Vol. 78 Wednesday, No. 152 August 7, 2013 Pages 48025–48282

Vol. 78 Wednesday, No. 152 August 7, 2013

Pages 48025–48282

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 78, No. 152

Wednesday, August 7, 2013

Agriculture Department Commerce Department See Commodity Credit Corporation See Economic Development Administration See Farm Service Agency See Industry and Security Bureau See Food and Nutrition Service See International Trade Administration See Forest Service See National Oceanic and Atmospheric Administration NOTICES Air Force Department Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 48137 Environmental Impact Statements; Availability, etc.: Proposed Relocation of 18th Aggressor Squadron to Joint Commodity Credit Corporation Base Elmendorf-Richardson, AK, 48151–48152 RULES Conservation Reserve Program, Re-Enrollment, 48035– Centers for Disease Control and Prevention 48037 NOTICES Meetings: Defense Department Board of Scientific Counselors, National Center for Health See Air Force Department Statistics, 48163–48164 See Navy Department PROPOSED RULES Centers for Medicare & Medicaid Services Federal Acquisition Regulations: RULES Contractor Comment Period, Past Performance Medicare Program: Evaluations, 48123–48125 Hospice Wage Index and Payment Rate; Update, 48234– NOTICES 48281 Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals, 48150–48151 Medicare Program: Meetings: Revised Process for Making National Coverage Defense Health Board, Federal Advisory Committee, Determinations, 48164–48169 48151 Privacy Act; Computer Matching Program, 48169–48171 Department of Transportation Children and Families Administration See Pipeline and Hazardous Materials Safety NOTICES Administration Agency Information Collection Activities; Proposals, Submissions, and Approvals: Drug Enforcement Administration Required Data Elements for Paternity Establishment NOTICES Affidavits, 48171–48172 Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances: Civil Rights Commission List I Chemicals Ephedrine, Pseudoephedrine, and NOTICES Phenylpropanolamine for 2013, 48193–48197 Meetings: South Dakota Advisory Committee, 48136 Economic Development Administration Meetings; Sunshine Act, 48136–48137 NOTICES Petitions by Firms for Determination of Eligibility to Apply Coast Guard for Trade Adjustment Assistance, 48137–48138 RULES Safety Zones: Education Department AVI Resort and Casino Labor Day Fireworks Display, RULES Colorado River, 48043–48044 Student Assistance General Provisions, 48048–48051 Kuoni Destination Management Fireworks; San Diego, NOTICES CA, 48046–48048 Applications: San Diego International Airport Terminal Two West Inviting Publishers to Submit Tests for Determination of Grand Opening Fireworks; San Diego, CA, 48044– Suitability for Use in the National Reporting System 48046 for Adult Education, 48152 PROPOSED RULES Meetings: Safety Zones: Advisory Committee on Student Financial Assistance, Chelsea River, Boston Inner Harbor, Boston, MA, 48085– 48152–48153 48087 NOTICES Employment and Training Administration Certificates of Alternative Compliance: NOTICES Uninspected Towing Vessel M/V IRON STAN, 48180 Agency Information Collection Activities; Proposals, Consolidation of Officer in Charge, Marine Inspection For Submissions, and Approvals: Outer Continental Shelf Activities: Employers Survey of the Short-Time Compensation Eighth Coast Guard District, 48180–48182 Program, 48199–48200

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Job Corps Placement and Assistance Record, 48197 Federal Highway Administration Workforce Information Grants to States, 48198–48199 NOTICES Buy America Policy, 48218 Energy Department Federal Maritime Commission See Federal Energy Regulatory Commission NOTICES Agreements Filed, 48163 Environmental Protection Agency RULES Federal Motor Carrier Safety Administration Pesticide Tolerances: PROPOSED RULES Topramezone, 48068–48075 Inspection, Repair, and Maintenance; Driver-Vehicle Significant New Use Rules on Certain Chemical Substances, Inspection Report, 48125–48133 48051–48068 PROPOSED RULES Federal Railroad Administration Air Quality State Implementation Plans; Approvals and NOTICES Promulgations: Emergency Orders: Illinois; Redesignation of the Chicago Area to Attainment Additional Requirements for Attendance and Securement of the 1997 Annual Fine Particulate Matter Standard, of Certain Freight Trains and Vehicles on Mainline 48103–48123 Track or Mainline Siding Outside of a Yard or Ohio; Redesignation of the Canton-Massillon Area to Terminal, 48218–48224 Attainment of the 1997 Annual and 2006 24-Hour Safety Advisories: Standards for Fine Particulate Matter, 48087–48103 Lac-Megantic Railroad Accident Discussion and DOT NOTICES Safety Recommendations, 48224–48229 Dioxin-Like Compounds in the United States: Update to An Inventory of Sources and Environmental Fish and Wildlife Service Releases for the Years 1987, 1995, and 2000, 48156– NOTICES 48158 Environmental Impact Statements and Assessments; Intents to Grant Exclusive Patent Licenses, 48158 Availability, etc.: Meetings: Rocky Mountain Arsenal National Wildlife Refuge, National Drinking Water Advisory Council, 48158–48159 Commerce City, CO; Two Ponds National Wildlife Preliminary 2012 Effluent Guidelines Program Plan and Refuge, Arvada, CO, 48183–48185 2011 Annual Effluent Guidelines Review Report, 48159–48161 Food and Drug Administration Proposed Consent Decrees under the Clean Air Act, 48161– NOTICES 48163 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 48172 Draft Guidance for Industry and Staff: Executive Office of the President Minimizing Risk for Children’s Toy Laser Products, See Presidential Documents 48172–48173 Guidance for Industry; Availability: Farm Service Agency Oversight of Clinical Investigations, A Risk-Based NOTICES Approach to Monitoring, 48173–48174 Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals: Anti-Infective Drugs Advisory Committee, 48174–48175 Guaranteed Farm Loan Program, 48135 Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances, 48175–48177 Federal Aviation Administration Withdrawal of Approval of a New Drug Application: PROPOSED RULES Purdue Pharma LP; OXYCONTIN, 48177 Class E Airspace: Danville, VA, 48079–48080 Food and Nutrition Service Magee, MS, 48080–48081 NOTICES Tazewell, TN, 48078–48079 Agency Information Collection Activities; Proposals, Proposed Establishment of Class E Airspace: Submissions, and Approvals: McConnellsburg, PA, 48081–48082 Enhancing Completion Rates for Supplemental Nutrition NOTICES Assistance Program Quality Control Reviews; Requests to Release Airport Property: Correction, 48135–48136 Ottumwa Regional Airport (OTM), Ottumwa, IA, 48217– Forest Service 48218 NOTICES New Recreation Fees, 48136 Federal Energy Regulatory Commission NOTICES General Services Administration Applications: PROPOSED RULES Tallgrass Interstate Gas Transmission, LLC, 48153–48154 Federal Acquisition Regulations: Transcontinental Gas Pipe Line Co., LLC, 48154–48155 Contractor Comment Period, Past Performance Hydroelectric Applications: Evaluations, 48123–48125 Rock River Beach, Inc.; Rock River Beach Hydroelectric Project, 48155–48156 Health and Human Services Department Staff Attendance, 48156 See Centers for Disease Control and Prevention

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See Centers for Medicare & Medicaid Services Countervailing Duty Administrative Reviews; Results, See Children and Families Administration Extensions, Amendments, etc.: See Food and Drug Administration Polyethylene Terephthalate Film, Sheet, and Strip from See National Institutes of Health India, 48147–48148 NOTICES Terminations of Suspended Investigations: Medicare Program: Lemon Juice from Mexico, 48148–48149 Revised Process for Making National Coverage Determinations, 48164–48169 International Trade Commission Meetings: NOTICES Protection of Human Subjects and Research Studying Complaints: Standard of Care Interventions, 48163 Certain Flash Memory Chips and Products Containing the Same, 48188–48189 Homeland Security Department Certain Point-to-Point Network Communication Devices See Coast Guard and Products Containing Same, 48189–48190 Determinations: Certain Audiovisual Components and Products Housing and Urban Development Department Containing the Same, 48190–48191 NOTICES Certain Linear Actuators, 48191–48192 Agency Information Collection Activities; Proposals, Meetings; Sunshine Act, 48192 Submissions, and Approvals: Promised Zones, 48182–48183 Justice Department See Drug Enforcement Administration Industry and Security Bureau NOTICES NOTICES Proposed Consent Decrees under CERCLA, 48192–48193 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Labor Department Report of Requests for Restrictive Trade Practice or See Employment and Training Administration Boycott, 48138 Land Management Bureau Denials of Export Privileges; Renewals: NOTICES Mahan Airways, Zarand Aviation, Gatewick LLC, et al., Meetings: 48138–48142 Steens Mountain Advisory Council, 48185 Interior Department National Aeronautics and Space Administration See Fish and Wildlife Service PROPOSED RULES See Land Management Bureau Federal Acquisition Regulations: See Reclamation Bureau Contractor Comment Period, Past Performance See Surface Mining Reclamation and Enforcement Office Evaluations, 48123–48125

Internal Revenue Service National Institutes of Health NOTICES NOTICES Agency Information Collection Activities; Proposals, Agency Information Collection Activities; Proposals, Submissions, and Approvals, 48229–48230 Submissions, and Approvals: Meetings: Autism Spectrum Disorder Research Portfolio Analysis, Taxpayer Advocacy Panel Joint Committee, 48231 48178–48179 Taxpayer Advocacy Panel Notices and Correspondence National Institute of Mental Health Data Access Request Project Committee, 48230 and Use Certification, 48177–48178 Taxpayer Advocacy Panel Tax Forms and Publications Meetings: Project Committee, 48231 Center for Scientific Review, 48179 Taxpayer Advocacy Panel Taxpayer Assistance Center Eunice Kennedy Shriver National Institute of Child Improvements Project Committee, 48232 Health and Human Development, 48179 Taxpayer Advocacy Panel Taxpayer Communications National Institute of Neurological Disorders and Stroke, Project Committee, 48230–48231 48179 Taxpayer Advocacy Panel Toll-Free Phone Line Project National Oceanic and Atmospheric Administration Committee, 48231 RULES Western Pacific Fisheries: International Trade Administration 2013 Annual Catch Limits and Accountability Measures; NOTICES Correcting Amendment, 48075 Agency Information Collection Activities; Proposals, PROPOSED RULES Submissions, and Approvals: Endangered and Threatened Wildlife and Plants: Textile Safeguard Provision of the United States-Peru 12-Month Finding and Proposed Endangered Listing of Free Trade, 48142–48143 Five Species of Sawfish under the Endangered Antidumping Duty Administrative Reviews; Results, Species Act, 48134 Extensions, Amendments, etc.: NOTICES Certain Pasta from Italy, 48146–48147 Agency Information Collection Activities; Proposals, Lemon Juice from Argentina, 48145 Submissions, and Approvals: Polyethylene Terephthalate Film, Sheet, and Strip from Statement of Financial Interests, Regional Fishery India, 48143–48145 Management Councils, 48149–48150

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National Science Foundation Securities and Exchange Commission NOTICES NOTICES Antarctic Conservation Act Permit Applications, 48200 Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals, 48204–48205 Advisory Committee for Environmental Research and Applications: Education, 48200–48201 Ranger Alternative Management, LP and Ranger Funds Permit Applications Received under the Antarctic Investment Trust, 48205–48211 Conservation Act, 48201 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 48212–48214 Navy Department Options Clearing Corp., 48214–48216 RULES International Regulations for Preventing Collisions at Sea; State Department Certifications and Exemptions, 48042–48043 NOTICES Culturally Significant Objects Imported for Exhibition Nuclear Regulatory Commission Determinations: RULES Heaven and Earth; Art of Byzantium from Greek Facility Security Clearance and Safeguarding of National Collections, 48216 Security Information and Restricted Data, 48037–48042 Culturally Significant Objects Imported for Exhibition: PROPOSED RULES Balthus: Cats and Girls—Paintings and Provocations, Facility Security Clearance and Safeguarding of National 48216 Security Information and Restricted Data, 48076–48078 Wols: Retrospective, 48216–48217 NOTICES Meetings: Draft Guidance for Industry and Staff: Shipping Coordinating Committee, 48217 Japan Lessons-Learned Project Directorate; Estimating Flooding Hazards Due to Dam Failure, 48201–48203 Surface Mining Reclamation and Enforcement Office Meetings: NOTICES Pacific Gas and Electric Co., Humboldt Bay Power Plant, Agency Information Collection Activities; Proposals, Unit 3; License Termination Plan, 48203 Submissions, and Approvals, 48188 Meetings; Sunshine Act, 48203–48204

Overseas Private Investment Corporation Transportation Department NOTICES See Federal Aviation Administration Meetings; Sunshine Act, 48204 See Federal Highway Administration See Federal Motor Carrier Safety Administration Peace Corps See Federal Railroad Administration PROPOSED RULES See Pipeline and Hazardous Materials Safety Freedom of Information Act Administration, 48083–48085 Administration

Pipeline and Hazardous Materials Safety Administration Treasury Department NOTICES See Internal Revenue Service Safety Advisories: Lac-Megantic Railroad Accident Discussion and DOT Safety Recommendations, 48224–48229 Separate Parts In This Issue

Presidential Documents Part II EXECUTIVE ORDERS Health and Human Services Department, Centers for Chemical Facility Safety and Security; Improvement (EO Medicare & Medicaid Services, 48234–48281 13650), 48029–48033 ADMINISTRATIVE ORDERS Palestinian Authority; Waiver of Restriction on Providing Funds (Presidential Determination) Reader Aids No. 2013–11 of July 26, 2013, 48025 Consult the Reader Aids section at the end of this page for Trafficking Victims Protection Act of 2000; Delegation of phone numbers, online resources, finding aids, reminders, Authority (Memorandum of July 29, 2013), 48027 and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents Reclamation Bureau LISTSERV electronic mailing list, go to http:// NOTICES listserv.access.gpo.gov and select Online mailing list Hydroelectric Power Development; Intent to Contract: archives, FEDREGTOC-L, Join or leave the list (or change San Juan-Chama Project, NM, 48185–48188 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 Executive Orders: 13650...... 48029 Administrative Orders: Memorandums: Memorandum of July 29, 2013 ...... 48027 Presidential Determinations: No. 2013–11 of July 26, 2013 ...... 48025 7 CFR 1410...... 48035 10 CFR 95...... 48037 Proposed Rules: 95...... 48076 14 CFR Proposed Rules: 71 (4 documents) ...... 48078, 48079, 48080, 48081 22 CFR Proposed Rules: 303...... 48083 32 CFR 706...... 48042 33 CFR 165 (3 documents) ...... 48043, 48044, 48046 Proposed Rules: 165...... 48085 34 CFR 668...... 48048 40 CFR 9...... 48051 180...... 48068 721...... 48051 Proposed Rules: 52 (2 documents) ...... 48087, 48103 81 (2 documents) ...... 48087, 48103 42 CFR 418...... 48234 48 CFR Proposed Rules: 42...... 48123 49 CFR Proposed Rules: 392...... 48125 396...... 48125 50 CFR 665...... 48075 Proposed Rules: 224...... 48134

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Federal Register Presidential Documents Vol. 78, No. 152

Wednesday, August 7, 2013

Title 3— Presidential Determination No. 2013–11 of July 26, 2013

The President Waiver of Restriction on Providing Funds to the Palestinian Authority

Memorandum for the Secretary of State

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 7040(b) of the Department of State, Foreign Operations, and Related Programs Appropria- tions Act, 2012 (Division I, Public Law 112–74) (the ‘‘Act’’) as carried forward by the Further Continuing Appropriations Act, 2013 (Division F, Public Law 113–6) (the ‘‘CR’’), I hereby certify that it is important to the national security interests of the United States to waive the provisions of section 7040(a) of the Act as carried forward by the CR, in order to provide funds appropriated to carry out chapter 4 of part II of the Foreign Assistance Act, as amended, to the Palestinian Authority. You are directed to transmit this determination to the Congress, with a report pursuant to section 7040(d) of the Act as carried forward by the CR, and to publish this determination in the Federal Register.

THE WHITE HOUSE, Washington, July 26, 2013

[FR Doc. 2013–19217 Filed 8–6–13; 8:45 am] Billing code 4710–10

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Memorandum of July 29, 2013

Delegation of Authority Pursuant to Sections 110(d)(4) and 110(f) of the Trafficking Victims Protection Act of 2000, as Amended

Memorandum for the Secretary of State

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby delegate to the Secretary of State the authority conferred upon the President by the Trafficking Victims Protection Act of 2000 (Division A of Public Law 106–386), as amended (the ‘‘Act’’), to determine, consistent with sections 110(d)(4) and 110(f) of the Act, with respect to Syria for Fiscal Year 2013, that assistance described in section 110(d)(1)(B) of the Act would promote the purposes of the Act or is otherwise in the national interest of the United States. You are authorized and directed to publish this memorandum in the Federal Register.

THE WHITE HOUSE, Washington, July 29, 2013

[FR Doc. 2013–19218 Filed 8–6–13; 8:45 am] Billing code 4710–10

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Executive Order 13650 of August 1, 2013 Improving Chemical Facility Safety and Security

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Purpose. Chemicals, and the facilities where they are manufactured, stored, distributed, and used, are essential to today’s economy. Past and recent tragedies have reminded us, however, that the handling and storage of chemicals are not without risk. The Federal Government has developed and implemented numerous programs aimed at reducing the safety risks and security risks associated with hazardous chemicals. However, additional measures can be taken by executive departments and agencies (agencies) with regulatory authority to further improve chemical facility safety and security in coordination with owners and operators. Sec. 2. Establishment of the Chemical Facility Safety and Security Working Group. (a) There is established a Chemical Facility Safety and Security Working Group (Working Group) co-chaired by the Secretary of Homeland Security, the Administrator of the Environmental Protection Agency (EPA), and the Secretary of Labor or their designated representatives at the Assistant Secretary level or higher. In addition, the Working Group shall consist of the head of each of the following agencies or their designated representatives at the Assistant Secretary level or higher: (i) the Department of Justice; (ii) the Department of Agriculture; and (iii) the Department of Transportation. (b) In carrying out its responsibilities under this order, the Working Group shall consult with representatives from: (i) the Council on Environmental Quality; (ii) the National Security Staff; (iii) the Domestic Policy Council; (iv) the Office of Science and Technology Policy; (v) the Office of Management and Budget (OMB); (vi) the White House Office of Cabinet Affairs; and (vii) such other agencies and offices as the President may designate. (c) The Working Group shall meet no less than quarterly to discuss the status of efforts to implement this order. The Working Group is encouraged to invite other affected agencies, such as the Nuclear Regulatory Commission, to attend these meetings as appropriate. Additionally, the Working Group shall provide, within 270 days of the date of this order, a status report to the President through the Chair of the Council on Environmental Quality and the Assistant to the President for Homeland Security and Counterter- rorism. Sec. 3. Improving Operational Coordination with State, Local, and Tribal Partners. (a) Within 135 days of the date of this order, the Working Group shall develop a plan to support and further enable efforts by State regulators, State, local, and tribal emergency responders, chemical facility owners and operators, and local and tribal communities to work together to improve chemical facility safety and security. In developing this plan, the Working Group shall:

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(i) identify ways to improve coordination among the Federal Government, first responders, and State, local, and tribal entities; (ii) take into account the capabilities, limitations, and needs of the first responder community; (iii) identify ways to ensure that State homeland security advisors, State Emergency Response Commissions (SERCs), Tribal Emergency Response Commissions (TERCs), Local Emergency Planning Committees (LEPCs), Tribal Emergency Planning Committees (TEPCs), State regulators, and first responders have ready access to key information in a useable format, including by thoroughly reviewing categories of chemicals for which information is provided to first responders and the manner in which it is made available, so as to prevent, prepare for, and respond to chemical incidents; (iv) identify areas, in collaboration with State, local, and tribal governments and private sector partners, where joint collaborative programs can be developed or enhanced, including by better integrating existing authorities, jurisdictional responsibilities, and regulatory programs in order to achieve a more comprehensive engagement on chemical risk management; (v) identify opportunities and mechanisms to improve response procedures and to enhance information sharing and collaborative planning between chemical facility owners and operators, TEPCs, LEPCs, and first responders; (vi) working with the National Response Team (NRT) and Regional Re- sponse Teams (RRTs), identify means for Federal technical assistance to support developing, implementing, exercising, and revising State, local, and tribal emergency contingency plans, including improved training; and (vii) examine opportunities to improve public access to information about chemical facility risks consistent with national security needs and appropriate protection of confidential business information. (b) Within 90 days of the date of this order, the Attorney General, through the head of the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), shall assess the feasibility of sharing data related to the storage of explosive materials with SERCs, TEPCs, and LEPCs. (c) Within 90 days of the date of this order, the Secretary of Homeland Security shall assess the feasibility of sharing Chemical Facility Anti-Ter- rorism Standards (CFATS) data with SERCs, TEPCs, and LEPCs on a categorical basis. Sec. 4. Enhanced Federal Coordination. In order to enhance Federal coordination regarding chemical facility safety and security: (a) Within 45 days of the date of this order, the Working Group shall deploy a pilot program, involving the EPA, Department of Labor, Department of Homeland Security, and any other appropriate agency, to validate best practices and to test innovative methods for Federal interagency collaboration regarding chemical facility safety and security. The pilot program shall operate in at least one region and shall integrate regional Federal, State, local, and tribal assets, where appropriate. The pilot program shall include innovative and effective methods of collecting, storing, and using facility information, stakeholder outreach, inspection planning, and, as appropriate, joint inspection efforts. The Working Group shall take into account the results of the pilot program in developing integrated standard operating procedures pursuant to subsection (b) of this section. (b) Within 270 days of the date of this order, the Working Group shall create comprehensive and integrated standard operating procedures for a unified Federal approach for identifying and responding to risks in chemical facilities (including during pre-inspection, inspection execution, post-inspection, and post-accident investigation activities), incident reporting and response procedures, enforcement, and collection, storage, and use of facility information. This effort shall reflect best practices and shall include agency-

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to-agency referrals and joint inspection procedures where possible and appropriate, as well as consultation with the Federal Emergency Management Agency on post-accident response activities. (c) Within 90 days of the date of this order, the Working Group shall consult with the Chemical Safety Board (CSB) and determine what, if any, changes are required to existing memorandums of understanding (MOUs) and processes between EPA and CSB, ATF and CSB, and the Occupational Safety and Health Administration and CSB for timely and full disclosure of information. To the extent appropriate, the Working Group may develop a single model MOU with CSB in lieu of existing agreements. Sec. 5. Enhanced Information Collection and Sharing. In order to enhance information collection by and sharing across agencies to support more informed decisionmaking, streamline reporting requirements, and reduce duplicative efforts: (a) Within 90 days of the date of this order, the Working Group shall develop an analysis, including recommendations, on the potential to improve information collection by and sharing between agencies to help identify chemical facilities which may not have provided all required information or may be non-compliant with Federal requirements to ensure chemical facility safety. This analysis should consider ongoing data-sharing efforts, other federally collected information, and chemical facility reporting among agencies (including information shared with State, local, and tribal governments). (b) Within 180 days of the date of this order, the Working Group shall produce a proposal for a coordinated, flexible data-sharing process which can be utilized to track data submitted to agencies for federally regulated chemical facilities, including locations, chemicals, regulated entities, previous infractions, and other relevant information. The proposal shall allow for the sharing of information with and by State, local, and tribal entities where possible, consistent with section 3 of this order, and shall address computer-based and non-computer-based means for improving the process in the short-term, if they exist. (c) Within 180 days of the date of this order, the Working Group shall identify and recommend possible changes to streamline and otherwise improve data collection to meet the needs of the public and Federal, State, local, and tribal agencies (including those charged with protecting workers and the public), consistent with the Paperwork Reduction Act and other relevant authorities, including opportunities to lessen the reporting burden on regulated industries. To the extent feasible, efforts shall minimize the duplicative collection of information while ensuring that pertinent information is shared with all key entities. Sec. 6. Policy, Regulation, and Standards Modernization. (a) In order to enhance safety and security in chemical facilities by modernizing key policies, regulations, and standards, the Working Group shall: (i) within 90 days of the date of this order, develop options for improved chemical facility safety and security that identifies improvements to existing risk management practices through agency programs, private sector initiatives, Government guidance, outreach, standards, and regulations; (ii) within 90 days of developing the options described in subsection (a)(i) of this section, engage key stakeholders to discuss the options and other means to improve chemical risk management that may be available; and (iii) within 90 days of completing the outreach and consultation effort described in subsection (a)(ii) of this section, develop a plan for implementing practical and effective improvements to chemical risk management identified pursuant to subsections (a)(i) and (ii) of this section. (b) Within 90 days of the date of this order, the Secretary of Homeland Security, the Secretary of Labor, and the Secretary of Agriculture shall develop a list of potential regulatory and legislative proposals to improve

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the safe and secure storage, handling, and sale of ammonium nitrate and identify ways in which ammonium nitrate safety and security can be enhanced under existing authorities. (c) Within 90 days of the date of this order, the Administrator of EPA and the Secretary of Labor shall review the chemical hazards covered by the Risk Management Program (RMP) and the Process Safety Management Standard (PSM) and determine if the RMP or PSM can and should be expanded to address additional regulated substances and types of hazards. In addition, the EPA and the Department of Labor shall develop a plan, including a timeline and resource requirements, to expand, implement, and enforce the RMP and PSM in a manner that addresses the additional regulated substances and types of hazards. (d) Within 90 days of the date of this order, the Secretary of Homeland Security shall identify a list of chemicals, including poisons and reactive substances, that should be considered for addition to the CFATS Chemicals of Interest list. (e) Within 90 days of the date of this order, the Secretary of Labor shall: (i) identify any changes that need to be made in the retail and commercial grade exemptions in the PSM Standard; and (ii) issue a Request for Information designed to identify issues related to modernization of the PSM Standard and related standards necessary to meet the goal of preventing major chemical accidents. Sec. 7. Identification of Best Practices. The Working Group shall convene stakeholders, including chemical producers, chemical storage companies, agricultural supply companies, State and local regulators, chemical critical infrastructure owners and operators, first responders, labor organizations representing affected workers, environmental and community groups, and consensus standards organizations, in order to identify and share successes to date and best practices to reduce safety risks and security risks in the production and storage of potentially harmful chemicals, including through the use of safer alternatives, adoption of best practices, and potential public- private partnerships. Sec. 8. General Provisions. (a) This order shall be implemented consistent with applicable law, including international trade obligations, and subject to the availability of appropriations. (b) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to a department, agency, or the head thereof; or (ii) the functions of the Director of OMB relating to budgetary, administrative, or legislative proposals.

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(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

THE WHITE HOUSE, August 1, 2013.

[FR Doc. 2013–19220 Filed 8–6–13; 8:45 am] Billing code 3295–F3

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Rules and Regulations Federal Register Vol. 78, No. 152

Wednesday, August 7, 2013

This section of the FEDERAL REGISTER DATES: Effective Date: August 7, 2013. easement restricts the production of contains regulatory documents having general FOR FURTHER INFORMATION CONTACT: agricultural commodities. applicability and legal effect, most of which It was never the intent or the policy are keyed to and codified in the Code of Beverly J. Preston; telephone 202–720– 9563. Persons with disabilities who of CCC to allow land with such crop use Federal Regulations, which is published under restrictions to be re-enrolled in CRP. 50 titles pursuant to 44 U.S.C. 1510. require alternative means for communications (Braille, large print, That provision was inadvertently added The Code of Federal Regulations is sold by audio tape, etc.) should contact the in the 2003 interim rule implementing the Superintendent of Documents. Prices of USDA Target Center at (202) 720–2600 2002 Farm Bill (the Farm Security and new books are listed in the first FEDERAL (voice and TDD). Rural Investment Act of 2002, Pub. L. REGISTER issue of each week. 107–171) changes to CRP, which was SUPPLEMENTARY INFORMATION: published in the Federal Register on Background May 8, 2003 (68 FR 24830–24845). The DEPARTMENT OF AGRICULTURE preamble to the 2003 interim rule, states CRP was first authorized in the Food specifically ‘‘ . . . any acreage currently Commodity Credit Corporation Security Act of 1985 (16 U.S.C. 3830– in the CRP will be basically eligible to 3835a, commonly known as the 1985 be offered for continued enrollment if 7 CFR Part 1410 Farm Bill). This rule amends the CRP the current contract is scheduled to RIN 0560–AH80 regulations in 7 CFR part 1410 to clarify expire the day before a new contract that land with use restrictions that would become effective. However, land Conservation Reserve Program, Re- prohibit the production of agricultural will be ineligible for enrollment if it is Enrollment commodities, typically through an subject to a CRP useful life easement easement or other deed restriction, is AGENCY: that extends beyond the current contract Commodity Credit Corporation, not eligible for re-enrollment in CRP. USDA. term. The interim rule provides that re- The purpose of CRP is to cost- ACTION: Final rule; Technical enrollment of currently enrolled acreage effectively assist producers in Amendment. will be based on the same criteria as for conserving and improving soil, water, enrolling new acreage.’’ SUMMARY: This rule makes a technical wildlife, and other natural resources by Nearly all FSA and CCC programs correction to the Commodity Credit converting environmentally-sensitive have specific prohibitions on duplicate Corporation (CCC) Conservation Reserve acreage generally devoted to the payments, meaning that beneficiaries Program (CRP) regulations to clarify that production of agricultural commodities may not receive payments from two land with use restrictions that prohibit to a long-term vegetative cover and to different programs for the same land, the production of agricultural address issues raised by State, regional, crop, or loss. Allowing for re-enrollment commodities, typically through an and national conservation initiatives. in CRP where the land is already under easement or other deed restrictions, is Participants enroll land in CRP an easement would be a type of not eligible for re-enrollment in CRP. contracts for 10 to 15 years in exchange duplicate payment, because landowners This is not a new policy and would not for annual rental payments and have already been compensated for the have affected any program financial assistance to install certain easement, usually by a State. CCC has determinations for recent CRP sign ups, conservation practices and to maintain not and should not pay participants had this change been specified in the approved vegetative, tree, or other annual CRP rental payments on land regulations at the time. This amendment appropriate covers. The purpose and where an easement already ensures that will improve the regulations by scope of CRP are not changing with this the conservation benefits established maintaining consistency with rule. under the original CRP contract will longstanding policy. This rule corrects a The regulations in 7 CFR 1410.6(c)(2) continue long term or even provision in the current regulations that specifies that land is ineligible for permanently. As noted in the preamble allows re-enrollment in CRP of land enrollment into CRP if the use of the to the final rule for CRP published in with easements or other deed land is restricted through deed or other the Federal Register on May 14, 2004 restrictions that restrict the production restrictions prior to enrollment in CRP (69 FR 26755–26763), no comments of agricultural commodities. A 2003 prohibiting the production of were received on the 2003 interim rule interim rule inadvertently added that agricultural commodities during any opposing the ineligibility provision for provision through an incorrect cross- part of the contract term. However, re-enrollment of land with easements, as reference, but clearly stated in the through an incorrect cross reference that specified in the preamble. CCC has not preamble that the intent was to exclude is being removed with this rule, this allowed such re-enrollment, as stated land with such easements or deed section also provides an exception to consistently in the handbooks for CRP. restrictions from re-enrollment. The the easement ineligibility if the land is However, the correction in this rule is purpose of CRP is to cost-effectively re-enrolled in the CRP during the final needed to make the regulations assist producers in conserving and year of an expiring CRP contract. As consistent with policy. improving soil, water, wildlife, and currently written, the regulation If re-enrollment of land with other natural resources by converting therefore allows for re-enrolling land restrictive easements were allowed, the environmentally-sensitive acreage from into CRP even if there is an easement in primary beneficiaries would be the production of agricultural place, or an easement has been filed that landowners whose land is enrolled at commodities to a long-term vegetative would begin as soon as the current CRP the State level in the Conservation cover. contract expires; even though such Reserve Enhancement Program (CREP).

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Many States require long term or even regulations, will improve the clarity of impede their full implementation. The permanent easements as a condition of the regulation and harmonize it with rule will not have retroactive effect. enrollment in CREP, and compensate longstanding USDA policy and existing Before any judicial action may be landowners for those easements. Since handbooks. brought regarding this rule, all such land already has easements, re- This technical amendment did not administrative remedies must be enrolling that land in CRP would force require Office of Management and exhausted. CCC to pay annual rental payments in Budget (OMB) designation of the level Executive Order 13132 exchange for no increase in of significance under Executive Order environmental benefits. If this 12866, ‘‘Regulatory Planning and This rule has been reviewed under correction is not made, and our existing Review,’’ and therefore OMB has not Executive Order 13132, ‘‘Federalism.’’ policy cannot be enforced, about 400– reviewed this rule. The policies contained in this rule 500 contracts could be re-enrolled for an would not have any substantial direct Regulatory Flexibility Act additional 10 to 15 years of rental effect on States, the relationship payments, at a potential cost to the The Regulatory Flexibility Act (5 between the Federal Government and government of $180–250 million total U.S.C. 601–612), as amended by the the States, or the distribution of power for no additional environmental Small Business Regulatory Enforcement and responsibilities among the various benefits. Since CRP has an enrollment Fairness Act of 1996 (SBREFA), levels of government. Nor would this cap, and CREP re-enrollments would be generally requires an agency to prepare rule impose substantial direct non-competitive, those 400–500 a regulatory flexibility analysis of any compliance costs on State and local contracts could potentially ‘‘crowd out’’ rule subject to the notice and comment governments. Therefore, consultation other applicants representing new, rulemaking requirements under the with the States is not required. additional actual environmental Administrative Procedure Act (5 U.S.C. Executive Order 13175 benefits. Therefore, this correction is 553) or any other statute, unless the needed to ensure that the limited CRP agency certifies that the rule will not This rule has been reviewed for funding goes to CRP contracts with have a significant economic impact on compliance with Executive Order specific environmental benefits. a substantial number of small entities. 13175, ‘‘Consultation and Coordination This rule is not subject to the Regulatory with Indian Tribal Governments.’’ Notice and Comment Flexibility Act because CCC is not Executive Order 13175 imposes This rule is technical in nature, not required to publish a notice of proposed requirements on the development of substantive, and a delay in rulemaking for this rule. regulatory policies that have tribal implementing this rule would be implications or preempt tribal laws. The contrary to the public interest. Environmental Review policies contained in this rule do not Therefore, this rule is effective on The environmental impacts of this preempt Tribal law. USDA continues to publication. Also, regulations for this rule have been considered in a manner consult with Tribal officials to have a program are exempt from the notice and consistent with the provisions of the meaningful consultation and comment requirements of the National Environmental Policy Act collaboration on the development and Administrative Procedure Act (5 U.S.C. (NEPA, 42 U.S.C. 4321–4347), the strengthening of USDA regulations. 553), as specified in section 2904 of the regulations of the Council on Unfunded Mandates 2008 Farm Bill (Pub. L. 110–246, the Environmental Quality (40 CFR parts Food, Conservation, and Energy Act of 1500–1508), and FSA regulations for Title II of the Unfunded Mandates 2008), which allows that the regulations compliance with NEPA (7 CFR part Reform Act of 1995 (UMRA, Pub. L. be promulgated and administered 799). The technical correction identified 104–4) requires Federal agencies to without regard to the notice and in this final rule does not change the assess the effects of their regulatory comment provisions of 5 U.S.C. 553 or structure or goals of the program and actions on State, local, and Tribal the Statement of Policy of the Secretary can be considered simply administrative governments or the private sector. of Agriculture effective July 24, 1971, in nature. Therefore, FSA has Agencies generally must prepare a (36 FR 13804) relating to notices of determined that NEPA does not apply to written statement, including a cost proposed rulemaking and public this final rule and no environmental benefit analysis, for proposed and final participation in rulemaking. assessment or environmental impact rules with Federal mandates that may result in expenditures of $100 million or Executive Order 12866 and 13563 statement will be prepared. more in any 1 year for State, local, or Executive Order 12866, ‘‘Regulatory Executive Order 12372 Tribal governments, in the aggregate, or Planning and Review,’’ and Executive This program is not subject to to the private sector. UMRA generally Order 13563, ‘‘Improving Regulation Executive Order 12372, requires agencies to consider and Regulatory Review,’’ direct agencies ‘‘Intergovernmental Review of Federal alternatives and adopt the more cost to assess all costs and benefits of Programs,’’ which requires consultation effective or least burdensome alternative available regulatory alternatives and, if with State and local officials. See the that achieves the objectives of the rule. regulation is necessary, to select notice related to 7 CFR part 3015, This rule contains no Federal mandates, regulatory approaches that maximize subpart V, published in the Federal as defined under title II of the UMRA, net benefits (including potential Register on June 24, 1983 (48 FR 29115). for State, local, and Tribal governments economic, environmental, public health or the private sector. Therefore, this rule Executive Order 12988 and safety effects, distributive impacts, is not subject to the requirements of and equity). Executive Order 13563 This rule has been reviewed under sections 202 and 205 of UMRA. emphasized the importance of Executive Order 12988, ‘‘Civil Justice quantifying both costs and benefits, of Reform.’’ The provisions of this rule Small Business Regulatory Enforcement reducing costs, of harmonizing rules, will not have preemptive effect with Fairness Act and of promoting flexibility. This respect to any State or local laws, This rule is not a major rule under the technical correction, which is the result regulations, or policies that conflict Small Business Regulatory Enforcement of a retrospective review of existing with such provision or which otherwise Fairness Act of 1996 (Pub. L. 104–121,

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SBREFA) and FSA is not required to NUCLEAR REGULATORY ADAMS accession number for each delay the effective date for 60 days from COMMISSION document referenced in this document the date of publication to allow for (if that document is available in Congressional review. Accordingly, this 10 CFR Part 95 ADAMS) is provided the first time that rule is effective on the date of a document is referenced. [NRC–2011–0268] • publication in the Federal Register. NRC’s PDR: You may examine and RIN 3150–AJ07 purchase copies of public documents at Federal Assistance Programs the NRC’s PDR, Room O1–F21, One Facility Security Clearance and White Flint North, 11555 Rockville The title and number of the Federal Safeguarding of National Security Pike, Rockville, Maryland 20852. Domestic Assistance Program in the Information and Restricted Data FOR FURTHER INFORMATION CONTACT: Catalog of Federal Domestic Assistance AGENCY: Nuclear Regulatory Daniel W. Lenehan, Office of the to which this rule applies is the Commission. General Counsel, U.S. Nuclear Conservation Reserve Program—10.069. ACTION: Direct final rule. Regulatory Commission, Washington, Paperwork Reduction Act DC 20555–0001; telephone: 301–415– SUMMARY: The U.S. Nuclear Regulatory 3501, email: [email protected]. The regulations in this rule are Commission (NRC) is updating its SUPPLEMENTARY INFORMATION: exempt from the requirements of the regulations to standardize the frequency of required security education training I. Background Paperwork Reduction Act (44 U.S.C. II. Discussion Chapter 35), as specified in section 2904 for employees of NRC licensees III. Section-by-Section Analysis of the 2008 Farm Bill, which provides possessing security clearances so that IV. Procedural Background that these regulations be promulgated such training will be conducted V. Compatibility of Agreement State and the programs in Title II of the 2008 annually consistent with the objectives Regulations Farm Bill be administered without of Executive Order 13526, Classified VI. Plain Writing regard to the Paperwork Reduction Act. National Security Information. The rule VII. Voluntary Consensus Standards allows licensees flexibility in VIII. Environmental Impact: Categorical E-Government Act Compliance determining the means and methods for Exclusion providing this training. This action IX. Paperwork Reduction Act Statement CCC is committed to complying with X. Regulatory Analysis establishes uniformity in the frequency XI. Regulatory Flexibility Act Certification the E-Government Act, to promote the of licensee security education and use of the Internet and other XII. Backfitting training programs and enhances the XIII. Congressional Review Act information technologies to provide protection of classified information. increased opportunities for citizen DATES: This rule is effective October 21, I. Background access to Government Information and 2013 unless significant adverse On December 29, 2009, the President services, and for other purposes. comments are received by September 6, signed Executive Order 13526, List of Subjects in 7 CFR Part 1410 2013. Classified National Security ADDRESSES: Please refer to Docket ID Information, which was published in Administrative practice and NRC–2011–0268 when contacting the the Federal Register on January 5, 2010 procedure, Agriculture, Environmental NRC about the availability of (75 FR 707). The Executive Order protection, Grant programs— information for this direct final rule. prescribes training requirements Agriculture, Natural resources, You may access information and applicable to the NRC for the proper Reporting and recordkeeping comment submittals related to this safeguarding of national security requirements, Soil conservation, direct final rule, which the NRC information and requires the NRC to Technical assistance, Water resources, possesses and is publicly available, by ensure that classified information Wildlife. any of the following methods: disseminated outside the executive • Federal Rulemaking Web site: Go to branch is protected ‘‘in a manner For the reasons explained above, CCC http://www.regulations.gov and search equivalent to that provided within the amends 7 CFR part 1410 as follows: for Docket ID NRC–2011–0268. Address executive branch.’’ The Information questions about NRC dockets to Carol Security Oversight Office (ISOO) within PART 1410—CONSERVATION Gallagher; telephone: 301–287–3422; the National Archives and Records RESERVE PROGRAM email: [email protected]. For Administration, which is responsible for technical questions, please contact the issuing guidance to Federal agencies on ■ 1. The authority citation for 7 CFR individual listed in the FOR FURTHER the implementation of the Executive part 1410 continues to read as follows: INFORMATION CONTACT section of this Order, issued a final rule (75 FR 37254; Authority: 15 U.S.C. 714b and 714c; 16 proposed rule. June 28, 2010) amending 32 CFR parts • U.S.C. 3801–3847. NRC’s Agencywide Documents 2001 and 2003 (ISOO Regulations). The Access and Management System final rule requires executive branch § 1410.6 [Amended] (ADAMS): You may access publicly agencies to conduct classified available documents online in the NRC information security refresher briefings ■ 2. Amend § 1410.6, paragraph (c)(2), Library at http://www.nrc.gov/reading- for all cleared employees at least by removing the words ‘‘and (3)’’. rm/adams.html. To begin the search, annually, and to provide derivative Signed on July 29, 2013. select ‘‘ADAMS Public Documents’’ and classification training for employees Juan M. Garcia, then select ‘‘Begin Web-based ADAMS authorized to apply derivative Executive Vice President, Commodity Credit Search.’’ For problems with ADAMS, classifications prior to exercising such Corporation. please contact the NRC’s Public authority and at least once every 2 years Document Room (PDR) reference staff at thereafter. This rulemaking will [FR Doc. 2013–19017 Filed 8–6–13; 8:45 am] 1–800–397–4209, 301–415–4737, or by establish standard training requirements BILLING CODE 3410–05–P email to [email protected]. The for NRC licensee security education and

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training programs in a manner authorized to apply derivative Commission pursuant to 32 CFR equivalent to that provided within the classifications prior to exercising such 2001.70(c). executive branch. authority and at least once every 2 years A new paragraph (e) has been added thereafter. This rulemaking will to specify that access by licensees’ II. Discussion standardize the frequency of required employees to classified information is The NRC is issuing this direct final security education training for NRC subject to a favorable eligibility rule to update part 95 of Title 10 of the licensee employees possessing security determination, signing an approved Code of Federal Regulations (10 CFR), clearances in a manner equivalent to non-disclosure agreement and the Facility Security Clearance and that provided within the executive employee’s need-to-know. This Safeguarding of National Security branch. requirement is equivalent to Information and Restricted Data, This direct final rule will establish requirements applicable to the § 95.33, Security Education. These standard training requirements for NRC Commission pursuant to Section 4.1(a) updates require NRC licensees (or their licensee security education and training of the Executive Order. designees) to conduct classified programs. Implementation of this rule Current paragraph (e) is redesignated information security refresher briefings will enhance the protection of classified as paragraph (f) and revised to specify for all cleared employees at least information, and ensure the protection that initial security training will be annually, and to provide derivative of classified information in a manner provided to every person who has met classification training for employees equivalent to that provided within the the criteria set forth in new paragraph authorized to apply derivative executive branch. Current NRC (e) before being granted access to classifications before exercising this regulations only require refresher classified information. This requirement authority and then at least once every 2 security education and training once is equivalent to requirements applicable years thereafter. This rule also gives every 3 years for all NRC licensee to the Commission pursuant to 32 CFR licensees flexibility in determining the personnel who handle or generate 2001.70(d)(1). means and methods for providing this classified information. Updating 10 CFR Current paragraph (f) is redesignated training. The NRC regulations at 10 CFR 95.33 to require annual training will as paragraph (g) and revised to specify 95.33 currently require NRC licensees, enhance the protection of classified that the requirement for conducting or their designees, to conduct classified information by ensuring that all NRC refresher briefings for all of a licensee’s information security refresher briefings licensee employees who create, process, cleared employees is changed from for all cleared employees every 3 years. or handle classified information have a every 3 years to at least annually. This These regulations do not mandate a satisfactory knowledge and requirement is equivalent to uniform training frequency for understanding of classification, requirements applicable to the derivative classifiers. safeguarding, and declassification Commission pursuant to 32 CFR The NRC has determined that policies and procedures. 2001.70(d)(4). requiring cleared licensee employees to Additionally, the current text of 10 Current paragraph (g) is redesignated undergo classified information security CFR 95.33 does not provide for as paragraph (i) and former paragraph refresher briefings at least annually and education and training of NRC licensee (h) is redesignated as paragraph (j). standardizing the derivative personnel authorized to apply New paragraph (h) specifies that classification training for licensee derivative classification markings. This derivative classifiers are to receive employees enhances the protection of rulemaking enhances the protection of training prior to derivatively classifying classified information by ensuring that classified information through uniform information and at least once every 2 cleared individuals are properly aware training requirements for derivative years. This requirement is equivalent to of their responsibilities to protect classifiers. The uniform standard will requirements applicable to the classified information and conform NRC have the beneficial effect of reducing Commission pursuant to 32 CFR regulations with executive branch instances of over-classification or 2001.70(d)(3). policies. improper classification, improper Minor editorial changes were also Section 4.1(e) of Executive Order safeguarding, and inappropriate or made to § 95.33. 13526, Classified National Security inadequate declassification practices. Information (75 FR 707; January 5, 2010) Finally, these updated requirements IV. Procedural Background (the Executive Order) requires the NRC are equivalent to requirements Because the NRC considers this action to ensure that classified information applicable to the Commission itself via to be non-controversial, the NRC is disseminated outside the executive the Executive Order and the ISOO using the direct final rule process for branch is protected ‘‘in a manner Regulations. The NRC has determined this rule. The amendments in this rule equivalent to that provided within the that the updated requirements in this will become effective on October 21, executive branch.’’ The Information final rule are consistent with the NRC 2013. However, if the NRC receives Security Oversight Office (ISOO) within obligation, stated in Section 4.1(e) of the significant adverse comments on this the National Archives and Records Executive Order, to ensure that the direct final rule by September 6, 2013, Administration is responsible for protection of classified information by then the NRC will publish a document issuing guidance to Federal agencies on NRC licensees is performed in a manner that withdraws this action and will the implementation of the Executive equivalent to that required within the subsequently address the comments Order. On June 28, 2010, ISOO issued executive branch. received in a final rule as a response to a final rule (75 FR 37254; June 28, 2010; the companion proposed rule published amending 32 CFR parts 2001 and 2003 III. Section-by-Section Analysis elsewhere in this issue of the Federal (ISOO Regulations)). The ISOO The initial paragraph of 10 CFR 95.33, Register. Absent significant Regulations require executive branch Security education, is amended to state modifications to the proposed revisions agencies to conduct classified that program officials are responsible for requiring republication, the NRC will information security refresher briefings determining the methods for providing not initiate a second comment period on for all cleared employees at least security education and training. This this action. annually, and to provide derivative requirement is equivalent to A significant adverse comment is a classification training for employees requirements applicable to the comment where the commenter

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explains why the rule would be Language in Government Writing,’’ security refresher training for all cleared inappropriate, including challenges to published June 10, 1998 (63 FR 31883). employees every 3 years. However, they the rule’s underlying premise or do not address initial or refresher VII. Voluntary Consensus Standards approach, or would be ineffective or training for persons who apply unacceptable without a change. A The National Technology Transfer derivative classification markings. comment is adverse and significant if: and Advancement Act of 1995, Public The NRC has determined that (1) The comment opposes the rule and Law 104–113, requires Federal agencies requiring cleared employees of NRC provides a reason sufficient to require a to use technical standards developed or licensees to undergo classified substantive response in a notice-and- adopted by voluntary consensus information security refresher briefings comment process. For example, a standards bodies unless the use of such at least annually and standardizing the substantive response is required when: a standard is inconsistent with derivative classification training for (A) The comment causes the NRC to applicable law or is otherwise cleared employees of NRC licensees will reevaluate (or reconsider) its position or impractical. This direct final rule enhance the protection of classified conduct additional analysis; amends the frequency of the training information. Annual classified (B) The comment raises an issue required for employees of NRC licensees information security refresher briefings serious enough to warrant a substantive handling classified information. This will help ensure that cleared employees response to clarify or complete the action is administrative in nature and of NRC licensees have adequate record; or does not involve the establishment or knowledge and understanding of proper classification policies and procedures (C) The comment raises a relevant application of a technical standard and thereby help reduce instances of issue that was not previously addressed containing generally applicable improper processing, handling, storage, or considered by the NRC. requirements. and declassification of classified (2) The comment proposes a change VIII. Environmental Impact: information. Standardized derivative or an addition to the rule and it is Categorical Exclusion classification training will help ensure apparent that the rule would be The NRC has determined that this that cleared employees of NRC licensees ineffective or unacceptable without direct final rule is the type of action will have a proper understanding of incorporation of the change or addition. described in categorical exclusions 10 derivative classification policies and (3) The comment causes the NRC to CFR 51.22(c)(1), (2), and (3)(iv). procedures and thereby help reduce make a change (other than editorial) to Therefore, neither an environmental instances of improper classification of the rule. impact statement nor an environmental derivative documents containing For detailed instruction on submitting assessment has been prepared for this classified information. a comment, please see the companion direct final rule. Furthermore, this rulemaking will proposed rule published elsewhere in bring the requirements for licensee this issue of the Federal Register. IX. Paperwork Reduction Act protection of classified information into Statement V. Compatibility of Agreement State alignment with two new requirements Regulations This direct final rule does not contain imposed on the Commission for the new or amended information collection protection of classified information by Under the ‘‘Policy Statement on requirements subject to the Paperwork Executive Order 13526 and the ISOO Adequacy and Compatibility of Reduction Act of 1995 (44 U.S.C. 3501 Regulations implementing the Agreement State Programs,’’ approved et seq.). Existing requirements were requirements of the Executive Order set by the Commission on June 30, 1997, approved by the Office of Management forth at 32 CFR part 2001. and published in the Federal Register and Budget (OMB), approval number The Executive Order and the ISOO on September 3, 1997 (62 FR 46517), 3150–0047. Regulations at 32 CFR 2001.70(d)(3) this rule is classified as Compatibility specify that Federal government Category ‘‘NRC.’’ Compatibility is not Public Protection Notification employees who ‘‘apply derivative required for Category ‘‘NRC’’ The NRC may neither conduct nor classification markings shall receive regulations. The NRC program elements sponsor, and a person is not required to training in the proper application of the in this category are those that relate respond to, an information collection derivative classification principles of directly to areas of regulation reserved request or requirement unless the the Executive Order prior to derivatively to the NRC by the Atomic Energy Act of requesting document displays a classifying information and at least once 1954, as amended, or the provisions of currently valid OMB control number. every 2 years.’’ Additionally, 32 CFR 10 CFR. Although an Agreement State 2001.70(d)(4) directs each U.S. may not adopt program elements X. Regulatory Analysis Government agency to ‘‘provide some reserved to the NRC, it may wish to The NRC has prepared a regulatory form of refresher security education and inform its licensees of certain analysis on this regulation. The analysis training at least annually for all its requirements via a mechanism that is examines the costs and benefits of the personnel who handle or generate consistent with the particular State’s alternatives considered by the NRC. classified information.’’ administrative procedure laws but does The purpose of this rulemaking is not confer regulatory authority on the Statement of the Problem and Reasons twofold. First, this rulemaking ensures State. for the Rulemaking that classified information possessed or The NRC regulations in 10 CFR part accessed by employees of NRC licensees VI. Plain Writing 95 establish procedures for safeguarding is effectively safeguarded. The NRC has The Plain Writing Act of 2010 (Pub. Secret and Confidential National determined that successful safeguarding L. 111–274) requires Federal agencies to Security Information and Restricted of classified information requires write documents in a clear, concise, and Data received or developed in effective security education and training well-organized manner. The NRC has conjunction with activities licensed, programs. The NRC has further written this document to be consistent certified, or regulated by the determined that updating its 10 CFR with the Plain Writing Act as well as the Commission. The requirements set forth part 95 security education and training Presidential Memorandum, ‘‘Plain in 10 CFR 95.33 currently require programs to achieve parity with the

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Executive Order and the ISOO Impacts on Licensees: Impacts upon cleared for storage will have to amend Regulations is necessary to ensure these licensees from this final rule will be their security plans to change the programs are effective. Second, this minimal. Only the three 10 CFR part 70 frequency of refresher training from 3 rulemaking ‘‘ensure[s] the protection of licensees and one Part 76 Certificate years to annually. These contractors are [classified] information in a manner holder, for which the NRC is the not required to have derivative equivalent to that provided within the Cognizant Security Agency (CSA), classifiers. executive branch,’’ as required by would be affected by the rule. A fourth Section 4.1(e) of the Executive Order by 10 CFR part 70 licensee will be affected XI. Regulatory Flexibility Act updating training requirements later this year when it becomes a Certification applicable to licensees to be equivalent possessor of classified matter. Of those Under the Regulatory Flexibility Act, to training requirements applicable to three, two already commit in their 5 U.S.C 605(b), the Commission certifies the Commission itself. internal procedures to annual security education briefings of all their that this direct final rule amending 10 Background employees and are conducting initial CFR part 95 does not have a significant Regulatory Objective and refresher training of their economic impact on a substantial employees who apply derivative number of small entities. This direct The NRC objective for this final rule classification markings more frequently final rule applies to those licensees who is to require that all cleared employees than every 2 years. The other licensee is generate, receive, safeguard, and store of NRC licensees receive security conducting annual refresher training National Security Information or refresher training on an annual basis. In and training its derivative classifiers at Restricted Data (as defined in 10 CFR addition, all licensee employees who least every 2 years but does not commit part 95). The requirements in this direct apply derivative classification markings to those requirements in its security final rule apply to licensees who operate shall receive training in their derivative program. It is estimated that there will power reactors as well as licensees classification duties prior to derivatively be no one-time cost associated with operating fuel cycle facilities. None of classifying information and at least once amending their licenses through these licensees are ‘‘small entities’’ as every 2 years thereafter. security plan changes since the only defined in the Regulatory Flexibility Act Identification and Preliminary Analysis change is from three years to annually. or the size standards established by the of Alternative Approaches Two of the three licensees have NRC (10 CFR 2.810). This direct final contractors who possess classified rule also applies to contractors of those No-Action Alternative: Under this information and therefore, have their option, the NRC would not amend the licensees required to comply with this own independent security plans. It is direct final rule who generate, receive, current regulations under 10 CFR part estimated that there will also be no one- 95 to require security refresher training safeguard, and store National Security time cost associated with amending Information or Restricted Data (as every year rather than every 3 years. The their licenses through security plan defined in 10 CFR part 95), received or NRC would also not amend the current changes since the only change is from developed in conjunction with activities regulations under 10 CFR part 95 to three years to annually. Since the require training for derivative classifiers majority of the training is administered licensed, certified, or regulated by the prior to derivatively classifying electronically, there is little to no cost Commission. Some of these contractors information and at least once every 2 of preparing and administering the may be ‘‘small entities’’ as defined in years. This option would avoid certain training sessions. Those 10 CFR part 50 the Regulatory Flexibility Act or the costs that the rule will impose. licensees who only access classified NRC’s size standards. However, the However, taking no action would mean information but do not possess it will be impact on these contractors is not that licensees who handle and store impacted minimally from the increase significant because it is the licensees, classified information are not protecting in frequency of security education not the contractors, who are required to that information in accordance with the briefings, since those licensees only offer the training and absorb its costs. requirements the NRC considers have three to five employees who are XII. Backfitting necessary to be consistent with the cleared to access classified information. objectives of Executive Order 13526 to The associated security plan change This direct final rule will apply to all enhance the adequate protection of would merely update the frequency of NRC licensees who receive or possess classified information consistent with refresher training from 3 years to Classified National Security the goal of protecting national security. annually. In addition, none of their Information. The NRC has determined This no-action alternative is the baseline employees are derivative classifiers. that the modifications constitute for this regulatory analysis. Impacts on the NRC: The primary backfitting as defined in 10 CFR 50.109 impact on the NRC will be the resources Estimate and Evaluation of Values and for power reactors, 10 CFR 76.76 for expended in conducting this rulemaking Impacts gaseous diffusion plants, 10 CFR 72.62 and reviewing the amended security Overview: This final rule revises the plans and programs. The staff time to for independent spent fuel storage governing regulations under 10 CFR part review revisions to security plans and installations or monitored retrievable 95 to require licensees to handle programs to ensure commitment to the storage installations, and 10 CFR 70.76 classified information in the same new requirements is minimal. It is for special nuclear material licensees. manner as is required of employees of estimated that this will require no more Consequently, the NRC has prepared the Federal agencies by the Executive than 20 hours and will be accomplished following backfit analysis. The Order. This rulemaking adds value by existing staff as part of their normal Commission has determined that there because it ensures those licensees who workload. will be a substantial increase in the are handling and derivatively marking Impacts on Other Stakeholders: The overall common defense and security classified information are appropriately NRC staff has identified one impact to derived from the backfit, and that the trained in the protection of classified other stakeholders. Those contractors direct and indirect costs that will result information in accordance with current that support licensees who handle from the implementation of the backfit federal standards and requirements. classified information but are not are justified.

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A Statement of the Specific Objectives employees who apply derivative The Potential Impact of Differences in That the Backfit is Designed to Achieve. classification markings more frequently Facility Type, Design, or Age on the The Commission is amending its than every 2 years. The other licensee is Relevance and Practicality of the regulations at 10 CFR 95.33 to update conducting annual refresher training Backfit. the frequency of training requirements and training its derivative classifiers at None. applicable to licensees in order to least every 2 years but does not commit enhance the protection of classified to those requirements in its security Whether the Backfit is Interim or Final information, and to ensure that there is program. It is estimated that there will and, if Interim, the Justification for no discrepancy in the level of protection be no one-time cost associated with Imposing the Backfit on an Interim afforded such information regardless of amending licenses through security plan Basis. whether it is in the possession of the changes since the only change is from The backfit is final. NRC or of its licensees. The objective of three years to annually. Two of the three XIII. Congressional Review Act the backfit is to ensure that protection licensees have contractors who possess of Secret and Confidential National classified information and therefore, Under the Congressional Review Act Security Information and Restricted have their own independent security of 1996, the NRC has determined that Data received or developed in plans. It is estimated that there will also this action is not a major rule and has conjunction with activities licensed, be no one-time cost associated with verified this determination with the certified, or regulated by the amending licenses through security plan Office of Information and Regulatory Commission, in the possession of Affairs of OMB. Commission licensees is enhanced and changes ranges since the only change is is as well protected as such information from three years to annually. Since the List of Subjects in 10 CFR Part 95 would be if it was in the hands of the majority of the training is administered Classified information, Criminal Commission itself. electronically, there is little to no cost penalties, Reporting and recordkeeping of preparing and administering the requirements, Security measures. A General Description of the Activity training sessions. Those 10 CFR part 50 That Would Be Required of the Licensee For the reasons set forth in the licensees who only access classified preamble and under the authority of the or the Applicant To Complete the information but do not posses it will be Backfit. Atomic Energy Act of 1954, as amended; impacted minimally from the increase the Energy Reorganization Act of 1974, Licensee personnel who apply in frequency of security education as amended; and 5 U.S.C. 552 and 553; derivative classification markings will briefings since those licensees only have the NRC is adopting the following receive training in the proper three to five employees who are cleared amendments to 10 CFR part 95. application of the derivative for access to classified information. The classification principles, with an associated security plan change would PART 95—FACILITY SECURITY emphasis on avoiding over- merely update the frequency of refresher CLEARANCE AND SAFEGUARDING classification, at least once every 2 training from 3 years to annually. In OF NATIONAL SECURITY years. In addition, licensees will be addition, none of their employees are INFORMATION AND RESTRICTED required to provide some form of DATA refresher security education and derivative classifiers. training at least annually for all of its The NRC staff has identified one ■ 1. The authority citation for part 95 personnel who handle or generate impact to other stakeholders. Those continues to read as follows: classified information. contractors that support licensees who Authority: Atomic Energy Act Secs. 145, The Potential Change in the Risk to the handle classified information but are 161, 223, 234 (42 U.S.C. 2165, 2201, 2273, Public From the Accidental Offsite not cleared for storage will have to 2282); Energy Reorganization Act sec. 201 (42 Release of Radioactive Material. amend their security plans to change the U.S.C.5841); Government Paperwork frequency of refresher training from 3 Elimination Act sec. 1704 (44 U.S.C. 3504 None. years to annually. These contractors are note); E.O. 10865, as amended, 3 CFR 1959– 1963 Comp., p. 398 (50 U.S.C. 401, note); The Potential Impact on the not required to have derivative E.O. 12829, 3 CFR, 1993 Comp., p. 570; EO Radiological Exposure of Facility classifiers. 13526, 3 CFR 2010 Comp., pp. 298–327; E.O. Employees. The Potential Safety Impact of Changes 12968, 3 CFR, 1995 Comp., p. 391; E.O. 13526, 3 CFR, 2010 Comp., p. 298. None. in Plant or Operational Complexity, ■ 2. Revise § 95.33 to read as follows: The Installation and Continuing Costs Including the Relationship to Proposed Associated With the Backfit, Including and Existing Regulatory Requirements. § 95.33 Security education. the Cost of Facility Downtime or the None. All cleared employees must be Cost of Construction Delay. provided with security training and Impacts upon licensees from this The Estimated Resource Burden on the briefings commensurate with their direct final rule will be minimal. There NRC Associated With the Backfit and involvement with classified are only three 10 CFR part 70 licensees the Availability of NRC Resources. information. The facility official(s) and one Part 76 Certificate holder who responsible for the program shall possess classified information. A fourth The primary impact on the NRC will determine the means and methods for 10 CFR part 70 licensee will be affected be the resources expended in providing security education and later this year when it becomes a conducting this rulemaking and training. A licensee or other entity possessor of classified matter. Of those reviewing the amended security plans subject to part 95 may obtain defensive three, two already commit in their and programs. The staff time to review security, threat awareness, and other internal procedures to annual security revisions to security plans to ensure education and training information and education briefings of all their commitment to the new requirements is material from their Cognizant Security employees and are conducting initial minimal. Agency (CSA) or other appropriate and refresher training of their sources.

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(a) Facility Security Officer Training. employee who has met the standards for DEPARTMENT OF DEFENSE Licensees or other entities subject to access to classified information in part 95 are responsible for ensuring that accordance with paragraph (e) of this Department of the Navy the Facility Security Officer, and other section before the employee is granted personnel performing security duties, access to classified information. The 32 CFR Part 706 complete security training deemed initial training shall include the Certifications and Exemptions Under appropriate by the CSA. Training following topics: requirements must be based on the the International Regulations for facility’s involvement with classified (1) A Threat Awareness Briefing; Preventing Collisions at Sea, 1972 information and may include a Facility (2) A Defensive Security Briefing; AGENCY: Department of the Navy, DoD. Security Officer Orientation Course and, (3) An overview of the security ACTION: Final rule. for Facility Security Officers at facilities classification system; with safeguarding capability, a Facility SUMMARY: The Department of the Navy Security Officer Program Management (4) Employee reporting obligations (DoN) is amending its certifications and Course. Training, if required, should be and requirements; and exemptions under the International completed within 1 year of appointment (5) Security procedures and duties Regulations for Preventing Collisions at to the position of Facility Security applicable to the employee’s job. Sea, 1972 (72 COLREGS), to reflect that Officer. (g) Refresher Briefings. The licensee or the Deputy Assistant Judge Advocate (b) Government-Provided Briefings. General (DAJAG)(Admiralty and The CSA is responsible for providing other entities subject to part 95 shall conduct refresher briefings for all Maritime Law) has determined that USS initial security briefings to the Facility INDEPENDENCE (LCS 2) is a vessel of cleared employees at least annually. As Security Officer, and for ensuring that the Navy which, due to its special a minimum, the refresher briefing must other briefings required for special construction and purpose, cannot fully categories of information are provided. reinforce the information provided comply with certain provisions of the 72 (c) Temporary Help Suppliers. A during the initial briefing and inform COLREGS without interfering with its temporary help supplier, or other employees of appropriate changes in special function as a naval ship. The contractor who employs cleared security regulations. This requirement intended effect of this rule is to warn individuals solely for dispatch may be satisfied by use of audio/video mariners in waters where 72 COLREGS elsewhere, is responsible for ensuring materials and/or by issuing written apply. that required briefings are provided to materials to cleared employees. DATES: This rule is effective August 7, their cleared personnel. The temporary (h) Persons who apply derivative 2013 and is applicable beginning July help supplier or the using licensee’s, classification markings shall receive 24, 2013. certificate holder’s, or other person’s training specific to the proper FOR FURTHER INFORMATION CONTACT: facility may conduct these briefings. (d) Classified Information application of the derivative Lieutenant Jocelyn Loftus-Williams, Nondisclosure Agreement (SF–312). The classification principles of Executive JAGC, U.S. Navy, Admiralty Attorney, SF–312 is an agreement between the Order 13526, Classified National (Admiralty and Maritime Law), Office of United States and an individual who is Security Information (75 FR 707; the Judge Advocate General, Department cleared for access to classified January 5, 2010), before derivatively of the Navy, 1322 Patterson Ave., SE., information. An employee issued an classifying information and at least once Suite 3000, Washington Navy Yard, DC initial access authorization must, in every 2 years thereafter. 20374–5066, telephone number: 202– 685–5040. accordance with the requirements of (i) Debriefings. Licensee and other SUPPLEMENTARY INFORMATION: Pursuant § 25.23 of this chapter, execute an SF– facilities shall debrief cleared to the authority granted in 33 U.S.C. 312 before being granted access to employees at the time of termination of 1605, the DoN amends 32 CFR Part 706. classified information. The Facility employment (discharge, resignation, or Security Officer shall forward the This amendment provides notice that retirement); when an employee’s access the DAJAG (Admiralty and Maritime executed SF–312 to the CSA for authorization is terminated, suspended, retention. If the employee refuses to Law), of the DoN, under authority or revoked; and upon termination of the delegated by the Secretary of the Navy, execute the SF–312, the licensee or Facility Clearance. other facility shall deny the employee has certified that USS INDEPENDENCE access to classified information and (j) Records reflecting an individual’s (LCS 2) is a vessel of the Navy which, submit a report to the CSA. The SF–312 initial and refresher security due to its special construction and must be signed and dated by the orientations and security termination purpose, cannot fully comply with the employee and witnessed. The must be maintained for 3 years after following specific provisions of 72 employee’s and witness’ signatures termination of the individual’s access COLREGS without interfering with its must bear the same date. authorization. special function as a naval ship: Annex I paragraph 2 (a)(i), pertaining to the (e) Access to Classified Information. Dated at Rockville, Maryland, this 23rd day Employees may have access to classified location of the forward masthead light at of July, 2013. a height not less than 12 meters above information only if: For the Nuclear Regulatory Commission. (1) A favorable determination of the hull; Annex I, paragraph 3(a), eligibility for access has been made with R. William Borchardt, pertaining to the location of the forward respect to such employee by the CSA; Executive Director for Operations. masthead light in the forward quarter of (2) The employee has signed an [FR Doc. 2013–18947 Filed 8–6–13; 8:45 am] the ship, and the horizontal distance approved non-disclosure agreement; BILLING CODE 7590–01–P between the forward and after masthead and lights. The DAJAG (Admiralty and (3) The employee has a need-to-know Maritime Law) has also certified that the the information. lights involved are located in closest (f) Initial Security Briefings. Initial possible compliance with the applicable training shall be provided to every 72 COLREGS requirements.

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Moreover, it has been determined, in For the reasons set forth in the ■ 2. Section 706.2 is amended as accordance with 32 CFR Parts 296 and preamble, the DoN amends part 706 of follows: 701, that publication of this amendment title 32 of the Code of Federal ■ A. In Table One by revising the entry for public comment prior to adoption is Regulations as follows: for USS INDEPENDENCE (LCS 2); impracticable, unnecessary, and contrary to public interest since it is PART 706—CERTIFICATIONS AND ■ B. In Table Five, by revising the entry based on technical findings that the EXEMPTIONS UNDER THE for USS INDEPENDENCE (LCS 2). placement of lights on this vessel in a INTERNATIONAL REGULATIONS FOR The revisions read as follows: manner differently from that prescribed PREVENTING COLLISIONS AT SEA, herein will adversely affect the vessel’s 1972 § 706.2 Certifications of the Secretary of ability to perform its military functions. the Navy Under Executive Order 11964 and 33 U.S.C. 1605. List of Subjects in 32 CFR Part 706 ■ 1. The authority citation for part 706 * * * * * Marine safety, Navigation (water), and continues to read as follows: Vessels. Authority: 33 U.S.C. 1605.

TABLE ONE

Distance in meters of forward masthead Vessel Number light below minimum required height § 2(a)(i) annex I

******* USS INDEPENDENCE ...... LCS 2 ...... 4.14

*******

TABLE FIVE

Masthead lights Forward mast- After masthead light less than 1⁄2 not over all other head light not in ship’s length aft of Percentage hori- Vessel Number lights and obstruc- forward quarter of forward masthead zontal separation tions. ship. light. attained annex I, annex I, annex I, sec. 2(f) sec. 3(a) sec. 3(a)

******* USS INDEPENDENCE ...... LCS 2 ...... X X 15.2

Approved: July 24, 2013. DEPARTMENT OF HOMELAND Fireworks. During the enforcement A.B. Fischer, SECURITY period, in accordance with the Captain, JAGC, U.S. Navy, Deputy Assistant established Safety Zone, entry into Judge Advocate General (Admiralty and Coast Guard transiting through or anchoring in the Maritime Law). Safety Zone is prohibited to all vessels 33 CFR Part 165 Dated: July 30, 2013. not registered with the event sponsor as participants or official patrol vessels, D.G. Zimmerman, [Docket No. USCG–2013–0628] unless specifically authorized by the Lieutenant Commander, Office of the Judge Captain of the Port Sector San Diego or Advocate General, U.S. Navy, Alternate Safety Zone; AVI Resort and Casino a designated representative. Federal Register Liaison Officer. Labor Day Fireworks Display; [FR Doc. 2013–19026 Filed 8–6–13; 8:45 am] Colorado River DATES: The regulations in 33 CFR 165.1124, Table 1, Item 4, will be BILLING CODE 3810–FF–P AGENCY: Coast Guard, DHS. enforced from 8 p.m. through 9:45 p.m. ACTION: Notice of enforcement of on September 1, 2013. regulation. FOR FURTHER INFORMATION CONTACT: If SUMMARY: The Coast Guard will enforce you have questions on this notice of a Safety Zone for the AVI Resort and enforcement, call Lieutenant John Casino Labor Day Fireworks Display Bannon, U.S. Coast Guard Sector San located on the Colorado River in Diego at 619–278–7261, or by email at Laughlin, Nevada from 8 p.m. until 9:45 [email protected]. p.m. on September 1, 2013. This action SUPPLEMENTARY INFORMATION: The Coast is necessary for the safety of spectators Guard will enforce the Safety Zone on and participants, including all crews, the Colorado River for the AVI Resort vessels and persons on navigable waters and Casino Labor Day Fireworks during the AVI Resort and Casino Display in 33 CFR 165.1124, Table 1,

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Item 4, from 8 p.m. through 9:45 p.m. Grand Opening of Lindbergh Airport known to the Coast Guard until on September 1, 2013. Terminal Two West on August 8, 2013. recently. Publishing an NPRM would be Under provisions of 33 CFR 165.1124, This temporary safety zone is necessary impracticable because there is a vessel may not enter the regulated to provide for the safety of the insufficient time to hold a comment area, unless it receives permission from participants, crew, spectators, period and immediate action is needed the Captain of the Port or a designated participating vessels, and other vessels to provide for the safety of life and representative. Persons or vessels and users of the waterway. Persons and property on navigable waters. desiring to enter into or pass through vessels are prohibited from entering Under 5 U.S.C. 553(d)(3), the Coast the Safety Zone may request permission into, transiting through, or anchoring Guard finds that good cause exists for from the Captain of the Port or a within this safety zone unless making this rule effective less than 30 designated representative. If permission authorized by the Captain of the Port or days after publication in the Federal is granted, all persons and vessels shall his designated representative. Register because it is impractical and comply with the instructions of the DATES: This rule is effective from 8:30 contrary to the public interest. The Captain of the Port or designated p.m. to 9:15 p.m. on August 8, 2013. Coast Guard did not have the necessary representative. Spectator vessels may ADDRESSES: Documents mentioned in event information in time to provide safely transit outside the regulated area this preamble are part of docket [USCG– both a comment period and allow for a but may not anchor, block, loiter, or 2013–0637]. To view documents 30 day delayed effective date. impede the transit of participants or mentioned in this preamble as being Immediate action is required to ensure official patrol vessels. The Coast Guard available in the docket, go to http:// the safety zone is in place to protect may be assisted by other Federal, State, www.regulations.gov, type the docket participants, crew, spectators, or Local law enforcement agencies in number in the ‘‘SEARCH’’ box and click participating vessels, and other vessels enforcing this regulation. ‘‘SEARCH.’’ Click on Open Docket and users of the waterway during the This notice is issued under authority Folder on the line associated with this event. of 5 U.S.C. 552 (a) and 33 CFR 165.1124. rulemaking. You may also visit the B. Basis and Purpose In addition to this notice in the Federal Docket Management Facility in Room Register, the Coast Guard will provide W12–140 on the ground floor of the The Ports and Waterways Safety Act the maritime community with advance Department of Transportation West gives the Coast Guard authority to create notification of this enforcement period Building, 1200 New Jersey Avenue SE., and enforce safety zones. The Coast via the Local Notice to Mariners and Washington, DC 20590, between 9 a.m. Guard is establishing a temporary safety local advertising by the event sponsor. and 5 p.m., Monday through Friday, zone on the navigable waters of the San If the Captain of the Port Sector San except Federal holidays. Diego Bay for a fireworks event on Diego Patrol Commander or his August 8, 2013, for the San Diego designated representative determines FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or International Airport Terminal Two that the regulated area need not be grand opening. This safety zone is enforced for the full duration stated on email Petty Officer Bryan Gollogly, Waterways Management, U.S. Coast necessary to provide for the safety of the this notice, he or she may use a participants, crew, spectators, sponsor Broadcast Notice to Mariners or other Guard Sector San Diego, Coast Guard; telephone 619–278–7656, email vessels, and other users of the communications coordinated by the waterway. event sponsor to grant general [email protected]. If permission to enter the regulated area. you have questions on viewing or C. Discussion of Comments, Changes submitting material to the docket, call and the Final Rule Dated: July 25, 2013. Barbara Hairston, Program Manager, S.M. Mahoney, Docket Operations, telephone (202) The Coast Guard is establishing a Captain, U.S. Coast Guard, Captain of the 366–9826. safety zone that will be enforced on August 8, 2013, from 8:30 p.m. to 9:15 Port San Diego. SUPPLEMENTARY INFORMATION: [FR Doc. 2013–19100 Filed 8–6–13; 8:45 am] p.m. The limits of the safety zone will be navigable waters of the San Diego BILLING CODE 9110–04–P Table of Acronyms Bay. The limits of the safety zone will DHS Department of Homeland Security FR Federal Register include all the navigable waters within DEPARTMENT OF HOMELAND NPRM Notice of Proposed Rulemaking 600 feet of the nearest point of the SECURITY fireworks barge in approximate position A. Regulatory History and Information 32 42′ 46.71″ N 117 10′ 39.44″ W. Coast Guard The Coast Guard is issuing this final This safety zone is necessary to rule without prior notice and ensure unauthorized personnel and 33 CFR Part 165 opportunity to comment pursuant to vessels remain safe by keeping clear [Docket No. USCG–2013–0637] authority under section 4(a) of the during the fireworks show. Persons and Administrative Procedure Act (APA) (5 vessels are prohibited from entering RIN 1625–AA00 U.S.C. 553(b)). This provision into, transiting through, or anchoring authorizes an agency to issue a rule within this safety zone unless Safety Zone; San Diego International without prior notice and opportunity to authorized by the Captain of the Port, or Airport Terminal Two West Grand comment when the agency for good his designated representative. Opening Fireworks; San Diego, CA cause finds that those procedures are Before the effective period, the Coast AGENCY: Coast Guard, DHS. ‘‘impracticable, unnecessary, or contrary Guard will publish a Coast Guard ACTION: Temporary final rule. to the public interest.’’ Under 5 U.S.C. District Eleven Local Notice to Mariners 553(b)(B), the Coast Guard finds that information on the event and associated SUMMARY: The Coast Guard is good cause exists for not publishing a safety zone. Immediately before and establishing a safety zone on the notice of proposed rulemaking (NPRM) during the fireworks event, Coast Guard navigable waters of the San Diego Bay with respect to this rule because the Sector San Diego Joint Harbor in support of a fireworks display for the final details of the event were not Operations Center will issue Broadcast

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Notice to Mariners on the location and (2) This safety zone will not have a jeopardizing the safety or security of enforcement of the safety zone. significant economic impact on a people, places or vessels. Vessels will be able to transit the substantial number of small entities for 7. Unfunded Mandates Reform Act surrounding area and may be authorized the following reasons: The safety zone to transit through the safety zone with will only be in effect for forty five The Unfunded Mandates Reform Act the permission of the Captain of the Port minutes late in the evening when vessel of 1995 (2 U.S.C. 1531–1538) requires of the designated representative. Before traffic is low. Vessel traffic can safely Federal agencies to assess the effects of activating the zones, the Coast Guard transit around the safety zone while the their discretionary regulatory actions. In will notify mariners by appropriate zone is in effect. particular, the Act addresses actions means including but not limited to that may result in the expenditure by a 3. Assistance for Small Entities Local Notice to Mariners and Broadcast State, local, or tribal government, in the Notice to Mariners. Under section 213(a) of the Small aggregate, or by the private sector of Business Regulatory Enforcement D. Regulatory Analyses $100,000,000 (adjusted for inflation) or Fairness Act of 1996 (Public Law 104– more in any one year. Though this rule We developed this rule after 121), we want to assist small entities in will not result in such an expenditure, considering numerous statutes and understanding this rule. If the rule we do discuss the effects of this rule executive orders related to rulemaking. would affect your small business, elsewhere in this preamble. Below we summarize our analyses organization, or governmental based on a number of these statutes and jurisdiction and you have questions 8. Taking of Private Property executive orders. concerning its provisions or options for This rule will not cause a taking of 1. Regulatory Planning and Review compliance, please contact the person private property or otherwise have listed in the FOR FURTHER INFORMATION This rule is not a significant taking implications under Executive CONTACT, above. Order 12630, Governmental Actions and regulatory action under section 3(f) of Small businesses may send comments Executive Order 12866, Regulatory Interference with Constitutionally on the actions of Federal employees Protected Property Rights. Planning and Review, as supplemented who enforce, or otherwise determine by Executive Order 13563, Improving compliance with, Federal regulations to 9. Civil Justice Reform Regulation and Regulatory Review, and the Small Business and Agriculture This rule meets applicable standards does not require an assessment of Regulatory Enforcement Ombudsman potential costs and benefits under in sections 3(a) and 3(b)(2) of Executive and the Regional Small Business Order 12988, Civil Justice Reform, to section 6(a)(3) of Executive Order 12866 Regulatory Fairness Boards. The or under section 1 of Executive Order minimize litigation, eliminate Ombudsman evaluates these actions ambiguity, and reduce burden. 13563. The Office of Management and annually and rates each agency’s Budget has not reviewed it under those responsiveness to small business. If you 10. Protection of Children Orders. This determination is based on wish to comment on actions by the size, duration and location of the We have analyzed this rule under employees of the Coast Guard, call 1– Executive Order 13045, Protection of safety zone. The safety zone is relatively 888–REG–FAIR (1–888–734–3247). The small in size, less than half a mile Children from Environmental Health Coast Guard will not retaliate against Risks and Safety Risks. This rule is not across, short in duration, 45 minutes small entities that question or complain long, and traffic would be allowed to an economically significant rule and about this rule or any policy or action does not create an environmental risk to pass through the zone with the of the Coast Guard. permission of the Captain of the Port. health or risk to safety that may Additionally, before the effective 4. Collection of Information disproportionately affect children. period, the Coast guard will publish a This rule will not call for a new 11. Indian Tribal Governments Local Notice to Mariners. collection of information under the This rule does not have tribal 2. Impact on Small Entities Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). implications under Executive Order The Regulatory Flexibility Act of 1980 13175, Consultation and Coordination (RFA), 5 U.S.C. 601–612, as amended, 5. Federalism with Indian Tribal Governments, requires federal agencies to consider the A rule has implications for federalism because it does not have a substantial potential impact of regulations on small under Executive Order 13132, direct effect on one or more Indian entities during rulemaking. The term Federalism, if it has a substantial direct tribes, on the relationship between the ‘‘small entities’’ comprises small effect on the States, on the relationship Federal Government and Indian tribes, businesses, not-for-profit organizations between the national government and or on the distribution of power and that are independently owned and the States, or on the distribution of responsibilities between the Federal operated and are not dominant in their power and responsibilities among the Government and Indian tribes. fields, and governmental jurisdictions various levels of government. We have 12. Energy Effects with populations of less than 50,000. analyzed this rule under that Order and The Coast Guard certifies under 5 U.S.C. determined that this rule does not have This action is not a ‘‘significant 605(b) that this rule will not have a implications for federalism. energy action’’ under Executive Order significant economic impact on a 13211, Actions Concerning Regulations substantial number of small entities. 6. Protest Activities That Significantly Affect Energy Supply, (1) This rule will affect the following The Coast Guard respects the First Distribution, or Use. entities, some of which may be small Amendment rights of protesters. 13. Technical Standards entities: the owners or operators of Protesters are asked to contact the vessels intending to transit or anchor in person listed in the FOR FURTHER This rule does not use technical the impacted portion of the San Diego INTFORMATION CONTACT section to standards. Therefore, we did not Bay on August 8, 2013 between 8:30 coordinate protest activities so that your consider the use of voluntary consensus p.m. and 9:15 p.m. message can be received without standards.

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14. Environment zone is prohibited unless authorized by Washington, DC 20590, between 9 a.m. We have analyzed this rule under the Captain of the Port of San Diego or and 5 p.m., Monday through Friday, Department of Homeland Security his designated representative. except Federal holidays. Management Directive 023–01 and (2) All persons and vessels shall FOR FURTHER INFORMATION CONTACT: If Commandant Instruction M16475.lD, comply to the instructions of the Coast you have questions on this rule, call or which guide the Coast Guard in Guard Captain of the Port of his email Petty Officer First Class Bryan complying with the National designated representative. Gollogly, Waterways Management, U.S. (3) Upon being hailed by U.S. Coast Environmental Policy Act of 1969 Coast Guard Sector San Diego, Coast Guard patrol personnel by siren, radio, (NEPA)(42 U.S.C. 4321–4370f), and Guard; telephone 619–278–7656, email a flashing light, or other means, the have determined that this action is one [email protected]. If operator of a vessel shall proceed as of a category of actions that do not you have questions on viewing or directed. submitting material to the docket, call individually or cumulatively have a (4) The Coast Guard may be assisted Barbara Hairston, Program Manager, significant effect on the human by other federal, state, or local agencies. environment. This rule involves Docket Operations, telephone (202) establishment of a safety zone. This rule Dated: July 25, 2013. 366–9826. is categorically excluded from further S.M. Mahoney, SUPPLEMENTARY INFORMATION: review under paragraph 34(g) of Figure Captain, U.S. Coast Guard. Captain of the 2–1 of the Commandant Instruction. An Port San Diego. Table of Acronyms environmental analysis checklist [FR Doc. 2013–18985 Filed 8–6–13; 8:45 am] DHS Department of Homeland Security supporting this determination and a BILLING CODE 9110–04–P FR Federal Register Categorical Exclusion Determination are NPRM Notice of Proposed Rulemaking available in the docket where indicated A. Regulatory History and Information under ADDRESSES. DEPARTMENT OF HOMELAND SECURITY The Coast Guard is issuing this List of Subjects in 33 CFR Part 165 temporary final rule without prior Harbors, Marine safety, Navigation Coast Guard notice and opportunity to comment (water), Reporting and recordkeeping pursuant to authority under section 4(a) requirements, Security Measures, 33 CFR Part 165 of the Administrative Procedure Act Waterways. [Docket No. USCG–2013–0666] (APA) (5 U.S.C. 553(b)). This provision For the reasons discussed in the authorizes an agency to issue a rule preamble, the Coast Guard amends 33 RIN 1625–AA00 without prior notice and opportunity to CFR part 165 as follows: Safety Zone; Kuoni Destination comment when the agency for good Management Fireworks; San Diego, CA cause finds that those procedures are PART 165—REGULATED NAVIGATION ‘‘impracticable, unnecessary, or contrary AREAS AND LIMITED ACCESS AREAS AGENCY: Coast Guard, DHS. to the public interest.’’ Under 5 U.S.C. ACTION: 553(b)(B), the Coast Guard finds that ■ 1. The authority citation for part 165 Temporary final rule. good cause exists for not publishing an continues to read as follows: SUMMARY: The Coast Guard is NPRM with respect to this rule because Authority: 33 U.S.C. 1231; 46 U.S.C. establishing a safety zone on the doing so would be impracticable. The Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; navigable waters of the San Diego Bay final details for this event were not 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; in support of the Kuoni Destination received by the Coast Guard with Pub. L. 107–295, 116 Stat. 2064; Department Management Fireworks Display on of Homeland Security Delegation No. 0170.1. sufficient time to publish an NPRM. August 6, 2013. This temporary safety Thus, delaying this rule to wait for a ■ 2. Add § 165.T11–582 to read as zone is necessary to provide for the comment period to run would be follows: safety of the participants, crew, impracticable because it would inhibit spectators, participating vessels, and § 165.T11–582 Safety Zone; San Diego the Coast Guard’s ability to protect the International Airport Terminal Two West other vessels and users of the waterway. public from the potential hazards Grand Opening Fireworks; San Diego, CA Persons and vessels are prohibited from associated with fireworks displays. entering into, transiting through, or (a) Location. The limits of the safety Immediate action is required to ensure anchoring within this safety zone unless zone will include all the navigable the safety zone is in place to protect authorized by the Captain of the Port or waters within 600 feet of the nearest participants, crew, spectators, his designated representative. point of the fireworks barge in participating vessels, and other vessels approximate position 32 42′ 46.71″ N DATES: This rule is effective from 8:30 and users of the waterway during the 117 10′ 39.44″ W. p.m. to 9:15 p.m. on August 6, 2013. event. ADDRESSES: Documents mentioned in (b) Enforcement Period. This section B. Basis and Purpose will be enforced from 8:30 p.m. to 9:15 this preamble are part of docket [USCG– p.m. on August 8, 2013. 2013–0666]. To view documents The Ports and Waterways Safety Act (c) Definitions. The following mentioned in this preamble as being gives the Coast Guard authority to create definition applies to this section: available in the docket, go to http:// and enforce safety zones. The Coast designated representative means any www.regulations.gov, type the docket Guard is establishing a temporary safety commissioned, warrant, or petty officer number in the ‘‘SEARCH’’ box and click zone on the navigable waters of the San of the Coast Guard on board Coast ‘‘SEARCH.’’ Click on Open Docket Diego Bay for the Kuoni Destination Guard, Coast Guard Auxiliary, and Folder on the line associated with this Management fireworks event on August local, state, and federal law enforcement rulemaking. You may also visit the 6, 2013. This safety zone is necessary to vessels who have been authorized to act Docket Management Facility in Room provide for the safety of the on the behalf of the Captain of the Port. W12–140 on the ground floor of the participants, crew, spectators, sponsor (d) Regulations. (1) Entry into, transit Department of Transportation West vessels, and other users of the through or anchoring within this safety Building, 1200 New Jersey Avenue SE., waterway.

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C. Discussion of Comments, Changes pass through the zone with the about this rule or any policy or action and the Final Rule permission of the Captain of the Port. of the Coast Guard. Additionally, before the effective The Coast Guard is establishing a 4. Collection of Information safety zone that will be enforced on period, the Coast Guard will publish a This rule will not call for a new August 6, 2013, from 8:30 p.m. to 9:15 Local Notice to Mariners. collection of information under the p.m. The limits of the safety zone will 2. Impact on Small Entities Paperwork Reduction Act of 1995 (44 be the navigable waters of San Diego U.S.C. 3501–3520). Bay within 500 feet of the tug and barge, The Regulatory Flexibility Act of 1980 located approximately 550 feet off of the (RFA), 5 U.S.C. 601–612, as amended, 5. Federalism requires federal agencies to consider the San Diego Broadway Pier at position: A rule has implications for federalism 32°42′56.20″ N, 117°10′39.36″ W. potential impact of regulations on small entities during rulemaking. The term under Executive Order 13132, This safety zone is necessary to Federalism, if it has a substantial direct ensure unauthorized personnel and ‘‘small entities’’ comprises small businesses, not-for-profit organizations effect on the States, on the relationship vessels remain safe by keeping clear between the national government and during the fireworks show. Persons and that are independently owned and operated and are not dominant in their the States, or on the distribution of vessels would be prohibited from power and responsibilities among the entering into, transiting through, or fields, and governmental jurisdictions with populations of less than 50,000. various levels of government. We have anchoring within this safety zone unless analyzed this rule under that Order and authorized by the Captain of the Port, or The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a determined that this rule does not have his designated representative. implications for federalism. Before the effective period, the Coast significant economic impact on a Guard will publish a Coast Guard substantial number of small entities. 6. Protest Activities District Eleven Local Notice to Mariners (1) This rule will affect the following entities, some of which may be small The Coast Guard respects the First information on the event and associated Amendment rights of protesters. safety zone. Immediately before and entities: The owners or operators of vessels intending to transit or anchor in Protesters are asked to contact the during the fireworks event, Coast Guard FOR FURTHER the impacted portion of the San Diego person listed in the Sector San Diego Joint Harbor INFORMATION CONTACT section to Operations Center will issue Broadcast Bay on August 6, 2013, between 8:30 p.m. and 9:15 p.m. coordinate protest activities so that your Notice to Mariners on the location and message can be received without (2) This safety zone will not have a enforcement of the safety zone. jeopardizing the safety or security of significant economic impact on a Vessels will be able to transit the people, places or vessels. surrounding area and may be authorized substantial number of small entities for to transit through the safety zone with the following reasons: The safety zone 7. Unfunded Mandates Reform Act the permission of the Captain of the Port will only be in effect for forty five The Unfunded Mandates Reform Act of the designated representative. Before minutes late in the evening when vessel of 1995 (2 U.S.C. 1531–1538) requires activating the zones, the Coast Guard traffic is low. Vessel traffic can safely Federal agencies to assess the effects of will notify mariners by appropriate transit around the safety zone while the their discretionary regulatory actions. In means including but not limited to zone is in effect. particular, the Act addresses actions Local Notice to Mariners and Broadcast 3. Assistance for Small Entities that may result in the expenditure by a Notice to Mariners. State, local, or tribal government, in the Under section 213(a) of the Small D. Regulatory Analyses aggregate, or by the private sector of Business Regulatory Enforcement $100,000,000 (adjusted for inflation) or We developed this rule after Fairness Act of 1996 (Pub. L. 104–121), more in any one year. Though this rule considering numerous statutes and we want to assist small entities in will not result in such an expenditure, executive orders related to rulemaking. understanding this rule. If the rule we do discuss the effects of this rule Below we summarize our analyses would affect your small business, elsewhere in this preamble. based on a number of these statutes and organization, or governmental executive orders. jurisdiction and you have questions 8. Taking of Private Property concerning its provisions or options for 1. Regulatory Planning and Review This rule will not cause a taking of compliance, please contact the person private property or otherwise have This rule is not a significant listed in the FOR FURTHER INFORMATION taking implications under Executive regulatory action under section 3(f) of CONTACT, above. Order 12630, Governmental Actions and Executive Order 12866, Regulatory Small businesses may send comments Interference with Constitutionally Planning and Review, as supplemented on the actions of Federal employees Protected Property Rights. by Executive Order 13563, Improving who enforce, or otherwise determine Regulation and Regulatory Review, and compliance with, Federal regulations to 9. Civil Justice Reform does not require an assessment of the Small Business and Agriculture This rule meets applicable standards potential costs and benefits under Regulatory Enforcement Ombudsman in sections 3(a) and 3(b)(2) of Executive section 6(a)(3) of Executive Order 12866 and the Regional Small Business Order 12988, Civil Justice Reform, to or under section 1 of Executive Order Regulatory Fairness Boards. The minimize litigation, eliminate 13563. The Office of Management and Ombudsman evaluates these actions ambiguity, and reduce burden. Budget has not reviewed it under those annually and rates each agency’s Orders. This determination is based on responsiveness to small business. If you 10. Protection of Children the size, duration and location of the wish to comment on actions by We have analyzed this rule under safety zone. The safety zone is relatively employees of the Coast Guard, call 1– Executive Order 13045, Protection of small in size, less than half a mile 888–REG–FAIR (1–888–734–3247). The Children from Environmental Health across, short in duration, 45 minutes Coast Guard will not retaliate against Risks and Safety Risks. This rule is not long, and traffic would be allowed to small entities that question or complain an economically significant rule and

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does not create an environmental risk to Authority: 33 U.S.C. 1231; 46 U.S.C. programs authorized under Title IV of health or risk to safety that may Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; the Higher Education Act of 1965, as disproportionately affect children. 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; amended (Title IV, HEA programs). The Pub. L. 107–295, 116 Stat. 2064; Department amended regulations implement the 11. Indian Tribal Governments of Homeland Security Delegation No. 0170.1. Office of Hearings & Appeals (OHA) This rule does not have tribal ■ 2. Add § 165.T11–583 to read as Electronic Filing System, which implications under Executive Order follows: provides a Web-based interface for the submission of documents in 13175, Consultation and Coordination § 165.T11–583 Safety Zone; Kuoni with Indian Tribal Governments, Destination Management Fireworks; San administrative litigation involving because it does not have a substantial Diego, CA. enforcement and compliance with requirements of Title IV, HEA programs. direct effect on one or more Indian (a) Location. The limits of the safety The OHA Electronic Filing System tribes, on the relationship between the zone will include all the navigable (OES) permits documents to be Federal Government and Indian tribes, waters within 500 feet of the nearest submitted electronically in an Adobe or on the distribution of power and point of the fireworks barge in Portable Document Format (PDF) responsibilities between the Federal approximate position 32°42′56.20″ N Government and Indian tribes. ° ′ ″ directly to OHA through standard Web- 117 10 39.36 W. based screens and prompts. 12. Energy Effects (b) Enforcement Period. This section will be enforced from 8:30 p.m. to 9:15 DATES: These regulations are effective This action is not a ‘‘significant p.m. on August 6, 2013. August 7, 2013. energy action’’ under Executive Order (c) Definitions. The following FOR FURTHER INFORMATION CONTACT: 13211, Actions Concerning Regulations definition applies to this section: Frank Furey, Director, Office of That Significantly Affect Energy Supply, Designated representative means any Hearings & Appeals, U.S. Department of Distribution, or Use. commissioned, warrant, or petty officer Education, 400 Maryland Avenue SW., Washington, DC 20202–4616. 13. Technical Standards of the Coast Guard on board Coast Guard, Coast Guard Auxiliary, and Telephone: (202) 619–9700. This rule does not use technical local, state, and federal law enforcement If you use a telecommunications standards. Therefore, we did not vessels who have been authorized to act device for the deaf (TDD) or a text consider the use of voluntary consensus on the behalf of the Captain of the Port. telephone (TTY), call the Federal Relay standards. (d) Regulations. (1) Entry into, transit Service (FRS), toll free, at 1–800–877– 8339. 14. Environment through or anchoring within this safety zone is prohibited unless authorized by SUPPLEMENTARY INFORMATION: These We have analyzed this rule under the Captain of the Port of San Diego or regulations implement changes Department of Homeland Security his designated representative. governing filing procedures in Management Directive 023–01 and (2) All persons and vessels shall proceedings before the OHA. The Commandant Instruction M16475.lD, comply to the instructions of the Coast changes allow parties participating in which guide the Coast Guard in Guard Captain of the Port of his administrative adjudications involving complying with the National designated representative. Title IV, HEA programs to file Environmental Policy Act of 1969 (3) Upon being hailed by U.S. Coast documents electronically. The changes (NEPA) (42 U.S.C. 4321–4370f), and Guard patrol personnel by siren, radio, include removing the requirement that have determined that this action is one a flashing light, or other means, the evidence must be filed at the time a of a category of actions that do not operator of a vessel shall proceed as postsecondary institution or third-party individually or cumulatively have a directed. servicer files a request for review of a significant effect on the human (4) The Coast Guard may be assisted final audit determination or a final environment. This rule involves by other federal, state, or local agencies. program review determination. The establishment of a safety zone. This rule Dated: July 25, 2013. Secretary modified this requirement by is categorically excluded from further S.M. Mahoney, holding that evidence filed after a review under paragraph 34(g) of Figure Captain, U.S. Coast Guard, Captain of the request for review is filed may be 2–1 of the Commandant Instruction. An Port San Diego. considered by the hearing official, environmental analysis checklist [FR Doc. 2013–18986 Filed 8–6–13; 8:45 am] notwithstanding the rule codified by 34 supporting this determination and a CFR 668.116(e). See, In re Baytown BILLING CODE 9110–04–P Categorical Exclusion Determination are Technical School, Inc., Docket No. 91– available in the docket where indicated 40–SP, U.S. Dep’t of Educ. (April 12, under ADDRESSES. 1994). For nearly two decades, the DEPARTMENT OF EDUCATION List of Subjects in 33 CFR Part 165 Department’s hearings officials have 34 CFR Part 668 followed the Secretary’s decision. This Harbors, Marine safety, Navigation revision brings the regulations into (water), Reporting and recordkeeping RIN 1880–AA87 conformity with the Secretary’s ruling. requirements, Security measures, The amended regulations also remove Waterways. Student Assistance General Provisions a requirement imposed by existing For the reasons discussed in the AGENCY: Office of Hearings & Appeals, regulations mandating that certain preamble, the Coast Guard amends 33 Office of Management, Department of filings be submitted by hand delivery or CFR part 165 as follows: Education. certified mail. The new procedures offer ACTION: Final regulations. litigants an alternative to using current PART 165—REGULATED NAVIGATION paper-based procedures for the AREAS AND LIMITED ACCESS AREAS SUMMARY: The Secretary amends the submission of documents. The amended Student Assistance General Provisions regulations allow any filing to be ■ 1. The authority citation for part 165 regulations governing participation in submitted to OHA electronically by use continues to read as follows: the student financial assistance of the OES, which is a Web-based

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interface that is accessible 24 hours proposed regulations. These regulations referred to as an ‘‘economically every day. The OES provides allow for electronic filing of documents significant’’ rule); administrative litigants with an in actions before the OHA, and they (2) Create serious inconsistency or acknowledgement of receipt of filings remove a deadline for filing evidence otherwise interfere with an action taken and records at the time of submission. when a party requests review of a final or planned by another agency; The OES generates email notifications audit determination or a final program (3) Materially alter the budgetary when a document filed electronically review determination. As such, these impacts of entitlement grants, user fees, has been received and has been regulations make procedural changes or loan programs or the rights and accepted. only and do not establish substantive obligations of recipients thereof; or To use the OES, a party must notify policy. The revised regulations are (4) Raise novel legal or policy issues OHA and the opposing party of its therefore rules of agency practice and arising out of legal mandates, the intention to submit filings electronically procedure, and the APA does not President’s priorities, or the principles through OES. Each party is free to elect require notice and comment rulemaking stated in the Executive order. to use the OES filing system, and may here. See, Bachow Communications Inc. This final regulatory action is not a decline to do so. The regulations require v. FCC, 237 F.3d 683, 690 (D.C. Cir. significant regulatory action subject to each party to deliver a copy of any filing 2001) (rules governing an application review by OMB under section 3(f) of to the opposing party. If both parties process are ‘‘rules of agency Executive Order 12866. have notified OHA and each other of organization, procedure, or practice’’ We have also reviewed these their intent to use the OES, the parties and exempt from the APA’s notice and regulations under Executive Order may satisfy both their obligation to comment requirement); see also, Merck 13563, which supplements and submit a filing to OHA as well as their & Co., Inc. v. Kessler, 80 F.3d 1543, 1549 explicitly reaffirms the principles, obligation to deliver a copy of any filing (Fed. Cir. 1996) (holding that rules of structures, and definitions governing to the opposing party simply by filing practice are not substantive rules to regulatory review established in that document with OHA through the which notice and comment would Executive Order 12866. To the extent OES and obtaining confirmation of its apply). permitted by law, Executive Order acceptance. The OES generates notice to 13563 requires that an agency— the opposing party that the document so In addition, the Secretary has decided (1) Propose or adopt regulations only filed has been accepted and is available to waive the 30-day delay in the on a reasoned determination that their on the OES. No further action is needed effective date of these regulatory benefits justify their costs (recognizing to serve a copy of that filing with the changes under 5 U.S.C. 553(d)(3). It is that some benefits and costs are difficult opposing party. unnecessary because here ‘‘the to quantify); If, however, a party who wishes to file administrative rule is a routine (2) Tailor its regulations to impose the through the OES has not received an determination, insignificant in nature least burden on society, consistent with affirmative agreement by the opposing and impact, and inconsequential to the obtaining regulatory objectives and party to use the OES, the party that files industry and to the public.’’ Mack taking into account—among other things through the OES must, as under current Trucks v. EPA, 682 F.3d 87, 94 (D.C. Cir. and to the extent practicable—the costs regulations, deliver a copy of the filing 2012). The 30-day delay is unnecessary of cumulative regulations; to the opposing party by mail, by because we have merely broadened the (3) In choosing among alternative facsimile transmission, or by hand- way the public may file papers, adding regulatory approaches, select those delivery. In addition, the parties are free electronic filing to the other options that approaches that maximize net benefits to agree to meet their respective already existed. This is a ministerial (including potential economic, obligations by any other means, change that requires no change in environmental, public health and safety, including transmitting the filing directly behavior by the public. For the same and other advantages; distributive by email or other electronic means. reasons, the Secretary has determined, impacts; and equity); Unless a party affirmatively notifies the under section 492(b)(2) of the HEA, 20 (4) To the extent feasible, specify opposing party that it also chooses to U.S.C. 1098a(b)(2), that these performance objectives, rather than the use the OES, the party that elects to file regulations should not be subject to behavior or manner of compliance a by means of the OES must ensure that negotiated rulemaking. regulated entity must adopt; and (5) Identify and assess available any filing it makes through the OES is Executive Orders 12866 and 13563 delivered to the non-electing party by alternatives to direct regulation, mail, by facsimile transmission, or by Regulatory Impact Analysis including economic incentives—such as hand-delivery, as required under user fees or marketable permits—to Under Executive Order 12866, the existing regulations. encourage the desired behavior, or Secretary must determine whether this Furthermore, a party who chooses to provide information that enables the regulatory action is ‘‘significant’’ and, file electronically through the OES may public to make choices. therefore, subject to the requirements of do so for some or all filings in the Executive Order 13563 also requires the Executive order and subject to matter. For those filings not made an agency ‘‘to use the best available review by the Office of Management and through the OES, the party must meet techniques to quantify anticipated Budget (OMB). Section 3(f) of Executive all requirements in current regulations present and future benefits and costs as Order 12866 defines a ‘‘significant for filing with OHA and delivering accurately as possible.’’ The Office of regulatory action’’ as an action likely to copies to the opposing party. Information and Regulatory Affairs of result in a rule that may— OMB has emphasized that these Waiver of Proposed Rulemaking, (1) Have an annual effect on the techniques may include ‘‘identifying Negotiated Rulemaking, and Delayed economy of $100 million or more, or changing future compliance costs that Effective Date adversely affect a sector of the economy, might result from technological Under the Administrative Procedure productivity, competition, jobs, the innovation or anticipated behavioral Act (5 U.S.C. 553) (APA), the environment, public health or safety, or changes.’’ Department generally offers interested State, local, or tribal governments or We are issuing these regulations only parties the opportunity to comment on communities in a material way (also on a reasoned determination that their

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benefits justify their costs. In choosing Assessment of Educational Impact ■ A. Revising paragraphs (a)(1) and (4). ■ among alternative regulatory Based on our review, we have B. Adding paragraphs (a)(5), (a)(6), approaches, we selected those determined that these final regulations and (b)(2)(v). approaches that maximize net benefits. do not require transmission of The revisions and additions read as Based on the analysis that follows, the information that any other agency or follows: Department believes that these final authority of the United States gathers or § 668.91 Filing of requests for hearings regulations are consistent with the makes available. and appeals; confirmation of mailing and principles in Executive Order 13563. Accessible Format: Individuals with receipt dates. We also have determined that this disabilities can obtain this document in (a) * * * regulatory action would not unduly an accessible format (e.g., braille, large (1)(i) A request by an institution or interfere with State, local, or tribal print, audiotape, or compact disc) on third-party servicer for a hearing or governments in the exercise of their request to the program contact person show-cause opportunity, or other governmental functions. listed under FOR FURTHER INFORMATION material submitted by an institution or CONTACT. third-party servicer in response to a In accordance with both Executive Electronic Access to This Document: notice of proposed action under this orders, the Department has assessed the The official version of this document is subpart, must be filed with the potential costs and benefits, both the document published in the Federal designated department official by hand- quantitative and qualitative, of this Register. Free Internet access to the delivery, mail, or facsimile regulatory action. The potential costs official edition of the Federal Register transmission. associated with this regulatory action and the Code of Federal Regulations is (ii) An appeal to the Secretary by a are those resulting from statutory available via the Federal Digital System party must be filed with the designated requirements and those we have at: www.gpo.gov/fdsys. At this site you department official by hand-delivery, determined as necessary for can view this document, as well as all mail, facsimile transmission, or by use administering the Department’s other documents of this Department of the Office of Hearings and Appeals programs and activities. However, there published in the Federal Register, in Electronic Filing System (OES). are no identifiable or measurable costs text or Adobe Portable Document * * * * * expected. The benefit of these Format (PDF). To use PDF you must (4)(i) A party may file an appeal to the regulations is that parties will now have have Adobe Acrobat Reader, which is Secretary, and any other pleading or the option of filing documents available free at www.gpo.gov/fdsys. other document submitted in a electronically. You may also access documents of the proceeding under this subpart, by use of Department published in the Federal Regulatory Flexibility Act the Office of Hearings and Appeals Register by using the article search Electronic Filing System (OES), by The Secretary certifies that these feature at: www.federalregister.gov. hand-delivery, by mail, or by facsimile regulations do not have a significant Specifically, through the advanced transmission. economic impact on a substantial search feature at this site, you can limit (ii) A party must serve a copy on the number of small entities. The small your search to documents published by other party of any pleading or other entities that could be affected by these the Department. document it files, including an appeal to regulations are small postsecondary (Catalog of Federal Domestic Assistance the Secretary, in a proceeding under this institutions. These regulations do not Number: 84.268, Federal Direct Student subpart. A party must do so by certified have a significant economic impact on Loans) mail, return receipt requested; by hand- these small entities because the delivery; or, if agreed upon by the regulations provide a voluntary, List of Subjects in 34 CFR Part 668 parties, service may also be made by use alternative means of filing documents in Administrative practice and of the OES or any other means agreed addition to the current methods, which procedure, Aliens, Colleges and to by the parties. remain available to all parties, including universities, Consumer protection, (iii) A party who agrees to receive a small postsecondary institutions. The Grant programs—education, Loan document by any means other than amended regulations impose minimal programs—education, Reporting and service by certified mail, return receipt requirements to ensure the proper recordkeeping requirements, Selective requested or hand-delivery may limit expenditure of student financial Service System, Student aid, Vocational that agreement to one or more particular assistance program funds. education. documents. (iv) A party who agrees to service of Paperwork Reduction Act of 1995 Dated: August 2, 2013. a document through the OES thereby Arne Duncan, agrees that the notice of such filing Sections 668.98, 668.113, and 668.124 Secretary of Education. provided to the party by the OES contain information collection For the reasons discussed, the suffices to meet any obligation of the requirements that have already been Secretary amends part 668 of title 34 of filing party under these regulations to approved by OMB. The changes in these the Code of Federal Regulations as provide a copy of that document. final regulations do not alter those follows: (5) Documents filed using the OES approved information collection must be transmitted to the designated requirements. Therefore, the PART 668—STUDENT ASSISTANCE department official identified in Department will not need to submit a GENERAL PROVISIONS instructions provided by the hearing copy of those sections to OMB for its official as the individual responsible to review (44 U.S.C. 3504(h)). ■ 1. The authority citation for part 668 is revised to read as follows: receive them. A party filing a document Intergovernmental Review using the OES must ensure that the Authority: 20 U.S.C. 1001–1003, 1070g, party has received an electronic These programs are not subject to the 1085, 1088, 1091, 1092, 1094, 1099c, and confirmation that the document was 1099c-1, unless otherwise noted. requirements of Executive Order 12372 accepted and approved for filing by the and the regulations in 34 CFR part 79. ■ 2. Section 668.91 is amended by: OES, and may be required by the

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designated department official to (ii) In the case of an institution, § 668.124 Interlocutory appeals to the provide a hard copy of the document. institutional audit work papers, records, Secretary from rulings of a hearing official. (6) Electronic documents must be and other materials. * * * * * formatted in Adobe Portable Document (iii) In the case of a third-party (c) A copy of the petition must be Format (PDF). To use PDF you must servicer, the servicer’s audit work provided to the hearing official at the have Adobe Acrobat Reader, which is papers and the records and other time of filing with the Secretary, and a available free at www.adobe.com. materials of the servicer or any copy of a petition or any certification (b) * * * institution that contracts with the must be served upon the parties as (2) * * * servicer. provided in § 668.122(a)(2). The petition (v) The date a document sent * * * * * or certification must reflect this service. electronically via the OES is recorded as (d) If a party files a petition under this (v) Institutional or servicer records received by the OES as indicated in the section, the hearing official may state to and other materials (including records confirmation of receipt email for E- the Secretary a view as to whether and other materials of any institution filing. review is appropriate or inappropriate that contracts with the servicer) by submitting a brief statement * * * * * provided to the Department of addressing the party’s petition within 10 ■ 3. Section 668.98 is amended by Education in response to a program days of the receipt of that petition by the revising paragraphs (c), (d), and (e) to review. read as follows: hearing official. A copy of the statement (vi) Other Department of Education must be served on all parties in the § 668.98 Interlocutory appeals to the records and materials. manner provided in § 668.122(a)(2). Secretary from rulings of a hearing official. * * * * * (e) A party’s response to a petition or * * * * * ■ 6. Section 668.122 is amended by certification for interlocutory review (c) A copy of the petition must be revising paragraphs (a) and (c) to read as must be filed within 7 days after service provided to the hearing official at the follows: of the petition or statement, as time of filing with the Secretary, and a applicable, and may not exceed 10 copy of a petition or any certification § 668.122 Determination of filing, receipt, pages, double-spaced, in length. A copy must be served upon the parties as and submission dates. of the response must be served on the provided in § 668.91(a)(4). The petition (a)(1) Appeals and written parties and the hearing official as or certification must reflect this service. submissions to a hearing official provided in § 668.122(a)(2). (d) If a party files a petition under this referred to in this subpart may be hand- * * * * * section, the hearing official may state to delivered, mailed, or filed electronically [FR Doc. 2013–19071 Filed 8–6–13; 8:45 am] the Secretary a view as to whether by use of the Office of Hearings and BILLING CODE 4000–01–P review is appropriate or inappropriate Appeals Electronic Filing System (OES). by submitting a brief statement (2)(i) Service on the other party of a addressing the party’s petition within 10 document required to be served on ENVIRONMENTAL PROTECTION days of the receipt of that petition by the another party may be made by mail or AGENCY hearing official. A copy of the statement by hand delivery, or, if agreed upon by must be served on all parties in the the parties, by use of the OES or by any 40 CFR Parts 9 and 721 manner provided in § 668.91(a)(4)(ii). other means agreed to by the parties. A [EPA–HQ–OPPT–2013–0399; FRL–9393–4] (e) A party’s response to a petition or party who agrees to receive a document certification for interlocutory review filed by another party by any means RIN 2070–AB27 must be filed within 7 days after service other than service by mail or hand- Significant New Use Rules on Certain of the petition or statement, as delivery may limit that agreement to one Chemical Substances applicable, and may not exceed 10 or more particular documents. pages, double-spaced, in length. The (ii) A party who agrees to service of AGENCY: Environmental Protection response must be filed, and a copy a document through the OES thereby Agency (EPA). served on the other party, as provided agrees that the notice of such filing ACTION: Direct final rule. in § 668.91(a)(4). provided to the party by the OES * * * * * suffices to meet any obligation of the SUMMARY: EPA is promulgating ■ 4. Section 668.113 is amended by filing party under these regulations to significant new use rules (SNURs) under revising paragraph (b) to read as follows: provide a copy of that document. the Toxic Substances Control Act * * * * * (TSCA) for 53 chemical substances § 668.113 Request for review. which were the subject of (c) Determination of filing, receipt, or * * * * * premanufacture notices (PMNs). Seven submission dates is based on the date of (b) The institution or servicer must of these chemical substances are subject hand-delivery, the date of receipt file its request for review no later than to TSCA section 5(e) consent orders recorded by the U.S. Postal Service, the 45 days from the date that the issued by EPA. This action requires date a document sent electronically by institution or servicer receives the final persons who intend to manufacture or using the OES is recorded as received as audit determination or final program process any of these 53 chemical indicated in the confirmation of receipt review determination. substances for an activity that is email for E-filing, or for other means, designated as a significant new use by * * * * * the date on which the delivery is ■ this rule to notify EPA at least 90 days 5. Section 668.116 is amended by recorded in the medium used for before commencing that activity. The revising paragraphs (e)(1)(ii), (iii), (v), delivery. and (vi) to read as follows: required notification will provide EPA * * * * * with the opportunity to evaluate the § 668.116 Hearing. ■ 7. Section 668.124 is amended by intended use and, if necessary, to * * * * * revising paragraphs (c), (d), and (e) to prohibit or limit that activity before it (e)(1) * * * read as follows: occurs.

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DATES: This rule is effective on October regulations.gov, your email address will I. General Information 7, 2013. For purposes of judicial review, be automatically captured and included A. Does this action apply to me? this rule shall be promulgated at 1 p.m. as part of the comment that is placed in (e.s.t.) on August 21, 2013. the docket and made available on the You may be potentially affected by Written adverse or critical comments, Internet. If you submit an electronic this action if you manufacture, process, or notice of intent to submit adverse or comment, EPA recommends that you or use the chemical substances critical comments, on one or more of include your name and other contact contained in this rule. The following list these SNURs must be received on or information in the body of your of North American Industrial before September 6, 2013 (see Unit VI. comment and with any disk or CD–ROM Classification System (NAICS) codes is of the SUPPLEMENTARY INFORMATION). If you submit. If EPA cannot read your not intended to be exhaustive, but rather EPA receives written adverse or critical comment due to technical difficulties provides a guide to help readers comments, or notice of intent to submit and cannot contact you for clarification, determine whether this document adverse or critical comments, on one or EPA may not be able to consider your applies to them. Potentially affected more of these SNURs before September comment. Electronic files should avoid entities may include: 6, 2013, EPA will withdraw the relevant the use of special characters, any form • Manufacturers or processors of one sections of this direct final rule before of encryption, and be free of any defects or more subject chemical substances its effective date. or viruses. (NAICS codes 325 and 324110), e.g., For additional information on related Docket: All documents in the docket chemical manufacturing and petroleum reporting requirement dates, see Units are listed in the docket index available refineries. This action may also affect I.A., VI., and VII. of the SUPPLEMENTARY at http://www.regulations.gov. Although certain entities through pre-existing INFORMATION. listed in the index, some information is import certification and export ADDRESSES: Submit your comments, not publicly available, e.g., CBI or other notification rules under TSCA. identified by docket identification (ID) information whose disclosure is Chemical importers are subject to the number EPA–HQ–OPPT–2013–0399, by restricted by statute. Certain other TSCA section 13 (15 U.S.C. 2612) one of the following methods: import certification requirements • material, such as copyrighted material, Federal eRulemaking Portal: http:// will be publicly available only in hard promulgated at 19 CFR 12.118 through www.regulations.gov. Follow the online copy. Publicly available docket 12.127 and 19 CFR 127.28. Chemical instructions for submitting comments. importers must certify that the shipment • materials are available electronically at Mail: Document Control Office http://www.regulations.gov, or, if only of the chemical substance complies with (7407M), Office of Pollution Prevention available in hard copy, at the OPPT all applicable rules and orders under and Toxics (OPPT), Environmental Docket. The OPPT Docket is located in TSCA. Importers of chemicals subject to Protection Agency, 1200 Pennsylvania the EPA Docket Center (EPA/DC) at Rm. these SNURs must certify their compliance with the SNUR Ave. NW., Washington, DC 20460–0001. 3334, EPA West Bldg., 1301 • requirements. The EPA policy in Hand Delivery: OPPT Document Constitution Ave. NW., Washington, support of import certification appears Control Office (DCO), EPA East Bldg., DC. The EPA/DC Public Reading Room at 40 CFR part 707, subpart B. In Rm. 6428, 1201 Constitution Ave. NW., hours of operation are 8:30 a.m. to 4:30 addition, any persons who export or Washington, DC. ATTN: Docket ID p.m., Monday through Friday, excluding intend to export a chemical substance Number EPA–HQ–OPPT–2013–0399. legal holidays. The telephone number of that is the subject of a proposed or final The DCO is open from 8 a.m. to 4 p.m., the EPA/DC Public Reading Room is SNUR, are subject to the export Monday through Friday, excluding legal (202) 566–1744, and the telephone notification provisions of TSCA section holidays. The telephone number for the number for the OPPT Docket is (202) 12(b) (15 U.S.C. 2611(b)) (see § 721.20), DCO is (202) 564–8930. Such deliveries 566–0280. Docket visitors are required and must comply with the export are only accepted during the DCO’s to show photographic identification, notification requirements in 40 CFR part normal hours of operation, and special pass through a metal detector, and sign 707, subpart D. arrangements should be made for the EPA visitor log. All visitor bags are deliveries of boxed information. processed through an X-ray machine B. What should I consider as I prepare Instructions: Direct your comments to and subject to search. Visitors will be my comments for EPA? docket ID number EPA–HQ–OPPT– provided an EPA/DC badge that must be 2013–0399. EPA’s policy is that all visible at all times in the building and 1. Submitting CBI. Do not submit this comments received will be included in returned upon departure. information to EPA through the docket without change and may be regulations.gov or email. Clearly mark made available at http:// FOR FURTHER INFORMATION CONTACT: For the part or all of the information that www.regulations.gov, including any technical information contact: Kenneth you claim to be CBI. For CBI personal information provided, unless Moss, Chemical Control Division information in a disk or CD–ROM that the comment includes information (7405M), Office of Pollution Prevention you mail to EPA, mark the outside of the claimed to be Confidential Business and Toxics, Environmental Protection disk or CD–ROM as CBI and then Information (CBI) or other information Agency, 1200 Pennsylvania Ave. NW., identify electronically within the disk or whose disclosure is restricted by statute. Washington, DC 20460–0001; telephone CD–ROM the specific information that Do not submit information that you number: (202) 564–9232; email address: is claimed as CBI. In addition to one consider to be CBI or otherwise [email protected]. complete version of the comment that protected through regulations.gov or For general information contact: The includes information claimed as CBI, a email. The regulations.gov Web site is TSCA-Hotline, ABVI-Goodwill, 422 copy of the comment that does not an ‘‘anonymous access’’ system, which South Clinton Ave., Rochester, NY contain the information claimed as CBI means EPA will not know your identity 14620; telephone number: (202) 554– must be submitted for inclusion in the or contact information unless you 1404; email address: TSCA- public docket. Information so marked provide it in the body of your comment. [email protected]. will not be disclosed except in If you send an email comment directly accordance with procedures set forth in to EPA without going through SUPPLEMENTARY INFORMATION: 40 CFR part 2.

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2. Tips for preparing your comments. Once EPA determines that a use of a information about the toxicity of the When submitting comments, remember chemical substance is a significant new chemical substances, likely human to: use, TSCA section 5(a)(1)(B) requires exposures and environmental releases i. Identify the document by docket ID persons to submit a significant new use associated with possible uses, and the number and other identifying notice (SNUN) to EPA at least 90 days four bulleted TSCA section 5(a)(2) information (subject heading, Federal before they manufacture or process the factors listed in this unit. Register date and page number). chemical substance for that use. Persons IV. Substances Subject to This Rule ii. Follow directions. The Agency may who must report are described in ask you to respond to specific questions § 14;721.5. EPA is establishing significant new or organize comments by referencing a use and recordkeeping requirements for C. Applicability of General Provisions Code of Federal Regulations (CFR) part 53 chemical substances in 40 CFR part or section number. General provisions for SNURs appear 721, subpart E. In this unit, EPA iii. Explain why you agree or disagree; in 40 CFR part 721, subpart A. These provides the following information for suggest alternatives and substitute provisions describe persons subject to each chemical substance: the rule, recordkeeping requirements, • PMN number. language for your requested changes. • iv. Describe any assumptions and exemptions to reporting requirements, Chemical name (generic name, if provide any technical information and/ and applicability of the rule to uses the specific name is claimed as CBI). • Chemical Abstracts Service (CAS) or data that you used. occurring before the effective date of the v. If you estimate potential costs or rule. Provisions relating to user fees Registry number (if assigned for non- burdens, explain how you arrived at appear at 40 CFR part 700. According to confidential chemical identities). • Basis for the TSCA section 5(e) your estimate in sufficient detail to § 14;721.1(c), persons subject to these consent order or, for TSCA non-section allow for it to be reproduced. SNURs must comply with the same 5(e) SNURs, the basis for the SNUR (i.e., vi. Provide specific examples to SNUN requirements and EPA regulatory SNURs without TSCA section 5(e) illustrate your concerns and suggest procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, consent orders). alternatives. • Tests recommended by EPA to these requirements include the vii. Explain your views as clearly as provide sufficient information to information submission requirements of possible, avoiding the use of profanity evaluate the chemical substance (see TSCA section 5(b) and 5(d)(1), the or personal threats. Unit VIII. for more information). exemptions authorized by TSCA section viii. Make sure to submit your • CFR citation assigned in the 5(h)(1), (h)(2), (h)(3), and (h)(5), and the comments by the comment period regulatory text section of this rule. deadline identified. regulations at 40 CFR part 720. Once This rule includes PMN substances, EPA receives a SNUN, EPA may take II. Background P–09–198 and P–09–199, whose regulatory action under TSCA section reported chemical names include the A. What action is the agency taking? 5(e), 5(f), 6, or 7 to control the activities term ‘‘carbon nanotube’’ or ‘‘CNT’’. for which it has received the SNUN. If EPA is promulgating these SNURs Because of a lack of established EPA does not take action, EPA is using direct final procedures. These nomenclature for carbon nanotubes, the required under TSCA section 5(g) to SNURs will require persons to notify TSCA Inventory names for carbon explain in the Federal Register its EPA at least 90 days before commencing nanotubes are currently in generic form, reasons for not taking action. the manufacture or processing of a e.g., carbon nanotube (CNT), multi- chemical substance for any activity III. Significant New Use Determination walled carbon nanotube (MWCNT), designated by these SNURs as a Section 5(a)(2) of TSCA states that double-walled carbon nanotube significant new use. Receipt of such EPA’s determination that a use of a (DWCNT), or single-walled carbon notices allows EPA to assess risks that chemical substance is a significant new nanotube (SWCNT). EPA uses the may be presented by the intended uses use must be made after consideration of specific structural characteristics and, if appropriate, to regulate the all relevant factors, including: provided by the PMN submitter to more proposed use before it occurs. • The projected volume of specifically characterize the Inventory Additional rationale and background to manufacturing and processing of a listing for an individual CNT. All these rules are more fully set out in the chemical substance. submitters of new chemical notices for preamble to EPA’s first direct final • The extent to which a use changes CNTs in this SNUR have claimed those SNUR published in the Federal Register the type or form of exposure of human specific structural characteristics as CBI. issue of April 24, 1990 (55 FR 17376). beings or the environment to a chemical EPA is publishing the generic chemical Consult that preamble for further substance. name along with the PMN number to information on the objectives, rationale, • The extent to which a use increases identify that a distinct chemical and procedures for SNURs and on the the magnitude and duration of exposure substance was the subject of the PMN basis for significant new use of human beings or the environment to without revealing the confidential designations, including provisions for a chemical substance. chemical identity of the PMN substance. developing test data. • The reasonably anticipated manner Confidentiality claims preclude a more and methods of manufacturing, detailed description of the identity of B. What is the agency’s authority for processing, distribution in commerce, these CNTs. If an intended manufacturer taking this action? and disposal of a chemical substance. or processor of CNTs is unsure of Section 5(a)(2) of TSCA (15 U.S.C. In addition to these factors whether its CNTs are subject to this 2604(a)(2)) authorizes EPA to determine enumerated in TSCA section 5(a)(2), the SNUR or any other SNUR, the company that a use of a chemical substance is a statute authorized EPA to consider any can either contact EPA or obtain a ‘‘significant new use.’’ EPA must make other relevant factors. written determination from EPA this determination by rule after To determine what would constitute a pursuant to the bona fide procedures at considering all relevant factors, significant new use for the 53 chemical § 721.11. EPA is using the specific including the four bulleted TSCA substances that are the subject of these structural characteristics, for all CNTs section 5(a)(2) factors listed in Unit III. SNURs, EPA considered relevant submitted as new chemical substances

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under TSCA, to help develop standard consent orders under TSCA section 5(e). 4. No use of the substances resulting nomenclature for placing these chemical In these cases, for a variety of reasons, in surface water releases during substances on the TSCA Inventory. EPA EPA did not find that the use scenario processing and use. has compiled a generic list of those described in the PMN triggered the Recommended testing: EPA has structural characteristics entitled determinations set forth under TSCA determined that the following tests ‘‘Material Characterization of Carbon section 5(e). However, EPA does believe would help characterize possible effects Nanotubes for Molecular Identity (MI) that certain changes from the use of the PMN substances. The PMN Determination & Nomenclature.’’ A scenario described in the PMN could submitter has agreed not to exceed a copy of this list is available in the result in increased exposures, thereby specified production/time limit without docket for these SNURs under docket ID constituting a ‘‘significant new use.’’ performing a 90-day inhalation toxicity number EPA–HQ–OPPT–2013–0399. If These so-called ‘‘non-section 5(e) test (OPPTS Test Guideline 870.3465) in EPA develops a more specific generic SNURs’’ are promulgated pursuant to rats with a post exposure observation chemical name for these materials, that § 721.170. EPA has determined that period of up to 3 months, name will be made publicly available. every activity designated as a bronchoalveolar lavage fluid (BALF) The regulatory text section of this rule ‘‘significant new use’’ in all non-section analysis, a determination of specifies the activities designated as 5(e) SNURs issued under § 721.170 cardiovascular toxicity (clinically-based significant new uses. Certain new uses, satisfies the two requirements stipulated blood/plasma protein analyses), including production volume limits in § 721.170(c)(2), i.e., these significant histopathology of the heart, and certain (i.e., limits on manufacture volume) and new use activities, ‘‘(i) are different from physical/chemical data. other uses designated in this rule may those described in the premanufacture CFR citation: 40 CFR 721.10671. be claimed as CBI. Unit IX. discusses a notice for the substance, including any PMN Numbers P–09–447 and P–09–448 procedure companies may use to amendments, deletions, and additions ascertain whether a proposed use of activities to the premanufacture Chemical name: Sodium olefin constitutes a significant new use. notice, and (ii) may be accompanied by sulfonate derivative (generic). This rule includes 7 PMN substances changes in exposure or release levels CAS number: Not available. Effective date of TSCA section 5(e) (P–09–198, P–09–199, P–09–447, P–09– that are significant in relation to the consent order: February 15, 2013. 448, P–12–539, P–13–107, and P–13– health or environmental concerns Basis for TSCA section 5(e) consent 109) that are subject to ‘‘risk-based’’ identified’’ for the PMN substance. consent orders under TSCA section order: The PMNs state that the generic 5(e)(1)(A)(ii)(I) where EPA determined PMN Numbers P–09–198 and P–09–199 (non-confidential) use of the substances will be enhanced oil recovery that activities associated with the PMN Chemical names: Multi-walled carbon applications. Based on a CBI analog, substances may present unreasonable nanotubes (generic). risk to human health or the EPA predicts toxicity to aquatic CAS numbers: Not available. environment. Those consent orders organisms may occur at concentrations Effective date of TSCA section 5(e) require protective measures to limit that exceed 10 parts per billion (ppb) of consent order: June 4, 2010. exposures or otherwise mitigate the the aggregate of these PMN substances potential unreasonable risk. The so- Basis for TSCA section 5(e) consent in surface waters. The consent order called ‘‘5(e) SNURs’’ on these PMN order: The consolidated PMN states that was issued under TSCA sections substances are promulgated pursuant to the generic (non-confidential) use of the 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based § 721.160 and are based on and substances will be as additives for on a finding that uncontrolled consistent with the provisions in the reinforcement. Based on test data on manufacture, processing, distribution in underlying consent orders. The 5(e) analogous respirable, poorly soluble commerce, use, and disposal of these SNURs designate as a ‘‘significant new particulates and other CNTs, EPA substances may present an unreasonable use’’ the absence of the protective identified concerns for pulmonary risk of injury to the environment. To measures required in the corresponding toxicity, fibrosis, carcinogenicity, protect against these risks, the consent consent orders. mutagenicity, and immunotoxicity. order requires: In addition, this rule includes SNURs Further, available data suggests that 1. Establishment and use of a hazard on 3 PMN substances (P–12–539, P–13– pulmonary deposition of some communication program. 107, and P–13–109) that are subject to nanoparticles, including CNT may 2. Use of the substances only as ‘‘exposure-based’’ consent orders under induce cardiovascular toxicity if described in the consent order. TSCA section 5(e)(1)(A)(ii)(II), wherein inhaled. The order was issued under 3. No use of the substances resulting EPA determined that the PMN section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of in surface water concentrations substances are expected to be produced TSCA based on a finding that these exceeding 10 ppb of the aggregate of in substantial quantities, and that there substances may present an unreasonable these PMN substances. may either be significant or substantial risk of injury to human health. To Recommended testing: EPA has human exposure and/or the PMN protect against this risk, the consent determined that a daphnid chronic substance may enter the environment in order requires: toxicity test (OPPTS Test Guidelines substantial quantities. The TSCA 1. Use of personal protective 850.1300) and a fish early life stage section 5(e) consent orders require equipment including gloves and toxicity test (OPPTS Test Guidelines submission of certain test data to EPA protective clothing impervious to the 850.1400) on either P–09–447 or P–09– before the manufacturer may exceed a substances when there is potential 448, would help characterize the specified production volume. These dermal exposure and a National environmental effects of the PMN SNURs designate as a ‘‘significant new Institute of Occupational Safety and substances. The order does not require use’’ the absence of the protective Health (NIOSH)-certified full-face the submission of these tests at any measures or exceedance of the respirator with N–100 cartridges when specified time or production volume. production volume limit required in the there is potential inhalation exposure. However, the order’s restrictions on TSCA section 5(e) consent orders. 2. No domestic manufacture. manufacture, processing, distribution in This rule also includes SNURs on 46 3. Use of the substances only as commerce, use, and disposal of the PMN substances that are not subject to described in the consent order. PMN substances will remain in effect

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until the order is modified or revoked than 1% of that PMN substance by information, the PMN substance meets by EPA based on submission of that or weight. the concern criteria at § 721.170 (b)(4)(i) other relevant information. Recommended testing: EPA has and (b)(4)(ii). CFR citation: 40 CFR 721.10672. determined that analysis for chain Recommended testing: EPA has length and percent chlorination (for determined that the results of a daphnid PMN Numbers P–12–539, P–13–107, and example by gas chromatography-mass chronic toxicity test (OPPTS Test P–13–109 spectrometry or high performance liquid Guideline 850.1300), a fish early-life Chemical names: Alkanes, C21–34— chromatography-mass spectrometry stage toxicity test (OPPTS Test branched and linear, chloro (P–12–539), (GC/MS HPLC/MS)); a modified semi- Guideline 850.1400), and an inherent Alkanes, C22–30—branched and linear, continuous activated sludge (SCAS) test biodegradability—Concawe test (OPPTS chloro (P–13–107); and Alkanes, C24– (OPPTS Test Guideline 835.3210), Test Guidelines 835.3215) would help 28, chloro (P–13–109). modified SCAS test for insoluble and characterize the environmental effects of CAS numbers: 1417900–96–9 (P–12– volatile chemicals (OPPTS Test the PMN substance. EPA also 539), 1401947–24–0 (P–13–107), and Guideline 835.5045), or Zahn Wellens/ recommends that the guidance 1402738–52–6 (P–13–109). EMPA test (OPPTS Test Guideline document on aquatic toxicity testing of Effective date of TSCA section 5(e) 835.3200); aerobic and anaerobic soil difficult substances and mixtures (OECD consent order: March 19, 2013. metabolism studies (Organisation for Test Guideline 23) be followed to Basis for TSCA section 5(e) consent Economic Co-operation and facilitate solubility in the test media, order: The PMNs state that the uses of Development (OECD) Test Guideline because of the PMN’s low water the substances are as flame retardants/ 307); a bioaccumulation in sediment- solubility. plasticizers in polymers and extreme dwelling benthic oligochaetes test CFR citation: 40 CFR 721.10676. pressure lubricants in metal working (OECD Test Guideline 315) on the PMN PMN Number P–12–584 fluids (MWFs). There are also several substances and their potential CBI uses that are generically described degradation products; and a sediment- Chemical name: Alkyl phosphonate as: Plasticizer and lubricant with flame water chironomid life-cycle toxicity test (generic). retardant properties. By analogy to using spiked water or spiked sediment CAS number: Not available. medium chain chlorinated paraffins test (OECD Test Guideline 233) or a Basis for action: The PMN states that (MCCPs—alkyl chain length of 14 to 17), sediment-water lumbriculus toxicity test the generic (non-confidential) use of the EPA expects very long chain chlorinated using spiked sediment (OECD Test substance is as an intermediate. Based paraffins (vLCCPs) and possible Guideline 225) on the PMN substances on test data on an analog substance, degradation products to be potentially and their presumed degradation EPA identified concerns for eye, lung, highly persistent, potentially products would help characterize the and mucous membrane irritation as well bioaccumulative, and potentially toxic. effects of the PMN substances. Testing as kidney and developmental toxicity to Transport and magnification across specifications are stated in the section workers exposed to the PMN substance. trophic levels may also result in toxicity 5(e) consent order for P–12–539, P–13– For the use described in the PMN, to higher organisms, including fish, 107, and P–13–109 available in the significant worker exposure is unlikely. higher predators, and potentially docket under docket ID number EPA– Further, based on EcoSAR analysis of humans. EPA has concerns about the HQ–OPPT–2013–0399. test data on analogous phosphinate potential for the vLCCPs to degrade to CFR citations: 40 CFR 721.10673 (P– esters, EPA predicts toxicity to aquatic shorter chain chlorinated compounds, 12–539); 40 CFR 721.10674 (P–13–107); organisms may occur at concentrations as well as concerns about potential and 40 CFR 721.10675 (P–13–109). that exceed 1 ppb of the PMN substance impurities or small fractions of MCCPs in surface waters. As described in the and/or long-chain chlorinated paraffins PMN Number P–12–551 PMN, releases of the PMN substance are (LCCPs—alkyl chain length of 18 to 20). Chemical name: Aromatic not expected to result in surface water The consent order was issued under hydrocarbon mixture (generic). concentrations that exceed 1 ppb. TSCA sections 5(e)(1)(A)(i), CAS number: Not available. Therefore, EPA has not determined that 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) Basis for action: The PMN states that the proposed manufacturing, based on a finding that these substances the generic (non-confidential) use of the processing, or use of the substance may may present an unreasonable risk of substance is as feedstock for present an unreasonable risk. EPA has injury to the environment and the fractionation process. Based on test data determined, however, that any use of substances may be produced in on the PMN substance and ecological the substance other than as an substantial quantities and may structural activity relationship (EcoSAR) intermediate, any use of the substance reasonably be anticipated to enter the analysis on analogous neutral organics, without the use of impervious gloves environment in substantial quantities, EPA predicts toxicity to aquatic when there is potential dermal and there may be significant (or organisms may occur at concentrations exposure, or any use of the substance substantial) human exposures to the that exceed 78 ppb of the PMN resulting in surface water PMN substances. To protect against substance in surface waters. As concentrations exceeding 1 ppb may these risks, the consent order requires: described in the PMN, releases of the cause serious health effects and 1. Manufacture or import of the substance are not expected to result in significant adverse environmental substances at a cumulative, aggregate surface water concentrations that exceed effects. Based on this information, the volume not to exceed 1,200,000 78 ppb. Therefore, EPA has not PMN substance meets the concern kilograms (kg), 14,100,000 kg, determined that the proposed criteria at § 721.170 (b)(3)(ii) and 59,100,000 kg, 78,400,000 kg, and manufacturing, processing, or use of the (b)(4)(ii). 86,100,000 kg unless the company has substance may present an unreasonable Recommended testing: EPA has submitted the results of certain risk. EPA has determined, however, that determined that the results of a environmental effects studies. any use of the substance resulting in combined repeated dose toxicity with 2. No manufacture of the substances surface water concentrations exceeding the reproduction/development toxicity with the amount of chlorinated paraffins 78 ppb may cause significant adverse screening test (OPPTS Test Guideline with an alkyl chain ≤ 20 to exceed more environmental effects. Based on this 870.3650); an algal toxicity test (OCSPP

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Test Guideline 850.4500); an aquatic consumer exposures. Therefore, EPA 850.1075); an aquatic invertebrate acute invertebrate acute toxicity test, has not determined that the proposed toxicity test, freshwater daphnids freshwater daphnids (OPPTS Test manufacturing, processing, or use of the (OPPTS Test Guideline 850.1010); and Guideline 850.1010); and a fish acute substance may present an unreasonable an algal toxicity test (OCSPP Test toxicity test, freshwater and marine risk. EPA has determined, however, that Guideline 850.4500) would help (OPPTS Test Guideline 850.1075) would use of the substance in consumer characterize the environmental effects of help characterize the human health and products or any use of the substance the PMN substances. EPA also environmental effects of the PMN without the use of impervious gloves, recommends that the guidance substance. when there is potential dermal document on aquatic toxicity testing of CFR citation: 40 CFR 721.10677. exposure, may result in significant difficult substances and mixtures (OECD adverse human health effects. Based on PMN Number P–13–10 Test Guideline 23) be followed. Testing this information, the PMN substance may be performed on any one of the Chemical name: 1,4- meets the concern criteria at PMN substances (P–13–44, P–13–46, P– Cyclohexanedicarboxylic acid, 1,4- § 721.170(b)(3)(i). 13–47, P–13–50, or P–13–51). dimethyl ester, hydrogenolysis Recommended testing: EPA has CFR citation: 40 CFR 721.10680. products. determined that the results of a skin CAS number: 1373220–73–5. absorption: In vivo method test (OECD PMN Numbers P–13–55 and P–13–56 Basis for action: The PMN states that Test Guideline 427) would help Chemical names: Alkaneamide, halo- the generic (non-confidential) use of the characterize the human health effects of dialkylthienyl-alkoxydialkyl-, manuf. of substance is as a chemical intermediate. the PMN substance. by-products from (generic). Based on EcoSAR analysis of test data CFR citation: 40 CFR 721.10679. CAS numbers: Not available. on analogous esters, EPA predicts Basis for action: The PMNs states that PMN Numbers P–13–44, P–13–46, P–13– toxicity to aquatic organisms may occur the generic (non-confidential) use of the 47, P–13–50, and P–13–51 at concentrations that exceed 20 ppb of substances will be as starting material in the PMN substance in surface waters. As Chemical names: Fatty acid amides sulfuric acid production. Based on described in the PMN, releases of the (generic). EcoSAR analysis of test data on PMN substance are not expected to CAS numbers: Not available. analogous haloacetamides, EPA predicts result in surface water concentrations Basis for action: The PMNs state that toxicity to aquatic organisms may occur that exceed 20 ppb. Therefore, EPA has the use of the substances will be as at concentrations that exceed 1 ppb of not determined that the proposed adhesive promoters for asphalt the PMN substances in surface waters. manufacturing, processing, or use of the applications and emulsifiers for asphalt As described in the PMN, releases of the substance may present an unreasonable applications. Based on the EcoSAR PMN substances are not expected to risk. EPA has determined, however, that analysis of test data on analogous result in surface water concentrations any use of the substance resulting in aliphatic amines and amides, EPA exceeding 1 ppb. Therefore, EPA has not surface water concentrations exceeding predicts toxicity to aquatic organisms determined that the proposed 20 ppb may cause significant adverse may occur at concentrations that exceed manufacturing, processing, or use of environmental effects. Based on this 1 ppb of the PMN substances these substances may present an information, the PMN substance meets respectively in surface waters for greater unreasonable risk. EPA has determined, the concern criteria at than 20 days per year. This 20-day however, that any use of these § 721.170(b)(4)(ii). criterion is derived from partial life substances other than as stated in the Recommended testing: EPA has cycle tests (daphnid chronic and fish PMN or use of the substances resulting determined that results of an aquatic early-life stage tests) that typically range in releases to surface water invertebrate acute toxicity test, from 21 to 28 days in duration. EPA concentrations exceeding 1 ppb may freshwater daphnids (OPPTS Test predicts toxicity to aquatic organisms cause significant adverse environmental Guideline 850.1010); a fish acute may occur if releases of the PMN effects. Based on this information, the toxicity test, freshwater and marine substances to surface waters exceed PMN substances meets the concern (OPPTS Test Guideline 850.1075); and releases from the uses described in the criteria at § 721.170(b)(4)(ii). an algal toxicity test (OCSPP Test PMNs. For the use described in the Recommended testing: EPA has Guideline 850.4500) would help PMNs, environmental releases did not determined that the results of an algal characterize the environmental effects of exceed the respective concentrations of toxicity test (OCSPP Test Guideline the PMN substance. concern for more than 20 days per year. 850.4500); an aquatic invertebrate acute CFR citation: 40 CFR 721.10678. Therefore, EPA has not determined that toxicity test, freshwater daphnids the proposed manufacturing, PMN Number P–13–30 (OPPTS Test Guideline 850.1010); and a processing, or use of the substance may fish acute toxicity test, freshwater and Chemical name: Carboxylic acid, present an unreasonable risk. EPA has marine (OPPTS Test Guideline substituted alkylstannylene ester, determined, however, that any use of 850.1075) would help characterize the reaction products with inorganic acid the substances other than as an adhesive environmental effects of the PMN tetra alkyl ester (generic). promoter for asphalt applications or as substances. CAS number: Not available. emulsifiers for asphalt applications, as CFR citation: 40 CFR 721.10681. Basis for action: The PMN states that described in the PMNs, could result in the generic (non-confidential) use of the exposures which may cause significant PMN Numbers P–13–63, P–13–64, P–13– substance is as an adhesive/sealant adverse environmental effects. Based on 65, P–13–69, P–13–70, P–13–71, P–13– component. Based on test data on the this information, the PMN substances 72, P–13–73, P–13–74, P–13–75, P–13– PMN substance, EPA identified meet the concern criteria at 76, and P–13–77 concerns for thymus toxicity to workers § 721.170(b)(4)(ii). Chemical names: Fatty acid amide exposed to the PMN substance. As Recommended testing: EPA has hydrochlorides (generic). described in the PMN, adequate dermal determined that the results of a fish CAS numbers: Not available. protection is used and worker exposure acute toxicity test, freshwater and Basis for action: The PMNs state that will be minimal and there are no marine (OPPTS Test Guideline the substances will be used as

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surfactants for asphalt emulsions. Based may occur at concentrations that exceed function of pH test (OPPTS Test on the EcoSAR analysis of test data on 1 ppb of the PMN substance in surface Guideline 835.2120) would help analogous aliphatic amines and amides, waters. As described in the PMN, characterize the environmental effects of EPA predicts toxicity to aquatic releases of the PMN substance are not the PMN substance. organisms may occur at concentrations expected to result in surface water CFR citation: 40 CFR 721.10684. that exceed 1 ppb (for P–13–63 P–13– concentrations that exceed 1 ppb. PMN Number P–13–170 64, P–13–65, P–13–69, P–13–70, P–13– Therefore, EPA has not determined that 71 P–13–72, P–13–73, and P–13–74) and the proposed manufacturing, Chemical name: Phosphoric acid, 2 ppb (for P–13–75, P–13–76, and P–13– processing, or use of the substance may mixed esters (generic). 77) of the PMN substances respectively present an unreasonable risk. EPA has CAS number: Not available. in surface waters for greater than 20 determined, however, that any use of Basis for action: The PMN states that days per year. This 20-day criterion is the substance resulting in surface water the generic (non-confidential) use of the derived from partial life cycle tests concentrations exceeding 1 ppb may substance is as a plastic additive. Based (daphnid chronic and fish early-life cause significant adverse environmental on test data on the PMN substance, EPA stage tests) that typically range from 21 effects. Based on this information, the predicts toxicity to aquatic organisms to 28 days in duration. EPA predicts PMN substance meets the concern may occur at concentrations that exceed toxicity to aquatic organisms may occur criteria at § 721.170(b)(4)(ii). 1 ppb of the PMN substance in surface if releases of the PMN substances to Recommended testing: EPA has waters. As described in the PMN, surface water exceed releases from the determined that the results of a ready releases of the PMN substance are not use described in the PMNs. For the use biodegradability test (OECD Test expected to result in surface water described in the PMNs, environmental Guideline 301B), a daphnid chronic concentrations that exceed 1 ppb. releases did not exceed the respective toxicity test (OPPTS Test Guideline Therefore, EPA has not determined that concentrations of concern for more than 850.1300), a fish early-life stage toxicity the proposed manufacturing, 20 days per year. Therefore, EPA has not test (OPPTS Test Guideline 850.1400), processing, or use of the substance may determined that the proposed and an algal toxicity test (OCSPP Test present an unreasonable risk. EPA has manufacturing, processing, or use of the Guideline 850.4500) would help determined, however, that any use of substance may present an unreasonable characterize the environmental effects of the substance resulting in surface water risk. EPA has determined, however, that the PMN substance. concentrations exceeding 1 ppb may use of the substances other than as CFR citation: 40 CFR 721.10683. cause significant adverse environmental effects. Based on this information, the surfactants for use in asphalt emulsions, PMN Number P–13–135 as described in the PMNs, could result PMN substance meets the concern in exposures which may cause Chemical name: Substituted criteria at § 721.170(b)(4)(i). significant adverse environmental benzenamine schiff base (generic). Recommended testing: EPA has effects. Based on this information, the CAS number: Not available. determined that the results of a daphnid PMN substances meet the concern Basis for action: The PMN states that chronic toxicity test (OPPTS Test criteria at § 721.170(b)(4)(ii). the use of the substance is as an Guideline 850.1300) and a fish early-life Recommended testing: EPA has intermediate monomer for use in the stage toxicity test (OPPTS Test determined that the results of a fish manufacture of another monomer. Based Guideline 850.1400) would help acute toxicity test, freshwater and on the EcoSAR analysis of test data on characterize the environmental effects of marine (OPPTS Test Guideline analogous schiff bases, EPA predicts the PMN substance. EPA also 850.1075); an aquatic invertebrate acute toxicity to aquatic organisms may occur recommends that the guidance toxicity test, freshwater daphnids at concentrations that exceed 1 ppb of document on aquatic toxicity testing of (OPPTS Test Guideline 850.1010); and the PMN substance in surface waters. As difficult substances and mixtures (OECD an algal toxicity test (OCSPP Test described in the PMN, releases of the Test Guideline 23) be followed. Guideline 850.4500) would help PMN substance to surface waters are not CFR citation: 40 CFR 721.10685. expected. Therefore, EPA has not characterize the environmental effects of PMN Numbers P–13–180, P–13–181, P– the PMN substances. EPA also determined that the proposed manufacturing, processing, or use of the 13–182, P–13–183, P–13–184, and P–13– recommends that the guidance 185 document on aquatic toxicity testing of substance may present an unreasonable difficult substances and mixtures (OECD risk. EPA has determined, however, that Chemical names: Fatty acid amides Test Guideline 23) be followed. Testing any use of the substance resulting in (generic). may be performed on any one of the surface water concentrations exceeding CAS numbers: Not available. Basis for action: The PMNs state that PMN substances (P–13–63, P–13–64, P– 1 ppb may cause significant adverse the use of the substances is as adhesive 13–65, P–13–69, P–13–70, P–13–71, P– environmental effects. Based on this promoters for asphalt applications and 13–72, P–13–73, P–13–74, P–13–75, P– information, the PMN substance meets emulsifiers for asphalt applications. 13–76, or P–13–77). the concern criteria at CFR citation: 40 CFR 721.10682. § 721.170(b)(4)(ii). Based on the EcoSAR analysis of test Recommended testing: EPA has data on analogous aliphatic amines and PMN Number P–13–131 determined that the results of an algal amides, EPA predicts toxicity to aquatic Chemical name: Dialkylamino toxicity test (OCSPP Test Guideline organisms may occur at concentrations cocoalkyl alkylamide acid salt (generic). 850.4500); a daphnid chronic toxicity that exceed 1 ppb (for P–13–180, P–13– CAS number: Not available. test (OPPTS Test Guideline 850.1300); a 182, and P–13–185); 2 ppb (for P–13– Basis for action: The PMN states that fish early-stage toxicity test (OPPTS Test 181 and P–13–183); and 4 ppb (for P– the generic (non-confidential) use of the Guideline 850.1400); a partition 13–184) of the PMN substances in substance is as an inhibitor for oil field coefficient (n-octanol/water), estimation surface waters for greater than 20 days applications. Based on the EcoSAR by liquid chromatography test (OPPTS per year. This 20-day criterion is analysis of test data on analogous Test Guideline 830.7570); a ready derived from partial life cycle tests amides and aliphatic amines, EPA biodegradability test (OECD Test (daphnid chronic and fish early-life predicts toxicity to aquatic organisms Guideline 301); and a hydrolysis as a stage tests) that typically range from 21

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to 28 days in duration. EPA predicts from 21 to 28 days in duration. EPA substance are not expected to result in toxicity to aquatic organisms may occur predicts toxicity to aquatic organisms surface water concentrations that exceed if releases of the PMN substances to may occur if releases of the PMN 6 ppb. Therefore, EPA has not surface water exceed releases from the substances to surface waters exceed determined that the proposed use described in the PMNs. For the use releases from the use described in the manufacturing, processing, or use of the described in the PMNs, environmental PMNs. For the use described in the substance may present an unreasonable releases did not exceed the respective PMNs, environmental releases did not risk. EPA has determined, however, that concentrations of concern for more than exceed the respective surface water use of the substance other than as 20 days per year. Therefore, EPA has not concentrations for more than 20 days described in the PMN or any use of the determined that the proposed per year. Therefore, EPA has not substance resulting in surface water manufacturing, processing, or use of the determined that the proposed concentrations exceeding 6 ppb may substance may present an unreasonable manufacturing, processing, or use of the cause serious health or significant risk. EPA has determined, however, that substances may present an unreasonable adverse environmental effects. Based on use of the substances other than as risk. EPA has determined, however, that this information, the PMN substance adhesive promoters for asphalt any use of the substances other than as meets the concern criteria at § 721.170 applications or emulsifiers for asphalt surfactants for asphalt emulsions could (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). applications, as described in the PMNs, result in exposures which may cause Recommended testing: EPA has could result in exposures which may significant adverse environmental determined that a carcinogenicity test cause significant adverse environmental effects. Based on this information, the (OPPTS Test Guideline 870.4200) in effects. Based on this information, the PMN substances meet the concern rats; an aquatic invertebrate acute PMN substances meet the concern criteria at § 721.170(b)(4)(ii). toxicity test, freshwater daphnids criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has (OPPTS Test Guideline 850.1010); a fish Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); and an algal toxicity test marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute (OCSPP Test Guideline 850.4500) would 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids help characterize the human health and toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and environmental effects of the PMN (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test substance. EPA recommends that the an algal toxicity test (OCSPP Test Guideline 850.4500) would help guidance document on aquatic toxicity Guideline 850.4500) would help characterize the environmental effects of testing of difficult substances and characterize the environmental effects of the PMN substances. EPA also mixtures (OECD Test Guideline 23) be the PMN substances. EPA also recommends that the guidance followed. recommends that the guidance document on aquatic toxicity testing of CFR citation: 40 CFR 721.10688. document on aquatic toxicity testing of difficult substances and mixtures (OECD PMN Number P–13–225 difficult substances and mixtures (OECD Test Guideline 23) be followed. Testing Test Guideline 23) be followed. Testing may be performed on any one of the Chemical name: Organo zinc salts may be performed on any one of the PMN substances (P–13–201, P–13–203, (generic). PMN substances (P–13–180, P–13–181, P–13–204, P–13–205, P–13–206, P–13– CAS number: Not available. P–13–182, P–13–183, P–13–184, or P– 207, P–13–208, or P–13–209). Basis for action: The PMN states that 13–185), however, it is recommended CFR citation: 40 CFR 721.10687. the generic (non-confidential) use of the substance is as a stabilizer for that it be conducted on P–13–182 as PMN Number P–13–221 EPA predicts this substance to be most thermoplastics. Based on the EcoSAR acutely toxic to aquatic organisms. Chemical name: Copper, chloro[tris(2- analysis of test data on analogous CFR citation: 40 CFR 721.10686. chloroethyl) phosphite-.kappa.P]-. organic zinc compounds, EPA predicts CAS number: 24484–01–3. toxicity to aquatic organisms may occur PMN Numbers P–13–201, P–13–203, P– Basis for action: The PMN states that at concentrations that exceed 3 ppb of 13–204, P–13–205, P–13–206, P–13–207, the generic (non-confidential) use of the the PMN substance in surface waters. As P–13–208, and P–13–209 substance will be as a manufacturing described in the PMN, releases of the Chemical names: Fatty acid amide process aid. Also, EPA identified substance are not expected to result in hydrochlorides (generic). concerns for oncogenicity, mutagenicity, surface water concentrations that exceed CAS numbers: Not available. and developmental toxicity based on the 3 ppb. Therefore, EPA has not Basis for action: The PMNs state that alkylation potential of the PMN determined that the proposed the use of the substances is as substance and concern for neurotoxicity manufacturing, processing, or use of the surfactants for asphalt emulsions. Based and reproductive toxicity based on substance may present an unreasonable on the EcoSAR analysis of test data on analog test data. There is also concern risk. EPA has determined, however, that analogous aliphatic amines, EPA for immunotoxicity based on the any use of the substance resulting in predicts toxicity to aquatic organisms presence of the copper ion. These surface water concentrations exceeding may occur at concentrations that exceed concerns are for effects to workers from 3 ppb may cause significant adverse 1 ppb (for P–13–204, P–13–206, and P– inhalation exposure to the PMN. environmental effects. Based on this 13–207); 2 ppb (for P–13–205); 3 ppb Additionally, based on the EcoSAR information, the PMN substance meets (for P–13–209); 5 ppb (for P–13–201); 6 analysis of test data on analogous the concern criteria at ppb (for P–13–208); and 12 ppb (for P– organic copper compounds, EPA § 721.170(b)(4)(ii). 13–203) of the PMN substances predicts toxicity to aquatic organisms Recommended testing: EPA has respectively in surface waters for greater may occur at concentrations that exceed determined that the results of a daphnid than 20 days per year. This 20-day 6 ppb of the PMN substance in surface chronic toxicity test (OPPTS Test criterion is derived from partial life waters. As described in the PMN, Guideline 850.1300), a fish early-life cycle tests (daphnid chronic and fish significant workplace exposures are not stage toxicity test (OPPTS Test early-life stage tests) that typically range expected and releases of the PMN Guideline 850.1400), and an algal

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toxicity test (OCSPP Test Guideline manufacturing, processing, or use of the PMN Number P–13–338 850.4500) would help characterize the substance may present an unreasonable Chemical name: Diphenylmethane environmental effects of the PMN risk. EPA has determined, however, that diisocyanate polymer with alkanoic substance. any use of the substance resulting in diacid and alkanediol (generic). CFR citation: 40 CFR 721.10689. surface water concentrations exceeding CAS number: Not available. PMN Number P–13–232 1 ppb may cause significant adverse Basis for action: The PMN states that environmental effects. Based on this the generic (non-confidential) use of the Chemical name: Benzenedicarboxylic information, the PMN substance meets substance will be as a polymer acid, polymer with substituted the concern criteria at intermediate for adhesive manufacture. alkanediol, dodecanedioic acid, 1,2- § 721.170(b)(4)(ii). Based on analogous diisocyanates, EPA ethanediol, alkanedioic acid, identified concerns for dermal and alkanediol,.alpha.-hydro-.omega.- Recommended testing: EPA has determined that an algal toxicity test respiratory sensitization, irritation, and hydroxypoly[oxyalkanediyl], 1,3- lung effects. For the use described in the isobenzofurandione, methylene (OCSPP Test Guideline 850.4500), a daphnid chronic toxicity test (OPPTS PMN, EPA does not expect significant diphenyl diisocyanate, 2-oxepanone, occupational or consumer inhalation 2,2’-oxybis[ethanol] and polymethylene Test Guideline 850.1300); a fish early- life stage toxicity test (OPPTS Test exposure as the substance is not applied polyphenylene isocyanate (generic). using a method that generates a vapor, CAS number: Not available. Guideline 850.1400) and the shake flask mist, or aerosol or used in a consumer Basis for action: The PMN states that die-away test (OPPTS Test Guideline product. Therefore, EPA has not the generic (non-confidential) use of the 835.3170) would help characterize the determined that the proposed substance will be as an industrial environmental effects of the PMN manufacturing, processing, or use of the adhesive. Based on analogous substance. EPA recommends that the substance may present an unreasonable diisocyanates, EPA identified concerns guidance document on aquatic toxicity risk. EPA has determined, however, that for sensitization as well as lung and testing of difficult substances and any use of the substance in consumer mucous membrane irritation. For the mixtures (OECD Test Guideline 23) be products or any use of the substance use described in the PMN, EPA does not followed. involving an application method that expect significant occupational or CFR citation: 40 CFR 721.10691. generates a vapor, mist, or aerosol may consumer inhalation exposure as the cause serious health effects. Based on substance is not applied using a method PMN Number P–13–288 this information, the PMN substance that generates a vapor, mist, or aerosol Chemical name: Fluorinated alkyl meets the concern criteria at or used in a consumer product. dianiline (generic). § 721.170(b)(3)(ii). Therefore, EPA has not determined that CAS number: Not available. Recommended testing: EPA has the proposed manufacturing, determined that the results of a skin Basis for action: The PMN states that processing, or use of the substance may sensitization test (OPPTS Test Guideline the generic (non-confidential) use of the present an unreasonable risk. EPA has 870.2600) and a 90-day inhalation substance is as a polymer precursor. determined, however, that any use of toxicity test (OPPTS Test Guideline EPA identified concern for acute the substance in consumer products or 870.3465) would help characterize the toxicity based on test data on the PMN any use of the substance involving an human health effects of the PMN substance. Also, EPA identified concern application method that generates a substance. vapor, mist, or aerosol may cause for dermal sensitization and CFR citation: 40 CFR 721.10693. serious health effects. Based on this oncogenicity based on benzidines; information, the PMN substance meets concern for neurotoxicity based on V. Rationale and Objectives of the Rule the concern criteria at aromatic amines; and concern for A. Rationale § 721.170(b)(3)(ii). retinopathy based on dianiline Recommended testing: EPA has compounds. The concern is for workers During review of the PMNs submitted determined that the results of a skin exposed to the PMN substance. For the for the chemical substances that are sensitization test (OPPTS Test Guideline industrial use described in the PMN, subject to these SNURs, EPA concluded 870.2600) and a 90-day inhalation significant worker dermal or inhalation that for 7 of the 53 chemical substances, toxicity test (OPPTS Test Guideline exposure is not expected. Therefore, regulation was warranted under TSCA 870.3465) would help characterize the EPA has not determined that the section 5(e), pending the development human health effects of the PMN proposed manufacturing, processing, or of information sufficient to make substance. use of the substance may present an reasoned evaluations of the health or CFR citation: 40 CFR 721.10690. unreasonable risk. EPA has determined, environmental effects of the chemical substances. The basis for such findings PMN Number P–13–267 however, that use of the PMN substance other than as an intermediate may result is outlined in Unit IV. Based on these Chemical name: Fatty acid amide in serious health effects. Based on this findings, TSCA section 5(e) consent (generic). information, the PMN substance meets orders requiring the use of appropriate CAS number: Not available. the concern criteria at § 721.170 exposure controls were negotiated with Basis for action: The PMN states that (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii). the PMN submitters. The SNUR the use of the substance is as a polymer provisions for these chemical additive. Based on the EcoSAR analysis Recommended testing: EPA has substances are consistent with the of test data on analogous amides, EPA determined that the results of a rat acute provisions of the TSCA section 5(e) predicts toxicity to aquatic organisms oral retinopathy screening study consent orders. These SNURs are may occur at concentrations that exceed (protocol to be approved by EPA to promulgated pursuant to § 14;721.160 1 ppb of the PMN substance in surface include histopathological examination (see Unit VI.). waters. As described in the PMN, of the eyes by both light and electron In the other 46 cases, where the uses releases of the PMN substance to surface microscopy) would help characterize are not regulated under a TSCA section waters are not expected. Therefore, EPA the health effects of the PMN substance. 5(e) consent order, EPA determined that has not determined that the proposed CFR citation: 40 CFR 721.10692. one or more of the criteria of concern

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established at § 14;721.170 were met, as This rule establishes SNURs for a 1990 for a more detailed discussion of discussed in Unit IV. number of chemical substances. Any the cutoff date for ongoing uses. person who submits adverse or critical B. Objectives VIII. Test Data and Other Information comments, or notice of intent to submit EPA is issuing these SNURs for adverse or critical comments, must EPA recognizes that TSCA section 5 specific chemical substances which identify the chemical substance and the does not require developing any have undergone premanufacture review new use to which it applies. EPA will particular test data before submission of because the Agency wants to achieve not withdraw a SNUR for a chemical a SNUN. The two exceptions are: the following objectives with regard to substance not identified in the 1. Development of test data is the significant new uses designated in comment. required where the chemical substance this rule: subject to the SNUR is also subject to a • EPA will receive notice of any VII. Applicability of the Significant test rule under TSCA section 4 (see person’s intent to manufacture, or New Use Designation TSCA section 5(b)(1)). process a listed chemical substance for To establish a significant new use, 2. Development of test data may be the described significant new use before EPA must determine that the use is not necessary where the chemical substance that activity begins. ongoing. The chemical substances has been listed under TSCA section • EPA will have an opportunity to subject to this rule have undergone 5(b)(4) (see TSCA section 5(b)(2)). review and evaluate data submitted in a premanufacture review. In cases where In the absence of a TSCA section 4 SNUN before the notice submitter EPA has not received a notice of test rule or a TSCA section 5(b)(4) begins manufacturing, or processing a commencement (NOC) and the chemical listing covering the chemical substance, listed chemical substance for the substance has not been added to the persons are required only to submit test described significant new use. TSCA Inventory, no person may data in their possession or control and • EPA will be able to regulate commence such activities without first to describe any other data known to or prospective manufacturers or processors submitting a PMN. Therefore, for reasonably ascertainable by them (see of a listed chemical substance before the chemical substances for which an NOC § 720.50). However, upon review of described significant new use of that has not been submitted EPA concludes PMNs and SNUNs, the Agency has the chemical substance occurs, provided that the designated significant new uses authority to require appropriate testing. that regulation is warranted pursuant to are not ongoing. In cases where EPA issued a TSCA TSCA sections 5(e), 5(f), 6, or 7. When chemical substances identified section 5(e) consent order that requires • EPA will ensure that all in this rule are added to the TSCA or recommends certain testing, Unit IV. manufacturers and processors of the Inventory, EPA recognizes that, before lists those tests. Unit IV. also lists same chemical substance that is subject the rule is effective, other persons might recommended testing for non-section to a TSCA section 5(e) consent order are engage in a use that has been identified 5(e) SNURs. Descriptions of tests are subject to similar requirements. as a significant new use. However, provided for informational purposes. Issuance of a SNUR for a chemical TSCA section 5(e) consent orders have EPA strongly encourages persons, before substance does not signify that the been issued for 7 of the 53 chemical performing any testing, to consult with chemical substance is listed on the substances, and the PMN submitters are the Agency pertaining to protocol TSCA Chemical Substance Inventory prohibited by the TSCA section 5(e) selection. To access the OCSPP test (TSCA Inventory). Guidance on how to consent orders from undertaking guidelines referenced in this document determine if a chemical substance is on activities which would be designated as electronically, please go to http:// the TSCA Inventory is available on the significant new uses. The identities of 5 www.epa.gov/ocspp and select ‘‘Test Internet at http://www.epa.gov/opptintr/ of the 53 chemical substances subject to Methods and Guidelines.’’ The existingchemicals/pubs/tscainventory/ this rule have been claimed as Organisation for Economic Co-operation index.html. confidential and EPA has received no and Development (OECD) test post-PMN bona fide submissions (per guidelines are available from the OECD VI. Direct Final Procedures §§ 720.25 and 721.11). Based on this, Bookshop at http:// EPA is issuing these SNURs as a the Agency believes that it is highly www.oecdbookshop.org or SourceOECD direct final rule, as described in unlikely that any of the significant new at http://www.sourceoecd.org. § 721.160(c)(3) and § 721.170(d)(4). In uses described in the regulatory text of In the TSCA section 5(e) consent accordance with § 721.160(c)(3)(ii) and this rule are ongoing. orders for several of the chemical § 721.170(d)(4)(i)(B), the effective date Therefore EPA designates August 7, substances regulated under this rule, of this rule is October 7, 2013 without 2013 as the cutoff date for determining EPA has established production volume further notice, unless EPA receives whether the new use is ongoing. Persons limits in view of the lack of data on the written adverse or critical comments, or who begin commercial manufacture or potential health and environmental notice of intent to submit adverse or processing of the chemical substances risks that may be posed by the critical comments before September 6, for a significant new use identified as of significant new uses or increased 2013. that date would have to cease any such exposure to the chemical substances. If EPA receives written adverse or activity upon the effective date of the These limits cannot be exceeded unless critical comments, or notice of intent to final rule. To resume their activities, the PMN submitter first submits the submit adverse or critical comments, on these persons would have to first results of toxicity tests that would one or more of these SNURs before comply with all applicable SNUR permit a reasoned evaluation of the September 6, 2013, EPA will withdraw notification requirements and wait until potential risks posed by these chemical the relevant sections of this direct final the notice review period, including any substances. Under recent TSCA section rule before its effective date. EPA will extensions, expires. If such a person met 5(e) consent orders, each PMN submitter then issue a proposed SNUR for the the conditions of advance compliance is required to submit each study at least chemical substance(s) on which adverse under § 721.45(h), the person would be 14 weeks (earlier TSCA section 5(e) or critical comments were received, considered exempt from the consent orders required submissions at providing a 30-day period for public requirements of the SNUR. Consult the least 12 weeks) before reaching the comment. Federal Register document of April 24, specified production limit. Listings of

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the tests specified in the TSCA section fide submission would be a significant entitled ‘‘Regulatory Planning and 5(e) consent orders are included in Unit new use under the rule. Since most of Review’’ (58 FR 51735, October 4, 1993). IV. The SNURs contain the same the chemical identities of the chemical production volume limits as the TSCA substances subject to these SNURs are B. Paperwork Reduction Act (PRA) section 5(e) consent orders. Exceeding also CBI, manufacturers and processors According to PRA (44 U.S.C. 3501 et these production limits is defined as a can combine the bona fide submission seq.), an agency may not conduct or significant new use. Persons who intend under the procedure in sponsor, and a person is not required to to exceed the production limit must § 14;721.1725(b)(1) with that under respond to a collection of information notify the Agency by submitting a § 14;721.11 into a single step. that requires OMB approval under PRA, SNUN at least 90 days in advance of If EPA determines that the use unless it has been approved by OMB commencement of non-exempt identified in the bona fide submission and displays a currently valid OMB commercial manufacture or processing. would not be a significant new use, i.e., The recommended tests specified in control number. The OMB control the use does not meet the criteria numbers for EPA’s regulations in title 40 Unit IV. may not be the only means of specified in the rule for a significant addressing the potential risks of the of the CFR, after appearing in the new use, that person can manufacture or Federal Register, are listed in 40 CFR chemical substance. However, process the chemical substance so long submitting a SNUN without any test part 9, and included on the related as the significant new use trigger is not collection instrument or form, if data may increase the likelihood that met. In the case of a production volume EPA will take action under TSCA applicable. EPA is amending the table in trigger, this means that the aggregate 40 CFR part 9 to list the OMB approval section 5(e), particularly if satisfactory annual production volume does not number for the information collection test results have not been obtained from exceed that identified in the bona fide requirements contained in this rule. a prior PMN or SNUN submitter. EPA submission to EPA. Because of This listing of the OMB control numbers recommends that potential SNUN confidentiality concerns, EPA does not and their subsequent codification in the submitters contact EPA early enough so typically disclose the actual production CFR satisfies the display requirements that they will be able to conduct the volume that constitutes the use trigger. of PRA and OMB’s implementing appropriate tests. Thus, if the person later intends to regulations at 5 CFR part 1320. This SNUN submitters should be aware exceed that volume, a new bona fide Information Collection Request (ICR) that EPA will be better able to evaluate submission would be necessary to was previously subject to public notice SNUNs which provide detailed determine whether that higher volume and comment prior to OMB approval, information on the following: would be a significant new use. • Human exposure and and given the technical nature of the environmental release that may result X. SNUN Submissions table, EPA finds that further notice and from the significant new use of the According to § 721.1(c), persons comment to amend it is unnecessary. As chemical substances. a result, EPA finds that there is ‘‘good • submitting a SNUN must comply with Potential benefits of the chemical the same notification requirements and cause’’ under section 553(b)(3)(B) of the substances. Administrative Procedure Act (5 U.S.C. • EPA regulatory procedures as persons Information on risks posed by the submitting a PMN, including 553(b)(3)(B)) to amend this table chemical substances compared to risks submission of test data on health and without further notice and comment. posed by potential substitutes. environmental effects as described The information collection IX. Procedural Determinations in§ 720.50. SNUNs must be submitted requirements related to this action have By this rule, EPA is establishing on EPA Form No. 7710–25, generated already been approved by OMB certain significant new uses which have using e-PMN software, and submitted to pursuant to PRA under OMB control been claimed as CBI subject to Agency the Agency in accordance with the number 2070–0012 (EPA ICR No. 574). confidentiality regulations at 40 CFR procedures set forth in §§ 720.40 and This action does not impose any burden part 2 and 40 CFR part 720, subpart E. 721.25. E–PMN software is available requiring additional OMB approval. If Absent a final determination or other electronically at http://www.epa.gov/ an entity were to submit a SNUN to the disposition of the confidentiality claim opptintr/newchems. Agency, the annual burden is estimated to average between 30 and 170 hours under 40 CFR part 2 procedures, EPA is XI. Economic Analysis required to keep this information per response. This burden estimate EPA has evaluated the potential costs confidential. EPA promulgated a includes the time needed to review of establishing SNUN requirements for procedure to deal with the situation instructions, search existing data potential manufacturers and processors where a specific significant new use is sources, gather and maintain the data of the chemical substances subject to CBI, at 40 CFR 721.1725(b)(1). needed, and complete, review, and Under these procedures a this rule. EPA’s complete economic submit the required SNUN. manufacturer or processor may request analysis is available in the docket under Send any comments about the EPA to determine whether a proposed docket ID number EPA–HQ–OPPT– accuracy of the burden estimate, and use would be a significant new use 2013–0399. any suggested methods for minimizing under the rule. The manufacturer or XII. Statutory and Executive Order respondent burden, including through processor must show that it has a bona Reviews the use of automated collection fide intent to manufacture or process the techniques, to the Director, Collection chemical substance and must identify A. Executive Order 12866 Strategies Division, Office of the specific use for which it intends to This rule establishes SNURs for Environmental Information (2822T), manufacture or process the chemical several new chemical substances that Environmental Protection Agency, 1200 substance. If EPA concludes that the were the subject of PMNs, or TSCA Pennsylvania Ave. NW., Washington, person has shown a bona fide intent to section 5(e) consent orders. The Office DC 20460–0001. Please remember to manufacture or process the chemical of Management and Budget (OMB) has include the OMB control number in any substance, EPA will tell the person exempted these types of actions from correspondence, but do not submit any whether the use identified in the bona review under Executive Order 12866, completed forms to this address.

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C. Regulatory Flexibility Act (RFA) communities of Indian Tribal 40 CFR Part 721 On February 18, 2012, EPA certified governments, nor does it involve or Environmental protection, Chemicals, pursuant to RFA section 605(b) (5 U.S.C. impose any requirements that affect Hazardous substances, Reporting and 601 et seq.), that promulgation of a Indian Tribes. Accordingly, the recordkeeping requirements. SNUR does not have a significant requirements of Executive Order 13175, entitled ‘‘Consultation and Coordination Dated: July 30, 2013. economic impact on a substantial Maria J. Doa, number of small entities where the with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000), do not apply Director, Chemical Control Division, Office following are true: of Pollution Prevention and Toxics. 1. A significant number of SNUNs to this rule. Therefore, 40 CFR parts 9 and 721 are would not be submitted by small G. Executive Order 13045 amended as follows: entities in response to the SNUR. This action is not subject to Executive 2. The SNUR submitted by any small PART 9—[AMENDED] entity would not cost significantly more Order 13045, entitled ‘‘Protection of than $8,300. Children from Environmental Health ■ 1. The authority citation for part 9 A copy of that certification is available Risks and Safety Risks’’ (62 FR 19885, continues to read as follows: in the docket for this rule. April 23, 1997), because this is not an economically significant regulatory Authority: 7 U.S.C. 135 et seq., 136–136y; This rule is within the scope of the 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; February 18, 2012 certification. Based action as defined by Executive Order 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 on the Economic Analysis discussed in 12866, and this action does not address U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, Unit XI. and EPA’s experience environmental health or safety risks 1321, 1326, 1330, 1342, 1344, 1345(d) and promulgating SNURs (discussed in the disproportionately affecting children. (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975 Comp. p. 973; 42 U.S.C. 241, certification), EPA believes that the H. Executive Order 13211 following are true: 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, • A significant number of SNUNs This action is not subject to Executive 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, would not be submitted by small Order 13211, entitled ‘‘Actions 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 6901–6992k, 7401–7671q, 7542, 9601–9657, entities in response to the SNUR. Concerning Regulations That 11023, 11048. • Submission of the SNUN would not Significantly Affect Energy Supply, ■ 2. In § 9.1, add the following sections cost any small entity significantly more Distribution, or Use’’ (66 FR 28355, May in numerical order under the than $8,300. 22, 2001), because this action is not undesignated center heading Therefore, the promulgation of the expected to affect energy supply, ‘‘Significant New Uses of Chemical SNUR would not have a significant distribution, or use and because this Substances’’ to read as follows: economic impact on a substantial action is not a significant regulatory number of small entities. action under Executive Order 12866. § 9.1 OMB approvals under the Paperwork Reduction Act. D. Unfunded Mandates Reform Act I. National Technology Transfer and (UMRA) Advancement Act (NTTAA) * * * * * Based on EPA’s experience with In addition, since this action does not 40 CFR citation OMB proposing and finalizing SNURs, State, involve any technical standards, control No. local, and Tribal governments have not NTTAA section 12(d) (15 U.S.C. 272 been impacted by these rulemakings, note), does not apply to this action. and EPA does not have any reasons to believe that any State, local, or Tribal J. Executive Order 12898 ***** government will be impacted by this Significant New Uses of Chemical This action does not entail special Substances rule. As such, EPA has determined that considerations of environmental justice this rule does not impose any related issues as delineated by enforceable duty, contain any unfunded Executive Order 12898, entitled mandate, or otherwise have any effect ‘‘Federal Actions to Address ***** on small governments subject to the Environmental Justice in Minority 721.10671 ...... 2070–0012 721.10672 ...... 2070–0012 requirements of UMRA sections 202, Populations and Low-Income 203, 204, or 205 (2 U.S.C. 1501 et seq.). 721.10673 ...... 2070–0012 Populations’’ (59 FR 7629, February 16, 721.10674 ...... 2070–0012 E. Executive Order 13132 1994). 721.10675 ...... 2070–0012 XIII. Congressional Review Act 721.10676 ...... 2070–0012 This action will not have a substantial 721.10677 ...... 2070–0012 direct effect on States, on the Pursuant to the Congressional Review 721.10678 ...... 2070–0012 relationship between the national Act (5 U.S.C. 801 et seq.), EPA will 721.10679 ...... 2070–0012 government and the States, or on the submit a report containing this rule and 721.10680 ...... 2070–0012 distribution of power and other required information to the U.S. 721.10681 ...... 2070–0012 responsibilities among the various Senate, the U.S. House of 721.10682 ...... 2070–0012 levels of government, as specified in 721.10683 ...... 2070–0012 Representatives, and the Comptroller 721.10684 ...... 2070–0012 Executive Order 13132, entitled General of the United States prior to ‘‘Federalism’’ (64 FR 43255, August 10, 721.10685 ...... 2070–0012 publication of the rule in the Federal 721.10686 ...... 2070–0012 1999). Register. This action is not a ‘‘major 721.10687 ...... 2070–0012 F. Executive Order 13175 rule’’ as defined by 5 U.S.C. 804(2). 721.10688 ...... 2070–0012 721.10689 ...... 2070–0012 This rule does not have Tribal List of Subjects 721.10690 ...... 2070–0012 implications because it is not expected 40 CFR Part 9 721.10691 ...... 2070–0012 to have substantial direct effects on 721.10692 ...... 2070–0012 Indian Tribes. This rule does not Environmental protection, Reporting 721.10693 ...... 2070–0012 significantly nor uniquely affect the and recordkeeping requirements.

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provisions of § 721.185 apply to this (2) The significant new uses are: 40 CFR citation OMB control No. section. (i) Industrial, commercial, and (3) Determining whether a specific use ***** consumer activities. Requirements as is subject to this section. The provisions specified in § 721.80. A significant new of § 721.1725(b)(1) apply to paragraph * * * * * use is manufacture of the PMN (a)(2)(ii) of this section. substance with greater than 1 weight ■ PART 721—[AMENDED] 5. Add § 721.10672 to subpart E to percent (‘‘wt%’’) of chlorinated (‘‘Cl’’) read as follows: paraffins with an alkyl chain ≤ 20 and ■ 3. The authority citation for part 721 § 721.10672 Sodium olefin sulfonate § 721.80(r) (Testing phase 1 is reached at continues to read as follows: derivative (generic). 1,200,000 kg for the aggregate of the Authority: 15 U.S.C. 2604, 2607, and (a) Chemical substances and PMN substances P–12–539, P–13–107, 2625(c). significant new uses subject to reporting. and P–13–109. Testing includes analysis ■ 4. Add § 721.10671 to subpart E to (1) The chemical substances identified for chain length and percent read as follows: generically as sodium olefin sulfonate chlorination (for example by gas § 721.10671 Multi-walled carbon derivative (PMNs P–09–447 and P–09– chromatography-mass spectrometry or nanotubes (generic). 448) are subject to reporting under this high performance liquid (a) Chemical substances and section for the significant new uses chromatography-mass spectrometry). significant new uses subject to reporting. described in paragraph (a)(2) of this Present EPA with a certificate of (1) The chemical substances identified section. The requirements of this rule do analysis and all raw data for congener generically as multi-walled carbon not apply to quantities of the chemical analysis on P–12–539, P–13–107, and nanotubes (PMNs P–09–198 and P–09– substances after they have been P–13–109. Testing phase 2a is reached 199) are subject to reporting under this completely reacted (cured) or at 14,100,000 kg for the aggregate of the section for the significant new uses partitioned into oil or petroleum PMN substances P–12–539, P–13–107, described in paragraph (a)(2) of this streams following use as specific and P–13–109. Testing includes a section. The requirements of this rule do enhanced oil recovery applications that modified semi-continuous activated not apply to quantities of the PMN have been claimed confidential. sludge (SCAS) test or modified SCAS substances after they have been (2) The significant new uses are: test for insoluble and volatile chemicals (i) Hazard communication program. completely reacted (cured); embedded or Zahn Wellens test with analytical Requirements as specified in § 721.72 or incorporated into a polymer matrix procedures capable of measuring (a), (b), (c). (d), (e) (concentration set at that itself has been reacted (cured); or individual congeners and degradation embedded in a permanent solid polymer 1.0 percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). products over time on three chlorinated form that is not intended to undergo linear C21 paraffin fractions to represent further processing, except mechanical (ii) Industrial, commercial, and consumer activities. Requirements as each of the 40%, 55%, and > 70% processing. chlorine by weight, three chlorinated (2) The significant new uses are: specified in § 721.80(k). (i) Protection in the workplace. (iii) Release to water. Requirements as C26 linear paraffin fractions to represent Requirements as specified in § 721.63 specified in § 721.90 (a)(4), (b)(4), and each of the 40%, 55%, and > 70% (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4) (c)(4) (N=10). chlorine by weight, three chlorinated (National Institute of Occupational (b) Specific requirements. The linear paraffin fractions, whose chain Safety and Health (NIOSH)-certified air- provisions of subpart A of this part length represents the central tendency purifying, tight-fitting full-face apply to this section except as modified of the congener distribution of the very respirator equipped with N100 filters), by this paragraph. long chain chlorinated paraffins (a)(6)(i), and (c). When determining (1) Recordkeeping. Recordkeeping (vLCCP) product as identified in testing which persons are reasonably likely to requirements as specified in § 721.125 phase 1, to represent each of the 40%, be exposed as required for § 721.63 (a), (b), (c), (f), (g), (h), (i), and (k) are 55%, and > 70% chlorine by weight. (a)(1) and (a)(4), engineering control applicable to manufacturers and Testing phase 2b is reached at measures (e.g., enclosure or processors of these substances. 59,100,000 kg for the aggregate of the confinement of the operation, general (2) Limitations or revocation of PMN substances P–12–539, P–13–107, and local ventilation) or administrative certain notification requirements. The and P–13–109. Testing includes aerobic control measures (e.g., workplace provisions of § 721.185 apply to this and anaerobic transformation in soil test policies and procedures) shall be section. with analytical procedures capable of (3) Determining whether a specific use considered and implemented to prevent measuring individual congeners and is subject to this section. The provisions exposure, where feasible. degradation products over time and of § 721.1725(b)(1) apply to paragraph (ii) Industrial, commercial, and bioaccumulation in sediment-dwelling (a)(1) of this section. consumer activities. Requirements as benthic oligochaetes on three ■ specified in § 721.80 (f), (k), and (q). 6. Add § 721.10673 to subpart E to chlorinated linear C21 paraffin fractions (iii) Release to water. Requirements as read as follows: to represent each of the 40%, 55%, and specified in § 721.90 (b)(1) and (c)(1). > 70% chlorine by weight, three (b) Specific requirements. The § 721.10673 Alkanes, C21–34—branched chlorinated C26 linear paraffin fractions provisions of subpart A of this part and linear, chloro. apply to this section except as modified (a) Chemical substance and to represent each of the 40%, 55%, and by this paragraph. significant new uses subject to reporting. > 70% chlorine by weight, three (1) Recordkeeping. Recordkeeping (1) The chemical substance identified as chlorinated linear paraffin fractions, requirements as specified in § 721.125 alkanes, C21–34—branched and linear, whose chain length represents the (a), (b), (c), (d), (e), (i), and (k) are chloro (PMN P–12–539; CAS No. central tendency of the congener applicable to manufacturers and 1417900–96–9) is subject to reporting distribution of the vLCCP product as processors of these substances. under this section for the significant identified in testing phase 1, to (2) Limitations or revocation of new uses described in paragraph (a)(2) represent each of the 40%, 55%, and certain notification requirements. The of this section.

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phase 3 is reached at 78,400,000 kg for use is manufacture of the PMN testing phase 2a the sediment-water the aggregate of the PMN substances P– substance with greater than 1 weight chironomid life-cycle toxicity test using 12–539, P–13–107, and P–13–109. If the percent (‘‘wt%’’) of chlorinated (‘‘Cl’’) spiked water or spiked sediment is an degradation half-life of the test paraffins with an alkyl chain ≤ 20 and acceptable test, otherwise sediment- substance is 28 days or shorter from § 721.80(r) (Testing phase 1 is reached at water lumbriculus toxicity test using testing phase 2a the sediment-water 1,200,000 kg for the aggregate of the spiked sediment is an acceptable test for chironomid life-cycle toxicity test using PMN substances P–12–539, P–13–107, any of the parent substances that are spiked water or spiked sediment is an and P–13–109. Testing includes analysis absorbed by the benthic oligochaetes in acceptable test, otherwise sediment- for chain length and percent the bioaccumulation in sediment- water lumbriculus toxicity test using chlorination (for example by gas dwelling benthic oligochaetes test. In spiked sediment is an acceptable test for chromatography-mass spectrometry or the bioaccumulation in sediment- any of the parent substances that are high performance liquid dwelling benthic oligochaetes test, use absorbed by the benthic oligochaetes in chromatography-mass spectrometry). as test material any of the degradation the bioaccumulation in sediment- Present EPA with a certificate of products in testing phases 2a or 2b that dwelling benthic oligochaetes test. In analysis and all raw data for congener are identified to potentially present an the bioaccumulation in sediment- analysis on P–12–539, P–13–107, and unreasonable risk or to further degrade dwelling benthic oligochaetes test, use P–13–109. Testing phase 2a is reached to generate a substance of potential as test material any of the degradation at 14,100,000 kg for the aggregate of the concern. Testing phase 4 is reached at products in testing phases 2a or 2b that PMN substances P–12–539, P–13–107, 86,100,000 kg for the aggregate of the are identified to potentially present an and P–13–109. Testing includes a PMN substances P–12–539, P–13–107, unreasonable risk or to further degrade modified semi-continuous activated and P–13–109. If the degradation half- to generate a substance of potential sludge (SCAS) test or modified SCAS life of the test substance is 28 days or concern. Testing phase 4 is reached at test for insoluble and volatile chemicals shorter from testing phase 3 the 86,100,000 kg for the aggregate of the or Zahn Wellens test with analytical sediment-water chironomid life-cycle PMN substances P–12–539, P–13–107, procedures capable of measuring toxicity test using spiked water or and P–13–109. If the degradation half- individual congeners and degradation spiked sediment is an acceptable test, life of the test substance is 28 days or products over time on three chlorinated otherwise the sediment-water shorter from testing phase 3 the linear C21 paraffin fractions to represent lumbriculus toxicity test using spiked sediment-water chironomid life-cycle each of the 40%, 55%, and > 70% sediment is an acceptable test. Use toxicity test using spiked water or chlorine by weight, three chlorinated degradation substances in testing phase spiked sediment is an acceptable test, C26 linear paraffin fractions to represent 3 that are absorbed by the benthic otherwise the sediment-water each of the 40%, 55%, and > 70% oligochaetes as the test material.) lumbriculus toxicity test using spiked chlorine by weight, three chlorinated (ii) [Reserved] sediment is an acceptable test. Use linear paraffin fractions, whose chain (b) Specific requirements. The degradation substances in testing phase length represents the central tendency provisions of subpart A of this part 3 that are absorbed by the benthic of the congener distribution of the very apply to this section except as modified oligochaetes as the test material.) long chain chlorinated paraffins by this paragraph. (ii) [Reserved] (vLCCP) product as identified in testing (1) Recordkeeping. Recordkeeping (b) Specific requirements. The phase 1, to represent each of the 40%, requirements as specified in § 721.125 provisions of subpart A of this part 55%, and > 70% chlorine by weight. (a), (b), (c), and (i) are applicable to apply to this section except as modified Testing phase 2b is reached at manufacturers and processors of this by this paragraph. 59,100,000 kg for the aggregate of the substance. (1) Recordkeeping. Recordkeeping PMN substances P–12–539, P–13–107, (2) Limitations or revocation of requirements as specified in § 721.125 and P–13–109. Testing includes aerobic certain notification requirements. The (a), (b), (c), and (i) are applicable to and anaerobic transformation in soil test provisions of § 721.185 apply to this manufacturers and processors of this with analytical procedures capable of section. substance. (2) Limitations or revocation of measuring individual congeners and ■ 8. Add § 721.10675 to subpart E to certain notification requirements. The degradation products over time and read as follows: bioaccumulation in sediment-dwelling provisions of § 721.185 apply to this § 721.10675 Alkanes, C24–28, chloro. section. benthic oligochaetes on three (a) Chemical substance and ■ chlorinated linear C21 paraffin fractions 7. Add § 721.10674 to subpart E to to represent each of the 40%, 55%, and significant new uses subject to reporting. read as follows: > 70% chlorine by weight, three (1) The chemical substance identified as § 721.10674 Alkanes, C22–30—branched chlorinated C26 linear paraffin fractions alkanes, C24–28, chloro (PMN P–13– and linear, chloro. to represent each of the 40%, 55%, and 109; CAS No. 1402738–52–6) is subject (a) Chemical substance and > 70% chlorine by weight, three to reporting under this section for the significant new uses subject to reporting. chlorinated linear paraffin fractions, significant new uses described in (1) The chemical substance identified as whose chain length represents the paragraph (a)(2) of this section. alkanes, C22–30—branched and linear, central tendency of the congener (2) The significant new uses are: chloro (PMN P–13–107; CAS No. distribution of the vLCCP product as (i) Industrial, commercial, and 1401947–24–0) is subject to reporting identified in testing phase 1, to consumer activities. Requirements as under this section for the significant represent each of the 40%, 55%, and > specified in § 721.80. A significant new new uses described in paragraph (a)(2) 70% chlorine by weight. Testing phase use is manufacture of the PMN of this section. 3 is reached at 78,400,000 kg for the substance with greater than 1 weight (2) The significant new uses are: aggregate of the PMN substances P–12– percent (‘‘wt%’’) of chlorinated (‘‘Cl’’) (i) Industrial, commercial, and 539, P–13–107, and P–13–109. If the paraffins with an alkyl chain ≤ 20 and consumer activities. Requirements as degradation half-life of the test § 721.80(r) (Testing phase 1 is reached at specified in § 721.80. A significant new substance is 28 days or shorter from 1,200,000 kg for the aggregate of the

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PMN substances P–12–539, P–13–107, any of the parent substances that are provisions of § 721.185 apply to this and P–13–109. Testing includes analysis absorbed by the benthic oligochaetes in section. for chain length and percent the bioaccumulation in sediment- ■ 10. Add § 721.10677 to subpart E to chlorination (for example by gas dwelling benthic oligochaetes test. In read as follows: chromatography-mass spectrometry or the bioaccumulation in sediment- high performance liquid dwelling benthic oligochaetes test, use § 721.10677 Alkyl phosphonate (generic). chromatography-mass spectrometry). as test material any of the degradation (a) Chemical substance and Present EPA with a certificate of products in testing phases 2a or 2b that significant new uses subject to reporting. analysis and all raw data for congener are identified to potentially present an (1) The chemical substance identified analysis on P–12–539, P–13–107, and unreasonable risk or to further degrade generically as alkyl phosphonate (PMN P–13–109. Testing phase 2a is reached to generate a substance of potential P–12–584) is subject to reporting under at 14,100,000 kg for the aggregate of the concern. Testing phase 4 is reached at this section for the significant new uses PMN substances P–12–539, P–13–107, 86,100,000 kg for the aggregate of the described in paragraph (a)(2) of this and P–13–109. Testing includes a PMN substances P–12–539, P–13–107, section. modified semi-continuous activated and P–13–109. If the degradation half- (2) The significant new uses are: sludge (SCAS) test or modified SCAS life of the test substance is 28 days or (i) Industrial, commercial, and test for insoluble and volatile chemicals shorter from testing phase 3 the consumer activities. Requirements as or Zahn Wellens test with analytical sediment-water chironomid life-cycle specified in § 721.80(g). procedures capable of measuring toxicity test using spiked water or (ii) Protection in the workplace. individual congeners and degradation spiked sediment is an acceptable test, Requirements as specified in § 721.63 products over time on three chlorinated otherwise the sediment-water (a)(1), (a)(2)(i), and (a)(3). When linear C21 paraffin fractions to represent lumbriculus toxicity test using spiked determining which persons are each of the 40%, 55%, and > 70% sediment is an acceptable test. Use reasonably likely to be exposed as chlorine by weight, three chlorinated degradation substances in testing phase required for § 721.63 (a)(1) and (a)(4), C26 linear paraffin fractions to represent 3 that are absorbed by the benthic engineering control measures (e.g., each of the 40%, 55%, and > 70% oligochaetes as the test material.) enclosure or confinement of the chlorine by weight, three chlorinated (ii) [Reserved] operation, general and local ventilation) linear paraffin fractions, whose chain (b) Specific requirements. The or administrative control measures (e.g., length represents the central tendency provisions of subpart A of this part workplace policies and procedures) of the congener distribution of the very apply to this section except as modified shall be considered and implemented to long chain chlorinated paraffins by this paragraph. prevent exposure, where feasible. (vLCCP) product as identified in testing (1) Recordkeeping. Recordkeeping (iii) Release to water. Requirements as phase 1, to represent each of the 40%, requirements as specified in § 721.125 specified in § 721.90 (a)(4), (b)(4), and 55%, and > 70% chlorine by weight. (a), (b), (c), and (i) are applicable to (c)(4) (N=1). (b) Specific requirements. The Testing phase 2b is reached at manufacturers and processors of this provisions of subpart A of this part 59,100,000 kg for the aggregate of the substance. apply to this section except as modified PMN substances P–12–539, P–13–107, (2) Limitations or revocation of by this paragraph. and P–13–109. Testing includes aerobic certain notification requirements. The (1) Recordkeeping. Recordkeeping and anaerobic transformation in soil test provisions of § 721.185 apply to this requirements as specified in § 721.125 with analytical procedures capable of section. ■ (a), (b), (c), (d), (e), (i), and (k) are measuring individual congeners and 9. Add § 721.10676 to subpart E to applicable to manufacturers and degradation products over time and read as follows: processors of this substance. bioaccumulation in sediment-dwelling § 721.10676 Aromatic hydrocarbon (2) Limitations or revocation of benthic oligochaetes on three mixture (generic). certain notification requirements. The chlorinated linear C21 paraffin fractions (a) Chemical substance and provisions of § 721.185 apply to this to represent each of the 40%, 55%, and significant new uses subject to reporting. section. > 70% chlorine by weight, three (1) The chemical substance identified ■ chlorinated C26 linear paraffin fractions 11. Add § 721.10678 to subpart E to generically as aromatic hydrocarbon read as follows: to represent each of the 40%, 55%, and mixture (PMN P–12–551) is subject to > 70% chlorine by weight, three reporting under this section for the § 721.10678 1,4-Cyclohexanedicarboxylic chlorinated linear paraffin fractions, significant new uses described in acid, 1,4-dimethyl ester, hydrogenolysis whose chain length represents the paragraph (a)(2) of this section. products. central tendency of the congener (2) The significant new uses are: (a) Chemical substance and distribution of the vLCCP product as (i) Release to water. Requirements as significant new uses subject to reporting. identified in testing phase 1, to specified in § 721.90 (a)(4), (b)(4), and (1) The chemical substance identified as represent each of the 40%, 55%, and > (c)(4) (N=78). 1,4-cyclohexanedicarboxylic acid, 1,4- 70% chlorine by weight. Testing phase (ii) [Reserved] dimethyl ester, hydrogenolysis products 3 is reached at 78,400,000 kg for the (b) Specific requirements. The (PMN P–13–10; CAS No. 1373220–73–5) aggregate of the PMN substances P–12– provisions of subpart A of this part is subject to reporting under this section 539, P–13–107, and P–13–109. If the apply to this section except as modified for the significant new uses described in degradation half-life of the test by this paragraph. paragraph (a)(2) of this section. substance is 28 days or shorter from (1) Recordkeeping. Recordkeeping (2) The significant new uses are: testing phase 2a the sediment-water requirements as specified in § 721.125 (i) Release to water. Requirements as chironomid life-cycle toxicity test using (a), (b), (c), and (k) are applicable to specified in § 721.90 (a)(4), (b)(4), and spiked water or spiked sediment is an manufacturers and processors of this (c)(4) (N=20). acceptable test, otherwise sediment- substance. (ii) [Reserved] water lumbriculus toxicity test using (2) Limitations or revocation of (b) Specific requirements. The spiked sediment is an acceptable test for certain notification requirements. The provisions of subpart A of this part

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apply to this section except as modified under this section for the significant § 721.10682 Fatty acid amide by this paragraph. new uses described in paragraph (a)(2) hydrochlorides (generic). (1) Recordkeeping. Recordkeeping of this section. (a) Chemical substances and requirements as specified in § 721.125 (2) The significant new uses are: significant new uses subject to reporting. (a), (b), (c), and (k) are applicable to (i) Industrial, commercial, and (1) The chemical substances identified manufacturers and processors of this consumer activities. Requirements as generically as fatty acid amide substance. specified in § 721.80. A significant new hydrochlorides (PMNs P–13–63, P–13– (2) Limitations or revocation of use is any use other than as adhesion 64, P–13–65, P–13–69, P–13–70, P–13– certain notification requirements. The promoters for asphalt applications or 71, P–13–72, P–13–73, P–13–74, P–13– provisions of § 721.185 apply to this emulsifiers for asphalt applications. 75, P–13–76, and P–13–77) are subject section. (ii) [Reserved] to reporting under this section for the ■ 12. Add § 721.10679 to subpart E to (b) Specific requirements. The significant new uses described in read as follows: provisions of subpart A of this part paragraph (a)(2) of this section. § 721.10679 Carboxylic acid, substituted apply to this section except as modified (2) The significant new uses are: alkylstannylene ester, reaction products by this paragraph. (i) Industrial, commercial, and with inorganic acid tetra alkyl ester (1) Recordkeeping. Recordkeeping consumer activities. Requirements as (generic). requirements as specified in § 721.125 specified in § 721.80. A significant new (a) Chemical substance and (a), (b), (c), and (i) are applicable to use is any use other than as surfactants significant new uses subject to reporting. manufacturers and processors of this for use in asphalt emulsions. (1) The chemical substance identified substance. (ii) [Reserved] generically as carboxylic acid, (2) Limitations or revocation of (b) Specific requirements. The substituted alkylstannylene ester, certain notification requirements. The provisions of subpart A of this part reaction products with inorganic acid provisions of § 721.185 apply to this apply to this section except as modified tetra alkyl ester (PMN P–13–30) is section. by this paragraph. subject to reporting under this section ■ (1) Recordkeeping. Recordkeeping for the significant new uses described in 14. Add § 721.10681 to subpart E to read as follows: requirements as specified in § 721.125 paragraph (a)(2) of this section. (a), (b), (c), and (i) are applicable to (2) The significant new uses are: § 721.10681 Alkaneamide, halo- manufacturers and processors of these (i) Industrial, commercial, and dialkylthienyl-alkoxydialkyl-, manuf. of by- substances. consumer activities. Requirements as products from (generic). (2) Limitations or revocation of specified in § 721.80(o). (a) Chemical substance and certain notification requirements. The (ii) Protection in the workplace. significant new uses subject to reporting. provisions of § 721.185 apply to this Requirements as specified in § 721.63 (1) The chemical substances identified section. (a)(1), (a)(2)(i), (a)(3), (b) (concentration generically as alkaneamide, halo- set at 1.0%), and (c). When determining ■ 16. Add § 721.10683 to subpart E to dialkylthienyl-alkoxydialkyl-, manuf. of which persons are reasonably likely to read as follows: by-products from (PMNs P–13–55 and be exposed as required for § 721.63 PMN P–13–56) are subject to reporting § 721.10683 Dialkylamino cocoalkyl (a)(1) and (a)(4), engineering control under this section for the significant alkylamide acid salt (generic). measures (e.g., enclosure or new uses described in paragraph (a)(2) confinement of the operation, general (a) Chemical substance and of this section. and local ventilation) or administrative significant new uses subject to reporting. control measures (e.g., workplace (2) The significant new uses are: (1) The chemical substance identified policies and procedures) shall be (i) Industrial, commercial, and generically as dialkylamino cocoalkyl considered and implemented to prevent consumer activities. Requirements as alkylamide acid salt (PMN P–13–131) is exposure, where feasible. specified in § 721.80(j). subject to reporting under this section (b) Specific requirements. The (ii) Release to water. Requirements as for the significant new uses described in provisions of subpart A of this part specified in § 721.90 (a)(4), (b)(4), and paragraph (a)(2) of this section. apply to this section except as modified (c)(4) (N=1). (2) The significant new uses are: by this paragraph. (b) Specific requirements. The (i) Release to water. Requirements as (1) Recordkeeping. Recordkeeping provisions of subpart A of this part specified in § 721.90 (a)(4), (b)(4), and requirements as specified in § 721.125 apply to this section except as modified (c)(4) (N=1). (a), (b), (c), (d), and (e) are applicable to by this paragraph. (ii) [Reserved] manufacturers and processors of this (1) Recordkeeping. Recordkeeping (b) Specific requirements. The substance. requirements as specified in § 721.125 provisions of subpart A of this part (2) Limitations or revocation of (a), (b), (c), (i) and (k) are applicable to apply to this section except as modified certain notification requirements. The manufacturers and processors of these by this paragraph. provisions of § 721.185 apply to this substances. (1) Recordkeeping. Recordkeeping section. (2) Limitations or revocation of requirements as specified in § 721.125 ■ 13. Add § 721.10680 to subpart E to certain notification requirements. The (a), (b), (c), and (k) are applicable to read as follows: provisions of § 721.185 apply to this manufacturers and processors of this § 721.10680 Fatty acid amides (generic). section. substance. (a) Chemical substance and (3) Determining whether a specific use (2) Limitations or revocation of significant new uses subject to reporting. is subject to this section. The provisions certain notification requirements. The (1) The chemical substances identified of § 721.1725(b)(1) apply to paragraph provisions of § 721.185 apply to this generically as fatty acid amides (PMNs (a)(2)(i) of this section. section. P–13–44, P–13–46, P–13–47, P–13–50, ■ 15. Add § 721.10682 to subpart E to ■ 17. Add § 721.10684 to subpart E to and P–13–51) are subject to reporting read as follows: read as follows:

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§ 721.10684 Substituted benzenamine P–13–180, P–13–181, P–13–182, P–13– (1) The chemical substance identified as schiff base (generic). 183, P–13–184, and P–13–185) are copper, chloro[tris(2-chloroethyl) (a) Chemical substance and subject to reporting under this section phosphite-.kappa.P]- (PMN P–13–221; significant new uses subject to reporting. for the significant new uses described in CAS No. 24484–01–3) is subject to (1) The chemical substance identified paragraph (a)(2) of this section. reporting under this section for the generically as substituted benzenamine (2) The significant new uses are: significant new uses described in schiff base (PMN P–13–135) is subject to (i) Industrial, commercial, and paragraph (a)(2) of this section. reporting under this section for the consumer activities. Requirements as (2) The significant new uses are: significant new uses described in specified in § 721.80. A significant new (i) Industrial, commercial, and paragraph (a)(2) of this section. use is any use other than as adhesion consumer activities. Requirements as (2) The significant new uses are: promoters for asphalt applications or specified in § 721.80(j). (i) Release to water. Requirements as emulsifiers for asphalt applications. specified in § 721.90 (a)(4), (b)(4), and (ii) [Reserved] (ii) Release to water. Requirements as (c)(4) (N=1). (b) Specific requirements. The specified in § 721.90 (a)(4), (b)(4), and (ii) [Reserved] provisions of subpart A of this part (c)(4) (N=6). (b) Specific requirements. The apply to this section except as modified (b) Specific requirements. The provisions of subpart A of this part by this paragraph. provisions of subpart A of this part apply to this section except as modified (1) Recordkeeping. Recordkeeping apply to this section except as modified by this paragraph. requirements as specified in § 721.125 by this paragraph. (a), (b), (c), and (i) are applicable to (1) Recordkeeping. Recordkeeping (1) Recordkeeping. Recordkeeping manufacturers and processors of these requirements as specified in § 721.125 requirements as specified in § 721.125 substances. (a), (b), (c), and (k) are applicable to (a), (b), (c), (i), and (k) are applicable to (2) Limitations or revocation of manufacturers and processors of this manufacturers and processors of this certain notification requirements. The substance. substance. (2) Limitations or revocation of provisions of § 721.185 apply to this section. (2) Limitations or revocation of certain notification requirements. The certain notification requirements. The provisions of § 721.185 apply to this ■ 20. Add § 721.10687 to subpart E to read as follows: provisions of § 721.185 apply to this section. section. ■ 18. Add § 721.10685 to subpart E to § 721.10687 Fatty acid amide (3) Determining whether a specific use read as follows: hydrochlorides (generic). is subject to this section. The provisions § 721.10685 Phosphoric acid, mixed (a) Chemical substance and of § 721.1725(b)(1) apply to paragraph esters (generic). significant new uses subject to reporting. (a)(2)(i) of this section. (1) The chemical substances identified (a) Chemical substance and ■ generically as fatty acid amide 22. Add § 721.10689 to subpart E to significant new uses subject to reporting. hydrochlorides (PMNs P–13–201, P–13– read as follows: (1) The chemical substance identified 203, P–13–204, P–13–205, P–13–206, P– generically as phosphoric acid, mixed § 721.10689 Organo zinc salts (generic). 13–207, P–13–208, and P–13–209) are esters (PMN P–13–170) is subject to subject to reporting under this section (a) Chemical substance and reporting under this section for the for the significant new uses described in significant new uses subject to reporting. significant new uses described in paragraph (a)(2) of this section. (1) The chemical substance identified paragraph (a)(2) of this section. (2) The significant new uses are: generically as organo zinc salts (PMN P– (2) The significant new uses are: (i) Industrial, commercial, and 13–225) is subject to reporting under (i) Release to water. Requirements as consumer activities. Requirements as this section for the significant new uses specified in § 721.90 (a)(4), (b)(4), and specified in § 721.80. A significant new described in paragraph (a)(2) of this (c)(4) (N=1). use is any use other than as surfactants section. (ii) [Reserved] for asphalt emulsions. (2) The significant new uses are: (b) Specific requirements. The (ii) [Reserved] (i) Release to water. Requirements as provisions of subpart A of this part (b) Specific requirements. The apply to this section except as modified specified in § 721.90 (a)(4), (b)(4), and provisions of subpart A of this part (c)(4) (N=3). by this paragraph. apply to this section except as modified (1) Recordkeeping. Recordkeeping by this paragraph. (ii) [Reserved] requirements as specified in § 721.125 (1) Recordkeeping. Recordkeeping (b) Specific requirements. The (a), (b), (c), and (k) are applicable to requirements as specified in § 721.125 provisions of subpart A of this part manufacturers and processors of this (a), (b), (c), and (i) are applicable to apply to this section except as modified substance. manufacturers and processors of these by this paragraph. (2) Limitations or revocation of substances. (1) Recordkeeping. Recordkeeping certain notification requirements. The (2) Limitations or revocation of requirements as specified in § 721.125 provisions of § 721.185 apply to this certain notification requirements. The (a), (b), (c), and (k) are applicable to section. provisions of § 721.185 apply to this manufacturers and processors of this ■ 19. Add § 721.10686 to subpart E to section. substance. read as follows: ■ 21. Add § 721.10688 to subpart E to (2) Limitations or revocation of § 721.10686 Fatty acid amides (generic). read as follows: certain notification requirements. The provisions of § 721.185 apply to this (a) Chemical substance and § 721.10688 Copper, chloro[tris(2- section. significant new uses subject to reporting. chloroethyl) phosphite-.kappa.P]-. (1) The chemical substances identified (a) Chemical substance and ■ 23. Add § 721.10690 to subpart E to generically as fatty acid amides (PMNs significant new uses subject to reporting. read as follows:

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§ 721.10690 Benzenedicarboxylic acid, (2) Limitations or revocation of ENVIRONMENTAL PROTECTION polymer with substituted alkanediol, certain notification requirements. The AGENCY dodecanedioic acid, 1,2-ethanediol, provisions of § 721.185 apply to this alkanedioic acid, alkanediol,.alpha.-hydro- section. 40 CFR Part 180 .omega.-hydroxypoly[oxyalkanediyl], 1,3- ■ isobenzofurandione, methylene diphenyl 25. Add § 721.10692 to subpart E to [EPA–HQ–OPP–2012–0262; FRL–9388–9] diisocyanate, 2-oxepanone, 2,2’- read as follows: oxybis[ethanol] and polymethylene Topramezone; Pesticide Tolerances § 721.10692 Fluorinated alkyl dianiline polyphenylene isocyanate (generic). (generic). AGENCY: Environmental Protection (a) Chemical substance and (a) Chemical substance and Agency (EPA). significant new uses subject to reporting. significant new uses subject to reporting. ACTION: Final rule. (1) The chemical substance identified (1) The chemical substance identified generically as benzenedicarboxylic acid, generically as fluorinated alkyl dianiline SUMMARY: This regulation establishes polymer with substituted alkanediol, (PMN P–13–288) is subject to reporting tolerances for residues of topramezone dodecanedioic acid, 1,2-ethanediol, under this section for the significant in or on multiple commodities which alkanedioic acid, alkanediol,.alpha.- new uses described in paragraph (a)(2) are identified and discussed later in this hydro-.omega.- of this section. document. BASF Corporation requested hydroxypoly[oxyalkanediyl], 1,3- (2) The significant new uses are: these tolerances under the Federal Food, isobenzofurandione, methylene (i) Industrial, commercial, and Drug, and Cosmetic Act (FFDCA). diphenyl diisocyanate, 2-oxepanone, consumer activities. Requirements as 2,2’-oxybis[ethanol] and polymethylene DATES: This regulation is effective specified in § 721.80(g). August 7, 2013. Objections and requests polyphenylene isocyanate (PMN P–13– (ii) [Reserved] 232) is subject to reporting under this (b) Specific requirements. The for hearings must be received on or section for the significant new uses provisions of subpart A of this part before October 7, 2013, and must be described in paragraph (a)(2) of this apply to this section except as modified filed in accordance with the instructions section. by this paragraph. provided in 40 CFR Part 178 (see also (2) The significant new uses are: (1) Recordkeeping. Recordkeeping Unit I.C. of the SUPPLEMENTARY (i) Industrial, commercial, and requirements as specified in § 721.125 INFORMATION). consumer activities. Requirements as (a), (b), (c), and (i) are applicable to ADDRESSES: The docket for this action, specified in § 721.80 (o) and (y)(1). manufacturers and processors of this identified by docket identification (ID) (ii) [Reserved] substance. number EPA–HQ–OPP–2012–0262, is (b) Specific requirements. The (2) Limitations or revocation of available at http://www.regulations.gov provisions of subpart A of this part certain notification requirements. The or at the Office of Pesticide Programs apply to this section except as modified provisions of § 721.185 apply to this Regulatory Public Docket (OPP Docket) by this paragraph. section. in the Environmental Protection Agency (1) Recordkeeping. Recordkeeping ■ 26. Add § 721.10693 to subpart E to Docket Center (EPA/DC), EPA West requirements as specified in § 721.125 read as follows: Bldg., Rm. 3334, 1301 Constitution Ave. (a), (b), (c), and (i) are applicable to NW., Washington, DC 20460–0001. The manufacturers and processors of this § 721.10693 Diphenylmethane diisocyanate polymer with alkanoic diacid Public Reading Room is open from 8:30 substance. a.m. to 4:30 p.m., Monday through (2) Limitations or revocation of and alkanediol (generic). Friday, excluding legal holidays. The certain notification requirements. The (a) Chemical substance and telephone number for the Public provisions of § 721.185 apply to this significant new uses subject to reporting. Reading Room is (202) 566–1744, and section. (1) The chemical substance identified the telephone number for the OPP ■ generically as diphenylmethane 24. Add § 721.10691 to subpart E to Docket is (703) 305–5805. Please review read as follows: diisocyanate polymer with alkanoic diacid and alkanediol (PMN P–13–338) the visitor instructions and additional § 721.10691 Fatty acid amide (generic). is subject to reporting under this section information about the docket available (a) Chemical substance and for the significant new uses described in at http://www.epa.gov/dockets. significant new uses subject to reporting. paragraph (a)(2) of this section. FOR FURTHER INFORMATION CONTACT: Lois (1) The chemical substance identified (2) The significant new uses are: Rossi, Registration Division (7505P), generically as fatty acid amide (PMN P– (i) Industrial, commercial, and Office of Pesticide Programs, 13–267) is subject to reporting under consumer activities. Requirements as Environmental Protection Agency, 1200 this section for the significant new uses specified in § 721.80 (o) and (y)(1). Pennsylvania Ave. NW., Washington, described in paragraph (a)(2) of this (ii) [Reserved] DC 20460–0001; telephone number: section. (b) Specific requirements. The (703) 305–7090; email address: (2) The significant new uses are: provisions of subpart A of this part [email protected]. apply to this section except as modified (i) Release to water. Requirements as SUPPLEMENTARY INFORMATION: specified in § 721.90 (a)(4), (b)(4), and by this paragraph. (c)(4) (N=1). (1) Recordkeeping. Recordkeeping I. General Information (ii) [Reserved] requirements as specified in § 721.125 A. Does this action apply to me? (b) Specific requirements. The (a), (b), (c), and (i) are applicable to provisions of subpart A of this part manufacturers and processors of this You may be potentially affected by apply to this section except as modified substance. this action if you are an agricultural by this paragraph. (2) Limitations or revocation of producer, food manufacturer, or (1) Recordkeeping. Recordkeeping certain notification requirements. The pesticide manufacturer. The following requirements as specified in § 721.125 provisions of § 721.185 apply to this list of North American Industrial (a), (b), (c), and (k) are applicable to section. Classification System (NAICS) codes is manufacturers and processors of this [FR Doc. 2013–18982 Filed 8–6–13; 8:45 am] not intended to be exhaustive, but rather substance. BILLING CODE 6560–50–P provides a guide to help readers

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determine whether this document delivery of boxed information, please result to infants and children from applies to them. Potentially affected follow the instructions at http:// aggregate exposure to the pesticide entities may include: www.epa.gov/dockets/contacts.htm. chemical residue. . . .’’ • Crop production (NAICS code 111). Additional instructions on commenting Consistent with FFDCA section • Animal production (NAICS code or visiting the docket, along with more 408(b)(2)(D), and the factors specified in 112). FFDCA section 408(b)(2)(D), EPA has • information about dockets generally, is Food manufacturing (NAICS code available at http://www.epa.gov/ reviewed the available scientific data 311). dockets. and other relevant information in • Pesticide manufacturing (NAICS support of this action. EPA has code 32532). II. Summary of Petitioned-For sufficient data to assess the hazards of Tolerance B. How can I get electronic access to and to make a determination on other related information? In the Federal Register of May 23, aggregate exposure for topramezone 2012 (77 FR 30481) (FRL–9347–8), EPA including exposure resulting from the You may access a frequently updated issued a document pursuant to FFDCA tolerances established by this action. electronic version of EPA’s tolerance section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA’s assessment of exposures and risks regulations at 40 CFR Part 180 through announcing the filing of a pesticide associated with topramezone follows. the Government Printing Office’s e-CFR petition (PP 2F7997) by BASF A. Toxicological Profile site at http://www.ecfr.gov/cgi-bin/text- Corporation, 26 Davis Drive, P.O. Box idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 13528, Research Triangle Park, NC EPA has evaluated the available _ 40tab 02.tpl. 27709. The petition requested that 40 toxicity data and considered its validity, CFR 180.612 be amended by completeness, and reliability as well as C. How can I file an objection or hearing the relationship of the results of the request? establishing tolerances for residues of the herbicide topramezone ([3-(4,5- studies to human risk. EPA has also Under FFDCA section 408(g), 21 dihydro-3-isoxazolyl)-2-methyl-4- considered available information U.S.C. 346a, any person may file an (methylsulfonyl)phenyl](5-hydroxy-1- concerning the variability of the objection to any aspect of this regulation methyl-1H-pyrazol-4-yl)methanone), in sensitivities of major identifiable and may also request a hearing on those or on fish and shellfish at 0.05 parts per subgroups of consumers, including objections. You must file your objection million (ppm). That document infants and children. Topramezone is a or request a hearing on this regulation referenced a summary of the petition member of the class of herbicides in accordance with the instructions prepared by BASF Corporation, the known as HPPD inhibitors. Inhibition of provided in 40 CFR Part 178. To ensure registrant, which is available in the the enzyme 4-hydroxyphenylpyruvate proper receipt by EPA, you must docket, http://www.regulations.gov. dioxygenase (HPPD) results in identify docket ID number EPA–HQ– There were no comments received in decreased carotenoid synthesis and OPP–2012–0262 in the subject line on response to the notice of filing. ultimately bleaching of target plants. In the first page of your submission. All Based upon review of the data mammals, HPPD is involved in the objections and requests for a hearing supporting the petition, EPA has revised catabolism of the amino acid tyrosine, must be in writing, and must be the proposed commodity definitions and its inhibition causes blood levels of received by the Hearing Clerk on or and established tolerances for livestock tyrosine to rise; a condition known as before October 7, 2013. Addresses for meat by-products, which are needed as tyrosinemia. Some of the toxicities mail and hand delivery of objections a result of the increased livestock resulting from tyrosinemia in laboratory and hearing requests are provided in 40 dietary burden associated with the animals include ocular, developmental, CFR 178.25(b). proposed use for topramezone. The liver, and kidney effects. Topramezone In addition to filing an objection or reasons for these changes are explained exhibits a mammalian toxicity profile hearing request with the Hearing Clerk in Unit IV.C. that is consistent with HPPD inhibition. as described in 40 CFR Part 178, please The primary target organs affected submit a copy of the filing (excluding III. Aggregate Risk Assessment and following oral administration of any Confidential Business Information Determination of Safety topramezone in animal toxicity studies (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(i) of FFDCA were the eyes, thyroid, pancreas, and Information not marked confidential allows EPA to establish a tolerance (the liver. The most sensitive species was the pursuant to 40 CFR Part 2 may be legal limit for a pesticide chemical rat, and in rats and dogs, males were disclosed publicly by EPA without prior residue in or on a food) only if EPA more sensitive than females. The effects notice. Submit the non-CBI copy of your determines that the tolerance is ‘‘safe.’’ on the eyes in chronic toxicity studies objection or hearing request, identified Section 408(b)(2)(A)(ii) of FFDCA consisted of pannus (vascularization) by docket ID number EPA–HQ–OPP– defines ‘‘safe’’ to mean that ‘‘there is a and keratitis (cloudiness) of the cornea 2012–0262, by one of the following reasonable certainty that no harm will in both sexes. Hypertrophy and methods: result from aggregate exposure to the hyperplasia of the thyroid, hypertrophy • Federal eRulemaking Portal: http:// pesticide chemical residue, including and focal necrosis in the liver, and www.regulations.gov. Follow the online all anticipated dietary exposures and all degeneration of the pancreas were instructions for submitting comments. other exposures for which there is among the histopathology findings Do not submit electronically any reliable information.’’ This includes reported across different subchronic and information you consider to be CBI or exposure through drinking water and in chronic studies in rats and dogs. Results other information whose disclosure is residential settings, but does not include of chronic toxicity studies in dogs, mice, restricted by statute. occupational exposure. Section and rats also suggest decrements in • Mail: OPP Docket, Environmental 408(b)(2)(C) of FFDCA requires EPA to body weights, body-weight gains, and Protection Agency Docket Center (EPA/ give special consideration to exposure food utilization (dogs only). DC), (28221T), 1200 Pennsylvania Ave. of infants and children to the pesticide There was evidence for increased NW., Washington, DC 20460–0001. chemical residue in establishing a susceptibility following in utero • Hand Delivery: To make special tolerance and to ‘‘ensure that there is a exposure to topramezone in rats and arrangements for hand delivery or reasonable certainty that no harm will rabbits. In rabbits, fetal abnormalities

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including supernumerary thoracic included neurobehavioral and B. Toxicological Points of Departure/ vertebrae and supernumerary 13th rib neuropathological changes. Offspring Levels of Concern were observed in the presence of neurobehavioral effects consisted of a maternal toxicity in six of eight decreased auditory startle reflex at Once a pesticide’s toxicological developmental toxicity studies postnatal day 24 in both sexes (20–30%) profile is determined, EPA identifies conducted in two different strains. In and at postnatal day 60 for males (55%). toxicological points of departure (POD) rats, developmental effects consisting of There were also mild decreases in and levels of concern to use in skeletal variations occurred in the offspring absolute brain weights and evaluating the risk posed by human presence of maternal toxicity. Increased neuropathological effects involving exposure to the pesticide. For hazards maternal serum levels of tyrosine were decreased brain morphometric that have a threshold below which there reported in several developmental measurements (e.g., hippocampus, and is no appreciable risk, the toxicological toxicity studies (several in rabbits and parietal cortex). POD is used as the basis for derivation one in mice), consistent with the Topramezone is classified as ‘‘not of reference values for risk assessment. proposed mode of action for likely to be carcinogenic to humans at PODs are developed based on a careful topramezone involving HPPD doses that do not alter rat thyroid analysis of the doses in each hormone homeostasis.’’ EPA has inhibition. In the rat 2-generation toxicological study to determine the determined that the thyroid tumors arise reproductive toxicity study, there was dose at which no adverse effects are no evidence of increased pre- or post- through a non-linear mode of action, observed (the NOAEL) and the lowest natal susceptibility; offspring effects and the chronic reference dose (cRfD) is occurred in the presence of maternal expected to be protective of alterations dose at which adverse effects of concern effects. The offspring effects consisted of in hormone homeostasis that may result are identified (the LOAEL). Uncertainty/ decreased pup body weight/body- in thyroid tumor formation. safety factors are used in conjunction with the POD to calculate a safe weight gain in F2 (both sexes) and Mutagenicity studies conducted on increased time to preputial separation technical topramezone and its major exposure level—generally referred to as (F1 males). Maternal effects were metabolites did not demonstrate any a population-adjusted dose (PAD) or a consistent with HPPD inhibition mutagenic potential. reference dose (RfD)—and a safe margin (decreased body weights, decreased Specific information on the studies of exposure (MOE). For non-threshold body-weight gains, increased thyroid received and the nature of the adverse risks, the Agency assumes that any and kidney weights, and microscopic effects caused by topramezone as well amount of exposure will lead to some findings in the eyes, kidneys, and as the no-observed-adverse-effect-level degree of risk. Thus, the Agency thyroid). No reproductive effects were (NOAEL) and the lowest-observed- estimates risk in terms of the probability reported. adverse-effect-level (LOAEL) from the of an occurrence of the adverse effect Topramezone did not show any toxicity studies can be found at http:// expected in a lifetime. For more evidence of neurotoxicity in the acute www.regulations.gov in document information on the general principles (ACN) or subchronic (SCN) ‘‘Topramezone: Human-Health Risk EPA uses in risk characterization and a Assessment for (1) New Uses in Non- neurotoxicity studies, but in a rat complete description of the risk developmental neurotoxicity (DNT) Crop Aquatic Sites and (2) Increased assessment process, see http:// study, where dosing with topramezone Maximum Application Rate for www.epa.gov/pesticides/factsheets/ took place during the prenatal as well as Currently Registered Terrestrial Uses in postnatal time periods, there was the Maintenance of Bare Grounds riskassess.htm. evidence for increased qualitative (Roadsides, Utility and Railroad Rights- A summary of the toxicological susceptibility. In the maternal animals, of-Ways, Industrial Sites, and Tank endpoints for topramezone used for toxicity was limited to corneal opacity, Farms),’’ pages 36–39 in docket ID human risk assessment is shown in the whereas effects in the offspring number EPA–HQ–OPP–2012–0262. Table of this unit.

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOPRAMEZONE FOR USE IN HUMAN HEALTH RISK ASSESSMENT

Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment

Acute Dietary (General popu- LOAEL = 8 mg/kg UF = 100X (for inter- Developmental Neurotoxicity Study in Rats. lation including infants and bw. and intra-species Offspring LOAEL = 8 mg/kg bw based on decreased maximum children). extrapolation). auditory startle reflex response, decreased brain weights, FQPA SF = 10X and changes in brain morphology. aRfD = 0.008 mg/kg bw aPAD = 0.008 mg/kg bw

Acute Dietary (Females 13–49 NOAEL = 0.5 mg/kg/ UF = 100X (for inter- Developmental Toxicity Study in Rabbits. years old). day. and intra-species Developmental LOAEL = 5 mg/kg/day based on alterations in extrapolation). skeletal ossification sites and increased number of pairs of FQPA SF = 1X ribs. aRfD = 0.005 mg/kg/ day aPAD = 0.005 mg/ kg/day

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SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOPRAMEZONE FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued

Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment

Chronic Dietary (All popu- NOAEL= 0.4 mg/kg/ UF = 100X (for inter- Chronic toxicity/Carcinogenicity Study in Rats. lations). day. and intra-species LOAEL = 3.6 mg/kg/day based on increased incidences of cor- extrapolation). neal opacity, decreased body weight and body-weight gains FQPA SF = 1X in males and histopathological evaluations in the eyes, thy- cRfD = 0.004 mg/kg/ roid and pancreas of both sexes. day cPAD = 0.004 mg/ kg/day.

Incidental Oral (Short- and In- NOAEL = 0.4 mg/kg/ Residential LOC for Two-Generation Reproduction Study in Rats. termediate-Term). day. MOE = 100. Offspring LOAEL = 4.2 mg/kg/day based decreases in body weights and body-weight gains in the F2 generation offspring and increased time to preputial separation in the F1 male offspring.

Short- and Intermediate-Term, Oral NOAEL = 0.4 Residential LOC for Two-Generation Reproduction Study in Rats. Dermal. mg/kg/day. MOE = 100. Parental LOAEL = 4.2 mg/kg/day based on decreased body (DAF = 2.6%) weight, body-weight gain in males, increased thyroid and kidney weights of both sexes, and microscopic findings in eyes, kidney and thyroid of both sexes.

Short- and Intermediate-Term Oral NOAEL= 0.4 Residential LOC for Two Generation Reproduction Study in Rats. Inhalation. mg/kg/day (inhala- MOE = 100. Parental LOAEL = 4.2 mg/kg/day based on decreased body tion absorption = weight, body-weight gain in males, increased thyroid and kid- 100%). ney weights of both sexes, and microscopic findings in eyes, kidney and thyroid of both sexes.

Cancer (Oral, dermal, inhala- In accordance with the 2005 EPA Guidelines for Carcinogen Risk assessment, topramezone was classified as tion). ‘‘not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.’’ EPA has determined that the thyroid tumors arise through a non-linear mode of action and that the NOAEL (0.4 mg/kg/ day) for deriving the cRfD will be protective of thyroid hormone alterations and thyroid tumor formation. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.

C. Exposure Assessment percent crop treated (PCT), Dietary 2. Dietary exposure from drinking 1. Dietary exposure from food and Exposure Evaluation Model (DEEM) water. The highest drinking water feed uses. In evaluating dietary 7.81 default processing factors, and concentrations are expected to result exposure to topramezone, EPA tolerance-level residues. from the direct aquatic applications. considered exposure under the ii. Chronic exposure. In conducting Estimates of drinking water exposure petitioned-for tolerances as well as all the chronic dietary exposure assessment levels were based on label instructions existing topramezone tolerances in 40 EPA used the same food consumption (i.e., proposed application rates, CFR 180.612. EPA assessed dietary data and assumptions of tolerance-level duration, and water concentration of exposures from topramezone in food as residues, 100 PCT and DEEM 7.81 direct aquatic applications at potable follows: default processing factors. surface water intakes). For acute and i. Acute exposure. Quantitative acute iii. Cancer. Based on the data chronic dietary risk assessment, the dietary exposure and risk assessments summarized in Unit III.A., EPA has water concentration value of 45 parts are performed for a food-use pesticide, concluded that topramezone does not per billion (ppb) was used to assess the if a toxicological study has indicated the pose a cancer risk to humans at levels contribution to drinking water. possibility of an effect of concern that do not alter rat thyroid hormone 3. From non-dietary exposure. The occurring as a result of a 1-day or single homeostasis, and doses at or below the term ‘‘residential exposure’’ is used in exposure. Such effects were identified cRfD are not expected to alter thyroid this document to refer to non- for topramezone. homeostasis. Therefore, a dietary occupational, non-dietary exposure In estimating acute dietary exposure exposure assessment beyond the (e.g., for lawn and garden pest control, for both the general U.S. population chronic assessment for the purpose of indoor pest control, termiticides, and (including infants and children) and for assessing cancer risk is unnecessary. flea and tick control on pets). females 13–49 years of age, EPA used iv. Anticipated residue and PCT Topramezone is currently registered for food consumption information from the information. EPA did not use turf and golf course uses that could U.S. Department of Agriculture’s anticipated residue or PCT information result in residential exposures. National Health and Nutrition in the dietary assessment for Topramezone is also proposed for use in Examination Survey, What We Eat in topramezone. Tolerance-level residues direct aquatic applications that could America, (NHANES/WWEIA). As to and 100 PCT were assumed for all food result in exposure during recreational residue levels in food, EPA assumed 100 commodities. swimming activities. EPA assessed

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residential exposure using the following mice and humans have a highly In six of eight rabbit studies, there assumptions: For adults, short-term effective metabolic process for handling was evidence for increased qualitative aggregate assessment considered the excess tyrosine and are unlikely to susceptibility. In the does, maternal post-application exposure resulting achieve the levels necessary to produce toxicity was characterized as decreases from the physical activities on turf. For ocular opacities. In fact, HPPD in body weight, body weight gain, and children, short-term aggregate inhibitors (e.g. nitisinone) are used as an food consumption, all in the presence of assessment considered combined effective therapeutic agent to treat increased serum levels of tyrosine. In dermal and incidental oral (hand-to- human patients suffering from rare the fetuses, developmental toxicity was mouth) post-application exposures to genetic diseases of tyrosine catabolism. manifested as increased incidences of children 1 < 2 years old resulting from The human experience indicates that a visceral findings (i.e., absent kidney and the registered turf use. These post- therapeutic dose (1 mg/kg/day dose) has ureter) and/or multiple skeletal application exposure estimates from the an excellent safety record in infants, variations (i.e., delayed ossification, turf use are protective of post- children, and adults and that serious supernumerary 13th rib and/or 27th application exposure for older children adverse health outcomes have not been presacral vertebrae). In two studies, more likely to engage in recreational observed in a population followed for skeletal variations were observed at high swimming activities. Further approximately a decade. Rarely, ocular doses in the absence of any maternal information regarding EPA standard effects are seen in patients with high toxicity. assumptions and generic inputs for plasma tyrosine levels; however, these In the 2-generation reproduction residential exposures may be found at effects are transient and can be readily study with rats, there was no evidence http://www.epa.gov/pesticides/trac/ reversed upon adherence to a restricted of increased susceptibility. Offspring science/trac6a05.pdf. protein diet. This indicates that HPPD toxicity was characterized as decreased 4. Cumulative effects from substances inhibitor in it of itself cannot easily pup weight and weight gain in F2 male with a common mechanism of toxicity. overwhelm the tyrosine-clearance and female pups and increased time to Section 408(b)(2)(D)(v) of FFDCA mechanism in humans. preputial separation in the F1 males. requires that, when considering whether Therefore, exposure to environmental These effects were observed in the to establish, modify, or revoke a residues of HPPD-inhibiting herbicides presence of parental/systemic toxicity tolerance, the Agency consider are unlikely to result in the high blood that included: Decreased body weight, ‘‘available information’’ concerning the levels of tyrosine and ocular toxicity in decreased body-weight gain in males, cumulative effects of a particular humans due to an efficient metabolic increased thyroid and kidney weights of pesticide’s residues and ‘‘other both sexes, and microscopic findings in process to handle excess tyrosine. EPA substances that have a common the eyes, kidney, and thyroid of both has therefore not conducted cumulative mechanism of toxicity.’’ sexes. Topramezone belongs to a class of risk assessment with other HPPD In the developmental neurotoxicity herbicides that inhibit the liver enzyme inhibitors for purposes of this (DNT) study, there was evidence for HPPD, which is involved in the assessment of topramezone for aquatic qualitative susceptibility. In the catabolism (metabolic breakdown) of uses. maternal animals, toxicity was limited tyrosine (an amino acid derived from D. Safety Factor for Infants and to corneal opacity whereas effects in the proteins in the diet). Inhibition of HPPD Children offspring manifested as: can result in elevated tyrosine levels in Neurobehavioral changes (decreased the blood, a condition known as 1. In general. Section 408(b)(2)(C) of auditory startle reflex), decreases in tyrosinemia. HPPD-inhibiting herbicides FFDCA provides that EPA shall apply absolute brain weight, and decreases in have been found to cause a number of an additional tenfold (10X) margin of brain morphometric measurements (e.g., toxicities in laboratory animal studies safety for infants and children in the hippocampus, and parietal cortex). including ocular, developmental, liver, case of threshold effects to account for 3. Conclusion. While EPA is retaining and kidney effects. Of these toxicities, prenatal and postnatal toxicity and the the 10X FQPA safety factor for the acute the ocular effect (corneal opacity) is completeness of the database on toxicity dietary risk assessment for the U.S. highly correlated with the elevated and exposure unless EPA determines general population including infants blood tyrosine levels. In fact, rats dosed based on reliable data that a different and children, EPA has determined that with tyrosine alone show ocular margin of safety will be safe for infants reliable data show the safety of infants opacities similar to those seen with and children. This additional margin of and children would be adequately HPPD inhibitors. Although the other safety is commonly referred to as the protected if the FQPA SF were reduced toxicities may be associated with FQPA SF. In applying this provision, to 1X for the acute dietary risk chemically induced tyrosinemia, other EPA either retains the default value of assessment for females of child-bearing mechanisms may also be involved. 10X, or uses a different additional safety age (i.e., 13–49 years old), the chronic There are marked differences among factor when reliable data available to dietary risk assessment for the U.S. species in the ocular toxicity associated EPA support the choice of a different general population, and all non-dietary with HPPD inhibition. For example, factor. exposure scenarios. That decision is treatments with HPPD inhibitor 2. Prenatal and postnatal sensitivity. based on the following findings: herbicides result in ocular effects in the In the prenatal developmental toxicity i. The toxicity database for rat, but not the mouse or monkey. The study with rats, there was evidence for topramezone is complete, except for an explanation of this species-specific increased qualitative, but not immunotoxicity study. A database response is related to the species quantitative, susceptibility in the uncertainty factor (UFDB) is not required differences in the clearance of tyrosine. offspring. Qualitative susceptibility was for the lack of an immunotoxicity study Some species (such as the mouse and demonstrated by the occurrence of since the PODs used for overall risk monkey) have a metabolic pathway that decreased fetal body weight and assessments are based on effects seen in exists to remove tyrosine from the increased incidences of skeletal target organs (e.g., eyes, thyroid, and blood. This pathway involves a liver variations in the presence of decreased liver) consistent with the actions of this enzyme called tyrosine body weight gain in the maternal chemical as an HPPD inhibitor. An aminotransferase (TAT). Unlike rats, animals. immunotoxicity study is not likely to

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yield a lower POD and the preliminary E. Aggregate Risks and Determination of is a MOE of 100 or below, these MOEs results of the retrospective analyses Safety are not of concern. provide strong support for not retaining 4. Intermediate-term risk. EPA determines whether acute and the UFDB as no immunotoxicity study Intermediate-term aggregate exposure available thus far has provided sensitive chronic dietary pesticide exposures are takes into account intermediate-term endpoints for use in deriving points of safe by comparing aggregate exposure residential exposure plus chronic departure. estimates to the acute PAD (aPAD) and exposure to food and water (considered ii. There is some indication that chronic PAD (cPAD). For linear cancer to be a background exposure level). topramezone is a neurotoxic chemical risks, EPA calculates the lifetime Topramezone is currently registered for for developing animals. While there was probability of acquiring cancer given the turf uses that could result in no evidence of neurotoxicity or estimated aggregate exposure. Short-, intermediate-term residential exposure, neuropathology to the adult nervous intermediate-, and chronic-term risks and the Agency has determined that it system following a single oral are evaluated by comparing the is appropriate to aggregate chronic administration to rats at the limit dose estimated aggregate food, water, and exposure through food and water with in the ACN study or following repeated residential exposure to the appropriate intermediate-term residential exposures dietary administration to rats in the SCN PODs to ensure that an adequate MOE to topramezone for children that are 1– study or in the maternal animals of the exists. 2 years old that may ingest soil on DNT study, there were neurobehavioral 1. Acute risk. Acute aggregate risk is treated turf. as well as neuropathological effects made up only of dietary sources; Using the exposure assumptions observed in the offspring of the DNT therefore, the acute exposure estimates described in this unit for intermediate- study as described above. provided in the acute dietary exposure term exposures, EPA has concluded that The LOAEL of 8 mg/kg/day of the analysis represent acute aggregate the combined intermediate-term food, DNT study is based on decreased exposures. EPA has concluded that water, and residential exposures result auditory startle reflex, decreases in acute exposure to topramezone from in an aggregate MOE of 270. Because brain weight, and brain morphometric food and drinking water will utilize EPA’s level of concern for topramezone parameters at the lowest dose tested. A 98% of the aPAD for the most highly is a MOE of 100 or below, this MOE is NOAEL was not established. exposed population subgroup (all not of concern. Nevertheless, the LOAEL (8 mg/kg/day) infants <1 year old) and 50% of the 5. Aggregate cancer risk for U.S. was employed as the point of departure aPAD for females 13–49 years of age. population. As noted in Unit III.C.1.iii., in assessing the risk for the general U.S. The acute dietary assessment did not EPA has concluded that topramezone population, including infants and result in exposure estimates above does not pose a cancer risk of concern children, since the offspring were EPA’s level of concern. at exposure levels that do not alter exposed to topramezone both in utero 2. Chronic risk: Using the exposure thyroid hormone homeostasis. The and during the lactation period. The assumptions described in this unit for chronic aggregate assessment, which 10X FQPA safety factor is retained as a chronic exposure, EPA has concluded utilized a cRfD that is protective of UFL (i.e., use of a LOAEL to extrapolate that chronic exposure to topramezone those effects did not indicate a chronic a NOAEL.) from food and water will utilize 62% of risk above the Agency’s level of iii. As discussed in Unit III.D.2., there the cPAD for all infants (<1 year old), concern; therefore, topramezone is not is evidence that topramezone results in the population group receiving the expected to pose a cancer risk to increased susceptibility in the prenatal greatest exposure. Based on the humans. developmental studies in rats and explanation in Unit III.C.3., regarding 6. Determination of safety. Based on rabbits. But the degree of concern for the residential use patterns, chronic these risk assessments, EPA concludes effects seen in those studies is low residential exposure to residues of that there is a reasonable certainty that because there were clear NOAELs for topramezone is not expected. the offspring effects and EPA selected no harm will result to the general points of departure that are protective of 3. Short-term risk. Short-term population, or to infants and children those effects. As explained in Unit aggregate exposure takes into account from aggregate exposure to topramezone III.D.3.ii., EPA is retaining the 10X short-term residential exposure plus residues. FQPA safety factor for the lack of a chronic exposure to food and water IV. Other Considerations NOAEL in the DNT study and believes (considered to be a background that doing so will be protective of exposure level). Topramezone is A. Analytical Enforcement Methodology infants and children. currently registered for residential turf Adequate enforcement methodology iv. There are no residual uncertainties uses that could result in short-term (BASF method D0104) is available to in the exposure database. The dietary residential exposure, and the Agency enforce the tolerance expression. The and residential exposure analyses are has determined that it is appropriate to method may be requested from: Chief, conservative in nature. The dietary aggregate chronic exposure through food Analytical Chemistry Branch, exposure assessment uses tolerance- and water with short-term residential Environmental Science Center, 701 level residues and assumes 100 PCT. exposures to topramezone. Mapes Rd., Ft. Meade, MD 20755–5350; EPA used similarly conservative Using the exposure assumptions telephone number: (410) 305–2905; assumptions to assess post-application described in this unit for short-term email address: exposure to children/adults. The exposures, EPA has concluded the [email protected]. residential exposure assessment uses combined short-term food, water, and chemical-specific turf transferable residential exposures result in aggregate B. International Residue Limits residue data and the 2012 Residential MOEs of 220 for the general U.S. In making its tolerance decisions, EPA Standard Operating Procedures (SOPs) population and 120 for children 1–2 seeks to harmonize U.S. tolerances with and is considered health-protective. years old (a subgroup predicted to have international standards whenever These assessments will not the highest dietary burden as well as the possible, consistent with U.S. food underestimate the exposure and risks highest residential exposure. Because safety standards and agricultural posed by topramezone. EPA’s level of concern for topramezone practices. EPA considers the

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international maximum residue limits tolerances are being established for various levels of government or between (MRLs) established by the Codex cattle, goat, horse, and sheep meat the Federal Government and Indian Alimentarius Commission (Codex), as byproducts at 0.80 ppm; hog meat tribes. Thus, the Agency has determined required by FFDCA section 408(b)(4). byproducts at 0.40 ppm and poultry that Executive Order 13132, entitled The Codex Alimentarius is a joint meat byproducts at 0.02 ppm. ‘‘Federalism’’ (64 FR 43255, August 10, United Nations Food and Agriculture Compliance with the following 1999) and Executive Order 13175, Organization/World Health tolerance levels is to be determined by entitled ‘‘Consultation and Coordination Organization food standards program, measuring only topramezone ([3-(4,5- with Indian Tribal Governments’’ (65 FR and it is recognized as an international dihydro-3-isoxazolyl)-2-methyl-4- 67249, November 9, 2000) do not apply food safety standards-setting (methylsulfonyl)phenyl](5-hydroxy-1- to this final rule. In addition, this final organization in trade agreements to methyl-1H-pyrazol-4-yl)methanone) in rule does not impose any enforceable which the United States is a party. EPA or on the commodities. duty or contain any unfunded mandate may establish a tolerance that is VI. Statutory and Executive Order as described under Title II of the different from a Codex MRL; however, Reviews Unfunded Mandates Reform Act of 1995 FFDCA section 408(b)(4) requires that (UMRA) (2 U.S.C. 1501 et seq.). EPA explain the reasons for departing This final rule establishes tolerances This action does not involve any from the Codex level. There are no under FFDCA section 408(d) in technical standards that would require Codex maximum residue limits (MRLs) response to a petition submitted to the Agency consideration of voluntary in/on fish/shellfish. Agency. The Office of Management and consensus standards pursuant to section Budget (OMB) has exempted these types 12(d) of the National Technology C. Revisions to Petitioned-For of actions from review under Executive Tolerances Transfer and Advancement Act of 1995 Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note). The proposed tolerance definition, Planning and Review’’ (58 FR 51735, ‘‘fish’’ is being revised to ‘‘fish- October 4, 1993). Because this final rule VII. Congressional Review Act freshwater finfish’’ and ‘‘fish-saltwater has been exempted from review under Pursuant to the Congressional Review finfish.’’ The proposed tolerance Executive Order 12866, this final rule is Act (5 U.S.C. 801 et seq.), EPA will definition, ‘‘shellfish’’ is being revised not subject to Executive Order 13211, submit a report containing this rule and to ‘‘fish-shellfish, crustacean’’ and ‘‘fish- entitled ‘‘Actions Concerning other required information to the U.S. shellfish, mollusk.’’ EPA is also Regulations That Significantly Affect Senate, the U.S. House of establishing meat byproduct tolerances Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller for cattle, goat, horse, sheep (0.80 ppm), FR 28355, May 22, 2001) or Executive General of the United States prior to hog (0.40 ppm), and poultry (0.02 ppm) Order 13045, entitled ‘‘Protection of publication of the rule in the Federal as a result of the additional dietary Children from Environmental Health Register. This action is not a ‘‘major burden resulting from the consumption Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). of treated water by livestock since April 23, 1997). This final rule does not consumption of treated water by contain any information collections List of Subjects in 40 CFR Part 180 livestock is not restricted on the subject to OMB approval under the Environmental protection, proposed labeling for aquatic uses. With Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, the establishment of these tolerances, U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides the currently established kidney (cattle, any special considerations under and pests, Reporting and recordkeeping goat, horse, and sheep) and liver (cattle, Executive Order 12898, entitled requirements. ‘‘Federal Actions to Address goat, horse, and sheep) tolerances are Dated: July 29, 2013. being removed as it is now general Environmental Justice in Minority Lois Rossi, policy to establish meat byproduct Populations and Low-Income tolerances rather than separate liver and Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of Pesticide Programs. kidney tolerances (Chemistry Science 1994). Advisory Council (ChemSAC); Since tolerances and exemptions that Therefore, 40 CFR chapter I is min_494.12-Jan-2011). are established on the basis of a petition amended as follows: Finally, EPA has revised the tolerance under FFDCA section 408(d), such as expression to clarify that, as provided in the tolerance in this final rule, do not PART 180—[AMENDED] FFDCA section 408(a)(3), the tolerance require the issuance of a proposed rule, ■ 1. The authority citation for part 180 covers metabolites and degradates of the requirements of the Regulatory continues to read as follows: topramezone not specifically Flexibility Act (RFA) (5 U.S.C. 601 et mentioned; and that compliance with seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371. the specified tolerance levels is to be This final rule directly regulates ■ 2. Section 180.612 is revised to read determined by measuring only the growers, food processors, food handlers, as follows: specific compounds mentioned in the and food retailers, not States or tribes, tolerance expression. nor does this action alter the § 180.612 Topramezone; tolerances for relationships or distribution of power residues. V. Conclusion and responsibilities established by (a) General. Tolerances are Therefore, tolerances are established Congress in the preemption provisions established for residues of the herbicide for residues of topramezone, including of FFDCA section 408(n)(4). As such, topramezone, including its metabolites its metabolites and degradates, in or on the Agency has determined that this and degradates, in or on the following fish-freshwater, finfish; fish-saltwater, action will not have a substantial direct commodities. Compliance with the finfish; fish-shellfish, crustacean; and effect on States or tribal governments, following tolerance levels is to be fish-shellfish, mollusk at 0.05 ppm. To on the relationship between the national determined by measuring only account for additional dietary burden to government and the States or tribal topramezone ([3-(4,5-dihydro-3- livestock from residues in drinking governments, or on the distribution of isoxazolyl)-2-methyl-4- water for the proposed aquatic use, power and responsibilities among the (methylsulfonyl)phenyl](5-hydroxy-1-

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methyl-1H-pyrazol-4-yl)methanone) in Atmospheric Administration (NOAA), approximately 73% of the estimated or on the following commodities: Commerce. overfishing limit proxy of 192,000 lb— ACTION: Final specifications; correcting is associated with a 26 percent chance Parts per amendment. of overfishing. National Standard 1 Commodity million provides that the probability that SUMMARY: This document makes a Cattle, meat byproducts ...... 0.80 overfishing will occur cannot exceed 50 Corn, field, forage ...... 0.05 technical correction to the final 2013 percent, and should be a lower value. Corn, field, grain ...... 0.01 annual catch limit specifications for Accordingly, based on the analyses Corn, field, stover ...... 0.05 western Pacific fisheries that were contained in the environmental Corn, pop, grain ...... 0.01 published in the Federal Register on assessment, NMFS determined that Corn, pop, stover ...... 0.05 March 13, 2013. establishing the catch limit at this level Corn, sweet, forage ...... 0.05 DATES: Effective August 7, 2013 and is Corn, sweet, kernel plus cob would have no significant effect on the with husks removed ...... 0.01 applicable beginning April 12, 2013. quality of the human environment. FOR FURTHER INFORMATION CONTACT: Corn, sweet, stover ...... 0.05 NMFS did not receive public Fish-freshwater finfish ...... 0.05 Jarad Makaiau, Sustainable Fisheries, Fish-saltwater finfish ...... 0.05 NMFS Pacific Islands Region, 808–944– comments on the catch limit for non- Fish-shellfish, crustacean ...... 0.05 2108. Deep 7 bottomfish. The corrected catch Fish-shellfish, mollusk ...... 0.05 limit of 140,000 lb is only 3.5% lower SUPPLEMENTARY INFORMATION: At its Goat, meat byproducts ...... 0.80 than the published limit that contained 155th meeting held from October 29 Hog, meat byproducts ...... 0.40 the error. The non-Deep 7 bottomfish through November 1, 2012, the Western Horse, meat byproducts ...... 0.80 fishery is not subject to in-season Poultry, meat byproducts ...... 0.02 Pacific Fishery Management Council Sheep, meat byproducts ...... 0.80 (Council) recommended annual catch closure or other in-season accountability limits for western Pacific fisheries for measures upon attainment of the annual (b) Section 18 emergency exemptions. the 2013 fishing year, including an catch limit. Accordingly, in the unlikely [Reserved] annual catch limit of 140,000 lb for the event that the annual catch limit is (c) Tolerances with regional Hawaii non-Deep 7 bottomfish. reached, the Council and NMFS would registrations. [Reserved] NMFS published the proposed 2013 address any overage in the subsequent (d) Indirect or inadvertent residues. specifications and request for public fishing year. For these reasons, NMFS [Reserved] comments in the Federal Register on does not anticipate that fishermen will [FR Doc. 2013–18975 Filed 8–6–13; 8:45 am] January 31, 2013 (78 FR 6798). NMFS be adversely affected by the correction. BILLING CODE 6560–50–P published the final specifications in the Correction Federal Register on March 13, 2013 (78 FR 15885). Table 4 in each of those Accordingly, in the final DEPARTMENT OF COMMERCE documents contained a typographical specifications published on March 13, error. The limit for Hawaii non-Deep 7 2013 (78 FR 15885), on page 15887, in National Oceanic and Atmospheric bottomfish was inadvertently described Table 4—Hawaii, the entry for Non- Administration as 145,000 lb, rather than the 140,000 lb Deep 7 Bottomfish is revised to read recommended by the Council. This 140,000 lb (63,503 kg). 50 CFR Part 665 notice corrects the error. Dated: August 1, 2013. [Docket No. 121107617–3628–03] NMFS assessed the potential environmental impacts of specifying an Alan D. Risenhoover, RIN 0648–XC351 annual catch limit of 140,000 lb for Director, Office of Sustainable Fisheries, Western Pacific Fisheries; 2013 Annual Hawaii non-Deep 7 bottomfish for the performing the functions and duties of the 2013 fishing year. Consistent with Deputy Assistant Administrator for Catch Limits and Accountability Regulatory Programs, National Marine Measures; Correcting Amendment National Standard 1 of the Magnuson- Stevens Fishery Conservation and Fisheries Service. AGENCY: National Marine Fisheries Management Act, NMFS estimated that [FR Doc. 2013–19069 Filed 8–6–13; 8:45 am] Service (NMFS), National Oceanic and a catch limit of 140,000 lb—which is BILLING CODE 3510–22–P

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Proposed Rules Federal Register Vol. 78, No. 152

Wednesday, August 7, 2013

This section of the FEDERAL REGISTER • Email comments to: ADAMS) is provided the first time that contains notices to the public of the proposed [email protected]. If you a document is referenced. issuance of rules and regulations. The do not receive an automatic email reply • NRC’s PDR: You may examine and purpose of these notices is to give interested confirming receipt, then contact us at purchase copies of public documents at persons an opportunity to participate in the 301–415–1677. the NRC’s PDR, Room O1–F21, One rule making prior to the adoption of the final • White Flint North, 11555 Rockville rules. Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301– Pike, Rockville, Maryland 20852. 415–1101. B. Submitting Comments NUCLEAR REGULATORY • Mail comments to: Secretary, U.S. Please include Docket ID NRC–2011– COMMISSION Nuclear Regulatory Commission, Washington, DC 20555–0001, ATTN: 0268 in the subject line of your 10 CFR Part 95 Rulemakings and Adjudications Staff. comment submission, in order to ensure • Hand deliver comments to: 11555 that the NRC is able to make your [NRC–2011–0268] comment submission available to the Rockville Pike, Rockville, Maryland public in this docket. 20852, between 7:30 a.m. and 4:15 p.m. RIN 3150–AJ07 The NRC cautions you not to include (Eastern Time) Federal workdays; identifying or contact information in Facility Security Clearance and telephone: 301–415–1677. comment submissions that you do not Safeguarding of National Security For additional direction on accessing want to be publicly disclosed in your Information and Restricted Data information and submitting comments, comment submission. The NRC will see ‘‘Accessing Information and AGENCY: post all comment submissions at Nuclear Regulatory Submitting Comments’’ in the Commission. http://www.regulations.gov as well as SUPPLEMENTARY INFORMATION section of ACTION: Proposed rule. enter the comment submissions into this document. ADAMS, and the NRC does not SUMMARY: The U.S. Nuclear Regulatory FOR FURTHER INFORMATION CONTACT: routinely edit comment submissions to Commission (NRC) is proposing to Daniel W. Lenehan, Office of the remove identifying or contact update its regulations to standardize the General Counsel, U.S. Nuclear information. frequency of required security education Regulatory Commission, Washington, If you are requesting or aggregating training for employees of NRC licensees DC 20555–0001; telephone: 301–415– comments from other persons for possessing security clearances so that 3501, email: [email protected]. submission to the NRC, then you should such training will be conducted SUPPLEMENTARY INFORMATION: inform those persons not to include annually consistent with the objectives identifying or contact information that I. Accessing Information and they do not want to be publicly of Executive Order 13526, Classified Submitting Comments National Security Information. The rule disclosed in their comment submission. would allow licensees flexibility in A. Accessing Information Your request should state that the NRC does not routinely edit comment determining the means and methods for Please refer to Docket ID NRC–2011– providing this training. This action submissions to remove such information 0268 when contacting the NRC about before making the comment would establish uniformity in the the availability of information for this frequency of licensee security education submissions available to the public or proposed rule. You may access entering the comment into ADAMS. and training programs and enhances the information related to this proposed protection of classified information. rulemaking, which the NRC possesses II. Procedural Background. DATES: Submit comments by September and is publicly available, by any of the Because the NRC considers this action 6, 2013. Comments received after this following methods: to be non-controversial, the NRC is date will be considered if it is practical • Federal Rulemaking Web site: Go to publishing this proposed rule to do so, but the NRC is able to ensure http://www.regulations.gov and search concurrently as a direct final rule in the only that comments received on or for Docket ID NRC–2011–0268. Rules and Regulations section of this before this date will be considered. • NRC’s Agencywide Documents issue of the Federal Register. Adequate ADDRESSES: You may submit comments Access and Management System protection of public health and safety by any of the following methods (unless (ADAMS): You may access publicly continues to be ensured. The direct final this document describes a different available documents online in the NRC rule will become effective on October method for submitting comments on a Library at http://www.nrc.gov/reading- 21, 2013 However, if the NRC receives specific subject): rm/adams.html. To begin the search, significant adverse comments on this • Federal Rulemaking Web site: Go to select ‘‘ADAMS Public Documents’’ and proposed rule by September 6, 2013, http://www.regulations.gov and search then select ‘‘Begin Web-based ADAMS then the NRC will publish a document for Docket ID NRC–2011–0268. Address Search.’’ For problems with ADAMS, that withdraws the direct final rule. If questions about NRC dockets to Carol please contact the NRC’s Public the direct final rule is withdrawn, the Gallagher; telephone: 301–287–3422; Document Room (PDR) reference staff at NRC will address the comments email: [email protected]. For 1–800–397–4209, 301–415–4737, or by received in response to these proposed technical questions, please contact the email to [email protected]. The revisions in a subsequent final rule. individual listed in the FOR FURTHER ADAMS accession number for each Absent significant modifications to the INFORMATION CONTACT section of this document referenced in this document proposed revisions requiring proposed rule. (if that document is available in republication, the NRC will not initiate

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a second comment period on this action ■ 2. Revise § 95.33 to read as follows: submit a report to the CSA. The SF–312 in the event the direct final rule is must be signed and dated by the withdrawn. § 95.33 Security education. employee and witnessed. The A significant adverse comment is a All cleared employees must be employee’s and witness’ signatures comment where the commenter provided with security training and must bear the same date. explains why the rule would be briefings commensurate with their (e) Access to Classified Information. inappropriate, including challenges to involvement with classified Employees may have access to classified the rule’s underlying premise or information. The facility official(s) information only if: approach, or would be ineffective or responsible for the program shall (1) A favorable determination of unacceptable without a change. A determine the means and methods for eligibility for access has been made with comment is adverse and significant if: providing security education and respect to such employee by the CSA; (1) The comment opposes the rule and training. A licensee or other entity (2) The employee has signed an provides a reason sufficient to require a subject to part 95 may obtain defensive approved non-disclosure agreement; substantive response in a notice-and- security, threat awareness, and other and comment process. For example, a education and training information and (3) The employee has a need-to-know substantive response is required when: material from their Cognoscent Security the information. (A) The comment causes the NRC to Agency (CSA) or other appropriate (f) Initial Security Briefings. Initial reevaluate (or reconsider) its position or sources. training shall be provided to every conduct additional analysis; (a) Facility Security Officer Training. employee who has met the standards for (B) The comment raises an issue Licensees or other entities subject to access to classified information in serious enough to warrant a substantive part 95 are responsible for ensuring that accordance with paragraph (e) of this response to clarify or complete the the Facility Security Officer, and other section before the employee is granted record; or personnel performing security duties, access to classified information. The (C) The comment raises a relevant complete security training deemed initial training shall include the issue that was not previously addressed appropriate by the CSA. Training following topics: or considered by the NRC. requirements must be based on the (1) A Threat Awareness Briefing; (2) The comment proposes a change facility’s involvement with classified (2) A Defensive Security Briefing; or an addition to the rule and it is information and may include a Facility (3) An overview of the security apparent that the rule would be Security Officer Orientation Course and, classification system; ineffective or unacceptable without for Facility Security Officers at facilities (4) Employee reporting obligations incorporation of the change or addition. with safeguarding capability, a Facility and requirements; and (3) The comment causes the NRC to Security Officer Program Management (5) Security procedures and duties make a change (other than editorial) to Course. Training, if required, should be applicable to the employee’s job. the rule. completed within 1 year of appointment (g) Refresher Briefings. The licensee or For procedural information, see the to the position of Facility Security other entities subject to part 95 shall direct final rule published in the Rules Officer. conduct refresher briefings for all and Regulations section of this issue of (b) Government-Provided Briefings. cleared employees at least annually. As the Federal Register. The CSA is responsible for providing a minimum, the refresher briefing must initial security briefings to the Facility reinforce the information provided List of Subjects in 10 CFR Part 95 Security Officer, and for ensuring that during the initial briefing and inform Classified information, Criminal other briefings required for special employees of appropriate changes in penalties, Reporting and recordkeeping categories of information are provided. security regulations. This requirement requirements, and Security measures. (c) Temporary Help Suppliers. A may be satisfied by use of audio/video For the reasons set forth in the temporary help supplier, or other materials and/or by issuing written preamble and under the authority of the contractor who employs cleared materials to cleared employees. Atomic Energy Act of 1954, as amended; individuals solely for dispatch (h) Persons who apply derivative the Energy Reorganization Act of 1974, elsewhere, is responsible for ensuring classification markings shall receive as amended; and 5 U.S.C. 553; the NRC that required briefings are provided to training specific to the proper is proposing to adopt the following their cleared personnel. The temporary application of the derivative amendments to 10 CFR part 95. help supplier or the using licensee’s, classification principles of Executive certificate holder’s, or other person’s Order 13526, Classified National PART 95—FACILITY SECURITY facility may conduct these briefings. Security Information (75 FR 707; CLEARANCE AND SAFEGUARDING (d) Classified Information January 5, 2010), before derivatively OF NATIONAL SECURITY Nondisclosure Agreement (SF–312). The classifying information and at least once INFORMATION AND RESTRICTED SF–312 is an agreement between the every 2 years thereafter. DATA United States and an individual who is (i) Debriefings. Licensee and other cleared for access to classified facilities shall debrief cleared ■ 1. The authority citation for part 95 information. An employee issued an employees at the time of termination of continues to read as follows: initial access authorization must, in employment (discharge, resignation, or Authority: Atomic Energy Act Secs. 145, accordance with the requirements of retirement); when an employee’s access 161, 223, 234 (42 U.S.C. 2165, 2201, 2273, § 25.23 of this chapter, execute an SF– authorization is terminated, suspended, 2282); Energy Reorganization Act sec. 201 (42 312 before being granted access to or revoked; and upon termination of the U.S.C.5841); Government Paperwork classified information. The Facility Facility Clearance. Elimination Act sec. 1704 (44 U.S.C. 3504 Security Officer shall forward the (j) Records reflecting an individual’s note); E.O. 10865, as amended, 3 CFR 1959– 1963 Comp., p. 398 (50 U.S.C. 401, note); executed SF–312 to the CSA for initial and refresher security E.O. 12829, 3 CFR, 1993 Comp., p. 570; EO retention. If the employee refuses to orientations and security termination 13526, 3 CFR 2010 Comp., pp. 298–327; E.O. execute the SF–312, the licensee or must be maintained for 3 years after 12968, 3 CFR, 1995 Comp., p. 391; E.O. other facility shall deny the employee termination of the individual’s access 13526, 3 CFR, 2010 Comp., p. 298. access to classified information and authorization.

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Dated at Rockville, Maryland, this 23rd day aeronautical, economic, environmental, The Proposal of July, 2013. and energy-related aspects of the For the Nuclear Regulatory Commission. The FAA is considering an proposal. amendment to Title 14, Code of Federal R. William Borchardt, Communications should identify both Regulations (14 CFR) part 71 to amend Executive Director for Operations. docket numbers (FAA Docket No. FAA– Class E airspace extending upward from [FR Doc. 2013–18944 Filed 8–6–13; 8:45 am] 2013–0513; Airspace Docket No. 13– 700 feet above the surface within a 13.4- BILLING CODE 7590–01–P ASO–13) and be submitted in triplicate mile radius to support new Standard to the Docket Management System (see Instrument Approach Procedures ADDRESSES section for address and developed at New Tazewell Municipal DEPARTMENT OF TRANSPORTATION phone number). You may also submit Airport, Tazewell, TN. Airspace comments through the Internet at reconfiguration is necessary due to the Federal Aviation Administration http://www.regulations.gov. development of the RNAV (GPS) RWY Persons wishing the FAA to 7 approach and for continued safety and 14 CFR Part 71 acknowledge receipt of their comments management of IFR operations at the [Docket No. FAA–2013–0513; Airspace on this action must submit with those airport. Docket No. 13–ASO–13] comments a self-addressed stamped Class E airspace designations are postcard on which the following published in Paragraph 6005 of FAA Proposed Amendment of Class E statement is made: ‘‘Comments to Order 7400.9W, dated August 8, 2012, Airspace; Tazewell, TN Docket No. FAA–2013–0513; Airspace and effective September 15, 2012, which AGENCY: Federal Aviation Docket No. 13–ASO–13.’’ The postcard is incorporated by reference in 14 CFR Administration (FAA), DOT. will be date/time stamped and returned 71.1. The Class E airspace designation to the commenter. listed in this document will be ACTION: Notice of proposed rulemaking published subsequently in the Order. (NPRM). All communications received before the specified closing date for comments The FAA has determined that this SUMMARY: This action proposes to will be considered before taking action proposed regulation only involves an amend Class E Airspace at Tazewell, on the proposed rule. The proposal established body of technical TN, as new Standard Instrument contained in this notice may be changed regulations for which frequent and Approach Procedures have been in light of the comments received. A routine amendments are necessary to developed at New Tazewell Municipal report summarizing each substantive keep them operationally current. It, Airport. This action would enhance the public contact with FAA personnel therefore, (1) Is not a ‘‘significant safety and airspace management of concerned with this rulemaking will be regulatory action’’ under Executive Instrument Flight Rules (IFR) operations filed in the docket. Order 12866; (2) is not a ‘‘significant at the airport. rule’’ under DOT Regulatory Policies Availability of NPRMs and Procedures (44 FR 11034; February DATES: Comments must be received on 26, 1979); and (3) does not warrant or before September 23, 2013. An electronic copy of this document preparation of a Regulatory Evaluation may be downloaded from and ADDRESSES: Send comments on this rule as the anticipated impact is so minimal. comments submitted through http:// to: U.S. Department of Transportation, Since this is a routine matter that will www.regulations.gov. Recently Docket Operations, West Building only affect air traffic procedures and air published rulemaking documents can Ground Floor, Room W12–140, 1200 navigation, it is certified that this also be accessed through the FAA’s Web New Jersey, SE., Washington, DC proposed rule, when promulgated, page at http://www.faa.gov/ 20590–0001; Telephone: 1–800–647– would not have a significant economic airports_airtraffic/air_traffic/ 5527; Fax: 202–493–2251. You must impact on a substantial number of small publications/airspace_amendments/. identify the Docket Number FAA–2013– entities under the criteria of the 0513; Airspace Docket No. 13–ASO–13, You may review the public docket Regulatory Flexibility Act. at the beginning of your comments. You containing the proposal, any comments The FAA’s authority to issue rules may also submit and review received received, and any final disposition in regarding aviation safety is found in comments through the Internet at person in the Dockets Office (see the Title 49 of the United States Code. http://www.regulations.gov. ADDRESSES section for address and Subtitle I, Section 106 describes the FOR FURTHER INFORMATION CONTACT: John phone number) between 9:00 a.m. and authority of the FAA Administrator. Fornito, Operations Support Group, 5:00 p.m., Monday through Friday, Subtitle VII, Aviation Programs, Eastern Service Center, Federal Aviation except Federal Holidays. An informal describes in more detail the scope of the Administration, P.O. Box 20636, docket may also be examined between agency’s authority. This proposed Atlanta, Georgia 30320; telephone (404) 8:00 a.m. and 4:30 p.m., Monday rulemaking is promulgated under the 305–6364. through Friday, except Federal Holidays authority described in Subtitle VII, Part, SUPPLEMENTARY INFORMATION: at the office of the Eastern Service A, Subpart I, Section 40103. Under that Center, Federal Aviation section, the FAA is charged with Comments Invited Administration, room 350, 1701 prescribing regulations to assign the use Interested persons are invited to Columbia Avenue, College Park, Georgia of airspace necessary to ensure the comment on this rule by submitting 30337. safety of aircraft and the efficient use of such written data, views, or arguments, Persons interested in being placed on airspace. This proposed regulation is as they may desire. Comments that a mailing list for future NPRM’s should within the scope of that authority as it provide the factual basis supporting the contact the FAA’s Office of Rulemaking, would amend Class E airspace at New views and suggestions presented are (202) 267–9677, to request a copy of Tazewell Municipal Airport, Tazewell, particularly helpful in developing Advisory circular No. 11–2A, Notice of TN. reasoned regulatory decisions on the Proposed Rulemaking distribution This proposal would be subject to an proposal. Comments are specifically System, which describes the application environmental analysis in accordance invited on the overall regulatory, procedure. with FAA Order 1050.1E,

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‘‘Environmental Impacts: Policies and SUMMARY: This action proposes to All communications received before Procedures’’ prior to any FAA final amend Class E Airspace at Danville the specified closing date for comments regulatory action. Regional Airport, Danville, VA, to will be considered before taking action accommodate new landing and on the proposed rule. The proposal Lists of Subjects in 14 CFR Part 71 departure procedures, and by removing contained in this notice may be changed Airspace, Incorporation by reference, the operating hours established by a in light of the comments received. A Navigation (Air). Notice to Airmen (NOTAM). This action report summarizing each substantive The Proposed Amendment: would enhance the safety and airspace public contact with FAA personnel management of Instrument Flight Rules concerned with this rulemaking will be In consideration of the foregoing, the (IFR) operations at the airport. This filed in the docket. Federal Aviation Administration action also would update the airport’s Availability of NPRMs proposes to amend 14 CFR Part 71 as geographic coordinates. follows: An electronic copy of this document DATES: Comments must be received on or before September 23, 2013. may be downloaded from and PART 71—DESIGNATION OF CLASS A, comments submitted through http:// ADDRESSES: B, C, D, AND E AIRSPACE AREAS; AIR Send comments on this rule www.regulations.gov. Recently TRAFFIC SERVICE ROUTES; AND to: U.S. Department of Transportation, published rulemaking documents can REPORTING POINTS Docket Operations, West Building also be accessed through the FAA’s Web Ground Floor, Room W12–140, 1200 ■ page at http://www.faa.gov/ 1. The authority citation for Part 71 New Jersey SE., Washington, DC 20590– _ _ continues to read as follows: airports airtraffic/air traffic/ 0001; Telephone: 1–800–647–5527; Fax: publications/airspace_amendments/. Authority: 49 U.S.C. 106(g); 40103, 40113, 202–493–2251. You must identify the You may review the public docket 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– Docket Number FAA–2013–0469; containing the proposal, any comments 1963 Comp., p. 389. Airspace Docket No. 13–AEA–9, at the received, and any final disposition in § 71.1 [Amended] beginning of your comments. You may person in the Dockets Office (see the also submit and review received ■ 2. The incorporation by reference in ADDRESSES section for address and comments through the Internet at http:// 14 CFR 71.1 of Federal Aviation phone number) between 9:00 a.m. and www.regulations.gov. Administration Order 7400.9W, 5:00 p.m., Monday through Friday, Airspace Designations and Reporting FOR FURTHER INFORMATION CONTACT: John except Federal Holidays. An informal Points, dated August 8, 2012, effective Fornito, Operations Support Group, docket may also be examined between September 15, 2012, is amended as Eastern Service Center, Federal Aviation 8:30 a.m. and 5:00 p.m. Monday through follows: Administration, P. O. Box 20636, Friday, except Federal Holidays at the Atlanta, Georgia 30320; telephone (404) office of the Eastern Service Center, Paragraph 6005. Class E Airspace Areas 305–6364. Federal Aviation Administration, room Extending Upward from 700 feet or More SUPPLEMENTARY INFORMATION: 350, 1701 Columbia Avenue, College Above the Surface of the Earth. Park, Georgia 30337. Comments Invited * * * * * Persons interested in being placed on Interested persons are invited to ASO TN E5 Tazewell, TN [Amended] a mailing list for future NPRM’s should comment on this rule by submitting contact the FAA’s Office of Rulemaking, New Tazewell Municipal Airport, TN such written data, views, or arguments, (lat. 36°24’32’’ N., long. 83°33’26’’ W.) (202) 267–9677, to request a copy of as they may desire. Comments that Advisory circular No. 11–2A, Notice of That airspace extending upward from 700 provide the factual basis supporting the feet above the surface within a 13.4-mile Proposed Rulemaking distribution radius of New Tazewell Municipal Airport. views and suggestions presented are System, which describes the application particularly helpful in developing procedure. Issued in College Park, Georgia, on July 31, reasoned regulatory decisions on the 2013. proposal. Comments are specifically The Proposal Paul Lore, invited on the overall regulatory, The FAA is considering an Acting Manager, Operations Support Group, aeronautical, economic, environmental, amendment to Title 14, Code of Federal Eastern Service Center, Air Traffic and energy-related aspects of the Regulations (14 CFR) part 71 to amend Organization. proposal. the Class E surface area airspace to [FR Doc. 2013–19090 Filed 8–6–13; 8:45 am] Communications should identify both within a 5-mile radius of the airport, BILLING CODE 4910–13–P docket numbers (FAA Docket No. FAA– with a segment extending from the 5- 2013–0469; Airspace Docket No. 13– mile radius to 7 miles southwest and 7 AEA–9) and be submitted in triplicate to miles northeast of Danville Regional DEPARTMENT OF TRANSPORTATION the Docket Management System (see Airport, Danville, VA. Due to increased ADDRESSES section for address and air traffic, controlled airspace would be Federal Aviation Administration phone number). You may also submit continuous 24 hours, and no longer comments through the Internet at http:// would be effective during the specific 14 CFR Part 71 www.regulations.gov. dates and times established in advanced [Docket No. FAA–2013–0469; Airspace Persons wishing the FAA to by NOTAM. Also, the geographic Docket No.13–AEA–9] acknowledge receipt of their comments coordinates of the airport would be on this action must submit with those adjusted to coincide with the FAAs Proposed Amendment of Class E comments a self-addressed stamped aeronautical database. Airspace; Danville, VA postcard on which the following Class E airspace designations are AGENCY: Federal Aviation statement is made: ‘‘Comments to published in Paragraph 6002 of FAA Administration (FAA), DOT. Docket No. FAA–2013–0469; Airspace Order 7400.9W, dated August 8, 2012, Docket No. 13–AEA–9.’’ The postcard and effective September 15, 2012, which ACTION: Notice of proposed rulemaking will be date/time stamped and returned is incorporated by reference in 14 CFR (NPRM). to the commenter. 71.1. The Class E airspace designations

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listed in this document will be Authority: 49 U.S.C. 106(g); 40103, 40113, Docket Operations, West Building published subsequently in the Order. 40120; E.O. 10854, 24 FR9565, 3 CFR, 1959– Ground Floor, Room W12–140, 1200 1963 Comp., p. 389. The FAA has determined that this New Jersey, SE., Washington, DC proposed regulation only involves an § 71.1 [Amended] 20590–0001; Telephone: 1–800–647– established body of technical ■ 2. The incorporation by reference in 5527; Fax: 202–493–2251. You must regulations for which frequent and 14 CFR 71.1 of Federal Aviation identify the Docket Number FAA–2013– routine amendments are necessary to Administration Order 7400.9W, 0430; Airspace Docket No. 13–ASO–8, keep them operationally current. It, Airspace Designations and Reporting at the beginning of your comments. You therefore, (1) Is not a ‘‘significant Points, signed August 8, 2012, effective may also submit and review received regulatory action’’ under Executive September 15, 2012, is amended as comments through the Internet at http:// Order 12866; (2) is not a ‘‘significant follows: www.regulations.gov. rule’’ under DOT Regulatory Policies FOR FURTHER INFORMATION CONTACT: John and Procedures (44 FR 11034; February Paragraph 6002 Class E Airspace Fornito, Operations Support Group, 26, 1979); and (3) does not warrant Designated as Surface Areas Eastern Service Center, Federal Aviation preparation of a Regulatory Evaluation * * * * * Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) as the anticipated impact is so minimal. AEA VA E2 Danville, VA [Amended] Since this is a routine matter that will 305–6364. Danville Regional Airport only affect air traffic procedures and air SUPPLEMENTARY INFORMATION: (Lat. 36°34′22″ N., long. 79°20′10″ W.) navigation, it is certified that this proposed rule, when promulgated, That airspace extending upward from the Comments Invited surface within a 5-mile radius of Danville would not have a significant economic Regional Airport and within 2.4-mile each Interested persons are invited to impact on a substantial number of small side of a 208° bearing from the airport, comment on this rule by submitting entities under the criteria of the extending from the 5-mile radius to 7 miles such written data, views, or arguments, Regulatory Flexibility Act. southwest of the airport, and within 2.4-mile as they may desire. Comments that ° The FAA’s authority to issue rules each side of a 016 bearing from the airport, provide the factual basis supporting the regarding aviation safety is found in extending from the 5-mile radius to 7 miles views and suggestions presented are northeast of the airport. Title 49 of the United States Code. particularly helpful in developing reasoned regulatory decisions on the Subtitle I, Section 106 describes the Issued in College Park, Georgia, on July 31, authority of the FAA Administrator. 2013. proposal. Comments are specifically invited on the overall regulatory, Subtitle VII, Aviation Programs, Paul Lore, describes in more detail the scope of the aeronautical, economic, environmental, Acting Manager, Operations Support Group, and energy-related aspects of the agency’s authority. This proposed Eastern Service Center, Air Traffic rulemaking is promulgated under the Organization. proposal. authority described in Subtitle VII, Part, Communications should identify both [FR Doc. 2013–19077 Filed 8–6–13; 8:45 am] docket numbers (FAA Docket No. FAA– A, Subpart I, Section 40103. Under that BILLING CODE 4910–13–P section, the FAA is charged with 2013–0430; Airspace Docket No. 13– prescribing regulations to assign the use ASO–8) and be submitted in triplicate to of airspace necessary to ensure the DEPARTMENT OF TRANSPORTATION the Docket Management System (see safety of aircraft and the efficient use of ADDRESSES section for address and airspace. This proposed regulation is Federal Aviation Administration phone number). You may also submit within the scope of that authority as it comments through the Internet at http:// would amend Class E airspace at 14 CFR Part 71 www.regulations.gov. Danville Regional Airport, Danville, VA. Persons wishing the FAA to [Docket No. FAA–2013–0430; Airspace acknowledge receipt of their comments This proposal will be subject to an Docket No. 13–ASO–8] on this action must submit with those environmental analysis in accordance comments a self-addressed stamped with FAA Order 1050.1E, Proposed Establishment of Class E Airspace; Magee, MS postcard on which the following ‘‘Environmental Impacts: Policies and statement is made: ‘‘Comments to Procedures’’ prior to any FAA final AGENCY: Federal Aviation Docket No. FAA–2013–0430; Airspace regulatory action. Administration (FAA), DOT. Docket No. 13–ASO–8.’’ The postcard Lists of Subjects in 14 CFR Part 71 ACTION: Notice of proposed rulemaking will be date/time stamped and returned (NPRM). to the commenter. Airspace, Incorporation by reference, All communications received before Navigation (Air). SUMMARY: This action proposes to the specified closing date for comments establish Class E Airspace at Magee, MS, The Proposed Amendment will be considered before taking action to accommodate a new Area Navigation on the proposed rule. The proposal In consideration of the foregoing, the (RNAV) Global Positioning System contained in this notice may be changed Federal Aviation Administration (GPS) Standard Instrument Approach in light of the comments received. A proposes to amend 14 CFR Part 71 as Procedure (SIAP) serving Magee report summarizing each substantive follows: Municipal Airport. This action would public contact with FAA personnel enhance the safety and airspace concerned with this rulemaking will be PART 71—DESIGNATION OF CLASS A, management of Instrument Flight Rules filed in the docket. B, C, D, AND CLASS E AIRSPACE (IFR) operations within the National AREAS; AIR TRAFFIC SERVICE Airspace System. Availability of NPRMs ROUTES; AND REPORTING POINTS DATES: Comments must be received on An electronic copy of this document or before September 23, 2013. may be downloaded from and ■ 1. The authority citation for Part 71 ADDRESSES: Send comments on this rule comments submitted through http:// continues to read as follows: to: U. S. Department of Transportation, www.regulations.gov. Recently

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published rulemaking documents can would not have a significant economic That airspace extending upward from 700 also be accessed through the FAA’s Web impact on a substantial number of small feet above the surface within a 6.3- mile page at http://www.faa.gov/ entities under the criteria of the radius of Magee Municipal Airport. airports_airtraffic/air_traffic/ Regulatory Flexibility Act. Issued in College Park, Georgia, on July 31, _ publications/airspace amendments/. The FAA’s authority to issue rules 2013. You may review the public docket regarding aviation safety is found in Paul Lore, containing the proposal, any comments Title 49 of the United States Code. Acting Manager, Operations Support Group, received and any final disposition in Subtitle I, Section 106 describes the Eastern Service Center, Air Traffic person in the Dockets Office (see the authority of the FAA Administrator. Organization. ADDRESSES section for address and Subtitle VII, Aviation Programs, [FR Doc. 2013–19078 Filed 8–6–13; 8:45 am] phone number) between 9:00 a.m. and describes in more detail the scope of the BILLING CODE 4910–13–P 5:00 p.m., Monday through Friday, agency’s authority. This proposed except Federal Holidays. An informal rulemaking is promulgated under the docket may also be examined between authority described in Subtitle VII, Part, DEPARTMENT OF TRANSPORTATION 8:00 a.m. and 4:30 p.m., Monday A, Subpart I, Section 40103. Under that through Friday, except Federal Federal Aviation Administration section, the FAA is charged with Holidays, at the office of the Eastern prescribing regulations to assign the use Service Center, Federal Aviation 14 CFR Part 71 of airspace necessary to ensure the Administration, room 350, 1701 safety of aircraft and the efficient use of [Docket No. FAA–2013–0558; Airspace Columbia Avenue, College Park, Georgia airspace. This proposed regulation is Docket No. 13–AEA–10] 30337. Persons interested in being placed on within the scope of that authority as it would establish Class E airspace at Proposed Establishment of Class E a mailing list for future NPRMs should Airspace; McConnellsburg, PA contact the FAA’s Office of Rulemaking, Magee Municipal Airport, Magee, MS. (202) 267–9677, to request a copy of This proposal will be subject to an AGENCY: Federal Aviation Advisory circular No. 11–2A, Notice of environmental analysis in accordance Administration (FAA), DOT. Proposed Rulemaking distribution with FAA Order 1050.1E, ACTION: Notice of proposed rulemaking System, which describes the application ‘‘Environmental Impacts: Policies and (NPRM). procedure. Procedures’’ prior to any FAA final regulatory action. SUMMARY: This action proposes to The Proposal establish Class E Airspace at The FAA is considering an Lists of Subjects in 14 CFR Part 71 McConnellsburg, PA, to accommodate a amendment to Title 14, Code of Federal Airspace, Incorporation by reference, new Area Navigation (RNAV) Global Regulations (14 CFR) part 71 to establish Navigation (Air). Positioning System (GPS) special Class E airspace at Magee, MS, Standard Instrument Approach providing the controlled airspace The Proposed Amendment Procedure (SIAP) serving Fulton County required to support the new RNAV Medical Center Heliport. This action In consideration of the foregoing, the (GPS) standard instrument approach would enhance the safety and airspace Federal Aviation Administration procedures for Magee Municipal management of Instrument Flight Rules proposes to amend 14 CFR Part 71 as Airport. Controlled airspace extending (IFR) operations within the National follows: upward from 700 feet above the surface Airspace System. is required for IFR operations within a PART 71—DESIGNATION OF CLASS A, DATES: Comments must be received on 6.3-mile radius of the airport. B, C, D, AND CLASS E AIRSPACE or before September 23, 2013. Class E airspace designations are AREAS; AIR TRAFFIC SERVICE ADDRESSES: Send comments on this rule published in Paragraph 6005 of FAA ROUTES; AND REPORTING POINTS order 7400.9W, dated August 8, 2012, to: U. S. Department of Transportation, and effective September 15, 2012, which Docket Operations, West Building ■ 1. The authority citation for Part 71 is incorporated by reference in 14 CFR Ground Floor, Room W12–140, 1200 continues to read as follows: 71.1. The Class E airspace designation New Jersey SE., Washington, DC 20590– listed in this document will be Authority: 49 U.S.C. 106(g); 40103, 40113, 0001; Telephone: 1–800–647–5527; Fax: published subsequently in the Order. 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 202–493–2251. You must identify the The FAA has determined that this 1963 Comp., p. 389. Docket Number FAA–2013–0558; Airspace Docket No. 13–AEA–10, at the proposed regulation only involves an § 71.1 [Amended] established body of technical beginning of your comments. You may regulations for which frequent and ■ 2. The incorporation by reference in also submit and review received routine amendments are necessary to 14 CFR 71.1 of Federal Aviation comments through the Internet at keep them operationally current. It, Administration Order 7400.9W, http://www.regulations.gov. therefore, (1) Is not a ‘‘significant Airspace Designations and Reporting FOR FURTHER INFORMATION CONTACT: John regulatory action’’ under Executive Points, dated August 8, 2012, effective Fornito, Operations Support Group, Order 12866; (2) is not a ‘‘significant September 15, 2012, is amended as Eastern Service Center, Federal Aviation rule’’ under DOT Regulatory Policies follows: Administration, P.O. Box 20636, and Procedures (44 FR 11034; February Atlanta, Georgia 30320; telephone (404) Paragraph 6005 Class E Airspace Areas 305–6364. 26, 1979); and (3) does not warrant Extending Upward From 700 Feet or More preparation of a Regulatory Evaluation Above the Surface of the Earth. SUPPLEMENTARY INFORMATION: as the anticipated impact is so minimal. * * * * * Since this is a routine matter that will Comments Invited only affect air traffic procedures and air ASO MS E5 Magee, MS [New] Interested persons are invited to navigation, it is certified that this Magee Municipal Airport, MS comment on this rule by submitting proposed rule, when promulgated, (Lat. 31°51′41″ N., long. 89°48′10″ W.) such written data, views, or arguments,

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as they may desire. Comments that contact the FAA’s Office of Rulemaking, within the scope of that authority as it provide the factual basis supporting the (202) 267–9677, to request a copy of would establish Class E airspace at views and suggestions presented are Advisory circular No. 11–2A, Notice of Fulton County Medical Center Heliport, particularly helpful in developing Proposed Rulemaking distribution McConnellsburg, PA. reasoned regulatory decisions on the System, which describes the application This proposal will be subject to an proposal. Comments are specifically procedure. invited on the overall regulatory, environmental analysis in accordance The Proposal aeronautical, economic, environmental, with FAA Order 1050.1E, and energy-related aspects of the The FAA is considering an ‘‘Environmental Impacts: Policies and proposal. amendment to Title 14, Code of Federal Procedures’’ prior to any FAA final Communications should identify both Regulations (14 CFR) part 71 to establish regulatory action. docket numbers (FAA Docket No. FAA– Class E airspace at McConnellsburg, PA, Lists of Subjects in 14 CFR Part 71 2013–0558; Airspace Docket No. 13– providing the controlled airspace AEA–10) and be submitted in triplicate required to support the new Copter Airspace, Incorporation by reference, to the Docket Management System (see RNAV (GPS) special standard Navigation (air). ADDRESSES section for address and instrument approach procedures for phone number). You may also submit Fulton County Medical Center Heliport. The Proposed Amendment comments through the Internet at Controlled airspace extending upward http://www.regulations.gov. from 700 feet above the surface is In consideration of the foregoing, the Persons wishing the FAA to required for IFR operations within a 6- Federal Aviation Administration acknowledge receipt of their comments mile radius of the point in space proposes to amend 14 CFR part 71 as on this action must submit with those coordinates of the heliport. follows: comments a self-addressed stamped Class E airspace designations are PART 71—DESIGNATION OF CLASS A, postcard on which the following published in Paragraph 6005 of FAA statement is made: ‘‘Comments to order 7400.9W, dated August 8, 2012, B, C, D, AND CLASS E AIRSPACE Docket No. FAA–2013–0558; Airspace and effective September 15, 2012, which AREAS; AIR TRAFFIC SERVICE Docket No. 13–AEA–10.’’ The postcard is incorporated by reference in 14 CFR ROUTES; AND REPORTING POINTS will be date/time stamped and returned 71.1. The Class E airspace designation to the commenter. listed in this document will be ■ 1. The authority citation for Part 71 All communications received before published subsequently in the Order. continues to read as follows: the specified closing date for comments The FAA has determined that this Authority: 49 U.S.C. 106(g); 40103, 40113, will be considered before taking action proposed regulation only involves an 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– on the proposed rule. The proposal established body of technical 1963 Comp., p. 389. contained in this notice may be changed regulations for which frequent and in light of the comments received. A routine amendments are necessary to § 71.1 [Amended] report summarizing each substantive keep them operationally current. It, ■ public contact with FAA personnel therefore, (1) Is not a ‘‘significant 2. The incorporation by reference in concerned with this rulemaking will be regulatory action’’ under Executive 14 CFR 71.1 of Federal Aviation filed in the docket. Order 12866; (2) is not a ‘‘significant Administration Order 7400.9W, rule’’ under DOT Regulatory Policies Airspace Designations and Reporting Availability of NPRMs and Procedures (44 FR 11034; February Points, dated August 8, 2012, effective An electronic copy of this document 26, 1979); and (3) does not warrant September 15, 2012, is amended as may be downloaded from and preparation of a Regulatory Evaluation follows: comments submitted through http:// as the anticipated impact is so minimal. www.regulations.gov. Recently Since this is a routine matter that will Paragraph 6005 Class E Airspace Areas published rulemaking documents can only affect air traffic procedures and air Extending Upward From 700 Feet or More also be accessed through the FAA’s Web navigation, it is certified that this Above the Surface of the Earth. page at http://www.faa.gov/ proposed rule, when promulgated, * * * * * _ _ airports airtraffic/air traffic/ would not have a significant economic AEA PA E5 McConnellsburg, PA [New] publications/airspace_amendments/. impact on a substantial number of small Fulton County Medical Center Heliport, PA You may review the public docket entities under the criteria of the ° ′ ″ ° ′ ″ containing the proposal, any comments Regulatory Flexibility Act. (Lat. 39 56 17 N., long. 78 00 27 W.) Point in Space Coordinates received and any final disposition in The FAA’s authority to issue rules ° ′ ″ ° ′ ″ person in the Dockets Office (see the regarding aviation safety is found in (Lat. 39 55 25 N., long. 78 00 26 W.) ADDRESSES section for address and Title 49 of the United States Code. That airspace extending upward from 700 phone number) between 9:00 a.m. and Subtitle I, Section 106 describes the feet above the surface within a 6-mile radius 5:00 p.m., Monday through Friday, authority of the FAA Administrator. of the Point in Space Coordinates (lat. except Federal Holidays. An informal Subtitle VII, Aviation Programs, 39°55′25″ N., long. 78°00′26″ W.) serving docket may also be examined between describes in more detail the scope of the Fulton County Medical Center Heliport. 8:00 a.m. and 4:30 p.m., Monday agency’s authority. This proposed Issued in College Park, Georgia, on July 31, through Friday, except Federal rulemaking is promulgated under the 2013. Holidays, at the office of the Eastern authority described in Subtitle VII, Part, Service Center, Federal Aviation A, Subpart I, Section 40103. Under that Paul Lore, Administration, Room 350, 1701 section, the FAA is charged with Acting Manager, Operations Support Group, Columbia Avenue, College Park, Georgia prescribing regulations to assign the use Eastern Service Center, Air Traffic 30337. of airspace necessary to ensure the Organization. Persons interested in being placed on safety of aircraft and the efficient use of [FR Doc. 2013–19082 Filed 8–6–13; 8:45 am] a mailing list for future NPRMs should airspace. This proposed regulation is BILLING CODE 4910–13–P

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PEACE CORPS and superfluous language and ensures For the reasons set out in the the rule is consistent with current law. preamble, the Peace Corps proposes to 22 CFR Part 303 The proposed rule inserts additional amend 22 CFR part 303 as follows: RIN 0420–AA29 contact information for the filing of initial Freedom of Information Act PART 303—PROCEDURES FOR Freedom of Information Act (‘‘FOIA’’) requests; inserts additional DISCLOSURE OF INFORMATION Administration contact information for the filing of UNDER THE FREEDOM OF administrative appeals; and, adds two INFORMATION ACT AGENCY: Peace Corps. FOIA exemptions 5 U.S.C. 552(b)8, ■ ACTION: Proposed rule. Contained in or related to examination, 1. The authority citation for part 303 continues to read as follows: SUMMARY: The proposed rule updates operating, or condition reports prepared Peace Corps regulations on the Freedom by, on behalf of, or for the use of an Authority: 5 U.S.C. 552; 22 U.S.C. 2501, et seq.; E.O. 12137, 44 FR 29023, 3 CFR, 1979 of Information Act (FOIA) to implement agency responsible for the regulation or supervision of financial institutions; Comp., p. 389; E.O. 12600, 52 FR 23781, 3 guidance given by the President and the CFR, 1987 Comp., p. 235. Attorney General regarding and (b)9, Geological and geophysical ■ information and data, including maps, 2. Amend § 303.2 by revising discretionary disclosures of records or paragraph (e) to read as follows: information exempt from disclosure concerning wells. The Peace Corps under the FOIA, whenever disclosure FOIA regulations were last revised May § 303.2 Definitions. would not foreseeably harm an interest 14, 2007 (72 FR 27055). * * * * * protected by a FOIA exemption. The Request for Comments (e) OIG records means those records proposed rule is based on language used as defined generally in this section by Department of Justice in its FOIA The Peace Corps invites public which originated with or are in the regulations. Additionally, the proposed comment on all aspects of this interim possession and control of the Office of rule deletes unnecessary and final rule and will take those comments Inspector General (OIG) of the Peace superfluous language and ensures the into account before publishing a final Corps which have been compiled for rule is consistent with current law. rule. law enforcement, audit, and DATES: Comments must be received by Executive Order 12866 investigative functions and/or any other September 6, 2013. The proposed purpose authorized under the Inspector Disclosure of Information under the This regulation has been determined General Act of 1978, as amended. to be non-significant within the Freedom of Information Act 0420–AA29 * * * * * meaning of Executive Order 12866. will be effective September 6, 2013, ■ 3. Revise § 303.3 to read as follows: unless the Peace Corps receives Regulatory Flexibility Act of 1980 (5 comments that require a different U.S.C. 605(b)) § 303.3 Policy. determination. The Peace Corps will make its records This regulatory action will not have a concerning its operations, activities, and ADDRESSES: Written comments should significant adverse impact on a business available to the public be addressed to Anthony F. Marra, substantial number of small entities. consistent with the requirements of the Associate General Counsel, Office of the FOIA. As a matter of policy, the Peace General Counsel, Peace Corps, 1111 Unfunded Mandates Act of 1995 (Sec. Corps makes discretionary disclosures 20th Street NW., Washington, DC 20526. 202, Pub. L. 104–4) of records or information exempt from Comments may also be sent This regulatory action does not disclosure under the FOIA whenever electronically to the following email contain a Federal mandate that will disclosure would not foreseeably harm address: [email protected]. result in the expenditure by State, local, an interest protected by a FOIA Written comments should refer to and tribal governments, in aggregate, or exemption, but this policy does not Federal Register: Procedures for by the private sector of $100 or more in create any right enforceable in court. Disclosure of Information under the any one year. ■ 4. Amend § 303.5 by: Freedom of Information Act 0420– (a) Revising paragraphs (a), (b) AA29, and if sent electronically, should Paperwork Reduction Act of 1995 (44 introductory text, and (d) as set forth contain this reference on the subject U.S.C., Chapter 35) below; and line. This regulatory action will not impose (b) Removing paragraph (e). FOR FURTHER INFORMATION CONTACT: any additional reporting or Anne Passmore, Office of the General recordkeeping requirements under the § 303.5 Public reading room. Counsel, Policy and Program Analyst, Paperwork Reduction Act. (a) The Peace Corps maintains a 1111 20th Street NW., Washington, DC public reading room at its headquarters 20526, and 202–692–2164. Federalism (Executive Order 13132) at 1111 20th Street NW., Washington, SUPPLEMENTARY INFORMATION: The This regulatory action does not have DC 20526. This room is supervised and revisions to the Peace Corps’ FOIA Federalism implications, as set forth in is open to the public during Peace regulations would incorporate the Executive Order 13132. It will not have Corps’ regular business hours for disclosure principles contained in substantial direct effects on the States, inspecting and copying records President Obama’s January 21, 2009 on the relationship between the national described in paragraph (b) of this Memorandum regarding FOIA, the government and the States, or on the section. Attorney General’s FOIA Guidelines to distribution of power and (b) Subject to the limitation stated in Favor Disclosure and Transparency responsibilities among the various paragraph (c) of this section, the Peace dated March 19, 2009, and the Guide to levels of government. Corps makes the following records the Freedom of Information Act available in the public reading room: List of Subjects in 22 CFR Part 303 promulgated by the Department of * * * * * Justice’s Office of Information Policy. Administrative practice and (d) Electronic reading room. Records The proposed rule deletes unnecessary procedure, Freedom of information. required by the FOIA to be maintained

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and made available in the public familiar with the subject area of the (ii) Refer the responsibility for reading room created by the Peace Corps request are able, with a reasonable responding to the request for the record on or after November 1, 1996, are made amount of effort, to determine which to the other agency (but only if the available electronically on the Peace particular records are within the scope agency is subject to FOIA). Ordinarily, Corps Web site at http:// of the request. If it is determined that a the agency that originated a record will www.peacecorps.gov. request does not reasonably describe the be presumed to be best able to ■ 5. Amend § 303.8 by revising records sought, the requester shall be so determine whether to disclose it. paragraphs (a), (b), (c), and (l)(1)(iv) to informed and provided an opportunity (2) * * * read as follows: to confer with Peace Corps personnel in (ii) Whenever a request is made for a record containing information that has § 303.8 Requests for records. order to attempt to reformulate the request in a manner that will meet the been classified by another agency or (a) Except for records required by the needs of the requester and the may be appropriate for classification FOIA to be published in the Federal requirements of this paragraph. If the under Executive Order 13525 or any Register or to be made available in the Agency cannot identify the requested other executive order concerning the public reading room, the Peace Corps records after a 2 hour search, it may classification of records, the Peace will make its records promptly determine that the records were not Corps shall refer the responsibility for available, upon request, to any person in adequately described and ask the responding to the request regarding that accordance with this section, unless it is requester to provide a more specific information to the agency that classified determined that such records should be request. the information, should consider the withheld and are exempt from information for classification, or has the * * * * * mandatory disclosure under the FOIA. primary interest in the information, as (b) Requests. Requests for records (l) * * * appropriate. under this section shall be made in (1) * * * (iv) A matter of widespread and * * * * * writing via regular mail, email, ■ 8. Amend § 303.12 by revising exceptional media interest in which facsimile, online Web portal and, as paragraph (a) to read as follows: applicable, the envelope and the letter there exist possible questions about the shall be clearly marked ‘‘Freedom of Peace Corps’ or the Federal § 303.12 Appeals. Information Request.’’ All requests shall government’s integrity which affect (a) Any person whose written request be addressed to the FOIA Officer. public confidence. has been denied is entitled to appeal the Requests by letter shall use the address * * * * * denial within 20 business days by given in § 303.5(a). Requests by email ■ 6. Amend § 303.9 by adding writing to the Associate Director of the must be sent to the FOIA electronic paragraphs (e)(8) and (9) as follows: Office of Management or, in the case of mailbox, [email protected]. Request a denial of a request for OIG Records, submitted via online Web portal § 303.9 Exemptions for withholding the Inspector General, at the address (accessible on the agency Web site, records. given in 303.5(a). An appeal need not be www.peacecorps.gov), requesters shall * * * * * in any particular form, but should fill in all of the fields as required. Any (e) * * * adequately identify the denial, if request not marked and addressed as (8) Contained in or related to possible, by describing the requested specified in this paragraph will be so examination, operating, or condition record, identifying the official who marked by Peace Corps personnel as reports prepared by, on behalf of, or for issued the denial, and providing the soon as the request is properly the use of an agency responsible for the date on which the denial was issued. If identified. The request will be regulation or supervision of financial the appeal is sent via mail, the envelope forwarded immediately to the FOIA institutions; or and the letter shall be clearly marked Officer. A request improperly addressed (9) Geological and geophysical ‘‘Freedom of Information Appeal’’ and will not be deemed to have been information and data, including maps, the appeal shall be addressed to the received for purposes of the time period concerning wells. Associate Director, Office of set out in paragraph (h) of this section ■ 7. Amend § 303.10 by revising Management. Appeals by letter shall use until it has been received by the FOIA paragraphs (a), (c)(1)(i), (c)(1)(ii), and the address given in § 303.5(a). Appeals Officer. Upon receipt of an improperly (c)(2)(ii) to read as follows: are accepted via email. Appeals by addressed request, the FOIA Officer § 303.10 Responsibilities and authorities. email must be sent to the FOIA shall notify the requester of the date on electronic mailbox, which the time period began. Requests (a) Legal counsel. The General [email protected]. Appeals by letter shall be stamped ‘‘received’’ on Counsel (GC) shall furnish legal advice submitted via online Web portal the date received by the FOIA Office. to Peace Corps officials and staff as to (accessible on the agency Web site, Requests by email shall be ‘‘received’’ their obligations under this part and www.peacecorps.gov), requesters shall on the date the email arrived, if a shall take such other actions as may be fill in all of the fields as required. business day, or on the next business necessary or appropriate to assure a Appeals by online Web portal will be day. Requests by online Web portal will consistent and equitable application of entered automatically in the FOIA be entered automatically in the FOIA the provisions of this part by and within tracking system. Persons submitting an tracking system. Requests sent via mail the Peace Corps. The OIG Legal Counsel appeal may utilize the online Web or email will be entered manually in the will coordinate with GC, as appropriate portal for purpose of checking status of FOIA tracking system. Requesters may and necessary, when furnishing legal requests (open/closed) for requests from utilize the online Web portal for advice to the OIG FOIA Officer and all sources. Inspector General. purpose of checking status of requests * * * * * (open/closed) for requests from all * * * * * ■ 9. Amend § 303.13 by revising sources. (c) * * * paragraph (b) to read as follows: (c) A request must reasonably (1) * * * describe the records requested so that (i) Consult with the other agency § 303.13 Fees. employees of the Peace Corps who are before responding to the request; or * * * * *

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(b) For each commercial use request, (1) Federal eRulemaking Portal: having been received by the Coast fees will be limited to reasonable http://www.regulations.gov. Guard when it is received at the Docket standard charges for document search, (2) Fax: 202–493–2251. Management Facility. We recommend review, and duplication. (3) Mail: Docket Management Facility that you include your name and a * * * * * (M–30), U.S. Department of mailing address, an email address, or a ■ 10. Amend § 303.14 by revising Transportation, West Building Ground telephone number in the body of your paragraphs (a)(5)(i) and (ii) to read as Floor, Room W12–140, 1200 New Jersey document so that we can contact you if follows: Avenue SE., Washington, DC 20590– we have questions regarding your 0001. submission. § 303.14 Procedures for responding to a (4) Hand delivery: Same as mail To submit your comment online, go to subpoena. address above, between 9 a.m. and 5 http://www.regulations.gov, type the (a) * * * p.m., Monday through Friday, except docket number (USCG–2012–1069) in (5) * * * Federal holidays. The telephone number the ‘‘SEARCH’’ box and click (i) Congressional requests or is 202–366–9329. ‘‘SEARCH.’’ Click on the ‘‘Submit a subpoenas for testimony or documents; To avoid duplication, please use only Comment’’ on the line associated with (ii) Employees or former employees one of these four methods. See the this rulemaking. making appearances solely in their ‘‘Public Participation and Request for If you submit your comments by mail private capacity in legal or Comments’’ portion of the or hand delivery, submit them in an administrative proceedings that do not SUPPLEMENTARY INFORMATION section unbound format, no larger than 81⁄2 by relate to the Agency (such as cases below for instructions on submitting 11 inches, suitable for copying and arising out of traffic accidents or comments. electronic filing. If you submit domestic relations). Any question FOR FURTHER INFORMATION CONTACT: If comments by mail and would like to whether the appearance relates solely to you have questions on this rule, call or know that they reached the Facility, the employee’s or former employee’s email Mr. Mark Cutter, Coast Guard please enclose a stamped, self-addressed private capacity should be referred to Sector Boston Waterways Management postcard or envelope. We will consider the Office of the General Counsel. Division, telephone 617–223–4000, all comments and material received * * * * * email [email protected]. If you during the comment period and may change the rule based on your Dated: August 1, 2013. have questions on viewing or submitting material to the docket, call Barbara comments. James Pimpedly, Hairston, Program Manager, Docket 2. Viewing Comments and Documents Chief, Administrative Services, Management. Operations, telephone 202–366–9826. [FR Doc. 2013–19050 Filed 8–6–13; 8:45 am] To view comments, as well as SUPPLEMENTARY INFORMATION: BILLING CODE 6051–01–P documents mentioned in this preamble Table of Acronyms as being available in the docket, go to http://www.regulations.gov, type the DEPARTMENT OF HOMELAND DHS Department of Homeland Security docket number (USCG–2012–1069) in SECURITY FR Federal Register the ‘‘SEARCH’’ box and click NPRM Notice of Proposed Rulemaking ‘‘SEARCH.’’ Click on Open Docket Coast Guard COTP Captain of the Port Folder on the line associated with this A. Public Participation and Request for rulemaking. You may also visit the 33 CFR Part 165 Comments Docket Management Facility in Room W12–140 on the ground floor of the [Docket No. USCG–2012–1069] We encourage you to participate in Department of Transportation West RIN 1625–AA00 this rulemaking by submitting Building, 1200 New Jersey Avenue SE., comments and related materials. All Washington, DC 20590, between 9 a.m. Safety Zones; Chelsea River, Boston comments received will be posted and 5 p.m., Monday through Friday, Inner Harbor, Boston, MA without change to http:// except Federal holidays. www.regulations.gov and will include AGENCY: Coast Guard, DHS. any personal information you have 3. Privacy Act ACTION: Notice of proposed rulemaking. provided. Anyone can search the electronic form of comments received into any of SUMMARY: The Coast Guard proposes to 1. Submitting Comments disestablish the existing Safety Zone for our dockets by the name of the If you submit a comment, please individual submitting the comment (or the Chelsea River, Boston Inner Harbor, include the docket number for this Boston, MA. Since the implementation signing the comment, if submitted on rulemaking (USCG–2012–1069), behalf of an association, business, labor of the regulation, physical changes have indicate the specific section of this occurred within the confines of the union, etc.). You may review a Privacy document to which each comment Act notice regarding our public dockets safety zone, making the provisions of applies, and provide a reason for each the safety zone no longer applicable. in the January 17, 2008, issue of the suggestion or recommendation. You Federal Register (73 FR 3316). DATES: Comments and related material may submit your comments and must be received by the Coast Guard on material online at via http:// 4. Public Meeting or before September 6, 2013. Requests www.regulations.gov, or by fax, mail, or The Coast Guard does not currently for public meetings must be received by hand delivery, but please use only one plan to hold public meetings. However, the Coast Guard on or before August 28, of these means. If you submit a a public meeting may be requested by 2013. comment online, it will be considered using one of the four methods specified ADDRESSES: You may submit comments received by the Coast Guard when you under ADDRESSES. Please explain why identified by docket number USCG– successfully transmit the comment. If you believe a public meeting would be 2012–1069 using any one of the you fax, hand deliver, or mail your beneficial. If we determine that one following methods: comment, it will be considered as would aid this rulemaking, we will hold

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one at a time and place announced by been expanded to a width of 175 feet. This proposed rule would affect the a later notice in the Federal Register. Six new permanent fixed lighted aids to following entities, some of which may navigation structures have been be small entities: vessel owners and B. Regulatory History and Information installed in the immediate area of the operators in the affected waterway. On Thursday, January 31, 2013, the bridge to best mark the new channel. The proposed rule would not have a Coast Guard published an Advance significant impact on a substantial notice of proposed rulemaking D. Comments and Discussion of number of small entities because, as (ANPRM) in the Federal Register (78 FR Proposed Rule mentioned in the Regulatory Planning 6782). The USCG received three written The three written comments received and Review section, it proposes to comments in response to this ANPRM. in the docket were all in favor of entirely remove 33 CFR 165.120 and its Also, the USCG held two public disestablishing the safety zone. Two of safety zone and thus, lessen the meetings in which verbal comments those written comments were from the restriction on vessels transiting in the were received. The minutes of these Boston Harbor Pilots Association and affected area. public meetings are available in the there was one joint comment from the If you think that your business, docket. On the whole, the written and three oil terminals up river of the safety organization, or governmental verbal comments received support the zone; Global Partners LP, Gulf Oil jurisdiction qualifies as a small entity disestablishment of 33 CFR 165.120 and Limited Partnership, and Irving Oil and that this rule would have a its safety zone. Moreover, no comment Terminals Inc. All the verbal comments significant economic impact on it, was received in favor of keeping this received in the public meetings were in please submit a comment (see safety zone. The Coast Guard considered favor of disestablishing the safety zone. ADDRESSES) explaining why you think it all comments when crafting this These comments can be seen in the qualifies and how and to what degree proposed rule. docket under meeting minutes. this rule would economically affect it. C. Basis and Purpose For all of the reasons discussed above, the Coast Guard proposes to disestablish 3. Assistance for Small Entities The legal basis for the proposed rule the safety zone contained in 33 CFR Under section 213(a) of the Small is 33 U.S.C. 1231, 1233; 46 U.S.C. 165.120, Safety Zone: Chelsea River, Business Regulatory Enforcement Chapter 701, 3306, 3703; 50 U.S.C. 191, Boston Inner Harbor, Boston, MA by Fairness Act of 1996 (Pub. L. 104–121), 195; 33 CFR 1.05–1, and 160.5; Public removing that section completely. we want to assist small entities in Law 107–295, 116 Stat. 2064; and understanding this proposed rule so E. Regulatory Analyses Department of Homeland Security that. If the rule would affect your small Delegation No. 0170.1, which We developed this proposed rule after business, organization, or governmental collectively authorize the Coast Guard considering numerous statutes and jurisdiction and you have questions to define regulatory safety zones. executive orders related to rulemaking. concerning its provisions or options for The original Chelsea Street Bridge Below we summarize our analyses compliance, please contact the person was a bascule-type bridge owned by the based on these statutes or executive listed under FOR FURTHER INFORMATION City of Boston and constructed in 1939. orders. CONTACT. The Coast Guard will not It spanned the Chelsea River providing 1. Regulatory Planning and Review retaliate against small entities that a means for vehicles to travel between question or complain about this Chelsea, MA and East Boston, MA. This proposed rule is not a significant proposed rule or any policy or action of Several petroleum-product transfer regulatory action under section 3(f) of the Coast Guard. facilities are located on the Chelsea Executive Order 12866, Regulatory River, upstream and downstream of the Planning and Review, as supplemented 4. Collection of Information Chelsea Street Bridge. Transit of tank by Executive Order 13563, and does not This proposed rule would call for no vessels through the bridge is necessary require an assessment of potential costs new collection of information under the to access the petroleum facilities and benefits under section 6(a)(3) of that Paperwork Reduction Act of 1995 (44 upstream of the bridge. The narrow, Order. The Office of Management and U.S.C. 3501–3520.). ninety-six foot horizontal span created a Budget has not reviewed it under that narrow passage through the bridge for Order. We expect the economic impact 5. Federalism larger vessels. Adding to the difficulty is of this rule to be minimal because A rule has implications for federalism the close proximity of neighboring shore removing this safety zone would lessen under Executive Order 13132, structures and, at times, vessels moored the restriction on vessels transiting this Federalism, if it has a substantial direct at the Sunoco Logistics facility area. effect on the States, on the relationship downstream of the bridge on the East between the national government and 2. Impact on Small Entities Boston side. These factors led to the the States, or on the distribution of establishment of the present safety zone The Regulatory Flexibility Act of 1980 power and responsibilities among the regulation which restricts the passage of (RFA), 5 U.S.C. 601–612, as amended, various levels of government. We have certain vessels through the Chelsea requires federal agencies to consider the analyzed this proposed rule under that Street Bridge based on vessel potential impact of regulations on small Order and determined that this rule dimensional criteria, assist tug support, entities during rulemaking. The term does not have implications for and daylight restrictions. ‘‘small entities’’ comprises small federalism. Since the implementation of the businesses, not-for-profit organizations regulations, physical changes have that are independently owned and 6. Protest Activities occurred within the confines of the operated and are not dominant in their The Coast Guard respects the First safety zone. A new vertical lift span fields, and governmental jurisdictions Amendment rights of protesters. bridge with a 175-foot vertical clearance with populations of less than 50,000. Protesters are asked to contact the and a 175-foot horizontal navigable The Coast Guard certifies under 5 U.S.C. person listed in the FOR FURTHER channel span has been constructed in 605(b) that this proposed rule will not INFORMATION CONTACT section to place of the old Chelsea Street Bridge. have a significant economic impact on coordinate protest activities so that your The federal navigational channel has a substantial number of small entities. message can be received without

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jeopardizing the safety or security of 13. Technical Standards ENVIRONMENTAL PROTECTION people, places or vessels. AGENCY This proposed rule does not use 7. Unfunded Mandates Reform Act technical standards. Therefore, we did 40 CFR Parts 52 and 81 not consider the use of voluntary The Unfunded Mandates Reform Act [EPA–R05–OAR–2012–0564; FRL–9844–2] of 1995 (2 U.S.C. 1531–1538) requires consensus standards. Federal agencies to assess the effects of 14. Environment Approval and Promulgation of Air their discretionary regulatory actions. In Quality Implementation Plans; Ohio; particular, the Act addresses actions We have analyzed this proposed rule Redesignation of the Canton-Massillon that may result in the expenditure by a under Department of Homeland Area to Attainment of the 1997 Annual State, local, or tribal government, in the Security Management Directive 023–01 and 2006 24-Hour Standards for Fine aggregate, or by the private sector of and Commandant Instruction Particulate Matter $100,000,000 (adjusted for inflation) or M16475.lD, which guide the Coast AGENCY: Environmental Protection more in any one year. Though this Guard in complying with the National Agency (EPA). proposed rule would not result in such Environmental Policy Act of 1969 ACTION: Proposed rule. an expenditure, we do discuss the (NEPA) (42 U.S.C. 4321–4370f), and effects of this rule elsewhere in this have made a preliminary determination SUMMARY: On June 26, 2012, the Ohio preamble. that this action may be one of a category Environmental Protection Agency 8. Taking of Private Property of actions that do not individually or submitted a request for EPA to cumulatively have a significant effect on redesignate the Canton-Massillon area This proposed rule would not cause a the human environment. (Stark County), Ohio, nonattainment taking of private property or otherwise area to attainment of the 1997 annual This proposed rule involves have taking implications under and 2006 24-hour standards for fine disestablishing a safety zone, so this Executive Order 12630, Governmental particulate matter (PM2.5). EPA is Actions and Interference with action may be categorically excluded, proposing to grant Ohio’s request. EPA Constitutionally Protected Property under figure 2–1, paragraph (34)(g) of is proposing to determine that the Rights. the Instruction. Canton-Massillon area attains the 1997 We seek any comments or information annual and the 2006 24-hour PM2.5 9. Civil Justice Reform that may lead to the discovery of a standard, based on the most recent three This proposed rule meets applicable significant environmental impact from years of certified air quality data. EPA standards in sections 3(a) and 3(b)(2) of this proposed rule. is proposing to approve, as revisions to Executive Order 12988, Civil Justice the Ohio state implementation plan List of Subjects (SIP), the state’s plan for maintaining Reform, to minimize litigation, the 1997 annual and 2006 24-hour PM eliminate ambiguity, and reduce 2.5 33 CFR Part 165 national ambient air quality standard burden. Harbors, Marine Safety, Navigation (NAAQS or standard) through 2025 for 10. Protection of Children From (water), Reporting and recordkeeping the area. EPA is proposing to approve Environmental Health Risks requirements, Security measures, and the 2005 and 2008 emissions inventories for the Canton-Massillon Waterways. We have analyzed this proposed rule area as meeting the comprehensive under Executive Order 13045, For the reasons discussed in the emissions inventory requirement of the Protection of Children from preamble, the Coast Guard proposes to Clean Air Act (CAA or Act). Ohio’s Environmental Health Risks and Safety amend 33 CFR Part 165 as follows: maintenance plan submission includes Risks. This rule is not an economically a motor vehicle emission budget significant rule and would not create an PART 165—REGULATED NAVIGATION (MVEB) for the mobile source environmental risk to health or risk to AREAS AND LIMITED ACCESS AREAS contribution of PM2.5 and nitrogen safety that might disproportionately oxides (NOX) to the Canton-Massillon affect children. ■ 1. The authority citation for Part 165 area for transportation conformity 11. Indian Tribal Governments continues to read as follows: purposes; EPA is proposing to approve the MVEBs for 2015 and 2025 into the Authority: 33 U.S.C. 1231; 46 U.S.C. This proposed rule does not have Ohio SIP for transportation conformity Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; tribal implications under Executive purposes. 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Order 13175, Consultation and DATES: Comments must be received on Coordination with Indian Tribal Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. or before September 6, 2013. Governments, because it would not have ADDRESSES: Submit your comments, a substantial direct effect on one or § 165.120 [Removed] identified by Docket ID No. EPA–R05– more Indian tribes, on the relationship ■ OAR–2012–0564, by one of the between the Federal Government and 2. Remove § 165.120 Safety Zone: following methods: Indian tribes, or on the distribution of Chelsea River, Boston Inner Harbor, Boston, MA. 1. www.regulations.gov: Follow the power and responsibilities between the on-line instructions for submitting Federal Government and Indian tribes. Dated: July 22, 2013. comments. 12. Energy Effects J.C. O’Connor III, 2. E-Mail: [email protected]. Captain, U.S. Coast Guard, Captain of the 3. Fax: (312) 692–2450. We have analyzed this proposed rule Port Boston. 4. Mail: Pamela Blakley, Chief, under Executive Order 13211, Actions [FR Doc. 2013–19104 Filed 8–6–13; 8:45 am] Control Strategies Section (AR–18J), Concerning Regulations That U.S. Environmental Protection Agency, Significantly Affect Energy Supply, BILLING CODE 9110–04–P 77 West Jackson Boulevard, Chicago, Distribution, or Use. Illinois 60604.

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5. Hand Delivery: Pamela Blakley, Region 5, Air and Radiation Division, 77 5. If you estimate potential costs or Chief, Control Strategies Section (AR– West Jackson Boulevard, Chicago, burdens, explain how you arrived at 18J), U.S. Environmental Protection Illinois 60604. This facility is open from your estimate in sufficient detail to Agency, 77 West Jackson Boulevard, 8:30 a.m. to 4:30 p.m., Monday through allow for it to be reproduced. Chicago, Illinois 60604. Such deliveries Friday, excluding Federal holidays. We 6. Provide specific examples to are only accepted during the Regional recommend that you telephone Carolyn illustrate your concerns, and suggest Office normal hours of operation, and Persoon, Environmental Engineer, at alternatives. special arrangements should be made (312) 353–8290 before visiting the 7. Explain your views as clearly as for deliveries of boxed information. The Region 5 office. possible, avoiding the use of profanity Regional Office official hours of FOR FURTHER INFORMATION CONTACT: or personal threats. business are Monday through Friday, Carolyn Persoon, Environmental 8. Make sure to submit your 8:30 a.m. to 4:30 p.m. excluding Federal Engineer, Control Strategies Section, Air comments by the comment period holidays. Programs Branch (AR–18J), deadline identified. Instructions: Direct your comments to Environmental Protection Agency, II. What actions is EPA proposing to Docket ID No. EPA–R05–OAR–2012– Region 5, 77 West Jackson Boulevard, take? 0564. EPA’s policy is that all comments Chicago, Illinois 60604, (312) 353–8290, EPA is proposing to take several received will be included in the public [email protected]. actions related to redesignation of the docket without change and may be SUPPLEMENTARY INFORMATION: This made available online at Canton-Massillon area to attainment for supplementary information section is the 1997 annual and 2006 24-hour PM www.regulations.gov, including any arranged as follows: 2.5 personal information provided, unless NAAQS. EPA is proposing to determine the comment includes information I. What should I consider as I prepare my that the area is attaining the NAAQS for comments for EPA? claimed to be Confidential Business PM2.5, based on quality-assured and II. What actions is EPA proposing to take? state certified ambient air monitoring Information (CBI) or other information III. What is the background for these actions? whose disclosure is restricted by statute. IV. What are the criteria for redesignation to data for 2010–2012, the most recent Do not submit information that you attainment? three years of quality-assured data for consider to be CBI or otherwise V. What is EPA’s analysis of the state’s the area. EPA is proposing to find that protected through www.regulations.gov request? Ohio meets the requirements for or email. The www.regulations.gov Web 1. Attainment redesignation of the Canton-Massillon site is an ‘‘anonymous access’’ system, 2. The Area Has Met All Applicable area to attainment of the 1997 and 2006 Requirements Under Section 110 and which means EPA will not know your 24-hour PM2.5 NAAQS under section Part D and Has a Fully Approved SIP identity or contact information unless Under Section 110(k) (Sections 107(d)(3)(E) of the CAA. you provide it in the body of your 107(d)(3)(E)(v) and 107(d)(3)(E)(ii)) Second, EPA is proposing to approve comment. If you send an email 3. The Improvement in Air Quality Is Due Ohio’s annual PM2.5 maintenance plan comment directly to EPA without going to Permanent and Enforceable for the Canton-Massillon area as a through www.regulations.gov your email Reductions in Emissions Resulting From revision to the Ohio SIP, including the address will be automatically captured Implementation of the SIP and MVEB for PM2.5 and NOX emissions for and included as part of the comment Applicable Federal Air Pollution Control the mobile source contribution of the that is placed in the public docket and Regulations and Other Permanent and Canton-Massillon area. Enforceable Reductions (Section Finally, EPA is proposing to approve made available on the Internet. If you 107(d)(3)(E)(iii)) submit an electronic comment, EPA 4. Ohio Has a Fully Approved Maintenance Ohio’s emissions inventories as recommends that you include your Plan Pursuant to Section 175A of the satisfying the requirement in section name and other contact information in CAA (Section 107(d)(3)(E)(iv)) 172(c)(3) of the CAA for a current, the body of your comment and with any 5. Adequacy of Ohio’s MVEB accurate and comprehensive emission disk or CD–ROM you submit. If EPA 6. 2005 and 2008 Comprehensive inventory. These emission inventories cannot read your comment due to Emissions Inventory include primary PM2.5, NOX and sulfur 7. Summary of Proposed Actions technical difficulties and cannot contact dioxide (SO2) inventories included in its VI. What are the effects of EPA’s proposed you for clarification, EPA may not be actions? June 26, 2012, initial submittal and 2007 able to consider your comment. VII. Statutory and Executive Order Reviews. emissions for volatile organic Electronic files should avoid the use of compounds (VOCs) and ammonia special characters, any form of I. What Should I Consider as I Prepare inventories included in a supplemental encryption, and be free of any defects or My Comments for EPA? submission to EPA on April 29, 2013. viruses. For additional instructions on When submitting comments, Therefore, EPA is proposing to grant submitting comments, go to Section I of remember to: the request from the state of Ohio to the SUPPLEMENTARY INFORMATION section 1. Identify the rulemaking by docket change the designation of Stark County of this document. number and other identifying (the Canton-Massillon area) from Docket: All documents in the docket information (subject heading, Federal nonattainment to attainment of the 1997 are listed in the www.regulations.gov Register date and page number). annual and 2006 24-hour PM2.5 NAAQS. index. Although listed in the index, 2. Follow directions—EPA may ask III. What is the background for these some information is not publicly you to respond to specific questions or actions? available, e.g., CBI or other information organize comments by referencing a whose disclosure is restricted by statute. Code of Federal Regulations (CFR) part Fine particulate pollution can be Certain other material, such as or section number. emitted directly from a source (primary copyrighted material, will be publicly 3. Explain why you agree or disagree; PM2.5) or formed secondarily through available only in hard copy. Publicly suggest alternatives and substitute chemical reactions in the atmosphere available docket materials are available language for your requested changes. involving precursor pollutants emitted either electronically in 4. Describe any assumptions and from a variety of sources. Sulfates are a www.regulations.gov or in hard copy at provide any technical information and/ type of secondary particulate formed the Environmental Protection Agency, or data that you used. from SO2 emissions from power plants

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and industrial facilities. Nitrates, (PM2.5)’’ final rule (73 FR 28321, May to the area for purposes of redesignation another common type of secondary 16, 2008). 706 F.3d 428 (D.C. Cir. 2013). under section 110 and part D of the particulate, are formed from combustion Also noted are the decisions of the CAA. emissions of NO from power plants, D.C. Circuit regarding the status of the X V. What is EPA’s analysis of the state’s mobile sources and other combustion Cross-State Air Pollution Rule (CSAPR). request? sources. In the first of the two Court decisions, The first air quality standards for the D.C. Circuit, on August 21, 2012, EPA is proposing to redesignate the Canton-Massillon area to attainment of PM2.5 were promulgated on July 18, issued EME Homer City Generation, L.P. 1997, at 62 FR 38652. EPA promulgated v. EPA, 696 F.3d 7 (D.C. Cir. 2012), the 1997 annual and 2006 24-hour PM2.5 an annual standard at a level of 15 which vacated and remanded CSAPR NAAQS and is proposing to approve micrograms per cubic meter (mg/m3) of and ordered EPA to continue Ohio’s maintenance plan for the area ambient air, based on a three year administering the Clean Air Interstate and other related SIP revisions. The bases for these actions follow. average of the annual mean PM2.5 Rule (CAIR) ‘‘pending . . . concentrations at each monitoring site. development of a valid replacement.’’ 1. Attainment In the same rulemaking, EPA EME Homer City at 38. The D.C. Circuit EPA is proposing to determine that promulgated a 24-hour PM2.5 standard at denied all petitions for rehearing on 65 mg/m3, based on a three year average January 24, 2013. On August 21, 2012, the Canton-Massillon area is attaining the 1997 annual and 2006 24-hour PM2.5 of the 98th percentile of 24-hour PM2.5 the D.C. Circuit issued a decision to concentrations at each monitoring site. vacate CSAPR. In that decision, the NAAQS based upon the most recent Court also ordered EPA to continue three years of complete, certified and On January 5, 2005, at 70 FR 944, EPA administering CAIR ‘‘pending the quality-assured data. Under EPA’s published air quality area designations promulgation of a valid replacement.’’ regulations at 40 CFR 50.7, the annual for the 1997 annual PM2.5 standard EME Homer City, 696 F.3d at 38. The primary and secondary PM2.5 standards based on air quality data for calendar D.C. Circuit denied all petitions for are met when the annual arithmetic years 2001–2003. In that rulemaking, rehearing on January 24, 2013. EPA and mean concentration, as determined in EPA designated the Canton-Massillon other parties filed petitions for certiorari accordance with 40 CFR part 50, area as nonattainment for the 1997 to the U.S. Supreme Court. On June 24, appendix N, is less than or equal to 15.0 annual PM standard. 2.5 2013, the Supreme Court granted mg/m3 at all monitoring sites in the area. On October 17, 2006, at 71 FR 61144, certiorari and agreed to review the D.C. Under EPA regulations in 40 CFR 50.13 EPA retained the annual PM2.5 standard Circuit’s decision in EME Homer City. and in accordance with 40 CFR part 50, 3 at 15 mg/m (2006 annual PM2.5 The Supreme Court’s grant of certiorari, appendix N, the 24-hour primary and standard), but revised the 24-hour by itself, does not alter the status of secondary PM2.5 standards are met when 3 standard to 35 mg/m , based again on the CAIR or CSAPR. At this time, CAIR the 98th percentile 24-hour three-year average of the annual 98th remains in place. EPA has determined concentration is less than or equal to 35 percentile of the 24-hour PM2.5 that the status of both CSAPR and CAIR mg/m3. concentrations. In response to legal do not affect the ability of the Canton- EPA has reviewed the ambient air challenges of the 2006 annual PM2.5 Massillon area to attain or maintain the quality monitoring data in the Canton- standard, the U.S. Court of Appeals for PM NAAQS, which is discussed in more Massillon area, consistent with the the District of Columbia Circuit (D.C. detail in section V.3.aii. requirements contained at 40 CFR part Circuit or Court) remanded this 50. EPA’s review focused on state standard to EPA for further IV. What are the criteria for certified data recorded in the EPA Air consideration. See American Farm redesignation to attainment? Quality System (AQS) database for the Bureau Federation and National Pork The CAA sets forth the requirements Canton-Massillon PM2.5 nonattainment Producers Council, et al. v. EPA, 559 for redesignating a nonattainment area area for 2009–2011 and for 2010–2012. F.3d 512 (D.C. Cir. 2009). On December to attainment. Specifically, section The Canton-Massillon area has two 14, 2012, EPA finalized a rule revising 107(d)(3)(E) of the CAA allows for monitors located in Stark County, Ohio. 3 the PM2.5 annual standard to 12 mg/m redesignation provided that: (1) The Preliminary calculations of design based on current scientific evidence Administrator determines that the area values for 2010–2012, the most recent regarding the protection of public has attained the applicable NAAQS three full years of data, the two monitors health. Since the Canton-Massillon area based on current air quality data; (2) the had design values of 13.0 and 11.8 mg/ is designated as nonattainment for the Administrator has fully approved an m3 for the 1997 annual standard, and 29 1997 annual and 2006 24-hour PM2.5 applicable SIP for the area under section and 26 mg/m3 for the 2006 24-hour standards, today’s proposed action 110(k) of the CAA; (3) the Administrator standard. The monitors in the Canton- addresses redesignation to attainment determines that the improvement in air Massillon area recorded complete data only for these standards. quality is due to permanent and for 2010–2012 in accordance with In this proposed redesignation, EPA enforceable emission reductions criteria set forth by EPA in 40 CFR part takes into account the January 4, 2013, resulting from implementation of the 50, appendix N, where a complete year Court ruling in Natural Resources applicable SIP, Federal air pollution of air quality data comprises four Defense Council v. EPA, in which the control regulations and other permanent calendar quarters, with each quarter D.C. Circuit remanded to EPA the ‘‘Final and enforceable emission reductions; (4) containing data with at least 75% Clean Air Fine Particle Implementation the Administrator has fully approved a capture of the scheduled sampling days. Rule’’ (72 FR 20586, April 25, 2007) and maintenance plan for the area meeting Available data are considered to be the ‘‘Implementation of the New Source the requirements of section 175A of the sufficient for comparison to the NAAQS Review (NSR) Program for Particulate CAA; and (5) the state containing the if three consecutive complete years of Matter Less than 2.5 Micrometers area has met all requirements applicable data exist.

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TABLE 1—THE 1997 ANNUAL AND 2006 24-HOUR PM2.5 DESIGN VALUES FOR THE CANTON-MASSILLON MONITORS (IN μg/m3)

Annual 24-Hour Annual 24-Hour County Site standard standard standard standard 2009–2011 2009–2011 2010–2012 2010–2012

Stark, OH1 ...... 391510017 13.4 30 13.0 29 Stark, OH ...... 391510020 11.9 28 11.8 26 1 Design values for the site 391510017 were incomplete for 2009–2011 due to one quarter in 2009, substitution analysis for 2009–2011 showed attainment for the annual standard. 2010–2012 data was complete for both standards.

EPA’s review of these monitoring data implementation plan submitted by a a particular area’s designation are the supports EPA’s determination that the state must have been adopted by the relevant measures which we may Canton-Massillon area has monitored state after reasonable public notice and consider in evaluating a redesignation attainment for the most recent three hearing, and, among other things, must: request. This approach is consistent years of data. Therefore, EPA proposes include enforceable emission with EPA’s existing policy on to determine that the Canton-Massillon limitations and other control measures, applicability of conformity and area is attaining the 1997 annual and means or techniques necessary to meet oxygenated fuels requirements for 2006 24-hour PM2.5 standards. the requirements of the CAA; provide redesignation purposes, as well as with 2. The Area Has Met All Applicable for establishment and operation of section 184 ozone transport Requirements Under Section 110 and appropriate devices, methods, systems requirements. See Reading, Part D and Has a Fully Approved SIP and procedures necessary to monitor Pennsylvania, proposed and final Under Section 110(k) (Sections ambient air quality; provide for rulemakings (61 FR 53174–53176, 107(d)(3)(E)(v) and 107(d)(3)(E)(ii)) implementation of a source permit October 10, 1996) and (62 FR 24826, program to regulate the modification May 7, 1997); Cleveland-Akron-Lorain, We believe that Ohio has met all and construction of any stationary Ohio, final rulemaking (61 FR 20458, currently applicable SIP requirements source within the areas covered by the May 7, 1996); and Tampa, Florida, final for purposes of redesignation for the plan; include provisions for the rulemaking (60 FR 62748, December 7, Canton-Massillon area under section implementation of part C, Prevention of 1995). See also the discussion on this 110 of the CAA (general SIP Significant Deterioration (PSD) and part issue in the Cincinnati, Ohio 1-hour requirements). We are also proposing to D, New Source Review (NSR) permit ozone redesignation (65 FR 37890, June find that the Ohio SIP meets all SIP programs; include criteria for stationary 19, 2000), and in the Pittsburgh, requirements currently applicable for source emission control measures, Pennsylvania 1-hour ozone purposes of redesignation under part D monitoring and reporting; include redesignation (66 FR 50399, October 19, of title I of the CAA, in accordance with provisions for air quality modeling; and 2001). section 107(d)(3)(E)(v). We are provide for public and local agency We have reviewed the Ohio SIP and proposing to find that all applicable participation in planning and emission have concluded that it meets the general requirements of the Ohio SIP for control rule development. SIP requirements under section 110 of purposes of redesignation have been Section 110(a)(2)(D) of the CAA the CAA to the extent they are met, in accordance with section requires that SIPs contain measures to applicable for purposes of this 107(d)(3)(E)(ii). As discussed below, in prevent sources in a state from redesignation. EPA has previously this action EPA is proposing to approve significantly contributing to air quality approved provisions of Ohio’s SIP Ohio’s 2005 and 2008 emissions problems in another state. EPA believes addressing section 110 requirements, inventory, as well as the supplemental that the requirements linked with a including provisions addressing submission to the emissions inventory particular nonattainment area’s particulate matter, at 40 CFR 52.1870, of 2007 VOC and ammonia data made designation are the relevant measures to respectively). On December 5, 2007, and on April 30, 2013, as meeting the evaluate in reviewing a redesignation September 4, 2009, Ohio made section 172(c)(3) comprehensive request. The transport SIP submittal submittals addressing ‘‘infrastructure emissions inventory requirement. In requirements, where applicable, SIP’’ elements required under CAA making these proposed determinations, continue to apply to a state regardless of section 110(a)(2). EPA proposed we have ascertained which SIP the designation of any one particular approval of the December 5, 2007, requirements are applicable for area in the state. Thus, we believe that submittal on April 28, 2011, at 76 FR purposes of redesignation, and these requirements should not be 23757, and published final approval on concluded that SIP measures meeting construed to be applicable requirements July 14, 2011, at 76 FR 41075. The those requirements are approved or will for purposes of redesignation. requirements of section 110(a)(2), be approved by the time of final Further, we believe that the other however, are statewide requirements rulemaking. section 110 elements described above that are not linked to the PM2.5 a. Ohio Has Met All Applicable that are not connected with nonattainment status of the Canton- Requirements for Purposes of nonattainment plan submissions and Massillon area. Therefore, EPA believes Redesignation of the Canton-Massillon not linked with an area’s attainment that these SIP elements are not Area Under Section 110 and Part D of status are also not applicable applicable requirements for purposes of the CAA requirements for purposes of review of the state’s PM2.5 redesignation redesignation. A state remains subject to request. i. Section 110 General SIP Requirements these requirements after an area is Section 110(a) of title I of the CAA redesignated to attainment. We ii. Part D Requirements contains the general requirements for a conclude that only the section 110 and EPA is proposing to determine that, SIP. Section 110(a)(2) provides that the part D requirements that are linked with upon approval of the base year

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emissions inventories discussed in (attainment year) emissions inventories The requirement to determine section V.6. of this rulemaking, the Ohio for SO2, NOX, and directly emitted PM2.5 conformity applies to transportation SIP will meet the SIP requirements for as part of their redesignation request, plans, programs and projects developed, the Canton-Massillon area applicable for and Ohio supplemented these funded or approved under title 23 of the purposes of redesignation under part D inventories with emission inventories U.S. Code and the Federal Transit Act of the CAA. for VOC and ammonia on April 29, (transportation conformity), as well as to Subpart 1 of part D, found in sections 2013. As discussed below in section all other Federally-supported or funded 172–176 of the CAA, sets forth the basic V.6, EPA is approving both the 2005 and projects (general conformity). nonattainment requirements applicable 2008 base year inventory as meeting the Section 176(c) of the CAA was to all nonattainment areas. section 172(c)(3) emissions inventory amended by provisions contained in the requirement for the Canton-Massillon Safe, Accountable, Flexible, Efficient (1). Subpart 1 area. Transportation Equity Act: A Legacy for (a). Section 172 Requirements. Section 172(c)(4) requires the Users (SAFETEA–LU), which was For purposes of evaluating this identification and quantification of signed into law on August 10, 2005 redesignation request, the applicable allowable emissions for major new and (Pub. L. 109–59). Among the changes section 172 SIP requirements for the modified stationary sources in an area, Congress made to this section of the Canton-Massillon area are contained in and section 172(c)(5) requires source CAA were streamlined requirements for section 172(c)(1)–(9). A thorough permits for the construction and state transportation conformity SIPs. discussion of the requirements operation of new and modified major State transportation conformity contained in section 172 can be found stationary sources anywhere in the regulations must be consistent with in the General Preamble for nonattainment area. EPA approved Federal conformity regulations and Implementation of title I (57 FR 13498, Ohio’s current NSR program on January address three specific requirements April 16, 1992). 10, 2003 (68 FR 1366). Nonetheless, related to consultation, enforcement and Section 172(c)(1) requires the plans since PSD requirements will apply after enforceability. EPA believes that it is for all nonattainment areas to provide redesignation, the area need not have a reasonable to interpret the for the implementation of all fully-approved NSR program for transportation conformity SIP Reasonably Achievable Control purposes of this redesignation, provided requirements as not applying for Measures (RACM) as expeditiously as that the area demonstrates maintenance purposes of evaluating the redesignation practicable and to provide for of the NAAQS without part D NSR. A request under section 107(d) for two attainment of the primary NAAQS. EPA detailed rationale for this view is reasons. interprets this requirement to impose a described in a memorandum from Mary First, the requirement to submit SIP duty on all nonattainment areas to Nichols, Assistant Administrator for Air revisions to comply with the consider all available control measures and Radiation, dated October 14, 1994, transportation conformity provisions of and to adopt and implement such entitled, ’’Part D New Source Review the CAA continues to apply to areas measures as are reasonably available for Requirements for Areas Requesting after redesignation to attainment since implementation in each area as Redesignation to Attainment.’’ Ohio has such areas would be subject to a section components of the area’s attainment demonstrated that the Canton-Massillon 175A maintenance plan. Second, EPA’s demonstration. Because attainment has area will be able to maintain the Federal conformity rules require the been reached, no additional measures standard without part D NSR in effect; performance of conformity analyses in are needed to provide for attainment, therefore, the state need not have a fully the absence of Federally-approved state and section 172(c)(1) requirements are approved part D NSR program prior to rules. Therefore, because areas are no longer considered to be applicable as approval of the redesignation request. subject to the transportation conformity long as the area continues to attain the The state’s PSD program will become requirements regardless of whether they standard until redesignation. (40 CFR effective in the Canton-Massillon area are redesignated to attainment and, 51.1004(c).) upon redesignation to attainment. See because they must implement The Reasonable Further Progress rulemakings for Detroit, Michigan (60 conformity under Federal rules if state (RFP) requirement under section FR 12467–12468, March 7, 1995); rules are not yet approved, EPA believes 172(c)(2) is defined as progress that Cleveland-Akron-Lorain, Ohio (61 FR it is reasonable to view these must be made toward attainment. This 20458, 20469–20470, May 7, 1996); requirements as not applying for requirement is not relevant for purposes Louisville, Kentucky (66 FR 53665, purposes of evaluating a redesignation of redesignation because the Canton- October 23, 2001); and Grand Rapids, request. See Wall v. EPA, 265 F.3d 426 Massillon area has monitored Michigan (61 FR 31834–31837, June 21, (6th Cir. 2001), upholding this attainment of the 1997 annual and 2006 1996). interpretation. See also 60 FR 62748, 62749–62750 (Dec. 7, 1995) (Tampa, 24-hour PM2.5 NAAQS. (General Section 172(c)(6) requires the SIP to Preamble, 57 FR 13564). See also 40 contain control measures necessary to Florida). Ohio has an approved CFR 51.918. In addition, because the provide for attainment of the standard. transportation conformity SIP (72 FR Canton-Massillon area has attained the Because attainment has been reached, 20945). Ohio is in the process of updating its approved transportation 1997 annual and 2006 24-hour PM2.5 no additional measures are needed to NAAQS and is no longer subject to an provide for attainment. conformity SIP, and EPA will review its RFP requirement, the requirement to Section 172(c)(7) requires the SIP to provisions when they are submitted. submit the section 172(c)(9) contingency meet the applicable provisions of (2). Effect of the January 4, 2013, D.C. measures is not applicable for purposes section 110(a)(2). As noted above, we Circuit Decision Regarding PM2.5 of redesignation. Id. believe the Ohio’s SIP meets the Implementation under Subpart 4 Section 172(c)(3) requires submission requirements of section 110(a)(2) and approval of a comprehensive, applicable for purposes of (a). Background accurate and current inventory of actual redesignation. As discussed above, on January 4, emissions. Ohio submitted a 2005 (b) Section 176(c)(4)(D) Conformity 2013, in Natural Resources Defense (nonattainment year) and 2008 SIP Requirements. Council v. EPA, the D.C. Circuit

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remanded to EPA the ‘‘Final Clean Air redesignation request for the area, to the subsequent to the D.C. Circuit’s decision Fine Particle Implementation Rule’’ (72 extent that implementation under in South Coast Air Quality Mgmt. Dist. FR 20586, April 25, 2007) and the subpart 4 would impose additional v. EPA, 472 F.3d 882 (D.C. Cir. 2006). ‘‘Implementation of the New Source requirements for areas designated In South Coast, the Court found that Review (NSR) Program for Particulate nonattainment, EPA believes that those EPA was not permitted to implement Matter Less than 2.5 Micrometers requirements are not ‘‘applicable’’ for the 1997 8-hour ozone standard solely (PM2.5)’’ final rule (73 FR 28321, May the purposes of CAA section under subpart 1, and held that EPA was 16, 2008) (collectively, ‘‘1997 PM2.5 107(d)(3)(E), and thus EPA is not required under the statute to implement Implementation Rule’’). 706 F.3d 428 required to consider subpart 4 the standard under the ozone-specific (D.C. Cir. 2013). The Court found that requirements with respect to the requirements of subpart 2 as well. EPA erred in implementing the 1997 Canton-Massillon redesignation. Under Subsequent to the South Coast decision, PM2.5 NAAQS pursuant to the general its longstanding interpretation of the in evaluating and acting upon implementation provisions of subpart 1 CAA, EPA has interpreted section redesignation requests for the 1997 8- of part D of title I of the CAA, rather 107(d)(3)(E) to mean, as a threshold hour ozone standard that were than the particulate-matter-specific matter, that the part D provisions which submitted to EPA for areas under provisions of subpart 4 of part D of title are ‘‘applicable’’ and which must be subpart 1, EPA applied its longstanding I. Although the Court’s ruling did not approved in order for EPA to interpretation of the CAA that directly address the 2006 PM2.5 redesignate an area include only those ‘‘applicable requirements’’, for purposes standard, EPA is taking into account the which came due prior to a state’s of evaluating a redesignation, are those Court’s position on subpart 4 and the submittal of a complete redesignation that had been due at the time the 1997 PM2.5 standard in evaluating request. See ‘‘Procedures for Processing redesignation request was submitted. redesignations for the 2006 standard. Requests to Redesignate Areas to See, e.g., Proposed Redesignation of Attainment,’’ Memorandum from John (b). Proposal on This Issue Manitowoc County and Door County Calcagni, Director, Air Quality Nonattainment Areas (75 FR 22047, EPA is proposing to determine that Management Division, September 4, 22050, April 27, 2010). In those actions, the Court’s January 4, 2013, decision 1992 (Calcagni memorandum). See also EPA therefore did not consider subpart does not prevent EPA from ‘‘State Implementation Plan (SIP) 2 requirements to be ‘‘applicable’’ for redesignating the Canton-Massillon area Requirements for Areas Submitting the purposes of evaluating whether the to attainment. Even in light of the Requests for Redesignation to area should be redesignated under Court’s decision, redesignation for this Attainment of the Ozone and Carbon section 107(d)(3)(E). area is appropriate under the CAA and Monoxide (CO) NAAQS on or after EPA’s interpretation derives from the EPA’s longstanding interpretations of November 15, 1992,’’ Memorandum provisions of CAA Section 107(d)(3). the CAA’s provisions regarding from Michael Shapiro, Acting Assistant Section 107(d)(3)(E)(v) states that, for an redesignation. EPA first explains its Administrator, Air and Radiation, area to be redesignated, a state must longstanding interpretation that September 17, 1993 (Shapiro meet ‘‘all requirements ‘applicable’ to requirements that are imposed, or that memorandum); Final Redesignation of become due, after a complete Detroit-Ann Arbor, (60 FR 12459, the area under section 110 and part D’’. redesignation request is submitted for 12465–66, March 7, 1995); Final Section 107(d)(3)(E)(ii) provides that the an area that is attaining the standard are Redesignation of St. Louis, Missouri, (68 EPA must have fully approved the not applicable for purposes of FR 25418, 25424–27, May 12, 2003); ‘‘applicable’’ SIP for the area seeking evaluating a redesignation request. Sierra Club v. EPA, 375 F.3d 537, 541 redesignation. These two sections read Second, EPA then shows that, even if (7th Cir. 2004) (upholding EPA’s together support EPA’s interpretation of EPA applies the subpart 4 requirements redesignation rulemaking applying this ‘‘applicable’’ as only those requirements to the Canton-Massillon redesignation interpretation and expressly rejecting that came due prior to submission of a request and disregards the provisions of Sierra Club’s view that the meaning of complete redesignation request. First, its 1997 PM2.5 implementation rule ‘‘applicable’’ under the statute is holding states to an ongoing obligation recently remanded by the Court, the ‘‘whatever should have been in the plan to adopt new CAA requirements that state’s request for redesignation of this at the time of attainment rather than arose after the state submitted its area still qualifies for approval. EPA’s whatever actually was in the plan and redesignation request, in order to be discussion takes into account the effect already implemented or due at the time redesignated, would make it of the Court’s ruling on the area’s of attainment’’).1 In this case, at the time problematic or impossible for EPA to act maintenance plan, which EPA views as that Ohio submitted its redesignation on redesignation requests in accordance approvable when subpart 4 request, requirements under subpart 4 with the 18-month deadline Congress requirements are considered. were not due, [and indeed, were not yet set for EPA action in section 107(d)(3)(D). If ‘‘applicable (i). Applicable Requirements for known to apply.] EPA’s view that, for purposes of requirements’’ were interpreted to be a Purposes of Evaluating the evaluating the Canton-Massillon continuing flow of requirements with no Redesignation Request redesignation, the subpart 4 reasonable limitation, states, after With respect to the 1997 PM2.5 requirements were not due at the time submitting a redesignation request, Implementation Rule, the Court’s the state submitted the redesignation would be forced continuously to make January 4, 2013, ruling rejected EPA’s request is in keeping with the EPA’s additional SIP submissions that in turn reasons for implementing the PM2.5 interpretation of subpart 2 requirements would require EPA to undertake further NAAQS solely in accordance with the for subpart 1 ozone areas redesignated notice-and-comment rulemaking actions provisions of subpart 1, and remanded to act on those submissions. This would that matter to EPA, so that it could 1 Applicable requirements of the CAA that come create a regime of unceasing rulemaking address implementation of the 1997 due subsequent to the area’s submittal of a complete that would delay action on the PM NAAQS under subpart 4 of part D redesignation request remain applicable until a redesignation request beyond the 18- 2.5 redesignation is approved, but are not required as of the CAA, in addition to subpart 1. For a prerequisite to redesignation. Section 175A(c) of month timeframe provided by the CAA the purposes of evaluating Ohio’s the CAA. for this purpose.

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Second, a fundamental premise for determination effective as of the date of 1990,’’ 57 FR 13498 (April 16, 1992) redesignating a nonattainment area to that the statute required, rather than the (the ‘‘General Preamble’’). In the General attainment is that the area has attained later date on which EPA actually made Preamble, EPA discussed the the relevant NAAQS due to emission the determination. The Court rejected relationship of subpart 1 and subpart 4 reductions from existing controls. Thus, this view, stating that applying it SIP requirements, and pointed out that an area for which a redesignation ‘‘would likely impose large costs on subpart 1 requirements were to an request has been submitted would have states, which would face fines and suits extent ‘‘subsumed by, or integrally already attained the NAAQS as a result for not implementing air pollution related to, the more specific PM–10 of satisfying statutory requirements that prevention plans . . . even though they requirements.’’ 57 FR 13538 (April 16, came due prior to the submission of the were not on notice at the time.’’ Id. at 1992). The subpart 1 requirements request. Absent a showing that 68. Similarly, it would be unreasonable include, among other things, provisions unadopted and unimplemented to penalize the state of Ohio by rejecting for attainment demonstrations, RACM, requirements are necessary for future its redesignation request for an area that RFP, emissions inventories, and maintenance, it is reasonable to view is already attaining the 1997 PM2.5 contingency measures. the requirements applicable for standard and that met all applicable For the purposes of this redesignation, purposes of evaluating the redesignation requirements known to be in effect at in order to identify any additional request as including only those SIP the time of the request. For EPA now to requirements which would apply under requirements that have already come reject the redesignation request solely subpart 4, we are considering the due. These are the requirements that led because the state did not expressly Canton-Massillon area to be a to attainment of the NAAQS. To require, address subpart 4 requirements of ‘‘moderate’’ PM2.5 nonattainment area. for redesignation approval, that a state which it had no notice, would inflict the Under section 188 of the CAA, all areas also satisfy additional SIP requirements same unfairness condemned by the designated nonattainment areas under coming due after the state submits its Court in Sierra Club v. Whitman. subpart 4 would initially be classified by operation of law as ‘‘moderate’’ complete redesignation request, and (ii). Subpart 4 Requirements and Ohio nonattainment areas, and would remain while EPA is reviewing it, would Redesignation Request compel the state to do more than is moderate nonattainment areas unless necessary to attain the NAAQS, without Even if EPA were to take the view that and until EPA reclassifies the area as a a showing that the additional the Court’s January 4, 2013, decision ‘‘serious’’ nonattainment area. requirements are necessary for requires that, in the context of pending Accordingly, EPA believes that it is redesignations, subpart 4 requirements maintenance. appropriate to limit the evaluation of In the context of this redesignation, were due and in effect at the time the the potential impact of subpart 4 the timing and nature of the Court’s state submitted its redesignation requirements to those that would be January 4, 2013, decision in NRDC v. request, EPA proposes to determine that applicable to moderate nonattainment EPA compound the consequences of the Canton-Massillon area still qualifies areas. Sections 189(a) and (c) of subpart imposing requirements that come due for redesignation to attainment. As 4 apply to moderate nonattainment after the redesignation request is explained below, EPA believes that the areas and include the following: (1) An submitted. The state submitted its redesignation request for the Canton- approved permit program for redesignation request on July 5, 2011, Massillon area, though not expressed in construction of new and modified major but the Court did not issue its decision terms of subpart 4 requirements, stationary sources (section 189(a)(1)(A)); substantively meets the requirements of remanding EPA’s 1997 PM2.5 (2) an attainment demonstration (section implementation rule concerning the that subpart for purposes of 189(a)(1)(B)); (3) provisions for RACM applicability of the provisions of redesignating the area to attainment. (section 189(a)(1)(C)); and (4) With respect to evaluating the subpart 4 until January 2013. quantitative milestones demonstrating To require the state’s fully-completed relevant substantive requirements of RFP toward attainment by the and pending redesignation request to subpart 4 for purposes of redesignating applicable attainment date (section comply now with requirements of the Canton-Massillon area, EPA notes 189(c)). subpart 4 that the Court announced only that subpart 4 incorporates components The permit requirements of subpart 4, in January, 2013, would be to give of subpart 1 of part D, which contains as contained in section 189(a)(1)(A), retroactive effect to such requirements general air quality planning refer to and apply the subpart 1 permit when the state had no notice that it was requirements for areas designated as provisions requirements of sections 172 nonattainment. See Section 172(c). required to meet them. The D.C. Circuit and 173 to PM10, without adding to recognized the inequity of this type of Subpart 4 itself contains specific them. Consequently, EPA believes that planning and scheduling requirements section 189(a)(1)(A) does not itself retroactive impact in Sierra Club v. 3 Whitman, 285 F.3d 63 (D.C. Cir. 2002),2 for PM10 nonattainment areas, and impose for redesignation purposes any where it upheld the District Court’s under the Court’s January 4, 2013, additional requirements for moderate ruling refusing to make retroactive decision in NRDC v. EPA, these same areas beyond those contained in subpart EPA’s determination that the St. Louis statutory requirements also apply for 1.4 In any event, in the context of area did not meet its attainment PM2.5 nonattainment areas. EPA has redesignation, EPA has long relied on deadline. In that case, petitioners urged longstanding general guidance that the interpretation that a fully approved the Court to make EPA’s nonattainment interprets the 1990 amendments to the nonattainment new source review CAA, making recommendations to states program is not considered an applicable 2 Sierra Club v. Whitman was discussed and for meeting the statutory requirements requirement for redesignation, provided distinguished in a recent D.C. Circuit decision that for SIPs for nonattainment areas. See, the area can maintain the standard with addressed retroactivity in a quite different context, ‘‘State Implementation Plans; General a PSD program after redesignation. A where, unlike the situation here, EPA sought to give Preamble for the Implementation of its regulations retroactive effect. National detailed rationale for this view is Petrochemical and Refiners Ass’n v. EPA. 630 F.3d Title I of the Clear Air Act Amendments 145, 163 (D.C. Cir. 2010), rehearing denied 643 F.3d 4 The potential effect of section 189(e) on section 3 958 (D.C. Cir. 2011), cert denied 132 S. Ct. 571 PM10 refers to particulates nominally 10 189(a)(1)(A) for purposes of evaluating this (2011). micrometers in diameter or smaller. redesignation is discussed below.

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described in a memorandum from Mary due, those requirements do not apply to (iii). Subpart 4 and Control of PM2.5 Nichols, Assistant Administrator for Air an area that is attaining the 1997 and Precursors and Radiation, dated October 14, 1994, 2006 PM2.5 standard, for the purpose of The D.C. Circuit in NRDC v. EPA entitled, ‘‘Part D New Source Review evaluating a pending request to remanded to EPA the two rules at issue Requirements for Areas Requesting redesignate the area to attainment. EPA in the case with instructions to EPA to Redesignation to Attainment.’’ See also has consistently enunciated this re-promulgate them consistent with the rulemakings for Detroit, Michigan (60 interpretation of applicable requirements of subpart 4. EPA in this FR 12467–12468, March 7, 1995); requirements under section 107(d)(3)(E) section addresses the Court’s opinion Cleveland-Akron-Lorain, Ohio (61 FR since the General Preamble was with respect to PM precursors. While 20458, 20469–20470, May 7, 1996); 2.5 published more than twenty years ago. past implementation of subpart 4 for Louisville, Kentucky (66 FR 53665, Courts have recognized the scope of PM has allowed for control of PM October 23, 2001); and Grand Rapids, 10 10 EPA’s authority to interpret ‘‘applicable precursors such as NO from major Michigan (61 FR 31834–31837, June 21, X requirements’’ in the redesignation stationary, mobile, and area sources in 1996). With respect to the specific context. See Sierra Club v. EPA, 375 order to attain the standard as attainment planning requirements under F.3d 537 (7th Cir. 2004). expeditiously as practicable, CAA subpart 4,5 when EPA evaluates a Moreover, even outside the context of section 189(e) specifically provides that redesignation request under either redesignations, EPA has viewed the control requirements for major subpart 1 and/or 4, any area that is obligations to submit attainment-related stationary sources of direct PM10 shall also apply to PM10 precursors from attaining the PM2.5 standard is viewed SIP planning requirements of subpart 4 those sources, except where EPA as having satisfied the attainment as inapplicable for areas that EPA determines that major stationary sources planning requirements for these determines are attaining the standard. of such precursors ‘‘do not contribute subparts. For redesignations, EPA has EPA’s prior ‘‘Clean Data Policy’’ significantly to PM10 levels which for many years interpreted attainment- rulemakings for the PM10 NAAQS, also linked requirements as not applicable exceed the standard in the area.’’ governed by the requirements of subpart EPA’s 1997 PM implementation for areas attaining the standard. In the 4, explain EPA’s reasoning. They 2.5 General Preamble, EPA stated that: rule, remanded by the D.C. Circuit, describe the effects of a determination of contained rebuttable presumptions The requirements for RFP will not apply in attainment on the attainment-related SIP concerning certain PM precursors evaluating a request for redesignation to 2.5 planning requirements of subpart 4. See applicable to attainment plans and attainment since, at a minimum, the air ‘‘Determination of Attainment for Coso quality data for the area must show that the control measures related to those plans. area has already attained. Showing that the Junction Nonattainment Area,’’ (75 FR Specifically, in 40 CFR 51.1002, EPA state will make RFP towards attainment will, 27944, May 19, 2010). See also Coso provided, among other things, that a therefore, have no meaning at that point. Junction proposed PM10 redesignation, state was ‘‘not required to address VOC ‘‘General Preamble for the Interpretation (75 FR 36023, 36027, June 24, 2010); [and ammonia] as . . . PM2.5 attainment of Title I of the CAA Amendments of Proposed and Final Determinations of plan precursor[s] and to evaluate 1990’’; (57 FR 13498, 13564, April 16, Attainment for San Joaquin sources of VOC [and ammonia] 1992). Nonattainment Area (71 FR 40952, emissions in the state for control The General Preamble also explained 40954–55, July 19, 2006; and 71 FR measures.’’ EPA intended these to be that 63641, 63643–47 October 30, 2006). In rebuttable presumptions. EPA [t]he section 172(c)(9) requirements are short, EPA in this context has also long established these presumptions at the directed at ensuring RFP and attainment by concluded that to require states to meet time because of uncertainties regarding the applicable date. These requirements no superfluous SIP planning requirements the emission inventories for these longer apply when an area has attained the is not necessary and not required by the pollutants and the effectiveness of standard and is eligible for redesignation. CAA, so long as those areas continue to specific control measures in various Furthermore, section 175A for maintenance attain the relevant NAAQS. regions of the country in reducing PM2.5 plans . . . provides specific requirements for concentrations. EPA also left open the contingency measures that effectively Elsewhere in this notice, EPA possibility for such regulation of VOC supersede the requirements of section proposes to determine that the area has and ammonia in specific areas where 172(c)(9) for these areas. attained the 1997 and 2006 PM 2.5 that was necessary. standards. Under its longstanding Id. The Court in its January 4, 2013, EPA similarly stated in its 1992 interpretation, EPA is proposing to decision made reference to both section Calcagni memorandum that, ‘‘The determine here that the area meets the 189(e) and 40 CFR 51. 1002, and stated requirements for reasonable further attainment-related plan requirements of that, ‘‘In light of our disposition, we progress and other measures needed for subparts 1 and 4. need not address the petitioners’ attainment will not apply for Thus, EPA is proposing to conclude challenge to the presumptions in [40 redesignations because they only have that the requirements to submit an CFR 51.1002] that volatile organic meaning for areas not attaining the attainment demonstration under compounds and ammonia are not PM standard.’’ 2.5 It is evident that even if we were to 189(a)(1)(B), a RACM determination precursors, as subpart 4 expressly consider the Court’s January 4, 2013, under section 172(c)1 and section governs precursor presumptions.’’ decision in NRDC v. EPA to mean that 189(a)(1)(c), a RFP demonstration under NRDC v. EPA, at 27, n.10. attainment-related requirements specific 189(c)(1), and contingency measure Elsewhere in the Court’s opinion, to subpart 4 should be imposed requirements under section 172(c)(9) are however, the Court observed: retroactively 6 and thus are now past satisfied for purposes of evaluating the Ammonia is a precursor to fine particulate redesignation request. matter, making it a precursor to both PM2.5 5 I.e., attainment demonstration, RFP, RACM, and PM10. For a PM10 nonattainment area milestone requirements, contingency measures. interpreted so as to impose these requirements on governed by subpart 4, a precursor is 6 As EPA has explained above, we do not believe the states retroactively. Sierra Club v. Whitman, presumptively regulated. See 42 U.S.C. that the Court’s January 4, 2013 decision should be supra. § 7513a(e) [section 189(e)].

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Id. at 21, n.7. For a number of reasons, additional controls of ammonia and Although, as EPA has emphasized, its EPA believes that its proposed VOC are required in the context of this consideration here of precursor redesignation of the Canton-Massillon redesignation. requirements under subpart 4 is in the area is consistent with the Court’s In the General Preamble, EPA context of a redesignation to attainment, decision on this aspect of subpart 4. discusses its approach to implementing EPA’s existing interpretation of subpart First, while the Court, citing section section 189(e). See 57 FR 13538–13542. 4 requirements with respect to 189(e), stated that ‘‘for a PM10 area With regard to precursor regulation precursors in attainment plans for PM10 governed by subpart 4, a precursor is under section 189(e), the General contemplates that states may develop ‘presumptively regulated,’’’ the Court Preamble explicitly stated that control attainment plans that regulate only expressly declined to decide the specific of VOCs under other Act requirements those precursors that are necessary for challenge to EPA’s 1997 PM2.5 may suffice to relieve a state from the purposes of attainment in the area in implementation rule provisions need to adopt precursor controls under question, i.e., states may determine that regarding ammonia and VOC as section 189(e) (57 FR 13542). EPA in only certain precursors need be precursors. The Court had no occasion this proposal proposes to determine that regulated for attainment and control to reach whether and how it was the SIP has met the provisions of section purposes.9 Courts have upheld this substantively necessary to regulate any 189(e) with respect to ammonia and approach to the requirements of subpart 10 specific precursor in a particular PM2.5 VOCs as precursors. This proposed 4 for PM10. EPA believes that nonattainment area, and did not address determination is based on our findings application of this approach to PM2.5 what might be necessary for purposes of that (1) the Canton-Massillon area precursors under subpart 4 is acting upon a redesignation request. contains no major stationary sources of reasonable. Because the Canton- However, even if EPA takes the view ammonia, and (2) existing major Massillon area has already attained the that the requirements of subpart 4 were stationary sources of VOC are 1997 and 2006 PM2.5 NAAQS with its deemed applicable at the time the state adequately controlled under other current approach to regulation of PM2.5 submitted the redesignation request, provisions of the CAA regulating the precursors, EPA believes that it is and disregards the implementation ozone NAAQS.8 In the alternative, EPA reasonable to conclude in the context of rule’s rebuttable presumptions regarding proposes to determine that, under the this redesignation that there is no need ammonia and VOC as PM2.5 precursors, express exception provisions of section to revisit the attainment control strategy (and any similar provisions reflected in 189(e), and in the context of the with respect to the treatment of the guidance for the 2006 PM2.5 redesignation of the area, which is precursors. Even if the Court’s decision standard) the regulatory consequence attaining the 1997 annual PM2.5 is construed to impose an obligation, in would be to consider the need for standard, at present ammonia and VOC evaluating this redesignation request, to regulation of all precursors from any precursors from major stationary consider additional precursors under sources in the area to demonstrate sources do not contribute significantly subpart 4, it would not affect EPA’s attainment and to apply the section to levels exceeding the 1997 PM2.5 approval here of Ohio’s request for 189(e) provisions to major stationary standard in the Canton-Massillon area. redesignation of the Canton-Massillon sources of precursors. In the case of See 57 FR 13539–42. area. In the context of a redesignation, Canton-Massillon, EPA believes that EPA notes that its 1997 PM2.5 the area has shown that it has attained doing so is consistent with proposing implementation rule provisions in 40 both standards. Moreover, the state has redesignation of the area for the 1997 CFR 51.1002 were not directed at shown and EPA is proposing to PM standard. The Canton-Massillon 2.5 evaluation of PM precursors in the determine that attainment in this area is area has attained both standards without 2.5 context of redesignation, but at SIP due to permanent and enforceable any specific additional controls of VOC plans and control measures required to emissions reductions on all precursors and ammonia emissions from any bring a nonattainment area into necessary to provide for continued sources in the area. attainment. It follows logically that no Precursors in subpart 4 are attainment of the 1997 PM2.5 NAAQS. further control of additional precursors specifically regulated under the By contrast, redesignation to attainment is necessary. Accordingly, EPA does not provisions of section 189(e), which primarily requires the area to have view the January 4, 2013, decision of the requires, with important exceptions, already attained due to permanent and Court as precluding redesignation of the control requirements for major enforceable emission reductions, and to demonstrate that controls in place can Canton-Massillon area to attainment for stationary sources of PM precursors.7 10 continue to maintain the standard. the 1997 PM Under subpart 1 and EPA’s prior 2.5 NAAQS at this time. Thus, even if we regard the Court’s implementation rule, all major In sum, even if Ohio were required to January 4, 2013, decision as calling for address precursors for the Canton- stationary sources of PM precursors 2.5 ‘‘presumptive regulation’’ of ammonia Massillon area under subpart 4 rather were subject to regulation, with the and VOC for PM than under subpart 1, as interpreted in exception of ammonia and VOC. Thus 2.5 under the attainment EPA’s remanded PM we must address here whether planning provisions of subpart 4, those 2.5 implementation additional controls of ammonia and provisions in and of themselves do not rule, EPA would still conclude that the VOC from major stationary sources are require additional controls of these area had met all applicable required under section 189(e) of subpart precursors for an area that already requirements for purposes of 4 in order to redesignate the area for the qualifies for redesignation. Nor does EPA believe that requiring Ohio to 9 1997 PM standard. As explained See, e.g., ‘‘Approval and Promulgation of 2.5 address precursors differently than they Implementation Plans for California—San Joaquin below, we do not believe that any have already would result in a Valley PM–10 Nonattainment Area; Serious Area Plan for Nonattainment of the 24-Hour and Annual 7 Under either subpart 1 or subpart 4, for substantively different outcome. PM–10 Standards,’’ 69 FR 30006 (May 26, 2004) purposes of demonstrating attainment as (approving a PM10 attainment plan that impose expeditiously as practicable, a state is required to 8 The Canton-Massillon area has reduced VOC controls on direct PM10 and NOX emissions and did evaluate all economically and technologically emissions through the implementation of various not impose controls on SO2, VOC, or ammonia feasible control measures for direct PM emissions SIP approved VOC control programs and various emissions). and precursor emissions, and adopt those measures on-road and nonroad motor vehicle control 10 See, e.g., Assoc. of Irritated Residents v. EPA that are deemed reasonably available. programs. et al., 423 F.3d 989 (9th Cir. 2005).

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redesignation in accordance with maintenance plan as satisfying this (light duty vehicles)—77%; light duty section 107(d)(3(E)(ii) and (v). requirement. trucks, minivans, and sports utility No SIP provisions applicable for vehicles—86%; and, larger sports utility b. The Canton-Massillon Area Has a redesignation of the Canton-Massillon vehicles, vans, and heavier trucks—69% Fully Approved Applicable SIP Under area are currently disapproved, to 95%. EPA expects fleet wide average Section 110(k) of the CAA conditionally approved or partially emissions to come to decline by similar Upon final approval of Ohio’s approved. If EPA approves Ohio’s percentages as new vehicles replace comprehensive emissions inventories, Canton-Massillon area PM2.5 emissions older vehicles. The Tier 2 standards also EPA will have fully approved the Ohio inventories as proposed, Ohio will have reduced the sulfur content of gasoline to SIP for the Canton-Massillon area under a fully approved SIP for all 30 parts per million (ppm) beginning in section 110(k) of the CAA for all requirements applicable for purposes of January 2006. Most gasoline sold in requirements applicable for purposes of redesignation. Ohio prior to January 2006 had a sulfur redesignation to attainment for the 1997 content of about 500 ppm. 3. The Improvement in Air Quality Is annual and 2006 24-hour PM2.5 Heavy-Duty Diesel Engine Rule. EPA standard. EPA may rely on prior SIP Due to Permanent and Enforceable issued this rule in July 2000. This rule approvals in approving a redesignation Reductions in Emissions Resulting From includes standards limiting the sulfur request (See page 3 of the Calcagni Implementation of the SIP and content of diesel fuel, which went into Memorandum; Southwestern Applicable Federal Air Pollution effect in 2004. A second phase took Pennsylvania Growth Alliance v. Control Regulations and Other effect in 2007 which reduced fine Browner, 144 F.3d 984, 989–990 (6th Permanent and Enforceable Reductions particle emissions from heavy-duty Cir. 1998); Wall v. EPA, 265 F.3d 426 (Section 107(d)(3)(E)(iii)) highway engines and further reduced (6th Cir. 2001)), plus any additional EPA believes that Ohio has the highway diesel fuel sulfur content to measures it may approve in conjunction demonstrated that the observed air 15 ppm. The total program is estimated with a redesignation action. See 68 FR quality improvement in the Canton- to achieve a 90% reduction in direct 25413, 25426 (May 12, 2003). Since the Massillon area is due to permanent and PM2.5 emissions and a 95% reduction in passage of the CAA of 1970, Ohio has enforceable reductions in emissions NOX emissions for these new engines adopted and submitted, and EPA has resulting from implementation of the using low sulfur diesel, compared to fully approved, provisions addressing SIP, Federal measures and other state- existing engines using higher sulfur various required SIP elements under adopted measures. content diesel. The reduction in fuel particulate matter standards. In this In making this demonstration, Ohio sulfur content also yielded an action, as discussed in section V.6 EPA has calculated the change in emissions immediate reduction in sulfate particle is proposing to approve Ohio’s base year between 2005, one of the years used to emissions from all diesel vehicles. emissions inventories for the Canton- designate the Canton-Massillon area as Nonroad Diesel Rule. In May 2004, Massillon area as meeting the nonattainment, and 2008, one of the EPA promulgated a new rule for large requirement of section 172(c)(3) of the years the Canton-Massillon area nonroad diesel engines, such as those CAA for the 1997 annual and 2006 24- monitored attainment. The reduction in used construction, agriculture and hour PM2.5 standard. emissions and the corresponding mining equipment, to be phased in between 2008 and 2014. The rule also c. Nonattainment Requirements improvement in air quality over this time period can be attributed to a reduces the sulfur content in nonroad Under section 172, states with number of regulatory control measures diesel fuel by over 99%. Prior to 2006, nonattainment areas must submit plans that the Canton-Massillon area and nonroad diesel fuel averaged providing for timely attainment and contributing areas have implemented in approximately 3,400 ppm sulfur. This meeting a variety of other requirements. recent years. rule limited nonroad diesel sulfur On July 16, 2008, Ohio submitted a content to 500 ppm by 2006, with a state-wide attainment demonstration for a. Permanent and Enforceable Controls further reduction to 15 ppm by 2010. PM2.5, including the Canton-Massillon Implemented The combined engine and fuel rules will area. However, EPA’s determination that The following is a discussion of reduce NOX and PM emissions from the area attained the 1997 PM2.5 annual permanent and enforceable measures large nonroad diesel engines by over and 2006 24-hour standards (76 FR that have been implemented in the area: 90%, compared to current nonroad 56641; 77 FR 28264, respectively) engines using higher sulfur content suspended the requirement to submit i. Federal Emission Control Measures diesel. It is estimated that compliance certain planning SIPs related to Reductions in fine particle precursor with this rule will cut NOX emissions attainment, including attainment emissions have occurred statewide and from nonroad diesel engines by up to demonstration requirements, the in upwind areas as a result of Federal 90%. This rule achieved some emission Reasonably Achievable Control emission control measures, with reductions by 2008 and was fully Technology (RACT)-RACM requirement additional emission reductions expected implemented by 2010. The reduction in of section 172(c)(1) of the CAA, the RFP to occur in the future. Federal emission fuel sulfur content also yielded an and attainment demonstration control measures include the following: immediate reduction in sulfate particle requirements of sections 172(c)(2) and Tier 2 Emission Standards for emissions from all diesel vehicles. (6) and 182(b)(1) of the CAA and the Vehicles and Gasoline Sulfur Standards. Nonroad Large Spark-Ignition Engine requirement for contingency measures These emission control requirements and Recreational Engine Standards. In of section 172(c)(9) of the CAA). result in lower NOX and SO2 emissions November 2002 EPA promulgated As a result, the only remaining from new cars and light duty trucks, emission standards for groups of requirement under section 172 to be including sport utility vehicles. The previously unregulated nonroad considered is the emissions inventory Federal rules were phased in between engines. These engines include large required under section 172(c)(3). As 2004 and 2009. The EPA has estimated spark-ignition engines such as those discussed in section V.6, EPA is that, by the end of the phase-in period, used in forklifts and airport ground- proposing to approve the inventory that new vehicles will emit the following service equipment; recreational vehicles Ohio submitted as part of its percentages less NOX: Passenger cars using spark-ignition engines such as off-

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highway motorcycles, all-terrain emissions from the base-year inventory. b. Emission Reductions vehicles and snowmobiles; and In addition, regional emissions will not recreational marine diesel engines. affect the attainment or maintenance of Ohio developed emissions inventories Emission standards from large spark- the Canton-Massillon area. Modeling for NOX, direct PM2.5 and SO2 for 2005, ignition engines were implemented in conducted by EPA during the CSAPR one of the years used to designate the two tiers, with Tier 1 starting in 2004 rulemaking process demonstrates that area as nonattainment, and 2008, one of and Tier 2 in 2007. Recreational vehicle the counties in the Canton-Massillon the years the Canton-Massillon area emission standards are being phased in PM2.5 nonattainment area will have monitored attainment of the standard. from 2006 through 2012. Marine Diesel concentrations below the 1997 annual Area source emissions the Canton- engine standards were phased in from and the 2006 24-hour PM2.5 standards in Massillon area for 2005 were taken from 2006 through 2009. With full both 2012 and 2014 without taking into periodic emissions inventories.11 These implementation of the nonroad spark- account emissions reductions from 2005 area source emission estimates ignition engine and recreational engine CAIR or CSAPR. See ‘‘Air Quality were extrapolated to 2008. Source standards, an 80% reduction in NOX Modeling Final Rule Technical Support growth factors were supplied by the expected by 2020. Some of these Document’’, App. B. This modeling is Lake Michigan Air Directors Consortium emission reductions occurred by the available in the docket for this proposed (LADCO). 2008–2010 period used to demonstrate redesignation action. Nonroad mobile source emissions attainment, and additional emission Moreover, in its August 2012 were extrapolated from nonroad mobile reductions will occur during the decision, the Court also ordered EPA to maintenance period. continue implementing CAIR. See EME source emissions reported in EPA’s Homer City Generation LP v. EPA, 696 2005 National Emissions Inventory ii. Control Measures in Contributing F.3d 7 (D.C. Cir. 2012). In sum, neither (NEI). Contractors were employed by Areas the current status of CAIR nor the LADCO to estimate emissions for NOX SIP Call. On October 27, 1998 current status of CSAPR affects any of commercial marine vessels and (63 FR 57356), EPA issued a NOX SIP the criteria for proposed approval of this railroads. Call requiring the District of Columbia redesignation request for the Canton- On-road mobile source emissions and 22 states to reduce emissions of Massillon area. were calculated using EPA’s mobile NOX. Affected states were required to source emission factor model, iii. Consent Decrees comply with Phase I of the SIP Call MOVES2010a, in conjunction with beginning in 2004, and with Phase II On December 31, 2012, the Marathon transportation model results developed beginning in 2007. Emission reductions petroleum refinery in Canton was by the Stark County Area Transportation resulting from regulations developed in required by a Federal consent decree to Study (SCATS). response to the NO SIP Call are shut down an open waste gas flare, X All emissions estimates discussed permanent and enforceable. resulting in reductions of VOCs, SO2 CAIR. The Canton-Massillon area has and direct PM. The Canton refinery is below were documented in the demonstrated that attainment of the also required under this consent decree submittal and appendices of Ohio’s 1997 8-hour ozone NAAQS will be to meet specific limits on their capped redesignation request submittal from maintained with or without the gas flare that must be incorporated into April 16, 2012, and their April 30, 2013, implementation of CAIR or CSAPR. The the permanent construction permit. supplemental submittal. For these data Canton-Massillon area has no local These emission reductions will add to and additional emissions inventory electric generating units (EGUs) that continued reductions for other sources data, the reader is referred to EPA’s would be impacted by CAIR or CSAPR, in the area throughout the maintenance digital docket for this rule, http:// and in fact, the area’s emissions are period. In a 2011 state consent decree, www.regulations.gov, which includes dominated by mobile sources (Table 2). Akron Iron & Metal, LLC, in Canton, digital copies of Ohio’s submittal. Mobile sources in the area comprise added baghouse controls resulting in Emissions data in tpy for the Canton- 85% of the NOX emissions, 38% of the reductions of direct PM in the Canton Massillon area are shown in Tables 2 SO2 emission, and 46% of the PM2.5 area. and 3, below.

TABLE 2—SUMMARY OF 2005 EMISSIONS OF SO2, NOX, AND DIRECTLY EMITTED PM2.5 FOR THE CANTON-MASSILLON AREA BY SOURCE TYPE [tpy]

SO2 NOX PM2.5

Point (EGU) ...... 0.00 0.00 0.00 Non-EGU ...... 553.14 1,129.41 380.10 On-road ...... 191.33 14,004.65 433.47 Nonroad ...... 261.01 2,801.96 231.64 Area ...... 163.72 1,313.88 370.87 MAR ...... 38.35 537.27 14.58

Total Canton-Massillon ...... 1,207.55 19,787.17 1,430.66

11 Periodic emission inventories are derived by the Federal Consolidated Emissions Reporting Rule, rule published on December 17, 2008, at 73 FR states every three years and reported to the EPA. codified at 40 CFR Subpart A. EPA revised these 76539. These periodic emission inventories are required by and other emission reporting requirements in a final

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TABLE 3—COMPARISON OF PM2.5, NOX, AND SO2 EMISSIONS FROM A NONATTAINMENT YEAR (2005) AND EMISSIONS FOR AN ATTAINMENT YEAR (2008) FOR THE CANTON-MASSILLON AREA [tpy]

Net change 2005 2008 (2005–2008)

PM2.5 ...... 1,430.66 1,257.11 ¥173.55 NOX ...... 19,787.17 16,227.26 ¥3,559.91 SO2 ...... 1,207.55 906.79 ¥300.76

Table 3 shows that the Canton- years after EPA approves a SIP to include a maintenance plan for Massillon area shows a decrease in redesignation to attainment. Eight years the Canton-Massillon area, as required direct PM2.5 emissions by 173.55 tons, after redesignation, the state must by section 175A of the CAA. Section the area reduced NOX emissions by submit a revised maintenance plan 175A requires a state seeking 3,559.91tons and SO2 emissions by which demonstrates that attainment will redesignation to attainment to submit a 300.76 tons between 2005, a continue to be maintained for ten years SIP revision to provide for the nonattainment year, and 2008, an following the initial ten year maintenance of the NAAQS in the area attainment year. Ohio did not attribute maintenance period. To address the ‘‘for at least 10 years after the attainment to any changes in VOC or possibility of future NAAQS violations, redesignation.’’ EPA has interpreted this ammonia emissions; instead to changes the maintenance plan must contain as a showing of maintenance ‘‘for a in SO , NO , and PM emissions. EPA contingency measures with a schedule 2 X 2.5 period of ten years following agrees that emission reductions from for implementation as EPA deems sources of SO , NO , and PM brought necessary to assure prompt correction of redesignation.’’ Calcagni Memorandum, 2 X 2.5 p.9. Where the emissions inventory the area into attainment, with most any future annual PM2.5 violations. emission reductions occurring from The Calcagni Memorandum provides method of showing maintenance is Federal mobile source engine standards additional guidance on the content of a used, its purpose is to show that and fuel standards (Table 2 and 3). maintenance plan. The memorandum emissions during the maintenance Based on the information summarized states that a maintenance plan should period will not increase over the above, Ohio has adequately address the following items: the attainment year inventory. Calcagni demonstrated that the improvement in attainment emissions inventories, a Memorandum, pp. 9–10. air quality is due to permanent and maintenance demonstration showing Ohio’s submission uses emissions enforceable emissions reductions. maintenance for the ten years of the inventory projections for the years 2015 maintenance period, a commitment to and 2025 to demonstrate maintenance 4. Ohio Has a Fully Approved maintain the existing monitoring for the Canton-Massillon area. The Maintenance Plan Pursuant to Section network, factors and procedures to be projected emissions were estimated by 175A of the CAA (Section used for verification of continued 107(d)(3)(E)(iv)) attainment of the NAAQS and a Ohio, with assistance from LADCO and In conjunction with Ohio’s request to contingency plan to prevent or correct SCATS using the MOVES2010a model. redesignate the Canton-Massillon future violations of the NAAQS. The 2015 interim year emissions were nonattainment area to attainment status, projected using estimates based on the Ohio has submitted a SIP revision to b. Attainment Inventory 2009 and 2018 LADCO modeling provide for maintenance of the 1997 Ohio developed emissions inventories inventory, using LADCO’s growth annual and 2006 24-hour PM2.5 NAAQS for NOX, direct PM2.5 and SO2 for 2008, factors, for all sectors. The 2025 in the area through 2025. one of the years in the period during maintenance year inventory is based on which the Canton-Massillon area a. What is required in a maintenance emissions estimates from the 2018 monitored attainment of the 1997 plan? LADCO modeling. Table 4 shows the annual and 2006 24-hour PM2.5 2008 attainment base year emission Section 175A of the CAA sets forth standard, as described previously. The estimates and the 2015 and 2025 the required elements of a maintenance attainment levels of emissions for the emission projections for NOX, direct plan for areas seeking redesignation area are summarized in Tables 3, above. PM and SO for the Canton-Massillon from nonattainment to attainment. 2.5 2 Under section 175A, the plan must c. Demonstration of Maintenance area that Ohio provided in its April 16, demonstrate continued attainment of Along with the redesignation request, 2012 submission. the applicable NAAQS for at least ten Ohio submitted a revision to its PM2.5

TABLE 4—COMPARISON OF 2008, 2015 AND 2025 NOX, DIRECT PM2.5 AND SO2 EMISSION TOTALS (TPY) FOR THE CANTON-MASSILLON AREA

SO2 NOX PM2.5

2008 (baseline) ...... 906.79 16,227.26 1,257.11 2015 ...... 812.89 11,001.32 1,088.72 2025 ...... 795.30 7,822.67 912.92 Change 2008–2025 ...... ¥111.49 ¥8,404.59 ¥344.19 12% 52% 27% decrease decrease decrease

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Table 4 shows that the Canton- in this area. As explained below, based 2005 and 2008. Future compliance with Massillon area reduced NOX emissions upon documentation provided by the mobile source standards is also by 8,404.59 tpy between 2008 and the state and supporting information, EPA projected to reduce NOX by maintenance projection to 2025, direct believes that the maintenance plan for approximately 700 tpy and PM2.5 by PM2.5 emissions by 344.19 tpy, and the Canton-Massillon area need not approximately 200 tpy between 2008 reduced SO2 emissions by 111.49 tpy include any additional emission and 2025. between 2008 and 2025. reductions of VOC or ammonia in order Ohio’s maintenance plan shows a EPA in this proposal is also to provide for continued maintenance of projected reduction of NO emissions considering the effect of the Court’s X the standard. by 8,404.59 tpy between 2008 and the remand of EPA’s implementation rule, in particular the remand of First, as noted above in EPA’s maintenance projection to 2025, direct presumptions against consideration of discussion of section 189(e), VOC PM2.5 emissions of 344.19 tpy, and emission levels in this area have reduced SO2 emissions of 111.49 tpy VOC and ammonia as PM2.5 precursors, on requirements for the maintenance historically been well-controlled under between 2008 and 2025. See Table 4 plan mandated under sections 175A and SIP requirements related to ozone and above. In addition, emissions 107(d)(3)(E)(iv). To begin with, EPA other pollutants. Second, total ammonia inventories used in EPA’s regulatory notes that the area has attained the 1997 emissions throughout the Canton- impact analysis (RIA) for the 2012 PM2.5 Massillon area are low, estimated to be NAAQS show that VOC emissions are and 2006 PM2.5 standard and that the state has shown that attainment of those less than 1,700 tpy. See Table 5 below. projected to decrease by 720 tpy, standards is due to permanent and This amount of ammonia emissions respectively between 2007 and 2020. enforceable emission reductions. appears especially small in comparison Ammonia emissions are projected to EPA proposes to determine that the to the total amounts of NOX, and VOCs increase slightly between 2007 and 2020 state’s maintenance plan shows from sources in the area. Both VOC and by 8 tpy, which is expected to have continued maintenance of the standard NOX are also well controlled in the minimal air quality impact, an impact by tracking the levels of the precursors Canton-Massillon area and have that will be more than compensated by whose control brought about attainment decreased due to permanent and the significant emissions reductions of the 1997 and 2006 PM2.5 standard in enforceable measures such as RACT projected in direct PM2.5, SO2, and NOX. the Canton-Massillon area. EPA rules controlling stationary sources See Table 5. Given that all emissions therefore believes that the only previously approved (75 FR 65572; OAC except ammonia decrease significantly additional consideration related to the 3745–17; OAC 3745–110). Additional below attainment year levels, providing maintenance plan requirements that significant reductions resulted from a large margin of safety, the minimal results from the Court’s January 4, 2013, Federal mobile source standards increase in ammonia would not be decision is that of assessing the discussed above, accounting for 3,536 expected to impact the areas ability to potential role of VOC and ammonia in tpy of the NOX reductions in the area attain either the 1997 or 2006 PM2.5 demonstrating continued maintenance and 665 tpy of PM2.5 reductions between NAAQS.

TABLE 5—COMPARISON OF 2007 AND 2020 VOC AND AMMONIA EMISSION TOTALS BY SOURCE SECTOR (TPY) FOR THE CANTON-MASSILLON AREA 1

Ammonia VOCs Net change Net change 2007 2020 2007–2020 2007 2020 2007–2020

Point ...... 21.29 20.40 ¥0.89 919.30 901.40 ¥17.90 Area ...... 1491.50 1564.69 73.20 4825.67 4846.99 21.32 Nonroad ...... 2.66 3.04 0.38 2723.36 1612.89 ¥1110.47 On-road ...... 148.98 84.33 ¥64.65 5199.46 1847.15 ¥3352.30 Fires ...... 1.69 1.69 0.00 24.28 24.28 0.00

Total ...... 1666.11 1674.16 8.04 13692.06 9232.71 ¥4459.35

1 These emissions estimates were taken from the emissions inventories developed for the RIA for the 2012 PM2.5 NAAQS which can be found in the docket.

The current air quality design values the Canton-Massillon area is 10.8 mg/m3. After consideration of the DC Circuit’s 3 for the area are 13.0 and 29 mg/m Given that NOX, SO2, PM2.5, and VOC January 4, 2013, decision, and for the (based on 2010–2012 air quality data), emissions are projected to decrease reasons set forth in this notice, EPA which are well below the 1997 annual through 2025, and given that ammonia proposes to approve the state’s and 2006 24-hour PM2.5 NAAQS of 15 emissions are expected to remain maintenance plan and its request to and 35 mg/m3. In addition, available air relatively constant, it is reasonable to redesignate the Canton-Massillon area to quality modeling analyses show conclude that monitored PM2.5 levels in attainment for the PM2.5 1997 annual continued maintenance of the standard this area will continue to decrease and 2006 24-hour NAAQS. during the maintenance period. The through 2025. As described in section V.3.b of this modeling analysis conducted for the Thus, EPA believes that there is action, the result of Federal rules and RIA for the 2012 PM2.5 NAAQS ample justification to conclude that the consent decree actions, demonstrate that indicates that the design value for this Canton-Massillon area will continue to the reductions in emissions from point, area is expected to continue to decline maintain the standard, even taking into area, and mobile sources in the Canton- through 2020. In the RIA analysis, the consideration the emissions of other Massillon area have occurred and are highest 2020 modeled design value for precursors potentially relevant to PM2.5. mandated to continue to occur through

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2025 and beyond. Thus the emissions the state. The state should also identify f. Fleet vehicles; inventories set forth in Table 4 show specific indicators to be used to g. Concrete manufacturers and; that the area will continue to maintain determine when the contingency h. Aggregate processing plants. the annual PM2.5 standard during the measures need to be adopted and Ohio further commits to conduct maintenance period at least through implemented. The maintenance plan ongoing review of its data, and if 2025. must include a requirement that the monitored concentrations or emissions Based on the information summarized state will implement all measures with are trending upward, Ohio commits to above, Ohio has adequately respect to control of the pollutant(s) that take appropriate steps to avoid a demonstrated maintenance of the PM 2.5 were contained in the SIP before violation if possible. Ohio commits to standard in this area for a period redesignation of the area to attainment. continue implementing SIP extending in excess of ten years from See section 175A(d) of the CAA. requirements upon and after expected final action on Ohio’s Ohio’s contingency measures include redesignation. redesignation request. a Warning Level Response and an Action Level Response. An initial EPA believes that Ohio’s contingency d. Monitoring Network Warning Level Response is triggered measures, as well as the commitment to Ohio’s plan includes a commitment to when the average weighted annual continue implementing any SIP continue working with West Virginia to mean for one year exceeds 15.5 mg/m3. requirements, satisfy the pertinent operate its EPA-approved monitoring A warning level response for the 2006 requirements of section 175A(d). network, as necessary to demonstrate 24-hour standard shall be prompted As required by section 175A(b) of the ongoing compliance with the NAAQS. whenever the 98th percentile 24-hour CAA, Ohio commits to submit to the 3 Ohio currently operates three PM2.5 PM2.5 concentration of 35.5 mg/m EPA an updated PM2.5 maintenance monitors in the Canton-Massillon area. occurs in a single calendar year within plan eight years after redesignation of West Virginia currently operates three the maintenance area. In that case, a the Canton-Massillon area to cover an monitors in their portion of the Canton- study will be conducted to determine if additional ten year period beyond the Massillon area. the emissions trends show increases; if initial ten year maintenance period. As required by section 175A of the CAA, e. Verification of Continued Attainment action is necessary to reverse emissions increases, Ohio will follow the same Ohio has also committed to retain the Ohio remains obligated to continue to procedures for control selection and PM2.5 control measures contained in the quality-assure monitoring data and enter implementation as for an Action Level SIP prior to redesignation. all data into AQS in accordance with Response. For all of the reasons set forth above, Federal guidelines. Ohio will use these The Action Level Response will be EPA is proposing to approve Ohio’s data, supplemented with additional prompted by any one of the following: 1997 annual and 2006 24-hour PM2.5 information as necessary, to assure that a Warning Level Response study that maintenance plan for the Canton- the area continues to attain the shows emissions increases, a weighted Massillon area as meeting the standard. Ohio will also continue to annual mean for the 1997 annual requirements of CAA section 175A. develop and submit periodic emission standard, or a 98th percentile for the 24- 5. Adequacy of Ohio’s MVEB inventories as required by the Federal hour standard, over a two-year period Consolidated Emissions Reporting Rule that exceeds the standard or a violation a. How are MVEBs developed and what (67 FR 39602, June 10, 2002) to track of the standard. If an Action Level are the MVEBs for the Canton-Massillon future levels of emissions. Both of these Response is triggered, Ohio will adopt area? actions will help to verify continued and implement appropriate control Under the CAA, states are required to attainment in accordance with 40 CFR measures within 12 months from the submit, at various times, control strategy part 58. end of the year in which monitored air SIP revisions and maintenance plans for quality triggering a response occurs. f. Contingency Plan PM nonattainment areas and for areas Ohio’s candidate contingency 2.5 The contingency plan provisions are seeking redesignations to attainment of measures include the following: designed to promptly correct or prevent i. Diesel emission reduction strategies; the PM2.5 standard. These emission a violation of the NAAQS that might ii. Alternative fuels; control strategy SIP revisions (e.g., RFP occur after redesignation of an area to and attainment demonstration SIP iii. Statewide NOX RACT rules; attainment. Section 175A of the CAA iv. Impact crushers at recycle scrap revisions) and maintenance plans create requires that a maintenance plan yards using wet suppression; MVEBs based on on-road mobile source include such contingency measures as v. Tighter emission offsets for new emissions for criteria pollutants and/or EPA deems necessary to assure that the and modified major sources; their precursors to address pollution state will promptly correct a violation of vi. ICI Boilers—SO2 and NOX from on-road transportation sources. the NAAQS that occurs after controls; The MVEBs are the portions of the total redesignation. The maintenance plan vii. Emission controls for: allowable emissions that are allocated to should identify the contingency a. Process heaters; highway and transit vehicle use that, measures to be adopted, a schedule and b. EGUS; together with emissions from other procedure for adoption and c. Internal combustion engines; sources in the area, will provide for implementation of the contingency d. Combustion turbines; attainment, RFP or maintenance, as measures, and a time limit for action by e. Other sources > 100 TPY; applicable.

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Under 40 CFR part 93, a MVEB for an The maintenance plan submitted by In the Canton-Massillon area, the area seeking a redesignation to Ohio for the Canton-Massillon area motor vehicle budgets including the attainment is established for the last contains new primary PM2.5 and NOX safety margins and motor vehicle year of the maintenance plan and could MVEBs for the area for the years 2015 emission projections for both NOX and also be established for an interim year and 2025. The motor vehicle emissions PM2.5 are lower than the levels in the or years. The MVEB serves as a ceiling budgets were calculated using attainment year. on emissions from an area’s planned MOVES2010(a). After the adequacy EPA has reviewed the submitted transportation system. The MVEB finding and approval of the budgets budgets for 2015 and 2025 including the concept is further explained in the become effective, the budgets will have added safety margins using the preamble to the November 24, 1993, to be used in future conformity conformity rule’s adequacy criteria transportation conformity rule (58 FR determinations and regional emissions found at 40 CFR 93.118(e)(4) and the 62188). analyses prepared by the SCATS, will conformity rule’s requirements for Under section 176(c) of the CAA, new have to be based on the use of safety margins found at 40 CFR transportation plans and transportation MOVES2010a or the most recent version 93.124(a). EPA has also completed a improvement programs (TIPs) must be of MOVES required to be used in thorough review of the maintenance evaluated to determine if they conform transportation conformity plan for the Canton-Massillon area. to the purpose of the area’s SIP. determinations.12 The state has Based on the results of this review of the Conformity to the SIP means that determined the 2015 MVEBs for the budgets and the maintenance plans, transportation activities will not cause Canton-Massillon area to be 204.33 tpy EPA is approving the 2015 and 2025 direct PM and NO budgets including new air quality violations, worsen for primary PM2.5 and 7,782.84 tpy for 2.5 X the requested safety margins for the existing air quality violations, or delay NOX. Ohio has determined the 2025 timely attainment of the NAAQS or any MVEBs for the Canton-Massillon area to Canton-Massillon area. Additionally, EPA, through this rulemaking, has required interim milestone. If a be 101.50 tpy for primary PM2.5 and found the submitted budgets to be transportation plan or TIP does not 4,673.83 tpy for NOX. These MVEBs conform, most new transportation exceed the on-road mobile source adequate for use to determine transportation conformity in the Canton- projects that would expand the capacity primary PM2.5 and NOX emissions of roadways cannot go forward. projected by the states for 2015 and Massillon area, because EPA has Regulations at 40 CFR part 93 set forth 2025. Ohio has decided to include determined that the area can maintain EPA policy, criteria, and procedures for ‘‘safety margins’’ as provided for in 40 the 1997 annual PM2.5 NAAQS for the demonstrating and assuring conformity CFR 93.124(a) (described below) of relevant maintenance period with on- of such transportation activities to a SIP. 26.65 tpy and 13.24 tpy for primary road mobile source emissions at the levels of the MVEBs including the When reviewing SIP revisions PM2.5 and 1,015.15 tpy and 609.63 tpy requested safety margins. These budgets containing MVEBs, including for NOX in the 2015 and 2025 MVEBs, must be used in conformity attainment strategies, rate-of-progress respectively, to provide for on-road determinations made on or after the plans, and maintenance plans, EPA mobile source growth. Ohio did not effective date of this direct final must affirmatively find adequate and/or provide emission budgets for SO2, rulemaking (40 CFR 93.118(f)(iii)). approve the MVEBs for use in VOCs, and ammonia because it Additionally, transportation conformity determining transportation conformity concluded, that emissions of these determinations made after the effective before the MVEBs can be used. Once precursors from on-road motor vehicles date of this notice must be based on EPA affirmatively approves and/or finds are not significant contributors to the regional emissions analyses using the submitted MVEBs to be adequate for area’s PM2.5 air quality problem. MOVES2010a or a more recent version transportation conformity purposes, the EPA issued conformity regulations to of MOVES that has been approved for MVEBs must be used by state and implement the 1997 PM2.5 NAAQS in use in conformity determinations.13 Federal agencies in determining July 2004 and May 2005 (69 FR 40004, whether proposed transportation plans July 1, 2004 and 70 FR 24280, May 6, b. What is a safety margin? and TIPs conform to the SIP as required 2005, respectively). Those actions were A ‘‘safety margin’’ is the difference by section 176(c) of the CAA. EPA’s not part of the final rule recently between the attainment level of substantive criteria for determining the remanded to EPA by the Court of emissions (from all sources) and the adequacy of MVEBs are set out in 40 Appeals for the District of Columbia in projected level of emissions (from all CFR 93.118(e)(4). Additionally, to NRDC v. EPA, No. 08–1250 (Jan. 4, sources) in the maintenance plan. As approve a motor vehicle emissions 2013), in which the Court remanded to shown in Table 4, the Canton-Massillon budget EPA must complete a thorough EPA the implementation rule for the area is projected to have safety margins review of the SIP, in this case the PM2.5 PM2.5 NAAQS because it concluded that for NOX and direct PM2.5 of 8,404.59 tpy maintenance plans, and conclude that EPA must implement that NAAQS and 344.19 tpy in 2025 (the difference the SIP will achieve its overall purpose, pursuant to the PM-specific between the attainment year, 2008, in this case providing for maintenance implementation provisions of subpart 4 emissions and the projected year of of the 1997 annual PM2.5 standard the of part D of title I of the CAA, rather 2025 emissions for all sources in the Canton-Massillon area. than solely under the general provisions Canton-Massillon area). The EPA’s process for determining of subpart 1. That decision does not transportation conformity rule allows adequacy of a MVEB consists of three affect EPA’s proposed approval of the areas to allocate all or a portion of a basic steps: (1) Providing public Canton-Massillon area MVEBs. ‘‘safety margin’’ to the area’s motor notification of a SIP submission; (2) providing the public the opportunity to 12 EPA described the circumstances under which 13 EPA described the circumstances under which comment on the MVEB during a public an area would be required to use MOVES in an area would be required to use MOVES in comment period; and, (3) EPA taking transportation conformity determinations in its transportation conformity determinations in its March 2, 2010, Federal Register notice officially March 2, 2010 Federal Register notice officially action on the MVEB. The process for releasing MOVES2010 for use in SIPs and releasing MOVES2010 for use in SIPs and determining the adequacy of submitted transportation conformity determinations. (75 FR transportation conformity determinations. (75 FR SIP MVEBs is codified at 40 CFR 93.118. 9413) 9413)

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vehicle emissions budgets (40 CFR Ohio submitted a 2005 inventory and a from Ohio to change the legal 92.124(a)). The MVEBs requested by 2008 base year emissions inventory that designation of the Canton-Massillon Ohio contain NOX safety margins for meets this requirement. Emissions area from nonattainment to attainment mobile sources in 2015 and 2025 and contained in the submittals cover the for the 1997 annual and 2006 24-hour PM2.5 safety margins for mobile sources general source categories of point PM2.5 NAAQS. EPA is proposing to in 2015 and 2025 are much smaller than sources, area sources, on-road mobile approve Ohio’s PM2.5 maintenance plan the allowable safety margins reflected in sources, and nonroad mobile sources. for the Canton-Massillon area as a the total emissions for the Canton- Further discussion on the methodology revision to the Ohio SIP because the Massillon area. The state is not of compiling the emissions inventories plan meets the requirements of section requesting allocation to the MVEBs of can be found in section V.3.b above, and 175A of the CAA. EPA is proposing to the entire available safety margins in the docket. Ohio’s supplemental approve the 2005 and 2008 emissions reflected in the demonstration of submittal of base year emission inventories for primary PM2.5, NOX, and maintenance. Therefore, even though inventories of VOCs and ammonia are SO2, documented in Ohio’s April 16, the state is requesting MVEBs that also found in the docket and 2012, submittal as satisfying the exceed the projected on-road mobile summarized in Table 6, below. requirement in section 172(c)(3) of the source emissions for 2015 and 2025 CAA for a comprehensive, current contained in the demonstration of TABLE 6—SUMMARY OF 2007 BASE emission inventory. Finally, EPA finds maintenance, the increase in on-road YEAR EMISSIONS OF AMMONIA AND adequate and is approving 2015 and mobile source emissions that can be VOCS FOR THE CANTON-MASSILLON 2025 primary PM2.5 and NOX MVEBs for the Canton-Massillon area. These considered for transportation AREA BY SOURCE TYPE conformity purposes is well within the MVEBs will be used in future [tpy] safety margins of the overall PM2.5 transportation conformity analyses for the area. maintenance demonstration. Ammonia VOC Therefore, EPA believes that the VI. What are the effects of EPA’s requested budgets, including the Point ...... 21.29 919.30 proposed actions? requested portion of the safety margins, Area ...... 1491.50 4825.67 provide for a quantity of mobile source Nonroad ...... 2.66 2723.36 If finalized, approval of the emissions that would be expected to On-road ...... 148.98 5199.46 redesignation request would change the official designation of the Canton- maintain the PM2.5 standard. Once allocated to mobile sources, these Total ...... 1666.11 13692.06 Massillon area for the 1997 annual and portions of the safety margins will not 2006 24-hour PM2.5 NAAQS, found at 40 All emissions discussed in Tables 2, be available for use by other sources. CFR part 81, from nonattainment to 3, and 6 above were documented in the attainment. If EPA’s proposal is c. What action is EPA taking on the docket and the appendices of Ohio’s finalized, this action would approve the submitted motor vehicle emissions redesignation request and supplemental maintenance plan for the 1997 annual budgets? submittals. EPA has reviewed Ohio’s and 2006 24-hour PM2.5 standards for EPA, through this rulemaking, has documentation of the emissions the Canton-Massillon area, as well as found adequate and is proposing to inventory techniques and data sources the 2005 and 2008 emissions approve the MVEBs for use to determine used for the derivation of the 2005, inventories included with the transportation conformity in the Canton- 2007, and 2008 emissions estimates, and redesignation request, as revisions to the Massillon area, because EPA has has found that Ohio has thoroughly Ohio SIP. determined that the area can maintain documented the derivation of these emissions inventories. The submittal VII. Statutory and Executive Order attainment of the 1997 annual PM2.5 Reviews NAAQS for the relevant maintenance from the state shows that the 2008 period with mobile source emissions at emissions inventory is currently the Under the CAA, redesignation of an the levels of the MVEBs including the most complete emissions inventories for area to attainment and the accompanying approval of a requested safety margins. These budgets PM2.5 and PM2.5 precursors in the must be used in conformity Canton-Massillon area. Based upon maintenance plan under section determinations if this rulemaking goes EPA’s review, we propose to find that 107(d)(3)(E) are actions that affect the final. (40 CFR 93.118(f)(iii)) the 2005 and 2007/2008 emissions status of a geographical area and do not Additionally, the determinations must inventories are as complete and accurate impose any additional regulatory be based on regional emissions analyses as possible given the input data requirements on sources beyond those using MOVES2010b or a more recent available to Ohio, and we are proposing imposed by state law. A redesignation to version of MOVES that has been to approve them under CAA section attainment does not in and of itself approved for use in conformity 172(c)(3). create any new requirements, but rather results in the applicability of determinations.14 7. Summary of Proposed Actions requirements contained in the CAA for 6. 2005 and 2008 Comprehensive EPA has previously determined that areas that have been redesignated to Emissions Inventory the Canton-Massillon area has attained attainment. Moreover, the Administrator As discussed above, section 172(c)(3) the 1997 annual and 2006 24-hour PM2.5 is required to approve a SIP submission of the CAA requires areas to submit a NAAQS. EPA is proposing to determine that complies with the provisions of the comprehensive emissions inventory. that the Canton-Massillon area Act and applicable Federal regulations. continues to attain the 1997 annual and 42 U.S.C. 7410(k); 40 CFR 52.02(a). 14 EPA described the circumstances under which 2006 24-hour PM2.5 standard using the Thus, in reviewing SIP submissions, an area would be required to use MOVES in latest three years of certified, quality- EPA’s role is to approve state choices, transportation conformity determinations in its assured data, and that the area has met provided that they meet the criteria of March 2, 2010, Federal Register notice officially the requirements for redesignation releasing MOVES2010 for use in SIPs and the CAA. Accordingly, this action transportation conformity determinations. (75 FR under section 107(d)(3)(E) of the CAA. merely approves state law as meeting 9413) EPA is proposing to approve the request Federal requirements and does not

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impose additional requirements beyond Dated: July 24, 2013. decision to vacate and remand to EPA those imposed by state law. For that Susan Hedman, the Cross-State Air Pollution Rule reason, these actions: Regional Administrator, Region 5. (CSAPR); and the Court’s January 4, • Are not a ’’significant regulatory [FR Doc. 2013–18951 Filed 8–6–13; 8:45 am] 2013, decision to remand to EPA two action’’ subject to review by the Office BILLING CODE 6560–50–P final rules implementing the 1997 PM2.5 of Management and Budget under standard. Executive Order 12866 (58 FR 51735, DATES: Comments must be received on October 4, 1993); ENVIRONMENTAL PROTECTION or before September 6, 2013. • Do not impose an information AGENCY ADDRESSES: Submit your comments, collection burden under the provisions 40 CFR Parts 52 and 81 identified by Docket ID No. EPA–R05– of the Paperwork Reduction Act (44 OAR–2010–0899, by one of the U.S.C. 3501 et seq.); [EPA–R05–OAR–2010–0899; FRL–9842–3] following methods: • Are certified as not having a • http://www.regulations.gov: Follow Approval and Promulgation of Air significant economic impact on a the on-line instructions for submitting Quality Implementation Plans; Illinois; substantial number of small entities comments. Redesignation of the Chicago Area to under the Regulatory Flexibility Act (5 • EMail: [email protected]. Attainment of the 1997 Annual Fine U.S.C. 601 et seq.); • Fax: (312) 408–2279. Particulate Matter Standard • • Do not contain any unfunded Mail: Douglas Aburano, Chief, mandate or significantly or uniquely AGENCY: Environmental Protection Attainment Planning and Maintenance affect small governments, as described Agency (EPA). Section, (AR–18J), U.S. Environmental in the Unfunded Mandates Reform Act ACTION: Proposed rule. Protection Agency, 77 West Jackson of 1995 (Pub. L. 104–4); Boulevard, Chicago, Illinois 60604. SUMMARY: EPA is proposing to grant a • Hand Delivery: Douglas Aburano, • Do not have Federalism redesignation request and State Chief, Attainment Planning and implications as specified in Executive Implementation Plan (SIP) revision Maintenance Section, Air Programs Order 13132 (64 FR 43255, August 10, request submitted by the state of Illinois Branch, (AR–18J), U.S. Environmental 1999); on October 15, 2010, and supplemented Protection Agency, 77 West Jackson • Are not economically significant on September 16, 2011, and May 6, Boulevard, 18th Floor, Chicago, Illinois regulatory actions based on health or 2013. The Illinois Environmental 60604. Such deliveries are only safety risks subject to Executive Order Protection Agency (IEPA) requested accepted during the Regional Office’s 13045 (62 FR 19885, April 23, 1997); EPA to redesignate the Illinois portion normal hours of operation, and special • Are not significant regulatory of the Chicago-Gary-Lake County, arrangements should be made for actions subject to Executive Order Illinois-Indiana (IL–IN) nonattainment deliveries of boxed information. The 13211 (66 FR 28355, May 22, 2001); area to attainment of the 1997 annual Regional Office official hours of • Are not subject to requirements of fine particulate matter (PM2.5) National business are Monday through Friday, Section 12(d) of the National Ambient Air Quality Standard (NAAQS 8:30 a.m. to 4:30 p.m., excluding Technology Transfer and Advancement or standard) and requested EPA Federal holidays. Act of 1995 (15 U.S.C. 272 note) because approval of Illinois’ PM2.5 maintenance Instructions: Direct your comments to application of those requirements would plan and PM2.5-related emission Docket ID No. EPA–R05–OAR–2010– be inconsistent with the CAA; and inventories for this area as revisions of 0899. EPA’s policy is that all comments • Do not provide EPA with the the Illinois SIP. The Illinois portion received will be included in the public discretionary authority to address, as (Chicago area) of this nonattainment docket without change and may be appropriate, disproportionate human area is: Cook, DuPage, Kane, Lake, made available online at health or environmental effects, using McHenry, and Will Counties, Aux Sable www.regulations.gov, including any practicable and legally permissible and Goose Lake Townships in Grundy personal information provided, unless methods, under Executive Order 12898 County, and Oswego Township in the comment includes information (59 FR 7629, February 16, 1994). Kendall County. EPA is proposing to claimed to be Confidential Business In addition, this rule does not have grant the state’s redesignation request Information (CBI) or other information tribal implications as specified by and to approve the requested Illinois whose disclosure is restricted by statute. Executive Order 13175 (65 FR 67249, SIP revisions, including the state’s plan Do not submit information that you November 9, 2000), because the SIP is for maintaining attainment of the 1997 consider to be CBI or otherwise not approved to apply in Indian country annual PM2.5 NAAQS in this area protected through www.regulations.gov located in the state, and EPA notes that through 2025. EPA is also proposing to or email. The www.regulations.gov Web it will not impose substantial direct approve Illinois’ 2008 and 2025 site is an ‘‘anonymous access’’ system, costs on tribal governments or preempt Nitrogen Oxides (NOX) and PM2.5 Motor which means EPA will not know your tribal law. Vehicle Emission Budgets (MVEBs) for identity or contact information unless the Chicago area. Finally, EPA is you provide it in the body of your List of Subjects proposing to approve Illinois’ 2002 comment. If you send an email 40 CFR Part 52 NOX, Sulfur Dioxide (SO2), Volatile comment directly to EPA without going Organic Compound, ammonia, and through www.regulations.gov, your Environmental protection, Air primary PM2.5 emission inventories for email address will be automatically pollution control, Incorporation by this area. In the context of this proposal captured and included as part of the reference, Intergovernmental relations, to redesignate the Chicago area, EPA comment that is placed in the public Particulate matter. addresses a number of additional issues, docket and made available on the Internet. If you submit an electronic 40 CFR Part 81 including the effects of two decisions of the United States Court of Appeals for comment, EPA recommends that you Air pollution control, Environmental the District of Columbia (D.C. Circuit or include your name and other contact protection, National Parks, Wilderness. Court): The Court’s August 21, 2012, information in the body of your

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comment and with any disk or CD–ROM b. Part D Requirements VI. Statutory and Executive Order Reviews you submit. If EPA cannot read your 2. The Chicago Area Has a Fully Approved Applicable SIP Under Section 110(k) of I. What should I consider as I prepare comment due to technical difficulties my comments for EPA? and cannot contact you for clarification, the CAA 3. Nonattainment Requirements EPA may not be able to consider your When submitting comments, 4. Effect of the January 4, 2013, D.C. Circuit remember to: comment. Electronic files should avoid Decision Regarding PM2.5 1. Identify the rulemaking by docket the use of special characters, any form Implementation Under Subpart 4 of the of encryption, and be free of any defects CAA number and other identifying and viruses. For additional instructions a. Background information (subject heading, Federal on submitting comments, go to section b. Proposal on This Issue Register date and page number). I of the SUPPLEMENTARY INFORMATION i. Applicable Requirements for Purposes of 2. Follow directions—EPA may ask section of this document. Evaluating the Redesignation Request you to respond to specific questions or Docket: All documents in the docket ii. Subpart 4 Requirements and Illinois’ organize comments by referencing a Redesignation Request are listed in the www.regulations.gov Code of Federal Regulations (CFR) part iii. Subpart 4 and Control of PM2.5 or section number. index. Although listed in the index, Precursors some information is not publicly C. Are the air quality improvements in the 3. Explain why you agree or disagree; available, e.g., CBI or other information Chicago-Gary-Lake County, IL–IN area suggest alternatives and substitute whose disclosure is restricted by statute. due to permanent and enforceable language for your requested changes. Certain other material, such as emission reductions? 4. Describe any assumptions and copyrighted material, will be publicly 1. Permanent and Enforceable Controls provide any technical information and/ available only in hard copy. Publicly a. Federal Emission Control Measures or data you used. i. Tier 2 Emission Standards for Vehicles available docket materials are available 5. If you estimate potential costs or and Gasoline Sulfur Standards burdens, explain how you arrived at either electronically in ii. Heavy-Duty Diesel Engine Rule www.regulations.gov or in hard copy at your estimate in sufficient detail to iii. Non-Road Diesel Engine Standards allow for it to be reproduced. the U.S. Environmental Protection iv. Non-Road Spark-Ignition Engines and Agency, Region 5, Air and Radiation Recreational Engine Standards 6. Provide specific examples to Division, 77 West Jackson Boulevard, b. Control Measures Statewide in Illinois illustrate your concerns, and suggest Chicago, Illinois 60604. This facility is and in Upwind Areas alternatives. 7. Explain your views as clearly as open from 8:30 a.m. to 4:30 p.m., i. NOX SIP Call possible, avoiding the use of profanity Monday through Friday, excluding ii. Clean Air Interstate Rule (CAIR) and Cross-State Air Pollution Rule (CSAPR) or personal threats. Federal holidays. We recommend that c. Consent Decrees 8. Make sure to submit your you telephone Edward Doty at (312) 2. Emission Reductions comments by the comment period 886–6057 before visiting the Region 5 a. Illinois’ Demonstration That Significant deadline identified in the proposed rule. office. Emission Reductions Have Occurred in FOR FURTHER INFORMATION CONTACT: the Chicago-Gary-Lake County, IL–IN II. What actions is EPA proposing? Edward Doty, Environmental Scientist, Area and in Upwind Areas b. VOC and Ammonia Emission EPA is proposing to take several Attainment Planning and Maintenance Reductions actions related to the redesignation of Section, Air Programs Branch (AR–18J), c. Conclusions Regarding Emission the Chicago area to attainment of the Environmental Protection Agency, Reductions Between 2002 and 2005 in 1997 annual PM2.5 NAAQS. EPA is Region 5, 77 West Jackson Boulevard, the Chicago Area proposing to determine that the Chicago, Illinois 60604, (312) 886–6057, D. Does Illinois have a fully approvable Chicago-Gary-Lake County, IL–IN area or [email protected]. PM2.5 maintenance plan pursuant to has attained the 1997 annual PM2.5 SUPPLEMENTARY INFORMATION: section 175A of the CAA for the Chicago NAAQS based on quality assured, Throughout this document, whenever area? certified 2007–2012 air quality data. 1. What is required in a maintenance plan? ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 2. Attainment Inventory EPA is proposing to grant the EPA. This supplementary information 3. Demonstration of Maintenance redesignation of the Chicago area to section is arranged as follows: 4. Monitoring Network attainment of the 1997 annual PM2.5 I. What should I consider as I prepare my 5. Verification of Continued Attainment NAAQS. comments for EPA? 6. Contingency Plan EPA proposes to find that Illinois’ II. What actions is EPA proposing? 7. Provision for Future Update of the PM2.5 maintenance plan meets the III. What is the background for these actions? Annual PM2.5 Maintenance Plan requirements of section 175A of the IV. What are the criteria for redesignation to 8. CAIR and CSAPR Clean Air Act (CAA) and is proposing a. Background—Effect of the August 21, attainment? to approve Illinois’ PM2.5 maintenance V. What is EPA’s analysis of the state’s 2012, D.C. Circuit Decision Regarding plan for the 1997 annual PM NAAQS EPA’s CSAPR 2.5 request? for the Chicago area as a revision to the A. Has the area achieved attainment of the b. Maintenance Plan Precursor Evaluation Illinois SIP. The PM2.5 maintenance 1997 annual PM2.5 standard? Resulting From Court Decisions B. Has the Chicago area and the State of E. Has Illinois adopted acceptable MVEBs plan provides for the maintenance of the Illinois met all applicable requirements for the PM2.5 maintenance period? 1997 annual PM2.5 NAAQS in the of section 110 and part D of the Clean 1. How are MVEBs developed and what are Chicago-Gary-Lake County, IL–IN area Air Act, and does the Chicago area have the MVEBs for the Chicago area? through 2025. The state of Illinois has a fully approved SIP under section 2. What are safety margins? committed to revising this maintenance 110(k) of the Clean Air Act for purposes F. Are the 2002 base year PM2.5-related plan to cover an additional 10 years of redesignation to attainment? emissions inventories for the Chicago within eight years after EPA approves 1. Illinois Has Met All Applicable area approvable under section 172(c)(3) Requirements for Purposes of of the CAA? the redesignation of the Chicago area to Redesignation of the Chicago Area Under 1. EPA’s Base Year Emissions Inventory attainment of the 1997 annual PM2.5 Section 110 and Part D of the Clean Air SIP Policy NAAQS. Act 2. 2002 Base Year PM2.5-Related Emission EPA is proposing to approve Illinois’ a. Section 110 General SIP Requirements Inventories for the Chicago Area 2008 and 2025 primary PM2.5 (fine

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particulates directly emitted by on-road percentile of the 24-hour PM2.5 development of a valid replacement.’’ motor vehicles) and NOX MVEBs for the concentrations. In response to legal EME Homer City at 38. The D.C. Circuit Chicago area. In addition, EPA is challenges of the 2006 annual PM2.5 denied all petitions for rehearing on proposing to find these MVEBs as standard, the U.S. Court of Appeals for January 24, 2013.2 In the second adequate for purposes of transportation the District of Columbia Circuit (D.C. decision, on January 4, 2013, in Natural and general conformity demonstrations Circuit) remanded this standard to EPA Resources Defense Council v. EPA, the and determinations. for further consideration. See American D.C. Circuit remanded to EPA the ‘‘Final Finally, EPA is proposing to approve Farm Bureau Federation and National Clean Air Fine Particle Implementation Illinois’ 2002 primary PM2.5, NOX, SO2, Pork Producers Council, et al. v. EPA, Rule’’ (72 FR 20586, April 25, 2007) and Volatile Organic Compound (VOC), and 559 F.3d 512 (D.C. Cir. 2009). Since the the ‘‘Implementation of the New Source ammonia emission inventories for the Chicago area is designated as Rule (NSR) Program for Particulate Chicago area as satisfying the nonattainment for the 1997 annual Matter Less than 2.5 Micrometers requirement of section 172(c)(3) of the PM2.5 standard, today’s proposed action (PM2.5)’’ final rule (73 FR 28321, May CAA for a current, accurate, and addresses redesignation of this area only 16, 2008). 706 F.3d 428 (D.C. Cir. 2013). comprehensive emission inventory. for the 1997 annual PM2.5 standard. On November 27, 2009, EPA made a IV. What are the criteria for III. What is the background for these final determination that the Chicago redesignation to attainment? actions? area had attained the 1997 annual PM2.5 The CAA sets forth the requirements Fine particulate pollution can be standard (76 FR 62243). This for redesignating a nonattainment area emitted directly from a source (primary determination of attainment for the 1997 to attainment of a NAAQS. Specifically, PM2.5) or formed secondarily through annual PM2.5 standard was based on section 107(d)(3)(E) of the CAA allows chemical reactions in the atmosphere quality-assured annual-averaged PM2.5 for redesignation provided that: (1) The 1 involving precursor pollutants emitted concentrations for PM2.5 monitoring Administrator determines that the area from a variety of sources. Sulfates are a sites in the Chicago-Gary-Lake County, has attained the applicable NAAQS type of secondary fine particulates IL–IN area for the period of 2006–2008. based on current air quality data; (2) the formed from reactions involving SO2 Based on our review of complete, Administrator has fully approved an emissions from power plants and quality-assured, and state-certified applicable SIP for the area under section industrial facilities. Nitrates, another ambient PM2.5 monitoring data from 110(k) of the CAA; (3) the Administrator common type of secondary particulate, 2009–2012 in the Chicago-Gary-Lake determines that the improvement in air are formed from combustion emissions County, IL–IN area, we are proposing to quality is due to permanent and of NOX (primarily Nitrogen Oxide (NO) determine that the Chicago area enforceable emission reductions and Nitrogen Dioxide (NO2)) from continues to attain the 1997 annual resulting from the implementation of power plants, mobile sources, and other PM2.5 NAAQS. the applicable SIP, Federal air pollution combustion sources. On October 15, 2010, IEPA submitted control regulations and other permanent EPA promulgated the first air quality a request to EPA for the redesignation of and enforceable emission reductions; (4) standards for PM2.5 on July 18, 1997, at the Chicago area to attainment of the the Administrator has fully approved a 62 FR 38652. In this rulemaking, EPA 1997 annual PM2.5 NAAQS and for EPA maintenance plan for the area meeting promulgated an annual standard at a approval of a SIP revision containing the requirements of section 175A of the level of 15 micrograms per cubic meter emission inventories and a maintenance CAA; and, (5) the state containing the (mg/m3) of ambient air, based on a three- plan for the area. The maintenance plan area has met all requirements applicable year average of the annual mean PM2.5 also includes 2008 and 2025 MVEBs for to the area for purposes of redesignation concentrations at each monitoring site the Chicago area. In a supplemental under section 110 and part D of the (the site’s PM2.5 design value for the submission to EPA on September 16, CAA. annual standard). In the same 2011, the IEPA revised the on-road rulemaking, EPA promulgated a 24-hour mobile source emissions and MVEBs in V. What is EPA’s analysis of the State’s 3 request? PM2.5 standard at a level of 65 mg/m , the original submittal to reflect the use based on a three-year average of the of EPA’s MOVES model to calculate A. Has the area achieved attainment of mobile source emissions. In a annual 98th percentile of 24-hour PM2.5 the 1997 annual PM2.5 standard? concentrations at each monitoring site. supplemental submission to EPA on On January 5, 2005, at 70 FR 944, EPA May 6, 2013, the IEPA submitted VOC In a final rulemaking dated November published air quality area designations and ammonia emission inventories to 27, 2009, at 76 FR 62243, EPA determined that the Chicago-Gary-Lake for the 1997 annual PM2.5 standard supplement the emission inventories based on air quality data for calendar that had previously been submitted to County, IL–IN area had attained the years 2001–2003. In that rulemaking, explain the attainment of the 1997 1997 annual PM2.5 standard. This determination was based on complete, EPA designated the Chicago-Gary-Lake annual PM2.5 standard in the Chicago- County, IL–IN area as nonattainment for Gary-Lake County, IL–IN area and to quality-assured monitoring data in this area for the calendar years of 2006– the 1997 annual PM2.5 standard. This demonstrate future maintenance of the area includes the Chicago area in PM2.5 standard in this area. 2008. In its September 16, 2011, Illinois and Lake and Porter Counties in In this proposed redesignation, EPA redesignation request, Illinois presents Indiana. takes into account two recent decisions On October 17, 2006, at 71 FR 61144, of the D.C. Circuit. In the first of the two Court decisions, the D.C. Circuit, on 2 On March 29, 2013, EPA and other parties filed EPA retained the annual PM2.5 standard petitions in the Supreme Court seeking certiorari of 3 August 21, 2012, issued EME Homer at 15 mg/m (2006 annual PM2.5 the D.C. Circuit’s decision in EME Homer City. On standard), but revised the 24-hour PM2.5 City Generation, L.P. v. EPA, 696 F.3d June 24, 2013, the Supreme Court consolidated the standard to 35 mg/m3, based again on the 7 (D.C. Cir. 2012), which vacated and petitions and granted certiorari. The Supreme remanded Cross-State Air Pollution Court’s decision to grant the petition is not a three-year average of the annual 98th decision on the merits but instead a decision to Rule (CSAPR) and ordered EPA to review the case on its merits. As such, it does not 1 Generally NOX, SO2, VOC, ammonia (NH3), and continue administering the Clean Air alter the current status of CAIR or CSAPR. At this primary PM2.5. Interstate Rule (CAIR) ‘‘pending . . . time, CAIR remains in place.

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quality-assured, state-certified PM2.5 Illinois and Indiana for 2010, 2011, and Table 1 provides a summary of the data for the period of 2007–2009. These 2012. Data recorded in EPA’s AQS show PM2.5 annual air quality data for the data show that the Chicago-Gary-Lake that the Chicago-Gary-Lake County, IL– Chicago-Gary-Lake County, IL–IN area County, IL–IN area attained the 1997 IN area initially attained the 1997 for the period of 2007–2012. These data annual PM2.5 standard through 2009. annual PM2.5 standard beginning in have been quality-assured and certified We have also obtained quality-assured 2005–2007, and this area has continued by the states of Illinois and Indiana. and state-certified data for the states of to attain this standard through 2012.3

TABLE 1—PM2.5 ANNUAL AVERAGE CONCENTRATIONS FOR THE CHICAGO-GARY-LAKE COUNTY, IL–IN PM2.5 NONATTAINMENT AREA (In μg/m3)

County Monitoring site 2007 2008 2009 2010 2011 2012

Illinois Monitoring Sites

Cook ...... Blue Island ...... 14.3 12.5 11.7 11.6 11.6 10.9 Cook ...... Chicago—Common- 14.3 11.9 11.1 12.3 11.3 11.3 wealth Edison. Cook ...... Chicago—Springfield 15.2 12.0 11.3 12.0 (2) 11.5 (2) 11.9 Cook ...... Chicago—Mayfair ..... 15.5 12.2 12.7 12.6 11.8 11.6 Cook ...... Chicago—SE Police 14.1 11.8 11.0 12.5 N/A N/A Cook ...... Chicago—Wash- 15.7 12.5 11.6 14.0 12.6 11.5 ington. Cook ...... Cicero ...... 14.8 13.3 (2) 12.8 (2) 11.9 11.4 10.4 Cook ...... Des Plaines ...... 12.7 11.4 11.0 10.6 10.6 10.9 Cook ...... McCook (1) ...... 15.6 12.9 12.6 12.6 12.6 12.6 Cook ...... Northbrook ...... 13.2 10.1 9.3 9.3 10.2 10.2 Cook ...... Schiller Park (1) ...... 15.4 13.6 (2) 12.9 12.6 13.3 13.1 Cook ...... Summit ...... 14.8 12.0 11.6 12.2 11.0 11.3 DuPage ...... Naperville ...... 13.8 11.3 9.8 11.7 10.5 10.1 Kane ...... Aurora ...... 13.2 10.3 10.0 11.3 9.8 10.0 Kane ...... Elgin ...... 14.5 10.8 9.8 11.4 10.8 9.9 Lake ...... Zion ...... 11.9 9.3 8.8 9.7 N/A N/A McHenry ...... Cary ...... 11.6 10.1 9.6 10.2 10.1 10.1 Will ...... Braidwood ...... 12.1 (2) 10.3 8.7 10.0 10.4 9.3 Will ...... Joliet ...... 14.6 11.7 10.5 11.8 10.2 11.1

Indiana Monitoring Sites

Lake ...... Franklin School ...... 14.4 12.0 11.3 12.5 11.4 10.7 Lake ...... Griffith ...... 13.2 11.7 11.0 12.4 11.2 N/A Lake ...... Madison Street ...... 14.6 12.3 12.1 12.9 12.1 11.5 Lake ...... Hammond—Purdue .. 13.8 11.7 15.9 12.3 11.4 10.6 Lake ...... Clark High School ..... 13.7 12.4 10.8 11.9 10.7 10.5 Porter ...... Ogden Dunes ...... 13.8 10.9 11.3 11.6 10.6 9.9

Notes: (1) Annual standard for PM2.5 does years do not meet data completeness 2007–2009, 2008–2010, 2009–2011, and not apply to these sites due to their proximity requirements (see a discussion of this issue 2010–2012 for each of the PM2.5 to industrial or roadway sources and lack of below). monitoring sites in the Chicago-Gary- representation of general population Table 2 gives the three-year averages Lake County, IL–IN PM2.5 exposure; and (2) the data for these sites and of the annual PM2.5 concentrations for nonattainment area.

TABLE 2—THREE-YEAR AVERAGES OF ANNUAL AVERAGE PM2.5 CONCENTRATIONS IN THE CHICAGO-GARY-LAKE COUNTY, IL–IN PM2.5 NONATTAINMENT AREA

County Monitoring site 2007–2009 2008–2010 2009–2011 2010–2012

Illinois Monitoring Sites

Cook ...... Blue Island ...... 12.8 11.9 11.6 11.4 Cook ...... Chicago—Commonwealth Edison ...... 12.4 11.8 11.6 11.6 Cook ...... Chicago—Springfield ...... 12.8 11.8 11.6 11.6 Cook ...... Chicago—Mayfair ...... 13.5 12.5 12.4 12.0 Cook ...... Chicago—SE Police ...... 12.3 11.8 N/A N/A Cook ...... Chicago—Washington ...... 13.3 12.7 12.7 12.7 Cook ...... Cicero ...... 13.1 12.7 12.0 11.2 Cook ...... Des Plaines ...... 11.7 11.0 10.7 10.7

3 Preliminary data for 2012 show that the Chicago-Gary-Lake County, IL–IN area continues to attain the 1997 annual PM2.5 standard through 2012.

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TABLE 2—THREE-YEAR AVERAGES OF ANNUAL AVERAGE PM2.5 CONCENTRATIONS IN THE CHICAGO-GARY-LAKE COUNTY, IL–IN PM2.5 NONATTAINMENT AREA—Continued

County Monitoring site 2007–2009 2008–2010 2009–2011 2010–2012

Cook ...... McCook ...... 13.7 12.7 12.6 12.6 Cook ...... Northbrook ...... 10.9 9.6 9.6 9.9 Cook ...... Schiller Park ...... 14.0 13.0 12.9 13.0 Cook ...... Summit ...... 12.8 11.9 11.6 11.5 DuPage ...... Naperville ...... 11.6 10.9 10.7 10.8 Kane ...... Aurora ...... 11.2 10.5 10.4 10.4 Kane ...... Elgin ...... 11.6 10.7 10.7 10.7 Lake ...... Zion ...... 10.0 9.3 N/A N/A McHenry ...... Cary ...... 10.4 10.0 10.0 10.1 Will ...... Braidwood ...... 10.4 9.7 9.7 9.9 Will ...... Joliet ...... 10.2 11.3 10.8 11.0

Indiana Monitoring Sites

Lake ...... Franklin School ...... 11.4 11.9 11.7 11.5 Lake ...... Griffith ...... 11.2 11.7 11.5 N/A Lake ...... Madison Street ...... 12.1 12.4 12.4 12.2 Lake ...... Hammond—Purdue ...... 11.4 13.3 13.2 11.4 Lake ...... Clark High School ...... 10.7 11.7 11.1 11.0 Porter ...... Ogden Dunes ...... 10.6 11.3 11.2 10.7

The data in tables 1 and 2 show that With regard to the McCook B. Has the Chicago area and the State all PM2.5 monitors in the Chicago-Gary- monitoring site, we agree with the IEPA of Illinois met all applicable Lake County, IL–IN area have recorded that this is a monitoring site that is requirements of section 110 and part D PM2.5 concentrations attaining the 1997 located near a localized industrial of the Clean Air Act, and does the annual PM2.5 standard during the most source and produces PM2.5 Chicago area have a fully approved SIP recent three years of quality-assured, concentrations that are not generally under section 110(k) of the Clean Air state-certified of PM2.5 data collection. representative of exposure for the Act for purposes of redesignation to As noted above, however, the PM2.5 data general populace on a long-term basis. attainment? for several sites in table 1 need further As such, in keeping with 40 CFR We are proposing to find that Illinois discussion. 58.30(a)(1), the annual mean PM2.5 has met all currently applicable SIP First, under 40 CFR 58.30(a)(1), for concentrations at this site should not be requirements for the purposes of monitoring sites with data that are compared to the 1997 annual PM2.5 representative of relatively unique, standard when judging the attainment redesignation of the Chicago area under generally localized concentrations, the status of the Chicago-Gary-Lake County, section 110 of the CAA (general SIP data are compared only to the 24-hour IL–IN area. In any case, this site also requirements). We are also proposing to find that the Illinois SIP meets all SIP PM2.5 NAAQS, and not to the annual shows annual mean PM2.5 requirements currently applicable for PM2.5 NAAQS. Illinois has two sites, concentrations that meet the 1997 purposes of redesignation under part D McCook and Schiller Park, that the IEPA annual PM2.5 standard. of title I of the CAA, in accordance with believes are not representative of EPA concludes that no violation of exposure for the general populace due section 107(d)(3)(E)(v) of the CAA. We the 1997 annual PM2.5 standard has to the proximity of these sites to are proposing to find that all applicable been recorded in the Chicago-Gary-Lake requirements of the Illinois SIP, for localized industrial or roadway sources. County, IL–IN area for any three-year EPA is not judging whether this purposes of redesignation, have been period during 2007–2012. For the implemented, in accordance with designation is appropriate. The reasons discussed above, EPA proposes applicable regulation, at 40 CFR section 107(d)(3)(E)(ii) of the CAA. As to determine that the Chicago-Gary-Lake 58.30(a)(2), recognizes that some discussed below, in this section, EPA is County, IL–IN area has attained the microscale sites collect data that are proposing to approve Illinois’ 2002 1997 annual PM2.5 standard. representative of multiple locations NOX, SO2, and PM2.5 emissions with localized high concentrations, and Illinois commits to continue inventory and 2007 VOC and ammonia provides in these cases that the data are monitoring PM2.5 in the Chicago area emissions inventory as meeting the appropriate for comparison to the according to an EPA-approved section 172(C)(3) requirement for a annual PM2.5 standard. The Schiller monitoring plan, as required to confirm comprehensive emissions inventory. Park site is near a major highway, and and assure maintenance of the 1997 In making these proposed the site may be representative of annual PM2.5 standard in this area. If determinations, we have ascertained multiple locations in the Chicago area changes in the PM2.5 monitoring system which SIP requirements are applicable that have similar proximity to major become necessary, IEPA will work with for purposes of redesignation, and have highways. For this reason, Table 1 above EPA to ensure the continued adequacy concluded that there are SIP measures includes annual mean PM2.5 of the monitoring system. Illinois will meeting these requirements and that concentrations for this site. In any case, continue to quality-assure the they are approved or will be approved

this site shows annual mean PM2.5 monitoring data to meet the by the time of final rulemaking on the concentrations that meet the 1997 requirements of 40 CFR part 58. State’s PM2.5 redesignation request. annual PM2.5 standard.

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1. Illinois Has Met All Applicable redesignated to attainment. We 172(c)(1)–(9) of the CAA. A thorough Requirements for Purposes of conclude that only the section 110 and discussion of the requirements Redesignation of the Chicago Area part D requirements that are linked with contained in section 172 can be found Under Section 110 and Part D of the an area’s designation and classification in the General Preamble for Clean Air Act are the relevant measures which we Implementation of title I (57 FR 13498, a. Section 110 General SIP must consider in evaluating a April 16, 1992). Section 172(c)(1) requires the state Requirements redesignation request. This approach is consistent with EPA’s policy on plans for all nonattainment areas to Section 110(a) of title I of the CAA applicability of conformity and provide for the implementation of contains the general requirements for a oxygenated fuels requirements for Reasonably Available Control Measures SIP. Section 110(a)(2) provides that the redesignation purposes, as well as with (RACM) as expeditiously as practicable. implementation plan submitted by a section 184 ozone transport EPA interprets this requirement to state must have been adopted by the requirements. See Reading, impose a duty on all states with state after reasonable public notice and Pennsylvania, proposed and final nonattainment areas to consider all hearing, and, among other things, must: rulemakings (61 FR 53174–53176, available control measures and to adopt (1) Include enforceable emission October 10, 1996) and (62 FR 24826, and implement such measures as are limitations and other control measures, May 7, 1997); Cleveland-Akron-Lorain, reasonably available for implementation means or techniques necessary to meet Ohio, final rulemaking (61 FR 20458, in these areas as components of the the requirements of the CAA; (2) May 7, 1996); and Tampa, Florida, final areas’ attainment demonstrations (the provide for establishment and operation rulemaking (60 FR 62748, December 7, attainment demonstrations must address of appropriate devices, methods, 1995). See also the discussion of this RACM). Because attainment of the 1997 systems and procedures necessary to issue in the Cincinnati, Ohio 1-hour annual PM2.5 NAAQS has been achieved monitor ambient air quality; (3) provide ozone redesignation (65 FR 3780, June in the Chicago-Gary-Lake County, IL–IN for implementation of a source permit 19, 2000), and in the Pittsburgh, area, no additional RACM measures are program to regulate the modification Pennsylvania 1-hour ozone needed to provide for attainment, and and construction of any stationary redesignation (66 FR 50399, October 19, the section 172(c)(1) requirements are source within the areas covered by the 2001). no longer considered to be applicable as plan; (4) include provisions for the We have reviewed the Illinois SIP and a prerequisite for approval of Illinois’ implementation of part C, Prevention of have concluded that it meets the general redesignation request, provided the area Significant Deterioration (PSD) and part SIP requirements under section 110 of continues to attain the standard until D, New Source Review (NSR) permit the CAA to the extent they are the redesignation of the Chicago area programs; (5) include criteria for applicable to the state’s request for occurs. See 40 CFR 51.1004(c). stationary source emission control redesignation. EPA has previously Section 172(c)(2) requires plans for all measures, monitoring and reporting; (6) approved provisions of the Illinois SIP nonattainment areas to provide for include provisions for air quality addressing section 110 requirements, reasonable further progress (RFP) modeling; and (7) provide for public including provisions addressing toward attainment of the NAAQS. This and local agency participation in particulate matter, at 40 CFR 52.720. In requirement is not relevant for purposes planning and emission control rule a submittal dated December 12, 2007, of redesignation because the Chicago- development. Illinois addressed infrastructure SIP Gary-Lake County, IL–IN area has Section 110(a)(2)(D) of the CAA elements required under section monitored attainment of the 1997 requires that SIPs contain measures to 110(a)(2) of the CAA for PM under the annual PM2.5 NAAQS (General prevent sources in a state from 2.5 1997 annual PM2.5 standard. EPA Preamble, 57 FR 13564). See also 40 significantly contributing to air quality approved this submittal on August 12, CFR 51.1009. In addition, because the problems in another state. However, the 2011, at 76 FR 41075. The requirements Chicago-Gary-Lake County, IL–IN area section 110(a)(2)(D) SIP requirements of section 110(a)(2), however, are has attained the 1997 annual PM2.5 are not linked with a particular area’s statewide SIP requirements that are not NAAQS, the requirement for RFP under designation and classification. EPA linked to the PM2.5 nonattainment status section 172(c)(2), as well as the believes that the requirements linked of the Chicago area. Therefore, EPA requirement for contingency measures with an area’s designation and believes that these infrastructure under section 172(c)(9), is not classification are the relevant measures elements are not applicable applicable for purposes of to evaluate in reviewing a redesignation requirements for purposes of review of redesignation. Id. request. The section 110(a)(2)(D) the state’s PM redesignation request. Section 172(c)(3) requires submission requirements, where applicable, 2.5 and EPA approval of a comprehensive, continue to apply to a state regardless of b. Part D Requirements accurate and current inventory of actual the designation of any one particular EPA has determined that, if EPA emissions. Illinois submitted a 2002 area in the state. Thus, we believe that approves the base year emissions base year emissions inventory for these requirements are not applicable inventories, discussed in section V.F primary PM2.5, NOX, and SO2 in June requirements for purposes of below, the Illinois SIP will meet the SIP 2006, and documented this emissions redesignation. requirements applicable for purposes of inventory in a June 2006 publication Further, we believe that section redesignation under part D of the CAA titled ‘‘Illinois Base Year Particulate 110(a)(2) elements other than those for the Chicago area. Matter and Haze Inventory for 2002’’. As described above that are not connected Subpart 1 of part D, found in sections discussed below in section V.F, EPA is with nonattainment plan submissions 172–176 of the CAA, sets forth the basic proposing to approve Illinois’ 2002 base and that are not linked with an area’s nonattainment requirements applicable year emission inventories as meeting the attainment status are also not applicable for nonattainment areas. section 172(c)(3) emission inventory requirements for purposes of requirement for the Chicago area. redesignation. A state remains subject to Subpart 1 Section 172 Requirements Section 172(c)(4) requires the these requirements regardless of an The applicable subpart 1 identification and quantification of area’s designation and after the area is requirements are contained in sections emissions for major new and modified

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stationary sources to be allowed in an Subpart 1 Section 176(c)(4)(D) approval and effective date of EPA’s area, and section 172(c)(5) requires Conformity SIP Requirements approval of the redesignation of the source permits for the construction and Section 176(c) of the CAA requires Chicago area to attainment of the 1997 operation of new and modified major states to establish criteria and annual PM2.5 standard. stationary sources in the nonattainment procedures to ensure that Federally- 2. The Chicago Area Has a Fully area. EPA approved Illinois NSR supported or funded activities including Approved Applicable SIP Under Section program 4 on December 17, 1992 (57 FR highway projects, conform to the air 110(k) of the CAA 59928), September 27, 1995 (60 FR quality planning goals of the SIPs. The 49780), and May 13, 2003 (68 FR Upon final approval of Illinois’s requirement to determine conformity comprehensive 2002 emissions 25504). Further, EPA has determined applies to transportation plans, 5 inventories, EPA will have fully that, since PSD requirements will programs and projects developed, apply after redesignation, the Chicago approved the Illinois SIP for the Chicago funded or approved under title 23 of the area under section 110(k) of the CAA for area and the state of Illinois need not U.S. Code and the Federal Transit Act comply with the requirement that a NSR all requirements applicable for purposes (transportation conformity), as well as to program be approved prior to of redesignation to attainment for the all other federally-supported or funded redesignation, provided that the state 1997 annual PM2.5 NAAQS. EPA may projects (general conformity). State demonstrates maintenance of the rely on prior SIP approvals when conformity SIP revisions must be NAAQS without implementation of part rulemaking on a redesignation request consistent with Federal conformity D NSR. A more detailed rationale for (See page 3 of the September 4, 1992, regulations relating to consultation, this view is described in a John Calcagni memorandum titled enforcement and enforceability, which memorandum from Mary Nichols, ‘‘Procedures for Processing Requests to EPA promulgated pursuant to CAA Assistant Administrator for Air and Redesignate Areas to Attainment’’ requirements. Radiation, dated October 14, 1994, (Calcagni memorandum); Southwestern EPA believes that it is reasonable to titled, ‘‘Part D New Source Review Pennsylvania Growth Alliance v. interpret the conformity SIP Requirements for Areas Requesting Browner, 144 F.3d 984, 989–990 (6th requirements as not applying for Redesignation to Attainment’’ (Nichols Cir. 1998); Wall v. EPA, 265 F.3d 426 purposes of evaluating the redesignation memorandum). Illinois has (6th Cir. 2001)), plus any additional request under section 107(d) for two demonstrated that the Chicago-Gary- measures it may approve in conjunction reasons. First, the requirement to submit Lake County, IL–IN area will be able to with a redesignation action. See 68 Fr SIP revisions to comply with the maintain the 1997 annual PM2.5 25413, 25426 (May 12, 2003). standard without the continued conformity provisions of the CAA Since the passage of the CAA in 1970, implementation of the state’s part D continues to apply to areas after Illinois has adopted and submitted, and NSR program. Therefore, EPA concludes redesignation to attainment since such EPA has fully approved, SIP provisions that Illinois need not have a fully areas would be subject to section 175A addressing various required SIP approved part D NSR program as an maintenance plans. Second, EPA’s elements under the particulate matter applicable requirement for approval of Federal conformity rules require the standards. In this action, EPA is the state’s redesignation request. The performance of conformity analyses in proposing to approve Illinois’s 2002 state’s PSD program will become the absence of Federally-approved state base year emissions inventories for the effective in the Chicago area upon rules. Therefore, because areas are Chicago area as meeting the requirement redesignation to attainment of the 1997 subject to the conformity requirements of section 172(c)(3) of the CAA for the regardless of whether they are PM2.5 standard. See redesignation 1997 annual PM2.5 standard. redesignated to attainment and, because rulemakings for Detroit, Michigan (60 3. Nonattainment Requirements FR 12467–12468, March 7, 1995); they must implement conformity under Cleveland-Akron-Lorain, Ohio (61 FR Federal rules if state rules are not yet No Illinois SIP provision applicable 20458, 20469–20470, May 7, 1996); approved, EPA believes it is reasonable for redesignation of the Chicago area is Louisville, Kentucky (66 FR 53665, to view these requirements as not currently disapproved, conditionally October 23, 2001); and, Grand Rapids, applying for purposes of evaluating a approved or partially approved. Michigan (61 FR 31834–31837, June 21, redesignation request. See Wall v. EPA, 4. Effect of the January 4, 2013, D.C. 265 F.3d 426 (6th Cir. 2001), upholding 1996). Circuit Decision Regarding PM2.5 Section 172(c)(6) requires the SIP to this interpretation. See also 60 FR Implementation Under Subpart 4 of the contain emission control measures 62748, 62749–62750 (December 7, 1995) CAA necessary to provide for attainment of (Tampa, Florida). a. Background the standard. Because attainment has EPA approved Illinois’ general been reached in the Chicago area, no conformity SIP on December 23, 1997 As discussed above, on January 4, additional measures are needed to (62 FR 67000). Illinois does not have a 2013, in Natural Resources Defense provide for attainment of the standard. Federally-approved transportation Council v. EPA, the D.C. Circuit Section 172(c)(7) requires the SIP to conformity SIP. However, Illinois remanded to EPA the ‘‘Final Clean Air meet the applicable provisions of performs conformity analyses pursuant Fine Particle Implementation Rule’’ (72 section 110(a)(2). As noted above, in to EPA’s Federal conformity rules. FR 20586, April 25, 2007) and the section V.B.1.a, we conclude that the Illinois has submitted on-road mobile ‘‘Implementation of the New Source Illinois SIP meets the requirements of source emission budgets for the Chicago Review (NSR) Program for Particulate section 110(a)(2) applicable for purposes area of 5,100 tons per year (TPY) of Matter Less than 2.5 Micrometers of redesignation. primary PM2.5 and 127,951 TPY of NOX (PM2.5)’’ final rule (73 FR 28321, May for 2008 and 2,377 TPY of primary 16, 2008) (collectively, ‘‘1997 PM2.5 4 The NSR program controls the growth and PM2.5 and 44,224 TPY of NOX for 2025, Implementation Rule’’). 706 F.3d 428 permitting of major source emissions in respectively. Illinois must use these (D.C. Cir. 2013). The Court found that nonattainment areas. MVEBs in any conformity determination EPA erred in implementing the 1997 5 PSD requirements control the growth of new source emissions in areas designated as attainment that is effective on or after the effective PM2.5 NAAQS pursuant to the general for a NAAQS. date of the PM2.5 maintenance plan implementation provisions of subpart 1

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of part D of title I of the CAA, rather ‘‘applicable’’ and which must be that had been due at the time the than to the particulate matter-specific approved in order for EPA to redesignation request was submitted. provisions of subpart 4 of part D of title redesignate an area include only those See, e.g., Proposed Redesignation of I. which came due prior to a state’s Manitowoc County and Door County submittal of a complete redesignation Nonattainment Areas (75 FR 22047, b. Proposal on This Issue request. See Calcagni memorandum. See 22050, April 27, 2010). In those actions, In this portion of the redesignation also ‘‘State Implementation Plan (SIP) EPA, therefore, did not consider subpart proposed rule, EPA addresses the effect Requirements for Areas Submitting 2 requirements to be ‘‘applicable’’ for of the Court’s January 4, 2013 ruling on Requests for Redesignation to the purposes of evaluating whether the the proposed redesignation. As Attainment of the Ozone and Carbon area should be redesignated under explained below, EPA is proposing to Monoxide (CO) National Ambient Air section 107(d)(3)(E). determine that the Court’s January 4, Quality Standards (NAAQS) on or after EPA’s interpretation derives from the 2013, decision does not prevent EPA November 15, 1992,’’ Memorandum provisions of CAA Section 107(d)(3). from redesignating the Chicago area to from Michael Shapiro, Acting Assistant Section 107(d)(3)(E)(v) states that, for an attainment. Even in light of the Court’s Administrator, Air and Radiation, area to be redesignated, a state must decision, redesignation for this area is September 17, 1993 (Shapiro meet ‘‘all requirements ‘applicable’ to appropriate under the CAA and EPA’s memorandum); Final Redesignation of the area under section 110 and part D’’. longstanding interpretations of the Detroit-Ann Arbor, (60 FR 12459, Section 107(d)(3)(E)(ii) provides that the CAA’s provisions regarding 12465–66, March 7, 1995); Final EPA must have fully approved the redesignation. EPA first explains its Redesignation of St. Louis, Missouri, (68 ‘‘applicable’’ SIP for the area seeking longstanding interpretation that FR 25418, 25424–27, May 12, 2003); redesignation. These two sections read requirements that are imposed, or that Sierra Club v. EPA, 375 F.3d 537, 541 together support EPA’s interpretation of become due, after a complete (7th Cir. 2004) (upholding EPA’s ‘‘applicable’’ as only those requirements redesignation request is submitted for redesignation rulemaking applying this that came due prior to submission of a an area that is attaining the standard, are interpretation and expressly rejecting complete redesignation request. First, not applicable for purposes of Sierra Club’s view that the meaning of holding states to an ongoing obligation evaluating a redesignation request. ‘‘applicable’’ under the statute is to adopt new CAA requirements that Second, EPA then shows that, even if ‘‘whatever should have been in the plan arise after the states submit their EPA applies the subpart 4 requirements at the time of attainment rather than redesignation requests, in order to be to Illinois’ redesignation request and whatever actually was in the plan and redesignated, would make it disregards the provisions of its 1997 already implemented or due at the time problematic or impossible for EPA to act PM2.5 implementation rule recently of attainment’’).6 In this case, at the time on redesignation requests in accordance remanded by the Court, the state’s that Illinois submitted its redesignation with the 18-month deadline Congress request for redesignation of this area request, requirements under subpart 4 set for EPA action in section still qualifies for approval. EPA’s were not due, and indeed, were not yet 107(d)(3)(D). If ‘‘applicable discussion takes into account the effect known to apply. requirements’’ were interpreted to be a of the Court’s ruling on the Chicago EPA’s view that, for purposes of continuing flow of requirements with no area’s maintenance plan, which EPA evaluating the Chicago area reasonable limitation, states, after views as approvable when subpart 4 redesignation, the subpart 4 submitting redesignation requests, requirements are considered. requirements were not due at the time would be forced continuously to make i. Applicable Requirements for Purposes the state submitted the redesignation additional SIP submissions that in turn of Evaluating the Redesignation Request request is in keeping with the EPA’s would require EPA to undertake further interpretation of subpart 2 requirements notice-and-comment rulemaking actions With respect to the 1997 PM2.5 for subpart 1 ozone nonattainment areas to act on those submissions. This would Implementation Rule, the Court’s redesignated subsequent to the D.C. create a regime of unceasing rulemaking January 4, 2013, ruling rejected EPA’s Circuit’s decision in South Coast Air that would delay action on the reasons for implementing the PM2.5 Quality Mgmt. Dist. v. EPA, 472 F.3d redesignation requests beyond the 18- NAAQS solely in accordance with the 882 (D.C. Cir. 2006). In South Coast, the month timeframe provided by the Act provisions of subpart 1, and remanded Court found that EPA was not permitted for this purpose. that matter to EPA, so that it could to implement the 1997 8-hour ozone Second, a fundamental premise for address implementation of the 1997 standard solely under subpart 1, and redesignating a nonattainment area to PM2.5 NAAQS under subpart 4 of part D held that EPA was required under the attainment is that the area has attained of the CAA, in addition to subpart 1. For statute to implement the standard under the relevant NAAQS due to emission the purposes of evaluating Illinois’ the ozone-specific requirements of reductions from existing controls. Thus, redesignation request for the Chicago subpart 2 as well. Subsequent to the an area, for which a redesignation area, to the extent that implementation South Coast decision, in evaluating and request has been submitted, would have under subpart 4 would impose acting upon redesignation requests for already attained the NAAQS as a result additional requirements for areas the 1997 8-hour ozone standard that of satisfying statutory requirements that designated nonattainment, EPA believes were submitted to EPA for areas under came due prior to the submission of the that those requirements are not subpart 1, EPA applied its longstanding request. Absent a showing that ‘‘applicable’’ for the purposes of CAA interpretation of the CAA that unadopted and unimplemented section 107(d)(3)(E), and, thus, EPA is ‘‘applicable requirements’’, for purposes requirements are necessary for future not required to consider subpart 4 of evaluating a redesignation, are those maintenance, it is reasonable to view requirements with respect to the the requirements applicable for Chicago area redesignation. Under its 6 Applicable requirements of the CAA that come purposes of evaluating the redesignation longstanding interpretation of the CAA, due subsequent to the area’s submittal of a complete request as including only those SIP EPA has interpreted section 107(d)(3)(E) redesignation request remain applicable until a requirements that have already come redesignation is approved, but are not required as to mean, as a threshold matter, that the a prerequisite to redesignation. Section 175A(c) of due. These are the requirements that led part D provisions which are the CAA. to attainment of the NAAQS. To require,

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for redesignation approval, that a state 4 requirements, of which it had no nonattainment area. Under section 188 also satisfy additional SIP requirements notice, would inflict the same of the CAA, all areas designated as coming due after the state submits its unfairness condemned by the Court in nonattainment areas under subpart 4 complete redesignation request, and Sierra Club v. Whitman. would initially be classified by while EPA is reviewing it, would operation of law as ‘‘moderate’’ ii. Subpart 4 Requirements and Illinois’ compel the state to do more than is Redesignation Request nonattainment areas, and would remain necessary to attain the NAAQS, without as moderate nonattainment areas unless a showing that the additional Even if EPA were to take the view that and until EPA reclassifies the areas as requirements are necessary for the Court’s January 4, 2013, decision ‘‘serious’’ nonattainment areas. maintenance. requires that, in the context of pending Accordingly, EPA believes that it is In the context of this redesignation, redesignations, subpart 4 requirements appropriate to limit the evaluation of the timing and nature of the Court’s were due and in effect at the time the the potential impacts of subpart 4 January 4, 2013, decision in NRDC v. state submitted its redesignation requirements to those that would be EPA compound the consequences of request, EPA proposes to determine that applicable to moderate nonattainment imposing requirements that come due the Chicago area still qualifies for areas. Sections 189(a) and (c) of subpart after the redesignation request is redesignation to attainment. As 4 apply to moderate nonattainment submitted. The state submitted its explained below, EPA believes that the areas and include the following: (1) an redesignation request on October 15, redesignation request for the Chicago approved permit program for 2010, but the Court did not issue its area, though not expressed in terms of construction of new and modified major subpart 4 requirements, substantively decision remanding EPA’s 1997 PM2.5 stationary sources (section 189(a)(1)(A)); Implementation Rule concerning the meets the requirements of that subpart (2) an attainment demonstration (section applicability of the provisions of for purposes of redesignating the area to 189(a)(1)(B)); (3) provisions for RACM subpart 4 until January 2013. attainment. (section 189(a)(1)(C)); and (4) With respect to evaluating the To require the state’s fully-completed quantitative milestones demonstrating relevant substantive requirements of and pending redesignation request to RFP toward attainment by the subpart 4 for purposes of redesignating comply now with requirements of applicable attainment date (section the Chicago area, EPA notes that subpart subpart 4 that the Court announced only 189(c)). 4 incorporates components of subpart 1 in January 2013, would be to give The permit requirements of subpart 4, of part D, which contain general air retroactive effect to such requirements as contained in section 189(a)(1)(A), quality planning requirements for areas when the state had no notice that it was refer to and apply the subpart 1 permit designated as nonattainment. See required to meet them. The D.C. Circuit provisions requirements of sections 172 Section 172(c). Subpart 4, itself, recognized the inequity of this type of and 173 to PM , without adding to contains specific planning and 10 retroactive impact in Sierra Club v. them. Consequently, EPA believes that scheduling requirements for PM 8 Whitman, 285 F.3d 63 (D.C. Cir. 2002),7 10 section 189(a)(1)(A) does not itself nonattainment areas, and under the where it upheld the District Court’s impose, for redesignation purposes, any Court’s January 4, 2013, decision in ruling refusing to make retroactive additional requirements for moderate NRDC v. EPA, these same statutory EPA’s determination that the St. Louis areas beyond those contained in subpart requirements also apply for PM area did not meet its attainment 2.5 1.9 In any event, in the context of nonattainment areas. EPA has deadline. In that case, petitioners urged redesignation, EPA has long relied on longstanding general guidance that the Court to make EPA’s nonattainment the interpretation that a fully approved interprets the 1990 amendments to the determination effective as of the date nonattainment NSR program is not CAA, making recommendations to states that the statute required, rather than the considered an applicable requirement for meeting the statutory requirements later date on which EPA actually made for redesignation, provided that the area for SIPs for nonattainment areas. See, the determination. The Court rejected can maintain the standard with a PSD ‘‘State Implementation Plans; General this view, stating that applying it program after redesignation. A detailed Preamble for the Implementation of ‘‘would likely impose large costs on rationale for this view is described in Title I of the Clear Air Act Amendments States, which would face fines and suits the Nichols memorandum. See also of 1990,’’ 57 FR 13498 (April 16, 1992) for not implementing air pollution rulemakings for Detroit, Michigan (60 (the ‘‘General Preamble’’). In the General prevention plans . . . even though they FR 12467–12468, March 7, 1995); Preamble, EPA discussed the were not on notice at the time.’’ Id. at Cleveland-Akron-Lorain, Ohio (61 FR relationship of subpart 1 and subpart 4 68. Similarly, it would be unreasonable 20458, 20469–20470, May 7, 1996); SIP requirements, and pointed out that to penalize the state of Illinois by Louisville, Kentucky (66 FR 53665, subpart 1 requirements were to an rejecting its redesignation request for an October 23, 2001); and Grand Rapids, extent ‘‘subsumed by, or integrally area that is already attaining the 1997 Michigan (61 FR 31834–31837, June 21, related to, the more specific PM–10 PM2.5 standard and that met all 1996). requirements.’’ 57 FR 13538 (April 16, applicable requirements known to be in With respect to the specific 1992). The subpart 1 requirements effect at the time of the redesignation attainment planning requirements under include, among other things, provisions request. For EPA now to reject the subpart 4,10 when EPA evaluates a for attainment demonstrations, RACM, redesignation request solely because the redesignation request under either RFP, emissions inventories, and state did not expressly address subpart subpart 1 and/or subpart 4, any area that contingency measures. is attaining the PM2.5 standard is viewed 7 Sierra Club v. Whitman was discussed and For the purposes of this redesignation, in order to identify additional as having satisfied the attainment distinguished in a recent D.C. Circuit decision that planning requirements for these addressed retroactivity in a quite different context, requirements which would apply under where, unlike the situation here, EPA sought to give subpart 4, we are considering the its regulations retroactive effect. National 9 The potential effect of section 189(e) on section Petrochemical and Refiners Ass’n v. EPA. 630 F.3d Chicago area to be a ‘‘moderate’’ PM2.5 189(a)(1)(A) for purposes of evaluating this 145, 163 (D.C. Cir. 2010), rehearing denied 643 F.3d redesignation request is discussed below. 8 10 958 (D.C. Cir. 2011), cert denied 132 S. Ct. 571 PM10 refers to particulates nominally 10 I.e., attainment demonstration, RFP, RACM, (2011). micrometers in diameter or smaller. milestone requirements, and contingency measures.

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subparts. For redesignations, EPA has, governed by the requirements of subpart Specifically, in 40 CFR 51.1002, EPA for many years, interpreted attainment- 4, explain EPA’s reasoning. They provided, among other things, that a linked requirements as not applicable describe the effects of a determination of state was ‘‘not required to address VOC for areas attaining the standard. In the attainment on the attainment-related SIP [and ammonia] as . . . PM2.5 attainment General Preamble, EPA stated that: planning requirements of subpart 4. See plan precursor[s] and to evaluate The requirements for RFP will not apply in ‘‘Determination of Attainment for Coso sources of VOC [and ammonia] evaluating a request for redesignation to Junction Nonattainment Area,’’ (75 FR emissions in the State for control attainment since, at a minimum, the air 27944, May 19, 2010). See also Coso measures.’’ EPA intended these to be quality data for the area must show that the Junction proposed PM10 redesignation, rebuttable presumptions. EPA area has already attained. Showing that the (75 FR 36023, 36027, June 24, 2010); established these presumptions at the State will make RFP towards attainment will, Proposed and Final Determinations of time because of uncertainties regarding ‘therefore, have no meaning at that point. Attainment for San Joaquin the emission inventories for these ‘‘General Preamble for the Interpretation Nonattainment Area (71 FR 40952, pollutants and the effectiveness of of Title I of the Clean Air Act 40954–55, July 19, 2006; and 71 FR specific control measures in various Amendments of 1990’’; (57 FR 13498, 63641, 63643–47 October 30, 2006). In regions of the country in reducing PM2.5 13564, April 16, 1992). The General short, EPA in this context, has also long concentrations. EPA also left open the Preamble also explained that: concluded that to require states to meet possibility for such regulation of VOC [t]he section 172(c)(9) requirements are superfluous SIP planning requirements and ammonia in specific areas where directed at ensuring RFP and attainment by is not necessary and not required by the that was necessary. the applicable date. These requirements no CAA, so long as those areas continue to The Court, in its January 4, 2013, longer apply when an area has attained the attain the relevant NAAQS. decision, made reference to both section standard and is eligible for redesignation. Elsewhere in this notice, EPA 189(e) and 40 CFR 51. 1002, and stated Furthermore, section 175A for maintenance proposes to determine that the area has plans . . . provides specific requirements for that, ‘‘In light of our disposition, we attained the 1997 PM2.5 standard. Under need not address the petitioners’ contingency measures that effectively its longstanding interpretation, EPA is supersede the requirements of section challenge to the presumptions in [40 172(c)(9) for these areas. proposing to determine here that the CFR 51.1002] that volatile organic area meets the attainment-related plan Id. compounds and ammonia are not PM2.5 requirements of subparts 1 and 4. precursors, as subpart 4 expressly EPA similarly stated in its 1992 Thus, EPA is proposing to conclude Calcagni memorandum that, ‘‘The governs precursor presumptions.’’ that the requirements to submit an NRDC v. EPA, at 27, n.10. requirements for reasonable further attainment demonstration under progress and other measures needed for Elsewhere in the Court’s opinion, 189(a)(1)(B), a RACM determination however, the Court observed: attainment will not apply for under section 172(c)(1) and section redesignations because they only have 189(a)(1)(c), a RFP demonstration under Ammonia is a precursor to fine particulate meaning for areas not attaining the 189(c)(1), and contingency measure matter, making it a precursor to both PM2.5 standard.’’ requirements under section 172(c)(9) are and PM10. For a PM10 nonattainment area It is evident that, even if we were to governed by subpart 4, a precursor is satisfied for purposes of evaluating the presumptively regulated. See 42 U.S.C. consider the Court’s January 4, 2013, redesignation request. decision in NRDC v. EPA to mean that § 7513a(e) [section 189(e)]. attainment-related requirements specific iii. Subpart 4 and Control of PM2.5 Id. at 21, n.7. For a number of reasons, to subpart 4 should be imposed Precursors EPA believes that its proposed retroactively 11 and, thus, are now past The D.C. Circuit in NRDC v. EPA redesignation of the Chicago area is due, those requirements do not apply to remanded to EPA the two rules at issue consistent with the Court’s decision on an area that is attaining the 1997 PM2.5 in the case with instructions to EPA to this aspect of subpart 4. First, while the standard, for the purpose of evaluating re-promulgate them consistent with the Court, citing section 189(e), stated that a pending request to redesignate the requirements of subpart 4. EPA, in this ‘‘for a PM10 area governed by subpart 4, area to attainment. EPA has consistently section, addresses the Court’s opinion a precursor is ‘presumptively enunciated this interpretation of with respect to PM2.5 precursors. While regulated,’’’ the Court expressly applicable requirements under section past implementation of subpart 4 for declined to decide the specific 107(d)(3)(E) since the General Preamble PM10 has allowed for control of PM10 challenge to EPA’s 1997 PM2.5 was published more than twenty years precursors, such as NOX from major implementation rule provisions ago. Courts have recognized the scope of stationary, mobile, and area sources, in regarding ammonia and VOC as EPA’s authority to interpret ‘‘applicable order to attain the standard as precursors. The Court had no occasion requirements’’ in the redesignation expeditiously as practicable, CAA to reach whether and how it was context. See Sierra Club v. EPA, 375 section 189(e) specifically provides that substantively necessary to regulate any F.3d 537 (7th Cir. 2004). control requirements for major specific precursor in a particular PM2.5 Moreover, even outside the context of stationary sources of direct PM10 shall nonattainment area, and did not address redesignations, EPA has viewed the also apply to PM10 precursors from what might be necessary for purposes of obligations to submit attainment-related those sources, except where EPA acting upon a redesignation request. SIP planning requirements of subpart 4 determines that major stationary sources However, even if EPA takes the view as inapplicable for areas that EPA of such precursors ‘‘do not contribute that the requirements of subpart 4 were determines are attaining the standard. significantly to PM10 levels which deemed applicable at the time the state EPA’s prior ‘‘Clean Data Policy’’ exceed the standard in the area.’’ submitted the redesignation request, rulemakings for the PM10 NAAQS, also EPA’s 1997 PM2.5 implementation and disregards the implementation rule, remanded by the D.C. Circuit, rule’s rebuttable presumptions regarding 11 As EPA has explained above, we do not believe contained rebuttable presumptions ammonia and VOC as PM2.5 precursors, that the Court’s January 4, 2013, decision should be interpreted so as to impose these requirements on concerning certain PM2.5 precursors the regulatory consequence would be to the states retroactively. Sierra Club v. Whitman, applicable to attainment plans and consider the need for regulation of all supra. control measures related to those plans. precursors from any sources in the area

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to demonstrate attainment and to apply redesignation of the area, which is conclude, in the context of this the section 189(e) provisions to major attaining the 1997 annual PM2.5 redesignation, that there is no need to stationary sources of precursors. In the standard, at present ammonia and VOC revisit the attainment control strategy case of the Chicago area, EPA believes precursors from major stationary with respect to the treatment of that doing so is consistent with sources do not contribute significantly precursors. Even if the Court’s decision proposing redesignation of the area for to levels exceeding the 1997 PM2.5 is construed to impose an obligation, in the 1997 PM2.5 standard. The Chicago standard in this area. See 57 FR 13539– evaluating this redesignation request, to area has attained the 1997 PM2.5 13542. consider additional precursors under standard without any specific additional EPA notes that its 1997 PM2.5 subpart 4, it would not affect EPA’s controls of VOC and ammonia Implementation Rule provisions in 40 approval here of Illinois’ request for CFR 51.1002 were not directed at emissions from any sources in the area. redesignation of the Chicago area. In the Precursors in subpart 4 are evaluation of PM precursors in the 2.5 context of a redesignation, the area has specifically regulated under the context of redesignation, but at SIP provisions of section 189(e), which plans and control measures required to shown that it has attained the standard. requires, with important exceptions, bring a nonattainment area into Moreover, the state has shown and EPA has proposed to determine that control requirements for major attainment of the 1997 PM2.5 NAAQS. 12 attainment in this area is due to stationary sources of PM10 precursors. By contrast, redesignation to attainment Under subpart 1 and EPA’s prior primarily requires the area to have permanent and enforceable emissions implementation rule, all major already attained due to permanent and reductions on all precursors necessary stationary sources of PM2.5 precursors enforceable emission reductions, and to to provide for continued attainment. It were subject to regulation, with the demonstrate that controls in place can follows logically that no further control exception of major stationary sources of continue to maintain the standard. of additional precursors is necessary. ammonia and VOC. Thus, we must Thus, even if we regard the Court’s Accordingly, EPA does not view the address here whether additional January 4, 2013, decision as calling for January 4, 2013, decision of the Court as controls of ammonia and VOC from ‘‘presumptive regulation’’ of ammonia precluding redesignation of the Chicago major stationary sources are required and VOC for the control of PM2.5 under area to attainment for the 1997 PM2.5 under section 189(e) of subpart 4 in the attainment planning provisions of NAAQS at this time. order to redesignate the area for the subpart 4, those provisions in and of In sum, even if Illinois were required 1997 PM2.5 standard. As explained themselves do not require additional to address precursors for the Chicago below, we do not believe that any controls of these precursors for an area area under subpart 4 rather than under additional controls of ammonia and that already qualifies for redesignation. subpart 1, as interpreted in EPA’s VOC are required in the context of this Nor does EPA believe that requiring redesignation. Illinois to address precursors differently remanded 1997 PM2.5 Implementation In the General Preamble, EPA than they have already would result in Rule, EPA would still conclude that the discusses its approach to implementing a substantively different outcome. area had met all applicable section 189(e). See 57 FR 13538–13542. Although, as EPA has emphasized, its requirements for purposes of With regard to precursor regulation consideration here of precursor redesignation in accordance with under section 189(e), the General requirements under subpart 4 is in the section 107(d)(3(E)(ii) and (v). Preamble explicitly stated that control context of a redesignation to attainment, C. Are the air quality improvements in of VOC under other CAA requirements EPA’s existing interpretation of subpart the Chicago-Gary-Lake County, IL–IN may suffice to relieve a state from the 4 requirements with respect to Area due to permanent and enforceable need to adopt precursor controls under precursors in attainment plans for PM10 section 189(e). 57 FR 13542. EPA, in contemplates that states may develop emission reductions? this proposal, proposes to determine attainment plans that regulate only Section 107(d)(3)(E)(iii) of the CAA that the SIP has met the provisions of those precursors that are necessary for requires the state to demonstrate that section 189(e) with respect to ammonia purposes of attainment in the area in the improvement in air quality is due to and VOC as precursors. This proposed question, i.e., states may determine that permanent and enforceable emission supplemental determination is based on only certain precursors need be reductions. EPA finds that Illinois has our findings that: (1) The Chicago area regulated for attainment and control demonstrated that the observed PM contains no major stationary sources of purposes.14 Courts have upheld this 2.5 air quality improvement in the Chicago- ammonia; and (2) existing major approach to the requirements of subpart Gary-Lake County, IL–IN area is due to stationary sources of VOC are 4 for PM .15 EPA believes that 10 permanent and enforceable emission adequately controlled under other application of this approach to PM2.5 reductions. In making this provisions of the CAA regulating the precursors under subpart 4 is ozone NAAQS.13 In the alternative, EPA reasonable. Because the Chicago area demonstration, Illinois first determined and documented the change in primary proposes to determine that, under the has already attained the 1997 PM2.5 express exception provisions of section NAAQS with its current approach to PM2.5, NOX, and SO2 emissions in the Chicago-Gary-Lake County, IL–IN area 189(e), and in the context of the regulation of PM2.5 precursors, EPA believes that it is reasonable to between 2002 (a standard-violation 12 Under either subpart 1 or subpart 4, for year) and 2008 (an attainment year). purposes of demonstrating attainment as 14 See, e.g., ‘‘Approval and Promulgation of Illinois demonstrated that the reduction expeditiously as practicable, a state is required to Implementation Plans for California-San Joaquin in emissions and the corresponding evaluate all economically and technologically Valley PM–10 Nonattainment Area; Serious Area improvement in air quality over the feasible control measures for direct PM emissions Plan for Nonattainment of the 24-Hour and Annual and precursor emissions, and adopt those measures PM–10 Standards,’’ 69 FR 30006 (May 26, 2004) intervening period (2002–2008) can be that are deemed reasonably available. (approving a PM10 attainment plan that imposed attributed to a number of regulatory 13 The Chicago area has reduced VOC emissions controls on direct PM10 and NOX emissions and did control measures that have been through the implementation of various control not impose controls on SO2, VOC, or ammonia implemented in the Chicago-Gary-Lake programs including VOC RACT regulations and emissions). various on-road and non-road motor vehicle control 15 See, e.g., Assoc. of Irritated Residents v. EPA County, IL–IN area and in surrounding programs. et al., 423 F.3d 989 (9th Cir. 2005). contributing areas in the recent years.

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1. Permanent and Enforceable Controls reductions in fuel sulfur content starting in 2004 and Tier 2 starting in The following is a discussion of the occurred by the 2008–2010 attainment 2007. Recreational vehicle emission permanent and enforceable measures period. Some of the emissions standards were phased in from 2004 that have been implemented in the reductions resulting from new vehicle through 2012. Marine diesel engine Chicago area and in upwind areas. standards also occurred during the standards were phased in from 2006 2008–2010 attainment period; however, through 2009. a. Federal Emission Control Measures additional emission reductions will With full implementation of all of the Reductions in PM2.5 precursor continue to occur throughout the non-road spark-ignition engine and emissions have occurred statewide in maintenance period as the fleet of older recreational engine standards, an overall Illinois and in upwind areas as a result heavy-duty diesel engines turns over. 72 percent reduction in VOC, 80 percent of the following Federal emission This rule will also lower SO2 emissions reduction in NOX, and 56 percent control measures, with additional from engines using the low sulfur diesel reduction in carbon monoxide (CO) emission reductions expected in the fuel, resulting in lower PM2.5 emissions are expected by 2020. Some future. Federal emission control concentrations; however, EPA has not of these emission reductions occurred measures include the following. estimated the level of this emission by the 2008–2010 attainment period, reduction and the level of its impact on and additional emission reductions will i. Tier 2 Emission Standards for PM2.5 concentrations. occur during the maintenance period as Vehicles and Gasoline Sulfur Standards the fleets turn over. iii. Non-Road Diesel Engine Standards 40 CFR part 86, subpart S. These b. Control Measures Statewide in emission control requirements result in On June 29, 2004 (69 FR 38958), EPA Illinois and in Upwind Areas lower VOC, NOX, and SO2 emissions promulgated a rule to establish emission from new cars and light duty trucks, standards for large non-road diesel Due to the significance of sulfates and including sport utility vehicles. The engines, such as those used in nitrates as components of PM2.5 in the Federal rules were phased in between construction, agriculture, or mining Chicago-Gary-Lake County, IL–IN area, 2004 and 2009. The EPA has estimated operations, and to regulate the sulfur the PM2.5 air quality in this area is that, by the end of the phase-in period, content in non-road diesel fuel. The strongly affected by regulation of SO2 the following vehicle NOX emission engine emission standards in this rule and NOX emissions from power plants reductions will occur nationwide: are to be phased in between 2008 and in areas upwind of the Chicago-Gary- passenger cars (light duty vehicles), 77 2014. This rule reduced the allowable Lake County, IL–IN area. The emission percent; light duty trucks, minivans, sulfur content in non-road diesel fuel by control regulations impacting the and sports utility vehicles, 86 percent; over 99 percent. Prior to 2006, non-road upwind area include the following. diesel fuel averaged approximately and, larger sports utility vehicles, vans, i. NO SIP Call and heavier trucks, 69 to 95 percent. 3,400 ppm in sulfur content. This rule X VOC emission reductions will be limited non-road diesel fuel content to On October 27, 1998 (63 FR 57356), approximately 12 percent for passenger 500 ppm starting in 2007, with a further EPA issued a NOX SIP call requiring the cars, 18 percent for smaller sports utility reduction to 15 ppm starting in 2010. District of Columbia and 22 states to vehicles, light trucks, and minivans, and The combined engine standards and reduce emissions of NOX from Electric 15 percent for larger sports utility vans, fuel sulfur content limits reduce NOX Generating Units (EGUs), large and heavier trucks. Some of the and PM2.5 emissions (including direct industrial boilers, and cement kilns. emission reductions resulting from new emissions of sulfates) from large non- Affected states were required to comply vehicle standards occurred during the road diesel engines by over 90 percent with Phase I of the SIP call beginning in 2008–2010 attainment period; however, compared to pre-control non-road 2004, and with Phase II beginning in additional emission reductions will engines using the higher sulfur content 2007. NOX emission reductions continue to occur throughout the fuel. This rule achieved all of the resulting from regulations developed in maintenance period as new vehicles reductions in fuel sulfur content by response to the NOX SIP call are replace older vehicles. The Tier 2 2010. Some emission reductions from permanent and enforceable. The state of standards also reduced the sulfur the new engine emission standards were Illinois and other nearby upwind states, content of gasoline to 30 parts per realized over the 2008–2010 period; including Michigan, Indiana, and million (ppm) beginning in January although most of the engine emission Kentucky were subject to the NOX SIP 2006. reductions will occur during the call. maintenance period as the fleet of non- ii. Clean Air Interstate Rule (CAIR) and ii. Heavy-Duty Diesel Engine Rule road diesel engines turns over. EPA issued this rule on January 18, Cross-State Air Pollution Rule (CSAPR) 2001 (66 FR 5002). This rule went into iv. Non-Road Spark-Ignition Engines EPA proposed CAIR on January 30, effect in 2004 and includes standards and Recreational Engine Standards 2004, at 69 FR 4566, promulgated CAIR limiting the sulfur content of diesel fuel. On November 8, 2002 67 FR 68243), on May 12, 2005, at 70 FR 25162, and A second phase took effect in 2007 and EPA promulgated emission standards promulgated associated Federal resulted in reduced PM2.5 emissions for groups of previously unregulated Implementation Plans (FIPs) on April from heavy-duty highway diesel engines non-road engines. These engines 28, 2006, at 71 FR 25328, in order to and further reduced the highway diesel include large spark-ignition engines, reduce SO2 and NOX emissions and fuel sulfur content to 15 ppm. The full such as those used in forklifts and improve air quality in areas across implementation of this rule is estimated airport ground-service equipment; Eastern United States. However, on July to achieve a 90 percent reduction in recreational vehicles using spark- 11, 2008, the D.C. Circuit vacated and direct PM2.5 emissions (including direct ignition engines, such as off-highway remanded both CAIR and the associated emissions of sulfates) and a 95 percent motorcycles, all-terrain vehicles, and CAIR FIPs in their entirety. See North reduction of NOX emissions for new snowmobiles; and, recreational marine Carolina v. EPA, 531 F.3d 836 (D.C. Cir. engines using low sulfur diesel fuel, diesel engines. Emission standards for 2008). EPA petitioned for a rehearing, compared to existing engines using large spark-ignition engines were and the D.C. Circuit issued an order higher sulfur content fuel. The implemented in two tiers, with Tier I remanding CAIR and the CAIR FIPs to

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EPA without vacatur. See North Exxon Mobil refineries (and other 2. Emission Reductions Carolina v. EPA, 550 F.3d 1176 (D.C. refineries in Illinois) to operate controls a. Illinois’ Demonstration That Cir. 2008). The D.C. Circuit, thereby, left at the Best Available Control Significant Emission Reductions Have CAIR in place in order to ‘‘temporarily Technology (BACT) level. Illinois Occurred in the Chicago-Gary-Lake preserve the environmental values evaluated the subject-to-BART units at County, IL–IN Area and In Upwind covered by CAIR’’ until EPA replaced it the CITGO and Exxon Mobil refineries Areas with a rule consistent with the Court’s in the consent decree. It found that the opinion. Id. at 1178. The Court directed NOX and SO2 emission limits for these To demonstrate that significant EPA to ‘‘remedy CAIR’s flaws’’ units satisfy BART. emission reductions have resulted in consistent with the July 11, 2008 A consent decree between the United attainment, Illinois compared the opinion, but declined to impose a States and CITGO Petroleum Chicago area NOX, SO2, and primary schedule on EPA for completing this Corporation was entered in the U.S. PM2.5 emissions for 2002 with those of action. Id. District Court for the Southern District 2008. As noted above, the 2008 EPA promulgated CSAPR (76 FR of Texas on October 6, 2004 (No. H–04– emissions represent those for a year in 48208, August 8, 2011) to replace CAIR. 3883). The consent decree requires the which the Chicago-Gary-Lake County, See 76 FR 59517. As noted above, CAIR company to operate Selective Catalytic IL–IN area was attaining the 1997 requires significant reductions in Reduction (SCR) and a wet scrubbing annual PM2.5 standard (2008 is the emissions of SO2 and NOX from electric system at its Fluid Catalytic Cracking middle year of the 2007–2009 period in generating units to limit the interstate Unit (FCCU) that will reduce NOX which the Chicago-Gary-Lake County, transport of these pollutants and the emissions by more than 90 percent and IL–IN area initially attained the 1997 ozone and fine particulate matter they SO2 emissions by 85 percent. The annual PM2.5 standard), and 2002 form in the atmosphere. See 76 FR controls on the FCCU are expected to represents a year in which the Chicago- 70093. result in a reduction of NOX emissions Gary-Lake County, IL–IN area was On August 21, 2012, the D.C. Circuit from 1,065.7 to 106.6 TPY and SO2 violating this standard. issued a decision to vacate CSAPR. In emissions from 10,982.5 to 107.9 TPY The derivation of the 2002 (base year) that decision, it also ordered EPA to by 2013. CITGO has also added a tail gas emissions is discussed in more detail continue administering CAIR ‘‘pending recovery unit that reduces SO2 below in section V.F. The derivation of the promulgation of a valid emissions from its sulfur train units the 2008 (attainment year) emissions is replacement.’’ EME Homer City, 696 from 4340.0 to 91.2 TPY, a 98 percent discussed in more detail here. F.3d at 38. The D.C. Circuit denied all reduction. The emission controls on all The 2008 emissions were based on petitions for rehearing on January 24, units at CITGO’s Lemont refinery will actual source activity levels. The point source emissions were compiled from 2013. EPA and other parties have filed reduce NOX emissions by 1,268 TPY Illinois’ 2008 Annual Emissions Reports petitions for certiorari to the U.S. and SO2 emissions by 15,123 TPY. Supreme Court. On June 24, 2013, the A consent decree between the United (AERs) submitted to the IEPA by U.S. Supreme Court granted the States and Exxon Mobil Corporation individual source facilities. Area source petitions for certiorari. Nonetheless, was entered in the U.S. District Court emissions were calculated using the EPA intends to continue to act in for the Northern District of Illinois on most recently available emission accordance with the EME Homer City October 11, 2005 (No. O5–C–5809). The calculation methodologies, emission opinion until the U.S. Supreme Court consent decree for Exxon Mobil requires factors developed by EPA, and activity issues its decision. SCR operation on its FCCU in addition data (population, employment, fuel use, In light of these unique circumstances to maintenance of the existing wet etc.) specific to 2008. On-road mobile and for the reasons explained below, to scrubbing system. The controls on the source emissions were calculated using the extent that attainment is due to FCCU result in a 1,636.2 TPY decrease EPA’s MOVES emissions model with emission reductions associated with in NOX emissions from 1,818.0 to 181.8 2008 Vehicle Miles Traveled (VMT) data CAIR, EPA is here proposing to TPY and a 9,667.7 TPY decrease in SO2 provided by the Illinois Department of determine that these emission emissions from 9,865.0 to 197.3 TPY. Transportation (IDOT). Off-road mobile reductions are sufficiently permanent Exxon Mobil has also added a tail gas source emissions were calculated using and enforceable for purposes of CAA recovery unit on its south sulfur either EPA’s NONROAD emission section 107(d)(3)(E)(iii) (and for recovery unit. That unit reduces SO2 model (for all non-road sources except purposes of assessing maintenance of emissions by 9,153.8 TPY to 186.8 TPY. commercial marine vessels, the 1997 annual PM2.5 standard in the The emission controls at Exxon Mobil’s locomotives, and aircraft) or information Chicago-Gary-Lake County, IL–IN area, Joliet refinery will reduce NOX supplied by contractors (for marine as discussed below, for CAA section emissions by 1,695 TPY and SO2 vessels, locomotives, and aircraft). 175A). emissions by 18,821 TPY. Biogenic emissions were not included These two consent decrees are in the emission inventories since these c. Consent Decrees Federally enforceable and also require emissions are assumed to remain Two petroleum refineries, the CITGO that the refineries submit permit constant over time (biogenic emissions and Exxon Mobil refineries, have units applications to Illinois to incorporate are not included in the 2002, 2008, subject to Best Available Retrofit the required emission limits into 2015, and 2025 emissions summarized Technology (BART) requirements for Federally enforceable air permits (other in this proposed rule). purposes of achieving reduced haze than Title V). Therefore, emission limits The 2002 and 2008 Chicago area levels: The CITGO refinery in Lemont, established by the consent decrees may emissions (covering only the Illinois Illinois and the Exxon Mobil refinery be relied upon by Illinois for addressing portion of the Chicago-Gary-Lake south of Joliet, Illinois. Both refineries the BART requirement for these County, IL–IN area) are summarized in will be required to reduce emissions by facilities and for crediting toward the tables 3 through 5 below. All emissions a Federal consent decree resolving an reduction of PM2.5 levels in the Chicago are in units of TPY. All summarized enforcement action brought by EPA area and maintenance of the 1997 emissions are documented in Illinois’ against a number of refineries. The annual PM2.5 standard in the Chicago- August 17, 2011 ‘‘Maintenance Plan for consent decrees require the CITGO and Gary-Lake County, IL–IN area. the Chicago Nonattainment Area for the

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1997 PM2.5 National Ambient Air Quality Standards (Revised).’’

TABLE 3—COMPARISON OF 2002 AND 2008 NOX EMISSION TOTALS FOR THE CHICAGO AREA BY SOURCE SECTOR (TPY)

Net change Source sector 2002 2008 2002–2008

Point Sources ...... 54,050 35,939 ¥18,111 Area Sources ...... 32,325 32,318 ¥7 On-Road Mobile Sources ...... 187,632 127,951 ¥59,681 Off-Road Mobile Sources ...... 87,426 51,184 ¥36,242

Total ...... 361,433 247,391 ¥114,042

TABLE 4—COMPARISON OF 2002 AND 2008 PRIMARY PM2.5 EMISSION TOTALS FOR THE CHICAGO AREA BY SOURCE SECTOR (TPY)

Net change Source sector 2002 2008 2002–2008

Point Sources ...... 2,757 3,859 1,102 Area Sources ...... 22,356 9,189 ¥13,167 On-Road Mobile Sources ...... 6,573 5,100 ¥1,473 Off-Road Mobile Sources ...... 4,834 3,653 ¥1,181

Total ...... 36,520 21,800 ¥14,720

TABLE 5—COMPARISON OF 2002 AND 2008 SO2 EMISSION TOTALS FOR THE CHICAGO AREA BY SOURCE SECTOR (TPY)

Net change Source sector 2002 2008 2002–2008

Point Sources ...... 121,598 90,706 ¥30,892 Area Sources ...... 3,290 4,109 819 On-Road Mobile Sources ...... 4,472 537 ¥3,935 Off-Road Mobile Sources ...... 3,743 779 ¥2964

Total ...... 133,103 96,130 ¥36,973

Tables 3 through 5 show that NOX, Chicago-Gary-Lake County, IL–IN area. concentrations in Cook County, Illinois SO2, and primary PM2.5 emissions in the To assess the change in regional (a modeling receptor site considered to Chicago area have decreased emissions from states believed to be representative of the regional significantly between 2002 and 2008. significantly contribute to annual PM2.5 transport into the Chicago-Gary-Lake In addition to the local PM2.5 concentrations in the Chicago-Gary-Lake County, IL–IN area. Table 6 summarizes precursor emission reductions, we County, IL–IN area, we have considered statewide NOX and SO2 emissions for believe that regional NOX and SO2 statewide NOX and SO2 emissions from EGUs previously summarized in the emission reductions resulting from the EGUs reported for 2002 and 2008 in proposed rule for the redesignation of implementation of EPA’s Acid Rain EPA’s ARP/CAIR database. To limit the Lake and Porter Counties, Indiana to Program (ARP) (see 40 CFR parts 72 number of states considered, we have attainment of the 1997 annual PM through 78), NO SIP call, and CAIR selected those states with emissions that 2.5 X standard. See 76 FR 59600, 59608– have significantly contributed to the have been modeled to have significantly 59609, September 27, 2011. PM2.5 air quality improvement in the contributed to elevated PM2.5

TABLE 6—STATEWIDE EGU EMISSIONS FOR 2002 AND 2008 (TPY)

NOX SO2 State Percent Percent 2002 2008 reduction 2002 2008 reduction

Illinois ...... 174,246 119,930 31.2 353,699 257,357 27.2 Indiana ...... 281,146 190,092 32.4 778,868 565,459 27.4 Iowa ...... 78,956 49,023 37.9 127,847 109,293 14.5 Kentucky ...... 198,598 157,903 21.4 482,653 344,356 28.7 Michigan ...... 132,623 107,623 18.9 342,998 326,500 4.8

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TABLE 6—STATEWIDE EGU EMISSIONS FOR 2002 AND 2008—Continued (TPY)

NOX SO2 State Percent Percent 2002 2008 reduction 2002 2008 reduction

Minnesota ...... 86,663 60,230 30.5 101,285 71,926 29.0 Ohio ...... 370,497 235,049 36.6 1,132,069 709,914 37.3 Pennsylvania ...... 200,909 183,658 8.6 889,765 831,914 6.5 Wisconsin ...... 88,970 47,794 46.3 181,256 129,693 32.1

Total ...... 1,612,708 1,151,302 28.6 4,400,440 3,346,412 24.0

As can be seen in table 6, the ammonia emissions throughout the demonstrates that emissions in the implementation of CAIR resulted in Chicago area are very low, estimated to Chicago area will remain at or below the significant reductions in regional, be 9,885.71 TPY in 2002. See table 12 attainment levels throughout the statewide NOX and SO2 emissions from below. This amount of ammonia maintenance period and provides for EGUs in the states EPA finds are emissions appears especially small in corrective action should the 1997 contributing significantly to the annual comparison to the total amounts of SO2, annual standard be violated or PM2.5 concentrations in the Chicago- NOX, and even direct PM2.5 emissions in threatened in the Chicago-Gary-Lake Gary-Lake County, IL–IN area. Since the area in 2002. Third, as described County, IL–IN area during the CAIR remains in place until EPA can below, available information shows that maintenance period. The following replace it with an acceptable new no PM2.5 precursor, including VOC and summarizes the details of the region-wide emissions control rule, we ammonia, is expected to increase over maintenance plan and maintenance believe these emission reductions to be the maintenance period so as to demonstration. permanent and enforceable. interfere with or undermine the state’s Based on the information summarized maintenance demonstration. 1. What is required in a maintenance above, primary PM and precursor plan? 2.5 c. Conclusions Regarding Emission PM2.5 emissions (SO2 and NOX) have Sections 107(d)(3)(E)(iv) and 175A of significantly decreased between 2002 Reductions Between 2002 and 2005 in the Chicago Area the CAA require that states demonstrate and 2008 in the Chicago area and in that the areas to be redesignated will In summary, emissions data provided states with EGU emissions significantly continue to meet the PM2.5 NAAQS for impacting the annual PM2.5 by the state support the conclusion that at least 10 years after EPA approves the concentrations in the Chicago area. significant reductions in the emissions redesignations of the areas to attainment of SO2, NOX, primary PM2.5, and VOC of the NAAQS. Section 175A of the b. VOC and Ammonia Emission occurred in the Chicago area between Reductions CAA sets forth the required elements of 2002 and 2008. During the same period, a maintenance plan. Under section For several reasons, we believe that emissions of ammonia are believed to 175A, a state must also commit to VOC emission reductions in the Chicago have had minimal impact on PM2.5 submit a revised maintenance plan area and in upwind states have also concentrations in the Chicago area. We within eight years of redesignation to contributed to the observed believe that the emission reductions of provide for maintenance of the standard improvement in annual PM2.5 the significant PM precursors and 2.5 for an additional 10 years after the concentrations in the Chicago area and primary PM in the Chicago area and 2.5 initial 10-year maintenance period. To in the Chicago-Gary-Lake County, IL–IN in upwind states are responsible for the address the possibility of future NAAQS area as a whole. In addition, for several observed improvement in annual PM 2.5 violations, the maintenance plan must reasons, we also believe that changes in concentrations in the Chicago-Gary-Lake contain contingency measures with a ammonia emissions have not County, IL–IN area. For the reasons set schedule for implementation, as EPA significantly impacted the observed forth above, we conclude that the deems necessary, to assure prompt annual PM2.5 concentrations in these attainment of the 1997 annual PM 2.5 correction of any future violations of the areas. standard in the Chicago area can be First, as noted elsewhere in this explained on the basis of permanent and standard. proposed rule in EPA’s discussion of enforceable emission reductions within The September 4, 1992, Calcagni section 189(e) of the CAA, VOC the Chicago area and in the states memorandum provides additional emissions in the Chicago area have regulated by CAIR. guidance on the content of a historically been well-controlled under maintenance plan. The memorandum SIP requirements related to ozone and D. Does Illinois have a fully approvable states that a maintenance plan should other pollutants.16 Second, total PM2.5 maintenance plan pursuant to address the following items: (1) The section 175A of the CAA for the Chicago attainment emission inventories; (2) a 16 For a thorough discussion of VOC emission area? maintenance demonstration showing controls and estimates (2002 and 2008) and In conjunction with Illinois’ request maintenance of the standard for the 10 projected (2015, 2020, and 2025) VOC emission years of the maintenance period; (3) a levels (summertime emissions) in the Chicago area, to redesignate the Chicago area to see EPA’s proposed rule for the redesignation of the attainment of the 1997 annual PM2.5 commitment to maintain the existing Chicago area to attainment of the 1997 8-hour ozone standard, IEPA submitted a SIP revision monitoring network; (4) the factors and standard (77 FR 6743, February 9, 2012). We to provide for maintenance of the 1997 procedures to be used for verification of observe here that the estimated/projected summertime VOC emission reductions in the annual PM2.5 standard in the Chicago- continued attainment of the standard; Chicago area also generally reflect reductions in Gary-Lake County, IL–IN area through and (5) a contingency plan to prevent or annual emissions of VOC in this area. 2025. This maintenance plan correct future violations of the standard.

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2. Attainment Inventory v. EPA, 265 F.3d 426 (6th Cir. 2001), standards, and the operation of an Sierra Club v. EPA, 375 F.3d 537 (7th enhanced vehicle inspection and As noted above, IEPA developed NOX, Cir. 2004). See also 66 FR 53094, 53099– SO2, and primary PM2.5 emission maintenance program in the Chicago inventories for 2008, one of the years 53100 (October 19, 2001), 68 FR 25413, area. Total VMT for 2015, 2020, and used to demonstrate monitored 25430–25432 (May 12, 2003). 2025 were derived by assuming that the attainment of the 1997 annual PM2.5 Illinois used emission projections for VMT will increase at a rate of 1.5 standard. The 2008 emissions are 2015, 2020, and 2025 to demonstrate percent per year after 2008. The 2008 summarized in tables 3 through 5 above. maintenance. For each of the applicable and 2025 on-road mobile source PM2.5 precursors (pollutants), IEPA emissions were used to establish MVEBs 3. Demonstration of Maintenance prepared emission estimates for the for the Chicago area. See the additional Along with the redesignation request, same source sectors used by IEPA for discussion of the MVEBs in section V.E IEPA submitted a maintenance plan the 2008 attainment year. IEPA assumed of this proposed rule. dated August 17, 2011, which includes biogenic emissions to remain constant, Chicago area point and area source a demonstration of maintenance for the and did not consider them in the emissions for 2015, 2020, and 2025 were Chicago area, as required by section maintenance demonstration analysis. 175A of the CAA. This demonstration IEPA used EPA’s MOVES mobile estimated using the 2008 attainment shows maintenance of the 1997 annual source model and projected traffic levels year emissions and growth factors appropriate for each source category. PM2.5 standard through 2025 by and other related mobile source factors showing that current and future to estimate on-road mobile source Off-road emission projections were developed using the growth factors emissions of NOX, SO2, and primary emissions for the maintenance contained in EPA’s NONROAD model. PM2.5 emissions for the Chicago area demonstration years. The projected on- will remain at or below attainment year road mobile source emissions assume Tables 7 through 9 summarize the emission levels. A maintenance the continued use of reformulated projected NOX, SO2, and primary PM2.5 demonstration may be based on such an gasoline, the continued phase-in of the emissions for 2008, 2015, 2020, and emissions inventory approach. See Wall Tier 2 motor vehicle emission 2025 by source sector.

TABLE 7—COMPARISON OF 2008, 2015, 2020, AND 2025 NOX EMISSIONS BY SOURCE SECTOR (TPY) FOR THE CHICAGO AREA

Net change Source sector 2008 2015 2020 2025 2008–2025

Point Sources...... 35,939 27,082 28,500 29,638 ¥6,301 Area Sources...... 32,318 32,997 33,277 33,687 1,369 On-Road Mobile ...... 127,951 68,491 40,599 38,456 ¥89,495 Off-Road Mobile...... 51,184 35,927 28,271 27,173 ¥24,011

Totals ...... 247,391 164,497 130,648 128,954 ¥118,437

TABLE 8—COMPARISON OF 2008, 2015, 2020, AND 2025 SO2 EMISSIONS BY SOURCE SECTOR (TPY) FOR THE CHICAGO AREA

Net change Source sector 2008 2015 2020 2025 2008–2025

Point Sources...... 90,706 58,092 53,452 56,310 ¥34,396 Area Sources ...... 4,109 4,266 4,332 4,407 298 On-Road Mobile ...... 537 504 477 488 ¥49 Off-Road Mobile ...... 779 866 919 1,215 436

Totals ...... 96,130 63,727 59,180 62,420 ¥33,710

TABLE 9—COMPARISON OF 2008, 2015, 2020, AND 2025 PRIMARY PM2.5 EMISSIONS BY SOURCE SECTOR (TPY) FOR THE CHICAGO AREA

Net change Source sector 2008 2015 2020 2025 2008–2025

Point Sources...... 3,859 4,169 4,391 4,604 745 Area Sources ...... 9,189 9,676 10,009 10,377 1,188 On-Road Mobile...... 5,100 3,071 2,119 2,067 ¥3,033 Off-Road Mobile...... 3,653 2,995 2,398 2,267 ¥1,386

Totals ...... 21,800 19,911 18,918 19,316 ¥2,484

Comparison of the 2008 and projected will remain below the 2008 levels in the redesignation of Lake and Porter 2015, 2020, and 2025 emissions Chicago area. Counties, Indiana (the Indiana portion demonstrates that future NOX, SO2, and In a September 27, 2011 proposed of the Chicago-Gary-Lake County, IL–IN primary PM2.5 emissions through 2025 rulemaking (76 FR 59600, 59610) for the area) to attainment of the 1997 annual

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PM2.5 standard, we also evaluated the County, IL–IN area. Table 10 repeats the documented in the September 27, 2011 2008, 2015, 2020, and 2025 emissions summary of the area’s emission totals as proposed rule. for the entire Chicago-Gary-Lake

TABLE 10—CHICAGO-GARY-LAKE COUNTY, IL–IN AREA 2008 AND PROJECTED EMISSION TOTALS [TPY]

Year NOX SO2 Primary PM2.5

2008 ...... 278,649.74 152,367.68 32,069.68 2015 ...... 187,557.31 107,285.55 25,128.65 2020 ...... 156,231.26 98,829.89 24,729.26 2025 ...... 149,198.79 99,453.24 25,074.10

Tables 7 through 10 show that implementation of the contingency measures will be implemented within emissions will remain at or below 2008 measures, and a time limit for action by 18 months of the violation. Potential emission levels in the Chicago area and the state. The state should also identify control measures contained in Illinois’ in the Chicago-Gary-Lake County, IL–IN specific indicators to be used to contingency plan include the following: area through 2025. Therefore, the state determine when the contingency • Illinois’ Multi-Pollutant Program for has demonstrated maintenance of the measures need to be adopted and EGUs 1997 annual PM2.5 standard for a period implemented. The maintenance plan • NOX RACT extending ten years and beyond from must include a requirement that the • Best Available Retrofit Technology the time EPA may be expected to state will implement all measures with (BART) complete rulemaking on the state’s respect to control of the pollutant(s) that • Broader geographic applicability of PM2.5 redesignation request. were controlled through the SIP before existing control measures redesignation of the area to attainment. • Tier 2 vehicle standards and low 4. Monitoring Network See section 175A(d) of the CAA. sulfur fuel standard Illinois commits to continue As required by section 175A of the • Heavy duty diesel standards and low monitoring PM2.5 levels according to the CAA, Illinois has adopted a contingency sulfur diesel fuel standard EPA-approved monitoring plan, as plan for the Chicago area to address • High-enhanced vehicle inspection/ required to ensure maintenance of the possible future violations of the 1997 maintenance (On-board Diagnostics II 1997 annual PM2.5 standard. If changes annual PM2.5 standard. The contingency (OBDII)) are needed in the PM2.5 monitoring plan provides for two levels of action. • Federal railroad/locomotive standards network, the IEPA will work with the A Level I response would be triggered • Federal commercial marine vessel EPA to ensure the adequacy of the whenever: (1) The highest monitored engine standards • monitoring network. PM2.5 concentration in any year at any Architectural/Industrial Maintenance monitoring station in the Chicago (AIM) coatings 5. Verification of Continued Attainment maintenance area exceeds 15 mg/m3; or • Commercial and consumer products Continued attainment of the 1997 (2) the Chicago maintenance area’s total rules • annual PM2.5 standard in the Chicago PM2.5, SO2 or NOX emissions increase Aerosol coating rules, and area and in the Chicago-Gary-Lake more than 5 percent above the 2008 • Portable fuel container rules. County, IL–IN area depends, in part, on emissions. A Level I trigger will result Note that some of these rules are Federal the state’s efforts toward tracking in an evaluation of current PM2.5 air rules and are already being indicators of continued attainment quality and/or emission trends to implemented. If a future violation of the during the maintenance period. Illinois’ determine if adverse emission trends are 1997 annual PM2.5 occurs, IEPA will plan for verifying continued attainment likely to continue. If so, Illinois will analyze the future emission reduction of the standard in these areas consists of determine what and where controls may potential from these rules to determine continued ambient PM2.5 monitoring in be required, as well as level of if these future emission reductions will accordance with the requirements of 40 emissions reductions needed, to avoid a be sufficient to mitigate the PM2.5 air CFR part 58 and continued tracking of violation of the NAAQS. The study will quality problem. emissions through periodic updates of be completed within 9 months. If EPA believes that Illinois’ PM2.5, SO2 and NOX emissions necessary, control measures will be contingency plan satisfies the pertinent inventories for the Chicago area, as adopted within 18 months of requirements of section 175A of the required by the Federal Consolidated determination of the Level I triggering CAA. Emission Reporting Rule (codified at 40 and implemented as expeditiously as 7. Provision for Future Update of the CFR 51 subpart A). practicable, taking into consideration the ease of implementation and the Annual PM2.5 Maintenance Plan 6. Contingency Plan technical and economic feasibility of the As required by section 175A(b) of the Section 175A of the CAA requires that selected measures. CAA, Illinois commits to submit to EPA a maintenance plan include such A Level II response will be triggered an updated maintenance plan eight contingency measures as EPA deems if a violation of the 1997 annual PM2.5 years after EPA redesignates the Chicago necessary to ensure that the state will standard occurs at any monitoring area to attainment of the 1997 annual promptly correct a violation of the station in the Chicago maintenance area. standard. The revised maintenance plan NAAQS that might occur after If triggered, Illinois will conduct an is intended to cover an additional 10- redesignation. The maintenance plan analysis to determine appropriate year period beyond the initial 10-year should identify the contingency measures to address the cause of the maintenance period. As required by measures to be adopted, a schedule and violation. Analysis will be completed section 175A of the CAA, Illinois has procedure for adoption and within six months. Selected control also committed to retain and implement

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the emission control measures continue administrating CAIR ‘‘pending believes that CAIR emission reductions contained in the maintenance plan. If . . . development of a valid many be relied upon until the necessary changes are needed in the control replacement.’’ EME Homer City at 38. actions are taken by EPA and states to measures, Illinois commits to submit The D.C. Circuit denied all petitions for administer CAIR’s replacement. these changes to EPA as requested SIP rehearing on January 24, 2013. EPA and Furthermore, the Court’s instruction revisions and to demonstrate that these other parties have filed petitions for provides an additional backstop: by emission control measure revisions will certiorari to the U.S. Supreme Court. On definition, any rule that replaces CAIR not interfere with the maintenance of June 24, 2013, the U.S. Supreme Court and meets the Court’s direction would the 1997 annual PM2.5 standard in the granted the petitions for certiorari. require upwind states to have SIPs that Chicago-Gary-Lake County, IL–IN area. Nonetheless, EPA intends to continue to eliminate any significant contributions Finally, the state affirms that Illinois act in accordance with the EME Homer to downwind nonattainment and has the legal authority to implement and City opinion until the U.S Supreme prevent interference with maintenance enforce the requirements of the Court issues its decision. in downwind areas. maintenance plan pursuant to the In light of these unique circumstances Moreover, in vacating CSAPR and Illinois Environmental Protection Act. and for the reasons explained below, to requiring EPA to continue administering the extent that attainment and CAIR, the D.C. Circuit emphasized that 8. CAIR and CSAPR maintenance is due to emission the consequences of vacating CAIR a. Background—Effect of the August 21, reductions associated with CAIR, EPA is ‘‘might be more severe now in light of 2012, D.C. Circuit Decision Regarding here determining that those reductions the reliance interests accumulated over EPA’s CSAPR are sufficiently permanent and the intervening four years.’’ EME Homer enforceable for purposes of CAA City, 696 F.3d at 38. The accumulated EPA recently promulgated CSAPR (76 sections 107(d)(3)(E)(iii) and 175A. reliance interests include the interests of FR 48208, August 8, 2011) to replace As directed by the D.C. Circuit, CAIR states that reasonably assumed they CAIR, which has been in place since remains in place and enforceable until could rely on reductions associated with 2005. See 76 FR 59517. CAIR requires EPA promulgates a valid replacement CAIR which brought certain significant reductions in emissions of rule to substitute for CAIR. As noted nonattainment areas into attainment SO2 and NOX from EGUs to limit the above, the Chicago area PM2.5 with the NAAQS. If EPA were interstate transport of these pollutants redesignation request and maintenance prevented from relying on reductions and the ozone and PM2.5 they form in plan relies on the emission reductions associated with CAIR in redesignation the atmosphere. See 76 FR 70093. The from CAIR. Illinois adopted CAIR actions, states would be forced to D.C. Circuit initially vacated CAIR, emission control rules in 2007 and impose additional, redundant North Carolina v. EPA, 531 F.3d 896 required compliance with these rules in reductions on top of those achieved by (D.C. Cir. 2008), but ultimately two phases, one with compliance CAIR. EPA believes this is precisely the remanded that rule to EPA without required by 2009, and the final phase type of irrational result the Court sought vacatur to preserve the environmental with compliance required by 2015. to avoid by ordering EPA to continue benefits provided by CAIR, North CAIR was, thus, in place and getting administering CAIR. For these reasons Carolina v. EPA, 550 F.3d 1176, 1178 emission reductions when the Chicago- also, EPA believes it is appropriate to (D.C. Cir. 2008). Gary-Lake County, IL–IN area was allow states to rely on CAIR, and the CSAPR included regulatory changes monitoring attainment of the 1997 existing emissions reductions achieved to sunset (i.e., discontinue) CAIR and annual PM2.5 standard during the 2008– by CAIR, as sufficiently permanent and CAIR FIPs for control periods in 2012 2011 period. enforceable for regulatory purposes, and beyond. See 76 FR 48322. Although To the extent that Illinois is relying on such as redesignations. Following the Chicago area redesignation request CAIR in its maintenance plan to support promulgation of the replacement rule and Illinois’ PM2.5 maintenance plan continued attainment into the future, for CSAPR, EPA will review existing rely on emission reductions associated the recent directive from the D.C. SIPs as appropriate to identify whether with CAIR, EPA is proposing to approve Circuit in EME Homer City ensures that there are any issues that need to be the redesignation request and PM2.5 the emission reductions associated with addressed. maintenance plan based, in part, on the CAIR will be permanent and enforceable fact that CAIR is to remain in place until for the necessary time period. EPA has b. Maintenance Plan Precursor it is replaced by an acceptable interstate been ordered by the Court to develop a Evaluation Resulting From Court transport control rule. new rule to address interstate transport Decisions On December 30, 2011, the D.C. to replace CSAPR and the opinion In this proposal EPA is also Circuit issued an order addressing the makes clear that after promulgating that considering the impact of the D.C. status of CSAPR and CAIR in response new rule EPA must provide states an Circuit Court’s decision in Natural to motions filed by numerous parties opportunity to draft and submit SIPs to Resources Defense Council v. EPA, 706 seeking a stay of CSAPR pending implement that rule. Thus, CAIR will F.3d 428 (D.C. Cir. 2013), on the judicial review. In that order, the Court remain in place until EPA has maintenance plan required under stayed CSAPR pending resolution of the promulgated a final rule through a sections 175A and 107(d)(3)(E)(iv) of the petitions for review of that rule in EME notice-and- comment rulemaking CAA. EPA believes that the only Homer City (No. 11–1302 and process, states have had an opportunity additional consideration related to the consolidated cases). The Court also to draft and submit SIPs in response to maintenance plan requirements that indicated that EPA was expected to it, EPA has reviewed the SIPs to results from the D.C. Circuit Court’s continue to administer CAIR in the determine if they can be approved, and decision is that of assessing the interim until judicial review of CSAPR EPA has taken action on the SIPs, potential role of VOC and ammonia in was completed. including promulgating FIPs if demonstrating continued maintenance As discussed above, on August 21, appropriate. The Court’s clear in this area. Based on documentation 2012, the D.C. Circuit issued the instruction to EPA is that it must provided by the state and supporting decision in EME Homer City to vacate continue to administer CAIR until a information, EPA believes that the and remand CSAPR and ordered EPA to valid replacement exists, and thus EPA maintenance plan for the Chicago area

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need not include any additional projected out to 2020, there is no reason unexpectedly between 2020 and 2025, emission reductions of VOC or ammonia to believe that these downward trends the overall emission reductions in order to provide for continued would not continue through 2025. projected in SO2, NOX, primary PM2.5, maintenance of the standard. Given that the Chicago-Gary-Lake and VOC would be sufficient to offset Emissions inventories used in the County, IL–IN area is already attaining the increase in annual PM2.5 Regulatory Impact Analysis (RIA) (EPA– the 1997 annual PM2.5 standard, even concentrations resulting from the 452/R–12–005, December 2012) for the with the current levels of VOC and increase in ammonia emissions. For 2012 PM2.5 NAAQS show that VOC and ammonia emissions in the Chicago area, these reasons, EPA believes that local ammonia emissions in the Chicago area the downward trends in VOC and ammonia (and VOC) emissions will not are projected to decrease by 59,126 TPY ammonia would be consistent with increase to the extent that they will and 583 TPY, respectively between 2007 continued attainment of the 1997 cause monitored PM2.5 levels to violate and 2020. See table 11 below. While the annual PM2.5 standard. Even if ammonia the 1997 annual PM2.5 standard during RIA emissions inventories are only emissions were to increase the maintenance period.

TABLE 11—COMPARISON OF 2007 AND 2020 VOC AND AMMONIA EMISSIONS TOTALS BY SOURCE SECTOR (TPY) FOR THE CHICAGO AREA BASED ON RIA EMISSIONS ESTIMATES FOR THE 2012 PM2.5 NAAQS

VOC Ammonia Source sector Net change Net change 2007 2020 2007–2020 2007 2020 2007–2020

Fires ...... 442 442 0 31 31 0 Area ...... 109,052 107,202 ¥1,850 8,865 9,135 270 Non-Road Mobile ...... 46,784 25,007 ¥21,777 58 71 13 On-Road Mobile ...... 53,688 19,133 ¥34,555 2,525 1,363 ¥1,162 Point ...... 16,101 15,157 ¥944 332 628 296 Totals ...... 226,067 166,941 ¥59,126 11,811 11,228 ¥583

E. Has Illinois adopted acceptable redesignation request and maintenance margins’’ (see discussion below) for the MVEBs for the PM2.5 maintenance plan provide MVEBs, conformance with Chicago area. Table 12 also shows the period? which will assure that motor vehicle estimated 2008 and 2025 mobile source emissions are at or below levels that can emissions for the Chicago area. Illinois 1. How are MVEBs developed and what be expected to provide for attainment did not provide MVEBs for SO because are the MVEBs for the Chicago area? 2 and maintenance of the 1997 annual it concluded, consistent with EPA’s Under section 176(c) of the CAA, PM2.5 standard. Illinois’ redesignation presumptions regarding this PM2.5 transportation plans and Transportation request includes mobile source emission precursor, that emissions of this Improvement Programs (TIPs) must be budgets for NOX and primary PM2.5 for pollutant from motor vehicles are not evaluated for conformity with SIPs. 2008 and 2025. Table 12 shows the 2008 significant contributors to the Chicago Consequently, Illinois’s PM2.5 and 2025 MVEBs and 2025 ‘‘safety area’s PM2.5 air quality problem.

TABLE 12—2008 AND 2025 MOTOR VEHICLE EMISSION BUDGETS FOR THE CHICAGO AREA [TPY]

Estimated emissions Safety margin Motor vehicle emission budgets Year Primary Primary NOX NOX Primary PM2.5 PM2.5 NOX PM2.5

2008 ...... 5,100 127,951 — — 5,100 127,951 2025 ...... 2,067 38,456 310 5,768 2,377 44,224

Table 12 shows substantial decreases MVEBs are adequate for use in from all sources of a given pollutant are in on-road mobile source NOX and transportation conformity less than the total emissions which primary PM2.5 emissions from 2008 to determinations and are approvable would satisfy the applicable 2025. These emission reductions are because, when considered together with requirement for reasonable further expected because newer vehicles subject the submitted maintenance plan’s progress, attainment, or maintenance or to more stringent emission standards are projected emissions, they provide for a portion thereof (40 CFR 93.124(a)). continually replacing older, higher maintenance of the 1997 annual PM2.5 The safety margins selected by IEPA emitting vehicles. EPA is proposing to standard in the Chicago-Gary-Lake would provide for a 15 percent increase approve the 2008 and 2025 MVEBs for County, IL–IN area. in mobile source emissions for 2025 the Chicago area into the SIP because, 2. What are safety margins? above projected levels of these based on our review of the submitted emissions. These safety margins are PM2.5 maintenance plan, we have As noted in table 12, Illinois has acceptable under EPA’s transportation determined that the maintenance plan included safety margins in the 2025 conformity requirements because they and MVEBs meet EPA’s criteria found in MVEBs. A safety margin is the amount would not cause the total emissions in 40 CFR 93.118(e)(4) for determining that by which the total projected emissions

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the Chicago area to exceed the EPA’s ‘‘Emissions Inventory Guidance commodity sales estimates. The attainment year levels. for Implementation of Ozone and emission estimation techniques for each Particulate Matter National Ambient Air source category are thoroughly F. Are the 2002 base year PM -related 2.5 Quality Standards (NAAQS) and documented in the June 2006 document. emissions inventories for the Chicago Regional Haze Regulations’’ (August The June 2006 document estimates the area approvable under section 172(c)(3) 2005, EPA–454/R–05–001). Finally, a of the CAA? county-specific emissions by pollutant November 18, 2002 policy and by source type. Section 172(c)(3) of the CAA requires memorandum titled ‘‘2002 Base Year As discussed above, IEPA used EPA’s states to submit a comprehensive, Emission Inventory SIP Planning: 8-hr NONROAD model to estimate 2002 off- accurate, and current inventory of Ozone, PM2.5 and Regional Haze road mobile source emissions for all emissions for nonattainment areas. For Programs’’ recommends that the PM2.5- non-road mobile source types except: (1) PM2.5 nonattainment areas, states have based emissions inventory be developed Railroad locomotives; (2) aircraft typically submitted primary PM2.5, SO2, for a base year of 2002. It is noted that operations (including aircraft auxiliary and NOX emission inventories covering IEPA has generally followed all of these power units, landings, takeoffs, and one of the years of the three-year period guidelines in the development of the other aircraft operating modes); and, (3) used to determine the nonattainment base year emissions inventory for the commercial marine vessels. For the status of an area. For the 1997 annual PM2.5 SIP. three source types not covered by PM2.5 standard, the annual PM2.5 2. 2002 Base Year PM2.5-Related NONROAD modeling, Illinois obtained concentrations for the years of 2001– source activity data and emissions from 2003 were used to establish the Emission Inventories for the Chicago Area the Lake Michigan Air Directors nonattainment status of areas. Illinois Consortium, who contracted with Illinois documented the 2002 primary chose to submit PM2.5 emissions for several consultants to derive emissions PM , NO , SO , VOC, ammonia, and 2002 for purposes of meeting the 2.5 X 2 specific to the Chicago, Metro-East St. CO emissions in a June 2006 document requirements of section 172(c)(3) of the Louis and remaining areas in the state titled ‘‘Illinois Base Year Particulate CAA. Illinois documented these of Illinois. emissions and submitted this Matter and Haze Inventory for 2002.’’ documentation to EPA in June 2006. This document covers emissions for the IEPA used emission factors generated entire state of Illinois, and summarizes from EPA’s MOBILE6 computer model 1. EPA’s Base Year Emissions Inventory the emissions by source type and major and VMT and vehicle speeds by SIP Policy roadway facility type (or functional source category for the PM2.5 EPA’s SIP policy for base year nonattainment areas of Chicago and class), freeway, arterial, etc., supplied emissions inventories for the 1997 Metro-East St. Louis. by the local planning agency (Chicago annual PM2.5 standard is specified in Emissions data for point, area, on- Area Transportation Study and IDOT for three policy statements. EPA’s main SIP road mobile, off-road mobile, and the Chicago area) to estimate 2002 on- requirements for a base year PM2.5- biogenic emission sources were road mobile source emissions. IEPA also related emissions inventory are developed for the 2002 emissions used vehicle age and type distribution specified in section II.K of EPA’s April inventories by the IEPA. The primary data supplied by IDOT. The vehicle 25, 2007 implementation rule for the sources of data for point sources were activity information was derived for 1997 annual PM2.5 standard (72 FR AERs submitted by individual source each county to allow the determination 20586, 20647). This rule requires the facilities and source permit files. The of emissions by county. IEPA summed base year emissions inventory to be June 2006 emissions document covers up VMT and vehicle emissions for each approved by the EPA as a SIP element in detail the derivation of emissions for month of 2002 to determine annual on- (72 FR 20647), and requires the each source type identified as a point road mobile source emissions by emissions inventory to cover the source. Table 3–1 (page 34) of Illinois’ county. All MOBILE6 inputs and VMT emissions of NOX, SO2, VOC, ammonia, June 2006 document includes the point levels were thoroughly documented. In and primary PM2.5 (72 FR 20648). The source emission totals by county for addition to on-road emissions, IEPA coverage of PM2.5 precursor emissions each of the PM2.5 nonattainment areas. also calculated stage II refueling and emissions of primary PM2.5 The Chicago area point source emission (refueling of vehicles) emissions for the (primary PM2.5 is also a precursor for totals are summarized in table 13 below. Chicago area. secondary PM2.5 formation through Area source emissions were generally Table 13 (taken from Table B–1 in atmospheric reactions) is required under derived by multiplying source category- Appendix B of IEPA’s June 2006 40 CFR part 51 subpart A and 40 CFR specific emission factors by certain document shows the 2002 primary 51.1008 (72 FR 20648). Detailed indicator levels of source activity PM2.5 and PM2.5 precursor emissions emissions inventory guidance for PM2.5 (source surrogates), such as county totals by major source category for the (and other pollutants) is contained in populations, employment estimates, and Chicago area.

TABLE 13—2002 FINE PARTICULATE AND PRECURSOR EMISSIONS FOR THE CHICAGO AREA (TPY) DOCUMENTED IN ILLINOIS’ JUNE 2006 PM2.5 EMISSIONS DOCUMENTATION

Soure type Ammonia NOX Primary PM2.5 SO2 VOC

Point Sources ...... 143.70 54,049.62 2,766.61 121,597.92 21,190.70 Area Sources...... 3,708.77 32,302.14 22,356.04 3,290.25 89,090.21 On-Road Mobile Sources ...... 5,986.95 167,619.73 3,070.58 3,850.04 59,599.97 Off-Road Mobile Sources ...... 46.29 87,426.24 4,834.30 3,742.62 53,272.30 Totals ...... 9,885.71 341,397.73 33,027.53 132,480.83 223,153.18

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After IEPA compiled the June 2006 of the Paperwork Reduction Act (44 DEPARTMENT OF DEFENSE document, IEPA revised the 2002 on- U.S.C. 3501 et seq.); road mobile source emissions using • Are certified as not having a GENERAL SERVICES EPA’s MOVES mobile source emissions significant economic impact on a ADMINISTRATION model. The derivation of the 2008 on- substantial number of small entities road mobile source emissions using under the Regulatory Flexibility Act (5 NATIONAL AERONAUTICS AND MOVES is documented in the August U.S.C. 601 et seq.); SPACE ADMINISTRATION 17, 2011, draft of IEPA’s maintenance • Do not contain any unfunded 48 CFR Part 42 plan for the Chicago area. In this same mandate or significantly or uniquely document, IEPA indicates that the 2002 affect small governments, as described [FAR Case 2012–028; Docket 2012–0028; base year on-road mobile source in the Unfunded Mandates Reform Act Sequence 1] emissions were recalculated using the of 1995 (Pub. L. 104–4); same techniques. The 2002 emissions RIN 9000–AM40 • Do not have Federalism (including the MOVES-based on-road Federal Acquisition Regulation; mobile source emissions) for the implications as specified in Executive Order 13132 (64 FR 43255, August 10, Contractor Comment Period, Past Chicago area are summarized in tables Performance Evaluations 3, 4, and 5 above. 1999); • We find that the state has thoroughly Are not economically significant AGENCY: Department of Defense (DoD), documented the 2002 emissions for regulatory actions based on health or General Services Administration (GSA), primary PM2.5 and PM2.5 precursors in safety risks subject to Executive Order and National Aeronautics and Space the Chicago area. We also find that 13045 (62 FR 19885, April 23, 1997); Administration (NASA). • Illinois has used acceptable techniques Are not significant regulatory ACTION: Proposed rule. and supporting information to derive actions subject to Executive Order these emissions. Therefore, we are 13211 (66 FR 28355, May 22, 2001); SUMMARY: DoD, GSA, and NASA are proposing to approve Illinois’ 2002 base • Are not subject to requirements of proposing to amend the Federal year emissions inventory for the Section 12(d) of the National Acquisition Regulation (FAR) to Chicago area for purposes of meeting the Technology Transfer and Advancement implement provisions of law limiting emission inventory requirements of Act of 1995 (15 U.S.C. 272 note) because the periods allowed for contractor section 172(c)(3) of the CAA. application of those requirements would comments on past performance be inconsistent with the CAA; and evaluations and making past VI. Statutory and Executive Order performance evaluations available to • Do not provide EPA with the Reviews source selection officials sooner. discretionary authority to address, as Under the CAA, redesignation of an appropriate, disproportionate human DATES: Interested parties should submit area to attainment and the health or environmental effects, using written comments to the Regulatory accompanying approval of a practicable and legally permissible Secretariat at one of the addressees maintenance plan under section methods, under Executive Order 12898 shown below on or before October 7, 107(d)(3)(E) are actions that affect the (59 FR 7629, February 16, 1994). 2013 to be considered in the formation status of a geographical area and do not of the final rule. In addition, this proposed rule does not impose any additional regulatory ADDRESSES: Submit comments in requirements on sources beyond those have tribal implications as specified by response to FAR Case 2012–028 by any imposed by state law. A redesignation to Executive Order 13175 (65 FR 67249, of the following methods: attainment does not in and of itself November 9, 2000), because a • Regulations.gov: http:// create any new requirements, but rather determination of attainment is an action www.regulations.gov. Submit comments results in the applicability of that affects the status of a geographical via the Federal eRulemaking portal by requirements contained in the CAA for area and does not impose any new searching for ‘‘FAR Case 2012–028’’. areas that have been redesignated to regulatory requirements on tribes, Select the link ‘‘Submit a Comment’’ attainment. Moreover, the Administrator impact any existing sources of air that corresponds with ‘‘FAR Case 2012– is required to approve a SIP submission pollution on tribal lands, nor impair the 028’’. Follow the instructions provided that complies with the provisions of the maintenance of ozone national ambient at the ‘‘Submit a Comment’’ screen. CAA and applicable Federal regulations. air quality standards in tribal lands. Please include your name, company 42 U.S.C. 7410(k); 40 CFR 52.02(a). List of Subjects name (if any), and ‘‘FAR Case 2012– Thus, in reviewing SIP submissions, 028’’ on your attached document. EPA’s role is to approve state choices, 40 CFR Part 52 • Fax: 202–501–4067. • provided that they meet the criteria of Environmental protection, Air Mail: General Services the CAA. Accordingly, these actions pollution control, Incorporation by Administration, Regulatory Secretariat merely propose to approve state law as reference, Intergovernmental relations, (MVCB), ATTN: Hada Flowers, 1800 F meeting Federal requirements and do Particulate matter. Street NW., 2nd Floor, Washington, DC not impose additional requirements 20405–0001. beyond those imposed by state law and 40 CFR Part 81 Instructions: Please submit comments only and cite FAR Case 2012–028, in all the CAA. For that reason, these Environmental protection, Air correspondence related to this case. All proposed actions: pollution control, National parks, • comments received will be posted Are not ‘‘significant regulatory Wilderness areas. actions’’ subject to review by the Office without change to http:// of Management and Budget under Dated: July 22, 2013. www.regulations.gov, including any Executive Order 12866 (58 FR 51735, Susan Hedman, personal and/or business confidential October 4, 1993); Regional Administrator, Region 5. information provided. • Do not impose an information [FR Doc. 2013–18948 Filed 8–6–13; 8:45 am] FOR FURTHER INFORMATION CONTACT: Mr. collection burden under the provisions BILLING CODE 6560–50–P Curtis E. Glover, Sr., Procurement

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Analyst, at 202–501–1448, for selection officials immediately, so that retrospective plan, which promotes clarification of content. For information award decisions can be better informed public consultation and outreach, the pertaining to status or publication and made in a more timely manner. Councils would like to hear your schedules, contact the Regulatory Currently, however, FAR 42.1503(b) substantive comments on: how the Secretariat at 202–501–4755. Please cite provides ‘‘a minimum of 30 days’’ for expedient posting of these reports in the FAR Case 2012–028. contractor comments, rebutting system may impact your business; and SUPPLEMENTARY INFORMATION: statements, or additional information in ways to limit any extra burden, if any, response to the Government’s past this requirement is having on your I. Background performance evaluation, and the past business. DoD, GSA, and NASA are proposing performance evaluation is not made to amend the Federal Acquisition available until after the contractor’s III. Executive Orders 12866 and 13563 Regulation (FAR) to implement section comments have been made. This rule Executive Orders (E.O.s) 12866 and 853 of the National Defense proposes a change in contractors’ 13563 direct agencies to assess all costs Authorization Act (NDAA) for Fiscal response procedures. The statutes are and benefits of available regulatory Year (FY) 2013 (Pub. L. 112–239, clear: Contractors will have a maximum alternatives and, if regulation is enacted January 2, 2013) and section of 14 days to provide comments before necessary, to select regulatory 806 of the NDAA for FY 2012 (Pub. L. posting to PPIRS. In addition, the law approaches that maximize net benefits 112–81, enacted December 31, 2011, 10 now requires that past performance (including potential economic, U.S.C. 2302 Note). Section 853, entitled evaluations be available to source environmental, public health and safety ‘‘Inclusion of Data on Contractor selection officials not later than 14 days effects, distributive impacts, and Performance in Past Performance after the evaluation was provided to the equity). E.O. 13563 emphasizes the Databases for Executive Agency Source contractor, whether or not contractor importance of quantifying both costs Selection Decisions’’, and section 806, comments have been received. This is and benefits, of reducing costs, of entitled ‘‘Inclusion of Data on likely to serve as an impetus to harmonizing rules, and of promoting Contractor Performance in Past contractors to meet the 14 calendar flexibility. This is a significant Performance Databases for Source day’s deadline for comments. Having a regulatory action and, therefore, was Selection Decisions’’, require revisions past performance evaluation, with the subject to review under section 6(b) of to the acquisition regulations on past contractor’s comments and explanations E.O. 12866, Regulatory Planning and performance evaluations so that included, available to source selection Review, dated September 30, 1993. This contractors are provided ‘‘up to 14 officials within 14 days will be to the rule is not a major rule under 5 U.S.C. calendar days . . . from the date of advantage of most contractors. These 804. delivery’’ of past performance timely evaluations will allow evaluations ‘‘to submit comments, contractors who are meeting their IV. Regulatory Flexibility Act rebuttals, or additional information contractual obligations to be more DoD, GSA, and NASA do not expect pertaining to past performance’’ for competitive for future awards. this proposed rule to have a significant inclusion in the database. In addition, When a contractor is unable to economic impact on a substantial paragraph (c) of both sections 853 and provide comments within 14 days, number of small entities within the 806 requires that agency evaluations of however, the proposed changes to meaning of the Regulatory Flexibility contractor performance, including any CPARS and PPIRS will enable the Act, 5 U.S.C. 601, et seq., because information submitted by contractors, contractor’s comments to be added to contractor comments on their past be ‘‘included in the relevant past the past performance evaluation after performance evaluations are already performance database not later than the the evaluation has been moved into allowed by FAR subpart 42.15. date that is 14 days after the date of PPIRS. In addition, the planned system However, an Initial Regulatory delivery of the information’’ (section changes will allow the Government to Flexibility Analysis (IRFA) has been 853(c)) to the contractor. revise a past performance evaluation in prepared and is summarized as follows: PPIRS if the Government determines, The analysis is summarized as II. Discussion and Analysis after the 14-day period has expired, that follows: The FAR addresses Governmentwide corrections should be made to the past Section 806 of the National Defense rules for past performance evaluations performance evaluation. This rule Authorization Act (NDAA) for Fiscal Year at FAR subpart 42.15, Contractor proposes to amend FAR 42.1503(d) and 2012 (Pub. L. 112–81, enacted December 31, Performance Information. The (f). 2011), is entitled ‘‘Inclusion of Data on Contractor Performance Assessment OFPP has issued guidance and is Contractor Performance in Past Performance Reporting System (CPARS) processes working with agencies to improve their Databases for Source Selection Decisions’’. the assessment and provides it to the past performance reporting compliance Paragraph (c) of section 806 mandates Past Performance Information Retrieval to ensure this valuable performance DFARS revisions so that contractors are System (PPIRS), so agency source information is shared with source provided ‘‘up to 14 calendar days from the date of delivery’’ to them of past performance selection officials can review the selection officials. Timely reporting of evaluations ‘‘to submit comments, rebuttals, reports. CPARS provides an automatic this information will be crucial to the or additional information pertaining to past notification to the contractor when a successful implementation of this performance’’ for inclusion in the database. past performance evaluation has been regulation. Expediting the time allotted In addition, section 806(c) requires that DoD submitted to the system and is available to contractors to respond to performance agency evaluations of contractor for contractor comment. This is the evaluations should improve performance, including any information equivalent of ‘‘providing’’ the past communication between the contractor submitted by contractors, be ‘‘included in the performance evaluation to the and the Government, enable current relevant past performance database not later than 14 days after the date of delivery of the contractor, and it starts the suspense information to be shared quickly information’’ to the contractor. period for contractor comment or throughout the Government, and Section 853 of the NDAA for FY 2013 (Pub. rebuttal. ultimately ensure the Government does L. 112–239, enacted January 2, 2013) is It is important for past performance business with high performing entitled ‘‘Inclusion of Data on Contractor information to be shared with source contractors. In keeping with the FAR Performance in Past Performance Databases

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for Executive Agency Source Selection the proposed rule. The rule does not ■ 2. Amend section 42.1503 by revising Decisions’’, and it extends the requirements duplicate, overlap, or conflict with any other the third sentence in paragraph (d); and of section 806 to all Executive agencies. Federal rules. revising paragraph (f) to read as follows: The FAR addresses Governmentwide rules DoD, GSA, and NASA did not identify any for past performance evaluations at FAR alternatives that would comply with the 42.1503 Procedures. applicable statutes. The laws do not provide subpart 42.15, Contractor Performance * * * * * Information. The databases selected by the for any exemptions for small entities. (d) * * * Contractors shall be Office of Management and Budget (OMB) for The Regulatory Secretariat has these evaluations are the Contractor afforded up to 14 calendar days from the Performance Assessment Reporting System submitted a copy of the IRFA to the date of notification of availability of the (CPARS) and the Past Performance Chief Counsel for Advocacy of the Small past performance evaluation to submit Information Retrieval System (PPIRS). Business Administration. A copy of the comments, rebutting statements, or CPARS provides an automatic notification to IRFA may be obtained from the additional information. * * * the contractor when a past performance Regulatory Secretariat. DoD, GSA, and * * * * * evaluation has been submitted to the system NASA invite comments from small (f) Agencies shall prepare and submit and is available for contractor comment. This business concerns and other interested all past performance evaluations is the equivalent of ‘‘providing’’ the past parties on the expected impact of this electronically in the CPARS at http:// performance evaluation to the contractor, and rule on small entities. it starts the 14 day suspense period for DoD, GSA, and NASA will also www.cpars.gov. These evaluations, contractor comment or rebuttal. CPARS consider comments from small entities including any contractor-submitted processes the assessment and provides it to information (with indication whether PPIRS. concerning the existing regulations in subparts affected by this rule in agency review is pending), are The rule proposes a change in contractors’ automatically transmitted to PPIRS at response procedures. Instead of allowing ‘‘at consistent with 5 U.S.C. 610. Interested least 30 days’’ for a contractor’s response to parties must submit such comments http://www.ppirs.gov not later than 14 the past performance evaluation, contractors separately and should cite 5 U.S.C. 610 days after the date on which the will have a maximum of 14 days to do so. (FAR case 2012–028) in contractor is notified of the evaluation’s In addition, the statute now requires that past correspondence. availability for comment. The performance evaluations be available to Government shall update PPIRS with source selection officials not later than 14 V. Paperwork Reduction Act any contractor comments provided after days after the evaluation was provided to the This rule affects the certification and 14 days, as well as any subsequent contractor, whether or not contractor information collection requirements in agency review of comments received. comments have been received. However, the Past performance evaluations for proposed changes to the systems will enable the provision at FAR subpart 42.15, a contractor’s comments to be added to the currently approved under the OMB classified contracts and special access past performance evaluation after the Control Number 9000–0142, titled, Past programs shall not be reported in evaluation has been moved into PPIRS; these Performance Information; in the amount CPARS, but will be reported as stated in changes will also allow the Government to of 1,200,000 hours, in accordance with this subpart and in accordance with revise a past performance evaluation in the Paperwork Reduction Act (44 U.S.C. agency procedures. Agencies shall PPIRS if the Government determines, after chapter 35). This rule would shorten the ensure that appropriate management the 14 day period has expired, that it was in contractors’ response time, but it would and technical controls are in place to error. not expand the reporting requirement. ensure that only authorized personnel The proposed rule would apply to all small have access to the data and the businesses for which past performance The impact, however, is negligible evaluations are completed. OMB Control because contractors are already allowed information safeguarded in accordance Number 9000–0142, renewed in 2012, is the to submit comments, rebutting with 42.1503(d). source for the data used in this IRFA. It statements, or additional information * * * * * indicates that an estimated 150,000 regarding agency evaluations of their [FR Doc. 2013–18955 Filed 8–6–13; 8:45 am] respondents submit an average of four performance. The number of contractors BILLING CODE 6820–EP–P responses annually, for a total of 600,000 providing comments will be unaffected responses. Data from the Federal by this rule. Further, the type of Procurement Data System (FPDS) for Fiscal Year 2011 show that approximately 32 information provided is not impacted by DEPARTMENT OF TRANSPORTATION percent of the relevant actions of the this proposed rule. Federal Motor Carrier Safety responses are from small businesses, so this List of Subject in 48 CFR Part 42 rule would apply to approximately 48,000 Administration small entities. Government procurement. The requirement to conduct past Dated: July 31, 2013. 49 CFR Parts 392 and 396 performance evaluations is not new. The William Clark, differences between the current FAR past [Docket No. FMCSA–2012–0336] Acting Director, Office of Government-wide performance evaluation requirements (see RIN 2126–AB46 FAR subpart 42.15) and this proposed rule Acquisition Policy, Office of Acquisition Policy, Office of Government-wide Policy. are that the law reduces the time allowed for Inspection, Repair, and Maintenance; a contractor to submit comments, rebuttals, Therefore, DoD, GSA, and NASA Driver-Vehicle Inspection Report or additional information pertaining to past propose amending 48 CFR part 42 as set performance for inclusion in the past forth below: AGENCY: Federal Motor Carrier Safety performance database from ‘‘a minimum of Administration (FMCSA), DOT. 30 days’’ (FAR 42.1503(b)) to ‘‘up to 14 PART 42—CONTRACT ACTION: Notice of proposed rulemaking calendar days’’, and the law now requires ADMINISTRATION AND AUDIT that past performance evaluations be (NPRM). available to source selection officials not later SERVICES SUMMARY: FMCSA proposes to rescind than 14 days after the evaluation was ■ 1. The authority citation for 48 CFR provided to the contractor, whether or not the requirement that commercial motor contractor comments have been received. part 42 is revised to read as follows: vehicle (CMV) drivers operating in There are no new reporting, recordkeeping, Authority: 40 U.S.C. 121(c); 10 U.S.C. interstate commerce, except drivers of or other compliance requirements created by chapter 137; and 51 U.S.C. 20113. passenger-carrying CMVs, submit, and

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motor carriers retain, driver-vehicle applies, and provide a reason for each association, business, labor union, etc.). inspection reports when the driver has suggestion or recommendation. You You may review DOT’s complete neither found nor been made aware of may submit your comments and Privacy Act Statement in the Federal any vehicle defects or deficiencies. This material online or by fax, mail, or hand Register published on January 17, 2008 proposed rule would remove a delivery, but please use only one of (73 FR 3316), or you may visit http:// significant information collection these means. FMCSA recommends that edocket.access.gpo.gov/2008/pdf/E8- burden without adversely impacting you include your name and a mailing 785.pdf. safety. This proposed rule responds in address, an email address, or a phone part to the President’s January 2011 number in the body of your document Executive Summary Regulatory Review and Reform so the Agency can contact you if it has Purpose and Summary of the Major initiative. Finally, this proposed rule questions regarding your submission. Provisions harmonizes the pre- and post-trip To submit your comment online, go to inspection lists. http://www.regulations.gov and click on FMCSA proposes to rescind the DATES: You must submit comments on the ‘‘Submit a Comment’’ box, which requirement that commercial motor or before October 7, 2013. will then become highlighted in blue. In vehicle (CMV) drivers operating in the ‘‘Document Type’’ drop down menu, ADDRESSES: You may submit comments interstate commerce, except drivers of select ‘‘Rules,’’ insert ‘‘FMCSA–2012– identified by docket number FMCSA– passenger-carrying CMVs, submit, and 0336’’ in the ‘‘Keyword’’ box, and click 2012–0336 using any one of the motor carriers retain, driver-vehicle ‘‘Search.’’ When the new screen following methods: inspection reports (DVIR) when the • Federal eRulemaking Portal: http:// appears, click on ‘‘Submit a Comment’’ driver has neither found nor been made www.regulations.gov. in the ‘‘Actions’’ column. If you submit aware of any vehicle defects or • Fax: 202–493–2251. your comments by mail or hand deficiencies (no-defect DVIR). This • Mail: Docket Management Facility delivery, submit them in an unbound proposed rule would remove a 1 (M–30), U.S. Department of format, no larger than 8 ⁄2 by 11 inches, significant information collection Transportation, West Building Ground suitable for copying and electronic burden without adversely impacting Floor, Room W12–140, 1200 New Jersey filing. If you submit comments by mail safety. This proposed rule responds, in Avenue SE., Washington, DC 20590– and would like to know that they part, to the President’s January 2012 0001. reached the facility, please enclose a Regulatory Review and Reform stamped, self-addressed postcard or • Hand delivery: Same as mail initiative. Finally, this proposed rule address above, between 9 a.m. and 5 envelope. FMCSA will consider all comments harmonizes the pre- and post-trip p.m., e.t., Monday through Friday, inspection lists. except Federal holidays. The telephone and material received during the number is 202–366–9329. comment period and may change this Benefits and Costs To avoid duplication, please use only proposed rule based on your comments. This rule would affect all motor one of these four methods. See the Viewing Comments and Documents ‘‘Public Participation and Request for carriers currently subject to 49 CFR To view comments, as well as Comments’’ heading under the 396.11, both private and for-hire, with documents mentioned in this preamble SUPPLEMENTARY INFORMATION section the exception of operators of passenger- as being available in the docket, go to below for instructions on submitting carrying CMVs. Current safety http://www.regulations.gov and click on comments. regulations require drivers employed by the ‘‘Read Comments’’ box in the upper motor carriers to report any vehicle FOR FURTHER INFORMATION CONTACT: If right hand side of the screen. Then, in defects in need of repair noted during you have questions on this proposed the ‘‘Keyword’’ box, insert ‘‘FMCSA– the course of a driving day on the DVIR. rule, call or email Mrs. Deborah Freund, 2012–0336’’ and click ‘‘Search.’’ Next, This report must be submitted to the Vehicle and Roadside Operations click ‘‘Open Docket Folder’’ in the employing motor carrier so that repairs Division, Office of Bus and Truck ‘‘Actions’’ column. Finally, in the can be made. Regulations now require Standards and Operations, Federal ‘‘Title’’ column, click on the document drivers to file the no-defect DVIR at the Motor Carrier Safety Administration, you would like to review. If you do not end of each tour of duty, even if there telephone: 202–366–5541; have access to the Internet, you may are no vehicle defects to report. The [email protected]. If you have view the docket online by visiting the proposed rule would eliminate the need questions on viewing or submitting Docket Management Facility in Room to file a no-defect DVIR, except for material to the docket, call Renee V. W12–140 on the ground floor of the operations involving passenger-carrying Wright, Program Manager, Docket DOT West Building, 1200 New Jersey CMVs. Operations, telephone 202–366–9826. Avenue SE., Washington, DC 20590, SUPPLEMENTARY INFORMATION: between 9 a.m. and 5 p.m., e.t., Monday The no-defect DVIR imposes a through Friday, except Federal holidays. substantial time and paperwork burden Public Participation and Request for on the industry, with no discernible Comments Privacy Act social benefit. The Agency estimates FMCSA encourages you to participate All comments received will be posted that non-passenger-carrying CMV in this rulemaking by submitting without change to http:// drivers spend approximately 47.2 comments and related materials. www.regulations.gov and will include million hours each year completing no- any personal information you have defect DVIRs, time which could be Submitting Comments provided. Anyone may search the dedicated to other purposes. FMCSA If you submit a comment, please electronic form of all comments estimates that the monetized value of include the docket number for this received into any of our dockets by the this time is currently $1.7 billion per rulemaking (FMCSA–2012–0336), name of the individual submitting the year, which is the estimated social indicate the specific section of this comment (or of the person signing the benefit that would result from the document to which each comment comment, if submitted on behalf of an adoption of the proposed rule.

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TABLE 1—SUMMARY OF THE MONETIZED SOCIAL BENEFITS, COSTS AND NET BENEFITS OF THE PROPOSED RULE

Annual 10 Years, 7 percent discount rate 10 Years, 3 percent discount rate

Monetized Benefits ...... $1.7 Billion ...... $12.8 Billion ...... $14.9 Billion Social Costs ...... $0 ...... $0 ...... $0 Net Benefits ...... $1.7 Billion ...... $12.8 Billion ...... $14.9 Billion

Background requirement to prepare a no-defect DVIR On March 31, 2010, the Ocean Carrier Presidential Executive Order (E.O.) has been in the safety regulations since Equipment Management Association 13563, ‘‘Improving Regulation and 1952 (17 FR 4422, 4452, May 15, 1952). (OCEMA) and Institute of International Regulatory Review’’ (issued January 18, In a separate report (54 M.C.C. 337, at Container Lessors (IICL) jointly filed a 2011, and published January 21 at 76 FR 356, April 14, 1952) the ICC explained petition for rulemaking to rescind the 3821), prompted DOT to publish a that it was revising its rule to improve part of § 390.42(b) that required drivers motor carriers’ inspection and notice in the Federal Register (76 FR to file no-defect DVIRs on IME they maintenance procedures and 8940, February 16, 2011). This notice return to IEPs. OCEMA and IICL recordkeeping. The ICC noted that the requested comments on a plan for requested that FMCSA delete the most substantial recordkeeping change reviewing existing rules, as well as sentence ‘‘if no damage, defects, or proposed and adopted was for the driver identification of existing rules that DOT deficiencies are discovered by the to complete the vehicle condition report should review because they may be driver, the report shall so indicate.’’ or trip ticket at the end of the day’s The petitioners presented four outmoded, ineffective, insufficient, or work or tour of duty whether or not any arguments supporting their request: excessively burdensome. DOT placed all defect or deficiency in the equipment is 1. Section 4118 of SAFETEA–LU retrospective regulatory review discovered, ‘‘. . . in order to provide a requires DVIRs only for known damage comments, including a transcript of a continuous record of vehicle condition or defects. Congress could have added a March 14, 2011, public meeting, in and to insure that the reports, requirement to file no-defect DVIRs but docket DOT–OST–2011–0025. DOT particularly those involving defects, will did not do so. received comments from 102 members be made out currently and maintained 2. There is significant risk that a large of the public, with many providing on a current basis.’’ volume of no-defect DVIRs could multiple suggestions. FMCSA received On December 17, 2008, FMCSA overwhelm the small proportion (4 one comment from the American published a final rule to implement percent) of DVIRs that contain damage Trucking Associations, Inc. concerning section 4118 of Safe, Accountable, or defects. what it considered duplicative driver Flexible, Efficient Transportation Equity 3. Data transmission, processing, and vehicle inspection requirements in 49 Act: A Legacy for Users (SAFETEA–LU) storage requirements for no-defect CFR Parts 392 and 396. Although [Pub. L. 109–59, 119 Stat. 1144, 1729, DVIRs could add significant FMCSA agrees that there is some Aug. 10, 2005], dealing with the safety unnecessary costs to intermodal duplication, the Agency does not of chassis used to transport intermodal operations without providing offsetting believe that it results in unnecessary containers (73 FR 76794). Among other benefits. actions or an information collection things, section 4118 called for the 4. Submission of no-defect DVIRs burden. However, FMCSA did discover Secretary to mandate ‘‘a process by contributes to driver productivity losses a related information collection burden which a driver or motor carrier in the form of congestion and delay at that it considers unnecessary and transporting intermodal equipment intermodal facilities. proposes to remove in this NPRM. [IME] is required to report to the On June 12, 2012 (77 FR 34846), the It has always been the responsibility intermodal equipment provider [IEP] or Agency published a final rule of a commercial motor vehicle (CMV) the providers’ designated agent any eliminating the requirement for drivers driver to report vehicle defects. In 1939, actual damage or defect in the operating IME to submit—and IEPs to the Interstate Commerce Commission intermodal equipment of which the retain—DVIRs when the driver has (ICC) issued regulations requiring every driver or motor carrier is aware at the neither found nor been made aware of driver to submit a written report on the time the intermodal equipment is any defects in the IME. condition of the vehicle at the end of his returned to the intermodal equipment The Agency now proposes to extend day’s work or tour of duty. At a provider or the provider’s designated this relief from the paperwork minimum, the report had to include agent’’ (49 U.S.C. 31151(a)(3)(L)). requirement to all interstate motor information about any vehicle defect or FMCSA’s 2008 rule included a new carriers subject to Part 396 of the deficiency the driver discovered that code section—49 CFR 390.42—which FMCSRs, except operators of passenger- would likely affect the safety of prescribed the responsibilities of drivers carrying CMVs. operation of that vehicle (4 FR 2294 at and motor carriers when operating IME. 2305, June 7, 1939). The ICC Section 390.42(b) required the driver or Legal Basis for the Rulemaking recommended, but did not require, that motor carrier to report any damage to or This proposed rule is based on the motor carriers use a ‘Driver’s Trip deficiencies in certain IME parts and authority of the Motor Carrier Act of Report,’ and it provided an example accessories at the time the equipment is 1935 (1935 Act) [49 U.S.C. 31502(b)] report format in its 1939 notice. The returned to the IEP. and the Motor Carrier Safety Act of 1984 example report included the driver’s Importantly, FMCSA did not propose (1984 Act) [49 U.S.C. 31136(a)], both of name, vehicle number, date, a list of 20 any changes to § 396.11(b), ‘‘Report which are broadly discretionary. items for inspection, and a space for the content,’’ which requires—both for IME The 1935 Act provides that the driver and mechanic to note defects. and non-IME—that ‘‘If no defect or Secretary of Transportation (Secretary) This report is now called a DVIR, but deficiency is discovered by or reported may prescribe requirements for the current rule does not include an to the driver, the report shall so • qualifications and maximum hours example of the report form. The indicate.’’ of service of employees of, and safety of

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operation and equipment of, a motor rule would eliminate only the part.’’ Section 396.3(a)(1) requires that carrier (§ 31502(b)(1)), and requirement for drivers (except drivers ‘‘[p]arts and accessories shall be in safe • qualifications and maximum hours of passenger-carrying CMVs) to prepare and proper operating condition at all of service of employees of, and reports when there are no defects or times.’’ Section 396.11(a) states that standards of equipment of, a motor deficiencies; it would keep in place the every motor carrier must ‘‘require its private carrier, when needed to promote rule requiring reports when there are drivers to report, and every driver shall safety of operation (§ 31502(b)(2)). defects or deficiencies, as well as the prepare a report in writing at the This rulemaking is based on the requirement for motor carriers to take completion of each day’s work on each Secretary’s authority under both appropriate action on receipt of the vehicle operated,’’ and that report shall § 31502(b)(1) and (2). report when problems with the vehicle cover a specific list of parts and The 1984 Act authorizes the Secretary are noted. Therefore, the removal of the accessories. Section 396.11(c) states that to regulate drivers, motor carriers, and requirement to prepare and retain no- ‘‘Prior to requiring or permitting a driver vehicle equipment. Section 31136(a) defect DVIRs would not compromise to operate a vehicle, every motor carrier requires the Secretary to publish drivers’ ability to report vehicle or its agent shall repair any defect or regulations on commercial motor problems to the carrier, or relieve deficiency listed on the driver vehicle vehicle (CMV) safety. Specifically, the carriers of the responsibility to take inspection report which would be likely Act sets forth minimum safety standards action. Furthermore, elimination of the to affect the safety of operation of a to ensure that: (1) CMVs are maintained, no-defect DVIRs would not compromise vehicle.’’ equipped, loaded, and operated safely drivers’ protection under existing (49 U.S.C. 31136(a)(1)); (2) the whistleblower statutes concerning FMCSA emphasizes that the Agency responsibilities imposed on operators of employers taking adverse action against is not foregoing the fundamental CMVs do not impair their ability to drivers for refusing to violate the requirements of Part 393, Parts and operate the vehicles safely (49 U.S.C. FMCSRs. The rule thus provides Accessories Necessary for Safe 31136(a)(2)); (3) the physical condition protection against coercion of drivers by Operation. Nor is it proposing to change of CMV operators is adequate to enable motor carriers. Finally, because the rule any other element of the inspection, them to operate the vehicles safely (49 would remove a regulatory burden repair, and maintenance requirements of U.S.C. 31136(a)(3)); and (4) the criticized by both drivers and motor Part 396. Drivers will still be required to operation of CMVs does not have a carriers (and irrelevant to shippers, perform pre-trip evaluations of deleterious effect on the physical receivers, and transportation equipment condition, and complete condition of the operators (49 U.S.C. intermediaries), there is virtually no DVIRs if any defects or deficiencies are 31136(a)(4)). Section 32911 of the possibility that a CMV operator would discovered or reported during the day’s Moving Ahead for Progress in the 21st be coerced to violate the rule itself. It is operations. Motor carriers will still be Century Act (MAP–21) [Pub. L. 112– true, of course, that a motor carrier required to have systematic inspection, 141, 126 Stat. 405, 818, July 6, 2012] could insist that a driver continue filing repair, and maintenance programs recently enacted a fifth requirement, i.e., no-defect DVIRs even in the absence of (including preventative maintenance) to ensure that ‘‘(5) an operator of a a regulatory requirement, but that would and maintain records to prove measures commercial motor vehicle is not coerced be a condition of employment, not are being taken to reduce to the extent by a motor carrier, shipper, receiver, or coercion to violate a safety regulation. practicable, the risk of mechanical transportation intermediary to operate a Agency Proposal problems happening while the vehicle commercial motor vehicle in violation is in operation. In addition, motor of a regulation promulgated under this The Agency is proposing to rescind, carriers will still be required to review section, or chapter 51 or chapter 313 of except for operators of certain driver vehicle inspections that list this title’’ (49 U.S.C. 31136(a)(5)). The passenger-carrying CMVs, the defects or deficiencies and take 1984 Act also grants the Secretary broad requirement in 49 CFR 396.11(b) appropriate action before the vehicle is power in carrying out motor carrier requiring CMV drivers to submit, and dispatched again. The Agency will safety statutes and regulations to motor carriers to retain, DVIRs when the retain the requirement for carriers to ‘‘prescribe recordkeeping and reporting driver has neither found nor been made complete periodic or annual requirements’’ and to ‘‘perform other aware of any vehicle defects or inspections, and maintain acts the Secretary considers deficiencies. documentation for the individuals who appropriate’’ (49 U.S.C. 31133(a)(8) and Drivers and motor carriers have long perform periodic inspections and (10)). been required to share the safety individuals responsible for performing This rule implements, in part, the responsibility for operating CMVs and brake-related inspection, repair, and Administrator’s authority under for assessing the condition of CMVs and maintenance tasks. Furthermore, these § 31136(a)(1) to ensure that CMVs are documenting deficiencies and repairs. CMVs will continue to be subject to maintained, equipped, loaded, and Section 392.7(a) states that ‘‘No roadside inspections. In short, the operated safely. The NPRM is also based commercial motor vehicle shall be existing regulations place shared on the broad recordkeeping and driven unless the driver is satisfied that responsibility on drivers and motor implementation authority of the following parts and accessories are carriers to ensure that CMVs used in § 31133(a)(8) and (10). This proposed in good working order . . .’’ Section interstate commerce are in safe and rule addresses only CMV equipment 393.1(b)(1) provides that ‘‘[e]very motor proper operating condition. This and reporting requirements. The carrier and its employee must be proposed rule does not change a driver’s provisions of the 1984 Act dealing with knowledgeable of and comply with the obligation to report on the condition of the physical condition of drivers requirements and specifications of this the CMVs and to report to the motor therefore do not apply (§ 31136(a)(3)– part,’’ and § 393.1(c) states that ‘‘No carrier any defects or deficiencies that (4)). Finally, as to ensuring that motor carrier may operate a commercial could affect the safety of its operation. operators of CMVs are not coerced by motor vehicle, or cause or permit such motor carriers, shippers, receivers, or vehicle to be operated, unless it is The Agency’s preferred alternative transportation intermediaries to ‘operate equipped in accordance with the would continue to require drivers of a CMV in violation of a regulation, the requirements and specifications of this passenger-carrying CMVs to prepare no-

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defect DVIRs.1 There are several reasons the National Transportation Safety whether eliminating the no-defect DVIR for this. Board has found that defects or would affect the condition and proper First, one of the fundamental deficiencies in vehicle condition were a maintenance of vehicle components. differences between passenger and root cause of several of the motorcoach However, due to data reporting freight operations is that motorcoach crashes it investigated which accounted limitations, it is impossible to drivers often need to interact with their for 20 percent of the fatalities. distinguish between form-and-manner passengers, particularly at the beginning At this time, and for these reasons violations and serious safety violations, and end of their work day, but often stated above, FMCSA does not propose e.g., between failing to sign a no-defect during the trip as well. These extending relief from the requirement DVIR and failing to report a known interactions are a critical part of a for drivers of passenger-carrying defect. However, given the motorcoach driver’s responsibilities and vehicles to complete and submit ‘‘no responsibility for vehicle inspection, may result in the driver overlooking or defect’’ DVIRs. The Agency requests repair, and maintenance currently failing to recall certain mechanical public comments on this issue, with an shared by drivers and motor carriers conditions unless the report is required emphasis on information and data (which will continue despite the every work day. The daily preparation concerning the mechanical condition of adoption of the proposed elimination of of the DVIR would reinforce the motorcoaches and other passenger- no-defect DVIRs), the Agency is importance of reporting vehicle carrying vehicles subject to FMCSA’s confident that there will be no reduction maintenance issues irrespective of the jurisdiction. Specifically, what in the overall level of equipment safety routine interactions with passengers at percentage of DVIRs currently prepared as a result of this proposed change. the beginning and end of the work day. by drivers of passenger-carrying Additionally, to increase safety and Also, because motorcoach drivers must vehicles include reports of vehicle harmonize regulatory text, FMCSA has be alert to the varying needs of their defects and deficiencies? Is the volume added two items to the pre-trip passengers, they may not be able to of DVIRs that include reports of inspection list in § 392.7. These items focus as closely as truck drivers on mechanical problems by drivers of are required to be included on a DVIR changes in their vehicle’s operating passenger-carrying vehicles so small and should be checked during the pre- condition encountered during a trip. that the processing of no-defect DVIRs trip inspection. These concerns underscore the could potentially result in the passenger FMCSA seeks comments from all importance of continuing to include the carriers overlooking the reports which interested parties on certain aspects of process of documenting vehicle require action? the DVIR process. condition as a consistent part of the For operators of passenger-carrying passenger-carrying driver’s daily vehicles, what percentage of the time do 1. DVIR Handling routine. drivers find that interactions with 1.1. Please explain in detail your Second, motorcoach crashes are low- passengers at the end of the work day procedures for filing and maintaining probability high-consequence events make it difficult to accurately recall DVIRs from the time they are completed with fatal and injury crashes occurring defects or deficiencies that were through the end of their retention relatively infrequently compared to observed or reported during the day, periods. Are defect DVIRs kept separate truck crashes, yet the potential for and document those mechanical from no-defect DVIRs, sent to significant numbers of injuries and problems on a DVIR? If FMCSA were to maintenance staff, and then acted on? fatalities being greater than that of truck eliminate the requirement for preparing Do you have special procedures in place crashes Based upon analysis of MCMIS a DVIR every day, would interaction for the no-defect DVIRs? If so, please data for the period 2007–2011, the with the passengers at the end of the describe them. average number of fatalities per fatal work day, combined with the as-needed 1.2. Do you have examples of specific truck-related crash was 1.13—but for preparation of DVIRs, increase the incidents in which handling a large cross-country/intercity buses the likelihood of drivers overlooking or volume of no-defect DVIRs has average number of fatalities was 1.57, forgetting to prepare a DVIR on those interfered with the handling of defect nearly 40 percent higher. While FMCSA occasions when something was wrong DVIRs? If so, please describe how these does not have data concerning with the vehicle? additional documents affected the motorcoach crashes attributable to the In summary, FMCSA is proposing to repairing of defects. mechanical condition of the vehicle, the eliminate the requirement for drivers of 1.3. Some DVIRs are completed Agency believes it is appropriate to property-carrying vehicles to submit, electronically. Are the electronic DVIRs consider this factor in the decision- and motor carriers to retain, no-defect automatically or manually separated making process and request public DVIRs. The Agency believes that into defect and no-defect categories? Do comment on this issue. removing the requirement for drivers of you have an estimate of the percentage Third, because they are carrying the property-carrying CMVs to complete a of forms filled out on paper and most valuable cargo, motor carriers of no-defect DVIR will not diminish CMV electronically? If so, please provide passengers must exercise heightened safety, and as discussed in greater detail detailed information on the data and diligence over their operations, in the Regulatory Analysis section of methodology used for that estimate. including CMV maintenance. As noted this NPRM, the proposed amendment 2. Please provide information on the in the Motorcoach Safety Action Plan,2 will significantly reduce the paperwork percentage of no-defect DVIRs. Also, burden to drivers and motor carriers. As please provide a discussion of the 1 Pursuant to 49 CFR 390.3(f)(6), this proposed noted in the Legal Basis section, this methodology for developing this rule would not apply to ‘[t]he operation of proposed rule would not preclude information. commercial motor vehicles designed or used to transport between 9 and 15 passengers (including motor carriers from continuing to 3. Should the FMCSA preserve an the driver), not for direct compensation, provided require their drivers to prepare no- inspection list in § 392.7 to assist the vehicle does not otherwise meet the definition defect DVIRs as a condition of drivers in conducting pre-trip of a commercial motor vehicle. employment. inspections? Or would drivers be 2 The U.S. Department of Transportation’s Motorcoach Safety Action Plan of 2012 is available FMCSA attempted to determine, sufficiently knowledgeable and at http://www.fmcsa.dot.gov/documents/safety- through an analysis of historical experienced at conducting pre-trip security/Motorcoach-Safety-Action-Plan-2012.pdf. inspection and other safety data, inspections that they would not have to

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rely on a regulation to prescribe the FMCSA has determined that this can be valued at $35 million per year essential vehicle components and proposed rule would have an annual (980,000 hours saved × $36 per hour). systems that should be checked before effect of $100 million or more. The (These annualized figures are the same each trip? To what extent do carriers value of the time saved by eliminating for both 7 and 3 percent discount rates.) and drivers rely on the list in § 392.7? the paperwork burden associated with The Agency’s proposed addition of 4. To what extent do carries and the filing of no-defect DVIRs is ‘‘wheels and rims’’ and ‘‘emergency drivers rely upon the list in § 396.11? approximately $1.7 billion per year. The equipment’’ to the items required to be Section Analysis explanation of how these savings were inspected under § 392.7 would make the derived is presented below. The lists in this section and § 396.11 In § 392.7, FMCSA proposes adding proposed rule is not expected to have consistent. The addition of these two ‘‘wheels and rims’’ and ‘‘emergency any negative safety impacts. If anything, items to § 392.7 is expected to impose equipment’’ to the pre-trip list in the rule may actually improve safety by a de minimis additional burden on paragraph (a) in order to harmonize it ensuring that the relatively few DVIRs drivers performing pre-trip evaluations with the post-trip list in § 396.11(a)(1). that report defects are not lost among of equipment, as drivers will be able to Additionally, FMCSA proposes to the vast majority of those that do not, readily observe whether these newly amend 49 CFR Part 396 by deleting the thereby making it easier for motor added items are in good working order sentence in § 396.11(b)(2) that reads ‘‘If carriers to identify vehicles in need of during their review of the items no defect or deficiency is discovered by repair. In addition, a no-defect report currently in the § 392.7 list (service or reported to the driver, the report shall could be taken as evidence by a new brakes, including trailer brake so indicate.’’ In its place, FMCSA would driver of a vehicle that a pre-trip connections, parking (hand) brake, insert ‘‘The driver of a passenger- inspection is unnecessary because the steering mechanism, lighting devices carrying CMV must prepare a report previous driver did not note any defects. and reflectors, tires, horn, windshield even if no defect or deficiency is Hence, no defect reports could provide wiper or wipers, rear-vision mirror or discovered by or reported to the driver; a false sense of security, tempting mirrors, and coupling devices). For the drivers of all other commercial drivers to skip the mandatory pre-trip example, a driver making a visual motor vehicles are not required to inspection. examination of tires can hardly avoid prepare a report if no defect or The Agency conducted an analysis examining the wheels and rims at the deficiency is discovered by or reported per the requirements of the Paperwork same time, and, defects on these to the driver.’’ FMCSA would also make Reduction Act (PRA) to estimate the components are usually fairly obvious. minor editorial and formatting changes reduction in hourly burden that the Similarly, while getting into the cab to to the remainder of the text of elimination of DVIRs for non-passenger- check the steering mechanism and horn, § 396.11(b)(2). carrying operators of CMVs. FMCSA he or she can easily glance at the dial Rulemaking Analyses determined that 46.7 million hours of gauge on the fire extinguisher to paperwork burden would be eliminated determine that it is still fully charged. Executive Order 12866 (Regulatory by this proposed rule. The full details of Other emergency equipment, including Planning and Review) as Supplemented the PRA analysis are included in the warning triangles, flares, or fuses are by E.O. 13563 and DOT Regulatory ‘‘Paperwork Reduction Act’’ section usually stored in an easy-to-reach Policies and Procedures below. Using a labor cost of $36 per location (often under or behind the Under E.O. 12866, ‘‘Regulatory hour, (using a base wage of $18.24,3 driver’s seat) and are readily checked. Planning and Review’’ (issued fringe benefits of 55 percent 4, and These items were added to the September 30, 1993, published October overhead of 27 percent 5) the Agency inspection list for consistency, and we 4 at 58 FR 51735), as supplemented by valued this time savings at $1.7 billion expect the cost and benefits of these E.O. 13563 (discussed above in the per year (46.7 million hours saved × $36 additions to be de minimis. ‘‘Background’’ section), and DOT per hour). If passenger-carrying CMV policies and procedures, FMCSA must drivers were allowed to stop producing Regulatory Flexibility Act determine whether a regulatory action is no defect DVIRs, an additional 980,000 The Regulatory Flexibility Act of 1980 ‘‘significant’’ and therefore subject to burden hours would be saved, which (5 U.S.C. 601 et seq.) requires Federal OMB review. E.O. 12866 defines agencies to consider the effects of a ‘‘significant regulatory action’’ as one 3 The median hourly wage for heavy truck regulatory action on small business and likely to result in a rule that may: drivers. See http://www.bls.gov/oes/current/ other small entities and to minimize any (1) Have an annual effect on the oes533032.htm. Accessed March 7, 2013. significant economic impact. The term 4 economy of $100 million or more or The ratio of total fringe benefits to wages and ‘‘small entities’’ comprises small adversely affect in a material way the salaries for transportation and warehousing workers. See http://www.bls.gov/news.release/ businesses and not-for-profit economy, a sector of the economy, archives/ecec_06072012.pdf. Table 10, Employer organizations that are independently productivity, competition, jobs, the costs per hour worked for employee compensation owned and operated and are not environment, public health or safety, or and costs as a percent of total compensation: Private dominant in their fields, and State, local, or Tribal government or industry workers, by industry group, March 2012. Transportation and Warehousing. http:// governmental jurisdictions with a communities. www.bls.gov/news.release/pdf/ecec.pdf. Accessed population of less than 50,000.6 (2) Create a serious inconsistency or March 7, 2013. Accordingly, DOT policy requires an otherwise interfere with an action taken 5 Industry data gathered for the Truck Costing analysis of the impact of all regulations or planned by another Agency. Model developed by the Upper Great Plains on small entities, and mandates that (3) Materially alter the budgetary Transportation Institute Berwick showed an average cost of $0.107 per mile of CMV operation for agencies try to minimize any adverse impact of entitlements, grants, user fees, management and overhead, and $0.39 per mile for effects on these entities. Under the or loan programs or the rights and labor, indicating an overhead rate of 27 percent ÷ Regulatory Flexibility Act, as amended obligations of recipients thereof. ($0.107 $0.39). See Farooq. ‘‘Truck Costing Model by the Small Business Regulatory (4) Raise novel legal or policy issues for Transportation Managers’’. Upper Great Plains Transportation Institute, North Dakota State arising out of legal mandates, the University (2003) accessed on June 18, 2012 at 6 Regulatory Flexibility Act (5 U.S.C. 601 et seq.), President’s priorities, or the principles http://ntl.bts.gov/lib/24000/24200/24223/ see National Archives at http://www.archives.gov/ set forth in the E.O. 24223.pdf. See Appendix A, pp. 42–47. federal-register/laws/regulaotry-flexibility/601.html.

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Enforcement Fairness Act of 1996 on the broad recordkeeping and (4) A Description of the Projected (SBREFA) (Pub. L. 104–121, 110 Stat. implementation authority of Reporting, Recordkeeping, and Other 857), the proposed rule is expected to § 31133(a)(8) and (10). As a result, the Compliance Requirements of the have a significant economic impact on removal of the obligation to prepare and Proposed Rule, Including an Estimate of a substantial number of small entities in retain no-defect DVIRs would not the Classes of Small Entities That the form of cost savings through the compromise drivers’ ability to report Would be Subject to Requirements and elimination 46 million paperwork vehicle problems to the carrier, or the Type of Professional Skills burden hours. These firms would relieve carriers of the responsibility to Necessary for Preparation of the Report receive regulatory relief of take action. or Record approximately $3,000 per entity, which (3) A Description of and, Where This rule would reduce costs on small is a positive benefit and does not Feasible, an Estimate of the Number of entities by eliminating a substantial impose a cost on the regulated entities. Small Entities to Which the Proposed paperwork filing burden. The reduction See 5 U.S.C. 605(b). Rule Would Apply in this burden is estimated to save the FMCSA invites comment from industry 46.7 million hours of driver members of the public who believe Generally, motor carriers are currently time with associated monetized savings there will be a significant impact either not required to report their annual of $1.7 billion, as explained in the on small businesses or on governmental revenue to the Agency, but all carriers Paperwork Reduction Act section. These jurisdictions with a population of less are required to provide the Agency with benefits would accrue primarily to small than 50,000. An Initial Regulatory the number of power units (PUs) they carriers that make up the majority of Flexibility Analysis (IRFA) must operate when they apply for operating firms and employ the majority of drivers include six elements. authority and to update this figure in the industry. The skills for drivers to biennially. Because FMCSA does not Initial Regulatory Flexibility Analysis complete DVIRs are basic reading and have direct revenues figures, PUs serve (IRFA) writing proficiency skills. as a proxy to determine the carrier size (1) A Description of the Reason Why that would qualify as a small business (5) Identification, to the Extent Action by the Agency Is Being given the Small Business Practicable, of all Relevant Federal Considered Administration (SBA) prescribed Rules Which May Duplicate, Overlap, or Conflict With the Proposed Rule FMCSA proposes to rescind the revenue threshold. In order to produce requirement that commercial motor this estimate, it is necessary to This proposed rule does not duplicate, overlap, or conflict with any vehicle (CMV) drivers operating in determine the average annual revenue Federal rules. This rule responds in part interstate commerce, except drivers of generated by a single PU. to the President’s January 2012 passenger-carrying CMVs, submit, and With regards to truck power units Regulatory Review and Reform motor carriers retain, driver-vehicle (PUs), the Agency determined in the 7 initiative. inspection reports (DVIR) when the 2003 Hours of Service Rulemaking RIA driver has neither found nor been made that a PU produces about $172,000 in (6) A Description of any Significant aware of any vehicle defects or revenue annually (adjusted for Alternatives to the Proposed Rules deficiencies (no-defect DVIR). This inflation).8 This equates to 148 PUs Which Accomplish the Stated proposed rule would remove a ($25,000,000/$172,000). Thus FMCSA Objectives of Applicable Statutes and significant information collection considers motor carriers with 148 PUs Which Minimize any Significant burden without adversely impacting or fewer to be a small business for SBA Economic Impact of the Proposed Rule safety. This proposed rule responds, in purposes. The results show that 99.1 on Small Entities percent of all carriers with recent part, to the President’s January 2011 The Agency has concluded that there activity have 148 PUs or fewer.9 This Regulatory Review and Reform are no significant alternatives to the amounts to 516,294 10 interstate freight initiative. Finally, this proposed rule proposed rule that would achieve either and passenger carriers that are would harmonize the pre- and post-trip the value of $1.7 billion in time savings considered small, with annual receipts inspection lists. or objectives of this proposal, from the of less than $25.5 million. The SBA eliminating the paperwork burden. (2) A Succinct Statement of the defines a ‘‘small entity’’ in the truck Because small businesses are such a Objectives of, and Legal Basis Why transportation subsector (North considerable part of the demographic Action by the Agency Is Being American Industry Classification the Agency regulates, providing Considered System (NAICS) 484) as an entity with alternatives to small businesses for non- The objective of the NPRM is to grant annual revenue of less than $25.5 compliance options is neither feasible regulatory relief to motor carriers and million (13 CFR 121.201).11 nor consistent with public safety. drivers of all sizes of vehicles currently subject to 49 CFR 396.11, both private 7 Regulatory Analysis for: Hours of Service of Assistance for Small Entities Drivers; Driver Rest and Sleep Operations, Final and for-hire, with the exception of Rule—Federal Motor Carrier Safety Administration. Pursuant to section 213 of SBREFA, operators of passenger-carrying CMVs. 68 FR 2245—Published April 23, 2003. FMCSA wants to assist small entities in This proposed rule is based on the 8 See the 2000 TTS blue Book of Trucking understanding this proposed rule so that authority of the Motor Carrier Act of Companies; number adjusted to 2008 dollars for they can better evaluate its effects on 1935 (1935 Act) [49 U.S.C. 31502(b)] inflation. 9 Motor Carrier Management Information system them and participate in the rulemaking and the Motor Carrier Safety Act of 1984 (MCMIS) as of September 2012. initiative. If the proposed rule would (1984 Act) [49 U.S.C. 31136(a)], both of 10 CMV Fact sheet March 2013. Available at affect your small business, organization, which are broadly discretionary. The http://www.fmcsa.dot.gov/documents/facts- or governmental jurisdiction and you rule implements, to some extent, the research/CMV-Facts.pdf. have questions concerning its Administrator’s authority under 11 U.S. Small Business Administration Table of small Business Size Standards matched to North provisions or options for compliance, § 31136(a)(1) to ensure that CMVs are American Industry Classification System (NAICS) maintained, equipped, loaded, and codes, effective January 1, 2012. See NAICS http://www.sba.gov/sites/default/files/files/ operated safely. The NPRM is also based subsector 484, Truck Transportation available at Size_Standards_Table.pdf.

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please consult the FMCSA point of environmental impact statement under System (L&I), FMSCA estimates that contact, Mike Huntley, listed in the FOR FMCSA Order 5610.1, paragraph 6(aa) there are approximately 4,117,000 FURTHER INFORMATION CONTACT section of of Appendix 2. The Categorical CMVs being operated that are subject to this proposed rule. Exclusion under paragraph 6(aa) relates these requirements, which includes Small businesses may send comments to regulations requiring motor carriers, 1,845,000 tractors and 101,000 on the actions of Federal employees drivers, and others to ‘‘inspect, repair, passenger-carrying CMVs, but excludes who enforce or otherwise determine and provide maintenance for every CMV the 152,000 CMVs of single-vehicle compliance with Federal regulations to used on a public road’’, which is the owner operators. Consistent with past the Small Business and Agriculture focus of this rulemaking. A Categorical analyses of this ICR, the Agency Regulatory Enforcement Ombudsman Exclusion determination is available for assumes that these CMVs are used on and the Regional Small Business inspection or copying in the average 65 percent of the days of a year, Regulatory Fairness Boards. The regulations.gov Web site listed under and that 25 percent of tractor-trailer Ombudsman evaluates these actions ADDRESSES. drivers operate two vehicle annually and rates each agency’s In addition to the NEPA requirements combinations per day, which effectively responsiveness to small business. If you to examine impacts on air quality, the increases the number of CMVs or CMV wish to comment on actions by Clean Air Act (CAA) as amended (42 combinations requiring a DVIR by employees of FMCSA, call 1–888–REG– U.S.C. 7401 et seq.) also requires 461,250 (25 percent × 1,845,000 tractors) FAIR (1–888–734–3247). FMCSA to analyze the potential impact to a total of 4,578,250 (4,117,000 CMVs of its actions on air quality and to Unfunded Mandates Reform Act of 1995 + 461,250 additional tractor-trailer ensure that FMCSA actions conform to combinations). Applying the 65 percent The Unfunded Mandates Reform Act State and local air quality utilization rate yields an annual of 1995 (2 U.S.C. 1531–1538) requires implementation plans. No additional estimate of 1,086,189,813 DVIRs Federal agencies to assess the effects of contributions to air emissions are (4,578,250 CMVs or CMV combinations their discretionary regulatory actions. In expected from this rule and FMCSA × 65 percent × 365 days per year). particular, the Act addresses actions expects the rule to not be subject to the FMCSA has parsed the DVIR process that may result in the expenditure by a Environmental Protection Agency’s into two steps. The first step, filling out State, local, or tribal government, in the General Conformity Rule (40 CFR parts a DVIR is estimated to take 2 minutes, aggregate, or by the private sector of 51 and 93). 30 seconds. The second step, reviewing $143.1 million (which is the value of FMCSA seeks comment on these and signing a DVIR is estimated to take $100 million in 2010 after adjusting for determinations. 20 seconds when defects are reported inflation) or more in any 1 year. and 5 seconds when no defects are Although this proposed rule would not Paperwork Reduction Act reported. When there are no defects to result in such expenditure, FMCSA The Paperwork Reduction Act of 1995 note, there is nothing to review on the discusses the effects of this rule (44 U.S.C. 3507(d)) requires FMCSA to DVIR, and the form requires only a elsewhere in this preamble. consider the impact of paperwork and other information collection burdens signature. The Agency estimates that 5 National Environmental Policy Act and imposed on the public. This proposed percent of DVIRs note defects, and that Clean Air Act rule would result in a reduction of 95 percent of DVIRs note no defects. FMCSA analyzed this NPRM for the burden hours for the ‘‘Inspection, If this proposed rule were to go into purpose of the National Environmental Repair, and Maintenance’’ information effect, 93 percent of the burden Policy Act of 1969 (NEPA) (42 U.S.C. collection request (ICR), OMB control associated with DVIRs would be 4321 et seq.) and determined under its number 2126–0003. This ICR comprises eliminated. The remaining burden environmental procedures Order 5610.1, six individual information collections, would be associated with DVIRs that published February 24, 2004 (69 FR each corresponding to a different area of note defects, and no-defect DVIRs for 9680), that this proposed action does the inspection, repair, and maintenance passenger-carrying CMVs. The annual not have any effect on the quality of the requirements. This proposed rule affects burden remaining from these two environment. Therefore, this NPRM is only the DVIR section of this ICR. activities would be 2,564,615 hours and categorically excluded from further Based on data from its Motor Carrier 980,123 hours respectively. The table analysis and documentation in an Management Information System below illustrates how these results were environmental assessment or (MCMIS) and Licensing and Insurance calculated.

TABLE 2—DETAIL OF DVIR PRA CALCULATIONS

Total DVIRs (CMVs × utili- Number of Utilization rate Percent of zation rate × Total annual Activity CMVs or CMV (of 365 cal- CMVs affected percent of Burden per DVIR hourly burden combinations endar days) CMVs affected × 365)

Defect DVIRs, All ...... 4,578,250 65 5 54,309,491 170 seconds ...... 2,564,615 No Defect DVIRS, passenger-car- 101,000 65 95 22,764,138 155 seconds...... 980,123 rying CMVs.

Total ...... 3,544,738

After this proposed rule becomes (4,578,250 CMVs × 65% utilization × hourly burden of no defect DVIRs for effective, defect DVIRs will create 365 days × 5% of CMVs × 170 seconds non-passenger carrying CMVs is 2,564,615 hours of annual burden ÷ 3,600 seconds per hour). The annual estimated to be 980,123 hours (101,000

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CMVs × 65% utilization × 365 days × compliance on States or localities. § 392.7 Equipment, inspection and use. 95% of CMVs × 155 seconds ÷ 3,600 FMCSA has analyzed this proposed rule (a) No commercial motor vehicle shall seconds per hour). The total remaining under that Order and has determined be driven unless the driver is satisfied hourly burden of DVIRs will be that it does not have implications for that the following parts and accessories 3,544,738 hours. This new total federalism. are in good working order, nor shall any represents a reduction of 46,669,294 Executive Order 12372 driver fail to use or make use of such hours compared to the 50,214,032 hours (Intergovernmental Review) parts and accessories when and as of annual burden estimated in the needed: currently approved ICR. The monetary The regulations implementing Service brakes, including trailer brake value of this annual burden reduction, Executive Order 12372 regarding connections. calculated using an hourly labor cost of intergovernmental consultation on Parking (hand) brake. $36, is $1.7 billion ((46,669,294 hours × Federal programs and activities do not Steering mechanism. $36 per hour) ÷ 1 billion). apply to this program. Lighting devices and reflectors. Executive Order 12630 (Taking of Executive Order 13211 (Energy Supply, Tires. Private Property) Distribution, or Use) Horn. This proposed rule would not effect a Windshield wiper or wipers. The FMCSA has analyzed this taking of private property or otherwise Rear-vision mirror or mirrors. have taking implications under proposed rule under Executive Order 13211, ‘‘Actions Concerning Regulations Coupling devices. Executive Order 12630, Governmental Wheels and rims. Actions and Interference with That Significantly Affect Energy Supply, Emergency equipment. Constitutionally Protected Property Distribution, or Use.’’ This proposal is Rights. not a significant energy action within * * * * * the meaning of section 4(b) of the Executive Order 12988 (Civil Justice Executive Order. This proposal is a PART 396—INSPECTION, REPAIR, Reform) procedural action, is not economically AND MAINTENANCE significant, and would not have a This proposed rule meets applicable ■ significant adverse effect on the supply, 3. The authority citation for part 396 standards in sections 3(a) and 3(b)(2) of is revised to read as follows: Executive Order 12988, Civil Justice distribution, or use of energy. Authority: 49 U.S.C. 31133, 31136, 31151, Reform, to minimize litigation, Privacy Impact Analysis eliminate ambiguity, and reduce and 31502; and 49 CFR 1.87. burden. FMCSA conducted a privacy impact ■ 4. Revise § 396.11(b)(2) to read as assessment of this rule as required by follows: Executive Order 13045 (Protection of section 522(a)(5) of the FY 2005 Children) § 396.11 Driver vehicle inspection Omnibus Appropriations Act, Public report(s). Executive Order 13045, ‘‘Protection of Law 108–447, 118 Stat. 3268 (Dec. 8, * * * * * Children from Environmental Health 2004) [set out as a note to 5 U.S.C. (b) * * * Risks and Safety Risks’’ (April 23, 1997, 552a]. The assessment considers any 62 FR 19885), requires that agencies impacts of the rule on the privacy of (2) Report content. (i) The report must issuing economically significant rules, information in an identifiable form and identify the vehicle and list any defect which also concern an environmental related matters. FMCSA has determined or deficiency discovered by or reported health or safety risk that an Agency has this rule would have no privacy to the driver which would affect the reason to believe may impacts. safety of operation of the vehicle or disproportionately affect children, must result in its mechanical breakdown. If a include an evaluation of the List of Subjects driver operates more than one vehicle environmental health and safety effects 49 CFR Part 392 during the day, a report must be of the regulation on children. Section 5 prepared for each vehicle operated. The of Executive Order 13045 directs an Alcohol abuse, Drug abuse, Highway driver of a passenger-carrying CMV Agency to submit for a covered safety, Motor carriers. subject to this regulation must prepare a report even if no defect or deficiency regulatory action an evaluation of its 49 CFR Part 396 environmental health or safety effects is discovered by or reported to the on children. The FMCSA has Highway safety, Motor carriers, Motor driver; the drivers of all other preliminarily determined that this vehicle safety, Reporting and commercial motor vehicles are not proposed rule is not a covered recordkeeping requirements. required to prepare a report if no defect regulatory action as defined under or deficiency is discovered by or For the reasons stated in the reported to the driver. Executive Order 13045. This preamble, FMCSA proposes to amend (ii) The driver must sign the report. determination is based on the fact that title 49 CFR, Code of Federal On two-driver operations, only one this proposal would not constitute an Regulations, chapter III, to read as driver needs to sign the driver vehicle environmental health risk or safety risk follows: that would disproportionately affect inspection report, provided both drivers children. PART 392—DRIVING OF COMMERCIAL agree as to the defects or deficiencies identified. Executive Order 13132 (Federalism) MOTOR VEHCILES * * * * * A rule has implications for federalism ■ 1. The authority citation for part 392 under Executive Order 13132, Dated: August 1, 2013. continues to read as follows: Federalism, if it has a substantial direct Anthony R. Foxx, effect on State or local governments and Authority: 49 U.S.C. 504, 13902, 31136, Secretary. would either preempt State law or 31151, 31502; and 49 CFR 1.87. [FR Doc. 2013–18981 Filed 8–6–13; 8:45 am] impose a substantial direct cost of ■ 2. Revise § 392.7(a) to read as follows: BILLING CODE 4910–EX–P

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DEPARTMENT OF COMMERCE ADDRESSES: You may submit comments, Background identified by the following document National Oceanic and Atmospheric number, NOAA–NMFS–2011–0073, by On June 4, 2013, we published a Administration any of the following methods: proposed rule in the Federal Register • Electronic Submissions: Submit all (78 FR 33300) in response to a petition 50 CFR Part 224 electronic public comments via the submitted by WildEarth Guardians RIN 0648–XZ50 Federal eRulemaking Portal. Go to requesting we list six sawfish species: www.regulations.gov/ knifetooth, narrow, or pointed sawfish Endangered and Threatened Wildlife #!docketDetail;D=NOAA-NMFS-2011- (A. cuspidata); dwarf or Queensland and Plants; 12-Month Finding and 0073, click the ‘‘Comment Now!’’ icon, sawfish (P. clavata; largetooth sawfish Proposed Endangered Listing of Five complete the required fields, and enter (P. pristis and P. microdon); green Species of Sawfish Under the or attach your comments. sawfish (P. zijsron); and the non-listed Endangered Species Act • Fax: (727)–824–5309; Attn: population(s) of smalltooth sawfish (P. Assistant Regional Administrator for AGENCY: pectinata) as endangered or threatened National Marine Fisheries Protected Resources. Service (NMFS), National Oceanic and under the ESA; or alternatively to list Instructions: You must submit any distinct population segments (DPS) Atmospheric Administration (NOAA), comments by one of the above methods Commerce. that exist under the ESA. We proposed to ensure that we receive, document, that the narrow sawfish (A. cuspidata); ACTION: Proposed rule, Extension of and consider them. Comments sent by public comment period. dwarf or Queensland sawfish (P. any other method, to any other address clavata); largetooth sawfish (P. pristis); or individual, or received after the end SUMMARY: We, NMFS, published a green sawfish (P. zijsron); and the non- of the comment period may not be proposed rule to list five sawfish listed population(s) of smalltooth species: the narrow sawfish (A. considered. All comments received are a part of the public record and will sawfish (P. pectinata) warrant listing as cuspidata); dwarf sawfish (P. clavata); endangered under the ESA, and we also largetooth sawfish (collectively P. generally be posted for public viewing on http://www.regulations.gov without proposed a change in the scientific pristis; formerly P. pristis, P. microdon, name for largetooth sawfish to codify and P. perotteti); green sawfish (P. change. All personal identifying the taxonomic reclassification of P. zijsron); and the non-listed information (e.g., name, address, etc.) perotteti to P. pristis. population(s) of smalltooth sawfish P. confidential business information, or pectinata as endangered under the ESA otherwise sensitive information We subsequently received a request to on 4 June 2013 (78 FR 33300). As part submitted voluntarily by the sender will extend the public comment period for of the proposal we provided a 60-day be publicly accessible. We will accept an additional 45 days. We have public comment period, scheduled to anonymous comments (enter ‘‘N/A’’ in determined that an extension of 45 days, end August 5, 2013. We received a the required fields if you wish to remain until September 19, 2013, will allow request to extend the public comment anonymous). Attachments to electronic adequate time for the public to period by 45 days. In response to this comments will be accepted in Microsoft thoroughly review and comment on the request, we are extending the public Word, Excel, or Adobe PDF file formats proposed rule while still providing the comment period for the proposed action only. agency with sufficient time to meet our You can obtain the petition, the until September 19, 2013. The proposed statutory deadlines. rule also includes a proposed change in proposed rule, and the list of references the scientific name for largetooth electronically on our NMFS Web site at Authority: 16 U.S.C. 1531 et seq. sawfish to codify the taxonomic http://sero.nmfs.noaa.gov/pr/pr.htm. Dated: August 1, 2013. reclassification of P. perotteti to P. FOR FURTHER INFORMATION CONTACT: Donna S. Wieting, pristis. Shelley Norton, NMFS, Southeast Director, Office of Protected Resources, DATES: Written comments and Regional Office, (727) 824–5312; or Dr. National Marine Fisheries Service. information regarding the proposed rule Dwayne Meadows, NMFS, Office of [FR Doc. 2013–19091 Filed 8–6–13; 8:45 am] Protected Resources, (301) 427–8403. must be received by September 19, BILLING CODE 3510–22–P 2013. SUPPLEMENTARY INFORMATION:

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Notices Federal Register Vol. 78, No. 152

Wednesday, August 7, 2013

This section of the FEDERAL REGISTER OMB Number: 0560–0155. (3) Enhance the quality, utility, and contains documents other than rules or Expiration Date of Approval: 01/31/ clarity of the information to be proposed rules that are applicable to the 2014. collected; and public. Notices of hearings and investigations, Type of Request: Extension with (4) Minimize the burden of the committee meetings, agency decisions and collection of information on those who rulings, delegations of authority, filing of revision. petitions and applications and agency Abstract: This information collected are to respond, including through the statements of organization and functions are under OMB Number 0560–0155 is use of appropriate automated, examples of documents appearing in this needed to effectively administer the electronic, mechanical, or other section. FSA guaranteed farm loan programs. technological collection techniques or The information is collected by the FSA other forms of information technology. loan official in consultation with All responses to this notice, including DEPARTMENT OF AGRICULTURE participating commercial lenders. The name and addresses when provided, basic objective of the guaranteed loan will be summarized and included in the Farm Service Agency program is to provide credit to request for OMB approval. All applicants who are unable to obtain comments will also become a matter of Information Collection; Guaranteed public record. Farm Loan Program credit from lending institutions without a guarantee. The reporting requirements Signed on July 26, 2013. AGENCY: Farm Service Agency, USDA. imposed on the public by the Juan M. Garcia, ACTION: Notice; request for comment. regulations at 7 CFR part 762 are Administrator, Farm Service Agency. necessary to administer the guaranteed SUMMARY: In accordance with the [FR Doc. 2013–19015 Filed 8–6–13; 8:45 am] loan program in accordance with BILLING CODE 3410–05–P Paperwork Reduction Act of 1995, the statutory requirements of the Farm Service Agency (FSA) is seeking Consolidated Farm and Rural comments from all interested Development Act and are consistent DEPARTMENT OF AGRICULTURE individuals and organizations on the with commonly performed lending extension and revision of a currently practices. Collection of information after Food and Nutrition Service approved information collection loans are made is necessary to protect associated with the Guaranteed Farm the Government’s financial interest. The Agency Information Collection Loan Program. This information revision to the information reflects that Activities: Proposed Collection; collection is used to make and service the burden hours have decreased due to Comment Request—Enhancing loans guaranteed by FSA to eligible less usage of interest assistance farmers and ranchers. Completion Rates for Supplemental agreement form because FSA does not Nutrition Assistance Program (SNAP) DATES: We will consider comments that have funding for the interest assistance we receive by October 7, 2013. Quality Control Reviews; Correction program. AGENCY: Food and Nutrition Service ADDRESSES: We invite you to submit Estimate of Average Time to respond: (FNS), USDA. comments on this notice. In your 62.2 minutes per response. The average ACTION: Notice; correction. comments, include date, volume, and travel time, which is included in the page number of this issue of the Federal total annual burden, is estimated to be SUMMARY: The Food and Nutrition Register. You may submit comments by 1 hour per respondent. Service is correcting this notice, which any of the following methods: • Type of Respondents: Farmers and invites the general public and other Federal eRulemaking Portal: Go to: ranchers. public agencies to comment on this www.regulations.gov. Follow the online Estimated Number of Respondents: proposed information collection. This instructions for submitting comments. 16,100. notice was published in the Federal • Mail: Trent Rogers, Senior Loan Register on July 26, 2013. This notice Specialist, USDA, FSA, Stop 0522, 1400 Estimated Number of Report Filed per corrects where and to whom the Independence Avenue SW., Respondent: 15.1. comments are to be sent. Washington, DC 20250. Estimated Total Annual Number of You may also send comments to the Responses: 243,834. DATES: Written comments must be Desk Officer for Agriculture, Office of Estimated Total Annual Burden received on or before September 24, Information and Regulatory Affairs, Hours: 252,939. 2013. Office of Management and Budget, We are requesting comments on all ADDRESSES: Comments should be sent to Washington, DC 20503. Copies of the aspects of this information collection to Richard Lucas, Office of Policy Support, information collection may be requested help us to: Food and Nutrition Service, U.S. by contacting Trent Rogers at the above (1) Evaluate whether the collection of Department of Agriculture, 3101 Park addresses. information is necessary for the proper Center Drive, Room 1014, Alexandria, FOR FURTHER INFORMATION CONTACT: performance of the functions of FSA, VA 22302. Comments may also be Trent Rogers, Senior Loan Specialist, including whether the information will submitted via fax to the attention of (202) 720–3889. have practical utility; Richard Lucas at 703–305–2576 or via SUPPLEMENTARY INFORMATION: (2) Evaluate the accuracy of FSA’s email to [email protected]. estimate of burden including the Comments will also be accepted through Description of Information Collection validity of the methodology and the Federal eRulemaking Portal. Go to Title: Guaranteed Farm Loans. assumptions used; http://www.regulations.gov, and follow

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the online instructions for submitting FOR FURTHER INFORMATION CONTACT: Members of the public are entitled to comments electronically. Susan Johnson, West Zone Recreation submit written comments. The All written comments will be open for Program Manager, Prescott National comments must be received in the public inspection at the office of the Forest, 928–443–8075. regional office by Friday, October 11, Food and Nutrition Service during SUPPLEMENTARY INFORMATION: The 2013. Comments may be mailed to the regular business hours (8:30 a.m. to 5:00 Federal Recreation Lands Enhancement Rocky Mountain Regional Office, U.S. p.m. Monday through Friday) at 3101 Act (Title VII, Pub. L. 108–447) directed Commission on Civil Rights, 999 18th Park Center Drive, Room 1014, the Secretary of Agriculture to publish Street, Suite 1380 South, Denver, CO Alexandria, VA 22302. a six month advance notice in the 80202, faxed to (303) 866–1050, or FOR FURTHER INFORMATION CONTACT: Federal Register whenever new emailed to [email protected]. Persons Requests for additional information or recreation fee areas are established. who desire additional information may copies of this information collection This new fee will be reviewed by the contact the Rocky Mountain Regional should be directed to Richard Lucas at Bureau of Land Management Arizona Office at 303–866–1040. 703–305–2017. Recreation Resource Advisory Council Persons needing accessibility services (RRAC) prior to final decision and should contact the Rocky Mountain SUPPLEMENTARY INFORMATION: This implementation by the Regional Regional Office at least 10 working days notice corrects the contact person Forester, Southwestern Region, USDA before the scheduled date of the published in this proposed information Forest Service. meeting. collection in the Federal Register The Prescott National Forest currently Records generated from this meeting (Volume 78, FR 45173, July 26, 2013). has three other group campground may be inspected and reproduced at the Dated: August 2, 2013. facilities. These group campgrounds are Rocky Mountain Regional Office, as Audrey Rowe, reserved regularly throughout the they become available, both before and Administrator, Food and Nutrition Service. recreation season. The public has after the meeting. Persons interested in [FR Doc. 2013–19064 Filed 8–6–13; 8:45 am] indicated a desire for additional the work of this advisory committee are BILLING CODE 3410–30–P developed group camping opportunities advised to go to the Commission’s Web on the Prescott National Forest. site, www.usccr.gov, or to contact the A market comparison indicates that Rocky Mountain Regional Office at the DEPARTMENT OF AGRICULTURE the $50–$125 overnight fee is both above phone number, email or street reasonable and acceptable for this type address. Forest Service of recreation opportunity. The meeting will be conducted Forest visitors can reserve Osprey or pursuant to the provisions of the rules Notice of New Recreation Fee Peregrine Sites at Eagle Ridge Group and regulations of the Commission and FACA. AGENCY: Prescott National Forest, Campground by contacting the National Southwestern Region, USDA Forest Recreation Reservation Service, at Dated in Chicago, IL, on August 2, 2013. Service. www.recreation.gov or by calling 1–877– David Mussatt, 444–6777. The National Recreation ACTION: Notice of New Recreation Fee. Acting Chief, Regional Programs Reservation Service charges a $9 fee for Coordination Unit. internet reservations and $10 fee for SUMMARY: The Prescott National Forest [FR Doc. 2013–19045 Filed 8–6–13; 8:45 am] phone reservations. is proposing to charge a fee at the new BILLING CODE 6335–01–P Eagle Ridge Group Campground near Dated: July 31, 2013. Prescott, Arizona, constructed in 2011. Tom Torres, Eagle Ridge Group Campground has two Acting Prescott National Forest Supervisor. COMMISSION ON CIVIL RIGHTS sites with the following proposed fees: [FR Doc. 2013–19047 Filed 8–6–13; 8:45 am] Sunshine Act Notice (1) Osprey recreation fee is proposed at BILLING CODE 3410–11–P $75/night for up to 50 persons or $125/ AGENCY: United States Commission on night for up to 75 persons; (2) Peregrine Civil Rights. recreation fee is proposed at $50/night COMMISSION ON CIVIL RIGHTS for 1–25 persons. Rental of other ACTION: Notice of Business Meeting. facilities on the Prescott National Forest Agenda and Notice of Public Meeting DATE AND TIME: Friday, August 16, 2013; and other Arizona National Forests has of the South Dakota Advisory 9:30 a.m. EST. shown that publics appreciate and enjoy Committee PLACE: 1331 Pennsylvania Ave NW., the availability of group rental facilities. Suite 1150, Washington, DC 20425. Notice is hereby given, pursuant to Funds from the fee revenue will be used Meeting Agenda for the continued operation and the provisions of the rules and maintenance of Eagle Ridge Group regulations of the U.S. Commission on I. Approval of Agenda Campground. Civil Rights (Commission), and the II. Program Planning Federal Advisory Committee Act • Vote to Approve and Adopt the DATES: Send any comments about these (FACA), that a planning meeting of the Final Draft of the ‘‘Civil Rights fee proposals by October 18, 2013 so South Dakota Advisory Committee to Implications of Eminent Domain comments can be compiled, analyzed the Commission will convene at 1:00 Abuse’’ report and shared with the Bureau of Land p.m. (CDT) and adjourn at 3:00 p.m., on • Vote to Approve and Adopt the Management Arizona Recreation Wednesday, September 11, 2013, at the Final Draft of the ‘‘Assessing the Resource Advisory Council (R–RAC). Minnehaha County Courthouse, 425 Impact of Criminal Background New fees are proposed to begin in April North Dakota Avenue, 5th Floor, Checks and the Equal Employment 2014. Multipurpose Room, Sioux Falls, SD Opportunity Commission’s ADDRESSES: Forest Supervisor, Prescott 57104. The purpose of the meeting is for Conviction Records Policy’’ report. National Forest, 344 S. Cortez St, orientation and ethics training and • Discussion & Vote on 2014 USCCR Prescott, Arizona, 86303. project planning. Business Meeting Calendar

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• Discussion & Action on 2014 Title: Survey of Charter Boat and DC 20230 (or via the Internet at Statutory Enforcement Report topic Head Boat Angler Interactions with Sea [email protected]). • Discussion on Submission of Turtles. Written comments and Statements & Rebuttals for OMB Control Number: None. recommendations for the proposed Form Number(s): NA. Commission Reports information collection should be sent Type of Request: Regular submission III. Management and Operations within 30 days of publication of this • (request for a new information Staff Director’s report notice to collection). IV. Approval of State Advisory [email protected]. Committee Appointment Slates Number of Respondents: 4,000. • Maine Average Hours Per Response: Request Dated: August 1, 2013. • Mississippi to participate in survey, 30 seconds; Gwellnar Banks, • Rhode Island survey, 10 minutes. Management Analyst, Office of the Chief • Tennessee Burden Hours: 365. Information Officer. • Needs and Uses: This request is for a Washington [FR Doc. 2013–18977 Filed 8–6–13; 8:45 am] • new information collection. West Virginia BILLING CODE 3510–22–P V. Adjourn Meeting The collection of recreational fishing CONTACT PERSON FOR FURTHER bycatch data is necessary to fulfill statutory requirements of Section 303 of INFORMATION: Lenore Ostrowsky, Acting DEPARTMENT OF COMMERCE Chief, Public Affairs Unit (202) 376– the Magnuson-Stevens Fishery 8591. Conservation and Management Act (16 Economic Development Administration U.S.C. 1852 et. seq.), Section 401 of the Hearing-impaired persons who will attend Magnuson-Stevens Fishery Notice of Petitions by Firms for the meeting and require the services of a sign Conservation and Management language interpreter should contact Pamela Determination of Eligibility To Apply Dunston at (202) 376–8105 or at Reauthorization Act, and to comply for Trade Adjustment Assistance [email protected] at least seven with Executive Order 12962 on business days before the scheduled date of Recreational Fisheries. Additionally, the AGENCY: Economic Development the meeting. Endangered Species Act of 1973 (ESA; Administration, Department of 16 U.S.C. 1531 et seq.) imposed Commerce. Dated: August 5, 2013. prohibitions against the taking of ACTION: David Mussatt, endangered species. This collection will Notice and Opportunity for Public Comment. Acting RPCU Chief. seek to better understand the nature and [FR Doc. 2013–19235 Filed 8–5–13; 4:15 pm] overall level of sea turtle interactions Pursuant to Section 251 of the Trade BILLING CODE 6335–01–P with recreational anglers on charter boats and headboats. The information Act 1974, as amended (19 U.S.C. 2341 collected will be used to develop more et seq.), the Economic Development Administration (EDA) has received DEPARTMENT OF COMMERCE reliable bycatch estimates. Affected Public: Individuals or petitions for certification of eligibility to Submission for OMB Review; households. apply for Trade Adjustment Assistance Comment Request Frequency: One time. from the firms listed below. Respondent’s Obligation: Voluntary. Accordingly, EDA has initiated The Department of Commerce will OMB Desk Officer: investigations to determine whether submit to the Office of Management and [email protected]. increased imports into the United States Budget (OMB) for clearance the Copies of the above information of articles like or directly competitive following proposal for collection of collection proposal can be obtained by with those produced by each of these information under the provisions of the calling or writing Jennifer Jessup, firms contributed importantly to the Paperwork Reduction Act (44 U.S.C. Departmental Paperwork Clearance total or partial separation of the firm’s Chapter 35). Officer, (202) 482–0336, Department of workers, or threat thereof, and to a Agency: National Oceanic and Commerce, Room 6616, 14th and decrease in sales or production of each Atmospheric Administration (NOAA). Constitution Avenue NW, Washington, petitioning firm.

LIST OF PETITIONS RECEIVED BY EDA FOR CERTIFICATION ELIGIBILITY TO APPLY FOR TRADE ADJUSTMENT ASSISTANCE [7/19/2013 through 8/01/2013]

Date accepted Firm name Firm address for investigation Product(s)

Paragon Decors, Inc ...... 195 Paragon Drive, 7/19/2013 The firm manufactures framed wall decor including mirrors, Albertville, AL 35950. prints, paintings, metal wall decor, and lamps. Questech Corporation ...... 92 Park Street, Rutland, VT 7/24/2013 The firm manufactures decorative tile and trim products 5701. from metal and stone that include electrical switch plates, kitchen and bathroom accessories. ICON Health & Fitness, Inc ... 1500 S 1000 W, Logan, UT 7/31/2013 The firm is a manufacturer of fitness and exercise equip- 84321. ment. E.T. Precision Optics, Inc ...... 33 Curlew Street, Rochester, 7/31/2013 The firm manufacturers rotational and prismatic components NY 14606. used in optics, medical, defense, electrical, microwave and aerospace industries.

Any party having a substantial request a public hearing on the matter. submitted to the Trade Adjustment interest in these proceedings may A written request for a hearing must be Assistance for Firms Division, Room

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71030, Economic Development discouraging its citizens from and 112 Avenue Kleber, 75116 Paris, Administration, U.S. Department of participating in foreign restrictive trade France; Commerce, Washington, DC 20230, no practices and boycotts directed against Gatewick LLC, a/k/a Gatewick Freight & later than ten (10) calendar days friendly countries. Cargo Services, a/k/a/Gatewick Aviation Services, G#22 Dubai Airport Free Zone, following publication of this notice. II. Method of Collection P.O. Box 393754, Dubai, United Arab Please follow the requirements set Emirates; and P.O. Box 52404, Dubai, forth in EDA’s regulations at 13 CFR Submitted on paper or electronically United Arab Emirates; and Mohamed 315.9 for procedures to request a public III. Data Abdulla Alqaz Building, Al Maktoum hearing. The Catalog of Federal Street, Al Rigga, Dubai, United Arab Domestic Assistance official number OMB Control Number: 0694–0012. Emirates; and title for the program under which Form Number(s): BIS–621P, BIS– Pejman Mahmood Kosarayanifard, a/k/a these petitions are submitted is 11.313, 6051P, BIS–6051 P–a. Kosarian Fard, P.O. Box 52404, Dubai, Type of Review: Regular submission United Arab Emirates; Trade Adjustment Assistance for Firms. (extension of a currently approved Mahmoud Amini, G#22 Dubai Airport Free Dated: August 1, 2013. information collection). Zone, P.O. Box 393754, Dubai, United Arab Michael DeVillo, Affected Public: Business or other for- Emirates; and P.O. Box 52404, Dubai, United Arab Emirates; and Mohamed Eligibility Examiner. profit organizations. Abdulla Alqaz Building, Al Maktoum [FR Doc. 2013–19033 Filed 8–6–13; 8:45 am] Estimated Number of Respondents: 892. Street, Al Rigga, Dubai, United Arab BILLING CODE 3510–WH–P Emirates; Estimated Time per Response: 1 hour Kerman Aviation, a/k/a GIE Kerman to 1 hour and 30 minutes. Aviation, 42 Avenue Montaigne 75008, DEPARTMENT OF COMMERCE Estimated Total Annual Burden Paris, France; Hours: 1171. Sirjanco Trading LLC, P.O. Box 8709, Dubai, Bureau of Industry and Security Estimated Total Annual Cost to United Arab Emirates; Public: $0. Ali Eslamian, 4th Floor, 33 Cavendish Proposed Information Collection; Square, London, W1G0PW, United Comment Request; Report of Requests IV. Request for Comments Kingdom; and 2 Bentinck Close, Prince for Restrictive Trade Practice or Comments are invited on: (a) Whether Albert Road, St. Johns Wood, London Boycott the proposed collection of information NW87RY, United Kingdom; is necessary for the proper performance Mahan Air General Trading LLC, 19th Floor AGENCY: Bureau of Industry and of the functions of the agency, including Al Moosa Tower One, Sheik Zayed Road, Security, Commerce. Dubai 40594, United Arab Emirates; whether the information shall have Skyco (UK) Ltd., 4th Floor, 33 Cavendish ACTION: Notice. practical utility; (b) the accuracy of the Square, London, W1G 0PV, United agency’s estimate of the burden SUMMARY: Kingdom; The Department of (including hours and cost) of the Commerce, as part of its continuing Equipco (UK) Ltd., 2 Bentinck Close, Prince proposed collection of information; (c) Albert Road, London, NW8 7RY, United effort to reduce paperwork and ways to enhance the quality, utility, and Kingdom; respondent burden, invites the general clarity of the information to be Mehdi Bahrami, Mahan Airways–Istanbul public and other Federal agencies to collected; and (d) ways to minimize the Office, Cumhuriye Cad. Sibil Apt No: 101 take this opportunity to comment on burden of the collection of information D:6, 34374 Emadad, Sisli Istanbul, Turkey. proposed and/or continuing information on respondents, including through the collections, as required by the Order Renewing Order Temporarily use of automated collection techniques Denying Export Privileges Paperwork Reduction Act of 1995. or other forms of information DATES: Written comments must be Pursuant to Section 766.24 of the technology. Export Administration Regulations, 15 submitted on or before October 7, 2013. Comments submitted in response to CFR parts 730–774 (2013 (‘‘EAR’’ or the ADDRESSES: Direct all written comments this notice will be summarized and/or ‘‘Regulations’’), I hereby grant the to Jennifer Jessup, Departmental included in the request for OMB request of the Office of Export Paperwork Clearance Officer, approval of this information collection; Enforcement (‘‘OEE’’) to renew the Department of Commerce, Room 6616, they also will become a matter of public February 4, 2013 Order Temporarily 14th and Constitution Avenue NW., record. Denying the Export Privileges of Mahan Washington, DC 20230 (or via the Dated: August 2, 2013. Internet at [email protected]). Airways, Zarand Aviation, Gatewick Gwellnar Banks, LLC, Pejman Mahmood Kosarayanifard, FOR FURTHER INFORMATION CONTACT: Management Analyst, Office of the Chief Mahmoud Amini, Kerman Aviation, Requests for additional information or Information Officer. Sirjanco Trading LLC, Ali Eslamian, copies of the information collection [FR Doc. 2013–19007 Filed 8–6–13; 8:45 am] Mahan Air General Trading LLC, Skyco instrument and instructions should be BILLING CODE 3510–33–P (UK) Ltd., Equipco (UK Ltd., and Mehdi directed to Larry Hall, BIS ICB Liaison, Bahrami. I find that renewal of the (202) 482–4895, Temporary Denial Order (‘‘TDO’’ is [email protected]. DEPARTMENT OF COMMERCE necessary in the public interest to SUPPLEMENTARY INFORMATION: prevent an imminent violation of the Bureau of Industry and Security EAR. I. Abstract This information is used to monitor Notice I. Procedural History requests for participation in foreign In the matter of: On March 17, 2008, Darryl W. boycotts against countries friendly to Mahan Airways, Mahan Tower, No. 21, Jackson, the then-Assistant Secretary of the U.S. The information is analyzed to Azadegan St., M.A. Jenah Exp. Way, Commerce for Export Enforcement note changing trends and to decide Tehran, Iran; (‘‘Assistant Secretary’’), signed a TDO upon appropriate action to be taken to Zarand Aviation, a/k/a GIE Zarand Aviation, denying Mahan Airways’ export carry out the United States’ policy of 42 Avenue Montaigne, 75008 Paris, France; privileges for a period of 180 days on

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the grounds that its issuance was Sections 766.5 and 766.24(d) of the Boeing 747s (‘‘Aircraft 1–3’’), items necessary in the public interest to Regulations. No opposition to any subject to the EAR and classified under prevent an imminent violation of the aspect of the renewal of the TDO has Export Control Classification Number Regulations. The TDO also named as been received from either Mahan (‘‘ECCN’’) 9A991.b, without the required denied persons Blue Airways, of Airways or Zarand Aviation. U.S. Government authorization. Further Yerevan, Armenia (‘‘Blue Airways of Furthermore, no appeal of the related evidence submitted by BIS indicated Armenia’’), as well as the ‘‘Balli Group person determinations I made as part of that Mahan Airways was involved in the Respondents,’’ namely, Balli Group the September 3, 2010, February 25, attempted re-export of three additional PLC, Balli Aviation, Balli Holdings, 2011, August 24, 2011, April 9, 2012, U.S.-origin Boeing 747s (‘‘Aircraft 4–6’’) Vahid Alaghband, Hassan Alaghband, and February 4, 2013 renewal or to Iran. Blue Sky One Ltd., Blue Sky Two Ltd., modification orders has been made by As discussed in the September 17, Blue Sky Three Ltd., Blue Sky Four Ltd., Gatewick LLC, Kosarian Fard, 2008 renewal order, evidence presented Blue Sky Five Ltd., and Blue Sky Six Mahmoud Amini, Kerman Aviation, by BIS indicated that Aircraft 1–3 Ltd., all of the United Kingdom. The Sirjanco Trading LLC, Ali Eslamian, continued to be flown on Mahan TDO was issued ex parte pursuant to Mahan Air General Trading LLC, Skyco Airways’ routes after issuance of the Section 766.24(a), and went into effect (UK) Ltd., Equipco (UK) Ltd., or Mehdi TDO, in violation of the Regulations and on March 21, 2008, the date it was Bahrami.2 the TDO itself.3 It also showed that published in the Federal Register. Aircraft 1–3 had been flown in further The TDO subsequently has been II. Renewal of the TDO violation of the Regulations and the renewed in accordance with Section A. Legal Standard TDO on the routes of Iran Air, an 766.24(d), including most recently on Iranian Government airline. Moreover, Pursuant to Section 766.24, BIS may February 4, 2013.1 As of March 9, 2010, as discussed in the March 16, 2009, issue or renew an order temporarily the Balli Group Respondents and Blue September 11, 2009 and March 9, 2010 denying a respondent’s export privileges Airways were no longer subject to the Renewal Orders, Mahan Airways TDO. As part of the February 25, 2011 upon a showing that the order is registered Aircraft 1–3 in Iran, obtained TDO renewal, Gatwick LLC, Mahmoud necessary in the public interest to Iranian tail numbers for them (including Amini, and Pejman Mahmood prevent an ‘‘imminent violation’’ of the EP–MNA and EP–MNB), and continued Kosarayanifard (‘‘Kosarian Fard’’) were Regulations. 15 CFR 766.24(b)(1) and to operate at least two of them in added as related persons in accordance 776.24(d). ‘‘A violation may be violation of the Regulations and the with Section 766.23 of the Regulations. ‘imminent’ either in time or degree of TDO,4 while also committing an On July 1, 2011, the TDO was modified likelihood.’’ 15 CFR 766.24(b)(3). BIS additional knowing and willful by adding Zarand Aviation as a may show ‘‘either that a violation is violation of the Regulations and the respondent in order to prevent an about to occur, or that the general TDO when it negotiated for and imminent violation. Specifically, circumstances of the matter under acquired an additional U.S.-origin Zarand Aviation owned an Airbus A310 investigation or case under criminal or aircraft. The additional acquired aircraft subject to the Regulations that was being administrative charges demonstrate a was an MD–82 aircraft, which operated for the benefit of Mahan likelihood of future violations.’’ Id. As subsequently was painted in Mahan Airways in violation of both the TDO to the likelihood of future violations, Airways’ livery and flown on multiple and the Regulations. As part of the BIS may show that the violation under Mahan Airways’ routes under tail August 24, 2011 renewal, Kerman investigation or charge ‘‘is significant, number TC–TUA. Aviation, Sirjanco Trading LLC, and Ali deliberate, covert and/or likely to occur The March 9, 2010 Renewal Order Eslamian were added to the TDO as again, rather than technical or negligent also noted that a court in the United related persons. Mahan Air General [.]’’ Id. A ‘‘lack of information Kingdom (‘‘U.K.’’) had found Mahan Trading LLC, Skyco (UK) Ltd., and establishing the precise time a violation Airways in contempt of court on Equipco (UK) Ltd. were added as related may occur does not preclude a finding February 1, 2010, for failing to comply persons on April 9, 2012. Mehdi that a violation is imminent, so long as with that court’s December 21, 2009 and Bahrami was added to the TDO as a there is sufficient reason to believe the January 12, 2010 orders compelling related person as part of the February 4, likelihood of a violation.’’ Id. Mahan Airways to remove the Boeing 2013 renewal order. B. The TDO and BIS’s Request for 747s from Iran and ground them in the On July 9, 2013, BIS, through its Renewal Netherlands. Mahan Airways and the Office of Export Enforcement (‘‘OEE’’), Balli Group Respondents had been submitted a written request for renewal OEE’s request for renewal is based litigating before the U.K. court of the TDO. The current TDO dated upon the facts underlying the issuance concerning ownership and control of February 4, 2013, will expire on August of the initial TDO and the TDO renewals Aircraft 1–3. In a letter to the U.K. court 3, 2013, unless renewed on or before in this matter and the evidence dated January 12, 2010, Mahan Airways’ that date. Notice of the renewal request developed over the course of this Chairman indicated, inter alia, that was provided to Mahan Airways and investigation indicating a blatant Mahan Airways opposes U.S. Zarand Aviation by delivery of a copy disregard of U.S. export controls and the Government actions against Iran, that it of the request in accordance with TDO. The initial TDO was issued as a continued to operate the aircraft on its result of evidence that showed that routes in and out of Tehran (and had 1 The February 4, 2013 Order was published in Mahan Airways and other parties 158,000 ‘‘forward bookings’’ for these the Federal Register on February 8, 2013. 78 FR engaged in conduct prohibited by the aircraft), and that it wished to continue 9359 (Feb. 8, 2013). The TDO previously had been EAR by knowingly re-exporting to Iran renewed on September 17, 2008, March 16, 2009, September 11, 2009, March 9, 2010, September 3, three U.S.-origin aircraft, specifically 3 Engaging in conduct prohibited by a denial 2010, February 25, 2011, August 24, 2011, February order violates the Regulations. 15 CFR 764.2(a) and 15, 2012, and August 9, 2012. The August 24, 2011 2 A party named or added as a related person may (k). renewal followed the modification of the TDO on not oppose the issuance or renewal of the 4 The third Boeing 747 appeared to have July 1, 2011, which added Zarand Aviation as a underlying temporary denial order, but may file an undergone significant service maintenance and may respondent. Each renewal or modification order appeal of the related person determination in not have been operational at the time of the March was published in the Federal Register. accordance with Section 766.23(c). 9, 2010 renewal order.

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to do so and would pay damages if Government from Iran’s Islamic (tail numbers F–OJHH, F–OJHI, and EP– required by that court, rather than Revolutionary Guard Corps. Open VIP) were designated as SDGTs.9 ground the aircraft. source information shows this aircraft The February 4, 2013 Order laid out The September 3, 2010 renewal order remains in active operation in Mahan further evidence of continued and discussed the fact that Mahan Airways’ Airways’ fleet and has been flown from additional efforts by Mahan Airways violations of the TDO extended beyond Iran to Syria as recently as June 30, and other persons acting in concert with operating U.S.-origin aircraft in 2013. Mahan, including two Turkish violation of the TDO and attempting to In addition, as first detailed in the companies, to procure U.S.-origin acquire additional U.S.-origin aircraft. July 1, 2011 and August 24, 2011 orders, engines (MSNs 517621 and 517738) and In February 2009, while subject to the and discussed in the subsequent other aircraft parts in violation of the 10 TDO, Mahan Airways participated in renewal orders in this matter, Mahan TDO and the Regulations. The the export of computer motherboards, Airways also has continued to evade February 4, 2013 renewal order also items subject to the Regulations and U.S. export control laws by operating added Mehdi Bahrami as a related designated as EAR99, from the United two Airbus A310 aircraft, bearing person in accordance with Section States to Iran, via the United Arab Mahan Airways’ livery, colors and logo, 766.23 of the Regulations. Bahrami, a Emirates (‘‘UAE’’), in violation of both on flights into and out of Iran.6 The Mahan Vice-President and the head of the TDO and the Regulations, by aircraft are owned, respectively, by Mahan’s Istanbul Office, also was transporting and/or forwarding the Zarand Aviation and Kerman Aviation, involved in Mahan’s acquisition of the computer motherboards from the UAE both of whose corporate registrations original three Boeing 747s (Aircraft 1–3) to Iran. Mahan Airways’ violations were list Mahan Air General Trading as a that resulted in the original TDO, and facilitated by Gatewick LLC, which not member of their Groupement D’interet has had a business relationship with only participated in the transaction, but Economique (‘‘Economic Interest Mahan dating back to 1997. OEE’s current renewal request also has stated to BIS that it acts as Group’’).7 Mahan Airways’ sole booking agent for includes evidence obtained after the cargo and freight forwarding services in At the time of the July 1, 2011 and February 4, 2013 renewal order showing the UAE. August 24, 2011 Orders, these Airbus further attempts by Mahan to evade the Moreover, in a January 24, 2011 filing A310s were registered in France, with TDO. Specifically, evidence obtained by in the U.K. court, Mahan Airways tail numbers F–OJHH and F–OJHI, OEE, reveals that in or about June 2012, asserted that Aircraft 1–3 were not being respectively. OEE subsequently Mahan Airways was involved in efforts used, but stated in pertinent part that presented evidence that after the August to obtain a U.S.-origin GE CF6–50C2 the aircraft were being maintained in 24, 2011 renewal, Mahan Airways and aircraft engine (MSN 528350) from the Iran especially ‘‘in an airworthy Zarand Aviation worked in concert, United States via Turkey. Multiple condition’’ and that, depending on the along with Kerman Aviation, to de- Mahan Airways’ employees, including outcome of its U.K. court appeal, the register the two Airbus A310 aircraft in Mehdi Bahrami, were involved in or aircraft ‘‘could immediately go back into France and to register both aircraft in aware of matters related to the engine’s service . . . on international routes into Iran (with, respectively, Iranian tail arrival in Turkey from the United States, and out of Iran.’’ Mahan Airways’ numbers EP–MHH and EP–MHI). It was plans to visually inspect the engine, and January 24, 2011 submission to U.K. determined subsequent to the February prepare it for shipment from Turkey. A Court of Appeal, at p. 25, ¶¶ 108, 110. 15, 2012 renewal order that the Turkish national who is currently a This clearly stated intent, both on its registration switch for these A310s was director/operator of a Turkish aircraft own and in conjunction with Mahan cancelled; however, both aircraft parts supplier and previously has Airways’ prior misconduct and continued to actively fly for Mahan conducted Mahan related business with statements, demonstrated the need to Airways under the original French tail Mehdi Bahrami and Ali Eslamian was renew the TDO in order to prevent numbers. also involved. imminent future violations. Two of In addition to Mahan Airways’ OEE also has obtained a sworn these three 747s subsequently were continued unlawful operation of these affidavit regarding the ownership of this removed from Iran and are no longer in two A310s, as well as the remaining 747 Turkish aircraft parts supplier. The Mahan Airway’s possession. The third (MSN 23480 and Iranian tail number affidavit by the Managing Director of of these 747s, with Manufacturer’s EP–MNE) discussed above, the August Mahan Airways’ General Sales Agent in Serial Number (‘‘MSN’’) 23480 and 2012 renewal order found that Mahan Thailand stated that the shares of this Iranian tail number EP–MNE, remains Airways had acquired another Airbus in Iran under Mahan’s control. Pursuant A310 aircraft subject to the 9 See http://www.treasury.gov/resource-center/ 8 sanctions/OFAC-Enforcement/pages/ to Executive Order 13324, it was Regulations, with MSN 499 and Iranian 20120919.aspx. Mahan Airways was previously designated a Specially Designated tail number EP–VIP, in violation of the designated by OFAC as a SDGT on October 18, Global Terrorist (‘‘SDGT’’) by the U.S. TDO and the Regulations. On September 2011. 77 FR 64,427 (October 18, 2011). Department of the Treasury’s Office of 19, 2012, all three Airbus A310 aircraft 10 As previously discussed in the February 4, 2013 Order, Turkish Company No. 1 purchased a Foreign Assets Control (‘‘OFAC’’) on CF6–50C2 aircraft engine (MSN517621) from the September 19, 2012.5 Furthermore, as 6 The Airbus A310s are powered with U.S.-origin United States in July 2012, on behalf of Mahan discussed in the February 4, 2013 Order, engines. The engines are subject to the EAR and Airways. OEE was able to prevent this engine from open source information indicated that classified under Export Control Classification reaching Mahan by issuing a redelivery order to the (‘‘ECCN’’) 9A991.d. The Airbus A310s contain freight forwarder in accordance with Section 758.8 this 747, which is painted in the livery controlled U.S.-origin items valued at more than 10 of the Regulations. OEE also issued Turkish and logo of Mahan Airways, has been percent of the total value of the aircraft and as a Company No. 1 a redelivery order for the second flown between Iran and Syria, and is result are subject to the EAR. They are classified CF6–50C2 engine (MSN 517738) on July 30, 2012. suspected of ferrying weapons and/or under ECCN 9A991.b. The reexport of these aircraft The owner of the second engine subsequently to Iran requires U.S. Government authorization cancelled the item’s sale to Turkish Company No. other equipment to the Syrian pursuant to Section 746.7 of the Regulations. 1. In September 2012, OEE was alerted by a U.S. 7 Kerman Aviation’s corporate registration also exporter that another Turkish company (‘‘Turkish 5 See http://www.treasury.gov/resource-center/ lists Mahan Aviation Services Company as an Company No. 2’’) was attempting to purchase sanctions/OFAC-Enforcement/pages/ additional member of its Economic Interest Group. aircraft spare parts intended for re-export by 20120919.aspx. 8 See note 6, supra. Turkish Company No. 2 to Mahan Airways.

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Turkish aircraft parts supplier for which Building, Al Maktoum Street, Al Rigga, attempts to acquire such ownership, he is the listed owner are ‘‘actually the Dubai, United Arab Emirates; KERMAN possession or control; property of and owned by Mahan.’’ He AVIATION A/K/A GIE KERMAN C. Take any action to acquire from or further stated that he held ‘‘legal title to AVIATION, 42 Avenue Montaigne to facilitate the acquisition or attempted the shares until otherwise required by 75008, Paris, France; SIRJANCO acquisition from a Denied Person of any Mahan’’ but would ‘‘exercise the rights TRADING LLC, P.O. Box 8709, Dubai, item subject to the EAR that has been granted to [him] exactly and only as United Arab Emirates; ALI ESLAMIAN, exported from the United States; instructed by Mahan and [his] vote and/ 4th Floor, 33 Cavendish Square, London D. Obtain from a Denied Person in the or decisions [would] only and W1G0PW, United Kingdom, and 2 United States any item subject to the exclusively reflect the wills and Bentinck Close, Prince Albert Road St. EAR with knowledge or reason to know demands of Mahan[.]’’ Johns Wood, London NW87RY, United that the item will be, or is intended to Kingdom; MAHAN AIR GENERAL be, exported from the United States; or C. Findings TRADING LLC, 19th Floor Al Moosa E. Engage in any transaction to service Under the applicable standard set Tower One, Sheik Zayed Road, Dubai any item subject to the EAR that has forth in Section 766.24 of the 40594, United Arab Emirates; SKYCO been or will be exported from the Regulations and my review of the entire (UK) LTD., 4th Floor, 33 Cavendish United States and which is owned, record, I find that the evidence Square, London, W1G 0PV, United possessed or controlled by a Denied presented by BIS convincingly Kingdom; EQUIPCO (UK) LTD., 2 Person, or service any item, of whatever demonstrates that Mahan Airways has Bentinck Close, Prince Albert Road, origin, that is owned, possessed or continually violated the EAR and the London, NW8 7RY, United Kingdom; controlled by a Denied Person if such TDO, that such knowing violations have and MEHDI BAHRAMI, Mahan service involves the use of any item been significant, deliberate and covert, Airways- Istanbul Office, Cumhuriye subject to the EAR that has been or will and that there is a likelihood of future Cad. Sibil Apt No: 101 D:6, 34374 be exported from the United States. For violations. The record includes further Emadad, Sisli Istanbul, Turkey; and purposes of this paragraph, servicing evidence uncovered by OEE since the when acting for or on their behalf, any means installation, maintenance, repair, February 4, 2013 Order about the successors or assigns, agents, or modification or testing. continued use of jet aircraft and on- employees (each a ‘‘Denied Person’’ and Third, that, after notice and going measures Mahan Airways has collectively the ‘‘Denied Persons’’) may opportunity for comment as provided in taken in concert with its far-reaching not, directly or indirectly, participate in section 766.23 of the EAR, any other network of affiliates and agents to any way in any transaction involving person, firm, corporation, or business procure EAR items in violation of the any commodity, software or technology organization related to a Denied Person TDO and the Regulations. Therefore, (hereinafter collectively referred to as by affiliation, ownership, control, or renewal of the TDO is necessary to ‘‘item’’) exported or to be exported from position of responsibility in the conduct prevent imminent violation of the EAR the United States that is subject to the of trade or related services may also be and to give notice to companies and Export Administration Regulations made subject to the provisions of this individuals in the United States and (‘‘EAR’’), or in any other activity subject Order. abroad that they should continue to to the EAR including, but not limited to: Fourth, that this Order does not cease dealing with Mahan Airways, A. Applying for, obtaining, or using prohibit any export, reexport, or other Zarand Aviation, and the other denied any license, License Exception, or transaction subject to the EAR where the persons under the TDO in export export control document; only items involved that are subject to transactions involving items subject to B. Carrying on negotiations the EAR are the foreign-produced direct the EAR. concerning, or ordering, buying, product of U.S.-origin technology. In accordance with the provisions of IV. ORDER receiving, using, selling, delivering, storing, disposing of, forwarding, Sections 766.24(e) of the EAR, Mahan It is therefore ordered: transporting, financing, or otherwise Airways and/or Zarand Aviation may, at First, that MAHAN AIRWAYS, Mahan servicing in any way, any transaction any time, appeal this Order by filing a Tower, No. 21, Azadegan St., M.A. involving any item exported or to be full written statement in support of the Jenah Exp. Way, Tehran, Iran; ZARAND exported from the United States that is appeal with the Office of the AVIATION A/K/A GIE ZARAND subject to the EAR, or in any other Administrative Law Judge, U.S. Coast AVIATION, 42 Avenue Montaigne, activity subject to the EAR; or Guard ALJ Docketing Center, 40 South 75008 Paris, France, and 112 Avenue C. Benefitting in any way from any Gay Street, Baltimore, Maryland 21202– Kleber, 75116 Paris, France; GATEWICK transaction involving any item exported 4022. In accordance with the provisions LLC, A/K/A GATEWICK FREIGHT & or to be exported from the United States of Sections 766.23(c)(2) and 766.24(e)(3) CARGO SERVICES, A/K/A GATEWICK that is subject to the EAR, or in any of the EAR, Gatewick LLC, Mahmoud AVIATION SERVICE, G#22 Dubai other activity subject to the EAR. Amini, Pejman Mahmood Airport Free Zone, P.O. Box 393754, Second, that no person may, directly Kosarayanifard, Kerman Aviation, Dubai, United Arab Emirates, and P.O. or indirectly, do any of the following: Sirjanco Trading LLC, Ali Eslamian, Box 52404, Dubai, United Arab A. Export or reexport to or on behalf Mahan Air General Trading LLC, Skyco Emirates, and Mohamed Abdulla Alqaz of a Denied Person any item subject to (UK) Ltd., Equipco (UK) Ltd., and/or Building, Al Maktoum Street, Al Rigga, the EAR; Mehdi Bahrami may, at any time, appeal Dubai, United Arab Emirates; PEJMAN B. Take any action that facilitates the their inclusion as a related person by MAHMOOD KOSARAYANIFARD A/K/ acquisition or attempted acquisition by filing a full written statement in support A KOSARIAN FARD, P.O. Box 52404, a Denied Person of the ownership, of the appeal with the Office of the Dubai, United Arab Emirates; possession, or control of any item Administrative Law Judge, U.S. Coast MAHMOUD AMINI, G#22 Dubai subject to the EAR that has been or will Guard ALJ Docketing Center, 40 South Airport Free Zone, P.O. Box 393754, be exported from the United States, Gay Street, Baltimore, Maryland 21202– Dubai, United Arab Emirates, and P.O. including financing or other support 4022. Box 52404, Dubai, United Arab activities related to a transaction In accordance with the provisions of Emirates, and Mohamed Abdulla Alqaz whereby a Denied Person acquires or Section 766.24(d) of the EAR, BIS may

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seek renewal of this Order by filing a I. Abstract either: (A) a domestic producer or written request not later than 20 days Title III, Subtitle B, Section 321 producers of an article that is like or before the expiration date. A renewal through Section 328 of the United directly competitive with the subject request may be opposed by Mahan States-Peru Free Trade Agreement Peruvian textile or apparel article; or (B) Airways and/or Zarand Aviation as Implementation Act (the ‘‘Act’’) a domestic producer or producers of a provided in Section 766.24(d), by filing implements the textile and apparel component used in the production of an a written submission with the Assistant safeguard provisions, provided for in article that is like or directly Secretary of Commerce for Export Article 3.1 of the United States-Peru competitive with the subject Peruvian Enforcement, which must be received Free Trade Agreement (the textile or apparel article. not later than seven days before the ‘‘Agreement’’). This safeguard In order for a request to be expiration date of the Order. mechanism applies when, as a result of considered, the requestor must provide A copy of this Order shall be provided the elimination of a customs duty under the following information in support of to Mahan Airways, Zarand Aviation and the Agreement, a Peruvian textile or a claim that a textile or apparel article each related person, and shall be apparel article is being imported into from Peru is being imported into the published in the Federal Register. This the United States in such increased United States in such increased Order is effective immediately and shall quantities, in absolute terms or relative quantities, in absolute terms or relative remain in effect for 180 days. to the domestic market for that article, to the domestic market for that article, Dated: July 31, 2013. and under such conditions as to cause and under such conditions as to cause David W. Mills, serious damage or actual threat thereof serious damage or actual threat thereof, Assistant Secretary of Commerce for Export to a U.S. industry producing a like or to a U.S. industry producing an article Enforcement. directly competitive article. In these that is like, or directly competitive with, [FR Doc. 2013–19043 Filed 8–6–13; 8:45 a.m.] circumstances, Article 3.1 permits the the imported article: (1) name and description of the imported article BILLING CODE P United States to increase duties on the imported article from Peru to a level concerned; (2) import data that does not exceed the lesser of the demonstrating that imports of a DEPARTMENT OF COMMERCE prevailing U.S. normal trade relations Peruvian origin textile or apparel article (NTR)/most-favored-nation (MFN) duty that are like or directly competitive with International Trade Administration rate for the article or the U.S. NTR/MFN the articles produced by the domestic duty rate in effect on the day before the industry concerned are increasing in Proposed Information Collection; Agreement entered into force. absolute terms or relative to the Comment Request; Procedures for The Statement of Administrative domestic market for that article; (3) U.S. Considering Requests and Comments Action accompanying the Act provides domestic production of the like or From the Public Under the Textile that the Committee for the directly competitive articles of U.S. Safeguard Provision of the United Implementation of Textile Agreements origin indicating the nature and extent States–Peru Free Trade Agreement (CITA) will issue procedures for of the serious damage or actual threat thereof, along with an affirmation that to AGENCY: International Trade requesting such safeguard measures, for Administration (ITA). making its determinations under the best of the requestor’s knowledge, the data represent substantially all of ACTION: Notice. Section 322(a) of the Act, and for providing relief under section 322(b) of the domestic production of the like or SUMMARY: The Department of the Act. directly competitive article(s) of U.S. Commerce, as part of its continuing In Proclamation No. 8341 (74 FR origin; (4) imports from Peru as a effort to reduce paperwork and 4105, January 22, 2009), the President percentage of the domestic market of the respondent burden, invites the general delegated to CITA his authority under like or directly competitive article(s); public and other Federal agencies to Subtitle B of Title III of the Act with and (5) all data available to the take this opportunity to comment on respect to textile and apparel safeguard requestor showing changes in proposed and/or continuing information measures. productivity, utilization of capacity, collections, as required by the CITA must collect information in inventories, exports, wages, Paperwork Reduction Act of 1995. order to determine whether a domestic employment, domestic prices, profits, and investment, and any other DATES: Written comments must be textile or apparel industry is being submitted on or before October 7, 2013. adversely impacted by imports of these information, relating to the existence of products from Peru, thereby allowing serious damage or actual threat thereof ADDRESSES: Direct all written comments CITA to take corrective action to protect caused by imports from Peru to the to Jennifer Jessup, Departmental industry producing the like or directly Paperwork Clearance Officer, the viability of the domestic textile industry, subject to section 322(b) of the competitive article that is the subject of Department of Commerce, Room 6616, the request. To the extent that such 14th and Constitution Avenue NW, Act. Pursuant to Section 321(a) of the Act information is not available, the Washington, DC 20230 (or via the and Section 9 of Presidential requestor should provide best estimates Internet at [email protected]). Proclamation 8341, an interested party and the basis therefore. FOR FURTHER INFORMATION CONTACT: in the U.S. domestic textile and apparel If CITA determines that the request Requests for additional information or industry may file a request for a textile provides the information necessary for it copies of the information collection and apparel safeguard action with CITA. to be considered, CITA will publish a instrument and instructions should be Consistent with longstanding CITA notice in the Federal Register seeking directed to Laurie Mease, Office of practice in considering textile safeguard public comments regarding the request. Textiles and Apparel, U.S. Department actions, CITA will consider an The comment period shall be 30 of Commerce, Telephone: 202–482– interested party to be an entity (which calendar days. The notice will include 3400, Fax: 202–482–0858, Email: may be a trade association, firm, a summary of the request. Any [email protected]. certified or recognized union, or group interested party may submit information SUPPLEMENTARY INFORMATION: of workers) that is representative of to rebut, clarify, or correct public

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comments submitted by any interested Estimated Number of Respondents: 6 as the mandatory respondents while party. (1 for Request; 5 for Comments). Polyplex is the non-selected respondent. CITA will make a determination on Estimated Time Per Response: 4 hours The Department preliminarily any request it considers within 60 for a Request; and 4 hours for each determines that SRF did, and that Jindal calendar days of the close of the Comment. did not, make sales of subject comment period. If CITA is unable to Estimated Total Annual Burden merchandise at prices below normal make a determination within 60 Hours: 24. value (NV) during the POR. The calendar days, it will publish a notice in Estimated Total Annual Cost to preliminary results are listed below in the Federal Register, including the date Public: $960. the section titled ‘‘Preliminary Results it will make a determination. of Review.’’ Interested parties are If a determination under Section IV. Request for Comments invited to comment on these 322(a) of the Act is affirmative, CITA Comments are invited on: (a) whether preliminary results. may provide tariff relief to a U.S. the proposed collection of information DATES: Effective Date: August 7, 2013. industry to the extent necessary to is necessary for the proper performance FOR FURTHER INFORMATION CONTACT: Elfi remedy or prevent serious damage or of the functions of the agency, including Blum or Toni Page, AD/CVD actual threat thereof and to facilitate whether the information shall have Operations, Office 6, Import adjustment by the domestic industry to practical utility; (b) the accuracy of the Administration, International Trade import competition. The import tariff agency’s estimate of the burden Administration, U.S. Department of relief is effective beginning on the date (including hours and cost) of the Commerce, 14th Street and Constitution that CITA’s affirmative determination is proposed collection of information; (c) Avenue NW., Washington, DC 20230; published in the Federal Register. ways to enhance the quality, utility, and telephone: (202) 482–0197 or (202) 482– Entities submitting requests, responses clarity of the information to be 1398, respectively. or rebuttals to CITA may submit both a collected; and (d) ways to minimize the SUPPLEMENTARY INFORMATION: public and confidential version of their burden of the collection of information submissions. If the request is accepted, on respondents, including through the Scope of the Order the public version will be posted on the use of automated collection techniques The products covered by the dedicated U.S.-Peru Free Trade or other forms of information antidumping duty order are all gauges of Agreement textile safeguards section of technology. raw, pretreated, or primed PET Film, the Office of Textiles and Apparel Comments submitted in response to whether extruded or coextruded. (OTEXA) Web site. The confidential this notice will be summarized and/or Excluded are metallized films and other version of the request, responses or included in the request for OMB finished films that have had at least one rebuttals will not be shared with the approval of this information collection; of their surfaces modified by the public as they may contain business they also will become a matter of public application of a performance-enhancing confidential information. Entities record. resinous or inorganic layer of more than submitting responses or rebuttals may Dated: August 1, 2013. 0.00001 inches thick. Imports of PET use the public version of the request as Gwellnar Banks, Film are currently classifiable in the a basis for responses. Management Analyst, Office of the Chief Harmonized Tariff Schedule of the II. Method of Collection Information Officer. United States (HTSUS) under item [FR Doc. 2013–18963 Filed 8–6–13; 8:45 am] number 3920.62.00.90. HTSUS When an interested party files a subheadings are provided for BILLING CODE 3510–DR–P request for a textile and apparel convenience and customs purposes. The safeguard action with CITA, ten copies written description of the scope of the of any such request must be provided in antidumping duty order is dispositive. a paper format. If business confidential DEPARTMENT OF COMMERCE Methodology information is provided, two copies of International Trade Administration a non-confidential version must also be The Department has conducted this provided. If CITA determines that the [A–533–824] review in accordance with section request provides the necessary 751(a) of the Tariff Act of 1930, as Polyethylene Terephthalate Film, information to be considered, it amended (the Act). Export price and Sheet, and Strip From India: publishes a Federal Register notice constructed export price are calculated Preliminary Results of Antidumping seeking public comments on the in accordance with section 772 of the Duty Administrative Review; 2011– request. Act. NV is calculated in accordance 2012 To the extent business confidential with section 773 of the Act. For a full information is provided, a non- AGENCY: Import Administration, description of the methodology confidential version must also be International Trade Administration, underlying our conclusions, see the provided. Any interested party may Department of Commerce. Preliminary Decision Memorandum, submit information to rebut, clarify, or 1 SUMMARY: The Department of Commerce which is hereby adopted by this notice. correct public comments submitted by The Preliminary Decision Memorandum any interested party. (the Department) is conducting an administrative review of the is a public document and is on file III. Data antidumping duty order on electronically via Import polyethylene terephthalate film, sheet, OMB Control Number: 0625–0267. 1 See Memorandum from Christian Marsh, Deputy Form Number(s): None. and strip (PET Film) from India. The Assistant Secretary for Antidumping and Type of Review: Regular submission period of review (POR) is July 1, 2011, Countervailing Duty Operations, to Paul Piquado, (extension of a currently approved through June 30, 2012. This review Assistant Secretary for Import Administration information collection). covers three respondents, Jindal Poly ‘‘Decision Memorandum for the Preliminary Results of Antidumping Duty Administrative Review: Affected Public: Individuals or Films Limited (Jindal), SRF Limited Polyethylene Terephthalate Film, Sheet, and Strip households; business or other for-profit (SRF), and Polyplex Corporation Ltd. from India,’’ dated concurrently with this notice organizations. (Polyplex). Jindal and SRF were selected (Preliminary Decision Memorandum).

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Administration’s Antidumping and Weighted- merchandise produced and/or exported Countervailing Duty Centralized Manufacturer/exporter average by Jindal, SRF, and Polyplex. The Electronic Service System (IA ACCESS). margin Department intends to issue assessment (percent) IA ACCESS is available to registered instructions to CBP 15 days after the users at http://iaaccess.trade.gov and in Jindal Poly Films Limited ...... 0.00 date of publication of the final results of the Central Records Unit, room 7046 of SRF Limited ...... 0.71 review. For assessment purposes, where the main Department of Commerce Polyplex Corporation Ltd ...... 0.71 the respondent reported the entered building. In addition, a complete value for its sales, we calculated version of the Preliminary Decision Disclosure and Public Comment importer-specific (or customer-specific) ad valorem assessment rates based on Memorandum can be accessed directly The Department will disclose to the ratio of the total amount of the on the Internet at http://www.trade.gov/ parties the calculations performed in dumping duties calculated for the connection with these preliminary ia/. The signed Preliminary Decision examined sales to the total entered results within five days of the date of Memorandum and the electronic value of those same sales.10 However, publication of this notice.3 Interested versions of the Preliminary Decision where the respondent did not report the parties may submit case briefs not later Memorandum are identical in content. entered value for its sales, we will than 30 days after the date of calculate importer-specific (or customer- Non-Selected Respondent publication of this notice.4 Rebuttal specific) per-unit duty assessment rates. briefs, limited to issues raised in the With regard to determining an We will instruct CBP to assess case briefs, may be filed not later than antidumping duties on all appropriate appropriate rate to be applied to the five days after the date for filing case entries covered by this review if any non-selected respondent Polyplex, the briefs.5 Parties who submit case briefs or per-unit duty assessment rate calculated statute and the Department’s regulations rebuttal briefs in this proceeding are in the final results of this review is do not directly address the encouraged to submit with each above de minimis (i.e., at or above 0.50 establishment of a rate to be applied to argument: (1) A statement of the issue; percent). For any individually examined companies not selected for individual (2) a brief summary of the argument; respondents whose weighted-average examination where the Department and (3) a table of authorities.6 Case and dumping margin is above de minimis in limited its examination in an rebuttal briefs should be filed using IA the final results, we will calculate administrative review pursuant to ACCESS.7 importer-specific ad valorem duty section 777A(c)(2) of the Act. The Interested parties who wish to request a hearing, or to participate if one is assessment rates based on the ratio of Department’s practice in cases involving the total amount of antidumping duties limited selection of respondents has requested, must submit a written request to the Assistant Secretary for calculated for the importer’s examined been to look for guidance in section sales to the total entered value of the 735(c)(5) of the Act, which provides Import Administration, filed electronically via IA ACCESS.8 An sales in accordance with 19 CFR instructions for calculating the all- 351.212(b)(1). Pursuant to 19 CFR others rate in an investigation. The electronically-filed document must be received successfully in its entirety by 351.106(c)(2), we intend to instruct CBP Department generally weight-averages the Department’s electronic records to liquidate without regard to the rates calculated for the mandatory system, IA ACCESS, by 5:00 p.m. antidumping duties any entries for respondents, excluding zero and de which the assessment rate is zero or de Eastern Standard Time within 30 days 11 minimis rates and rates based entirely after the date of publication of this minimis (i.e., less than 0.50 percent). on facts available, and applies that notice.9 Requests should contain: (1) Cash Deposit Requirements resulting weighted-average margin to The party’s name, address, and non-selected respondents.2 The following deposit requirements telephone number; (2) the number of will be effective for all shipments of In this review, we have preliminarily participants; and (3) a list of issues to be PET Film from India entered, or calculated a zero or de minimis discussed. Issues raised in the hearing withdrawn from warehouse, for weighted-average dumping margin for will be limited to those raised in the consumption on or after the date of mandatory respondent Jindal and an respective case briefs. The Department publication of the final results of this above de minimis rate for the other will issue the final results of this administrative review, as provided for mandatory respondent, SRF. Based on administrative review, including the by section 751(a)(2)(C) of the Act: (1) this, we have based the dumping margin results of its analysis of issues raised in The cash deposit rate for the company for Polyplex on the above de minimis any written briefs, not later than 120 under review will be the rate rate calculated for SRF. days after the date of publication of this established in the final results of this notice, pursuant to section 751(a)(3)(A) review (except, if the rate is zero or de Preliminary Results of Review of the Act, unless that time is extended. minimis, i.e., less than 0.5 percent, no We preliminarily determine the Assessment Rates cash deposit will be required); (2) for previously reviewed or investigated following weighted-average dumping The Department shall determine, and companies not listed above, the cash margins exist for the period July 1, 2011, U.S. Customs and Border Protection deposit rate will continue to be the through June 30, 2012. (CBP) shall assess, antidumping duties company-specific rate published for the on all appropriate entries. We will most recent period; (3) if the exporter is 2 See, e.g., Wooden Bedroom Furniture From the instruct CBP to liquidate entries of People’s Republic of China: Preliminary Results of not a firm covered in this review, a prior review, or the less-than-fair-value Antidumping Duty Administrative Review, 3 See 19 CFR 351.224(b). Preliminary Results of New Shipper Review and 4 See 19 CFR 351.309(c). investigation, but the manufacturer is, Partial Rescission of Administrative Review, 73 FR 5 See 19 CFR 351.309(d). the cash deposit rate will be the rate 8273 (February 13, 2008), unchanged in Wooden 6 established for the most recent period Bedroom Furniture from the People’s Republic of See 19 CFR 351.309(c)(2) and (d)(2). China: Final Results of Antidumping Duty 7 See 19 CFR 351.303. Administrative Review and New Shipper Review, 73 8 See 19 CFR 351.310(c). 10 See 19 CFR 351.212(b). FR 49162 (August 20, 2008). 9 Id. 11 See 19 CFR 351.106(c)(1).

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for the manufacturer of the publishing notice of the continuation of concentration, brix level, brix/acid ratio, merchandise; and (4) if neither the this suspended antidumping duty pulp content, clarity, grade, horticulture exporter nor the manufacturer is a firm investigation. method (e.g., organic or not), processed covered in this or any previous review, DATES: Effective Date: August 7, 2013. form (e.g., frozen or not-from- the cash deposit rate will be the all concentrate), FDA standard of identity, FOR FURTHER INFORMATION CONTACT: others rate for this proceeding, 5.71 the size of the container in which Anne D’Alauro or Judith Wey Rudman, percent. These deposit requirements, packed, or the method of packing. Import Administration, International when imposed, shall remain in effect Trade Administration, U.S. Department Excluded from the scope are: (1) until further notice. of Commerce, 14th Street and Lemon juice at any level of Notification to Importers Constitution Avenue NW., Washington, concentration packed in retail-sized containers ready for sale to consumers, This notice also serves as a DC 20230; telephone (202) 482–4830 or typically at a level of concentration of preliminary reminder to importers of (202) 482–0192, respectively. 48 GPL; and (2) beverage products such their responsibility under 19 CFR SUPPLEMENTARY INFORMATION: as lemonade that typically contain 20% 351.402(f) to file a certificate regarding Background or less lemon juice as an ingredient. the reimbursement of antidumping duties prior to liquidation of the On August 1, 2012, the Department Lemon juice is classifiable under relevant entries during this review initiated, and the ITC instituted, a subheadings 2009.39.6020, period. Failure to comply with this sunset review of the suspended 2009.31.6020, 2009.31.4000, requirement could result in the antidumping duty investigation on 2009.31.6040, and 2009.39.6040 of the Department’s presumption that lemon juice from Argentina Harmonized Tariff Schedule of the reimbursement of antidumping duties (‘‘suspended investigation’’), pursuant United States (HTSUS). While HTSUS occurred and the subsequent assessment to section 751(c) of the Tariff Act of subheadings are provided for of double antidumping duties. 1930, as amended (‘‘the Act’’). See convenience and customs purposes, our We are issuing and publishing these Initiation of Five-year (‘‘Sunset’’) Review written description of the scope of the results in accordance with sections and Correction, 77 FR 45589 (August 1, suspended investigation is dispositive. 751(a)(1) and 777(i)(1) of the Act. 2012) and [Investigation Nos. 731–TA– 1105–1106 (Review)] Lemon Juice from Continuation of the Suspended Dated: July 31, 2013 . Argentina and Mexico, 77 FR 45653 Investigation Paul Piquado, (August 1, 2012). As a result of its As a result of the respective Assistant Secretary for Import review, the Department determined that determinations by the Department and Administration. termination of the suspended the ITC that termination of the investigation on lemon juice from Appendix suspended investigation on lemon juice Argentina would likely lead to a from Argentina would likely lead to List of Topics Discussed in the Preliminary continuation or recurrence of dumping continuation or recurrence of dumping Decision Memorandum and notified the ITC of the magnitude of and material injury to an industry in the 1. Scope of the Order the margins likely to prevail, should the United States, pursuant to section 2. Date of Sale suspended investigation be terminated. 751(d)(2) of the Act, the Department 3. Discussion of Methodology See Lemon Juice from Argentina; Final hereby gives notice of the continuation 4. Product Comparisons Results of the Expedited First Sunset 5. Export Price and Constructed Export Price of the suspended investigation on lemon Review of the Suspended Antidumping 6. Normal Value juice from Argentina. The effective date Duty Investigation, 77 FR 73021 7. Cost of Production Analysis of continuation will be the date of 8. Currency Conversion (December 7, 2012). On July 10, 2013, pursuant to section publication in the Federal Register of [FR Doc. 2013–19096 Filed 8–6–13; 8:45 am] 751(c) of the Act, the ITC determined this Continuation Notice. Because the BILLING CODE 3510–DS–P that termination of the suspended Department is continuing the suspended investigation on lemon juice from investigation, the suspension agreement will also continue to remain in effect. DEPARTMENT OF COMMERCE Argentina would be likely to lead to continuation or recurrence of material See Suspension of Antidumping Duty Investigation: Lemon Juice From International Trade Administration injury to an industry in the United States within a reasonably foreseeable Argentina, 72 FR 53991 (September 21, [A–357–818] time. See Lemon Juice from Argentina, 2007). Pursuant to sections 751(c)(2) of the Act, the Department intends to Lemon Juice From Argentina: 78 FR 46610 (August 1, 2013). Therefore, pursuant to section initiate the next five-year sunset review Continuation of Suspended of the suspended investigation on lemon Antidumping Duty Investigation 351.218(f)(4) of the Department’s regulations, the Department is juice from Argentina not later than 30 AGENCY: Import Administration, publishing this notice of the days prior to the fifth anniversary of the International Trade Administration, continuation of the suspended effective date of continuation. Department of Commerce. investigation on lemon juice from This five-year (sunset) review and SUMMARY: As a result of the Argentina. notice are in accordance with section determination by the Department of 751(c) of the Act and published Commerce (‘‘the Department’’) and the Scope pursuant to section 777(i)(1) of the Act. International Trade Commission (‘‘ITC’’) The merchandise covered by the Dated: August 1, 2013. that termination of the suspended suspended investigation includes investigation on lemon juice from certain lemon juice for further Paul Piquado, Argentina would likely lead to manufacture, with or without addition Assistant Secretary for Import continuation or recurrence of dumping, of preservatives, sugar, or other Administration. and material injury to an industry in the sweeteners, regardless of the GPL (grams [FR Doc. 2013–19067 Filed 8–6–13; 8:45 am] United States, the Department is per liter of citric acid) level of BILLING CODE 3510–DS–P

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DEPARTMENT OF COMMERCE The merchandise subject to review is the period July 1, 2011, through June 30, currently classifiable under items 2012: International Trade Administration 1901.90.90.95 and 1902.19.20 of the Harmonized Tariff Schedule of the Weighted- [A–475–818] average United States (HTSUS). Although the Producer and/or exporter dumping Certain Pasta From Italy: Antidumping HTSUS subheadings are provided for margin Duty Administrative Review; 2011– convenience and customs purposes, the (percent) 2012 written description of the merchandise subject to the order is dispositive.3 Pastificio Gallo Natale & F.lli AGENCY: Import Administration, S.r.L ...... 2.48 International Trade Administration, SUPPLEMENTARY INFORMATION: Rummo S.p.A. Molino e Department of Commerce. Methodology Pastificio, Rummo S.p.A., SUMMARY: In response to requests from Lenta Lavorazione, and The Department has conducted this Pasta Castiglioni ...... 18.82 interested parties, the Department of review in accordance with section Alberto Poiatti S.p.A ...... 16.95 Commerce (the Department) is 751(a)(2) of the Tariff Act of 1930, as Delverde Industrie Alimentari conducting an administrative review of amended (the Act). Constructed export S.p.A ...... 16.95 the antidumping duty order on certain price or Export Price is calculated in Fiamma Vesuviana S.r.L ...... 16.95 pasta (pasta) from Italy,1 covering the Pastificio Zaffiri S.r.L ...... 16.95 accordance with section 772 of the Act. period July 1, 2011, through June 30, Tandoi Filippo e Adalberto Normal Value is calculated in 2012. The review covers two mandatory Fratelli S.p.A ...... 16.95 accordance with section 773 of the Act. respondents, Pastificio Gallo Natale & Valdigrano di Flavio Pagani For a full description of the F.lli S.r.L. (Gallo) and Rummo S.p.A. S.r.L ...... 16.95 methodology underlying our Molino e Pastificio and its affiliates preliminary results, see Preliminary Rummo S.p.A., Lenta Lavorazione, and Disclosure and Public Comment Decision Memorandum dated Pasta Castiglioni (collectively, Rummo), The Department will disclose to concurrently with this notice and and six non-selected companies.2 We parties to this proceeding the hereby adopted by this notice. The preliminarily determine that Gallo and calculations performed in reaching the Preliminary Decision Memorandum is a Rummo made sales of subject preliminary results within five days of public document and is on file merchandise at less than normal value the date of publication of these during the period of review (POR). electronically via Import preliminary results.5 The Department Interested parties are invited to Administration’s Antidumping and will announce the briefing schedule to comment on these preliminary results. Countervailing Duty Centralized interested parties at a later date. Electronic Service System (IA ACCESS). DATES: Effective Date: August 7, 2013. Interested parties may submit written IA ACCESS is available to registered comments (case briefs) on the deadline FOR FURTHER INFORMATION CONTACT: users at http://iaaccess.trade.gov, and is Stephanie Moore (Gallo) or George that the Department will announce and available to all parties in the Central rebuttal comments (rebuttal briefs) McMahon (Rummo), AD/CVD Records Unit, room 7046 of the main Operations, Office 8, Import within five days after the time limit for Department of Commerce building. In filing case briefs.6 Pursuant to 19 CFR Administration, International Trade addition, a complete version of the Administration, U.S. Department of 351.309(d)(2), rebuttal briefs must be Preliminary Decision Memorandum can limited to issues raised in the case Commerce, 14th Street and Constitution be accessed directly on the internet at Avenue NW., Washington, DC 20230; briefs. Parties who submit comments are http://www.trade.gov/ia/. The signed requested to submit: (1) A statement of telephone: (202) 482–3692 or (202) 482– Preliminary Decision Memorandum and 1167, respectively. the issue; (2) a brief summary of the the electronic versions of the argument; and (3) a table of authorities. Scope of the Order Preliminary Decision Memorandum are All briefs must be filed electronically Imports covered by the order are identical in content. using IA ACCESS. An electronically shipments of certain non-egg dry pasta. Preliminary Results of the Review filed document must be received successfully in its entirety by the As a result of this review, we 1 See Notice of Antidumping Duty Order and Department’s electronic records system, preliminarily determine the following Amended Final Determination of Sales at Less IA ACCESS. Than Fair Value: Certain Pasta From Italy, 61 FR weighted-average dumping margins 4 for 38547 (July 24, 1996) (AD Order). Interested parties who wish to request 2 The non-selected companies are: Alberto Poiatti a hearing, or to participate if one is 3 S.p.A (Poiatti); Delverde Industrie Alimentari S.p.A For a full description of the scope of the order, requested, must submit a written see the ‘‘Decision Memorandum for the Preliminary (Delverde); Fiamma Vesuviana S.r.L (Fiamma); request to the Assistant Secretary for Pastificio Zaffiri S.r.L (Zaffiri); Tandoi Filippo e Results of Antidumping Duty Administrative Adalberto Fratelli S.p.A (Tandoi); and Valdigrano Review: Certain Pasta from Italy’’ from Christian Import Administration, U.S. Department di Flavio Pagani S.r.L (Valdigrano). The Department Marsh, Deputy Assistant Secretary for Antidumping of Commerce, using Import is currently conducting a changed circumstances and Countervailing Duty Operations, to Paul Administration’s IA ACCESS system.7 Piquado, Assistant Secretary for Import review of Delverde to determine whether Delverde Requests should contain the party’s is the successor-in-interest to a company that was Administration, dated concurrently with this notice excluded from the AD Order. The Department (Preliminary Decision Memorandum). name, address, and telephone number, issued a partial rescission notice in which it 4 The rate applied to the non-selected companies the number of participants, and a list of rescinded this administrative review, in part, with is a weighted-average percentage margin calculated the issues to be discussed. If a request respect to Industria Alimentare Colavita, S.p.A based on the publicly-ranged U.S. volumes of the for a hearing is made, we will inform (Indalco) and Pasta Lensi S.r.L (Lensi). We also two reviewed companies with an affirmative rescinded, in part, this administrative review with dumping margin, for the period July 1, 2011, parties of the scheduled date for the respect to Pastificio Attilio Mastromauro-Pasta through June 30, 2012. See Memorandum to the hearing which will be held at the U.S. Granoro S.r.L (Granoro) because this company has File, titled, ‘‘Certain Pasta from Italy: Margin for Department of Commerce, 14th Street been revoked from the antidumping duty order Respondents Not Selected for Individual effective prior to the beginning of this period of Examination,’’ from George McMahon and review. See Certain Pasta From Italy: Notice of Stephanie Moore, Case Analysts, through Eric B. 5 See 19 CFR 351.224(b). Partial Rescission of Antidumping Duty Greynolds, Program Manager, dated concurrently 6 See 19 CFR 351.309(c)(1)(ii) and (d)(1). Administrative Review, 78 FR 20091 (April 3, 2013). with this notice. 7 See 19 CFR 351.310(c).

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and Constitution Avenue NW., We intend to issue instructions to Dated: July 30, 2013. Washington, DC 20230, at a time and CBP 15 days after publication of the Paul Piquado, location to be determined.8 Parties final results of this review. Assistant Secretary for Import should confirm by telephone the date, Administration. Cash Deposit Requirements time, and location of the hearing. The following cash deposit Appendix—List of Topics Discussed in Unless the deadline is extended the Preliminary Decision Memorandum pursuant to section 751(a)(2)(B)(iv) of requirements will be effective upon the Act, the Department will issue the publication of the notice of final results 1. Background final results of this administrative of administrative review for all 2. Scope of the Order review, including the results of our shipments of subject merchandise 3. Discussion of Methodology analysis of the issues raised by the entered, or withdrawn from warehouse, [FR Doc. 2013–19102 Filed 8–6–13; 8:45 am] parties in their case briefs, within 120 for consumption on or after the BILLING CODE 3510–DS–P days after issuance of these preliminary publication of the final results of this results. administrative review, as provided by section 751(a)(2) of the Act: (1) The cash DEPARTMENT OF COMMERCE Assessment Rate deposit rate for respondents noted above Upon issuance of the final results, the will be the rate established in the final International Trade Administration results of this administrative review; (2) Department shall determine, and U.S. [C–533–825] Customs and Border Protection (CBP) for merchandise exported by shall assess, antidumping duties on all manufacturers or exporters not covered Polyethylene Terephthalate Film, appropriate entries covered by this in this administrative review but Sheet, and Strip From India: review. If the weighted-average covered in a prior segment of the Preliminary Results of Countervailing proceeding, the cash deposit rate will dumping margin for Gallo or Rummo is Duty Administrative Review; 2011 not zero or de minimis (i.e., less than 0.5 continue to be the company-specific rate published for the most recently percent), we will calculate importer- AGENCY: Import Administration, completed segment of this proceeding; specific ad valorem antidumping duty International Trade Administration, (3) if the exporter is not a firm covered assessment rates based on the ratio of Department of Commerce. in this review, a prior review, or the the total amount of dumping calculated SUMMARY: The Department of Commerce original investigation, but the for the importer’s examined sales to the (the Department) is conducting an manufacturer is, the cash deposit rate total entered value of those same sales administrative review under the will be the rate established for the most in accordance with 19 CFR countervailing duty (CVD) order on recently completed segment of this 351.212(b)(1). We will instruct CBP to polyethylene terephthalate film, sheet proceeding for the manufacturer of the assess antidumping duties on all and strip (PET film) from India for the subject merchandise; and (4) the cash appropriate entries covered by this period of review (POR) January 1, 2011, deposit rate for all other manufacturers review when the importer-specific through December 31, 2011. We or exporters will continue to be 15.45 assessment rate calculated in the final preliminarily determine that SRF percent, the all-others rate established results of this review is not zero or de Limited (SRF) has received in the antidumping investigation as minimis. Where either the respondent’s countervailable subsidies during the modified by the section 129 weighted-average dumping margin is POR. See the ‘‘Preliminary Results of determination.9 These cash deposit zero or de minimis, or an importer- Review’’ section, below. requirements, when imposed, shall specific assessment rate is zero or de DATES: remain in effect until further notice. Effective Date: August 7, 2013. minimis, we will instruct CBP to FOR FURTHER INFORMATION CONTACT: Elfi liquidate the appropriate entries Notification to Importers Blum or Toni Page, AD/CVD without regard to antidumping duties. This notice serves as a preliminary Operations, Office 6, Import The final results of this review shall be reminder to importers of their Administration, International Trade the basis for the assessment of responsibility under 19 CFR Administration, U.S. Department of antidumping duties on entries of 351.402(f)(2) to file a certificate Commerce, 14th Street and Constitution merchandise covered by the final results regarding the reimbursement of Avenue NW., Washington, DC 20230; of this review where applicable. antidumping duties prior to liquidation telephone: (202) 482–0197 or (202) 482– The Department clarified its of the relevant entries during this 1398, respectively. ‘‘automatic assessment’’ regulation on review period. Failure to comply with Scope of the Order May 6, 2003. This clarification will this requirement could result in the apply to entries of subject merchandise Secretary’s presumption that For purposes of the order, the during the POR produced by each reimbursement of antidumping duties products covered are all gauges of raw, respondent for which they did not know occurred and increase the subsequent pretreated, or primed polyethylene that their merchandise was destined for assessment of the antidumping duties terephthalate film, sheet and strip, the United States. In such instances, we by the amount of antidumping duties whether extruded or coextruded. will instruct CBP to liquidate reimbursed. Excluded are metallized films and other unreviewed entries at the all-others rate These preliminary results of review finished films that have had at least one if there is no rate for the intermediate are issued and published in accordance of their surfaces modified by the company(ies) involved in the with sections 751(a)(1) and 777(i)(1) of application of a performance-enhancing transaction. For a full discussion of this the Act. resinous or inorganic layer of more than clarification, see Antidumping and 0.00001 inches thick. Imports of PET Countervailing Duty Proceedings: 9 See Implementation of the Findings of the WTO film are classifiable in the Harmonized Assessment of Antidumping Duties, 68 Panel in US—Zeroing (EC): Notice of Tariff Schedule of the United States FR 23954 (May 6, 2003). Determinations Under Section 129 of the Uruguay Round Agreements Act and Revocations and Partial (HTSUS) under item number Revocations of Certain Antidumping Duty Orders, 3920.62.00.90. HTSUS subheadings are 8 See 19 CFR 351.310. 72 FR 25261 (May 4, 2007). provided for convenience and customs

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purposes. The written description of the liquidate shipments of subject and Constitution Avenue NW., scope of the order is dispositive. merchandise produced and/or exported Washington, DC 20230, at a time and by SRF entered or withdrawn from location to be determined.5 Parties Methodology warehouse, for consumption from should confirm by telephone the date, The Department has conducted this January 1, 2011, through December 31, time, and location of the hearing. review in accordance with section 2011, at 2.84 percent ad valorem of the Unless the deadline is extended 751(a)(1)(A) of the Tariff Act of 1930, as entered value. pursuant to section 751(a)(3)(A) of the amended (the Act). For each of the The Department intends also to Act, the Department will issue the final subsidy programs found instruct CBP to collect cash deposits of results of this administrative review, countervailable, we preliminarily estimated CVDs at the rate of 2.84 including the results of our analysis of determine that there is a subsidy, i.e., a percent ad valorem of the entered value the issues raised by the parties in their government-provided financial on shipments of the subject comments, within 120 days after contribution that gives rise to a benefit merchandise produced and exported by issuance of these preliminary results. to the recipient, and that the subsidy is SRF, entered, or withdrawn from These preliminary results of review specific.1 For a full description of the warehouse, for consumption on or after are issued and published in accordance methodology underlying our the date of publication of the final with sections 751(a)(1) and 777(i)(1) of conclusions, see the Memorandum from results of this review. We intend to the Act and 19 CFR 351.221(b)(4). Christian Marsh, Deputy Assistant instruct CBP to continue to collect cash Dated: July 31, 2013. Secretary for Antidumping and deposits for non-reviewed companies at Paul Piquado, Countervailing Duty Operations to Paul the applicable company-specific CVD Piquado, Assistant Secretary for Import Assistant Secretary for Import rate for the most recent period or all- Administration. Administration, titled Decision others rate established in the [FR Doc. 2013–19094 Filed 8–6–13; 8:45 am] Memorandum for the Preliminary investigation. These deposit rates, when Results of Countervailing Duty (CVD) imposed, shall remain in effect until BILLING CODE 3510–DS–P Administrative Review: Polyethylene further notice. Terephthalate Film, Sheet and Strip DEPARTMENT OF COMMERCE from India (Preliminary Decision Disclosure and Public Hearing Memorandum), dated concurrently with The Department will disclose to International Trade Administration these results and hereby adopted by this parties to this proceeding the notice. calculations performed in reaching the [A–201–835] The Preliminary Decision preliminary results within five days of Lemon Juice From Mexico: Memorandum is a public document and the date of publication of these Termination of Suspended is on file electronically via Import preliminary results.2 Interested parties Investigation Administration’s Antidumping and may submit written comments (case Countervailing Duty Centralized briefs) within 30 days of publication of AGENCY: Import Administration, Electronic Service System (IA ACCESS). the preliminary results and rebuttal International Trade Administration, IA ACCESS is available to registered comments (rebuttal briefs) within five Department of Commerce. users at http://iaaccess.trade.gov and in days after the time limit for filing case SUMMARY: As a result of the the Central Records Unit, room 7046 of briefs.3 Pursuant to 19 CFR determination by the International the main Department of Commerce 351.309(d)(2), rebuttal briefs must be Trade Commission (the ‘‘ITC’’) that building. In addition, a complete limited to issues raised in the case termination of the suspended version of the Preliminary Decision briefs. Parties who submit arguments are antidumping duty investigation on Memorandum can be accessed directly requested to submit with the argument: lemon juice from Mexico would not be on the Internet at http://www.trade.gov/ (1) A statement of the issue; (2) a brief likely to lead to the continuation or ia. The signed Preliminary Decision summary of the argument; and (3) a recurrence of material injury to an Memorandum and the electronic table of authorities. All briefs must be industry in the United States, the versions of the Preliminary Decision filed electronically and received Department of Commerce (the Memorandum are identical in content. successfully through IA ACCESS. ‘‘Department’’) is terminating the Preliminary Results of Review Interested parties who wish to request suspended antidumping duty a hearing, or to participate if one is investigation. As a result, the As a result of this review, we requested, must do so within 30 days of preliminarily determine a net Department is also terminating the publication of these preliminary results Agreement Suspending the countervailable subsidy rate of 2.84 by submitting a written request to the percent ad valorem for SRF, for the Antidumping Investigation on Lemon Assistant Secretary for Import Juice from Mexico (the ‘‘Agreement’’). period January 1, 2011, through Administration, U.S. Department of December 31, 2011. DATES: Effective Date: September 21, Commerce, using Import 2012. Assessment and Cash Deposit Administration’s IA ACCESS system.4 Requirements Requests should contain the party’s FOR FURTHER INFORMATION CONTACT: name, address, and telephone number, Maureen Price or Sally C. Gannon, If these preliminary results are Bilateral Agreements Unit, Import adopted in our final results of this the number of participants, and a list of the issues to be discussed. If a request Administration, International Trade review, 15 days after publication of the Administration, U.S. Department of final results of this review the for a hearing is made, we will inform parties of the scheduled date for the Commerce, 14th Street and Constitution Department intends to instruct U.S. Avenue NW., Washington, DC 20230; Customs and Border Protection (CBP) to hearing which will be held at the U.S. Department of Commerce, 14th Street telephone: (202) 482–4271 or (202) 482– 0162, respectively. 1 See sections 771(5)(B) and (D) of the Act 2 SUPPLEMENTARY INFORMATION regarding financial contribution; section 771(5)(E) See 19 CFR 351.224(b). : of the Act regarding benefit; and section 771(5A) of 3 See 19 CFR 351.309(c)(1)(ii) and 351.309(d)(1). the Act regarding specificity. 4 See 19 CFR 351.310(c). 5 See 19 CFR 351.310.

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Background containers ready for sale to consumers, DEPARTMENT OF COMMERCE On August 1, 2012, pursuant to typically at a level of concentration of National Oceanic and Atmospheric section 751(c) of the Tariff Act of 1930, 48 GPL; and (2) beverage products such Administration as amended (‘‘the Act’’), the Department as lemonade that typically contain 20% or less lemon juice as an ingredient. initiated the first sunset review of the Proposed Information Collection; suspended antidumping duty Lemon juice is classifiable under Comment Request; Statement of investigation on lemon juice from subheadings 2009.39.6020, Financial Interests, Regional Fishery Mexico.1 On August 1, 2012, pursuant 2009.31.6020, 2009.31.4000, Management Councils to section 752 of the Act, the ITC 2009.31.6040, and 2009.39.6040 of the AGENCY: National Oceanic and instituted the first sunset review of the Harmonized Tariff Schedule of the Atmospheric Administration (NOAA). suspended antidumping duty United States (HTSUS). While HTSUS ACTION: Notice. investigation on lemon juice from subheadings are provided for Mexico.2 As a result of its review, on convenience and customs purposes, our SUMMARY: June 28, 2013, the Department found The Department of written description of the scope of this that termination of the suspended Commerce, as part of its continuing suspended investigation is dispositive. antidumping duty investigation on effort to reduce paperwork and respondent burden, invites the general lemon juice from Mexico would likely Termination lead to continuation or recurrence of public and other Federal agencies to take this opportunity to comment on dumping.3 The Department thus As a result of the determination by the proposed and/or continuing information notified the ITC of the magnitude of the ITC that termination of the suspended collections, as required by the margins of dumping rates likely to antidumping duty investigation would Paperwork Reduction Act of 1995. prevail if the suspended investigation not be likely to lead to continuation or were terminated. recurrence of material injury to an DATES: Written comments must be On August 1, 2013, the ITC published industry in the United States, pursuant submitted on or before October 7, 2013. its determination, pursuant to section to section 751(d)(2) of the Act, the ADDRESSES: Direct all written comments 751(c) of the Act, that termination of the Department is terminating the to Jennifer Jessup, Departmental antidumping duty suspended suspended antidumping duty Paperwork Clearance Officer, investigation on lemon juice from investigation on lemon juice from Department of Commerce, Room 6616, Mexico would not be likely to lead to Mexico. Pursuant to section 751(d)(2) of 14th and Constitution Avenue NW., the continuation or recurrence of the Act and 19 CFR 351.222(i)(2)(i), the Washington, DC 20230 (or via the Internet at [email protected]). material injury within a reasonably effective date of termination is 4 foreseeable time. September 21, 2012 (i.e., the fifth FOR FURTHER INFORMATION CONTACT: Therefore, pursuant to section anniversary of the effective date of Requests for additional information or 351.222(i)(1)(iii) of the Department’s publication in the Federal Register of copies of the information collection regulations, the Department is instrument and instructions should be the notice of suspension of publishing this notice of the termination directed to William Chappell, (301) investigation).5 Because the Department of the suspended antidumping duty 427–8505 or is terminating the suspended investigation on lemon juice from [email protected]. Mexico. antidumping duty investigation, the Agreement will also terminate, effective SUPPLEMENTARY INFORMATION: Scope of the Suspended Investigation September 21, 2012. I. Abstract The merchandise covered by the Administrative Protective Order This request is for revision and suspended investigation includes extension of a current information certain lemon juice for further This notice also serves as the only collection). manufacture, with or without addition reminder to parties subject to The Magnuson-Stevens Fishery of preservatives, sugar, or other administrative protective order (‘‘APO’’) Conservation and Management Act sweeteners, regardless of the GPL (grams of their responsibility concerning the (Magnuson Stevens Act) authorizes the per liter of citric acid) level of return/destruction or conversion to establishment of Regional Fishery concentration, brix level, brix/acid ratio, judicial protective order of proprietary Management Councils to exercise sound pulp content, clarity, grade, horticulture information disclosed under APO in judgment in the stewardship of fishery method (e.g., organic or not), processed accordance with 19 CFR 351.305(a)(3). resources through the preparation, form (e.g., frozen or not-from- Failure to comply is a violation of the monitoring, and revision of such fishery concentrate), FDA standard of identity, APO which may be subject to sanctions. management plans under circumstances the size of the container in which These five-year (sunset) reviews and (a) which will enable the States, the packed, or the method of packing. notice are in accordance with section fishing industry, consumers, Excluded from the scope are: (1) environmental organizations, and other lemon juice at any level of 75l(d)(2) the Act and published pursuant to section 777(i)(l) of the Act. interested persons to participate in the concentration packed in retail-sized development of such plans, and (b) Dated: August 1, 2013. which take into account the social and 1 Initiation of Five-Year (‘‘‘‘Sunset’’’) Review and Paul Piquado, economic needs of fishermen and Correction, 77 FR 45589 (August 1, 2012). 2 [Investigation Nos. 731–TA–1105–1106 Assistant Secretary for Import dependent communities. (Review)] Lemon Juice from Argentina and Mexico, Administration. Section 302(j) of the Magnuson- 77 FR 45653 (August 1, 2012). [FR Doc. 2013–19068 Filed 8–6–13; 8:45 am] Stevens Act requires that Council 3 Lemon Juice From Mexico: Final Results of Full BILLING CODE 3510–DS–P members appointed by the Secretary, Sunset Review of the Suspended Antidumping Scientific and Statistical Committee Duty Investigation, 78 FR 38944 (June 28, 2013). 4 [Investigation Nos. 731–TA–1105–1106 5 Suspension of Antidumping Duty Investigation: (SSC) members appointed by a Council (Review)] Lemon Juice from Argentina and Mexico, Lemon Juice From Mexico, 72 FR 53995 (September under Section 302(g)(1), or individuals 78 FR 46610 (August 1, 2013) 21, 2007). nominated by the Governor of a State for

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possible appointment as a Council Affected Public: Individuals or practical utility; (b) the accuracy of the member, disclose their financial interest households. agency’s estimate of the burden of the in any Council fishery. These interests Estimated Number of Respondents: proposed information collection; (c) include harvesting, processing, 330. ways to enhance the quality, utility, and lobbying, advocacy, or marketing Estimated Time per Response: 35 clarity of the information to be activity that is being, or will be, minutes. collected; and (d) ways to minimize the undertaken within any fishery over Estimated Total Annual Burden burden of the information collection on which the Council concerned has Hours: 193. respondents, including through the use jurisdiction, or with respect to an Estimated Total Annual Cost to of automated collection techniques or individual or organization with a Public: $128.70 in recordkeeping/ other forms of information technology. financial interest in such activity. The reporting costs. DATES: Consideration will be given to all authority to require this information and comments received by October 7, 2013 IV. Request for Comments reporting and filing requirements has ADDRESSES: You may submit comments, not changed. Comments are invited on: (a) Whether identified by docket number and title, The Secretary is required to submit an the proposed collection of information by any of the following methods: annual report to Congress on action is necessary for the proper performance • Federal eRulemaking Portal: http:// taken by the Secretary and the Councils of the functions of the agency, including www.regulations.gov. Follow the to implement the disclosure of financial whether the information shall have instructions for submitting comments. interest and recusal requirements, practical utility; (b) the accuracy of the • Mail: Federal Docket Management including identification of any conflict agency’s estimate of the burden System Office, 4800 Mark Center Drive, of interest problems with respect to the (including hours and cost) of the East Tower, Suite 02G09, Alexandria, Councils and SSCs and proposed collection of information; VA 22350–3100. recommendations for addressing any (c) ways to enhance the quality, Instructions: All submissions received such problems. utility, and clarity of the information to must include the agency name, docket The Act further provides that a be collected; and (d) ways to minimize number and title for this Federal member shall not vote on a Council the burden of the collection of Register document. The general policy decision that would have a significant information on respondents, including for comments and other submissions and predictable effect on a financial through the use of automated collection from members of the public is to make interest if there is a close causal link techniques or other forms of information these submissions available for public between the Council decision and an technology. viewing on the Internet at http:// expected and substantially Comments submitted in response to www.regulations.gov as they are disproportionate benefit to the financial this notice will be summarized and/or received without change, including any interest of the affected individual included in the request for OMB personal identifiers or contact relative to the financial interest of other approval of this information collection; information. participants in the same gear type or they also will become a matter of public FOR FURTHER INFORMATION CONTACT: To sector of the fishery. However, an record. request more information on this affected individual who is declared Dated: August 2, 2013. proposed information collection or to ineligible to vote on a Council action Gwellnar Banks, obtain a copy of the proposal and may participate in Council deliberations Management Analyst, Office of the Chief associated collection instruments, relating to the decision after notifying Information Officer. please write to the White House Communications Agency (WHCA/ the Council of his/her recusal and [FR Doc. 2013–19006 Filed 8–6–13; 8:45 am] WACC/ISD), ATTN: Chris Cothran, 2743 identifying the financial interest that BILLING CODE 3510–22–P would be affected. Defense Boulevard, SW Washington, DC Revision: NMFS is in the process of 20373–5815. Title; Associated Form; and OMB revising the form by adding clearer DEPARTMENT OF DEFENSE instructions, providing examples of Number: DefenseReady; OMB Control Number 0704–TBD. submissions, and updating the form to Office of the Secretary provide a more appropriate and Needs and Uses: The information intuitive format. [Docket ID: DoD–2013–OS–0170] collection requirement is necessary to obtain, track and record the personnel II. Method of Collection Proposed Collection; Comment security data, training information and Request Respondents submit paper forms. travel history within White House Military Office (WHMO) and White Seated Council members appointed by AGENCY: White House Communications House Communications Agency the Secretary, including the Tribal Agency (WHCA), DoD. Government appointee and SSC (WHCA). ACTION: Notice. Affected Public: DoD Contractors, members, must file a financial interest retired military members, and agency form within 45 days of taking office and In compliance with Section visitors. must provide updates of their 3506(c)(2)(A) of the Paperwork Annual Burden Hours: 38. statements at any time any such Reduction Act of 1995, the White House Number of Respondents: 150. financial interest is acquired, or Communications Agency (WHCA) Responses per Respondent: 1. substantially changed. announces a proposed public Average Burden Per Response: 15 III. Data information collection and seeks public minutes. comment on the provisions thereof. Frequency: On occasion. OMB Control Number: 0648–0192. Comments are invited on: (a) Whether SUPPLEMENTARY INFORMATION: Form Number: NOAA Form 88–195. the proposed collection of information Type of Review: Regular submission is necessary for the proper performance Summary of Information Collection (request for revision and extension of a of the functions of the agency, including Respondents are DoD Contractors, current information collection). whether the information shall have retired military members who have

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departed the agency, and agency Purpose of the Meeting included, as needed, to establish the visitors. The data collected is used for The purpose of the meeting is to appropriate historical context and to security background checks, training address and deliberate pending and new provide any necessary background records and also to encompass the issues before the Board. information. historical travel records of members of If the written statement is not the agency. This data collection is Agenda received at least five (5) business days essential in maintaining the integrity of Pursuant to 5 U.S.C. 552b, as prior to the meeting, the DFO may the agency’s personnel, training, and amended, and 41 CFR 102–3.140 choose to postpone consideration of the travel programs. through 102–3.165 and subject statement until the next open meeting. Dated: August 1, 2013. availability of space, the DHB meeting is The DFO will review all timely submissions with the DHB President Aaron Siegel, open to the public from 9:00 a.m. to 12:15 p.m. and 1:00 p.m. to 5:15 p.m. on and ensure they are provided to Alternate OSD Federal Register Liaison members of the DHB before the meeting Officer, Department of Defense. August 19, 2013. On August 19, 2013, that is subject to this notice. After [FR Doc. 2013–18991 Filed 8–6–13; 8:45 am] the DHB will receive briefings from the Department to include an update on the reviewing the written comments, the BILLING CODE 5001–06–P Department’s implementation of the President and the DFO may choose to recommendations from the Dover Port invite the submitter to orally present DEPARTMENT OF DEFENSE Mortuary Independent Review their issue during an open portion of Subcommittee report, and briefings on this meeting or at a future meeting. The Office of the Secretary the Integrated Mental Health Strategy DFO, in consultation with the DHB and the Dual Loyalties of Military President, may allot time for members of Defense Health Board; Notice of Medical Providers. The Board will vote the public to present their issues for Federal Advisory Committee Meeting on proposed recommendations review and discussion by the Defense regarding the implications of trends in Health Board. AGENCY: Department of Defense (DoD). overweight and obesity in America for Due to difficulties finalizing the ACTION: Meeting notice. the DoD and the report on the meeting agenda for the scheduled SUMMARY: Pursuant to the Federal Deployment Health Clinical Center meeting of August 19–20, 2013, of the Advisory Committee Act of 1972 (5 follow up review. Additionally, the Defense Health Board the requirements U.S.C., Appendix, as amended), the Board will receive briefings on the of 41 CFR 102–3.150(a) were not met. Government in the Sunshine Act of progress being made by the Accordingly, the Advisory Committee 1976 (5 U.S.C. 552b, as amended), and subcommittees on the sustainment and Management Officer for the Department 41 CFR § 102–3.150, a Defense Health advancement of amputee care, of Defense, pursuant to 41 CFR 102– Board (DHB) meeting is announced. deployment pulmonary health and the 3.150(b), waives the 15-calendar day dual loyalties of military medical notification requirement. DATES: providers. Dated: August 1, 2013. August 19, 2013 Public’s Accessibility to the Meeting Aaron Siegel, 8:00 a.m.–8:45 a.m. (Administrative Pursuant to 5 U.S.C. 552b, as Alternate OSD Federal Register Liaison Officer, Department of Defense. Working Meeting) amended, and 41 CFR 102–3.140 9:00 a.m.–12:15 p.m. (Open Session) through 102–3.165 and subject to [FR Doc. 2013–18978 Filed 8–6–13; 8:45 am] 12:15 p.m.–1:00 p.m. (Administrative BILLING CODE 5001–06–P Working Meeting) availability of space, this meeting is 1:00 p.m.–5:15 p.m. (Open Session) open to the public. Seating is limited and is on a first-come basis. August 20, 2013 DEPARTMENT OF DEFENSE Special Accommodations 8:00 a.m.–1:00 p.m. (Administrative Department of the Air Force Working Meeting) Individuals requiring special accommodations to access the public ADDRESSES: Marriott Annapolis Extension of Public Comment Period meeting should contact Ms. Kendal Waterfront, Chesapeake Ballroom North for the Environmental Impact Brown at least five (5) business days & Center, 80 Compromise Street, Statement on the Proposed Relocation prior to the meeting so that appropriate Annapolis, Maryland 21401. of 18th Aggressor Squadron to Joint arrangements can be made. FOR FURTHER INFORMATION CONTACT: The Base Elmendorf-Richardson, Alaska Director of the Defense Health Board is Written Statements ACTION: Notice. Ms. Christine Bader, 7700 Arlington Any member of the public wishing to Boulevard, Suite 5101, Falls Church, provide comments to the DHB may do SUMMARY: The U.S. Air Force is issuing Virginia 22042, (703) 681–6653, Fax: so in accordance with 41 CFR 102– this notice to advise the public of an (703) 681–3317, 3.105(j) and 102–3.140 and section extension to the public comment period [email protected]. For 10(a)(3) of the Federal Advisory on the environmental impact statement meeting information, please contact Ms. Committee Act, and the procedures on the proposed relocation of the 18th Kendal Brown, 7700 Arlington described in this notice. Aggressor Squadron to Joint Base Boulevard, Suite 5101, Falls Church, Individuals desiring to provide Elmendord-Richardson, Alaska. The Virginia 22042, comments to the DHB may do so by initial Notice of Availability published [email protected], (703) submitting a written statement to the in the Federal Register on May 31, 2013 681–6670, Fax: (703) 681–3317. DHB Designated Federal Officer (DFO) (78 FR 32645), and established a public SUPPLEMENTARY INFORMATION: (see FOR FURTHER INFORMATION CONTACT). comment period from May 31 through Additional information, including the Written statements should address the August 2, 2013. The Air Force has agenda and electronic registration, is following details: the issue, discussion, extended the deadline for submitting available at the DHB Web site, http:// and a recommended course of action. public comments to August 30, 2013. www.health.mil/dhb/. Supporting documentation may also be All substantive comments received by

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August 30, 2013 will be addressed in (c) Whether you submit your feature at: www.federalregister.gov. the Public Comment Section of the Final application by mail (through the U.S. Specifically, through the advanced EIS. Postal Service or a commercial carrier) search feature at this site, you can limit FOR FURTHER INFORMATION CONTACT: or deliver your application by hand or your search to documents published by Please direct any written comments or by courier service, you must mail or the Department. requests for information to Mr. Allen deliver three copies of your application, Authority: 20 U.S.C. 9212 Richmond, AFCEC/CZN, 2261 Hughes on or before the deadline date, to the Ave, Ste 155, Lackland AFB, TX 78236– following address: NRS Assessment Dated: August 1, 2013. 9853. Review, c/o American Institute for Johan Uvin, Research, 1000 Thomas Jefferson Street Deputy Assistant Secretary for Policy and Henry Williams Jr, NW., Washington, DC 20007. Strategic Initiatives, Delegated Authority to DAF, Acting Air Force Federal Register (d) If you submit your application by Perform the Functions and Duties of the Liaison Officer. Assistant Secretary for Vocational and Adult mail or commercial carrier, you must Education. [FR Doc. 2013–19048 Filed 8–6–13; 8:45 am] show proof of mailing consisting of one BILLING CODE 5001–10–P of the following: [FR Doc. 2013–19070 Filed 8–6–13; 8:45 am] (1) A legibly dated U.S. Postal Service BILLING CODE 4000–01–P postmark. DEPARTMENT OF EDUCATION (2) A legible mail receipt with the DEPARTMENT OF EDUCATION date of mailing stamped by the U.S. Notice Inviting Publishers To Submit Postal Service. Tests for a Determination of Suitability Advisory Committee on Student (3) A dated shipping label, invoice, or Financial Assistance; Meeting for Use in the National Reporting receipt from a commercial carrier. System for Adult Education (4) Any other proof of mailing AGENCY: Advisory Committee on AGENCY: Office of Vocational and Adult acceptable to the Secretary of Education. Student Financial Assistance, Education, Department of Education. (e) If you mail your application Education. ACTION: Notice. through the U.S. Postal Service, we do ACTION: Notice of open teleconference not accept either of the following as meeting. DATES: Deadline for transmittal of proof of mailing: applications: October 1, 2013. (1) A private metered postmark. SUMMARY: This notice sets forth the SUMMARY: The Secretary of Education (1) (2) A mail receipt that is not dated by schedule and proposed agenda of a invites publishers to submit tests for the U.S. Postal Service. forthcoming open teleconference review and approval for use in the (f) If your application is postmarked meeting of the Advisory Committee on National Reporting System for Adult after the application deadline date, we Student Financial Assistance. This Education (NRS); and (2) announces the will not consider your application. notice also describes the functions of the Advisory Committee. Notice of this date by which publishers must submit Note: The U.S. Postal Service does not these tests. uniformly provide a dated postmark. Before meeting is required under Section 10(a)(2) of the Federal Advisory FOR FURTHER INFORMATION CONTACT: relying on this method, you should check Committee Act. This document is Michelle Meier, U.S. Department of with your local post office. intended to notify the general public of Education, 400 Maryland Avenue SW., (g) If you submit your application by their opportunity to attend. Room 11161, Potomac Center Plaza, hand delivery, you (or a courier service) Date and Time: Thursday, August 29, Washington, DC 20202–7240. must deliver three copies of the 2013, beginning at 4:00 p.m. and ending Telephone: (202) 245–7890 or by email: application by hand, on or before at approximately 4:30 p.m. (EDT). [email protected]. 4:30:00 p.m., Washington, DC time, on If you use a telecommunications the application deadline date. ADDRESSES: Office of the Advisory device for the deaf (TDD) or a text Accessible Format: Individuals with Committee on Student Financial telephone (TTY), call the Federal Relay disabilities can obtain this document in Assistance, Capitol Place, 80 F Street Service (FRS), toll free, at 1–800–877– an accessible format (e.g., braille, large NW., Room 412, Washington DC 20202– 8339. print, audiotape, or compact disc) on 7582. FOR FURTHER INFORMATION CONTACT: Dr. SUPPLEMENTARY INFORMATION: The request to the contact person listed in Department’s regulations for Measuring this notice. William J. Goggin, Executive Director, Educational Gain in the National Electronic Access to This Document: Advisory Committee on Student Reporting System for Adult Education, The official version of this document is Financial Assistance, Capitol Place, 80 F 34 CFR part 462 (NRS regulations), the document published in the Federal Street NW., Suite 413, Washington DC include the procedures for determining Register. Free Internet access to the 20202–7582, (202) 219–2099. the suitability of tests for use in the official edition of the Federal Register SUPPLEMENTARY INFORMATION: The NRS. and the Code of Federal Regulations is Advisory Committee on Student Criteria the Secretary uses: In order available via the Federal Digital System Financial Assistance is established for the Secretary to consider a test at: www.gpo.gov/fdsys. At this site you under Section 491 of the Higher suitable for use in the NRS, the test can view this document, as well as all Education Act of 1965 as amended by must meet the criteria and requirements other documents of this Department Public Law 100–50 (20 U.S.C. 1098). established in § 462.13. published in the Federal Register, in The Advisory Committee serves as an Submission Requirements: text or Adobe Portable Document independent source of advice and (a) In preparing your application, you Format (PDF). To use PDF you must counsel to the Congress and the must comply with the requirements in have Adobe Acrobat Reader, which is Secretary of Education on student § 462.11. available free at the site. financial aid policy. Since its inception, (b) In accordance with § 462.10, the You may also access documents of the the congressional mandate requires the deadline for transmittal of applications Department published in the Federal Advisory Committee to conduct is October 1. Register by using the articlesearch objective, nonpartisan, and independent

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analyses on important aspects of the through Friday, except Federal holidays. its environmental assessment (EA) and student assistance programs under Title Information regarding the Advisory place it into the Commission’s public IV of the Higher Education Act. In Committee is available on the record (eLibrary) for this proceeding; or addition, Congress expanded the Committee’s Web site, www.ed.gov/ issue a Notice of Schedule for Advisory Committee’s mission in the ACSFA. Environmental Review. If a Notice of Higher Education Opportunity Act of Dated: August 1, 2013. Schedule for Environmental Review is 2008 to include several important areas: issued, it will indicate, among other William J. Goggin, access, Title IV modernization, early milestones, the anticipated date for the information and needs assessment and Executive Director, Advisory Committee on Commission staff’s issuance of the final Student Financial Assistance. review and analysis of regulations. environmental impact statement (FEIS) Specifically, the Advisory Committee is [FR Doc. 2013–19085 Filed 8–6–13; 8:45 am] or EA for this proposal. The filing of the to review, monitor and evaluate the BILLING CODE 4000–01–P EA in the Commission’s public record Department of Education’s progress in for this proceeding or the issuance of a these areas and report recommended Notice of Schedule for Environmental improvements to Congress and the DEPARTMENT OF ENERGY Review will serve to notify federal and Secretary. state agencies of the timing for the The Advisory Committee has Federal Energy Regulatory completion of all necessary reviews, and scheduled this teleconference for the Commission the subsequent need to complete all sole purpose of electing an ACSFA [Docket No. CP13–525–000] federal authorizations within 90 days of member to serve as chair and a member the date of issuance of the Commission to serve as vice-chair for one-year Tallgrass Interstate Gas Transmission, staff’s FEIS or EA. beginning October 1, 2013. LLC; Notice of Application There are two ways to become Space at the F Street meeting site and involved in the Commission’s review of ‘‘dial-in’’ line for the teleconference Take notice that on July 22, 2013, this project. First, any person wishing to meeting is limited and you are Tallgrass Interstate Gas Transmission, obtain legal status by becoming a party encouraged to register early if you plan LLC (Tallgrass) 370 Van Gordon Street, to the proceedings for this project to attend. You may register by sending Lakewood, Colorado, filed in the above should, on or before the comment date an email to the following email address: referenced docket an application stated below, file with the Federal [email protected]. Please pursuant to section 7(c) of the Natural Energy Regulatory Commission, 888 include your name, title, affiliation, Gas Act (NGA) and Part 157 of the First Street, NE., Washington, DC 20426, complete address (including internet Commission’s regulations, requesting a motion to intervene in accordance and email, if available), and telephone authorization to operate an existing with the requirements of the and fax numbers. If you are unable to delivery point connecting Tallgrass to Commission’s Rules of Practice and register electronically, you may fax your Garden Fresh Vegetables (GFV), an end- Procedure (18 CFR 385.214 or 385.211) registration information to the Advisory user located in Holt County, Nebraska. and the Regulations under the NGA (18 Committee staff office at (202) 219– GFV presently receives its existing gas CFR 157.10). A person obtaining party 3032. You may also contact the service from SourceGas Distribution status will be placed on the service list Advisory Committee staff directly at LLC, a local distribution company, all as maintained by the Secretary of the (202) 219–2099. The registration more fully set forth in the application Commission and will receive copies of deadline is Monday, August 26, 2013. which is on file with the Commission all documents filed by the applicant and Individuals who will need and open to public inspection. The by all other parties. A party must submit accommodations for a disability in order filing may also be viewed on the web at 7 copies of filings made with the to attend the teleconference meeting http://www.ferc.gov using the Commission and must mail a copy to (i.e., interpreting services, assistive ‘‘eLibrary’’ link. Enter the docket the applicant and to every other party in listening devices, and/or materials in number excluding the last three digits in the proceeding. Only parties to the alternative format) should notify the the docket number field to access the proceeding can ask for court review of Advisory Committee no later than document. For assistance, please contact Commission orders in the proceeding. Wednesday, August 21, 2013 by FERC Online Support at However, a person does not have to contacting Ms. Tracy Jones at (202) 219– [email protected] or toll intervene in order to have comments 2099 or via email at free at (866) 208–3676, or TTY, contact considered. The second way to [email protected]. We will (202) 502–8659. participate is by filing with the attempt to meet requests after this date, Tallgrass requests authorization to Secretary of the Commission, as soon as but cannot guarantee availability of the place into operation the previously possible, an original and two copies of requested accommodation. The constructed delivery point, which comments in support of or in opposition teleconference site is accessible to cannot be operated until they get to this project. The Commission will individuals with disabilities. approval under the above referenced consider these comments in Individuals who use a docket number. The total cost to determining the appropriate action to be telecommunications device for the deaf construct the subject delivery point was taken, but the filing of a comment alone (TTY) may call the Federal Information $111,983. will not serve to make the filer a party Relay Service (FRS) toll free at 1–800– Any questions concerning this to the proceeding. The Commission’s 877–8339. application may be directed to Skip rules require that persons filing Records are kept for Advisory George, Manager of Regulatory, comments in opposition to the project Committee proceedings, and are Tallgrass Interstate Gas Transmission, provide copies of their protests only to available for inspection at the Office of LLC, 370 Van Gordon Street, Lakewood, the party or parties directly involved in the Advisory Committee on Student Colorado 80228, at (303) 763–3251. the protest. Financial Assistance, Capitol Place, 80 F Pursuant to section 157.9 of the Persons who wish to comment only Street NW., Suite 413, Washington, DC Commission’s rules, 18 CFR 157.9, on the environmental review of this from the hours of 9:00 a.m. to 5:30 p.m. within 90 days of this Notice the project should submit an original and Eastern Standard Time, Monday Commission staff will either: complete two copies of their comments to the

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Secretary of the Commission. and operate its Mobile South III Commission’s Rules of Practice and Environmental commentors will be Expansion Project (project), an Procedure (18 CFR 385.214 or 385.211) placed on the Commission’s expansion of the capacity on Transco’s and the Regulations under the NGA (18 environmental mailing list, will receive existing Mobile Bay Lateral, under CFR 157.10). A person obtaining party copies of the environmental documents, which Transco will provide 225,000 status will be placed on the service list and will be notified of meetings dekatherms of incremental southbound maintained by the Secretary of the associated with the Commission’s firm transportation service. The project Commission and will receive copies of environmental review process. will include the addition of 20,500 all documents filed by the applicant and Environmental commentors will not be horsepower of compression, station by all other parties. A party must submit required to serve copies of filed piping, and facilities appurtenant 14 copies of filings made with the documents on all other parties. thereto at Transco’s Compressor Station Commission and must mail a copy to However, the non-party commentors 85 located at the interconnection of the the applicant and to every other party in will not receive copies of all documents Mobile Bay Lateral and Transco’s main the proceeding. Only parties to the filed by other parties or issued by the line in Choctaw County, Alabama, all as proceeding can ask for court review of Commission (except for the mailing of more fully set forth in the application Commission orders in the proceeding. environmental documents issued by the which is on file with the Commission However, a person does not have to and open to public inspection. This Commission) and will not have the right intervene in order to have comments filing may also be viewed on the to seek court review of the considered. The second way to Commission’s Web site at http:// Commission’s final order. participate is by filing with the www.ferc.gov using the ‘‘eLibrary’’ link. The Commission strongly encourages Secretary of the Commission, as soon as Enter the docket number, excluding the electronic filings of comments, protests possible, an original and two copies of last three digits, in the docket number and interventions in lieu of paper using comments in support of or in opposition field to access the document. For the ‘‘eFiling’’ link at http:// to this project. The Commission will assistance, call (866) 208–3676 or TTY, www.ferc.gov. Persons unable to file consider these comments in electronically should submit an original (202) 502–8659. Any questions regarding this determining the appropriate action to be and 5 copies of the protest or taken, but the filing of a comment alone intervention to the Federal Energy application should be directed to Scott Turkington, Director, Rates & will not serve to make the filer a party Regulatory Commission, 888 First to the proceeding. The Commission’s Street, NE., Washington, DC 20426. Regulatory, Transcontinental Gas Pipeline Company, LLC, Post Office Box rules require that persons filing This filing is accessible on-line at comments in opposition to the project http://www.ferc.gov, using the 1396, Houston, Texas, 77251–1396, or by calling (713) 215–3391 or provide copies of their protests only to ‘‘eLibrary’’ link and is available for the party or parties directly involved in review in the Commission’s Public [email protected]. Pursuant to Section 157.9 of the the protest. Reference Room in Washington, DC. Commission’s rules, 18 CFR 157.9, There is an ‘‘eSubscription’’ link on the Persons who wish to comment only within 90 days of this Notice the Web site that enables subscribers to on the environmental review of this Commission staff will either: Complete receive email notification when a project should submit an original and its environmental assessment (EA) and document is added to a subscribed two copies of their comments to the place it into the Commission’s public docket(s). For assistance with any FERC Secretary of the Commission. record (eLibrary) for this proceeding, or Online service, please email Environmental commenters will be issue a Notice of Schedule for [email protected], or call placed on the Commission’s Environmental Review. If a Notice of (866) 208–3676 (toll free). For TTY, call environmental mailing list, will receive Schedule for Environmental Review is copies of the environmental documents, (202) 502–8659. issued, it will indicate, among other Comment Date: August 22, 2013. and will be notified of meetings milestones, the anticipated date for the associated with the Commission’s Dated: August 1, 2013. Commission staff’s issuance of the final environmental review process. Kimberly D. Bose, environmental impact statement (FEIS) Environmental commenters will not be Secretary. or EA for this proposal. The filing of the required to serve copies of filed [FR Doc. 2013–19031 Filed 8–6–13; 8:45 am] EA in the Commission’s public record documents on all other parties. BILLING CODE 6717–01–P for this proceeding or the issuance of a However, the non-party commenters Notice of Schedule for Environmental will not receive copies of all documents Review will serve to notify federal and filed by other parties or issued by the DEPARTMENT OF ENERGY state agencies of the timing for the Commission (except for the mailing of completion of all necessary reviews, and environmental documents issued by the Federal Energy Regulatory the subsequent need to complete all Commission) and will not have the right Commission federal authorizations within 90 days of to seek court review of the the date of issuance of the Commission [Docket No. CP13–523–000] Commission’s final order. staff’s FEIS or EA. There are two ways to become The Commission strongly encourages Transcontinental Gas Pipe Line electronic filings of comments, protests Company, LLC; Notice of Application involved in the Commission’s review of this project. First, any person wishing to and interventions in lieu of paper using Take notice that on July 18, 2013, obtain legal status by becoming a party the ‘‘eFiling’’ link at http:// Transcontinental Gas Pipe Line to the proceedings for this project www.ferc.gov. Persons unable to file Company, LLC (Transco), filed in should, on or before the comment date electronically should submit an original Docket No. CP13–523–000, an stated below, file with the Federal and 5 copies of the protest or application pursuant to section 7(c) of Energy Regulatory Commission, 888 intervention to the Federal Energy the Natural Gas Act (NGA) and Part 157 First Street NE., Washington, DC 20426, Regulatory Commission, 888 First Street of the Commission’s regulations, a motion to intervene in accordance NE., Washington, DC 20426. requesting authorization to construct with the requirements of the Comment Date: August 22, 2013.

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Dated: August 1, 2013. [email protected] or toll varies between 9,000 and 18,000 Kimberly D. Bose, free at 1–866–208–3676, or for TTY, kilowatt-hours. Secretary. (202) 502–8659. Although the All of the existing project facilities are [FR Doc. 2013–19030 Filed 8–6–13; 8:45 am] Commission strongly encourages owned by the applicant. The applicant BILLING CODE 6717–01–P electronic filing, documents may also be proposes no new facilities or changes to paper-filed. To paper-file, mail an existing project operations. original and five copies to: Kimberly D. m. Due to the projects works already DEPARTMENT OF ENERGY Bose, Secretary, Federal Energy existing and the applicant’s close Regulatory Commission, 888 First Street coordination with federal and state Federal Energy Regulatory NE., Washington, DC 20426. agencies during the preparation of the Commission The Commission’s Rules of Practice application, we intend to waive scoping. require all intervenors filing documents [Project No. 14345–001] Based on a review of the application with the Commission to serve a copy of and resource agency consultation Rock River Beach, Inc.; Notice of that document on each person on the letters, Commission staff intends to Application Accepted for Filing With official service list for the project. prepare a single environmental the Commission; Intent To Waive Further, if an intervenor files comments assessment (EA). Commission staff has Scoping; Soliciting Motions To or documents with the Commission determined that the issues that need to Intervene and Protests; Ready for relating to the merits of an issue that be addressed in its EA have been Environmental Analysis; and Soliciting may affect the responsibilities of a adequately identified during the pre- Comments, Terms and Conditions, particular resource agency, they must filing period, which included a public Recommendations, and Prescriptions also serve a copy of the document on meeting and site visit, and no new that resource agency. issues are likely to be identified through Take notice that the following k. This application has been accepted additional scoping. The EA will hydroelectric application has been filed for filing and is now ready for consider assessing the potential effects environmental analysis. with the Commission and is available of project operation on geology and l. The Rock River Beach Project for public inspection. soils, aquatic, terrestrial, threatened and a. Type of Application: Original consists of the following existing facilities: (1) A 33.6-foot-long by 5.5- endangered species, recreation and land Minor License. use, aesthetic, and cultural and historic b. Project No.: 14345–001. foot-high, L-shaped gravity dam with a resources. c. Date filed: November 23, 2012. crest elevation of 606.95 feet North d. Applicant: Rock River Beach, Inc. American Vertical Datum of 1988 n. A copy of the application is e. Name of Project: Rock River Beach (NAVD 88) that impounds a 5-acre available for review at the Commission Hydroelectric Project reservoir with a total storage capacity of in the Public Reference Room or may be f. Location: On the Rock River, in the 25 acre-feet; (2) an 8-foot-wide spillway viewed on the Commission’s Web site at Town of Onota, Alger County, containing two steel sluice gates, a 24- http://www.ferc.gov using the Michigan. The project would not inch-high bottom gate that remains fixed ‘‘eLibrary’’ link. Enter the docket occupy any federal lands. in place and a 36-inch-high slide gate number excluding the last three digits in g. Filed Pursuant to: Federal Power that is raised and lowered manually; (3) the docket number field to access the Act, 16 U.S.C. 791(a)–825(r). a 30-foot-wide by 50-foot-long power document. For assistance, contact FERC h. Applicant Contact: Mary C. Edgar, canal; (4) an 18-foot by 24-foot wood- Online Support. A copy is also available 2617 Rockwood, East Lansing, MI framed powerhouse housing a 3- for inspection and reproduction at the 48823; or by telephone at (906) 892– kilowatt (kW) generating unit run by a address in item h above. 8112. water wheel and a 5-kW generating unit Register online at http:// i. FERC Contact: Aaron Liberty at run by a 24-inch vertical-shaft propeller www.ferc.gov/docs-filing/ (202) 502–6862 or by email at Aaron. turbine for a total installed capacity of esubscription.asp to be notified via [email protected]. 8 kW; and (5) two, 220-volt, 0.5-mile- email of new filings and issuances j. Deadline for filing motions to long transmission lines. The related to this or other pending projects. intervene and protests, requests for powerhouse also contains a 6-kW For assistance, contact FERC Online cooperating agency status, comments, antique Edison generator that operates Support. terms and conditions, via the water wheel and is operated o. Any qualified applicant desiring to recommendations, and prescriptions: 60 once a year. file a competing application must days from the issuance date of this The applicant operates the project in submit to the Commission, on or before notice; reply comments are due 105 a run-of-river mode (i.e., at any point in the specified intervention deadline date, days from the issuance date of this time, the combined outflow from the a competing development application, notice. project’s dam and powerhouse or a notice of intent to file such an All documents may be filed approximates all inflows to the project’s application. Submission of a timely electronically via the Internet. See 18 reservoir). The project operates from notice of intent allows an interested CFR 385.2001(a)(1)(iii) and the June 20 through September 15, and person to file the competing instructions on the Commission’s Web October 15 through November 15. At all development application no later than site http://www.ferc.gov/docs-filing/ other times, the reservoir is drawn down 120 days after the specified intervention efiling.asp. Commenters can submit approximately 4 feet with the fixed deadline date. Applications for brief comments up to 6,000 characters, sluice gate maintaining an 18 to 24-inch preliminary permits will not be without prior registration, using the head to prevent the upstream migration accepted in response to this notice. eComment system at http:// of sea lamprey from Lake Superior. A notice of intent must specify the www.ferc.gov/docs-filing/ Diversion of river flow through the 50- exact name, business address, and ecomment.asp. You must include your foot-long power canal and to the telephone number of the prospective name and contact information at the end powerhouse creates a 100-foot-long applicant, and must include an of your comments. For assistance, bypassed reach in the Rock River. unequivocal statement of intent to please contact FERC Online Support at Average annual generation at the project submit a development application. A

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notice of intent must be served on the Dated: July 31, 2013. ENVIRONMENTAL PROTECTION applicant(s) named in this public notice. Kimberly D. Bose, AGENCY Anyone may submit comments, a Secretary. protest, or a motion to intervene in [FR Doc. 2013–18994 Filed 8–6–13; 8:45 am] [FRL– 9843–5; Docket ID No. EPA–HQ– ORD–2011–0805] accordance with the requirements of BILLING CODE 6717–01–P Rules of Practice and Procedure, 18 CFR Update to An Inventory of Sources and 385.210, .211, and .214. In determining Environmental Releases of Dioxin-Like DEPARTMENT OF ENERGY the appropriate action to take, the Compounds in the United States for Commission will consider all protests or Federal Energy Regulatory the Years 1987, 1995, and 2000 other comments filed, but only those Commission who file a motion to intervene in AGENCY: Environmental Protection accordance with the Commission’s Notice of Commissioner and Staff Agency (EPA). Rules may become a party to the Attendance at North American Electric ACTION: Notice of public comment proceeding. Any comments, protests, or Reliability Corporation Meetings period and letter peer-review. motions to intervene must be received SUMMARY: EPA is announcing a 30-day on or before the specified comment date The Federal Energy Regulatory public comment period for the draft Commission (Commission) hereby gives for the particular application. document entitled, Update to An notice that members of the Commission All filings must: (1) Bear in all capital Inventory of Sources and Environmental and/or Commission staff may attend the letters the title ‘‘PROTEST’’, ‘‘MOTION Releases of Dioxin-Like Compounds in following meetings: TO INTERVENE’’, ‘‘NOTICE OF the United States for the Years 1987, INTENT TO FILE COMPETING North American Electric Reliability 1995, and 2000, (EPA/600/R–11/005A). APPLICATION,’’ ‘‘COMPETING Corporation Member Representatives EPA also is announcing that Versar, APPLICATION,’’ ‘‘COMMENTS,’’ Committee and Board of Trustees Meetings Inc., an EPA contractor for external Board of Trustees Corporate Governance and ‘‘REPLY COMMENTS,’’ Human Resources Committee, Compliance scientific peer review, will select a ‘‘RECOMMENDATIONS,’’ ‘‘TERMS Committee, Finance and Audit Committee, group of experts to conduct a letter peer- AND CONDITIONS,’’ or and Standards Oversight and Technology review of the draft document. The ‘‘PRESCRIPTIONS;’’ (2) set forth in the Committee Meetings document was prepared by the National heading the name of the applicant and Center for Environmental Assessment the project number of the application to Fairmont The Queen Elizabeth, 900 (NCEA) within EPA’s Office of Research which the filing responds; (3) furnish Rene´-Le´vesque Blvd. West, Montreal, and Development. the name, address, and telephone QC H3B 4A5, Canada. In November 2006, EPA released the number of the person protesting or August 14 (7:30 a.m.—5:30 p.m.) and report: An Inventory of Sources and intervening; and (4) otherwise comply August 15 (8:00 a.m.—1:00 p.m.), 2013 Environmental Releases of Dioxin-Like with the requirements of 18 CFR Compounds in the United States for the 385.2001 through 385.2005. All Further information regarding these Years 1987, 1995, and 2000, (EPA/600/ comments, recommendations, terms and meetings may be found at: http:// P–03/002F). That report presented an conditions or prescriptions must set www.nerc.com/Pages/Calendar.aspx. evaluation of sources and emissions of forth their evidentiary basis and The discussions at the meetings, dioxins, dibenzofurans, and coplanar otherwise comply with the requirements which are open to the public, may polychlorinated biphenyls to the air, of 18 CFR 4.34(b). Agencies may obtain address matters at issue in the following land, and water of the United States. copies of the application directly from Commission proceedings: The inventory suggested that there was the applicant. A copy of any protest or a significant reduction in environmental Docket No. RC11–5, North American motion to intervene must be served releases of dioxin-like compounds from Electric Reliability Corporation upon each representative of the regulated industrial sources between the applicant specified in the particular Docket No. RC13–4, North American years 1987 and 2000, and that the open application. A copy of all other filings Electric Reliability Corporation burning of residential refuse in backyard burn barrels was the largest source in in reference to this application must be Docket No. RR13–3, North American 2000 that could be reliably quantified. accompanied by proof of service on all Electric Reliability Corporation This revised draft is an update to the persons listed in the service list Docket No. RR13–6, North American 2006 report and reflects the additional prepared by the Commission in this Electric Reliability Corporation consideration of pre-2006 peer review. proceeding, in accordance with 18 CFR This update does not expand the scope 4.34(b) and 385.2010. Docket No. RR13–7, North American Electric Reliability Corporation of the document beyond the three p. Procedural schedule: The reference years covered in the 2006 Docket No. RD13–9, North American application will be processed according document or earlier drafts: 1987, 1995, Electric Reliability Corporation to the following procedural schedule. and 2000. Changes in the updated report Revisions to the schedule may be made Docket No. RD13–10, North American reflect the addition of previously as appropriate. Electric Reliability Corporation unquantified sources and adjustments to For further information, please emission factors, for example those used Milestone Target date contact Jonathan First, 202–502–8529, for municipal and medical waste or [email protected]. incinerators. The largest source added to Comments, recommenda- September the inventory was emissions to air from tions, and terms and 2013. Dated: July 31, 2013. forest fires, a source previously conditions due. Kimberly D. Bose, classified as preliminary and not Reply comments due ...... November 2013. Secretary. included in the quantitative inventory. Notice of the availability of February 2014. [FR Doc. 2013–18995 Filed 8–6–13; 8:45 am] the EA. The updated inventory lists the top BILLING CODE 6717–01–P three air sources in the year 2000 as

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forest fires, backyard barrel burning of an overview of sources and that year. The top three air sources in refuse, and medical waste incinerators. environmental releases of dioxin-like 2000 were forest fires (730 g WHO98 EPA intends to forward the public compounds in the United States. The TEQDF), backyard barrel burning of comments that are submitted in major identified sources of refuse (600 g WHO98 TEQDF), and accordance with this notice to Versar to environmental releases of dioxin-like medical waste incinerators (400 g distribute to the external peer-reviewers compounds are grouped into six broad WHO98 TEQDF). Other new sources for their consideration during the letter categories: combustion sources, metals added to the present document were peer-review. When finalizing the draft smelting, refining and processing secondary zinc smelters, glass document, EPA intends to consider any sources, chemical manufacturing manufacturers, lime kilns, agricultural public comments received in sources, natural sources, and burning, outdoor wood combustors, accordance with this notice. EPA is environmental reservoirs. Estimates of aluminum foundries, copper foundries, releasing this draft assessment for the annual releases to land, air, and water and septic systems. purposes of public comment and peer are presented for each source category II. How to Submit Technical Comments review. This draft assessment is not and summarized for reference years to the Docket at www.regulations.gov final as described in EPA’s information 1987, 1995, and 2000. The quantitative quality guidelines, and it does not results are expressed in terms of the Submit your comments, identified by represent and should not be construed toxicity equivalent (TEQ) of the mixture Docket ID No. EPA–HQ–ORD 2011– 0805, by one of the following methods: to represent Agency policy or views. of polychlorinated dibenzo-p-dioxin • The draft document is available via (CDD) and polychlorinated www.regulations.gov: Follow the the Internet on the NCEA home page dibenzofuran (CDF) compounds present on-line instructions for submitting under the Recent Additions and the in environmental releases using a comments; • Email: [email protected]; Data and Publications menus at procedure sanctioned by the World • www.epa.gov/ncea. Fax: 202–566–9744; Health Organization (WHO) in 1998. • Mail: Office of Environmental DATES: The 30-day public comment This TEQ procedure translates the Information (OEI) Docket (Mail Code: period begins August 7, 2013, and ends complex mixture of CDDs and CDFs 28221T), U.S. Environmental Protection September 6, 2013. Technical comments characteristic of environmental releases Agency, 1200 Pennsylvania Avenue should be in writing and must be into an equivalent toxicity NW, Washington, DC 20460. The received by EPA by September 6, 2013. concentration of 2,3,7,8- telephone number is 202–566–1752. If ADDRESSES: The draft document, Update tetrachlorodibenzo-p-dioxin (2,3,7,8- you provide comments by mail, please to An Inventory of Sources and TCDD), the most toxic member of this submit one unbound original with pages Environmental Releases of Dioxin-Like class of compounds. The total releases numbered consecutively and three Compounds in the United States for the under the national inventory for 1987 in copies of the comments. For Years 1987, 1995, and 2000, is available g WHO98 TEQDF (grams of dioxin toxic attachments, provide an index, number primarily via the Internet on the equivalents (TEQs), to include only pages consecutively with the comments, National Center for Environmental dioxin and furan congeners (not dioxin- and submit an unbound original and Assessment’s home page under the like PCB congeners), and determined three copies; or Recent Additions and the Data and using the 1998 World Health • Hand Delivery: The OEI Docket is Publications menus at www.epa.gov/ Organization’s Toxic Equivalency located in the EPA Headquarters Docket ncea. A limited number of paper copies Factors (TEFs)) were 15,000 to air, 2,400 Center, EPA West Building, Room 3334, are available from the Information to land, 360 to water, and 36 to 1301 Constitution Avenue NW, Management Team, NCEA; telephone: products. For 1995, the releases in g Washington, DC. The EPA Docket 703–347–8561; facsimile: 703–347– WHO98 TEQDF were 3,400 to air, 2,500 Center’s Public Reading Room is open 8691. If you are requesting a paper copy, to land, 30 to water, and 47 to products. from 8:30 a.m. to 4:30 p.m., Monday please provide your name, mailing For 2000, the releases in g WHO98 through Friday, excluding legal address, and the document title. TEQDF were 2,300 to air, 2,300 to land, holidays. The telephone number for the Comments may be submitted 28 to water, and 7 to products. This Public Reading Room is 202–566–1744. electronically via www.regulations.gov, document also provides limited Deliveries are only accepted during the by mail, by facsimile, or by hand estimates for releases of dioxin-like docket’s normal hours of operation, and delivery/courier. Please follow the polychlorinated biphenyls (PCBs). special arrangements should be made detailed instructions provided in the In comparison to the version of this for deliveries of boxed information. If SUPPLEMENTARY INFORMATION section of document released in 2006, estimates of you provide comments by hand this notice. CDD/CDF releases to air increased for delivery, please submit one unbound FOR FURTHER INFORMATION CONTACT: For all years. The changes reflect the original with pages numbered information on the public comment addition of new sources and consecutively and three copies of the period, contact the Office of adjustments to emission factors used for comments. For attachments, provide an Environmental Information Docket; municipal and medical waste index, number pages consecutively with telephone: 202–566–1752; facsimile: incinerators. The largest new source the comments, and submit an unbound 202–566–9744; or email: added was forest fires, which was original and three copies. [email protected]. previously classified as preliminary and Instructions: Direct your comments to For technical information, contact not included in the quantitative Docket ID No. EPA–HQ–ORD–2011– Matthew Lorber, NCEA; telephone: 703– inventory. Based on a number of new 0805. Please ensure that your comments 347–8535; facsimile: 703–347–8694; or studies, it was decided that sufficient are submitted within the specified email: [email protected]. data were now available to move this comment period. Comments received SUPPLEMENTARY INFORMATION: source into the quantitative inventory. after the closing date will be marked The forest fire releases in 2000 were ‘‘late,’’ and may only be considered if I. Information About the Document about four times higher than in 1987 time permits. It is EPA’s policy to The purpose of this document is to and in 1995 (due to more fires) causing include all comments it receives in the present a comprehensive inventory and a particularly large percent increase in public docket without change and to

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make the comments available online at ENVIRONMENTAL PROTECTION address below, written objections to the www.regulations.gov, including any AGENCY grant, together with supporting documentation. The documentation personal information provided, unless a [FRL–9843–9] comment includes information claimed from objecting parties having an interest to be Confidential Business Information Intent To Grant an Exclusive Patent in practicing the above patent should (CBI) or other information whose License include an application for an exclusive disclosure is restricted by statute. Do or nonexclusive license with the not submit information that you AGENCY: Environmental Protection information set forth in 37 CFR 404.8. consider to be CBI or otherwise Agency (EPA). The EPA Patent Attorney and other EPA officials will review all written protected through www.regulations.gov ACTION: Notice of intent to grant an responses and then make or email. The www.regulations.gov Web exclusive license. recommendations on a final decision to site is an ‘‘anonymous access’’ system, SUMMARY: EPA hereby gives notice of its the Director or Deputy Director of the which means EPA will not know your intent to grant an exclusive, royalty- National Risk Management Research identity or contact information unless bearing, revocable license to practice the Laboratory who have been delegated the you provide it in the body of your invention described and claimed in the authority to issue patent licenses under comment. If you send an email U.S. patent entitled PROCESS FOR THE EPA Delegation 1–55. comment directly to EPA without going BIODEGRADATION OF Dated: July 31, 2013. through www.regulations.gov, your HYDROCARBONS AND ETHERS IN Kevin Miller, email address will be automatically SUBSURFACE SOIL BY Acting Associate General Counsel, General captured and included as part of the INTRODUCTION OF A SOLID OXYGEN Law Office. comment that is placed in the public SOURCE BY HYDRAULIC [FR Doc. 2013–19075 Filed 8–6–13; 8:45 am] docket and made available on the FRACTURING, filed as U.S. serial BILLING CODE 6560–50–P Internet. If you submit an electronic number 10/395,893 on March 25, 2003 comment, EPA recommends that you and issued as U.S. Patent 7,252,986 on include your name and other contact August 7, 2007 to Foremost ENVIRONMENTAL PROTECTION information in the body of your Environmental Solutions, L.L.C. of AGENCY comment and with any disk or CD–ROM Denver, Colorado. [FRL–9843–4] you submit. If EPA cannot read your DATES: Comments on this notice must be comment due to technical difficulties received by EPA at the address listed Meeting of the National Drinking Water and cannot contact you for clarification, below by August 22, 2013. Advisory Council EPA may not be able to consider your FOR FURTHER INFORMATION CONTACT: comment. Electronic files should avoid Laura Scalise, Patent Attorney, Office of AGENCY: Environmental Protection the use of special characters, any form General Counsel (Mail Code 2377A), Agency (EPA). of encryption, and be free of any defects Environmental Protection Agency, ACTION: Notice of a public meeting. Washington, DC 20460, telephone (202) or viruses. For additional information SUMMARY: 564–8303. The U.S. Environmental about EPA’s public docket visit the EPA Protection Agency is announcing a Docket Center homepage at SUPPLEMENTARY INFORMATION: Pursuant meeting of the National Drinking Water www.epa.gov/epahome/dockets.htm. to 35 U.S.C. 207 (Patents) and 37 CFR Advisory Council (Council), established part 404 (U.S. Government patent Docket: Documents in the docket are under the Safe Drinking Water Act licensing regulations), EPA hereby gives (SDWA). This meeting is scheduled for listed in the www.regulations.gov index. notice of its intent to grant an exclusive, Although listed in the index, some October 9 and 10, 2013, in Arlington, royalty-bearing, revocable license to VA. The Council typically considers information is not publicly available, practice the invention described and e.g., CBI or other information whose various issues associated with drinking claimed in the U.S. patent entitled water protection and public water disclosure is restricted by statute. PROCESS FOR THE Certain other materials, such as systems. During this meeting, the BIODEGRADATION OF Council will focus discussions on the copyrighted material, are publicly HYDROCARBONS AND ETHERS IN proposed regulatory revisions to the available only in hard copy. Publicly SUBSURFACE SOIL BY Lead and Copper Rule under the SDWA available docket materials are available INTRODUCTION OF A SOLID OXYGEN as well as other program issues. either electronically at SOURCE BY HYDRAULIC DATES: The meeting on October 9, 2013 www.regulations.gov or in hard copy at FRACTURING, filed as U.S. serial will be held from 8:30 a.m. to 5:00 p.m., the OEI Docket in the EPA Headquarters number 10/395,893 on March 25, 2003 Eastern Time, and on October 10, 2013 and issued as U.S. Patent 7,252,986 on Docket Center. from 8:30 a.m. to 2:30 p.m., Eastern August 7, 2007 to Foremost Dated: May 2, 2013. Time. Environmental Solutions, L.L.C. of Debra B. Walsh, Denver, Colorado. ADDRESSES: The meeting will be held at Acting Deputy Director, National Center for The proposed exclusive license will the EPA Potomac Yard Conference Environmental Assessment. contain appropriate terms, limitations, Center at 2777 Crystal Drive, Arlington, [FR Doc. 2013–18954 Filed 8–6–13; 8:45 am] and conditions to be negotiated in Virginia, 22202, in room North 4830 BILLING CODE 6560–50–P accordance with 35 U.S.C. 209 and 37 (4th floor) and will be open to the CFR 404.5 and 404.7 of the U.S. public. All attendees must go through a Government patent licensing metal detector, sign in with the security regulations. desk, and show government issued EPA will negotiate the final terms and photo identification to enter government conditions and grant the exclusive buildings. license, unless within 15 days from the FOR FURTHER INFORMATION CONTACT: date of this notice EPA receives, at the Members of the public who would like

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to register and receive pertinent request accommodation of a disability, • Hand Delivery: EPA Docket Center, information, present an oral statement please contact Roy Simon at least 10 EPA West, Room 3334, 1301 or submit a written statement for the days prior to the meeting to give EPA as Constitution Avenue NW., Washington, October 9 and 10 meeting should much time as possible to process your DC, Attention Docket ID No. EPA–HQ– contact Roy Simon, by September 6; by request. OW–2010–0824. Such deliveries are email at [email protected]; by phone Dated: July 30, 2013. accepted only during the Docket at 202–564–3868; or by regular mail at Eric M. Bissonette, Center’s normal hours of operation, and U.S. Environmental Protection Agency, special arrangements should be made Acting Director, Office of Ground Water and Office of Ground Water and Drinking Drinking Water. for deliveries of boxed information. Water (MC 4601M), 1200 Pennsylvania Instructions: Direct your comments on [FR Doc. 2013–19080 Filed 8–6–13; 8:45 am] Avenue NW., Washington, DC, 20460. the 2011 Annual Reviews and Further details about participating in BILLING CODE 6560–50–P Preliminary 2012 Plan to Docket ID No. the meeting can be found in the EPA–HQ–OW–2010–0824. EPA’s policy is that all comments received will be SUPPLEMENTARY INFORMATION section. ENVIRONMENTAL PROTECTION included in the public docket without SUPPLEMENTARY INFORMATION: AGENCY Details about Participating in the change and could be made available Meeting: If you wish to attend the [EPA–HQ–OW–2010–0824; FRL—9678–5] online at www.regulations.gov, including any personal information meeting, you should provide your email RIN 2040–ZA18 provided, unless the comment includes address when you register. The EPA information claimed to be Confidential will provide updated information on the Preliminary 2012 Effluent Guidelines Business Information (CBI) or other October meeting to registered Program Plan and 2011 Annual information whose disclosure is individuals and organizations in Effluent Guidelines Review Report restricted by statute. Do not submit September 2013. The Council will AGENCY: Environmental Protection information that you consider to be CBI allocate one hour for the public’s input Agency (EPA). or otherwise protected through (1:00 p.m.–2:00 p.m., Eastern Time) at ACTION: Notice of availability. www.regulations.gov or email. The the meeting on Thursday, October 10, www.regulations.gov Web site is an 2013. Oral statements will be limited to SUMMARY: This notice announces the ‘‘anonymous access’’ system, which five minutes at the meeting. It is availability of the Preliminary 2012 means that EPA will not know your preferred that only one person present Effluent Guidelines Program Plan identity or contact information unless the statement on behalf of a group or (‘‘Preliminary 2012 Plan’’) and EPA’s you provide it in the body of your organization. To ensure adequate time 2011 Annual Effluent Guidelines comment. If you send an email for public involvement, individuals or Review Report, and solicits public comment directly to EPA without going organizations interested in presenting comment on both. Clean Water Act through www.regulations.gov your email an oral statement should notify Roy (CWA) section 304(m), 33 U.S.C. address will be automatically captured Simon no later than September 13, 1314(m), requires EPA to biennially and included as part of the comment 2013. Any person who wishes to file a publish a plan for new and revised that is placed in the public docket and written statement can do so before or effluent guidelines, after public notice made available on the Internet. If you after the Council meeting. Written and comment, which identifies any new submit an electronic comment, EPA statements intended for the meeting or existing industrial categories selected recommends that you include your must be received by September 27, for effluent guidelines rulemaking and name and other contact information in 2013, to be distributed to all members provides a schedule for such the body of your comment and with any of the Council before any final rulemaking. EPA works to publish a disk or CD–ROM you submit. If EPA discussion or vote is completed. Any preliminary plan in the odd numbered cannot read your comment because of statements received on or after the date years and a final plan in the even technical difficulties and cannot contact specified will become part of the numbered years. The findings from the you for clarification, EPA might not be permanent file for the meeting and will 2011 Annual Reviews were used in able to consider your comment. be forwarded to the Council members developing the Preliminary 2012 Plan Electronic files should avoid the use of for their information. and will be used in developing the Final special characters, any form of National Drinking Water Advisory 2012 Plan. encryption, and be free of any defects or Council: The Council was created by DATES: Submit comments on or before viruses. For additional information Congress on December 16, 1974, as part October 7, 2013. about EPA’s public docket visit the EPA of the SDWA of 1974, Public Law 93– ADDRESSES: Submit your comments on Docket Center homepage at http:// 523, 42 U.S.C. 300j–5, and is operated the 2011 Annual Reviews and www.epa.gov/epahome/dockets.htm. in accordance with the provisions of the Preliminary 2012 Plan identified by For additional instructions on Federal Advisory Committee Act Docket ID No. EPA–HQ–OW–2010– submitting comments, go to the (FACA), 5 U.S.C. App.2. The Council 0824, by one of the following methods: SUPPLEMENTARY INFORMATION section of was established under the SDWA to • http://www.regulations.gov: Follow this document. provide practical and independent the on-line instructions for submitting advice, consultation and Submitting Confidential Business comments. Information recommendations to the EPA • Email: [email protected], Administrator on the activities, Attention Docket ID No. EPA–HQ–OW– Do not submit confidential business functions, policies, and regulations 2010–0824. information (CBI) to EPA through required by the SDWA. • Fax: (202) 566–9744 www.regulations.gov or email. Any CBI Special Accommodations: For • Mail: Water Docket, Environmental you wish to submit should be sent via information on access or services for Protection Agency, Mailcode: 2822T, a trackable physical method, such as individuals with disabilities, please Attention Docket ID No. EPA–HQ–OW– Federal Express or United Parcel contact Roy Simon at 202–564–3868 or 2010–0824, 1200 Pennsylvania Ave. Service, to Mr. M. Ahmar Siddiqui, by email at [email protected]. To NW., Washington, DC 20460. Document Control Officer, Engineering

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and Analysis Division (4303T), Room B. How can I get copies of these A. Legal Authority 6231S EPA West, U.S. EPA, 1200 documents and other related This notice is published under the Pennsylvania Ave. NW., Washington, information? authority of the CWA, 33 U.S.C. 1251, DC 20460. A CBI package should be 1. Docket. EPA has established official et seq., and in particular sections 301(d), double-wrapped, so that the CBI is in public dockets for these actions under 304(b), 304(g), 304(m), 306, 307(b), 308, one package, which is itself inside Docket ID No. EPA–HQ–OW–2010– 33 U.S.C. 1311(d), 1314(b), 1314(g), another package. Clearly mark the part 0824. The official public docket is the 1314(m), 1316, 1317(b), and 1318. or all of the information that you claim collection of materials that is available to be CBI. For CBI information on a disk B. Summary Findings of the 2011 for public viewing at the Water Docket Annual Reviews or CD ROM that you mail to EPA, mark in the EPA Docket Center, (EPA/DC) the outside of the disk or CD ROM as EPA West, Room 3334, After completing the 2011 Annual CBI and then identify electronically 1301Constitution Ave. NW., Reviews, EPA has determined that within the disk or CD ROM the specific Washington, DC 20460. discharges from 17 of the top 20 information that is claimed as CBI. In 2. Electronic Access. You may access industrial categories were not a hazard addition to one complete copy of the this Federal Register document priority. However, EPA determined that material that includes information electronically through the United States additional information and analysis is claimed as CBI, a copy of the material government online source for Federal necessary before concluding the review that does not contain the information regulations at http:// of the three remaining point source claimed as CBI must be submitted for www.regulations.gov. categories: Pulp, Paper and Paperboard inclusion in the public docket. 3. Internet access. Copies of the (40 CFR Part 430), Petroleum Refining Information marked as CBI will not be supporting documents are available at (40 CFR Part 419), and Meat and Poultry disclosed except in accordance with http://water.epa.gov/lawsregs/ Products (40 CFR Part 432). Therefore, procedures set forth in 40 CFR Part 2. lawsguidance/cwa/304m/index.cfm. EPA continued to review these Docket: All documents in the docket categories’ discharges during the 2012 are listed in the index at C. What should I consider as I prepare Annual Reviews and will report its www.regulations.gov. Although listed in my comments for EPA? finding in the Final 2012 Plan. the index, some information is not Tips for Preparing Your Comments. C. Summary of the Preliminary 2012 publicly available, i.e., CBI or other When submitting comments, remember Effluent Guidelines Program Plan information whose disclosure is to: EPA is not identifying any industry restricted by statute. Certain other • Identify the rulemaking by docket material, such as copyrighted material, category for new or revised effluent number and other identifying guidelines in the Preliminary 2012 Plan. is not placed on the Internet and will be information (subject heading, Federal publicly available only in hard copy In addition, for previously initiated Register date and page number). rulemakings, EPA is proposing to delist form. Publicly available docket • Follow directions—The agency materials are available either from the effluent guidelines plan the might ask you to respond to specific rulemaking for the Coalbed Methane electronically at www.regulations.gov or questions or organize comments by Extraction subcategory based on new in hard copy at the Water Docket in the referencing a Code of Federal information regarding the declining EPA Docket Center, EPA/DC, EPA West, Regulations (CFR) part or section prevalence and economic viability of Room 3334, 1301 Constitution Ave. number. this industry, due in large part to the NW., Washington, DC. The Public • Explain why you agree or disagree, increased extraction of natural gas from Reading Room is open from 8:30 a.m. to suggest alternatives, and substitute other sources, such as shale formations. 4:30 p.m., Monday through Friday, language for your requested changes. See the supporting documents available excluding legal holidays. The telephone • Describe any assumptions and at http://water.epa.gov/lawsregs/ number for the Public Reading Room is provide any technical information and/ lawsguidance/cwa/304m/index.cfm for (202) 566–1744, and the telephone or data that you used. further explanation. EPA is also number for the Water Docket is (202) • If you estimate potential costs or proposing to delist the Chlorine and 566–2426. burdens, explain how you arrived at Chlorinated Hydrocarbon (CCH) FOR FURTHER INFORMATION CONTACT: Mr. your estimate in sufficient detail to manufacturing industry from the Plan William F. Swietlik, Engineering and allow for it to be reproduced. • and discontinue its rulemaking. Analysis Division, Office of Water, Provide specific examples to Based on a preliminary study that has 4303T, U.S. Environmental Protection illustrate your concerns, and suggest been completed, EPA has concluded Agency, 1200 Pennsylvania Avenue alternatives. that an effluent guideline revision is not • NW., Washington, DC., 20460; Explain your views as clearly as necessary for Regenerated Cellulose telephone number: (202) 566–1129; fax possible. Manufacturers (previously categorized • number: (202) 566–1053; email address: Make sure to submit your as Plastics Molding and Forming (40 [email protected]. comments by the comment period CFR Part 463)). deadline identified. SUPPLEMENTARY INFORMATION: D. Public Comments II. How is this document organized? I. General Information EPA also considered public comments The outline of this notice follows. A. Supporting Documents and information submitted by A. Legal Authority. stakeholders in response to a Key documents providing additional B. Summary Findings of the 2011 Annual solicitation for comments on the Final information about EPA’s 2011 Annual Reviews. C. Summary of the Preliminary 2012 Effluent 2010 Effluent Limitations Guidelines Reviews and the Preliminary 2012 Plan Guidelines Program Plan. (ELG) Program Plan (Final 2010 Plan), include the 2011 Annual Effluent D. Public Comments. published in the Federal Register on Guidelines Review Report and the E. Summary of the Planned Process for 2012 October 26, 2011 (76 FR 66286). Preliminary 2012 Effluent Guidelines Annual Reviews. A total of 31 organizations provided Program Plan. F. Requests for Comment and Information. comment on the Final 2010 Plan. Most

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of the public comment and input 2. Methodologies for the 2012 Annual harness innovation to solve industrial submitted focused on expressing Reviews wastewater problems, both now and opposition or support for the announced EPA solicits comments on its methods in the future? ELGs for Shale Gas Extraction, Coalbed for the 2012 Annual Reviews and for —How can EPA better foster Methane Extraction and Dental subsequent even numbered year consideration of innovative Amalgam. A few comments provided a reviews. EPA used targeted industrial technologies through the effluent small amount of information and ideas review methods during 2012, as guidelines planning process? on the 304(m) planning process in described above. Specifically, EPA Nancy K. Stoner, general; nanomaterial discharges; the solicits comment on data and other Acting Assistant Administrator for Water. disposal of unused pharmaceuticals; sources of available information or and on the ore mining and dressing [FR Doc. 2013–19074 Filed 8–6–13; 8:45 am] approaches that EPA could consider for BILLING CODE 6560–50–P study report. the annual reviews in subsequent even E. Summary of the Process for 2012 years, or comments regarding the Annual Reviews targeted approaches described above ENVIRONMENTAL PROTECTION and in the Preliminary 20122 Plan. AGENCY EPA conducted four new targeted review methodologies to better identify 3. The Preliminary 2012 Effluent [FRL–9844–5] new industries or industry processes at Guidelines Program Plan Proposed Consent Decree, Clean Air existing industries that may need new EPA solicits comments on its Act Citizen Suit or revised effluent guidelines and Preliminary 2012 Plan, including the standards for the 2012 reviews. These data and information used to support AGENCY: Environmental Protection methodologies included: the findings and conclusions stated in Agency (EPA). • Identifying pass-through pollutants the Preliminary 2012 Plan. EPA also ACTION: Notice of proposed consent in sewage sludge using the 2009 solicits comments on the proposed decree; request for public comment. Targeted National Sewage Sludge decisions to not identify any industry Survey (TNSSS). categories for the development of new SUMMARY: In accordance with section 113(g) of the Clean Air Act, as amended • Identifying new pollutants and or revised effluent guidelines and to (CAA or the Act), notice is hereby given industry discharges using data and delist the Coalbed Methane Extraction of a proposed consent decree to address information from EPA’s toxic substances subcategory and Chlorine and a lawsuit filed by Sierra Club (Plaintiff) control programs. Chlorinated Hydrocarbon Manufacturing from the effluent in the United States District Court for • Identifying new waste streams guidelines plan. the District of Columbia: Sierra Club v. generated from new air pollution Jackson, No.1:12–cv–01237–ESH controls associated with Clean Air Act 4. Implementation Issues Related to (D.D.C.). On or about July 26, 2012, the rulemakings. Existing Effluent Guidelines and plaintiff filed a complaint alleging that • Identifying new industries through Pretreatment Standards EPA had failed to take action on certain potential TRI expansion sectors. As a factor in its decision-making, State Implementation Plan (SIP) EPA considers opportunities to These new targeted review submittals by the states of New Jersey eliminate inefficiencies or impediments methodologies are further described in and Michigan. Specifically, the to pollution prevention or technological the Preliminary 2012 Plan available for complaint alleged that EPA had failed to innovation, or opportunities to promote review at: http://water.epa.gov/ make a finding that the state of New innovative approaches such as water lawsregs/lawsguidance/cwa/304m/ Jersey did not submit SIP revisions quality trading, including within-plant index.cfm. addressing the nonattainment New trading. Consequently, EPA solicits Source Review requirements for the EPA has modified its annual review comments on implementation issues 1997 fine particulate matter National process to conduct a toxicity ranking related to existing effluent guidelines Ambient Air Quality Standard (1997 analysis for industry only during the and pretreatment standards. PM2.5 NAAQS) in the State of New odd numbered years and additional Jersey portion of the Philadelphia- targeted reviews of industry during the 5. Innovation and Technology in the Effluent Guidelines Program Wilmington nonattainment area. The even numbered years. complaint further alleged that EPA had F. Request for Comment and EPA is requesting public comment failed to take final action on the Information and ideas on the subject of technology attainment demonstration, contingency innovation. EPA seeks public input and measures, emission inventory and EPA requests comments and comment on the following questions Reasonably Available Control Measures information on the Preliminary 2012 and related themes: or Reasonably Available Control Effluent Guidelines Program Plan and —Are there new, innovative pollution Technology (RACM/RACT), on the 2011 Annual Effluent Guidelines control or pollution prevention requirements for the 1997 PM2.5 NAAQS Review Report in the following areas. technologies that can be used by any in both the State of Michigan’s SIP 1. Data Sources and Methodologies of the existing 57 categories of submittal for the Detroit-Ann Arbor industry with effluent limitations nonattainment area and the New Jersey EPA solicits comments on whether it guidelines? SIP submittal for the State of New Jersey used the correct evaluation factors, —Are there innovative manufacturing portion of the Philadelphia-Wilmington criteria, and data sources in conducting approaches that can be used by nonattainment area. The complaint also its 2011 annual review and developing industries to reduce or prevent their alleged that EPA failed to publish a this Plan. EPA also solicits comment on wastewater discharges? notice of determination in the Federal other data sources EPA can use in its —How can EPA’s effluent limitations Register regarding whether the Detroit- annual reviews and biennial planning guidelines program enhance Ann Arbor area had attained the 1997 process. technology transfer to catalyze and PM2.5 NAAQS by the applicable

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attainment date. The proposed consent Reasonably Available Control number for the Public Reading Room is decree establishes deadlines for EPA to Technology (RACM/RACT), (202) 566–1744, and the telephone take certain actions. requirements for the 1997 PM2.5 NAAQS number for the OEI Docket is (202) 566– DATES: Written comments on the in the State of New Jersey SIP submittal 1752. proposed consent decree must be for the State of New Jersey portion of the An electronic version of the public received by September 6, 2013. Philadelphia-Wilmington docket is available through ADDRESSES: Submit your comments, nonattainment area. EPA is not www.regulations.gov. You may use the identified by Docket ID number EPA– required, however, to act on any www.regulations.gov to submit or view HQ–OGC–2013–0553, online at submission or portion thereof that is public comments, access the index www.regulations.gov (EPA’s preferred withdrawn prior to the applicable listing of the contents of the official method); by email to deadline. Because the state of Michigan public docket, and to access those [email protected]; mailed to EPA withdrew its SIP submission for the documents in the public docket that are Docket Center, Environmental attainment demonstration for the available electronically. Once in the Protection Agency, Mailcode: 2822T, Detroit-Ann Arbor 1997 PM2.5 system, select ‘‘search,’’ then key in the 1200 Pennsylvania Ave. NW., nonattainment area, on May 20, 2013, appropriate docket identification Washington, DC 20460–0001; or by the proposed consent decree does not number. hand delivery or courier to EPA Docket require EPA to act on this submission or It is important to note that EPA’s Center, EPA West, Room 3334, 1301 any portion thereof. policy is that public comments, whether Constitution Ave. NW., Washington, The proposed consent decree also submitted electronically or in paper, DC, between 8:30 a.m. and 4:30 p.m. states that the consent decree can be will be made available for public Monday through Friday, excluding legal modified by either the parties, or the viewing online at www.regulations.gov holidays. Comments on a disk or CD– court following a motion by a party and without change, unless the comment ROM should be formatted in Word or a response thereto. In addition, the contains copyrighted material, CBI, or ASCII file, avoiding the use of special parties agree to informally resolve Sierra other information whose disclosure is characters and any form of encryption, Club’s claim for litigation costs pursuant restricted by statute. Information and may be mailed to the mailing to section 304(d), 42 U.S.C. 7604(d), but claimed as CBI and other information address above. that the court would retain jurisdiction whose disclosure is restricted by statute is not included in the official public FOR FURTHER INFORMATION CONTACT: to resolve that claim. docket or in the electronic public Winifred N. Okoye, Air and Radiation For a period of thirty (30) days following the date of publication of this docket. EPA’s policy is that copyrighted Law Office (2344A), Office of General material, including copyrighted material Counsel, U.S. Environmental Protection notice, the Agency will receive written comments relating to the proposed contained in a public comment, will not Agency, 1200 Pennsylvania Ave. NW., be placed in EPA’s electronic public Washington, DC 20460; telephone: (202) consent decree from persons who were not named as parties or intervenors to docket but will be available only in 564–5446; fax number (202) 564–5603; printed, paper form in the official public email address: [email protected]. the litigation in question. EPA or the Department of Justice may withdraw or docket. Although not all docket SUPPLEMENTARY INFORMATION: withhold consent to the proposed materials may be available electronically, you may still access any I. Additional Information About the consent decree if the comments disclose of the publicly available docket Proposed Consent Decree facts or considerations that indicate that such consent is inappropriate, materials through the EPA Docket The proposed consent decree would Center. resolve a lawsuit seeking to compel improper, inadequate, or inconsistent action by the Administrator to take final with the requirements of the Act. Unless B. How and to whom do I submit action under section 110(k)(3) and (4), EPA or the Department of Justice comments? 42 U.S.C. 7410(k)(3) and (4), to approve determines, based on any comment You may submit comments as which may be submitted, that consent to or disapprove, in whole or in part provided in the ADDRESSES section. certain States of New Jersey and the consent decree should be Please ensure that your comments are Michigan SIP submittals. withdrawn, the terms of the decree will submitted within the specified comment The proposed consent decree requires be affirmed. period. Comments received after the EPA, on or before September 30, 2013, II. Additional Information About close of the comment period will be to sign and thereafter promptly forward Commenting on the Proposed Consent marked ‘‘late.’’ EPA is not required to to the Office of Federal Register for Decree consider these late comments. review and publication a notice of final If you submit an electronic comment, action addressing whether the State of A. How can I get a copy of the consent EPA recommends that you include your New Jersey has failed to submit SIP decree? name, mailing address, and an email revisions addressing the nonattainment Direct your comments to the official address or other contact information in New Source Review requirements for public docket for this action under the body of your comment and with any the 1997 PM2.5 NAAQS in the State of Docket ID No. EPA–HQ–OGC- 2013– disk or CD ROM you submit. This New Jersey portion of the Philadelphia- 0553, which contains a copy of the ensures that you can be identified as the Wilmington nonattainment area. The consent decree. The official public submitter of the comment and allows proposed consent decree also requires docket is available for public viewing at EPA to contact you in case EPA cannot EPA, on or before November 30, 2013, the Office of Environmental Information read your comment due to technical to sign and thereafter promptly forward (OEI) Docket in the EPA Docket Center, difficulties or needs further information to the Office of Federal Register for EPA West, Room 3334, 1301 on the substance of your comment. Any review and publication a notice taking Constitution Ave. NW., Washington, identifying or contact information final action on the attainment DC. The EPA Docket Center Public provided in the body of a comment will demonstration, contingency measures, Reading Room is open from 8:30 a.m. to be included as part of the comment that emission inventory and Reasonably 4:30 p.m., Monday through Friday, is placed in the official public docket, Available Control Measures or excluding legal holidays. The telephone and made available in EPA’s electronic

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public docket. If EPA cannot read your Parties: Port of Anacortes; Port of SUMMARY: On June 26, 2013, the comment due to technical difficulties Astoria; Port of Bellingham; Port of Coos Department of Health and Human and cannot contact you for clarification, Bay; Port of Everett; Port of Grays Services (HHS) published in the Federal EPA may not be able to consider your Harbor; Port of Kalama; Port of Register an announcement of a public comment. Longview; Port of Olympia; Port of Port meeting to be held on August 28, 2013, Use of the www.regulations.gov Web Angeles; Port of Portland; Port of to discuss how certain provisions of the site to submit comments to EPA Seattle; Port of St. Helens; Port of HHS protection of human subjects electronically is EPA’s preferred method Tacoma; and Port of Vancouver, USA. should be applied to research studying for receiving comments. The electronic Filing Party: Patti A. Fulghum; one or more interventions which are public docket system is an ‘‘anonymous Executive Officer; Northwest Marine used as standard of care treatment in the access’’ system, which means EPA will Terminal Association, Inc.; P.O. Box non-research context (78 FR 38343). not know your identity, email address, 5684; Bellevue, WA 98006. In the June 26, 2013 meeting or other contact information unless you Synopsis: The amendment reflects the announcement, HHS stated that provide it in the body of your comment. addition of the Port of St. Helens, presenters will be scheduled to speak at In contrast to EPA’s electronic public Oregon as member to the agreement. the public meeting in the order in which docket, EPA’s electronic mail (email) Agreement No.: 012184–001. they register. Notice is hereby provided system is not an ‘‘anonymous access’’ Title: Crowley/Maersk Line Panama— that HHS may group presenters system. If you send an email comment U.S. Space Charter Agreement. according to the topic of their Parties: Crowley Latin America directly to the Docket without going presentation. through www.regulations.gov, your Services, LLC and A.P. Moller-Maersk FOR FURTHER INFORMATION CONTACT: Dr. email address is automatically captured A/S. Jerry Menikoff, Director, Office for and included as part of the comment Filing Party: Wayne R. Rohde, Esq.; Human Research Protections, that is placed in the official public Cozen O’Connor; 1627 I Street NW., Department of Health and Human docket, and made available in EPA’s Suite 1100; Washington, DC 20006– Services, 1101 Wootton Parkway, Suite electronic public docket. 4007. Synopsis: The agreement adjusts the 200; Rockville, MD 20852, 240–453– Dated: July 31, 2013. amount of space and the number of 6900; email [email protected]. Lorie J. Schmidt, reefer plugs to be provided. DATED: August 1, 2013. Associate General Counsel. Agreement No.: 201162–010. Title: NYSA-ILA Assessment Howard K. Koh, [FR Doc. 2013–19073 Filed 8–6–13; 8:45 am] Assistant Secretary for Health. BILLING CODE 6560–50–P Agreement. Parties: International Longshoremen’s [FR Doc. 2013–19056 Filed 8–6–13; 8:45 am] Association and New York Shipping BILLING CODE 4150–36–P FEDERAL MARITIME COMMISSION Association. Filing Parties: Donato Caruso, Esq.; DEPARTMENT OF HEALTH AND Notice of Agreements Filed The Lambos Firm; 303 South Broadway, Suite 410; Tarrytown, NY 10591 and HUMAN SERVICES The Commission hereby gives notice Andre Mazzola, Esq.; Marrinan & of the filing of the following agreements Mazzola Mardon, P.C.; 26 Broadway, Centers for Disease Control and under the Shipping Act of 1984. 17th Floor; New York, NY 10004. Prevention Interested parties may submit comments Synopsis: The amendment extends Board of Scientific Counselors, on the agreements to the Secretary, the agreement and reduces the National Center for Health Statistics Federal Maritime Commission, assessment for all house containers Washington, DC 20573, within ten days within 260 miles, except in the In accordance with section 10(a)(2) of of the date this notice appears in the Bermuda trade effective August 1, 2013. the Federal Advisory Committee Act Federal Register. Copies of the Dated: August 2, 2013. (Pub. L. 92–463), the Centers for Disease agreements are available through the By Order of the Federal Maritime Control and Prevention (CDC), National Commission’s Web site (www.fmc.gov) Commission. Center for Health Statistics (NCHS) or by contacting the Office of Rachel E. Dickon, announces the following meeting of the Agreements at (202) 523–5793 or Assistant Secretary. aforementioned committee: [email protected]. [FR Doc. 2013–19081 Filed 8–6–13; 8:45 am] TIMES AND DATES: 11:00 a.m.—5:30 p.m., Agreement No.: 002206–006. BILLING CODE P September 19, 2013; 8:30 a.m.—1:00 Title: California Association of Port p.m., September 20, 2013. Authorities—Northwest Marine PLACE: NCHS Headquarters, 3311 Terminal Association Terminal Toledo Road, Hyattsville, Maryland Discussion Agreement. DEPARTMENT OF HEALTH AND Parties: California Association of Port HUMAN SERVICES 20782 Authorities and Northwest Marine STATUS: This meeting is open to the Notice of a Department of Health and Terminal Association. public; however, visitors must be Filing Party: Patti A. Fulghum, Human Services Public Meeting and processed in accordance with Executive Officer; Northwest Marine Request for Comments on Matters established federal policies and Terminal Association; P.O. Box 5684; Related to the Protection of Human procedures. For foreign nationals or Bellevue, WA 98006. Subjects and Research Studying non-US citizens, pre-approval is Synopsis: The amendment reflects the Standard of Care Interventions; required (please contact Gwen Mustaf, addition of the Port of St. Helens, Amended Notice of Meeting 301–458–4500, [email protected] or Oregon as a member to the Northwest AGENCY: Office of the Secretary, Virginia Cain, [email protected] at least 10 Marine Terminal Association. Department of Health and Human days in advance for requirements). All Agreement No.: 009335–007. Services. visitors are required to present a valid Title: Northwest Marine Terminal form of picture identification issued by ACTION: Notice. Association, Inc. Agreement. a state, federal or international

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government. As required by the Federal DEPARTMENT OF HEALTH AND • What constitutes a complete, formal Property Management Regulations, Title HUMAN SERVICES request for an NCD or formal request for 41, Code of Federal Regulation, Subpart reconsideration of an existing NCD. 101–20.301, all persons entering in or Centers for Medicare & Medicaid • External requests for NCDs, on Federal controlled property and their Services including the following: packages, briefcases, and other [CMS–3284–N] ++ Request by an external party for a containers in their immediate new NCD. possession are subject to being x-rayed Medicare Program; Revised Process ++ Request by an external party for and inspected. Federal law prohibits the for Making National Coverage reconsideration of an existing NCD. knowing possession or the causing to be Determinations ++ Request by an aggrieved party (as present of firearms, explosives and other defined below) to issue an NCD when AGENCY: Centers for Medicare & no NCD exists. dangerous weapons and illegal Medicaid Services (CMS), HHS. • substances. The meeting room CMS internally-generated review of ACTION: Notice. accommodates approximately 100 NCDs, including the following: ++ CMS internal review for a new people. SUMMARY: This notice updates the NCD. PURPOSE: This committee is charged process we use for opening, deciding or ++ CMS internal review for with providing advice and making reconsidering national coverage reconsideration of an existing NCD. recommendations to the Secretary, determinations (NCDs) under the Social • An expedited process to remove Department of Health and Human Security Act (the Act). It addresses NCDs under certain circumstances. Services; the Director, CDC; and the external requests and internal reviews Based on our experience since 2003 for new NCDs or for reconsideration of Director, NCHS, regarding the scientific with the current NCD process, we are existing NCDs. The notice further and technical program goals and establishing a new procedure to be used outlines an expedited administrative in circumstances in which we have objectives, strategies, and priorities of process to remove certain NCDs, thereby NCHS. previously issued an NCD, but have enabling local Medicare contractors to now determined that the NCD is no MATTERS TO BE DISCUSSED: The agenda determine coverage under the Act. This longer needed. Since we would not be will include welcome remarks by the notice does not alter or amend our establishing a new NCD, we would use Acting Director, NCHS; Demo of the regulations that establish rules related to an expedited process to remove these NHIS Online Analytic Real-time System the administrative review of NCDs. NCDs. After the effective date of the (OARS); initiation of Office of Analysis DATES: This notice is effective on removal of the NCD, local Medicare and Epidemiology review. August 7, 2013. contractors would determine coverage Requests to make oral presentations FOR FURTHER INFORMATION CONTACT: under section 1862(a)(1) of the Act for should be submitted in writing to the Katherine Tillman, (410) 786–9252. those specific items or services contact person listed below. All requests SUPPLEMENTARY INFORMATION: previously addressed through the NCD. must contain the name, address, We describe this process and the I. Background opportunity for public participation in telephone number, and organizational this process in section IV.C of this affiliation of the presenter. In a September 26, 2003, Federal Register notice (68 FR 55634), we notice. Written comments should not exceed announced our procedures for We are also restating our process for five single-spaced typed pages in length considering national coverage developing an NCD to provide clarity and must be received by September 4, determination (NCD) requests and our and transparency for the public 2013. procedure for issuing NCDs, including pertaining to modifications made to the The agenda items are subject to the role of external public requests to coverage process since the MMA. As in change as priorities dictate. open an NCD and our procedures for the 2003 Federal Register notice, we internally-generated NCD reviews. As will inform the public by addressing the CONTACT PERSON FOR MORE INFORMATION: we strive to continually improve our following in this notice: Virginia S. Cain, Ph.D., Director of processes and in recognition of the • The internal and external processes Extramural Research, NCHS/CDC, 3311 changes made by the Medicare for requesting an NCD or an NCD Toledo Road, Room 7208, Hyattsville, Prescription Drug, Improvement, and reconsideration. Maryland 20782, telephone (301) 458– Modernization Act of 2003 (MMA) (Pub. • A tracking system that provides 4500, fax (301) 458–4020. L. 108–173, enacted on December 8, public notice of our acceptance of a The Director, Management Analysis 2003), we are superseding the 2003 complete, formal request and and Services Office, has been delegated Federal Register notice with this subsequent actions in a web-based updated notice. format. the authority to sign Federal Register • notices pertaining to announcements of The process we use to afford notice II. Provisions of the Notice and opportunity for public comment meetings and other committee This notice establishes the procedures before issuing a decision memorandum. management activities for both Centers for requesting an NCD or • How we use public comments to for Disease Control and Prevention and reconsideration of an existing NCD. We inform the NCD final decision. the Agency for Toxic Substances and also describe how the public may We continue to pursue our efforts to Disease Registry. participate in the NCD process during work with various sectors of the Elaine L. Baker, the indicated comment period(s). The scientific and medical community to Management Analysis and Services Office, topics addressed in the notice include develop and publish on our Web site Centers for Disease Control and Prevention. the following: documents that describe our approach • Informal contacts and inquiries when analyzing scientific and clinical [FR Doc. 2013–19099 Filed 8–6–13; 8:45 am] prior to requesting a national coverage evidence to develop an NCD. The CMS BILLING CODE 4163–18–P determination. coverage Web site can be accessed at

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http://www.cms.gov/Medicare/ XVIII of the Act. NCDs are controlling review process) for at least one Coverage/CoverageGenInfo/index.html. authorities for Medicare contractors and indication to be eligible for adjudicators as described more fully in consideration of Medicare coverage III. Medicare Coverage—General 42 CFR 405.1060. (except in specific circumstances). Principles In the absence of an NCD, Medicare However, FDA approval or clearance A. Statutory Authority contractors may establish a local alone does not entitle that technology to coverage determination (LCD) (defined The Medicare program was Medicare coverage. in section 1869(f)(2)(B) of the Act) or established by Title XVIII of the Act. adjudicate claims on a case-by-case IV. CMS’ Process for Making a National Part A is the hospital insurance program basis. The case-by-case adjudicatory Coverage Determination and Part B is the voluntary model permits consideration of a supplementary medical insurance Section 1862(l) of the Act establishes, beneficiary’s particular factual program. The scope of benefits available among other things, a timeframe for the circumstances described in the medical to eligible beneficiaries under Part A NCD process and an opportunity for record. The case-by-case model affords and Part B is prescribed by law in public comment on the agency’s more flexibility to consider a particular proposed decisions. sections 1812 and 1832 of the Act. Part individual’s medical condition than is C, known as the Medicare Advantage possible when the agency establishes a A. Informal Contacts and Inquiries Program, includes at a minimum, all of generally applicable rule. Before Requesting an NCD the items and services available under Part A and Part B to individuals B. Differences Between Food and Drug We encourage, but do not require, enrolled in the plan. On January 1, Administration (FDA) and CMS Review potential requesters to communicate, via 2006, Medicare began to cover Parties interested in the coverage of a conference call or meeting, with our prescription drugs through a new drug or device may contact us with an staff in the Coverage and Analysis voluntary and privately-administered inquiry on Medicare coverage while the Group (CAG) within the Center for Part D program, established by the particular drug or device is proceeding Clinical Standards and Quality (CCSQ) MMA. To obtain prescription drug through the Food and Drug before submission of a formal request. coverage, Medicare beneficiaries must Administration (FDA) review process. We have found that an initial take the affirmative step of enrolling in Since the FDA is charged with submission of a ‘‘formal request’’ a private Medicare Part D plan that is regulating whether devices or without any conversation with us either a stand-alone prescription drug pharmaceuticals are safe and effective generally requires additional plan (PDP) or a Medicare Advantage for their intended use by consumers, clarification and discussion before we prescription drug plan (MA–PD). generally we will not accept a coverage can definitively act on the request. A In addition, with relatively few request for a device or pharmaceutical summary of the item or service and exceptions, the statute provides in that has not been approved or cleared supporting documentation can be section 1862(a)(1) of the Act that no for marketing by the FDA for at least one presented by the requester, and our staff payment may be made under Part A or indication; one exception is Category B can identify additional information that Part B for any expenses incurred for Investigational Device Exemption (IDE) might be needed or helpful. Preliminary items or services which ‘‘are not devices. A Category B IDE device is a discussions are also the appropriate reasonable and necessary for the non-experimental/investigational device time for the requester to identify clinical diagnosis or treatment of illness or for which the incremental risk is the trial protocols whose results will be injury or to improve the functioning of primary risk in question (that is, later submitted to support an NCD a malformed body member.’’ The underlying questions of safety and request, if relevant. A positive response, Supreme Court has recognized that effectiveness of that device type have however, to a clinical trial protocol is ‘‘[t]he Secretary’s decision as to whether been resolved), or it is known that the not an indication of forthcoming a particular medical service is device type can be safe and effective Medicare coverage. ‘reasonable and necessary’ and the because, for example, other A significant proportion of potential means by which she implements her manufacturers have obtained FDA requesters have either withdrawn or decision, whether by promulgating a approval or clearance for that device substantially amended their initial generally applicable rule or by allowing type. requests after informal discussion with individual adjudication, are clearly Both CMS and FDA review scientific us. These instances have generally discretionary decisions.’’ Heckler v. evidence and will likely review some of included one or more of the following Ringer, 466 U.S. 602, 617 (1984). the same evidence to meet each agency’s factors: This notice concerns our procedures mission. Among other things, FDA • Existing coverage of the item or for making NCDs for items and services reviews evidence to determine that a service is already available at the under Part A or Part B. NCDs serve as product is safe and effective, that is, it national or local level. generally applicable rules to ensure that conducts a premarket review of • similar claims for items or services are products under a statutory standard and The substance of the request covered in the same manner. Often an delegated authority (67 FR 66755) concerns the coding or payment amount NCD is written in terms of defined different from that of CMS. We also for the item or service and is therefore clinical characteristics that identify a review clinical evidence to determine, outside the scope of an NCD. population that may or may not receive among other things, whether the item or • The item or service falls outside the Medicare coverage for a particular item service is reasonable and necessary for scope of the Medicare Part A and Part or service. The term ‘‘national coverage the diagnosis or treatment of illness or B benefits. determination’’ is defined by statute and injury or to improve the functioning of • The requester learns that the item or means a determination by the Secretary a malformed body member for the service, even if covered, would not be of the Department of Health and Human affected Medicare beneficiary separately paid under the Medicare Services (Secretary) with respect to population. An FDA-regulated product program, for example, the item or whether or not a particular item or must receive FDA approval or clearance service would be included in a bundled service is covered nationally under Title (unless exempt from the FDA premarket payment.

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• The requester recognizes the a medical device at least 90 days in the item or service for which the request request would not be supported by a advance.) is made. persuasive body of evidence. • In the case of items or services that C. External Requests for National Informal communications between us are eligible for a 510(k) clearance by the Coverage Determinations and the requester allow both parties to FDA, the request must include clarify the NCD request and discuss identification of the predicate devices to 1. Request by an External Party for a potential issues that would affect our which the item or service is claimed to New National Coverage Determination review and implementation of coverage be substantially equivalent. Typically, a requester is a Medicare of the item or service, such as the issues • The request must include beneficiary, a manufacturer, a physician discussed above. These meetings and information regarding the use of an item or a physician professional association. conversations expedite consideration or service (for example, drug or device) A request may be to establish, limit, or and ensure that the requester subject to FDA regulation as well as the entirely remove coverage. understands that all relevant materials status of current FDA regulatory review Upon acceptance of a complete, must be submitted in a timely manner of the item or service involved. An FDA formal request, publication of a tracking and not delay the opening of the NCD regulated item or service would include sheet on the CMS Web site enables review. the labeling submitted to FDA or interested individuals to participate in B. What Constitutes a Complete, Formal approved by the FDA for that article, and monitor the progress of our review. Request for an NCD or a Complete, together with an indication of whether The tracking sheet contains a reference Formal Request for Reconsideration the article for which review is being number, the name of the issue under requested is covered under the labeled We can initiate an NCD request or one consideration, requests for public indication(s). We recognize that the can be initiated by an individual, comments, and summarizes the labeling on FDA-approved products (including a beneficiary), or an entity significant actions we have taken. The sometimes changes. For purposes of our (including a medical professional tracking sheet is a key element in review, we are interested in the labeled society or business interest). We require making our NCD process efficient, open, indications at the time a requester that any request for an NCD review be and accessible to the public. submits a formal request. If during our a written ‘‘complete, formal request.’’ A formal evidence review is then review, the labeled indication or status Acceptance of a complete, formal undertaken to determine whether or not request indicates that we have sufficient of pending FDA approval or clearance an unbiased interpretation of the information to conduct the NCD review. changes, the requester must notify us of available evidence base supports or those changes. refutes the requested coverage in whole A request is considered to be a • complete, formal request once the The request must state the Medicare or in part. A proposed decision is following conditions are met: Part A or Part B benefit category or normally issued for public comment • The requester has provided a final categories in which the requester within six months of opening the NCD letter of request that is not marked as a believes the item or service falls. review. Consistent with section draft, and is clearly identified as ‘‘A Medicare does not develop NCDs to 1862(l)(3)(B) of the Act, we provide 30 Formal Request for a National Coverage establish coverage of items or services days for public comment on the Determination.’’ The requester must that fall outside the scope of the Part A proposal. Not later than 60 days after identify and submit the scientific or Part B benefits. the close of the 30-day public comment • evidence that he or she believes Requests for NCDs may be period, we issue a final NCD. The final supports the request for coverage. Our submitted electronically via the NCD decision memorandum includes a review, however, is not limited to the Coverage Center Web site using the summary of the public comments on the materials submitted by the requester. ‘‘Contact Us’’ link at http:// proposed decision as well as responses • Supporting documentation must www.cms.gov/Medicare/Coverage/ to those comments. The proposed and include a full and complete description InfoExchange/contactus.html. final memoranda also include the of the item or service in the request and Requests may also be submitted to the scientific basis for our coverage scientific evidence supporting the Centers for Medicare & Medicaid determination, for example, an analysis clinical indications for the item or Services; Director, Coverage and and summary of the evidence service. This includes a specific detailed Analysis Group; 7500 Security Blvd.; considered (including medical, description of the proposed use of the Baltimore, MD 21244. technical, and scientific evidence). The item or service, including the target We will consider a request to be a statutory timeframes, however, vary Medicare population and the medical complete, formal request if the depending on whether or not we indication(s) for which it can be used following conditions are met: commission a technology assessment and whether the item or service is • The request is in writing. from an outside entity, or whether we intended for use by health care • The request clearly identifies the decide to convene the Medicare providers or beneficiaries. statutorily-defined benefit category to Evidence Development and Coverage • If the requester has submitted an which the requester believes the item or Advisory Committee (MEDCAC) to application to the FDA for premarket service applies and contains enough discuss the quality of the evidence, or approval or 510(k) clearance of the information for us to make a benefit whether a clinical trial is requested. product for which coverage is sought, a category determination. copy of the ‘‘integrated summary of • The request is accompanied by 2. Request by an External Party for safety data’’ and ‘‘integrated summary of sufficient, supporting evidentiary Reconsideration of an Existing NCD effectiveness data’’, or the combined documentation. When an NCD currently exists, any ‘‘summary of safety and effectiveness • The information provided addresses individual or entity may request that we data’’ portions of the FDA application relevance, usefulness, or the medical reconsider any provision of that NCD by must be included. (Section 510(k) of the benefits of the item or service to the filing a complete formal request for Food, Drug, and Cosmetic Act requires Medicare population. reconsideration. Similar to a request for device manufacturers who must register, • The information fully explains the a new NCD, the request for to notify FDA of their intent to market design, purpose, and method of using reconsideration must be submitted in

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writing and be clearly identified. We 3. Request by an Aggrieved Party To population, target subgroup consider accepting a request to revise an Issue a Coverage or Noncoverage NCD populations, practitioner or facility existing NCD at any time, but only if the Section 1869(f)(4) of the Act permits qualifications, etc., or on beneficiary requester presents documentation that certain aggrieved persons to make a health outcomes. Under these meets one of the following criteria: particularly complex circumstances, we • request that the Secretary issue a Additional scientific evidence that national coverage or noncoverage may also require a comprehensive was not considered during the most determination with respect to a technology assessment, or convene a recent review along with a sound particular type or class of items or MEDCAC meeting to discern and premise by the requester that new services, if the Secretary has not made evaluate those complexities and help evidence may change the NCD decision. inform our national decision. • Plausible arguments that our a national coverage or noncoverage conclusion materially misinterpreted determination. These individuals are 2. Internally-Generated NCD the existing evidence at the time the described in section 1869(f)(5) of the Reconsideration Review NCD was decided. Act as ‘‘individuals entitled to benefits We may also internally open a Similar to a request for a new NCD, under Part A, or enrolled under Part B, reconsideration of any policy or of an we consider a reconsideration request to or both, who are in need of the item or entire NCD. Generally, we internally be a ‘‘complete, formal request’’ if the service that is the subject of the open an NCD reconsideration because following conditions are met: coverage determination.’’ Thus, this we have become aware of new evidence • The requester provides a final letter option can be invoked only for an initial that could support a material change in of request (for example, not marked as request if we have not issued a coverage coverage and we seek public comment a ‘‘draft’’), and clearly identifies the or noncoverage NCD. In these rare on relevant questions. request as a ‘‘Formal Request for NCD instances related to requests made by Reconsideration.’’ aggrieved parties, the statute establishes E. Expedited Process To Remove an • The requester identifies the specific time deadlines for our NCD Using Certain Criteria scientific evidence that he or she consideration of such requests and we We recognize the need to periodically believes supports the request for will notify the public through the review our policies and processes to reconsideration (see above). Our review, posting of the NCD Tracking sheet when ensure that we remain effective and however, is not limited to the materials this occurs. efficient as well as open and submitted by the requester. D. Internally-Generated NCD Review transparent. We are aware that clinical • The written request includes and science and technology evolve and that supports any additional Medicare Part A 1. Internally-Generated Review of an items and services that were once or Part B benefit categories in which the NCD considered state-of-the-art or cutting requester believes the item or service We may internally initiate the NCD edge may be replaced by more beneficial falls. process. The following are examples of technologies or clinical paradigms. • The request includes supporting circumstances that may prompt us, Therefore, we are announcing an documentation and is received when supported by our initial administrative procedure to periodically electronically (unless there is good investigation of available evidence for review the inventory of NCDs that are cause for only a hardcopy submission review, to generate an internal NCD older than 10 years since their most such as inability to scan necessary review on new or longstanding items or recent review and evaluate the documents for electronic submission or services: continued need for those policies to lack of access to an electronic method • Practitioners, patients, or other remain active on a national scale. We of submission). Requests for NCDs may members of the public have raised are administratively simplifying the be submitted electronically via the significant questions about the health Medicare program by removing NCDs in Coverage Center Web site using the outcomes attributable to the use of the circumstances described below. This ‘‘Contact Us’’ link. Requests may also be items or services for the Medicare process of removal would not result in submitted to the Centers for Medicare & beneficiary population. an NCD as that term is defined in Medicaid Services; Director, Coverage • New evidence or reasonable re- sections 1869(f) and 1862(l) of the Act and Analysis Group; 7500 Security interpretation of previously available because there would be no uniform Blvd.; Baltimore, MD 21244. evidence indicates that a national national decision about whether or not We review materials presented in a coverage review may be warranted. the particular item or service would be complete, formal request by the • Local coverage policies on a covered under Title XVIII of the Act. requester. We also review other related particular item or service may vary in Rather, the initial coverage decision clinical materials before accepting a language or implementation. While this under section 1862(a)(1)(A) of the Act request for reconsideration. In a change may be manifested by LCD variations for the particular item or service would from the 2003 Federal Register notice among Medicare Administrative be made by local contractors. We and because of the time required for Contractors (MACs), we note that believe that allowing local contractor clinical research, reviews and analysis variability is not a de facto sign of discretion in these cases better serves in a global health arena, we have inappropriate local policy and may be the needs of the Medicare program and determined that 60 days is usually a appropriate. its beneficiaries since we believe the reasonable time period for us to make a • The health technology represents a future utilization for items and services decision to accept or reject decline an substantial clinical advance and is within these policies will be limited. external NCD reconsideration request. If likely to result in a significant This expedited procedure allows us to we accept the request, we post the letter improvement in patient health regularly identify and remove NCDs that requesting reconsideration together with outcomes or positive impact on the no longer contain clinically pertinent a tracking sheet announcing that a Medicare program. and current information or that involve reconsideration of the NCD has begun. • When rapid diffusion of an item or items or services that are used If we decline the request, we will send service is anticipated the evidence may infrequently by beneficiaries. As the a letter to the requester, rejecting the inadequately address questions scientific community continues to reconsideration request. regarding impact on the Medicare pursue research in certain areas, the

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evidence base we previously reviewed • The national policy does not meet While the statute affords an may have evolved to support other the definition of an ‘‘NCD’’ as defined opportunity for public comment on the policy conclusions. Alternatively, in in sections 1862(l) or 1869(f) of the Act. proposed decisions, we may also solicit some circumstances, removing an NCD • The benefit category determination public comment upon the initial has the effect of striking national is no longer consistent with a category opening of an NCD review announced noncoverage and may permit access to in the Act. via the tracking sheet. We use the initial technologies that may be beneficial for public comments to inform our some limited uses. V. CMS’ Evaluation of Requests for an proposed decision and respond in detail Under this process, we will NCD and Related Tasks to the public comments on a proposed periodically publish on our Web site, a When we receive a request for an decision when issuing the final decision list of NCDs proposed for removal along NCD, we review the submitted material memorandum. with our rationale for their proposed to determine if it is a complete, formal Also, we may, at our discretion, open removal. We will solicit public written request. If it is not a complete, a proposed decision concurrently with comment for 30 calendar days. This will formal request it does not trigger the the notice of opening an NCD. This invite the public to comment on NCD statutory timeline because we do occurs rarely when we determine it is whether any or all of these NCDs should not have a clear basis upon which to act efficient to reduce the time necessary to be removed or retained. In addition, we on the inquiry. In these instances, we manage an unforeseen health related will ask the commenters to include a notify the requester and explain our issue or program need that must be rationale to support their comments. We rationale, so the requester has the resolved quickly. We may also use our use the public comments to help inform opportunity to provide missing discretion, as we have publicly stated, our decision to do one of the following: information. As we explain elsewhere in in an attempt to expedite a final NCD for • Follow the proposal to remove the this notice, many of the incomplete or requests that are accepted in the FDA NCD. informal inquiries we have received in CMS parallel review project (see the • Retain the policy as an NCD. the past did not ultimately result in a notice published on October 11, 2011 • Formally reconsider the NCD and formal request. (76 FR 62808 through 62810)). post a tracking sheet to that effect on the Upon acceptance of a complete, Public comments providing Coverage Web site. formal, request, posting of the tracking information on unpublished evidence, We consider all the public comments sheet on our Web site facilitates the such as the results obtained by when developing a final NCD list for ability of interested individuals to individual practitioners or patients, are removal. When the final NCD list for participate in, and monitor, the progress less rigorous and therefore less useful removal is posted to our Coverage Web of our review. This is a key element in for making a coverage determination. site, we summarize the comments and making our NCD process more efficient, Public comments that contain briefly explain our rationale as to why open, and accessible to the public. personally identifiable health information are either redacted or not a specific NCD remained active, was We then undertake a formal evidence made available to the public. Comments removed from active national status, or review to determine whether or not an containing extensive personal health qualified for reconsideration. The final unbiased interpretation of the available information may leave no substantive list will be effective upon posting it to evidence base supports or refutes the comment after redaction. the Web site. requested coverage in whole or in part. We prefer to receive comments Currently, an existing NCD must We may also consider the need to obtain electronically; as these are more undergo a formal reconsideration additional input through technology efficiently reviewed, catalogued, and process to be removed or amended and assessments from an outside entity and/ redacted for personally identifiable the process generally takes 9 to 12 or deliberation by the Medicare health information. If a commenter months. We expect this new Evidence Development and Coverage chooses to submit comments through administrative procedure to reduce that Advisory Committee (MEDCAC). A more than one channel, duplicate time significantly. We believe that this formal review may result in an NCD, a submissions are treated as a single streamlined process is more efficient noncoverage NCD, or an NCD with comment. and helpful to the public because it limitations. We also may determine that In general, we avoid opening and instills confidence that national policies no NCD is required, permitting local closing public comment periods on are being monitored to ensure health Medicare contractors to make the initial federal holidays or weekends. We may benefits for Medicare beneficiaries determination under section 1862(a)(1) have limited ability to accommodate remain current. of the Act. this goal, however, under tight statutory We may consider an older NCD for deadlines. removal if, among other things, any of VI. Public Comment the following circumstances apply: We strive to conduct the NCD process VII. Prioritizing Requests • We believe that allowing local in an open and transparent manner with In the event that we have a large contractor discretion better serves the thoughtful consideration of public volume of NCD requests for needs of the Medicare program and its comment. We have found that public simultaneous review, we prioritize these beneficiaries. commenters may cite published clinical requests based on the magnitude of the • The technology is generally evidence, contribute insight, and give us potential impact on the Medicare acknowledged to be obsolete and is no useful information. We are particularly program and its beneficiaries and longer marketed. interested in comments that include staffing resources. • In the case of a noncoverage NCD new evidence we have not reviewed for based on the experimental status of an the proposed decision or in past VIII. Time Frames item or service, the item or service in considerations of the NCD. Comments We strive to complete NCD-related the NCD is no longer considered should be timely and pertinent to the activities in a timely and efficient experimental. NCD. We respond in detail to the public manner, often before statutory • The NCD has been superseded by comments on a proposed decision in the deadlines. We prepare an annual Report subsequent Medicare policy. final decision memorandum. to Congress that tracks our performance

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with respect to certain key steps in the party disclosure requirements. This ADDRESSES: The public should send process which is also posted on our document, however, does make comments to: CMS Privacy Officer, Web site. The following steps and time reference to information associated with Division of Privacy Policy, Privacy frames are used for new NCDs and for an existing information collection Policy and Compliance Group, Office of reconsiderations of existing NCDs: request. The information listed in E-Health Standards & Services, Offices • Upon acceptance of a complete section IV.B ‘‘What Constitutes a of Enterprise Management, CMS, Room formal request or upon the opening of Complete, Formal Request for a National S2–24–25, 7500 Security Boulevard, a CMS initiated review, we publish on Coverage Determination or a Complete, Baltimore, Maryland 21244–1850. our Web site a tracking sheet that Formal Request for Reconsideration’’ of Comments received will be available for provides public notice of the opening of this notice, was previously approved review at this location, by appointment, the NCD process. We generally allow a under OMB control number 0938–0776. during regular business hours, Monday 30-day public comment period on the We are currently seeking reinstatement through Friday from 9:00 a.m.–3:00 NCD review topic announced via the of the OMB control number and the p.m., Eastern Time zone. tracking sheet. We use the initial public information collection requirements. We comments to inform a proposed published the required 60-day notice on FOR FURTHER INFORMATION CONTACT: decision. As stated above, at our February 12, 2013 (78 FR 9927). The 60- Celeste Dade-Vinson, Division of discretion, we may announce a day comment period ended April 15, Privacy Policy, Privacy Policy and proposed decision concurrent with the 2013. We will announce the submission Compliance Group, Office of E-Health notice of opening. of the information collection request to Standards & Services, Offices of • A proposed decision is posted no OMB via the required 30-day notice. Enterprise Management, CMS, Mail stop later than 6 months after the posting of S2–26–17, 7500 Security Boulevard, the tracking sheet, unless a technology Authority: (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Baltimore, Maryland 21244–1850, Office assessment (TA) from an outside entity Assistance Program; No. 93.773 Medicare— Phone: 410–786–0854, Facsimile: 410– is commissioned, a clinical trial is Hospital Insurance Program; and No. 93.774, 786–1347, Email: Celeste.Dade- requested, or a meeting of the MEDCAC Medicare—Supplementary Medical [email protected]. is convened. Insurance Program) • In the event that a TA is Dated: May 17, 2013. SUPPLEMENTARY INFORMATION: The commissioned from an outside entity or Marilyn Tavenner, Computer Matching and Privacy a MEDCAC meeting is held and a Protection Act of 1988 (Public Law Administrator, Centers for Medicare & clinical trial is not requested, the Medicaid Services. (Pub. L.) 100–503), amended the Privacy proposed decision is posted no later Act (5 U.S.C. 552a) by describing the Approved: May 17, 2013. than 9 months following the posting of manner in which computer matching Kathleen Sebelius, the tracking sheet. involving Federal agencies could be • Upon the posting of the proposed Secretary, Department of Health and Human performed and adding certain Services. decision, there is a 30-day public protections for individuals applying for comment period during which time the [FR Doc. 2013–19060 Filed 8–2–13; 4:15 pm] and receiving Federal benefits. public is invited to comment on the BILLING CODE 4120–01–P Section 7201 of the Omnibus Budget substance of the proposed decision. • A final NCD is posted on our Web Reconciliation Act of 1990 (Pub. L. 101– site no later than 60 days following the DEPARTMENT OF HEALTH AND 508) further amended the Privacy Act close of the public comment period on HUMAN SERVICES regarding protections for such the proposed decision. individuals. The Privacy Act, as • With publication of the final Centers for Medicare & Medicaid amended, regulates the use of computer decision memorandum, the NCD is Services matching by Federal agencies when effective for claims with dates of service records in a system of records are Privacy Act of 1974; CMS Computer matched with other Federal, state, or beginning with the effective date of the Match No. 2013–02; HHS Computer NCD. The memorandum contains, local government records. It requires Match No. 1306; DoD–DMDC Match No. Federal agencies involved in computer among other materials, the analysis and 12 conclusions and also the NCD that matching programs to: becomes a part of the Medicare National AGENCY: Department of Health and 1. Negotiate written agreements with Coverage Determination Manual (Pub. Human Services (HHS), Centers for the other agencies participating in the 100–3) of the CMS Internet Only Medicare & Medicaid Services (CMS). matching programs; Manual. After enactment of section ACTION: Notice of Computer Matching 2. Obtain the Data Integrity Board 1862(l) of the Act, the effective date for Program (CMP). approval of the match agreements; the NCD is the same date as the publication date of the final decision SUMMARY: In accordance with the 3. Furnish detailed reports about memorandum. Therefore, we have requirements of the Privacy Act of 1974, matching programs to Congress and found it expedient and practical to as amended, this notice establishes a OMB; include the NCD that is included in the CMP that CMS plans to conduct with 4. Notify applicants and beneficiaries Medicare National Coverage the Department of Defense (DoD). that the records are subject to matching; Determination manual in the final DATES: Effective Dates: Comments are and, decision memoranda and to use that invited on all portions of this notice. Public comments are due 30 days after 5. Verify match findings before date as the effective date for Medicare reducing, suspending, terminating, or coverage and payment purposes. publication. The matching program will become effective no sooner than 40 days denying an individual’s benefits or IX. Collection of Information after the report of the matching program payments. Requirements is sent to OMB and Congress, or 30 days This matching program meets the This document does not impose any after publication in the Federal requirements of the Privacy Act of 1974, new reporting, recordkeeping or third- Register, whichever is later. as amended.

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Dated: July 31, 2013. receive continued military health care DEPARTMENT OF HEALTH AND Michelle Snyder, benefits. This disclosure will provide HUMAN SERVICES Chief Operating Officer, Centers for Medicare TMA with the information necessary to & Medicaid Services. meet the Congressional mandate Centers for Medicare & Medicaid Services CMS Computer Match No. 2013–02 outlined in legislative provisions in the NDAA listed above. HHS Computer Match No. 1306 Privacy Act of 1974; CMS Computer DoD–DMDC Match No. 12 Current law requires TMA to Match No. 2013–12; HHS Computer NAME: discontinue military health care benefits Match No. 1307; SSA Computer Match ‘‘Disclosure of Enrollment and to MHS beneficiaries who are Medicare No. 1097–1899 Eligibility Information for Military eligible when they become eligible for AGENCY: Centers for Medicare & Health System Beneficiaries Who are Medicare Part A unless they are Medicaid Services (CMS), Department Medicare Eligible’’ enrolled in Medicare Part B. In order for of Health and Human Services (HHS). TMA to meet the requirements of SECURITY CLASSIFICATION: current law, CMS agrees to disclose ACTION: Notice of Computer Matching Level Three Privacy Act Sensitive certain Part A and Part B enrollment Program (CMP). PARTICIPATING AGENCIES: data on this dual eligible population, SUMMARY: In accordance with the The Centers for Medicare & Medicaid which will be used to determine a requirements of the Privacy Act of 1974, Services (CMS); and Department of beneficiary’s eligibility for care under as amended, this notice announces the Defense (DoD), Defense Manpower Data CHAMPUS/TRICARE. DMDC will establishment of a CMP that CMS plans Center (DMDC) and the Office of the receive the results of the computer to conduct with the Social Security Assistant Secretary of Defense (Health match and provide the information to Administration (SSA). Affairs)/TRICARE Management Activity TMA for use in its matching program. DATES: Effective Dates: Comments are (TMA) invited on all portions of this notice. DESCRIPTION OF RECORDS TO BE USED IN THE AUTHORITY FOR CONDUCTING MATCHING Public comments are due 30 days after MATCHING PROGRAM: PROGRAM: publication. The matching program will Prior to 1991, Civilian Health and The matching program will be become effective no sooner than 40 days Medical Program of the Uniformed conducted with data maintained in the after the report of the matching program Services (CHAMPUS) entitlement DoD System of Records (SOR) identified is sent to the Office of Management and terminated when any individual became as DMDC 02 DoD, entitled ‘‘Defense Budget (OMB) and Congress, or 30 days eligible for Medicare Part A on a non- Enrollment Eligibility Reporting after publication in the Federal premium basis. The National Defense System,’’ at 77 FR 69807 (November 21, Register, whichever is later. Authorization Act(s) (NDAA) for Fiscal 2012) and the SOR identified as DHA ADDRESSES: The public should send Years (FYs) 1992 and 1993 (Pub. L. 102– 07, entitled ‘‘Military Health comments to: CMS Privacy Officer, 190) Section 704, provide for Information System (MHIS),’’ at 71 FR Division of Privacy Policy, Privacy reinstatement of CHAMPUS as second 16127 (March 30, 2006). The release of Policy and Compliance Group, Office of payer for beneficiaries entitled to the data for CMS is covered under the E-Health Standards & Services, Offices Medicare on the basis of disability/End ‘‘Enrollment Database,’’ System No. 09– of Enterprise Management, CMS, Room Stage Renal Disease (ESRD) only if they 70–0502 published at 73 FR 10249 S2–24–25, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. also enroll in Part B. (February 26, 2008). This CMP implements the Comments received will be available for information matching provisions of the INCLUSIVE DATES OF THE MATCH: review at this location, by appointment, NDAA, FY 2001 (Pub. L. 106–398) during regular business hours, Monday Sections 711 and 712; the NDAA, FY The matching program will become through Friday from 9:00 a.m.–3:00 1993 (Pub. L. 102–484) Section 705; and effective no sooner than 40 days after p.m., Eastern Time zone. the NDAA, FYs 1992 and 1993 (Pub. L. the report of the matching program is FOR FURTHER INFORMATION CONTACT: 102–190) Sections 704 and 713. sent to OMB and Congress, or 30 days Aaron Wesolowski, Director, Section 732 of the FY 1996 NDAA after publication in the Federal Verifications Policy & Operations (Pub. L. 104–106), directed the Register, whichever is later. The Branch, Division of Eligibility and administering Secretaries to develop a matching program will continue for 18 Enrollment Policy and Operations, mechanism for notifying beneficiaries of months from the effective date and may Center for Consumer Information and their ineligibility for CHAMPUS when be renewed for an additional 12 month Insurance Oversight, CMS, 7501 loss of eligibility is due to Medicare period as long as the statutory language Wisconsin Avenue, Bethesda, MD status (Part A only). for the match exists and other 20814, Office Phone: (301) 492–4416, PURPOSE(S) OF THE MATCHING PROGRAM: conditions are met. Facsimile: (443) 380–5531, email: The purpose of the Computer [FR Doc. 2013–19013 Filed 8–6–13; 8:45 am] [email protected]. Matching Agreement is to establish the BILLING CODE 4120–03–P SUPPLEMENTARY INFORMATION: The conditions, safeguards and procedures Computer Matching and Privacy under which CMS will disclose Protection Act of 1988 (Public Law Medicare enrollment information to the (Pub. L. 100–503), amended the Privacy DoD, DMDC, and Health Affairs/TMA. Act (5 U.S.C. 552a) by describing the The disclosure by CMS will provide manner in which computer matching TMA with the information necessary to involving Federal agencies could be determine if Military Health System performed and adding certain (MHS) beneficiaries (other than protections for individuals applying for dependents of active duty personnel), and receiving Federal benefits. Section who are Medicare eligible, are eligible to 7201 of the Omnibus Budget

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Reconciliation Act of 1990 (Pub. L. 101– Secretary of HHS to establish a program • Prisoner Update Processing System 508) further amended the Privacy Act for determining eligibility for certain (PUPS), SSA/OPB, 60–0269, 64 FR regarding protections for such Insurance Affordability Programs, 11076 (March 8, 1999), as amended 72 individuals. The Privacy Act, as certifications of Exemption, and FR 69723 (December 10, 2007) and 78 amended, regulates the use of computer authorize use of secure, electronic FR 40542 (July 5 2013); matching by Federal agencies when interfaces and an on-line system for the • Master Beneficiary Record, SSA/ records in a system of records (SOR) are verification of eligibility. ORSIS, 60–0090, 71 FR 1826 (January matched with other Federal, state, or PURPOSE(S) OF THE MATCHING PROGRAM: 11, 2006), as amended 72 FR 69723 local government records. It requires (December 10, 2007) and 78 FR 40542 The purpose of the Computer Federal agencies involved in computer (July 5, 2013); matching programs to: Matching Agreement (CMA) is to • establish the terms, conditions, Earnings Recording and Self- 1. Negotiate written agreements with Employment Income System, SSA/ the other agencies participating in the safeguards, and procedures under which SSA will disclose information to CMS OEEAS, 60–0059, 71 FR 1819 (January matching programs; 11, 2006), as amended 78 FR 40542 (July 2. Obtain the Data Integrity Board in connection with the administration of 5, 2013). approval of the match agreements; Insurance Affordability Programs under the ACA and its implementing 3. Furnish detailed reports about INCLUSIVE DATES OF THE MATCH: matching programs to Congress and regulations. SSA will provide data to OMB; CMS and CMS will use SSA data The CMP will become effective no 4. Notify applicants and beneficiaries needed to make initial Eligibility sooner than 40 days after the report of that the records are subject to matching; Determinations, eligibility the matching program is sent to OMB and, Redeterminations and Renewal and Congress, or 30 days after 5. Verify match findings before decisions, including appeal publication in the Federal Register, reducing, suspending, terminating, or determinations, for Insurance whichever is later. The matching denying an individual’s benefits or Affordability Programs and program will continue for 18 months payments. certifications of Exemption. Insurance from the effective date and may be This matching program meets the Affordability Programs include: extended for an additional 12 months requirements of the Privacy Act of 1974, 1. Qualified Health Plan through an thereafter, if certain conditions are met. as amended. Exchange established under the ACA, [FR Doc. 2013–19014 Filed 8–6–13; 8:45 am] Dated: July 31, 2013. 2. Advance payments of the premium BILLING CODE 4120–01–P tax credit and cost sharing reductions, Michelle Snyder, 3. Medicaid, Chief Operating Officer, Centers for Medicare 4. Children’s Health Insurance DEPARTMENT OF HEALTH AND & Medicaid Services. Program, and HUMAN SERVICES CMS Computer Match No. 2013–12 5. Basic Health Program. HHS Computer Match No. 1307 As set forth in the CMA, SSA will Administration for Children and SSA Computer Match No. 1097–1899 provide CMS the following information Families NAME: when relevant: (1) Social Security number (SSN) verifications, (2) a death Proposed Information Collection ‘‘Computer Matching Agreement indicator, (3) an indicator of a finding of Activity; Comment Request between the Department of Health and disability by SSA under title II of the Human Services, Centers for Medicare & Proposed Projects Social Security Act, (4) prisoner data, Medicaid Services and the Social (5) monthly and annual Social Security Title: Required Data Elements for Security Administration for benefit information under title II of the Paternity Establishment Affidavits. Determining Enrollment or Eligibility Social Security Act, (6) quarters of for Insurance Affordability Programs OMB No.: 0970–0171. coverage, and (7) confirmation that an under the Patient Protection and Description: Section 466(a)(5)(C)(iv) of allegation of citizenship is consistent Affordable Care Act’’. the Social Security Act (the Act) with SSA records. requires States to develop and use an SECURITY CLASSIFICATION: DESCRIPTION OF RECORDS TO BE USED IN THE affidavit for the voluntary Unclassified. MATCHING PROGRAM: acknowledgement of paternity. The affidavit for the voluntary PARTICIPATING AGENCIES: The matching program will be conducted with data maintained by acknowledgement of paternity must Department of Health and Human include the minimum requirements Services (HHS), Centers for Medicare & CMS in the Health Insurance Exchanges System (HIX), CMS System No. 09–70– specified by the Secretary under section Medicaid Services (CMS), and the 452(a)(7) of the Act. The affidavits will Social Security Administration (SSA). 0560, as amended, published at 78 FR 8538 (Feb. 6, 2013) and 78 FR 32256 be used by hospitals, birth record AUTHORITY FOR CONDUCTING MATCHING (May 29, 2013). agencies, and other entities participating PROGRAM: The matching program will also be in the voluntary paternity establishment Sections 1411 and 1413 of the Patient conducted with data maintained by SSA program. Protection and Affordable Care Act of in the following SORs: Respondents: State and Tribal IV–D 2010 (Pub. L. 111–148), as amended by • Master Files of SSN Holders and agencies, hospitals, birth record the Health Care and Education SSN Applications, SSA/OEEAS, 60– agencies and other entities participating Reconciliation Act of 2010 (Pub. L. 111– 0058, 75 FR 82121 (December 29, 2010), in the voluntary paternity establishment 152) (collectively, the ACA) require the as amended 78 FR 40542 (July 5, 2013); program.

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ANNUAL BURDEN ESTIMATES

Number of Average Instrument Number of responses per burden hours Total burden respondents respondent per response hours

None ...... 1,113,719 1 0.17 189,332.23

Estimated Total Annual Burden SUMMARY: The Food and Drug Toy Laser Products.’’ This draft Hours: 189,332.23. Administration (FDA) is announcing guidance is to inform manufacturers of In compliance with the requirements that a collection of information entitled laser products, FDA headquarters and of Section 506(c)(2)(A) of the Paperwork ‘‘Clinical Laboratory Improvement field personnel, and the public of the Reduction Act of 1995, the Amendments Waiver Applications’’ has Center for Devices and Radiological Administration for Children and been approved by the Office of Health’s (CDRH) proposed approach on Families is soliciting public comment Management and Budget (OMB) under the safety of toy laser products. This on the specific aspects of the the Paperwork Reduction Act of 1995. draft guidance is not final nor is it in information collection described above. FOR FURTHER INFORMATION CONTACT: effect at this time. Comments may be forwarded by writing Daniel Gittleson, Office of Information DATES: Although you can comment on to the Administration for Children and Management, Food and Drug any guidance at any time (see 21 CFR Families, Office of Planning, Research Administration, 1350 Piccard Dr., PI50– 10.115(g)(5)), to ensure that the Agency and Evaluation, 370 L’Enfant 400B, Rockville, MD 20850, 301–796– considers your comment on this draft Promenade SW., Washington, DC 20447, 5156, [email protected]. guidance before it begins work on the Attn: ACF Reports Clearance Officer. SUPPLEMENTARY INFORMATION: On April final version of the guidance, submit Email address: 23, 2013, the Agency submitted a either electronic or written comments [email protected]. All requests proposed collection of information on the draft guidance by November 5, should be identified by the title of the entitled ‘‘Clinical Laboratory 2013. information collection. The Department specifically requests Improvement Amendments Waiver ADDRESSES: Submit written requests for comments on: (a) Whether the proposed Applications’’ to OMB for review and single copies of the draft guidance collection of information is necessary clearance under 44 U.S.C. 3507. An document entitled ‘‘Minimizing Risk for for the proper performance of the Agency may not conduct or sponsor, Children’s Toy Laser Products’’ to the functions of the agency, including and a person is not required to respond Division of Small Manufacturers, whether the information shall have to, a collection of information unless it International and Consumer Assistance, practical utility; (b) the accuracy of the displays a currently valid OMB control Center for Devices and Radiological agency’s estimate of the burden of the number. OMB has now approved the Health, Food and Drug Administration, proposed collection of information; (c) information collection and has assigned 10903 New Hampshire Ave., Bldg. 66, the quality, utility, and clarity of the OMB control number 0910–0598. The rm. 4613, Silver Spring, MD 20993– information to be collected; and (d) approval expires on July 31, 2016. A 0002. Send one self-addressed adhesive ways to minimize the burden of the copy of the supporting statement for this label to assist that office in processing collection of information on information collection is available on your request, or fax your request to 301– respondents, including through the use the Internet at http://www.reginfo.gov/ 847–8149. See the SUPPLEMENTARY of automated collection techniques or public/do/PRAMain. INFORMATION section for information on other forms of information technology. Dated: August 1, 2013. electronic access to the guidance. Consideration will be given to Leslie Kux, Submit electronic comments on the comments and suggestions submitted Assistant Commissioner for Policy. draft guidance to http:// www.regulations.gov. Submit written within 60 days of this publication. [FR Doc. 2013–19053 Filed 8–6–13; 8:45 am] comments to the Division of Dockets Robert Sargis, BILLING CODE 4160–01–P Management (HFA–305), Food and Drug Reports Clearance Officer. Administration, 5630 Fishers Lane, rm. [FR Doc. 2013–19058 Filed 8–6–13; 8:45 am] DEPARTMENT OF HEALTH AND 1061, Rockville, MD 20852. Identify BILLING CODE 4184–01–P HUMAN SERVICES comments with the docket number found in brackets in the heading of this Food and Drug Administration document. DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2012–D–1092] HUMAN SERVICES Robert J. Doyle, Center for Devices and Food and Drug Administration Minimizing Risk for Children’s Toy Radiological Health, Food and Drug Laser Products; Draft Guidance for Administration, 10903 New Hampshire [Docket No. FDA–2012–N–0937] Industry and Food and Drug Ave., Bldg. 66, Rm. 4672, Silver Spring, MD 20993–0002, 301–796–5863. Agency Information Collection Administration Staff; Availability I. Background Activities; Announcement of Office of AGENCY: Food and Drug Administration, Management and Budget Approval; HHS. This draft guidance is to inform Clinical Laboratory Improvement ACTION: Notice. manufacturers of laser products, FDA Amendments Waiver Applications headquarters and field personnel, and AGENCY: Food and Drug Administration, SUMMARY: The Food and Drug the public of CDRH’s proposed HHS. Administration (FDA) is announcing the approach on the safety of children’s toy availability of the draft guidance laser products. Lasers with outputs ACTION: Notice. entitled ‘‘Minimizing Risk for Children’s above certain levels that are operated in

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an unsafe and uncontrolled manner may Reduction Act of 1995 (44 U.S.C. 3501– ADDRESSES: Submit written requests for cause injury to the user and/or others 3520). The collection of information in single copies of this guidance to the within range of the laser beam. This is 21 CFR part 1040 is approved under Division of Drug Information, Center for a particular concern for lasers intended OMB control number 0910–0025. Drug Evaluation and Research, Food for entertainment purposes, especially and Drug Administration, 10903 New V. Comments when intended to be used as toys by Hampshire Ave., Bldg. 51, Rm. 2201, children. Although Federal law requires Interested persons may submit either Silver Spring, MD 20993–0002; the all laser products sold in the United electronic comments regarding this Office of Communication, Outreach and States to be in compliance with the document to http://www.regulations.gov Development (HFM–40), Center for Federal Performance Standards for Laser or written comments regarding this Biologics Evaluation and Research, Products (21 CFR 1040.10 and 1040.11), document to the Division of Dockets Food and Drug Administration, 1401 at present FDA regulations do not Management (see ADDRESSES). It is only Rockville Pike, suite 200N, Rockville, specifically address children’s toy laser necessary to send one set of comments. MD 20852–1448; or the Office of products. FDA recently issued a Identify comments with the docket Communication and Education, proposed rule (78 FR 37723) that number found in brackets in the Division of Small Manufacturers, proposes to define children’s toy laser heading of this document. Received International and Consumer Assistance, products and require them to be within comments may be seen in the Division Center for Devices and Radiological International Electrotechnical of Dockets Management between 9 a.m. Health, Food and Drug Administration, Commission (IEC) Class 1 emission and 4 p.m., Monday through Friday, and 10903 New Hampshire Ave., Bldg. 66, limits. While this rulemaking process is will be posted to the docket at http:// Rm. 4613, Silver Spring, MD 20993– ongoing, CDRH encourages www.regulations.gov. 0002. Send one self-addressed adhesive manufacturers to keep children’s toy Dated: August 1, 2013. label to assist that office in processing laser products within IEC Class 1 Leslie Kux, your requests. See the SUPPLEMENTARY emission limits in order to minimize the INFORMATION Assistant Commissioner for Policy. section for electronic risk they pose to this vulnerable access to the guidance document. population. [FR Doc. 2013–19018 Filed 8–6–13; 8:45 am] Submit electronic comments on the BILLING CODE 4160–01–P II. Significance of Guidance guidance to http://www.regulations.gov. Submit written comments to the This draft guidance is being issued Division of Dockets Management (HFA– consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND HUMAN SERVICES 305), Food and Drug Administration, practices regulation (21 CFR 10.115). 5630 Fishers Lane, Rm. 1061, Rockville, The draft guidance represents the MD 20852. Agency’s proposed approach on Food and Drug Administration FOR FURTHER INFORMATION CONTACT: Ann children’s toys that are or that contain Meeker-O’Connell, Center for Drug laser products. It does not create or [Docket No. FDA–2011–D–0597] Evaluation and Research, Food and confer any rights for or on any person Drug Administration, 10903 New and does not operate to bind FDA or the Guidance for Industry on Oversight of Hampshire Ave., Bldg. 51, rm. 5356, public. An alternative approach may be Clinical Investigations—A Risk-Based Silver Spring, MD 20993–0002, 301– used if such approach satisfies the Approach to Monitoring; Availability 796–7615; or Stephen Ripley, Center for requirements of the applicable statute AGENCY: Food and Drug Administration, Biologics Evaluation and Research and regulations. HHS. (HFM–17), Food and Drug III. Electronic Access ACTION: Notice. Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, Persons interested in obtaining a copy SUMMARY: The Food and Drug of the draft guidance may do so by using 301–827–6210; or Linda Godfrey, Center Administration (FDA) is announcing the for Devices and Radiological Health, the Internet. To receive ‘‘Minimizing availability of a guidance for industry Risk for Children’s Toy Laser Products,’’ Food and Drug Administration, 10903 entitled ‘‘Oversight of Clinical New Hampshire Ave., Bldg. 66, Rm. you may either send an email request to Investigations—A Risk-Based Approach [email protected] to receive an 3446, Silver Spring, MD 20993–0002, to Monitoring.’’ This guidance assists 301–796–5490. electronic copy of the document or send sponsors in developing risk-based SUPPLEMENTARY INFORMATION: a fax request to 301–847–8149 to receive monitoring strategies and plans for a hard copy. Please use the document clinical investigations of human drugs, I. Background number 1810 to identify the guidance biologics, medical devices, and FDA is announcing the availability of you are requesting. A search capability combinations thereof. The overarching for all CDRH guidance documents is a guidance for industry entitled goal of this guidance is to enhance ‘‘Oversight of Clinical Investigations—A available at http://www.fda.gov/ human subject protection and the MedicalDevices/ Risk-Based Approach to Monitoring.’’ quality of clinical trial data by focusing FDA is publishing this guidance to DeviceRegulationandGuidance/ sponsor oversight on the most important GuidanceDocuments/default.htm. assist sponsors of clinical investigations aspects of study conduct and reporting. in developing risk-based monitoring Guidance documents are also available The guidance makes clear that sponsors at http://www.regulations.gov. strategies and plans for clinical can use a variety of approaches to meet investigations of human drug and IV. Paperwork Reduction Act of 1995 their responsibilities for monitoring biological products, medical devices, This draft guidance refers to a investigational new drug or and combinations thereof. This currently approved collection of investigational device exemption guidance is intended to make clear that information found in FDA regulations. studies. sponsors can use a variety of approaches This collection of information is subject DATES: Submit either electronic or to meet their responsibilities for to review by the Office of Management written comments on Agency guidances monitoring clinical investigations under and Budget (OMB) under the Paperwork at any time. 21 CFR parts 312 and 812.

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In the Federal Register of August 29, IV. Electronic Access 796–9001, FAX: 301–847–8533, email: 2011 (76 FR 53683), FDA announced the Persons with access to the Internet [email protected], or FDA Advisory availability of the draft guidance may obtain the document at either Committee Information Line, 1–800– entitled ‘‘Oversight of Clinical http://www.fda.gov/Drugs/ 741–8138 (301–443–0572 in the Investigations: A Risk-Based Approach GuidanceCompliance Washington, DC area). A notice in the to Monitoring,’’ dated August 2011, and RegulatoryInformation/Guidances/ Federal Register about last minute the public was provided with an default.htm, http://www.fda.gov/ modifications that impact a previously opportunity to comment on it until BiologicsBloodVaccines/Guidance announced advisory committee meeting November 28, 2011. FDA carefully ComplianceREgulatoryInformation/ cannot always be published quickly enough to provide timely notice. considered all of the comments received default.htm, http://www.fda.gov/ in developing the final guidance. The Therefore, you should always check the MedicalDevices/DeviceRegulation final guidance includes clarifications Agency’s Web site at http:// andGuidance/GuidanceDocuments/ and additional detail on some topics. www.fda.gov/AdvisoryCommittees/ default.htm, or http:// For example, the final guidance default.htm and scroll down to the www.regulations.gov. includes additional detail on how to appropriate advisory committee meeting perform risk-based monitoring and Dated: August 1, 2013. link, or call the advisory committee examples of monitoring techniques. Leslie Kux, information line to learn about possible The final guidance describes Assistant Commissioner for Policy. modifications before coming to the strategies for monitoring activities that [FR Doc. 2013–19004 Filed 8–6–13; 8:45 am] meeting. reflect a modern, risk-based approach BILLING CODE 4160–01–P Agenda: The purpose of the meeting that focuses on critical study parameters on October 17, 2013, is to discuss and relies on a combination of susceptibility interpretive criteria for monitoring activities to oversee a study DEPARTMENT OF HEALTH AND systemic antibacterial drugs and for effectively. The guidance also makes HUMAN SERVICES dosing recommendations in product recommendations about how to develop labeling. We will seek input on the role monitoring plans and document Food and Drug Administration of pharmacokinetic data in setting susceptibility interpretive criteria. We monitoring activities and includes [Docket No. FDA–2013–N–0001] additional strategies to ensure study will also discuss revising dosing quality. Anti-Infective Drugs Advisory recommendations in product labeling This guidance is being issued Committee; Notice of Meeting based on pharmacokinetic data and consistent with FDA’s good guidance clinical safety and efficacy data. practices regulation (21 CFR 10.115). AGENCY: Food and Drug Administration, FDA intends to make background The guidance represents the Agency’s HHS. material available to the public no later current thinking on oversight of clinical ACTION: Notice. than 2 business days before the meeting. investigations—a risk-based approach to If FDA is unable to post the background monitoring. It does not create or confer This notice announces a forthcoming material on its Web site prior to the any rights for or on any person and does meeting of a public advisory committee meeting, the background material will not operate to bind FDA or the public. of the Food and Drug Administration be made publicly available at the An alternative approach may be used if (FDA). The meeting will be open to the location of the advisory committee such approach satisfies the public. meeting, and the background material requirements of the applicable statutes Name of Committee: Anti-Infective will be posted on FDA’s Web site after and regulations. Drugs Advisory Committee. the meeting. Background material is General Function of the Committee: available at http://www.fda.gov/ II. Paperwork Reduction Act of 1995 To provide advice and AdvisoryCommittees/Calendar/ This guidance contains information recommendations to the Agency on default.htm. Scroll down to the collection provisions that are subject to FDA’s regulatory issues. appropriate advisory committee meeting review by the Office of Management and Date and Time: The meeting will be link. Budget (OMB) under the Paperwork held on October 17, 2013, from 8 a.m. Procedure: Interested persons may Reduction Act of 1995 (44 U.S.C. 3501– to 5 p.m. present data, information, or views, 3520). The collections of information in Location: FDA White Oak Campus, orally or in writing, on issues pending this guidance were approved under Building 31, the Great Room, White Oak before the committee. Written OMB control numbers 0910–0078, Conference Center (Rm. 1503), 10903 submissions may be made to the contact 0910–0014, and 0910–0733. New Hampshire Ave., Silver Spring, MD person on or before October 2, 2013. 20993–0002. Information regarding Oral presentations from the public will III. Comments special accommodations due to a be scheduled between approximately 1 Interested persons may submit either disability, visitor parking, and p.m. and 2:30 p.m. Those individuals electronic comments regarding this transportation may be accessed at: interested in making formal oral document to http://www.regulations.gov http://www.fda.gov/ presentations should notify the contact or written comments to the Division of AdvisoryCommittees/default.htm; under person and submit a brief statement of Dockets Management (see ADDRESSES). It the heading ‘‘Resources for You,’’ click the general nature of the evidence or is only necessary to send one set of on ‘‘Public Meetings at the FDA White arguments they wish to present, the comments. Identify comments with the Oak Campus.’’ Please note that visitors names and addresses of proposed docket number found in brackets in the to the White Oak Campus must enter participants, and an indication of the heading of this document. Received through Building 1. approximate time requested to make comments may be seen in the Division Contact Person: Diane Goyette, Center their presentation on or before of Dockets Management between 9 a.m. for Drug Evaluation and Research, Food September 24, 2013. Time allotted for and 4 p.m., Monday through Friday, and and Drug Administration, 10903 New each presentation may be limited. If the will be posted to the docket at http:// Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to www.regulations.gov. Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably

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accommodated during the scheduled This notice describes CDER’s initiative, that input before issuing final versions open public hearing session, FDA may announces the first group of guidances of the guidances. In many cases, conduct a lottery to determine the to be withdrawn, describes in general guidances were not finalized most often speakers for the scheduled open public terms draft guidances under because of higher staff priorities. hearing session. The contact person will consideration for revision or However, over the years, because of new notify interested persons regarding their finalization, and explains how CDER is information, scientific developments, request to speak by September 25, 2013. making this process as transparent as and emerging technologies, draft Persons attending FDA’s advisory possible. guidances were also revised, and committee meetings are advised that the 1 DATES: General comments on Agency reissued or withdrawn. Agency is not responsible for providing guidance documents are welcome at any Recently, CDER launched an initiative access to electrical outlets. time. to review draft guidance documents FDA welcomes the attendance of the published before 2010 to decide which ADDRESSES: Submit electronic public at its advisory committee guidances to withdraw, revise, or comments on Agency guidance meetings and will make every effort to finalize with only minor changes. CDER documents to http:// accommodate persons with physical is withdrawing draft guidances that are www.regulations.gov. Submit written disabilities or special needs. If you no longer up to date. CDER is also comments to the Division of Dockets require special accommodations due to actively reviewing the draft guidances to Management (HFA–305), Food and Drug a disability, please contact Diane determine which ones to either revise or Administration, 5630 Fishers Lane, Rm. Goyette at least 7 days in advance of the finalize. This notice lists the first group 1061, Rockville, MD 20852. See the meeting. of guidances CDER has identified for SUPPLEMENTARY INFORMATION section for FDA is committed to the orderly withdrawal, describes generally what electronic access to Agency guidance conduct of its advisory committee guidances are being reviewed, and documents. meetings. Please visit our Web site at describes how CDER will keep the http://www.fda.gov/ FOR FURTHER INFORMATION CONTACT: public informed of the guidances that AdvisoryCommittees/ Kimberly K. Thomas, Center for Drug are available with the goal of making the AboutAdvisoryCommittees/ Evaluation and Research, Food and initiative transparent and consistent ucm111462.htm for procedures on Drug Administration, 10903 New with the GGP regulation (21 CFR public conduct during advisory Hampshire Ave., Bldg. 51, Rm. 6220, 10.115). committee meetings. Silver Spring, MD 20993–0002, 301– Notice of this meeting is given under 796–2357, II. Withdrawal of Guidances the Federal Advisory Committee Act (5 [email protected]. CDER has reviewed many draft U.S.C. app. 2). SUPPLEMENTARY INFORMATION: guidances published before 2010. As a Dated: August 1, 2013. result of this review, CDER identified 23 Jill Hartzler Warner, I. Background draft guidances for withdrawal. The Acting Associate Commissioner for Special In September 2000, FDA issued the guidances are being withdrawn because Medical Programs. final rule ‘‘Administrative Practices and they are out of date, thus of little use to [FR Doc. 2013–19036 Filed 8–6–13; 8:45 am] Procedures; Good Guidance Practices’’ the pharmaceutical industry. In most BILLING CODE 4160–01–P (GGP) (65 FR 56468; September 19, cases, FDA has developed other 2000). The GGP regulation describes guidances and resources to assist FDA policies and procedures for the industry with clinical evaluation and DEPARTMENT OF HEALTH AND development, issuance, and use of requirements for drug approval. The HUMAN SERVICES guidance documents and makes these guidances identified for withdrawal Agency policies and procedures clear to relate to these topics: Food and Drug Administration the public. The GGP regulation provides • Current good manufacturing [Docket No. FDA–2013–N–0779] for developing and issuing guidances practice (cGMP) compliance specific to that set forth initial interpretations of manufacturing, processing, and dose Retrospective Review of Draft statutory or regulatory requirements, unit sampling and assessment; Guidance Documents Issued Before explain changes in interpretation of • Development of antimicrobial drugs 2010; Withdrawal of Guidances policies that are of other than minor in for the treatment of acute bronchitis, AGENCY: Food and Drug Administration, nature, or discuss complex scientific bacterial meningitis, bacterial HHS. issues or highly controversial issues. prostatitis, bacterial vaginosis, catheter- related bloodstream infections, febrile ACTION: Notice. The GGP regulation also requires that such guidances be issued in draft for neutropenia, gonorrhea, Lyme disease, SUMMARY: The Food and Drug public comment before they are streptococcal pharyngitis and tonsillitis, Administration (FDA) is announcing an finalized (Level 1 guidances). In uncomplicated urinary tract infections, initiative in the Center for Drug addition, the GGP regulation explains and vuvlovaginal candidiasis; Evaluation and Research (CDER) that FDA will periodically review • Clinical trials for developing involving the review of draft guidance existing guidance documents to antimicrobial drugs and packaging of documents issued before 2010 to determine whether they need to be determine their status, and to decide changed or withdrawn. 1 When Level 1 guidances are revised, they are whether those guidances should be A key component of the GGP usually issued as draft, version 2s, for public input before being issued in final form. When a guidance withdrawn, revised, or finalized with regulation is ensuring transparency needs to be withdrawn, a notice is sometimes only minor changes. Guidances that are during guidance development and published in the Federal Register announcing that no longer up to date, and for which issuance. Since finalization of the GGP the guidance has been withdrawn. If no withdrawal more current information is available, regulation in September 2000, CDER has announcement is made, CDER maintains a current list of new/revised/withdrawn guidances on the will be withdrawn. Guidances that issued an average of approximately 20 CDER guidance Web page at http://www.fda.gov/ reflect CDER’s current thinking, CDER draft guidances each year, seeking Drugs/GuidanceComplianceRegulatoryInformation/ will decide whether to revise or finalize. public input and carefully considering Guidances/default.htm.

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inhalation products in semipermeable 12. ‘‘Vulvovaginal Candidiasis— identified guidances for revision or container systems; Developing Antimicrobial Drugs for finalization. CDER is in the process of • Approval of abbreviated new drug Treatment’’—issued July 1998. developing a plan for their completion. applications (ANDAs) and 505(b)(2) 13. ‘‘Bacterial Vaginosis—Developing Guidances for revision or finalization applications under the Drug Price Antimicrobial Drugs for Treatment’’— are specific to the following topics: Competition and Patent Term issued July 1998. • Biopharmaceutics; Restoration Act of 1984 (i.e., the Hatch- 14. ‘‘Acute Bacterial Meningitis— • Chemistry, manufacturing, and Waxman Act); Developing Antimicrobial Drugs for controls; • Treatment’’—issued July 1998. Procedures relating to submission • Clinical pharmacology; of patent information, submission of 15. ‘‘Acute or Chronic Bacterial • Combination products; marketing applications, and forms for Prostatitis—Developing Antimicrobial • registration and disclosure of Drugs for Treatment’’—issued July cGMP compliance; information; 1998. • Development of antimicrobial • Labeling in ANDAs; and 16. ‘‘Developing Antimicrobial Drugs— drugs; • Qualifying for pediatric exclusivity General Considerations for Clinical • Drug advertisements; under the Best Pharmaceuticals for Trials’’—issued July 1998. • Drug safety; Children Act. 17. ‘‘Catheter-Related Bloodstream • Electronic submissions; CDER is withdrawing the following Infections—Developing Antimicrobial • Drugs for Treatment’’—issued October Labeling; guidances: • 1999. OTC products; 1. ‘‘Manufacturing, Processing, or • For information on the preceding 13 Pharmacology and toxicology; Holding Active Pharmaceutical • Ingredients’’—issued April 1998. guidances (number 5 through 17), Procedural guidances; and • 2. ‘‘Powder Blends and Finished Dosage contact the Office of Antimicrobial Radiopharmaceuticals. Products in the Office of New Drugs in Units—Stratified In-Process Dosage IV. Maintaining Transparency Unit Sampling and Assessment’’— CDER. issued November 2003. 18. ‘‘Labeling Over-the-Counter (OTC) CDER would like to make this process 3. ‘‘Forms for Registration of Producers Human Drug Products—Updating as transparent as possible, consistent of Drugs and Listing of Drugs in Labeling in ANDAs’’—issued with the GGP regulation. As a result, Commercial Distribution’’—issued February 2001. CDER is issuing this notice announcing May 2001. For information on the preceding the initiative for draft guidance review, 4. ‘‘Disclosing Information Provided to guidance (number 18), contact the and listing the first group of guidances Advisory Committees in Connection Office of Drug Evaluation IV in the for withdrawal. CDER also maintains With Open Advisory Committee Office of New Drugs in CDER. and regularly updates on its guidance Web site a list of new, revised, and Meetings Related to the Testing or 19. ‘‘Inhalation Drug Products Packaged withdrawn guidances (at http:// Approval of New Drugs and in Semipermeable Container Closure www.fda.gov/Drugs/ Convened by CDER, Beginning on Systems’’—issued July 2002. GuidanceCompliance January 1, 2000’’—issued December 20. ‘‘Listed Drugs, 30-Month Stays, and RegulatoryInformation/Guidances/ 1999. ANDAs and 505(b)(2) Applications default.htm). Each year CDER also Under Hatch-Waxman, as Amended For information on the four preceding publishes on its guidance Web site a by the Medicare Prescription Drug, guidances, contact the Office of Guidance Agenda, which lists new draft Improvement, and Modernization Act Compliance in CDER. and revised draft guidances planned for of 2003—Questions and Answers’’— 5. ‘‘Evaluating Clinical Studies of issuance in the given calendar year. issued November 2004. Antimicrobials in the Division of 21. ‘‘Referencing Discontinued Labeling V. Comments Anti-Infective Drug Products’’— for Listed Drugs in Abbreviated New issued February 1997. Drug Applications’’—issued October Interested persons may submit either 6. ‘‘Empiric Therapy of Febrile 2000. electronic comments regarding Agency Neutropenia—Developing 22. ‘‘Submission of Patent Information guidance documents to http:// Antimicrobial Drugs for Treatment’’— for Certain Old Antibiotics’’—issued www.regulations.gov or written issued July 1998. December 2008. comments to the Division of Dockets 7. ‘‘Lyme Disease—Developing Management (see ADDRESSES). It is only Antimicrobial Drugs for Treatment’’— For information on the preceding four necessary to send one set of comments. issued July 1998. guidances (number 19 through 22), Identify comments with the docket 8. ‘‘Secondary Bacterial Infections of contact the Office of Pharmaceutical number found in brackets in the Acute Bronchitis—Developing Science in CDER. heading of this document. Received Antimicrobial Drugs for Treatment’’— 23. ‘‘Qualifying for Pediatric Exclusivity comments may be seen in the Division issued July 1998. Under Section 505A of the Federal of Dockets Management between 9 a.m. 9. ‘‘Streptococcal Pharyngitis and Food, Drug, and Cosmetic Act’’— and 4 p.m., Monday through Friday, and Tonsillitis—Developing Antimicrobial issued September 1999. will be posted to the docket at http:// Drugs for Treatment’’—issued July For information on the preceding www.regulations.gov. 1998. guidance (number 23), contact the VI. Electronic Access 10. ‘‘Uncomplicated Gonorrhea— Pediatric and Maternal Health Staff in Developing Antimicrobial Drugs for the Office of New Drugs in CDER. Persons with access to the Internet Treatment’’—issued July 1998. may obtain CDER guidance documents 11. ‘‘Uncomplicated Urinary Tract III. Revision or Finalization of at http://www.fda.gov/Drugs/ Infections—Developing Antimicrobial Guidances GuidanceCompliance Drugs for Treatment’’—issued July In addition to identifying the first set RegulatoryInformation/Guidances/ 1998. of guidances for withdrawal, CDER also default.htm.

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Dated: August 2, 2013. ceased shipment of original OxyContin, and Budget (OMB) a request for review Leslie Kux, and FDA subsequently moved original and approval of the information Assistant Commissioner for Policy. OxyContin to the ‘‘Discontinued Drug collection listed below. This proposed [FR Doc. 2013–19051 Filed 8–6–13; 8:45 am] Product List’’ section of the Orange information collection was previously BILLING CODE 4160–01–P Book. In a letter to FDA dated March 19, published in the Federal Register on 2013, Purdue requested that FDA May 28, 2013, Volume 78, Number 102, withdraw approval of NDA 20–553 for Pages 31947–31948 and allowed 60- DEPARTMENT OF HEALTH AND original OxyContin, noting that the days for public comment. No comments HUMAN SERVICES original formulation of OxyContin was were received. The purpose of this subject to abuse and misuse, and that it notice is to allow an additional 30 days Food and Drug Administration was ‘‘not possible to develop labeling or for public comment. The National [Docket No. FDA–2013–N–0883] REMS provisions that would create a Institute of Mental Health (NIMH), positive risk/benefit ratio for the National Institutes of Health, may not Purdue Pharma L.P.; Withdrawal of original formulation of OxyContin.’’ In conduct or sponsor, and the respondent Approval of a New Drug Application for that letter, Purdue waived its right to a is not required to respond to, an Oxycontin hearing. information collection that has been On April 18, 2013, FDA published extended, revised, or implemented on or AGENCY: Food and Drug Administration, notice of its determination that original after October 1, 1995, unless it displays HHS. OxyContin, NDA 20–553, was a currently valid OMB control number. ACTION: Notice. withdrawn from sale for reasons of Direct Comments to OMB: Written safety or effectiveness (78 FR 23273). SUMMARY: The Food and Drug comments and/or suggestions regarding Administration (FDA) is withdrawing The notice concluded that ‘‘[o]riginal the item(s) contained in this notice, approval of a new drug application OxyContin . . . poses an increased especially regarding the estimated (NDA) for OXYCONTIN (oxycodone potential for abuse by certain routes of public burden and associated response hydrochloride) Extended-Release administration, when compared to time, should be directed to the: Office Tablets, held by Purdue Pharma L.P. reformulated OxyContin. Based on the of Management and Budget, Office of (Purdue), One Stamford Forum, totality of the data and information Regulatory Affairs, _ Stamford, CT 06901–3431. Purdue has available to the Agency at this time, OIRA [email protected] or by voluntarily requested that approval of FDA concludes that the benefits of fax to 202–395–6974, Attention: NIH this application (NDA 20–553) be original OxyContin no longer outweigh Desk Officer. withdrawn and has waived its its risks.’’ DATES: Comment Due Date: Comments opportunity for a hearing. Under section 505(e) of the Federal regarding this information collection are Food, Drug, and Cosmetic Act (the DATES: Effective August 7, 2013. best assured of having their full effect if FD&C Act) (21 U.S.C. 355(e)), and under FOR FURTHER INFORMATION CONTACT: received within 30 days of the date of authority delegated by the this publication. Patrick Raulerson, Center for Drug Commissioner to the Director, Center for FOR FURTHER INFORMATION CONTACT: To Evaluation and Research, Food and Drug Evaluation and Research, approval obtain a copy of the data collection Drug Administration, 10903 New of NDA 20–553, and all amendments plans and instruments, or request more Hampshire Ave., Bldg. 51, rm. 6368, and supplements thereto, is withdrawn Silver Spring, MD 20993–0002, 301– information on the proposed project, (see DATES). Distribution of this product contact: Keisha Shropshire, NIMH 796–3522. in interstate commerce without an Project Clearance Liaison, Science SUPPLEMENTARY INFORMATION: FDA approved application is illegal and Policy and Evaluation Branch, OSPPC, approved NDA 20–553 for OXYCONTIN subject to regulatory action (see sections NIMH, NIH, Neuroscience Center, 6001 (oxycodone hydrochloride) Extended- 505(a) and 301(d) of the FD&C Act (21 Executive Boulevard, MSC 9667, Release Tablets, 10 milligrams (mg), 15 U.S.C. 355(a) and 331(d)). mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, Rockville Pike, Bethesda, MD 20892, or and 160 mg, (original OxyContin), on Dated: July 30, 2013. call 301–443–4335 or email your December 12, 1995. A reformulated Janet Woodcock, request, including your address to: version of these products, OXYCONTIN Director, Center for Drug Evaluation and [email protected]. Formal requests (oxycodone hydrochloride) Extended- Research. for additional plans and instruments Release Tablets, 10 mg, 15 mg, 20 mg, [FR Doc. 2013–18694 Filed 8–6–13; 8:45 am] must be requested in writing. 30 mg, 40 mg, 60 mg, and 80 mg BILLING CODE 4160–01–P Proposed Collection: The National (reformulated OxyContin), is the subject Institute of Mental Health Data Access of NDA 22–272, also held by Purdue Request and Use Certification and initially approved on April 5, 2010. DEPARTMENT OF HEALTH AND (previously National Database for Reformulated OxyContin was developed HUMAN SERVICES Autism Research Data Access Request), with physicochemical properties that 0925–0667, Revision, Expiration Date: National Institutes of Health are intended to make the tablet more 01/31/2016; National Institute of Mental difficult to manipulate for purposes of Submission for OMB Review; 30-day Health (NIMH), National Institutes of abuse or misuse. Both original and Comment Request: National Institute Health (NIH). reformulated OxyContin are opioid of Mental Health Data Access Request Need and Use of Information agonist products. Original OxyContin and Use Certification Collection: NIMH recently received was indicated for the management of OMB approval for use of the National moderate to severe pain when a SUMMARY: Under the provisions of Database for Autism Research (NDAR) continuous, around-the-clock opioid Section 3507(a)(1)(D) of the Paperwork Data Use Certification (DUC) Form. analgesic is needed for an extended Reduction Act of 1995, the National NIMH is interested in renaming this period of time. Institute of Mental Health (NIMH), the form the ‘‘NIMH Data Access Request In correspondence dated August 10, National Institutes of Health, has and Use Certification (DUC) Form’’ and 2010, Purdue notified FDA that it had submitted to the Office of Management using it to meet the unique data access

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needs of all NIMH data repositories. The information is to document, track, (PedsMRI), and the NIMH Clinical NIMH DUC form is necessary for monitor, and evaluate the use of the Research Datasets (NCRD). ‘‘Recipient’’ Principal Investigators and NIMH repositories/datasets, as well as OMB approval is requested for 3 their organization or corporations with to notify interested recipients of years. There are no costs to respondents approved assurance from the DHHS updates, corrections or other changes to other than their time. The total Office of Human Research Protections to the database. There are currently three estimated annualized burden hours are access data or images from NIMH data repositories/sets positioned to use 380. repositories and datasets for research the NIMH DUC form: NDAR, the NIH purposes. The primary use of this Pediatric MRI Data Repository

ESTIMATED ANNUALIZED BURDEN HOURS

Average time Form Type of respondent Number of Frequency of per response Annual hour respondents response (in hours) burden

NIMH Data Access Request and Principal Investigators/Research As- 240 1 95/60 380 Use Certification. sistant.

Dated: July 25, 2013. Tool on the IACC Web site. No or Email your request, including your Sue Murrin, comments that specifically addressed address to: Executive Officer, NIMH, NIH. cost and hour burden were received. [email protected]. [FR Doc. 2013–19072 Filed 8–6–13; 8:45 am] The purpose of this notice is to allow an Formal requests for additional plans and BILLING CODE 4140–01–P additional 30 days for public comment. instruments must be requested in The National Institute of Mental Health writing. (NIMH), National Institutes of Health, Proposed Collection: Autism DEPARTMENT OF HEALTH AND may not conduct or sponsor, and the Spectrum Disorder (ASD) Research HUMAN SERVICES respondent is not required to respond Portfolio Analysis, 0925—NEW- to, an information collection that has National Institute of Mental Health National Institutes of Health been extended, revised, or implemented (NIMH), National Institutes of Health on or after October 1, 1995, unless it (NIH). Submission for OMB Review; 30-day displays a currently valid OMB control Need and Use of Information Comment Request: Autism Spectrum number. Collection: The purpose of the ASD Disorder Research Portfolio Analysis Direct Comments to OMB: Written portfolio analysis is to collect research SUMMARY: Under the provisions of comments and/or suggestions regarding funding data from U.S. and Section 3507(a)(1)(D) of the Paperwork the item(s) contained in this notice, international ASD research funders, to Reduction Act of 1995, the National especially regarding the estimated assist the Interagency Autism Institute of Mental Health (NIMH), the public burden and associated response Coordinating Committee (IACC) in National Institutes of Health, has time, should be directed to the: Office fulfilling the requirements of the submitted to the Office of Management of Management and Budget, Office of Combating Autism Act, and to inform and Budget (OMB) a request for review Regulatory Affairs, the committee and interested and approval of the information [email protected] or by stakeholders of the funding landscape collection listed below. This proposed fax to 202–395–6974, Attention: NIH and current directions for ASD research. information collection was previously Desk Officer. Specifically, these analyses will published in the Federal Register on Comment Due Date: Comments examine the extent to which current May 24, 2013, Volume 78, Number 101, regarding this information collection are funding and research topics align with Pages 31568–31569 and allowed 60- best assured of having their full effect if the IACC Strategic Plan for ASD days for public comment. One public received within 30 days of the date of Research. The findings will help guide comment was received; in this this publication. future funding priorities by outlining comment, a request was made for access FOR FURTHER INFORMATION CONTACT: To current gaps and opportunities in ASD to any data that is collected on autism obtain a copy of the data collection research as well as serving to highlight projects that are funded. This comment plans and instruments, or request more annual activities and research progress. was considered, but it did not result in information on the proposed project, OMB approval is requested for three alteration to the data collection or data contact: The Office of Autism Research years. There are no costs to respondents management process because steps are Coordination, NIMH, NIH, Neuroscience other than their time. The total already in place to make the data Center, 6001 Executive Blvd., MSC estimated annualized burden hours are publicly accessible via an online Web 9663, Room 6184, Bethesda, MD 20892 419.

ESTIMATED ANNUALIZED BURDEN HOURS

Type of Number of Average time respondents Number of response per per response Total burden (funders) respondents respondent (in hours ) hours

U.S. Federal ...... 26 36 15/60 234 U.S. Private ...... 12 54 15/60 162 International Government ...... 4 14 15/60 14 International Private ...... 4 9 15/60 9

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Dated: July 26, 2013. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is Sue Murrin, HUMAN SERVICES hereby given of the following meetings. Executive Officer, NIMH, NIH. The meetings will be closed to the National Institutes of Health [FR Doc. 2013–19089 Filed 8–6–13; 8:45 am] public in accordance with the BILLING CODE 4140–01–P Eunice Kennedy Shriver National provisions set forth in sections Institute of Child Health and Human 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Development; Notice of Meeting as amended. The grant applications and DEPARTMENT OF HEALTH AND the discussions could disclose HUMAN SERVICES Pursuant to section 10(a) of the confidential trade secrets or commercial Federal Advisory Committee Act, as property such as patentable material, National Institutes of Health amended (5 U.S.C. App.), notice is and personal information concerning hereby given of a meeting of the individuals associated with the grant National Institute of Neurological National Advisory Board on Medical Disorders and Stroke; Notice of Closed Rehabilitation Research. applications, the disclosure of which Meeting The meeting will be open to the would constitute a clearly unwarranted public. Individuals planning to attend invasion of personal privacy. Pursuant to section 10(d) of the the teleconference may do so by calling Name of Committee: Center for Scientific Federal Advisory Committee Act, as the toll-free number, 866–692–3158 and Review Special Emphasis Panel; PAR Panel: amended (5 U.S.C. App.), notice is entering the passcode: 2868336. Biodemography of Aging. hereby given of the following meeting. Name of Committee: National Advisory Date: August 15, 2013. The meeting will be closed to the Board on Medical Rehabilitation Research. Time: 11:00 a.m. to 12:30 p.m. public in accordance with the Date: August 13, 2013. Agenda: To review and evaluate grant provisions set forth in sections Time: 4:00 p.m. to 5:00 p.m. applications. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Agenda: NICHD Director will discuss his Place: National Institutes of Health, 6701 response to the recommendations in the as amended. The grant applications and Rockledge Drive, Bethesda, MD 20892, report of the Blue Ribbon Panel for Medical (Telephone Conference Call). the discussions could disclose Rehabilitation Research at NIH. confidential trade secrets or commercial Place: National Institutes of Health, Contact Person: Suzanne Ryan, Ph.D., property such as patentable materials, Building 31, 31 Center Drive, Room 2A03, Scientific Review Officer, Center for and personal information concerning Bethesda, MD 20892–2425, (Telephone Scientific Review, National Institutes of individuals associated with the grant Conference Call). Health, 6701 Rockledge Drive, Room 3139, applications, the disclosure of which Contact Person: Ralph M. Nitkin, Ph.D., MSC 7770, Bethesda, MD 20892, (301) 435– would constitute a clearly unwarranted Director, B.S.C.D., Biological Sciences and 1712, [email protected]. Career Development, NCMRR, Eunice invasion of personal privacy. This notice is being published less than 15 Kennedy Shriver National Institute of Child days prior to the meeting due to the timing Health and Human Development, NIH, Name of Committee: National Institute of limitations imposed by the review and DHHS, 6100 Executive Boulevard, Room Neurological Disorders and Stroke Special funding cycle. Emphasis Panel; Review Career Development 2A03, Bethesda, MD 20892–7510, (301) 402– 4206, [email protected]. Name of Committee: Center for Scientific Awards. Review Special Emphasis Panel Member Date: August 14, 2013. This notice is being published less than 15 days prior to the meeting due to the need to Conflict: Cardiovascular Sciences. Time: 2:00 p.m. to 3:00 p.m. Date: September 4–5, 2013. Agenda: To review and evaluate grant coordinate the availability of the Board membership to participate with the Institute Time: 8:00 a.m. to 5:00 p.m. applications. in reviewing the proposed response to the Agenda: To review and evaluate grant Place: National Institutes of Health, recommendations in the report of the Blue applications. Neuroscience Center, 6001 Executive Blvd., Ribbon Panel on Medical Rehabilitation Place: National Institutes of Health, 6701 Rockville, MD 20852 (Telephone Conference Research at NIH. Rockledge Drive, Bethesda, MD 20892, Call). (Catalogue of Federal Domestic Assistance Contact Person: Raul A. Saavedra, Ph.D., (Virtual Meeting). Program Nos. 93.864, Population Research; Contact Person: Kimm Hamann, Ph.D., Scientific Review Officer, Scientific Review 93.865, Research for Mothers and Children; Scientific Review Officer, Center for Branch, Division of Extramural Research, 93.929, Center for Medical Rehabilitation NINDS, NIH, NSC, 6001 Executive Blvd., Research; 93.209, Contraception and Scientific Review, National Institutes of Suite 3208, MSC 9529, Bethesda, MD 20892– Infertility Loan Repayment Program, National Health, 6701 Rockledge Drive, Room 4118A, 9529, 301–496–9223, Institutes of Health, HHS) MSC 7814, Bethesda, MD 20892, 301–435– 5575, [email protected]. [email protected]. Dated: August 1, 2013. This notice is being published less than 15 Michelle Trout, (Catalogue of Federal Domestic Assistance days prior to the meeting due to the timing Program Nos. 93.306, Comparative Medicine; Program Analyst, Office of Federal Advisory limitations imposed by the review and 93.333, Clinical Research, 93.306, 93.333, Committee Policy. funding cycle. 93.337, 93.393–93.396, 93.837–93.844, [FR Doc. 2013–18990 Filed 8–6–13; 8:45 am] (Catalogue of Federal Domestic Assistance 93.846–93.878, 93.892, 93.893, National Program Nos. 93.853, Clinical Research BILLING CODE 4140–01–P Institutes of Health, HHS) Related to Neurological Disorders; 93.854, Dated: August 1, 2013. Biological Basis Research in the Neurosciences, National Institutes of Health, DEPARTMENT OF HEALTH AND Carolyn A. Baum, HHS) HUMAN SERVICES Program Analyst, Office of Federal Advisory Committee Policy. Dated: August 1, 2013. National Institutes of Health [FR Doc. 2013–18961 Filed 8–6–13; 8:45 am] Carolyn Baum, BILLING CODE 4140–01–P Program Analyst, Office of Federal Advisory Center for Scientific Review; Notice of Committee Policy. Closed Meetings [FR Doc. 2013–18962 Filed 8–6–13; 8:45 am] Pursuant to section 10(d) of the BILLING CODE 4140–01–P Federal Advisory Committee Act, as

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DEPARTMENT OF HOMELAND STAN to deviate from the requirements Floor, Room W12–140, 1200 New Jersey SECURITY set forth in Annex I of the Inland Rules Avenue SE., Washington, DC 20590– Act, and install a lower masthead light 0001. Coast Guard to substitute for the ordinary pair of (4) Hand delivery: Same as mail [Docket No. USCG–2013–0696] masthead lights. The regularly address above, between 9 a.m. and 5 positioned masthead lights will still be p.m., Monday through Friday, except Certificate of Alternative Compliance installed, but will be retracted Federal holidays. The telephone number for the M/V IRON STAN, 1246342 throughout its tour underneath the is 202–366–9329. bridges on the Chicago River only. AGENCY: Coast Guard, DHS. This notice is issued under authority To avoid duplication, please use only ACTION: Notice. of 33 U.S.C. 1605(c), and 33 CFR 81.18. one of these four methods. See the ‘‘Public Participation and Request for SUMMARY: The Coast Guard announces Dated: July 30, 2013. Comments’’ portion of the that a Certificate of Alternative P. Albertson, SUPPLEMENTARY INFORMATION section Compliance was issued for the Captain, U.S. Coast Guard, Chief, Prevention below for instructions on submitting Uninspected Towing Vessel M/V IRON Division, Ninth Coast Guard District. comments. STAN as required by 33 U.S.C. 1605(c) [FR Doc. 2013–19101 Filed 8–6–13; 8:45 am] and 33 CF. 81.18. If you have questions on this notice, BILLING CODE 9110–04–P call or email Commander Michael DATES: The Certificate of Alternative Zamperini, U.S. Coast Guard; telephone Compliance was issued on June 10, (202) 372–1230, email 2013. DEPARTMENT OF HOMELAND [email protected]. If you SECURITY ADDRESSES: The docket for this notice is have questions on viewing or submitting available for inspection or copying at Coast Guard material to the docket, call Barbara the Docket Management Facility (M–30), Hairston, Program Manager, Docket U.S. Department of Transportation, [Docket No. USCG–2013–0491] Operations, telephone 202–366–9826. West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Consolidation of Officer in Charge, SUPPLEMENTARY INFORMATION: Marine Inspection For Outer Washington, DC 20590, between 9 a.m. A. Public Participation and Request for Continental Shelf Activities; Eighth and 5 p.m., Monday through Friday, Comments except Federal holidays. You may also Coast Guard District We encourage you to submit find this docket on the Internet by going AGENCY: Coast Guard, DHS. to http://www.regulations.gov, inserting comments and related material in ACTION: USCG–2013–0696 in the ‘‘SEARCH’’ Notice and request for response to this notice. All comments box, and then clicking ‘‘Search.’’ comments. received will be posted, without change, FOR FURTHER INFORMATION CONTACT: If SUMMARY: The Coast Guard is to http://www.regulations.gov and will you have questions on this notice, call considering establishing a single Officer include any personal information you LT Steven Melvin, District Nine, in Charge, Marine Inspection (OCMI) to have provided. Prevention Branch, U.S. Coast Guard, oversee marine inspections for all Submitting comments: If you submit a telephone 216–902–6343. If you have Mobile Offshore Drilling Units and comment, please include the docket questions on viewing or submitting Floating Outer Continental Shelf number for this notice (USCG–2013– material to the docket, call Barbara Facilities (as defined in Coast Guard 0491) and provide a reason for each Hairston, Program Manager, Docket regulations) engaged directly in, capable suggestion or recommendation. You Operations, telephone 202–366–9826. of engaging directly in, or being may submit your comments and SUPPLEMENTARY INFORMATION: constructed to engage directly in oil and material online, or by fax, mail or hand Background and Purpose gas exploration or production in the delivery, but please use only one of offshore waters of the Eighth Coast these means. We recommend that you A Certificate of Alternative Guard District (referred to hereafter include your name and a mailing Compliance, as allowed for under 33 collectively as ‘‘units’’). Currently, these address, an email address, or a U.S.C. 1605(c) and 33 CFR 81.18, has units are inspected by six separate telephone number in the body of your been issued for the M/V IRON STAN. OCMI offices across the Eighth Coast document so that we can contact you if The vessel’s primary purpose is to push District. The Coast Guard believes that we have questions regarding your a passenger barge that operates on the the consolidation of the six existing submission. Chicago River and a limited area of Lake OCMI offices into one will promote Michigan, within 1 mile of shore. The To submit your comment online, go to efficiency and consistency for both the http://www.regulations.gov, and follow unique design of the vessel did not lend Coast Guard and the regulated industry. itself to full compliance with Annex I of the instructions on that Web site. If you the Inland Rules Act. DATES: Comments and related material submit your comments by mail or hand The Commandant, U.S. Coast Guard, must be received on or before delivery, submit them in an unbound certifies that full compliance with the September 6, 2013. format, no larger than 81⁄2 by 11 inches, Inland Rules Act would interfere with ADDRESSES: You may submit comments suitable for copying and electronic the special functions/intent of the vessel identified by docket number USCG– filing. If you submit comments by mail and would not significantly enhance the 2013–0491 using any one of the and would like to know that they safety of the vessel’s operation. Placing following methods: reached the Facility, please enclose a the masthead light in the required (1) Online: http:// stamped, self-addressed postcard or position would interfere with the www.regulations.gov. envelope. We will consider all vessel’s ability to pass under bridges on (2) Fax: 202–493–2251. comments and material received during the Chicago River. (3) Mail: Docket Management Facility the comment period and may change The Certificate of Alternative (M–30), U.S. Department of this proposed rule based on your Compliance authorizes the M/V IRON Transportation, West Building Ground comments.

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B. Viewing Comments and Documents being geographically separated from the offshore supply vessels, crew boats, To view comments, go to http:// Eighth Coast Guard District office, accommodation vessels, and similar www.regulations.gov, and follow the commanding officers exercise vessels that routinely call on ports as instructions on that Web site. If you do independent military justice and falling under the authority of the OCS not have access to the internet, you may disciplinary authority over their entire OCMI. Those vessels would continue to view the docket online by visiting the staff. Commanding officers in the Eighth be inspected by the six existing OCMIs. Docket Management Facility in Room Coast Guard District report directly to We are seeking public comment on W12–140 on the ground floor of the the Eighth Coast Guard District the following questions to assist us in Department of Transportation West Commander in New Orleans. determining whether consolidating the Building, 1200 New Jersey Avenue SE., Commanding officers also serve other OCMI function as described above is Washington, DC 20590, between 9 a.m. statutory functions within their advisable and, if so, the manner in and 5 p.m., Monday through Friday, geographic area such as Federal On- which it should be implemented: except Federal holidays. We have an Scene Coordinator (FOSC) for oil and (1) Do you support the consolidation agreement with the Department of hazardous material spills, Captain of the of the OCMI function into a single office Transportation to use the Docket Port (COTP), and Federal Maritime for the oversight and inspection of units Management Facility. Security Coordinator (FMSC). As operating on the OCS in the Eighth OCMIs, they have authority to Coast Guard District? Why or why not? C. Privacy Act independently render decisions (2) If a consolidated OCMI for the Anyone can search the electronic effecting the approval or disapproval of OCS were created, which of the form of comments received into any of certain vessels to operate on the OCS. following options is the most our dockets by the name of the Any appeal of a decision made by an appropriate organizational placement of individual submitting the comment (or OCMI is made to the District the consolidated OCMI within the signing the comment, if submitted on Commander in accordance with 33 CFR Eighth Coast Guard District? (In each of behalf of an association, business, labor 1.03–20. the scenarios below, appeals to union, etc.). You may review a Privacy In order to understand the various decisions made by the consolidated Act notice regarding our public dockets options discussed later in this notice, it OCMI would be made to the Eighth in the January 17, 2008, issue of the is important to note that the Eighth Coast Guard District Commander.) Are Federal Register (73 FR 3316). Coast Guard District Commander also there other options we should consider? has various division chiefs on staff. (a) Consolidate the OCMI function D. Public Meeting Unlike commanding officers, division into one of the six existing OCMIs. This We do not now plan to hold a public chiefs do not exercise military justice OCMI would retain the title of meeting. But you may submit a request authority over their staffs and are co- commanding officer they already have for one to the docket using one of the located with the District Commander. at their current unit, but their OCMI methods specified under ADDRESSES. In Division chiefs report directly to the authority to inspect units would be your request, explain why you believe a District Commander and historically expanded to include all of the Eighth public meeting would be beneficial. If have not served as OCMI, FOSC, COTP, Coast Guard District. we determine that one would aid this or FMSC. Should the role of OCMI be (b) Make the consolidated OCMI a rulemaking, we will hold one at a time assigned to a division chief, appeals member of the staff of one of the six and place announced by a later notice from the OCMI level would also be existing OCMIs. This OCMI would not in the Federal Register. made to the District Commander. hold the title of commanding officer. Vessels requiring Coast Guard (c) Make the consolidated OCMI a Basis and Purpose inspection include Mobile Offshore division chief on the Eighth Coast Guard The Eighth Coast Guard District in Drilling Units (MODUs), Floating Outer District staff. This OCMI would not hold New Orleans, Louisiana has six OCMI Continental Shelf (OCS) Facilities (as the title of commanding officer. field offices located along the Gulf Coast defined in 33 CFR 140.10), and other (d) Create a new command separate in Mobile, Alabama; New Orleans, similar vessels that engage in oil and gas from the existing six OCMI commands Louisiana; Morgan City, Louisiana; Port exploration and production on the OCS. with the consolidated OCMI as the Arthur, Texas; Houston, Texas; and Coast Guard OCMIs are required to commanding officer. Corpus Christi, Texas. Currently, each of inspect these units when they are (3) If the consolidated OCMI for the these offices has full OCMI authority to operating on the OCS. OCS were created, where in the Eighth conduct inspections of all vessels The offshore oil and gas industry is Coast Guard District should the offices required to undergo Coast Guard currently experiencing substantial of the consolidated OCMI be physically inspection within their respective zones growth in the Gulf of Mexico. As a located? as defined in 33 CFR part 3. The result, unit construction and operation We ask that all comments submitted functions of an OCMI are found in 33 in the Gulf of Mexico is expected to in response to this request include the CFR 1.01–20 and include inspection of increase by 60% in the next five years. reasoning behind the comment to better vessels in order to determine that they In order to keep pace with this growth, inform our decision making. This comply with the applicable laws, rules, the Coast Guard is considering ways to request for comments should not be and regulations relating to safe increase efficiency and streamline construed as suggesting that the Eighth construction, equipment, manning, and inspection of offshore units. We are Coast Guard District will create a operation and that they are in a considering creating one office to serve consolidated OCMI for the OCS. seaworthy condition for the services in as OCMI for MODUs and Floating OCS Whether, and in what format, this which they are operated. facilities, creating a single point of position would be created will depend At the six field offices listed above, contact for scheduling inspections and on a number of factors including public the OCMI also serves as the promoting consistency of regulatory responses to this request, staffing commanding officer of the unit. The interpretation and enforcement across requirements, legal constraints, and title ‘‘commanding officer’’ refers to the the Gulf for units operating on the OCS. budget impacts. highest ranking military official at a At this time, we are not suggesting the Specific questions regarding this Coast Guard field office. In addition to inclusion of support vessels such as request should be addressed to

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Commander Michael Zamperini whose is to allow for 60 days of public Copies of available documents contact information is located above the comment. submitted to OMB may be obtained ‘‘For Further Information Contact’’ from Ms. Mussington. DATES: Comments Due Date: October 7, section. SUPPLEMENTARY INFORMATION: This This notice is issued under the 2013. ADDRESSES: Interested persons are notice informs the public that HUD is authority of 5 U.S.C 552(a), 14 U.S.C. seeking approval from OMB for the 92, and DHS Delegation 0170.1 II (23). invited to submit comments regarding this proposal. Comments should refer to information collection described in Dated: August 1, 2013. the proposal by name and/or OMB Section A. J. C. Burton, Control Number and should be sent to: A. Overview of Information Collection Captain, U.S. Coast Guard, Director of Colette Pollard, Reports Management Inspections & Compliance. Officer, QDAM, Department of Housing Title of Information Collection: [FR Doc. 2013–19098 Filed 8–6–13; 8:45 am] and Urban Development, 451 7th Street Promise Zones. BILLING CODE 9110–04–P SW., Room 4176, Washington, DC OMB Approval Number: Pending 20410–5000; telephone 202–402–5564 OMB approval. (this is not a toll-free number) or email Type of Request: New Collection. DEPARTMENT OF HOUSING AND at [email protected] for a copy of Form Number: Pending Assignment. URBAN DEVELOPMENT the proposed forms or other available Description of the need for the [Docket No. FR–5690–N–10] information. Persons with hearing or information and proposed use: Under speech impairments may access this the Promise Zones initiative, the federal 60-Day Notice of Proposed Information number through TTY by calling the toll- government will invest and partner with Collection: Promise Zones free Federal Relay Service at (800) 877– high-poverty urban, rural, and tribal 8339. AGENCY: Office of the Assistant communities to create jobs, increase Secretary for Public and Indian FOR FURTHER INFORMATION CONTACT: economic activity, improve educational Housing, HUD. Arlette Mussington, Office of Policy, opportunities, leverage private investment, and reduce violent crime. ACTION: Notice. Programs and Legislative Initiatives, PIH, Department of Housing and Urban Additional information about the SUMMARY: HUD is seeking approval from Development, 451 7th Street SW., Promise Zones initiative can be found at the Office of Management and Budget (L’Enfant Plaza, Room 2206), www.hud.gov/promisezones, and (OMB) for the information collection Washington, DC 20410; telephone 202– questions can be addressed to described below. In accordance with the 402–4109. This is not a toll-free number. [email protected]. This notice Paperwork Reduction Act, HUD is Persons with hearing or speech estimates burden for applying for the requesting comment from all interested impairments may access this number designation. parties on the proposed collection of through TTY by calling the toll-free Respondents (i.e. affected public): information. The purpose of this notice Federal Relay Service at (800) 877–8339. State, Local, or Tribal Governments.

Number of Frequency of Responses Burden hour Annual burden Hourly cost Information collection respondents response per annum per response hours per response Annual cost

Qualifying Criteria/ Need—City and Neighborhood Maps 78 1 1 1 78 $40 $3120 Local leadership support—Documenta- tion ...... 78 1 1 1 78 40 3120 Need—Poverty rate ... 78 1 1 1 78 40 3120 Need—Crime rate ...... 78 1 1 1 78 40 3120 Need—Employment rate ...... 78 1 1 1 78 40 3120 Need—Vacancy rate .. 78 1 1 1 78 40 3120 Strategy—Community Assets and Neigh- borhood Position .... 78 1 1 1 78 40 3120 Strategy—Narrative .... 78 1 1 2 156 40 6240 Strategy—Evidence base ...... 78 1 1 1 78 40 3120 Strategy—Sustain- ability and financial feasibility ...... 78 1 1 1 78 40 3120 Capacity—Lead documentation ...... 78 1 1 1 78 40 3120 Capacity—Partner documentation ...... 78 1 1 1.5 117 40 4680 Capacity—Partner Or- ganization Chart..... 78 1 1 2 156 40 6240 Capacity—Local government ...... 78 1 1 1 78 40 3120 Capacity—Partnership commitments documentation ...... 78 1 1 1.5 117 40 4680

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Number of Frequency of Responses Burden hour Annual burden Hourly cost Information collection respondents response per annum per response hours per response Annual cost

Total ...... 78 1 1 18 1404 40 56,160

B. Solicitation of Public Comment Mountain Arsenal National Wildlife Introduction This notice is soliciting comments Refuge in Commerce City, Colorado. With this notice, we initiate our from members of the public and affected The Service also intends to prepare a process for developing CCPs for the parties concerning the collection of CCP and an Environmental Assessment Rocky Mountain Arsenal National information described in Section A on for the Two Ponds National Wildlife Wildlife Refuge in Commerce City, CO, the following: Refuge in Arvada, Colorado. These and the Two Ponds National Wildlife (1) Whether the proposed collection refuges are currently being managed Refuge in Arvada, CO. This notice of information is necessary for the under Comprehensive Management complies with our CCP policy to (1) proper performance of the functions of Plans developed in the mid-1990s and advise other Federal and State agencies, the agency, including whether the as part of the Rocky Mountain Arsenal Tribes, and the public of our intention information will have practical utility; National Wildlife Refuge Complex. We to conduct detailed planning on these (2) The accuracy of the agency’s provide this notice in compliance with refuges and (2) to obtain suggestions and estimate of the burden of the proposed our CCP policy to advise other Federal information on the scope of issues to collection of information; and State agencies, Tribes, and the consider in the environmental (3) Ways to enhance the quality, public of our intentions, and to obtain document and during development of utility, and clarity of the information to suggestions and information on the the CCPs. be collected; and scope of issues to consider in the (4) Ways to minimize the burden of planning process of revising the Background the collection of information on those management plans for these refuges. The CCP Process who are to respond; including through DATES: To ensure consideration, please The National Wildlife Refuge System the use of appropriate automated send your written comments by October Administration Act of 1966 (16 U.S.C. collection techniques or other forms of 11, 2013. Submit comments by one of 668dd–668ee) (Administration Act) as information technology, e.g., permitting the methods under ADDRESSES. We will amended by the National Wildlife electronic submission of responses. announce opportunities for public input Refuge System Improvement Act of HUD encourages interested parties to in local news media throughout the CCP 1997, requires us to develop a CCP for submit comment in response to these process. each unit of the National Wildlife questions. ADDRESSES: Send your comments or Refuge System (NWRS). The purpose for Authority: Section 3507 of the Paperwork requests for more information by any of developing a CCP is to provide the Reduction Act of 1995, 44 U.S.C. Chapter 35. the following methods. managers of the units of the NWRS with Dated: August 1, 2013. a 15-year plan for achieving the units’ Email: purposes and contributing toward the Merrie Nichols-Dixon, [email protected]. Include Deputy Director, Office of Policy, Programs mission of the NWRS, consistent with ‘‘Rocky Mountain Arsenal National sound principles of fish and wildlife and Legislative Initiatives. Wildlife Refuge CCP’’ or ‘‘Two Ponds [FR Doc. 2013–18992 Filed 8–6–13; 8:45 am] management, conservation, legal National Wildlife Refuge CCP,’’ as mandates, and our policies. In addition BILLING CODE 4210–67–P appropriate, in the subject line of the to outlining broad management message. direction on conserving wildlife and Fax: Attn: Bernardo Garza and Toni their habitats, CCPs identify compatible DEPARTMENT OF THE INTERIOR Griffin, Planning Team Leaders, 303/ wildlife-dependent recreational 236–4792. Fish and Wildlife Service opportunities available to the public, U.S. Mail: Bernardo Garza and Toni including, where appropriate, [FWS–R6–R–2013–N147; Griffin, Planning Team Leaders, opportunities for hunting, fishing, FXRS1265066CCP0–134–FF06R06000] Division of Refuge Planning, P.O. Box wildlife observation and photography, 25486, Denver, CO 80225–0486. and environmental education and Rocky Mountain Arsenal National interpretation. We will review and Wildlife Refuge, Commerce City, CO; In-Person Drop-off: You may drop off update the CCPs at least every 15 years Comprehensive Conservation Plan and comments during regular business hours in accordance with the Administration Environmental Impact Statement; Two at the above address, or at the Rocky Act. Ponds National Wildlife Refuge, Mountain Arsenal National Wildlife Refuge Complex administrative office Each unit of the NWRS was Arvada, CO; Comprehensive established for specific purposes. We Conservation Plan and Environmental located at 6550 Gateway Road, Commerce City, CO 80022. use these purposes as the foundation for Assessment developing and prioritizing the FOR FURTHER INFORMATION CONTACT: AGENCY: management goals and objectives for Fish and Wildlife Service, Bernardo Garza, 303/236–4377 (phone) Interior. _ each unit within the NWRS and to or bernardo [email protected] (email); determine how the public can enjoy ACTION: Notice of intent; request for Toni Griffin, 303/236–4378 (phone) or comments. _ public uses in the NWRS units. The toni [email protected] (email); or David C. planning process is a way for us and the SUMMARY: We, the U.S. Fish and Lucas, Chief, Division of Planning, 303/ public to evaluate management goals Wildlife Service (Service), intend to 236–4366 (phone), P.O. Box 25486, and objectives that will ensure the best prepare a Comprehensive Conservation Denver Federal Center, Denver, CO possible approach to wildlife, plant, and Plan (CCP) and an Environmental 80225–0486. habitat conservation, while providing Impact Statement (EIS) for the Rocky SUPPLEMENTARY INFORMATION: for wildlife-dependent recreation

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opportunities that are compatible with endangered mammals in the world. D The Refuge’s role on the Rocky each of the unit’s establishing purposes Historically, this ferret species occurred Mountain Greenway Trail and other and the mission of the NWRS. throughout the Great Plains wherever such efforts Our CCP process provides prairie dogs (Cynomys spp.) were found. D The Refuges’ role in the Service’s participation opportunities for Tribal, As a highly specialized predator, black- ‘‘Connecting People with Nature’’ and State, and local governments; agencies; footed ferrets prey upon prairie dogs other initiatives organizations; and the public. At this and use their underground burrows for D Relationship of the CCP to other time we encourage input in the form of shelter. Black-footed ferrets and prairie landscape wide conservation efforts issues, concerns, ideas, and suggestions dogs are part of an ecosystem that has D Implications of outdoor recreational for the future management of the Rocky been dramatically altered and reduced opportunities on the Refuges’ habitats Mountain Arsenal and Two Ponds in size over the past century. The and wildlife National Wildlife Refuges. proposed reintroduction of the black- D Habitat and invasive species We will conduct the environmental footed ferret to this refuge is a positive management D review of these projects in accordance step toward the recovery of this iconic Successful outreach and engagement with the requirements of the National prairie species. of nontraditional publics Environmental Policy Act of 1969, as D Expanding commercial development amended (NEPA) (42 U.S.C. 4321 et Two Ponds National Wildlife Refuge and urbanization surrounding the seq.); NEPA regulations (40 CFR parts The Two Ponds National Wildlife Refuge D 1500–1508 and 43 CFR part 46); other Refuge—located in the heart of the City Necessary infrastructure (e.g., appropriate Federal laws and of Arvada, Colorado—is one the boardwalk, interpretive signs, parking regulations; and our policies and smallest urban unit of the NWRS and is lot, etc.) D Involvement of different publics in procedures for compliance with those part of the Rocky Mountain Arsenal the Refuge’s wildlife-dependent laws and regulations. National Wildlife Refuge Complex. This public uses Rocky Mountain Arsenal National refuge is about 72 acres in size and D Law enforcement Wildlife Refuge consists of important fish and wildlife D Habitat management tools, such as fire habitats such as native shortgrass The Rocky Mountain Arsenal and chemical control, in highly prairie, native mixed-grass prairie, and urbanized areas National Wildlife Refuge is one of the wetland. The Two Ponds National nation’s premier urban national wildlife D Protection of remedy and facilities Wildlife Refuge supports many animals, refuges. Located within the highly under the Comprehensive including more than 120 species of urbanized Denver Metropolitan Area, it Environmental Response, birds, coyote and red fox, muskrat, is approximately 16,000 acres in size Compensation, and Liability Act and raccoon, and beaver, deer, several and consists of a number of important the Resource Conservation and species of small mammals, amphibians, fish and wildlife habitats, including Recovery Act reptiles, and fish. In 1990, a local native shortgrass and mixedgrass citizen’s group—the Two Ponds Two Ponds NWR prairies, riparian corridors, numerous Preservation Foundation—was D wetlands, and multiple lakes. The U.S. Management and implications of the instrumental in preserving this site from Army and Shell Corporation recently water canals that cross the refuge to finished their remediation of the site, development. The group’s efforts surrounding cities D The Refuges’ urban and wildlife which included restoring thousands of contributed to the establishment of this acres of native grasslands, and the site refuge in 1992. Since then, the refuge interface as a gateway community and is now being managed for wildlife staff has worked to restore, enhance, urban refuge D The Refuge’s role on the Rocky conservation and compatible, wildlife- and preserve a diversity of upland and Mountain Greenway Trail and other dependent public uses. This refuge wetland habitats for migratory and such efforts supports many animals, including more resident wildlife, and to provide many visitor experiences. Located D The Refuges’ role in the Service’s than 271 species of birds, such as bald ‘‘Connecting People with Nature’’ and eagles, burrowing owls, and Swainson’s conveniently within the Denver metro other initiatives hawks; coyote and red fox; bison and area, the refuge provides a unique opportunity for people to connect with D Implications of outdoor recreational deer; raccoon and several other species opportunities on the Refuges’ habitat of small mammals, amphibians, reptiles, their natural environment. A variety of wildlife-dependent recreational and wildlife and fish. Without traveling far from the D Habitat and invasive species Colorado Front Range region, people opportunities is available annually to more than 15,000 visitors—people can management have a unique opportunity to connect D hike trails, observe and photograph Existing vs. necessary infrastructure with their natural environment. There (e.g., buildings, water control are a variety of wildlife-dependent wildlife, participate in environmental education programs, volunteer their structures, etc.) recreational opportunities available to D Involvement of different publics in talents, and join in a diverse array of the over 300,000 annual visitors, such as the Refuge’s wildlife-dependent community service projects. hiking trails, observing wildlife from the public uses Auto Tour Route or the Wildlife Drive, Scoping: Preliminary Issues, Concerns, D Habitat management tools, such as fire participating in environmental and Opportunities and chemical control, in a highly education programs, and experiencing urbanized area one of the best catch-and-release Rocky Mountain Arsenal NWR We request input on these issues and fisheries in Colorado. As part of the D Possibility of reintroducing black- other concerns affecting refuge planning process, this refuge is footed ferrets: Habitat and prey needs; management or public use during the considering reintroducing the protection planning process. We are especially endangered black-footed ferret (Mustela D Management of the bison herd interested in receiving public input in nigripes). This federally listed species is D The Refuges’ urban and wildlife the following areas: the only ferret native to North America interface as a gateway community and (a) What suggestions do you have for and is considered one of the most urban refuge managing wildlife and habitat on the

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refuges in the face of possible climate DEPARTMENT OF THE INTERIOR bounds of the Steens Mountain CMPA; change and declining precipitation? recommending cooperative programs Bureau of Land Management (b) What ideas do you have regarding and incentives for landscape visitor services and wildlife-dependent [LLORB00000.L17110000.PH0000. management that meet human needs, public uses on the refuges? L.X.SS.020H0000; HAG13–0257] and the maintenance and improvement of the ecological and economic integrity (c) What changes, if any, would you Steens Mountain Advisory Council; of the area. Tentative agenda items for like to see in the management of Rocky Public Meeting Date Change the September 30–October 1, 2013, Mountain Arsenal and Two Ponds meeting include: The Steens Mountain National Wildlife Refuges? AGENCY: Bureau of Land Management, Comprehensive Recreation Plan, the Interior. (d) What concerns do you have South Steens Allotment Management regarding bison and prairie dog ACTION: Notice of Change in Public Plan, the BLM’s Wild Horse and Burro management or the reintroduction of Meeting Date. Program, juniper management and Sage- grouse, and future meeting agendas, species such as black-footed ferret at the SUMMARY: In accordance with the Rocky Mountain Arsenal NWR? dates, and locations. Any other matters Federal Land Policy and Management that may reasonably come before the We provide the above questions for Act and the Federal Advisory SMAC may also be addressed. This your optional use. We have no Committee Act of 1972, and the U.S. meeting is open to the public in its requirement that you provide Department of the Interior, Bureau of entirety. Information to be distributed to information; however, any comments Land Management (BLM), the Steens the SMAC is requested prior to the start the planning team receives will be used Mountain Advisory Council (SMAC) of each meeting. as part of the planning process. will meet as indicated below: Before including your address, phone DATES: The August 15–16, 2013 SMAC number, email address, or other Public Meetings meeting has been rescheduled for personal identifying information in your We will give the public opportunities Monday, September 30, and Tuesday, comments, please be aware that your to provide initial input via telephone, October 1, 2013, in Hines, Oregon. The entire comment—including your exact meeting time, agenda, and email, postal mail, fax (see ADDRESSES), personal identifying information—may location will be announced online at and in person at public scoping be made publicly available at any time. www.blm.gov/or/rac/steens-rac- meetings we will host throughout the While you can ask us in your comment minutes.php prior to September 20, to withhold your personal identifying Denver Metropolitan Area in July, 2013. A public comment period will be August, and September, 2013. We will information from public review, we available each day of the session. Unless cannot guarantee that we will be able to announce the details of the public otherwise approved by the SMAC Chair, do so. meetings and other opportunities for the public comment period will last no public input in local news media longer than 30 minutes, and each Brendan Cain, throughout the CCP process. You may speaker may address the SMAC for a Burns District Manager. also send comments anytime during the maximum of 5 minutes. Meeting times [FR Doc. 2013–19032 Filed 8–6–13; 8:45 am] planning process by U.S. mail, email, or and the duration scheduled for public BILLING CODE 4310–13–P fax. There will be additional comment periods may be extended or opportunities to provide public input altered when the authorized and comments once we have prepared representative considers it necessary to DEPARTMENT OF THE INTERIOR a draft CCP. accommodate necessary business and all who seek to be heard regarding Bureau of Reclamation Public Availability of Comments matters before the SMAC. [A10–1517–0008–000–00–0–2, 4P10000] Any comments we receive will FOR FURTHER INFORMATION CONTACT: Tara Notice of Intent To Contract for become part of the administrative record Martinak, Public Affairs Specialist, BLM Hydroelectric Power Development on and may be available to the public. Burns District Office, 28910 Highway 20 West, Hines, Oregon 97738–9424, (541) the San Juan-Chama Project, New Before submitting comments that Mexico include your address, phone number, 573–4519, or email [email protected]. email address, or other personal Persons who use a telecommunications AGENCY: Bureau of Reclamation, identifying information, you should be device for the deaf (TDD) may call the Interior. Federal Information Relay Service aware that your entire comment, ACTION: Notice of intent to accept (FIRS) at 1(800) 877–8339 to contact the including your personal identifying proposals, select lessee, and contract for above individual during normal information, may be made publicly hydroelectric power development on business hours. The FIRS is available 24 available at any time. While you may the San Juan-Chama Project. hours a day, 7 days a week, to leave a ask us in your comment to withhold message or question with the above SUMMARY: your personal identifying information Current Federal policy allows individual. You will receive a reply non-Federal development of electrical from public review, we cannot during normal business hours. power resource potential on Federal guarantee that we will be able to do so. SUPPLEMENTARY INFORMATION: The water resource projects. The Bureau of Dated: July 10, 2013. SMAC was initiated August 14, 2001, Reclamation, (Reclamation), in Matt Hogan, pursuant to the Steens Mountain coordination with the Department of Acting Regional Director, U. S. Fish and Cooperative Management and Protection Energy, Western Area Power Wildlife Service, Mountain-Prairie Region. Act (CMPA) of 2000 (Pub. L. 106–399). Administration (Western), will consider [FR Doc. 2013–19052 Filed 8–6–13; 8:45 am] The SMAC provides representative proposals for non-Federal development counsel and advice to the BLM of hydroelectric power on the San Juan- BILLING CODE 4310–55–P regarding new and unique approaches Chama Project at any or all of the to management of the land within the conduit locations specified in this

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Notice. Reclamation is considering such Chama, New Mexico 87520–0426; accommodate existing contractual hydroelectric power development under telephone (575) 756–2175. commitments related to operation and a lease of power privilege. Western Information related to Western’s maintenance of the Azotea Tunnel would have the first opportunity to purchasing and/or marketing of the Outlet and other San Juan-Chama purchase and/or market the power that power may be obtained by contacting Project facilities. The lessee (i.e., would be generated by such Ms. Lynn Jeka, CRSP Manager, Western successful proposing entity) will be development under a lease of power Area Power Administration, 150 Social responsible for operation and privilege. No Federal funds will be Hall Avenue, Suite 300, Salt Lake City, maintenance of the proposed available for such hydroelectric power Utah 84111–1534; telephone (801) 524– hydropower development within the development. This Notice presents 6372. existing Federal features. Because the background information, proposal SUPPLEMENTARY INFORMATION: The San United States is responsible for the content guidelines, and information Juan-Chama Project was authorized as a operation and maintenance of the San concerning selection of a non-Federal participating project of the Colorado Juan-Chama Project, a negotiated entity to develop hydroelectric power River Storage Project on June 13, 1962, agreement will be included in the lease on the San Juan-Chama Project. by Public Law 87–483. The project is a development process to address coordination of operation and DATES: A written proposal and seven Federal Reclamation project located in maintenance, including cost-sharing copies must be submitted on or before northern New Mexico, near the town of arrangements associated with any 5:00 p.m. (Mountain Standard Time) on Chama, and diverts Colorado River additional operation and maintenance January 6, 2014. A proposal will be water through a series of three dams, costs incurred due to operation of the considered timely only if it is received three diversions, and three tunnels. The Azotea Tunnel Outlet empties into hydropower facilities. in the office of the Area Manager at or All costs incurred by the United Willow Creek and has the capacity to before 5:00 p.m. on the above- States related to development and deliver 950 cubic feet per second. designated date. Interested entities are operation and maintenance of the Reclamation maintains easements along cautioned that delayed delivery to the hydropower facilities under a lease of Willow Creek. The Jicarilla Apache Area Manager’s office due to failures or power privilege, including NEPA Indian Reservation is an adjacent misunderstandings of the entity and/or compliance and development of the landowner. of mail, overnight, or courier services lease of power privilege, would be at the will not excuse lateness and, Reclamation, in coordination with expense of the lessee. In addition, the accordingly, are advised to provide Western, is considering hydroelectric lessee would be required to make sufficient time for delivery. Late power development on the San Juan- annual payments to the United States proposals will not be considered. Chama Project under a lease of power for the use of a government facility in privilege at up to four conduit drops ADDRESSES: Send written proposal and the amount of at least 3 mills per along the project. These locations are seven copies to Mr. Mike Hamman, Area kilowatt-hour of generation. The lease the Azotea Tunnel Outlet, the drop Manager, Bureau of Reclamation, issued to the lessee will contain located at Station 1565+00, the drop Albuquerque Area Office, 555 Broadway provisions for inflation adjustments to located at Station 1702+75, and the drop NE., Suite 100, Albuquerque, New the required annual payments located at Station 1831+17. The station Mexico 87102–2352; telephone (505) throughout the term of the lease. Such drops are all located downstream of the 462–3551. A copy of the proposal annual payments to the United States Azotea Tunnel Outlet along Willow should also be sent at or about the time would be deposited as a credit to the Creek and are all features of the San it is due at Reclamation to Ms. Lynn Upper Colorado River Basin Fund. Juan-Chama Project. Jeka, CRSP Manager, Western Area A lease of power privilege is an Proposal Content Guidelines Power Administration, 150 Social Hall alternative to Federal hydroelectric Avenue, Suite 300, Salt Lake City, Utah Interested parties should submit power development. It is a contractual 84111–1534; telephone (801) 524–6372. proposals explaining in as precise detail right given to a non-Federal entity to use as is practicable how the hydropower FOR FURTHER INFORMATION CONTACT: a Reclamation facility for electric power potential would be developed. Technical data may be obtained from generation consistent with Reclamation Proposals may include any or all of the Mr. Joseph Alderete, Bureau of project purposes. Leases of power conduit drops specified in this Notice. Reclamation, Albuquerque Area Office, privilege have terms not to exceed 40 In their proposals, interested parties 555 Broadway NE., Suite 100, years. The general authority for lease of should: Albuquerque, New Mexico 87102–2352; power privilege under Reclamation law (a) Provide all information relevant to telephone (505) 462–3578. Reclamation includes, among others, the Town Sites the qualifications of the proposing will be available to meet with interested and Power Development Act of 1906 (43 entity to plan and implement such a entities only upon written request to Mr. U.S.C. 522) and the Reclamation Project project, including, but not limited to, Alderete. Upon request, Reclamation Act of 1939 (43 U.S.C. 485h(c)) (1939 information about preference status, the will provide an opportunity for a site Act). type of organization, length of time in visit. Reclamation reserves the right to Reclamation will be the lead Federal business, experience in funding, design schedule a single meeting and/or visit to agency for ensuring compliance with and construction of similar projects, address the questions of all entities that the National Environmental Policy Act industry rating(s) that indicate financial have submitted questions or requested (NEPA) for any lease of power privilege soundness and/or technical and site visits. considered in response to this Notice. A managerial capability, experience of key Information related to operation and lease of power privilege may be issued management personnel, history of any maintenance of the Azotea Tunnel and only after Reclamation has reviewed reorganizations or mergers with other the three other drop structures may be and approved compliance with NEPA, companies, and any other information obtained by contacting Mr. Alderete or the National Historic Preservation Act that demonstrates the interested entity’s Mr. Victor Salazar, Bureau of (NHPA), and the Endangered Species organizational, technical, and financial Reclamation, Chama Field Division, 193 Act (ESA). Any lease of power privilege ability to perform all aspects of the North Pinon Drive, P.O. Box 426, on the San Juan-Chama Project must work. Interested parties should also

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include a discussion of past experience with the San Juan-Chama Project and maintenance costs as well as the overall in operating and maintaining similar existing applicable contracts related to cost effectiveness of the power facilities and provide references as operation and maintenance of San Juan- produced at the proposed hydropower appropriate. The term ‘‘preference Chama Project feature(s) being facility; (4) the marketing plan for the entity,’’ as applied to a lease of power considered for modification. power produced at the proposed privilege, means an entity qualifying for (g) Describe plans for assuming hydropower facility; and (5) the preference under Section 9(c) of the liability for damage to the operational proposed organizational structure for 1939 Act as a municipality, public and structural integrity of the San Juan- the long-term operation and corporation or agency, or cooperative or Chama Project caused by construction, maintenance of the proposed other non-profit organization financed operation, and/or maintenance of the hydropower facility including the in whole or in part by loans made hydropower development. qualifications of the operating entity. A pursuant to the Rural Electrification Act (h) Identify the organizational proposal will be deemed unacceptable if of 1936, as amended. structure planned for the long-term it is inconsistent with San Juan-Chama (b) Provide geographical locations and operation and maintenance of any Project purposes, as determined by describe principal structures and other proposed hydropower development. Reclamation. important features of the proposed (i) Provide a management plan to Reclamation will give preference to development including roads and accomplish such activities as planning, those entities that qualify as preference transmission lines. Estimate and NEPA compliance, NHPA compliance, entities (as defined under Proposal describe installed capacity and the ESA compliance, lease of power Content Guidelines, item (a), of this capacity of the power facilities. Also privilege development, design, Notice) provided that their proposal is describe seasonal or annual generation construction, facility testing, and start of at least as well adapted to developing, patterns. Include estimates of the hydropower production. Prepare conserving, and utilizing the water and electrical energy that would be schedules of these activities as natural resources as other submitted produced from the facility for each applicable. Describe what studies are proposals and that the preference entity month in dry, average, and wet necessary to accomplish the is well qualified. Preference entities hydrologic scenarios. If capacity and hydroelectric power development and would be allowed 30 days to improve energy can be delivered to another how the studies would be implemented. their proposals, if necessary, to be made location, either by the proposing entity (j) Estimate development cost. This at least equal to a proposal(s) that may or by potential wheeling agents, specify cost should include all investment costs have been submitted by a non- where capacity and energy can be such as the cost of studies to determine preference entity. delivered. Include concepts for power feasibility, NEPA compliance, NHPA Power Purchasing and/or Marketing sales and contractual arrangements, compliance, ESA compliance, design, Considerations involved parties, and the proposed construction, and financing as well as approach to wheeling if required. the amortized annual cost of the Western would have the first (c) Indicate plans for acquiring title to investment. Also, the annual operation, opportunity to purchase and/or market or the right to occupy and use lands maintenance, and replacement expense the power that would be generated by necessary for the proposed for the hydropower development; the project under a lease of power development, including such additional annual lease payments to the United privilege and will be given 60 days from lands as may be required during States; expenses that may be associated the date of the initial offer from the construction. with the San Juan-Chama Project; and Lessee to make their decision. Western (d) Identify water rights applicable to the anticipated return on investment will consult with Reclamation on such the operation of the proposed should be included. If there are power purchasing and/or marketing development(s), the holder of such transmission or wheeling expenses considerations. rights, and how these rights would be associated with the hydropower In the event Western elects to used, acquired, or perfected. development, these should also be purchase and/or market the power (e) Discuss any studies necessary to included. Identify proposed methods of generated by the hydropower adequately define impacts of the financing the hydropower development. development, Western may market the development on the San Juan-Chama An economic analysis should be power available from the project as part Project and the environment. Describe presented that compares the present of its Salt Lake City Area Integrated any significant environmental issues worth of all benefits and the costs of the Projects (SLIP) or on a stand-alone basis, associated with the development and hydropower development. first to preference entities qualified the proposing entity’s approach for under criteria established by Western, gathering relevant data and resolving or Selection of Lessee and second to non-preference entities, mitigating such issues to protect and Proposals will be evaluated with by developing an individual marketing enhance the quality of the environment. equal consideration given to the plan for this power. This marketing plan Explain any proposed use of the following criteria: (1) The relevant would be developed through a separate hydropower development for qualifications of the proposing entity, subsequent public process beginning conservation and utilization of the based on past experience, to develop with a notice in the Federal Register of available water resources in the public similar hydropower projects in terms of Western’s intent to market the power. interest. complexity and scale; (2) the proposed The marketing plan would include all (f) Describe anticipated contractual overall design of the project in terms of aspects of marketing the power, arrangements with Reclamation, which how the principal structures fit within including assignment of power to has operation and maintenance the existing project features, including qualified preference and/or non- responsibility for the San Juan-Chama the optimization of developing the preference entities, pricing, Project feature(s), that are proposed for hydropower potential with transmission, and delivery of power. utilization in the hydropower consideration to environmental factors; Western would recover the costs it development under consideration. (3) the projected developmental and would incur in purchasing and/or Describe how the hydropower operational costs, including marketing the power through the rates development would operate in harmony construction, operation and charged for the power. Firm power rates

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would be established through a public Constitution Ave. NW., Room 203–SIB, consultation between the AML agency process, initiated by a notice in the Washington, DC 20240. Comments may and the appropriate Title V regulatory Federal Register, separate from the also be submitted electronically to authority on the likelihood of removing marketing plan. [email protected]. the coal under a Title V permit and concurrences between the AML agency Notice and Time Period To Enter Into FOR FURTHER INFORMATION CONTACT: To and the appropriate Title V regulatory Lease of Power Privilege receive a copy of the information collection request contact John Trelease authority on the AML project boundary Reclamation will notify, in writing, all at (202) 208–2783, or via email at and the amount of coal that would be entities submitting proposals of [email protected]. extracted under the AML reclamation Reclamation’s decision regarding project. selection of the potential lessee. The SUPPLEMENTARY INFORMATION: The Office Bureau Form Number: None. selected potential lessee will have 15 of Management and Budget (OMB) Frequency of Collection: Once. months from the date of such regulations at 5 CFR 1320, which Description of Respondents: 17 State notification to accomplish NEPA implement provisions of the Paperwork regulatory authorities and Indian tribes. compliance, NHPA compliance, ESA Reduction Act of 1995 (Pub. L. 104–13), Total Annual Responses: 17. compliance, and enter into a lease of require that interested members of the Total Annual Burden Hours: 1,411. power privilege for the proposed public and affected agencies have an Dated: August 1, 2013. development of hydropower on the San opportunity to comment on information Juan-Chama Project. The lease of power collection and recordkeeping activities Andrew F. DeVito, privilege will address only the sites [see 5 CFR 1320.8 (d)]. This notice Chief, Division of Regulatory Support. identified in the lessee’s proposal and identifies the information collection that [FR Doc. 2013–19042 Filed 8–6–13; 8:45 am] will not provide broad development OSM will be submitting to OMB for BILLING CODE 4310–05–P rights elsewhere on the San Juan-Chama extension. This collection is contained Project. The lessee will then have up to in 30 CFR Part 874. 9 months from the date of execution of OSM has revised burden estimates, INTERNATIONAL TRADE the lease to complete the designs and where appropriate, to reflect current COMMISSION specifications and an additional year to reporting levels or adjustments based on begin construction. Such timeframes reestimates of burden or number of [Docket No. 2971] may be adjusted for just cause resulting respondents. OSM will request a 3-year Certain Flash Memory Chips and from actions and/or circumstances that term of approval for this information Products Containing the Same Notice are beyond the control of the lessee. collection activity. Comments are invited on: (1) The of Receipt of Complaint; Solicitation of Dated: June 27, 2013. need for the collection of information Comments Relating To the Public Larry Walkoviak, for the performance of the functions of Interest Regional Director, Upper Colorado Region. the agency; (2) the accuracy of the AGENCY: U.S. International Trade [FR Doc. 2013–18911 Filed 8–6–13; 8:45 am] agency’s burden estimates; (3) ways to Commission. BILLING CODE 4310–MN–P enhance the quality, utility and clarity of the information collections; and (4) ACTION: Notice. ways to minimize the information SUMMARY: DEPARTMENT OF THE INTERIOR Notice is hereby given that collection burden on respondents, such the U.S. International Trade as use of automated means of collection Commission has received a complaint Office of Surface Mining Reclamation of the information. A summary of the and Enforcement entitled Certain Flash Memory Chips public comments will accompany and Products Containing the Same, DN [S1D1S SS08011000 SX066A000 67F OSM’s submission of the information 2971; the Commission is soliciting 134S180110; S2D2S SS08011000 SX066A00 collection request to OMB. comments on any public interest issues 33F 13xs501520] Before including your address, phone raised by the complaint or number, email address, or other complainant’s filing under section Notice of Proposed Information personal identifying information in your 210.8(b) of the Commission’s Rules of Collection; Request for Comments comment, you should be aware that Practice and Procedure (19 CFR your entire comment—including your AGENCY: Office of Surface Mining 210.8(b)). Reclamation and Enforcement. personal identifying information—may be made publicly available at any time. FOR FURTHER INFORMATION CONTACT: Lisa ACTION: Notice and request for While you can ask us in your comment R. Barton, Acting Secretary to the comments. to withhold your personal identifying Commission, U.S. International Trade SUMMARY: In compliance with the information from public review, we Commission, 500 E Street SW., Paperwork Reduction Act of 1995, the cannot guarantee that we will be able to Washington, DC 20436, telephone (202) Office of Surface Mining Reclamation do so. 205–2000. The public version of the and Enforcement (OSM) is announcing This notice provides the public with complaint can be accessed on the its intention to request approval for the 60 days in which to comment on the Commission’s Electronic Document 1 collection of information for General following information collection Information System (EDIS) at EDIS, and Reclamation Requirements. activity: will be available for inspection during Title: 30 CFR Part 874—General official business hours (8:45 a.m. to 5:15 DATES: Comments on the proposed Reclamation Requirements. p.m.) in the Office of the Secretary, U.S. information collection must be received OMB Control Number: 1029–0113. International Trade Commission, 500 E by October 7, 2013, to be assured of Summary: Part 874 establishes land Street SW., Washington, DC 20436, consideration. and water eligibility requirements, telephone (202) 205–2000. ADDRESSES: Mail comments to John reclamation objectives and priorities Trelease, Office of Surface Mining and reclamation contractor 1 Electronic Document Information System Reclamation and Enforcement, 1951 responsibility. 30 CFR 874.17 requires (EDIS): http://edis.usitc.gov.

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General information concerning the United States, or United States treated accordingly. All nonconfidential Commission may also be obtained by consumers. written submissions will be available for accessing its Internet server at United In particular, the Commission is public inspection at the office of the States International Trade Commission interested in comments that: Secretary and on EDIS.5 (USITC) at USITC.2 The public record (i) Explain how the articles This action is taken under the for this investigation may be viewed on potentially subject to the requested authority of section 337 of the Tariff Act the Commission’s Electronic Document remedial orders are used in the United of 1930, as amended (19 U.S.C. 1337), Information System (EDIS) at EDIS.3 States; and of sections 201.10 and 210.8(c) of Hearing-impaired persons are advised (ii) identify any public health, safety, the Commission’s Rules of Practice and that information on this matter can be or welfare concerns in the United States Procedure (19 CFR 201.10, 210.8(c)). obtained by contacting the relating to the requested remedial Issued: August 2, 2013. Commission’s TDD terminal on (202) orders; By order of the Commission (iii) identify like or directly 205–1810. Lisa R. Barton, competitive articles that complainant, SUPPLEMENTARY INFORMATION: The its licensees, or third parties make in the Acting Secretary to the Commission. Commission has received a complaint United States which could replace the [FR Doc. 2013–19093 Filed 8–6–13; 8:45 am] and a submission pursuant to section subject articles if they were to be BILLING CODE 7020–02–P 210.8(b) of the Commission’s Rules of excluded; Practice and Procedure filed on behalf (iv) indicate whether complainant, of Spansion LLC on August 1, 2013. The complainant’s licensees, and/or third INTERNATIONAL TRADE complaint alleges violations of section party suppliers have the capacity to COMMISSION 337 of the Tariff Act of 1930 (19 U.S.C. replace the volume of articles [Docket No. 2970] 1337) in the importation into the United potentially subject to the requested States, the sale for importation, and the exclusion order and/or a cease and Certain Point-to-Point Network sale within the United States after desist order within a commercially Communication Devices and Products importation of certain flash memory reasonable time; and Containing Same; Notice of Receipt of chips and products containing the same. (v) explain how the requested Complaint; Solicitation of Comments The complaint names as respondents remedial orders would impact United Relating to the Public Interest Macronix International Co., Ltd. of States consumers. China; Macronix America, Inc. of CA; Written submissions must be filed no AGENCY: U.S. International Trade Macronix Asia Limited of Japan; later than by close of business, eight Commission. Macronix (Hong Kong) Co., Ltd. of Hong calendar days after the date of ACTION: Notice. Kong; Acer Inc. of Taiwan; Acer publication of this notice in the Federal America Corporation of CA; ASUSTek Register. There will be further SUMMARY: Notice is hereby given that Computer Inc. of Taiwan; Asus opportunities for comment on the the U.S. International Trade Computer International of CA; Belkin public interest after the issuance of any Commission has received a complaint International, Inc. of CA; D-Link final initial determination in this entitled Certain Point-to-Point Network Corporation of Taiwan; D-Link System, investigation. Communication Devices and Products Inc. of CA; Netgear Inc. of CA; Nintendo Persons filing written submissions Containing Same, DN 2970; the Co., Ltd. of Japan; and Nintendo of must file the original document Commission is soliciting comments on America, Inc. of WA. The complainant electronically on or before the deadlines any public interest issues raised by the requests that the Commission issue a stated above and submit 8 true paper complaint or complainant’s filing under general exclusion order or in the copies to the Office of the Secretary by section 210.8(b) of the Commission’s alternative issue a limited exclusion noon the next day pursuant to section Rules of Practice and Procedure (19 CFR order, cease and desist orders, and a 210.4(f) of the Commission’s Rules of 210.8(b)). bond upon respondents’ alleged Practice and Procedure (19 CFR FOR FURTHER INFORMATION CONTACT: Lisa infringing products during the 60-day 210.4(f)). Submissions should refer to R. Barton, Acting Secretary to the Presidential review period pursuant to the docket number (‘‘Docket No. 2971’’) Commission, U.S. International Trade 19 U.S.C. 1337(j). in a prominent place on the cover page Commission, 500 E Street, SW., Proposed respondents, other and/or the first page. (See Handbook for Washington, DC 20436, telephone (202) interested parties, and members of the Electronic Filing Procedures, Electronic 205–2000. The public version of the public are invited to file comments, not Filing Procedures 4). Persons with complaint can be accessed on the to exceed five (5) pages in length, questions regarding filing should Commission’s Electronic Document inclusive of attachments, on any public contact the Secretary (202–205–2000). Information System (EDIS) at EDIS,1 and interest issues raised by the complaint Any person desiring to submit a will be available for inspection during or section 210.8(b) filing. Comments document to the Commission in official business hours (8:45 a.m. to 5:15 should address whether issuance of the confidence must request confidential p.m.) in the Office of the Secretary, U.S. relief specifically requested by the treatment. All such requests should be International Trade Commission, 500 E complainant in this investigation would directed to the Secretary to the Street SW., Washington, DC 20436, affect the public health and welfare in Commission and must include a full telephone (202) 205–2000. the United States, competitive statement of the reasons why the General information concerning the conditions in the United States Commission should grant such Commission may also be obtained by economy, the production of like or treatment. See 19 CFR 201.6. Documents accessing its Internet server at United directly competitive articles in the for which confidential treatment by the States International Trade Commission Commission is properly sought will be 2 United States International Trade Commission 5 Electronic Document Information System (USITC): http://edis.usitc.gov. 4 Handbook for Electronic Filing Procedures: (EDIS): http://edis.usitc.gov. 3 Electronic Document Information System http://www.usitc.gov/secretary/fed_reg_notices/ 1 Electronic Document Information System (EDIS): http://edis.usitc.gov. rules/handbook_on_electronic_filing.pdf. (EDIS): http://edis.usitc.gov.

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(USITC) at USITC.2 The public record affect the public health and welfare in statement of the reasons why the for this investigation may be viewed on the United States, competitive Commission should grant such the Commission’s Electronic Document conditions in the United States treatment. See 19 CFR 201.6. Documents Information System (EDIS) at EDIS.3 economy, the production of like or for which confidential treatment by the Hearing-impaired persons are advised directly competitive articles in the Commission is properly sought will be that information on this matter can be United States, or United States treated accordingly. All nonconfidential obtained by contacting the consumers. written submissions will be available for Commission’s TDD terminal on (202) In particular, the Commission is public inspection at the Office of the 205–1810. interested in comments that: Secretary and on EDIS.5 SUPPLEMENTARY INFORMATION: The (i) Explain how the articles This action is taken under the Commission has received a complaint potentially subject to the requested authority of section 337 of the Tariff Act and a submission pursuant to section remedial orders are used in the United of 1930, as amended (19 U.S.C. 1337), 210.8(b) of the Commission’s Rules of States; and of sections 201.10 and 210.8(c) of Practice and Procedure filed on behalf (ii) identify any public health, safety, the Commission’s Rules of Practice and of Straight Path IP Group, Inc. on or welfare concerns in the United States Procedure (19 CFR 201.10, 210.8(c)). August 1, 2013. The complaint alleges relating to the requested remedial By order of the Commission. orders; violations of section 337 of the Tariff Issued: August 1, 2013. Act of 1930 (19 U.S.C. 1337) in the (iii) identify like or directly Lisa R. Barton, importation into the United States, the competitive articles that complainant, sale for importation, and the sale within its licensees, or third parties make in the Acting Secretary to the Commission. the United States after importation of United States which could replace the [FR Doc. 2013–18970 Filed 8–6–13; 8:45 am] certain point-to-point network subject articles if they were to be BILLING CODE 7020–02–P communication devices and products excluded; containing same. The complaint names (iv) indicate whether complainant, as respondents AmTran Logistics, Inc. complainant’s licensees, and/or third INTERNATIONAL TRADE of CA; AmTran Technology Co., Ltd. of party suppliers have the capacity to COMMISSION Taiwan; LG Electronics Inc. of Korea; replace the volume of articles [Investigation No. 337–TA–837] LG Electronics U.S.A., Inc. of NJ; LG potentially subject to the requested Electronics MobileComm U.S.A, Inc. of exclusion order and/or a cease and Certain Audiovisual Components and CA; Panasonic Corporation of Japan; desist order within a commercially Products Containing the Same Notice Panasonic Corporation of North reasonable time; and of Request for Statements on the America of NJ; Sharp Corporation of (v) explain how the requested Public Interest Japan; Sharp Electronics Corporation of remedial orders would impact United AGENCY: NJ; Sony Computer Entertainment, Inc. States consumers. U.S. International Trade of Japan; Sony Computer Entertainment Written submissions must be filed no Commission. America Inc. of CA; Sony Computer later than by close of business, eight ACTION: Notice. Entertainment America LLC of CA; Sony calendar days after the date of SUMMARY: Notice is hereby given that Corporation of Japan; Sony Corporation publication of this notice in the Federal the presiding administrative law judge of America of NY; Sony Electronics Inc. Register. There will be further has issued a Final Initial Determination of CA; Sony Mobile Communications opportunities for comment on the and Recommended Determination on AB of Sweden; Sony Mobile public interest after the issuance of any Remedy and Bonding in the above- Communications (USA) Inc. of NC; final initial determination in this captioned investigation. The Sony Ericsson Mobile Communications investigation. Commission is soliciting comments on (USA) Inc. of GA; Toshiba Corporation Persons filing written submissions public interest issues raised by the of Japan; Toshiba America Inc. of NY; must file the original document recommended relief, specifically a Toshiba America Information Systems, electronically on or before the deadlines limited exclusion order against certain Inc. of CA; Vizio, Inc. of CA. The stated above and submit 8 true paper infringing audiovisual components and complainant requests that the copies to the Office of the Secretary by products containing the same, imported Commission issue a limited exclusion noon the next day pursuant to section by Funai Corporation, Inc. of order, cease and desist orders, and a 210.4(f) of the Commission’s Rules of Rutherford, New Jersey; Funai Electric bond upon respondents’ alleged Practice and Procedure (19 CFR Co., Ltd. of Osaka, Japan; P&F USA, Inc. infringing products during the 60-day 210.4(f)). Submissions should refer to of Alpharetta, Georgia; and Funai Presidential review period pursuant to the docket number (‘‘Docket No. 2970’’) Service Corporation of Groveport, Ohio. 19 U.S.C. 1337(j). in a prominent place on the cover page This notice is soliciting public interest Proposed respondents, other and/or the first page. (See Handbook for comments from the public only. Parties interested parties, and members of the Electronic Filing Procedures, Electronic are to file public interest submissions public are invited to file comments, not Filing Procedures 4). Persons with pursuant to 19 CFR 210.50(a)(4). to exceed five (5) pages in length, questions regarding filing should inclusive of attachments, on any public contact the Secretary (202–205–2000). FOR FURTHER INFORMATION CONTACT: interest issues raised by the complaint Any person desiring to submit a Cathy Chen, Office of the General or section 210.8(b) filing. Comments document to the Commission in Counsel, U.S. International Trade should address whether issuance of the confidence must request confidential Commission, 500 E Street SW., relief specifically requested by the treatment. All such requests should be Washington, DC 20436, telephone (202) complainant in this investigation would directed to the Secretary to the 205–2392. The public version of the Commission and must include a full complaint can be accessed on the 2 United States International Trade Commission Commission’s electronic docket (EDIS) (USITC): http://edis.usitc.gov. 4 Handbook for Electronic Filing Procedures: 3 Electronic Document Information System http://www.usitc.gov/secretary/fed_reg_notices/ 5 Electronic Document Information System (EDIS): http://edis.usitc.gov. rules/handbook_on_electronic_filing.pdf. (EDIS): http://edis.usitc.gov.

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at http://edis.usitc.gov, and will be subject articles if they were to be INTERNATIONAL TRADE available for inspection during official excluded; COMMISSION business hours (8:45 a.m. to 5:15 p.m.) (iv) indicate whether complainant, Investigation No. 337–TA–880 in the Office of the Secretary, U.S. complainant’s licensees, and/or third International Trade Commission, 500 E party suppliers have the capacity to Certain Linear Actuators; Commission Street, SW., Washington, DC 20436, replace the volume of articles Determination Not To Review an Initial telephone (202) 205–2000. potentially subject to the recommended Determination Terminating the General information concerning the exclusion order and/or a cease and Investigation in Its Entirety Commission may also be obtained by desist order within a commercially AGENCY: U.S. International Trade accessing its Internet server (http:// reasonable time; and www.usitc.gov). The public record for Commission. this investigation may be viewed on the (v) explain how the limited exclusion ACTION: Notice. Commission’s electronic docket (EDIS) order would impact consumers in the at http://edis.usitc.gov. Hearing- United States. SUMMARY: Notice is hereby given that impaired persons are advised that Written submissions must be filed no the U.S. International Trade information on this matter can be later than by close of business on Commission has determined not to obtained by contacting the August 30, 2013. review the presiding administrative law judge’s (‘‘ALJ’’) initial determination Commission’s TDD terminal on (202) Persons filing written submissions 205–1810. (‘‘ID’’) (Order No. 6) terminating the must file the original document above-captioned investigation in its SUPPLEMENTARY INFORMATION: Section electronically on or before the deadlines entirety based on withdrawal of the 337 of the Tariff Act of 1930 provides stated above and submit 8 true paper complaint. that if the Commission finds a violation copies to the Office of the Secretary by it shall exclude the articles concerned noon the next day pursuant to section FOR FURTHER INFORMATION CONTACT: from the United States: 210.4(f) of the Commission’s Rules of Michael K. Haldenstein, Office of the General Counsel, U.S. International unless, after considering the effect of such Practice and Procedure (19 C.F.R. exclusion upon the public health and 210.4(f)). Submissions should refer to Trade Commission, 500 E Street SW., welfare, competitive conditions in the United the investigation number (‘‘Inv. No. Washington, DC 20436, telephone (202) States economy, the production of like or 837’’) in a prominent place on the cover 205–3041. Copies of non-confidential documents filed in connection with this directly competitive articles in the United page and/or the first page. (See States, and United States consumers, it finds investigation are or will be available for Handbook for Electronic Filing that such articles should not be excluded inspection during official business Procedures, http://www.usitc.gov/ from entry. hours (8:45 a.m. to 5:15 p.m.) in the secretary/fed_reg_notices/rules/ Office of the Secretary, U.S. 19 U.S.C. 1337(d)(1). A similar handbook_on_electronic_filing.pdf). International Trade Commission, 500 E provision applies to cease and desist Persons with questions regarding filing Street SW., Washington, DC 20436, orders. 19 U.S.C. 1337(f)(1). should contact the Secretary, (202) 205– telephone (202) 205–2000. General The Commission is interested in 2000. further development of the record on information concerning the Commission the public interest in these Any person desiring to submit a may also be obtained by accessing its investigations. Accordingly, members of document to the Commission in Internet server at http://www.usitc.gov. the public are invited to file confidence must request confidential The public record for this investigation submissions of no more than five (5) treatment. All such requests should be may be viewed on the Commission’s pages, inclusive of attachments, directed to the Secretary to the electronic docket (EDIS) at http:// concerning the public interest in light of Commission and must include a full edis.usitc.gov. Hearing-impaired the administrative law judge’s statement of the reasons why the persons are advised that information on Recommended Determination on Commission should grant such this matter can be obtained by Remedy and Bonding issued in this treatment. See 19 CFR 201.6. Documents contacting the Commission’s TDD investigation on July 31, 2013. for which confidential treatment by the terminal on (202) 205–1810. Comments should address whether Commission is properly sought will be SUPPLEMENTARY INFORMATION: The issuance of a limited exclusion order in treated accordingly. A redacted non- Commission instituted this investigation this investigation would affect the confidential version of the document on May 6, 2013, based on a complaint public health and welfare in the United must also be filed simultaneously with filed by Okin America, Inc. of Frederick, States, competitive conditions in the the any confidential filing. All non- Maryland and Dewert Okin GmbH of United States economy, the production confidential written submissions will be Germany (collectively, ‘‘Okin’’). 78 FR of like or directly competitive articles in available for public inspection at the 26393 (May 6, 2013). The complaint the United States, or United States Office of the Secretary and on EDIS. alleges violations of section 337 of the consumers. This action is taken under the Tariff Act of 1930, as amended (19 In particular, the Commission is authority of section 337 of the Tariff Act U.S.C. § 1337), in the importation into interested in comments that: of 1930, as amended (19 U.S.C. 1337), the United States, the sale for (i) Explain how the articles and of sections 201.10 and 210.50 of the importation, and the sale within the potentially subject to the recommended Commission’s Rules of Practice and United States after importation of orders are used in the United States; Procedure (19 CFR 201.10, 210.50). certain linear actuators by reason of (ii) identify any public health, safety, By order of the Commission. infringement of U.S. Patent No or welfare concerns in the United States Issued: August 1, 2013. 5,927,144. The complaint further alleges relating to the recommended orders; the existence of a domestic industry. (iii) identify like or directly Lisa R. Barton, The Commission’s notice of competitive articles that complainant, Acting Secretary to the Commission. investigation named Changzhou Kaidi its licensees, or third parties make in the [FR Doc. 2013–18964 Filed 8–6–13; 8:45 am] Electrical Co. Ltd. of China and Kaidi United States which could replace the BILLING CODE 7020–02–P LLC of Eaton Rapids, Michigan

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(collectively, ‘‘Kaidi’’) as the By order of the Commission. Department Web site: http:// respondents. The Office of Unfair Issued: August 1, 2013. www.usdoj.gov/enrd/ Import Investigation was named as a William R. Bishop, Consent_Decrees.html. We will provide participating party. Supervisory Hearings and Information a paper copy of the proposed Decree On June 27, 2013, Okin filed a motion Officer. upon written request and payment of to terminate the investigation in its [FR Doc. 2013–19155 Filed 8–5–13; 11:15 am] reproduction costs. Please mail your entirety based on withdrawal of the BILLING CODE 7020–02–P request and payment to: Consent Decree complaint. The motion stated that Kaidi Library, U.S. DOJ—ENRD, P.O. Box and the Commission investigative 7611, Washington, DC 20044–7611. attorney do not oppose the motion. On DEPARTMENT OF JUSTICE Please enclose a check or money order July 9, 2013, the ALJ issued the subject for $6.25 (.25 cents per page ID, granting Okin’s motion pursuant to Notice of Lodging of Consent Decree reproduction cost) payable to the United section 210.21(a)(1) of the Commission’s Under the Comprehensive States Treasury. Rules of Practice and Procedure (19 CFR Environmental Response, 210.21(a)(1)). No petitions for review of Compensation And Liability Act Robert Brook, this ID were filed. (‘‘CERCLA’’) Assistant Section Chief, Environmental The Commission has determined not Enforcement Section, Environment and to review the ID. Notice is hereby given that on August Natural Resources Division. The authority for the Commission’s 1, 2013, a proposed Consent Decree [FR Doc. 2013–19022 Filed 8–6–13; 8:45 am] determination is contained in section (‘‘proposed Decree’’) in United States v. BILLING CODE 4410–15–P 337 of the Tariff Act of 1930, as Richard Wilmer and Rock Weiss, Civil amended (19 U.S.C. 1337), and in Action No. 11–cv–02244–RM–MJW was section 210.42 of the Commission’s lodged with the United States District DEPARTMENT OF JUSTICE Court for the District of Colorado. Rules of Practice and Procedure (19 CFR Notice of Lodging of Proposed 210.42). In this action under Section 107(a) of the Comprehensive Environmental Consent Decree Under the By order of the Commission. Response, Compensation, and Liability Comprehensive Environmental Issued: August 1, 2013. Act, 42 U.S.C. 9607(a) (‘‘CERCLA’’), the Response, Compensation, and Liability Lisa R. Barton, United States sought reimbursement of Act Acting Secretary to the Commission. response costs incurred or to be On July 29, 2013 the Department of incurred for response actions taken at or [FR Doc. 2013–18971 Filed 8–6–13; 8:45 am] Justice lodged a proposed Consent in connection with the release or BILLING CODE 7020–02–P Decree with the United States District threatened release of hazardous Court for the Central District of substances at the Cherokee Street Print California in the lawsuit entitled United INTERNATIONAL TRADE Shop Wastes Superfund Site (‘‘Site’’) States v. Bentley Prince Street, Inc., COMMISSION located at 4411 Cherokee Street in Civil Action No. 13–cv–05455–CBM–JC. Denver, Colorado. The proposed Decree [USITC SE–13–017] requires Settling Defendant Rock Weiss The Consent Decree resolves claims to pay $600 to the United States in under Section 107 of the Government in the Sunshine Act Comprehensive Environmental Meeting Notice reimbursement of response costs. Settling Defendant Rock Weiss has an Response, Compensation, and Liability Act (‘‘CERCLA’’), 42 U.S.C. 9607 related AGENCY HOLDING THE MEETING: United inability to pay the United States’ full to releases and threatened releases of States International Trade Commission. demand. The publication of this notice opens hazardous substances at the Puente TIME AND DATE: August 9, 2013 at 11:00 Valley Operable Unit (‘‘PVOU’’) of the a.m. a period for public comment on the proposed Decree. Comments should be San Gabriel Valley Superfund Site, Area PLACE: Room 101, 500 E Street SW., addressed to the Assistant Attorney 4, Los Angeles County, California (the Washington, DC 20436, Telephone: General, Environment and Natural ‘‘Site’’). The Consent Decree resolves a (202) 205–2000. Resources Division, and should refer to claim against Bentley Prince Street, Inc., STATUS: Open to the public. United States v. Richard Wilmer, et al., (‘‘Bentley’’), and recovers $15,000 in MATTERS TO BE CONSIDERED: 1. Agendas D.J. Ref. No. 90–11–3–10179. All response costs. The Consent Decree for future meetings: none. comments must be submitted no later contains a covenant not to sue for past 2. Minutes. than thirty (30) days after the and certain future costs and response 3. Ratification List. publication date of this notice. work at the Site under Sections 106 and 4. Vote in Inv. Nos. 701–TA–498 and Comments may be submitted either by 107 of CERCLA and Section 7003 of 731–TA–1213–1214 (Preliminary) email or by mail: RCRA. (Certain Steel Threaded Rod from India The publication of this notice opens a period for public comment on the and Thailand). The Commission is To submit Send them to: currently scheduled to complete and file comments: Consent Decree. Comments should be its determinations on or before August addressed to the Assistant Attorney By e-mail ...... pubcomment- General, Environment and Natural 12, 2013; views of the Commission are [email protected]. currently scheduled to be completed By mail ...... Assistant Attorney General, Resources Division, and should refer to and filed on or before August 19, 2013. U.S. DOJ—ENRD, P.O. United States v. Bentley Prince Street, 5. Outstanding action jackets: none. Box 7611, Washington, DC Inc., D.J. Ref. No. 90–11–2–354/32. All In accordance with Commission 20044–7611. comments must be submitted no later policy, subject matter listed above, not than thirty (30) days after the disposed of at the scheduled meeting, During the public comment period, publication date of this notice. may be carried over to the agenda of the the proposed Decree may be examined Comments may be submitted either by following meeting. and downloaded at this Justice email or by mail:

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To submit Springfield, VA 22152, Telephone: (202) 2-(4-Iodo-2,5- comments: Send them to: 307–7165. dimethoxyphenyl)ethanamine (2C–I); 2- SUPPLEMENTARY INFORMATION: [4-(Ethylthio)-2,5- By e-mail ...... pubcomment- dimethoxyphenyl]ethanamine (2C–T–2); [email protected]. Background 2-[4-(Isopropylthio)-2,5- By mail ...... Assistant Attorney General, Section 306 of the CSA (21 U.S.C. dimethoxyphenyl]ethanamine (2C–T–4); U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 826) requires the Attorney General to 3,4-Methylenedioxymethamphetamine 20044–7611. establish aggregate production quotas (MDMA); 4-Anilino-N-phenethyl-4- for each basic class of controlled piperidine (ANPP); amphetamine (for Under section 7003(d) of RCRA, a substance listed in Schedules I and II sale); codeine (for conversion); commenter may request an opportunity and for ephedrine, pseudoephedrine, dihydromorphine; diphenoxylate (for for a public meeting in the affected area. and phenylpropanolamine. This sale); gamma hydroxybutyric acid; During the public comment period, responsibility has been delegated to the hydrocodone; hydromorphone; the Consent Decree may be examined Administrator of the DEA through 28 levomethorphan; methadone; and downloaded at this Justice CFR 0.100. The Administrator, in turn, methadone intermediate; Department Web site: http:// has redelegated this function to the methylphenidate; morphine (for www.usdoj.gov/enrd/ Deputy Administrator, pursuant to 28 conversion); morphine (for sale); Consent_Decrees.html. We will provide CFR 0.104. DEA published the 2013 oxycodone (for sale); oripavine; a paper copy of the Consent Decree established aggregate production quotas oxymorphone (for conversion); upon written request and payment of for controlled substances in Schedules I oxymorphone (for sale); phenylacetone; reproduction costs. Please mail your and II and assessment of annual needs and sufentanil were insufficient to request and payment to: Consent Decree for the List I chemicals ephedrine, provide for the estimated medical, Library, U.S. DOJ—ENRD, P.O. Box pseudoephedrine, and scientific, research, and industrial needs 7611, Washington, DC 20044–7611. phenylpropanolamine in the Federal of the United States, for export Please enclose a check or money order Register (77 FR 59980) on October 1, requirements, and for the establishment for $8.25 (25 cents per page 2012. That notice stated that the Deputy and maintenance of reserve stocks. One reproduction cost) payable to the United Administrator would adjust, as needed, manufacturer commented that the APQ States Treasury. the established aggregate production for thebaine was insufficient; however, quotas in 2013 as provided for in 21 that commenter was referring to a need Maureen M. Katz, CFR 1303.13 and 21 CFR 1315.13. The for procurement quota for thebaine, Assistant Section Chief, Environmental 2013 proposed adjusted aggregate which does not directly impact the APQ Enforcement Section, Environment and production quotas for controlled and, thus, was not considered. DEA did Natural Resources Division. substances in Schedules I and II and not previously propose adjustments to [FR Doc. 2013–19005 Filed 8–6–13; 8:45 am] assessment of annual needs for the List the 2013 assessment of annual needs for BILLING CODE 4410–15–P I chemicals ephedrine, ephedrine, pseudoephedrine, and pseudoephedrine, and phenylpropanolamine and received no phenylpropanolamine were comments concerning such. DEPARTMENT OF JUSTICE subsequently published in the Federal DEA has taken into consideration the Register on June 20, 2013, (78 FR 37237) above comments along with the relevant Drug Enforcement Administration in consideration of the outlined criteria. 2012 year-end inventories, initial 2013 [Docket No. DEA–365] All interested persons were invited to manufacturing quotas and import comment on or object to the proposed quotas, 2013 export requirements, actual Final Adjusted Aggregate Production adjusted aggregate production quotas and projected 2013 sales, research and Quotas for Schedule I and II Controlled and assessment of annual needs on or product development requirements, and Substances and Assessment of before July 22, 2013. additional applications received. Based Annual Needs for the List I Chemicals on all of the above, the Deputy Analysis for Final Adjusted 2013 Ephedrine, Pseudoephedrine, and Administrator has determined that the Aggregate Production Quotas and Phenylpropanolamine for 2013 proposed adjusted 2013 aggregate Assessment of Annual Needs production quotas and assessment of AGENCY: Drug Enforcement Consideration has been given to the annual needs for dihydromorphine; Administration (DEA), Department of criteria outlined in the June 20, 2013, diphenoxylate (for sale); gamma Justice. notice of proposed adjusted aggregate hydroxybutyric acid; hydromorphone; ACTION: Notice. production quotas and assessment of levomethorphan; morphine (for sale); annual needs, in accordance with 21 oxymorphone (for sale); phenylacetone; SUMMARY: This notice establishes final CFR 1303.13 and 21 CFR 1315.13. Six psilocyn; sufentanil; ephedrine (for adjusted 2013 aggregate production companies submitted timely comments quotas for controlled substances in sale); phenylpropanolamine (for regarding a total of 30 Schedule I and II conversion); and pseudoephedrine (for Schedules I and II of the Controlled controlled substances. Comments sale) required additional consideration Substances Act (CSA) and assessment of received proposed that the aggregate and hereby further adjusts the 2013 annual needs for the List I chemicals production quotas for 2-(2,5-Dimethoxy- aggregate production quotas for those ephedrine, pseudoephedrine, and 4-(n)-propylphenyl)ethanamine (2C–P); substances. phenylpropanolamine, as well as the 2-(2,5-Dimethoxy-4- Regarding 2-(2,5-Dimethoxy-4-(n)- 2013 aggregate production quotas for ethylphenyl)ethanamine (2C–E); 2-(2,5- propylphenyl)ethanamine (2C–P); 2- three recently temporarily controlled Dimethoxy-4-methylphenyl)ethanamine (2,5-Dimethoxy-4- substances. (2C–D); 2-(2,5-Dimethoxy-4-nitro- ethylphenyl)ethanamine (2C–E); 2-(2,5- FOR FURTHER INFORMATION CONTACT: John phenyl)ethanamine (2C–N); 2-(2,5- Dimethoxy-4-methylphenyl)ethanamine W. Partridge, Executive Assistant, Office Dimethoxyphenyl)ethanamine (2C–H); (2C–D); 2-(2,5-Dimethoxy-4-nitro- of Diversion Control, Drug Enforcement 2-(4-Chloro-2,5- phenyl)ethanamine (2C–N); 2-(2,5- Administration, 8701 Morrissette Drive, dimethoxyphenyl)ethanamine (2C–C); Dimethoxyphenyl)ethanamine (2C–H);

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2-(4-Chloro-2,5- industrial needs of the United States resulting adjusted established aggregate dimethoxyphenyl)ethanamine (2C–C); and to provide for adequate inventories. production quotas will reflect these 2-(4-Iodo-2,5- As described in the previously included amounts. This action will not dimethoxyphenyl)ethanamine (2C–I); 2- published notice establishing the 2013 affect the ability of manufacturers to [4-(Ethylthio)-2,5- aggregate production quotas and maintain inventory allowances as dimethoxyphenyl]ethanamine (2C–T–2); assessment of annual needs, DEA has specified by regulation. DEA expects 2-[4-(Isopropylthio)-2,5- specifically considered that inventory that maintaining this reserve in certain dimethoxyphenyl]ethanamine (2C–T–4); allowances granted to individual established aggregate production quotas manufacturers may not always result in 3,4-Methylenedioxymethamphetamine will mitigate adverse public effects if an the availability of sufficient quantities to (MDMA); 4-Anilino-N-phenethyl-4- unforeseen event resulted in substantial maintain an adequate reserve stock disruption to the amount of controlled piperidine (ANPP); amphetamine (for pursuant to 21 U.S.C. 826(a), as sale); codeine (for conversion); substances available to provide for intended. See 21 CFR 1303.24. This legitimate public need, as determined hydrocodone; methadone; methadone would be concerning if a natural by DEA. DEA does not anticipate intermediate; methylphenidate; disaster or other unforeseen event utilizing the reserve in the absence of morphine (for conversion); oxycodone resulted in substantial disruption to the these circumstances. (for sale); oripavine; and oxymorphone amount of controlled substances (for conversion), the Deputy available to provide for legitimate Pursuant to the above, the Deputy Administrator hereby determines that public need. As such, DEA has included Administrator hereby finalizes the 2013 the proposed adjusted 2013 aggregate in all proposed revised Schedule II aggregate production quotas for the production quotas and assessment of aggregate production quotas, and certain following Schedule I and II controlled annual needs for these substances and Schedule I aggregate production quotas, substances and the 2013 assessment of List I chemicals as published on June an additional 25% of the estimated annual needs for the List I chemicals 20, 2013, (78 FR 37237) are sufficient to medical, scientific, and research needs ephedrine, pseudoephedrine, and meet the current 2013 estimated as part of the amount necessary to phenylpropanolamine, expressed in medical, scientific, research, and ensure the establishment and grams of anhydrous acid or base, as maintenance of reserve stocks. The follows:

Final adjusted Basic class 2013 quotas

Temporarily Scheduled Substances

(1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR–144) ...... 15 g [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11) ...... 15 g N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48) ...... 15 g

Schedule I

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...... 45 g 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ...... 45 g 1-[1-(2-Thienyl)cyclohexyl]piperidine ...... 5 g 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ...... 45 g 1-Butyl-3-(1-naphthoyl)indole (JWH–073) ...... 45 g 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) ...... 45 g 1-Hexyl-3-(1-naphthoyl)indole (JWH–019) ...... 45 g 1-Methyl-4-phenyl-4-propionoxypiperidine ...... 2 g 1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ...... 45 g 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) ...... 45 g 1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) ...... 45 g 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) ...... 45 g 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) ...... 45 g 1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) ...... 45 g 1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) ...... 45 g 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P) ...... 15 g 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) ...... 15 g 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ...... 15 g 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ...... 15 g 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ...... 15 g 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ...... 15 g 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ...... 15 g 2,5-Dimethoxy-4-ethylamphetamine (DOET) ...... 12 g 2,5-Dimethoxy-4-n-propylthiophenethylamine ...... 12 g 2,5-Dimethoxyamphetamine ...... 12 g 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) ...... 15 g 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ...... 15 g 3,4,5-Trimethoxyamphetamine ...... 12 g 3,4-Methylenedioxyamphetamine (MDA) ...... 30 g 3,4-Methylenedioxymethamphetamine (MDMA) ...... 50 g 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ...... 24 g 3,4-Methylenedioxy-N-methylcathinone (methylone) ...... 35 g 3,4-Methylenedioxypyrovalerone (MDPV) ...... 25 g 3-Methylfentanyl ...... 2 g 3-Methylthiofentanyl ...... 2 g

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Final adjusted Basic class 2013 quotas

4-Bromo-2,5-dimethoxyamphetamine (DOB) ...... 12 g 4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ...... 12 g 4-Methoxyamphetamine ...... 88 g 4-Methyl-2,5-dimethoxyamphetamine (DOM) ...... 25 g 4-Methylaminorex ...... 12 g 4-Methyl-N-methylcathinone (mephedrone) ...... 25 g 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ...... 68 g 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47, 497 C8-homolog) ...... 53 g 5-Methoxy-3,4-methylenedioxyamphetamine ...... 12 g 5-Methoxy-N,N-diisopropyltryptamine ...... 12 g 5-Methoxy-N,N-dimethyltryptamine ...... 10 g Acetyl-alpha-methylfentanyl ...... 2 g Acetyldihydrocodeine ...... 2 g Acetylmethadol ...... 2 g Allylprodine ...... 2 g Alphacetylmethadol ...... 2 g Alpha-ethyltryptamine ...... 12 g Alphameprodine ...... 2 g Alphamethadol ...... 2 g Alpha-methylfentanyl ...... 2 g Alpha-methylthiofentanyl ...... 2 g Alpha-methyltryptamine (AMT) ...... 12 g Aminorex ...... 12 g Benzylmorphine ...... 2 g Betacetylmethadol ...... 2 g Beta-hydroxy-3-methylfentanyl ...... 2 g Beta-hydroxyfentanyl ...... 2 g Betameprodine ...... 2 g Betamethadol ...... 2 g Betaprodine ...... 2 g Bufotenine ...... 3 g Cathinone ...... 12 g Codeine-N-oxide ...... 602 g Desomorphine ...... 5 g Diethyltryptamine ...... 12 g Difenoxin ...... 50 g Dihydromorphine ...... 3,990,000 g Dimethyltryptamine ...... 18 g Gamma-hydroxybutyric acid ...... 67,500,000 g Heroin ...... 25 g Hydromorphinol ...... 54 g Hydroxypethidine ...... 2 g Ibogaine ...... 5 g Lysergic acid diethylamide (LSD) ...... 30 g Marihuana ...... 21,000 g Mescaline ...... 13 g Methaqualone ...... 10 g Methcathinone ...... 14 g Methyldihydromorphine ...... 2 g Morphine-N-oxide ...... 655 g N,N-Dimethylamphetamine ...... 12 g N-Benzylpiperazine ...... 15 g N-Ethylamphetamine ...... 12 g N-Hydroxy-3,4-methylenedioxyamphetamine ...... 12 g Noracymethadol ...... 2 g Norlevorphanol ...... 52 g Normethadone ...... 2 g Normorphine ...... 18 g Para-fluorofentanyl ...... 2 g Phenomorphan ...... 2 g Pholcodine ...... 2 g Properidine ...... 2 g Psilocybin ...... 10 g Psilocyn ...... 12 g Tetrahydrocannabinols ...... 491,000 g Thiofentanyl ...... 2 g Tilidine ...... 10 g Trimeperidine ...... 2 g

Schedule II

1-Phenylcyclohexylamine ...... 3 g 1-Piperdinocyclohexanecarbonitrile ...... 21 g

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Final adjusted Basic class 2013 quotas

4-Anilino-N-phenethyl-4-piperidine (ANPP) ...... 2,250,000 g Alfentanil ...... 38,250 g Alphaprodine ...... 3 g Amobarbital ...... 9 g Amphetamine (for conversion) ...... 22,875,000 g Amphetamine (for sale) ...... 47,186,000 g Carfentanil ...... 6 g Cocaine ...... 240,000 g Codeine (for conversion) ...... 81,250,000 g Codeine (for sale) ...... 49,506,250 g Dextropropoxyphene ...... 19 g Dihydrocodeine ...... 250,000 g Diphenoxylate ...... 887,500 g Ecgonine ...... 144,000 g Ethylmorphine ...... 3 g Fentanyl ...... 2,108,750 g Glutethimide ...... 3 g Hydrocodone (for sale) ...... 99,625,000 g Hydromorphone ...... 6,750,000 g Isomethadone ...... 5 g Levo-alphacetylmethadol (LAAM) ...... 4 g Levomethorphan ...... 195 g Levorphanol ...... 4,500 g Lisdexamfetamine ...... 21,000,000 g Meperidine ...... 6,875,000 g Meperidine Intermediate-A ...... 6 g Meperidine Intermediate-B ...... 11 g Meperidine Intermediate-C ...... 6 g Metazocine ...... 6 g Methadone (for sale) ...... 33,125,000 g Methadone Intermediate ...... 40,500,000 g Methamphetamine ...... 3,912,500 g

[987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,863,750 grams for methamphetamine mostly for conversion to a schedule III product; and 61,250 grams for methamphetamine (for sale)]

Methylphenidate ...... 96,750,000 g Morphine (for conversion) ...... 91,250,000 g Morphine (for sale) ...... 61,125,000 g Nabilone ...... 25,628 g Noroxymorphone (for conversion) ...... 9,000,000 g Noroxymorphone (for sale) ...... 1,262,500 g Opium (powder) ...... 91,250 g Opium (tincture) ...... 1,287,500 g Oripavine ...... 22,750,000 g Oxycodone (for conversion) ...... 10,250,000 g Oxycodone (for sale) ...... 153,750,000 g Oxymorphone (for conversion) ...... 18,375,000 g Oxymorphone (for sale) ...... 7,000,000 g Pentobarbital ...... 42,500,000 g Phenazocine ...... 6 g Phencyclidine ...... 30 g Phenmetrazine ...... 3 g Phenylacetone ...... 42,393,750 g Racemethorphan ...... 3 g Remifentanil ...... 3,750 g Secobarbital ...... 215,003 g Sufentanil ...... 6,880 g Tapentadol ...... 13,750,000 g Thebaine ...... 145,000,000 g

List I Chemicals

Ephedrine (for conversion) ...... 15,100,000 g Ephedrine (for sale) ...... 4,200,000 g Phenylpropanolamine (for conversion) ...... 44,800,000 g Phenylpropanolamine (for sale) ...... 6,100,000 g Pseudoephedrine (for sale) ...... 246,000,000 g

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Aggregate production quotas for all obtained by contacting the office listed Competition in Contracting Act and the other Schedule I and II controlled below in the addressee section of this Federal Acquisition Regulations. substances included in 21 CFR 1308.11 notice. The remaining 28 Job Corps centers, and 1308.12 remain at zero. DATES: Written comments must be called Civilian Conservation Centers, Dated: August 1, 2013. submitted to the office listed in the are operated by the U.S. Forest Service, Thomas M. Harrigan, addressee’s section below on or before via an interagency agreement. The Deputy Administrator. October 7, 2013. Department has a direct role in the operation of Job Corps, and does not [FR Doc. 2013–19046 Filed 8–6–13; 8:45 am] ADDRESSES: Submit written comments serve as a pass-through agency for this BILLING CODE 4410–09–P to Marcus Gray, Office of Job Corps, program. Room N–4463, Employment and Training Administration, U.S. II. Review Focus DEPARTMENT OF LABOR Department of Labor, 200 Constitution The Department is particularly Avenue NW., Washington, DC 20210. interested in comments which: Employment and Training Telephone number: 202–693–3967 (this Administration • Evaluate whether the proposed is not a toll-free number). Individuals collection of information is necessary Comment Request for Information with hearing or speech impairments for the proper performance of the Collection for Job Corps Placement may access the telephone number above agency’s function, including whether and Assistance Record, Extension via TTY by calling the toll-free Federal the information has practical utility; Information Relay Server at 877–889– Without Revisions • Evaluate the accuracy of the 5627 (TTY/TDD). Fax: 202–693–2767; agency’s estimate of the burden of the AGENCY: Employment and Training email: [email protected]. A copy of proposed collection of information, Administration (ETA), Labor. the proposed ICR can be obtained by including the validity of the ACTION: Notice. contacting the person listed above. methodology and assumptions used; SUPPLEMENTARY INFORMATION: SUMMARY: The Department of Labor • Enhance the quality, utility, and (Department), as part of its continuing I. Background clarity of the information to be effort to reduce paperwork and collected; and Job Corps is the nation’s largest respondent burden, conducts a pre- • Minimize the burden of the residential, educational, and career clearance consultation program to collection of information on those who technical training program for young provide the general public and Federal are to respond, by encouraging the use Americans. Job Corps was established in agencies with an opportunity to of appropriate automated, electronic, 1964 by the Economic Opportunity Act, comment on proposed and/or mechanical, or other technological and currently is authorized by Title I– continuing collections of information in collection techniques or other forms of C of the Workforce Investment Act of accordance with the Paperwork information technology, e.g., permitting 1998. Reduction Act of 1995 (PRA95) [44 electronic submissions of responses. U.S.C. 3506(c)(2)(A)]. This program For almost 50 years, Job Corps has helps ensure that requested data can be helped prepare a total of nearly 3 III. Current Actions provided in the desired format, million at-risk young people ages 16 to Type of Review: Extension 24 for success in our nation’s workforce. reporting burden (time and financial Title: Job Corps Placement Record resources) is minimized, collection With 125 centers in 48 states, Puerto Rico, and the District of Columbia, Job OMB Number: Control No. 1205–0035 instruments are clearly understood, and Affected Public: Individuals or the impact of collection requirements on Corps assists students across the nation in attaining academic credentials, Households (Job Corps students) and respondents can be properly assessed. Private Sector—(Job Corps centers) Currently, ETA is soliciting comments including a High School Diploma (HSD) concerning the collection of data about and/or High School Equivalency Form(s): ETA 678 Job Corps Placement Record [OMB credential, and career technical training, Total Annual Respondents: 34,000 Control No. 1205–0035, expires January including industry-recognized Annual Frequency: Once (when 2014]: ETA 678 form, Job Corps credentials, state licensures, and pre- placement occurs) Placement and Assistance Record. ETA apprenticeship credentials. Total Annual Responses: 34,000 form 678 currently captures information Job Corps is administered by the Average Time per Response: 7.43 about a student’s training and Department through the Office of Job minutes subsequent placement in a job, higher Corps and six Regional Offices. The Estimated Total Annual Burden education or the military, as well as the Department awards and administers Hours: 4,210 name of the placement provider agency. contracts for the recruiting and Total Annual Other Burden Costs for Data generated from the form ETA 678 screening of new students, center Respondents: $0 is used to evaluate overall placement operations, and the placement and Comments submitted in response to outcomes. This form is critical to the transitional support of graduates and this comment request will be program’s evaluation process. It is the former enrollees. Large and small summarized and included in the request only form which documents a student’s corporations and nonprofit for Office of Management and Budget post-center placement status. This form organizations manage and operate 97 approval of the information collection is completed by either a Job Corps Job Corps centers under contractual request; they will also become a matter center records staff or a Career agreements with the Department. These of public record. Transition Specialist for each student. contract Center Operators are selected Dated: July 31, 2013. Job Corps is not proposing any changes through a competitive procurement to ETA 678 form, Job Corps Placement process that evaluates potential Eric M. Seleznow, Record. operators’ technical expertise, proposed Acting Assistant Secretary. A copy of the proposed Information costs, past performance, and other [FR Doc. 2013–19061 Filed 8–6–13; 8:45 am] Collection Request (ICR) can be factors, in accordance with the BILLING CODE 4510–FT–P

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DEPARTMENT OF LABOR Washington, DC 20210. Telephone educators, economic developers, and numbers 202–693–2784 or 202–693– others. Employment and Training 3755, respectively (these are not toll-free The addition to the currently Administration numbers). Individuals with hearing or approved information collection is to speech impairments may access the request that states submit their annual Comment Request for Information telephone numbers above via TTY by narrative progress reports on grant Collection for Workforce Information calling the toll-free Federal Information deliverables electronically using a Grants to States, Extension With Relay Service at 1–877–889–5627 (TTY/ reporting system that will allow DOL Revisions TDD). Fax: 202–693–3015. Email: and the states to mine the reported data AGENCY: Employment and Training [email protected] or to identify successful practices, trends, Administration (ETA), Labor. [email protected], respectively. A challenges, and suggestions for ACTION: Notice. copy of the proposed information improvement. collection request (ICR) can be obtained SUMMARY: The U.S. Department of Labor by contacting the office listed above or II. Review Focus (Department), as part of its continuing at the Labor Market Information WIN– The Department is particularly effort to reduce paperwork and WIN Network Community of Practice interested in comments which: respondent burden, conducts a Web site (https:// • Evaluate whether the proposed preclearance consultation program to winwin.workforce3one.org/view/ collection of information is necessary provide the public and Federal agencies 1001317540353607180/info). for the proper performance of the with an opportunity to comment on SUPPLEMENTARY INFORMATION: functions of the agency, including proposed and/or continuing collections I. Background whether the information will have of information in accordance with the practical utility; Paperwork Reduction Act (PRA) of 1995 On July 24, 2011, OMB approved • Evaluate the accuracy of the [44 U.S.C. 3506(c)(2)(A)]. This program ETA’s annual policy guidance and agency’s estimate of the burden of the helps ensure that requested data can be application instructions for the proposed collection of information, provided in the desired format, Workforce Information Grants to States including the validity of the reporting burden (time and financial under OMB Control Number 1205–0417. methodology and assumptions used; resources) is minimized, collection ETA now requests OMB approval to • Enhance the quality, utility, and instruments are clearly understood, and make a change to this information clarity of the information to be the impact of collection requirements on collection. The purpose of this respondents can be properly assessed. collected; and information collection is to comply with • Currently, ETA is soliciting comments the Workforce Investment Act (WIA) Minimize the burden of the concerning the collection of data about Public Law 105–220, Sections 111(d)(8) collection of information on those who the Workforce Information Grants to and 309 (29 U.S.C. 2821(d)(8) and are to respond, including through the States (WIGS), U.S. Office of 49(l)(2), to maximize the use of use of appropriate automated, Management and Budget (OMB) Control workforce and economic information in electronic, mechanical, or other Number 1205–0417 that expires on July employment and training programs and technological collection techniques or 31, 2014. ETA is requesting an addition other activities at the state and local other forms of information technology, to the collection requirements for these level. The data and workforce e.g., permitting electronic submissions data, as well as requesting a three year information services provided through of responses. extension. WIGS support the development of data- III. Current Actions DATES: Written comments must be driven policy, inform training and Type of Review: Extension with submitted to the office listed in the employment program design and revision. addresses section below on or before investment decision-making, support October 7, 2013. consultations with strategic partners, Title: Workforce Information Grants to ADDRESSES: Submit written comments and leverage limited labor market States. to Anthony Dais or Frank Gallo, Office information-workforce information OMB Number: 1205–0417. of Workforce Investment, Room C–4526, (LMI–WI) program grant resources. State Affected Public: States and Employment and Training workforce agencies use WIGS to develop Territories. Administration, U.S. Department of and disseminate essential state and local Form(s): N/A. Labor, 200 Constitution Avenue NW., LMI–WI for job seekers, employers, Total Annual Respondents: 54.

Average time Data collection activity Number of re- Responses per response spondents per year (hours)

Required economic report or analyses ...... 54 1 434 Annual report to ETA ...... 54 1 80 New annual reporting system ...... 54 1 1

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Total Annual Other Burden Cost for the program. The objective of the study 303(a)(5) of the Social Security Act and Respondents: 0. is to understand employers’ awareness Section 3304(a)(4) of the Federal Comments submitted in response to and perceptions of the STC program, Unemployment Tax Act, STC benefits this comment request will be including how various elements of the may be paid from monies available in summarized and/or included in the program affect their interest and the Unemployment Trust Fund. Each request for OMB approval of the ICR; participation. State has an account within the Fund they will also become a matter of public DATES: Written comments must be from which it pays benefits. Currently, record. submitted to the office listed in the 25 States and the District of Columbia Dated: July 25, 2013. addresses section below on or before have STC provisions in their UI laws. Eric M. Seleznow, October 7, 2013. The proposed study will examine employers’ experiences, awareness, and Acting Assistant Secretary for Employment ADDRESSES: Submit written comments and Training, Labor. to Gloribel Nieves-Cartagena, Office of perspectives of the STC Program in Kansas, Minnesota, Rhode Island, and [FR Doc. 2013–19059 Filed 8–6–13; 8:45 am] Policy Development and Research, Washington. Each of these four States BILLING CODE 4510–FN–P Room N5641, Employment and Training Administration, U.S. Department of has an active STC program. Employers Labor, 200 Constitution Avenue NW., in these four States who have used the DEPARTMENT OF LABOR Washington, DC 20210. Telephone STC Program, as well as employers in number: 202–693–2771 (this is not a these four States who have not used the Employment and Training toll-free number). Individuals with program, will be surveyed. The study Administration hearing or speech impairments may will focus on the following four research access the telephone number above via areas: Comment Request for Information TTY by calling the toll-free Federal (1) Characteristics of employers Collection for Employers Survey of the Information Relay Service at 1–877– participating in the STC Program. Short-Time Compensation Program 889–5627 (TTY/TDD). Fax: 202–693– (2) Extent of employer participation in (STC); New Collection 2766. Email: nieves- the STC Program. (3) Employers’ awareness, [email protected]. A copy of AGENCY: Employment and Training experiences, and views of the STC the proposed information collection Administration, Labor. Program. request (ICR) with applicable supporting ACTION: Notice. (4) Employers’ opinion about workers documentation; including a description view of STC. SUMMARY: The Department of Labor, as of likely respondents, proposed Addressing these research areas will part of its continuing effort to reduce frequency of responses, and estimated involve analyses of survey data as well paperwork and respondent burden, total burden can be obtained free of as analyses of relevant UI administrative conducts a pre-clearance consultation charge by contacting the office listed data and employer survey data. UI program to provide the public and above. administrative data and employer Federal agencies with an opportunity to SUPPLEMENTARY INFORMATION: survey data will be used to gain comment on proposed and/or I. Background knowledge about the employer’s continuing collections of information in awareness and experience with the STC accordance with the Paperwork In February 2012, the Middle Class Program and to examine the factors Reduction Act of 1995 (PRA) [44 U.S.C. Tax Relief and Job Creation Act of 2012, related to the employer’s decision to 3505(c)(2)(A)]. PRA helps to ensure that was signed into law. Section 2164 apply. The results of the analyses will requested data can be provided in the requires the Secretary of Labor to survey help to assess whether there are desired format, reporting burden (time employers in all States to determine significant differences in the likelihood and financial resources) is minimized, their level of interest in participating in of participation across employer collection instruments are clearly the STC Program. The proposed characteristics. understood, and the impact of the information collection is a preliminary collection requirements on respondents step in support of complying with the II. Review Focus can be properly assessed. 50-state survey requirement of Section The Department is particularly Currently, the Employment and 2164, and ETA is seeking approval to interested in comments which: Training Administration (ETA) is collect survey data from employers in • Evaluate whether the proposed soliciting comments concerning the four States with active STC. collection of information is necessary collection of survey data from The STC Program, also known as for the proper performance of the employers in a sub-set of states that ‘‘work sharing’’ or ‘‘shared work’’, functions of the agency, including operate a STC Program. The STC provides an opportunity for employers whether the information will have Program provides an opportunity for to reduce layoffs by temporarily practical utility; employers to reduce layoffs by reducing work hours of some • Evaluate the accuracy of the temporarily reducing work hours for employees. STC provides pro-rated agency’s estimate of the burden of the some employees. STC provides pro- unemployment insurance (UI) benefits proposed collection of information, rated unemployment insurance benefits for workers whose hours of work have including the validity of the for workers whose hours of work have been temporarily reduced. The U.S. methodology and assumptions used; been temporarily reduced. The program was first initiated in California • Enhance the quality, utility, and proposed information collection is to in 1978 and a temporary national STC clarity of the information to be examine employers’ experiences, Program was adopted in 1982 under the collected; and awareness, and perspectives of the STC Tax Equity and Fiscal Responsibility • Minimize the burden of the Program in Kansas, Minnesota, Rhode Act (Pub. L. 97–248). The STC Program collection of information on those who Island, and Washington, through became permanent in Federal law in are to respond, including through the surveying the employers in these four 1992, when States were permitted to use of appropriate automated, States who have used the STC program, adopt their own STC programs as part electronic, mechanical, or other as well as employers who have not used of State UI laws. Under Section technological collection techniques or

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other forms of information technology, III. Current Actions OMB Number: 1205–0NEW. e.g., permitting electronic submissions Type of Review: New Collection. Affected Public: Private Sector, of responses. Title: Employers Survey of Short- Employers. Time Compensation Program.

Average time Data Collection Activity Total Frequency Total re- per respond- Burden (hours) respondents sponses ent

Employer Survey of Short-Time Compensation ...... 3,200 Once ...... 3,200 27 minutes .. 1,440

Total Annual other Burden Cost for directed by the Antarctic Conservation Location Respondents: $0. Act of 1978 (Pub. L. 95–541), as Comments submitted in response to amended by the Antarctic Science, Western Antarctic Peninsula Region. this comment request will be Tourism and Conservation Act of 1996, Dates summarized and included in the request has developed regulations for the for Office of Management and Budget establishment of a permit system for Dates permit valid: November 1, 2013 approval of the ICR; they will also various activities in Antarctica and to March 31, 2017. become a matter of public record. designation of certain animals and Nadene G. Kennedy, certain geographic areas a requiring Dated: July 31, 2013. Division of Polar Programs. Eric M. Seleznow, special protection. The regulations establish such a permit system to [FR Doc. 2013–19035 Filed 8–6–13; 8:45 am] Acting Assistant Secretary for Employment BILLING CODE 7555–01–P and Training, Labor. designate Antarctic Specially Protected Areas. [FR Doc. 2013–19063 Filed 8–6–13; 8:45 am] BILLING CODE 4510–FN–P Application Details: NATIONAL SCIENCE FOUNDATION Permit Application: 2014–006 Advisory Committee for Environmental Research and Education; Notice of NATIONAL SCIENCE FOUNDATION 1. Applicant: Eric Stangeland, Quark Meeting Expeditions. Notice of Permit Applications Received Under the Antarctic Conservation Act Applicant Address: Quark In accordance with the Federal of 1978 (Pub. L. 95–541) Expeditions Inc., 93 Pilgrim Park, Suite Advisory Committee Act (Public Law 1 Waterbury, VT 05676. 92–463, as amended), the National AGENCY: National Science Foundation. Science Foundation announces the Activity for Which Permit Is Requested ACTION: Notice of Waste Permit following meeting: Applications Received Under the Waste Permit; Quark expeditions is Name: Advisory Committee for Antarctic Conservation Act of 1978, planning to operate three vessels which Environmental Research and Education, Pub. L. 95–541. will conduct tourist landings in the #9487. Antarctic. Each vessel will complete Dates: September 11, 2013, 9:00 a.m.–5:00 SUMMARY: The National Science p.m., and September 12, 2013, 9:00 a.m.–2:00 Foundation (NSF) is required to publish multiple cruises and multiple landings per cruise. Activities on shore include p.m. a notice of permit applications received Place: Stafford I, Room 1235, National to conduct activities regulated under the zodiac landings to visit wildlife, historic Science Foundation, 4201 Wilson Blvd., Antarctic Conservation Act of 1978. sites and research stations. Maximum Arlington, Virginia 22230. NSF has published regulations under passengers taken ashore at any one time Type of Meeting: Open. the Antarctic Conservation Act at Title will be limited to 100 persons. On Contact Person: Beth Zelenski, National 45 Part 671 of the Code of Federal selected voyages Quark plans to offer: Science Foundation, Suite 705, 4201 Wilson (1) Guided excursions by kayak to Blvd., Arlington, Virginia 22230. Phone 703– Regulations. This is the required notice 292–8500. of permit applications received. suitably experienced and fit passengers, (2) the opportunity for a limited number To help facilitate your entry into the DATES: Interested parties are invited to of people to remain on shore to enjoy building, contact Beth Zelenski submit written data, comments, or ([email protected]). Your request should be the polar night (3) the opportunity for a received on or prior to September 9, 2013. views with respect to this permit limited number of people to cross application by September 6, 2013. This Minutes: May be obtained from the contact country ski at one or more specially person listed above. application may be inspected by selected locations (4) the opportunity interested parties at the Permit Office, Purpose of Meeting: To provide advice, for a limited number of people to recommendations, and oversight concerning address below. downhill ski at one or more specially support for environmental research and ADDRESSES: Comments should be selected locations 5) the opportunity for education. addressed to Permit Office, Room 755, a limited number of reasonably fit Agenda Division of Polar Programs, National people to participate in ice climbing and Science Foundation, 4201 Wilson mountaineering. No grey water, food September 11, 2013 Boulevard, Arlington, Virginia 22230. waste or any garbage or solid waste • Update on NSF environmental research FOR FURTHER INFORMATION CONTACT: and education activities and collaborations would be brought or generated ashore • Adrian Dahood, ACA Permit Officer, at during the course of the described Meeting with NSF Senior Leadership and Acting Director, Dr. Cora Marrett the above address or activities. All human waste generated [email protected] or (703) 292–7149. ashore would be contained and returned September 12, 2013 SUPPLEMENTARY INFORMATION: The to the ship for storage and eventual • Discussion on urban sustainability issues National Science Foundation, as proper disposal outside of the Antarctic. • Discussion on NSF merit review criteria

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Dated: August 2, 2013. Applicant Address SUMMARY: The U.S. Nuclear Regulatory Susanne Bolton, Hubbs-SeaWorld Research Institute, Commission (NRC) is issuing the Final Committee Management Officer. 2595 Ingraham Street, San Diego, Japan Lessons-Learned Project Directorate Interim Staff Guidance (JLD– [FR Doc. 2013–19092 Filed 8–6–13; 8:45 am] California, 92109. ISG), JLD–ISG–2013–01, ‘‘Guidance for BILLING CODE 7555–01–P Activity for Which Permit Is Requested Estimating Flooding hazards due to Dam Harmful Interference/Take. This Failure’’ (Agencywide Documents NATIONAL SCIENCE FOUNDATION application is to allow for the un- Access and Management System intentional and unexpected brief, minor (ADAMS) Accession No. Notice of Permit Applications Received disturbance to Antarctic birds and ML13151A153). This ISG provides Under the Antarctic Conservation Act marine mammals at breeding, molting, guidance and clarification to assist of 1978 (Pub. L. 95–541) and terrestrial, fast-ice, and sea-ice haul- nuclear power reactors applicants and out sites at various sub-Antarctic licensees with the flooding hazard AGENCY: National Science Foundation. (within geographic coverage area of the reassessment in response to Enclosure 2 Antarctic Treaty) and Antarctic of the NRC staff’s request for ACTION: Notice of Permit Applications locations during observational research information, ‘‘Request for Information Received under the Antarctic to document several aspects of acoustic Pursuant to section 50.54(f) of Title 10 Conservation Act of 1978, Public Law and non-acoustic behavior and ecology. of the Code of Federal Regulations (10 95–541. Research would be conducted using CFR), Regarding Recommendations 2.1, remote-controlled aerial platforms (i.e., 2.3, and 9.3 of the Near-Term Task SUMMARY: The National Science quad-copters and hex-copters) equipped Force Review of Insights from the Foundation (NSF) is required to publish with small high-resolution cameras to Fukushima Dai-ichi Accident,’’ dated a notice of permit applications received document distribution, dispersion, March 12, 2012 (ADAMS Accession No. to conduct activities regulated under the habitat use, and abundance of seals and ML12053A340). Antarctic Conservation Act of 1978. seabirds whenever conditions permit. ADDRESSES: Please refer to Docket ID NSF has published regulations under These aerial sorties will be launched at NRC–2013–0073 when contacting the the Antarctic Conservation Act at Title least 50 to 100m from any wildlife NRC about the availability of 45 Part 670 of the Code of Federal should not be detectable visually or information regarding this document. Regulations. This is the required notice acoustically by wildlife during their You may access information related to of permit applications received. operation. Flight altitudes would be 100 this document, which the NRC DATES: Interested parties are invited to m or higher. Photographs and audio possesses and are publicly-available, submit written data, comments, or recordings also would be collected on using any of the following methods: • Federal Rulemaking Web site: Go to views with respect to this permit the ground. No Antarctic Specially http://www.regulations.gov and search application by September 6, 2013. This Protected Areas (ASPA) would be for Docket ID NRC–2013–0073. Address application may be inspected by entered in pursuit of this research. questions about NRC dockets to Carol interested parties at the Permit Office, Research locations would be accessed Gallagher; telephone: 301–287–3442; address below. from tour ships as part of their pre- scheduled landings and is therefore email: [email protected]. ADDRESSES: Comments should be focused on visitor sites. • NRC’s Agencywide Documents addressed to Permit Office, Room 755, Access and Management System Division of Polar Programs, National Location (ADAMS): You may access publicly- Science Foundation, 4201 Wilson Western Antarctic Peninsula region available documents online in the NRC Boulevard, Arlington, Virginia 22230. visitor sites. Library at http://www.nrc.gov/reading- rm/adams.html. To begin the search, FOR FURTHER INFORMATION CONTACT: Dates select ‘‘ADAMS Public Documents’’ and Adrian Dahood, ACA Permit Officer, at Dates permit valid: October 1, 2013 to then select ‘‘Begin Web-based ADAMS the above address or October 1, 2018. Search.’’ For problems with ADAMS, [email protected] or (703) 292–7149. please contact the NRC’s Public Nadene G. Kennedy, SUPPLEMENTAL INFORMATION: The Document Room (PDR) reference staff at Division of Polar Programs. National Science Foundation, as 1–800–397–4209, 301–415–4737, or by directed by the Antarctic Conservation [FR Doc. 2013–19034 Filed 8–6–13; 8:45 am] email to [email protected]. The Act of 1978 (Pub. L. 95–541), as BILLING CODE 7555–01–P JLD–ISG–2013–01 is available under amended by the Antarctic Science, ADAMS Accession No. ML13151A153. • Tourism and Conservation Act of 1996, NRC’s PDR: You may examine and has developed regulations for the NUCLEAR REGULATORY purchase copies of public documents at establishment of a permit system for COMMISSION the NRC’s PDR, Room O1–F21, One various activities in Antarctica and White Flint North, 11555 Rockville designation of certain animals and [NRC–2013–0073] Pike, Rockville, MD 20852. • certain geographic areas a requiring NRC’s Interim Staff Guidance Web Japan Lessons-Learned Project special protection. The regulations site: Go to http://www.nrc.gov/reading- Directorate Interim Staff Guidance establish such a permit system to rm/doc-collections/isg/japan-lessons- JLD–ISG–2013–01; Guidance for designate Antarctic Specially Protected learned.html and refer to JLD–ISG– Estimating Flooding Hazards Due to Areas. 2013–01. Dam Failure FOR FURTHER INFORMATION CONTACT: Mr. Application Details AGENCY: Nuclear Regulatory G. Edward Miller, Japan Lessons- Permit Application: 2014–005 Commission. Learned Project Directorate, Office of Nuclear Reactor Regulation, U.S. ACTION: Interim staff guidance; issuance. 1. Applicant: Brent Stewart. Nuclear Regulatory Commission,

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Washington, DC 20555–0001; telephone: Term Task Force (NTTF). The NTTF 12, 2012. The letter dated March 12, 301–415–2481; email: was tasked with conducting a 2012, includes a request that licensees [email protected]. systematic and methodical review of the reevaluate flooding hazards at nuclear SUPPLEMENTARY INFORMATION: NRC’s regulations and processes, and power plant sites using updated determining if the agency should make flooding hazard information and Background Information additional improvements to these present-day regulatory guidance and The NRC staff developed JLD–ISG– programs in light of the events at methodologies. The letter also requests 2013–01 to provide guidance and Fukushima Dai-ichi. As a result of this the comparison of the reevaluated clarification to assist nuclear power review, the NTTF developed a hazard to the current design basis at the reactor licensees, applicants for power comprehensive set of recommendations, site for each potential flood mechanism. reactor licenses, and holders of documented in SECY–11–0093, ‘‘Near- If the reevaluated flood hazard at a site construction permits in active or Term Report and Recommendations for is not bounded by the current design deferred status with the evaluation of Agency Actions Following the Events in basis, licensees are requested to perform flooding hazards due to dam failure. Japan,’’ dated July 12, 2011 (ADAMS an integrated assessment. The integrated On March 11, 2011, a magnitude 9.0 Accession No. ML11186A950). These assessment will evaluate the total plant earthquake struck off the coast of the recommendations were enhanced by the response to the flood hazard, Japanese island of Honshu. The NRC staff following interactions with considering multiple and diverse earthquake resulted in a large tsunami, stakeholders. Documentation of the capabilities such as physical barriers, estimated to have exceeded 14 meters staff’s efforts is contained in SECY–11– temporary protective measures, and (45 feet) in height, that inundated the 0124, ‘‘Recommended Actions to be operational procedures. The NRC staff Fukushima Dai-ichi nuclear power plant Taken Without Delay from the Near- will review the licensees’ responses to site. The earthquake and tsunami Term Task Force Report,’’ dated this request for information and produced widespread devastation across September 9, 2011 (ADAMS Accession determine whether regulatory actions No. ML11245A158), and SECY–11– northeastern Japan and significantly are necessary to provide additional 0137, ‘‘Prioritization of Recommended affected the infrastructure and industry protection against flooding. Actions to be Taken in Response to in the northeastern coastal areas of Numerous public meetings were held Fukushima Lessons Learned,’’ dated Japan. When the earthquake occurred, to receive stakeholder input on the October 3, 2011 (ADAMS Accession No. Fukushima Dai-ichi Units 1, 2, and 3 proposed guidance prior to its issuance ML11272A111). formally for public comment. On April were in operation and Units 4, 5, and 6 As directed by the Commission’s staff 25, 2013 (78 FR 24439), the NRC were shut down for routine refueling requirements memorandum (SRM) for requested public comments on draft and maintenance activities. The Unit 4 SECY–11–0093, dated August 19, 2011 JLD–ISG–2013–01. In public meetings reactor fuel was offloaded to the Unit 4 (ADAMS Accession No. ML112310021), on May 2, 2013, and May 22, 2013, the spent fuel pool. Following the the NRC staff reviewed the NTTF earthquake, the three operating units recommendations within the context of NRC staff interacted extensively with automatically shut down and offsite the NRC’s existing regulatory framework external stakeholders to discuss, power was lost to the entire facility. The and considered the various regulatory understand, and resolve public emergency diesel generators (EDG) vehicles available to the NRC to comments. Modifications were made to started at all six units providing implement the recommendations. the text of the ISG in response to the alternating current (ac) electrical power SECY–11–0124 and SECY–11–0137 public comments and the outcomes of to critical systems at each unit. The established the staff’s prioritization of the public meetings. Full detail of the facility response to the earthquake the recommendations based upon the comments, staff responses, and the appears to have been normal. potential for each recommendation to staff’s bases for changes to the ISG are Approximately 40 minutes following enhance safety. contained in ‘‘NRC Response to Public the earthquake and shutdown of the As part of the SRM for SECY–11– Comments’’ to JLD–ISG–2013–01, which operating units, however, the first large 0124, dated October 18, 2011, the can be found under ADAMS Accession tsunami wave inundated the site, Commission approved the staff’s No. ML13151A161. followed by additional waves. The proposed actions, including the Backfitting and Issue Finality tsunami caused extensive damage to site development of three information facilities and resulted in a complete loss requests under 10 CFR 50.54(f). The This ISG does not constitute of all ac electrical power at Units 1 information collected would be used to backfitting as defined in 10 CFR 50.109 through 5, a condition known as station support the NRC staff’s evaluation of (the Backfit Rule) and is not otherwise blackout. In addition, all direct current whether further regulatory action was inconsistent with the issue finality electrical power was lost early in the needed in the areas of seismic and provisions in 10 CFR part 52, ‘‘Licenses, event on Units 1 and 2, and after some flooding design and emergency Certifications, and Approvals for period of time at the other units. Unit preparedness. Nuclear Power Plants.’’ This ISG 6 retained the function of one air-cooled In addition to Commission direction, provides guidance on an acceptable EDG. Despite their actions, the operators the Consolidated Appropriations Act, method for implementing the March 12, lost the ability to cool the fuel in the Public Law 112–074, was signed into 2012, request for information. Neither Unit 1 reactor after several hours, in the law on December 23, 2011. Section 402 the information request nor the ISG Unit 2 reactor after about 70 hours, and of the law directs the NRC to require require the modification or addition to in the Unit 3 reactor after about 36 licensees to reevaluate their design basis systems, structures, or components, or hours, resulting in damage to the for external hazards. design of a facility. Applicants and nuclear fuel shortly after the loss of In response to the aforementioned licensees may voluntarily use the cooling capabilities. Commission and Congressional guidance in JLD–ISG–2013–01 to Following the events at the direction, the NRC issued a request for comply with the request for Fukushima Dai-ichi nuclear power information to all power reactor information. The information received plant, the NRC established a senior-level licensees and holders of construction by this request may, at a later date, be agency task force referred to as the Near- permits under 10 CFR part 50 on March used in the basis for imposing a backfit.

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The appropriate backfit review process accompanied or preceded by an LTP to For The Nuclear Regulatory Commission. would be followed at that time. be submitted for NRC approval. Pacific Bruce Watson, Congressional Review Act Gas and Electric submitted the proposed Branch Chief, Reactor Decommissioning LTP for HBPP with a license Branch, Decommissioning and Uranium This interim staff guidance is a rule as amendment application dated May 3, Recovery Licensing Directorate, Division of designated in the Congressional Review 2013. The LTP would be approved by Waste Management and Environmental Protection, Office of Federal and State Act (5 U.S.C. 801–808). OMB has found license amendment if found acceptable that this is not a major rule in Materials and Environmental Management by the NRC staff. The amendment accordance with the Congressional Programs. would be subject to such conditions and Review Act. [FR Doc. 2013–19054 Filed 8–6–13; 8:45 am] limitations as the NRC staff deems BILLING CODE 7590–01–P Dated at Rockville, Maryland, this 29th day appropriate and necessary. In of July 2013. For The Nuclear Regulatory Commission. accordance with 10 CFR 20.1405 and 10 CFR 50.82(a)(9)(iii), the NRC is NUCLEAR REGULATORY David L. Skeen, providing notice to individuals in the COMMISSION Director, Japan Lessons-Learned Project vicinity of the site that the NRC: (1) Is Directorate, Office of Nuclear Reactor Sunshine Federal Register Notice Regulation. in receipt of the HBPP LTP; (2) will hold a public meeting: and (3) will accept [FR Doc. 2013–19057 Filed 8–6–13; 8:45 am] AGENCY HOLDING THE MEETINGS: Nuclear comments from affected parties. BILLING CODE 7590–01–P Regulatory Commission [NRC–2013– The HBPP LTP is available for public 0001]. viewing at the NRC’s Public Document DATES: Week of August 5, 2013. NUCLEAR REGULATORY Room (PDR) or electronically through PLACE: Commissioners’ Conference COMMISSION the NRC Agencywide Documents Room, 11555 Rockville Pike, Rockville, [DOCKET NO. 50–133; NRC–2013–0130] Access and Management System Maryland. (ADAMS) at accession numbers STATUS: Public and Closed. Pacific Gas and Electric Company, ML131300009 and ML131300160. Humboldt Bay Power Plant, Unit 3, Documents may be examined, and/or Week of August 5, 2013 Notice of Public Meeting on the copied for a fee, at the PDR, located at Monday, August 5, 2013 License Termination Plan One White Flint North, 11555 Rockville 1:00 p.m. Affirmation Session (Public AGENCY: Nuclear Regulatory Pike (first floor), Rockville, Maryland. Meeting) (Tentative). Commission. Publicly available records will be Proposed Commission Order in ACTION: Application for license accessible electronically from the Response to Decision by D.C. amendment; public meeting. ADAMS Public Library component on Circuit in Shieldalloy Metallurgical the NRC Web site, http://www.nrc.gov. Corp. v. NRC (Tentative). SUMMARY: The U.S. Nuclear Regulatory Persons who do not have access to Commission (NRC) is providing notice * * * * * ADAMS or who encounter problems in *The schedule for Commission that the NRC staff will conduct a accessing the documents located in meetings is subject to change on short meeting to discuss and accept public ADAMS should contact the NRC PDR notice. To verify the status of meetings, comments on the Humboldt Bay Power Reference staff by telephone at 1–800– call (recording)—301–415–1292. Plant (HBPP), Unit 3 License 397–4209, or 301–415–4737, or by email Contact person for more information: Termination Plan (LTP) on Tuesday, at [email protected]. Rochelle Bavol, 301–415–1651. August 20, 2013, at 6:00 p.m. in the Great Room at the Warfinger Building, Any meeting updates or changes will * * * * * Eureka Public Marina, #1 Marina Way, be made available on the NRC’s Public Additional Information Eureka, California. Meeting Schedule Web site at http:// The HBPP is located about four miles www.nrc.gov/public-involve/public- By a vote of 5–0 on August 2, 2013, southwest of the city of Eureka, meetings/. the Commission determined pursuant to Humboldt County, California and U.S.C. 552b(e) and § 9.107(a) of the FOR FURTHER INFORMATION CONTACT: consists of 143 acres of land. Unit 3, Commission’s rules that the above which is the NRC licensed reactor, is Comments or questions regarding the referenced Affirmation Session be held currently being decommissioned with HBPP LTP or the public meeting may be with less than one week notice to the the spent fuel now stored in the onsite addressed to Mr. John B. Hickman, Mail public. The meeting is scheduled on Independent Spent Fuel Storage Stop T–8–F5, Office of Federal and State August 5, 2013. Installation. Unit 3 decommissioning Materials and Environmental * * * * * commenced in May 2009. Following the Management Programs, U.S. Nuclear The NRC Commission Meeting start of a new power generation facility Regulatory Commission, Washington, Schedule can be found on the Internet in 2010, the licensee commenced with DC 20555–0001, telephone 301–415– at: http://www.nrc.gov/public-involve/ the permanent shutdown of the fossil 3017 or via email public-meetings/schedule.html. Units 1 and 2. Units 1 and 2 are being [email protected]. * * * * * decommissioned in conjunction with Dated at Rockville, Maryland, this 30th day The NRC provides reasonable Unit 3 decommissioning. of July 2013. accommodation to individuals with In accordance with the NRC disabilities where appropriate. If you regulations at § 50.82(a)(9) of Title 10 of need a reasonable accommodation to the Code of Federal Regulations (10 participate in these public meetings, or CFR), all power reactor licensees must need this meeting notice or the submit an application for termination of transcript or other information from the their license. The application for public meetings in another format (e.g. termination of license must be braille, large print), please notify

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Kimberly Meyer, NRC Disability (44 U.S.C. 3501 et seq.), the Securities other forms of information technology. Program Manager, at 301–287–0727, or and Exchange Commission Consideration will be given to by email at kimberly.meyer- (‘‘Commission’’) is soliciting comments comments and suggestions submitted in [email protected]. Determinations on on the existing collection of information writing within 60 days of this requests for reasonable accommodation provided for in Rule 17a–1 (17 CFR publication. will be made on a case-by-case basis. 240.17a–1) under the Securities An agency may not conduct or * * * * * Exchange Act of 1934, as amended (the sponsor, and a person is not required to This notice is distributed ‘‘Act’’) (15 U.S.C. 78a et seq.). The respond to, a collection of information electronically to subscribers. If you no Commission plans to submit this unless it displays a currently valid OMB longer wish to receive it, or would like existing collection of information to the control number. to be added to the distribution, please Office of Management and Budget for Please direct your written comments contact the Office of the Secretary, extension and approval. to: Thomas Bayer, Director/Chief Washington, DC 20555 (301–415–1969), Rule 17a–1 requires that every Information Officer, Securities and or send an email to national securities exchange, national Exchange Commission, c/o Remi Pavlik- [email protected]. securities association, registered Simon, 100 F St. NE., Washington, DC clearing agency, and the Municipal 20549 or send an email to: Dated: August 2, 2013. Securities Rulemaking Board keep on [email protected]. Rochelle C. Bavol, file for a period of not less than five Dated: August 1, 2013. Policy Coordinator, Office of the Secretary. years, the first two years in an easily Kevin M. O’Neill, [FR Doc. 2013–19171 Filed 8–5–13; 4:15 pm] accessible place, at least one copy of all Deputy Secretary. BILLING CODE 7590–01–P documents, including all correspondence, memoranda, papers, [FR Doc. 2013–19041 Filed 8–6–13; 8:45 am] books, notices, accounts, and other such BILLING CODE 8011–01–P OVERSEAS PRIVATE INVESTMENT records made or received by it in the CORPORATION course of its business as such and in the conduct of its self-regulatory activity, SECURITIES AND EXCHANGE COMMISSION Sunshine Act Notice; Special Meetings and that such documents be available of the Board of Directors for examination by the Commission. There are 28 entities required to Proposed Collection; Comment Request TIME AND DATES: Wednesday, August 14, comply with the rule: 17 national 2013, 3 p.m. Monday, August 19, 2013. securities exchanges, 1 national Upon Written Request, Copies Available (CLOSED) securities association, 9 registered From: Securities and Exchange PLACE: Offices of the Corporation, 1100 clearing agencies, and the Municipal Commission, Office of Investor New York Avenue NW., Washington, Securities Rulemaking Board. The Education and Advocacy, DC. Commission staff estimates that the Washington, DC 20549–0213. average number of hours necessary for STATUS: Meetings will commence at 3 compliance with the requirements of Extension: p.m. (approx.). Rule 15Ba2–5, SEC File No. 270–91, OMB Rule 17a–1 is 50 hours per year. In Control No. 3235–0088. MATTER TO BE CONSIDERED: 1. Insurance addition, 5 national securities Project—Egypt. exchanges notice-registered pursuant to Notice is hereby given that pursuant CONTACT PERSON FOR INFORMATION: Section 6(g) of the Act (15 U.S.C. 78f(g)) to the Paperwork Reduction Act of 1995 Information on the meetings may be are required to preserve records of (44 U.S.C. 3501 et seq.), the Securities obtained from Connie M. Downs at (202) determinations made under Rule 3a55– and Exchange Commission 336–8438. 1 under the Act (17 CFR 240.3a55–1), (‘‘Commission’’) is soliciting comments on the collection of information August 5, 2013. which the Commission staff estimates will take 1 hour per exchange, for a total provided for in Rule 15Ba2–5 (17 CFR Connie M. Downs, of 5 hours. Accordingly, the 240.15Ba2–5)—Registration of Corporate Secretary, Overseas Private Commission staff estimates that the total Fiduciaries, under the Securities Investment Corporation. number of hours necessary to comply Exchange Act of 1934 (15 U.S.C. 78a et [FR Doc. 2013–19207 Filed 8–5–13; 4:15 pm] with the requirements of Rule 17a–1 is seq.) (the ‘‘Exchange Act’’). The BILLING CODE 3210–01–P 1,405 hours. The average cost per hour Commission plans to submit this is $63. Therefore, the total cost of existing collection of information to the compliance for all respondents is Office of Management and Budget for SECURITIES AND EXCHANGE $88,515. extension and approval. COMMISSION Written comments are invited on (a) On July 7, 1976, effective July 16, whether the proposed collection of 1976 (see 41 FR 28948, July 14, 1976), Proposed Collection; Comment information is necessary for the proper the Commission adopted Rule 15Ba2–5 Request performance of the functions of the under the Exchange Act of 1934 to Commission, including whether the permit a duly-appointed fiduciary to Upon Written Request, Copies Available information shall have practical utility; assume immediate responsibility for the From: Securities and Exchange (b) the accuracy of the Commission’s operation of a municipal securities Commission, Office of Investor estimate of the burden of the proposed dealer’s business. Without the rule, the Education and Advocacy, collection of information; (c) ways to fiduciary would not be able to assume Washington, DC 20549–0213. enhance the quality, utility, and clarity operation until it registered as a Extension: of the information to be collected; and municipal securities dealer. Under the Rule 17a–1; SEC File No. 270–244, OMB (d) ways to minimize the burden of the rule, the registration of a municipal Control No. 3235–0208. collection of information on securities dealer is deemed to be the Notice is hereby given that, pursuant respondents, including through the use registration of any executor, to the Paperwork Reduction Act of 1995 of automated collection techniques or administrator, guardian, conservator,

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assignee for the benefit of creditors, SECURITIES AND EXCHANGE the nature of the writer’s interest, the receiver, trustee in insolvency or COMMISSION reason for the request, and the issues bankruptcy, or other fiduciary, contested. Persons who wish to be [Investment Company Act Release No. notified of a hearing may request appointed or qualified by order, 30639; 812–14071] judgment, or decree of a court of notification by writing to the competent jurisdiction to continue the Ranger Alternative Management, L.P. Commission’s Secretary. business of such municipal securities and Ranger Funds Investment Trust; ADDRESSES: Elizabeth M. Murphy, dealer, provided that such fiduciary Notice of Application Secretary, U.S. Securities and Exchange files with the Commission, within 30 Commission, 100 F Street NE., days after entering upon the August 1, 2013. Washington, DC 20549–1090. performance of his duties, a statement AGENCY: Securities and Exchange Applicants: 2828 N. Harwood Street, setting forth as to such fiduciary Commission (‘‘Commission’’). Suite 1600, Dallas, Texas 75201. substantially the same information ACTION: Notice of an application for an FOR FURTHER INFORMATION CONTACT: required by Form MSD or Form BD. The order under section 6(c) of the Steven I. Amchan, Senior Counsel, at statement is necessary to ensure that the Investment Company Act of 1940 (202) 551–6826 or Jennifer L. Sawin, Commission and the public have (‘‘Act’’) for an exemption from sections Branch Chief, at (202) 551–6821 adequate information about the 2(a)(32), 5(a)(1), 22(d) and 22(e) of the (Division of Investment Management, fiduciary. Act and rule 22c-1 under the Act, under Exemptive Applications Office). sections 6(c) and 17(b) of the Act for an There is approximately 1 respondent SUPPLEMENTARY INFORMATION: The exemption from sections 17(a)(1) and per year that requires an aggregate total following is a summary of the (a)(2) of the Act, and under section of 4 hours to comply with this rule. This application. The complete application 12(d)(1)(J) of the Act for an exemption respondent makes an estimated 1 may be obtained via the Commission’s from sections 12(d)(1)(A) and (B) of the annual response. Each response takes Web site by searching for the file Act. approximately 4 hours to complete. number, or an applicant using the Company name box, at http:// Thus, the total compliance burden per APPLICANTS: Ranger Alternative year is 4 burden hours. The approximate www.sec.gov/search/search.htm or by Management, L.P. (‘‘Ranger’’) and calling (202) 551–8090. cost per hour is $20, resulting in a total Ranger Funds Investment Trust (the cost of compliance for the respondent of ‘‘Trust’’). Applicants’ Representations approximately $80 (i.e., 4 hours x $20). SUMMARY OF APPLICATION: Applicants 1. The Trust is registered as an open- Written comments are invited on: (a) request an order that permits: (a) end management investment company Whether the proposed collection of Actively-managed series of certain under the Act and is a statutory trust information is necessary for the proper open-end management investment organized under the laws of Delaware. performance of the functions of the companies to issue shares (‘‘Shares’’) The Trust initially will offer one series, Commission, including whether the redeemable in large aggregations only the Ranger Global ETF (the ‘‘Initial information shall have practical utility; (‘‘Creation Units’’); (b) secondary market Fund’’), which applicants state will seek (b) the accuracy of the Commission’s transactions in Shares to occur at long term capital appreciation through estimates of the burden of the proposed negotiated market prices; (c) certain long positions and short sales (‘‘Short collection of information; (c) ways to series to pay redemption proceeds, Positions’’) of U.S. and/or non-U.S. enhance the quality, utility, and clarity under certain circumstances, more than equity securities. of the information to be collected; and seven days from the tender of Shares for 2. Ranger, a Texas limited (d) ways to minimize the burden of the redemption; (d) certain affiliated partnership, is registered as an collection of information on persons of the series to deposit investment adviser under the respondents, including through the use securities into, and receive securities Investment Advisers Act of 1940 of automated collection techniques or from, the series in connection with the (‘‘Advisers Act’’) and will serve as other forms of information technology. purchase and redemption of Creation investment adviser to the Initial Fund. Consideration will be given to Units; and (e) certain registered The Advisor (as defined below) may in comments and suggestions submitted in management investment companies and the future retain one or more sub- writing within 60 days of this unit investment trusts outside of the advisers (each a ‘‘Subadvisor’’) to publication. same group of investment companies as manage the portfolios of the Funds (as An agency may not conduct or the series to acquire Shares. defined below). Any Subadvisor will be sponsor, and a person is not required to DATES: Filing Dates: The application was registered under the Advisers Act or not respond to, a collection of information filed on August 24, 2012, and amended subject to such registration. A registered under the PRA unless it displays a on March 5, 2013, and July 30, 2013. broker-dealer under the Securities Exchange Act of 1934 (‘‘Exchange Act,’’ currently valid OMB control number. HEARING OR NOTIFICATION OF HEARING: and such persons registered under the Please direct your written comments to: An order granting the requested relief Exchange Act, ‘‘Brokers’’), which may Thomas Bayer, Director/Chief will be issued unless the Commission be an affiliate of the Advisor, will act as Information Officer, Securities and orders a hearing. Interested persons may the distributor and principal Exchange Commission, c/o Remi Pavlik- request a hearing by writing to the underwriter of the Funds Simon, 100 F Street, NE., Washington, Commission’s Secretary and serving (‘‘Distributor’’).1 DC 20549 or send an email to: applicants with a copy of the request, 3. Applicants request that the order [email protected]. personally or by mail. Hearing requests apply to the Initial Fund and any future should be received by the Commission Dated: August 1, 2013. series of the Trust or future series of by 5:30 p.m. on August 26, 2013, and other existing or future open-end Kevin M. O’Neill, should be accompanied by proof of Deputy Secretary. service on applicants, in the form of an 1 Applicants request that the order also apply to [FR Doc. 2013–19038 Filed 8–6–13; 8:45 am] affidavit or, for lawyers, a certificate of future distributors that comply with the terms and BILLING CODE 8011–01–P service. Hearing requests should state conditions of the application.

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management companies that are ‘‘Investing Funds’’). Investing Funds do (including cash positions),8 except: (a) exchange-traded funds (‘‘ETFs’’) and not include the Funds.5 In the case of bonds, for minor that utilize active management 5. Applicants anticipate that a differences when it is impossible to investment strategies (‘‘Future Funds’’). Creation Unit will consist of at least break up bonds beyond certain Any Future Fund will (a) be advised by 25,000 Shares and that the price of a minimum sizes needed for transfer and Ranger or an entity controlling, Share will range from $10 to $100. All settlement; (b) for minor differences controlled by, or under common control orders to purchase Creation Units must when rounding is necessary to eliminate with Ranger (each, an ‘‘Advisor’’), and be placed with the Distributor by or fractional shares or lots that are not 9 (b) comply with the terms and through a party that has entered into a tradeable round lots; or (c) TBA 2 10 conditions of the application. The participant agreement with the Transactions, Short Positions and Initial Fund and Future Funds together Distributor and the transfer agent of the other positions that cannot be 11 are the ‘‘Funds’’. Each Fund will consist Fund (‘‘Authorized Participant’’) with transferred in kind will be excluded 12 of a portfolio of securities (including respect to the creation and redemption from the Creation Basket. If there is a fixed income securities and/or equity of Creation Units. An Authorized difference between the NAV attributable securities) and/or currencies, other Participant is either: (a) A Broker or to a Creation Unit and the aggregate assets, and other positions of the Fund other participant in the Continuous Net market value of the Creation Basket 3 (‘‘Portfolio Positions’’). Funds may Settlement System of the National exchanged for the Creation Unit, the 4 invest in ‘‘Depositary Receipts.’’ Each Securities Clearing Corporation party conveying instruments with the Fund will operate as an actively (‘‘NSCC’’), a clearing agency registered lower value will also pay to the other an managed ETF. The Funds may invest in with the Commission and affiliated with amount in cash equal to that difference other open-end and/or closed-end the Depository Trust Company (‘‘DTC’’), (the ‘‘Balancing Amount’’). 7. Purchases and redemptions of investment companies and/or ETFs. or (b) a participant in the DTC (such Creation Units may be made in whole or 4. Applicants also request that any participant, ‘‘DTC Participant’’). exemption under section 12(d)(1)(J) of in part on a cash basis, rather than in the Act from sections 12(d)(1)(A) and 6. In order to keep costs low and kind, solely under the following (B) apply to: (i) Any Fund that is permit each Fund to be as fully invested circumstances: (a) To the extent there is currently or subsequently part of the as possible, Shares will be purchased a Balancing Amount, as described same ‘‘group of investment companies’’ and redeemed in Creation Units and, to above; (b) if, on a given Business Day, as the Initial Fund within the meaning the extent practicable, on an in-kind a Fund announces before the open of of section 12(d)(1)(G)(ii) of the Act; (ii) basis. Accordingly, except where the trading that all purchases, all any principal underwriter for the Fund; purchase or redemption will include redemptions or all purchases and (iii) any Brokers selling Shares of a cash under the limited circumstances redemptions on that day will be made Fund to an Investing Fund (as defined specified below, purchasers will entirely in cash; (c) if, upon receiving a below); and (iv) each management generally be required to purchase purchase or redemption order from an investment company or unit investment Creation Units by making an in-kind Authorized Participant, a Fund trust registered under the Act that is not deposit of specified instruments determines to require the purchase or part of the same ‘‘group of investment (‘‘Deposit Instruments’’), and redemption, as applicable, to be made companies’’ as the Funds within the shareholders redeeming their Shares entirely in cash; (d) if, on a given meaning of section 12(d)(1)(G)(ii) of the will receive an in-kind transfer of Business Day, a Fund requires all Act and that enters into a FOF specified instruments (‘‘Redemption Authorized Participants purchasing or 6 Participation Agreement (as defined Instruments’’). On any given Business redeeming Shares on that day to deposit 7 below) with a Fund (such management Day, the names and quantities of the or receive (as applicable) cash in lieu of investment companies, ‘‘Investing instruments that constitute the Deposit some or all of the Deposit Instruments Management Companies,’’ such unit Instruments and the names and or Redemption Instruments, investment trusts, ‘‘Investing Trusts,’’ quantities of the instruments that respectively, solely because: (i) Such and Investing Management Companies constitute the Redemption Instruments instruments are not eligible for transfer and Investing Trusts together, will be identical, and these instruments through either the NSCC or DTC; or (ii) may be referred to, in the case of either in the case of Funds holding non-U.S. 2 Any Advisor to a Future Fund will be registered a purchase or redemption, as the investment (‘‘Global Funds’’), such as an investment adviser under the Advisers Act. ‘‘Creation Basket.’’ In addition, the instruments are not eligible for trading All entities that currently intend to rely on the Creation Basket will correspond pro rata due to local trading restrictions, local order are named as applicants. Any other entity that to the positions in a Fund’s portfolio restrictions on securities transfers or relies on the order in the future will comply with the terms and conditions of the application. 8 3 If a Fund invests in derivatives, then (a) the 5 An Investing Fund may rely on the order only The portfolio used for this purpose will be the board of trustees (‘‘Board’’) of the Fund will to invest in Funds and not in any other registered same portfolio used to calculate the Fund’s net asset periodically review and approve the Fund’s use of investment company. value (‘‘NAV’’) for that Business Day. derivatives and how the Advisor assesses and 6 The Funds must comply with the federal 9 A tradeable round lot for a security will be the manages risk with respect to the Fund’s use of securities laws in accepting Deposit Instruments standard unit of trading in that particular type of derivatives, and (b) the Fund’s disclosure of its use and satisfying redemptions with Redemption security in its primary market. of derivatives in its offering documents and Instruments, including that the Deposit Instruments 10 A TBA Transaction is a method of trading periodic reports will be consistent with relevant and Redemption Instruments are sold in mortgage-backed securities. In a TBA Transaction, Commission and staff guidance. transactions that would be exempt from registration the buyer and seller agree on general trade 4 Depositary Receipts are typically issued by a under the Securities Act of 1933 (‘‘Securities Act’’). parameters such as agency, settlement date, par financial institution, a ‘‘depositary’’, and evidence In accepting Deposit Instruments and satisfying amount and price. ownership in a security or pool of securities that redemptions with Redemption Instruments that are 11 This includes instruments that can be have been deposited with the depositary. A Fund restricted securities eligible for resale pursuant to transferred in kind only with the consent of the will not invest in any Depositary Receipts that the Rule 144A under the Securities Act, the Funds will original counterparty to the extent the Fund does Advisor or Subadvisor deems to be illiquid or for comply with the conditions of Rule 144A. not intend to seek such consents. which pricing information is not readily available. 7 Each Fund will sell and redeem Creation Units 12 Because these instruments will be excluded No affiliated persons of applicants, any Future on any day the Fund is open for business, including from the Creation Basket, their value will be Fund or any Subadvisor will serve as the depositary as required by section 22(e) of the Act (each, a reflected in the determination of the Balancing bank for any Depositary Receipts held by a Fund. ‘‘Business Day’’). Amount (defined below).

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other similar circumstances; or (e) if a purchase Creation Units will be placed not trade at a material discount or Fund permits an Authorized Participant with the Distributor by or through an premium in relation to their NAV. to deposit or receive (as applicable) cash Authorized Participant and the 12. Shares will not be individually in lieu of some or all of the Deposit Distributor will transmit all purchase redeemable and owners of Shares may Instruments or Redemption Instruments, orders to the relevant Fund. The acquire those Shares from a Fund, or respectively, solely because: (i) Such Distributor will be responsible for tender such shares for redemption to the instruments are, in the case of the delivering a prospectus (‘‘Prospectus’’) Fund, in Creation Units only. To purchase of a Creation Unit, not to those persons purchasing Creation redeem, an investor must accumulate available in sufficient quantity; (ii) such Units and for maintaining records of enough Shares to constitute a Creation instruments are not eligible for trading both the orders placed with it and the Unit. Redemption requests must be by an Authorized Participant or the confirmations of acceptance furnished placed by or through an Authorized investor on whose behalf the by it. Participant. Authorized Participant is acting; or (iii) 13. Neither the Trust nor any Fund a holder of Shares of a Global Fund 10. Shares will be listed and traded at will be marketed or otherwise held out would be subject to unfavorable income negotiated prices on a Stock Exchange as a ‘‘mutual fund.’’ Instead, each Fund tax treatment if the holder receives and traded in the secondary market. will be marketed as an ‘‘actively- redemption proceeds in kind.13 Applicants expect that Stock Exchange managed exchange-traded fund.’’ In any 8. Each Business Day, before the open specialists (‘‘Specialists’’) or market advertising material where features of of trading on a national securities makers (‘‘Market Makers’’) will be obtaining, buying or selling Creation exchange, as defined in section 2(a)(26) assigned to Shares. The price of Shares Units or Shares are described, or where of the Act (‘‘Stock Exchange’’), on which trading on the Stock Exchange will be there is reference to redeemability, there Shares are listed, each Fund will cause based on a current bid/offer in the will be an appropriate statement to the to be published through the NSCC the secondary market. Transactions effect that Shares are not individually names and quantities of the instruments involving the purchases and sales of redeemable. comprising the Creation Basket, as well Shares on the Stock Exchange will be 14. The Funds’ Web site, which will as the estimated Balancing Amount (if subject to customary brokerage be publicly available prior to the public any), for that day. The published commissions and charges. offering of Shares, will include a Creation Basket will apply until a new 11. Applicants expect that purchasers Prospectus and additional quantitative Creation Basket is announced on the of Creation Units will include information updated on a daily basis, following Business Day, and there will including, on a per Share basis for each be no intra-day changes to the Creation institutional investors and arbitrageurs. Specialists or Market Makers, acting in Fund, the prior Business Day’s NAV and Basket except to correct errors in the the market closing price or mid-point of published Creation Basket. The Stock their unique role to provide a fair and orderly secondary market for Shares, the bid/ask spread at the time of the Exchange will disseminate every 15 calculation of such NAV (‘‘Bid/Ask also may purchase Creation Units for seconds throughout the trading day Price’’), and a calculation of the use in their own market making through the facilities of the premium or discount of the market activities.15 Applicants expect that Consolidated Tape Association an closing price or Bid/Ask Price against secondary market purchasers of Shares amount representing the estimated such NAV. On each Business Day, NAV, on a per Share basis, which will will include both institutional and retail 16 before commencement of trading in be the sum of the current value of the investors. Applicants expect that Shares on the Stock Exchange, the Fund Portfolio Positions that were publicly arbitrage opportunities created by the will disclose on its Web site the disclosed prior to the commencement of ability to continually purchase or identities and quantities of the Portfolio trading in Shares on the Stock redeem Creation Units at their NAV per Positions held by the Fund that will Exchange. Share should ensure that the Shares will form the basis for the Fund’s calculation 9. A Fund may recoup the settlement of NAV at the end of the Business Day.17 costs charged by NSCC and DTC by investment companies offering redeemable imposing a transaction fee on investors securities. Applicants’ Legal Analysis purchasing or redeeming Creation Units 15 If Shares are listed on NYSE Arca, Nasdaq or a similar electronic Stock Exchange, one or more 1. Applicants request an order under (the ‘‘Transaction Fee’’). The member firms of that Stock Exchange will act as section 6(c) of the Act for an exemption Transaction Fee will be borne only by Market Maker and maintain a market for Shares from sections 2(a)(32), 5(a)(1), 22(d) and purchasers and redeemers of Creation trading on the Stock Exchange. On Nasdaq, no 22(e) of the Act and rule 22c–1 under Units and will be limited to amounts particular Market Maker would be contractually obligated to make a market in Shares. However, the the Act, under sections 6(c) and 17(b) of that have been determined appropriate listing requirements on Nasdaq, for example, the Act for an exemption from sections by the Advisor to defray the transaction stipulate that at least two Market Makers must be 17(a)(1) and 17(a)(2) of the Act, and expenses that will be incurred by a registered in Shares to maintain a listing. In under section 12(d)(1)(J) of the Act for Fund when an investor purchases or addition, on Nasdaq and NYSE Arca, registered an exemption from sections 12(d)(1)(A) 14 Market Makers are required to make a continuous redeems Creation Units. All orders to two-sided market or subject themselves to and (B) of the Act. regulatory sanctions. If Shares are listed on a Stock 2. Section 6(c) of the Act provides that 13 A ‘‘custom order’’ is any purchase or Exchange such as the NYSE, one or more member the Commission may exempt any redemption of Shares made in whole or in part on firms will be designated to act as a Specialist and person, security or transaction, or any a cash basis in reliance on clause (e)(i) or (e)(ii). maintain a market for the Shares trading on the 14 Where a Fund, as described above, permits an Stock Exchange. No Market Maker or Specialist will class of persons, securities or in-kind purchaser or redeemer to deposit or receive be an affiliated person, or an affiliated person of an cash in lieu of depositing one or more Deposit or affiliated person, of the Funds, except within 17 Applicants note that under accounting Redemption Instruments, the purchaser or redeemer section 2(a)(3)(A) or (C) of the Act due to ownership procedures followed by the Funds, trades made on may be assessed a higher Transaction Fee to offset of Shares, as described below. the prior Business Day will be booked and reflected the cost to the Fund of buying or selling those 16 Shares will be registered in book-entry form in NAV on the current Business Day. Accordingly, particular Deposit or Redemption Instruments. In only. DTC or its nominee will be the record or each Fund will be able to disclose at the beginning all cases, the Transaction Fee will be limited in registered owner of all outstanding Shares. of the Business Day the portfolio that will form the accordance with the requirements of the Beneficial ownership of Shares will be shown on basis for its NAV calculation at the end of such Commission applicable to open-end management the records of DTC or DTC Participants. Business Day.

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transactions, from any provisions of the Applicants state that secondary market cycle of the U.S. securities markets but Act, if and to the extent that such trading in Shares will take place at also on the delivery cycles present in exemption is necessary or appropriate negotiated prices, not at a current foreign markets in which those Funds in the public interest and consistent offering price described in the invest. Applicants have been advised with the protection of investors and the Prospectus, and not at a price based on that, under certain circumstances, the purposes fairly intended by the policy NAV. Thus, purchases and sales of delivery cycles for transferring Portfolio and provisions of the Act. Section 17(b) Shares in the secondary market will not Positions to redeeming investors, of the Act authorizes the Commission to comply with section 22(d) of the Act coupled with local market holiday exempt a proposed transaction from and rule 22c–1 under the Act. schedules, will require a delivery section 17(a) of the Act if evidence Applicants request an exemption under process of up to 12 calendar days. establishes that the terms of the section 6(c) from these provisions. Applicants therefore request relief from transaction, including the consideration 5. Applicants assert that the concerns section 22(e) in order to provide to be paid or received, are reasonable sought to be addressed by section 22(d) payment or satisfaction of redemptions and fair and do not involve of the Act and rule 22c–1 under the Act within the maximum number of overreaching on the part of any person with respect to pricing are equally calendar days required for such concerned, and the proposed satisfied by the proposed method of payment or satisfaction in the principal transaction is consistent with the pricing Shares. Applicants maintain that local markets where transactions in the policies of the registered investment while there is little legislative history Portfolio Positions of each Global Fund company and the general provisions of regarding section 22(d), its provisions, customarily clear and settle, but in all the Act. Section 12(d)(1)(J) of the Act as well as those of rule 22c–1, appear to cases no later than 12 calendar days provides that the Commission may have been designed to (a) prevent following the tender of a Creation exempt any person, security, or dilution caused by certain riskless- Unit.18 transaction, or any class or classes of trading schemes by principal 8. Applicants state that section 22(e) persons, securities or transactions, from underwriters and contract dealers, (b) was designed to prevent unreasonable, any provision of section 12(d)(1) if the prevent unjust discrimination or undisclosed and unforeseen delays in exemption is consistent with the public preferential treatment among buyers the actual payment of redemption interest and the protection of investors. resulting from sales at different prices, proceeds. Applicants assert that the and (c) assure an orderly distribution requested relief will not lead to the Sections 5(a)(1) and 2(a)(32) of the Act system of investment company shares problems that section 22(e) was 3. Section 5(a)(1) of the Act defines an by eliminating price competition from designed to prevent. Applicants state ‘‘open-end company’’ as a management brokers offering shares at less than the that allowing redemption payments for investment company that is offering for published sales price and repurchasing Creation Units of a Fund to be made sale or has outstanding any redeemable shares at more than the published within a maximum of 12 calendar days security of which it is the issuer. redemption price. would not be inconsistent with the Section 2(a)(32) of the Act defines a 6. Applicants believe that none of spirit and intent of section 22(e). redeemable security as any security, these purposes will be thwarted by Applicants state each Global Fund’s other than short-term paper, under the permitting Shares to trade in the statement of additional information terms of which the holder, upon its secondary market at negotiated prices. (‘‘SAI’’) will disclose those local presentation to the issuer, is entitled to Applicants state that (a) secondary holidays (over the period of at least one receive approximately a proportionate market trading in Shares does not year following the date of the SAI), if share of the issuer’s current net assets, involve the Funds as parties and cannot any, that are expected to prevent the or the cash equivalent. Because Shares result in dilution of an investment in delivery of redemption proceeds in will not be individually redeemable, Shares, and (b) to the extent different seven calendar days and the maximum applicants request an order that would prices exist during a given trading day, number of days needed to deliver the permit each Fund to redeem Shares in or from day to day, such variances occur proceeds for each affected Global Fund. Creation Units only. Applicants state as a result of third-party market forces, Applicants are not seeking relief from that investors may purchase Shares in such as supply and demand. Therefore, section 22(e) with respect to Global Creation Units from each Fund and applicants assert that secondary market Funds that do not effect redemptions in- redeem Creation Units from each Fund. transactions in Shares will not lead to kind. Applicants further state that because the discrimination or preferential treatment Section 12(d)(1) of the Act market price of Creation Units will be among purchasers. Finally, applicants disciplined by arbitrage opportunities, contend that the proposed distribution 9. Section 12(d)(1)(A) of the Act investors should be able to sell Shares system will be orderly because arbitrage prohibits a registered investment in the secondary market at prices that activity should ensure that the company from acquiring shares of an do not vary materially from their NAV. difference between the market price of investment company if the securities Shares and their NAV remains represent more than 3% of the total Section 22(d) of the Act and Rule 22c– immaterial. outstanding voting stock of the acquired 1 Under the Act company, more than 5% of the total 4. Section 22(d) of the Act, among Section 22(e) of the Act assets of the acquiring company, or, other things, prohibits a dealer from 7. Section 22(e) of the Act generally together with the securities of any other selling a redeemable security that is prohibits a registered investment investment companies, more than 10% currently being offered to the public by company from suspending the right of of the total assets of the acquiring or through a principal underwriter, redemption or postponing the date of company. Section 12(d)(1)(B) of the Act except at a current public offering price payment of redemption proceeds for described in the prospectus. Rule 22c– more than seven days after the tender of 18 Applicants acknowledge that no relief obtained 1 under the Act generally requires that a security for redemption. Applicants from the requirements of section 22(e) will affect any obligations that it may otherwise have under a dealer selling, redeeming, or observe that settlement of redemptions rule 15c6–1 under the Exchange Act. Rule 15c6–1 repurchasing a redeemable security do of Creation Units of Global Funds is requires that most securities transactions be settled so only at a price based on its NAV. contingent not only on the settlement within three business days of the trade date.

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prohibits a registered open-end 12. Applicants propose a condition to in section 12(d)(1)(A) of the Act, except investment company, its principal ensure that no Investing Fund or to the extent permitted by exemptive underwriter, or any other broker or Investing Fund Affiliate 19 (except to the relief from the Commission permitting dealer from selling its shares to another extent it is acting in its capacity as an the Fund to purchase shares of other investment company if the sale will investment adviser to a Fund) will cause investment companies for short-term cause the acquiring company to own a Fund to purchase a security in an cash management purposes. more than 3% of the acquired offering of securities during the 15. To ensure that an Investing Fund company’s voting stock, or if the sale existence of an underwriting or selling is aware of the terms and conditions of will cause more than 10% of the syndicate of which a principal the requested order, the Investing Funds acquired company’s voting stock to be underwriter is an Underwriting Affiliate must enter into an agreement with the owned by investment companies (‘‘Affiliated Underwriting’’). An respective Funds (‘‘FOF Participation generally. ‘‘Underwriting Affiliate’’ is a principal Agreement’’). The FOF Participation 10. Applicants request relief to permit underwriter in any underwriting or Agreement will include an Investing Funds to acquire Shares in selling syndicate that is an officer, acknowledgement from the Investing excess of the limits in section director, member of an advisory board, Fund that it may rely on the order only 12(d)(1)(A) of the Act and to permit the Investing Fund Advisor, Investing Fund to invest in a Fund and not in any other Funds, their principal underwriters and Sub-Advisor, employee or Sponsor of investment company. the Investing Fund, or a person of which any Broker to sell Shares to Investing Sections 17(a)(1) and (2) of the Act Funds in excess of the limits in section any such officer, director, member of an 12(d)(l)(B) of the Act. Applicants submit advisory board, Investing Fund Advisor, 16. Section 17(a) of the Act generally that the proposed conditions to the Investing Fund Sub-Advisor, employee prohibits an affiliated person of a requested relief address the concerns or Sponsor is an affiliated person registered investment company, or an underlying the limits in section 12(d)(1), (except any person whose relationship affiliated person of such a person which include concerns about undue to the Fund is covered by section 10(f) (‘‘second tier affiliate’’), from selling any influence, excessive layering of fees and of the Act is not an Underwriting security to or purchasing any security overly complex structures. Affiliate). from the company. Section 2(a)(3) of the 13. Applicants propose several 11. Applicants submit that their Act defines ‘‘affiliated person’’ to conditions to address the potential for proposed conditions address any include any person directly or indirectly layering of fees. Applicants note that the concerns regarding the potential for owning, controlling, or holding with board of directors or trustees of any power to vote, 5% or more of the undue influence. To limit the control Investing Management Company, that an Investing Fund may have over a outstanding voting securities of the including a majority of the directors or other person and any person directly or Fund, applicants propose a condition trustees who are not ‘‘interested prohibiting the adviser of an Investing indirectly controlling, controlled by, or persons’’ within the meaning of section under common control with, the other Management Company (‘‘Investing Fund 2(a)(19) of the Act (‘‘independent Advisor’’), sponsor of an Investing Trust person. Section 2(a)(9) of the Act directors or trustees’’), will be required defines ‘‘control’’ as the power to (‘‘Sponsor’’), any person controlling, to find that the advisory fees charged controlled by, or under common control exercise a controlling influence over the under the contract are based on services management or policies of a company with the Investing Fund Advisor or provided that will be in addition to, Sponsor, and any investment company and provides that a control relationship rather than duplicative of, services will be presumed where one person or issuer that would be an investment provided under the advisory contract of company but for sections 3(c)(1) or owns more than 25% of another any Fund in which the Investing person’s voting securities. Each Fund 3(c)(7) of the Act that is advised or Management Company may invest. sponsored by the Investing Fund may be deemed to be controlled by an Applicants also state that any sales Advisor and hence affiliated persons of Advisor, the Sponsor, or any person charges and/or service fees charged with controlling, controlled by, or under each other. In addition, the Funds may respect to shares of an Investing Fund be deemed to be under common control common control with the Investing will not exceed the limits applicable to Fund Advisor or Sponsor (‘‘Investing with any other registered investment a fund of funds as set forth in NASD company (or series thereof) advised by Fund’s Advisory Group’’) from Conduct Rule 2830.20 controlling (individually or in the an Advisor (an ‘‘Affiliated Fund’’). 14. Applicants submit that the 17. Applicants request an exemption aggregate) a Fund within the meaning of proposed arrangement will not create an under sections 6(c) and 17(b) of the Act section 2(a)(9) of the Act. The same overly complex fund structure. from sections 17(a)(1) and 17(a)(2) of the prohibition would apply to any sub- Applicants note that a Fund will be Act to permit in-kind purchases and adviser to an Investing Management prohibited from acquiring securities of redemptions of Creation Units by Company (‘‘Investing Fund Sub- any investment company or company persons that are affiliated persons or Advisor’’), any person controlling, relying on section 3(c)(1) or 3(c)(7) of second tier affiliates of the Funds solely controlled by or under common control the Act in excess of the limits contained by virtue of one or more of the with the Investing Fund Sub-Advisor, following: (a) Holding 5% or more, or in and any investment company or issuer 19 An ‘‘Investing Fund Affiliate’’ is any Investing excess of 25% of the outstanding Shares that would be an investment company Fund Advisor, Investing Fund Sub-Advisor, of one or more Funds; (b) having an but for sections 3(c)(1) or 3(c)(7) of the Sponsor, promoter and principal underwriter of an affiliation with a person with an Act (or portion of such investment Investing Fund, and any person controlling, controlled by or under common control with any ownership interest described in (a); or company or issuer) advised or of these entities. ‘‘Fund Affiliate’’ is an investment (c) holding 5% or more, or more than sponsored by the Investing Fund Sub- adviser, promoter, or principal underwriter of a 25% of the Shares of one or more Advisor or any person controlling, Fund or any person controlling, controlled by or Affiliated Funds.21 Applicants also controlled by or under common control under common control with any of these entities. 20 Any reference to NASD Conduct Rule 2830 with the Investing Fund Sub-Advisor includes any successor or replacement rule that 21 Applicants are not seeking relief from section (‘‘Investing Fund’s Sub-Advisory may be adopted by the Financial Industry 17(a) for, and the requested relief will not apply to, Group’’). Regulatory Authority. Continued

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request an exemption in order to permit redemption of Shares directly from a date of any Commission rule under the a Fund to sell its Shares to and redeem Fund will be based on the NAV of the Act that provides relief permitting the its Shares from, and engage in the in- Fund in accordance with policies and operation of actively-managed kind transactions that would procedures set forth in the Fund’s exchange-traded funds. accompany such sales and redemptions registration statement.23 Applicants also B. 12(d)(1) Relief with, certain Investing Funds of which state that the proposed transactions are the Funds are affiliated persons or consistent with the general purposes of 1. The members of the Investing second-tier affiliates.22 the Act and appropriate in the public Fund’s Advisory Group will not control 18. Applicants assert that no useful interest. (individually or in the aggregate) a Fund purpose would be served by prohibiting within the meaning of section 2(a)(9) of such affiliated persons from making in- Applicants’ Conditions the Act. The members of the Investing kind purchases or in-kind redemptions Applicants agree that any order of the Fund’s Sub-Advisory Group will not of Shares of a Fund in Creation Units. Commission granting the requested control (individually or in the aggregate) The Deposit Instruments and relief will be subject to the following a Fund within the meaning of section Redemption Instruments available for a conditions: 2(a)(9) of the Act. If, as a result of a decrease in the outstanding voting Fund will be the same for all purchasers A. ETF Relief and redeemers, respectively, and will securities of a Fund, the Investing correspond pro rata to the Fund’s 1. As long as a Fund operates in Fund’s Advisory Group or the Investing Portfolio Positions, except as described reliance on the requested order, the Fund’s Sub-Advisory Group, each in the above. The deposit procedures for in- Shares of the Fund will be listed on a aggregate, becomes a holder of more kind purchases of Creation Units and Stock Exchange. than 25 percent of the outstanding the redemption procedures for in-kind 2. Neither the Trust nor any Fund will voting securities of a Fund, it will vote redemptions will be the same for all be advertised or marketed as an open- its Shares in the same proportion as the purchases and redemptions. Deposit end investment company or a mutual vote of all other holders of the Shares. Instruments and Redemption fund. Any advertising material that This condition does not apply to the Instruments will be valued in the same describes the purchase or sale of Investing Fund’s Sub-Advisory Group manner as those Portfolio Positions Creation Units or refers to redeemability with respect to a Fund for which the currently held by the relevant Funds, will prominently disclose that the Investing Fund Sub-Advisor or a person and the valuation of the Deposit Shares are not individually redeemable controlling, controlled by or under Instruments and Redemption and that owners of the Shares may common control with the Investing Instruments will be made in the same acquire those Shares from the Fund and Fund Sub-Advisor acts as the manner, regardless of the identity of the tender those Shares for redemption to investment adviser within the meaning purchaser or redeemer. Applicants do the Fund in Creation Units only. of section 2(a)(20)(A) of the Act. not believe that in-kind purchases and 3. The Web site for the Funds, which 2. No Investing Fund or Investing redemptions will result in abusive self- is and will be publicly accessible at no Fund Affiliate will cause any existing or dealing or overreaching of the Fund. charge, will contain, on a per Share potential investment by the Investing 19. Applicants also submit that the basis, for each Fund the prior Business Fund in a Fund to influence the terms sale of Shares to and redemption of Day’s NAV and the market closing price of any services or transactions between Shares from an Investing Fund meets or Bid/Ask Price, and a calculation of the Investing Fund or an Investing Fund the standards for relief under sections the premium or discount of the market Affiliate and the Fund or a Fund 17(b) and 6(c) of the Act. The FOF closing price or Bid/Ask Price against Affiliate. Participation Agreement will require such NAV. 3. The board of directors or trustees of any Investing Fund that purchases 4. On each Business Day, before an Investing Management Company, Creation Units directly from a Fund to commencement of trading in Shares on including a majority of the independent represent that the purchase of Creation the Stock Exchange, the Fund will directors or trustees, will adopt Units from a Fund by an Investing Fund disclose on its Web site the identities procedures reasonably designed to will be accomplished in compliance and quantities of the Portfolio Positions ensure that the Investing Fund Advisor with the investment restrictions of the held by the Fund that will form the and any Investing Fund Sub-Advisor are Investing Fund and will be consistent basis for the Fund’s calculation of NAV conducting the investment program of with the investment policies set forth in at the end of the Business Day. the Investing Management Company the Investing Fund’s registration 5. The Advisor or any Subadvisor, without taking into account any statement. Applicants note that any directly or indirectly, will not cause any consideration received by the Investing consideration paid for the purchase or Authorized Participant (or any investor Management Company or an Investing on whose behalf an Authorized Fund Affiliate from a Fund or a Fund transactions where a Fund could be deemed an Participant may transact with the Fund) Affiliate in connection with any services affiliated person, or an affiliated person of an to acquire any Deposit Instrument for or transactions. affiliated person, of an Investing Fund because an the Fund through a transaction in which 4. Once an investment by an Investing investment adviser to the Funds is also an the Fund could not engage directly. Fund in Shares exceeds the limit in investment adviser to an Investing Fund. 6. The requested relief to permit ETF 22 Applicants expect most Investing Funds will section 12(d)(1)(A)(i) of the Act, the purchase Shares in the secondary market and will operations will expire on the effective Board of the Fund, including a majority not purchase Creation Units directly from a Fund. of the independent directors or trustees, To the extent that purchases and sales of Shares 23 Applicants acknowledge that the receipt of will determine that any consideration occur in the secondary market and not through compensation by (a) an affiliated person of an principal transactions directly between an Investing Investing Fund, or an affiliated person of such paid by the Fund to the Investing Fund Fund and a Fund, relief from section 17(a) would person, for the purchase by the Investing Fund of or an Investing Fund Affiliate in not be necessary. However, the requested relief Shares of the Fund or (b) an affiliated person of a connection with any services or would apply to direct sales of Shares in Creation Fund, or an affiliated person of such person, for the transactions: (i) Is fair and reasonable in Units by a Fund to an Investing Fund and sale by the Fund of its Shares to an Investing Fund, redemptions of those Shares. The requested relief may be prohibited by section 17(e)(1) of the Act. relation to the nature and quality of the is intended to also cover the in-kind transactions The FOF Participation Agreement also will include services and benefits received by the that may accompany such sales and redemptions. this acknowledgment. Fund; (ii) is within the range of

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consideration that the Fund would be purchases were influenced by the Fund will notify the Fund of any required to pay to another unaffiliated investment by the Investing Fund in the changes to the list as soon as reasonably entity in connection with the same Fund. The Board will consider, among practicable after a change occurs. The services or transactions; and (iii) does other things: (i) Whether the purchases Fund and the Investing Fund will not involve overreaching on the part of were consistent with the investment maintain and preserve a copy of the any person concerned. This condition objectives and policies of the Fund; (ii) order, the FOF Participation Agreement, does not apply with respect to any how the performance of securities and the list with any updated services or transactions between a Fund purchased in an Affiliated Underwriting information for the duration of the and its investment adviser(s), or any compares to the performance of investment and for a period of not less person controlling, controlled by or comparable securities purchased during than six years thereafter, the first two under common control with such a comparable period of time in years in an easily accessible place. investment adviser(s). underwritings other than Affiliated 5. The Investing Fund Advisor, or Underwritings or to a benchmark such 10. Before approving any advisory Trustee or Sponsor, as applicable, will as a comparable market index; and (iii) contract under section 15 of the Act, the waive fees otherwise payable to it by the whether the amount of securities board of directors or trustees of each Investing Fund in an amount at least purchased by the Fund in Affiliated Investing Management Company, equal to any compensation (including Underwritings and the amount including a majority of the independent fees received pursuant to any plan purchased directly from an directors or trustees, will find that the adopted by a Fund under rule 12b–1 Underwriting Affiliate have changed advisory fees charged under such under the Act) received from a Fund by significantly from prior years. The contract are based on services provided the Investing Fund Advisor, or Trustee Board will take any appropriate actions that will be in addition to, rather than or Sponsor, or an affiliated person of the based on its review, including, if duplicative of, the services provided Investing Fund Advisor, or Trustee or appropriate, the institution of under the advisory contract(s) of any Sponsor, other than any advisory fees procedures designed to ensure that Fund in which the Investing paid to the Investing Fund Advisor, or purchases of securities in Affiliated Management Company may invest. Trustee, or Sponsor, or its affiliated Underwritings are in the best interest of These findings and their basis will be person by the Fund, in connection with shareholders. the investment by the Investing Fund in 8. Each Fund will maintain and recorded fully in the minute books of the Fund. Any Investing Fund Sub- preserve permanently in an easily the appropriate Investing Management Advisor will waive fees otherwise accessible place a written copy of the Company. payable to the Investing Fund Sub- procedures described in the preceding 11. Any sales charges and/or service Advisor, directly or indirectly, by the condition, and any modifications to fees charged with respect to shares of an Investing Management Company in an such procedures, and will maintain and Investing Fund will not exceed the amount at least equal to any preserve for a period of not less than six limits applicable to a fund of funds as compensation received from a Fund by years from the end of the fiscal year in set forth in NASD Conduct Rule 2830. the Investing Fund Sub-Advisor, or an which any purchase in an Affiliated affiliated person of the Investing Fund Underwriting occurred, the first two 12. No Fund relying on the section Sub-Advisor, other than any advisory years in an easily accessible place, a 12(d)(1) relief will acquire securities of fees paid to the Investing Fund Sub- written record of each purchase of any investment company or company Advisor or its affiliated person by the securities in Affiliated Underwritings relying on section 3(c)(1) or 3(c)(7) of Fund, in connection with the once an investment by an Investing the Act in excess of the limits contained investment by the Investing Fund in the securities of the Fund in section 12(d)(1)(A) of the Act, except Management Company in the Fund exceeds the limit of section to the extent permitted by exemptive made at the direction of the Investing 12(d)(1)(A)(i) of the Act, setting forth relief from the Commission permitting Fund Sub-Advisor. In the event that the from whom the securities were the Fund to purchase shares of other Investing Fund Sub-Advisor waives acquired, the identity of the investment companies for short-term fees, the benefit of the waiver will be underwriting syndicate’s members, the cash management purposes. passed through to the Investing terms of the purchase, and the For the Commission, by the Division of Management Company. information or materials upon which Investment Management, under delegated 6. No Investing Fund or Investing the Board’s determinations were made. Fund Affiliate (except to the extent it is 9. Before investing in Shares in excess authority. acting in its capacity as an investment of the limits in section 12(d)(1)(A), each Kevin M. O’Neill, adviser to a Fund) will cause a Fund to Investing Fund and the Fund will Deputy Secretary. purchase a security in an Affiliated execute an FOF Participation Agreement [FR Doc. 2013–19039 Filed 8–6–13; 8:45 am] Underwriting. stating, without limitation, that their BILLING CODE 8011–01–P 7. The Board of a Fund, including a boards of directors or trustees and their majority of the independent directors or investment advisers, or Trustee and trustees, will adopt procedures Sponsor, as applicable, understand the reasonably designed to monitor any terms and conditions of the order, and purchases of securities by the Fund in agree to fulfill their responsibilities an Affiliated Underwriting, once an under the order. At the time of its investment by an Investing Fund in the investment in Shares in excess of the securities of the Fund exceeds the limit limit in section 12(d)(1)(A)(i), an of section 12(d)(1)(A)(i) of the Act, Investing Fund will notify the Fund of including any purchases made directly the investment. At such time, the from an Underwriting Affiliate. The Investing Fund will also transmit to the Board will review these purchases Fund a list of the names of each periodically, but no less frequently than Investing Fund Affiliate and annually, to determine whether the Underwriting Affiliate. The Investing

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SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s OCC rule change and having expiration COMMISSION Statement of the Purpose of, and dates later than February 1, 2015. Statutory Basis for, the Proposed Rule Option contracts having non-standard [Release No. 34–70091; File No. SR–CBOE– Change expiration dates (‘‘non-standard 2013–073] expiration contracts’’) will be unaffected 1. Purpose by this proposed rule change, except Self-Regulatory Organizations; The Exchange is proposing to change that FLEX options having expiration Chicago Board Options Exchange, the expiration date for most option dates later than February 1, 2015 cannot Incorporated; Notice of Filing and contracts to the third Friday of the expire on a Saturday unless they are Immediate Effectiveness of a Proposed expiration month instead of the specified by OCC as grandfathered.6 Rule Change To Change the Expiration Saturday following the third Friday. In order to provide a smooth Date For Most Option Contracts to the More specifically, the Exchange is transition to the Friday expiration OCC Third Friday of the Expiration Month proposing to amend rule text has begun to move the expiration Instead of the Saturday Following the referencing Saturday expirations. The exercise procedures to Friday for all Third Friday Exchange notes, however, that this standard expiration contracts even though the contracts would continue to August 1, 2013. change will apply to all standard expiration contracts including those in expire on Saturday.7 After February 1, Pursuant to Section 19(b)(1) of the which the rules are silent on the 2015, virtually all standard expiration Securities Exchange Act of 1934 (the expiration date. The Exchange is making contracts will actually expire on Friday. ‘‘Act’’) 1 and Rule 19b–4 thereunder,2 this filing to harmonize its rules in The only standard expiration contracts notice is hereby given that on July 19, connection with a recently approved that will expire on a Saturday after 2013, the Chicago Board Options rule filing made by The Options February 1, 2015 are certain options that Exchange, Incorporated (‘‘Exchange’’ or Clearing Corporation (‘‘OCC’’) which were listed prior to the effectiveness of ‘‘CBOE’’) filed with the Securities and made substantially similar changes.3 the OCC rule change, and a limited Exchange Commission (‘‘Commission’’) The Exchange believes that the industry number of options that may be listed the proposed rule change as described must remain consistent in expiration prior to necessary systems changes of in Items I, II, and III below, which Items dates, and, thus, is proposing to update the options exchanges, which are have been prepared by the self- its rules to remain consistent with those expected to be completed in August regulatory organization. The of OCC. In addition, the Exchange 2013. After these systems changes are Commission is publishing this notice to understands that other exchanges will made, CBOE will not list any additional solicit comments on the proposed rule be filing similar rules to effect this options with Saturday expiration dates change from interested persons. industry-wide initiative. falling after February 1, 2015. CBOE I. Self-Regulatory Organization’s Most option contracts (‘‘standard understands that the other exchanges Statement of the Terms of Substance of expiration contracts’’) currently expire are committed to the same listing the Proposed Rule Change at the ‘‘expiration time’’ (11:59 p.m. schedule. The Exchange notes that OCC, The Exchange proposes to amend Eastern Time) on the Saturday following the third Friday of the specified industry groups, clearing members and Exchange rules to change the expiration the other exchanges have been active date for most option contracts to the expiration month (the ‘‘expiration 4 participants in planning for the third Friday of the expiration month date’’). With this filing, the Exchange is proposing to give advance notice to its transition to the Friday expiration.8 In instead of the Saturday following the March, 2012, OCC began to discuss third Friday. The text of the proposed Trading Permit Holders (‘‘TPHs’’) that the expiration date for standard moving standard contract expirations to rule change is available on the Friday expiration dates with industry Exchange’s Web site (http:// expiration contracts is changing to the 5 groups, including two Securities www.cboe.com/AboutCBOE/ third Friday of the expiration month. (The expiration time would continue to Industry and Financial Markets CBOELegalRegulatoryHome.aspx), at Association (‘‘SIFMA’’) committees, the the Exchange’s Office of the Secretary, be 11:59 p.m. Eastern Time on the expiration date.) The change would Operations and Technology Steering and at the Commission’s Public Committee and the Options Committee, Reference Room. apply only to standard expiration contracts expiring after February 1, and at two major industry conferences, II. Self-Regulatory Organization’s 2015, and the Exchange, similar to OCC, the SIFMA Operations Conference and Statement of the Purpose of, and does not propose to change the the Options Industry Conference.9 OCC Statutory Basis for, the Proposed Rule expiration date for any outstanding also discussed the project with the Change option contracts. The change will apply Intermarket Surveillance Group and at an OCC Operations Roundtable. In each In its filing with the Commission, the only to series of option contracts opened case, there was broad support for the Exchange included statements for trading after the effective date of the initiative.10 concerning the purpose of and basis for 3 Certain option contracts have already the proposed rule change and discussed See Securities Exchange Act Release No. 34– 69772 (June 17, 2013), 78 FR 37645 (June 21, 2013) been listed with Saturday expiration any comments it received on the (order approving SR–OCC–2013–004). dates as distant as December 2016 proposed rule change. The text of these 4 Examples of options with non-standard (which is the furthest out expiration as statements may be examined at the expiration contracts include: Volatility Index of the date of this filing). Additionally, places specified in Item IV below. The options (Rule 24.9(a)(5)), FLEX options (Rules 24A.4(a)(2)(iv) and 24B.4(a)(iv)), Quarterly Index until CBOE completes certain systems Exchange has prepared summaries, set expirations (Rule 24.9(c)), End of Week and End of enhancements in August 2013, it forth in sections A, B, and C below, of Month expirations (Rule 24.9(e)), Quarterly Option Series (Rules 5.5(e) and 24.9(a)(2)(B)) and Short the most significant aspects of such 6 Term Option Series (Rules 5.5(d) and 24.9(a)(2)(A)). See note 4 supra. statements. 7 5 The Exchange has already given notice to TPHs See SR–OCC–2013–04. regarding the anticipated change. See Exchange 8 Id. 1 15 U.S.C.78s(b)(1). Regulatory Circular RG12–135 released on October 9 Id. 2 17 CFR 240.19b–4. 5, 2012. 10 Id.

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remains possible that additional option Exchange believes the proposed change changes do not permit unfair contracts may be listed with Saturday will keep the Exchange consistent with discrimination between any TPHs expiration dates beyond February 1, the processing at OCC and will enable because they are applied to all TPHs 2015. For these contracts, transitioning the Exchange to give effect to the equally. In the alternative, the Exchange to a Friday expiration for newly listed industry-wide initiative. In addition, the believes that it helps all TPHs by option contracts expiring after February Exchange understands that other keeping the Exchange consistent with 1, 2015 would create a situation under exchanges will be filing similar rules, OCC practices and those of other which certain options with open thus creating a uniform expiration date Exchanges. interest would expire on a Saturday for standard options on listed classes. B. Self-Regulatory Organization’s while other options with open interest The Exchange plans to release another Statement on Burden on Competition would expire on a Friday in the same circular to TPHs to put TPHs on notice expiration month. of this change prior to the CBOE does not believe that the Clearing members have expressed a implementation of the rule. proposed rule change will impose any burden on competition that is not clear preference to not have a mix of 2. Statutory Basis options with open interest that expire necessary or appropriate in furtherance on different days in a single month.11 The Exchange believes the proposed of the purposes of the Act. Specifically, Accordingly, OCC represented in its rule change is consistent with the the Exchange does not believe the recently approved filing that it will not Securities Exchange Act of 1934 (the proposed rule change will impose a issue and clear any new option contract ‘‘Act’’) and the rules and regulations burden on intramarket competition with a Friday expiration if existing thereunder applicable to the Exchange because it will be applied to all TPHs option contracts of the same options and, in particular, the requirements of equally. In addition, the Exchange does 14 class expire on the Saturday following Section 6(b) of the Act. Specifically, not believe the proposed rule change the third Friday of the same month. the Exchange believes the proposed rule will impose any burden to intermarket However, Friday expiration processing change is consistent with the Section competition because it will be applied 15 will be in effect for these Saturday 6(b)(5) requirements that the rules of industry wide and apply to all market expiration contracts. As with standard an exchange be designed to prevent participants. The proposed rule change expiration options during the transition fraudulent and manipulative acts and is structured to enhance competition period, exercise requests received after practices, to promote just and equitable because the shift from an expiration Friday expiration processing is principles of trade, to foster cooperation date of the Saturday following the third complete but before the Saturday and coordination with persons engaged Friday to the third Friday is anticipated contract expiration time will continue to in regulating, clearing, settling, to be adopted industry-wide and will be processed without fines or penalties. processing information with respect to, apply to all multiply listed classes. This Thus, the Exchange is proposing to and facilitating transactions in in turn will allow CBOE to compete update its rules to reflect the above securities, to remove impediments to more effectively with other exchanges discussed change. More specifically, the and perfect the mechanism of a free and making similar rule changes. Exchange is proposing to add Rule open market and a national market system, and, in general, to protect C. Self-Regulatory Organization’s 1.1(mmm) to define ‘‘Expiration Date’’ Statement on Comments on the to be consistent with the revised OCC investors and the public interest. 12 Additionally, the Exchange believes the Proposed Rule Change Received From definition. The Exchange is also Members, Participants, or Others proposing to update Exchange Rules proposed rule change is consistent with 16 23.5 and 24.9 which reference Saturday the Section 6(b)(5) requirement that The Exchange neither solicited nor expiration dates (which are the only two the rules of an exchange not be designed received comments on the proposed Exchange rules that identify Saturday as to permit unfair discrimination between rule change. The Exchange notes, the expiration date). Thus, consistent customers, issuers, brokers, or dealers. however, that a favorable comment was with the OCC filing, the Exchange is In particular, the Exchange believes submitted to the OCC filing. that keeping its rules consistent with proposing to add language to these rules III. Date of Effectiveness of the stating that any series expiring prior to those of the industry will protect all participants in the market by Proposed Rule Change and Timing for February 1, 2015 will have a Saturday Commission Action expiration date while any series eliminating confusion. The proposed expiring on or after February 1, 2015 changes thus allow for a more orderly Because the foregoing proposed rule will have a Friday expiration date.13 market by allowing all options markets, change does not: (i) Significantly affect The Exchange is also proposing, with including the clearing agencies, to have the protection of investors or the public this filing, to replace any reference in the same expiration date for standard interest; (ii) impose any significant the purpose section of any past options. In addition, the proposed burden on competition; and (iii) become Exchange rule filings or previously changes will foster cooperation and operative for 30 days from the date on released circulars to any expiration date coordination with persons engaged in which it was filed, or such shorter time other than Friday for a standard options regulating clearing, settling, processing as the Commission may designate, it has contract with the new Friday standard. information with respect to, and become effective pursuant to Section facilitating transactions in securities by 19(b)(3)(A) of the Act 17 and Rule 19b– Essentially, the Exchange is now 18 proposing to replace any historic aligning a pivotal part of the options 4(f)(6) thereunder. At any time within 60 days of the references to expiration dates to be processing to be consistent industry filing of the proposed rule change, the replaced with the proposed Friday wide. If the industry were to differ, Commission summarily may expiration. As stated above, the investors would suffer from confusion and be more vulnerable to violate temporarily suspend such rule change if it appears to the Commission that such 11 Id. different exchange rules. The proposed 12 Id. action is necessary or appropriate in the 13 With the exception of expirations that were 14 15 U.S.C. 78f(b). listed prior to the effective date of the OCC filing 15 15 U.S.C. 78f(b)(5). 17 15 U.S.C. 78s(b)(3)(A). and have open interest. 16 Id. 18 17 CFR 240.19b–4(f)(6).

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public interest, for the protection of should refer to File Number SR–CBOE– (‘‘GLN 10 oz. Gold Futures’’) 5 proposed investors, or otherwise in furtherance of 2013–073 and should be submitted on to be traded by NASDAQ OMX Futures the purposes of the Act. If the or before August 28, 2013. Exchange, Inc. (‘‘NFX’’); and (ii) remove Commission takes such action, the For the Commission, by the Division of provisions applicable only to the now- Commission will institute proceedings Trading and Markets, pursuant to delegated discontinued U.S. dollar-settled gold to determine whether the proposed rule authority.19 futures that were based on the value of change should be approved or Kevin M. O’Neill, gold in the spot market with an disapproved. Deputy Secretary. additional daily cost of carry feature that was designed to reflect the IV. Solicitation of Comments [FR Doc. 2013–19037 Filed 8–6–13; 8:45 am] difference between the overnight lease BILLING CODE 8011–01–P Interested persons are invited to rate for gold and the overnight interest submit written data, views, and rate for the U.S. dollar, which were also arguments concerning the foregoing, SECURITIES AND EXCHANGE traded by NFX (‘‘Swap Point Gold including whether the proposed rule COMMISSION Futures’’). change is consistent with the Act. Comments may be submitted by any of [Release No. 34–70092; File No. SR–OCC– II. Clearing Agency’s Statement of the the following methods: 2013–11] Purpose of, and Statutory Basis for, the Proposed Rule Change Electronic Comments Self-Regulatory Organizations; The In its filing with the Commission, • Use the Commission’s Internet Options Clearing Corporation; Notice OCC included statements concerning comment form (http://www.sec.gov/ of Filing and Immediate Effectiveness the purpose of and basis for the rules/sro.shtml ); or of Proposed Rule Change To: (i) proposed rule change and discussed any • Send an email to rule- Provide Clarification Regarding the comments it received on the proposed [email protected]. Please include File Applicability of Certain Provisions of rule change. The text of these statements Number SR–CBOE–2013–073 on the OCC’s By-Laws and Rules to Certain may be examined at the places specified subject line. U.S. Dollar-Settled Gold Futures in Item IV below. OCC has prepared Designed to Replicate Positions in the Paper Comments summaries, set forth in sections (A), (B), Spot Market; and (ii) Remove and (C) below, of the most significant • Send paper comments in triplicate Provisions Applicable Only to the Now- aspects of these statements. to Elizabeth M. Murphy, Secretary, Discontinued U.S. Dollar-Settled Gold Securities and Exchange Commission, Futures That Were Based on the Value (A) Clearing Agency’s Statement of the 100 F Street NE., Washington, DC of Gold in the Spot Market With an Purpose of, and Statutory Basis for, the 20549–1090. Additional Daily Cost of Carry Feature Proposed Rule Change All submissions should refer to File OCC is proposing to modify its rules Number SR–CBOE–2013–073. This file August 1, 2013. Pursuant to Section 19(b)(1) of the to provide clarification regarding the number should be included on the applicability of certain provisions of subject line if email is used. To help the Securities Exchange Act of 1934 1 2 OCC’s By-Laws and Rules to the Commission process and review your (‘‘Act’’) and Rule 19b–4 thereunder, notice is hereby given that, on July 25, clearance and settlement of GLN 10 oz. comments more efficiently, please use Gold Futures, which are proposed to be only one method. The Commission will 2013, The Options Clearing Corporation (‘‘OCC’’) filed with the Securities and traded by NFX. A GLN 10 oz. Gold post all comments on the Commission’s Future is a U.S. dollar-settled futures Internet Web site (http://www.sec.gov/ Exchange Commission (‘‘Commission’’) the proposed rule change described in contract that tracks spot gold prices rules/sro.shtml ). Copies of the using a single contract month for a submission, all subsequent Items I, II and III below, which Items have been prepared primarily by OCC. particular year. OCC’s existing By-Laws amendments, all written statements and Rules already adequately with respect to the proposed rule OCC filed the proposed rule change 3 accommodate OCC’s clearing and change that are filed with the pursuant to Section 19(b)(3)(A)(iii) of the Act and Rule 19b–4(f)(4)(ii) 4 settlement of GLN 10 oz. Gold Futures. Commission, and all written However, OCC is proposing certain communications relating to the thereunder, so that the proposal was effective upon filing with the amendments in order to eliminate any proposed rule change between the potential confusion regarding the Commission and any person, other than Commission. The Commission is publishing this notice to solicit applicability of certain provisions that those that may be withheld from the were specific to the now-discontinued public in accordance with the comments on the rule change from interested parties. Swap Point Gold Futures contracts. GLN provisions of 5 U.S.C. 552, will be 10 oz. Gold Futures differ from Swap available for Web site viewing and I. Clearing Agency’s Statement of the Point Gold Futures, which previously printing in the Commission’s Public Terms of Substance of the Proposed were but are no longer cleared by OCC, Reference Room, 100 F Street NE., Rule Change in that they do not include a Cost of Washington, DC 20549, on official OCC proposes to do the following: (i) Carry Payment (defined below). Swap business days between the hours of Provide clarification regarding the Point Gold Futures were U.S. dollar- 10:00 a.m. and 3:00 p.m. Copies of such applicability of certain provisions of settled futures contracts based on the filing also will be available for OCC’s By-Laws and Rules to certain value of gold with an additional daily inspection and copying at the principal U.S. dollar-settled gold futures designed cost of carry/interest payment feature office of the Exchange. All comments to replicate positions in the spot market that was designed to reflect the received will be posted without change; difference between the overnight lease the Commission does not edit personal 19 17 CFR 200.30–3(a)(12). rate for gold and the overnight interest identifying information from 1 15 U.S.C. 78s(b)(1). rate for the U.S. dollar (the ‘‘Cost of submissions. You should submit only 2 17 CFR 240.19b–4. information that you wish to make 3 15 U.S.C. 78s(b)(3)(A)(iii). 5 ‘‘GLN’’ will be the ticker symbol for these publicly available. All submissions 4 17 CFR 240.19b–4(f)(4)(ii). futures contracts.

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Carry Payment’’). NFX has advised OCC specific types of contracts enumerated (C) Clearing Agency’s Statement on that it has no present intention to clear in the Agreement and may agree to clear Comments on the Proposed Rule swap point contracts in the future. additional types through the execution Change Received From Members, (i) OCC’s Proposed By-Laws and Rules by both parties of a new ‘‘Schedule C’’ Participants or Others Changes to the Agreement. A copy of the proposed new Schedule C providing for Written comments on the proposed OCC proposes to delete paragraph (f) the clearance of GLN 10 oz. Gold rule change were not and are not of Rule 1301, which provided for OCC’s Futures is attached hereto as Exhibit 3B. intended to be solicited with respect to determination of the Cost of Carry the proposed rule change and none have Payment to be paid or received by (iii) Effect on Clearing Members been received. buyers and sellers of outstanding spot futures contracts. GLN 10 oz. Gold The proposed rule change relates to III. Date of Effectiveness of the Futures do not possess this Cost of Carry the clearing of a new product and will Proposed Rule Change and Timing for Payment feature, and therefore Rule affect clearing members and their Commission Action 1301(f) is not applicable to them. Swap customers to the extent that they seek to Point Gold Futures—the only product trade GLN 10 oz. Gold Futures. The This proposed rule change is filed for previously cleared by OCC that change will affect all such clearing immediate effectiveness pursuant to possessed the Cost of Carry Payment members equally and should not impose Section 19(b)(3)(A)(iii) of the Act 7 and feature—are no longer cleared by OCC, any compliance burdens on clearing Rule 19b–4(f)(4)(ii) 8 thereunder. and Rule 1301(f) therefore is no longer members, because GLN 10 oz. Gold Pursuant to Rule 19b–4(f)(4)(ii),9 a rule needed, and OCC proposes to delete the Futures will be cleared using existing change may take effect upon filing if it provision from its Rules. Accordingly, systems and will be margined similarly primarily affects the clearing operations the defined terms ‘‘cost of carry to other existing products. of the clearing agency with respect to payment’’ and ‘‘spot future,’’ which The proposed changes to OCC’s By- products that are not securities and does were only utilized in the context of the Laws and Rules are consistent with the not significantly affect any securities cost of carry payment, are both purposes and requirements of Section clearing operations of the clearing superfluous, and OCC proposes to 17A(b)(3)(A) of the Securities Exchange agency or any rights or obligations of the delete them from Article I of the By- clearing agency with respect to Laws. OCC also proposes to delete a Act of 1934, as amended (the ‘‘Exchange Act’’ or ‘‘Act’’) 6, because they are securities clearing or persons using such reference in Section 2(a) of Article XII securities-clearing service. As described of OCC’s By-Laws to the applicability of designed to permit OCC to perform above, this proposed rule change the cost of carry payment provisions of clearing services for products that are concerns futures products that are Rule 1301 to buyers and sellers of spot subject to the jurisdiction of the futures. Commodity Futures Trading subject to the primary jurisdiction of the Commission (the ‘‘CFTC’’) without CFTC and does not adversely affect (ii) OCC’s Amendment to the Clearing adversely affecting OCC’s obligations OCC’s obligations with respect to the Agreement and Schedule C with respect to the prompt and accurate prompt and accurate clearance and OCC performs the clearing function clearance and settlement of securities settlement of securities transactions or for NFX pursuant to the Clearing transactions or the protection of the protection of securities investors Agreement. The Clearing Agreement securities investors and the public and the public interest. Notwithstanding provides that NFX will provide interest. They accomplish this purpose the foregoing, OCC will delay its settlement prices to OCC and indemnify by providing clarification regarding the implementation of this rule change until OCC in the event that OCC uses an applicability of certain provisions of it is deemed certified under Regulation incorrect settlement price provided by OCC’s By-Laws and Rules to GLN 10 oz. § 40.6 10 of the CFTC. NFX. Additionally, it provides that NFX Gold Futures, and remove provisions of At any time within 60 days of the will provide certain additional data OCC’s By-Laws and Rules that are only filing of this proposed rule change, the necessary for the calculating of the Cost applicable to Swap Point Gold Futures, of Carry Payment (‘‘Swap Point Data’’) Commission summarily may a discontinued product. The proposed temporarily suspend this rule change if and indemnify OCC in the event OCC rule change is not inconsistent with any uses incorrect Swap Point Data it appears to the Commission that such rules of OCC, including any rules action is necessary or appropriate in the provided by NFX. As OCC will no proposed to be amended. longer be clearing Swap Point Gold public interest, for the protection of Futures, there is no need for the (B) Clearing Agency’s Statement on investors, or otherwise in furtherance of Clearing Agreement to address NFX’s Burden on Competition the purposes of the Act.11 providing Swap Point Data, or for NFX IV. Solicitation of Comments to indemnify OCC for its use of such OCC does not believe that the Swap Point Data. Therefore, OCC proposed rule change would impose any Interested persons are invited to proposes to enter into an amendment to burden on competition that is not submit written data, views, and the Clearing Agreement deleting these necessary or appropriate in furtherance arguments concerning the foregoing, of the Act because it relates solely to a provisions. The Clearing Agreement will including whether the proposed rule commodity futures product subject to continue to provide for NFX’s change is consistent with the Act. the exclusive jurisdiction of the indemnification of OCC in the event Comments may be submitted by any of Commodity Futures Trading that OCC uses an incorrect settlement the following methods: price provided by NFX. A copy of the Commission and therefore will not have any impact, or impose any burden, on proposed amendment to the Clearing 7 competition in securities markets or any 15 U.S.C. 78s(b)(3)(A)(iii). Agreement is attached hereto as Exhibit 8 17 CFR 240.19b–4(f)(4)(ii). 3A. other market governed by the Act. 9 Id. Pursuant to the terms of the Clearing 10 17 CFR Part 40. Agreement, OCC has agreed to clear the 6 15 U.S.C. 78q–1. 11 15 U.S.C. 78s(b)(3)(C).

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Electronic Comments DEPARTMENT OF STATE the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. • Use the Commission’s Internet [Public Notice 8412] comment form (http://www.sec.gov/ 2459), Executive Order 12047 of March rules/sro.shtml); or Culturally Significant Objects Imported 27, 1978, the Foreign Affairs Reform and • Send an email to rule- for Exhibition Determinations: Restructuring Act of 1998 (112 Stat. [email protected]. Please include File ‘‘Heaven and Earth: Art of Byzantium 2681, et seq.; 22 U.S.C. 6501 note, et Number SR–OCC-2013–11 on the from Greek Collections’’ seq.), Delegation of Authority No. 234 of subject line. October 1, 1999, and Delegation of SUMMARY: Notice is hereby given of the Authority No. 236–3 of August 28, 2000, Paper Comments following determinations: Pursuant to I hereby determine that the objects to be the authority vested in me by the Act of • Send paper comments in triplicate included in the exhibition ‘‘Balthus: October 19, 1965 (79 Stat. 985; 22 U.S.C. Cats and Girls—Paintings and to Elizabeth M. Murphy, Secretary, 2459), Executive Order 12047 of March Securities and Exchange Commission, Provocations,’’ imported from abroad for 27, 1978, the Foreign Affairs Reform and temporary exhibition within the United 100 F Street NE., Washington, DC Restructuring Act of 1998 (112 Stat. 20549–1090. States, are of cultural significance. The 2681, et seq.; 22 U.S.C. 6501 note, et objects are imported pursuant to loan All submissions should refer to File seq.), Delegation of Authority No. 234 of agreements with the foreign owners or Number SR–OCC–2013–11. This file October 1, 1999, and Delegation of custodians. I also determine that the number should be included on the Authority No. 236–3 of August 28, 2000, exhibition or display of the exhibit subject line if email is used. To help the I hereby determine that the objects to be objects at the Metropolitan Museum of Commission process and review your included in the exhibition ‘‘Heaven and Art, New York, New York, from on or comments more efficiently, please use Earth: Art of Byzantium from Greek about September 23, 2013, until on or only one method of submission. The Collections,’’ imported from abroad for about January 12, 2014, and at possible Commission will post all comments on temporary exhibition within the United additional exhibitions or venues yet to the Commission’s Internet Web site States, are of cultural significance. The be determined, is in the national (http://www.sec.gov/rules/sro.shtml). objects are imported pursuant to loan interest. I have ordered that Public Copies of the submission, all subsequent agreements with the foreign owners or Notice of these Determinations be amendments, all written statements custodians. I also determine that the published in the Federal Register. with respect to the proposed rule exhibition or display of the exhibit FOR FURTHER INFORMATION CONTACT: For change that are filed with the objects at the National Gallery of Art, further information, including a list of Commission, and all written Washington, DC, from on or about the exhibit objects, contact Paul W. communications relating to the October 6, 2013, until on or about Manning, Attorney-Adviser, Office of proposed rule change between the March 2, 2014, the J. Paul Getty the Legal Adviser, U.S. Department of Commission and any person, other than Museum, Los Angeles, California, from State (telephone: 202–632–6469). The those that may be withheld from the on or about April 9, 2014, until on or mailing address is U.S. Department of public in accordance with the about August 5, 2014, and at possible State, SA–5, L/PD, Fifth Floor (Suite provisions of 5 U.S.C. 552, will be additional exhibitions or venues yet to 5H03), Washington, DC 20522–0505. available for Web site viewing and be determined, is in the national printing in the Commission’s Public interest. I have ordered that Public Dated: July 29, 2013. Reference Section, 100 F Street NE., Notice of these Determinations be Ann Stock, Washington, DC 20549, on official published in the Federal Register. Assistant Secretary, Bureau of Educational and Cultural Affairs, Department of State. business days between the hours of FOR FURTHER INFORMATION CONTACT: For 10:00 a.m. and 3:00 p.m. Copies of such further information, including a list of [FR Doc. 2013–19079 Filed 8–6–13; 8:45 am] filing also will be available for the exhibit objects, contact Paul W. BILLING CODE 4710–05–P inspection and copying at the principal Manning, Attorney-Adviser, Office of office of OCC and on OCC’s Web site at the Legal Adviser, U.S. Department of http://www.theocc.com/components/ DEPARTMENT OF STATE _ _ State (telephone: 202–632–6469). The docs/legal/rules and bylaws/ [Public Notice 8411] _ _ _ mailing address is U.S. Department of sr occ 13 11.pdf. State, SA–5, L/PD, Fifth Floor (Suite All comments received will be posted 5H03), Washington, DC 20522–0505. Culturally Significant Objects Imported without change; the Commission does for Exhibition Determinations: ‘‘Wols: not edit personal identifying Dated: July 30, 2013. Retrospective’’ information from submissions. You Ann Stock, SUMMARY: should submit only information that Assistant Secretary, Bureau of Educational Notice is hereby given of the you wish to make available publicly. and Cultural Affairs, Department of State. following determinations: Pursuant to the authority vested in me by the Act of All submissions should refer to File [FR Doc. 2013–19086 Filed 8–6–13; 8:45 am] October 19, 1965 (79 Stat. 985; 22 U.S.C. Number SR–OCC–2013–11 and should BILLING CODE 4710–05–P be submitted on or before August 28, 2459), Executive Order 12047 of March 2013. 27, 1978, the Foreign Affairs Reform and DEPARTMENT OF STATE Restructuring Act of 1998 (112 Stat. For the Commission, by the Division of 2681, et seq.; 22 U.S.C. 6501 note, et Trading and Markets, pursuant to delegated [Public Notice 8410] seq.), Delegation of Authority No. 234 of Authority.12 October 1, 1999, and Delegation of Kevin M. O’Neill, Culturally Significant Objects Imported for Exhibition Determinations: Authority No. 236–3 of August 28, 2000, Deputy Secretary. I hereby determine that the objects to be [FR Doc. 2013–19040 Filed 8–6–13; 8:45 am] ‘‘Balthus: Cats and Girls—Paintings and Provocations’’ included in the exhibition ‘‘Wols: BILLING CODE 8011–01–P Retrospective,’’ imported from abroad SUMMARY: Notice is hereby given of the for temporary exhibition within the 12 17 CFR 200.30–3(a)(12). following determinations: Pursuant to United States, are of cultural

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significance. The objects are imported United Nations Recommendations on SUMMARY: The FAA proposes to rule and pursuant to loan agreements with the the transport of dangerous goods invites public comment on the release of foreign owners or custodians. I also —Revision of the guidelines for packing land at the Ottumwa Regional Airport, determine that the exhibition or display of cargo transport units Ottumwa, Iowa, under the provisions of of the exhibit objects at The Menil —Development of amendments to 49 U.S.C. 47107(h)(2). Collection, Houston, Texas, from on or SOLAS and the relevant codes DATES: Comments must be received on about September 12, 2013, until on or concerning mandatory carriage of or before September 6, 2013. about January 12, 2014, and at possible appropriate atmosphere testing ADDRESSES: Comments on this additional exhibitions or venues yet to instruments on board ships application may be mailed or delivered be determined, is in the national —Casualty and incident reports and to the FAA at the following address: interest. I have ordered that Public analysis Lynn D. Martin, Airports Compliance Notice of these Determinations be —Biennial agenda and provisional Specialist, Federal Aviation published in the Federal Register. agenda for DSC 19 Administration, Airports Division, FOR FURTHER INFORMATION CONTACT: For —Any other business ACE–610C, 901 Locust Room 364, further information, including a list of —Report ot the Maritime Safety Kansas City, MO 64106. the exhibit objects, contact Paul W. Committee In addition, one copy of any Manning, Attorney-Adviser, Office of Members of the public may attend comments submitted to the FAA must the Legal Adviser, U.S. Department of this meeting up to the seating capacity be mailed or delivered to: Tom Francis, State (telephone: 202–632–6469). The of the room. To facilitate the building Airport Manager, C/O Ottumwa mailing address is U.S. Department of security process, and to request Regional Airport 14802 Terminal St. State, SA–5, L/PD, Fifth Floor (Suite reasonable accommodation, those who Ottumwa, IA 50501, 641–683–0619. 5H03), Washington, DC 20522–0505. plan to attend should contact the FOR FURTHER INFORMATION CONTACT: Dated: July 30, 2013. meeting coordinator, Ms. Amy Parker, Lynn D. Martin, Airports Compliance Ann Stock, by email at [email protected], by Specialist, Federal Aviation phone at (202) 372–1423, by fax at (202) Assistant Secretary, Bureau of Educational Administration, Airports Division, and Cultural Affairs, Department of State. 372–1925, or in writing at Commandant ACE–610C, 901 Locust Room 364, (CG–ENG–5), U.S. Coast Guard, 2100 Kansas City, MO 64106, (816) 329–2644, [FR Doc. 2013–19084 Filed 8–6–13; 8:45 am] 2nd Street SW., Stop 7126, Washington, [email protected]. BILLING CODE 4710–05–P DC 20593–7126 not later than August The request to release property may 20, 2013, 7 days prior to the meeting. be reviewed, by appointment, in person DEPARTMENT OF STATE Requests made after August 20, 2013 at this same location. might not be able to be accommodated. SUPPLEMENTARY INFORMATION: The FAA [Public Notice 8413] Please note that due to security invites public comment on the request considerations, two valid, government to release approximately 2.21 acres of Shipping Coordinating Committee; issued photo identifications must be airport property, Lot #6, at the Ottumwa Notice of Committee Meeting presented to gain entrance to the Regional Airport (OTM) under the Headquarters building. The provisions of 49 U.S.C. 47107(h)(2). On The Shipping Coordinating Headquarters building is accessible by January 2, 2013, the Airport Manager at Committee (SHC) will conduct an open taxi and privately owned conveyance the Ottumwa Regional Airport requested meeting at 9:30 a.m. on Tuesday, August (public transportation is not generally from the FAA that approximately 2.21 27, 2013, in Room 1303 of the United available). However, parking in the acres of property, Lot #6, be released for States Coast Guard Headquarters vicinity of the building is extremely sale to Al-Jon for use as a light Building, 2100 Second Street SW., limited. Additional information manufacturing operation. On July 16, Washington, DC 20593–0001. The regarding this and other IMO SHC 2013, the FAA determined that the primary purpose of the meeting is to public meetings may be found at: request to release property at the prepare for the eighteenth Session of the www.uscg.mil/imo. Ottumwa Regional Airport (OTM) International Maritime Organization’s Dated: July 31, 2013. submitted by the Sponsor meets the (IMO) Sub-Committee on Dangerous procedural requirements of the Federal Goods, Solid Cargoes and Containers Marc Zlomek, Executive Secretary, Shipping Coordinating Aviation Administration and the release (DSC 18) to be held at the IMO of the property does not and will not Headquarters, United Kingdom, Committee, Department of State. [FR Doc. 2013–19083 Filed 8–6–13; 8:45 am] impact future aviation needs at the September 16–20, 2013. airport. The FAA may approve the BILLING CODE 4710–09–P The agenda items to be considered request, in whole or in part, no sooner include: than thirty days after the publication of —Adoption of the agenda this Notice. —Decisions of other IMO bodies DEPARTMENT OF TRANSPORTATION The following is a brief overview of —Review of general cargo ship safety the request: —Development of amendments to CSC Federal Aviation Administration Ottumwa Regional Airport (OTM) is 1972 and associated circulars proposing the release of one parcel, Lot —Development of measures to prevent Notice of Request To Release Airport #6, containing 2.21 acres, more or less. loss of containers Property The release of land is necessary to —Development of amendments to the AGENCY: Federal Aviation comply with Federal Aviation IMSBC Code and supplements, Administration (FAA), DOT. Administration Grant Assurances that including evaluation of properties of do not allow federally acquired airport ACTION: Notice of intent to rule on solid bulk cargoes property to be used for non-aviation request to release airport property at the —Development of amendments to the purposes. The sale of the subject Ottumwa Regional Airport (OTM), IMDG Code and supplements, property will result in the land at the Ottumwa, Iowa. including harmonization with the Ottumwa Regional Airport (OTM) being

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changed from aeronautical to non- this document. All comments received notice grants AASHTO’s request and aeronautical use and release the lands will be available for examination and extends the deadline by 30 calendar from the conditions of the Airport copying at the above address from 9 days to September 8, 2013. Improvement Program Grant Agreement a.m. to 5 p.m., e.t., Monday through Issued on: August 2, 2013. Grant Assurances. In accordance with Friday, except Federal holidays. Those Victor M. Mendez, 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the desiring notification or receipt of FHWA Administrator. airport will receive fair market value for comments must include a self- the property, which will be addressed, stamped postcard or you [FR Doc. 2013–19176 Filed 8–5–13; 4:15 pm] subsequently reinvested in another may print the acknowledgment page BILLING CODE 4910–22–P eligible airport improvement project for that appears after submitting comments general aviation facilities at the electronically. You may review DOT’s DEPARTMENT OF TRANSPORTATION Ottumwa Regional Airport. complete Privacy Act Statement in the Any person may inspect, by Federal Register published on April 11, Federal Railroad Administration appointment, the request in person at 2000 (Volume 65, Number 70, Page the FAA office listed above under FOR 19477–78). [FRA Emergency Order No. 28, Notice No. FURTHER INFORMATION CONTACT. In FOR FURTHER INFORMATION CONTACT: Mr. 1] addition, any person may, upon Gerald Yakowenko, Contract appointment and request, inspect the Administration Team Leader, Office of Emergency Order Establishing application, notice and other documents Program Administration, (202) 366– Additional Requirements for determined by the FAA to be related to 1562, or Mr. Michael Harkins, Office of Attendance and Securement of Certain the application in person at the the Chief Counsel, (202) 366–4928, Freight Trains and Vehicles on Ottumwa Regional Airport. Federal Highway Administration, 1200 Mainline Track or Mainline Siding Issued in Kansas City, MO on July 26, New Jersey Avenue SE., Washington, Outside of a Yard or Terminal 2013. DC 20590. Office hours are from 8 a.m. The Federal Railroad Administration Jim A. Johnson, to 4:30 p.m., e.t., Monday through (FRA) of the United States Department Manager, Airports Division. Friday, except Federal holidays. of Transportation (DOT) has determined [FR Doc. 2013–19003 Filed 8–6–13; 8:45 am] SUPPLEMENTARY INFORMATION: that public safety compels issuance of BILLING CODE 4910–13–P Electronic Access and Filing this Emergency Order (EO), which requires railroads operating on the This document and all comments general system to implement additional DEPARTMENT OF TRANSPORTATION received may be viewed online through processes and procedures to ensure that the Federal eRulemaking portal at: certain unattended trains and vehicles 1 Federal Highway Administration http:www.regulations.gov. on mainline track or mainline siding [FHWA Docket No. FHWA–2013–0041] Regulations.gov is available 24 hours outside of a yard or terminal are each day, 365 days each year. Electronic properly secured against unintended Buy America Policy submission and retrieval help and movement. FRA re-examined its guidelines are available under the help regulations governing the securement of AGENCY: Federal Highway section of the Web site. An electronic Administration (FHWA), DOT. such equipment in light of the July 6, copy of this document may also be 2013, derailment in Lac-Me´gantic, ACTION: Notice of extension of deadline. downloaded by accessing the Office of Quebec, Canada, which demonstrated the Federal Register’s home page at: SUMMARY: The FHWA is extending the the terrible consequences that can arise deadline for comments regarding the http://www.archives.gov/federal- when a railroad accident results in a continued need, in whole or in part, for register/, or the Government Printing sudden release of flammable liquids. the general waivers from Buy America Office’s Web page at: http:// FRA’s inspection data since January for manufactured products; for ferry www.gpo.gov/fdsys. 2010 shows significant non-compliance boat equipment; and for pig iron and Background with FRA’s securement regulations, 49 processed, pelletized, and reduced iron CFR 232.103(n), with nearly 4,950 On July 10, 2013, at 78 FR 41492, the ores, which was published on July 10, recorded defects in that time. Moreover, FHWA published in the Federal 2013. The original deadline for FRA has seen a number of serious Register a notice seeking comments submitting comments was August 9, accidents during rail transportation of regarding the continued need, in whole 2013. This notice extends the deadline flammable liquids since 2009, and there or in part, for the general waivers from by 30 calendar days to September 8, has been significant growth in these Buy America for manufactured 2013. types of rail shipments since 2011. products; for ferry boat equipment; and These factors lead FRA to the DATES: Comments must be received on for pig iron and processed, pelletized, conclusion that additional action is or before September 8, 2013. Late filed and reduced iron ores. This notice also necessary to eliminate an immediate comments will be considered to the sought comment on the continuing need hazard of death, personal injury, or extent practicable. for the FHWA’s minimal use threshold significant harm to the environment, ADDRESSES: Mail or hand deliver (currently established at $2,500 or 1/10 particularly in instances where certain comments to the U.S. Department of of 1 percent of the total contract value, hazardous materials are involved. As a Transportation, Dockets Management whichever is greater). The original result, FRA is ordering that each Facility, Room W12–140, 1200 New deadline for comments was August 8, railroad take the following actions on Jersey Avenue SE., Washington, DC 2013. In a letter dated July 23, 2013, the mainline track or mainline siding 20590, or submit electronically at American Association of State Highway outside of a yard or terminal to ensure http://www.regulations.gov or fax and Transportation Officials (AASHTO) comments to (202) 493–2251. All submitted a comment to the docket for 1 A vehicle, as defined in 49 U.S.C. 20301, comments should include the docket this notice requesting a 30-day ‘‘means a car, locomotive, tender, or similar number that appears in the heading of extension to submit comments. This vehicle.’’

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the safe transportation by rail of 5. Develop procedures to ensure that train unattended on mainline track with hazardous material: a qualified railroad employee inspects a descending grade of approximately 1.2 1. No train or vehicle transporting all equipment that any emergency percent. hazardous materials as described in responder has been on, under, or At around 11:50 p.m. a local resident Appendix A shall be left unattended on between for proper securement before reported a fire on the controlling a mainline track or mainline siding the train or vehicle is left unattended. locomotive (MMA 5017) of the train. outside of a yard or terminal until the Additionally, each railroad must The local fire department was called railroad develops, adopts, complies provide notice of this EO to all and responded with another MMA with and makes available to FRA upon employees affected by this EO to ensure employee. At approximately midnight, request, a plan that identifies specific that they have knowledge of the EO’s the controlling locomotive was shut locations and circumstances when such requirements. down and the fire extinguished. After trains or vehicles may be left the fire was extinguished, the fire Authority unattended. The plan shall contain a department and the MMA employee left sufficient safety justification for any Authority to enforce Federal railroad the site. determination allowing such trains or safety laws has been delegated by the At approximately 1:00 a.m. the next vehicles to be unattended. FRA will Secretary of Transportation to the day (the early morning of July 6th) it monitor such plans and if FRA Administrator of FRA. 49 CFR 1.89. appears that the train began rolling and determines that adequate justification is Railroads are subject to FRA’s safety picking up speed down the descending not provided, the railroad shall ensure jurisdiction under the Federal railroad grade toward the town of Lac-Me´gantic, that trains and equipment are attended safety laws. 49 U.S.C. 20101, 20103. Quebec, which sits approximately 30 until appropriate modifications to the FRA is authorized to issue emergency miles from the United States-Canada plan are completed. FRA does not orders where an unsafe condition or border. Near the center of town, the box intend to grant approval to any plan. practice ‘‘causes an emergency situation car and 63 of the loaded tank cars Each railroad shall notify FRA when it involving a hazard of death, personal derailed. The locomotives, which has developed a plan under this injury, or significant harm to the separated from the train, traveled an provision prior to the railroad operating environment.’’ 49 U.S.C. 20104. These additional 1⁄2 mile before coming to a pursuant to the plan. orders may immediately impose stop. A number of derailed tank cars 2. Develop processes for the ‘‘restrictions and prohibitions . . . that released product resulting in multiple securement of unattended trains or may be necessary to abate the explosions and subsequent fires. At this vehicles transporting hazardous situation.’’ Id. time, it is estimated that there were 42 materials as described in Appendix A Lac-Me´gantic Derailment fatalities and that 5 persons are still on mainline track or mainline siding missing. There was also extensive FRA has re-examined its requirements outside of a yard or terminal if damage to the town, and approximately for securing trains and vehicles on permitted by the railroad’s plan 2,000 people were evacuated from the mainline track and mainline sidings required by this order that contains the surrounding area. While the outside of a yard or terminal in the following requirements: investigation is ongoing and the aftermath of the catastrophic July 6, a. The controlling locomotive cab Transportation Safety Board of Canada 2013, accident involving loaded tank must be locked or the reverser on the has not reached any final conclusions, cars containing petroleum crude oil that controlling locomotive must be removed it has made a determination that the occurred in the town of Lac-Me´gantic, and secured, and braking force applied to the train was Quebec, Canada, on track owned by b. Employees who are responsible for insufficient to hold it on the 1.2-percent Montreal, Maine & Atlantic Railway securing trains and vehicles descending slope between Nantes and Corporation (MMA), a company transporting hazardous materials as Lac-Me´gantic. described in Appendix A must incorporated in the United States. While In response to this accident, Transport communicate to the train dispatcher the Canadian authorities are still Canada (the Canadian government number of hand brakes applied, the investigating the accident and no final department responsible for regulating tonnage and length of the train or conclusions have been made, the transportation safety in Canada) issued vehicle, the grade and terrain features of following is known based on an emergency railroad directive the track, any relevant weather preliminary information released by the pursuant to Section 33 of the Canadian conditions, and the type of equipment Transportation Safety Board of Canada. Railway Safety Act.2 While Transport According to Rail Safety Advisory being secured; train dispatchers must Canada explained in the emergency Letters issued by the Transportation record the information provided; and directive that the cause of the accident Safety Board of Canada on July 19, 2013, train dispatchers or other qualified in Lac-Me´gantic remains unknown, the the incident is summarized as follows. railroad employees must verify and emergency directive stated that: confirm with the train crew that the At approximately 10:45 p.m. Eastern [I]n light of the catastrophic results of the securement meets the railroad’s Daylight Time (EDT) on July 5, 2013, Lac-Me´gantic accident and in the interest of requirements. MMA train 2 was proceeding eastward ensuring the continued safety and security of 3. Review and verify, and adjust, as from Montreal, Quebec, to St. John, New railway transportation, there is an immediate necessary, existing procedures and Brunswick. The train was need to clarify the regime respecting processes related to the number of hand approximately 4,700 feet long and unattended locomotives on main track and brakes to be set on all unattended trains weighed over 10,000 tons. It consisted sidings and the transportation of dangerous and vehicles and ensure the means of of five locomotives, a loaded box car, 2 Available online at: http://www.tc.gc.ca/eng/ verifying that number is appropriate. and 72 loaded tank cars containing mediaroom/backgrounders-safety-locomotives- 4. Implement operating rules and petroleum crude oil (U.S. DOT Hazard 7292.html. Additionally, in response to this practices requiring the discussion of Class 3, UN 1267). At approximately accident, the Transportation Safety Board of Canada securement for any job that will impact 11:00 p.m. the train stopped near issued Rail Safety Advisory Letter—09/13 regarding the securement of equipment and trains left or require the securement of any train or milepost 7.40 near Nantes, Quebec. At unattended; available online at: http:// vehicle in the course of the work being that location the operator of the train www.tsb.gc.ca/eng/medias-media/sur-safe/letter/ performed. secured it and departed, leaving the rail/2013/r13d0054/r13d0054-617-09-13.asp.

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goods in tank cars using a one person crew include the following: Reviewing the being transported by rail is classified as to address any threat to the safety and details and lessons learned from the flammable.4 security of railway operations. Lac-Me´gantic accident; reviewing crew The MMA train in the Lac-Me´gantic As such, Transport Canada exercised staffing levels; removing and securing incident was transporting 72 carloads of its statutory emergency directive the train’s ‘‘reverser’’ when unattended; petroleum crude oil with five authority to order railroad companies a thorough review of all railroad locomotives and a loaded box car. A operating in Canada to comply with operating procedures, testing and similar type of train consist is certain requirements related to operating rules around securing a train; commonly found on rail lines in the unauthorized entry into locomotive reviewing Transport Canada’s directives United States because crude oil is often cabs, directional controls on to secure and safely operate a train; and transported in units of cars or by a unit locomotives, the application of hand conducting a system-wide assessment of train consisting virtually entirely of tank brakes to cars left unattended for more security risks when a train is cars containing crude oil. Crude oil is than one hour, setting of the automatic unattended and identifying mitigation often classified by an offeror as a brake and independent brake on any efforts for those risks. Additionally, the flammable liquid; per PHMSA’s Hazmat locomotive attached to cars that is left Safety Advisory recommends testing Regulations (HMR), however, its unattended for one hour or less, and sampling of crude oil for proper packing group can be I, II, or III attendance related to locomotives classification for shipment, as well as a depending on the blend of constituent attached to loaded tank cars review of all shippers’ and carriers crude oils. According to the Association transporting dangerous goods on main safety and security plans. Finally, FRA of American Railroads (AAR), crude oil track, and the number of crew members is convening an emergency meeting of traffic increased 443 percent in the assigned to a locomotive attached to FRA’s Railroad Safety Advisory United States between 2005 and 2012. loaded tank cars transporting dangerous Committee to begin the deliberative Much of this growth has occurred goods on a main track or siding. process with FRA’s stakeholders, because of developments in North In addition, Transport Canada issued including railroad management, railroad Dakota, as the Bakken formation in the an accompanying order pursuant to labor, shippers, car owners, and others, Williston Basin has become a major paragraph 19(a)(1) of the Canadian as the agency considers source for oil production in the United Railway Safety Act directing railroad recommendations in the Safety States. Texas also has contributed to the companies in Canada to formulate or Advisory that should be made a part of growth of crude oil shipments by rail. revise certain railroad operating rules, its regulations. As a result, carloads of crude oil respecting the safety and security of increased from approximately 65,600 in unattended locomotives, uncontrolled Safety Concerns Arising Out of the Lac- Me´gantic Derailment 2011 to approximately 257,450 in 2012. movements, and crew size The Bakken crude oil from North Dakota requirements. The order provides that Generally, the transportation of is primarily shipped via rail to refineries rules should be based on an assessment hazardous materials by rail is extremely located near the U.S. Gulf Coast— safe. The vast majority of hazardous of safety and security risks, and shall at particularly in Texas and Louisiana—or materials shipped by rail each year a minimum ensure that the cab(s) of also to pipeline connections, most arrive at their destinations safely and unattended controlling locomotives are notably to connections located in without incident. Indeed, in calendar secure against unauthorized entry; Oklahoma. Crude oil is also shipped via year 2011, there were only 20 accidents ensure that the reversers of unattended rail to refineries on the East Coast and, in which a hazardous material was locomotives are removed and secured; to a lesser extent, refineries in other released out of approximately 2.2 prevent uncontrolled movements of regions of the U.S.5 million shipments of hazardous material railway equipment by addressing the All indications from the U.S. Energy transported by rail in the United States. application of hand brakes; ensure the Information Administration (EIA) However, the Lac-Me´gantic incident security of stationary railway equipment within the U.S. Department of Energy demonstrates the substantial potential transporting dangerous goods; and are that rail export capacity for Bakken for danger that exists when an provide for minimum operating crew crude oil from the Williston Basin will unattended train rolls away and derails requirements considering technology, continue to expand to meet production.6 length of train, speeds, classification of resulting in the sudden release of hazardous materials into the dangerous goods being transported, and 4 PHMSA prescribes a comprehensive regulatory other risk factors. environment. Although the Lac- safety system that categorizes hazardous materials DOT is taking actions consistent with Me´gantic incident occurred in Canada, into nine hazard classes based on the type of Transport Canada to ensure the safe the freight railroad operating hazards presented by the materials. See 49 CFR transportation of products by rail in the environment in Canada is similar to that Parts 172 and 173. Under PHMSA’s regulations, crude oil, in most forms, meets the definition of a United States, with a particular focus on in the United States, and a number of ‘‘Class 3’’ hazardous material, which signifies that certain hazardous materials that present railroads operate in both countries.3 it is a flammable liquid. Ethanol, discussed below, an immediate danger for communities Freight railroads in the United States also is a Class 3 hazardous material. PIH materials, and the environment in the event of a also transport a substantial amount and referenced above, include ‘‘Class 2 and Division 2.3’’ gases and ‘‘Class 6, and Division 6.1’’ poisons train accident. Through this EO, FRA is variety of hazardous materials, other than gases. Chlorine gas and anhydrous addressing the immediate dangers that including materials poisonous by ammonia are two examples of PIH materials arise from unattended equipment that is inhalation (PIH), materials or toxic by (Division 2.3) that are commonly transported by left unsecured. Additionally, FRA and inhalation (TIH), and explosive rail. the Pipeline and Hazardous Materials materials. Moreover, an increasing 5 See AAR’s May 2013 paper ‘‘Moving Crude Oil by Rail’’ available online at: https://www.aar.org/ Safety Administration (PHMSA) are proportion of the hazardous materials keyissues/Documents/Background-Papers/Crude- issuing a joint Safety Advisory to oil-by-rail.pdf. railroads and commodity shippers 3 As an example, MMA operates both in the 6 See EIA reports ‘‘Bakken crude oil price detailing eight recommended actions United States and Canada, with approximately 510 differential to WTI narrows over last 14 months,’’ miles of track in Maine, Vermont, and Quebec, and available online at: http://www.eia.gov/ the industry should take to better ensure the tank cars transporting the crude oil that derailed todayinenergy/detail.cfm?id=10431; and ‘‘Rail the safe transport of hazardous in Lac-Me´gantic originated in the Williston Basin of delivery of U.S. oil and petroleum products materials. These recommendations North Dakota. continues to increase, but pace slows,’’ available

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Rail exports from the North Dakota evacuation of a one-mile radius around • On January 6, 2005, in Graniteville, region are forecast to increase over the the derailment. SC, a Norfolk Southern train collided next two years (as are pipeline exports). • On July 11, 2012, in Columbus, OH, with another Norfolk Southern train that Much of the near-term growth in rail a Norfolk Southern train derailed while was parked on a customer side track, originations right now is a function of operating on main track. Thirteen tank derailing both locomotives and 16 cars how quickly tank car manufacturers can cars containing ethanol derailed of the moving train. The accident was produce new cars to meet the demand resulting in a fire and the evacuation of caused by a misaligned switch. Three for tank cars, primarily for transporting 100 people within a one-mile radius of tank cars containing chlorine derailed, Bakken crude oil. The rise in rail the derailment. one of which was punctured. The • originations in crude oil is subject to On August 5, 2012, in Plevna, MT, resulting chlorine exposure caused 9 changes in the number of tank cars a BNSF Railway Co. train derailed 18 deaths, approximately 554 people were available, price of crude oil, and overall cars while en route from Baker, MT. taken to local hospitals, and an production of crude oil in that region, Seventeen of the 18 cars were tank cars additional 5,400 people within a one- and is also dependent on whether, or loaded with denatured alcohol, a form mile radius of the site were evacuated how quickly, additional pipeline export of ethanol. Five of the cars caught on by law enforcement personnel. FRA’s capacity from that region comes online. fire resulting in explosions, the burning analysis of the total cost of the accident However, for the foreseeable future, all of surrounding property not within the was $126 million, including fatalities, indications are for continued growth of railroad’s right-of-way, and the injuries, evacuation costs, property rail originations of crude in that region evacuation of the immediate area. damage, environmental cleanup, and as new tank car fleets come online to Although these accidents were track out of service. meet demand. serious, their results had potential for While train accidents involving more catastrophic outcomes. The As demonstrated by the Lac-Me´gantic hazardous materials are caused by a catastrophic releases created the derailment, in a catastrophic incident, variety of factors, nearly one-half of all potential for additional deaths, injuries, crude oil is problematic when released accidents are related to railroad human property damage, and environmental factors or equipment defects. FRA’s data because it is flammable. This risk is damage. compounded because it is commonly shows that since 2009, human factors There are other hazardous materials have been the most common cause of shipped in large units. Similar dangers that have similar potential for exist with other hazardous materials reportable train accidents. Based on catastrophic danger. For example, FRA’s accident reporting data for the such as ethanol, which is another accidents involving trains transporting period from 2009 through 2012, 35.7 flammable liquid that is commonly other hazardous materials, including percent of train accidents were human transported by rail. More carloads of PIH materials, such as chlorine and factor-caused. With regard to the ethanol were transported via rail than anhydrous ammonia, can also result in securement of unattended equipment, any other hazardous material in 2012. serious consequences as evidenced by specifically, FRA accident data Ethanol experienced an increase in the following accidents: indicates that approximately 8.5 percent traffic of 442 percent between 2005 and • On July 18, 2001, 11 of 60 cars in of human factor-caused train accidents 2010. Although in 2012 the number of a CSX Transportation, Inc. freight train from calendar year 2011 until April carloads dropped by 11 percent from derailed while passing through the 2013 were the result of improper 2010 levels, there were still Howard Street Tunnel in downtown securement. This EO is intended to approximately 366,000 carloads Baltimore, MD. The train included 8 address some of the human factors transported by rail. Since 2009, there tank cars loaded with hazardous failures that may cause unattended have been at least four serious mainline material; 4 of these were among the cars equipment to be improperly secured to derailments resulting in the breach of that derailed. A leak in a tank car protect against a derailment situation tank cars containing ethanol. While FRA containing tripropylene resulted in a similar to that which occurred in Lac- recognizes that none of these four chemical fire. A break in a water main Me´gantic. derailments resulted from a roll-away above the tunnel flooded both the situation, they are instructive on the tunnel and the streets above it, resulting Securement Requirements destructive potential of a derailment in the tunnel collapsing. As previously noted, FRA has issued involving tank cars containing • On January 18, 2002, a Canadian regulations designed to ensure that flammable products: Pacific Railway train containing 15 tank trains and vehicles are properly secured • On June 19, 2009, in Cherry Valley, cars of anhydrous ammonia derailed before being left unattended. See IL, a Canadian National Railway train half a mile from the city limits of Minot, § 232.103(n). ‘‘Unattended equipment’’ derailed 19 tank cars loaded with ND due to a breaking of the rail at a is defined as ‘‘equipment left standing ethanol. Thirteen of the 19 derailed cars joint. Five of these tank cars ruptured and unmanned in such a manner that caught fire, and there were reports of catastrophically, resulting in an the brake system of the equipment explosions. One person died, and there ammonia vapor that spread 5 miles cannot be readily controlled by a were 9 reported injuries related to the downwind over an area where 11,600 qualified person.’’ Id. Section fire. Additionally, approximately 600 people lived. The accident caused one 232.103(n) addresses the securement of residences were evacuated within a 1⁄2- death, 11 serious injuries, and 322 unattended equipment by stating that a mile radius of the derailment. minor injuries. Environmental cleanup train’s air brakes must not be depended • On February 6, 2011, in Arcadia, costs reported to the National on to hold equipment standing OH, a Norfolk Southern Railway Co. Transportation Safety Board (NTSB) unattended on a grade and further (Norfolk Southern) train operating on were $8 million. requires the application of a sufficient single main track derailed 33 tank cars • On June 28, 2004, near Macdona, number of hand brakes to hold the loaded with ethanol. The derailment TX, a Union Pacific Railroad Company equipment with the air brakes released caused a major fire and forced the train passed a stop signal and collided and the ventilation of the brake pipe with a BNSF train. A chlorine car was pressure to zero with the angle cock online at: http://www.eia.gov/todayinenergy/ punctured and the chlorine gas that was opened on one end of a cut of cars when detail.cfm?id=12031. released killed three and injured 32. not connected to a locomotive or other

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compressed air source. The regulations complies with a plan that identifies the foreman of engines, or another train also require railroads to develop a specific locations and circumstances for crew employee) will be in a position to process or procedure for verifying that which it is safe and suitable for leaving ensure that a sufficient number of hand the hand brakes that are applied are such trains or vehicles unattended. The brakes have been applied. sufficient to hold the equipment with plan must contain sufficient analysis of Third, this E.O. requires that railroads the air brakes released. When dealing the safety risks and any mitigating review, verify, and adjust, as necessary, with locomotives and locomotive circumstances the railroad has existing requirements and instructions consists, § 232.103(n)(3) establishes considered in making its determination. related to the number of hand brakes to specific additional requirements: FRA does not intend to grant approval be set on unattended trains and vehicles • All hand brakes must be fully to any plan, per se. However, FRA will and that railroads review and adjust, as applied on all locomotives in the lead monitor such plans and if FRA necessary, the procedures for verifying consist of an unattended train. determines that adequate justification is that the number of hand brakes is • All hand brakes must be fully not provided, the railroad shall ensure sufficient to hold the train or vehicle applied on all locomotives in an that trains and equipment are attended with the air brakes released. FRA’s unattended locomotive consist outside until appropriate modifications are concern is that existing railroad of yard limits. made to the railroad’s plan. processes and procedures related to • The minimum requirement for an setting and verifying hand brakes on unattended locomotive consist within Second, FRA is requiring railroads to develop specific processes for unattended trains and equipment may yard limits is that the hand brake must not be sufficient to hold all trains and employees responsible for securing any be fully applied on the controlling vehicles in all circumstances. FRA unattended train or vehicles locomotive. expects that the procedures and number transporting hazardous materials as • Railroads must develop, adopt, and of hand brakes required to be set will described in Appendix A that must be comply with procedures for securing vary significantly, depending on a left on mainline track or a mainline any unattended locomotive that is not variety of factors, including, but not siding outside of a yard or terminal. The equipped with an operative hand brake. limited to: The length and weight of the employees responsible for securing the Additionally, FRA requires each train or vehicle(s), the location, the train or vehicles must lock the railroad to adopt and comply with grade and other terrain features of the controlling locomotive cab door before instructions addressing the throttle track, the weather conditions, the type position, status of the reverse lever leaving it unattended or remove and of equipment being secured, and (commonly referred to as a ‘‘reverser’’), secure the reverser. The reverser is the whether the hand brakes apply on one position of the generator field switch, directional control for the locomotive. or more trucks of a piece of equipment. status of the independent brakes, Removing it would put the locomotive The procedures should also ensure that position of the isolation switch, and in neutral, preventing it from moving an additional margin of safety is position of the automatic brake valve of forward or backward under the power of provided when determining the number an unattended locomotive. See the engine. Additionally, employees of hand brakes to be set in order to § 232.103(n)(4). must communicate to the train compensate for the differing ability of In FRA’s view, these regulations— dispatcher the number of hand brakes individuals to set a hand brake at a when followed—substantially reduce applied, the tonnage of the train or specified level. FRA also expects the risk of movement of unattended vehicle, the grade and terrain features of railroads to develop appropriate equipment. However, FRA has found the track, any other relevant weather procedures to be followed by their there is significant non-compliance conditions, and the type of equipment employees to test or verify that the among the railroads with respect to being secured. The dispatcher is then number of hand brakes set will hold the FRA’s securement regulations. With required to record the information equipment with the air brakes released. limited resources, FRA can inspect only provided by the employee. Finally, the Fourth, this E.O. requires railroads to a small percentage of trains and vehicles dispatcher or other qualified railroad implement operating rules and practices for regulatory compliance. However, employee must verify and confirm with requiring the job briefing of securement even with its limited resources, FRA has the train crew that the securement meets among crewmembers and other recorded nearly 4,950 securement the railroad’s requirements. This involved railroad employees before defects in the course of its inspections requirement provides a check on those engaging in any job that will impact or since January 2010, an average of individuals setting hand brakes to require the securement of any train or approximately 1,483 defects per year. ensure appropriate securement vehicle in the course of the work being With increased shipments of hazardous procedures are followed. The performed. This requirement is materials such as crude oil and ethanol, requirement is similar to FRA’s existing analogous to other Federal regulations securement non-compliance, regulations that require employees to that require crewmembers to have a job particularly on mainline track and report to the train dispatcher when a briefing before performing various tasks, mainline sidings outside of a yard or main track switch in non-signaled such as confirming the position of a terminal, has become a serious, territory has been restored to normal main track switch before leaving an immediate safety concern. Therefore, position and locked. FRA believes this area. The purpose of this job briefing additional measures are necessary to type of notification and verification requirement is to make certain that all protect the health and safety of railroad requirement will help ensure that crewmembers and other involved employees, the general public, and the employees responsible for securing railroad employees are aware of what is environment. equipment containing hazardous necessary to properly secure the First, in this EO, FRA is prohibiting materials will follow appropriate equipment in compliance with railroads from leaving trains or vehicles procedures because the employee will § 232.103(n). that are transporting hazardous need to fully consider the securement Finally, FRA is requiring railroads to materials as described in Appendix A procedures in order to relay what was develop procedures to ensure that a unattended on mainline track or done to the dispatcher. Further, the qualified railroad employee inspects all mainline siding outside of a yard or dispatcher or other qualified railroad equipment that any emergency terminal unless the railroad adopts and employee (e.g. a trainmaster, road responder has been on, under, or

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between for proper securement before are completed. FRA does not intend to Associate Administrator shall grant the rail equipment or train is left grant approval to any plan. Railroads petitions only in which a petitioner has unattended. One of the facts that has shall notify FRA when the railroad has clearly articulated an alternative action come to light in the aftermath of the developed a plan under this provision that will provide, in the Associate Lac-Me´gantic derailment is that first prior to the railroad operating pursuant Administrator’s judgment, at least a responders were at milepost 7.4 near to the plan. level of safety equivalent to that Nantes (along with an MMA employee) 2. Railroads shall develop processes provided by this E.O.. to check a report of a fire on the train. for securing unattended trains or This was well after the operator had vehicles transporting Appendix A Penalties secured the train and left it unattended. Materials on a mainline track or Any violation of this order or the Because it may be necessary for mainline siding outside of a yard or terms of any written plan adopted emergency responders to modify the terminal if permitted by the railroad’s pursuant to this order to provide state of the equipment if it is necessary plan required under paragraph (1) of alternate protection shall subject the for them to go on, under, or between this order that contains the following person committing the violation to a equipment in order to perform their requirements: civil penalty of up to $105,000. 49 jobs, it is critical for the railroad to have a. The controlling locomotive cab U.S.C. 21301. Any individual who a qualified employee inspect the must be locked or the reverser on the willfully violates a prohibition stated in equipment after the emergency controlling locomotive must be removed this order is subject to civil penalties responders have completed their jobs to and secured. under 49 U.S.C. 21301. In addition, ensure that the equipment is properly b. Employees who are responsible for such an individual whose violation of secured before it is again left securing trains and vehicles this order demonstrates the individual’s unattended. transporting Appendix A Materials must unfitness for safety-sensitive service communicate to the train dispatcher the Finding and Order may be removed from safety-sensitive number of hand brakes applied, the service on the railroad under 49 U.S.C. While FRA recognizes that the tonnage and length of the train or 20111. If appropriate, FRA may pursue transportation of hazardous materials by vehicle, the grade and terrain features of criminal penalties under 49 U.S.C. rail is extremely safe and that the vast the track, any relevant weather 522(a) and 49 U.S.C. 21311(a), as well majority of hazardous materials shipped conditions, and the type of equipment as 18 U.S.C. 1001, for the knowing and by rail each year arrive at their being secured; train dispatchers must willful falsification of a report required destinations safely and without record the information provided; and by this order. FRA may, through the incident, FRA finds that there are gaps train dispatchers or other qualified Attorney General, also seek injunctive in the regulatory scheme that create an railroad employees must verify and relief to enforce this order. 49 U.S.C. emergency situation involving a hazard confirm with the train crew that the 20112. of death, personal injury, or significant securement meets the railroad’s harm to the environment, with respect requirements. Effective Date and Notice to Affected to securement of unattended vehicles 3. Railroads shall review and verify, Persons and trains transporting a hazardous and adjust, as necessary, existing Upon issuance of this E.O., railroads material of the type described in procedures and processes related to the shall immediately initiate steps to Appendix A to this E.O. on mainline number of hand brakes to be set on all implement this E.O.. Railroads shall track and mainline sidings outside of a unattended trains and equipment and complete implementation no later than yard or terminal. Accordingly, pursuant shall ensure the means of verifying that September 1, 2013. Notice of this E.O. to the authority of 49 U.S.C. 20104, number is appropriate. will be provided by publishing it in the delegated to the FRA Administrator by 4. Railroads shall implement Federal Register. the Secretary of Transportation, 49 CFR operating rules and practices requiring 1.89, it is hereby ordered that each the job briefing of securement for any Review railroad must institute and carry out the job that will impact or require the Opportunity for formal review of this following measures, effective within 30 securement of any train or vehicle in the E.O. will be provided in accordance days after the date of this order: course of the work being performed. with 49 U.S.C. 20104(b) and section 554 1. No train or vehicles transporting 5. Railroads shall develop procedures of title 5 of the United States Code. the type and quantity of hazardous to ensure that a qualified railroad Administrative procedures governing materials described in Appendix A employee inspects all equipment that such review are found at 49 CFR part (Appendix A Materials) shall be left any emergency responder has been on, 211. See 49 CFR 211.47, 211.71, 211.73, unattended on a mainline track or under, or between for proper 211.75, and 211.77. mainline siding outside of a yard or securement before the train or vehicle is terminal until the railroad develops, left unattended. Issued in Washington, DC, on August 2, 2013. adopts, complies with and makes 6. Notice of this E.O. shall be available to FRA upon request a plan provided to all employees affected by Joseph C. Szabo, that identifies specific locations and this E.O.. Administrator. circumstances when such trains or Appendix A to Emergency Order 28 vehicles may be left unattended. The Relief plan shall contain a sufficient safety Petitions for special approval to take (1) Five or more tank car loads of any one justification for any determination actions not in accordance with this E.O. or any combination of materials poisonous by allowing such trains or vehicles to be may be submitted to the Associate inhalation as defined in 49 CFR 171.8, and including anhydrous ammonia (UN 1005) unattended. FRA will monitor such Administrator for Railroad Safety/Chief and ammonia solutions (UN 3318); or plans and if FRA determines that Safety Officer (Associate Administrator), (2) 20 rail car loads or intermodal portable adequate justification is not provided, who shall be authorized to dispose of tank loads of any one or any combination of the railroad shall ensure that trains and those requests without the necessity of materials listed in (1) above, or, any Division equipment are attended until amending this E.O.. In reviewing any 2.1 flammable gas, Class 3 flammable liquid appropriate modifications to the plan petition for special review, the or combustible liquid, Class 1.1 or 1.2

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explosive, or hazardous substance listed in 493–6047; or Charles Betts, Director, and came to a stop approximately 1⁄2 49 CFR 173.31(f)(2).7 Standards and Rulemaking Division, mile from the derailment site. The box [FR Doc. 2013–19215 Filed 8–6–13; 8:45 am] Office of Hazardous Materials Safety, car and 63 of the loaded tank cars BILLING CODE 4910–06–P PHMSA, 1200 New Jersey Avenue SE., derailed. A number of derailed tank cars Washington, DC 20590, telephone (202) released product resulting in multiple 366–8553. explosions and subsequent fires. At this DEPARTMENT OF TRANSPORTATION SUPPLEMENTARY INFORMATION: time, it is estimated that there were 42 fatalities and 5 persons are still missing. Federal Railroad Administration Incident Summary There was also extensive damage to the [Safety Advisory 2013–06] On July 6, 2013, a catastrophic town, and approximately 2,000 people accident involving a freight train were evacuated from the surrounding Pipeline and Hazardous Materials containing loaded tank cars of area. Safety Administration petroleum crude oil occurred in the ´ Transport Canada Emergency Directive [Docket No. PHMSA–2013–0196; Notice No. town of Lac-Megantic, Quebec, on the 13–13] Montreal, Maine & Atlantic Railway In response to this accident, Transport (MMA). While the accident is still being Canada (the Canadian government Lac-Me´gantic Railroad Accident investigated by Canadian authorities department responsible for regulating Discussion and DOT Safety and no final determinations have been transportation safety in Canada) issued Recommendations made, the following is known based on an emergency railroad directive preliminary information released by the pursuant to Section 33 of the Canadian AGENCY: Federal Railroad Transportation Safety Board of Canada.1 Railway Safety Act.2 The directive Administration (FRA) and Pipeline and According to Rail Safety Advisory ordered railroad companies in Canada Hazardous Materials Safety Letters issued by the Transportation to ensure that: Administration (PHMSA), Department Safety Board of Canada on July 19, 2013, • Within five days of the issuance of of Transportation (DOT). the incident is summarized as follows. the directive, all unattended controlling ACTION: Notice of Safety Advisory and At approximately 10:45 p.m. (EDT) on locomotives on a main track and sidings Announcement of Emergency Meeting July 5, 2013, an MMA train was are protected from unauthorized entry of the Railroad Safety Advisory proceeding eastward from Montreal, into the cab; Committee. Quebec, to St. John, New Brunswick. • The directional controls, commonly The train was approximately 4,700 feet known as reversers, are removed from SUMMARY: A recent catastrophic railroad long, weighed over 10,000 tons and any unattended locomotives, preventing accident occurred in Canada when an consisted of five locomotives, a loaded them from moving forward or backward, unattended freight train containing box car, and 72 loaded tank cars on a main track or sidings; hazardous materials rolled down a containing petroleum crude oil (Class 3, • Their company’s special descending grade and subsequently UN 1267). At approximately 11:00 p.m. instructions on hand brakes are applied derailed. It is currently estimated that the train stopped near mile post 7.40 to any locomotive attached to one or this accident resulted in 42 fatalities, near Nantes, Quebec. At that location more cars that are left unattended for and 5 persons are still reported to be the single operator secured the train and more than one hour on a main track or missing. In response, FRA issued departed, leaving the train unattended sidings; Emergency Order No. 28 regarding the on mainline track with a descending • In addition to complying with their securement of trains, and FRA and grade of approximately 1.2 percent. company’s special instructions on hand PHMSA (collectively, DOT) are also At approximately 11:50 p.m., a local brakes referred to in the item issuing this safety advisory. This safety resident reported a fire on the lead immediately above, the automatic brake advisory discusses the circumstances locomotive (MMA 5017) of the train and is set in full service position and the surrounding the accident and makes the local fire department was called and independent brake is fully applied for certain safety-related recommendations responded with another MMA any locomotive attached to one or more to railroads operating in the United employee. At approximately midnight, cars that are left unattended for one States. This safety advisory also in accordance with established hour or less on a main track or sidings; provides notice of FRA’s intent to operating procedures, the lead • No locomotive attached to one or schedule an emergency meeting of the locomotive was shut down and the fire more loaded tank cars transporting Railroad Safety Advisory Committee to extinguished. After the fire was dangerous goods is left unattended on a discuss this accident and potential extinguished, the fire department and main track; and regulatory actions to prevent similar the MMA employee left the site. • No locomotive attached to one or future accidents from occurring. At approximately 1:00 a.m. the next more loaded tank cars transporting FOR FURTHER INFORMATION CONTACT: day, it appears that the train began dangerous goods is operated on a main Thomas J. Herrmann, Acting Director, rolling and picking up speed down the track or siding with fewer than two Office of Safety Assurance and descending grade toward the town of persons qualified under their company’s Compliance, Office of Railroad Safety, Lac-Me´gantic, Quebec. Near the center requirements for operating employees. FRA, 1200 New Jersey Avenue SE., of town, the train derailed. The Transport Canada explained in the Washington, DC 20590, telephone (202) locomotives separated from the train emergency directive that the cause of 493–6404; Joseph St. Peter, Trial Attorney, Office of Chief Counsel, FRA, 1 This accident occurred in Canada and DOT is 2 Available online at: http://www.tc.gc.ca/eng/ 1200 New Jersey Avenue SE., neither responsible for determining, nor has mediaroom/backgrounders-safety-locomotives- jurisdiction to investigate, the cause of this 7292.html. Additionally, in response to this Washington, DC 20590, telephone (202) accident. Further, Canadian authorities have not yet accident, the Transportation Safety Board of Canada determined the cause of this accident. As such, issued Rail Safety Advisory Letter—09/13 regarding 7 See 49 CFR 173.115 for the definition of nothing in this safety advisory is intended to the securement of equipment and trains left Division 2.1 flammable gas, 173.120 for definition attribute a definitive cause to this accident or place unattended; available online at: http:// of Class 3 flammable liquid; and 173.50 for the responsibility for the incident on the acts or www.tsb.gc.ca/eng/medias-media/sur-safe/letter/ definition of the various classes of explosives. omissions of any specific person or entity. rail/2013/r13d0054/r13d0054-617-09-13.asp.

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the accident in Lac-Me´gantic remains Emergency RSAC Meeting regarding train attendance and unknown at this time. However, the The Railroad Safety Advisory securement procedures, but FRA would emergency directive stated that, ‘‘. . . in Committee (RSAC) is a group composed like to explore the issue further in light of the catastrophic results of the of railroad industry, labor, and conjunction with PHMSA. FRA also Lac-Me´gantic accident and in the governmental representatives. FRA intends to discuss the various criteria interest of ensuring the continued safety established the RSAC in 1996 to and evaluation processes railroads have and security of railway transportation, develop recommendations on new used, or intend to use, to formulate there is an immediate need to clarify the regulatory standards and other rail plans they may choose to adopt that regime respecting unattended safety program issues through a identify locations where it is safe and locomotives on main track and sidings collaborative process with all segments suitable to leave trains unattended and and the transportation of dangerous of the rail community. FRA consults secured on main track or sidings outside goods in tank cars using a one person with the RSAC regularly regarding the of yards or terminals. crew to address any threat to the safety development of its regulatory program, DOT’s Review of the Lac Me´gantic and security of railway operations.’’ As and also to advise the RSAC of emerging Accident’s Safety Implications such, Transport Canada exercised its issues and statutory requirements, and Canadian authorities investigating statutory emergency directive authority to discuss other identified needs. The to order railroad companies in Canada this accident have not yet identified the RSAC may consider a variety of accident’s cause. However, the known to comply with the above-listed approaches to address safety issues, requirements. In addition, Transport facts at this point raise apparent safety- including the use of industry standards, related implications in several areas in Canada also issued an accompanying which can complement and be order pursuant to paragraph 19(a)(1) of which DOT regulates in the United incorporated into FRA regulations. States. In developing this safety the Canadian Railway Safety Act In light of the Lac-Me´gantic railroad directing railroad companies in Canada advisory and in preparing to participate accident, FRA is scheduling an in the emergency RSAC meeting, DOT to formulate or revise certain railroad emergency meeting of the RSAC to operating rules, respecting the safety has considered particular existing discuss the accident. FRA will publish Federal railroad and hazardous and security of unattended locomotives, a Federal Register notice to announce uncontrolled movements, and crew size materials safety regulations, existing the date, time, and location of this industry practices, and relevant requirements. The order provides that meeting. At this emergency meeting rules should be based on an assessment accident and inspection data. As FRA intends to address the safety mentioned above, FRA has already of safety and security risks, and shall at requirements that were issued in a minimum: issued Emergency Order No. 28 to • Emergency Order No. 28, and the address securement-related safety Ensure that the cab(s) of unattended recommendations made in this safety controlling locomotives are secure issues. Another area of concern is advisory. FRA also plans to discuss the resultant dangers that occur when trains against unauthorized entry; safety implications and potential costs • Ensure that the reversers of transporting hazardous materials are and benefits of the requirements in unattended locomotives are removed involved in accidents, in addition to Transport Canada’s emergency and secured; broader concerns involving the • Prevent uncontrolled movements of directives discussed above, and safety- securement of unattended rolling railway equipment by addressing, at a related initiatives going forward, equipment. Transport Canada’s minimum: including possible new RSAC tasks to emergency directive and accompanying Æ The application of handbrakes implement such safety-related order also raised potential human factor based on factors including but not initiatives. issues regarding crew size for trains limited to: FRA requests that both freight and transporting hazardous materials. Æ passenger railroads be prepared to Tonnage, gradient, location and Transportation of Hazardous Materials fatigue of the operator; discuss the Transport Canada directive Æ The application of independent and requiring that two-person crews operate DOT is making two recommendations automatic brakes; and trains carrying hazardous materials on in this safety advisory that relate to the Æ The application of temporary or main track. FRA believes initiatives to requirements in PHMSA’s Hazardous permanent derails as a secondary line of require a minimum of two Materials Regulations (49 CFR Parts [defense] at high risk locations such as crewmembers for over-the-road trains 171–180; HMR). In addition to the two sidings used for storage or main track (including both passenger and freight recommendations, the discussion below used for crew change-off, or in high risk trains) could enhance safety. At the addresses the safety implications conditions including consideration of emergency RSAC meeting FRA expects regarding the transportation of the type of goods being transported and to discuss the formulation of a task petroleum crude oil, and hazardous environmental conditions, in order to statement regarding appropriate train materials generally, by rail. As prevent movement due to tampering or crew size for an RSAC working group to illustrated at Lac-Me´gantic, it is often accidental release of brakes from consider. FRA also requests that RSAC the hazardous materials being defective components; representatives be specifically prepared transported in a train that have the • Ensure the security of stationary to discuss two other requirements potential to cause the most harm. railway equipment transporting contained in Emergency Order No. 28. Nonetheless, the transportation of ‘‘dangerous goods’’ as this expression is First, FRA intends to discuss the hazardous materials by rail is extremely defined in section 2 of the appropriate types and quantities of safe, and the vast majority of hazardous Transportation of Dangerous Goods Act; hazardous materials that should materials shipped by rail each year and preclude trains transporting such arrive at their destinations safely and • Provide for minimum operating materials from being left unattended on without incident. In calendar year 2011, crew requirements considering main track and sidings. Emergency for example, out of the approximately technology, length of train, speeds, Order No. 28 currently specifies certain 2.2 million shipments of hazardous classification of dangerous goods being types and quantities of hazardous materials transported by rail, there were transported, and other risk factors. materials that trigger requirements only 20 accidents in which a hazardous

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material was released. In these railroad accident causes were allocated DOT has already taken steps to provide accidents, a total of 66 hazardous as follows: Human factors (35.7 for the safety of transportation of materials cars released some amount of percent); track and structures (34.5 hazardous materials by rail, and will product. DOT has developed and percent); equipment (12.7 percent); continue to evaluate the need for enforces a comprehensive regulatory signal and train control (2.4 percent); additional safety measures as details of framework for the safe rail and miscellaneous (14.7 percent). DOT the Lac-Me´gantic accident become transportation of hazardous materials. has taken a variety of actions to address known. This comprehensive regulatory program these accident causes, including the DOT’s HMR-related recommendations serves to mitigate the safety risk promulgation of FRA’s human factors below are in regard to the proper associated with the rail transportation of regulation on operational tests and classification of crude oil and the hazardous materials. However, as this inspections involving handling HMR’s requirements regarding railroad accident, and accidents such as the 2005 equipment, switches, and fixed derails, and hazardous materials offeror and Graniteville, South Carolina incident in passenger hours of service rules, carrier safety and security plans. First, which a single breached railroad tank regulations requiring the installation of the HMR require that an offeror 5 of a car containing chlorine resulted in nine positive train control systems on certain hazardous material properly classify fatalities indicate, both DOT and the rail lines, regulations governing the use of and describe the hazardous material. industry must remain vigilant and distracting electronic devices by See 49 CFR § 173.22. To attest continually seek to improve safety. railroad operating employees, compliance with the HMR, an offeror of The train involved in the Lac- regulations governing conductor a hazardous material must also certify Me´gantic accident was a unit train of certification, the issuance of a notice of that the hazardous material being tank cars containing petroleum crude proposed rulemaking on the training of offered into transportation is offered in oil. Industry statistics demonstrate that, certain railroad employees, the issuance compliance with the HMR. In the case in terms of rail originations, crude oil of a notice of proposed rulemaking of petroleum crude oil, relevant shipments are the fastest growing of all regarding railroad track inspection properties to properly classify the hazardous materials shipped by rail. practices, and the issuance of a notice material include: Flash point, According to the Association of of proposed rulemaking to require corrosivity, specific gravity at loading American Railroads’ (AAR) Annual system safety programs on certain and reference temperatures, and the Report of Hazardous Materials passenger railroads. presence and concentration of specific Transported by Rail for 2012, the As applicable to the rail compounds such as sulfur (as found in number of crude oil originations has transportation of hazardous materials, sour crude oil). The classification increased by 443% since 2005. Further, and particularly tank car requirements in the HMR ultimately since 2005, rail shipments of ethanol crashworthiness in instances when determine the appropriate and have increased by a similar percentage. accidents do occur, PHMSA has issued authorized selection of the packaging, DOT anticipates that for the foreseeable numerous regulations designed to the fill densities and outage, future rail shipment originations of improve the accident survivability of accompanying hazard communications crude oil will remain high.3 Both rail tank cars carrying hazardous (markings, labels and placards), ethanol and crude oil are classified as materials. Most recently, in 2009, transportation safety and operational Class 3 flammable or combustible PHMSA issued a final rule requiring controls, and safety and security liquids by the HMR. newly constructed tank cars designed to planning; and, if necessary, they enable The causes of rail accidents involving carry materials toxic-by-inhalation (TIH the most effective and informed trains carrying hazardous materials are materials or materials poisonous-by- emergency response. often related to railroad operational or inhalation (PIH materials)) to have Crude oil transported by rail often mechanical failures. For example, as increased side and head-impact derives from different sources and is based on FRA’s accident reporting data puncture resistance by requiring a then blended, so it is critical that for the period from 2008 through 2012, combination of thicker outer jackets offerors properly classify a hazardous and/or inner shells and the use of full material and select the proper HMR- 3 The U.S. Energy Information Administration head shields where not already authorized packaging for transportation anticipates that crude oil rail export capacity from mandated by regulation.4 The rule also of that hazardous material. Section the Bakken region, located mostly in North Dakota, establishes enhanced standards and 173.150(f) of the HMR allows flammable will increase over the next two years. See http:// features to protect the valves, top liquids such as petroleum crude oil with www.eia.gov/todayinenergy/detail.cfm?id=10431. ° ° Much of the near term growth in rail originations fittings and nozzles of newly a flash point at or above 38 C (100 F) is currently a function of how quickly tank car constructed TIH materials tank cars and that do not meet the definition of any manufacturers can produce new cars to meet the imposes a 50 mile-per-hour (‘‘mph’’) other hazard class to be reclassified as demand for tank cars, primarily for Bakken crude a combustible liquid, and excepts such oil. The rise in rail originations in crude oil is speed limit for all trains transporting subject to changes in the number of tank cars loaded tank cars containing TIH combustible liquids from certain HMR available, price of crude oil, and overall production materials. requirements, to include the of crude oil in that region, and is also dependent Further, PHMSA is currently requirement that the material be on whether, or how quickly, additional pipeline formulating an advanced notice of transported in a DOT-specification bulk export capacity from that region comes online. 6 However, for the foreseeable future, all indications proposed rulemaking addressing, among packaging. As such, AAR 211 class cars are for continued growth of rail originations of other items, safety improvements to are permitted, in certain instances, to be crude in that region as new tank car fleets come DOT Specification 111 tank cars, which used to transport crude oil that has been online to meet demand. Bakken crude oil is are commonly used to transport crude classified as a Packing Group III primarily shipped via rail to refineries located near the U.S. Gulf Coast or also to pipeline connections, oil and ethanol. DOT has also scheduled most notably to connections located in Oklahoma. a public meeting on August 27–28 to 5 See 49 CFR 171.8 for the definition of ‘‘person Crude oil is also shipped via rail to refineries on discuss improving the safety of the who offers’’ or ‘‘offeror.’’ the East Coast and, to a lesser extent, refineries in transportation of hazardous materials by 6 Section 172.102, Special Provision B1, states, ‘‘If other regions of the U.S. See Association of the material has a flash point at or above 38 °C American Railroads Moving Crude Oil by Rail (May rail. As the above discussion indicates, (100 °F) and below 93 °C (200 °F), then the bulk 2013), https://www.aar.org/keyissues/Documents/ packaging requirements of § 173.241 of this Back ground-Papers/Crude-oil-by-rail.pdf. 4 74 FR 1770 (Jan. 13, 2009). subchapter are applicable.’’

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material with a relatively high flash equipment is secured. FRA conducts securement and all human factor-related point. This distinction has safety inspections on a regular basis to monitor operating rules, are evaluated for implications if the crude oil being compliance with these applicable effectiveness. Operational testing should transported has been improperly railroad securement procedures that regularly take place under all operation classified and actually has a lower flash railroads adopt in accordance with conditions in which railroad employees point and is a Packing Group I or II FRA’s securement regulation. A review perform duties. DOT encourages flammable liquid material. As such, of FRA’s inspection data indicates that railroads to utilize all tools at their DOT recommends that offerors evaluate since 2010, FRA inspectors have disposal, to include checking their processes for testing, classifying, conducted 163,510 observations for locomotive downloads to monitor and packaging the crude oil that they compliance with railroad procedures compliance with railroad rules requiring offer into transportation via railroad adopted to comply with FRA’s certain actions be taken (e.g., air brake tank car as required by Part 173 of the securement requirements for both release) to verify that a sufficient HMR. The frequency and type of testing passenger and freight trains at § 232.103 number of handbrakes have been set to should be based on an offeror’s and at 49 CFR part 238. FRA inspectors prevent a train’s movement. FRA plans knowledge of the hazardous material, have discovered 5,236 instances where to place particular emphasis on its with specific consideration given to the these railroad securement procedures inspection efforts related to monitoring volume of hazardous material shipped, were not complied with, and railroad compliance with securement the variety of sources that the hazardous recommended violations in 1,625 of procedures. material is generated from, and the those instances. FRA’s Emergency Order Two additional recommendations processes that generate the hazardous No. 28 was based, in part, on the above below also relate to preventing the material. information, and requires railroads in unauthorized movement of trains. The With regard to DOT’s next HMR- the United States to adopt certain first of these recommendations relates to related recommendation, the HMR also additional securement procedures to removing the reverse lever (reverser), include requirements that specifically prevent accidents like the one that when the lever is capable of being address safety and security plans for the ´ occurred at Lac-Megantic when trains removed from the control stand by a transportation of certain hazardous make uncontrolled movements. train crewmember, from the controlling materials. Specifically, Subpart I part In addition to those requirements locomotive of any train left unattended 172 requires security plans to include conveyed in the emergency order, this on a main track outside of yard limits. an assessment of transportation security safety advisory makes additional train risks for shipments of hazardous securement-related recommendations. Emergency Order No. 28 addresses materials (e.g., a large bulk quantity of Existing Federal regulations, at 49 CFR requirements regarding the status of the Class 3 material such as crude oil part 217, require that railroads conduct reverser for trains transporting certain meeting the criteria for Packing Group I operational tests to ensure their hazardous materials that are left or II). See 49 CFR 172.800–802. This employees’ compliance with railroad unattended on mainline track or assessment at a minimum must include operating rules, and particularly those mainline sidings outside of a yard or elements addressing personnel security, rules which are most likely to cause the terminal. The recommendation in this unauthorized access, and en route most accidents or incidents. See 49 CFR safety advisory is meant to address any security. The plan must also include 217.9(c)(1). As the above statistics train or locomotive consist left security duties for each position or indicate, a failure to comply with unattended on main track outside of department that is responsible for railroads’ securement procedures yard or terminal, regardless of implementing the plan as well as the account for approximately 8.5% of commodity being transported. Railroads training of hazardous materials human factor caused accidents. When are currently required by 49 CFR employees. DOT is recommending that these accidents are viewed in light of 232.103(n)(4) to adopt procedures to offerors and carriers of hazardous the Lac-Me´gantic accident, it is clear govern the status of the reverse lever materials review their plans adopted in that compliance with Federal regulation (reverser) on unattended locomotives. accordance with subpart I of part 172 of and accompanying railroad procedures Typically, the rules adopted by railroads the HMR that govern the safety and governing the securement of unattended to comply with § 232.103(n)(4) require security of the transportation of railroad equipment is safety-critical. Thus, DOT that the reverser of an unattended tank cars containing hazardous is recommending that railroads evaluate locomotive be removed from the control materials. DOT recommends that after their current operational testing stand but do not require that the lever such review offerors and carriers of practices for securement-related rules otherwise be removed from a train or hazardous materials evaluate whether compliance, and determine whether secured. In an effort to ensure that any their existing plans adequately address their current testing practices are persons, primarily railroad trespassers, known or potential safety and security sufficient, both in quality and quantity are unable to easily initiate risks and, as necessary, amend the plans of the operational tests performed. unauthorized movements of any as to ensure the continued safe and In making this recommendation, FRA unattended trains outside of yard limits, secure transportation of railroad tank also notes that past audits of railroads’ DOT is recommending that railroads cars containing hazardous materials. operational testing records indicate, that amend their procedures adopted to in certain instances, there are significant comply with § 232.103(n)(4) to require Securement of Unattended Equipment discrepancies between the number of that when the reverser is removed from Next, with regard to the securement of operating rules compliance failures that the controlling locomotive of an unattended equipment, FRA accident railroads record when compared with unattended train that the lever is data indicates that approximately 8.5% the ratio of operating rule failures that actually removed from the cab or of human factor-caused accidents from FRA inspectors observe during otherwise secured in a place where a calendar year 2011 until April 2013 compliance inspections. DOT trespasser cannot readily access the were the result of improper securement. encourages railroads to use the lever. As the Lac-Me´gantic accident Existing Federal regulations, at 49 CFR recommendations in this safety advisory illustrates, the uncontrolled movement part 232, require that railroads adopt to ensure that their operational testing of a train can have catastrophic procedures to ensure that unattended practices, particularly as related to consequences. DOT will also evaluate

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whether future regulatory activities contains hazardous materials, an rail system, DOT recommends that should require railroad procedures be uncontrolled or unauthorized railroads: amended to enhance requirements movement of such train can have 1. Review with their employees the governing access to an unattended catastrophic consequences, especially circumstances of the Lac-Me´gantic train’s reverser lever. DOT looks on main track where passenger trains accident described in this Safety forward to discussing this issue and might also travel. Advisory. receiving information from the industry Human Factors 2. DOT believes that railroad safety is regarding this issue at the emergency enhanced through the use of multiple RSAC meeting. Finally, Transport Canada’s crew members. Accordingly, railroads The Transport Canada emergency emergency directive and order implicate should review their crew staffing directive also contained a provision other human factors issues such as crew practices for over-the-road trains that regarding the status of a train’s size, personnel available to secure transport: automatic and independent brakes trains, operator fatigue, and the possible when a train is left unattended on a use of derails as a secondary line of (a) Five or more tank car loads of any one defense against runaway trains at or any combination of materials poisonous by main track or siding for one hour or less. inhalation as defined in 49 CFR 171.8, and Existing § 232.103(n)(4) of FRA’s certain, higher risk, locations. DOT is including anhydrous ammonia (UN 1005) regulations requires that railroads adopt making two recommendations below and ammonia solutions (UN 3318); or and comply with procedures governing regarding these issues. First, DOT is (b) 20 rail car loads or intermodal portable the status of the independent and making a recommendation regarding tank loads of any one or any combination of automatic brake valves (in addition to railroad crew staffing practices. materials listed in (a) above, or, any Division the status of the reverser lever as Transport Canada’s directive contained 2.1 flammable gas, Class 3 flammable liquid discussed directly above) when a specific requirement that railroads in or combustible liquid, Class 1.1 or 1.2 Canada operate trains carrying loaded explosive, or hazardous substance listed in locomotives are left unattended. 8 Traditionally, such rules adopted to hazardous materials tank cars over main 49 CFR 173.31(f)(2). comply with § 232.104(n)(4) in the track and sidings with at least two crew After such review, DOT recommends United States already require that a members. DOT believes that railroad that railroads amend existing practices train’s independent and automatic safety is enhanced through the use of as necessary to ensure the safe brakes be applied when a train is left multiple crew members and movement of trains containing the unattended for any period of time. Thus, recommends below that railroads above-listed hazardous materials on DOT has chosen not to address that item review their crew staffing practices for main track and sidings. DOT intends to in this safety advisory, but plans to over-the-road train movements of trains explore with the RSAC the appropriate discuss this topic along with all of the transporting 20 or more tank car loads level of crew staffing for over-the-road items addressed by the Transport of Class 3 flammable or combustible train operations. Canada emergency directive and order liquids, as well as certain of the amount 3. Amend their procedures adopted to at the emergency RSAC meeting. and type of hazardous materials comply with 49 CFR 232.103(n)(4) by Next, DOT is also recommending that specified in AAR’s Circular No. OT–55– requiring that the reverser lever of the railroads evaluate risks at locations M, October 1, 2012 (Circular),7 and, as controlling locomotive of a train or where trains are regularly left necessary, amend those practices to locomotive consist be either removed unattended on main track outside of ensure safety. DOT intends to explore from the cab of the controlling yard limits, such as at crew change with the RSAC the appropriate level of locomotive or otherwise secured (when points. DOT recommends that after crew staffing for over-the-road train such reversers are capable of being identifying locations where increased operations. As mentioned above, at the removed by a train crewmember) to risks exist (for example, due to grade emergency RSAC meeting FRA expects prevent unauthorized movement of any conditions or trespasser accessibility to to ask the RSAC to consider the creation train or locomotive consist left unattended trains at particular of a task statement regarding unattended on mainline track or locations) railroads adopt procedures to appropriate crew size for both freight mainline siding outside of a yard or mitigate such risks that could result in and passenger operations for an RSAC terminal. unauthorized or uncontrolled train working group to consider. 4. Review both their operational movements. DOT understands that DOT is also recommending below that testing programs (as adopted in many railroads that transport hazardous railroads evaluate all of the other human accordance with 49 CFR 217.9) and materials by rail may have already factors raised by Transport Canada with relevant accident data related to the implemented certain portions of such an regard to train operations in the United securement of unattended equipment to evaluation in complying with 49 CFR States, particularly as related to train determine whether it is appropriate to 172.800–172.820 of the HMR, which as operations on main track, and amend increase the frequency of, or to discussed above govern planning those procedures as necessary. FRA otherwise enhance, operational tests requirements for the transportation of plans to address this recommendation, performed to determine the extent of hazardous materials. DOT also and, as discussed above, also plans to railroad employee compliance with recognizes that railroads may undertake address any other items at the operating rules governing the proper such evaluations if they choose to emergency RSAC meeting that are raised securement of unattended equipment. submit a plan to DOT regarding where in Transport Canada’s emergency DOT also recommends that railroads trains containing certain hazardous directive and order that are not ensure that their operational tests are materials may be left unattended, as otherwise addressed in Emergency conducted under all operational described in Emergency Order No. 28. Order No. 28 or this safety advisory. conditions, and that the results of such However, DOT recommends that such Recommended Railroad Actions: In operational tests are accurately reflected analysis/evaluation of how to mitigate light of the above discussion, and in an risks be undertaken specifically for effort to maintain safety of the Nation’s 8 See 49 CFR 173.115 for the definition of locations on main track where all trains Division 2.1 flammable gas, 173.120 for definition are regularly left unattended outside of 7 Available online at: http://boe.aar.com/CPC- of Class 3 flammable liquid; and 173.50 for the yard limits, as whether or not a train 1242_OT-55-M.pdf. definition of the various classes of explosives.

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in the records required to be kept by 49 Issued in Washington, DC, on August 2, with section 529 and to determine the CFR 217.9(d). 2013. taxable amount of a distribution. 5. Conduct system-wide evaluations Robert Lauby, Current Actions: There is no change to to identify particular hazards (e.g., Acting Associate Administrator for Railroad this existing regulation. Safety/Chief Safety Officer, Federal Railroad grade, train commodity, trespasser Administration. Type of review: Extension of OMB accessibility) which increase Magdy El-Sibaie, approval. securement and other safety risks at Associate Administrator for Hazardous Affected Public: State, local or tribal crew change locations and other Materials Safety, Pipeline and Hazardous governments and individuals or locations where any trains or rolling Materials Safety Administration. households. equipment are regularly left unattended. [FR Doc. 2013–19211 Filed 8–6–13; 8:45 am] Estimated Number of Respondents/ After identifying hazards at these BILLING CODE 4910–06–P locations, railroads should adopt Recordkeepers: 52. procedures to mitigate risks that could Estimated Time per Respondent/ result in unauthorized or uncontrolled DEPARTMENT OF THE TREASURY Recordkeeper: 81,889 hrs, 37 minutes. train movements. Estimated Total Annual Reporting/ 6. Review the other requirements in Internal Revenue Service Recordkeeping Burden Hours: Transport Canada’s emergency directive Proposed Collection; Comment 4,258,260. and order, to include human factor Request for Regulation Project The following paragraph applies to all requirements such as operator fatigue, of the collections of information covered the use of derails as a secondary line of AGENCY: Internal Revenue Service (IRS), by this notice: defense at high risk locations, and Treasury. An agency may not conduct or available personnel to secure a train, ACTION: Notice and request for and, as necessary, amend the comments. sponsor, and a person is not required to procedures governing these issues to respond to, a collection of information ensure the safety of train operations, SUMMARY: The Department of the unless the collection of information particularly as they relate to train Treasury, as part of its continuing effort displays a valid OMB control number. operations conducted on main track. to reduce paperwork and respondent Books or records relating to a collection burden, invites the general public and of information must be retained as long Recommended Hazardous Materials other Federal agencies to take this as their contents may become material Actions: In light of the above discussion, opportunity to comment on proposed in the administration of any internal and in an effort to maintain safety of the and/or continuing information revenue law. Generally, tax returns and Nation’s rail system, DOT recommends collections, as required by the tax return information are confidential, that: Paperwork Reduction Act of 1995, as required by 26 U.S.C. 6103. 1. Offerors evaluate their processes to Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is Request for Comments: Comments ensure that hazardous materials are submitted in response to this notice will properly classed and described in soliciting comments concerning Qualified State Tuition Programs. be summarized and/or included in the accordance with the HMR. request for OMB approval. All DATES: Written comments should be 2. Offerors and carriers of hazardous comments will become a matter of received on or before October 7, 2013 to materials review their safety and be assured of consideration. public record. Comments are invited on: security plans adopted in accordance (a) Whether the collection of ADDRESSES: Direct all written comments with subpart I of part 172 of the HMR. information is necessary for the proper to Yvette Lawrence, Internal Revenue Offerors and carriers evaluate whether performance of the functions of the Service, Room 6129, 1111 Constitution the existing plans adequately address agency, including whether the Avenue NW., Washington, DC 20224. personnel security, unauthorized access, information shall have practical utility; FOR FURTHER INFORMATION CONTACT: and en-route security and, as necessary, (b) the accuracy of the agency’s estimate Requests for additional information or amend the plans as to ensure the of the burden of the collection of copies of the regulations should be continued safe and secure information; (c) ways to enhance the directed to LaNita Van Dyke, at (202) transportation of railroad tank cars quality, utility, and clarity of the 622–3215, or at Internal Revenue containing hazardous materials. Service, Room 6511, 1111 Constitution information to be collected; (d) ways to DOT encourages railroad and Avenue NW., Washington, DC 20224, or minimize the burden of the collection of hazardous material industry members to through the internet, at information on respondents, including take actions that are consistent with the [email protected] through the use of automated collection preceding recommendations, and to take techniques or other forms of information SUPPLEMENTARY INFORMATION: other complementary actions to help technology; and (e) estimates of capital Title: Qualified State Tuition or start-up costs and costs of operation, ensure the safety of the Nation’s Programs. maintenance, and purchase of services railroads. DOT may modify this safety OMB Number: 1545–1614. to provide information. advisory, issue additional safety Regulation Project Number: REG– advisories, or take other appropriate 106177–97. Approved: July 11, 2013. actions necessary to ensure the highest Abstract: This regulation affects Allan Hopkins, level of safety on the Nation’s railroads, qualified tuition programs (QTPs) Tax Analyst. including pursuing other corrective described in Code section 529 and [FR Doc. 2013–19000 Filed 8–6–13; 8:45 am] measures under its rail and hazardous individuals receiving distributions from BILLING CODE 4830–01–P materials safety authority. the programs. Information will be used by the IRS and individuals receiving QTP distributions to verify compliance

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DEPARTMENT OF THE TREASURY Estimated Number of Respondents: ideas, and suggestions on improving 1,000. customer service at the Internal Revenue Internal Revenue Service Estimated Time Per Respondent: 1 Service. hour. DATES: The meeting will be held Proposed Collection; Comment Estimated Total Annual Burden Wednesday, September 11, 2013. Request for Regulation Project Hours: 1,000. FOR FURTHER INFORMATION CONTACT: The following paragraph applies to all AGENCY: Internal Revenue Service (IRS), Timothy Shepard at 1–888–912–1227 or of the collections of information covered Treasury. 206–220–6095. by this notice: ACTION: Notice and request for An agency may not conduct or SUPPLEMENTARY INFORMATION: Notice is comments. sponsor, and a person is not required to hereby given pursuant to Section respond to, a collection of information 10(a)(2) of the Federal Advisory SUMMARY: The Department of the Committee Act, 5 U.S.C. App. (1988) Treasury, as part of its continuing effort unless the collection of information displays a valid OMB control number. that a meeting of the Taxpayer to reduce paperwork and respondent Advocacy Panel Notices and burden, invites the general public and Books or records relating to a collection of information must be retained as long Correspondence Project Committee will other Federal agencies to take this be held Wednesday, September 11, opportunity to comment on proposed as their contents may become material in the administration of any internal 2013, at 12 p.m. Eastern Time via and/or continuing information teleconference. The public is invited to collections, as required by the revenue law. Generally, tax returns and tax return information are confidential, make oral comments or submit written Paperwork Reduction Act of 1995, statements for consideration. Due to Public Law 104–13 (44 U.S.C. as required by 26 U.S.C. 6103. Request for Comments: Comments limited conference lines, notification of 3506(c)(2)(A)). Currently, the IRS is submitted in response to this notice will intent to participate must be made with soliciting comments concerning an be summarized and/or included in the Timothy Shepard. For more information existing regulation, TD 9353, Section request for OMB approval. All please contact Mr. Shepard at 1–888– 1045 Application to Partnerships. comments will become a matter of 912–1227 or 206–220–6095, or write DATES: Written comments should be public record. Comments are invited on: TAP Office, 915 2nd Avenue MS W– received on or before October 7, 2013 to (a) Whether the collection of 406, Seattle, WA 98174, or contact us at be assured of consideration. information is necessary for the proper the Web site: http://www.improveirs.org. ADDRESSES: Direct all written comments performance of the functions of the The agenda will include a discussion to Yvette Lawrence, Internal Revenue agency, including whether the on various letters, and other issues Service, Room 6129, 1111 Constitution information shall have practical utility; related to written communications from Avenue NW., Washington, DC 20224. (b) the accuracy of the agency’s estimate the IRS. FOR FURTHER INFORMATION CONTACT: of the burden of the collection of July 31, 2013. Requests for additional information or information; (c) ways to enhance the Otis Simpson, copies of the regulations should be quality, utility, and clarity of the Acting Director, Taxpayer Advocacy Panel. directed to LaNita Van Dyke at Internal information to be collected; (d) ways to [FR Doc. 2013–19001 Filed 8–6–13; 8:45 am] Revenue Service, Room 6511, 1111 minimize the burden of the collection of BILLING CODE 4830–01–P Constitution Avenue NW., Washington, information on respondents, including DC 20224, or at (202) 622–3215, or through the use of automated collection through the Internet at techniques or other forms of information DEPARTMENT OF THE TREASURY [email protected]. technology; and (e) estimates of capital or start-up costs and costs of operation, Internal Revenue Service SUPPLEMENTARY INFORMATION: maintenance, and purchase of services Title: Section 1045 Application to to provide information. Open Meeting of the Taxpayer Partnerships. Advocacy Panel Taxpayer OMB Number: 1545–1893. Approved: July 11, 2013. Communications Project Committee Regulation Project Number: TD 9353. Allan Hopkins, Abstract: This document contains Tax Analyst. AGENCY: Internal Revenue Service (IRS) regulations relating to the application of [FR Doc. 2013–18999 Filed 8–6–13; 8:45 am] Treasury. section 1045 of the Internal Revenue BILLING CODE 4830–01–P ACTION: Notice of Meeting. Code (Code) to partnerships and their SUMMARY: partners. These regulations provide An open meeting of the rules regarding the deferral of gain on a DEPARTMENT OF THE TREASURY Taxpayer Advocacy Panel Taxpayer partnership’s sale of qualified small Communications Project Committee will business stock and deferral of gain on a Internal Revenue Service be conducted. The Taxpayer Advocacy partner’s sale of qualified small business Panel is soliciting public comments, stock distributed by a partnership. The Open Meeting of the Taxpayer ideas, and suggestions on improving final regulations affect partnerships that Advocacy Panel Notices and customer service at the Internal Revenue invest in qualified small business stock Correspondence Project Committee Service. DATES: The Meeting will be held and their partners. This document also AGENCY: Internal Revenue Service (IRS) provides notice of a public hearing on Treasury. Thursday, September 19, 2013. FOR FURTHER INFORMATION CONTACT: the proposed regulations. ACTION: Notice of Meeting. Current Actions: There is no change to Ellen Smiley or Patti Robb at 1–888– this existing regulation. SUMMARY: An open meeting of the 912–1227 or 414–231–2360. Type of Review: Extension of the Taxpayer Advocacy Panel Notices and SUPPLEMENTARY INFORMATION: Notice is currently approved collection. Correspondence Project Committee will hereby given pursuant to Section Affected Public: Individuals or be conducted. The Taxpayer Advocacy 10(a)(2) of the Federal Advisory households. Panel is soliciting public comments, Committee Act, 5 U.S.C. App. (1988)

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that an open meeting of the Taxpayer Stop 5115, Des Moines, IA 50309 or July 31, 2013. Advocacy Panel Taxpayer contact us at the Web site: http:// Otis Simpson, Communications Project Committee will www.improveirs.org. Acting Director, Taxpayer Advocacy Panel. be held Thursday, September 19, 2013, The agenda will include various [FR Doc. 2013–18996 Filed 8–6–13; 8:45 am] at 2:00 p.m. Eastern Time via committee issues for submission to the BILLING CODE 4830–01–P teleconference. The public is invited to IRS and other TAP related topics. Public make oral comments or submit written input is welcomed. statements for consideration. Due to DEPARTMENT OF THE TREASURY limited conference lines, notification of July 31, 2013. intent to participate must be made with Otis Simpson, Internal Revenue Service Ms. Ellen Smiley or Ms. Patti Robb. For Acting Director, Taxpayer Advocacy Panel. more information please contact Ms. [FR Doc. 2013–18997 Filed 8–6–13; 8:45 am] Open Meeting of the Taxpayer Smiley or Ms. Robb at 1–888–912–1227 BILLING CODE 4830–01–P Advocacy Panel Toll-Free Phone Line or 414–231–2360, or write TAP Office Project Committee. Stop 1006MIL, 211 West Wisconsin Avenue, Milwaukee, WI 53203–2221, or DEPARTMENT OF THE TREASURY AGENCY: Internal Revenue Service (IRS), post comments to the Web site: http:// Treasury. www.improveirs.org. Internal Revenue Service The committee will be discussing ACTION: Notice of Meeting. various issues related to Taxpayer Open Meeting of the Taxpayer Communications and public input is Advocacy Panel Tax Forms and SUMMARY: An open meeting of the welcome. Publications Project Committee Taxpayer Advocacy Panel Toll-Free July 31, 2013. Phone Line Project Committee will be Otis Simpson, AGENCY: Internal Revenue Service (IRS), conducted. The Taxpayer Advocacy Acting Director, Taxpayer Advocacy Panel. Treasury. Panel is soliciting public comments, [FR Doc. 2013–18998 Filed 8–6–13; 8:45 am] ACTION: Notice of Meeting. ideas, and suggestions on improving BILLING CODE 4830–01–P customer service at the Internal Revenue SUMMARY: An open meeting of the Service. Taxpayer Advocacy Panel Tax Forms DATES: The meeting will be held DEPARTMENT OF THE TREASURY and Publications Project Committee will Tuesday, September 17, 2013. be conducted. The Taxpayer Advocacy Internal Revenue Service Panel is soliciting public comments, FOR FURTHER INFORMATION CONTACT: Linda Rivera at 1–888–912–1227 or Open Meeting of the Taxpayer ideas and suggestions on improving (202) 622–8390. Advocacy Panel Joint Committee customer service at the Internal Revenue Service. SUPPLEMENTARY INFORMATION: Notice is AGENCY: Internal Revenue Service (IRS) hereby given pursuant to Section Treasury. DATES: The meeting will be held Wednesday, September 11, 2013. 10(a)(2) of the Federal Advisory ACTION: Notice of Meeting. Committee Act, 5 U.S.C. App. (1988) FOR FURTHER INFORMATION CONTACT: SUMMARY: An open meeting of the that an open meeting of the Taxpayer Marisa Knispel at 1–888–912–1227 or Advocacy Panel Toll-Free Phone Line Taxpayer Advocacy Panel Joint 718–834–2203. Committee will be conducted. The Project Committee will be held Tuesday, Taxpayer Advocacy Panel is soliciting SUPPLEMENTARY INFORMATION: Notice is September 17, 2013 at 11:00 a.m. public comments, ideas, and hereby given pursuant to section Eastern Time via teleconference. The suggestions on improving customer 10(a)(2) of the Federal Advisory public is invited to make oral comments service at the Internal Revenue Service. Committee Act, 5 U.S.C. App. (1988) or submit written statements for DATES: The meeting will be held that an open meeting of the Taxpayer consideration. Due to limited Wednesday, September 25, 2013. Advocacy Panel Tax Forms and conference lines, notification of intent FOR FURTHER INFORMATION CONTACT: Publications Project Committee will be to participate must be made with Linda Susan Gilbert at 1–888–912–1227 or held Wednesday, September 11, 2013 at Rivera. For more information please (515) 564–6638. 11:00 a.m. Eastern Time via contact: Ms. Rivera at 1–888–912–1227 teleconference. The public is invited to or (202) 622–8390, or write TAP Office, SUPPLEMENTARY INFORMATION: Notice is make oral comments or submit written 1111 Constitution Avenue NW., Room hereby given pursuant to Section statements for consideration. Due to 10(a)(2) of the Federal Advisory 1509- National Office, Washington, DC limited conference lines, notification of Committee Act, 5 U.S.C. App. (1988) 20224, or contact us at the Web site: that an open meeting of the Taxpayer intent to participate must be made with http://www.improveirs.org. Advocacy Panel Joint Committee will be Ms. Knispel. For more information The committee will be discussing held Wednesday, September 25, 2013 at please contact Ms. Knispel at 1–888– Toll-free issues and public input is 912–1227 or 718–834–2203, or write 2:00 p.m. Eastern Time via welcomed. teleconference. The public is invited to TAP Office, 2 Metro Tech Center, 100 July 31, 2013. make oral comments or submit written Myrtle Avenue 7th Floor, Brooklyn, NY statements for consideration. 11201, or contact us at the Web site: Otis Simpson, Notification of intent to participate must http://www.improveirs.org. Acting Director, Taxpayer Advocacy Panel. be made with Susan Gilbert. For more The committee will be discussing [FR Doc. 2013–18993 Filed 8–6–13; 8:45 am] information please contact Ms. Gilbert various issues related to Tax Forms and BILLING CODE 4830–01–P at 1–888–912–1227 or (515) 564–6638 or Publications and public input is write: TAP Office, 210 Walnut Street, welcomed.

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DEPARTMENT OF THE TREASURY suggestions on improving customer consideration. Due to limited service at the Internal Revenue Service. conference lines, notification of intent Internal Revenue Service DATES: The meeting will be held to participate must be made with Donna Tuesday, September 10, 2013. Powers. For more information please Open Meeting of the Taxpayer contact Ms. Donna Powers at 1–888– FOR FURTHER INFORMATION CONTACT: Advocacy Panel Taxpayer Assistance 912–1227 or (954) 423–7977, or write Donna Powers at 1–888–912–1227 or Center Improvements Project TAP Office, 1000 S. Pine Island Road, (954) 423–7977. Committee Plantation, FL 33324 or contact us at the SUPPLEMENTARY INFORMATION: Notice is Web site: http://www.improveirs.org. AGENCY: Internal Revenue Service (IRS) hereby given pursuant to Section Treasury. The committee will be discussing 10(a)(2) of the Federal Advisory various issues related to the Taxpayer ACTION: Notice of Meeting. Committee Act, 5 U.S.C. App. (1988) Assistance Centers and public input is that a meeting of the Taxpayer welcomed. SUMMARY: An open meeting of the Advocacy Panel Taxpayer Assistance Taxpayer Advocacy Panel Taxpayer Center Improvements Project Committee July 31, 2013. Assistance Center Improvements Project will be held Tuesday, September 10, Otis Simpson, Committee will be conducted. The 2013, at 2:00 p.m. Eastern Time. The Acting Director, Taxpayer Advocacy Panel. Taxpayer Advocacy Panel is soliciting public is invited to make oral comments [FR Doc. 2013–19002 Filed 8–6–13; 8:45 am] public comments, ideas, and or submit written statements for BILLING CODE 4830–01–P

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Part II

Department of Health and Human Services

Center for Medicare & Medicaid Services 42 CFR Part 418 Medicare Program; FY 2014 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements; and Updates on Payment Reform; Final Rule

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DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: 2. Quality Measures for Hospice Quality HUMAN SERVICES Wage Index Addenda: In the past, the Reporting Program and Data Submission wage index addenda referred to in the Requirements for Payment Year FY 2014 Centers for Medicare & Medicaid preamble of our proposed and final 3. Quality Measures for Hospice Quality Services Reporting Program and Data Submission rules were available in the Federal Requirements for Payment Year FY 2015 Register. However, the wage index and Beyond 42 CFR Part 418 addenda of the annual proposed and 4. Quality Measures for Hospice Quality [CMS–1449–F] final rules will no longer be available in Reporting Program for Payment Year FY the Federal Register. Instead, these 2016 and Beyond RIN 0938–AR64 addenda will be available only through 5. Public Availability of Data Submitted the internet on the CMS Web site at: 6. The CMS Hospice Experience of Care Medicare Program; FY 2014 Hospice (http://www.cms.gov/Medicare/ Survey for the FY 2017 Payment Wage Index and Payment Rate Update; Medicare-Fee-for-Service-Payment/ Determination and That of Subsequent Hospice Quality Reporting Fiscal Years Hospice/index.html.) Readers who 7. Notice Pertaining to Reconsiderations Requirements; and Updates on experience any problems accessing any Payment Reform Following APU Determinations of the wage index addenda related to the C. FY 2014 Hospice Wage Index and Rates AGENCY: Centers for Medicare & hospice payment rules that are posted Update Medicaid Services (CMS), HHS. on the CMS Web site identified above 1. Hospice Wage Index 2. FY 2014 Wage Index With an Additional ACTION: Final rule. should contact Anjana Patel at 410– 786–2120. 15 Percent Reduced Budget Neutrality Adjustment Factor (BNAF) SUMMARY: This final rule updates the Table of Contents 3. Hospice Payment Update Percentage hospice payment rates and the wage 4. Final FY 2014 Hospice Payment Rates index for fiscal year (FY) 2014, and I. Executive Summary D. Update on Hospice Payment Reform and continues the phase out of the wage A. Purpose Data Collection index budget neutrality adjustment B. Summary of the Major Provisions 1. Update on Reform Options C. Summary of Costs, Benefits, and factor (BNAF). Including the FY 2014 15 a. Rebasing the Routine Home Care (RHC) Transfers Rate percent BNAF reduction, the total 5 year II. Background b. Site of Service Adjustment for Hospice cumulative BNAF reduction in FY 2014 A. Hospice Care Patients in Nursing Facilities will be 70 percent. The BNAF phase-out B. History of the Medicare Hospice Benefit 2. Reform Research Findings C. Services Covered by the Medicare will continue with successive 15 3. Additional Data Collection Hospice Benefit percent reductions in FY 2015 and FY E. Technical and Clarifying Regulatory D. Medicare Payment for Hospice Care 2016. This final rule also clarifies how Text Change 1. Omnibus Budget Reconciliation Act of hospices are to report diagnoses on V. Collection of Information Requirements 1989 VI. Regulatory Impact Analysis hospice claims, and provides updates to 2. Balanced Budget Act of 1997 A. Statement of Need the public on hospice payment reform. 3. FY 1998 Hospice Wage Index Final Rule Additionally, this final rule changes the 4. FY 2010 Hospice Wage Index Final Rule B. Overall Impact requirements for the hospice quality 5. The Affordable Care Act 1. Introduction reporting program by discontinuing 6. FY 2012 Hospice Wage Index Final Rule 2. Detailed Economic Analysis 3. Cost Allocation of Quality Reporting currently reported measures and E. Trends in Medicare Hospice Utilization III. Summary of the Provisions of the 4. Alternatives Considered implementing a Hospice Item Set with C. Accounting Statement seven National Quality Forum (NFQ) Proposed Rule A. Diagnosis Reporting on Hospice Claims D. Conclusion endorsed measures beginning July 1, 1. ICD–9–CM Coding Guidelines 1. Regulatory Flexibility Act Analysis 2014, as proposed. Finally, this final 2. Use of Nonspecific, Symptom Diagnoses 2. Unfunded Mandates Reform Act rule will implement the hospice 3. Use of ‘‘Mental, Behavioral and Analysis Experience of Care Survey on January 1, Neurodevelopmental Disorders’’ ICD–9– VII. Federalism Analysis and Regulations 2015, as proposed. CM Codes Text DATES: Effective Date: These regulations 4. Guidance on Coding of Principal and Acronyms Other, Additional, and/or Co-Existing are effective on October 1, 2013. Diagnoses Because of the many terms to which FOR FURTHER INFORMATION CONTACT: 5. Transition to ICD–10–CM we refer by acronym in this final rule, Debra Dean-Whittaker, (410) 786–0848, B. Hospice Quality Reporting Program we are listing the acronyms used and for questions regarding the hospice C. FY 2014 Hospice Wage Index and Rates their corresponding meanings in experience of care survey. Update alphabetical order below: Robin Dowell, (410) 786–0060, for D. Update on Hospice Payment Reform and APU Annual Payment Update questions regarding quality reporting Data Collection E. Technical and Clarifying Regulatory BBA Balanced Budget Act of 1997 for hospices and collection of Text Change BLS Bureau of Labor Statistics information requirements. IV. Analysis and Responses to Public BMI Body Mass Index Hillary Loeffler, (410) 786–0456, for Comments BNAF Budget Neutrality Adjustment Factor general questions about hospice A. Diagnosis Reporting on Hospice Claims CAD Coronary Artery Disease payment. 1. ICD–9–CM Coding Guidelines CAHPS® Consumer Assessment of Katherine Lucas, (410) 786–7723 for 2. Use of Nonspecific, Symptom Diagnoses Healthcare Providers and Systems questions regarding payment reform. 3. Use of ‘‘Mental, Behavioral and CBSA Core-Based Statistical Area Anjana Patel, (410) 786–2120, for Neurodevelopmental Disorders’’ ICD–9– CCW Chronic Conditions Warehouse questions regarding the FY 2014 CM Codes CFR Code of Federal Regulations 4. Guidance on Coding of Principal and CHC Continuous Home Care hospice wage index and payment Other, Additional, and/or Co-Existing CMS Centers for Medicare & Medicaid rates. Diagnoses Services Kelly Vontran, (410) 786–0332, for 5. Transition to ICD–10–CM COPD Chronic Obstructive Pulmonary questions on diagnosis reporting on B. The Hospice Quality Reporting Program Disease hospice claims. 1. Background and Statutory Authority CoPs Conditions of Participation

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CR Change Request PRRB Provider Reimbursement Review hospice wage index with more current CVA Cerebrovascular Accident Board wage data, and the BNAF will be CY Calendar Year QAPI Quality Assessment and Performance reduced by an additional 15 percent for Improvement DME Durable Medical Equipment a total BNAF reduction of 70 percent as FEHC Family Evaluation of Hospice Care RFA Regulatory Flexibility Act FR Federal Register RHC Routine Home Care described in section IV.C.3. The August FY Fiscal Year SBA Small Business Administration 6, 2009 FY 2010 Hospice Wage Index GAO Government Accountability Office SNF Skilled Nursing Facility final rule (74 FR 39384) finalized a 10 GIP General Inpatient Care TEFRA Tax Equity and Fiscal percent reduced BNAF for FY 2010 as HCFA Healthcare Financing Administration Responsibility Act of 1982 TEP Technical Expert Panel the first year of a 7-year phase-out of the HHS Health and Human Services BNAF, to be followed by an additional HIS Hospice Item Set I. Executive Summary 15 percent per year reduction in the HQRP Hospice Quality Reporting Program BNAF in each of the next 6 years. The ICD–9–CM International Classification of A. Purpose total BNAF phase-out will be complete Diseases, Ninth Revision, Clinical This final rule updates the payment by FY 2016. This final rule also clarifies Modification rates for hospice providers for fiscal diagnosis reporting on hospice claims, ICD–10–CM International Classification of year (FY) 2014 as required under section Diseases, Tenth Revision, Clinical 1814 (i) of the Social Security Act (the especially regarding the use of non- Modification specific symptom diagnoses; provides IDG Interdisciplinary Group Act). The updates incorporate the use of updated hospital wage index data, the an update on hospice payment reform IPPS Inpatient Prospective Payment System and additional data collection IRC Inpatient Respite Care 5th year of the 7-year Budget Neutrality LCD Local Coverage Determination Adjustment Factor (BNAF) phase-out, requirements; and finalizes a technical LUPA Low Utilization Payment Amount and an update to the hospice payment regulations text change. Additionally, MAP Measure Applications Partnership rates by the hospice payment update this final rule changes the requirements MedPAC Medicare Payment Advisory percentage. Additionally, this final rule for the hospice quality reporting Commission clarifies diagnosis reporting on hospice program by discontinuing currently MFP Multi-factor Productivity claims, provides an update on hospice reported measures and implementing a MSA Metropolitan Statistical Area payment reform and additional data Hospice Item Set with seven National NEC Not Elsewhere Classified collection requirements, and makes Quality Forum (NQF) endorsed NF Long Term Care Nursing Facility NPI National Provider Identifier changes to the quality reporting measures beginning July 1, 2014, as NQF National Quality Forum requirements for hospice providers. proposed. Finally, this final rule will OACT Office of the Actuary B. Summary of the Major Provisions implement the hospice Experience of OIG Office of Inspector General Care Survey on January 1, 2015, as OMB Office of Management and Budget In this final rule we update the proposed. PEACE Prepare, Embrace, Attend, hospice payment rates for FY 2014 by Communicate, and Empower 1.7 percent as described in section C. Summary of Costs, Benefits, and PRA Paperwork Reduction Act IV.C.3. We also update the FY 2014 Transfers

Provision description Total

FY 2014 Hospice Payment Rate Update ...... The overall economic impact of this final rule is an estimated $160 million in increased payments to hospices. Costs for Hospices to Submit Data ...... The total cost to hospice providers, for submitting data to the Hospice Item Set starting in July 2014, is $14.3 million.

II. Background and to facilitate patient autonomy, prevention and relief of suffering by access to information, and choice’’ (42 means of early identification, A. Hospice Care CFR 418.3). Palliative care is at the core assessment and treatment of pain and Coping with a life-limiting illness can of hospice philosophy and care other issues. In addition, palliative care be an overwhelming experience, practices. The person beginning hospice in hospice includes coordinating care physically, emotionally and spiritually, care, or his or her representative, needs services, reducing unnecessary for both the person and his or her to understand that his or her illness is diagnostics or ineffective therapies, and family. Recognition that the care needs no longer responding to medical offering ongoing conversations with at end-of-life are different from other interventions to cure or slow the individuals and their families about health care needs is a foundation of the progression of disease and then must changes in the disease and shifts in the Medicare Hospice Benefit. Hospice is a choose to stop further curative attempts plan of care to meet the changing needs compassionate care philosophy and while palliative care continues and with disease progression as the practice for those who are terminally ill. intensifies, as needed, for continued individual approaches the end-of-life. It is a holistic approach to treatment that symptom management. As we stated in Medicare hospice care is palliative recognizes that the impending death of the June 5, 2008 Hospice Conditions of care for individuals with a prognosis of an individual warrants a change from Participation final rule (73 FR 32088), living 6 months or less if the terminal curative to palliative care. Palliative palliative care is an approach that illness runs its normal course. As care means ‘‘patient and family-centered ‘‘optimizes quality of life by generally accepted by the medical care that optimizes quality of life by anticipating, preventing, and treating community, the term ‘‘terminal illness’’ anticipating, preventing, and treating suffering.’’ The goal of palliative care in refers to an advanced and progressively suffering. Palliative care throughout the hospice is to improve the quality of life deteriorating illness, and the illness is continuum of illness involves of individuals and their families facing diagnosed as incurable. When an addressing physical, intellectual, the issues associated with life- individual is terminally ill, many health emotional, social, and spiritual needs threatening illness through the problems are brought on by underlying

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condition(s), as bodily systems are individual can remain at home. take into consideration the following interdependent. In the June 5, 2008 Continuous home care may be covered factors: the nature and condition Hospice Conditions of Participation on a continuous basis for as much as 24 causing admission (including the final rule (73 FR 32088), we stated ‘‘the hours a day, and these periods must be presence or lack of objective data and medical director must consider the predominantly nursing care per our subjective complaints); complications primary terminal condition, related regulations at § 418.204. A minimum of and risk factors that affect care diagnoses, current subjective and 8 hours of care must be furnished on a planning; functional status; imminence objective medical findings, current particular day to qualify for the of death; and severity of symptoms. The medication and treatment orders, and continuous home care rate Medicare Hospice Benefit requires the information about unrelated conditions (§ 418.302(e)(4)). hospice to cover all reasonable and when considering the initial B. History of the Medicare Hospice necessary palliative care related to the certification of the terminal illness.’’ As Benefit terminal prognosis and related referenced in our regulations at 42 CFR conditions, as described in the patient’s 418.22(b)(1), to be eligible for Medicare Before the creation of the Medicare plan of care. The December 16, 1983 hospice services, the beneficiary’s Hospice Benefit, hospice was originally Hospice final rule (48 FR 56008) attending physician (if any) and the run by volunteers who cared for the requires hospices to cover care for hospice medical director must certify dying. During the early development interventions to manage pain and that the individual is terminally ill, that stages of the Medicare Hospice Benefit, symptoms. Clinically, related conditions is, the individual’s prognosis is for a life hospice advocates, working with are any physical or mental conditions expectancy of 6 months or less if the legislators, were clear that they wanted that are related to or caused by either terminal illness runs its normal course a Medicare benefit available that the terminal illness or the medications as defined in section 1861(dd)(3)(A) of provided all-inclusive care for used to manage the terminal illness.2 the Act and our regulations at § 418.3. terminally-ill individuals, provided Additionally, the hospice Conditions of The certification of terminal illness pain relief and symptom management, Participation at § 418.56(b), hospice must include a brief narrative and offered the opportunity to die with must provide all services necessary for explanation of the clinical findings that dignity in the comfort of one’s home the palliation and management of the 1 supports a life expectancy of 6 months rather than in an institutional setting. terminal illness, related conditions and or less as part of the certification and As stated in the August 22, 1983 interventions to manage pain and recertification forms as stated in proposed rule entitled ‘‘Medicare symptoms. Therapy and interventions § 418.22(b)(3). Program; Hospice Care’’ (48 FR 38146), must be assessed and managed in terms ‘‘the hospice experience in the United The goal of hospice care is to make of providing palliation and comfort States has placed emphasis on home the hospice patient as physically and without undue symptom burden for the care. It offers physician services, emotionally comfortable as possible, hospice patient or family.3 For example, specialized nursing services, and other with minimal disruption to normal a hospice patient with lung cancer (the forms of care in the home to enable the activities, while remaining primarily in terminal illness) may receive inhalants terminally ill individual to remain at the home environment. Hospice care for shortness of breath (related to the home in the company of family and uses an interdisciplinary approach to terminal condition). The patient may friends as long as possible.’’ The deliver medical, nursing, social, also suffer from metastatic bone pain (a concept of a beneficiary ‘‘electing’’ the psychological, emotional, and spiritual related condition) and would be treated hospice benefit and being certified as services through the use of a broad with opioid analgesics. As a result of the terminally ill were two key components spectrum of professional and other opioid therapy, the patient may suffer in the legislation responsible for the caregivers and volunteers. While the from constipation (an associated creation of the Medicare Hospice goal of hospice care is to allow for the symptom) and require a laxative for Benefit (section 122 of the Tax Equity individual to remain in his or her home symptom relief. It is often not a single and Fiscal Responsibility Act of 1982 environment, circumstances during the diagnosis that represents the terminal (TEFRA), (Pub. L. 97–248)). Section 122 end-of-life may necessitate short-term prognosis of the patient, but the of TEFRA created the Medicare Hospice inpatient admission to a hospital, combined effect of several conditions Benefit, which was implemented on skilled nursing facility (SNF), or hospice that makes the patient’s condition November 1, 1983. Under section facility for procedures necessary for terminal. We are restating what we 1861(dd) of the Social Security Act (the pain control or acute or chronic communicated in the December 16, Act), codified at 42 U.S.C. 1395x(dd), symptom management that cannot be 1983 Hospice final rule (48 FR 56010), we provide coverage of hospice care for managed in any other setting. These regarding what is related versus terminally ill Medicare beneficiaries acute hospice care services are to ensure unrelated to the terminal illness: ‘‘. . . who elected to receive care from a that any new or worsening symptoms we believe that the unique physical Medicare-certified hospice. Our are intensively addressed so that the condition of each terminally ill regulations at § 418.54(c) stipulate that individual can return to his or her home individual makes it necessary for these the comprehensive hospice assessment environment under routine hospice decisions to be made on a case-by-case must identify the patient’s physical, care. Short-term, intermittent, inpatient basis. It is our general view that psychosocial, emotional, and spiritual respite services are also available to the hospices are required to provide needs related to the terminal illness and family of the hospice patient when virtually all the care that is needed by related conditions, and address those needed to relieve the family or other terminally ill patients.’’ Therefore, needs in order to promote the hospice caregivers. Additionally, an individual unless there is clear evidence that a patient’s well-being, comfort, and can receive continuous home care dignity throughout the dying process. during a period of crisis in which an 2 Harder, PharmD, CGP, Julia. (2012). To Cover or The comprehensive assessment must individual requires primarily Not To Cover: Guidelines for Covered Medications in Hospice Patients. The Clinician. 7(2), p. 1–3. continuous nursing care to achieve 1 Connor, Stephen (2007). Development of 3 Paolini, DO, Charlotte. (2001). Symptoms palliation or management of acute Hospice and Palliative Care in the United States. Management at End of Life. JAOA. 101(10). p. 609– medical symptoms so that the OMEGA. 561(1), p. 89–99. 615.

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condition is unrelated to the terminal facility; continuous home care during intended to diminish the voluntary prognosis, all services would be periods of crisis and only as necessary spirit of hospices’’. considered related. It is also the to maintain the terminally ill individual D. Medicare Payment for Hospice Care responsibility of the hospice physician at home; and any other item or service to document why a patient’s medical which is specified in the plan of care Sections 1812(d), 1813(a)(4), needs would be unrelated to the and for which payment may otherwise 1814(a)(7), 1814(i), and 1861(dd) of the terminal prognosis. be made under Medicare, in accordance Act, and our regulations in part 418, The fundamental premise upon which with Title XVIII of the Act. establish eligibility requirements, the hospice benefit was designed was Section 1814(a)(7)(B) of the Act payment standards and procedures, the ‘‘revocation’’ of traditional curative requires that a written plan for define covered services, and delineate care and the ‘‘election’’ of hospice care providing hospice care to a beneficiary the conditions a hospice must meet to for end-of-life symptom management who is a hospice patient be established be approved for participation in the and maximization of quality of life, as before care is provided by, or under Medicare program. Part 418, subpart G, stated in the December 16,1983 Hospice arrangements made by, that hospice provides for a per diem payment in one final rule (48 FR 56008). After electing program and that the written plan be of four prospectively-determined rate hospice care, the patient typically periodically reviewed by the categories of hospice care (routine home returns to the home from an beneficiary’s attending physician (if care, continuous home care, inpatient institutionalized setting or remains in any), the hospice medical director, and respite care, and general inpatient care), the home, to be surrounded by family an interdisciplinary group (described in based on each day a qualified Medicare and friends, and to prepare emotionally section 1861(dd)(2)(B) of the Act). beneficiary is under hospice care (once and spiritually for death while receiving The services offered under the the individual has elected it). This per expert symptom management and other hospice benefit must be available, as diem payment is to include all of the supportive services. Election of hospice needed, to beneficiaries 24 hours a day, hospice services needed to manage the care also includes waiving the right to 7 days a week (section 1861(dd)(2)(A)(i) beneficiaries’ care, as required by Medicare payment for curative of the Act). Upon the implementation of section 1861(dd)(1) of the Act. There treatment for the terminal prognosis, the hospice benefit, the Congress has been little change in the hospice and instead receiving palliative care to expected hospices to continue to use payment structure since the benefit’s manage pain or symptoms. volunteer services, though these inception. The per diem rate based on The benefit was originally designed to services are not to be reimbursed (see level of care was established in 1983, cover hospice care for a finite period of Section 1861(dd)(2)(E) of the Act and 48 and this payment structure remains time that roughly corresponded to a life FR 38149). The hospice today with some adjustments, as noted expectancy of 6 months or less. Initially, interdisciplinary group should be below: beneficiaries could receive three comprised of paid hospice employees as 1. Omnibus Budget Reconciliation Act election periods: Two 90-day periods well as hospice volunteers, as stated in of 1989 and one 30-day period. Currently, the August 22, 1983 Hospice proposed Medicare beneficiaries can elect hospice rule (48 FR 38149). This expectation is Section 6005(a) of the Omnibus care for two 90-day periods and an in line with the history of hospice and Budget Reconciliation Act of 1989 (Pub. unlimited number of subsequent 60-day philosophy of holistic, comprehensive, L 101–239) amended section periods; however, the expectation compassionate, end-of-life care. 1814(i)(1)(C) of the Act and provided for remains that beneficiaries have a life The National Hospice Study was the following two changes in the expectancy of 6 months or less if the initiated in 1980 through a grant methodology concerning updating the terminal illness runs its normal course. sponsored by the Robert Wood Johnson daily payment rates: (1) Effective January 1, 1990, the daily payment rates C. Services Covered by the Medicare and John A. Hartford Foundations and for routine home care and other services Hospice Benefit CMS (formerly, the Health Care Financing Administration (HCFA)). The in included in hospice care were One requirement for coverage under study was conducted between October increased to equal 120 percent of the the Medicare Hospice Benefit is that 1980 and March 1983. The study rates in effect on September 30, 1989; hospice services must be reasonable and summarized the hospice care and (2) the daily payment rate for necessary for the palliation and routine home care and other services management of the terminal illness and philosophy as the following: • Patient and family know of the included in hospice care for fiscal years related conditions. Section 1861(dd)(1) terminal condition. beginning on or after October 1, 1990, of the Act establishes the services that • Further medical treatment and were the payment rates in effect during are to be rendered by a Medicare intervention are indicated only on a the previous Federal fiscal year certified hospice program. These supportive basis. increased by the hospital market basket covered services include: Nursing care; • Pain control should be available to percentage increase. physical therapy; occupational therapy; patients as needed to prevent rather 2. Balanced Budget Act of 1997 speech-language pathology therapy; than to just ameliorate pain. medical social services; home health • Interdisciplinary teamwork is Section 4441(a) of the Balanced aide services (now called hospice aide essential in caring for patient and Budget Act of 1997 (BBA) (Pub. L 105– services); physician services; family. 33) amended section 1814(i)(1)(C)(ii)(VI) homemaker services; medical supplies • Family members and friends should of the Act to establish updates to (including drugs and biologics); medical be active in providing support during hospice rates for FYs 1998 through appliances; counseling services the death and bereavement process. 2002. Hospice rates were updated by a (including dietary counseling); short- • Trained volunteers should provide factor equal to the hospital market term inpatient care (including both additional support as needed. basket percentage increase, minus 1 respite care and procedures necessary In the August 22, 1983 Hospice percentage point. Payment rates for FYs for pain control and acute or chronic proposed rule (48 FR 38149), we stated from 2002 have been updated according symptom management) in a hospital, ‘‘the hospice benefit and the resulting to section 1814(i)(1)(C)(ii)(VII) of the nursing facility, or hospice inpatient Medicare reimbursement is not Act, which states that the update to the

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payment rates for subsequent FYs will an additional 15 percent reduction for a Further, section 1814(i)(6) of the Act, be the hospital market basket percentage total reduction of 85 percent in FY 2015, as amended by section 3132(a)(1)(B) of increase for the FY. The Social Security and an additional 15 percent reduction the Affordable Care Act, authorizes the Act requires us to use the inpatient for complete elimination in FY 2016. Secretary to collect additional data and hospital market basket to determine We note that the BNAF is an information determined appropriate to hospice payment rates. adjustment, which increases the hospice revise payments for hospice care and wage index value. Therefore, the BNAF other purposes. The types of data and 3. FY 1998 Hospice Wage Index Final reduction is a reduction in the amount information suggested in the Affordable Rule of the BNAF increase applied to the Care Act would capture accurate In the August 8, 1997 FY 1998 hospice wage index value. It is not a resource utilization, which could be Hospice Wage Index final rule (62 FR reduction in the hospice wage index collected on claims, cost reports, and 42860), we implemented a new value, or in the hospice payment rates. possibly other mechanisms, as the methodology for calculating the hospice Secretary determines to be appropriate. 5. The Affordable Care Act wage index based on the The data collected may be used to revise recommendations of a negotiated Starting with FY 2013 (and in the methodology for determining the rulemaking committee. The original subsequent FYs), the market basket payment rates for routine home care and hospice wage index was based on 1981 percentage update under the hospice other services included in hospice care, Bureau of Labor Statistics hospital data payment system referenced in sections no earlier than October 1, 2013, as and had not been updated since 1983. 1814(i)(1)(C)(ii)(VII) and described in section 1814(i)(6)(D) of the In 1994, because of disparity in wages 1814(i)(1)(C)(iii) of the Act will be Act. In addition, we are required to from one geographical location to annually reduced by changes in consult with hospice programs and the another, the Hospice Wage Index economy-wide productivity, as Medicare Payment Advisory Negotiated Rulemaking Committee was specified in section 1886(b)(3)(B)(xi)(II) Commission (MedPAC) regarding formed to negotiate a new wage index of the Act, as amended by section additional data collection and payment methodology that could be accepted by 3132(a) of the Patient Protection and revision options. the industry and the government. This Affordable Care Act of 2010 (Pub. L. Committee was comprised of 111–148) as amended by the Health 6. FY 2012 Hospice Wage Index Final representatives from national hospice Care and Education Reconciliation Act Rule associations; rural, urban, large and of 2010 (Pub. L. 111–152) (the When the Medicare Hospice Benefit small hospices, and multi-site hospices; Affordable Care Act)). In FY 2013 was implemented, the Congress consumer groups; and a government through FY 2019, the market basket included an aggregate cap on hospice representative. The Committee decided percentage update under the hospice payments, which limits the total that in updating the hospice wage payment system will be reduced by an aggregate payments any individual index, aggregate Medicare payments to additional 0.3 percentage point hospice provider can receive in a year. hospices would remain budget neutral (although for FY 2014 to FY 2019, the The Congress stipulated that a ‘‘cap to payments calculated using the 1983 potential 0.3 percentage point reduction amount’’ be computed each year. The wage index, to cushion the impact of is subject to suspension under cap amount was set at $6,500 per using a new wage index methodology. conditions as specified in section beneficiary when first enacted in 1983 To implement this policy, a BNAF 1814(i)(1)(C)(v) of the Act). and is adjusted annually by the change would be computed and applied In addition, sections 1814(i)(5)(A) in the medical care expenditure annually to the pre-floor, pre- through (C) of the Act, as amended by category of the consumer price index for reclassified hospital wage index when section 3132(a) of the Affordable Care urban consumers from March 1984 to deriving the hospice wage index, subject Act, require hospices to begin March of the cap year (section to a wage index floor. submitting quality data, based on 1814(i)(2)(B) of the Act). The cap year is measures to be specified by the defined as the period from November 4. FY 2010 Hospice Wage Index Final Secretary, for FY 2014 and subsequent 1st to October 31st. As we stated in the Rule fiscal years. Beginning in FY 2014, August 4, 2011 FY 2012 Hospice Wage Inpatient hospital pre-floor and pre- hospices which fail to report quality Index final rule (76 FR 47308 through reclassified wage index values, as data will have their market basket 47314), for the 2012 cap year and described in the August 8, 1997 Hospice update reduced by 2 percentage points. subsequent cap years, the hospice Wage Index final rule are subject to Section 1814(a)(7)(D)(i) of the Act was aggregate cap will be calculated using either a budget neutrality adjustment or amended by section 3132 (b)(2)(D)(i) of the patient-by-patient proportional application of the wage index floor. the Affordable Care Act, and requires, methodology, within certain limits. We Wage index values of 0.8 or greater are effective January 1, 2011, that a hospice will allow existing hospices the option adjusted by the budget neutrality physician or nurse practitioner have a of having their cap calculated via the adjustment factor (BNAF). Starting in face-to-face encounter with an original streamlined methodology, also FY 2010, a 7-year phase-out of the individual to determine continued within certain limits. New hospices will BNAF began (August 6, 2009 FY 2010 eligibility of the individual for hospice have their cap determinations Hospice Wage Index final rule (74 FR care prior to the 180th-day calculated using the patient-by-patient 39384), with a 10 percent reduction in recertification and each subsequent proportional methodology. The patient- FY 2010, and additional 15 percent recertification and attest that such visit by-patient proportional methodology reduction for a total of 25 percent in FY took place. When implementing this and the streamlined methodology are 2011, an additional 15 percent provision, we decided that the 180th- two different methodologies for reduction for a total 40 percent in FY day recertification and subsequent counting beneficiaries when calculating 2012, and an additional 15 percent recertifications corresponded to the the hospice aggregate cap. A detailed reduction for a total of 55 percent in FY recertification for a beneficiary’s third or explanation of these methods is found 2013. The phase-out will continue with subsequent benefit periods (August 4, in the August 4, 2011 FY 2012 Hospice an additional 15 percent reduction for a 2011 FY 2012 Hospice Wage Index final Wage Index final rule (76 FR 47308 total reduction of 70 percent in FY 2014, rule (76 FR 47314)). through 47314). If a hospice’s total

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Medicare reimbursement for the cap the Actuary (OACT) projects that Medicare hospice enrollees, with a year exceeded the hospice aggregate hospice expenditures are expected to growing percentage of beneficiaries with cap, then the hospice would have to continue to increase by approximately 8 non-cancer diagnoses. Specifically, repay the excess back to Medicare. percent annually, reflecting an increase there were notable increases between E. Trends in Medicare Hospice in the number of Medicare beneficiaries, 2002 and 2007 in neurologically-based Utilization more beneficiary awareness of the diagnoses, including various dementia Medicare Hospice Benefit for end-of-life diagnoses. Additionally, there have Since the implementation of the care, and a growing preference for care been significant increases in the use of hospice benefit in 1983, and especially provided in home and community- within the last decade, there has been non-specific, symptom-classified based settings. However, this increased substantial growth in hospice diagnoses, such as ‘‘debility’’ and ‘‘adult utilization. The number of Medicare spending is partly due to an increased failure to thrive.’’ In FY 2012, both beneficiaries receiving hospice services average lifetime length of stay for ‘‘debility’’ and ‘‘adult failure to thrive’’ has grown from 513,000 in FY 2000 to beneficiaries, from 54 days in 2000 to 86 were in the top five claims-reported over 1.3 million in FY 2012. Similarly, days in FY 2010, an increase of 59 hospice diagnoses and were the first and Medicare hospice expenditures have percent. third most common hospice diagnoses, risen from $2.9 billion in FY 2000 to There have also been noted changes respectively (see Table 2 below). $14.7 billion in FY 2012. Our Office of in the diagnosis patterns among

TABLE 2—THE TOP TWENTY PRINCIPAL HOSPICE DIAGNOSES, FY 2002, FY 2007, FY 2012

Rank ICD–9/Reported principal diagnosis Total patients Percentage

Year: 2002 Total Patients = 663,406

1 ...... 162.9 Lung Cancer ...... 73,769 11 2 ...... 428.0 Congestive Heart Failure ...... 45,951 7 3 ...... 799.3 Debility Unspecified ...... 36,999 6 4 ...... 496 COPD ...... 35,197 5 5 ...... 331.0 Alzheimer’s Disease ...... 28,787 4 6 ...... 436 CVA/Stroke ...... 26,897 4 7 ...... 185 Prostate Cancer ...... 20,262 3 8 ...... 783.7 Adult Failure To Thrive ...... 18,304 3 9 ...... 174.9 Breast Cancer ...... 17,812 3 10 ...... 290.0 Senile Dementia, Uncomp...... 16,999 3 11 ...... 153.0 Colon Cancer ...... 16,379 2 12 ...... 157.9 Pancreatic Cancer ...... 15,427 2 13 ...... 294.8 Organic Brain Synd Nec ...... 10,394 2 14 ...... 429.9 Heart Disease Unspecified ...... 10,332 2 15 ...... 154.0 Rectosigmoid Colon Cancer ...... 8,956 1 16 ...... 332.0 Parkinson’s Disease ...... 8,865 1 17 ...... 586 Renal Failure Unspecified ...... 8,764 1 18 ...... 585 Chronic Renal Failure (End 2005) ...... 8,599 1 19 ...... 183.0 Ovarian Cancer ...... 7,432 1 20 ...... 188.9 Bladder Cancer ...... 6,916 1

Year: 2007 Total Patients = 1,039,099

1 ...... 799.3 Debility Unspecified ...... 90,150 9 2 ...... 162.9 Lung Cancer ...... 86,954 8 3 ...... 428.0 Congestive Heart Failure ...... 77,836 7 4 ...... 496 COPD ...... 60,815 6 5 ...... 783.7 Adult Failure To Thrive ...... 58,303 6 6 ...... 331.0 Alzheimer’s Disease ...... 58,200 6 7 ...... 290.0 Senile Dementia Uncomp...... 37,667 4 8 ...... 436 CVA/Stroke ...... 31,800 3 9 ...... 429.9 Heart Disease Unspecified ...... 22,170 2 10 ...... 185 Prostate Cancer ...... 22,086 2 11 ...... 174.9 Breast Cancer ...... 20,378 2 12 ...... 157.9 Pancreas Unspecified ...... 19,082 2 13 ...... 153.9 Colon Cancer ...... 19,080 2 14 ...... 294.8 Organic Brain Syndrome NEC ...... 17,697 2 15 ...... 332.0 Parkinson’s Disease ...... 16,524 2 16 ...... 294.10 Dementia In Other Diseases w/o Behav. Dist...... 15,777 2 17 ...... 586 Renal Failure Unspecified ...... 12,188 1 18 ...... 585.6 End Stage Renal Disease ...... 11,196 1 19 ...... 188.9 Bladder Cancer ...... 8,806 1 20 ...... 183.0 Ovarian Cancer ...... 8,434 1

Year: 2012 Total Patients = 1,328,651

1 ...... 799.3 Debility Unspecified ...... 161,163 12 2 ...... 162.9 Lung Cancer ...... 89,636 7 3 ...... 783.7 Adult Failure To Thrive ...... 86,467 7 4 ...... 428.0 Congestive Heart Failure ...... 84,333 6

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TABLE 2—THE TOP TWENTY PRINCIPAL HOSPICE DIAGNOSES, FY 2002, FY 2007, FY 2012—Continued

Rank ICD–9/Reported principal diagnosis Total patients Percentage

5 ...... 496 COPD ...... 74,786 6 6 ...... 331.0 Alzheimer’s Disease ...... 64,199 5 7 ...... 290.0 Senile Dementia, Uncomp...... 56,234 4 8 ...... 429.9 Heart Disease Unspecified ...... 32,081 2 9 ...... 436 CVA/Stroke ...... 31,987 2 10 ...... 294.10 Dementia In Other Diseases w/o Behavioral Dist...... 27,417 2 11 ...... 174.9 Breast Cancer ...... 22,421 2 12 ...... 153.9 Colon Cancer ...... 22,197 2 13 ...... 157.9 Pancreatic Cancer ...... 22,007 2 14 ...... 332.0 Parkinson’s Disease ...... 21,183 2 15 ...... 185 Prostate Cancer ...... 21,042 2 16 ...... 294.8 Other Persistent Mental Dis.-classified elsewhere ...... 17,762 1 17 ...... 585. 6 End Stage Renal Disease ...... 17,545 1 18 ...... 518.81 Respiratory Failure ...... 12,962 1 19 ...... 294.11 Dementia In Other Diseases w/Behavioral Dist...... 11,751 1 20 ...... 188.9 Bladder Cancer ...... 10,511 1 Source: FY 2002, 2007, and 2012 hospice claims data from the Chronic Conditions Warehouse (CCW), accessed on February 14 and Feb- ruary 20, 2013. Note(s): The frequencies shown represent beneficiaries that had a least one claim with the specific ICD–9 code reported as the principal diagnosis. Beneficiaries could be represented multiple times in the results if they have multiple claims during that time period with different principal diagnoses.

III. Summary of the Provisions of the Hospice Wage Index notice (77 FR physician(s) as the diagnosis most Proposed Rule 44247 through 44248) that all providers contributory to the terminal decline. The May 10, 2013 FY 2014 hospice are required to code and report the 3. Use of ‘‘Mental, Behavioral and proposed rule (78 FR 27823) included principal diagnosis as well as all Neurodevelopmental Disorders’’ ICD–9– the following clarifications, proposals, coexisting and additional diagnoses CM Codes related to the terminal condition or and updates: The proposed rule also clarified the • Diagnosis reporting on claims; related conditions to more fully describe • Proposed update to the Hospice the Medicare patients they are treating. ICD–9–CM Coding Guidelines for certain dementia codes that are reported Quality Reporting Program; 2. Use of Nonspecific Symptom • FY 2014 Rate Update; on hospice claims. There are several, • Update on Hospice Payment Reform Diagnoses but not all, codes that fall under the and Data Collection; and classification, ‘‘Mental, Behavioral and • The proposed rule included Neurodevelopmental Disorders,’’ that Technical and Clarifying additional diagnosis clarifications to Regulations Text Change. encompass multiple dementia diagnoses address current and ongoing diagnosis that are frequently reported principal A. Diagnosis Reporting on Claims reporting patterns noted on hospice hospice diagnoses on hospice claims, The FY 2014 Hospice Wage Index and claims, more specifically the use of but are not appropriate principal Payment Rate Update proposed rule nonspecific, symptom diagnoses and diagnoses per ICD–9–CM Coding clarified appropriate diagnosis reporting certain dementia diagnoses. In the Guidelines. proposed rule, we clarified that the on hospice claims. No proposals were 4. Guidance on Coding of Principal and made regarding diagnosis coding. These ICD–9–CM codes of ‘‘debility’’ and ‘‘adult failure to thrive’’ listed in the Other, Additional, and/or Co-Existing clarifications are not to preclude any Diagnoses clinical judgment in determining a ICD–9–CM Coding Guidelines under the beneficiary’s eligibility for hospice classification, ‘‘Symptoms, Signs, and In the proposed rule, we reiterated services. Eligibility for hospice services Ill-defined Conditions’’, are not to be that diagnosis reporting on the hospice is based on meeting the eligibility used as principal diagnoses when a claims should include the appropriate requirements as stated in § 418.20 of our related definitive diagnosis has been selection of principal diagnoses as well regulations: ‘‘an individual must be— established or confirmed by the as the other, additional and coexisting (a) Entitled to Part A of Medicare; and provider. Therefore, in the proposed diagnoses related to the terminal illness. (b) Certified as being terminally ill in rule, we clarified that ‘‘debility’’ and In the July 27, 2012 FY 2013 Hospice accordance with § 418.22.’’ ‘‘adult failure to thrive’’ should not be Wage Index notice (77 FR 44247), we used as principal hospice diagnoses on provided in-depth information 1. ICD–9–CM Coding Guidelines the hospice claim form. When reported regarding longstanding, existing ICD–9– The hospice benefit covers all care for as a principal diagnosis, these would be CM Coding Guidelines. We also the terminal illness, related conditions, considered questionable encounters for discussed related versus unrelated and for the management of pain and hospice care, and the claim would be diagnosis reporting on claims and symptoms. HIPAA, federal regulations, returned to the provider for a more clarified that ‘‘all of a patient’s and the Medicare hospice claims definitive principal diagnosis. coexisting or additional diagnoses’’ processing manual all require that ICD– ‘‘Debility’’ and ‘‘adult failure to thrive’’ related to the terminal illness or related 9–CM Coding Guidelines be applied to could be reported on the hospice claim conditions should be reported on the the coding and reporting of diagnoses as other, additional, or coexisting hospice claim. Based on analysis of on hospice claims. Regarding diagnosis diagnoses. The principal diagnosis preliminary claims data from the first reporting on hospice claims, we reported should be the condition quarter of FY 2013 (October 1, 2012 clarified in our July 27, 2012 FY 2013 determined by the certifying hospice through December 31, 2012), 72 percent

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of providers still only report one • We proposed to implement the rate; adjusting for current costs would diagnosis on the hospice claim. This Hospice Item Set (HIS), a standardized reduce the FY 2014 RHC rate by 10.1 hospice diagnosis data is comparable to patient-level data collection vehicle, percent. the hospice diagnosis data reported in effective 7/1/2014 and to utilize the • A discussion of the Office of the July 27, 2012 FY 2013 Hospice Wage seven NQF-endorsed measures derived Inspector General (OIG) and MedPAC Index notice (77 FR 44242), in which we from the HIS in the hospice quality recommendations to reduce payments to stated that over 77 percent of the reporting program as described in hospices for RHC patients in nursing hospice claims reported only a principal section III.B.4 of the FY 2014 hospice facilities, to account for duplication of diagnosis. wage index and payment update aide services. The claims visit data on Information on a patient’s related and proposed rule (78 FR 27836); and unrelated diagnoses should already be • We proposed that hospices begin aide services revealed that hospice included as part of the hospice national implementation of the Hospice patients in nursing facilities receiving comprehensive assessment and Experience of Care Survey by more visits, but shorter visits than appropriate interventions for the participating in a dry run in January patients at home; however, on average, palliation and management of the 2015 through March 2015, and then, hospice patients in nursing facilities terminal illness and related conditions beginning in April 2015, conduct receive 22 percent more minutes of aide should be incorporated into the monthly implementation of the survey care than hospice patients at home. patient’s plan of care, as determined by through December 2015 to meet the • A discussion of reform research the hospice interdisciplinary group requirements of the 2017 annual findings related to cost reports and (IDG). payment update as described in section general inpatient care (GIP), and a link 5. Transition to ICD–10–CM III.B.6 of the FY 2014 hospice wage to the Abt Hospice Study Technical index and payment update proposed Report and an Abt review of the The proposed rule reminded the rule (78 FR 27837). hospice industry that ICD–10–CM will literature. replace the ICD–9–CM on October 1, C. FY 2014 Hospice Wage Index and • A summary of comments received 2014. A critical issue associated with Rates Update from a December, 2012 CMS Web site the transition to ICD–10–CM involves The proposed updates to the hospice posting about additional data collection the matter of crosswalking between the rates for FY 2014 are as follows: on hospice claims; a forthcoming ICD–9–CM and ICD–10–CM code sets. • Update the hospice wage index Change Request will finalize the data The term ‘‘crosswalking’’ is generally using the 2013 pre-floor, pre-reclassified collection this summer. defined as the act of mapping or hospital wage index as discussed in • An update on the status of the translating a code in one code set to a section III.C.1 of the FY 2014 hospice hospice cost report revisions, which code or codes in another code set. (The wage index and rate update proposed terms ‘‘crosswalking’’ and ‘‘mapping’’ were published as part of a Paperwork rule (78 FR 27839); Reduction Act notice in the Federal are sometimes used interchangeably.) • Update the hospice wage index Register on April 29, 2013. Understanding crosswalking will be taking into account the application of important to physicians during the the hospice floor or budget neutrality E. Technical and Clarifying Regulations transition phase when learning which adjustment factor reduced an additional Text Change new ICD–10 code to use in place of an 15 percent, for a BNAF phase-out of 70 ICD–9 code. We provided information percent as finalized in the FY 2010 We proposed a technical change to regarding the crosswalks from ICD–9– hospice wage index final rule (74 FR correct an erroneous cross reference in CM to ICD–10–CM and this information 39384), as discussed in section III.C.2 of our regulations text at § 418.311, as is available for free and can be the FY 2014 hospice wage index and discussed in section III.E of the FY 2014 downloaded from the NCHS Web site, rate update proposed rule (78 FR Hospice Wage Index and Rate Update www.cdc.gov/nchs/icd/icd10cm.htm. 27840); and proposed rule (78 FR 27847). Hospices should not substitute • Apply the hospice payment update crosswalking for learning and fully percentage, as discussed in section IV. Analysis and Responses to Public implementing ICD–10–CM into their III.C.3 of the FY 2014 hospice wage Comments procedures. Additional information index and rate update proposed rule, to We received approximately 125 regarding the transition to ICD–10–CM the FY 2013 hospice payment rates as comments, many of which contained is available through the CMS Web site discussed in section III.C.4 of the FY multiple comments, on the FY 2014 at: http://www.cms.gov/Medicare/ 2014 hospice wage index and rate hospice wage index and payment rate Coding/ICD10/index.html?redirect=/ update proposed rule (78 FR 27841 update proposed rule. We received icd10. through 27842). comments from various trade B. Hospice Quality Reporting Program D. Update on Hospice Payment Reform associations, private insurers, • We proposed to eliminate two and Data Collection individual hospices, hospitals, currently reported measures, the We did not make any payment reform physicians, medical directors, nurses, structural measure related to Quality proposals or solicit comments on this visiting nurses associations, home Assurance and Performance section, but included updates and a health agencies, hospice volunteers, and Improvement (QAPI) and the NQF discussion of payment reform activities, individuals. We appreciate the #0209 pain measure, and we offered an including: numerous thoughtful and insightful alternate proposal to retain the currently • A discussion of reform options, comments received and believe that reported NQF #0209 pain measure until including the U-shaped curve model, a communication and collaboration a suitable comfort outcome measure is tiered model that uses the U-shaped between CMS and all hospice available as described in section III.B.3 curve, a short-stay add-on payment, and stakeholders is imperative. The of the FY 2014 hospice wage index and case-mix adjustment. comments received and our responses to payment update proposed rule (78 FR • A discussion of rebasing a portion these comments are grouped by subject 27835); of the routine home care (RHC) payment area and are summarized below.

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A. Diagnosis Reporting on Hospice selection of a principal diagnosis. ICD– the proposed rule was to assist hospice Claims 9–CM Coding Guidelines also state to providers in complying with We made no new proposals regarding ‘‘code all documented conditions at the longstanding policies. In our regulations ICD–9–CM Coding Guidelines in the FY time of the encounter/visit, and require at 45 CFR 162.1002, the Secretary 2014 Hospice Wage Index and Payment or affect patient care treatment or adopted the ICD–9–CM code set, Rate Update proposed rule. However, management.’’ The principal diagnosis including The Official ICD–9–CM we did make clarifications regarding reported on the hospice claim form Guidelines for Coding and Reporting. The CMS’ Hospice Claims Processing ICD–9–CM Coding Guidelines for the should be determined by the hospice as the diagnosis most contributory to the Manual (Pub 100–04, chapter 11) selection of principal diagnoses and terminal prognosis. requires that hospice claims include additional diagnoses. These • Hospice providers are expected to other diagnoses ‘‘as required by ICD–9– clarifications are not to preclude any report all coexisting or additional CM Coding Guidelines’’. In the clinical judgment in determining a diagnoses related to the terminal illness proposed rule, we provided guidance beneficiary’s eligibility for hospice and related conditions on the hospice from the ICD–9–CM Official Guidelines services. Eligibility for hospice services claim to be in compliance with existing for Coding and Reporting to highlight is based on meeting the eligibility policy, and provide data needed for coding guidelines for principal and requirements as stated in § 418.20 of our evaluating potential hospice payment other diagnosis selection, as well as the regulations: ‘‘. . . an individual must reform methodologies. various coding and sequencing be— • We reminded providers of the conventions found therein. This (a) Entitled to Part A of Medicare; and transition to ICD–10–CM, which will clarification of the coding guidelines (b) Certified as being terminally ill in replace ICD–9–CM on October 1, 2014. was in response to the monitoring of accordance with § 418.22.’’ • Crosswalking from ICD–9–CM to diagnostic reporting patterns noted on Specifically, we clarified the ICD–10–CM is important for providers hospice claims, especially in regards to following: in understanding the transition between the reporting of only one diagnosis and • ‘‘Debility’’ or ‘‘adult failure to these two code sets. the use of diagnoses not appropriate as thrive’’ should not be used as a We received 109 comments on principal diagnoses per the ICD–9–CM principal hospice diagnosis on the diagnosis reporting on hospice claims, Coding Guidelines. We believe there are hospice claim form per ICD–9–CM which are summarized below according ample, available resources in regards to Coding Guidelines. ‘‘Debility’’ and/or to subsection. the ICD–9–CM Coding Guidelines to ‘‘adult failure to thrive’’ may be used as 1. ICD–9–CM Coding Guidelines support hospice providers who choose another, additional, or coexisting not to have a professional coder diagnosis on the hospice claim form. If The hospice benefit covers all care for complete their hospice claims, ‘‘debility’’ or ‘‘adult failure to thrive’’ is the terminal illness and related including the links provided within the reported as the principal diagnosis on conditions, including the management proposed rule. These free resources are the hospice claim forms, these claims of pain and symptoms. HIPAA, federal available at the following links: http:// will be returned to the provider for more regulations, and the Medicare hospice www.cms.gov/Medicare/Coding/ definitive coding. claims processing manual all require • ICD9ProviderDiagnosticCodes/ Dementia codes classified under that ICD–9–CM Coding Guidelines be index.html?redirect=/ ‘‘Mental, Behavioral and applied to the coding and reporting of ICD9ProviderDiagnosticCodes/, http:// Neurodevelopmental Disorders’’ are diagnoses on hospice claims. Regarding www.cms.gov/medicare-coverage- among the top twenty hospice claims diagnosis reporting on hospice claims, database/staticpages/icd-9-code- reported diagnoses. Many of these codes we clarified in our July 27, 2012 FY lookup.aspx, or on the CDC’s Web site are not appropriate as principal 2013 Hospice Wage Index notice (77 FR at: http://www.cdc.gov/nchs/data/icd9/ diagnoses because of manifestation/ 44247 through 44248) that all providers icd9cm_guidelines_2011.pdf. etiology guidelines or sequencing should code and report the principal Additionally, more information conventions under the ICD–9–CM diagnosis as well as all coexisting and regarding guidance for hospice claims Coding Guidelines. Particular attention additional diagnoses related to the coding can be found in the CMS’ must be paid to dementia diagnoses terminal condition or related conditions Hospice Claims Processing manual (Pub which are found under two separate to more fully describe the Medicare 100–04, chapter 11) available at https:// ICD–9–CM classifications: ‘‘Mental, patients they are treating. www.cms.gov/Regulations-and- Behavioral, and Neurodevelopmental Comment: Several commenters Guidance/Guidance/Manuals/ Disorders’’ and ‘‘Diseases of the Nervous expressed concern that the coding Downloads/clm104c11.pdf. Finally, System and Sense Organs.’’ There are clarification would require that hospices while hospice physicians use their also dementia codes that are classified have a professional coder for coding clinical judgment to determine the under ‘‘Diseases of the Nervous System claims, which would create a financial principal diagnosis and related and Sense Organs’’ that also have burden on hospice providers. Some conditions, we do not require them to sequencing conventions and, therefore, commenters believed that we were determine to the actual codes associated are not appropriate as principal asking hospices to hire professional with those diagnoses for inclusion on diagnoses on the hospice claim. coders. Other commenters thought that the hospice claim. Hospices have the • We provided ICD–9–CM coding we were asking physicians to spend flexibility to determine how to take the guidance regarding the coding of time determining the proper ICD–9–CM physicians’ information about diagnoses principal and other, additional, and/or code for the claim. and translate it into the appropriate coexisting diagnoses. The principal Response: We did not state in the FY codes on the claim. diagnosis should reflect the condition to 2014 hospice wage index and payment be chiefly responsible for the services update proposed rule that any hospice 2. Use of Non-Specific, Symptom provided. ICD–9–CM Coding Guidelines provider would be expected or required Diagnoses specify that the circumstances of an to have a professional coder to complete The proposed rule included inpatient hospital admission diagnosis the coding on the hospice claims. Our additional diagnosis clarifications to are to be used in determining the discussion of the coding guidelines in address current and ongoing diagnosis

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reporting patterns noted on hospice a principal hospice diagnosis reported diseases and determining prognosis is claims, more specifically the use of on the hospice claim and are attempting not always a perfect science. Certifying nonspecific, symptom diagnoses and to take steps to more fully describe their physicians should use their best clinical certain dementia diagnoses. In the patient populations. We will continue to judgment in determining the principal proposed rule, we clarified that the work with our Home Health and diagnosis and related conditions, based ICD–9–CM codes of ‘‘debility’’ and Hospice contractors to ensure that all on the hospice comprehensive ‘‘adult failure to thrive’’ are listed in the LCDs will reflect these principal assessment and review of any and all ICD–9–CM Coding Guidelines under the hospice diagnostic coding clarifications other clinical documentation. classification, ‘‘Symptoms, Signs, and and that those eligible Medicare hospice It remains our belief that the goal of Ill-defined Conditions’’, and are not to beneficiaries will continue to have hospice care is to provide be used as principal diagnoses when a access to the benefits of hospice care. comprehensive, holistic, and related definitive diagnosis has been This collaboration will not be limited to individualized services to eligible established or confirmed by the the release of Change Requests, which Medicare beneficiaries. In order to provider. Therefore, in the proposed can be found on our hospice Web site receive these comprehensive hospice rule, we clarified that ‘‘debility’’ and at http://www.cms.gov/Medicare/ services, Medicare beneficiaries must be ‘‘adult failure to thrive’’ should not be Medicare-Fee-for-Service-Payment/ certified as terminally ill. This used as principal hospice diagnoses on Hospice/Hospice-Transmittals.html. certification is based on the the hospice claim form. When reported Additionally, we encourage all recommendation of the medical director as a principal diagnosis, these would be interested stakeholders to participate in in consultation with, or with input considered questionable encounters for the CMS Home Health and Hospice from, the beneficiary’s attending hospice care, and the claim would be Open Door Forums where questions, physician (if any) and a comprehensive returned to the provider for a more concerns and issues can be addressed assessment of all body systems. The definitive principal diagnosis. with specialists within CMS. hospice regulations require that this ‘‘Debility’’ and ‘‘adult failure to thrive’’ Information regarding Open Door certification be based on a variety of could be reported on the hospice claim Forums can be found on our Web site factors when making the clinical as other, additional, or coexisting at http://www.cms.gov/Outreach-and- determination that a patient has a life diagnoses. The principal diagnosis Education/Outreach/OpenDoorForums/ expectancy of 6 months or less, should reported should be the condition index.html. the illness run its normal course. The determined by the certifying hospice Comment: There were a number of regulations in § 418.25(b), Admission to physician(s) as the diagnosis most commenters who expressed concern hospice care, state, ‘‘In reaching a contributory to the terminal decline. that no longer allowing the use of decision to certify that the patient is Comment: We received numerous ‘‘debility’’ or ‘‘adult failure to thrive’’ as terminally ill, the hospice medical comments in support of or a principal hospice diagnosis would director must consider at least the acknowledging the need for these limit or prohibit access to hospice care following information: diagnostic clarifications and for Medicare beneficiaries. Commenters • Diagnosis of the terminal condition enforcement of existing coding stated that by not allowing these two of the patient. guidelines. Several commenters diagnoses to be coded as a principal • Other health conditions, whether acknowledged understanding the need hospice diagnosis, they believed that related or unrelated to the terminal to identify a principal hospice diagnosis beneficiaries would elect hospice later condition. when a patient has multiple diagnoses in their disease trajectories. Other • instead of using ‘‘debility’’ or ‘‘adult commenters felt that eligible Current clinical relevant failure to thrive.’’ Another commenter beneficiaries would not be admitted to information supporting all diagnoses.’’ stated that their hospice program has hospice care at all because a single Based on this certification and the tried to avoid the use of ‘‘debility’’ as a definitive terminal diagnosis could not Medicare beneficiary’s election of the principal hospice diagnosis and agreed be determined by the certifying hospice benefit, initial and ongoing that this diagnosis has been over-used physician. Other commenters stated that comprehensive assessments are nationally; several commenters it is difficult to determine a single conducted to establish and maintain the acknowledged that there has been principal terminal diagnosis for hospice plan of care. A comprehensive ‘‘sloppy diagnosing’’ with the use of beneficiaries with multiple chronic or hospice plan of care starts with accurate ‘‘debility’’ and ‘‘adult failure to thrive.’’ coexisting conditions. and thorough assessment and One commenter stated that the use of Response: Patient-centered care is at identification of the conditions ‘‘debility’’ or ‘‘adult failure to thrive’’ is the core of the Medicare hospice benefit. (including diseases and symptoms) most often a ‘‘failure to diagnose.’’ One Our mission is to be effective stewards contributing to the terminal prognosis. commenter stated that ‘‘debility’’ cannot of public funds, and we are committed This comprehensive plan of care is to be reported as a cause of the death on to strengthening and modernizing the include all the services and care needed a death certificate in his state and that nation’s health care system to provide for the management and palliation of he had to select a different diagnosis for access to high quality care. We believe the terminal illness and related an immediate cause of death as well as that Medicare beneficiaries who are conditions. This hospice plan of care is a secondary, longer-term related cause. approaching end-of-life are at their most to include the following, per the Several commenters asked what to vulnerable state and should be afforded Hospice Conditions of Participation: expect regarding the application of the the most comprehensive and • Interventions to manage pain and Local Coverage Determination (LCD) responsible clinical judgment. Medicare symptoms; guidelines provided by the Home Health beneficiaries who are hospice eligible • A detailed statement of the scope and Hospice Medicare Administrative should be fully informed by their health and frequency of services necessary to Contractors. care providers, including hospice meet the specific patient and family Response: We appreciate that some providers, as to their conditions needs; hospice providers are recognizing the contributing to their terminal decline • Measurable outcomes anticipated issues regarding the inappropriate use of and their treatment options for ongoing from implementing and coordinating ‘‘debility’’ or ‘‘adult failure to thrive’’ as care. We are aware that diagnosing the plan of care;

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• Drugs and treatment necessary to As ‘‘debility’’ and ‘‘adult failure to conditions.4 We are clarifying these meet the needs of the patient; thrive’’ are nonspecific, ill-defined, coding guidelines so that hospice • Medical supplies and appliances to symptom diagnoses, they should not be providers can be more intentional about meet the needs of the patient; and, reported as principal diagnosis. Rather, addressing all of the beneficiary’s • The interdisciplinary group’s the condition that the hospice medical identified needs as he or she approaches documentation of the patient’s or director determines is most contributory end-of-life. One physician commenter representative’s level of understanding, to the terminal prognosis should be stated that he reviews old records, calls involvement, and agreement with the reported as the principal diagnosis on attending physicians, and uses plan of care, in accordance with the the hospice claim and all other related professional judgment to thoughtfully hospice’s own policies, in the clinical conditions to the terminal prognosis evaluate his patients for hospice care. record (§ 418.56(c)). should be reported as additional Analysis conducted by our hospice A hallmark clinical characteristic of diagnoses. Therefore, the claim should both ‘‘debility’’ and ‘‘adult failure to payment reform contractor, Abt include not only a principal diagnosis, thrive’’ is the presence of multiple Associates, of Medicare hospice but all other related diagnoses as well, primary conditions. According to ICD 9 beneficiaries with ‘‘debility’’ or ‘‘adult to more fully describe the clinical Coding Guidelines, codes that fall under failure to thrive’’ reported as their picture of the terminally ill individual. the classification ‘‘Symptoms, Signs, principal hospice diagnosis, but no and other Ill-defined Conditions’’, such In fact, reporting all of the related conditions that are contributing to the reported secondary diagnoses in FY as ‘‘debility’’ and ‘‘adult failure to 2012 revealed that over 50 percent of thrive’’, can only be used as a principal terminal prognosis on the hospice claim may also further support the eligibility these hospice beneficiaries had seven or diagnosis when a related definitive more chronic conditions and 75 percent diagnosis has not been established or for hospice services. Therefore, we do not believe that these coding had four or more chronic conditions as confirmed by the provider. The identified in the Chronic Condition Data individual diagnosed with ‘‘debility’’ or clarifications will or should create any limitations or barriers to accessing Warehouse. The Chronic Condition Data ‘‘adult failure to thrive’’ may have Warehouse is a research database that multiple comorbid conditions that Medicare hospice services by eligible includes Medicare, Medicaid individually, may not deem the Medicare beneficiaries, as coding on assessments and Part D drug event data individual to be terminally ill. However, claims occurs after the beneficiary is the collective presence of these multiple fully informed and has chosen to elect to support research designed to improve comorbid conditions will contribute to and access hospice services. In fact, the quality of care and reduce cost and the terminal prognosis of the individual. adherence to the ICD–9–CM Coding utilization. These chronic conditions Additionally, Medicare beneficiaries Guidelines should promote access to include: Alzheimer’s disease, non- waive their right to Medicare payment appropriate and comprehensive hospice Alzheimer’s dementia, senile for curative treatments under the services. Medicare beneficiaries should degeneration of the brain, congestive Medicare Hospice Benefit; hospice always expect the right care at the right heart failure, chronic obstructive providers are clinically and ethically time and care that best suits their pulmonary disease, ischemic heart responsible for ensuring that eligible individual clinical status as well as their disease, chronic kidney disease, and Medicare beneficiaries are made fully treatment preferences. Further, some various cancer diagnoses. While these aware of all of the conditions medical experts have argued that these conditions are labeled as chronic, many contributing to their terminal decline so non-specific, ill-defined terms should be of these are often terminal conditions as they can make the informed decision as abandoned because they do not assist in well, while others are contributory to to which treatment approaches they the thoughtful evaluation of patients the terminal prognosis of the individual. would like to pursue. who may have treatable, underlying See Table 3 below:

TABLE 3—CHRONIC CONDITIONS OF THOSE BENEFICIARIES WITH ‘‘DEBILITY’’ OR ‘‘ADULT FAILURE TO THRIVE’’ REPORTED AS PRINCIPAL HOSPICE DIAGNOSIS BUT WITH NO SECONDARY DIAGNOSES REPORTED, FY 2012

Percent

Percent of Beneficiaries with Anemia ...... 76 Percent of Beneficiaries with Alzheimer’s Disease and Related Disorders or Senile Dementia ...... 66 Percent of Beneficiaries with Rheumatoid Arthritis/Osteoarthritis ...... 66 Percent of Beneficiaries with Ischemic Heart Disease ...... 63 Percent of Beneficiaries with Depression ...... 55 Percent of Beneficiaries with Heart Failure ...... 53 Percent of Beneficiaries with Chronic Kidney Disease ...... 43 Percent of Beneficiaries with Chronic Obstructive Pulmonary Disease and Bronchiectasis ...... 39 Percent of Beneficiaries with Osteoporosis ...... 39 Percent of Beneficiaries with Alzheimer’s Disease ...... 38 Percent of Beneficiaries with Stroke ...... 34 Percent of Beneficiaries with Atrial Fibrillation ...... 28 Percent of Beneficiaries with Hip/Pelvic Fracture ...... 20 Percent of Beneficiaries with Asthma ...... 13 Percent of Beneficiaries with Acute Myocardial Infarction ...... 9 Percent of Beneficiaries with Breast Cancer ...... 7 Percent of Beneficiaries with Prostate Cancer ...... 5 Percent of Beneficiaries with Colorectal Cancer ...... 5 Percent of Beneficiaries with Lung Cancer ...... 2

4 Pacala, J.T., Sullivan, G.M. eds. Geriatrics Medicine. 7th ed. New York: American Geriatrics Review Syllabus: A Core Curriculum in Geriatric Society; 2010.

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Percent

Percent of Beneficiaries with Endometrial Cancer ...... 1 Source: FY 2012 hospice claims data from Chronic Conditions Warehouse (CCW), accessed on June 27, 2013. N = 184,924 hospice beneficiaries with principal diagnosis of ‘‘debility’’ or ‘‘adult failure to thrive’’ with no reported secondary diagnoses on the hospice claim.

Comment: Several commenters stated than prognosis, eligibility for hospice principal and other diagnosis codes are that ‘‘Debility’’ is an allowable principal services under the Medicare Hospice to be reported on the hospice claims diagnosis under ICD–9–CM Coding Benefit has always been based on the form per ICD–9–CM Coding Guidelines. Guidelines if there is no established or prognosis of the individual, not Comment: Some commenters felt that confirmed definitive diagnosis. diagnosis, since the implementation of the only reason for the focus on Response: While the ICD–9–CM the Medicare Hospice Benefit in 1983. diagnosis is for CMS to ‘‘save money’’ Coding Guidelines state ‘‘codes that As stated in the proposed rule on while shifting costs to the elderly and describe symptoms, signs, as opposed to August 22, 1983, ‘‘The regulations that the per diem reimbursement is diagnoses, are acceptable for reporting would specify, consistent with the being unbundled with these coding purposes when a related definitive requirements of sections 1812 and clarifications. diagnosis has not been established 1814(a)(8) of the Act, that to be eligible Response: The goal of any (confirmed) by the provider,’’ we for Medicare coverage of hospice care, clarification of longstanding, existing believe that in encompassing the true an individual must be entitled to policies such as those relating to ICD– nature of the holistic hospice Medicare Part A, and must be certified 9–CM Coding Guidelines is to more philosophy, these ill-defined diagnoses as terminally ill’’ (48 FR 38147). These fully describe Medicare beneficiaries are not appropriate as the principal criteria have not changed, and we who are receiving hospice care. We are diagnosis on the hospice claim where an believe that all eligible individuals will also accountable for maintaining the individual has typically had multiple continue to have access to the Medicare integrity and fiscal viability of the health care encounters that have Hospice Benefit. However, certifications Medicare Trust Funds. Diagnosis eventually led to their election of and recertifications of hospice eligibility information on claims is also important hospice services and physician are statutory requirements for coverage as we move forward with hospice certification as being terminally ill. In and payment. The content of the payment reform. Section 3132(a) of the the FY 2014 Hospice Wage Index and certifications and recertifications must Affordable Care Act for hospice Payment Rate Update proposed rule (78 conform to the following requirements payment reform requires that payment FR 27831), we clarified that if any or all at § 418.22(b), Content of certification. reforms occur no earlier than October 1, of these multiple primary conditions (as These requirements include, but are not 2013, and that the revisions to the characterized under ‘‘debility’’ and limited to the following: payments implemented result in the ‘‘adult failure to thrive’’) have been or • The certification must specify that same estimated amount of aggregate are being treated, or if medications have the individual’s prognosis is for a life expenditures for hospice care in the been prescribed for the patient to treat expectancy of six months or less if the fiscal year that the revisions are or manage any or all of these multiple terminal illness runs its normal course. implemented as would have been made primary conditions, we believe that • Clinical information and other for such care in such fiscal year if such these conditions meet the criteria of documentation that support the medical revisions had not been implemented. being established and/or confirmed by prognosis must be in the medical record That means any monies saved from any the beneficiary’s health care provider with the written certification. implemented reform model must go and, thus, ‘‘debility’’ or ‘‘adult failure to • The physician must include a brief back into the hospice benefit. The goal thrive’’ would not be appropriate as the narrative explanation of the clinical of hospice payment reform is to ensure principal hospice diagnosis per ICD–9– findings that supports a life expectancy appropriate distribution of Medicare CM Coding Guidelines. For those of 6 months or less as part of the Trust Funds by better aligning payments beneficiaries who have not had multiple certification and recertification forms or with resource use, to pay more health care encounters prior to hospice as an addendum to these forms. On accurately. election, it is that much more important hospice claims however, we are not However, there has been some that certifying physicians make a seeing the level of completeness of concern, as noted by the Office of the thoughtful evaluation of all of the diagnosis reporting as is required for the Inspector General, that some hospices conditions contributing to an certification and recertifications. As are not providing the full range of individual’s terminal prognosis. The stated in the proposed rule, data required hospice services, most notably physician is responsible for making sure analysis of preliminary hospice claims drugs, through their per diem that the individual electing hospice care data from the first quarter of FY 2013 reimbursement to Medicare hospice is fully aware of all treatment options (October 1, 2012 through December 31, beneficiaries (OIG Report A–06–10– available in order for that individual to 2012) showed that over 72 percent of 00059, June, 2012). Data analysis make the most informed treatment providers only report one diagnosis on conducted by our hospice payment decisions. the hospice claim. Further, analysis of reform contractor, Abt Associates, Comment: Several commenters noted third quarter FY 2013 data (April 1, identified that some hospice-related that hospice eligibility is based on the 2013 through June 30, 2013 as of July 1, drugs for Medicare hospice beneficiaries prognosis and not the diagnosis, and 2013) showed that 69 percent of are being submitted through Part D some expressed concern as to why CMS providers still only report one diagnosis prescription programs instead of being is so focused on the diagnosis. on the hospice claim. The hospice covered under the Medicare Hospice Response: To address the comments claims processing manual (IOM Benefit as required by the statute. In regarding the focus on diagnosis rather Publication #100–04) states that 2010, 773,168 Medicare hospice

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beneficiaries were enrolled in Part D. Of received over 334,000 analgesic hospice enrollment totaling these individuals, almost 15 percent prescriptions through Part D during $13,000,430. See Figure (1) below.

This total covered only one drug is a concerning trend that we do not claims as additional diagnoses in the class. During 2010, Medicare hospice support. appropriate claim fields. beneficiaries received 5,878,425 Therefore, we continue to support the Although claims will not be returned prescriptions of all classes totaling ICD–9–CM Coding Guidelines and stand to the provider until the start of FY $351,750,202. These drug classes by the ICD–9–CM coding clarifications 2015, we remind hospices that they are encompassed other hospice-related in the proposed rule. These coding currently, and have always been, drugs including medications for nausea, guidelines are longstanding policies that required to code all related diagnoses in the additional coding fields on the shortness of breath, anxiety, we have reiterated in past rules and hospice claim and thus should be doing constipation, diarrhea, depression, as notices. No new proposals are being so now. We will continue to monitor well as disease-specific medications for made; rather we are ensuring that these and analyze hospice claims data and the reported principal hospice existing policies are being adhered to. may make further clarifications in the diagnosis. We continue to conduct As such, ‘‘debility’’ and ‘‘adult failure to ongoing analysis regarding the claims future if necessary. In addition to the thrive’’ are not allowable as reportable principal diagnosis field, the paper UC– for Medicare hospice beneficiaries to principal diagnoses on the hospice ensure that hospice providers are 04 claim form has up to 17 additional claims. However, we recognize that this diagnosis fields and the electronic 837I covering the required services, drugs, may be a paradigm shift for some supplies, and DME as required by our 5010 claim form has up to 24 additional hospices in the way they have coded in diagnosis fields allowing for adequate regulations at 42 CFR 418.200, 418.202, the past. Therefore, in recognizing the space for the coding all conditions and 418.204. process and systems changes that need related to the beneficiary’s terminal The hospice reimbursement structure to be put in place, claims received with prognosis. has been a bundled per diem rate since these codes in the principal diagnosis Comment: Many comments were also the implementation of the Medicare field will be returned to the provider for received with specific clinical scenarios Hospice Benefit. It is not our intent to more definitive coding of the principal regarding beneficiaries with a reported ‘‘unbundle’’ any of the services required diagnosis and additional diagnoses, hospice diagnosis of ‘‘debility’’ or to be provided by hospices. However, as effective for claims dated on or after ‘‘adult failure to thrive.’’ These shown in the above figure, it is evident October 1, 2014. This will not affect comments went on to list these that many drugs used for hospice pain claims submitted before October 1, beneficiaries’ comorbidities including management are being ‘‘unbundled’’ 2014. ‘‘Debility’’ and ‘‘adult failure to COPD, atrial fibrillation, congestive from the hospice per diem rate, and this thrive’’ may be reported on the hospice heart failure, and stroke, to name a few.

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Other comments included clinical two or more diagnoses equally meet the hospice patients regardless of diagnosis. presentations, rather than specific criteria for principal diagnosis as The LCD guidelines are intended to be diagnoses, and felt that ‘‘debility’’ or determined by the circumstances of used to identify any Medicare ‘‘adult failure to thrive’’ were the only admission, diagnostic workup and/or beneficiary whose current clinical status appropriate diagnoses that could be therapy provided, and the Alphabetic and anticipated progression of disease is assigned. These commenters also report Index, Tabular List, or other coding more likely than not to result in a life that they were unable to determine the guidelines do not provide sequencing expectancy of six months or less. LCDs principal terminal diagnosis for these direction, any one of the diagnoses may are utilized to determine eligibility for beneficiaries as the individual be sequenced first. The ICD–9–CM Medicare hospice services and not to conditions did not meet criteria for Coding Guidelines are clear that all determine the appropriate diagnoses to being terminally ill per LCDs. Finally, conditions contributing to the need for code on hospice claims. additional commenters asked about services should be listed. The eligibility requirements for quantifying comorbidities and whether One commenter provided the Medicare hospice services were stated Medicare guidelines for eligibility following clinical scenario regarding an above in a previous response. Eligibility would be updated to support individual with a hospice claims- under the Medicare Hospice Benefit is comorbidities as terminal diagnoses. reported principal diagnosis of based on the prognosis of the individual Response: As referenced in our ‘‘debility:’’ and these criteria are not specific to or regulations at § 418.22(b)(1), to be ‘‘A patient has dilated cardiomyopathy and limited by any one condition, multiple conditions or presence of comorbidities. eligible for Medicare hospice services, arrhythmia and has a functional Rather, the certification of terminal the beneficiary’s attending physician (if classification of NYHA Class III as he has symptoms with activity but not at rest. He illness is based in the unique clinical any) and the hospice medical director also has pulmonary fibrosis causing picture of the individual that is reflected must certify that the individual is shortness of breath with activity. His PPS has in the comprehensive assessment and terminally ill, that is, the individual’s declined to 50 percent in the last 3 months other clinical records and prognosis is for a life expectancy of 6 and he now needs to use a walker and the documentation that deems the person as months or less if the terminal illness assistance for one person ambulating <10 ft. having a life expectancy of six months runs its normal course as defined in His weight has declined by 10 percent in the or less, should the illness run its normal section 1861(dd)(3)(A) of the Act and set last six months, and he states that his course. Therefore, the Medicare Hospice out at in § 418.22. Therefore, eligibility appetite has decreased to eating breakfast and drinking two supplements during the day. He Benefit eligibility requirements will not under the Medicare Hospice Benefit is has been hospitalized two times in the past change as a result of the clarifications in based on the prognosis of the individual year for pneumonia and was hospitalized last the proposed rule. We believe that the and not only a single diagnosis or month for arrhythmia requiring medication certifying physicians have the best multiple diagnoses. As generally adjustments. He does not want further hospitalizations.’’ clinical experience, competence and accepted by the medical community, the judgment to make the determination term ‘‘terminal illness’’ refers to an In this scenario, there are multiple that an individual is terminally ill. We advanced and progressively conditions listed, including dilated continue to require the reporting of all deteriorating illness and the illness is cardiomyopathy, arrhythmia and related comorbidities, regardless of the diagnosed as incurable. When an pulmonary fibrosis. Though any of these quantity, in the hospice clinical record individual is terminally ill, many health conditions, individually, may not deem and on the hospice claims. problems are brought on by underlying the individual as terminally ill, the Comment: We received several condition(s), as bodily systems are progressive nature of these diseases as comments regarding whether the interdependent, meaning that there are well as the collective presence of these reported principal diagnosis on the multiple conditions, and hence multiple comorbid conditions will Certificate of Terminal Illness needs to diagnoses, contributing to the terminal contribute to the terminal prognosis of be changed for current hospice prognosis. In the proposed rule, we said the individual. We are clarifying that in beneficiaries where ‘‘debility’’ or ‘‘adult that the ICD–9–CM Coding Guidelines, a scenario such as this, the certifying failure to thrive’’ was reported as the referring to the selection of the principal physician would select the condition he principal terminal condition. diagnosis, state to list the diagnosis or she feels is most contributory to the Response: The regulations at which is ‘‘chiefly responsible for the terminal prognosis, based on § 418.22(b) state that that the services provided and to list additional information in the comprehensive certification include—(1) The codes that describe any coexisting assessment, other relevant clinical certification must specify that the conditions.’’ We clarified that the information supporting all diagnoses, individual’s prognosis is for a life principal diagnosis listed should be and his or her best clinical judgment. expectancy of 6 months or less if the determined by the certifying hospice We are clarifying that this principal terminal illness runs its normal course; physician(s) as the diagnosis most diagnosis, along with the other related (2) Clinical information and other contributory to the terminal prognosis. diagnoses, would be included on the documentation that support the medical Furthermore, ICD–9–CM Coding hospice claim. The physician’s clinical prognosis must accompany the Guidelines state that when there are two judgment does not negate the fact that certification and must be filed in the or more interrelated conditions (such as there must be a basis for hospice medical record with the written diseases in the same ICD–9–CM chapter certification. A hospice needs to be certification as set forth in paragraph or manifestations characteristically certain that the physician’s clinical (d)(2) of this section. Initially, the associated with a certain disease) judgment can be supported by clinical clinical information may be provided potentially meeting the definition of information and other documentation verbally, and must be documented in principal diagnosis, either condition that provide a basis for the certification the medical record and included as part may be sequenced first, unless the of a life expectancy of six months or less of the hospice’s eligibility assessment; circumstances of the admission, the if the illness runs its normal course. (3) The physician must include a brief therapy provided, the Tabular List, or Additionally, the LCDs state that the narrative explanation of the clinical the Alphabetic Index indicate terminal illness eligibility guidelines findings that supports a life expectancy otherwise. In the unusual instance when provided therein are applicable to all of 6 months or less as part of the

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certification and recertification forms, or captured on the Medicare hospice An 85 year old patient with dysphagia, as an addendum to the certification and claims to more accurately describe decreased oral intake, malnutrition, weight recertification forms; (4) The physician hospice beneficiaries receiving the loss, BMI of 18.6 upon admission, decreasing or nurse practitioner who performs the services, drugs, supplies, and DME functional status, progressed from a walker to chair to bed in less than six months, but with face-to-face encounter with the patient hospices are required to cover under the no underlying diagnoses. This patient was described in paragraph § 418.22(a)(4) regulations at § 418.200, § 418.202, and determined to be terminally ill by the must attest in writing that he or she had § 418.204. A non-specific, ill-defined certifying physician and this patient was a face-to-face encounter with the symptom diagnosis such as ‘‘debility’’ entered into hospice services. patient, including the date of that visit. and ‘‘adult failure to thrive’’ is more of In this example, while no organ-based a catch-all diagnosis in that a wide The attestation of the nurse practitioner diagnosis could be confirmed by the or a non-certifying hospice physician variety of principal and/or comorbid certifying physician, the clinical record shall state that the clinical findings of conditions contribute to these reflects that this patient was suffering that visit were provided to the certifying syndromes. Given the complexity of a from malnutrition, dysphagia, and physician for use in determining hospice patient, with multiple decreased functional status and muscle continued eligibility for hospice care; conditions often contributing to the weakness. and (5) All certifications and terminal prognosis, we are stating that Eligibility for hospice services is not recertifications must be signed and all diagnoses contributing to (that is, limited by only disease-specific ICD–9– related to) the terminal prognosis of the dated by the physician(s), and must CM codes. There are ICD–9–CM codes include the benefit period dates to individual are to be reported on the for all of the clinical presentations listed which the certification or recertification hospice claims in order to account for above. This clinical scenario has been applies. the individual needs of each and every documented in the comprehensive Certifications (of which the narrative Medicare hospice beneficiary. is a part) are based on prognosis, not In evaluating an individual for assessment, and there is a clinical diagnosis as described above in the hospice eligibility, and especially when history of this patient’s decline. CMS’s Code of Federal Regulations. Claims evaluating an individual who has the expectation is to code these clinical should include a principal diagnosis clinical characteristics found under presentations on the claim as they are and all related diagnoses which form ‘‘debility’’ or ‘‘adult failure to thrive’’, listed in the clinical record. The the prognosis. Certifications are ‘‘medical history is probably more condition the physician feels is most completed no more than 15 days prior important than physical examination or contributory to the terminal prognosis to the start of the benefit period. A new laboratory testing as failure to thrive would be reported first on the hospice certification is not required simply commonly occurs over the course of claim form, along with all other related because a beneficiary’s principal months and common diagnostic testing conditions. There appears to be some confusion and disconnect from the diagnosis changes nor do benefit has generally been done previously.5 ’’ comments received regarding the coding periods or election status change simply Therefore, it is our belief that an expectations. The rationale for these because a principal diagnosis changes. individual who has elected hospice care clarifications is not to limit or prohibit Comment: We received some and has been determined to be access to hospice services, and we comments expressing concern that no terminally ill by a certifying physician expect hospice providers to render the longer allowing the use of ‘‘debility’’ has more than likely already been hospice care needed for those eligible and ‘‘adult failure to thrive’’ as principal assessed, treated and evaluated by individuals. We are only clarifying to hospice diagnoses would mean that health care providers, not limited to just code this level of specificity on the Medicare hospice beneficiaries would hospice providers, prior to coming to hospice claim form so we have an be forced into a Medicare ‘‘cookie the decision to elect hospice services accurate clinical picture of those cutter’’ mold diagnosis. Several and waive the right to Medicare Medicare beneficiaries that are receiving commenters stated that this would mean payment for other curative services. hospice care under their Medicare expensive diagnostic testing and/or Having all related conditions reported Hospice Benefit. This expectation for hospitalizations to determine the on the hospice claim form, and not just specificity in claims coding is found in terminal condition. Some commenters a single diagnosis, such as an ill- every other health care setting for question what the expectations are for defined, symptom diagnosis, will ensure Medicare beneficiaries—inpatient, those people who are just ‘‘dying of old that hospices are aware of and provide outpatient, home health, skilled nursing age’’ and some asked if CMS would all of the expert care, including services, facilities, acute rehabilitation facilities rather see ‘‘otherwise healthy but drugs, supplies, and DME, that a and in long term care hospitals. elderly patients experience multiple Medicare hospice beneficiary requires Hospices are expected to follow the hospital admissions and nursing home as he or she approaches end-of-life. stays.’’ Another commenter stated that In the rare event that no single same level of specificity especially doctors may feel compelled to ‘‘make- definitive terminal diagnosis (or given the complexity of the hospice up’’ diagnoses to satisfy this coding diagnoses) can be determined by the patient population. We recognize that this may be a great clarification. One commenter asked if certifying physician, whether from lack departure from the way some hospice all codes under the classification of of clinical documentation or patient providers have been accustomed to ‘‘Symptoms, Signs, and Ill-defined refusal for diagnostic work-up, then the coding on hospice claims. Ongoing Conditions’’ are included in these expectation would be that all conditions analysis of the hospice claims reveals clarifications. that are present at the time of hospice that a majority of hospices are coding a Response: As stated above, these ICD– certification that deem the individual as single terminal diagnosis. However, 9–CM coding clarifications do not terminally ill would be reported on the eligibility should always have been preclude the clinical judgment of the hospice claim. One example provided based on the terminal prognosis of the certifying physician(s) regarding the by a commenter is as follows: hospice eligibility of any given patient, and this prognosis would Medicare beneficiary; rather, they are to 5 Verdery, R. (1997). Clinical Evaluation of typically involve more than one ensure that all principal and diagnoses Failure to Thrive in Older People. Clinics in diagnosis. Specifically, as stated related to the terminal prognosis are Geriatric Medicine. 13(4), 769–778. previously, analysis of third quarter FY

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2013 data (April 1, 2013 through June requirement, and advanced age alone is conditions that are contributing to the 30, 2013 as of July 1, 2013) showed that inadequate documentation of terminal terminal prognosis of their patients. We 69 percent of providers still only report prognosis. expect that they will use responsible one diagnosis on the hospice claim. It is normal clinical practice for health decision making to determine the Prognosis, as many commenters have care providers to fully inform their diagnosis contributing most to the noted, is based on a multitude of patients about their health status. An terminal prognosis utilizing the clinical processes. We expect hospices eligible beneficiary who is considering information from the clinical records to code these multiple clinical hospice, and who has not seen a doctor and the comprehensive assessments. processes. This may be difficult for in years, should be fully informed by While the ICD–9–CM Coding Guidelines some providers to accept as they may the potential hospice provider about the for ‘‘Symptoms, Signs and Ill-defined not understand how malnutrition, conditions contributing to their terminal Conditions’’ do apply for all codes anemia, or depression, for example, prognosis and their palliative treatment under this ICD–9–CM classification, we could be reported as a principal hospice options for ongoing care. are currently focusing on the two most diagnosis. However, many commenters Often, many other treatable health frequently reported hospice claims provided clinical scenarios in which conditions could be contributing to the diagnoses from this classification, their patients had one or all of these clinical characteristics associated with ‘‘debility’’ and ‘‘adult failure to thrive.’’ clinical presentations that was ‘‘debility’’ and ‘‘adult failure to However, we will continue to monitor contributing to the terminal prognosis of thrive.’’ 7 These conditions may include: the diagnostic coding patterns on the individual. We expect hospice Alzheimer’s Disease, depression, hospice claims for any further issues or providers to take a holistic approach to primary anorexia, diabetes, cancer, clarifications that may be needed in this diagnostic coding on the claims form, chronic lung disease, stroke, chronic regard. reporting the principal diagnosis and all urinary tract infections, chronic steroid Comment: A few commenters related diagnoses. use, medication reactions, just to name suggested, for those cases reported with According to § 418.22(b)(3), Content a few. Any eligible individual (or ‘‘debility’’ or ‘‘adult failure to thrive’’ as of certification, ‘‘The physician must representative) who is electing hospice the principal diagnosis, there should be include a brief narrative explanation of under the Medicare Hospice Benefit a mandatory medical review rather than the clinical findings that supports a life must acknowledge that he or she has these patients not receiving hospice care expectancy of six months or less as part been given a full understanding of the or to only ‘‘punish’’ those that have of the certification and recertification palliative rather than the curative nature abused ‘‘debility.’’ One commenter forms; or as an addendum to the of hospice care, as it relates to the suggested that CMS limit the number of certification and recertification forms.’’ individual’s terminal illness patients per hospice with ‘‘debility’’ and Note that ‘‘clinical findings’’ are (§ 418.24(b)(2)). Upon electing the ‘‘adult failure to thrive’’ with a 3 percent included in the determination of Medicare hospice benefit, an eligible cap. terminal prognosis, and hospice patient acknowledges his/her Response: As noted previously, eligibility is not limited by or to a single understanding that Medicare will no ‘‘debility’’ and ‘‘failure to thrive’’ diagnosis or diagnostic test result(s). longer pay for curative treatment for the comprised 20 percent of the Medicare Therefore, expensive diagnostic testing terminal illness and related conditions, hospice population in FY 2012. This is or hospitalizations are not a requirement and thus the patient is essentially a substantial number of individuals that for determining whether an individual waiving curative treatment under hospice providers are saying have no meets Medicare hospice eligibility Medicare, and instead elects to receive other diagnoses or conditions that could criteria if the individual’s clinical palliative care to manage pain or be determined or confirmed. circumstances are evident in that the symptoms. It is the hospice provider’s Conducting mandatory medical reviews conditions present contribute to the responsibility to ensure that the on each and every one of these cases terminal prognosis of the individual. individual is fully informed and would require substantial Oftentimes, if an individual has acknowledges understanding that he or administrative burden and costs. Rather, reported a past, resolved problem in she is essentially waiving curative we are not stating that individuals with their medical history, and that problem treatment and electing only palliative the clinical manifestations of ‘‘debility’’ could cause the symptom syndromes of care, so the individual (or and ‘‘adult failure to thrive’’ are ‘‘debility’’ or ‘‘adult failure to thrive’’, representative) can make his or her own ineligible for hospice services under the that problem is the most likely one informed decision. Medicare Hospice Benefit. Eligibility is underlying the patient’s presentation.6 The expectation remains that all determined by the certifying physician The expectation remains that hospice conditions (hence, diagnoses) that are and based on the review of the clinical providers, using their best clinical contributing to (that is, related to) the records and comprehensive assessment. judgment, knowledge, and expertise, terminal prognosis of the individual These clarifications are to ensure that will ‘‘paint’’ a detailed picture of their would be reported on the hospice hospice providers are fully describing patients to more fully describe Medicare claims to fully represent the their Medicare hospice patients, which hospice patients. individual’s clinical status and the should assist them in fully If a Medicare beneficiary is reported hospice interventions that are being understanding and treating all of the conditions contributing to the terminal to be ‘‘dying of old age’’ or ‘‘otherwise provided to address the individual’s prognosis and not just a single terminal healthy, but elderly,’’ we believe that needs. characterization of the beneficiary’s We do not endorse ‘‘making up’’ a diagnosis. It is our belief that hospice providers condition is inconsistent with diagnosis in order for hospice claims would not support having another cap classifying the individual as terminally submission. We believe that requirement regarding their census ill. Eligibility criteria for the Medicare beneficiaries’ physicians are in the best populations. We recognize there are Hospice Benefit do not include an age clinical position to determine those many new and ongoing requirements 6 Verdery, R. (1997). Clinical Evaluation of 7 Verdery, R. (1997). Clinical Evaluation of that hospice providers must fulfill in Failure to Thrive in Older People. Clinics in Failure to Thrive in Older People. Clinics in addition to providing high-quality, end- Geriatric Medicine. 13(4), 769–778. Geriatric Medicine. 13 (4), 769–778. of-life care for Medicare beneficiaries.

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Therefore, it is not our intent, at this that allow for the inclusion of multiple TABLE 5—PERCENTAGE OF CLAIMS time, to implement any new cap diagnoses. However, data analysis of WITH ‘‘DEBILITY’’ OR ‘‘ADULT FAIL- requirements or ‘‘punishments’’ on hospice claims continues to show that URE TO THRIVE’’ AS REPORTED hospice providers with these coding the majority of hospice providers (69 PRINCIPAL DIAGNOSIS WITH NO RE- clarifications. We expect that hospice percent of hospice providers, as stated PORTED SECONDARY DIAGNOSES providers will continue to assess and in previous responses) continue to evaluate their own organizational report only one diagnosis on hospice FY 2011 FY 2012 policies and processes to ensure that claims. Additionally, software systems Condition (%) (%) they are able to meet requirements and are typically designed with end user to continue to meet the needs of their input so we believe those software Debility ...... 11.96 12.07 patients. systems that only allow one diagnosis Adult Failure to Thrive ...... 7.55 7.83 Comment: One commenter stated, were because those hospices ‘‘The need to document secondary communicated to the software vendors Source: FY 2011 and FY 2012 Claims data diagnoses is recognized. It was actually that their needs for claims coding were from Chronic Conditions Warehouse (CCW). commonly done in the pre-electronic Accessed on 7/19/13. to include only one diagnosis. We record (EMR) days, but got lost by many expect hospices to articulate to the This data indicates that the majority hospices with limitations in software of hospice providers are reporting systems’’. One commenter stated that vendors the requirements of the software that complies with our ‘‘debility’’ and ‘‘adult failure to thrive’’ barriers existed with electronic medical as a principal hospice diagnosis, thus record systems that did not allow requirements. Furthermore, we have reiterated in past notices and rules this is not a rare occurrence as additional diagnoses to flow to the commenters have stated. Additionally, claim. These commenters went on to say regarding our expectation of the claims with ‘‘debility’’ or ‘‘adult failure that many of these barriers have been inclusion of the principal hospice to thrive’’ as the reported principal removed and that the majority of diagnosis as well as all related hospice diagnosis accounted for almost hospice providers are either now in conditions. As mentioned previously, in 20 percent of total hospice claims for compliance with the requirement to addition to the principal diagnosis field, both FY 2011 and FY 2012. include multiple diagnoses or are in the the paper UC–04 claim form has up to Comment: We received several process of implementing procedures 17 additional diagnosis fields, and the comments regarding hospice claims and technology in order to be in electronic 837I 5010 claim form has up with a principal diagnosis of ‘‘debility’’ compliance. One commenter stated that to 24 additional diagnosis fields or ‘‘adult failure to thrive’’ being their hospice software vendor has not allowing for adequate space for the returned to the provider immediately for developed a process to allow for coding all conditions contributing to inclusion of related diagnoses on their (that is, related to) the beneficiary’s more definitive coding. Some expressed that CMS is ‘‘jumping the gun’’ by claims forms. This commenter went on terminal condition. Therefore, we announcing that claims would be further to say that it would be an believe that we have provided ample returned to the provider before the obstacle for hospice providers to make notice and time for hospice providers to comment period is over and were software changes to comply with the evaluate their claims software systems concerned that claims would starting ICD–9–CM coding clarifications to make the necessary systems returning upon publication of the regarding the reporting of related adjustments for the inclusion of all diagnoses. Several commenters stated proposed rule. Several commenters related diagnoses. However, we also expressed concern regarding the ‘‘denial that the occurrence of reporting a recognize that this will require some principal diagnosis of ‘‘debility’’ or of claims payment’’ for claims received software systems adjustments for several with ‘‘debility’’ or ‘‘adult failure to ‘‘adult failure to thrive’’ is uncommon. hospice providers, and we are sensitive Response: We appreciate the thrive’’ reported as the principal to those time requirement needs. To diagnosis. comment regarding the common address the comments regarding the rare hospice practice of including secondary Response: We apologize for any occurrences of the use of ‘‘debility’’ or diagnoses in the past. While we confusion that may have resulted from ‘‘adult failure to thrive’’ as a principal understand that software systems may our statement in the FY 2014 Hospice diagnosis, a review of 2011 and 2012 pose some obstacles in reporting more Wage Index and Payment Rate Update than one diagnosis on the hospice data from the Chronic Condition proposed rule regarding claims being claim, we also believe that this practice Warehouse revealed the following returned to providers for more definitive of reporting the conditions contributing information (See Table 4 and Table 5): coding. We stated in the proposed rule: to (that is, related to) the terminal ‘‘. . . we would clarify that ‘‘debility’’ prognosis is one that has been TABLE 4—PERCENTAGE OF HOSPICE and ‘‘adult failure to thrive’’ would not communicated since the PROVIDERS EVER REPORTING ‘‘DE- be used as principal diagnoses of the implementation of the hospice benefit. BILITY’’ OR ‘‘ADULT FAILURE TO hospice claim form. When reported as a The expectation is for this practice to THRIVE’’ AS THE PRINCIPAL HOSPICE principal diagnosis, these would be continue and for hospice providers to be DIAGNOSIS WITH NO REPORTED considered questionable encounters for active in ensuring that their processes SECONDARY DIAGNOSES hospice care, and the claims would be and systems promote the hospice returned to the provider, not denied, for philosophy of holistic, comprehensive FY 2011 FY 2012 a more definitive principal diagnosis.’’ care and the intent of the Medicare Condition % % We did not specify any time frame for Hospice Benefit in supporting that these claims or the effective date of access for the Medicare population. Debility ...... 89.3 88.9 implementation. The intent was not to As mentioned in the proposed rule, Adult Failure to immediately return claims to the there are hospice providers who are Thrive ...... 87.3 87.6 provider upon publication of the reporting more than just the principal Source: FY 2011 and FY 2012 Claims from proposed rule, and the returned claim is diagnosis, so it appears that there are Chronic Conditions Warehouse (CCW). not a denial of the claim, but a request electronic systems currently in place Accessed on 7/19/13. for a more definitive and appropriate

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principal diagnosis. ‘‘Debility’’ and complications and risk factors that affect eligibility is related to the prognosis of ‘‘adult failure to thrive’’ could be care planning; functional status; the individual. One example provided reported on the hospice claim as other, imminence of death; and severity of from a hospice physician regarding a additional, or coexisting diagnoses. We symptoms (§ 418.54(c)). The Medicare Medicare hospice beneficiary who had a understand that this is a shift from the Hospice Benefit requires the hospice to reported principal terminal diagnosis of way some hospice providers have coded cover all palliative care related to the chronic obstructive pulmonary disease in the past and that there needs to be terminal illness and related conditions. (COPD). This individual also had adequate time to ensure that all clinical The hospice plan of care is established documented coronary artery disease and electronic processes are in place based on the review of the clinical (CAD) and Parkinson’s disease. The and functioning as not to create records and the comprehensive hospice provider stated that the CAD and the unnecessary administrative burden in assessments in order to ensure that all Parkinson’s disease are unrelated to the an accelerated time frame. care needs at the end-of-life are COPD and that the patient would only Comment: There were several addressed. Section 1861(dd)(1) of the receive hospice services for the COPD. comments questioning what is Act establishes the services that are to This scenario and accompanying considered related or unrelated to the be rendered by a Medicare certified statement does not appear to encompass terminal condition. One commenter hospice program. These covered hospice philosophy of holistic care. stated that it is difficult to determine if services include: Nursing care; physical Therefore, we are restating what we a diagnosis is related to the terminal therapy; occupational therapy; speech- communicated in the December 16, condition with an example given stating language pathology therapy; medical 1983 Hospice final rule regarding what that renal failure may or may not be social services; home health aide is related versus unrelated to the related to congestive heart failure. services (now called hospice aide terminal illness: ‘‘. . . [W]e believe that Another commenter, a hospice services); physician services; the unique physical condition of each physician, provided a clinical scenario homemaker services; medical supplies terminally ill individual makes it for a beneficiary with chronic (including drugs and biologics); medical necessary for these decisions to be made obstructive pulmonary disease (COPD) appliances; counseling services on a case-by-case basis. As stated in the as the principal diagnosis, but who also (including dietary counseling); short- December 16, 1983 Hospice final rule, had coronary artery disease (CAD) and term inpatient care (including both . . . ‘‘hospices are required to provide Parkinson’s disease which the hospice respite care and procedures necessary virtually all the care that is needed by considered unrelated comorbid for pain control and acute or chronic terminally ill patients.’’ (48 FR 56010). conditions. The patient would only symptom management) in a hospital, Therefore, unless there is clear evidence receive hospice services for care related nursing facility, or hospice inpatient that a condition is unrelated to the to the lung disease (COPD). Another facility; continuous home care during terminal prognosis, all services would commenter expressed concern that periods of crisis and only as necessary be considered related. It is also the including all of the related diagnoses on to maintain the terminally ill individual responsibility of the hospice physician the hospice claim would mean that at home; and any other item or service to document why a patient’s medical hospices would have additional costs which is specified in the plan of care need(s) would be unrelated to the incurred in covering all of the and for which payment may otherwise terminal prognosis. We continue to medications for the reported diagnoses. be made under Medicare, in accordance reiterate that this determination of what Response: It is our goal to maintain with Title XVIII of the Act. is related versus unrelated to the the integrity of hospice philosophy and terminal prognosis remains within the the Medicare Hospice Benefit. The We recognize that there are conditions clinical expertise and judgment of the intent of the Medicare Hospice Benefit that are unrelated to the terminal hospice medical director in is to provide all-inclusive care for pain condition of the individual. This is why collaboration with the IDG. relief and symptom management for the there are the ongoing assessment Comment: Two commenters stated terminal prognosis and related requirements of the hospice that the reference to the 1983 final rule conditions, and offer the opportunity to beneficiaries and the collaboration with preamble language quoted above, is die with dignity in the comfort of one’s the hospice IDG—to ensure that the casting aside language found in the home rather than in an institutional ongoing and changing needs of the § 418.402, ‘‘Individual liability for setting. It is often not a single diagnosis hospice beneficiary are assessed and services that are not covered hospice that represents the terminal prognosis of changes to the plan of care are made. care’’. These comments went on to say the patient, but the combined effect of However, in referring to the holistic that § 418.402 ‘‘identified items as several conditions that makes the intent of hospice philosophy and care, unrelated and not the responsibility of patient’s prognosis terminal. In we wrote in the August 22, 1983 the hospice for ‘services received for the § 418.54(c), the hospice Conditions of proposed rule, ‘‘. . . we recognize that treatment of an illness or injury not Participation stipulate that the there are many illnesses which may related to the individual’s terminal comprehensive hospice assessment occur when an individual is terminally condition’.’’ must identify the patient’s physical, ill which are brought on by the Response: The referenced § 418.402, psychosocial, emotional, and spiritual underlying condition of the patient’’ (48 ‘‘Individual liability for services that are needs related to the terminal illness and FR 38147). In reviewing the many not considered hospice care’’ states, related conditions which must be clinical scenarios provided by ‘‘Medicare payment to the hospice addressed in order to promote the commenters and their interpretations of discharges an individual’s liability for hospice patient’s well-being, comfort, what they consider related versus payment for all services, other than the and dignity throughout the dying unrelated, it is apparent that the hospice coinsurance amounts described process. The comprehensive assessment majority refer to a ‘‘related condition’’ as in § 418.400. . .’’ This section goes on must take into consideration the one that is related only to the reported to state what payment liabilities a following factors: The nature and single, principal terminal diagnosis and hospice beneficiary would be condition causing admission (including not to the terminal prognosis. However, responsible for (not the hospice the presence or lack of objective data within those same comments, it was provider per the commenters) including and subjective complaints); stated numerous times that hospice ‘‘. . . Medicare deductibles and

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coinsurance payments and for the accountability and value-based models in the collaborative process as health difference between the reasonable and of care. care navigates through the 21st century actual charge on unassigned claims on Comment: One commenter stated that and health care reform provisions. We other covered services that are not these diagnostic clarifications are a continue to have ongoing discussions considered hospice care.’’ Examples of change in coverage policy and CMS with the industry, including the non-hospice services are provided in must use a National Coverage Decision national hospice organizations, to this section including ‘‘. . . Medicare process to change coverage policy rather remain aware of the issues that affect services received for the treatment of an than through the preamble discussion of the hospice providers and impact illness or injury not related to the the proposed rule. Medicare beneficiaries. We believe that individual’s terminal condition.’’ We Response: We continue to state that this communication and collaboration have previously acknowledged that these coding clarifications are for will reflect in our ongoing advocacy for there are those rare circumstances in hospice claims reporting only and are the Medicare hospice beneficiaries to which a service may not be related to not a question of hospice eligibility or ensure accountability, responsibility the patient’s terminal prognosis and that access to coverage. Eligibility to access and quality end-of-life care. We will this determination is to be done on a the Medicare Hospice Benefit remains continue to provide outcomes of these case-by-case basis by the hospice the same since the implementation of communications via Medicare Learning physician with input from the IDG. the benefit in 1983. To restate, eligibility Network (MLN) articles and through our However, § 418.402 refers to the liability for the Medicare Hospice Benefit is Open Door Forums to ensure that all limitations for the hospice beneficiary based on the individual being entitled to Medicare stakeholders are kept and does not refer to the liability to the Part A of Medicare and being certified informed of progress in maintaining the hospice provider. To infer that this as terminally ill in accordance with integrity of the Medicare Hospice section is a confirmation of the liability § 418.22. These eligibility requirements Benefit. limitations to the hospice provider for coverage have not changed and are Final Decision: We will require these would be incorrect. not changing in this rule. We expect coding changes beginning on October 1, hospice providers will not discharge, Comment: Several commenters stated 2014. On or after October 1, 2014, any from hospice services, those that the hospice physician, along with claims with ‘‘debility’’ or ‘‘adult failure beneficiaries who meet eligibility input from the IDG, have a process in to thrive’’ in the principal diagnosis requirements but for whom they cannot place to help determine related versus field will be returned to the provider for determine a single, principal hospice more definitive principal diagnosis unrelated conditions and results in the diagnosis. If a Medicare beneficiary coding. Claims submitted prior to holistic and comprehensive care their meets the eligibility requirements as October 1, 2014 with ‘‘debility’’ or patients need. Other commenters stated in § 418.20 and as referenced ‘‘adult failure to thrive’’ in the principle explained that the software system above, that Medicare beneficiary will diagnosis field on the claim will not be utilized by their hospice agency marks have access to hospice services under returned to the provider, but we expect conditions either as ‘‘active’’ (meaning, the Medicare Hospice Benefit. The that hospice providers will code the related) or ‘‘historical’’ (meaning, intent of these coding clarifications is to principal hospice diagnosis according to unrelated). If a condition went from a request more clarity and detail on the the ICD–9–CM Coding Guidelines and historical state to an active state during hospice claims to reflect a complete the clarifications made herein. This the course of a hospice episode, then picture of the Medicare hospice should provide more than ample time that condition was then considered population and the hospice services for hospice providers to meet with related and treated accordingly under rendered and not to make any changes clinical staff and their software vendors the hospice plan of care. Another in coverage or eligibility policies. to ensure that these coding needs are commenter said that while some Therefore, we reject the comment that addressed and processes put into place conditions are unrelated to the terminal CMS must use the National Coverage to ensure continuity of care and condition, the clinical manifestations of Decision process. systems. These returned claims, based these unrelated conditions are as such Comment: We received a few on the principal diagnoses of ‘‘debility’’ that they contribute to the individual’s suggestions to help further clarification or ‘‘adult failure to thrive,’’ are not a symptom burden, and the hospice regarding diagnostic coding in the denial of payment because of provider still provides symptom hospice setting. One commenter questionable eligibility; rather, these management for these seemingly suggested that CMS work with the claims are being returned for additional unrelated conditions to meet the National Hospice and Palliative Care clarity. Once resubmitted with patient’s needs. Organization (NHPCO) to develop diagnostic codes following the ICD–10– Response: We applaud these hospices guidelines regarding diagnostic coding CM Coding Guidelines, these claims will in providing a patient-centered for hospices. Another commenter be processed and paid accordingly. approach and embracing the holistic suggested that CMS needs to guide However, we expect hospice providers hospice philosophy. These are all standardization of the hospice industry. to transition immediately to more examples of hospice providers coming The American Academy of Hospice and thoughtful coding practices in advance up with innovative ways to manage the Palliative Medicine (AAHPM) suggested of this effective date. needs of the hospice beneficiaries. collaboration with CMS to convene a These are reflections of the true intent Palliative Medicine and Hospice Coding 3. Use of ‘‘Mental, Behavioral and of hospice philosophy that have been and Documentation Learning Network Neurodevelopmental Disorders’’ ICD–9– incorporated into the Medicare Hospice to have ongoing dialogue regarding CM Codes Benefit. We encourage all hospice coding issues and suggestions for the In the proposed rule we discussed the providers to assess their operational hospice industry. use of hospice claims-reported principal processes and clinical and claims Response: We appreciate the hospice diagnoses that fall under the systems to be innovative in meeting the numerous thoughtful and insightful ICD–9–CM classification, ‘‘Mental, challenges of providing end-of-life care suggestions that have been provided in Behavioral and Neurodevelopmental for the Medicare hospice beneficiaries response to the diagnostic clarifications. Disorders.’’ There are several codes that as health care, in general, transitions to CMS strives to involve all stakeholders fall under this classification that

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encompass multiple dementia diagnoses combination exists, there is a ‘‘use hospice claim. Instructional notes that are frequently reported principal additional code’’ note at the etiology regarding the sequencing convention for hospice diagnoses on hospice claims, code, and a ‘‘code first’’ note at the each of these codes can be found under but are not appropriate principal manifestation code. These instructional each of these codes in the Tabular List diagnoses per ICD–9–CM Coding notes indicate the proper sequencing within the ICD–9–CM Official Guidelines. There are, however, other order of the codes, etiology followed by Guidelines for Coding and Reporting. ICD–9–CM dementia codes, such as manifestation.’’ In most cases, these Therefore, it is imperative that hospice those for Alzheimer’s disease and manifestation codes will have in the providers understand and follow ICD– others, that fall under the ICD–9–CM code title, ‘‘in diseases classified 9–CM Coding Guidelines and classification, ‘‘Diseases of the Nervous elsewhere’’ or ‘‘in conditions classified sequencing rules for all diagnoses and System and Sense Organs’’ which are elsewhere.’’ Codes with this in the title especially those noted above. We acceptable as principal diagnoses per are a component of the etiology/ encourage hospice providers to pay ICD–9–CM coding guidelines. manifestation convention. The codes particular attention to dementia coding Comment: One commenter expressed with the phrase ‘‘in diseases classified as there are dementia codes found in concern that ‘‘Lewy Body Dementia,’’ elsewhere’’ or ‘‘in conditions classified more than one ICD–9–CM classification ‘‘Fronto-temporal Dementia’’ and elsewhere’’ in the title indicate that they chapter, and there are multiple coding ‘‘Vascular Dementia’’ are no longer are manifestation codes. ‘‘In diseases guidelines associated with these allowed as principal hospice diagnoses. classified elsewhere’’ or ‘‘in conditions dementia conditions. Another commenter questioned what classified elsewhere’’ codes are never The clarification of these coding would be the recommendation if the permitted to be used as first listed or guidelines is not to determine eligibility hospice provider is unable to determine principal diagnosis codes and they must for hospice services, but rather, these the cause of the dementia either from a be listed following the underlying guidelines are to assist with the proper lack of medical records or specific condition. However, there are coding sequences for the hospice diagnostic work-up. One commenter manifestation codes that do not have ‘‘in claims. Eligibility for Medicare hospice asked if the LCD for ‘‘Alzheimer’s diseases classified elsewhere’’ or ‘‘in services continues to be based on the Disease and Related Disorders’’ would conditions classified elsewhere’’ in their prognosis of the individual based on the be applicable to use for coding title. For such codes a ‘‘use additional clinical judgment of the certifying guidance. code’’ note would still be present, and physician that the individual has a life Response: In the FY 2014 Hospice the rules for coding sequencing still expectancy of 6 months or less if the wage index and payment rate update apply. We noted that several dementia terminal condition runs its normal proposed rule (78 FR 27823), we did not codes which are not allowable as course. CMS does not make any state the specific dementia conditions principal diagnoses per ICD–9–CM recommendations as to what specific and their corresponding ICD–9–CM coding guidelines are under the diagnoses to select from the ICD–9–CM codes that fall under various coding and classification of ‘‘Mental, Behavioral Official Guidelines for Coding and sequencing conventions in the ICD–9– and Neurodevelopmental Disorders.’’ Reporting for an individual beneficiary CM Coding Guidelines. There are many According to the ICD–9–CM Coding as these selections are to be determined codes for dementia conditions, Guidelines for ‘‘Mental, Behavioral and by the certifying physician(s) based on including the neurological causes as Neurodevelopmental Disorders’’, the clinical record review and the well as the clinical mental and comprehensive assessment. There are dementias that fall under this category behavioral manifestations of the dementia diagnoses, including are ‘‘most commonly a secondary underlying condition. These dementia Alzheimer’s Disease, Lewy-Body manifestation of an underlying causal conditions and ICD–9–CM codes are too Dementia, fronto-temporal dementia, condition.’’ numerous to list within the context of and senile degeneration of the brain, to the proposed and final rules but are Two of the most frequently reported name a few, that are allowable as found in the ICD–9–CM Official dementia codes on hospice claims fall principal diagnoses per ICD–9–CM Guidelines for Coding and Reporting under this manifestation/etiology Coding Guidelines and are located manual. However, we clarified that convention: ‘‘dementia in conditions under the classification of ‘‘Diseases of dementia codes can be found under two classified elsewhere with behavioral the Nervous System and Sense Organs’’ classifications in the ICD–9–CM Official disturbance’’ and ‘‘dementia in in the ICD–9–CM Official Guidelines for Guidelines for Coding and Reporting, conditions classified elsewhere without Coding and Reporting manual. ‘‘Mental, Behavioral and behavioral disturbance’’. Per ICD–9–CM Some of the ICD–9–CM dementia Neurodevelopmental Disorders’’ and Coding Guidelines, these codes are not diagnoses take into account that some ‘‘Diseases of the Nervous System and acceptable as a reported principal dementia conditions may be unspecified Sense Organs.’’ Per ICD–9–CM Coding diagnosis, and the underlying physical in the event that a definitive diagnostic Guidelines, several, but not all, of these condition must be coded first. These work-up was not or could not be ICD–9–CM dementia codes are codes can be used as additional or other performed. However, based on the considered manifestation codes, diagnoses on the hospice claim. present and historical clinical especially those dementia codes Additionally, two other frequently presentation of the individual, there are classified under ‘‘Mental, Behavioral reported dementia codes on hospice unspecified dementia diagnoses and and Neurodevelopmental Disorders’’. In claims have underlying disease-specific corresponding ICD–9–CM codes that are accordance with the 2012 ICD–9–CM sequencing conventions: ‘‘senile acceptable as a principal diagnosis per Coding Guidelines, ‘‘certain conditions dementia, uncomplicated’’ and ‘‘other ICD–9–CM Coding Guidelines. Most of have both an underlying etiology and persistent mental disorders due to these codes can be found under the multiple body system manifestations conditions classified elsewhere’’. There classification, ‘‘Diseases of the Nervous due to the underlying etiology. For such are ICD–9–CM Coding Guidelines System and Sense Organs.’’ However, conditions, the ICD–9–CM has a coding specific to each of these codes and these the expectation remains that the convention that requires the underlying codes cannot be used as the principal certifying physician will select the condition be sequenced first followed diagnosis but can be reported as appropriate diagnoses and codes that by the manifestation. Wherever such a additional or other diagnoses on the determine the terminal prognosis of the

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individual and that are most However, in the FY 2014 hospice wage plan of care. Our regulations at contributory to the terminal decline. index and payment rate update § 418.200, hospices must provide all proposed rule, we presented data services reasonable and necessary for 4. Guidance on Coding of Principal and analysis where the principal hospital the palliation and management of the Other, Additional, and/or Co-existing diagnosis was a cancer diagnosis, but terminal illness and related conditions. Diagnoses the hospice diagnosis was not. It would As noted, we require hospices to In the FY 2014 Hospice Wage Index be expected that, in a cancer diagnosis, provide virtually all the care that is and Payment Rate Update proposed in which the individual received needed by terminally ill patients. rule, we stated based on the ICD–9–CM inpatient medical care for that diagnosis Therefore, unless there is clear evidence Coding Guidelines, that the and was discharged home with hospice that a condition is unrelated to the circumstances of an inpatient admission election within three days, that the terminal prognosis, all services would always govern the selection of principal principal hospice diagnosis would be be considered related. It is also the diagnosis (78 FR 27833). The principal the inpatient hospital diagnosis of responsibility of the hospice physician diagnosis is defined in the Uniform cancer. However, to clarify, we are not to document why a patient’s medical Hospital Discharge Data Set (UHDDS) as requiring that the principal hospice need(s) would be unrelated to the ‘‘that condition established after study diagnosis always must be the exactly the terminal prognosis. We expect that to be chiefly responsible for occasioning same as the inpatient hospital diagnosis. hospice providers will use their best the admission of the patient to the We continue to reiterate that the clinical judgment in determining which hospital for care.’’ In analyzing certifying physician, using his or her diagnoses and conditions are related to frequently reported principal hospice expert clinical judgment and supporting the terminal prognosis of the individual diagnoses, data analysis revealed documentation from the clinical records receiving hospice care and will report differences between reported principal and the comprehensive assessment(s), those diagnoses and conditions hospice diagnoses and reported will determine the most appropriate accordingly on the hospice claims. principal hospital diagnoses in patients principal diagnosis, along with other, In response to the comment regarding who elected hospice within 3 days of additional related diagnoses, that are the diagnosis not being available at the discharge from the hospital. In addition, contributing to the terminal prognosis of time of referral, we understand that a in the proposed rule we stated that our the individual. Our purpose in diagnosis may not be provided at the expectation is for hospice providers to providing these statements in the time of hospice referral given the report all coexisting or additional proposed rule was to remind providers sometimes acute nature of a hospice diagnosis related to the terminal of the ICD–9–CM Coding Guidelines referral. However, upon the hospice prognosis and related conditions. which state, to list first the diagnosis physician’s review of the Comment: Several commenters said shown in the medical record to be comprehensive assessment along with that these statements could be chiefly responsible for the services the other clinical records, the interpreted to mean that the principal provided and to list additional codes expectation is that a diagnosis for hospice diagnosis must always mirror that describe any coexisting conditions. hospice claims coding should be the hospital diagnosis and while this is Comment: One commenter questioned determined based on this review along often the case, there are sometimes what the expectation is for the number with the hospice physician’s best specific clinical scenarios in which this of other, additional diagnoses that clinical judgment as to the condition would not necessarily occur. The should be reported on the hospice most contributory to the terminal commenters requested further claim. This commenter stated that it was prognosis. clarification so that hospice providers not the hospice’s standard to report Furthermore, the expectation is to do not feel compelled to violate their diagnoses not related to the terminal provide the diagnostic codes on the own coding judgment just to replicate prognosis on the hospice claim. Another claim to reflect the individual’s clinical the inpatient hospital diagnoses based commenter stated that hospice status regardless of the number of on ‘‘mandates’’ from CMS. providers historically were ‘‘cautioned diagnoses to do so. There are an ample Response: In our statements regarding for potential enticement by covering too number of diagnosis fields on the the guidelines governing the selection of many diagnoses.’’ A few commenters hospice claims for reporting. Because the principal hospice diagnosis, they expressed concern about how CMS may the hospice reimbursement is a bundled were made to provide additional use additional information of the per diem rate, there is no enticement for guidance on the selection of the secondary and tertiary diagnoses for reporting too many. The goal of principal diagnosis for hospice complex patients. requesting all of the related diagnoses providers based on the ICD–9–CM Response: We do not require on the hospice claim is to have a more Coding Guidelines. We recognize that hospice’s to report a specific number of accurate picture of the Medicare hospice the principal hospice diagnosis may not diagnoses on the hospice claims. beneficiary population. This accurate mirror the inpatient hospital diagnosis However, ICD–9–CM Coding Guidelines picture of the Medicare hospice in certain circumstances. The scenario are specific in its instructions to population will also help to ensure that below, provided by a commenter, is an providers to ‘‘code all documented any payment reform model that is example: conditions at the time of the encounter/ considered is done so in a responsible visit, and require or affect patient care A patient was admitted to the hospital with and thoughtful manner to protect the a diagnosis of pneumonia. Upon diagnostic treatment or management.’’ Therefore, viability, integrity, and intent of the work-up, it was discovered that the patient we expect that hospice providers will Medicare Hospice Benefit and the care had stage 4 lung cancer. The patient opted adhere to these guidelines in reporting philosophy of the hospice industry. not to pursue curative treatment and was the appropriate diagnoses to more fully discharged to home with hospice services in describe the Medicare hospice 5. Transition to ICD–10–CM place. The principal hospice diagnosis beneficiaries receiving care and services In the FY 2014 Hospice Wage Index selected for this patient was lung cancer. needed to palliate and manage their and Payment Rate Update proposed rule This would be an appropriate principal terminal conditions, based on the we reminded hospice providers of the hospice diagnosis, though it was not the information from the comprehensive upcoming transition from ICD–9–CM to same as the primary hospital diagnosis. assessment and individualized hospice ICD–10–CM on October 1, 2014. We

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provided additional information B. The Hospice Quality Reporting measures for the HQRP that promote regarding the transition to ICD–10–CM Program efficient and safer care. Our measure selection activities for the HQRP takes that is available through the CMS Web 1. Background and Statutory Authority site at: http://www.cms.gov/Medicare/ into consideration input we receive Coding/ICD10/index.html?redirect=/ Section 3004 of the Affordable Care from the Measure Applications icd10; and ICD–10–CM coding Act amended the Act to authorize a Partnership (MAP), convened by the quality reporting program for hospices. guidelines can be found on the CDC’s National Quality Forum (NQF), as part Section 1814(i)(5)(A)(i) of the Act Web site at www.cdc.gov/nchs/data/ of a pre-rulemaking process that we requires that beginning with FY 2014 icd10/10cmguidelines2012.pdf. have established and are required to and each subsequent FY, the Secretary follow under section 1890A of the Act. Comment: We received multiple shall reduce the market basket update The MAP is a public-private partnership comments asking to suspend the by 2 percentage points for any hospice comprised of multi-stakeholder groups enforcement of the clarifications of ICD– that does not comply with the quality convened by the NQF for the primary 9–CM Coding Guidelines until the data submission requirements with purpose of providing input to CMS on implementation of ICD–10–CM. It was respect to that FY. Depending on the the selection of certain categories of stated that the preparation for the amount of the annual update for a quality and efficiency measures, as transition to ICD–10–CM was particular year, a reduction of 2 required by section 1890A(a)(3) of the burdensome enough for hospice percentage points could result in the Act. By February 1st of each year, the providers. annual market basket update being less NQF must provide that input to CMS. than 0.0 percent for a FY and may result Input from the MAP is located at: Response: The transition to ICD–10– in payment rates that are less than (http://www.qualityforum.org/Setting_ CM has been discussed in previous payment rates for the preceding FY. Any Priorities/Partnership/Measure_ hospice rules and notices, and the reduction based on failure to comply Applications_Partnership.aspx). For transition deadline for ICD–10–CM has with the reporting requirements, as more details about the pre-rulemaking already been pushed back until its required by section 1814(i)(5)(B) of the process, see the FY 2013 IPPS/LTCH current October 1, 2014 implementation Act, would apply only for the particular PPS final rule (77 FR at 53376 (August date to allow for providers to have FY involved. Any such reduction will 31, 2012)). adequate time to prepare their not be cumulative and will not be taken We also take into account national administrative processes and systems. into account in computing the payment priorities, such as those established by Additionally, in our regulations at 45 amount for subsequent FYs. the National Priorities Partnership at CFR 162.1002, the Secretary adopted the Section 1814(i)(5)(C) of the Act (http://www.qualityforum.org/npp/), the ICD–9–CM code set, including The requires that each hospice submit data HHS Strategic Plan http://www.hhs.gov/ Official ICD–9–CM Guidelines for to the Secretary on quality measures secretary/about/priorities/ Coding and Reporting. The CMS’ specified by the Secretary. The data priorities.html), and the National Hospice Claims Processing manual (Pub must be submitted in a form, manner, Strategy for Quality Improvement in and at a time specified by the Secretary. 100–04, chapter 11) requires that Healthcare located at (http:// Any measures selected by the Secretary hospice claims include other diagnoses www.healthcare.gov/news/reports/ must have been endorsed by the ‘‘as required by ICD–9–CM Coding nationalqualitystrategy032011.pdf). To consensus-based entity which holds a Guidelines’’. Furthermore, these ICD–9– the extent practicable, we have sought contract regarding performance to adopt measures that have been CM Coding Guidelines have been measurement with the Secretary under endorsed by the national consensus existing and longstanding policies that section 1890(a) of the Act. This contract organization, recommended by multi- should be adhered to by all providers. is currently held by the NQF. However, stakeholder organizations, and Other health care providers in both section 1814(i)(5)(D)(ii) of the Act developed with the input of providers, the inpatient and outpatient settings are provides that in the case of a specified purchasers/payers, and other required to follow these coding area or medical topic determined stakeholders. guidelines, and enforcement of these appropriate by the Secretary for which As stated in the August 4, 2011 FY policies has been part of their payment a feasible and practical measure has not 2012 Hospice Wage Index final rule (76 systems for years. The expectation for been endorsed by the consensus-based FR 47302, 47320), to meet the quality hospice providers to follow those same entity, the Secretary may specify reporting requirements for hospices for guidelines is imperative to ensure measures that are not so endorsed as the FY 2014 payment determination as continuity and quality of care long as due consideration is given to set forth in section 1814(i)(5) of the Act, throughout a Medicare beneficiary’s measures that have been endorsed or we finalized the requirement that hospices report two measures: health care continuum. Therefore, we adopted by a consensus-based organization identified by the Secretary. • An NQF-endorsed measure that is stand by our clarifications regarding the Section 1814(i)(5)(D)(iii) of the Act related to pain management, NQF ICD–9–CM Coding Guidelines and ICD– requires that the Secretary publish #0209. The data collection period for 10–CM Coding Guidelines. However, in selected measures applicable with this measure was October 1, 2012 response to the comments received respect to FY 2014 no later than October through December 31, 2012, and the regarding the additional time needed to 1, 2012. data submission deadline was April 1, implement these coding clarification 2013. The data for this measure are changes within their software systems, 2. Quality Measures for Hospice Quality collected at the patient level, but are we will require these coding changes Reporting Program and Data Submission reported to CMS in the aggregate for all beginning on October 1, 2014, when all Requirements for Payment Year FY 2014 patients cared for within the reporting hospice claims submitted on or after The successful development of a period, regardless of payer. October 1, 2014 will be subject to Hospice Quality Reporting Program • A structural measure that is not having claims returned if presented for (HQRP) that promotes the delivery of endorsed by NQF: Participation in a payment with incorrect codes. high quality healthcare services is our Quality Assessment and Performance paramount concern. We seek to adopt Improvement (QAPI) program that

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includes at least three quality indicators payment determination. The original structural measure requirement, not the related to patient care. The data intent of the structural measure was for QAPI program requirement from the collection period for this measure was hospices to submit information about Conditions of Participation. October 1, 2012 through December 31, number, type, and data source of quality Response: The results of the voluntary 2012, and the data submission deadline indicators used as a part of their QAPI reporting period and the analysis of the was January 31, 2013. Hospices are not Program. Data gathered as part of the FY 2014 structural measure data asked to report their level of structural measure were used to provided adequate information about performance on these patient care ascertain the breadth and context of hospices’ patient care-related quality related indicators, but simply to existing hospice QAPI programs to indicators. We are finalizing the indicate that a QAPI program with inform future measure development proposal to remove the structural patient care related indicators has been activities including the data collection measure requirement beyond data implemented. approach for the first year of required submission for the FY 2015 payment Hospices failing to report quality data reporting (the reporting period which determination. We are reiterating that before the specified deadline in 2013, could result in payment reductions in the requirements regarding QAPI in the will have their market basket update FY 2014). To date, hospices have Conditions of Participation remain reduced by 2 percentage points in FY reported two cycles worth of structural intact. 2014. Hospice programs will be measure data to CMS: As stated above, in the proposed rule, evaluated for purposes of the quality • Voluntary reporting period we proposed that the NQF #0209 pain reporting program based on whether or (submitted to CMS by January 31, measure not be required for the hospice not they submit data, and not based on 2012)—For the voluntary reporting quality reporting program beyond data their performance level on required period hospices submitted free text data submission for the FY2015 payment measures. describing each quality indicator in determination. We determined that the For the FY 2014 payment their QAPI programs; data regarding NQF #0209 measure as it is currently determination, hospices were asked to number and data source of quality collected and reported by hospices is provide identifying information, and indicators were also submitted. not suitable for long term use as part of then complete a web based data entry • FY 2014 (submitted to CMS by the Hospice Quality Reporting Program for the required measures. For hospices January 31, 2013)—For the FY 2014 (HQRP). In making this decision, we that could not complete the web based cycle, hospices submitted data about the considered findings from the Voluntary data entry, a downloadable data entry topic areas of care addressed by quality Reporting Period and the Hospice Item form was made available upon request. indicators in their QAPI Programs, using Set pilot. Since the publication of the Electronic data submission will be a drop-down menu checklist rather than proposed rule, we examined data from required for the FY 2015 payment free text, in order to reduce burden. Data the first year of reporting on the determination and beyond; there will be regarding number and data source of measure (impacting FY 2014 APU no other data submission method quality indicators were also submitted. determination). In addition, we available. CMS has analyzed data from both considered stakeholder input including reporting periods. Findings from the comments submitted during 3. Quality Measures for Hospice Quality voluntary reporting period showed that rulemaking, expert input from a Reporting Program and Data Submission hospices use quality indicators that Technical Expert Panel (TEP), and Requirements for Payment Year FY 2015 address a wide range of patient care provider questions and comments and Beyond related topics and that there is great submitted to the hospice quality help In the November 8, 2012 CY 2013 variation in how hospices collect and desk during the 2012/2013 data Home Health Prospective Payment use ‘‘standardized’’ quality indicators. collection and reporting period. There System Rate Update final rule (77 FR The majority of reported indicators are two central concerns with the NQF 67068, 67133), to meet the quality addressed patient safety and physical #0209 measure. First, the measure does reporting requirements for hospices for symptom management. Likewise, not easily correspond with the clinical the FY 2015 payment determination and findings from analysis of the FY 2014 processes for pain management, each subsequent year, as set forth in structural measure data reiterated resulting in variance in what hospices section 1814(i)(5) of the Act, we findings from the voluntary reporting collect, aggregate, and report. This finalized the requirement that hospices period. concern could potentially be addressed report two measures: Other topics addressed included by extensive and ongoing provider • The NQF-endorsed measure that is management of psychosocial aspects of training or standardizing data related to pain management, NQF #0209 care, bereavement and grief, collection. However, even with • The structural measure: communication, and care coordination. extensive training and the use of a Participation in a Quality Assessment Overall, findings from both data standardized item set during the pilot and Performance Improvement (QAPI) collections of the structural measure test, the data showed continued Program that includes at least three have provided adequate information on variance in implementation of the quality indicators related to patient care. hospice’s patient care-related indicators measure. Second, there is a high rate of We did not extend the requirement that making further reporting on the patient exclusion due to patient hospices complete a check list of their structural measure unnecessary. ineligibility for the measure and patient care indicators and indicate the Comment: We received several patients’ denying pain at the initial data sources they used for their quality comments in favor of the proposal to assessment. This high rate of patient indicators. remove the structural measure exclusion from the measure results in a In the proposed rule for FY2014 (78 requirement beyond data submission for small denominator and creates validity FR 27823), we proposed that the the FY 2015 payment determination. concerns. These concerns cannot be structural measure related to QAPI There were no comments in opposition addressed by training or standardizing indicators and the NQF #0209 pain to removing the structural measure data collection. We recognize the value measure would not be required for the requirement after FY 2015. One of measuring hospices’ ability to achieve hospice quality reporting program commenter indicated that CMS should patient comfort and the desire to beyond data submission for the FY 2015 make clear that it was only removing the include a patient outcome measure such

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as the NQF #0209 in the HQRP. By commenters indicated that the NQF efforts. However, we believe that removing the requirement that hospices #0209 should be retained. Commenters continuing to require hospices to report submit the NQF #0209 measure, pain in favor of retaining the measure stated the NQF #0209 measure beyond FY comfort will not be measured as part of that, though flawed, the measure has 2015 is inappropriate and burdensome. the HQRP. However, we plan to require merit because it is an outcome measure. We agree that outcome measures are that hospices collect data on two other They also felt it has merit because it essential to the HQRP. We are measures that address care for pain. The incorporates patient preferences for pain committed to developing an improved standardized item set that CMS has management and is meaningful to pain outcome measure and we will developed contains data elements to consumers. Commenters also stated that work toward the HQRP’s future collect 7 quality measures endorsed by hospices invested a lot of time and inclusion of an improved pain outcome NQF for hospice. Among these are two energy to establish their data collection measure. Although we appreciate the process measures related to pain: the and submission processes for this value of including an outcome measure NQF #1634, Pain Screening, and NQF measure. One commenter thought CMS as part of the HQRP, based on the #1637, Pain Assessment. However, should evaluate additional quarters of majority of comments received and FY while these measures provide insight data submissions by hospices to fully 2014 NQF #0209 data analysis findings, about screening and assessment of evaluate the measure’s validity before we are finalizing the proposal to patients, they do not offer information deciding whether to eliminate its use discontinue use of the NQF #0209 pain about patient-reported comfort related from the HQRP. measure after FY 2015 reporting. We to pain. Response: Since the release of the will not finalize the alternate proposal In the proposed rule, an alternative proposed rule, we have analyzed the to retain the NQF #0209 until another proposal was made to retain NQF #0209 NQF #0209 pain measure data from the pain outcome measure is available. until a more suitable outcome measure FY 2014 hospice reporting cycle. was available for use in the HQRP, to 4. Quality Measures for Hospice Quality Results from the analysis support our maintain a focus on achieving patient Reporting Program for Payment Year FY central concerns with the NQF #0209 comfort. We also recognize the 2016 and Beyond pain measure as stated above. Due to importance of adherence to As stated in the November 8, 2012 CY exclusions, a very small percentage of standardized data collection 2013 Home Health Prospective Payment patients admitted to hospice would be specifications when producing System Rate Update final rule (77 FR represented by this quality measure, measures for public reporting. We 67068, 67133), we considered an intend to work toward the HQRP’s suggesting validity issues with the expansion of the required measures to future inclusion of an improved pain measure. FY 2014 data analysis shows include additional measures endorsed outcome measure. We solicited that data errors affected approximately by NQF. We also stated that to support comment on the removal of the one-third of all hospices’ data the standardized collection and checklist and data source questions submissions despite the use of warning calculation of quality measures, from the structural measure, and the and error messages in the data collection of the needed data elements removal of the NQF #0209 measure. We submission system. In addition, the data will require a standardized data also solicited comment on the showed that approximately 30 percent collection instrument. We have alternative proposal of maintaining NQF of the patients who were asked the developed and tested a hospice patient- #0209 until another pain outcome initial comfort question ended up in the level item set to be used by all hospices measure is available. measure denominator (the denominator to collect and submit standardized data Comment: A large majority of is set by patients who said ‘‘yes’’ to the items about each patient admitted to comments received agreed with the initial comfort question). The data also hospice. We contracted with RTI proposal to remove the NQF #0209 pain showed that approximately 54 percent International to support the measure from the HQRP because of the of hospices had 10 or fewer admissions development of the Hospice Item Set concerns with the measure as described during the data collection period (Q4 (HIS) for use as part of the HQRP. In above. Commenters stated that the 2012), indicating a denominator size developing the HIS, RTI focused on the measure is difficult to implement and problem that would affect the potential NQF endorsed measures that had does not correspond with clinical use of the measure for public reporting evidence of use and/or testing with processes for pain management. One purposes in the future. We will post a hospice providers. Most of these commenter suggested that there is not document summarizing the findings measures were initially developed an issue with the data collection not related to the NQF #0209 measure on during the PEACE (Prepare, Embrace, corresponding to hospice clinical the cms.gov Web site at http:// Attend, Communicate, and Empower) practice, but rather a learning curve www.cms.gov/Medicare/Quality- Project, which was funded by CMS to phenomenon. Commenters also agreed Initiatives-Patient-Assessment- develop and test an initial set of quality that high rates of patient exclusion from Instruments/Hospice-Quality-Reporting/ measures for use in hospice and the measure lead to validity issues. The index.html. The document includes palliative care. The PEACE project, majority of commenters were also findings from the Voluntary Reporting which ended in 2008, resulted in the against the alternate proposal to retain Period, the Hospice Item Set Pilot Test, identification of recommended quality the NQF #0209 until an alternate pain and the FY 2014 national reporting of measure and data collection tools that outcome measure is developed, citing the NQF #0209 data. These three hospice providers could use in their that continuing to collect it would be an sources of information along with Quality Assessment and Performance unnecessary burden on providers. Some stakeholder comments during the public Improvement (QAPI) programs to assess also commented that discontinuing data comment period were considered in quality of care and target areas for collection for the NQF #0209 pain finalizing the proposal to discontinue improvement. Additional information measure after the CY 2013 data the requirement that hospices report the on the PEACE project can be found at collection period would permit hospices NQF #0209 measure beyond FY 2015. http://www.thecarolinascenter.org/ more time to focus on preparing for the We understand that hospices may default.aspx?pageid=24. implementation of the Hospice Item Set choose to use the NQF #0209 as part of Most of the measures endorsed by (HIS) and other requirements. A few their ongoing quality improvement NQF are already widely in use by

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hospices nationwide as part of their 2016 payment determination and each they are posted. We encourage vendors internal Quality Reporting and subsequent year, we proposed regular to submit questions and comments to Performance Improvement (QAPI) and ongoing electronic submission of the HIS technical email box: programs. Data we received from the HIS data for each patient admitted [email protected]. hospices during the Voluntary to hospice on or after July 1, 2014, On July 16, 2013, CMS held a call Reporting Period in 2011 showed that regardless of payer. Hospices will be specific for software developers and hospices had implemented and were required to complete and submit an vendors regarding the HIS technical using the PEACE measures. Some of the admission HIS and a discharge HIS for data specifications. We will hold PEACE measures were endorsed by NQF each patient. Hospices failing to report additional vendor calls as needed to in February, 2012, and are listed below quality data via the HIS in 2014 will ensure that software vendors have the with their NQF endorsement numbers. have their market basket update reduced appropriate information to develop their The HIS standardizes the collection of by 2 percentage points in FY 2016. own products for HIS. Software vendors the data elements that are needed to Hospice programs will be evaluated for should not be waiting for final technical calculate seven of the NQF endorsed purposes of the quality reporting data specifications to be posted to begin measures. The HIS was pilot tested program based on whether or not they development of their own products. during the early summer of 2012. The submit data, not on their performance Therefore, we believe that vendors have primary objective of the pilot was to level on required measures. been provided with adequate time and explore data collection methods and the Comment: We received comments resources to meet the July 1, 2014 feasibility of implementing a patient- that were supportive of the implementation date of the HIS. level item set for possible future use as implementation of the Hospice Item Set CMS will provide free software for the part of the HQRP. (HIS). Commenters agreed with the need HIS. We will make a beta version of the In developing the standardized HIS, for a standardized item set to collect software available in May 2014 and the we considered comments offered in patient level information that could be final version in June 2014. Providing a response to the July 13, 2012 CY 2013 used to calculate the quality measures beta version for hospice agencies to Home Health Prospective Payment endorsed by the National Quality Forum download in May will allow their staff System Rate Update proposed rule (77 (NQF) for hospice. However, to become familiar with the FR 41548, 41573). We have included commenters were concerned that the functionality of the tool. We will data items that support the following proposed July 1, 2014 date for starting provide training on the CMS HIS NQF endorsed measures for hospice: submission of the HIS was too soon, and software and the submission process. • didn’t allow for adequate time to We anticipate the training to occur in NQF #1617 Patients Treated with an prepare processes and systems for data Opioid who are Given a Bowel the spring of 2014. Furthermore, in collection, staff training, and other cases where a hospice has purchased Regimen organizational preparations for • vendor software and the product is not NQF #1634 Pain Screening implementation, particularly in the • available by July 1, 2014, the hospice NQF #1637 Pain Assessment context of the other proposals in the • may download the CMS software and NQF #1638 Dyspnea Treatment rule such as the implementation of the • submit records to the Quality NQF #1639 Dyspnea Screening hospice experience of care instrument. • Improvement and Evaluation System NQF #1641 Treatment Preferences Commenters noted that vendors would • (QIES) Assessment and Submission NQF #1647 Beliefs/Values have less than 12 months to create Processing (ASAP) system as required. Addressed (if desired by the patient) software for providers to use to submit Thus, hospices will be able to comply (modified) the HIS data. Commenters were with the July 1, 2014 implementation To achieve a comprehensive set of concerned that there were too many hospice quality measures available for changes coming in too short a time. date of the HIS. We are finalizing widespread use for quality improvement Response: We appreciate the general implementation of the HIS on July 1, and informed decision making, and to support of standardized data collection 2014. carry out our commitment to develop a and the Hospice Item Set (HIS). We are Comment: Several commenters quality reporting program for hospices aware of the effort hospices and vendors expressed concern over the ‘‘100 that uses standardized methods to will have to make to prepare for percent submission requirement’’ of the collect data needed to calculate quality implementation of the HIS. The HIS HIS and stated that exceptions for measures, we proposed the pilot showed that implementing the HIS natural disasters and other extenuating implementation of the HIS in July 2014. is feasible, and that hospices are most circumstances should be allowed. In We believe that to support the likely already collecting the information addition, a few commenters expressed standardized collection and calculation needed to complete the HIS data items. concern that a hospice would be of any or all of the hospice quality A draft version of the HIS technical data penalized if even one submission was measures listed above, it is necessary to specifications was posted on the CMS missed, and that there needs to be a use a standardized data collection Web site on May 24, 2013. Based on receipt process that would provide mechanism. The HIS was developed other provider settings (for example, proof of data submission. specifically for this data collection Home Health Agencies and Nursing Response: Submission of the HIS on purpose. The HIS Paperwork Reduction Homes), it is our experience that when all patients admitted to hospice, Act (PRA) package is posted on the PRA there are changes to the draft version of regardless of payer, is expected. As is area of the CMS.gov Web site at: data specification the changes are minor common in other quality reporting https://www.cms.gov/Regulations-and- and few, if any, compared to the final programs, we will propose to make Guidance/Legislation/ version of the technical data accommodations in the case of natural PaperworkReductionActof1995/ specifications. Thus, vendors have been disaster or other extenuating index.html. provided with more than adequate time circumstances in next year’s We proposed that hospices begin the (greater than 12 months) to develop rulemaking. In addition, the data use and submission of the HIS in July products for their clients. We expect submission system will include 2014. To meet the quality reporting vendors to begin reviewing the draft validation and receipt processes that requirements for hospices for the FY technical data specifications as soon as will serve as evidence of submission.

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Comment: Some commenters were able to crosswalk items from their necessary to generate the denominator indicated that they support the patient assessment forms to the HIS data for NQF #1637. implementation of the HIS and the elements, and complete the HIS items. Comment: Two comments stated that endorsed measures that can be Therefore, the HIS did not add items to items for the NQF #1641 and #1647 calculated from the items on the HIS. the hospice’s customary patient initial should appear on the discharge HIS to However, while overall supportive of assessment, and did not present an meet measure specifications. the measures and the HIS, they also additional burden to the patient and/or Response: The NQF #1641 measure indicated concern about the length of family or caregivers. endorsement form does not specify a stay exclusion in the endorsed measures Comment: A few commenters time window for the measure that will be calculated from the HIS. suggested removing the discharge HIS, numerator. The commenters are correct Commenters were also concerned that indicating that the items on the that the NQF #1647 measure there were no outcome measures that discharge HIS are only administrative, endorsement form does specify that the will be calculated from the HIS. We also and provide no additional value in numerator criteria can be met any time received a few comments indicating terms of the quality measures while during the period the patient is enrolled concern over other measure adding burden of completion to the in the hospice program. We have specifications (for example, additional hospice. Other commenters indicated consulted NQF about our proposal to exclusions for measures). that they were pleased to see the capture the data on the admission HIS, Response: To comply with the proposal of an admission and discharge and have received guidance that by requirements of the Affordable Care Act, HIS. limiting the time window in this way, CMS seeks to implement meaningful Response: The discharge HIS is we are proposing to use a ‘‘modification quality measures with demonstrated needed to provide an end date for the of the NQF #1647’’ measure. We have scientific acceptability that have been episode of care, and to establish the opted to include the relevant items for endorsed by an endorsing body, length of stay exclusion for patients both the NQF #1641 and the NQF #1647 currently the NQF. Thus, we are whose hospice stay was less than 7 on the Admission HIS, even though the somewhat, but not completely days. The discharge HIS items are measure specifications for the NQF constrained by the availability of minimal, but necessary for accurate #1647 permit the numerator condition endorsed hospice quality measures. In records in the CMS data system and to be met at any time during the hospice addition, in selecting and implementing potentially for the providers’ use with episode of care. For multiple reasons, measures, we are constrained by the their own QAPI activities. Vendor CMS has opted to include the NQF measures specifications of the endorsed software would pre-populate the #1647 measure items as part of the measures. All of the measures that will majority of these items and the hospice Admission HIS, reflecting the initial be implemented are endorsed with a 7- would only code a few of the items on period of time the patient is in hospice day length of stay exclusion as part of the discharge HIS; burden on hospices care. Addressing patients’ values/beliefs the measure specifications. Section would be reduced as a result. and preferences for treatment by 1841(i)(5)(D) of the Act requires us to be Comment: A few commenters voiced providing an opportunity for patients deferential to measures approved by an concerns about potential ceiling effects and families to discuss their preferences endorsing body such as the NQF. with the NQF quality measures stating during the comprehensive assessment However, we agree that the length of that measures may ‘‘top out.’’ Two period is an important step in ensuring stay exclusion in particular is of commenters stated that NQF #1634 Pain the delivery of hospice care that is concern because it effectively excludes Screening should not be considered for patient and family-centered. Including an important segment of hospice use in the quality reporting program, the NQF #1647 measure items as part of patients from the measures. We plan to citing concerns about ceiling effects the Admission HIS also aligns with the analyze HIS data to continue to assess with the measure. Conditions of Participation for hospices the scientific acceptability of the Response: We recognize the at § 418.54(c), which state that the measures and are willing to work with commenters’ concerns about the comprehensive assessment ‘‘must measure developers and stewards to appropriateness of use of quality identify the physical, psychosocial, make modifications to measures where measures that have ‘‘topped out,’’ emotional and spiritual needs related to needed. In addition, we support the demonstrating ceiling effects. Ceiling the terminal illness that must be development of additional hospice effects on quality measures would addressed in order to promote the quality measures, particularly outcome indicate that there is little room for hospice patient’s well-being, comfort, measures, and will seek opportunities to improvement on the particular quality and dignity throughout the dying use outcome measures as they are measures across providers, rendering process. . . .’’ We recognize that the developed and validated. the measures of little use in measuring discussion can take place at any time in Comment: We received a few quality. There is currently no national the course of a patient’s hospice care but comments indicating concern over the data available to determine whether any believe the patient should be offered the potential burden of the HIS on patients of the proposed measures demonstrate opportunity to address these concerns and families. ceiling effects. We will analyze data in the early days of care when they are Response: The HIS is a set of data submitted to determine validity and more likely to be able to do so. We elements that can be used to calculate reliability of measures, and part of this consider it best practice. We have 7 NQF endorsed quality measures. The analysis will include analyzing for chosen this approach also because it HIS is not a patient assessment and it ceiling effects. We will determine allows the gathering of the data for the will not be administered to the patient appropriateness of measures for measure closer to ‘‘real time’’ in terms and/or family or caregivers during the retention in the quality reporting of usual hospice assessment and initial assessment visit. The HIS is not program based on these analyses. We workflow and because this approach intended to replace a hospice’s current appreciate commenters’ concerns about will likely improve accuracy and reduce initial patient assessment. The HIS pilot NQF #1634 Pain Screening. However, burden to the provider. If these items demonstrated that hospices use a variety NQF #1634 Pain Screening and NQF were on the discharge HIS, hospices of patient assessment forms during the #1637 Pain Assessment are paired would have to review the entire episode initial patient assessment; all hospices measures meaning NQF #1634 is of care documentation to find the

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information needed to complete the social worker or bereavement staff patients. We believe that this item is relevant items on the HIS. We worked member could collect the data or if it important for measure maintenance and with the measure developer to ensure had to be a chaplain. development. The HIS applies to all that the intent of the measure is still met Response: The measure specifications payers, which is why CMS is not relying with the HIS admission data collection. for NQF #1647 require documentation on claims or other available data We will monitor the performance over of a discussion between the patient and/ sources. To limit the burden on hospice time to inform future evaluation for or family and a member of the providers we chose to limit the maintenance of the measure’s interdisciplinary team or clergy or diagnostic categories. endorsement. We will proceed with the pastoral worker, or documentation that Comment: We received comments collection of the NQF #1641 measure the patient/family declined to discuss. that J0900 (Pain Screening) and J0910 and the modified NQF #1647 measure We will provide guidance and training (Comprehensive Pain Assessment) went as part of the Admission HIS. materials, including a detailed user beyond the measures specifications for Comment: We received a few guide, to hospices prior to NQF #1634 and NQF #1637. Some comments regarding what should count implementation of the HIS. commenters did not understand the towards the numerator for NQF #1641 Comment: We received comments purpose of J0900D (the patient’s pain (Treatment Preferences). Commenters providing input about specific items on severity rating); others argued that suggested that review of advance the HIS. Commenters offered J0900D should be removed from the directives count in the numerator for suggestions on items in Sections A, F, item set because it incorrectly implies these items. I, J, N, and Z of the HIS. that a clinician’s opinion of pain Response: Discussion of patient Response: We appreciate the severity is an acceptable datum. Others preferences is important to ensure that comments received about specific items questioned the inclusion of J0910C care is individualized, patient and in the HIS. The items in Section A are (Comprehensive Pain Assessment family centered, and consistent with a subset of those that appear and are included). patient and/or family preferences. The standardized across data submission Response: The NQF # 1634 and 1637 intent of the NQF #1641 measure is to vehicles in multiple CMS quality are ‘‘paired measures’’. The NQF #1634 ensure that hospices engage patients reporting programs; they are needed for forms the denominator for the NQF and families in opportunities to discuss adequate record identification in CMS #1637 measure. The measure their treatment preferences. Hospices systems. Items in Sections F, I, J, and N specifications for NQF #1634 require meet the #1641 numerator requirements are all necessary to establish the that patients must be screened for the by asking the patient and/or family numerator and/or denominator; meet presence or absence of pain (and if about their preferences and other measure specifications for the 7 present, a rating of its severity) using a documenting that a discussion of NQF endorsed measures that can be standardized tool. The measure preferences occurred, or by calculated from the HIS; or for purposes specifications do not require hospices to documenting that the patient and/or of future potential risk adjustment to the use one particular tool or clinical family did not wish to discuss their measures. approach, in recognition of prior preferences. The measure endorsement Comment: We received several stakeholder input that indicated it is forms clearly state that the measure is comments regarding who the hospice important to allow clinicians to select meant to capture evidence of must speak with about items in Section and use the appropriate screening tool communication and discussion. Prior to F (Preferences) to meet the numerator on a case-by-case basis. The HIS is not implementation of the HIS, we will condition for the corresponding a patient assessment; it is an item set provide hospices with guidance and measures. A few commenters noted that designed to collect data elements that training materials, including a detailed not all patients have caregivers. can be used to calculate NQF endorsed user guide. Response: For items F2000, F2100, measures, including NQF #1634 and Comment: We received a comment and F2200, the hospice must ask the #1637. As a result, item J0900D is that NQF #1641 (Treatment Preferences) patient or the patient’s representative if needed to establish whether or not the does not mention cardiopulmonary the patient is unable to self-report. The standardized screening tool selected and resuscitation (CPR) or hospitalization. responsible party may or may not be a used by the clinician indicated that the Response: The measure specifications family member or caregiver. We will patient had pain. Details of how to code as endorsed by NQF do not clearly provide guidance and training materials, item J0900D will be provided in the define what constitutes preferences for including a detailed user guide to User Guide. CMS has involved the life-sustaining treatment. As such, we hospices prior to implementation of the measure steward in developing that included data items F2000 (CPR HIS. User Guide. J0900 D is also needed Preference) and F2200 (Hospitalization Comment: We received several because it forms the denominator for Preference) in the HIS to provide comments regarding Section I (Active NQF #1637, pain comprehensive clarification and improve usability. Diagnoses) and item I0010 (Principal assessment. The measure specifications These specifics are important to Diagnosis) that appears in this section. for NQF #1637 indicate that a measure maintenance and development Some commenters felt the item did not comprehensive clinical assessment and does not stray from the measure include enough diagnoses to be useful should include 5 of the following 7 specifications. We will provide and that principal diagnoses was not characteristics of pain: location, guidance and training materials, relevant to the measures. One severity, character, duration, frequency, including a detailed user guide for commenter suggested that we obtain what relieves or worsens the pain, and hospices prior to implementation of the this data from claims or Program for the effect on function or quality of life. HIS. Evaluating Payment Patterns Electronic J0910C provides a checklist of these 7 Comment: For NQF #1647, one Report (PEPPER) reports. items and forms the numerator for NQF commenter questioned which hospice Response: Disease processes and #1637. staff would be eligible to ask the patient conditions impact service delivery. Comment: We received several about concerns related to beliefs and Cancer and dementia/Alzheimer’s comments regarding J0900 (Pain values to satisfy the numerator for the Disease are two of the most common Screening) and J0910 (Pain Assessment). measure. This commenter questions if a principal diagnoses among hospice Some commenters expressed that we

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should provide more clarity on exertion. J2040C helps form the accordance with the hospice’s policies acceptable pain screening tools and numerator for NQF #1639. We believe and procedures related to patient determining patient pain severity. that this item will improve usability by information and clinical records. Regarding J0910C (Comprehensive Pain indicating the treatments/types of Comment: Several commenters Assessment included), one commenter treatment that may be considered inquired about future guidance and indicated that finding the elements of treatment for shortness of breath for training on the HIS. the comprehensive pain assessment in purposes of the measure numerator Response: We will provide guidance the medical record would be tedious. condition. The HIS is not a patient and training materials, including a Response: The measure specifications assessment, and we do not want to be detailed user guide, to hospices prior to for NQF #1634 (Pain Screening) require overly prescriptive in which screening implementation of the HIS. We plan to that patients must be screened for the tools hospices use, particularly for provide Hospices with further presence or absence of pain (and if shortness of breath where there is no information and details about use of the present, a rating of its severity) using a accepted standardized screening or HIS. We will provide this information standardized tool. The HIS is not a assessment tool. We will provide through venues such as postings on the patient assessment, and we do not want guidance and training materials, Hospice Quality Reporting Program Web to be overly prescriptive in which including a detailed user guide to page, Open Door Forums, standardized pain screening tools hospices prior to implementation of the announcements in the CMS E-News, hospices use or how patient pain is HIS. provider training, and National Provider rated. Thus, the items listed in J0900C Comment: One commenter wanted to calls. Electronic data submission will be (Type of standardized pain screening know when N0520 (Bowel Regimen) required for HIS submission in CY 2014 tool used) are not specific screening required a response. and beyond; there will be no other data tools in and of themselves. Instead they Response: As noted on the draft HIS, submission method available. We will are tools that may be utilized for the providers will respond to the bowel make available submission software for assessment of pain severity. Item J0910C items if a scheduled opioid and/or a the HIS to hospices at no cost. We will (Comprehensive pain assessment PRN opioid is initiated or continued. also provide reports to individual included) helps form the numerator for Comment: We received several hospices on their performance on the NQF #1637 (Pain Assessment) and must comments related to Section Z (Record measures calculated from data be retained. We will provide guidance Administration), particularly item submitted via the HIS. The specifics of and training materials, including a Z0400 (Signature(s) of Person(s) the reporting system and precisely when detailed user guide to hospices prior to Completing the Record). Commenters specific measures will be made implementation of the HIS. were unclear on the purpose of this available have not yet been determined. Comment: We received comments on section and how Z0400 should be We will report to providers on the J2030 (Screening for Shortness of completed. following measures on a schedule to be Breath) and J2040 (Treatment for Response: The items in Section Z determined: Shortness of Breath). One commenter appear in and are standardized across • suggested that the respiratory screening data submission vehicles in multiple NQF #1617 Patients Treated with an should require evaluation of shortness CMS quality reporting programs. This Opioid who are Given a Bowel section allows providers to verify, Regimen of breath upon exertion. Another • internally, the individuals responsible NQF #1634 Pain Screening commenter questioned the purpose of • J2040C (Type(s) of treatment for for completing the HIS (that is the NQF #1637 Pain Assessment • shortness of breath initiated). abstracters, not those completing the NQF #1638 Dyspnea Treatment Response: The measure specifications patient assessment). In accordance with • NQF #1639 Dyspnea Screening for NQF #1639 (Dyspnea Screening) do processes used in other care settings, it • NQF #1641 Treatment Preferences not require that the respiratory is suggested that the signature page of • NQF #1647 Beliefs/Values Addressed screening include evaluation upon Section Z be retained by the hospice in (if desired by the patient)

TABLE 6—SUMMARY TABLES

Data submis- Data collection sion APU Impact Measure name

Finalized in the CY 2013 HH PPS Final Rule

1/1/2013–12/31/2013 ...... 4/1/2014 ...... FY 2015 (10/1/2014) ...... Structural/QAPI measure NQF #0209.

Finalized in this Final Rule

7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015) ...... Hospice and Palliative Care—Pain Screening, NQF #1634. 7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015) ...... Hospice and Palliative Care—Pain Assessment, NQF #1637. 7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015)...... Hospice and Palliative Care—Dyspnea Screening, NQF #1639. 7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015)...... Hospice and Palliative Care—Dyspnea Treatment, NQF #1638. 7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015) ...... Patients Treated with an Opioid who are Given a Bowel Regi- men, NQF #1617. 7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015) ...... Hospice and Palliative Care—Treatment Preferences, NQF #1641. 7/1/2014–12/31/2014 ...... Rolling ...... FY 2016 (10/1/2015) ...... Beliefs/Values Addressed (if desired by patient), modified NQF #1647.

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As stated in the August 4, 2011 FY quality measures. Data collected by proposed rule, we will analyze data for 2012 Hospice Wage Index final rule (76 hospices during Q 1, 2 and 3 CY 2015 validity and reliability of quality FR 47302, 47320), we finalized that all will be analyzed starting in CY 2015. measures and review measures’ hospice quality reporting periods Decisions about whether to report some appropriateness for public reporting subsequent to that for Payment Year FY or all of the quality measures publicly prior to determining which measures 2014 will be based on a CY instead of will be based on the findings of analysis will be publicly reported. Moreover, we a calendar quarter and for FY 2015 and of the CY 2015 data. In addition, as appreciate the suggestion to provide a beyond, the data submission deadline noted, the Affordable Care Act requires comprehensive explanation of will be April 1st of each year. The that reporting be made public on a CMS relationships between quality measures implementation of the HIS in July 2014 Web site and that providers have an selected for public reporting and quality will negate the CY data collection opportunity to review their data prior to of care. We will consider this suggestion requirement and the April 1st data public reporting. We will develop the submission deadline. We will provide infrastructure for public reporting, and when developing processes, procedures details on data collection and provide hospices an opportunity to and future proposals for public submission timing prior to review their data. In light of all the steps reporting. We also recognize the implementation of the HIS. required prior to data being publicly importance of outcome data, both for reported, we anticipate that public quality measurement and for public 5. Public Availability of Data Submitted reporting will not be implemented in FY reporting. We also reiterate that we are Under section 1814(i)(5)(E) of the Act, 2016. Public reporting may occur during committed to seeking opportunities to the Secretary is required to establish the FY 2018 APU year, allowing ample use outcome measures—both as part of procedures for making any quality data time for data analysis, review of the quality reporting program and for submitted by hospices available to the measures’ appropriateness for use for public report—as they are developed public. The procedures ensure that a public reporting, and allowing hospices and become endorsed by NQF. hospice will have the opportunity to the required time to review their own review the data regarding the hospice’s data prior to public reporting. We will 6. The CMS Hospice Experience of Care respective program before it is made announce the timeline for public Survey for the FY 2017 Payment public. In addition, under section reporting of data in future rulemaking. Determination and That of Subsequent 1814(i)(5)(E) of the Act, the Secretary is We welcome public comment on what Fiscal Years authorized to report quality measures we should consider when developing Background that relate to services furnished by a future proposals related to public hospice on the CMS Web site. We reporting. In the CY 2013 Home Health recognize that public reporting of Comment: We received a few Prospective Payment System Rate quality data is a vital component of a comments regarding what should be Update final rule (77 FR 67135), we robust quality reporting program and are considered in developing future stated that were considering the use of fully committed to developing the proposals related to public reporting of a patient/family experience of care necessary systems for public reporting hospice quality data. Commenters were survey in addition to other hospice of hospice quality data. We also in favor of public reporting, and quality of care (clinical) measures. We recognize it is essential that the data indicated that they felt it was time to have developed a draft Hospice made available to the public be make this information available to Experience of Care Survey questionnaire meaningful and that comparing consumers. Commenters also indicated performance between hospices requires that they appreciate the opportunity to drawing heavily on questionnaires in that measures be constructed from data review their data prior to the initiation the public domain such as the Family collected in a standardized and uniform of public reporting, and CMS’s efforts to Evaluation of Hospice Care (FEHC). We manner. The development and ensure that public reporting would not are testing the draft survey in a national implementation of a standardized data occur before adequate data analysis had field test in fall 2013. The Hospice set for hospices must precede public taken place to establish the suitability of Experience of Care Survey will treat the reporting of hospice quality measures. the measures for public reporting dying patient and his or her informal Once hospices have implemented the purposes. A few commenters suggested caregivers (family members or friends) standardized data collection approach, that outcome measures and measures as the unit of care. we will have the data needed to from the family experiences of hospice Before the development of this establish the scientific soundness of the care survey would be more meaningful survey, there was no official national quality measures that can be calculated for public reporting than the measures standard experience of care survey that using the standardized data collection. from the HIS. Several commenters had included standard survey It is critical to establish the reliability concerns about which of the NQF administration protocols. The Hospice and validity of the measures prior to measures proposed would be Experience of Care Survey will include public reporting in order to demonstrate appropriate for public reporting. detailed survey administration protocols the ability of the measures to Commenters noted that all of the NQF which will allow for comparisons across distinguish the quality of services measures proposed were process provided. To establish reliability and measures and it may ‘‘take effort’’ for hospices. The survey will focus on validity of the quality measures, at least the public to understand the topics that are important to hospice four quarters of data will need to be relationship of process measures to users and for which informal caregivers analyzed. Typically the first two quality of care. One commenter stated are the best source for gathering this quarters of data reflect the learning that a comprehensive explanation of information. In addition, the ‘‘About curve of the providers as they adopt a this relationship should be provided to You’’ section of the instrument includes standardized data collection; these data the public. demographic characteristics of the are not used to establish reliability and Response: We appreciate and patients and their caregivers which can validity. This means that the data from recognize commenters’ concerns about be used to feed into case mix Q3 and Q4 CY 2014 will not be used for appropriateness of quality measures for adjustments of the publicly reported assessing validity and reliability of the public reporting. As stated in the data.

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Description of the Survey rather than on patient satisfaction. patients in the period from January 1, CAHPS® data complements other data, 2014 through December 31, 2014 will be The Hospice Experience of Care ® Survey will seek information from including clinical measures. CAHPS exempt from the Hospice Experience of informal caregivers of patients who died surveys are specifically intended to Care Survey data collection and while enrolled in hospices. We plan to focus on issues where the patient (or in reporting requirements for the FY 2017 field the questionnaires after the this case the caregiver) is the best source payment determination. The hospices patient’s death. Fielding timelines will of information. We intend the Hospice would be required to submit their be established to give the respondent Experience of Care Survey to have a patient counts for the period of January 1, 2014 through December 31, 2014 to some recovery time (two to three similar focus. Once the survey is final, we will submit it for CAHPS® CMS. The due date for the participation months), while simultaneously not endorsement and National Quality exemption form will be stated in next delaying so long that the respondent is Forum endorsement. year’s rule. To qualify for the small size likely to forget details of the hospice We plan to move forward with a exemption, hospices will need to submit experience. Caregivers will be presented model of survey administration in to CMS their patient counts annually for with a set of standardized questions which we will approve and train survey each future APU period. about their own experiences and the vendors to administer the survey on As part of the national experiences of the patient in hospice behalf of hospices. This will be very implementation, we will develop care. During national implementation of similar to the models that we use for technical specifications for vendors to this survey, hospices will be required to Hospital CAHPS® (HCAHPS) and Home follow and will issue a detailed survey offer the survey, but individual Health CAHPS® (HHCAHPS). Hospices guidelines manual prior to the dry run caregivers will respond only if they will be required to contract with an months. voluntarily chose to do so. approved survey vendor and to provide In addition, there will be a Web site The Hospice Experience of Care the sampling frame to the approved devoted specifically to the Hospice Survey captures such topics as hospice vendor on a monthly basis. Experience of Care Survey. It will provider communications with patients include information and updates and family members, hospice provider Participation Requirements for the regarding survey implementation and care, and patient and family member Survey Begin in CY 2015 for the FY technical assistance. Hospices interested characteristics. The survey will allow 2017 Payment in viewing similar model Web sites are the informal caregiver (family member We proposed that we would begin encouraged to visit the HCAHPS Web or friend) to provide an overall rating of required implementation of the survey site at www.hcahpsonline.org or the the hospice care their patient received, in January 2015 in the FY 2014 Hospice HHCAHPS Web site at https:// and will ask if they will recommend Wage Index and Payment Rate Update; homehealthcahps.org. On these Web ‘‘this hospice’’ to others. Hospice Quality Reporting sites, viewers can see and download the The Hospice Experience of Care Requirements; and Updates on Payment detailed manuals about the surveys (the Survey is following the principles used Reform proposed rule (78 FR 27823, Quality Assurance Guidelines for in the development of the Consumer published May 10, 2013). We are Hospital CAHPS® and the Protocols and Assessment of Healthcare Providers and finalizing the proposed timeline due to Guidelines Manual for Home Health ® Systems (CAHPS ) surveys. Therefore, the importance of the caregiver’s voice. Care CAHPS®), as well as obtain we are— Beginning in first quarter of CY 2015, information about the surveys’ histories, • Obtaining input from consumers hospices will be required to conduct a data submission information, and and stakeholders regarding how hospice dry run of the survey for at least one survey updates. patients perceive hospice care and what month in January 2015, February 2015, Consistent with our other elements in hospice programs are of or March 2015. Beginning in April 2015, implemented surveys, we will provide greatest importance to patients and all hospices will be required to an email address and toll-free telephone informal caregivers. participate in the survey on an ongoing number for technical assistance. • Drafting a version of the hospice basis. The one ‘‘dry run month,’’ plus The Affordable Care Act requires that questionnaire that will be cognitively the nine months of April 2015 to beginning with FY 2014 and each tested with a small number of December 2015 participation, will be subsequent FY, the Secretary shall respondents in both English and required to meet the pay for reporting reduce the market basket update by 2 Spanish. This type of testing will allow requirement of the Hospice Quality percentage points for any hospice that us to assess how respondents interpret Reporting Program for the FY 2017 does not comply with the quality data and respond to individual questionnaire annual payment update. submission requirements with respect to items. Approved Hospice Experience of Care the FY. Any such reduction would not • Providing a field test of the Hospice Survey vendors will submit data on the be cumulative and would not be taken Experience of Care Survey instrument hospice’s behalf to the CMS hospice into account in computing the payment after the development of an initial patient experience of care survey data amount for subsequent FYs. In the questionnaire is completed. This field center. The deadlines for data November 8, 2012 CY 2013 Home test will allow us to review survey submission have not yet been finalized. Health Prospective Payment System implementation procedures and use For the ‘‘dry run’’ the survey vendor final rule (77 FR 67068), it was stated statistical analysis of the survey results would follow all the national that all hospice quality reporting to select the final set of questions. In implementation procedures, but the periods subsequent to that for Payment addition, it will allow us to select data would not be publicly reported. Year 2014 would be based on a CY variables which may be used in the case The dry run would provide hospices rather than on a FY. We are finalizing mix adjustment of survey results for and their vendors with the opportunity adding the Hospice Experience of Care public reporting. to work together under ‘‘test’’ Survey to the Hospice Quality Reporting The Hospice Experience of Care circumstances. We will allow Program requirements for the FY 2017 Survey, as well as the CAHPS® family exemptions for very small hospices. payment determination. To meet the FY of surveys, focuses on patient Hospices that have fewer than 50 2017 requirements, hospices would perspectives on the experience of care, unduplicated or unique deceased participate in a dry run for at least 1

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month of the first quarter of CY 2015 approved survey vendors, oversight of than the FEHC, which has 54 items, and (January 2015, February 2015, March the approved survey vendors, the public a shorter instrument will translate into 2015) and hospices must collect the reporting of the data, and the data lower vendor costs for the participating survey data on a monthly basis for the analysis of the hospice survey data. hospices. To give an example of this, the months of April 1, 2015 through Before national implementation begins field test version of the HHCAHPS December 31, 2015 in order to qualify in 2015, hospices are strongly survey had 54 items and the final for the full APU. encouraged to shop around for the best approved version of the survey that we The following is a summary of the cost value for them before contracting use today, has 34 items. comments we received regarding the with an approved survey vendor to Comment: We received a comment Hospice Experience of Care Survey conduct the Hospice Experience of Care expressing the preference that NHPCO proposal. Survey on their behalf. Hospices cannot be allowed to be a survey vendor for the Comment: We received a number of self-administer the survey because we Hospice Experience of Care Survey. comments that the timeline for need to eliminate any potential bias in Response: We will be using survey implementation of the Hospice the administration of the survey. We do vendor eligibility criteria that are very Experience of Care Survey placed it too not believe that the annual burden to similar or identical to our other close in proximity to the hospices will exceed the annual burden CAHPS® surveys, and if NHPCO meets implementation of the HIS items and and costs that we see in the the stated survey vendor eligibility that there should be a gap of at least 12 implementation of HHCAHPS. criteria then we welcome NHPCO to months between the HIS Basically, once national implementation complete the survey vendor application implementation and the survey starts, hospices will need to choose a for the hospice experience of care implementation dates. vendor and contract with them, and survey. Response: We carefully reviewed the then they will be responsible on a Comment: We received comments comments asking for a delay in the monthly basis to produce a file of all the that we are administering the survey too timing of the national implementation caregivers (the persons on the records close to the death of the patient. of the Hospice Experience of Care for the hospice patients) for hospice Response: We thank you for this Survey. However, we concluded that patients who died in the past month. comment. We are sensitive that a survey obtaining data from caregivers is so We are not surveying people who have about this issue will be difficult for the important that we cannot delay. As living hospice patients. We cannot fully families and friends of their loved ones proposed we will begin with a dry run comment on whether the survey costs to who have passed, especially in the first in the first quarter of 2015. Continuous the individual hospice providers will year following the deaths. We anticipate data collection will begin April, 1, 2015 outweigh the costs of the loss of 2 administering the survey about two or for the 2017 APU. percent of the APU. However, most three months following the deaths of the Comment: We received comments survey costs will be much less than the hospice patients. We are hesitant about that there are financial and loss of the 2 percent reduction in the waiting too long following the deaths administrative burdens on hospices APU. Small hospices serving 50 or because the survey respondents may participation in the Hospice Experience fewer patients in an annual period will forget the details of the hospice of Care Survey. Commenters also stated complete (annually) a Participation experiences if the survey is that the financial burden of Exemption Request Form so that they administered too long following the participation would outweigh the 2 will not incur survey costs. The CMS deaths. percent reduction in the annual hospice survey will require the Comment: We received several payment update that would be given to approved survey vendors to implement comments supporting CMS for non-participating hospices. We also the survey in accordance to a uniform developing a new survey instrument received comments stating that this set of protocols and guidelines to assure that is independent of existing hospice would require more staffing and the consistency in the survey survey instruments, and that has the development of a process to handle the administration, in the implementation uniform survey implementation ® implementation of the survey and of other CMS CAHPS® surveys, such as guidelines of the CAHPS surveys. comments that this is a burden to small HCAHPS, and HHCAHPS. Response: We appreciate this support hospices. We received a comment Comment: We received comments of the CMS survey instrument. We are ® asking if hospices can self-administer that the draft hospice experience of care following the CAHPS guidelines and ® the survey to save costs in survey instrument is too long and we will apply for CAHPS endorsement implementing the hospice survey. In ‘‘daunting’’ to read and respond to. as well as the endorsement of the addition, we received a comment that Response: This is a survey that is National Quality Forum. Commenters the Family Evaluation of Hospice Care going to be used in a national field test supporting us noted that the final (FEHC) survey does not pose a financial in fall 2013. There are more questions survey instrument will be shorter and burden to hospices because the FEHC in this test survey than we intend to that we will allow flexibilities in the survey is a benefit of National Hospice keep in the final survey. We anticipate implementation of the survey that will and Palliative Care Organization that we will eliminate questions that do allow hospices to add their own (NHPCO) membership. not contribute to the composites questions, but that the core questions Response: We appreciate the measuring key areas of the hospice care will be used for valid comparisons comments concerning that the proposed experience. We do anticipate keeping all across hospices because we will define survey is a financial burden to of the demographic questions, because the protocols and guidelines for the participating hospices. We are using the they will be used to adjust the results implementation of the survey to create same survey implementation model that for differences in the mix of patients an equal implementation process for the we use for other CAHPS® surveys where across hospices and for analysis of survey. providers pay approved survey vendors disparities of care. It is important that Comment: We received a comment to conduct the data collection on their the data are adjusted to ensure accurate that we cannot regulate payment based behalf and CMS pays for the survey comparisons across hospices. We on what the living family members vendor training, technical support and actually anticipate that the final survey think of hospice care because it is not assistance for hospices and their instrument will be significantly shorter possible to make everyone happy and

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asking about this experience post death Experience of Care Survey, and that questions about why CMS is mandating seems odd and could result in a larger there should not be a 2 percent the new survey in place of the FEHC. percentage of negative responses. reduction since hospices save money for We also received a comment that CMS Response: We appreciate this Medicare. should allow the FEHC to be substituted viewpoint. However, the survey itself Response: We are requiring the survey for the CMS Hospice Survey. does not focus on the death. It focuses for all hospices, to meet the goals of Response: We respect the work that on the hospice care and the details transparency for hospices regardless of went into the FEHC; however, we about the experience of care with the their location. We believe that the cannot allow the FEHC to substitute for hospice. The survey’s purpose is to burden to rural and urban hospices is the CMS survey. To be useful to the provide useful information to other equal, and we reiterate that small public, Hospice Survey data must be caregivers and families who are in the hospices serving 50 or fewer in a given comparable across hospices. Two position of comparing hospices for the year will be exempt from survey different surveys would create care of their loved ones. participation if they complete the inconsistencies among hospices that Comment: We received a comment survey’s Participation Exemption would not allow for direct comparisons. that there are many family and friends Request form for each APU. In addition, the FEHC was designed by at the time of the death but that they Comment: We received a comment and for a private entity. CMS must may not be present after the death when asking if CMS would require the survey ensure that no private entity has a the survey goes out. We also received a to be available in other languages, such preferred relationship with the agency. comment that some hospices will send as Spanish. The CMS survey was developed under out multiple surveys to family members Response: Vendors will be required to the standards of the CAHPS® surveys who had perceived good experiences, offer the survey in English and Spanish. and will be implemented with the and conversely, will not send out Hospices will be able to administer the rigorous guidelines of the CAHPS® surveys to family members who are survey in additional languages if needed surveys. mentally ill, or were not involved in the for their patient populations; however, Comment: A commenter stated that hospice patient’s care, even if they were they must use the CMS official the dry run should be 3 months, instead listed as the closest relative. We translations. We plan to make additional of 1 month. received a comment that the results may translations of the survey available as Response: The requirement for the dry be skewed by the family member’s needed. If you would like to request a run is 1 month, but hospices are degree of contact with the patient and specific translation, please email CMS at allowed to do 2 or 3 months, in the hospice team. [email protected]. Response: We appreciate these period of January through March 2015. Comment: We received a comment Comment: We received a comment sensitive comments concerning who stating that it is not clear whether will be the survey respondent. We that consideration needs to be given to hospices are given the full credit for the diverse audiences responding to the propose to have a uniform standard for survey participation regardless of the the designation of the survey survey. Issues related to primary survey results. language, socioeconomic status, culture, respondent. We propose that the survey Response: We stated in the proposed and health literacy, may impact the respondent will be the person who is rule that survey participation is required completion of the survey and the listed in the hospice record as the for the full APU; the data results are not responses to the survey questions. primary caregiver or primary contact part of the requirements for the APU. person for the hospice patient. The survey requirement is part of the Response: We agree with this Comment: We received a comment Hospice Quality Reporting Program; this commenter and will adjust the survey that surveys should not be sent more is not a pay for performance program. results for respondent mix. We will also than two times to families as there is a Comment: We received a comment be offering multiple translations and need not to be too intrusive. stating that their vendor for the FEHC different modes of survey Response: For the field test, we will notifies them immediately about administration so hospices can choose have one survey mode, called the mixed negative comments that are received what meets their needs the best. mode that includes both a mail survey about their hospice. This commenter Comment: We received a comment and telephone follow-up for non- noted that there is no information in the that consideration needs to be given to respondents. If the survey respondent proposed rule that describes how the the smaller agency where one negative does not return the mailed comment section of the proposed survey survey can skew the data results for that questionnaire, then the survey agency. will be used, or available to the hospice ® respondent is called and asked to paying for survey service. Response: For other CAHPS surveys, complete the telephone survey Response: Hospices will still be able we have received comments about the instrument. For national to have this arrangement with their comparability of the data for small implementation of the survey, we will respective vendors in the CMS Hospice providers with large providers. In the have three modes: Mail only, telephone Experience of Care Survey. practice of statistics, it is established only, and mixed. For the mail only Comment: We received a comment that the sample size in absolute mode, only two surveys are mailed to asking if hospices will be responsible numbers is more important than the the sampled person. For the telephone for a certain response rate for the proportion of the population surveyed. only mode, there will be up to five call Hospice Experience of Care Survey. Surveying a sample of 300 will produce attempts to reach the sampled Response: No, hospices will not be the same level of precision whether the respondent, but once the sampled responsible for a certain response rate sample large or small. The larger the respondent answers the telephone and for the Hospice Experience of Care sample, the less the variability is a speaks with the telephone surveyor, the Survey. However, all approved survey provider’s ratings over time. We will be respondent will only be asked to vendors must follow the survey proposing the required sample sizes for complete the survey once. administration protocols to implement all hospices in next year’s proposed Comment: We received comments the survey. rule. Small agencies will need to that rural hospices will be at a Comment: We received a comment of conduct census sampling if they do not disadvantage paying for the Hospice support for the FEHC survey and qualify for the size exemption.

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Comment: We received a comment Guidelines Manual, which has not been for length of hospice stay and for the that CMS needs to know what its written. care setting. ultimate goal is of the surveys without Comment: We received a comment Response: We will use the data from losing sight of the goal itself. that the survey should meet the quality the field test to determine if the Response: The goals of the Hospice needs of individual hospices. administrative data (such as length of Experience of Care Survey are the same Response: We hope that the survey stay and hospice setting) has an impact ® as the goals of our other CAHPS will serve the quality needs of all on the survey data results. surveys: (1) To produce comparable data hospices. However, hospices may have Comment: We received comments on the caregiver’s or loved one’s’ unique quality needs and hospices will that CMS should not exempt very small perspectives on care that allow objective be permitted to add their own rural hospices from the requirements. and meaningful comparisons between additional questions to the standardized Response: Besides the burden to these hospices on domains that are important survey. hospices, there is the issue of privacy to to consumers; (2) to create incentives for Comment: We received comments the respondents. In very small settings, hospices to improve their quality of care that the caregiver of record is not always it could be apparent who the survey through public reporting of survey the best person to receive the survey. respondents are. Also, there are results; and (3) to enhance public Response: We are aware the caregiver sampling and reliability issues because accountability in health care by of record may not be the best person to the sample and the data could be very increasing the transparency of the receive the survey. However, because small. quality of the care provided in return for the hospice is likely to have contact Comment: We received comments the public investments. CMS is serious information for this person, they are the stating that it is going to be very difficult about these three goals for all of our ® best person for us to contact. for survey respondents to complete the perspectives of care/CAHPS surveys, Comment: We received comments survey if their loved ones changed and we intend to never lose sight of expressing the concern that collecting hospice settings. their importance. demographic information from Response: At the beginning of the Comment: We received a comment respondents could reduce response, survey, respondents are instructed to that the first portion of the survey is especially from minority populations. In reply to the questionnaire as pertaining nearly identical to HHCAHPS, while the to the last setting of hospice care. latter portion seems more representative addition, commenters said that asking Comment: We received comments of hospices. This commenter stated that for this information could raise privacy questions regarding goals of care or the and confidentiality concerns. We suggesting that CMS add questions to patient’s plan of care were absent, two received a comment suggesting CMS the survey. The suggested topics for areas of particular importance for redesign the Hospice Experience of Care added items include questions hospices. This commenter also noted Survey so that there were no survey specifically relevant to veterans as well that questions regarding after-hour questions about demographic as questions about care planning, care response to needs were absent, an area characteristics. The commenter has goals, and volunteers. known to create much anxiety for received feedback that no one likes to Response: One of the concerns often patients and families. answer those kinds of questions. expressed to us is that the CMS Hospice Response: We reviewed both surveys Response: We ask for demographic Experience of Care Survey is too long. side-by-side and disagree with this information on surveys for two We intend to shorten the survey after commenter about the similarity to purposes: First, to allow us to make case the field test. In this context, we are HHCAHPS. We have some similar mix adjustments so that hospices’ reluctant to add still more questions to questions, but this is because in focus survey responses can be compared the core survey instrument. However, groups and later testing these issues fairly. We have not determined how we know that it can be important for were all raised by our testing case mix adjustments will be calculated providers to ask questions that are not participants. Also, we have many for this survey, and therefore, need on the approved core survey instrument. questions about care. We also have demographic variable to test different Hospices will be permitted to add their questions about after-hour response to case mix adjustment variables. Second, own questions to the survey, following needs. They are: ‘‘While your family we also need demographic information the required core set of questions. member was in hospice care, did you to allow for research on health care Comment: We had one comment that need to contact the hospice team during disparities between groups of people, suggested the follow-up schedule for the evenings weekends or holidays for including minorities. All sampling data, field test of the Hospice Experience of questions or help with your family which will include these items, will be Care Survey was too aggressive and member’s care?, and ‘‘How often did treated as private and confidential. The would make family members or friends you get the help you needed from the approved survey vendors who conduct of the deceased feel harassed. hospice team during evenings, these surveys will be responsible for Response: Our follow-up plan for the weekends, or holidays? maintaining the security, privacy and field test is very typical for professional Comment: We received a comment confidentiality of sampling information mixed-mode surveys. We plan to mail a about transitioning from the current and survey results in accordance with survey to the sample members. Sample FEHC program to the CMS Hospice HIPAA requirements. Above all, the members who have not responded Survey. completion of the survey is voluntary within three weeks will receive follow- Response: We do not have any for all persons who receive the survey up telephone calls. We will make up to relationship to the FEHC program. in the mail, or who are telephoned and a maximum of five telephone calls, at Hospices can continue to continue to are asked to complete the survey on the different days and times, in an effort to use the FEHC. However, the FEHC telephone. Any person who receives the reach the sample member. If we have cannot be substituted for the CMS survey, or who is telephoned and is not reached the sample member after Hospice Experience of Care Survey. asked to complete the survey, is free not five attempts, calls will be curtailed. If Hospices can conduct both surveys to complete the survey. the sample member is reached but under specific conditions that will be Comment: We received a comment refuses to complete the survey, no more detailed in the CMS Hospice Survey that the survey data should be adjusted calls will be made. We will not

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repeatedly call the sample member and The purpose of this notification is to put www.whitehouse.gov/omb/bulletins/ ask for a response. hospices on notice of the following: (1) b03-04.html. In the FY 2006 Hospice That they have been identified as being Wage Index final rule (70 FR 45139), we Summary of Final Rule Changes for the non-compliant with section 3004 of the implemented a 1-year transition policy Hospice Experience of Care Survey Affordable Care Act for the reporting using a 50/50 blend of the CBSA-based As a result of these comments, we are cycle in question; (2) that they would be wage index values and the MSA-based finalizing the requirements as proposed. scheduled to receive a reduction in the wage index values for FY 2006. The Hospices must participate in and report amount of 2 percentage points to the one-year transition policy ended on data from a dry run for at least 1 month annual payment update to the September 30, 2006. For the FY 2007 in the first quarter of CY 2015 (January applicable fiscal year; (3) that they may hospice wage index and beyond, we 2015, February 2015, or March 2015) file a request for reconsideration if they have used CBSAs exclusively to with continuous monthly data believe that the finding of non- calculate wage index values. OMB has collection beginning in April 1, 2015 compliance is erroneous, or that if they published subsequent bulletins and continuing through December 31, were non-compliant, they have a valid regarding CBSA changes. The OMB 2015. and justifiable excuse for this non- bulletins are available at http:// 7. Notice Pertaining to Reconsiderations compliance; and, (4) that they must www.whitehouse.gov/omb/bulletins/ Following APU Determinations follow a defined process on how to file index.html. a request for reconsideration, which When adopting OMB’s new labor At the conclusion of any given quality would be described in the notification. market designations in FY 2006, we data reporting period, we will review Upon the conclusion of our review of identified some geographic areas where the data received from each hospice each request for reconsideration, we there were no hospitals, and thus, no during that reporting period to would render a decision. We could hospital wage index data, which to base determine if the hospice has met the reverse our initial finding of non- the calculation of the hospice wage reporting requirements. Hospices that compliance if: (1) The hospice provides index. We also adopted the policy that, are found to be non-compliant with the proof of full compliance with the all for urban labor markets without a reporting requirements set forth for that requirements during the reporting hospital from which hospital wage reporting cycle could receive a period; or (2) the hospice was not able index data could be derived, all of the reduction in the amount of 2 percentage to comply with requirements during the CBSAs within the state would be used points to their annual payment update reporting period, and it provides to calculate a statewide urban average for the upcoming payment year. pre-floor, pre-reclassified hospital wage We are aware that there may be adequate proof of a valid or justifiable excuse for this non-compliance. We index value to use as a reasonable proxy situations when a hospice has evidence for these areas in our August 6, 2009 FY to dispute a finding of non-compliance. would uphold our initial finding of non- compliance if the hospice could not 2010 Hospice Wage Index final rule (74 We further understand that there may be FR 39386). In FY 2014, the only CBSA times when a provider may be show any justification for non- compliance. without a hospital from which hospital prevented from submitting quality data wage data could be derived is 25980, due to the occurrence of extraordinary C. FY 2014 Hospice Wage Index and Hinesville-Fort Stewart, Georgia. circumstances beyond their control (for Rates Update In our August 31, 2007 FY 2008 example, natural disasters). It is our goal 1. Hospice Wage Index Hospice Wage Index final rule (72 FR not to penalize hospice providers in 50214), we implemented a new these circumstances or to unduly The hospice wage index is used to methodology to update the hospice increase their burden during these adjust payment rates for hospice wage index for rural areas without a times. agencies under the Medicare program to hospital, and thus no hospital wage Other CMS Quality Reporting reflect local differences in area wage data. In cases where there was a rural Programs, such as Home Health Quality levels based on the location where area without rural hospital wage data, Reporting and Inpatient Quality services are furnished. The hospice we used the average pre-floor, pre- Reporting, include an opportunity for wage index utilizes the wage adjustment reclassified hospital wage index data providers to request a reconsideration factors used by the Secretary for from all contiguous CBSAs to represent pertaining to their APU determinations. purposes of section 1886(d)(3)(E) of the a reasonable proxy for the rural area. In We are aware of the potential need for Act for hospital wage adjustments and our August 31, 2007 FY 2008 Hospice providers to request reconsideration and our regulations at § 418.306(c) require Wage Index final rule, we noted that we that we will be making APU each labor market to be established interpret the term ‘‘contiguous’’ to mean determinations for FY 2014 in the using the most current hospital wage sharing a border (72 FR 50217). coming months. Therefore, to be data available, including any changes by Currently, the only rural area without a consistent with other established quality the Office of Management and Budget hospital from which hospital wage data reporting programs, we used the (OMB) to the Metropolitan Statistical could be derived is Puerto Rico. proposed rule to notify providers of our Areas (MSAs) definitions. We have However, our policy of imputing a rural intent to provide a process that would consistently used the pre-floor, pre- pre-floor, pre-reclassified hospital wage allow hospices to request reclassified hospital wage index when index based on the pre-floor, pre- reconsiderations pertaining to their FY deriving the hospice wage index. In our reclassified hospital wage index (or 2014 and subsequent years’ payment August 4, 2005 FY 2006 Hospice Wage indices) of CBSAs contiguous to a rural determinations. Index final rule (70 FR 45130), we began area without a hospital from which Specifically, as part of the adopting the revised labor market area hospital wage data could be derived reconsideration process for hospices definitions as discussed in the OMB does not recognize the unique beginning with the FY 2014 payment Bulletin No. 03–04 (June 6, 2003). That circumstances of Puerto Rico. While we determinations, hospices found to be bulletin announced revised definitions have not identified an alternative non-compliant with the reporting for MSAs and the creation of Core-Based methodology for imputing a pre-floor, requirements during a given reporting Statistical Areas (CBSAs). The bulletin pre-reclassified hospital wage index for cycle would be notified of that finding. is available online at http:// rural Puerto Rico, we will continue to

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evaluate the feasibility of using existing data sometimes submitted by the index, which is updated yearly and is hospital wage data and, possibly, wage hospital on their cost report data and used by many other CMS payment data from other sources. For FY 2008 the added responsibility for the hospice systems, is the most appropriate method through FY 2013, we have used the to monitor the hospital wage index. available to account for geographic most recent pre-floor, pre-reclassified Some commented that the phase out of variances in labor costs for hospices. hospital wage index available for Puerto the BNAF will leave the hospice Regarding about the commenters Rico, which is 0.4047. In this final rule, industry with an exceptionally concerns regarding the CBSA for FY 2014, we will continue to use the imprecise and un-validated wage index classification of Montgomery County, most recent pre-floor, pre-reclassified with large geographic variations that Maryland, it is important to note that hospital wage index value available for cannot be defended by local wage the cities and counties which make up Puerto Rico, which is 0.4047. pressures. Some commenters stated that CBSAs are not determined by CMS, but For the FY 2014 Hospice Wage Index CMS should actively seek the instead are established by the Office of and Payment Rate Update proposed rule Congressional authority for granting Management and Budget (OMB) and (78 FR 27840), we proposed to use the hospices wage index parity with have been adopted by Medicare through 2013 pre-floor, pre-reclassified hospital hospitals until an appropriate notice and comment rule making. In our wage index to derive the applicable alternative wage index approach for August 4, 2005 FY 2006 Hospice Wage wage index values for the FY 2014 hospices and other post-acute providers Index final rule (70 FR 45130), we began hospice wage index. We proposed to can be developed. One commenter adopting the revised labor market area continue to use the pre-floor, pre- asked CMS to re-evaluate the CBSA for definitions as discussed in the OMB reclassified hospital wage data as a basis Montgomery County, Maryland as it is Bulletin No. 03–04 (June 6, 2003). In to determine the hospice wage index considered a rural area at paid at a addition, in the FY 2006 Hospice Wage values because hospitals and hospices lower rate than all the surrounding Index final rule (70 FR 45130), we both compete in the same labor markets, counties. implemented a 1-year transition policy and therefore, experience similar wage- Response: The pre-floor, pre- using a 50/50 blend of the CBSA-based related costs. We believe the use of the reclassified hospital wage index was wage index values and the MSA-based pre-floor, pre-reclassified hospital wage wage index values for FY 2006. The adopted in 1998 as the wage index from index data as a basis for the hospice one-year transition policy ended on which the hospice wage index is wage index results in the appropriate September 30, 2006. For FY 2007 and derived by a committee of CMS (then adjustment to the labor portion of the beyond, we have used CBSAs Health Care Financing Administration) costs. The FY 2014 hospice wage index exclusively to calculate wage index and industry representatives as part of values presented in this final rule were values. Moreover, we also note that a negotiated rulemaking effort. The computed consistent with our pre-floor, under the hospice payment system, Negotiated Rulemaking Committee pre-reclassified hospital wage index payments are wage-adjusted based on considered several wage index options: policy (that is, our historical policy of the location of the beneficiary. not taking into account Inpatient (1) Continuing with Bureau of Labor Final Decision: After carefully Prospective Payment System (IPPS) Statistics data; (2) using updated considering all of the comments that we geographic reclassifications in hospital wage data; (3) using hospice received on our proposal to use the 2013 determining payments for hospice). The specific data; and (4) using data from pre-floor, pre-reclassified hospital wage 2013 pre-floor, pre-reclassified hospital the physician payment system. The index to derive the applicable wage wage index does not reflect OMB’s new Committee determined that the pre- index values for the FY 2014 hospice area delineations, based on the 2010 floor, pre-reclassified hospital wage wage index, we are finalizing the Census, as outlined in OMB Bulletin index was the best option for hospice. proposal as discussed in the FY 2014 13–01, released on February 28, 2013. Each hospice’s labor market area is Hospice Wage Index and Payment Rate Moreover, the final FY 2014 pre-floor, based on definitions of CBSAs issued by Update proposed rule. pre-reclassified hospital wage index the Office of Management and Budget 2. FY 2014 Hospice Wage Index With an does not contain OMB’s new area (OMB), not CMS. We note that section Additional 15 Percent Reduced Budget delineations because those changes 3137(b) of the Affordable Care Act Neutrality Adjustment Factor (BNAF) were not published until the IPPS requires CMS to submit to Congress a proposed rule was in advanced stages of report that includes a plan to reform the This final rule will update the hospice development (78 FR 27552). CMS hospital wage index system. The report wage index values for FY 2014 using intends to propose changes to the FY to Congress outlines the recent history 2013 pre-floor, pre-reclassified hospital 2015 hospital wage index based on the of analysis and proposed reform to the wage index. As described in the August newest CBSA changes in the FY 2015 Medicare wage index system. This 8, 1997 Hospice Wage Index final rule IPPS proposed rule. Therefore, if CMS report was submitted by the Secretary (62 FR 42860), the pre-floor and pre- incorporates OMB’s new area on April 11, 2012. The report can be reclassified hospital wage index is used delineations, based on the 2010 Census, found at: http://www.cms.gov/Medicare/ as the raw wage index for the hospice in the FY 2015 hospital wage index, Medicare-Fee-for-Service-Payment/ benefit. These raw wage index values those changes would also be reflected in AcuteInpatientPPS/Wage-Index- are then subject to either a budget the FY 2016 hospice wage index. Reform.html. The latest information on neutrality adjustment or application of We received nine comments on our hospital wage index reform is discussed the hospice floor to compute the proposal to use the 2013 pre-floor, pre- in the ‘‘Hospital Inpatient Prospective hospice wage index used to determine reclassified hospital wage index to Payment Systems for Acute Care payments to hospices. Pre-floor, pre- derive the applicable wage index values Hospitals and the Long-Term Care reclassified hospital wage index values for the FY 2014 hospice wage index, Hospital Prospective Payment System below 0.8 are adjusted by either: (1) The which are summarized below. and Fiscal Year 2013 Rates;’’ final rule, hospice budget neutrality adjustment Comment: Some commenters published August 31, 2012 in the factor (BNAF); or (2) the hospice floor commented that is difficult to have the Federal Register (77 FR 53660–53664). subject to a maximum wage index value hospice wage index dependent on the We continue to believe that the pre- of 0.8; whichever results in the greater hospital wage index due to the lack of floor, pre-reclassified hospital wage value.

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The BNAF is calculated by computing percent) was 0.045422, based on a full many rural providers. However, we will estimated payments using the most BNAF of 0.060562; the additional 15 continue to monitor for unintended recent, completed year of hospice percent reduced BNAF for FY 2012 (for consequences associated with the BNAF claims data. The units (days or hours) a cumulative reduction of 40 percent) phase-out. from those claims are multiplied by the was 0.035156, based on a full BNAF of 3. Hospice Payment Update Percentage updated hospice payment rates to 0.058593; the additional 15 percent calculate estimated payments. For the reduced BNAF for FY 2013 (for a Section 4441(a) of the Balanced FY 2014 Hospice Wage Index final rule, cumulative reduction of 55 percent) was Budget Act of 1997 (BBA) amended that means estimating payments for FY 0.027197, based on a full BNAF of section 1814(i)(1)(C)(ii)(VI) of the Act to 2014 using units (days or hours) from 0.060438; and the additional 15 percent establish updates to hospice rates for FY 2012 hospice claims data, and reduced BNAF for FY 2014 (for a FYs 1998 through 2002. Hospice rates applying the FY 2014 hospice payment cumulative reduction of 70 percent) is were to be updated by a factor equal to rates. The FY 2014 hospice wage index 0.018461, based on a full BNAF of the market basket index, minus 1 values are then applied to the labor 0.061538. percentage point. Payment rates for FYs portion of the payments. The procedure Hospital wage index values which are since 2002 have been updated according is repeated using the same units from less than 0.8 are subject to the hospice to section 1814(i)(1)(C)(ii)(VII) of the the claims data and the same payment floor calculation. For example, if in FY Act, which states that the update to the rates, but using the 1983 Bureau of 2013, County A had a pre-floor, pre- payment rates for subsequent FYs must Labor Statistics (BLS)-based wage index reclassified hospital wage index (raw be the market basket percentage for that instead of the updated raw pre-floor, wage index) value of 0.3994, we would FY. The Act requires us to use the pre-reclassified hospital wage index perform the following calculations using inpatient hospital market basket to (note that both wage indices include the budget-neutrality factor (which for determine the hospice payment rate their respective floor adjustments). The this example is an unreduced BNAF of update. In addition, section 3401(g) of total payments are then compared, and 0.061538, less 70 percent, or 0.018461) the Affordable Care Act mandates that, the adjustment required to make total and the hospice floor to determine starting with FY 2013 (and in payments equal is computed; that County A’s hospice wage index: Pre- subsequent FYs), the hospice payment adjustment factor is the BNAF. floor, pre-reclassified hospital wage update percentage will be annually The August 6, 2009 FY 2010 Hospice index value below 0.8 multiplied by 1+ reduced by changes in economy-wide Wage Index final rule (74 FR 39384) 70 percent reduced BNAF: (0.3994 × productivity as specified in section finalized a provision to phase out the 1.018461 = 0.4068); Pre-floor, pre- 1886(b)(3)(B)(xi)(II) of the Act which is BNAF over 7 years, with a 10 percent reclassified hospital wage index value 0.5 percentage point for FY 2014. In reduction in the BNAF in FY 2010, and below 0.8 multiplied by 1 + hospice addition, section 3401(g) of the an additional 15 percent reduction in floor: (0.3994 × 1.15 = 0.4593). Based on Affordable Care Act also mandates that each of the next 6 years, with complete these calculations, County A’s hospice in FY 2013 through FY 2019, the phase out in FY 2016. Once the BNAF wage index would be 0.4593. hospice payment update percentage will is completely phased out, the hospice An Addendum A and Addendum B, be reduced by an additional 0.3 floor adjustment would simply consist with the FY 2014 wage index values for percentage point (although for FY 2014 of increasing any wage index value less rural and urban areas, will not be to FY 2019, the potential 0.3 percentage than 0.8 by 15 percent, subject to a published in the Federal Register. The point reduction is subject to suspension maximum wage index value of 0.8. FY 2014 wage index values for rural under conditions specified in section Therefore, in accordance with the FY areas and urban areas are available via 1814(i)(1)(C)(v) of the Act). In FY 2014 2010 Hospice Wage final rule (74 FR the internet at: http://www.cms.gov/ Hospice Wage Index and Payment Rate 39384), the BNAF for FY 2014 will be Medicare/Medicare-Fee-for-Service- Update proposed rule (78 FR 27841), we reduced by an additional 15 percent for Payment/Hospice/index.html. The FY proposed 1.8 percent hospice payment a total BNAF reduction of 70 percent (10 2014 hospice wage index set forth in update percentage which was based on percent from FY 2010, an additional 15 this final rule includes the BNAF a 2.5 percent estimated inpatient percent from FY 2011, an additional 15 reduction and will be effective October hospital market basket update for FY percent for FY 2012, an additional 15 1, 2013 through September 30, 2014. 2014 reduced by a 0.4 percentage point percent for FY 2013 and an additional We received nine comments which productivity adjustment and by 0.3 15 percent in FY 2014). referenced the BNAF reduction, and are percentage point as mandated by the The unreduced BNAF for FY 2014 is summarized below. Affordable Care Act. The final hospice 0.061538 (or 6.1538 percent). A 70 Comment: Several commenters payment update percentage for FY 2014 percent reduction to the BNAF is continued to voice opposition to the is 1.7 percent and is based on the final computed to be 0.018461 (or 1.8461 BNAF reduction and were concerned inpatient hospital market basket update percent). For FY 2014, this is about the impact of the elimination of for FY 2014 of 2.5 percent reduced by mathematically equivalent to taking 30 BNAF phase-out. a 0.5 percentage point productivity percent of the unreduced BNAF value, Response: The BNAF phase-out has adjustment and by 0.3 percentage point or multiplying 0.061538 by 0.30, which already been finalized for the remaining as mandated by the Affordable Care Act. equals 0.018461 (1.8461 percent). The years of the phase-out, as described in A detailed description of how the BNAF of 1.8461 percent reflects a 70 the FY 2010 Hospice Wage Index final inpatient hospital market basket is percent reduction in the BNAF. The 70 rule (74 FR 39384). However, we are derived is described in the FY 2014 percent reduced BNAF (1.8461 percent) sensitive to the issues raised by IPPS Final Rule. Due to the was applied to the pre-floor, pre- commenters, especially the possible requirements at 1886(b)(3)(B)(xi)(II) and reclassified hospital wage index values effects of the BNAF reduction. Our 1814(i)(1)(C)(v) of the Act, the inpatient of 0.8 or greater. The 10 percent reduced analysis reveals an overall growth in hospital market basket update for FY BNAF for FY 2010 was 0.055598, based number of hospices since the start of the 2014 of 2.5 percent must be reduced by on a full BNAF of 0.061775; the phase-out. We also note that the FY a productivity adjustment as mandated additional 15 percent reduced BNAF FY 2014 hospice wage index includes a by Affordable Care Act (0.5 percentage 2011 (for a cumulative reduction of 25 hospice floor calculation which benefits point for FY 2014). The inpatient

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hospital market basket for FY 2014 is annually in the summer to provide hospice is paid the routine home care reduced further by a 0.3 percentage adequate time to implement system rate for each day the beneficiary is point, as mandated by the Affordable change requirements; however, starting enrolled in hospice, unless the hospice Care Act. In effect, the final hospice in this FY 2014 rule and for subsequent provides continuous home care, payment update percentage for FY 2014 FYs, we proposed in the FY 2014 inpatient respite care, or general is 1.7 percent. Hospice Wage Index and Payment Rate inpatient care. Continuous home care is The labor portion of the hospice Update proposed rule to use rulemaking provided during a period of patient payment rates are as follows: for as the means to finalize hospice crisis to maintain the patient at home, Routine Home Care, 68.71 percent; for payment rates. This change was inpatient respite care is short-term care Continuous Home Care, 68.71 percent; proposed to be consistent with the rate to allow the usual caregiver to rest, and for General Inpatient Care, 64.01 update process in other Medicare general inpatient care is to treat percent; and for Respite Care, 54.13 benefits, and would provide rate symptoms that cannot be managed in percent. The non-labor portion of the information to hospices as quickly as, or another setting. payment rates is as follows: for Routine earlier than, when rates are published in The final FY 2014 payment rates will Home Care, 31.29 percent; for an administrative instruction. Continuous Home Care, 31.29 percent; be the FY 2013 payment rates, increased for General Inpatient Care, 35.99 There are four payment categories that by 1.7 percent, which is the final percent; and for Respite Care, 45.87 are distinguished by the location and hospice payment update percentage for percent. intensity of the services provided. The FY 2014 as discussed in section IV.C.3 base payments are adjusted for above. The final FY 2014 hospice 4. Final FY 2014 Hospice Payment Rates geographic differences in wages by payment rates will be effective for care Historically, the hospice rate update multiplying the labor share, which and services furnished on or after has been published through a separate varies by category, of each base rate by October 1, 2013, through September 30, administrative instruction issued the applicable hospice wage index. A 2014.

TABLE 7—FINAL FY 2014 HOSPICE PAYMENT RATES UPDATED BY THE FINAL HOSPICE PAYMENT UPDATE PERCENTAGE

Multiply by the FY 2014 final Code Description FY 2013 hospice pay- FY 2014 final Payment rates ment update payment rate of 1.7 percent

651 .... Routine Home Care ...... $153.45 × 1.017 $156.06 652 .... Continuous Home Care Full Rate = 24 hours of care = 37.95 hourly rate ...... 895.56 × 1.017 910.78 655 .... Inpatient Respite Care ...... 158.72 × 1.017 161.42 656 .... General Inpatient Care ...... 682.59 × 1.017 694.19

The Congress required in sections update reduced by 2 percentage points. required to begin collecting quality data 1814(i)(5)(A) through (C) of the Act that In the August 4, 2011 FY 2012 Hospice in October 2012, and submit that quality hospices begin submitting quality data, Wage Index final rule (76 FR 47320 data in 2013. Hospices failing to report based on measures to be specified by the through 47324), we implemented a quality data in 2013 will have their Secretary. Beginning in FY 2014, Hospice Quality Reporting Program market basket update reduced by 2 hospices which fail to report quality (HQRP) as required by section 3004 of percentage points in FY 2014. data will have their market basket the Affordable Care Act. Hospices were

TABLE 8—FINAL FY 2014 HOSPICE PAYMENT RATES UPDATED BY THE FINAL HOSPICE PAYMENT UPDATE PERCENTAGE FOR HOSPICES THAT DO NOT SUBMIT THE REQUIRED QUALITY DATA

Multiply by the FY 2014 hospice payment FY 2013 update per- FY 2014 Code Description Payment rates centage of 1.7 Payment rate percent minus 2 percentage points (¥0.2)

651 ...... Routine Home care ...... $153.45 × 0.997 $152.99 652 ...... Continuous Home Care Full Rate = 24 hours of care = 37.20 hourly rate 895.56 × 0.997 892.87 655 ...... Inpatient Respite Care ...... 158.72 × 0.997 158.24 656 ...... General Inpatient Care ...... 682.59 × 0.997 680.54

A Change Request with the finalized October 31, 2013 will continue to be Comment: Commenters were FY 2014 hospice payment rates, a issued in the summer. supportive of CMS’ proposal to use finalized FY 2014 hospice wage index, We received two comments on our rulemaking as the means to finalize the FY 2014 PRICER, and the hospice proposal to use rulemaking as the means hospice payment rates followed by a cap amount for the cap year ending to finalize hospice payment rates, which change request with the finalized are summarized below. hospice payment rates, a finalized

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hospice wage index, the PRICER for FY monitor the impact of our regulations meetings where research findings were 2014. for any unintended consequences. As presented on potential payment system Response: We thank you for your described in the Regulatory Impact vulnerabilities; utilization of the support. We will finalize hospice Analysis (Section, VI), we note that the Medicare Hospice Benefit, including payment rates as stated in the FY 2014 overall impact of this final rule is an general inpatient care use during the Hospice Wage Index and Payment Rate estimated net increase in Federal period the beneficiary is enrolled in Update proposed rule (78 FR 27841). payments to hospices of $160 million, hospice care; analysis of hospice cost Comment: We also received several or 1.0 percent, for FY 2014. reports; and the effects of the face-to- additional comments that expressed Final Decision: As stated in the FY face encounter requirement. These and concern that hospice industry is being 2014 Hospice Wage Index and Payment other findings are described in the Abt over regulated, while reimbursement is Rate Update proposed rule, we Hospice Study Technical Report, which decreasing and examples given include proposed to finalize hospice payment is available on the CMS Hospice Center the face-to-face regulation, data rates through rulemaking and we are Web page, at http://www.cms.gov/ collection efforts, and quality initiatives. finalizing this policy as proposed. A Center/Provider-Type/Hospice- Several commenters are concerned that change request with the finalized FY Center.html. these regulations not only increase 2014 hospice payment rates, a finalized Additionally, we continue to conduct financial burden for hospice industry FY 2014 hospice wage index, the FY analyses of various payment reform but also pull hospices away from patient 2014 PRICER, and the hospice cap year model options under consideration. care and keep hospice providers in the ending October 31, 2013 will continue These models include a U-shaped office to perform administrative duty to to be issued in the summer. model of resource use, which MedPAC comply with regulations. Some D. Update on Hospice Payment Reform recommended that we adopt, as commenters described a shortage of staff originally described in Chapter 6 of its in some areas of the country, especially and Data Collection March, 2009 report entitled ‘‘Report to small hospices and in rural areas, and In 2010, the Congress amended the Congress: Medicare Payment Policy’’ stated that the staff travel hours in rural section 1814(i)(6) of the Act with (available online at: http:// areas to examine the patient, which is section 3132(a) of the Affordable Care www.medpac.gov/chapters/ a burden itself because of travel Act. The amendment authorized the Mar09_Ch06.pdf). The report noted that distance. Several commenters stated Secretary to collect additional data and the constancy of the per diem payment that reimbursement is decreasing information determined appropriate to over the course of a hospice stay is because of the continuing rate cuts revise payments for hospice care and for misaligned with a hospice’s costs during resulting from the elimination of the other purposes. The types of data and the stay. A hospice’s costs typically budget neutrality adjustment factor, the information described in the Act would cuts resulting from the productivity capture resource utilization and other follow a U-shaped curve, with higher adjustment factor, and further rate measures of cost, which can be collected costs at the beginning and end of a stay, reduction resulting from sequestration. on claims, cost reports, and possibly and lower costs in the middle of the A commenter stated that the proposed other mechanisms determined to be stay. This cost curve reflects hospices’ hospice payment update of 1.8 percent appropriate. The data collected may be higher service intensity at the time of for 2014, coupled with other cuts is used to revise the methodology for the patient’s admission and the time devastating. determining the payment rates for surrounding the patient’s death Response: We appreciate comments routine home care, and other services (MedPAC, page 358). Payment under a regarding sequestration cut, but it is included in hospice care, no earlier than U-shaped model would be higher at the outside the scope of this rule. As stated October 1, 2013 as described in section beginning and end of a hospice stay and in FY 2013 Hospice Wage Index notice 1814(i)(6)(D) of the Act. In addition, we lower in the middle portion of the stay. (77 FR 44245), section 3401(g) of the are required to consult with hospice Analysis conducted by Abt Associates Affordable Care Act mandates that programs and the Medicare Payment found that very short hospice stays have starting with FY 2013 (and in Advisory Commission (MedPAC) a flatter curve than the U-shaped curve subsequent FYs), the market basket regarding additional data collection and seen for longer stays and that average percentage update under the hospice payment revision options. hospice costs are much higher. These payment system as described in section The proposed rule contained three short stays are less U-shaped because 1814(i)(1)(C)(ii)(VII) or section subsections which updated the public there is not a lower-cost middle period 1814(i)(1)(C)(iii) of the Act will be or discussed different aspects of hospice between the time of admission and the annually reduced by changes in payment reform; there were no time of death. As such, we are also economy-wide productivity as set out at proposals in any of these three considering a tiered approach, with section 1886(b)(3)(B)(xi)(II) of the Act. subsections. payment tiers based on the length of We do not have authority to change the stay. For example, payment for stays of application of economy-wide 1. Update on Reform Options 5 days or less, which occurred for about productivity adjustment as it is required Our hospice contractor, Abt 25 percent of hospice beneficiaries in by the statute. We are sensitive to Associates, continues to conduct 2011, could be made under a per diem concerns about hospices being research and analyses, to identify system that accounts for the higher overregulated and concerns expressed potential data collection needs, and to hospice costs, with no variation in the from rural hospices that the additional research and develop hospice payment rate based on length of stay as would time and distance required to visit a model options. To date, we completed occur under a U-shaped model. rural patient adds significantly to their an environmental scan; a draft analytic Payment for longer stays, where costs costs. We do not have the authority to plan; and convened technical advisory follow more of a U-shape, could be change the hospice rates beyond the panel meetings under the initial made under a tier based on the U- limits set out in the statute, but will contract with Abt in 2010. We are shaped payment model, where the per consider the costs of rural providers in continuing with these efforts under a diem amount fluctuates depending the context of broader hospice payment contract awarded in September 2011. In upon whether the days billed are at the system reform. We will continue to June 2012, we convened stakeholder beginning, middle, or end of the stay.

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Another option is to analyze whether beneficiary requires several visits from management of terminally ill patients. a short-stay add-on payment, similar to the hospice provider. However, we are still evaluating data the home health Low Utilization When the hospice benefit was created and did not propose any changes to Payment Amount (LUPA) add-on, in 1983, the RHC base payment rate was address the misalignment. would improve payment accuracy if we set using nine different components of At this time, we do not have the data retain the current per diem system. The cost from a relatively small set of to support rebasing six of the nine cost LUPA add-on is made for home health hospices (n = 26) that were participating components described in the 1983 final patients who require four or fewer visits in a CMS hospice demonstration, as rule. Information on the utilization of during the 60-day episode. These home described in the December 16, 1983 drugs, supplies, and equipment is not health episodes are paid based on the Hospice final rule (48 FR 56008). The available from hospice claims data, and visits actually furnished during the nine cost components were: nursing the corresponding information that is episode. For LUPA episodes that occur care ($16.25); home health aide ($12.74); available from cost reports, such as as the only episode or the first episode social services/therapy ($3.23); home outpatient hospital therapies, is not in a sequence of adjacent home health respite ($1.46); interdisciplinary group sufficiently detailed to allow for episodes for a given beneficiary, an ($2.78); drugs ($1.18); supplies ($4.49); rebasing. One approach to consider in increased payment is made to account equipment ($1.13); and outpatient more closely aligning RHC payments for the front-loading of costs (see hospital therapies ($2.99). The sum of with costs is to rebase the three clinical http://www.cms.gov/Outreach-and- all the components’ costs equaled the service components (nursing, home Education/Medicare-Learning-Network- base payment rate for RHC as stated in health aide, social services/therapy) that MLN/MLNProducts/downloads/ that 1983 hospice final rule. The currently comprise 69.7 percent of the HomeHlthProspaymt.pdf for more original RHC rate was set at $46.25. In RHC rate by calculating the average cost information). addition to RHC, we also established per day, weighted by the number of Finally, as we collect more accurate three other levels of care for hospice RHC days, for each of the three diagnosis data, including data on related care from data obtained from the components using FY 2011 cost report conditions, we will also evaluate Medicare hospice demonstration data matched to FY 2011 claims data. whether case-mix should play a role in project: Continuous Home Care (CHC), As part of rebasing the RHC rate we determining payments. Inpatient Respite Care (IRC) and General would then inflate the 1983 cost per day a. Rebasing the Routine Home Care Inpatient Care (GIP). for each of the six remaining (RHC) Rate It is CMS’ intent to ensure that components by a factor of 3.1704, which In the proposed rule, we updated our reimbursement rates under the Hospice corresponds to the market basket 8 review of the hospice RHC rate, but did benefit align as closely as possible with increases between 1983 and 2011. We not include any proposals to rebase the the average costs hospices incur when note that our cost report analysis thus rate. Rebasing the RHC rate involves efficiently providing covered services to far found that drug costs over the years using the existing components that beneficiaries. As we continue to gather have declined, and the other non-labor make up the rate, and recalculating and analyze more data for payment components are plateauing. A detailed based on more current data. RHC is the reform, we have found evidence of a methodology for rebasing the clinical basic level of care under the Hospice potential misalignment between the service components of the RHC rate can benefit, where a beneficiary receives current RHC payment rate and the cost be found in the Abt Hospice Study hospice care, but remains at home. With of providing RHC. One potential option Technical Report which was published this level of care, hospice providers are to address this misalignment could be to shortly after displaying the proposed reimbursed per day regardless of the rebase the hospice RHC rate, though we rule, at http://www.cms.gov/Center/ volume or intensity of services provided did not propose to do so in the proposed Provider-Type/Hospice-Center.html. to a beneficiary on any given day. It is rule, so that the cost categories Using the methodology described anticipated that there would be days established in the rate reflect the above, the rebased amount for FY 2011 when a beneficiary does not require any changes in the utilization of hospice would be $130.54 as described in Table services, as well as days when a services provided for palliation and 9 below.

TABLE 9—COMPARISON OF RHC RATE COST COMPONENTS FROM 1983 TO FY 2011

1983 Final FY 2011 RHC components rule cost per Inflation Cost per day factor day

Nursing Care ...... $16.25 N/A $56.54 Home Health Aide ...... 12.74 N/A 19.24 Social Services/Therapy ...... 3.23 N/A 10.29 Home respite ...... 1.46 × 3.1704 4.63 Interdisciplinary group ...... 2.78 × 3.1704 8.81 Drugs ...... 1.18 × 3.1704 3.74 Supplies ...... 4.49 × 3.1704 14.23 Equipment ...... 1.13 × 3.1704 3.58 Outpatient Hospital Therapies ...... 2.99 × 3.1704 9.48 Total ...... 46.25 ...... 130.54 Source: 1983 Final Rule and FY 2011 hospice cost report and claims data.

8 The original RHC rate in 1983 was $46.25. The FY 2011 rate for RHC was $146.63. $146.63/46.25 = 3.1704.

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Note(s): The costs per day for the clinical services components (nursing care, home health aide and social services/therapy) were calculated based on the cost per minute for each discipline using cost report data multiplied by the RHC minutes for each discipline per RHC day from claims data to compute the cost of a discipline per RHC day. The average cost per day across all hospices in our sample was weighted by the number of RHC days. Of the 2,717 FY 2011 hospice cost reports for freestanding and facility-based hospices that were matched to FY 2011 claims data, we excluded: (1) Cost reports with period less than 10 months or greater than 14 months; (2) cost reports with missing information or negative reported values for total costs or payments; (3) providers in the highest and lowest percentile (1% and 99%) in costs per days across all levels of care; (4) the top and bottom 5% of provider margin; and (5) providers were excluded if the log payment to cost ratio was greater than the 90th or less than the 10th percentile of this value across all providers plus or minus 1.5 times the range between the 10th and 90th percent- iles of this log ratio. The number of hospices remaining in our sample was 2,140 representing 73.1 percent of RHC days in 2011.

For example, if we were to apply the through the reduction of the RHC rate are paid for under the hospice benefit. rebased amounts for the clinical services would need to be redistributed in a To lessen this incentive, the OIG components of RHC to FY 2014, we budget neutral manner. recommended that we reduce Medicare would inflate the FY 2011 rebased payments for hospice care provided in b. Site of Service Adjustment for amount to FY 2013 levels. We first nursing facilities. Hospice Patients in Nursing Facilities. inflated the FY 2011 rebased rate by full In addition, the March 2012 Medicare hospital market basket of 3.0 percent for As part of future hospice payment Payment Advisory Commission FY 2012. The FY 2012 rebased rate reform, we are considering an OIG (MedPAC) report entitled ‘‘Report to would be $134.46 ($130.54 × 1.03 = recommendation to reduce payments to Congress: Medicare Payment Policy’’ $134.46). We then inflated the FY 2012 Medicare hospices for beneficiaries in noted that hospices with a higher share rebased rate by full hospital market nursing facilities who are receiving of their patients in nursing facilities basket of 2.6 percent for FY 2013. The hospice care. The OIG’s July 2011 report have margins as high as 13.8 percent FY 2013 rebased rate would be $137.96 entitled ‘‘Medicare Hospices that Focus (pages 302 and 303). MedPAC attributed ($134.46 × 1.026 = $137.96). Finally, we on Nursing Facility Residents,’’ these higher margins to possible inflated the rebased FY 2013 rate (available at https://oig.hhs.gov/oei/ efficiencies in the nursing home setting ($137.96) by applying the proposed reports/oei-02-10-00070.pdf) studied (multiple patients in a single setting, hospice payment update percentage of hospice patients in nursing facilities. reduced driving time and mileage), and 1.8 percent to calculate a FY 2014 This report noted the growth of hospice to reduced workload due to an overlap rebased RHC rate. Therefore, the FY services provided to beneficiaries in in aide services and supplies provided 2014 rebased rate would be $140.44, a nursing facilities, and discussed by the nursing facility. 10.1 percent reduction in the FY 2014 hospices that have a high percentage of In response to both MedPAC’s and proposed RHC payment rate of $156.21, their beneficiaries in nursing facilities. OIG’s concerns about possible or an estimated reduction in payments The OIG’s report noted that the current duplication of aide services provided to hospices of $1.6 billion in FY 2014. payment structure provides incentives both by the hospice and the nursing Rebasing the clinical service for hospices to seek out beneficiaries in facility, in the proposed rule we components of the RHC payment is one nursing facilities, as these beneficiaries discussed an analysis of the number and of several approaches to hospice often receive longer but less complex length of aide visits per day using 2011 payment reform that CMS could care. The OIG noted that unlike private hospice claims data. Table 10 below consider for revising the RHC payment homes, nursing facilities are staffed with describes the number and length of aide rate. As outlined in the Affordable Care professional caregivers and are often visits for RHC beneficiaries at home Act, hospice payment reform must be paid by third-party payers, such as (including patients in an assisted living done in a budget neutral manner. As Medicaid. These facilities are required facility) compared to RHC beneficiaries rebasing is considered part of hospice to provide personal care services, which in a long term care nursing facility (NF) payment reform, any savings achieved are similar to hospice aide services that or skilled nursing facility (SNF).

TABLE 10—HOSPICE ROUTINE HOME CARE AIDE SERVICES, CY 2011

Sites of service Difference Home Q5001/2 NF/SNF Q5003/4 NF/SNR–Home %

Number of beneficiaries ...... 769,640 302,004 (467,636) ...... Total days ...... 58,637,171 22,946,972 (35,690,199) ...... Total visits ...... 16,625,635 8,501,366 (8,124,269) ...... Total minutes ...... 1,223,254,095 584,825,520 (638,428,575) ...... Visits per beneficiary ...... 21.6 28 .1 6 .5 30.3 Minutes per visit ...... 73 .6 68.8 (4 .8) 6.5 Total visits/day ...... 0.28 0 .37 0.09 30.7 Total minutes/day ...... 20 .86 25 .49 4.62 22.2 Source: Abt Associates Hospice Claims Data File, CY 2011.

Table 10 demonstrates that hospice (20.86 minutes). The Medicare beneficiaries’ needs. It seems reasonable patients in a NF/SNF receive more visits Conditions of Participation (CoPs) to expect that a beneficiary who has a than patients at home, though the length require that hospices provide services at paid caregiver (that is, a NF/SNF aide) of those visits is shorter. Average the same level and to the same extent as does not need as many services from the minutes per day shows that RHC those services would be provided if the hospice aide, because those services are patients in a NF/SNF had hospice aide NF/SNF resident were in his or her being provided by the paid caregiver. As services of longer duration (25.49 home. Hospices provide aide services to described in the June 5, 2008 Hospice minutes) than RHC patients at home beneficiaries at home depending on the Conditions of Participation final rule (73

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FR 32095), ‘‘[h]ospice care is meant to or services which are not reasonable and Other hospice service costs include supplement the care provided by the necessary for the palliation and non-labor costs such as drugs, durable patient’s caregiver.’’ Given the presence management of the terminal illness. medical equipment (DME), supplies, of the paid caregiver in the NF/SNF, we Services which are not needed, or imaging, patient transportation, and would expect that on average, there which are duplicative of those to be outpatient services. These types of would be fewer hospice aide services provided by the facility aide, would not services represent about 20 to 25 provided to hospice patients in a NF/ be reasonable and necessary. percent of total hospice costs. Drugs, SNF than to hospice patients at home. In the proposed rule, we did not DME, and supplies account for 90 It is not clear why hospice patients in propose to make a site of service percent of these other hospice services nursing facilities are receiving more adjustment to reduce payments for RHC costs. Drug costs have trended minutes per day of aide services than patients in a nursing facility. Any downward over time, while medical hospice patients at home. We used reform option considering reduced supply costs have remained steady. regression analysis to control for age, payments for RHC care provided to Finally, in examining non-reimbursable gender, diagnosis, length of stay, and hospice patients in a NF or SNF should costs, we found that 26 percent of provider characteristics (ownership not result in a reduction in the services providers in 2010 showed no status, base, size, age of hospice, that hospice patients in NFs or SNFs bereavement costs on their cost report, geographic location) when analyzing the receive, but would instead be a shifting even though bereavement services are visit data. However, we still found that of who provides those aide services; required by statute; it is unclear if significantly more aide services were some of the services currently provided bereavement services were not provided provided to NF/SNF patients than to by the hospice aide would be provided or if bereavement costs were not patients at home, even after controlling by the facility aide as expected. As such, correctly reported. for patient and provider characteristics. we do not expect that the quality of care The report also describes an analysis The June 5, 2008 Hospice Conditions to hospice patients in a NF/SNF would of GIP utilization. In 2010 through 2011, of Participation final rule (73 FR 32088) be diminished. If such a policy were to a quarter of all hospice beneficiaries had preamble details the requirements be finalized and implemented, it would at least one GIP stay, with a quarter of related to aide services provided to be made in a budget neutral manner as those stays associated with cancer hospice patients residing in a nursing required by the Affordable Care Act. In diagnoses. While most GIP stays were 2 facility. These requirements can also be addition, we would monitor for any days long, the average GIP length of stay found at § 418.112(c)(4) through (5). The unintended consequences. was 5.66 days, reflecting a small number CoPs require a written agreement of extremely long GIP stays. Sixty-five 2. Reform Research Findings between the hospice and NF/SNF, percent of GIP stays were provided in a which specifies that the NF/SNF should The proposed rule also included a hospice inpatient unit. Almost 80 continue to provide the aide services discussion of a number of analyses we percent of hospices provided at least that are provided prior to the hospice conducted to better understand hospice one GIP day in 2010 through 2011. election, to meet the patient’s needs at utilization and trends, to identify Hospices that provided GIP tended to be that same level of care as if the patient vulnerabilities in the payment system, older and larger. were at home. These services include and to develop and test models that The Abt Hospice Study Technical providing 24 hour room and board care, would more accurately match hospice Report also provides descriptive meeting the patient’s personal care resource use with Medicare payments. statistics for all beneficiaries and for 3 needs, and to the degree permitted by We posted the Abt Hospice Study major sites of routine home care State law, administering medications or Technical Report on hospice payment services. It includes visit data findings, therapies. There should be no reduction reform on our hospice center Web page, including visits per day, visits per of NF/SNF aide services to a patient in located at: http://www.cms.gov/Center/ beneficiary, minutes per day, and anticipation of a future hospice election, Provider-Type/Hospice-Center.html. minutes per beneficiary for key or once the patient (or his/her The report summarizes research disciplines reported on hospice claims. representative) elects the hospice findings related to resource use and Additionally, there are several figures benefit. As such, hospice patients in payment system vulnerabilities. which depict the U-shaped curve for nursing facilities should have much, if The report also includes a discussion key personnel by length of stay. The not most, of their need for aide services of hospice cost report analyses. Overall, curves show that resource use tends to provided by the facility’s aide. As stated the total cost per election period has not follow a U-shaped curve, but one which previously, we would expect that, on significantly increased from 2007 to is higher at the beginning rather than at average, the hospice aide would be 2010, in real dollars. Inpatient costs the end of the hospice stay. There was providing fewer services to nursing constitute about 14 percent of hospice little evidence that strong differences in facility patients than to patients at costs across freestanding hospice the U-shape exist across most subgroups home. providers that reported inpatient costs. (for example, freestanding vs. provider- Table 10 suggests that the hospice About one-third of providers reported based, ownership status, patient aide may be replacing the facility aide, no inpatient costs. It appeared that some diagnosis). rather than supplementing or providers with no inpatient costs were For more detailed information on augmenting the care of the facility aide. substituting continuous home care these findings, and a description of the Or, as the OIG and MedPAC identified, (CHC) for GIP, based on analysis of the methods used, see the Abt Hospice there could be an overlap in aide proportion of CHC days. Visiting Study Technical Report, which is services when a hospice beneficiary is services (for example, direct labor costs posted on the hospice center Web page in a NF/SNF. It would not be for nurses, aides, social workers, (http://www.cms.gov/Center/Provider- appropriate for the Medicare Hospice counselors, and therapists) account for Type/Hospice-Center.html). We have Benefit to subsidize the nursing home about two-thirds of hospice costs, and also posted a review of pertinent benefit by providing aide services that have trended upward from 2004 to hospice literature as of December 2012 the facility aide should provide. Section 2010. Nursing care, hospice aides, and on the hospice center Web page. This 1862(a)(1)(C) of the Social Security Act medical social services comprise 90 should be considered an evolving (the Act) forbids payment for any items percent of visiting service costs. document, as Abt Associates updates

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the review periodically. We encourage noted that it would not be difficult to instead. Some noted that they purchase interested stakeholders to review this get this information and enter it into some drugs in larger quantities, making update on our progress. We will their systems. A few commenters noted reporting at the patient level more continue to collaborate with other that sometimes patients are in more complicated. A few noted that this federal experts regarding hospice than one facility type during a claim could be done, but said that hospices payment reform research efforts and to period, but that there is only space for would need lead time to prepare update stakeholders on our progress on one NPI on the claim. systems to track and report at the hospice payment reform. • Post-mortem visits on the calendar patient level. One suggested that we day of death. Commenters suggested we specify what cost structure drug charges 3. Additional Data Collection collect visit data for various timeframes should be based upon, such as average Over the past several years, MedPAC, after the time of death, rather than the wholesale price plus a percentage. the Government Accountability Office calendar day of death, since many In summary, commenters were largely (GAO), and the HHS Office of Inspector deaths occur late at night. They supportive of our suggestions to collect General (OIG) have also recommended suggested we clarify what we mean by additional visit and NPI data on claims. that we collect more comprehensive time of death (time death actually Many suggested collecting data on DME, data in order to better understand the occurs, or time the death is supplies, and drugs from the cost utilization of the Medicare Hospice pronounced). Several commenters reports, rather than at the patient level. Benefit. In the proposed rule, we noted suggested we gather post-mortem visit Several commenters reminded us that that in December 2012 we posted a data regardless of level of care or site of their primary focus is patient care, and document to our Hospice Center Web service. were concerned about the cost of such page (http://www.cms.gov/Center/ • Any durable medical equipment data collection. We appreciate the Provider-Type/Hospice-Center.html) (DME) provided by the hospice. Some comments submitted, and will consider describing additional data collection commenters indicated that this would this input as we move forward towards which we are considering, and noting be difficult to collect and record on implementing any new data collection that cost report revisions are claims. Many indicated that DME for hospices. We issued Change Request forthcoming. We received 65 comments suppliers bill them monthly, and 8358 on Friday, July 26, 2013 detailing about the claims data collection items waiting for the DME invoice would the new data collection requirements. under consideration, which are briefly cause a delay in submission of their Section 3132(a)(1)(C) of the summarized below. claims. They also noted that it would Affordable Care Act also authorizes us • Line item visit data, including take a great deal of lead time to set this to collect more data on hospice cost length of visit in 15-minute increments, up with suppliers and software vendors reports. The revisions to the hospice for hospice chaplains and counselors to track DME at the patient level. A few cost report and its associated providing care to hospice beneficiaries. suggested that we use aggregate data on instructions are described in detail in a Commenters were supportive, but DME costs from the cost reports instead. revision to the information collection • suggested we include phone calls by Non-routine supplies provided by request currently approved under OMB chaplains and counselors, and allow the hospice. Most commenters indicated control number 0938–0758. As required reporting of chaplain time spent that this would be difficult to collect by the Paperwork Reduction Act, we officiating or attending beneficiary and record on claims. A number of published the both 60-day and 30-day funerals, as this is part of their service commenters wrote that their software notices with comment periods in the to families. A few suggested that we does not accommodate such reporting, Federal Register on April 29, 2013 (78 have a separate category for and that it would create an additional FR 25089). Bereavement Counseling to burden on clinical staff to track these The proposed rule did not solicit acknowledge this requirement even if it items. Several mentioned that it would comments on our hospice payment is not subject to reimbursement. Several take some lead time to modify existing reform updates and discussions, but we suggested we define ‘‘other counselors.’’ systems to enable hospices to track and received 54 comments on this section. • Line item visit data, including report this information accurately. A We thank the commenters for their length of visits in 15-minute increments, few suggested we use aggregate data on input and we will consider the for hospice staff providing care to non-routine supplies from the cost comments received as we move forward hospice patients receiving GIP in a reports instead. with hospice payment reform. hospital or nursing facility, but not for • Drugs (injectable, non-injectable, hospice patients receiving GIP in a and over-the-counter) provided by the E. Technical and Clarifying Regulations hospice facility. Our suggestion to hospice. Most commenters indicated Text Change collect GIP visit data did not include that this would be difficult to collect We proposed to incorporate the visits by non-hospice staff, and was and record on claims. Several asked if following technical change to correct an focused on patients in a hospital or injectable drugs include infusion erroneous cross reference in our nursing facility only. Therefore, GIP pumps, which is considered DME. regulations text. visits to hospice patients in hospice Several commenters noted that the inpatient facilities continue to be hospice staff person is not always the Administrative Appeals (§ 418.311) reported as weekly totals, without person administering drugs, making A hospice that does not believe its including the length of visits. tracking more complicated; they payments have been properly Commenters were generally supportive, suggested focusing on the fills, rather determined may request a review from provided the visits were for hospice than drugs administered. Some wrote the intermediary or from the Provider staff only. Several comments noted that that hospices get their drugs from Reimbursement Review Board (PRRB), this would be no more difficult than multiple pharmacies, making reporting depending on the amount in what already occurs when recording more difficult due to inconsistencies in controversy. Section 418.311 details the visits to patients’ homes. pharmacy billing. Others wrote that procedures for appealing a payment • The National Provider Identifier their data systems are not able to track decision and also refers to 42 CFR part (NPI) of facilities where hospice patients drugs by patient, and suggested that we 405, subpart R. The rationale for this are receiving care. Most commenters use aggregate data from the cost reports appeals process was explained in the

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August 22, 1983 Hospice proposed rule Hospice quality reporting program, we submissions by each hospice annually (48 FR 38146) and finalized in the seek to collect measure information or 49 submissions monthly. December 16, 1983 Hospice final rule with as little burden to the providers as For the Admission Hospice Item Set, (48 FR 56008). Hospices are permitted possible and which reflects the full we estimate that it will take 14 minutes to appeal computation of the payment spectrum of quality performance. of time by a clinician such as a limit or the amount due to the hospice We proposed and will implement a Registered Nurse at an hourly wage of to the PRRB if the amount in Hospice Experience of Care Survey to $33.23 to abstract data for Admission controversy is $10,000 or more. reflect the patients’ families’ and Hospice Item Set. This will cost the We made a technical correction in friends’ perspectives of care in hospices. hospice approximately $7.75 for each § 418.311 to correct an erroneous The 60-day notice for the field test of admission assessment.9 We further reference to § 405.1874. The published the survey was published on April 4, estimate that it will take 5 minutes of reference to § 405.1874 does not exist 2013 (78 FR 20323) under CMS–10475 time by clerical or administrative staff and was a typographic error. We are (OCN 0938-New). While we set out the person such as a medical data entry correcting this error by changing the requirements and burden estimates for clerk or medical secretary at an hourly referenced § 405.1874 to § 405.1875— the field study, it is too early to set out wage of $15.59 to upload the Hospice Administrator review. Section 405.1875 the requirements and burden estimates Item Set data into the CMS system. This allows for the Administrator, at his or for the national implementation of the will cost the hospice approximately her discretion, to immediately review survey. We anticipate having the final $1.30 per assessment.10 For the any decision of the Board as described survey instrument in 2014 and setting Discharge Hospice Item Set, we estimate in the August 22, 1983 proposed and out the collection of information that it will take 5 minutes of time by a December 16, 1983 final rules (48 FR requirements and burden estimates in clinician such as a nurse at an hourly 38159, and 48 FR 56019, respectively). the proposed rule for CY 2015. We will wage of $33.23 to abstract data for We received no comments on this implement the survey in 2015. Discharge Hospice Item Set. This will proposed technical correction, and are In this final rule we are requiring cost the hospice approximately $2.77. implementing the correction as implementation of a hospice patient- We further estimate that it will take 5 proposed. level item set to be used by all hospices minutes of time by clerical or V. Collection of Information to collect and submit standardized data administrative staff such as a medical Requirements on each patient admitted to hospice. data entry clerk or medical secretary at This Hospice Item Set will be used to an hourly wage of $15.59 to upload data Under the Paperwork Reduction Act support the standardized collection of into the CMS system. This will cost the of 1995, we are required to provide 60- the requisite data elements to calculate hospice approximately $1.30. day notice in the Federal Register and quality measures. Hospices will be We estimate that the total nursing solicit public comment before a required to complete and submit an time required for completion of both the collection of information requirement is admission HIS and a discharge HIS on admission and discharge assessments is submitted to the Office of Management all patients admitted to hospice starting 19 minutes at a rate of $33.23 per hour. and Budget (OMB) for review and July 1, 2014 for FY 2016 APU The annualized cost across all Hospices approval. In order to fairly evaluate determination. The admission and for the nursing/clinical time required to whether an information collection discharge HIS will collect the complete both the admission and should be approved by OMB, section standardized data elements needed to discharge Hospice Item sets is estimated 3506(c)(2)(A) of the Paperwork calculate 7 NQF endorsed measures for to be $11,458,528 and the cost to each Reduction Act of 1995 requires that we hospice. individual Hospice is estimated to be solicit comment on the following issues: • Using 2011 Medicare claims data we $3,062.14. The estimated time burden to The need for the information hospices for a medical data entry clerk collection and its usefulness in carrying have estimated that there will be approximately 1,089,719 admissions to complete the admission and out the proper functions of our agency. discharge Hospice Item Set assessments • The accuracy of our estimate of the across all hospices per year and is 10 minutes at a rate of $15.59 per information collection burden. therefore, we expect that there should • The quality, utility, and clarity of be 1,089,719 Hospice Item Sets hour. The cost for completion of the the information to be collected. (consisting of one admission and one both the admission and discharge • Recommendations to minimize the discharge item set per patient), Hospice Item sets by a medical data information collection burden on the submitted across all hospices yearly. entry clerk is estimated to be $2,829,401 affected public, including automated There were 3,742 certified hospices in across all Hospices and $756.12 to each collection techniques. the U.S. as of October 1, 2012; we Hospice. We solicited public comment on each estimate that each individual hospice The total combined time burden for of these issues for this section of this will submit on average 291 Hospice completion of the Admission and document that contains information Item Sets annually or 24 Hospice Items Discharge Hospice Data Item Sets is collection requirements (ICRs). Sets per month. estimated to be 29 minutes. The total Section 1814(i)(5)(C) of the Act The Hospice Item Set consists of both annualized cost across all hospices is requires that each hospice submit data an admission and a discharge data estimated to be $14,287,929. For each to the Secretary on quality measures collection. As noted above, we estimate individual hospice, this annualized cost specified by the Secretary. Such data that there will be 1,089,719 hospice is estimated to be $3,818.26. The must be submitted in a form and admissions across all hospices per year. estimated cost for each individual manner, and at a time specified by the Therefore, we expect there to be Hospice Item Set submission is $13.11. Secretary. Under section 2,179,438 Hospice Item Set 1814(i)(5)(D)(iii) of the Act, the submissions, (both admission and 9 14 minutes of time by a Registered Nurse at $33.23/60 minutes per hour = $0.56; $0.56 per one Secretary must publish selected discharge data) submitted across all × hospices annually or 181,620 across all minute 5 minutes = $7.75. measures that will be applicable with 10 5 minutes of time by a Medical Data Entry respect to FY 2014 not later than hospices monthly. We further estimate Clerk at $15.59/60 minutes per hour = $0.265; October 1, 2012. In implementing the that there will be 582 Hospice Item Set $0.265 per one minute × 5 minutes = $1.30.

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Comment: We received several varying patient assessment forms during approaches that maximize net benefits comments indicating concern about the initial patient assessment; all (including potential economic, general burden that would be associated hospices were able to crosswalk items environmental, public health and safety with implementing and using the HIS. from their hospice’s patient assessment effects, distributive impacts, and Commenters stated hospices will have forms to the HIS data elements, and equity). Executive Order 13563 to conduct training among staff to complete the HIS items. Therefore, the emphasizes the importance of implement and use the HIS, in addition HIS did not add new data collection quantifying both costs and benefits, of to staff time that will be required to efforts to the hospice’s customary reducing costs, of harmonizing rules, complete and submit the HIS. patient initial assessment. and of promoting flexibility. A Commenters also stated that regulatory impact analysis (RIA) must implementing the HIS will require VI. Regulatory Impact Analysis be prepared for major rules with modifications to clinical documentation A. Statement of Need economically significant effects ($100 processes. Some commenters expressed million or more in any 1 year). This This final rule follows § 418.306(c), concerns that implementing the HIS final rule has been designated as which requires annual issuance, in the will concurrently entail both economically significant under section Federal Register, of the hospice wage implementation of a new data collection 3(f)(1)of Executive Order 12866 and tool and implementation of new quality index based on the most current thus a major rule under the measures. No commenters stated that available CMS hospital wage data. This Congressional Review Act. Accordingly, these burdens were great enough to rule finalizes hospice payment rates for we have prepared a regulatory impact consider not implementing the HIS for FY 2014. In addition, this final rule analysis (RIA) that to the best of our use in the HQRP. provides background on hospice care, ability presents the costs and benefits of Response: We recognize these clarifies diagnosis coding on hospice the rulemaking. Also, the rule has been activities and efforts will be required to claims, updates the public on the status reviewed by OMB. implement and use the HIS as part of of hospice payment reform, finalizes a the quality reporting program. We agree technical and clarifying regulatory text 2. Detailed Economic Analysis that it is important for Hospices to learn change, and finalizes changes to the This final rule sets forth updates to about and understand the new HIS and hospice quality reporting program. the FY 2013 hospice payment rates. The we plan to provide hospices with B. Overall Impact impact analysis of this final rule training resources to facilitate presents the estimated expenditure implementation of the HIS. We further The overall impact of this final rule is effects of policy changes finalized in acknowledge that specific training costs an estimated net increase in Federal this rule. Certain events may limit the were not identified in the proposed rule payments to hospices of $160 million, scope or accuracy of our impact because calculating the training burden or 1.0 percent, for FY 2014. This analysis, because such an analysis is is outside the scope of the information estimated impact on hospices is a result susceptible to forecasting errors due to collection requirements. of the final hospice payment update other changes in the forecasted impact Comment: A few commenters percentage for FY 2014 of 1.7 percent time period. The nature of the Medicare expressed concern that the estimated 29 and changes to the FY 2014 hospice program is such that the changes may minutes to complete and upload the wage index, including a reduction to the interact, and the complexity of the admission and discharge HIS was BNAF by an additional 15 percent, for interaction of these changes could make underestimated. One commenter said a total BNAF reduction of 70 percent (10 it difficult to predict accurately the full that the estimated 14 minutes for a staff percent in FY 2010, and 15 percent per scope of the impact upon hospices. member to extract data for the year for FY 2011 through FY 2014). A Table 11 represents how hospice Admission HIS and 5 minutes for the 70 percent reduced BNAF is computed revenues are likely to be affected by the Discharge HIS seemed accurate, another to be 0.018461 (or 1.8461 percent). The policy changes finalized in this rule. In commenter indicated that, based on BNAF reduction is part of a 7-year column 1 of Table 11, we indicate the their experiences with the Home Health BNAF phase-out that was finalized in number of hospices included in our OASIS, they felt the HIS would take the August 6, 2009 FY 2010 Hospice analysis as of December 31, 2012, which longer than the estimated time. Wage Index final rule (74 FR 39384), had also filed claims in FY 2012. In Response: Burden estimates for and is not a policy change. column 2, we indicate the number of completing the HIS data items were routine home care days that were 1. Introduction based on the HIS pilot test. The HIS is included in our analysis, although the a set of data elements that can be used We have examined the impacts of this analysis was performed on all types of to calculate 7 NQF endorsed quality rule as required by Executive Order hospice care. Column 3 shows the measures. The HIS is not a patient 12866 on Regulatory Planning and percentage change in estimated assessment that would be administered Review (September 30, 1993), Executive Medicare payments for FY 2014 due to to the patient and/or family or Order 13563 on Improving Regulation the effects of the updated wage data caregivers during the initial assessment and Regulatory Review (January 18, only, compared with estimated FY 2013 visits; therefore, it cannot be compared 2011), the Regulatory Flexibility Act payments. The effect of the updated to the OASIS instrument. As the HIS is (RFA) (September 19, 1980, Pub. L. 96– wage data can vary from region to region not a true patient assessment, the 354), section 1102(b) of the Act, section depending on the fluctuations in the estimated burden of 14 and 5 minutes 202 of the Unfunded Mandates Reform wage index values of the pre-floor, pre- do not include the time a clinician Act of 1995 (UMRA, March 22, 1995; reclassified hospital wage index. would spend assessing the patient. The Pub. L. 104–4), and the Congressional Column 4 shows the percentage change time estimates are intended to reflect Review Act (5 U.S.C. 804(2)). in estimated hospice payments from FY the time it would take hospice staff to Executive Orders 12866 and 13563 2013 to FY 2014 due to the combined complete and submit the HIS, direct agencies to assess all costs and effects of using the updated wage data irrespective of clinical activities to benefits of available regulatory and reducing the BNAF by an additional collect initial assessment data. The HIS alternatives and, if regulation is 15 percent. Column 5 shows the pilot demonstrated that hospices use necessary, to select regulatory percentage change in estimated hospice

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payments from FY 2013 to FY 2014 due down by urban and rural hospices. The New England. Rural hospices in every to the combined effects of using updated next grouping shows the impact on region but one are estimated to see an wage data, an additional 15 percent hospices based on the size of the increase in payments ranging from 0.4 BNAF reduction, and the final 1.7 hospice’s program. We determined that percent in New England to 1.7 percent percent hospice payment update the majority of hospice payments are in the East South Central and Outlying percentage. Taking into account the 1.7 made at the routine home care rate. region. The Pacific region is estimated percent final hospice payment update Therefore, we based the size of each to see a decrease in payments of 1.2 percentage (+$280 million), the use of individual hospice’s program on the ¥ percent, largely due to fluctuations in updated wage index data ($ 20 number of routine home care days the updated hospital wage index data million), and the additional 15 percent provided in FY 2012. The next grouping used to create the FY 2014 hospice wage reduction in the BNAF ($¥100 million), shows the impact on hospices by type index. Hospital wages in the Pacific hospice payments will increase by an of ownership. The final grouping shows estimated $160 ($280 million¥$20 the impact on hospices defined by region declined compared to the million ¥$100 million = $160 million) whether they are provider-based or previous year, which led to the decrease or 1.0 percent in FY 2014. freestanding. in the hospital wage index values, and The impact of changes in this final Column 5 of Table 11 shows the which thus affected the FY 2014 rule has been analyzed according to the combined effects of the updated wage hospice wage index values. type of hospice, geographic location, data, the additional 15 percent BNAF Column 5 of Table 11 also shows an type of ownership, hospice base, and reduction, and the final 1.7 percent estimated payment increase by hospice size. Table 11 categorizes hospices by hospice payment update percentage on base and hospice size. Payments to various geographic and hospice estimated FY 2014 payments as hospices in FY 2014 are estimated to characteristics. The first row of data compared to estimated FY 2013 increase by 1.4 percent for HHA-based displays the aggregate result of the payments. Overall, hospices are hospices, 1.1 percent for hospital-based impact for all Medicare-certified anticipated to experience a 1.0 percent hospices, 1.0 percent for SNF-based hospices. The second and third rows of increase in payment, with urban hospices, and by 0.9 percent for the table categorize hospices according hospices anticipated to experience a 1.0 to their geographic location (urban and percent increase in payments, and rural freestanding hospices. Payments to rural). Our analysis indicated that there hospices anticipated to experience 1.1 small hospices (less than 3,500 RHC are 2,594 hospices located in urban percent increase in payments. Urban days) in FY 2014 are estimated to areas and 975 hospices located in rural hospices are anticipated to experience increase by 0.8 percent, whereas areas. The next two row groupings in an increase in estimated payments in payments to large hospices (more than the table indicate the number of every region, ranging from 0.3 percent 20,000 RHC days) in FY 2014 are hospices by census region, also broken in the Mountain region to 2.2 percent in estimated to increase by 1.0 percent.

TABLE 11—ANTICIPATED IMPACT ON MEDICARE HOSPICE PAYMENTS IN FY 2014 IN UPDATING THE PRE-FLOOR, PRE-RE- CLASSIFIED HOSPITAL WAGE INDEX DATA, REDUCING THE BUDGET NEUTRALITY ADJUSTMENT FACTOR (BNAF) BY AN ADDITIONAL 15 PERCENT (FOR A TOTAL BNAF REDUCTION OF 70 PERCENT) AND APPLYING A 1.7 PERCENT HOSPICE PAYMENT UPDATE PERCENTAGE

Percent change in hos- Percent pice payments change in hos- due to wage Percent pice payments index update, Number of change in hos- due to wage additional 15% Number of routine home pice payments index update, reduction in hospices care days in due to the additional 15% budget neu- thousands wage index reduction in trality adjust- update budget neu- ment and hos- trality adjust- pice payment ment percentage update

(1) (2) (3) (4) (5)

ALL HOSPICES ...... 3,569 62,945 ¥0.1 ¥0.7 1.0 URBAN HOSPICES ...... 2,594 55,101 ¥0.1 ¥0.7 1.0 RURAL HOSPICES ...... 975 7,844 ¥0.2 ¥0.6 1.1 BY REGION—URBAN: NEW ENGLAND ...... 129 1,472 1.1 0.5 2.2 MIDDLE ATLANTIC ...... 249 5,702 0.0 ¥0.6 1.1 SOUTH ATLANTIC ...... 378 13,173 ¥0.7 ¥1.3 0.4 EAST NORTH CENTRAL ...... 338 7,224 0.0 ¥0.6 1.1 EAST SOUTH CENTRAL ...... 155 3,278 ¥0.5 ¥1.0 0.7 WEST NORTH CENTRAL ...... 197 2,494 0.4 ¥0.2 1.5 WEST SOUTH CENTRAL ...... 517 6,622 ¥0.4 ¥1.0 0.7 MOUNTAIN ...... 263 5,698 ¥0.8 ¥1.4 0.3 PACIFIC ...... 333 8,141 0.9 0.2 1.9 OUTLYING ...... 35 1,296 0.3 0.3 2.0 BY REGION—RURAL: NEW ENGLAND ...... 24 195 ¥0.7 ¥1.3 0.4 MIDDLE ATLANTIC ...... 43 439 ¥0.1 ¥0.7 1.0 SOUTH ATLANTIC ...... 135 1,918 ¥0.3 ¥0.7 1.0

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(1) (2) (3) (4) (5)

EAST NORTH CENTRAL ...... 138 1,154 0.4 ¥0.2 1.5 EAST SOUTH CENTRAL ...... 134 1,529 0.1 0.0 1.7 WEST NORTH CENTRAL ...... 182 604 ¥0.8 ¥1.2 0.5 WEST SOUTH CENTRAL ...... 176 977 ¥0.1 ¥0.2 1.5 MOUNTAIN ...... 95 568 0.4 ¥0.1 1.6 PACIFIC ...... 47 445 ¥2.2 ¥2.8 ¥1.2 OUTLYING ...... 1 15 0.0 0.0 1.7 BY SIZE/DAYS: 0–3499 DAYS (small) ...... 841 1,373 ¥0.3 ¥0.8 0.8 3500–19,999 DAYS (medium) ...... 1815 17,403 ¥0.2 ¥0.7 1.0 20,000+ DAYS (large) ...... 913 44,168 ¥0.1 ¥0.7 1.0 TYPE OF OWNERSHIP: VOLUNTARY ...... 1080 23,296 0.0 ¥0.5 1.1 PROPRIETARY ...... 2002 32,992 ¥0.3 ¥0.9 0.8 GOVERNMENT ...... 487 6,656 ¥0.1 ¥0.7 1.0 HOSPICE BASE:2 FREESTANDING ...... 2569 50,665 ¥0.2 ¥0.8 0.9 HOME HEALTH AGENCY ...... 522 7,728 0.3 ¥0.3 1.4 HOSPITAL ...... 458 4,430 0.0 ¥0.6 1.1 SKILLED NURSING FACILITY ...... 20 122 0.0 ¥0.7 1.0 Source: Provider data as of December 31, 2012 for hospices with claims filed in FY 2012 (Based on the 2012 standard analytic file (SAF). Note(s): The final 1.7 percent hospice payment update percentage for FY 2014 is based on an estimated 2.5 percent inpatient hospital market basket update, reduced by a 0.5 percentage point productivity adjustment and by 0.3 percentage point; these reductions were mandated by section 3401(g) of ACA. REGION KEY: New England = Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Middle Atlantic = Pennsylvania, New Jersey, New York; South Atlantic = Delaware, District of Columbia, Florida, Georgia, Maryland, North Carolina, South Carolina, Virginia, West Virginia; East North Central = Illinois, Indiana, Michigan, Ohio, Wisconsin; East South Central = Alabama, Kentucky, Mississippi, Tennessee; West North Central = Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota, South Dakota; West South Central = Arkansas, Louisiana, Oklahoma, Texas; Mountain = Arizona, Colorado, Idaho, Montana, Nevada, New Mexico, Utah, Wyoming; Pacific = Alaska, California, Hawaii, Oregon, Washington; Outlying = Guam, Puerto Rico, Virgin Islands

3. Cost Allocation of Quality Reporting estimated to be $14,287,929. Hospice Quality Reporting Program, for This final rule also implements a Furthermore, the structural measure a detailed discussion of these programs. related to QAPI indicators and the NQF hospice patient-level data set to be used 4. Alternatives Considered by all hospices to collect and submit #0209 pain measure will no longer be standardized data about each patient required for the hospice quality In continuing the reduction to the admitted to hospice. This Hospice Item reporting program beyond data BNAF by an additional 15 percent, for Set will be used to support the submission for the FY 2015 payment a total BNAF reduction of 70 percent (10 standardized collection and calculation determination. The original intent of the percent in FY 2010, and 15 percent per of quality measures, collection of the structural measure was for hospices to year for FY 2011 through FY 2014), and requisite data elements. Hospices will submit information about number, type, implementing the hospice payment be required to complete and submit an and data source of quality indicators update percentage and the updated admission HIS and a discharge HIS on used as a part of their QAPI Program. wage index, the aggregate impact will be all patients admitted to hospice starting Data gathered as part of the structural a net increase of $160 million in July 1, 2014 for FY 2016 APU measure were used to ascertain the payments to hospices. In the proposed determination. The admission and breadth and context of existing hospice rule for FY 2014, we did not consider discharge HIS will collect the QAPI programs to inform future discontinuing the additional 15 percent standardized data elements needed to measure development activities reduction to the BNAF as the 7-year calculate 7 NQF endorsed measures for including the data collection approach phase-out of the BNAF was finalized in hospice. The total annualized cost for the first year of required reporting the FY 2010 Hospice Wage Index final across all hospices, starting July 2014, is (FY 2014). Please refer to section B, the rule (74 FR 39384). However, if we were

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to discontinue the reduction to the TABLE 12—ACCOUNTING STATEMENT: has a significant impact on a substantial BNAF by an additional 15 percent, CLASSIFICATION OF ESTIMATED EX- number of small entities (for example, Medicare would pay an estimated $100 PENDITURES, FROM FY 2013 TO FY hospices). We estimate that 95 percent million more to hospices in FY 2014. 2014 of hospices have Medicare revenues below $14 million or are nonprofit The final 1.7 percent hospice payment [In $millions] update percentage for FY 2014 is based organizations and therefore are considered small entities. on a final 2.5 percent inpatient hospital Category Transfers market basket update for FY 2014, HHS’s practice in interpreting the RFA is to consider effects economically reduced by a 0.5 percentage point Annualized Monetized $160. ‘‘significant’’ only if they reach a productivity adjustment and by an Transfers. threshold of 3 to 5 percent or more of additional 0.3 percentage point. From Whom to Whom Federal Government to Hospices. total revenue or total costs. As noted Payment rates for FYs since 2002 have above, the combined effect of the been updated according to section Category Costs updated wage data, the additional 15 1814(i)(1)(C)(ii)(VII) of the Act, which percent BNAF reduction, and the final states that the update to the payment Annualized Monetized $14.3. FY 2014 hospice payment update rates for subsequent FYs must be the Costs for Hospices to Submit Data*. percentage of 1.7 percent results in an market basket percentage for that FY. increase in estimated hospice payments The Act requires us to use the inpatient * All hospices are required to submit data for of 1.0 percent for FY 2014. For small hospital market basket to determine the the Hospice Item Set starting in July of 2014. and medium hospices (as defined by hospice payment rate update. In D. Conclusion routine home care days), the estimated addition, section 3401(g) of the effects on revenue when accounting for In conclusion, the overall effect of this Affordable Care Act mandates that, the updated wage data, the additional final rule is an estimated $160 million 15 percent BNAF reduction, and the starting with FY 2013 (and in increase in Federal Medicare payments subsequent FYs), the hospice payment final FY 2014 hospice payment update to hospices due to the wage index percentage reflect increases in payments update percentage will be annually changes (including the additional 15 reduced by changes in economy-wide of 0.8 percent and 1.0 percent, percent reduction in the BNAF) and the respectively. Therefore, the Secretary productivity as specified in section final hospice payment update 1886(b)(3)(B)(xi)(II) of the Act. In has determined that this final rule will percentage of 1.7 percent. Furthermore, not create a significant economic impact addition, section 3401(g) of the hospices are estimated to incur total on a substantial number of small Affordable Care Act also mandates that costs of $14.3 million as a result of data entities. in FY 2013 through FY 2019, the submission requirements starting in July In addition, section 1102(b) of the Act hospice payment update percentage will 2014. Lastly, the Secretary has requires us to prepare a regulatory be reduced by an additional 0.3 determined that this final rule will not impact analysis if a rule may have a percentage point (although for FY 2014 have a significant impact on a significant impact on the operations of to FY 2019, the potential 0.3 percentage substantial number of small entities, or a substantial number of small rural point reduction is subject to suspension have a significant effect relative to hospitals. This analysis must conform to under conditions specified in section section 1102(b) of the Act. the provisions of section 604 of the 1814(i)(1)(C)(v) of the Act). Since the 1. Regulatory Flexibility Act Analysis RFA. For purposes of section 1102(b) of hospice payment update percentage is the Act, we define a small rural hospital determined based on statutory The RFA requires agencies to analyze as a hospital that is located outside of options for regulatory relief of small requirements, we did not consider not a metropolitan statistical area and has businesses if a rule has a significant updating hospice payment rates by the fewer than 100 beds. This final rule only impact on a substantial number of small payment update percentage. affects hospices. Therefore, the entities. For purposes of the RFA, we Secretary has determined that this final C. Accounting Statement estimate that almost all hospices are rule will not have a significant impact small entities as that term is used in the on the operations of a substantial As required by OMB Circular A–4 RFA. The great majority of hospitals and number of small rural hospitals. (available at http:// most other health care providers and www.whitehouse.gov/omb/circulars/ suppliers are small entities by meeting 2. Unfunded Mandates Reform Act a004/a-4.pdf), in Table 12 below, we the Small Business Administration Analysis have prepared an accounting statement (SBA) definition of a small business (in Section 202 of the Unfunded showing the classification of the the service sector, having revenues of Mandates Reform Act of 1995 also expenditures associated with this final less than $7.0 million to $34.5 million requires that agencies assess anticipated rule. Table 12 provides our best estimate in any 1 year), or being nonprofit costs and benefits before issuing any of the increase in FY 2014 Medicare organizations. While the SBA does not rule whose mandates require spending payments under the hospice benefit as define a size threshold in terms of in any 1 year of $100 million in 1995 a result of the changes presented in this annual revenues for hospices, it does dollars, updated annually for inflation. final rule using data for 3,569 hospices define one for home health agencies In 2013, that threshold is approximately in our database. In addition, the table ($14 million; see http://www.sba.gov/ $141 million. This final rule is not sites/default/files/files/ anticipated to have an effect on State, presents the costs to hospice providers _ _ for submitting data to the Hospice Item Size Standards Table(1).pdf). For the local, or tribal governments, in the purposes of this final rule, because the Set starting in July 2014. aggregate, or on the private sector of hospice benefit is a home-based benefit, $141 million or more. we are applying the SBA definition of Comment: We received a few ‘‘small’’ for home health agencies to comments on Unfunded Mandates hospices; we will use this definition of Reform Act Analysis section. ‘‘small’’ in determining if this final rule Commenters disagreed that we did not

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meet the statutory threshold of the as indicated in section V of this final List of Subjects in 42 CFR Part 418 Unfunded Mandates Reform Act of rule, we set out the requirements and 1995. A commenter stated that the total burden estimates for the Hospice Health facilities, Hospice care, costs of additional staff time, Experience of Care Survey field study Medicare, Reporting and recordkeeping professional consulting fees and and indicated that it is too early to set requirements. software necessary to comply fully with out the requirements and burden For the reasons set forth in the the new billing; coding, quality estimates for the national preamble, the Centers for Medicare & reporting and survey administration implementation of the survey. We Medicaid Services proposes to amend tasks will exceed that threshold figure of anticipate having the final survey 42 CFR part 418 as set forth below: $141 million. instrument in 2014 and setting out the Response: The hospice benefit covers collection of information requirements PART 418—HOSPICE CARE all care for the terminal prognosis, and burden estimates in the proposed related conditions, and for the rule for CY 2015. In addition, we ■ 1. The authority citation for part 418 management of pain and symptoms. provided a burden estimate for the continues to read as follows: HIPAA, federal regulations, and the Hospice Item Set that providers will be Medicare hospice claims processing required to submit starting FY 2015, Authority: Secs. 1102 and 1871 of the manual all require that ICD–9–CM with a total annualized cost across all Social Security Act (42 U.S.C. 1302 and Coding Guidelines be applied to the hospices estimated at $14,287,929. 1395hh). coding and reporting of diagnoses on Therefore, we do not believe that any § 418.311 [Amended] hospice claims. In our regulations at 45 clarifications or requirements CFR 162.1002, the Secretary adopted the promulgated in this rule exceed the ■ 2. Amend § 418.311 by removing the ICD–9–CM code set, including The Unfunded Mandates Reform Act reference to ‘‘§ 405.1874’’ and adding in Official ICD–9–CM Guidelines for threshold. its place the reference ‘‘§ 405.1875’’. Coding and Reporting. The CMS’ (Catalog of Federal Domestic Assistance Hospice Claims Processing manual (Pub VII. Federalism Analysis and Regulations Text Program No. 93.778, Medical Assistance 100–04, chapter 11) requires that Program) (Catalog of Federal Domestic hospice claims include other diagnoses Executive Order 13132 on Federalism Assistance Program No. 93.773, Medicare— ‘‘as required by ICD–9–CM Coding (August 4, 1999) establishes certain Hospital Insurance; and Program No. 93.774, Guidelines.’’ In the proposed rule, we requirements that an agency must meet Medicare—Supplementary Medical provided guidance from the ICD–9–CM when it promulgates a proposed rule Insurance Program) Official Guidelines for Coding and (and subsequent final rule) that imposes Dated: July 24, 2013. substantial direct requirement costs on Reporting to highlight coding guidelines Marilyn Tavenner, for principal and other diagnosis State and local governments, preempts selection, as well as the various coding State law, or otherwise has Federalism Administrator, Centers for Medicare & Medicaid Services. and sequencing conventions found implications. We have reviewed this therein. We are not requiring any new final rule under the threshold criteria of Approved: July 30, 2013. ICD–9–CM coding guidelines in this Executive Order 13132, Federalism, and Kathleen Sebelius, rule, rather we are reiterating existing have determined that it will not have Secretary, Department of Health and Human policies and reminding providers of the substantial direct effects on the rights, Services. expectations in regards to diagnostic roles, and responsibilities of States, [FR Doc. 2013–18838 Filed 8–2–13; 4:15 pm] coding on hospice claims. In addition, local or tribal governments. BILLING CODE 4120–01–P

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Reader Aids Federal Register Vol. 78, No. 152 Wednesday, August 7, 2013

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