total hospital form as soon as possible. defines the denominator of the Medicare charges during a period increases. In (Recommendation 2A–3) share fraction as the product of— this case, the effect of this factor on the In the August 22, 2007 Federal • The estimated total number of denominator of the Medicare share Register (72 FR 47406), we published a inpatient-bed-days with respect to the fraction is therefore to increase the final rule responding to the MedPAC eligible hospital during such period; denominator (as the total number of recommendation. We stated in that final and inpatient-bed days is multiplied by a rule that we were undertaking a major • The estimated total amount of the relatively higher charity care charge update to the Worksheet S–10 form and eligible hospital’s charges during such ratio), as a hospital provides a smaller accompanying instructions based on the period, not including any charges that proportion of charity care. A larger panel’s discussions with MedPAC. are attributable to charity care (as such denominator in turn decreases the In the July 2, 2009 Federal Register term is used for purposes of hospital Medicare share factor, providing for (74 FR 31738), we accordingly cost reporting under Title XVIII), lower incentive payments, as a hospital published a proposed collection to divided by the estimated total amount of provides a lower proportion of charity revise the Hospital and Hospital Health the hospitals charges during such care. Care Complex Cost Report, Form CMS– period. The data and methods for determining 2552–10, which included a revised As in the case of Medicare Part A and this charity factor for purposes of the Worksheet S–10 form. This worksheet Part C inpatient-bed days, for purposes Medicare share fraction warrants more may change based on public comments. of determining total inpatient-bed days extensive discussion. Section 112 of the The revised cost report and in the denominator of the Medicare Medicare, Medicaid, and State accompanying instructions that include share fraction, we propose to use the Children’s Health Insurance Program the definition of charity care based on same data sources, and the same (SCHIP) Balanced Budget Refinement MedPAC’s recommendations are methods, that we employ in Act of 1999 (Pub. L. 106–113) directs currently in the Paperwork Reduction determining Medicare’s share for the Secretary to require prospective Act clearance process. We anticipate purposes of making payments for direct payment system hospitals to submit graduate medical education costs. that the revised hospital cost report will data on the costs incurred by the Specifically, we will derive the relevant be effective for cost reporting periods hospitals for providing inpatient and data from lines 1, 6 through 9, 10 and beginning on or after February 1, 2010. 14 in column 6 on Worksheet S–3, Part outpatient hospital services for which For the purposes of this proposed I of the Medicare cost report. The data the hospitals are not compensated, rule, we propose to define charity care entered on these lines in the cost report including non-Medicare bad debt, as part of uncompensated and indigent include all patient days attributable to charity care, and charges for medical care described for Medicare cost inpatients, excluding those in units not and indigent care as part of the reporting purposes in the Medicare cost paid under the IPPS. Medicare cost report. report instructions at section 4012 of the In the August 1, 2000 Federal Provider Reimbursement Manual (PRM), d. Charity Care Register (65 FR 47054), we published a Part 2; Worksheet S–10; Hospital In determining the denominator of the final rule that set forth changes to the Uncompensated and Indigent Care Data. Medicare share fraction, we also must IPPS and FY 2001 rates. In that final Subsection (d) hospitals and CAHs are determine any charges that are rule we responded to comments on required to complete the Worksheet attributable to charity care furnished by implementing section 112 of Public Law S–10. an eligible hospital or CAH. The 106–113. We informed the public that As part of the Form CMS–2552–10 exclusion of charges attributable to the hospital Medicare cost report and described above, the revised Worksheet charity care has the effect of decreasing instructions would be revised to collect S–10 instructions define the denominator of the Medicare share uncompensated care data. As a result of uncompensated care as follows: ‘‘*** fraction as the proportion of charity care meeting with, and receiving input from, charity care and bad debt which (charity care charge ratio) provided by a various hospital industry groups, includes non-Medicare bad debt and hospital increases. This is because the ‘‘Worksheet S–10; Hospital non-reimbursable Medicare bad debt. ratio of estimated total hospital charges, Uncompensated and Indigent Care Uncompensated care does not include not including charges attributable to Data’’, was added to the Medicare cost courtesy allowances or discounts given charity care, to estimated total hospital reporting forms to implement section to patients.’’ These instructions further charges during a period decreases, 112 of Public Law 106–113. The define charity care to include health relatively speaking, as a hospital Worksheet S–10 was placed in effect for services for which a hospital provides a greater proportion of charity cost reporting periods beginning on or demonstrates that the patient is unable care. The effect of this factor on the after April 30, 2002. to pay. Charity care results from a denominator of the Medicare share In May 2005, the Medicare Payment hospital’s policy to provide all or a fraction is therefore to decrease the Advisory Commission (MedPAC) portion of services free of charge to denominator (as the total number of convened an expert panel to address patients who meet certain financial inpatient-bed days is multiplied by a concerns on the usefulness of the criteria. For Medicare purposes, charity relatively lower charity care charge Worksheet S–10 data. Based on the care is not reimbursable, and unpaid ratio), as a hospital provides a greater panel discussion, MedPAC issued a list amounts associated with charity care are proportion of charity care. A smaller of recommended changes to the not considered as an allowable denominator increases the Medicare Worksheet S–10. In addition, in its Medicare bad debt. Therefore, we are share factor, providing for higher March 2007 report to Congress, proposing to use the charity care incentive payments, to a hospital that MedPAC recommended that the charges that are reported on line 19 of provides a greater proportion of charity Secretary should improve the form and the revised Worksheet S–10 in the care. Conversely, as a hospital provides accompanying instructions for computation of the Medicare share of a lower proportion of charity care, the collecting data on uncompensated care the incentive payments. The revised ratio of estimated total hospital charges, in the Medicare cost report; and require instructions for line 19 of Worksheet not including charges attributable to hospitals to report using the revised S–10 state the following:

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Enter the total initial payment obligation of denominator in section M = [# of Inpatient Bed Days for Part A patients who are given a full or partial 1886(n)(2)(D)(ii)(II) of the Act to be 1. Beneficiaries] + [# of Inpatient Bed Days discount, based on the hospital’s charity care In this proposed rule, we are for MA Beneficiaries] criteria (measured at full charges), for care T = [# of Total Inpatient Bed Days] delivered during this cost reporting period specifically soliciting public comments C = [Total Charges ¥ Charges for Charity for the entire facility. For uninsured patients, on the charity care financial criteria Care*]/[Total Charges] including patients with coverage from an established by each hospital and *If data on charity care is not available, entity that does not have a contractual reviewed by the MACs, the collection of then the Secretary would use data on relationship with the provider (column 1), charity care data on the Worksheet uncompensated care as a proxy. If the proxy this is the patient’s total charges. For patients S–10, and whether proxies for charity data is not also available, then ‘‘C’’ would be covered by a public program or private care may be developed with other data equal to 1. insurer with which the provider has a available to us. contractual relationship (column 2), this is TRANSITION FACTOR the deductible and coinsurance payments e. Transition Factor required by the payer. Include charity care Transition for all services except physician and other As we have previously discussed, the Consecutive payment year factor professional services. Do not include charges initial amount must be multiplied not for either uninsured patients given discounts only by the Medicare share fraction, but 1 ...... 1 without meeting the hospital’s charity care also by an applicable transition factor in 2 ...... 3⁄4 criteria or patients given courtesy discounts. 1 order to determine the incentive 3 ...... ⁄2 Charges for non-covered services provided to 1 payment to an eligible hospital for an 4 ...... ⁄4 patients eligible for Medicaid or other indigent care program (including charges for incentive payment year. Section days exceeding a length of stay limit) can be 1886(n)(2)(E)(i) of the Act designates f. Duration and Timing of Incentive included, if such inclusion is specified in the that the applicable transition factor Payments hospital’s charity care policy and the patient equals 1 for the first payment year, Section 1886(n)(2)(E)(i) of the Act meets the hospital’s charity care criteria. three-fourths for the second payment establishes that an eligible hospital that Under section 1886(n)(2)(D) of the Act, year, one-half for the third payment is a meaningful user of certified EHR if the Secretary determines that data are year, one-fourth for the fourth payment technology could receive up to 4 years not available on charity care necessary year, and zero thereafter. However, of financial incentive payments. The to calculate the portion of the formula section 1886(n)(2)(E)(ii) of the Act transition factor phases down the specified in clause (ii)(II) of section provides that if ‘‘the first payment year incentive payments over the 4-year 1886(n)(2)(D) of the Act, the Secretary for an eligible hospital is after 2013, period. Therefore, an eligible hospital shall use data on uncompensated care then the transition factor specified in that is a meaningful user of certified and may adjust such data so as to be an this subparagraph for a payment year for EHR technology during the relevant appropriate proxy for charity care such hospital is the same as the amount EHR reporting period, in payment year including a downward adjustment to specified in clause (i) for such payment FY 2011, could receive incentive eliminate bad debt data from year for an eligible hospital for which payments beginning with FY 2011 uncompensated care data. In the the first payment year is 2013.’’ (transition factor equals 1), and for FY absence of the data necessary for the Accordingly, if a hospital’s first 2012 (transition factor equals three- Secretary to compute the amount payment year is FY 2014, the applicable fourths), 2013 (transition factor equals described in clause (ii)(II) of section transition factor equals three-fourths for one-half), and 2014 (transition factor 1886(n)(2)(D) of the Act, the amount the first payment year (FY 2014), one- equals one-fourth) if they continue to be under such clause shall be deemed to be half for the second payment year (FY a meaningful user of certified EHR 1. 2015), one-fourth for the third payment technology during the relevant EHR We believe that the charity care year (FY 2015, and zero thereafter.) If a reporting periods. charges reported on line 19 of the hospital’s first payment year is FY 2015, Section 1886(n)(2)(E)(ii) of the Act Worksheet S–10 represent the most the applicable transition factor equals establishes the range of time during accurate measure of charity care charges one-half for the first payment year (FY which a hospital may begin to receive as part of the hospital’s overall reporting 2015), one-fourth for the second incentive payments, and the applicable of uncompensated and indigent care for payment year (FY 2016), and zero transition periods for hospitals that are Medicare purposes. Therefore, since thereafter. As discussed in more detail permitted to begin receiving incentive eligible hospitals and CAHs are required below, under section 1886(n)(2)(E)(ii) of payments after FY 2011. Specifically, to complete the Worksheet S–10, if a the Act, the transition factor for a that section provides that if the ‘‘first hospital has not properly reported any hospital for which the first payment payment year for an eligible hospital is charity care charges on line 19, we may year is after 2015 equals zero for all after 2015, then the transition factor question the accuracy of the charges years. In other words, 2015 is the last * * * for such hospital and for such used for computing the Medicare share year for which eligible hospitals may year and subsequent year shall be 0.’’ of the incentive payments. With begin participation in the Medicare EHR This clause in effect provides that no appropriate resources, we believe the Incentive Program. incentive payments will be available to charity care data can be obtained by the Figure 1—Incentive Payment a hospital that would begin to receive MAC. This data would be used to Calculation for Subsection D Hospitals such payments after FY 2015. In other determine if the hospital’s charity care words, FY 2015 is the last FY in which criteria are appropriate, if a hospital Incentive Amount = [Initial Amount] × a hospital can begin to receive incentive should have reported charity care [Medicare Share] × [Transition payments. Taken together, sections charges, and if the reported charges are Factor] 1886(n)(2)(G)(i) and 1886(n)(2)(E)(ii) of proper. If we determine, as based on the Initial Amount = $2,000,000 + [$200 per the Act allow hospitals to begin determination of the MAC, that the discharge for the 1,150th – 23,000th receiving incentive payments during hospital did not properly report charity discharge] FYs 2011 through 2015. Section care charges on the Worksheet S–10, Medicare Share = Medicare/ 1886(n)(2)(E)(ii) of the Act also then we propose to deem the (Total*Charity Care) = [M/(T*C)] establishes the transition periods and

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factors that will be in effect for hospitals the first payment year is 2013.’’ By modified for those eligible hospitals that that begin to receive transition implication, this clause establishes that, first become meaningful users of payments during FY 2014 and 2015. As for hospitals that begin to receive certified EHR technology beginning in discussed previously, that section states incentive payments in FYs 2012 and 2014 or 2015. Such hospitals would that if ‘‘the first payment year for an 2013, the transition periods are receive payments as if they became eligible hospital is after 2013, then the equivalent to those for hospitals that meaningful EHR users beginning in transition factor specified in this begin to receive such payments in FY 2013. In other words, if a hospital were subparagraph for a payment year for 2011. An eligible hospital that is a to begin to demonstrate meaningful use such hospital is the same as the amount meaningful user of certified EHR of EHR certified technology in 2014, the technology could receive incentive specified in clause (i) for such payment transition factor used for that year payments beginning with FY 2012 year for an eligible hospital for which (2014) would be 3⁄4 instead of 1, 1⁄2 for (transition factor equals 1), and for FY the first payment year is 2013.’’ Section 1 4 2013 (transition factor equals three- the second year (2015), ⁄ for the third 1886(n)(2)(E)(ii) of the Act also fourths), FY 2014 (transition factor year (2016), and zero thereafter. establishes the transition periods that equals one-half), and FY 2015 Similarly, if a hospital were to begin will be in effect for hospitals that begin (transition factor equals one-fourth). meaningful use of certified EHR to receive transition payments during Similarly, an eligible hospital that is a technology in 2015, the transition factor FYs 2014 through 2015. That section meaningful EHR user could receive used for that year would be 1⁄2 instead states that if ‘‘the first payment year for incentive payments beginning with FY of 1, 1⁄4 for the second year (2016), and an eligible hospital is after 2013, then 2013 (transition factor equals 1), and for zero thereafter. the transition factor specified in this 3 FYs 2014 (transition factor equals ⁄4), Table 25 shows the possible years an subparagraph for a payment year for 2015 (transition factor equals 1⁄2), and eligible hospital could receive an such hospital is the same as the amount 1 2016 (transition factor equals ⁄4). incentive payment and the transition specified in clause (i) for such payment However, this section also specifically factor applicable to each year. year for an eligible hospital for which provides that the transition factor is

TABLE 25—TRANSACTION FACTOR FOR MEDICARE FFS ELIGIBLE HOSPITALS

Fiscal year that eligible hospital first receives the incentive payment Fiscal year 2011 2012 2013 2014 2015

2011 ...... 1.00 ...... 2012 ...... 0.75 1.00 ...... 2013 ...... 0.50 0.75 1.00 ...... 2014 ...... 0.25 0.50 0.75 0.75 ...... 2015 ...... 0.25 0.50 0.50 0.50 2016 ...... 0.25 0.25 0.25

We welcome comments from the ‘‘three-quarters of the percentage update reduction will receive the same, public on our discussion of these increase otherwise applicable.’’ For FY fully updated standardized amount for statutory requirements regarding the 2015 and each subsequent FY, the that year, and subsequent years, as those computation of the incentive payment reduction to three-quarters of the hospitals that were already meaningful amounts, and the issues regarding the applicable update for an eligible EHR users at the time when the update sources and timing of data for use in hospital that is not a meaningful EHR reduction went into effect (although these computations. user will be ‘‘331⁄3 percent for FY 2015, hospitals would remain subject to a 2 separate reduction for failure to report g. Incentive Payment Adjustment 66 ⁄3 percent for FY 2016, and 100 quality data under RHQDAPU). In order Effective in FY 2015 and Subsequent percent for FY 2017 and each to conform with this new update Years for Eligible Hospitals Who Are subsequent FY.’’ In other words, the reduction, section 4102(b)(1)(A) of the Not Meaningful EHR Users Secretary is required to subject eligible hospitals who are not meaningful users HITECH Act revises section In addition to providing for incentive 1886(b)(3)(B)(viii)(1) of the Act to to one-quarter, one-half, and three- payments for meaningful use of EHRs provide that, beginning with FY 2015, quarters reductions of their market during a transition period, section the reduction to the IPPS applicable basket updates in FY 2015, FY 2016, 1886(b)(3)(B) of the Act, as amended by percentage increase for failure to submit section 4102(b)(1) of the HITECH Act, and FY 2017 and subsequent years data on quality measures to the provides for an adjustment to the market respectively. Section 4102(b)(1)(B) of Secretary shall be one-quarter of the basket update to the IPPS payment rate the HITECH Act also provides that such applicable market basket update. In this for those eligible hospitals that are not ‘‘reduction shall apply only with respect way, even the combined reductions for meaningful EHR users for the EHR to the FY involved and the Secretary EHR use and quality data reporting will reporting period for a payment year, shall not take into account such not produce an update of less than zero beginning in FY 2015. Specifically, reduction in computing the applicable for a hospital in a given FY as long as section 1886(b)(3)(B) of the Act provides percentage increase * * * for a the hospital market basket remains a that, ‘‘for FY 2015 and each subsequent subsequent FY.’’ This provision positive number. FY,’’ an eligible hospital that is not ‘‘a establishes a continuing incentive for The following example illustrates meaningful EHR user * * * for an EHR hospitals to become meaningful EHR how this payment reduction would reporting period’’ will receive a reduced users, because a hospital that does work. Suppose that the market basket update to the IPPS standardized become a meaningful EHR user in any ‘‘percentage increase otherwise amount. This reduction will apply to year after the effective date of the applicable’’ to the IPPS standardized

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amount is 2.0 percent. Of this 2.0 the full 2.0 percent update minus the discussed in section II.A.2. of this percent, one-quarter (0.5 percent) of the reduction of one-quarter (0.5 percentage proposed rule. market basket update would be subject point) for failing to report quality data, a. Definition of CAHs for Medicare to a reduction for any hospital that fails and a further reduction of 1.0 to submit data on quality measures, and percentage point (662⁄3 percent of three- Section 1861(mm)(1) of the Act up to three-quarters (1.5 percent) would quarters of the full update: 2⁄3 times 1.5 defines a CAH as a facility that has been be subject to a reduction for any equals 1.0). certified as a critical access hospital hospital that is not a meaningful EHR For FYs 2017 and subsequent FYs, the under section 1820(c). CAHs are user. For FY 2015, hospitals could possibilities (assuming a 2 percent reimbursed for services furnished to receive one of four different updates, update that is otherwise applicable) are Medicare beneficiaries under section depending upon their reporting of as follows: 1814(l) of the Act for inpatient services quality data and their use of EHRs: • A hospital that reports quality data and section 1834(g) of the Act for • A hospital that reports quality data and qualifies as a meaningful EHR user outpatient services. Incentive payments and qualifies as a meaningful EHR user would receive the full update of 2.0 for CAHs under section 1814(l)(3)(A) of would receive the full update of 2.0 percent. the Act will be calculated based on the percent. • A hospital that fails to report provider number used for cost reporting • A hospital that fails to report quality data, but is a meaningful EHR purposes, which is the CCN of the main quality data but is a meaningful EHR user would receive an update of 1.5 provider. The process for making user would receive an update of 1.5 percent, which represents the full 2.0 incentive payments to CAHs is percent, which represents the full 2.0 percent update minus the reduction of discussed in section II.B.4.c. of this percent update minus the reduction of one-quarter (0.5 percentage point) for proposed rule. failing to report quality data. one-quarter (0.5 percentage point) for b. Current Medicare Payment of • A hospital that reports quality data, failing to report quality data. Reasonable Cost for CAHs • A hospital that reports quality data but does not qualify as a meaningful but does not qualify as a meaningful EHR user would receive an update of For Medicare purposes, CAHs are EHR user would receive an update of 0.5 percent, which represents the full paid for most inpatient and outpatient 1.5 percent, which represents the full 2.0 percent update minus 1.5 percentage services to Medicare beneficiaries on the 2.0 percent update minus 0.5 percentage points (100 percent of three-quarters of basis of reasonable cost under section point (331⁄3 percent of three-quarters of the full update, which equals 1.5) for 1814(l) and section 1834(g) of the Act, the full update: 1⁄3 times 1.5 equals 0.5). failing to be a meaningful EHR user. respectively. Thus, CAHs are not subject • A hospital that fails to report • A hospital that fails to report to the IPPS and Hospital Outpatient quality data and does not qualify as a quality data, and does not qualify as a Prospective Payment System (OPPS). meaningful EHR user would receive an meaningful EHR user would receive an Section 1861(v)(1)(A) of the Act is the update of 1.0 percent, which represents update of 0.0 percent, which represents statutory basis for reasonable cost the full 2.0 percent update minus the the full 2.0 percent update minus the reimbursement in Medicare. Under the reduction of one-quarter (0.5 percentage reduction of one-quarter (0.5 percentage reasonable cost reimbursement point) for failing to report quality data, point) for failing to report quality data, methodology, payments to providers are and a further reduction of 0.5 and a further reduction of 1.5 based on the reasonable cost of 1 furnishing Medicare-covered services to percentage point (33 ⁄3 percent of three- percentage points (100 percent of three- 1 beneficiaries. Reasonable cost includes quarters of the full update: ⁄3 times 1.5 quarters of the full update, which equals equals 0.5). 1.5) for failing to be a meaningful EHR all necessary and proper costs in For FY 2016, hospitals could receive user. furnishing the services, subject to the one of four different updates (assuming These examples are illustrative of principles of reasonable cost a 2 percent update that is otherwise current law. Specific proposals to reimbursement relating to certain applicable), depending upon their implement these payment adjustments specific items of revenue and cost. reporting of quality data and their use for subsection (d) hospitals that are not Reasonable cost takes into account both of EHRs: meaningful EHR users are not being direct and indirect costs of providers of • A hospital that reports quality data made at this time but will be subject to services, including normal standby and qualifies as a meaningful EHR user future rule-making prior to the 2015 costs. The objective of the reasonable would receive the full update of 2.0 implementation date. We welcome cost methodology is to ensure that the percent. comments on these payment costs for individuals covered by the • A hospital that fails to report adjustments and any comments received program are not borne by others not so quality data, but is a meaningful EHR will be considered in developing future covered, and the costs for individuals user would receive an update of 1.5 proposals to implement these not so covered are not borne by the percent, which represents the full 2.0 provisions. program. The reasonable costs of percent update minus the reduction of services and the items to be included 3. Incentive Payments for Critical one-quarter (0.5 percentage point) for are determined in accordance with the Access Hospitals (CAHs) failing to report quality data. regulations at 42 CFR part 413, manual • A hospital that reports quality data, Section 1814(l)(3)(A) of the Act, as guidance, and other CMS instructions. but does not qualify as a meaningful amended by section 4102(a)(2) of the Currently, under section 1814(l)(1) of EHR user would receive an update of HITECH Act, also provides for incentive the Act and § 413.70(a) of the 1.0 percent, which represents the full payments for CAHs that are meaningful regulations, effective for cost reporting 2.0 percent update minus 1.0 percentage users of certified EHR technology during periods beginning on or after January 1, point (662⁄3 percent of three-quarters of an EHR reporting period for a cost 2004, payment for inpatient services of the full update: 2⁄3 times 1.5 equals 1.0). reporting period beginning during a a CAH, other than services of a distinct • A hospital that fails to report payment year after FY 2010 but before part unit of a CAH, is 101 percent of the quality data, and does not qualify as a FY 2016. The criteria for being a reasonable costs of the CAH in meaningful EHR user would receive an meaningful EHR user, and the manner providing CAH services to its inpatients, update of 0.5 percent, which represents for demonstrating meaningful use, are as determined in accordance with

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section 1861(v)(1)(A) of the Act and percent (not to exceed 100 percent) equal to granted an exemption under this with the applicable principles of cost the sum of— provision for more than 5 years. reimbursement in Parts 413 and 415 of (I) the Medicare share (as would be Section 1814(l)(5) provides that there the regulations. However, payment for specified under paragraph (2)(D) of section shall be no administrative or judicial 1886(n)) for such critical access hospital if review under sections 1869 or 1878 of inpatient CAH services is not subject to such critical access hospital was treated as an the reasonable cost principles of the eligible hospital under such section; and the Act, or otherwise, of: (1) The lesser of cost or charges, the reasonable (II) 20 percentage points. methodology and standards for compensation equivalent limits for determining the amount of payment physician services to providers, the Section 1814(l)(3)(B) of the Act under section 1813(l)(3) and payment ceilings on hospital operating costs, and provides that the incentive payment for adjustments under section 1814(l)(4); (2) the payment window provisions for CAHs will be paid ‘‘through a prompt the methodology and standards for preadmission services, specified in interim payment (subject to determining a CAH to be a meaningful § 412.2(c)(5) and § 413.40(c)(2). Section reconciliation) after submission and EHR user; (3) the methodology and 1834(g) of the Act and § 413.70(b) of the review of such information (as specified standards for determining if the regulations describe the payment by the Secretary) necessary to make hardship exemption applies to a CAH; methodology for outpatient services such payment.’’ The provision also (4) the specification of EHR reporting furnished by a CAH. states that ‘‘[i]n no case may payment periods; and (5) the identification of Currently, reasonable cost under this paragraph be made with reasonable costs used to compute CAH reimbursement for CAHs includes respect to a cost reporting period incentive payments. payment for depreciation of depreciable beginning during a payment year after d. Incentive Payment Calculation for assets used in providing covered 2015 and in no case may a critical CAHs access hospital receive payment under services to beneficiaries, as described Consistent with section 1814(l)(3)(A) under Part 413 subpart G of our this paragraph with respect to more than 4 consecutive payment years.’’ of the Act, we are proposing to amend regulations and § 104 of the Medicare § 413.70(a) to add a new paragraph (5) Section 1814(l)(3)(C) of the Act Provider Reimbursement Manual (PRM). to provide for an incentive payment to provides that the reasonable costs for In general, the depreciation expense of a qualifying CAH for the reasonable which a CAH may receive an incentive an asset, representing a portion of the costs incurred for the purchase of payment are costs for the purchase of depreciable asset’s costs which is certified EHR technology in a cost certified EHR technology to which allocable to a period of operation, is reporting period beginning during a purchase depreciation (excluding determined by distributing the payment year after FY 2010 but before acquisition costs of the depreciable interest) would otherwise apply under FY 2016. We are proposing to include asset, less any salvage costs, over the section 1814(l)(1) of the Act. a cross-reference to § 495.106 which estimated useful life of the asset. Section 1814(l)(4)(A) of the Act defines the terms associated with the c. Changes Made by the HITECH Act provides for an adjustment, subject to CAH incentive payment, including the the hardship exemption in section definition of a ‘‘qualifying CAH’’ that is Sections 4102(a)(2) and 4102(b)(2) of 1814(l)(4)(C) of the Act, to a CAH’s eligible to receive the CAH incentive the HITECH Act amended section reimbursement at 101 percent of its payment, and the methodology for 1814(l) of the Act, which governs reasonable costs if the CAH has not met determining the amount of that payment for inpatient CAH services. the meaningful EHR user definition for incentive payment. In addition, we are The HITECH Act did not amend section an EHR reporting period that begins in proposing to amend § 413.70(a) to add a 1834(g) of the Act, which governs FY 2015 or a subsequent fiscal year. new paragraph (6) to provide for the payment for outpatient CAH services. Section 1814(l)(4)(B) of the Act specifies adjustment of a CAH’s reasonable costs Sections 4102(a)(2) and 4102(b)(2) of that if a CAH is not a meaningful EHR of providing inpatient services starting the HITECH Act amended section user during the cost reporting period in FY 2015 if the CAH is not a 1814(l) of the Act by adding new beginning in FY 2015, its qualifying CAH. paragraphs (3), (4), and (5) as follows: reimbursement will be reduced from In computing the CAH incentive Section 1814(l)(3)(A) of the Act provides 101 percent of its reasonable costs to payment and applying the adjustments the following: 100.66 percent. For FY 2016, the to a CAH’s payment if the CAH is not The following rules shall apply in percentage of reimbursement for a CAH a qualifying CAH, we propose to apply determining payment and reasonable costs that is not a meaningful EHR user is the definitions of certified EHR * * * for a critical access hospital that reduced to 100.33 percent of its technology, EHR reporting period, would be a meaningful EHR user (as would reasonable costs. For FY 2017 and each meaningful EHR user and qualified EHR be determined under paragraph (3) of section subsequent FY, the percentage of in proposed § 495.4 that are discussed 1886(n)) for an EHR reporting period for a reimbursement is reduced to 100 cost reporting period beginning during a elsewhere in this proposed rule. payment year if such critical access hospital percent of reasonable costs. Section In proposed § 495.106(a), we are was treated as an eligible hospital under such 1814(l)(4)(C) of the Act states that, as proposing to define a qualifying CAH as section: provided for eligible subsection (d) a CAH that meets the meaningful EHR (i) The Secretary shall compute reasonable hospitals, the Secretary may, on a case- user definition for eligible hospitals in costs by expensing such costs in a single by-case basis, exempt a CAH from this § 495.4, which is discussed in section II payment year and not depreciating these adjustment if the Secretary determines, A.1. of this proposed rule. Also in costs over a period of years (and shall subject to annual renewal, that requiring proposed § 495.106(a), for the purposes include as costs with respect to cost reporting the CAH to be a meaningful EHR user of computing the CAH incentive periods beginning during a payment year during a cost reporting period beginning payment, we are proposing that the costs from previous cost reporting periods to the extent they have not been fully in FY 2015 or a subsequent fiscal year reasonable costs for the purchase of depreciated as of the period involved). would result in a significant hardship, certified EHR technology mean the (ii) There shall be substituted for the such as in the case of a CAH in a rural reasonable acquisition costs, excluding Medicare share that would otherwise be area without sufficient Internet access. any depreciation and interest expenses applied [to CAHs under section 1814(l)(1)] a However, in no case may a CAH be associated with the acquisition,

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incurred for the purchase of depreciable methodology described in section purchase of certified EHR technology in assets as described at part 413 subpart II.A.2.b. of this proposed rule plus 20 a payment year. G, such as computers and associated percentage points). Therefore, the CAH’s Under § 495.106(d)(4), we propose hardware and software, necessary to incentive payment for FY 2012 is that an incentive payment may be made administer certified EHR technology as $360,000 ($400,000 times 90 percent). with respect to a cost reporting period defined in § 495.4 of this proposed rule. This CAH’s first payment year is FY beginning during a payment year We also propose to define payment year 2012, and it can receive incentive beginning with FY 2011 (October 1, for CAHs to mean a fiscal year payments through 4 consecutive 2010 through September 30, 2011) beginning after FY 2010 but before FY payment years which, in this example, through FY 2015 (October 1, 2014 2016. would be FYs 2012 through 2015. through September 30, 2015), but in no Under proposed § 495.106(b), we If, in the above example, the CAH also case may a CAH receive an incentive specify that a qualifying CAH shall incurred reasonable costs of $300,000 payment with respect to more than four receive an incentive payment for its for the purchase of certified EHR consecutive payment years. Therefore, a reasonable costs incurred for the technology in its cost reporting period CAH, that is a meaningful EHR user, purchase of certified EHR technology. beginning in FY 2012 that will not be may begin receiving an incentive The CAH incentive payment will be for depreciated, then the incentive payment payment for its cost reporting period a cost reporting period that begins for FY 2012 is $630,000 ($700,000 beginning in FY 2011 for the incurred during a payment year after FY 2010 but ($400,000 in FY 2011 plus $300,000 in reasonable costs for the purchase of before FY 2016. FY 2012) times 90 percent). certified EHR technology during that Consistent with section 1814(l)(3)(A) (The preceding examples are offered cost reporting period and in previous of the Act, under proposed § 495.106(c), for illustrative purposes only and are cost reporting periods to the extent that the proposed payment methodology for not intended to encompass all possible the item or items have not been fully computing the incentive payment for a computations of the CAH incentive depreciated. These incentive payments qualifying CAH for a cost reporting payment.) will continue for no more than 4 period during a payment year is equal Under proposed § 495.106(d)(1), the consecutive payment years and will not to the product of—(1) the reasonable amount of the incentive payment made be made for a cost reporting period costs incurred for the purchase of beginning during a payment year after to a qualifying CAH under this section certified EHR technology in that cost 2015. As discussed in section II.B.4. of represents the expensing and payment reporting period and any similarly this proposed rule, the CAH must of the reasonable costs of certified EHR incurred costs from previous cost submit supporting documentation for its technology computed as described reporting periods to the extent they have incurred costs of purchasing certified above in a single payment year and, as not been fully depreciated as of the cost EHR technology to its Medicare specified in § 413.70(a)(5), such reporting period involved and (2) the contractor (Fiscal Intermediary (FI)/ payment is made in lieu of any payment CAH’s Medicare share which equals the MAC). Medicare share as computed for eligible that would have been made under CAHs cannot receive an incentive hospitals including the adjustment for § 413.70(a)(1) for the reasonable costs of payment for a cost reporting period that charity care (described in sections the purchase of certified EHR begins in a payment year after FY 2015. II.A.2.b. and A.3. of this proposed rule) technology including depreciation and If the first payment year for a CAH is FY plus 20 percentage points. However, in interest expenses associated with the 2013 then the fourth consecutive no case will the resulting Medicare acquisition. The Medicare contractor payment year would be 2016. However, share for a CAH exceed 100 percent. will review the CAH’s current year and the CAH cannot be paid an incentive This percentage adjustment will be used each subsequent year’s cost report to payment for FYs 2016 and beyond. For in place of the 101 percent typically ensure that the assets associated with FY 2016 and beyond, payment to CAHs applied to a CAH’s reasonable costs the acquisition of certified EHR for the purchase of additional EHR under section 1814(l)(1) of the Act and technology are expensed in a single technology will be made under § 413.70(a) of the regulations. period and that depreciation and § 413.70(a)(1) in accordance with the For example, a CAH first requests an interest expenses associated with the reasonable cost principles, as described incentive payment for its cost reporting acquisition are not allowed. above, which would include the period beginning on January 1, 2012 Under proposed § 495.106(d)(2), the depreciation and interest cost associated which is in FY 2012. The CAH incurred amount of the incentive payment made with such purchase. reasonable costs of $500,000 for the to a qualifying CAH under this section purchase of certified EHR technology in is paid through a prompt interim e. Reduction of Reasonable Cost its previous cost reporting period payment for the applicable payment Payment in FY 2015 and Subsequent beginning on January 1, 2011. This CAH year after—(1) The CAH submits the Years for CAHs That Are Not is a meaningful user of certified EHR necessary documentation, as specified Meaningful EHR Users technology during the relevant EHR by CMS or its Medicare contractor, to Section 4102(b)(2) of the HITECH Act reporting period and thus qualifies for support the computation of the amends section 1814(l) to include an an incentive payment for FY 2012. (For incentive payment amount; and (2) CMS adjustment to a CAH’s reimbursement at illustrative purposes this example or its Medicare contractor reviews such 101 percent of its reasonable costs if the assumes no salvage value of the assets documentation and determines the CAH has not met the meaningful EHR acquired.) The CAH depreciated interim amount of the incentive user definition for an EHR reporting $100,000 of the costs of these items in payment. period that begins in FY 2015, FY 2016, the cost reporting period beginning on Under § 495.106(d)(3), the interim FY 2017, and each subsequent FY January 1, 2011. As a result, the amount incentive payment is subject to a thereafter. Consistent with this used to compute the incentive payment reconciliation process as specified by provision, under proposed § 495.106(e) will be the remaining $400,000 of CMS and the final incentive payment as and § 413.70(a)(6), if a CAH has not undepreciated costs. The CAH’s determined by CMS or its Medicare demonstrated meaningful use of Medicare share is 90 percent (its contractor is considered payment in full certified EHR technology for FY 2015, Medicare share of 70 percent using the for the reasonable costs incurred for the its reimbursement will be reduced from

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101 percent of its reasonable costs to payments to eligible professionals, carriers/MACs will issue incentive 100.66 percent. For FY 2016, its eligible hospitals, and CAHS who are payments to qualifying EPs after reimbursement will be reduced to meaningful users of certified EHR ensuring payment has not already been 100.33 percent of its reasonable costs. technology as early as FY 2011 for made under the Medicaid program for For FY 2017 and each subsequent FY, qualifying eligible hospitals and CAHs the relevant payment year. As required its reimbursement will be reduced to and CY 2011 for qualifying EPs. The by section 1848(m)(2) of the Act as 100 percent of reasonable costs. statute does not specify the process for amended by section 4101(f) of the However, as provided for eligible making these payments to qualifying HITECH Act, qualifying EPs receiving hospitals, a CAH may, on a case-by-case EPs and qualifying eligible hospitals incentive payments from the Medicare basis, be exempted from this adjustment and CAHs participating in the FFS EHR incentive payment program may if CMS or its Medicare contractor Medicare incentive payment program, not also receive an e-prescribing determines, on an annual basis, that but instead leaves the payment process incentive payment. The carriers/MACs requiring the CAH to be a meaningful to the Secretary’s discretion. will also track the incentive payment at EHR user would result in a significant We propose that FIs, carriers, and the qualifying EP’s TIN level, and hardship, such as in the case of a CAH MACs, as appropriate, would be disburse the electronic payment to the in a rural area without sufficient responsible for determining the TIN provided by the qualifying EP Internet access. However, in no case incentive payment amounts for indicated during the registration may a CAH be granted an exemption qualifying EPs and qualifying eligible process; qualifying EPs who do not have under this provision for more than 5 hospitals and CAHs in accordance with individual TINs (that is, a qualifying EP years. the proposed methodology set forth in who works solely in a group practice) Section 1814(l)(5) of the Act exempts section II.B.1.b. and B.2.b. of this will be paid at the group practice level’s the determinations made under proposed rule based on the previously TIN. Since some EPs work in multiple paragraphs (l)(3) and (l)(4) from discussed meaningful use criteria, group practices, we considered allowing administrative and judicial review. disbursing the incentive payments to these EPs to direct that their incentive Accordingly, under proposed qualifying EPs and qualifying eligible payment be allocated among the § 413.70(a)(6)(iv) and § 495.106(f), we hospitals and CAHs, and resolving any multiple practices based on individual are proposing that there shall be no reconciliation issues. and/or group TINs. However, as administrative or judicial review under a. Incentive Payments to EPs discussed more fully in section II.B.1.d sections 1869 or 1878 of the Act, or of this proposed rule, we determined otherwise, of the following: We propose that the carriers/MACs that this would create a significant • The methodology and standards for calculate incentive payment amounts administrative burden for us and determining the amount of payment for qualifying EPs. Incentive payments therefore are proposing that qualifying under section 1814(l)(3) of the Act and will be disbursed on a rolling basis, as EPs select one TIN for disbursement of payment adjustments under section soon as they ascertain that an EP has their Medicare EHR incentive payment. 1814(l)(4) of the Act for CAHs, demonstrated meaningful use for the Of course, after the payment is including selection of periods under applicable reporting period (i.e., 90 days disbursed to their designated TIN, section 1886(n)(2) of the Act for for the first year or a calendar year for qualifying EPs may decide to allocate determining, and making estimates or subsequent years), and reached the their incentive payment among the using proxies of, inpatient-bed-days, threshold for maximum payment. As multiple practices in which they furnish hospital charges, charity charges, and discussed previously in section II.A.1.b. covered professional services. subject to the Medicare share under subparagraph of this proposed rule, once a qualifying applicable laws, regulations and rules, (D) of section 1886(n)(2) of the Act; EP’s allowed charges reach the including, without limitation, those • The methodology and standards for minimum threshold of allowed charges related to fraud, waste, and abuse. determining a CAH to be a meaningful for the payment year, the qualifying EP In addition, we recognize that EHR user under section 1886(n)(3) of is eligible to receive the maximum financial relationships between the Act as would apply if the CAH was incentive payment; the carrier/MAC physicians and their employers/entities treated as an eligible hospital under would be authorized to disburse the full with which they have contractual section 1886(n) of the Act; incentive payment to that qualifying EP. arrangements may implicate certain • The methodology and standards for If a qualifying EP’s allowed charges do fraud, waste, and abuse laws, determining if the hardship exemption not reach the minimum threshold regulations, and rules. Therefore, we are under section 1814(l)(4)(C) of the Act during the payment year (including considering including specific applies to a CAH; subsequent claims submitted not later safeguards to limit the risk that the • The specification of EHR reporting than 2 months after the end of the allocation/reassignment of incentive periods under section 1886(n)(6)(B) of payment year per statute) and if the payments could raise under those and the Act as applied under section qualifying EP is also a qualifying MA other applicable laws, regulations and 1814(l)(3) and (4) of the Act for CAHs; EP, the qualifying MA organization with rules; we appreciate public comments and which the EP is affiliated will receive on this consideration. • The identification of reasonable the incentive payment for the EP from b. Incentive Payments to Eligible costs used to compute the CAH the MA. If the qualifying EP does not Hospitals incentive payment under section also qualify as a MA EP, then the 1814(l)(3)(C) of the Act. carriers/MAC will calculate the amount The FIs/MACs will calculate of the qualifying EP’s incentive payment incentive payments for qualifying 4. Process for Making Incentive an amount determined by statute as 75 eligible hospitals, and will disburse Payments Under the Medicare FFS percent of the accumulated allowed such payments on an interim basis once Program charges based on claims submitted not the hospital has demonstrated it is a As previously discussed in section later than 2 months after the end of the meaningful EHR user for the EHR II.B.1. and 2. of this proposed rule and payment year), and disburse the reporting period for the payment year. sections 1848(o)(1) and 1886(n)(1) of the incentive payment to the qualifying EP As discussed above in section B.2.b. of Act, the statute provides for incentive in the year following payment year. The the proposed rule, the formula for

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calculating a qualifying eligible d. Payment Accounting Under Medicare In § 495.202(a)(2), we propose to hospital’s incentive payment requires We will conduct selected compliance deem MA organizations offering MA the following data: (1) An initial reviews of EPs, eligible hospitals, and HMO plans that are not federally- amount; (2) the Medicare share; and (3) qualified CAHs who register for the qualified HMOs to meet the definition a transition factor applicable to that incentive programs and of recipients of of HMO in section 2791(b)(3) of the PHS Act, as HMOs recognized under State payment year. FIs/MACs will use the incentive payments for the meaningful prior-year cost report, Provider law, or as entities subject to State use of certified EHR technology. The Statistical and Reimbursement (PS&R) solvency rules in the same manner as reviews will validate provider eligibility System data, and other estimates to HMOs. We believe this is reasonable and their meaningful use attestations calculate the interim incentive payment. because under the MA application including verification of meaningful use As discussed in section II.B.2.c. of this process, State regulators are required to and would also review components of proposed rule, beginning in 2010, cost certify that MA organizations operating the payment formulas. reports will capture charity care data in their State are authorized to offer the We will identify and recoup which will be used in calculating the type of MA plan they propose to offer, overpayments made under the incentive Medicare share of the payment. As and meet solvency standards that are payment programs that result from discussed in section II.B.2.b. of this adequate for these purposes. For each proposed rule, we are proposing to incorrect or fraudulent attestations, MA organization offering MA HMO calculate a qualifying hospital’s final quality measures, cost data, patient data, plans, the State has thus recognized that incentive payment using data from the or any other submission required to the organization is able to assume risk cost report for the hospital’s fiscal year establish eligibility or to qualify for a as an HMO. Therefore, we have that ends during the FY prior to the FY payment. The overpayment will be determined that absent evidence to the that serves as the payment year. We recouped by CMS or its agents from the contrary, an MA organization offering therefore are proposing that the FIs/ EP, eligible hospital, MA organization, HMO plans is recognized by the State as MACs calculate the final incentive CAH, other entities to whom the right to a health maintenance organization, or payment using actual cost report data payment has been assigned/reassigned, that it is subject to State solvency report for the hospital’s fiscal year that or, in the case of Medicaid, from the standards in the same manner and to the ends during the FY prior to the fiscal State Medicaid agencies. Medicare FFS same extent as an HMO and therefore year that serves as the payment year, EPs and eligible hospitals will need to provides sufficient assurance that the and will reconcile the incentive maintain evidence of qualification to section 2791(b)(3) of the PHS Act payment as necessary at settlement of receive incentive payments for 10 years definition is met. the cost report. Incentive payments for after the date they register for the In proposed § 495.202(a)(3), for MA qualifying eligible hospitals will be incentive program. organizations that offer other calculated based on the provider C. Medicare Advantage (MA) coordinated care MA plans (Preferred number used for cost reporting Organization Incentive Payments Provider Organization (PPO) plans, purposes, which is the CCN of the main Provider Sponsored Organization (PSO) provider. Therefore, the FIs/MACs 1. Definitions plans, and Regional Preferred Provider would disburse incentive payments to a. Qualifying MA Organization Organization (RPPO) plans) and for qualifying hospitals based on the CCN other MA organizations offering other rather than the TIN. Section 1853(l)(1) of the Act, as added MA plan types (private fee-for-service by section 4101(c) of the HITECH Act, (PFFS) plans, Medical Savings Account c. Incentive Payments to CAHs provides for incentive payments to (MSA) plans), we would require the CAHs are paid on a cost qualifying MA organizations for certain sponsoring MA organization to attest reimbursement basis; once a CAH incurs of their affiliated EPs who are that the MA organization is recognized actual EHR costs, it can submit meaningful users of certified EHR under State law as an HMO, or that it supporting documentation to the FI/ technology during the relevant EHR is a similar organization regulated under MAC for review. The FIs/MACs will reporting period for a payment year. State law for solvency in the same determine an incentive payment Section 1853(l)(5) of the Act defines the manner and to the same extent as an amount, as previously discussed in term ‘‘qualifying MA organization’’ as an HMO before we would make a section II.A.3. of this proposed rule by MA organization that is organized as a determination that the MA organization substituting for the Medicare share health maintenance organization (HMO) is a qualifying MA organization for amount that would otherwise be applied as defined in section 2791(b)(3) of the purposes of incentive payments. under the formula used for computing PHS Act. Section 2791(b)(3) of the PHS payments for eligible hospitals, a Act in turn defines a health b. Qualifying MA Eligible Professional percent (not to exceed 100 percent) maintenance organization as a federally (EP) equal to the sum of—(1) The Medicare qualified HMO, an organization A qualifying MA organization may share for such CAH, and (2) 20 recognized as an HMO under State law, receive an incentive payment only for percentage points. or a similar organization regulated for those EPs described under section The FIs/MACs will reconcile the cost solvency under State law in the same 1853(l)(2) of the Act, as added by report and ensure the EHR expenses are manner and to the same extent as an section 4101(c) of the HITECH Act. adjusted on the cost report to avoid HMO. Since there are few federally Section 1853(l)(2) of the Act provides duplicate payments. Incentive payments qualified HMOs, we expect MA that these EPs must be ‘‘eligible for qualifying CAHs will be calculated organizations to primarily qualify for professionals’’ as defined under section based on the provider number used for incentive payments as State-licensed 1848(o) of the Act as added by section cost reporting purposes, which is the HMOs, or as organizations regulated for 4101(a) of the HITECH Act, and must CCN number of the main provider. solvency under State law in the same either— Therefore, the FIs/MACs will disburse manner and to the same extent as • Be employed by the qualifying MA incentive payments to qualifying CAHs HMOs. Therefore, in § 495.200 we organization; or based on the CCN number rather than propose to define ‘‘qualifying MA • Be employed by, or be a partner of, the TIN. organization.’’ an entity that through contract with the

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qualifying MA organization furnishes at average, at least 20 hours per week of potentially entitled to an incentive least 80 percent of the entity’s Medicare patient care services, we interpret the payment either through the Medicare patient care services to enrollees of the requirement to include both Medicare FFS incentive program, or through the qualifying MA organization. and non-Medicare patient care services. MA-affiliated hospital EHR incentive Further, the EP must furnish at least Moreover, we propose that the relevant program. Therefore, for such a hospital- 80 percent of his or her professional time period for determining whether an based MA EP, a qualifying MA services covered under Title XVIII MA EP furnishes at least 20 hours per organization would be no more entitled (Medicare) to enrollees of the qualifying week of patient care services should be to an MA EP incentive payment under MA organization and must furnish, on the EHR reporting period. (We discuss the MA EHR incentive program than a average, at least 20 hours per week of the proposed definition of EHR similarly situated EP would be entitled patient care services. reporting period in section II.A. 1. e. of to an incentive payment under the As discussed in section II.A.1. of this this proposed rule.) Therefore, over the Medicare FFS EHR incentive program. proposed rule, an EP is defined as a EHR reporting period, the qualifying EP physician (under section 1861(r) of the must provide on average 20 hours per As discussed previously, an MA EP Act). week of patient care services. Finally, must either be employed by the We interpret ‘‘employed by’’ to mean we interpret ‘‘patient care services’’ to qualifying MA organization, or be that the EP is considered an employee mean services that would be considered employed by, or be a partner of, an of a qualifying MA organization or ‘‘covered professional services’’ under entity that through contract with the qualifying entity under the usual sections 1848(o)(5)(A) and (k)(3) of the qualifying MA organization furnishes at common law rules applicable in Act. That is, health care services for least 80 percent of the entity’s Medicare determining the employer-employee which payment would be made under, patient care services to enrollees of the relationship under section 3121(d)(2) of or for which payment would be based qualifying MA organization. With the Internal Revenue Code of 1986. on, the fee schedule established under respect to the later criteria, we do not We interpret ‘‘to be a partner of’’ to Medicare Part B if they were furnished propose to define the term ‘‘entity,’’ but mean that the qualifying MA EP has an by an eligible professional. instead recognize that there exist a range ownership stake in the entity. Under We considered various methods of of entities with which MA organizations this proposed interpretation, a determining when at least 20 hours per contract for patient care services, professional that contracts with an week, on average, of patient care including a physician group, an entity, but has no ownership stake in services will be considered to be Independent Practice Association (IPA), the entity, would not be considered a provided by MA EPs. We considered an Exclusive Provider Organization qualifying MA EP. methods such as defining a dollar or (EPO), a Physician Hospital We interpret ‘‘furnishing at least 80 service threshold, or the number of Organization (PHO), or Preferred percent’’ of the entity’s ‘‘patient care hours of direct patient care services Provider Organization (PPO). services’’ to mean at least 80 percent of actually provided. After due the qualifying MA EP’s total Medicare consideration we propose to require Moreover, we recognize that an EP revenue in a year (that is, total revenue qualifying MA organizations to attest to may contract with more than one such from Medicare FFS as well as from all the fact that MA EPs for whom they are entity, and that these entities often MA organizations) must be from a single requesting EHR incentive payments contract with a number of MA qualifying MA organization. have provided, on average, 20 hours of organizations and other health care We propose to interpret the patient care services during the EHR insurers. An EP also may directly requirement that a qualifying MA EP reporting period. contract with more than one MA furnish at least 80 percent of their As discussed in section II.B. of this organization. In general it is only when professional services covered under proposed rule relating to Medicare FFS an EP is employed by a single qualifying Title XVIII means that at least 80 EPs, a qualifying MA EP is also defined MA organization, or is employed by or percent of the professional’s total as a physician under section 1861(r) of in partnership with an entity that Medicare revenue in a year (that is, total the Act. Section 1853(l)(1) of the Act, as contracts with a single qualifying MA revenue from Medicare FFS as well as added by section 4101(c) of the HITECH organization that an EP can satisfy the from all MA organizations) must be Act, provides that the provisions of criteria to be an MA EP. from a single qualifying MA sections 1848(o) and 1848(a)(7) of the Finally, the qualifying MA organization. We believe that in Act, as amended and added by sections organization must attest to the fact that establishing the rule that qualifying MA 4101(a) and (b) of the HITECH Act, each MA EP is a meaningful user of EPs need to furnish at least 80 percent respectively, which establish the certified EHR technology in accordance of the EP’s Title XVIII covered services incentive payments for EPs under with proposed § 495.4. If all of these ‘‘to enrollees of the organization,’’ the Medicare FFS, apply to a qualifying MA conditions are met, such an individual statute limits payment related to any ‘‘ organization’s qualifying MA EPs in a is identified as an MA EP. We propose specific qualifying MA EP to a single similar manner’’ as they apply to EPs to define the term ‘‘MA eligible qualifying MA organization. Thus, if a under Medicare FFS. As discussed professional (EP)’’ at § 495.200 as an EP qualifying MA EP provided an average above in section II.A.6. of this proposed who satisfies these conditions. of 20 hours per week of patient care rule, section 1848(o)(1)(C)(i) of the Act, services to two distinct qualifying MA as added by section 4101(a) of the Section 4101(d) of the HITECH Act organizations, we would pay the HITECH Act, states that hospital-based directs the Secretary to study and report qualifying MA organization for the MA EPs are not eligible for incentive on ‘‘nearly exclusive’’ physicians that EP only if such a qualifying EP provided payments. Therefore, we propose that, primarily treat MA enrollees and that at least 80 percent of his or her similar to the Medicare FFS incentive would not otherwise qualify for professional services covered under program, MA incentive payments would incentive payments under current law. Title XVIII to enrollees of that also not be available for hospital-based This proposed rule does not address organization. EPs. We note that the hospital where a such individuals, as it is limited to For purposes of determining whether hospital-based EP provides his or her codifying in regulation existing a qualifying MA EP furnishes, on Medicare covered services would be statutory language as discussed herein.

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c. Qualifying MA-Affiliated Eligible attributable to individuals enrolled in We also propose requiring qualifying Hospital MA plans under Part C. This means that MA organizations, as part of their initial We propose to define ‘‘qualifying MA- hospitals that treat individuals enrolled bids starting with plan year 2011, to affiliated eligible hospital’’ in § 495.200. in MA plans will receive a Medicare make a preliminary identification of A qualifying MA organization may FFS hospital incentive payment potentially qualifying MA EPs and receive an incentive payment only for a partially based on the number of MA- potentially qualifying MA-affiliated qualifying MA-affiliated eligible enrollee bed-days. To the extent a eligible hospitals for which the hospital described under section hospital does not meet the 33 percent organizations will seek EHR incentive 1853(m)(2) of the Act, as added by threshold requiring payment through payments. In developing the preliminary and section 4102(c) of the HITECH Act, that the FFS Medicare EHR hospital incentive program, incentive payments final lists of potentially qualifying MA is a meaningful user of certified EHR can be made to a qualifying MA EPs, qualifying MA organizations must technology as defined in proposed organization under common corporate exclude hospital-based MA EPs. We § 495.4 . Section 1853(m)(2) of the Act governance to the extent other propose that qualifying MA provides that such MA-affiliated eligible requirements of the MA EHR hospital organizations identify hospital-based hospitals are ‘‘eligible hospitals’’ as incentive program are met. (See section MA EPs using the same criteria outlined defined under section 1886(n)(6) of the II.C.3 of this proposed rule for the in section II.A.6 of this proposed rule Act and must be under common computation of incentive payments to for identifying hospital-based EPs in the corporate governance with a qualifying qualifying MA organizations.) Medicare FFS EHR incentive program. MA organization that serves individuals Therefore, we propose to make EHR Along with both the preliminary and enrolled under MA plans offered by incentive payments to qualifying MA- final lists of potentially qualifying MA such organization where more than two- affiliated eligible hospitals under the EPs and hospitals, qualifying MA thirds are Medicare individuals enrolled FFS EHR incentive program. Finally, to organizations must submit an attestation under MA plans offered by such the extent that such data necessary to that these professionals and hospitals organization. As discussed in section estimate the inpatient-bed-days-related meet the criteria to be considered II.A.1. of this proposed rule, section incentive payment amount are not eligible. For example, for hospitals, the 1886(n)(6) of the Act, defines an already available to us through the qualifying MA organization must attest ‘‘eligible hospital’’ as a subsection (d) normal submission of hospital cost that they are under common corporate hospital (as defined under section reports, we propose to require that governance with the qualifying MA 1886(d)(1)(B) of the Act). In § 495.200, qualifying MA organizations seeking organization. For example, for EPs, the we also propose to define ‘‘under reimbursement for qualifying MA- qualifying MA organization must attest common corporate governance’’, as a affiliated eligible hospitals submit that the list does not include any qualifying MA organization and a similar data. hospital-based EPs. qualifying MA-affiliated eligible We propose requiring qualifying MA hospital that have a common parent 2. Identification of Qualifying MA organizations to provide final corporation, that one is a subsidiary of Organizations, MA EPs, and MA- identification of potentially qualifying the other, or that the organization and Affiliated Eligible Hospitals MA EPs by the end of the MA EP the hospital have a common board of In § 495.202 we propose to require payment year (December 31), and final directors. MA organizations that intend to ask for identification of potentially qualifying Section 1853(m)(3)(B)(i) of the Act, as reimbursement under the MA EHR MA-affiliated eligible hospitals by the added by section 4101(c) of the HITECH incentive payment program to so end of the MA-affiliated hospital Act, provides that if for a payment year indicate as part of submissions of their payment year (the FFY ending on at least one-third (33 percent) of a MA initial bid under section 1854(a)(1)(A) of September 30), for which MA EHR eligible hospital’s discharges (or bed- the Act, and to attest, in some cases, that incentive payments will be sought. We days) of Medicare patients are covered they meet the requirements of a also propose requiring qualifying MA under Part A (rather than under Part C), qualifying MA organization. For MA organizations to report the name, the hospital may only receive an organizations offering an MA HMO plan practice address, and other identifying incentive payment under section type, we will deem such organizations information, like NPI, for all physicians 1886(n) of the Act—the Medicare FFS to meet the definition of HMO in 42 that meet the requirements of a incentive program. U.S.C. 300–gg(b)(3), (that is, section qualifying MA EP for which the In § 495.200 we propose to define 2791(b)(3) of the PHS Act). As noted qualifying MA organization will be ‘‘inpatient-bed-days’’ in the same previously, for MA organizations requesting payment under the MA EHR manner as that term is defined for offering plan types other than HMOs, incentive payment program. purposes of implementing section we propose to require an attestation by Once a qualifying MA organization 4201(a) of the HITECH Act in the the organization that the MA identifies potential EPs, we are required preamble of this proposed rule. The organization is recognized under State to ensure that such EPs did not receive term will be used in the same way in law as an HMO, or that it is a similar the maximum EHR incentive payment computing incentive payments due organization regulated under State law for the relevant payment year under the qualifying MA organization under the for solvency in the same manner and to Medicare FFS program under section qualifying MA-affiliated eligible the same extent as an HMO before we 1848(o)(1)(A) of the Act, as added by hospital incentive payment program. would make a determination that the section 4101(a) of the HITECH Act, We note that, as discussed in section MA organization is a qualifying MA before releasing an incentive payment to II.B.2.b. of this proposed rule, under organization for purposes of incentive a qualifying MA organization related to section 1886(n)(2)(D)(i)(II) of the Act, payments. We propose to require this such EP. (See section 1853(l)(3)(B)(i) of the portion of the Medicare FFS hospital beginning with bids due in June 2010 the Act, as added by section 4101(c) of incentive payment comprising the (for plan year 2011) for MA the HITECH Act). Therefore, in order to discharge related amount, or Medicare organizations seeking reimbursement for allow us time to determine whether an share, is based in part on the estimated MA EPs and MA-affiliated eligible MA EP received the maximum EHR number of inpatient-bed-days hospitals. incentive payment under the Medicare

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FFS program, we propose not to make would be payable if payment for • For the EP’s first payment year, incentive payments to qualifying MA services furnished by such hospitals $15,000 (or, if the first payment year is organizations for the MA EPs for a was payable under Part A instead of Part 2011 or 2012, $18,000). payment year until after the final C. (For more detailed information see • For the EP’s second payment year, computation of EP incentive payments section II.B.2. of this proposed rule.) $12,000. • For the EP’s third payment year, for that year under the Medicare FFS Section 1848(o) of the Act permits us program. Additionally, we propose to $8,000. to make the incentive payments for a • For the EP’s fourth payment year, require qualifying MA organization to year in installments, although we are ensure that all MA EPs are enumerated $4,000. proposing to make a single lump sum • through the NPI system, in order to For the EP’s fifth payment year, payment under the Medicare FFS EHR detect and prevent duplicate payment $2,000. incentive program. We read the term • for EPs under both the FFS and MA For any succeeding year, $0. ‘‘aggregate’’ to mean the aggregate EHR incentive payment programs. Note that, similar to the Medicare FFS We also propose to require all installment payments made by us under EHR incentive program, there will be no qualifying MA organizations to self- the FFS EHR incentive program to a incentive payments made with respect report and identify themselves, qualifying EP over the course of the to a year after 2016. We propose similar regardless of whether they have relevant payment year. restrictions related to qualifying MA qualifying MA EPs or MA-affiliated The duplicate payment provisions in organizations. So, the maximum eligible hospitals for whom or which the section 1853(l)(3)(B)(i)(II) of the Act cumulative incentive payment over 5 organization plans to claim incentive direct us to make payment for EPs ‘‘only years to a qualifying MA organization payments at the time the initial bid is under’’ the MA EHR incentive program for each of its qualifying MA EPs that meaningfully use certified EHRs due (the first Monday of June, see ‘‘and not under’’ the Medicare FFS EHR beginning on or before 2012 would be section 1854(a)(1)(A) of the Act) incentive program to the extent any EP $44,000 per qualifying MA EP. For beginning in 2014 for bids related to has earned ‘‘less than [the] maximum qualifying MA organizations first plan year 2015. We propose to require incentive payment for the same period’’ reporting the meaningful use of certified this reporting by all qualifying MA under the Medicare FFS EHR incentive EHRs by qualifying MA EPs after 2014, organizations in years beginning with program. We note that section 1853(l)(1) there is no incentive payment amount 2014 in anticipation of the statutory of the Act, provides that section 1848(o) available. Subject to an exception requirement in sections 1853(l)(4) and of the Act applies in a ‘‘similar,’’ but not discussed below, for MA organizations 1853(m)(4) of the Act, to negatively the same, manner to qualifying MA first reporting the meaningful use of adjust our capitation payments to organizations as it applies to EPs under certified EHRs by qualifying MA EPs in qualifying MA organizations for MA EPs Part B. The Medicare FFS incentive 2013 or 2014, the maximum potential and MA-affiliated eligible hospitals that payment program under section 1848(o) incentive payment per qualifying EP is, are not meaningful users of certified does not include payment for respectively, $39,000 over 4 years, and EHR technology for years beginning professional services provided to MA with 2015. $24,000 over 3 years. enrollees, but only for services paid As we discuss in more detail in the 3. Computation of Incentives to under Part B. In a similar manner we section II.C.4. of this proposed rule, we Qualifying MA Organizations for MA propose to limit payment to an MA propose to make MA EP incentive EPs and Hospitals organization to only payment for their payments to qualifying MA EPs’ services to MA enrollees of plans In § 495.204, we propose a organizations on the same payment offered by the MA organization. We do methodology under which payments to cycle for all employed/partnering not believe it would be appropriate to qualifying MA organizations for qualifying EPs of the organization. In provide an incentive payment to an MA qualifying MA EPs will be computed. other words, all MA EPs of a specific Section 1853(l)(3)(A) of the Act provides organization for services provided to qualifying MA organization will be in that in applying section 1848(o), instead individuals covered under Part B. the same payment year with respect to of the additional payment amount Therefore, we propose, that in the amount of the incentive payment specified under section 1848(o)(1)(A) of calculating qualifying MA EP incentive per qualifying EP that we will make. So, the Act, the Secretary may substitute an payments, we will only consider for instance, if a qualifying MA amount determined by the Secretary, to covered professional services provided organization is in its second payment the extent feasible and practical, to be to enrollees of MA plans offered by year in 2013 and it hires a new EP for similar to the estimated amount in the qualifying MA organizations and will which the qualifying MA organization aggregate that would be payable under, not include in the calculation any had not previously received an EHR or would be based on, the Medicare services reimbursed by Medicare FFS. incentive payment, we will nevertheless physician fee schedule under Part B Under the Medicare FFS EHR make a second year incentive payment instead of Part C. Section II.B.1. of this incentive program, an EP’s incentive (up to $12,000 in 2013) with respect to proposed rule discusses these payment may not exceed the annual such an MA EP—assuming all other provisions. limits specified under section conditions are met. Thus, the limits on Section 1853(m)(3)(A) of the Act 1848(o)(1)(B)(i) of the Act. We propose MA EP incentive payments discussed provides that in providing an incentive that similar payment limits apply to above are applied to the qualifying MA payment to qualifying MA organizations qualifying MA organizations for their organization’s entire MA EP population for MA-affiliated hospitals, we qualifying MA EPs. Specifically, the in any specific payment year relative to substitute for the amount specified incentive payment to a qualifying MA that MA organization, regardless of the under section 1886(n)(2) of the Act—the organization for each of its qualifying length of employment/partnership of/ incentive payment amount under MA EPs may not exceed certain limits. between that specific MA EP and that Medicare FFS for qualifying eligible Specifically, section 1848(o)(1)(B) of the specific qualifying MA organization. hospitals—an amount determined by Act provides that the incentive payment Under section 1848(o)(1)(B)(iv) of the the Secretary to be similar to the for an EP for a given year shall not Act, the annual incentive payment limit estimated amount in the aggregate that exceed the following amounts: for EPs who predominantly furnish Part

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B services in a geographic health Such an EP would potentially qualify care hours spent with MA enrollees of professional shortage area (HPSA) is for the maximum Medicare FFS EP the organization or another reasonable increased by 10 percent. While we do incentive payment in the first year method. So, for instance, if a qualifying not anticipate that MA EPs would based on a calculation of $63 * 10 * 52 MA EP spends 30 percent of his or her generally practice in a HPSA area, to the = $32,760—which is more than the time providing covered Part B physician extent that an MA EP practices in an Medicare FFS EHR incentive program office services to MA plan enrollees, area where he or she would be entitled threshold of $24,000 necessary to then the qualifying MA organization to the 10 percent increase, that amount qualify for the maximum incentive would report 30 percent of the would apply to MA EPs as well. We payment of $18,000 if the fist payment qualifying MA EP’s salary as annual explored various ways of computing the year were 2011 or 2012. revenue, which would be used to EP-level incentive payments due We estimated the national average compute the amount of the MA qualifying MA organizations whose FFS allowed amounts for the 5 levels of incentive payment due to the qualifying qualifying MA EPs meaningfully use office visit codes (CPT codes 99211– MA organization for the qualifying MA certified EHR technology. 99215) in 2009 to be: $20, $39, $63, $95, EP. Thus, if the qualifying MA EP had One option that we considered was $129, respectively. We contemplated a base salary of $150,000, 30 percent using MA plan bidding and MA allowing, but not requiring, qualifying would be $45,000—which is well over payment data to estimate average annual MA organizations to report consultation the threshold of $24,000 needed by the MA revenue for qualifying MA EPs with codes for specialist physicians (CPT MA organization to qualify for a respect to a qualifying MA organization. codes 99241–99245) estimated to have maximum incentive payment of up to So, for instance, a qualifying MA national average FFS allowed amounts $18,000 (70 percent of $24,000) for such organization that estimated MA Part B of $50, $94, $129, $190, and $234, a qualifying MA EP in any year. We also service-related physician costs of $3 respectively. propose to require that salaries be million/year in its bid for a year, and However, we now believe that such a prorated to ensure that the amount that employed 100 qualifying MA process would be administratively reported reflects the salary paid for the eligible physicians, would be assumed burdensome and difficult to applicable year. to have an average physician Part B operationalize. Therefore, we are Salaried physicians’ compensation charge per physician per year factor of proposing an alternative approach, but typically does not include an allowance $30,000 ($3,000,000/100). However, we seek input from interested parties as to for administrative practice costs. Given did not pursue this option because the which of these approaches, or perhaps that Part B allowed amounts do include approach results in an average revenue others, would best address the statutory practice expense costs, we propose amount across all potentially qualifying requirement to compensate qualifying allowing qualifying MA organizations to MA EPs with respect to a qualifying MA MA organizations for qualifying MA EPs identify, where appropriate, an organization and, therefore, would the amount that would be payable if additional amount related to overhead include revenue amounts that exceed payment for services furnished by such that would be added to the qualifying the annual per-professional ceiling on professionals were made under Part B MA EP’s estimated Part B incentive payments under FFS for all instead of Part C. compensation. To the extent Medicare EPs. We believe such a result is contrary We propose an approach in which the FFS compensation to physicians to the legal requirement that qualifying revenue received by the qualifying MA includes an amount for office space MA organizations are to incentive EP for services provided to enrollees of rental, office staffing, and equipment, payments only for qualifying MA EPs the qualifying MA organization would we believe that qualifying MA that actually provide at least 20 hours serve as a proxy for the amount that organizations should also be permitted per week of patient care services. Under would have been paid if the services to include an amount for overhead this method there would also be no way were payable under Part B. Under this related to such costs not directly to know if the EP provided 80 percent approach, the qualifying MA experienced by salaried qualifying MA of his/her professional Medicare organization would report to us the EPs. In § 495.204(b)(4)(ii), we propose services to enrollees of the organization. aggregate annual amount of revenue requiring qualifying MA organizations We also considered a reporting system received by each qualifying MA EP for to develop a methodology for estimating for which qualifying MA organizations MA plan enrollees of the MA the additional amount related to would be required to report eligible- organization. We would calculate the overhead attributable to providing professional-specific information along incentive payment amount due the services that would otherwise be with MA patient encounters for qualifying MA organization for each covered under Part B of Medicare. The nonhospital-based office visits. qualifying MA EP as an amount equal to methodology would require review and Specifically, we examined requiring 75 percent of the reported annual MA approval by us. qualifying MA organizations to report revenue of the qualifying MA EP, up to For qualifying MA EPs who are not qualifying MA EP encounters with MA the maximum amounts specified under salaried (that is, who are paid on a plan enrollees based on the five levels section 1848(o)(1)(B) of the Act. capitated or fee-for-service basis), we of office visit codes recognized by For qualifying MA EPs who are propose in § 495.204(b)(5) to require Medicare FFS. compensated on a salaried basis, we qualifying MA organizations to obtain We would use such reports to propose requiring the qualifying MA attestations from such EPs and to submit estimate the amount of compensation organization to develop a methodology to CMS information from the that a qualifying MA EP working for estimating the portion of the attestations as to the amount of primarily for a qualifying MA qualifying MA EP’s salary attributable to compensation received by the EPs for organization would be eligible to receive providing services that would otherwise MA plan enrollees of the MA under Medicare FFS. For example, a be covered as professional services organization. We are proposing such qualifying MA EP with a primary care under Part B of Medicare to MA plan attestations because many EPs are not specialty might have an average of 10 enrollees of the MA organization. The paid directly by MA organizations, but MA patient low/moderate intensity methodology, which would require rather by intermediary contracting office visits with members of a review and approval by us, could be entities, such as physician groups, and qualifying MA organization per day. based on the relative share of patient as a result the qualifying MA

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organization may not otherwise know The formula for calculating the prohibition on reimbursing a qualifying how much compensation is received by hospital incentive payment under the MA-affiliated eligible hospital through each qualifying MA EP. In reporting Medicare FFS hospital incentive the Medicare FFS EHR incentive compensation, we are proposing that the program is an initial amount of the sum program, for purposes of administrative EPs include only those amounts for of the base amount of $2,000,000 per efficiency, and pursuant to our authority professional services that would hospital plus an additional $200 per under section 1857(e) of the Act to add otherwise be payable under Part B and discharge for discharges 1,150 through new ‘‘appropriate’’ contract terms for which payment would be made 23,000 for that hospital in that payment (incorporated for Part D by section under, or would be based on, the year. This initial amount is then 1860D–12(b)(3)(D) of the Act), we Medicare physician fee schedule. multiplied by a transition factor and propose requiring that qualifying MA As mentioned previously, in applying then again by the Medicare share. These organizations receive incentive the instruction in section 1853(m)(3)(A) last two numbers are fractions and will payments for qualifying MA-affiliated of the Act to substitute for the amount tend to reduce the initial amount eligible hospitals through their affiliated specified under section 1886(n)(2) of the computed in the first step. hospitals under the Medicare FFS EHR Act an amount similar to the estimated Similar to the Medicare FFS EHR incentive program if they are eligible for amount in the aggregate that would be hospital incentive program, we propose such payments, rather than through the payable if payment for the hospitals’ to use inpatient-bed-day data, MA EHR incentive program. We believe services were made under Part A discharges, and other components of the this is the most efficient way in which instead of Part C, we read the term FFS calculation for each qualifying MA- to administer the MA EHR hospital ‘‘aggregate’’ to mean the aggregate affiliated eligible hospital from the incentive program in light of the installment payments made by us if hospital-specific fiscal year that ends expected low volume of MA-affiliated EHR incentive payments were made during the FFY prior to the FFY that eligible hospitals (approximately 50 under Part A instead of Part C. serves as the payment year. To the hospitals), and in light of preliminary Incentive payments to eligible extent such data are not already data which indicates that MA-affiliated hospitals under the Medicare FFS EHR available to us through the normal eligible hospitals already submit incentive program are comprised of submission of hospital cost reporting Medicare cost reporting data to us from three components: (1) An initial amount data, we propose requiring qualifying which we can compute hospital composed of a base incentive payment MA organizations seeking incentive payments due. To the extent of $2,000,000 and a second incentive reimbursement for their qualifying MA- sufficient data do not exist to make such payment amount of $200 per discharge affiliated eligible hospitals to submit payments under the Medicare FFS EHR for discharges 1,150–23,000 during a 12- similar data. incentive program, qualifying MA month period selected by the Secretary; We can only pay for qualifying MA- organizations will be required to submit (2) the Medicare share; and (3) a affiliated eligible hospitals under additional data to us. transition factor. As discussed in the common corporate governance based on Finally, to the extent payments are preamble related to proposed inpatient-bed-days computed on a fiscal made to qualifying MA organizations for § 495.104(c), for purposes of calculating year basis where less than one-third of qualifying MA EPs or qualifying MA- incentive payments to eligible hospitals the inpatient-bed-days of Medicare affiliated eligible hospitals, we propose under the Medicare FFS EHR incentive patients are covered under Medicare to conduct selected compliance reviews program, we are proposing that the 12- FFS—Part A. However, it does not to ensure that EPs and eligible hospitals month period be based on the FFY. For appear that reimbursement only under for which such organizations received the purpose of calculating incentive the MA EHR incentive program is incentive payments were actually payments for qualifying MA-affiliated required for qualifying MA-affiliated meaningful users of certified EHR eligible hospitals, we similarly are eligible hospitals that are under technology, in accordance with our proposing that the 12-month period be common corporate governance. Rather, existing authority in section 1857(d) of based on the FFY. section 1853(m)(3)(B), of the Act only the Act and 42 CFR 422.504 of the Section II.B. of this proposed rule prohibits payment under the MA EHR regulations related to protections against discusses our proposed methodology for incentive program when Medicare fraud. The reviews would include calculating the incentive payment for hospital inpatient-bed-days covered validation of meaningful user qualifying eligible hospitals under the under Part A exceed 33 percent of all attestations, the status of the Medicare FFS EHR program. As set forth Medicare inpatient-bed-days. Although organization as a qualifying MA in proposed § 495.204(c)(2), we propose eligibility under the MA EHR hospital organization, and verification of both to use the FFS EHR hospital incentive incentive program is not available to meaningful use and data used to program for purposes of calculating and qualifying MA organizations for any calculate incentive payments. We making the incentive payment for specific hospital when FFS inpatient- propose requiring MA organizations to qualifying MA-affiliated hospitals. To bed-days exceed 33 percent of the maintain evidence of compliance with the extent data are not available to Medicare total, a qualifying MA all aspects of the MA EHR incentive reimburse MA-affiliated hospitals organization could be reimbursed payment program for 10 years after the through the FFS hospital incentive through the Medicare FFS EHR hospital date payment is made with respect to a program, we propose to require incentive payment program for given payment year. Payments that submission of such data to us and adopt qualifying hospitals under common result from incorrect or fraudulent the same definition of ‘‘inpatient-bed- corporate governance even for hospitals attestations, cost data, or any other days’’ and other terms proposed under with very low ratios of FFS to MA submission required to establish the Medicare FFS EHR hospital inpatient-bed days. eligibility or to qualify for a payment, incentive program specified in § 495.104 Given that the hospital incentive will be recouped by CMS from the MA of this proposed rule. In such a case we payment methodology and payment organization. propose in § 495.204(c)(1) to make amount will be identical under the payment for such MA-affiliated eligible Medicare FFS EHR incentive program 4. Timeframe for Payment hospitals to the qualifying MA and the MA EHR incentive program, For payments to qualifying MA EPs, organization. and given that there is no statutory in § 495.206 we propose the time frame

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for payment to be after the Medicare or up to $12,000, if its first payment program—such incentive payment will FFS program computes incentive year is 2014. Note that, similar to the only be made under the Medicare FFS payments due under the Medicare FFS Medicare FFS EHR incentive program, EHR incentive program. Therefore, EHR incentive program—so the first there would be no incentive payments before payments can be made to possible incentive payments would be made with respect to a year after 2016. qualifying MA organizations for MA made sometime in early 2012. We We propose to define ‘‘payment year’’ EPs, we must first determine if a propose that payments for qualifying with respect to qualifying MA-affiliated maximum incentive payment under the MA-affiliated eligible hospitals under eligible hospitals in § 495.200. For Medicare FFS program has been common corporate governance occur in incentive payments for qualifying MA- previously earned by potential MA EPs. the same manner and in the same time affiliated eligible hospitals, the first year Under the Medicare FFS incentive frame as payments made under the for which an MA organization may payment program, incentive payment Medicare FFS EHR incentive program to claim payment is FY 2011. Similar to calculations will not be completed for ‘‘subsection (d)’’ hospitals as discussed the Medicare FFS EHR hospital the first payment year, 2011, until the in section II.B.2.d. of this proposed rule. incentive program, we propose to use early part of 2012. Therefore, we would We propose to define ‘‘payment year’’ the hospital inpatient-bed-days data not be able to make payments to with respect to qualifying MA EPs in from the hospital fiscal year that ends qualifying MA organizations for MA EPs § 495.200. Section 1853(l)(3)(C) of the during the FFY prior to the fiscal year until claims submissions counted for Act directs us to establish the same first that serves as the payment year. For Medicare FFS incentive payments for payment year for all EPs with respect to qualifying MA-affiliated eligible CY 2011 have been closed, and payment any specific qualifying MA hospitals, we propose to compute calculations for participating EP under organization. Consistent with the hospital EHR incentive payments due in the Medicare FFS EHR incentive statute, we propose to pay a qualifying the same manner as they are being program have been completed in the MA organization on the same schedule computed in the Medicare FFS hospital early part of CY 2012. We will follow for all of its qualifying MA EPs. In other incentive payment program. For the same practice—first computing words, the first year during which the qualifying MA-affiliated eligible Medicare FFS incentive payments for qualifying MA organization receives an hospitals for which the first payment EPs and then computing and paying MA incentive payment for its qualifying EPs year is 2011 through 2013, up to 3 incentive payments, where will be considered the first payment additional years of incentive payments appropriate—in all subsequent payment year for all of its qualifying EPs. are available. For qualifying MA- years. Accordingly, for purposes of affiliated eligible hospitals for which the Subclause (II) of section determining the applicable incentive first payment year is after 2015, no EHR 1853(l)(3)(B)(i) of the Act further states payment limits, the second, third, payment incentive can be made for that that to the extent an MA EP is entitled fourth, and fifth years during which the year or any subsequent year. Finally, for to less than the maximum incentive qualifying MA organization receives an qualifying MA-affiliated eligible payment under the Medicare FFS EHR incentive payment for its qualifying EPs hospitals for which the first payment incentive program, that payment is to be will be considered the second, third, year is 2014 or 2015, only 2 (or 1) more made solely under the MA provision. In fourth, and fifth payments years for each year(s) of hospital incentive payments other words, we will need to withhold of its qualifying EPs, regardless of will be available. Medicare FFS incentive payments from whether the MA organization claimed Unlike the fixed schedule for EPs of less than the maximum to the an incentive payment for a particular EP application of limitation on incentive extent such professionals are also for a prior payment year. Such a payments for MA EPs discussed identified as MA EPs under section consistent payment cycle relative to previously in this section of the 1853(l)(2) of the Act. Again, we would qualifying MA organizations and proposed rule in which all employed/ need to await the computation of qualifying MA EPs obviates the need to partnering MA EPs will be paid on the payments due EPs under the Medicare track payment years and payment same schedule (first payment year, FFS EHR incentive program before we adjustment years based on prior second payment year, etc.) with respect can determine whether the EP is payments or adjustments with respect to to any specific qualifying MA entitled to less than the maximum any individual qualifying MA EP. organization, we propose to make payment amount under the Medicare Rather, for purposes of payment years payments to MA organizations for MA- FFS EHR program, in which case any and payment adjustment years, any EP affiliated eligible hospitals on a incentive payment for the EP will only employed by or partnering with any hospital-specific basis. In other words, if be made to the qualifying MA specific MA organization will be on the a qualifying MA organization has some organization under the MA EHR same cycle with respect to that MA-affiliated eligible hospitals with a program, and not to the EP under the organization. first payment year of FY 2011, it may Medicare FFS EHR program. Similar to the Medicare FFS EHR have other MA-affiliated eligible Section 1853(m)(3)(B) of the Act, incentive program, payment to hospitals with a first payment year of states that incentive payments for qualifying MA organizations for FYs 2012 through 2015. qualifying MA-affiliated eligible qualifying MA EPs and payment for hospitals are to be made under either qualifying MA-affiliated eligible 5. Avoiding Duplicate Payment the Medicare FFS hospital incentive hospitals is available only for a finite We propose duplicate payment payment program, or under the MA number of years. As previously avoidance provisions in § 495.208. hospital incentive payment program. If discussed in the section on the Section 1853(l)(3)(B) of the Act, as more than 33 percent of discharges or calculation of MA incentive payments, added by the HITECH Act, is entitled bed-days of all Medicare patients for a above, a qualifying MA organization can ‘‘Avoiding Duplication of Payments.’’ year are covered under Part A, then receive an incentive payment of up to Subclause (I) of the Act states that to the payment for that year is to only be made $18,000 for each of its qualifying MA extent an MA EP is entitled to the under section 1886(n) of the Act—the EPs for its first payment year if its first maximum incentive payment under Medicare FFS EHR incentive program— payment year is 2011 or 2012, or up to section 1848(o)(1)(A) of the Act, the and no payment is to be made under the $15,000, if its first payment year is 2013, Medicare FFS EHR incentive payment MA hospital incentive payment

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program. Otherwise, to the extent less payment, the organization must attest, qualifying MA organizations to continue than 33 percent of bed days of all in a form and manner specified by us, reporting under the existing MA quality Medicare patients for an incentive that its MA EPs and MA-affiliated reporting program. For those HITECH payment year are covered under Part A, eligible hospitals are meaningful EHR clinical quality measures that do not then payment for that incentive users, as required by sections 1853(l)(6) overlap and that are appropriate for the payment year may be made under the and 1853(m)(1) of the Act. We further MA program, we are considering MA EHR incentive payment program. propose to adopt the definitions of requiring that qualifying MA Unlike the process we propose to meaningful user proposed under the organizations that receive an incentive follow related to qualifying EPs (where Medicare FFS program related to EPs payment report those measures to CMS. we will wait for the Medicare FFS and hospitals in proposed § 495.4. We This would ensure that clinical quality incentive payment program to compute propose to require qualifying MA measure reporting under HITECH is eligible physician incentive payments organizations to attest each payment consistent between the FFS program due under that program before year whether each of its MA EPs and and MA. An alternative approach would determining the amount due under the MA-affiliated eligible hospitals for be to require that qualifying MA MA EHR incentive program), we would which it is seeking an incentive organizations that receive an incentive not need to rely on Medicare FFS EHR payment was a meaningful EHR user for payment report all of the HITECH incentive payment program calculations the EHR reporting period for a payment clinical quality measures under section before determining eligibility for MA- year. A qualifying MA organization II.A.2 of this proposed rule that are affiliated hospital incentive payments. must make this attestation for each appropriate for the MA program directly We would reimburse all hospitals, payment year for which it is seeking an to CMS, while also reporting those including MA-affiliated eligible incentive payment for MA EPs and MA- HEDIS, HOS, and CAHPS measures hospitals, under the Medicare FFS affiliated eligible hospitals. We believe under the existing MA quality program. hospital incentive program. We believe attestations should occur toward the This may result in duplicative reporting that by doing so, we will prevent end of a year with respect to that year, under the HITECH program and current duplicate payments being made for the since qualifying MA organizations will MA quality reporting, but may provide same hospitals by Medicare FFS and the need to attest to, based on our proposed us with more direct access to quality MA incentive payment programs. To the rule, meaningful use for the appropriate data under the HITECH program. We extent that qualifying MA organizations duration and during the appropriate invite public comment on these are to receive incentive payments period related to MA EPs and MA- approaches, including alternative through the MA program rather than affiliated eligible hospitals before methods to consistently treat MA- through their hospitals under the claiming incentive payments for them. affiliated providers and FFS providers Medicare FFS EHR incentive program Note that unlike the Medicare FFS under the HITECH Medicare incentive due to a lack of sufficient data to make EHR incentive program, where we will program. payments under the FFS program, we require the reporting of clinical quality would identify and reimburse only measures—see § 495.8—we will not Therefore, we propose requiring appropriate qualifying MA require qualifying MA organizations to qualifying MA organizations to submit organizations for qualifying MA- submit clinical quality measures per attestations to us related to meaningful affiliated eligible hospitals. Such section 1848(o)(2)(B) of the Act, with use by MA-affiliated hospitals within 30 reimbursement will be in a manner respect to EPs, and section 1886(n)(3)(B) days of the close of the FFY—which is similar to the manner in which the of the Act, with respect to eligible the payment year for MA-affiliated Medicare FFS EHR incentive program hospitals. Consistent with sections hospitals—by October 30. We also will reimburse eligible hospitals due an 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) propose requiring qualifying MA incentive payment under the Medicare of the Act, we note that qualifying MA organization to submit attestations to us FFS EHR incentive program. organizations sponsoring coordinated related to meaningful use by MA EPs In order to avoid duplicate payments care MA plans are already required to within 30 days of the close of the MA and in accordance with section submit Healthcare Effectiveness Data EP payment year—which is a CY—by 1853(m)(3)(B)(ii)(II) of the Act, we will and Information Set (HEDIS), Health January 30. not make MA EHR hospital incentive Outcomes Survey (HOS), and Consumer 7. Posting Information on the CMS Web payments to qualifying MA Assessment of Healthcare Providers and Site organizations for MA-affiliated eligible Systems (CAHPS) measures per hospitals other than through the § 422.152 and § 422.516. Coordinated Sections 1853(l)(7) and 1853(m)(5) of Medicare FFS EHR hospital incentive care MA plans include HMO, PPO and the Act, require us to post information payment program without first ensuring RPPO (Regional PPO) plans. Beginning on an Internet Web site related to the that no such payments under the with CY 2010, PFFS and MSA plans receipt of incentive payments under the Medicare FFS EHR hospital incentive will also be required to begin collecting MA EHR incentive program. payments were made. and submitting administrative HEDIS Information would include the names, We invite industry and public measures. business addresses, and business phone comment on our proposed process to We believe that all qualifying MA numbers of each qualifying MA eliminate duplicate payments to EPs organizations will be organizations organization receiving an incentive and MA-affiliated eligible hospitals offering MA coordinated care plans, and payment under this section for under the Medicare FFS and MA therefore; those MA organizations from qualifying MA EPs and hospitals. A list incentive payment programs. which we routinely receive complete of the names of each qualifying MA EP HEDIS dataset reporting. Pursuant to and qualifying MA-affiliated eligible 6. Meaningful User Attestation sections 1848(o)(2)(B)(iii) and hospital for which an incentive payment We propose meaningful user 1886(n)(3)(B)(iii) of the Act, for clinical has been made would also be posted. attestation requirements in § 495.210. quality measures which overlap Since this requirement is applicable to For each MA EP and MA-affiliated between the existing MA quality other Medicare EPs and eligible hospital for which a qualified MA reporting program and under the hospitals, we have included this organization seeks an incentive HITECH program, we propose to allow requirement in proposed § 495.108.

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8. Limitation on Review of the Act which exclude the EHR directed to apply the payment Section 1853(l)(8) of the Act states incentive payments made to EPs and adjustment on the proportion of the that there shall be no administrative or hospitals under the Medicare FFS capitation payment with respect to all judicial review under section 1869 of program from the computation of FFS such EPs of the organization that are not the Act, section 1878 of the Act, or costs in a year for the purpose of meaningful users for such year. The otherwise of the methodology and computing MA monthly capitation adjustment amount is 1 percent for standards for determining payment amounts. 2015, 2 percent in 2016, and 3 percent • Revising § 422.308 by adding a new amounts and payment adjustments in 2017 and subsequent years. paragraph (a)(1) to address the The statutory requirement related to under the MA EHR EP incentive amendments to section 1853(c)(1)(D)(1) imposition of payment adjustments with program. This includes provisions and (c)(6)(A) of the Act regarding the respect to MA-affiliated eligible related to duplication of payment exclusion of FFS Medicare EHR hospitals is provided in section 1853(m) avoidance and rules developed related incentive payments and adjustments of the Act. Specifically, section to the fixed schedule for application of from the calculation of the national per 1853(m)(4) of the Act requires us to limitation on incentive payments for all capita growth percentage. apply the adjustment to the hospital qualifying MA EPs related to a specific • Revising § 422.322 by adding a new expenditure proportion, which is our qualifying MA organization. This also paragraph (a)(3) to account for the estimate of the proportion of the includes the methodology and standards amendments to section 1853(c)(6)(A) expenditures under Parts A and B paid developed for determining qualifying and (f) of the Act specifying that the to the qualifying MA organization in the MA EPs and the methodology and source of EHR incentive payments to form of capitation payments under standards for determining a meaningful qualifying MA organizations are from section 1853 of the Act that are not EHR user, including the means of the Federal Hospital Insurance Trust attributable to the EHR incentive demonstrating meaningful use and the Fund or the Supplementary Medical payment program, that are attributable selection of measures. We propose to Insurance Trust Fund. to expenditures for inpatient hospital codify these requirements in • Revising § 422.322(b) by adding a services. In the case of a qualifying MA § 495.212(b). reference to § 495.204 to address the organization that attests that not all MA- Section 1853(m)(6) of the Act, as amendment to section 1851(i)(1) of the added by the HITECH Act, states that affiliated eligible hospitals of the Act that indicates that EHR incentive organization are meaningful EHR users there shall be no administrative or payments are instead of incentive judicial review under section 1869, with respect to years beginning with payments that would otherwise be 2015, we are directed to apply the section 1878, or otherwise of the payable under original Medicare. methodology and standards for payment adjustment on the proportion determining payment amounts and 10. Payment Adjustment and Future of all such MA-affiliated eligible payment adjustments under the MA Rulemaking hospitals of the organization that are not EHR hospital incentive program. This In future rulemaking we will develop meaningful users for such year. The includes provisions related to standards related to payment adjustment amount is of three-fourths of adjustments to qualifying MA the market basket increase related to a duplication of payment. This also 1 organizations related to MA EPs and hospital by a 33 ⁄3 percent reduction in includes the methodology and standards 2 developed for determining qualifying MA-affiliated eligible hospitals that are 2015, by a 66 ⁄3 percent reduction in MA hospitals and the methodology and not meaningful users of certified EHR 2016, and by a 100 percent reduction in standards for determining a meaningful technology. We solicit comment on how 2017 and all subsequent years. EHR user, including the means of we can most effectively and efficiently Effectively, the reduction is of all but 25 demonstrating meaningful use and the apply payment adjustments to percent of the market basket increase for selection of measures. We propose to qualifying MA organizations whose MA a specific hospital in years after 2016. We welcome comments on these codify these requirements in eligible EPs and hospitals have not incentive payment adjustments and on § 495.212(c). successfully meaningfully used certified EHR technology. how we can most effectively and 9. Conforming Changes The statutory requirement related to efficiently apply payment adjustments Sections 4101(e) and 4201(d)(2) and imposition of payment adjustments with to qualifying MA organizations whose (3) of the HITECH Act provide respect to MA EPs is set forth in section EPs and MA-affiliated hospitals have conforming amendments to Part C of the 1853(l) of the Act. Specifically, section not successfully meaningfully used Social Security Act. Therefore, we are 1853(l)(4) of the Act requires that certified EHR technology. Any proposing the following conforming instead of applying the payment comments received will be considered changes to the regulations text: adjustment in section 1848(a)(7) of the in developing future rulemaking. • Revising § 422.304 by adding a new Act, we apply the payment adjustment D. Medicaid Incentives paragraph (f) to account for the to the Medicare physician expenditure amendment to section 1853(a)(1)(A) of proportion. This is our estimate of the 1. Overview of Health Information the Act referencing the additional EHR proportion of the expenditures under Technology in Medicaid incentive payments that may be made to Parts A and B paid to the qualifying MA Under the HITECH Act, State qualifying MA organizations in the organization in the form of capitation Medicaid programs, at their option, may section of the statute that provides for payments under section 1853 of the Act receive Federal financial participation monthly capitation payments to MA that are not attributable to the EHR (FFP) for expenditures for incentive organizations. (This addition would also incentive payment program, that are payments to certain Medicaid providers act as a cross-reference to MA EHR attributable to expenditures for to adopt, implement, upgrade, and incentive payment rules in proposed physician services. In the case of a meaningfully use certified EHR subpart C of part 495 of this chapter.) qualifying MA organization that attests technology. Additionally, FFP is • Revising § 422.306(b)(2) by adding a that not all MA EPs of the organization available to States for administrative new paragraph (iv) to address the are meaningful EHR users with respect expenses related to administration of amendments to section 1853(c)(1)(D)(i) to years beginning with 2015, we are those incentive payments as long as the

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State meets certain conditions. Section that support it through collaboration EHR incentives leading up to our 1903(a)(3)(F)(i) of the Act, as amended between CMS and the States. The MITA development of this proposed rule. by section 4201 of the HITECH Act, framework consists of models, Issues addressed include policies such establishes 100 percent FFP to States for guidelines, and principles for States to as State oversight of adopting, providing incentive payments to eligible use as they plan and implement implementing, and upgrading certified Medicaid providers (described in business and technology enterprise EHR technology; alternative fiscal section 1903(t)(2) of the Act) to adopt, solutions. Integral to the MITA is the agents under consideration; and implement, upgrade, and meaningfully State’s Medicaid Management validating data to establish program use certified EHR technology. The Information System (MMIS). The MMIS eligibility. incentive payments are not direct contains a great deal of claims data and We also released a State Medicaid reimbursement for the purchase and other Medicaid programmatic Director’s letter on September 1, 2009. acquisition of such technology, but information that we believe should be This letter outlines steps State Medicaid rather are intended to serve as used by States in analyzing their current agencies can take to assess the current incentives for EPs and eligible hospitals HIT environments. Once States establish status of their HIT efforts; develop a to adopt and meaningfully use certified a baseline assessment, they can then roadmap for achieving their HIT EHR technology. plan the steps necessary to transition objectives in support of the Medicaid Section 1903(a)(3)(F)(ii) of the Act, as towards achieving some of the EHR incentive program; set Medicaid- amended by section 4201 of the HITECH objectives of the HITECH Act, such as specific performance goals and Act, also establishes 90 percent FFP to improving both quality of care and incentives for provider adoption of HIT; States for administrative expenses health care outcomes. In addition, the and partner with a broad range of related to carrying out the substantive MITA framework is CMS’s initiative stakeholders. Furthermore, we requirements associated with the that will allow States to modernize and conducted a follow-up technical incentive payments. As discussed later transform their MMIS to improve the assistance call with State Medicaid in this proposed rule, we interpret these administration of the Medicaid program, Directors and their staffs to provide an administrative expenses as including while supporting the States’ need for overview and answer questions. approvable expenses related to oversight flexibility, adaptability, and rapid Finally, as required by section activities and promotion of health response to changes in the unique 1903(t)(10) of the Act, we will be information exchange. aspects of their individual Medicaid reporting to Congress on the status, It is important to note that we do not programs. The ultimate goal of MITA is progress, and oversight of the overall believe that the Medicaid incentive and to develop seamless and integrated EHR incentive program. These reports administrative payments authorized systems that communicate effectively will discuss steps taken to avoid under section 4201 of the HITECH Act and that are interoperable, both within duplicate Medicare and Medicaid should be viewed in isolation. Rather, and across States as well as with other incentive payments to EPs, the extent to we encourage States, providers, and health care entities and payers, such as which Medicaid EPs and hospitals have other stakeholders to view these new public health departments and non- adopted certified EHR technology as a programs in concert with the numerous Medicaid payers. For more information result of the incentive payments, and other initiatives recently undertaken on MITA, we refer readers to: http:// any improvements in health outcomes, and currently being promoted by both www.cms.hhs.gov/ clinical quality, or efficiency resulting CMS and the Department to encourage MedicaidInfoTechArch/. from the adoption of such technology. advancements in health care technology We believe that the HITECH Act and health information exchange. These incentives create a unique opportunity • 2. General Medicaid Provisions initiatives include the following: for States and Medicaid providers to In the proposed § 495.342 and • The establishment of the Office of build upon prior and current efforts in § 495.344 we provide the general rule the National Coordinator (first through HIT in order to help achieve that States, at their option, may receive: executive order in 2004 and then as interoperable health information (1) 90 percent FFP for State legislatively mandated in the HITECH exchange in health care. We believe that expenditures related to the Act); States should build upon the lessons administration of an EHR incentive • The Medicaid Transformation Grant learned from these initiatives in order to program authorized by section 6081 of program for certain Medicaid providers ensure that the incentive and that are adopting, implementing, or the Deficit Reduction Act of 2005 (Pub. administrative payments are leveraged upgrading and meaningfully using L. 109–171). This program provided in a way that maximizes the role of HIT certified EHR technology; and (2) 100 $150 million in grants in FY 2007 in enhancing quality and access, percent FFP for State expenditures for through FY 2008 to States to support reducing costs, and improving health those incentive payments. innovative methods for transforming care outcomes. Medicaid programs. Twenty-two States We also plan to ensure public • 3. Identification of Qualifying focused on HIT, with initiatives ranging involvement as the HIT environment Medicaid EPs and Eligible Hospitals from the use of statewide EHRs for evolves, both as a result of the HITECH a. Overview beneficiaries, to mechanized clinical Act incentives, as well as a result of decision support, to e-prescribing, to other Departmental HIT initiatives. We As specified in section 1903(t)(2) of electronic health information exchange. have already convened several State the Act, only certain Medicaid providers For more information on the program, calls on the HITECH Act, including will be eligible for incentive payments. we refer readers to: http:// discussing the definition of meaningful This section of the preamble discusses www.cms.hhs.gov/ use of certified EHR technology, and the some of these eligibility requirements, MedicaidTransGrants. impact the definition would have on including requirements relating to • The Medicaid Information specific provider groups. More patient volume, whether a provider is Technology Architecture (MITA) information on the content of these calls hospital-based, and whether an EP is initiative and framework. MITA is a can be found in section II.A.2.a of this practicing predominantly in a federally- plan to promote improvements in the proposed rule. We convened additional qualified health center (FQHC) or a rural Medicaid enterprise and the systems calls with State staffs on the Medicaid health clinic (RHC). Proposed

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regulations relating to these (1) Acute Care Hospitals of this Medicaid EHR incentive program requirements may be found at § 495.304 ‘‘Acute care’’ is defined as the as those with an average patient length through § 495.306. necessary treatment of a disease or of stay of 25 days or fewer and with a CCN that has the last four digits in the • b. Program Participation injury for only a short period of time in which a patient is treated for a brief but series 0001 through 0879 (that is, short- As specified under section severe episode of illness.1 Many term general hospitals and the 11 cancer 1903(t)(2)(A) of the Act, Medicaid hospitals can be considered acute care hospitals in the United States). We also recognize a category of long- participating providers who wish to facilities if they provide both inpatient term care hospitals, which we are receive a Medicaid incentive payment and outpatient services with the goal of planning to exclude from the definition. must meet the definition of a ‘‘Medicaid discharging the patient as soon as the Long term acute care hospitals are EP.’’ This definition (1903(t)(3)(B) of the patient is deemed stable, with appropriate discharge instructions. We defined for Medicare purposes in Act) lists five types of Medicaid regulations at 42 CFR 412.23(e). professionals: Physicians, dentists, are proposing that for purposes of Medicaid incentive payments, an ‘‘acute Specifically § 412.23(e)(2)(i) states that certified nurse-midwives, nurse the hospital must have an average practitioners, and physician assistants care hospital’’ is defined as: A health care facility where the average length of Medicare inpatient length of stay of practicing in an FQHC or RHC that is so greater than 25 days (which includes all led by a physician assistant. patient stay is 25 days or fewer. For purposes of participation in the covered and non-covered days of stay of Additionally, to qualify for incentives, Medicaid EHR incentive program, this Medicare patients). We considered allowing both short- most Medicaid EPs cannot be ‘‘hospital- proposed definition ensures that term and long-term acute care hospitals based.’’ We propose to use the same hospitals are designated as acute care to meet the definition of acute care definition of ‘‘hospital-based’’ as used in hospitals based on the level and nature hospital for purposes of the Medicaid the Medicare EHR incentive program, as of care they provide. This definition incentive payments. However, we are sections 1848(o)(1)(C) and 1903(t)(3)(D) also includes some specialty hospitals not proposing a definition that of the Act use almost identical where the average length of stay is 25 encompasses both types of acute care definitions of the term. We refer readers days or fewer. This definition of acute hospitals because CMS’ interpretation to section II.A. of this preamble for a care hospitals will exclude specialty was that long-term acute care hospitals proposed definition of ‘‘hospital-based,’’ providers and long-term care facilities did not satisfy the intent of the statute, and for a thorough discussion of our where the average patients’ length of which we believe intends to include proposed methodology. stay exceeds 25 days. To further refine general acute care hospitals. In addition, the definition, we reviewed the The only exception to this rule is that CMS knew of at least one State that does Medicare-issued CCN. CCNs are issued Medicaid EPs practicing predominantly not recognize long-term acute care to categories of providers who meet in an FQHC or RHC are not subject to hospitals as a Medicaid provider type. Federal requirements (known as the hospital-based exclusion. We therefore drew the line at 25 days, conditions of participation) to Medicaid EPs must also meet the the cut-off between short-term general participate in the Medicare program. and specialty hospitals and long-term other criteria for Medicaid incentive State Medicaid agencies look to acute care hospitals. We used this cut- payment eligibility, such as the patient Medicare’s conditions of participation off in conjunction with the list of CMS volume thresholds or practicing when deciding whether to issue CCNs (which also distinguish between predominantly in an FQHC or RHC, as provider agreements to many categories short-term and long-term hospitals (see described in this subpart. Since the of providers. In the case of inpatient CMS State Operations Manual Section statute at 1903(t)(2)(iii) of the Act does hospital services § 440.10(a)(3)(iii) 2779A1, as revised on April 20, 2007 not define ‘‘practices predominantly,’’ requires that for inpatient hospital and effective on October 1, 2007) in we propose that an eligible professional services provided to Medicaid order to be as inclusive as possible practices predominantly at an FQHC or beneficiaries to be eligible for FFP, those within statute. Since Congress an RHC when the clinical location for services must be provided in an specifically singled out children’s over 50 percent of his or her total institution that meets the requirements hospitals in addition to acute care patient encounters over a period of 6 for participation in Medicare as a hospitals, we believe that if Congress months occurs at an FQHC or RHC. hospital, and such hospitals receive intended to include long-term care Acute care and children’s hospitals CCNs. hospitals, it would have similarly given are listed in section 1903(t)(2) of the Act Hospital CCNs are structured such them separate mention. In addition, as the only two types of institutional that the first two digits represent the Congress specifically did not include providers potentially eligible for State in which the hospital is located, nursing facilities, another category of Medicaid incentive payments. These and the next four digits identify the type long-term care provider (and an terms are specific to the Medicaid EHR of facility and are assigned sequentially important source of Medicaid care) as a incentive program and are not currently from the appropriate block of numbers. provider type eligible for incentive defined in the Medicaid regulations. Short-stay general hospitals receive payments. CMS read this as further Consequently, we propose to define CCNs whose number range is 0001 evidence that the statute did not intend these terms in § 495.302. through 0879. The 11 cancer hospitals in the United States also are issued inclusion of long-term care facilities. As specified under section CCNs within that number range. To 1903(t)(2)(B) of the Act, to qualify for (2) Children’s Hospitals allow some flexibility for hospital incentive payments acute care hospitals The statute also does not include a participation in the Medicaid EHR also must meet patient volume definition for ‘‘children’s hospitals.’’ To incentive program, we are proposing to threshold requirements, as specified in assist with the development of a define acute care hospitals for purposes proposed § 495.306. Children’s hospitals definition of ‘‘children’s hospitals’’ for do not have patient volume 1 State of Connecticut, Office of Health Care purposes of the Medicaid EHR incentive requirements for Medicaid incentive Access, ‘‘The Health of Connecticut’s Hospitals,’’ program, we convened teleconferences program participation. report released January 16, 2001, page 17. with States to gather input on topics

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that should be defined in this proposed incentive payment; (2) allow for Insurance Program (CHIP); (2) they are rule. Participants noted that one critical participation in the incentive program furnished uncompensated care by the issue is whether a children’s wing of a by the greatest number of children’s provider; or (3) they are furnished general hospital could be considered a hospitals, including rehabilitative and services at either no cost or reduced cost children’s hospital for purposes of psychiatric specialty hospitals; and (3) based on a sliding scale determined by qualifying for a Medicaid incentive align with Federal efforts aimed at the individual’s ability to pay. An payment. improving healthcare quality for all explanation of how we propose to apply As with the acute care hospital children, including those with physical each of these criteria is described in definition, we again looked to Medicare- and mental diseases/disabilities. detail in this section of the proposed issued CCNs and recognized that We are soliciting comment on the rule. numbers whose last four digits are in proposed definitions of ‘‘children’s We propose this flexible patient the 3300 to 3399 series are assigned to hospital’’ as it applies to the Medicaid volume methodology in order to capture children’s hospitals. Currently in the EHR incentive program recognizing that the highest number of true Medicaid United States there are 78 certified there may be additional alternative practitioners potentially eligible for the children’s hospitals, including both definitions that could have a positive EHR incentive program. We believe freestanding and hospital-within- impact on the health care received by Congress set the high patient volume hospital facilities. children. thresholds in order to offer these For purposes of the Medicaid EHR incentives to the practitioners whose c. Medicaid Professionals Program incentive program, we propose one practices are open and accessible to Eligibility definition to include only separately Medicaid beneficiaries. We noted that certified children’s hospitals, with CCNs For Medicaid EPs, the general rule many Medicaid eligible individuals, in the 3300–3399 series in the definition (subject to the two exceptions listed such as children, may seek care at of eligible ‘‘children’s hospital.’’ By below) is that the EP must have at least specified times of the year, such as the proposing to define ‘‘children’s hospital’’ 30 percent patient volume attributable beginning of the school-year for in this way, CMS would (1) prevent to those who are receiving Medicaid. required immunizations. Since there are general acute care hospitals, which Section 1903(t)(2)(A)(i) of the Act five different types of providers, varying cannot themselves qualify for the provides authority to the Secretary to from specialty to primary care, we incentive because they do not meet the establish the methodology by which thought the flexibility would capture 10 percent Medicaid patient volume, such patient volume will be estimated. any seasonal encounter adjustments in from using the fact that they have a We propose that to establish such the year, while still honoring Congress’ pediatric wing as justification for patient volume, the EP must have a intent to reward higher-volume requesting a Medicaid incentive minimum of 30 percent of all patient Medicaid practitioners. payment; (2) exclude many of the encounters attributable to Medicaid over any continuous 90-day period within d. Calculating Patient Volume facilities that are perceived by the Requirements public as children’s hospitals, but do the most recent calendar year prior to not meet the Medicare standards as reporting. There are two exceptions to As required by section 1903(t)(2) of either freestanding or hospital-within- the general 30 percent rule discussed the Act and discussed in the previous hospital children’s hospitals; and (3) previously. The first exception is that a section, all EPs and the vast majority of exclude some pediatric specialty pediatrician may have at least 20 hospitals will need to meet certain hospitals which have CCNs as percent patient volume attributable to patient volume thresholds in order to be psychiatric or rehabilitation hospitals. those who are receiving health care eligible for incentive payments. (The An alternative proposed definition of services under the Medicaid program, as only exception to this rule is for a ‘‘children’s hospital’’ would include estimated in accordance with a children’s hospitals, which have no those hospitals with Medicare provider methodology established by the patient volume threshold requirement). numbers in the following series: Secretary (section 1903(t)(2)(A)(ii) of the In addition, where patient volume is • 0001 through 0879—Short-term Act). Again, the method we propose to a criterion, most providers will be (General and Specialty) Hospitals. use is that the pediatrician must have a evaluated according to their ‘‘Medicaid’’ • 3025 through 3099—Rehabilitation minimum 20 percent of all patient patient volume, while some Hospitals (Excluded from Prospective encounters attributable to Medicaid over professionals (those practicing Payment Systems). any continuous 90-day period within predominantly in an FQHC or RHC) will • 3300 through 3399—Children’s the most recent calendar year prior to be evaluated according to their ‘‘needy Hospitals (Excluded from Prospective reporting. individual’’ patient volume. Payment Systems). The second exception is that We propose to define ‘‘patient • 4000 through 4499—Psychiatric Medicaid EPs practicing predominantly volume’’ in § 495.302 to be a minimum Hospitals (Excluded from Prospective in an FQHC or RHC must have a participation threshold for each Payment Systems). minimum of 30 percent patient volume individual Medicaid provider (with the This definition, for the purposes of attributable to ‘‘needy individuals.’’ exception of children’s hospitals). the Medicaid HIT Incentive payments, Again, the method we propose to use is For the Medicaid patient volume, this would apply only to those freestanding that 30 percent of all patient encounters threshold (represented below) is hospitals within the above mentioned be attributable to needy individuals over calculated using as the numerator the series that exclusively furnish services any continuous 90-day period within individual hospital’s or EP’s total to individuals under age 21. the most recent calendar year prior to number of Medicaid patient encounters This broader definition would (1) still reporting. in any representative continuous 90-day prevent acute care hospitals that cannot Section 1903(t)(3)(F) of the Act period in the preceding calendar year independently qualify for the incentive defines needy individuals as and the denominator is all patient because they do not meet the 10 percent individuals meeting any of the encounters for the same individual Medicaid patient volume from using the following three criteria: (1) They are professional or hospital over the same fact that they have a pediatric wing as receiving medical assistance from 90-day period. We are not prescribing justification for requesting an HIT Medicaid or the Children’s Health standards for what is a ‘‘representative’’

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period, but we intend to apply a plain calendar year/Total patient encounters period in the preceding calendar meaning test. In other words, if a in that same 90-day period] * 100 year/Total patient encounters in that reasonable person would not consider For the needy individual patient same 90-day period] * 100 volume, the threshold (represented the selected period to be representative Medicaid EPs and eligible hospitals (for example, because the selected below) is calculated in the same manner, but with the numerator equal to would be required to annually re-attest period included a short-term temporary to patient volume thresholds to Medicaid outreach program), then it the EP’s total number of needy individual patient encounters in any continue to qualify for Medicaid would not support a threshold incentive payments. Table 26 calculation. representative 90-day period in the preceding calendar year. demonstrates the above-referenced [Total (Medicaid) patient encounters [Total (Needy Individuals) patient patient volume thresholds per provider in any 90-day period in the preceding encounters in any continuous 90-day type.

TABLE 26—QUALIFYING PATIENT VOLUME THRESHOLD FOR MEDICAID EHR INCENTIVE PROGRAM

Minimum 90-day Medicaid patient Entity volume threshold (percent)

Physicians ...... 30 Or the Medicaid EP practices predominantly in an FQHC or RHC—30% ‘‘needy individual’’ patient volume threshold. Pediatricians ...... 20 Dentists ...... 30 Certified nurse midwives ...... 30 Physician Assistants when practicing at an FQHC/RHC led 30 by a physician assistant. Nurse Practitioner ...... 30 Acute care hospital ...... 10 Children’s hospital ......

If a State has an alternative approach services. ‘‘Accounts receivable’’ and eligible for Medicaid EHR incentive to the established timeframe for ‘‘notes receivable’’ are designations for payments because those payments are measuring patient volume, it may claims arising from the furnishing of not for services that are included in propose it to us for review through the services, and are collectible in money in such a contract. The fact that Congress State Medicaid HIT Plan (SMHP) the relatively near future. Providers directed that individuals enrolled in (discussed later) and we would make a should be required to use cost reports managed care be included in the patient determination of whether it is an (for FQHCs and clinics this would be volume calculation demonstrates an acceptable alternative. To be considered the Medicare 222–92 cost report, or the intent to allow qualified providers to for approval, the alternative approach most recent version of the 222), or other receive incentive payments, whether would require a verifiable data source auditable records to identify bad debts. they provided their services through and justification. In defining the way in All information under attestation is capitated care arrangements or fee-for- which patient volume is established, we subject to audit. Our proposed service. Over 70 percent of Medicaid provide for a consistent methodology regulations on calculating the needy beneficiaries receive care in a managed per the statute, but also allow for the individual patient volume can be found care delivery system, and we do not possibility that States may propose at § 495.302 and § 495.306. believe that the intent of Congress in acceptable alternatives that synchronize Further, in establishing the Medicaid creating the incentives program was to with existing data sources, which could patient volume thresholds for EPs and remove the providers treating these decrease State data burdens. This acute care hospitals, section 1902(t)(2) individuals from the incentives alternative approach must provide an of the Act requires that individuals program. auditable record (that is, a record of how enrolled in Medicaid managed care e. Entities Promoting the Adoption of the professional demonstrated patient organizations (MCOs), prepaid inpatient Certified EHR Technology volume) for CMS to monitor the States’ health plans (PIHPs), or prepaid oversight of the Medicaid EHR incentive ambulatory health plans (PAHPs), under We are proposing to define program implementation. 42 CFR Part 438 be included in the ‘‘promoting the adoption of certified In determining the ‘‘needy individual’’ calculation. Therefore, in determining EHR technology’’ in § 495.302. Under patient volume threshold that applies to patient volume, providers and States section 1903(t)(6)(A)(i), incentive EPs practicing predominantly in FQHCs should be aware that individuals payments must generally be made or RHCs, section 1902(t)(2) of the Act enrolled in such plans will be included directly to the EP. Section authorizes the Secretary to make a in the patient volume calculation. Acute 1903(t)(6)(A)(ii) of the Act provides an downward adjustment to the care hospitals have to meet the 10 exception to permit payment of uncompensated care figure to eliminate percent Medicaid volume threshold. incentive payments to ‘‘entities bad debt data. We interpret bad debt to We also note that although § 438.60 of promoting the adoption of certified EHR be consistent with the Medicare our regulations would generally prohibit technology,’’ as designated by the State, definition, as specified at § 413.89(b)(1). a State from making a direct payment to if participation in the payment Under Medicare, bad debts are amounts a provider for services that are included arrangement is voluntary for the EP considered to be uncollectible from under a contract with an MCO, PIHP, or involved. Additionally, the entity must accounts and notes receivable that were PAHP, providers contracted with these not retain more than 5 percent of the created or acquired in providing managed care plans will nevertheless be payment for costs unrelated to certified

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EHR technology (and support services interoperable health information 4. Computation of Amount Payable to including maintenance and training) exchange. HIEs promote adoption of Qualifying Medicaid EPs and Eligible that is for, or is necessary for, the certified EHR technology by providing Hospitals operation of the technology. While the the infrastructure for providers’ EHRs to The statute, at sections 1903(t)(1), Act authorizes States to designate these reach outside of their clinical practice (t)(4), and (t)(5) of the Act, creates entities, the Secretary nevertheless sites and connect with other points of different payment formulas for retains authority to define what it means care. Providers report that having a Medicaid EPs versus hospitals. The to be ‘‘promoting the adoption of more complete picture of their patients’ payment methodology for Medicaid certified EHR technology,’’ as specified healthcare data from other providers hospitals shares many aspects of the in section 1903(t)(6)(A)(ii) of the Act. and care settings is one of the primary methodology used for Medicare Section 1102 of the Act authorizes the appeals to using EHRs. Without health hospitals. Secretary to ‘‘make and publish such information exchange, electronic health rules and regulations, not inconsistent records are simply digitized filing a. Payment Methodology for EPs with this Act, as may be necessary to the cabinets and will not achieve their (1) General Overview efficient administration of the functions quality of care or cost containment Pursuant to section 1903(t)(1)(A) of with which he or she is charged under potential. Furthermore, given the the Act, payment for EPs equals 85 this Act.’’ Since one of our functions is proposed definition of meaningful use, percent of ‘‘net average allowable costs.’’ to approve Title XIX plans under HIEs can significantly help Medicaid While the Secretary is directed to sections 1902(b) and 1116 of the Act, providers adopt and use EHR in such a determine ‘‘average allowable costs’’ and States would need to submit plans way that the goals of the incentive based upon studies of the average costs as to how they would spend section program are met. The inclusion in of both purchasing and using EHR 4201 of the HITECH Act funds, we have HITECH of HIE grants to be awarded to technology, the net average allowable the authority to determine whether a States or State-designated Entities by costs that set payment are capped by State’s plan for allowing EPs to assign ONC are an additional indication of the statute. As discussed in more detail their Medicaid incentive payments to symbiotic relationship between health further on, generally stated, these caps these entities is in compliance with our information exchanges and optimal use equal $25,000 in the first year, and interpretation of the Act. of EHRs. $10,000 for each of 5 subsequent years We propose to define ‘‘promoting’’ Under 1903(t)(6)(A)(ii) of the Act and (there is an exception for pediatricians certified EHR adoption to mean the as proposed in § 495.354, States must with under 30 percent Medicaid patient enabling and oversight of the business, establish verification procedures that volume, whose caps are two-thirds of operational and legal issues involved in enable Medicaid EPs to voluntarily these amounts). Thus, the maximum the adoption and implementation of assign payments to entities promoting incentive payment an EP could receive EHR and/or exchange and use of EHR technology. States must guarantee from Medicaid equals 85 percent of electronic health information between that the assignment is voluntary and $75,000, or $63,750, over a period of 6 participating providers, in a secure that the entity does not retain more than years. EPs must begin receiving manner, including maintaining the 5 percent of those assigned Medicaid incentive payments no later than CY physical and organizational relationship incentive payments for costs unrelated 2016. integral to the adoption of certified EHR to certified EHR technology. We propose technology by EPs. For example, health (2) Average Allowable Costs requiring States to publish and make information exchanges have the available to all Medicaid EPs the Section 1903(t)(4)(C) of the Act gives potential to transform the healthcare procedures they developed for assigning the Secretary the authority to determine system by facilitating timely, accurate, incentive payments to the third party average allowable costs. Specifically, and portable health information on each the Secretary is directed to study the entities before payments can be patient at the point of service. Health average costs associated with the assigned. Such publication must also Information Exchanges (HIEs), are one purchase, initial implementation, and include information about the State’s type of entity that we believe would upgrade of certified EHR technology, verification mechanism. The State’s meet the definition of an entity that is including support services, and integral method must assure compliance with promoting the adoption of certified EHR related training. The Secretary also is the requirement that no more than 5 technology. HIEs provide the capability directed to study the average costs of percent of the Medicaid EP’s annual to move clinical information operating, maintaining, and using incentive payment is retained by the electronically between disparate health certified EHR technology. The statute entity for costs not related to certified care information systems while permits the Secretary to use studies EHR technology. maintaining the meaning of the submitted by the States. information being exchanged. HIEs also Although section 1903(t)(6)(A)(ii) of We conducted a literature review of provide the infrastructure for secondary the Act allows assignment of payment to recent studies on EHR technology to use of clinical data for purposes such as entities promoting the adoption of EHR determine the average allowable cost of public health, clinical, biomedical, and technology, we wish to clarify that such implementing and using such consumer health informatics research as assignment would not remove the technology. We reviewed the results well as institution and provider quality responsibility of the Medicaid EP to from four recent, comprehensive assessment and improvement, where individually demonstrate meaningful studies. Specifically, HHS’ Office of the permissible under HIPAA and other use of the EHR technology (as discussed Assistant Secretary for Planning and requirements included in the HITECH in greater detail below). Therefore, Evaluation commissioned a study by Act. In addition, use of health entities promoting the adoption would Moshman Associates, Inc., Booz Allen information exchange models can not receive the assigned payments Hamilton, in September 2006— reduce the need for costly point-to-point unless the Medicaid EP meets all Assessing the Economics of EMR interfaces between different EHR tools, eligibility criteria. Our proposed Adoption and Successful as used in laboratories and pharmacies, definition for promoting the adoption of Implementation in Physical Small thus providing a more scalable model of certified EHR technology is in § 495.302. Practice Settings. In this study, EHRs

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consisted of a core group of functions about $25,000—$45,000 per physician 6 the new standards will be higher than that, in various permutations, are often and estimates for annual costs for the current costs of EHR technology. It associated with an electronic medical operating and maintaining the system, is our assumption that making record and frequently include the which include software licensing fees, improvements to incorporate the new capacity to: Capture and display clinical technical support, and updating and certification standards into current EHR notes, display laboratory results, display replacing used equipment range technology will be costly. Thus, we diagnostic imaging results or reports, between $3,000 to $9,000 per physician believe that establishing the average order drugs or diagnostic tests, and per year.7 allowable cost at $54,000 is reasonable. generate reports.2 An article written by the Agency for Additionally, our analysis determined Healthcare Research and Quality that the range for subsequent incentive The study found that EHR adoption is (AHRQ), Research Activities, September payment year costs for most providers influenced by a variety of factors, 2005, Health Information Technology, will fall into a large range, based on a including hardware costs, software adoption rates of electronic health number of factors. On one end of the costs, the costs of implementation and records are low among physician range, costs related to maintenance training, and costs associated with groups—indicates that the average could be as low as $3,000 to $9,000 per productivity that occur in the early purchase and implementation cost of an provider, where other studies state that stages of implementation. While there EHR was $32,606 per FTE physician. maintenance will be as high as $18,000 are challenges in making cost The article indicates that maintenance to $20,610 per provider. Given the comparisons across different studies costs were an additional $1,500 per expectations in the ONC interim final and across different functionalities (that physician, per month and smaller rule for system performance, is, EMRs versus EHRs), the costs per practices had the highest interoperability, and the health physician ranged between $33,000 and implementation costs per physician at measures data discussed in this $50,000.3 $37,204.8 proposed rule that CMS and the States In reviewing Market Watch, The In conducting a review of the data, we will need to collect from professionals, Value of Electronic Health Records in determined that the studies demonstrate we believe that the costs for maintaining Community Health Centers: Policy a cross-sectional view of small and large certified EHR technology will also be on Implications by Robert H. Miller and practices and community health centers. the higher end of the range at $20,610. Christopher E. West, the cost and There was adequate data to support a depiction of costs across multiple (3) Net Average Allowable Costs benefits of electronic health records is provider types. As required by section 1903(t)(3)(E) of reported in six community health To summarize, we determined that the Act, in order to determine ‘‘net’’ centers (CHCs) that serve disadvantaged average allowable costs, average 4 the average costs of EHRs vary greatly patients. Robert Miller and Christopher because of the size and type of provider allowable costs for each provider must West report that initial EHR costs per practices, the differences in available be adjusted in order to subtract any full-time-equivalent (FTE) billing features of systems, and the additional payment that is made to Medicaid EPs provider averaged almost $54,000, with costs associated with licensing, support, and is directly attributable to payment much variation across CHCs and within training, and maintenance. However, for certified EHR technology or support each cost category, including hardware, based on the information reviewed, we services of such technology. The only software, installation, training, etc. and determined that the average costs for exception to this requirement is that ongoing costs per FTE provider, per initial EHR systems currently can range payments from State or local year, averaged $20,610.5 from $25,000 to $54,000 in the governments do not reduce the average A Congressional Budget Office (CBO) implementation year, per professional. allowable costs. The resulting figure is Paper: Evidence on the Costs and Since the average costs of EHR the ‘‘net’’ average allowable cost; that is, Benefits of Health Information technology in the first year can be as average allowable cost minus payments Technology from May 2008 indicates much as $54,000 and no less than from other sources (other than State or that estimating the total cost of $25,000, and since we believe the costs local governments). The statute implementing HIT systems in office- of such technology will be increasing, indicates that EPs may receive 85 based medical practices is complicated we are proposing to set the average percent of a maximum net average by differences in the types and available allowable cost at $54,000. We believe allowable cost in the first year of features of the systems now being sold, that to establish this average allowable $25,000 and a maximum net average as well as differences in characteristics cost at the high end of the range is allowable cost of $10,000 in subsequent of the practices that adopt them. The reasonable since the data we reviewed years. This would mean that, as CBO paper goes further to say that few is based on certification standards that required by the statute, the net average detailed studies available report that may not be appropriate moving forward. allowable costs are capped at these total costs for office-based EHRs are Specifically, since the ONC will be amounts. establishing new certification standards Since we have proposed that the for EHR technology in the coming average allowable cost is $54,000 in the 2 Moshman Associates, Inc., Booz Allen Hamilton, in September 2006—Assessing the months, we believe the average cost of first year, EPs could receive as much as Economics of EMR Adoption and Successful certified EHR technology incorporating $29,000 in funding from sources (other Implementation in Physical Small Practice Settings, than from State or local governments) as p. 40. 6 A CBO Paper, Evidence on the Costs and contributions to the certified EHR 3 Moshman Associates Inc., Booz, Allen, Benefits of Health Information Technology, May technology and the incentive payment Hamilton, p. 50. 2008, p. 17. 4 Market Watch, The Value of Electronic Health 7 A CBO Paper, Evidence on the Costs and would still be based on 85 percent of the Records in Community Health Centers: Policy Benefits of Health Information Technology, May maximum net average allowable cost of Implications by Robert H. Miller and Christopher E. 2008, p. 18. $25,000 (or $21,250). This is appropriate West, p. 206. 8 Agency for Healthcare Research and Quality, since $54,000 (the average allowable 5 Market Watch, The Value of Electronic Health Research Activities, September 2005, Health cost) minus $29,000 (contributing Records in Community Health Centers: Policy Information Technology, Adoption rates of Implications by Robert H. Miller and Christopher E. electronic health records are low among physician sources of funding from other than State West, p. 208. groups. or local governments) equals $25,000.

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Since $25,000 is equal to the level of the support service, or training from another cap on net average allowable cost, or up maximum net average allowable cost or source are extremely limited in light of to a maximum of $8,500 annually for capped amount discussed above, the statutory prohibitions on most Medicaid EPs. providers could receive 85 percent of ‘‘kickbacks’’ at Section 1128B(b) of the Since pediatricians are qualified to $25,000 or $21,250 in year one as a Act. participate in the Medicaid EHR Medicaid incentive payment. incentive program as physicians, and (4) Payments for Medicaid Eligible The same logic would hold true for therefore classified as Medicaid EPs, Professionals subsequent years. Specifically, if in the they may qualify to receive the full following years an eligible professional One important difference we propose incentive (that is, the 85 percent received as much as $10,610 in between the payments to Medicaid EPs threshold applied to the net average contributing funds from sources other and hospitals is that States would allowable cost) if the pediatrician is not than State or local governments, the disburse the payments to EPs in hospital-based and can demonstrate that maximum incentive payment of $8,500 alignment with the calendar year, they meet the minimum 30 percent would be unaffected in such subsequent whereas hospitals will receive payments Medicaid patient volume requirements years. This result is due to the fact that in alignment with the fiscal year, as discussed in this subpart. the average allowable costs of $20,610 described in section II.D.4.b. of this Pediatricians who are not hospital- for maintaining EHR technology minus proposed rule. There are two primary based, and have a minimum of 20 the $10,610 received would still equal reasons for this. The first is to align percent of their patient encounters paid $10,000, the maximum net average Medicaid incentive payment by Medicaid are also encouraged to allowable costs permitted under the disbursements with that of the Medicare participate in the Medicaid EHR statute. program, in order to support incentive program. The maximum In reviewing whether a reduction in consistency between the two programs, payment amount for these pediatricians, the net average allowable cost was as well as among the States. We will who meet the 20 percent Medicaid warranted based on other contributions undertake national outreach activities to patient volume, but fall short of the 30 to EHR technology, we considered the encourage provider EHR adoption and percent patient volume, is reduced to situation of EPs who may have been to align the annual payment periods. two-thirds of the net average allowable provided with the actual certified EHR Since meaningful use of the certified cost, subject to the 85 percent threshold. technology, as well as training, support EHR technology is the driver of the The reduction accounts for the reduced services, and other services that would incentives, we believe that a cooperative patient volume, but the intent is to offer promote the implementation and approach between CMS, ONC, and the an incentive to attract pediatricians to meaningful use of such technology. In States would be realized with more participate. This means pediatricians some cases, we do not believe the providers participating in the program. with a minimum 20 percent patient contribution would reduce average As previously discussed in this volume may qualify for up to a allowable costs at all. For example, if an proposed rule, based on the 85 percent maximum of $14,167 in the first FQHC or RHC has provided technology threshold applied to the net average incentive payment year and up to a to its staff EPs to use, we do not believe allowable costs, we propose that most maximum of $5,667 in the 5 subsequent that such technology provision would Medicaid EPs may receive up to a incentive payment years, or no more be considered a ‘‘payment’’ from another maximum incentive payment of $21,250 than $42,500 over the maximum 6 year source that would reduce average in the first payment year. period. allowable costs. Moreover, we believe In subsequent years of payment, Table 27 demonstrates the various the situations in which an EP has been Medicaid EPs’ incentive payments will maximum incentive payment amounts provided with the actual technology, be limited to 85 percent of the $10,000 for Medicaid professionals.

TABLE 27—MAXIMUM INCENTIVE PAYMENT AMOUNT FOR MEDICAID PROFESSIONALS

85 percent Maximum Cap on net average allowable costs, per the HITECH Act allowed for eligible cumulative incentive professionals over 6-year period

$25,000 in Year 1 for most professionals ...... $21,250 ...... $10,000 in Years 2–6 for most professionals ...... 8,500 $63,750 $16,667 in Year 1 for pediatricians with a minimum 20 percent patient volume, but less than 30 percent patient volume, Medicaid patients ...... 14,167 ...... $6,667 in Years 2–6 for pediatricians with a minimum 20 percent patient volume, but less than 30 percent patient volume, Medicaid patients ...... 5,667 42,500

(5) Basis for Medicaid EHR Incentive payments not in excess of the maximum in the Medicaid EHR incentive program Program First Payment Year and amount. Under section 1903(t)(4) of the for up to 6 years. Subsequent Payment Years Act he or she is eligible to receive up Table 28 demonstrates the payment (i) Medicaid EP Who Begins Adopting, to the maximum first year Medicaid scenarios available to a Medicaid EP Implementing or Upgrading Certified incentive payments discussed in the who begins in their first year by EHR Technology in the First Year previous sections, plus additional adopting, implementing, or upgrading incentive payments for up to 5 years for certified EHR technology. As can be A Medicaid EP who begins by demonstrating meaningful use of seen from the table, the EP can begin adopting, implementing, or upgrading certified EHR technology. In other receiving payments as late as 2016, and certified EHR technology in the first words, these providers may participate still receive up to the maximum year will be eligible for the incentive payments under the program.

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TABLE 28—PAYMENT SCENARIOS FOR MEDICAID EPS WHO BEGIN ADOPTION IN THE FIRST YEAR

Medicaid EPs who begin adoption in Calendar year 2011 2012 2013 2014 2015 2016

2011 ...... $21,250 ...... 2012 ...... 8,500 $21,250 ...... 2013 ...... 8,500 8,500 $21,250 ...... 2014 ...... 8,500 8,500 8,500 $21,250 ...... 2015 ...... 8,500 8,500 8,500 8,500 $21,250 ...... 2016 ...... 8,500 8,500 8,500 8,500 8,500 $21,250 2017 ...... 8,500 8,500 8,500 8,500 8,500 2018 ...... 8,500 8,500 8,500 8,500 2019 ...... 8,500 8,500 8,500 2020 ...... 8,500 8,500 2021 ...... 8,500

Total ...... 63,750 63,750 63,750 63,750 63,750 63,750

(ii) Medicaid EP Who Has Already EHR technology ‘‘prior to the first year payment, with payments not exceeding Adopted, Implemented or Upgraded of payment. * * * clause (i)(I) shall not $8,500 in each of these 5 subsequent Certified EHR Technology and apply and clause (i)(II) [discussing the years. This approach allows early Meaningfully Uses EHR Technology demonstration of meaningful use] shall adopters of certified EHR to begin For a Medicaid EP who has already apply to each year of payment to the meaningfully using technology, without adopted, implemented, or upgraded Medicaid provider under this being at a competitive disadvantage, and certified EHR technology and can subsection, including the first year of without losing incentive payments for meaningfully use this technology in the payment.’’ We believe this provision the previous costs associated with first incentive payment year, we supports an interpretation that a adopting, implementing, or upgrading propose that the Medicaid EP be Medicaid EP who has already adopted certified EHR technology. permitted to receive the same maximum certified EHR technology, would still Thus, the maximum incentive payments, for the same period of time, receive a ‘‘first year’’ of payment under payments for Medicaid EPs as the Medicaid EP who merely section 1903(t)(4) of the Act, and like all demonstrating that they are meaningful adopted, implemented or upgraded other first years of payment, this users in the first payment year, would certified EHR technology in the first payment could not exceed $21,250. be identical to the maximum payments year. Section 1903(t)(6)(C)(ii) of the Act Then, under section 1903(t)(4)(A)(ii) available to those demonstrating states that for a Medicaid EP or hospital and (iii) of the Act, such Medicaid EPs adoption, implementation, or upgrading who has completed ‘‘adopting, could receive an additional 5 years of certified EHR technology in the first implementing, or upgrading’’ certified payment for subsequent years of year, as depicted in Table 29.

TABLE 29—MAXIMUM INCENTIVE PAYMENTS FOR MEDICAID EPS WHO ARE MEANINGFUL USERS IN THE FIRST PAYMENT YEAR

Medicaid EPs who begin meaningful use of certified EHR technology in Calendar year 2011 2012 2013 2014 2015 2016

2011 ...... $21,250 ...... 2012 ...... 8,500 $21,250 ...... 2013 ...... 8,500 8,500 $21,250 ...... 2014 ...... 8,500 8,500 8,500 $21,250 ...... 2015 ...... 8,500 8,500 8,500 8,500 $21,250 ...... 2016 ...... 8,500 8,500 8,500 8,500 8,500 $21,250 2017 ...... 8,500 8,500 8,500 8,500 8,500 2018 ...... 8,500 8,500 8,500 8,500 2019 ...... 8,500 8,500 8,500 2020 ...... 8,500 8,500 2021 ...... 8,500

Total ...... 63,750 63,750 63,750 63,750 63,750 63,750

An alternative approach we request 1903(t)(4)(A) of the Act, which states would still be eligible to receive comment on would be to limit the that the $25,000 cap on net average incentive payments, the payment totals incentive payment for Medicaid EPs allowable costs is intended to cover the would be lower, because such adopters who have already adopted, costs of implementing or adopting would not need an incentive payment in implemented, or upgraded certified EHR certified EHR technology, as limiting the order to actually implement, adopt, or technology to 5 years of payment, at a $21,250 payment only to those actually upgrade certified EHR technology. This maximum payment of $8,500 per year. adopting the technology in their first alternative approach is depicted in This approach would interpret section year of payment. While early adopters Table 30.

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TABLE 30—ALTERNATIVE INCENTIVE PAYMENT SCENARIO FOR MEDICAID EPS WHO HAVE ADOPTED EHR TECHNOLOGY BEFORE THE FIRST YEAR

Medicaid EPs who begin meaningful use in Calendar year 2011 2012 2013 2014 2015 2016

2011 ...... $8,500 ...... 2012 ...... 8,500 $8,500 ...... 2013 ...... 8,500 8,500 $8,500 ...... 2014 ...... 8,500 8,500 8,500 $8,500 ...... 2015 ...... 8,500 8,500 8,500 8,500 $8,500 ...... 2016 ...... 8,500 8,500 8,500 8,500 $8,500 2017 ...... 8,500 8,500 8,500 8,500 2018 ...... 8,500 8,500 8,500 2019 ...... 8,500 8,500 2020 ...... 8,500 2021 ......

Total ...... 42,500 42,500 42,500 42,500 42,500 42,500

Medicaid EPs are not required to refer, with some adjustments, to the for each year equals 1 in year 1, 3⁄4 in participate on a consecutive annual calculation for the Medicare hospital year 2, 1⁄2 in year 3, and 1⁄4 in year 4. basis. The tables in this section incentive payment described at sections The statute specifies that the payment demonstrate how a Medicaid EP would 1886(n)(2)(A), 1886(n)(2)(C), and year is determined based on a Federal maximize the aggregate incentive under 1886(n)(2)(D) of the Act, to determine fiscal year. Section 1886(n)(2)(C) of the different scenarios, considering that a the aggregate EHR amount allowable for Act provides the Secretary with Medicaid EP may initiate participation individual hospitals. The aggregate EHR authority to determine the discharge in 2011 through 2016. Additionally, hospital incentive amount is calculated related amount on the basis of discharge these tables do not include the using an overall EHR amount multiplied data from a relevant hospital cost alternative Medicaid maximum by the Medicaid share. The aggregate reporting period, for use in determining incentive payment for pediatricians EHR hospital incentive amount is the the incentive payment during a Federal discussed in the previous section, total amount the hospital could receive fiscal year. Federal fiscal years begin on which is two-thirds of the total amount in Medicaid payments over 4 years of October 1 of each calendar year, and listed in Tables 27 through 30. Finally, the program. end on September 30 of the subsequent these tables do not represent EPs whose States are responsible for using calendar year. Hospital cost reporting incentive payments may be reduced auditable data sources to calculate periods can begin with any month of a because net average allowable costs may Medicaid EPs’ aggregate EHR hospital calendar year, and end on the last day actually be lower than $25,000 in the incentive amounts, as well as of the 12th subsequent month in the first year, or $10,000 in subsequent determining Medicaid incentive next calendar year. For purposes of years, due to payments from other, non- payments to those providers. Auditable administrative simplicity and State/local sources. data sources include— timeliness, we propose that States, for • Providers’ Medicare cost reports; each eligible hospital during each b. Payment Methodology for Eligible • State-specific Medicaid cost reports; incentive payment year, use data on the Hospitals • Payment and utilization hospital discharges from the hospital Statutory parameters placed on information from the State’s MMIS (or fiscal year that ends during the Federal Medicaid incentive payments to other automated claims processing fiscal year prior to the fiscal year that hospitals are largely based on the systems or information retrieval serves as the payment year. methodology applied to Medicare systems); and • Example: FY 2011 begins on October 1, incentive payments. The specifications Hospital financial statements and 2010 and ends on September 30, 2011. For described in this section are limits to hospital accounting records. an eligible hospital with a cost reporting which States must adhere when All State Medicaid EHR incentive period running from July 1, 2010 through developing aggregate EHR hospital program calculations, payments, and June 30, 2011, we would employ the relevant incentive amounts for Medicaid-eligible limits under this section are subject to data from the hospital’s cost reporting period hospitals. States will calculate hospitals’ our review. ending June 30, 2010 in order to determine aggregate EHR hospital incentive For purposes of the Medicaid EHR the incentive payment for the hospital during incentive program, the overall EHR Federal fiscal year 2011. This timeline would amounts on the FFY to align with allow States to have the relevant data hospitals participating in the Medicare amount is equal to the sum over 4 years available for determining the aggregate EHR EHR incentive program. of (I)(a) the base amount (defined by hospital incentive amount in a timely States may pay children’s hospitals statute as $2,000,000); plus (b) the manner for the first and subsequent payment and acute care hospitals up to 100 discharge related amount defined as years. percent of an aggregate EHR hospital $200 for the 1,150th through the The discharge-related amount is $200 per incentive amount provided over a 23,000th discharge for the first payment discharge for discharges 1,150 through minimum of a 3-year period and a year (for subsequent payments years, 23,000. To determine the discharge-related maximum of a 6-year period. The States must assume discharges increase amount for the 3 subsequent payment years that are included in determining the overall maximum incentive amounts for these by the provider’s average annual rate of EHR amount, States should assume providers are statutorily defined by a growth for the most recent 3 years for discharges for an individual hospital have formula at section 1903(t)(5)(B) of the which data are available per year): increased by the average annual growth rate Act. The statute requires that Medicaid multiplied by (II) the transition factor for an individual hospital over the most

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recent 3 years of available data from an of the Act, which provides that in figure is deemed to equal 0. Likewise, if auditable data source. Note that if a hospital’s computing inpatient-bed-days, the there is simply not sufficient data for average annual rate of growth is negative over Secretary shall take into account the State to estimate the percentage of the 3 year period, it should be applied as inpatient-bed-days that are paid for inpatient bed days that are not charity such. individuals enrolled in a Medicaid We have provided a sample calculation for care (that is, [estimated total charges— review that assumes the following: managed care plan under sections charity care charges]/estimated total • An individual provider had 20,000 1903(m) or 1932 of the Act. We interpret charges), the statute directs that such discharges in the first FY (2011). these managed care individuals to be figure is deemed to equal 1. • The most recent annual growth data individuals enrolled in a managed care The aggregate EHR incentive available are as follows: organization (MCO), prepaid inpatient calculation for Medicaid eligible ++ FY 2005 (.028 annual growth rate) health plan (PIHP), or prepaid hospitals is represented mathematically ++ FY 2006 (.013 annual growth rate) ambulatory health plan (PAHP) under as follows: ++ FY 2007 (.027 annual growth rate) 42 CFR part 438. (Overall EHR Amount) * (Medicaid The average annual growth rate over 3 Some Medicaid managed care entities years = (.028 × .013 × .027)/3 = .0227. Share) or (that is, MCOs, PIHPs, and PAHPs with {Sum over 4 year of [(Base Amount + Year 1 risk contracts) provide substitute Discharge Related Amount 2011 discharge related amount equals: services (or, ‘‘in-lieu-of services’’) in Applicable for Each Year) * (20,000 ¥ 1149) × $200 = $3,770,200 more cost effective or efficient settings Transition Factor Applicable for than the State plan services in the Each Year]} * Year 2 managed care contract. For example, in {(Medicaid inpatient-bed-days + 2012 discharge related amount equals: a hospital inpatient setting, these × Medicaid managed care inpatient- 20,000 1.0227 = 20,454 services could be in a different unit, ¥ × = bed-days)/[(total inpatient-bed (20,454 1149) $200 $3,861,000 such as a subacute wing or skilled days) * (estimated total Year 3 nursing wing, so long as States and ¥ contracting entities are in compliance charges charity care charges)/ 2013 discharge related amount equals: (estimated total charges)]} 20,454 × 1.0227 = 20,918 with the actuarial soundness rules at 42 (20,918 ¥ 1149) × $200 = $3,953,800 CFR 438.6(c), provision of substitute To achieve the aggregate EHR hospital services is allowed. Although we incentive amount at 1903(t)(5)(a), the Year 4 understand that these substitute service calculation must be aggregated over 4 2014 discharge related amount equals: years. For further clarification, we have × days may be used to achieve efficiency 20,918 1.0227 = 21,393 and cost effectiveness, we do not believe provided a sample calculation of the (21,393 ¥ 1149) × $200 = $4,048,800 such substitute service days should aggregate EHR hospital amount. The overall hospital EHR amount requires Assume the following as constant that a transition factor be applied to each count as ‘‘inpatient-bed-days’’ in the year. This transition factor equals 1 for year hospital EHR incentive payment over 4 years except where noted: • 20,000 discharges (Note: This 1, 3⁄4 for year 2, 1⁄2 for year 3, and 1⁄4 for year calculation. The statute requires us to 4, as provided for in sections 1886(n)(2)(A) calculate the Medicaid share ‘‘in the calculation assumes the same averaging and 1886(n)(2)(E) of the Act, and as same manner’’ as the Medicare share data calculated in the average annual incorporated through section 1902(t)(5)(B) of under section 1886(n)(2)(D) of the Act growth example above.) the Act. We note that although, for purposes and such substitute service days would • 34,000 inpatient Medicaid bed-days of the Medicare incentives, section not be considered ‘‘in the same manner.’’ (including fee-for-service and managed 1886(n)(2)(E)(ii) of the Act requires a Thus, we propose that for purposes of care days) transition factor of 0, if the first payment year the Medicaid formula, we would count • 100,000 total inpatient bed-days is after 2013, we do not believe this rule • only those days that would count as $1,000,000,000 in total charges would apply in the context of the Medicaid • inpatient-bed-days for Medicare $200,000,000 in charity care incentive payments. Nothing in section • = 1903(t) of the Act specifically cross purposes under section 1886(n)(2)(D) of Overall EHR amount Sum (Year 1, references this 0 transition factor, and, the Act. Year 2, Year 3, Year 4) = $14,655,050 notably, section 1903(t) of the Act allows In addition, because the formula for Year 1: {$2,000,000 + ((20,000 ¥ 1,149) Medicaid incentive payments to begin as late calculating the Medicaid share requires × 200)} × 1 × 1 = $5,770,200 as 2016. a determination of charity care charges, Year 2: {$2,000,000 + ((20,454 ¥ 1,149) The ‘‘Medicaid Share,’’ against which States should use the revised Medicare × 200)} × 1 × .75 = $4,395,750 the overall EHR amount is multiplied, is 2552–10, Worksheet S–10 or another Year 3: {$2,000,000 + ((20,918 ¥ 1,149) essentially the percentage of a hospital’s auditable data source to determine the × 200)} × 1 × .50 = $2,976,900 { ¥ inpatient, non-charity care days that are charity care portion of the formula. In Year 4: $2,000,000 + ((21,393 1,149) × } × × attributable to Medicaid inpatients. the absence of sufficient charity care 200) 1 .25 = $1,512,200 × More specifically, the Medicaid share is data to complete the calculation, section Medicaid Share: 34,000/(100,000 a fraction expressed as— 1886(n)(2)(D) of the Act, requires the (($1,000,000,000—$200,000,000)/ • Estimated Medicaid inpatient-bed- use of uncompensated care data to 1,000,000,000) = 0.425 days plus estimated Medicaid managed derive an appropriate estimate of charity Overall EHR Amount × Medicaid Share care inpatient-bed-days; care, including a downward adjustment = Medicaid aggregate EHR incentive • Divided by; for bad debts. We interpreted bad debt amount $14,655,050 × 0.425 = • Estimated total inpatient-bed days to be consistent with the Medicare $6,228,396 multiplied by ((estimated total charges definition of bad debt as promulgated at Unlike Medicaid EPs, who must minus charity care charges) divided by 42 CFR 413.89(b)(1). waive rights to duplicative Medicare estimated total charges). Finally, per section 1886(n)(2)(D) of incentive payments, hospitals may As indicated in the above formula, the the Act, to the extent there is simply not receive incentive payments from both Medicaid share includes both Medicaid sufficient data that would allow the Medicare and Medicaid, contingent on inpatient-bed-days and Medicaid State to estimate the inpatient bed-days successful demonstration of meaningful managed care inpatient-bed-days. This attributable to Medicaid managed care use and other requirements under both is in keeping with section 1903(t)(5)(C) patients, the statute directs that such programs.

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The last year that a hospital may percent of the hospital’s aggregate included here. For example, this table begin receiving Medicaid incentive incentive payment. Likewise, over a 2- assumes that a hospital would payments is FY 2016. States must make year period, no Medicaid payment to a participate on a consecutive annual payments over a minimum of 3 years hospital may exceed 90 percent of the basis until the incentive is exhausted. and a maximum of 6 years. aggregate incentive. The purpose of Table 31 is to illustrate Additionally, in any given payment Table 31 demonstrates several the general timeline for Medicaid year, no annual Medicaid incentive scenarios for Medicaid hospitals. hospital incentives. payment to a hospital may exceed 50 However, there are other scenarios not

c. Alternative and Optional Early State SMHP. States should include an • For eligible hospitals, their CMS Implementation to Make Incentive additional attestation for providers Certification Number (CCN); Payments for Adopting, Implementing, assuring that they are not accepting • The remittance date and amount of or Upgrading Certified EHR Technology payment in any other State. any incentive payments made to an EP or eligible hospital. Unlike Medicare, Medicaid has no In order for us to approve a State for early implementation, we are proposing Participating States would be statutory implementation date for that a State would have an electronic responsible for transmitting this data to making EHR incentive payments. We system for provider registration capable CMS so that CMS can ensure that no believe that some States may be of collecting the relevant information duplicate payments will be made to prepared to implement their program identified in section II.A.5.c of this providers. We would use the single and make EHR incentive payments to proposed rule, where we describe the provider election repository described Medicaid providers in 2010 for data collection requirements. This in section II.A.5.c. of this proposed rule adopting, implementing, or upgrading includes the following: to assure no duplicative payments were certified EHR technology. We propose to made between States. • allow States to initiate implementation Name, National Provider Identifier We are not proposing that States of these payments to Medicaid EPs and (NPI), business address and business would be able to make early payments hospitals after promulgation of the final phone of each EP or eligible hospital; to meaningful users. This opportunity is rule if they successfully demonstrate to • Taxpayer Identification Number to intended to offer Medicaid providers an CMS that they are ready to make timely which the EP or eligible hospital wants early opportunity for capital so that they and accurate payments through the the incentive payment made; are more likely to have the certified EHR

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technology required to demonstrate While the Medicaid provisions have no demonstrate they have adopted, meaningful use in successive periods. statutory start date, before States may implemented, or upgraded certified EHR Since hospitals may qualify under both begin implementing the Medicaid EHR technology, as well as meaningful use of programs, we hope that they will use incentives, CMS, and ONC need to such EHR technology are proposed for the capital and qualify as a meaningful provide guidance to States in the form comment at section II.A.1.e of this user under the Medicare program in the of rulemaking and other policy preamble. As discussed in that section first year. We are requesting comments guidance. To that end, Medicaid will of this proposed rule, for the first on this proposed approach. not begin to provide 100 percent FFP for payment year (as well as the second incentive payments any earlier than FY payment year for those hospitals that are d. Process for Making and Receiving 2011 for hospitals and CY 2011 for EPs, able to begin receiving payments for FY Medicaid Incentive Payments (except in the case of incentive 2010), the reporting periods for eligible The process for making payments payments for adopting, implementing, hospitals will be on a continuous 90-day involves coordination between or upgrading, which could begin in basis, in the sense that as long as the Medicare and State Medicaid agencies 2010. See discussion in section start and end dates occur within the to avoid duplication of payments, II.D.4.b.(5).(c). of this proposed rule. payment year and as long as the period prevent fraud and abuse, and create This also gives CMS, ONC, and States spans the proposed 90-day consecutive program efficiencies to encourage an opportunity to coordinate between period, the period can begin at any time adoption. While we have responsibility Medicare and Medicaid, which we hope during the payment year. States will regarding payments to Medicare EPs will simplify administrative complexity then be expected to process payments, and hospitals, State Medicaid agencies in the EHR incentive program and also on a rolling basis. In the subsequent (or their contractors) are fully facilitate provider adoption. payment years, the reporting period will responsible for administering and We believe that by aligning the EHR be a full annual period (that is, a full disbursing the incentive payments to incentive programs where possible, payment period). Medicaid providers. Medicaid EHR incentive program We will require that EPs make a administration could be more efficient e. Avoiding Duplicate Payment selection between receiving incentive for the States, and provider At section 1903(t)(7) of the Act, the payments through either the Medicare communication about the program statute requires that the Medicare and or Medicaid EHR incentive programs. could be less ambiguous. This will be of Medicaid programs coordinate Medicaid EPs who practice in multiple particular benefit to the providers who payments to avoid duplication. This states will be required to choose only serve both Medicare and Medicaid section further specifies that CMS and one state from which to receive program beneficiaries, and will be the States should coordinate payments Medicaid incentive payments. The eligible for participation in both through a data matching process, issues related to these decisions are incentive programs. Also, we believe utilizing NPIs to the extent practicable. discussed here, as well as in section II.A that the incidence of fraud and abuse Additionally, section 1903(t)(2) of the of this proposed rule. could be curtailed, and the potential for Act states that Medicaid EPs must waive In this section, we describe the steps duplication of payments could be rights to Medicare incentive payments Medicaid EPs will take to receive an decreased. under sections 1848(o) and 1853(l) of incentive payment. Due to the inter- Under this proposed rule we are the Act. As previously noted, hospitals dependencies of multiple issues, we proposing that Medicaid EPs, as may qualify for incentives under both refer the reader to other sections of this discussed in section II.D.5 and II.A.5.c programs. We also propose proposed rule. Specifically, section II.A of this proposed rule, will enroll in the requirements under the review and of this proposed rule solicits comments program through the single provider approval of SMHPs in proposed part for a proposed reporting period in the election repository. Once an EP selects 495 subpart D for States to verify that first payment year of any continuous 90- the Medicaid EHR incentive program, providers meet these requirements. day period that starts and ends within we propose that States must have a As discussed in section II.A of this the calendar year. In addition, such 90- system for reporting and tracking proposed rule, we considered what day period would apply in both the first necessary information to qualify an EP information will be necessary to and second payments years (that is, for an incentive payment. In addition, as eliminate duplicative incentive 2010 and 2011) for States approved for detailed in § 495.316 States will be payments to providers between the early implementation in 2010. Section required to submit data to CMS Medicare and Medicaid programs. In II.A. also solicits comments on full including data for the number, type and order to ensure against duplicate annual reporting periods for all payment practice location(s) of providers who incentive payments, we believe three years other than the first payment year qualified for an incentive payment on conditions are required: (1) Knowing (except in the case of States approved the basis of having adopted, which EHR incentive program a for 2010 implementation, for which the implemented, or upgraded certified EHR provider has selected, (2) uniquely full annual reporting period would technology or who qualified for an identifying each provider participating begin in the third year). We also discuss incentive payment on the basis of in each incentive program; and (3) the proposed single provider election having meaningfully used such ensuring that each State has access to repository and other issues impacting technology as well as aggregate de- the information on which EPs or both programs. identified data on meaningful use. hospitals intend to receive incentive It is important to note that there is a States’ systems and processes will be payments from another State, or from very clear intent in the statute that there submitted by the States to CMS for prior the Medicare program. is coordination between the EHR approval, concurrent with the To achieve all three of these incentive programs to reduce or requirements described in section II.D.8 conditions, as discussed in section eliminate duplicate payments between of this proposed rule for review and II.A.5.c of this proposed rule, we Medicare and Medicaid. Additionally, approval of the SMHP. propose to collect this data in a single Medicare requirements under section The specific timeframes for EPs and provider election repository. Next, in 1848(o)(1)(B) of the Act require that eligible hospitals to report and submit administering each State Medicaid EHR payments begin no earlier than 2011. the required information in order to incentive program, we propose that

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States would cross-check for potential payments are made by one, or more than 7. Activities Required To Receive duplicative payments through the data one, State, we believe it would not be Incentive Payments available to them through the single worth the resulting administrative • a. General Overview. provider election repository, which is complexity to allow payments from As previously discussed, for Medicaid based on the NPIs. We believe that this multiple States. providers (including both EPs and coordinates with our proposed We considered the possible impact of eligible hospitals) to qualify to receive a requirements that a State must have an this proposed approach with respect to first year Medicaid incentive payment, approved SMHP which will include a patient volume calculations on section 1903(t)(6)(C)(i) of the Act mechanism for cross-checking this Medicaid EPs and hospitals in border indicates that the provider must information prior to payment. State areas. While we addressed the demonstrate that they are ‘‘engaged in f. Flexibility To Alternate Between administrative complexity of this issue efforts to adopt, implement, or upgrade Medicare and Medicaid EHR Incentive here, we recommend that States certified EHR technology.’’ For providers Programs One Time consider these border State providers who meet this standard in their first when developing their policies and year of participation in the Medicaid We refer readers to section II.A.5.b of attestation methodology. We afforded this proposed rule, where we discuss incentive program, in subsequent years additional flexibility in the patient of participation, they must then our proposal to allow Medicare and volume at proposed § 495.306 to Medicaid EPs to make one EHR demonstrate ‘‘meaningful use of certified account for unique circumstances and EHR technology through a means that is incentive program election change prior data collection. to 2015, and not to permit any switching approved by the State and acceptable to after the year 2014. Under such a 5. Single Provider Election Repository the Secretary,’’ and that may be based proposal, even if an EP initially received and State Data Collection upon the methods employed under the incentive payments under the Medicare Medicare incentive payments to We refer readers to section II.A.5.c of program, such an EP could still switch physicians and hospitals, per sections this proposed rule for a discussion of to the Medicaid program one time prior 1848(o) or 1886(n) of the Act. the single provider election repository. to 2015. Similarly, an EP who initially • b. Definitions Related to Certified As discussed in that section, the selected the Medicaid EHR incentive EHR Technology and Adopting, repository will collect a minimum program could switch to the Medicare Implementing or Upgrading Such amount of information on all EPs and program one time prior to 2015. Technology. hospitals to prevent duplicative g. One State Selection payments and coordinate technical (1) Certified EHR Technology We propose that for EPs and hospitals assistance. As noted previously, in order to with multi-state Medicaid practice 6. Collection of Information Related to receive a Medicaid incentive payment locations, that the provider may the Eligible Professional’s National the EHR technology must be ‘‘certified.’’ annually pick only one State from Provider Identifier and the Tax Section 1903(t)(3) of the Act defines which to receive incentive payments. In Identification Number ‘‘certified EHR technology’’ as a other words, a provider would not be qualified electronic health record (as able to receive incentive payments from Similar to the policy proposed where defined in section 3000(13) of the PHS more than one State in the same year. Medicaid EPs and hospitals must select Act) that is certified pursuant to section For example, a provider may be licensed one State, for those EPs in multiple 3001(c)(5) of the PHS Act as meeting to practice in Illinois as well as in Iowa, group practices or multiple types of standards adopted under section 3004 of particularly in the area known as the practice locations, we propose to require the PHS Act that are applicable to the Quad Cities because of the multiple such professionals to select one TIN for type of record involved (as determined cities in proximity to the Illinois and Medicaid EHR payment disbursement. by the Secretary), such as an ambulatory Iowa borders. There are numerous In other words, such EPs could not electronic health record for office-based situations like this throughout the require a State to divide payments physicians or an inpatient hospital country for States sharing borders. among different practices or practice electronic health record for hospitals). Medicaid EPs and hospitals may change locations based upon group TINs. In section I.A of this proposed rule, for the State that they select annually when Requiring EPs to use only one TIN both Medicare and Medicaid, we they re-attest to the program would reduce administrative discussed incorporating ONC’s requirements. complexity, as it would ensure that definition of certified EHR technology. Since qualifying for the Medicaid States are not put in the position of incentive payments is not a claims dividing payments in any way an EP (2) Adopting, Implementing or accrual process, as it is in Medicare, requests (such as by patient encounters Upgrading allowing providers to include multiple or amount contributed to EHR Unlike the Medicare incentive practice sites across State boundaries technology). We also believe that programs, the Medicaid program allows would create enormous administrative requiring reimbursement to be made to eligible providers to receive an complexity for both CMS and State one TIN would reduce opportunities for incentive payment even before they Medicaid agencies. For example, States fraud or abuse, as States will be able to have begun to meaningfully use would have to collect and verify cross-check EP and TIN combinations certified EHR technology. These Medicaid patient volume across more more easily to verify EP attestations. providers may receive a first year of than one State, then divide and Although the State would not divide payment if they are engaged in efforts to administer payments based on a payments among the various TINs of an ‘‘adopt, implement, or upgrade’’ to methodology suitable between the State individual EP, Medicaid EPs could certified EHR technology. In proposed Medicaid agencies and the providers. decide to divide payment themselves, § 495.302, we define adopting, Given that the providers qualifying for and distribute funds among their implementing or upgrading certified the Medicaid incentive program will respective group practices or practice EHR technology as the process by which receive the same incentive payment locations after the initial disbursement providers have installed and dollar amount regardless of whether from the State to their designated TIN. commenced utilization of certified EHR

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technology capable of meeting tangible adoption, implementation, or Medicaid EPs participating in the meaningful use requirements; or upgrading of certified EHR technology. Medicaid EHR incentive program. As expanded the available functionality In establishing criteria for the discussed previously, the reporting and commenced utilization of certified ‘‘implementation’’ portion of ‘‘adopt, period is significant for EPs and eligible EHR technology capable of meeting implement or upgrade’’ requirement, we hospitals because it will define the meaningful use requirements at the are proposing that ‘‘implementation’’ period during which the provider must practice site, including staffing, mean that the provider has installed establish efforts to adopt, implement, or maintenance, and training. certified EHR technology and has upgrade certified EHR technology, or For the purposes of demonstrating started using the certified EHR demonstrate meaningful use of, such that providers adopted, implemented, or technology in his or her clinical technology. The reporting period also is upgraded certified EHR technology, practice. Implementation activities significant for States, because States will Medicaid EPs and hospitals would have would include staff training in the refer to such reporting periods in to attest to having adopted, (that is, certified EHR technology, the data entry assuring us that providers are eligible to acquired and installed) or commenced of their patients’ demographic and participate in the Medicaid EHR utilization of (that is, implemented) administrative data into the EHR, or incentive program. (Requirements certified EHR technology; or expanded establishing data exchange agreements relating to the components that must be (that is, upgraded) the available and relationships between the included in the SMHP are specified in functionality of certified EHR provider’s certified EHR technology and proposed § 495.354). States will need to technology and commenced utilization other providers, such as laboratories, refer to the providers’ reports of the at their practice site. States would be pharmacies, or HIEs. activities that establish their efforts to responsible for ensuring that processes In establishing the criteria for the adopt, implement, or upgrade certified ‘‘ ’’ ‘‘ are in place to verify that providers have upgrade portion of adopt, implement EHR technology. Similarly, once ’’ actually adopted, implemented or or upgrade requirement, we propose meaningful use of EHR technology is ‘‘ ’’ upgraded certified EHR technology, upgrade to mean the expansion of the required to include the reporting of functionality of the certified EHR patient volume, as well as other clinical quality measures, States will technology, such as the addition of requirements in this section, including need to ensure such measures are clinical decision support, e-prescribing verifying that attestations are consistent reported in accordance with the functionality, CPOE or other with methodologies to combat fraud and appropriate period. States could not enhancements that facilitate the abuse (see proposed § 495.366 through appropriately make incentive payments meaningful use of certified EHR 370, Financial Oversight, Program in the absence of such reporting. technology. States must describe the Integrity, and Provider Appeals). The As discussed in section II.A of this process that would be in place in the proposed rule and elsewhere in this State’s SMHP must detail these SMHP for ensuring that providers have section, we propose that the EHR processes. actually adopted, upgraded or reporting period would occur on a The CMS Medicaid Transformation implemented certified EHR technology. rolling basis during the first payment Grants have demonstrated the many We encourage States to consider the year (and also in 2010 for States challenges that exist to adopting EHR submission of a vendor contract from approved for early implementation). For technology. EHR system availability is providers to ensure the existence of EHR subsequent payment years, the EHR not the same as EHR system utilization. technology. reporting period will be on an annual It is for that reason that we propose to In listening sessions with State basis (that is, for the entire payment include staff training and efforts to Medicaid Agencies’ staff and Governors’ year). redesign provider workflow under the offices staffs, States suggested verifying States would be required to validate definition of implementing certified providers’ adoption, implementation, or to us that the Medicaid EPs and EHR technology. Success is not simply upgrading of certified EHR technology hospitals meet all of the eligibility defined by the acquisition and through system enhancements that track criteria to qualify for Medicaid incentive installation of new or upgraded certified and audit providers’ written or payments, including the applicable EHR technology, but more importantly electronic attestations, through surveys, patient volume thresholds, hospital- by providers demonstrating progress or through new claims codes that would based requirements, and all of the towards the integration of EHRs into serve as attestations. Additional requirements described in this section. their routine health care practices to suggestions from State staff included States would develop their own improve patient safety, care, and using EHR vendor audit logs for administration, payment and audit outcomes. Medicaid EPs rendering service through processes, and as described in In establishing criteria for the the FQHCs and tracking EHR reporting § 495.332, we would require that States ‘‘adoption’’ portion of the ‘‘adopt, of the Health Resources and Services include in their SMHPs how they would implement, or upgrade’’ requirement, we Administration (HRSA)-mandated obtain Medicaid EPs’ and hospitals’ propose that there be evidence that a quality indicators. More information on attestations of eligibility to qualify for provider demonstrate actual installation feedback received as a result of these the Medicaid incentive payments. prior to the incentive, rather than listening sessions can be found in Permissible means for ensuring patient ‘‘efforts’’ to install. This evidence will section II.A. of this proposed rule. These volume and all of the requirements serve to differentiate between activities suggestions may be relevant to the described in this section include survey, that may not result in installation (for discussion below concerning the States attestation, or the creation of special example, researching EHRs or process for developing a SMHP, codes on claims, subject to our prior interviewing EHR vendors) and actual verifying attestations and ensuring that approval. purchase/acquisition or installation. It is providers are eligible to participate in Additionally, we may require a more the States’ responsibility to verify this the incentive payments program. robust method for ensuring compliance evidence of EHR adoption. As these with the requirements listed in this Medicaid incentive payments are c. Other General Terminology section beyond attestation as this intended to stimulate meaningful use of ‘‘EHR reporting period’’ and ‘‘payment program matures. Therefore, we are EHR technology, they need to result in period’’ relate to the requirements for soliciting comments, including the

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impact that an alternative method may specific definition of ‘‘meaningful use’’ work to connect the tools and have on providers and States if an in section II.A.2. of this proposed rule infrastructure developed under their alternative method that is not attestation is what providers must demonstrate to Federal grant funds with providers’ is required. the States, and what States must track efforts to adopt, implement, and Section 1903(t)(6)(C)(ii) of the Act and validate. States wishing to ask upgrade certified EHR technology and to also indicates that in the case of an early providers to demonstrate additional become meaningful users of certified adopter, that is, a Medicaid EP or objectives to the definition of EHR technology. We would be eligible hospital that has already ‘‘meaningful use’’ as noted in this evaluating States’ HIT Planning adopted certified EHR technology, such proposed rule would need to request Advanced Planning Documents (PAPDs) provider would receive payment in the our prior approval of such a revised and SMHP with this objective in mind, first year and all subsequent years of the definition in their SMHP, as described as described section II.D.8 of this incentive program by demonstrating in section II.D.8 of this proposed rule. proposed rule. meaningful use. In other words, such a We do not wish to see the bar for provider would not need to demonstrate demonstration of meaningful use set so The requirements to which States that it has adopted, implemented, or high, especially in the early years of this would hold eligible Medicaid providers upgraded certified EHR technology in program that, it becomes a deterrent for accountable would vary based upon the year one of the program, if they can broad provider participation. Examples number of years an eligible Medicaid already demonstrate meaningful use of of how States may consider adding to provider participates in the program. In such technology. In the case of the Federal definition of meaningful use other words, regardless of the calendar Medicaid EPs, we discuss our proposal include requiring providers to year, a provider’s first year as a approach to paying early adopters in participate in a health information participant in the Medicaid EHR section II.D.4.5. exchange, and requiring that providers incentive program is when that provider It is expected that the bar for link to immunization, lead screening, or must demonstrate either adoption, demonstrating meaningful use of newborn screening registries. These implementation, upgrading or certified EHR technology will rise in mechanisms must be readily available to meaningful use of certified EHR years to come, as discussed in section providers, and not represent a financial technology. States’ systems must be able II.A. States have offered their burden for participation. For example, to track providers’ year of entry into the suggestions to us as to how they would States are discouraged from proposing Medicaid EHR incentive program to verify providers’ meaningful use of additional meaningful use measures that determine the correct eligibility criteria certified EHR technology, including would require providers to assume and generate the appropriate Medicaid participation in the exchange of clinical additional financial costs in order to incentive payments. and administrative data; National qualify to participate in the Medicaid In Table 32, we depict the Committee for Quality Assurance EHR incentive program. requirements for eligible Medicaid (NCQA) certification as an advanced States should carefully consider how professionals and hospitals that either medical home (which includes an EHR to build upon their existing EHR adopt, implement, or upgrade certified requirement); e-prescribing, and activities and infrastructure without EHR technology or that move directly to conducting security and privacy audits. deterring eligible Medicaid providers meaningful use of such technology. Many of these elements are discussed in from participating by compelling them Additionally, we refer readers to Table the definition of ‘‘meaningful use’’ noted to use a particular system. We 1 since the table references the stages of in section II.A.2. of this proposed rule. encourage States that were awarded meaningful use. Readers may find this For purposes of participation in the Federal HIT/EHR grants, such as the information helpful when considering Medicaid EHR incentive program, the Medicaid Transformation Grants, to the information in Table 32.

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As previously noted, States would be discontinued funding or disallowances. proposed in II.A.3 of this proposed rule, required to verify providers’ meaningful See the discussion below regarding the additional clinical quality measures that use of certified EHR technology. We also SMHP and the State reporting could be used by Medicaid providers to expect to test the reporting of additional requirements. We would use the States’ meet the quality reporting aspect of clinical quality measures that may be reports, including data on meaningful meaningful use. These additional used in future definitions of meaningful use and clinical quality measures, in indicators address key Medicaid use. States may wish to participate in order for the Secretary to fulfill her services, such as pediatrics, obstetrical/ this testing and seek out eligible responsibilities to Congress under gynecologic, mental health and Medicaid providers to report on specific section 1903(t)(10) of the Act. This substance abuse services. Medicaid clinical quality measures, extractable provision requires that the Secretary providers could report on these clinical from EHRs. States would be able to use report to Congress on the improvement quality indicators in lieu of the quality this reporting to pilot-test requirements of health outcomes, clinical quality, or indicators that are listed in Table 3. We that could be included in future efficiency as a result of implementing recognize that quality measures definitions of meaningful use. this program. For hospitals eligible for associated with the Stage 1 definition of Once States are giving providers the both Medicare and Medicaid EHR meaningful use contain certain gaps for Medicaid HIT incentive payments for incentive programs, where hospitals are being meaningful users of EHRs, and reporting meaningful use measures to Medicaid providers, including in the starting in 2012 are collecting those CMS, we will make quality data on areas of oral health, long-term care, providers’ clinical quality measures Medicaid eligible hospitals available to newborn screening, and other areas of data, States will be required to share any States. pediatric care. As discussed previously, such reported data with CMS in an we intend to update our definition of aggregated, de-identified manner, on an d. Quality Measures meaningful use biannually, and we annual basis. The timetable and format We refer readers to section II.A.3 of expect that our updated, Stage 2 for sharing the clinical quality this proposed rule for a discussion of definition would include additional measurement data would be provided to the clinical quality measure reporting Medicaid clinical quality measures to be States in future policy guidance issued required for demonstrating meaningful reported from EHRs. We intend to work by CMS. States’ failure to submit these use of certified EHR technology. As with the quality measurement required reports to us could result in discussed in that section we have community to develop these Stage 2

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quality measures (see section II.B.1.d. of health information technology other functions, such as eligibility this proposed rule). equipment or services for the purpose of determination. implementation and administration of We are defining the ‘‘Medicaid 8. Overview of Conditions for States To the provisions under this proposed rule Management Information System’’ as it Receive Federal Financial Participation from commercial sources or from State relates to the mechanized claims (FFP) for Incentive Payments and or local government resources. We processing systems at 42 CFR 433, Implementation Funding define and utilize this term in the Subpart C, since this term has not Section 1903(a)(3)(F) of the Act context of HIT planning and previously been codified in regulations provides that States are eligible for 100 implementation activities that will and we are requiring that in percent FFP for direct payment enable States to implement existing implementing this program under the expenditures to certain Medicaid EPs Federal requirements for competitive authority of section 1903(t)(6)(D) of the and eligible hospitals to encourage the procurement of equipment or services. Act, certified EHR technology must be adoption and use of certified EHR • Service Oriented Architecture: The compatible with the MMIS. technology. States are also eligible for term ‘‘service oriented architecture’’ is Additionally, we expect States would 90 percent FFP for reasonable defined in this proposed rule as a means align their Medicaid EHR initiatives administrative expenses, contingent on of organizing and developing with those envisioned under MITA, in State compliance with the following information technology capabilities as order to fully support the meaningful requirements: (1) Using the funds to collaborating services that interact with use of EHR envisioned under this new administer Medicaid incentive each other based on open standards. We program. As part of their SMHP, States payments for certified EHR technology, are defining this term in the context of will be required to map different IT including tracking of meaningful use by HIT projects authorized under the solutions to their existing Medicaid Medicaid EPs and eligible hospitals; (2) HITECH Act to ensure that different enterprise business requirements using conducting oversight of the Medicaid systems and programming languages the MITA business areas and processes EHR incentive program, including provide the basis for interoperability list when preparing a baseline State self- routine tracking of meaningful use among and between applications that assessment. Using the MITA State self- attestations and reporting mechanisms; may reside on different platforms assessment provides a baseline that will and (3) pursuing initiatives to encourage through a communication protocol to facilitate collaboration between the the adoption of certified EHR achieve health information exchange States and CMS, between the State and technology for the promotion of health required under ARRA. industry and among the States care quality and the exchange of health • State Self-Assessment: The term themselves. The MITA ‘‘State self- care information. ‘‘State self assessment’’ uses a standard assessment’’ process uses a standard This section of the proposed rule methodology and tools to document the methodology and tools to document the discusses the requirements for States to way a State conducts business now and way a State conducts business now, and request FFP from CMS for the Medicaid plans to conduct business in the future. plans to conduct business in the future. EHR incentive program. Additionally, • Medicaid information technology The purpose of the SMHP is to identify this section is closely connected to the architecture (MITA) is both an initiative the ‘‘As Is’’ state and ‘‘To Be’’ (target) requirements outlined in Financial and a framework. It is a national state of a State’s Medicaid business Oversight, Program Integrity and framework to support improved systems enterprise and to align business areas Providers Appeals for purposes of development and health care and processes in the user community. oversight and accountability. management for the Medicaid Once this alignment is complete, States In proposed § 495.302, we define enterprise. It is an initiative to establish may then add other Medicaid business terms used in the Medicaid subpart of national guidelines for technologies and processes by extending the MITA model the regulations governing State requests processes that enable improved program during implementation to ultimately for FFP. Although some of these terms administration for the Medicaid facilitate the EHR program. The State have been defined in other portions of enterprise. The MITA initiative includes self-assessment would help to identify our regulations, for ease of reference, an architecture framework, models, duplicative and overlapping business and in order to define the terms in this processes, and planning guidelines for areas and processes and to identify gaps specific context, we have separately enabling State Medicaid enterprises to by adopting new business areas and included definitions in part 495. Other meet common objectives with the processes needed to complete the EHR terms such as ‘‘HIT PAPD,’’ ‘‘IAPD,’’ framework while supporting unique enterprise. Using an incremental ‘‘SMHP’’ are new terms which would be local needs. approach and setting achievable goals used in approving State plans for FFP. • Medicaid management information for the near and mid term, would help • Acceptance Documents: The term system (MMIS) means a mechanized the State assess its progress and identify ‘‘acceptance document’’ refers to written claims processing and information targets of opportunity critical to evidence of satisfactory completion of retrieval system—referred to as achieving the long-term ‘‘To Be’’ vision an approved phase or work or contract Medicaid Management Information for HIT by 2014. related to information technology Systems (MMIS)—that meets specified Further, the Medicaid enterprise is projects for which approved Federal requirements and that the Department comprised of internal and external funding is utilized. The term is has found (among other things) is communities of common business areas commonly used in information compatible with the claims processing that share an interest in seeing that the technology projects and is defined in and information retrieval systems used mission and goals of the Medicaid this proposed rule to ensure that we are in the administration of the Medicare program and improved health outcomes able to receive information from the program. The objectives of the MMIS are are achieved. These communities State necessary to evaluate and monitor to include claims processing and include the EPs and hospitals that the progress of HIT projects requested or retrieval of utilization and management would be receiving incentive payments. approved under this proposed rule. information necessary for program MITA’s principles and tools fosters • Acquisition: The term ‘‘acquisition’’ administration and audit and must nationally integrated business and IT is defined in this proposed rule to coordinate with other mechanized transformation. It does this by indicate a State’s intent to acquire systems and subsystems that perform demonstrating that planned

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enhancements support State and be integrated with existing State involve further development and full Medicaid strategic goals and how intra- resources to achieve these goals. implementation of the SMHP. state systems other than the MMIS have We provided guidance in a State Consequently, we would be requiring been considered in developing the Medicaid Director’s letter on September the HIT IAPD as the vehicle for solutions. By documenting the analysis 1, 2009, on this process and the State reporting of Phase II activities. We are of alternative solutions, particularly a efforts necessary to receive the 90 also proposing to require a prior review of solutions in other States or a percent FFP. As previously noted, as approval process, and anticipate that description of data sharing components States begin the process of developing States would work closely with us in and the reasons to include them or their SMHPs, they also can begin to developing the HIT PAPD prior to exclude them at this time can then be receive the 90 percent FFP funding initiating EHR planning activities and considered in its solution. immediately to be used to support their prior to submission of the initial HIT As such, the MITA process establishes initial EHR planning activities. For PAPD. State collaboration with us prior the guidelines necessary for EHRs example, initial planning regarding the to initiating submission of these implemented as a result of the Medicaid design and development of the documents would assist States in EHR incentive program to be anticipated SMHP may be eligible for understanding all of the requirements interoperable with State Medicaid the 90 percent FFP as an expense and would help us understand the systems, and we believe that as States related to the administration of the State’s strategy and plans which would and providers implement EHRs, it is Medicaid incentive payments under lead to a more effective implementation. essential to plan technology upgrades section 1903(a)(3)(F) of the Act and, In addition, such coordination would that would facilitate health information more broadly, for promoting health facilitate improved understanding of exchange with Medicaid providers information exchange. Our review existing State EHR planning and receiving incentive funding. process would ensure that States are implementation efforts in progress that • State Medicaid Health Information complying with requirements in the should be combined with this effort Technology Plan (SMHP) means a Act, and that they demonstrate to the (that is, health information exchange, document that describes the State’s ‘‘satisfaction of the Secretary’’ that they EHR demonstration, and Medicaid current and future HIT activities in are using the funds in the manner Transformation Grants). support of the Medicaid EHR incentive anticipated by the law; for example, Also, States would be required to program. because of our oversight responsibilities obtain prior written approval of • Health Information Technology simply proposing activities does not funding, planning documents, proposed Planning Advance Planning Document ensure the 90 percent FFP. We would budgets, project schedules, and certain (HIT PAPD) (and any necessary update review and prior approve all elements of implementation activities that a State documents) means a plan of action that the State’s SMHP, and APD documents. may wish to pursue in support of the requests FFP and approval to States would be required to submit Medicaid EHR incentive program to accomplish the planning necessary for a these advance planning documents in encourage the adoption and use of State agency to determine the need for order for us to approve receipt of the 90 certified EHR technology in line with and plan the acquisition of HIT percent Federal match. Specifically, the 90 percent FFP available to States. equipment or services or both and to prior approval would be required for the To minimize the burden on States, these acquire information necessary to HIT PAPD (see also § 495.336). The prior approval conditions, and the prior prepare a HIT implementation advanced deliverable resulting from the HIT PAPD approval process, would mirror that planning document or request for would be the SMHP. The SMHP would presently used in support of acquiring proposal to implement the State be reviewed and approved before it is automated data processing equipment Medicaid HIT Plan. included in an Implementation APD and services in conjunction with • Health Information Technology (IAPD) (see also § 495.338). The IAPD development and operation of State Implementation Advance Planning also must be prior approved. Until MMIS, or the State’s automated Document (HIT IAPD) (and any approval is granted States cannot draw mechanized claims processing and necessary update documents) means a down funds. The APD process allows information retrieval system approved plan of action that requests FFP and States to update their APD when they by CMS. approval to acquire and implement the anticipate changes in scope, cost, In considering the States’ strategies proposed State Medicaid HIT Plan schedule, etc. This allows States to add for adoption of EHR and health services or equipment or both. additional tasks to the contract which information exchange, current efforts To qualify to receive FFP for they may have not thought of at the time such as the State MMIS or automated administering the incentive program, the HIT PAPD was written, as they mechanized claims processing and States must develop a SMHP, an HIT worked through the original tasks on the information retrieval system, contain a PAPD, and an HIT IAPD. These original submission. Something as great deal of claims data and other documents would lay out the process complex as this will most likely result Medicaid programmatic information. States will use to implement and in an ‘‘as needed’’ and ‘‘annual’’ update The State MMIS can be of significant oversee the EHR incentive program, and to the original scope of work. value in analyzing the State’s current would help States to construct an HIT For purposes of the Medicaid EHR position and moving the State forward roadmap to develop the systems incentive program, we envision two to using certified EHR technology to necessary to support providers in their high-level phases in the process of promote health information exchange, adoption and meaningful use of planning and implementing the enhance quality, and improve health certified EHR technology. The incentive program, as well as the care outcomes. Additionally, the MITA development of a SMHP (see also promoting the adoption of EHR. Phase framework provides a conceptual model § 495.332) provides States with the I would include initial planning, for building capacity in Medicaid EHR opportunity to analyze and plan for how including an assessment of the State and health information exchange. EHR technology, over time, can be used EHR environmental landscape, and We are also proposing that State to enhance quality and health care development of the SMHP. The vehicle Medicaid programs must comply with outcomes and reduce overall health care for informing us of Phase I activities current procurement standards. costs. The uses of EHR technology can will be the HIT PAPD. Phase II will Specifically, we are including language

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in this proposed rule in accordance with hospital directly (or to an employer or 9. Financial Oversight, Program the procurement requirements in 45 facility to which such Medicaid EP or Integrity and Provider Appeals CFR Part 95 Subpart F to incorporate eligible hospital has assigned their Pursuant to section 1903(t)(9) of the much of the procurement standards Medicaid incentive payments) without Act, which requires States to conduct previously contained in 42 CFR Part 74. any deduction or rebate, and that States adequate oversight of the incentive Inclusion of these procurement would attest that payments to an entity program, and in order to ensure that requirements maintains the long- promoting the adoption of certified EHR ARRA funds are expended wisely and standing procurement standards and technology, as designated by the State, in a manner that impedes waste, fraud policies for State information would only be made if participation in or abuse of Federal taxpayer money, at technology contracts, as well as such a payment arrangement is § 495.366, we propose requirements for incorporate procurement standards voluntary for the Medicaid EP involved, States’ financial oversight and under the authority of section 1902(a)(4) and if such entity does not retain more monitoring of expenditures. of the Act, specifically for the definition than 5 percent of such assigned Additionally, we are proposing at of sole source justification, requiring all Medicaid incentive payments for costs § 495.368 to provide State requirements procurement transactions to be not related to such technology. States for combating fraud and abuse. conducted in a manner to provide, to would be required to attest that the Specifically, States would be the maximum extent practical, open and entire incentive payment has been responsible for estimating the free competition and promote the forwarded to the eligible Medicaid expenditures for the Medicaid EHR administration of the Medicaid program provider, and that no eligible Medicaid incentive program on the State’s in a cost effective manner. This provider is required to return any quarterly budget estimate reports. These proposed rule also addresses grantee portion of the incentive payment to the reports are used as the basis for responsibilities, codes of conduct, State Medicaid agency. We expect States Medicaid quarterly grant awards that competition, procurement procedures, to consider utilizing all existing fiscal would be advanced to the State for the and access to records that are specific to relationships as intermediaries for Medicaid EHR incentive program. The the HIT requirements envisioned under disbursing the incentives. Since many State submits this Form electronically to the ARRA. Also, under the authority of States never pay the provider directly, CMS via the Medicaid and State CHIP section 1902(a)(4) of the Act, we are but rather pay a managed care plan, Budget and Expenditure System (MBES/ proposing contracting requirements, which then pays the provider, the State CBES). At the end of the quarter, the reporting requirements, systems of may have no existing relationship and State would be responsible for records access, software and ownership decide to contract with the managed submitting expenditures to us via the rights, and rules for charging equipment care plan to pass this incentive to the MBES Form CMS–64. The Form CMS– 64 is the accounting statement that the and cost allocation plans. All of these EP. States must establish a process to State Agency, in accordance with 42 efforts would work to provide clarity for ensure that any existing fiscal CFR 430.30(c), submits each quarter States when considering planning and relationships with providers to disburse under Title XIX of the Act. The form is implementation activities, and would the Medicaid incentive payments used to reconcile the Medicaid funding also ensure that we are providing through Medicaid managed care plans advanced to the State for the quarter necessary direction for States in does not result in payments that exceed made on the basis of the CMS–37, with completing their HIT PAPD, HIT IAPD, 105 percent of the capitation rate, in actual expenditures for the quarter. It and SMHP. We are proposing under the order to comply with the Medicaid accounts for any overpayments, authority of 1902(a)(4) of the Act to managed care incentive payment rules at § 438.6(c)(5)(iii) and a methodology underpayments, refunds received by the establish requirements for termination State Medicaid agency, and income of FFP in the case of States failing to for verifying such information. Additionally, we are proposing that earned on grant funds. States must provide access to information relating to termination of funding approved under assure that requests for reimbursement any of the requirements of this subpart. this proposed Part 495 subpart D or of FFP comply with all sections of this Additionally, under section 1903(t)(10) disallowance of FFP may result if the new part and that the amounts reported of the Act, we are required to monitor State fails to meet the requirements and on the Form CMS–64 and its and report on the progress of undertakings of the approved PAPD, attachments represent actual implementation of the EHR provisions. SMHP, and IAPD, or fails to provide expenditures for which all supporting These proposed provisions would access to the required information. documentation, in readily reviewable contribute to the overall effort in Since section 4201 of the HITECH Act form, has been compiled and which is monitoring implementation efforts and amends section 1903(a)(3) of the Act to available at the time the claim for provide relevant information to provide for 90 percent FFP for costs reimbursement of provider payment Congress and the public at large. associated with certain administrative incentives and administration funding Consistent with our oversight activities performed by a State, we also is filed. responsibilities, we are also proposing are proposing to allow for claiming of We would assure that State to provide a framework for attestations. such reasonable costs incurred on or expenditures claimed for Federal Specifically, in section II.D.7 of this after February 18, 2009, prior to matching under the Medicaid program proposed rule, we discuss that we publication of the final rule. are programmatically reasonable, would require that providers attest to Specifically, if a State can show that it allowable, and allocable in accordance their efforts to adopt, implement or has begun the initial planning stages of with existing Federal laws, regulations, upgrade certified EHR technology, and moving the State in the direction of and policy guidance. CMS’ Regional attest to their meaningful use of such meaningful use of certified EHR Office financial and auditing specialists technology. In this section, we discuss technology through such activities as will be responsible for monitoring State our proposal that State Medicaid training efforts, staff support, or funding issues including the funding agencies would attest, as outlined in contracting with a vendor, we may related to these Medicaid EHR payment section 1903(t)(6)(A)(i) of the Act, that allow for retroactive FFP back to the incentives. Funding specialists would States would make Medicaid incentive date in which these efforts began, but also review the flow of funds to payments to a Medicaid EP or eligible not before February 18, 2009. determine that State funds are from

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allowable sources and to insure that Act, requiring that a State demonstrate A. ICRs Regarding Demonstration of Medicaid payment incentives would be to the satisfaction of the Secretary that Meaningful Use Criteria (§ 495.8) paid without reduction or rebate. it is conducting adequate oversight of In § 495.8(a)(1), we propose that to Additionally, funding specialists would the program, we are also proposing to demonstrate meaningful use for CY ensure that no other sources of funding establish § 495.370, Provider Appeals. 2011, an EP must attest, through a are used to make Medicaid EHR This proposed section would specify secure mechanism in a specified payment incentives to providers other that Medicaid providers who believe manner, to the following: (1) During the than State and local government funds. that they have been denied an incentive EHR reporting period, the EP used States would be responsible for payment or have received an incorrect certified EHR technology and specify establishing policies, computer systems, payment amount under this part the technology used; and (2) during the edits to process Medicaid EHR incentive because of incorrect determinations of EHR reporting period, the EP satisfied payments; and for conducting analyses eligibility, including, but not limited to, each of the applicable objectives and of providers’ patterns of practice (data- measuring patient volume; associated measures under § 495.6 mining) and taking other reasonable demonstrating meaningful use of, or the (including quality measures). The EP steps to ensure that no duplicate or efforts to adopt, implement, or upgrade must specify the EHR reporting period otherwise improper EHR incentive to, certified EHR technology; whether and provide the result of each payments have been made. States will the professional is hospital-based; applicable measure for all patients seen be responsible for ensuring that whether the professional is practicing during the EHR reporting period for provider information, including but not predominantly in an FQHC or RHC; which a selected measure is applicable. limited to, attestations, survey, and any whether the hospital qualifies as an We estimate that the certified EHR information added to CMS’ single acute care or children’s hospital; or technology adopted by the EP will provider election repository indicates whether the provider is already capture many of the Meaningful Use that any falsification of documentation participating in the Medicare incentive objectives and associated measures and or concealment of material facts may be program and therefore ineligible generate automated numerator and prosecuted under Federal and State duplicate Medicaid incentive program denominator information, where laws. States would be responsible for payments can appeal the decision using required, or automated summary recovering and returning to CMS FFP current Federal processes established at reports. Therefore, for these objectives for any HIT incentive payments that are 42 CFR 447.253(e). discovered to be improper. State and associated measures (Set A), we Agencies must have information III. Information Collection estimate that it would take no more than processing systems, including a MMIS— Requirements 0.5 hours for an EP to attest to them collectively as the EHR would be able to the automated mechanized claims Under the Paperwork Reduction Act processing and information retrieval gather all of the information necessary of 1995, CMS is required to provide 60- for the provider. For objectives and system, to process Medicaid EHR day notice in the Federal Register and incentive payments. MMIS systems can associated measures requiring a solicit public comment before a also help to manage information for numerator and denominator we limit to collection of information requirement is program administration and audit actions taken in the presence of certified submitted to the Office of Management purposes. EHR technology. We do not anticipate States must assure that any requests and Budget (OMB) for review and that an EP or eligible hospital will for reimbursement of the 90 percent approval. In order to fairly evaluate maintain two record keeping systems Federal match for administration of the whether an information collection when certified EHR technology is program are being requested only should be approved by OMB, section present. Therefore, we assume that all because the State has used the funds for 3506(c)(2)(A) of the Paperwork patient records that would be in the purposes related to administering Reduction Act of 1995 requires that denominator would be kept using payments to qualified Medicaid CMS solicit comment on the following certified EHR technology. Because providers for certified EHR technology, issues: generating this automated information including for tracking of meaningful use • The need for the information requires the purchase of a certified EHR of such technology, is conducting collection and its usefulness in carrying with the requisite technical adequate oversight of the program out the proper functions of our agency. functionality, reporting these measures including routine tracking of • The accuracy of our estimate of the will incur significant capital costs. meaningful use attestations and information collection burden. However, there are still some Meaningful Use objectives and reporting mechanisms; and is pursuing • The quality, utility, and clarity of initiatives to encourage the adoption of associated measures (Set B) where the information to be collected. reporting may require EPs to manually certified EHR technology to promote • health care quality and the exchange of Recommendations to minimize the gather the information necessary to health care information because of such information collection burden on the report numerators and denominators or technology. Any initiatives for health affected public, including automated to take any other additional steps before information exchange must be collection techniques. attesting that the objective has been met, consistent with Federal laws and The following is a discussion of the we have estimated that it would take 1 regulations governing the exchange. requirements we believe are subject to hour for the EP to gather that We would monitor State Agency PRA and collection of information information and report the result. For compliance through systems requirements as a result of this proposed example, the measure ‘‘At least 80 performance reviews, on-site reviews, rule. The projected numbers of EPs and percent of all patients who request an and audits of the APD process. eligible hospitals, MA organizations, electronic copy of their health As a result of the authority extended MA EPs and MA-affiliated hospitals are information are provided it within 48 to the Secretary under section 1902(a)(4) based on the numbers used in the hours’’ requires EPs to not only provide of the Act requiring the effective and Impact Analysis Assumptions as well as that information (a third-party efficient administration of the State in Table 45 in the Regulatory Impact disclosure) but also attest to the plan, as well as section 1903(t)(9) of the Analysis section. provision of that information for 80

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percent of all patients who request that to enable the tracking of all orders, (‘‘Set A’’) and those objectives and information. Another example is the whether entered using CPOE or associated measures which we estimate CPOE measure. The numerator for the otherwise, in which case reporting will take 1 hour each (‘‘Set B’’). We CPOE measure could be generated by burden may be less than an hour but the welcome comments on our burden the certified EHR technology adopted by capital costs will be higher. We invite estimates for each particular measure, as the EP, as all orders entered through comments on what the incremental well as what the incremental capital CPOE could be tracked. However, the costs of such additional functionality costs attributable to each measure might denominator for this measure could may be and what the reporting burden be. Estimates of total capital costs at the require EPs to manually track the using EHRs equipped with this bottom of Table 33 are derived from the number of orders entered through functionality might be. estimates used in the ‘‘Industry Costs’’ paper-based processes. Alternatively, Table 33 below lists those objectives section in Section V.G.4. EPs may choose to purchase EHRs and associated measures which we equipped with additional functionality estimate will require 0.5 hours to fulfill BILLING CODE 4120–01–P

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BILLING CODE 4120–01–C above in CY 2011 because such would be $22.8 billion ($23.9 billion ¥ First, we will discuss the burden information would help us determine $200 million ¥ $900 million). These associated with EP attestation to EHR more accurately the burden on the EPs. capital costs would decrease over the technology and Meaningful Use Set A Next, we discuss the burden for EPs course of the EHR incentive programs as objectives/measures, and ambulatory to gather information and attest to additional incentives are provided. quality measures. We estimate that it Meaningful Use Set B objectives/ Therefore, in 2012, the total net capital will take no more than 0.5 hour for an measures. We estimate that it takes costs for EPs would be $20.6 billion EP to attest that during the EHR about 8 hours for each EP to comply (22.8 billion ¥ $1.6 billion of Medicare reporting period, he or she used with this requirement. As stated, we incentives ¥ $650 million of Medicaid certified EHR technology and specify estimate that there are about 442,600 incentives). Over the course of 2011 and the technology, and satisfied each of the non-hospital-based EPs in CY 2011. The 2012, the average net capital costs applicable Meaningful Use Set A total estimated annual attestation would be $21.7 billion. objectives/measures. We also estimate burden hours for all EPs for the We expect that there will be a steady Meaningful Use Set B objectives and that it will take an EP an additional 0.5 growth in EPs. We estimate that in 2012, measures included in Table 33 is hour to select and attest to the there are about 447,400 non-hospital- 3,540,800 (442,600 EPs × 8 hours). The ambulatory quality measures for CY based Medicare, and Medicaid EPs cost burden for an EP to attest to the 2011.The total burden hours for an EP (326,900 Medicare EPs, 81,700 dual above information is $634.64 (8 hours × to attest to the above is one hour. We Medicare/Medicaid EPs and 38,800 $79.33/hour (the mean hourly rate for estimate that there are about 442,600 Medicaid-eligible-only EPs) who are physicians based on the May 2008 non-hospital-based Medicare and qualified to receive EHR incentive Bureau of Labor Statistics is $79.33) and Medicaid EPs (323,500 Medicare EPs, payment. In § 495.8(a)(2), we propose 80,900 dual Medicare/Medicaid EPs and $280,891,664 for EPs as a whole that to demonstrate meaningful use for 38,200 Medicaid-eligible-only EPs) who (3,540,800 hours × $79.33/hour). We CY 2012 and subsequent years, a may attest to the above (after invite public comments on the (registered) EP is required to attest, registration) in CY 2011 to receive an estimated percentages and the numbers through a secure mechanism in a EHR incentive payment. We estimate of (registered) EPs that will attest to Set specified manner, to the following: (1) the burden for the 28,000 MA EPs in the B objectives and measures in CY 2011 During the EHR reporting period, the EP MAO burden estimate section. The total because such information would help us used certified EHR technology and estimated annual attestation burden determine more accurately the burden specify the technology used; and (2) hours for EHR technology, Meaningful on the EPs. during the EHR reporting period, the EP Use Set A objectives/measures, and To estimate capital costs, we assume satisfied each of the applicable ambulatory quality measures are a certified EHR will cost roughly 442,600 for all EPs (442,600 EPs × 1 $54,000 as explained in section V.G.4 of objectives and associated measures hour). The cost burden for an EP to this proposed rule. If 442,600 EPs adopt under § 495.6 except § 495.8(d)(3) ‘‘ attest to the above information is $79.33 these EHRs, total capital costs prior to Report ambulatory quality measures to (1 hour × $79.33 (mean hourly rate for incentives would be roughly $23.9 CMS or the States (in the case of physicians based on the May 2008 billion. We also estimate that in 2011, Medicaid EPs).’’ Bureau of Labor Statistics)). The total $200 million of Medicare incentive For burden estimate purposes, we estimated annual cost burden for all EPs payments (the midpoint of the low and believe the burden associated with to attest to EHR technology, Meaningful high estimates in Tables 36 and 37) and gathering the information necessary to Use Set A objectives/measures, and $900 million of Medicaid incentive provide the attestations for the measures ambulatory quality measures is payments (the midpoint of the low and in Table 33, as well as the burden $35,111,458 (442,600 EPs × $79.33). We high estimates in Tables 45 and 46) associated with providing the actual invite public comments on the would be provided to EPs to help offset attestation, will remain unchanged from estimated percentages and the numbers those costs. Therefore, we estimate that CY2011. As detailed in Table 33, some of (registered) EPs that will attest to the total net capital costs for EPs in 2011 measures (Set A) will require a total of

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0.5 hours to report while others (Set B) annual burden hours for all EPs to hospitals or CAHs may choose to will require 1 hour. report and submit the ambulatory purchase EHRs equipped with First, we will discuss the burden for quality measures are 223,700 (447,400 additional functionality to enable more an EP to attest that during the reporting EPs × 0.5 hour). We believe that an EP efficient reporting, in which case period, he or she used certified EHR may assign a medical secretary to reporting burden may be less than an technology, specify the EHR technology, submit the specific ambulatory clinical hour but the capital costs will be higher. and he or she satisfied each of the quality measures to CMS or the States. We invite comments on what the applicable Set A objectives measures in Therefore, the cost burden for an EP to incremental costs of such additional CY 2012. We estimate it will take no submit these clinical quality measures is functionality may be and what the more than 0.5 hour for an EP to attest $7.41 (0.5 hour × $14.81 (mean hourly reporting burden using EHRs equipped to the above requirements. For burden rate for medical secretaries based on the with this functionality might be. estimate purposes, we estimate that all May 2008 Bureau of Labor Statistics)). First, we will discuss the burden for 447,400 non-hospital-based Medicare, The total annual cost burden for all EPs eligible hospitals and CAHs to attest to and Medicaid EPs (326,900 Medicare to report the clinical quality measures is the technology used and the Meaningful EPs, 81,700 dual Medicare/Medicaid $3,312,997 (223,700 hours × $14.81 Use Set A objectives/measures and EPs and 38,800 Medicaid-eligible-only (mean hourly rate for medical hospital quality measures in FY 2011. EPs) may attest (after registration) in secretaries based on the May 2008 We estimate that in FY 2011, there are 2012 to receive an EHR incentive Bureau of Labor Statistics)). about 5,011 Medicare and Medicaid payment. We estimate the burden for Similar to the requirements for EPs, eligible hospitals and CAHs that may be the 28,000 MA EPs in the MAO burden we propose in § 495.10(b)(1) that to qualified to receive EHR incentive estimate section. We estimate it will demonstrate meaningful use for FY payment. We estimate that it will take take an EP 0.5 hour to attest. The total 2011, an eligible hospital or CAH must no more than 1 hour for an eligible estimated annual attestation burden attest, through a secure mechanism in a hospital or CAH to attest (0.5 hour to hours for all EPs are 223,700 (447,400 specified manner, to the following: (1) attest to the EHR technology used and EPs × 0.5 hour). The cost burden for an During the EHR reporting period, the Meaningful Use Set A objectives/ EP to attest to the above information is eligible hospital or CAH used certified measures, and 0.5 hour to attest to the $39.67 (0.5 hour × $79.33 (mean hourly EHR technology and specify the hospital quality measures—a total of 1 rate for physicians based on the May technology used; and (2) during the EHR hour.) We estimate that there are about 2008 Bureau of Labor Statistics)). The reporting period specified by the 5,011 Medicare and Medicaid hospitals total estimated annual cost burden for eligible hospital or CAH, the eligible (including 3,620 acute care hospitals, all EPs to attest is $17,746,121 (223,700 hospital or CAH satisfied each of the 1,302 critical access hospitals, 78 hours × $79.33). We invite public applicable objectives and associated Medicaid children’s hospitals, and 11 comments on the estimated percentages measures under § 495.6 (including Medicaid cancer hospitals). For burden and the numbers of registered EPs that quality measures). The eligible hospital estimate purposes, we estimate that will attest to EHR technology used and or CAH must specify the EHR reporting 5,011 Medicare and Medicaid hospitals Meaningful Use Set A objectives/ period and provide the result of each may attest (after registration) in FY 2011 measures in CY 2012 because such applicable measure for all patients to receive an EHR incentive payment. information would help us determine admitted to the eligible hospital during The total estimated annual attestation more accurately the burden on the EPs. the EHR reporting period for which a burden hours for all hospitals are 5,011 Next, we will discuss the estimated selected measure is applicable. (5,011 hospitals and CAHs × 1 hour). burden for EP attestation for Meaningful We estimate that the certified EHR We believe that an eligible hospital or Use Set B objectives/measures. We technology adopted by the eligible CAH may assign an attorney to attest on estimate it will take an EP 8 hours to hospital or CAH will capture many of their behalf. The cost burden for an gather information and attest to the the objectives and associated measures. eligible hospital or CAH to attest to the Meaningful Use Set B objectives/ We estimate that it would take no more above information is $59.98 (1 hour × measures. We estimated annual than 0.5 hour for an eligible hospital or $59.98 (mean hourly rate for attorneys attestation burden hours in CY 2012 for CAH to attest that during the EHR based on the May 2008 Bureau of Labor all EPs for the Set B objectives and reporting period, they used EHR Statistics)). The total estimated annual measures included in Table 33 is technology, specify the technology used, cost burden for all eligible hospitals and 3,579,200 (447,400 EPs × 8 hours). and satisfied each of the applicable CAHs to attest is $300,560 (5,011 × Therefore, the cost burden for an EP to Meaningful Use objectives and $59.98). We invite public comments on attest to the above information is associated measures listed in Table 33– the estimated percentages and the $634.64 per EP (8 hours × $79.33/hour Set A. Because generating this numbers of (registered) eligible (mean hourly rate for physicians based automated information requires the hospitals and CAHs that will attest in on the May 2008 Bureau of Labor purchase of a certified EHR with the FY 2011 because such information Statistics) and $283,937,936 for EPs as requisite technical functionality, would help us determine more a whole (3,579,200 hours × $79.33/hour reporting these measures will incur accurately the burden on the hospitals (mean hourly rate for physicians based significant capital costs. and CAHs. We also invite comments on on the May 2008 Bureau of Labor Where reporting may require eligible the type of personnel or staff that would Statistics). hospitals or CAHs to manually gather most likely attest on behalf of eligible For ‘‘Report ambulatory quality the information necessary to report hospitals and CAHs. measures to CMS or the States’’ as stated numerators and denominators or to take Next, we will discuss the burden for in § 495.8(a)(2), we propose that in CY any other additional steps before eligible hospitals and CAHs to gather 2012, EPs must report, clinical quality attesting that the objective has been met, information and attest to Meaningful information in the form and manner we have estimated that it would take 1 Use Set B objectives/measures for FY specified by CMS, electronically to hour for an eligible hospital or CAH to 2011. We estimate that it may take an CMS. We estimate that the reporting/ gather that information and report the eligible hospital and CAH 7 hours to submission of these data to CMS should result. These measures are listed in comply with this requirement. As not take more than 0.5 hour. The total Table 33–Set B. Alternatively, eligible stated, we estimate there are about 5,011

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eligible hospitals and CAHs that may § 495.6(e)(2). The eligible hospital or and Medicaid hospitals and CAHs that attest to Meaningful Use Set B CAH must specify the EHR reporting may attest to the above requirements in objectives/measures. Therefore, the total period and provide the result of each FY 2012. Therefore, the total estimated estimated annual attestation burden applicable measure for all patients annual attestation burden hours for all hours for all eligible hospitals and CAHs admitted to the eligible hospital during eligible hospitals and CAHs for the Set for the Set B objectives and measures the EHR reporting period for which a B objectives and measures included in included in Table 33 is 35,077 (5,011 selected measure is applicable. We Table 33 are 35,077 (5,011 hospitals and hospitals and CAHs × 7 hours). We estimate that the certified EHR CAHs × 7 hours). We estimate that the estimate that the hospital or CAH may technology adopted by the eligible hospital or CAH may use an attorney to use an attorney to attest on their behalf. hospital or CAH will capture many of attest on behalf of its organization. Therefore, the cost burden for an the objectives and associated measures. Therefore, the cost burden for an eligible hospital or CAH to attest to Therefore, we estimate that it would eligible hospital or CAH to attest to the Meaningful Use Set B objectives/ take no more than 0.5 hour for an above information is $419.86 (7 hours × measures is $419.86 (7 hours × $59.98/ eligible hospital or CAH to attest to the $59.98/hour (mean hourly rate for hour (mean hourly rate for attorneys EHR technology used and objectives and attorneys based on the May 2008 Bureau based on the May 2008 Bureau of Labor associated measures listed in Table 33– of Labor Statistics)) and $2,103,918 for Statistics) and $2,103,918 for eligible Set A. Because generating this eligible hospitals and CAHs as a whole hospitals and CAHs as a whole (35,077 automated information requires the (35,077 hours × $59.98/hour (mean hours × $59.98/hour (mean hourly rate purchase of a certified EHR with the hourly rate for attorneys based on the for attorneys based on the May 2008 requisite technical functionality, May 2008 Bureau of Labor Statistics)), Bureau of Labor Statistics)), not reporting these measures will incur not including capital costs. including capital costs. significant capital costs. We do not We estimate the capital cost for 2012 To estimate capital costs, consistent anticipate there is a significant growth is $20.6 billion which is the same as with the sources cited in V.G.4, we in the number of hospitals or CAHs. We 2011, which was discussed earlier. assume that achieving meaningful use estimate that in FY 2012, the total Under § 495.8, for ‘‘Report hospital will require roughly a $5 million capital burden attestation burden hours for quality measures to CMS or the States’’, investment for the average hospital. If hospitals and CAHs are 2,506 (5,011 we propose that in FY 2012, eligible 5,011 hospitals adopt these EHRs, total hospitals and CAHs × 0.5 hour). We hospitals must report clinical quality capital costs prior to incentives would estimate that an eligible hospital or CAH measures through electronic submission be roughly $25.1 billion. We also may assign an attorney to attest on their from certified EHR technology. The estimate that in 2011, $2.1 billion of behalf. The attestation burden for an reporting of these data to CMS or States Medicare incentive payments (the mid- eligible hospital or CAH is $29.99 (0.5 should not take more than 0.5 hour. The point of the low and high estimates in hour × $59.98 (mean hourly rate for total annual reporting burden hours for Tables 39 and 40) and $900 million of attorneys based on the May 2008 Bureau eligible hospitals and CAHs is 2,506 Medicaid incentive payments (the mid- of Labor Statistics). The total cost (5,011 hospitals and CAHs × 0.5 hour). point of the low and high estimates in burden for all hospitals and CAHs to We believe that an eligible hospital or Tables 45 and 46) would be provided to attest to EHR technology used, and CAH may assign a medical secretary to eligible hospitals and CAHs to help Meaningful Use Set A objectives/ report/submit the hospital quality offset those costs. Therefore, we measures is $150,310 (2,506 hours × measures to CMS or the States. The estimate that total net capital costs for $59.98). We also invite comments on the reporting cost burden for an eligible hospitals in 2011 would be $22.1 billion type of personnel or staff that would hospital or CAH is $7.41 (0.5 hour × ($25.1 billion¥$2.1 billion¥$900 mostly likely attest on the behalf of $14.81 (mean hourly rate for medical million). These capital costs would eligible hospitals and CAHs. secretaries based on the May 2008 decrease over the course of the EHR Where reporting may require eligible Bureau of Labor Statistics)). The total incentive programs as additional hospitals or CAHs to manually gather annual reporting cost burden for all incentives are provided. Therefore, in the information necessary to report eligible hospitals and CAHs is $37,113 2012, the total net capital costs for numerators and denominators or to take (2,506 hours × $14.81 (mean hourly rate hospitals would be $19 billion (22.1 any other additional steps before for medical secretaries based on the May billion¥$2.2 billion of Medicare attesting that the objective has been met, 2008 Bureau of Labor Statistics)). ¥ incentives $900 million of Medicaid we have estimated that it would take 1 B. ICRs Regarding Participation incentives). Over the course of 2011 and hour for the eligible hospitals or CAHs Requirements for EPs, Eligible 2012, the average net capital costs to gather that information and report the Hospitals, and CAHs (§ 495.10) would be $20.6 billion. result for each of these measures or a Similar to the requirements for EPs, total of 7 hours to comply with this Since the EHR incentive payment we propose in § 495.8(b)(2) that to requirement in FY 2012. These program is new, we do not have enough demonstrate meaningful use in FY 2012 measures are listed in Table 33–Set B. information to estimate the information and subsequent years, an eligible Alternatively, eligible hospitals or CAHs collection requirements burden beyond hospital or CAH must attest, through a may choose to purchase EHRs equipped the first payment year for an EP, eligible secure mechanism in a specified with additional functionality to enable hospital, or CAH for this provision. manner, to the following: (1) During the more efficient reporting, in which case Furthermore, the EPs, eligible hospitals, EHR reporting period, the eligible reporting burden may be less than an and CAHs can enroll any time during hospital or qualifying CAH used hour but the capital costs will be higher. the first 5 years; therefore, it is difficult certified EHR technology and specify We invite comments on what the to predict with certainty the burden the technology used; and (2) during the incremental costs of such additional beyond the first payment year as the EHR reporting period specified by the functionality may be and what the burden depends on the number of eligible hospital or CAH, the eligible reporting burden using EHRs equipped participants. Therefore, we provide a hospital or CAH satisfied each of the with this functionality might be. best estimate of what we believe the applicable objectives and associated For burden estimate purposes, we burden associated with this provision measures under § 495.6. except estimate that there are 5,011 Medicare might be.

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Under § 495.10 (a)(b)(c), we propose register himself or herself or assign a doing two burden estimates for an EP that in order for an EP, eligible hospital, medical secretary to do it on his or her and his/her medical secretary. The cost or CAH to participate in the Medicare or behalf. Therefore, we are doing one high burden for an EP who chooses to update Medicaid EHR incentive program, they end burden estimate for an EP and one the registration information himself or must submit, in a manner specified by low end burden estimate for a medical herself is $39.67 (0.5 hour × $79.33 CMS, the following initial registration secretary. The cost burden for an EP (mean hourly rate for physicians based information in the first payment year: who chooses to register in the EHR on the May 2008 Bureau of Labor (1) Name of the EP, eligible hospital or incentive payment program himself or Statistics)). The total estimated annual CAH; (2) the National Provider herself is $39.67 (0.5 hour × $79.33 cost burden for all 49,214 EPs to update Identifier (NPI); (3) business address (mean hourly rate for physicians based registration information themselves is and business phone; (4) Taxpayer on the May 2008 Bureau of Labor $1,952,073 (49,214 EPs × 0.5 hour × Identification Number (TIN) to which Statistics)). The total estimated annual $79.33 (mean hourly rate for physicians the EP wants the incentive payment cost burden for all EPs who register for based on the May 2008 Bureau of Labor made; and (5) for an eligible hospital the EHR incentive payment program Statistics)). Similarly, the cost burden and CAH, their CMS Certification themselves is $17,555,729 (221,300 for the EP who chooses to use a medical Number (CCN) and its TIN. We estimate hours × $79.33 (mean hourly rate for secretary to update registration that the initial burden associated with physicians based on the May 2008 information on their behalf is $7.41 (0.5 the above requirements would be the Bureau of Labor Statistics)). Similarly, hour × $14.81 (mean hourly rate for time required to submit the required the cost burden for an EP who chooses medical secretaries based on the May registration information. to use medical secretary to register on 2008 Bureau of Labor Statistics)). The We estimate that in FY 2011, there are their behalf is $7.41 (0.5 hour × $14.81 total estimated annual cost burden for 5,011 Medicare and Medicaid eligible (mean hourly rate for medical 48,686 EPs who choose to use medical hospitals, and CAHs that may be secretaries based on the May 2008 secretaries to update registration qualified to receive EHR incentive Bureau of Labor Statistics)). The total information on their behalf is $364,429 payment. Since we cannot predict how estimated annual cost burden for all EPs (49,214 EPs × 0.5 hour × $14.81 (mean many eligible hospitals, and CAHs will who choose to use medical secretaries to hourly rate for medical secretaries based participate in the EHR incentive register on their behalf is $3,277,453 on the May 2008 Bureau of Labor payment program, we estimate that all (221,300 hours × $14.81 (mean hourly Statistics)). We only use the average of 5,011 hospitals may register for the rate for medical secretaries based on the the two estimates in the tally in Table incentive program for burden estimate May 2008 Bureau of Labor Statistics)). 34. We invite comments on whether we purposes. We estimate that it would We invite comments on whether we should use the higher cost burden take no more than 0.5 hour for an should use the higher cost burden estimate ($1,952,073) or the lower cost eligible hospital or CAH to register. We estimate ($17,555,729) or the lower cost burden estimate ($364,429). We also estimate the total annual burden hours burden estimate ($3,277,453). We only invite public comments on the for registration will be 2,506 (5,011 × use the average of the two estimates in estimated percentages and the numbers hospitals 0.5 hour). Once the decision the tally in Table 34. We invite public of EPs that will need to submit to participate in the incentive program comments on the estimated percentages subsequent registration changes to us is made, we believe eligible hospitals or or the numbers of EPs that will register over the course of the EHR incentive CAHs may assign a medical secretary to in 2011 and subsequent years and this payment program and such information submit the registration information. The information would help us determine would help us determine more cost burden for an eligible hospital or more accurately the burden on EPs accurately the burden on the EPs. CAH to register is $7.41 (0.5 hour × affected by this proposed rule. $14.81 (mean hourly rate for medical Similarly, for hospitals and CAHs, we secretaries based on the May 2008 In § 495.10(d), we propose that if propose that if there are subsequent Bureau of Labor Statistics)). We estimate there are subsequent changes in the changes in the initial registration that the total annual cost burden for initial registration information, the EP is information, the eligible hospital or eligible hospitals and CAHs to register responsible for providing us with CAH is responsible for providing us is $37,106 (5,011 hospitals × 0.5 hour × updated changes in the manner with updated information in the manner $14.81) (mean hourly rate for medical specified by us. Based on our specified by us. Based on our secretaries based on the May 2008 experience with provider enrollment, experience with provider enrollment, Bureau of Labor Statistics)). We invite we estimate that about 11 percent of the we estimate that about 8 percent of the public comments on the estimated Medicare and Medicaid EPs may need Medicare and Medicaid eligible percentages or the number of eligible to update their registration information hospitals and CAH (5,011 hospitals and hospitals and CAHs that will register for during a one-year period. We estimate CAHs × 8 percent = 401 hospitals) may the EHR incentive payment program in that EPs in this 11 percent (447,400 EPs need to update their registration 2011 and subsequent years. Such (estimated number of EPs in CY 2012) information during a one-year period. information would help us determine × 11 percent = 49,214 EPs) may only We estimate that eligible hospitals in more accurately the burden on the have one occasion that requires this 8 percent pool may only have 1 eligible hospitals and CAHs. updating of information in a given year. occasion that requires updating of We estimate that all 442,600 non- For each occasion, we estimate that it registration information in a given year. hospital-based Medicare, and Medicaid would take no more than 0.5 hour to For each occasion, we estimate that it EPs may register in 2011 to receive an notify us of the changes. With that, we would take no more than 0.5 hour to EHR incentive payment. We estimate estimate that the annual total burden notify us of the changes. With that, we that it would take no more than 0.5 hour hours for 49,214 EPs to update changes estimate that the total annual burden to complete the registration. The total are 24,607 (49,214 EPs × 0.5 hour). hours for eligible hospitals and CAHs to estimated annual registration burden However, we cannot predict if the EP update CMS of registration changes are hours for all EPs are 221,300 (442,600 will update the registration information 201 (401 hospitals and CAHs × 0.5 EPs × 0.5 hour) in the first payment himself or herself or assign a medical hour). We believe that eligible hospitals year. We cannot predict if an EP will secretary to do it. Therefore, we are or CAHs may assign a medical secretary

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to update the registration information. estimated annual cost burden for all use medical secretaries to notify CMS of We estimate the total annual cost dual Medicare/Medicaid EPs who use program changes is $604,989 (40,850 burden for eligible hospitals and CAHs medical secretaries to notify CMS of hours × $14.81 (mean hourly rate for to update CMS of registration changes is program selection is $599,065 (40,450 medical secretaries based on the May $2,969 (401 hospitals and CAHs × 0.5 hours × $14.81 (mean hourly rate for 2008 Bureau of Labor Statistics)). We hour × $14.81) (mean hourly rate for medical secretaries based on the May invite comments on whether we should medical secretaries based on the May 2008 Bureau of Labor Statistics)). We use the higher cost burden estimate 2008 Bureau of Labor Statistics)). We only use the average of the two ($3,240,630) or the lower cost burden invite public comments on the estimates in the tally in Table 34. We estimate ($604,989). We only use the estimated percentages and the numbers invite comments on whether we should average of the two estimates in the tally of eligible hospitals and CAHs that will use the higher cost burden estimate in Table 34. We also invite public submit subsequent registration changes ($3,208,899) or the lower cost burden comments on the estimated percentages to us over the course of the EHR estimate ($599,065). We also invite and the numbers of dual Medicare/ incentive payment program and this public comments on the estimated Medicaid EPs that will submit initial information would help us determine percentages and the number of dual Medicare or Medicaid program changes more accurately the burden on the Medicare/Medicaid EPs that will submit in 2012, 2013, or 2014 and this eligible hospitals and CAHs. initial Medicare or Medicaid program information would help us determine In § 495.10(e)(1), we propose that for selection in 2011, 2012, 2013, or 2014 more accurately the burden on the EPs participation in the EHR incentive and this information would help us affected by the proposed rule. payment programs, prior to the first determine more accurately the burden C. ICRs Regarding Identification of payment year, an EP must notify us in on the EPs affected by the proposed Qualifying MA Organizations, MA–EPs a specified manner as to whether he or rule. and MA-Affiliated Eligible Hospitals she elects to participate in the Medicare Under § 495.10(e)(2), we propose that (§ 495.202) or Medicaid EHR incentive program. We EPs may switch from Medicare to Proposed § 495.202(a)(1) states that estimate that in 2011, there are about Medicaid EHR incentive program or beginning with bids due in June 2010 80,900 dual Medicare/Medicaid EPs vice versa one time, and only for (for plan year 2011), MA organizations who may make the initial Medicare and payment year 2014 or before. Since we seeking reimbursement for qualifying Medicaid program selection. The have no knowledge of how many EPs MA EPs and qualifying MA-affiliated standard full amount of Medicaid will make the subsequent changes in eligible hospitals under the MA EHR incentive payments that an EP could program selection, we assume that all incentive program are required to receive is larger than the standard full 81,700 (estimated number of dual identify themselves to CMS in a form an amount for the Medicare EP incentive Medicare/Medicaid EPs for CY 2012) manner specified by CMS, as part of payments. Therefore, for burden dual Medicare/Medicaid EPs may make submissions of initial bids under section estimate purposes, we believe that all of subsequent program selection changes 1854(a)(1)(A) of the Act. The burden the 80,900 dual Medicare/Medicaid EPs for burden estimate purposes. We associated with this requirement is may make the Medicaid program estimate that it would take no more than providing a list of MA EPs and selection for burden estimate purposes. 0.5 hour to submit the Medicare/ qualifying MA-affiliated eligible We estimate that it would take no more Medicaid selection change to us. We hospitals who may potentially seek for than 0.5 hour to submit the initial cannot predict if the EP will submit the EHR incentive payments. However, for Medicare or Medicaid selection change to CMS himself or herself or EPs, we believe there is no extra burden notification to us. We cannot predict if assign a secretary to do it. Therefore, we incur from this requirements as MA the EP will submit the notification to are doing one high end burden estimate organizations can identify the same lists CMS himself or herself or assign a for an EP and one low end estimate for of names of EPs as they used to satisfy secretary to do it. Therefore, we are a medical secretary. The total estimated the collection requirements for doing one high end estimate and one burden hours for all dual Medicare/ § 495.204(b)(2) and (5). In other words, low end burden estimate for an EP and Medicaid EPs to notify CMS of program when identifying amounts of a medical secretary respectively. The changes are 40,850 (81,700 EPs × 0.5 compensation per § 495.204(b)(2) and total estimated burden hours for all the hour) in a given year. The cost burden (5), qualifying MA organizations will be dual Medicare/Medicaid EPs to notify for the EP who choose to notify CMS of simultaneously identifying EPs under CMS of program selection are 40,450 Medicare/Medicaid program change this requirement. For hospitals, we (80,900 EPs × 0.5 hour) in the first himself or herself is $39.67 (0.5 hour × estimate that it may take no more than payment year. The cost burden for these $79.33 (mean hourly rate for physicians 0.25 hour for a MA organization to EPs who notify CMS of Medicare or based on the May 2008 Bureau of Labor identify their MA-affiliated hospitals to Medicaid program selection himself or Statistics)). The total estimated annual CMS. There are 29 MA-affiliated eligible herself is $39.67 (0.5 hour × $79.33 cost burden for all dual Medicare/ hospitals and 12 MA organizations or an (mean hourly rate for physicians based Medicaid EPs to notify CMS of program average of 2.42 eligible hospitals for on the May 2008 Bureau of Labor changes themselves is $3,240,630 each MA organization. The total burden Statistics)). The total estimated annual (40,850 hours × $79.33 (mean hourly hours for all MA organizations to cost burden for all dual Medicare/ rate for physicians based on the May identify their affiliated hospitals to CMS Medicaid EPs to notify CMS of program 2008 Bureau of Labor Statistics)). are 3 hours. We believe a MA selection themselves is $3,208,899 Similarly, the cost burden for an EP who organization may use a billing clerk to (40,450 hours × $79.33). Similarly, the chooses to use a medical secretary to identify the eligible hospital to us. The cost burden for an EP who chooses to notify CMS of program changes is $7.41 cost burden for a MA organization is use medical secretaries to notify CMS of (0.5 hour × $14.81 (mean hourly rate for $3.86 (0.25 hour × $15.44 (mean hourly program selection is $7.41 (0.5 hour × medical secretaries based on the May rate for billing clerks based on the May $14.81 (mean hourly rate for medical 2008 Bureau of Labor Statistics)). The 2008 Bureau of Labor Statistics)). The secretaries based on the May 2008 total estimated annual cost burden for total cost burden for all MA Bureau of Labor Statistics)). The total all dual Medicare/Medicaid EPs who organizations to identify their eligible

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hospitals to us is $46.32 ($3.86 × 12 MA all MA organizations to attest are 6 clerk to report the required data to CMS. organizations). hours. We believe that MA We estimate the cost burden for a MA We proposed in § 495.202(a)(3) that organizations may use an attorney to organization to report is $617.6 (40 qualifying MA organizations offering attest on their behalf. The cost burden hours × $15.44 (mean hourly rate for MA plan types other than HMOs are for a MA organization to attest is $29.99 billing clerk based on the May 2008 required to attest to the fact that they (0.5 hour × $59.98 (mean hourly rate for Bureau of Labor Statistics)). We estimate meet the definition of HMO in 42 U.S.C. attorneys based on the May 2008 Bureau the total annual cost burden for all MA 300gg–91(b)(3)-section 2791(b)(3) of the of Labor Statistics)). The total cost organizations to comply with this PHS Act. There is minimal burden burden for all MA organizations to attest requirement is $7,411 (12 MA associated with this requirement as is $359.88 ($29.99 × 12 MA organizations × $617.6). qualifying MA organizations sponsoring organizations). We invite comments on Under § 495.204(b)(4), we propose MA coordinated care plans, like PPOs, the type of personnel who will mostly that for qualifying MA EPs who are PSOs, and RPPOs, are not expected to likely attest on behalf of MA compensated on a salaried basis, CMS employ physicians that meet the organizations. requires the qualifying MA organization definition of MA EP in section Proposed § 495.202(b)(4) states that all to develop a methodology for estimating 1853(1)(2) of the Act and therefore, we qualifying MA organizations, as part of the portion of each qualifying MA EP’s do not expect any to need to attest. their initial bids in June 2014 for plan salary attributable to providing services Similarly, we do not expect any MA year 2015, must identify potentially that would otherwise be covered under organizations that offer other plan types qualifying MA EPs and potentially Part B to MA plan enrollees of the MA other than coordinated care plans to qualifying MA-affiliated eligible organization. The methodology: (i) Must request need to attest to their status for hospitals. An attestation that each be approved by CMS; and (ii) may similar reasons. professional or hospital either meets or include an additional amount related to In § 495.202(a)(4), we propose does not meet the eligibility criteria overhead, where appropriate, estimated requiring that, beginning with bids due must be included as part of the to account for the MA-enrollee related in June 2014 (for plan year 2015), all identification submission. We cannot Part B practice costs of the salaried MA organizations with potentially estimate the collection burden for this qualifying MA EP. We estimate that it qualifying MA EPs or potentially requirement as the timeframe goes may take a MA organization one and a qualifying MA-affiliated eligible beyond the scope of the effective date of half hour to develop the methodology. hospitals under the MA EHR incentive the proposed information collection We estimate that there are about two program to identify themselves to CMS period (3 years from the effective date MA organizations that may have the in a form and manner specified by CMS, of the final rule). need to develop the methodology. The as part of submissions of initial bids total burden hours for the MA D. ICRs Regarding Incentive Payments under section 1854(a)(1)(A) of the Act. organizations to develop the to Qualifying MA Organizations for MA– We cannot estimate the collection methodology are 3 hours (1.5 hours × 2 EPs and Hospitals (§ 495.204) burden for this requirement as the MA organizations). A MA organization timeframe goes beyond the scope of the Under § 495.204(b)(2), we propose may use an accountant to develop the effective date of the proposed that a qualifying MAO would need to methodology. The cost burden for a MA information collection period (three report to CMS within 30 days of the organization is $47.48 (1.5 hours × years from the effective date of the final close of the calendar year, the aggregate $31.65 (mean hourly rate for rule). annual amount of revenue attributable accountants based on the May 2008 In § 495.202(b)(1), we propose that a to providing services that would Bureau of Labor Statistics)). The total qualifying MA organization, as part of otherwise be covered as professional cost burden for the MA organizations to its initial bid starting with plan year services under Part B received by each develop the methodology is $94.95 2011, must make preliminary qualifying MA EP for enrollees in MA ($47.48 × 2 MA organizations). identification of potentially qualifying plans of the MA organization in the In § 495.204(b)(5), we propose that for MA EPs and potentially qualifying MA- payment year. Since the tracking of qualifying MA EPs who are not salaried, affiliated eligible hospitals for which the salaries or compensation for MA EPs qualifying MA organizations would organization is seeking incentive constitutes usual and customary need to obtain, and submit to CMS, payments. The burden for this business practices, the only burden attestations from such qualifying MA requirement is already addressed in associated with this requirement is the EPs as to the amount of compensation § 495.202 (a)(1) and § 495.204(b)(2)(5). time required to submit the aggregated received by such EPs for MA plan In § 495.202(b)(2), we propose that MA- annual amount of revenue received by enrollees of the MA organization. We affiliated organizations must provide each qualifying MA EP for enrollees in estimate that about 10 percent of the and attest to the following information MA plans of the MA organization. We MA EPs (28,000 EPs × 10 percent = on their MA-affiliated EPs and eligible estimate that there are 12 MA 2,800 EPs) are not salaried and that is hospitals: (A) Name of the EP or eligible organizations and 28,000 MA EPs, or an an average of 233 (2,800 EPs/12 MA hospital; (B) address of the EP or eligible average of 2,333 (28,000 EPs/12 MA organizations = 233 EPs) non-salaried hospital; and (C) NPI. We believe that it organizations) MA EPs affiliated with EPs in each MA organization. We is customary and business practices of each qualifying MA organization. We estimate that it may take up to 0.25 hour an MA organization to keep the believe that it will take a MA to electronically obtain and compile information in (A), (B), and (C) on file. organization 40 hours annually to report each attestation into a document for The burden for this requirement is the the required aggregate revenue data for transmission to CMS. The total burden time it takes to attest to CMS that the all its salaried MA EPs, given that all the hours for a MA organization are 58.3 MA EPs or MA-affiliated eligible data are readily available. The total (0.25 hour × 233 EPs). The total hospitals meet the eligibility criteria. estimated annual burden hours for all estimated burden hours for all MA We estimate it should not take more MA organizations to comply with this organizations are 699 (58.3 × 12 MA than 0.5 hour for a MA organization to requirement is 480 (12 MA organizations). We believe an MA comply with this attestation organizations × 40 hours). We believe organization may involve a billing clerk requirement. The total burden hours for MA organizations may involve a billing to compile and submit the

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compensation information from such and MA-affiliated hospitals are treated § 495.306(a)(1)(i) and § 495.306(a)(1)(ii). attestations. We estimate the cost the same as all Medicare-certified MA The total labor cost associated with the burden for a MA organizations to affiliated hospitals and they will attest requirement in § 495.306(a)(1)(i) is comply with this requirement is like other Medicare FFS hospitals. This $4,720,135. The total labor cost approximately $899.38 (0.25 hour × 233 means that § 495.210(c) only applies to associated with the requirement in EPs × $15.44 (mean hourly rate for a MA-affiliated hospital that is not § 495.306(a)(1)(ii) is $4,720,135. We billing clerk based on the May 2008 Medicare certified and such type of reached these costs estimates since it Bureau of Labor Statistics)). We estimate hospitals do not exist currently. We do will be important for physicians (rather the total annual cost burden for all MA not expect there to be any MA-affiliated than staff assistants) to establish patient organizations to comply with this hospitals that will not be covered under volume at $79.33 (mean hourly rate for requirement is $10,792.56 (58.3 hours × the Medicare FFS EHR hospital physicians based on the May 2008 12 organizations × $15.44). incentive program because section Bureau of Labor Statistics)). 1852(a)(1)(A) of the Act requires MA The burden associated with the E. ICRs Regarding Meaningful User organizations to provide Part A requirements in proposed Attestation (§ 495.210) inpatient services solely through § 495.306(a)(1)(ii)(B) and § 495.306(a)(2) Under § 495.210(b), we propose providers that meet applicable is the time and effort necessary to requiring qualifying MA organizations requirements of the Medicare program. submit the information to CMS. In each to attest within 30 days after the close We have already addressed the instance, we estimate that it will take no of a calendar year whether each attestation burden on hospitals, longer than 0.5 hour to submit the qualifying MA EP is a meaningful EHR including MA-affiliated hospitals under necessary information to CMS. For user. We anticipate that the adopted § 495.10(b)(2)(i)(ii). proposed § 495.306(a)(1)(ii)(B) and EHR technology will capture the data § 495.306(a)(2), we estimate that 3,361 for determination whether each F. ICRs Regarding Establishing Patient entities will submit the required qualifying MA EP is a meaningful EHR Volume (§ 495.306) information. Similarly, we estimate the user. The burden associated with this Proposed § 495.306(a) states that to total annual burden to be 1,815.50 hours requirement is the time necessary to establish patient volume, a Medicaid in both § 495.306(a)(1)(ii)(B) and attest to the required information. We provider must annually meet one of the § 495.306(a)(2). The total labor cost estimate that there are 12 MA requirements contained in associated with the requirement in organizations and 28,000 MA EPs, or an § 495.306(a)(1). Proposed § 495.306(a)(1)(ii)(B) is $144,024. This average of 2,333 MA EPs affiliated with § 495.306(a)(1)(i) states that except as cost burden is based on the physician each qualifying MA organization. We specified in paragraph (a)(1)(ii) of this establishing patient volume at $79.33 believe that it will take a MA section, a Medicaid professional must (mean hourly rate for physicians based organization about 40 hours annually to attest that a minimum of 30 percent of on the May 2008 Bureau of Labor attest whether each qualifying MA EP is their patient encounters over any Statistics)). The total labor cost a meaningful user, given that all the continuous 90-day period in the most associated with the requirement in data are captured in the certified EHR recent calendar year was covered by § 495.306(a)(2) is $25,617. This cost technology. The total estimated annual Medicaid. Proposed burden is based on a secretary reporting burden hours for all MA organizations § 495.306(a)(1)(ii)(A) states that a patient volume on behalf of the acute to comply with this requirement is 480 pediatrician must attest that a minimum care hospital at $14.11 (mean hourly (12 MA organizations × 40 hours). We of 20 percent of his or her patient rate for secretaries based on the May believe MA organizations may involve encounters over any continuous 90-day 2008 Bureau of Labor Statistics)). an attorney to attest on their behalf. We period in the most recent calendar year estimate the cost burden for a MA was covered by Medicaid. Proposed G. ICRs Regarding Process for Payments organization to attest is $2,399 (40 hours § 495.306(a)(1)(ii)(B) states that a (§ 495.312) × $59.98 (mean hourly rate for attorneys Medicaid professional practicing Proposed § 495.312(b) states that in based on the May 2008 Bureau of Labor predominantly in a FQHC or RHC must order to receive a payment under this Statistics)). We estimate the total annual attest that a minimum of 30 percent of part, a provider must report the required cost burden for all MA organizations to his or her patient encounters over any data under this subpart within the EHR comply with attestation for MA EPs is continuous 90-day period in the most reporting period described in § 495.6. $28,790 (12 MA organizations × $2,399). recent calendar year was with needy The data required is the information We invite comments on the type of individuals as defined in § 495.302. necessary to document that the provider personnel, who will mostly attest on Proposed § 495.306(a)(2) states that an is a meaningful user or an adopter, behalf of MA organizations. acute care hospital must attest that a implementer, or upgrader of certified Section 495.204(c)(2) states that to the minimum of 10 percent of all patient EHR technology and the data reported to extent data are available, qualifying MA encounters over any continuous 90-day the single provider election repository. organizations must receive hospital period in the most recent calendar year The burden associated with this incentive payments through their was covered by Medicaid. requirement is the time and effort affiliated hospitals under the Medicare The burden associated with the necessary to report the required data to FFS EHR hospital incentive program, requirements in this section is the time States during the EHR reporting period. rather than through the MA EHR and effort necessary to submit the This burden is accounted for in our hospital incentive program. Under information to CMS. In each instance, burden discussions for sections A and B § 495.210(c), we proposed that we estimate that it will take no longer of the information collection section, qualifying MA organizations be required than 0.5 hour to submit the necessary § 495.10 and § 495.12, respectively. to attest within 30 days after the close information to CMS. For proposed of a calendar year whether each § 495.306(a)(1)(i) through (ii), we H. ICRs Regarding Activities Required qualifying MA-affiliated eligible estimate that 119,000 entities will To Receive an Incentive Payment hospital is a meaningful EHR user. As submit the required information. (§ 495.314) stated in the preamble, the EHR Similarly, we estimate the total annual Proposed § 495.314(a)(1) states that in incentive payments for Medicare FFS burden to be 59,500 hours in both the first payment year, to receive an

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incentive payment, the Medicaid EP or receive an incentive payment for each FFP under this subpart if the total State eligible hospital must meet one of the payment year, as described in § 495.314. and Federal acquisition cost is more following criteria. The Medicaid EP or Burden is calculated for each State’s than $100,000. Burden must be eligible hospital must demonstrate that process for the administration of the calculated for State Medicaid Agencies during the EHR reporting period for a Medicaid incentive payments, including to submit the planning and payment year, it has adopted, tracking of attestations and oversight, implementation documents and the implemented, or upgraded certified EHR and the process for approving, SMHP to CMS including, among other technology, as defined in § 495.302; or, processing, and making timely things, an alternative approach to the the Medicaid EP or eligible hospital payments. established timeframe for measuring must demonstrate that during the EHR We estimate that there will be patient volume, the process for verifying reporting period for a payment year it is approximately 50 States, the District of eligibility, annual reports specifying a meaningful user of certified EHR Columbia, and 5 Territories per year provider adoption, implementation, technology as defined in § 495.6. requesting reimbursement for the and/or upgrading of certified EHR The burden associated with the administration of and paying of technology activities and payments, requirements in proposed Medicaid incentive payments to proposed additional quality measures, § 495.314(a)(1) is the time and effort providers for the meaningful use of and the data supporting the adoption, necessary for a Medicaid EP or eligible electronic health record systems. For implementation, or upgrading and hospital to demonstrate that it meets States to collect and submit the meaningful use of certified EHR one of the criteria in § 495.314(a)(1)(i) information required, we estimate it will technology. This burden is the same as through (ii). We already accounted for take 5 hours per State. The estimated that listed above in the burden this burden in the earlier discussion of annual burden for States associated with discussion for § 495.316. the burden associated with § 495.10. the aforementioned submission Proposed § 495.314(a)(2) states that a requirements is 280 hours (56 States- L. ICRs Regarding Termination of provider may notify the State of its Territories × 5.0 hours/State-Territory). Federal Financial Participation (FFP) for nonbinding intention to participate in The cost burden was estimated based on Failure To Provide Access to the incentives program prior to having an employee contracting with the State Information (§ 495.330) fulfilled all of the eligibility criteria. Agency. The burden associated with Proposed § 495.330(a) states that the This requirement constitutes a third- § 495.316 is already in the OMB Department terminates FFP at any time party disclosure. The burden associated approval process. We announced the if the Medicaid agency fails to provide with this requirement is the time and information collection in a Federal State and Federal representatives with effort necessary for a provider to send Register notice that published on full access to records relating to HIT notification to the State. We estimate September 11, 2009 (74 FR 467330). planning and implementation efforts, that this burden will be the same burden and the systems used to interoperate associated with § 495.12 as stated above, J. ICRs Regarding State Responsibilities with electronic HIT, including on-site since the information necessary to for Receiving FFP (§ 495.318) inspection. Proposed § 495.330(b) states notify the State of the providers non- Proposed § 495.318 states that in that the Department may request such binding intention to participate in the order to be provided FFP under section access at any time to determine whether program could be the same information 1903(a)(3)(F) of the Act, a State must the conditions in this subpart are being as submitted by those providers that demonstrate to the satisfaction of the met. The burden associated with the have committed to participating in the Department, that the State is conducting requirements in this section is the time program, that is, the National Provider the activities listed at § 495.318(a) and effort necessary to make the Identifier, the tax identification number, through (c). This burden is the same as information available to the Department etc. that listed above in the burden upon request so it can monitor Proposed § 495.314(b)(1) states that in discussion for § 495.316. compliance. The Department estimates the second, third, fourth, fifth, and sixth that it will make 1 request per State/ payment years, to receive an incentive K. ICRs Regarding Prior Approval Territory per year for information and payment, the Medicaid EP or eligible Conditions (§ 495.324) that it will take each State 5 hours to hospital must demonstrate that during Proposed § 495.324(a) would require a compile and furnish the information. the EHR reporting period for the State to obtain prior written approval We estimate that there will be applicable payment year, it is a from the Department as specified in approximately 50 States, the District of meaningful user of certified EHR paragraph (b) of this section, when the Columbia, and 5 Territories per year technology, as defined in § 495.6. The State plans to initiate planning and submitting this information. For States burden associated with this requirement implementation activities in support of to collect and submit the information is the time and effort necessary for a Medicaid provider incentive payments required, we estimate it will take 5 Medicaid EP or eligible hospital to encouraging the adoption and use of hours per State. The estimated annual demonstrate that it is a meaningful user certified EHR technology with proposed burden for States associated with the of certified EHR technology. We Federal financial participation (FFP). aforementioned submission discussed the burden associated with Specifically, proposed § 495.324(b) requirements is 280 hours (56 States- this requirement in our discussion of states that to receive 90 percent match, Territories × 5.0 hours/State-Territory). the burden associated with § 495.10. each State must receive prior approval The annual cost burden for a State for all of the requirements listed in employee to provide the above I. ICRs Regarding State Monitoring and § 495.324(b)(1) through (3). information is $9,904 (280 hours × Reporting Regarding Activities Required Proposed § 495.324(c) would require a $35.37 (mean hourly rate for a To Receive an Incentive Payment State to obtain prior written approval management analyst based on the May (§ 495.316) from the Department of its justification 2008 Bureau of Labor Statistics)). We Proposed § 495.316(a) would require for a sole source acquisition, when it believe that it is possible that a secretary States to be responsible for tracking and plans to acquire non-competitively from may compile State information and verifying the activities necessary for a a nongovernmental source HIT provide the information to the Medicaid EP or eligible hospital to equipment or services, with proposed Department. In that case the annual cost

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burden for the secretary to provide this needed to comply are usual and contract administration is $9,904 (280 information is $3,951 (280 hours × customary. hours × $35.37 (mean hourly rate for a $14.11 (mean hourly rate for secretaries However, there is burden associated management analyst based on the May based on the May 2008 Bureau of Labor with making the information available 2008 Bureau of Labor Statistics)). Statistics)). to the Department upon request. This burden is described in the burden P. ICRs Regarding State Medicaid M. ICRs Regarding State Medicaid discussion for § 495.330. Agency Attestations (§ 495.350) Agency and Medicaid EP and Hospital Proposed § 495.350 would require Activities (§ 495.332 Through § 495.344) O. ICRs Regarding Procurement States to provide assurances to the Standards (§ 495.348) The burden associated with this Department that amounts received with section is the time and effort associated Proposed § 495.348(c) states that a respect to sums expended that are with completing the single provider grantee must maintain written standards attributable to payments to a Medicaid election repository and each State’s of conduct governing the performance of provider for the adoption of EHR are process for the administration of the its employees engaged in the award and paid directly to such provider, or to an Medicaid incentive payments, including administration of contracts. The burden employer or facility to which such tracking of attestations and oversight; associated with this requirement is the provider has assigned payments, the submission of the State Medicaid time and effort necessary for a grantee without any deduction or rebate. The to develop and maintain written HIT Plan and the additional planning burden associated with this requirement standards of conduct. We estimate that and implementation documents; is the time and effort necessary for a it will take each of the 56 grantees 0.5 enrollment or reenrollment of providers, State to verify that the sums expended hour to develop and maintain standards and collection and submission of the are attributable to payments to a of conduct. The total estimated annual data for adopting, implementing, or Medicaid provider for the adoption of burden is 28 hours (56 grantees × 0.5 upgrading and meaningful use of EHR are paid directly to such provider, hours). The annual cost burden for a certified EHR technology. This burden or to an employer or facility to which grantee to develop and maintain such provider has assigned payments, is the same as that listed above in the standards of conduct is $990 (28 hours without any deduction or rebate. burden discussion for § 495.316. × $35.37 (mean hourly rate for a Additionally, there is burden associated N. ICRs Regarding Access to Systems management analyst based on the May with submitting an attestation to the and Records (§ 495.346) 2008 Bureau of Labor Statistics)). Department to that effect. The estimated Proposed § 495.348(e) would require burden associated with these Proposed § 495.346 states that the that all grantees establish written requirements is 0.5 hour to verify the State agency must allow the Department procurement procedures. At a information and 0.5 hour to submit the access to all records and systems minimum, the standards must provide attestation to the Department, for a total operated by the State in support of this for the information listed in of 1 hour. We estimate that there will be program, including cost records § 495.348(e)(1) through (13). The burden approximately 50 States, the District of associated with approved administrative associated with this requirement is the Columbia and 5 Territories per year funding and incentive payments to time and effort necessary for a grantee verifying this information and Medicaid providers. State records to develop and maintain written submitting attestations to the related to contractors employed for the procurement procedures. We estimate Department. The estimated annual purpose of assisting with that it will take each of the 56 grantees burden for States associated with the implementation or oversight activities 0.5 hour to develop and maintain aforementioned submission or providing assistance, at such written procurement procedures. The requirements is 56 hours (56 States- intervals as are deemed necessary by the total estimated annual burden is 28 Territories × 1 hours State-Territory). Department to determine whether the hours (56 grantees × 0.5 hours). The The annual cost burden for a State conditions for approval are being met annual cost burden for a grantee to employee to provide the above and to determine the efficiency, develop and maintain written information is $1,981 (56 hours × $35.37 economy, and effectiveness of the procurement procedures is $990 (28 (mean hourly rate for a management program. hours × $35.37 (mean hourly rate for a analyst based on the May 2008 Bureau This section imposes both management analyst based on the May of Labor Statistics)). We believe that it recordkeeping and reporting 2008 Bureau of Labor Statistics)). is possible that a secretary may compile requirements. The burden associated Proposed § 495.348(f) imposes a State information and provide the with this requirement is the time and recordkeeping requirements. This information to the Department. In that effort necessary for a State to both section states that a system for contract case the annual cost burden for the maintain records and to make them administration must be maintained to secretary to provide this information is available to the Department upon ensure contractor performance with the $790 (56 hours × $14.11 (mean hourly request. The Department believes that terms, conditions and specifications of rate for secretaries based on the May the burden associated with maintaining the contract and to ensure adequate and 2008 Bureau of Labor Statistics)). the records is exempt under 5 CFR timely follow up on all purchases. The 1320.3(b)(2) as this burden is part of a burden associated with this requirement Q. ICRs Regarding Reporting usual and customary business practice; is the time and effort necessary to Requirements (§ 495.352) the time, effort, and financial resources develop and maintain a system for Proposed § 495.352 would require necessary to comply with a collection of contract administration. We estimate each State to submit to the Department information that would be incurred by that it will take each of the 56 grantees on a quarterly basis a progress report persons in the normal course of their 5 hours to develop and maintain a documenting specific implementation activities (for example, in compiling and system for contract administration. The and oversight activities performed maintaining business records) will be total estimated annual burden is 280 during the quarter, including progress in excluded from the ‘‘burden’’ if the hours (56 grantees × 5 hours). The implementing the State’s approved agency demonstrates that the reporting, annual cost burden for a grantee to Medicaid HIT plan. The burden recordkeeping, or disclosure activities develop and maintain a system for associated with this requirement is the

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time and effort necessary for a State to incentive payments. We estimate that it Proposed § 495.366(d)(2) specifies that draft and submit quarterly progress will take each of the 50 States, the subject to § 495.332, the State must have reports to the Department. We estimate District of Columbia and 5 Territories, 5 a process in place to assure that that there will be approximately 50 hours to compile and report this expenditures for administering the States, the District of Columbia, and 5 information. The estimated annual Medicaid EHR incentive payment Territories per year drafting and burden for States associated with the program will not be claimed at amounts submitting the quarterly progress aforementioned requirements is 280 higher than 90 percent of the cost of reports. For States to collect and submit hours (56 States-Territories × 5 hours such administration. Proposed the information required, we estimate it State-Territory). § 495.366(d)(3) states that subject to will take 5 hours per State. The The annual cost burden for a State § 495.332, the State must have a process estimated annual burden for States employee to provide the above in place to assure that expenditures for × associated with the aforementioned information is $9,904 (280 hours payment of Medicaid EHR incentive submission requirements is 280 hours $35.37 (mean hourly rate for a payments will not be claimed at × (56 States-Territories 5 hours/State- management analyst based on the May amounts higher than 100 percent of the Territory). 2008 Bureau of Labor Statistics)). We cost of such payments to Medicaid The annual cost burden for a State believe that it is possible that a secretary providers. This burden is the same as employee to provide the above may compile State information and × that listed above in the discussion of information is $9,904 (280 hours provide the information to the § 495.316. $35.37 (mean hourly rate for a Department. In that case the annual cost management analyst based on the May burden for the secretary to provide this Proposed § 495.366(e) discusses the 2008 Bureau of Labor Statistics)). We information is $3,951 (280 hours × information collection requirements believe that it is possible that a secretary $14.11 (mean hourly rate for secretaries associated with improper Medicaid may compile State information and based on the May 2008 Bureau of Labor electronic health record payment provide the information to the Statistics)). incentives. The burden associated with Department. In that case the annual cost Proposed § 495.366(a)(2) would the requirements listed in proposed burden for the secretary to provide this require a State to have an automated § 495.366(e)(1) through (7) is the time information is $3,951 (280 hours × payment and information retrieval and effort necessary to develop $14.11 (mean hourly rate for secretaries mechanized system (Medicaid processes to provide the necessary based on the May 2008 Bureau of Labor Management Information System), to assurances discussed in this section. Statistics)). make EHR payment incentives, to This burden is the same as that listed ensure Medicaid provider eligibility, to above in the discussion of § 495.316. R. ICRs Regarding Retroactive Approval ensure the accuracy of payment of FFP With an Effective Date of incentives, and to identify potential T. ICRs Regarding Appeals Process for February 18, 2009 (§ 495.362) improper payments. Since States a Medicaid Provider Receiving Proposed § 495.362 states that for already have an automated payment and Electronic Health Record Incentive administrative activities performed by a information retrieval system, there is no Payments (§ 495.370) State, without obtaining prior approval, need to estimate this burden. Proposed § 495.370(a) would require which are in support of planning for Proposed § 495.366(b) lists the states to have a process in place incentive payments to providers, a State information collection requirements consistent with the requirements may request consideration of FFP by associated with provider eligibility as a established in § 447.253(e) of this recorded request in a HIT basis for making payment. States must, chapter for a provider or entity to appeal implementation planning advance subject to § 495.332, collect and verify incentive payments, incentive payment planning document or implementation information on Medicaid providers. amounts, provider eligibility advance planning document update. This burden is the same as that listed determinations, and the demonstration While this requirement is subject to the above in the discussion of § 495.316. of adopting, implementing, or upgrading Proposed § 495.366(c) discusses PRA, we believe the burden is already and meaningful use of certified EHR information collection requirements covered in the discussion of proposed technology. This burden is the same as pertaining to meaningful use and efforts § 495.332 through § 495.344. that listed above in the discussion of to adopt, implement, or upgrade to § 495.316. S. ICRs Regarding Financial Oversight certified electronic health record and Monitoring Expenditures technology to make payment. These numbers are subject to a (§ 495.366) Specifically, proposed § 495.366(c)(1) substantial amount of uncertainty and Proposed § 495.366(a)(2) would states that subject to § 495.332, the State actual experience may be significantly require a State to have a process in place must annually collect and verify different. The range of possible to report actual expenditures for the information regarding the efforts to experience is greater than under most Medicaid EHR payment incentive adopt, implement, or upgrade certified other rules for the following reason; program using the Medicaid Budget EHR technology and the meaningful use specifically, this rule provides the Expenditure System. Since States of said technology before making any option for States to participate in the already have to report Medicaid payments to providers. This burden has Medicaid certified electronic health expenditures to the Medicaid Budget already been discussed in our burden record technology incentive payment and Expenditure System, there is no explanation for § 495.10. program. To the extent that States need for States to develop and Proposed § 495.366(d)(1) states that participate more or less than assumed implement a reporting process. subject to paragraph § 495.332, the State here (that is, the number of States, EPs However, States will need to estimate must assure that State expenditures are and hospitals) the burden associated and report the expenditures related to claimed in accordance with, including may be greater than or less than the provider incentive payments and the but not limited to, applicable Federal estimated. cost of the administration of the laws, regulations and policy guidance. BILLING CODE 4120–01–P

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BILLING CODE 4120–01–C

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If you comment on these information certification criteria, standards, and almost certainly cause major changes in collection and recordkeeping implementation specifications for physician behavior, enrollee care, and requirements, please do either of the certification of EHR systems, and the other Medicare provider payments, but following: proposed rule on EHR certification the specific nature of these changes is Submit your comments electronically programs. Each rule will assess the exceptionally uncertain. Under a as specified in the ADDRESSES section of direct economic effects of the provisions current law scenario, the EHR this proposed rule; or submit your it creates. This proposed rule on incentives or payment adjustments comments to the Office of Information Medicare and Medicaid EHR Incentive would exert only a minor influence on and Regulatory Affairs, Office of Programs addresses the impacts related physician behavior relative to these very Management and Budget, Attention: to the actions taken by EPs or eligible large payment reductions. However, the CMS Desk Officer, [CMS–0033–P— hospitals to become meaningful users of Congress has legislatively avoided Meaningful Use] Fax: (202) 395–5806; or certified EHR technology, including physician payment reductions in each E-mail: [email protected]. purchasing or developing in-house of the past 7 years. Behavioral changes certified EHR technology or EHR resulting from these scheduled IV. Response to Comments technology modules. physician payment reductions are not Because of the large number of public A number of factors will affect the included in our estimate and likewise comments we normally receive on adoption of EHR systems and we do not assume any additional Federal Register documents, we are not demonstration of meaningful use. Many behavioral changes from EHR incentive able to acknowledge or respond to them of these are addressed in this analysis. payments for physicians. individually. We will consider all Readers should understand that these All of these factors taken together comments we receive by the date and forecasts are subject to substantial make it impossible to predict with time specified in the DATES section of uncertainty. Demonstration of precision the timing or rates of adoption this preamble, and, when we proceed meaningful use will depend in part on and ultimately meaningful use. with a subsequent document, we will the final provisions of these three Therefore, we present a range of respond to the comments in the rulemakings, which will depend in turn estimates, which capture how different preamble to that document. on comments we now solicit but have scenarios will impact overall costs. Our not yet received. These three rules deal ‘‘high’’ scenario of meaningful use V. Regulatory Impact Analysis primarily with standards and demonstration assumes that roughly a A. Overall Impact requirements for FYs 2011 and 2012, decade from now, nearly 100 percent of but overall rates of meaningful use of hospitals and 70 percent of EPs will be We have examined the proposed certified EHR technology will depend in ‘‘meaningful users’’ in the Medicare EHR impacts of this rule as required by part on future rulemakings issued by the incentive program. This estimate is Executive Order 12866, the Regulatory HHS. based on the substantial economic Flexibility Act (RFA), section 1102(b) of The HITECH Act provides incentives incentives created by the combined the Social Security Act regarding rural for the meaningful use of certified EHR direct and indirect factors affecting hospital impacts, the Unfunded technology. Additionally, the Medicaid providers. We appreciate that in the real Mandates Reform Act, Executive Order program also provides incentives for the world nothing is ever 100 percent, and 13132 on Federalism, and the adoption, implementation, and upgrade can even identify factors that would Congressional Review Act. of certified EHR technology. Payment certainly lead providers to forego Executive Order 12866 directs adjustments are incorporated into the implementing an EHR. For example, a agencies to assess all costs and benefits Medicare program for providers unable physician nearing retirement with a low of available regulatory alternatives and, to demonstrate meaningful use. The Medicare caseload might well decide to if regulation is necessary, to select absolute and relative strength of these is accept the relatively low adverse regulatory approaches that maximize unclear. For example, a provider with consequences of declining to net benefits (including potential relatively small Medicare billings will demonstrate meaningful use of certified economic, environmental, public health be less disadvantaged by payment EHR technology. Alternatively, EPs and and safety effects, distributive impacts, adjustments than one with relatively eligible hospitals and CAHs may choose and equity). A regulatory impact large Medicare billings. Another not to adopt EHRs if the total costs of analysis (RIA) must be prepared for uncertainty arises because there are purchasing certified EHRs and the total rules with economically significant likely to be ‘‘bandwagon’’ effects as the costs of complying with this rule are effects ($100 million or more in any 1 number of providers using EHRs rises, higher than the value of the total EHR year). This proposed rule is anticipated thereby inducing more participation in incentive payments (and adjustments, if to have an annual effect on the economy the incentives program, as well as applicable). However, we have no of $100 million or more, making it an greater adoption by entities (for reliable basis for estimating the rate of economically significant rule under the example, clinical laboratories) that are such ‘‘holdouts.’’ To emphasize the Executive Order and a major rule under not eligible for incentives or subject to uncertainties involved, we have also the Congressional Review Act. penalties, but do business with EHR created a ‘‘low’’ estimate for the Accordingly, we have prepared a RIA adopters. It is impossible to predict demonstration of meaningful use each that to the best of our ability presents exactly if and when such effects may year. This might best be viewed as a the costs and benefits of the proposed take hold. more pessimistic view of the rate at rule. We request comments on the One legislative uncertainty arises which adoption approaches 100 analysis provided in this proposed rule. because under current law, physicians percent. This proposed rule is one of three are scheduled for massive payment Both the high and low estimates are coordinated rulemakings undertaken to reductions under the sustainable growth based on current law. That is, we implement the goals and objectives of rate (SGR) formula for determining assume that the incentive payments and the HITECH Act related to the adoption Medicare payments. Under the current potential reimbursement reductions set and meaningful use of certified EHR law, physician payments will be forth in the HITECH Act will remain technology. The other two are HHS’s reduced by at least 21 percent beginning unchanged. We also assume that the interim final rule establishing in CY 2010. Such reductions would scheduled physician payment

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reductions will occur. We appreciate implement EHRs for a number of impact on a substantial number of small that this assumption reflects the reasons—lack of standards, lack of entities. In the healthcare sector, Small standard practice used in forecasts of interoperability, limited physician Business Administration size standards government spending (including effects acceptance, fear of maintenance costs, define a small entity as one with on the private sector) by the Boards of and lack of capital. Perhaps most between $7 million and $34 million in Trustees for the Hospital Insurance and importantly, adoption of EHR annual revenues. For the purposes of Supplementary Medical Insurance Trust technology necessitates major changes the RFA, essentially all non-profit Funds, the Social Security trustees, the in business processes and practices organizations are considered small Office of the Actuary in HHS, and the throughout a provider’s office or facility. entities, regardless of size. Individuals Congressional Budget Office. However, Business process reengineering on such and States are not included in the we note that if this assumption is a scale is not undertaken lightly. definition of a small entity. Since the rendered invalid by future However, the availability of the HITECH vast majority of Medicare providers Congressional action, the combination Act incentives, grants for technical (well over 90 percent) are small entities of positive and negative incentives in support, more consistent use of within the RFA’s definitions, it is the the HITECH Act are such that we standards and specified certification normal practice of HHS simply to believe adoption rates would differ from criteria, and other factors addressed in assume that all affected providers are those estimated in this RIA. this RIA are sure to increase the ‘‘small’’ under the RFA. In this case, There are many estimates of current adoption of EHR technology very most healthcare EPs, eligible hospitals, EHR adoption and usage rates. There are substantially over the next 10 years— and CAHs are either non-profit or meet at least two EHR functions— perhaps approaching complete adoption the SBA’s size standard for small e-prescribing and billing—for which for physicians, hospitals, and many business. We also believe that the effects adoption and usage rates for both other types of providers. of the incentives program on many and physicians and hospitals may exceed 50 Section II. of this proposed rule probably most of these affected entities percent. However, high estimates are describes the categories of EPs, eligible will be economically significant. misleading because they focus on hospitals, and CAHs under Medicare Accordingly, this RIA section, in particular elements, not on and Medicaid, and outlines the conjunction with the remainder of the comprehensive systems that provide a eligibility criteria, so those details are preamble, constitutes the required full range of functions, similar in scope not repeated here. Initial Regulatory Flexibility Analysis. to those established in the companion Overall, we expect spending under We welcome comments on the analysis. interim final rule that adopts standards, the EHR incentive program for transfer We believe that the adoption of EHRs implementation specifications, and payments to Medicare and Medicaid will have an impact on virtually every certification criteria for the technical providers to be between $14 and $27 EP and eligible hospital, as well as requirements and capabilities that EHR billion over 10 years (these estimates CAHs and some physicians and systems will need to meet in order to be include net payment adjustments for hospitals affiliated with MA plans. certified. Based on several peer- providers who do not achieve While the program is voluntary, in the reviewed studies, only a small meaningful use in 2015 and beyond in first 5 years it carries substantial proportion of physicians and hospitals the amount of ¥$2.3 billion to ¥$5.1 positive incentives that will make it have invested in EHR technology that billion). We have also estimated ‘‘per attractive to virtually all eligible encompasses such a broad range of entity’’ costs for EPs and eligible entities. Furthermore, entities that do functions. For example, a study entitled hospitals, which aggregate to total not demonstrate meaningful use of EHR ‘‘Electronic Health Records in spending. We estimate also that technology will be subject to significant Ambulatory Care—A National Survey of adopting entities will achieve dollar Medicare payment reductions after the Physicians’’ (Catherine DesRoches et al., savings at least equal to their total costs, fifth year. The anticipation of these New England Journal of Medicine, July and that there will be additional Medicare payment adjustments will also 3, 2008), found that in 2007 only ‘‘four benefits to society whose magnitude is motivate EPs, eligible hospitals, and percent of physicians reported having uncertain, but will certainly be many CAHs to adopt and meaningfully use an extensive, fully functional electronic- billions of dollars over time. certified EHR technology. records system, and 13 percent reported While implementation costs will be For some EPs and eligible hospitals, having a basic system.’’ (Additional significant for each participating entity, the EHR technology that they have in results from the same survey can be we anticipate that the short-term costs place before the HITECH requirements, found at the Department’s Health IT to demonstrate meaningful use of will be able to be upgraded to meet the Adoption Initiative Web site at http:// certified EHR technology will be criteria for certified EHR technology as healthit.hhs.gov/portal/server.pt? outweighed by the long-term benefits, defined for this program. These costs open=512&mode=2&cached=true& including practice efficiencies and may be minimal, involving no more objID=1152) Another study entitled improvements in medical outcomes. than a software upgrade. ‘‘Home-grown’’ ‘‘Use of Electronic Health Records in Although both cost and benefit EHR systems that might exist will also U.S. Hospitals’’ (Ashish Jha et al., New estimates are highly uncertain, we have require an upgrade to meet the HITECH England Journal of Medicine, April 16, prepared a RIA that to the best of our certification requirements. 2009) found that in 2007 ‘‘only 1.5 ability presents the costs and benefits of We believe that most EPs using EHR percent of U.S. hospitals have a the proposed rulemaking. systems will require significant changes comprehensive electronic-records to achieve certification and/or the EPs system * * * and an additional 7.6 B. Regulatory Flexibility Analysis will have to make process changes to percent have a basic system.’’ The Regulatory Flexibility Act (RFA) achieve meaningful use. Further, given Computerized order entry for drugs was requires agencies to prepare an Initial what we know about the current low fully implemented in only 17 percent of Regulatory Flexibility Analysis to levels of EHR adoption, we believe that hospitals. describe and analyze the impact of the majority of EPs will need to Most physicians and hospitals have proposed rule on small entities unless purchase certified EHR technology and not yet invested in the hardware, the Secretary can certify that the implement this new technology and software, testing and training to regulation will not have a significant have their staff trained on its use. The

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costs for implementation and complying meaningful use for FY 2011 and beyond. effects of adopting EHR on health care with the criteria of meaningful use Requirements that are too stringent providers, quite apart from the incentive could lead to higher operational could have the adverse effect of payments to be provided under this expenses. However, we believe that the preventing many EPs, eligible hospitals, rule. While economically significant, we combination of payment incentives and and CAHs from achieving meaningful do not believe that the net effect on long-term overall gains in efficiency will use and thus preventing them from individual providers will be negative compensate for the initial expenditures. receiving an incentive payment. Our over time except in very rare cases. (The Additionally EPs and eligible hospitals meaningful EHR use requirements for statute provides for hardship exemption will have to demonstrate meaningful 2011 are designed to encourage more in such cases.) Accordingly, we believe use of their certified EHR technology as widespread adoption of certified EHR that the object of the RFA to minimize defined in the preamble. Since the technology and allow more EPs, eligible burden on small entities are met by this definition for stage 1 meaningful use has hospitals, and CAHs to qualify for rule as proposed. We invite public not yet been finalized and may be incentives while they are also adjusting comments on the analysis and request altered due to public comment, it is their practice patterns and training staff any additional data that would help us difficult to determine how hard it will to operate the EHR technology in determine more accurately the impact be for providers to achieve meaningful preparation for more stringent on the EPs and eligible hospitals use. meaningful use requirements over time. affected by the proposed rule. We recognize that there may be 1. Number of Small Entities incremental costs that result from C. Small Rural Hospitals In total, we estimate that there are requiring additional functionality over Section 1102(b) of the Act requires us approximately 624,000 healthcare the base level defined in the ARRA. For to prepare a RIA if a rule would have organizations (EPs or eligible hospitals) example, ARRA does not require a significant impact on the operations of that will be affected by the incentive certified EHRs to include functionalities a substantial number of small rural program. These include hospitals and associated with administrative hospitals. This analysis must conform to physician practices as well as doctors of simplification, but we have proposed the provisions of section 603 of the medicine or osteopathy, dental surgery them in this rule. We have not been able RFA. For purposes of section 1102(b) of or dental medicine, podiatric medicine, to find research that allows us to the Act, we define a small rural hospital optometry or a chiropractor. quantify these incremental costs and as a hospital that is located outside of Additionally, eligible non-physicians request comments on possible estimates a metropolitan statistical area and has (such as certified nurse-midwives, etc.) or further sources of information that will be eligible to receive the Medicaid fewer than 100 beds. This proposed rule will help us develop estimates. would affect the operations of a incentive payments. We note that with regard to reporting substantial number of small rural Of the 624,000 healthcare of quality measures for purposes of hospitals because they are required to organizations we estimate will be demonstrating meaningful use, we adopt certified EHR technology by 2015, affected by the incentive program, we considered requiring EPs, eligible or face adjusted payments. As stated estimate that 94.71 percent will be EPs, hospitals, and CAHs to report quality above, we have determined that this 0.8 percent will be hospitals, and 4.47 measures electronically in the initial proposed rule would create a significant percent will be MAO physicians or year of the program; however, impact on a substantial number of small hospitals. We further estimate that EPs ultimately we determined that many will spend approximately $54,000 to providers would not be able to comply entities, and have prepared a Regulatory purchase a certified EHR and $10,000 with a requirement to report all quality Flexibility Analysis as required by the annually for ongoing maintenance, measures at the beginning of the RFA and, for small rural hospitals, while we estimate the hospitals will program. The alternative approach, section 1102(b) of the Act. Furthermore, spend approximately $5 million to consistent with the requirements of this any impacts that would arise from the purchase a certified EHR and $1 million proposed rule, is to require reporting of implementation of certified EHR annually for ongoing maintenance. See quality measures in phases. In 2011, technology in a rural eligible hospital the Assumptions section (section V.G.3 there will be a requirement to report would be positive, with respect to the of this proposed rule) for details on our quality measures through attestation streamlining of care and the ease of estimates for the number of entities that with a numerator and denominator. sharing information with other EPs to are eligible for the incentive, within Electronic quality measure reporting avoid delays, duplication, or errors. each eligibility type category (EPs and will begin in CY 2012. Additional D. Unfunded Mandates Reform Act eligible hospitals). quality measure reporting will be added Section 202 of the Unfunded 2. Alternatives Considered in later years. Under Medicaid, we considered Mandates Reform Act of 1995 (UMRA) This proposed rule implements new numerous alternatives regarding how to requires that agencies assess anticipated provisions of the Act for providing demonstrate eligibility for the incentive costs and benefits before issuing any incentives for EPs, eligible hospitals, payments as well as adoption and rule whose mandates would require and CAHs that adopt and meaningfully meaningful use of the certified EHR spending in any 1 year $100 million in use certified EHR technology. HHS has technology. These alternatives, 1995 dollars, updated annually for no discretion to change the incentive including the period for demonstrating inflation. In 2009, that threshold is payments or payment reductions adequate patient volume, and the approximately $130 million. UMRA specified in the statute for providers requirements and methods for does not address the total cost of a rule. that adopt or fail to adopt EHR and demonstrating meaningful use are Rather, it focuses on certain categories achieve meaningful use of EHR discussed in section II.D. of this of cost, mainly those ‘‘Federal mandate’’ technology. The only substantial proposed rule. costs resulting from—(1) imposing alternatives within the discretion of the enforceable duties on State, local, or Department revolve around how best to 3. Conclusion tribal governments, or on the private meet the requirements of the HITECH As discussed later in this analysis, we sector, or (2) increasing the stringency of Act regarding requirements for believe that there are many positive conditions in, or decreasing the funding

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of, State, local, or tribal governments implemented to track and report on requires that certified EHRs have the under entitlement programs. provider attestations, applications, and capability to support CPOE, we have This rule imposes no substantial payments. States will also expend funds used our discretion in developing the mandates on States. The State role in on the systems that must be built to ‘‘CPOE use’’ measure discussed in the incentive program is essentially to conduct the tracking and reporting section III. administer the Medicaid incentive activities. However, the Federal share of We have not been able to find program. While this entails certain the 90 percent match will protect the research that allows us to quantify these procedural responsibilities, these do not States from burdensome financial incremental costs and request comments involve substantial State expense. In outlays. on possible estimates or further sources general, each State Medicaid Agency F. Anticipated Effects of information that will help us develop that participates in the incentive estimates (please refer to the analysis program will be required to invest in The objective of the remainder of this below as well as to the rightmost systems and technology to comply— RIA is to summarize the costs and column in Table 33). In addition, we States will have to identify and educate benefits of the HITECH incentive welcome information on benefits of providers, evaluate their attestations program for the Medicare FFS, specific provisions of this rule so that and pay the incentive. However, the Medicaid, and Medicare Advantage we can conduct, for the final rule, a Federal government will fund 90 (MA) programs. We also provide more robust assessment of alternatives percent of the cost, providing controls assumptions and a narrative addressing comparing incremental costs and on the total State outlay. the potential costs to the industry for benefits of each requirement. The investments needed to meet the implementation of this technology. meaningful use standards and obtain 3. Background and Assumptions G. HITECH Impact Analysis incentive funding are voluntary, and The principal costs of this proposed hence not ‘‘mandates’’ within the 1. Need for Regulation rule are the additional expenditures that meaning of the statute. However, the will be undertaken by eligible entities in potential reductions in Medicare This proposed rule would implement order to obtain the Medicare and reimbursement after FY 2015 are the provisions of the American Medicaid incentive payments to adopt effectively mandates. We note that we Recovery and Reinvestment Act of 2009 and demonstrate meaningful use of have no discretion as to those potential (ARRA) (Pub. L. 111–5) that provide certified EHR technology, and to avoid payment reductions. Private sector EPs incentive payments to eligible the Medicare payment adjustments that that voluntarily choose not to professionals (EPs) and eligible will ensue if they fail to do so. The participate in the program may hospitals participating in Medicare and estimates for the provisions affecting anticipate potential costs in the Medicaid programs that adopt and aggregate that may exceed $130 million; meaningfully use certified electronic Medicare and Medicaid EPs, eligible however, because EPs may choose for health record (EHR) technology. The hospitals, and CAHs are somewhat various reasons not to participate in the proposed rule would specify the—initial uncertain for several reasons: (1) The program, we do not have firm data for criteria an EP and eligible hospital must program is voluntary although payment the percentage of participation within meet in order to qualify for the incentive adjustments will be imposed on the private sector. payment; calculation of the incentive Medicare providers who are unable to This RIA, taken together with the payment amounts; payment adjustments demonstrate meaningful use starting in remainder of the preamble, constitutes under Medicare for covered professional 2015; (2) the criteria for the the analysis required by UMRA. We services and inpatient hospital services demonstration of meaningful use of welcome comments on any aspects of provided by EPs and eligible hospitals certified EHR technology have not been this proposed rule that mandate costs failing to meaningfully use certified finalized and will change over time; (3) that could be reduced or ameliorated. EHR technology; and other program HHS has not yet defined certified EHR participation requirements. technology; (4) the impact of the E. Federalism financial incentives and payment Executive Order 13132 establishes 2. Alternatives Considered adjustments on the rate of adoption of certain requirements that an agency As previously discussed in the certified EHR technology by EPs, must meet when it promulgates a alternatives section of the regulatory eligible hospitals, and CAHs, is difficult proposed rule (and subsequent final flexibility analysis, HHS has no to predict; and (5) the ultimate impact rule) that imposes substantial direct discretion to change the incentive of certified EHR technology on requirement costs on State and local payments or payment reductions expenditures for medical treatments (for governments, preempts State law, or specified in the statute for providers example, reducing errors, expedited otherwise has Federalism implications. that adopt or fail to adopt EHR and treatment) cannot be known with This proposed rule would not have a achieve meaningful use of EHR certainty at this time. The net costs and substantial direct effect on State or local technology. However, the Department savings shown for this program governments, preempt State law, or has discretion around how best to meet represent a range of possible scenarios, otherwise have a Federalism the HITECH Act requirements for and actual impacts could differ. We implication. Importantly, State meaningful use for FY 2011 and beyond. welcome public input on all aspects of Medicaid agencies are receiving 100 We recognize that there may be the costs and benefits of this proposed percent match from the Federal additional costs that result from various rule. government for incentives paid and a 90 discretionary policy choices such as As written in the preamble, this percent match to administer the requiring additional functionality over proposed rule describes the incentive program. As previously stated, we the base level defined in the ARRA. For payments for EPs, eligible hospitals, and believe that those administrative costs example, ARRA does not require CAHs for adopting and demonstrating are minimal. We note that this proposed certified EHRs to include functionalities meaningful use of certified EHR rule does add a new business associated with administrative technology. This impact analysis requirement for States, because of the simplification, but we have proposed addresses the costs and benefits to the systems that will need to be them in this rule. While ARRA also Medicare and Medicaid programs, as

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well as general implementation costs for average would be $5 million for 85 percent of the net average allowable eligible hospitals and EPs. installation. We estimate $1 million for costs of certified EHR technology, with Detailed information about the maintenance, upgrades, and training such net average allowable costs capped incentive program, the specific payment each year. Though we cite these existing at $25,000 in the first year (for the amounts and how those payments will studies, we realize that these estimates purchase, implementation or upgrade of be paid, is provided in section II. of this vary widely, in part, because different certified EHR technology) and $10,000 proposed rule. Based on input from a providers have adopted different types in each of the subsequent years. number of internal and external sources, of EHRs, each with their own set of a. Costs of EHR Adoption for EPs including the Government functionalities. Because providers who Accountability Office (GAO) and CBO, would like to qualify as ‘‘meaningful Previously, we described four studies we calculated the numbers of EPs and users’’ of EHRs will need to purchase used to estimate costs of eligible hospitals under Medicare, ‘‘certified EHRs,’’ we further implementation including the purchase Medicaid, and MA and used them acknowledge that ‘‘certified EHRs’’ may and installation of hardware and throughout the analysis. differ in many important respects from software, training, as well as • About 553,200 original Medicare the types of EHRs used in these studies productivity losses associated with FFS EPs in 2011 (some of which will and the functionalities they contained. implementation and training. Each of also be Medicaid EPs). For that reason, we welcome industry these studies was conducted several • About 27 percent of the total EPs input on the costs of implementing and years ago, and did not control for type are hospital-based Medicare EPs, and maintaining certified EHR technology. of EHR, functionality, physician are not eligible for the program. This We would be particularly interested in practice type or size. Furthermore, EHRs leaves approximately 404,400 estimates of what a ‘‘qualified EHR’’ as were not being built against any nonhospital-based Medicare EPs in defined in ARRA would cost (that is, an particular consensus standard, nor was 2011. EHR with the capability to collect and the concept of ‘‘meaningful use’’ a factor. • Twenty percent of the nonhospital- store patient demographic data and Thus, the cost of implementing and based Medicare EPs (approximately support CPOE, clinical decision maintaining certified EHR technology 80,900 Medicare EPs in 2011) are also support, and registry functions) for both which meets the requirements eligible for Medicaid (meet the 30 EPs and hospitals. To the extent that established in this regulation might percent Medicaid patient volume there may be additional costs that result exceed the estimates from these studies. criteria) but can only be paid under one from various discretionary policy One average estimate of the cost per program. Any EP in this situation will choices in this rulemaking, such as physician for implementation is around choose to receive the Medicaid requiring additional functionality over $35,000. Therefore, in a practice with incentive payment, because it is larger. the base level defined in the ARRA, we five physicians, the cost could be • About 38,200 non-Medicare eligible would be interested to know what those $175,000. A similar study of community EPs (such as dentists, pediatricians, and incremental additional costs may be. health centers estimated costs to average eligible non-physicians such as certified Industry costs are important, in part, $54,000 per physician FTE. In this nurse-midwives, nurse practitioners and because EHR adoption rates will be a study, the authors explained that physicians assistants) will be eligible to function of these industry costs and the implementation costs varied between receive the Medicaid incentive extent to which the costs of ‘‘certified entities for hardware, software, payments. EHRs’’ are higher than the total value of installation, and training. After • 5,011 eligible hospitals, comprised EHR incentive payments available to implementation, there were ongoing of the following: EPs and eligible hospitals (as well as operating costs estimated at $21,000 per ++ 3,620 acute care hospitals. adjustments, in the case of the Medicare year for a practice of four physicians. ++ 1,302 CAHs (Medicare only). EHR incentive program) and any The CBO paper, Evidence on the Costs ++ 78 children’s hospitals (Medicaid perceived benefits including societal and Benefits of Health Information only). benefits. Because of the uncertainties Technology, May 2008, in attempting to ++ 11 cancer hospitals (Medicaid surrounding industry cost estimates, we estimate the total cost of implementing only). have made various assumptions about health IT systems in office-based • All eligible hospitals, except for adoption rates in the following analysis medical practices, recognized the children’s and cancer hospitals, may in order to estimate the budgetary complicating factors of EHR types, qualify and apply for both Medicare and impact on the Medicare and Medicaid available features and differences in Medicaid incentive payments. programs. We welcome comments on characteristics of the practices that are • 12 MA Organizations (about 28,000 our estimates, including costs estimates adopting them. The CBO estimated a EPs, and 29 hospitals) would be eligible and adoption rate estimates. cost range of $25,000 to $45,000 per for incentive payments. For an eligible Medicaid EP, the first physician. In the CBO study, operating • Payments can begin as early as FY year incentive is based in part on the costs added $3,000 to $9,000 per 2011. adoption, implementation, and upgrade physician per year. Finally, a 2005 costs. Previously, we noted that section paper from AHRQ stated that the 4. Industry Costs and Adoption Rates 1903(t)(4)(C) of the Act gives the average purchase and implementation To estimate the impact on healthcare Secretary the authority to determine cost of an EHR could be $32,606 per providers we used information from average allowable costs for certified FTE physician. Maintenance costs were four studies cited previously. Based on EHR technology. The Secretary is to an additional $1,500 per physician, per these studies, we estimate for EPs, the study average costs associated with the month, or $18,000 per year. Smaller average adopt/implement/upgrade cost purchase, initial implementation, and practices had the highest is $54,000 per physician FTE, while upgrade of certified EHR technology, implementation costs per physician at annual maintenance costs average including support services and initial $37,204. Based on the studies cited, $10,000 per physician FTE. For all training. eligible providers will be eligible to eligible hospitals, the range is from $1 Sections 1903(t)(1)(A) and 1903(t)(4) receive the maximum incentive million to $100 million. Though reports of the Act specify that EPs may not permitted under the statute, because the vary widely, we anticipate that the receive incentive payments in excess of implementation and maintenance costs

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we have estimated exceed the caps for hospitals had an EHR system that needed to determine the EPs with net average allowable costs set in the includes physician and nursing notes, Medicare claims. Then, we calculated statute. but these systems did not have decision that about 27 percent of those EPs are In calculating the impact of the EHR support. Some 10.9 percent have a basic hospital-based based on the definition incentive program for Medicaid EPs, we system that does not include physician proposed in § 495.6, and therefore, do assumed that approximately 20 percent and nursing notes, and can only be used not qualify for incentive payments. of the EPs eligible for the Medicare in one area of the hospital. Researchers They are subtracted from the total incentive payment program are also found that 17 percent of the hospitals number of EPs who have claims with eligible for Medicaid EHR incentive had the capacity for e-prescribing, a key Medicare. These numbers were payments (about 80,000 in 2011). Since feature in any modern day system. tabulated from Medicare claims data. the Medicaid incentive payments are According to hospital CEOs, the main We have also estimated that about 20 higher than those for Medicare are and barrier to adoption is the cost of the EPs can only receive payments from on systems, and the lack of capital. percent of EPs that are not hospital- program, we assume the dually eligible Hospitals have been concerned that they based will qualify for Medicaid EPs will receive their payments through will not be able to recoup their incentive payments and will choose that the Medicaid program. Medicaid also investment, and they are already program because the payments are offers incentive payments for operating on the smallest of margins. higher. Of the remaining EPs, we have pediatricians, dentists, certified nurse- Because uptake is low, it is difficult to estimated the percentage which will be midwives, nurse practitioners and get a solid average estimate for meaningful users each calendar year. As certain physicians’ assistants. While implementation and maintenance costs discussed previously our estimates for minimal, we have incorporated the sum that can be applied across the industry. the number of EPs that will successfully of these groups in Table 51. We have Although we have provided some demonstrate meaningful use of certified estimated a range of Medicaid EPs that estimates on implementation/upgrade EHR technology are uncertain, so we will be meaningful users each calendar costs in this analysis, we recognize that established high and low scenario to year. The last line represents the range there are additional industry costs account for high and low rates of of predicted meaningful EHR users each associated with adoption and demonstration of meaningful use. calendar year. The Medicaid penetration implementation of EHR technology that rate for EPs is consistent with the are not captured in our estimates that The percentage of Medicare EPs who analysis that was used for the Medicare eligible entities will incur. Because the will satisfy the criteria for EPs, but without the behavioral impact of those activities, such as demonstrating meaningful use of limitations imposed by the Medicare reduced staff productivity related to certified EHR technology and will current statute SGR payment reductions. learning how to use the EHR qualify for incentive payments is a key, We assumed a modest behavioral technology, the need to add additional but highly uncertain factor. Our response by Medicaid EPs to the staff to work with HIT issues, Medicare EHR adoption assumptions for Medicaid incentive payments resulting administrative costs related to reporting, EPs are also affected by the current in an increase over baseline and the like are unknown at this time situation with Medicare physician fee participation. and difficult to quantify, we invite schedule payment rates. As noted public comment and additional previously, under current law (that is, b. Costs of EHR Adoption for Eligible information to assist in our analysis. We the SGR system formulas), physician Hospitals also note that there may be EPs that payments will be reduced by at least 21 In 2006, the AHA conducted a survey voluntarily choose not to participate in percent beginning in CY 2010. Such to evaluate annual hospital costs: the the program, and that those EPs may reductions would almost certainly cause range was enormous—ranging from anticipate potential costs resulting from major changes in physician behavior, $30,500 to $93.8 million, with a median that decision. Therefore, we have set a enrollee care, and other Medicare placeholder in our accounting statement amount of $3.8 million. In another provider payments, but the specific article from HealthDayNews, EHR at this time and request public comment nature of these changes is exceptionally system costs were reported by experts to on industry costs on those that may or uncertain. Under a current law scenario, run as high as $20 million to $100 may not choose to implement the million; HHS discussions with experts program that could inform our analysis the EHR incentives or payment led to cost ranges for adoption that for the final rule. adjustments would exert only a minor varied by hospital size and level of EHR We did not include cost estimates on influence on physician behavior relative system sophistication. Research to date Federal hospitals in this analysis, since to these very large payment reductions. has shown that adoption of the Veterans Affairs hospitals have Behavioral changes resulting from these comprehensive EHR systems is limited. already implemented comprehensive scheduled payment reductions are not In the AHA study, nearly 3,050 U.S. electronic health record systems. There included in our estimate and likewise hospitals were surveyed about the use of may be costs if those systems have to be do not assume any additional behavioral EHR systems. Only 1.5 percent of these significantly upgraded to meet the changes from EHR incentive payments. organizations had comprehensive certification criteria, but no estimates Accordingly, the estimated number of systems, which were defined as were gathered for this analysis. nonhospital based Medicare EPs who hospital-wide clinical documentation of 5. Medicare Incentive Program Costs will demonstrate meaningful use of cases, test results, prescription and test a. Medicare Eligible Professionals (EPs) certified EHR technology over the ordering, plus support for decision- period CYs 2011 through 2019 is as making that included treatment To determine the estimated costs of shown in Table 35. guidelines. Almost eight percent of the Medicare incentives for EPs we first

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TABLE 35—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, HIGH AND LOW SCENARIO

Calendar year 2011 2012 2013 2014 2015 2016 2017 2018 2019

EPs who have claims with Medicare (thou- sands) ...... 553.2 558.9 564 .6 570.3 576.0 581.7 587.5 593 .3 599.0 Non-Hospital Based EPs (thousands) ..... 404.4 408.6 412.7 416.9 421 .1 425.3 429.5 433.7 437.9 EPs that are both Medicare and Med- icaid EPs (thou- sands) ...... 80.9 81 .7 82 .5 83 .4 84 .2 85.1 85 .9 86 .7 87 .6 Low Scenario: Percent of EPs who are Mean- ingful Users..... 10 13 15 18 21 24 28 32 36 Meaningful Users (thousands) ...... 33 .8 41 .3 49.8 59 .5 70 .3 82 .4 95 .6 110.0 125 .4 High Scenario: Percent of EPs who are Mean- ingful Users..... 36 40 44 49 53 58 62 66 70 Meaningful Users (thousands) ...... 115.8 131.0 146 .8 163.1 179.7 196.4 212.9 229 .0 244.6

Under the HITECH Act, EPs can payable after CY 2016, and EPs who first Our estimates of the incentive receive up to 5 years of Medicare demonstrate meaningful use in CY 2015 payment costs and payment adjustment incentive payments for the meaningful or later are not eligible for EHR savings reflect our assumptions about use of certified EHR technology. These incentive payments. the proportion of EPs who will payments are the lesser of 75 percent of Medicare payment adjustments will demonstrate meaningful user of certified the physician’s allowed charges for the apply in CY 2015 and later to EPs who EHR technology. These assumptions year or a specified maximum amount, cannot demonstrate meaningful use of were developed based on a review of which declines from a possible $18,000 certified EHR technology, regardless of recent studies and discussions with incentive payment for the first payment whether they received an EHR incentive subject matter experts. We project that year to a $2,000 incentive payment for payment or not. Specifically, the a growing proportion of EPs will adopt the fifth payment year. EPs in HPSAs Medicare Physician Fee Schedule certified EHR technology that meets the receive incentives that are 10 percent payments for an EP who cannot standards even in the absence of the higher than the maximum amounts. demonstrate meaningful use of certified legislated incentives. This number Hospital-based EPs are not eligible for EHR technology would be reduced by 1 could be higher or lower depending on the Medicare EP incentive payments. percentage point in CY 2015, two the final meaningful use definition EPs may choose to receive incentive percentage points in CY 2016, and 3 adopted, physicians’ access to capital payments from either Medicare or percentage points in CY 2017, and and implementation expertise, the Medicaid, but not from both. between 3 and 5 percentage points in success of the other HITECH programs The standard full amount of Medicaid starting in CY 2018. The HITECH Act in reaching physicians, and other incentive payments that an EP could gives the Secretary the authority, factors. receive is larger than the standard full beginning in CY 2018, to increase these Specifically, our assumptions are amount for the Medicare EP incentive reductions by 1 percentage point each based on literature estimating current payments: about $65,000 versus $44,000 year, but not more than 5 percentage rates of physician EHR adoption and for Medicare. Details about the points overall, if the Secretary finds the rates of diffusion of EHRs and similar Medicaid payments are described in the proportion of EPs who are meaningful technologies. There are a number of section V.G.3 of this proposed rule. EHR users is less than 75 percent. studies that have attempted to measure Medicare incentive payments can first Each year a transfer will be made the rate of adoption of electronic be paid to EPs in CY 2011; and 2012 is between the general fund of the medical records (EMR) among the last year that an EP can start to Treasury and the Part B account of the physicians prior to the enactment of the receive incentives and obtain the full 5 Supplemental Medical Insurance (SMI) HITECH Act (see, for example, Funky years of payments. EPs who first qualify trust fund to offset the incentives paid and Taylor (2005) The State and Pattern in CY 2013 would be limited to an or payment adjustments made during of Health Information Technology incentive of $15,000 for the first year, the year. In this way, the Part B Adoption. RAND Monograph MG–409. and may be eligible to receive 4 years beneficiary premium will not be Santa Monica: The RAND Corporation; of incentive payments. EPs who first affected by the EP payment incentives. Ford, E.W., Menachemi, N., Peterson, qualify in CY 2014 would be limited to We estimate that there are 12 MA L.T., Huerta, T.R. (2009) ‘‘Resistance is an incentive of $12,000 for the first year plans that might be eligible to Futile: But it is Slowing the Pace of EHR and may be may be eligible to receive participate in the EHR incentive Adoption Nonetheless’’ Journal of the 3 years of incentive payments. For the program. Those plans have about 28,000 American Informatics Association 16(3): Medicare program, incentives are not EPs. 274–281). We took the estimated rate of

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EHR adoption from the study with the underway. We assumed that the same However, actual adoption trends most rigorous definition, assuming that proportion of them would be could be significantly different from meaningful use would be a standard at implementing fully-functional EHRs as these assumptions, given the elements least as strict as that one (DesRoches, in the baseline (30 percent of those with of uncertainty we describe throughout CM, Campbell, EG, Rao, SR et al. (2008) basic systems.) We then trended this this analysis. ‘‘Electronic Health Records in number forward using the trajectory The estimated net costs for the low Ambulatory Care—A National Survey of mapped out by Ford et al. using the data Physicians’’ New England Journal of from the period prior to FY 2004 since scenario of the Medicare EP portion of Medicine 359(1): 50–60). We then the slower rate of adoption during the the HITECH Act are shown in Table 36. inflated that number (4 percent) to a FY 2005 through 2007 period was This provision is estimated to decrease 2011 baseline using the numbers of thought to be caused by policy Part B expenditures by a net total of $0.6 physicians reporting in that survey that uncertainty which this regulation billion during FYs 2011 through 2019. they had EHR implementation should resolve.

TABLE 36—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, LOW SCENARIO [In billions]

Payment Fiscal year Incentive adjustment Benefit Net total payments receipts payments

2009 ...... 2010 ...... 2011 ...... $0.1 ...... $0.1 2012 ...... 0.9 ...... 0.9 2013 ...... 0.8 ...... 0.8 2014 ...... 0.7 ...... 0.7 2015 ...... 0.5 ¥$0.4 ...... 0.1 2016 ...... 0.3 ¥0.6 ...... ¥0.3 2017 ...... 0.1 ¥0.9 ...... ¥0.8 2018 ...... ¥1.0 ...... ¥1.0 2019 ...... ¥1.1 ...... ¥1.1

Total, 2009–2014 ...... 2.4 ...... 2.4 Total, 2009–2019 ...... 3.2 ¥3.9 ...... ¥0.6

The estimated net costs for the high the HITECH Act are shown in Table 37. Part B expenditures by a net total of $5.4 scenario of the Medicare EP portion of This provision is estimated to increase billion during FYs 2011 through 2019.

TABLE 37—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, HIGH SCENARIO [In billions]

Payment Fiscal year Incentive adjustment Benefit Net total payments receipts payments

2009 ...... 2010 ...... 2011 ...... $0.3 ...... $0.3 2012 ...... 2.2 ...... 2.2 2013 ...... 1.8 ...... 1.8 2014 ...... 1.5 ...... 1.5 2015 ...... 1.0 ¥$0.2 ...... 0.8 2016 ...... 0.6 ¥0.3 ...... 0.2 2017 ...... 0.1 ¥0.5 ...... ¥0.4 2018 ...... ¥0.5 ...... ¥0.5 2019 ...... ¥0.5 ...... ¥0.5

Total, 2009–2014 ...... 5.8 ...... 5.8 Total, 2009–2019 ...... 7.5 ¥2.1 ...... 5.4

b. Medicare Eligible Hospitals meaningful use, and then making eligible hospitals was to determine the assumption about how rapidly hospitals amount of Medicare incentive payments In brief, the estimates of hospital would adopt given the fraction of their that each hospital in the country could adoption were developed by calculating costs that were covered. potentially receive under the statutory projected incentive payments (which Specifically, the first step in preparing formula, based on its admission are driven by discharges), comparing numbers (total patients and Medicare them to projected costs of attaining estimates of Medicare program costs for

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patients). The total incentive payments of EHR adoption in that class of implemented relatively advanced potentially payable over a 4-year period hospitals. Hospitals were grouped first systems that included CPOE systems for vary significantly by hospitals’ inpatient by size (CAHs, non-CAH hospitals medications; (2) hospitals which had caseloads, ranging from a low of about under 400 beds, and hospitals with 400 implemented more basic systems $9,000 to a high of $10.4 million, with or more beds) because EHR adoption through which lab results could be the median being $3.6 million. The costs do vary by size: namely, larger shared, but not CPOE for medications; potential Medicare incentive payments hospitals with more diverse service and (3) hospitals starting from a base for each eligible hospital were compared offerings and powerful physician staffs level either neither CPOE or lab with the hospital’s expected cost of generally implement more customized reporting. The CPOE for medication purchasing and operating certified EHR systems than smaller hospitals that standard was chosen because expert technology. Costs of adoption for each might purchase off-the-shelf products. input indicated that the CPOE standard hospital were estimated using data from We then calculated the proportion of in the proposed meaningful use the 2007 AHA annual survey and IT hospitals within each class that were at definition will be the hardest one for supplement. Estimated costs varied by one of three levels of EHR adoption: (1) hospitals to meet. Table 38 provides size of hospital and by the likely status Hospitals which had already these proportions.

TABLE 38—HOSPITAL IT CAPABILITIES BY HOSPITAL SIZE

Levels of adoption

Hospital size Any CPOE meds Lab results Neither Total Number of Number of Number of Number of hospitals Percentage hospitals Percentage hospitals Percentage hospitals Percentage

CAHs ...... 146 18 372 47 274 35 792 23 Small/Medium ...... 683 30 1,268 55 359 16 2,310 67 Large (400+ beds) ...... 169 49 162 47 17 5 348 10

Total ...... 998 29 1802 52 650 19 3,450 100

We then calculated the costs of and are adjusted by transition factors of cannot demonstrate meaningful use of moving from these stages to meaningful 100, 75, 50, and 25 percent for the first certified EHR technology. Special rules use for each class of hospital, assuming through fourth implementation years apply to CAHs. that even for hospitals with CPOE respectively. Medicare incentive We estimate that there are 12 MAOs systems they would incur additional payments can first be paid to hospitals that might be eligible to participate in costs of at least 10 percent of their IT in FY 2011, and FY 2013 is the last year the incentive program. Those plans have budgets. These costs were based on that a hospital can start to receive 29 eligible hospitals. The costs for the cross-sectional data from the AHA incentives and obtain the full 4-year MA program have been included in the survey and thus do not likely represent transition rates. Eligible hospitals that overall Medicare estimates. the true costs of implementing systems. first qualify in FY 2014 or FY 2015 will We request public input on the costs of Again due to uncertainties, we are only receive the transition portions that adoption and attaining the meaningful providing ranges for our estimates. Our use standard and the determinants of apply to eligible hospitals who high scenario estimated net costs for those costs. implement their EHR in FY 2013 (for section 4102 of the HITECH Act are Under the HITECH Act, an eligible example, 75 percent in FY 2014 and 50 shown in Table 39: Estimated costs (+) hospital can receive up to 4 years of percent in FY 2015). Eligible hospitals and savings (–) for eligible hospitals Medicare incentive payments for the that first demonstrate meaningful use in adopting certified EHRs. This provision demonstration of meaningful use of FY 2016 or later are not eligible for is estimated to increase Medicare certified EHR technology. These incentive payments. Payment hospital expenditures by a net total of payments reflect the ratio of Medicare adjustments will be applied beginning $11.2 billion during FYs 2011 through inpatient days to total inpatient days in FY 2015 to eligible hospitals that 2019.

TABLE 39—ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, HIGH SCENARIO [In billions]

Payment Fiscal year Incentive adjustment Benefit Net total payments receipts payments

2009 ...... 2010 ...... 2011 ...... $2.4 ...... (1) $2.4 2012 ...... 2.7 ...... (1) 2.7 2013 ...... 2.4 ...... (1) 2.4 2014 ...... 2.3 ...... (1) 2.3 2015 ...... 1.3 ¥$0.1 (1) 1.2 2016 ...... 0.5 ¥0.1 (1) 0.4 2017 ...... (1) (1)

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TABLE 39—ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, HIGH SCENARIO—Continued [In billions]

Payment Fiscal year Incentive adjustment Benefit Net total payments receipts payments

2018 ...... (1) (1) 2019 ...... (1) (1)

Total, 2009–2014 ...... 9.8 ...... –0.1 9.7 Total, 2009–2019 ...... 11.6 –$0.2 –0.2 11.2 1 Savings of less than $50 million.

We are also providing the estimates for a low scenario in Table 40.

TABLE 40—ESTIMATED COSTS (+) AND SAVINGS (–) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY, LOW SCENARIO [In billions]

Payment Fiscal year Incentive adjustment Benefit Net total payments receipts payments

2009 ...... 2010 ...... 2011 ...... $1.7 ...... (1) $1.7 2012 ...... 1.6 ...... (1) 1.6 2013 ...... 1.5 ...... (1) 1.5 2014 ...... 1.8 ...... (1) 1.8 2015 ...... 1.4 –$0.4 (1) 1.0 2016 ...... 0.6 –0.3 (1) 0.3 2017 ...... ¥0.3 (1) ¥0.3 2018 ...... ¥0.2 (1) ¥0.2 2019 ...... (1) (1)

Total, 2009–2014 ...... 6.6 ...... –$0.1 6.5 Total, 2009–2019 ...... 8.6 –1.1 –0.2 7.4 1 Savings of less than $50 million.

Based on the comparison of Medicare 2018. As indicated, eligible hospitals implement an EHR system if they incentive payments and that could cover the full cost of an EHR perceive that a large portion of the costs implementation/operating costs for each system through Medicare incentive will be covered by the incentive eligible hospital (described above), we payments were assumed to implement payments. Table 41 shows the high made the assumptions shown in Table them relatively rapidly, and vice-versa. scenario estimates: 41, related to the prevalence of certified In other words, eligible hospitals will EHR technology for FY 2011 through have an incentive to purchase and

TABLE 41—ASSUMED PROPORTION OF ELIGIBLE HOSPITALS WITH CERTIFIED EHR TECHNOLOGY, BY PERCENTAGE OF SYSTEM COST COVERED BY MEDICARE INCENTIVE PAYMENTS, HIGH SCENARIO

Incentive payments as percentage of EHR technology cost Fiscal year 100+% 75–100% 50–75% 25–50% 0–25%

2011 ...... 0 .8 0 .5 0 .3 0 .2 0 .1 2012 ...... 0 .95 0.65 0.5 0.35 0 .2 2013 ...... 1 .0 0 .8 0 .7 0 .6 0 .4 2014 ...... 1 .0 0 .95 0.85 0.75 0 .6 2015 ...... 1 .0 1 .0 0 .95 0.9 0.8 2016 ...... 1 .0 1 .0 1 .0 0 .95 0.9 2017 ...... 1 .0 1 .0 1 .0 1 .0 0 .95 2018 ...... 1 .0 1 .0 1 .0 1 .0 1 .0

For instance, under the high scenario incentive payments would cover the cost of a certified EHR system were 50 percent of eligible hospitals whose between 75 percent and 100 percent of assumed to have a certified system in

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FY 2011. In FY 2012, 65 percent of updates would be reduced (on a payer demand will limit the number of those hospitals were assumed to have a noncumulative basis) by one-fourth, hospitals that can adopt advanced certified EHR system. All such hospitals one-half, and three-fourths for FYs 2015, systems in the short term. Therefore, we were assumed to have a certified EHR 2016, and 2017 and later, respectively, cannot be certain of the adoption rate system in FY 2015 and thereafter. for eligible hospitals that were not for hospitals due to these factors and High rates of EHR adoption are meaningful users of certified EHR others previously outlined in this anticipated prior to FY 2015 due to the technology. However, we heard from preamble, and so we provide a range large payment adjustments that will be industry experts that issues surrounding which reflects what we believe are imposed on eligible hospitals that are the capacity of vendors and expert reasonably anticipated low to high rates unable to demonstrate meaningful use consultants to support implementation, of adoption. beginning in FY 2015. Specifically, the issues of access to capital, and Table 42 shows the low scenario Medicare ‘‘market basket’’ payment competing priorities in responding to estimates.

TABLE 42—ASSUMED PROPORTION OF ELIGIBLE HOSPITALS WITH CERTIFIED EHR TECHNOLOGY, BY PERCENTAGE OF SYSTEM COST COVERED BY MEDICARE INCENTIVE PAYMENTS, LOW SCENARIO

Incentive payments as percentage of EHR technology cost Fiscal year 100+% 75–100% 50–75% 25–50% 0–25%

2011 ...... 0 .6 0 .35 0.2 0.2 0.05 2012 ...... 0 .65 0.4 0.25 0.15 0 .1 2013 ...... 0 .75 0.55 0.4 0.25 0 .15 2014 ...... 0 .9 0 .75 0.55 0.4 0.3 2015 ...... 1 .0 0 .9 0 .75 0.6 0.5 2016 ...... 1 .0 1 .0 0 .9 0 .85 0.75 2017 ...... 1 .0 1 .0 0 .95 0.9 0.85 2018 ...... 1 .0 1 .0 1 .0 0 .95 0.9 2019 ...... 1 .0 1 .0 1 .0 1 .0 1 .0

For large, organized facilities such as assumptions about incentive payments EHR technology by FY 2019. Table 43 hospitals, we believe that the revenue as percentages of EHR technology costs shows our high scenario estimated range losses caused by these payment in Table 42, we estimated that the great of percentages of the total potential adjustments would be a substantial majority of eligible hospitals would incentive payments associated with incentive to adopt certified EHR qualify for at least a portion of the eligible hospitals that could technology, even in instances where the Medicare incentive payments that they demonstrate meaningful use of EHR Medicare incentive payments would could potentially receive, and only a systems. Also shown are the estimated cover only a portion of the costs of modest number would incur penalties. percentages of potential incentives that purchasing, installing, populating, and Nearly all eligible hospitals are would actually be paid each year. operating the EHR system. Based on the projected to have implemented certified

TABLE 43—ESTIMATED PERCENTAGE OF MEDICARE INCENTIVES WHICH COULD BE PAID FOR MEANINGFUL USE OF CER- TIFIED EHR TECHNOLOGY ASSOCIATED WITH ELIGIBLE HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE IN YEAR, HIGH SCENARIO

Percent asso- Fiscal year ciated with eli- Percent pay- gible hospitals able in year

2011 ...... 43.4 43.4 2012 ...... 58.5 58.5 2013 ...... 73.9 73.9 2014 ...... 84.8 84.8 2015 ...... 93.6 50.2 2016 ...... 97.3 35.1 2017 ...... 99.1 ...... 2018 ...... 100.0 ......

For instance in FY 2012 under the will be paid. In FY 2015 under the high incentive payments, and therefore 50.2 high scenario, 58.5 percent of the total scenario, 93.6 percent of the total percent of all possible incentive amount of incentive payments which amount of incentive payments which payments actually paid in that year. could be payable in that year would be could be payable will be for hospitals Table 44 shows the low scenario for eligible hospitals who have who have certified EHR systems, but estimates. demonstrated meaningful use of some of those eligible hospitals would certified EHR technology and therefore have already received 4 years of

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TABLE 44—ESTIMATED PERCENTAGE OF MEDICARE INCENTIVES WHICH COULD BE PAID FOR THE MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY ASSOCIATED WITH ELIGIBLE HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE IN YEAR, LOW SCENARIO

Percent asso- Fiscal year ciated with eli- Percent pay- gible hospitals able in year

2011 ...... 30.5 30.5 2012 ...... 35.5 35.5 2013 ...... 46.2 46.2 2014 ...... 61.7 61.7 2015 ...... 77.8 47.3 2016 ...... 90.9 42.3 2017 ...... 94.5 ...... 2018 ...... 97.3 ......

The estimated payments to eligible 6. Medicaid Incentive Program Costs through 2016. There are also additional hospitals were calculated based on the hospitals, such as children’s and cancer Under section 4201 of the HITECH hospitals’ qualifying status and hospitals that are only eligible for Act, States can voluntarily participate in individual incentive amounts under the Medicaid incentives. statutory formula. Similarly, the the Medicaid incentive payment EPs may qualify for Medicaid estimated penalties for nonqualifying program and we have based our incentive payments if at least 30 percent hospitals were based on the market Medicaid incentive program costs on all basket reductions and Medicare States participating. Eligible hospitals of their patient volume is from revenues. The estimated savings in and EPs can also qualify for a Medicaid Medicaid. (Separate rules apply for Medicare eligible hospital benefit incentive payment for adopting, pediatricians.) As mentioned above, the expenditures resulting from the use of implementing, or upgrading and up to 5 Medicaid maximum incentive payments hospital certified EHR systems are years of incentive payments for are larger than the corresponding discussed under ‘‘general demonstrating meaningful use certified Medicare payments. Various maximums considerations’’ at the end of this EHR technology. Under Medicaid, EPs are specified for eligible hospital and EP section. We assumed no future growth include physicians and pediatricians, incentive payments. There are no in the total number of hospitals in the dentists, certified nurse-midwives, Medicaid penalties for nonadoption of U.S. because growth in acute care nurse practitioners, and certain EHR systems or for failing to hospitals has been minimal in recent physician assistants. Initial incentive demonstrate meaningful use. The years. payments are available through 2016. Federal costs for Medicaid incentive The Medicaid hospital incentives are payments to providers who can c. Critical Access Hospitals (CAHs) similar to those specified in section demonstrate meaningful use of EHR We estimate that there are 1,302 CAHs 4102 of the HITECH Act for Medicare, technology were estimated similarly to eligible to receive EHR incentives except that they are payable for up to 6 the estimates for Medicare eligible payments, and that will participate in years based on the ratio of Medicaid the incentive program beginning in FY inpatient days to total days, and are not hospital and EP. Table 45 shows our 2011. The statistics for their incentives phased down by the Medicare eligible high estimates for the net Medicaid are incorporated into the overall hospital transition factors. Medicaid costs for eligible hospitals and EP. Medicare and Medicaid program costs. hospitals can begin incentive payments

TABLE 45—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (–) UNDER MEDICAID, HIGH SCENARIO [In $billions]

Incentive payments Benefit Fiscal year Eligible payments Net total Hospitals professionals

2009 ...... 2010 ...... 2011 ...... 1.1 1.2 (1) 2.3 2012 ...... 1.2 0.9 (1) 2.1 2013 ...... 0.7 0.9 (1) 1.6 2014 ...... 0.4 0.9 (1) 1.3 2015 ...... 0.3 0.9 (1) 1.2 2016 ...... 0.2 1.0 (1) 1.2 2017 ...... 0.1 0.4 (1) 0.5 2018 ...... 0.0 0.3 (1) 0.3 2019 ...... 0.0 0.2 (1) 0.2

Total, 2009–2014...... 3.4 3.8 0.0 7.2 Total, 2009–2019 ...... 4.1 6.6 ¥0.1 10.6 1 Savings of less than $50 million.

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Table 46 shows the low estimates for Medicaid costs and savings.

TABLE 46—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (–) UNDER MEDICAID, LOW SCENARIO [In $billions]

Incentive payments Benefit Fiscal year Eligible payments Net total Hospitals professionals

2009 ...... 2010 ...... 2011 ...... 0.7 0.6 (1) 1.3 2012 ...... 0.6 0.4 (1) 1.0 2013 ...... 0.4 0.4 (1) 0.9 2014 ...... 0.5 0.5 (1) 1.0 2015 ...... 0.6 0.5 (1) 1.1 2016 ...... 0.6 0.5 (1) 1.1 2017 ...... 0.3 0.2 (1) 0.5 2018 ...... 0.1 0.2 (1) 0.2 2019 ...... 0.0 0.1 (1) 0.1

Total, 2009–2014...... 2.3 1.9 0.0 4.2 Total, 2009–2019 ...... 3.8 3.5 ¥0.1 7.3 1 Savings of less than $50 million.

a. Medicaid EPs assumed to choose the Medicaid previously there is much uncertainty To determine the Medicaid EP incentive payments, as they are larger. about the rates of demonstration of incentive payments, we first determined In addition, the total number of meaningful that will be achieved. the number of qualifying EPs. As Medicaid EPs was adjusted to include Therefore, as we estimated for the indicated above, we assumed that 20 EPs who qualify for the Medicaid Medicare EPs, we are providing high percent of the non-hospital-based incentive payments but not for the and low scenario estimates for Medicaid Medicare EPs would meet the Medicare incentive payments, such as EPs. requirements for Medicaid incentive most pediatricians, dentists, certified Our high scenario estimates are listed payments (30 percent of patient volume nurse-midwives, nurse practitioners and in the Table 47. from Medicaid). All of these EPs were physicians assistants. As noted BILLING CODE 4120–01–P

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Under the high scenario, we assumed qualify for incentive payments in CY or she is engaged in efforts to adopt, an increase over baseline participation 2011, resulting in a CY 2011 cost of implement, or upgrade certified EHR of Medicaid EPs because of the about $1.2 billion. It should be noted technology, these participation rates incentive payments, with the proportion that since the Medicaid EHR incentive include not only meaningful users but of EPs ever receiving incentive payment program provides that a eligible providers implementing payments increasing from 46.5 percent Medicaid EP can receive an incentive certified EHR technology as well. Table in CY 2011 to 93.7 percent by CY 2019. payment in their first year because he or 48 shows our low scenario estimates. About 55,000 EPs are projected to she is a meaningful user or because he

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BILLING CODE 4120–01–C separately calculated the range of Medicare and Medicaid incentive b. Medicaid Hospitals percentage of total potential incentives payments. that could be associated with qualifying As stated previously, the estimated Medicaid incentive payments to most hospitals, year by year, and the eligible hospital incentive payments acute-care hospitals were estimated corresponding actual percentages were calculated based on the hospitals’ using the same adoption assumptions payable each year. Acute care hospitals qualifying status and individual and methodology as described and children’s hospitals can receive incentive amounts payable under the previously for Medicare eligible Medicaid incentive payments for no less statutory formula. The estimated savings hospitals and shown in Table 49. than 3 years but no more than 6 years in Medicaid benefit expenditures Because hospitals’ Medicare and resulting from the use of certified EHR and may qualify to receive both the Medicaid patient loads differ, we technology are discussed under ‘‘general

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considerations.’’ We estimated the children’s hospitals as an add-on to the of children’s hospitals compared to non- Medicaid incentives payable to base estimate, using data on the number children’s hospitals.

TABLE 49—ESTIMATED PERCENTAGE OF POTENTIAL MEDICAID INCENTIVES ASSOCIATED WITH ELIGIBLE HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE EACH YEAR, HIGH SCENARIO

Percent asso- Fiscal year ciated with eli- Percent pay- gible hospitals able in year

2011 ...... 60.7 60.7 2012 ...... 75.5 75.5 2013 ...... 86.0 86.0 2014 ...... 91.5 30.8 2015 ...... 96.3 20.8 2016 ...... 98.3 12.3 2017 ...... 99.5 6.8 2018 ...... 100.0 2.0 2019 ...... 100.0 0.0

Table 50 shows our low scenario estimates.

TABLE 50—ESTIMATED PERCENTAGE OF POTENTIAL MEDICAID INCENTIVES ASSOCIATED WITH ELIGIBLE HOSPITALS AND ESTIMATED PERCENTAGE PAYABLE EACH YEAR, LOW SCENARIO

Percent asso- Fiscal year ciated with eli- Percent pay- gible hospitals able in year

2011 ...... 35.6 35.6 2012 ...... 40.6 40.6 2013 ...... 50.9 50.9 2014 ...... 66.8 31.2 2015 ...... 81.6 41.0 2016 ...... 92.6 41.7 2017 ...... 95.5 25.8 2018 ...... 97.4 11.0 2019 ...... 100.0 0.0

7. Benefits for All EPs and All Eligible Reductions in medical recordkeeping Some vendors have estimated that Hospitals costs, reductions in repeat tests, EHRs could result in cost savings of decreases in length of stay, and reduced between $100 and $200 per patient per In this proposed rule we have not errors. Furthermore, there is limited but year. As adoption increases, there will quantified the overall benefits to the growing evidence to support the cost be more opportunities to capture and industry, nor to eligible hospitals or EPs saving benefits anticipated from wider report on cost savings and benefits. A in the Medicare, Medicaid, or MA adoption of EHRs. For example, at one number of relevant studies are required programs. We believe that the first 5 hospital emergency room in Delaware, in the HITECH Act for this specific years of the incentive program will be the ability to download and create a file purpose, and the results will be made dedicated to implementation activities, with a patient’s medical history saved public, as they are available. from installation of the technology to the ER $545 per use, mostly on reduced 8. Benefits to Society training to operational and behavioral waiting times. A pilot study of changes. Information on the costs and ambulatory practices found a positive According to the recent CBO study benefits of adopting systems specifically ROI within 16 months and annual ‘‘Evidence on the Costs and Benefits of meeting the requirements in this rule savings thereafter (Greiger et al. 2007, A Health Information Technology’’ (http:// does not yet exist—and information on Pilot Study to Document the Return on www.cbo.gov/ftpdocs/91xx/doc9168/05- costs and benefits overall is limited Investment for Implementing an 20-HealthIT.pdf), when used effectively, (Goldzweig et al. 2009 ‘‘Costs and Ambulatory Electronic Health Record at EHRs can enable providers to deliver Benefits of Health Information an Academic Medical Centers.) Some health care more efficiently. For Technology: New Trends from the vendors have estimated that EHRs could example, they can reduce the Literature’’ Health Affairs.) We would result in cost savings of between $100 duplication of diagnostic tests, prompt welcome industry input on the impact and $200 per patient per year. As providers to prescribe cost-effective of this proposed rule on adoption, the adoption increases, there will be more generic medications, remind patients costs of adopting and meeting the opportunities to capture and report on about preventive care, reduce meaningful use criteria, and on resulting cost savings and benefits. A number of unnecessary office visits and assist in benefits to providers. relevant studies are required in the managing complex care. Further, the Nonetheless, we believe there are HITECH Act for this specific purpose, report points out that there is a potential benefits that can be obtained by eligible and the results will be made public, as to gain both internal and external hospitals and EPs, including: they are available. savings from widespread adoption of

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health IT, noting that internal savings hospital and EP incentives will depend • American Hospital Association. would likely be in the reductions in the in part on the standards developed and • Actuarial Research Corporation. cost of providing care, and that external applied for assessing meaningful use of • RAND Health studies on: savings could accrue to the health certified EHR technology. We will ++ ‘‘The State and Pattern of Health insurance plan or even the patient, such administer the requirements in such a Information Technology Adoption’’ as the ability to exchange information way as to encourage adoption of (Fonkych & Taylor, 2005); more efficiently. The benefits resulting certified EHR technology and facilitate ++ ‘‘Extrapolating Evidence of Health specifically from this proposed qualification for incentive payments, Information Technology Savings and regulation are even harder to quantify and will adopt progressively demanding Costs’’ (Girosi, Meili, & Scoville, 2005); because they represent, in many cases, standards each year. Certified EHR and adding functionality to existing systems technology has the potential to help ++ ‘‘The Diffusion and Value of and reaping the network externalities reduce medical costs through efficiency Healthcare Information Technology’’ created by larger numbers of providers improvements, such as prompter (Bower, 2005). participating in information exchange. treatments, avoidance of duplicate or • Kaiser Permanente (staff and We would welcome additional data on otherwise unnecessary services, and publications). the costs and benefits of specific reduced administrative costs (once • Miscellaneous other sources (Health provisions of this rule and the incentive systems are in place), with most of these Affairs, American Enterprise Institute, program as a whole so that we can savings being realized by the providers news articles and perspectives). conduct, for the final rule, a more robust rather than by Medicare or Medicaid. To As noted at the beginning of this assessment of societal benefits to the extent that this technology will have analysis, it is difficult to predict the determine whether the benefits of the a net positive effect on efficiency, then actual impacts of the HITECH Act with regulation justify its costs (as directed more rapid adoption of such EHR much certainty at this time. We believe by Executive Order 12866). systems would achieve these the assumptions and methods described efficiencies sooner than would 9. General Considerations herein are reasonable for estimating the otherwise occur, without the EHR financial impact of the provisions on the The estimates for the HITECH Act incentives. Medicare and Medicaid programs, but provisions were based on the economic The CBO has estimated a modest level acknowledge the wide range of possible assumptions underlying the President’s of such savings attributable to EHRs, outcomes. We invite comments on all of 2010 Budget. Under the statute, with much of the amount associated our assumptions. Medicare incentive payments for with reductions in adverse drug-to-drug All financial analysis is calculated certified EHR technology are excluded interactions. We believe that most of over a 10-year planning horizon, from the determination of MA such savings will result from the because though the incentive payments capitation benchmarks. As noted existing statutory requirements for e- for Medicare EPs, CAHs and eligible previously, there is considerable prescribing and that the acceleration of hospitals will only be paid for 5 years, uncertainty about the rate at which other efficiency savings will be the Medicaid incentives will cease in eligible hospitals and EPs will adopt relatively modest in comparison to the CY 2021. Starting in CY 2015, payment EHRs and other HIT. Nonetheless, we incentive and payment adjustments. We adjustments will be made to the believe that the Medicare incentive expect a negligible impact on benefit Medicare physician fee schedule. payments and the prospect of significant payments to hospitals and EPs from payment penalties for nonparticipation Medicare and Medicaid as a result of the 10. Summary will result in the great majority of implementation of EHR technology.’’ The total cost to the Medicare and hospitals implementing certified EHR In the process of preparing the Medicaid programs is estimated to be technology in the early years of the estimates for this rule, we consulted range from $14.1 (low scenario) to 27.3 Medicare EHR incentive program. We with and/or relied on internal CMS (high scenario) billion over a 10-year expect that a steadily growing sources, as well as the following timeframe. We do not estimate total proportion of practices will implement sources: costs to the provider industry, but rather certified EHR technology over the next • Congressional Budget Office (staff provide a possible per EP and per 10 years, even in the absence of the and publications). eligible hospital outlay for Medicare incentives. Actual future • American Medical Association implementation and maintenance Medicare and Medicaid costs for eligible (staff and unpublished data). operations.

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Table 53 shows the total costs from after which the payment adjustments 2009 through 2019 for the high scenario will be invoked.

11. Explanation of Benefits and Savings benefits to the Medicare and Medicaid percent and 7 percent factors. Calculations programs. Additional expenditures that will be undertaken by eligible entities in order H. Accounting Statement In our analysis, we assume that to obtain the Medicare and Medicaid benefits to the program would accrue in Whenever a rule is considered a incentive payments to adopt and the form of savings to Medicare, through significant rule under Executive Order demonstrate meaningful use of certified the Medicare EP payment adjustments. 12866, we are required to develop an EHR technology, and to avoid the Expected qualitative benefits, such as Accounting Statement indicating the Medicare payment adjustments that will improved quality of care, better health classification of the expenditures ensue if they fail to do so are noted by outcomes, reduced errors and the like, associated with the provisions of this a placeholder in the accounting unable to be quantified at this time. We proposed rule. Monetary annualized statement. We are not able to explicitly invite public comment on the subject of benefits and non-budgetary costs are define the universe of those additional presented as discounted flows using 3 costs, nor specify what the high or low

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range might be. We invite public to implement EHR technology at the comments that may inform additional final rule stage. analysis on the subject of industry costs

In accordance with the provisions of PART 412—PROSPECTIVE PAYMENT of the Act, that is not a meaningful Executive Order 12866, this proposed SYSTEMS FOR INPATIENT HOSPITAL electronic health record (EHR) user as rule was reviewed by the Office of SERVICES defined in part 495 of this chapter, Management and Budget. three-fourth of the applicable percentage 1. The authority citation for part 412 change specified in paragraph (d)(1) of List of Subjects continues to read as follows: this section is reduced— 42 CFR Part 412 Authority: Secs. 1102 and 1871 of the (i) For fiscal year 2015, by 331⁄3 Administrative practice and Social Security Act (42 U.S.C. 1302 and percent; 1395hh). (ii) For fiscal year 2016, by 662⁄3 procedure, Health facilities, Medicare, percent; and Puerto Rico, Reporting and Subpart D—Basic Methodology for (iii) For fiscal year 2017 and recordkeeping requirements. Determining Prospective Payment subsequent fiscal years, by 100 percent. 42 CFR Part 413 Federal Rates for Inpatient Operating * * * * * Costs Health facilities, Kidney diseases, PART 413—PRINCIPLES OF Medicare, Reporting and recordkeeping 2. Section 412.64 is amended by— REASONABLE COST requirements. A. Revising paragraph (d)(2)(i)(B). REIMBURSEMENT; PAYMENT FOR B. Adding a new paragraphs 42 CFR Part 422 END-STAGE RENAL DISEASE (d)(2)(i)(C) and (d)(3). SERVICES; OPTIONAL Administrative practice and The revision and additions read as PROSPECTIVELY DETERMINED procedure, Health facilities, Health follows: maintenance organizations (HMO), PAYMENT RATES FOR SKILLED Medicare, Penalties, Privacy, Reporting § 412.64 Federal rates for inpatient NURSING FACILITIES and recordkeeping requirements. operating costs for Federal fiscal year 2005 and subsequent fiscal years. 3. The authority citation for part 413 continues to read as follows: 42 CFR Part 495 * * * * * Administrative practice and (d) * * * Authority: Secs. 1102, 1812(d), 1814(b), procedure, Electronic health records, (2) * * * 1815, 1833(a), (i), and (n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Health facilities, Health professions, (i) * * * Act (42 U.S.C. 1302, 1395d(d), 1395f(b), Health maintenance organizations (B) For fiscal year 2007 through 2014, 1395g, 1395l(a), (i), and (n), 1395x(v), (HMO), Medicaid, Medicare, Penalties, by 2 percentage points. 1395hh, 1395rr, 1395tt, and 1395ww); and Privacy, Reporting and recordkeeping (C) For fiscal year 2015 and sec. 124 of Public Law 106–133 (113 Stat. requirements. subsequent fiscal years, by one-fourth. 1501A–332). For the reasons set forth in the * * * * * Subpart E—Payments to Providers preamble, the Centers for Medicare & (3) Beginning in fiscal year 2015, in Medicare Services proposed to amend the case of a ‘‘subsection (d) hospital,’’ 4. Section 413.70 is amended by— 42 CFR Chapter IV as follows: as defined under section 1886(d)(1)(B) A. Revising paragraph (a)(1).

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B. Adding new paragraphs (a)(5) and contractors determine, on an annual § 422.306 Annual MA capitation rates. (a)(6). basis, that requiring the CAH to become * * * * * The revision and additions read as a qualifying CAH under § 495.106 of (b) * * * follows: this chapter would result in a significant (2) * * * hardship, such as in the case of a CAH (iv) Adjusted to exclude costs § 413.70 Payment for services of a CAH. in a rural area without sufficient attributable to payments under sections (a) Payment for inpatient services Internet access. 1848(o) and 1886(n) of the Act of furnished by a CAH (other than services (iii) In no case may a CAH be granted Medicare FFS incentive payments for of distinct part units). (1) Effective for an exemption under this paragraph meaningful use of electronic health cost reporting periods beginning on or (a)(6) for more than 5 years. records. after January 1, 2004, payment for (iv) There is no administrative or * * * * * inpatient services of a CAH, other than judicial review under section 1869 of 8. Section 422.308 is amended by— services of a distinct part unit of the the Act, section 1878 of the Act, or A. Redesignating paragraph (a) as CAH and other than the items included otherwise of the following: paragraph (a)(1). in the incentive payment described in (A) The methodology and standards B. Adding a new paragraph (a)(2). paragraph (a)(5) of this section and for determining the amount of payment The addition reads as follows: subject to the adjustments described in under paragraph (a)(5) of this section. paragraph (a)(6) of this section, is 101 (B) The methodology and standards § 422.308 Adjustments to capitation rates, benchmarks, bids, and payments. percent of the reasonable costs of the for determining the amount of payment CAH in providing CAH services to its adjustments made under this paragraph * * * * * inpatients, as determined in accordance (a)(6). (a) * * * (2) The amount calculated in with section 1861(v)(1)(A)of the Act and (C) The methodology and standards paragraph (a)(1) of this section must the applicable principles of cost for determining a CAH to be a qualifying exclude expenditures attributable to reimbursement in this part and in Part CAH under § 495.106 of this chapter. sections 1848(a)(7) and (o) and sections 415 of this chapter, except that the (D) The methodology and standards 1886(b)(3)(B)(ix) and (n) of the Act. following payment principles are for determining if the hardship excluded when determining payment exemption applies to a CAH under * * * * * for CAH inpatient services: paragraph (a)(6)(ii) of this section. 9. Section 422.322 is amended by— (i) Lesser of cost or charges; (E) The specification of the cost A. Adding paragraph (a)(3). (ii) Ceilings on hospital operating reporting periods, payment years, or B. Revising paragraph (b). fiscal years as applied under this costs; § 422.322 Source of payment and effect of (iii) Reasonable compensation paragraph. MA plan election on payment. equivalent (RCE) limits for physician (F) The calculation of reasonable costs under § 495.106(c) of this chapter. (a) * * * services to providers; and (3) Payments under subpart C of part (iv) The payment window provisions * * * * * 495 of this chapter for meaningful use for preadmission services, specified in of certified EHR technology are made § 412.2(c)(5) of this subchapter and PART 422—MEDICARE ADVANTAGE PROGRAM from the Federal Hospital Insurance § 413.40(c)(2) of this part. Trust Fund or the Supplementary * * * * * 5. The authority citation for part 422 Medical Insurance Trust Fund. In (5) A qualifying CAH receives an continues to read as follows: applying section 1848(o) of the Act incentive payment for the reasonable Authority: Secs. 1102 and 1871 of the under sections 1853(l) and 1886(n)(2) of costs of purchasing certified EHR Social Security Act (42 U.S.C. 1302 and the Act under section 1853(m) of the technology in a cost reporting period 1395hh). Act, CMS determines the amount to the during a payment year as determined extent feasible and practical to be under § 495.106 of this chapter in lieu Subpart G—Payments to Medicare similar to the estimated amount in the of payment for such reasonable costs Advantage Organizations aggregate that would be payable for under paragraph (a)(1) of this section. 6. Section 422.304 is amended by services furnished by professionals and (6)(i) For cost reporting periods adding a new paragraph (f) to read as hospitals under Parts B and A, beginning in or after FY 2015, if a CAH follows: respectively, under title XVIII of the is not a qualifying CAH, as defined in Act. § 495.106(a) of this chapter, then § 422.304 Monthly payments. (b) Payments to the MA organization. notwithstanding the percentage * * * * * Subject to § 412.105(g), § 413.86(d), and applicable in paragraph (a)(1) of this (f) Separate payment for meaningful § 495.204 of this chapter and §§ 422.109, section, the reasonable costs of the CAH use of certified EHRs. In the case of 422.316, and 422.320, CMS’ payments in providing CAH services to its qualifying MA organizations, as defined under a contract with an MA inpatients are adjusted, by the following in § 495.200 of this chapter, entitled to organization (described in § 422.304) applicable percentage: MA EHR incentive payments per with respect to an individual electing an (A) For cost reporting periods § 495.220 of this chapter, such payments MA plan offered by the organization are beginning in FY 2015, 100.66 percent; are made in accordance with sections instead of the amounts which (in the (B) For cost reporting periods 1853(l) and (m) of the Act and subpart absence of the contract) would beginning in FY 2016, 100.33 percent; C of Part 495 of this chapter. otherwise be payable under original and 7. Section 422.306 is amended by: Medicare for items and services (C) For cost reporting periods A. Removing ‘‘and’’ from the end of furnished to the individual. beginning in FY 2017 and each paragraph (b)(2)(ii); * * * * * subsequent fiscal year, 100 percent. B. Removing the period at the end of (ii) A CAH may, on a case-by-case paragraph (b)(2)(iii) and adding ‘‘; and’’ SUBCHAPTER G—STANDARDS AND basis, be exempt from the application of in its place; and CERTIFICATIONS the adjustments made under this C. Adding a new paragraph (b)(2)(iv) 10. A new part 495 is added to read paragraph, if CMS or its Medicare to read as follows: as follows:

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PART 495—STANDARDS FOR THE 495.336 Health information technology (f) Sections 1903(a)(3)(F) and 1903(t) ELECTRONIC HEALTH RECORD planning advance planning document of the Act to provide 100 percent TECHNOLOGY INCENTIVE PROGRAM requirements (HIT PAPD). Federal financial participation (FFP) to 495.338 Health information technology States for incentive payments to certain Subpart A—General Provisions implementation advance planning document requirements (HIT IAPD). eligible providers participating in the Sec. 495.340 As-needed HIT PAPD update and Medicaid program to purchase, 495.2 Basis and purpose. as-needed HIT IAPD update implement, and operate (including 495.4 Definitions. requirements. support services and training for staff) 495.6 Meaningful use objectives measures 495.342 Annual HIT IAPD requirements. certified EHR technology and 90 percent for EPs, eligible hospitals, and CAHs. 495.344 Approval of the State Medicaid FFP for State administrative expenses 495.8 Demonstration of meaningful use HIT plan, the HIT PAPD and update, the criteria related to such incentive payments. HIT IAPD and update, and the annual (g) Sections 1848(a)(7), 1853(l)(4), 495.10 Participation requirements for EPs HIT IAPD. and eligible hospitals, and qualifying 1886(b)(3)(ix)(1), and 1853(m)(4) of the 495.346 Access to systems and records. Act, providing for payment reductions CAHs. 495.348 Procurement standards. 495.350 State Medicaid agency attestations. for inpatient services furnished on or Subpart B—Requirements Specific to the after October 1, 2014 to Medicare Medicare Program 495.352 Reporting requirements. 495.354 Rules for charging equipment. beneficiaries by hospitals that are not 495.100 Definitions. 495.356 Nondiscrimination requirements. meaningful users of certified electronic 495.102 Incentive payments to EPs. 495.358 Cost allocation plans. health record technology, and for 495.104 Incentive payments to eligible 495.360 Software and ownership rights. hospitals. covered professional services furnished 495.362 Retroactive approval of FFP with on or after January 1, 2015 to Medicare 495.106 Incentive payments to CAHs. an effective date of February 18, 2009. 495.108 Posting of required information. beneficiaries by physicians and other 495.364 Review and assessment of professionals who are not meaningful administrative activities and expenses of Subpart C—Requirements Specific to users of certified electronic health Medicare Advantage (MA) Organizations Medicaid provider health information technology adoption and operation. record technology. 495.200 Definitions. 495.366 Financial oversight and monitoring § 495.4 Definitions. 495.202 Identification of qualifying MA of expenditures. organizations, MA–EPs, and MA- 495.368 Combating fraud and abuse. In this part, unless otherwise affiliated eligible hospitals. 495.370 Appeals process for a Medicaid indicated— 495.204 Incentive payments to qualifying provider receiving electronic health Certified electronic health record MA organizations for MA–EPs and record incentive payments. technology means a qualified EHR that hospitals. 495.206 Timeframe for payment to Authority: Secs. 1102 and 1871 of the meets the certification requirements qualifying MA organizations. Social Security Act (42 U.S.C. 1302 and specified in 45 CFR 170.102. 495.208 Avoiding duplicate payment. 1395hh). Critical access hospital (CAH) means 495.210 Meaningful user attestation. a facility that has been certified as a 495.212 Limitation on review. Subpart A—General Provisions critical access hospital under section 1820(e) of the Act and for which Subpart D—Requirements Specific to the § 495.2 Basis and purpose. Medicaid Program Medicare payment is made under This part implements the following: section 1814(l) of the Act for inpatient 495.300 Basis and purpose. (a) Section 1848(o) of the Act by services and under section 1834(g) of 495.302 Definitions. establishing payment incentives under the Act for outpatient services. 495.304 Medicaid provider scope and Medicare Part B for physicians and eligibility. EHR reporting period means either of other professionals who adopt and the following: 495.306 Establishing patient volume. meaningfully use certified electronic 495.308 Net average allowable costs as the (1) For an EP— health record technology. basis for determining the incentive (i) For the first payment year, any payment. (b) Section 1853(1) of the Act to continuous 90-day period within a 495.310 Medicaid provider incentive provide incentive payments to Medicare calendar year; payments. Advantage organizations for their (ii) For the second, third, fourth, fifth 495.312 Process for payments. affiliated professionals who or sixth payment year, the calendar 495.314 Activities required to receive an meaningfully use certified EHR year. incentive payment. technology and meet certain other (2) For an eligible hospital or a CAH— 495.316 State monitoring and reporting requirements. (i) For the first payment year, any regarding activities required to receive (c) Section 1886(n) of the Act by continuous 90-day period within a fiscal an incentive payment. establishing incentives payments for the year; and 495.318 State responsibilities for receiving meaningful use of certified EHR FFP. (ii) For the second, third, fourth, fifth 495.320 FFP for payments to Medicaid technology by subsection (d) hospitals, or sixth payment year, the fiscal year. providers. as defined under section 1886(d)(1)(B) Eligible hospital means an eligible 495.322 FFP for reasonable administrative of the Act, participating in Medicare hospital as defined under § 495.100 or expenses. FFS program. Medicaid eligible hospital under 495.324 Prior approval conditions. (d) Section 1814(l) of the Act to subpart D of this part. 495.326 Disallowance of Federal financial provide an incentive payment to critical Eligible professional (EP) means an participation (FFP). access hospitals who meaningfully use eligible professional as defined under 495.328 Request for reconsideration of certified EHR technology based on the § 495.100 or a Medicaid eligible adverse determination. hospitals’ reasonable costs. professional under subpart D of this 495.330 Termination of Federal financial participation (FFP) for failure to provide (e) Section 1853(m) of the Act to part. access to information. provide incentive payments to MA Fifth payment year means the fifth 495.332 State Medicaid (HIT) plan organizations for certain affiliated payment year that the EP, eligible requirements. hospitals that meaningfully use certified hospital or CAH receives an incentive 495.334 State self-assessment requirements. EHR technology. payment under this part.

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First payment year means the first eligible hospital or CAH receives an following objectives and associated payment year that the EP, eligible incentive payment under this part. measures: hospital or CAH receives an incentive Sixth payment year means the sixth (1)(i) Objective. Implement drug-drug, payment under this part. payment year that the EP, eligible drug-allergy, drug-formulary checks. Fourth payment year means the fourth hospital or CAH receives an incentive (ii) Measure. The EP, eligible hospital payment year that the EP, eligible payment under this part. or CAH has enabled this functionality. hospital or CAH receives an incentive Third payment year means the third (2)(i) Objective. Maintain an up-to- payment under this part. payment year that the EP, eligible date problem list of current and active Hospital-based EP is an EP (as defined hospital or CAH receives an incentive diagnoses based on ICD–9–CM or under this section) who furnishes 90 payment under this part. SNOMED CT ®. percent or more of his or her covered (ii) Measure. At least 80 percent of all professional services in the CY § 495.6 Meaningful use objectives and unique patients seen by the EP or measures for EPs, eligible hospitals, and preceding the payment year in a CAHs. admitted to an eligible hospital or CAH hospital setting. A setting is considered have at least one entry or an indication (a) Stage 1 criteria for EPs—(1) a hospital setting if it is identified by the of none recorded as structured data. General rule regarding Stage 1 criteria codes used in the HIPAA standard (3)(i) Objective. Maintain active for meaningful use for EPs. Except as transactions that identifies the site of medication list. specified in paragraph (a)(2) of this service as an inpatient hospital, (ii) Measure. At least 80 percent of all section, EPs must meet all objectives outpatient hospital, or emergency room. unique patients seen by the EP or Meaningful EHR user means— and associated measures of the Stage 1 admitted by the eligible hospital or CAH (1) An EP, eligible hospital or CAH criteria specified in paragraphs (c) and have at least one entry (or an indication that, for an EHR reporting period for a (d) of this section to receive an incentive of ‘‘none’’ if the patient is not currently payment year, demonstrates in payment. prescribed any medication) recorded as accordance with § 495.8 meaningful use (2) Exceptions for Medicaid EPs—(i) structured data. of certified EHR technology by meeting Exception for Medicaid EPs receiving (4)(i) Objective. Maintain active the applicable objectives and associated payment in CY 2010. If CMS has medication allergy list. measures under § 495.6; and approved a State’s request to begin (ii) Measure. At least 80 percent of all (2) A Medicaid EP or Medicaid providing incentive payments to EPs in unique patients seen by the EP or eligible hospital, that meets paragraph CY 2010 for adopting, implementing or admitted to the eligible hospital or CAH (1) of this definition and any additional upgrading certified EHR technology, the have at least one entry (or an indication criteria for meaningful use imposed by objectives and associated measures of of ‘‘none’’ if the patient has no the State and approved by CMS under the Stage 1 criteria specified in medication allergies) recorded as § 495.316 and § 495.332. paragraphs (c) and (d) are applicable to structured data. Payment year means— an EP whose second payment year is CY (5)(i) Objective. Record the following (1) For an EP other than a Medicaid 2011. demographics: EP, a calendar year beginning with CY (ii) Exception for Medicaid EPs who (A) Preferred language. 2011; and adopt, implement or upgrade in their (B) Insurance type. (2) For a CAH or an eligible hospital first payment year. For Medicaid EPs (C) Gender. other than a Medicaid eligible hospital, who adopt, implement, or upgrade (D) Race. a Federal fiscal year beginning with FY certified EHR technology in their first (E) Ethnicity. 2011. payment year, the meaningful use (F) Date of birth. (3) For a Medicaid EP, objectives and associated measures of (G) For eligible hospitals or CAHs, the (i) The timeframe specified in the Stage 1 criteria specified in date and cause of death in the event of paragraph (1) of this definition; or paragraphs (c) and (d) apply beginning mortality. (ii) In accordance with subpart D of with the second payment year, and do (ii) Measure. At least 80 percent of all this part and with CMS approval, CY not apply to the first payment year. unique patients seen by the EP or 2010. (b) Stage 1 criteria for eligible admitted to the eligible hospital or CAH (4) For a Medicaid eligible hospital, hospitals and CAHs—(1) General rule have the demographics specified in (i) The timeframe specified in regarding Stage 1 criteria for meaningful paragraphs (c)(5)(i)(A) through (G) of paragraph (2) of this definition; or use for eligible hospitals or CAHs. this section recorded as structured data. (ii) In accordance with subpart D of Except as specified in paragraph (b)(2) (6)(i) Objective. (A) Record and chart the part and with CMS approval, of this section, eligible hospitals and changes in the following vital signs: FY2010. CAHs must meet all objectives and (1) Height. Qualified EHR means an electronic associated measures of the Stage 1 (2) Weight. record of health related information on criteria specified in paragraphs (c) and (3) Blood pressure. an individual that includes patient (e) of this section to receive an incentive (B) Calculate and display the body demographic and clinical health payment. mass index (BMI) for patients 2 years information, such as medical history (2) Exception for Medicaid eligible and older. and problem lists; and has the capacity hospitals. For Medicaid eligible (C) Plot and display growth charts for to meet all of the following: hospitals who adopt, implement, or children 2 to 20 years including body (1) Provide clinical decision support. upgrade certified EHR technology in mass index. (2) Support physician order entry. their first payment year, the meaningful (ii) Measure. For at least 80 percent of (3) Capture and query information use objectives and associated measures all unique patients age 2 years or older relevant to health care quality. of the Stage 1 criteria specified in seen by the EP or admitted to the (4) To exchange electronic health paragraphs (c) and (e) apply beginning eligible hospital, record blood pressure information with, and integrate such with the second payment year. and BMI and plot the growth chart for information from other sources. (c) Stage 1 criteria for EPs and eligible children age 2 to 20 years old. Second payment year means the hospitals or CAHs. An EP, eligible (7)(i) Objective. Record smoking status second payment year that the EP, hospital or CAH must satisfy the for patients 13 years old or older.

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(ii) Measure. At least 80 percent of all (16)(i) Objective. Capability to provide (7)(i) Objective. Provide clinical unique patients 13 years old or older electronic syndromic surveillance data summaries to patients for each office seen by the EP or admitted to the to public health agencies and actual visit. eligible hospital or CAH have ‘‘smoking transmission according to applicable (ii) Measure. Clinical summaries status’’ recorded. law and practice. provided to patients for at least 80 (8)(i) Objective. Incorporate clinical (ii) Measure. Performed at least one percent of all office visits. lab-test results into EHR as structured test of certified EHR technology’s (8)(i) Objective. Capability to data. capacity to provide electronic exchange key clinical information (ii) Measure. At least 50 percent of all syndromic surveillance data to public among providers of care and patient clinical lab tests results ordered by the health agencies (unless none of the authorized entities electronically. EP or authorized provider of the public health agencies to which the EP, (ii) Measure. Perform at least one test hospital during the EHR reporting eligible hospital or CAH submits such of certified EHR technology’s capacity to period whose results are either in a information have the capacity to receive electronically exchange key clinical positive/negative or numerical format the information electronically). information. are incorporated in certified EHR (17)(i) Objective. Protect electronic (e) Additional Stage 1 criteria for technology as structured data. health information created or eligible hospitals or CAHs. Eligible (9)(i) Objective. Generate lists of maintained by certified EHR technology hospitals or CAHs must meet the patients by specific conditions to use for through the implementation of following objectives and associated quality improvement, reduction of appropriate technical capabilities. measures: disparities, research and outreach. (ii) Measure. Conduct or review a (1)(i) Objective. Use computerized (ii) Measure. Generate at least one security risk analysis in accordance provider order entry (CPOE) for orders report listing patients of the EP, eligible with the requirements under 45 CFR (any type) directly entered by hospital or CAH with a specific 164.308(a)(1) and implement security authorizing provider (for example, MD, condition. updates as necessary. DO, RN, PA, NP). (10)(i) Objective. Implement five (d) Additional Stage 1 criteria for EPs. (ii) Measure. CPOE is used for at least clinical decision support rules relevant An EP must meet the following 10 percent of all orders. to specialty or high clinical priority, objectives and associated measures: (2)(i) Objective. Report hospital including for diagnostic test ordering, (1)(i) Objective. Use computerized quality measures to CMS or, in the case along with the ability to track provider order entry (CPOE). of Medicaid eligible hospitals, the (ii) Measure. CPOE is used for at least compliance with those rules. States. (ii) Measure. Implement five clinical 80 percent of all orders. (ii) Measure. Successfully report to (2)(i) Objective. Generate and transmit decision support rules relevant to the CMS (or, in the case of Medicaid eligible permissible prescriptions electronically clinical quality metrics reported under hospitals, the States) clinical quality (eRx). measures in the form and manner this subpart. (ii) Measure. At least 75 percent of all (11)(i) Objective. Check insurance specified by CMS. permissible prescriptions written by the (3)(i) Objective. Provide patients with eligibility electronically from public and EP are transmitted electronically using private payers. an electronic copy of their health certified EHR technology. information (including diagnostic test (ii) Measure. Insurance eligibility is (3)(i) Objective. Report ambulatory results, problem list, medication lists, checked electronically for at least 80 quality measures to CMS or, in the case allergies, discharge summary, and percent of all unique patients seen by of Medicaid EPs, the States. the EP or admitted to the eligible (ii) Measure. Successfully report to procedures), upon request. hospital or CAH. CMS (or, in the case of Medicaid EPs, (ii) Measure. At least 80 percent of all (12)(i) Objective. Submit claims the States) clinical quality measures in patient requests for an electronic copy electronically to public and private the form and manner specified by CMS. of their health information are provided payers. (4)(i) Objective. Send reminders to it within 48 hours (ii) Measure. At least 80 percent of all patients per patient preference for (4)(i) Objective. Provide patients with claims filed electronically by the EP or preventive/follow-up care. an electronic copy of their discharge the eligible hospital or CAH. (ii) Measure. Reminder sent to at least instructions and procedures at time of (13)(i) Objective. Perform medication 50 percent of all unique patients seen by discharge, upon request. reconciliation at relevant encounters the EP that are 50 years of age and over. (ii) Measure. At least 80 percent of all and each transition of care. (5)(i) Objective. Provide patients with patients who are discharged from an (ii) Measure. Perform medication an electronic copy of their health eligible hospital or CAH and who reconciliation for at least 80 percent of information (including diagnostic test request an electronic copy of their relevant encounters and transitions of results, problem list, medication lists, discharge instructions and procedures care. and allergies) upon request. are provided it. (14)(i) Objective. Provide summary (ii) Measure. At least 80 percent of all (5)(i) Objective. Capability to care record for each transition of care patient requests for an electronic copy exchange key clinical information (for and referral. of their health information are provided example, discharge summary, (ii) Measure. Provide summary of care it within 48 hours. procedures, problem list, medication record for at least 80 percent of (6)(i) Objective. Provide patients with list, allergies, and diagnostic test results) transitions of care and referrals. timely electronic access to their health among providers of care and patient- (15)(i) Objective: Capability to submit information (including diagnostic test authorized entities electronically. electronic data to immunization results, problem list, medication lists, (ii) Measure. Performed at least one registries and actual submission where and allergies) within 96 hours of the test of certified EHR technology’s required and accepted. information being available to the EP. capacity to electronically exchange key (ii) Measure: Performed at least one (ii) Measure. At least 10 percent of all clinical information. test of certified EHR technology’s unique patients seen by the EP are (6)(i) Objective. Capability to provide capability to submit electronic data to provided timely electronic access to electronic submission of reportable lab immunization registries. their health information. results (as required by State or local

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law) to public health agencies and each of the applicable objectives and eligible hospital or CAH used certified actual submission where it can be associated measures under § 495.6, EHR and specify the technology used. received. except § 495.6(d)(3) ‘‘Report ambulatory (ii) Attest, through a secure (ii) Measure. Performed at least one quality measures to CMS or, in the case mechanism, in a manner specified by test of certified EHR technology capacity of Medicaid EPs, the states.’’ CMS (or for a Medicaid eligible hospital, to provide electronic submission of (iii) For § 495.6(d)(3), ‘‘Report in a manner specified by the State), that reportable lab results to public health ambulatory quality measures to CMS or, during the EHR reporting period, the agencies (unless none of the public in the case of Medicaid EPs, the States’’, eligible hospital or CAH satisfied each health agencies to which the eligible report electronically to CMS (or in the of the applicable objectives and hospital submits such information have case of Medicaid EPs, the States) associated measures under § 495.6 the capacity to receive the information clinical quality information in the form except § 495.6(e)(2). The eligible electronically). and manner specified by CMS. hospital or CAH must specify the EHR (iv) For Medicaid EPs, if, in reporting period and provide the result § 495.8 Demonstration of meaningful use of each applicable measure, except for criteria. accordance with § 495.316 and § 495.332, CMS has approved a State’s § 495.6(e)(2) ‘‘Report hospital quality (a) Demonstration by EPs. An EP must additional criteria for meaningful use, measures to CMS or, in the case of demonstrate that he or she satisfies each demonstrate meeting such criteria using Medicaid eligible hospitals, the States:’’ of the applicable objectives and the method approved by CMS. (iii) For § 495.6(e)(2) ‘‘Report hospital associated measures under § 495.6 of (b) Demonstration by eligible clinical quality measures to CMS or, in this subpart as follows: hospitals and CAHs. To successfully the case of Medicaid eligible hospitals, (1) For CY 2011, demonstrate meaningful use an eligible the States,’’ report electronically to CMS (i) Attest, through a secure (or in the case of Medicaid eligible mechanism, in a manner specified by hospital or CAH must the following requirements: hospitals, the States), clinical quality CMS (or for a Medicaid EP, in a manner measures in the form and manner specified by the State), that during the (1) For FY 2011— (i) Attest, through a secure specified by CMS. EHR reporting period, the EP used (iv) For Medicaid hospitals if, in certified EHR technology, and specify mechanism, in a manner specified by CMS (or for a Medicaid eligible hospital, accordance with § 495.316 and the technology used. § 495.332, CMS has approved a State’s (ii) Attest, through a secure in a manner specified by the State), that during the EHR reporting period, the additional criteria for meaningful use, mechanism, in a manner specified by demonstrate meeting such criteria using CMS (or for a Medicaid EP, in a manner eligible hospital or CAH used certified EHR and specify the technology used. the method approved by CMS. specified by the State), that during the (c) Review of meaningful use. (1) CMS EHR reporting period, the EP satisfied (ii) Attest, through a secure mechanism, in a manner specified by may review an EP, eligible hospital or each of the applicable objectives and CAH’s demonstration of meaningful use. associated measures under § 495.6 of CMS (or for a Medicaid eligible hospital, in a manner specified by the State), that (2) EPs, eligible hospitals, and CAHs this part. The EP must specify the EHR must keep documentation supporting reporting period and provide the result during the EHR reporting period, the eligible hospital or CAH satisfied each their demonstration of meaningful use of each applicable measure for all for 10 years. patients seen during the EHR reporting of the applicable objectives and period for which a selected measure is associated measures under § 495.6. The § 495.10 Participation requirements for applicable. eligible hospital or CAH must specify EPs, eligible hospitals, and CAHs. (iii) For Medicaid EPs, if, in the EHR reporting period and provide (a) An eligible hospital, CAH or EP accordance with § 495.316 and the result of each applicable measure for must submit in a manner specified by § 495.332, CMS has approved a State’s all patients admitted to the eligible CMS the following information in the additional criteria for meaningful use, hospital during the EHR reporting first payment year: demonstrate meeting such criteria using period for which a selected measure is (1) Name of the EP, eligible hospital the method approved by CMS. applicable. or CAH. (iv) Exception for Medicaid EPs. If a (iii) Exception for Medicaid eligible (2) National Provider Identifier (NPI). Medicaid EP has adopted, implemented hospitals. If a Medicaid eligible hospital (3) Business address and phone or upgraded certified EHR technology has adopted, implemented or upgraded number. described in § 495.4 of this subpart, the certified EHR technology for the first (b) In addition to the information provider must demonstrate meaningful payment year, the eligible hospital must submitted under paragraph (a) of this use in the second payment year as demonstrate meaningful use in the section, an eligible hospital or CAH, described in § 495.6 and § 495.8 of this second payment year, see § 495.6 and must, in the first payment year, submit subpart. § 495.8. in a manner specified by CMS its CMS (2) For CY 2012 and subsequent (iv) For hospitals participating in the Certification Number (CCN) and its years— Medicaid EHR incentive program, if, in Taxpayer Identification Number (TIN). (i) Attest, through a secure accordance with § 495.316 and (c) Subject to paragraph (f) of this mechanism, in a manner specified by § 495.332, CMS has approved a State’s section, in addition to the information CMS (or for a Medicaid EP, in a manner additional criteria for meaningful use, submitted under paragraph (a) of this specified by the State) that during the demonstrate meeting such criteria using section, an EP must submit in a manner EHR reporting period, the EP used the method approved by CMS. specified by CMS, the Taxpayer certified EHR technology and specify (2) For FY 2012 and subsequent years Identification Number (TIN) to which the technology used. must— the EP’s incentive payment should be (ii) Attest, through a secure (i) Attest, through a secure made. mechanism, in a manner specified by mechanism, in a manner specified by (d) In the event the information CMS (or for a Medicaid EP, in a manner CMS (or for a Medicaid eligible hospital, specified in paragraphs (a) through (c) of specified by the State), that during the in a manner specified by the State), that this section as previously submitted to EHR reporting period, the EP satisfied during the EHR reporting period, the CMS is no longer accurate, the EP or

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eligible hospital must provide updated of the Act, which includes all of the qualifying eligible professional is 2011 information to CMS or the State on a following types of professionals: or 2012, $18,000). timely basis in the manner specified by (1) A doctor of medicine or (ii) For the second payment year, CMS or the State. osteopathy. $12,000. (e) An EP that qualifies as both a (2) A doctor of dental surgery or (iii) For the third payment year, Medicaid EP and Medicare EP— medicine. $8,000. (1) Must notify CMS in the manner (3) A doctor of podiatric medicine. (iv) For the fourth payment year, specified by CMS as to whether he or (4) A doctor of optometry. $4,000. she elects to participate in the Medicare (5) A chiropractor. (v) For the fifth payment year, $2,000. or the Medicaid EHR incentive program. Geographic health professional (vi) For any succeeding payment year (2) Is limited to switching between shortage area (HPSA) means an area for such professional, $0. programs one time, and only for that is designated by the Secretary (2)(i) If the first payment year for a payment years 2014 and before; under section 332(a)(1)(A) of the PHS qualifying eligible professional is 2014, (3) Must, for each payment year, meet Act as of December 31 of the year prior then the amount for a payment year for all of the Medicare or Medicaid to the payment year as having a shortage a qualifying EP is the same as the applicable requirements, including of health professionals. amount specified for such payment year applicable patient volume requirements, Qualifying CAH means a CAH that is for a qualifying EP whose first payment for the program he or she chooses to a meaningful EHR user for the EHR year is 2013. participate in; reporting period for a cost reporting (ii) If the first payment year for a (4) Is limited to receiving, in total, the period beginning during a payment qualifying EP is after 2014, then the maximum payments the EP would year. applicable amount specified in this receive under the Medicaid EHR Qualifying eligible professional (EP) paragraph for such professional for such program, as described in subpart D of means an EP who is a meaningful EHR year and any subsequent year must be this part; user for the EHR reporting period for a $0. (5) Is placed in the payment year the payment year and who is not a hospital- (c) Increase in incentive payment EP would have been in, had the EP not based EP. limit for EPs who predominantly furnish switched programs. For example, an EP Qualifying hospital means an eligible services in a geographic HPSA. In the that begins receiving Medicaid incentive hospital that is a meaningful EHR user case of a qualifying eligible professional payments in 2011, and then switches to for the EHR reporting period for a who in the year prior to the payment the Medicare program for 2012, is in his payment year. year furnishes more than 50 percent of or her second payment year in 2012. his or her covered professional services (f) Limitations on incentive payment § 495.102 Incentive payments to EPs. in a geographic HPSA, the annual reassignments. Section 1842(b)(6)(A) of (a) General rules. (1) Subject to incentive payment limit determined the Act allows for the reassignment of paragraph (b) of this section, in addition under paragraph (b) of this section is to payments under Medicare to an to the amount otherwise paid under be increased by 10 percent. employer or entity with which the EP section 1848 of the Act, there shall be (d) Payment adjustment effective in has a contractual arrangement allowing paid to a qualifying eligible professional CY 2015 and subsequent years for the employer or entity to bill and (or to an employer or entity in the cases nonqualifying EPs. receive payment for the EP’s covered described in section 1842(b)(6)(A) of the (1) Subject to paragraph (d)(3) of this professional services. Act) for a payment year an amount section, beginning in 2015, for covered (1) EPs are permitted to reassign their equal 75 percent of the estimated professional services furnished by an EP incentive payments to their employer or allowed charges under the physician fee who is not a qualifying EP or a hospital- to an entity with which they have a schedule (established under section based EP for the year, the payment contractual arrangement, consistent 1848 of the Act) for the covered amount for such services is equal the with all rules governing reassignments professional services furnished by the product of the applicable percent including part 424, subpart F of this EP during the payment year. specified in paragraph (d)(2) and the chapter. (2) For purposes of this paragraph (a), Medicare physician fee schedule (2) Each EP may only reassign the the estimated allowed charges for the amount for such services. entire amount of the incentive payment qualifying EP’s covered professional (2) Applicable percent. Applicable to one employer or entity. services during the payment year are percent is as follows: Subpart B—Requirements Specific to determined based on claims submitted (i) For 2015, 99 percent if the eligible the Medicare Program no later than 2 months after the end of professional is not subject to the the payment year, and, in the case of a payment adjustment for an eligible § 495.100 Definitions. qualifying EP who furnishes covered professional who is not a successful In this subpart unless otherwise professional services in more than one electronic prescriber under section indicated— practice, are determined based on 1848(a)(5) of the Act, or 98 percent if the Covered professional services means claims submitted for the EP’s covered eligible professional is subject to the services furnished by an eligible professional services across all such payment adjustment for an eligible professional for which payment is made practices. professional who is not a successful under, or is based on, the Medicare (b) Limitations on amounts of electronic prescriber under section physician fee schedule as provided in incentive payments. 1848(a)(5) of the Act). section 1848(k)(3) of the Act. (1) Except as otherwise provided in (ii) For 2016, 98 percent. Eligible hospital means a hospital paragraph (b)(2) and paragraph (c) of (iii) For 2017 and each subsequent subject to the prospective payment this section, the amount of the incentive year, 97 percent. system specified in § 412.1(a)(1) of this payment that a qualifying EP can (3) Significant hardship exception. chapter, excluding those hospitals receive for each payment year is limited The Secretary may, on a case-by-case specified in § 412.23 of this chapter. to the following amounts: basis, exempt an EP who is not a Eligible professional (EP) means a (i) For the first payment year, $15,000 qualifying EP from the application of physician as defined in section 1861(r) (or, if the first payment year for such the payment adjustment under

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paragraph (d)(1) of this section, if the (3) Initial amount. The initial amount (B) 3⁄4 for FY 2014; Secretary determines that compliance is equal to one of the following: (C) 1⁄2 for FY 2015; and with the requirement for being a (i) For each hospital with 1,149 (D) 1⁄4 for FY 2016. meaningful EHR user would result in a discharges or fewer during the fiscal (iv) Hospitals whose first payment significant hardship for the EP. The year prior to the payment year, year is FY 2014— Secretary’s determination to grant an EP $2,000,000. (A) 3⁄4 for FY 2014; an exemption under this paragraph (ii) For each hospital with at least (B) 1⁄2 for FY 2015; and (d)(3) may be renewed on an annual 1,150 but no more 23,000 discharges (C) 1⁄4 for FY 2016. basis, provided that in no case may an during the payment year, $2,000,000 + (v) Hospitals whose first payment year EP be granted an exemption under this [$200 × (n ¥ 1,149)], where n is the is FY 2015— paragraph (d)(3) for more than 5 years. number of discharges for the hospital (A) 1⁄2 for FY 2015; and during the fiscal year prior to the (B) 1⁄4 for FY 2016. § 495.104 Incentive payments to eligible hospitals. payment year. § 495.106 Incentive payments to CAHs. (iii) For each hospital with more than (a) General rule. A qualifying hospital 23,000 discharges for the fiscal year (a) Definitions. In this section, unless (as defined in this subpart) shall receive prior to the payment year, $6,370,400. otherwise indicated— the special incentive payment as (4) Medicare share fraction— (i) Payment year means a Federal fiscal determined under the formulas General. (A) CMS determines the year beginning after FY 2010 but before described in paragraph (c) of this Medicare share fraction by using the FY 2016. Qualifying CAH means a CAH that section for the period specified in number of Medicare Part A, Medicare would meet the definition of a paragraph (b) of this section. Part C, and total inpatient-bed-days (b) Transition periods. Subject to the meaningful EHR user at § 495.4, if it using data from the Medicare cost report payment formula specified in paragraph were an eligible hospital. as specified by CMS. (e) of this section, qualifying hospitals (B) CMS computes the denominator of Reasonable costs incurred for the may receive incentive payments during the Medicare share fraction using the purchase of certified EHR technology for transition periods which comprise the charity care charges reported on the a qualifying CAH means the reasonable following fiscal years: acquisition costs incurred for the (1) Hospitals whose first payment year hospital’s Medicare cost report. (ii) The Medicare share fraction is the purchase of depreciable assets as is FY 2011 may receive such payments described in part 413 subpart G of this for FYs 2011 through 2014. ratio of— (A) A numerator which is the sum chapter, such as computers and (2) Hospitals whose first payment year associated hardware and software, is FY 2012 may receive such payments of— (1) The number of inpatient-bed-days necessary to administer certified EHR for FYs 2012 through 2015. technology as defined in § 495.4, (3) Hospitals whose first payment year during the period which are attributable to individuals with respect to whom excluding any depreciation and interest is FY 2013 may receive such payments expenses associated with the for FYs 2013 through 2016. payment may be made under Part A; and acquisition. (4) Hospitals whose first payment year (b) General rule. A qualifying CAH is FY 2014 may receive such payments (2) The number of inpatient-bed-days during the period which are attributable receives an incentive payment for its for FY 2014 through 2016. reasonable costs incurred for the (5) Hospitals whose first payment year to individuals who are enrolled with a purchase of certified EHR technology, as is FY 2015 may receive such payments Medicare Advantage organization (as defined in paragraph (a) of this section, for FY 2015 through 2017. defined in § 422.2 of this chapter). (c) Payment methodology. (1) The (iii) A denominator which is the in the manner described in paragraph incentive payment for each payment product of— (c) of this section for a cost reporting year is calculated as the product of the (A) The total number of inpatient-bed- period beginning during a payment year following: days during the period; and as defined in paragraph (a) of this (i) The initial amount determined (B) The total amount of the eligible section. under paragraph (c)(3) of this section; hospital’s charges during the period, not (c) Payment methodology— (1) (ii) The Medicare share fraction including any charges that are Payment amount. A qualifying CAH determined under paragraph (c)(4) of attributable to charity care divided by receives an incentive payment amount this section; and the estimated total amount of the equal to the product of its reasonable (iii) The transition factor determined hospitals charges during the period. costs incurred for the purchase of under paragraph (c)(5) of this section. (5) Transition factor. For purposes of certified EHR technology and the (2) Interim and final payments. CMS the payment formula, the transition Medicare share percentage. uses data on hospital discharges (as that factor is as follows: (2) Calculation of reasonable costs. term is defined in § 412.4(a) of this (i) For hospitals whose first payment CMS or its Medicare contractor chapter), Medicare Part A inpatient-bed- year is FY 2011— computes a qualifying CAH’s reasonable days, Medicare Part C inpatient-bed- (A) 1 for FY 2011; costs incurred for the purchase of days, and total inpatient-bed-days, from (B) 3⁄4 for FY 2012; certified EHR technology, as defined in the hospital cost report for the hospital (C) 1⁄2 for FY 2013; and paragraph (a) of this section, as the sum fiscal year that ends during the Federal (D) 1⁄4 for FY 2014. of— fiscal year prior to the fiscal year that (ii) Hospitals whose first payment (i) The reasonable costs incurred for serves as the payment year as the basis year is FY 2012— the purchase of certified EHR for making preliminary incentive (A) 1 for FY 2012; technology during the cost reporting payments. Final payments are (B) 3⁄4 for FY 2013; period that begins in a payment year; determined at the time of settling the (C) 1⁄2 for FY 2014; and and hospital cost report for the hospital (D) 1⁄4 for FY 2015; (ii) Any reasonable costs incurred for fiscal year that ends during the payment (iii) Hospitals whose first payment the purchase of certified EHR year, and settled on the basis of data year is FY 2013— technology in cost reporting periods from that cost reporting period. (A) 1 for FY 2013; beginning in years prior to the payment

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year which have not been fully this chapter unless otherwise exempt an incentive payment is made for depreciated as of the cost reporting from such adjustment. qualifying MA-affiliated eligible period beginning in the payment year. (f) Administrative or judicial review. hospitals under this subsection to a (3) Medicare share percentage. There is no administrative or judicial qualifying MA organization. Notwithstanding the percentage review under sections 1869 or 1878 of Inpatient-bed-days is defined in the applicable under § 413.70(a)(1) of this the Act, or otherwise, of the — same manner and is used in the same chapter, the Medicare share percentage (1) Methodology and standards for manner as that term is defined and used equals the lesser of— determining the amount of payment, the for purposes of implementing section (i) 100 percent; or reasonable cost, and adjustments 4201(a) of the American Recovery and (ii) The sum of the Medicare share described in this section including Reinvestment Act of 2009 with respect fraction for the CAH as calculated under selection of periods for determining, to the Medicare FFS hospital EHR § 495.104(c)(3) of this subpart and 20 and making estimates or using proxies incentive program in § 495.104 of this percentage points. of, inpatient-bed-days, hospital charges, part. (d) Incentive payments made to charity charges, and the Medicare share Patient care services means health CAHs. (1) The amount of the incentive percentage as described in this section; care services for which payment would payment made to a qualifying CAH (2) Methodology and standards for be made under, or for which payment under this section represents the determining if a CAH is a qualified CAH would be based on, the fee schedule expensing and payment of the under this section; established under Medicare Part B if reasonable costs computed in paragraph (3) Specification of EHR reporting they were furnished by an EP. (c) of this section in a single payment periods, cost reporting periods, payment Payment year means – year and, as specified in § 413.70(a)(5) years, and fiscal years used to compute (1) For a qualifying MA EP, a calendar of this chapter, such payment is made the CAH incentive payment as specified year beginning with CY 2011 and in lieu of payment that would have been in this section; and ending with CY 2016; and (4) Identification of the reasonable made under § 413.70(a)(1) of this (2) For an eligible hospital, a Federal costs used to compute the CAH chapter for the reasonable costs of the fiscal year beginning with FY 2011 and incentive payment under paragraph (c) purchase of certified EHR technology ending with FY 2016. of this section including any Qualifying MA-affiliated eligible including depreciation and interest reconciliation of the CAH incentive hospital means an eligible hospital expenses associated with the payment amount made under paragraph under section 1886(n)(6) of the Act that acquisition. (d) of this section. is under common corporate governance (2) The amount of the incentive with a qualifying MA organization and payment made to a qualifying CAH § 495.108 Posting of required information. that of the Medicare beneficiaries it under this section is paid through a (a) CMS posts, on its Internet Web serves, more than two-thirds are prompt interim payment for the site, the following information regarding Medicare individuals enrolled under applicable payment year after— EPs, eligible hospitals, and CAHs MA plans, and that is a meaningful user (i) The CAH submits the necessary receiving an incentive payment under of certified EHR technology as defined documentation, as specified by CMS or subparts B and C of this part: by § 495.4 of this part. In the case of a its Medicare contractors, to support the (1) Name. hospital for which at least one-third of computation of the incentive payment (2) Business addresses. whose Medicare bed-days for the year amount under this section; and (3) Business phone number. are covered under Part A rather than (ii) CMS or its Medicare contractor (b) CMS posts, on its Internet Web Part C, payment for that payment year reviews such documentation and site, the following information for is only be made under section 1886(n) determines the interim amount of the qualifying MA organizations that receive an incentive payment under of the Act and not under this section. incentive payment. Qualifying MA EP means all of the (3) The interim incentive payment subpart C of this part— (1) The information specified in following: made under this paragraph is subject to (1) A physician (as described in paragraph (a) of this section for each of a reconciliation process as specified by section 1861(r) of the Act), including a the qualifying MA organization’s MA CMS and the final incentive payment as doctor of medicine or osteopathy who is determined by CMS or its Medicare plan information; and (2) The information specified in either of the following: contractor is considered payment in full (i) Employed by a qualifying MA for the reasonable costs incurred for the paragraph (a) of this section for each of the qualifying MA organization’s MA organization. purchase of certified EHR technology in (ii) Employed by, or is a partner of, an EPs and MA-affiliated eligible hospitals. a single payment year. entity that through a contract with a (4) In no case may an incentive Subpart C—Requirements Specific to qualifying MA organization furnishes at payment be made with respect to a cost Medicare Advantage (MA) least 80 percent of the entity’s Medicare reporting period beginning during a Organizations patient care services to enrollees of such payment year before FY 2011 or after FY organization. 2015 and in no case may a CAH receive § 495.200 Definitions. (2) Furnishes at least 80 percent of his an incentive payment under this section As used in this subpart: or her professional services covered with respect to more than 4 consecutive First payment year means with under Title XVIII to enrollees of the payment years. respect to— qualifying MA organization. (e) Reductions in payment to CAHs. (1) Covered professional services (3) Furnishes, on average, at least 20 For cost reporting periods beginning in furnished by a qualifying MA EP, the hours per week of patient care services FY 2015, if a CAH is not a qualifying first calendar year for which an to enrollees of the qualifying MA CAH for a payment year, then the incentive payment is made for such organization during the EHR reporting payment for inpatient services furnished services under this subsection to a period. by a CAH under § 413.70(a) of this qualifying MA organization. (4) Is a meaningful user of certified chapter is adjusted by the applicable (2) Qualifying MA-affiliated eligible EHR technology in accordance with percentage described in § 413.70(a)(6) of hospitals, the first fiscal year for which § 495.4 of this part.

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Qualifying MA organization means a qualifying MA EPs or potentially (b) Amount payable to qualifying MA MA organization that is organized as a qualifying MA-affiliated eligible organization for qualifying MA EPs. health maintenance organization (HMO) hospitals under the MA EHR incentive (1) CMS substitutes an amount as defined in section 2791(b)(3) of the program must identify themselves to determined to be equivalent to the Public Health Service (PHS) Act which CMS in a form and manner specified by amount computed under § 495.102 of includes a federally qualified HMO, an CMS, as part of submissions of initial this part. organization recognized as an HMO bids under section 1854(a)(1)(A) of the (2) The qualifying MA organization under State law, or a similar Act. must report to CMS within 30 days of organization regulated for solvency (b) Identification of qualifying MA EPs the close of the calendar year, the under State law in the same manner and and qualifying MA-affiliated eligible aggregate annual amount of revenue to the same extent as an HMO. hospitals. attributable to providing services that Second, third, fourth, and fifth (1) A qualifying MA organization, as would otherwise be covered as payment year means with respect to part of its initial bid starting with plan professional services under Part B incentive payments for qualifying— year 2011, must make a preliminary received by each qualifying MA EP for (1) MA EPs to a qualifying MA identification of potentially qualifying enrollees in MA plans of the MA organization, each successive calendar MA EPs and potentially qualifying MA- organization in the payment year. year immediately following the first affiliated eligible hospitals for which the (3) CMS calculates the incentive payment year for the qualifying MA organization is seeking incentive amount for the MA organization for organization. The first payment year and payments. each qualifying MA EP as an amount each successive year immediately (2) A qualifying MA organization equal to 75 percent of the reported following the first payment year, for the must provide CMS with the following annual revenue specified in paragraph qualifying MA organizations, through for each MA EP or eligible hospital: (b)(2) of this section, up to the 2016, is the same for all qualifying MA (i) The MA EP’s or MA-affiliated maximum amounts specified under EPs with respect to any specific eligible hospital’s name. 1848 (o)(1)(B) of the Act. (ii) The address of the MA EP’s qualifying MA organization. (4) For qualifying MA EPs who are (2) MA-affiliated eligible hospitals to practice or MA-affiliated eligible compensated on a salaried basis, CMS a qualifying MA organization, each hospital’s location. requires the qualifying MA organization (iii) NPI. to develop a methodology for estimating successive fiscal year immediately (iv) An attestation by MA organization following the first payment year for the the portion of each qualifying MA EP’s specifying that the MA EP or MA- salary attributable to providing services qualifying MA organization. affiliated eligible hospital meets the Under common corporate governance that would otherwise be covered as eligibility criteria. means that a qualifying MA professional services under Part B to (3) Final identification of potentially MA plan enrollees of the MA organization and a qualifying MA- qualifying MA EP or MA-affiliated affiliated eligible hospital have a organization in the payment year. The eligible hospital must be made by the methodology— common parent corporation, that one is end of the payment year as defined in a subsidiary of the other, or that the (i) Must be approved by CMS; and § 495.200 for which MA EHR incentive (ii) May include an additional amount organization and the hospital have a payments are being sought. common board of directors. related to overhead, where appropriate, (4) Beginning plan year 2015 and for estimated to account for the MA- § 495.202 Identification of qualifying MA subsequent plan years, all qualifying enrollee related Part B practice costs of organizations, MA–EPs and MA-affiliated MA organizations, as part of their initial the salaried qualifying MA EP. eligible hospitals. bids in June for the following plan year (5) For qualifying MA EPs who are not (a) Identification of qualifying MA must— salaried, qualifying MA organizations organizations. (1) Beginning with bids (i) Identify potentially qualifying MA must obtain attestations from such due in June 2010 (for plan year 2011), EPs and potentially qualifying MA- qualifying MA EPs as to the amount of MA organizations seeking affiliated eligible hospitals; compensation received by such EPs for reimbursement for qualifying MA EPs (ii) Include information specified in MA plan enrollees of the MA and qualifying MA-affiliated eligible paragraph (b)(2)(i)(A) through (C) of this organization. The organizations must hospitals under the MA EHR incentive section for each professional and submit to CMS compensation program are required to identify hospital. information for each such MA EP based (iii) Include an attestation that each themselves to CMS in a form and on such attestations. professional and hospital either meets manner specified by CMS, as part of (c) Amount payable to qualifying MA or does not meet the EHR incentive submissions of initial bids under section organization for qualifying MA- payment eligibility criteria. 1854(a)(1)(A) of the Act. affiliated eligible hospitals. (2) Qualifying MA organizations § 495.204 Incentive payments to qualifying (1) CMS substitutes an amount offering MA HMO plans, absent MA organizations for MA–EPs and determined to be equivalent to the evidence to the contrary, are deemed to hospitals. amount computed under § 495.104, to meet the definition of HMO in 42 U.S.C. (a) General rule. A qualifying MA the extent data are not available to 300gg–91(b)(3)–section 2791(b)(3) of the organization receives an incentive compute payments for qualifying MA- PHS Act. payment for its qualifying MA–EPs and affiliated eligible hospitals under the (3) Qualifying MA organizations its qualifying MA-eligible hospitals. The Medicare FFS EHR hospital incentive offering MA plan types other than incentive payment amount paid to a program. CMS uses the same HMOs, must attest to the fact that they qualifying MA organization for a— methodology and defines ‘‘inpatient- meet the definition of HMO in 42 U.S.C. (1) Qualifying MA–EP is the amount bed-days’’ and other terms as used under 300gg–91(b)(3)–section 2791(b)(3) of the determined under paragraph (b) of this the Medicare FFS EHR hospital PHS Act. section; and incentive program in § 495.104 of this (4) Beginning with bids due in June (2) Qualifying MA-eligible hospital is part in computing amounts due 2014 (for plan year 2015), all MA the amount determined under paragraph qualifying MA organizations for MA- organizations with potentially (c) of this section. affiliated eligible hospitals.

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(2) To the extent data are available, EHR incentive program, payment is for determining qualifying MA EPs and qualifying MA organizations must made under the MA EHR incentive the methodology and standards for receive hospital incentive payments program, following the same timeline in determining a meaningful EHR user, through their affiliated hospitals under § 495.104 of this part. including the means of demonstrating the Medicare FFS EHR hospital meaningful use and the selection of incentive program, rather than through § 495.208 Avoiding duplicate payment. measures. the MA EHR hospital incentive (a) Unless a qualifying MA EP is (b) There is no administrative or program. entitled to a maximum payment for a judicial review under sections 1869 or (d) Payment to qualifying MA year under the Medicare FFS EHR 1878 of the Act, or otherwise, of the organizations. CMS makes payment to incentive program, payment for such an methodology and standards for qualifying MA organizations for individual is only be made under the determining payment amounts and qualifying MA EPs only under the MA MA EHR incentive program to a payment adjustments under the MA EHR incentive program and not under qualifying MA organization. EHR hospital incentive program. This the Medicare FFS EHR incentive (b) Payment to qualifying MA includes provisions related to program to the extent an EP has earned organizations for a qualifying MA- duplication of payment avoidance. It less than the maximum incentive affiliated eligible hospital under also includes the methodology and payment for the same period under the common governance only occurs under standards developed for determining Medicare FFS EHR incentive program. the MA EHR incentive program to the qualifying MA-affiliated eligible (e) Payment review under MA. To extent that sufficient data does not exist hospitals and the methodology and ensure the accuracy of the incentive to pay such hospital under the Medicare standards for determining a meaningful payments, CMS conducts selected FFS hospital incentive program under EHR user, including the means of compliance reviews of qualifying MA § 495.104 of this part. In no event are demonstrating meaningful use and the organizations to ensure that EPs and EHR incentive payments made for a selection of measures. eligible hospitals for which such hospital for a payment year under this qualifying organizations received section to the extent they have been Subpart D—Requirements Specific to incentive payments were meaningful made for the same hospital for the same the Medicaid Program users of certified EHR technology in payment year under § 495.104 of this § 495.300 Basis and purpose. accordance with § 422.504 of this part. chapter. (c) Each qualifying MA organization This subpart implements section 4201 (1) The reviews include validation of must ensure that all potentially of the American Reinvestment and the status of the organization as a qualifying MA EPs are enumerated Recovery Act of 2009 and sections qualifying MA organization, verification through the NPI system and that other 1903(a)(3)(F) and 1903(t) of the Act of meaningful use and review of data identifying information required under which authorizes States, at their option, used to calculate incentive payments. § 495.210(b) is provided to CMS. to provide for incentive payments to (2) MA organizations are required to Medicaid providers for adopting, maintain evidence of their qualification § 495.210 Meaningful user attestation. implementing, or upgrading certified to receive incentive payments and the (a) Qualifying MA organizations are electronic health record technology or data necessary to accurately calculate required to attest, in a form and manner for meaningful use of such technology. incentive payments. specified by CMS, that each qualifying This subpart also provides enhanced (3) Documents and records must be MA EP and qualifying MA-affiliated Federal financial participation (FFP) to maintained for 10 years from the date eligible hospitals is a meaningful EHR States to administer these incentive such payments are made with respect to user. payments. a given payment year. (b) Qualifying MA organizations are § 495.302 Definitions. (4) Payments that result from required to attest within 30 days after incorrect or fraudulent attestations, cost the close of a calendar year whether As used in this subpart— data, or any other submission required each qualifying MA EP is a meaningful Acceptance documents mean written to establish eligibility or to qualify for EHR user. evidence of satisfactory completion of such payment, will be recouped by CMS (c) Qualifying MA organizations are an approved phase of work or contract from the MA organization. required to attest within 30 days after and acceptance thereof by the State close of the FY whether each qualifying agency. § 495.206 Timeframe for payment to MA-affiliated eligible hospital is a Acquisition means to acquire health qualifying MA organizations. meaningful user. information technology (HIT) (a) CMS makes payment to qualifying equipment or services for the purpose of MA organizations for qualifying MA EPs § 495.212 Limitation on review. implementation and administration under the MA EHR incentive program (a) There is no administrative or under this Part from commercial sources after computing incentive payments due judicial review under section 1869 or or from State or local government under the Medicare FFS EHR incentive 1878 of the Act, or otherwise of the resources. program according to § 495.102. methodology and standards for Acute care hospital means a health (b) Payments to qualifying MA determining payment amounts and care facility— organizations for qualifying MA- payment adjustments under the MA (1) Where the average length of affiliated eligible hospitals under EHR EP incentive program. This patient stay is 25 days or fewer; and common corporate governance are made includes provisions related to (2) With a CMS certification number under the Medicare FFS EHR incentive duplication of payment avoidance and (previously known as the Medicare program, following the timeline in rules developed related to the fixed provider number) that has the last four specified in § 495.104 of this part. To schedule for application of limitation on digits in the series 0001—0879 the extent sufficient data do not exist to incentive payments for all qualifying Adopt, implement or upgrade pay qualifying MA-affiliated eligible MA EPs related to a specific qualifying means— hospitals under common corporate MA organization. It also includes the (1) Install or commence utilization of governance under the Medicare FFS methodology and standards developed certified EHR technology capable of

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meeting meaningful use requirements; Medicaid management information goals and objectives, measure its current or system (MMIS) means a mechanized business processes and capabilities (2) Expand the available functionality claims processing and information against the (MITA) business capabilities of certified EHR technology capable of retrieval system—referred to as and ultimately develops target meeting meaningful use requirements at Medicaid Management Information capabilities to transform its Medicaid the practice site, including staffing, Systems (MMIS)—that meets specified enterprise to be consistent with the maintenance, and training. requirements and that the Department MITA principles. Children’s hospital means a has found (among other things) is compatible with the claims processing § 495.304 Medicaid provider scope and separately certified children’s hospital, eligibility. either freestanding or hospital-within- and information retrieval systems used hospital that— in the administration of the Medicare (a) General rule. The following (1) Has a CMS certification number, program. The objectives of the MMIS are Medicaid providers are eligible to (previously known as the Medicare to include claims processing and participate in the HIT incentives provider number), that has the last 4 retrieval of utilization and management program: digits in the series 3300–3399; and information necessary for program (1) Medicaid EPs. (2) Predominantly treats individuals administration and audit and must (2) Acute care hospitals. under 21 years of age. coordinate with other mechanized (3) Children’s hospitals. Entities promoting the adoption of systems and subsystems that perform (b) Medicaid EP. The Medicaid certified electronic health record other functions, such as eligibility professional eligible for a EHR incentive technology means the State-designated determination. payment is limited to the following: entities that are promoting the adoption Needy individuals mean individuals (1) A physician. of certified EHR technology by enabling that meet one of following: (2) A dentist. oversight of the business, operational (1) Received medical assistance from Medicaid or the Children’s Health (3) A certified nurse-midwife. and legal issues involved in the (4) A nurse practitioner. adoption and implementation of EHR or Insurance Program. (2) Were furnished uncompensated (5) A physician assistant practicing in by enabling the exchange and use of a Federally Qualified Health Center or electronic clinical and administrative care by the provider. (3) Were furnished services at either Rural Health Clinic, which is so led by data between participating providers, in no cost or reduced cost based on a a physician assistant. a secure manner, including maintaining sliding scale determined by the (c) Additional requirements for the the physical and organizational individuals’ ability to pay. Medicaid EP. To qualify for an EHR relationship integral to the adoption of Patient volume means the minimum incentive payment, a Medicaid EP must certified EHR technology by EPs. participation threshold where the not be hospital-based as defined § 495.4 Health information technology numerator is the total number of of this subpart and meet one of the planning advance planning document Medicaid patients or needy individuals following criteria for each year for (HIT PAPD) means a plan of action that treated in any 90-day period in the most which the EP seeks an EHR incentive requests FFP and approval to recent calendar year preceding the payment: accomplish the planning necessary for a reporting and the denominator is all State agency to determine the need for (1) Have a minimum 30 percent patient encounters in the same 90-day and plan the acquisition of HIT patient volume attributable to period. Represented as follows: individuals receiving Medicaid. equipment or services or both and to [Total (Medicaid) treated in any 90- acquire information necessary to (2) Have a minimum 20 percent day period in the most recent calendar patient volume attributable to prepare a HIT implementation advanced year preceding the reporting/Total planning document or request for individuals receiving Medicaid, and be patients in same 90-day period] * 100; a pediatrician. proposal to implement the State or Medicaid HIT plan. (3) Practice predominantly in a FQHC [Total (Needy Individuals) treated in or RHC and have a minimum 30 percent HIT implementation advance any 90-day period in the most recent planning document (HIT IAPD) means a patient volume attributable to needy calendar year preceding the reporting/ individuals, as defined at § 495.302. plan of action that requests FFP and Total patients in same 90-day period] * (d) Exception. The hospital-based approval to acquire and implement the 100. proposed State Medicaid HIT plan Practices predominantly means an EP exclusion in paragraph (c) does not services or equipment or both. for whom the clinical location for over apply to the Medicaid-EP qualifying Medicaid information technology 50 percent of his or her total patient based on practicing predominantly at a architecture (MITA) is both an initiative encounters over a period of 6 months in FQHC or RHC. and a framework. It is a national the most recent calendar year occurs at (e) Additional requirement for the framework to support improved systems a federally qualified health center or eligible hospital. To be eligible for an development and health care rural health clinic. EHR incentive payment for each year for management for the Medicaid Service oriented architecture or which the eligible hospital seeks an enterprise. It is an initiative to establish service component based architecture EHR incentive payment the eligible national guidelines for technologies and means organizing and developing hospital must meet the following processes that enable improved program information technology capabilities as criteria: administration for the Medicaid collaborating services that interact with (1) An acute care hospital must have enterprise. The MITA initiative includes each other based on open standards. at least a 10 percent Medicaid patient an architecture framework, models, State Medicaid health information volume for each year for which the processes, and planning guidelines for technology plan (SMHP) means a hospital seeks an EHR incentive enabling State Medicaid enterprises to document that describes the State’s payment. meet common objectives with the current and future HIT activities. (2) A children’s hospital is exempt framework while supporting unique State self-assessment means a process from meeting a patient volume local needs. that a State uses to review its strategic threshold.

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§ 495.306 Establishing patient volume. § 495.308 Net average allowable costs as payment program election once, (a) A Medicaid provider must the basis for determining the incentive consistent with § 495.10 of this part but annually meet one of the following to payment. such change in election must occur for establish patient volume: (a) The first year of payment. (1) The payments by occurring before CY 2015. (1)(i) General rule for a professional. incentive is intended to offset the costs (e) General rule for Medicaid EPs and Except as specified in paragraph associated with the initial adoption of hospitals. An Medicaid EP or hospital (a)(1)(ii) of this section, a Medicaid EP certified electronic health records may receive an incentive payment from must attest that a minimum of 30 technology. only one State in a payment year. percent of his or her patient encounters (2) The maximum net average (f) Incentive payments to hospitals. over any continuous 90-day period in allowable costs for the first year are Incentive payments to an eligible the most recent calendar year was $25,000. hospital under this subpart are subject covered by Medicaid. (b) Subsequent payment years. (1) The to all of the following conditions: (ii) Optional exception. (A) A incentive is intended to offset (1) The payment is provided over a pediatrician must attest that a minimum maintenance and operation of certified minimum of a 3-year period and of 20 percent of his or her patient EHR technology. maximum of a 6-year period. (2) The maximum net average encounters over any continuous 90-day (2) The total incentive payment allowable costs for each subsequent year period in the most recent calendar year received over all payment years of the are $10,000. was covered by Medicaid. program is not greater than the aggregate (B) A Medicaid EP practicing § 495.310 Medicaid provider incentive EHR incentive amount, as calculated predominantly in a Federally Qualified payments. under paragraph (g) of this section. Health Center or Rural Health Clinic (a) General rule for a Medicaid EP. (3) No single incentive payment for a must attest that a minimum of 30 The Medicaid EP’s incentive payments payment year may exceed 50 percent of percent of his or her patient encounters are subject to the following limitations: the aggregate EHR hospital incentive over any continuous 90-day period in (1) First payment year. A first year amount calculated under paragraph (g) the most recent calendar year was with payment may not exceed 85 percent of of this section for an individual needy individuals as defined in the maximum threshold of $25,000, hospital. § 495.302 of this subpart. which equals $21,250. (4) No incentive payments over a 2- (2) General rule for an acute care (2) Subsequent annual payment years. year period may exceed 90 percent of hospital. An acute care hospital must A subsequent annual payment may not the aggregate EHR hospital incentive attest that a minimum of 10 percent of exceed 85 percent of the maximum amount calculated under paragraph (g) all patient encounters over any threshold of $10,000, which equals of this section for an individual continuous 90-day period in the most $8,500. hospital. recent calendar year was covered by (i) Payments after the first year may (5) No hospital may begin receiving Medicaid. continue for a maximum of 5 years. (b) If a State has an alternative incentive payments for any year after (ii) Medicaid EPs may participate for 2016. approach to the established timeframe a total of 6 years and may not begin for measuring patient volume, the State (6) A multi-site hospital with one receiving payments any later than CY CMS Certification Number is considered must submit the approach to CMS for 2016. review and prior approval. CMS one hospital for purposes of calculating (3) Maximum incentives. In no case payment. determines if it is an acceptable will the maximum incentive over a 6- alternative. (g) Calculation of the aggregate EHR year period exceed $63,750. hospital incentive amount. The (1) To be considered for approval, the (4) Limitation. For a Medicaid EP who aggregate EHR hospital incentive alternative approach must be justified is a pediatrician described in paragraph amount is calculated as the product of and have a verifiable data source. (b) of this section is as follows: the (overall EHR amount) times (the (2) If CMS approves the State’s (i) The maximum payment in the first Medicaid Share). alternative approach to the established year is further reduced to two-thirds, timeframe for measuring patient which equals $14,167. (1) Overall EHR amount. The overall volume, such timeframe would apply to (ii) The maximum payment in EHR amount for an eligible hospital is Medicaid EPs and eligible hospitals, subsequent years is further reduced to based upon a theoretical 4 years of instead of the 90-day timeframe two-thirds, which equals $5,667. payment the hospital would receive described in paragraph (a) of this (iii) In no case will the maximum based, for each of such 4 years, upon the section. incentive payment to a pediatrician product of the following: (c) To establish patient volume for an under this limitation exceed $42,500 (i) Initial amount. The initial amount EP who practices predominantly in a over a 6-year period. is equal to the sum of— Federally Qualified Health Center or (b) Optional exception for (A) The base amount which is set at Rural Health Clinic by use of pediatricians. A pediatrician described $2,000,000 for each of the theoretical 4 uncompensated care data, an in this paragraph is a Medicaid EP who years; plus adjustment to the uncompensated care does not meet the 30 percent patient (B) The discharge related amount for data must be completed so that it is an volume requirements described in a 12-month period selected by the State appropriate proxy for charity care, § 495.304 and § 495.306, but who meets but with the Federal fiscal year before including a downward adjustment to the 20 percent patient volume the hospital’s fiscal year that serves as eliminate bad debt data from requirements described in such the payment year. The discharge related uncompensated care. sections. amount is the sum of the following, (d) An individual enrolled in a (c) General rule for EPs. An EP may with discharges over the 12-month managed care organization, pre-paid only receive an incentive payment from period and based upon the total inpatient health plan, or pre-paid either Medicare or Medicaid but not discharges for the eligible hospital ambulatory health plan under part 438 both. (regardless of any source of payment): of this chapter must be included in the (d) Optional exception for EPs. An EP (1) For the first through 1,149th calculation to establish patient volume. may change his or her EHR incentive discharge, $0.

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(2) For the 1,150th through the eligible hospital’s data are not available this subpart and approves, processes, 23,000th discharge, $200. on charity care necessary to calculate and makes timely payments using a (3) For any discharge greater than the the portion of the formula specified in process approved by CMS. 23,000th, $0. paragraph (g)(2)(ii)(B) of this section, the (d) State disbursement. The State (C) For purposes of calculating the State may use that provider’s data on disburses an incentive payment to the discharge-related amount under uncompensated care to determine an provider based on the criteria described paragraph (g)(1)(i)(B) of this section, for appropriate proxy for charity care, but in subpart A and this subpart. the last 3 of the theoretical 4 years of must include a downward adjustment to (e) Timeframes. Payments are payment, discharges are assumed to eliminate bad debt from uncompensated disbursed consistent with the following increase by the provider’s average care data. The State must use auditable timeframes for each type of Medicaid annual rate of growth for the most data sources. eligible provider: recent 3 years for which data are (i) Deeming. In the absence of the data (1) Medicaid EPs. States disburse available per year. Negative rates of necessary, with respect to an eligible payments consistent with the calendar growth must be applied as such. hospital the amount described in year on a rolling basis following the end (ii) Medicare share. The Medicare paragraph (g)(2)(ii)(B) must be deemed of the EHR reporting period for the share, which equals 1. to be 1. In the absence of data, with payment year. (iii) Transition factor. The transition respect to an eligible hospital, necessary (2) Medicaid eligible hospitals. States factor which equals as follows: to compute the amount described in disburse payments consistent with the (A) For the first of the theoretical 4 paragraph (g)(2)(i)(B) of this section, the Federal fiscal year on a rolling basis years, 1. amount under such clause must be following the end of the EHR reporting (B) For the second of the theoretical deemed to be 0. period for the payment year. 3 4 years, ⁄4. (j) Dual eligibility for incentives § 495.314 Activities required to receive an (C) For the third of the theoretical 4 payments. A hospital may receive incentive payment. years, 1⁄2. incentive payments from both Medicare (D) For the fourth of the theoretical 4 (a) First payment year. (1) In the first and Medicaid if it meets all eligibility payment year, to receive an incentive years, 1⁄4. criteria. payment, the Medicaid EP or eligible (2) Medicaid share. The Medicaid (k) Payments to State-designated share specified under this paragraph for hospital must meet one of the following: entities. Payments to entities promoting (i) Demonstrate that during the EHR an eligible hospital is equal to a the adoption of certified EHR reporting period for a payment year, it fraction— technology as designated by the State (i) The numerator of which is the sum has adopted, implemented, or upgraded must meet the following requirements: certified EHR technology, as defined in (for the 12 month period selected by the (1) A Medicaid EP may designate his State and with respect to the eligible § 495.302; or or her incentive payment to an entity (ii) Demonstrate that during the EHR hospital) of— promoting the adoption of certified EHR (A) The estimated number of reporting period for a payment year, it technology, as defined in § 495.302, and is a meaningful EHR user as defined in inpatient-bed-days which are as designated by the State, only under attributable to Medicaid individuals; § 495.4. the following conditions: (2) A provider may notify the State of and (i) The State has established a method its non-binding intention to participate (B) The estimated number of to designate entities promoting the in the incentives program prior to inpatient-bed-days which are adoption of EHR technology that having fulfilled all of the eligibility attributable to individuals who are comports with the Federal definition in criteria. enrolled in a managed care organization, § 495.302. (b) Subsequent payment years. (1) In a pre-paid inpatient health plan, or a (ii) The State publishes and makes the second, third, fourth, fifth, and sixth pre-paid ambulatory health plan under available to all EPs a voluntary payment years, to receive an incentive part 438 of this chapter; and mechanism for designating annual payment, the Medicaid EP or eligible (ii) The denominator of which is the payments and includes information hospital must demonstrate that during product of— about the verification mechanism the the EHR reporting period for the (A) The estimated total number of State will use to ensure that the applicable payment year, it is a inpatient-bed-days with respect to the assignment is voluntary and that no meaningful EHR user, as defined in eligible hospital during such period; more than 5 percent of the annual § 495.4. and payment is retained by the entity for (2) The automated reporting of the (B) The estimated total amount of the costs not related to certified EHR clinical quality measures will be eligible hospital’s charges during such technology. accomplished using certified EHR period, not including any charges that (2) [Reserved] technology interoperable with the are attributable to charity care, divided system designated by the State to by the estimated total amount of the § 495.312 Process for payments. receive the data. hospital’s charges during such period. (a) General rule. States must have a (iii) In computing inpatient-bed-days process for making payments consistent § 495.316 State monitoring and reporting under the previous sentence, a State with the requirements in subparts A and regarding activities required to receive an may not include estimated inpatient- D of this part. incentive payment. bed-days attributable to individuals (b) Reporting data consistent with this (a) Subject to § 495.332 the State is with respect to whom payment may be subpart. In order to receive a payment responsible for tracking and verifying made under Medicare Part A, or under this part, a provider must report the activities necessary for a Medicaid inpatient-bed-days attributable to the required data under subpart A and EP or eligible hospital to receive an individuals who are enrolled with a this subpart within the EHR reporting incentive payment for each payment Medicare Advantage organization under period described in § 495.4. year, as described in § 495.314. Medicare Part C. (c) State role. The State determines (b) Subject to § 495.332, the State (h) Approximate proxy for charity the provider’s eligibility for the EHR must submit a State Medicaid HIT Plan care. If the State determines that an incentive payment under subpart A and to CMS that includes:

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(1) A detailed plan for monitoring, technology to promote health care this subpart if the total State and verifying and periodic auditing of the quality and the exchange of health care Federal acquisition cost is more than requirements for receiving incentive information, subject to applicable laws $100,000. payments, as described in § 495.314; and regulations governing such and exchange. § 495.326 Disallowance of Federal financial participation (FFP). (2) A description of the how the State will collect and report on provider § 495.320 FFP for payments to Medicaid If the Department finds that any providers. meaningful use of certified EHR acquisition approved or modified under technology. Subject to the requirements outlined the provisions of this subpart fails to (c) Subject to § 495.332 and § 495.350, in this Subpart, FFP is available at 100 comply with the criteria, requirements, the State is required to submit to CMS percent of State expenditures for and other undertakings described in the annual reports on the following: payments to Medicaid eligible providers approved HIT planning advance (1) Provider adoption, to encourage the adoption and planning document and HIT implementation, or upgrade of certified meaningful use of certified EHR implementation advance planning EHR technology activities and technology. document to the detriment of the proper and efficient operation of the Medicaid payments; and § 495.322 FFP for reasonable (2) Aggregated, de-identified administrative expenses. program, payment of FFP may be meaningful use data. disallowed. In the case of a suspension (d)(1) The annual report described in Subject to prior approval conditions of approval of a HIT planning advance paragraph (c) of this section must at § 495.324 of this subpart, FFP is planning document and HIT include, but is not limited to the available at 90 percent in State implementation advance planning following: expenditures for administrative document, see 45 CFR 205.37(c) and (i) The number, type, and practice activities in support of implementing 307.40(a). location(s) of providers who qualified incentive payments to Medicaid eligible providers. § 495.328 Request for reconsideration of for an incentive payment on the basis of adverse determination. having adopted, implemented, or § 495.324 Prior approval conditions. If CMS disapproves a State request for upgraded certified EHR technology; (a) A State must obtain prior written (ii) Aggregated data tables any elements of a State’s advance approval as specified in paragraph (b) of planning document or State Medicaid representing the provider adoption, this section, when the State plans to implementation, and upgrade of HIT Plan under this subpart, or initiate planning and implementation determines that requirements are met certified EHR technology; activities in support of Medicaid (iii) The number, type, and practice for approval on a date later than the date provider incentive payments location(s) of providers who qualified requested, the decision notice includes encouraging the adoption and use of for an incentive payment on the basis of the following: certified EHR technology with proposed meaningful use of certified EHR (a) The finding of fact upon which the Federal financial participation. technology; determination was made. (b) To receive 90 percent match, each (iv) Aggregated data tables (b) The procedures for appeal of the State must receive prior approval for all representing the provider’s clinical determination in the form of a request of the following: quality measures data; and for reconsideration. (1) The HIT planning advance (v) A description and quantitative planning document and the § 495.330 Termination of Federal financial data on how its incentive payment implementation advance planning participation (FFP) for failure to provide program addressed individuals with document. access to information. unique needs such as children. (2) A request for proposal and any (2) The State may propose additional, (a) The Department terminates FFP at contract that a State may utilize to not substitute, measures for meaningful any time if the Medicaid agency fails to complete activities under this subpart, use of certified EHR technology, subject provide State and Federal unless specifically exempted by the to CMS prior approval. representatives with full access to (e) State failure to submit the required Department, prior to release of the records relating to HIT planning and reports to CMS may result in request for proposal or prior to implementation efforts, and the systems discontinued or disallowed funding. execution of a contract. used to interoperate with electronic (3) For contract amendments, unless HIT, including on-site inspection. § 495.318 State responsibilities for specifically exempted by the (b) The Department may request such receiving FFP. Department, before execution of the access at any time to determine whether In order to be provided FFP under contract amendment, involving contract the conditions in this subpart are being section 1903(a)(3)(F) of the Act, a State cost increases exceeding $100,000 or met. must demonstrate to the satisfaction of contract time extensions of more than the Department, that the State is— 60 days. § 495.332 State Medicaid (HIT) plan (a) Using the funds provided for the (c) Failure to submit any of the requirements. purposes of administering incentive information specified in paragraph (b) of Each State Medicaid HIT plan must payments to providers under this this section to the satisfaction of the include all of the following elements: program, including tracking of Department may result in disapproval or (a) State systems. For State systems, meaningful use by Medicaid providers suspension of project funding. interoperability, and the current and of EHR technology; (d) A State must obtain prior written future visions: (b) Conducting adequate oversight of approval from the Department of its (1) A baseline assessment of the the program, including routine tracking justification for a sole source current HIT landscape environment in of meaningful use attestations and acquisition, when it plans to acquire the State including the inventory of reporting mechanisms; and non-competitively from a existing HIT in the State. The (c) Pursuing initiatives to encourage nongovernmental source HIT equipment assessment must include a the adoption of certified EHR or services, with proposed FFP under comprehensive—

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(i) Description of the HIT ‘‘as-is’’ methodology for verifying such (5) To ensure that a hospital eligible landscape; information. for incentive payments has (ii) Description of the HIT ‘‘to-be’’ (9) A description of the process in demonstrated an average length of stay landscape; and place for ensuring that any certified of 25 days or less and that a (iii) HIT roadmap and strategic plan EHR technology used as the basis for a methodology for verifying such for the next 5 years. payment incentive to Medicaid information is available. (2) A description of how the State providers is compatible with State or (c) Monitoring and validation. For Medicaid HIT plan will be planned, Federal administrative management monitoring and validation of designed, developed and implemented, systems, including the MMIS or other information, States must include the including how it will be implemented automated claims processing system or following: in accordance with the Medicaid information retrieval system and a (1) A description of the process in Information Technology Architecture methodology for verifying such place for ensuring that, because of CMS’ (MITA) principles as described in the information. and the States’ oversight Medicaid Information Technology (10) A description of how each State responsibilities, all provider Framework 2.0. The MITA initiative— will adopt national data standards for information for attestations and any (i) Establishes national guidelines for health and data exchange and open information added to the CMS Single technologies and processes that enable standards for technical solutions as they Provider Repository including all improved program administration for become available. information related to patient volume, the Medicaid enterprise; (11) A description of how the State NPI, Tax identification number (TIN), (ii) Includes business, information intends to address the needs of meaningful use, efforts to adopt, and technology architectures that underserved and vulnerable populations implement, or upgrade are all true and provide an overall framework for such as children, individuals with accurate and that any concealment or interoperability, as well as processes chronic conditions, Title IV–E foster falsification of a material fact related to and planning guidelines for enabling care children, individuals in long-term the attestation may result in prosecution State Medicaid enterprises to meet care settings and the aged, blind, and under Federal and State laws and a common objectives within the disabled. This description must address methodology in place used to verify framework while supporting unique the following: such information. local needs; and (i) Person centered goals and (2) A description of the process in (iii) Is important to the design and objectives and shared decision-making. place for ensuring that the EP or eligible development of State EHR incentive (ii) Coordination of care across hospital is eligible to receive an payment systems. multiple service providers, funding incentive payment consistent with the (3) A description of how intrastate sources, settings, and patient criteria outlined in § 495.314 and a systems, including the Medicaid conditions. methodology in place used to verify Management Information System (iii) Universal design to ensure access such information. (MMIS) and other automated by people with disabilities and older (3) A description of the process in mechanized claims processing and Americans. place for capturing attestations from information retrieval systems— (i) Have been considered in (iv) Self-direction including budget each EP or eligible hospital that they developing a HIT solution; and development and expenditure tracking. have meaningfully used certified EHR (ii) A plan that incorporates the (v) Institutional discharge planning technology during the reporting period, design, development, and and diversion activities that are tied to and that they have adopted, implementation phases for community based service availability. implemented, or upgraded certified EHR interoperability of such State systems (b) Eligibility. For eligibility, a technology during the reporting period with a description of how any planned description of the process in place for and a description of the methodology in systems enhancements support overall all of the following: place used to verify such information. State and Medicaid goals. (1) For ensuring that each EP and (4) A description of the process in (4) A description of data-sharing eligible hospital meets all provider place for capturing clinical quality data components of HIT solutions. enrollment eligibility criteria upon from each EP or eligible hospital and a (5) A description of how each State enrollment and re-enrollment to the description of the methodology in place will promote secure data exchange, Medicaid EHR payment incentive used to verify such information. where permissible under the Health program. (5) A description of the process in Insurance Portability and (2) For ensuring patient volume place for monitoring the compliance of Accountability Act (HIPAA). HIPAA consistent with the criteria in § 495.304 providers coming onto the program with and other requirements included in the and § 495.306 for each EP who practices different requirements depending upon Recovery Act. predominantly in a FQHC or RHC and the year and a methodology for verifying (6) A description of how each State for each Medicaid EP who is a such information. will promote the use of data and physician, pediatrician, nurse (6) A list of the specific actions technical standards to enhance data practitioner, certified nurse midwife or planned to implement the HIT EHR consistency and data sharing through dentist and a methodology in place used incentive program, including a common data-access mechanisms. to verify such information. description and organizational charts for (7) A description of how each State (3) For ensuring that the EP is a workgroups within State government will support integration of clinical and provider who meets patient volume including external partners. administrative data. consistent with the criteria in § 495.304 (7) A description of the process in (8) A description of the process in and a methodology in place used to place to ensure that no amounts higher place for ensuring improvements in verify such information. than 100 percent of FFP will be claimed health outcomes, clinical quality, or (4) For ensuring that each Medicaid for reimbursement of expenditures for efficiency resulting from the adoption of EP is not hospital-based and a State payments to Medicaid eligible certified EHR technology by recipients methodology in place used to verify providers for the certified EHR of Medicaid incentive payments and a such information. technology incentive payment program

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and a methodology for verifying such EPs and a methodology for verifying such information, to address Federal information is available. such information. laws and regulations designed to (8) A description of the process in (2) The process in place to ensure that prevent fraud, waste, and abuse, place to ensure that no amounts higher any existing fiscal relationships with including, but not limited to applicable than 90 percent of FFP will be claimed providers to disburse the incentive provisions of Federal criminal law, the for administrative expenses in payments through Medicaid managed False Claims Act (32 U.S.C. 3729 et administering the certified EHR care plans does not result in payments seq.), and the anti-kickback statute technology incentive payment program that exceed 105 percent of the capitation (section 1128B(b) of the Act). and a methodology for verifying such rate, in order to comply with the (f) Optional—proposed alternatives. A information is available. Medicaid managed care incentive State may choose to propose any of the (9) A description of the process and payment rules at § 438.6(v)(5)(iii) of this following, but they must be included as methodology for ensuring and verifying chapter and a methodology for verifying an element in the State Medicaid HIT such information that includes the such information. Plan for review and approval: following: (3) The process in place to ensure that (1) An alternative methodology for (i) Amounts received under section only appropriate funding sources are measuring patient volume, consistent 1903(a)(3)(F) of the Act with respect to used to make Medicaid EHR incentive with § 495.306(b). payments to a Medicaid EP or eligible payments and that a methodology for (2) (i) Additional requirements for hospital are paid directly to such verifying such information is available. qualifying a Medicaid provider as a provider (or to an employer or facility (4) The process in place to ensure that meaningful user of certified EHR to which such provider has assigned Medicaid EHR incentive payments are technology consistent with § 495.4 and payments) without any deduction or made for no more than 6 years and that § 495.316(e) of this part. rebate. no EP or eligible hospital begins (ii) A State may propose additional (ii) All assignments to an entity receiving payments after 2016 and that meaningful use objectives beyond the promoting the adoption of certified EHR a methodology for verifying such Federal standards at § 495.6, if they do technology, as designated by the State, information is available. not require additional functionality are voluntary for the Medicaid EP (5) The process in place to ensure that beyond that of certified electronic involved. Medicaid EHR incentive payments are health record technology. See also (iii) Entities promoting the adoption not paid at amounts higher than 85 § 495.316(e). of certified EHR technology do not percent of the net average allowable cost (3) A plan for early implementation of retain more than 5 percent of such of certified EHR technology and the incentive payments for a provider who payments for costs not related to yearly maximum allowable payment adopts, implements, or upgrades certified EHR technology (and support thresholds and a methodology for certified EHR technology consistent services including maintenance and verifying such information is available. with the § 495.302 and § 495.314. training) that is for, or is necessary for (6) The process in place to ensure that (i) An approvable plan must include the operation of, such technology. all hospital calculations and hospital mechanisms for making timely and (10) A description of the process in payment incentives are made consistent accurate payments. place for ensuring that each Medicaid with the requirements of this part and (ii) A State will require a provider to EP or eligible hospital that collects an a methodology for verifying such attest that they are not receiving a EHR payment incentive has collected a information is available. payment in any other State. payment incentive from only one State (7) The process in place to provide for even if the provider is licensed to the timely and accurate payment of § 495.334 State self-assessment practice in multiple States and a incentive payments to EPs and eligible requirements. methodology for verifying such hospitals, including the time frame Each State must prepare a State self- information. specified by the State to meet the timely assessment that meets the following (11)(i) A description of the process in payment requirement. requirements: place for ensuring that each EEP or (8) The process in place and a (a) List and prioritize the State’s goals eligible hospital that wishes to methodology for verifying such and objectives for HIT. participate in the EHR incentive information to provide that any monies (b) Define the State’s current business payment program will receive a NPI; that have been paid inappropriately as model and map to the Medicaid and an improper payment or otherwise not information technology architecture (ii) A description of how the NPI will in compliance with this subpart will be business process model. be used to coordinate with the CMS so recouped and FFP will be repaid. (c) Assess the State’s current that the EP will choose only one (e) For combating fraud and abuse capabilities. program from which to receive the and for provider appeals. (1) A (d) Determine the State’s target incentive payment and the hospital description of the process in place for a capabilities. payments are tracked accordingly. provider to appeal consistent with the (12) A description of the process in criteria described in § 495.370 and a § 495.336 Health information technology place for ensuring that each EP or methodology for verifying the following planning advance planning document eligible hospital who wishes to related to the EHR incentives payment requirements (HIT PAPD). participate in the EHR incentive program: Each State’s HIT PAPD must contain payment program will provide a TIN to (i) Incentive payments. the following: the State for purposes of the incentive (ii) Provider eligibility (a) A statement of need and objective payment. determinations. which clearly state the purpose and (d) Payments. Payments must provide (iii) Demonstration of efforts to adopt, objectives of the project to be descriptions of the following processes implement or upgrade and meaningful accomplished and the necessity for the that are in place: use eligibility for incentive payments project. (1) The process in place for ensuring under this part. (b) A project management plan which that there is no duplication of Medicare (2) A description of the process in addresses the following: and Medicaid incentive payments to place, and a methodology for verifying (1) The planning project organization.

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(2) Planning activities and (8) Travel. major project tasks and milestones, deliverables. (9) Administrative operations. addressing the degree of completion and (3) State and contractor resource (10) Miscellaneous expenses for the tasks/milestones remaining to be needs. project. completed and discusses past and (4) Planning project procurement (h) An estimate of prospective cost anticipated problems or delays in activities and schedule. distribution to the various State and meeting target dates in the approved (c) A specific budget for the planning Federal funding sources and the HIT technology PAPD/IAPD and of the project. proposed procedures for distributing approved changes to it. (d) An estimated total project cost and costs. (c) A report of all project deliverables a prospective State and Federal cost (i) A detailed payment listing file completed in the past year and degree distribution, including planning and that— of completion for unfinished products. implementation. (1) Is in an electronic format that may (d) A project activity schedule for the (e) A commitment to submit a HIT be a field delimited ASCII text file, a remainder of the project. implementation advance planning commonly used spreadsheet file, or a (e) A project expenditure status which document. commonly used database file; and consists of a detailed accounting of all (f) A commitment to conduct and (2) Shows each EP and eligible expenditures for project development complete activities which will result in hospital for which the State will provide over the past year and an explanation of the production of the State Medicaid for the payment of incentive payments, the differences between projected HIT plan that includes conduct of the including the— expenses in the approved HIT PAPD/ following activities: (i) Name of the provider; IAPD and actual expenditures for the (ii) National provider identifier of the (1) A statewide HIT environmental past year. provider; baseline self-assessment. (f) A report of any approved or (iii) Type of provider as specified in (2) An assessment of desired HIT anticipated changes to the allocation future environment. § 495.304; (iv) Planned annual payment basis in the advance planning (3) Development of benchmarks and document’s approved cost methodology. transition strategies to move from the amounts; (v) Total of planned payment (g) An updated detailed payment current environment to the desired amounts; and listing file in an electronic format. future environment. (vi) Calendar year of each planned (g) A commitment to submit the plan § 495.344 Approval of the State Medicaid annual payment amount. to CMS for approval. HIT plan, the HIT PAPD and update, the HIT (j) A statement setting forth the IAPD and update, and the annual HIT IAPD. § 495.338 Health information technology security and interface requirements to The Department does not approve any implementation advance planning be employed for all State HIT systems, of these documents that do not include document requirements (HIT IAPD). and related systems, and the system all information required under this Each State’s HIT IAPD must contain failure and disaster recovery procedures subpart. the following: available. § 495.346 Access to systems and records. (a) The results of the activities § 495.340 As-needed HIT PAPD update and conducted as a result of the HIT as-needed HIT IAPD update requirements. The State agency must allow the planning advance planning document, Department access to all records and Each State must submit a HIT PAPD including the approved state Medicaid systems operated by the State in support update or a HIT IAPD no later than 60 HIT plan. of this program, including cost records days after the occurrence of project (b) A statement of needs and associated with approved administrative changes including but not limited to any objectives. funding and incentive payments to of the following: (c) A statement of alternative (a) A projected cost increase of Medicaid providers. State records considerations. $100,000 or more. related to contractors employed for the (d) A personnel resource statement (b) A schedule extension of more than purpose of assisting with indicating availability of qualified and 60 days for major milestones. implementation or oversight activities adequate staff, including a project (c) A significant change in planning or providing assistance, at such director to accomplish the project approach or implementation approach, intervals as are deemed necessary by the objectives. or scope of activities beyond that Department to determine whether the (e) A detailed description of the approved in the HIT planning advance conditions for approval are being met nature and scope of the activities to be planning document or the HIT and to determine the efficiency, undertaken and the methods to be used implementation advance planning economy, and effectiveness of the to accomplish the project. document. program. (f) The proposed activity schedule for (d) A change in implementation § 495.348 Procurement standards. the project. concept or a change to the scope of the (g) A proposed budget including a project. (a) General rule. Procurements of HIT consideration of all HIT implementation (e) A change to the approved cost equipment and services are subject to advance planning document activity allocation methodology. the following procurement standards in costs, including but not limited to the paragraphs (b) through (f) of this section following: § 495.342 Annual HIT IAPD requirements. regardless of any conditions for prior (1) The cost to implement and Each State’s annual HIT IAPD is due approval. These standards— administer incentive payments. 60 days from the HIT IAPD approved (1) Include a requirement for (2) Procurement or acquisition. anniversary date and must contain the maximum practical open and free (3) State personnel. following: competition regardless of whether the (4) Contractor services. (a) A reference to the approved HIT procurement is formally advertised or (5) Hardware, software, and licensing. PAPD/IAPD and all approved changes. negotiated. (6) Equipment and supplies. (b) A project activity status which (2) Are established to ensure that such (7) Training and outreach. reports the status of the past year’s materials and services are obtained in a

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cost effective manner and in compliance (2) In order to ensure objective Grantees of Departmental awards must with the provisions of applicable contractor performance and eliminate take all of the following steps to further Federal statutes and executive orders. unfair competitive advantage, this goal: (3) Apply when the cost of the contractors that develop or draft grant (i) Ensure that small businesses, procurement is treated as a direct cost applications, or contract specifications, minority-owned firms, and women’s of an award. requirements, statements of work, business enterprises are used to the (b) Grantee responsibilities. The invitations for bids and requests for fullest extent practicable. standards contained in this section do proposals must be excluded from (ii) Make information on forthcoming not relieve the Grantee of the competing for such procurements. opportunities available and arrange time contractual responsibilities arising (3) Awards must be made to the frames for purchases and contracts to under its contract(s). bidder or offeror whose bid or offer is encourage and facilitate participation by (1) The grantee is the responsible responsive to the solicitation and is small businesses, minority-owned firms, authority, without recourse to the most advantageous to the grantee, price, and women’s business enterprises. Departmental awarding agency, quality, and other factors considered. (iii) Consider in the contract process regarding the settlement and satisfaction (4) Solicitations must clearly set forth whether firms competing for larger of all contractual and administrative all requirements that the bidder or contracts intend to subcontract with issues arising out of procurements offeror must fulfill in order for the bid small businesses, minority-owned firms, entered into in support of an award or or offer to be evaluated by the grantee. and women’s business enterprises. other agreement. This includes disputes, (5) Any and all bids or offers may be (iv) Encourage contracting with claims, and protests of award, source rejected when it is in the grantee’s consortia of small businesses, minority- evaluation or other matters of a interest to do so. owned firms and women’s business contractual nature. (e) Procurement procedures. All enterprises when a contract is too large (2) Matters concerning violation of grantees must establish written for one of these firms to handle statute are to be referred to such procurement procedures. These individually. Federal, State or local authority as may procedures must provide, at a (v) Use the services and assistance, as have proper jurisdiction. minimum, the following: appropriate, of such organizations as the (c) Codes of conduct. The grantee (1) Grantees avoid purchasing Small Business Administration and the must maintain written standards of unnecessary items. Department of Commerce’s Minority conduct governing the performance of (2) When appropriate, an analysis is Business Development Agency in the its employees engaged in the award and made of lease and purchase alternatives solicitation and utilization of small administration of contracts. to determine which would be the most businesses, minority-owned firms and (1) No employee, officer, or agent economical and practical procurement women’s business enterprises. must participate in the selection, award, for the grantee and the Federal (5) The type of procuring instruments or administration of a contract government. used (for example, fixed price contracts, supported by Federal funds if a real or (3) Solicitations for goods and cost reimbursable contracts, purchase apparent conflict of interest would be services provide for all of the following: orders, and incentive contracts) must be involved. (i) A clear and accurate description of determined by the grantee but must be (2) Such a conflict would arise when the technical requirements for the appropriate for the particular the employee, officer, or agent, or any material, product or service to be procurement and for promoting the best member of his or her immediate family, procured. In competitive procurements, interest of the program or project his or her partner, or an organization such a description must not contain involved. which employs or is about to employ features which unduly restrict (6) The ‘‘cost-plus-a-percentage-of- any of the parties indicated herein, has competition. cost’’ or ‘‘percentage of construction a financial or other interest in the firm (ii) Requirements which the bidder or cost’’ methods of contracting must not selected for an award. offer must fulfill and all other factors to be used. (3) The officers, employees, and be used in evaluating bids or proposals. (7) Contracts must be made only with agents of the grantee must neither solicit (iii) A description, whenever responsible contractors who possess the nor accept gratuities, favors, or anything practicable, of technical requirements in potential ability to perform successfully of monetary value from contractors, or terms of functions to be performed or under the terms and conditions of the parties to subagreements. performance required, including the proposed procurement. (4) Grantees may set standards for range of acceptable characteristics or (8) Consideration must be given to situations in which the financial interest minimum acceptable standards. such matters as contractor integrity, is not substantial or the gift is an (iv) The specific features of brand record of past performance, financial unsolicited item of nominal value. name or equal descriptions that bidders and technical resources or accessibility (5) The standards of conduct provide are required to meet when such items to other necessary resources. for disciplinary actions to be applied for are included in the solicitation. (9) In certain circumstances, contracts violations of such standards by officers, (v) The acceptance, to the extent with certain parties are restricted by employers, or agents of the grantees. practicable and economically feasible, agencies’ implementation of Executive (d) Competition. All procurement of products and services dimensioned in Orders 12549 and 12689, ‘‘Debarment transactions must be conducted in a the metric system of measurement. and Suspension’’ as described in 45 CFR manner to provide, to the maximum (vi) Preference, to the extent part 76. extent practical, open and free practicable and economically feasible, (10) Some form of cost or price competition. for products and services that conserve analysis must be made and documented (1) The grantee must be alert to natural resources and protect the in the procurement files in connection organizational conflicts of interest as environment and are energy efficient. with every procurement action. well as noncompetitive practices among (4) Positive efforts must be made by (11) Price analysis may be contractors that may restrict or grantees to utilize small businesses, accomplished in various ways, eliminate competition or otherwise minority-owned firms, and women’s including the comparison of price restrain trade. business enterprises, whenever possible. quotations submitted, market prices,

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and similar indicia, together with examinations, excerpts and modifications thereof and associated discounts. transcriptions. documentation designed, developed or (12) Cost analysis is the review and installed with FFP under this Subpart. evaluation of each element of cost to § 495.350 State Medicaid agency (b) Federal license. The Department attestations. determine reasonableness, allocability, reserves a royalty-free, nonexclusive, and allowability. (a) The State must provide assurances and irrevocable license to reproduce, (13) Procurement records and files for to the Department that amounts publish, or otherwise use and to purchases in excess of the simplified received with respect to sums expended authorize others to use for Federal acquisition threshold must include the that are attributable to payments to a government purposes, such software, following at a minimum: Medicaid provider for the adoption of modifications, and documentation. (i) Basis for contractor selection. EHR are paid directly to such provider, (c) Proprietary software. Proprietary (ii) Justification for lack of or to an employer or facility to which operating/vendor software packages competition when competitive bids or such provider has assigned payments, such as software that is owned and offers are not obtained. without any deduction or rebate. licensed for use by third parties, which (iii) Basis for award cost or price. (b) State Medicaid agency attestations are provided at established catalog or (f) Contract administration. A system must be provided in accordance with market prices and sold or leased to the for contract administration must be § 433.74 of this chapter. general public must not be subject to the maintained to ensure contractor ownership provisions in paragraphs (a) conformance with the terms, conditions § 495.352 Reporting requirements. and (b) of this section. and specifications of the contract and to Each State must submit to the (d) Limitation. Federal financial ensure adequate and timely follow-up of Department on a quarterly basis a participation is not available for all purchases. Grantees must evaluate progress report documenting specific proprietary applications software contractor performance and document, implementation and oversight activities developed specifically for the public as appropriate, whether contractors performed during the quarter, including assistance programs covered under this have met the terms, conditions, and progress in implementing the State’s subpart. specifications of the contract. approved Medicaid HIT plan. (g) Additional contract requirements. § 495.354 Rules for charging equipment. § 495.362 Retroactive approval of FFP with The grantee must include, in addition to an effective date of February 18, 2009. Equipment acquired under this provisions to define a sound and For administrative activities complete agreement, the following subpart is subject to the public assistance program requirements performed by a State, without obtaining provisions in all contracts, which must prior approval, which are in support of also be applied to subcontracts: concerning the computation of claims for Federal financial participation in planning for incentive payments to (1) Contracts in excess of the providers, a State may request simplified acquisition threshold must accordance with the provisions of 45 CFR part 95, subpart G. consideration of FFP by recorded contain contractual provisions or request in a HIT advance planning conditions that allow for administrative, § 495.356 Nondiscrimination document or implementation advance contractual, or legal remedies in requirements. planning document update. In such a instances in which a contractor violates State agencies and any other consideration, the agency takes into or breaches the contract terms, and recipients or subrecipients of Federal consideration overall Federal interests provide for such remedial actions as financial assistance provided under this which may include any of the following: may be appropriate. subpart are subject to the (a) The acquisition must not be before (2) All contracts in excess of the nondiscrimination requirements in 45 February 18, 2009. simplified acquisition threshold CFR parts 80, 84, and 91. (b) The acquisition must be (currently $100,000) must contain (a) These regulations in 45 CFR parts reasonable, useful, and necessary. suitable provisions for termination by 80, 84, and 91 prohibit individuals from (c) The acquisition must be the grantee, including the manner by being excluded from participation in, attributable to payments for reasonable which termination must be effected and being denied the benefits of, or being administrative expenses under section the basis for settlement. otherwise subjected to discrimination 1903(a)(3)(F)(ii) of the Act. (h) Conditions for default or under any program or activity which termination. Such contracts must § 495.364 Review and assessment of received Federal financial assistance. administrative activities and expenses of describe conditions under which the (b) Specifically, 45 part 80 prohibits contract may be terminated for default Medicaid provider health information discrimination on the basis of race, technology adoption and operation. as well as conditions where the contract color, or national origin; 45 CFR part 84 (a) CMS conducts periodic reviews on may be terminated because of prohibits discrimination on the basis of an as needed basis to assess the State’s circumstances beyond the control of the disability; and 45 CFR part 91 prohibits progress described in its approved HIT contractor. discrimination on the basis of age. (i) Access to contract materials and planning advance planning document staff. All negotiated contracts (except § 495.358 Cost allocation plans. and health information technology those for less than the simplified State agencies that acquire HIT implementation advance planning acquisition threshold) awarded by equipment and services under this document. grantees must include a provision to the subpart are subject to cost allocation (b) During planning, development, effect that the grantee, the Departmental plan requirements in 45 CFR part 95. and implementation, these reviews will awarding agency, the U.S. Comptroller generally be limited to the overall General, or any of their duly authorized § 495.360 Software and ownership rights. progress, work performance, representatives, must have access to any (a) General rule. The State or local expenditure reports, project deliverables books, documents, papers and records government must include a clause in all and supporting documentation. and staff of the contractor which are procurement instruments that provides (c) CMS assesses the State’s overall directly pertinent to a specific program that the State or local government will compliance with the approved advance for the purpose of making audits, have all ownership rights in software or planning document and provide

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technical assistance and information participate in the EHR incentive are used to make Medicaid EHR sharing from other State projects. payment program has or will have a NPI incentive payments. (d) CMS will, on a continuing basis, and will choose only one program from (5) Subject to § 495.332, the State review, assess and inspect the planning, which to receive the incentive payment must have a process in place to assure design, development, implementation, using the NPI, a TIN, and CMS’ national that Medicaid EHR incentive payments and operation of activities and provider election database. are not paid at amounts higher than 85 payments for reasonable administrative (c) Meaningful use and efforts to percent of the net average allowable cost expenses related to the administration adopt, implement, or upgrade to of certified EHR technology and the of payment for Medicaid provider HIT certified electronic health record yearly maximum allowable payment adoption and operation payments to technology to make payment. Subject to thresholds. determine the extent to which such §§ 495.354 and 495.374, the State must (6) Subject to § 495.332, the State activities meet the following: annually collect and verify information must have a process in place to assure (1) All requirements of this subpart. regarding the efforts to adopt, that for those entities promoting the (2) The goals and objectives stated in implement, or upgrade certified EHR adoption of EHR technology, the the approved HIT implementation technology and the meaningful use of Medicaid EHR incentive payments are advance planning document and State said technology before making any paid on a voluntary basis and that these Medicaid HIT plan. payments to providers. entities do not retain more than 5 (3) The schedule, budget, and other (d) Claiming Federal reimbursement percent of such payments for costs not conditions of the approved HIT for State expenditures. Subject to related to certified EHR technology. implementation advance planning § 495.332, the State must do the (7) Subject to § 495.332, the State document and State Medicaid HIT plan. following: must have a process in place to assure (1) Assure that State expenditures are that any existing fiscal relationships § 495.366 Financial oversight and with providers to disburse the incentive monitoring of expenditures. claimed in accordance with, including through Medicaid managed care plans (a) General rule. (1) The State must but not limited to, applicable Federal laws, regulations, and policy guidance. does not exceed 105 percent of the have a process in place to estimate capitation rate, in order to comply with expenditures for the Medicaid EHR (2) Have a process in place to assure that expenditures for administering the the Medicaid managed care incentive payment incentive program using the payment rules at § 438.6(c)(5)(iii) of this Medicaid Budget Expenditure System. Medicaid EHR incentive payment program will not be claimed at amounts chapter and a methodology for verifying (2) The State must have a process in such information. place to report actual expenditures for higher than 90 percent of the cost of such administration. (8) The State must not request the Medicaid EHR payment incentive reimbursement for Federal financial program using the Medicaid Budget (3) Have a process in place to assure that expenditures for payment of participation unless all requirements of Expenditure System. this subpart have been satisfied. (3) The State must have an automated Medicaid EHR incentive payments will payment and information retrieval not be claimed at amounts higher than § 495.368 Combating fraud and abuse. mechanized system (Medicaid 100 percent of the cost of such (a) General rule. (1) The State must Management Information System) to payments to Medicaid providers. comply with Federal requirements to— make EHR payment incentives, to (e) Improper Medicaid electronic (i) Ensure the qualifications of the ensure Medicaid provider eligibility, to health record payment incentives. providers who request Medicaid EHR ensure the accuracy of payment (1) Subject to § 495.332, the State incentive payments; incentives, and to identify potential must have a process in place to assure (ii) Detect improper payments; and improper payments. that no duplicate Medicaid EHR (iii) In accordance with 42 CFR (b) Provider eligibility as basis for payment incentives are paid between § 455.15 and § 455.21, refer suspected making payment. Subject to § 495.332, the Medicare and Medicaid programs, or cases of fraud and abuse to the Medicaid the State must do all of the following: paid by more than one State even if the Fraud Control Unit. (1) Collect and verify basic provider is licensed to practice in (2) The State must take corrective information on Medicaid providers to multiple States, or paid within more action in the case of improper EHR assure provider enrollment eligibility than one area of a State. payment incentives to Medicaid upon enrollment or re-enrollment to the (2) Subject to § 495.332, the State providers. Medicaid EHR payment incentive must have a process in place to assure (b) Providers’ statements regarding program. that Medicaid EHR incentive payments submission of documentation (2) Collect and verify basic are made without reduction or rebate, containing falsification or concealment information on Medicaid providers to have been paid directly to an eligible of a material fact on EHR incentive assure patient volume. provider or to an employer, a facility, or payment documentation. On any forms (3) Collect and verify basic an eligible third-party entity to which on which a provider submits information on Medicaid providers to the Medicaid eligible provider has information necessary to the assure that EPs are not hospital-based assigned payments. determination of eligibility to receive including the determination that (3) Subject to § 495.332, the State EHR incentive payments, the State must substantially all health care services are must have a process in place to assure obtain the statement that meet the not furnished in a hospital setting, that Medicaid EHR incentive payments following: either inpatient or outpatient. are made for no more than 6 years or for (1) Is signed by the provider and (4) Collect and verify basic any year starting after the year of 2015 contains the following statement: ‘‘This information on Medicaid providers to unless the provider has been provided is to certify that the foregoing assure that EPs are practicing payment under paragraph (b)(1) of this information is true, accurate, and predominantly in a Federally qualified section for the previous year. complete. I understand that Medicaid health center or rural health clinic. (4) Subject to § 495.332, the State EHR incentive payments submitted (5) Have a process in place to assure must have a process in place to assure under this provider number will be from that Medicaid providers who wish to that only appropriate funding sources

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Federal funds, and that any falsification, provisions of Federal criminal law, the submitting documents or data or both to or concealment of a material fact may be False Claims Act (32 U.S.C. 3729 et support the provider’s claim. prosecuted under Federal and State seq.), and the anti-kickback statute (2) That such process employs laws.’’ (section 1128B(b) of the Act). methods for conducting an appeal that (2) Appears directly above the are consistent with the State’s claimant’s signature, or if it is printed § 495.370 Appeals process for a Medicaid provider receiving electronic health record Administrative Procedure law(s). on the reverse of the form, a reference incentive payments. (c) The State must provide that the to the statements must appear provider (whether individual or entity) (a) The State must have a process in immediately preceding the provider’s is also given any additional appeals place consistent with the requirements signature. rights that would otherwise be available established in § 447.253(e) of this (3) Is resubmitted upon a change in under procedures established by the chapter for a provider or entity to appeal provider representative. State. (4) Is updated as needed. the following issues related to the HIT (c) Overpayments. States must repay incentives payment program: (Catalog of Federal Domestic Assistance (1) Incentive payments. Program No. 93.773, Medicare—Hospital to CMS all Federal financial Insurance; and Program No. 93.774, participation received by providers (2) Incentive payment amounts. Medicare—Supplementary Medical identified as an overpayment regardless (3) Provider eligibility determinations. Insurance Program, Program No. 93.778, or recoupment from such providers, (4) Demonstration of adopting, Medical Assistance Program.) implementing, and upgrading, and within 60 days of discovery of the Dated: November 13, 2009. overpayment, in accordance with meaningful use eligibility for incentives Charlene Frizzera, sections 1903(a)(1), (d)(2), and (d)(3) of under this subpart. the Act and part 433 Subpart F of the (b) Subject to paragraph (a) of this Acting Administrator, Centers for Medicare & Medicaid Services. regulations. section, the State’s process must ensure (d) Complying with Federal laws and the following: Approved: December 28, 2009. regulations. States must comply with all (1) That the provider (whether an Kathleen Sebelius, Federal laws and regulations designed individual or an entity) has an Secretary. to prevent fraud, waste, and abuse, opportunity to challenge the State’s [FR Doc. E9–31217 Filed 12–30–09; 4:15 pm] including, but not limited to applicable determination under this Part by BILLING CODE 4120–01–P

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Part III

Department of Health and Human Services 45 CFR Part 170 Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Interim Final Rule

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DEPARTMENT OF HEALTH AND comments. Attachments should be in Acronyms HUMAN SERVICES Microsoft Word, WordPerfect, or Excel; AHIC American Health Information however, we prefer Microsoft Word. Community Office of the Secretary http://www.regulations.gov. ANSI American National Standards • Regular, Express, or Overnight Mail: Institute 45 CFR Part 170 Department of Health and Human ASP Application Service Provider CAH Critical Access Hospital RIN 0991–AB58 Services, Office of the National Coordinator for Health Information CCD Continuity of Care Document CCHIT Certification Commission for Health Health Information Technology: Initial Technology, Attention: HITECH Initial Information Technology Set of Standards, Implementation Set Interim Final Rule, Hubert H. CCR Continuity of Care Record Specifications, and Certification Humphrey Building, Suite 729D, 200 CDA Clinical Document Architecture Criteria for Electronic Health Record Independence Ave., SW., Washington, CDC Centers for Disease Control and Technology DC 20201. Please submit one original Prevention and two copies. CFR Code of Federal Regulations AGENCY: Office of the National • Hand Delivery or Courier: Office of CGD Certification Guidance Document Coordinator for Health Information CMS Centers for Medicare & Medicaid the National Coordinator for Health Services Technology, Department of Health and Information Technology, Attention: Human Services. CPOE Computerized Provider Order Entry HITECH Initial Set Interim Final Rule, EHR Electronic Health Record ACTION: Interim final rule. Hubert H. Humphrey Building, Suite FIPS Federal Information Processing 729D, 200 Independence Ave., SW., Standards SUMMARY: The Department of Health and Washington, DC 20201. Please submit GIPSE Geocoded Interoperable Population Human Services (HHS) is issuing this one original and two copies. (Because Summary Exchange interim final rule with a request for access to the interior of the Hubert H. HHS Department of Health and Human comments to adopt an initial set of Humphrey Building is not readily Services standards, implementation HIPAA Health Insurance Portability and available to persons without federal specifications, and certification criteria, Accountability Act of 1996 government identification, commenters as required by section 3004(b)(1) of the HIT Health Information Technology are encouraged to leave their comments Public Health Service Act. This interim HITECH Health Information Technology for in the mail drop slots located in the final rule represents the first step in an Economic and Clinical Health main lobby of the building.) HITSP Healthcare Information Technology incremental approach to adopting Inspection of Public Comments: All Standards Panel standards, implementation HL7 Health Level Seven specifications, and certification criteria comments received before the close of the comment period will be available for ICD International Classification of Diseases to enhance the interoperability, ICD–9–CM ICD, 9th Revision, Clinical functionality, utility, and security of public inspection, including any Modifications health information technology and to personally identifiable or confidential ICD–10–PCS ICD, 10th Revision, Procedure support its meaningful use. The business information that is included in Coding System certification criteria adopted in this a comment. Please do not include ICD–10–CM ICD, 10th Revision, Related initial set establish the capabilities and anything in your comment submission Health Problems IHS Indian Health Service related standards that certified that you do not wish to share with the general public. Such information LOINC Logical Observation Identifiers electronic health record (EHR) Names and Codes technology will need to include in order includes, but is not limited to: A person’s social security number; date of MA Medicare Advantage to, at a minimum, support the NCPDP National Council for Prescription achievement of the proposed birth; driver’s license number; state Drug Programs meaningful use Stage 1 (beginning in identification number or foreign country NCVHS National Committee on Vital and 2011) by eligible professionals and equivalent; passport number; financial Health Statistics eligible hospitals under the Medicare account number; credit or debit card NLM National Library of Medicine and Medicaid EHR Incentive Programs. number; any personal health NQF National Quality Forum information; or any business OASIS Organization for the Advancement DATES: Effective Date: This interim final information that could be considered to of Structured Information Standards rule is effective February 12, 2010. The be proprietary. We will post all OCR Office for Civil Rights incorporation by reference of certain comments received before the close of OIG Office of Inspector General publications listed in the rule is OMB Office of Management and Budget the comment period at http:// ONC Office of the National Coordinator for approved by the Director of the Federal www.regulations.gov. Register as of February 12, 2010. Health Information Technology Docket: For access to the docket to Comment Date: To be assured PHSA Public Health Service Act read background documents or PQRI Physician Quality Reporting Initiative consideration, written or electronic comments received, go to http:// REST Representational state transfer comments must be received at one of www.regulations.gov or U.S. Department RFA Regulatory Flexibility Act the addresses provided below, no later of Health and Human Services, Office of SDOs Standards Development than 5 p.m. on March 15, 2010. the National Coordinator for Health Organizations ADDRESSES: Because of staff and SNOMED CT Systematized Nomenclature Information Technology, Hubert H. of Medicine Clinical Terms resource limitations, we cannot accept Humphrey Building, Suite 729D, 200 comments by facsimile (FAX) SOAP Simple Object Access Protocol Independence Ave., SW., Washington, UCUM Unified Code for Units of Measure transmission. You may submit DC 20201 (call ahead to the contact UMLS Unified Medical Language System comments, identified by RIN 0991– listed below to arrange for inspection). UNII Unique Ingredient Identifier AB58, by any of the following methods XML eXtensible Markup Language (please do not submit duplicate FOR FURTHER INFORMATION CONTACT: comments). Steven Posnack, Policy Analyst, 202– Table of Contents 690–7151. • Federal eRulemaking Portal: Follow I. Background the instructions for submitting SUPPLEMENTARY INFORMATION: A. ONC Background

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B. Interdependencies With Other HITECH A. Introduction care provider to improve the quality, Provisions and Relationship to Other B. Why Is This Rule Needed? safety and efficiency of the care they Regulatory Requirements and Related C. Costs and Benefits deliver. Activities 1. Costs We note that ordinarily we publish a 1. Medicare and Medicaid EHR Incentive 2. Benefits notice of proposed rulemaking in the Programs Proposed Rule D. Regulatory Flexibility Act Analysis 2. Health Insurance Portability and E. Executive Order 13132—Federalism Federal Register and invite public Accountability Act of 1996 (HIPAA) F. Unfunded Mandates Reform Act of 1995 comment on the proposed rule. The Privacy Rule Accounting of Disclosures Regulation Text notice of proposed rulemaking includes Regulation a reference to the legal authority under 3. Previous Recognition of Certification I. Background which the rule is proposed, and the Bodies and New Authority Under the The Health Information Technology terms and substances of the proposed HITECH Act for Economic and Clinical Health Act rule or a description of the subjects and 4. Other HHS Regulatory Actions (HITECH Act), Title XIII of Division A issues involved. As mentioned above, a. Health Insurance Portability and and Title IV of Division B of the however, section 3004(b)(1) explicitly Accountability Act of 1996 (HIPAA) American Recovery and Reinvestment Transactions and Code Sets Standards authorizes the Secretary to issue this b. Electronic Prescribing Standards Act of 2009 (ARRA) (Pub. L. 111–5), was rule on an interim final basis. Moreover, C. Standards, Implementation enacted on February 17, 2009. The section 3004(b)(1) requires the Secretary Specifications, and Certification Criteria HITECH Act amended the Public Health to adopt an initial set of standards, Processes Before and After the HITECH Service Act (PHSA) and created ‘‘Title implementation specifications, and Act XXX—Health Information Technology certification criteria by December 31, 1. ONC’s Processes Prior to the HITECH and Quality’’ to improve health care 2009. We have therefore decided to Act quality, safety, and efficiency through proceed directly with this interim final 2. HITECH Act Requirements for the the promotion of health information rule. Nevertheless, we are providing the Adoption of Standards, Implementation technology (HIT) and the electronic Specifications, and Certification Criteria public with a 60-day period following D. Future Updates to Standards, exchange of health information. Section publication of this document to submit Implementation Specifications, and 3004(b)(1) of the PHSA requires the comments on the interim final rule. Certification Criteria Secretary of the Department of Health The following discussion provides the II. Overview of the Interim Final Rule and Human Services (the Secretary) to background information relevant to the III. Section-By-Section Description of the adopt an initial set of standards, Secretary’s adoption of an initial set of Interim Final Rule implementation specifications, and standards, implementation A. Applicability certification criteria by December 31, specifications, and certification criteria. B. Definitions 2009 to enhance the interoperability, A. ONC Background 1. Definition of Standard functionality, utility, and security of 2. Definition of Implementation health information technology. It also Executive Order 13335 (69 FR 24059) Specification permits the Secretary to adopt this established the Office of the National 3. Definition of Certification Criteria Coordinator for Health Information 4. Definition of Qualified Electronic Health initial set through an interim final rule. Record (EHR) The certification criteria adopted in Technology (ONC) on April 24, 2004. In 5. Definition of EHR Module this initial set establish the capabilities an effort to ‘‘provide leadership for the 6. Definition of Complete EHR and related standards that certified development and nationwide 7. Definition of Certified EHR Technology electronic health record (EHR) implementation of an interoperable 8. Definition of Disclosure technology (Certified EHR Technology) health information technology C. Initial Set of Standards, Implementation will need to include in order to, at a infrastructure to improve the quality Specifications, and Certification Criteria minimum, support the achievement of and efficiency of health care,’’ the 1. Adopted Certification Criteria the proposed meaningful use Stage 1 by President directed the Secretary to 2. Adopted Standards eligible professionals and eligible create within the Office of the Secretary a. Transport Standards the position of National Health b. Content Exchange and Vocabulary hospitals under the Medicare and Standards Medicaid EHR Incentive Programs. Information Technology Coordinator i. Patient Summary Record Throughout this interim final rule, we (National Coordinator). The National ii. Drug Formulary Check routinely refer to eligible professionals Coordinator was charged with: Serving iii. Electronic Prescribing and eligible hospitals. This is done as the Secretary’s principal advisor on iv. Administrative Transactions because we have closely aligned the the development, application, and use v. Quality Reporting initial set of standards, implementation of HIT and directing the HHS HIT vi. Submission of Lab Results to Public specifications, and certification criteria programs; ensuring that the HIT policy Health Agencies adopted by this rule to focus on the and programs of HHS were coordinated vii. Submission to Public Health Agencies capabilities that Certified EHR with those of relevant Executive Branch for Surveillance or Reporting viii. Submission to Immunization Technology must be able to provide in agencies; to the extent permitted by law, Registries order to support the achievement of the coordinating outreach and consultation ix. Table 2A proposed criteria for meaningful use by the relevant Executive Branch c. Privacy and Security Standards Stage 1 by eligible professionals and agencies with public and private parties 3. Adopted Implementation Specifications eligible hospitals under the Medicare of interest; and at the request of the 4. Additional Considerations, and Medicaid EHR Incentive Programs. Office of Management and Budget Clarifications, and Requests for Public This initial focus is not meant to limit (OMB), providing comments and advice Comments or preclude health care providers who regarding specific Federal HIT a. Relationship to Other Federal Laws do not meet the definitions of eligible programs. Additionally, the National b. Human Readable Format c. Certification Criterion and Standard professional or eligible hospital from Coordinator was required, to the extent Regarding Accounting of Disclosures obtaining or adopting Certified EHR permitted by law, to develop, maintain, d. Additional Requests for Public Comment Technology. To the contrary, Certified and direct the implementation of a IV. Collection of Information Requirements EHR Technology will possess the strategic plan to guide the nationwide V. Regulatory Impact Analysis capabilities that can assist any health implementation of interoperable HIT in

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both the public and private health care certified EHR technology in a Programs proposed rule, we have sectors. Included in Executive Order meaningful manner.’’ This means that to adopted certification criteria that 13335 as a strategic plan objective, was qualify for incentives, an eligible directly support CMS’s proposed the goal to ‘‘advance the development, professional or eligible hospital must meaningful use Stage 1 objectives. The adoption, and implementation of health both adopt Certified EHR Technology stages of meaningful use are described care information technology standards and demonstrate meaningful use of this and have been proposed by CMS in the nationally through collaboration among technology. Congress further specified Medicare and Medicaid EHR Incentive public and private interests, and that Certified EHR Technology must be Programs proposed rule as the consistent with current efforts to set certified as meeting the standards following: health information technology standards adopted by the Secretary, which we • Stage 1 (beginning in 2011): The for use by the Federal Government.’’ adopt in this rule. As referenced in the proposed Stage 1 meaningful use Section 3001 of the PHSA establishes preamble to the Medicare and Medicaid criteria ‘‘focuses on electronically by statute the ONC within HHS and EHR Incentives Program proposed rule capturing health information in a coded provides the National Coordinator with the Medicare and/or Medicaid incentive format; using that information to track additional responsibilities and duties payments are available to certain key clinical conditions and beyond those originally identified in eligible professionals and eligible communicating that information for care Executive Order 13335. Specifically, the hospitals. coordination purposes (whether that National Coordinator is charged with, We have adopted standards, information is structured or among other duties: Reviewing and implementation specifications, and unstructured, but in structured format determining whether to endorse each certification criteria in this interim final whenever feasible); consistent with standard, implementation specification, rule in part to assure that Certified EHR other provisions of Medicare and and certification criterion that is Technology is capable of supporting the Medicaid law, implementing clinical recommended by the HIT Standards achievement of meaningful use by decision support tools to facilitate Committee (a Federal advisory eligible professionals and eligible disease and medication management; committee to the National Coordinator) hospitals under the Medicare and and reporting clinical quality measures and making such determinations and Medicaid EHR Incentive Programs. The and public health information.’’ reporting them to the Secretary; certification criteria, adopted by the • Stage 2 (beginning in 2013): CMS reviewing Federal HIT investments to Secretary, must be used to test and has proposed that its goals for the Stage ensure they meet the objectives of the certify that Complete EHRs or EHR 2 meaningful use criteria, ‘‘consistent Federal HIT Strategic Plan; coordinating Modules have properly implemented with other provisions of Medicare and the HIT policy and programs of HHS the capabilities required by the Medicaid law, expand upon the Stage 1 with those of other relevant Federal certification criteria and, where criteria to encourage the use of health IT agencies; serving as a leading member in appropriate, the standards and for continuous quality improvement at the establishment and operations of the implementation specifications adopted the point of care and the exchange of HIT Policy Committee and HIT by the Secretary. ONC and the Centers information in the most structured Standards Committee; updating the for Medicare & Medicaid Services (CMS) format possible, such as the electronic Federal HIT Strategic Plan in have worked carefully to ensure that transmission of orders entered using consultation with other appropriate this interim final rule and the Medicare computerized provider order entry Federal agencies and through and Medicaid EHR Incentive Programs (CPOE) and the electronic transmission collaboration with public and private proposed rule are aligned. of diagnostic test results (such as blood entities; keeping or recognizing a To inform our collaborative tests, microbiology, urinalysis, program or programs to certify EHR rulemaking processes, ONC and CMS pathology tests, radiology, cardiac technology; conducting studies and received input from hundreds of imaging, nuclear medicine tests, reports; and establishing a governance technical subject matter experts, health pulmonary function tests and other such mechanism for the Nationwide Health care providers, and other stakeholders data needed to diagnose and treat Information Network (NHIN). who provided written comments to, disease). Additionally we may consider testified before, and attended meetings applying the criteria more broadly to B. Interdependencies With Other held by three HHS Federal advisory both the inpatient and outpatient HITECH Provisions and Relationship to committees: the National Committee on hospital settings.’’ Other Regulatory Requirements and Vital and Health Statistics, the HIT • Stage 3 (beginning in 2015): CMS Related Activities Policy Committee, and the HIT has proposed that its goals for the Stage The HITECH Act creates multiple Standards Committee. After several 3 meaningful use criteria are, interdependencies between this interim meetings of its workgroups and the full ‘‘consistent with other provisions of final rule and other regulatory committee, the HIT Policy Committee Medicare and Medicaid law, to focus on requirements, processes, and programs. presented and recommended to the promoting improvements in quality, National Coordinator at its July 16, 2009 safety and efficiency, focusing on 1. Medicare and Medicaid EHR meeting a matrix on meaningful use of decision support for national high Incentive Programs Proposed Rule Certified EHR Technology that priority conditions, patient access to self In writing the provisions of the contained: Overall health outcome management tools, access to HITECH Act, Congress fundamentally policy priorities; health care goals; draft comprehensive patient data and tied the standards, implementation objectives for eligible professionals and improving population health.’’ specifications, and certification criteria eligible hospitals for 2011 (beginning of adopted in this interim final rule to the meaningful use Stage 1), 2013 2. Health Insurance Portability and incentives available under the Medicare (beginning of meaningful use Stage 2), Accountability Act of 1996 (HIPAA) and Medicaid EHR Incentive Programs and 2015 (beginning of meaningful use Privacy Rule Accounting of Disclosures by requiring the meaningful use of Stage 3); and specific measures for each Regulation Certified EHR Technology. Congress of those years. With respect to this Section 13405(c) of the HITECH Act outlined several goals for meaningful interim final rule’s relationship to the requires the Secretary to promulgate use one of which includes the ‘‘use of Medicare and Medicaid EHR Incentive regulations on what information shall be

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collected about disclosures for HITECH Act and the additional purpose implementation timetables. We have treatment, payment, or health care to which the certification of the HIT is ensured that our standards and operations made ‘‘through an electronic now tied (qualifying for incentive implementation specifications are health record’’ by a HIPAA covered payments) in combination with ONC’s consistent with the previously adopted entity. These regulations, which will be current responsibilities under the CGD, HIPAA transactions and code sets issued by the Secretary through the HHS we have decided to propose in a standards and with the established Office for Civil Rights, must be issued separate rulemaking, processes to implementation timetable. Further, we not later than 6 months after the date on replace the CGD and establish HIT intend for our future adoption of which the Secretary adopts standards on certification programs as specified by standards and implementation accounting for disclosures described in section 3001(c)(5) of the PHSA. We have specifications for meaningful use Stage the section 3002(b)(2)(B)(iv) of the decided to proceed with a separate 2 and Stage 3 to continue to be PHSA. The certification criterion and notice and comment rulemaking (which consistent with the Secretary’s adoption standard associated with this we anticipate publishing shortly after and modification of HIPAA transactions requirement and included in this this interim final rule) to establish the and code sets standards and their interim final rule are discussed in more policies for the certification of HIT and detail below in section III.C.4.c. the process a certification body will timeframes for compliance. 3. Previous Recognition of Certification need to follow to become an authorized b. Electronic Prescribing Standards Bodies and New Authority Under the certification body, as determined by the The Medicare Prescription Drug, HITECH Act National Coordinator. Improvement and Modernization Act of Among other responsibilities, section 4. Other HHS Regulatory Actions 2003 (MMA) provided for, among other 3001(c)(5) of the PHSA expressly a. HIPAA Transactions and Code Sets things, the Voluntary Prescription Drug requires the National Coordinator, in Standards Benefit Program. Under that program, consultation with the Director of the electronically transmitted prescriptions National Institute of Standards and The Secretary has previously adopted and certain other information for Technology, to ‘‘keep or recognize a and modified transactions and code sets program or programs for the voluntary standards for HIPAA covered entities. covered Part D drugs prescribed for Part certification of health information Many of these same covered entities are D eligible individuals must be sent in a technology as being in compliance with now also eligible to qualify for incentive manner that complies with applicable applicable certification criteria adopted’’ payments under the Medicare and standards that are adopted by the by the Secretary under section 3004. Medicaid EHR Incentives Program. As a Secretary. The Secretary proposed the HHS’s recognition of certain bodies to result, we want to assure that Certified first of these standards in a February conduct HIT certification is not new as EHR Technology positions these eligible 2005 rulemaking (70 FR 6256). a result of the HITECH Act. In August professionals and eligible hospitals to Subsequently, on June 23, 2006 (71 FR 2006, HHS published two final rules in qualify for incentive payments and 36020), HHS published an interim final which CMS and the Office of Inspector comply with these transactions and rule that maintained the National General (OIG) promulgated an exception code set standards. Most recently, in Council for Prescription Drug Programs to the physician self-referral prohibition August 2008, HHS proposed through (NCPDP) SCRIPT 5.0 as the adopted and a safe harbor under the anti- two rules (73 FR 49742 and 73 FR standard, but allowed for the voluntary kickback statute, respectively, for 49796) the updating of electronic use of a subsequent backward certain arrangements involving the transaction standards, new transaction compatible version of the standard, standards, and the adoption of donation of interoperable EHR software NCPDP SCRIPT 8.1. to physicians and other health care International Classification of Diseases practitioners or entities (71 FR 45140 (ICD), 10th Revision, Related Health As a result of pilot testing of six and 71 FR 45110, respectively). The Problems (ICD–10–CM) and ICD, 10th ‘‘initial standards’’ that had been exception and safe harbor provide that Revision, Procedure Coding System identified in 2005, the Secretary issued EHR software will be ‘‘deemed to be (ICD–10–PSC) code sets to replace the a notice of proposed rulemaking on interoperable if a certifying body ICD, 9th Revision, Clinical November 16, 2007 (72 FR 64900) recognized by the Secretary has certified Modifications (ICD–9–CM) Volumes 1 which proposed adoption of certain the software no more than 12 months and 2, and the ICD–9–CM Volume 3 standards. The Secretary also used this prior to the date it is provided to the code sets, respectively. After reviewing proposed rule to solicit comments [physician/recipient].’’ ONC published and considering public comments on regarding the impact of adopting NCPDP separately a Certification Guidance these proposals, in January 2009, HHS SCRIPT 8.1 and retiring NCPDP SCRIPT Document (CGD) (71 FR 44296) to adopted in final rules published at 74 5.0. Based on the comments that were explain the factors ONC would use to FR 3296 and 74 FR 3328 certain received, the Secretary issued a final determine whether or not to recommend updated transaction standards, new rule (73 FR 18918) on April 7, 2008 that to the Secretary a body for recognized transaction standards, and code sets. adopted NCPDP SCRIPT Version 8.1 certification body status. The CGD The rules established a timeline for and retired NCPDP SCRIPT Version 5.0. serves as a guide for ONC to evaluate compliance with some of these updated In adopting an initial set of standards to standards and code sets. For example, applications for recognized certification meet the requirement specified at body status and provides the all HIPAA covered entities are required section 3004(b)(1) of the PHSA, we have information a body would need to apply to comply with ICD–10–CM and ICD– taken into account these electronic for and obtain such status. In section VI 10–PSC on and after October 1, 2013. prescribing standards and ensured that of the CGD, ONC notified the public and In adopting an initial set of standards potential applicants that the recognition and implementation specifications as our standards are consistent with them. process would be formalized through specified at section 3004(b)(1) of the notice and comment rulemaking. PHSA, we have taken into account After reviewing the new HIPAA transactions and code sets responsibilities assumed under the standards and their associated

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C. Standards, Implementation testimony from HITSP representatives implemented, acquired, or upgraded Specifications, and Certification Criteria several times on their standards ‘‘health information technology systems Processes Before and After the HITECH harmonization work in order to inform used for the direct exchange of health Act potential recommendations for the information between agencies and with Secretary. In many cases, after a non-Federal entities.’’ 1. ONC’s Processes Prior to the HITECH presentation by HITSP, AHIC would The third participant besides AHIC Act make recommendations to the Secretary and HITSP that played a role in ONC’s Prior to the enactment of the HITECH regarding standards and implementation prior processes was the Certification Act, ONC’s processes consisted of the specifications for recognition. The Commission for Health Information ‘‘acceptance’’ and ‘‘recognition’’ of HIT Secretary would subsequently review Technology (CCHIT). Founded in 2004, standards, implementation those recommendations and determine CCHIT established the first specifications, and certification criteria whether to recognize some or all of the comprehensive process to test and for the electronic exchange of health recommended standards and certify EHR technology. After information and electronic health implementation specifications. establishing a certification criteria records. This prior process and its Executive Order 13410 (71 FR 51089) development process that included participants are described in further acknowledged that the Secretary diverse stakeholders and a voluntary, detail below. recognizes interoperability standards for consensus-based approach, CCHIT Chartered in 2005, the American use by certain Federal agencies.1 This began certifying ambulatory EHR Health Information Community (AHIC), Executive Order also directed those technology in 2006. Since 2006, CCHIT a Federal advisory committee, was Federal agencies, to the extent permitted has expanded its certification program charged with making recommendations by law, to require in their contracts and to include inpatient EHR technology, to the Secretary on how to accelerate the agreements with certain organizations emergency department EHR technology, development and adoption of HIT. Until the use, where available, of health as well as its certification criteria for its sunset in November 2008, AHIC information technology systems and EHR technology to meet specific needs advanced to the Secretary several products that meet recognized of certain health care providers/ recommendations related to standards, interoperability standards. Executive specialists (e.g., cardiovascular, child implementation specifications, and Order 13410 was issued on August 28, health). On May 16, 2006, CCHIT certification criteria. To structure those 2006, to, among other goals, ensure that presented its 2006 ambulatory EHR recommendations, AHIC identified ‘‘use health care programs administered or certification criteria to AHIC and after cases’’ to prioritize areas in need of sponsored by the Federal government considering the criteria, AHIC harmonized standards and to enable promoted quality and efficient delivery recommended that the Secretary ONC to guide the work of organizations of health care through the use of health recognize CCHIT-identified certification with specific expertise in those priority information technology. On March 1, criteria for functionality, areas. A use case provided a description 2007, January 23, 2008, and January 29, interoperability, and security. of the activity of stakeholders, a 2009, HHS published notices in the This recommendation informed the sequence of their actions, and technical Federal Register (72 FR 9339, 73 FR Secretary’s decision to recognize the specifications for systems and 3973, 74 FR 3599, respectively) 2006 ambulatory EHR certification technologies involved when the actors announcing either the Secretary’s criteria for use by recognized engage in responding to or participating acceptance or recognition of certain certification bodies in conjunction with in such activity. standards and implementation published final rules for exceptions to Created in 2005 by the American specifications. In an effort to assist with the physician self-referral law and safe National Standards Institute (ANSI) the implementation and adoption harbors to the anti-kickback statute for under a contract with HHS, the challenges associated with recognized electronic prescribing and EHR software Healthcare Information Technology standards, the Secretary chose to first arrangements (71 FR 45140 and 71 FR Standards Panel (HITSP)—a cooperative ‘‘accept’’ and then formally ‘‘recognize’’ 45110, respectively). The exception and partnership of more than 500 public and one year after acceptance, specified safe harbor provide that EHR software private sector organizations—began its standards and implementation will be ‘‘deemed to be interoperable if a work to take into account AHIC specifications. This delay provided certifying body recognized by the identified use cases, as directed by Federal agencies with additional time to Secretary has certified the software no ONC. HITSP was established for the prepare for Executive Order 13410’s more than 12 months prior to the date purpose of harmonizing and integrating directive to ‘‘utilize, where available, it is provided to the [physician/ a widely accepted and useful set of health information technology systems recipient].’’ These provisions of the EHR standards to enable and support and products that meet recognized exception and safe harbor anticipated interoperability among healthcare interoperability standards’’ when they that: (1) HHS would recognize one or software systems and the organizations more EHR certifying bodies, and (2) and entities that utilize the systems. 1 Executive Order 13410 defines ‘‘agency’’ to mean HHS would recognize criteria for the HITSP also became a primary forum for ‘‘an agency of the Federal Government that certification of EHRs. The Federal HIT standards harmonization after the administers or sponsors a Federal health care Register notice (71 FR 44295) describing program.’’ It also defines ‘‘Federal health care Consolidated Health Informatics (CHI) program’’ as including ‘‘the Federal Employees the Secretary’s recognition of these initiative, which began in October 2001 Health Benefit Program, the Medicare program, certification criteria was published on as a collaborative effort to adopt Federal programs operated directly by the Indian Health August 4, 2006. government-wide interoperability Service, the TRICARE program for the Department Section 3004(b)(2) of the PHSA of Defense and other uniformed services, and the standards to be implemented by Federal health care program operated by the Department of provides that in adopting an initial set agencies, was gradually phased out. The Veterans Affairs.’’ For purposes of the Executive of standards, implementation CHI initiative adopted several standards Order, ‘‘Federal health care program’’ does not specifications, and certification criteria that were fed into and reused as part of include ‘‘State operated or funded federally in accordance with section 3004(b)(1), subsidized programs such as Medicaid, the State HITSP’s standards harmonization Children’s Health Insurance Program, or services the Secretary may adopt those processes. As a result, over the course provided to Department of Veterans’ Affairs standards, implementation of its three-year existence, AHIC sought beneficiaries under 38 U.S.C. 1703.’’ specifications, and certification criteria

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that went through the process priorities for standards, implementation electronic use and accurate exchange of established by ONC before the date of specifications, and certification criteria health information; the enactment of the HITECH Act. We while the HIT Standards Committee is (3) The utilization of a certified electronic believe that in separately requiring the responsible for recommending health record for each person in the United ‘‘ ’’ States by 2014; Secretary to adopt an initial set of standards, implementation (4) Technologies that as a part of a standards, implementation specifications, and certification criteria qualified electronic health record allow for specifications, and certification criteria for adoption under section 3004 of the an accounting of disclosures made by a under section 3004(b)(1) of the PHSA, PHSA. covered entity (as defined for purposes of Congress provided the Secretary with Section 3002 of the PHSA directs the regulations promulgated under section 264(c) the discretion to adopt standards, HIT Policy Committee to ‘‘make policy of the Health Insurance Portability and implementation specifications, or recommendations to the National Accountability Act of 1996) for purposes of certification criteria which had not gone Coordinator relating to the treatment, payment, and health care through the prior process. As described implementation of a nationwide health operations (as such terms are defined for above, while the prior process included information technology infrastructure.’’ purposes of such regulations); Section 3002(b) further specifies the (5) The use of certified electronic health a significant body of work it did not records to improve the quality of health care, encompass the entirety of the areas type of policy recommendations such as by promoting the coordination of Congress requested the Secretary to expected of the HIT Policy Committee health care and improving continuity of focus on in the HITECH Act, nor did it by requiring that the committee focus on health care among health care providers, by envision the policies and capabilities ‘‘specific areas of standards reducing medical errors, by improving that would be necessary for Certified development’’ and in so doing population health, by reducing health EHR Technology to meet the proposed ‘‘recommend the areas in which disparities, by reducing chronic disease, and definition of meaningful use Stage 1 standards, implementation by advancing research and education; included in the Medicare and Medicaid specifications, and certification criteria (6) Technologies that allow individually EHR Incentive Programs proposed rule. are needed for the electronic exchange identifiable health information to be and use of health information for rendered unusable, unreadable, or As a result, we have, after considering indecipherable to unauthorized individuals the input received through the purposes of adoption under section when such information is transmitted in the recommendations of the HIT Policy 3004.’’ Section 3002(b) also requires the nationwide health information network or Committee and HIT Standards HIT Policy Committee, after physically transported outside of the secured, Committee, adopted an initial set of determining the areas where standards, physical perimeter of a health care provider, standards, implementation implementation specifications, and health plan, or health care clearinghouse; specifications, and certification criteria certification criteria are needed (a (7) The use of electronic systems to ensure to, at a minimum, support the process and analysis that are likely to the comprehensive collection of patient achievement of what is being proposed occur on a periodic basis), to demographic data, including, at a minimum, for meaningful use Stage 1. We have ‘‘recommend an order of priority for the race, ethnicity, primary language, and gender development, harmonization, and information; and noted in section III of this rule, where (8) Technologies that address the needs of applicable, those standards and recognition of such standards, children and other vulnerable populations. implementation specifications that were specifications, and certification criteria previously accepted or recognized by among the areas so recommended.’’ The HIT Policy Committee is also the Secretary under this prior process After receipt of a recommendation authorized at 3002(b)(2)(C) to consider and those that were not. Due to our related to a priority order, the National other areas to make recommendations approach of aligning adopted Coordinator is expected to review the such as the ‘‘appropriate uses of a certification criteria with the proposed priorities identified by the HIT Policy nationwide health information definition of meaningful use Stage 1, the Committee and generally will either infrastructure, including [for] * * * Secretary has decided not to adopt accept them as submitted, request collection of quality data and public previously recognized certification adjustments, or reject the priority order reporting,’’ ‘‘telemedicine,’’ and criteria developed in 2006 as any of the in whole or in part. Once the National ‘‘technologies that help reduce medical certification criteria in this interim final Coordinator accepts a recommendation errors.’’ rule. for the priority order of standards, Section 3003 of the PHSA directs the implementation specifications, and HIT Standards Committee to 2. HITECH Act Requirements for the certification criteria, such priorities will ‘‘recommend to the National Adoption of Standards, Implementation be communicated to the HIT Standards Coordinator standards, implementation Specifications, and Certification Criteria Committee to guide its work. The HIT specifications, and certification criteria With the passage of the HITECH Act, Policy Committee is charged with for the electronic exchange and use of two new Federal advisory committees, making recommendations in at least the health information for purposes of the HIT Policy Committee and the HIT following eight areas as specified in adoption under section 3004.’’ It also Standards Committee, were established section 3002(b)(2)(B) of the PHSA: established that the HIT Standards as specified in the new sections of the Committee must recommend standards, (1) Technologies that protect the privacy of implementation specifications, and PHSA, 3002 and 3003, respectively. health information and promote security in a Both are responsible for advising the qualified electronic health record, including certification criteria they have National Coordinator on different for the segmentation and protection from developed, harmonized, or recognized. aspects of standards, implementation disclosure of specific and sensitive We note that in section 3003(b)(2), the specifications, and certification criteria individually identifiable health information HIT Standards Committee is also and consequently they both have the with the goal of minimizing the reluctance of expressly permitted to recognize potential to impact how and when patients to seek care (or disclose information harmonized or updated standards from standards, implementation about a condition) because of privacy other entities and as a result, we expect concerns, in accordance with applicable law, specifications, and certification criteria and for the use and disclosure of limited data the HIT Standards Committee to, where are adopted by the Secretary. The HIT sets of such information; appropriate, consider the standards, Policy Committee is responsible for, (2) A nationwide health information implementation specifications, and among other duties, recommending technology infrastructure that allows for the certification criteria from various

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entities for recommendation to the National Coordinator, a time limited Our approach to the adoption of National Coordinator. We expect that in statutory process is triggered. First, after standards, implementation determining whether to recognize receiving a recommendation from the specifications, and certification criteria harmonized or updated standards from HIT Standards Committee, the National is pragmatic, but forward looking. While other entities, the HIT Standards Coordinator must review and determine a high-level of interoperability Committee will look to entities such as whether to endorse the recommendation nationwide will take time and be HITSP and the National Quality Forum as well as report such determination to challenging, we believe that the HITECH (NQF). Additionally, section 3003(a) the Secretary. Upon receipt of an Act has generated a significant amount requires the HIT Standards Committee ‘‘endorsed recommendation,’’ the of momentum and interest in meeting to focus on and make recommendations Secretary is required to consult with the challenges that lie ahead. to the National Coordinator on the eight representatives of other relevant Federal We recognize that interoperability and areas in section 3002(b)(2)(B) listed agencies to review the standards, standardization can occur at many above. The HIT Standards Committee is implementation specifications, or different levels. For example, one required to update their certification criteria and determine organization may use an information recommendations and make new whether to propose their adoption. The model to describe patient demographic recommendations as appropriate, Secretary is required to publish all information as (PatientAge, PatientSex, including in response to a notification determinations in the Federal Register. StreetAddress), while another may sent under section 3004(a)(2)(B) of the If the Secretary determines to propose describe similar demographic PHSA. the adoption of standards, information in a different way Section 3004 of the PHSA redefines implementation specifications, or (DateOfBirth, Gender, City/State). To how the Secretary adopts standards, certification criteria, the Secretary is achieve interoperability at this implementation specifications, and permitted to adopt any grouping of information level, these information certification criteria. models would need to be harmonized • standards, implementation Section 3004(b)(1) of the PHSA specifications, or certification criteria. into a consistent representation. requires a one-time action by the On the other hand, if the Secretary In other cases, organizations may use Secretary to adopt an initial set of determines not to propose the adoption the same information model, but use standards, implementation of any grouping of standards, different vocabularies or code sets (for specifications, and certification criteria. implementation specifications, or example, Systematized Nomenclature of This interim final rule has been Medicine Clinical Terms (SNOMED certification criteria, the Secretary must ® published to meet the requirements in notify the National Coordinator and the CT ) or ICD9–CM) within those section 3004(b)(1). HIT Standards Committee in writing of information models. To achieve • Section 3004(a) of the PHSA defines such determination and the reasons for interoperability at this level, a process whereby an obligation is standardizing vocabularies, or mapping not proposing their adoption. imposed on the Secretary to review between different vocabularies (using standards, implementation The HIT Standards Committee issued tools like Unified Medical Language specifications, and certification criteria recommendations to the National System (UMLS)) may be necessary. For and identifies the procedures for the Coordinator on August 20, 2009, and some levels, (such as the network Secretary to follow to determine updated those recommendations on transport protocol), an industry whether to adopt any grouping of September 15, 2009. In fulfilling the standard that is widely used (e.g., standards, implementation duties under section 3001(c)(1)(A) and Transmission Control Protocol (TCP) specifications, or certification criteria (B), the National Coordinator reviewed and the Internet Protocol (IP), (TCP/IP)) included within National Coordinator- the recommendations made by the HIT will likely be the most appropriate. endorsed recommendations. The Standards Committee and issued a Ultimately, to achieve semantic specific elements of the process related determination endorsing several interoperability, we anticipate that to section 3004(a) will be described in recommendations for the Secretary’s multiple layers—network transportation greater detail below. consideration. As specified in section protocols, data and services • Section 3004(b)(3) of the PHSA 3004(a)(3), this interim final rule also descriptions, information models, and entitled ‘‘subsequent standards activity’’ serves as the Secretary’s formal vocabularies and code sets—will need states that the ‘‘Secretary shall adopt publication of the determinations made to be standardized and/or harmonized additional standards, implementation regarding the National Coordinator- to produce an inclusive, consistent specifications, and certification criteria endorsed recommendations. representation of the interoperability as necessary and consistent’’ with the D. Future Updates to Standards, requirements. We anticipate using a schedule published by the HIT Implementation Specifications, and harmonization process that will Standards Committee. While we intend Certification Criteria integrate different representations of to consistently seek the insights and health care information into a consistent recommendations of the HIT Standards The initial set of standards, representation and maintain and update Committee, we note that section implementation specifications, and that consistent representation over time. 3004(b)(3) provides the Secretary with certification criteria adopted in this For an information model, this process the authority and discretion to adopt interim final rule marks the beginning of could include merging related concepts, standards, implementation what we expect to be an iterative adding new concepts, and mapping specifications, and certification criteria approach to enhancing the concepts from one representation of without having first received a National interoperability, functionality, utility, health care information to another. Coordinator-endorsed HIT Standards and security of HIT. A number of factors Similar processes to support Committee recommendation. including maturity, prevalence in the standardization of data and services Under section 3004(a) when a market, and implementation complexity descriptions and vocabularies and codes recommendation regarding a standard, informed our adoption of the standards, sets may also be needed. implementation specification, or implementation specifications, and We also recognize that a sustainable certification criterion is made by the certification criteria included in this and incremental approach to the HIT Standards Committee to the interim final rule. adoption of standards will require

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processes for harmonizing both current hospitals that wish to position HIT are standards that are technical, and future standards. This will allow us themselves to achieve the requirements functional, or performance-based. For to incrementally update our initial set of of meaningful use Stage 1, once example, a technical standard could standards, implementation finalized, could adopt and implement specify that the structure of a message specifications, and certification criteria Certified EHR Technology. In drafting containing a patient’s blood test results and provide a framework to maintain this interim final rule, we considered must include a header, the type of test them. Our decision to adopt such the input of the National Committee on performed, and the results, and further, updates will be informed and guided by Vital and Health Statistics, the HIT that message must always be put in that recommendations from the HIT Policy Policy Committee, and the HIT sequence and be 128 bits long; a Committee, HIT Standards Committee, Standards Committee and the public functional standard could specify public comment, industry readiness, comments received by each committee. certain actions that must be consistently and future meaningful use goals and We invite public comment on this accomplished by HIT such as recording objectives established for the Medicare interim final rule and have posed the date and time when an electronic and Medicaid EHR Incentive Programs. several questions on topics for which prescription is transmitted; and a As a result, we expect, unless otherwise we are interested in receiving specific performance standard could specify necessary, to adopt standards, public comment. certain operational requirements for HIT implementation specifications, and such as being able to properly identify certification criteria synchronously with III. Section-By-Section Description of a drug-allergy contraindication 99.99% and to support a transition to the next the Interim Final Rule of the time for patient safety purposes. stage of meaningful use in the Medicare A. Applicability—§ 170.101 With this in mind, we have chosen to and Medicaid EHR Incentive Programs. define standard to mean: a technical, This part establishes the applicable In doing so, we also anticipate functional, or performance-based rule, standards, implementation increasing the level of specificity we condition, requirement, or specification specifications, and certification criteria provide related to standards, that stipulates instructions, fields, that must be used to test and certify implementation specifications, and codes, data, materials, characteristics, or HIT. certification criteria as well as phasing actions. out certain alternative standards that B. Definitions—§ 170.102 2. Definition of Implementation have been adopted in this initial set. Specification Furthermore, we anticipate that the 1. Definition of Standard requirements for meaningful use will The term standard is used in many The term implementation become more demanding over time, and different contexts and for many different specification is defined at 45 CFR consequently that Certified EHR purposes. The HITECH Act did not 160.103 of the HIPAA Rules as ‘‘specific Technology will need to include greater define or provide a description of the requirements or instructions for capabilities as well as the ability to term, standard, or how it should be used implementing a standard.’’ We believe exchange electronic health information in relation to HIT. As a result, we that this definition conveys accurately in a variety of circumstances with many looked to other sources to inform our the meaning of the term as used in the different types of health information definition for the term. HITECH Act, which seeks consistency technology. Finally, as will be discussed As specified in the HIPAA Rules, between these implementation in more detail in the HIT Certification standard is defined at 45 CFR 160.103 specifications and those adopted under Programs proposed rule, it is possible to mean ‘‘a rule, condition, or HIPAA. Moreover, the concept it applies that the certification programs requirement: (1) Describing the complements the definition of standard established by the National Coordinator following information for products, adopted in this interim final rule. could certify other types of HIT, perhaps systems, services or practices: (i) Additionally, this definition is related to certain specialty products and Classification of components. (ii) straightforward, easy to understand, and personal health records. In order for that Specification of materials, performance, is otherwise consistent with our goals. to occur, specific standards, or operations; or (iii) Delineation of We have therefore adopted the HIPAA implementation specifications, and procedures; or (2) With respect to the regulatory definition of implementation certification criteria related to those privacy of individually identifiable specification without modification. types of HIT would need to be health information.’’ This definition 3. Definition of Certification Criteria developed and adopted. includes important concepts that we believe are applicable and appropriate The term certification criteria is II. Overview of the Interim Final Rule for this interim final rule and we have described at section 3001(c)(5)(B) of the We are adding a new part, part 170, included these concepts in our PHSA to mean ‘‘with respect to to title 45 of the Code of Federal definition of standard. Other definitions standards and implementation Regulations (CFR) to adopt the initial set or descriptions of the term standard specifications for health information of standards, implementation include ‘‘an established policy on a technology, criteria to establish that the specifications, and certification criteria particular practice or method;’’ ‘‘a set of technology meets such standards and required by section 3004(b)(1) of the instructions for performing operations implementation specifications.’’ We PHSA. We describe the standards, or functions;’’ or ‘‘a published statement have incorporated this description into implementation specifications, and on a topic specifying the characteristics, our definition of certification criteria certification criteria adopted by the usually measurable, that must be described below and expanded it to also Secretary and the factors that satisfied or achieved to comply with the address how the term is used in various contributed to their adoption. We standard.’’ 2 parts of the HITECH Act. The definition anticipate that adopted standards, We believe the types of standards consequently encompasses more than implementation specifications, and envisioned by Congress in the HITECH just certification criteria that establish certification criteria will be used to Act that would be most applicable to technology meets ‘‘standards and prepare Complete EHRs and EHR implementation specifications.’’ In Modules for testing and certification. In 2 This last definition is referenced in Federal support of meaningful use, for instance, turn, eligible professionals and eligible Information Processing Standards 201. there are many other capabilities

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Certified EHR Technology will need to definition of Qualified EHR without by the Secretary and distinguish it from provide under the HITECH Act even modification. EHR technology that cannot perform though such capabilities do not require those capabilities. We fully expect some 5. Definition of EHR Module a particular standard or implementation Complete EHRs to have capabilities specification. As a result, we believe We have defined the term EHR beyond those addressed by certification that it is critical for these capabilities to Module to mean any service, criteria adopted by the Secretary. be tested and certified too. To do component, or combination thereof that 7. Definition of Certified EHR otherwise would potentially make it can meet the requirements of at least Technology difficult for eligible professionals and one certification criterion adopted by eligible hospitals to know whether the the Secretary. Examples of EHR Certified EHR Technology is defined Certified EHR Technology they have Modules include, but are not limited to, at section 3000(1) of the PHSA as ‘‘a adopted and implemented will support the following: qualified electronic health record that is their achievement of meaningful use. • An interface or other software certified pursuant to section 3001(c)(5) For example, if we did not require a program that provides the capability to as meeting standards adopted under certification criterion for medication exchange electronic health information; section 3004 that are applicable to the reconciliation, a proposed meaningful • An open source software program type of record involved.’’ In this interim use Stage 1 objective, Certified EHR that enables individuals online access to final rule, we have slightly revised the Technology under this scenario would certain health information maintained definition of Certified EHR Technology not provide any assurance to an eligible by EHR technology; to make it more consistent with the • professional or eligible hospital that the A clinical decision support rules initial standards, implementation proposed meaningful use Stage 1 engine; specifications, and certification criteria • requirement could be met. On the other A software program used to submit that are being adopted. Certification hand, by adopting a certification public health information to public criteria focus on the capabilities of health authorities; and Complete EHRs or EHR Modules and criterion for medication reconciliation • in this interim final rule, eligible A quality measure reporting service consequently, Certified EHR Technology professionals and eligible hospitals can or software program. should be defined in accordance with be assured that once they adopt and While the use of EHR Modules may that approach. We believe defining implement Certified EHR Technology, it enable an eligible professional or Certified EHR Technology in that includes, at a minimum, the medication eligible hospital to create a combination manner will provide greater clarity and reconciliation capabilities required to of products and services that, taken meaning for this interim final rule. support their achievement of the together, meets the definition of We have defined Certified EHR proposed meaningful use Stage 1 Certified EHR Technology, this Technology to mean: requirement. approach carries with it a responsibility A Complete EHR or a combination of For these reasons we have defined the on the part of the eligible professional EHR Modules, each of which: term certification criteria to encompass or eligible hospital to perform (1) Meets the requirements included both the statutory description and the additional diligence to ensure that the in the definition of a Qualified EHR; and statutory use of the term. The definition certified EHR Modules selected are (2) has been tested and certified in consequently also includes other capable of working together to support accordance with the certification certification criteria that are not directly the achievement of meaningful use. In program established by the National tied to establishing that health other words, two certified EHR Modules Coordinator as having met all applicable information technology has met a may provide the additional capabilities certification criteria adopted by the standard or implementation necessary to meet the definition of Secretary. specification. We have therefore defined Certified EHR Technology, but may not To clarify the meaning of ‘‘applicable certification criteria to mean: criteria: (1) integrate well with each other or with certification criteria’’ in this definition’s To establish that health information the other EHR technology they were second part, we note that Congress technology meets applicable standards added to. As a result, eligible indicated their expectation that different and implementation specifications professionals and eligible hospitals that types of HIT would be certified. adopted by the Secretary; or (2) that are elect to adopt and implement certified Congress elaborated on this expectation used to test and certify that health EHR Modules should take care to ensure with a parenthetical in the statutory information technology includes that the certified EHR Modules they definition, which references two required capabilities. select are interoperable and can examples, ‘‘an ambulatory electronic properly perform in their expected health record for office-based 4. Definition of Qualified Electronic operational environment. physicians’’ and ‘‘an inpatient hospital Health Record (EHR) electronic health record for hospitals.’’ Qualified EHR is defined at section 6. Definition of Complete EHR For a variety of reasons, including that 3000(13) of the PHSA as ‘‘an electronic The term Complete EHR is used to certain proposed meaningful use Stage 1 record of health-related information on mean EHR technology that has been objectives only apply to an eligible an individual that: (A) Includes patient developed to meet all applicable professional or eligible hospital and that demographic and clinical health certification criteria adopted by the these two types of health care providers information, such as medical history Secretary. We believe this definition require different capabilities from and problem lists; and (B) has the helps to create a clear distinction Certified EHR Technology, we have capacity: (i) To provide clinical decision between a Complete EHR, an EHR adopted specific certification criteria support; (ii) to support physician order Module, and Certified EHR Technology. that are only ‘‘applicable’’ to Complete entry; (iii) to capture and query The term Complete EHR is not meant to EHRs or EHR Modules designed for use information relevant to health care limit the capabilities that a Complete in an ambulatory setting (e.g., by eligible quality; and (iv) to exchange electronic EHR can include. Rather, it is meant to professionals) or an inpatient setting health information with, and integrate encompass EHR technology that can (e.g., by eligible hospitals). We indicate such information from other sources.’’ perform all of the applicable capabilities in Table 1, and in the regulation text We have adopted the statutory required by certification criteria adopted below, which certification criteria apply

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solely to Complete EHRs or EHR whose purpose is to enable the It is important to note that the Modules designed for use in an electronic exchange of health capabilities included in the definition of ambulatory setting or an inpatient information. As another example, a Qualified EHR set the floor for the setting. For example, we do not expect subscription to an application service capabilities that Certified EHR Certified EHR Technology that is provider (ASP) for electronic Technology must include. For example, adopted and implemented by an eligible prescribing could be an EHR Module the definition of Qualified EHR does not professional to include the capability to and used to help meet the definition of require capabilities related to privacy create an electronic copy of discharge Certified EHR Technology provided that and security; however, the Secretary has instructions. We do, however, expect the electronic prescribing capability the adopted certification criteria for privacy Certified EHR Technology that is ASP enables has been tested and and security. Therefore, where the adopted and implemented by an eligible certified. Secretary has adopted certification hospital to include this capability. As long as each EHR Module has been criteria that require capabilities beyond We believe that by adding the word separately tested and certified in those specified in the definition of a ‘‘technology’’ after ‘‘EHR,’’ Congress accordance with the certification Qualified EHR, a Complete EHR or EHR intended to convey an expectation that program established by the National Module will need to be tested and rather than adopt a complete, all-in-one Coordinator (which will be discussed in certified to those adopted certification solution, eligible professionals and a future rulemaking) to all of the criteria in order for the definition of eligible hospitals would likely adopt applicable certification criteria adopted Certified EHR Technology to be met. and implement some number of by the Secretary, a proper combination technological components or EHR of certified EHR Modules could meet 8. Definition of Disclosure Modules to extend the useful life of the definition of Certified EHR We define disclosure in this interim their legacy EHR technology or other Technology. To clarify, we are not final rule to have the same meaning HIT that may not provide all of the requiring the certification of specified at 45 CFR 160.103—‘‘the capabilities necessary to achieve combinations of certified EHR Modules, release, transfer, provision of access to, meaningful use. just that the individual EHR Modules or divulging in any other manner of In the early stages of the Medicare and combined have each been certified to all information outside the entity holding Medicaid EHR Incentive Programs, we applicable certification criteria in order the information.’’ As previously expect most eligible professionals and for such a ‘‘combination’’ to meet the mentioned, once the Secretary adopts a many eligible hospitals to opt for a definition of Certified EHR Technology. standard on accounting for disclosures Complete EHR that has met the The following are examples of described in section 3002(b)(2)(B)(iv) of definition of Certified EHR Technology. Certified EHR Technology: the PHSA, the Secretary through the However, with the future in mind, and • A complete EHR that is tested and HHS Office for Civil Rights, is required to address those eligible providers and certified to all applicable certification to modify (no later than 6 months after eligible hospitals that may decide to criteria. the date on which the Secretary adopts implement their own Complete EHRs or • The combination of three certified standards on accounting for disclosures) EHR Modules, we have adopted a EHR modules that include all of the the HIPAA Privacy Rule at 45 CFR definition of Certified EHR Technology capabilities required by all applicable 164.528 to require that HIPAA covered that we believe is flexible enough to certification criteria. (We note that in entities account for disclosures related account for innovations in an industry this circumstance it is the user’s to treatment, payment, and health care that continues to rapidly evolve. responsibility to determine whether the operations made through an electronic Additionally, we believe this definition combination of these three certified EHR health record and to identify in the of Certified EHR Technology will lead to Modules would meet all of the regulations the information that shall be a more competitive marketplace and applicable certification criteria collected about each of the disclosures. allow those who adopt HIT to choose necessary to meet the definition of C. Initial Set of Standards, from a variety of offerings ranging from Certified EHR Technology.) Implementation Specifications, and subscription services, to vendor-based The following are examples of what Certification Criteria §§ 170.202, products, to open source products. An would not meet the definition of 170.205, 170.210, 170.302, 170.304, innovative and competitive HIT Certified EHR Technology: 170.306 marketplace needs to exist much like • Complete EHRs that have not been the marketplace for consumer tested and certified in accordance with The sections below describe the electronics, where, for the purpose of the certification program established by initial set of standards, implementation setting up a home theater, a television, the National Coordinator even though it specifications, and certification criteria DVD player, and stereo system can be may be claimed that such technology adopted by the Secretary to support, in purchased from three different provides the same capabilities as those part, the achievement of meaningful use manufacturers, from a single required by adopted certification Stage 1 (which begins in 2011). The manufacturer, or as a complete system criteria. standards, implementation from one manufacturer. • The combination of three certified specifications, and certification criteria To that end, we believe that it will be EHR modules that do not include all of adopted are meant to serve as the basis common in the near future for Certified the capabilities required by all for the testing and certification of EHR Technology to be assembled from applicable certification criteria. That is, Complete EHRs and EHR Modules and several replaceable and swappable EHR if these three certified EHR modules they should in no way be misconstrued Modules. For example, an EHR Module were purchased by an eligible as additional detailed requirements for specifically designed to enable professional and none of them included meaningful use Stage 1 itself. In order electronic health information exchange the capability to electronically to prevent confusion, we believe it is may be implemented for the purposes of prescribe, the combination of these necessary to make clear that the interoperability and participation in a three modules would not be a proper standards, implementation health information organization, combination of certified EHR Modules specifications, and certification criteria regional health information and would not meet the definition of adopted by the Secretary in this interim organization, or some other consortium Certified EHR Technology. final rule apply to, and establish the

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required capabilities for, Certified EHR meaningful use and the certification of Programs proposed rule to identify the Technology. These criteria do not HIT, which the National Coordinator initial set of certification criteria establish requirements for health care has considered. For the purposes of this adopted in this interim final rule and providers, such as eligible professionals interim final rule and the adoption of an have linked the certification criteria to or eligible hospitals to follow. Because initial set of certification criteria, we these objectives. certification criteria describe both the believe that the meaningful use matrix Many of the proposed meaningful use required capabilities Certified EHR recommended by the HIT Policy Stage 1 objectives are exactly the same Technology must include and, where Committee as modified in the Medicare for eligible professionals and eligible applicable, the standard(s) that must be and Medicaid EHR Incentive Programs hospitals. Where proposed meaningful used by those capabilities, we discuss proposed rule provides a logical way to use Stage 1 objectives were identical for adopted certification criteria first. Table structure our presentation of adopted eligible professionals and eligible 1 below displays the certification certification criteria. Furthermore, we hospitals, we adopted identical criteria we have adopted. Next we found the following recommendations certification criteria for Complete EHRs discuss adopted standards and the on certification from the HIT Policy or EHR Modules. However, there are purposes for their use. Tables 2A and 2B Committee to be particularly instances where proposed meaningful include the standards referenced by informative for the scope of this interim use Stage 1 objective and corresponding adopted certification criteria for a final rule and our approach to adopting meaningful use measure are specifically particular exchange or privacy or certification criteria—that certification aimed at an eligible professional (e.g., security purpose. Lastly we discuss our should focus on meaningful use and be electronic prescribing) or eligible approach to implementation leveraged to improve security, privacy, hospital (e.g., provision of an electronic specifications. and interoperability. We agree that for copy of discharge instructions). Where To guide our approach to adopting the this initial set of certification criteria, the proposed meaningful use Stage 1 standards, implementation supporting the achievement of objectives were worded differently or specifications, and certification criteria meaningful use Stage 1, as proposed in only applied to an eligible professional below, we established the following the Medicare and Medicaid EHR or eligible hospital, we have adopted goals: Incentive Programs proposed rule, is a specific certification criteria to assure • Promote interoperability and where foremost priority. As a result, we have that Certified EHR Technology includes necessary be specific about certain adopted, based in part on the HIT Policy the capabilities necessary to meet that content exchange and vocabulary Committee’s recommendation, an initial objective. standards to establish a path forward set of certification criteria to support the Additionally, CMS describes in the toward semantic interoperability; achievement by eligible professionals Medicare and Medicaid EHR Incentive • Support the evolution and timely and eligible hospitals of meaningful use Programs proposed rule a number of the maintenance of adopted standards; Stage 1, as proposed in the Medicare terms referenced in this table, • Promote technical innovation using and Medicaid EHR Incentive Programs specifically those in the first column adopted standards; proposed rule. which align directly with the proposed • Encourage participation and The meaningful use matrix meaningful use Stage 1 objectives. For adoption by all vendors, including small recommended by the HIT Policy example, one of the proposed businesses; Committee, a revised form of which meaningful use Stage 1 objectives is to • Keep implementation costs as low CMS has included in the Medicare and ‘‘perform medication reconciliation at as reasonably possible; Medicaid EHR Incentive Programs relevant encounters and each transition • Consider best practices, proposed rule, includes overall health of care.’’ We have adopted a certification experiences, policies, frameworks, and outcome policy priorities and health criterion to assure that a Complete EHR the input of the HIT Policy Committee care goals that are the same for eligible or EHR Module is capable of performing and HIT Standards Committee in professionals and eligible hospitals. The medication reconciliation. However, it current and future standards; health outcome policy priorities is not within the scope of this interim • Enable mechanisms such as the identified in the Medicare and Medicaid final rule to specify when or how often NHIN to serve as a test-bed for EHR Incentive Programs proposed rule this needs to occur. Rather, the innovation and as an open-source are: ‘‘Improving quality, safety, proposed meaningful use Stage 1 reference implementation of best efficiency, and reducing health measure for this proposed objective practices; and disparities; engage patients and families dictates the frequency, and the preamble • To the extent possible, adopt in their health care; improve care of the Medicare and Medicaid EHR standards that are modular and not coordination; improve population and Incentive Programs proposed rule interdependent. For example, an public health; and ensure adequate provides descriptions for what is meant adopted vocabulary standard would not privacy and security protections for by ‘‘relevant encounters’’ and ‘‘each be tied to a particular content exchange personal health information.’’ For each transition of care.’’ We encourage any standard (e.g., the adoption of Current policy priority, there are also associated reader seeking the meaning or further Procedural Terminology (CPT®) Fourth health care goals which are described in explanation of a particular term in the Edition (CPT–4) codes would not more detail in the Medicare and objectives to review the Medicare and require or preclude the use of a Medicaid EHR Incentive Programs Medicaid EHR Incentive Programs particular patient summary record proposed rule. proposed rule. standard such as the continuity of care The health care goals served as the To improve the readability of Table 1 document (CCD) or continuity of care bases for the proposed specific and illustrate the linkage between record (CCR)). meaningful use Stage 1 objectives for adopted certification criteria and eligible professionals and eligible proposed meaningful use Stage 1 1. Adopted Certification Criteria hospitals set forth in the Medicare and objectives, in instances where the At its July 16, 2009 and August 14, Medicaid EHR Incentive Programs proposed meaningful use Stage 1 2009 meetings, the HIT Policy proposed rule. We have consequently objective was the same in concept for Committee made recommendations to used the proposed objectives in the eligible professionals and eligible the National Coordinator on policies for Medicare and Medicaid EHR Incentive hospitals but differed slightly with

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respect to wording, we provided a be updated from an older, ‘‘minimum,’’ adopted through incorporation by combined objective and referenced the adopted version of a code set to a more reference is modified significantly, we full proposed objective in a footnote. All current version without adversely will update the incorporation by certification criteria are prefaced with affecting Certified EHR Technology’s reference of the adopted version with the statement ‘‘A Complete EHR or EHR ‘‘certified status.’’ We intend to elaborate the more recent version of the code set Module must include the capability to:’’ in the upcoming HIT Certification prior to requiring or permitting in order to create uniformity in the way Programs proposed rule on how testing certification according to the newer each certification criterion is read. and certification would be conducted version. Finally, we understand that certain using standards we have adopted and The following provides an example of types of standards, specifically code designated as ‘‘minimums’’ in certain sets, must be maintained and frequently certification criteria. how our approach will work. A updated to serve their intended purpose Because we expect to adopt additional proposed meaningful use Stage 1 effectively. Code sets are typically used code set standards in the future, we objective specifies the capability to for encoding data elements, such as believe this approach is necessary. submit electronic data to immunization medical terms, medical concepts, Moreover, we believe the certification of registries and, accordingly, we have diagnoses, and medical procedures. As Complete EHRs and EHR Modules adopted a certification criterion to new medical procedures, technologies, should be flexible enough to assure that a Complete EHR or EHR treatments, or diagnostic methods are accommodate current code sets that are Module is capable of electronically developed or discovered, additional regularly maintained and updated. We recording, retrieving, and transmitting codes must be added or existing codes also believe that this approach will immunization information to must be revised. In some cases, new enable and encourage eligible immunization registries in accordance codes are necessary to reflect the most professionals and eligible hospitals to with the standards specified in Table 2A recent changes in medical practice, adopt Certified EHR Technology and row 8. Table 2A row 8 references, as a involving perhaps revised medication keep it current, which will promote vocabulary standard (code set), the CDC dosage, updated treatment procedures, patient safety, public health safety, and maintained HL7 standard code set CVX- or the discovery of new diseases. In more broadly, improve health care Vaccines Administered. The current many cases, the new codes must be quality. version of the CVX code set was disseminated and implemented quickly That being said, we understand that published July 30, 2009, and includes for patient safety and significant public this approach has certain limitations. In new vaccine codes related to the ‘‘Novel health purposes. some cases, for instance, rather than Influenza-H1N1.’’ Continuing our CVX To address this need and simply maintaining, correcting, or example, if the CDC were to publish a accommodate industry practice, we slightly revising a code set, a code set new version of CVX on February 1, have in this interim final rule indicated maintaining organization will modify 2010, we would permit a Complete EHR that certain types of standards will be the structure or framework of a code set or EHR Module to be tested and considered a floor for certification. We to meet developing industry needs. We certified according to the minimum have implemented this approach by would consider this type of significant adopted version of the standard, the July preceding references to specific adopted revision to a code set to be a 30, 2009, version of CVX or the standards with the phrase, ‘‘at a ‘‘modification,’’ rather than maintenance February 1, 2010 version that was minimum.’’ In those instances, the or a minor update of the code set. An subsequently issued as part of the code certification criterion requires example of a code set ‘‘modification’’ compliance with the version of the code would be if a hypothetical XYZ code set set’s maintenance. set that has been adopted through version 1 were to use 7-digit numeric For certain certification criteria in incorporation by reference, or any codes to represent health information Table 1 below, we include a percent subsequently released version of the while XYZ code set version 2 used 9- symbol ‘‘%’’ superscript to indicate code set. This approach will permit digit alphanumeric codes to represent instances where the version of an Complete EHRs and EHR Modules to be health information. In such cases, adopted standard (specified in the tested and certified, to, ‘‘at a minimum,’’ interoperability would likely be reduced regulation text) will be ‘‘at a minimum’’ the version of the standard that has been among Complete EHRs and EHR the version to which a Complete EHR or adopted or a more current or Modules that have adopted different EHR Module must be tested and subsequently released version. This will versions of the structurally divergent certified in order to be considered also enable Certified EHR Technology to code sets. If a code set that we have compliant with the adopted standard.

TABLE 1—CERTIFICATION CRITERIA

Certification criteria to support the Certification criteria to support the Proposed meaningful use Stage 1 objectives achievement of meaningful use Stage 1 by eli- achievement of meaningful use Stage 1 by eli- gible professionals gible hospital

A Complete EHR or EHR Module must include the capability to:

Use Computerized Provider Order Entry Enable a user to electronically record, store, Enable a user to electronically record, store, (CPOE) 3. retrieve, and manage, at a minimum, the retrieve, and manage, at a minimum, the following order types: following order types: 1. Medications; 1. Medications; 2. Laboratory; 2. Laboratory; 3. Radiology/imaging; and 3. Radiology/imaging;

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TABLE 1—CERTIFICATION CRITERIA—Continued

Certification criteria to support the Certification criteria to support the Proposed meaningful use Stage 1 objectives achievement of meaningful use Stage 1 by eli- achievement of meaningful use Stage 1 by eli- gible professionals gible hospital

4. Provider referrals. 4. Blood bank; 5. Physical therapy; 6. Occupational therapy; 7. Respiratory therapy; 8. Rehabilitation therapy; 9. Dialysis; 10. Provider consults; and 11. Discharge and transfer.

Implement drug-drug, drug-allergy, drug-for- 1. Automatically and electronically generate and indicate (e.g., pop-up message or sound) in mulary checks. real-time, alerts at the point of care for drug-drug and drug-allergy contraindications based on medication list, medication allergy list, age, and CPOE. 2. Enable a user to electronically check if drugs are in a formulary or preferred drug list in ac- cordance with the standard specified in Table 2A row 2. 3. Provide certain users with administrator rights to deactivate, modify, and add rules for drug- drug and drug-allergy checking. 4. Automatically and electronically track, record, and generate reports on the number of alerts responded to by a user. Maintain an up-to-date problem list of current Enable a user to electronically record, modify, and retrieve a patient’s problem list for longitu- and active diagnoses based on ICD–9–CM dinal care (i.e., over multiple office visits) in accordance with the applicable standards% speci- or SNOMED CT®. fied in Table 2A row 1.

Generate and transmit permissible prescrip- Enable a user to electronically transmit medi- No Associated Proposed Meaningful Use tions electronically (eRx). cation orders (prescriptions) for patients in Stage 1 Objective. accordance with the standards specified in Table 2A row 3.

Maintain active medication list ...... Enable a user to electronically record, modify, and retrieve a patient’s active medication list as well as medication history for longitudinal care (i.e., over multiple office visits) in accordance with the applicable standard specified in Table 2A row 1.

Maintain active medication allergy list ...... Enable a user to electronically record, modify, and retrieve a patient’s active medication allergy list as well as medication allergy history for longitudinal care (i.e., over multiple office visits).

Record demographics 45 ...... Enable a user to electronically record, modify, Enable a user to electronically record, modify, and retrieve patient demographic data in- and retrieve patient demographic data in- cluding preferred language, insurance type, cluding preferred language, insurance type, gender, race, ethnicity, and date of birth. gender, race, ethnicity, date of birth, and date and cause of death in the event of mortality.

Record and chart changes in vital signs: 1. Enable a user to electronically record, modify, and retrieve a patient’s vital signs including, at • Height a minimum, the height, weight, blood pressure, temperature, and pulse. • Weight 2. Automatically calculate and display body mass index (BMI) based on a patient’s height and • Blood pressure weight. • Calculate and display: BMI 3. Plot and electronically display, upon request, growth charts (height, weight, and BMI) for pa- • Plot and display growth charts for chil- tients 2–20 years old. dren 2–20 years, including BMI. Record smoking status for patients 13 years Enable a user to electronically record, modify, and retrieve the smoking status of a patient to: old or older. current smoker, former smoker, or never smoked. Incorporate clinical lab-test results into EHR as 1. Electronically receive clinical laboratory test results in a structured format and display such structured data. results in human readable format. 2. Electronically display in human readable format any clinical laboratory tests that have been received with LOINC® codes. 3. Electronically display all the information for a test report specified at 42 CFR 493.1291(c)(1) through (7).6 4. Enable a user to electronically update a patient’s record based upon received laboratory test results. Generate lists of patients by specific conditions Enable a user to electronically select, sort, retrieve, and output a list of patients and patients’ to use for quality improvement, reduction of clinical information, based on user-defined demographic data, medication list, and specific con- disparities, and outreach. ditions. Report quality measures to CMS or the 1. Calculate and electronically display quality measure results as specified by CMS or states. States 78. 2. Enable a user to electronically submit calculated quality measures in accordance with the standard specified in Table 2A row 5.

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TABLE 1—CERTIFICATION CRITERIA—Continued

Certification criteria to support the Certification criteria to support the Proposed meaningful use Stage 1 objectives achievement of meaningful use Stage 1 by eli- achievement of meaningful use Stage 1 by eli- gible professionals gible hospital

Send reminders to patients per patient pref- Electronically generate, upon request, a pa- No Associated Proposed Meaningful Use erence for preventive/follow up care. tient reminder list for preventive or follow-up Stage 1 Objective. care according to patient preferences based on demographic data, specific conditions, and/or medication list.

Implement 5 clinical decision support rules 910 1. Implement automated, electronic clinical de- 1. Implement automated, electronic clinical de- cision support rules (in addition to drug-drug cision support rules (in addition to drug-drug and drug-allergy contraindication checking) and drug-allergy contraindication checking) according to specialty or clinical priorities according to a high priority hospital condi- that use demographic data, specific patient tion that use demographic data, specific pa- diagnoses, conditions, diagnostic test re- tient diagnoses, conditions, diagnostic test sults and/or patient medication list. results and/or patient medication list. 2. Automatically and electronically generate 2. Automatically and electronically generate and indicate (e.g., pop-up message or and indicate (e.g., pop-up message or sound) in real-time, alerts and care sugges- sound) in real-time, alerts and care sugges- tions based upon clinical decision support tions based upon clinical decision support rules and evidence grade. rules and evidence grade. 3. Automatically and electronically track, 3. Automatically and electronically track, record, and generate reports on the number record, and generate reports on the number of alerts responded to by a user. of alerts responded to by a user.

Check insurance eligibility electronically from Enable a user to electronically record and display patients’ insurance eligibility, and submit in- public and private payers. surance eligibility queries to public or private payers and receive an eligibility response in ac- cordance with the applicable standards specified in Table 2A row 4. Submit claims electronically to public and pri- Enable a user to electronically submit claims to public or private payers in accordance with the vate payers. applicable standards specified in Table 2A row 4.

Provide patients with an electronic copy of their Enable a user to create an electronic copy of Enable a user to create an electronic copy of health information upon request 11 12. a patient’s clinical information, including, at a patient’s clinical information, including, at a minimum, diagnostic test results, problem a minimum, diagnostic test results, problem list, medication list, medication allergy list, list, medication list, medication allergy list, immunizations, and procedures in: (1) immunizations, discharge summary, and Human readable format; and (2) accord- procedures in: (1) Human readable format; ance with the standards% specified in Table and (2) accordance with the standards% 2A row 1 to provide to a patient on elec- specified in Table 2A row 1 to provide to a tronic media, or through some other elec- patient on electronic media, or through tronic means. some other electronic means. Provide patients with an electronic copy of their No Associated Proposed Meaningful Use Enable a user to create an electronic copy of discharge instructions and procedures at Stage 1 Objective. the discharge instructions and procedures time of discharge, upon request. for a patient, in human readable format, at the time of discharge to provide to a patient on electronic media, or through some other electronic means. Provide patients with timely electronic access Enable a user to provide patients with online No Associated Proposed Meaningful Use to their health information (including lab re- access to their clinical information, includ- Stage 1 Objective. sults, problem list, medication lists, allergies) ing, at a minimum, lab test results, problem within 96 hours of the information being list, medication list, medication allergy list, available to the eligible professional. immunizations, and procedures. Provide clinical summaries for patients for each 1. Enable a user to provide clinical summaries No Associated Proposed Meaningful Use office visit. to patients (in paper or electronic form) for Stage 1 Objective. each office visit that include, at a minimum, diagnostic test results, medication list, medi- cation allergy list, procedures, problem list, and immunizations. 2. If the clinical summary is provided electroni- cally (i.e., not printed), it must be provided in: (1) Human readable format; and (2) ac- cordance with the standards% specified in Table 2A row 1 to provide to a patient on electronic media, or through some other electronic means.

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TABLE 1—CERTIFICATION CRITERIA—Continued

Certification criteria to support the Certification criteria to support the Proposed meaningful use Stage 1 objectives achievement of meaningful use Stage 1 by eli- achievement of meaningful use Stage 1 by eli- gible professionals gible hospital

Capability to exchange key clinical information 1. Electronically receive a patient summary 1. Electronically receive a patient summary among providers of care and patient author- record, from other providers and organiza- record, from other providers and organiza- ized entities electronically 13 14. tions including, at a minimum, diagnostic tions including, at a minimum, discharge Provide summary care record for each transi- test results, problem list, medication list, summary, diagnostic test results, problem tion of care and referral. medication allergy list, immunizations, and list, medication list, medication allergy list, procedures and upon receipt of a patient immunizations, and procedures and upon summary record formatted in an alternative receipt of a patient summary record for- standard specified in Table 2A row 1, dis- matted in an alternative standard specified playing it in human readable format. in Table 2A row 1, displaying it in human 2. Enable a user to electronically transmit a readable format. patient summary record to other providers 2. Enable a user to electronically transmit a and organizations including, at a minimum, patient summary record, to other providers diagnostic test results, problem list, medica- and organizations including, at a minimum, tion list, medication allergy list, immuniza- discharge summary, diagnostic test results, tions, and procedures in accordance with problem list, medication list, medication al- the standards% specified in Table 2A row 1. lergy list, immunizations, and procedures in accordance with the standards% specified in Table 2A row 1.

Perform medication reconciliation at relevant Electronically complete medication reconciliation of two or more medication lists (compare and encounters and each transition of care. merge) into a single medication list that can be electronically displayed in real-time. Capability to submit electronic data to immuni- Electronically record, retrieve, and transmit immunization information to immunization registries zation registries and actual submission in accordance with the standards% specified in Table 2A row 8 or in accordance with the appli- where required and accepted. cable state-designated standard format.

Capability to provide electronic submission of No Associated Proposed Meaningful Use Electronically record, retrieve, and transmit re- reportable lab results (as required by state or Stage 1 Objective. portable clinical lab results to public health local law) to public health agencies and ac- agencies in accordance with the standards% tual submission where it can be received. specified in Table 2A row 6.

Capability to provide electronic syndromic sur- Electronically record, retrieve, and transmit syndrome-based (e.g., influenza like illness) public veillance data to public health agencies and health surveillance information to public health agencies in accordance with the standards actual transmission according to applicable specified in Table 2A row 7. law and practice. Protect electronic health information created or 1. Assign a unique name and/or number for identifying and tracking user identity and establish maintained by the certified EHR technology controls that permit only authorized users to access electronic health information. through the implementation of appropriate 2. Permit authorized users (who are authorized for emergency situations) to access electronic technical capabilities. health information during an emergency. 3. Terminate an electronic session after a predetermined time of inactivity. 4. Encrypt and decrypt electronic health information according to user-defined preferences (e.g., backups, removable media, at log-on/off) in accordance with the standard specified in Table 2B row 1. 5. Encrypt and decrypt electronic health information when exchanged in accordance with the standard specified in Table 2B row 2. 6. Record actions (e.g., deletion) related to electronic health information in accordance with the standard specified in Table 2B row 3 (i.e., audit log), provide alerts based on user-defined events, and electronically display and print all or a specified set of recorded information upon request or at a set period of time. 7. Verify that electronic health information has not been altered in transit and detect the alter- ation and deletion of electronic health information and audit logs in accordance with the stand- ard specified in Table 2B row 4. 8. Verify that a person or entity seeking access to electronic health information is the one claimed and is authorized to access such information. 9. Verify that a person or entity seeking access to electronic health information across a net- work is the one claimed and is authorized to access such information in accordance with the standard specified in Table 2B row 5. 10. Record disclosures made for treatment, payment, and health care operations in accordance with the standard specified in Table 2B row 6.

We reiterate that adopted certification Module must be capable of plotting and criteria identify the required capabilities displaying growth charts for patients. By demographics: preferred language, insurance type, for a Complete EHR or EHR Module to gender, race, ethnicity, date of birth.’’ 5 For eligible hospitals the full proposed be certified. Adopted certification 3 For eligible hospitals the full proposed meaningful use Stage 1 objective is: ‘‘record meaningful use Stage 1 objective is: ‘‘Use CPOE for criteria do not apply to, or require demographics: preferred language, insurance type, actions by, eligible professionals or orders (any type) directly entered by authorizing provider (for example, MD, DO, RN, PA, NP).’’ gender, race, ethnicity, date of birth, date and cause of death in the event of mortality.’’ eligible hospitals. For example, to be 4 For eligible professionals the full proposed 6 certified, a Complete EHR or EHR meaningful use Stage 1 objective is: ‘‘record 42 CFR 493.1291(b) specifies that ‘‘[t]he test report information maintained as part of the

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being tested and certified, a Complete assurance that the technology will the recommendation of the HIT EHR or EHR Module will have effectively support the delivery of Standards Committee, we have limited demonstrated that this capability is health care as well as the achievement the adoption of specific vocabulary available for an eligible professional or of meaningful use Stage 1, once standards in this initial set to a few, eligible hospital to use. finalized. important instances. In adopting these certification criteria, Presently, we have only adopted a we attempted to balance specificity with 2. Adopted Standards limited number of certification criteria flexibility and the opportunity for In fulfilling the Secretary’s that require Certified EHR Technology innovation. However, in taking this responsibility under section 3004(b)(1), to be capable of using a specific approach we recognize that certain the following initial set of standards and vocabulary or code set. In certain tradeoffs exist. On one hand, we implementation specifications have instances, because of other HHS anticipate that flexibility will allow been adopted 15 for use in Certified EHR regulatory requirements, we have Complete EHRs and EHR Modules to Technology to support proposed adopted those vocabularies and code evolve over time to meet these criteria meaningful use Stage 1 and to enable sets with which the regulated in increasingly efficient, useable, and increased interoperability and privacy community is already required to innovative ways. On the other hand, any and security. We have organized comply. We expect future stages of lack of specificity concerning the adopted standards into the same four meaningful use will require Certified capabilities Complete EHRs or EHR categories recommended by the HIT EHR Technology to provide additional Modules must include risks the Standards Committee. capabilities as well as an increased possibility that Certified EHR • Vocabulary Standards (i.e., capacity to exchange electronic health Technology may inadequately support standardized nomenclatures and code information according to specific an eligible professional or eligible sets used to describe clinical problems vocabularies and code sets. To enhance hospital’s attempt to achieve meaningful and procedures, medications, and interoperability, we believe it will be use Stage 1, once finalized. Therefore, allergies); essential to adopt specific standards, • we request public comment on whether Content Exchange Standards (i.e., vocabularies, and code sets in the any of the adopted certification criteria standards used to share clinical future. We look forward to receiving above are insufficiently specific to be information such as clinical summaries, recommendations from the HIT used to test and certify Complete EHRs prescriptions, and structured electronic Standards Committee related to specific or EHR Modules with reasonable documents); vocabularies and code sets to support • Transport Standards (i.e., standards future stages of meaningful use. patient’s chart or medical record must be readily used to establish a common, The initial set of standards and available to the laboratory and to CMS or a CMS predictable, secure communication implementation specifications in this agent upon request.’’ 42 CFR 493.1291(c) specifies protocol between systems); and interim final rule was adopted to the required test report information. • Privacy and Security Standards support the proposed requirements for 7 For eligible professionals the full proposed (e.g., authentication, access control, meaningful use Stage 1 objective is ‘‘Report meaningful use Stage 1. We have added ambulatory quality measures to CMS or the States.’’ transmission security) which relate to a column in Table 2A to illustrate the 8 For eligible hospitals the full proposed and span across all of the other types of standards that we believe Certified EHR meaningful use Stage 1 objective is ‘‘Report hospital standards. Technology should most likely be ’’ quality measures to CMS or the States. As demonstrated by the adopted capable of to support meaningful use 9 For eligible professionals the full proposed certification criteria, we expect Certified meaningful use Stage 1 objective is ‘‘Implement 5 Stage 2 (although as explained in the clinical decision support rules relevant to specialty EHR Technology to be tested and Medicare and Medicaid EHR Incentives or high clinical priority, including diagnostic test certified as being capable of complying Program proposed rule, CMS intends to ordering, along with the ability to track compliance with adopted standards. We note that engage in rulemaking to adopt Stage 2 with those rules’’ there are not standards required for criteria for meaningful use and ONC 10 For eligible hospitals the full proposed every certification criterion adopted by meaningful use Stage 1 objective is ‘‘Implement 5 would adopt standards consistent with clinical decision support rules related to a high this interim final rule. However, we this effort). We developed this list of priority hospital condition, including diagnostic have required standards as part of candidate Stage 2 standards by test ordering, along with the ability to track certain certification criteria when their considering the recommendations made compliance with those rules’’ adoption could lead to increased 11 For eligible professionals the full proposed by the HIT Standards Committee related meaningful use Stage 1 objective is ‘‘Provide interoperability and privacy and to standards to support meaningful use patients with an electronic copy of their health security. We agree with the HIT Policy Stage 2 and developing our own information (including diagnostic test results, Committee’s recommendation to focus estimates of what it would take to problem list, medication lists, allergies), upon on these two areas and believe they are advance interoperability. We have request’’ the most important to emphasize for this 12 For eligible hospitals the full proposed added a column in Table 2A to illustrate meaningful use Stage 1 objective is ‘‘Provide initial set of standards. We discuss the the standards that we believe should be patients with an electronic copy of their health adopted interoperability standards included in Certified EHR Technology information (including diagnostic test results, directly below and the adopted privacy to support meaningful use Stage 2. With problem list, medication lists, allergies, discharge and security standards in section summary, procedures), upon request’’ the exception of standards that are tied 13 For eligible professionals the full proposed III.C.2.c. to other HHS regulatory requirements, meaningful use Stage 1 objective is ‘‘Capability to With respect to interoperability this additional column represents our exchange key clinical information (for example standards we have, after considering the best estimate and does not in any way problem list, medication list, allergies, diagnostic recommendations of the HIT Standards imply the Secretary’s adoption of these test results) among providers of care and patient Committee, chosen to adopt alternative authorized entities electronically.’’ standards or limit the Secretary’s 14 For eligible hospitals the full proposed standards for certain purposes. Also, at discretion to adopt different standards meaningful use Stage 1 objective is ‘‘Capability to in the future. We look forward to exchange key clinical information (for example 15 Per section 3004(b)(1), we believe the standards receiving recommendations from the discharge summary, procedures, problem list, adopted address all applicable ‘‘areas required for medication list, allergies, diagnostic test results) consideration’’ under section 3002(b)(2)(B)—the HIT HIT Standards Committee to advance among providers of care and patient authorized Policy Committee required areas described above in interoperability in line with these entities electronically.’’ Section I of this interim final rule. estimates and welcome comments on

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the industry’s ability to implement these continuity of care document (CCD) that could meet the requisite technical candidate standards in time to support standard for the exchange of a patient goals was simply unavailable. Second, meaningful use Stage 2 (which is summary record and receives a patient to the extent that a potentially proposed to begin in 2013). summary record formatted in the equivalent voluntary consensus As an example of our future continuity of care record (CCR) standard was available, the standard expectations, currently adopted standard, their Certified EHR was too limiting and did not meet our certification criteria do not require the Technology must be capable of policy goals, including allowing for use of the vocabulary standard, interpreting the information within the greater innovation by the marketplace. RxNorm. However, RxNorm maintains CCR message and displaying it in We solicit comment on our approach links from the RxNorm concept unique human readable format. We do not and the availability of voluntary identifier (CUI) to the corresponding expressly state how this should be consensus standards that may be viable drug codes in other vocabularies. While accomplished or in what format human alternatives to any of the non-voluntary we have not adopted RxNorm as a readable information should be consensus standards we have adopted. standard in this initial set, we have displayed (e.g., information in a CCR a. Transport Standards adopted as a standard for medication message could be converted to a text file information the use of a vocabulary the or PDF). We only require that Certified With respect to transport standards, National Library of Medicine has EHR Technology must be capable of we have adopted Simple Object Access identified as an RxNorm drug data performing this function. We believe Protocol (SOAP) version 1.2 and source provider with a complete data set this requirement is critical and have Representational state transfer (REST) to integrated within RxNorm (additional included it to allow flexibility in the provide standard ways for systems to detail regarding this standard is marketplace during meaningful use interact with each other. SOAP and provided below). We believe this Stage 1 and to prevent good faith efforts REST are discussed in more detail standard will establish an important to exchange information from going to below. These standards are widely used bridge to full RxNorm adoption and will waste (i.e., information is exchanged, and implemented by the HIT industry help facilitate this transition over time. but is unreadable to both Certified EHR and were also recommended by the HIT We anticipate adopting certification Technology (machine readable) and Standards Committee. We understand criteria that requires Certified EHR humans). that the industry is already exploring Technology be capable of using the We discuss in more detail below the other standards beyond SOAP and RxNorm superset in its entirety to four categories identified above and the REST, and we look forward to receiving support meaningful use Stage 2 and standards adopted for each. At the end recommendations from the HIT look forward to HIT Standards of this section we provide in Table 2A Standards Committee in this regard to Committee recommendations in this the standards adopted for certain help enable innovation in the regard. exchange purposes to support marketplace rather than constrain it. As another example, we have adopted meaningful use Stage 1, as proposed in We recognize, out of the four a certification criterion that requires the Medicare and Medicaid EHR categories of standards identified above, Certified EHR Technology to be capable Incentive Programs proposed rule, as that the term ‘‘transport standard’’ may of receiving a message with Logical well as those candidate standards we be used by others to refer to what we Observation Identifiers Names and believe should be adopted and required have called a ‘‘content exchange Codes (LOINC®) codes from a in certification criteria to support standard.’’ In the interest of retaining the laboratory, retaining those LOINC® meaningful use Stage 2. categories recommended by the HIT codes, and using LOINC® codes to Finally, and consistent with the Standards Committee and to avoid populate a patient summary record. We National Technology Transfer and further confusion, we have chosen this do not require Certified EHR Advancement Act of 1995 (NTTAA) (15 categorization and believe the following Technology to be capable of mapping all U.S.C. 3701 et seq.) and OMB Circular distinction can be made to clarify the laboratory orders or tests to LOINC® A–119 16 (the circular), we have adopted meaning of the two terms in this interim codes. Rather, we require that Certified voluntary consensus standards final rule. Transport standards are not EHR Technology be capable of using wherever practical. We have noted with domain specific while content exchange LOINC® codes that are received and a superscript ‘‘+’’ (plus sign) those standards are. That is, SOAP and REST retained to populate a patient summary standards that are not voluntary can be used by other industries to record. Moreover, having LOINC® codes consensus standards. Both the NTTAA exchange information while the CCD, used internally for meaningful use Stage and the Circular require Federal for example, is specifically designed for 1 will prepare Certified EHR agencies to use technical standards that the exchange of health information. Technology for any future potential are developed or adopted by voluntary SOAP, originally defined as ‘‘Simple meaningful use Stage 2 requirements. consensus standards bodies, using such Object Access Protocol’’, is a protocol We believe the use of LOINC®, technical standards as a means to carry specification for exchanging structured Systematized Nomenclature of Medicine out policy objectives or activities. information in the implementation of Clinical Terms (SNOMED CT®), and Federal agencies, however, are not Web Services in computer networks. It other vocabulary standards will required to use such standards if doing relies on Extensible Markup Language accelerate the adoption and use of so would be ‘‘inconsistent with (XML) as its message format, and clinical decision support. Requiring applicable law or otherwise usually relies on other Application ® LOINC as a vocabulary standard that impractical.’’ In those instances in Layer protocols (most notably Remote Certified EHR Technology must have which we have not used voluntary Procedure Call (RPC) and HyperText the capability to support for meaningful consensus standards, we determined Transfer Protocol (HTTP)) for message use Stage 1 provides an incremental that to do so would be impractical for negotiation and transmission. SOAP can approach to achieving these future two principal reasons. First, in most form the foundation layer of a web goals. cases a voluntary consensus standard services protocol stack, providing a A final example would be, if an basic messaging framework upon which eligible professional uses Certified EHR 16 http://www.whitehouse.gov/omb/ web services can be built. The SOAP Technology that has implemented the circulars_a119. architecture consists of several layers of

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specifications for message format, future and potentially in time to support populate a patient summary record). message exchange patterns (MEP), meaningful use Stage 2. We welcome Apart from the standards specified underlying transport protocol bindings, public comments regarding these above, we do not specify the types of message processing models, and alternatives and specifically comments vocabularies or code sets that could protocol extensibility. SOAP was that can address the HIT industry’s potentially be used to populate the adopted because it is widely used and readiness to move to a single standard. remaining fields of a patient summary versatile enough to allow for the use of We also look forward to receiving record. As shown in Table 2A, we different transport protocols, is platform recommendations from the HIT anticipate adopting vocabulary independent, and is language Standards Committee in this regard. standards for many of the fields above independent. With respect to the vocabulary to support meaningful use Stage 2. For REST is a style of software standards for use within a patient example, we have not identified any architecture for distributed hypermedia summary record, and in support of code sets for medication allergies, but systems such as the Internet. Systems proposed meaningful Stage 1 objectives, we believe there is value to integrating which follow REST principles are often we expect the following fields to be both medication and non-medication referred to as ‘‘RESTful’’. An important populated: problem list; medication list; related allergies using a common concept in REST is the existence of Web medication allergy list; procedures; vital standard, and in providing ingredient- resources (sources of specific signs; units of measure; lab orders and based medication allergies. These information), each of which is results; and, where appropriate, requirements would be satisfied through referenced with a global identifier (e.g., discharge summary. At this time, the the use of the UNII standard (referenced a Uniform Resource Identifier or URI in Secretary has only adopted standards as a candidate Stage 2 standard in Table HTTP). In order to manipulate these related to the use of International 2A). We request public comment on the resources, ‘‘components’’ of the network Classification of Diseases, 9th Revision, standard we have adopted to populate (user agents and origin servers) Clinical Modifications (ICD–9–CM) or medication list information. SNOMED CT® to populate a problem communicate via a standardized ii. Drug Formulary Check interface (e.g., HTTP) and exchange list and ICD–9–CM or American ‘‘ ’’ Medical Association (AMA) Current For the purposes of performing a drug representations of these resources (the ® actual documents conveying the Procedural Terminology (CPT ) Fourth formulary check, Certified EHR information). A RESTful web service is Edition (CPT–4) to populate information Technology must be capable of using a simple web service implemented related to procedures. For medication NCPDP Formulary & Benefits Standard using HTTP and the principles of REST. lists, we have adopted a standard that 1.0 adopted by HHS (73 FR 18918) in requires the use of codes from a drug order to ensure in circumstances where b. Content Exchange and Vocabulary vocabulary the National Library of an eligible professional or eligible Standards Medicine has identified as an RxNorm hospital electronically prescribes a Part i. Patient Summary Record drug data source provider with a D drug for a Medicare Part D eligible complete data set integrated within individual, he/she can maintain With respect to meaningful use Stage RxNorm.17 For lab results, we have compliance with applicable law. We are 1, Certified EHR Technology will be adopted a standard that requires the use adopting this standard also to meet one required to be certified as being capable of LOINC® to populate information in a of the proposed meaningful use Stage 1 of (1) using the Health Level Seven patient summary record related to lab objectives, which seeks to have an (HL7) Clinical Document Architecture orders and results when LOINC® codes automated formulary check as a (CDA) Release 2 (R2) Level 2 CCD or have been received from a laboratory capability provided by Certified EHR ASTM CCR to electronically exchange a and are retained and subsequently Technology so that formulary and patient summary record; and 2) upon available to Certified EHR Technology. benefit information can be readily receipt of a patient summary record In instances where LOINC® codes have provided to advise an eligible formatted in an alternative standard, not been received from a laboratory, the professional or eligible hospital’s displaying it in human readable format. use of any local or proprietary code is decisions in prescribing drugs to a An HL7 CCD Level 2 allows the body of permitted (i.e., we do not require these patient. the CCD to be either structured XML local or proprietary codes to be iii. Electronic Prescribing text, or unstructured text, and provides converted to LOINC® codes in order to backward compatibility to CCD Level 1 For the purposes of electronic documents as well as a migration path 17 According to the most recent RxNorm Release prescribing, Certified EHR Technology to the more complex HL7 Version 3 Documentation File Full Release (11/2/09) must be capable of using NCPDP reference information model (RIM) published by the National Library of Medicine, the SCRIPT 8.1 or NCPDP SCRIPT 8.1 and based information found in CCD Level following RxNorm drug data source providers with 10.6. SCRIPT 8.1 is the current standard a complete data set integrated within RxNorm are 3. identified at the end of section 11.1 located at adopted by HHS for specified For the purposes of industry readiness http://www.nlm.nih.gov/research/umls/rxnorm/ transactions involving the and to further interoperability in a docs/2009/rxnorm_doco_full11022009.html GS— communication of a prescription or stepwise fashion, we have decided to 10/01/2009 (Gold Standard Alchemy); MDDB—10/ prescription-related information 07/2009 (Master Drug Data Base. Medi-Span, a adopt these two content exchange division of Wolters Kluwer Health); MMSL—10/01/ between prescribers and dispensers in standards as alternatives. We firmly 2009 (Multum MediSource Lexicon); MMX—09/28/ the Medicare Part D electronic believe one patient summary record 2009 (Micromedex DRUGDEX); MSH—08/17/2009 prescribing drug program. While it is standard should be adopted to support (Medical Subject Headings (MeSH)); MTHFDA—8/ not recognized as such at this time, we 28/2009 (FDA National Drug Code Directory); meaningful use Stage 2 and beyond. We MTHSPL—10/28/2009 (FDA Structured Product expect that SCRIPT 10.6 will be a believe that this is necessary to improve Labels); NDDF—10/02/2009 (First DataBank NDDF permitted backwards compatible patient care and access to health Plus Source Vocabulary); SNOMED CT—07/31/ alternative by the start of meaningful information as well as interoperability 2009 (SNOMED Clinical Terms (drug information) use Stage 1. Moreover, if SCRIPT 10.6 is SNOMED International); VANDF—10/07/2009 in general. We expect the industry to (Veterans Health Administration National Drug permitted, prior to any modification of move toward a single standard for File). We note that FDA Unique Ingredient the provisions of this interim final rule patient summary records in the near Identifiers (UNII) are a component of RxNorm. in response to public comment, we

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would expect to change our requirement 2013, placing compliance within Interchange Technical Report Type 3— to simply permit either SCRIPT 8.1 or meaningful use Stage 2, the 5010 and Health Care Claim: Professional (837), SCRIPT 10.6. Again, with respect to a D.0 HIPAA transaction standards are (ASC X12N/005010X222); and vocabulary standard, we have adopted a required to be used in the second year Æ The ASC X12N 837—Health Care standard that requires the use of codes of meaningful use Stage 1. Claim: Institutional, Volumes 1 and 2, from a drug vocabulary currently Consequently, in order for eligible Version 4010, (004010X096) and integrated into the RxNorm (see detailed professionals and eligible hospitals that Addenda to Health Care Claim: description above). We believe that adopt Certified EHR Technology to Institutional, Volumes 1 and 2, Version adopting RxNorm in the future will lead remain in compliance with the law for 4010, (004010X096A1) as well as ASC to improved interoperability and look conducting certain administrative X12 Standards for Electronic Data forward to receiving recommendations transactions, Certified EHR Technology Interchange Technical Report Type 3— from the HIT Standards Committee in must be capable of using both versions Health Care Claim: Institutional (837), this regard. of applicable adopted HIPAA (ASC X12N/005010X223), and Type 1 transaction standards. Errata to Health Care Claim: iv. Administrative Transactions • For retail pharmacy drugs and Institutional (837) ASC X12 Standards For the purposes of conducting dental, professional, and institutional for Electronic Data Interchange certain administrative transactions, health care eligibility benefit inquiry Technical Report Type 3 (ASC X12N/ Certified EHR Technology must be and response transactions (as defined at 005010X223A1). capable of using applicable HIPAA 45 CFR 162.1201) Certified EHR must be • To perform eligibility inquiry and transaction standards and Medicare Part capable of using the following response transactions between D standards adopted by the Secretary. standards: dispensers and Part D sponsors for Part This includes at least the following Æ NCPDP Telecommunications D prescription drugs. Accredited Standards Committee (ASC) Standards Implementation Guide, Æ NCPDP Telecommunications X12N Subcommittee standards or Version 5, Release 1 (Version 5.1), and Standards Implementation Guide, NCPDP standards for the relevant Version D, Release 0 (Version D.0) Version, 5, Release 1 (Version 5.1), and covered transactions. Because the equivalent NCPDP Batch Standards equivalent NCPDP Batch Standards HIPAA transactions standards Batch Implementation Guide, Versions Batch Implementation Guide, Version regulations reference the transaction 1.1 and 1.2; and 1.1. standards together with the Æ ASC X12N 270/271—Health Care v. Quality Reporting ‘‘implementation guides,’’ which are Eligibility Benefit Inquiry and Response, comprised of implementation Version 4010 (004010X092) and For the purposes of electronically specifications, we have chosen to Addenda to Health Care Eligibility submitting calculated quality measures identify the adopted standards and Benefit Inquiry and Response required by CMS or by States, Certified implementation specifications (004010X092A1) as well as ASC X12 EHR Technology must be capable of associated with these HIPAA Standards for Electronic Data using the CMS PQRI 2008 Registry XML transaction standards together rather Interchange Technical Report Type 3, Specification. We recognize that CMS than separately in section III.C.3 below. Version 5010 (ASC X12N/005010X279). has discussed in the Medicare and In adopting these standards and the • For retail pharmacy drugs and Medicaid EHR Incentive Programs implementation specifications, we have dental, professional, and institutional proposed rule potential approaches to referenced the CFR locations where they health care claims or equivalent quality reporting requirements for future have been adopted for the relevant encounter information transaction (as years of meaningful use and we HIPAA transactions, and as a result the defined at 45 CFR 162.1101): anticipate adopting standards as certification criteria will track the Æ NCPDP Telecommunications necessary and in consultation with CMS adopted HIPAA transactions standards Standards Implementation Guide, to support future quality reporting requirements. Consequently, as the Version 5, Release 1 (Version 5.1), and requirements. We also understand that HIPAA transaction standards are Version D, Release 0 (Version D.0) for the purposes of electronically updated or modified, Complete EHRs or equivalent NCPDP Batch Standards submitting quality measures an EHR Modules will be certified Batch Implementation Guide, Versions upcoming standard for Complete EHRs consistently with the current HIPAA 1.1 and 1.2; and and EHR modules may be the HL7 transaction standards requirements. We Æ ASC X12N 837—Health Care Claim: Quality Reporting Document intend, to the extent possible, to assure Dental—Version 4010 (004010X097) Architecture (QRDA) Implementation that Certified EHR Technology will and Addenda to Health Care Claim: Guide based on HL7 CDA Release 2 and enable covered entities to conduct Dental, Version 4010 (004010X097A1) we request public comment on whether HIPAA covered transactions as as well as ASC X12 Standards for this standard is mature enough to be ‘‘standard transactions,’’ as that term is Electronic Data Interchange Technical used in Complete EHRs and EHR defined in 45 CFR 162.103. Report Type 3—Health Care Claim: Modules during meaningful use Stage 1. However, in pursuing this approach Dental (837), (ASC X12N/005010X224), we note that in accordance with 45 CFR and Type 1 Errata to Health Care Claim: vi. Submission of Lab Results to Public 162.1102 and 45 CFR 162.1202, the Dental (837) ASC X12 Standards for Health Agencies Secretary currently permits the use of Electronic Data Interchange Technical For the purposes of submitting lab two versions of ASC X12N and NCPDP Report Type 3, (ASC X12N/ results to public health agencies, standards (Versions 4010/4010A and 005010X224A1); and Certified EHR Technology must be 5010 and Versions 5.1 and D.0, Æ ASC X12N 837—Health Care capable of using HL7 2.5.1. With respect respectively) until December 31, 2011, Claims: Professional, Volumes 1 and 2, to vocabulary standards for the at which point only the most recently Version 4010 (004010X098) and submission of lab results to public adopted HIPAA transaction standards Addenda to Health Care Claims: health agencies, we have adopted the will be permitted (74 FR 3296). Unlike Professional, Volumes 1 and 2, Version same standard for populating lab results the effective date for ICD–10–CM and 4010, (004010x098A1), as well as ASC as we do for the patient summary record ICD–10–PCS which is set for October 1, X12 Standards for Electronic Data above. We believe that enabling the use

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of UCUM and SNOMED CT® for this submission of information to public adopted at this time’’ it means that a exchange in the future would lead to health agencies for surveillance and Complete EHR or EHR Module would improved interoperability. reporting purposes. not be required to be tested and certified as including a particular standard. As a vii. Submission to Public Health viii. Submission to Immunization result, any local or proprietary standard Agencies for Surveillance or Reporting Registries could be used as well as the standard(s) For the purposes of electronically For the purposes of electronically listed as candidate meaningful use Stage submitting information to public health submitting information to immunization 2 standards. Unless marked with the agencies for surveillance and reporting, registries Certified EHR Technology following superscripts, all of the Certified EHR Technology must be must be capable of using HL7 2.3.1 or adopted standards are from the ONC capable of using HL7 2.3.1 or HL7 2.5.1 HL7 2.5.1 as a content exchange process that took place prior to the as a content exchange standard. This standard and the CDC maintained HL7 enactment of the HITECH Act or are requirement is not meant to include standard code set CVX—Vaccines required by other HHS regulations. adverse event reporting. At this time, we 18 Administered as the vocabulary • A number sign ‘‘#’’ indicates that the have not adopted a specific vocabulary standard. HIT Standards Committee standard for submitting information to recommended this standard to the public health agencies for surveillance ix. Table 2A National Coordinator but it was not part and reporting, and believe that such Table 2A below displays the of the prior ONC process. standards will be determined in large applicable adopted standards for each • part by the applicable public health exchange purpose specified. We have An asterisk ‘‘*’’ indicates that the agency receiving such information. We used ‘‘Cx’’ and ‘‘V’’ as shorthand for standard was neither recommended by look forward to receiving ‘‘content exchange’’ and ‘‘vocabulary,’’ the HIT Standards Committee nor part recommendations from the HIT respectively, to identify which standard of the prior ONC process. Standards Committee regarding category applies to the exchange • A plus sign ‘‘+’’ as mentioned above additional standards that should be purpose. Where a cell in table 2A indicates a standard that is not a adopted to facilitate the electronic includes the reference ‘‘no standard voluntary consensus standard.

TABLE 2A—ADOPTED CONTENT EXCHANGE AND VOCABULARY STANDARDS

Adopted standard(s) to support mean- Candidate standard(s) to support Row No. Purpose Category ingful use stage 1 meaningful use stage 2

1 ...... Patient Summary Record ...... Cx ...... HL7 CDA R2 CCD Level 2 or ASTM Alternatives expected to be narrowed CCR. based on HIT Standards Committee recommendations. • Problem List ...... V ...... Applicable HIPAA code set required Applicable HIPAA code set required by law (i.e., ICD–9–CM); or by law (e.g., ICD–10–CM) or SNOMED CT®. SNOMED CT®. • Medication List...... V ...... Any code set by an RxNorm drug RxNorm. data source provider that is identi- fied by the United States National Library of Medicine as being a com- plete data set integrated within RxNorm∂. • Medication Allergy List ...... V ...... No standard adopted at this time ...... UNII. • Procedures ...... V ...... Applicable HIPAA code sets required Applicable HIPAA code sets required by law (i.e., ICD–9–CM or CPT–4®). by law (i.e., ICD–10–PCS or CPT– 4®). • Vital Signs ...... V ...... No standard adopted at this time ...... CDA template. • Units of Measure ...... V ...... No standard adopted at this time ...... UCUM. • Lab Orders and Results ...... V ...... LOINC® when LOINC® codes have LOINC®. been received from a laboratory. 2 ...... Drug Formulary Check ...... Cx ...... Applicable Part D standard required Applicable Part D standard required by law (i.e., NCPDP Formulary & by law. Benefits Standard 1.0). 3 ...... Electronic Prescribing ...... Cx ...... Applicable Part D standard required NCPDP SCRIPT 10.6. by law (e.g., NCPDP SCRIPT 8.1) or NCPDP SCRIPT 8.1 and NCPDP SCRIPT 10.6. V ...... Any code set by an RxNorm drug RxNorm. data source provider that is identi- fied by the United States National Library of Medicine as being a com- plete data set integrated within RxNorm∂. 4 ...... Administrative Transactions ...... Cx ...... Applicable HIPAA transaction stand- Applicable HIPAA transaction stand- ards required by law. ards required by law. 5 ...... Quality Reporting ...... Cx ...... CMS PQRI 2008 Registry XML Speci- Potentially newer version(s) or stand- fication #,∂. ards based on HIT Standards Com- mittee Input.

18 The CDC’s National Center of Immunization HL7 external code set CVX http://www.cdc.gov/ and Respiratory Diseases (NCIRD) maintains the vaccines/programs/iis/stds/cvx.htm.

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TABLE 2A—ADOPTED CONTENT EXCHANGE AND VOCABULARY STANDARDS—Continued

Adopted standard(s) to support mean- Candidate standard(s) to support Row No. Purpose Category ingful use stage 1 meaningful use stage 2

6 ...... Submission of Lab Results to Public Cx ...... HL7 2.5.1 ...... Potentially newer version(s) or stand- Health Agencies. ards based on HIT Standards Com- mittee Recommendations. V ...... LOINC® when LOINC® codes have LOINC®, UCUM, and SNOMED CT® been received from a laboratory. or Applicable Public Health Agency Requirements. 7 ...... Submission to Public Health Agencies Cx ...... HL7 2.3.1 or HL7 2.5.1 ...... Potentially newer version(s) or stand- for Surveillance or Reporting (ex- ards based on HIT Standards Com- cluding adverse event reporting). mittee Input. V ...... According to Applicable Public Health GIPSE or According to Applicable Agency Requirements. Public Health Agency Require- ments. 8 ...... Submission to Immunization Reg- Cx ...... HL7 2.3.1 or HL7 2.5.1 ...... Potentially newer version(s) or stand- istries. ards based on HIT Standards Com- mittee Recommendations. V ...... CVX*,∂ ...... CVX.

c. Privacy and Security Standards These standards and their purposes are electronic protected health information We believe it is necessary for Certified displayed in Table 2B. For other is a reasonable and appropriate EHR Technology to provide certain capabilities, we have not adopted safeguard in its environment. privacy and security capabilities. In that specific standards because such Consequently, a HIPAA covered entity regard, we have aligned adopted capabilities can be appropriately could be in compliance with the HIPAA certification criteria to applicable addressed through different approaches, Security Rule if it determines that HIPAA Security Rule requirements and and we did not want to preclude encryption is not reasonable and believe that in doing so, such innovation. For example, while we have appropriate in its environment and it capabilities may assist eligible adopted a certification criterion related documents its rationale and implements professionals and eligible hospitals to to access control, we have not adopted an equivalent alternative measure if improve their overall approach to a specific standard for access control reasonable and appropriate. We hope privacy and security. In addition, some because we believe that the industry that by requiring Certified EHR may find that the capabilities provided will continue to innovate at a rapid pace Technology to include this capability, by Certified EHR Technology may in this area and better methods to that the use of encryption will become facilitate and streamline compliance implement this capability will be more prevalent. Of the certification with Federal and state privacy and available faster than we would be able criteria and associated standards we security laws. We believe that the to adopt them via regulation. On the have adopted related to encryption, the HIPAA Security Rule serves as an other hand, we have adopted first is for encryption in general while appropriate starting point for certification criteria and standards for the second is specific to when electronic establishing the capabilities for Certified encryption because specific industry health information is exchanged. The EHR Technology. That being said, the best practices and requirements exist first certification criterion and standard HITECH Act directs the HIT Policy with respect to encryption and the will assure that Certified EHR Committee, the HIT Standards strength of encryption algorithms. HHS Technology is capable of using Committee, and ONC to look at previously articulated in guidance encryption according to user-defined capabilities beyond those explicitly entitled ‘‘Guidance Specifying the preferences. There are several industry specified in the HIPAA Security Rule. Technologies and Methodologies That best practices in this regard and we We intend to work with both of these Render Protected Health Information expect that with the availability of the Committees to explore these areas and Unusable, Unreadable, or capability to perform encryption, where possible to adopt new Indecipherable to Unauthorized eligible professionals and hospitals will certification criteria and standards in Individuals’’ (74 FR 42741) that follow suit and enhance how they the future to improve the capabilities encryption is an effective method to protect electronic health information. Certified EHR Technology can provide ‘‘render protected health information We anticipate that this capability could to protect health information. unusable, unreadable, or indecipherable be used by eligible professionals and The adopted certification criteria in to unauthorized individuals,’’ and one eligible hospitals to encrypt backup Table 1 assure that Certified EHR that can exempt a HIPAA covered entity hard drives or tapes, removable media, Technology is capable of supporting from having to report a breach. To or portable devices. Finally, we expect eligible professionals and eligible further support this determination, we other functions or services such as hospitals comply with HIPAA believe a logical and practical next step domain name service, directory access, requirements to protect electronic and one that will provide eligible and consistent time (e.g., for audit logs) health information residing within professionals and eligible hospitals with to support and further enable some of Certified EHR Technology and, where a capability they may not have had in the standards in Table 2B. However, due appropriate, when such information is the past is to require Certified EHR to the fact these functions or services exchanged. For certain capabilities, we Technology to be capable of encryption. may be part of an overall have adopted, after considering the It is important to note, under 45 CFR implementation of Certified EHR recommendations of the HIT Standards 164.312(a)(2)(iv) and (e)(2)(ii), a HIPAA Technology (e.g., operating system, Committee, specific standards to be covered entity must assess whether network time server) rather than a used in Certified EHR Technology. encryption as a method for safeguarding specific capability Certified EHR

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Technology should be tested and capabilities of Certified EHR Certified EHR Technology alone does certified as including, we chose not to Technology and does not change not equate to compliance with the adopt certification criteria or standards. existing HIPAA Privacy Rule or Security HIPAA Privacy or Security Rules. The We request public comment on whether Rule requirements, guarantee capabilities provided by Certified EHR the previously mentioned functions or compliance with those requirements, or Technology do not affect in any way the services or any other function or service absolve an eligible professional, eligible analysis a HIPAA covered entity is should be considered for adoption by hospital, or other health care provider responsible for performing specified at the Secretary as a necessary capability who adopts Certified EHR Technology 45 CFR 164.306(b) and (d). Unless there for Certified EHR Technology to from having to comply with any are specific meaningful use measures for include. applicable provision of the HIPAA privacy and security that require the use After considering the written and oral Privacy or Security Rules. While the of a particular capability, an eligible public comments provided to both the capabilities provided by Certified EHR HIT Policy and HIT Standards Technology may assist an eligible professional or eligible hospital may Committees, we would like to clarify the professional or eligible hospital in find that its security practices exceed applicability of the privacy and security improving their technical safeguards in these capabilities and nothing in this certification criteria and standards order to meet some or all of the HIPAA rule precludes the use or adopted in this interim final rule. This Security Rule’s requirements or implementation of more protective interim final rule strictly focuses on the influence their risk analysis, the use of privacy and security measures.

TABLE 2B—ADOPTED PRIVACY AND SECURITY STANDARDS

Row No. Purpose Adopted standard

1 ...... General Encryption and Decryption of A symmetric 128 bit fixed-block cipher algorithm capable of using a 128, 192, or 256 Electronic Health Information. bit encryption key must be used (e.g., FIPS 197 Advanced Encryption Standard, (AES), Nov 2001).∂ 2 ...... Encryption and Decryption of Electronic An encrypted and integrity protected link must be implemented (e.g., TLS, IPv6, IPv4 Health Information for Exchange. with IPsec).∂ 3 ...... Record Actions Related to Electronic The date, time, patient identification (name or number), and user identification (name Health Information (i.e., audit log). or number) must be recorded when electronic health information is created, modi- fied, deleted, or printed. An indication of which action(s) occurred must also be re- corded (e.g., modification).∂ 4 ...... Verification that Electronic Health Informa- A secure hashing algorithm must be used to verify that electronic health information tion has not been Altered in Transit. has not been altered in transit. The secure hash algorithm used must be SHA–1 or higher (e.g., Federal Information Processing Standards (FIPS) Publication (PUB) Secure Hash Standard (SHS) FIPS PUB 180–3).∂ 5 ...... Cross-Enterprise Authentication ...... Use of a cross-enterprise secure transaction that contains sufficient identity informa- tion such that the receiver can make access control decisions and produce detailed and accurate security audit trails (e.g., IHE Cross Enterprise User Assertion (XUA) with SAML identity assertions).∂ 6 ...... Record Treatment, Payment, and Health The date, time, patient identification (name or number), user identification (name or Care Operations Disclosures. number), and a description of the disclosure must be recorded.∂

3. Adopted Implementation NHIN, for example, have been purposes such as electronic prescribing Specifications constrained even further and resulted in and laboratory test results, already have Pursuant to section 3004 of the PHSA, a narrow and unique set of available some of the most mature the Secretary is required to adopt implementation specifications, designed implementation specifications. We will implementation specifications in for a specific architecture and well- consider adopting implementation addition to standards and certification defined exchange. Based on input from specifications, though, for any or all criteria. Implementation specifications, HIT Standards Committee, we adopted standards provided that there is which for HIPAA covered transaction understand that very few convincing evidence submitted in standards are found in implementation implementation specifications are public comment of the specifications’ guides, provide specific configuration widely used and most are immature or maturity and widespread usage. instructions and constraints for too architecturally specific for adoption We have adopted a certification implementing a particular standard or by large segments of the HIT industry criterion requiring that Certified EHR set of standards. Because some before meaningful use Stage 2. Technology be capable of using the standards can be implemented in Given the importance of standard, CMS PQRI 2008 Registry XML several different ways, these implementation specifications and the Specification, for quality reporting. We specifications are critical in some cases analyses and field testing necessary to have also adopted as the to make interoperability a reality— refine them, we do not believe, with the implementation specifications for this simply using a standard does not exception of the few mentioned below, standard, the Physician Quality necessarily guarantee interoperability. that there are mature implementation Reporting Initiative Measure Standards Development Organizations specifications ready to adopt to support Specifications Manual for Claims and (SDOs), HITSP, and others have meaningful use Stage 1. We seek public Registry. Additionally, as we noted developed implementation comment on whether there are in fact above we have adopted standards that specifications with varying degrees of implementation specifications that are require Certified EHR Technology to be specificity, which in turn have resulted industry-tested and would not present a capable of using applicable HIPAA in varying degrees of interoperability. In significant burden if they were adopted. transaction standards adopted by HHS some cases, the standards used in the We believe that certain exchange for eligibility for health plan

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transactions and for health care claims recipients of Federal financial assistance c. Certification Criterion and Standard or equivalent encounter information must take reasonable steps to ensure Regarding Accounting of Disclosures transactions. In so doing, the specific meaningful access to their programs, Section 3004(b)(1) of the PHSA HIPAA standards and ‘‘implementation services, and activities by eligible requires the Secretary to adopt a specifications’’ associated with these limited English proficient persons. standard and certification criterion in covered transactions have also been this interim final rule that are consistent b. Human Readable Format adopted. As a supporting with section 3002(b)(2)(B)(iv) implementation specification for the As acknowledged in prior sections of (pertaining to technologies that, as part eligibility for health plan transactions this interim final rule, the initial set of of a Qualified EHR, allow for an HIPAA transaction standard we have adopted standards, implementation accounting of disclosures made by a also adopted the requirements of Phase HIPAA covered entity for purposes of 1 of the Council for Affordable Quality specifications, and certification criteria are only the beginning of what we treatment, payment, and health care Healthcare (CAQH) Committee on operations). This requirement is parallel expect will be an incremental approach Operating Rules for Information to section 13405(c) of the HITECH Act, to enhance the interoperability, Exchange (CORE). We request public which requires the Secretary to modify comment on the HIT industry’s functionality, and utility of health (no later than 6 months after the date on experience using CAQH CORE Phase 1 information technology. We believe that which the Secretary adopts standards on with adopted HIPAA transactions in order to recognize the enormous accounting for disclosures) the HIPAA standards. potential of HIT, greater standardization Privacy Rule at 45 CFR 164.528 to now Finally, in preparing to adopt future in future years is necessary. In that require that HIPAA covered entities implementation specifications to regard, we recognize that more account for disclosures related to support meaningful use Stage 2, ONC advanced interoperability requires treatment, payment, and health care plans to work with the HIT industry and health information to be represented by operations made through an electronic solicit input from relevant Federal specific vocabularies and code sets that health record and to identify in the advisory committees to obtain further can be interpreted by EHR technology as regulations the information that shall be specificity in the area of implementation well as converted and presented in a collected about each of the disclosures. specifications. We also encourage SDOs readable format to the users of such In promulgating these regulations, the to make widely available technology. At the present time we Secretary is instructed to ‘‘only require implementation specifications that can recognize that implementing certain such information to be collected be tested and adopted by the Secretary vocabularies and code sets in EHR through an electronic health record in a in the future. technology is a difficult, technical manner that takes into account the 4. Additional Considerations, undertaking. For that reason, we have interests of the individuals in learning Clarifications, and Requests for Public not adopted specific vocabularies and the circumstances under which their Comments code sets for a number of the exchange protected health information is being disclosed and takes into account the a. Relationship to Other Federal Laws purposes identified above in Table 2A. We have, however, as a transitional administrative burden of accounting for ’’ Nothing required by this interim final step, adopted certification criteria that such disclosures. Unless modified by the Secretary, the effective date 19 for rule should be construed as affecting require Certified EHR Technology to be existing legal requirements under other HIPAA covered entities that have capable of presenting health information Federal laws. While the capabilities acquired an electronic health record received in human readable format. By provided by Certified EHR Technology after January 1, 2009, is January 1, 2011, human readable format, we mean a may assist in the compliance with or anytime after this date when they certain legal requirements, they do not format that enables a human to read and acquire an electronic health record. in any way remove or alter those easily comprehend the information We intend for our adoption of a basic requirements. For example, Certified presented to them regardless of the certification criterion and standard to EHR Technology may be able to assist method of presentation (e.g., computer account for disclosures (§ 170.302(v) health care providers required to screen, handheld device, electronic and § 170.210(e), respectively) to comply with the Confidentiality of document). This would likely require provide a technical foundation for the Alcohol and Drug Abuse Patient information in coded or machine information that the Secretary will Records Regulation, 42 CFR Part 2, but readable format to be converted to, for subsequently determine should be it may not provide, from a technical example, its narrative English language collected for treatment, payment and perspective, all of the capabilities description. In an effort to further the health care operations disclosures. We necessary to comply with these transition to, and prevalence of, more have adopted a basic certification regulations. As another example, in specific vocabularies and code sets, we criterion that requires the capability to providing patients with access to their are interested in public comment record disclosures (as defined by the online health information, it is regarding industry readiness if we were HIPAA Privacy Rule) made for important to note that the accessibility to adopt certification criteria requiring treatment, payment, and health care requirements of the Americans with the use of additional vocabularies and operations in accordance with the Disabilities Act of 1990 and Section 504 code sets in parallel with meaningful standard we have adopted. The standard of the Rehabilitation Act of 1973 still use Stage 2. Such certification criteria specified in Table 2B above stipulates a apply to entities covered by these could include not only that Certified functional requirement that a recorded disclosure for treatment, payment, or Federal civil rights laws. Additionally, EHR Technology be capable of health care operations must include: Title VI of the Civil Rights Act of 1964 presenting information in human and its implementing regulations readable format but also that it be protect persons from unlawful 19 See HITECH Act section 13405(c)(4), which capable of automatically incorporating discrimination on the basis of race, also provides that the effective date for HIPAA certain vocabulary or code sets (i.e., covered entities that are current users of EHRs (i.e., color and national origin. Under Title VI machine readable information). acquired EHRs as of January 1, 2009) January 1, and its implementing regulations, 2014, unless modified by the Secretary.

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The date, time, patient identification date for the revised accounting-for- requirements subject to review by the (name or number), user identification disclosure regulations to as late as 2013 OMB under the Paperwork Reduction (name or number), and a description of for HIPAA covered entities that acquire Act (PRA). The HITECH Act establishes the disclosure. We believe date, time, electronic health records after January 1, new information collection patient identification, and user 2009. The Secretary will address the requirements, but those information identification are all readily available compliance date for accounting for collection requirements are addressed data because it is the same information treatment, payment, and health care by other regulatory and programmatic required in the standard for an audit log. operations disclosures in a later activities (e.g., the Medicare and We have also included the requirement rulemaking. In the interim, we again Medicaid EHR Incentive Programs that a ‘‘description of the disclosure’’ note that the standards and certification Proposed Rule). must be recorded; however, we have not requirements adopted do not affect a The HITECH Act applies through required any additional specificity for HIPAA covered entity’s compliance Section 13111(b) to ‘‘federal information what should be included in the with the HIPAA Privacy or Security collection activities.’’ The HITECH Act ‘‘description,’’ because the Secretary has Rules. states that ‘‘with respect to a standard or not yet weighed the interests of As the use of Certified EHR implementation specification adopted individuals with the administrative Technology becomes more widespread under section 3004 of the Public Health burden associated with accounting for and technology advances, we believe Service Act, as added by section 13101, such disclosures to determine what the ability to account for disclosures the President shall take measures to information shall be collected. The will continue to evolve. Accordingly, ensure that Federal activities involving certification criterion and standard in this first certification criterion and the broad collection and submission of this interim final rule are limited to standard for accounting of disclosures is health information are consistent with disclosures for treatment, payment, and intended as an incremental step, which such standard or implementation health care operations, as those terms will be refined as the technology specification, respectively, within three are defined at 45 CFR 164.501. This develops and regulatory requirements years after the date of such adoption.’’ interim final rule does not address the are issued. We plan to work with the Standards adopted in this interim final capability of Certified EHR Technology HIT Policy Committee and HIT rule may affect how Federal agencies to account for other types of disclosures. Standards Committee to receive collect information in the future; We note that a HIPAA covered entity recommendations regarding the policies however, the potential implications of using Certified EHR Technology must that should be established to address this requirement will largely depend on continue to account for disclosures in these standards and certification criteria actions taken by the Executive Office of accordance with 45 CFR 164.528, which requirements and with the HHS Office the President, including how it may require the collection of additional for Civil Rights to appropriately interprets the terms ‘‘consistent,’’ information for disclosures that are not coordinate the adoption of policies for ‘‘broad,’’ and ‘‘health information.’’ We for treatment, payment, or health care the accounting of treatment, payment, welcome comments on the potential for operations. and health care operations disclosures standards and implementation We do not propose additional with the capabilities that Certified EHR specifications adopted in this regulation requirements at this time because we Technology must include in the future. to change the way information is believe that several significant technical d. Additional Requests for Public collected by Federal agencies. We will challenges will need to be addressed share such comments with the OMB. before it is possible to record additional Comment information about disclosures in an • We are interested in public V. Regulatory Impact Analysis efficient manner. For example, we are comments to inform future deliberations A. Introduction unaware of any particular technology on whether specific certification criteria solution that is capable of automatically could be adopted to further promote the We have examined the impacts of this recognizing the difference between a capabilities Certified EHR Technology rule as required by Executive Order ‘‘use’’ and a ‘‘disclosure,’’ as the HIPAA should provide with respect to meeting 12866 on Regulatory Planning and regulations define these terms. the accessibility needs of individuals Review (September 30, 1993, as further Additionally, we are concerned about with disabilities. amended), the Regulatory Flexibility the amount of electronic storage that • We are also interested in public Act (RFA) (5 U.S.C. 601 et seq.), section will be necessary to record three years comments to inform future deliberations 202 of the Unfunded Mandates Reform worth of information related to on whether specific certification criteria Act of 1995 (2 U.S.C. 1532) (UMRA), treatment, payment, and health care could be adopted to further promote the Executive Order 13132 on Federalism operations disclosures. We welcome capabilities Certified EHR Technology (August 4, 1999), and the Congressional public comment, particularly from the should provide with respect to the Review Act (5 U.S.C. 804(2)). HIT developer community, as to these prevention and detection of potential Executive Order 12866 directs concerns as well as about the technical fraud, waste, and abuse. agencies to assess all costs and benefits feasibility of recording other elements of • We are interested in public of available regulatory alternatives and, information about a disclosure. We are comment regarding the ‘‘candidate if regulation is necessary, to select specifically interested in comments as standards to support meaningful use regulatory approaches that maximize to the technical feasibility of recording Stage 2’’ listed in Table 2A. We are net benefits (including potential the purpose or reason for the disclosure, specifically interested in feedback economic, environmental, public health to whom the disclosure was made (i.e., regarding implementation feasibility, and safety effects, distributive impacts, recipient), and any other elements that maturity, and prevalence in the and equity). A regulatory impact may be beneficial for a patient to know industry. analysis (RIA) must be prepared for about with respect to their health major rules with economically information. IV. Collection of Information significant effects ($100 million or more It is important to note, as discussed Requirements in any one year). We have determined above, that the Secretary has the This interim final rule contains no that this interim final rule is not an discretion to modify the compliance new information collection economically significant rule because

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we estimate that the costs to prepare professional or eligible hospital needs to order to be certified. Due to the fact that Complete EHRs and EHR Modules to be meet in order to qualify for an incentive the Medicare and Medicaid EHR tested and certified will be less than payment under the Medicare and Incentive Programs require (among $100 million per year. Nevertheless, Medicaid EHR Incentive Programs. other things) that eligible professionals because of the public interest in this and eligible hospitals use Certified EHR C. Costs and Benefits interim final rule, we have prepared an Technology in order to receive incentive RIA that to the best of our ability Throughout the following analysis we payments, we anticipate that presents the costs and benefits of the invite comments on specific portions of commercial vendors and open source interim final rule. We request comments our analysis. The public, however, is developers of Complete EHRs and EHR on the economic analysis provided in invited to offer comments on any and all Modules will respond by preparing such this interim final rule with comment. elements of the analysis and the technology to meet the certification The RFA requires agencies to analyze assumption underlying the analysis. criteria adopted in this interim final options for regulatory relief of small 1. Costs rule. We expect this to occur because businesses if a rule has a significant commercial vendors and open source impact on a substantial number of small This interim final rule is one of three developers who do not prepare entities. For more information on Small coordinated rulemakings (the other two Complete EHRs or EHR Modules to be Business Administration’s (SBA’s) size being the Medicare and Medicaid EHR tested and certified risk losing market standards, see the SBA’s Web site.20 Incentive Programs proposed rule and share (i.e., eligible professionals and Although the RFA only requires an the HIT Certification Programs proposed eligible hospitals seeking to achieve initial regulatory flexibility analysis rule) undertaken to implement the goals meaningful use will not buy Complete (IRFA) when an agency issues a and objectives of the HITECH Act EHRs or EHR Modules that cannot proposed rule, HHS has a policy of related to the adoption and meaningful outright or when combined with other voluntarily conducting an IRFA for use of Certified EHR Technology. Each EHR Modules meet the definition of interim final regulations. We examine rule’s preamble contains a RIA section. Certified EHR Technology). It is the burden of the interim final While there is no bright line that divides important to note, however, as regulation in Section V.D below. the effects of this interim final rule and discussed in section 3001(c)(5)(A) of the Section 202 of the UMRA also the other two noted above, we believe PHSA, that Congress intended for the requires that agencies assess anticipated that each analysis properly focuses on act of preparing for and subsequently costs and benefits before issuing any the direct effects of the provisions it seeking the certification of a Complete rule whose mandates require spending creates. This interim final rule estimates EHR or EHR Module to be voluntary. in any one year of $100 million in 1995 the costs commercial vendors, open As we discuss above, our analysis dollars, updated annually for inflation. source developers, and relevant Federal only focuses on the direct effects of the In 2009, that threshold is approximately agencies 21 will incur to prepare provisions created by this interim final $133 million. This rule will not impose Complete EHRs and EHR Modules to be rule. As a result, we only include an unfunded mandate on States, tribal tested and certified to adopted estimates for the costs commercial government or the private sector of more standards, implementation vendors, open source developers, and than $133 million annually. specifications, and certification criteria. relevant Federal agencies may incur to Executive Order 13132 establishes The Medicare and Medicaid EHR prepare Complete EHRs or EHR certain requirements that an agency Incentive Programs proposed rule Modules to be tested and certified. We must meet when it promulgates a estimates the impacts related to the do not include in this analysis the costs proposed rule (and subsequent final actions taken by eligible professionals or to eligible professionals and eligible rule) that imposes substantial direct eligible hospitals to become meaningful hospitals that choose to: (1) Purchase costs of compliance on State and local users, including purchasing or self- new Certified EHR Technology, or (2) governments, preempts State law, or developing Complete EHRs or EHR self-develop or modify their current, otherwise has Federalism implications. Modules. The HIT Certification HIT to become meaningful users. These We do not believe that our interim final Programs proposed rule estimates the costs are addressed in the Medicare and rule imposes substantial direct testing and certification costs for Medicaid EHR Incentive Programs compliance costs on State and local Complete EHRs and EHR Modules. proposed rule because they are directly governments, preempts State law, or This interim final rule adopts related to the actions taken by eligible otherwise has Federalism implications. standards, implementation professionals or eligible hospitals to specifications, and certification criteria become meaningful users. Additionally, B. Why Is This Rule Needed? and consequently establishes the the cost for Complete EHRs and EHR Section 3004(b)(1) of the PHSA capabilities that Complete EHRs or EHR Modules to be tested and certified is requires the Secretary to adopt an initial Modules will need to demonstrate in addressed in the HIT Certification set of standards, implementation Programs proposed rule and not in this specifications, and certification criteria 21 All Indian Health Service (IHS) facilities and interim final rule. by December 31, 2009. Certification the vast majority of Tribally-operated facilities In conducting research to inform the funded by IHS utilize the Resource and Patient estimates we make below we found criteria and associated standards and Management System (RPMS), the IHS health implementation specifications will be information and EHR system that is centrally several websites that listed, in an used to test and certify Complete EHRs developed and distributed by the IHS Office of aggregate format, different types of and EHR Modules in order to make it Information Technology. It is our understanding Complete EHRs and EHR Modules that IHS provides information technology support designed for various types of health care possible for eligible professionals and to over 40 IHS and Tribal hospitals as well as health eligible hospitals to adopt and care providers at approximately 300 ambulatory providers as well as those that were implement Certified EHR Technology. facilities. The RPMS EHR is designed for both designed primarily for specialists. Based The use of Certified EHR Technology is inpatient and ambulatory implementations and it is on our research, we believe it is IHS’s goal to remain consistent with the reasonable to assume that a few one of the requirements an eligible certification criteria adopted by the Secretary. As a result, we expect IHS will the RPMS EHR for testing hundred unique Complete EHRs and 20 http://sba.gov/idc/groups/public/documents/ and certification to applicable adopted certification EHR Modules make up the available sba_homepage/serv_sstd_tablepdf.pdf. criteria. universe of HIT for health care

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providers, including eligible certified to its 2007 or 2008 inpatient certification to certain certification professionals and eligible hospitals. certification criteria.22 23 24 Of these 74 criteria. We also assumed that the This estimate includes within it and 17 previously CCHIT-certified-EHRs certification criteria adopted by the specialty and other niche HIT that are we expect that 90% will be prepared for Secretary range from relatively simple not the intended focus of this interim certification to the certification criteria capabilities (e.g., recording a patient’s final rule. While certain certification adopted by the Secretary. We do not smoking status) to more sophisticated criteria may be applicable to these other believe that it is realistic to assume that capabilities (e.g., clinical decision types of HIT, the Secretary has not 100% of previously CCHIT-certified- support). As a result, we have made a adopted a specific or complete set of EHRs will be prepared for certification general assumption that the costs to certification criteria for them at this for a number of reasons. These reasons prepare Complete EHRs and EHR time. Therefore, our estimates for the include: (1) A recognition that mergers Modules to be tested and certified will impacts of this interim final rule solely and acquisitions within the marketplace vary depending on a number of factors focus on what we believe will be the have reduced the number of previously including, but not limited to, whether likely amount of Complete EHRs and CCHIT-certified-EHRs; (2) that the the Complete EHR or EHR Module: (1) EHR Modules that are prepared to be subsequent resources needed to market tested and certified and how much that and promote Certified EHR Technology Already includes the capability; (2) preparation will cost. may not be available at the present time; includes some aspect of the capability We have analyzed previously and (3) that some previously CCHIT- which would need to be updated; (3) developed CCHIT ambulatory and certified-EHRs will be tested and does not currently include the inpatient certification criteria and certified as EHR Modules rather than capability at all. We believe it is believe that many, but not all, require Complete EHRs. Given these reasonable to estimate that it will cost the exact same capabilities required by assumptions we have estimated the somewhere between $10,000 and the respective certification criteria number of previously CCHIT-certified- $250,000 per certification criterion to adopted by the Secretary at 45 CFR EHRs that will be prepared to be tested prepare a Complete EHR or EHR Module 170.302, 45 CFR 170.304, and 45 CFR and certified will be 65 and 15, for testing and certification taking into 170.306. Generally speaking, we believe ambulatory and inpatient, respectively. account the factors identified directly this overlap includes most of the We also believe it is reasonable to above. We have used this per clinically oriented capabilities required assume that of these 65 and 15, some certification criteria range as the basis by the certification criteria adopted by will require more preparation than for our low and high cost range the Secretary. Accordingly, with respect others (i.e., we assume that some estimates and for the ease of our to this impact analysis, we believe that previously CCHIT-certified-EHRs calculations assume that the Secretary a significant number of previously include more capabilities than what has adopted approximately 40 CCHIT-certified-EHRs will only incur CCHIT tested and certified and may be certification criteria. moderate costs to prepare for able to more easily meet the certification certification. We assume, for the criteria adopted by the Secretary). Given For Table 3 we have made the purposes of creating reasonable this assumption we have created low following assumptions: (1) In general, estimates, that previously CCHIT- and high ranges for the cost to prepare previously CCHIT-certified-EHRs will certified-EHRs are similar to our previously CCHIT-certified ambulatory need additional preparation to be tested definition of a Complete EHR. As a and inpatient EHRs. and certified to 25% of the certification result, we have based our estimates in In creating our low and high ranges criteria adopted by the Secretary; (2) the Table 3 with the expectation that these for the tables below we assumed based average low and high per certification previously CCHIT-certified-EHRs will on our analysis of previously developed criterion cost for previously CCHIT- again be prepared for certification as and required CCHIT certification criteria certified ambulatory EHRs to be Complete EHRs. To add further that certain capabilities (e.g., the prepared to be tested and certified will specificity to our estimates, we capability to maintain a medication list) be $50,000 and $150,000, respectively; understand, according to CCHIT’s Web have been implemented and deployed and (3) the average low and high per site, there are 74 CCHIT-certified-EHRs in HIT to such a large degree that there certification criterion cost for previously that have been certified to its 2008 would be little or no modification CCHIT-certified inpatient EHRs to be ambulatory certification criteria and 17 required to prepare Complete EHRs or prepared to be tested and certified will CCHIT-certified-EHRs, that have been EHR Modules for testing and be $75,000 and $200,000, respectively.

TABLE 3—ESTIMATED ONE-TIME COSTS FOR PREVIOUSLY CCHIT-CERTIFIED-EHRS TO BE PREPARED TO BE TESTED AND CERTIFIED AS COMPLETE EHRS (3-YEAR PERIOD)—TOTALS ROUNDED

Number One time cost per EHR ($M) Total cost for all EHRs over 3-year period Type prepared for ($M) certification Low High Mid-point Low High Mid-point

2008 Ambulatory CCHIT-Certified- EHR ...... 65 $0.50 $1.5 $1 .0 $32.5 $97.5 $65 .0 2007/2008 Inpatient CCHIT-Cer- tified-EHR ...... 15 0.75 2.0 1.38 11 .25 30 .0 20 .63

22 Some are marked with a conditional conditionally certified pending advanced transactions.’’ We do not believe that these caveats certification either ‘‘Pre-Market: These are ePrescribing EHRs that are in the process of have any effect on our estimates. conditionally certified EHRs which are new verifying their ability to conduct medication 23 http://www.cchit.org/products/Ambulatory— products that are fully certified once their history, formulary and eligibility checking through when certification years 2006 and 2007 are operational use at a physician office site has been a national network for electronic-prescribing unchecked. verified.’’ or ‘‘eRx Conditional: These are 24 http://www.cchit.org/products/Inpatient.

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TABLE 3—ESTIMATED ONE-TIME COSTS FOR PREVIOUSLY CCHIT-CERTIFIED-EHRS TO BE PREPARED TO BE TESTED AND CERTIFIED AS COMPLETE EHRS (3-YEAR PERIOD)—TOTALS ROUNDED—Continued

Number One time cost per EHR ($M) Total cost for all EHRs over 3-year period Type prepared for ($M) certification Low High Mid-point Low High Mid-point

Total ...... 80 ...... 43.75 127 .50 85.63

The second type of cost we estimate market due to the market share 26 out-of-date CCHIT–Certified-EHRs and includes the costs that we expect for represented by the previously CCHIT- never previously CCHIT-certified-EHRs CCHIT-certified ambulatory EHRs certified-EHRs included in Table 3 and will need additional preparation to be certified prior to 2008 (‘‘out-of-date the upfront costs required to bring a tested and certified to 60% of the CCHIT–Certified-EHRs’’) and never Complete EHR to market. As a result, we certification criteria adopted by the previously CCHIT-certified-EHRs to be expect there to be 8 and 5 Complete Secretary; (2) the average low and high prepared to be tested and certified as EHRs (for use by eligible professionals per certification criterion cost for Complete EHRs rather than being and eligible hospitals, respectively) Complete EHRs for eligible prepared to be tested and certified as an prepared to be tested and certified to all professionals to be prepared to be tested 25 EHR Module. We assume the EHR of the applicable certification criteria and certified will be $50,000 and technology that falls into this category 27 adopted by the Secretary. $150,000, respectively; and (3) the may require more extensive changes Again, using our general assumptions average low and high per certification than previously CCHIT-certified-EHRs discussed above (40 certification criteria identified in Table 3. Again, we have and a low and high range of $10,000 to criterion cost for Complete EHRs for estimated low and high preparation cost $250,000 per certification criterion) we eligible hospitals to be prepared to be ranges. We assume that there will be have made the following assumptions in tested and certified will be $75,000 and very little growth in the Complete EHR our Table 4 calculations: (1) In general, $200,000, respectively.

TABLE 4—ESTIMATED ONE-TIME COSTS FOR NEVER CCHIT-CERTIFIED-EHRS AND OUT-OF-DATE CCHIT–CERTIFIED- EHRS TO BE PREPARED TO BE TESTED AND CERTIFIED AS COMPLETE EHRS (3-YEAR PERIOD)—TOTALS ROUNDED

Number One time cost per EHR ($M) Total cost for all EHRs over 3-year period Type prepared for ($M) certification Low High Mid-point Low High Mid-point

Complete EHRs for Eligible Profes- sionals ...... 8 $1.2 $3.6 $2.4 $9 .6 $28.8 $19 .2 Complete EHRs for Eligible Hospitals 5 1.8 4.8 3.3 9.0 24.0 16 .5

Total ...... 13 ...... 18.60 52 .80 35 .70

Finally, the third type of cost we of capabilities: Electronic prescribing; estimate that there will be estimate relates to the number of EHR administrative transactions; core approximately 50 EHR Modules Modules we expect to be prepared to be clinical capabilities; computerized (number of modules X types of tested and certified and the costs provider order entry; quality reporting; modules) prepared to be tested and associated with that preparation. As online patient portals; and interfacing certified. Again, we have provided low discussed above, we believe over time with a health information organization and high preparation cost estimates in that EHR Modules will play an to enable the electronic exchange of Table 5 below. We assume that some of increasingly important role in health information. EHR Modules prepared for certification Generally speaking, of the available improving the capabilities available to will be capable of meeting applicable eligible professionals and eligible universe of HIT developers we assume certification criteria with little hospitals. It is also our belief that EHR that a small percentage will prepare the modification while other EHR Modules Modules will lead to a more innovative previously mentioned types of EHR and competitive marketplace. We Modules for certification prior to the may not. Given the potential differences believe that during meaningful use beginning of meaningful use Stage 2 in preparation costs and combinations Stage 1, approximately seven types of (i.e., between 2010 and 2012). of certification criteria to create EHR EHR Modules will be practical given the Furthermore, we assume during Modules we believe it is reasonable to current state of the HIT marketplace. We meaningful use Stage 1 there will be on estimate a wide range for the costs to assume that EHR Modules will most average 7 EHR Modules prepared to be prepare these types of EHR modules for likely be prepared to be tested and tested and certified for each type of EHR testing and certification. certified to provide the following types Module described above. As a result we

25 CCHIT began testing and certifying inpatient 26 http://www.cchit.org/about—‘‘* * * EHR be preparing the RPMS EHR as a Complete EHR to EHRs in 2007 and we assume that all of those EHRs products certified by mid-2009, representing over meet the applicable certification criteria adopted by are included in Table 3 which is why they are not 75% of the marketplace.’’ the Secretary for both ambulatory and inpatient included in this discussion. 27 This estimate includes the fact that IHS’s RPMS settings. EHR was not included in Table 1 and that it will

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TABLE 5—ESTIMATED ONE-TIME COSTS TO PREPARE EHR MODULES FOR CERTIFICATION TO APPLICABLE ADOPTED CERTIFICATION CRITERIA (3-YEAR PERIOD)—TOTALS ROUNDED

One time cost per EHR module ($M) Total cost all EHR modules over 3-year Number period Type prepared Low High Mid-point Low High Mid-point

EHR Modules ...... 50 $0.1 $0.5 $0.3 $5.0 $25.0 $15.0

Total ...... 50 ...... 5.0 25.0 15.0

We invite comments on the number of modest. We welcome comments on our Programs. We assume this factor will commercial vendors and open source estimates above. motivate a greater ratio of commercial developers of Complete EHRs or EHR In total, if we were to distribute the vendors and open source developers of Modules that make up the marketplace costs to prepare Complete EHRs and Complete EHRs and EHR Modules to and the number of Complete or EHR EHR Modules between 2010 and 2012 prepare such technology for testing and Modules that will be prepared for evenly per year we believe they would certification in 2010 and 2011 rather testing and certification. Because many likely be in the range of $67.35 to $205.3 than 2012. We also assume that it will of the adopted standards and million or $22.45 to $68.43 million per generally take 6 to 18 months for implementation specifications are year with an annual cost mid-point of commercial vendors and open source already in widespread use and because approximately about $45.44 million. developers of Complete EHRs and EHR many of the adopted certification However, we do not believe that the Modules to prepare for testing and criteria require core capabilities that costs will be spread evenly over these certification. As a result, we believe as already exist in the marketplace today three years due to market pressures and represented in Table 6 that the costs we believe that the costs incurred as a the fact that higher upfront incentive attributable to this interim final rule result of voluntary actions by the private payments are available under the will be distributed as follows: 45% for sector to prepare for certification will be Medicare and Medicaid EHR Incentive 2010, 40% for 2011 and 15% for 2012.

TABLE 6—DISTRIBUTED TOTAL PREPARATION COSTS (3-YEAR PERIOD)—TOTALS ROUNDED

Total low cost Total high cost Total average Year Ratio estimate estimate cost estimate (percent) ($M) ($M) ($M)

2010 ...... 45 $30.31 $92.39 $61.35 2011 ...... 40 26.94 82.12 54.53 2012 ...... 15 10.10 30.80 20.45

3-Year Totals ...... 67.35 205.3 136.33

Note that these cost estimates do not errors and unnecessary tests. The issues a proposed rule, HHS has a include additional costs to prepare for standards adopted will aid in fostering policy of voluntarily conducting an testing and certification that will likely greater interoperability. We also believe initial regulatory flexibility analysis for be incurred when we adopt additional that this interim final rule will be a interim final regulations. standards, implementation catalyst for a more competitive and We are implementing this interim specifications, and certification criteria innovative marketplace. Finally, final rule as required by section to support meaningful use Stages 2 and adopted certification criteria can be 3004(b)(1) of the PHSA. The objective of 3. We will account for costs associated used by commercial vendors and open the interim final rule is for the Secretary with these additional standards, source developers of Complete EHRs to adopt an initial set of standards, implementation specifications, and and EHR Modules as technical implementation specifications, and certification criteria in future requirements to ensure that their HIT certification criteria for HIT. rulemaking. can be tested and certified and subsequently adopted and implemented While commercial vendors and open 2. Benefits as Certified EHR Technology by eligible source developers of Complete EHRs We believe that there will be several professionals and eligible hospitals to and EHR Modules represent a small benefits from this interim final rule. By help them qualify for incentive segment of the overall information adopting this initial set, the Secretary payments under Medicare and Medicaid technology industry, we believe that the will set in motion what we believe will EHR Incentive Programs. entities impacted by this interim final rule most likely fall under the North be an iterative process to further D. Regulatory Flexibility Act Analysis enhance the interoperability, American Industry Classification functionality, utility, and security of The RFA requires agencies to analyze System (NAICS) code 541511 ‘‘Custom health information technology and to options for regulatory relief of small Computer Programming Services’’ support its meaningful use. The businesses if a rule has a significant specified at 13 CFR 121.201 where the capabilities required by adopted impact on a substantial number of small SBA publishes ‘‘Small Business Size certification criteria will help arm entities. As noted above, although the Standards by NAICS Industry.’’ The size health care providers with tools to RFA only requires an initial regulatory standard associated with this NAICS improve patient care, reduce medical flexibility analysis when an agency code is set at $25 million in annual

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receipts 28 which ‘‘indicates the rule) that imposes substantial direct SUBCHAPTER D—HEALTH INFORMATION maximum allowed for a concern and its requirement costs on State and local TECHNOLOGY affiliates to be considered small governments, preempts State law, or PART 170—HEALTH INFORMATION entities.’’ otherwise has federalism implications. Based on our analysis, we believe that TECHNOLOGY STANDARDS, a handful of multinational corporations Nothing in this interim final rule IMPLEMENTATION SPECIFICATIONS, and many national or regional imposes substantial direct requirement AND CERTIFICATION CRITERIA AND businesses represent a significant costs on State and local governments, CERTIFICATION PROGRAMS FOR majority of the potential Complete EHR preempts State law or otherwise has HEALTH INFORMATION and EHR Module developers and that federalism implications. We are not TECHNOLOGY aware of any State laws or regulations many, if not all, exceed the specified Subpart A—General Provisions SBA size standard. We make this that are contradicted or impeded by any assumption based on our understanding of the standards, implementation Sec. specifications, or certification criteria 170.100 Statutory basis and purpose. of the upfront investments necessary to 170.101 Applicability. develop and market HIT in a that have been adopted. This interim 170.102 Definitions. competitive marketplace as well as the final rule with comment period affords upgrade and product modification costs all States an opportunity to identify any Subpart B—Standards and Implementation that these businesses incur to stay Specifications for Health Information problems that our standards, Technology competitive. However, we note, and implementation specifications, and request public comment on, the 170.200 Applicability. certification criteria would create, and 170.202 Transport standards for exchanging following constraint encountered during to propose constructive alternatives. We our analysis. With the exception of electronic health information. welcome comments from State and local 170.205 Content exchange and vocabulary aggregate business information available governments. standards for exchanging electronic through the U.S. Census Bureau and the health information. SBA related to NAICS code 541511, it F. Unfunded Mandates Reform Act of 170.210 Standards for health information appears that many commercial vendors 1995 technology to protect electronic health and open source developers of Complete information created, maintained, and EHRs and EHR Modules are privately Title II of the Unfunded Mandates exchanged. held or owned and do not regularly, if Reform Act of 1995 (Pub. L. 104–4) 170.299 Incorporation by reference. at all, make their specific annual requires cost-benefit and other analyses Subpart C—Certification Criteria for Health receipts publicly available. As a result, before any rulemaking if the rule Information Technology it is difficult at the present time to includes a ‘‘Federal mandate that may 170.300 Applicability. locate empirical data related to many of result in the expenditure by State, local, 170.302 General certification criteria for the commercial vendors and open and tribal governments, in the aggregate, Complete EHRs or EHR Modules. source developers of Complete EHRs or by the private sector, of $100,000,000 170.304 Specific certification criteria for and EHR Modules to correlate to the or more (adjusted annually for inflation) Complete EHRs or EHR Modules SBA size standard. We therefore request in any 1 year.’’ The current inflation- designed for an ambulatory setting. public comment on any additional adjusted statutory threshold is 170.306 Specific certification criteria for information regarding the business size Complete EHRs or EHR Modules approximately $130 million. The designed for an inpatient setting. of commercial vendors and open source Department has determined that this developers of Complete EHRs and EHR Authority: 42 U.S.C 300jj–14; 5 U.S.C. rule would not constitute a significant 552. Modules in the HIT marketplace to help rule under the Unfunded Mandates inform our analysis. Reform Act, because it would impose no Subpart A—General Provisions Given the discussion above, we mandates. estimate that this interim final rule will § 170.100 Statutory basis and purpose. have effects on commercial vendors and The Office of Management and Budget The provisions of this subchapter open source developers of Complete reviewed this interim final rule with implement section 3004 of the Public EHRs and EHR Modules, some of which comment period. Health Service Act. may be small entities. However, we do List of Subjects in 45 CFR Part 170 not believe that the interim final rule § 170.101 Applicability. will create a significant economic Computer technology, Electronic The standards, implementation impact on a substantial number of these health record, Electronic information specifications, and certification criteria entities, regardless of size. The Secretary system, Electronic transactions, Health, adopted in this part apply to Complete certifies that this interim final rule will Health care, Health information EHRs and EHR Modules and the testing not have a significant impact on a technology, Health insurance, Health and certification of such Complete EHRs substantial number of small entities. records, Hospitals, Incorporation by and EHR Modules. E. Executive Order 13132—Federalism reference, Laboratories, Medicaid, § 170.102 Definitions. Executive Order 13132 establishes Medicare, Privacy, Reporting and For the purposes of this part: certain requirements that an agency recordkeeping requirements, Public must meet when it promulgates a health, Security. Certification criteria means criteria: (1) To establish that health proposed rule (and subsequent final ■ For the reasons set forth in the information technology meets preamble, the Department amends 45 28 applicable standards and The SBA references that annual receipts means CFR subtitle A to add subchapter D as ‘‘total income’’ (or in the case of a sole implementation specifications adopted proprietorship, ‘‘gross income’’) plus ‘‘cost of goods follows: by the Secretary; or sold’’ as these terms are defined and reported on Internal Revenue Service tax return forms. http:// (2) That are used to test and certify www.sba.gov/idc/groups/public/documents/ that health information technology sba_homepage/guide_to_size_standards.pdf. includes required capabilities.

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Certified EHR Technology means a electronically exchange health National Library of Medicine as being a Complete EHR or a combination of EHR information formatted in accordance complete data set integrated within Modules, each of which: with the standards adopted under RxNorm. (1) Meets the requirements included § 170.205. (B) [Reserved] in the definition of a Qualified EHR; and (a) Standard. The Organization for the (b) Drug formulary check. The (2) Has been tested and certified in Advancement of Structured Information Secretary adopts the following content accordance with the certification Standards (OASIS) Simple Object exchange standard for transmitting program established by the National Access Protocol (SOAP) Version 1.2 formulary and benefits information Coordinator as having met all applicable (incorporated by reference in § 170.299). between prescribers and Medicare Part certification criteria adopted by the (b) Alternative standard. A stateless, D sponsors. Secretary. client-server, cacheable (1) Standard. Drug formulary and Complete EHR means EHR technology communications protocol that adheres benefits information must be that has been developed to meet all to the principles of Representational transmitted in accordance with 42 CFR applicable certification criteria adopted State Transfer (REST) must be used. 423.160(b)(5). by the Secretary. (2) [ Reserved] Disclosure means the release, transfer, § 170.205 Content exchange and (c) Electronically transmitting vocabulary standards for exchanging prescription information. provision of access to, or divulging in electronic health information. any other manner of information outside (1) The Secretary adopts the following the entity holding the information. (a) Patient summary record. content exchange standard to provide (1) The Secretary adopts the following EHR Module means any service, for the transmission of a prescription or content exchange standards for the component, or combination thereof that prescription-related information. purposes of electronically exchanging a can meet the requirements of at least (i) Standard. An electronic patient summary record or to use in one certification criterion adopted by prescription for a Medicare Part D creating an electronic copy of a patient the Secretary. covered drug that is prescribed for a summary record: Implementation specification means Medicare Part D eligible individual (i) Standard. Health Level Seven specific requirements or instructions for must be transmitted in accordance with Clinical Document Architecture (CDA) implementing a standard. 42 CFR 423.160(b)(2)(ii), in all other Release 2, Level 2 Continuity of Care Qualified EHR means an electronic circumstances, if consistent with Document (CCD) (incorporated by record of health-related information on applicable state and other Federal law, reference in § 170.299). an individual that: electronic prescriptions may be (ii) Alternative standard. ASTM (1) Includes patient demographic and transmitted in accordance with 42 CFR E2369 Standard Specification for clinical health information, such as 423.160(b)(2)(ii) or using the NCPDP Continuity of Care Record and Adjunct medical history and problem lists; and SCRIPT Standard, Implementation to ASTM E2369 (incorporated by (2) Has the capacity: Guide, Version 10.6 (incorporated by reference in § 170.299). (i) To provide clinical decision reference in § 170.299). (2) The Secretary adopts the following support; (ii) [ Reserved] vocabulary standards for the purposes of (ii) To support physician order entry; (2) The Secretary adopts the following specifying the code set, terminology, or (iii) To capture and query information vocabulary standard for the purposes of nomenclature to use to represent health relevant to health care quality; and specifying the code set to use to information included in a patient (iv) To exchange electronic health represent health information included summary record: information with, and integrate such in electronic prescriptions. (i) Problem list. (i) Standard. Any code set by an information from other sources. (A) Standard. The code set specified RxNorm drug data source provider that Standard means a technical, for the conditions specified at 45 CFR is identified by the United States functional, or performance-based rule, 162.1002(a)(1). National Library of Medicine as being a condition, requirement, or specification (B) Alternative standard. International complete data set integrated within that stipulates instructions, fields, Health Terminology Standards RxNorm. codes, data, materials, characteristics, or Development Organization (IHTSDO) (ii) [ Reserved] actions. Systematized Nomenclature of Medicine (d) Electronically exchange ® Subpart B—Standards and Clinical Terms (SNOMED CT ) July administrative transactions. The Implementation Specifications for 2009 version (incorporated by reference Secretary adopts the following content Health Information Technology in § 170.299). exchange standards and associated (ii) Procedures. implementation specifications for the § 170.200 Applicability. (A) Standard. The code set specified following electronic transactions. The standards and implementation at 45 CFR 162.1002(a)(2). (1) Standard and implementation specifications adopted in this part apply (B) Alternative standard. The code set specifications. An eligibility for a health with respect to Complete EHRs and EHR specified at 45 CFR 162.1002(a)(5). plan transaction as defined at 45 CFR Modules. When a section of this part (iii) Laboratory orders and results. 162.1201 must be conducted in includes adoption of both a standard (A) Standard. Logical Observation accordance with: ® and at least one alternative standard, Identifiers Names and Codes (LOINC ) (i) 45 CFR 162.1202(b) or for the use of the specified standard or version 2.27, when such codes were period on and after January 1, 2012, in alternatives will be considered received within an electronic accordance with 45 CFR 162.1202(c); compliant. transaction from a laboratory and (incorporated by reference in § 170.299). (ii) The operating rules specified in § 170.202 Transport standards for (B) [Reserved] Phase 1 of the Council for Affordable exchanging electronic health information. (iv) Medication list. Quality Healthcare (CAQH) Committee The Secretary adopts the following (A) Standard. Any code set by an on Operating Rules for Information standards to define the common RxNorm drug data source provider that Exchange (CORE) (incorporated by transport methods that must be used to is identified by the United States reference in § 170.299).

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(2) Standard and implementation (ii) Alternative standard. HL7 2.5.1 in the Federal Register and the material specifications. Eligibility inquiry and (incorporated by reference in § 170.299). must be available to the public. All response transactions between (2) The Secretary adopts the following approved material is available for dispensers and Part D sponsors for Part vocabulary standard for electronic inspection at the National Archives and D prescription drugs must be conducted submissions to immunization registries. Records Administration (NARA). For in accordance with 42 CFR (i) Standard. HL7 Standard Code Set information on the availability of this 423.160(b)(3)(ii). CVX—Vaccines Administered, July 30, material at NARA, call 202–741–6030 or (3) Standard and implementation 2009 version (incorporated by reference go to http://www.archives.gov/ specifications. A health care claims or in § 170.299). federal_register/ equivalent encounter information (ii) [Reserved] code_of_federal_regulations/ transaction as defined at 45 CFR ibr_locations.html. Also, it is available 162.1101 must be conducted in § 170.210 Standards for health information for inspection at U.S. Department of technology to protect electronic health accordance with 45 CFR 162.1102(b) or information created, maintained, and Health and Human Services, Office of for the period on and after January 1, exchanged. the National Coordinator for Health 2012, in accordance with 45 CFR Information Technology, Hubert H. The Secretary adopts the following 162.1102(c). Humphrey Building, Suite 729D, 200 standards to protect electronic health (e) Electronically exchange quality Independence Ave, SW., Washington, information created, maintained, and reporting information. The Secretary DC 20201, call ahead to arrange for exchanged: adopts the following content exchange inspection at 202–690–7151, and is (a) Encryption and decryption of standard and implementation available from the sources listed below. electronic health information. specification for quality reporting. (b) Organization for the Advancement (1) General. A symmetric 128 bit (1) Standard. The CMS Physician of Structured Information Standards fixed-block cipher algorithm capable of Quality Reporting Initiative (PQRI) 2008 (OASIS), Post Office Box 455, Billerica, using a 128, 192, or 256 bit encryption Registry XML Specification MA 01821, http://www.oasis-open.org/ key must be used. (incorporated by reference in § 170.299). home/index.php, Telephone: 978–667– (2) Exchange. An encrypted and (2) Implementation specification. 5115. Physician Quality Reporting Initiative integrity protected link must be (1) Simple Object Access Protocol Measure Specifications Manual for implemented. (SOAP), Version 1.2 (Second Edition), Claims and Registry (incorporated by (b) Record actions related to parts 0–2, W3C Recommendation April reference in § 170.299). electronic health information. The date, 27, 2007 (SOAP version 1.2), IBR (f) Electronic submission of lab results time, patient identification, and user approved for § 170.202. to public health agencies. identification must be recorded when (i) SOAP version 1.2 PART 0: Primer; (1) The Secretary adopts the following electronic health information is created, (ii) SOAP version 1.2 PART 1: content exchange standard for the modified, deleted, or printed; and an Messaging Framework; and electronic submission of lab results to indication of which action(s) occurred (iii) SOAP version 1.2 PART 2: public health agencies. must also be recorded. Adjuncts. (i) Standard. HL7 2.5.1(incorporated (c) Verification that electronic health (2) [Reserved] by reference in § 170.299). information has not been altered in (c) Health Level Seven, 3300 (ii) [ Reserved] transit. Standard. A secure hashing Washtenaw Avenue, Suite 227, Ann (2) The Secretary adopts the following algorithm must be used to verify that Arbor, MI 48104; Telephone (734) 677– vocabulary standard for the purposes of electronic health information has not 7777 or http://www.hl7.org/. representing lab results in an electronic been altered in transit. The secure hash (1) Health Level Seven Standard submission to public health authorities. algorithm (SHA) used must be SHA–1 or Version 2.3.1 (HL7 2.3.1), An (i) Standard. Logical Observation higher. Application Protocol for Electronic Data Identifiers Names and Codes (LOINC®), (d) Cross-enterprise authentication. A Exchange in Healthcare Environments, version 2.27, when such codes were cross-enterprise secure transaction that April 14, 1999, IBR approved for received within an electronic contains sufficient identity information § 170.205. transaction from a laboratory such that the receiver can make access (2) Health Level Seven Messaging (incorporated by reference in § 170.299). control decisions and produce detailed Standard Version 2.5.1 (HL7 2.5.1), An (ii) [ Reserved] and accurate security audit trails must Application Protocol for Electronic Data (g) Electronic submission to public be used. Exchange in Healthcare Environments, health agencies for surveillance or (e) Record treatment, payment, and February 21, 2007, IBR approved for reporting. The Secretary adopts the health care operations disclosures. The § 170.205. following content exchange standards date, time, patient identification, user (3) Health Level Seven for electronic submission to public identification, and a description of the Implementation Guide: Clinical health agencies for surveillance or disclosure must be recorded for Document Architecture (CDA) Release reporting: disclosures for treatment, payment, and 2—Level 2 Continuity of Care Document (1) Standard. HL7 2.3.1 (incorporated health care operations, as these terms (CCD), April 01, 2007, IBR approved for by reference in § 170.299). are defined at 45 CFR 164.501. § 170.205. (2) Alternative standard. HL7 2.5.1 (d) ASTM International, 100 Barr (incorporated by reference in § 170.299). § 170.299 Incorporation by reference. Harbor Drive, PO Box C700, West (h) Electronic submission to (a) Certain material is incorporated by Conshohocken, PA, 19428–2959 USA; immunization registries. reference into this part with the Telephone (610) 832–9585 or http:// (1) The Secretary adopts the following approval of the Director of the Federal www.astm.org/. content exchange standards for Register under 5 U.S.C. 552(a) and 1 (1) ASTM E2369–05: Standard electronic submission to immunization CFR part 51. To enforce any edition Specification for Continuity of Care registries: other than that specified in this section, Record (CCR), year of adoption 2005, (i) Standard. HL7 2.3.1 (incorporated the Department of Health and Human ASTM approved July 17, 2006, IBR by reference in § 170.299). Services must publish notice of change approved for § 170.205.

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(2) ASTM E2369–05 (Adjunct to (2) 2009 Physician Quality Reporting active medication allergy list as well as E2369): Standard Specification Initiative Measure Specifications medication allergy history for Continuity of Care Record—Final Manual for Claims and Registry, Version longitudinal care. Version 1.0 (V1.0), November 7, 2005, 3.0, December 8, 2008 IBR approved for (e) Record and chart vital signs. IBR approved for § 170.205. § 170.205. (1) Vital signs. Enable a user to (e) National Council for Prescription electronically record, modify, and Drug Programs, Incorporated, 9240 E. Subpart C—Certification Criteria for retrieve a patient’s vital signs including, Raintree Drive, Scottsdale, AZ 85260– Health Information Technology at a minimum, the height, weight, blood pressure, temperature, and pulse. 7518; Telephone (480) 477–1000; and § 170.300 Applicability. Facsimile (480) 767–1042 or http:// (2) Calculate body mass index. www.ncpdp.org. The certification criteria adopted in Automatically calculate and display (1) SCRIPT Standard, Implementation this subpart apply to the testing and body mass index (BMI) based on a Guide, Version 10.6, October, 2008, certification of Complete EHRs and EHR patient’s height and weight. (Approval date for ANSI: November 12, Modules. (3) Plot and display growth charts. 2008), IBR approved for § 170.205. § 170.302 General certification criteria for Plot and electronically display, upon (2) [Reserved] Complete EHRs or EHR Modules. request, growth charts for patients 2–20 (f) Council for Affordable Quality years old. The Secretary adopts the following Healthcare (CAQH), 601 Pennsylvania (f) Smoking status. Enable a user to general certification criteria for Avenue, NW., South Building, Suite electronically record, modify, and Complete EHRs or EHR Modules. 500, Washington, DC 20004; Telephone retrieve the smoking status of a patient. Complete EHRs or EHR Modules must (202) 861–1492 or http://www.caqh.org/ Smoking status types must include: include the capability to perform the CORE_phase1.php. current smoker, former smoker, or never following functions electronically and (1) Committee on Operating Rules for smoked. in accordance with all applicable Information Exchange (CORE) Phase I (g) Incorporate laboratory test results. standards and implementation Eligibility and Benefits Operating Rules (1) Receive results. Electronically specifications adopted in this part: Manual, April, 2006, IBR approved for receive clinical laboratory test results in (a) Drug-drug, drug-allergy, drug- § 170.205. a structured format and display such (2) [Reserved] formulary checks. results in human readable format. (g) Regenstrief Institute, Inc., LOINC® (1) Alerts. Automatically and (2) Display codes in readable format. c/o Medical Informatics The Regenstrief electronically generate and indicate in Electronically display in human Institute, Inc 410 West 10th Street, Suite real-time, alerts at the point of care for readable format any clinical laboratory 2000 Indianapolis, IN 46202–3012; drug-drug and drug-allergy tests that have been received with Telephone (317) 423–5558 or http:// contraindications based on medication LOINC® codes. loinc.org/. list, medication allergy list, age, and (3) Display test report information. (1) Logical Observation Identifiers computerized provider order entry Electronically display all the Names and Codes (LOINC®) version (CPOE). information for a test report specified at 2.27, June 15, 2009, IBR approved for (2) Formulary checks. Enable a user to 42 CFR 493.1291(c)(1) through (7). § 170.205. electronically check if drugs are in a (4) Update. Enable a user to (2) [Reserved] formulary or preferred drug list in electronically update a patient’s record (h) U.S. National Library of Medicine, accordance with the standard specified based upon received laboratory test 8600 Rockville Pike, Bethesda, MD in § 170.205(b). results. 20894; Telephone (301) 594–5983 or (3) Customization. Provide certain (h) Generate patient lists. Enable a http://www.nlm.nih.gov/. users with administrator rights to user to electronically select, sort, (1) International Health Terminology deactivate, modify, and add rules for retrieve, and output a list of patients Standards Development Organization drug-drug and drug-allergy checking. and patients’ clinical information, based Systematized Nomenclature of Medicine (4) Alert statistics. Automatically and on user-defined demographic data, Clinical Terms (SNOMED CT®), electronically track, record, and medication list, and specific conditions. International Release, July 2009, IBR generate reports on the number of alerts (i) Report quality measures. approved for § 170.205. responded to by a user. (1) Display. Calculate and (2) [Reserved] (b) Maintain up-to-date problem list. electronically display quality measures (i) Centers for Disease Control and Enable a user to electronically record, as specified by CMS or states. Prevention, National Centers for modify, and retrieve a patient’s problem (2) Submission. Enable a user to Immunization and Respiratory Diseases list for longitudinal care in accordance electronically submit calculated quality Immunization Information System with: measures in accordance with the Support Branch—Informatics 1600 (1) The standard specified in standard and implementation Clifton Road Mailstop: E–62 Atlanta, GA § 170.205(a)(2)(i)(A); or specifications specified in § 170.205(e). 30333. (2) At a minimum, the version of the (j) Check insurance eligibility. Enable (1) HL7 Standard Code Set CVX— standard specified in a user to electronically record and Vaccines Administered, July 30, 2009, § 170.205(a)(2)(i)(B). display patients’ insurance eligibility, IBR approved for § 170.205. (c) Maintain active medication list. and submit insurance eligibility queries (2) [Reserved] Enable a user to electronically record, to public or private payers and receive (j) Centers for Medicare & Medicaid modify, and retrieve a patient’s active an eligibility response in accordance Services, Office of Clinical Standards medication list as well as medication with the applicable standards and and Quality, 7500 Security Boulevard, history for longitudinal care in implementation specifications specified Baltimore, Maryland 21244; Telephone accordance with the standard specified in § 170.205(d)(1) or (2). (410) 786–3000. in § 170.205(a)(2)(iv). (k) Submit claims. Enable a user to (1) CMS PQRI 2008 Registry XML (d) Maintain active medication allergy electronically submit claims to public or Specification, December 10, 2008 IBR list. Enable a user to electronically private payers in accordance with the approved for § 170.205. record, modify, and retrieve a patient’s standard and implementation

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specifications specified in health information across a network is conditions, diagnostic test results and/ § 170.205(d)(3). the one claimed and is authorized to or patient medication list. (l) Medication reconciliation. access such information in accordance (2) Alerts. Automatically and Electronically complete medication with the standard specified in electronically generate and indicate in reconciliation of two or more § 170.210(d). real-time, alerts and care suggestions medication lists by comparing and (u) Encryption. based upon clinical decision support merging into a single medication list (1) General. Encrypt and decrypt rules and evidence grade. that can be electronically displayed in electronic health information according (3) Alert statistics. Automatically and real-time. to user-defined preferences in electronically track, record, and (m) Submission to immunization accordance with the standard specified generate reports on the number of alerts registries. Electronically record, retrieve, in § 170.210(a)(1). responded to by a user. and transmit immunization information (2) Exchange. Encrypt and decrypt (f) Electronic copy of health to immunization registries in electronic health information when information. Enable a user to create an accordance with: exchanged in accordance with the electronic copy of a patient’s clinical (1) One of the standards specified in standard specified in § 170.210(a)(2). information, including, at a minimum, § 170.205(h)(1) and, at a minimum, the (v) Accounting of disclosures. Record diagnostic test results, problem list, version of the standard specified in disclosures made for treatment, medication list, medication allergy list, § 170.205(h)(2); or payment, and health care operations in immunizations, and procedures in: (2) The applicable state-designated accordance with the standard specified (1) Human readable format; and standard format. in § 170.210(e). (2) On electronic media or through (n) Public health surveillance. some other electronic means in Electronically record, retrieve, and § 170.304 Specific certification criteria for accordance with: transmit syndrome-based public health Complete EHRs or EHR Modules designed (i) One of the standards specified in for an ambulatory setting. surveillance information to public § 170.205(a)(1); health agencies in accordance with one The Secretary adopts the following (ii) The standard specified in of the standards specified in certification criteria for Complete EHRs § 170.205(a)(2)(i)(A), or, at a minimum, § 170.205(g). or EHR Modules designed to be used in the version of the standard specified in (o) Access control. Assign a unique an ambulatory setting. Complete EHRs § 170.205(a)(2)(i)(B); name and/or number for identifying and or EHR Modules must include the (iii) One of the standards specified in tracking user identity and establish capability to perform the following § 170.205(a)(2)(ii); controls that permit only authorized functions electronically and in (iv) At a minimum, the version of the users to access electronic health accordance with all applicable standard specified in § 170.205(a)(2)(iii); information. standards and implementation and (p) Emergency access. Permit specifications adopted in this part: (v) The standard specified in authorized users (who are authorized for (a) Computerized provider order § 170.205(a)(2)(iv). emergency situations) to access entry. Enable a user to electronically (g) Timely access. Enable a user to electronic health information during an record, store, retrieve, and manage, at a provide patients with online access to emergency. minimum, the following order types: their clinical information, including, at (q) Automatic log-off. Terminate an (1) Medications; a minimum, lab test results, problem electronic session after a predetermined (2) Laboratory; list, medication list, medication allergy time of inactivity. (3) Radiology/imaging; and list, immunizations, and procedures. (r) Audit log. (4) Provider referrals. (1) Record actions. Record actions (h) Clinical summaries. (b) Electronically exchange (1) Provision. Enable a user to provide related to electronic health information prescription information. Enable a user in accordance with the standard clinical summaries to patients for each to electronically transmit medication office visit that include, at a minimum, specified in § 170.210(b). orders (prescriptions) for patients in (2) Alerts. Provide alerts based on diagnostic test results, problem list, accordance with the standards specified user-defined events. medication list, medication allergy list, (3) Display and print. Electronically in § 170.205(c). immunizations and procedures. display and print all or a specified set (c) Record demographics. Enable a (2) Provided electronically. If the of recorded information upon request or user to electronically record, modify, clinical summary is provided at a set period of time. and retrieve patient demographic data electronically it must be: (s) Integrity. including preferred language, insurance (i) Provided in human readable (1) In transit. Verify that electronic type, gender, race, ethnicity, and date of format; and health information has not been altered birth. (ii) On electronic media or through in transit in accordance with the (d) Generate patient reminder list. some other electronic means in standard specified in § 170.210(c). Electronically generate, upon request, a accordance with: (2) Detection. Detect the alteration patient reminder list for preventive or (A) One of the standards specified in and deletion of electronic health follow-up care according to patient § 170.205(a)(1); information and audit logs, in preferences based on demographic data, (B) The standard specified in accordance with the standard specified specific conditions, and/or medication § 170.205(a)(2)(i)(A), or, at a minimum, in § 170.210(c). list. the version of the standard specified in (t) Authentication. (e) Clinical decision support. § 170.205(a)(2)(i)(B); (1) Local. Verify that a person or (1) Implement rules. Implement (C) One of the standards specified in entity seeking access to electronic automated, electronic clinical decision § 170.205(a)(2)(ii); health information is the one claimed support rules (in addition to drug-drug (D) At a minimum, the version of the and is authorized to access such and drug-allergy contraindication standard specified in § 170.205(a)(2)(iii); information. checking) according to specialty or and (2) Cross network. Verify that a person clinical priorities that use demographic (E) The standard specified in or entity seeking access to electronic data, specific patient diagnoses, § 170.205(a)(2)(iv).

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(i) Exchange clinical information and (6) Occupational therapy; electronic copy of the discharge patient summary record. (7) Respiratory therapy; instructions and procedures for a (1) Electronically receive and display. (8) Rehabilitation therapy; patient, in human readable format, at Electronically receive a patient’s (9) Dialysis; the time of discharge on electronic summary record, from other providers (10) Provider consults; and media or through some other electronic and organizations including, at a (11) Discharge and transfer. means. (b) Record demographics. Enable a minimum, diagnostic tests results, (f) Exchange clinical information and user to electronically record, modify, problem list, medication list, summary record. and retrieve patient demographic data medication allergy list, immunizations, (1) Electronically receive and display. and procedures in accordance with including preferred language, insurance type, gender, race, ethnicity, date of Electronically receive a patient’s § 170.205(a) and upon receipt of a summary record from other providers patient summary record formatted in an birth, and date and cause of death in the event of mortality. and organizations including, at a alternate standard specified in minimum, diagnostic test results, § 170.205(a)(1), display it in human (c) Clinical decision support. (1) Implement rules. Implement problem list, medication list, readable format. medication allergy list, immunizations, (2) Electronically transmit. Enable a automated, electronic clinical decision support rules (in addition to drug-drug procedures, and discharge summary in user to electronically transmit a patient accordance with § 170.205(a) and upon summary record to other providers and and drug-allergy contraindication checking) according to a high priority receipt of a patient summary record organizations including, at a minimum, formatted in an alternate standard diagnostic test results, problem list, hospital condition that use demographic data, specific patient diagnoses, specified in § 170.205(a)(1), display it in medication list, medication allergy list, human readable format. immunizations, and procedures in conditions, diagnostic test results and/ accordance with: or patient medication list. (2) Electronically transmit. Enable a (i) One of the standards specified in (2) Alerts. Automatically and user to electronically transmit a § 170.205(a)(1); electronically generate and indicate in patient’s summary record to other (ii) The standard specified in real-time, alerts and care suggestions providers and organizations including, § 170.205(a)(2)(i)(A), or, at a minimum, based upon clinical decision support at a minimum, diagnostic results, the version of the standard specified in rules and evidence grade. problem list, medication list, § 170.205(a)(2)(i)(B); (3) Alert statistics. Automatically and medication allergy list, immunizations, (iii) One of the standards specified in electronically track, record, and procedures, and discharge summary in § 170.205(a)(2)(ii); generate reports on the number of alerts accordance with: (iv) At a minimum, the version of the responded to by a user. (i) One of the standards specified in standard specified in § 170.205(a)(2)(iii); (d) Electronic copy of health § 170.205(a)(1); and information. Enable a user to create an (ii) The standard specified in (v) The standard specified in electronic copy of a patient’s clinical § 170.205(a)(2)(i)(A), or, at a minimum, § 170.205(a)(2)(iv). information, including, at a minimum, the version of the standard specified in diagnostic test results, problem list, § 170.205(a)(2)(i)(B); § 170.306 Specific certification criteria for medication list, medication allergy list, (iii) One of the standards specified in Complete EHRs or EHR Modules designed immunizations, procedures, and § 170.205(a)(2)(ii); for an inpatient setting. discharge summary in: The Secretary adopts the following (1) Human readable format; and (iv) At a minimum, the version of the certification criteria for Complete EHRs (2) On electronic media or through standard specified in § 170.205(a)(2)(iii); or EHR Modules designed to be used in some other electronic means in and an inpatient setting. Complete EHRs or accordance with: (v) The standard specified in EHR Modules must include the (i) One of the standards specified in § 170.205(a)(2)(iv). capability to perform the following § 170.205(a)(1); (g) Reportable lab results. functions electronically and in (ii) The standard specified in Electronically record, retrieve, and accordance with all applicable § 170.205(a)(2)(i)(A), or, at a minimum, transmit reportable clinical lab results to standards and implementation the version of the standard specified in public health agencies in accordance specifications adopted in this part: § 170.205(a)(2)(i)(B); with the standard specified in (a) Computerized provider order (iii) One of the standards specified in § 170.205(f)(1) and, at a minimum, the entry. Enable a user to electronically § 170.205(a)(2)(ii); version of the standard specified in record, store, retrieve, and manage, at a (iv) At a minimum, the version of the § 170.205(f)(2). minimum, the following order types: standard specified in § 170.205(a)(2)(iii); Dated: December 28, 2009. (1) Medications; and (2) Laboratory; (v) The standard specified in Kathleen Sebelius, (3) Radiology/imaging; § 170.205(a)(2)(iv). Secretary. (4) Blood bank; (e) Electronic copy of discharge [FR Doc. E9–31216 Filed 12–30–09; 4:15 pm] (5) Physical therapy; information. Enable a user to create an BILLING CODE 4150–45–P

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Part IV

The President Proclamation 8472—National Influenza Vaccination Week, 2010

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Federal Register Presidential Documents Vol. 75, No. 8

Wednesday, January 13, 2010

Title 3— Proclamation 8472 of January 8, 2010

The President National Influenza Vaccination Week, 2010

By the President of the United States of America

A Proclamation Since the first United States cases were identified in April of last year, our Nation has witnessed the worldwide spread of the H1N1 influenza virus. To date, tens of millions of Americans have contracted this virus. While the vast majority of those affected have recovered without incident, an unusually high proportion of children and younger adults have developed serious complications, resulting in hospitalization or even death. We know that influenza vaccination is the best way to protect ourselves against the flu, and my Administration moved swiftly to respond to this threat by assisting in the development of a vaccine, which is now widely available and has shown to be both safe and effective. Every American has a role to play in fighting the H1N1 flu. Expectant mothers, children, young adults, and all those under the age of 65 with chronic health conditions are at high risk for H1N1 flu-related complications and should get the vaccine as soon as possible. Those not at high risk can protect themselves and prevent the virus from spreading to more vulner- able members of their families and communities by getting vaccinated as well. This week presents a window of opportunity for us to prevent a possible third wave of H1N1 flu in the United States. I strongly encourage those who have not yet received the H1N1 flu vaccine to do so. Visit flu.gov to find vaccination sites in communities across our country and to stay informed. Together, we can all fight the H1N1 flu and help protect our families, friends, and neighbors. NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim the week of January 10–16, 2010, as National Influenza Vaccination Week. I encourage all Ameri- cans to observe this week by getting the H1N1 flu vaccine if they have not yet done so, and by asking their families, friends, and co-workers to do the same.

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IN WITNESS WHEREOF, I have hereunto set my hand this eighth day of January, in the year of our Lord two thousand ten, and of the Independence of the United States of America the two hundred and thirty-fourth.

[FR Doc. 2010–650 Filed 1–12–10; 11:15 am] Billing code 3195–W0–P

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Reader Aids Federal Register Vol. 75, No. 8 Wednesday, January 13, 2010

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING JANUARY

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20 CFR 100...... 748 41 CFR 49 CFR 416...... 1271 117 ...... 227, 1705, 1706 301–10...... 790 171...... 63 138...... 750 172...... 63 21 CFR 165 ...... 754, 1706, 1709 42 CFR 173...... 63 Proposed Rules: 522...... 1274 Proposed Rules: 175...... 63 529...... 1021 117...... 1738 178...... 63 147...... 803 412...... 1844 558...... 1275 413...... 1844 219...... 1547 39 CFR 422...... 1844 238...... 1180 23 CFR 544...... 1548 111...... 1540 495...... 1844 635...... 46 601...... 1541 830...... 922 24 CFR 3020...... 1280 44 CFR Proposed Rules: 172...... 1302 257...... 1686 Proposed Rules: 64...... 60 111...... 282 173...... 1302 175...... 1302 26 CFR 3050...... 1301 45 CFR 395...... 285 1...... 1704 40 CFR 170...... 2014 301...... 48 52 ...... 54, 56, 230, 232, 1284, 47 CFR 50 CFR Proposed Rules: 1543, 1712, 1715, 1716 1...... 1301 63...... 522 25...... 1285 17...... 235 31...... 1735 81...... 56, 1543 73...... 1546 21...... 927 301...... 94 180 ...... 760, 763, 767, 770 22...... 927 48 CFR 300...... 554 30 CFR 262...... 1236 263...... 1236 Proposed Rules: 635...... 250 250...... 1276 264...... 1236 225...... 832, 1567 648...... 1021 265...... 1236 660...... 932 31 CFR 252...... 832, 1567 266...... 1236 928...... 964 665...... 1023 1...... 743 271...... 918, 1236 931...... 964 679 ...... 554, 792, 1723 285...... 745 700...... 773 932...... 964 Proposed Rules: Proposed Rules: 721...... 773 933...... 964 17 ...... 1567, 1568, 1574, 1741, 240...... 95 723...... 773 935...... 964 1744 725...... 773 936...... 964 226...... 1582 32 CFR Proposed Rules: 937...... 964 300...... 1324 724...... 746 50...... 1566 941...... 964 17 ...... 286, 310, 606 Proposed Rules: 52 ...... 97, 283, 953, 958 942...... 964 223...... 316, 838 2004...... 1566 58...... 1566 949...... 964 224...... 316, 838 180...... 807 950...... 964 226...... 319 33 CFR 320...... 816 951...... 964 648...... 1024 27...... 1704 721...... 1180 952...... 964 660...... 1745

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pamphlet) form from the the Andean Trade Preference enacted public laws. To Superintendent of Documents, Act, and for other purposes. subscribe, go to http:// LIST OF PUBLIC LAWS U.S. Government Printing (Dec. 28, 2009; 123 Stat. listserv.gsa.gov/archives/ Office, Washington, DC 20402 3484) publaws-l.html This is a continuing list of (phone, 202–512–1808). The H.R. 3819/P.L. 111–125 public bills from the current text will also be made To extend the commercial session of Congress which available on the Internet from Note: This service is strictly space transportation liability have become Federal laws. It GPO Access at http:// for E-mail notification of new regime. (Dec. 28, 2009; 123 may be used in conjunction www.gpoaccess.gov/plaws/ laws. The text of laws is not Stat. 3486) with ‘‘P L U S’’ (Public Laws index.html. Some laws may available through this service. Update Service) on 202–741– not yet be available. Last List December 31, 2009 PENS cannot respond to 6043. This list is also H.R. 4314/P.L. 111–123 specific inquiries sent to this available online at http:// To permit continued financing address. www.archives.gov/federal- Public Laws Electronic of Government operations. register/laws.html. Notification Service (Dec. 28, 2009; 123 Stat. (PENS) The text of laws is not 3483) published in the Federal H.R. 4284/P.L. 111–124 Register but may be ordered To extend the Generalized PENS is a free electronic mail in ‘‘slip law’’ (individual System of Preferences and notification service of newly

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