Vol. 77 Friday, No. 218 November 9, 2012

Pages 67239–67532

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 77, No. 218

Friday, November 9, 2012

Agricultural Marketing Service Defense Department RULES NOTICES National Organic Program: Agency Information Collection Activities; Proposals, Periodic Residue Testing, 67239–67251 Submissions, and Approvals Federal Acquisition Regulation; Quality Assurance Agriculture Department Requirements, 67366–67367 See Agricultural Marketing Service Federal Acquisition Regulation; Travel Costs, 67366 See Farm Service Agency Environmental Impact Statements; Availability, etc.: See Forest Service Clearwater Program, 67345 See National Institute of Food and Agriculture Drug Enforcement Administration Alcohol and Tobacco Tax and Trade Bureau NOTICES NOTICES Importers of Controlled Substances; Applications: Agency Information Collection Activities; Proposals, Fisher Clinical Services, Inc., 67396–67397 Submissions, and Approvals, 67442–67447 Importers of Controlled Substances; Registrations: Boehringer Ingelheim Chemicals, Inc., 67397 Blind or Severely Disabled, Committee for Purchase From Manufacturers of Controlled Substances; Applications: People Who Are Cody Laboratories, Inc., 67398 See Committee for Purchase From People Who Are Blind or INB Hauser Pharmaceutical Services, Inc., 67398–67399 Severely Disabled Johnson Matthey, Inc., 67397–67398 National Center for Natural Products Research, 67398 Census Bureau Noramco, Inc., 67397 NOTICES Annual Wholesale Trade Survey, 67331–67332 Education Department NOTICES Centers for Medicare & Medicaid Services Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals: Medicare Program: 2013–2014 Federal Student Aid Application, 67345– End-Stage Renal Disease Prospective Payment System, 67348 Quality Incentive Program, and Bad Debt Reductions Privacy Act; Systems of Records, 67348–67352 for all Medicare Providers, 67450–67531 Employment and Training Administration NOTICES Medicare and Medicaid Programs: NOTICES Quarterly Listing of Program Issuances, 67368–67379 Certifications Regarding Eligibility to Apply for Worker Adjustment Assistance: Coast Guard Hewlett–Packard Co., Corvallis, OR and Vancouver, WA, 67399–67400 PROPOSED RULES Drawbridge Operations: RG Steel Wheeling, LLC, Beech Bottom, WV, 67400 Lake Champlain, Swanton, VT, 67319–67322 State Street Corp., Quincy, MA, 67399 Trim Systems Operating Corp., Statesville, NC, 67399 Commerce Department Determinations Regarding Eligibility to Apply for Worker Adjustment Assistance, 67400–67406 See Census Bureau Investigations Regarding Eligibility to Apply for Worker See International Trade Administration Adjustment Assistance, 67406–67407 See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration Energy Department See National Telecommunications and Information See Federal Energy Regulatory Commission Administration Environmental Protection Agency Committee for Purchase From People Who Are Blind or RULES Severely Disabled Dinotefuran; Pesticide Tolerances for Emergency NOTICES Exemptions, 67282–67285 Procurement List; Additions and Deletions, 67343–67344 PROPOSED RULES Revisions to the California State Implementation Plan: Consumer Product Safety Commission Placer County Air Pollution Control District, 67322– NOTICES 67324 Meetings; Sunshine Act, 67344 NOTICES Agency Information Collection Activities; Proposals, Corporation for National and Community Service Submissions, and Approvals: NOTICES Inform Hydraulic Fracturing Research Related to Drinking Agency Information Collection Activities; Proposals, Water Resources, 67361–67362 Submissions, and Approvals, 67344–67345 Environmental Impact Statements; Availability, etc., 67362

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Export–Import Bank MP2 Energy IL LLC, 67359–67360 NOTICES MP2 Energy NJ LLC, 67360 Applications for Final Commitments for Long-Term Loans Preliminary Permit Applications: or Financial Guarantees in Excess of $100 million, Igiugig Village Council, 67360–67361 67362–67363 Meetings; Sunshine Act, 67363 Federal Maritime Commission NOTICES Farm Service Agency Agreements Filed, 67365 NOTICES Agency Information Collection Activities; Proposals, Federal Reserve System Submissions, and Approvals: NOTICES Agricultural Foreign Investment Disclosure Act, 67329 Changes in Bank Control: Servicing Minor Program Loans, 67329–67330 Acquisitions of Shares of a Bank or Bank Holding Company, 67365–67366 Federal Aviation Administration RULES Federal Transit Administration Airworthiness Directives: NOTICES Aeronautical Accessories, Inc., High Landing Gear Fiscal Year 2013 Public Transportation on Indian Forward Crosstube Assembly, 67261–67263 Reservations Program, 67439–67442 Airbus Airplanes, 67256–67261, 67263–67267 Bombardier, Inc. Airplanes, 67254–67256, 67267–67269 Fish and Wildlife Service Special Conditions: RULES Boeing Model 757 Series Airplanes; Seats with Non- Endangered and Threatened Wildlife and Plants: Traditional, Large, Non-Metallic Panels, 67251–67254 Termination of the Southern Sea Otter Translocation Voluntary Licensing of Amateur Rocket Operations; Program; Final Supplemental Environmental Impact Withdrawal, 67269–67270 Statement, 67302–67303 PROPOSED RULES NOTICES Special Conditions: Meetings: Embraer S.A., Model EMB–550 Airplane; Hydrophobic Conference of the Parties to the Convention on Coatings in Lieu of Windshield Wipers, 67308–67309 International Trade in Endangered Species of Wild Embraer S.A., Model EMB–550 Airplanes; Flight Fauna and Flora, 67390–67391 Envelope Protection: Performance Credit for Automatic Takeoff Thrust Control System (ATTCS) Food and Drug Administration During Go-Around, 67309–67313 NOTICES NOTICES Draft Guidance for Industry and Staff; Availability: Petitions for Exemptions; Summaries of Petitions Received, Highly Multiplexed Microbiological/Medical 67438–67439 Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices, 67379–67380 Federal Communications Commission Meetings: RULES Anesthetic and Analgesic Drug Products Advisory Basic Service Tier Encryption Compatibility Between Cable Committee, 67380 Systems and Consumer Electronics Equipment, 67290– 67302 Foreign Assets Control Office NOTICES RULES Suspensions and Commencements of Proposed Debarment Yemen Sanctions Regulations, 67276–67282 Proceedings: Schools and Libraries Universal Service Support Forest Service Mechanism, 67363–67365 NOTICES Meetings: Federal Emergency Management Agency Sitka Resource Advisory Committee, 67330 RULES Debris Removal: General Services Administration Eligibility of Force Account Labor Straight-Time Costs NOTICES under the Public Assistance Program for Hurricane Agency Information Collection Activities; Proposals, Sandy, 67285–67290 Submissions, and Approvals PROPOSED RULES Federal Acquisition Regulation; Quality Assurance Flood Elevation Determinations; Correction, 67324–67327 Requirements, 67366–67367 Federal Acquisition Regulation; Travel Costs, 67366 Federal Energy Regulatory Commission NOTICES Health and Human Services Department Applications: See Centers for Medicare & Medicaid Services City of New York, 67352 See Food and Drug Administration Lock+ Hydro Friends Fund XLII, LLC, 67352–67353 See National Institutes of Health Combined Filings, 67353–67359 NOTICES Environmental Assessments; Availability, etc.: Physical Activity Guidelines Mid-course Report; Wickiup Hydro Group, LLC, 67359 Availability, 67367–67368 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Homeland Security Department EnergyMark, LLC, 67360 See Coast Guard

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See Federal Emergency Management Agency National Institute of Standards and Technology NOTICES Housing and Urban Development Department National Fire Codes: NOTICES Request for Comments on NFPA’s Codes and Standards, Announcement of Funding Awards: 67340–67341 Indian Community Development Block Grant Program; Fiscal Year 2012, 67386–67389 Federal Properties Suitable as Facilities to Assist Homeless, National Institutes of Health 67389 NOTICES Agency Information Collection Activities; Proposals, Interior Department Submissions, and Approvals: See Fish and Wildlife Service Ethical Dilemmas in Surgery and Utilization of Hospital See Land Management Bureau Ethics Consultation Service; A Survey, 67380–67381 See Ocean Energy Management Bureau Government-Owned Inventions; Availability for Licensing, 67381–67385 International Trade Administration Meetings: NOTICES Center for Scientific Review, 67385 Antidumping Duty Administrative Reviews; Results, National Human Genome Research Institute, 67385 Extensions, Amendments, etc.: National Institute of Allergy and Infectious Diseases, Certain Small Diameter Carbon and Alloy Seamless 67385–67386 Standard, Line and Pressure Pipe from Romania, National Institute of General Medical Sciences, 67385 67336–67337 Certain Steel Threaded Rod from the People’s Republic of China, 67332–67334 National Oceanic and Atmospheric Administration Frontseating Service Valves from the People’s Republic of RULES China, 67334–67336 Fisheries of the Caribbean, Gulf of Mexico, and South Final Results of Antidumping Duty Administrative Review: Atlantic: Certain Activated Carbon from the People’s Republic of Reef Fish Fishery of the Gulf of Mexico; Gray Triggerfish China, 67337–67340 Management Measures, 67303–67305 Fisheries of the Northeastern United States: International Trade Commission Atlantic Mackerel, Squid, and Butterfish Fisheries; NOTICES Specifications and Management Measures, 67305– Investigations: 67307 Corrosion-Resistant Carbon Steel Flat Products From PROPOSED RULES Germany And Korea, 67395 Fisheries Off West Coast States: Meetings; Sunshine Act, 67396 West Coast Salmon Fisheries, Amendment 17 to the Salmon Fishery Management Plan; Availability, Justice Department 67327–67328 See Drug Enforcement Administration NOTICES NOTICES Applications: Lodgings of Proposed Consent Decrees under CERCLA, Endangered Species; File No. 15809, 67341 67396 Meetings: Fisheries of the South Atlantic; Southeast Data, Labor Department Assessment and Review, 67341–67342 See Employment and Training Administration North Pacific Fishery Management Council, 67342 See Occupational Safety and Health Administration National Science Foundation Land Management Bureau NOTICES NOTICES Plats of Surveys: Antarctic Conservation Act Permit Applications, 67407 Eastern States; Mississippi, 67391 Antarctic Conservation Act Permits, 67407–67408 Public Land in Water Canyon, Humboldt County, NV, 67391–67394 National Telecommunications and Information Administration National Aeronautics and Space Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals First Responder Network Authority Board, 67342–67343 Federal Acquisition Regulation; Quality Assurance Requirements, 67366–67367 Federal Acquisition Regulation; Travel Costs, 67366 Occupational Safety and Health Administration RULES National Institute of Food and Agriculture Exemption for Digger Derricks in Cranes and Derricks in NOTICES Construction Standard, 67270–67276 Requests for Stakeholder Input: PROPOSED RULES Veterinary Medicine Loan Repayment Program, 67330– Exemption for Digger Derricks in Cranes and Derricks in 67331 Construction Standard, 67313–67319

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Ocean Energy Management Bureau Surface Transportation Board NOTICES NOTICES Oil and Gas Lease Sales: Temporary Trackage Rights Exemptions: Gulf of Mexico, Outer Continental Shelf; Western Northern Plains Railroad, Inc. from Soo Line Railroad Planning Area 233 and Central Planning Area 231, Co., 67442 67394–67395 Soo Line Railroad Co. by BNSF Railway Co., 67442

Securities and Exchange Commission Transportation Department NOTICES See Federal Aviation Administration Meetings; Sunshine Act, 67408 See Federal Transit Administration Self-Regulatory Organizations; Proposed Rule Changes: See Surface Transportation Board C2 Options Exchange, Inc., 67424–67427 Chicago Board Options Exchange, Inc., 67421–67424 Treasury Department ICE Clear Europe Limited, 67427–67429 See Alcohol and Tobacco Tax and Trade Bureau NASDAQ Stock Market LLC, 67409–67410 See Foreign Assets Control Office National Securities Clearing Corp., 67410–67412 New York Stock Exchange LLC, 67431–67433 NYSE Arca, Inc., 67412–67418 Separate Parts In This Issue NYSE MKT LLC, 67419–67420 Options Clearing Corp., 67429–67431 Part II Health and Human Services Department, Centers for Small Business Administration Medicare & Medicaid Services, 67450–67531 NOTICES Community Advantage Pilot Program, 67433–67435

Social Security Administration Reader Aids NOTICES Consult the Reader Aids section at the end of this page for Agency Information Collection Activities; Proposals, phone numbers, online resources, finding aids, reminders, Submissions, and Approvals, 67435–67438 and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents State Department LISTSERV electronic mailing list, go to http:// NOTICES listserv.access.gpo.gov and select Online mailing list Meetings: archives, FEDREGTOC-L, Join or leave the list (or change Defense Trade Advisory Group, 67438 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.

7 CFR 205...... 67239 14 CFR 25...... 67251 39 (5 documents) ...... 67254, 67256, 67261, 67263, 67267 400...... 67269 Proposed Rules: 25 (2 documents) ...... 67308, 67309 29 CFR 1926...... 67270 Proposed Rules: 1926...... 67313 31 CFR 552...... 67276 33 CFR Proposed Rules: 117...... 67319 40 CFR 180...... 67282 Proposed Rules: 52...... 67322 42 CFR 413...... 67450 417...... 67450 44 CFR 206...... 67285 Proposed Rules: 67 (2 documents) ...... 67324, 67325 47 CFR 76...... 67290 50 CFR 17...... 67302 622...... 67303 648...... 67305 Proposed Rules: 660...... 67327

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Rules and Regulations Federal Register Vol. 77, No. 218

Friday, November 9, 2012

This section of the FEDERAL REGISTER Standards Division, Telephone: (202) the OFPA, accredited certifying agents contains regulatory documents having general 720–3252; Fax: (202) 205–7808. are required to conduct residue testing applicability and legal effect, most of which SUPPLEMENTARY INFORMATION: of organic products on a regular and are keyed to and codified in the Code of reoccurring basis, as well as when there Federal Regulations, which is published under I. Background is reason to believe contamination has 50 titles pursuant to 44 U.S.C. 1510. Under section 6511 of the Organic occurred, and that the regulations be The Code of Federal Regulations is sold by Foods Production Act of 1990 (OFPA), revised as provided for in this the Superintendent of Documents. Prices of as amended, (7 U.S.C. 6501–6522), the rulemaking. new books are listed in the first FEDERAL National Organic Program (NOP) is On June 23 and June 24, 2010, the REGISTER issue of each week. authorized to implement regulations NOP conducted two webinar trainings that require accredited certifying agents with certifying agents on periodic to conduct residue testing of organically residue testing under the NOP. The DEPARTMENT OF AGRICULTURE produced agricultural products. Section objective of the webinar was to present 6506 of the OFPA also requires that the an overview of requirements for Agricultural Marketing Service NOP include provisions for periodic periodic residue testing under the OFPA residue testing by certifying agents of and the NOP. The NOP also solicited 7 CFR Part 205 agricultural products produced or feedback from the certifying agents who [Document Number AMS–NOP–10–0102; handled in accordance with the NOP. participated in the webinar. Of the NOP–10–10FR] Residue testing plays an important certifying agents accredited at that time, role in organic certification by providing 55 individuals registered to participate RIN 0581–AD10 a means for monitoring compliance with in the webinar. Ten participants in the National Organic Program; Periodic the NOP and by discouraging the webinar provided written feedback to Residue Testing mislabeling of agricultural products. the NOP in response to the information Testing of organically produced provided. These comments were AGENCY: Agricultural Marketing Service, agricultural products is promulgated in considered in the development of this USDA. section 205.670 of the NOP regulations final rule. ACTION: Final rule. (7 CFR part 205). This section provides On April 29, 2011, AMS published a that the Secretary, State organic proposed rule for periodic residue SUMMARY: This final rule clarifies a programs, and certifying agents may testing (76 FR 23914). The rule provision of the Organic Foods require preharvest or postharvest testing proposed that certifying agents, on an Production Act of 1990 and the of any agricultural input used or annual basis, must sample and conduct regulations issued thereunder that agricultural product to be sold, labeled, residue testing from a minimum of five requires periodic residue testing of or represented as ‘‘100 percent organic,’’ percent of the operations that they organically produced agricultural ‘‘organic,’’ or ‘‘made with organic certify. The proposed rule included a 60 products by accredited certifying agents. (specified ingredients or food group(s))’’ day comment period. Comments were The final rule amends the U.S. when there is reason to believe that the also specifically requested on the Department of Agriculture’s (USDA) agricultural input or product has come information collection burden that National Organic Program (NOP) into contact with a prohibited substance would result from the proposed action. regulations to make clear that accredited or has been produced using excluded The NOP received over 30 written certifying agents must conduct periodic methods. comments in response to the proposed residue testing of agricultural products The Agricultural Marketing Service rule. that are to be sold, labeled, or (AMS) is issuing this final rule in II. Comments on Proposed Rule represented as ‘‘100 percent organic,’’ response to an audit of the NOP which Comments in response to the ‘‘organic,’’ or ‘‘made with organic was conducted in March 2010 by the proposed rule were received from (specified ingredients or food USDA Office of Inspector General certified organic operations, certifying group(s)).’’ The final rule expands the (OIG).1 As part of the audit, the OIG agents, consumers, trade associations, amount of residue testing of organically visited four certifying agents accredited organic associations, and various produced agricultural products by by the NOP. The audit found that none clarifying that sampling and testing are industry groups. of the four certifying agents visited The majority of commenters required on a regular basis. The final conducted periodic residue testing. The supported residue testing in general, rule requires that certifying agents, on OIG indicated that these certifying and offered comments regarding the role an annual basis, sample and conduct agents noted that they considered of the National Organic Standards Board residue testing from a minimum of five residue testing to be required by the (NOSB), sampling rates, sample percent of the operations that they regulations only under certain selection, costs and costs estimates, certify. This action will help further circumstances. testing methodology, data collection, ensure the integrity of products AMS conducted a review of this issue and reporting requirements. produced and handled under the NOP in response to the OIG audit. AMS Four comments specifically addressed regulations. concluded that, under section 6506 of the information collection and DATES: Effective Date: This final rule is recordkeeping requirements of this effective January 1, 2013. 1 U.S. Department of Agriculture, Office of Inspector General, Audit Report 01601–03-Hy, action pursuant to the Paperwork FOR FURTHER INFORMATION CONTACT: March 2010. Available at http://www.usda.gov/oig/ Reduction Act (44 U.S.C. 3501–3520) Melissa R. Bailey, Ph.D., Director, webdocs/01601-03-HY.pdf. (PRA).

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AMS received one comment from a under section 205.2 of the NOP The NOP accepts the majority of the certifying agent requesting an extension regulations as background levels of commenters’ suggestions to include all of the comment period. Since the naturally occurring or synthetic testing towards the minimum proposed rule included a 60 day chemicals that are present in the soil or requirement. Any residue testing comment period and because the NOP present in organically produced performed by a certifying agent may be previously conducted two webinar agricultural products that are below counted towards the minimum trainings with certifying agents on established tolerances. This rule does requirement for residue testing, periodic residue testing on June 23 and not amend this existing definition. provided that the certifying agent June 24, 2010, we did not agree that an samples and tests from a minimum of extension of the comment period was Number of Samples five percent of the operations it certifies warranted. AMS received twelve comments on on an annual basis. AMS received two comments Authority To Issue Rule the issue of the amount of sampling or number of samples. The proposed rule requesting a phase-in period for the Seven commenters indicated that they indicated that certifying agents would testing requirements. One commenter did not believe that AMS has the be required, on an annual basis, to suggested testing a portion of the five authority to issue a rule on residue sample and conduct residue testing percent minimum percentage of testing under the OFPA without a from a minimum of five percent of the operations in 2012, and the full recommendation from the NOSB. operations that they certify. The percentage of operations in 2013. The The NOSB is a federal advisory proposed rule indicated that residue commenter noted that a phase-in would committee established by the Secretary testing conducted for causative reasons, enable certification agents to plan of Agriculture under section 6518 of the such as complaint-driven testing, or budgets, develop office procedures, and OFPA to assist in the development of testing when there was reason to train staff and inspectors. The standards for substances to be used in suspect contamination, would not be commenter also noted that a phase-in organic production and to advise the would enable the NOP to assess the Secretary on other aspects of the counted towards the minimum percentage required. effectiveness of the testing program. implementation of the NOP. AMS received one comment requesting The commenters cited section 6518 of Based on the comments received, a phase-in of three percent for the first the OFPA which states ‘‘the Board shall AMS believes that using a percentage of two years, which could be reevaluated advise the Secretary concerning the certified operations to determine sample and adjusted accordingly in the future. testing of organically produced selection offers the simplest AMS has considered the commenters’ agricultural products for residues implementation for certifying agents suggestion for a phase-in of the caused by unavoidable residual and ensures that all certifying agents implementation and compliance date of environmental contamination.’’ conduct a minimal level of residue the final rule and has issued this final Additionally, two commenters cited a testing. Further discussion of the rule with an effective date of January 1, 1990 report of the U.S. Senate comments received is provided below. 2013. Certifying agents must be fully Committee on Agriculture, Nutrition, Number of Samples—Changes Based on compliant with the five percent and Forestry, which indicates that the Comments requirement for the 2013 calendar year. NOSB would be most knowledgeable on The NOP understands that a minority of the subject of levels of acceptable AMS received five comments accredited certifying agents currently residues of prohibited materials for requesting that all residue testing conduct residue testing on a regular, organic food, and that the Committee conducted by a certifying agent be periodic basis. However, the NOP notes intends that the NOSB shall advise the counted towards the five percent that certifying agents are already Secretary concerning appropriate minimum requirement, including required, under section 205.504(b)(6) of residue levels and testing methods for compliance testing, investigative testing, the NOP regulations, to have procedures organic products.2 risk-based sampling, and random and trained staff in place for AMS disagrees with the commenters’ sampling. One commenter indicated investigations of pesticide drift, claims that AMS does not have the that establishing random testing at five complaints, or when reason to believe a authority to issue a rule in this area. percent would make it more difficult to product has come into contact with a This final rule is issued under the do other types of testing (e.g. risk-based, prohibited substances. As evidence of authority of the OFPA at section compliance testing) because of the costs their expertise and ability, certifying 6506(a)(6) which requires periodic involved. Several commenters indicated agents are also already required to residue testing by certifying agents. This that compliance, investigative, and risk- submit a copy of the procedures to be rule does not amend any provisions or based testing would yield more used for sampling and residue testing thresholds related to the maximum meaningful results than random testing. pursuant to section 205.670 as an allowable pesticide residue for organic One comment from a certifying agent accreditation requirement. food or thresholds related to indicated that it did not support unavoidable residual environmental Number of Samples—Changes revising the rule to include compliance Requested But Not Made contamination (UREC). The existing or investigative testing as part of the five NOP regulations regarding UREC at percent requirement. Based on One commenter noted that the section 205.671 were based on a experience in taking samples for both number of operations that would be recommendation adopted by the NOSB purposes, the commenter indicated that sampled under the proposed rule was at its meeting June 1–4, 1994 in Santa the concern from certifying agents that small relative to the total number of 3 Fe, New Mexico. UREC is defined the proposed rule would be a operations. The commenter noted that disincentive to conduct compliance or sampling based on the number of 2 U.S. Senate, Committee on Agriculture, investigative testing was unfounded. operations does not account for Nutrition, and Forestry. Food, Agriculture, differences in sizes of the operations, Conservation, and Trade Act of 1990, S. Rpt. 101– 357 to accompany S. 2830, July 6, 1990. Available on the NOP Web site at http:// and suggested that sampling be based 3 National Organic Standards Board, Final www.ams.usda.gov/AMSv1.0/ upon size and quantity, rather than the Recommendations, Residue Testing, 1994. getfile?dDocName=stelprdc5058863. number of operations. The commenter

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suggested that AMS have an unbiased objectives of implementing periodic select operations at random. AMS is not group determine sampling methodology residue testing as required by OFPA. specifying how certifying agents should using proper scientific and statistical Additional details on the costs, benefits, select operations for residue testing in techniques. The commenter noted that, and alternatives considered are order to provide flexibility to the unless AMS uses a sound basis in discussed in the section titled Executive certifying agency. Instead, AMS is choosing the number, size, and site of Order 12866 and Executive Order providing discretion to the certifying the samples, any conclusions drawn 13563. agent to select operations. Operation from the testing would be invalid. AMS notes that lowering the selection for residue testing may include Another commenter suggested that percentage below five percent does not risk factors such as number of products AMS should require sampling based on have an impact on the smallest quartile produced, split operations, size of the a percentage of products, rather than a of certifying agents that certify fewer operation, high-value or high-risk crops, percentage of operations. than thirty operations to the NOP per or other criteria deemed appropriate by Two comments indicated that the five year, since they are required to sample the certifying agent. percent number was arbitrary and not a minimum of one operation under Three commenters indicated that statistically valid, but did not offer an either scenario. certifying agents should not select the alternative method for determining One comment from a consumer group operations for residue testing since this sampling size. indicated that AMS should reserve the may be an inherent conflict of interest. AMS disagrees. Basing sampling on a right to raise the percentage for a Commenters suggested that the NOP or percentage of operations reduces the specific certifying agent if residue other third-party groups select the burden on the certifying agents by testing shows that a certifying agent has operations. AMS disagrees. Certifying providing a clear and simple formula for an unusually high number of positive agents are already required to how to comply with the regulations. results. AMS believes that the implement procedures to prevent The five percent requirement satisfies regulations provide sufficient flexibility conflict of interests as a condition of AMS’s intent to discourage the for the NOP to address issues that may accreditation under the NOP regulations mislabeling of agricultural products and arise on a case-by-case basis, and (§ 205.501(a)(11)). AMS also conducts provide a means for monitoring therefore, no modifications are regular audits of certifying agents to compliance with the NOP. necessary to the regulations. ensure compliance with NOP Under the final rule, certifying agents One commenter requested that AMS accreditation requirements including have the discretion to select operations review the residue testing data in five preventing conflicts of interest. AMS for residue testing based on criteria such years to see if the percentage of does not have reason to believe that as size of operation, quantity of operations tested could be reduced. selection of operations for purposes of products produced, previous AMS notes that the final rule does not periodic residue testing would be compliance issues, or other risk factors. prohibit AMS from reconsidering the different from any other certification Certifying agents are knowledgeable percentage of operations required for work carried out by certifying agents about the risk factors affecting the compliance at a later date based on new with respect to conflict of interest. operations it certifies; therefore, it is information, but this would be under a Several commenters suggested appropriate for a certifying agent to separate rulemaking action. utilizing a system of statistical sampling determine what operations should be AMS received one comment from a methods for operation selection, such as tested under this action. certifying agent regarding the role of that used by the AMS Pesticide Data AMS received three comments State organic programs under the Program. AMS disagrees. It is not AMS’ requesting that AMS lower the proposed rule. AMS currently has one intent to assemble data and draw minimum percentage of operations to be State organic program in California. The conclusions based on statistical tested from five percent to three percent commenter requested that testing sampling techniques, as the sampling due to costs. One of the commenters conducted by a State program should performed by certifying agents will vary stated that the costs of testing would be offset the certifying agents’ requirement considerably due to the worldwide passed on indirectly to farmers and in that State. AMS disagrees. Under the diversity of operations which are processors in the form of higher OFPA, certifying agents are required to certified to the NOP. Certifying agents certification fees. Another commenter conduct residue testing. AMS believes have the discretion to sample from stated that requiring three percent, that requiring certifying agents to test higher risk operations, which may yield rather than five percent, would allow from five percent of certified operations results that are not representative of all the certifying agent more latitude for on an annual basis is reasonable, and organic operations. doing risk-based and compliance that testing conducted by other sampling. organizations, including State organic Types of Samples—Changes Based on In the final rule, AMS allows for both programs or other private testing Comments periodic testing and compliance programs, should not offset this AMS received eight comments sampling to be counted towards the requirement under the OFPA. regarding the selection of samples for minimum requirement, but has retained residue testing. The commenters the minimum percentage of operations Operation Selection and Conflict of requested changes in the rule to clarify to be tested at five percent annually. Interest—Changes Requested But Not that residue sampling may be performed AMS has considered the comment Made on samples which are not finished that this action may indirectly increase AMS received nine comments products, such as soil samples, tissue costs to certified operations if certifying regarding the selection of operations for samples, or water. agents increase their certification fees to residue testing. Several commenters Commenters noted that preharvest recover costs from increased residue requested clarification on selection of sampling may be more meaningful testing. This action implements periodic operations and whether it is AMS’ when sampling is risk-based or for residue testing in a way that should intent to have certifying agents select investigative testing (e.g., when use of a minimize the direct costs to certifying operations at random or use other prohibited substance is suspected). In agents and any indirect costs to certified criteria. It is not AMS’ intent for this addition, commenters suggested that operations while still meeting the final rule to require certifying agents to preharvest testing of tissue samples,

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soil, or water may be more appropriate Reporting Requirements description of the measures at certain times during the growing AMS received eight comments implemented in the previous year and season. regarding reporting requirements. any measures to be implemented in the AMS agrees with the commenters’ Several commenters requested coming years to meet the requirements suggestions and has amended the clarification on the use of the term in this rule for periodic residue testing. regulatory text accordingly to clarify ‘‘promptly’’ in reporting results to the In addition, AMS notes that certifying that testing may be conducted AMS Administrator (Administrator). agents should continue to maintain the preharvest or postharvest, and that The proposed rule did not specify a complete results of laboratory analyses residue testing is not limited to salable reporting time period and retained the for residues of pesticides and other products only. The final rule specifies term ‘‘promptly’’ from the existing NOP prohibited substances conducted during the types of materials for sampling that requirements at section 205.670. the current and three preceding are currently listed in section Several commenters also requested a calendar years, as required by section 205.403(c)(3) for on-site inspections. distinction between reporting violative 205.504(b)(5)(iii). This may include collection and testing versus non-violative sample results. The The final rule also clarifies the of soil; water; waste; seeds; plant tissue; commenters suggested that violative reporting requirements when test results and plant, animal, and processed samples (i.e., samples with residues indicate that a specific agricultural products samples. AMS notes that, in detected) could be reported to the product contains pesticide residues or the case of pesticide residue testing, Administrator as the information was environmental contaminates that exceed tolerances are established by the the Food and Drug Administration’s Environmental Protection Agency (EPA) received, but requested that non- violative samples (i.e., where no (FDA) or EPA’s regulatory tolerances. for specific harvested commodities. Under section 6506 of the OFPA, These tolerances enable the certifying residues are detected) be reported on a more infrequent basis, such as quarterly certifying agents, to the extent that they agent to take appropriate enforcement are aware of a violation of applicable action, if warranted, for the harvested or annually. One commenter requested that reporting be required on at least an laws relating to food safety, are required commodity. If a prohibited residue is to report such violation to the detected in a sample where there is not annual basis, but not more than twice annually. Two commenters requested appropriate health agencies. This is an established tolerance, such as soil, promulgated in section 205.670(e), water, or other plant tissues, follow-up that the NOP require all results to be reported and incorporated into a dataset amended by this final rule at 205.670(g), testing of the harvestable product may of the NOP regulations, which requires be needed for the certifying agent to that would be available to the public. After further consideration, AMS has reporting to the Federal health agency determine the appropriate enforcement whose regulatory tolerance or action action. amended the reporting requirements required under section 205.670 in order level has been exceeded. The NOP Additionally, AMS notes that issued a policy memo on reporting certifying agents currently have the to reduce the reporting burden on certifying agents. This rule eliminates health and safety violations to authority to collect samples under 4 the requirement that certifying agents stakeholders and interested parties. section 205.403(c) which states that This final rule clarifies the reporting ‘‘The on-site inspection of an operation must submit all residue testing results to the Administrator or State organic requirements at 205.670(g), but does not must verify: (3) That prohibited change the responsibility for reporting substances have not been and are not program’s governing State official. AMS does not intend to consolidate residue by certifying agents when residues are being applied to the operation through found in excess of federal regulatory means which, at the discretion of the testing data from certifying agents and tolerances established by EPA or FDA. certifying agent, may include the does not need reporting of residue The final rule indicates that certain collection and testing of soil; water; testing results as the mechanism to residue testing results that are in waste; seeds; plant tissue; and plant, ensure that certifying agents are meeting violation of EPA or FDA requirements animal, and processed products the requirement periodic residue must be reported to the appropriate samples.’’ testing. AMS intends to verify compliance of State health agency or foreign Types of Samples—Changes Requested certifying agents with the requirements equivalent. This change in the But Not Made for periodic residue testing as part of the regulations is intended to recognize the AMS received one comment existing accreditation process. role of State agencies, or their foreign requesting that processed products Accreditation requirements at section equivalents, in responding to residues which are to be sold or labeled as 205.504(b)(6) require certifying agents to in violation of tolerance requirements. ‘‘organic’’ or ‘‘made with organic have administrative policies and One comment from a certifying agent (specified ingredients or food group(s))’’ procedures, including procedures to be that operates outside of the United be excluded from residue testing used for sampling and residue testing States indicated that reporting test requirements. The commenter states pursuant to § 205.670. Certifying agents results that exceed federal regulatory that testing would not pinpoint the are also required to submit an annual tolerances is under the operator’s source of contaminants in processed, report to the Administrator on or before responsibility. The commenter multi-ingredient products. In certain the anniversary date of the issuance of indicated that, as a certifying agent, it cases, the source of a residue detected notification of accreditation which would check to make sure reporting was in a multi-ingredient processed product includes a complete and accurate done correctly by the operation, and may be more difficult to identify; update of information submitted that the certifying agent would inform however, we have retained the pursuant to §§ 205.503 and 205.504. In the NOP. AMS disagrees. Under the allowance for testing processed order to verify that certifying agents are OFPA (7 U.S.C. 6506), certifying agents, products to allow certifying agents the implementing this rule in advance of to the extent that they are aware of a flexibility of sampling processed regularly scheduled on-site audits, AMS 4 NOP Policy Memo 11–6, Reporting Health & products when it may be useful to intends to require, as authorized under Safety Violations, revised October 31, 2011. determine compliance with the section 205.510(a)(3), certifying agents Available at http://www.ams.usda.gov/AMSv1.0/ regulations. to submit in their next annual report a getfile?dDocName=STELPRDC5088951.

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violation of applicable laws relating to mislabeling (e.g., to deter substitution of adopt this same approach and indicated food safety, are required to report such conventionally produced herbs for that it encourages certifying agents to violation to the appropriate health organic wild-crop harvested herbs). take the amount of samples which is agencies. This requirement is The commenter also requested written necessary, and not just what is required promulgated at section 205.670 of the clarification as to how unavoidable by the regulations. Another commenter regulations. This final rule clarifies the pesticide residue contamination of wild expressed support for this model. reporting requirements, but does not crops would be addressed under the Section 205.670(b) currently provides change the responsibility for reporting regulation in the absence of EPA- that preharvest and postharvest testing by certifying agents. established tolerances for most plant is conducted at a certifying agent’s In addition to the reporting species. A clarification is included in expense. Similar to that provision, it is requirements outlined in the final rule, the draft guidance NOP 5028— reasonable that periodic residue testing the NOP published, on June 13, 2011 in Responding to Results from Pesticide also be conducted at the certifying the Federal Register (76 FR 34180), the Residue Testing, as described below agent’s expense, and therefore no availability of draft guidance entitled, under Related Documents. changes are made to the final rule based NOP 5028—Responding to Results from International Trade on these comments. Pesticide Residue Testing, that outlines Several commenters requested a more the actions to be taken by accredited AMS received one comment from an thorough analysis of the costs of certifying agents if test results from organic industry group in Canada which implementing periodic residue testing. residue analysis show evidence of opposed the proposed rule. The A more detailed analysis of the costs prohibited substance(s) in or on the commenter stated that the United States associated with this action is provided product. The notice included a 60-day and Canada are currently signatories to under the section titled Executive Order comment period, which closed on an equivalency determination for 12866 and Executive Order 13563. AMS August 12, 2011. After review of the organic products, and that the notes that a minority of certifying agents comments received, the NOP intends to imposition of a costly measure on the currently conduct periodic residue publish final guidance on this issue in United States’ side, without a testing at or above the minimum levels the NOP Handbook, as described under corresponding rule in Canada, could established by this final rule and there Related Documents. Under section lead the identification of this regulatory would be no additional costs associated 205.671, when residue testing detects change as a critical variance which with this action for those certifying prohibited substances that are greater would impede trade. Residue testing is agents. The majority of certifying agents, than five percent of the EPA’s tolerance required under the European Union’s however, would need to allocate for the specific residue detected or (EU) organic standards and, in 2011, additional resources for the costs unavoidable residual environmental Canada and the EU signed an organic associated with periodic residue testing. contamination, the agricultural product equivalency determination that does not AMS received one comment from a must not be sold, labeled, or represented include any critical variances related to certifying agent operating outside of the as organically produced. This final rule residue testing. In addition, certifying United States which indicates that it does not change this existing agents accredited under the NOP must currently tests 20–25% of its certified requirement. The draft guidance already conduct sampling and operations, which is above the document provides information to laboratory testing in instances where minimum level specified in this final certifying agents on how to respond to contamination is suspected under rule. results that indicate residues of sections 205.403(c)(3) and 205.670(b). One comment from a laboratory prohibited substances and how to report AMS does not anticipate that this indicated that AMS’ estimated $500 cost results that are in violation of FDA or requirement for periodic residue testing for analysis was high by a factor of two EPA’s regulatory tolerances as required will impact the United States’ or more, and that it may be able to by section 205.670(g). equivalency determination with Canada. perform this analysis for certifying agents at $250 per sample or less. The Wild Crops—Changes Requested But Costs and Cost Estimates—Changes commenter’s estimate appears to be Not Made Requested But Not Made limited to the direct laboratory costs of AMS received one comment from a AMS received eighteen comments residue analysis, and does not include certified operation regarding the testing regarding estimates of the costs of the additional related costs that AMS of wild crops. The commenter requested testing. In the proposed rule, AMS had has included in the estimated costs per an exemption from the requirement for estimated the cost at $500 per sample, sample. periodic residue testing for wild crops and estimated that the costs may Several commenters indicated that the on the basis that EPA tolerances are not represent approximately 1% of a costs may disproportionally affect established for most herbs in commerce. certifying agent’s operating budget. smaller certifying agents, since they The commenter suggests that the Several commenters stated their belief would not be able to receive quantity absence of established tolerances places that residue testing at the certifying discounts. Some laboratories may offer wild crops at disproportionate risk of agent’s own expense was a disincentive discounts to its higher-volume clients, enforcement actions as a result of the to residue testing, and that the OFPA including certifying agents. However, detection of trace amounts of did not directly address who must pay AMS also notes that lowering the unavoidable contamination (e.g., drift) for testing. A comment from a certifying percentage below five percent does not of unknown origin. AMS disagrees. One agent who certifies operations to the have an impact on the smallest quartile of the purposes of periodic residue organic standards of the EU, the of certifying agents that certify fewer testing is to provide a means for Japanese Agricultural Standard (JAS), than thirty operations per year, since monitoring compliance with the NOP by and the NOP, indicated that the they are required to sample a minimum discouraging the mislabeling of regulations of the EU and JAS do not of one operation annually. agricultural products. AMS has oblige the certifying agent to pay for One commenter suggested an determined that all crops should be pesticide analyses; instead, the cost is alternative funding mechanism, such as included within the scope of periodic directly passed on to the operator. The having pesticide manufacturers and residue testing to serve as a deterrent for commenter suggested that the NOP producers of genetically modified seed

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pay for the costs of testing. AMS does testing of organically produced applicable validated methodology for not have the statutory authority to agricultural products. This document is determining the presence of institute this type of third-party funding available at the NOP Web site at contaminants in agricultural products. model. http://www.ams.usda.gov/nop and is On February 2, 2011, the NOP provided discussed below under Related instructions on laboratory selection Purpose of Testing—Changes Requested Documents. AMS has not included a criteria for pesticide residue testing to But Not Made specific list of pesticide residues that certifying agents. These instructions are AMS received several comments could be tested for in the regulations. further described below under Related requesting clarification on the purpose This is intended to allow flexibility in Documents and are available on the of residue testing. revising the list of target pesticide NOP Web site at http://www.ams.usda. AMS is publishing this final rule to residues as new pesticides enter the gov/nop. AMS anticipates that these implement the requirements of the market. In addition, this flexibility instructions will change over time in OFPA for periodic residue testing by allows the NOP to respond more quickly response to advances in testing certifying agents. Residue testing plays to observed trends in detection of methodology, analytical an important role in organic residues on specific commodities. instrumentation, and residue detection certification by providing a means for The NOP does not intend for techniques. monitoring compliance with the NOP certifying agents to test every sample for AMS received several comments regulations and by discouraging the all residues on the list of target regarding ISO 17025 accreditation of mislabeling of agricultural products. pesticides. Instead, the list is provided laboratories. This accreditation is AMS does not intend to integrate as a reference for a number of pesticides mentioned in NOP 2611, Laboratory results into a single dataset, as was which are prohibited under the NOP Selection Criteria for Pesticide Residue requested by some commenters. To regulations, and that may be detected by Testing, which is further discussed minimize the reporting burden for a laboratory that conducts multi-residue under Related Documents and is certifying agents, this final rule does not analysis of agricultural products. available on the NOP Web site at require that certifying agents submit AMS received one comment that http://www.ams.usda.gov/nop. No copies of test results to the indicated that this list would serve as a comments requested the incorporation Administrator; however, certifying ‘‘cheat sheet’’ for operations seeking to of ISO 17025 accreditation into the agents continue to be required to report willfully violate the NOP regulations. regulatory text. The comments are under certain test results that are found in AMS disagrees. The document provides consideration for future revision of the excess of federal regulatory tolerances or a list of pesticide residues most instruction documents and are not action levels for pesticide residues or commonly found on conventional impacted by this rulemaking action. environmental contaminants to the commodities, based on data obtained appropriate health agency under the from the AMS Pesticide Data Program. Information Collection Burden section 205.670(g). This final rule does This list is intended to instruct The proposed rule requested not require reporting of testing data to certifying agents and laboratories on comments on the information collection the Administrator since this action is which residues would be the most and recordkeeping requirements not intended as a data collection useful targets for multi-residue analysis required by the proposed amendments mechanism to draw conclusions about of agricultural products. The regulations to section 205.670. Comments were residues in organic products in general. and guidance documents do not specifically invited on (1) whether the AMS will verify compliance of prohibit a certifying agent from testing proposed collection of information is certifying agents with this rule under for other residues if the presence of a necessary for the proper performance of the existing requirements for specific pesticide is suspected. the functions of the agency, including accreditation as discussed in the Four commenters requested whether the information will have response to comments on Reporting clarification on testing for genetically practical utility; (2) the accuracy of the Requirements. modified organisms (GMOs). AMS does agency’s estimate of the burden of the The NOP also notes that this final rule not intend for the testing conducted proposed collection of information does not amend the existing under section 205.670 to be limited to including the validity of the requirement that results of all analyses pesticides residues. Under the existing methodology and assumptions used; (3) and tests performed under section provisions at section 205.670, certifying ways to enhance the quality, utility, and 205.670 be made available for public agents have the flexibility to test for a clarity of the information to be access, unless the testing is part of an range of prohibited materials and collected; and (4) ways to minimize the ongoing compliance investigation. The excluded methods, including, but not burden of the collection of information public may access sampling results limited to, pesticides, hormones, on those who are to respond, including obtained by certifying agents under the antibiotics, and GMOs. AMS notes that, the use of appropriate automated, existing regulations. under section 205.671, thresholds for electronic, mechanical, or other unavoidable residual environmental technological collection techniques or Types of Residues—Changes Requested contamination are established only for other forms of information technology. But Not Made pesticides residues. AMS received four comments AMS received four comments specifically on the issue of information regarding types of residues that would Testing Methodology collection burden. Two comments be considered acceptable targets for The final rule maintains the current indicated that they were unclear testing under the rule. requirement under section 205.670 that whether the estimated time is accurate On February 2, 2011, the NOP chemical analysis must be made in and that more data and analysis was published NOP 2611–1, Prohibited accordance with the methods described needed. One commenter suggested that Pesticides for NOP Residue Testing, on in the most current edition of the the NOSB should hear from the various the NOP Web site in the NOP Official Methods of Analysis of the stakeholders in public forums before Handbook. This document provides a AOAC International 5 or other current AMS considers the accuracy of the list of target pesticides to certifying estimate. One commenter indicated that agents that conduct pesticide residue 5 http://www.aoac.org/. the estimate of 1.74 hours appears to be

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low, especially when foreign operations programs. AMS notes that testing manage, or certify organic operations and imported products are considered, conducted by other third-parties does with guidance, instructions, and policy but did not offer an alternative estimate not eliminate the requirement under memos that can assist them in for the number of hours or data to OFPA for residue testing by certifying complying with the NOP regulations. support a different estimate. agents. AMS believes that requiring The most recent edition of the NOP Two comments indicated that certifying agents to conduct residue Handbook is available for viewing and submission of report copies, or testing from a minimum of five percent downloading through the NOP Web site laboratory summaries of test results, of the operations they certify is a at http://www.ams.usda.gov/nop. should be sufficient to demonstrate reasonable number which ensures that The three instruction documents are compliance with the requirement. In all certifying agents, regardless of the meant to inform certifying agents about order to reduce the information number of operations they certify, are best practices for conducting residue collection burden on certifying agents, responsible for some level of regular testing of organically produced AMS has removed the requirement that testing at reasonable cost. agricultural products. NOP 2610, test results be reported to the One comment indicated that Sampling Procedures for Residue Administrator. AMS has retained the certifying agents would prefer to submit Testing, contains recommended requirement that test results that test results on a quarterly basis. In this procedures for product sampling, indicate a specific agricultural product final rule, AMS has removed the including documentation, contains pesticide residues or requirement for reporting results of recommended sample sizes, shipping environmental contaminants that residue testing, with the exception of conditions to the laboratory, and chain exceed the Food and Drug results that exceed certain federal of custody requirements. NOP 2611, Administration’s or the Environmental regulatory requirements established by Laboratory Selection Criteria for Protection Agency’s regulatory EPA or FDA. AMS notes that certifying Pesticide Residue Testing, contains tolerances be reported to the appropriate agents should maintain the complete instructions for certifying agents in health agency. results of laboratory analyses for selecting a qualified laboratory for AMS intends to verify compliance of residues of pesticides and other pesticide residue testing, including certifying agents with the requirements prohibited substances conducted during accreditation, quality assurance, for periodic residue testing as part of the the current and three preceding proficiency testing, and reporting existing accreditation process, rather calendar years, as required by section guidelines. NOP 2611–1, Prohibited than by requiring submission of residue 205.504(b)(5)(iii). Pesticides for NOP Residue Testing, is a testing results. Accreditation list of pesticide residues that certifying Comments on Instruction Documents requirements at section 205.504(b)(6) agents can provide to laboratories which require certifying agents to have AMS received four comments on conduct pesticide residue testing of administrative policies and procedures, instruction documents that the NOP has agricultural products. The three including procedures to be used for published in the NOP Handbook instruction documents were effective sampling and residue testing pursuant regarding residue testing. The immediately upon their issuance and to § 205.670. Certifying agents are also instruction documents are discussed publication on February 2, 2011. required to submit an annual report to under Related Documents. These On June 13, 2011, the NOP published the Administrator on or before the comments are beyond the scope of this draft guidance, NOP 5028—Responding anniversary date of the issuance of rulemaking; however, they are under to Results from Pesticide Residue notification of accreditation which consideration for future revision of the Testing, that outlines the actions to be includes a complete and accurate instruction documents through a taken by accredited certifying agents if update of information submitted separate action. test results from residue analysis show pursuant to §§ 205.503 and 205.504. In III. Related Documents evidence of prohibited substance(s) in order to verify that certifying agents are or on the product. A notice on the implementing this rule in advance of A proposed rule was published in the availability of draft guidance was regularly scheduled on-site audit of Federal Register on April 29, 2011 (76 published in the Federal Register (76 certifying agents, AMS intends to FR 23914). Additional documents FR 34180) with a 60 day comment require, as authorized under section related to this final rule include the period. The comment period closed on 205.510(a)(3), certifying agents to Organic Foods Production Act (OFPA), August 12, 2011, and comments are submit in their next annual report a as amended (7 U.S.C. 6501–6522) and under review by the NOP. After review description of the measures its implementing regulations (7 CFR of the comments received, the NOP implemented in the previous year and part 205). The March 2010 USDA Office intends to publish the final guidance in any measures to be implemented in the of Inspector General audit report of the the NOP Handbook. coming years to meet the requirements National Organic Program is available as Members of the public who wish to 6 in this rule for periodic residue testing. Audit Report 01601–03–Hy. request that the agency issue, AMS received one comment that The NOP has also published three reconsider, modify, or rescind a indicated that the proposed rule did not instruction documents related to residue guidance or instruction document may identify what would be done with the testing as part of the NOP Handbook: (1) do so by sending an email to Sampling Procedures for Residue information collected. A response is [email protected] or by Testing (NOP 2610), (2) Laboratory provided above under the section, mailing a letter to Standards Division, Selection Criteria for Pesticide Residue Purpose of Testing—Changes Requested National Organic Program, U.S. Testing (NOP 2611), and (3) Prohibited But Not Made. Department of Agriculture, Room 2646- Pesticides for NOP Residue Testing One comment suggested that existing So. (Stop 0268), 1400 Independence (NOP 2611–1). The goal of the NOP testing programs, such as the AMS Ave. SW., Washington, DC 20250–0268. Pesticide Data Program, should be used Handbook is to provide those who own, to the extent possible. The commenter IV. Statutory and Regulatory Authority also suggested that AMS should partner 6 U.S. Department of Agriculture, Office of OFPA authorizes AMS to administer Inspector General, Audit Report 01601–03–Hy, with the FDA and various State agencies March 2010. Available at http://www.usda.gov/oig/ the NOP. Under the NOP, AMS oversees that currently conduct residue testing webdocs/01601-03-HY.pdf. national standards for the production

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and handling of organically produced requires that the NOP include annually; (3) requiring testing at an agricultural products. provisions for periodic residue testing alternate level of 25% of the operations Section 6506 of the OFPA requires by certifying agents of agricultural certified by a certifying agent; and (4) periodic residue testing by certifying products produced or handled in testing all certified operations annually. agents of agricultural products that have accordance with the NOP. This final In addition, proposals for testing at a been produced on certified organic rule ensures that all certifying agents reduced sampling rate, and testing farms and handled through certified conduct a minimal level of residue scaled to the size of operation or to the organic handling operations to testing. number of certified organic products determine whether such products Residue testing plays an important were suggested by commenters and are contain any pesticide or other role in organic certification by providing discussed under the above section, nonorganic residue or natural toxicants. a means for monitoring compliance with Number of Samples—Changes This section also requires certifying the NOP and by discouraging the Requested But Not Made. AMS believes agents to report violations of applicable mislabeling of agricultural products. that calculating the samples based on a laws relating to other federal tolerance Testing of organically produced percentage of operations reduces the requirements (e.g., pesticide residues in agricultural products is promulgated in burden on the certifying agents by excess of FDA action levels or EPA section 205.670 of the NOP regulations. providing a clear and simple formula for tolerances) to the appropriate health This section provides that the Secretary, how to comply with the regulations. agencies. Additional information on State organic programs, and certifying AMS has not specified how certifying reporting health and safety violations agents may require preharvest or agents must select operations for residue has been previously provided by the postharvest testing of any agricultural testing to provide flexibility and NOP to stakeholders and interested input used or agricultural product to be discretion to the certifying agent in how parties.7 This information is available sold, labeled, or represented as ‘‘100 to most efficiency and effectively on the NOP Web site at http://www.ams. percent organic,’’ ‘‘organic,’’ or ‘‘made implement the minimum testing usda.gov/nop. with organic (specified ingredients or required under the rule. Operation Section 6511 of the OFPA requires the food group(s))’’ when there is reason to selection for residue testing may include Secretary, the applicable governing believe that the agricultural input or risk factors such as number of products State official, and the certifying agent to product has come into contact with a produced, split operations, size of the utilize a system of residue testing to test prohibited substance or has been operation, split operations (i.e., products sold or labeled as organically produced using excluded methods. operations that produce or handle both produced. AMS is issuing this final rule in organic and nonorganic agricultural Section 6511 of the OFPA also allows response to an audit of the NOP which products), previous non-compliances, the Secretary, the applicable governing was conducted in March 2010 by the high-value or high-risk crops, or other State official, or the certifying agent to 8 USDA’s OIG. As part of the audit, the criteria deemed appropriate by the require preharvest tissue testing of any OIG visited four certifying agents certifying agent. crop grown on soil suspected of accredited by the NOP. The OIG The first alternative of maintaining harboring contaminants. indicated that these certifying agents the status quo was not considered A. Executive Order 12866 and Executive noted that they considered residue feasible due to a finding identified in an Order 13563 testing to be required by the regulations audit report issued by USDA’s OIG in only under certain circumstances. March 2010.9 In response to the OIG Executive Orders 13563 and 12866 AMS conducted a review of this issue audit, AMS conducted a review of the direct agencies to assess all costs and in response to the OIG audit. AMS residue testing requirements in OFPA benefits of available regulatory concluded that, under 7 U.S.C. section and the NOP regulations. AMS alternatives and, if regulation is 6506 of the OFPA, accredited certifying concluded that, under section 6506 of necessary, to select regulatory agents are required to conduct residue the OFPA, accredited certifying agents approaches that maximize net benefits testing of organic products on a regular (including potential economic, and reoccurring basis, as well as when are required to conduct residue testing environmental, public health and safety there is reason to believe contamination of organic products on a regular and effects, distributive impacts, and has occurred. reoccurring basis, as well as when there equity). Executive Order 13563 is reason to believe contamination has emphasizes the importance of Regulatory Objective occurred, and that the regulations be quantifying both costs and benefits, of The primary objective of this rule is revised as provided for in this reducing costs, of harmonizing rules, to align the NOP regulations with the rulemaking. and of promoting flexibility. This action requirement for residue testing of The second alternative distinguishes has been determined not significant for organic products under OFPA. This between periodic residue testing and purposes of Executive Order 12866, and final rule ensures that all certifying risk-based testing for purposes of therefore, has not been reviewed by the agents conduct a minimum level of calculating the percentage of operations Office of Management and Budget. residue testing. to be tested annually. This alternative was discussed in the proposed rule Need for the Rule Alternatives Considered published April 29, 2011 (76 FR 23914). NOP is authorized to implement Alternatives to this final rule that The proposed rule indicated that regulations that require accredited were considered include (1) maintaining certifying agents would need to sample certifying agents to conduct residue the status quo; (2) distinguishing a minimum of five percent of their testing of organically produced periodic residue testing from risk-based certified operations annually, and that agricultural products (7 U.S.C. 6511). In testing for purposes of calculating the such testing would be in addition to any addition, section 6506 of the OFPA percentage of operations to be tested testing conducted when there was

7 NOP Policy Memo 11–6, Reporting Health & 8 U.S. Department of Agriculture, Office of 9 U.S. Department of Agriculture, Office of Safety Violations, revised October 31, 2011. Inspector General, Audit Report 01601–03-Hy, Inspector General, Audit Report 01601–03-Hy, Available at http://www.ams.usda.gov/AMSv1.0/ March 2010. Available at http://www.usda.gov/oig/ March 2010. Available at http://www.usda.gov/oig/ getfile?dDocName=STELPRDC5088951. webdocs/01601-03-HY.pdf. webdocs/01601-03-HY.pdf.

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reason to believe that the agricultural understands that there may be by most accredited certifying agents. product had come into contact with a additional certifying agents that are Direct costs to the certifying agents prohibited substance (e.g., investigative currently conducting residue testing include the cost of sample analysis (i.e., or complaint-driven testing). This that do not report results to the NOP, or laboratory costs), sample packaging and alternative would result in higher costs that submit results only when a shipping costs, and the staff costs to the certifying agent, since costs prohibited residue is detected. associated with sample collection by an associated with other types of testing The number of results reported to the inspector, review and maintenance of would be in addition to costs for NOP in 2011 represents a sampling rate sample results, and reporting costs. In periodic testing. After consideration of of less than 1% of certified operations. addition, some certifying agents the comments received, AMS believes The majority of results reported to the indicated that the proposed action that the final rule offers more flexibility NOP in 2011 were received from would also increase their training costs by allowing both complaint-driven and certifying agents which are for review staff and field inspectors. periodic residue testing to count toward headquartered outside of the United AMS is unable to ascertain how the sample minimum. This final rule States, where periodic residue testing is certification fees may shift in response should also minimize the burden on a requirement under international to this action because of the diversity of certifying agents by removing the need organic standards (e.g., the EU). AMS fee structures used by certifying agents. to distinguish between different types of received one comment on the proposed The total direct cost of this action is testing. rule from a certifying agent operating estimated to be $741,000 annually. This The third alternative of requiring outside of the United States which estimate is based on a sampling rate of certifying agents to test 25% of the indicates that it currently tests 20–25% five percent of certified operations. operations they certify annually was of its certified operations. There were an estimated 30,118 also considered. This target is based a AMS received one comment from a operations certified under the NOP in statistically based sample size based certifying agent that indicated that it has 2011. The five percent sampling upon the rate of detection of residues in a history of sampling and testing requirement would result in sample organic products sampled through the products for more than 20 years. This collection from approximately 1,506 AMS Pesticide Data Program (PDP). The commenter supported the five percent operations per year. AMS has estimated costs associated with this alternative testing requirement as outlined in the the total costs to the certifying agent at and that would be imposed on certifying proposed rule and did not support $492 per sample as detailed in Table 1. agents are estimated at $3.70 million revising the rule to include compliance Sample collection costs (inspector annually, based on an estimated $492 in or investigative testing as part of the five costs) are estimated at $20.36 per costs to the certifying agent per percent. AMS also received one sample. This estimate is based on an operation tested across 7,530 certified comment from a certifying agent that estimated 1.0 labor hour per sample at operations (25% of 30,118). The costs had increased their testing program for $20.36 per hour. The hourly rate is associated with testing 25% of residues within the last two years and estimated based on the mean hourly operations are significantly higher than requested that the proposed rule be wage for agricultural inspectors as the costs of sampling 5% of operations revised to allow sampling from sources published by the Bureau of Labor under the final rule. AMS determined other than the agricultural product (e.g. Statistics.10 This classification was that using a statistically based sample samples of soil, water, seeds) to be selected as an occupation with similar size is not necessary to achieve the counted towards the minimum testing duties and responsibilities to that of an regulatory objective of this action and requirement. Under this final rule, organic inspector. Such duties and would impose unnecessary additional sampling from a range of sources as responsibilities include inspection of direct costs to certifying agents. indicated in sections 205.670(b) and (c) The fourth alternative of sampling all agricultural commodities, processing may be counted towards the minimum equipment, and facilities, to ensure operations annually was also considered testing requirement. as an alternative to the five percent compliance with regulations and laws minimum requirement. The costs Benefits to the Final Rule governing health, quality, and safety. associated with this alternative are This final rule clarifies a provision of Sample shipping boxes and supplies estimated at $14.82 million annually, OFPA and the regulations issued are estimated at $40 per sample, based based on an estimated $492 in costs per thereunder that requires periodic on a costs associated with a pilot project operation for 30,118 certified residue testing of organically produced for pesticide residue sampling operations. The objectives for periodic agricultural products by accredited conducted by the NOP in conjunction residue testing can be met by sampling certifying agents. The rule ensures with the AMS Pesticide Data Program. a subset of operations annually, and consistency of the regulations with Shipping costs are estimated at $25 per therefore, the additional costs that OFPA by ensuring that all certifying sample. AMS notes that these costs are would be required to test all operations agents are conducting residue testing of an average and may vary depending on are unnecessary. organic products on a regular the sample type and shipping distance reoccurring basis. Residue testing plays to laboratory. Baseline an important role in organic Labor costs associated with review of AMS is aware that a minority of certification by providing a means for sample results are estimated at $16.21 accredited certifying agents are monitoring compliance with the NOP per sample. This estimate is based on an currently conducting periodic residue and by discouraging the mislabeling of estimated 0.5 labor hour per sample at testing at or above the minimum levels agricultural products. This action $32.42 per hour. The hourly rate is established by this final rule. In 2011, further ensures the integrity of products estimated based on the mean hourly the NOP received pesticide residue produced and handled under the NOP wage for auditors as published by the results from 13 accredited certifying regulations. agents. Seven of the certifying agents 10 Mean Hourly Wage for Agricultural Inspector, Costs of the Final Rule U.S. Department of Labor, Bureau of Labor that reported results to the NOP were Statistics, Occupational Employment and Wages, based in the United States and six were This final rule increases the amount May 2010. http://bls.gov/oes/current/ based internationally. The NOP also of residue testing currently conducted oes452011.htm.

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Bureau of Labor Statistics.11 This clarified in this final rule under In consideration of training costs, the classification was selected as an § 205.670(g); however, this is not a new NOP notes that, while this action occupation with similar duties and requirement under this action and expands the amount of testing of responsibilities to that of a certifying additional costs not expected from this organically produced agricultural agent. Such duties and responsibilities clarification. AMS expects that the products to include a requirement that include conducting reviews of majority of tested organic products will is regular and periodic in scope, operations against accepted standards not have detectable residues of certifying agents are already required, and evaluating audit or inspection prohibited pesticide substances, based under section 205.504(b)(6), to have findings for compliance. on historical data from the AMS procedures in place for sampling and If certifying agents receive sample Pesticide Data Program. residue testing pursuant to section results which are in excess of EPA or FDA regulatory tolerances, the certifying AMS believes that this rate of testing 205.670. Certifying agents must already agent must promptly report such data to provides the benefits at reasonable cost be conducting sampling and laboratory the Federal health agency (i.e., EPA or to certifying agents. AMS recognizes testing in instances where FDA) whose regulatory tolerance or that a minority of certifying agents contamination is suspected under action level has been exceeded. Test conduct residue testing on a regular section 205.403(c)(3) and section results that exceed federal regulatory basis, and that certifying agents not 205.670(b). Therefore, AMS does not tolerances must also be reported to the currently conducting testing will need believe that additional training costs are appropriate State health agency or to account for these costs as a cost of imposed by this final rule. foreign equivalent. This requirement is doing business.

TABLE 1—ESTIMATED COSTS PER SAMPLE COLLECTED

Estimated cost Item per sample Basis for estimate

Sample collection (inspector time) ...... $20.36 1 hour @ $20.36 per hour. Sample shipping boxes and supplies ...... 40.00 AMS Pesticide Data Program. Shipping costs ...... 25.00 Estimate for in-state shipping of 5 pound sample. Laboratory costs for multi-residue anal- 390.00 AMS Pesticide Data Program. ysis. Review of Sample Results—Labor Costs 16.21 0.5 hour @ $32.42 per hour.

Total costs per sample ...... 491.57

B. Executive Order 12988 and for the certification of organic farm appeal an action of the Secretary, the Executive Order 12988 instructs each and handling operations located within applicable governing State official, or a executive agency to adhere to certain the State under certain circumstances. certifying agent under this title that requirements in the development of new Such additional requirements must: (a) adversely affects such person or is and revised regulations in order to avoid Further the purposes of the OFPA, (b) inconsistent with the organic unduly burdening the court system. not be inconsistent with the OFPA, (c) certification program established under This final rule is not intended to have not be discriminatory toward this title. The OFPA also provides that a retroactive effect. agricultural commodities organically the U.S. district court for the district in States and local jurisdictions are produced in other States, and (d) not be which a person is located has preempted under the OFPA from effective until approved by the jurisdiction to review the Secretary’s creating programs of accreditation for Secretary. decision. Pursuant to section 6519 of the OFPA, private persons or State officials who C. Executive Order 13175 want to become certifying agents of this final rule would not alter the organic farms or handling operations. A authority of the Secretary under the This final rule has been reviewed in governing State official would have to Federal Meat Inspection Act (21 U.S.C. accordance with the requirements of apply to USDA to be accredited as a 601–624), the Poultry Products Executive Order 13175, Consultation certifying agent, as described in section Inspection Act (21 U.S.C. 451–471), or and Coordination with Indian Tribal 6514(b) of the OFPA. States are also the Egg Products Inspection Act (21 Governments. The review reveals that preempted under sections 6503 through U.S.C. 1031–1056), concerning meat, this regulation will not have substantial 6507 of the OFPA from creating poultry, and egg products, nor any of and direct effects on Tribal governments certification programs to certify organic the authorities of the Secretary of Health and will not have significant Tribal farms or handling operations unless the and Human Services under the Federal implications. Food, Drug and Cosmetic Act (21 U.S.C. State programs have been submitted to, D. Regulatory Flexibility Act and approved by, the Secretary as 301–392), nor the authority of the meeting the requirements of the OFPA. Administrator of the EPA under the The Regulatory Flexibility Act (RFA) Pursuant to section 6507 of the OFPA, Federal Insecticide, Fungicide and (5 U.S.C. 601–612) requires agencies to a State organic certification program Rodenticide Act (7 U.S.C. 136–136(y)). consider the economic impact of each may contain additional requirements for Section 6520 of the OFPA provides rule on small entities and evaluate the production and handling of for the Secretary to establish an alternatives that would accomplish the organically produced agricultural expedited administrative appeals objectives of the rule without unduly products that are produced in the State procedure under which persons may burdening small entities or erecting

11 U.S. Department of Labor, Bureau of Labor May 2009. http://www.bls.gov/oes/2009/may/ Statistics, Occupational Employment and Wages, oes132011.htm.

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barriers that would restrict their ability minimum of five percent of the being conducted by some certifying to compete in the market. The purpose operations they certify on an annual agents. As a percentage of a certifying of the RFA is to fit regulatory actions to basis. This level was chosen to ensure agent’s total operating costs, this the scale of businesses subject to such that all certifying agents, regardless of estimate was revised upward from one actions in order that small business will the number of operations they certify, percent to two percent, based on public not be unduly or disproportionately are responsible for some level of regular comment received in response to the burdened. Section 605 of RFA allows an residue testing at reasonable cost. Under proposed rule. Comments included a agency to certify a rule, in lieu of section 205.670, certifying agents have summary of data from an association preparing an analysis, if the rulemaking been responsible for expenses representing certifying agents, and is not expected to have a significant associated with preharvest and included data from 25 certifying agents. economic impact on a substantial postharvest testing; this requirement The range of costs was reported at number of small entities. also applies to expenses for periodic between 1% and 11% of a certifying Pursuant to the requirements set force residue testing in this final rule. To agent’s overall operating budget, with in the RFA, AMS performed an estimate the annual costs associated one certifying agent reporting that the economic impact analysis on small with instituting periodic residue testing, cost of one sample would account for entities in the final rule published in the the NOP conducted a preliminary 11% of their total operating costs for the Federal Register on December 21, 2000 assessment of costs at different year and one certifying agent reporting (65 FR 80548). AMS has also considered minimum testing requirements (i.e., 5%, that the cost for three samples would the economic impact of this final rule 25%, and 100% of certified operations). account for 1% of their total operating on small entities. AMS certifies that this Under this new action with a five costs. The majority of these certifying rule would not have a significant percent minimum testing requirement, agents estimated the costs associated economic impact on a substantial the two certifying agents with the largest with this action to account for no more number of small entities. number of certified operations than 2% of their operating budget Small agricultural service firms, (approximately 2,100 operations each in annually. which include producers, handlers, and 2009) are required to collect a minimum Alternatives to this final rule that accredited certifying agents, have been of 105 samples. Smaller certifying were considered include (1) maintaining defined by the Small Business agents (those certifying fewer than 30 the status quo; (2) distinguishing Administration (SBA) (13 CFR 121.201) operations) are required to collect and periodic residue testing from risk-based as those having annual receipts of less test at least 1 sample on an annual basis. testing for purposes of calculating the than $7,000,000 and small agricultural In 2010, approximately one-third of percentage of operations to be tested producers are defined as those having accredited certifying agents certified annually; (3) requiring testing at an annual receipts of less than $750,000. fewer than 30 operations to the NOP.14 alternate level of 25% of the operations According to Economic Research Over half of all certifying agents certified by a certifying agent; and (4) Service (ERS) data, based on certified fewer than 200 operations in testing all certified operations annually. information from USDA accredited 2010 and are required to sample 10 or These are discussed in detail above certifying agents, the number of certified fewer operations annually under this under Alternatives Considered. AMS U.S. organic crop and livestock final rule. determined that the alternatives of a operations totaled nearly 13,000 and At a five percent minimum testing statistically based sample size (i.e., 25% certified organic acreage exceeded 4.8 requirement, the costs of sampling are of operations annually) or testing all million acres in 2008.12 ERS, based estimated from approximately $492 to operations annually were not practical upon the list of certified operations 51,106 per certifying agent per year due to the costs and the uneven burden maintained by the NOP, estimated the based on the average cost of $492 per that could be placed upon smaller number of certified handling operations sample and the range in the number of certifying agents in either scenario. was 3,225 in 2007.13 AMS estimates that operations certified by different The U.S. sales of organic food and there were 30,118 operations certified to certifying agents. Additional costs may beverages have grown from $3.6 billion the NOP in 2011. USDA has 93 be required to follow up on results if in 1997 to nearly $21.1 billion in 15 accredited certifying agents that provide prohibited substances are detected. 2008. Between 1990 and 2008, organic certification services to producers and AMS expects that the majority of results food sales have historically handlers under the NOP. A complete will be for samples with no prohibited demonstrated a growth rate between 15 list of names and addresses of certifying residues detected, based on historical to 24 percent each year. In 2010, organic 16 agents may be found on the AMS NOP data from the AMS Pesticide Data food sales grew 7.7%. Web site at: http://www.ams.usda.gov/ Program. The NOP is authorized under OFPA nop. AMS believes that most of these AMS is establishing a five percent to implement regulations that require entities would be considered small testing level in this final rule because accredited certifying agents to conduct entities under the criteria established by this level is expected to be, in most residue testing of organically produced the SBA. cases, no more than two percent of a agricultural products (7 U.S.C. § 6511). This final rule will affect all certifying given certifying agent’s operating In addition, the OFPA requires that the agents by requiring that each agent budget, a level that can be considered a NOP include provisions for periodic conduct residue testing from a reasonable cost to the organic industry residue testing by certifying agents of given the benefits of residue testing in agricultural products produced or 12 U.S. Department of Agriculture, Economic discouraging the mislabeling of handled in accordance with the NOP (7 Research Service. 2009. Data Sets: U.S. Certified agricultural products. Furthermore, the Organic Farmland Acreage, Livestock Numbers and number of samples required at a five 15 Dimitri, C.; Oberholtzer, L. 2009. Marketing Farm Operations, 1992–2008. http:// percent level is consistent with the U.S. Organic Foods: Recent Trends from Farms to www.ers.usda.gov/Data/Organic/. Consumers, Economic Information Bulletin No. 58, 13 U.S. Department of Agriculture, Economic amount of residue sampling already U.S. Department of Agriculture, Economic Research Research Service, 2009. Data Sets: Procurement and Service, http://www.ers.usda.gov/Publications/ Contracting by Organic Handlers: Documentation. 14 As reported by certifying agents during the EIB58. http://www.ers.usda.gov/Data/OrganicHandlers/ 2010 certification year and available at http:// 16 Organic Trade Association’s 2011 Organic Documentation.htm. apps.ams.usda.gov/nop/. Industry Survey, http://www.ota.com.

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U.S.C. § 6506). This final rule ensures sample. At an estimated cost of $492 per E. Paperwork Reduction Act that all certifying agents conduct a sample and a sampling rate of 5% of In accordance with Office of minimal level of residue testing. certified operations, certifying agents Management and Budget (OMB) Residue testing plays an important would need to budget an estimated $25 regulations (5 CFR part 1320) that role in organic certification by providing per certified operation for testing costs. implement the Paperwork Reduction a means for monitoring compliance with The total costs of residue testing are Act (44 U.S.C. 3501–3520) (PRA), the the NOP and by discouraging the estimated at approximately $492 to information collection requirements mislabeling of agricultural products. $51,106 per certifying agent per year associated with the NOP have been Testing of organically produced based on the average cost of $492 per previously approved by OMB and agricultural products is promulgated in sample and the range in the number of assigned OMB control number 0581– section 205.670 of the NOP regulations. operations certified by different 0191. A new information collection This section provides that the Secretary, certifying agents. Additional costs may package was submitted to OMB at the State organic programs, and certifying be required to follow up on results if agents may require preharvest or proposed rule stage for approval of 776 prohibited substances are detected. The hours in total burden hours to cover this postharvest testing of any agricultural portion of the total estimated costs input used or agricultural product to be new collection and recordkeeping would be considered new or additional burden of the amendments to section sold, labeled, or represented as ‘‘100 costs as a result of this action is not percent organic,’’ ‘‘organic,’’ or ‘‘made 205.670 of this final rule. Between the known, as a minority of certifying proposed rule and this final rule, there with organic (specified ingredients or agents are already conducting residue food group(s))’’ when there is reason to is a reduction of 350 hours based on testing of organic products and have comments received. Upon OMB’s believe that the agricultural input or budgeted for these costs under their product has come into contact with a approval of this new information existing fee structures. If these costs collection, the NOP intends to merge prohibited substance or has been have not been previously budgeted for produced using excluded methods. this collection into currently approved by the certifying agent, it will need to OMB Control Number 0581–0191. However, AMS has concluded that, account for these costs as part of their under 7 U.S.C. § 6506 of the OFPA, AMS is committed to complying with cost of business. the E-Government Act to promote the accredited certifying agents are required To reduce additional inspector costs to conduct residue testing of organic use of the Internet and other associated with sample collection, AMS products on a regular and reoccurring information technologies to provide has not specified which operations must basis, as well as when there is reason to increased opportunities for citizen be sampled annually or when the believe contamination has occurred. access to Government information and The final rule is necessary to clarify samples must be collected. This is services, and for other purposes. intended to provide flexibility to the a requirement of OFPA that certifying F. Civil Rights Impact Analysis agents conduct periodic residue testing certifying agent implement a schedule of organic products. The final rule will for sample collection in the most AMS has reviewed this rule in increase the amount of residue testing efficient manner. accordance with the Department that certifying agents must conduct The final rule will increase costs for Regulation 4300–4, Civil Rights Impact when compared to the current certifying agents who are not currently Analysis (CRIA), to address any major regulations. This final rule ensures that performing residue testing at the civil rights impacts the rule might have certifying agents are conducting a minimal levels specified in this rule. on minorities, women, and persons with minimal level of residue testing on a Some certifying agents may increase disabilities. After a careful review of the regular and reoccurring basis. their certification fees for its clients to rule’s intent and provisions, AMS has The cost of testing is to be borne by pay for additional costs associated with determined that this rule has no the applicable certifying agent and is residue testing. At an estimated cost of potential for affecting certified considered a cost of doing business. $492 per sample and a sampling rate of operations or certifying agents in The population that is directly 5% of certified operations, certifying protected groups differently than the impacted by this final rule is accredited agents would need to budget general population of certified certifying agents. The USDA has 93 approximately $25 per operation for operations and certifying agents. This certifying agents who provide testing costs. rulemaking was initiated to clarify a certification services to producers and This final rule clarifies a provision of regulatory requirement and enable handlers under the NOP. A complete OFPA and the regulations issued consistent implementation and list of names and addresses of certifying thereunder that requires periodic enforcement. agents may be found on the AMS NOP residue testing of organically produced Protected individuals have the same Web site at: http://www.ams.usda.gov/ agricultural products by accredited opportunity to participate in the NOP as nop. AMS believes that most accredited certifying agents. The final rule expands non-protected individuals. The NOP certifying agents would be considered the amount of residue testing of regulations prohibit discrimination by small entities under the criteria organically produced agricultural certifying agents. Specifically, section established by the SBA. Approximately products by clarifying that sampling and 205.501(d) of the current regulations for 30,118 operations worldwide were testing are required on a regular basis. accreditation of certifying agents certified to the NOP standard in 2011; The final rule requires that certifying provides that ‘‘No private or certified operations may be indirectly agents, on an annual basis, sample and governmental entity accredited as a impacted by this action as additional conduct residue testing from a certifying agent under this subpart shall operations will be subject to residue minimum of five percent of the exclude from participation in or deny testing by certifying agents. operations that they certify. the benefits of the NOP to any person For certifying agents who are not AMS believes that the benefits of due to discrimination because of race, currently conducting residue testing at residue testing in protecting organic color, national origin, gender, religion, the minimum levels specified in the integrity and ensuring compliance with age, disability, political beliefs, sexual final rule, this action will increase costs. the regulations outweigh the estimated orientation, or marital or family status.’’ AMS has estimated costs at $492 per costs. Section 205.501(a)(2) requires

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‘‘certifying agents to demonstrate the require preharvest or postharvest testing residues or environmental contaminants ability to fully comply with the of any agricultural input used or that exceed the Food and Drug requirements for accreditation set forth agricultural product to be sold, labeled, Administration’s or the Environmental in this subpart’’ including the or represented as ‘‘100 percent organic,’’ Protection Agency’s regulatory prohibition on discrimination. The ‘‘organic,’’ or ‘‘made with organic tolerances, the certifying agent must granting of accreditation to certifying (specified ingredients or food group(s))’’ promptly report such data to the Federal agents under section 205.506 requires when there is reason to believe that the health agency whose regulatory the review of information submitted by agricultural input or product has come tolerance or action level has been the certifying agent and an on-site into contact with a prohibited substance exceeded. Test results that exceed review of the certifying agent’s or has been produced using excluded federal regulatory tolerances must also operation. Further, if certification is methods. Samples may include the be reported to the appropriate State denied, section 205.405(d) requires that collection and testing of soil; water; health agency or foreign equivalent. the certifying agent notify the applicant waste; seeds; plant tissue; and plant, Dated: November 5, 2012. of their right to file an appeal to the animal, and processed products David R. Shipman, AMS Administrator in accordance with samples. Such tests must be conducted section 205.681. These regulations by the applicable State organic Administrator, Agricultural Marketing Service. provide protections against program’s governing State official or the discrimination, thereby permitting all certifying agent at the official’s or [FR Doc. 2012–27378 Filed 11–8–12; 8:45 am] handlers, regardless of race, color, certifying agent’s own expense. BILLING CODE 3410–02–P national origin, gender, religion, age, (c) A certifying agent must conduct disability, political beliefs, sexual periodic residue testing of agricultural orientation, or marital or family status, products to be sold, labeled, or DEPARTMENT OF TRANSPORTATION who voluntarily choose to adhere to the represented as ‘‘100 percent organic,’’ Federal Aviation Administration final rule and qualify, to be certified as ‘‘organic,’’ or ‘‘made with organic meeting NOP requirements by an (specified ingredients or food 14 CFR Part 25 accredited certifying agent. This final group(s)).’’ Samples may include the rule in no way changes any of these collection and testing of soil; water; [Docket No. FAA–2012–1194; Special protections against discrimination. waste; seeds; plant tissue; and plant, Conditions No. 25–472–SC] animal, and processed products List of Subjects in 7 CFR Part 205 samples. Such tests must be conducted Special Conditions: Boeing Model 757 Administrative practice and by the certifying agent at the certifying Series Airplanes; Seats with Non- procedure, Agriculture, Animals, agent’s own expense. Traditional, Large, Non-Metallic Panels Archives and records, Imports, Labeling, (d) A certifying agent must, on an annual basis, sample and test from a AGENCY: Federal Aviation Organically produced products, Plants, Administration (FAA), DOT. Reporting and recordkeeping minimum of five percent of the ACTION: requirements, Seals and insignia, Soil operations it certifies, rounded to the Final special condition; request conservation. nearest whole number. A certifying for comments. agent that certifies fewer than thirty For the reasons set forth in the SUMMARY: These special conditions are operations on an annual basis must preamble, 7 CFR part 205 is amended as issued for the Boeing Model 757 series sample and test from at least one follows: airplanes. These airplanes as modified operation annually. Tests conducted under paragraphs (b) and (c) of this by Flight Structures, Inc. will have PART 205—NATIONAL ORGANIC novel or unusual design features PROGRAM section will apply to the minimum percentage of operations. associated with seats that include non- ■ 1. The authority citation for 7 CFR (e) Sample collection pursuant to traditional, large, non-metallic panels part 205 continues to read as follows: paragraphs (b) and (c) of this section that would affect survivability during a post-crash fire event. The applicable Authority: 7 U.S.C. 6501–6522. must be performed by an inspector representing the Administrator, airworthiness regulations do not contain ■ 2. Section 205.670 is revised to read applicable State organic program’s adequate or appropriate safety standards as follows: governing State official, or certifying for this design feature. These special agent. Sample integrity must be conditions contain the additional safety § 205.670 Inspection and testing of standards that the Administrator agricultural products to be sold or labeled maintained throughout the chain of as ‘‘100 percent organic,’’ ‘‘organic,’’ or custody, and residue testing must be considers necessary to establish a level ‘‘made with organic (specified ingredients performed in an accredited laboratory. of safety equivalent to that established or food group(s)).’’ Chemical analysis must be made in by the existing airworthiness standards. (a) All agricultural products that are accordance with the methods described DATES: The effective date of these to be sold, labeled, or represented as in the most current edition of the special conditions is November 5, 2012. ‘‘100 percent organic,’’ ‘‘organic,’’ or Official Methods of Analysis of the We must receive your comments by ‘‘made with organic (specified AOAC International or other current December 24, 2012. ingredients or food group(s))’’ must be applicable validated methodology for ADDRESSES: Send comments identified made accessible by certified organic determining the presence of by docket number [FAA–2012–1194] production or handling operations for contaminants in agricultural products. using any of the following methods: examination by the Administrator, the (f) Results of all analyses and tests • Federal eRegulations Portal: Go to applicable State organic program’s performed under this section will be http://www.regulations.gov/ and follow governing State official, or the certifying available for public access, unless the the online instructions for sending your agent. testing is part of an ongoing compliance comments electronically. (b) The Administrator, applicable investigation. Mail: Send comments to Docket State organic program’s governing State (g) If test results indicate a specific Operations, M–30, U.S. Department of official, or the certifying agent may agricultural product contains pesticide Transportation (DOT), 1200 New Jersey

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Avenue SE, Room W12–140, West conditions, explain the reason for any referred to as the ‘‘original type Building Ground Floor, Washington, recommended change, and include certification basis.’’ The regulations DC, 20590–0001. supporting data. incorporated by reference in Type Hand Delivery or Courier: Take We will consider all comments we Certificate No. A2NM are as follows: comments to Docket Operations in receive by the closing date for For Boeing Model 757–200 series Room W12–140 of the West Building comments. We may change these special airplanes—part 25, as amended by Ground Floor at 1200 New Jersey conditions based on the comments we Amendment 25–1 through Amendment Avenue SE., Washington, DC, between 8 receive. 25–45. In addition, an equivalent safety finding exists with respect to a.m. and 5 p.m., Monday through Background Friday, except federal holidays. § 25.853(c), Compartment interiors. Fax: Fax comments to Docket On April 5, 2012, Flight Structures, For Boeing Model 757–300 series Operations at 202–493–2251. Inc. applied for a supplemental type airplanes—part 25, as amended by Privacy: The FAA will post all certificate for installing seats that Amendment 25–1 through Amendment comments it receives, without change, include non-traditional, large, non- 25–85 with the exception listed: Section to http://www.regulations.gov/, metallic panels in Boeing Model 757 25.853(d)(3), Compartment interiors, at including any personal information the series airplanes. The Boeing Model 757 Amendment 25–72. commenter provides. Using the search series airplanes, currently approved If the Administrator finds that the function of the docket web site, anyone under Type Certificate No. A2NM, are applicable airworthiness regulations can find and read the electronic form of swept-wing, conventional tail, twin- (i.e., 14 CFR part 25) do not contain all comments received into any FAA engine, turbo-fan-powered, single aisle, adequate or appropriate safety standards docket, including the name of the medium-sized transport category for the Boeing Model 757 series individual sending the comment (or airplanes. airplanes because of a novel or unusual The applicable regulations to signing the comment for an association, design feature, special conditions are airplanes currently approved under business, labor union, etc.). DOT’s prescribed under the provisions of Type Certificate No. A2NM do not complete Privacy Act Statement can be § 21.16. require seats to meet the more stringent found in the Federal Register published Special conditions are initially flammability standards required of on April 11, 2000 (65 FR 19477–19478), applicable to the model for which they large, non-metallic panels in the cabin as well as at http://DocketsInfo.dot.gov/. are issued. Should the applicant apply interior. At the time the applicable rules Docket: Background documents or for a supplemental type certificate to were written, seats were designed with comments received may be read at modify any other model included on the a metal frame covered by fabric, not http://www.regulations.gov/ at any time. same type certificate to incorporate the with large, non-metallic panels. Seats Follow the online instructions for same novel or unusual design feature, also met the then-recently-adopted accessing the docket or go to the Docket the special conditions would also apply standards for flammability of seat Operations in Room W12–140 of the to the other model. cushions. With the seat design being West Building Ground Floor at 1200 In addition to the applicable mostly fabric and metal, the New Jersey Avenue SE., Washington, airworthiness regulations and special contribution to a fire in the cabin had DC, between 9 a.m. and 5 p.m., Monday conditions, the Boeing Model 757 series been minimized and was not considered through Friday, except federal holidays. airplanes must comply with the fuel a threat. For these reasons, seats did not vent and exhaust emission requirements FOR FURTHER INFORMATION CONTACT: John need to be tested to heat release and of 14 CFR part 34 and the noise Shelden, FAA, Airframe and Cabin smoke emission requirements. certification requirements of 14 CFR Safety Branch, ANM–115, Transport Seat designs have now evolved to part 36. Airplane Directorate, Aircraft occasionally include non-traditional, The FAA issues special conditions, as Certification Service, 1601 Lind Avenue large, non-metallic panels. Taken in defined in 14 CFR 11.19, in accordance SW., Renton, Washington 98057–3356; total, the surface area of these panels is with § 11.38, and they become part of telephone 425–227–2785; facsimile 425 on the same order as the sidewall and the type-certification basis under 227–1232; email [email protected]. overhead stowage bin interior panels. § 21.101. SUPPLEMENTARY INFORMATION: The FAA To provide the level of passenger has determined that notice of, and protection intended by the Novel or Unusual Design Features opportunity for prior public comment airworthiness standards, these non- The Boeing Model 757 series on, these special conditions are traditional, large, non-metallic panels in airplanes will incorporate the following impracticable because these procedures the cabin must meet the standards of novel or unusual design features: These would significantly delay issuance of Title 14, Code of Federal Regulations models offer interior arrangements that the design approval and thus delivery of (14 CFR), part 25, Appendix F, parts IV include passenger seats that incorporate the affected aircraft. In addition, the and V, heat release and smoke emission non-traditional, large, non-metallic substance of these special conditions requirements. panels in lieu of the traditional metal has been subject to the public comment frame covered by fabric. The process in several prior instances with Type Certification Basis flammability properties of these panels no substantive comments received. The Under the provisions of § 21.101, have been shown to significantly affect FAA therefore finds that good cause Flight Structures, Inc. must show that the survivability of the cabin in the case exists for making these special the Boeing Model 757 series airplanes, of fire. These seats are considered a conditions effective upon issuance. as changed, continue to meet the novel design for transport category applicable provisions of the regulations airplanes that include Amendment 25– Comments Invited incorporated by reference in Type 61 and Amendment 25–66 in the We invite interested people to take Certificate No. A2NM or the applicable certification basis, and were not part in this rulemaking by sending regulations in effect on the date of considered when those airworthiness written comments, data, or views. The application for the change. The standards were established. most helpful comments reference a regulations incorporated by reference in The existing regulations do not specific portion of the special the type certificate are commonly provide adequate or appropriate safety

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standards for seat designs that approximately two minutes over incorporated non-traditional, large, non- incorporate non-traditional, large, non- materials that do not comply. metallic panels in lieu of the traditional metallic panels in their designs. In order At the time these standards were metal covered by fabric. The Seattle to provide a level of safety that is written, the potential application of the Aircraft Certification Office and equivalent to that afforded to the requirements of heat release and smoke Transport Standards Staff reviewed this balance of the cabin, additional emission to seats was explored. The seat design and determined that it airworthiness standards, in the form of frame itself was not a concern because represented the kind and quantity of special conditions, are necessary. These it was primarily made of aluminum and material that should be required to pass special conditions supplement § 25.853. there were only small amounts of non- the heat release and smoke emissions The requirements contained in these metallic materials. It was determined requirements. We have determined that special conditions consist of applying that the overall effect on survivability special conditions would be the identical test conditions required of was negligible, whether or not the food promulgated to apply the standards all other large panels in the cabin, to trays met the heat release and smoke defined in § 25.853(d) to seats with seats with non-traditional, large, non- requirements. The requirements large, non-metallic panels in their metallic panels. therefore did not address seats. The design. A non-traditional, large, non-metallic preambles to both the Notice of panel, in this case, is defined as a panel Proposed Rule Making, Notice No. 85– Applicability with exposed-surface areas greater than 10 (50 FR 15038, April 16, 1985) and the As discussed above, these special 1.5 square feet installed per seat place. Final Rule at Amendment 25–61 (51 FR conditions are applicable to the Boeing The panel may consist of either a single 26206, July 21, 1986), specifically note Model 757 series airplanes. Should component or multiple components in a that seats were excluded ‘‘because the Flight Structures, Inc. apply at a later concentrated area. Examples of parts of recently-adopted standards for date for a supplemental type certificate the seat where these non-traditional flammability of seat cushions will to modify any other model included on panels are installed include, but are not greatly inhibit involvement of the Type Certificate No. A2NM to limited to seat backs, bottoms and leg/ seats.’’ incorporate the same novel or unusual foot rests, kick panels, back shells, Subsequently, the Final Rule at design feature, the special conditions credenzas and associated furniture. Amendment 25–83 (60 FR 6615, March would apply to that model as well. 6, 1995) clarified the definition of Examples of traditional exempted parts Conclusion of the seat include: arm caps, armrest minimum panel size: ‘‘It is not possible close-outs such as end bays and armrest- to cite a specific size that will apply in This action affects only certain novel styled center consoles, food trays, video all installations; however, as a general or unusual design features on the monitors, and shrouds. rule, components with exposed-surface Boeing Model 757 series of airplanes. It areas of one square foot or less may be is not a rule of general applicability and Clarification of ‘‘Exposed’’ considered small enough that they do affects only the applicant who applied ‘‘Exposed’’ is considered to include not have to meet the new standards. to the FAA for approval of these features panels that are directly exposed to the Components with exposed-surface areas on the airplane. passenger cabin in the traditional sense, greater than two square feet may be The substance of these special and panels that are enveloped, such as considered large enough that they do conditions has been subjected to the by a dress cover. Traditional fabrics or have to meet the new standards. Those notice and comment period in several leathers currently used on seats are with exposed-surface areas greater than prior instances and has been derived excluded from these special conditions. one square foot, but less than two square without substantive change from those These materials must still comply with feet, must be considered in conjunction previously issued. It is unlikely that § 25.853(a) and § 25.853(c) if used as a with the areas of the cabin in which prior public comment would result in a covering for a seat cushion, or they are installed before a determination significant change from the substance § 25.853(a) if installed elsewhere on the could be made.’’ contained herein. Therefore, because a seat. Non-traditional, large, non-metallic In the late 1990s, the FAA issued delay would significantly affect the panels covered with traditional fabrics Policy Memorandum 97–112–39, certification of the airplane, which is or leathers will be tested without their Guidance for Flammability Testing of imminent, the FAA has determined that coverings or covering attachments. Seat/Console Installations, October 17, prior public notice and comment are 1997. That memo was issued when it unnecessary and impracticable, and Discussion became clear that seat designs were good cause exists for adopting these In the early 1980s, the FAA evolving to include large, non-metallic special conditions upon issuance. The conducted extensive research on the panels with surface areas that would FAA is requesting comments to allow effects of post-crash flammability in the impact survivability during a cabin fire interested persons to submit views that passenger cabin. As a result of this event, comparable to partitions or may not have been submitted in research and service experience, the galleys. The memo noted that large response to the prior opportunities for FAA adopted new standards for interior surface area panels must comply with comment described above. surfaces associated with large surface heat release and smoke emission List of Subjects in 14 CFR Part 25 area parts. Specifically, the rules require requirements, even if they were attached measurement of heat release and smoke to a seat. Aircraft, Aviation safety, Reporting emission (part 25, Appendix F, parts IV If the FAA had not issued such and recordkeeping requirements. and V) for the affected parts. Heat policy, seat designs could have been The authority citation for these release has been shown to have a direct viewed as a loophole to the special conditions is as follows: correlation with post-crash fire survival airworthiness standards that would Authority: 49 U.S.C. 106(g), 40113, 44701, time. Materials that comply with the result in an unacceptable decrease in 44702, 44704. standards (i.e., § 25.853 titled survivability during a cabin fire event. ‘‘Compartment interiors’’ as amended by In October 2004, an issue was raised The Special Conditions Amendment 25–61 and Amendment regarding the appropriate flammability Accordingly, pursuant to the 25–66) extend survival time by standards for passenger seats that authority delegated to me by the

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Administrator, the following special ACTION: Final rule. An investigation revealed that inadequate conditions are issued as part of the type clearance between the wires and metallic certification basis for Boeing Model 757 SUMMARY: We are adopting a new structure within the ACCB could cause series airplanes modified by Flight airworthiness directive (AD) for certain chafed wires. Structures, Inc. Bombardier, Inc. Model DHC–8–400, Damaged, chafed or loose wiring within an –401, and –402 airplanes. This AD was ACCB could affect the operation of the Seats With Non-Traditional, Large, prompted by reports of an in-service windshield heater, ice detector, angle of Non-Metallic Panels incident where the propeller de-icing attack (AOA) vane heater, pitot probe heater, system became unavailable due to engine intake heater or propeller de-icing 1. Except as provided in paragraph 3 system. Loss of one of these systems could of these special conditions, compliance burnt/chafed wires within the adversely affect the aeroplane’s flight with 14 CFR part 25, Appendix F, parts alternating current contactor box characteristics in icing conditions. IV and V, heat release and smoke (ACCB). This AD requires inspection for This [Transport Canada Civil Aviation emission, is required for seats that chafing, damage, and loose wiring (TCCA)] Airworthiness Directive (AD) incorporate non-traditional, large, non- within an ACCB and repair if necessary; mandates the [visual] inspection [for metallic panels that may either be a and requires rework and re- damaged, chafed, and loose wiring within an single component or multiple identification of the wiring installation ACCB and replace if necessary] and within each ACCB. We are issuing this rectification [rework] of the wiring components in a concentrated area in installation within each ACCB. their design. AD to detect and correct damaged, 2. The applicant may designate up to chafed, or loose wiring within an ACCB, You may obtain further information by and including 1.5 square feet of non- which could affect the operation of the examining the MCAI in the AD docket. windshield heater, ice detector, angle of traditional, non-metallic panel material Comments per seat place that does not have to attack (AOA) vane heater, pilot probe comply with special condition Number heater, engine intake heater, or propeller We gave the public the opportunity to 1, above. A triple seat assembly may de-icing system, and subsequently participate in developing this AD. We have a total of 4.5 square feet excluded adversely affect the airplane’s flight received no comments on the NPRM (77 on any portion of the assembly (e.g., characteristics in icing conditions. FR 49394, August 16, 2012) or on the outboard seat place 1 square foot, DATES: This AD becomes effective determination of the cost to the public. middle 1 square foot, and inboard 2.5 December 14, 2012. Conclusion square feet). The Director of the Federal Register 3. Seats do not have to meet the test approved the incorporation by reference We reviewed the available data and requirements of 14 CFR part 25, of certain publications listed in this AD determined that air safety and the Appendix F, parts IV and V, when as of December 14, 2012. public interest require adopting the AD installed in compartments that are not ADDRESSES: You may examine the AD as proposed—except for minor editorial otherwise required to meet these docket on the Internet at http:// changes. We have determined that these requirements. Examples include: www.regulations.gov or in person at the minor changes: • a. Airplanes with passenger capacities U.S. Department of Transportation, Are consistent with the intent that of 19 or less, Docket Operations, M–30, West was proposed in the NPRM (77 FR b. Airplanes that do not have § 25.853, Building Ground Floor, Room W12–140, 49394, August 16, 2012) for correcting Amendment 25–61 or later, in their 1200 New Jersey Avenue SE., the unsafe condition; and • certification basis and do not need to Washington, DC. Do not add any additional burden comply with the requirements of 14 CFR FOR FURTHER INFORMATION CONTACT: upon the public than was already 121.312, and Assata Dessaline, Aerospace Engineer, proposed in the NPRM (77 FR 49394, c. Airplanes exempted from § 25.853, Avionics and Flight Test Branch, ANE– August 16, 2012). Amendment 25–61 or later. 172, FAA, New York Aircraft Costs of Compliance Issued in Renton, Washington, on Certification Office (ACO), 1600 Stewart November, 5, 2012. Avenue, Suite 410, Westbury, New York We estimate that this AD will affect Ali Bahrami, 11590; telephone (516) 228–7301; fax 83 products of U.S. registry. We also Manager, Transport Airplane Directorate, (516) 794–5531. estimate that it will take about 7 work- hours per product to comply with the Aircraft Certification Service. SUPPLEMENTARY INFORMATION: [FR Doc. 2012–27370 Filed 11–8–12; 8:45 am] basic requirements of this AD. The average labor rate is $85 per work-hour. BILLING CODE 4910–13–P Discussion We issued a notice of proposed Based on these figures, we estimate the rulemaking (NPRM) to amend 14 CFR cost of this AD to the U.S. operators to DEPARTMENT OF TRANSPORTATION part 39 to include an AD that would be $49,385, or $595 per product. apply to the specified products. That In addition, we estimate that any Federal Aviation Administration NPRM was published in the Federal necessary follow-on actions would take Register on August 16, 2012 (77 FR about 2 work-hours and require parts 14 CFR Part 39 49394). That NPRM proposed to correct costing $0, for a cost of $170 per [Docket No. FAA–2012–0806; Directorate an unsafe condition for the specified product. We have no way of Identifier 2012–NM–022–AD; Amendment products. The Mandatory Continuing determining the number of products 39–17243; AD 2012–22–07] Airworthiness Information (MCAI) that may need these actions. RIN 2120–AA64 states: Authority for This Rulemaking There has been one (1) reported in-service Airworthiness Directives; Bombardier, Title 49 of the United States Code incident where the propeller de-icing system specifies the FAA’s authority to issue Inc. Airplanes became unavailable due to burnt/chafed wires within the Alternating Current rules on aviation safety. Subtitle I, AGENCY: Federal Aviation Contactor Box (ACCB). There has also been section 106, describes the authority of Administration (FAA), Department of a number of additional minor events of wires the FAA Administrator. ‘‘Subtitle VII: Transportation (DOT). found chafed within ACCBs. Aviation Programs,’’ describes in more

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detail the scope of the Agency’s the FAA amends 14 CFR part 39 as (1) Bombardier Service Bulletin 84–24–47, authority. follows: Revision A, dated September 14, 2011. We are issuing this rulemaking under (2) Bombardier Service Bulletin 84–24–48, the authority described in ‘‘Subtitle VII, PART 39—AIRWORTHINESS Revision A, dated September 14, 2011. Part A, Subpart III, Section 44701: DIRECTIVES (3) Bombardier Service Bulletin 84–24–49, Revision A, dated September 14, 2011. General requirements.’’ Under that ■ 1. The authority citation for part 39 (4) Bombardier Service Bulletin 84–24–50, section, Congress charges the FAA with Revision A, dated September 14, 2011. promoting safe flight of civil aircraft in continues to read as follows: air commerce by prescribing regulations Authority: 49 U.S.C. 106(g), 40113, 44701. (h) Parts Installation Prohibition for practices, methods, and procedures As of the effective date of this AD, no the Administrator finds necessary for § 39.13 [Amended] person may install an ACCB having the safety in air commerce. This regulation ■ 2. The FAA amends § 39.13 by adding combination of part numbers (P/N) and series is within the scope of that authority the following new AD: specified in paragraphs (h)(1), (h)(2), (h)(3), and (h)(4) of this AD on any airplane. because it addresses an unsafe condition 2012–22–07 Bombardier, Inc.: Amendment (1) P/N 1152130–6, series 1, 2, and 4. that is likely to exist or develop on 39–17243. Docket No. FAA–2012–0806; (2) P/N 1152148–6, series 1, 2, 4, and 5. products identified in this rulemaking Directorate Identifier 2012–NM–022–AD. (3) P/N 1152090–6, series 1, 2, and 4. action. (a) Effective Date (4) P/N 1152124–6, series 1, 2, 4, and 5. Regulatory Findings This airworthiness directive (AD) becomes (i) Credit for Previous Actions We determined that this AD will not effective December 14, 2012. This paragraph provides credit for the actions required by paragraph (g) of this AD, have federalism implications under (b) Affected ADs if those actions were performed before the Executive Order 13132. This AD will None. not have a substantial direct effect on effective date of this AD using the applicable (c) Applicability service bulletin specified in paragraphs (i)(1) the States, on the relationship between through (i)(4) of this AD, which are not the national government and the States, This AD applies to Bombardier, Inc. Model incorporated by reference in this AD. or on the distribution of power and DHC–8–400, –401, and –402 airplanes, (1) Bombardier Service Bulletin 84–24–47, responsibilities among the various certificated in any category, serial numbers dated April 26, 2011. levels of government. 4001 and subsequent. (2) Bombardier Service Bulletin 84–24–48, For the reasons discussed above, I (d) Subject dated April 26, 2011. certify that this AD: (3) Bombardier Service Bulletin 84–24–49, Air Transport Association (ATA) of dated April 26, 2011. 1. Is not a ‘‘significant regulatory America Code 24: Electrical Power. action’’ under Executive Order 12866; (4) Bombardier Service Bulletin 84–24–50, 2. Is not a ‘‘significant rule’’ under the (e) Reason dated April 26, 2011. DOT Regulatory Policies and Procedures This AD was prompted by reports of an in- (j) Other FAA AD Provisions (44 FR 11034, February 26, 1979); service incident where the propeller de-icing The following provisions also apply to this 3. Will not affect intrastate aviation in system became unavailable due to burnt/ AD: Alaska; and chafed wires within the alternating current (1) Alternative Methods of Compliance 4. Will not have a significant contactor box (ACCB) due to inadequate (AMOCs): The Manager, New York Aircraft economic impact, positive or negative, clearance. We are issuing this AD to detect Certification Office (ACO), ANE–170, FAA, on a substantial number of small entities and correct damaged, chafed, or loose wiring has the authority to approve AMOCs for this under the criteria of the Regulatory within an ACCB, which could affect the AD, if requested using the procedures found operation of the windshield heater, ice in 14 CFR 39.19. In accordance with 14 CFR Flexibility Act. detector, angle of attack (AOA) vane heater, We prepared a regulatory evaluation 39.19, send your request to your principal pilot probe heater, engine intake heater, or inspector or local Flight Standards District of the estimated costs to comply with propeller de-icing system, and subsequently Office, as appropriate. If sending information this AD and placed it in the AD docket. adversely affect the airplane’s flight directly to the ACO, send it to ATTN: Examining the AD Docket characteristics in icing conditions. Program Manager, Continuing Operational (f) Compliance Safety, FAA, New York ACO, 1600 Stewart You may examine the AD docket on Avenue, Suite 410, Westbury, New York the Internet at http:// You are responsible for having the actions 11590; telephone 516–228–7300; fax 516– www.regulations.gov; or in person at the required by this AD performed within the 794–5531. Before using any approved AMOC, Docket Operations office between 9 a.m. compliance times specified, unless the notify your appropriate principal inspector, and 5 p.m., Monday through Friday, actions have already been done. or lacking a principal inspector, the manager except Federal holidays. The AD docket (g) Inspection of the local flight standards district office/ contains the NPRM (77 FR 49394, certificate holding district office. The AMOC For airplanes having serial numbers 4001 approval letter must specifically reference August 16, 2012), the regulatory through 4354 inclusive, and 4356 through this AD. evaluation, any comments received, and 4366 inclusive: Within 6,000 flight hours or (2) Airworthy Product: For any requirement other information. The street address for 36 months after the effective date of this AD, in this AD to obtain corrective actions from the Docket Operations office (telephone whichever occurs first: Do a general visual a manufacturer or other source, use these (800) 647–5527) is in the ADDRESSES inspection for chafing, damage, and actions if they are FAA-approved. Corrective section. Comments will be available in insulation damage, and rework the wiring actions are considered FAA-approved if they the AD docket shortly after receipt. within the ACCB, in accordance with the are approved by the State of Design Authority Accomplishment Instructions of the (or their delegated agent). You are required List of Subjects in 14 CFR Part 39 applicable Bombardier service bulletin to assure the product is airworthy before it specified in paragraphs (g)(1) through (g)(4) is returned to service. Air transportation, Aircraft, Aviation of this AD. If any chafing, damage, or safety, Incorporation by reference, insulation damage is found, before further (k) Related Information Safety. flight, replace the damaged wiring, in (1) Refer to MCAI Canadian Airworthiness Adoption of the Amendment accordance with the Accomplishment Directive CF–2012–03, dated January 11, Instructions of the applicable Bombardier 2012, and the service information specified Accordingly, under the authority service bulletin specified in paragraphs (g)(1) in paragraphs (k)(1)(i) through (k)(1)(iv) of delegated to me by the Administrator, through (g)(4) of this AD. this AD, for related information.

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(i) Bombardier Service Bulletin 84–24–47, DEPARTMENT OF TRANSPORTATION evaluation, any comments received, and Revision A, dated September 14, 2011. other information. The address for the (ii) Bombardier Service Bulletin 84–24–48, Federal Aviation Administration Docket Office (phone: 800–647–5527) is Revision A, dated September 14, 2011. Document Management Facility, U.S. (iii) Bombardier Service Bulletin 84–24–49, 14 CFR Part 39 Department of Transportation, Docket Revision A, dated September 14, 2011. [Docket No. FAA–2011–0518; Directorate Operations, M–30, West Building (iv) Bombardier Service Bulletin 84–24–50, Identifier 2010–NM–150–AD; Amendment Ground Floor, Room W12–140, 1200 Revision A, dated September 14, 2011. 39–17231; AD 2012–21–15] New Jersey Avenue SE., Washington, (2) For service information identified in DC 20590. this AD, contact Bombardier, Inc., Q-Series RIN 2120–AA64 Technical Help Desk, 123 Garratt Boulevard, FOR FURTHER INFORMATION CONTACT: Dan Toronto, Ontario M3K 1Y5, Canada; Airworthiness Directives; Airbus Rodina, Aerospace Engineer, telephone 416–375–4000; fax 416–375–4539; Airplanes International Branch, ANM–116, Transport Airplane Directorate, FAA, email [email protected]; AGENCY: Federal Aviation Internet http://www.bombardier.com. 1601 Lind Avenue SW., Renton, Administration (FAA), DOT. Washington 98057–3356; telephone (l) Material Incorporated by Reference ACTION: Final rule. 425–227–2125; fax 425–227–1149. (1) The Director of the Federal Register SUMMARY: We are adopting a new SUPPLEMENTARY INFORMATION: approved the incorporation by reference airworthiness directive (AD) for all (IBR) of the service information listed in this Discussion Airbus Model A300 B4–600, B4–600R, paragraph under 5 U.S.C. 552(a) and 1 CFR We issued a notice of proposed part 51. and F4–600R series airplanes, and rulemaking (NPRM) to amend 14 CFR (2) You must use this service information Model A300 C4–605R Variant F part 39 to include an AD that would as applicable to do the actions required by airplanes (collectively called A300–600 apply to the specified products. That this AD, unless the AD specifies otherwise. series airplanes); and Model A310 series NPRM published in the Federal (i) Bombardier Service Bulletin 84–24–47, airplanes. This AD was prompted by Revision A, dated September 14, 2011. events of excessive rudder pedal inputs Register on May 19, 2011 (76 FR 28914). (ii) Bombardier Service Bulletin 84–24–48, and consequent high loads on the That NPRM proposed to require Revision A, dated September 14, 2011. vertical stabilizer on several airplanes. incorporating a design change to the (iii) Bombardier Service Bulletin 84–24–49, This AD requires either incorporating a rudder control system and/or other Revision A, dated September 14, 2011. design change to the rudder control systems to address the unsafe condition. (iv) Bombardier Service Bulletin 84–24–50, system and/or other systems, or Relevant Service Information Revision A, dated September 14, 2011. installing a stop rudder inputs warning (3) For service information identified in (SRIW) modification. We are issuing Since we issued the NPRM (76 FR this AD, contact Bombardier, Inc., Q-Series this AD to prevent loads on the vertical 28914, May 19, 2011), Airbus has issued Technical Help Desk, 123 Garratt Boulevard, stabilizer that exceed ultimate design the following service information: Toronto, Ontario M3K 1Y5, Canada; loads, which could cause failure of the • Airbus Mandatory Service Bulletin telephone 416–375–4000; fax 416–375–4539; vertical stabilizer and consequent A300–22–6055, Revision 01, including email [email protected]; reduced controllability of the airplane. Appendix 01, dated May 31, 2012 Internet http://www.bombardier.com. DATES: This AD is effective December • Airbus Service Bulletin A300–22– (4) You may review copies of the service 14, 2012. 6054, including Appendix 01, dated information at the FAA, Transport Airplane The Director of the Federal Register June 20, 2012 Directorate, 1601 Lind Avenue SW., Renton, approved the incorporation by reference • Airbus Service Bulletin A300–22– WA. For information on the availability of of certain publications listed in the AD 6056, dated April 25, 2012 this material at the FAA, call 425–227–1221. as of December 14, 2012. • (5) You may view this service information Airbus Service Bulletin A300–31– ADDRESSES: For the service information that is incorporated by reference at the 6140, dated May 4, 2012 identified in this AD, contact Airbus National Archives and Records • Airbus Mandatory Service Bulletin SAS—EAW (Airworthiness Office), 1 Administration (NARA). For information on A310–22–2064, Revision 01, including Rond Point Maurice Bellonte, 31707 the availability of this material at NARA, call Appendix 01, dated May 31, 2012 Blagnac Cedex, France; telephone +33 5 202–741–6030, or go to: http:// • Airbus Service Bulletin A310–22– 61 93 36 96; fax +33 5 61 93 44 51; email www.archives.gov/federal-register/cfr/ibr- 2063, including Appendix 01, dated [email protected]; locations.html. June 20, 2012 Internet http://www.airbus.com. You • Issued in Renton, Washington, on October may review copies of the referenced Airbus Service Bulletin A310–22– 24, 2012. service information at the FAA, 2065, dated April 25, 2012 • Kalene C. Yanamura, Transport Airplane Directorate, 1601 Airbus Service Bulletin A310–31– Acting Manager, Transport Airplane Lind Avenue SW., Renton, Washington. 2144, dated May 4, 2012 Directorate, Aircraft Certification Service. For information on the availability of These service bulletins describe [FR Doc. 2012–26774 Filed 11–8–12; 8:45 am] this material at the FAA, call 425–227– procedures related to the SRIW modification. The procedures include BILLING CODE 4910–13–P 1221. installing a SRIW device, activating the Examining the AD Docket SRIW device, upgrading the flight You may examine the AD docket on control computer to introduce the SRIW the Internet at http:// logic, and upgrading the flight warning www.regulations.gov; or in person at the computer. We have revised paragraph Docket Management Facility between 9 (g) in this final rule to allow a.m. and 5 p.m., Monday through accomplishment of this modification as Friday, except Federal holidays. The AD an optional method of compliance with docket contains this AD, the regulatory the requirements of the AD.

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Comments and A310 rudder pedal sensitivity, we however, the intent of this AD is to We gave the public the opportunity to disagree to withdraw the NPRM (76 FR require a design change be made to the participate in developing this AD. The 28914, May 19, 2011). The National airplane to correct the unsafe condition. following presents the comments Transportation Safety Board (NTSB) We have not changed this final rule received on the proposal (76 FR 28914, found that the rudder pedal’s sensitivity regarding this issue. contributed to the American Airlines May 19, 2011) and the FAA’s response Request for Alternative Solution flight 587 accident, and, during a recent to each comment. upset on an airplane with a similar Airbus suggested that, in lieu of the Support for the NPRM (76 FR 28914, system, the pilot made excessive pedal PTLU design modification discussed in May 19, 2011) input, thinking he was actually the NPRM (76 FR 28914, May 19, 2011), we revise the NPRM to add another way The National Transportation Safety correcting an airplane malfunction. Even with significant emphasis on to comply—by installing a warning light Board (NTSB) and Air Line Pilots on the glareshield directly in front of Association, International (ALPA), training and rudder pedal sensitivity awareness, however, there have been each pilot and an associated ‘‘stop support the intent of the NPRM (76 FR rudder inputs’’ aural warning, in 28914, May 19, 2011). additional full rudder pedal reversal occurrences on airplanes with similar addition to revising the airplane flight Requests To Withdraw NPRM (76 FR rudder control systems. We have manual and reinforced flightcrew 28914, May 19, 2011): Unjustifiable concluded that training alone is training. Airbus noted that flightcrew Burden on Operators inadequate, and we have determined failure to use proper techniques was a that a modification such as the pedal contributing factor to the excessive UPS and FedEx requested that we rudder pedal inputs. withdraw the NPRM (76 FR 28914, May travel limiter unit (PTLU) or other design modification is necessary to According to Airbus, its warning 19, 2011). system will deter pilots from continuing UPS stated that, in light of its existing address the unsafe condition. We have not changed the final rule regarding this the application of rapid alternating and operational and monitoring processes, large rudder pedal inputs, and is a more the cost of the NPRM (76 FR 28914, May issue. Based on the best information available on possible flightcrew training suitable solution than the PTLU 19, 2011) would be a severe and and possible design modifications, we modification proposed by the FAA. unnecessary burden relative to its have identified the need to incorporate We acknowledge Airbus’s suggested benefit. UPS stated that its flightcrews a design change that will further address solution, which was unavailable for operate the airplanes in a manner that this unsafe condition. In addition, the consideration at the time we issued the would not warrant the need for the FAA has tasked a joint authority- NPRM (76 FR 28914, May 19, 2011). proposed systems. UPS described its industry group to recommend criteria Following the receipt of the Airbus A300 flight training program, flight that might be used to evaluate other comments, the FAA has evaluated the operations quality assurance (FOQA) models. Upon acceptance of appropriate Airbus alternative and found the ‘‘stop program, and manual changes that were criteria, the FAA will begin to assess rudder inputs’’ warning (SRIW) prompted by the incidents, and added other in-service airplanes. Currently, the modification combined with suitable that its training and awareness programs group is scheduled to complete its work flightcrew training programs provides have been enhanced to specifically in late 2013. See the FAA’s response to an acceptable mitigation for the unsafe address the inherent high-speed the comments under ‘‘Request to condition. As stated previously, we sensitivity or response of the A300 Expand Applicability’’ in this final rule. agree to change this final rule to allow rudder control system. UPS concluded the SRIW modification as an optional that its flight training program Request To Emphasize Training method of compliance with the emphasizes proper use of the rudder for In addition to supporting design requirements of the AD. In addition, which the rudder has been certified, and enhancements to prevent inadvertent since we issued the NPRM, the its robust FOQA program coupled with rudder over control, ALPA stated there European Aviation Safety Agency a review of maximum lateral loading should continue to be emphasis on the (EASA), which is the Technical Agent from actual flights demonstrates that appropriate use of rudder in training for the Member States of the European UPS flightcrews do not induce heavy programs. Community, has issued EASA AD 2012– side loading with improper rudder use. The FAA agrees with the commenter 0088, dated June 25, 2012, to require In addition, UPS stated that the FAA that training programs are beneficial. installation of the SRIW modification on has already taken numerous actions to Since the American Airlines Flight 587 Model A300–600 and A310 series address this safety issue. accident, the FAA has emphasized airplanes to address this unsafe FedEx stated that its current training with letters to all affected condition. flightcrew training practices have operators notifying them of concerns ensured elimination of excessive rudder regarding the need for industry-wide Requests for Alternative Compliance pedal inputs on FedEx’s Model A300– pilot knowledge and training on proper Method 600 and A310 series airplanes. FedEx use of rudder pedals, in addition to the Francis Gentile requested that we further detailed that it has monitored potential consequences of some revise the NPRM (76 FR 28914, May 19, and recorded events of lateral G maneuvers that might exceed the 2011) to include, as one way to comply exceedences at FedEx as a result of FAA structural limits of the vertical tail. The with the NPRM, the option to tape a AD 2002–06–09, Amendment 39–12686 FAA also tasked a working group to yaw string onto the front windows to (67 FR 13259, March 22, 2002; corrected help develop specific training programs give the pilot maximum feedback at 67 FR 51459, August 8, 2002), and all for rudder usage on all transport against excessive yaw and pilot-induced such events have been a result of category airplanes. The FAA has also oscillation. something other than pilot rudder pedal added language in section 25.1583(a)(3) We disagree with this request. The input. of the Federal Aviation Regulations (14 unsafe condition presents itself with Although the FAA agrees with the CFR 25.1583(a)(3)) to warn against dynamic yaw excursions linked to importance of enhanced training and control reversals. Training will continue rudder pedal reversals. Yaw indicators operational awareness of Model A300 to be emphasized in the future; already present on the flight deck have

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not proven effective in previous rudder Recommendation A–04–56 recommends requested that we extend the proposed pedal reversal events. developing a revised standard to ensure compliance time to 72 months to allow Mr. Gentile also suggested adhering a safe handling qualities in the yaw axis time to revise the master minimum pointed cone on each rudder pedal to throughout the flight envelope, equipment list (MMEL) to support give the pilot the progressive feedback including limits for rudder pedal dispatch reliability of the newly sensation of force applied to the pedal sensitivity. Currently an FAA aviation installed system. UPS stated that at least and possibly cause pain in the ball of rulemaking advisory committee (ARAC) 6 years would be needed to install the the foot or a twisting ankle to deter the has been assigned to evaluate this safety PTLU on its fleet. pilot from making inputs or at least alert recommendation. Pending the ARAC We disagree with the FedEx proposal. the pilot to stop making such an input. recommendation, the FAA will In determining the appropriate The commenter pointed out that this determine whether other airplanes have compliance time for this AD, we solution might be less expensive than a similar unsafe condition that needs to considered many factors, including the proposed modification. The be addressed by rulemaking or those related to maintenance program commenter noted that the cone might airworthiness actions. We have not adjustments. Further, once the PTLU is also interfere with other pedal functions changed the final rule regarding this developed and ready for incorporation such as braking. issue. on the fleet, operators may request We do not agree with this comment. MMEL relief via an AMOC request to The commenter has provided an Request To Remove Model A310–200 the AD. We determined that the unproven design suggestion. There is no Airplanes From Applicability compliance time, as proposed, will evidence that such devices would be Airbus requested that we revise the maintain the necessary level of safety effective at preventing the unsafe applicability of the NPRM (76 FR 28914, and allow adequate time for operators to condition. The rudder pedals are used May 19, 2011) to remove Model A310– modify their maintenance program. We normally for taxiing and flying the 200 airplanes because their remaining have not changed the final rule airplane. Adding cone devices to the service life is short. regarding this issue. pedals may interfere with normal pedal We disagree with the request. Service usage. There are certain safety-critical life projections vary among operators Request To Extend Compliance Time: conditions where it is necessary for the and are difficult to accurately Account for Design Service Goals pilot to apply rapid hard pedal inputs. determine. Airbus did not provide any Airbus requested that we revise the Anything that interferes with the pilot’s specific service life projections. In proposed compliance time to consider ability to make necessary inputs could addition, the utilization rate of these the Airbus design service goals (DSGs) reduce safety. Such devices might also airplanes is low, which can preserve for the affected airplanes. Airbus defeat the purpose of the pedal and extend their life. We therefore do provided a proposed grace period for adjustment feature that allows shorter or not consider this request to have any airplane close to its DSG value near taller pilots to use the pedal, and affect adequate justification. We have not the end of the compliance time, until appropriate steering and braking. Under changed the final rule regarding this the airplane’s certificate of the provisions of paragraph (h) of this issue. airworthiness is withdrawn. AD, however, we will consider requests We disagree with the request. This AD for approval of different compliance Request To Revise Compliance Time: includes all airplanes that have the methods if sufficient data are submitted Account for PTLU Development Time defined unsafe condition regardless if to substantiate that the change would FedEx requested that we extend the the airplane is currently in operation, or provide an acceptable level of safety. proposed compliance time to account has been removed from service. As We have not changed the AD for development time for the PTLU. Airbus has described the operators may regarding these issues. We disagree with the request. We choose to further invest in the airplanes have determined that the unsafe and operate them in what Airbus calls Request To Expand Applicability condition warrants corrective action the extended service goals (ESG). This Airbus questioned the basis for the within the specified time frame. If AD does not prevent an airplane from NPRM (76 FR 28914, May 19, 2011)— developing the PTLU and incorporating being operated beyond the DSG so a that rudder pedal sensitivity is limited the mandated changes require grace period for any airplane close to its to Model A300–600 and A310 series additional time, the FAA may consider DSG does not maintain an adequate airplanes. Airbus added that rapid revising the AD to extend the level of safety. Under the provisions of alternating and large pilot rudder inputs compliance time, or provide such relief paragraph (h) of this final rule, however, while enroute are inappropriate and through approval of an AMOC to extend we will consider requests to approve an have the potential to be unsafe for a the compliance time of the AD extension of the compliance time if wider fleet of large transport airplanes. according to the provisions of paragraph sufficient data are submitted to Airbus identified several resources (h) of this AD. We have not changed the substantiate that the extension would supporting this position. final rule regarding this issue. also provide an acceptable level of We infer that Airbus wants us to Request To Revise Compliance Time: safety. We have not changed the final expand the applicability of the NPRM rule regarding this issue. (76 FR 28914, May 19, 2011), or Allow for New Maintenance Procedures otherwise consider similar rulemaking FedEx requested that we revise the Concern for Length of Time To Develop to extend to other airplane models and compliance time in the NPRM (76 FR and Mandate Fix airplanes produced by other 28914, May 19, 2011) to allow time to Two commenters expressed concern manufacturers. While the FAA has not incorporate new maintenance about the length of time it has taken to determined that an unsafe condition procedures to accommodate the develop and mandate a fix for the exists on other airplanes, we are proposed modification. Based on past unsafe condition. considering a number of factors on other experience, FedEx considered the The NTSB, although encouraged by airplanes, including pedal reversals, proposed 48-month compliance time the various actions being considered to pedal sensitivity, and airplane dynamics unrealistic to account for changes in address the unsafe condition, was and fin loads. NTSB Safety maintenance programs. FedEx also concerned about the lack of a definitive

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fix for the rudder system. Since the Airbus suggested that we recharacterize reversals. We have not changed the final exact details of the PTLU fix have not the events as ‘‘excessive rapid rule regarding this issue. yet been available, the NTSB could not alternating and large pilot rudder pedal Request for Information determine the benefit of this system. inputs.’’ Airbus described the reported The NTSB was also concerned about the conditions that support this finding. The NTSB requested information on amount of time spent to make the design Where the NPRM (76 FR 28914, May Airbus’s development of a flight deck change available to operators. 19, 2011) describes the PTLU as one warning light that does not incorporate Geoffrey Barrance also questioned this option under consideration for the any mechanical changes to the rudder timeframe, and asked whether we have modification to the rudder control system. The NTSB is concerned that a new information about the need to system, Airbus suggested that we also warning light alone will not rectify the mandate a modification of the rudder state that the PTLU has no effect on unsafe condition. system. crew awareness that rapid alternating The SRIW warning modification The FAA understands the NTSB and larger rudder inputs addressed in consists of a prominent warning light concern about the lack of definitive section 25.1583 of the Federal Aviation and a loud verbal warning directing the PTLU design information provided with Regulations (14 CFR 25.1583) are always pilot to cease inputs to the rudder. After the NPRM (76 FR 28914, May 19, 2011), inappropriate. Airbus stated that if a reviewing the design, analyses, and and the concern about the amount of flightcrew were to perform such inputs, simulator demonstrations, the FAA has time that has transpired to make a the loads created would be lower for an concluded that these alerts, taken design change available to operators. As airplane fitted with a PTLU than one together, are compelling, timely, and stated in the NPRM, there were no without a PTLU. But the flightcrew will prevent the flightcrew from service instructions available at that would still have the potential to add to continuing the inappropriate rudder time to address the unsafe condition. the loads in the same direction induced inputs prior to exceeding the ultimate However, the FAA determined that on the vertical stabilizer by an design loads that could result in failure taking additional time to develop increasing sideslip. Airbus concluded of the vertical stabilizer. The FAA has service information before beginning the that high loads to the vertical stabilizer determined that the SRIW modification, corrective action notification process will occur anyway if the pilot continues combined with suitable flightcrew was not in the public’s interest. Since to use the inappropriate piloting training programs, provides an the date of the NPRM publication, technique, but a given level of high acceptable mitigation for the unsafe Airbus has developed a design change loads and the associated hazard will be condition. that is a more cost-effective solution reached a few seconds later for an As explained previously, we have than the originally planned PTLU, airplane fitted with a PTLU. changed the final rule to include the which has also received design approval We agree that the requested changes SRIW modification as one approved by the EASA and the FAA. might clarify the background method for complying with this AD. information of the NPRM (76 FR 28914, Request To Clarify Modification Request To Revise Cost Estimate May 19, 2011). The Discussion section, Approval Timeframe however, is not restated in a final rule, Airbus noted that the NPRM (76 FR Geoffrey Barrance acknowledged the so we have not changed the final rule 28914, May 19, 2011) included FAA’s possible reluctance to limit the regarding this issue. estimated costs only for the PTLU corrective action to a single technical installation. Airbus requested that we approach, but questioned why it would Request To Include Additional revise the NPRM to include the take 3 years to mandate installation of Background Information estimated costs to install an alert the PTLU. Francis Gentile requested that we add warning system. UPS asserted that the We have established a compliance a journal article to the AD docket. This NPRM underestimated the costs of the time of 4 years to implement the article indicated the need for design proposed modification, which would required design change, including an improvements to relieve the limited involve upgrading computers and estimated 3-year timeframe for adaptive capability of pilots. installing warning light consoles, developing and approving a We acknowledge the commenter’s switching relays, and associated modification that ensures that parts and request, but the article was not part of interconnect wiring. installation instructions are available. the AD development process and would We agree to revise the cost estimate. The FAA is confident that a serve no purpose in the AD docket. In Cost information for the alert warning modification will be available in a light of potential proprietary issues and system was not available when we timely manner and that the compliance the appropriateness of posting this type issued the NPRM (76 FR 28914, May 19, time, as proposed, will leave adequate of article in the AD docket, we have not 2011). As one of the modifications time for operators to implement the changed the final rule regarding this accepted by the FAA, it should be changes required by this AD. We have issue. included. We have revised the Costs of not changed the final rule regarding this Compliance section accordingly in this Request To Provide Information on issue. final rule. Evaluation of Rudder Pedal Sensitivity Request To Clarify Background in ALPA requested an evaluation of Request To Change Air Transport NPRM (76 FR 28914, May 19, 2011) rudder pedal sensitivity and means to Association (ATA) Code Based on its request for an alternative prevent inadvertent over control. Airbus requested that we revise solution to the unsafe condition, Airbus The FAA has already tasked the paragraph (d) of the NPRM (76 FR requested changes to the Discussion ARAC to consider general rulemaking in 28914, May 19, 2011) to add ATA Code section of the NPRM (76 FR 28914, May 14 CFR part 25 to address pedal 31, Instruments, to reflect Airbus’s 19, 2011). sensitivity as well as several other proposal to install a crew warning as Where the NPRM (76 FR 28914, May considerations to ensure that pilot- one way to comply with the NPRM. 19, 2011) referred to events of commanded pedal reversals are safe or We agree with the request and ‘‘excessive rudder pedal inputs’’ that precluded, or that the system design rationale. We have changed paragraph resulted in high vertical stabilizer loads, reduces the likelihood of pedal (d) in this final rule accordingly.

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Questions About Safety changed the final rule regarding this Costs of Compliance Recommendations (SRs) issue. We estimate that this AD will affect Mr. Barrance asked whether the Conclusion 215 airplanes of U.S. registry. NPRM (76 FR 28914, May 19, 2011) addressed NTSB SRs A–04–56 and A– We reviewed the relevant data, The unsafe condition may be 04–57, and whether failure to refer to SR considered the comments received, and addressed by installing a PTLU or alert A–04–58 was an omission. determined that air safety and the warning system, although these may not An FAA ARAC is considering general public interest require adopting the AD be the only acceptable methods. The rulemaking to address rudder pedal with the changes described previously. following table provides the estimated sensitivity, including factors beyond We also determined that these changes costs for U.S. operators to comply with those specified in this AD. This AD is will not increase the economic burden this AD, based on preliminary in response to SRs A–04–058, A–04– on any operator or increase the scope of information provided by the 044, and A–04–063. We have not the AD. manufacturer.

ESTIMATED COSTS

Average labor Cost per Installation Work hours rate per hour Parts product

PTLU ...... 100 $85 $190,000 $198,500 Alert warning system for products with a flight warning computer standard developed from year 2000 and onwards ...... 32 85 70,000 72,720 Alert warning system for remaining airplanes ...... 32 85 105,000 107,720

Authority for This Rulemaking (4) Will not have a significant –204, –221, –222, –304, –322, –324, and –325 airplanes; certificated in any category. Title 49 of the United States Code economic impact, positive or negative, specifies the FAA’s authority to issue on a substantial number of small entities (d) Subject rules on aviation safety. Subtitle I, under the criteria of the Regulatory Air Transport Association (ATA) of section 106, describes the authority of Flexibility Act. America Code 27, Flight controls; and 31, the FAA Administrator. Subtitle VII: List of Subjects in 14 CFR Part 39 Instruments. Aviation Programs, describes in more (e) Unsafe Condition Air transportation, Aircraft, Aviation detail the scope of the Agency’s This AD was prompted by events of authority. safety, Incorporation by reference, Safety. excessive alternating rudder pedal inputs and We are issuing this rulemaking under consequent loads on the vertical stabilizer the authority described in Subtitle VII, Adoption of the Amendment that exceed ultimate design loads. Such Part A, Subpart III, Section 44701: events could lead to failure of the vertical ‘‘General requirements.’’ Under that Accordingly, under the authority stabilizer and consequent reduced section, Congress charges the FAA with delegated to me by the Administrator, controllability of the airplane. promoting safe flight of civil aircraft in the FAA amends 14 CFR part 39 as (f) Compliance follows: air commerce by prescribing regulations You are responsible for having the actions for practices, methods, and procedures PART 39—AIRWORTHINESS required by this AD performed within the the Administrator finds necessary for DIRECTIVES compliance times specified, unless the safety in air commerce. This regulation actions have already been done. is within the scope of that authority ■ 1. The authority citation for part 39 (g) Modification because it addresses an unsafe condition continues to read as follows: Within 48 months after the effective date that is likely to exist or develop on Authority: 49 U.S.C. 106(g), 40113, 44701. of this AD, do the actions specified in either products identified in this rulemaking paragraph (g)(1) or (g)(2) of this AD to action. address the unsafe condition identified in § 39.13 [Amended] paragraph (e) of this AD. Regulatory Findings ■ 2. The FAA amends § 39.13 by adding (1) Incorporate a design change to the This AD will not have federalism the following new airworthiness rudder control system and/or other systems, in accordance with a method approved by implications under Executive Order directive (AD): 13132. This AD will not have a the Manager, International Branch, ANM– substantial direct effect on the States, on 2012–21–15 Airbus: Amendment 39–17231; 116, Transport Airplane Directorate, FAA. Docket No. FAA–2011–0518; Directorate (2) Install a stop rudder inputs warning the relationship between the national Identifier 2010–NM–150–AD. (SRIW) modification by doing the applicable government and the States, or on the actions specified in paragraph (g)(2)(i) or distribution of power and (a) Effective Date (g)(2)(ii) of this AD, as applicable. responsibilities among the various This AD is effective December 14, 2012. (i) For Model A300–600 series airplanes: Do the applicable actions specified in levels of government. (b) Affected ADs For the reasons discussed above, I paragraphs (g)(2)(i)(A) and (g)(2)(i)(B) of this certify that this AD: None. AD. (1) Is not a ‘‘significant regulatory (A) Install a SRIW device, in accordance (c) Applicability with the Accomplishment Instructions of action’’ under Executive Order 12866, This AD applies to all Airbus Model A300 Airbus Service Bulletin A300–22–6054, (2) Is not a ‘‘significant rule’’ under B4–601, B4–603, B4–620, and B4–622 including Appendix 01, dated June 20, 2012. DOT Regulatory Policies and Procedures airplanes; Model A300 B4–605R and B4– Before or concurrently with the SRIW (44 FR 11034, February 26, 1979), 622R airplanes; Model A300 F4–605R and installation, do the actions specified in (3) Will not affect intrastate aviation F4–622R airplanes; Model A300 C4–605R paragraphs (g)(2)(i)(A)(1) and (g)(2)(i)(A)(2) of in Alaska, and Variant F airplanes; and Model A310–203, this AD.

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(1) Upgrade the flight control computer (iii) Airbus Service Bulletin A300–22– Issued in Renton, Washington, on October (FCC) to introduce the SRIW logic, in 6054, including Appendix 01, dated June 20, 12, 2012. accordance with the Accomplishment 2012. Ali Bahrami, Instructions of Airbus Service Bulletin A300– (iv) Airbus Service Bulletin A300–22– Manager, Transport Airplane Directorate, 22–6056, dated April 25, 2012. 6056, dated April 25, 2012. Aircraft Certification Service. (2) Upgrade the flight warning computer (v) Airbus Service Bulletin A300–31–6140, [FR Doc. 2012–26963 Filed 11–8–12; 8:45 am] (FWC) to introduce the SRIW aural dated May 4, 2012. BILLING CODE 4910–13–P capability, in accordance with the (vi) Airbus Service Bulletin A310–22– Accomplishment Instructions of Airbus 2063, including Appendix 01, dated June 20, Service Bulletin A300–31–6140, dated May 2012. 4, 2012. DEPARTMENT OF TRANSPORTATION (vii) Airbus Service Bulletin A310–22– (B) Activate the SRIW device, in accordance with the Accomplishment 2065, dated April 25, 2012. Federal Aviation Administration Instructions of Airbus Mandatory Service (viii) Airbus Service Bulletin A310–31– Bulletin A300–22–6055, Revision 01, 2144, dated May 4, 2012. 14 CFR Part 39 including Appendix 01, dated May 31, 2012. (2) For more information about this AD, (ii) For Model A310 series airplanes: Do contact Dan Rodina, Aerospace Engineer, [Docket No. FAA–2012–0502; Directorate the actions specified in paragraphs International Branch, ANM–116, Transport Identifier 2010–SW–097–AD; Amendment (g)(2)(ii)(A) and (g)(2)(ii)(B) of this AD. Airplane Directorate, FAA, 1601 Lind 39–17242; AD 2012–22–06] (A) Install a SRIW device, in accordance Avenue SW., Renton, Washington 98057– RIN 2120–AA64 with the Accomplishment Instructions of 3356; telephone 425–227–2125; fax 425–227– Airbus Service Bulletin A310–22–2063, 1149. Airworthiness Directives; Aeronautical including Appendix 01, dated June 20, 2012. (j) Material Incorporated by Reference Accessories, Inc., High Landing Gear Before or concurrently with the SRIW Forward Crosstube Assembly installation, do the actions specified in (1) The Director of the Federal Register paragraphs (g)(2)(ii)(A)(1) and (g)(2)(ii)(A)(2) approved the incorporation by reference AGENCY: Federal Aviation of this AD. (IBR) of the service information listed in this Administration (FAA), DOT. (1) Upgrade the FCC to introduce the SRIW paragraph under 5 U.S.C. 552(a) and 1 CFR ACTION: Final rule. logic, in accordance with the part 51. Accomplishment Instructions of Airbus (2) You must use this service information SUMMARY: We are adopting a new Service Bulletin A310–22–2065, dated April as applicable to do the actions required by airworthiness directive (AD) for 25, 2012. this AD, unless the AD specifies otherwise. Aeronautical Accessories, Inc. (AAI) (2) Upgrade the FWC to introduce the (i) Airbus Mandatory Service Bulletin SRIW aural capability, in accordance with high landing gear forward crosstube the Accomplishment Instructions of Airbus A300–22–6055, Revision 01, including assemblies (crosstubes) installed on Service Bulletin A310–31–2144, dated May Appendix 01, dated May 31, 2012. Agusta S.p.A. (Agusta) Model AB412 4, 2012. (ii) Airbus Mandatory Service Bulletin and AB412EP; and Bell Helicopter (B) Activate the SRIW device, in A310–22–2064, Revision 01, including Textron, Inc. (Bell) Model 205A, 205A– accordance with the Accomplishment Appendix 01, dated May 31, 2012. 1, 205B, 212, 412, 412CF, and 412EP Instructions of Airbus Mandatory Service (iii) Airbus Service Bulletin A300–22– helicopters during production or based Bulletin A310–22–2064, Revision 01, 6054, including Appendix 01, dated June 20, on a supplemental type certificate including Appendix 01, dated May 31, 2012. 2012. (STC). This AD requires counting and (iv) Airbus Service Bulletin A300–22– (h) Alternative Methods of Compliance recording the total number of landings 6056, dated April 25, 2012. (AMOCs) for the crosstubes, and inspecting the (v) Airbus Service Bulletin A300–31–6140, crosstubes and replacing them if a crack (1) The Manager, International Branch, dated May 4, 2012. or other damage exists. This AD was ANM–116, Transport Airplane Directorate, (vi) Airbus Service Bulletin A310–22– FAA, has the authority to approve AMOCs 2063, including Appendix 01, dated June 20, prompted by two reports from the field for this AD, if requested using the procedures 2012. of failed crosstubes. The actions are found in 14 CFR 39.19. In accordance with (vii) Airbus Service Bulletin A310–22– intended to prevent failure of a 14 CFR 39.19, send your request to your crosstube, collapse of the landing gear, principal inspector or local Flight Standards 2065, dated April 25, 2012. (viii) Airbus Service Bulletin A310–31– and subsequent loss of control of the District Office, as appropriate. If sending helicopter. information directly to the Manager, ANM– 2144, dated May 4, 2012. 116, send it to the attention of the person (3) For the service information identified in DATES: This AD is effective December identified in the Related Information section this AD, contact Airbus SAS–EAW 14, 2012. of this AD. (Airworthiness Office), 1 Rond Point Maurice The Director of the Federal Register (2) Before using any approved AMOC, Bellonte, 31707 Blagnac Cedex, France; approved the incorporation by reference notify your appropriate principal inspector, telephone +33 5 61 93 36 96; fax +33 5 61 of certain documents listed in this AD or lacking a principal inspector, the manager 93 44 51; email account.airworth- as of December 14, 2012. of the local flight standards district office/ [email protected]; Internet http:// ADDRESSES: For service information certificate holding district office. www.airbus.com. identified in this AD, contact (i) Related Information (4) You may view this service information at the FAA, Transport Airplane Directorate, Aeronautical Accessories, Inc., P.O. Box (1) For related information, refer to MCAI 1601 Lind Avenue SW., Renton, Washington. 3689, Bristol, TN 37625–3689, European Aviation Safety Agency For information on the availability of this telephone (423) 538–5151 or (800) 251– Airworthiness Directive 2012–0088, dated material at the FAA, call 425–227–1221. 7094, fax (423) 538–8469, or at http:// June 25, 2012, and the service bulletins (5) You may view this service information www.aero-access.com. You may review identified in paragraphs (i)(1)(i) through a copy of the referenced service (i)(1)(viii) of this AD, for related information. that is incorporated by reference at the (i) Airbus Mandatory Service Bulletin National Archives and Records information at the FAA, Office of the A300–22–6055, Revision 01, including Administration (NARA). For information on Regional Counsel, Southwest Region, Appendix 01, dated May 31, 2012. the availability of this material at NARA, call 2601 Meacham Blvd., Room 663, Fort (ii) Airbus Mandatory Service Bulletin 202–741–6030, or go to: http:// Worth Texas 76137. A310–22–2064, Revision 01, including www.archives.gov/federal-register/cfr/ibr- Examining the AD Docket: You may Appendix 01, dated May 31, 2012. locations.html. examine the AD docket on the Internet

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at http://www.regulations.gov or in adopting the AD requirements as promoting safe flight of civil aircraft in person at the Docket Operations Office proposed. air commerce by prescribing regulations between 9 a.m. and 5 p.m., Monday for practices, methods, and procedures Related Service Information through Friday, except Federal holidays. the Administrator finds necessary for The AD docket contains this AD, any We reviewed the AAI ASB, which safety in air commerce. This regulation incorporated-by-reference service specifies establishing a takeoff/landing is within the scope of that authority information, the economic evaluation, history, recurrent visual and fluorescent because it addresses an unsafe condition any comments received, and other penetrant inspections of the crosstubes, that is likely to exist or develop on information. The street address for the and dimensional inspections of the skid products identified in this rulemaking Docket Operations Office (phone: 800– gear. We have also reviewed AAI action. 647–5527) is U.S. Department of Instructions for Continued Regulatory Findings Transportation, Docket Operations Airworthiness (ICA) for Crosstubes, Office, M–30, West Building Ground Report No. AA–01136, Revision K, This AD will not have federalism Floor, Room W12–140, 1200 New Jersey dated February 15, 2012, which implications under Executive Order Avenue SE., Washington, DC 20590. contains the information necessary for 13132. This AD will not have a FOR FURTHER INFORMATION CONTACT: inspection and maintenance of each substantial direct effect on the States, on Michael Kohner, Aviation Safety crosstube installed on the Agusta and the relationship between the national Engineer, Rotorcraft Certification Office, Bell helicopters. government and the States, or on the distribution of power and Rotorcraft Directorate, FAA, 2601 Costs of Compliance Meacham Blvd., Fort Worth, TX 76137; responsibilities among the various telephone (817) 222–5170; email 7-avs- We estimate that this AD will affect levels of government. [email protected]. 115 helicopters of U.S. Registry and that For the reasons discussed above, I certify that this AD: SUPPLEMENTARY INFORMATION: operators will incur the following costs to comply with this AD: (1) Is not a ‘‘significant regulatory Discussion • Creating a historical record and action’’ under Executive Order 12866; On May 11, 2012, at 77 FR 27663, the determining the number of landings will (2) Is not a ‘‘significant rule’’ under Federal Register published our notice of require a half work hour at an average DOT Regulatory Policies and Procedures proposed rulemaking (NPRM), which labor rate of $85 per hour for a cost per (44 FR 11034, February 26, 1979); (3) Will not affect intrastate aviation proposed to amend 14 CFR part 39 to helicopter of about $42 and a cost to the in Alaska to the extent that it justifies include an AD that would apply to AAI U.S. operator fleet of $4,830 per making a regulatory distinction; and crosstubes installed on Agusta Model inspection cycle. • (4) Will not have a significant AB412 and AB412EP, and Bell Model Preparing and inspecting the economic impact, positive or negative, 205A, 205A–1, 205B, 212, 412, 412CF, crosstube will require 8.5 work hours at on a substantial number of small entities and 412EP helicopters during an average labor rate of $85 per hour for under the criteria of the Regulatory production or based on an STC. That a cost per helicopter of about $722 and a cost to the U.S. operator fleet of Flexibility Act. NPRM proposed to require creating a We prepared an economic evaluation component history card or equivalent $83,030 per inspection cycle. • Performing the dimensional of the estimated costs to comply with record and counting and recording the this AD and placed it in the AD docket. total number of landings for the inspection of the skid gear will require crosstubes. It also proposed to require 1 work hour at an average labor rate of List of Subjects in 14 CFR Part 39 $85 per hour for a cost per helicopter of inspecting the crosstubes and replacing Air transportation, Aircraft, Aviation $85 and a cost to the U.S. operator fleet them if a crack or other damage exists. safety, Incorporation by reference, The proposed requirements were of $9,775 per inspection cycle. • Safety. intended to prevent failure of a Fluorescent penetrant inspecting crosstube, collapse of the landing gear, the crosstube will require 24 work hours Adoption of the Amendment and subsequent loss of control of the at an average labor rate of $85 per hour Accordingly, under the authority helicopter. for a cost per helicopter of $2,040 and delegated to me by the Administrator, The NPRM was prompted by two a cost to the U.S. operator fleet of the FAA amends 14 CFR part 39 as reports from the field of crosstube $234,600 per inspection cycle. follows: failures. AAI issued Alert Service • If required, replacing a crosstube Bulletin AA–08055, Revision B, dated with an airworthy crosstube will require PART 39—AIRWORTHINESS August 12, 2009 (ASB) to provide 10 work hours at an average labor rate DIRECTIVES procedures for repetitively inspecting of $85, required parts will cost $9,315, ■ the high forward crosstubes to detect for a cost per helicopter of $10,165. 1. The authority citation for part 39 continues to read as follows: this condition. Authority for This Rulemaking Authority: 49 U.S.C. 106(g), 40113, 44701. Comments Title 49 of the United States Code We gave the public the opportunity to specifies the FAA’s authority to issue § 39.13 [Amended] rules on aviation safety. Subtitle I, participate in developing this AD, but ■ section 106, describes the authority of 2. The FAA amends § 39.13 by adding we received no comments on the NPRM the following new airworthiness (77 FR 27663, May 11, 2012). the FAA Administrator. Subtitle VII: Aviation Programs, describes in more directive (AD): FAA’s Determination detail the scope of the Agency’s 2012–22–06 Aeronautical Accessories, Inc. We have reviewed the relevant authority. (AAI): Amendment 39–17242; Docket information and determined that an We are issuing this rulemaking under No. FAA–2012–0502; Directorate unsafe condition exists and is likely to the authority described in Subtitle VII, Identifier 2010–SW–097–AD. exist or develop on other products of Part A, Subpart III, Section 44701: (a) Applicability these same type designs and that air ‘‘General requirements.’’ Under that This AD applies to high landing gear safety and the public interest require section, Congress charges the FAA with forward crosstube assembly (crosstube), part

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number (P/N) 212–321–103, installed on replace the crosstube with an airworthy (g) Subject Agusta S.p.A. Model AB412 and AB412EP crosstube. Joint Aircraft Service Component (JASC) and Bell Helicopter Textron, Inc. Model (4) Within 30 days after the effective date Code: 3213: Main Landing Gear Strut/Axle/ 205A, 205A–1, 205B, 212, 412, 412CF, and of this AD or before reaching a total of 10,000 Truck. 412EP helicopters, certificated in any landings on any crosstube, whichever occurs category. later, and thereafter at intervals not to exceed (h) Material Incorporated by Reference (b) Unsafe Condition 2,500 landings or 12 months, whichever (1) The Director of the Federal Register occurs first, determine the horizontal approved the incorporation by reference This AD defines the unsafe condition as deflection of the crosstube from the (IBR) of the service information listed in this failure of the landing gear crosstube, which paragraph under 5 U.S.C. 552(a) and 1 CFR could result in collapse of the landing gear centerline of the helicopter (BL 0.0) to the outside of the skid tubes by following the part 51. and subsequent loss of control of the (2) You must use this service information helicopter. Accomplishment Instructions, Part D, paragraphs 1. and 2., of the ASB. If the as applicable to do the actions required by this AD, unless the AD specifies otherwise. (c) Effective Date crosstube measures outside any of the limits (i) Aeronautical Accessories Inc. Alert This AD becomes effective December 14, depicted in Figure 2 of the ASB, before Service Bulletin No. AA–08055, Revision B, 2012. further flight, replace the crosstube with an dated August 12, 2009. airworthy crosstube. (d) Compliance (ii) Aeronautical Accessories Inc. (5) Within 3 months after the effective date Instructions for Continued Airworthiness for You are responsible for performing each of this AD or before reaching a total of 12,500 action required by this AD within the Crosstubes, Report No. AA–01136, Revision landings on any crosstube, whichever occurs K, dated February 15, 2012. specified compliance time unless it has later, and thereafter at intervals not to exceed already been accomplished prior to that time. (3) For service information identified in 5,000 landings: this AD, contact Aeronautical Accessories, (e) Required Actions (i) Remove and disassemble the landing Inc., P.O. Box 3689, Bristol, TN 37625–3689, (1) Within 50 hours time-in-service (TIS) gear assembly and crosstube to prepare for a telephone (423) 538–5151 or (800) 251–7094, after the effective date of this AD: fluorescent penetrant inspection (FPI) by fax (423) 538–8469, or at http://www.aero- (i) Create a component history card or following the Accomplishment Instructions, access.com. equivalent record for the crosstube by Part E.1, paragraphs 1. through 6., of the (4) You may view this service information following the Accomplishment Instructions, ASB. at the FAA, Office of the Regional Counsel, Part A, paragraph 1., of AAI Alert Service (ii) Clean and prepare the crosstube by Southwest Region, 2601 Meacham Blvd., Bulletin No. AA–08055, Revision B, dated removing the sealant and paint as described Room 663, Fort Worth, Texas 76137. August 12, 2009 (ASB). in the Accomplishment Instructions, Part E.2, (5) You may also view this service (ii) Determine and record on the paragraphs 1. through 3. and Figure 3, of the information at the National Archives and component history card or equivalent record ASB. Records Administration (NARA). For the total number of landings for the (iii) Perform an FPI of the crosstube in the information on the availability of this crosstube. If the landing information is areas depicted in Figure 3 of the ASB for a material at NARA, call (202) 741–6030, or go unavailable, estimate the number by crack, any corrosion, a nick, scratch, dent, or to: http://www.archives.gov/federal-register/ cfr/ibr-locations.html. multiplying the airframe hours TIS by 10. any other damage by following the Continue to count and record the number of Accomplishment Instructions, Part E.3, Issued in Fort Worth, Texas, on October 24, landings for the crosstube. For the purposes paragraph 1., of the ASB. If there is a crack, 2012. of this AD, a landing would be counted anytime the helicopter lifts off into the air before further flight, replace the crosstube Lance T. Gant, and then lands again with any further with an airworthy crosstube. Acting Directorate Manager, Rotorcraft reduction of the collective after the landing (iv) If there is any corrosion or a nick, Directorate, Aircraft Certification Service. gear touches the ground. scratch, dent, or any other damage, before [FR Doc. 2012–26901 Filed 11–8–12; 8:45 am] further flight, repair the crosstube to an (2) Within 50 hours TIS after the effective BILLING CODE 4910–13–P date of this AD or before reaching a total of airworthy configuration if the damage is 7,500 landings on any crosstube, whichever within the maximum repair damage limits or replace the crosstube with an airworthy occurs later: DEPARTMENT OF TRANSPORTATION (i) Prepare the crosstube inspection areas crosstube. Chapter 3.5 Repair, Table 1. and as described in the Accomplishment Figure 3 of the AAI Instructions for Federal Aviation Administration Instructions, Part B, paragraphs 1. through 5. Continued Airworthiness for Crosstubes, and Figure 1, of the ASB. Report No. AA–01136, Revision K, dated (ii) Using a 10X or higher power February 15, 2012, contains the maximum 14 CFR Part 39 magnifying glass and a bright light, visually repair damage limits and repair procedures. [Docket No. FAA–2012–0428; Directorate inspect the prepared areas of the crosstube Identifier 2011–NM–078–AD; Amendment (f) Alternative Methods of Compliance for a crack. If there is a crack, before further 39–17248; AD 2012–22–12] flight, replace the crosstube with an (AMOCs) airworthy crosstube. (1) The Manager, Rotorcraft Certification RIN 2120–AA64 (iii) If there is no crack, following the Office, FAA, may approve AMOCs for this inspection, prime and paint the inspection AD. Send your proposal to: Michael Kohner, Airworthiness Directives; Airbus areas by following the Accomplishment Aviation Safety Engineer, Rotorcraft Airplanes Instructions, Part B, paragraphs 7. and 8., of Certification Office, Rotorcraft Directorate, the ASB. If there is any corrosion or other AGENCY: Federal Aviation FAA, 2601 Meacham Blvd., Fort Worth, TX damage, perform the replacement or repair Administration (FAA), Department of 76137; telephone (817) 222–5170; email 7- required in paragraph (e)(5)(iv) of this AD Transportation (DOT). before priming and painting the inspection [email protected]. ACTION: Final rule. areas. (2) For operations conducted under a 14 CFR part 119 operating certificate or under (3) Thereafter, at intervals not to exceed SUMMARY: 14 CFR part 91, subpart K, we suggest that We are adopting a new 200 landings, clean the crosstube inspection airworthiness directive (AD) for all areas by following the Accomplishment you notify your principal inspector, or Instructions, Part C, paragraph 1., of the ASB. lacking a principal inspector, the manager of Airbus Model A330–243, –243F, –341, Using a 10X or higher power magnifying the local flight standards district office or –342, and –343 airplanes. This AD was glass and a bright light, visually inspect the certificate holding district office before prompted by reports of cracking of air clear-coated areas of the crosstube for a crack. operating any aircraft complying with this intake cowls on Rolls-Royce Trent If there is a crack, before further flight, AD through an AMOC. engines, worn and detached attachment

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links, and fractured thermal anti-ice applicable corrective action(s). These unnecessarily complicated management (TAI) piccolo tubes. This AD requires inspections include internal inspection of plan by an operator. US Airways inspecting piccolo tubes, piccolo tube Piccolo tube, detailed inspection of Piccolo reasoned that the serviceability of the mount links, the aft side of the forward tube mount links, [boroscope] inspection of inlet cowl being inspected should be aft side of forward bulkhead and outer bulkhead, and outer boundary angles boundary angle [for cracks, fractures, and determined independently of the inlet (OBA) for cracks, fractures, and broken broken links]. cowl installed on the other engine, and links, and corrective actions if that Table 3 ‘‘Detailed Inspection of the necessary. We are issuing this AD to We are issuing this AD to prevent Broken Piccolo Tubes Links’’ of prevent degraded structural integrity of degraded structural integrity of the Paragraph 1.E., ‘‘Compliance,’’ of Airbus the engine nose cowl in case of forward engine nose cowl in case of forward Mandatory Service Bulletin A330–71– bulkhead damage in conjunction with a bulkhead damage in conjunction with a 3025, dated January 10, 2011, contains broken piccolo tube, and damage to the broken piccolo tube and damage to the 20 different scenarios related to the engine due to operation in icing engine due to operation in icing number of broken piccolo tube links in conditions with reduced TAI conditions with reduced TAI both the left and right inlet cowls and performance. performance. The corrective action is flight cycles achieved on each inlet replacing the affected engine air intake cowl. US Airways stated that the left DATES: This AD becomes effective cowl with a new or serviceable cowl. December 14, 2012. and right engines and nacelles are You may obtain further information by completely separate and designed to The Director of the Federal Register examining the MCAI in the AD docket. approved the incorporation by reference individually provide continued of certain publications listed in this AD Comments propulsion to the airplane in the event of failure of one engine; and that this is as of December 14, 2012. We gave the public the opportunity to the basis of the FAA extended participate in developing this AD. We ADDRESSES: You may examine the AD operations (ETOPS) rules. considered the comments received. docket on the Internet at http:// We disagree with changing the www.regulations.gov or in person at the Request To Delete Completion of piccolo tube link inspection U.S. Department of Transportation, Reporting Form requirements, and allowing one piccolo Docket Operations, M–30, West US Airways requested that we delete tube link broken on each inlet cowl. The Building Ground Floor, Room W12–140, criteria and corrective actions specified 1200 New Jersey Avenue SE., the requirement to complete Appendix 01 of Airbus Mandatory Service Bulletin in Airbus Mandatory Service Bulletin Washington, DC. A330–71–3025, dated January 10, 2011, FOR FURTHER INFORMATION CONTACT: A330–71–3025, dated January 10, 2011, which is the form for reporting represent the conditions for the safe Vladimir Ulyanov, Aerospace Engineer, operation of the airplane. Only one International Branch, ANM–116, inspection results to Airbus. US Airways stated that accomplishing this piccolo tube link broken on the airplane Transport Airplane Directorate, FAA, is allowed. The commenter did not 1601 Lind Avenue SW., Renton, WA reporting is burdensome and does not improve the safety aspects of the inlet provide sufficient data to substantiate 98057–3356; telephone (425) 227–1138; that its request would provide an fax (425) 227–1149. cowl inspections. We agree because reporting is acceptable level of safety. Once we issue SUPPLEMENTARY INFORMATION: voluntary. Airbus has concurred that this AD, any person may request approval of an alternate methods of Discussion EASA AD 2011–0062, dated April 4, 2011, does not require reporting of the compliance (AMOC) under the We issued a notice of proposed inspection findings and that it is provisions of paragraph (k) of this AD. rulemaking (NPRM) to amend 14 CFR Airbus’s intent that reporting should be We have not changed the AD in this part 39 to include an AD that would done on a voluntary basis. We have regard. apply to the specified products. That changed the final rule throughout to NPRM was published in the Federal Request To Change OBA and Forward exclude Appendix 01 when referring to Bulkhead Inspection Criteria Register on May 8, 2012 (77 FR 26998). Airbus Mandatory Service Bulletin That NPRM proposed to correct an A330–71–3025, dated January 10, 2011. US Airways recommended a change unsafe condition for the specified in the OBA and forward bulkhead products. The MCAI states: Request To Change Piccolo Tube Link inspection criteria, as follows. During shop visit, several primary Inspection • Cracks up to 9 inches in length on assembly structures of A330 aeroplanes Trent US Airways requested that the piccolo the OBA would be acceptable. 700 [engine] air intake cowl have been found tube link inspection be completely • Cracks up to 2 inches in length on with cracks in the forward bulkhead web, independent for each inlet cowl, and the forward bulkhead would be web stiffeners and outer boundary angles. that a conservative approach could be acceptable. Several attachment links have been found • Re-inspection of the OBA and severely worn, and some had become incorporated in the NPRM (77 FR detached. In 2 cases, the Thermal Anti Ice 26998, May 8, 2012) to allow only one forward bulkhead would be required at (TAI) Piccolo tube was found fractured. broken piccolo tube link on an inlet subsequent intervals not to exceed 2,500 Investigations are still ongoing to determine cowl if the cowl remains in service on flight cycles. the root cause(s). an airplane. US Airways stated that • Replace the inlet cowl for any OBA If not detected and corrected, a broken more than one broken piccolo tube link crack of 22 inches or greater or any Piccolo tube in conjunction with forward would mandate removal of the cowl forward bulkhead crack of 13 inches or bulkhead damage could ultimately lead to in prior to further flight. US Airways greater, would be required prior to flight detachment of the outer barrel, which explained that the inspection results tie further flight. would constitute an unsafe condition. • For the reasons described above, this the serviceability of cowl being Replace the inlet cowl for an OBA [European Aviation Safety Agency (EASA)] inspected to the condition of the inlet crack greater than 15 inches, but less AD requires to perform inspections of RR cowl installed on the other engine of the than 22 inches, or any forward bulkhead [Rolls-Royce] Trent 700 [engine] nose cowls airplane. US Airways asserted that this crack greater than 9 inches, but less than and, depending on findings, to do the will require a difficult and 13 inches, within 100 flight cycles.

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We disagree because Airbus paragraph (h)(2) of the NPRM (77 FR except for minor editorial changes. We Mandatory Service Bulletin A330–71– 26998, May 8, 2012). have determined that these changes: 3025, dated January 10, 2011, which US Airways requested that we clarify • Are consistent with the intent that references Rolls-Royce Service Bulletin the instructions in paragraph (h)(3) of was proposed in the NPRM (77 FR RB.211–71–AG416, dated September 3, the NPRM (77 FR 26998, May 8, 2012) 26998, May 8, 2012) for correcting the 2010, provides the inspection criteria by revising ‘‘* * * and the opposite unsafe condition; and and allowable conditions for the safe intake cowl of the same engine has • Do not add any additional burden operation of the airplane. The * * *,’’ to state ‘‘* * * and the intake upon the public than was already commenter did not present sufficient cowl of the opposite engine has * * *.’’ proposed in the NPRM (77 FR 26998, data to substantiate that the crack We agree to clarify paragraphs (h)(2) May 8, 2012). lengths in its first and second and (h)(3) of this AD. We changed the Costs of Compliance recommendations would provide an word ‘‘engine’’ to ‘‘airplane’’ in acceptable level of safety. Actions paragraphs (h)(2) and (h)(3) of the AD, Based on the service information, we suggested by the commenter in its third, since each engine has one inlet cowl. estimate that this AD affects about 14 fourth, and fifth recommendations are products of U.S. registry. We also Request To Change Unsafe Condition already reflected in paragraphs (i)(1)(ii), estimate that it takes about 10 work- Statement (i)(2)(i), and (i)(2)(ii) of this AD. hours per engine to comply with the However, operators may request Airbus requested that we remove the basic requirements of this AD. The approval of an AMOC under the information that a broken piccolo tube average labor rate is $85 per work-hour. provisions of paragraph (k) of this AD if could lead to in-flight damage of the Based on these figures, we estimate the sufficient data are submitted to engine and reduced TAI performance cost of the AD on U.S. operators to be substantiate that the change would from the unsafe condition statement in $11,900 per engine, or $850 per engine. provide a acceptable level of safety. We the NPRM (77 FR 26998, May 8, 2012). In addition, we estimate that any have not changed the AD in this regard. We agree with the commenter’s necessary follow-on actions would take Request To Change Engine Inlet Cowl requested wording change of the unsafe about 16 work-hours per engine for a Inspection condition statement in this AD. In cost of $1,360 per engine. We have US Airways recommended a simpler addition, we have revised the unsafe received no definitive data that would re-inspection management plan of condition statement in this AD to match enable us to provide material cost inspecting any engine inlet cowl that the unsafe condition statement defined estimates for the on-condition actions has achieved more than 5,000 flight in Airbus Mandatory Service Bulletin specified in this AD. We have no way cycles since new at repeat intervals not A330–71–3025, dated January 10, 2011. of determining the number of products to exceed 2,500 flight cycles. US We have changed the Summary and that might need these actions. Discussion sections, and paragraph (e) Airways stated that the engine inlet Authority for This Rulemaking cowl inspection should follow Airbus of the AD. Title 49 of the United States Code Mandatory Service Bulletin A330–71– Request To Change Repetitive specifies the FAA’s authority to issue 3025, dated January 10, 2011; and Rolls- Inspection Interval Royce Service Bulletin RB.211–71– rules on aviation safety. Subtitle I, AG416, dated September 3, 2010; Airbus requested that we lower the section 106, describes the authority of regarding the inspection schedule of the repetitive inspection interval for the the FAA Administrator. ‘‘Subtitle VII: piccolo tube, the piccolo tube links, the OBA and forward bulkhead inspections Aviation Programs,’’ describes in more OBA, and the forward bulkhead. from 450 flight cycles to 250 flight detail the scope of the Agency’s We disagree because Airbus cycles, and from 400 flight cycles to 200 authority. Mandatory Service Bulletin A330–71– flight cycles respectively. The We are issuing this rulemaking under 3025, dated January 10, 2011, which commenter stated that these lower the authority described in ‘‘Subtitle VII, references Rolls-Royce Service Bulletin inspection intervals will be introduced Part A, Subpart III, Section 44701: RB.211–71–AG416, dated September 3, in the forthcoming revisions of the General requirements.’’ Under that 2010, specifies the repetitive inspection Airbus and Rolls-Royce service section, Congress charges the FAA with intervals for the safe operation of the information. promoting safe flight of civil aircraft in airplane, which depend on the crack We disagree to change the repetitive air commerce by prescribing regulations size. If the crack is within allowable inspection intervals in this AD. We have for practices, methods, and procedures limits, the inspection interval may be determined that the compliance times the Administrator finds necessary for greater or less than 2,500 flight cycles as required by this AD adequately address safety in air commerce. This regulation recommended by the commenter. the identified unsafe condition. is within the scope of that authority Insufficient justification was submitted However, if additional data are because it addresses an unsafe condition to substantiate a 2,500-flight-cycle presented that would justify a shorter that is likely to exist or develop on inspection interval. However, under the compliance time, we might consider products identified in this rulemaking provisions of paragraph (k) of this AD further rulemaking on this issue. New action. revisions of the service information we will consider requests for an AMOC Regulatory Findings if sufficient data is submitted to justify referenced in this AD have not been an extended inspection interval for released. We have not changed the AD We determined that this AD will not certain limits. We have not changed the in this regard. have federalism implications under Executive Order 13132. This AD will AD in this regard. Conclusion not have a substantial direct effect on Request To Change Wording in We reviewed the available data, the States, on the relationship between Paragraphs (h)(2) and (h)(3) of the including the comments received, and the national government and the States, NPRM (77 FR 26998, May 8, 2012) determined that air safety and the or on the distribution of power and Airbus requested that we change the public interest require adopting the AD responsibilities among the various word ‘‘engine’’ to ‘‘aircraft’’ in with the changes described previously, levels of government.

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For the reasons discussed above, I certificated in any category, all serial Appendices 01 and 02, dated January 10, certify that this AD: numbers. 2011. (2) If three or fewer broken piccolo tube 1. Is not a ‘‘significant regulatory (d) Subject action’’ under Executive Order 12866; links are found, and the opposite engine air Air Transport Association (ATA) of intake cowl of the same airplane has 2. Is not a ‘‘significant rule’’ under the America Code 71, Powerplant. accumulated 5,000 flight cycles or less since DOT Regulatory Policies and Procedures the engine air intake cowl was first installed (44 FR 11034, February 26, 1979); (e) Reason on an airplane: Before further flight, do the 3. Will not affect intrastate aviation in This AD was prompted by reports of actions in Figure A–FBBAA-Sheet 03, Flow Alaska; and cracking of air intake cowls on Rolls-Royce Chart, of Airbus Mandatory Service Bulletin 4. Will not have a significant Trent engines, worn and detached A330–71–3025, excluding Appendices 01 economic impact, positive or negative, attachment links, and fractured thermal anti- and 02, dated January 10, 2011, as required on a substantial number of small entities ice (TAI) piccolo tubes. We are issuing this by paragraph (i) of this AD. AD to prevent degraded structural integrity of (3) If three or fewer broken piccolo tube under the criteria of the Regulatory the engine nose cowl in case of forward links are found, and the opposite engine air Flexibility Act. bulkhead damage in conjunction with a intake cowl of the same airplane has We prepared a regulatory evaluation broken piccolo tube, and damage to the accumulated more than 5,000 flight cycles of the estimated costs to comply with engine due to operation in icing conditions since the engine air intake cowl was first this AD and placed it in the AD docket. with reduced TAI performance. installed on an airplane: Before further flight, do a boroscope inspection of the piccolo tube Examining the AD Docket (f) Compliance links of the opposite engine air intake cowl You may examine the AD docket on You are responsible for having the actions side to detect broken links, in accordance the Internet at http:// required by this AD performed within the with the Accomplishment Instructions of www.regulations.gov; or in person at the compliance times specified, unless the Airbus Mandatory Service Bulletin A330–71– actions have already been done. 3025, excluding Appendices 01 and 02, dated Docket Operations office between 9 a.m. January 10, 2011. and 5 p.m., Monday through Friday, (g) Piccolo Tube Inspection (i) If the inspection findings of the piccolo except Federal holidays. The AD docket At the applicable time specified in tube links of the opposite engine air intake contains the NPRM (77 FR 26998, May paragraph (g)(1) or (g)(2) of this AD, do a cowl side indicate no broken piccolo tube 8, 2012), the regulatory evaluation, any boroscope inspection of each air intake cowl links: Before further flight, do the actions comments received, and other assembly of each engine to detect cracked or required by paragraph (i) of this AD. information. The street address for the fractured piccolo tubes, in accordance with (ii) If the inspection findings of the piccolo Docket Operations office (telephone the Accomplishment Instructions of Airbus tube links of the opposite engine air intake Mandatory Service Bulletin A330–71–3025, cowl side indicate one or more broken (800) 647–5527) is in the ADDRESSES excluding Appendices 01 and 02, dated piccolo tube links: Before further flight, do section. Comments will be available in January 10, 2011. If any cracked or fractured the actions specified in Note 01 of Figure A– the AD docket shortly after receipt. piccolo tube is found: Before further flight, FBBAA-Sheet 02, Flow Chart, of Airbus List of Subjects in 14 CFR Part 39 replace the affected engine air intake cowl Mandatory Service Bulletin A330–71–3025, with a new or serviceable engine air intake excluding Appendices 01 and 02, dated Air transportation, Aircraft, Aviation cowl, in accordance with the January 10, 2011, at the time specified in safety, Incorporation by reference, Accomplishment Instructions of Airbus Note 01 of Figure A–FBBAA-Sheet 02, Flow Safety. Mandatory Service Bulletin A330–71–3025, Chart, of Airbus Mandatory Service Bulletin excluding Appendices 01 and 02, dated A330–71–3025, excluding Appendices 01 Adoption of the Amendment January 10, 2011. and 02, dated January 10, 2011, except for the Accordingly, under the authority (1) For any engine air intake cowl that has instructions to ‘‘See Sheet 03.’’ Where Note accumulated fewer than 5,000 flight cycles 01 of Figure A–FBBAA-Sheet 02, Flow Chart, delegated to me by the Administrator, since its first installation on an airplane as of Airbus Mandatory Service Bulletin A330– the FAA amends 14 CFR part 39 as of the effective date of this AD: Inspect 71–3025, excluding Appendices 01 and 02, follows: within 24 months after the engine air intake dated January 10, 2011, specifies to ‘‘See cowl has accumulated 5,000 total flight Sheet 03’’ to do a detailed inspection of the PART 39—AIRWORTHINESS cycles. OBA and bulkhead, as specified in Rolls- DIRECTIVES (2) For any engine air intake cowl that has Royce Service Bulletin RB.211–71–AG416, accumulated 5,000 or more flight cycles since excluding Appendix 1, dated September 3, ■ 1. The authority citation for part 39 its first installation on an airplane as of the 2010: This AD requires the detailed continues to read as follows: effective date of this AD: Inspect within 24 inspection specified in Figure A–FBBAA- months after the effective date of this AD. Sheet 03, Flow Chart, of Airbus Mandatory Authority: 49 U.S.C. 106(g), 40113, 44701. Service Bulletin A330–71–3025, excluding (h) Piccolo Link Inspection Appendices 01 and 02, dated January 10, § 39.13 [Amended] If the inspection findings of paragraph (g) 2011, to be done in accordance with of this AD indicate no cracked or fractured paragraph (i) of this AD. ■ 2. The FAA amends § 39.13 by adding piccolo tube: Before further flight, do a the following new AD: boroscope inspection of the piccolo tube (i) Repetitive Outer Boundary Angle and Forward Bulkhead Inspection 2012–22–12 Airbus: Amendment 39–17248. links to detect broken links, in accordance Docket No. FAA–2012–0428; Directorate with the Accomplishment Instructions of If the results of the inspection required by Identifier 2011–NM–078–AD. Airbus Mandatory Service Bulletin A330–71– paragraph (h) of this AD indicate no broken 3025, excluding Appendices 01 and 02, dated piccolo tube links, or if the requirements in (a) Effective Date January 10, 2011. If no broken links are paragraph (h)(2) or (h)(3)(ii) of this AD This airworthiness directive (AD) becomes found: Before further flight, do the actions specify to do the actions in Figure A– effective December 14, 2012. required by paragraph (i) of this AD. FBBAA-Sheet 03, Flow Chart, of Airbus (1) If four or more broken piccolo tube Mandatory Service Bulletin A330–71–3025, (b) Affected ADs links are found: Before further flight, replace excluding Appendices 01 and 02, dated None. the affected engine air intake cowl with a January 10, 2011: Before further flight, do a new or serviceable engine air intake cowl, in boroscope inspection of the OBA and (c) Applicability accordance with the Accomplishment forward bulkhead to detect cracks or This AD applies to Airbus Model A330– Instructions of Airbus Mandatory Service fractures, in accordance with the 243, –243F, –341, –342, and –343 airplanes, Bulletin A330–71–3025, excluding Accomplishment Instructions of Airbus

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Mandatory Service Bulletin A330–71–3025, Repeat the inspections required by paragraph France; telephone +33 5 61 93 36 96; fax +33 excluding Appendices 01 and 02, dated (i) of this AD thereafter at the intervals 5 61 93 45 80; email airworthiness.A330- January 10, 2011; and the Accomplishment specified in the Accomplishment [email protected]; Internet http:// Instructions of Rolls-Royce Service Bulletin Instructions of Rolls-Royce Service Bulletin www.airbus.com. RB.211–71–AG416, excluding Appendix 1, RB.211–71–AG416, excluding Appendix 1, (4) For Rolls-Royce service information dated September 3, 2010. dated September 3, 2010. identified in this AD, contact Rolls-Royce (1) If the findings of the inspection are Plc, Technical Publications, P.O. Box 31, (k) Other FAA AD Provisions within the allowable damage limits, as Derby, DE24 8BJ, United Kingdom; telephone specified in the Accomplishment The following provisions also apply to this 44 (0) 1332 245882; fax 44 (0) 1332 249936; Instructions of Rolls-Royce Service Bulletin AD: Internet http://www.Rolls-Royce.com. RB.211–71–AG416, excluding Appendix 1, (1) Alternative Methods of Compliance (5) You may review copies of the service dated September 3, 2010: Do the actions in (AMOCs): The Manager, International information at the FAA, Transport Airplane paragraphs (i)(1)(i) and (i)(1)(ii) of this AD. Branch, ANM–116, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, (i) Repeat the inspection of the OBA and Directorate, FAA, has the authority to WA. For information on the availability of forward bulkhead thereafter at the repeat approve AMOCs for this AD, if requested this material at the FAA, call 425–227–1221. interval specified in Part 3.B. of the using the procedures found in 14 CFR 39.19. (6) You may view this service information Accomplishment Instructions of Rolls-Royce In accordance with 14 CFR 39.19, send your that is incorporated by reference at the Service Bulletin RB.211–71–AG416, request to your principal inspector or local National Archives and Records excluding Appendix 1, dated September 3, Flight Standards District Office, as Administration (NARA). For information on 2010. appropriate. If sending information directly the availability of this material at NARA, call (ii) Repeat the inspections specified in to the International Branch, send it to ATTN: 202–741–6030, or go to: http:// paragraphs (g) and (h) of this AD thereafter Vladimir Ulyanov, Aerospace Engineer, www.archives.gov/federal-register/cfr/ibr- at intervals not to exceed 2,500 flight cycles. International Branch, ANM–116, Transport locations.html. Airplane Directorate, FAA, 1601 Lind (2) If the findings of the inspection are not Issued in Renton, Washington, on October Avenue SW., Renton, WA 98057–3356; within the allowable damage limits, as 26, 2012. telephone (425) 227–1138; fax (425) 227– specified in the Accomplishment Kalene C. Yanamura, Instructions of Rolls-Royce Service Bulletin 1149. Information may be emailed to: 9- RB.211–71–AG416, excluding Appendix 1, [email protected]. Acting Manager, Transport Airplane dated September 3, 2010: Do the actions in Before using any approved AMOC, notify Directorate, Aircraft Certification Service. paragraphs (i)(2)(i) or (i)(2)(ii) of this AD, as your appropriate principal inspector, or [FR Doc. 2012–26892 Filed 11–8–12; 8:45 am] lacking a principal inspector, the manager of applicable. BILLING CODE 4910–13–P (i) If any OBA crack is 22 inches or greater, the local flight standards district office/ or any forward bulkhead crack is 13 inches certificate holding district office. The AMOC approval letter must specifically reference or greater: Before further flight, replace the this AD. DEPARTMENT OF TRANSPORTATION affected engine air intake cowl with a new or (2) Airworthy Product: For any requirement serviceable engine air intake cowl, in in this AD to obtain corrective actions from Federal Aviation Administration accordance with the Accomplishment a manufacturer or other source, use these Instructions of Airbus Mandatory Service actions if they are FAA-approved. Corrective 14 CFR Part 39 Bulletin A330–71–3025, excluding actions are considered FAA-approved if they Appendices 01 and 02, dated January 10, [Docket No. FAA–2012–0679; Directorate are approved by the State of Design Authority 2011. Identifier 2012–NM–063–AD; Amendment (or their delegated agent). You are required (ii) If any OBA crack is 15 inches or 39–17246; AD 2012–22–10] to assure the product is airworthy before it greater, but less than 22 inches, or any is returned to service. RIN 2120–AA64 forward bulkhead crack is 9 inches or greater, but less than 13 inches: Within 100 flight (l) Related Information cycles, replace the affected engine air intake Airworthiness Directives; Bombardier, Refer to MCAI European Aviation Safety Inc. Airplanes cowl with a new or serviceable engine air Agency Airworthiness Directive 2011–0062, intake cowl, in accordance with the dated April 4, 2011, and the service AGENCY: Federal Aviation Accomplishment Instructions of Airbus information specified in paragraphs (l)(1) and Administration (FAA), Department of Mandatory Service Bulletin A330–71–3025, (l)(2) of this AD, for related information. Transportation (DOT). excluding Appendices 01 and 02, dated (1) Airbus Mandatory Service Bulletin January 10, 2011. A330–71–3025, excluding Appendices 01 ACTION: Final rule. and 02, dated January 10, 2011. (j) Repetitive Inspections for Replaced SUMMARY: We are adopting a new Engine Air Intake Cowls (2) Rolls-Royce Service Bulletin RB.211– 71–AG416, excluding Appendix 1, dated airworthiness directive (AD) for certain If any engine air intake cowl is replaced in September 3, 2010. Bombardier, Inc. Model CL–600–2C10 accordance with the requirements of this AD (Regional Jet Series 700, 701, & 702) with an engine air intake cowl that has less (m) Material Incorporated by Reference airplanes, Model CL–600–2D15 than 5,000 flight cycles since the engine air (1) The Director of the Federal Register (Regional Jet Series 705) airplanes, intake cowl was first installed on an airplane: approved the incorporation by reference Model CL–600–2D24 (Regional Jet Repeat the inspection required by paragraph (IBR) of the service information listed in this Series 900) airplanes, and Model CL– (g) of this AD thereafter at the compliance paragraph under 5 U.S.C. 552(a) and 1 CFR time specified in paragraph (g)(1) of this AD. part 51. 600–2E25 (Regional Jet Series 1000) (1) If any engine air intake cowl is replaced (2) You must use this service information airplanes. This AD was prompted by a in accordance with the requirements of this as applicable to do the actions required by report that certain wing-to-fuselage AD with an engine air intake cowl with 5,000 this AD, unless the AD specifies otherwise. attachment nuts do not conform to the flight cycles or more since the engine air (i) Airbus Mandatory Service Bulletin certification design requirements for intake cowl was first installed on an airplane: A330–71–3025, excluding Appendices 01 dual locking features. This AD requires Repeat the inspections required by and 02, dated January 10, 2011. repetitive inspections to determine that paragraphs (g) and (h) of this AD thereafter (ii) Rolls-Royce Service Bulletin RB.211– cotter pins are installed at affected at intervals not to exceed 2,500 flight cycles. 71–AG416, excluding Appendix 1, dated (2) If any engine air intake cowl is replaced September 3, 2010. wing-to-fuselage attachment joints and in accordance with the requirements of this (3) For Airbus service information replacement if necessary. We are issuing AD with an engine air intake cowl with 5,000 identified in this AD, contact Airbus SAS— this AD to prevent loss of wing-to- flight cycles or more since the engine air Airworthiness Office—EAL, 1 Rond Point fuselage attachment joints, which could intake cowl was first installed on an airplane: Maurice Bellonte, 31707 Blagnac Cedex, result in the loss of the wing.

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DATES: This AD becomes effective Request for Credit for Previous Actions detail the scope of the Agency’s December 14, 2012. Mesa Airlines requested that authority. We are issuing this rulemaking under The Director of the Federal Register paragraph (i) of the NPRM (77 FR 40826, the authority described in ‘‘Subtitle VII, approved the incorporation by reference July 11, 2012), regarding credit for the Part A, Subpart III, Section 44701: of a certain publication listed in this AD previous actions, be revised to include as of December 14, 2012. General requirements.’’ Under that credit for Bombardier Maintenance section, Congress charges the FAA with ADDRESSES: You may examine the AD Review Board Report 57–10–305, Task docket on the Internet at http:// promoting safe flight of civil aircraft in 000–53–170–501, Detailed Inspection of air commerce by prescribing regulations www.regulations.gov or in person at the the Wing-to-Fuselage Attachment U.S. Department of Transportation, for practices, methods, and procedures Fittings—FS708.00, FS752.00, and the Administrator finds necessary for Docket Operations, M–30, West FS797.00 at LBL45.0 and RBL45.0, as Building Ground Floor, Room W12–140, safety in air commerce. This regulation compliance for the initial inspection is within the scope of that authority 1200 New Jersey Avenue SE., specified in paragraph (g) of the NPRM. because it addresses an unsafe condition Washington, DC. We disagree with the request to give that is likely to exist or develop on FOR FURTHER INFORMATION CONTACT: credit for the initial inspection by products identified in this rulemaking Jeffrey Zimmer, Aerospace Engineer, accomplishing the task specified by the action. Airframe & Mechanical Systems Branch, commenter. The intent of this AD is to ANE–171, New York Aircraft ensure cotter pin installation, and while Regulatory Findings Certification Office (ACO), FAA, 1600 Task 000–53–170–501 inspects for We determined that this AD will not Stewart Avenue, Suite 410, Westbury, corrosion and general condition of the have federalism implications under New York 11590; telephone (516) 228– wing attachment fittings, it does not Executive Order 13132. This AD will 7306; fax (516) 794–5531. specify inspecting the cotter pins. not have a substantial direct effect on SUPPLEMENTARY INFORMATION: Therefore, the cotter pins could be the States, on the relationship between missed during the inspection in Task the national government and the States, Discussion 000–53–170–501. We have not changed or on the distribution of power and We issued a notice of proposed the AD in this regard. responsibilities among the various levels of government. rulemaking (NPRM) to amend 14 CFR Conclusion part 39 to include an AD that would For the reasons discussed above, I apply to the specified products. That We reviewed the available data, certify that this AD: NPRM was published in the Federal including the comment received, and 1. Is not a ‘‘significant regulatory Register on July 11, 2012 (77 FR 40826). determined that air safety and the action’’ under Executive Order 12866; That NPRM proposed to correct an public interest require adopting the AD 2. Is not a ‘‘significant rule’’ under the unsafe condition for the specified as proposed, except for minor editorial DOT Regulatory Policies and Procedures products. The Mandatory Continuing changes. We have determined that these (44 FR 11034, February 26, 1979); 3. Will not affect intrastate aviation in Airworthiness Information (MCAI) minor changes: • Alaska; and states: Are consistent with the intent that was proposed in the NPRM (77 FR 4. Will not have a significant The manufacturer has determined that wing- 40826, July 11, 2012) for correcting the economic impact, positive or negative, to-fuselage attachment nuts, part number (P/ unsafe condition; and on a substantial number of small entities N) SH670–35635–1, SH670–35440–951, • under the criteria of the Regulatory SH670–35440–3, SH670–35635–1 and Do not add any additional burden upon the public than was already Flexibility Act. 95136D–2412, installed at six attachment We prepared a regulatory evaluation proposed in the NPRM (77 FR 40826, joint locations, do not conform to the of the estimated costs to comply with certification design requirements for dual July 11, 2012). locking features. The nuts are not of the self- this AD and placed it in the AD docket. Costs of Compliance locking type as required and do not provide Examining the AD Docket the frictional thread interference required to We estimate that this AD will affect prevent the nut from backing off the bolt. As You may examine the AD docket on 366 products of U.S. registry. We also the Internet at http:// a result, only a single locking device, the estimate that it will take about 5 work- cotter pin, is provided at these critical joints. www.regulations.gov; or in person at the In the case where a nut becomes loose, in hours per product to comply with the Docket Operations office between 9 a.m. combination with a missing or broken cotter basic requirements of this AD. The and 5 p.m., Monday through Friday, pin, the attachment bolt at the wing-to- average labor rate is $85 per work-hour. except Federal holidays. The AD docket fuselage joint could migrate and fall out. Loss Based on these figures, we estimate the contains the NPRM (77 FR 40826, July of two attachment joints could potentially cost of this AD to the U.S. operators to 11, 2012), the regulatory evaluation, any result in the loss of the wing. be $155,550, or $425 per product. comments received, and other This [Transport Canada Civil Aviation] We have received no definitive data information. The street address for the Airworthiness Directive (AD) mandates a that would enable us to provide cost Docket Operations office (telephone [repetitive] detailed visual inspection (DVI) estimates for the on-condition actions (800) 647–5527) is in the ADDRESSES of each affected wing-to-fuselage attachment specified in this AD. We have no way joint to ensure that a cotter pin is installed. section. Comments will be available in of determining the number of products the AD docket shortly after receipt. The required actions also include that may need these actions. replacing any missing cotter pin. You List of Subjects in 14 CFR Part 39 Authority for This Rulemaking may obtain further information by Air transportation, Aircraft, Aviation examining the MCAI in the AD docket. Title 49 of the United States Code safety, Incorporation by reference, specifies the FAA’s authority to issue Safety. Comments rules on aviation safety. Subtitle I, We gave the public the opportunity to section 106, describes the authority of Adoption of the Amendment participate in developing this AD. We the FAA Administrator. ‘‘Subtitle VII: Accordingly, under the authority have considered the comment received. Aviation Programs,’’ describes in more delegated to me by the Administrator,

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the FAA amends 14 CFR part 39 as (h) Corrective Action (i) Bombardier Service Bulletin 670BA–53– follows: If any cotter pin is found missing during 042, Revision A, dated April 27, 2012. any inspection required by paragraph (g) of (ii) Reserved. PART 39—AIRWORTHINESS this AD: Before further flight, replace any (3) For service information identified in DIRECTIVES missing cotter pin using a method approved this AD, contact Bombardier, Inc., 400 Coˆte- by either the Manager, New York Aircraft Vertu Road West, Dorval, Que´bec H4S 1Y9, Canada; telephone 514–855–5000; fax 514– ■ 1. The authority citation for part 39 Certification Office (ACO), ANE–170, FAA; or Transport Canada Civil Aviation (or its 855–7401; email continues to read as follows: delegated agent). [email protected]; Internet http:// Authority: 49 U.S.C. 106(g), 40113, 44701. www.bombardier.com. (i) Credit for Previous Actions (4) You may review copies of the service information at the FAA, Transport Airplane § 39.13 [Amended] This paragraph provides credit for the actions required by paragraph (g) of this AD, Directorate, 1601 Lind Avenue SW., Renton, ■ 2. The FAA amends § 39.13 by adding if those actions were performed before the WA. For information on the availability of this material at the FAA, call 425–227–1221. the following new AD: effective date of this AD using Bombardier Service Bulletin 670BA–53–042, dated (5) You may view this service information 2012–22–10 Bombardier, Inc.: Amendment December 21, 2011, which is not that is incorporated by reference at the 39–17246. Docket No. FAA–2012–0679; incorporated by reference in this AD. National Archives and Records Directorate Identifier 2012–NM–063–AD. Administration (NARA). For information on (j) Other FAA AD Provisions the availability of this material at NARA, call (a) Effective Date The following provisions also apply to this 202–741–6030, or go to: http:// This airworthiness directive (AD) becomes AD: www.archives.gov/federal-register/cfr/ibr- effective December 14, 2012. (1) Alternative Methods of Compliance locations.html. (AMOCs): The Manager, New York ACO, (b) Affected ADs Issued in Renton, Washington, on October ANE–170, FAA, has the authority to approve 24, 2012. None. AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In Kalene C. Yanamura, (c) Applicability accordance with 14 CFR 39.19, send your Acting Manager, Transport Airplane This AD applies to Bombardier, Inc. Model request to your principal inspector or local Directorate, Aircraft Certification Service. CL–600–2C10 (Regional Jet Series 700, 701, Flight Standards District Office, as [FR Doc. 2012–26961 Filed 11–8–12; 8:45 am] & 702) airplanes, serial numbers 10002 appropriate. If sending information directly BILLING CODE 4910–13–P through 10999 inclusive; Model CL–600– to the manager of the ACO, send it to ATTN: 2D15 (Regional Jet Series 705) and CL–600– Program Manager, Continuing Operational 2D24 (Regional Jet Series 900) airplanes, Safety, FAA, New York ACO, 1600 Stewart DEPARTMENT OF TRANSPORTATION serial numbers 15001 through 15990 Avenue, Suite 410, Westbury, New York inclusive; and Model CL–600–2E25 (Regional 11590; telephone (516) 228–7300; fax (516) Federal Aviation Administration Jet Series 1000) airplanes, serial numbers 794–5531. Before using any approved AMOC, notify your appropriate principal inspector, 19001 through 19990 inclusive; certificated 14 CFR Part 400 in any category. or lacking a principal inspector, the manager of the local flight standards district office/ [Docket No. FAA–2012–0318; Amdt. No. (d) Subject certificate holding district office. The AMOC 400–4] Air Transport Association (ATA) of approval letter must specifically reference America Code 53, Fuselage. this AD. RIN 2120–AK16 (2) Airworthy Product: For any requirement (e) Reason in this AD to obtain corrective actions from Voluntary Licensing of Amateur This AD was prompted by a report that a manufacturer or other source, use these Rocket Operations; Withdrawal certain wing-to-fuselage attachment nuts do actions if they are FAA-approved. Corrective AGENCY: not conform to the certification design actions are considered FAA-approved if they Federal Aviation requirements for dual locking features. We are approved by the State of Design Authority Administration (FAA), DOT. are issuing this AD to prevent loss of wing- (or their delegated agent). You are required ACTION: Direct Final rule, withdrawal. to-fuselage attachment joints, which could to assure the product is airworthy before it result in the loss of the wing. is returned to service. SUMMARY: The FAA is withdrawing a (k) Related Information previously published direct final rule (f) Compliance that would have allowed launch You are responsible for having the actions (1) Refer to MCAI Canadian Airworthiness operators that conduct certain amateur required by this AD performed within the Directive CF–2012–10, dated March 12, 2012; and Bombardier Service Bulletin 670BA–53– rocket launches to voluntarily apply for compliance times specified, unless the a commercial space transportation actions have already been done. 042, Revision A, dated April 27, 2012; for related information. license or experimental permit. The (g) Repetitive Detailed Inspection (2) For Bombardier service information FAA is withdrawing this action because Within 3,000 flight hours or 18 months identified in this AD, contact Bombardier, of the adverse comments it received. ˆ after the effective date of this AD, whichever Inc., 400 Cote-Vertu Road West, Dorval, DATES: The direct final rule published ´ occurs first: Perform a detailed inspection of Quebec H4S 1Y9, Canada; telephone 514– on August 22, 2012, at 77 FR 50584 is each affected wing-to-fuselage attachment 855–5000; fax 514–855–7401; email [email protected]; Internet http:// withdrawn, effective November 8, 2012. joint, in accordance with the www.bombardier.com. FOR FURTHER INFORMATION CONTACT: For Accomplishment Instructions of Bombardier technical questions concerning this Service Bulletin 670BA–53–042, Revision A, (l) Material Incorporated by Reference action, contact Shirley McBride, Senior dated April 27, 2012. Repeat the inspection (1) The Director of the Federal Register thereafter at intervals not to exceed 6,600 Transportation Industry Analyst, Office approved the incorporation by reference of Commercial Space Transportation, flight hours. (IBR) of the service information listed in this Note 1 to paragraph (g) of this AD: The paragraph under 5 U.S.C. 552(a) and 1 CFR Regulations and Analysis Division, compliance time in this AD differs from the part 51. Federal Aviation Administration, 800 recommended compliance time specified in (2) You must use this service information Independence Avenue SW., Bombardier Service Bulletin 670BA–53–042, as applicable to do the actions required by Washington, DC 20591; telephone (202) Revision A, dated April 27, 2012. this AD, unless the AD specifies otherwise. 267–7470; facsimile (202) 267–5463;

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email [email protected]. For or committing the agency to any future www.regulations.gov, which is the legal questions concerning this action, course of action. Federal eRulemaking Portal. Follow the contact Laura Montgomery, Senior The FAA withdraws Amendment No. instructions online for submitting Attorney for Commercial Space 400–4 published at 77 FR 50584 on comments. Transportation, Office of the Chief August 22, 2012. Facsimile: OSHA allows facsimile Counsel, Regulations Division, Federal Issued in Washington, DC, on November 6, transmission of comments that are 10 Aviation Administration, 800 2012. pages or fewer in length (including Independence Avenue SW., Michael P. Huerta, attachments). Fax these documents to Washington, DC 20591; telephone (202) Acting Administrator. the OSHA Docket Office at (202) 693– 267–3150; facsimile (202) 267–7971; [FR Doc. 2012–27503 Filed 11–7–12; 4:15 pm] 1648; OSHA does not require hard email [email protected]. BILLING CODE 4910–13–P copies of these documents. Instead of SUPPLEMENTARY INFORMATION: transmitting facsimile copies of attachments that supplement these Background DEPARTMENT OF LABOR documents (e.g., studies, journal On August 22, 2012, the FAA articles), commenters must submit these published a direct final rule that would Occupational Safety and Health attachments to the OSHA Docket Office, have amended the scope of its chapter Administration Technical Data Center, Room N–2625, III regulations to give operators of Class OSHA, U.S. Department of Labor, 200 3 advanced high-power rockets the 29 CFR Part 1926 Constitution Ave., NW., Washington, option of applying for a chapter III DC 20210. These attachments must launch license or permit, or continuing [Docket ID–OSHA–2012–0025] clearly identify the sender’s name, the to operate under 14 CFR chapter I, part RIN 1218–AC75 date, and the docket number (OSHA– 101. The direct final rule would have 2012–0025), so that the Docket Office been strictly voluntary. Only those Revising the Exemption for Digger can attach them to the appropriate operators that wished to apply under Derricks in the Cranes and Derricks in document. chapter III for a license needed to do so. Construction Standard Regular or express mail, hand However, once an operator accepted an AGENCY: Occupational Safety and Health delivery, or messenger (courier) service: FAA license or permit, part 101 would Administration (OSHA); Labor. Submit comments and any additional no longer have applied, and the operator information or material to the OSHA ACTION: Direct final rule. would have been governed by the Docket Office, Docket No. OSHA–2012– provisions of chapter III for those SUMMARY: OSHA is broadening the 0025 or RIN No. 1218–AC75, Technical rockets. exemption for digger derricks in its Data Center, Room N–2625, OSHA, U.S. The Commercial Space Launch Act standard for cranes and derricks. OSHA Department of Labor, 200 Constitution provides that the United States should issued a final standard updating the Ave., NW., Washington, DC 20210; encourage private sector launches, requirements for cranes and derricks on telephone: (202) 693–2350. (OSHA’s reentries, and associated services. The August 9, 2010, and the Edison Electric TTY number is (877) 889–5627.) Contact FAA initiated the direct final rule Institute (EEI) petitioned for review of the OSHA Docket Office for information primarily to support those launch the standard in the United States Court about security procedures concerning operators that, under contract with of Appeals. After petitioning, EEI delivery of materials by express mail, NASA, were required by NASA to provided OSHA with new information hand delivery, and messenger service. obtain an FAA launch license. Because regarding digger derricks. OSHA The Docket Office will accept deliveries the rule was strictly voluntary, the FAA reviewed the additional information and (express mail, hand delivery, and believed there was good cause to issue the rulemaking record, and decided to messenger service) during the Docket it as a direct final rule. broaden the exemption for digger Office’s normal business hours, 8:15 Reason for Withdrawal derricks used in the electric-utility a.m. to 4:45 p.m. ET. industry by means of this direct final Docket: To read or download The FAA is withdrawing the direct rule. comments or other information or final rule because the agency received material in the docket, go to http:// several adverse comments. In brief, the DATES: This direct final rule will www.regulations.gov or to the OSHA commenters raised issues concerning become effective on February 7, 2013, Docket Office at the address above. the potential cost to small businesses unless OSHA receives significant Documents in the docket are listed in and the government, both in terms of adverse comment to this direct final rule the http://www.regulations.gov index; the resources necessary for preparing by December 10, 2012. All submissions, however, some information (e.g., and evaluating applications and in whether transmitted, mailed, or copyrighted material) is not available terms of the conditional payment of delivered, must bear a postmark or publicly to read or download through excess claims commonly referred to as provide other evidence of the this Web site. All submissions, ‘‘indemnification.’’ Others expressed submission date. including copyrighted material, are doubts about whether amateur rockets ADDRESSES: Submit comments available for inspection at the OSHA could ever meet chapter III (including comments to the Docket Office. Contact the OSHA Docket requirements, whether applying those information-collection (paperwork) Office for assistance in locating docket requirements to smaller vehicles made determination described under the submissions. sense or was necessary, and whether section titled AGENCY safety issues were created. DETERMINATIONS), hearing requests, FOR FURTHER INFORMATION CONTACT: and other information and materials, General information and press inquiries: Conclusion identified by Docket No. OSHA–2012– Mr. Frank Meilinger, Director, OSHA Withdrawal of Amendment No. 400– 0025, by any of the following methods: Office of Communications, Room N– 4 does not preclude the FAA from a Electronically: Submit comments and 3647, U.S. Department of Labor, 200 rulemaking on the subject in the future attachments electronically at http:// Constitution Avenue NW., Washington,

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DC 20210; telephone: (202) 693–1999; agency may publish an identical proceed with the companion proposed email: [email protected]. proposed rule at the same time. If the rule. In the event that OSHA withdraws Technical inquiries: Mr. Garvin agency receives no significant adverse the direct final rule because of Branch, Directorate of Construction, comment in response to the direct final significant adverse comment, OSHA Room N–3468, OSHA, U.S. Department rule, the rule goes into effect. OSHA will consider all timely comments of Labor, 200 Constitution Avenue NW., typically confirms the effective date of received in response to the direct final Washington, DC 20210; telephone: (202) a direct final rule through a separate rule when it continues with the 693–2020; fax: (202) 693–1689; email: Federal Register notice. If the agency proposed rule. After carefully [email protected]. receives a significant adverse comment, considering all comments to the direct For copies of this Federal Register the agency withdraws the direct final final rule and the proposal, OSHA will notice, news releases, and other relevant rule and treats such comment as a decide whether to publish a new final document: Electronic copies of these response to the proposed rule. An rule. OSHA determined that the subject documents are available at OSHA’s Web agency typically uses direct final of this rulemaking is suitable for direct page at http://www.osha.gov. rulemaking when an agency anticipates final rulemaking. OSHA originally SUPPLEMENTARY INFORMATION: that a rule will not be controversial. included the digger-derrick exemption For purposes of this direct final rule, in the proposed Cranes and Derricks in Table of Contents a significant adverse comment is one Construction standard as a result of that explains why the amendments to I. Request for Comment negotiated rulemaking involving OSHA’s digger-derrick exemption stakeholders from many affected sectors. II. Direct Final Rulemaking would be inappropriate. In determining III. Discussion of the Digger-Derrick The existing rule for Cranes and Exemption in 29 CFR 1926, Subpart CC whether a comment necessitates Derricks in Construction, subpart CC of A. Background withdrawal of the direct final rule, 29 CFR 1926, exempts the majority of B. Changes to the Text of the Exemption in OSHA will consider whether the digger derricks used in the 29 CFR 1926.1400(c)(4) comment raises an issue serious enough telecommunications and electric-utility C. Discussion of Conforming Revisions to to warrant a substantive response in a industries from the requirements of that 29 CFR 1926, Subpart V (Power notice-and-comment process. OSHA subpart. Because the revision specified Transmission and Distribution) will not consider a comment in this direct final rule extends the IV. Agency Determinations recommending an additional A. Significant Risk exemption to a small number of digger amendment to be a significant adverse derricks used in the electric-utility B. Final Economic Analysis and Final comment unless the comment states Regulatory Flexibility Analysis industry, and does not impose any new C. Technological Feasibility why the direct final rule would be costs or duties, OSHA does not expect D. Paperwork Reduction Act of 1995 ineffective without the addition. objections from the public to this E. Federalism Furthermore, OSHA will not consider a rulemaking action. F. State Plan States comment requesting any narrowing of G. Unfunded Mandates Reform Act the existing digger-derrick exemption to III. Discussion of the Digger-Derrick H. Consultation and Coordination With be a significant adverse comment Exemption in 29 CFR 1926, Subpart CC Indian Tribal Governments because narrowing the existing List of Subjects in 29 CFR Part 1926 A. Background of the Digger-Derrick exemption is beyond the scope of this Exemption Authority and Signature rulemaking. Moreover, a comment Amendments to Standards requesting an expansion of the A ‘‘digger derrick’’ or ‘‘radial boom exemption to encompass activities not derrick’’ is a specialized type of I. Request for Comment related to digger-derrick use by electric equipment designed to install utility OSHA requests comments on all utilities also would be beyond the scope poles. A digger derrick typically is issues related to this direct final rule, of this rulemaking, and OSHA will not equipped with augers to drill holes for including economic, paperwork, or consider such a comment to be a the poles and with a hydraulic boom to other regulatory impacts of this rule on significant adverse comment unless the lift the poles and set them in the holes. the regulated community. If OSHA commenter explains why the provisions Employers also use the booms to lift receives no significant adverse of the direct final rule, as these objects other than poles; accordingly, comment, OSHA will publish a Federal provisions apply to digger derricks, electric utilities, telecommunication Register document confirming the would be ineffective without the companies, and their contractors use effective date of this direct final rule expansion. booms both to place objects on utility and withdrawing the companion In addition to publishing this direct poles and for general lifting purposes at proposed rule published in the final rule, OSHA is publishing a worksites (Docket ID OSHA–2007– ‘‘Proposed Rules’’ section of today’s companion proposed rule in the 0066–0139.1). When OSHA Federal Register. Such confirmation ‘‘Proposed Rules’’ section of today’s promulgated subpart V (Power may include minor stylistic or technical Federal Register. The comment period Transmission and Distribution) in 1972, changes to the document. For the for the proposed rule runs concurrently it excluded digger derricks from certain purpose of judicial review, OSHA views with that of the direct final rule. OSHA requirements of 29 CFR 1926, subpart N, the date of confirmation of the effective also will treat comments received on the the predecessor to the current 29 CFR date of this direct final rule as the date companion proposed rule as comments 1926, subpart CC, standard. of promulgation. regarding the direct final rule. Likewise, OSHA developed the proposed OSHA will consider significant adverse standard for cranes and derricks in II. Direct Final Rulemaking comment submitted to the direct final construction through a negotiated In direct final rulemaking, an agency rule as comment to the companion rulemaking involving stakeholders from publishes a direct final rule in the proposed rule. Therefore, if OSHA many affected sectors. The proposed Federal Register with a statement that receives a significant adverse comment standard included a limited exemption the rule will go into effect unless the on either this direct final rule or the for digger derricks (73 FR 59714, 59916 agency receives significant adverse proposed rule, it will publish a timely (Oct. 9, 2008)). After the publication of comment within a specified period. The withdrawal of this direct final rule and the proposed rule, OSHA received many

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comments criticizing the scope of the On October 6, 2010, Edison Electrical electric utilities typically place exemption because the scope applied to Institute petitioned for review of the distribution transformers in a right of digger derricks designed for the electric- Cranes and Derricks in Construction way along front property lines, close to utility industry, and then only when standard in the U.S. Court of Appeals a roadway, or along rear property lines, used to dig holes for utility work. for the District of Columbia. During irrespective of whether the transformers Commenters noted that customary use subsequent discussions with OSHA, EEI are pole- or pad-mounted. In those of the digger derrick also involved provided new information to OSHA cases, the lifting radius of a digger placing a pole in the hole and attaching regarding the use of digger derricks in derrick placing a transformer on a pad transformers and other items to the pole. the electric-utility industry and the is similar to the lifting radius of a digger Commenters complained that the resulting impact on the utilities’ derrick placing a transformer on a pole. exemption would be largely operations under the current digger- Consequently, the lifting forces on a meaningless unless it also encompassed derrick exemption in subpart CC. digger derrick should be approximately these functions. Several representatives According to EEI, the exemption from the same regardless of whether the of the telecommunications industry subpart CC covers roughly 95 percent of transformer is pole- or pad-mounted noted that the industry used digger work conducted by digger derricks in (see, e.g., OSHA–2012–0025–0003). derricks routinely for similar purposes, the electric-utility industry (see OSHA– Finally, the approximate height of the and requested that OSHA expand the 2012–0025–0004 for EEI Dec. 7, 2010, transformer relative to the employee digger-derrick exemption to encompass letter, page 2). The majority of the work installing the transformer is the same for telecommunications work in addition to under the remaining five percent is the two types of transformers. An electric-utility work (Docket ID OSHA– work that is closely related to the employee installing a pad-mounted 2007–0066–0234 and OSHA–2007– exempted work. Id. For example, when transformer is on the ground, near the 0066–0129.1). electric utilities use digger derricks to pad, whereas an employee installing a When OSHA issued the final Cranes perform construction work involving pole-mounted transformer is either on and Derricks in Construction rule, it pole installations, the same digger- the pole, or in an aerial lift, near the noted concerns about the scope of the derrick crew that performs the pole mounting point for the transformer. In exemption, and broadened the scope of work typically installs pad-mount either case, the transformer would be the exemption (see 75 FR 47906, 47924– transformers on the ground as part of around the same height as the 47926, and 48136 (Aug. 9, 2010)). the same power system as the poles. employee. Current subpart CC, therefore, exempts While the pole work is exempt under 29 Because the same workers generally digger derricks used by both the CFR 1926.1400(c)(4), the placement of perform both types of work, utility electric-utility and the the pad-mount transformer on the employers must, when the standard telecommunications industries, and ground is not. becomes fully effective in November encompasses all pole work in these Furthermore, in comparison to 2014, incur the cost of meeting all other industries, including placing utility currently exempted pole work, OSHA requirements in subpart CC, including poles in the ground and attaching believes most (if not all) of the the operator-certification requirements, transformers and other equipment to the remaining five percent of work is at for those workers to perform the five poles (see 29 CFR 1400(c)(4)). In that least as safe. Weight measurements percent of the work not currently exemption, OSHA clarifies that digger provided by EEI demonstrate that exempted. The result could be a sizable derricks in construction that are exempt transformers placed on a pad on the cost (about $21.6 million annually) for from subpart CC must still comply with ground are roughly the same weight as, an activity that does not appear the applicable worker protections in the or in some cases lighter than, the weight significantly more dangerous than the OSHA standards governing electric- of the transformers lifted onto the poles, type of activity that OSHA already utility and telecommunications work at or the poles themselves (see OSHA– exempted. (See Section IV.B. (Final §§ 1910.268 and 1910.269. The existing 2012–0025–0003 for EEI handout, Economic Analysis and Final exemption in § 1926.1400(c) states that ‘‘Typical Weights’’ chart).2 In addition, Regulatory Flexibility Act Analysis) in the subpart does not cover digger this preamble for a summary of these derricks when used for augering holes exemption in § 1926.400(c)(4). The scope costs.) OSHA did not consider this for poles carrying electric and limitations in § 1910.268(a) (such as the language stating that it does not apply to construction) are result when it promulgated the telecommunication lines, placing and irrelevant to application of the exemption. If an standard. removing the poles, and for handling employer uses a digger derrick for OSHA acknowledges the arguments associated materials to be installed on or telecommunications construction work and does that there are minimal safety benefits removed from the poles. Digger derricks not comply with the provisions in § 1910.268, then attributable to imposing the standard’s that employer fails to qualify for the exemption in used in work subject to 29 CFR part § 1926.400(c)(4). As a result, that employer must requirements on the remaining five 1926, subpart V, must comply with 29 comply with all of the requirements in subpart CC percent of non-exempted work; CFR 1910.269. Digger derricks used in of part 1926, including the operator-certification moreover, the exempted digger-derrick construction work for requirements in § 1926.1427. If the employer fails operations are still subject to the to comply with subpart CC, and cannot demonstrate telecommunication service (as defined that it complied with § 1910.268 for protections afforded to workers by at 29 CFR 1910.268(s)(40)) must comply telecommunications work, or § 1910.269 for OSHA’s electric-utility and with 29 CFR 1910.268. electric-utility work, then OSHA will cite the telecommunications standards When the activities are exempt from employer under subpart CC (not § 1910.268 or (§ 1910.269, subpart V of 29 CFR 1926, § 1910.269). If the employer demonstrates that it subpart CC of 29 CFR 1926, they must complies with the exemption in subpart CC, but and § 1910.268, respectively). OSHA still comply with all other applicable does not comply with the separate requirements in construction standards, such as 29 CFR subpart O applicable to all motorized vehicles in those pads. If utilities do use digger derricks to lift 1926, subpart O (Motor Vehicles, construction, then OSHA will cite the employer pads, EEI’s presentation indicates that digger under subpart O. Note that this explanation does derricks lift the transformers separately. Because Mechanized Equipment, and Marine not suggest that OSHA is restricting its enforcement 1 the surface area of these pads is comparable to the Operations), and subpart V. discretion on whether to issue citations at all. transformers on them, and because these pads are 2 EEI’s chart does not show weights for concrete generally only a few hundred millimeters thick, 1 For telecommunications work, compliance with and plastic transformer pads, and EEI did not OSHA does not believe that the pads weigh any the provisions of § 1910.268 is a condition of the indicate that utilities use digger derricks to place more than transformers or poles.

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also notes that the largest labor within this exemption to perform employers using digger derricks for organization for workers in the electric- unrelated tasks such as the construction work covered by subpart V to comply utility industry, the International of a building or the foundation or with the requirements in § 1910.269. Brotherhood of Electrical Workers, structural components of a substation However, in the 2010 final rule for participated in settlement discussions, before the installation of electric power- Cranes and Derricks in Construction, corroborated the general validity of the transmission or power-distribution OSHA also revised 29 CFR information provided by EEI, and equipment. A digger derrick used for 1926.952(c)(2) of subpart V to require actively supported EEI’s request for an this type of construction will still be digger derricks used for the purposes expanded digger-derrick exemption. In subject to the requirements in 29 CFR exempted from subpart CC to comply light of these factors, OSHA is removing 1926, subpart CC, and operators will with § 1910.269. Thus, although the the burdens on employers for the have to be certified in accordance with revised exemption in this direct final remaining five percent of non-exempted § 1926.1427. rule specifies compliance with subpart V instead of § 1910.269, there is no work, and revising the digger-derrick B. Changes to the Text of the Exemption substantive revision to digger derricks exemption to include all digger derricks in 29 CFR 1926.1400(c)(4) used in construction work subject to 29 used for augering holes and handling CFR 1926, subpart V. Based on its OSHA is revising the exemption in 29 associated materials. The primary estimates in the Final Economic CFR 1926.1400(c)(4) to include within purpose for this revision is to harmonize Analysis in the 2010 final rule, the the exemption ‘‘any other work subject the § 1926.1400(c)(4) exemption with 29 Agency determined that expanding the to subpart V of 29 CFR part 1926.’’ This CFR 1926.952(c)(2) to ensure that non- exemption for digger derricks will revision expands the exemption to pole digger-derrick work covered by enable employers in NAICS 221120 to remove from coverage under subpart CC subpart V receives the same protections avoid compliance costs of about $15.9 of 29 CFR 1926 the types of non-pole, as pole work covered by subpart V. million per year, while employers in digger-derrick work described by EEI. OSHA is not expanding the exemption C. Discussion of Conforming Revisions NAICS 221110 will avoid about $5.7 to 29 CFR 1926, Subpart V million per year, for a total cost savings for pole work performed by employers of about $21.6 million annually. in the telecommunications industry As part of this harmonizing process, because no party raised or requested OSHA also is revising the corresponding When the Agency promulgated the such an exemption in the litigation; provision in subpart V that requires final Cranes and Derricks in therefore, this issue is outside the scope compliance with § 1910.269 for all Construction rule, OSHA’s primary of this rulemaking. digger-derrick work exempted from concern about extending the digger- The Agency also is making several subpart CC, including §§ 1910.269(p) derrick exemption beyond pole work minor clarifications to the text of the (Mechanical equipment), 1910.269(a)(2) was that such an extension would exemption. First, OSHA is making a (Training), and 1910.269(l) (Working on provide employers with an incentive to minor grammatical clarification by or near exposed energized parts) (see use digger derricks on construction sites replacing ‘‘and’’ with ‘‘or’’ in the phrase new 29 CFR 1926.952(c)(2)). When to perform construction tasks normally ‘‘poles carrying electric or OSHA promulgated subpart CC of 29 handled by cranes—tasks that are telecommunication lines’’ (emphasis CFR 1926 in 2010, the Agency also beyond the original design capabilities added). This revision will ensure that revised § 1926.952(c)(2) in subpart V of of a digger derrick. In discussing this the regulated community does not its construction standards (75 FR concern, OSHA stated, ‘‘[T]he general misconstrue the exemption as limited to 48135). The revision mirrored the lifting work done at those other poles that carry both electric and terminology in the digger-derrick worksites would be subject to this telecommunications lines. This exemption in § 1926.1400(c)(4), and standard if done by other types of lifting clarification is consistent with OSHA’s required employers using digger equipment, and the same standards explanation in the preamble of the derricks so exempted to comply with should apply as apply to that equipment Cranes and Derricks in Construction § 1910.269 (Electric power generation, * * *.’’ (75 FR 47925). OSHA final rule (see 75 FR 47925). transmission, and distribution). In acknowledges that revising the Second, OSHA is adding the phrase making this revision, the Agency noted exemption would extend the digger- ‘‘to be eligible for this exclusion’’ at the that it added specific minimum derrick exemption to include some work beginning of the sentence requiring clearance-distance requirements, which at substations. However, EEI indicated compliance with § 1910.268 and subpart are applicable to subpart V work, to the that the employers in the electric-utility V of 29 CFR 1926, respectively. This cranes and derricks in construction industry limit such uses to assembly or revision limits the exemption to the use rules at subpart CC, and explained that arrangement of substation components, of digger derricks that comply with the it revised § 1926.952(c) to require digger and that these employers use other requirements in subpart V or § 1910.268; derricks to comply with § 1910.269 to types of cranes instead of digger if an employer uses a digger derrick for provide ‘‘comparable safety derricks to perform lifting and subpart V or telecommunications work requirements’’ (75 FR 47921). installation work at substations (see without complying with all of the As revised, paragraph § 1926.952(c)(2) OSHA–2012–0025–0005 for Jan. 2011 requirements in subpart V or § 1910.268, requires employers using digger derricks EEI letter). If OSHA finds that, should then the work is not exempt, and the for subpart V work and, thus, not this direct final rule become a final rule, employer must comply with all of the subject to the requirements of subpart employers are using digger derricks requirements of subpart CC of 29 CFR CC of 29 CFR 1926, to comply with the increasingly for other tasks, the Agency 1926. This clarification is consistent requirements in § 1910.269. OHSA also may revisit this issue and adjust the with OSHA’s explanation of the is clarifying that paragraph (c)(2) applies exemption accordingly. The Agency exemption in the preamble of the final in addition to, not in place of, the also recognizes that, because the rule (see 75 FR 47925–47926). general requirement in § 1926.952(c) exemption only applies to work subject Third, OSHA is replacing the that all equipment (including digger to the electrical-power and reference to § 1910.269 with a reference derricks) must comply with subpart O of telecommunications standards, to 29 CFR 1926, subpart V. The current 29 CFR 1926. As noted in the preamble employers cannot use digger derricks exemption in § 1926.1400(c)(4) requires to the subpart CC final rule, OSHA

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currently is developing a rule that will Occupational Safety and Health Act of This direct final rule will eliminate amend subpart V to avoid 1970 (‘‘OSH Act’’; 29 U.S.C. 651 et seq.) nearly all of the estimated $21.6 million inconsistencies between subpart V of and Executive Orders 12866 and 13563. per year in costs associated with digger the construction standards and OSHA also published a final regulatory derricks. These estimated cost savings § 1910.269 (see 70 FR 34822 (June 15, flexibility analysis as required by the may be slightly overstated because 2005)). Pending completion of that Regulatory Flexibility Act (5 U.S.C. OSHA noted in its FEA that the cost rulemaking, digger derricks excluded 601–612). assumptions might not represent the from subpart CC of 29 CFR 1926 will be In the FEA for the final rule (OSHA– most efficient way to meet the subject to the same requirements 2007–0066–0422), the Agency estimated requirements of the rule. However, regardless of whether employers use that there were about 10,000 crane OSHA wanted to assure the regulated them for work covered by subpart V or operators in NAICS 221110 Electric community that, even with somewhat work covered by § 1910.269, and Power Generation, and about 20,000 overstated cost estimates, the rule regardless of whether employers use crane operators in NAICS 221120 would still be economically feasible. them for pole work or other subpart V Electric Power Transmission, Control, In its original FEA (OSHA–2007– work. and Distribution. OSHA based these 0066–0422), OSHA reported an average figures on estimates of the number of of 0.5 crane-related fatalities per year in IV. Agency Determinations construction work crews in these SIC codes NAICS 221110 and NAICS A. Significant Risk industries from its subpart V FEA, with 221120. However, the original FEA did an allowance (to assure maximum not indicate that any of these fatalities The purpose of the Occupational flexibility) that there be three trained involved digger derricks or other Safety and Health Act of 1970 (OSH Act; crane operators for every work crew. equipment covered by the standard. 29 U.S.C. 651 et al.) is ‘‘to assure so far Based on submissions to the record, Moreover, in light of the information as possible every working man and OSHA estimated that 85 percent of these provided by EEI, there is no indication woman in the Nation safe and healthful 30,000 operators (25,500) worked on that the additional five percent of working conditions and to preserve our digger derricks, while 15 percent of the digger-derrick activity exempted human resources’’ (29 U.S.C. 651(b)). To operators operated truck-mounted through this rulemaking poses any achieve this goal, Congress authorized cranes, or boom trucks; therefore, a total hazard greater than the hazard posed by the Secretary of Labor to promulgate of 25,500 digger-derrick operators the digger-derrick activities OSHA and enforce occupational safety and would require operator certification. already exempted in the 2010 final rule. health standards (29 U.S.C. 654(b), In its FEA for the final rule, OSHA Because this direct final rule 655(b)). An occupational safety or estimated that the total costs for NAICS estimates cost savings of $21.6 million health standard is a standard that 221110 would be $6.7 million ($4 per year, this direct final rule is not ‘‘requires conditions, or the adoption or million for operator certification), and economically significant within the use of one or more practices, means, the total costs for NAICS 221120 would meaning of Executive Order 12866 (58 methods, operations, or processes, be $18.7 million annually ($8.7 million FR 51735). The rule does not impose reasonably necessary or appropriate to for operator certification) (see FEA additional costs on any private-sector or provide safe or healthful employment Table B–9 in the Aug. 9, 2010, FR public-sector entity, and does not meet and places of employment’’ (29 U.S.C. notice). Fully exempting digger derricks any of the criteria for an economically 652(8)). A standard is reasonably from the scope of the standard also significant or major rule specified by necessary or appropriate within the eliminates costs for other activities Executive Order 12866 and the relevant meaning of Section 652(8) if it besides operator certification, such as statutes. This rule is not a ‘‘major rule’’ substantially reduces or eliminates inspections and power-line safety. In under Section 804 of the Small Business significant risk (see Industrial Union the original FEA, the two main cost Regulatory Enforcement Fairness Act of Department, AFL–CIO v. American components for an industry were the 1996 (5 U.S.C. 801 et seq.). Petroleum Institute, 448 U.S. 607 number of crane operators and the OSHA developed this direct final rule (1980)). number of jobs involving cranes. The consistent with the provisions of This direct final rule does not impose original FEA estimated that digger Executive Orders 12866 and 13563. any additional requirements on derricks represented 85 percent of Accordingly, this direct final rule employers. Because OSHA previously operators, and 85 percent of jobs follows closely the principle of EO determined that the Cranes and Derricks involving cranes. OSHA, therefore, 13563 that agencies should use new in Construction standard substantially estimates that digger derricks account data developed after completion of a reduces a significant risk (see 75 FR for 85 percent of the costs attributed to rulemaking (retrospective analysis) to 47913), it is unnecessary for the Agency NAICS 221110 and NAICS 221120. determine if a regulation ‘‘should be to make additional findings on risk for Applying this 85 percent factor to the modified, streamlined, expanded, or the purposes of this minor amendment total costs for the industries yields costs repealed.’’ In this case, review of data to the digger-derrick exemption (see, for digger derricks of $5.7 million per submitted after completion of the initial e.g., Public Citizen Health Research year in NAICS 221110 and $15.9 million rulemaking provided OSHA with the Group v. Tyson, 796 F.2d 1479, 1502 per year in NAICS 221120, for a total of opportunity to streamline a rule by 3 n.16 (DC Cir. 1986) (rejecting the $21.6 million per year. dropping its application to digger argument that OSHA must ‘‘find that derricks, thereby saving the industry an 3 each and every aspect of its standard Based on the size of digger derricks and EEI’s estimated $21.6 million per year. As eliminates a significant risk’’). descriptions of digger-derrick activities, OSHA understands that the vast majority of digger-derrick B. Final Economic Analysis and Final use for construction activity in the electric-utility employers may be under that SIC code because industry will involve transmission and distribution their primary work is in that area, but those Regulatory Flexibility Act Analysis work subject to subpart V of 29 CFR 1926. employers also may engage in transmission work When it issued the final rule for Employers categorized under NAICS 221120 covered by subpart V. Because the record does not generally conduct electric-transmission and indicate that employers use digger derricks for Cranes and Derricks in Construction, -distribution work. However, OSHA is including power-generation construction activities, OSHA OSHA prepared a Final Economic digger derricks under NAICS 221110, which is the assumes that the use of digger derricks under Analysis (FEA) as required by the SIC code for power generation, because some NAICS 221110 is for subpart V work.

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described previously, this action Attn: OMB Desk Officer for OSHA, 48128 and 48129). Because the current removes duties and costs for the Office of Management and Budget, rulemaking does not impose any electric-utility industry, and does not Room 10235, 726 Jackson Place NW., additional burdens, that analysis applies impose any new duties on any Washington, DC 20503. The Agency also to the revision of the digger-derrick employer. Because small entities will encourages commenters to submit their exemption. Therefore, this direct final have reduced costs as a result of this comments on this paperwork rule complies with Executive Order direct final rule, the Agency certifies determination to OSHA, along with 13132. In states without OSHA- that the final standard would not their other comments on this direct final approved state plans, any standard impose significant economic costs on a rule, within the specified comment developed from this direct final rule substantial number of small entities. period. would impact state policy options in the OSHA notes that a federal agency same manner as every standard C. Technological Feasibility cannot conduct or sponsor a collection promulgated by OSHA. In states with A standard is technologically feasible of information unless it is approved by OSHA-approved state plans, this when the protective measures it requires the Office of Management and Budget rulemaking does not limit state policy already exist, when available technology (OMB) under the Paperwork Reduction options. can bring the protective measures into Act of 1995, 44 U.S.C. 3501 et seq. and existence, or when that technology is the agency also displays a currently F. State Plan States reasonably likely to develop (see valid OMB control number for the When federal OSHA promulgates a American Textile Mfrs. Institute v. collection of information, and that the new standard or more stringent OSHA, 452 U.S. 490, 513 (1981) (ATMI); public need not respond to a collection amendment to an existing standard, the American Iron and Steel Institute v. of information requirement unless the 27 states and U.S. territories with their OSHA, 939 F.2d 975, 980 (DC Cir. 1991) agency displays a currently valid OMB own OSHA-approved occupational (AISI)). This direct final rule does not control number. Also, notwithstanding safety and health plans must amend require any additional protective any other provisions of law, no person their standards to reflect the new measures. In the original FEA, OSHA shall be subject to a penalty for failing standard or amendment, or show OSHA found the standard to be technologically to comply with a collection of why such action is unnecessary, e.g., feasible (75 FR 48079). OSHA concludes information requirement if the because an existing state standard that this revision is feasible as well requirement does not display a covering this area is at least as effective because it reduces or removes current currently valid OMB control number. in protecting employees as the new requirements on employers. federal standard or amendment (29 CFR E. Federalism 1953.5(a)). The state standard must be at D. Paperwork Reduction Act of 1995 OSHA reviewed this direct final rule least as effective in protecting When OSHA issued the final rule on in accordance with the Executive Order employees as the final federal rule. State August 9, 2010, the Agency submitted on Federalism (Executive Order 13132 Plan States must issue the standard an Information Collection Request (ICR) (64 FR 43255 (Aug. 10, 1999))), which within six months of the promulgation to OMB titled Cranes and Derricks in requires that Federal agencies, to the date of the final federal rule. When Construction (29 CFR Part 1926 Subpart extent possible, refrain from limiting OSHA promulgates a new standard or CC). On November 1, 2010, OMB state policy options, consult with states amendment that does not impose approved the ICR under OMB Control prior to taking any actions that would additional or more stringent Number 1218–0261, with an expiration restrict state policy options, and take requirements than an existing standard, date of November 30, 2013. such actions only when clear State Plan States are not required to Subsequently, in December 2010, OSHA constitutional authority exists and the amend their standards, although OSHA discontinued the Cranes and Derricks problem is national in scope. Executive may encourage them to do so. Standard for Construction (29 CFR Order 13132 provides for preemption of The 27 states and U.S. territories with 1926.550) ICR (OMB Control Number state law only with the expressed OSHA-approved occupational safety 1218–0113) because the new ICR consent of Congress. Federal agencies and health plans are: Alaska, Arizona, superseded this ICR. In addition, OSHA must limit any such preemption to the California, Hawaii, Indiana, Iowa, retitled the new ICR to Cranes and extent possible. Kentucky, Maryland, Michigan, Derricks in Construction (29 CFR Part Under Section 18 of the OSH Act, Minnesota, Nevada, New Mexico, North 1926, Subpart CC and Subpart DD). Congress expressly provides that states Carolina, Oregon, Puerto Rico, South This direct final rule, which expands may adopt, with federal approval, a plan Carolina, Tennessee, Utah, Vermont, the digger-derrick exemption, does not for the development and enforcement of Virginia, Washington, and Wyoming. require any additional collection of occupational safety and health Connecticut, Illinois, New Jersey, New information or alter the substantive standards. The OSH Act refers to states York, and the Virgin Islands have requirements detailed in the 2010 ICR. that obtain federal approval for such a OSHA-approved State Plans that apply The only impact on the collection of plan as ‘‘State Plan States’’ (29 U.S.C. to state and local government employees information will be a reduction in the 667). Occupational safety and health only. number of entities collecting standards developed by State Plan The amendments made in this direct information. Accordingly, OSHA does States must be at least as effective in final rule do not impose any new not believe it is necessary to submit a providing safe and healthful requirements on employers. new ICR to OMB. OSHA will identify employment and places of employment Accordingly, State Plan States are not any reduction in burden hours when it as the federal standards. Subject to these required to amend their standards to renews the ICR. requirements, State Plan States are free incorporate the expanded exemption Interested parties may comment on to develop and enforce under state law specified in this direct final rule, but OSHA’s determination that this direct their own requirements for safety and they may do so if they so choose. final rule contains no additional health standards. paperwork requirements by sending OSHA previously concluded that its G. Unfunded Mandates Reform Act their written comments to the Office of promulgation of subpart CC complies When OSHA issued the final rule for Information and Regulatory Affairs, with Executive Order 13132 (75 FR Cranes and Derricks in Construction (75

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FR 48130), it reviewed the rule Signed at Washington, DC, on October 9, at § 1910.268(s)(40)) must comply with according to the Unfunded Mandates 2012. all of the provisions of § 1910.268. Reform Act of 1995 (UMRA; 2 U.S.C. David Michaels, * * * * * 1501 et seq.) and Executive Order 13132 Assistant Secretary of Labor for Occupational [FR Doc. 2012–27210 Filed 11–8–12; 8:45 am] (64 FR 43255 (Aug. 10, 1999)), and Safety and Health. BILLING CODE 4510–26–P concluded that the final rule did not Amendments to Standards meet the definition of a ‘‘Federal intergovernmental mandate’’ under the For the reasons stated in the preamble DEPARTMENT OF THE TREASURY UMRA. OSHA’s standards do not apply of this direct final rule, OSHA is to state or local governments except in amending 29 CFR part 1926 as follows: Office of Foreign Assets Control states that have voluntarily adopted PART 1926—[AMENDED] 31 CFR Part 552 state plans. OSHA further noted that the rule imposed costs of over $100 million Subpart V—Power Transmission and Yemen Sanctions Regulations per year on the private sector and, Distribution. therefore, required review under the AGENCY: Office of Foreign Assets UMRA for those costs; the Agency ■ 1. Revise the authority citation for Control, Treasury. determined that its Final Economic subpart V to read as follows: ACTION: Final rule. Analysis met that requirement. Id. Authority: 40 U.S.C. 3701; 29 U.S.C. 653, SUMMARY: The Department of the As discussed above in Section IV.B. 655, 657; Secretary of Labor’s Order Nos. 12– Treasury’s Office of Foreign Assets 71 (36 FR 8754); 8–76 (41 FR 25059); 9–83 (Final Economic Analysis and Final (48 FR 35736), 1–90 (55 FR 9033), 5–2007 (72 Control (‘‘OFAC’’) is issuing regulations Regulatory Flexibility Act Analysis) of FR 31159), or 1–2012 (77 FR 3912), as to implement Executive Order 13611 of this preamble, this direct final rule applicable. Section 1926.951 also is issued May 16, 2012 (‘‘Blocking Property of reduces expenditures by private-sector under 29 CFR part 1911. Persons Threatening the Peace, Security, employers. For the purposes of the ■ 2. Amend § 1926.952 by revising or Stability of Yemen’’). OFAC intends UMRA, OSHA certifies that this direct paragraph (c)(2) to read as follows: to supplement this part 552 with a more final rule does not mandate that state, comprehensive set of regulations, which local, or tribal governments adopt new, § 1926.952 Mechanical equipment. may include additional interpretive and unfunded regulatory obligations, or * * * * * definitional guidance and additional increase expenditures by the private (c). * * * general licenses and statements of sector of more than $100 million in any (2) Use of digger derricks must licensing policy. year. comply with § 1910.269 (in addition to DATES: Effective Date: November 9, 29 CFR 1926, subpart O) whenever such 2012. H. Consultation and Coordination With use is excluded from 29 CFR 1926, FOR FURTHER INFORMATION CONTACT: Indian Tribal Governments subpart CC, in accordance with Assistant Director for Sanctions OSHA reviewed this direct final rule § 1926.1400(c)(4). Compliance & Evaluation, tel.: 202/622– in accordance with Executive Order * * * * * 2490, Assistant Director for Licensing, 13175 (65 FR 67249 (Nov. 9, 2000)), and tel.: 202/622–2480, Assistant Director Subpart CC—Cranes and Derricks in determined that it does not have ‘‘tribal for Policy, tel.: 202/622–4855, Office of Construction. Foreign Assets Control, or Chief Counsel implications’’ as defined in that order. (Foreign Assets Control), tel.: 202/622– This direct final rule does not have ■ 3. Revise the authority citation for 2410, Office of the General Counsel, substantial direct effects on one or more subpart CC to read as follows: Department of the Treasury (not toll free Indian tribes, on the relationship numbers). between the federal government and Authority: 40 U.S.C. 3701; 29 U.S.C. 653, 655, 657; and Secretary of Labor’s Order No. SUPPLEMENTARY INFORMATION: Indian tribes, or on the distribution of 5–2007 (72 FR 31159) or 1–2012 (77 FR power and responsibilities between the 3912), as applicable; and 29 CFR part 1911. Electronic and Facsimile Availability federal government and Indian tribes. This document and additional ■ 4. Amend § 1926.1400 by revising List of Subjects in 29 CFR Part 1926 information concerning OFAC are paragraph (c)(4) to read as follows: available from OFAC’s Web site Cranes and derricks, Construction § 1926.1400 Scope. (www.treasury.gov/ofac). Certain general information pertaining to OFAC’s industry, Occupational safety and * * * * * health. sanctions programs also is available via (c) * * * facsimile through a 24-hour fax-on- Authority and Signature (4) Digger derricks when used for demand service, tel.: 202/622–0077. augering holes for poles carrying electric David Michaels, Ph.D., MPH, or telecommunication lines, placing and Background Assistant Secretary of Labor for removing the poles, and for handling On May 16, 2012, the President issued Occupational Safety and Health, U.S. associated materials for installation on, Executive Order 13611 (77 FR 29533, Department of Labor, 200 Constitution or removal from, the poles, or when May 18, 2012) (‘‘E.O. 13611’’), invoking Ave. NW., Washington, DC 20210, used for any other work subject to the authority of, inter alia, the authorized the preparation of this subpart V of this part. To be eligible for International Emergency Economic notice. OSHA is issuing this direct final this exclusion, digger-derrick use in Powers Act (50 U.S.C. 1701 et seq.) and rule under the following authorities: 29 work subject to subpart V of this part the National Emergencies Act (50 U.S.C. U.S.C. 653, 655, 657; 40 U.S.C. 3701 et must comply with all of the provisions 1601 et seq.). seq.; 5 U.S.C. 553; Secretary of Labor’s of that subpart, and digger-derrick use The Department of the Treasury’s Order No. 1–2012 (77 FR 3912, Jan. 25, in construction work for Office of Foreign Assets Control 2012); and 29 CFR part 1911. telecommunication service (as defined (‘‘OFAC’’) is issuing the Yemen

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Sanctions Regulations, 31 CFR part 552 Subpart B—Prohibitions chapter, with the exception of part 501 (the ‘‘Regulations’’), to implement E.O. 552.201 Prohibited transactions. of this chapter, the recordkeeping and 13611, pursuant to authorities delegated 552.202 Effect of transfers violating the reporting requirements and license to the Secretary of the Treasury in E.O. provisions of this part. application and other procedures of 13611. A copy of E.O. 13611 appears in 552.203 Holding of funds in interest- which apply to this part. Actions taken Appendix A to this part. bearing accounts; investment and pursuant to part 501 of this chapter with reinvestment. The Regulations are being published respect to the prohibitions contained in in abbreviated form at this time for the Subpart C—General Definitions this part are considered actions taken purpose of providing immediate 552.301 Blocked account; blocked pursuant to this part. Differing foreign guidance to the public. OFAC intends to property. policy and national security supplement this part 552 with a more 552.302 Effective date. circumstances may result in differing comprehensive set of regulations, which 552.303 Entity. interpretations of similar language may include additional interpretive and 552.304 Interest. among the parts of this chapter. No definitional guidance and additional 552.305 Licenses; general and specific. license or authorization contained in or 552.306 Person. general licenses and statements of issued pursuant to those other parts licensing policy. The appendix to the 552.307 Property; property interest. 552.308 Transfer. authorizes any transaction prohibited by Regulations will be removed when 552.309 United States. this part. No license or authorization OFAC supplements this part with a 552.310 U.S. financial institution. contained in or issued pursuant to any more comprehensive set of regulations. 552.311 United States person; U.S. person. other provision of law or regulation Public Participation Subpart D—Interpretations authorizes any transaction prohibited by this part. No license or authorization § 552.401 [Reserved] Because the Regulations involve a contained in or issued pursuant to this foreign affairs function, the provisions 552.402 Effect of amendment. part relieves the involved parties from of Executive Order 12866 of September 552.403 Termination and acquisition of an complying with any other applicable 30, 1993, and the Administrative interest in blocked property. 552.404 Transactions ordinarily incident to laws or regulations. Procedure Act (5 U.S.C. 553) requiring a licensed transaction. notice of proposed rulemaking, Note to § 552.101: This part has been 552.405 Setoffs prohibited. published in abbreviated form for the opportunity for public participation, 552.406 Entities owned by a person whose and delay in effective date are purpose of providing immediate guidance to property and interests in property are the public. OFAC intends to supplement this inapplicable. Because no notice of blocked. part with a more comprehensive set of proposed rulemaking is required for this Subpart E—Licenses, Authorizations, and regulations, which may include additional rule, the Regulatory Flexibility Act (5 Statements of Licensing Policy interpretive and definitional guidance and U.S.C. 601–612) does not apply. additional general licenses and statements of 552.501 General and specific licensing licensing policy. Paperwork Reduction Act procedures. 552.502 [Reserved] The collections of information related 552.503 Exclusion from licenses. Subpart B—Prohibitions to the Regulations are contained in 31 552.504 Payments and transfers to blocked CFR part 501 (the ‘‘Reporting, accounts in U.S. financial institutions. § 552.201 Prohibited transactions. Procedures and Penalties Regulations’’). 552.505 Entries in certain accounts for All transactions prohibited pursuant Pursuant to the Paperwork Reduction normal service charges authorized. to Executive Order 13611 of May 16, Act of 1995 (44 U.S.C. 3507), those 552.506 Provision of certain legal services 2012, are also prohibited pursuant to collections of information have been authorized. this part. approved by the Office of Management 552.507 Authorization of emergency medical services. Note 1 to § 552.201: The names of persons and Budget under control number 1505– designated pursuant to Executive Order 0164. An agency may not conduct or Subpart F—[Reserved] 13611, whose property and interests in sponsor, and a person is not required to Subpart G—[Reserved] property therefore are blocked pursuant to respond to, a collection of information this section, are published in the Federal unless the collection of information Subpart H—Procedures Register and incorporated into the Office of displays a valid control number. 552.801 [Reserved] Foreign Assets Control’s Specially 552.802 Delegation by the Secretary of the Designated Nationals and Blocked Persons List of Subjects in 31 CFR Part 552 Treasury. List (‘‘SDN List’’) with the identifier ‘‘[YEMEN].’’ The SDN List is accessible Administrative practice and Subpart I—Paperwork Reduction Act through the following page on the Office of procedure, Banking, Banks, Blocking of 552.901 Paperwork Reduction Act notice. Foreign Assets Control’s Web site: assets, Brokers, Credit, Foreign Trade, www.treasury.gov/sdn. Additional Investments, Loans, Securities, Services, APPENDIX A TO PART 552—Executive information pertaining to the SDN List can be Yemen. Order 13611 of May 16, 2012 found in Appendix A to this chapter. See For the reasons set forth in the § 552.406 concerning entities that may not be Authority: 3 U.S.C. 301; 31 U.S.C. 321(b); listed on the SDN List but whose property preamble, the Department of the 50 U.S.C. 1601–1651, 1701–1706; Pub. L. Treasury’s Office of Foreign Assets and interests in property are nevertheless 101–410, 104 Stat. 890 (28 U.S.C. 2461 note); blocked pursuant to this section. Control adds part 552 to 31 CFR chapter Pub. L. 110–96, 121 Stat. 1011 (50 U.S.C. V to read as follows: 1705 note); E.O. 13611, 77 FR 29533, May 18, Note 2 to § 552.201: The International 2012. Emergency Economic Powers Act (50 U.S.C. PART 552—YEMEN SANCTIONS 1701–1706), in Section 203 (50 U.S.C. 1702), REGULATIONS Subpart A—Relation of This Part to authorizes the blocking of property and Other Laws and Regulations interests in property of a person during the Subpart A—Relation of This Part to Other pendency of an investigation. The names of Laws and Regulations § 552.101 Relation of this part to other persons whose property and interests in Sec. laws and regulations. property are blocked pending investigation 552.101 Relation of this part to other laws This part is separate from, and pursuant to this section also are published in and regulations. independent of, the other parts of this the Federal Register and incorporated into

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the SDN List with the identifier ‘‘[BPI– did not have reasonable cause to know (ii) With a broker or dealer registered YEMEN].’’ or suspect, in view of all the facts and with the Securities and Exchange circumstances known or available to Commission under the Securities Note 3 to § 552.201: Sections 501.806 and 501.807 of this chapter describe the such person, that such transfer required Exchange Act of 1934 (15 U.S.C. 78a et procedures to be followed by persons a license or authorization issued seq.), provided the funds are invested in seeking, respectively, the unblocking of pursuant to this part and was not so a money market fund or in U.S. funds that they believe were blocked due to licensed or authorized, or, if a license or Treasury bills. mistaken identity, or administrative authorization did purport to cover the (2) Funds held or placed in a blocked reconsideration of their status as persons transfer, that such license or account pursuant to paragraph (a) of this whose property and interests in property are authorization had been obtained by section may not be invested in blocked pursuant to this section. misrepresentation of a third party or instruments the maturity of which withholding of material facts or was exceeds 180 days. § 552.202 Effect of transfers violating the otherwise fraudulently obtained; and (c) For purposes of this section, a rate provisions of this part. (3) The person with whom such is commercially reasonable if it is the (a) Any transfer after the effective date property is or was held or maintained rate currently offered to other depositors that is in violation of any provision of filed with the Office of Foreign Assets on deposits or instruments of this part or of any regulation, order, Control a report setting forth in full the comparable size and maturity. directive, ruling, instruction, or license circumstances relating to such transfer (d) For purposes of this section, if issued pursuant to this part, and that promptly upon discovery that: interest is credited to a separate blocked involves any property or interest in (i) Such transfer was in violation of account or subaccount, the name of the property blocked pursuant to § 552.201, the provisions of this part or any account party on each account must be is null and void and shall not be the regulation, ruling, instruction, license, the same. basis for the assertion or recognition of or other directive or authorization (e) Blocked funds held in instruments any interest in or right, remedy, power, issued pursuant to this part; the maturity of which exceeds 180 days or privilege with respect to such (ii) Such transfer was not licensed or at the time the funds become subject to property or property interests. authorized by the Office of Foreign § 552.201 may continue to be held until (b) No transfer before the effective maturity in the original instrument, date shall be the basis for the assertion Assets Control; or (iii) If a license did purport to cover provided any interest, earnings, or other or recognition of any right, remedy, proceeds derived therefrom are paid power, or privilege with respect to, or the transfer, such license had been obtained by misrepresentation of a third into a blocked interest-bearing account any interest in, any property or interest in accordance with paragraphs (a) or (f) in property blocked pursuant to party or withholding of material facts or was otherwise fraudulently obtained. of this section. § 552.201, unless the person who holds (f) Blocked funds held in accounts or or maintains such property, prior to that Note to paragraph (d) of § 552.202: The instruments outside the United States at date, had written notice of the transfer filing of a report in accordance with the the time the funds become subject to or by any written evidence had provisions of paragraph (d)(3) of this section shall not be deemed evidence that the terms § 552.201 may continue to be held in the recognized such transfer. same type of accounts or instruments, (c) Unless otherwise provided, an of paragraphs (d)(1) and (d)(2) of this section have been satisfied. provided the funds earn interest at rates appropriate license or other that are commercially reasonable. authorization issued by the Office of (e) Unless licensed pursuant to this (g) This section does not create an Foreign Assets Control before, during, or part, any attachment, judgment, decree, affirmative obligation for the holder of after a transfer shall validate such lien, execution, garnishment, or other blocked tangible property, such as transfer or make it enforceable to the judicial process is null and void with chattels or real estate, or of other same extent that it would be valid or respect to any property in which, on or blocked property, such as debt or equity enforceable but for the provisions of the since the effective date, there existed an securities, to sell or liquidate such International Emergency Economic interest of a person whose property and property. However, the Office of Foreign Powers Act, Executive Order 13611, this interests in property are blocked Assets Control may issue licenses part, and any regulation, order, pursuant to § 552.201. permitting or directing such sales or directive, ruling, instruction, or license § 552.203 Holding of funds in interest- liquidation in appropriate cases. issued pursuant to this part. (h) Funds subject to this section may (d) Transfers of property that bearing accounts; investment and reinvestment. not be held, invested, or reinvested in otherwise would be null and void or a manner that provides immediate unenforceable by virtue of the (a) Except as provided in paragraphs (e) or (f) of this section, or as otherwise financial or economic benefit or access provisions of this section shall not be to any person whose property and deemed to be null and void or directed by the Office of Foreign Assets Control, any U.S. person holding funds, interests in property are blocked unenforceable as to any person with pursuant to § 552.201, nor may their whom such property is or was held or such as currency, bank deposits, or liquidated financial obligations, subject holder cooperate in or facilitate the maintained (and as to such person only) pledging or other attempted use as in cases in which such person is able to to § 552.201 shall hold or place such funds in a blocked interest-bearing collateral of blocked funds or other establish to the satisfaction of the Office assets. of Foreign Assets Control each of the account located in the United States. following: (b)(1) For purposes of this section, the Subpart C—General Definitions (1) Such transfer did not represent a term blocked interest-bearing account willful violation of the provisions of this means a blocked account: § 552.301 Blocked account; blocked part by the person with whom such (i) In a federally-insured U.S. bank, property. property is or was held or maintained thrift institution, or credit union, The terms blocked account and (and as to such person only); provided the funds are earning interest blocked property shall mean any (2) The person with whom such at rates that are commercially account or property subject to the property is or was held or maintained reasonable; or prohibitions in § 552.201 held in the

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name of a person whose property and guarantees, debentures, stocks, bonds, § 552.309 United States. interests in property are blocked coupons, any other financial The term United States means the pursuant to § 552.201, or in which such instruments, bankers acceptances, United States, its territories and person has an interest, and with respect mortgages, pledges, liens or other rights possessions, and all areas under the to which payments, transfers, in the nature of security, warehouse jurisdiction or authority thereof. exportations, withdrawals, or other receipts, bills of lading, trust receipts, dealings may not be made or effected bills of sale, any other evidences of title, § 552.310 U.S. financial institution. except pursuant to an authorization or ownership or indebtedness, letters of license from the Office of Foreign Assets credit and any documents relating to The term U.S. financial institution Control expressly authorizing such any rights or obligations thereunder, means any U.S. entity (including its action. powers of attorney, goods, wares, foreign branches) that is engaged in the merchandise, chattels, stocks on hand, business of accepting deposits, making, Note to § 552.301: See § 552.406 granting, transferring, holding, or concerning the blocked status of property ships, goods on ships, real estate mortgages, deeds of trust, vendors’ sales brokering loans or credits, or purchasing and interests in property of an entity that is or selling foreign exchange, securities, 50 percent or more owned by a person whose agreements, land contracts, leaseholds, property and interests in property are ground rents, real estate and any other or commodity futures or options, or blocked pursuant to § 552.201. interest therein, options, negotiable procuring purchasers and sellers instruments, trade acceptances, thereof, as principal or agent. It includes § 552.302 Effective date. royalties, book accounts, accounts but is not limited to depository The term effective date refers to the payable, judgments, patents, trademarks institutions, banks, savings banks, trust effective date of the applicable or copyrights, insurance policies, safe companies, securities brokers and prohibitions and directives contained in deposit boxes and their contents, dealers, commodity futures and options this part, and, with respect to a person annuities, pooling agreements, services brokers and dealers, forward contract whose property and interests in of any nature whatsoever, contracts of and foreign exchange merchants, property are blocked pursuant to any nature whatsoever, and any other securities and commodities exchanges, § 552.201, is the earlier of the date of property, real, personal, or mixed, clearing corporations, investment actual or constructive notice that such tangible or intangible, or interest or companies, employee benefit plans, and person’s property and interests in interests therein, present, future, or U.S. holding companies, U.S. affiliates, property are blocked. contingent. or U.S. subsidiaries of any of the foregoing. This term includes those § 552.303 Entity. § 552.308 Transfer. branches, offices, and agencies of The term entity means a partnership, foreign financial institutions that are The term transfer means any actual or association, trust, joint venture, located in the United States, but not purported act or transaction, whether or corporation, group, subgroup, or other such institutions’ foreign branches, not evidenced by writing, and whether organization. offices, or agencies. or not done or performed within the § 552.304 Interest. United States, the purpose, intent, or § 552.311 United States person; U.S. Except as otherwise provided in this effect of which is to create, surrender, person. part, the term interest, when used with release, convey, transfer, or alter, The term United States person or U.S. respect to property (e.g., ‘‘an interest in directly or indirectly, any right, remedy, person means any United States citizen, property’’), means an interest of any power, privilege, or interest with respect permanent resident alien, entity nature whatsoever, direct or indirect. to any property. Without limitation on organized under the laws of the United the foregoing, it shall include the § 552.305 Licenses; general and specific. States or any jurisdiction within the making, execution, or delivery of any United States (including foreign (a) Except as otherwise specified, the assignment, power, conveyance, check, branches), or any person in the United term license means any license or declaration, deed, deed of trust, power States. authorization contained in or issued of attorney, power of appointment, bill pursuant to this part. of sale, mortgage, receipt, agreement, Subpart D—Interpretations (b) The term general license means contract, certificate, gift, sale, affidavit, any license or authorization the terms of or statement; the making of any § 552.401 [Reserved] which are set forth in subpart E of this payment; the setting off of any § 552.402 Effect of amendment. part. obligation or credit; the appointment of (c) The term specific license means any agent, trustee, or fiduciary; the Unless otherwise specifically any license or authorization not set forth creation or transfer of any lien; the provided, any amendment, in subpart E of this part but issued issuance, docketing, or filing of, or levy modification, or revocation of any pursuant to this part. of or under, any judgment, decree, provision in or appendix to this part or Note to § 552.305: See § 501.801 of this attachment, injunction, execution, or chapter or of any order, regulation, chapter on licensing procedures. other judicial or administrative process ruling, instruction, or license issued by or order, or the service of any the Office of Foreign Assets Control § 552.306 Person. garnishment; the acquisition of any does not affect any act done or omitted, The term person means an individual interest of any nature whatsoever by or any civil or criminal proceeding or entity. reason of a judgment or decree of any commenced or pending, prior to such foreign country; the fulfillment of any amendment, modification, or § 552.307 Property; property interest. condition; the exercise of any power of revocation. All penalties, forfeitures, The terms property and property appointment, power of attorney, or and liabilities under any such order, interest include, but are not limited to, other power; or the acquisition, regulation, ruling, instruction, or license money, checks, drafts, bullion, bank disposition, transportation, importation, continue and may be enforced as if such deposits, savings accounts, debts, exportation, or withdrawal of any amendment, modification, or revocation indebtedness, obligations, notes, security. had not been made.

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§ 552.403 Termination and acquisition of Subpart E—Licenses, Authorizations, service charges owed it by the owner of an interest in blocked property. and Statements of Licensing Policy that blocked account. (a) Whenever a transaction licensed or (b) As used in this section, the term § 552.501 General and specific licensing normal service charges shall include authorized by or pursuant to this part procedures. results in the transfer of property charges in payment or reimbursement (including any property interest) away For provisions relating to licensing for interest due; cable, telegraph, from a person, such property shall no procedures, see part 501, subpart E of internet, or telephone charges; postage longer be deemed to be property this chapter. Licensing actions taken costs; custody fees; small adjustment blocked pursuant to § 552.201, unless pursuant to part 501 of this chapter with charges to correct bookkeeping errors; there exists in the property another respect to the prohibitions contained in and, but not by way of limitation, interest that is blocked pursuant to this part are considered actions taken minimum balance charges, notary and § 552.201, the transfer of which has not pursuant to this part. General licenses protest fees, and charges for reference been effected pursuant to license or and statements of licensing policy books, photocopies, credit reports, other authorization. relating to this part also may be transcripts of statements, registered (b) Unless otherwise specifically available through the Yemen sanctions mail, insurance, stationery and supplies, provided in a license or authorization page on OFAC’s Web site: and other similar items. www.treasury.gov/ofac. issued pursuant to this part, if property § 552.506 Provision of certain legal (including any property interest) is § 552.502 [Reserved] services authorized. transferred or attempted to be (a) The provision of the following § 552.503 Exclusion from licenses. transferred to a person whose property legal services to or on behalf of persons and interests in property are blocked The Office of Foreign Assets Control whose property and interests in pursuant to § 552.201, such property reserves the right to exclude any person, property are blocked pursuant to shall be deemed to be property in which property, transaction, or class thereof § 552.201 is authorized, provided that that person has an interest and therefore from the operation of any license or all receipts of payment of professional blocked. from the privileges conferred by any fees and reimbursement of incurred § 552.404 Transactions ordinarily incident license. The Office of Foreign Assets expenses must be specifically licensed: to a licensed transaction. Control also reserves the right to restrict (1) Provision of legal advice and the applicability of any license to counseling on the requirements of and Any transaction ordinarily incident to particular persons, property, compliance with the laws of the United a licensed transaction and necessary to transactions, or classes thereof. Such States or any jurisdiction within the give effect thereto is also authorized, actions are binding upon actual or United States, provided that such advice except: constructive notice of the exclusions or and counseling are not provided to (a) An ordinarily incident transaction, restrictions. facilitate transactions in violation of this not explicitly authorized within the part; terms of the license, by or with a person § 552.504 Payments and transfers to (2) Representation of persons named whose property and interests in blocked accounts in U.S. financial institutions. as defendants in or otherwise made property are blocked pursuant to parties to domestic U.S. legal, § 552.201; or Any payment of funds or transfer of arbitration, or administrative (b) An ordinarily incident transaction, credit in which a person whose property proceedings; not explicitly authorized within the and interests in property are blocked (3) Initiation and conduct of legal, terms of the license, involving a debit to pursuant to § 552.201 has any interest arbitration, or administrative a blocked account or a transfer of that comes within the possession or proceedings before any U.S. federal, blocked property. control of a U.S. financial institution state, or local court or agency; must be blocked in an account on the (4) Representation of persons before § 552.405 Setoffs prohibited. books of that financial institution. A any U.S. federal, state, or local court or A setoff against blocked property transfer of funds or credit by a U.S. agency with respect to the imposition, (including a blocked account), whether financial institution between blocked administration, or enforcement of U.S. by a U.S. bank or other U.S. person, is accounts in its branches or offices is sanctions against such persons; and a prohibited transfer under § 552.201 if authorized, provided that no transfer is (5) Provision of legal services in any effected after the effective date. made from an account within the other context in which prevailing U.S. United States to an account held outside law requires access to legal counsel at § 552.406 Entities owned by a person the United States, and further provided public expense. whose property and interests in property that a transfer from a blocked account (b) The provision of any other legal are blocked. may be made only to another blocked services to persons whose property and A person whose property and account held in the same name. interests in property are blocked interests in property are blocked Note to § 552.504: See § 501.603 of this pursuant to § 552.201, not otherwise pursuant to § 552.201 has an interest in chapter for mandatory reporting authorized in this part, requires the all property and interests in property of requirements regarding financial transfers. issuance of a specific license. an entity in which it owns, directly or See also § 552.203 concerning the obligation (c) Entry into a settlement agreement indirectly, a 50 percent or greater to hold blocked funds in interest-bearing or the enforcement of any lien, interest. The property and interests in accounts. judgment, arbitral award, decree, or property of such an entity, therefore, are other order through execution, blocked, and such an entity is a person § 552.505 Entries in certain accounts for garnishment, or other judicial process whose property and interests in normal service charges authorized. purporting to transfer or otherwise alter property are blocked pursuant to (a) A U.S. financial institution is or affect property or interests in § 552.201, regardless of whether the authorized to debit any blocked account property blocked pursuant to § 552.201 entity itself is designated pursuant to held at that financial institution in is prohibited unless licensed pursuant Executive Order 13611. payment or reimbursement for normal to this part.

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§ 552.507 Authorization of emergency of Yemen and those in opposition to it, the official business of the United States medical services. which provides for a peaceful transition of Government by employees, grantees, or The provision of nonscheduled power that meets the legitimate demands and contractors thereof. emergency medical services in the aspirations of the Yemeni people for change, Sec. 6. (a) Any transaction that evades or United States to persons whose property and by obstructing the political process in avoids, has the purpose of evading or Yemen. I further find that these actions avoiding, causes a violation of, or attempts to and interests in property are blocked constitute an unusual and extraordinary violate any of the prohibitions set forth in pursuant to § 552.201 is authorized, threat to the national security and foreign this order is prohibited. provided that all receipt of payment for policy of the United States, and I hereby such services must be specifically declare a national emergency to deal with (b) Any conspiracy formed to violate any licensed. that threat. I hereby order: of the prohibitions set forth in this order is Section 1. All property and interests in prohibited. Subpart F—[Reserved] property that are in the United States, that Sec. 7. For the purposes of this order: hereafter come within the United States, or (a) the term ‘‘person’’ means an individual Subpart G—[Reserved] that are or hereafter come within the or entity; possession or control of any United States (b) the term ‘‘entity’’ means a partnership, person, including any foreign branch, of the Subpart H—Procedures association, trust, joint venture, corporation, following persons are blocked and may not group, subgroup, or other organization; and § 552.801 [Reserved] be transferred, paid, exported, withdrawn, or (c) the term ‘‘United States person’’ means otherwise dealt in: any person determined by any United States citizen, permanent resident the Secretary of the Treasury, in consultation § 552.802 Delegation by the Secretary of alien, entity organized under the laws of the with the Secretary of State, to: the Treasury. United States or any jurisdiction within the Any action that the Secretary of the (a) have engaged in acts that directly or indirectly threaten the peace, security, or United States (including foreign branches), or Treasury is authorized to take pursuant stability of Yemen, such as acts that obstruct any person in the United States. to Executive Order 13611 of May 16, the implementation of the agreement of Sec. 8. For those persons whose property 2012 (77 FR 29533, May 18, 2012), and November 23, 2011, between the Government and interests in property are blocked any further Executive orders relating to of Yemen and those in opposition to it, pursuant to this order who might have a the national emergency declared which provides for a peaceful transition of constitutional presence in the United States, therein, may be taken by the Director of power in Yemen, or that obstruct the political I find that because of the ability to transfer the Office of Foreign Assets Control or process in Yemen; funds or other assets instantaneously, prior by any other person to whom the (b) be a political or military leader of an notice to such persons of measures to be Secretary of the Treasury has delegated entity that has engaged in the acts described taken pursuant to this order would render in subsection (a) of this section; authority so to act. those measures ineffectual. I therefore (c) have materially assisted, sponsored, or determine that for these measures to be Subpart I—Paperwork Reduction Act provided financial, material, or technological effective in addressing the national support for, or goods or services to or in emergency declared in this order, there need § 552.901 Paperwork Reduction Act notice. support of, the acts described in subsection (a) of this section or any person whose be no prior notice of a listing or For approval by the Office of property and interests in property are determination made pursuant to section 1 of Management and Budget (‘‘OMB’’) blocked pursuant to this order; or this order. under the Paperwork Reduction Act of (d) be owned or controlled by, or to have Sec. 9. The Secretary of the Treasury, in 1995 (44 U.S.C. 3507) of information acted or purported to act for or on behalf of, consultation with the Secretary of State, is collections relating to recordkeeping directly or indirectly, any person whose hereby authorized to take such actions, and reporting requirements, licensing property and interests in property are including the promulgation of rules and procedures (including those pursuant to blocked pursuant to this order. regulations, and to employ all powers statements of licensing policy), and Sec. 2. I hereby determine that the making granted to the President by IEEPA as may be other procedures, see § 501.901 of this of donations of the type of articles specified necessary to carry out the purposes of this in section 203(b)(2) of IEEPA (50 U.S.C. chapter. An agency may not conduct or order. The Secretary of the Treasury may 1702(b)(2)) by, to, or for the benefit of any redelegate any of these functions to other sponsor, and a person is not required to person whose property and interests in respond to, a collection of information officers and agencies of the United States property are blocked pursuant to section 1 of Government consistent with applicable law. unless it displays a valid control this order would seriously impair my ability All agencies of the United States Government number assigned by OMB. to deal with the national emergency declared in this order, and I hereby prohibit such are hereby directed to take all appropriate Appendix A to Part 552—Executive donations as provided by section 1 of this measures within their authority to carry out Order 13611 order. the provisions of this order. Sec. 10. The Secretary of the Treasury, in Executive Order 13611 of May 16, 2012 Sec. 3. The prohibitions in section 1 of this order include but are not limited to: consultation with the Secretary of State, is Blocking Property of Persons Threatening the (a) the making of any contribution or hereby authorized to submit the recurring Peace, Security, or Stability of Yemen provision of funds, goods, or services by, to, and final reports to the Congress on the By the authority vested in me as President or for the benefit of any person whose national emergency declared in this order, by the Constitution and the laws of the property and interests in property are consistent with section 401(c) of the NEA (50 United States of America, including the blocked pursuant to this order; and U.S.C. 1641(c)) and section 204(c) of IEEPA International Emergency Economic Powers (b) the receipt of any contribution or (50 U.S.C. 1703(c)). Act (50 U.S.C. 1701 et seq.) (IEEPA), the provision of funds, goods, or services from Sec. 11. This order is not intended to, and National Emergencies Act (50 U.S.C. 1601 et any such person. does not, create any right or benefit, seq.) (NEA), and section 301 of title 3, United Sec. 4. The prohibitions in section 1 of this substantive or procedural, enforceable at law States Code, I, BARACK OBAMA, President order apply except to the extent provided by or in equity by any party against the United statutes, or in regulations, orders, directives, of the United States of America, find that the States, its departments, agencies, or entities, actions and policies of certain members of or licenses that may be issued pursuant to its officers, employees, or agents, or any other the Government of Yemen and others this order, and notwithstanding any contract threaten Yemen’s peace, security, and entered into or any license or permit granted person. stability, including by obstructing the prior to the effective date of this order. Barack Obama implementation of the agreement of Sec. 5. Nothing in section 1 of this order THE WHITE HOUSE, November 23, 2011, between the Government shall prohibit transactions for the conduct of May 16, 2012.

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Dated: November 2, 2012. Docket is (703) 305–5805. Please review In addition to filing an objection or Adam J. Szubin, the visitor instructions and additional hearing request with the Hearing Clerk Director, Office of Foreign Assets Control. information about the docket available as described in 40 CFR part 178, please Approved: November 2, 2012. at http://www.epa.gov/dockets. submit a copy of the filing (excluding David S. Cohen, FOR FURTHER INFORMATION CONTACT: any Confidential Business Information (CBI)) for inclusion in the public docket. Under Secretary, Office of Terrorism and Andrea Conrath, Registration Division Financial Intelligence, Department of the (7505P), Office of Pesticide Programs, Information not marked confidential Treasury. Environmental Protection Agency, 1200 pursuant to 40 CFR part 2 may be [FR Doc. 2012–27352 Filed 11–8–12; 8:45 am] Pennsylvania Ave. NW., Washington, disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your BILLING CODE 4810–AL–P DC 20460–0001; telephone number: (703) 308–9356; email address: objection or hearing request, identified [email protected]. by docket ID number EPA–HQ–OPP– 2012–0755, by one of the following ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: methods: AGENCY • I. General Information Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online 40 CFR Part 180 A. Does this action apply to me? instructions for submitting comments. [EPA–HQ–OPP–2012–0755; FRL–9366–3] You may be potentially affected by Do not submit electronically any this action if you are an agricultural information you consider to be CBI or Dinotefuran; Pesticide Tolerances for other information whose disclosure is Emergency Exemptions producer, food manufacturer, or pesticide manufacturer. The following restricted by statute. • Mail: OPP Docket, Environmental AGENCY: Environmental Protection list of North American Industrial Protection Agency Docket Center (EPA/ Agency (EPA). Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. not intended to be exhaustive, but rather ACTION: Final rule. NW., Washington, DC 20460–0001. provides a guide to help readers • Hand Delivery: To make special SUMMARY: This regulation establishes determine whether this document time-limited tolerances for residues of arrangements for hand delivery or applies to them. Potentially affected delivery of boxed information, please dinotefuran in or on pome fruits and entities may include: stone fruits. This action is in response • follow the instructions at http://www. Crop production (NAICS code 111). epa.gov/dockets/contacts.htm. to EPA’s granting of emergency • Animal production (NAICS code Additional instructions on exemptions under the Federal 112). Insecticide, Fungicide, and Rodenticide commenting or visiting the docket, • Food manufacturing (NAICS code along with more information about Act (FIFRA) authorizing use of the 311). pesticide on pome fruits and stone dockets generally, is available at • Pesticide manufacturing (NAICS http://www.epa.gov/dockets. fruits. This regulation establishes a code 32532). maximum permissible level for residues II. Background and Statutory Findings B. How can I get electronic access to of dinotefuran in or on these EPA, on its own initiative, in other related information? commodities. The time-limited accordance with FFDCA sections 408(e) tolerances expire on December 31, 2015. You may access a frequently updated and 408(l)(6), 21 U.S.C. 346a(e) and This regulation also makes the electronic version of 40 CFR part 180 346a(1)(6), is establishing time-limited systematic chemical name for through the Government Printing tolerances for combined residues of dinotefuran consistent within the Office’s e-CFR site at http:// dinotefuran, (RS)-1-methyl-2-nitro-3- section and with EPA’s policy on ecfr.gpoaccess.gov/cgi/t/text/text- ((tetrahydro-3- chemical nomenclature. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ furanyl)methyl)guanidine, including its DATES: This regulation is effective 40tab_02.tpl. metabolites and degradates, in or on November 9, 2012. Objections and pome fruits and stone fruits at 1.0 part C. How can I file an objection or hearing requests for hearings must be received per million (ppm). These time-limited request? on or before January 8, 2013, and must tolerances expire on December 31, 2015. be filed in accordance with the Under section 408(g) of the Federal Section 408(l)(6) of FFDCA requires instructions provided in 40 CFR part Food, Drug, and Cosmetic Act (FFDCA), EPA to establish a time-limited 178 (see also Unit I.C. of the 21 U.S.C. 346a, any person may file an tolerance or exemption from the SUPPLEMENTARY INFORMATION). objection to any aspect of this regulation requirement for a tolerance for pesticide ADDRESSES: The docket for this action, and may also request a hearing on those chemical residues in food that will identified by docket identification (ID) objections. You must file your objection result from the use of a pesticide under number EPA–HQ–OPP–2012–0755, is or request a hearing on this regulation an emergency exemption granted by available at http://www.regulations.gov in accordance with the instructions EPA under FIFRA section 18. Such or at the Office of Pesticide Programs provided in 40 CFR part 178. To ensure tolerances can be established without Regulatory Public Docket (OPP Docket) proper receipt by EPA, you must providing notice or period for public in the Environmental Protection Agency identify docket ID number EPA–HQ– comment. EPA does not intend for its Docket Center (EPA/DC), EPA West OPP–2012–0755 in the subject line on actions on FIFRA section 18 related Bldg., Rm. 3334, 1301 Constitution Ave. the first page of your submission. All time-limited tolerances to set binding NW., Washington, DC 20460–0001. The objections and requests for a hearing precedents for the application of FFDCA Public Reading Room is open from 8:30 must be in writing, and must be section 408 and the safety standard to a.m. to 4:30 p.m., Monday through received by the Hearing Clerk on or other tolerances and exemptions. Friday, excluding legal holidays. The before January 8, 2013. Addresses for Section 408(e) of FFDCA allows EPA to telephone number for the Public mail and hand delivery of objections establish a tolerance or an exemption Reading Room is (202) 566–1744, and and hearing requests are provided in 40 from the requirement of a tolerance on the telephone number for the OPP CFR 178.25(b). its own initiative, i.e., without having

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received any petition from an outside on this pesticide indicate that the EPA has evaluated the use of party. residues are not safe. dinotefuran on pome fruits and stone Section 18 of FIFRA authorizes EPA Because these time-limited tolerances fruits, as well as various other crops, to exempt any Federal or State agency are being approved under emergency and recently established tolerances for from any provision of FIFRA, if EPA conditions, EPA has not made any similar use patterns, in the Federal determines that ‘‘emergency conditions decisions about whether dinotefuran Register issue of September 12, 2012 (77 exist which require such exemption.’’ meets FIFRA’s registration requirements FR 56133) (FRL–9359–6) in association EPA has established regulations for use on pome fruits and stone fruits with requests for tolerances to support governing such emergency exemptions or whether permanent tolerances for registrations of dinotefuran under in 40 CFR part 166. this use would be appropriate. Under section 3 of FIFRA. these circumstances, EPA does not Consistent with FFDCA section III. Emergency Exemptions for believe that these time-limited tolerance 408(b)(2)(D), and the factors specified in Dinotefuran on Pome Fruits and Stone decisions serve as a basis for registration FFDCA section 408(b)(2)(D), EPA has Fruits and FFDCA Tolerances of dinotefuran by a State for special reviewed the available scientific data Several States requested emergency local needs under FIFRA section 24(c). and other relevant information in exemptions claiming that the abrupt Nor do these tolerances by themselves support of this action. EPA has increase and spread of damaging serve as the authority for persons in any sufficient data to assess the hazards of populations of the Brown Marmorated State other than Delaware, Maryland, and to make a determination on Stink Bug (BMSB) resulted in an urgent New Jersey, North Carolina, aggregate exposure for dinotefuran and non-routine pest control situation. Pennsylvania Virginia, and West including exposure resulting from the The available insecticides for BMSB Virginia to use this pesticide on the tolerances established by this action. In the September 12, 2012 Federal control are either ineffective, adversely applicable crops under FIFRA section Register issue, EPA published a final impact integrated pest management 18 absent the issuance of an emergency rule establishing tolerances for residues programs, and/or have use limitations exemption applicable within that State. of dinotefuran in 40 CFR 180.603(a) in that make them unsuitable for season- For additional information regarding the or on berry, low growing, except long control of BMSB. The States emergency exemptions for dinotefuran, strawberry, subgroup 13–07H; fruit, asserted that without the use of contact the Agency’s Registration small, vine climbing, except fuzzy dinotefuran as an additional pest Division at the address provided under kiwifruit, subgroup 13–07F; onion, bulb, management tool for pome and stone FOR FURTHER INFORMATION CONTACT. subgroup 3–07A; onion, green, subgroup fruit orchards, uncontrolled infestations IV. Aggregate Risk Assessment and 3–07B; peach; tea, dried; vegetable, of BMSB are likely to result in economic Determination of Safety tuberous and corm, subgroup 1C; and losses in excess of 20%. After having watercress. A summary of the reviewed the submissions, EPA Section 408(b)(2)(A)(i) of FFDCA toxicological endpoints for dinotefuran determined that an emergency condition allows EPA to establish a tolerance (the used for human risk assessment is exists for these States, and that the legal limit for a pesticide chemical discussed in Units III.A. and B. of the criteria for approval of the emergency residue in or on a food) only if EPA September 12, 2012 final rule. exemptions were met. EPA authorized determines that the tolerance is ‘‘safe.’’ The human health risk assessment specific exemptions under FIFRA Section 408(b)(2)(A)(ii) of FFDCA used to support the September 12, 2012 section 18 for the use of dinotefuran on defines ‘‘safe’’ to mean that ‘‘there is a final rule (‘‘Dinotefuran: Human Health pome fruits and stone fruits for control reasonable certainty that no harm will Risk Assessment for Proposed Section 3 of the BMSB in Delaware, Maryland, result from aggregate exposure to the Uses on Tuberous and Corm Vegetables New Jersey, North Carolina, pesticide chemical residue, including Subgroup 1C, Onion Subgroup 3–07A, Pennsylvania, Virginia, and West all anticipated dietary exposures and all Onion Subgroup 3–07B, Small Fruit Virginia. other exposures for which there is Subgroup 13–07F, Berry Subgroup 13– Consistent with the need to move reliable information.’’ This includes 07H, Peach, and Watercress, And a quickly on the emergency exemptions in exposure through drinking water and in Tolerance on Imported Tea’’), took into order to address an urgent non-routine residential settings, but does not include account the assumption that dinotefuran situation and to ensure that the resulting occupational exposure. Section would be used on pome fruits and stone food is safe and lawful, EPA is issuing 408(b)(2)(C) of FFDCA requires EPA to fruits pursuant to emergency these tolerances without notice and give special consideration to exposure exemptions. opportunity for public comment as of infants and children to the pesticide Therefore the aggregate risks for provided in FFDCA section 408(l)(6). chemical residue in establishing a dinotefuran for this action are not Although these time-limited tolerances tolerance and to ‘‘ensure that there is a changed from those discussed in the expire on December 31, 2015, under reasonable certainty that no harm will September 12, 2012 final rule. FFDCA section 408(l)(5), residues of the result to infants and children from In its aggregate assessment of pesticide not in excess of the amounts aggregate exposure to the pesticide exposures and risks associated with specified in the tolerances remaining in chemical residue * * *.’’ dinotefuran, EPA concluded the or on pome fruits and stone fruits after As part of its evaluation of the following: That the acute dietary that date will not be unlawful, provided emergency exemption applications, EPA exposure from food and water to the pesticide was applied in a manner assessed the potential risks presented by dinotefuran will occupy 5.8% of the that was lawful under FIFRA, and the residues of dinotefuran in or on pome acute population adjusted dose (aPAD) residues do not exceed a level that was fruits and stone fruits. In doing so, EPA for children 1–2 years old, the authorized by these time-limited considered the safety standard in population group receiving the greatest tolerances at the time of that FFDCA section 408(b)(2), and EPA exposure; that chronic exposure to application. EPA will take action to decided that the necessary tolerances dinotefuran from food and water will revoke these time-limited tolerances under FFDCA section 408(l)(6) would be utilize 2.6% of the chronic population earlier if any experience with, scientific consistent with the safety standard and adjusted dose (cPAD) for children 1–2 data on, or other relevant information with FIFRA section 18. years old, the population group

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receiving the greatest exposure; and that email address: residuemethods@epa. contain any information collections the combined short-term risk from food, gov. subject to OMB approval under the water, and residential exposures result Paperwork Reduction Act (PRA) (44 B. International Residue Limits in an aggregate margin of exposure U.S.C. 3501 et seq.), nor does it require (MOE) of 3,000 for children 1–2 years In making its tolerance decisions, EPA any special considerations under old from hand to mouth exposure from seeks to harmonize U.S. tolerances with Executive Order 12898, entitled treated turf, the scenario with the international standards whenever ‘‘Federal Actions to Address highest exposure. Because EPA’s level possible, consistent with U.S. food Environmental Justice in Minority of concern for dinotefuran is a MOE of safety standards and agricultural Populations and Low-Income 100 or below, the MOEs are not of practices. EPA considers the Populations’’ (59 FR 7629, February 16, concern. Based on the lack of evidence international maximum residue limits 1994). of carcinogenicity in two adequate (MRLs) established by the Codex Since tolerances and exemptions that rodent carcinogenicity studies, Alimentarius Commission (Codex), as are established in accordance with dinotefuran is not expected to pose a required by FFDCA section 408(b)(4). FFDCA sections 408(e) and 408(l)(6), cancer risk to humans. The Codex Alimentarius is a joint such as the tolerances in this final rule, Therefore, EPA concluded that there United Nations Food and Agriculture do not require the issuance of a is a reasonable certainty that no harm Organization/World Health proposed rule, the requirements of the will result to the general population and Organization food standards program, Regulatory Flexibility Act (RFA) (5 to infants and children from aggregate and it is recognized as an international U.S.C. 601 et seq.) do not apply. exposure to dinotefuran residues. Refer food safety standards-setting This final rule directly regulates to the September 12, 2012 final rule, organization in trade agreements to growers, food processors, food handlers, available at http://www.regulations.gov, which the United States is a party. EPA and food retailers, not States or tribes, for a summary of the aggregate risk may establish a tolerance that is nor does this action alter the assessments and determination of different from a Codex MRL; however, relationships or distribution of power safety. A more detailed discussion of the FFDCA section 408(b)(4) requires that and responsibilities established by aggregate risk assessments and EPA explain the reasons for departing Congress in the preemption provisions determination of safety may be found at from the Codex level. of FFDCA section 408(n)(4). As such, There are currently no Codex, http://www.regulations.gov in the the Agency has determined that this Canadian or Mexican MRLs established document titled ‘‘Revised: Dinotefuran: action will not have a substantial direct for dinotefuran. Human Health Risk Assessment for effect on States or tribal governments, Proposed Section 3 Uses on Tuberous VI. Conclusion on the relationship between the national and Corm Vegetables Subgroup 1C, Therefore, time-limited tolerances are government and the States or tribal Onion Subgroup 3–07A, Onion established for residues of dinotefuran, governments, or on the distribution of Subgroup 3–07B, Small Fruit Subgroup (RS)-1-methyl-2-nitro-3-((tetrahydro-3- power and responsibilities among the 13–07F, Berry Subgroup 13–07H, Peach, furanyl)methyl)guanidine, including its various levels of government or between and Watercress, And a Tolerance on metabolites and degradates, in or on the Federal Government and Indian Imported Tea’’ in docket ID number fruit, pome, group 11 and fruit, stone, tribes. Thus, the Agency has determined EPA–HQ–OPP–2011–0433. group 12 at 1.0 ppm. These tolerances that Executive Order 13132, entitled EPA relies upon those risk ‘‘Federalism’’ (64 FR 43255, August 10, assessments and the findings made in expire on December 31, 2015. EPA is also revising 40 CFR 1999) and Executive Order 13175, the Federal Register document in 180.603(b) to use the same systematic entitled ‘‘Consultation and Coordination support of this action. chemical name for dinotefuran as is with Indian Tribal Governments’’ (65 FR V. Other Considerations presently used in 40 CFR 180.603(a), for 67249, November 9, 2000) do not apply purposes of consistency within the to this final rule. In addition, this final A. Analytical Enforcement Methodology section and with EPA’s policy regarding rule does not impose any enforceable There are several analytical methods chemical nomenclature. duty or contain any unfunded mandate available for determination of residues as described under Title II of the of dinotefuran and its metabolites. For VII. Statutory and Executive Order Unfunded Mandates Reform Act of 1995 determination of dinotefuran and its Reviews (UMRA) (2 U.S.C. 1501 et seq.). metabolites, DN, 1-methyl-3-(tetrahydro- This final rule establishes tolerances This action does not involve any 3-furylmethyl)guanidine, and UF, 1- under FFDCA sections 408(e) and technical standards that would require methyl-3-(tetrahydro-3- 408(l)(6). The Office of Management and Agency consideration of voluntary furylmethyl)urea, a high performance Budget (OMB) has exempted these types consensus standards pursuant to section liquid chromatography/tandem mass of actions from review under Executive 12(d) of the National Technology spectrometry (HPLC/MS/MS) method is Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act of 1995 available. For the determination of Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note). residues of dinotefuran only, an HPLC/ October 4, 1993). Because this final rule VIII. Congressional Review Act ultraviolet (UV) detection method is has been exempted from review under available. For the determination of only Executive Order 12866, this final rule is Pursuant to the Congressional Review the metabolites (DN and UF), HPLC/MS not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will and HPLC/MS/MS methods are entitled ‘‘Actions Concerning submit a report containing this rule and available. These methods are adequate Regulations That Significantly Affect other required information to the U.S. to enforce the tolerance expression. Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of The methods may be requested from: FR 28355, May 22, 2001) or Executive Representatives, and the Comptroller Chief, Analytical Chemistry Branch, Order 13045, entitled ‘‘Protection of General of the United States prior to Environmental Science Center, 701 Children from Environmental Health publication of the rule in the Federal Mapes Rd., Ft. Meade, MD 20755–5350; Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major telephone number: (410) 305–2905; April 23, 1997). This final rule does not rule’’ as defined by 5 U.S.C. 804(2).

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List of Subjects in 40 CFR Part 180 PART 180—[AMENDED] metabolites and degradates, in or on the commodities in the following table, Environmental protection, ■ 1. The authority citation for part 180 resulting from use of the pesticide Administrative practice and procedure, continues to read as follows: pursuant to FIFRA section 18 Agricultural commodities, Pesticides Authority: 21 U.S.C. 321(q), 346a and 371. emergency exemptions. Compliance and pests, Reporting and recordkeeping with the tolerance levels specified in the requirements. ■ 2. In § 180.603, revise paragraph (b) to table is to be determined by measuring Dated: November 1, 2012. read as follows: only the sum of dinotefuran and its metabolites DN, 1-methyl-3-(tetrahydro- Lois Rossi, § 180.603 Dinotefuran; tolerances for 3-furylmethyl)guanidine, and UF, 1- Director, Registration Division, Office of residues. methyl-3-(tetrahydro-3- Pesticide Programs. * * * * * furylmethyl)urea, calculated as the Therefore, 40 CFR chapter I is (b) Section 18 emergency exemptions. stoichiometric equivalent of amended as follows: Time-limited tolerances are established dinotefuran, in or on the commodities for residues of dinotefuran, (RS)-1- listed in the table. The tolerances expire methyl-2-nitro-3-((tetrahydro-3- and are revoked on the dates specified furanyl)methyl)guanidine, including its in the table.

Parts per Expiration/rev- Commodity million ocation date

Fruit, pome, group 11 ...... 1.0 12/31/15 Fruit, stone, group 12 ...... 1.0 12/31/15 Rice, grain ...... 2.8 12/31/12

* * * * * procedures: it allows for the well as events that occur from various [FR Doc. 2012–27403 Filed 11–8–12; 8:45 am] reimbursement of the straight- or regular other causes, such as fires, floods, and BILLING CODE 6560–50–P time salaries and benefits of the explosions. When a locality is, or will employees of Public Assistance be, overwhelmed by the magnitude of applicants who perform disaster-related the damage from any such event, the DEPARTMENT OF HOMELAND debris and wreckage removal work for community turns to the State for help. SECURITY any major disaster or emergency If it is evident that the situation is or declared by the President on or after will be beyond the combined Federal Emergency Management October 27, 2012, in response to capabilities of local and State resources, Agency Hurricane Sandy. the Governor may request that the DATES: This interim final rule is President declare that an emergency or 44 CFR Part 206 effective November 9, 2012, and major disaster exists in the State, under [Docket ID FEMA–2012–0004] applicable October 27, 2012. Comments the authority of the Robert T. Stafford must be submitted by January 8, 2013. Disaster Relief and Emergency RIN 1660–AA75 Assistance Act (Stafford Act), 42 U.S.C. ADDRESSES: You may submit comments, 5121–5207. Debris Removal: Eligibility of Force identified by Docket ID FEMA–2012– If the President declares an emergency Account Labor Straight-Time Costs 0004, by one of the following methods: or major disaster and authorizes Public Federal eRulemaking Portal: http:// Under the Public Assistance Program Assistance, FEMA may award Public for Hurricane Sandy www.regulations.gov. Follow the Assistance grants to assist State and instructions for submitting comments. local governments (including Indian AGENCY: Federal Emergency Mail/Hand Delivery/Courier: Tribal governments) and certain private Management Agency, DHS. Regulatory Affairs Division, Office of ACTION: Interim final rule. nonprofit (PNP) organizations as Chief Counsel, Federal Emergency defined in subpart H of 44 CFR part 206 Management Agency, Room 835, 500 C SUMMARY: The Fiscal Year 2007 (collectively referred to as ‘‘applicants,’’ Department of Homeland Security Street, SW., Washington, DC 20472. ‘‘grantees,’’ or ‘‘subgrantees’’). Public Appropriations Act authorized a Public FOR FURTHER INFORMATION CONTACT: Assistance grants assist State, Tribal, Assistance Pilot Program intended to William Roche, Director, Public and local governments with the reduce the costs to the Federal Assistance Division, Federal Emergency response to and recovery from the government of providing assistance to Management Agency, 500 C Street SW., declared event. Specifically, the Public States and local governments; increase Washington, DC 20472–3100, (phone) Assistance program provides assistance flexibility in the administration of 202–212–2340; or (email) for debris removal, emergency assistance; and expedite the provision of [email protected]. protective measures, and permanent assistance under the Robert T. Stafford SUPPLEMENTARY INFORMATION: restoration of public infrastructure. Disaster Relief and Emergency FEMA refers to debris removal and Assistance Act. Due to the current I. Background emergency protective measures as pressing need for efficient and timely A. The Public Assistance Program ‘‘emergency work.’’ FEMA also recovery from a catastrophic disaster categorizes these types of work as event, Hurricane Sandy, which has cast 1. General Category A (debris removal) and widespread debris over a major portion Each year, the United States is struck Category B (emergency protective of the eastern seaboard of the United by natural disasters, which may include measures). Category B includes debris States, this rule implements one of the events such as storms, earthquakes, removal costs that are incurred as debris-related Public Assistance Pilot volcanic eruptions, and landslides, as emergency protective measures, such as

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clearing debris to establish immediate reduce the costs to the Federal contract for debris removal work, even emergency access. Permanent government of providing debris-related after relatively small events which restoration of infrastructure, which assistance to States and local could have been handled in part, or FEMA refers to as ‘‘permanent work,’’ governments, increase flexibility in the entirely, by an applicant’s employees. includes several categories, including administration of assistance, and For over a decade, State and local Roads and Bridges (Category C), Water expedite the provision of assistance applicants have requested Control Facilities (Category D), under sections 403(a)(3)(A), 502(a)(5), reimbursement for straight-time salaries Buildings and Equipment (Category E), and 407 of the Stafford Act. FEMA for their force account labor who are Utilities (Category F), and Parks, implemented four of the six Pilot pulled away from their normal day-to- Recreational Facilities, and Other Items procedures authorized by the day work to perform debris removal (Category G). This rulemaking applies to Appropriations Act for the operations. In response to these requests debris removal activities only administration of Public Assistance and under the Force Account Labor (Categories A and B). grants. The four initiatives that FEMA procedure of the Pilot Program, FEMA offered as part of the Pilot were: grants reimbursed the straight-time salaries 2. Debris Removal based on estimates (for Category A and and benefits of the applicant’s Sections 403(a)(3)(A), 407 and C–G large projects up to $500,000); an employees who performed disaster- 502(a)(5) of the Stafford Act authorize increased Federal cost share for debris related debris and wreckage removal FEMA to provide assistance to eligible removal projects for applicants with a work. FEMA’s objective in reimbursing applicants to remove debris from public FEMA-approved debris management force account labor was to provide and private property following a plan; reimbursement of straight-time applicants the opportunity and Presidential major disaster or emergency wages for applicant force account labor incentive to use their own employees declaration, when in the public interest. performing disaster related debris for debris removal activities in See 42 U.S.C. 5170b(a)(3)(A), 5173, and removal work; and a debris recycling situations where applicants determine 5192. Removal must be necessary to initiative. The Appropriations Act also that is the most appropriate method to eliminate immediate threats to lives, gave FEMA the authority to waive perform the work. In addition, FEMA public health and safety, eliminate regulations and policies to implement wanted to evaluate whether debris immediate threats of significant damage the Public Assistance Pilot Program. It removal operations and monitoring to improved public or private property, allowed State and local governments to performed by force account labor was or ensure the economic recovery of the participate in the Public Assistance less costly and more efficient than affected community-at-large. See 44 CFR Pilot Program on a voluntary basis. contractor operations. 206.224. The debris must be the direct Public Assistance applicants were not Feedback received on the Public result of the disaster and located in the required to use the Pilot procedures, but Assistance Pilot Program indicated that disaster area, and the applicant must could elect to use one or more of the the Force Account Labor procedure have the legal responsibility to remove Pilot procedures for one or more of its resulted in administrative benefits. the debris. To ensure these requirements projects. The Appropriations Act did States and FEMA Regional Offices are met, FEMA has issued extensive not authorize the participation of reported that grant applicants who guidance on oversight processes and private non-profit applicants in the Pilot utilized this procedure relied less on procedures to monitor debris removal Program. FEMA was prohibited from contractors, which resulted in fewer activities. approving any Pilot projects after complaints and negotiation over costs In the immediate aftermath of an December 31, 2008, and was required to and scopes of work and thus eliminated event, the removal of debris is a critical submit a report to Congress regarding delays in accomplishing the work. aspect of a community’s economic the effectiveness of the Pilot Program. FEMA also found that the Force recovery and return to normalcy. Debris On May 20, 2009, FEMA submitted the Account Labor procedure provided blocks roadways prohibiting the passage report, entitled ‘‘FEMA Public applicants an incentive to monitor of police, fire, and medical teams. Assistance Pilot Program Fiscal Year debris removal activities of contractors Debris slows repairs and reconstruction 2009 Report to Congress.’’ with its regular employees, rather than of essential buildings and homes. It also This rule implements one of the enter into contracts to perform the work. may cause health and safety problems if debris-related Pilot Program procedures, Indeed, ninety percent of all applicants left to fall on passersby, grow mold, or Force Account Labor, for disaster- participating in the Public Assistance foster insect infestation. related debris and wreckage removal Pilot Program requested reimbursement Between January 1, 1999, and work for any major disaster or for straight- or regular time salary and December 1, 2010, FEMA obligated an emergency declared by the President on benefits for their permanent employees annual average of 3,940 Project or after October 27, 2012, in response to who performed at least some of the Worksheets (PWs) and $675,534,796 for Hurricane Sandy. monitoring or debris removal activities. Category A, Debris Removal for major Under the current Public Assistance This large participation rate, coupled disasters and emergency declarations. program, FEMA only pays overtime for with reporting from the States and This figure does not include Category B an applicant’s own labor forces and FEMA Regions, shows that reimbursing debris removal work, including work to equipment, referred to as ‘‘force account straight-time for an applicant’s regular remove debris blocking emergency labor,’’ performing debris removal work. employees who performed debris response; therefore, the total amount of The regular time (also called ‘‘straight- removal work provided an incentive for debris removal funded during this time time’’) salaries and benefits of applicants to complete debris removal period is even higher. permanently employed personnel are work themselves rather than entering not eligible in calculating allowable into contracts to perform the work. B. The Public Assistance Pilot Program costs. See 44 CFR 206.228(a)(2). The Force Account Labor procedure The Fiscal Year (FY) 2007 Department However, FEMA reimburses reasonable of the Public Assistance Pilot Program of Homeland Security Appropriations costs associated with a debris contract, also resulted in cost and time savings. Act (Appropriations Act), Public Law including the cost of contract workers’ Funding straight- or regular time force 109–295, authorized FEMA to conduct a regular time as well as overtime. This account labor costs provided applicants Public Assistance Pilot Program to creates an incentive for applicants to an incentive to manage debris

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operations more effectively and declared by the President before October (a)(2) of section 206.228. The rule also decreased the number of contractors 27, 2012. Finally, reimbursement is establishes a cross reference to the required to both perform debris restricted to 30 consecutive calendar exception for host state evacuation and operations and monitor debris removal days. These provisions will provide an sheltering in 44 CFR 206.202. contractors. Not only did it reduce incentive to applicants to maximize the III. Administrative Procedure Act contractor costs, but it also allowed use of their force account labor, thus applicants to stop paying for contract lessening the need to secure and oversee FEMA has good cause to publish this equipment, and use their own contract labor, and encouraging them to interim final rule without notice and equipment for debris operations. allot 100 percent of the work time of comment under 5 U.S.C. 553(b)(3)(B), as Funding the straight-time of an their regular staff to Hurricane Sandy it would be impracticable, unnecessary applicant’s employees also provided debris removal, thereby contributing to and contrary to the public interest. The additional flexibility to local a quicker and more efficient recovery. impacts of Hurricane Sandy illustrate governments, allowing them to use a Eligible activities include disaster- the need for promulgating this rule as combination of contracting and force related debris and wreckage removal quickly as possible. Between October account labor for debris removal work. work for any major disaster or 28, 2012 and October 31, 2012, In addition, because applicants emergency declared by the President on Hurricane Sandy produced widespread started debris operations more or after October 27, 2012, in response to wind, storm surge, flood, and snow expeditiously, and reduced or Hurricane Sandy under Category A, damage to the Mid-Atlantic and eliminated delays related to procuring Debris Removal, and/or Category B, Northeast regions of the United States. and mobilizing contractors, the force Emergency Protective Measures. Before Hurricane Sandy had even made account provision of the Pilot Program Emergency work is that work which landfall the President issued emergency resulted in faster obligation of funding must be performed to reduce or declarations for nine States, authorizing from FEMA. FEMA obligated funds for eliminate an immediate threat to life, Federal resources to assist those States debris removal projects that used the protect public health and safety, and to with their preparations for the historic Force Account Labor procedure in 60 protect improved property that is storm. Hurricane force winds were percent less time than for those that threatened as a result of the disaster. See experienced along portions of the coasts used contractors for debris removal 44 CFR 206.225. Debris removal work, from Virginia to Massachusetts. On projects. whether labeled as Category A or October 29, 2012, Hurricane Sandy Category B, must be in the public made landfall as a post-tropical cyclone II. Discussion of the Rule interest. See 44 CFR 206.224. In with maximum sustained winds of 85 This rule implements the Force practice, FEMA treats debris removal miles per hour, which corresponds to a Account Labor procedure of the Public work the same whether it is under strong Category 1 hurricane on the Saffir Assistance Pilot Program for debris Category A or under Category B. Simpson Scale. Landfall occurred very removal work related to Hurricane Therefore, this rule makes straight-or close with high tide in many areas, Sandy, a catastrophic disaster event of regular-time salaries and benefits for an resulting in substantial storm surge unprecedented magnitude and severity. eligible applicant’s force account labor including almost 14 feet in New York The geographic depth of this storm is eligible in calculating the cost of eligible City, and the Holland and Brooklyn- exceptional, covering major portions of Category A and/or Category B debris Battery tunnels remain closed due to the Mid-Atlantic and Northeast, and removal work. This rule does not allow flooding as of October 30, 2012. Thus bringing devastation to much of the for the reimbursement of straight- or far, Sandy is responsible for 30 fatalities Eastern seaboard. In response to this regular time salaries and benefits of a in the United States, with search and event, FEMA is promulgating this rule grantee’s or subgrantee’s permanently rescue operations still ongoing. to accelerate the nation’s recovery by employed personnel for any other Efficient and effective debris maximizing the use of force account emergency protective measures under operations are arguably the single most labor. A 2011 Department of Homeland Category B. important step toward community Security Inspector General Report Non-Substantive Changes. recovery following a major disaster—the recommended that FEMA implement This rule adds a reference to ability of residents to return and live in the force account labor procedure in ‘‘grantee’’ in paragraph (a)(2) of section a safe and healthy environment depends some form, especially for an event of 206.228; it currently only refers to on the quality of the debris response. this magnitude, which would assist in ‘‘subgrantees.’’ The eligibility of force Since 2000, the Public Assistance reducing the occurrence of waste, fraud, account labor costs outlined in 44 CFR Program awarded over $8 billion in and abuse. 206.228(a)(2) applies to grantees as well grant funding—nearly 20 percent of all This rule revises 44 CFR 206.228(a)(2) as subgrantees. The State, in most cases, Public Assistance grants obligated to allow the reimbursement of straight- acts as the grantee for the Public during the period—to reimburse eligible or regular-time salaries and benefits of Assistance Program. Applicants who are applicants for debris removal. In a grantee’s or subgrantee’s permanently successful in obtaining Public addition, over $3 billion has been employed personnel for debris removal Assistance are identified as expended on Direct Federal Assistance work due to Hurricane Sandy performed ‘‘subgrantees.’’ Since State, Tribal, and related to debris removal. While the full under the Stafford Act’s Major Disaster local government agencies are eligible scope of the damage from Sandy has yet Assistance Programs (sections 403 and applicants for Public Assistance, States to be determined, United States Army 502) or Emergency Assistance Programs may act as the grantee, as well as the Corps of Engineering modeling (section 407). In order to receive subgrantee. While most work is estimates that a Category 1 hurricane reimbursement, force account labor performed by the subgrantees, it is making landfall in approximately the employees must work exclusively on possible that grantees could perform same area as Sandy could result in an Hurricane Sandy debris removal. They eligible debris removal and/or excess of 27.3 million cubic yards of cannot combine Hurricane Sandy debris permanent work, and therefore incur debris, spread across nine states and the removal with their normal work-related straight-time force account labor costs District of Columbia. tasks or any other tasks, including tasks for those activities. To be more accurate, Removing the current disincentive to related to emergencies or major disasters this rule adds ‘‘grantee’’ to paragraph applicants using their own employees

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for debris removal operations will not require an environmental quantifying both costs and benefits, of encourage applicants to use their own assessment or environmental impact reducing costs, of harmonizing rules, labor forces to perform debris work that statement. 40 CFR 1508.4. FEMA’s ‘‘List and of promoting flexibility. This rule may be done more quickly, more of exclusion categories’’ at 44 CFR has been designated a ‘‘significant efficiently, and at less cost than going 10.8(d)(2)(ii) categorically excludes the regulatory action’’ under section 3(f) of through a procurement process and preparation, revision, and adoption of Executive Order 12866. Accordingly, bringing in debris removal contractors. regulations related to actions that the rule has been reviewed by the Office This rule implements a procedure that qualify for categorical exclusions. of Management and Budget. has already been thoroughly tested Further, essential assistance under The rule provides (unquantified) through a Pilot Program in which any section 403 and debris removal under benefits that are vitally important to eligible State or local government was section 407 of the Stafford Act are further FEMA’s mission. This rule welcome to participate. Over 4,000 categorically excluded at 44 CFR increases efficiency, flexibility, and applicants chose to participate, and 10.8(d)(2)(xix)(B) and (C). These reduces the costs of performing debris FEMA’s analysis of the Pilot program categorical exclusions cover all debris removal work after Hurricane Sandy. indicated that it was very beneficial to removal actions under the Stafford Act. The rule affects States, Indian Tribal those applicants. State and local Finally, FEMA has evaluated the governments, local governments, as well governments that participated in the potential for extraordinary as certain private non-profit Pilot program were highly supportive of circumstances as required in 44 CFR organizations that have been affected by this procedure. In addition, the 10.8(d)(3) and determined that the Hurricane Sandy, by maximizing the Department of Homeland Security’s procedure authorized under this rule use of force account labor for debris Office of Inspector General has does not change its environmental removal, thus accelerating the recovery recommended that this procedure be effect. The straight-time force account process. implemented in some form. labor provision does not change the Review of FEMA’s existing debris Due to the widespread, significant nature or extent of debris removal regulations revealed that they could be impact of disasters like Hurricane activities reimbursed by FEMA. The expanded to provide for more efficient Sandy, and given that the procedure potential for reimbursement of straight- and timely debris removal after a implemented by this interim final rule time force account labor provides disaster. As discussed earlier in this was extensively tested during the Public applicants with more flexibility to preamble, the reimbursement of force Assistance Pilot Program, FEMA has perform debris removal work with their account labor for debris removal under determined that it would be own employees in addition to, or in the Pilot Program greatly improved impracticable, unnecessary, and place of, contractors, but does not affect efficient and timely debris removal. In contrary to the public interest to delay the eligibility of debris removal actions reimbursing force account labor, FEMA putting the provisions of this interim under this program. An environmental provided applicants with an incentive final rule in place until a public notice assessment was not prepared for this to perform the work in-house, as well as and comment process has been rulemaking action because a categorical improve oversight of debris removal completed. We find good cause to waive exclusion applies and no extraordinary operations. Therefore, FEMA is the notice of proposed rulemaking and circumstances exist. expanding the debris regulations to incorporate this procedural to issue this final rule on an interim B. Paperwork Reduction Act of 1995 basis. We will accept public comments improvement into the debris removal As required by the Paperwork on this interim final rule for 60 days. program in response to Hurricane Reduction Act of 1995 (PRA), as We are also dispensing with the Sandy. amended, 44 U.S.C. 3501 et seq., an Administrative Procedure Act agency may not conduct or sponsor, and D. Executive Order 13132, Federalism requirement that a new rule not take a person is not required to respond to, Executive Order 13132, ‘‘Federalism’’ effect until 30 days after it is issued. a collection of information unless the (64 FR 43255, Aug. 10, 1999), sets forth Instead, this rule is effective October 27, collection of information displays a principles and criteria that agencies 2012, to allow the maximum benefit for valid control number. The collection of must adhere to in formulating and Hurricane Sandy debris removal information associated with the Public implementing policies that have operations. Immediate effectiveness is Assistance program is approved under federalism implications, that is, authorized because this is a substantive OMB Control No. 1660–0017, which regulations that have ‘‘substantial direct rule granting an exception to the expires on April 30, 2013. This rule effects on the States, on the relationship prohibition on reimbursing Public does not contain any new collections of between the national government and Assistance applicants for their straight- information. the States, or on the distribution of time force account labor costs associated power and responsibilities among the with debris removal in response a major C. Executive Order 12866, Regulatory various levels of government.’’ Federal disaster or emergency. In addition, for Planning and Review & Executive Order agencies must closely examine the the reasons set forth above, there is good 13563, Improving Regulation and statutory authority supporting any cause to make the procedure Regulatory Review action that would limit the implemented by this rule effective Executive Orders 13563 and 12866 policymaking discretion of the States immediately. direct agencies to assess the costs and and, to the extent practicable, must IV. Regulatory Analysis benefits of available regulatory consult with State and local officials alternatives and, if regulation is before implementing any such action. A. National Environmental Policy Act necessary, to select regulatory FEMA has reviewed this rule under (NEPA) approaches that maximize net benefits Executive Order 13132 and has CEQ regulations provide for Federal (including potential economic, concluded that this rule does not have agencies to establish categories of environmental, public health and safety federalism implications as defined by actions that do not individually or effects, distributive impacts, and Executive Order 13132. FEMA has cumulatively have a significant impact equity). Executive Order 13563 determined that this rule does not on the human environment which do emphasizes the importance of significantly affect the rights, roles, and

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responsibilities of States, and involves F. Executive Order 13175, Consultation one year. UMRA exempts from its no preemption of State law nor does it and Coordination with Indian Tribal definition of ‘‘Federal limit State policymaking discretion. Governments intergovernmental mandate’’ regulations This rulemaking amends a voluntary FEMA has reviewed this rule under that establish conditions of Federal grant program that may be used by Executive Order 13175 ‘‘Consultation assistance or provide for emergency assistance or relief at the request of any State, local and Tribal governments and and Coordination with Indian Tribal eligible private nonprofit organizations State, local, or Tribal government. Governments’’ (65 FR 67249, Nov. 9, to receive Federal grants to assist in the Therefore, this rule is not an unfunded 2000). Under Executive Order 13175, recovery from disasters. States are not Federal mandate under that Act. FEMA may not issue a regulation that required to seek grant funding, and this has Tribal implications, that imposes I. Executive Order 12988, Civil Justice rulemaking does not limit their substantial direct compliance costs on Reform policymaking discretion. Indian Tribal governments, and that is This rule meets applicable standards E. Executive Order 12898, not required by statute. In reviewing in sections 3(a) and 3(b)(2) of Executive Environmental Justice this rule, FEMA finds that because Order 12988, ‘‘Civil Justice Reform’’ (61 Under Executive Order 12898, as Indian Tribal governments are FR 4729, Feb. 7, 1996), to minimize amended ‘‘Federal Actions to Address potentially eligible applicants under the litigation, eliminate ambiguity, and Environmental Justice in Minority Public Assistance Program, this rule reduce burden. Populations and Low-Income does have ‘‘tribal implications’’ as J. Executive Order 12630, Governmental Populations’’ (59 FR 7629, Feb. 16, defined in the Executive Order. Actions and Interference With 1994), FEMA has undertaken to However, eligibility to receive Constitutionally Protected Property incorporate environmental justice into reimbursement for force account labor Rights its policies and programs. Executive for debris removal operations will not Order 12898 requires each Federal have a substantial direct effect on one or FEMA has reviewed this rule under agency to conduct its programs, more Indian Tribes, on the relationship Executive Order 12630, ‘‘Governmental policies, and activities that substantially between the Federal Government and Actions and Interference with affect human health or the environment, Indian Tribes, or on the distribution of Constitutionally Protected Property in a manner that ensures that those power and responsibilities between the Rights’’ (53 FR 8859, Mar. 18, 1988) as programs, policies, and activities do not Federal Government and Indian Tribes. supplemented by Executive Order have the effect of excluding persons This rule does not impose substantial 13406, ‘‘Protecting the Property Rights from participation in, denying persons direct compliance costs on Indian Tribal of the American People’’ (71 FR 36973, the benefit of, or subjecting persons to governments nor does it preempt tribal June 28, 2006). Sections 403(a)(3)(A) discrimination because of their race, law, impair treaty rights nor limit the and 407 of the Stafford Act, 42 U.S.C. color, or national origin or income level. self-governing powers of Indian Tribal 5170b and 5173, respectively, provide The purpose of this rule is to governments. FEMA authority to fund debris removal implement a debris-related Public from private property provided that the G. Regulatory Flexibility Act Statement Assistance Pilot Program procedure. State or local government arranges an This rule reimburses straight- or regular Under the Regulatory Flexibility Act unconditional authorization for removal time wages for the permanent (RFA), 5 U.S.C. 601–612, and section of the debris, and agrees to indemnify employees of Public Assistance 213(a) of the Small Business Regulatory the Federal government against any applicants while they perform disaster- Enforcement Fairness Act of 1996, 5 claim arising from the removal. The related debris and wreckage removal U.S.C. 601 note, agencies must consider regulations implementing Sections 403 activities related to Hurricane Sandy for the impact of their rulemakings on and 407 of the Stafford Act at 44 CFR a period of 30 consecutive calendar ‘‘small entities’’ (small businesses, small 206.224 establish the requirement that days. Reimbursing straight- or regular organizations and local governments). debris removal be in the ‘‘public time for an applicant’s permanent The term ‘‘small entities’’ comprises interest’’ in order to be eligible for employees who perform debris removal small businesses, not-for-profit reimbursement. Generally, debris work will provide an incentive for organizations that are independently removal from private property following applicants to complete debris removal owned and operated and are not a disaster is the responsibility of the work themselves rather than entering dominant in their fields, and property owner. However, large-scale into contracts to perform the work. governmental jurisdictions with disasters may deposit enormous Removing debris expeditiously provides populations of less than 50,000. This quantities of debris on private property value to the American people by rule does not require a notice of over a large area resulting in widespread creating safer communities and proposed rulemaking and therefore is immediate threats to the public-at-large. reducing loss of life and property, exempt from the requirements of the In these cases, the State or local enables communities to recover more RFA. government may need to enter private rapidly from disasters, and lessens the property to remove debris to: Eliminate H. Unfunded Mandates Reform Act financial impact of disasters on immediate threats to life, public health, individuals, the United States The Unfunded Mandates Reform Act and safety; eliminate immediate threats Department of the Treasury, State, local of 1995 (UMRA), 2 U.S.C. 1501 et seq., of significant damage to improved and Tribal communities. requires each Federal agency, to the property; or ensure economic recovery No action that FEMA can anticipate extent permitted by law, to prepare a of the affected community to the benefit under this rule will have a written assessment of the effects of any of the community-at-large. In these disproportionately high and adverse Federal mandate in a proposed or final situations, debris removal from private human health or environmental effect agency rule that may result in the property may be considered to be in the on any segment of the population. expenditure by State, local, and Tribal public interest and thus may be eligible Accordingly, the requirements of governments, in the aggregate, or by the for reimbursement under the Public Executive Order 12898 do not apply to private sector, of $100 million or more Assistance Program. See 44 CFR this rule. (adjusted annually for inflation) in any 206.224. FEMA will work with States

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affected by a disaster to designate those benefits of a grantee’s or subgrantee’s October 10, 2012 and released on areas where the debris is so widespread permanently employed personnel are: October 12, 2012. The full text of this that removal of the debris from private (i) Eligible in calculating the cost of document is available for public property is in the ‘‘public interest’’ eligible permanent repair, restoration, inspection and copying during regular pursuant to 44 CFR 206.224, and thus is and replacement of facilities under business hours in the FCC Reference eligible for FEMA Public Assistance section 406 of the Stafford Act; Center, Federal Communications reimbursement on a case-by-case basis. (ii) Eligible, at the Administrator’s Commission, 445 12th Street SW., CY– This rule will not affect a taking of discretion, in calculating the cost of A257, Washington, DC 20554. This private property or otherwise have eligible debris removal work under document will also be available via taking implications under Executive sections 403(a)(3)(A), 502(a)(5), and 407 ECFS (http://www.fcc.gov/cgb/ecfs/). Order 12630. of the Stafford Act for a period not to (Documents will be available exceed 30 consecutive calendar days, electronically in ASCII, Word 97, and/ K. Congressional Review of Agency provided the grantee’s or subgrantee’s or Adobe Acrobat.) The complete text Rulemaking permanently employed personnel are may be purchased from the FEMA is sending the rule to Congress dedicated solely to eligible debris Commission’s copy contractor, 445 12th and to the Government Accountability removal work for any major disaster or Street SW., Room CY–B402, Office pursuant to the Congressional emergency declared by the President on Washington, DC 20554. To request these Review of Agency Rulemaking Act or after October 27, 2012, in response to documents in accessible formats (Congressional Review Act)(CRA), Hurricane Sandy; and (computer diskettes, large print, audio Public Law 104–121, 110 Stat. 873 (iii) Not eligible in calculating the cost recording, and Braille), send an email to (March 29, 1996) (5 U.S.C. 801 et seq). of other eligible emergency protective [email protected] or call the Commission’s This rule is not a ‘‘major rule’’ within measures under sections 403 and 502 of Consumer and Governmental Affairs the meaning of the CRA. Furthermore, the Stafford Act, except for those costs Bureau at (202) 418–0530 (voice), (202) Section 808 of the CRA allows the associated with host state evacuation 418–0432 (TTY). issuing agency to make a rule effective and sheltering, as established in Summary of the Report and Order sooner than otherwise provided by the § 206.202. 1. With this Report and Order (Order), CRA if the agency makes a good cause * * * * * finding that notice and public procedure we amend our rules to allow cable is impracticable, unnecessary or Janet Napolitano, operators to encrypt the basic service contrary to the public interest. As stated Secretary. tier in all-digital cable systems if they previously, FEMA has made such a [FR Doc. 2012–27382 Filed 11–8–12; 8:45 am] comply with certain consumer- protection measures. As discussed good cause finding, including the BILLING CODE 9111–23–P reasons therefore. below, this rule change will benefit consumers who can have their cable List of Subjects in 44 CFR Part 206 service activated and deactivated from a FEDERAL COMMUNICATIONS remote location. By allowing remote Administrative practice and COMMISSION procedure, Coastal zone, Community activation and deactivation, we expect facilities, Disaster assistance, Fire 47 CFR Part 76 our amended rules will result in prevention, Grant programs-housing and benefits to both cable operators and community development, Housing, [MB Docket No. 11–69; PP Docket No. 00– consumers by significantly reducing the 67; FCC 12–126] Insurance, Intergovernmental relations, number of truck rolls associated with provisioning service and significantly Loan programs-housing and community Basic Service Tier Encryption reducing the need for subscribers to development, Natural resources, Compatibility Between Cable Systems wait for service calls to activate or Penalties, Reporting and recordkeeping and Consumer Electronics Equipment requirements. deactivate cable service. At the same For the reasons discussed in the AGENCY: Federal Communications time, we recognize that this rule change preamble, the Federal Emergency Commission. will adversely affect a small number of Management Agency amends 44 CFR ACTION: Final rule. cable subscribers who currently view part 206 as follows: the digital basic service tier without SUMMARY: In this document, the using a set-top box or other equipment. PART 206—FEDERAL DISASTER Commission adopts new rules to allow If a cable operator decides to encrypt the ASSISTANCE cable operators to encrypt the basic digital basic tier, then these subscribers service tier in all-digital systems, will need equipment to continue ■ 1. The authority citation for part 206 provided that those cable operators viewing the channels on this tier. To is revised to read as follows: undertake certain consumer protection give those consumers time to resolve the Authority: Robert T. Stafford Disaster measures for a limited period of time in incompatibility between consumer Relief and Emergency Assistance Act, 42 order to minimize any potential electronics equipment (such as digital U.S.C. 5121 through 5207; Homeland subscriber disruption. television sets) and newly encrypted Security Act of 2002, 6 U.S.C. 101 et seq.; DATES: Effective December 10, 2012. cable service, we require operators of Department of Homeland Security Delegation cable systems that choose to encrypt the FOR FURTHER INFORMATION CONTACT: 9001.1. For basic service tier to comply with certain additional information on this consumer protection measures for a ■ 2. Revise § 206.228, paragraph (a)(2) to proceeding, contact Brendan Murray, read as follows: period of time. In addition, we note that [email protected], of the Media this rule change may impact the ability § 206.228 Allowable costs. Bureau, Policy Division, (202) 418– of a small number of subscribers that 2120. * * * * * use certain third-party equipment that is (a) * * * SUPPLEMENTARY INFORMATION: This is a not CableCARD compatible to access (2) Force Account Labor Costs. The summary of the Commission’s Report channels on the basic service tier. To straight- or regular-time salaries and and Order, FCC 12–126, adopted on address this issue, we require the six

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largest incumbent cable operators to scramble most of their signals. As cable such systems because they already have comply with additional requirements operators began to transition a set-top box or CableCARD-equipped that are intended to ensure programming on their cable retail device. Furthermore, they compatibility with certain third-party- programming service tier (‘‘CPST’’) to contend, encrypting the basic service provided equipment used to access the digital, many program carriage tier in an all-digital system would basic tier. agreements required cable operators to eliminate the need for many service 2. Background. In the Cable encrypt that programming as a calls because it would allow cable Television Consumer Protection and condition of carriage. In addition, cable operators to enable and disable cable Competition Act of 1992 (‘‘1992 Cable operators use encryption as part of their service remotely, activating and Act’’), Congress sought to make sure that conditional access system to ensure that deactivating the encryption capability of consumer electronics equipment could cable service is available only to those set-top boxes and CableCARDs from the receive cable programming and that who have paid for it. Particular methods headend rather than visiting compatibility issues did not limit the of encryption, however, vary across subscribers’ homes. Today, cable premium features of that equipment. cable systems, which could lead to operators typically must manually Section 17 of that law added section incompatibility between consumer connect and disconnect the cable that 624A to the Communications Act of devices and cable service. In 2003, the runs to a home to activate or deactivate 1934, as amended. Section 624A Commission adopted the CableCARD service and use traps to block access to requires the Commission to issue standard to address this incompatibility particular channels. If the cable operator regulations to assure compatibility problem. The CableCARD, which were allowed to encrypt every signal, between consumer electronics subscribers must lease from their cable the operator could keep every home equipment and cable systems. In 1994, provider either as a part of a leased set- connected to the cable plant regardless the Commission implemented the top box or separately for use in a of whether the home subscribes to cable requirements of section 624A in part by compatible retail television or set-top service. In addition, the operator could adding § 76.630(a) to its rules. Section box, decrypts the cable services. At ensure that only paid subscribers are 76.630(a) prohibits cable operators from present, over 78 percent of all cable able to access the service by authorizing scrambling or encrypting signals carried subscribers have at least one leased set- and deauthorizing CableCARDs, or other on the basic tier of service. Encryption top box or retail CableCARD device in legitimate devices, as people subscribe is an essential component of a their home. Cable operators who offer to or cancel cable service. conditional access system, which cable only digital service indicate that all of 6. In January 2010, the Media Bureau operators use to ensure that subscribers their subscribers have at least one leased granted a conditional waiver of the rule receive only the services that they are set-top box or retail CableCARD device. authorized to receive. Nevertheless, the that prohibits encryption of the basic Some cable subscribers rely on QAM service tier to Cablevision with respect Commission determined that this rule tuners in television sets and consumer would significantly advance to Cablevision’s New York City systems, electronics devices that allow access to which are all-digital. The Bureau based compatibility by ensuring that all unencrypted digital cable service subscribers would be able to receive its decision on the fact that encryption without additional equipment, but, of the basic service tier on Cablevision’s basic tier signals ‘‘in the clear’’ and that based on the record before us, we basic-only subscribers with cable-ready all-digital systems would allow believe that few consumers rely on them Cablevision to enable and disable cable televisions would not need set-top for primary access to cable service. The boxes. The Commission concluded that service remotely. The Bureau also found fact that most cable subscribers already ‘‘[t]his rule also will have minimal that remote activation and deactivation have a cable set-top box or retail impact on the cable industry in view of of cable service would ‘‘reduce[ ] costs CableCARD device significantly reduces the fact that most cable systems now for Cablevision, improve[ ] customer the number of subscribers who benefit generally do not scramble basic tier service, and reduce[ ] fuel consumption from the prohibition on encryption of signals.’’ and CO2 emissions.’’ Remote activation 3. In the mid-1990’s, cable operators the basic service tier in all-digital and deactivation, the Bureau concluded, began to upgrade their systems to offer systems in contrast to systems that carry would reduce installation costs for digital cable service in addition to analog service. Cablevision’s subscribers and also analog cable service (hybrid service). 5. Our rules state that requests for benefit these subscribers by reducing More recently, many cable operators waiver of the encryption prohibition the number of occasions when they have transitioned to more efficient all- ‘‘must demonstrate either a substantial must wait at home for a service call, as digital service, freeing up spectrum to problem with theft of basic tier service compared to unencrypted cable systems. offer new or improved products and or a strong need to scramble basic The Bureau reasoned that Cablevision services like higher-speed Internet signals for other reasons.’’ Prior to 2010, would sufficiently address the problem access and high definition the Commission had waived the rule of incompatibility with consumer programming. After a cable operator based only on theft of service. Recently, electronics ‘‘by providing basic-only transitions to an all-digital system, most the Commission has received several subscribers with set-top boxes or of its subscribers have at least one cable requests for waiver of the rule CableCARDs without charge for set-top box or retail CableCARD device prohibiting encryption of the basic significant periods of time.’’ Finally, the in their homes. We expect that the service tier based on the argument that Bureau also concluded that the waiver percentage of homes with set-top boxes the rule imposes more burdens than would ‘‘provide an experimental benefit or retail CableCARD devices will benefits as cable operators transition to that could be valuable in the continue to increase as more cable all-digital systems. The petitioners argue Commission’s further assessment of the operators eliminate analog service from that there are very few people who utility of the encryption rule,’’ and their systems in favor of more efficient subscribe only to the basic service tier therefore required Cablevision to file digital service. in all-digital systems, and that access to three reports detailing the effect of 4. The percentage of homes with set- the basic tier would therefore be encryption on subscribers. Four cable top boxes or CableCARD devices is high unaffected by encryption for the operators have filed similar petitions for because most cable systems now overwhelming majority of subscribers to waiver with the Commission’s Media

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Bureau since the release of the burdens. Finally, we discuss the legal encryption disparity on a consumer-by- Cablevision Waiver. basis for the rule changes. consumer basis could lead to consumer 7. In the wake of these petitions as 9. Systems Eligible to Encrypt. In the confusion: Under this proposal, one well as requests from Public Knowledge Encryption NPRM, the Commission subscriber could be subject to and Media Access Project for the proposed to allow encryption of the encryption (and the commensurate Commission to deal with the basic basic service tier only with respect to consumer-protection measures service tier encryption issue by all-digital systems ‘‘because remote described below), while his neighbor launching a rulemaking proceeding, the activation and deactivation of cable could face no encryption and be able to Commission issued a Notice of service, and its attendant benefits, are access channels on the basic service tier. Proposed Rulemaking in October 2011. only feasible in all-digital systems.’’ For The administrative burdens of The Commission proposed to allow this reason, we limit encryption determining the applicability of the rule cable operators to encrypt the basic eligibility of the basic tier to all-digital would also make such a proposal service tier in all-digital systems, subject systems. The Commission proposed to unreasonable. Therefore, we believe that to conditions that would minimize define an ‘‘all-digital’’ system as one in our rule, which determines eligibility disruption for affected subscribers by which ‘‘no television signals are for encryption on a system-wide basis, providing a transition period in which provided using the NTSC system.’’ As is more reasonable and will better serve to make informed choices about explained below, we adopt our the public interest. purchasing or leasing new equipment to proposed definition, finding that it will 12. Benefits of Permitting Basic continue accessing service. Based on the best achieve our goal of facilitating Service Tier Encryption. Remote reports that Cablevision submitted as a remote activation and deactivation of Activation and Deactivation. Based on condition of its waiver, the Commission cable service ‘‘while minimizing examination of the record, we are in the Encryption NPRM predicted that interference with the special functions persuaded that allowing encryption of the rule change would reduce truck rolls of subscribers’ television sets.’’ the basic service tier on all-digital 10. Commenters suggested several and service calls with modest adverse systems will reduce the need for many substantive changes to our proposed effects on few subscribers. We received consumers to schedule a service call rule. Several commenters suggested that comments or reply comments on the and wait for the cable technician to we extend encryption eligibility to cable Encryption NPRM from 34 parties, and arrive before initiating or terminating operators that offer unencrypted analog a number of subsequent ex parte filings. their cable service. ACA states in its ‘‘barker channels.’’ Mikrotec and Inter comments that physical connection and The parties’ positions are described in Mountain Cable suggested that operators disconnection of cable service in all- the ensuing Discussion. should be allowed to encrypt the basic digital systems is ‘‘unnecessary but for 8. Discussion. Because of the public service tier as long as all the existence of the basic service tier benefits associated with allowing all- ‘‘programming’’ on the basic tier is encryption prohibition.’’ Comcast digital cable operators to encrypt the transmitted digitally and ‘‘if that predicts that encrypting the basic basic service tier, we amend our rule to condition is met, then there should be service tier will allow the company to permit this practice as long as the cable no concern that the system otherwise perform nearly half of its activations operator complies with certain uses analog modulation.’’ They also and 90 percent of its deactivations consumer protection measures. suggest that eligibility to encrypt should remotely. Cablevision reports that, since Encryption of all-digital cable service be determined subscriber-by-subscriber, it received waiver of the encryption will allow cable operators to activate not on a system-by-system basis, prohibition, 99.5 percent of its and deactivate cable service remotely, because cable operators may elect to deactivations were performed remotely thus relieving many consumers of the transition portions of systems to all- and a growing number of its new need to schedule appointments when digital piecemeal, and the rule should customers are eligible for remote they sign up for or cancel cable service. not discourage that practice. activation. The result for consumers is In addition, encryption will reduce the 11. We believe the best criterion for that in many cases they will no longer number of truck rolls necessary for eligibility to encrypt the basic service need to rearrange their schedules to wait manual installations and tier is that the system carries only for cable technicians to arrive at their disconnections, reduce service theft, digital signals aside from unencrypted homes in order to activate and and establish regulatory parity between analog barker channels. Encryption on deactivate their cable service, making cable operators and their satellite hybrid systems (that is, systems that activation and deactivation of service competitors, who are not subject to the transmit signals in analog and digital) much more convenient. encryption rule. We find these benefits would not generate the benefits 13. In addition to the projected time offset the increased burdens that may associated with encryption on all-digital savings for subscribers because of result from encryption of the basic systems because the analog portion of remote activation and deactivation, the service tier. Recognizing, as noted the system will still require truck rolls record is replete with secondary benefits above, that some consumers rely on to activate and deactivate service and that cable operators and their customers unencrypted basic tier service, we adopt the Commission does not have a will realize as a result of remote service narrowly tailored consumer protection separated security solution like change. These include savings for cable measures to help ease the transition to CableCARD to ensure that retail devices operators because of a reduction in the encrypted service for those consumers. can access scrambled analog cable need to dispatch service technicians to In the sections below, we first discuss programming. Therefore, permitting customers’ homes. For example, which systems will be allowed to hybrid systems to encrypt would not commenters assert that reduced costs encrypt the basic service tier. Then we result in the type of benefits that justify due to truck rolls and system discuss the benefits associated with easing the encryption requirement for maintenance will save cable operators permitting all-digital cable operators to all-digital systems. We do not believe money that they can use to ‘‘invest in encrypt the basic service tier, as well as that it is practical to adopt Mikrotec and innovative new products that customers the burdens associated with our rule Inter Mountain Cable’s proposal to demand and highly value.’’ In addition, change and consumer protection determine eligibility for encryption on a Comcast states that, with remote measures we adopt to mitigate those consumer-by-consumer basis, because activation and deactivation,

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‘‘technicians would need to access drop instances, a CableCARD. As a result, access the basic tier without an lines less frequently, thereby reducing almost all digital subscribers already use additional equipment charge while they ‘wear-and-tear’ on the lines and the set-top boxes or CableCARDs to access consider their options for device need for maintenance.’’ Many cable service. Second, since the 1992 compatibility. In this section, we commenters also highlight the benefits Cable Act, satellite television operators identify the small class of subscribers remote activation and deactivation will have begun to offer video programming that encryption may affect and adopt have on vehicle traffic and the services to tens of millions of two categories of measures to protect environment. Microtek and Inter subscribers, who access these services those subscribers: Transitional Mountain Cable even suggest that these through the use of one or more equipment requirements and notice increased efficiencies could lead to converter boxes. Our rules do not requirements. lower rates for subscribers. prohibit satellite operators from 17. Subscribers That May Be Affected 14. Reduction of Theft and Piracy. encrypting their services, and therefore by Encryption of the BST. The Another benefit of basic tier encryption they are able to make service changes Commission concluded in 1994 that is the likely reduction in theft of cable remotely and in real time. Cable service. In 2004, NCTA estimated that operators argue that this puts them at a adopting the basic service tier five percent of homes passed receive regulatory disadvantage vis-a`-vis their encryption prohibition ‘‘will have unauthorized cable service, which competitors that are not constrained by minimal impact on the cable industry in equates to five billion dollars in the requirements of § 76.630(a). We view of the fact that most cable systems unrealized revenue that cable operators believe that by amending our encryption now generally do not scramble basic tier could dedicate to offering improved rule we will reduce this regulatory signals.’’ Today our examination of the services. The resulting reduction in disparity and enable all-digital cable record reflects that relaxing the cable operator revenues may increase operators to provide a similar level of encryption prohibition for all-digital the rates operators charge their customer service as their MVPD systems will have minimal impact on subscribers. In addition, Comcast competitors. consumers because most subscribers do explains that theft of service reduces the not rely on the clear-QAM tuners in 16. Consumer Protection Measures to quality of cable service because thieves Reduce Burdens on Subscribers. their devices to access basic tier signals. sometimes access the cable system by Although we expect our rule change Nevertheless, we recognize that lifting splitting cables and adding will affect relatively few subscribers, we the encryption prohibition may impact unauthorized taps, which degrade nonetheless adopt consumer protection some cable subscribers who use clear- connections and can lead to signal QAM devices to access the basic tier, leakage and lower broadband speeds. measures to mitigate any resulting harm to subscribers who are impacted by such as subscribers who use second or This unauthorized splicing also can add third television sets to access to wear-and-tear on the cable system encryption of the digital basic tier. This rule change will impact the few digital unencrypted digital basic service tier and increase the need for maintenance. service without set-top boxes or Encryption of the basic service tier will cable subscribers who access the basic service tier without a set-top box or CableCARDs and subscribers that use discourage thieves from splicing cable third-party provided IP-enabled devices lines as it will not enable viewing of the CableCARD: They will need to obtain a set-top box or CableCARD from their that have clear-QAM tuners. Several signals without leasing an authorized cable subscribers and equipment set-top box or CableCARD from the cable operator once the operator encrypts the basic service tier. To give manufacturers filed comments claiming operator. Encryption of the basic service that our rule change would have a tier could also benefit channels that are these consumers time to assess their options to access encrypted cable negative impact on them. These carried on the basic service tier, as subscribers explain that they rely on developers of high-value content may be service, we will require cable operators that choose to encrypt to offer affected clear-QAM tuners in their electronic more willing to make the content devices (such as computers and available to basic service tier channels subscribers equipment necessary to television sets) to access basic tier if they are encrypted and less receive the encrypted programming programming, and that because they susceptible to piracy. without charge for a limited time, and 15. Regulatory Parity. Several to notify their subscribers about have more than two devices on which commenters emphasized that the encryption and the equipment offers. In to view BST programming (e.g., they proposed rule change will increase addition, we require the six largest have multiple televisions in their regulatory parity between cable incumbent cable operators to offer home), their monthly bills will increase operators and satellite providers, which equipment that is compatible with IP- because they will need a greater number are not subject to the encryption rule. enabled clear-QAM devices provided by of converter boxes than afforded under Commenters explain that the technology third parties. We intend that this the free box conditions that the and market landscapes were quite requirement will provide an Commission proposed in the Encryption different when the rule was adopted, opportunity for affected consumers to NPRM. We are concerned about the when consumers had a reasonable make informed choices about whether effect of this rule change on the small expectation that they would be able to to purchase a CableCARD-compatible group of subscribers who access connect their televisions directly to a device, lease a set-top box from their unencrypted basic service tier coaxial cable without the need for a set- cable operator, or use another method to programming through clear-QAM top box. In the years since enactment of access the broadcast and other channels receivers, but, at the same time, the 1992 Cable Act, consumer carried on the basic service tier (for recognize that no consumer protection expectations have changed example, by accessing the signals over- measure could fully satisfy every substantially. First, cable operators have the-air or via another MVPD). As we affected subscriber. Nonetheless, we introduced new and innovative services, explained in the Encryption NPRM, believe that the consumer-protection such as video on demand and pay-per- such an opportunity will minimize the measures outlined below are view services, that cannot be accessed impact of encryption on clear-QAM appropriate and necessary to minimize by digital subscribers without an users by offering a transition period disruption to affected subscribers by authorized set-top box or, in some during which they can continue to providing a reasonable transition period

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to make informed choices about the because some consumers may own (ii) enable IP-enabled clear QAM options available to access the basic tier. third-party provided IP-enabled devices devices to access basic service tier 18. Transitional Equipment that do not have the ability to decrypt channels without any additional Requirements Applicable to All Cable cable signals. Therefore, these hardware through the use of Operators. To limit the costs that commenters call for the Commission to commercially available software affected consumers may face due to reject the proposed rule, or adopt upgrades (‘‘Option 2’’). NCTA proposed encryption, we adopt our proposed special measures to mitigate disruption to sunset these commitments three years consumer-protection measures that to consumers that use those third-party after we adopt this Order unless the require a cable operator that chooses to devices. Specifically, these parties Commission extends them. Boxee and encrypt the basic service tier to: (i) Offer complain that existing cable set-top CEA argue that these commitments do to existing subscribers who subscribe boxes and DTAs are not compatible not sufficiently support the operation of only to the basic service tier and do not with IP-enabled devices because they do IP-enabled clear QAM devices. Instead, use a set-top box or CableCARD, the not output signals in a manner that they advocate that all cable operators subscriber’s choice of a set-top box or third-party-provided IP-enabled devices should be required to make the basic CableCARD on up to two television sets can access. Accordingly, such devices service tier available to IP-enabled without charge for two years from the would not be compatible with the devices without additional hardware. date of encryption; (ii) offer existing operator’s free equipment offering—i.e., CEA further encourages the Commission subscribers who subscribe to a level of there would be no connection by which not to sunset the commitments after service above ‘‘basic only’’ but use an such devices could access the basic tier three years. The AllVid Alliance additional television set to access only channels—thus rendering such devices suggests that the Commission initiate a the basic service tier without the use of useless if a cable operator chooses to Notice of Proposed Rulemaking seeking a set-top box or CableCARD at the time encrypt the basic tier. Commenters comment on ‘‘a nationally-portable of encryption, the subscriber’s choice of assert that such devices were purchased common IP-based interface from MVPD a set-top box or CableCARD on one or manufactured on the expectation that services to consumer devices.’’ television set without charge for one unencrypted basic service tier QAM 21. We believe that the commitments year from the date of encryption; and signals would continue to be available from the six largest incumbent cable (iii) offer existing subscribers who from cable operators. The record operators will be sufficient to address receive Medicaid, subscribe only to the indicates that at least four companies the compatibility issue concerning IP- basic service tier, and do not use a set- have developed products that rely on enabled devices and achieve the top box or CableCARD, the subscriber’s customers’ ability to access clear-QAM objectives of section 624A of the Act— choice of a set-top box or CableCARD on signals, and that a relatively small i.e., to ensure compatibility between up to two television sets without charge number of consumers have purchased cable service and consumer electronics for five years from the date of these devices for this capability. As equipment. We do not extend the encryption. These consumer protections explained above, however, we additional equipment requirement to apply to televisions and devices anticipate the impact of encryption of smaller cable operators because we do connected to the cable system at the the basic tier on the public at large will not believe it is necessary at this time. time of encryption. To ensure that any be minimal because the record indicates As noted above, based on the current subscriber likely to be affected by that only a small number of consumers record, only a small number of consumers rely on IP-enabled devices to encryption has adequate time to rely on clear-QAM devices to access the consider these offers, we will require access the basic tier and thus we expect basic tier. And the record further cable operators to keep the offer open to this particular compatibility problem to indicates that subscribers who use IP- subscribers for at least 30 days before be extremely limited in scope. Because enabled clear-QAM devices that would the date the operator begins encrypting the six largest incumbent cable be incompatible with the free the first basic tier channel on the operators subject to the rule serve 86 equipment offerings by cable operators channel lineup and for at least 120 days percent of all cable subscribers represent an even smaller subset of after that date. NCTA suggested that the nationwide, we expect most consumers clear-QAM users. offer extend for only 30 days after the that use such devices will have ready date that encryption begins. We believe 20. To mitigate any harm to the small access to the necessary equipment. that 30 days after the date of encryption group of consumers that may use such Moreover, large cable operators would not afford affected consumers devices, NCTA’s six largest incumbent generally dictate equipment features to sufficient time to learn about the effect cable members—serving 86 percent of manufacturers and commonly get of encryption and the consumer- all cable subscribers—have committed priority in delivery of that equipment. protection measures available to them to adopt, prior to encrypting, a solution We anticipate that the large operators’ and act on the information. that would provide basic service tier demand for this equipment eventually Furthermore, because encryption will access to third-party provided IP- will lead all equipment to include this affect only a very small number of enabled clear QAM devices. Pursuant to functionality in the marketplace, and subscribers, the consumer protection this commitment, these six cable thus the equipment small cable measures we adopt will not be unduly operators will make basic service tier operators provide will eventually onerous on cable operators. We expect channels available either via connection include the IP functionality as well, these transitional protections will from operator-supplied equipment or by regardless whether they specify this substantially mitigate the costs to providing access to the operator’s particular feature. Nonetheless, we may affected subscribers while they consider security technology. Specifically, these revisit this issue if the equipment alternative means for accessing the basic cable operators have proposed to either market does not develop as expected or service tier. (i) provide a converter box with if we find that small cable operators do 19. Equipment Requirements ‘‘standard home networking capability’’ not make their service compatible with Applicable to Top Six Incumbent Cable that can provide IP-enabled clear QAM these consumer devices. Operators. A few commenters assert that devices access to basic service tier 22. Contrary to Boxee’s argument, the free equipment conditions described channels on the same terms proposed in nothing in section 624A requires that above do not mitigate any disruption the Encryption NPRM (‘‘Option 1’’), or consumer equipment compatibility be

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achieved by means of a hardware-free devices. Any license terms that cable 26. Public Knowledge and Media solution. Under the equipment measure operators require for the ‘‘standard Access Project also suggest that we tie we adopt today, the vast majority of home networking capability’’ used to the low-income condition to Lifeline/ consumers will be able to access service offer access to the basic service tier in Linkup eligibility because Medicaid that is encrypted using a commercially Option 1 and the ‘‘requirements eligibility can vary from state to state. available security technology or via necessary (including any authentication We reject that suggestion as equipment with standard home- processes)’’ in Option 2 must be made unnecessary. As several commenters networking capability in much the same available on a good faith basis. In point out, Medicaid eligibility presents way they do today. In fact, if this adopting this ‘‘good faith’’ licensing an easily verifiable, bright-line test, and standard home-networking capability is requirement, we intentionally do not is less likely to cause confusion among connected to a wireless home network, specify any particular technology or subscribers and cable customer service the consumer experience could improve technology licensing model (e.g., we do representatives. because consumers will be able to not require or specify ‘‘fair, reasonable, 27. We also reject calls from some access basic service tier channels and non-discriminatory’’ licensing, as commenters to require free equipment without physically connecting a device that term has been interpreted in other in perpetuity for existing subscribers, to a coaxial plug from the wall. Thus, contexts, as urged by Boxee and CEA). and not to limit free boxes to existing mandating a hardware-free solution is Third, we require the operators that subscribers. The consumer protection not necessary to protect consumers in choose to offer access to the basic measures we adopt are intended to the context of the instant proceeding. service tier using Option 1 to ‘‘publicly mitigate the disruption that may be 23. We adopt these commitments as disclose the DLNA profile or other experienced by current cable required preconditions to encrypting by protocol that is being used for the home- subscribers. We do not agree that free the top six incumbent cable operators networking capability on such operator- equipment is necessary for new with slight modifications and supplied equipment.’’ Such a subscribers: Given the movement to clarifications. These conditions will requirement is necessary to ensure that digital services, many subscribers have automatically sunset three years from third-party manufacturers have the become accustomed to leasing set-top the release date of this Order unless the information necessary to build a device devices, and that trend seems likely to Media Bureau (‘‘Bureau’’) determines that works with cable-provided continue. Furthermore, we agree with prior to this date that the IP-enabled equipment. We also remind cable NCTA that unnecessarily burdensome device protections remain necessary to operators that § 76.640(b)(4)(iii) of our conditions such as free devices for all protect consumers. We believe that a rules, which goes into effect in new subscribers could discourage cable future review of these rules is warranted December of this year, requires all high operators from encrypting and prevent because the market for these IP-based definition set-top boxes (except for one- the public from realizing the benefits devices is nascent and it is unclear way, non-recording set-top boxes) to that stem from cable operators’ ability to whether consumer demand for this include an IP-compatible output based remotely activate and deactivate service equipment will flourish. Accordingly, on an open industry standard that which benefits most subscribers. we delegate authority to the Bureau to provides for audiovisual Accordingly, we do not condition this initiate a review two years after the communications including service rule change on cable operators’ release of this Order to decide whether discovery, video transport, and remote supplying free devices in perpetuity to existing subscribers or to new these IP-enabled device protections control command pass-through remain necessary to protect consumers subscribers. standards for home networking. We or whether it is appropriate to sunset 28. Certain commenters express believe that these additional consumer the IP-enabled device protections. If the concern about the impact that basic protection measures will ease the Bureau does not release an order service tier encryption could have on transition to encrypted service for the extending these protections within three institutional subscribers and schools in vast majority of the small subset of years from the release date of this Order, particular. They suggest that the customers that rely on third-party then the consumer protection measures Commission extend the free-device provided IP-enabled devices to access concerning IP-enabled devices detailed consumer protections to institutional the basic service tier. above will no longer apply to the top- subscribers to prevent the rule change six cable operators for purposes of 25. Other Issues. Public Knowledge from placing a financial burden on encryption of the basic service tier. In and Media Access Project state in their them. Cable operators, however, suggest deciding whether the sunset is comments that there have been no that these commenters conflate appropriate, the Bureau shall consider complaints from customers in encryption with digitization, and we the costs to cable operators and the Cablevision’s encrypted systems about agree. As cable operators transition to benefits to consumers, whether ‘‘hidden fees’’ related to the free device all-digital service, these institutional competitive services are available, offers, and they anticipate that cable subscribers will need devices to convert regulatory parity between cable and operators ‘‘intend to act in good faith.’’ digital signals to analog regardless of other MVPDs, the state of technology Out of an abundance of caution, whether the service is encrypted unless and the marketplace, and cable however, they suggest we affirmatively the institutional subscribers use operators’ efforts to meet these state that cable operators may not television sets with clear-QAM tuners commitments and ensure compatibility. impose service fees (such as ‘‘digital and only use those televisions to access The Bureau shall also consider whether access fees’’ or ‘‘outlet fees’’) in lieu of the basic service tier. Furthermore, the IP-enabled device protections rental fees for the free devices. Comcast argues that cable operators should be extended to small cable Consistent with Public Knowledge and establish agreements with local operators. Media Access Project’s suggestion, we institutions on a case-by-case basis, and 24. Second, we add some clarifying clarify that boxes provided by cable that each franchising authority language to address Boxee and CEA’s operators that choose to encrypt the negotiates consumer protection concerns that cable operators could use basic service tier must be provided measures to meet its needs. We are licenses to limit retail device without any additional service charges persuaded that it is unnecessary to manufacturers from building compatible related to the equipment. adopt consumer-protection measures

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with respect to institutional subscribers, when cable operators must notify their end of the free device transitional because we expect that cable operators subscribers about encryption. Therefore, period, a cable operator that encrypts will continue to work with local we will require cable operators to notify must notify subscribers that have taken institutions—and may be required to do their subscribers that they will encrypt advantage of the transitional period that so by franchising authorities—to ensure at least 30 days before the date the period is ending as follows: that the institutions’ needs will be met. encryption of the basic service tier You currently receive equipment We emphasize that our rules are not commences, at which time they must necessary to descramble or decrypt the intended to limit or preempt existing, also include information about the basic service tier signals (either a set-top renegotiated, or future franchise transitional device requirements set box or CableCARD) free of charge. agreements that provide institutional forth in Section 76.630. The notice must Effective with the (MONTH/YEAR) subscribers more equipment on different state: billing cycle, (NAME OF CABLE terms than our rules require for On (DATE), (NAME OF CABLE OPERATOR) will begin charging you for residential subscribers. We expect that OPERATOR) will start encrypting the equipment you received to access cable operators will work closely with (INSERT NAME OF CABLE BASIC (INSERT NAME OF CABLE BASIC local franchising authorities and SERVICE TIER OFFERING) on your SERVICE TIER OFFERING) when institutions to ensure that any cable system. If you have a set-top box, (NAME OF CABLE OPERATOR) started disruption institutional subscribers digital transport adapter (DTA), or a encrypting those channels on your cable experience as a result of encryption will retail CableCARD device connected to system. The monthly charge for the be minimized. each of your TVs, you will be unaffected (TYPE OF DEVICE) will be (AMOUNT 29. ACA and BendBroadband express by this change. However, if you are OF CHARGE). concern about the effect that the currently receiving (INSERT NAME OF 33. While our rule prescribes the conditions will have on small cable CABLE BASIC SERVICE TIER language that cable operators must use operators. We agree with ACA and OFFERING) on any TV without to notify their subscribers about BendBroadband that in some instances equipment supplied by (NAME OF encryption and the device-based the benefits of encryption may be CABLE OPERATOR), you will lose the protection measures, we leave open the outweighed by the burdens of ability to view any channels on that TV. option for cable operators to supplement administrative upgrades to account for If you are affected, you should contact this notice as they see fit. We will not the new billing procedures needed to (NAME OF CABLE OPERATOR) to require the six largest incumbent cable offer free devices for a limited period of arrange for the equipment you need to operators to provide special notice to time. We note, however, that the continue receiving your services. In their subscribers about the availability decision to encrypt the basic service tier such case, you are entitled to receive of IP-enabled device compatibility, will be a voluntary decision made at the equipment at no additional charge or though they must comply with existing sole discretion of the cable operator service fee for a limited period of time. notice requirements. Third-party IP- under the rules we adopt here. Thus, The number and type of devices you are enabled device manufacturers have an each cable operator may use its business entitled to receive and for how long will economic incentive to ensure their judgment to decide whether, and when, vary depending on your situation. If you customers are aware of the functions the benefits of encryption outweigh the are a (INSERT NAME OF CABLE BASIC and features of their devices, e.g., costs of upgrading billing software and SERVICE TIER OFFERING) customer provide notice to their customers in providing equipment to its subscribers and receive the service on your TV marketing materials about the need to to ease the transition to encrypted without (NAME OF CABLE obtain IP-enabled equipment from their service. OPERATOR)-supplied equipment, you cable operator and the special 30. Notification Requirements. Based are entitled to up to two devices for two equipment the six largest incumbent on the record, we believe that years (five years if you also receive cable operators are required to offer notification requirements are also Medicaid). If you subscribe to a higher their subscribers under Commission necessary to protect consumers. level of service and receive (INSERT rules. Therefore, we will require cable NAME OF CABLE BASIC SERVICE 34. Public Knowledge and Media operators to notify their subscribers TIER OFFERING) on a secondary TV Access Project proposed that we require about the planned encryption and the without (NAME OF CABLE operators to notify subscribers when device offers at least 30 days before the OPERATOR)-supplied equipment, you their free device period is ending on date encryption of the basic tier are entitled to one device for one year. each monthly bill for the three months commences. We will also require cable You can learn more about this preceding the end of the transition operators to notify their subscribers at equipment offer and eligibility at period. We agree that preventing ‘‘bill least 30 days, but no more than 60 days, (WEBPAGE ADDRESS) or by calling shock’’ is important, and § 76.1603(d) of before the end of the free device (PHONE NUMBER). To qualify for any our rules requires cable operators to transitional period. These notifications equipment at no additional charge or provide written notice of any increase in are necessary to make the device-based service fee, you must request the price to be charged for equipment consumer protection measures equipment between (DATE THAT IS 30 necessary to access the basic service tier meaningful to consumers; the measures DAYS BEFORE ENCRYPTION) and at least 30 days before the increase is would be meaningless if affected (DATE THAT IS 120 DAYS AFTER effective. We do not believe that the consumers were not made aware of the ENCRYPTION) and satisfy all other three notices that Public Knowledge and offers. eligibility requirements. Media Access Project propose are 31. NCTA proposed that our rules 32. We believe that 30 days’ notice necessary. But we are concerned that require cable operators to notify their will provide a reasonable opportunity cable operators could notify their subscribers about encryption and free for affected consumers to avail subscribers too early in the transition device offers at least 30 days prior to the themselves of free device offers in period to render notification essentially date encryption of the basic service tier advance of basic service tier encryption meaningless. Therefore, we believe it is commences. Several commenters without unduly burdening cable important to define the window for supported NCTA’s proposal, and we operators. In addition, at least 30 days, notices more precisely so that affected agree that it is important to identify but no more than 60 days, before the subscribers are notified no more than 60

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days before the end of the transitional changes in cable systems, television existing rules, manufacturers should not free-device period. At that time, affected receivers, video cassette recorders and have indicated to consumers that subscribers can determine the course similar technology.’’ The record devices could receive digital cable that best suits their circumstances. suggests that to achieve the statutory service unless those devices were, in Some subscribers may opt to continue goals of section 624A a blanket ban on fact, CableCARD-compatible. Therefore, their current level of service and pay for encryption is no longer necessary, and we disagree with Montgomery County’s the additional equipment charges. Other that changes in cable technology justify characterization that encryption will subscribers may choose to reduce their relaxing the rule for all-digital cable lead to an abundance of compatibility level of service or terminate their systems, provided consumer protection problems due to the rule changes existing cable service and pursue a measures are addressed. As explained adopted herein. Section 624A(c)(1)(B) competitive alternative that better meets above, cable technology is markedly expressly directs the Commission to their service needs and budgets. different than it was when the consider ‘‘the costs and benefits to 35. The New York City Department of Commission first adopted the consumers of imposing compatibility Information Technology and encryption prohibition set forth in requirements on cable operators.’’ As Telecommunications (NYC DoITT) § 76.630. For example, the transition to discussed above, the costs associated argues that, because Cablevision’s all-digital systems means that with a blanket encryption prohibition in encryption of its New York City systems encryption of the basic service tier will all-digital systems greatly outweigh the is nascent, the Commission cannot be permit remote activation and anticipated benefits to consumers, sure of the long-term effects that basic deactivation of cable service resulting in particularly in light of the consumer service tier encryption may have. significant savings of time and resources protection measures we are also Therefore, NYC DoITT encourages the for both cable operators and the vast adopting. Furthermore, in 2010, the Commission to make this rule change majority of cable customers. Commission adopted changes to the temporary. We agree that we cannot Furthermore, as discussed below, the CableCARD rules, including streamlined predict how our rule change will affect CableCARD standard provides an device approval procedures, a self- the cable industry and subscribers with avenue for consumers to purchase installation option, and a prohibition on absolute certainty. The information consumer electronics devices that are price discrimination against CableCARD before us indicates, however, that this compatible with digital cable service, devices, that should increase the retail rule change will result in the substantial which achieves Congress’ stated goal in availability and the quality of public interest benefits discussed above section 624A. experience for CableCARD devices and and that any additional burdens further increase compatibility between imposed on a limited number of 37. Relaxing the encryption rule in this manner will not impede section consumer electronics and cable service subscribers will be tempered by the by ensuring that retail devices can consumer protection measures adopted 624A’s goal of compatibility between consumer electronics equipment and access all linear digital cable services. herein. The Commission will keep Given these technological and rule apprised of the consequences of the rule cable systems. The Commission has adopted a standard that allows for ‘‘plug changes, we conclude that a complete change and, if the situation develops prohibition on basic service tier differently than predicted, we can and play’’ compatibility between consumer electronics devices and cable encryption in all-digital systems is no revisit the issue on our own initiative or longer necessary to ensure compatibility in response to a petition for rulemaking. systems. This standard provides a clear path for device manufacturers to follow between consumer electronics devices In the future, we may seek information and cable service, provided certain from the operators that have chosen to if they wish to build devices that are consumer protection measures are encrypt to ensure that the expected compatible with digital cable systems satisfied. benefits are being achieved and any and can access all linear digital cable burdens to consumers are being services. Montgomery County, Maryland 38. We also conclude that the minimized. However, nothing in the argues that the CableCARD standard is requirement in section 623(b)(3)(A) of record persuades us that it is necessary not successful, and that the Commission the Act to base any price or rate to build a sunset into the rule. should endeavor to relieve compatibility standards for equipment installation 36. Legal Basis. Section 624A of the problems, rather than compound them. and leasing on actual cost does not bar Communications Act provides the According to Montgomery County, the Commission from imposing the Commission broad authority to make relaxing the encryption rule will lead to consumer protection measures set forth changes to our encryption rule and to compatibility problems because in § 76.630(a)(1)(ii)–(vi) of our new impose the consumer-protection consumers will no longer be able to use rules. The commenters who addressed measures we adopt today. Congress’s clear-QAM tuners on non-primary our legal authority agree that the objective in enacting section 624A was television sets. However, the consumer protection measures—which to ensure compatibility between cable Commission has already adopted a are adopted as a transitional measure systems and consumer TV (receiving solution for compatibility between and implicate a limited number of and recording) equipment, consistent consumer electronics equipment and affected customers—do not run afoul of with the need to prevent theft of cable digital cable: The CableCARD standard section 623 of the Communications Act, service. Section 624A(b)(2) directs the is intended to allow consumers to buy and we did not receive any comments Commission to ‘‘determine whether compatible retail devices to access all claiming that the consumer protection and, if so, under what circumstances to linear digital cable services as opposed measures, as structured, would violate permit cable systems to scramble or to the basic-only service that clear-QAM section 623. These measures are not encrypt signals or to restrict cable tuners can access without additional being imposed as a regulation of systems in the manner in which they equipment. Indeed, the Commission’s equipment rates under section 623. encrypt or scramble signals.’’ Section cable-ready labeling rules prohibit Rather, the consumer protection 624A(d) directs the Commission to device manufacturers from labeling measures are being adopted pursuant to periodically review and modify their devices as ‘‘digital cable ready’’ section 624A(b)(2)’s broad grant of regulations adopted pursuant to section unless they comply with the authority to the Commission to 624A ‘‘to reflect improvements and CableCARD standards. Thus, under our determine ‘‘under what circumstances

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to permit cable systems to scramble or prepared a Final Regulatory Flexibility This present Final Regulatory Flexibility encrypt signals or to restrict cable Analysis (‘‘FRFA’’) relating to this Analysis (FRFA) conforms to the RFA. systems in the manner in which they Report and Order. The FRFA is set forth The Commission will send a copy of the encrypt or scramble signals.’’ We have below. R&O, including this FRFA, to the Chief determined that relaxing the encryption 43. Congressional Review Act. The Counsel for Advocacy of the Small prohibition should be permitted for all- Commission will send a copy of this Business Administration. In addition, digital systems, provided the potential Third Report and Order in a report to be the R&O and FRFA (or summaries harm to affected consumers is send to Congress and the Government thereof) will be published in the Federal minimized. Our new rule permits a Accountability Office pursuant to the Register. cable operator to elect to abide by the Congressional Review Act, see 5 U.S.C. 50. Need for, and Objectives of the encryption prohibition without having 801(a)(1)(A). Proposed Rules. With this Report and any obligation to offer subscribers 44. Ordering Clauses. Accordingly, it Order, the Commission amends its rules is ordered that, pursuant to the authority equipment for a transitional period. It is to allow cable operators to encrypt the contained in sections 1, 4(i), 4(j), 303(r), only when a cable operator chooses to basic service tier in all-digital cable 601, and 624A of the Communications encrypt the basic service tier that it is systems if they comply with certain Act of 1934, as amended, 47 U.S.C. 151, required to comply with the requisite consumer-protection measures. This 154(i), 154(j), 303(r), 521, and 544a, this regulatory conditions (by providing set- rule change will benefit consumers who top boxes at no cost to affected Report and Order is adopted. 45. It is further ordered that, pursuant can have their cable service activated subscribers for a limited transitional and deactivated from a remote location. period). Thus, this requirement is to the authority contained in sections 1, 4(i), 4(j), 303(r), 601, and 624A of the By allowing remote activation and imposed as a condition of a cable deactivation, we expect our amended operator’s voluntary election to encrypt Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), rules will result in benefits to both cable the basic service tier, and not as a rate operators and consumers by regulation imposed under section 303(r), 521, and 544a, Part 76 of the Commission’s rules is amended as set significantly reducing the number of 623(b)(3)(A). service calls associated with 39. Waiver Requests. As mentioned forth in the rules and is effective provisioning service and significantly above, the Commission has pending December 10, 2012. It is our intention reducing the need for subscribers to before it four petitions for waiver of the that all of the rule changes adopted in wait for service calls to activate or encryption ban. These petitions have this order are interdependent and deactivate cable service. At the same been pending for more than a year. inseparable and that if any provision of Petitioners seek immediate relief, the rules, or the application thereof to time, we recognize that this rule change claiming that they face extraordinary any person or circumstance, are held to will adversely affect a small number of theft of service. We find good cause to be unlawful or invalid, the remaining cable subscribers who currently view grant these waiver requests effective rule changes adopted herein shall not be the digital basic service tier without upon release of this Order to prevent effective. using a set-top box or other equipment. further delay. For the reasons set forth 46. It is further ordered that, pursuant If a cable operator decides to encrypt the above, these waivers are conditioned to § 1.3 of the Commission’s rules, 47 digital basic tier, then these subscribers upon the petitioners’ complying with CFR 1.3, the requests for waiver of will need equipment to continue the consumer protection requirements § 76.630(a) of the Commission’s rules, viewing the channels on this tier. To discussed in this Order. 47 CFR 76.630(a), filed by RCN give those consumers time to resolve the 40. Conclusion. We conclude that Corporation, Mikrotec CATV, LLC, Inter incompatibility between consumer allowing cable operators to encrypt the Mountain Cable, Inc., and Coaxial Cable electronics equipment (such as digital basic service tier in all-digital systems TV are granted, to the extent described television sets) and newly encrypted will result in substantial, tangible herein and conditioned as set forth cable service, we require operators of benefits to both consumers and cable above. cable systems that choose to encrypt the operators with minimal countervailing 47. It is further ordered that the basic service tier to comply with certain burdens on affected subscribers. We Commission’s Consumer and consumer protection measures for a believe that the consumer-protection Governmental Affairs Bureau, Reference period of time. The Commission measures that we adopt will mitigate Information Center, shall send a copy of concludes that allowing cable operators any burdens that encryption will have this Report and Order, including the to encrypt the basic service tier in all- on the limited number of consumers Final Regulatory Flexibility Analysis, to digital systems will lead to benefits like that may be affected by the instant rule the Chief Counsel for Advocacy of the decreased service calls and theft of change. Small Business Administration. service, with few associated burdens on 41. Paperwork Reduction Act 48. It is further ordered that the consumers. Therefore the Commission Analysis. The Report and Order in this Commission shall send a copy of this believes that this rule change will document does not contain proposed Report and Order in a report to be sent reduce burdens on small entities. The information collection(s) subject to the to Congress and the General Accounting Commission predicts that encryption of Paperwork Reduction Act of 1995 Office pursuant to the Congressional the basic service tier will not (PRA), Public Law 104–13. In addition, Review Act, see 5 U.S.C. 801(a)(1)(A). substantially affect compatibility therefore, it does not contain any new 49. As required by the Regulatory between cable service and consumer or modified information collection Flexibility Act of 1980, as amended electronics equipment for most burden for small business concerns with (RFA), an Initial Regulatory Flexibility subscribers because over 75 percent of fewer than 25 employees, pursuant to Analysis (IRFA) was incorporated in the subscribers already have set-top boxes the Small Business Paperwork Relief Notice of Proposed Rule Making to decrypt the signals. Because the rule Act of 2002, Public Law 107–198, see 44 (NPRM). The Commission sought is voluntary—a cable operator with an U.S.C. 3506(c)(4). written public comment on the all-digital system may choose whether 42. Final Regulatory Flexibility proposals in the NPRM, including to encrypt that system—each cable Analysis. As required by the Regulatory comment on the IRFA. No commenting operator may decide whether the Flexibility Act, the Commission has parties specifically addressed the IRFA. benefits of encryption (which include

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reduced service calls and reduced theft) amended, 47 U.S.C. 151, 154(i) and (j), Current Commission records show 6,000 outweigh the cost of providing its 303(r), 521, and 544a. cable systems. Of these, 726 have 20,000 subscribers with the equipment they 55. Description and Estimate of the subscribers or more, based on the same will need to continue viewing the Number of Small Entities to Which the records. We estimate that there are 5,000 channels on the basic service tier. Proposed Rules Will Apply. The RFA small systems based upon this standard. 51. The need for FCC regulation in directs the Commission to provide a 58. Cable System Operators (Telecom this area derives from changing description of and, where feasible, an Act Standard). The Communications technology in the cable services market. estimate of the number of small entities Act of 1934, as amended, also contains When the Commission adopted that will be affected by the proposed a size standard for small cable system technical rules in the 1990s, digital rules. The RFA generally defines the operators, which is ‘‘a cable operator cable service was in its infancy, and term ‘‘small entity’’ as having the same that, directly or through an affiliate, therefore the rules were adopted with meaning as the terms ‘‘small business,’’ serves in the aggregate fewer than 1 analog cable service in mind. Today, ‘‘small organization,’’ and ‘‘small percent of all subscribers in the United digital cable service is common, and the governmental entity’’ under Section 3 of States and is not affiliated with any encryption rule does not translate well the Small Business Act. In addition, the entity or entities whose gross annual in systems that offer all-digital service. term ‘‘small business’’ has the same revenues in the aggregate exceed Therefore, the Commission will allow meaning as the term ‘‘small business $250,000,000.’’ There are approximately all-digital cable operators to encrypt the concern’’ under the Small Business Act. 63.7 million cable subscribers in the basic service tier. A small business concern is one which: United States today. Accordingly, an 52. We recognize that some (1) Is independently owned and operator serving fewer than 637,000 consumers subscribe only to a cable operated; (2) is not dominant in its field subscribers shall be deemed a small operator’s digital basic service tier and of operation; and (3) satisfies any operator, if its annual revenues, when currently are able to do so without using additional criteria established by the combined with the total annual a set-top box or other equipment. Small Business Administration revenues of all its affiliates, do not Similarly, there are consumers that may (‘‘SBA’’). exceed $250 million in the aggregate. 56. Cable and Other Program have a set-top box on a primary Based on available data, we find that the Distribution. Since 2007, these services television but access the unencrypted number of cable operators serving have been defined within the broad digital basic service tier on second or 637,000 subscribers or less is also 804. economic census category of Wired We note that the Commission neither third televisions in their home without Telecommunications Carriers; that requests nor collects information on using a set-top box or other equipment. category is defined as follows: ‘‘This whether cable system operators are Although we expect the number of industry comprises establishments affiliated with entities whose gross subscribers in these situations to be primarily engaged in operating and/or annual revenues exceed $250 million. extremely small, these consumers may providing access to transmission Although it seems certain that some of be affected by lifting the encryption facilities and infrastructure that they these cable system operators are prohibition for all-digital cable systems. own and/or lease for the transmission of affiliated with entities whose gross To address this problem, we conclude voice, data, text, sound, and video using annual revenues exceed $250,000,000, that operators of all-digital cable wired telecommunications networks. we are unable at this time to estimate systems that choose to encrypt the basic Transmission facilities may be based on with greater precision the number of service tier must comply with certain a single technology or a combination of cable system operators that would consumer protection measures for a technologies.’’ The SBA has developed qualify as small cable operators under limited period of time in order to a small business size standard for this the definition in the Communications minimize any potential subscriber category, which is: All such firms Act. disruption, including a requirement that having 1,500 or fewer employees. 59. Direct Broadcast Satellite (‘‘DBS’’) the six largest cable operators offer IP- According to Census Bureau data for Service. DBS service is a nationally enabled set-top boxes to subscribers as 2007, there were a total of 955 firms in distributed subscription service that part of these protections. this previous category that operated for delivers video and audio programming 53. The Commission believes that the the entire year. Of this total, 939 firms via satellite to a small parabolic ‘‘dish’’ rule will save small entities money. The had employment of 999 or fewer antenna at the subscriber’s location. consumer protection element of the employees, and 16 firms had DBS, by exception, is now included in rule—the requirement that cable employment of 1000 employees or the SBA’s broad economic census operators offer existing basic tier more. Thus, under this size standard, category, ‘‘Wired Telecommunications customers set-top boxes without charge the majority of firms can be considered Carriers,’’ which was developed for for certain lengths of time—does small and may be affected by rules small wireline firms. Under this associate a cost with the rule. But the adopted pursuant to the NPRM. category, the SBA deems a wireline Commission believes that the financial 57. Cable Companies and Systems business to be small if it has 1,500 or benefit to small cable operators in (Rate Regulation Standard). The fewer employees. However, the data we reduced truck rolls and theft of services Commission has also developed its own have available as a basis for estimating will far outweigh that cost. Furthermore, small business size standards for the the number of such small entities were because the decision of whether to purpose of cable rate regulation. Under gathered under a superseded SBA small encrypt the basic tier is voluntary, small the Commission’s rules, a ‘‘small cable business size standard formerly titled businesses will be able to make a company’’ is one serving 400,000 or ‘‘Cable and Other Program business decision about whether to fewer subscribers nationwide. As of Distribution.’’ The definition of Cable encrypt. 2008, out of 814 cable operators, all but and Other Program Distribution 54. Legal Basis. The authority for the 10 (that is, 804) qualify as small cable provided that a small entity is one with action proposed in this rulemaking is companies under this standard. In $12.5 million or less in annual receipts. contained in sections 1, 4(i) and (j), addition, under the Commission’s rules, Currently, only two entities provide 303(r), 601, and 624A of the a ‘‘small system’’ is a cable system DBS service, which requires a great Communications Act of 1934, as serving 15,000 or fewer subscribers. investment of capital for operation:

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DIRECTV and EchoStar number of units served by the largest 10 manufacturing; that size standard is Communications Corporation PCOs, we believe that a substantial 1,000 or fewer employees. According to (‘‘EchoStar’’) (marketed as the DISH number of PCOs may have been 2007 Census Bureau data, there were Network). Each currently offer categorized as small entities under the 647 establishments in this category that subscription services. DIRECTV and now superseded SBA small business operated in 2007. Of these, only 62 had EchoStar each report annual revenues size standard for Cable and Other more than 100 employees. that are in excess of the threshold for a Program Distribution. Consequently, we estimate that the small business. Because DBS service 61. Open Video Services. The open majority of these establishments are requires significant capital, we believe it video system (‘‘OVS’’) framework was small entities. is unlikely that a small entity as defined established in 1996, and is one of four 64. Audio and Video Equipment by the SBA would have the financial statutorily recognized options for the Manufacturing. The SBA has classified wherewithal to become a DBS service provision of video programming the manufacturing of audio and video provider. We seek comments that have services by local exchange carriers. The equipment under in NAICS Codes data on the annual revenues and OVS framework provides opportunities classification scheme as an industry in number of employees of DBS service for the distribution of video which a manufacturer is small if it has providers. programming other than through cable less than 750 employees. Data contained 60. Satellite Master Antenna systems. Because OVS operators provide in the 2007 U.S. Census indicate that Television (SMATV) Systems, also subscription services, OVS falls within 491 establishments operated in that the SBA small business size standard industry for all or part of that year. In known as Private Cable Operators covering cable services, which is that year, 376 establishments had (PCOs). SMATV systems or PCOs are ‘‘Wired Telecommunications Carriers.’’ between 1 and 19 employees; 80 had video distribution facilities that use The SBA has developed a small between 20 and 99 employees; and 35 closed transmission paths without using business size standard for this category, had more than 100 employees. Thus, any public right-of-way. They acquire which is: All such firms having 1,500 or under the applicable size standard, a video programming and distribute it via fewer employees. According to Census majority of manufacturers of audio and terrestrial wiring in urban and suburban Bureau data for 2007, there were a total video equipment may be considered multiple dwelling units such as of 3,188 firms in this previous category small. apartments and condominiums, and that operated for the entire year. Of this 65. Description of Reporting, commercial multiple tenant units such total, 3,144 firms had employment of Recordkeeping and Other Compliance as hotels and office buildings. SMATV 999 or fewer employees, and 44 firms Requirements. The rules adopted in the systems or PCOs are now included in had employment of 1000 employees or Order will require cable operators to the SBA’s broad economic census more. Thus, under this size standard, notify their subscribers about offers of category, ‘‘Wired Telecommunications most cable systems are small and may free equipment associated with Carriers,’’ which was developed for be affected by rules adopted pursuant to encryption. The rule also requires a small wireline firms. Under this the NPRM. In addition, we note that the cable operator to notify its subscribers category, the SBA deems a wireline Commission has certified some OVS when those subscribers are subject to business to be small if it has 1,500 or operators, with some now providing charges at the end of the free equipment fewer employees. However, the data we service. Broadband service providers period. have available as a basis for estimating (‘‘BSPs’’) are currently the only 66. Steps Taken To Minimize the number of such small entities were significant holders of OVS certifications Significant Impact on Small Entities, gathered under a superseded SBA small or local OVS franchises. The and Significant Alternatives Considered. business size standard formerly titled Commission does not have financial or The RFA requires an agency to describe ‘‘Cable and Other Program employment information regarding the any significant alternatives that it has Distribution.’’ The definition of Cable entities authorized to provide OVS, considered in reaching its proposed and Other Program Distribution some of which may not yet be approach, which may include the provided that a small entity is one with operational. Thus, again, at least some following four alternatives (among $12.5 million or less in annual receipts. of the OVS operators may qualify as others): (1) The establishment of As of June 2004, there were small entities. differing compliance or reporting approximately 135 members in the 62. Computer Terminal requirements or timetables that take into Independent Multi-Family Manufacturing. ‘‘Computer terminals account the resources available to small Communications Council (IMCC), the are input/output devices that connect entities; (2) the clarification, trade association that represents PCOs. with a central computer for processing.’’ consolidation, or simplification of The IMCC indicates that, as of June The SBA has developed a small compliance or reporting requirements 2006, PCOs serve about 1 to 2 percent business size standard for this category under the rule for small entities; (3) the of the multichannel video programming of manufacturing; that size standard is use of performance, rather than design, distributors (MVPD) marketplace. 1,000 or fewer employees. According to standards; and (4) an exemption from Individual PCOs often serve 2007 Census Bureau data, there were 42 coverage of the rule, or any part thereof, approximately 3,000–4,000 subscribers, establishments in this category that for small entities. but the larger operations serve as many operated during 2007. Only 3 had more 67. As an alternative to the rules the as 15,000–55,000 subscribers. In total, as than 100 employees. Consequently, we Commission adopted, the Commission of June 2006, PCOs serve approximately estimate that all of these establishments considered leaving the current rule in 900,000 subscribers. Because these are small entities. place—with the result that no cable operators are not rate regulated, they are 63. Other Computer Peripheral operator would realize the benefits of not required to file financial data with Equipment Manufacturing. Examples of encryption—or exempting small cable the Commission. Furthermore, we are peripheral equipment in this category companies from the consumer not aware of any privately published include keyboards, mouse devices, protection rules that require encrypting financial information regarding these monitors, and scanners. The SBA has cable operators to provide certain operators. Based on the estimated developed a small business size subscribers with free set-top boxes for a number of operators and the estimated standard for this category of limited time. The Commission rejected

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leaving the rule in place because that only to the basic service tier without use equipment at no additional charge or alternative would not lead to the of a set-top box or CableCARD at the service fee for a limited period of time. benefits of reduced service calls and time of encryption the equipment The number and type of devices you are reduced cable theft. The Commission necessary to descramble or decrypt the entitled to receive and for how long will rejected exempting small cable basic service tier signals (the vary depending on your situation. If you companies from the consumer subscriber’s choice of a set-top box or are a (INSERT NAME OF CABLE BASIC protection rules because it concluded CableCARD) on up to two television sets SERVICE TIER OFFERING) customer that the protections are necessary to give without charge or service fee for two and receive the service on your TV affected consumers time to consider years from the date encryption of the without (NAME OF CABLE how to make consumer electronics basic service tier commences; and OPERATOR)-supplied equipment, you equipment (such as digital television (iii) The cable system operator offers are entitled to up to two devices for two sets) compatible with newly encrypted to its existing subscribers who subscribe years (five years if you also receive cable service. For these reasons, the to a level of service above ‘‘basic only’’ Medicaid). If you subscribe to a higher Commission concluded that basic but use a digital television or other level of service and receive (INSERT service tier encryption prohibition device with a clear-QAM tuner to NAME OF CABLE BASIC SERVICE should be relaxed. The Commission also receive only the basic service tier TIER OFFERING) on a secondary TV concluded that transitional consumer without use of a set-top box or without (NAME OF CABLE protection measures are necessary to CableCARD at the time of encryption, OPERATOR)-supplied equipment, you serve the limited number of consumers the equipment necessary to descramble are entitled to one device for one year. who currently access unencrypted cable or decrypt the basic service tier signals You can learn more about this service without the use of a set-top box. (the subscriber’s choice of a set-top box equipment offer and eligibility at 68. Federal Rules Which Duplicate, or CableCARD) on one television set (WEBPAGE ADDRESS) or by calling Overlap, or Conflict With the without charge or service fee for one (PHONE NUMBER). To qualify for any Commission’s Proposals. None. year from the date encryption of the equipment at no additional charge or basic service tier commences; and List of Subjects in 47 CFR Part 76 service fee, you must request the (iv) The cable system operator offers equipment between (DATE THAT IS 30 Administrative practice and to its existing subscribers who receive DAYS BEFORE ENCRYPTION) and Medicaid and also subscribe only to the procedure, Cable television, Equal (DATE THAT IS 120 DAYS AFTER basic service tier without use of a set- employment opportunity, Political ENCRYPTION) and satisfy all other top box or CableCARD at the time of candidates, Reporting and eligibility requirements. encryption the equipment necessary to recordkeeping requirements. (vi) The cable system operator notifies descramble or decrypt the basic service Federal Communications Commission. tier signals (the subscriber’s choice of a its subscribers who have received Marlene H. Dortch, set-top box or CableCARD) on up to two equipment described in paragraphs Secretary. television sets without charge or service (a)(1)(ii) through (iv) of this section at least 30 days, but no more than 60 days, Rule Changes fee for five years from the date encryption of the basic service tier before the end of the free device For the reasons discussed in the commences; transitional period that the transitional preamble, the Federal Communications (v) The cable system operator notifies period will end. This notification must Commission amends 47 CFR part 76 as its existing subscribers of the state: follows: availability of the offers described in You currently receive equipment paragraphs (ii) through (iv) of this necessary to descramble or decrypt the PART 76—MULTICHANNEL VIDEO section at least 30 days prior to the date basic service tier signals (either a set-top AND CABLE TELEVISION SERVICE encryption of the basic service tier box or CableCARD) free of charge. Effective with the (MONTH/YEAR) ■ 1. The authority citation for part 76 commences and makes the offers billing cycle, (NAME OF CABLE continues to read as follows: available for at least 30 days prior to and 120 days after the date encryption of the OPERATOR) will begin charging you for Authority: 47 U.S.C. 151, 152, 153, 154, basic service tier commences. The the equipment you received to access 301, 302, 302a, 303, 303a, 307, 308, 309, 312, notification to subscribers must state: (INSERT NAME OF CABLE BASIC 315, 317, 325, 339, 340, 341, 503, 521, 522, SERVICE TIER OFFERING) when 531, 532, 534, 535, 536, 537, 543, 544, 544a, On (DATE), (NAME OF CABLE 545, 548, 549, 552, 554, 556, 558, 560, 561, OPERATOR) will start encrypting (NAME OF CABLE OPERATOR) started 571, 572, 573. (INSERT NAME OF CABLE BASIC encrypting those channels on your cable SERVICE TIER OFFERING) on your system. The monthly charge for the ■ 2. Amend § 76.630 by revising cable system. If you have a set-top box, (TYPE OF DEVICE) will be (AMOUNT paragraph (a) and revising section notes digital transport adapter (DTA), or a OF CHARGE). 1 and 2 and removing notes 3 and 4. retail CableCARD device connected to (2) Requests for waivers of this The revisions read as follows: each of your TVs, you will be unaffected prohibition must demonstrate either a § 76.630 Compatibility with consumer by this change. However, if you are substantial problem with theft of basic electronics equipment. currently receiving (INSERT NAME OF tier service or a strong need to scramble (a) Cable system operators shall not CABLE BASIC SERVICE TIER basic signals for other reasons. As part scramble or otherwise encrypt signals OFFERING) on any TV without of this showing, cable operators are delivered to a subscriber on the basic equipment supplied by (NAME OF required to notify subscribers by mail of service tier. CABLE OPERATOR), you will lose the waiver requests. The notice to (1) This prohibition shall not apply in ability to view any channels on that TV. subscribers must be mailed no later than systems in which: If you are affected, you should contact 30 calendar days from the date the (i) No encrypted signals are carried (NAME OF CABLE OPERATOR) to request for waiver was filed with the using the NTSC system; and arrange for the equipment you need to Commission, and cable operators must (ii) The cable system operator offers to continue receiving your services. In inform the Commission in writing, as its existing subscribers who subscribe such case, you are entitled to receive soon as possible, of that notification

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date. The notification to subscribers and address of the local franchising • Agency Web site: You can view must state: authority. supporting documents on our Web site * * * * * at http://www.fws.gov/ventura/. On (date of waiver request was filed • with the Commission), (cable operator’s [FR Doc. 2012–27350 Filed 11–8–12; 8:45 am] Our office: Call 805–644–1766 to name) filed with the Federal BILLING CODE 6712–01–P make an appointment, during normal Communications Commission a request business hours, to view the documents, for waiver of the rule prohibiting comments, and materials in person at scrambling of channels on the basic tier the U.S. Fish and Wildlife Service, DEPARTMENT OF THE INTERIOR of service. 47 CFR 76.630(a). The Ventura Fish and Wildlife Office, 2493 Portola Road, Suite B, Ventura, CA request for waiver states (a brief Fish and Wildlife Service summary of the waiver request). A copy 93003–7726. Alternatively, a limited number of of the request for waiver shall be 50 CFR Part 17 available for public inspection at (the CD–ROMs and hard copies of the final address of the cable operator’s local SEIS are available from the U.S. Fish [FWS–R8–FHC–2011–0046]; [FF08E00000– and Wildlife Service, Ventura Fish and place of business). FXES11130800000D2–123] Wildlife Office, 2493 Portola Road, Individuals who wish to comment on Suite B, Ventura, CA 93003–7726. this request for waiver should mail RIN 1018–AX51 FOR FURTHER INFORMATION CONTACT: comments to the Federal Lilian Carswell, at the above Ventura Communications Commission by no Endangered and Threatened Wildlife street address, by telephone (805–612– later than 30 days from (the date the and Plants; Termination of the 2793), or by electronic mail notification was mailed to subscribers). Southern Sea Otter Translocation ([email protected]). Persons who Those comments should be addressed to Program; Final Supplemental use a telecommunications device for the the: Federal Communications Environmental Impact Statement on deaf may call the Federal Information Commission, Media Bureau, the Translocation of Southern Sea Relay Services at 800–877–8339. Washington, DC 20554, and should Otters SUPPLEMENTARY INFORMATION: We include the name of the cable operator AGENCY: Fish and Wildlife Service, announce the availability of our final to whom the comments are applicable. Interior. Individuals should also send a copy of Supplemental Environmental Impact ACTION: Notice of availability. their comments to (the cable operator at Statement on the Translocation of Southern Sea Otters (final SEIS). The its local place of business). SUMMARY: We, the U.S. Fish and final SEIS evaluates options for Wildlife Service (Service), announce the Cable operators may file comments in continuing, revising, or terminating the availability of our final Supplemental reply no later than 7 days from the date southern sea otter translocation program Environmental Impact Statement on the subscriber comments must be filed. (52 FR 29754, Aug. 11, 1987). The Translocation of Southern Sea Otters * * * * * document describes the proposed action (final SEIS). The final SEIS evaluates and alternatives under consideration Note 1 to § 76.630: 47 CFR 76.1621 options for continuing, revising, or and discloses the direct, indirect, and contains certain requirements pertaining to a terminating the southern sea otter cumulative environmental effects of cable operator’s offer to supply subscribers translocation program, which was each of the alternatives. with special equipment that will enable the initiated in 1987. The purpose of the simultaneous reception of multiple signals. program was to achieve a primary Background recovery action for the southern sea Note 2 to § 76.630: 47 CFR 76.1622 The final SEIS reevaluates the effects contains certain requirements pertaining to otter: to create an established of the southern sea otter translocation the provision of a consumer education population at San Nicolas Island plan, as described in the U.S. Fish and program on compatibility matters to sufficient to repopulate other areas of Wildlife Service’s 1987 environmental subscribers. the range should a catastrophic event impact statement on our program for affect the mainland population. The translocation of southern sea otters (May ■ 3. Section 76.1603 is amended by document describes the proposed action 8, 1987, 52 FR 17486). Using revising paragraph (d) to read as and alternatives under consideration information obtained over the decades follows: and discloses the direct, indirect, and since the program’s implementation, we cumulative environmental effects of evaluate the impacts of alternatives to § 76.1603 Customer service—rate and each of the alternatives. service changes. the current translocation program, DATES: We will execute a Record of including termination or revisions to the * * * * * Decision no sooner than 30 days after program. The need for action stems from (d) A cable operator shall provide the date the Environmental Protection our inability to meet the goals of the written notice to a subscriber of any Agency publishes its notice of southern sea otter translocation increase in the price to be charged for availability of the final SEIS in the program. Contrary to the primary the basic service tier or associated Federal Register. recovery objective of the program, the equipment at least 30 days before any ADDRESSES: The final SEIS and other translocation of sea otters to San Nicolas proposed increase is effective. If the documents are available in electronic Island has not resulted in an established equipment is provided to the consumer format at the following places: population sufficient to repopulate without charge pursuant to § 76.630, the • Federal eRulemaking Portal: Go to other areas of the range should a cable operator shall provide written http://www.regulations.gov. In the catastrophic event affect the mainland notice to the subscriber no more than 60 search field, enter FWS–R8–FHC–2011– population. Additionally, maintenance days before the increase is effective. The 0046, which is the docket number. Then of a management zone has proven to be notice should include the price to be click on the Search button. On the more difficult than anticipated and charged, and the date that the new resulting screen, you may view hinders or may prevent recovery of the charge will be effective, and the name documents associated with the docket. southern sea otter.

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We consider six alternatives, comments from interested individuals Environmental Policy Act of 1969 (40 including a No Action Alternative. and organizations. CFR 1506.6). Alternative 1 resumes implementation Continuing efforts to resolve Dated: November 1, 2012. of the 1987 southern sea otter stakeholder concerns forestalled Alexandra Pitts, translocation program as originally publication of a final SEIS for several Acting Regional Director, Pacific Southwest defined. Alternative 2 resumes years. On September 30, 2009, two Region. implementation of the 1987 southern environmental groups filed suit against [FR Doc. 2012–27310 Filed 11–8–12; 8:45 am] sea otter translocation program but the Service under provisions of the reduces the size of the management Administrative Procedure Act, alleging BILLING CODE 4310–55–P zone. Alternatives 3A, 3B, and 3C allow that we had unreasonably delayed a for the natural range expansion of decision on the translocation program. southern sea otters through termination Publication of a final SEIS on the DEPARTMENT OF COMMERCE of the 1987 translocation program, translocation program is part of the including its associated translocation settlement agreement we reached with National Oceanic and Atmospheric zone and management zone, but differ plaintiffs on November 23, 2010. Administration in the actions to be taken with sea otters In order to ensure that our analysis existing in these zones upon reflects current conditions, we revised 50 CFR Part 622 termination of the program. Alternative the draft SEIS. We announced the 3A requires the short-term removal of availability of a revised draft SEIS and [Docket No. 120417412–2412–01] sea otters from both the management a proposed rule to implement the zone and the translocation zone before preferred alternative on August 26, 2011 RIN 0648–BB90 natural range expansion is allowed. (76 FR 53381). Appendix G to the Alternative 3B requires the short-term revised draft SEIS included a list of Fisheries of the Caribbean, Gulf of removal of sea otters from the commenters, summaries of comments Mexico, and South Atlantic; Reef Fish translocation zone only. The Service’s received on the draft SEIS, and our Fishery of the Gulf of Mexico; Gray preferred alternative (Alternative 3C) is responses to those comments. The Triggerfish Management Measures to allow for the natural range expansion comment period for the revised draft AGENCY: of sea otters through termination of the SEIS was originally scheduled to end on National Marine Fisheries 1987 translocation program and to allow October 24, 2011 (76 FR 53381). On Service (NMFS), National Oceanic and sea otters existing in the former November 4, 2011, we announced a Atmospheric Administration (NOAA), translocation and management zones to reopening of the comment period until Commerce. remain there. November 21, 2011 (76 FR 68393), ACTION: Temporary rule; interim We have afforded other government based on a request for a 45-day measures extended. agencies and the public extensive extension by the California Sea Urchin SUMMARY: NMFS issues this temporary opportunity to participate in the Commission. We were unable to grant rule to extend the expiration date of preparation of this EIS. On July 27, the full 45-day extension because we interim measures to reduce overfishing 2000, we published in the Federal required sufficient time to consider of gray triggerfish in the Gulf of Mexico Register a notice of intent to prepare a public comments and to revise the SEIS (Gulf) implemented by a temporary rule SEIS on the southern sea otter as appropriate while still meeting court published by NMFS on May 14, 2012. translocation program (65 FR 46172). settlement deadlines; however, the This temporary rule extends the The notice of intent announced that reopened comment period allowed us to reduced commercial quota (commercial public scoping meetings would be held accept public comments for 18 annual catch target (ACT)), commercial on August 15, 2000, in Santa Barbara, additional days. We accepted oral and and recreational annual catch limits California, and on August 17, 2000, in written testimony during public (ACLs), and recreational ACT; and the Monterey, California. In April 2001, we hearings held in Ventura, California, on revised recreational accountability published a scoping report and September 27, 2011; Santa Barbara, measures (AMs) for gray triggerfish, as distributed it to scoping meeting California, on October 4, 2011; and requested by the Gulf of Mexico Fishery participants and other interested parties Santa Cruz, California, on October 6, Management Council (Council). The (the scoping report is included as 2011. Approximately 190 people intended effect of this temporary rule is Appendix E to the final SEIS). attended the public hearings, and 68 to reduce overfishing of the gray provided testimony. We announced the availability of the triggerfish resource in the Gulf while the draft SEIS and the beginning of the In the 78 days during which Council develops permanent public comment period on October 7, comments were accepted, we received management measures. 2005 (70 FR 58737). The comment 6,843 comment letters, postcards, and period was originally scheduled to end emails from interested individuals and DATES: The expiration date for the on January 5, 2006 (70 FR 58737). On organizations. Among the comment interim rule published at 77 FR 28308, December 30, 2005, we extended the letters were 5 petitions with 12,514 May 14, 2012, is extended from comment period to March 6, 2006 (70 signatories. November 10, 2012, through May 15, FR 77380), based on requests for a 30- Appendix G to the final SEIS includes 2013, unless NMFS publishes a day or 60-day extension of the comment a list of commenters, summaries of superseding document in the Federal period by fishing and environmental comments received on the revised draft Register. groups. We accepted oral and written SEIS, and our responses to those ADDRESSES: Electronic copies of testimony during public hearings held comments. documents supporting this temporary in Santa Barbara, California, on rule, which include an environmental Authority November 1, 2005, and Monterey, assessment (EA) and a regulatory California, on November 3, 2005. During This notice is provided pursuant to flexibility analysis, may be obtained the 5-month comment period, we Fish and Wildlife Service regulations for from the Southeast Regional Office Web received approximately 20,000 implementing the National site at http://sero.nmfs.noaa.gov.

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FOR FURTHER INFORMATION CONTACT: address the overfishing on a permanent bag limit should have been Peter Hood, telephone: 727–824–5305 or basis. implemented to avoid any closures. email: [email protected]. Amendment 37 is scheduled to be Response: In evaluating long-term SUPPLEMENTARY INFORMATION: The reef implemented early in the 2013 fishing measures to reduce the recreational fish fishery of the Gulf is managed year. harvest of gray triggerfish in Amendment 37, the Council is under the Fishery Management Plan for Comments and Responses the Reef Fish Resources of the Gulf of evaluating reduced recreational bag Mexico (FMP). The FMP was prepared Section 305(c)(3)(B) of the Magnuson- limits. However, their analyses indicate Stevens Act requires that the public has by the Council and is implemented that even if the bag limit were reduced an opportunity to comment on interim through regulations at 50 CFR part 622 to 1-fish per person per day from the measures after the regulation is under the authority of the Magnuson- current 20-fish reef fish aggregate bag published and the Council is actively Stevens Fishery Conservation and limit, some type of seasonal closure is preparing a plan amendment to address Management Act (Magnuson-Stevens needed to reduce harvest consistent overfishing on a permanent basis. Act). The Magnuson-Stevens Act with reductions needed for the Therefore, NMFS solicited comments in provides the legal authority for the rebuilding plan. The Council is the May 14, 2012, final temporary rule. promulgation of interim regulations evaluating a combination of these NMFS received comments from a total under section 305(c) (16 U.S.C. 1855(c)). measures in Amendment 37 to the FMP. of 11 entities on the final temporary Comment 4: The 2011 SEDAR gray Section 305(c)(2) of the Magnuson- rule. The following is a summary of the triggerfish update stock assessment did Stevens Act provides the Council the substantive comments NMFS received not account for changes in gray authority to request interim measures, if and NMFS’ respective responses. triggerfish fishing as a result of the necessary, to reduce overfishing. On Similar comments have been grouped increase in the minimum size limit and April 19, 2012, the Council requested together. the requirement to use circle hooks. that NMFS implement a temporary rule Comment 1: Personal observations do Response: The 2011 SEDAR update to reduce overfishing of gray triggerfish not support the stock assessment assessment did account for the increase in the Gulf while the Council and NMFS findings that the stock is overfished and from 12-inches (30.5 cm), total length, to develop Amendment 37 to the FMP. undergoing overfishing. Therefore, there 14-inches (35.6 cm), fork length. This Amendment 37 will contain permanent is no reason for the temporary rule. change was noted in the regulatory measures to end overfishing of the gray Response: Gray triggerfish are known history section in the final 2011 SEDAR triggerfish stock. On May 14, 2012, to be highly site specific and so it is update assessment report. The effects of NMFS published the final temporary possible that gray triggerfish abundance the size limit change were reflected in rule (77 FR 28308) to implement is greater in some areas of the Gulf than length data from fishery-dependent measures to reduce overfishing of gray in others. However, both the 2006 sampling programs after August 4, 2008, triggerfish in the Gulf and requested benchmark and 2011 update Southeast when Amendment 30A to the FMP public comment. The interim measures Data, Assessment, and Review (SEDAR) became effective and these measures implemented revised commercial and assessments of the gray triggerfish stock were implemented (73 FR 38139, July 3, recreational ACLs and ACTs and revised used data from a variety of sources 2008). Although the effects of circle the AMs for the recreational sector. throughout the Gulf. Both of these hooks on gray triggerfish fishing were Through the final temporary rule, the assessments, which are considered the not specifically examined in the 2011 commercial sector ACL was reduced to best available science, indicate the stock update assessment, the 2011 SEDAR 64,100 lb (29,075 kg), round weight, and size is too low (overfished) and that too update stock assessment showed the commercial ACT (commercial quota) many fish are being caught and landed declines in both the commercial and was reduced to 60,900 lb (27,624 kg), (overfishing). The Magnuson-Stevens recreational harvest starting in 2005, round weight. The recreational sector Act requires the Council and NMFS to well before the circle hook requirement ACL was reduced to 241,200 lb (109,406 end overfishing and allow the stock to went into effect on June 1, 2008. kg), round weight, and the recreational recover; therefore, the Council and Therefore, other factors are responsible ACT was reduced to 217,100 (98,475 NMFS are obligated to revise the gray for the declining gray triggerfish stock. kg), round weight. Additionally, the triggerfish rebuilding plan to achieve In addition, differences between catch- temporary rule established an in-season these objectives. per-unit-effort estimates between the AM for the gray triggerfish recreational Comment 2: Personal observations 2011 SEDAR update assessment and the sector that prohibits the recreational support that gray triggerfish abundances 2006 SEDAR benchmark assessment did harvest of gray triggerfish (a recreational are low, but the cause of the reduction not vary by much, suggesting the change sector closure) after the recreational in abundance is not due to overfishing. to circle hooks has had little effect on ACT is reached or projected to be Reductions in abundance are due to the gray triggerfish fishing. reached. number of red snapper feeding on Comment 5: The gray triggerfish The Council requested an extension of juvenile reef fish, including gray commercial sector should be closed the interim rule on August 23, 2012, to triggerfish. until the gray triggerfish stock recovers. ensure that management measures Response: The 2011 SEDAR update Response: The temporary rule reduces remain in effect for gray triggerfish to assessment indicated that for 2005– overfishing of the gray triggerfish stock reduce overfishing while more 2009, gray triggerfish recruitment has while the Council develops a rebuilding permanent measures are developed been less than average. However, the plan in Amendment 37. In rebuilding through Amendment 37. Section reason for the reduced recruitment is overfished stocks, the Magnuson- 305(c)(3)(B) of the Magnuson-Stevens currently unknown. At this time, there Stevens Act requires that regulations Act allows for interim measures to be is no evidence to support that low gray shall ‘‘allocate both overfishing extended for one additional period of triggerfish recruitment is a result of red restrictions and recovery benefits fairly 186 days provided that the public has snapper predation. and equitably among sectors of the had an opportunity to comment on the Comment 3: Rather than closing gray fishery’’ (Magnuson-Stevens Act section interim measures and the Council is triggerfish recreational harvest when the 304(e)(4)(B)). The action proposed in the actively preparing a plan amendment to ACL is reached, a reduced recreational comment would place all overfishing

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restrictions to the commercial sector, opportunity for public comment would mortality cap at 3,165 mt. These and as the stock recovers, allocate these be contrary to the public interest. This specifications promote the utilization benefits to the recreational sector. Thus, rule would continue interim measures and conservation of the butterfish this action would not be fair and implemented by the May 14, 2012, final resource. equitable and would not conform to the temporary rule, for not more than an DATES: Effective on November 8, 2012. Magnuson-Stevens Act. additional 186 days beyond the current Comments must be received by Additionally, the current allocation expiration date of November 10, 2012. November 26, 2012. between the commercial and The conditions prompting the initial recreational sector is 29 percent and 71 temporary rule still remain, and more ADDRESSES: Copies of the revised 2012 percent, respectively. Given the needed permanent measures to be completed specifications document, including the reduction in gray triggerfish harvest through Amendment 37 have not yet Environmental Assessment (EA), is from 2011 levels to 2012 levels is been finalized. Failure to extend these available from John K. Bullard, approximately 50 percent, closing the interim measures, while NMFS finalizes Northeast Regional Administrator, commercial sector would not achieve the more permanent measures in National Marine Fisheries Service, 55 the needed reduction in harvest that Amendment 37, would result in Great Republic Drive, Gloucester, MA would allow the stock to recover by additional overfishing of the Gulf gray 01930. This document is also accessible 2017, the end year of the 10-year gray triggerfish stock, which is contrary to via the Internet at http:// triggerfish rebuilding plan. Therefore, the public interest and in violation of www.nero.noaa.gov. even with an established commercial National Standard 1 of the Magnuson- You may submit comments, identified closure, recreational measures would Stevens Act. by NOAA–NMFS–2012–0209, by any still need to be implemented for the For the aforementioned reasons, the one of the following methods: stock to recover within the allotted time AA also finds good cause under 5 U.S.C. • Electronic Submission: Submit all of the rebuilding plan. 553(d)(3) to waive the 30-day delay in electronic public comments via the Classification effectiveness of this rule. Federal e-Rulemaking Portal Authority: 16 U.S.C. 1801 et seq. www.regulations.gov. To submit The Administrator, Southeast Region, comments via the e-Rulemaking Portal, NMFS, (RA) has determined that the Dated: November 6, 2012. first click the ‘‘submit a comment’’ icon, interim measures this temporary rule Alan D. Risenhoover, then enter NOAA–NMFS–2012–0209 in extends are necessary for the Director, Office of Sustainable Fisheries, the keyword search. Locate the conservation and management of the performing the functions and duties of the document you wish to comment on Gulf gray triggerfish stock, until more Deputy Assistant Administrator for from the resulting list and click on the permanent measures are implemented, Regulatory Programs, National Marine Fisheries Service. ‘‘Submit a Comment’’ icon on the right and is consistent with the Magnuson- of that line. Stevens Act and other applicable laws. [FR Doc. 2012–27444 Filed 11–8–12; 8:45 am] • Mail to NMFS, Northeast Regional The Council and NMFS are developing BILLING CODE 3510–22–P Office, 55 Great Republic Dr, Gloucester, Amendment 37 to the FMP to establish MA 01930. Mark the outside of the long-term measures to end the envelope ‘‘Comments on Interim Final overfishing of Gulf gray triggerfish and DEPARTMENT OF COMMERCE 2012 Butterfish Specifications.’’ rebuild the stock. Amendment 37 and • its associated regulations are still being National Oceanic and Atmospheric Fax: (978) 281–9135, Attn: Aja implemented and are not expected to Administration Szumylo. become effective until the 2013 fishing Instructions: Comments must be year. 50 CFR Part 648 submitted by one of the above methods This temporary rule has been [Docket No. 120917459–2591–01] to ensure that they are received, determined to be not significant for documented, and considered by NMFS. purposes of E.O. 12866. RIN 0648–BC57 Comments sent by any other method, to This temporary rule is exempt from any other address or individual, or Fisheries of the Northeastern United the procedures of the Regulatory received after the end of the comment States; Atlantic Mackerel, Squid, and Flexibility Act because the rule is issued period, may not be considered. All Butterfish Fisheries; Specifications without opportunity for prior notice and comments received are a part of the and Management Measures comment. public record and will generally be An EA was prepared for the interim AGENCY: National Marine Fisheries posted for public viewing on measures contained in the May 14, Service (NMFS), National Oceanic and www.regulations.gov without change. 2012, final temporary rule (77 FR Atmospheric Administration (NOAA), All personal identifying information 28308). The EA analyzed the impacts of Commerce. (e.g., name, address, etc.) submitted reduced harvest through the 2012 ACTION: Interim final rule. voluntarily by the sender will be fishing year, which includes the impacts publicly accessible. Do not submit related to extending the interim rule. SUMMARY: NMFS is implementing confidential business information, or Therefore, the impacts of continuing the revised 2012 specifications for the otherwise sensitive or protected interim measures through this extension butterfish fishery, which is managed as information. NMFS will accept have already been considered. Copies of part of the Atlantic Mackerel, Squid, anonymous comments (enter ‘‘N/A’’ in the EA are available from NMFS (see and Butterfish Fishery Management the required fields if you wish to remain ADDRESSES). Plan. This action raises the butterfish anonymous). Attachments to electronic The Assistant Administrator for acceptable biological catch (ABC) to comments will be accepted in Microsoft Fisheries, NOAA (AA) finds good cause 4,200 mt (from 3,622 mt), and specifies Word or Excel, WordPerfect, or Adobe under 5 U.S.C. 553(b)(B) to waive prior the butterfish annual catch target (ACT) PDF file formats only. Comments on this notice and opportunity for public at 3,780 mt, the domestic annual harvest interim final rule will be addressed in comment on this temporary rule (DAH) and domestic annual processing the final rule for 2013 Specifications extension. Providing prior notice and (DAP) at 872 mt, and the butterfish and Management Measures for the

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Atlantic Mackerel, Squid, and Butterfish catchability) to develop a range of likely landings and the butterfish cap are Fishery Management Plan. stock biomasses that would be tracked in parallel such that all landings FOR FURTHER INFORMATION CONTACT: Aja consistent with recent survey results count against the DAH for quota Szumylo, Fishery Policy Analyst, 978– and observed butterfish catch. The monitoring, while all butterfish catch 281–9195, fax 978–281–9135. NEFSC also examined a range of fishing (landings and discards) by vessels that SUPPLEMENTARY INFORMATION: mortalities that would result from these land over 2,500 lb (1.13 mt) of longfin biomass estimates. The SSC used the squid count against the butterfish Background NEFSC analysis, along with guidance mortality cap. The Council requested At the August 2012 Mid-Atlantic (Patterson, 1992) that suggests that 200 mt of the current DAH be Fishery Management Council (Council) maintaining a natural mortality/fishing moved to the butterfish mortality cap to meeting, several longfin squid industry mortality ratio of 67 percent for small balance the use of butterfish in the members expressed concern that the pelagic species, to develop a proxy mortality cap and the directed fishery, current 2012 acceptable biological catch overfishing limit (OFL) for butterfish. while constraining overall catch within (ABC) for butterfish (3,622 mt) was too Consistent with the 2010 butterfish the ABC. Current landing trends suggest conservative, and that the butterfish assessment, the SSC assumed a high that total 2012 butterfish landing should mortality cap on the longfin squid level of natural mortality (M = 0.8) and not exceed 650 mt, thus transferring an fishery derived from this ABC may close applied the 67-percent ratio to result in additional 200 mt from the DAH into the longfin squid fishery prior to the a fishing mortality of F = 0.536, which the butterfish cap would allow for end of the 2012 fishing year. In response the SSC used as a proxy maximum additional longfin squid landings to this concern, and in light of the fishing mortality rate threshold for without constraining butterfish Council’s Scientific and Statistical butterfish. In the NEFSC analysis, a landings. catch of 16,800 mt would only lead to Committee’s (SSC) recommended NMFS found that there is sufficient fishing mortality rates higher than F = butterfish ABC for the 2013 fishing year scientific justification for the Council’s 0.536 (i.e., rates consistent with (8,400 mt), the Council requested that recommendations, and is implementing overfishing based on the maximum the SSC reconsider its butterfish ABC the revised specifications as fishing mortality rate threshold proxy) recommendation for 2012. The SSC met recommended. The authority for this under very extreme assumptions. The on September 13, 2012, and revised its rulemaking is 50 CFR 648.22(e), which SSC therefore adopted 16,800 mt as a 2012 butterfish ABC recommendation to allows the Regional Administrator to proxy OFL. The SSC buffered the proxy 4,200 mt based on the information that adjust specifications during the fishing OFL by 50 percent to reach the supported their 2013 ABC year, in consultation with the Council, butterfish ABC of 8,400 mt. Its recommendation, and noted that the by publishing notification in the justification for this buffer noted that Federal Register. The allocations for additional mortality at the end of the the short life history of butterfish gives 2012 fishing year should not result in Research Set-Aside (RSA) and joint limited time for management to respond venture processing (JVP) remain as overfishing. The recommendation of to adverse patterns, that recruitment of 4,200 mt represents the projected specified in the interim final butterfish butterfish is highly variable and specifications (77 FR 16472; March 21, butterfish mortality on November 1, uncertain, that the stock status of 2012 (2,800 mt), plus the prorated 2012). The total allowable level of butterfish is unknown, and that foreign fishing (TALFF) for butterfish is mortality that would have been butterfish are susceptible to allocated for the months of November only specified to address bycatch by environmental and ecosystem foreign fleets targeting mackerel TALFF. and December (700 mt per month) if the variability, in particular inter-annual SSC had recommended a 2012 ABC of Because there was no mackerel TALFF × variability in natural mortality. specified in the final 2012 specifications 8,400 mt (2,800 mt + (700 mt 2) = Based on the SSC’s revised 4,200 mt). for mackerel, butterfish TALFF is also recommendation, the Council met on set at zero. A detailed summary of the SSC’s September 14, 2012, and recommended rationale for its 2013 butterfish ABC an increase of the butterfish ABC and TABLE 1—INTERIM FINAL SPECIFICA- recommendation is available in its May annual catch limit (ACL) to 4,200 mt for TIONS, IN METRIC TONS (MT), FOR 2012 Report (available, along with other the remainder of the 2012 fishing year materials from the SSC discussion, at: (until December 31, 2012). The Council BUTTERFISH FOR THE 2012 FISHING http://www.mafmc.org/ recommended maintaining the current YEAR meeting_materials/SSC/2012-05/ 10-percent buffer for management SSC_2012_05.htm), and will be uncertainty and set an annual catch Specifications Butterfish discussed in the documentation for the target (ACT) of 3,780 mt (a 520-mt OFL ...... (1) 2013 MSB specifications increase over the current ACT of 3,260 ABC ...... 4,200 recommendations. It is summarized mt). ACL ...... 4,200 below because of its relevance to this The Council also recommended re- ACT ...... 3,780 action. specifying the butterfish mortality cap at RSA ...... 15 Because of the uncertainty in the most 3,165 mt, and the butterfish domestic DAH/DAP ...... 872 recent butterfish stock assessment, on annual harvest (DAH) and domestic JVP ...... 0 April 6, 2012, the Council requested annual processing (DAP) at 872 mt. The TALFF ...... 0 that NMFS Northeast Fisheries Science current butterfish mortality cap on the Butterfish Mortality Cap ...... 3,165 Center (NEFSC) offer additional analysis longfin squid fishery is 2,445 mt, and 1 Unknown. of the butterfish stock to aid the SSC in the Council proposed using the entire the ABC setting process for the 2013 520 mt added to the ACT to increase the Classification fishing year. The NEFSC analysis (May butterfish mortality cap, as well as The Administrator, Northeast Region, 2, 2012, also available with the SSC transferring 200 mt from the current NMFS, determined that these meeting report) applied ranges of a DAH (1,072 mt) to the cap, for a total specifications are necessary for the number of different factors (such as increase of 720 mt (2,445 mt + 520 mt conservation and management of the natural mortality and survey + 200 mt = 3,165 mt). Butterfish butterfish fishery and that they are

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consistent with the Magnuson-Stevens August 16, 2012. The SSC met to review implementation of this rule could Fishery Conservation and Management this request on September 13, 2012, prevent the harvest of a significant Act and other applicable laws. which was the earliest possible date that amount of longfin squid quota. With The Assistant Administrator for they could meet given public notice current squid prices at $1 per pound, Fisheries, NOAA, finds good cause requirements necessary to schedule and the lost revenue from such a closure (up under section 553(b)(B) of the convene SSC meetings. Similarly, the to 1,200 mt of the remaining 10,622 mt Administrative Procedure Act to waive Council met to consider the SSC’s of longfin squid quota—the average the requirement that NMFS provide revised recommendation and monthly squid landings for the 2012 prior notice of this rule and an recommend the adjustment to the fishing year) could amount to $2.6 opportunity for comment because they butterfish ABC at the earliest possible million, which would negate any benefit are contrary to the public interest. date given public notice requirements, of implementing this rule. As noted Allowing time for prior notice and which was September 14, 2012. above, allowing the longfin squid public comment would be contrary to Allowing time for prior public notice fishery to extend its fishing activity the public interest because of the and comment in addition to that offered through the end of the 2012 fishing year unnecessary economic harm it would through the Council process would will not result in harm to the butterfish cause to the longfin squid fishery. The further delay the use of available population. Moreover, the fishing interim final 2012 butterfish scientific information to increase the entities affected by this rule need not specifications will aid the longfin squid butterfish mortality cap on the longfin change their practice or gear, or make fishery because the rule will increase squid fishery, which negates direct any other modifications to come into the butterfish mortality cap in that benefits to the longfin squid fleet. compliance with this action. These fishery to 3,165 mt (a 720-mt increase The Assistant Administrator for fishing vessels can continue to fish as from status quo). Recently available data Fisheries also finds good cause under they do now without any change after indicate that the butterfish biomass has section 553(d) of the Administrative this rule goes into effect. sufficiently increased to allow NMFS to Procedure Act to waive the 30-day delay The Council prepared an EA for the increase the butterfish mortality cap in effectiveness for this action. 2012 specifications, and the NOAA without risking harm to the species. Increasing the butterfish mortality cap Assistant Administrator for Fisheries This action did not allow for prior should allow for the longfin squid concluded that there will be no public comment because the request for fishery to operate for the duration of the significant impact on the human Council reconsideration of the 2012 2012 fishing year. Longfin squid migrate environment as a result of this rule. A butterfish specifications, the SSC’s throughout their range and have copy of the EA is available upon request scientific review process, and the sporadic availability. The fleet is quick (see ADDRESSES). determination could not have been to target longfin squid aggregations This interim final rule has been completed any earlier, due to the when they do appear, and is capable of determined to be not significant for inherent time constraints associated landing over 550 mt in a single week. purposes of Executive Order 12866. with the process. While the information Analysis of this year’s fishing activity This rule is exempt from the supporting this change became available indicates that longfin squid was procedures of the Regulatory Flexibility during the specifications setting process particularly abundant this spring and Act to prepare a regulatory flexibility for the 2013 fishing year in May 2012, summer, and historical availability analysis because the rule is issued the need to use this information to patterns suggest that longfin squid without opportunity for prior public adjust the 2012 butterfish specifications abundance could remain high until the comment. only became apparent in August 2012, close of the fishing year on December Authority: 16 U.S.C. 1801 et seq. after high squid availability and rapid 31, 2012. Only 11,598 mt of the 22,220 utilization of the lower (2,445-mt) mt longfin squid quota has been Dated: November 5, 2012. butterfish mortality cap made the harvested as of October 31, 2012, Paul N. Doremus, possibility of a Trimester III longfin meaning that 52.1 percent of the quota Deputy Assistant Administrator for squid closure imminent. The request to remains to be harvested during the final Operations, National Marine Fisheries consider the applicability of the SSC’s 2 months of the fishing year. Closing the Service. 2013 butterfish ABC recommendation to longfin squid fishery during the 30-day [FR Doc. 2012–27335 Filed 11–8–12; 8:45 am] the 2012 fishing year was made on delay period prior to the BILLING CODE 3510–22–P

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Proposed Rules Federal Register Vol. 77, No. 218

Friday, November 9, 2012

This section of the FEDERAL REGISTER Privacy: The FAA will post all composite empennage and control contains notices to the public of the proposed comments it receives, without change, surfaces. The Model EMB–550 airplane issuance of rules and regulations. The to http://www.regulations.gov/, is designed for 8 passengers, with a purpose of these notices is to give interested including any personal information the maximum of 12 passengers. It is persons an opportunity to participate in the commenter provides. Using the search equipped with two Honeywell rule making prior to the adoption of the final rules. function of the docket Web site, anyone HTF7500–E medium bypass ratio can find and read the electronic form of turbofan engines mounted on aft all comments received into any FAA fuselage pylons. Each engine produces DEPARTMENT OF TRANSPORTATION docket, including the name of the approximately 6,540 pounds of thrust individual sending the comment (or for normal takeoff. The primary flight Federal Aviation Administration signing the comment for an association, controls consist of hydraulically business, labor union, etc.). DOT’s powered fly-by-wire elevators, aileron 14 CFR Part 25 complete Privacy Act Statement can be and rudder, controlled by the pilot or found in the Federal Register published copilot sidestick. [Docket No. FAA–2012–1200; Notice No. 25– The Model EMB–550 airplane will 12–07–SC] on April 11, 2000 (65 FR 19477–19478), as well as at http://DocketsInfo.dot.gov/. use a hydrophobic coating on the Special Conditions: Embraer S.A., Docket: Background documents or windshield in lieu of windshield Model EMB–550 Airplane; Hydrophobic comments received may be read at wipers. The existing regulation, Title 14, Coatings in Lieu of Windshield Wipers http://www.regulations.gov/ at any time. Code of Federal Regulations (14 CFR) Follow the online instructions for 25.773(b)(1), requires a means to AGENCY: Federal Aviation accessing the docket or go to the Docket maintain a sufficiently clear portion of Administration (FAA), DOT. Operations in Room W12–140 of the the windshield for both pilots to have ACTION: Notice of proposed special West Building Ground Floor at 1200 sufficiently extensive view along the conditions. New Jersey Avenue SE., Washington, flight path during precipitation conditions in heavy rain at speeds up to SUMMARY: This action proposes special DC, between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. 1.5 VSR1. The heavy rain and high speed conditions for the Embraer S.A., Model conditions in the rule do not necessarily FOR FURTHER INFORMATION CONTACT: Paul EMB–550 airplane. This airplane will represent the limiting condition for this Bernado, FAA, Airplane and Flight have a novel or unusual design new technology. For example, airflow Crew Interface Branch, ANM–111, feature(s) associated with hydrophobic over the windshield may be necessary to Transport Airplane Directorate, Aircraft coatings. The applicable airworthiness remove moisture, but may not be Certification Service, 1601 Lind Avenue regulations do not contain adequate or adequate to maintain a sufficiently clear SW., Renton, Washington, 98057–3356; appropriate safety standards for this area of the windshield in low speed telephone 425–227–1209; facsimile design feature. These proposed special flight or during surface operations. 425–227–1320. conditions contain the additional safety Alternatively, airflow over the standards that the Administrator SUPPLEMENTARY INFORMATION: windshield may be disturbed during considers necessary to establish a level Comments Invited critical times such as the approach to of safety equivalent to that established land, where the airplane is at higher- by the existing airworthiness standards. We invite interested people to take than-normal pitch angle. DATES: Send your comments on or part in this rulemaking by sending before December 24, 2012. written comments, data, or views. The Type Certification Basis ADDRESSES: Send comments identified most helpful comments reference a Under the provisions of 14 CFR 21.17, by docket number [FAA–2012–1200] specific portion of the special Embraer S.A. must show that the Model using any of the following methods: conditions, explain the reason for any EMB–550 airplane meets the applicable • Federal eRegulations Portal: Go to recommended change, and include provisions of part 25, as amended by http://www.regulations.gov/ and follow supporting data. Amendments 25–1 through 25–127 the online instructions for sending your We will consider all comments we thereto. comments electronically. receive on or before the closing date for If the Administrator finds that the • Mail: Send comments to Docket comments. We may change these special applicable airworthiness regulations Operations, M–30, U.S. Department of conditions based on the comments we (i.e., 14 CFR part 25) do not contain Transportation (DOT), 1200 New Jersey receive. adequate or appropriate safety standards Avenue SE., Room W12–140, West Background for the Model EMB–550 airplane Building Ground Floor, Washington, because of a novel or unusual design DC, 20590–0001. On May 14, 2009, Embraer S.A. feature, special conditions are • Hand Delivery or Courier: Take applied for a type certificate for their prescribed under the provisions of comments to Docket Operations in new Model EMB–550 airplane. The § 21.16. Room W12–140 of the West Building Model EMB–550 airplane is the first of Special conditions are initially Ground Floor at 1200 New Jersey a new family of jet airplanes designed applicable to the model for which they Avenue SE, Washington, DC, between 8 for corporate flight, fractional, charter, are issued. Should the type certificate a.m. and 5 p.m., Monday through and private owner operations. The for that model be amended later to Friday, except federal holidays. aircraft has a conventional configuration include any other model that • Fax: Fax comments to Docket with low wing and T-tail empennage. incorporates the same or similar novel Operations at 202–493–2251. The primary structure is metal with or unusual design feature, the special

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conditions would also apply to the other Accordingly, introduction of this Conclusion model under § 21.101. technology did not present a need for This action affects only certain novel In addition to the applicable special conditions to maintain the level or unusual design features on one model airworthiness regulations and special of safety embodied in the existing of airplanes. It is not a rule of general conditions, the Embraer S.A. Model regulations. applicability. EMB–550 airplane must comply with Hydrophobic windshield coatings the fuel vent and exhaust emission List of Subjects in 14 CFR Part 25 may depend to some degree on airflow requirements of 14 CFR part 34 and the directly over the windshield to maintain Aircraft, Aviation safety, Reporting noise certification requirements of 14 and recordkeeping requirements. CFR part 36 and the FAA must issue a a clear vision area. The heavy rain and high-speed conditions specified in the The authority citation for these finding of regulatory adequacy under special conditions is as follows: § 611 of Public Law 92–574, the ‘‘Noise current rule do not necessarily represent Control Act of 1972.’’ the limiting conditions for this new Authority: 49 U.S.C. 106(g), 40113, 44701, The FAA issues special conditions, as technology. For example, airflow over 44702, 44704. the windshield, which may be necessary defined in 14 CFR 11.19, in accordance The Proposed Special Conditions with § 11.38, and they become part of to remove moisture from the the type-certification basis under windshield, may not be adequate to Accordingly, the Federal Aviation § 21.17(a)(2). maintain a sufficiently clear area of the Administration (FAA) proposes the windshield in low speed flight or during following special conditions as part of Novel or Unusual Design Features ground operations. Alternatively, the type certification basis for Embraer The Embraer S.A. Model EMB–550 airflow over the windshield may be S.A. Model EMB–550 airplanes. airplane will incorporate the following disturbed during such critical times as Hydrophobic Coatings in Lieu of novel or unusual design features: The the approach to land, where the airplane Windshield Wipers Model EMB–550 airplane has a is at a higher than normal pitch attitude. hydrophobic coating on the windshield In these cases, areas of airflow The airplane must have a means to to provide adequate pilot compartment disturbance or separation on the maintain a clear portion of the view in precipitation in lieu of windshield could cause failure to windshield, during precipitation windshield wipers. maintain a clear vision area on the conditions, enough for both pilots to windshield. have a sufficiently extensive view along Discussion the ground or flight path in normal taxi 14 CFR 25.773(b)(1) requires a means In addition to potentially depending and flight attitudes of the airplane. This to maintain a clear portion of the on airflow to function effectively, means must be designed to function, windshield for both pilots to have a hydrophobic coatings may also be without continuous attention on the sufficiently extensive view along the dependent on water droplet size for part of the flightcrew, in conditions flight path during precipitation effective precipitation removal. For from light misting precipitation to heavy conditions. The regulations require this example, precipitation in the form of a rain at speeds from fully stopped in still light mist may not be sufficient for the means to maintain such an area during air, to 1.5 VSR1 with lift and drag devices precipitation in heavy rain at speeds up coating’s properties to result in retracted. maintaining a clear area of vision. to 1.5 VSR1. The requirement that the Issued in Renton, Washington, on means to maintain a clear area of In summary, the current regulations November, 5, 2012. forward vision must function at high identify speed and precipitation rate Ali Bahrami, speeds and high precipitation rates is requirements that represent limiting Manager, Transport Airplane Directorate, based on the use of windshield wipers conditions for windshield wipers and Aircraft Certification Service. as the means to maintain an adequate blowers, but not for hydrophobic [FR Doc. 2012–27373 Filed 11–8–12; 8:45 am] area of clear vision in precipitation coatings, so it is necessary to issue BILLING CODE 4910–13–P conditions. The requirement in 14 CFR special conditions to maintain the level 121.313(b), and in 14 CFR 125.213(b), to of safety represented by the current provide ‘‘a windshield wiper or regulations. DEPARTMENT OF TRANSPORTATION equivalent for each pilot station’’ has These special conditions provide an remained unchanged since at least 1953. appropriate safety standard for the Federal Aviation Administration The effectiveness of windshield hydrophobic coating technology as the wipers to maintain an area of clear means to maintain a clear area of vision 14 CFR Part 25 vision normally degrades as airspeed by requiring it to be effective at low and precipitation rates increase. It is [Docket No. FAA–2012–1199; Notice No. 25– speeds and precipitation rates as well as assumed that because high speeds and 12–06–SC] the higher speeds and precipitation high precipitation rates represent rates identified in the current Special Conditions: Embraer S.A., limiting conditions for windshield regulation. Model EMB–550 Airplanes; Flight wipers, they will also be effective at Envelope Protection: Performance lower speeds and precipitation levels. Applicability Credit for Automatic Takeoff Thrust Accordingly, § 25.773(b)(1)(i) does not Control System (ATTCS) During Go- As discussed above, these special require maintenance of a clear area of Around forward vision at lower speeds or lower conditions are applicable to the Embraer precipitation rates. S.A. Model EMB–550 airplane. Should AGENCY: Federal Aviation A forced airflow blown directly over Embraer S.A. apply at a later date for a Administration (FAA), DOT. the windshield has also been used to change to the type certificate to include ACTION: Notice of proposed special maintain an area of clear vision in another model incorporating the same conditions. precipitation. The limiting conditions novel or unusual design feature, the for this technology are comparable to special conditions would apply to that SUMMARY: This action proposes special those for windshield wipers. model as well. conditions for the Embraer S.A. Model

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EMB–550 airplane. This airplane will Transport Airplane Directorate, Aircraft Type Certification Basis have a novel or unusual design Certification Service, 1601 Lind Avenue Under the provisions of Title 14, Code feature(s) associated with the use of an SW., Renton, Washington, 98057–3356; of Federal Regulations (14 CFR) 21.17, Automatic Takeoff Thrust Control telephone 425–227–2011; facsimile Embraer S.A. must show that the Model System (ATTCS) during go-around. The 425–227–1149. EMB–550 airplane meets the applicable applicable airworthiness regulations do SUPPLEMENTARY INFORMATION: provisions of part 25, as amended by not contain adequate or appropriate Comments Invited Amendments 25–1 through 25–127 safety standards for this design feature. thereto. These proposed special conditions We invite interested people to take If the Administrator finds that the contain the additional safety standards part in this rulemaking by sending applicable airworthiness regulations that the Administrator considers written comments, data, or views. The (i.e., 14 CFR part 25) do not contain necessary to establish a level of safety most helpful comments reference a adequate or appropriate safety standards equivalent to that established by the specific portion of the special for the Model EMB–550 airplane existing airworthiness standards. conditions, explain the reason for any because of a novel or unusual design DATES: Send your comments on or recommended change, and include feature, special conditions are before December 24, 2012. supporting data. prescribed under the provisions of ADDRESSES: Send comments identified We will consider all comments we § 21.16. by docket number FAA–2012–1199 receive on or before the closing date for Special conditions are initially using any of the following methods: comments. We may change these special applicable to the model for which they • Federal eRegulations Portal: Go to conditions based on the comments we are issued. Should the type certificate http://www.regulations.gov/ and follow receive. for that model be amended later to the online instructions for sending your Background include any other model that comments electronically. incorporates the same or similar novel • Mail: Send comments to Docket On May 14, 2009, Embraer S.A. or unusual design feature, the special Operations, M–30, U.S. Department of applied for a type certificate for their conditions would also apply to the other Transportation (DOT), 1200 New Jersey new Model EMB–550 airplane. The model under § 21.101. Avenue SE., Room W12–140, West Model EMB–550 airplane is the first of In addition to the applicable Building Ground Floor, Washington, DC a new family of jet airplanes designed airworthiness regulations and special 20590–0001. for corporate flight, fractional, charter, conditions, the Model EMB–550 • Hand Delivery or Courier: Take and private owner operations. The airplane must comply with the fuel vent comments to Docket Operations in aircraft has a conventional configuration and exhaust emission requirements of Room W12–140 of the West Building with low wing and T-tail empennage. 14 CFR part 34 and the noise Ground Floor at 1200 New Jersey The primary structure is metal with certification requirements of 14 CFR Avenue SE., Washington, DC, between 8 composite empennage and control part 36 and the FAA must issue a a.m. and 5 p.m., Monday through surfaces. The Model EMB–550 airplane finding of regulatory adequacy under Friday, except federal holidays. is designed for 8 passengers, with a § 611 of Public Law 92–574, the ‘‘Noise • Fax: Fax comments to Docket maximum of 12 passengers. It is Control Act of 1972.’’ Operations at 202–493–2251. equipped with two Honeywell The FAA issues special conditions, as Privacy: The FAA will post all HTF7500–E medium bypass ratio defined in 14 CFR 11.19, in accordance comments it receives, without change, turbofan engines mounted on aft with § 11.38, and they become part of to http://www.regulations.gov/, fuselage pylons. Each engine produces the type-certification basis under including any personal information the approximately 6,540 pounds of thrust § 21.17(a)(2). commenter provides. Using the search for normal takeoff. The primary flight function of the docket web site, anyone controls consist of hydraulically Novel or Unusual Design Features can find and read the electronic form of powered fly-by-wire elevators, ailerons The Embraer S.A. Model EMB–550 all comments received into any FAA and rudder, controlled by the pilot or airplane has an ATTCS that is used for docket, including the name of the copilot sidestick. both takeoff and go-around functions. individual sending the comment (or Embraer S.A. has incorporated an Section 25.904 and part 25 appendix signing the comment for an association, ATTCS function into the engine of the I refer to operations of ATTCS only business, labor union, etc.). DOT’s Model EMB–550 airplane. It has a full during takeoff. The Embraer S.A. Model complete Privacy Act Statement can be authority digital electronic control EMB–550 airplane also provides for use found in the Federal Register published system architecture. Embraer S.A. of ATTCS for go-arounds. As a result, if on April 11, 2000 (65 FR 19477–19478), proposed allowing performance credit an engine failure occurs during a go- as well as at for this function during go-arounds to around, the remaining engine http://DocketsInfo.dot.gov/. show compliance with the requirements automatically applies maximum go- Docket: Background documents or of § 25.121(d) for approach climb around thrust. In addition, in the case comments received may be read at performance. Since the airworthiness of an approach with one engine already http://www.regulations.gov/ at any time. requirements do not contain appropriate inoperative, if it is necessary to perform Follow the online instructions for safety standards for approach climb a go-around, the operating engine accessing the docket or go to the Docket performance using ATTCS, special automatically applies maximum go- Operations in Room W12–140 of the conditions are required to establish a around thrust. West Building Ground Floor at 1200 level of safety equivalent to that of the These special conditions are intended New Jersey Avenue SE., Washington, regulations. to ensure that the ATTCS functions DC, between 9 a.m. and 5 p.m., Monday Part 25 appendix I contains standards correctly and meets expected through Friday, except federal holidays. for use of ATTCS during takeoff. These performance requirements during go- FOR FURTHER INFORMATION CONTACT: Joe special conditions establish standards to arounds when the airplane is limited by Jacobsen, FAA, Airplane and Flight extend the use of ATTCS to the go- weight, altitude, and/or temperature Crew Interface Branch, ANM–111, around phase. during an approach.

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Discussion special conditions would apply to that a. The critical time interval begins at model as well. a point on a 2.5 degree approach glide Since current airworthiness path from which, assuming a requirements do not contain safety Conclusion simultaneous engine and ATTCS standards to allow credit for ATTCS in This action affects only certain novel failure, the resulting approach climb determining approach climb or unusual design features on one model flight path intersects a flight path performance, these special conditions of airplanes. It is not a rule of general originating at a later point on the same are required to establish a level of safety applicability. approach path corresponding that equivalent to that of the regulations. The corresponds to the 14 CFR part 25 one- definition of a critical time interval for List of Subjects in 14 CFR Part 25 engine-inoperative approach climb the approach climb case similar to the Aircraft, Aviation safety, Reporting gradient. The period of time from the critical time interval for takeoff defined and recordkeeping requirements. point of simultaneous engine and in part 25 appendix I is of primary The authority citation for these ATTCS failure to the intersection of importance. During an approach climb, special conditions is as follows: these flight paths must be no shorter it must be extremely improbable to than the time interval used in evaluating violate a flight path based on the climb Authority: 49 U.S.C. 106(g), 40113, 44701, the critical time interval for takeoff gradient requirement of § 25.121(d). 44702, 44704. beginning from the point of This climb gradient requirement implies The Proposed Special Conditions simultaneous engine and ATTCS failure a minimum one-engine-inoperative Accordingly, the Federal Aviation and ending upon reaching a height of flight path capability with the airplane Administration (FAA) proposes the 400 feet. in the approach configuration. The following special conditions as part of b. The critical time interval ends at engine may have been inoperative the type certification basis for Embraer the point on a minimum performance, before initiating the go-around, or it may S.A. Model EMB–550 airplanes. all-engines-operating go-around flight become inoperative during the go- 1. The Model EMB–550 airplane must path from which, assuming a around. The definition of the critical comply with the requirements of 14 CFR simultaneous engine and ATTCS time interval must consider both 25.904 and appendix I to 14 CFR part failure, the resulting minimum possibilities. 25 and the following requirements approach climb flight path intersects a The propulsive thrust used to pertaining to the go-around phase of flight path corresponding to the 14 CFR determine compliance with the flight: part 25 minimum one-engine- approach climb requirements of 2. Definitions inoperative approach climb gradient. § 25.121(d) is limited to the lesser of: a. Takeoff/go-around (TOGA): throttle • The all-engines-operating go-around The thrust provided by the ATTCS, lever in takeoff or go-around position. flight path and the 14 CFR part 25 one- or b. Automatic takeoff thrust control engine-inoperative approach climb • 111% of the thrust resulting from system (ATTCS): the ATTCS in Model gradient flight path originate from a the initial thrust setting with the ATTCS EMB–550 airplanes is defined as the common point on a 2.5 degree approach failing to perform its uptrim function entire automatic system available during path. The period of time from the point and without action by the flightcrew to takeoff and in go-around mode, of simultaneous engine and ATTCS reset thrust. including all devices, both mechanical failure to the intersection of these flight This requirement serves to limit the and electrical, that sense engine failure, paths must be no shorter than the time adverse performance effects of a transmit signals, actuate fuel controls or interval used in evaluating the critical combined engine and ATTCS failure, power levers (or increase engine power time interval for the takeoff beginning and ensures adequate performance of an by other means on operating engines to from the point of simultaneous engine all-engines-operating go-around. achieve scheduled thrust or power and ATTCS failure and ending upon increase), and furnish cockpit reaching a height of 400 feet. Applicability information on system operation. ii. The critical time interval must be As discussed above, these special c. Critical time interval: the definition determined at the altitude resulting in conditions are applicable to the Embraer of the critical time interval in 14 CFR the longest critical time interval for S.A. Model EMB–550 airplane. Should appendix I 25.2(b) must be expanded to which one-engine-inoperative approach Embraer S.A. apply at a later date for a include the following: climb performance data are presented in change to the type certificate to include i. When conducting an approach for the airplane flight manual (AFM). another model incorporating the same landing using ATTCS, the critical time iii. The critical time interval is novel or unusual design feature, the interval is defined as follows: illustrated in the following figure:

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3. Performance and system reliability power or thrust controls with the airplane under the existing conditions requirements: The applicant must ATTCS failing to reset thrust or power through the use of the power lever. For comply with the performance and and without any action by the airplanes equipped with limiters that ATTCS reliability requirements as flightcrew to reset thrust or power. automatically prevent the engine follows: 4. Thrust setting operating limits from being exceeded a. An ATTCS failure or a combination a. The initial go-around thrust setting under existing ambient conditions, of failures in the ATTCS during the on each engine at the beginning of the other means may be used to increase the critical time interval: go-around phase may not be less than thrust in the event of an ATTCS failure, i. Must not prevent the insertion of any of the following: provided that the means: the maximum approved go-around i. That required to permit normal 1. Is located on or forward of the thrust or power, or must be shown to be operation of all safety-related systems power levers; a remote event. and equipment dependent upon engine 2. Is easily identified and operated ii. Must not result in a significant loss thrust or power lever position; or under all operating conditions by a or reduction in thrust or power, or must ii. That shown to be free of hazardous single action of either pilot with the be shown to be an extremely improbable engine response characteristics and not hand that is normally used to actuate event. to result in any unsafe aircraft operating the power levers; and b. The concurrent existence of an or handling characteristics when thrust 3. Meets the requirements of ATTCS failure and an engine failure or power is advanced from the initial § 25.777(a), (b), and (c). during the critical time interval must be go-around position to the maximum iii. Provide a means to verify to the shown to be extremely improbable. approved power setting. flightcrew before beginning an approach c. All applicable performance b. For approval to use an ATTCS for for landing that the ATTCS is in a requirements of 14 CFR part 25 must be go-arounds, the thrust setting procedure condition to operate (unless it can be met with an engine failure occurring at must be the same for go-arounds demonstrated that an ATTCS failure the most critical point during go-around initiated with all engines operating as combined with an engine failure during with the ATTCS functioning. for go-around initiated with one engine an entire flight is extremely d. The probability analysis must inoperative. include consideration of ATTCS failure 5. Powerplant controls improbable); and occurring after the time at which the a. In addition to the requirements of iv. Provide a means for the flightcrew flightcrew last verifies that the ATTCS § 25.1141, no single failure or to deactivate the automatic function. is in a condition to operate until the malfunction, or probable combination This means must be designed to prevent beginning of the critical time interval. thereof, of the ATTCS, including inadvertent deactivation. e. The propulsive thrust obtained associated systems, may cause the 6. Powerplant instruments: In from the operating engine after failure of failure of any powerplant function addition to the requirements of the critical engine during a go-around necessary for safety. § 25.1305: used to show compliance with the one- b. The ATTCS must be designed to: a. A means must be provided to engine-inoperative climb requirements i. Apply thrust or power on the indicate when the ATTCS is in the of § 25.121(d) may not be greater than operating engine(s), following any one- armed or ready condition; and the lesser of: engine failure during a go-around, to b. If the inherent flight characteristics i. The actual propulsive thrust achieve the maximum approved go- of the airplane do not provide adequate resulting from the initial setting of around thrust without exceeding the warning that an engine has failed, a power or thrust controls with the engine operating limits; warning system that is independent of ATTCS functioning; or ii. Permit manual decrease or increase the ATTCS must be provided to give the ii. 111% of the propulsive thrust in thrust or power up to the maximum pilot a clear warning of any engine resulting from the initial setting of go-around thrust approved for the failure during a go-around.

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Issued in Renton, Washington, on copies of these documents. Instead of document: Electronic copies of these November 5, 2012. transmitting facsimile copies of documents are available at OSHA’s Web Ali Bahrami, attachments that supplement these page at http://www.osha.gov. Manager, Transport Airplane Directorate, documents (e.g., studies, journal SUPPLEMENTARY INFORMATION: Aircraft Certification Service. articles), commenters must submit these Table of Contents [FR Doc. 2012–27372 Filed 11–8–12; 8:45 am] attachments to the OSHA Docket Office, BILLING CODE 4910–13–P Technical Data Center, Room N–2625, I. Request for Comment OSHA, U.S. Department of Labor, 200 II. Direct Final Rulemaking Constitution Ave., NW., Washington, III. Discussion of the Digger-Derrick Exemption in 29 CFR 1926, Subpart CC DEPARTMENT OF LABOR DC 20210. These attachments must clearly identify the sender’s name, the A. Background B. Changes to the Text of the Exemption in Occupational Safety and Health date, and the docket number (OSHA– 29 CFR 1926.1400(c)(4) Administration 2012–0025), so that the Docket Office C. Discussion of Conforming Revisions to can attach them to the appropriate 29 CFR 1926, Subpart V (Power 29 CFR Part 1926 document. Transmission and Distribution) IV. Agency Determinations [Docket ID–OSHA–2012–0025] Regular or express mail, hand delivery, or messenger (courier) service: A. Significant Risk RIN 1218–AC75 Submit comments and any additional B. Final Economic Analysis and Final information or material to the OSHA Regulatory Flexibility Analysis Revising the Exemption for Digger C. Technological Feasibility Docket Office, Docket No. OSHA–2012– D. Paperwork Reduction Act of 1995 Derricks in the Cranes and Derricks in 0025 or RIN No. 1218–AC75, Technical Construction Standard E. Federalism Data Center, Room N–2625, OSHA, U.S. F. State Plan States AGENCY: Occupational Safety and Health Department of Labor, 200 Constitution G. Unfunded Mandates Reform Act Administration (OSHA); Labor. Ave., NW., Washington, DC 20210; H. Consultation and Coordination With Indian Tribal Governments ACTION: Notice of proposed rulemaking. telephone: (202) 693–2350. (OSHA’s TTY number is (877) 889–5627.) Contact List of Subjects in 29 CFR Part 1926 SUMMARY: OSHA is broadening the the OSHA Docket Office for information Authority and Signature exemption for digger derricks in its about security procedures concerning Amendments to Standards standard for cranes and derricks. OSHA delivery of materials by express mail, I. Request for Comment issued a final standard updating the hand delivery, and messenger service. OSHA requests comments on all requirements for cranes and derricks on The Docket Office will accept deliveries issues related to this proposed rule, August 9, 2010, and the Edison Electric (express mail, hand delivery, and including economic, paperwork, or Institute (EEI) petitioned for review of messenger service) during the Docket other regulatory impacts of this rule on the standard in the United States Court Office’s normal business hours, 8:15 the regulated community. If OSHA of Appeals. After petitioning, EEI a.m. to 4:45 p.m. ET. receives no significant adverse comment provided OSHA with new information Docket: To read or download to either this proposal or the direct final regarding digger derricks. OSHA comments or other information or rule, OSHA will publish a Federal reviewed the additional information and material in the docket, go to http:// Register document confirming the the rulemaking record, and decided to www.regulations.gov or to the OSHA effective date of the direct final rule and broaden the exemption for digger Docket Office at the address above. withdrawing this companion proposed derricks used in the electric-utility Documents in the docket are listed in rule published in the ‘‘Proposed Rules’’ industry by means of this proposed rule. the http://www.regulations.gov index; section of today’s Federal Register. DATES: Comment by December 10, 2012. however, some information (e.g., Such confirmation may include minor All submissions, whether transmitted, copyrighted material) is not available stylistic or technical changes to the mailed, or delivered, must bear a publicly to read or download through document. For the purpose of judicial postmark or provide other evidence of this Web site. All submissions, review, OSHA views the date of the submission date. including copyrighted material, are confirmation of the effective date of this ADDRESSES: Submit comments available for inspection at the OSHA direct final rule as the date of (including comments to the Docket Office. Contact the OSHA Docket promulgation. information-collection (paperwork) Office for assistance in locating docket determination described under the submissions. II. Direct Final Rulemaking section titled AGENCY FOR FURTHER INFORMATION CONTACT: In direct final rulemaking, an agency DETERMINATIONS), hearing requests, General information and press inquiries: publishes a direct final rule in the and other information and materials, Mr. Frank Meilinger, Director, OSHA Federal Register with a statement that identified by Docket No. OSHA–2012– Office of Communications, Room N– the rule will go into effect unless the 0025, by any of the following methods: 3647, U.S. Department of Labor, 200 agency receives significant adverse Electronically: Submit comments and Constitution Avenue NW., Washington, comment within a specified period. The attachments electronically at http:// DC 20210; telephone: (202) 693–1999; agency may publish an identical www.regulations.gov, which is the email: [email protected]. proposed rule at the same time. If the Federal eRulemaking Portal. Follow the Technical inquiries: Mr. Garvin agency receives no significant adverse instructions online for submitting Branch, Directorate of Construction, comment in response to the direct final comments. Room N–3468, OSHA, U.S. Department rule, the rule goes into effect. OSHA Facsimile: OSHA allows facsimile of Labor, 200 Constitution Avenue NW., typically confirms the effective date of transmission of comments that are 10 Washington, DC 20210; telephone: (202) a direct final rule through a separate pages or fewer in length (including 693–2020; fax: (202) 693–1689; email: Federal Register notice. If the agency attachments). Fax these documents to [email protected]. receives a significant adverse comment, the OSHA Docket Office at (202) 693– For copies of this Federal Register the agency withdraws the direct final 1648; OSHA does not require hard notice, news releases, and other relevant rule and treats such comment as a

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response to the proposed rule. An decide whether to publish a new final Commenters complained that the agency typically uses direct final rule. exemption would be largely rulemaking when an agency anticipates OSHA determined that the subject of meaningless unless it also encompassed that a rule will not be controversial. this rulemaking is suitable for direct these functions. Several representatives For purposes of this proposed rule final rulemaking. OSHA originally of the telecommunications industry and the companion direct final rule, a included the digger-derrick exemption noted that the industry used digger significant adverse comment is one that in the proposed Cranes and Derricks in derricks routinely for similar purposes, explains why the amendments to Construction standard as a result of and requested that OSHA expand the OSHA’s digger-derrick exemption negotiated rulemaking involving digger-derrick exemption to encompass would be inappropriate. In determining stakeholders from many affected sectors. telecommunications work in addition to whether a comment necessitates The existing rule for Cranes and electric-utility work (Docket ID OSHA– withdrawal of the direct final rule, Derricks in Construction, subpart CC of 2007–0066–0234 and OSHA–2007– OSHA will consider whether the 29 CFR part 1926, exempts the majority 0066–0129.1). comment raises an issue serious enough of digger derricks used in the When OSHA issued the final Cranes to warrant a substantive response in a telecommunications and electric-utility and Derricks in Construction rule, it notice-and-comment process. OSHA industries from the requirements of that noted concerns about the scope of the will not consider a comment subpart. Because the revision specified exemption, and broadened the scope of recommending an additional in this proposed rule extends the the exemption (see 75 FR 47906, 47924– amendment to be a significant adverse exemption to a small number of digger 47926, and 48136 (Aug. 9, 2010)). comment unless the comment states derricks used in the electric-utility Current subpart CC, therefore, exempts why the direct final rule would be industry, and does not impose any new digger derricks used by both the ineffective without the addition. costs or duties, OSHA does not expect electric-utility and the Furthermore, OSHA will not consider a objections from the public to this telecommunications industries, and comment requesting any narrowing of rulemaking action. encompasses all pole work in these the existing digger-derrick exemption to industries, including placing utility III. Discussion of the Digger-Derrick poles in the ground and attaching be a significant adverse comment Exemption in 29 CFR 1926, Subpart CC because narrowing the existing transformers and other equipment to the exemption is beyond the scope of this A. Background of the Digger-Derrick poles (see 29 CFR 1400(c)(4)). In that rulemaking. Moreover, a comment Exemption exemption, OSHA clarifies that digger derricks in construction that are exempt requesting an expansion of the A ‘‘digger derrick’’ or ‘‘radial boom from subpart CC must still comply with exemption to encompass activities not derrick’’ is a specialized type of the applicable worker protections in the related to digger-derrick use by electric equipment designed to install utility OSHA standards governing electric- utilities also would be beyond the scope poles. A digger derrick typically is utility and telecommunications work at of this rulemaking, and OSHA will not equipped with augers to drill holes for §§ 1910.268 and 1910.269. The existing consider such a comment to be a the poles and with a hydraulic boom to exemption in § 1926.1400(c) states that significant adverse comment unless the lift the poles and set them in the holes. the subpart does not cover digger commenter explains why the provisions Employers also use the booms to lift derricks when used for augering holes of the direct final rule, as these objects other than poles; accordingly, for poles carrying electric and provisions apply to digger derricks, electric utilities, telecommunication telecommunication lines, placing and would be ineffective without the companies, and their contractors use removing the poles, and for handling expansion. booms both to place objects on utility associated materials to be installed on or In addition to publishing this poles and for general lifting purposes at removed from the poles. Digger derricks proposed rule, OSHA is publishing a worksites (Docket ID OSHA–2007– used in work subject to 29 CFR part companion direct final rule in the 0066–0139.1). When OSHA 1926, subpart V, must comply with 29 ‘‘Final Rules’’ section of today’s Federal promulgated subpart V (Power CFR 1910.269. Digger derricks used in Register. The comment period for this Transmission and Distribution) in 1972, construction work for proposed rule runs concurrently with it excluded digger derricks from certain telecommunication service (as defined that of the direct final rule. OSHA also requirements of 29 CFR 1926, subpart N, at 29 CFR 1910.268(s)(40)) must comply will treat comments received on the the predecessor to the current 29 CFR companion direct final rule as with 29 CFR 1910.268. 1926, subpart CC, standard. When the activities are exempt from comments regarding the proposed rule. OSHA developed the proposed subpart CC of 29 CFR part 1926, they Likewise, OSHA will consider standard for cranes and derricks in must still comply with all other significant adverse comment submitted construction through a negotiated applicable construction standards, such to the proposed rule as comment to the rulemaking involving stakeholders from as 29 CFR part 1926, subpart O (Motor direct final rule. Therefore, if OSHA many affected sectors. The proposed Vehicles, Mechanized Equipment, and receives a significant adverse comment standard included a limited exemption Marine Operations), and subpart V.1 on either the direct final rule or this for digger derricks (73 FR 59714, 59916 (Oct. 9, 2008)). After the publication of proposed rule, it will publish a timely 1 For telecommunications work, compliance with withdrawal of the direct final rule and the proposed rule, OSHA received many the provisions of § 1910.268 is a condition of the proceed with this proposed rule. In the comments criticizing the scope of the exemption in § 1926.400(c)(4). The scope event that OSHA withdraws the direct exemption because the scope applied to limitations in § 1910.268(a) (such as the language digger derricks designed for the electric- stating that it does not apply to construction) are final rule because of significant adverse irrelevant to application of the exemption. If an comment, OSHA will consider all utility industry, and then only when employer uses a digger derrick for timely comments received in response used to dig holes for utility work. telecommunications construction work and does to the direct final rule when it continues Commenters noted that customary use not comply with the provisions in § 1910.268, then of the digger derrick also involved that employer fails to qualify for the exemption in with this proposed rule. After carefully § 1926.400(c)(4). As a result, that employer must considering all comments to the direct placing a pole in the hole and attaching comply with all of the requirements in subpart CC final rule and the proposal, OSHA will transformers and other items to the pole. of part 1926, including the operator-certification

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On October 6, 2010, Edison Electrical way along front property lines, close to the burdens on employers for the Institute petitioned for review of the a roadway, or along rear property lines, remaining five percent of non-exempted Cranes and Derricks in Construction irrespective of whether the transformers work, and revising the digger-derrick standard in the U.S. Court of Appeals are pole- or pad-mounted. In those exemption to include all digger derricks for the District of Columbia. During cases, the lifting radius of a digger used in construction work subject to 29 subsequent discussions with OSHA, EEI derrick placing a transformer on a pad CFR part 1926, subpart V. Based on its provided new information to OSHA is similar to the lifting radius of a digger estimates in the Final Economic regarding the use of digger derricks in derrick placing a transformer on a pole. Analysis in the 2010 final rule, the the electric-utility industry and the Consequently, the lifting forces on a Agency determined that expanding the resulting impact on the utilities’ digger derrick should be approximately exemption for digger derricks will operations under the current digger- the same regardless of whether the enable employers in NAICS 221120 to derrick exemption in subpart CC. transformer is pole- or pad-mounted avoid compliance costs of about $15.9 According to EEI, the exemption from (see, e.g., OSHA–2012–0025–0003). million per year, while employers in subpart CC covers roughly 95 percent of Finally, the approximate height of the NAICS 221110 will avoid about $5.7 work conducted by digger derricks in transformer relative to the employee million per year, for a total cost savings the electric-utility industry (see OSHA– installing the transformer is the same for of about $21.6 million annually. 2012–0025–0004 for EEI Dec. 7, 2010, the two types of transformers. An When the Agency promulgated the letter, page 2). The majority of the work employee installing a pad-mounted final Cranes and Derricks in under the remaining five percent is transformer is on the ground, near the Construction rule, OSHA’s primary work that is closely related to the pad, whereas an employee installing a concern about extending the digger- exempted work. Id. For example, when pole-mounted transformer is either on derrick exemption beyond pole work electric utilities use digger derricks to the pole, or in an aerial lift, near the was that such an extension would perform construction work involving mounting point for the transformer. In provide employers with an incentive to pole installations, the same digger- either case, the transformer would be use digger derricks on construction sites derrick crew that performs the pole around the same height as the to perform construction tasks normally work typically installs pad-mount employee. handled by cranes—tasks that are Because the same workers generally transformers on the ground as part of beyond the original design capabilities perform both types of work, utility the same power system as the poles. of a digger derrick. In discussing this While the pole work is exempt under 29 employers must, when the standard becomes fully effective in November concern, OSHA stated, ‘‘[T]he general CFR 1926.1400(c)(4), the placement of lifting work done at those other the pad-mount transformer on the 2014, incur the cost of meeting all other requirements in subpart CC, including worksites would be subject to this ground is not. standard if done by other types of lifting Furthermore, in comparison to the operator-certification requirements, for those workers to perform the five equipment, and the same standards currently exempted pole work, OSHA should apply as apply to that equipment believes most (if not all) of the percent of the work not currently exempted. The result could be a sizable . . . .’’ (75 FR 47925). OSHA remaining five percent of work is at acknowledges that revising the least as safe. Weight measurements cost (about $21.6 million annually) for an activity that does not appear exemption would extend the digger- provided by EEI demonstrate that derrick exemption to include some work transformers placed on a pad on the significantly more dangerous than the type of activity that OSHA already at substations. However, EEI indicated ground are roughly the same weight as, exempted. (See Section IV.B. (Final that the employers in the electric-utility or in some cases lighter than, the weight Economic Analysis and Final industry limit such uses to assembly or of the transformers lifted onto the poles, Regulatory Flexibility Act Analysis) in arrangement of substation components, or the poles themselves (see OSHA– this preamble for a summary of these and that these employers use other 2012–0025–0003 for EEI handout, costs.) OSHA did not consider this types of cranes instead of digger ‘‘Typical Weights’’ chart).2 In addition, result when it promulgated the derricks to perform lifting and electric utilities typically place standard. installation work at substations (see distribution transformers in a right of OSHA acknowledges the arguments OSHA–2012–0025–0005 for Jan. 2011 that there are minimal safety benefits EEI letter). If OSHA finds that, should requirements in § 1926.1427. If the employer fails the direct final rule become a final rule, to comply with subpart CC, and cannot demonstrate attributable to imposing the standard’s that it complied with § 1910.268 for requirements on the remaining five employers are using digger derricks telecommunications work, or § 1910.269 for percent of non-exempted work; increasingly for other tasks, the Agency electric-utility work, then OSHA will cite the moreover, the exempted digger-derrick may revisit this issue and adjust the employer under subpart CC (not § 1910.268 or exemption accordingly. The Agency § 1910.269). If the employer demonstrates that it operations are still subject to the complies with the exemption in subpart CC, but protections afforded to workers by also recognizes that, because the does not comply with the separate requirements in OSHA’s electric-utility and exemption only applies to work subject subpart O applicable to all motorized vehicles in telecommunications standards to the electrical-power and construction, then OSHA will cite the employer (§ 1910.269, subpart V of 29 CFR part telecommunications standards, under subpart O. Note that this explanation does not suggest that OSHA is restricting its enforcement 1926, and § 1910.268, respectively). employers cannot use digger derricks discretion on whether to issue citations at all. OSHA also notes that the largest labor within this exemption to perform 2 EEI’s chart does not show weights for concrete organization for workers in the electric- unrelated tasks such as the construction and plastic transformer pads, and EEI did not utility industry, the International of a building or the foundation or indicate that utilities use digger derricks to place those pads. If utilities do use digger derricks to lift Brotherhood of Electrical Workers, structural components of a substation pads, EEI’s presentation indicates that the digger participated in settlement discussions, before the installation of electric power- derricks lift the transformers separately. Because corroborated the general validity of the transmission or power-distribution the surface area of these pads is comparable to the information provided by EEI, and equipment. A digger derrick used for transformers on them, and because these pads are generally only a few hundred millimeters thick, actively supported EEI’s request for an this type of construction will still be OSHA does not believe that the pads weigh any expanded digger-derrick exemption. In subject to the requirements in 29 CFR more than transformers or poles. light of these factors, OSHA is removing 1926, subpart CC, and operators will

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have to be certified in accordance with comply with § 1910.269. Thus, although regardless of whether employers use § 1926.1427. the revised exemption in this proposed them for work covered by subpart V or rule specifies compliance with subpart work covered by § 1910.269, and B. Changes to the Text of the Exemption V instead of § 1910.269, there is no regardless of whether employers use in 29 CFR 1926.1400(c)(4) substantive revision to digger derricks them for pole work or other subpart V OSHA is revising the exemption in 29 used for augering holes and handling work. CFR 1926.1400(c)(4) to include within associated materials. The primary the exemption ‘‘any other work subject purpose for this revision is to harmonize IV. Agency Determinations to subpart V of 29 CFR part 1926.’’ This the § 1926.1400(c)(4) exemption with 29 A. Significant Risk revision expands the exemption to CFR 1926.952(c)(2) to ensure that non- The purpose of the Occupational remove from coverage under subpart CC pole digger-derrick work covered by Safety and Health Act of 1970 (OSH Act; of 29 CFR part 1926 the types of non- subpart V receives the same protections 29 U.S.C. 651 et al.) is ‘‘to assure so far pole, digger-derrick work described by as pole work covered by subpart V. EEI. OSHA is not expanding the as possible every working man and exemption for pole work performed by C. Discussion of Conforming Revisions woman in the Nation safe and healthful employers in the telecommunications to 29 CFR Part 1926, Subpart V working conditions and to preserve our industry because no party raised or As part of this harmonizing process, human resources’’ (29 U.S.C. 651(b)). To requested such an exemption in the OSHA also is revising the corresponding achieve this goal, Congress authorized litigation; therefore, this issue is outside provision in subpart V that requires the Secretary of Labor to promulgate the scope of this rulemaking. compliance with § 1910.269 for all and enforce occupational safety and The Agency also is making several digger-derrick work exempted from health standards (29 U.S.C. 654(b), minor clarifications to the text of the subpart CC, including §§ 1910.269(p) 655(b)). An occupational safety or exemption. First, OSHA is making a (Mechanical equipment), 1910.269(a)(2) health standard is a standard that minor grammatical clarification by (Training), and 1910.269(l) (Working on ‘‘requires conditions, or the adoption or replacing ‘‘and’’ with ‘‘or’’ in the phrase or near exposed energized parts) (see use of one or more practices, means, ‘‘poles carrying electric or new 29 CFR 1926.952(c)(2)). When methods, operations, or processes, telecommunication lines’’ (emphasis OSHA promulgated subpart CC of 29 reasonably necessary or appropriate to added). This revision will ensure that CFR part 1926 in 2010, the Agency also provide safe or healthful employment the regulated community does not revised § 1926.952(c)(2) in subpart V of and places of employment’’ (29 U.S.C. misconstrue the exemption as limited to its construction standards (75 FR 652(8)). A standard is reasonably poles that carry both electric and 48135). The revision mirrored the necessary or appropriate within the telecommunications lines. This terminology in the digger-derrick meaning of Section 652(8) if it clarification is consistent with OSHA’s exemption in § 1926.1400(c)(4), and substantially reduces or eliminates explanation in the preamble of the required employers using digger significant risk (see Industrial Union Cranes and Derricks in Construction derricks so exempted to comply with Department, AFL–CIO v. American final rule (see 75 FR 47925). § 1910.269 (Electric power generation, Petroleum Institute, 448 U.S. 607 Second, OSHA is adding the phrase transmission, and distribution). In (1980)). ‘‘to be eligible for this exclusion’’ at the making this revision, the Agency noted This proposed rule does not impose beginning of the sentence requiring that it added specific minimum any additional requirements on compliance with § 1910.268 and subpart clearance-distance requirements, which employers. Because OSHA previously V of 29 CFR part 1926, respectively. are applicable to subpart V work, to the determined that the Cranes and Derricks This revision limits the exemption to cranes and derricks in construction in Construction standard substantially the use of digger derricks that comply rules at subpart CC, and explained that reduces a significant risk (see 75 FR with the requirements in subpart V or it revised § 1926.952(c) to require digger 47913), it is unnecessary for the Agency § 1910.268; if an employer uses a digger derricks to comply with § 1910.269 to to make additional findings on risk for derrick for subpart V or provide ‘‘comparable safety the purposes of this minor amendment telecommunications work without requirements’’ (75 FR 47921). to the digger-derrick exemption (see, complying with all of the requirements As revised, paragraph § 1926.952(c)(2) e.g., Public Citizen Health Research in subpart V or § 1910.268, then the requires employers using digger derricks Group v. Tyson, 796 F.2d 1479, 1502 work is not exempt, and the employer for subpart V work and, thus, not n.16 (D.C. Cir. 1986) (rejecting the must comply with all of the subject to the requirements of subpart argument that OSHA must ‘‘find that requirements of subpart CC of 29 CFR CC of 29 CFR part 1926, to comply with each and every aspect of its standard part 1926. This clarification is the requirements in § 1910.269. OHSA eliminates a significant risk’’). consistent with OSHA’s explanation of also is clarifying that paragraph (c)(2) the exemption in the preamble of the applies in addition to, not in place of, B. Final Economic Analysis and Final final rule (see 75 FR 47925–47926). the general requirement in § 1926.952(c) Regulatory Flexibility Act Analysis Third, OSHA is replacing the that all equipment (including digger When it issued the final rule for reference to § 1910.269 with a reference derricks) must comply with subpart O of Cranes and Derricks in Construction, to 29 CFR part 1926, subpart V. The 29 CFR part 1926. As noted in the OSHA prepared a Final Economic current exemption in § 1926.1400(c)(4) preamble to the subpart CC final rule, Analysis (FEA) as required by the requires employers using digger derricks OSHA currently is developing a rule Occupational Safety and Health Act of for work covered by subpart V to that will amend subpart V to avoid 1970 (‘‘OSH Act’’; 29 U.S.C. 651 et seq.) comply with the requirements in inconsistencies between subpart V of and Executive Orders 12866 and 13563. § 1910.269. However, in the 2010 final the construction standards and OSHA also published a final regulatory rule for Cranes and Derricks in § 1910.269 (see 70 FR 34822 (June 15, flexibility analysis as required by the Construction, OSHA also revised 29 2005)). Pending completion of that Regulatory Flexibility Act (5 U.S.C. CFR 1926.952(c)(2) of subpart V to rulemaking, digger derricks excluded 601–612). require digger derricks used for the from subpart CC of 29 CFR 1926 will be In the FEA for the final rule (OSHA– purposes exempted from subpart CC to subject to the same requirements 2007–0066–0422), the Agency estimated

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that there were about 10,000 crane per year in costs associated with digger on a substantial number of small operators in NAICS 221110 Electric derricks. These estimated cost savings entities. Power Generation, and about 20,000 may be slightly overstated because C. Technological Feasibility crane operators in NAICS 221120 OSHA noted in its FEA that the cost Electric Power Transmission, Control, assumptions might not represent the A standard is technologically feasible and Distribution. OSHA based these most efficient way to meet the when the protective measures it requires figures on estimates of the number of requirements of the rule. However, already exist, when available technology construction work crews in these OSHA wanted to assure the regulated can bring the protective measures into industries from its subpart V FEA, with community that, even with somewhat existence, or when that technology is an allowance (to assure maximum overstated cost estimates, the proposed reasonably likely to develop (see flexibility) that there be three trained rule would still be economically American Textile Mfrs. Institute v. crane operators for every work crew. feasible. OSHA, 452 U.S. 490, 513 (1981) (ATMI); Based on submissions to the record, In its original FEA (OSHA–2007– American Iron and Steel Institute v. OSHA estimated that 85 percent of these 0066–0422), OSHA reported an average OSHA, 939 F.2d 975, 980 (D.C. Cir. 30,000 operators (25,500) worked on of 0.5 crane-related fatalities per year in 1991) (AISI)). This proposed rule does digger derricks, while 15 percent of the SIC codes NAICS 221110 and NAICS not require any additional protective operators operated truck-mounted 221120. However, the original FEA did measures. In the original FEA, OSHA cranes, or boom trucks; therefore, a total not indicate that any of these fatalities found the standard to be technologically of 25,500 digger-derrick operators involved digger derricks or other feasible (75 FR 48079). OSHA concludes would require operator certification. equipment covered by the standard. that this revision is feasible as well In its FEA for the final rule, OSHA Moreover, in light of the information because it reduces or removes current requirements on employers. estimated that the total costs for NAICS provided by EEI, there is no indication 221110 would be $6.7 million ($4 that the additional five percent of D. Paperwork Reduction Act of 1995 million for operator certification), and digger-derrick activity exempted When OSHA issued the final rule on the total costs for NAICS 221120 would through this rulemaking poses any August 9, 2010, the Agency submitted be $18.7 million annually ($8.7 million hazard greater than the hazard posed by an Information Collection Request (ICR) for operator certification) (see FEA the digger-derrick activities OSHA to OMB titled Cranes and Derricks in Table B–9 in the Aug. 9, 2010, FR already exempted in the 2010 final rule. Construction (29 CFR Part 1926 Subpart notice). Fully exempting digger derricks Because this proposed rule estimates CC). On November 1, 2010, OMB from the scope of the standard also cost savings of $21.6 million per year, approved the ICR under OMB Control eliminates costs for other activities this proposed rule is not economically Number 1218–0261, with an expiration besides operator certification, such as significant within the meaning of date of November 30, 2013. inspections and power-line safety. In Executive Order 12866 (58 FR 51735). Subsequently, in December 2010, OSHA the original FEA, the two main cost The proposed rule does not impose discontinued the Cranes and Derricks components for an industry were the additional costs on any private-sector or Standard for Construction (29 CFR number of crane operators and the public-sector entity, and does not meet 1926.550) ICR (OMB Control Number number of jobs involving cranes. The any of the criteria for an economically 1218–0113) because the new ICR original FEA estimated that digger significant or major rule specified by superseded this ICR. In addition, OSHA derricks represented 85 percent of Executive Order 12866 and the relevant retitled the new ICR to Cranes and operators, and 85 percent of jobs statutes. This rule is not a ‘‘major rule’’ Derricks in Construction (29 CFR Part involving cranes. OSHA, therefore, under Section 804 of the Small Business 1926, Subpart CC and Subpart DD). estimates that digger derricks account Regulatory Enforcement Fairness Act of This proposed rule, which expands for 85 percent of the costs attributed to 1996 (5 U.S.C. 801 et seq.). the digger-derrick exemption, does not NAICS 221110 and NAICS 221120. OSHA developed this proposed rule require any additional collection of Applying this 85 percent factor to the consistent with the provisions of information or alter the substantive total costs for the industries yields costs Executive Orders 12866 and 13563. requirements detailed in the 2010 ICR. for digger derricks of $5.7 million per Accordingly, this proposed rule follows The only impact on the collection of year in NAICS 221110 and $15.9 million closely the principle of EO 13563 that information will be a reduction in the per year in NAICS 221120, for a total of agencies should use new data developed number of entities collecting 3 $21.6 million per year. after completion of a rulemaking information. Accordingly, OSHA does This proposed rule will eliminate (retrospective analysis) to determine if a not believe it is necessary to submit a nearly all of the estimated $21.6 million regulation ‘‘should be modified, new ICR to OMB. OSHA will identify streamlined, expanded, or repealed.’’ In any reduction in burden hours when it 3 Based on the size of digger derricks and EEI’s descriptions of digger-derrick activities, OSHA this case, review of data submitted after renews the ICR. understands that the vast majority of digger-derrick completion of the initial rulemaking Interested parties may comment on use for construction activity in the electric-utility provided OSHA with the opportunity to OSHA’s determination that this industry will involve transmission and distribution streamline a rule by dropping its proposal contains no additional work subject to subpart V of 29 CFR part 1926. paperwork requirements by sending Employers categorized under NAICS 221120 application to digger derricks, thereby generally conduct electric-transmission and saving the industry an estimated $21.6 their written comments to the Office of -distribution work. However, OSHA is including million per year. As described Information and Regulatory Affairs, digger derricks under NAICS 221110, which is the previously, this action removes duties Attn: OMB Desk Officer for OSHA, SIC code for power generation, because some Office of Management and Budget, employers may be under that SIC code because and costs for the electric-utility their primary work is in that area, but those industry, and does not impose any new Room 10235, 726 Jackson Place, NW., employers also may engage in transmission work duties on any employer. Because small Washington, DC 20503. The Agency also covered by subpart V. Because the record does not entities will have reduced costs as a encourages commenters to submit their indicate that employers use digger derricks for comments on this paperwork power-generation construction activities, OSHA result of this proposed rule, the Agency assumes that the use of digger derricks under certifies that the final standard would determination to OSHA, along with NAICS 221110 is for subpart V work. not impose significant economic costs their other comments on this proposed

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rule, within the specified comment developed from this proposed rule UMRA. OSHA’s standards do not apply period. would impact state policy options in the to state or local governments except in OSHA notes that a federal agency same manner as every standard states that have voluntarily adopted cannot conduct or sponsor a collection promulgated by OSHA. In states with state plans. OSHA further noted that the of information unless it is approved by OSHA-approved state plans, this rule imposed costs of over $100 million the Office of Management and Budget proposed rulemaking does not limit per year on the private sector and, (OMB) under the Paperwork Reduction state policy options. therefore, required review under the Act of 1995, 44 U.S.C. 3501 et seq. and F. State Plan States UMRA for those costs; the Agency the agency also displays a currently determined that its Final Economic valid OMB control number for the When federal OSHA promulgates a Analysis met that requirement. Id. collection of information, and that the new standard or more stringent As discussed above in Section IV.B. public need not respond to a collection amendment to an existing standard, the (Final Economic Analysis and Final of information requirement unless the 27 states and U.S. territories with their Regulatory Flexibility Act Analysis) of agency displays a currently valid OMB own OSHA-approved occupational this preamble, this proposed rule control number. Also, notwithstanding safety and health plans must amend reduces expenditures by private-sector any other provisions of law, no person their standards to reflect the new employers. For the purposes of the shall be subject to a penalty for failing standard or amendment, or show OSHA UMRA, OSHA certifies that this to comply with a collection of why such action is unnecessary, e.g., proposed rule does not mandate that information requirement if the because an existing state standard state, local, or tribal governments adopt requirement does not display a covering this area is at least as effective new, unfunded regulatory obligations, currently valid OMB control number. in protecting employees as the new or increase expenditures by the private federal standard or amendment (29 CFR E. Federalism sector of more than $100 million in any 1953.5(a)). The state standard must be at year. OSHA reviewed this proposed rule in least as effective in protecting accordance with the Executive Order on employees as the final federal rule. State H. Consultation and Coordination with Federalism (Executive Order 13132 (64 Plan States must issue the standard Indian Tribal Governments FR 43255 (Aug. 10, 1999))), which within six months of the promulgation OSHA reviewed this proposed rule in requires that Federal agencies, to the date of the final federal rule. When accordance with Executive Order 13175 extent possible, refrain from limiting OSHA promulgates a new standard or (65 FR 67249 (Nov. 9, 2000)), and state policy options, consult with states amendment that does not impose determined that it does not have ‘‘tribal prior to taking any actions that would additional or more stringent implications’’ as defined in that order. restrict state policy options, and take requirements than an existing standard, This proposed rule does not have such actions only when clear State Plan States are not required to substantial direct effects on one or more constitutional authority exists and the amend their standards, although OSHA Indian tribes, on the relationship problem is national in scope. Executive may encourage them to do so. The 27 between the federal government and Order 13132 provides for preemption of states and U.S. territories with OSHA- Indian tribes, or on the distribution of state law only with the expressed approved occupational safety and health power and responsibilities between the consent of Congress. Federal agencies plans are: Alaska, Arizona, California, federal government and Indian tribes. must limit any such preemption to the Hawaii, Indiana, Iowa, Kentucky, extent possible. Maryland, Michigan, Minnesota, List of Subjects in 29 CFR Part 1926 Under Section 18 of the OSH Act, Nevada, New Mexico, North Carolina, Cranes and derricks, Construction Congress expressly provides that states Oregon, Puerto Rico, South Carolina, industry, Occupational safety and may adopt, with federal approval, a plan Tennessee, Utah, Vermont, Virginia, health. for the development and enforcement of Washington, and Wyoming. occupational safety and health Connecticut, Illinois, New Jersey, New Authority and Signature standards. The OSH Act refers to states York, and the Virgin Islands have David Michaels, Ph.D., MPH, that obtain federal approval for such a OSHA-approved State Plans that apply Assistant Secretary of Labor for plan as ‘‘State Plan States’’ (29 U.S.C. to state and local government employees Occupational Safety and Health, U.S. 667). Occupational safety and health only. Department of Labor, 200 Constitution standards developed by State Plan The amendments made in this Ave. NW., Washington, DC 20210, States must be at least as effective in proposed rule do not impose any new authorized the preparation of this providing safe and healthful requirements on employers. notice. OSHA is issuing this direct final employment and places of employment Accordingly, State Plan States are not rule under the following authorities: 29 as the federal standards. Subject to these required to amend their standards to U.S.C. 653, 655, 657; 40 U.S.C. 3701 et requirements, State Plan States are free incorporate the expanded exemption seq.; 5 U.S.C. 553; Secretary of Labor’s to develop and enforce under state law specified in this proposal, but they may Order No. 1–2012 (77 FR 3912, Jan. 25, their own requirements for safety and do so if they so choose. health standards. 2012); and 29 CFR part 1911. OSHA previously concluded that its G. Unfunded Mandates Reform Act Signed at Washington, DC, on October 9, promulgation of subpart CC complies When OSHA issued the final rule for 2012. with Executive Order 13132 (75 FR Cranes and Derricks in Construction (75 David Michaels, 48128 and 48129). Because the current FR 48130), it reviewed the rule Assistant Secretary of Labor for Occupational rulemaking does not impose any according to the Unfunded Mandates Safety and Health. additional burdens, that analysis applies Reform Act of 1995 (UMRA; 2 U.S.C. Proposed Amendments to Standards to the revision of the digger-derrick 1501 et seq.) and Executive Order 13132 exemption. Therefore, this proposed (64 FR 43255 (Aug. 10, 1999)), and For the reasons stated in the preamble rule complies with Executive Order concluded that the final rule did not of this proposed rule, OSHA is 13132. In states without OSHA- meet the definition of a ‘‘Federal proposing to amend 29 CFR part 1926 approved state plans, any standard intergovernmental mandate’’ under the as follows:

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PART 1926—[AMENDED] DEPARTMENT OF HOMELAND Tables of Acronyms SECURITY CFR Code of Federal Regulations Subpart V—Power Transmission and DHS Department of Homeland Security Distribution Coast Guard FR Federal Register NPRM Notice of Proposed Rulemaking 1. Revise the authority citation for 33 CFR Part 117 § Section Symbol subpart V to read as follows: U.S.C. United States Code [Docket No. USCG–2012–0918] Authority: 40 U.S.C. 3701; 29 U.S.C. 653, A. Public Participation and Request for 655, 657; Secretary of Labor’s Order Nos. 12– Comments 71 (36 FR 8754); 8–76 (41 FR 25059); 9–83 RIN 1625–AA09 (48 FR 35736), 1–90 (55 FR 9033), 5–2007 (72 We encourage you to participate in Drawbridge Operation Regulation; FR 31159), or 1–2012 (77 FR 3912), as this rulemaking by submitting Lake Champlain, Swanton, VT applicable. Section 1926.951 also is issued comments and related materials. All comments received will be posted, under 29 CFR part 1911. AGENCY: Coast Guard, DHS. without change to http:// 2. Amend § 1926.952 by revising ACTION: Notice of proposed rulemaking. www.regulations.gov and will include paragraph (c)(2) to read as follows: any personal information you have SUMMARY: The Coast Guard proposes to § 1926.952 Mechanical equipment. modify the operating schedule that provided. * * * * * governs the New England Central 1. Submitting Comments Railroad Bridge across Missisquoi Bay, (c) * * * mile 105.6, at Swanton Vermont. The If you submit a comment, please (2) Use of digger derricks must owner of the bridge has requested to include the docket number for this comply with § 1910.269 (in addition to operate the bridge from a remote rulemaking (USCG–2012–0918), 29 CFR part 1926, subpart O) whenever location, at St. Albans, Vermont. It is indicate the specific section of this such use is excluded from 29 CFR part expected that this change to the document to which each comment 1926, subpart CC, in accordance with regulations would provide relief to the applies, and provide a reason for each § 1926.1400(c)(4). bridge owner from crewing the bridge suggestion or recommendation. You may submit your comments and * * * * * while continuing to meet the reasonable needs of navigation. material online (http:// www.regulations.gov), or by fax, mail or Subpart CC—Cranes and Derricks in DATES: Comments and related material hand delivery, but please use only one Construction must be received by the Coast Guard on of these means. If you submit a or before January 8, 2013. comment online via http:// 3. Revise the authority citation for ADDRESSES: You may submit comments www.regulations.gov, it will be subpart CC to read as follows: identified by docket number U.S.C.G.– considered received by the Coast Guard Authority: 40 U.S.C. 3701; 29 U.S.C. 653, 2012–0918 using any one of the when you successfully transmit the 655, 657; and Secretary of Labor’s Order No. following methods: comment. If you fax, hand deliver, or 5–2007 (72 FR 31159) or 1–2012 (77 FR (1) Federal Rulemaking Portal: mail your comment, it will be 3912), as applicable; and 29 CFR part 1911. http://www.regulations.gov. considered as having been received by (2) Fax: 202–493–2251. the Coast Guard when it is received at 4. Amend § 1926.1400 by revising (3) Mail or Delivery: Docket the Docket Management Facility. We paragraph (c)(4) to read as follows: Management Facility (M–30), U.S. recommend that you include your name Department of Transportation, West § 1926.1400 Scope. and a mailing address, an email address, Building Ground Floor, Room W12–140, or a phone number in the body of your * * * * * 1200 New Jersey Avenue SE., document so that we can contact you if (c) * * * Washington, DC 20590–0001. Deliveries we have questions regarding your (4) Digger derricks when used for accepted between 9 a.m. and 5 p.m., submission. Monday through Friday, except Federal augering holes for poles carrying electric To submit your comment online, go to holidays. The telephone number is 202– or telecommunication lines, placing and http://www.regulations.gov, click on the 366–9329. ‘‘submit a comment’’ box, which will removing the poles, and for handling See the ‘‘Public Participation and associated materials for installation on, then become highlighted in blue. In the Request for Comments’’ portion of the ‘‘Document Type’’ drop down menu or removal from, the poles, or when SUPPLEMENTARY INFORMATION section used for any other work subject to select ‘‘Proposed Rules’’ and insert below for instructions on submitting ‘‘USCG–2012–0918’’ in the ‘‘Keyword’’ subpart V of this part. To be eligible for comments. To avoid duplication, please this exclusion, digger-derrick use in box. Click ‘‘Search’’ then click on the use only one of these four methods. balloon shape in the ‘‘Actions’’ column. work subject to subpart V of this part FOR FURTHER INFORMATION CONTACT: If must comply with all of the provisions If you submit your comments by mail or you have questions on this proposed hand delivery, submit them in an of that subpart, and digger-derrick use rule, call or email Mr. John W. unbound format, no larger than 81⁄2 by in construction work for McDonald, Project Officer, First Coast 11 inches, suitable for copying and telecommunication service (as defined Guard District Bridge Program, electronic filing. If you submit them by at § 1910.268(s)(40)) must comply with telephone (617) 223–8364, email mail and would like to know that they all of the provisions of § 1910.268. [email protected]. If you have reached the Facility, please enclose a * * * * * questions on viewing or submitting stamped, self-addressed postcard or [FR Doc. 2012–27209 Filed 11–8–12; 8:45 am] material to the docket, call Renee V. envelope. We will consider all BILLING CODE 4510–26–P Wright, Program Manager, Docket comments and material received during Operations, telephone 202–366–9826. the comment period and may change SUPPLEMENTARY INFORMATION: the rule based on your comments.

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2. Viewing Comments and Documents after at least a twenty four hour notice that normally transit this bridge are in To view comments, as well as is given. winter storage. The Coast Guard received a request documents mentioned in this preamble As a result of the above information from the owner of the bridge, New as being available in the docket, go to the Coast Guard believes it is reasonable England Central Railroad Inc., to change http://www.regulations.gov, click on the for the bridge owner to operate the the drawbridge operation regulations to ‘‘read comments’’ box, which will then bridge from a remote location and that allow the bridge to be operated remotely become highlighted in blue. In the the reasonable needs of navigation will from the New England Central Railroad ‘‘Keyword’’ box insert ‘‘USCG–2012– continue to be addressed. Dispatcher’s Office located at St. 0918’’ and click ‘‘Search.’’ Click the Albans, Vermont. D. Discussion of Proposed Rule ‘‘Open Docket Folder’’ in the ‘‘Actions’’ The bridge had been operated column. You may also visit either the The Coast Guard proposes to revise 33 manually by hand crank since it was CFR 117.993(c), to allow remote Docket Management Facility in Room constructed in 1912. An operator would W12–140 on the ground floor of the operation of the New England Central be dispatched to the bridge to manually Railroad Bridge, and also eliminate Department of Transportation West close the draw to facilitate the passage Building, 1200 New Jersey Avenue SE., paragraph (d) under the same section of a train and then crank the draw back which governs the operation of the SR78 Washington, DC 20590, between 9 a.m. into the open position. and 5 p.m., Monday through Friday, highway bridge. The Federal Railroad Administration The SR78 highway bridge has been except Federal holidays. We have an funded the motorization of the bridge to agreement with the Department of replaced with a new fixed span highway allow remote operation of the bridge by bridge; therefore, the drawbridge Transportation to use the Docket New England Central Railroad. As a Management Facility. operations for that bridge will be result, in 2012, the operating system deleted because they are now obsolete 3. Privacy Act was modified by adding electric bridge and unnecessary. opening motors to swing the draw open For the of the New England Central Anyone can search the electronic and closed, a standby electric generator form of comments received into any of Railroad Bridge, the Coast Guard to be used in the event of a power received a request from the owner, New our dockets by the name of the outage, local bridge operation controls individual submitting the comment (or England Central Railroad Inc., to operate installed at the tenders building on the the bridge from a remote location at the signing the comment, if submitted on bridge to be used to locally operate the behalf of an association, business, labor New England Central railroad draw, LED navigation lights, and Dispatcher’s Office at St. Albans, union, etc.). You may review a Privacy electric illuminated signs both up and Act notice regarding our public dockets Vermont. down stream to warn mariners that the The existing drawbridge operations in the January 17, 2008, issue of the bridge will be closing for the passage of Federal Register (73 FR 3316). incorporated an operating schedule that an approaching train. listed the days and times the bridge 4. Public Meeting Presently, rail traffic crosses the would open for the passage of vessel bridge seven days a week. There are traffic. That operation schedule was We do not now plan to hold a public normally two train passages daily meeting. But you may submit a request established many years ago when the crossing the bridge in the morning and bridge was crewed. for one using one of the four methods returning later in the same day. In recent years the bridge was not specified under ADDRESSES. Please Under this notice of proposed crewed and didn’t operate according to explain why one would be beneficial. If rulemaking the bridge would be opened the operating schedule but rather it was we determine that one would aid this and closed remotely, from the New left in the open position during the rulemaking, we will hold one at a time England Central Railroad Dispatchers boating season June through September, and place announced by a later notice Office at St. Albans, Vermont. in the Federal Register. During the boating season, June 15 except when a train was scheduled to cross the bridge. Rail personnel would C. Basis and Purpose through September 15, the bridge would remain in the open position at all times, be dispatched to the bridge two hours in The New England Central Railroad except for the passage of rail traffic. advance of a train crossing to manually Bridge, formerly the Central Vermont Once rail traffic crosses the bridge the crank the draw closed to facilitate the Railway Bridge, at mile 105.6, across bridge would be returned to the full passage of the rail traffic and then return Missisquoi Bay, at Swanton, Vermont, open position. the bridge to the full open position once has a vertical clearance in the closed In the off season, September 16 the train cleared the bridge. position that ranges between 9.5 feet through June 14, the bridge would The bridge was motorized in 2012, to and zero feet depending on the time of remain in the closed position at all facilitate remote operation, and thereby year and other conditions. The times. eliminate the dispatching of personnel waterway users are predominantly The bridge would be opened for the back and forth daily to operate the seasonal recreational vessels. passage of vessel traffic September 16 bridge. The existing drawbridge operation through June 14, upon receipt of a Under this notice of proposed regulations are listed at 33 CFR twenty-four hour advance notice to rulemaking, as a result of operating the 117.993(c), which require the draw to open the bridge. draw remotely, the bridge will simply operate as follows: From June 15 The bridge opens on average two to remain in the open position at all times through September 15, the draw shall three times a week during the period 16 from June 15 through September 15, open on signal, Monday through Friday September through 14 June when the except for the passage of rail traffic. between 9 a.m. and 5 p.m. and on bridge owner proposes to open the draw From September 16 through June 14, the Saturday, Sunday, Independence Day, upon receipt of a twenty-four hour draw would remain in the closed and Labor Day, between 7 a.m. and 11 advance notice. position at all times, except for the p.m. At all other times, after at least a In addition, the waterway is normally passage of vessel traffic, that provides at two hour notice is given. From frozen December through April each least a twenty four hour notice to open September 16 through June 14, on signal winter when the recreational vessels the draw.

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The New England Central Railroad Assistance for Small Entities Constitutionally Protected Property Bridge is listed in the existing Under section 213(a) of the Small Rights. regulations as the Central Vermont Business Regulatory Enforcement 8. Civil Justice Reform Railway Bridge. We are changing the Fairness Act of 1996 (Pub. L. 104–121), name of the bridge under this proposed we want to assist small entities in This proposed rule meets applicable rule to update the present name and understanding this proposed rule. If the standards in sections 3(a) and 3(b)(2) of ownership of the bridge. rule would affect your small business, Executive Order 12988, Civil Justice Reform, to minimize litigation, E. Regulatory Analyses organization, or governmental jurisdiction and you have questions eliminate ambiguity, and reduce burden. We developed this proposed rule after concerning its provisions or options for considering numerous statutes and compliance, please contact the person 9. Protection of Children FOR FURTHER INFORMATION executive orders related to rulemaking. listed in the We have analyzed this proposed rule Below we summarize our analyses CONTACT, above. under Executive Order 13045, The Coast Guard will not retaliate based on 13 of these statutes or Protection of Children from against small entities that question or executive orders. Environmental Health Risks and Safety complain about this proposed rule or Risks. This rule is not an economically 1. Regulatory Planning and Review any policy or action of the Coast Guard. significant rule and would not create an This proposed rule is not a 3. Collection of Information environmental risk to health or risk to ‘‘significant regulatory action’’ under This proposed rule would call for no safety that might disproportionately section 3(f) of Executive Order 12866, new collection of information under the affect children. Regulatory Planning and Review, as Paperwork Reduction Act of 1995 (44 10. Indian Tribal Governments supplemented by Executive Order U.S.C. 3501–3520). 13563, Improving Regulation and This proposed rule does not have Regulatory Review, and does not require 4. Federalism tribal implications under Executive an assessment of potential costs and A rule has implications for federalism Order 13175, Consultation and benefits under section 6(a)(3) of Order under Executive Order 13132, Coordination with Indian Tribal 12866, or under section 1 of Executive Federalism, if it has a substantial direct Governments, because it would not have Order 13563 because the bridge will effect on the States, on the relationship a substantial direct effect on one or continue to operate under the same between the national government and more Indian tribes, on the relationship operation schedule, except that, it will the States, or on the distribution of between the Federal Government and be opened and closed from a remote power and responsibilities among the Indian tribes, or on the distribution of location. The Office of Management and various levels of government. We have power and responsibilities between the Budget has not reviewed it under those analyzed this proposed rule under that Federal Government and Indian tribes. Orders. Order and have determined that it does 11. Energy Effects not have implications for federalism. 2. Impact on Small Entities This proposed rule is not a 5. Protest Activities ‘‘significant energy action’’ under Under the Regulatory Flexibility Act Executive Order 13211, Actions (5 U.S.C. 601–612), we have considered The Coast Guard respects the First Concerning Regulations That the impact of this proposed rule on Amendment rights of protesters. Significantly Affect Energy Supply, small entities. The Coast Guard certifies Protesters are asked to contact the Distribution, or Use because it is not a under 5 U.S.C. 605(b) that this proposed person listed in the FOR FURTHER ‘‘significant regulatory action’’ under rule would not have a significant INFORMATION CONTACT section to Executive Order 12866, and is not likely economic impact on a substantial coordinate protest activities so that your to have a significant adverse effect on number of small entities. message can be received without jeopardizing the safety or security of the supply, distribution, or use of This proposed rule would affect the people, places or vessels. energy. The Administrator of the Offices following entities, some of which might of Information and Regulatory Affairs be small entities: The owners or 6. Unfunded Mandates Reform Act has not designated it as a significant operators of vessels needing to transit The Unfunded Mandates Reform Act energy action. Therefore, it does not through the bridge. of 1995 (2 U.S.C. 1531–1538) requires require a Statement of Energy Effects This action will not have a significant Federal agencies to assess the effects of under Executive Order 13211. their discretionary regulatory actions. In economic impact on a substantial 12. Technical Standards number of small entities for the particular, the Act addresses actions following reasons: that may result in the expenditure by a This proposed rule does not use State, local, or tribal government, in the technical standards. Therefore, we did The bridge will continue to operate aggregate, or by the private sector of not consider the use of voluntary under the same opening schedule, $100,000,000 (adjusted for inflation) or consensus standards. except that it will be opened and closed more in any one year. Though this from a remote location. 13. Environment proposed rule will not result in such an If you think that your business, expenditure, we do discuss the effects of We have analyzed this proposed rule organization, or governmental this rule elsewhere in this preamble. under Department of Homeland jurisdiction qualifies as a small entity Security Management Directive 023–01, and that this rule would have a 7. Taking of Private Property and Commandant Instruction significant economic impact on it, This proposed rule would not cause a M16475.lD which guides the Coast please submit a comment (see taking of private property or otherwise Guard in complying with the National ADDRESSES) explaining why you think it have taking implications under Environmental Policy Act of 1969 qualifies and how and to what degree Executive Order 12630, Governmental (NEPA)(42 U.S.C. 4321–4370f), and this rule would economically affect it. Actions and Interference with have made a preliminary determination

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that this action is one of a category of traffic that the bridge will be closing, ENVIRONMENTAL PROTECTION actions which do not individually or shall also be maintained in good AGENCY cumulatively have a significant effect on working order at all times. In the event the human environment. This proposed that any of the cameras, navigation 40 CFR Part 52 rule simply promulgates the operating lights, horn, or message board become [EPA–R09–OAR–2012–0790; FRL–9750–2] regulations or procedures for disabled, personnel shall be deployed to drawbridges. This rule is categorically the bridge to be on scene within two Revisions to the California State excluded, under figure 2–1, paragraph hours from the known time of the Implementation Plan, Placer County (32)(e), of the Instruction. equipment failure. Air Pollution Control District Under figure 2–1, paragraph (32)(e), of the Instruction, an environmental (5) The draw may operate remotely as AGENCY: Environmental Protection analysis checklist and a categorical follows: Once it is determined that the Agency (EPA). exclusion determination are not draw must be opened or closed, the ACTION: Proposed rule. required for this rule. We seek any train dispatcher shall observe the comments or information that may lead waterway both up and down stream via SUMMARY: EPA is proposing to approve to the discovery of significant the infrared cameras to verify that the revisions to the Placer County Air environmental impact from the channel is clear of all approaching Pollution Control District (PCAPCD) proposed rule. vessel traffic. All approaching vessel portion of the California State traffic shall be allowed to pass before Implementation Plan (SIP). These List of Subjects in 33 CFR Part 117 the bridge may closed. Once it is revisions concern oxides of nitrogen Bridges. determined that no vessel traffic is (NOx) emissions from biomass boilers. For the reasons discussed in the approaching the dispatcher shall sound We are approving a local rule that preamble, the Coast Guard proposes to the warning horn and activate the up regulates these emission sources under amend 33 CFR part 117 as follows: and down stream message boards the Clean Air Act (CAA or the Act). We indicating that the bridge will be are taking comments on this proposal PART 117—DRAWBRIDGE and plan to follow with a final action. OPERATION REGULATIONS closing. After at least a one minute delay the draw may then be closed and DATES: Any comments must arrive by 1. The authority citation for part 117 the swing span navigation lights shall December 10, 2012. continues to read as follows: display as red to indicate the bridge is ADDRESSES: Submit comments, Authority: 33 U.S.C. 499; 33 CFR 1.05–1; in the closed position. Once the train identified by docket number EPA–R09– Department of Homeland Security Delegation clears the bridge the draw shall be OAR–2012–0790, by one of the No. 0170.1. returned to the full open position and following methods: 1. Federal eRulemaking Portal: 2. Revise § 117.993 paragraph (c) and the swing span lights shall display as www.regulations.gov. Follow the on-line remove paragraph (d) to read as follows: green to indicate the draw is in the full open position. instructions. § 117.993 Lake Champlain. 2. Email: [email protected]. (6) In the event that the dispatcher 3. Mail or deliver: Andrew Steckel * * * * * cannot verify that the channel is clear of (c) The draw of the New England (Air–4), U.S. Environmental Protection all vessel traffic and the bridge cannot Central Railroad Bridge across Agency Region IX, 75 Hawthorne Street, Missiquoi Bay, mile 105.6, at Swanton, be safely closed, an on-scene train San Francisco, CA 94105–3901. Vermont, shall operate as follows: crewmember shall observe the waterway Instructions: All comments will be (1) From June 15 through September for any vessel traffic and then included in the public docket without 15, the draw shall remain in the full communicate with the train dispatch change and may be made available open position at all times and shall only office either by radio or telephone to online at www.regulations.gov, be closed for the passage of rail traffic request the bridge be safely closed. including any personal information or the performance of maintenance Personnel shall then be deployed to the provided, unless the comment includes authorized in accordance with subpart bridge to arrive within two hours to Confidential Business Information (CBI) A of this part. inspect and repair the bridge remote or other information whose disclosure is (2) From September 16 through June operation equipment. The bridge shall restricted by statute. Information that 14, the draw may remain in the closed be operated manually from the tender’s you consider CBI or otherwise protected position and shall be opened on signal house located at the bridge until all should be clearly identified as such and for the passage of vessel traffic after at necessary repairs are completed to the should not be submitted through least a twenty four hour notice is given remote operation equipment. www.regulations.gov or email. by calling the number posted at the www.regulations.gov is an ‘‘anonymous * * * * * bridge. access’’ system, and EPA will not know (3) The draw may be operated either Dated: October 16, 2012. your identity or contact information remotely by the New England Central Daniel B. Abel, unless you provide it in the body of Railroad train dispatcher located at St. Rear Admiral, U.S. Coast Guard, Commander, your comment. If you send email Albans, Vermont or manually by a draw First Coast Guard District. directly to EPA, your email address will be automatically captured and included tender located at the bridge. [FR Doc. 2012–27369 Filed 11–8–12; 8:45 am] (4) A sufficient number of infrared as part of the public comment. If EPA cameras shall be maintained in good BILLING CODE 9110–04–P cannot read your comment due to working order at all times with a clear technical difficulties and cannot contact unobstructed view of the channel under you for clarification, EPA may not be the bridge, and the up and down stream able to consider your comment. approaches to the bridge. A signal horn Docket: Generally, documents in the and message boards located both up and docket for this action are available down stream, necessary to warn marine electronically at www.regulations.gov

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and in hard copy at EPA Region IX, 75 FOR FURTHER INFORMATION CONTACT: B. Does the rule meet the evaluation Hawthorne Street, San Francisco, Idalia Pe´rez, EPA Region IX, (415) 972– criteria? California. While all documents in the 3248, [email protected]. C. EPA Recommendations To Further Improve the Rule docket are listed at SUPPLEMENTARY INFORMATION: D. Public Comment and Final Action www.regulations.gov, some information Throughout this document, ‘‘we,’’ ‘‘us’’ III. Statutory and Executive Order Reviews may be publicly available only at the and ‘‘our’’ refer to EPA. hard copy location (e.g., copyrighted I. The State’s Submittal Table of Contents material, large maps), and some may not A. What rule did the State submit? be publicly available in either location I. The State’s Submittal (e.g., CBI). To inspect the hard copy A. What rule did the State submit? Table 1 lists the rule addressed by this B. Are there other versions of this rule? materials, please schedule an C. What is the purpose of the submitted proposal with the dates that it was appointment during normal business rule? adopted by the local air agency and hours with the contact listed in the FOR II. EPA’s Evaluation and Action. submitted by the California Air FURTHER INFORMATION CONTACT section. A. How is EPA evaluating the rule? Resources Board.

TABLE 1—SUBMITTED RULE

Local agency Rule No. Rule title Amended Submitted

PCAPCD ...... 233 Biomass Boilers...... 06/14/12 09/21/12

On October 11, 2012, EPA determined RACT requirements consistently rule but are not currently the basis for that the submittal for PCAPCD Rule 233 include the following: rule disapproval. met the completeness criteria in 40 CFR 1. ‘‘State Implementation Plans; D. Public Comment and Final Action Part 51 Appendix V, which must be met Nitrogen Oxides Supplement to the before formal EPA review. General Preamble; Clean Air Act Because EPA believes the submitted Amendments of 1990 Implementation of rule fulfills all relevant requirements, B. Are there other versions of this rule? Title I; Proposed Rule,’’ (the NOX we are proposing to fully approve it as We finalized a limited approval and Supplement), 57 FR 55620, November described in section 110(k)(3) of the Act. limited disapproval of an earlier version 25, 1992. We will accept comments from the of Rule 233 on January 19, 2012 (77 FR 2. ‘‘Issues Relating to VOC Regulation public on this proposal for the next 30 2643). That action incorporated Rule Cutpoints, Deficiencies, and days. Unless we receive convincing new 233 into the California SIP, including Deviations,’’ EPA, May 25, 1988 (the information during the comment period, those provisions identified as deficient. Bluebook). we intend to publish a final approval 3. ‘‘Guidance Document for Correcting action that will incorporate this rule C. What is the purpose of the submitted Common VOC & Other Rule into the federally enforceable SIP. Final rule? Deficiencies,’’ EPA Region 9, August 21, approval of Rule 233 would satisfy 2001 (the Little Bluebook). NOX helps produce ground-level California’s obligation to implement 4. ‘‘Determination of Reasonably RACT under CAA section 182 for this ozone, smog and particulate matter, Available Control Technology and Best which harm human health and the source category and thereby terminate Available Retrofit Control Technology both the sanctions clocks and the environment. Section 110(a) of the CAA for Industrial, Institutional, and requires States to submit regulations Federal Implementation Plan (FIP) clock Commercial Boilers, Steam Generators, associated with limited approval and that control NOX emissions. Rule 233 and Process Heaters,’’ CARB, July 18, limits NOX emissions from biomass limited disapproval of this rule which 1991. we finalized on January 19, 2012 (77 FR boilers. EPA’s technical support 5. ‘‘Alternative Control Techniques document (TSD) has more information 2643). Document—NOX Emissions from about this rule. Industrial/Commercial/Institutional III. Statutory and Executive Order II. EPA’s Evaluation and Action (ICI) Boilers,’’ U.S. EPA 453/R–94–022, Reviews March 1994. Under the Clean Air Act, the A. How is EPA evaluating the rule? 6. ‘‘Alternative Control Techniques Administrator is required to approve a Document—NO Emissions from Utility Generally, SIP rules must be X SIP submission that complies with the Boilers,’’ US EPA 452/R–93–008, March enforceable (see section 110(a) of the provisions of the Act and applicable 1994. Act), must require Reasonably Available Federal regulations. 42 U.S.C. 7410(k); Control Technology (RACT) for each B. Does the rule meet the evaluation 40 CFR 52.02(a). Thus, in reviewing SIP category of sources covered by a Control criteria? submissions, EPA’s role is to approve Techniques Guidelines (CTG) document We believe this rule is consistent with State choices, provided that they meet as well as each major source in the relevant policy and guidance the criteria of the Clean Air Act. nonattainment areas (see sections regarding enforceability, RACT, and SIP Accordingly, this proposed action 182(b)(2) and 182(f)), and must not relax relaxations. The TSD has more merely proposes to approve State law as existing requirements (see sections information on our evaluation. meeting Federal requirements and does 110(l) and 193). The PCAPCD regulates not impose additional requirements an ozone nonattainment area (see 40 C. EPA Recommendations To Further beyond those imposed by State law. For CFR part 81), so Rule 233 must fulfill Improve the Rule that reason, this proposed action: RACT. The TSD describes additional rule • Is not a ‘‘significant regulatory Guidance and policy documents that revisions that we recommend for the action’’ subject to review by the Office we use to evaluate enforceability and next time the local agency modifies the of Management and Budget under

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Executive Order 12866 (58 FR 51735, Authority: 42 U.S.C. 7401 et seq. Emergency Management Agency, 500 C October 4, 1993); Dated: October 30, 2012. Street SW., Washington, DC 20472, • Does not impose an information Jared Blumenfeld, (202) 646–4064 or (email) Luis. collection burden under the provisions Regional Administrator, Region IX. [email protected]. of the Paperwork Reduction Act (44 [FR Doc. 2012–27324 Filed 11–8–12; 8:45 am] SUPPLEMENTARY INFORMATION: The U.S.C. 3501 et seq.); Federal Emergency Management Agency • BILLING CODE 6560–50–P Is certified as not having a (FEMA) publishes proposed significant economic impact on a determinations of Base (1% annual- substantial number of small entities chance) Flood Elevations (BFEs) and DEPARTMENT OF HOMELAND under the Regulatory Flexibility Act (5 modified BFEs for communities SECURITY U.S.C. 601 et seq.); participating in the National Flood • Does not contain any unfunded Insurance Program (NFIP), in mandate or significantly or uniquely Federal Emergency Management Agency accordance with section 110 of the affect small governments, as described Flood Disaster Protection Act of 1973, in the Unfunded Mandates Reform Act 44 CFR Part 67 42 U.S.C. 4104, and 44 CFR 67.4(a). of 1995 (Pub. L. 104–4); These proposed BFEs and modified • Does not have Federalism [Docket ID FEMA–2011–0002; Internal BFEs, together with the floodplain implications as specified in Executive Agency Docket No. FEMA–B–1233] management criteria required by 44 CFR Order 13132 (64 FR 43255, August 10, 60.3, are minimum requirements. They Proposed Flood Elevation 1999); should not be construed to mean that • Determinations Is not an economically significant the community must change any regulatory action based on health or AGENCY: Federal Emergency existing ordinances that are more safety risks subject to Executive Order Management Agency, DHS. stringent in their floodplain 13045 (62 FR 19885, April 23, 1997); • ACTION: Proposed rule; correction. management requirements. The Is not a significant regulatory action community may at any time enact subject to Executive Order 13211 (66 FR SUMMARY: On November 29, 2011 FEMA stricter requirements of its own or 28355, May 22, 2001); published in the Federal Register a pursuant to policies established by other • Is not subject to requirements of proposed rule that contained an Federal, State, or regional entities. Section 12(d) of the National erroneous table. This document These proposed elevations are used to Technology Transfer and Advancement provides corrections to that table, to be meet the floodplain management Act of 1995 (15 U.S.C. 272 note) because used in lieu of the information requirements of the NFIP and also are application of those requirements would published at 76 FR 73537. The table used to calculate the appropriate flood be inconsistent with the Clean Air Act; provided here represents the flooding insurance premium rates for new and sources, location of referenced buildings built after these elevations are • Does not provide EPA with the elevations, effective and modified made final, and for the contents in those discretionary authority to address elevations, and communities affected for buildings. disproportionate human health or Sullivan County, Pennsylvania (All environmental effects with practical, Correction Jurisdictions). Specifically, it addresses appropriate, and legally permissible the flooding sources Big Run, Little In the proposed rule published at 76 methods under Executive Order 12898 Loyalsock Creek, Loyalsock Creek, and FR 73537, in the November 29, 2011, (59 FR 7629, February 16, 1994). Muncy Creek. issue of the Federal Register, FEMA In addition, this proposed action does DATES: Comments are to be submitted published a table under the authority of not have tribal implications as specified on or before February 7, 2013. 44 CFR 67.4. The table, entitled by Executive Order 13175 (65 FR 67249, ‘‘Sullivan County, Pennsylvania (All ADDRESSES: You may submit comments, November 9, 2000), because the SIP is Jurisdictions)’’ addressed the flooding identified by Docket No. FEMA–B– not approved to apply in Indian country sources Big Run, Little Loyalsock Creek, 1233, to Luis Rodriguez, Chief, located in the State, and EPA notes that Loyalsock Creek, and Muncy Creek. Engineering Management Branch, it will not impose substantial direct That table contained inaccurate Federal Insurance and Mitigation costs on tribal governments or preempt information as to the location of Administration, Federal Emergency tribal law. referenced elevation, effective and Management Agency, 500 C Street SW., modified elevation in feet, and/or List of Subjects in 40 CFR Part 52 Washington, DC 20472, (202) 646–4064 communities affected for Loyalsock Environmental protection, Air or (email) [email protected]. Creek. In this document, FEMA is pollution control, Incorporation by gov. publishing a table containing the reference, Intergovernmental relations, FOR FURTHER INFORMATION CONTACT: Luis accurate information, to address these Nitrogen dioxide, Ozone, Particulate Rodriguez, Chief, Engineering prior errors. The information provided matter, Reporting and recordkeeping Management Branch, Federal Insurance below should be used in lieu of that requirements. and Mitigation Administration, Federal previously published.

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* Elevation in feet (NGVD) + Elevation in feet (NAVD) # Depth in feet Flooding source(s) Location of referenced elevation ** above ground Communities affected ∧ Elevation in meters (MSL) Effective Modified

Sullivan County, Pennsylvania (All Jurisdictions)

Big Run ...... At the Muncy Creek confluence ...... +968 +965 Township of Davidson. Approximately 1,600 feet upstream of Fairman Road None +1153 Little Loyalsock Creek ...... Approximately 1,150 feet downstream of the Marsh None +1432 Borough of Dushore. Run confluence. Approximately 540 feet upstream of Main Street ...... None +1458 Loyalsock Creek ...... Approximately 2.6 miles downstream of the Ogdonia +789 +780 Borough of Forksville, Creek confluence. Township of Elkland, Township of Forks, Township of Hillsgrove. At the Little Loyalsock Creek confluence ...... None +1004 Muncy Creek ...... At the Muncy Creek Tributary 1 confluence ...... +787 +783 Township of Davidson, Township of Shrews- bury. Approximately 0.76 mile upstream of Pecks Road ...... +991 +988

* National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ∧ Mean Sea Level, rounded to the nearest 0.1 meter. ** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the ref- erenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed. Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472. ADDRESSES Borough of Dushore Maps are available for inspection at the Municipal Building, 216 Julia Street, Dushore, PA 18614. Borough of Forksville Maps are available for inspection at Sullivan County Planning and Community Development, 245 Muncy Street, Suite 110, Laporte, PA 18626. Township of Davidson Maps are available for inspection at the Davidson Township Municipal Building, 20 Michelle Road, Muncy Valley, PA 17758. Township of Elkland Maps are available for inspection at the Elkland Township Municipal Office Building, 909 Kobbe Road, Forksville, PA 18616. Township of Forks Maps are available for inspection at the Forks Township Hall, 627 Molyneux Hill Road, Dushore, PA 18614. Township of Hillsgrove Maps are available for inspection at the Township Hall, 2232 Route 87, Hillsgrove, PA 18619. Township of Shrewsbury Maps are available for inspection at the Shrewsbury Township Building, 1793 Edkin Hill Road, Muncy Valley, PA 17758.

(Catalog of Federal Domestic Assistance No. DEPARTMENT OF HOMELAND a proposed rule that contained an 97.022, ‘‘Flood Insurance.’’) SECURITY erroneous table. This document Dated: October 12, 2012. provides corrections to that table, to be Federal Emergency Management James A. Walke, used in lieu of the information Agency published at 76 FR 70397. The table Acting Deputy Associate Administrator for provided here represents the flooding Mitigation, Department of Homeland 44 CFR Part 67 Security, Federal Emergency Management sources, location of referenced Agency. [Docket ID FEMA–2011–0002; Internal elevations, effective and modified Agency Docket No. FEMA–B–1229] [FR Doc. 2012–27365 Filed 11–8–12; 8:45 am] elevations, and communities affected for Sauk County, Wisconsin, and BILLING CODE 9110–12–P Proposed Flood Elevation Incorporated Areas. Specifically, it Determinations addresses the following flooding AGENCY: Federal Emergency sources: Baraboo River, Devil’s Lake Management Agency, DHS. Tributary (backwater effects from ACTION: Proposed rule; correction. Baraboo River), Hay Creek (backwater effects from Baraboo River), Little SUMMARY: On November 14, 2011, Baraboo River (backwater effects from FEMA published in the Federal Register Baraboo River), Narrows Creek

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(backwater effect from Baraboo River), chance) Flood Elevations (BFEs) and Correction Plum Creek (backwater effects from modified BFEs for communities Baraboo River), and Seeley Creek participating in the National Flood In the proposed rule published at 76 (backwater effects from Baraboo River). Insurance Program (NFIP), in FR 70397, in the November 14, 2011, DATES: Comments are to be submitted accordance with section 110 of the issue of the Federal Register, FEMA on or before February 7, 2013. Flood Disaster Protection Act of 1973, published a table under the authority of 44 CFR 67.4. The table, entitled ‘‘Sauk ADDRESSES: You may submit comments, 42 U.S.C. 4104, and 44 CFR 67.4(a). County, Wisconsin, and Incorporated identified by Docket No. FEMA–B– These proposed BFEs and modified Areas’’ addressed the flooding sources: 1229, to Luis Rodriguez, Chief, BFEs, together with the floodplain Baraboo River, Devil’s Lake Tributary Engineering Management Branch, management criteria required by 44 CFR Federal Insurance and Mitigation (backwater effects from Baraboo River), 60.3, are minimum requirements. They Hay Creek (backwater effects from Administration, Federal Emergency should not be construed to mean that Management Agency, 500 C Street SW., Baraboo River), Little Baraboo River the community must change any (backwater effects from Baraboo River), Washington, DC 20472, (202) 646–4064 existing ordinances that are more or (email) Narrows Creek (backwater effect from stringent in their floodplain [email protected]. Baraboo River), Plum Creek (backwater management requirements. The effects from Baraboo River), and Seeley FOR FURTHER INFORMATION CONTACT: Luis community may at any time enact Creek (backwater effects from Baraboo Rodriguez, Chief, Engineering stricter requirements of its own or River). That table contained inaccurate Management Branch, Federal Insurance pursuant to policies established by other information as to the location of and Mitigation Administration, Federal Federal, State, or regional entities. referenced elevation, effective and Emergency Management Agency, 500 C These proposed elevations are used to modified elevation in feet, and/or Street SW., Washington, DC 20472, meet the floodplain management communities affected for the Baraboo (202) 646–4064 or (email) requirements of the NFIP and also are River. In this document, FEMA is [email protected]. used to calculate the appropriate flood publishing a table containing the SUPPLEMENTARY INFORMATION: The insurance premium rates for new accurate information, to address these Federal Emergency Management Agency buildings built after these elevations are prior errors. The information provided (FEMA) publishes proposed made final, and for the contents in those below should be used in lieu of that determinations of Base (1% annual- buildings. previously published.

* Elevation in feet (NGVD) + Elevation in feet (NAVD) #Depth in feet Flooding source(s) Location of referenced elevation ** above ground Communities affected ∧ Elevation in meters (MSL) Effective Modified

Sauk County, Wisconsin and Incorporated Areas

Baraboo River ...... At the Columbia County boundary ...... +802 +804 City of Baraboo, City of Reedsburg, Unincor- porated Areas of Sauk County, Village of La Valle, Village of North Freedom, Village of Rock Springs, Village of West Baraboo At the Juneau County boundary ...... +910 +912 Devil’s Lake Tributary (back- At the Baraboo River confluence ...... +819 +820 City of Baraboo water effects from Baraboo River). Approximately 780 feet downstream of Old Lake +819 +820 Road. Hay Creek (backwater effects Approximately 75 feet downstream of County High- +881 +882 City of Reedsburg, Unin- from Baraboo River). way V. corporated Areas of Sauk County Approximately 1,860 feet upstream of County High- +881 +882 way V. Little Baraboo River (back- At the Baraboo River confluence ...... +892 +895 Unincorporated Areas of water effects from Baraboo Sauk County, Village of River). La Valle Approximately 70 feet downstream of State Highway +892 +895 58. Narrows Creek (backwater At the Baraboo River confluence ...... +870 +872 Unincorporated Areas of effects from Baraboo Sauk County, Village of River). Rock Springs At the downstream side of State Highway 154 ...... +870 +872 Plum Creek (backwater ef- At the Baraboo River confluence ...... +909 +912 Unincorporated Areas of fects from Baraboo River). Sauk County Approximately 0.78 mile upstream of the Baraboo +911 +912 River confluence.

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* Elevation in feet (NGVD) + Elevation in feet (NAVD) #Depth in feet Flooding source(s) Location of referenced elevation ** above ground Communities affected ∧ Elevation in meters (MSL) Effective Modified

Seeley Creek (backwater ef- At the Baraboo River confluence ...... +864 +865 Unincorporated Areas of fects from Baraboo River). Sauk County Approximately 1,450 feet downstream of Freedom +864 +865 Road.

* National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ∧ Mean Sea Level, rounded to the nearest 0.1 meter. ** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the ref- erenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed. Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emer- gency Management Agency, 500 C Street SW., Washington, DC 20472. ADDRESSES City of Baraboo Maps are available for inspection at City Hall, 135 4th Street, Baraboo, WI 53913. City of Reedsburg Maps are available for inspection at City Hall, 134 South Locust Street, Reedsburg, WI 53959. Unincorporated Areas of Sauk County Maps are available for inspection at West Square Building, 505 Broadway, Baraboo, WI 53913. Village of La Valle Maps are available for inspection at Village Hall, 103 West Main Street, La Valle, WI 53941. Village of North Freedom Maps are available for inspection at Village Hall, 103 North Maple Street, North Freedom, WI 53951. Village of Rock Springs Maps are available for inspection at Village Hall, 101 1st Street, Rock Springs, WI 53961. Village of West Baraboo Maps are available for inspection at Village Hall, 500 Cedar Street, Baraboo, WI 53913.

(Catalog of Federal Domestic Assistance No. ACTION: Availability of amendment to a search box. Locate the document you 97.022, ‘‘Flood Insurance.’’) fishery management plan; request for wish to comment on from the resulting Dated: October 23, 2012. comments. list and click on the ‘‘Submit a James A. Walke, Comment’’ icon on the right of that line. SUMMARY: NMFS announces that the • Mail: William W. Stelle, Jr., Acting Deputy Associate Administrator for Pacific Fishery Management Council Mitigation, Department of Homeland Regional Administrator, Northwest Security, Federal Emergency Management (Council) has transmitted Amendment Region, NMFS, 7600 Sand Point Way Agency. 17 to the Pacific Coast Salmon Fishery NE., Seattle, WA 98115–0070 or to Rod [FR Doc. 2012–27367 Filed 11–8–12; 8:45 am] Management Plan (FMP) for Secretarial McInnis, Regional Administrator, review. Amendment 17 revises the BILLING CODE 9110–12–P Southwest Region, NMFS, 501 West maximum fishing mortality threshold Ocean Boulevard, Suite 4200, Long (MFMT) for Quillayute fall coho, revises Beach, CA 90802–4213. the FMP to correct typographical errors, • Fax: 206–526–6736 Attn: Peggy DEPARTMENT OF COMMERCE updates reporting measures to reflect Mundy, or 562–980–4047 Attn: Heidi new technology, and updates or National Oceanic and Atmospheric Taylor. removes other obsolete or unnecessary Administration language. Instructions: Comments must be submitted by one of the above methods 50 CFR Part 660 DATES: Comments on Amendment 17 to ensure that the comments are must be received on or before January 8, received, documented, and considered RIN 0648–BC28 2013. by NMFS. Comments sent by any other Fisheries Off West Coast States; West ADDRESSES: You may submit comments, method, to any other address or Coast Salmon Fisheries; Notice of identified by NOAA–NMFS–2012–0192, individual, or received after the end of by any one of the following methods: the comment period, may not be Availability for Amendment 17 to the • Salmon Fishery Management Plan Electronic Submissions: Submit all considered. All comments received are electronic public comments via the a part of the public record and will AGENCY: National Marine Fisheries Federal e-Rulemaking Portal http:// generally be posted for public viewing Service (NMFS), National Oceanic and www.regulations.gov. To submit on http://www.regulations.gov without Atmospheric Administration (NOAA), comments via the e-Rulemaking Portal, change. All personal identifying Commerce. enter NOAA–NMFS–2011–0227 in the information (e.g., name, address, etc.)

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submitted voluntarily by the sender will plan amendment it prepares to NMFS MFMT for Quillayute coho and well as be publicly accessible. Do not submit for review and approval, disapproval, or the other, largely editorial, revisions. confidential business information or partial approval. The MSRA also NMFS welcomes comments on the otherwise sensitive or protected requires that NMFS, upon receiving an proposed FMP amendment through the information. NMFS will accept FMP or amendment, immediately end of the comment period. The Council anonymous comments (enter N/A in the publish a notice that the FMP or also transmitted a proposed rule to required fields if you wish to remain amendment is available for public implement Amendment 17 for anonymous). Attachments to electronic review and comment. NMFS will Secretarial review and approval. NMFS comments will be accepted in Microsoft consider the public comments received expects to publish and request public Word, Excel, WordPerfect, or Adobe during the comment period described review and comment on this rule in the PDF file formats only. above in determining whether to near future. Public comments on the Electronic copies of the amendment approve Amendment 17 to the FMP. proposed rule must be received by the may be obtained from the Council Web In 2011, the Council transmitted end of the comment period on the site at http://pcouncil.org. Salmon FMP Amendment 16 to NMFS amendment to be considered in the FOR FURTHER INFORMATION CONTACT: (76 FR 57945, September 19, 2011). approval/disapproval decision on the Peggy Mundy at 206–526–4323, or Heidi NMFS partially approved Amendment amendment. All comments received by Taylor at 562–980–4039. 16 in December 2011. NMFS the end of the comment period for the SUPPLEMENTARY INFORMATION: disapproved the proposed maximum amendment, whether specifically The ocean salmon fisheries in the fishing mortality threshold (MFMT) for directed to the amendment or the exclusive economic zone off Quillayute coho. During the review of proposed rule, will be considered in the Washington, Oregon, and California are Amendment 16, a variety of other issues approval/disapproval decision. managed under a ‘‘framework’’ fishery in the FMP were identified as needing Authority: 16 U.S.C. 1801 et seq. management plan entitled the Pacific revision, largely to correct typographical Coast Salmon Fishery Management Plan errors, update notification and reporting Dated: November 5, 2012. (FMP). The Magnuson-Stevens Fishery measures to reflect new technology, and Emily H. Menashes, Conservation and Management remove an unnecessary post-final rule Deputy Director, Office of Sustainable Reauthorization Act of 2006 (MSRA) comment period from the schedule for Fisheries, National Marine Fisheries Service. requires that each regional fishery annual management measures. [FR Doc. 2012–27473 Filed 11–8–12; 8:45 am] management council submit any FMP or Amendment 17 addresses the issue of BILLING CODE 3510–22–P

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Notices Federal Register Vol. 77, No. 218

Friday, November 9, 2012

This section of the FEDERAL REGISTER Title: Agricultural Foreign Investment addresses when provided, will be a contains documents other than rules or Disclosure Act Report. matter of public record. Comments will proposed rules that are applicable to the OMB Control Number: 0560–0097. be summarized and included in the public. Notices of hearings and investigations, Expiration Date of Approval: April 30, submission for the Office of committee meetings, agency decisions and 2013. Management and Budget approval. rulings, delegations of authority, filing of petitions and applications and agency Type of Request: Extension of a Signed on September 20, 2012. statements of organization and functions are currently approved information Carolyn B. Cooksie, collection. examples of documents appearing in this Acting Administrator, Farm Service Agency. section. Abstract: AFIDA requires foreign persons who hold, acquire, or dispose of [FR Doc. 2012–27393 Filed 11–8–12; 8:45 am] any interest in U.S. agricultural land to BILLING CODE 3410–05–P DEPARTMENT OF AGRICULTURE report the transactions to FSA on an AFIDA report (FSA–153). The DEPARTMENT OF AGRICULTURE Farm Service Agency information collected is made available to States. Also, although not required by Information Collection: Agricultural Farm Service Agency law, the information collected from the Foreign Investment Disclosure Act AFIDA reports is used to prepare an Information Collection Request, AGENCY: Farm Service Agency, USDA. annual report to Congress and the Servicing Minor Program Loans ACTION: Notice; request for comments. President concerning the effect of foreign investment upon family farms AGENCY: Farm Service Agency, USDA. SUMMARY: In accordance with the and rural communities so that Congress ACTION: Notice and request for Paperwork Reduction Act of 1995, the may review the annual report and comments. Farm Service Agency (FSA) is decide if further regulatory action is SUMMARY: In accordance with the requesting comments from all interested required. Paperwork Reduction Act of 1995, the individuals and organizations on the Estimate of Average Time to Respond: Farm Service Agency (FSA) is extension of a currently approved 0.476 hours per response. requesting comments from all interested information collection associated with Respondents: Foreign investors, individuals and organizations on an the Agricultural Foreign Investment corporate employees, attorneys, or farm extension of a currently approved Disclosure Act (AFIDA) of 1978. managers. information collection to support the DATES: We will consider comments that Estimated Number of Respondents: FSA Farm Loan Programs (FLP). we receive by January 8, 2013. 5,525. DATES: We will consider comments that ADDRESSES: We invite you to submit Estimated Number of Responses per comments on this notice. In your Respondent: 1. we receive by January 8, 2013. comments, include date, volume, and Estimated Number of Responses: ADDRESSES: We invite you to submit page number of this issue of the Federal 5,525. comments on this notice. In your Register. You may submit comments by Estimated Total Annual Burden on comments, include the date, volume, any of the following methods: Respondents: 2,631.25 hours. and page number of this issue of the • Federal eRulemaking Portal: Go to We are requesting comments on all Federal Register, the OMB control http://www.regulations.gov. Follow the aspects of this information collection to number and the title of the information online instructions for submitting help us to: collection. You may submit comments comments. (1) Determine whether the continued by any of the following methods: • • Mail: Lesa A. Johnson, Agricultural collection of information is still Federal eRulemaking Portal: Go to Foreign Investment Disclosure Act necessary for the proper performance of http://www.regulations.gov. Follow the (AFIDA) Program Manager, Natural the functions of the FSA, including online instructions for submitting Resources Analysis Group, Economic whether the information will have comments. • and Policy Analysis Staff, USDA, FSA, practical utility; Email: STOP 0531, 1400 Independence Avenue (2) Assess the accuracy of the FSA’s [email protected]. SW., Washington, DC 20250–0531. estimate of burden including the You may also send comments to the • Email: [email protected]. validity of the methodology and Desk Officer for Agriculture, Office of You may also send comments to the assumptions used; Information and Regulatory Affairs, Desk Officer for Agriculture, Office of (3) Enhance the quality, utility and Office of Management and Budget, Information and Regulatory Affairs, clarity of the information to be Washington, DC 20503. Office of Management and Budget, collected; and FOR FURTHER INFORMATON CONTACT: Washington, DC 20503. Copies of the (4) Minimize the burden of the Cindy Pawlikowski, Senior Loan information collection may be requested collection of information on those who Officer, (202) 720–0900. by contacting Lesa A. Johnson at the are to respond, including through the SUPPLEMENTARY INFORMATION: Title: above ADDRESSES. use of appropriate automated, Servicing Minor Program Loans. FOR FURTHER INFORMATION CONTACT: Lesa electronic, mechanical, or other OMB Control Number: 0560–0230. A. Johnson, Agricultural Foreign technological collection techniques or Expiration Date: March 31, 2013. Investment Disclosure Act (AFIDA) other forms of information technology. Type of Request: Extension. Program Manager, (202) 720–9223. All comments received in response to Abstract: Section 331(b) of the SUPPLEMENTARY INFORMATION: this notice, including names and Consolidated Farm and Rural

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Development Act (CONTACT, 7 U.S.C. matter of public record. Comments will to bring related matters to the attention 1981(b)), in part, authorizes the be summarized and included in the of the Committee may file written Secretary of Agriculture to modify, submission for the Office of statements with the Committee staff subordinate and release terms of Management and Budget approval. before or after the meeting. security instruments, leases, contracts, Signed on October 2, 2012. Dated: October 30, 2012. and agreements entered into by FSA. Juan M. Garcia, Carol A. Goularte, That section also authorizes transfers of Administrator, Farm Service Agency. Designated Federal Officer. security property, as the Secretary deems necessary, to carry out the [FR Doc. 2012–27395 Filed 11–8–12; 8:45 am] [FR Doc. 2012–27272 Filed 11–8–12; 8:45 am] purpose of the loan or protect the BILLING CODE 3410–05–P BILLING CODE 3410–11–M Government’s financial interest. Section 335 of the CONACT (7 U.S.C. 1985), DEPARTMENT OF AGRICULTURE DEPARTMENT OF AGRICULTURE provides servicing authority for real estate security; operation or lease of Forest Service National Institute of Food and realty; disposition of property; Agriculture conveyance of real property interest of Sitka Resource Advisory Committee the United States; easements; and RIN 0524–AA43 condemnations. The information AGENCY: Forest Service, USDA. Solicitation of Input From Stakeholders collection relates to a program benefit ACTION: Notice of meeting. Regarding the Veterinary Medicine recipient or loan borrower requesting SUMMARY: The Sitka Resource Advisory Loan Repayment Program (VMLRP) action on security they own, which was Committee will meet in Sitka, Alaska. purchased with FSA loan funds, The committee is meeting as authorized AGENCY: National Institute of Food and improved with FSA loan funds or has under the Secure Rural Schools and Agriculture, USDA. otherwise been mortgaged to FSA to Community Self-Determination Act ACTION: Notice of request for stakeholder secure a Government loan. The (Pub. L. 110–343) and in compliance input. information collected is primarily with the Federal Advisory Committee financial data not already on file, such SUMMARY: The National Institute of Food Act. The purpose of this meeting, is to as borrower asset values, current and Agriculture (NIFA) is soliciting nominate a new Chairman, revise financial information and public use stakeholder input on the administration charter and discuss monitoring of and employment data. of the Veterinary Medicine Loan Estimate of Annual Burden: Public projects. Repayment Program (VMLRP) reporting burden for this collection of DATES: The meetings will be held on authorized under section 1415A of the information is estimated to average .63 November 20, 2012, and will begin at National Agricultural Research, hours per response. 4:00 p.m. Extension, and Teaching Policy Act of Respondents: Individuals, ADDRESSES: The meeting will be held at 1977 (7 U.S.C. 3151a). The purpose of associations, partnerships, or the Forest Service Building, Katlian this program is for the U.S. Department corporations. Conference Room, 204 Siginaka Way, of Agriculture (USDA) to enter into Estimated Number of Respondents: Sitka, Alaska. Written comments should agreements with veterinarians under 58. be sent to Lisa Hirsch, Sitka Ranger which the veterinarians agree to Estimated Number of Responses per District, 204 Siginaka Way, Sitka, provide, for a specific period of time as Respondent: 1. Alaska 99835. Comments may also be identified in the agreement, veterinary Estimated Total Annual Burden on sent via email to [email protected], or services in veterinarian shortage Respondents: 37 hours. via facsimile to 907–747–4253. situations. As part of the stakeholder We are requesting comments on all All comments, including names and input process, NIFA is inviting aspects of this information collection to addresses when provided, are placed in comments regarding the current help us to: the record and are available for public procedures and processes in place for (1) Determine whether the continued inspection and copying. The public may the VMLRP. Input collected will be used collection of information is still inspect comments received at Sitka to modify and improve processes for necessary for the proper performance of Ranger District, 204 Siginaka Way, subsequent calls of shortage situation the functions of the FSA, including Sitka, Alaska. Visitors are encouraged to nominations and request for whether the information will have call ahead to 907–747–4214 to facilitate applications. practical utility; entry into the building. (2) Assess the accuracy of the FSA’s DATES: Written comments are invited estimate of burden including the FOR FURTHER INFORMATION CONTACT: Lisa from interested individuals and validity of the methodology and Hirsch, RAC coordinator, USDA, organizations. All comments must be assumptions used; Tongass NF, Sitka Ranger District, 204 received by close of business on (3) Enhance the quality, utility and Siginaka Way, Sitka, Alaska 99835; 907– December 10, 2012, to be considered. clarity of the information to be 747–4214; Email [email protected]. ADDRESSES: You may submit comments, collected; and SUPPLEMENTARY INFORMATION: The identified by NIFA–2013–0001, by any (4) Minimize the burden of the meeting is open to the public. The of the following methods: collection of information on those who following business will be conducted: Federal eRulemaking Portal: http:// are to respond, including through the (1) Introductions of all committee www.regulations.gov. Follow the use of appropriate automated, members, replacement members and instructions for submitting comments. electronic, mechanical, or other Forest Service personnel. (2) Selection Email: [email protected]. Include technological collection techniques or of a chairperson by the committee NIFA–2013–0001 in the subject line of other forms of information technology. members. (3) Receive materials the message. All comments received in response to explaining the process for considering Fax: 202–720–6486. this notice, including names and and recommending Title II projects; and Mail: Paper, disk or CD–ROM addresses when provided, will be a (4) Public Comment. Persons who wish submissions should be submitted to

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VMLRP, Policy and Oversight Division, services in veterinarian shortage tuition expenses; other reasonable National Institute of Food and situations. educational expenses, including fees, Agriculture, U.S. Department of On October 1, 2009, CSREES became books, and laboratory expenses, Agriculture; STOP 2299, 1400 the NIFA as mandated by the Food, incurred by the individual; and Independence Avenue SW., Conservation, and Energy Act of 2008, reasonable living expenses as Washington, DC 20250–2299. section 7511(f). Accordingly, the determined by the Secretary. In Hand Delivery/Courier: VMLRP; authority to administer the VMLRP addition, the Secretary is directed to Policy and Oversight Division, National transferred from CSREES to NIFA. make such additional payments to Institute of Food and Agriculture, U.S. In FY 2010, VMLRP announced its participants as the Secretary determines Department of Agriculture, Room 2308, first funding opportunity and received appropriate for the purpose of providing Waterfront Centre, 800 9th Street SW., 257 applications from which NIFA reimbursements to participants for Washington, DC 20024. issued 53 VMLRP awards totaling individual tax liability resulting from Instructions: All submissions received $5,185,970. In FY 2011, VMLRP opened participation in this program. The must include the agency name and its second funding opportunity and Secretary delegated the authority to NIFA–2013–0001. All comments received 159 applications from which carry out this program to NIFA. received will be posted without change NIFA issued 75 VMLRP awards totaling NIFA is inviting stakeholder to http://www.regulations.gov, including $7,250,970. In FY 2012, VMLRP opened comments to use in improving the any personal information provided. its third annual application cycle and administration of the VMLRP. Written FOR FURTHER INFORMATION CONTACT: received 139 applications from which comments and suggestions on issues Matthew Lockhart, Senior Policy 47 VMLRP award offers totaling may be submitted to the NIFA Docket Specialist; National Institute of Food $4,644,000 have been made. Each award Clerk at the address above. and Agriculture; U.S. Department of offer is contingent upon submission of a signed contract, thereby executing the Done in Washington, DC, this 26th day of Agriculture; STOP 2299; 1400 October 2012. Independence Avenue SW.; service agreement between the veterinarian and NIFA. Funding for Sonny Ramaswamy, Washington, DC 20250–2299; Voice: Director, National Institute of Food and (202) 559–5088; Email: future years is based on annual appropriations and balances, if any, Agriculture. [email protected]. remaining from prior years. [FR Doc. 2012–27396 Filed 11–8–12; 8:45 am] SUPPLEMENTARY INFORMATION: Section 7105 of the FCEA amended BILLING CODE 3410–22–P Background and Purpose section 1415A to revise the determination of veterinarian shortage The VMLRP helps qualified situations to consider (1) geographical DEPARTMENT OF COMMERCE veterinarians offset a significant portion areas that the Secretary determines have of the debt incurred in pursuit of their a shortage of veterinarians; and (2) areas Bureau of the Census veterinary medicine degrees in return of veterinary practice that the Secretary [Docket Number 121010535–2575–01] for their service in certain high-priority determines have a shortage of veterinary shortage situations. NIFA veterinarians, such as food animal Annual Wholesale Trade Survey will enter into educational loan medicine, public health, epidemiology, repayment agreements with and food safety. This section also added AGENCY: Bureau of the Census, veterinarians who agree to provide that priority should be given to Department of Commerce. veterinary services in veterinarian agreements with veterinarians for the ACTION: Notice of determination. shortage situations for a determined practice of food animal medicine in period of time. NIFA may repay up to veterinarian shortage situations. SUMMARY: The United States Department $25,000 of a veterinarian’s student loan NARETPA section 1415A requires the of Commerce’s Bureau of the Census debt per year if the veterinarian Secretary, when determining the (Census Bureau) publishes this notice to commits to at least three years to amount of repayment for a year of announce that the Director of the provide veterinary services in a service by a veterinarian, to consider the Census Bureau has determined the need designated veterinary shortage area. ability of USDA to maximize the to conduct the 2012 Annual Wholesale Loan repayment benefits are limited to number of agreements from the amounts Trade Survey (AWTS). The AWTS payments of the principal and interest appropriated and to provide an covers employer firms with on government and commercial loans incentive to serve in veterinary service establishments located in the United received for the attendance at an shortage areas with the greatest need. States and classified in the Wholesale accredited college of veterinary This section also provides that loan Trade sector as defined by the 2007 medicine that result in a degree of repayments may consist of payments of North American Industry Classification Doctor of Veterinary Medicine or the the principal and interest on System (NAICS). Through this survey, equivalent. government and commercial loans the Census Bureau will collect data In December 2003, the National received by the individual for the covering annual sales, e-commerce Veterinary Medical Service Act attendance of the individual at an sales, sales taxes, purchases, total and (NVMSA) was passed into law adding accredited college of veterinary detailed operating expenses, year-end section 1415A to the National medicine resulting in a degree of Doctor inventories held both inside and outside Agricultural Research, Extension, and of Veterinary Medicine or the the United States, commissions, total Teaching Policy Act of 1977 equivalent. This program is not operating revenue, and gross selling (NARETPA). This law established a new authorized to provide repayments for value, for three components of Veterinary Medicine Loan Repayment any government or commercial loans wholesale activity: wholesale Program (7 U.S.C. 3151a) authorizing incurred during the pursuit of another distributors; manufacturers’ sales the Secretary of Agriculture (secretary) degree, such as an associate or bachelor branches and offices; and agents, to carry out a program of entering into degree. Loans eligible for repayment brokers, and electronic markets. These agreements with veterinarians under include educational loans made for one data are collected to provide a sound which they agree to provide veterinary or more of the following: Loans for statistical basis for the formation of

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policy by various government agencies. For the 2012 AWTS, we will request Dated: November 2, 2012. Results will be available for use for a data for wholesale distributors on Thomas L. Mesenbourg, Jr., variety of public and business needs detailed operating expenses that were Acting Director, Bureau of the Census. such as economic and market analysis, previously requested under a separate [FR Doc. 2012–27446 Filed 11–8–12; 8:45 am] company performance, and forecasting supplemental mailing (conducted every BILLING CODE 3510–07–P future demand. The Census Bureau 5 years). The last supplemental mailing conducts the AWTS to provide was conducted for the 2007 AWTS continuing and timely national under OMB No. 0607–0942. While the DEPARTMENT OF COMMERCE statistical data on wholesale trade. The wholesale portion of that program will 2012 AWTS is a separate collection be collapsed into the AWTS, we will International Trade Administration from and is not part of the 2012 continue to only ask the detailed [A–570–932] Economic Census. expense questions to wholesale ADDRESSES: The Census Bureau will distributors every 5 years. Also for the Certain Steel Threaded Rod From the provide report forms to businesses 2012 AWTS, we will request data on People’s Republic of China: Final included in the survey. Additional sales taxes, which is asked as a part of Results and Final Partial Rescission of copies are available upon written the AWTS every 5 to 6 years. The last Antidumping Duty Administrative request to the Director, U.S. Census time we requested sales tax data was for Review; 2010–2011 the 2006 AWTS. Bureau, Washington, DC 20233–0101. AGENCY: Import Administration, Firms were selected for the AWTS FOR FURTHER INFORMATION CONTACT: International Trade Administration, using a stratified random sample based Department of Commerce. Randy Moore, Service Sector Statistics on industry groupings and annual sales SUMMARY: Division, at (301) 763–7231 or by email size. We will provide report forms to the On May 8, 2012, the at [email protected]. firms covered by this survey in February Department of Commerce SUPPLEMENTARY INFORMATION: Sections 2013, and will require their responses (‘‘Department’’) published in the 182, 224, and 225 of Title 13 of the within 50 days after receipt. Firms’ Federal Register the Preliminary Results United States Code (U.S.C.) authorize responses to the AWTS are required by of the second administrative review of the Census Bureau to take surveys that law (Title 13, U.S.C., Sections 182, 224, the antidumping duty order on certain are necessary to produce current data on and 225). steel threaded rod from the People’s Republic of China (‘‘PRC’’) for the the subjects covered by the major The sample of firms selected will censuses. As part of this authorization, period of review (‘‘POR’’) April 1, 2010, provide, with measurable reliability, through March 31, 2011.1 Based upon the Census Bureau conducts the AWTS statistics on annual sales, e-commerce to provide continuing and timely our analysis of the comments and sales, sales taxes, purchases, total and information received, we continue to national statistical data on wholesale detailed operating expenses, year-end trade activity for the period between find that RMB Fasteners Ltd., and IFI & inventories held both inside and outside Morgan Ltd. (collectively ‘‘RMB/IFI economic censuses and, for this year, the Unites States, commissions, total during the economic census. The AWTS Group’’) has sold subject merchandise at operating revenue, and gross selling less than normal value. covers employer firms with value, for 2012. establishments located in the United DATES: Effective Date: November 9, The data collected in this survey will States and classified in the Wholesale 2012. be similar to that collected in the past Trade sector as defined by the 2007 FOR FURTHER INFORMATION CONTACT: Jerry and within the general scope and nature NAICS. The 2012 AWTS will collect Huang, AD/CVD Operations, Office 9, of those inquiries covered in the data for three components of wholesale Import Administration, International economic census. These data are activity: Wholesale distributors; Trade Administration, Department of collected to provide a sound statistical manufacturers’ sales branches and Commerce, 14th Street and Constitution basis for the formation of policy by offices; and agents, brokers, and Avenue NW., Washington, DC 20230; various government agencies. Results electronic markets. For wholesale telephone: 202–482–4047. will be available for use for a variety of distributors, the Census Bureau will public and business needs such as SUPPLEMENTARY INFORMATION: collect data covering sales, sales taxes, economic and market analysis, company e-commerce sales, year-end inventories Background performance, and forecasting future held inside and outside theUnited On May 8, 2012, the Department demand. States, purchases, total and detailed published the Preliminary Results. In operating expenses. For manufacturers’ Notwithstanding any other provision the Preliminary Results, the Department sales branches and offices, the Census of law, no person is required to respond indicated its intent to rescind the review Bureau will collect data covering annual to, nor shall a person be subject to a with respect to Gem-Year Industrial Co., sales, sales taxes, e-commerce sales, penalty for failure to comply with, a Ltd. (‘‘Gem-Year’’) and Haiyan Julong year-end inventories held inside and collection of information subject to the Standard Part Co., Ltd. (‘‘Haiyan outside the United States and total requirements of the Paperwork Julong’’) for lack of shipments.2 operating expenses. For agents, brokers, Reduction Act (PRA) unless that On June 8, 2012, the RMB/IFI Group and electronic markets, the Census collection of information displays a submitted factor usage information that Bureau will collect data covering current valid Office of Management and the Department requested for two commissions, total operating revenue, Budget (OMB) control number. In control numbers that were not produced gross selling value, and total operating accordance with the PRA, 44 U.S.C. during the POR. On June 19, 2012, the expenses. The Census Bureau has 3501–3521, OMB approved the AWTS determined that the conduct of this under OMB control number 0607–0195. 1 See Certain Steel Threaded Rod From the survey is necessary as these data are not Based upon the foregoing, I have People’s Republic of China: Preliminary Results of the Administrative Review, Intent To Rescind, and available publicly on a timely basis from directed that the annual survey be Rescission, in Part, 77 FR 27022 (May 8, 2012) non-governmental or other government conducted for the purpose of collecting (‘‘Preliminary Results’’). sources. these data. 2 See Preliminary Results, 77 FR at 27024.

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RMB/IFI Group submitted additional in any straight length, that have been the United States of subject surrogate value information for the final forged, turned, cold-drawn, cold-rolled, merchandise during the POR and no results. Interested parties were further machine straightened, or otherwise party provided written arguments provided an opportunity to comment on cold-finished, and into which threaded regarding this issue. Thus, in the Preliminary Results. Between July grooves have been applied. Certain steel accordance with 19 CFR 351.213(d)(3), 17 and July 24, 2012, we received case threaded rod subject to the order is and consistent with our practice,11 we and rebuttal briefs from interested currently classifiable in the Harmonized are rescinding this review with respect parties. On August 24, 2012, the Tariff Schedule of the United States to Gem-Year and Haiyan Julong. Department extended the time limit for (‘‘HTSUS’’) at subheadings these final results by 60 days.3 7318.15.5051, 7318.15.5056, Final Results of Review 7318.15.5090, and 7318.15.2095.5 The dumping margins for the POR are Analysis of Comments Received Although the subheadings are provided as follows: All issues raised in the case and for convenience and customs purposes, rebuttal briefs by parties to this review the written product description, Weighted- are addressed in the memorandum average available in Certain Steel Threaded Rod Exporter margin entitled, ‘‘Issues and Decision from the People’s Republic of China: (percent) Memorandum for the Final Results of Notice of Antidumping Duty Order, 74 the Second Administrative Review of FR 17154 (April 14, 2009), remains RMB Fasteners Ltd., and IFI Certain Steel Threaded Rod from the dispositive. & Morgan Ltd. (‘‘RMB/IFI People’s Republic of China’’ (‘‘I&D Group’’) ...... 19.68 Memo’’), which is dated November 5, PRC-Wide Entity PRC-wide Entity ...... 206.00 2012, and hereby adopted by this notice. As noted in the Preliminary Results, A list of the issues that parties raised, upon initiation of the administrative The Department will disclose and to which we respond in the I&D review, we provided an opportunity for calculations performed for these final Memo is attached to this notice as all companies for which the review was results to the parties within five days of Appendix I. The I&D Memo is a public initiated to complete either the separate the date of publication of this notice, in document and is on file electronically rate application or certification.6 The accordance with 19 CFR 351.224(b). via Import Administration’s Department preliminarily determined Assessment Antidumping and Countervailing Duty that New Pole Power Systems Co., Ltd. Centralized Electronic Service System (‘‘New Pole’’) failed to demonstrate Upon issuance of the final results, the (‘‘IA ACCESS’’). IA ACCESS is available eligibility for a separate rate and is thus Department will determine, and U.S. to registered users at http:// properly considered not to be separate Customs and Border Protection (‘‘CBP’’) iaaccess.trade.gov and in the Central from the PRC-wide entity.7 Further, in shall assess, antidumping duties on all Records Unit (‘‘CRU’’), room 7046 of the the Preliminary Results we assigned the appropriate entries. The Department main Department of Commerce PRC-wide entity a rate of 206.00 intends to issue assessment instructions building. In addition, a complete percent, the only rate ever determined to CBP 15 days after the date of version of the I&D Memo can be for the PRC-wide entity in this publication of the final results of accessed directly on the internet at proceeding.8 No party submitted review. For any individually examined http://www.trade.gov/ia/. The signed comments regarding this finding. respondents whose weighted-average I&D Memo and the electronic versions Therefore, for these final results, we dumping margin is above de minimis, of the I&D Memo are identical in continue to assign the PRC-wide entity we calculated importer-specific ad content. a rate of 206.00 percent.9 valorem duty assessment rates based on the ratio of the total amount of Changes Since the Preliminary Results Final Partial Rescission antidumping duty calculated for the The Department has made changes to In the Preliminary Results, the importer’s examined sales to the total the preliminary margin calculation for Department indicated its intent to entered value of those same sales in the RMB/IFI Group. Specifically, we rescind this review with respect to Gem- accordance with 19 CFR 351.212(b)(1).12 relied on factor usage information Year and Haiyan Julong upon We will instruct CBP to assess submitted after the Preliminary Results preliminarily determining that they had antidumping duties on all appropriate for the two control numbers that were no shipments of subject merchandise to entries covered by this review when the not produced during the POR and the United States during the POR.10 importer-specific assessment rate updated the Thai import statistics used Subsequent to the Preliminary Results, calculated in the final results of this to value steel wire rod based on the no information was submitted on the review is above de minimis (i.e., 0.50 specific carbon content reported by the record indicating that they made sales to percent). Where either the respondent’s RMB/IFI Group for its steel wire rod consumption.4 5 As part of these final results, the Department has 11 See, e.g., Certain Tissue Paper Products from modified the language of the scope to reflect the fact the People’s Republic of China: Preliminary Results Scope of the Order that HTSUS subheading 7318.15.5050 has been and Partial Rescission of Antidumping Duty deleted and replaced with subheadings Administrative Review, 73 FR 18497, 18500 (April The merchandise covered by the order 7318.15.5051 and 7318.15.5056. See I&D Memo at 4, 2008) (preliminarily rescinding review because of is steel threaded rod. Steel threaded rod Comment 2. lack of reviewable entries), unchanged in Certain is certain threaded rod, bar, or studs, of 6 See Preliminary Results, 77 FR at 27024. Tissue Paper Products from the People’s Republic carbon quality steel, having a solid, 7 See id. of China: Final Results and Final Rescission, in 8 See, e.g., Certain Steel Threaded Rod from the Part, of Antidumping Duty Administrative Review, circular cross section, of any diameter, People’s Republic of China: Final Determination of 73 FR 58113 (October 6, 2008). Sales at Less Than Fair Value, 74 FR 8907 12 In these final results, the Department applied 3 See Department’s Memorandum, re: ‘‘Certain (February 27, 2009). the assessment rate calculation method adopted in Steel Threaded Rod from the People’s Republic of 9 See Certain Steel Threaded Rod from the Antidumping Proceedings: Calculation of the China: Extension of Deadline for Final Results of People’s Republic of China: Final Determination of Weighted-Average Dumping Margin and Antidumping Duty Administrative Review,’’ dated Sales at Less Than Fair Value, 74 FR 8907, 8910 Assessment Rate in Certain Antidumping August 24, 2012. (February 27, 2009). Proceedings: Final Modification, 77 FR 8101 4 See I&D Memo at Comments 1 and 3. 10 See Preliminary Results, 77 FR at 27024. (February 14, 2012).

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weighted-average dumping margin is of the return/destruction of APO this review are listed in the ‘‘Final zero or de minimis, or an importer- materials or conversion to judicial Results Margins’’ section below. specific assessment rate is zero or de protective order is hereby requested. DATES: Effective Date: November 9, minimis, we will instruct CBP to Failure to comply with the regulations 2012. liquidate the appropriate entries and terms of an APO is a violation FOR FURTHER INFORMATION CONTACT: without regard to antidumping duties. which is subject to sanction. Laurel LaCivita, Brooke Kennedy, or We are issuing and publishing this Cash Deposit Requirements Eugene Degnan, AD/CVD Operations, administrative review and notice in Office 8, Import Administration, The following cash deposit accordance with sections 751(a)(1) and International Trade Administration, requirements will be effective upon 777(i) of the Act. publication of the final results of this U.S. Department of Commerce, 14th Dated: November 5, 2012 administrative review for all shipments Street and Constitution Avenue NW., of the subject merchandise entered, or Paul Piquado, Washington, DC 20230; telephone: (202) withdrawn from warehouse, for Assistant Secretary for Import 482–4243, (202) 482–3818, and (202) consumption on or after the publication Administration. 482–0414, respectively. date, as provided for by section Appendix I Background 751(a)(2)(C) of the Tariff Act of 1930, as Comment 1. Surrogate Country Selection On May 4, 2012, the Department amended, (‘‘the Act’’): (1) For the RMB/ A. Economic Comparability and Significant published its Preliminary Results in the IFI Group, the cash deposit rate will be Producer antidumping duty administrative review the rate established in the final results B. Data Availability of frontseating service valves from the of review (except, if the rate is zero or (1) Surrogate Value for Steel Inputs People’s Republic of China.2 On June 1, de minimis, i.e., less than 0.5 percent, a (2) Surrogate Value for Hydrochloric Acid 2012, Petitioner 3 requested a hearing for zero cash deposit rate will be required (3) Surrogate Financial Ratios issues raised in the case and rebuttal for that company); (2) for previously Comment 2. Correcting the Harmonized briefs.4 On June 1, 2011, DunAn investigated or reviewed PRC and non- Tariff Schedule Numbers Within the Scope submitted its 5th supplemental PRC exporters not listed above that have questionnaire response reporting factors a separate rate, the cash deposit rate will Comment 3. Factors of Production for Control Numbers Not Produced During the POR of production (‘‘FOPs’’) for its continue to be the exporter-specific rate unaffiliated brass tollers.5 published for the most recent period; (3) [FR Doc. 2012–27438 Filed 11–8–12; 8:45 am] BILLING CODE 3510–DS–P On June 11, 2012, Petitioner and for all PRC exporters of subject DunAn submitted publicly available merchandise which have not been surrogate value (‘‘SV’’) data to value found to be entitled to a separate rate, 6 DEPARTMENT OF COMMERCE respondents’ factors of production. On the cash deposit rate will be the PRC- June 21, 2012, DunAn and Sanhua wide rate of 206.00 percent; and (4) for International Trade Administration submitted rebuttal SV comments on the all non-PRC exporters of subject June 11, 2012 submissions.7 We [A–570–933] merchandise which have not received received case briefs from Petitioner and their own rate, the cash deposit rate will DunAn on July 12, 2012,8 and rebuttal be the rate applicable to the PRC Frontseating Service Valves From the People’s Republic of China; 2010–2011 exporters that supplied that non-PRC 2 Antidumping Duty Administrative See id. exporter. The deposit requirements, 3 Parker-Hannifin Corporation (‘‘Parker- when imposed, shall remain in effect Review; Final Results Hannifin’’), Petitioner in the underlying investigation. until further notice. AGENCY: Import Administration, 4 See letter from Parker-Hannifin, ‘‘Frontseating Reimbursement of Duties International Trade Administration, Service Valves from the People’s Republic of Department of Commerce. China,’’ dated June 1, 2012. This notice also serves as a final 5 SUMMARY: On May 4, 2012, the See Letter from DunAn, ‘‘DunAn’s Fifth reminder to importers of their Department published its Preliminary Supplemental Questionnaire Response; Second responsibility under 19 CFR 351.402(f) Administrative Review of the Antidumping Duty Results in the antidumping duty to file a certificate regarding the Order on Frontseating Service Valves from the administrative review of frontseating People’s Republic of China,’’ dated June 1, 2012. reimbursement of antidumping duties service valves from the People’s 6 See Letter from Petitioner, ‘‘Petitioner’s prior to liquidation of the relevant Republic of China.1 The period of Submission of Surrogate Values for Final Results in entries during this POR. Failure to the Second Administrative Review of Certain review (‘‘POR’’) is April 1, 2010, comply with this requirement could Frontseating Service Valves from the People’s through March 31, 2011. We have result in the Department’s presumption Republic of China: Case No. A–570–933,’’ dated determined that neither Zhejiang June 1, 2011; see also, Letter from DunAn, that reimbursement of antidumping DunAn Hetian Metal Co., Ltd. ‘‘DunAn’s Post-Preliminary Surrogate Value duties has occurred and the subsequent Submission: Second Administrative Review of the (‘‘DunAn’’) nor Zhejiang Sanhua Co., assessment of doubled antidumping Antidumping Duty Order on Frontseating Service Ltd. (‘‘Sanhua’’), the only companies duties. Valves from the People’s Republic of China,’’ dated covered by this review, made sales in June 11, 2012. Administrative Protective Orders the United States at prices below normal 7 See letter from DunAn, ‘‘Post-Preliminary value (‘‘NV’’). We invited interested Surrogate Value Rebuttal Submission: Second This notice also serves as a reminder Administrative Review of the Antidumping Duty to parties subject to administrative parties to comment on our Preliminary Order on Frontseating Service Valves from the protective order (‘‘APO’’) of their Results. Based on our analysis of the People’s Republic of China,’’ dated June 21, 2012; see also letter from Sanhua, ‘‘Frontseating Service responsibility concerning the return or comments received, we made changes to our margin calculations for DunAn and Valves from the People’s Republic of China; A–570– destruction of proprietary information 933; Surrogate Value Rebuttal Comments for the disclosed under APO in accordance Sanhua. The final dumping margins for Final Results by Zhejiang Sanhua Co., Ltd.,’’ dated with 19 CFR 351.305, which continues June 21, 2012. 1 See Frontseating Service Valves from the 8 See letter from Parker-Hannifin, ‘‘Frontseating to govern business proprietary People’s Republic of China: Preliminary Results of Service Valves from the People’s Republic of China: information in this segment of the the 2010–2011 Antidumping Duty Administrative Petitioner’s Case Brief,’’ dated July 12, 2012; see proceeding. Timely written notification Review, 77 FR 26489 (May 4, 2012). letter from DunAn, ‘‘Case Brief: Second

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briefs from all parties on July 23, 2012.9 main Department of Commerce Final Results Margin On August 6, 2012, Petitioner withdrew building. In addition, a complete We determine the weighted-average its request for a hearing.10 version of the Issues and Decision dumping margins for the period April 1, On August 17, 2012, the Department Memorandum can be accessed directly 2010, through March 31, 2011, to be: originally extended the deadline for the on the internet at http://www.trade.gov/ final results of review to October 31, ia/. The signed Issues and Decision FRONTSEATING SERVICE VALVES FROM 2012.11 As explained in the Memorandum and the electronic THE PRC memorandum from the Assistant versions of the Issues and Decision Secretary for Import Administration, the Memorandum are identical in content. Department has exercised its discretion Weighted-av- Period of Review Exporter erage margin to toll deadlines for the duration of the (percentage) closure of the Federal Government from The POR is April 1, 2010, through October 29, through October 30, 2012. March 31, 2011. Zhejiang DunAn Hetian Thus, all deadlines in this segment of Metal Co. Ltd ...... 0.00 the proceeding have been extended by Scope of the Order Zhejiang Sanhua Co., Ltd .... 0.00 two days. The revised deadline for the The merchandise covered by this final results of this review is now order is frontseating service valves, Assessment Rates 12 Friday, November 2, 2012. assembled or unassembled, complete or Pursuant to section 751(a)(2)(A) of the Analysis of Comments Received incomplete, and certain parts thereof. Tariff Act of 1930, as Amended (‘‘the Frontseating service valves are classified Act’’) and 19 CFR 351.212(b), the All issues raised in the case and under subheading 8481.80.1095, and Department will determine, and U.S. rebuttal briefs filed by parties in this also have been classified under review are addressed in the Customs and Border Protection (‘‘CBP’’) subheading 8415.90.80.85, of the shall assess, antidumping duties on all Memorandum from Christian Marsh, Harmonized Tariff Schedule of the Deputy Assistant Secretary for appropriate entries of subject United States (‘‘HTSUS’’). It is possible Antidumping and Countervailing Duty merchandise in accordance with the for frontseating service valves to be Operations, to Paul Piquado, Assistant final results of this review. Where the manufactured out of primary materials Secretary for Import Administration, weighted-average margin of dumping for other than copper and brass, in which ‘‘Frontseating Service Valves from the the exporter or producer is determined case they would be classified under People’s Republic of China: Issues and to be zero or de minimis, no assessment HTSUS subheadings 8481.80.3040, Decision Memorandum for the Final rates will be calculated and the 8481.80.3090, or 8481.80.5090. In Results of the 2010–2011 Department will instruct CBP to addition, if unassembled or incomplete Administrative Review (‘‘Issues and liquidate all imports from the exporter frontseating service valves are imported, Decision Memorandum’’),’’ dated or producer without regard to concurrently with, and hereby adopted the various parts or components would antidumping duties. The Department by, this notice. A list of the issues that be classified under HTSUS subheadings intends to issue assessment instructions parties raised and to which we 8481.90.1000, 8481.90.3000, or to CBP 15 days after the date of responded in the Issues and Decision 8481.90.5000. The HTSUS subheadings publication of these final results of Memorandum follows as an appendix to are provided for convenience and review. customs purposes, but the written this notice. The Issues and Decision Cash Deposit Requirements Memorandum is a public document and description of the scope of this order, is on file electronically via Import available in Antidumping Duty Order: The following cash deposit Administration’s Antidumping and Frontseating Service Valves from the requirements will be effective upon Countervailing Duty Centralized People’s Republic of China, 74 FR 19196 publication of the final results of this Electronic Service System (‘‘IA (April 28, 2009), remains dispositive. administrative review for all shipments ACCESS’’). IA ACCESS is available to Changes Since the Preliminary Results of the subject merchandise entered, or registered users at http:// withdrawn from warehouse, for iaaccess.trade.gov and in the Central Based on an analysis of the comments consumption on or after the publication Records Unit (‘‘CRU’’), room 7046 of the received, the Department has made the date, as provided for by section following changes in the margin 751(a)(2)(C) of the Act: (1) For DunAn Administrative Review of the Antidumping Duty calculation. and Sanhua, the cash deposit rate will Order on Frontseating Service Valves from the • We valued the surrogate value for be the rate identified in the Final People’s Republic of China,’’ dated July 12, 2012. brass scrap using the HTS number for Results Margin section, as listed above; 9 See letter from Parker-Hannifin, ‘‘Frontseating brass bar and rod. See Comment 2 of the (2) for previously investigated or Service Valves from the People’s Republic of China: Petitioner’s Rebuttal Brief,’’ dated July 23, 2012; see accompanying Issues and Decision reviewed PRC and non-PRC exporters letter from DunAn, ‘‘Rebuttal Case Brief: Second Memorandum. not listed above that have separate rates, Administrative Review of the Antidumping Duty • The Department recalculated the the cash deposit rate will continue to be Order on Frontseating Service Valves from the the exporter-specific rate published for People’s Republic of China,’’ dated July 23, 2012; surrogate financial ratios using the and, see letter from Sanhua, ‘‘Certain Frontseating financial statements of FVC Philippines, the most recent period; (3) for all PRC Service Valves from the People’s Republic of China; Inc. and Makati Foundry, Inc. See exporters of subject merchandise which A–570–933; Rebuttal Brief of Zhejiang Sanhua Co., Comment 4 of the accompanying Issues have not been found to be entitled to a Ltd.,’’ dated July 23, 2012. and Decision Memorandum. separate rate, the cash deposit rate will 10 See letter from Petitioner, ‘‘Frontseating • Service Valves from the People’s Republic of China: We revised Sanhua’s reported scrap continue to be the PRC-wide rate of Request for Hearing,’’ dated August 6, 2012. adjustment to ensure that the reported 55.62 percent; 13 and (4) for all non-PRC 11 See Extension of the Deadline for Final Results. raw materials account fully for the 12 See Memorandum to the Record from Paul reported weight of each FSV model 13 This rate was established in the final results of Piquado, AS for Import Administration, regarding the original investigation. See Frontseating Service ‘‘Tolling of Administrative Deadlines As a Result of sold. See Comment 7 of the Valves from the People’s Republic of China: Final the Government Closure During the Recent accompanying Issues and Decision Determination of Sales at Less Than Fair Value and Hurricane,’’ dated October 31, 2012. Memorandum. Continued

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exporters of subject merchandise which Models Produced Prior to the POR for with section 751(a) of the Tariff Act of have not received their own rate, the DunAn 1930, as amended (the Act). cash deposit rate will be the rate Comment 7: Sanhua’s Brass Scrap Generation Scope of the Order applicable to the PRC exporter that Is Overstated supplied that non-PRC exporter. The [FR Doc. 2012–27424 Filed 11–8–12; 8:45 am] The products subject to the order are deposit requirements shall remain in BILLING CODE P small diameter seamless carbon and effect until further notice. alloy (other than stainless) steel standard, line, and pressure pipes and Notification to Importers DEPARTMENT OF COMMERCE redraw hollows. The products are This notice also serves as a final typically classified in the Harmonized reminder to importers of their International Trade Administration Tariff Schedule of the United States responsibility under 19 CFR [A–485–805] (HTSUS) at subheadings: 7304.10.10.20, 351.402(f)(2) to file a certificate 7304.10.50.20, 7304.19.10.20, regarding the reimbursement of Certain Small Diameter Carbon and 7304.19.50.20, 7304.31.30.00, antidumping duties prior to liquidation Alloy Seamless Standard, Line and 7304.31.60.50, 7304.39.00.16, of the relevant entries during this Pressure Pipe From Romania: Final 7304.39.00.20, 7304.39.00.24, review period. Failure to comply with Results of Antidumping Duty 7304.39.00.28, 7304.39.00.32, this requirement could result in the Administrative Review; 2010–2011 7304.51.50.05, 7304.51.50.60, Secretary’s presumption that 7304.59.60.00, 7304.59.80.10, AGENCY: Import Administration, reimbursement of the antidumping International Trade Administration, 7304.59.80.15, 7304.59.80.20, and duties occurred and the subsequent Department of Commerce. 7304.59.80.25. Although the HTSUS assessment of double antidumping subheadings are provided for SUMMARY: On August 21, 2012, the duties. convenience and customs purposes, the Department of Commerce published the written product descriptions, available Notification to Interested Parties preliminary results of the administrative in Notice of Amended Final review of the antidumping duty order This notice also serves as a reminder Determination of Sales at Less Than on certain small diameter carbon and to parties subject to administrative Fair Value and Antidumping Duty alloy seamless standard, line and protective orders (‘‘APOs’’) of their Order: Certain Small Diameter Carbon pressure pipe from Romania. The period responsibility concerning the return or and Alloy Seamless Standard, Line and of review is August 1, 2010, through destruction of proprietary information Pressure Pipe From Romania, 65 FR disclosed under the APO in accordance July 31, 2011. We gave interested parties an opportunity to comment on the 48963 (August 10, 2000), remains with 19 CFR 351.305(a)(3), which dispositive. continues to govern business preliminary results, but we received no proprietary information in this segment comments. The final weighted-average Final Results of the Review of the proceeding. Timely written dumping margin for ArcelorMittal We have made no changes to our notification of the return/destruction of Tubular Products Roman S.A. is listed calculations announced in the APO materials or conversion to judicial below in the ‘‘Final Results of the Preliminary Results. As a result of our protective order is hereby requested. Review’’ section of this notice. review, we determine that a weighted- Failure to comply with the regulations DATES: Effective Date: November 9, average dumping margin of 0.00 percent and terms of an APO is a violation 2012. exists for ArcelorMittal Tubular which is subject to sanction. FOR FURTHER INFORMATION CONTACT: Products Roman S.A. for the period Disclosure Thomas Schauer, AD/CVD Operations, August 1, 2010, through July 31, 2011. Office 1, Import Administration, Assessment Rates We will disclose the calculations International Trade Administration, performed within five days of the date U.S. Department of Commerce, 14th In accordance with the Final of publication of this notice to parties in Street and Constitution Avenue NW., Modification, we will instruct U.S. this proceeding in accordance with 19 Washington, DC 20230; telephone (202) Customs and Border Protection (CBP) to CFR 351.224(b). 482–0410. liquidate the entries covered by this We are issuing and publishing the review without regard to antidumping final results and notice in accordance Background duties. See Antidumping Proceedings: with sections 751(a)(1) and 777(i)(1) of On August 21, 2012, the Department Calculation of the Weighted-Average the Act. of Commerce (the Department) Dumping Margin and Assessment Rate Dated: November 2, 2012. published the preliminary results of the in Certain Antidumping Duty Paul Piquado, administrative review of the Proceedings; Final Modification, 77 FR Assistant Secretary for Import antidumping duty order on certain 8101 (February 14, 2012) (Final Administration. small diameter carbon and alloy Modification). seamless standard, line and pressure The Department clarified its Appendix I—Issues for the Final pipe from Romania. See Certain Small ‘‘automatic assessment’’ regulation on Results Diameter Carbon and Alloy Seamless May 6, 2003. This clarification will Comment 1: Surrogate Country Selection Standard, Line and Pressure Pipe From apply to entries of subject merchandise Comment 2: Surrogate Value for Brass Bar Romania: Preliminary Results of during the period of review produced by and Rod Antidumping Duty Administrative AMTP for which it did not know its Comment 3: Surrogate Value for Brass Scrap Review, 77 FR 50465 (August 21, 2012) merchandise was destined for the Comment 4: Financial Ratios United States. In such instances, we will Comment 5: Brokerage and Handling for (Preliminary Results). We invited DunAn interested parties to comment on the instruct CBP to liquidate unreviewed Comment 6: Use of Historical FOPs for Preliminary Results, but we received no entries at the all-others rate if there is no comments. rate for the intermediate company(ies) Final Negative Determination of Critical The Department has conducted this involved in the transaction. For a full Circumstances, 74 FR 10886 (March 13, 2009). administrative review in accordance discussion of this clarification, see

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Antidumping and Countervailing Duty with 19 CFR 351.305(a)(3). Timely SUPPLEMENTARY INFORMATION: Proceedings: Assessment of notification of the destruction of APO Background Antidumping Duties, 68 FR 23954 (May materials or conversion to judicial 6, 2003). protective order is hereby requested. The Department published the The Department intends to issue Failure to comply with the regulations Preliminary Results on May 4, 2012.2 assessment instructions directly to CBP and the terms of an APO is a The period of review (‘‘POR’’) is April 15 days after publication of these final sanctionable violation. 1, 2010, through March 31, 2011.3 In results of review. We are issuing and publishing these accordance with 19 CFR results and this notice in accordance 351.309(c)(1)(ii), we invited parties to Cash Deposit Requirements with sections 751(a)(1) and 777(i)(1) of comment on our Preliminary Results.4 The following deposit requirements the Act. On June 13, 2012, we received case will be effective upon publication of Dated: November 2, 2012. briefs from Cherishmet, DJAC, Jacobi, this notice for all shipments of certain CAC, Bright Future, and Shanxi DMD.5 Paul Piquado, small diameter carbon and alloy On June 22, 2012, we received rebuttal seamless standard, line and pressure Assistant Secretary for Import briefs from Petitioners and Cherishmet.6 pipe from Romania entered, or Administration. withdrawn from warehouse, for [FR Doc. 2012–27439 Filed 11–8–12; 8:45 am] Scope of the Order consumption on or after the date of BILLING CODE 3510–DS–P The merchandise subject to the order publication, as provided by section is certain activated carbon.7 The 751(a)(1) of the Act: (1) The cash deposit products are currently classifiable under DEPARTMENT OF COMMERCE rate for ArcelorMittal Tubular Products the Harmonized Tariff Schedule of the Roman S.A. will be 0.00 percent; (2) for International Trade Administration United States (‘‘HTSUS’’) subheading merchandise exported by manufacturers 3802.10.00. Although the HTSUS or exporters not covered in this review [A–570–904] subheading is provided for convenience but covered in the original less-than- and customs purposes, the written fair-value investigation or previous Certain Activated Carbon From the description of the scope of the order reviews, the cash deposit rate will People’s Republic of China; 2010– remains dispositive.8 2011; Final Results of Antidumping continue to be the company-specific rate Analysis of Comments Received published for the most recent period; (3) Duty Administrative Review All issues raised in the case and if the exporter is not a firm covered in AGENCY: Import Administration, this review, a prior review, or the International Trade Administration, rebuttal briefs by parties are addressed original investigation but the Department of Commerce. in the ‘‘Certain Activated Carbon from the People’s Republic of China: Issues manufacturer is, the cash deposit rate SUMMARY: The Department of Commerce and Decision Memorandum for the will be the rate established for the most (‘‘the Department’’) published its recent period for the manufacturer of Final Results of the Fourth Preliminary Results of the antidumping Antidumping Duty Administrative the merchandise; (4) the cash deposit duty order on certain activated carbon rate for all other manufacturers or Review,’’ dated concurrently with this from the People’s Republic of China notice (‘‘Issues & Decision Memo’’). A exporters will continue to be 13.06 (‘‘PRC’’) on May 4, 2012,1 and we gave percent, the all-others rate established list of the issues which parties raised is interested parties an opportunity to attached to this notice as Appendix I. in Notice of Amended Final comment on the Preliminary Results. Determination of Sales at Less Than The Issues & Decision Memo is a public Based upon our analysis of the document and is on file in the Central Fair Value and Antidumping Duty comments and information received, we Order: Certain Small Diameter Carbon Records Unit (‘‘CRU’’), Room 7046 of made changes to the margin calculations the main Department of Commerce and Alloy Seamless Standard, Line and for these final results and partial Pressure Pipe From Romania, 65 FR building, as well as electronically via rescission of antidumping duty Import Administration’s Antidumping 48963 (August 10, 2000). These cash administrative review. The final deposit requirements shall remain in dumping margins are listed below in the 2 See id. effect until further notice. ‘‘Final Results of the Reviews’’ section 3 See id. at 26497. Notifications of this notice. The period of review 4 See id. at 26506. (‘‘POR’’) is April 1, 2010, through March 5 Beijing Pacific Activated Carbon Products Co., This notice serves as a final reminder 31, 2011. Ltd., Ningxia Guanghua Cherishmet Activated to importers of their responsibility Carbon Co., Ltd., Ningxia Guanghua Activated DATES: Effective Date: November 9, under 19 CFR 351.402(f)(2) to file a Carbon Co., Ltd., (collectively, ‘‘Cherishmet’’); 2012. Datong Juqiang Activated Carbon Co., Ltd. certificate regarding the reimbursement (‘‘DJAC’’); Jacobi Carbons AB and its affiliates, FOR FURTHER INFORMATION CONTACT of antidumping duties prior to : Tianjin Jacobi International Trading Co. Ltd., Jacobi liquidation of the relevant entries Alan Ray, Javier Barrientos, or Emeka Carbons Industry (Tianjin) Co., Ltd., and Jacobi during this review period. Failure to Chukwudebe, AD/CVD Operations, Carbons, Inc. (collectively, ‘‘Jacobi’’); Calgon Carbon Office 9, Import Administration, Corp (‘‘CAC’’); Jilin Bright Future Chemicals Co., comply with this requirement could Ltd. (‘‘Bright Future’’); and Shanxi DMD result in the Secretary’s presumption International Trade Administration, Corporation (‘‘Shanxi DMD’’). that reimbursement of antidumping U.S. Department of Commerce, 14th 6 See Petitioners’ Rebuttal Brief, dated June 22, duties occurred and the subsequent Street and Constitution Avenue NW., 2012 and Cherishmet’s Rebuttal Brief, dated June assessment of doubled antidumping Washington, DC 20230; telephone: (202) 22, 2012. 482–5403, (202) 482–2243, or (202) 482– 7 See Certain Activated Carbon from the People’s duties. Republic of China: Issues and Decision This notice also serves as a reminder 0219, respectively. Memorandum for the Final Results of the Fourth to parties subject to the administrative Antidumping Duty Administrative Review,’’ dated protective order (APO) of their 1 See Certain Activated Carbon From the People’s concurrently with this notice for a complete Republic of China: Preliminary Results of the description of the Scope of the Order. responsibility concerning the Fourth Antidumping Duty Administrative Review, 8 See Notice of Antidumping Duty Order: Certain disposition of proprietary information and Intent To Rescind in Part, 77 FR 26496 (May Activated Carbon from the People’s Republic of disclosed under APO in accordance 4, 2012) (‘‘Preliminary Results’’). China, 72 FR 20988 (April 27, 2007).

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and Countervailing Duty Centralized Municipal Yunguang Activated Carbon kilogram (‘‘USD/kg’’), which we Electronic Service System (‘‘IA Co., Ltd.; Ningxia Mineral; Shanxi calculated using the publicly available ACCESS’’). IA ACCESS is available to Sincere Industrial Co., Ltd.; Shanxi figures of U.S. sales quantities for these registered users at http:// Industry Technology Trading Co., Ltd.; firms, is the best reasonable proxy for iaaccess.trade.gov and in the CRU. In Tangshan Solid; and Tianjin Maijin the weighted-average margin based on addition, a complete version of the Industries Co., Ltd.12 We have not the calculated U.S. sales quantities of Issues & Decision Memo can be accessed received any information since the these respondents.17 directly on the internet at http:// issuance of the Preliminary Results that PRC-Wide Rate and PRC-Wide Entity www.trade.gov/ia/. The signed Issues & provides a basis for reconsideration of Decision Memo and the electronic these determinations. Therefore, the The Department used the PRC-Wide version of the Issues & Decision Memo Department continues to find that the rate of 2.42 USD/kg in the most recently are identical in content. companies listed above meet the criteria completed administrative review of this for a separate rate. antidumping order.18 Because we have Final Partial Rescission Additionally, in the Preliminary not calculated a PRC-Wide rate greater In the Preliminary Results, the Results, we also noted that CBP data than the PRC-Wide rate from previous Department preliminarily rescinded the reviewed by the Department does not reviews in this proceeding and nothing review with respect to Shanxi Dapu show any reviewable entries of subject on the record of the instant review calls International Trade Co., Ltd. (‘‘Dapu’’). merchandise made during the POR by into question the reliability of the PRC- This company reported that it had no the third-country exporter, Adsorbent,13 Wide rate, we find it appropriate to shipments of subject merchandise to the an Indian activated carbon company. continue to apply the PRC-Wide rate of United States during the POR, and our For these final results, we continue to 2.42 USD/kg for the final results.19 examination of shipment data from U.S. find that the CBP data does not show In the Preliminary Results, the Customs and Border Protection (‘‘CBP’’) any reviewable entries of subject Department determined that those confirmed that there were no entries of merchandise made by Adsorbent during companies which did not demonstrate subject merchandise made by this the POR and intend to refer this matter eligibility for a separate rate are company during the POR.9 Subsequent to CBP to investigate whether properly considered part of the PRC- to the Preliminary Results, the Adsorbent’s entries were entered wide entity.20 Since the Preliminary Department did not receive any properly. Results, none of the companies which comments or information indicating that did not file separate rate applications or Dapu made sales of subject merchandise Rate for Non-Selected Companies certifications submitted comments to the United States during the POR. In the Preliminary Results, and regarding these findings. Therefore, we Therefore, pursuant to 19 CFR consistent with the Department’s continue to treat these entities as part of 351.213(d)(3), we are rescinding the practice,14 we assigned the separate rate the PRC-wide entity. administrative review with respect to companies a rate calculated using the Final Results of the Review Dapu. ranged total sales quantities of the individually-reviewed respondents with The dumping margins for the POR are Changes Since the Preliminary Results margins above de minimis from the as follows: Based on a review of the record and public versions of their submissions.15 comments received from interested For the final results, we continue to find 17 See ‘‘Memorandum to the File from Alan Ray, Case Analyst, Office 9, AD/CVD Operations, Re: parties regarding our Preliminary this approach to be consistent with the Calculation of Separate Rate,’’ dated concurrently Results, we have made certain revisions intent of section 735(c)(5)(A) of the Act with this notice. to the margin calculations for Jacobi, and our use of section 735(c)(5)(A) of 18 See Certain Activated Carbon From the DJAC, and Cherishmet. For the reasons the Act as guidance when we establish People’s Republic of China: Final Results and Partial Rescission of Third Antidumping Duty explained in the Issues & Decision the rate for respondents not examined Administrative Review, 76 FR 67142, 67145 Memo at Comment I, we have selected individually in an administrative (October 31, 2011). the Philippines as the primary surrogate review.16 See Decision Memo at 19 See Administrative Review of Certain Frozen country. We have also made other Comment 3. Warmwater Shrimp From the People’s Republic of changes to the margin calculations of Because the calculated net U.S. sales China: Final Results and Partial Rescission of Antidumping Duty Administrative Review, 76 FR 10 Cherishmet, DJAC, and Jacobi. Finally, values for the individually-reviewed 51940, 51942 (August 19, 2011) (where the the Surrogate Values Memo contains the respondents with margins above de Department used the PRC-Wide rate from the further explanation of our changes to minimis are business-proprietary previous review). the surrogate values.11 figures, we find that 1.04 U.S. Dollars/ 20 The PRC-Wide entity includes Hebei Foreign Trade and Advertising Corporation; Jilin Province Separate Rates Bright Future Industry and Commerce Co., Ltd.; and 12 See Preliminary Results at 77 FR 26496. United Manufacturing International (Beijing) Ltd. In our Preliminary Results, we 13 Adsorbent Carbons Pvt. Ltd., (‘‘Adsorbent’’). See Preliminary Results, 77 FR at 26501. determined that the following 14 See Certain Frozen Warmwater Shrimp From 21 In the second administrative review of this companies met the criteria for separate the Socialist Republic of Vietnam: Final Results and order, the Department determined that it would rate status: Bright Future; Datong Final Partial Rescission of Antidumping Duty calculate per-unit assessment and cash deposit rates Administrative Review, 76 FR 56158, 56160 for all future reviews. See Certain Activated Carbon (September 12, 2011) (‘‘Vietnam Shrimp’’); see also From the People’s Republic of China: Final Results 9 See Preliminary Results, 77 FR at 26498. Galvanized Steel Wire From the People’s Republic and Partial Rescission of Second Antidumping Duty 10 See Comments II to VI of the Issues and of China: Preliminary Determination of Sales at Administrative Review, 75 FR 70208, 70210 Decision Memo and the company-specific analysis Less Than Fair Value and Postponement of Final (November 17, 2010). memoranda. Determination, 77 FR 68407, 68415 (November 4, 22 In Activated Carbon AR3, the Department 11 See Memorandum to the File, through Matthew 2011) (‘‘Galvanized Wire LTFV’’). found Jacobi Carbons AB, Tianjin Jacobi Renkey, Acting Program Manager, AC/CVD 15 See Jacobi Section A questionnaire response International Trading Co. Ltd., and Jacobi Carbons Operations, Office 9, from Javier Barrientos, Senior (Public Version) dated September 13, 2011, at Industry (Tianjin) are a single entity and, because Case Analyst, Alan Ray, Senior Case Analyst, and Exhibit 4; see also Guanghua Cherishmet Public there has been no change to this determination Emeka Chukwudebe, Case Analyst, AD/CVD Version of Exhibit SA–1 for the Section A since the first administrative review, we continue Operations, Office 9, Certain Activated Carbon from Response, dated August 19, 2011. to find these companies to be part of a single entity. the People’s Republic of China (‘‘PRC’’): Surrogate 16 See Vietnam Shrimp, 76 FR at 56160; see also Therefore, we will assign this rate to the companies Values for the Final Results,’’ (October 31, 2012). Galvanized Wire LTFV, 77 FR at 68415. in the single entity. See Certain Activated Carbon

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Exporter Margin (dollars per kilogram) 21

Datong Juqiang Activated Carbon Co., Ltd...... 0.00 Jacobi Carbons AB 22 ...... 0.44 Ningxia Guanghua Cherishmet Activated Carbon Co., Ltd.23 ...... 2.11 Datong Municipal Yunguang Activated Carbon Co., Ltd...... 1.04 Jilin Bright Future Chemicals Company, Ltd...... 1.04 Ningxia Mineral and Chemical Limited ...... 1.04 Shanxi DMD Corporation ...... 1.04 Shanxi Sincere Industrial Co., Ltd...... 1.04 Shanxi Industry Technology Trading Co., Ltd...... 1.04 Tangshan Solid Carbon Co., Ltd...... 1.04 Tianjin Maijin Industries Co., Ltd...... 1.04 PRC-Wide Rate 24 ...... 2.42

Assessment Rates Cash Deposit Requirements Notification to Importers Regarding The Reimbursement of Duties Pursuant to section 751(a)(2)(A) of the The following cash deposit Act and 19 CFR 351.212(b), the requirements will be effective upon This notice also serves as a final Department will determine, and CBP publication of the final results of this reminder to importers of their shall assess, antidumping duties on all administrative review for all shipments responsibility under 19 CFR 351.402(f) appropriate entries of subject of the subject merchandise from the PRC to file a certificate regarding the merchandise in accordance with the entered, or withdrawn from warehouse, reimbursement of antidumping duties final results of this review. The for consumption on or after the prior to liquidation of the relevant Department intends to issue appropriate publication date, as provided by section entries during this POR. Failure to assessment instructions directly to CBP 751(a)(2)(C) of the Act: (1) For Jacobi, comply with this requirement could 15 days after publication of the final DJAC, Cherishmet, and the Separate result in the Department’s presumption results of this administrative review. Rate Respondents, the cash deposit rate that reimbursement of antidumping will be their respective rates established duties has occurred and the subsequent For assessment purposes, we in the final results of this review, except assessment of doubled antidumping calculated importer (or customer)- if the rate is zero or de minimis no cash duties. specific assessment rates for deposit will be required; (2) for merchandise subject to this review. As previously investigated or reviewed PRC Administrative Protective Orders the Department stated in the most recent and non-PRC exporters not listed above administrative review,25 we will that have separate rates, the cash This notice also serves as a reminder continue to direct CBP to assess deposit rate will continue to be the to parties subject to administrative importer-specific assessment rates based exporter-specific rate published for the protective orders (‘‘APO’’) of their on the resulting per-unit (i.e., per- most recent period; (3) for all PRC responsibility concerning the return or kilogram) rates by the weight in exporters of subject merchandise which destruction of proprietary information kilograms of each entry of the subject have not been found to be entitled to a disclosed under APO in accordance merchandise during the POR. separate rate, the cash deposit rate will with 19 CFR 351.305, which continues Specifically, we calculated importer- be the PRC-Wide rate of $2.42 per to govern business proprietary specific duty assessment rates on a per- kilogram; and (4) for all non-PRC information in this segment of the unit rate basis by dividing the total exporters of subject merchandise which proceeding. Timely written notification dumping margins (calculated as the have not received their own rate, the of the return or destruction of APO difference between normal value and cash deposit rate will be the rate materials, or conversion to judicial export price or constructed export price) applicable to the PRC exporters that protective order, is hereby requested. for each importer by the total sales supplied that non-PRC exporter. These Failure to comply with the regulations quantity of subject merchandise sold to deposit requirements, when imposed, and terms of an APO is a violation that importer during the POR. If an shall remain in effect until further which is subject to sanction. importer (or customer)-specific notice. We are issuing and publishing this assessment rate is de minimis (i.e., less Disclosure than 0.50 percent), the Department will administrative review and notice in instruct CBP to assess that importer (or We will disclose the calculations accordance with sections 751(a)(1) and customer’s) entries of subject performed within five days of the date 777(i) of the Act. merchandise without regard to of publication of this notice to parties in antidumping duties, in accordance with this proceeding in accordance with 19 19 CFR 351.106(c)(2). CFR 351.224(b).

From the People’s Republic of China: Final Results since the first administrative review, we continue Republic of China: Final Results of Antidumping and Partial Rescission of the Third Antidumping to find these companies to be part of a single entity. Duty Administrative Review, 74 FR 57995, 57996 Duty Administrative Review, 76 FR 67142, 67145 Therefore, we will assign this rate to the companies n.2 (November 10, 2009). n.25 (October 31, 2011) (‘‘Activated Carbon AR3’’). in the single entity. See Certain Activated Carbon 24 As discussed above in this notice, the PRC- 23 In Activated Carbon AR1, the Department From the People’s Republic of China: Notice of Wide entity includes Hebei Foreign Trade and found Beijing Pacific Activated Carbon Products Preliminary Results of the Antidumping Duty Advertising Corporation; Jilin Province Bright Co., Ltd., Ningxia Guanghua Cherishmet Activated Administrative Review and Extension of Time Future Industry and Commerce Co., Ltd.; and Carbon Co., Ltd., and Ningxia Guanghua Activated Limits for the Final Results, 74 FR 21317 (May 7, United Manufacturing International (Beijing) Ltd. Carbon Co., Ltd. are a single entity and, because 2009), unchanged in First Administrative Review of 25 there has been no change to this determination Certain Activated Carbon from the People’s Activated Carbon AR3, 76 FR at 67145.

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Dated: November 2, 2012. Comments received by 5:00 p.m. EST/ proper Amending Motions (Certified Paul Piquado, EDST on November 16, 2012 will be Amending Motions) will be presented for Assistant Secretary for Import considered by the respective NFPA action at the annual June 2014 Association Administration. Committees before final action is taken Technical Meeting. Documents that receive on the comments. no motions will be forwarded directly to the Appendix I—Issues & Decision Standards Council for action on issuance. Memorandum ADDRESSES: The 2013 Fall Revision Cycle First Draft Reports are available For more information on these new General Issues and downloadable from NFPA’s Web rules and for up-to-date information on COMMENT I: SELECTION OF SURROGATE site at http://www/nfpa.org/FDRSDR. schedules and deadlines for processing COUNTRY Comments can be submitted online by NFPA Documents, check the NFPA Web A. Economic Comparability going to link above. site at www.nfpa.org, or contact NFPA B. Significant Producer of the Comparable FOR FURTHER INFORMATION CONTACT: Codes and Standards Administration. Merchandise C. Data Considerations Amy Beasley Cronin, Secretary, The purpose of this notice is to A. Anthracite Coal Standards Council, NFPA, 1 request comments on the First Draft B. Bituminous Coal Batterymarch Park, Quincy, Report for the NFPA’s 2013 Fall C. Carbonized Material Massachusetts 02169–7471, (617) 770– Revision Cycle. The publication of this D. Hydrochloric Acid 3000. David F. Alderman, NIST, 100 notice by the National Institute of E. Labor Bureau Drive, MS 2100, Gaithersburg, Standards and Technology (NIST) on F. Financial Ratios MD 20899, email: behalf of NFPA is being undertaken as COMMENT II: CALCULATION OF THE [email protected] or by phone at a public service; NIST does not SEPARATE RATE 301–975–4019. COMMENT III: MISCELLANEOUS necessarily endorse, approve, or SURROGATE VALUES SUPPLEMENTARY INFORMATION: Since recommend any of the standards A. ELECTRICITY 1896, the National Fire Protection referenced in the notice. B. SALT Association (NFPA) has accomplished C. BUCKLES its mission by advocating consensus Background COMMENT IV: PER-UNIT ASSESSMENT/ codes and standards, research, training, The National Fire Protection DUTY ABSORPTION and education for safety related issues. ® Association (NFPA) develops building, Company-Specific Issues NFPA’s National Fire Codes , which fire, and electrical safety codes and holds over 295 documents, are COMMENT V: VALUATION OF JACOBI’S standards. Federal agencies frequently CONSUMPTION OF BITUMINOUS administered by more than 240 use these codes and standards as the COAL FOR HEATING Technical Committees comprised of basis for developing Federal regulations COMMENT VI: VALUATION OF JACOBI’S approximately 7,600 volunteers and are concerning safety. Often, the Office of CONSUMPTION OF STEAM COAL adopted and used throughout the world. the Federal Register approves the INPUT NFPA is a nonprofit membership incorporation by reference of these COMMENT VII: CALCULATION OF organization with approximately 70,000 standards under 5 U.S.C. 552(a) and 1 FREIGHT FOR CERTAIN PACKING members from over 100 nations, all CFR Part 51. INPUTS working together to fulfill the COMMENT VIII: CALCULATION OF Association’s mission. Request for Comments JACOBI’S TRANSPORT BAGS IN The NFPA process provides ample NORMAL VALUE opportunity for public participation in Interested persons may participate in COMMENT IX: DO NOT USE AN the development of its codes and these revisions by submitting written ADJUSTMENT FOR DIRECT LABOR data, views, or arguments to Amy AND ELECTRICITY FOR CHERISHMET standards. All NFPA codes and standards are revised and updated every Beasley Cronin, Secretary, Standards [FR Doc. 2012–27423 Filed 11–8–12; 8:45 am] three to five years in Revision Cycles Council, NFPA, 1 Batterymarch Park, BILLING CODE 3510–DS–P that begin twice each year and take Quincy, Massachusetts 02169–7471. approximately two years to complete. Commenters may go to the NFPA Web site at http://www.nfpa.org/FDRSDR. DEPARTMENT OF COMMERCE Each Revision Cycle proceeds according to a published schedule that includes Each person submitting a comment should include his or her name and National Institute of Standards and final dates for all major events in the address, identify the notice, and give Technology process. The Code Revision Process contains four basic steps that are reasons for any recommendations. National Fire Codes: Request for followed for developing new documents Comments received by 5:00 p.m. EST/ Comments on NFPA’s Codes and as well as revising existing documents. EDST on November 16, 2012 for the Standards Step 1: Public Input Stage, which results 2013 Fall Revision Cycle First Draft in the First Draft Report (formerly ROP); Reports will be considered by the NFPA AGENCY: National Institute of Standards Step 2: Comment Stage, which results in before final action is taken on the First and Technology, Commerce. the Second Draft Report (formerly ROC); Draft Reports. ACTION: Notice. Step 3: the Association Technical Copies of all written comments SUMMARY: The National Institute of Meeting at the NFPA Conference & received and the disposition of those Standards and Technology (NIST) is Expo; and Step 4: Standards Council comments by the NFPA committees will publishing this notice on behalf of the consideration and issuance of be published as the 2013 Fall Revision National Fire Protection Association documents. Cycle Second Draft Reports and will be (NFPA) to announce the availability of Note: Anyone wishing to make Amending available on the NFPA Web site at and request comments on the technical Motions on the Second Draft Reports http://www.nfpa.org/FDRSDR. reports that will be reporting in the (formerly ROP and ROC) must signal his or 2013 Fall Revision Cycle NFPA’s 2013 Fall Revision Cycle. her intention by submitting a Notice of Intent to Make a Motion by the Deadline of 5:00 First Draft Reports DATES: Sixteen First Draft Reports are p.m. EST/EDST on or before August 23, 2013. published on the NFPA Web site at Certified motions will be posted by October (P = Partial revision; W = Withdrawal; http://www.nfpa.org/FDRSDR. 18, 2013. Documents that receive notice of N = New)

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NFPA 37 ...... Standard for the Installation and Use of Stationary Combustion Engines and Gas Turbines ...... P NFPA 69 ...... Standard on Explosion Prevention Systems ...... P NFPA 82 ...... Standard on Incinerators and Waste and Linen Handling Systems and Equipment ...... P NFPA 730 ...... Guide for Premises Security ...... P NFPA 731 ...... Standard for the Installation of Electronic Premises Security Systems ...... P NFPA 750 ...... Standard on Water Mist Fire Protection Systems ...... P NFPA 921 ...... Guide for Fire and Explosion Investigations ...... P NFPA 1005 ...... Standard for Professional Qualifications for Marine Fire Fighting for Land-Based Fire Fighters ...... P NFPA 1192 ...... Standard on Recreational Vehicles ...... P NFPA 1194 ...... Standard for Recreational Vehicle Parks and Campgrounds ...... P NFPA 1521 ...... Standard for Fire Department Safety Officer ...... P NFPA 1561 ...... Standard on Emergency Services Incident Management System ...... P NFPA 1670 ...... Standard on Operations and Training for Technical Search and Rescue Incidents ...... P NFPA 1963 ...... Standard for Fire Hose Connections ...... P NFPA 1965 ...... Standard for Fire Hose Appliances ...... P NFPA 1975 ...... Standard on Station/Work Uniforms for Emergency Services ...... P

Dated: November 5, 2012. Southeast Region, NMFS, 263 13th measure, photograph, weigh, and Willie E. May, Avenue South, Saint Petersburg, FL sample tissue. Sea turtles would then be Associate Director for Laboratory Programs. 33701; phone (727) 824–5312; fax released within four hours of capture. [FR Doc. 2012–27470 Filed 11–8–12; 8:45 am] (727) 824–5309. Sea turtles might be unintentionally re- BILLING CODE 3510–13–P Written comments on this application captured within a year. should be submitted to the Chief, Dated: November 5, 2012. Permits and Conservation Division P. Michael Payne, • By email to DEPARTMENT OF COMMERCE Chief, Permits and Conservation Division, [email protected] (include Office of Protected Resources, National National Oceanic and Atmospheric the File No. in the subject line of the Marine Fisheries Service. Administration email), • By facsimile to (301) 713–0376, or [FR Doc. 2012–27343 Filed 11–8–12; 8:45 am] RIN 0648–XC325 • At the address listed above. BILLING CODE 3510–22–P Those individuals requesting a public Endangered Species; File No. 15809 hearing should submit a written request DEPARTMENT OF COMMERCE AGENCY: National Marine Fisheries to the Chief, Permits and Conservation Service (NMFS), National Oceanic and Division at the address listed above. The National Oceanic and Atmospheric Atmospheric Administration (NOAA), request should set forth the specific Administration Commerce. reasons why a hearing on this application would be appropriate. ACTION: Notice; receipt of application. RIN 0648–XC338 FOR FURTHER INFORMATION CONTACT: SUMMARY: Notice is hereby given that Kristy Beard or Amy Hapeman, (301) Fisheries of the South Atlantic; Paul Jobsis, Ph.D., University of the 427–8401. Southeast Data, Assessment and Virgin Islands, Department of Biology, 2 SUPPLEMENTARY INFORMATION: The Review (SEDAR); Public Meeting John Brewers Bay, St Thomas, VI 00802, subject permit is requested under the AGENCY: National Marine Fisheries has applied in due form for a permit to authority of the Endangered Species Act Service (NMFS), National Oceanic and take green (Chelonia mydas) and of 1973, as amended (ESA; 16 U.S.C. Atmospheric Administration (NOAA), hawksbill (Eretmochelys imbricata) sea 1531 et seq.) and the regulations Commerce. turtles for the purpose of scientific governing the taking, importing, and research. exporting of endangered and threatened ACTION: Notice of SEDAR 30 Assessment species (50 CFR parts 222–226). Process Webinar I for Caribbean blue DATES: Written, telefaxed, or email The applicant requests a 5-year permit tang and queen triggerfish. comments must be received on or before to conduct research on green and December 10, 2012. hawksbill sea turtles around protected SUMMARY: The SEDAR 30 assessments of ADDRESSES: The application and related bays of St. Thomas and St. John, U.S. the Caribbean blue tang and queen documents are available for review by Virgin Islands. The purpose of the triggerfish will consist of a series of selecting ‘‘Records Open for Public research is to assess the ecological workshops and webinars. This notice is Comment’’ from the Features box on the movements of juvenile green and for a webinar associated with the Applications and Permits for Protected hawksbill sea turtles. Researchers would Assessment portion of the SEDAR Species (APPS) home page, https:// directly capture up to 40 adult, process. See SUPPLEMENTARY apps.nmfs.noaa.gov, and then selecting subadult, or juvenile green sea turtles INFORMATION. File No. 15809 from the list of available using tangle nets and up to 40 juvenile DATES: The SEDAR 30 Assessment applications. and subadult hawksbill sea turtles by Webinar I will be held November 29, These documents are also available hand or using dip nets each year. No 2012 from 10 a.m. until approximately upon written request or by appointment more than 40 total sea turtles (both 12 p.m. Eastern Time (ET). The in the following offices: species combined) would be captured in established times may be adjusted as Permits and Conservation Division, a year. The following procedures would necessary to accommodate the timely Office of Protected Resources, NMFS, be conducted on sea turtles: Count/ completion of discussion relevant to the 1315 East-West Highway, Room survey, attach flipper and passive assessment process. Such adjustments 13705, Silver Spring, MD 20910; integrated transponder tags, attach may result in the meeting being phone (301) 427–8401; fax (301) 713– acoustic transmitters using epoxy or a extended from, or completed prior to, 0376; and combination of wire and epoxy, the time established by this notice.

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ADDRESSES: The meeting will be held completed since the Assessment proposals for alternatives to be via webinar. The webinar is open to Workshop. considered in the 2012 Steller Sea Lion members of the public. Those interested Although non-emergency issues not Protection Measures EIS currently being in participating should contact Julie A. contained in this agenda may come prepared by NMFS. The SSLMC will Neer at SEDAR (see FOR FURTHER before this group for discussion, those begin drafting one or more alternatives INFORMATION CONTACT) to request an issues may not be the subject of formal for recommendation to the Council in invitation providing webinar access action during this meeting. Action will December, 2012. Proposals under information. be restricted to those issues specifically consideration will be posted on the FOR FURTHER INFORMATION CONTACT: Julie listed in this notice and any issues Council’s Web site at http:// A. Neer, SEDAR Coordinator, 4055 arising after publication of this notice www.alaskafisheries.noaa.gov/npfmc/ Faber Place, Suite 201, North that require emergency action under conservation-issues/ssl.html. Please Charleston, SC 29405; telephone: (843) section 305(c) of the Magnuson-Stevens note that State or Federal ID will be 571–4366; email: [email protected]. Fishery Conservation and Management required to enter the Federal Building in Act, provided the public has been SUPPLEMENTARY INFORMATION: The Gulf Juneau. Foreign nationals wishing to notified of the Council’s intent to take of Mexico, South Atlantic, and attend this meeting in person should final action to address the emergency. Caribbean Fishery Management contact the Council as soon as possible Councils, in conjunction with NOAA Special Accommodations to expedite security clearance at the Fisheries and the Atlantic and Gulf Federal Building in Juneau. The meeting is physically accessible Additional information is posted on States Marine Fisheries Commissions, to people with disabilities. Requests for have implemented the Southeast Data, the Council Web site: http:// sign language interpretation or other www.alaskafisheries.noaa.gov/npfmc/. Assessment and Review (SEDAR) auxiliary aids should be directed to the The meeting will be webcast to allow process, a multi-step method for Council office (see ADDRESSES) at least the public to watch and hear determining the status of fish stocks in 10 business days prior to the meeting. the Southeast Region. SEDAR is a three- presentations. Comments will not be step process including: (1) Data Dated: November 6, 2012. accepted via webcast or teleconference. Workshop; (2) Assessment Process Tracey L. Thompson, Although non-emergency issues not utilizing webinars and workshops; and Acting Deputy Director, Office of Sustainable contained in this agenda may come (3) Review Workshop. The product of Fisheries, National Marine Fisheries Service. before this group for discussion, those the Data Workshop is a data report [FR Doc. 2012–27375 Filed 11–8–12; 8:45 am] issues may not be the subject of formal which compiles and evaluates potential BILLING CODE 3510–22–P action during this meeting. Action will datasets and recommends which be restricted to those issues specifically datasets are appropriate for assessment listed in this notice and any issues analyses. The product of the Assessment DEPARTMENT OF COMMERCE arising after publication of this notice Process is a stock assessment report that require emergency action under National Oceanic and Atmospheric which describes the fisheries, evaluates section 305(c) of the Magnuson-Stevens Administration the status of the stock, estimates Fishery Conservation and Management biological benchmarks, projects future RIN 0648–XC339 Act, provided the public has been population conditions, and recommends notified of the Council’s intent to take research and monitoring needs. The North Pacific Fishery Management final action to address the emergency. assessment is independently peer Council; Public Meeting reviewed at the Review Workshop. The Special Accommodations AGENCY: National Marine Fisheries product of the Review Workshop is a Service (NMFS), National Oceanic and The meeting is physically accessible summary documenting panel opinions Atmospheric Administration (NOAA), to people with disabilities. Requests for regarding the strengths and weaknesses Commerce. sign language interpretation or other of the stock assessment and input data. auxiliary aids should be directed to Gail ACTION: Notice of a public meeting. Participants for SEDAR Workshops are Bendixen, (907) 271–2809, at least 5 appointed by the Gulf of Mexico, South SUMMARY: The North Pacific Fishery working days prior to the meeting date. Atlantic, and Caribbean Fishery Management Council’s (Council) Steller Dated: November 6, 2012. Management Councils and NOAA Sea Lion Mitigation Committee Fisheries Southeast Regional Office, Tracey L. Thompson, (SSLMC) will meet in Seattle, WA. Acting Deputy Director, Office of Sustainable Highly Migratory Species (HMS) DATES: The meeting will be held Management Division, and Southeast Fisheries, National Marine Fisheries Service. November 28–29, 2012, from 8:30 a.m. [FR Doc. 2012–27376 Filed 11–8–12; 8:45 am] Fisheries Science Center. Participants through 5 p.m. AST. include: Data collectors and database BILLING CODE 3510–22–P ADDRESSES: managers; stock assessment scientists, The meeting will be held at biologists, and researchers; constituency the Alaska Fishery Science Center, 7600 DEPARTMENT OF COMMERCE representatives including fishermen, Sand Point Way NE., Seattle, environmentalists, and non- Washington. Council address: North Pacific National Telecommunications and governmental organizations (NGOs); Fishery Management Council, 605 W. Information Administration international experts; and staff of 4th Ave., Suite 306, Anchorage, AK Councils, Commissions, and state and 99501–2252. First Responder Network Authority federal agencies. Board Meeting FOR FURTHER INFORMATION CONTACT: SEDAR 30 Assessment Webinar I Steve MacLean, North Pacific Fishery AGENCY: National Telecommunications Participants of the webinar will have Management Council; telephone: (907) and Information Administration, U.S. an opportunity to review and comment 271–2809. Department of Commerce. on the draft assessment report and any SUPPLEMENTARY INFORMATION: At this ACTION: Notice of open public meetings. additional assessment modeling work meeting, the SSLMC will be reviewing

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SUMMARY: The National meetings is subject to change. Please SUMMARY: The Committee is proposing Telecommunications and Information refer to NTIA’s Web site at http://www. to add a product and services to the Administration (NTIA) will convene ntia.doc.gov/category/firstnet for the Procurement List that will be furnished open public meetings of the Board of the most current information. by nonprofit agencies employing First Responder Network Authority Other Information: The meeting is persons who are blind or have other (FirstNet). open to the public and press. Given the severe disabilities. DATES: The meetings will be held on space limitations of the Secretary’s Comments Must Be Received on or December 11, 2012; April 23, 2013; Conference Room where the Board will Before: 12/10/2012. August 13, 2013; and October 15, 2013, meet, members of the public wishing to attend the meeting in person will be ADDRESSES: Committee for Purchase from 9 a.m. to 12:30 p.m. Eastern Time From People Who Are Blind or Severely in Washington, DC.1 directed to the Auditorium in the Herbert C. Hoover Building where they Disabled, Jefferson Plaza 2, Suite 10800, ADDRESSES: For the meetings in can observe the meeting by video. Due 1421 Jefferson Davis Highway, Washington, DC, Board members will to security requirements and to facilitate Arlington, Virginia 22202–3259. meet in the Secretary’s Conference entry into the building, U.S. nationals For Further Information or to Submit Room, Room 5855, Herbert C. Hoover must present valid, government-issued Comments Contact: Patricia Briscoe, Building, U.S. Department of photo identification upon arrival. Telephone: (703) 603–7740, Fax: (703) Commerce, 14th Street and Constitution Foreign nationals must contact Uzoma 603–0655, or email Avenue NW., Washington, DC. Onyeije at (202) 482–0016 or uonyeije@ [email protected]. FOR FURTHER INFORMATION CONTACT: ntia.doc.gov at least five (5) business Uzoma Onyeije, Senior Advisor for SUPPLEMENTARY INFORMATION: This days prior to the meeting in order to notice is published pursuant to 41 Public Safety, National provide the necessary clearance Telecommunications and Information U.S.C. 8503(a)(2) and 41 CFR 51–2.3. Its information, and must present valid, purpose is to provide interested persons Administration, U.S. Department of government-issued photo identification Commerce, 1401 Constitution Avenue an opportunity to submit comments on upon arrival. the proposed actions. NW., Washington, DC 20230; telephone The meetings are accessible to people (202) 482–0016; email uonyeije@ntia. with disabilities. Individuals requiring Additions doc.gov. Please direct media inquiries to accommodations, such as sign language NTIA’s Office of Public Affairs, (202) If the Committee approves the interpretation or other ancillary aids, are proposed additions, the entities of the 482–7002. asked to notify Uzoma Onyeije, Senior SUPPLEMENTARY INFORMATION: Federal Government identified in this Advisor for Public Safety, at (202) 482– notice will be required to procure the Background: The Middle Class Tax 0016 or [email protected] at least Relief and Job Creation Act of 2012 product and services listed below from five (5) business days before the nonprofit agencies employing persons (Act), Public Law 112–96, 126 Stat. 156 meeting. (2012), created FirstNet as an who are blind or have other severe The meetings will also be webcast. disabilities. independent authority within NTIA. Please refer to NTIA’s Web site at The following product and services The Act directs FirstNet to establish a http://www.ntia.doc.gov/category/ are proposed for addition to the single nationwide, interoperable public firstnet for webcast instructions and Procurement List for production by the safety broadband network. The FirstNet other information. If you have technical nonprofit agencies listed: Board is responsible for making strategic questions regarding the webcast, please decisions regarding FirstNet’s contact Charles Franz at cfranz@ntia. Product operations. The FirstNet Board held its doc.gov. Access details for these first public meeting on September 25, meetings are subject to change. Please NSN: 5180–01–435–3502—Tool Kit, Multipurpose Plier 2012. refer to NTIA’s Web site at http://www. Matters To Be Considered: NTIA will NPA: The Lighthouse for the Blind, St. Louis, ntia.doc.gov/category/firstnet for the MO post a detailed agenda on its Web site, most current information. Contracting Activity: General Services http://www.ntia.doc.gov/category/ Records: NTIA maintains records of Administration, Tools Acquisition firstnet prior to each meeting. The all Board proceedings. Board minutes Division I, Kansas City, Mo. agenda topics are subject to change. will be available at http://www.ntia.doc. Coverage: B-List for the Broad Government Time and Date: The meetings will be gov/category/firstnet. Requirement as aggregated by the held on December 11, 2012; April 23, General Services Administration. Dated: November 6, 2012. 2013; August 13, 2013; and October 15, Services 2013, from 9 a.m. to 12:30 p.m. Eastern Kathy D. Smith, Time. The times are subject to change. Chief Counsel. Service Type/Location: Custodial and [FR Doc. 2012–27435 Filed 11–8–12; 8:45 am] Grounds Maintenance Services, Rocky Please refer to NTIA’s Web site at Mountain Metropolitan Airport (RMMA), http://www.ntia.doc.gov/category/ BILLING CODE 3510–60–P Air Traffic Control Tower (ATCT) & Base firstnet for the most current information. Building, 11001 Control Tower Drive, Place: The meetings will be held in Westminster, CO. the Secretary’s Conference Room, Room COMMITTEE FOR PURCHASE FROM NPA: AspenPointe Employment, Colorado 5855, U.S. Department of Commerce, PEOPLE WHO ARE BLIND OR Springs, CO. Herbert C. Hoover Building, 14th Street SEVERELY DISABLED Contracting Activity: Dept of Transportation, and Constitution Avenue NW., Federal Aviation Administration, Washington, DC. The location of these Procurement List; Proposed Additions Renton, WA Service Type/Location: Mess Attendant AGENCY: Committee for Purchase From 1 Services and Cook Support, Eielson AFB, Additional meetings will be held February 12, People Who Are Blind or Severely AK. 2013, and December 17, 2013 in Boulder, Colorado; and June 11, 2012, in San Francisco, California. Disabled. NPA: Lakeview Center, Inc., Pensacola, FL. NTIA will publish separate Federal Register ACTION: Proposed Additions to the Contracting Activity: Department of the Air Notices for the Boulder and San Francisco Procurement List. Force (5700)/Eielson Air Force Base (FA meetings. 5004), Eielson AFB, AK.

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The information is provided to further CORPORATION FOR NATIONAL AND • Evaluate whether the proposed describe the Mess Attendant Services COMMUNITY SERVICE collection of information is necessary and Cook Support being proposed for for the proper performance of the addition to the Procurement List. For Proposed Information Collection; functions of CNCS, including whether this project, the DOD contracting Comment Request the information will have practical activity identified its requirement as utility; AGENCY: Corporation for National and • Evaluate the accuracy of the Mess Attendants Service and Cook Community Service. Support. The Mess Attendant and Cook agency’s estimate of the burden of the ACTION: Notice. proposed collection of information, Support tasks are: (1) Serving and including the validity of the replenishing food; (2) Cleaning SUMMARY: The Corporation for National methodology and assumptions used; facilities, equipment, pots, pans, and and Community Service (CNCS), as part • Enhance the quality, utility, and utensils; (3) Cleaning tables in the of its continuing effort to reduce clarity of the information to be Dining Area; (4) Preparing vegetables paperwork and respondent burden, collected; and and fruits for the salad bar and to be conducts a pre-clearance consultation • Minimize the burden of the cooked; (5) Preparing hot and cold program to provide the general public collection of information on those who sandwiches; (6) Providing cashier and federal agencies with an are expected to respond, including the services; (7) Maintaining quality control; opportunity to comment on proposed use of appropriate automated, and (8) Providing maintenance and and/or continuing collections of electronic, mechanical, or other housekeeping services for the facility. information in accordance with the technological collection techniques or Paperwork Reduction Act of 1995 (PRA) other forms of information technology Patricia Briscoe, (44 U.S.C. 3506(c)(2)(A)). This program (e.g., permitting electronic submissions Deputy Director, Business Operations, helps to ensure that requested data can of responses). (Pricing and Information Management). be provided in the desired format, Background [FR Doc. 2012–27374 Filed 11–8–12; 8:45 am] reporting burden (time and financial BILLING CODE 6353–01–P resources) is minimized, and the impact The Serve America Act requires CNCS of the requirement on respondents can grantees and subgrantees to conduct a be properly assessed. National Service Criminal History Currently, CNCS is soliciting Check. CNCS and its grantees must CONSUMER PRODUCT SAFETY comments concerning its proposed ensure that national service COMMISSION recordkeeping requirement in 45 CFR beneficiaries are protected from harm 2540.205–.206. CNCS grantees and and the recordkeeping requirements of Sunshine Act Meeting Notice subgrantees must maintain records to the final rule are critical to that demonstrate completion of National responsibility. Service Criminal History Checks. TIME AND DATE: Wednesday, November Current Action 14, 2012, 10:00 a.m.–12:00 p.m. DATES: Written comments must be submitted to the individual and office CNCS requests renewal of the PLACE: Room 420, Bethesda Towers, listed in the ADDRESSES section by recordkeeping requirement previously 4330 East West Highway, Bethesda, January 8, 2013. approved under an emergency clearance. Maryland. ADDRESSES: You may submit comments, The requirements will be used in the STATUS: Commission Meeting—Open to identified by the title of the information same manner as the existing the Public. collection activity, by any of the application. CNCS also seeks to following methods: continue using the current application MATTERS TO BE CONSIDERED: (1) By mail sent to: Corporation for until the revised application is National and Community Service, Briefing Matters: approved by OMB. The current Aaron Olszewski, Office of General 1. Bedside Sleepers—Notice of application is due to expire on March Counsel; 1201 New York Avenue NW., Proposed Rulemaking; 31, 2013. Washington, DC 20525. Type of Review: Renewal of Approved 2. Handheld Carriers—Notice of (2) By hand delivery or by courier to Proposed Rulemaking. Recordkeeping Requirement. the CNCS mailroom at Room 8100 at the Agency: Corporation for National and A live webcast of the Meeting can be mail address given in paragraph (1) Community Service. viewed at www.cpsc.gov/webcast. above, between 9:00 a.m. and 4:00 p.m. Title: National Service Criminal Eastern Time, Monday through Friday, For a recorded message containing the History Check Recordkeeping except Federal holidays. latest agenda information, call (301) Requirement. (3) By fax to: (202) 606–3467, 504–7948. OMB Number: 3045–0145. Attention: Paperwork Reduction Act. Agency Number: None. CONTACT PERSON FOR MORE INFORMATION: (4) Electronically, through Affected Public: CNCS Grantees and Todd A. Stevenson, Office of the www.regulations.gov. Individuals who Subgrantees. Secretary, U.S. Consumer Product use a telecommunications device for the Total Respondents: 112,357. Safety Commission, 4330 East West deaf (TTY–TDD) may call 1–800–833– Frequency: Three times per covered Highway, Bethesda, MD 20814, (301) 3722 between 8:00 a.m. and 8:00 p.m. position. Average Time per Response: Five 504–7923. Eastern Time, Monday through Friday. FOR FURTHER INFORMATION CONTACT: minutes. Dated: November 6, 2012. Estimated Total Burden Hours: 28,089 Aaron Olszewski, (202) 606–6709, or by hours. Todd A. Stevenson, email at [email protected]. Secretary. Total Burden Cost (capital/startup): SUPPLEMENTARY INFORMATION: CNCS is None. [FR Doc. 2012–27486 Filed 11–7–12; 11:15 am] particularly interested in comments Total Burden Cost (operating/ BILLING CODE 6355–01–P that: maintenance): None.

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Comments submitted in response to www.ClearwaterProgram.org. submitted by postal mail or delivery this notice will be summarized and/or Alternatively, printed copies are should be addressed to the Director of included in the request for Office of available at the following locations: the Information Collection Clearance Management and Budget approval; they Sanitation Districts of Los Angeles Division, U.S. Department of Education, will also become a matter of public County, 1955 Workman Mill Road, 400 Maryland Avenue SW., LBJ, Room record. Whittier, California; Carson Regional 2E117, Washington, DC 20202–4537. Dated: November 5, 2012. Library, 151 East Carson Street, Carson, FOR FURTHER INFORMATION CONTACT: Valerie Green, California; Los Angeles Public Library, Electronically mail San Pedro Branch, 931 South Gaffey [email protected]. Please do not General Counsel. Street, San Pedro, California; and Los send comments here. [FR Doc. 2012–27349 Filed 11–8–12; 8:45 am] Angeles Public Library, Wilmington SUPPLEMENTARY INFORMATION: The BILLING CODE 6050–$$–P Branch, 1300 North Avalon Boulevard., Department of Education (ED), in Wilmington, California. Written accordance with the Paperwork comments will be accepted until the Reduction Act of 1995 (PRA) (44 U.S.C. DEPARTMENT OF DEFENSE close of public review on December 10, 3506(c)(2)(A)), provides the general 2012. public and Federal agencies with an Final Environmental Impact Statement/ For Additional Information Contact: opportunity to comment on proposed, Environmental Impact Report (EIS/EIR) Questions or comments concerning the revised, and continuing collections of for the Clearwater Program Final EIS/EIR should be directed to Dr. information. This helps the Department AGENCY: U.S. Army Corps of Engineers, Aaron O. Allen, U.S. Army Corps of assess the impact of its information Department of the Army. Engineers, Los Angeles District, collection requirements and minimize Regulatory Division, Ventura Field the public’s reporting burden. It also ACTION: Notice of availability. Office, 2151 Alessandro Drive, Suite helps the public understand the SUMMARY: The U.S. Army Corps of 110, Ventura, CA 93001, (805) 585– Department’s information collection Engineers (Corps) in conjunction with 2148. requirements and provide the requested the Sanitation Districts of Los Angeles Dated: October 29, 2012. data in the desired format. ED is County (Sanitation Districts) has David J. Castanon, soliciting comments on the proposed information collection request (ICR) that completed a Final Environmental Chief, Regulatory Division, Corps of Impact Statement/Environmental Engineers. is described below. The Department of Impact Report (EIS/EIR) for the Education is especially interested in [FR Doc. 2012–27448 Filed 11–8–12; 8:45 am] public comment addressing the Clearwater Program. The Clearwater BILLING CODE 3720–58–P Program is a comprehensive planning following issues: (1) Is this collection effort undertaken by the Sanitation necessary to the proper functions of the Districts for the Joint Outfall System, a Department; (2) will this information be DEPARTMENT OF EDUCATION regional wastewater management processed and used in a timely manner; system serving approximately 4.8 [Docket No.: ED–2012–ICCD–0050] (3) is the estimate of burden accurate; million people in 73 cities and (4) how might the Department enhance unincorporated areas in Los Angeles Agency Information Collection the quality, utility, and clarity of the County. A major component of the Activities; Submission to the Office of information to be collected; and (5) how Clearwater Program is the evaluation of Management and Budget for Review might the Department minimize the alternatives for construction of a new and Approval; Comment Request; burden of this collection on the ocean outfall and rehabilitation of the 2013–2014 Federal Student Aid respondents, including through the use existing ocean outfalls. Both activities Application of information technology. Please note would entail discharge of dredged and that written comments received in AGENCY: Department of Education (ED), fill material in waters of the United response to this notice will be Federal Student Aid (FSA). States, work in navigable waters of the considered public records. United States, and the transport of ACTION: Notice. Title of Collection: 2013–2014 Federal dredged material for ocean disposal. Student Aid Application. SUMMARY: In accordance with the OMB Control Number: 1845–0001. These activities would require Paperwork Reduction of 1995 (44 U.S.C. Type of Review: Revision of an authorization from the Corps pursuant chapter 3501 et seq.), ED is proposing a existing information collection. to Section 404 of the Clean Water Act, revision of an existing information Respondents/Affected Public: Section 10 of the Rivers and Harbors collection. Individuals or households. Act, and Section 103 of the Marine Total Estimated Number of Annual DATES: Protection, Research, and Sanctuaries Interested persons are invited to Responses: 46,099,008. Act, respectively. The Draft EIS/EIR was submit comments on or before Total Estimated Number of Annual circulated for a 57-day review period December 10, 2012. Burden Hours: 25,959,853. from February 13, 2012 through April ADDRESSES: Comments submitted in Abstract: Section 483 of the Higher 10, 2012. The Corps and the Sanitation response to this notice should be Education Act of 1965, as amended Districts reviewed and provided submitted electronically through the (HEA), mandates that the Secretary of responses to 19 agency comments and Federal eRulemaking Portal at http:// Education ‘‘* * *shall produce, 33 public comments in preparing the www.regulations.gov by selecting distribute, and process free of charge Final EIS/EIR. Docket ID number ED–2012–ICCD–0050 common financial reporting forms as The Final EIS/EIR, including a Draft or via postal mail, commercial delivery, described in this subsection to be used 404(b)(1) alternatives analysis, is or hand delivery. Please note that for application and reapplication to available for a 31-day review period comments submitted by fax or email determine the need and eligibility of a from November 9, 2012 through and those submitted after the comment student for financial assistance* * *’’. December 10, 2012. The document is period will not be accepted. Written The determination of need and accessible via the World-Wide Web at requests for information or comments eligibility are for the following Title IV,

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HEA, federal student financial Federal Student Aid, an office of the of the data they submitted on the assistance programs: The Federal Pell U.S. Department of Education (hereafter FAFSA. The applicant reviews the SAR, Grant Program; the Campus-Based ‘‘the Department’’), subsequently and, if necessary, will make corrections programs (Federal Supplemental developed an application process to or updates to their submitted FAFSA. collect and process the data necessary to Educational Opportunity Grant The Department seeks OMB approval determine a student’s eligibility to (FSEOG), Federal Work-Study (FWS), of all application components as a receive Title IV, HEA program and the Federal Perkins Loan Program); single ‘‘collection of information’’. The the William D. Ford Federal Direct Loan assistance. The application process involves an applicant’s submission of aggregate burden will be accounted for Program; the Teacher Education under OMB Control Number 1845–0001. Assistance for College and Higher the Free Application for Federal Student Aid (FAFSA). After submission of the The specific application components, Education (TEACH) Grant; and the Iraq FAFSA, an applicant receives a Student descriptions and submission methods and Afghanistan Service Grant. Aid Report (SAR), which is a summary for each are listed in Table 1.

TABLE 1—FEDERAL STUDENT AID APPLICATION COMPONENTS

Component Description Submission method

Initial Submission of FAFSA

FAFSA on the Web (FOTW) .... Online FAFSA that offers applicants a customized experience...... Submitted by the applicant via www.fafsa.gov. FOTW—Renewal ...... Online FAFSA for applicants who have previously completed the FAFSA. FOTW—EZ ...... Online FAFSA for applicants who qualify for the Simplified Needs Test (SNT) or Automatic Zero (Auto Zero) needs analysis formulas. FOTW—EZ Renewal ...... Online FAFSA for applicants who have previously completed the FAFSA and who qualify for the SNT or Auto Zero needs analysis formulas. FAFSA on the Phone (FOTP) .. The Federal Student Aid Information Center (FSAIC) representatives assist ap- Submitted through plicants by filing the FAFSA on their behalf through FOTW. www.fafsa.gov for appli- cants who call 1–800–4– FED–AID. FOTP—EZ ...... FSAIC representatives assist applicants who qualify for the SNT or Auto Zero needs analysis formulas by filing the FAFSA on their behalf through FOTW. FAA Access ...... Online tool that a financial aid administrator (FAA) utilizes to submit a FAFSA Submitted through www.faaacess.ed.gov by a FAA on behalf of an appli- cant. FAA Access—Renewal ...... Online tool that a FAA can utilize to submit a Renewal FAFSA.. FAA Access—EZ ...... Online tool that a FAA can utilize to submit a FAFSA for applicants who qualify for the SNT or Auto Zero needs analysis formulas. FAA Access—EZ Renewal ...... Online tool that a FAA can utilize to submit a FAFSA for applicants who have previously completed the FAFSA and who qualify for the SNT or Auto Zero needs analysis formulas. Electronic Other ...... This is a submission done by a FAA, on behalf of the applicant, using the The FAA may be using their Electronic Data Exchange (EDE). mainframe computer or software to facilitate the EDE process. PDF FAFSA or Paper FAFSA The paper version of the FAFSA printed by the Department for applicants who Mailed by the applicant. are unable to access the Internet or the online PDF FAFSA for applicants who can access the Internet but are unable to complete the form using FOTW.

Correcting Submitted FAFSA Information and Reviewing FAFSA Information

FOTW—Corrections ...... Any applicant who has a Federal Student Aid PIN (FSA PIN)—regardless of Submitted by the applicant how they originally applied—may make corrections using FOTW Corrections. via www.fafsa.gov. Electronic Other—Corrections With the applicant’s permission, corrections can be made by a FAA using the The FAA may be using their EDE. mainframe computer or software to facilitate the EDE process. Paper SAR—This is a SAR The full paper summary that is mailed to paper applicants who did not provide Mailed by the applicant. and an option for corrections. an e-mail address and to applicants whose records were rejected due to crit- ical errors during processing. Applicants can write corrections directly on the paper SAR and mail for processing. FAA Access—Corrections ...... An institution can use FAA Access to correct the FAFSA ...... Submitted through www.faaacess.ed.gov by a FAA on behalf of an appli- cant. Internal Department Correc- The Department will submit an applicant’s record for system-generated correc- There is no burden to the ap- tions. tions. plicants under this correc- tion type as these are sys- tem-based corrections. FSAIC Corrections ...... Any applicant, with their Data Release Number (DRN), can change the post- These changes are made di- secondary institutions listed on their FAFSA or change their address by call- rectly in the CPS system ing FSAIC. by a FSAIC representative.

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TABLE 1—FEDERAL STUDENT AID APPLICATION COMPONENTS—Continued

Component Description Submission method

SAR Electronic (eSAR) ...... The eSAR is an online version of the SAR that is available on FOTW to all ap- Cannot be submitted for plicants with a PIN. Notifications for the eSAR are sent to students who ap- processing. plied electronically or by paper and provided an e-mail address. These notifi- cations are sent by e-mail and include a secure hyperlink that takes the user to the FOTW site. SAR Acknowledgment ...... This is the condensed paper SAR that is mailed to applicants who applied electronically but did not provide an e-mail address and do not meet the cri- teria for a full paper SAR.

This information collection also application cycle. The total application hours (67 minutes), reducing their documents an estimate of the annual projection for 2013–2014 is based upon burden by .18 hours (11 minutes). public burden as it relates to the two factors—estimates of the total Corrections are also projected to application process for federal student enrollment in all degree-granting decrease by 760,696 responses for 2013– aid. The Applicant Burden Model institutions and the percentage change 14. Fewer corrections mean that more (ABM), measures applicant burden in FAFSA submissions for the last comprehensive and accurate data was through an assessment of the activities completed or almost completed captured in the initial submission of the each applicant conducts in conjunction application cycle. The ABM is also application. Updated completion times with other applicant characteristics and based on the application options were calculated for each component and in terms of burden, the average available to students and parents. The have been used to estimate the burden, applicant’s experience. Key Department accounts for each excluding the change in the applicant determinants of the ABM include: application component based on web volume. The results demonstrate that D The total number of applicants that trending tools, survey information, and the burden for all applicants would will potentially apply for federal other Department data sources. have decreased by almost 13 percent or student aid; For 2013–2014, the Department is 3,758,702 hours, if the application D How the applicant chooses to reporting a net burden reduction of volume had remained constant. complete and submit the FAFSA (e.g., 3,398,000 hours. The reduction is a If the Department had not simplified by paper or electronically via FOTW); reflection of the effects of simplifying the application process, thus reducing D How the applicant chooses to FAFSA on the Web, which is utilized by the time required to complete the submit any corrections and/or updates the majority of applicants who apply for FAFSA, the new burden estimates (e.g., the paper SAR or electronically via aid. Simplification of the application is would only need to account for the FOTW Corrections); demonstrated by (1) the average change in applicants. The 1.43% D The type of SAR document the completion times for initial submissions increase in applicants would result in applicant receives (eSAR, SAR and; (2) fewer corrections being made to an increase in burden of 347,945 hours. acknowledgment, or paper SAR); the application. Accounting for both the increase in D The formula applied to determine The projected average completion total applicants and the decrease in the applicant’s expected family times for initial submissions has individual applicant burden, the net contribution (EFC) (full need analysis decreased by 11 minutes for 2013–14. In change is an overall decrease of almost formula, Simplified Needs Test or data reported in the 2012–2013 12 percent or 3,398,000 hours. The Automatic Zero); and supporting statement, first-time filers following Table shows the net burden D The average amount of time using FOTW would take approximately change and total cost for applicants. The involved in preparing to complete the 1.30 hours (78 minutes) to submit an change in total annual responses is also application. application. The data from 2011–12 listed in the Table. Total annual The ABM is largely driven by the indicate that the same user would be responses include the original FAFSA number of potential applicants for the able to submit their application in 1.12 submission and corrections.

TABLE 2—NET BURDEN CHANGE

2012–2013 2013–2014 Change % Change Burden disposition

Accounting for change in applicant burden and change in applicants.

Total Applicants ...... 24,705,864 25,053,809 +347,945 +1.41 Net decrease in burden. Total Applicant Burden ...... 29,357,853 25,959,853 ¥3,398,000 ¥11.6 The 1.41% increase in applicants is offset by the results of the simplification changes implemented by the Depart- ment. This has resulted in an overall de- crease in burden of 11.57% or 3,397,545 hours. Total Annual Responses ...... 46,447,024 46,099,007 ¥348,017 ¥.75 Cost for All Applicants ...... $234,804.24 $190,224.76 $44,579.48 ¥18.99

The Department takes pride in the decrease in burden associated with the year. The results confirm the significant continued efforts to simplify the FAFSA application process, even as the improvements that have been made to submission process and the continued Department serves more students each the application process. The Department

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believes that these changes will lead to Alternative Dispute Resolution Center, management reports, statistical analysis, more students completing the FAFSA Office of Management, U.S. Department and case status reports. and will assist more students with their of Education, Capitol Place Building, 80 The ADR Center Case Tracking pursuit of postsecondary education F Street NW., Room 408C/Mail Stop System will be a standalone system of through access to Title IV, HEA program 4000, Washington, DC 20001–1528. If records that will no longer be located in assistance. you prefer to send comments through the OM, Office of Hearings and Appeals, but instead will be located in the OM, Dated: November 5, 2012. the Internet, use the following address: [email protected]. Alternative Dispute Resolution Center. Darrin A. King, These records will be maintained, not Director, Information Collection Clearance You must include the term ‘‘ADR Center System of Records’’ in the only in paper files in filing cabinets, but Division, Privacy, Information and Records will now also be maintained Management Services, Office of Management. subject line of your electronic message. During and after the comment period, electronically on a computerized [FR Doc. 2012–27449 Filed 11–8–12; 8:45 am] tracking system, as well as in an email BILLING CODE 4000–01–P you may inspect all public comments about this notice at the U.S. Department system. They will now be maintained of Education in room 410–F, 80 F Street electronically to improve efficiency and functionality, particularly with regard to DEPARTMENT OF EDUCATION NW., Room 410C/Mail Stop 4000, Washington, DC 20001–1528, between tracking. The ADR Center Case Tracking Privacy Act of 1974; System of the hours of 8:00 a.m. and 4:30 p.m., System will collect the same data as Records—Alternative Dispute Eastern time, Monday through Friday of previously collected on current and Resolution (ADR) Center Case each week except Federal holidays. former non-bargaining unit employees Tracking System of the Department and applicants. Assistance to Individuals With The Department published the AGENCY: Office of Management (OM), Disabilities in Reviewing the original system of records on June 4, Alternative Dispute Resolution Center, Rulemaking Record 1999, in the Federal Register. (64 FR 30106, 30137–30139). This notice adds Department of Education. On request we will provide an the category of individuals whose ACTION: Notice of altered systems of appropriate accommodation or auxiliary records are maintained to include records. aid to an individual with a disability current and former bargaining-unit who needs assistance to review the SUMMARY: In accordance with the employees of the Department. It also comments or other documents in the Privacy Act of 1974, as amended, 5 revises the purpose for which the public rulemaking record for this notice. U.S.C. 552a (Privacy Act), the information is used in the system of If you want to schedule an appointment Department of Education (Department) records to indicate that it will be used: for this type of accommodation or publishes this notice proposing to revise (1) To track, manage, and report on all auxiliary aid, please contact the person the system of records entitled data, events, and procedures related to listed under FOR FURTHER INFORMATION ‘‘Grievances Filed Informally Through pre-grievances (administrative or CONTACT. the Informal Dispute Resolution Center’’ negotiated); (2) to track, manage, and (IDR Center) (18–05–12), including FOR FURTHER INFORMATION CONTACT: report on all data, events, and revising the title to ‘‘Alternative Dispute Debra A. Bennett, Director, Alternative procedures related to pre-Equal EEO Resolution (ADR) Center Case Tracking Dispute Resolution Center, Office of complaints referred to the ADR Center System.’’ Management, U.S. Department of for alternative dispute resolution; (3) to DATES: Submit your comments on this Education, Capitol Place Building, 80 F track, manage, and report on all data, proposed altered system of records on or Street NW., Room 408C/Mail Stop 4000, events, and procedures related to formal before December 10, 2012. Washington, DC 20001–1528. EEO complaints referred to the ADR The Department has filed a report Telephone number: 202–401–0693. If Center for alternative dispute resolution; describing the altered system of records you use a telecommunications device (4) to track, manage, and report on all covered by this notice with the Chair of for the deaf (TDD), or text telephone data, events, and procedures related to the Senate Committee on Homeland (TTY), you may call the Federal Relay Department employees filing any Security and Governmental Affairs, the Service (FRS), toll free, at 1–800–877– workplace issue; (5) to collect, analyze, Chair of the House Committee on 8339. and report data pertinent to the Oversight and Government Reform, and particular claim being asserted to SUPPLEMENTARY INFORMATION: include some Personally Identifiable the Administrator of the Office of Information (PII) for periodic reports Information and Regulatory Affairs, Introduction and analysis; (6) to maintain a record of Office of Management and Budget The ADR Center Case Tracking the data provided by employees (OMB) on November 6, 2012. This System is a web-based J2EE application requesting assistance; (7) to act as a altered system of records will become that is platform independent and source for information necessary to effective on the later date of: (1) The captures all information relating to fulfill OM, Equal Employment expiration of the 40-day period for OMB Alternative Dispute Resolution case Opportunity Services’ alternative review on December 17, 2012, unless processing. It tracks, manages, and dispute resolution reporting OMB waives 10 days of the 40-day reports on all data, events, and requirements; and (8) to enable review period for compelling reasons procedures related to pre-grievances complaint resolution partners to review shown by the Department; or (2) (administrative and negotiated), pre- and analyze the data of their formal December 10, 2012, unless the systems Equal Employment Opportunity (EEO) grievance/complaint population. In of records needs to be changed as a complaints, formal EEO complaints, and addition, the authority for maintenance result of public comment or OMB other workplace issues. The ADR Center of the ADR Center Case Tracking system review. Case Tracking System provides a of records has been updated to include ADDRESSES: Address all comments about reporting module that collects data for applicable sources of authority. the ADR Center Case Tracking system of tracking, managing, and reporting In addition, the Department proposes records to Debra A. Bennett, Director, purposes, including, but not limited to, to revise the routine uses. We propose

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to revise routine use (3)(a)(iii) system), the safeguards that protect the have Adobe Acrobat Reader, which is ‘‘Litigation and Alternative Dispute records in the system, and updates the available free at the site. Resolution (ADR) Disclosures’’ to permit system manager and address. The You may also access documents of the the Department to disclose certain retention and disposal policy has been Department published in the Federal records from this system to the parties updated to comply with the General Register by using the article search described in routine use paragraphs Records Schedule approved by the feature at: www.federalregister.gov. (3)(b) ’’Disclosure to the Department of National Archives and Records Specifically, through the advanced Justice (DOJ),’’ (3)(c) ‘‘Administrative Administration. The description of search feature at this site, you can limit Disclosures,’’ and (3)(d) ‘‘Parties, safeguards has been updated to include your search to documents published by Counsel, Representatives, and additional security measures that have the Department. Witnesses’’ for any Department been put in place, including monitoring Dated: November 6, 2012. employee in his or her individual by security personnel and the testing of Winona H. Varnon, capacity if the DOJ has been requested the system’s security posture. to provide or arrange for representation Principal Deputy Assistant Secretary for The Privacy Act requires the Management, Delegated the Authority to of the employee. Department to publish in the Federal Perform the Functions and Duties of the The Department proposes to also Register this notice of an altered system Assistant Secretary for Management. revise routine use (6) ‘‘Labor of records (5 U.S.C. 552a(e)(4) and (11)). For the reasons discussed in the Organization Disclosure’’ to permit the The Department’s regulations introduction, the Principal Deputy Department to disclose records from this implementing the Privacy Act are Assistant Secretary for Management, system to an arbitrator to resolve contained in part 5b of title 34 of the U.S. Department of Education disputes under a negotiated grievance Code of Federal Regulations (CFR). (Department) publishes a notice of procedure or to officials of labor The Privacy Act applies to any record altered system of records to read as organizations recognized under 5 U.S.C. about an individual containing follows: chapter 71 when relevant and necessary individually identifying information to their duties of exclusive that is retrieved from a system of SYSTEM NUMBER: 18–05–12 representation. In addition, the records by a unique identifier associated SYSTEM NAME: Department also proposes to revise with each individual, such as a name or routine use (7) ‘‘Freedom of Information Alternative Dispute Resolution (ADR) social security number. The information Center Case Tracking System Act (FOIA) and Privacy Act Advice about each individual is called a Disclosure’’ to permit the Department to ‘‘record,’’ and the system, whether SECURITY CLASSIFICATION: disclose records from this system to the manual or computer-based, is called a Department of Justice and OMB if the None. ‘‘system of records.’’ Department concludes that disclosure is The Privacy Act requires each agency SYSTEM LOCATION: desirable or necessary in determining to publish notices of systems of records Alternative Dispute Resolution whether particular records are required in the Federal Register and to prepare Center, Office of Management, U.S. to be disclosed under the FOIA or the reports to OMB and Congress whenever Department of Education, Capitol Place Privacy Act. Building, 80 F Street, NW., Room 408C/ Finally, the Department proposes to the agency publishes a new system of records or makes a significant change to Mail Stop 4000, Washington, DC 20001– add a new, routine use (13) ‘‘Disclosure 1528. in the Course of Responding to a Breach an established system of records. of Data’’ to permit the Department to Each agency is also required to send CATEGORIES OF INDIVIDUALS COVERED BY THE disclose records from this system to copies of the report to the Chair of the SYSTEM: appropriate agencies, entities, and Senate Committee on Homeland This system contains records about persons when: (a) The Department Security and Governmental Affairs and current and former Department suspects or has confirmed that the the Chair of the House Committee on employees or applicants who have security or confidentiality of Oversight and Government Reform. contacted the ADR Center within 45 information in the system of records has These reports are included to permit an calendar days of becoming aware of an been compromised; (b) the Department evaluation of the probable effect of the incident or work-related dispute has determined that as a result for the proposal on the privacy rights of needing resolution. A work-related suspected or confirmed compromise individuals. dispute can include a pre-grievance there is a risk of harm to economic or Accessible Format: Individuals with (administrative or negotiated), pre-Equal property interests, identity theft or disabilities can obtain this document in Employment Opportunity (EEO) fraud, or harm to the security or an accessible format (e.g., braille, large complaint, or formal EEO complaint integrity of this system or other systems print, audiotape, or compact disc) on that involves various labor and or programs (whether maintained by the request to the contact person listed in employment laws and regulations Department or another agency or entity) this section. pertaining to informal workplace that rely upon the compromised Electronic Access to This Document: dispute resolution. information; and (c) the disclosure made The official version of this document is to such agencies, entities, and persons is the document published in the Federal CATEGORIES OF RECORDS IN THE SYSTEM: reasonably necessary to assist in Register. Free Internet access to the This system of records produces an connection with the Department’s official edition of the Federal Register Alternative Dispute Resolution Center efforts to respond to the suspected or and the Code of Federal Regulations is case file that contains personally confirmed compromise and prevent, available via the Federal Digital System identifying information that is pertinent minimize, or remedy such harm. at: www.gpo.gov/fdsys. At this site you to the particular claim (e.g., non- The notice also revises the policies can view this document, as well as all selection, disciplinary action, and practices for storing, retrieving, other documents of the Department performance problem) being asserted, accessing, retaining, and disposing of published in the Federal Register, in including, but not limited to, documents records in the system (particularly the text or Adobe Portable Document that contain the employee’s name, sex, retention and disposal of records in the Format (PDF). To use PDF you must date of birth, home address, and

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telephone number. This system of and analyze the data of their formal Department has agreed to represent the records does not include records grievance/complaint population. employee; or covered by the Department’s system of (v) The United States where the ROUTINE USES OF RECORDS MAINTAINED IN THE records notices entitled ‘‘Discrimination Department determines that the SYSTEM, INCLUDING CATEGORIES OF USERS AND litigation is likely to affect the Complaints Records System’’ 18–05–04 THE PURPOSES OF SUCH USES: or the Equal Employment Opportunity Department or any of its components. The Department may disclose Commission (EEOC)/GOVT-1 System of (b) Disclosure to the DOJ. If the information contained in a record in Records Notice entitled ‘‘Equal Department determines that disclosure this system of records under the routine Employment Opportunity in the Federal of certain records to the DOJ is relevant uses listed in the system of records Government Complaint and Appeal and necessary to litigation or ADR, the without the consent of the individual, if Records’’ and ‘‘Grievances Filed Department may disclose those records the disclosure is compatible with the Formally Under the Administrative as a routine use to the DOJ. purposes for which the record was Grievance Procedure’’ 18–05–05’’ or (c) Adjudicative Disclosures. If the collected. These disclosures may be ‘‘Grievance Records Filed Under Department determines that disclosure made on a case-by-case basis or, if the Procedures Established by Labor of certain records to an adjudicative Department has complied with the Management Negotiations’’ 18–05–06. body before which the Department is computer matching requirements of the authorized to appear, an individual or AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Privacy Act of 1974, as amended entity designated by the Department or (Privacy Act), under a computer otherwise empowered to resolve or The system is authorized under the matching agreement. mediate disputes is relevant and Administrative Dispute Resolution Act (1) Disclosure for Use by Other Law necessary to the litigation or ADR, the of 1996 (ADRA), 5 U.S.C. 571 et seq.; Enforcement Agencies. The Department Department may disclose those records Age Discrimination in Employment Act may disclose information to any as a routine use to the adjudicative of 1967, as amended (ADEA), 29 U.S.C. Federal, State, local, or foreign agency body, individual, or entity. 621 et seq.; EEOC regulations, 29 CFR or other public authority responsible for (d) Parties, Counsel, Representatives, part 1614; Title VII of the Civil Rights enforcing, investigating, or prosecuting and Witnesses. If the Department Act of 1964, 42 U.S.C. 2000e et seq.; violations of administrative, civil, or determines that disclosure of certain Sections 501 and 505 of the criminal law or regulation if that records to a party, counsel, Rehabilitation Act of 1973, as amended, information is relevant to any representative, or witness is relevant 29 U.S.C. 791 et seq.; the Equal Pay Act, enforcement, regulatory, investigative, and necessary to the litigation or ADR, 29 U.S.C. 206(d); the Genetic or prosecutorial responsibility within the Department may disclose those Information Nondiscrimination Act, 42 the receiving entity’s jurisdiction. records as a routine use to the party, U.S.C. 2000ff et seq.; Department of (2) Enforcement Disclosure. In the counsel, representative, or witness. Education, Personnel Management event that information in this system of (4) Employment, Benefit, and Instruction 771–1-Employee Grievances; records indicates, either on its face or in Contracting Disclosure. and, the Department of Education’s connection with other information, a (a) For Decisions by the Department. Collective Bargaining Agreement, violation or potential violation of any The Department may disclose a record Article 42-Grievance Procedure. applicable statute, regulation, or order to a Federal, State, or local agency of a competent authority, the maintaining civil, criminal, or other PURPOSE(S): Department may disclose the relevant relevant enforcement or other pertinent The information in this system is records to the appropriate agency, records, or to another public authority used: (1) To track, manage, and report whether foreign, Federal, State, Tribal, or professional organization, if on all data, events, and procedures or local, charged with the responsibility necessary to obtain information relevant related to pre-grievances (administrative of investigating or prosecuting that to a Department decision concerning the or negotiated); (2) to track, manage, and violation or charged with enforcing or hiring or retention of an employee or report on all data, events, and implementing the statute, Executive other personnel action, the issuance of procedures related to pre-EEO order, rule, regulation, or order issued a security clearance, the letting of a complaints referred to the ADR Center pursuant thereto. contract, or the issuance of a license, for alternative dispute resolution; (3) to (3) Litigation and ADR Disclosures. grant, or other benefit. track, manage, and report on all data, (a) Introduction. In the event that one (b) For Decisions by Other Public events, and procedures related to formal of the parties listed below is involved in Agencies and Professional EEO complaints referred to the ADR litigation or ADR, or has an interest in Organizations. The Department may Center for alternative dispute resolution; litigation ADR, the Department may disclose a record to a Federal, State, (4) to track, manage, and report on all disclose certain records to the parties local, or foreign agency or other public other data, events, and procedures described in paragraphs (b), (c) and (d) authority or professional organization, related to any workplace issue; (5) to of this routine use under the conditions in connection with the hiring or collect, analyze, and report data specified in those paragraphs: retention of an employee or other pertinent to the particular claim being (i) The Department, or any of its personnel action, the issuance of a asserted to include some Personally components; or security clearance, the reporting of an Identifiable Information (PII) for (ii) Any Department employee in his investigation of an employee, the letting periodic reports and analysis; (6) to or her official capacity; or of a contract, or the issuance of a maintain a record of the data provided (iii) Any Department employee in his license, grant, or other benefit, to the by employees requesting assistance; (7) or her individual capacity if the extent that the record is relevant and to act as a source for information Department of Justice (DOJ) has agreed necessary to the receiving entity’s necessary to fulfill Equal Employment to or has been requested to provide or decision on the matter. Opportunity Services’ alternative arrange for representation of the (5) Employee Grievance, Complaint or dispute resolution reporting employee; Conduct Disclosure. The Department requirements; and (8) to enable (iv) Any Department employee in his may disclose a record in this system of complaint resolution partners to review or her individual capacity where the records to another agency of the Federal

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Government if the record is relevant to request of that individual. The RETENTION AND DISPOSAL: one of the following proceedings member’s right to the information is no The records in this system are regarding a present or former employee greater than the right of the individual maintained in accordance with the of the Department: A complaint, a who requested it. General Records Schedule 1, item 27 grievance, or a disciplinary or (12) Disclosure to the OMB for Credit Alternative Dispute Resolution (ADR) competence determination proceeding. Reform Act (CRA) Support. The Files. The General Files, such as, The disclosure may only be made Department may disclose records to general correspondence and copies of during the course of the proceeding. OMB as necessary to fulfill CRA statutes, regulations, meeting minutes, (6) Labor Organization Disclosure. requirements. reports, statistical tabulations, The Department may disclose records (13) Disclosure in the Course of evaluations of the ADR program, and from this system to an arbitrator to Responding to a Breach of Data. The other records relating to the resolve disputes under a negotiated Department may disclose records from Department’s overall ADR program will grievance procedure or to officials of this system to appropriate agencies, be destroyed when 3 years old. A longer labor organizations recognized under 5 entities, and persons when: (a) The retention is authorized if records are U.S.C. chapter 71 when relevant and Department suspects or has confirmed needed for agency business. (N1–GRS– necessary to their duties of exclusive that the security or confidentiality of 03–2 item a). representation. information in the system of records has The Case Files cover records (7) Freedom of Information Act been compromised; (b) the Department documenting ADR proceedings and may (FOIA) and Privacy Act Advice has determined that as a result for the include an agreement to use ADR, Disclosure. The Department may suspected or confirmed compromise documentation of the settlement or disclose records to the DOJ and the there is a risk of harm to economic or discontinuance of the ADR case, parties’ Office of Management and Budget if the property interests, identity theft or written evaluations of the process and/ Department concludes that disclosure is fraud, or harm to the security or or the neutral third party mediator, and desirable or necessary in determining integrity of this system or other systems related correspondence. The Case Files whether particular records are required or programs (whether maintained by the will be destroyed 3 years after to be disclosed under the FOIA or the Department or another agency or entity) settlement is implemented or the case is Privacy Act. that rely upon the compromised (8) Disclosure to the DOJ. The discontinued. (N1–GRS–03–2 item b). information; and (c) the disclosure made Department may disclose records to the to such agencies, entities, and persons is SYSTEM MANAGER(S) AND ADDRESS: DOJ to the extent necessary for reasonably necessary to assist in Director, Alternative Dispute obtaining DOJ advice on any matter connection with the Department’s Resolution Center, Office of relevant to an audit, inspection, or other efforts to respond to the suspected or Management, U.S. Department of inquiry related to the programs covered confirmed compromise and prevent, Education, Capitol Place Building, 80 F. by this system. (9) Contract Disclosure. If the minimize, or remedy such harm. Street, NW., Room 408C/Mail Stop 4000, Washington, DC 20001–1528. Department contracts with an entity for DISCLOSURE TO CONSUMER REPORTING the purposes of performing any function AGENCIES: NOTIFICATION PROCEDURE: that requires disclosure of records in Not applicable to this notice. If you wish to determine whether a this system to employees of the record exists regarding you in this POLICIES AND PRACTICES FOR STORING, contractor, the Department may disclose system of records, contact the system the records to those employees. Before RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: manager. Requests must meet the entering into such a contract, the requirements in the regulations at 34 Department shall require the contractor STORAGE: CFR 5b.5, including proof of identity. to maintain Privacy Act safeguards as Records are maintained in paper files required under 5 U.S.C. 552a(m) with in filing cabinets and electronically on RECORD ACCESS PROCEDURES: respect to the records in the system. a computerized tracking system, and in If you wish to gain access to a record (10) Research Disclosure. The an email system. in this system, contact the system Department may disclose records to a manager. Requests by an individual for researcher if an appropriate official of RETRIEVABILITY: access to a record must meet the the Department determines that the Records are indexed by case tracking requirements the regulations at 34 CFR individual or organization to which the number and can be retrieved by the 5b.5, including proof of identity. disclosure would be made is qualified to name of the non-Government party, carry out specific research related to whether applicant or employee. CONTESTING RECORD PROCEDURES: functions or purposes of this system of If you wish to contest the content of records. The official may disclose SAFEGUARDS: a record regarding you in this system of records from this system of records to Access to and use of the hard-copy records, contact the system manager. that researcher solely for the purpose of records and the electronic system is Your request must meet the carrying out that research related to the limited to those persons with a ‘‘need- requirements of the Act regulations at functions or purposes of this system of to-know’’ and whose official duties 34 CFR 5b.7, including proof of identity. records. The researcher shall be require such access. Hard-copy records required to maintain Privacy Act are stored in file cabinets in an office RECORD SOURCE CATEGORIES: safeguards with respect to the disclosed location that is kept locked after the Information in this system of records records. close of the business day. Personnel is supplied from the following sources: (11) Congressional Member screening is employed to prevent Directly by the individual filing a Disclosure. The Department may unauthorized disclosure. Computers are request for resolution of an EEO pre- disclose records to a member of password protected. The system is complaint, EEO formal complaint or Congress from the record of an designed with security measures to pre-grievance, from information individual in response to an inquiry control an individual user’s ability to supplied by the individual, or by from the member made at the written access and alter records. testimony of witnesses, employee

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representatives, or Department free at 1–866–208–3676, or for TTY, which the filing responds; (3) furnish employees/officials. (202) 502–8659. Although the the name, address, and telephone Commission strongly encourages number of the person submitting the EXEMPTIONS CLAIMED FOR THE SYSTEM: electronic filing, documents may also be filing; and (4) otherwise comply with None. paper-filed. To paper-file, mail an the requirements of 18 CFR 385.2001 [FR Doc. 2012–27431 Filed 11–8–12; 8:45 am] original and seven copies to: Kimberly through 385.2005. All comments, BILLING CODE 4000–01–P D. Bose, Secretary, Federal Energy recommendations, terms and conditions Regulatory Commission, 888 First Street or prescriptions must set forth their NE., Washington, DC 20426. evidentiary basis and otherwise comply DEPARTMENT OF ENERGY The Commission’s Rules of Practice with the requirements of 18 CFR 4.34(b). require all intervenors filing documents Agencies may obtain copies of the Federal Energy Regulatory with the Commission to serve a copy of application directly from the applicant. Commission that document on each person on the Each filing must be accompanied by official service list for the project. proof of service on all persons listed on [Project No. 13287–004] Further, if an intervenor files comments the service list prepared by the or documents with the Commission City of New York; Notice of Application Commission in this proceeding, in relating to the merits of an issue that accordance with 18 CFR 4.34(b), and Ready for Environmental Analysis and may affect the responsibilities of a Soliciting Comments, 385.2010. particular resource agency, they must You may also register online at Recommendations, Terms and also serve a copy of the document on Conditions, and Prescriptions http://www.ferc.gov/docs-filing/ that resource agency. esubscription.asp to be notified via k. This application has been accepted email of new filings and issuances Take notice that the following and is now ready for environmental hydroelectric application has been filed related to this or other pending projects. analysis. For assistance, contact FERC Online with the Commission and is available l. Project facilities would include: (1) Support. for public inspection. An existing 2,800-foot-long, 45-foot- a. Type of Application: Major project, wide earthen embankment dam with a n. Public notice of the filing of the existing dam. crest elevation of 1,175.0 feet above initial development application, which b. Project No.: 13287–004. mean sea level; (2) an existing 800-foot- has already been given, established the c. Date filed: February 29, 2012. long stone masonry spillway; (3) an due date for filing competing d. Applicant: City of New York. existing 12-mile-long, 4,670-acre applications or notices of intent. Under e. Name of Project: Cannonsville impoundment (Cannonsville Reservoir); the Commission’s regulations, any Hydroelectric Project. (4) four proposed penstocks branching competing development application f. Location: On the West Branch of the from an existing 12-foot-diameter must be filed in response to and in Delaware River, near the Township of intake; (5) a proposed 168-foot-long by compliance with public notice of the Deposit, Delaware County, New York. 54-foot-wide powerhouse containing initial development application. No The project does not occupy any federal four horizontal shaft Francis generating competing applications or notices of lands. units; (6) a proposed tailrace occupying intent may be filed in response to this g. Filed Pursuant to: Federal Power approximately one acre; (7) a proposed notice. Act, 16 U.S.C. 791(a)–825(r). transmission system consisting of a 150- o. A license applicant must file no h. Applicant Contact: Anthony J. foot-long underground and 1,200-foot- later than 60 days following the date of Fiore, Chief of Staff—Operations, New long overhead 12.47-kilovolt (kV) line, a issuance of this notice: (1) A copy of the York City Department of Environmental substation, and a 460-foot-long overhead water quality certification; (2) a copy of Protection, 59–17 Junction Blvd., 46-kV line; and (8) appurtenant the request for certification, including Flushing, NY 11373–5108, (718) 595– facilities. The project would have a total proof of the date on which the certifying 6529 or [email protected]. installed capacity of 14.08 megawatts agency received the request; or (3) i. FERC Contact: John Mudre, (202) and would generate approximately evidence of waiver of water quality 502–8902 or [email protected]. 42,281 megawatt-hours of electricity certification. j. Deadline for filing comments, annually. Dated: November 2, 2012. recommendations, terms and m. A copy of the application is Kimberly D. Bose, conditions, and prescriptions: 60 days available for review at the Commission Secretary. from the issuance date of this notice; in the Public Reference Room or may be reply comments are due 105 days from viewed on the Commission’s Web site at [FR Doc. 2012–27407 Filed 11–8–12; 8:45 am] the issuance date of this notice. http://www.ferc.gov using the BILLING CODE 6717–01–P All documents may be filed ‘‘eLibrary’’ link. Enter the docket electronically via the Internet. See 18 number excluding the last three digits in DEPARTMENT OF ENERGY CFR 385.2001(a)(1)(iii) and the the docket number field to access the instructions on the Commission’s Web document. For assistance, contact FERC Federal Energy Regulatory site http://www.ferc.gov/docs-filing/ Online Support. A copy is also available Commission efiling.asp. Commenters can submit for inspection and reproduction at the brief comments up to 6,000 characters, address in item h above. [Project No. 13739–002] without prior registration, using the All filings must (1) bear in all capital eComment system at http://www.ferc. letters the title ‘‘COMMENTS’’, ‘‘REPLY Lock+ Hydro Friends Fund XLII, LLC; gov/docs-filing/ecomment.asp. You COMMENTS’’, Notice of Application Accepted for must include your name and contact ‘‘RECOMMENDATIONS,’’ ‘‘TERMS Filing and Soliciting Motions To information at the end of your AND CONDITIONS,’’ or Intervene and Protests comments. For assistance, please ‘‘PRESCRIPTIONS;’’ (2) set forth in the contact FERC Online Support at heading the name of the applicant and Take notice that the following [email protected] or toll the project number of the application to hydroelectric application has been filed

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with the Commission and is available l. The proposed project would utilize applicant, and must include an for public inspection. the existing U.S. Army Corps of unequivocal statement of intent to a. Type of Application: Major Original Engineers’ Braddock Locks and Dam submit a development application. A License and the Braddock Pool, and would notice of intent must be served on the b. Project No.: 13739–002 consist of the following new facilities: applicant(s) named in this public notice. c. Date filed: September 17, 2012 (1) A new powerhouse with five Anyone may submit a protest or a d. Applicant: Lock+ Hydro Friends turbine-generators having a total motion to intervene in accordance with Fund XLII, LLC installed capacity of 3,750 kilowatts; (2) the requirements of Rules of Practice e. Name of Project: Braddock Locks a new approximately 3,450-foot-long, and Procedure, 18 CFR 385.210, and Dam Hydroelectric Project 23-kilovolt electric distribution line; (3) 385.211, and 385.214. In determining f. Location: At the existing U.S. Army a switchyard and control room; and (4) the appropriate action to take, the Corps of Engineers’ Braddock Locks and appurtenant facilities. The average Commission will consider all protests Dam on the Monongahela River, in annual generation is estimated to be filed, but only those who file a motion Allegheny County, Pennsylvania. The 25,020 megawatt-hours. to intervene in accordance with the project would occupy about 0.19 acre of The proposed project would deploy Commission’s Rules may become a federal lands. hydropower turbines within a patented party to the proceeding. Any protests or g. Filed Pursuant to: Federal Power ‘‘Large Frame Module’’ (LFM) that motions to intervene must be received Act 16 USC 791(a)–825(r). would be deployed on the south (river on or before the specified deadline date h. Applicant Contact: Mr. Mark R. left) side of the dam, opposite the for the particular application. TM Stover, Lock+ Hydro Friends Fund location of the existing navigational When the application is ready for XLII, LLC, c/o Hydro Green Energy, locks and at the upstream face of the environmental analysis, the LLC, 900 Oakmont Lane, Suite 310, existing left closure weir. The proposed Commission will issue a public notice Westmont, IL 60559; (877) 556–6566 modular, low environmental impact requesting comments, ext. 711; email—[email protected]. powerhouse would be approximately recommendations, terms and i. FERC Contact: John Mudre at (202) 60.4 feet long, 16.6 feet wide, and 40 conditions, or prescriptions. 502–8902; or email at feet high, and constructed of structural- All filings must (1) bear in all capital [email protected]. grade steel. The powerhouse will bear letters the title ‘‘PROTEST’’ or j. Deadline for filing motions to on a concrete foundation on rock that is ‘‘MOTION TO INTERVENE,’’ ‘‘NOTICE intervene and protests: 60 days from the anchored to the existing left closure OF INTENT TO FILE COMPETING issuance date of this notice. weir. A trash rack with 6-inch openings APPLICATION,’’ or ‘‘COMPETING All documents may be filed would be placed at the powerhouse APPLICATION;’’ (2) set forth in the electronically via the Internet. See 18 intake to increase safety and protect the heading the name of the applicant and CFR 385.2001(a)(1)(iii) and the turbines from large debris. the project number of the application to instructions on the Commission’s Web m. A copy of the application is which the filing responds; (3) furnish site http://www.ferc.gov/docs-filing/ available for review at the Commission the name, address, and telephone efiling.asp. Commenters can submit in the Public Reference Room or may be number of the person protesting or brief comments up to 6,000 characters, viewed on the Commission’s Web site at intervening; and (4) otherwise comply without prior registration, using the http://www.ferc.gov using the with the requirements of 18 CFR eComment system at http:// ‘‘eLibrary’’ link. Enter the docket 385.2001 through 385.2005. Agencies www.ferc.gov/docs-filing/ number excluding the last three digits in may obtain copies of the application ecomment.asp. You must include your the docket number field to access the directly from the applicant. A copy of name and contact information at the end document. For assistance, contact FERC any protest or motion to intervene must of your comments. For assistance, Online Support. A copy is also available be served upon each representative of please contact FERC Online Support at for inspection and reproduction at the the applicant specified in the particular [email protected] or toll address in item h above. application. free at 1–866–208–3676, or for TTY, You may also register online at (202) 502–8659. Although the http://www.ferc.gov/docs-filing/ Dated: November 2, 2012. Commission strongly encourages esubscription.asp to be notified via Kimberly D. Bose, electronic filing, documents may also be email of new filings and issuances Secretary. paper-filed. To paper-file, mail an related to this or other pending projects. [FR Doc. 2012–27410 Filed 11–8–12; 8:45 am] original and seven copies to: Kimberly For assistance, contact FERC Online BILLING CODE 6717–01–P D. Bose, Secretary, Federal Energy Support. Regulatory Commission, 888 First Street n. Any qualified applicant desiring to NE., Washington, DC 20426. file a competing application must DEPARTMENT OF ENERGY The Commission’s Rules of Practice submit to the Commission, on or before and Procedures require all intervenors the specified intervention deadline date, Federal Energy Regulatory filing documents with the Commission a competing development application, Commission to serve a copy of that document on or a notice of intent to file such an Combined Notice of Filings #2 each person on the official service list application. Submission of a timely for the project. Further, if an intervenor notice of intent allows an interested Take notice that the Commission files comments or documents with the person to file the competing received the following electric rate Commission relating to the merits of an development application no later than filings: issue that may affect the responsibilities 120 days after the specified intervention Docket Numbers: ER10–1484–005. of a particular resource agency, they deadline date. Applications for Applicants: Shell Energy North must also serve a copy of the document preliminary permits will not be America (U.S.), L.P. on that resource agency. accepted in response to this notice. Description: Shell Energy North k. This application has been accepted A notice of intent must specify the America (U.S.), L.P. submits updated for filing, but is not ready for exact name, business address, and market power analysis for the Northeast environmental analysis at this time. telephone number of the prospective region.

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Filed Date: 10/31/12. Energy Supply Agreement with the Restated Interconnection and Power and Accession Number: 20121031–5397. Village of Cadott, Wisconsin. Energy Supply Agreement with the Comments Due: 5 p.m. ET 11/21/12. Filed Date: 10/31/12. Village of Trempealeau, Wisconsin. Docket Numbers: ER13–266–000. Accession Number: 20121031–5401. Filed Date: 10/31/12. Applicants: Duke Energy Carolinas, Comments Due: 5 p.m. ET 11/21/12. Accession Number: 20121031–5412. LLC. Docket Numbers: ER13–275–000. Comments Due: 5 p.m. ET 11/21/12. Description: Amendment to Rate Applicants: Northern States Power Docket Numbers: ER13–281–000. Schedule No. 318–2013 Confirmation to Company, a Wisconsin corporation. Applicants: Star Energy Partners LLC. be effective 1/1/2013. Description: Northern States Power Description: Star Energy Partners Filed Date: 11/1/12. Company, a Wisconsin corporation Market Based Rate Tariff to be effective Accession Number: 20121101–5017. submits a Notice of Cancellation of the 11/20/2012. Comments Due: 5 p.m. ET 11/23/12. Restated Interconnection and Power and Filed Date: 11/1/12. Docket Numbers: ER13–269–000. Energy Supply Agreement with the City Accession Number: 20121101–5102. Comments Due: 5 p.m. ET 11/23/12. Applicants: PJM Interconnection, of Bloomer, Wisconsin. L.L.C. Filed Date: 10/31/12. Docket Numbers: ER13–282–000. Description: Original Service Accession Number: 20121031–5407. Applicants: Wabash Valley Power Agreement No. 3403; Queue No. U3–004 Comments Due: 5 p.m. ET 11/21/12. Association, Inc. Description: Rate Schedule to be effective 9/28/2012. Docket Numbers: ER13–276–000. Amendments—November 2012 to be Filed Date: 11/1/12. Applicants: Northern States Power effective 7/6/2010. Accession Number: 20121101–5055. Company, a Wisconsin corporation. Comments Due: 5 p.m. ET 11/23/12. Filed Date: 11/1/12. Description: Northern States Power Accession Number: 20121101–5104. Docket Numbers: ER13–270–000. Company, a Wisconsin corporation Comments Due: 5 p.m. ET 11/23/12. Applicants: New England Power Pool submits a Notice of Cancellation of the Docket Numbers: ER13–283–000. Participants Committee, ISO New Restated Interconnection and Power and Applicants: Public Service Company England Inc. Energy Supply Agreement with the City of Colorado. of Cornell, Wisconsin. Description: Elimination of Internal Description: 2012–11–1-Annual FP2P Filed Date: 10/31/12. Bilateral Transactions for Regulation to Rate Filing to be effective 1/1/2013. be effective 1/1/2013. Accession Number: 20121031–5408. Filed Date: 11/1/12. Filed Date: 11/1/12. Comments Due: 5 p.m. ET 11/21/12. Accession Number: 20121101–5105. Accession Number: 20121101–5067. Docket Numbers: ER13–277–000. Comments Due: 5 p.m. ET 11/23/12. Comments Due: 5 p.m. ET 11/23/12. Applicants: The Detroit Edison Take notice that the Commission Docket Numbers: ER13–271–000. Company. received the following electric securities Applicants: Alabama Power Description: Update Seller Category filings: Company. Status to be effective 11/2/2012. Docket Numbers: ES11–40–002. Description: Cancellation of Rate Filed Date: 11/1/12. Applicants: Entergy Services, Inc., Schedule MUN–1 to be effective 1/1/ Accession Number: 20121101–5098. Entergy Arkansas, Inc., Entergy Gulf 2013. Comments Due: 5 p.m. ET 11/23/12. States Louisiana, L.L.C., Entergy Filed Date: 11/1/12. Docket Numbers: ER13–278–000. Louisiana, LLC, Entergy Mississippi, Accession Number: 20121101–5083. Applicants: Northern States Power Inc., Entergy New Orleans, Inc., Entergy Comments Due: 5 p.m. ET 11/23/12. Company, a Wisconsin corporation. Texas, Inc. Docket Numbers: ER13–272–000. Description: Northern States Power Description: Joint Application for Applicants: Startrans IO, LLC. Company, a Wisconsin corporation Temporary Modification of Existing Description: Startrans IO Proposed submits a Notice of Cancellation of the Authorizations under Section 204 of the Decrease in Base Transmission Revenue Restated Interconnection and Power and Federal Power Act of Entergy Services, Requirement to be effective 1/1/2013. Energy Supply Agreement with the City Inc., et al. Filed Date: 11/1/12. of Wakefield, Wisconsin. Filed Date: 10/31/12. Accession Number: 20121101–5084. Filed Date: 10/31/12. Accession Number: 20121031–5413. Comments Due: 5 p.m. ET 11/23/12. Accession Number: 20121031–5410. Comments Due: 5 p.m. ET 11/21/12. Docket Numbers: ER13–273–000. Comments Due: 5 p.m. ET 11/21/12. Take notice that the Commission Applicants: Northern States Power Docket Numbers: ER13–279–000. received the following land acquisition Company, a Wisconsin corporation. Applicants: Northern States Power reports: Description: Northern States Power Company, a Wisconsin corporation. Docket Numbers: LA12–3–000. Company, a Wisconsin corporation Description: Northern States Power Applicants: Bluegrass Generation submits a Notice of Cancellation of the Company, a Wisconsin corporation Company, L.L.C., Blythe Energy, LLC, Restated Interconnection and Power and submits a Notice of Cancellation of the Calhoun Power Company, LLC, Energy Supply Agreement with the City Restated Interconnection and Power and Cherokee County Cogeneration Partners, of Barron, Wisconsin. Energy Supply Agreement with the City LLC, DeSoto County Generating Filed Date: 10/31/12. of Spooner, Wisconsin. Company, LLC, Doswell Limited Accession Number: 20121031–5398. Filed Date: 10/31/12. Partnership, Las Vegas Power Company, Comments Due: 5 p.m. ET 11/21/12. Accession Number: 20121031–5411. LLC, LS Power Marketing, LLC, LSP Docket Numbers: ER13–274–000. Comments Due: 5 p.m. ET 11/21/12. Safe Harbor Holdings, LLC, LSP Applicants: Northern States Power Docket Numbers: ER13–280–000. University Park, LLC, Renaissance Company, a Wisconsin corporation. Applicants: Northern States Power Power, L.L.C., Riverside Generating Description: Northern States Power Company, a Wisconsin corporation. Company, L.L.C., Rocky Road Power, Company, a Wisconsin corporation Description: Northern States Power LLC, Tilton Energy LLC, University Park submits a Notice of Cancellation of the Company, a Wisconsin corporation Energy, LLC, and Wallingford Energy Restated Interconnection and Power and submits a Notice of Cancellation of the LLC, LLC.

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Description: Quarterly Land Description: PFSA Cleanup to be Accession Number: 20121101–5147. Acquisition Report of the LS Power effective 12/1/2012. Comments Due: 5 p.m. ET 11/13/12. Development, LLC MBR Sellers. Filed Date: 11/1/12. Docket Numbers: RP13–253–000. Filed Date: 10/31/12. Accession Number: 20121101–5042. Applicants: Northern Border Pipeline Accession Number: 20121031–5409. Comments Due: 5 p.m. ET 11/13/12. Company. Comments Due: 5 p.m. ET 11/21/12. Docket Numbers: RP13–244–000. Description: Ameren Illinois Rate Take notice that the Commission Applicants: Columbia Gas Change to be effective 11/1/2012. received the following public utility Transmission, LLC. Filed Date: 11/1/12. holding company filings: Description: PFSA Clean Up to be Accession Number: 20121101–5151. Docket Numbers: PH13–3–000. effective 12/1/2012. Comments Due: 5 p.m. ET 11/13/12. Applicants: DTE Energy Company. Filed Date: 11/1/12. Docket Numbers: RP13–254–000. Description: DTE Energy Company Accession Number: 20121101–5047. Applicants: Millennium Pipeline submits Form 65 and Form 65–B Notice Comments Due: 5 p.m. ET 11/13/12. Company, LLC. of Change. Docket Numbers: RP13–245–000. Description: Negotiated Rate Service Filed Date: 10/31/12. Applicants: Central Kentucky Agmts No. 5582, 135770 to be effective Accession Number: 20121031–5400. Transmission Company. 11/1/2012. Comments Due: 5 p.m. ET 11/21/12. Description: PFSA Cleanup to be Filed Date: 11/1/12. The filings are accessible in the effective 12/1/2012. Accession Number: 20121101–5160. Commission’s eLibrary system by Filed Date: 11/1/12. Comments Due: 5 p.m. ET 11/13/12. clicking on the links or querying the Accession Number: 20121101–5053. Docket Numbers: RP13–255–000. docket number. Comments Due: 5 p.m. ET 11/13/12. Applicants: Granite State Gas Any person desiring to intervene or Docket Numbers: RP13–246–000. Transmission, Inc. protest in any of the above proceedings Description: Non-Conforming must file in accordance with Rules 211 Applicants: Hardy Storage Company, LLC. Contracts to be effective 11/1/2012. and 214 of the Commission’s Filed Date: 11/1/12. Regulations (18 CFR 385.211 and Description: PFSA Cleanup Filing to be effective 12/1/2012. Accession Number: 20121101–5164. 385.214) on or before 5:00 p.m. Eastern Comments Due: 5 p.m. ET 11/13/12. Filed Date: 11/1/12. time on the specified comment date. Docket Numbers: RP13–256–000. Protests may be considered, but Accession Number: 20121101–5056. Comments Due: 5 p.m. ET 11/13/12. Applicants: Equitrans, L.P. intervention is necessary to become a Description: Equitrans, L.P. submits Docket Numbers: RP13–247–000. party to the proceeding. Operational Purchases and Sales Report Applicants: ANR Storage Company. eFiling is encouraged. More detailed for the twelve month period ended Description: J. Aron FS Agmt to be information relating to filing August 31, 2012. effective 11/1/2012. requirements, interventions, protests, Filed Date: 11/1/12. Filed Date: 11/1/12. service, and qualifying facilities filings Accession Number: 20121101–5184. can be found at: http://www.ferc.gov/ Accession Number: 20121101–5057. Comments Due: 5 p.m. ET 11/13/12. Comments Due: 5 p.m. ET 11/13/12. docs-filing/efiling/filing-req.pdf. For Docket Numbers: RP13–257–000. other information, call (866) 208–3676 Docket Numbers: RP13–248–000. Applicants: Destin Pipeline Company, (toll free). For TTY, call (202) 502–8659. Applicants: Columbia Gulf L.L.C. Dated: November 1, 2012. Transmission Company. Description: Fuel Retention Description: PFSA Cleanup to be Nathaniel J. Davis, Sr., Adjustment to be effective 12/1/2012. effective 12/1/2012. Filed Date: 11/1/12. Deputy Secretary. Filed Date: 11/1/12. [FR Doc. 2012–27388 Filed 11–8–12; 8:45 am] Accession Number: 20121101–5187. Accession Number: 20121101–5059. Comments Due: 5 p.m. ET 11/13/12. BILLING CODE 6717–01–P Comments Due: 5 p.m. ET 11/13/12. Docket Numbers: RP13–258–000. Docket Numbers: RP13–249–000. Applicants: Alliance Pipeline L.P. Applicants: ANR Pipeline Company. Description: November 6–15 2012 DEPARTMENT OF ENERGY _ Description: Nexen Integrys Agmts to Auction to be effective 11/6/2012. Federal Energy Regulatory be effective 11/1/2012. Filed Date: 11/2/12. Commission Filed Date: 11/1/12. Accession Number: 20121102–5151. Accession Number: 20121101–5100. Comments Due: 5 p.m. ET 11/14/12. Combined Notice of Filings Comments Due: 5 p.m. ET 11/13/12. Docket Numbers: RP13–259–000. Take notice that the Commission has Docket Numbers: RP13–250–000. Applicants: ANR Pipeline Company. _ received the following Natural Gas Applicants: Algonquin Gas Description: BP Energy Exploration to Pipeline Rate and Refund Report filings: Transmission, LLC. be effective 11/1/2012. Description: Brooklyn Union Gas Filed Date: 11/2/12. Filings Instituting Proceedings Company Releases November 2012 Accession Number: 20121102–5195. Docket Numbers: CP13–11–000. Ramapo to be effective 11/1/2012. Comments Due: 5 p.m. ET 11/14/12. Applicants: Peoples TWP LLC. Filed Date: 11/1/12. Any person desiring to intervene or Description: Application for Limited Accession Number: 20121101–5101. protest in any of the above proceedings Jurisidiction Blanket Certificate of Comments Due: 5 p.m. ET 11/13/12. must file in accordance with Rules 211 Peoples TWP LLC. Docket Numbers: RP13–252–000. and 214 of the Commission’s Filed Date: 10/31/12. Applicants: CenterPoint Energy Gas Regulations (18 CFR 385.211 and Accession Number: 20121101–0003. Transmission Comp. 385.214) on or before 5:00 p.m. Eastern Comments Due: 5 p.m. ET 11/13/12. Description: CEGT LLC—Neg Rate time on the specified comment date. Docket Numbers: RP13–243–000. Filing—November 2012 to be effective Protests may be considered, but Applicants: Crossroads Pipeline 11/1/2012. intervention is necessary to become a Company. Filed Date: 11/1/12. party to the proceeding.

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Filings in Existing Proceedings Assets under Section 203 of the Federal Applicants: Blackwell Wind, LLC, Docket Numbers: RP12–610–001. Power Act of Appalachian Power FPL Energy Oklahoma Wind, LLC, FPL Applicants: Columbia Gas Company and Wheeling Power Energy Sooner Wind, LLC, Minco Wind Transmission, LLC. Company. Interconnection Services, LLC, Minco Description: South Jersey Compliance Filed Date: 10/31/12. Wind, LLC, Minco Wind II, LLC, Filing—Inservice. Accession Number: 20121031–5337. NextEra Energy Power Marketing, LLC. Filed Date: 11/1/12. Comments Due: 5 p.m. e.t. 12/17/12. Description: Notification of Non- Accession Number: 20121101–5159. Docket Numbers: EC13–28–000. material Change in Status of the NextEra Comments Due: 5 p.m. ET 11/13/12. Applicants: Appalachian Power Resource Entities. Docket Numbers: RP13–218–001. Company, Kentucky Power Company, Filed Date: 10/31/12. Applicants: Carolina Gas AEP Generation Resources Inc. Accession Number: 20121031–5393. Transmission Corporation. Description: Application for Comments Due: 5 p.m. e.t. 11/21/12. Description: BG Negotiated Rate Authorization to Transfer Jurisdictional Docket Numbers: ER12–2291–000. Filing Amendment to be effective 11/1/ Assets under Section 203 of the Federal Applicants: New England Power 2012. Power Act of Appalachian Power Company. Filed Date: 11/1/12. Company, Kentucky Power Company Description: Refund Report of New Accession Number: 20121101–5124. and AEP Generation Resources Inc. England Power Company in Docket No. Comments Due: 5 p.m. ET 11/13/12. Filed Date: 10/31/12. ER12–2291 to be effective N/A. Accession Number: 20121031–5339. Any person desiring to protest in any Filed Date: 10/31/12. Comments Due: 5 p.m. e.t. 12/17/12. the above proceedings must file in Accession Number: 20121031–5268. accordance with Rule 211 of the Docket Numbers: EC13–29–000. Comments Due: 5 p.m. e.t. 11/21/12. Commission’s Regulations (18 CFR Applicants: Kiowa Power Partners, LLC, Tenaska Energy, Inc., Tenaska Docket Numbers: ER12–2304–002. 385.211) on or before 5:00 p.m. Eastern Applicants: Green Mountain Power time on the specified comment date. Energy Holdings, LLC, Tenaska Oklahoma, Inc., Diamond Pittsburg, LP, Corporation, ISO New England Inc. The filings are accessible in the Description: Green Mountain Power Commission’s eLibrary system by Diamond Oklahoma, LP. Description: Kiowa Power Partners, Notice of Effective Date Schedule 21 clicking on the links or querying the and Schedule 20A to be effective 10/1/ docket number. LLC, et al. Joint Application For Approval Under Section 203 of the 2012. eFiling is encouraged. More detailed Filed Date: 10/31/12. information relating to filing Federal Power Act and Request for Shortened Comment Period and Accession Number: 20121031–5030. requirements, interventions, protests, Comments Due: 5 p.m. e.t. 11/21/12. and service can be found at: http:// Expedited Action. Docket Numbers: ER13–150–001. www.ferc.gov/docs-filing/efiling/filing- Filed Date: 10/31/12. Applicants: Northern Indiana Public req.pdf. For other information, call (866) Accession Number: 20121031–5387. Service Company, Midwest 208–3676 (toll free). For TTY, call (202) Comments Due: 5 p.m. e.t. 11/21/12. Independent Transmission System 502–8659. Take notice that the Commission received the following electric rate Operator, Inc. Dated: November 5, 2012. filings: Description: 10–31–12 NIPSCO Nathaniel J. Davis, Sr., Docket Numbers: ER11–2780–007. Amendment to be effective 1/1/2013. Deputy Secretary. Applicants: Safe Harbor Water Power Filed Date: 10/31/12. [FR Doc. 2012–27386 Filed 11–8–12; 8:45 am] Corporation. Accession Number: 20121031–5259. BILLING CODE 6717–01–P Description: Notice of Change in Comments Due: 5 p.m. e.t. 11/21/12. Status of Safe Harbor Water Power Docket Numbers: ER13–226–000. Corporation. Applicants: Southern California DEPARTMENT OF ENERGY Filed Date: 10/31/12. Edison Company. Accession Number: 20121031–5353. Description: 2013 TRBAA Update Federal Energy Regulatory Comments Due: 5 p.m. e.t. 11/21/12. Filing to be effective 1/1/2013. Commission Docket Numbers: ER12–60–003; Filed Date: 10/31/12. ER10–1632–003; ER10–1616–001; Combined Notice of Filings #1 Accession Number: 20121031–5003. ER10–1585–001; ER10–1594–001; Comments Due: 5 p.m. e.t. 11/21/12. Take notice that the Commission ER10–1617–001; ER10–1628–001. Docket Numbers: ER13–227–000. Applicants: New Covert Generating received the following electric corporate Applicants: Southern California Company, LLC, Tenaska Power Services filings: Edison Company. Co., Tenaska Power Management, LLC, Docket Numbers: EC13–26–000. Description: 2013 RSBAA Update Alabama Electric Marketing, LLC, Applicants: Ohio Power Company, Filing to be effective 1/1/2013. California Electric Marketing, LLC, New AEP Generation Resources Inc. Filed Date: 10/31/12. Mexico Electric Marketing, LLC, Texas Description: Application for Accession Number: 20121031–5014. Electric Marketing, LLC. Authorization to Transfer Jurisdictional Comments Due: 5 p.m. e.t. 11/21/12. Assets under Section 203 of the Federal Description: Updated Market Power Power Act of Ohio Power Company and Analysis for the Central Region on Docket Numbers: ER13–228–000. AEP Generation Resources Inc. behalf of Tenaska Power Management, Applicants: Pacific Gas and Electric Filed Date: 10/31/12. LLC, et al. Company. Accession Number: 20121031–5336. Filed Date: 10/31/12. Description: CCSF IA—39th Quarterly Comments Due: 5 p.m. e.t. 11/30/12. Accession Number: 20121031–5351. Filing of Facilities Agreements to be Docket Numbers: EC13–27–000. Comments Due: 5 p.m. e.t. 11/21/12. effective 9/30/2012. Applicants: Appalachian Power Docket Numbers: ER12–569–001; Filed Date: 10/31/12. Company, Wheeling Power Company. 1920–002; ER10–1928–002; ER12–895– Accession Number: 20121031–5016. Description: Application for 001; ER10–2720–002; ER11–4428–002; Comments Due: 5 p.m. e.t. 11/21/12. Authorization to Transfer Jurisdictional ER10–1971–006. Docket Numbers: ER13–229–000.

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Applicants: Green Mountain Power Comments Due: 5 p.m. e.t. 11/30/12. Filed Date: 10/31/12. Corporation, ISO New England Inc. Docket Numbers: ER13–237–000. Accession Number: 20121031–5125. Description: GMP—Notice of Applicants: Ohio Power Company. Comments Due: 5 p.m. e.t. 11/21/12. Succession for Service Agreement No. Description: Bridge Agreement Docket Numbers: ER13–245–000. 69 to be effective 10/1/2012. Concurrence to be effective 1/1/2014. Applicants: Green Mountain Power Filed Date: 10/31/12. Filed Date: 10/31/12. Corporation, Central Vermont Public Accession Number: 20121031–5029. Accession Number: 20121031–5105. Service Corporation. Comments Due: 5 p.m. e.t. 11/21/12. Comments Due: 5 p.m. e.t. 11/30/12. Description: Cancellation of Central Docket Numbers: ER13–230–000. Docket Numbers: ER13–238–000. Vermont eTariff Database to be effective Applicants: Northern Iowa Applicants: Appalachian Power 10/31/2012. Filed Date: 10/31/12. Windpower II LLC. Company. Description: Corrected Tariff Accession Number: 20121031–5136. Description: Sporn and Mitchell Comments Due: 5 p.m. e.t. 11/21/12. Revisions to be effective 6/30/2012. Operating Agreements to be effective 1/ Filed Date: 10/31/12. 1/2014. Docket Numbers: ER13–246–000. Applicants: Southern California Accession Number: 20121031–5066. Filed Date: 10/31/12. Comments Due: 5 p.m. e.t. 11/21/12. Accession Number: 20121031–5106. Edison Company. Description: SCE 2013 Update ETC Docket Numbers: ER13–231–000. Comments Due: 5 p.m. e.t. 12/17/12. Reliability Services Rate to be effective Applicants: Northern States Power Docket Numbers: ER13–239–000. 1/1/2013. Company, a Minnesota corporation. Applicants: Kentucky Power Filed Date: 10/31/12. Description: 2012–10–31-Ada-Kasota- Company. Accession Number: 20121031–5165. Intercon-Agmnts to be effective 12/31/ Description: Mitchell Operating Comments Due: 5 p.m. e.t. 11/21/12. 2012. Agreement Concurrence to be effective Docket Numbers: ER13–247–000. Filed Date: 10/31/12. 1/1/2014. Applicants: NV Energy, Inc. Accession Number: 20121031–5067. Filed Date: 10/31/12. Description: Transmission Rate Comments Due: 5 p.m. e.t. 11/21/12. Accession Number: 20121031–5107. Case—SPPC to be effective 1/1/2013. Docket Numbers: ER13–232–000. Comments Due: 5 p.m. e.t. 12/17/12. Filed Date: 10/31/12. Applicants: AEP Generation Docket Numbers: ER13–240–000. Accession Number: 20121031–5179. Resources Inc. Applicants: AEP Generation Comments Due: 5 p.m. e.t. 11/21/12. Description: Ohio Power Supply Resources Inc. Docket Numbers: ER13–249–000. Agreement to be effective 1/1/2014. Description: Sporn Operating Applicants: Southwest Power Pool, Filed Date: 10/31/12. Agreement Concurrence to be effective Inc. Accession Number: 20121031–5096. 1/1/2014. Description: 1313R6 Oklahoma Gas & Comments Due: 5 p.m. e.t. 11/30/12. Filed Date: 10/31/12. Electric NITSA NOA to be effective 10/ Docket Numbers: ER13–233–000. Accession Number: 20121031–5109. 1/2012. Applicants: Appalachian Power Comments Due: 5 p.m. e.t. 12/17/12. Filed Date: 10/31/12. Company. Docket Numbers: ER13–241–000. Accession Number: 20121031–5195. Description: Power Coordination Applicants: PJM Interconnection, Comments Due: 5 p.m. e.t. 11/21/12. Agreement and Bridge Agreement to be L.L.C. Docket Numbers: ER13–250–000. effective 1/1/2014. Description: Original SA No. 3410; Applicants: Luminescent Systems, Filed Date: 10/31/12. Queue No. W4–029 & Y1–075 (Reeves Inc. Accession Number: 20121031–5097. South) to be effective 10/12/2012. Description: Cancellation of Tariff to Comments Due: 5 p.m. e.t. 11/30/12. Filed Date: 10/31/12. be effective 11/1/2012. Docket Numbers: ER13–234–000. Accession Number: 20121031–5117. Filed Date: 10/31/12. Applicants: Kentucky Power Comments Due: 5 p.m. e.t. 11/21/12. Accession Number: 20121031–5218. Comments Due: 5 p.m. e.t. 11/21/12. Company. Docket Numbers: ER13–242–000. Description: Power Coordination Applicants: Midwest Independent Docket Numbers: ER13–251–000. Agreement and Bridge Agreement Transmission System Operator, Inc. Applicants: Arizona Public Service Concurrence to be effective 1/1/2014. Description: SA 2013 G586 Amended Company. Description: APS Service Agreement Filed Date: 10/31/12. GIA to be effective 11/1/2012. No. 327-Azusa Simultaneous Exchange Accession Number: 20121031–5098. Filed Date: 10/31/12. Comments Due: 5 p.m. e.t. 11/30/12. Accession Number: 20121031–5118. to be effective 1/1/2013. Filed Date: 10/31/12. Comments Due: 5 p.m. e.t. 11/21/12. Docket Numbers: ER13–235–000. Accession Number: 20121031–5222. Applicants: Indiana Michigan Power Docket Numbers: ER13–243–000. Comments Due: 5 p.m. e.t. 11/21/12. Company. Applicants: PJM Interconnection, Docket Numbers: ER13–252–000. Description: Power Coordination L.L.C. Applicants: Entergy Gulf States Agreement and Bridge Agreement Description: Original SA No. 3411; Louisiana, L.L.C. Concurrence to be effective 1/1/2014. Queue No. W4–029 & Y1–075 (Reeves Description: EGSL–SRMPA Extension Filed Date: 10/31/12. North) to be effective 10/12/2012. of Interim Agreement to be effective 1/ Accession Number: 20121031–5101. Filed Date: 10/31/12. 1/2013. Comments Due: 5 p.m. e.t. 11/30/12. Accession Number: 20121031–5123. Filed Date: 10/31/12. Docket Numbers: ER13–236–000. Comments Due: 5 p.m. e.t. 11/21/12. Accession Number: 20121031–5229. Applicants: AEP Generation Docket Numbers: ER13–244–000. Comments Due: 5 p.m. e.t. 11/21/12. Resources Inc. Applicants: Green Mountain Power Docket Numbers: ER13–253–000. Description: Bridge Agreement Corporation. Applicants: Entergy Arkansas, Inc. Concurrence to be effective 1/1/2014. Description: Notice of Succession and Description: EAI Filing of Unexecuted Filed Date: 10/31/12. Establishment of New eTariff Database Reimbursement Agreement with AECC Accession Number: 20121031–5104. to be effective 10/31/2012. to be effective 1/1/2013.

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Filed Date: 10/31/12. Filed Date: 10/31/12. Description: Application under Accession Number: 20121031–5235. Accession Number: 20121031–5273. Section 204 of the Federal Power Act for Comments Due: 5 p.m. e.t. 11/21/12. Comments Due: 5 p.m. e.t. 11/21/12. Authorization to Issue Debt Securities of Docket Numbers: ER13–254–000. Docket Numbers: ER13–262–000. ITC Arkansas LLC, ITC Louisiana LLC, Applicants: Midwest Independent Applicants: Central Maine Power ITC Mississippi LLC and ITC Texas Transmission System Operator, Inc. Company. LLC. Description: 10–31–12 ATC Description: Warren Interconnection Filed Date: 10/31/12. Attachment FF to be effective 12/30/ Agreement to be effective 11/1/2012. Accession Number: 20121031–5386. 2012. Filed Date: 10/31/12. Comments Due: 5 p.m. e.t. 11/21/12. Filed Date: 10/31/12. Accession Number: 20121031–5277. Docket Numbers: ES13–6–000. Accession Number: 20121031–5243. Comments Due: 5 p.m. e.t. 11/21/12. Applicants: Entergy Services, Inc., Comments Due: 5 p.m. e.t. 11/21/12. Docket Numbers: ER13–263–000. Transmission Company Arkansas, LLC, Docket Numbers: ER13–255–000. Applicants: Midwest Independent Transmission Company Louisiana I, Applicants: NV Energy, Inc. Transmission System Operator, Inc. LLC, Transmission Company Louisiana Description: Transmission Rate Description: 10–31–12 to be effective II, LLC, Transmission Company Case—NPC to be effective 1/1/2013. 1/1/2013. Mississippi, LLC, Transmission Filed Date: 10/31/12. Filed Date: 10/31/12. Company New Orleans, LLC, Accession Number: 20121031–5246. Accession Number: 20121031–5279. Transmission Company Texas, LLC. Comments Due: 5 p.m. e.t. 11/21/12. Comments Due: 5 p.m. e.t. 11/21/12. Description: Application under Section 204 of the Federal Power Act for Docket Numbers: ER13–256–000. Docket Numbers: ER13–264–000. Applicants: Oklahoma Gas and Authorization to Issue Debt Securities of Applicants: Exelon Energy Company. Electric Company. Description: Exelon Energy Company, Transmission Company Arkansas, LLC, Description: Revisions to Formula Notice of Cancellation to be effective 11/ et al. Rate to be effective 8/2/2012. Filed Date: 10/31/12. 1/2012. Filed Date: 10/31/12. Accession Number: 20121031–5390. Filed Date: 10/31/12. Accession Number: 20121031–5280. Comments Due: 5 p.m. e.t. 11/21/12. Accession Number: 20121031–5250. Comments Due: 5 p.m. e.t. 11/21/12. Comments Due: 5 p.m. e.t. 11/21/12. Take notice that the Commission Docket Numbers: ER13–265–000. received the following land acquisition Docket Numbers: ER13–257–000. Applicants: Nevada Power Company. reports: Applicants: PJM Interconnection, Description: Rate Schedule No. 134 L.L.C. Docket Numbers: LA12–3–000. Interim Balancing Area Services Applicants: Ashtabula Wind, LLC, Description: Queue Position V2–028; Agreement-VEA to be effective 11/1/ Original Service Agreement No. 3413 to Ashtabula Wind II, LLC, Ashtabula 2012. Wind III, LLC, Backbone Mountain be effective 9/28/2012. Filed Date: 10/31/12. Filed Date: 10/31/12. Windpower LLC, Badger Windpower, Accession Number: 20121031–5281. LLC, Baldwin Wind, LLC, Bayswater Accession Number: 20121031–5251. Comments Due: 5 p.m. e.t. 11/21/12. Comments Due: 5 p.m. e.t. 11/21/12. Peaking Facility, LLC, Blackwell Wind, Docket Numbers: ER13–267–000. LLC, Butler Ridge Wind Energy Center, Docket Numbers: ER13–258–000. Applicants: Northern States Power LLC, Crystal Lake Wind, LLC, Crystal Applicants: California Independent Company, a Minnesota corporation, Lake Wind II, LLC, Crystal Lake Wind System Operator Corporation. Northern States Power Company, a III, LLC, Day County Wind, LLC, Diablo Description: 2012–10–31 CAISO Wisconsin corporation. Winds, LLC, Elk City Wind, LLC, Elk Amendment 7 to the PLA with CDWR Description: Northern States Power City II Wind, LLC, Ensign Wind, LLC, to be effective 11/1/2012. Company, a Minnesota corporation, et ESI Vansycle Partners, L.P., Florida Filed Date: 10/31/12. al. submit a Notice of Cancellation of Power & Light Co., FPL Energy Burleigh Accession Number: 20121031–5255. the Restated Electric Service Agreement County Wind, LLC, FPL Energy Cabazon Comments Due: 5 p.m. e.t. 11/21/12. with Rice Lake, Wisconsin. Wind, LLC, FPL Energy Cape, LLC, FPL Docket Numbers: ER13–259–000. Filed Date: 10/31/12. Energy Cowboy Wind, LLC, FPL Energy Applicants: Oklahoma Gas and Accession Number: 20121031–5366. Green Power Wind, LLC, FPL Energy Electric Company. Comments Due: 5 p.m. e.t. 11/21/12. Hancock County Wind, LLC, FPL Description: Revisions to Depreciation Docket Numbers: ER13–268–000. Energy Illinois Wind, LLC, FPL Energy Rates to be effective 8/2/2012. Applicants: Northern States Power Maine Hydro LLC, FPL Energy Marcus Filed Date: 10/31/12. Company, a Wisconsin corporation. Hook, L.P., FPL Energy MH50 L.P., FPL Accession Number: 20121031–5256. Description: Northern States Power Energy Montezuma Wind, LLC, FPL Comments Due: 5 p.m. e.t. 11/21/12. Company, a Wisconsin corporation Energy Mower County, LLC, FPL Energy Docket Numbers: ER13–260–000. submits a Notice of Cancellation of the New Mexico Wind, LLC, FPL Energy Applicants: Dynegy Oakland, LLC. Restated Interconnection and Power and North Dakota Wind, LLC, FPL Energy Description: Annual RMR Section 205 Energy Supply Agreement with the North Dakota Wind II, LLC, FPL Energy Filing and RMR Schedule F Village of Bangor, Wisconsin. Oklahoma Wind, LLC, FPL Energy Informational Filing to be effective 1/1/ Filed Date: 10/31/12. Oliver Wind I, LLC, FPL Energy Oliver 2013. Accession Number: 20121031–5391. Wind II, LLC, FPL Energy Sooner Wind, Filed Date: 10/31/12. Comments Due: 5 p.m. e.t. 11/21/12. LLC, FPL Energy South Dakota Wind, Accession Number: 20121031–5260. Take notice that the Commission LLC, FPL Energy Stateline II, Inc., FPL Comments Due: 5 p.m. e.t. 11/21/12. received the following electric securities Energy Vansycle, LLC, FPL Energy Docket Numbers: ER13–261–000. filings: Wyman, LLC, FPL Energy Wyman IV, Applicants: California Power Docket Numbers: ES13–5–000. LLC, FPL Energy Wyoming, LLC, Exchange Corporation. Applicants: ITC Arkansas LLC, ITC Garden Wind, LLC, Gray County Wind Description: Rate Filing for Rate Louisiana LLC, ITC Mississippi LLC, Energy, LLC, Hatch Solar Energy Center Period 22 to be effective 1/1/2013. ITC Texas LLC. I, LLC, Hawkeye Power Partners, LLC,

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High Majestic Wind Energy Center, LLC, Dated: November 1, 2012. Dated: November 2, 2012. High Winds, LLC, High Majestic Wind Nathaniel J. Davis, Sr., Kimberly D. Bose, II, LLC, Jamaica Bay Peaking Facility, Deputy Secretary. Secretary. LLC, Lake Benton Power Partners II, [FR Doc. 2012–27387 Filed 11–8–12; 8:45 am] [FR Doc. 2012–27408 Filed 11–8–12; 8:45 am] LLC, Langdon Wind, LLC, Limon Wind, BILLING CODE 6717–01–P BILLING CODE 6717–01–P LLC, Limon Wind II, LLC, Logan Wind Energy LLC, Meyersdale Windpower LLC, Mill Run Windpower, LLC, Minco DEPARTMENT OF ENERGY DEPARTMENT OF ENERGY Wind, LLC, Minco Wind II, LLC, Minco Federal Energy Regulatory Federal Energy Regulatory Wind III, LLC, Minco Wind Commission Commission Interconnection Services, LLC, NEPM II, LLC, NextEra Energy Duane Arnold, [Project No. 12965–002] [Docket No. ER13–311–000] LLC, NextEra Energy Montezuma II Wickiup Hydro Group, LLC, Oregon; MP2 Energy IL LLC; Supplemental Wind, LLC, NextEra Energy Power Notice of Availability of Environmental Notice That Initial Market-Based Rate Marketing, LLC, NextEra Energy Point Assessment Filing Includes Request for Blanket Beach, LLC, NextEra Energy Seabrook, Section 204 Authorization LLC, NextEra Energy Services In accordance with the National Massachusetts, LLC, Northeast Energy Environmental Policy Act of 1969 and This is a supplemental notice in the Associates, A Limited Partnership, the Federal Energy Regulatory above-referenced proceeding of MP2 North Jersey Energy Associates, A Commission’s (Commission or FERC’s) Energy IL LLC’s application for market- Limited Partnership, North Sky River regulations, 18 Code of Federal based rate authority, with an Energy, LLC, Northern Colorado Wind Regulations (CFR) Part 380 (Order No. accompanying rate tariff, noting that Energy, LLC, Osceola Windpower, LLC, 486, 52 FR 47897), the Office of Energy such application includes a request for Osceola Windpower II, LLC, Paradise Projects has reviewed Wickiup Hydro blanket authorization, under 18 CFR Solar Urban Renewal, L.L.C., Peetz Group, LLC’s application for an original part 34, of future issuances of securities Table Wind Energy, LLC, Pennsylvania license for the Wickiup Dam and assumptions of liability. Windfarms, Inc., Perrin Ranch Wind, Hydroelectric Project (FERC Project No. Any person desiring to intervene or to LLC, Red Mesa Wind, LLC, Sky River 12965–002), which would be protest should file with the Federal LLC, Somerset Windpower, LLC, Story constructed at the existing Bureau of Energy Regulatory Commission, 888 Wind, LLC, Tuscola Bay Wind, LLC, Reclamation Wickiup Dam on the First Street NE., Washington, DC 20426, Deschutes River in Deschutes County Vasco Winds, LLC, Victory Garden in accordance with Rules 211 and 214 near the city of La Pine, Oregon. The of the Commission’s Rules of Practice Phase IV, LLC, Waymart Wind Farm, proposed project, if licensed, would and Procedure (18 CFR 385.211 and L.P., Wessington Wind Energy Center, occupy 1.02 acres of federal lands 385.214). Anyone filing a motion to LLC, White Oak Energy LLC, Wilton jointly managed by the U.S. Department intervene or protest must serve a copy Wind II, LLC, Windpower Partners of the Interior, Bureau of Reclamation, of that document on the Applicant. 1993, L.P. and the U.S. Forest Service. Notice is hereby given that the Description: Quarterly Land The final environmental assessment deadline for filing protests with regard Acquisition Report of the NextEra (EA) contains staff’s analysis of the to the applicant’s request for blanket Energy Companies. potential environmental effects of authorization, under 18 CFR part 34, of Filed Date: 10/31/12. licensing the project and concludes that future issuances of securities and licensing the project, with appropriate assumptions of liability, is November Accession Number: 20121031–5385. environmental protective measures, 26, 2012. Comments Due: 5 p.m. e.t. 11/21/12. would not constitute a major federal The Commission encourages action that would significantly affect the electronic submission of protests and The filings are accessible in the quality of the human environment. interventions in lieu of paper, using the Commission’s eLibrary system by A copy of the final EA is available for FERC Online links at http://www.ferc. clicking on the links or querying the review at the Commission in the Public gov. To facilitate electronic service, docket number. Reference Room or may be viewed on persons with Internet access who will Any person desiring to intervene or the Commission’s web site at eFile a document and/or be listed as a protest in any of the above proceedings www.ferc.gov using the ‘‘eLibrary’’ link. contact for an intervenor must create must file in accordance with Rules 211 Enter the docket number excluding the and validate an eRegistration account and 214 of the Commission’s last three digits in the docket number using the eRegistration link. Select the Regulations (18 CFR 385.211 and field to access the document. For eFiling link to log on and submit the 385.214) on or before 5:00 p.m. Eastern assistance, contact FERC Online intervention or protests. time on the specified comment date. Support at FERCOnlineSupport@ Persons unable to file electronically Protests may be considered, but ferc.gov or toll-free at 1–866–208–3676, should submit an original and 14 copies intervention is necessary to become a or for TTY, 202–502–8659. of the intervention or protest to the party to the proceeding. You may also register online at Federal Energy Regulatory Commission, www.ferc.gov/docs-filing/ 888 First Street NE., Washington, DC eFiling is encouraged. More detailed esubscription.asp to be notified via 20426. information relating to filing email of new filings and issuances The filings in the above-referenced requirements, interventions, protests, related to this or other pending projects. proceeding are accessible in the service, and qualifying facilities filings For assistance, contact FERC Online Commission’s eLibrary system by can be found at: http://www.ferc.gov/ Support. clicking on the appropriate link in the docs-filing/efiling/filing-req.pdf. For For further information, contact Matt above list. They are also available for other information, call (866) 208–3676 Cutlip by telephone at 503–552–2762 or review in the Commission’s Public (toll free). For TTY, call (202) 502–8659. by email at [email protected]. Reference Room in Washington, DC.

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There is an eSubscription link on the Federal Energy Regulatory Commission, service, persons with Internet access Web site that enables subscribers to 888 First Street NE., Washington, DC who will eFile a document and/or be receive email notification when a 20426. listed as a contact for an intervenor document is added to a subscribed The filings in the above-referenced must create and validate an docket(s). For assistance with any FERC proceeding are accessible in the eRegistration account using the Online service, please email Commission’s eLibrary system by eRegistration link. Select the eFiling [email protected]. or call clicking on the appropriate link in the link to log on and submit the (866) 208–3676 (toll free). For TTY, call above list. They are also available for intervention or protests. (202) 502–8659. review in the Commission’s Public Persons unable to file electronically Dated: November 5, 2012. Reference Room in Washington, DC. should submit an original and 14 copies Nathaniel J. Davis, Sr., There is an eSubscription link on the of the intervention or protest to the Web site that enables subscribers to Deputy Secretary. Federal Energy Regulatory Commission, receive email notification when a 888 First Street NE., Washington, DC [FR Doc. 2012–27391 Filed 11–8–12; 8:45 am] document is added to a subscribed 20426. BILLING CODE 6717–01–P docket(s). For assistance with any FERC The filings in the above-referenced Online service, please email proceeding are accessible in the [email protected]. or call DEPARTMENT OF ENERGY Commission’s eLibrary system by (866) 208–3676 (toll free). For TTY, call clicking on the appropriate link in the Federal Energy Regulatory (202) 502–8659. above list. They are also available for Commission Dated: November 5, 2012. review in the Commission’s Public Reference Room in Washington, DC. [Docket No. ER13–291–000] Nathaniel J. Davis, Sr., Deputy Secretary. There is an eSubscription link on the web site that enables subscribers to EnergyMark, LLC; Supplemental [FR Doc. 2012–27389 Filed 11–8–12; 8:45 am] receive email notification when a Notice that Initial Market-Based Rate BILLING CODE 6717–01–P Filing Includes Request for Blanket document is added to a subscribed Section 204 Authorization docket(s). For assistance with any FERC DEPARTMENT OF ENERGY Online service, please email This is a supplemental notice in the [email protected], or call above-referenced proceeding of Federal Energy Regulatory (866) 208–3676 (toll free). For TTY, call EnergyMark, LLC’s application for Commission (202) 502–8659. market-based rate authority, with an [Docket No. ER13–310–000] Dated: November 5, 2012. accompanying rate tariff, noting that Nathaniel J. Davis, Sr., such application includes a request for MP2 Energy NJ LLC; Supplemental Deputy Secretary. blanket authorization, under 18 CFR Notice that Initial Market-Based Rate [FR Doc. 2012–27390 Filed 11–8–12; 8:45 am] part 34, of future issuances of securities Filing Includes Request for Blanket BILLING CODE 6717–01–P and assumptions of liability. Section 204 Authorization Any person desiring to intervene or to protest should file with the Federal This is a supplemental notice in the DEPARTMENT OF ENERGY Energy Regulatory Commission, 888 above-referenced proceeding of MP2 First Street NE., Washington, DC 20426, Energy NJ LLC’s application for market- Federal Energy Regulatory in accordance with Rules 211 and 214 based rate authority, with an Commission of the Commission’s Rules of Practice accompanying rate tariff, noting that such application includes a request for and Procedure (18 CFR 385.211 and [Project No. 13511–001] 385.214). Anyone filing a motion to blanket authorization, under 18 CFR intervene or protest must serve a copy part 34, of future issuances of securities Igiugig Village Council; Notice of of that document on the Applicant. and assumptions of liability. Successive Preliminary Permit Notice is hereby given that the Any person desiring to intervene or to Application Accepted for Filing and deadline for filing protests with regard protest should file with the Federal Soliciting Comments, Motions To to the applicant’s request for blanket Energy Regulatory Commission, 888 Intervene, and Competing Applications authorization, under 18 CFR part 34, of First Street NE., Washington, DC 20426, future issuances of securities and in accordance with Rules 211 and 214 On October 1, 2012, Igiugig Village assumptions of liability, is November of the Commission’s Rules of Practice Council (IVC) filed an application for a 26, 2012. and Procedure (18 CFR 385.211 and successive preliminary permit, pursuant The Commission encourages 385.214). Anyone filing a motion to to section 4(f) of the Federal Power Act, electronic submission of protests and intervene or protest must serve a copy proposing to study the feasibility of the interventions in lieu of paper, using the of that document on the Applicant. Igiugig RISEC Water Power Project FERC Online links at http://www.ferc. Notice is hereby given that the (Igiugig Project or project), to be located gov. To facilitate electronic service, deadline for filing protests with regard on the Kvichak River in the Lake and persons with Internet access who will to the applicant’s request for blanket Peninsula Borough, Alaska. The sole eFile a document and/or be listed as a authorization, under 18 CFR part 34, of purpose of a preliminary permit, if contact for an intervenor must create future issuances of securities and issued, is to grant the permit holder and validate an eRegistration account assumptions of liability, is November priority to file a license application using the eRegistration link. Select the 26, 2012. during the permit term. A preliminary eFiling link to log on and submit the The Commission encourages permit does not authorize the permit intervention or protests. electronic submission of protests and holder to perform any land disturbing Persons unable to file electronically interventions in lieu of paper, using the activities or otherwise enter upon lands should submit an original and 14 copies FERC Online links at http:// or waters owned by others without the of the intervention or protest to the www.ferc.gov. To facilitate electronic owners’ express permission.

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The proposed project would consist of ENVIRONMENTAL PROTECTION consider to be CBI or otherwise the following: (1) Up to 8 proposed AGENCY protected through www.regulations.gov RISEC kinetic energy-to-electrical or email. The www.regulations.gov Web [EPA–HQ–ORD–2010–0674; FRL–9750–8] energy conversion devices having a total site is an ‘‘anonymous access’’ system, installed capacity of 40 kilowatts; (2) a Request for Information To Inform which means the EPA will not know proposed transmission line that will Hydraulic Fracturing Research Related your identity or contact information either connect directly to the IVC diesel to Drinking Water Resources unless you provide it in the body of power plant or a 1,000-foot-long your comment. If you send an email transmission line interconnecting with AGENCY: Environmental Protection comment directly to the EPA without the Iguigig Village electric distribution Agency (EPA). going through www.regulations.gov, system (depending on the location of ACTION: Request for information. your email address will be the RISEC devices); and (3) appurtenant automatically captured and included as facilities. The proposed project would SUMMARY: EPA is inviting the public to part of the comment that is placed in the have an estimated average annual submit data and scientific literature to public docket and made available on the generation of 250 megawatt-hours. inform EPA’s research on the potential Internet. If you submit information Applicant Contact: AlexAnna impacts of hydraulic fracturing on electronically, EPA recommends that Salmon, Iguigig Village Administrator, drinking water resources. you include your name and other P.O. Box 4008, Iguigig, AK 99613; DATES: EPA will accept data and contact information in the body of your phone: (907) 533–3211. literature in response to this request comment and with any disk or CD–ROM FERC Contact: Jennifer Harper; until April 30, 2013. phone: (202) 502–6136. you submit. If EPA cannot read your ADDRESSES: Deadline for filing comments, motions Using the online method is comment due to technical difficulties to intervene, competing applications preferred for submitting information. and cannot contact you for clarification, (without notices of intent), or notices of Follow the online instructions at EPA may not be able to consider your intent to file competing applications: 60 http://www.regulations.gov, and identify comment. Electronic files should avoid days from the issuance of this notice. your submission with Docket ID No. the use of special characters, any form Competing applications and notices of EPA–HQ–ORD–2010–0674. of encryption, and be free of any defects intent must meet the requirements of 18 Additional methods for submission or viruses. Information on a CD ROM CFR 4.36. Comments, motions to are: should be formatted as a MS Word, Rich • Email: Send information by intervene, notices of intent, and Text or Adobe Acrobat PDF file. For electronic mail (email) to: ord.docket@ competing applications may be filed additional information about EPA’s epa.gov, Attention Docket ID No. EPA– electronically via the Internet. See 18 public docket visit the EPA Docket HQ–ORD–2010–0674. CFR 385.2001(a)(1)(iii) and the Center homepage at http://www.epa. • Fax: Fax information to: (202) 566– instructions on the Commission’s Web gov/dockets. 9744, Attention Docket ID No. EPA– site http://www.ferc.gov/docs-filing/ HQ–ORD–2010–0674. Docket: All documents in the docket efiling.asp. Commenters can submit • Mail: Send information by mail to: are listed in the www.regulations.gov brief comments up to 6,000 characters, U.S. Environmental Protection Agency, index. Although listed in the index, without prior registration, using the EPA Docket Center, Mail Code: 28221T, some information is not publicly eComment system at http:// 1200 Constitution Ave. NW., available, e.g., CBI or other information www.ferc.gov/docs-filing/ Washington, DC 20460, Attention whose disclosure is restricted by statute. ecomment.asp. You must include your Docket ID No. EPA–HQ–ORD–2010– Certain other material, such as name and contact information at the end 0674. copyrighted material, will be publicly of your comments. For assistance, • Hand Delivery or Courier: Deliver available only in hard copy. Publicly please contact FERC Online Support at information to: EPA Docket Center, EPA available docket materials are available [email protected] or toll West Building, Room 3334, 1301 either electronically in www.regulations. free at 1–866–208–3676, or for TTY, Constitution Ave. NW., Washington, gov or in hard copy at EPA Docket (202) 502–8659. Although the DC, Attention Docket ID No. EPA–HQ– Center, EPA West Building, Room 3334, Commission strongly encourages ORD–2010–0674. Deliveries are only 1301 Constitution Ave. NW., electronic filing, documents may also be accepted during the docket’s normal Washington, DC. The Public Reading paper-filed. To paper-file, mail an hours of operation, between 8:30 a.m. Room is open from 8:30 a.m. to 4:30 original and seven copies to: Kimberly and 4:30 p.m. (Eastern), Monday p.m. (Eastern), Monday through Friday, D. Bose, Secretary, Federal Energy through Friday, excluding legal excluding legal holidays. The telephone Regulatory Commission, 888 First Street holidays. Special arrangements should number for the Public Reading Room is NE., Washington, DC 20426. (202) 566–1744, and the telephone More information about this project, be made for deliveries of boxed number for the ORD Docket is (202) including a copy of the application, can information. 566–1752. be viewed or printed on the ‘‘eLibrary’’ Instructions: Direct your information link of Commission’s Web site at to Docket ID No. EPA–HQ–ORD–2010– FOR FURTHER INFORMATION CONTACT: For http://www.ferc.gov/docs-filing/ 0674. EPA’s policy is that all further information contact Lisa elibrary.asp. Enter the docket number information received will be included in Matthews, Mail Code 8101R, Office of (P–13511) in the docket number field to the public docket without change and Research and Development, U.S. access the document. For assistance, may be made available online at www. Environmental Protection Agency, 1200 contact FERC Online Support. regulations.gov, including any personal Pennsylvania Ave. NW., Washington, information provided, unless the DC 20460; via phone/voice mail at: Dated: November 5, 2012. comment includes information claimed (202) 564–6669; via fax at: (202) 565– Kimberly D. Bose, to be Confidential Business Information 2430; or via email at: matthews. Secretary. (CBI) or other information whose [email protected]. [FR Doc. 2012–27409 Filed 11–8–12; 8:45 am] disclosure is restricted by statute. Do BILLING CODE 6717–01–P not submit information that you SUPPLEMENTARY INFORMATION:

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Background 564–7146 or http://www.epa.gov/ Transmission Line Project and Draft In response to public concern, the compliance/nepa/. Resource Management Plan Amendment, Maricopa County, AZ, U.S. Congress urged EPA to conduct Weekly Receipt of Environmental Comment Period Ends: 02/08/2013, scientific research to examine the Impact Statements relationship between hydraulic Contact: Joe Incardine 801–560–7135. Filed 10/29/2012 Through 11/02/2012 fracturing and drinking water resources. EIS No. 20120357, Final Supplement, Pursuant to 40 CFR 1506.9. EPA is undertaking a study to USFWS, CA, Translocation of understand the potential impacts of Notice Southern Sea Otters (Enhydra lutris hydraulic fracturing on drinking water nereis) Program, New and Updated Section 309(a) of the Clean Air Act Information, Santa Barbara, Ventura, resources, if any, and to identify the requires that EPA make public its driving factors that may affect the Los Angeles, Orange, and San Diego comments on EISs issued by other Counties, CA, Review Period Ends: severity and frequency of such impacts. Federal agencies. EPA’s comment letters 12/10/2012, Contact: Lilian Carswell The scope of the study includes the on EISs are available at: http:// 805–644–1766. full hydraulic fracturing water www.epa.gov/compliance/nepa/ EIS No. 20120358, Draft Supplement, lifecycle—from water acquisition, eisdata.html. through the mixing of chemicals and BOEM, 00, Gulf of Mexico Outer injection of fracturing fluids, to the post- SUPPLEMENTARY INFORMATION: As of Continental Shelf (OCS) Oil and Gas fracturing stage, including the October 1, 2012, EPA will not accept Lease Sales: 2013–2014 Western management of flowback and produced paper copies or CDs of EISs for filing Planning Area Lease Sales 233: water and its ultimate treatment and purposes; all submissions on or after Central Planning Area Lease Sales disposal. The study will include a October 1, 2012 must be made through 231, Comment Period Ends: 12/24/ review of the published literature, e-NEPA. 2012, Contact: Gary D. Goeke 504– While this system eliminates the need analysis of existing data, scenario 736–3233. to submit paper or CD copies to EPA to evaluation and modeling, laboratory EIS No. 20120359, Final EIS, USACE, meet filing requirements, electronic studies and case studies. CA, Clearwater Program, Master submission does not change To ensure that EPA is up-to-date on Facilities Plan, To Meet the requirements for distribution of EISs for evolving hydraulic fracturing practices Wastewater Management Needs of the public review and comment. To begin and technologies, EPA is soliciting Joint Outfall System (JOS) Through using e-NEPA, you must first register public involvement in identifying the Year 2050, Los Angeles County, with EPA’s electronic reporting site— relevant data and scientific literature CA, Review Period Ends: 12/10/2012, https://cdx.epa.gov/epa_home.asp. specific to inform EPA’s research study Contact: Aaron O. Allen 805–585– on the potential impacts of hydraulic EIS No. 20120352, Final EIS, USFS, UT, 2148. fracturing on drinking water resources. Chicken Creek Gypsum Mine, EIS No. 20120360, Final EIS, BLM, 00, While EPA conducts a thorough Proposed Plan of Operations to PROGRAMMATIC—Allocation of Oil literature search, there may be studies or Conduct Mining Operations, San Shale and Tar Sands Resources on other primary technical sources that are Pitch Mountains, Sanpete Ranger Lands Administered, Propose to not available through the open District, Manti-La Sal National Forest, Amend 10 Land Use Plans in literature. EPA would appreciate Juab County, UT, Review Period Ends: Colorado, Utah, and Wyoming, 12/10/2012, Contact: Karl Boyer 435– receiving information from the public to Review Period Ends: 12/10/2012, 637–2817. help inform current and future research Contact: Sherri Thompson 303–239– EIS No. 20120353, Final EIS, FHWA, IL, 3758. and ensure a robust record of scientific TIER 2—Elgin O’Hare—West Bypass, information. Consistent with our Extending the Planning Period from Amended Notices commitment to using the highest quality 2030 to 2040, Federal Approvals and information, EPA prefers information EIS No. 20120294, Draft EIS, USN, OR, Funding, Cook and DuPage Counties, Naval Weapons Systems Training which has been peer reviewed. IL, Review Period Ends: 12/10/2012, Interested persons may provide Facility Boardman, Military Readiness Contact: Norman Stoner 217–492– Activities, OR, Comment Period Ends: scientific analyses, studies and other 4600 The U.S. Department of pertinent scientific information. EPA 12/06/2012, Contact: Amy Burt 360– Transportation’s Federal Highway 396–0924. will consider all submissions but will Administration and Federal Aviation give preference to peer reviewed data Administration are joint lead agencies Dated: November 6, 2012. and literature sources. for this project. Cliff Rader, Dated: November 5, 2012. EIS No. 20120354, Draft EIS, FRA, 00, Director, NEPA Compliance Division, Office E. Ramona Trovato, Chicago to Council Bluffs—Omaha of Federal Activities, Associate Assistant Administrator, Office of Regional Passenger Rail System [FR Doc. 2012–27404 Filed 11–8–12; 8:45 am] Research and Development. Planning Study Tier 1 Service Level, BILLING CODE 6560–50–P [FR Doc. 2012–27452 Filed 11–8–12; 8:45 am] from Chicago, Illinois through Iowa BILLING CODE 6560–50–P and Omaha, NE., Comment Period Ends: 12/26/2012, Contact: Andrea Martin 202–493–6201. EXPORT–IMPORT BANK EIS No. 20120355, Final EIS, FRA, 00, ENVIRONMENTAL PROTECTION [Public Notice: 2012–0539] AGENCY Chicago to St. Louis High Speed Rail Program Tier 1, Improvements, [ER–FRL–9005–9] Application for Final Commitment for a Several Counties, IL and St. Louis Long-Term Loan or Financial Environmental Impacts Statements; County, MO, Review Period Ends: 12/ Guarantee in Excess of $100 Million; Notice of Availability 10/2012, Contact: Andrea Martin 202– 25 Day Comment Period 493–6201. Responsible Agency: Office of Federal EIS No. 20120356, Draft EIS, BLM, AZ, AGENCY: Export-Import Bank of the Activities, General Information (202) Sun Valley to Morgan 500/230kV United States.

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ACTION: Notice of 25 day comment consideration of the transaction by the SUMMARY: The Enforcement Bureau (the period regarding an application for final Board of Directors of Ex-Im Bank. ‘‘Bureau’’) gives notice of Ms. Denisa commitment for a long-term loan or ADDRESSES: Comments may be Babcock’s suspension from the schools financial guarantee in excess of $100 submitted through and libraries universal service support million. WWW.REGULATIONS.GOV. mechanism (or ‘‘E-Rate Program’’). Additionally, the Bureau gives notice Reason for Notice: This Notice is to Sharon A. Whitt, that debarment proceedings are inform the public, in accordance with Agency Clearance Officer. commencing against her. Ms. Babcock, Section 3(c)(10) of the Charter of the [FR Doc. 2012–27380 Filed 11–8–12; 8:45 am] or any person who has an existing Export-Import Bank of the United States BILLING CODE 6690–01–P contract with or intends to contract with (‘‘Ex-Im Bank’’), that Ex-Im Bank has her to provide or receive services in received an application for final matters arising out of activities commitment for a long-term loan or EXPORT-IMPORT BANK associated with or related to the schools financial guarantee in excess of $100 and libraries support, may respond by million (as calculated in accordance Sunshine Act Meeting filing an opposition request, supported with Section 3(c)(10) of the Charter). Notice of a Partially Open Meeting of by documentation to Joy Ragsdale, Comments received within the comment Federal Communications Commission, period specified below will be the Board of Directors of the Export- Import Bank of the United States. Enforcement Bureau, Investigations and presented to the Ex-Im Bank Board of Hearings Division, Room 4–C330, 445 Directors prior to final action on this TIME AND PLACE: Monday, November 19, 12th Street SW., Washington, DC 20554. 2012 at 9:30 a.m. The meeting will be Transaction. DATES: Opposition requests must be held at Ex-Im Bank in Room 321, 811 Reference: AP086754XX, received by 30 days from the receipt of Vermont Avenue NW., Washington, DC AP087318XX, and AP087407XX. the suspension letter or December 10, 20571. Purpose and Use: 2012, whichever comes first. The Brief description of the purpose of the OPEN AGENDA ITEMS: Item No. 1: Bureau will decide any opposition transaction: Proposed Economic Impact Procedures request for reversal or modification of To support the export of mining and Methodological Guidelines. suspension or debarment within 90 days trucks and bulldozers to Ukraine. Documentation including the proposed of its receipt of such requests. Brief non-proprietary description of the Economic Impact Procedures and anticipated use of the items being ADDRESSES: Federal Communications Methodological Guidelines as well as Commission, Enforcement Bureau, exported: the public comment can be accessed at To mine iron ore in Ukraine Investigations and Hearings Division, the following location: Room 4–C330, 445 12th Street SW., To the extent that Ex-Im Bank is http://www.exim.gov/ Washington, DC 20554. reasonably aware, the item(s) being generalbankpolicies/economicimpact/ FOR FURTHER INFORMATION CONTACT: Joy exported are not expected to produce proposed-economic-impact- Ragsdale, Federal Communications exports or provide services in procedures.cfm Commission, Enforcement Bureau, competition with the exportation of PUBLIC PARTICIPATION: The meeting will goods or provision of services by a Investigations and Hearings Division, be open to public observation for Item Room 4–C330, 445 12th Street SW., United States industry. No. 1 only. Parties: Washington, DC 20554. Joy Ragsdale Principal Supplier: Caterpillar Inc. FURTHER INFORMATION: The Bank may be contacted by phone at (202) Obligors: OJSC Ferrexpo Poltava requests that members of the public who 418–1697 or email at Mining, Ukraine; OJSC Ferrexpo wish to attend the meeting call Joyce [email protected]. If Ms. Ragsdale is Yeristovo Mining, Ukraine; OJSC Stone, Office of the Secretary, 811 unavailable, you may contact Ms. Ferrexpo Belanovo Mining, Ukraine. Vermont Avenue NW., Washington, DC Theresa Cavanaugh, Chief, Guarantor(s): Ferrexpo AG, 20571 at (202) 565–3336 by close of Investigations and Hearings Division, by Switzerland. business Wednesday, November 14, telephone at (202) 418–1420 and by Description of Items Being Exported: 2012. email at [email protected]. Caterpillar mining trucks and Lisa V. Terry, SUPPLEMENTARY INFORMATION: The bulldozers. Bureau has suspension and debarment Assistant General Counsel. Information on Decision: Information authority pursuant to 47 CFR 54.8 and on the final decision for this transaction [FR Doc. 2012–27421 Filed 11–7–12; 8:45 am] 47 CFR 0.111(a)(14). Suspension will will be available in the ‘‘Summary BILLING CODE 6690–01–P help to ensure that the party to be Minutes of Meetings of Board of suspended cannot continue to benefit Directors’’ on http://www.exim.gov/ from the schools and libraries articles.cfm/board%20minute. FEDERAL COMMUNICATIONS mechanism pending resolution of the Confidential Information: Please note COMMISSION debarment process. Attached is the that this notice does not include suspension letter, DA 12–1620, which confidential or proprietary business [DA 12–1620] was mailed to Ms. Babcock and released information; information which, if on October 10, 2012. The complete text disclosed, would violate the Trade Notice of Suspension and of the notice of suspension and Secrets Act; or information which Commencement of Proposed initiation of debarment proceedings is would jeopardize jobs in the United Debarment Proceedings; Schools and available for public inspection and States by supplying information that Libraries Universal Service Support copying during regular business hours competitors could use to compete with Mechanism at the FCC Reference Information companies in the United States. AGENCY: Federal Communications Center, Portal II, 445 12th Street SW., DATES: Comments must be received on Commission. Room CY–A257, Washington, DC 20554, or before December 4, 2012 to be In addition, the complete text is ACTION: Notice. assured of consideration before final available on the FCC’s Web site at

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http://www.fcc.gov. The text may also be I. Notice of Suspension Pursuant to § 54.8(b) of the 11 purchased from the Commission’s The Commission has established Commission’s rules, upon your duplicating inspection and copying procedures to prevent persons who have conviction for theft of E-Rate funds, the during regular business hours at the ‘‘defrauded the government or engaged Bureau is required to suspend you from contractor, Best Copy and Printing, Inc., in similar acts through activities participating in any activities associated Portal II, 445 12th Street SW., Room associated with or related to the [E-Rate with or related to the E-Rate program, CY–B420, Washington, DC 20554, program]’’ from receiving the benefits including the receipt of funds or telephone (202) 488–5300 or (800) 378– associated with that program.3 The discounted services through the E-Rate 3160, facsimile (202) 488–5563, or via Commission’s rules are designed to program, or consulting with, assisting, email http://www.bcpiweb.com. ensure that all E-Rate funds are used for or advising applicants or service Federal Communications Commission. their intended purpose.4 providers regarding the E-Rate program.12 Your suspension becomes Dated: October 10, 2012. On May 11, 2011, you pled guilty to effective upon either your receipt of this Theresa Z. Cavanaugh, converting more than $1,000,000 belonging to various school districts for letter or its publication in the Federal Chief, Investigations and Hearings Division, Register, whichever comes first.13 Enforcement Bureau. your personal use from November 2005 5 In accordance with the Commission’s DA 12–1620 through December 2009. That amount included approximately $49,000 in E- suspension and debarment rules, you SENT VIA CERTIFIED MAIL, RETURN Rate checks that had been payable to may contest this suspension or the RECEIPT REQUESTED AND EMAIL school districts you represented through scope of this suspension by filing your E-Rate consulting company, arguments, with any relevant Ms. Denisa Babcock, c/o Leon Fred Camanche Consulting Services (CCS).6 documents, within thirty (30) calendar Spies, Mellon & Spies, 312 E. According to your Plea Agreement, you days of your receipt of this letter or College Street, Suite 216, Iowa City, knowingly deposited E-Rate checks [INSERT DATE 30 DAYS AFTER DATE IA 52240 payable to these school districts into OF PUBLICATION IN THE FEDERAL Re: Notice of Suspension and Initiation your personal bank accounts without REGISTER], whichever comes first.14 of Debarment Proceedings FCC File the authority to do so.7 Along with the Such requests, however, will not No. EB–12–IH–1396 other funds stolen from the various ordinarily be granted.15 The Bureau may Dear Ms. Babcock: The Federal school districts, you used these stolen E- reverse or limit the scope of a Communications Commission Rate funds to help pay off your home suspension only upon a finding of (Commission) has received notice of mortgage, fund retirement plans, and extraordinary circumstances.16 The your conviction, under 18 U.S.C. purchase vehicles, real property, a boat, Bureau will decide any request to 666(a)(1)(A) and (b), for theft of, among travel, and personal items.8 reverse or modify a suspension within other amounts, funds associated with On October 14, 2011, the United ninety (90) calendar days of its receipt the federal schools and libraries States District Court for the Southern of such request.17 universal service support mechanism District of Iowa sentenced you to serve II. Initiation of Debarment Proceedings (E-Rate program).1 Consequently, 64 months in prison followed by a pursuant to 47 CFR 54.8, this letter three-year period of supervised release.9 In addition to requiring your constitutes official notice of your In addition, the court ordered you to immediate suspension from the E-Rate suspension from the E-Rate program. In pay $1,330,215.96 in restitution and a program, your conviction is cause for addition, the Enforcement Bureau $100 special assessment.10 debarment as defined in § 54.8(c) of the 18 (Bureau) hereby notifies you that the Commission’s rules. Therefore, Bureau will commence E-Rate program 3 Second Report and Order, 18 FCC Rcd at 9225, debarment proceedings against you.2 para. 66; Program Management Order, 22 FCC Rcd School District No. 314. Id. at 4. In addition, you at 16387, para. 32. The Commission’s debarment were ordered to forfeit, among other items, E-Rate rules define a ‘‘person’’ as ‘‘[a]ny individual, group checks that FBI agents had seized from your 1 Any further reference in this letter to ‘‘your of individuals, corporation, partnership, residence. Plea Agreement at 6–7. conviction’’ refers to your guilty plea in United association, unit of government or legal entity, 11 47 CFR 54.8(a)(4); see Second Report and States v. Babcock, Criminal Docket No. 3:10–cr– however organized.’’ 47 CFR 54.8(a)(6). Order, 18 FCC Rcd at 9225–27, paras. 67–74. 00074–RP–TJS–1, Plea Agreement (S.D. Iowa, May 4 NEC-Business Network Solutions, Inc., Notice of 12 47 CFR 54.8(a)(1), (d). 11, 2011) (Plea Agreement). Debarment and Order Denying Waiver Petition, 21 13 Second Report and Order, 18 FCC Rcd at 9226, 2 See 47 CFR 0.111 (delegating to the Bureau FCC Rcd 7491, 7493, para. 7 (2006). para. 69; 47 CFR 54.8(e)(1). authority to resolve universal service suspension 5 Plea Agreement at 1, 17–18; see also United 14 47 CFR 54.8(e)(4). and debarment proceedings). The Commission States Attorney’s Office, Southern District of Iowa, 15 adopted debarment rules for the E-Rate program in Id. News, Former Clinton Community School District 16 47 CFR 54.8(f). 2003. See Schools and Libraries Universal Service Employee Pleads Guilty to Theft of Federal Funds, 17 Second Report and Order, 18 FCC Rcd at 9226, Support Mechanism, Second Report and Order and May 11, 2011, at http://www.justice.gov/usao/ias/ para. 70; 47 CFR 54.8(e)(5), (f). Further Notice of Proposed Rulemaking, 18 FCC news/2011/Babcock%20-%20plea%20- 18 Rcd 9202 (2003) (Second Report and Order) %20media%20release%20-%205-10-11.pdf (Press ‘‘Causes for suspension and debarment are (adopting § 54.521 to suspend and debar parties Release). conviction of or civil judgment for attempt or from the E-Rate program). In 2007, the Commission commission of criminal fraud, theft, embezzlement, 6 Plea Agreement at 17. extended the debarment rules to apply to all federal forgery, bribery, falsification or destruction of 7 universal service support mechanisms. Id. records, making false statements, receiving stolen Comprehensive Review of the Universal Service 8 Id. at 18. property, making false claims, obstruction of justice Fund Management, Administration, and Oversight; 9 United States v. Babcock, Criminal Docket No. and other fraud or criminal offense arising out of Federal-State Joint Board on Universal Service; 3:10–cr–00074–RP–TJS–1, Amended Judgment at 2 activities associated with or related to the schools Schools and Libraries Universal Service Support (S.D. Iowa, entered Jan. 23, 2012) (Amended and libraries support mechanism, the high-cost Mechanism; Rural Health Care Support Judgment). support mechanism, the rural healthcare support Mechanism; Lifeline and Link Up; Changes to the 10 Amended Judgment at 4–5. This restitution mechanism, and the low-income support Board of Directors for the National Exchange order includes: $8,061.77 payable to Bement mechanism.’’ 47 CFR. 54.8(c). Associated activities Carrier Association, Inc., Report and Order, 22 FCC Community School District Five; $2,231.28 payable ‘‘include the receipt of funds or discounted services Rcd 16372, 16410–12 (2007) (Program Management to the Chester Area School District; $21,789.40 through [the federal universal service] support Order) (renumbering § 54.521 of the universal payable to the Lena-Winslow School District; mechanisms, or consulting with, assisting, or service debarment rules as § 54.8 and amending $17,933.80 payable to North Boone School District advising applicants or service providers regarding subsections (a)(1), (a)(5), (c), (d), (e)(2)(i), (e)(3), 200; $1,852.03 payable to Oldham Public Library; [the federal universal service] support (e)(4), and (g)). and $4,270.64 payable to West Carroll Community mechanisms.’’ Id. 54.8(a)(1).

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pursuant to § 54.8(b) of the Priority Mail), the response must be sent Parties: United States Maritime Commission’s rules, your conviction to the Federal Communications Alliance, Ltd., on behalf of requires the Bureau to commence Commission, 9300 East Hampton Drive, Management, and the International debarment proceedings against you.19 Capitol Heights, Maryland 20743. If sent Longshoremen’s Association, AFL–CIO. As with the suspension process, you by USPS First Class, Express Mail, or Filing Parties: William M. Spelman, may contest the proposed debarment or Priority Mail, the response should be Esq.; The Lambos Firm; 29 Broadway, the scope of the proposed debarment by addressed to Joy Ragsdale, Attorney 9th Floor; New York, NY 10006 and filing arguments and any relevant Advisor, Investigations and Hearings Andre Mazzola, Esq.; Marrinan & documentation within thirty (30) Division, Enforcement Bureau, Federal Mazzola Mardon, P.C.; 26 Broadway, calendar days of receipt of this letter or Communications Commission, 445 12th 17th Floor; New York, NY 10004. its publication in the Federal Register, Street SW., Room 4–C330, Washington, Synopsis: The amendment extends whichever comes first.20 The Bureau, in DC 20554, with a copy to Theresa Z. the terms and conditions of USMX–ILA the absence of extraordinary Cavanaugh, Chief, Investigations and Master Contract to December 29, 2012, circumstances, will notify you of its Hearings Division, Enforcement Bureau, without any changes by USMX and the decision to debar within ninety (90) Federal Communications Commission, ILA. calendar days of receiving any 445 12th Street SW., Room 4–C330, By Order of the Federal Maritime information you may have filed.21 If the Washington, DC 20554. You shall also Commission. Bureau decides to debar you, its transmit a copy of your response via Dated: November 6, 2012. decision will become effective upon email to Joy M. Ragsdale, Karen V. Gregory, either your receipt of a debarment [email protected] and to Theresa Z. Secretary. notice or publication of the decision in Cavanaugh, [email protected]. [FR Doc. 2012–27392 Filed 11–8–12; 8:45 am] the Federal Register, whichever comes If you have any questions, please BILLING CODE 6730–01–P first.22 contact Ms. Ragsdale via U.S. postal If and when your debarment becomes mail, email, or by telephone at (202) effective, you will be prohibited from 418–1697. You may contact me at (202) participating in activities associated 418–1553 or at the email address noted FEDERAL RESERVE SYSTEM with or related to the E-Rate program for above if Ms. Ragsdale is unavailable. Change in Bank Control Notices; three years from the date of Sincerely yours, Acquisitions of Shares of a Bank or 23 debarment. The Bureau may set a Theresa Z. Cavanaugh, Bank Holding Company longer debarment period or extend an Chief, Investigations and Hearings Division, existing debarment period if necessary Enforcement Bureau The notificants listed below have to protect the public interest.24 cc: Johnnay Schrieber, Universal applied under the Change in Bank Please direct any response, if sent by Service Administrative Company Control Act (12 U.S.C. 1817(j)) and messenger or hand delivery, to Marlene (via email); Rashann Duvall, § 225.41 of the Board’s Regulation Y (12 H. Dortch, Secretary, Federal Universal Service Administrative CFR 225.41) to acquire shares of a bank Communications Commission, 445 12th Company (via email); Maureen or bank holding company. The factors Street SW., Room TW–A325, McGuire, United States Attorney’s that are considered in acting on the Washington, DC 20554 and to the Office, Southern District of Iowa notices are set forth in paragraph 7 of attention of Joy M. Ragsdale, Attorney (via email); Richard Westphal, the Act (12 U.S.C. 1817(j)(7)). Advisor, Investigations and Hearings United States Attorney’s Office, The notices are available for Division, Enforcement Bureau, Room 4– Southern District of Iowa (via immediate inspection at the Federal C330, Federal Communications email) Reserve Bank indicated. The notices also will be available for inspection at Commission, 445 12th Street SW., [FR Doc. 2012–27348 Filed 11–8–12; 8:45 am] Washington, DC 20554 with a copy to the offices of the Board of Governors. BILLING CODE 6712–01–P Theresa Z. Cavanaugh, Division Chief, Interested persons may express their Investigations and Hearings Division, views in writing to the Reserve Bank Enforcement Bureau, Room 4–C330, indicated for that notice or to the offices FEDERAL MARITIME COMMISSION Federal Communications Commission, of the Board of Governors. Comments must be received not later than 445 12th Street SW., Washington, DC Notice of Agreement Filed 20554. All messenger or hand delivery November 27, 2012. filings must be submitted without The Commission hereby gives notice A. Federal Reserve Bank of Kansas envelopes.25 If sent by commercial of the filing of the following agreements City (Dennis Denney, Assistant Vice overnight mail (other than U.S. Postal under the Shipping Act of 1984. President) 1 Memorial Drive, Kansas Service (USPS) Express Mail and Interested parties may submit comments City, Missouri 64198–0001: on the agreements to the Secretary, 1. G. Jeffrey Records, Jr., Oklahoma 19 Id. 54.8(b). Federal Maritime Commission, City, Oklahoma; as trustee, of the 20 Second Report and Order, 18 FCC Rcd at 9226, Washington, DC 20573, within ten days Martha E. Records 2009 GST Exempt para. 70; 47 CFR § 54.8(e)(3). of the date this notice appears in the Family Trust; the Martha E. Records 21 Second Report and Order, 18 FCC Rcd at 9226, Federal Register. Copies of the 2009 Non-Exempt Family Trust; the para. 70; 47 CFR. § 54.8(e)(5). agreements are available through the Kathryn R. Ryan 2007 GST Exempt 22 47 CFR 54.8(e)(5). The Commission may Family Trust; the Kathryn R. Ryan 2007 reverse a debarment, or may limit the scope or Commission’s Web site (www.fmc.gov) period of debarment, upon a finding of or by contacting the Office of Non-Exempt Family Trust; and the extraordinary circumstances, following the filing of Agreements at (202)–523–5793 or George J. and Nancy J. Records 1990 a petition by you or an interested party or upon [email protected]. Irrevocable Trust, all in Oklahoma City, motion by the Commission. Id. 54.8(f). Agreement No.: 201157–002. Oklahoma, to acquire voting shares of 23 Second Report and Order, 18 FCC Rcd at 9225, para. 67; 47 CFR 54.8(d), (g). Title: USMX–ILA Master Contract Midland Financial Co., and thereby 24 47 CFR 54.8(g). between United States Maritime indirectly acquire voting shares of 25 See FCC Public Notice, DA 09–2529 for further Alliance, Ltd. and International MidFirst Bank, both in Oklahoma City, filing instructions (rel. Dec. 3, 2009). Longshoremen’s Association. Oklahoma.

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Board of Governors of the Federal Reserve ‘‘Submit a Comment’’ screen. Please Dated: November 1, 2012. System, November 6, 2012. include your name, company name (if William Clark, Margaret McCloskey Shanks, any), and ‘‘Information Collection 9000– Acting Director, Federal Acquisition Policy Deputy Secretary of the Board. 0088, Travel Costs’’ on your attached Division, Office of Governmentwide [FR Doc. 2012–27411 Filed 11–8–12; 8:45 am] document. Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. BILLING CODE 6210–01–P • Fax: 202–501–4067. • Mail: General Services [FR Doc. 2012–27397 Filed 11–8–12; 8:45 am] Administration, Regulatory Secretariat BILLING CODE 6820–EP–P DEPARTMENT OF DEFENSE (MVCB), 1275 First Street NE., Washington, DC 20417. ATTN: Hada GENERAL SERVICES Flowers/IC 9000–0088, Travel Costs. DEPARTMENT OF DEFENSE ADMINISTRATION Instructions: Please submit comments GENERAL SERVICES only and cite Information Collection ADMINISTRATION NATIONAL AERONAUTICS AND 9000–0088, Travel Costs, in all SPACE ADMINISTRATION correspondence related to this NATIONAL AERONAUTICS AND [Docket 2012–0076; Sequence 34; OMB collection. All comments received will SPACE ADMINISTRATION Control No. 9000–0088] be posted without change to http:// www.regulations.gov, including any [Docket 2012–0076; Sequence 31; OMB Federal Acquisition Regulation; personal and/or business confidential Control No. 9000–0077] Information Collection; Travel Costs information provided. Federal Acquisition Regulation; AGENCY: Department of Defense (DOD), FOR FURTHER INFORMATION CONTACT: Mr. Information Collection; Quality General Services Administration (GSA), Edward Chambers, Procurement Assurance Requirements and National Aeronautics and Space Analyst, Office of Acquisition Policy, AGENCY: Department of Defense (DOD), Administration (NASA). GSA, (202) 501–3221 or via email at [email protected]. General Services Administration (GSA), ACTION: Notice of request for comments and National Aeronautics and Space regarding the extension of a previously A. Purpose Administration (NASA). existing OMB clearance. FAR 31.205–46, Travel Costs, requires ACTION: Notice of request for public SUMMARY: Under the provisions of the that, except in extraordinary and comments regarding an extension to an Paperwork Reduction Act, the temporary situations, costs incurred by existing OMB clearance. a contractor for lodging, meals, and Regulatory Secretariat will be SUMMARY: Under the provisions of the submitting to the Office of Management incidental expenses shall be considered Paperwork Reduction Act, Regulatory and Budget (OMB) a request to review to be reasonable and allowable only to Secretariat will be submitting to the and approve an extension of a the extent that they do not exceed on a Office of Management and Budget previously approved information daily basis the per diem rates in effect (OMB) a request to review and approve collection requirement concerning as of the time of travel as set forth in the an extension of a previously approved Travel Costs. Federal Travel Regulations for travel in information collection requirement Public comments are particularly the conterminous 48 United States, the concerning quality assurance invited on: Whether this collection of Joint Travel Regulations, Volume 2, requirements. information is necessary; whether it will Appendix A, for travel is Alaska, Public comments are particularly have practical utility; whether our Hawaii, the Commonwealth of Puerto invited on: Whether this collection of estimate of the public burden of this Rico, and territories and possessions of information is necessary for the proper collection of information is accurate, the United States, and the Department performance of functions of the Federal and based on valid assumptions and of State Standardized Regulations, Acquisition Regulations (FAR), and methodology; ways to enhance the section 925, ‘‘Maximum Travel Per whether it will have practical utility; quality, utility, and clarity of the Diem Allowances for Foreign Areas.’’ whether our estimate of the public information to be collected; and ways in The burden generated by this coverage burden of this collection of information which we can minimize the burden of is in the form of the contractor is accurate, and based on valid the collection of information on those preparing a justification whenever a assumptions and methodology; ways to who are to respond, through the use of higher actual expense reimbursement enhance the quality, utility, and clarity appropriate technological collection method is used. of the information to be collected; and techniques or other forms of information B. Annual Reporting Burden ways in which we can minimize the technology. burden of the collection of information DATES: Submit comments on or before Respondents: 3,598. on those who are to respond, through January 8, 2013. Responses per Respondent: 10. the use of appropriate technological ADDRESSES: Submit comments Total Responses: 35,980. collection techniques or other forms of identified by Information Collection Hours per response: .25. information technology. 9000–0088, Travel Costs by any of the Total Burden Hours: 8,995. DATES: Submit comments on or before following methods: Obtaining Copies of Proposals: January 8, 2013. • Regulations.gov: http:// Requesters may obtain a copy of the ADDRESSES: Submit comments www.regulations.gov. Submit comments information collection documents from identified by Information Collection via the Federal eRulemaking portal by the General Services Administration, 9000–0077, Quality Assurance searching the OMB control number. Regulatory Secretariat (MVCB), 1275 Requirements, by any of the following Select the link ‘‘Submit a Comment’’ First Street NE., Washington, DC 20417, methods: that corresponds with ‘‘Information telephone (202) 501–4755. Please cite • Regulations.gov: http:// Collection 9000–0088, Travel Costs’’. OMB Control No. 9000–0088, Travel www.regulations.gov. Submit comments Follow the instructions provided at the Costs, in all correspondence. via the Federal eRulemaking portal by

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searching the OMB control number. Responses per Respondent: engage in at least 60 minutes of physical Select the link ‘‘Submit a Comment’’ 1.0186344. activity each day and provides strategies that corresponds with ‘‘Information Total Responses: 179,571. for increasing physical activity in youth Collection 9000–0077, Quality Hours per Response: 82246. toward meeting the PAG. Although the Assurance Requirements’’. Follow the Total Burden Hours: 147,690. PAG did not include specific instructions provided at the ‘‘Submit a Obtaining Copies of Proposals: recommendations for youth younger Comment’’ screen. Please include your Requesters may obtain a copy of the than age 6, the PAG Mid-course Report name, company name (if any), and information collection documents from includes intervention strategies in the ‘‘Information Collection 9000–0077, the General Services Administration, preschool/childcare setting. This is a Quality Assurance Requirements’’ on Regulatory Secretariat (MVCB), 1275 response to new science on physical your attached document. First Street NE., Washington, DC 20417, activity among young children and • Fax: 202–501–4067. telephone (202) 501–4755. Please cite supports HHS’ efforts through Healthy • Mail: General Services OMB Control No. 9000–0077, Quality People 2020 to promote physical Administration, Regulatory Secretariat Assurance Requirements, in all activity in childcare settings. The (MVCB), 1275 First Street NE., correspondence. subcommittee has completed its draft Washington, DC 20417. ATTN: Hada Dated: November 1, 2012. report and is soliciting public comment Flowers/IC 9000–0077, Quality William Clark, before the report is presented to PCFSN for deliberation, and subsequent Assurance Requirements. Acting Director, Federal Acquisition Policy, Instructions: Please submit comments Office of Governmentwide Acquisition Policy, submission to the Secretary, HHS. only and cite Information Collection Office of Acquisition Policy, Office of DATES: Written comments on the PAG 9000–0077, Quality Assurance Governmentwide Policy. Mid-course Report can be submitted by Requirements, in all correspondence [FR Doc. 2012–27399 Filed 11–8–12; 8:45 am] email or mail and must be received on related to this collection. All comments BILLING CODE 6820–EP–P or before December 10, 2012 at 9:00 a.m. received will be posted without change EST. to http://www.regulations.gov, including ADDRESSES: The PAG Mid-course Report any personal and/or business DEPARTMENT OF HEALTH AND is available for review electronically at confidential information provided. HUMAN SERVICES www.health.gov/PAguidelines. FOR FURTHER INFORMATION CONTACT: Mr. Comments may be either emailed to Curtis E. Glover, Sr., Procurement Announcement of Physical Activity [email protected] or Analyst, Contract Policy Division, GSA Guidelines Mid-Course Report mailed to Katrina Butner, Office of (202) 501–1448 or email Availability and Public Comment Disease Prevention and Health [email protected]. Period Promotion, Department of Health and Human Services, 1101 Wootton SUPPLEMENTARY INFORMATION: AGENCY: Office of Disease Prevention Parkway, Suite LL100, Rockville, MD A. Purpose and Health Promotion, Office of the 20852. For those submitting written Assistant Secretary for Health, Office of Supplies and services acquired under comments of more than 5 pages in the Secretary, Department of Health and length, please provide a 1-page Government contracts must conform to Human Services. the contract’s quality and quantity summary of key points related to the ACTION: Notice. requirements. FAR Part 46 prescribes comments submitted. inspection, acceptance, warranty, and FOR FURTHER INFORMATION CONTACT: other measures associated with quality Authority: 15 U.S.C. 3719. Katrina L. Butner, Ph.D., RD, ACSM requirements. Standard clauses related SUMMARY: The U.S. Department of CES, Coordinator, Physical Activity to inspection require the contractor to Health and Human Services (HHS) Guidelines for Americans Mid-course provide and maintain an inspection announces the availability of the Report, Physical Activity and Nutrition system that is acceptable to the Physical Activity Guidelines for Advisor, Office of Disease Prevention Government; give the Government the Americans (PAG) Mid-course Report and Health Promotion, Department of right to make inspections and test while and solicits written comments on the Health and Human Services, 1101 work is in process; and require the draft report. A subcommittee of the Wootton Parkway, LL100, Rockville, contractor to keep complete, and make President’s Council on Fitness, Sports MD 20852. Email: available to the Government, records of and Nutrition (PCFSN) was convened to [email protected]. Phone: (240) its inspection work. The complete the PAG Mid-course Report. 453–8271. The subcommittee was tasked with SUPPLEMENTARY INFORMATION: A B. Annual Reporting Burden reviewing the evidence on intervention subcommittee of the President’s Council An upward adjustment is being made strategies that have been shown to be on Fitness, Sports and Nutrition to the previously approved estimated effective in increasing physical activity (PCFSN) was created with approval of annual burden. The change is based on among youth ages 3–17. The report is a the Secretary, HHS. The subcommittee calculating the burden for each clause in review-of-reviews which highlights is comprised of ten experts in physical FAR Part 46 associated with this research from a variety of settings in activity from both federal and non- information collection requirement. In which physical activity can successfully federal sectors and is chaired by Council addition, the Government considered be implemented for youth, including member, Dr. Risa Lavizzo-Mourey. The the information collected under this school, community, preschool/ PAG Mid-course Report will serve as a requirement to be records kept as a part childcare, home/family, and primary complement to the Physical Activity of a contractor’s normal business care settings. In addition, the report Guidelines for Americans, 2008 and is operations, and the Government will identifies areas for future research. expected to be released in 2013. only request to see the records a limited The intent of this report is to serve as The PAG Mid-course Report is number of times per year for each a complement to the Physical Activity available electronically at contractor. Guidelines for Americans, 2008 which www.health.gov/PAguidelines. Hard Respondents: 176,286. recommends that youth ages 6–17 copies may be obtained by contacting

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the individual named within the FOR DEPARTMENT OF HEALTH AND and interpretive regulations, and other FURTHER INFORMATION CONTACT section of HUMAN SERVICES Federal Register notices that were this notice. published from July through September Centers for Medicare & Medicaid Dated: September 24, 2012. 2012, relating to the Medicare and Services Medicaid programs and other programs Don Wright, [CMS–9075–N] administered by CMS. Director, Office of Disease Prevention and Health Promotion. Medicare and Medicaid Programs; FOR FURTHER INFORMATION CONTACT: It is [FR Doc. 2012–27425 Filed 11–8–12; 8:45 am] Quarterly Listing of Program possible that an interested party may BILLING CODE 4150–32–P Issuances—July through September need specific information and not be 2012 able to determine from the listed information whether the issuance or AGENCY: Centers for Medicare & regulation would fulfill that need. Medicaid Services (CMS), HHS. Consequently, we are providing contact ACTION: Notice. persons to answer general questions SUMMARY: This quarterly notice lists concerning each of the addenda CMS manual instructions, substantive published in this notice.

Addenda Contact Phone No.

I CMS Manual Instructions ...... Ismael Torres ...... (410) 786–1864 II Regulation Documents Published in the Federal Register ...... Terri Plumb ...... (410) 786–4481 III CMS Rulings ...... Tiffany Lafferty ...... (410) 786–7548 IV Medicare National Coverage Determinations ...... Wanda Belle ...... (410) 786–7491 V FDA-Approved Category B IDEs ...... John Manlove ...... (410) 786–6877 VI Collections of Information ...... Mitch Bryman ...... (410) 786–5258 VII Medicare-Approved Carotid Stent Facilities ...... Sarah J. McClain ...... (410) 786–2294 VIII American College of Cardiology-National Cardiovascular Data Registry Sites ...... JoAnna Baldwin, MS ...... (410) 786–7205 IX Medicare’s Active Coverage-Related Guidance Documents ...... Lori Ashby ...... (410) 786–6322 X One-Time Notices Regarding National Coverage Provisions ...... Lori Ashby ...... (410) 786–6322 XI National Oncologic Positron Emission Tomography Registry Sites ...... Stuart Caplan, RN, MAS ...... (410) 786–8564 XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ...... JoAnna Baldwin, MS ...... (410) 786–7205 XIII Medicare-Approved Lung Volume Reduction Surgery Facilities ...... JoAnna Baldwin, MS ...... (410) 786–7205 XIV Medicare-Approved Bariatric Surgery Facilities ...... Kate Tillman, RN, MAS ...... (410) 786–9252 XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ...... Stuart Caplan, RN, MAS ...... (410) 786–8564 All Other Information ...... Annette Brewer ...... (410) 786–6580

I. Background statements necessary to administer and them in accordance with what has been oversee the programs efficiently. learned.’’ This approach is also in Among other things, the Centers for Section 1871(c) of the Act requires alignment with the President’s Open Medicare & Medicaid Services (CMS) is that we publish a list of all Medicare Government and Transparency Initiative responsible for administering the manual instructions, interpretive rules, that establishes a system of Medicare and Medicaid programs and statements of policy, and guidelines of transparency, public participation, and coordination and oversight of private general applicability not issued as collaboration. health insurance. Administration and regulations at least every 3 months in Therefore, this quarterly notice oversight of these programs involves the the Federal Register. provides only the specific updates that following: (1) Furnishing information to have occurred in the 3-month period Medicare and Medicaid beneficiaries, II. Revised Format for the Quarterly Issuance Notices along with a hyperlink to the full listing health care providers, and the public; that is available on the CMS Web site or and (2) maintaining effective While we are publishing the quarterly the appropriate data registries that are communications with CMS regional notice required by section 1871(c) of the used as our resources. This information offices, State governments, State Act, we will no longer republish is the most current up-to-date Medicaid agencies, State survey duplicative information that is available information and will be available earlier agencies, various providers of health to the public elsewhere. We believe this than we publish our quarterly notice. care, all Medicare contractors that approach is in alignment with CMS’ We believe the Web site list provides process claims and pay bills, National commitment to the general principles of more timely access for beneficiaries, Association of Insurance Commissioners the President’s Executive Order 13563 providers, and suppliers. We also (NAIC), health insurers, and other released January 2011entitled believe the Web site offers a more stakeholders. To implement the various ‘‘Improving Regulation and Regulatory convenient tool for the public to find statutes on which the programs are Review,’’ which promotes modifying the full list of qualified providers for based, we issue regulations under the and streamlining an agency’s regulatory these specific services and offers more authority granted to the Secretary of the program to be more effective in flexibility and ‘‘real time’’ accessibility. Department of Health and Human achieving regulatory objectives. Section In addition, many of the Web sites have Services under sections 1102, 1871, 6 of Executive Order 13563 requires listservs; that is, the public can 1902, and related provisions of the agencies to identify regulations that may subscribe and receive immediate Social Security Act (the Act) and Public be ‘‘outmoded, ineffective, insufficient, notification of any updates to the Web Health Service Act. We also issue or excessively burdensome, and to site. These listservs avoid the need to various manuals, memoranda, and modify, streamline, expand or repeal check the Web site, as notification of

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updates is automatic and sent to the covered by the notice to determine Hospital Insurance, Program No. 93.774, subscriber as they occur. If assessing a whether any are of particular interest. Medicare—Supplementary Medical Web site proves to be difficult, the We expect this notice to be used in Insurance Program, and Program No. 93.714, contact person listed can provide concert with previously published Medical Assistance Program) information. notices. Those unfamiliar with a Dated: November 5, 2012. description of our Medicare manuals Kathleen Cantwell, III. How To Use the Notice should view the manuals at http:// www.cms.gov/manuals. Director, Office of Strategic Operations and This notice is organized into 15 Regulatory Affairs. addenda so that a reader may access the Authority: (Catalog of Federal Domestic subjects published during the quarter Assistance Program No. 93.773, Medicare— BILLING CODE 4120–01–P

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VerDate Mar<15>2010 17:34 Nov 08, 2012 Jkt 229001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\09NON1.SGM 09NON1 tkelley on DSK3SPTVN1PROD with NOTICES EN09NO12.011 Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices 67373 a if or on or the in not the also the notice, as code, or Program period. by or, the from has 07/1312012 06/08/2012 Date Effective sections health the of complex questions I payment serve contact of and of appears, or entries below quarterly For NCD. whether Medicare, date 3-month NCDs, that Date Medicare decisions identified private well as to an decisions The for this Determinations the policy as the are coverage Issue 08/03/2012 08/03/2012 of in service, of decision I issue 2012) or information, (410-786-7548). www.cms.gov!medicare­ Review, relating to the under completed pending announce determination service. interpretation Rulings the effective Secretary a at: of national item Coverage or Administrator decisions decisions, Peer purposes occurred and also the and which statements CMS Lafferty the well as the item Number R144NCD R146NCD Transmittal by in additional at have include of September I as nationally website and regulations appropriate which covered or III: For Control National issued, or not completed that our completed not Completed Tiffany covered on clarification was law orders 160.27 Section NCDM 260.1 NCD NCD (NCDM) accessed covered does through was reconsiderations I decisions decisions Quality is it the website. questions be particular and or updates but includes determination contact notice. a are Medicare of matters. memoranda, Addendum a and (July Nerve can provide For to IV /Rulings!CMSRllist.asp#TopOfPage. concerning why Manual available is particular CMS this Act), IV: service for is publication gov Chronic by specific completed the opinions (NCDs), They or related Rulings for a NCD NCD the rulings decision Electrical on on explain the ofthe assigned provisions .cms. and Utilization information, the final item An (TENS) is and The CMS Addendum date Pain covered of BelleJ41O-786-7491). only cases, Addendum posted XVIII the information that Transplantation Back list some section Stimulation This Transcutaneous Information Title additional insurance, interpretation. include information include quarter decision. determinations any, coverage-database!. determination ambiguous (title http://www been program particular precedent we title, Malignancies Wanda Liver Medicaid, Low and The Relate for for 837 present B Including ICD-9 Sensitivity Sensitivity and through the (TCD-IO) to to to They volume and the Edits Edits Part 5010 individual from 2012) Plumb as Edits due due due day the of3) Workload and Federal text AA) 1 Federal A or editions, Terri the database (837P) each (HIP through Reprocurment (CR Systems Published Part both ordering Legacy at: to Prepayment Prepayment daily 5 Conversion Act September a.m. MAC) the WPS printed 1994) Shared contact online 6 (NCDs) InternetlIntranet InternetlIntranet InternetlIntranet When in 2, downloads/Regs- publication an to to to AlB by includes Modeling Modeling MCS Professional (ICD)-IO Website subscribe of as (J5 Services Documents and 837 through our or Medicare the Jurisdiction Remaining posted posted posted editions, Accountability date the on Diseases FISS for (January 5010 the not not updated Predictive Predictive published and database information, of Therapy Determinations 1 of (July the is for copies and Contractor available of are within The Award is Regulation electronic audience not Edits audience, audience, either the available Instruction Prevention Prevention Coverage http://www.gpoaccess.gov/fr/index.html. Number Portability Review (xrefCR7787) (xrefCR7787) Number of is II: of Register www.gpo.gov!fdsys. database additional notices at Infrastructure cite Classification (8371) individual at 59, or access Fraud Fraud specific specific, specific Established Register to Administrative and a a a guarterlyproviderupdates! published. to 2012 National Code Medical Systems Systems Insurance Workload to to to http://www.archives.gov/federal-register/provides online is GPO Field number. Federal Notices gov! accessed Instruction Instruction CMS how New The Volume purchase information Addendum Confidentiality a of of Shared Shared Manual to Health Implement Medicare Related January Issued Implement Issued Institutional Implementation International Issued New None the Federal questions be and on page necessary .cms. in To Website contact copies. is from can Regulations This The For Register and it Access. 786-4481). and 1117 1116 1113 1115 1120 1112 1114 1119 1121 1122 1118 Regulations Register. Register, Federal graphics information date following GPO copies, (410- 3Q12QPU.pdf reference http://www number

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[FR Doc. 2012–27422 Filed 11–08–12; 8:45 am] www.regulations.gov. Submit written not create or confer any rights for or on BILLING CODE 4120–01–C comments to the Division of Dockets any person and does not operate to bind Management (HFA–305), Food and Drug FDA or the public. An alternative Administration, 5630 Fishers Lane, rm. approach may be used if such approach DEPARTMENT OF HEALTH AND 1061, Rockville, MD 20852. Identify satisfies the requirements of the HUMAN SERVICES comments with the docket number applicable statute and regulations. found in brackets in the heading of this Food and Drug Administration document. III. Electronic Access [Docket No. FDA–2012–D–1057] FOR FURTHER INFORMATION CONTACT: John Persons interested in obtaining a copy Hobson, Center for Devices and of the draft guidance may do so by using Draft Guidance for Industry and Food Radiological Health, Food and Drug and Drug Administration Staff; Highly the Internet. A search capability for all Administration, 10903 New Hampshire CDRH guidance documents is available Multiplexed Microbiological/Medical Ave., Bldg. 66, rm. 5555, Silver Spring, at http://www.fda.gov/MedicalDevices/ Countermeasure In Vitro Nucleic Acid MD 20993–0002, 301–796–5892. Based Diagnostic Devices; Availability DeviceRegulationandGuidance/ SUPPLEMENTARY INFORMATION: GuidanceDocuments/default.htm. AGENCY: Food and Drug Administration, Guidance documents are also available HHS. I. Background at http://www.regulations.gov. To ACTION: Notice. This draft guidance is to provide industry and Agency staff with receive ‘‘Highly Multiplexed SUMMARY: The Food and Drug recommendations for studies to Microbiological/Medical Administration (FDA) is announcing the establish the analytical and clinical Countermeasure In Vitro Nucleic Acid availability of the draft guidance performance of HMMDs intended to Based Diagnostic Devices,’’ you may entitled ‘‘Highly Multiplexed simultaneously detect and identify either send an email request to Microbiological/Medical multiple pathogen nucleic acids [email protected] to receive an Countermeasure In Vitro Nucleic Acid extracted from a single appropriate electronic copy of the document or send Based Diagnostic Devices.’’ This draft human specimen or culture. For the a fax request to 301–847–8149 to receive guidance is to provide industry and purposes of this draft guidance a hard copy. Please use the document Agency staff with recommendations for document the multiplex level that is number 1803 to identify the guidance studies to establish the analytical and used to define HMMDs is the capability you are requesting. clinical performance of highly to detect ≥20 different organisms/ IV. Paperwork Reduction Act of 1995 multiplexed microbiological/medical targets, in a single reaction, using a countermeasures in vitro nucleic acid nucleic acid based technology and This draft guidance refers to currently based diagnostic devices (HMMDs) involves testing multiple targets through intended to simultaneously detect and approved collections of information a common process of specimen found in FDA regulations. These identify multiple pathogen nucleic acids preparation, amplification and/or extracted from a single appropriate collections of information are subject to detection, and result interpretation. review by the Office of Management and human specimen or culture. This draft HMMDs are used to aid in the diagnosis Budget (OMB) under the Paperwork guidance is not final nor is it in effect of infection. Reduction Act of 1995 (44 U.S.C. 3501– at this time. The scope of this draft guidance 3520). The collections of information in DATES: Although you can comment on includes nucleic acid based devices that any guidance at any time (see 21 CFR employ technologies such as 21 CFR parts 801 and 809 have been 10.115(g)(5)), to ensure that the Agency polymerase chain reaction, reverse- approved under OMB control number considers your comment on this draft transcriptase polymerase chain reaction, 0910–0485; the collections of guidance before it begins work on the bead-based liquid arrays, microarrays, information in 21 CFR part 807, subpart final version of the guidance, submit re-sequencing approaches as well as the E, have been approved under OMB either electronic or written comments measurement of individual targets control number 0910–0120; and the on the draft guidance by February 7, determined by ≥20 separate assays that collections of information in 21 CFR 2013. are reported out simultaneously through part 820 have been approved under ADDRESSES: Submit written requests for the use of a diagnostic algorithm. This OMB control number 0910–0073. single copies of the draft guidance draft guidance is not intended to V. Comments document entitled ‘‘Highly Multiplexed address devices that utilize detection Microbiological/Medical mechanisms other than nucleic acid Interested persons may submit either Countermeasure In Vitro Nucleic Acid based approaches. The document does written comments regarding this Based Diagnostic Devices’’ to the not apply to devices that are intended document to the Division of Dockets Division of Small Manufacturers, to screen donors of blood and blood Management (see ADDRESSES) or International, and Consumer Assistance, components, and donors of human cells, electronic comments to http:// Center for Devices and Radiological tissues, and cellular and tissue-based www.regulations.gov. It is only Health, Food and Drug Administration, products for communicable diseases. necessary to send one set of comments. 10903 New Hampshire Ave., Bldg. 66, II. Significance of Guidance Identify comments with the docket rm. 4613, Silver Spring, MD 20993– number found in brackets in the 0002. Send one self-addressed adhesive This draft guidance is being issued label to assist that office in processing consistent with FDA’s good guidance heading of this document. Received your request, or fax your request to 301– practices regulation (21 CFR 10.115). comments may be seen in the Division 847–8149. See the SUPPLEMENTARY The draft guidance, when finalized, will of Dockets Management between 9 a.m. INFORMATION section for information on represent the Agency’s current thinking and 4 p.m., Monday through Friday, and electronic access to the guidance. on highly multiplexed microbiological/ will be posted to the docket at http:// Submit electronic comments on the medical countermeasure in vitro nucleic www.regulations.gov. draft guidance to http:// acid based diagnostic devices. It does

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Dated: October 31, 2012. default.htm and scroll down to the accommodated during the scheduled Leslie Kux, appropriate advisory committee meeting open public hearing session, FDA may Assistant Commissioner for Policy. link, or call the advisory committee conduct a lottery to determine the [FR Doc. 2012–27340 Filed 11–8–12; 8:45 am] information line to learn about possible speakers for the scheduled open public BILLING CODE 4160–01–P modifications before coming to the hearing session. The contact person will meeting. notify interested persons regarding their Agenda: The committee will discuss request to speak by November 15, 2012. DEPARTMENT OF HEALTH AND the risks and benefits of new drug Persons attending FDA’s advisory HUMAN SERVICES application (NDA) 202880, by Zogenix committee meetings are advised that the Inc., for hydrocodone bitartrate Agency is not responsible for providing Food and Drug Administration extended-release capsules (proposed access to electrical outlets. tradename ZOHYDRO ER), an opioid FDA welcomes the attendance of the [Docket No. FDA–2012–N–0001] analgesic medication for the public at its advisory committee Anesthetic and Analgesic Drug management of moderate to severe meetings and will make every effort to Products Advisory Committee; Notice chronic pain when a continuous, accommodate persons with physical of Meeting around-the-clock opioid analgesic is disabilities or special needs. If you needed for an extended period of time. require special accommodations due to AGENCY: Food and Drug Administration, This formulation of hydrocodone a disability, please contact Philip HHS. bitartrate extended-release capsules Bautista at least 7 days in advance of the ACTION: Notice. represents the first single-entity (i.e., meeting. containing no other active FDA is committed to the orderly This notice announces a forthcoming pharmaceutical ingredients, such as conduct of its advisory committee meeting of a public advisory committee acetaminophen or ibuprofen) meetings. Please visit our Web site at of the Food and Drug Administration hydrocodone-containing drug product. http://www.fda.gov/ (FDA). The meeting will be open to the It will be formulated in dose strengths AdvisoryCommittees/ public. up to 50 milligrams, and administered AboutAdvisoryCommittees/ Name of Committee: Anesthetic and twice daily (i.e., every 12 hours). The ucm111462.htm for procedures on Analgesic Drug Products Advisory committee will be asked to determine public conduct during advisory Committee. whether the benefit-risk assessment of committee meetings. General Function of the Committee: this product favors its approval for Notice of this meeting is given under To provide advice and marketing. the Federal Advisory Committee Act (5 recommendations to the Agency on FDA intends to make background U.S.C. app. 2). FDA’s regulatory issues. material available to the public no later Dated: November 5, 2012. DATES: Date and Time: The meeting will than 2 business days before the meeting. be held on December 7, 2012, from 8 If FDA is unable to post the background Jill Hartzler Warner, a.m. to 5 p.m. material on its Web site prior to the Acting Associate Commissioner for Special Location: FDA White Oak Campus, meeting, the background material will Medical Programs. 10903 New Hampshire Ave., Building be made publicly available at the [FR Doc. 2012–27368 Filed 11–8–12; 8:45 am] 31 Conference Center, the Great Room location of the advisory committee BILLING CODE 4160–01–P (rm. 1503), Silver Spring, MD 20992– meeting, and the background material 0002. Information regarding special will be posted on FDA’s Web site after accommodations due to a disability, the meeting. Background material is DEPARTMENT OF HEALTH AND visitor parking, and transportation may available at http://www.fda.gov/ HUMAN SERVICES be accessed at: http://www.fda.gov/ AdvisoryCommittees/Calendar/ National Institutes of Health AdvisoryCommittees/default.htm; under default.htm. Scroll down to the the heading ‘‘Resources for You,’’ click appropriate advisory committee meeting Submission for OMB Review; on ‘‘Public Meetings at the FDA White link. Comment Request: Ethical Dilemmas Oak Campus.’’ Please note that visitors Procedure: Interested persons may in Surgery and Utilization of Hospital to the White Oak Campus must enter present data, information, or views, Ethics Consultation Service: A Survey through Building 1. orally or in writing, on issues pending Contact Person: Philip A. Bautista, before the committee. Written SUMMARY: Under the provisions of Center for Drug Evaluation and submissions may be made to the contact Section 3507(a)(1)(D) of the Paperwork Research, Food and Drug person on or before November 23, 2012. Reduction Act of 1995, the Clinical Administration, 10903 New Hampshire Oral presentations from the public will Center Department of Bioethics, the Ave., Bldg. 31, rm. 2417, Silver Spring, be scheduled between approximately 1 National Institutes of Health has MD 20993–0002, 301–796–9001, FAX: p.m. and 2:30 p.m. Those individuals submitted to the Office of Management 301–847–8533, email: interested in making formal oral and Budget (OMB) a request to review [email protected], or FDA presentations should notify the contact and approve the information collection Advisory Committee Information Line, person and submit a brief statement of listed below. This proposed information 1–800–741–8138 (301–443–0572 in the the general nature of the evidence or collection was previously published in Washington, DC area). A notice in the arguments they wish to present, the the Federal Register on November 28, Federal Register about last minute names and addresses of proposed 2011 on page 72955–72956 [FR DOC # modifications that impact a previously participants, and an indication of the 2011–30548] and allowed 60-days for announced advisory committee meeting approximate time requested to make public comment. Two comments were cannot always be published quickly their presentation on or before received by the NIH Department of enough to provide timely notice. November 14, 2012. Time allotted for Bioethics. The comments we received Therefore, you should always check the each presentation may be limited. If the included one request from a survey firm Agency’s Web site at http:// number of registrants requesting to that was interested in possibly www.fda.gov/AdvisoryCommittees/ speak is greater than can be reasonably administering the survey, and one

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request from the American Association intended to collect information about their practices. Second, they will of Medical Colleges (AAMC) that was the ethical dilemmas that surgeons have provide understanding of factors that interested in knowing what items were faced in their practices over the past determine the current utilization of in the survey instrument. The purpose year, and assess their experiences, if hospital consultation services by of this notice is to allow an additional any, with their hospital consultation surgeons. Third, information collected 30 days for public comment. The services. Specifically, the information on the barriers to surgeons’ use of ethics National Institutes of Health may not gathered in this study will be valuable consultation services will provide better conduct or sponsor, and the respondent in understanding the ethical dilemmas insight into the perspective and culture is not required to respond to, an that surgeons face, the utility of of surgery as it relates to ethical information collection that has been institution ethics consultations services dilemmas in their practices and how extended, revised, or implemented on or for surgeons, and to identify what ethics consultation services could better after October 1, 1995, unless it displays support surgeons when faced with these a currently valid OMB control number. barriers, if any, discourage surgeons Proposed Collection: Title: Ethical from utilizing these services. The results dilemmas. Frequency of Response: Dilemmas in Surgery and Utilization of of this study can be used by medical Once. Affected Public: Individuals; Hospital Ethics Consultation Service: A professionals, hospitals, and bioethicists Businesses or other for-profit. Type of Survey. Type of Information Collection in several important ways. First, they Respondents: Individuals. Request: NEW. Need and Use of will provide a better understanding the The annual reporting burden is as Information Collection: This survey is ethical dilemmas that surgeons face in follows:

Estimated Average Estimated total Estimated number of burden per annual burden Type of respondents number of responses per response hours respondents respondent (in hours) requested

Surgeons ...... 598 1 15/60 150

Total ...... 598 ...... 150

There are no capital, operating, or Danis, MD, Department of Clinical inventions to extend market coverage maintenance costs to report. Bioethics, National Institutes of Health, for companies and may also be available Request for Comments: Written Building 10, Room 1C118, Bethesda, for licensing. comments and/or suggestions from the MD 20892–1156; Telephone: 301–435– FOR FURTHER INFORMATION CONTACT: public and affected agencies are invited 8727; Facsimile: 301–496–0760; Email: Licensing information and copies of the on one or more of the following points: [email protected]. U.S. patent applications listed below (1) Whether the proposed collection of Comments Due Date: Comments may be obtained by writing to the information is necessary for the proper regarding this information collection are indicated licensing contact at the Office performance of the function of the best assured of having their full effect if of Technology Transfer, National agency, including whether the received within 30-days of the date of Institutes of Health, 6011 Executive information will have practical utility; this publication. Boulevard, Suite 325, Rockville, (2) The accuracy of the agency’s Dated: August 28, 2012. Maryland 20852–3804; telephone: 301– estimate of the burden of the proposed Laura Lee, 496–7057; fax: 301–402–0220. A signed collection of information, including the Project Clearance Liason, CC, National Confidential Disclosure Agreement will validity of the methodology and Institutes of Health. be required to receive copies of the assumptions used; (3) Ways to enhance [FR Doc. 2012–27445 Filed 11–8–12; 8:45 am] patent applications. the quality, utility, and clarity of the BILLING CODE 4140–01–P information to be collected; and (4) Cell Lines Expressing Nuclear and/or Ways to minimize the burden of the Mitochondrial RNase H1 collection of information on those who DEPARTMENT OF HEALTH AND Description of Technology: RNase H1 are to respond, including the use of HUMAN SERVICES has been shown to remove RNA/DNA appropriate automated, electronic, hybrids and either too much or too little mechanical, or other technological National Institutes of Health enzyme can lead to undesirable effects collection techniques or other forms of such as deletions of DNA. The gene information technology. Government-Owned Inventions; encoding RNase H1 in mammalian cells Direct Comments to OMB: Written Availability for Licensing produces two forms of the protein. One comments and/or suggestions regarding AGENCY: National Institutes of Health, is targeted to the nucleus of the cell and the item(s) contained in this notice, Public Health Service, HHS. the other to the mitochondrial organelle. especially regarding the estimated ACTION: Notice. To study the effects of expression as public burden and associated response well as to understand the regulation of time, should be directed to the: Office SUMMARY: The inventions listed below the frequency with which each form is of Management and Budget, Office of are owned by an agency of the U.S. made, NIH investigators constructed Regulatory Affairs, Government and are available for cells derived from HEK293 cells where [email protected] or by licensing in the U.S. in accordance with expression of each or both forms is/are fax to 202–395–6974, Attention: Desk 35 U.S.C. 207 to achieve expeditious expressed only after addition of Officer for NIH. To request more commercialization of results of doxycycline as a small molecule information on the proposed project or federally-funded research and inducer compound. The set of cell lines to obtain a copy of the data collection development. Foreign patent could be important in the process of plans and instruments, contact: Marion applications are filed on selected analysis of RNA/DNA hybrids as each

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cell line expresses different amounts of fragmentation and tagging of genomic Potential Commercial Applications: each form. DNA. Superior monoclonal antibody for Potential Commercial Applications: Potential Commercial Applications: Western blotting or immunohistology Research materials to study RNA/DNA Kits for whole genome sequencing. analysis of tissue sections hybrids Competitive Advantages: Competitive Advantages: Competitive Advantages: Not • Can easily be expressed in the • Superior binding specificity in available elsewhere bacterium, E. coli, and purified in large comparison to commercially available Development Stage: quantities. antibodies • • • Prototype Are soluble, stable and exist as Developed antibodies bind specific, • Pre-clinical smaller active complexes compared to characterized regions on neuregulin 2 • In vitro data available native enzymes. Development Stage: • • Prototype Inventors: Robert J. Crouch and Are fully active at room ° • In vitro data available Yutaka Suzuki (NICHD). temperature (23–30 C). • Have a higher transposition activity Inventors: Detlef Vullhorst, Andres Publication: Suzuki Y, et al. An and show minimal insertional sequence Buonanno, Irina Karavanov (all of upstream open reading frame and the bias in-vitro compared to the wild type. NICHD). context of the two AUG codons affect Development Stage: Intellectual Property: HHS Reference the abundance of mitochondrial and • Prototype Nos. E–188–2012/0, E–189–2012/0, E– nuclear RNase H1. Mol Cell Biol. 2010 • Pilot 190–2012/0, E–191–2012/0, E–192– Nov;30(21):5123–34. [PMID 20823270] • In vitro data available 2012/0, E–193–2012/0. This is a Intellectual Property: HHS Reference Inventors: Fred Dyda (NIDDK), Alison Research Tool—patent protection is not No. E–273–2012/0—Research Material. Hickman (NIDDK), Nancy Craig (Johns being pursued for this technology. Patent protection is not being pursued Hopkins School of Medicine), Sunil Licensing Contact: Lauren Nguyen- for this technology. Gangadharan (Johns Hopkins School of Antczak, Ph.D., J.D.; 301–435–4074; Licensing Contact: Betty B. Tong, Medicine). [email protected]. Ph.D.; 301–594–6565; Intellectual Property: HHS Reference Collaborative Research Opportunity: [email protected]. No. E–194–2012/0—U.S. Provisional The NICHD is seeking statements of Collaborative Research Opportunity: Application No. 61/652,560 filed 29 capability or interest from parties The Program in Genomics of May 2012. interested in collaborative research to Differentiation, NICHD, is seeking Licensing Contact: Lauren Nguyen- further develop, evaluate or statements of capability or interest from Antczak, Ph.D., J.D.; 301–435–4074; commercialize neuregulin-2 monoclonal parties interested in collaborative [email protected]. antibodies. For collaboration research to further develop, evaluate or opportunities, please contact Charlotte Improved Monoclonal Antibodies commercialize small molecule McGuinness at [email protected]. inhibitors of RNase H1, genome Against Neuregulin 2 instability, or transcription and Description of Technology: The Glucocerebrosidase Activators for the translation. For collaboration invention provides highly selective Treatment of Gaucher Disease, opportunities, please contact Joseph monoclonal antibodies against the Parkinson’s Disease, and Other Conrad III, Ph.D. at extracellular domain (ECD) or Proteinopathies [email protected]. intracellular domain (ICD) of Description of Technology: Gaucher neuregulin-2, a ligand for the ErbB disease is a rare lysosomal storage Improved Transposase Compositions receptors in adult human brain. disease that is characterized by a loss of for Whole Genome Sequencing Neuregulins regulate a diverse array of function of the glucocerebrosidase Description of Technology: The neurological process in the central (GCase) enzyme, which results in a invention provides improved nervous system and are implicated in decreased ability to degrade its lipid transposase enzymes engineered to schizophrenia and other psychiatric substrate, glucocerebroside. The exhibit reduced sequence biases, and to disorders. However, an understanding intracellular build up of this lipid operate more efficiently than wildtype of the specific role of neuregulin 2 has causes a broad range of clinical transposases. been hindered by a lack of specific manifestations, ranging from enlarged Scientists at NIDDK and John Hopkins antibodies useful in immunoblotting spleen/liver and anemia to University jointly developed mutant and immunohistology studies. neurodegeneration. In Gaucher disease, transposases that are superior to Commercially available antibodies do the loss of GCase function has been wildtype transposases in whole genome not perform as well in these attributed to low levels of the protein in sequencing applications. Transposases applications when compared to the the lysosomal compartment, resulting facilitate the cleavage of certain DNA invention antibodies. A mouse from improper GCase folding and segments, called transposons, at specific monoclonal antibody directed to the transport. Also, mutations in the GCase sites within a genome and their ECD is available for licensing (clone gene have been linked to some forms of subsequent insertions at random sites. 8D11, HHS Ref. No. E–192–2012), and Parkinson’s disease, and may also be Addition of transposases and labeled rabbit antibodies directed to the ICD are involved in other proteinopathies. transposons to whole genome also available (clone 11–11, HHS Ref. This technology describes a collection preparations allow for one-pot, No. E–193–2012; clone 15–10, HHS Ref. of salicylic acid-derived small simultaneous fragmentation and No. E–189–2012; and clone 9–2, HHS molecules that act as chaperones to identification of targeted DNA Ref. No. E–188–2012). Antibodies from activate proper GCase folding and sequences. clones 8D11 and 11–11 have been subsequent transport from the Mutations introduced by the validated for immunohistology and endoplasmic reticulum into the inventors facilitate formation of dimeric antibodies from clones 15–10 and 9–2 lysosome. Unlike many other small enzyme complexes with enhanced have been validated for Western blotting molecule chaperones, these salicylic activity and stability. These using brain tissue from wild-type and acid derivatives do not inhibit the modifications result in more efficient neuregulin 2 deficient mice. activity of the GCase enzyme. These

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small molecules have been tested for the cells and cells with Wolman disease, The technology consists of designed ability to activate GCase in vitro and and reduced the size of enlarged RNA switches that activate the RNA show chaperone activity in a patient- lysosomes in six patient cell lines with interference pathway only in the derived fibroblast translocation assay. LSDs. Further, CD in combination with presence of a trigger RNA or DNA to Potential Commercial Applications: tocopherol synergistically/additively which they bind, in order to knock • Treatment of Gaucher disease reduced cholesterol accumulation in down a chosen gene that is not • Treatment of Parkinson’s disease cells of NPC and Wolman diseases. necessarily related to the initial trigger. • Treatment of other lysosomal Based on these results, they propose This new approach can lead to a new storage diseases treatment of LSDs with cyclodextrins type of drug that has the unique feature Competitive Advantages: The (such as alpha and gamma forms) alone of selectively causing a biochemical compounds are novel small molecules or in combination with Vitamin E and effect (such as apoptosis) in cells that that enhance proper GCase folding and its analogues for better efficacy and less are infected by RNA viruses (such as transport without inhibiting enzyme side effects. HIV), as well as cancer cells. The RNA activity in the lysosome. Potential Commercial Applications: switch concept can be expanded to • Development Stage: Treatment of lysosomal storage selectively treat other genetically related • Early-stage diseases diseases. • • In vitro data available Treatment of disorders caused by Potential Commercial Applications: Inventors: Juan Marugan (NCATS), accumulation of non-cholesterol lipids • Targeted therapeutic for viral Wei Zheng (NCATS), Samarjit Patnaik Competitive Advantages: • infections, cancer stem cells, and (NCATS), Noel Southall (NCATS), Ellen Use of cyclodextrins in combination genetically related diseases Sidransky (NHGRI), Ehud Goldin with vitamin-E (e.g., delta-tocopherol) • Research tool to study cancer or (NHGRI), Wendy Westbroek (NHGRI). provides additive therapeutic effect • viral infection Publication: Related publication is Less side effects than cyclodextrin Competitive Advantages: currently in preparation. only or vitamin E only for LSDs because • Fewer side effects because the Intellectual Property: of reduced doses for both compounds in therapeutic RNA-interference pathway • HHS Reference No. E–144–2012/ combination is only activated by the RNA switch 0—U.S. Provisional Application No. 61/ Development Stage: when it is intact and in its active • Early-stage 616,758 filed 28 Mar 2012 • conformation • HHS Reference No. E–144–2012/ Pre-clinical • • In vitro data available Selectively kills cells infected by 1—U.S Provisional Application No. 61/ RNA viruses Inventors: John McKew, Wei Zheng, • 616,773 filed 28 Mar 2012 Miao Xu, Manju Swaroop, Juan Contains a minimal number of Licensing Contact: Tara Kirby, Ph.D.; Marugan (all of NCATS). single stranded nucleotides, thus 301–402–0220; [email protected]. Intellectual Property: HHS Reference minimizing the effects of nucleases Collaborative Research Opportunity: No. E–050–2012/0—US Provisional Development Stage: In vitro data The National Center for Advancing Application No. 61/679,668 filed 12 available Translational Sciences is seeking Aug 2012. Inventors: Bruce A. Shapiro (NCI), statements of capability or interest from Related Technology: HHS Reference Eckart Bindewald (SAIC-Frederick, parties interested in collaborative No. E–294–2009/0—PCT Patent Inc.), Kirill Afonin (NCI), Arti research to further develop, evaluate or Application No. PCT/US2011/044590 Santhanam (NCI). commercialize this technology. For filed 19 Jul 2011, entitled’’ ‘‘Use of Delta Publications: collaboration opportunities, please Tocopherol for the Treatment of 1. Afonin KA, et al. Co-transcriptional contact Dr. Juan Marugan at Lysosomal Storage Disorders’’ (Wei Assembly of Chemically Modified RNA [email protected]. Zheng et al., NCATS). Nanoparticles Functionalized with siRNAs. Nano Lett. 2012 Oct Cyclodextrins as Therapeutics for Licensing Contact: Suryanarayana 10;12(10):5192–5. [PMID 23016824] Lysosomal Storage Disorders Vepa, Ph.D., J.D.; 301–435–5020; [email protected]. 2. Grabow WW, et al. ‘‘RNA Description of Technology: Collaborative Research Opportunity: Nanotechnology in Nanomedicine,’’ in Cyclodextrins (CD), alone or in The National Center for Advancing Nanomedicine and Drug Delivery combination with other agents (e.g., Translational Sciences is seeking (Recent Advances in Nanoscience and vitamin E), as therapeutics for the statements of capability or interest from Nanotechnology), ed. M Sebastian, et al. treatment of lysosomal storage disorders parties interested in collaborative (New Jersey: Apple Academic Press, (LSDs) caused by the accumulation of research to further develop, evaluate or 2012), 208–220. [Book Chapter] non-cholesterol lipids. commercialize this technology. For 3. Shukla GC, et al. A boost for the CDs are sugar molecules in a ring collaboration opportunities, please emerging field of RNA nanotechnology. form. The alpha-CD (6 sugars), beta-CD contact Dr. Juan Marugan at ACS Nano. 2011 May 24;5(5):3405–18. (7 sugars) and gamma-CD (8 sugars) are [email protected]. [PMID 21604810] commonly used cyclodextrins. The 4. Afonin KA, et al. Design and self- hydroxypropyl-beta cyclodextrin Selective Treatment of Cancer, HIV, assembly of siRNA-functionalized RNA (HPbCD) has been approved for Other RNA Viruses and Genetically nanoparticles for use in automated pharmaceutical use. Recent reports Related Diseases Using Therapeutic nanomedicine. Nat Protoc. 2011 Dec show that beta-cyclodextrin including RNA Switches 1;6(12):2022–34. [PMID 22134126] HPbCD and beta-methyl-cyclodextrin Description of Technology: Targeted 5. Bindewald E, et al. Multistrand reduced cholesterol accumulation and therapy in cancer or viral infections is RNA secondary structure prediction and neuronal cell loss in the mouse model a challenge because the disease state nanostructure design including of NPC1 disease. manifests itself mainly through pseudoknots. ACS Nano. 2011 Dec NCATS investigators found that CD differences in the cell interior, for 27;5(12):9542–51. [PMID 22067111] (alpha-, beta- and gamma-CDs) example in the form of the presence of 6. Grabow WW, et al. Self-assembling increased intracellular Ca2+ and a certain RNAs or proteins in the RNA nanorings based on RNAI/II lysosomal exocytosis in both wild type cytoplasm. inverse kissing complexes. Nano Lett.

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2011 Feb9;11(2):878–87. [PMID hybrids is functionally inactive and Nanotechnology), ed. M Sebastian, et al. 21229999] functional representation can only be (New Jersey: Apple Academic Press, 7. Kasprzak W, et al. Use of RNA activated by the re-association of at least 2012), 208–220. [Book Chapter] structure flexibility data in two cognate hybrids simultaneously 3. Shukla GC, et al. A boost for the nanostructure modeling. Methods. 2011 present in the same cell. Overall, this emerging field of RNA nanotechnology. Jun;54:239–50. [PMID 21163354] novel approach allows (i) The triggered ACS Nano. 2011 May 24;5(5):3405–18. 8. Afonin KA, et al. In vitro assembly release of therapeutic siRNAs or [PMID 21604810] of cubic RNA-based scaffolds designed miRNAs inside the diseased cells, (ii) 4. Afonin KA, et al. Design and self- in silico. Nat Nanotechnol. 2010 activation of other split functionalities assembly of siRNA-functionalized RNA Sep;5:676–82. [PMID 20802494] (e.g. FRET, different aptamers, nanoparticles for use in automated 9. Severcan I, et al. ‘‘Computational rybozymes, split proteins) nanomedicine. Nat Protoc. 2011 Dec and Experimental RNA Nanoparticle intracellularly, (iii) higher control over 1;6(12):2022–34. [PMID 22134126] Design,’’ in Automation in Genomics targeting specificity (e.g. if two hybrids 5. Bindewald E, et al. Multistrand and Proteomics: An Engineering Case- are decorated with two different tissue RNA secondary structure prediction and Based Approach, ed. G Alterovitz, et al. specific recognition moieties), (iv) nanostructure design including (Hoboken: Wiley Publishing, 2009), biosensing and tracking of the delivery pseudoknots. ACS Nano. 2011 Dec 193–220. [Book Chapter] and re-association of these hybrids in 27;5(12):9542–51. [PMID 22067111] 10. Shapiro B, et al. ‘‘Protocols for the real-time inside cells, (v) increasing the 6. Grabow WW, et al. Self-assembling RNA nanorings based on RNAI/II In silico Design of RNA number of functionalities by inverse kissing complexes. Nano Lett. Nanostructures,’’ in Nanostructure introducing a branched hybrid 2011 Feb9;11(2):878–87. [PMID Design Methods and Protocols, ed. E structure, (vi) introduction of additional Gazit, R Nussinov. (Totowa, NJ: Humana 21229999] functionalities without direct 7. Kasprzak W, et al. Use of RNA Press, 2008), 93–115. [Book Chapter] interference of siRNA processivity, (vii) 11. Bindewald E, et al. Computational structure flexibility data in increasing the retention time in nanostructure modeling. Methods. 2011 strategies for the automated design of biological fluids by fine-tuning chemical RNA nanoscale structures from building Jun;54:239–50. [PMID 21163354] stability through substituting the DNA 8. Afonin KA, et al. In vitro assembly blocks using NanoTiler. J Mol Graph strands with chemical analogs (e.g. Model. 2008 Oct;27(3):299–308. [PMID of cubic RNA-based scaffolds designed LNA, PNA, etc.), (viii) conditional in silico. Nat Nanotechnol. 2010 18838281] release of all functionalities. 12. Yingling YG, Shapiro BA. Sep;5:676–82. [PMID 20802494] Potential Commercial Applications: 9. Severcan I, et al. ‘‘Computational Computational design of an RNA • Therapeutic siRNA for cancer, and Experimental RNA Nanoparticle hexagonal nanoring and an RNA viruses and other diseases Design,’’ in Automation in Genomics nanotube. Nano Lett. 2007 Aug;7(8): • Therapeutic for delivery of multiple and Proteomics: An Engineering Case- 2328–34. [PMID 17616164] functionalities Based Approach, ed. G Alterovitz, et al. Intellectual Property: • Diagnostic to visualize cancer cells, • (Hoboken: Wiley Publishing, 2009), HHS Reference No. E–038–2012/0 virus infected cells, or diseased cells, or — U.S. Provisional Application No. 61/ 193–220. [Book Chapter] track the delivery and effectiveness of 10. Shapiro B, et al. ‘‘Protocols for the 561,247 filed 17 Nov 2011 siRNA treatment or other treatments • HHS Reference No. E–038–2012/1 In silico Design of RNA associated with the particle Nanostructures,’’ in Nanostructure — U.S. Provisional Application No. 61/ • Research tool to study cancer, viral Design Methods and Protocols, ed. E 678,434 filed 01 Aug 2012 infections or other diseases Gazit, R Nussinov. (Totowa, NJ: Humana Related Technology: HHS Reference Competitive Advantages: No. E–039–2012/0—U.S. Provisional • Press, 2008), 93–115. [Book Chapter] Novel way for multiple 11. Bindewald E, et al. Computational Application No. 61/561,257 filed 17 functionality delivery and activation strategies for the automated design of Nov 2011. • Enhanced chemical stability and RNA nanoscale structures from building Licensing Contact: John Stansberry, pharmacokinetics due to the average blocks using NanoTiler. J Mol Graph Ph.D.; 301–435–5236; size of nanoparticles exceeding 10nm Model. 2008 Oct;27(3):299–308. [PMID [email protected]. • Increased specificity for selecting 18838281] Collaborative Research Opportunity: cells of interest using more than one 12. Yingling YG, Shapiro BA. The NCI Center for Cancer Research target gene Computational design of an RNA Nanobiology Program is seeking Development Stage: hexagonal nanoring and an RNA statements of capability or interest from • In vitro data available • nanotube. Nano Lett. 2007 Aug;7(8): parties interested in collaborative In vivo data available (animal) 2328–34. [PMID 17616164] research to further develop, evaluate or Inventors: Bruce A. Shapiro (NCI), Intellectual Property: HHS Reference commercialize therapeutic RNA Kirill Afonin (NCI), Arti Santhanam No. E–039–2012/0—U.S. Provisional switches. For collaboration (NCI), Mathias Viard (SAIC-Frederick, Application No. 61/561,257 filed 17 opportunities, please contact John Inc.), Eckart Bindewald (SAIC- Nov 2011 Hewes, Ph.D. at [email protected]. Frederick, Inc.), Luc Jaeger (U of Cal. Related Technology: Santa Barbara). • Activation of Therapeutic HHS Reference No. E–038–2012/ Publications: 0—U.S. Provisional Application No. 61/ Functionalities With Chimeric RNA/ 1. Afonin KA, et al. Co-transcriptional DNA Nanoparticles for Treatment of 561,247 filed 17 Nov 2011 Assembly of Chemically Modified RNA • HHS Reference No. E–038–2012/ Cancer, Viruses and Other Diseases Nanoparticles Functionalized with 1—U.S. Provisional Application No. 61/ Description of Technology: A new siRNAs. Nano Lett. 2012 Oct 678,434 filed 01 Aug 2012 strategy based on RNA/DNA hybrid 10;12(10):5192–5. [PMID 23016824] Licensing Contact: John Stansberry, nanoparticles, which can be generally 2. Grabow WW, et al. ‘‘RNA Ph.D.; 301–435–5236; used for triggering multiple Nanotechnology in Nanomedicine,’’ in [email protected]. functionalities inside diseased cells is Nanomedicine and Drug Delivery Collaborative Research Opportunity: presented. Individually, each of the (Recent Advances in Nanoscience and The NCI Center for Cancer Research

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Nanobiology Program is seeking applications, the disclosure of which DEPARTMENT OF HEALTH AND statements of capability or interest from would constitute a clearly unwarranted HUMAN SERVICES parties interested in collaborative invasion of personal privacy. National Institutes of Health research to further develop, evaluate or Name of Committee: Center for Scientific commercialize therapeutic RNA/DNA Review Special Emphasis Panel Neuronal nanoparticles. For collaboration National Institute of General Medical Plasticity and Regeneration. Sciences; Notice of Closed Meeting opportunities, please contact John Date: November 28–29, 2012. Hewes, Ph.D. at [email protected]. Time: 9:30 a.m. to 4:00 p.m. Pursuant to section 10(d) of the Dated: November 5, 2012. Agenda: To review and evaluate grant Federal Advisory Committee Act, as Richard U. Rodriguez, applications. amended (5 U.S.C. App.), notice is Director, Division of Technology Development Place: National Institutes of Health, 6701 hereby given of the following meeting. and Transfer, Office of Technology Transfer, Rockledge Drive, Bethesda, MD 20892, The meeting will be closed to the National Institutes of Health. (Virtual Meeting). public in accordance with the [FR Doc. 2012–27426 Filed 11–8–12; 8:45 am] Contact Person: Laurent Taupenot, Ph.D., provisions set forth in sections Scientific Review Officer, Center for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P Scientific Review, National Institutes of as amended. The grant applications and Health, 6701 Rockledge Drive, Room 4811, the discussions could disclose DEPARTMENT OF HEALTH AND MSC 7850, Bethesda, MD 20892, 301–435– confidential trade secrets or commercial HUMAN SERVICES 1203, [email protected]. property such as patentable material, This notice is being published less than 15 and personal information concerning National Institutes of Health days prior to the meeting due to the timing individuals associated with the grant limitations imposed by the review and applications, the disclosure of which National Human Genome Research funding cycle. would constitute a clearly unwarranted Institute; Amended Notice of Meeting Name of Committee: Center for Scientific invasion of personal privacy. Review Special Emphasis Panel Molecular Notice is hereby given of a change in Name of Committee: National Institute of Mechanism of Neurodegeneration. General Medical Sciences Special Emphasis the meeting of the National Human Date: December 6–7, 2012. Panel Review of K99 Grant Applications. Genome Research Institute Special Time: 8:00 a.m. to 4:00 p.m. Date: December 5, 2012. Emphasis Panel, October 29, 2012, 8:00 Agenda: To review and evaluate grant Time: 8:00 a.m. to 5:00 p.m. a.m. to October 30, 2012, 5:00 p.m., applications. Agenda: To review and evaluate grant Residence Inn Bethesda Downtown, Place: National Institutes of Health, 6701 applications. 7335 Wisconsin Avenue, Montgomery I Rockledge Drive, Bethesda, MD 20892 Place: National Institutes of Health, & II, Bethesda, MD 20814 which was (Virtual Meeting). Natcher Building, 45 Center Drive, Room A, Contact Person: Carol Hamelink, Ph.D., Bethesda, MD 20892. published in the Federal Register on Contact Person: John J. Laffan, Ph.D., Scientific Review Officer, Center for October 4, 2012, 77 FR 60706. Scientific Review Officer, Office of Scientific Due to Hurricane Sandy, this meeting Scientific Review, National Institutes of Review, National Institute of General Medical has been moved from October 29–30, Health, 6701 Rockledge Drive, Room 4192, Sciences, National Institutes of Health, 45 2012 to January 7, 2013. The meeting is MSC 7850, Bethesda, MD 20892, (301) 213– Center Drive, Room 3An18J, Bethesda, MD closed to the public. 9887, [email protected]. 20892, 301–594–2773, [email protected]. Dated: November 5, 2012. Name of Committee: Center for Scientific (Catalogue of Federal Domestic Assistance Review Special Emphasis Panel Member Program Nos. 93.375, Minority Biomedical David Clary, Conflicts: Asthma, Allergy, and Research Support; 93.821, Cell Biology and Program Analyst, Office of Federal Advisory Environmental Exposure Applications. Biophysics Research; 93.859, Pharmacology, Committee Policy. Date: December 10, 2012. Physiology, and Biological Chemistry Research; 93.862, Genetics and [FR Doc. 2012–27429 Filed 11–8–12; 8:45 am] Time: 1:30 p.m. to 4:30 p.m. BILLING CODE 4140–01–P Developmental Biology Research; 93.88, Agenda: To review and evaluate grant Minority Access to Research Careers; 93.96, applications. Special Minority Initiatives, National Place: National Institutes of Health, 6701 Institutes of Health, HHS) DEPARTMENT OF HEALTH AND Rockledge Drive, Bethesda, MD 20892 HUMAN SERVICES (Telephone Conference Call). Dated: November 5, 2012. Contact Person: Everett E. Sinnett, Ph.D., Melanie J. Gray, National Institutes of Health Scientific Review Officer, Center for Program Analyst, Office of Federal Advisory Center for Scientific Review; Notice of Scientific Review, National Institutes of Committee Policy. Closed Meetings Health, 6701 Rockledge Drive, Room 2178, [FR Doc. 2012–27427 Filed 11–8–12; 8:45 am] MSC 7818, Bethesda, MD 20892, 301–435– BILLING CODE 4140–01–P Pursuant to section 10(d) of the 1016, [email protected]. Federal Advisory Committee Act, as (Catalogue of Federal Domestic Assistance amended (5 U.S.C. App.), notice is Program Nos. 93.306, Comparative Medicine; DEPARTMENT OF HEALTH AND hereby given of the following meetings. 93.333, Clinical Research, 93.306, 93.333, HUMAN SERVICES The meetings will be closed to the 93.337, 93.393–93.396, 93.837–93.844, public in accordance with the 93.846–93.878, 93.892, 93.893, National National Institutes of Health Institutes of Health, HHS) provisions set forth in sections National Institute of Allergy and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Dated: November 5, 2012. Infectious Diseases; Notice of Closed as amended. The grant applications and Meeting the discussions could disclose Melanie J. Gray, confidential trade secrets or commercial Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the property such as patentable material, Committee Policy. Federal Advisory Committee Act, as and personal information concerning [FR Doc. 2012–27430 Filed 11–8–12; 8:45 am] amended (5 U.S.C. App.), notice is individuals associated with the grant BILLING CODE 4140–01–P hereby given of the following meeting.

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The meeting will be closed to the DEPARTMENT OF HOUSING AND decent housing, suitable living public in accordance with the URBAN DEVELOPMENT environments, and economic opportunities primarily for persons with provisions set forth in sections [Docket No. FR–5600–FA–02] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., low and moderate incomes as defined in as amended. The contract proposals and Announcement of Funding Awards; 24 CFR 1003.4. the discussions could disclose Indian Community Development Block The FY 2012 awards announced in confidential trade secrets or commercial Grant Program; Fiscal Year 2012 this Notice were selected for funding in property such as patentable material, a competition posted on HUD’s Web site AGENCY: Office of the Assistant and personal information concerning on October 4, 2011 and in a technical Secretary for Public and Indian amendment posted on November 11, individuals associated with the contract Housing, HUD. proposals, the disclosure of which 2011. Applications were scored and ACTION: Announcement of funding would constitute a clearly unwarranted selected for funding based on the awards. invasion of personal privacy. selection criteria in those notices and SUMMARY: In accordance with Section Area ONAP geographic jurisdictional Name of Committee: National Institute of competitions. Allergy and Infectious Diseases Special 102(a)(4)(C) of the Department of The amount appropriated in FY 2012 Emphasis Panel NIAID Peer Review Meeting. Housing and Urban Development to fund the ICDBG was $60,000,000. Of Date: December 5, 2012. Reform Act of 1989, this announcement this amount $3,960,000 was retained to Time: 9:00 a.m. to 2:00 p.m. notifies the public of funding decisions Agenda: To review and evaluate contract made by the Department in a fund imminent threat grants in FY 2012. proposals. competition for funding under the In addition, a total of $400,000 in Place: National Institutes of Health, 6700B Fiscal Year 2012 (FY 2012) Notice of carryover funds from prior years was Rockledge Drive, Bethesda, MD 20817 Funding Availability (NOFA) for the also available. The allocations for the (Telephone Conference Call). Indian Community Development Block Area ONAP geographic jurisdictions, Contact Person: Andrea L. Wurster, Ph.D., Grant (ICDBG) Program. This including carryover from prior years, are Scientific Review Officer, Scientific Review announcement contains the as follows: Program, DEA/NIAID/NIH/DHHS, Room consolidated names and addresses of Eastern/Woodlands: $6,468,576 2217, 6700B Rockledge Drive, MSC–7616, this year’s award recipients under the Southern Plains: 11,918,554 Bethesda, MD 20892–761, 301–496–2550, ICDBG. Northern Plains: 8,095,270 [email protected]. Southwest: 20,969,820 FOR FURTHER INFORMATION CONTACT: For Northwest: 2,876,273 (Catalogue of Federal Domestic Assistance questions concerning the ICDBG Alaska: 6,073,337 Program Nos. 93.855, Allergy, Immunology, Program awards, contact the Area Office and Transplantation Research; 93.856, of Native American Programs (ONAP) Total 56,401,830 Microbiology and Infectious Diseases serving your area or Glenda Green, Research, National Institutes of Health, HHS) Director, Office of Native Programs, 451 In accordance with Section 7th Street SW., Washington, DC 20410, 102(a)(4)(C) of the Department of Dated: November 5, 2012. telephone number 202–402–6329. Housing and Urban Development David Clary, Hearing or speech-impaired individuals Reform Act of 1989 (103 Stat.1987, 42 may access this number via TTY by U.S.C. 3545), the Department is Program Analyst, Office of Federal Advisory publishing the names, addresses, and Committee Policy. calling the toll-free Federal Relay amounts of the 76 awards made under [FR Doc. 2012–27428 Filed 11–8–12; 8:45 am] Service at telephone number 800–877– 8339. the various regional competitions in BILLING CODE 4140–01–P Appendix A to this document. SUPPLEMENTARY INFORMATION: This program provides grants to Indian tribes Dated: October 24, 2012. and Alaska Native Villages to develop Sandra B. Henriquez, viable Indian and Alaska Native Assistant Secretary for Public and Indian communities, including the creation of Housing.

APPENDIX A

Amount Name/Address of applicant funded Activity funded Project description

Agdaagux Tribe of King Cove, Dale Gould, President, P.O. $28,175 Housing Rehabilitation...... Replacement of meter boxes on 60 Box 249, King Cove, AK 99612, (907) 497–2648. homes. All Mission Indian Housing Authority (LaJolla) Dave Shaffer, 364,679 Housing Construction ...... Construction of 2 homes. Executive Director, 27740 Jefferson Ave, Ste 260, Temecula, CA 92590, (951) 760–7390. All Mission Indian Housing Authority (Pauma), Dave 547,679 Housing Construction ...... Construction of 3 homes. Shaffer, Executive Director, 27740 Jefferson Ave, Ste 260, Temecula, CA 92590, (951) 760–7390. All Mission Indian Housing Authority (Santa Rosa), Dave 547,679 Public Facility—Infrastructure Infrastructure improvements that will Shaffer, Executive Director, 27740 Jefferson Ave, Ste provide access to reservation hous- 260, Temecula, CA 92590, (951) 760–7390. ing. All Mission Indian Housing Authority (Torres-Martinez), 550,635 Housing Construction ...... Construction of 3 homes. Dave Shaffer, Executive Director, 27740 Jefferson Ave, Ste 260, Temecula, CA 92590, (951) 760–7390. Arctic Village, Raymond Tritt, First Chief, P.O. Box 22069, 530,000 Housing Construction ...... Construction of 2 homes. Arctic Village, AK 99722, (907) 587–5523.

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APPENDIX A—Continued

Amount Name/Address of applicant funded Activity funded Project description

Bear River Band of Rohnerville Rancheria, Honorable 605,000 Housing Construction ...... Construction of 4 homes. Leonard Bowman, Chairman, 27 Bear River Drive, Loleta, CA 95551, (707) 534–3859. Big Pine Paiute Tribe of the Owens Valley, Honorable Virgil 605,000 Housing Rehabilitation ...... Rehabilitation of 12 homes. Moose, Chairperson, P.O. Box 700, Big Pine, CA 93513, (760) 938–2003. Bois Forte Band of the Minnesota Chippewa Tribe, Sidra 600,000 Public Facility—Community Pow-Wow grounds and softball fields. Starkovich, P.O. Box 16—1374 Nett, Nett Lake, MN Center. 55772, (218) 757–3261. Caddo Nation, Honorable Brenda Edwards, Chairman, P.O. 800,000 Public Facility—Community Social Services Building. Box 487, Binger, OK 73009, (405) 656–2344. Center. Campo Band of Diegueno Mission Indians, Honorable 605,000 Housing Construction ...... Construction of 4 homes. Monique La Chappa, Chairperson, 36190 Church Road, Suite 1, Campo, CA 91906, (619) 478–9046. Chemehuevi Indian Tribe, Honorable Charles Wood, Chair- 604,998 Public Facility—Infrastructure Replacement of antiquated sewer person, P.O. Box 1976, Havasu Lake, CA 92363, (760) lines. 858–4219. Chickasaw Nation, Honorable Bill Anoatubby, Governor, 800,000 Public Facility—Community Renovation of old gymnasium. P.O. Box 1548, Ada, OK 74821, (580) 436–2603. Center. Chippewa Cree Tribe, Honorable Bruce Sunchild, Tribal 900,000 Public Facility—Infrastructure Smallville Water Improvement Project. Chairman, 31 Agency Square, Box Elder, MT 59521, (406) 395–5705. Choctaw Nation, Honorable Gregory E. Pyle, Chief, P.O. 800,000 Public Facility—Infrastructure Pocola sanitary sewer. Drawer 1210, Durant, OK 74702, (580) 924–8280. Cocopah Indian Housing and Development, Dr. Michael 605,000 Housing Rehabilitation ...... Rehabilitation of 10 homes. Reed, Executive Director, 10488 Steamboat Street, Somerton, AZ 85350, (928) 627–8863. Coeur D’Alene Tribal Housing Authority, Rosanna Allen, 455,200 Public Facility—Infrastructure Construction of a sewage lagoon. P.O. Box 267, Plummer, ID 83851, (208) 686–1927. Cook Inlet Tribal Council, Honorable Gloria O’Neill, Presi- 600,000 Public Facility—Special Construction of a group home for Alas- dent, 3600 San Jeronimo, Anchorage, AK 99508, (907) Needs. ka youth. 793–3088. Crow Creek Housing Authority, Joseph Sazue, Jr. Execu- 900,000 Housing Rehabilitation...... Rehabilitation of 17 rental and 17 tive Director, P.O. Box 19, Fort Thompson, SD 57339, owner-occupied housing units. (605) 245–2250. Dry Creek Rancheria Band of Pomo Indians, Honorable 605,000 Homebuyer Assistance ...... Homeowner Assistance Program. Harvey Hopkins, Chairperson, P.O. Box 607, Geyserville, CA 95448, (707) 522–4290. Eastern Band of Cherokee Indians of NC, Kim Deas, P.O. 468,576 Public Facility—Community Construction of a children’s home. Box 455, Cherokee, NC 28719, (828) 497–2771. Center. Eastern Shawnee Tribe of Oklahoma, Honorable Glenna J. 800,000 Public Facility—Community Elder Community Center. Wallace, Chief, P.O. Box 350, Seneca, OK 64865, (918) Center. 666–2435. Ekwok Village, Honorable Luki Akelkok, President, P.O. 600,000 Housing Construction ...... Construction of 6 new homes. Box 70, Ekwok, AK 99580, (907) 464–3336. Ely Shoshone Tribe, Honorable Alvin Marques, Chair- 605,000 Housing Construction ...... Rehabilitation of 13 homes. person, 16 Shoshone Circle, Ely, Nevada 89301, (775) 289–3013. Enterprise Rancheria, Honorable Glenda Nelson, Chair- 595,000 Land for Housing ...... Purchase of 4 existing homes. person, 2133 Monte Vista, Oroville, CA 95966, (530) 532–9214. Fort McDermitt Paiute-Shoshone Tribe, Honorable Billy 605,000 Economic Development ...... Construction of Travel Plaza. Bell, Chairperson, P.O. Box 457, Fort McDermitt, NV, (775) 532–8913. Gila River Health Corporation, Heather Chavez, Executive 2,750,000 Public Facility—Infrastructure Renovation/expansion of the Primary Director, P.O. Box 38, Sacaton, AZ 85147, (602) 528– Care Department and constructing a 1456. Dental Addition. Grand Ronde Tribe, Cheryle Kennedy, 9615 Grand Ronde 500,000 Public Facility—Community Construction of a Food Bank facility. Road, Grand Ronde, OR 97347, (503) 879–5211. Center. Hannahville Indian Community, Jill Beaudo, N14911 600,000 Housing Construction ...... Transitional Housing Facility. Hannahville B1 Road, Wilson, MI 49896, (906) 466–2342. Ho-Chunk Community Development Corporation, Frank 695,270 Housing Rehabilitation...... Rehabilitation of 15 single family Schersing, Executive Director, 509 Ho-Chunk Plaza homes. North, Winnebago, NE 68071, (402) 878–2192. Ho-Chunk Nation of Wisconsin, Paul Tysse, W9814 Airport 600,000 Housing Rehabilitation...... Installation of solar panels on LMI Rd, Black River Falls, WI 54615, (715) 284–9343. housing. Hualapai Indian Tribe, Honorable Wilfred Whatoname, Sr., 825,000 Public Facility—Special Accessibility improvements to existing Chairperson, P.O. Box 179, Peach Springs, AZ 86434, Needs. public buildings and improvements (928) 769–2216. to the Youth Camp. Kalispel Tribe, Glen Nenema, P.O. Box 3, Usk, WA 99180, 421,073 Public Facility—Infrastructure Construction of an Elder Center. (509) 445–1705.

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APPENDIX A—Continued

Amount Name/Address of applicant funded Activity funded Project description

Karuk Tribe of California, Honorable Russell Attebery, 605,000 Public Facility—Community Wellness Center to provide recreation Chairperson, P.O. Box 1016, Happy Camp, CA 96039, Center. and other activities. (530) 493–5305. Kaw Nation, Honorable Guy Munroe, Chairman, Drawer 50, 800,000 Economic Development ...... Expansion of a travel plaza. Kaw City, OK 74641, (580) 269–2552. Klamath Indian Tribe, Gary Frost, P.O. Box 436, Chiloquin, 500,000 Public Facility—Community Construction of a preschool center. OR 97624, (541) 783–2210. Center. Lac du Flambeau Band of Lake Superior Chippewa Indi- 600,000 Public Facility—Community Art and Cultural Center. ans, Patricia O’Neil, P.O. Box 67, Lac du Flambeau, WI Center. 54538, (715) 588–3303. Lower Brule Sioux Tribe, Honorable Michael Jandreau, 900,000 Housing Rehabilitation ...... Rehabilitation of 58 rental homes on Tribal Chairman, 187 Oyate Circle, Lower Brule, SD Lower Brule Reservation. 57548, (605) 473–5561. Lummi Tribal Housing Authority, Diana Phair, 2828 Kwina 500,000 Public Facility—Infrastructure Construction of roads and utilities for Road, Bellingham, WA 98226, (541) 783–2210. 66 new units. Mentasta Traditional Council, C. Nora David, First Chief, 600,000 Public Facility—Community Construction of a Health Facility. P.O. Box 601, Mentasta, AK 99780, (907) 291–2319. Center. Muscogee Creek Nation, Honorable George Tiger, Principal 800,000 Public Facility—Community Student Auxiliary Services Center. Chief, P.O. Box 580, Okmulgee, OK 74447, (918) 756– Center. 8700. Native Village of Buckland, Honorable Floyd Ticket, Presi- 600,000 Housing Construction ...... Construction of 5 homes. dent, P.O. Box 67, Buckland, AK 99727, (907) 494–2171. Native Village of Chitina, Honorable Ronald Mahle, Presi- 600,000 Housing Construction ...... Construction of 3 homes. dent, P.O. Box 31, Chitina, AK 99566, (907) 823–2215. Native Village of Kiana, Honorable Larry Westlake, Sr., 600,000 Housing Rehabilitation ...... Rehabilitation of 25 homes. President, P.O. Box 69, Kiana, AK 99749, (907) 475– 2109. Navajo Nation, Honorable Ben Shelly, President, P.O. Box 5,500,000 Public Facility—Infrastructure Provide Power Lines & Water Treat- 7440, Window Rock, AZ 86515, (928) 871–6352. ment Facilities within the Navajo Na- tion. North Fork Rancheria of Mono Indians, Honorable Judy 605,000 Public Facility—Community Center for vocational training and job Fink, Chairperson, P.O. Box 929, North Fork, CA 93643, Center. placement and transportation serv- (559) 877–2461. ices for low income residents. Northern Cheyenne Tribal Housing Authority, Lafe Haugen, 900,000 Housing Rehabilitation...... Rehabilitation of 27 owner-occupied Executive Director, P.O. Box 327, Lame Deer, MT housing units. 59043, (406) 477–6419. Northern Pueblos Housing Authority, Mr. Terry Hudson, Ex- 599,150 Housing Construction ...... Construction of 10 homes. ecutive Director, 5 West Gutierrez, Santa Fe, NM 87506, (888) 347–6360. Oneida Tribe of Indians of Wisconsin, Dale Wheelock, P.O. 600,000 Public Facility—Infrastructure Water and sewer lines for 40 housing Box 365, Oneida, WI 54155, (920) 869–2227. units. Organized Village of Kasaan, Honorable Richard Peterson, 599,457 Public Facility—Community Renovation of an existing structure for President, P.O. Box 26, Ketchikan, AK 99950, (907) Center. a community facility. 542–2230. Ottawa Tribe of Oklahoma, Honorable Ethel E. Cook, Chief, 800,000 Economic Development ...... Construction of a travel plaza. P.O. Box 110, Miami, OK 74355, (918) 540–1536. Paiute Indian Tribe of Utah, Honorable Gayle Rollo, Tribal 900,000 Economic Development...... Development of an RV park and, Chairperson 440 North Paiute Drive, Cedar City, UT Campground. 84721, (435) 586–1112. Pauloff Harbor Village, Honorable Gayle Rollo, Tribal Chair- 356,218 Housing Construction ...... Construction of 1 home. person, P.O. Box 19, Sand Point, AK 99661, (907) 383– 6075. Pawnee Nation, Honorable Marshall Gover, President, P.O. 800,000 Public Facility—Community Design and construction of Pawnee Box 470, Pawnee, OK 74058, (918) 762–3621. Center. Tribal Elder Center. Pokagon Band of Potawatomi Indians, Kevin Daugherty, 600,000 Public Facility—Infrastructure Waterline extension project. P.O. Box 180, Dowagiac, MI 49047, (269) 782–8998. Pueblo of Acoma Housing Authority, Floyd Tortalita, Execu- 825,000 Housing Rehabilitation ...... Rehabilitation of 20 homes. tive Director, P.O. Box 309, Acoma Pueblo, NM 87034, (505) 552–5174. Qawalangin Tribe of Unalaska, Honorable Denise Rankin, 419,487 Housing Construction ...... Construction of 1 home. President, P.O. Box 33, Unalaska, AK 99685, (907) 581– 2920. Quapaw Tribe of Oklahoma, Honorable John Berrey, Chair- 800,000 Public Facility—Community Construction of a wellness center and man, P.O. Box 765, Quapaw, OK 74363, (918) 542–1853. Center. community safe room. Resighini Rancheria, Honorable Donald McCovey, Chair- 605,000 Economic Development ...... Rehabilitation and improvement to the person, P.O. Box 529, Klamath, CA 95548, (707) 482– Chere-ere Bridge RV Park. 2431. Sac & Fox Tribe of the Mississippi in Iowa, Larry Lasley, 600,000 Economic Development ...... Construct a Travel Center. Route 2, Box 56C, Tama, IA 52339, (641) 484–4678.

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APPENDIX A—Continued

Amount Name/Address of applicant funded Activity funded Project description

Salish & Kootenai Housing Authority, Jason Adams, Execu- 1,100,000 Housing Rehabilitation ...... Rehabilitation of 14 owner-occupied/3 tive Director, P.O. Box 38, Pablo, MT 59855, (406) 675– rental units and homebuyer assist- 4491. ance. Sault Ste. Marie Tribe of Chippewa Indians of MI, Joanne 600,000 Public Facility Infrastructure Waterline extension project. Umbrasas, 523 Ashmun Street, Sault Ste. Marie, MI 49783, (906) 635–6050. Seminole Nation, Honorable Leonard Harjo, Principal Chief, 800,000 Public Facility—Community Construction of a multi-purpose com- P.O. Box 1498, Weoka, OK 74884, (405) 257–6287. Center. munity health and wellness center. Seneca Cayuga Tribe of Oklahoma, Honorable Leroy How- 800,000 Public Facility—Community Construction of a Family Services ard, Chief, 23701 S. 655 Road, Grove, OK 74344, (918) Center. Center. 787–5452. Shawnee Tribe, Honorable Ron Sparkman, Chairman, P.O. 739,275 Public Facility—Community Rehabilitation of Social Services Re- Box 189, Miami, OK 74355, (918) 542–2441. Center. source Center. Spirit Lake Housing Corporation, Douglas Yankton, Execu- 900,000 Housing Rehabilitation ...... Rehabilitation of 21 rental units in an tive Director, P.O. Box 187, Fort Totten, ND 58335, (701) elderly housing complex. 766–4131. St. Croix Chippewa Indians of Wisconsin, Stuart Bearheart, 600,000 Housing Rehabilitation ...... Rehabilitation of 22 units. 24663 Angeline Ave, Webster, WI 54893, (715) 349– 2195. Tunica-Biloxi Tribe of Louisiana, Honorable Earl J. Barbry 779,279 Public Facility—Community Construction of a social services build- Sr., Chairman, P.O. Box 1589, Markville, LA 71351, Center. ing. (318) 253–9767. United Keetoowah Band of Cherokee Indians of Oklahoma, 800,000 Public Facility—Community Expansion of a Museum/Cultural Cen- Honorable George Wickliffe, Chief, P.O. Box 746, Tahle- Center. ter. quah, OK 74465, (918) 456–5126. Ute Indian TDHE, Emmett Duncan, Executive Director, 900,000 Housing Rehabilitation...... Rehabilitation of 23 single family P.O. Box 250, Fort Duchesne, UT 84026, (435) 722– homes. 4656. Village of Venetie, Joshua Roberts, First Chief, P.O. Box 540,000 Housing Construction ...... Construction of 2 homes. 81119, Venetie, AK 99781, (907) 849–8212. Wells Indian Colony Band of Te-Moak Tribe of Western 605,000 Economic Development...... Design and construction of a Small Shoshone, Honorable Paula Salazar, Chairperson, P.O. Business Development Incubator. Box 809, Wells, NV 89835, (775) 752–3045. White Earth Band of the Minnesota Chippewa Tribe, Mi- 600,000 Public Facility—Community Health facility addition. chael Triplett, P.O. Box 418, White Earth, MN 56591, Center. (218) 983–3285. Wyandotte Nation, Honorable Billy Friend, Chief, 64700 E 800,000 Public Facility—Community Housing services center. Highway 60, Wyandotte, OK 74370, (918) 678–2297. Center. Yakama Nation Housing Authority, James Berg, P.O. Box 500,000 Public Facility—Infrastructure Construction of a new hydro well with 156, Wapato, WA 98951, (509) 877–6171. pump station. Yurok Tribe, Honorable Thomas O’Rourke Sr., Chair- 605,000 Public Facility—Community Purchase of the Yurok Tribe Early person, P.O. Box 1027, Klamath, CA 95548, (707) 482– Center. Education and Family Resource 1350. Center.

[FR Doc. 2012–27471 Filed 11–8–12; 8:45 am] and Urban Development, 451 Seventh determined suitable or unsuitable this BILLING CODE 4210–67–P Street SW., Room 7262, Washington, DC week. 20410; telephone (202) 402–3970; TTY Dated: November 1, 2012. number for the hearing- and speech- Ann Marie Oliva, DEPARTMENT OF HOUSING AND impaired (202) 708–2565, (these URBAN DEVELOPMENT telephone numbers are not toll-free), or Deputy Assistant Secretary for Special Needs (Acting). [Docket No. FR–5601–N–44] call the toll-free Title V information line at 800–927–7588. [FR Doc. 2012–27089 Filed 11–8–12; 8:45 am] Federal Property Suitable as Facilities BILLING CODE 4210–67–P To Assist the Homeless SUPPLEMENTARY INFORMATION: In accordance with the December 12, 1988 AGENCY: Office of the Assistant court order in National Coalition for the Secretary for Community Planning and Homeless v. Veterans Administration, Development, HUD. No. 88–2503–OG (D.D.C.), HUD ACTION: Notice. publishes a Notice, on a weekly basis, identifying unutilized, underutilized, SUMMARY: This Notice identifies unutilized, underutilized, excess, and excess and surplus Federal buildings surplus Federal property reviewed by and real property that HUD has HUD for suitability for possible use to reviewed for suitability for use to assist assist the homeless. the homeless. Today’s Notice is for the FOR FURTHER INFORMATION CONTACT: purpose of announcing that no Juanita Perry, Department of Housing additional properties have been

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DEPARTMENT OF THE INTERIOR Comment Submission Plants Committees), and make Comments should be submitted by recommendations for the improved Fish and Wildlife Service one of the following methods: effectiveness of CITES. Any country that • Federal eRulemaking Portal: http:// is a Party to CITES may propose [Docket No. FWS–R9–IA–2011–0087; 96300– www.regulations.gov. Follow the amendments to Appendices I and II, 1671–0000 FY12 R4] instructions for submitting comments resolutions, decisions, and agenda items on Docket No. FWS–R9–IA–2011–0087. for consideration by all the Parties at the Conference of the Parties to the • U.S. mail or hand-delivery: Public meetings. Convention on International Trade in Comments Processing, Attn: FWS–R9– This is our fifth in a series of Federal Endangered Species of Wild Fauna IA–2011–0087; Division of Policy and Register notices that, together with an and Flora (CITES); Sixteenth Regular Directives Management; U.S. Fish and announced public meeting, provide you Meeting; Provisional Agenda; Wildlife Service; 4401 N. Fairfax Drive, with an opportunity to participate in the Announcement of Public Meeting MS 2042–PDM; Arlington, VA 22203. development of the U.S. negotiating We will not consider comments sent positions for the sixteenth regular AGENCY: Fish and Wildlife Service, by email or fax, or to an address not meeting of the Conference of the Parties Interior. listed in the ADDRESSES section. to CITES (CoP16). We published our ACTION: Notice. Comments and materials we receive in first CoP16-related Federal Register response to this notice will be posted for notice on June 14, 2011 (76 FR 34746), SUMMARY: The United States, as a Party public inspection on http:// in which we requested information and to the Convention on International www.regulations.gov and will be recommendations on species proposals Trade in Endangered Species of Wild available by appointment, between 8:00 for the United States to consider Fauna and Flora (CITES), will attend the a.m. and 4:00 p.m., Monday through submitting for consideration at CoP16, sixteenth regular meeting of the Friday, except Federal holidays, at and described our approach in Conference of the Parties to CITES either the Division of Management determining which species proposals to (CoP16) in Bangkok, Thailand, during Authority or the Division of Scientific consider submitting. We published our March 3 to15, 2013. Currently, the Authority. second such Federal Register notice on United States is developing its FOR FURTHER INFORMATION CONTACT: For November 7, 2011 (76 FR 68778), in negotiating positions on proposed information pertaining to resolutions, which we requested information and resolutions, decisions, and amendments decisions, and agenda items, contact: recommendations on proposed to the CITES Appendices (species Robert R. Gabel, Chief, Division of resolutions, decisions, and agenda items proposals), as well as other agenda Management Authority; telephone 703– for the United States to consider items that have been submitted by other 358–2095; facsimile 703–358–2298. For submitting for consideration at CoP16, Party countries, the permanent CITES information pertaining to species described our approach in determining committees, and the CITES Secretariat proposals, contact: Rosemarie Gnam, which proposed resolutions, decisions, for consideration at CoP16. With this Chief, Division of Scientific Authority; and agenda items to consider notice we announce the provisional telephone 703–358–1708; fascsimile submitting, and provided preliminary agenda for CoP16, solicit your 703–358–2276. information on how to request approved comments on the items on the SUPPLEMENTARY INFORMATION: observer status for non-governmental provisional agenda, and announce a organizations that wish to attend the public meeting to discuss the items on Background meeting. In our third CoP16-related the provisional agenda. The Convention on International Federal Register notice, published on DATES: Public meeting: The public Trade in Endangered Species of Wild April 11, 2012 (77 FR 21798), we meeting will be held on December 5, Fauna and Flora, hereinafter referred to requested public comments and 2012, at 1:30 p.m. Comment submission: as CITES or the Convention, is an information on species proposals that In developing the U.S. negotiating international treaty designed to control the United States was considering positions on proposed resolutions, and regulate international trade in submitting for consideration at CoP16; decisions, and species proposals, and certain animal and plant species that are and in our fourth such notice, published other agenda items submitted by other now or potentially may become on June 21, 2012 (77 FR 37433), we Party countries, the permanent CITES threatened with extinction. These requested public comments and committees, and the CITES Secretariat species are listed in Appendices to information on proposed resolutions, for consideration at CoP16, we will CITES, which are available on the decisions, and agenda items that the consider written information and CITES Secretariat’s Web site at http:// United States was considering comments you submit if we receive www.cites.org/eng/app/index.php. submitting for consideration at CoP16, them by January 8, 2013. Currently, 176 countries, including the and provided more information on how United States, are Parties to CITES. The to request approved observer status for ADDRESSES: Convention calls for regular biennial non-governmental organizations that Public Meeting meetings of the Conference of the wish to attend the meeting. A link to the Parties, unless the Conference of the complete list of those Federal Register The public meeting will be held in the Parties decides otherwise. At these notices, along with information on U.S. Sidney Yates Auditorium at the Main meetings, the Parties review the preparations for CoP16, can be found at Interior Building at 18th and C Streets implementation of CITES, make http://www.fws.gov/international/cites/ NW., Washington, DC. Directions to the provisions enabling the CITES cop16/. You may obtain additional building can be obtained by contacting Secretariat in Switzerland to carry out information on those Federal Register the Division of Management Authority its functions, consider amendments to notices from the following sources: For (see FOR FURTHER INFORMATION CONTACT). the lists of species in Appendices I and information on proposed resolutions, For more information about the meeting, II, consider reports presented by the decisions, and agenda items, contact the see ‘‘Announcement of Public Meeting’’ Secretariat and the permanent CITES Division of Management Authority, U.S. under SUPPLEMENTARY INFORMATION. committees (Standing, Animals, and Fish and Wildlife Service, 4401 N.

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Fairfax Drive, Room 212, Arlington, VA cop16/, and look for the link to the live The dependent resurvey of a portion 22203; and for information on species feed. of the West Boundary, a portion of the proposals, contact the Division of subdivisional lines, and the subdivision Future Actions Scientific Authority, U.S. Fish and of Sections 18 and 19, in Township 11 Wildlife Service, 4401 N. Fairfax Drive, Through an additional notice and North, Range 11 East, of the Choctaw Room 110, Arlington, VA 22203. Our Web site posting in advance of CoP16, Meridian, in the State Mississippi, and regulations governing this public we will inform you about tentative U.S. was accepted September 20, 2012. process are found in 50 CFR 23.87. negotiating positions on species We will place copies of the plats we On October 4, 2012, the United States proposals, proposed resolutions, described in the open files. They will be submitted to the CITES Secretariat, for proposed decisions, and agenda items available to the public as a matter of consideration at CoP16, its species that were submitted by other Party information. proposals, proposed resolutions, countries, the permanent CITES If BLM receives a protest against a proposed decisions, and other agenda committees, and the CITES Secretariat survey, as shown on the plat, prior to items. These documents are available on for consideration at CoP16. the date of the official filing, we will our Web site at http://www.fws.gov/ Author: The primary author of this stay the filing pending our international/cites/cop16/. notice is Mark Bellis, Division of consideration of the protest. Management Authority; under the We will not officially file the plats Announcement of Provisional Agenda authority of the U.S. Endangered for CoP16 until the day after we have accepted or Species Act of 1973, as amended (16 dismissed all protests and they have The provisional agenda for CoP16 is U.S.C. 1531 et seq.). become final, including decisions on currently available on the CITES Dated: October 24, 2012. appeals. Secretariat’s Web site at http:// Rowan W. Gould, www.cites.org/eng/cop/16/doc/ Dated: November 2, 2012. index.php. The working documents Director. Dominica Van Koten, associated with the items on the [FR Doc. 2012–27385 Filed 11–8–12; 8:45 am] Chief Cadastral Surveyor. provisional agenda, including proposed BILLING CODE 4310–55–P [FR Doc. 2012–27347 Filed 11–8–12; 8:45 am] resolutions, proposed decisions, and BILLING CODE 4310–GJ–P discussion documents, are also available on the Secretariat’s Web site. To view DEPARTMENT OF THE INTERIOR the working document associated with a Bureau of Land Management DEPARTMENT OF THE INTERIOR particular agenda item, access the provisional agenda at the above Web [LLES956000.L19100000.BK0000. Bureau of Land Management LRCMM0E04175] site, locate the particular agenda item, [LLNVW01000 L12200000.EA0000 241A; and click on the document link for that Eastern States: Filing of Plats of MO# 4500033780; 12–08807; TAS: 14X1106] agenda item in the column entitled Survey; Mississippi ‘‘Document.’’ Finally, the species Notice of Proposed Supplementary proposals that will be considered at AGENCY: Bureau of Land Management, Rules on Public Land in Water Canyon, CoP16 are available on the Secretariat’s Interior. Humboldt County, NV Web site. Proposals for amendment of ACTION: Notice. AGENCY: Bureau of Land Management, Appendices I and II can be accessed at Interior. the web address given above. We look SUMMARY: The Bureau of Land forward to receiving your comments on Management (BLM) will file the plats of ACTION: Proposed supplementary rules. the items on the provisional agenda. survey of the lands described below in the BLM-Eastern States office in SUMMARY: The Bureau of Land Announcement of Public Meeting Springfield, Virginia, 30 calendar days Management (BLM) is proposing We will hold a public meeting to from the date of publication in the supplementary rules relating to discuss with you the items on the Federal Register. camping, the discharge of firearms, and the use of motor vehicles, to protect provisional agenda for CoP16. The FOR FURTHER INFORMATION CONTACT: public safety and resources on public public meeting will be held on the date Bureau of Land Management-Eastern land within the Water Canyon specified in the DATES section and at the States, 7450 Boston Boulevard, Recreation Area. These proposed address specified in the ADDRESSES Springfield, Virginia 22153. Attn: supplementary rules would include section. You can obtain directions to the Dominica Van Koten. Persons who use limitations and restrictions included building by contacting the Division of a telecommunications device for the within the decisions of the Water Management Authority (see the FOR deaf (TDD) may call the Federal Canyon Recreation Area Management FURTHER INFORMATION CONTACT section Information Relay Service (FIRS) at 1– Plan, Environmental Assessment (EA), above). Please note that the Sidney 800–877–8339 to contact the above Decision Record, and Cooperative Yates Auditorium is accessible to the individual during normal business Management Agreement approved handicapped and all persons planning hours. The FIRS is available 24 hours a August 15, 1997, and the Water Canyon to attend the meeting will be required to day, 7 days a week, to leave a message Implementation Plan Amendment EA present photo identification when or question with the above individual. signed August 2005. entering the building. Persons who plan You will receive a reply during normal to attend the meeting and who require business hours. DATES: Comments on the proposed supplementary rules must be received interpretation for the hearing impaired SUPPLEMENTARY INFORMATION: These or postmarked by January 8, 2013 to be must notify the Division of Management surveys were requested by the Bureau of assured consideration. Authority by November 21, 2012. For Indian Affairs, Eastern Regions. those who cannot attend the public The lands surveyed are: ADDRESSES: Please mail comments to meeting but are interested in watching Michael Truden, Winnemucca District, via live stream please go to our Web site Choctaw Meridian, Mississippi Humboldt River Field Office, 5100 E http://www.fws.gov/international/cites/ T. 11 N., R. 11 E. Winnemucca Boulevard, Winnemucca,

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Nevada 89445; or email comments to which is approximately 131 acres, is These objectives, which can be found in [email protected], Attn: ‘‘Water managed under moderate development the 2005 Implementation Plan, include: Canyon.’’ actions organized around the lowland Protecting surface and subsurface water and riparian areas of the Water Canyon quality within the watershed; providing FOR FURTHER INFORMATION CONTACT: Joey Carmosino, Winnemucca District, Recreation Area, allowing for more recreational opportunities; preserving developed recreation in the form of broad-leafed trees, high quality riparian Humboldt River Field Office at 775– established campgrounds, facilities, and areas, and grassy meadows; and 623–1771 or email: [email protected]. trails. The Zone 2 upland area of providing for a diversity of wildlife Persons who use a telecommunications approximately 2,579 acres is managed habitats. device for the deaf (TDD) may call the under an emphasis for more dispersed To achieve these objectives, the BLM Federal Information Relay Service and undeveloped recreational evaluated a series of alternative (FIRS) at 1–800–877–8339 to contact the opportunities. The BLM has completed proposals that prescribed different above individual during normal two site-specific land use plans for the allowable uses of the planning area and business hours. The FIRS is available 24 Water Canyon Recreation Area: defined other management actions to hours a day, 7 days a week, to leave a • The Water Canyon Management reach these desired outcomes. The message or question with the above Plan, Cooperative Management evaluation process led to a series of individual. You will receive a reply Agreement, Environmental Assessment, management decisions that emphasized during normal business hours. and Decision Record (August 15, 1997); a combination of moderate and low SUPPLEMENTARY INFORMATION: and development actions organized around • I. Public Comment Procedures The Water Canyon Implementation the division of the planning area into II. Background Plan Amendment, Environmental lowland (Zone 1) and upland (Zone 2) III. Discussion of the Proposed Assessment, and Decision Record areas. Supplementary Rules (November 16, 2005). IV. Procedural Matters These supplementary rules would III. Discussion of the Proposed V. Proposed Supplementary Rules affect public lands identified as Zone 1 Supplementary Rules I. Public Comment Procedures of the Water Canyon Recreational Area. In the preparation of the two EAs, the Zone 1, which is identified in the Water BLM sought public review of three Written comments on the proposed Canyon Management Plan and EA, and alternatives in the Management Plan supplementary rules should be specific, the Cooperative Management and two alternatives in the be confined to issues pertinent to the Agreement, is the portion of the Canyon Implementation Plan. These EAs proposed supplementary rules, and that receives the most recreational use. discuss specific management actions explain the reason for any Zone 1 is a fenced corridor of public that restrict certain activities and define recommended change. Where possible, land within Township 35 North, Range allowable uses. The proposed comments should reference the specific 38 East, Mount Diablo Meridian, supplementary rules would implement section or paragraph of the proposal through portions of sections 2, 11, and these management actions within Zone which the comment is addressing. The 12, in Humboldt County, Nevada. The 1 of the Water Canyon Recreation Area. BLM is not obligated to consider or Zone 1 fenced corridor is of variable The proposed supplementary rules include in the Administrative Record width perpendicular to the centerline of would: for the final supplementary rules Water Canyon Road with an overall 1. Limit camping within Zone 1 of the comments either postmarked or width average of approximately 600 feet Water Canyon Recreation Area to no electronically dated after the deadline or and runs approximately 1.8 miles in more than 3 consecutive nights in a 30- delivered to an address other than the length along Water Canyon Road, in day period. Water Canyon is a popular address listed above (See ADDRESSES). Township 36 North Range 38 East, parts recreational spot for the local Comments (including names, street of sections 2, 11 and 12. community of Winnemucca. Limiting addresses, and other contact A map of the area is available at the the length of camping would increase information of respondents) will be Winnemucca District, Humboldt River the opportunities for multiple available for public review at the Field Office at the address shown in the community residents to enjoy the Winnemucca District Office, 5100 E. ADDRESSES section, above. campground and enhance the Winnemucca Boulevard, Winnemucca, The proposed supplementary rules experience of day users. Nevada. Before including your address, are necessary to help the BLM achieve 2. Prohibit the discharge of any phone number, email address, or other management objectives and implement firearm in Zone I. This rule is proposed personal identifying information in your decisions in the Management Plan, as a safety measure. The City of comment, you should be aware that associated EA, and Decision Record, Winnemucca, population 7,400, and your entire comment—including your Cooperative Management Agreement Grass Valley, population 1,160, are in personal identifying information—may approved August 15, 1997, and the close proximity to Zone 1, which be made publicly available at any time. Implementation Plan signed August receives more than 50,000 visitors While you can ask us in your comment 2005 and to increase public safety. annually. to withhold your personal identifying The Cooperative Management 3. All motor vehicles must not exceed information from public review, we Agreement for Water Canyon was a the posted speed limit of 20 miles per cannot guarantee that we will be able to collaborative effort undertaken among hour on the main access/canyon road in do so. the BLM, the Nevada Department of Zone I. This speed limit is proposed Wildlife, Humboldt County, the City of because there have been numerous II. Background Winnemucca, and the public to elicit accidents along the main access/canyon The Water Canyon Recreation Area is concerns, define issues, and develop a road in Zone 1. These accidents have 4 miles southeast of Winnemucca, set of desired future conditions for the primarily been a result of excess speed Nevada. Water Canyon is managed by planning area. The outcome of this due to no posted or enforceable speed the BLM Winnemucca District, process was the development of a set of limit. Humboldt River Field Office with objectives intended to guide subsequent 4. All motor vehicles are restricted to Recreation Management Zones. Zone 1, management actions within the canyon. travel only on the main access/canyon

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road in Zone 1. This restriction is National Environmental Policy Act Unfunded Mandates Reform Act proposed to further protect the wetland These proposed supplementary rules The proposed supplementary rules and riparian areas that are in close provide for enforcement of decisions would not impose an unfunded proximity to the main access/canyon made in: mandate on State, local, or tribal road in Zone 1. • The Water Canyon Management governments in the aggregate, or on the IV. Procedural Matters Plan, Cooperative Management private sector of more than $100 million per year; nor would they have a Regulatory Planning and Review Agreement, EA, and Decision Record; and significant or unique effect on small (Executive Orders 12866 and 13563) governments. The proposed • The Water Canyon Implementation supplementary rules would have no The proposed supplementary rules Plan Amendment, Environmental effect on governmental or tribal entities would not constitute a significant Assessment, and Decision Record and would impose no requirements on regulatory action and are not subject to (November 16, 2005). review by the Office of Management and any of these entities. The proposed During the National Environmental supplementary rules would merely Budget under Executive Order 12866. Policy Act process for each plan, many establish rules of conduct for public use The proposed supplementary rules proposed actions were fully analyzed, of a limited area of public lands and would not have an annual effect of $100 including these proposed would not affect tribal, commercial, or million or more on the economy. They supplementary rules. The pertinent business activities of any kind. would not adversely affect in a material analysis and rationale can be found in Therefore, the BLM is not required to way the economy, productivity, the Management Plan, inclusive of the prepare a statement containing the competition, jobs, the environment, EA, Decision Record, and Cooperative information required by the Unfunded public health, or safety, or State, local, Management Agreement approved Mandates Reform Act (2 U.S.C. 1531 et or tribal governments or communities. August 15, 1997, and the seq.). The proposed supplementary rules Implementation Plan EA signed in 2005. Executive Order 12630, Governmental would not create a serious inconsistency The EAs mentioned above are available Actions and Interference With or otherwise interfere with an action for review in the BLM administrative Constitutionally Protected Property taken or planned by another agency. record at the address specified in the The proposed supplementary rules Rights (Takings) ADDRESSES section. would not materially alter the budgetary The BLM reviewed the EAs and found The proposed supplementary rules effects of entitlements, grants, user fees, that the proposed supplementary rules would not have significant takings or loan programs or the rights or would not constitute a major Federal implications, nor would they be capable obligations of their recipients; nor action significantly affecting the quality of interfering with Constitutionally would they raise novel legal or policy of the human environment under the protected property rights. The proposed issues. The proposed supplementary National Environmental Policy Act supplementary rules would merely rules merely would be rules of conduct (NEPA) Section 102(2)(C), 42 U.S.C. establish rules of conduct for public use for public use of a limited area of public 4332(2)(C). of a limited area of public lands and lands. would not affect anyone’s property Regulatory Flexibility Act Clarity of the Regulations rights. Therefore, the BLM has Congress enacted the Regulatory determined that these rules would not Executive Order 12866 requires each Flexibility Act (RFA) of 1980, as cause a taking of private property or agency to write regulations that are amended (5 U.S.C. 601–612) to ensure require preparation of a takings simple and easy to understand. The that government regulations do not assessment under this Executive Order. BLM invites your comments on how to unnecessarily or disproportionately Executive Order 13132, Federalism make the proposed supplementary rules burden small entities. The RFA requires These proposed supplementary rules easier to understand, including answers a regulatory flexibility analysis if a rule to questions such as the following: would not have a substantial direct would have a significant economic effect on the states, the relationship 1. Are the requirements in the impact, either detrimental or beneficial, between the national government and proposed supplementary rules clearly on a substantial number of small the states, nor the distribution of power stated? entities. The proposed supplementary and responsibilities among the various 2. Do the proposed supplementary rules would merely establish rules of levels of government. These proposed rules contain technical language or conduct for public use of a limited area supplementary rules would not come jargon that interferes with their clarity? of public lands. Therefore, the BLM has into conflict with any State law or 3. Does the format of the proposed determined under the RFA that the regulation. Therefore, under Executive supplementary rules (grouping and proposed supplementary rules would Order 13132, the BLM has determined order of sections, use of headings, not have a significant economic impact that these proposed supplementary paragraphing, etc.) aid or reduce clarity? on a substantial number of small rules would not have sufficient entities. 4. Is the description of the proposed Federalism implications to warrant supplementary rules in the Small Business Regulatory Enforcement preparation of a Federalism Assessment. SUPPLEMENTARY INFORMATION section of Fairness Act Executive Order 12988, Civil Justice this preamble helpful in understanding The proposed supplementary rules Reform the supplementary rules? How could are not a ‘‘major rule’’ as defined under Under Executive Order 12988, the this description be more helpful in 5 U.S.C. 804(2). The proposed BLM has determined that these making the proposed supplementary supplementary rules would merely proposed supplementary rules would rules easier to understand? establish rules of conduct for public use not unduly burden the judicial system Please send any comments you have on of a limited area of public lands and and that they would meet the the clarity of the rule to the address would not affect commercial or business requirements of Sections 3(a) and 3(b) specified in the ADDRESSES section. activities of any kind. (2) of the Order.

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Executive Order 13175, Consultation activities within Zone 1 of the Water implementing the provisions of the National and Coordination With Indian Tribal Canyon Recreation Area, which is Environmental Policy Act (NEPA) of 1969, as Governments comprised of public lands administered amended (42 U.S.C. 4321 et seq.). In accordance with Executive Order by the BLM near Winnemucca, Nevada. SUMMARY: BOEM has prepared a Draft 13175, the BLM has determined that 2. These supplementary rules are in Supplemental EIS for oil and gas lease these proposed supplementary rules effect on a year-round basis. sales tentatively scheduled in 2013 and 3. Camping in Zone I is limited to no would not include policies that have 2014 in the WPA and CPA offshore the more than 3 consecutive nights in a 30- tribal implications. There are no tribal States of Texas, Louisiana, Mississippi, day period. and Alabama. This Draft Supplemental implications associated with the 4. The discharge of any firearm in proposed rule. The proposed rule EIS updates the environmental and Zone I is prohibited. socioeconomic analyses for proposed applies only to the narrow Zone 1 area, 5. All motor vehicles must not exceed which is within the larger area of Water WPA Lease Sale 233 and proposed CPA the posted speed limit of 20 miles per Lease Sale 231, which was completed in Canyon. There are no tribal lands in the hour on the main access/canyon road in vicinity. July 2012, as part of the 2012–2017 Zone I. Multisale EIS. The 2012–2017 Multisale Paperwork Reduction Act 6. All motor vehicles are restricted to EIS covers planning areas in the Gulf of travel only on the main access/canyon Mexico OCS Oil and Gas Lease Sales: These proposed supplementary rules road in Zone 1. would not directly provide for any Western Planning Area Lease Sales 229, information collection that the Office of Exemptions 233, 238, 246, and 248; and Central Management and Budget must approve The following persons are exempt Planning Area Lease Sales 227, 231, under the Paperwork Reduction Act, 44 from these supplementary rules: Any 235, 241, and 247. U.S.C. 3501 et seq. Any information Federal, State, local or military persons SUPPLEMENTARY INFORMATION: BOEM collection that may result from Federal acting within the scope of their duties; developed this Draft Supplemental EIS criminal investigations or prosecution and members of an organized rescue or for proposed WPA Lease Sale 233 and conducted under these proposed firefighting force in performance of an proposed CPA Lease Sale 231 to supplementary rules is exempt from the official duty. consider new information made provisions of the Paperwork Reduction available since completion of the 2012– Act of 1995, 44 U.S.C. 3518(c)(1). Penalties 2017 Multisale EIS and to consider, among other things, new information in Author Under Section 303(a) of the Federal Land Policy and Management Act (43 light of the Deepwater Horizon event. The principal author of these U.S.C. 1733(a)) and 43 CFR 8360.0–7, This Draft Supplemental EIS provides proposed supplementary rules is Joey any person who violates any of these updates on the baseline conditions and Carmosino, Humboldt River Field Office supplementary rules may be tried before potential environmental effects of oil Recreation Planner, Winnemucca a United States Magistrate and fined no and natural gas leasing, exploration, District, 5100 E. Winnemucca more than $1,000 or imprisoned for no development, and production in the Boulevard, Winnemucca, Nevada 89445. more than 12 months, or both. Such WPA and CPA. BOEM conducted an V. Proposed Supplementary Rules violations may also be subject to the extensive search for new information in enhanced fines provided for by 18 consideration of the Deepwater Horizon For the reasons stated in the preamble U.S.C. 3571. In accordance with 43 CFR event, reviewing scientific journals, and under the authorities for 8365.1–7, State or local officials may available scientific data, and supplementary rules found at 43 U.S.C. also impose penalties for violations of information from academic institutions 1740 and 43 CFR 8365.1–6, the BLM Nevada law. and Federal, State, and local agencies. Nevada State Director proposes BOEM also interviewed personnel from supplementary rules for public lands Amy Lueders, academic institutions and Federal, managed by the BLM in Nevada, to read Bureau of Land Management, State Director, State, and local agencies. BOEM has as follows: Nevada. examined the potential impacts of [FR Doc. 2012–27402 Filed 11–8–12; 8:45 am] Proposed Supplementary Rules for routine activities and accidental events, Zone 1 of the Water Canyon Recreation BILLING CODE 4310–HC–P and the proposed lease sales’ Area incremental contribution to the cumulative impacts on environmental Definitions DEPARTMENT OF THE INTERIOR and socioeconomic resources. Firearm means any weapon or any Bureau of Ocean Energy Management Draft Supplemental EIS Availability: implement designed to or that may be BOEM has printed and will distribute a converted to expel a projectile; Gulf of Mexico (GOM), Outer limited number of paper copies of the including, but not limited to, by the Continental Shelf (OCS), Western Draft Supplemental EIS. In keeping with action of an explosive, a compressed gas Planning Area (WPA) Lease Sale 233 the Department of the Interior’s mission or spring powered pistol or rifle, bow and Central Planning Area (CPA) Lease of protecting natural resources, and to and arrow, crossbow, blowgun, spear Sale 231, Oil and Gas Lease Sales limit costs while ensuring availability of gun, spear, sling shot, or irritant gas the document to the public, BOEM will device. AGENCY: Bureau of Ocean Energy primarily distribute digital copies of this Motor vehicle includes, but is not Management (BOEM), Interior. Draft Supplemental EIS on compact limited to, automobiles, motorcycles, ACTION: Notice of Availability (NOA) of discs. If you require a paper copy and all-terrain vehicles, and off-highway the Draft Supplemental Environmental copies are still available, BOEM will vehicles. Impact Statement (EIS) and Public provide one upon request. Meetings. You may request a copy of the Draft Supplementary Rules Supplemental EIS from the Bureau of 1. These supplementary rules apply, Authority: This NOA is published Ocean Energy Management, Gulf of except as specifically exempted, to pursuant to the regulations (40 CFR 1503) Mexico OCS Region, Public Information

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Office (GM 250G), 1201 Elmwood Park Supplemental EIS, you may contact Mr. Commission’s electronic docket (EDIS) Boulevard, Room 250, New Orleans, Gary D. Goeke, Bureau of Ocean Energy at http://edis.usitc.gov. Louisiana 70123–2394 (1–800–200– Management, Gulf of Mexico OCS SUPPLEMENTARY INFORMATION: Effective GULF). Region, Office of Environment You may download or view the Draft (GM623E), 1201 Elmwood Park May 21, 2012, the Commission Supplemental EIS on BOEM’s Internet Boulevard, New Orleans, Louisiana established a schedule for the conduct Web site at http://www.boem.gov/ 70123–2394 or by email at LS_233– of these five-year reviews (77 FR 31877, Environmental-Stewardship/ [email protected]. You may also May 30, 2012). As noted in the Environmental-Assessment/NEPA/ contact Mr. Goeke by telephone at (504) Commission’s original scheduling nepaprocess.aspx. 736–3233. notice, ‘‘The Commission has Several libraries along the Gulf Coast determined to exercise its authority to Public Disclosure of Names and have been sent copies of the Draft extend the review period by up to 90 Addresses Supplemental EIS. To find out which days pursuant to 19 U.S.C. libraries have copies of the Draft Before including your address, phone 1675(c)(5)(B).’’ The hearing in Supplemental EIS for review, you may number, email address, or other connection with these reviews, contact BOEM’s Public Information personal identifying information in your originally scheduled for November 1, Office (phone number and address comment, please be advised that your 2012, was subsequently cancelled by the above) or visit BOEM’s Internet Web site entire comment, including your Chairman due to the severity and at http://www.boem.gov/Environmental- personal identifying information, may duration of Hurricane Sandy. The Stewardship/Environmental- be made publicly available at any time. Commission, therefore, is rescheduling Assessment/NEPA/nepaprocess.aspx. While you can ask us in your comment the hearing and revising the remainder Comments: Federal, state, and local to withhold from public review your of its schedule in the five-year reviews. government agencies and other personal identifying information, we Prehearing briefs have already been interested parties are requested to send cannot guarantee that we will be able to filed in these reviews and there is no their written comments on the Draft do so. need to refile or to supplement those Supplemental EIS in one of the Dated: November 6, 2012. briefs. following two ways: Tommy P. Beaudreau, The Commission’s hearing on the 1. In an envelope labeled ‘‘Comments Director, Bureau of Ocean Energy subject reviews will be held at the U.S. on the Draft Supplemental EIS’’ and Management. International Trade Commission mailed (or hand carried) to Mr. Gary D. [FR Doc. 2012–27519 Filed 11–8–12; 8:45 am] Building at 9:30 a.m. on January 9, 2013. Goeke, Chief, Regional Assessment BILLING CODE 4310–MR–P Any revisions to previously submitted Section, Office of Environment (GM hearing appearance requests, which 623E), Bureau of Ocean Energy were originally due on or before October Management, Gulf of Mexico OCS 25, 2012, should be filed in writing with Region, 1201 Elmwood Park Boulevard, INTERNATIONAL TRADE the Secretary to the Commission on or New Orleans, Louisiana 70123–2394. COMMISSION before January 2, 2013. Witness hearing 2. To the following BOEM email [Investigation Nos. 701–TA–350 and 731– testimony must be filed no later than address: LS_233–[email protected]. TA–616 and 618 (Third Review)] January 4, 2013. The deadline for filing Comments should be submitted no later posthearing briefs is January 18, 2013. than December 24, 2012. Corrosion-Resistant Carbon Steel Flat In addition, any person who has not Public Meetings: BOEM also will hold Products From Germany and Korea; entered an appearance as a party to the public meetings to obtain comments Revised Schedule for the Subject reviews may submit a written statement regarding the Draft Supplemental EIS. Reviews These meetings are scheduled as of information pertinent to the subject of follows: AGENCY: United States International the reviews on or before January 18, • Houston, Texas: December 03, Trade Commission. 2013. On February 6, 2013, the 2012, Houston Airport Marriott at ACTION: Notice. Commission will make available to George Bush Intercontinental, 18700 parties all information on which they John F. Kennedy Boulevard, Houston, DATES: Effective Date: November 2, have not had an opportunity to Texas 77032, beginning at 1:00 p.m. 2012. comment. Parties may submit final comments on this information on or CST; FOR FURTHER INFORMATION CONTACT: before February 8, 2013, but such final • New Orleans, Louisiana: December Mary Messer (202–205–3193), Office of comments must not contain new factual 04, 2012, Bureau of Ocean Energy Investigations, U.S. International Trade information and must otherwise comply Management, 1201 Elmwood Park Commission, 500 E Street SW., with section 207.68 of the Commission’s Boulevard, New Orleans, Louisiana Washington, DC 20436. Hearing- rules. 70123, beginning at 1:00 p.m. CST; impaired persons can obtain • Gulfport, Mississippi: December 05, information on this matter by contacting Authority: These reviews are being 2012, Courtyard by Marriott Gulfport the Commission’s TDD terminal on 202– conducted under authority of title VII of the Beachfront MS Hotel, 1600 East Beach 205–1810. Persons with mobility Tariff Act of 1930; this notice is published Boulevard, Gulfport, Mississippi 39501, impairments who will need special pursuant to section 207.62 of the beginning at 1:00 CST; assistance in gaining access to the Commission’s rules. • Mobile, Alabama: December 06, Commission should contact the Office Issued: November 5, 2012. 2012, Five Rivers—Alabama’s Delta of the Secretary at 202–205–2000. By order of the Commission. Resource Center, 30945 Five Rivers General information concerning the Boulevard, Spanish Fort, Alabama Commission may also be obtained by Lisa R. Barton, 36527, beginning at 1:00 p.m. CST. accessing its internet server (http:// Acting Secretary to the Commission. FOR FURTHER INFORMATION CONTACT: For www.usitc.gov). The public record for [FR Doc. 2012–27371 Filed 11–8–12; 8:45 am] more information on the Draft these reviews may be viewed on the BILLING CODE 7020–02–P

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INTERNATIONAL TRADE INTERNATIONAL TRADE DEPARTMENT OF JUSTICE COMMISSION COMMISSION Notice of Lodging of Proposed Consent Decree Under The [USITC SE–12–031] [USITC Se–12–030] Comprehensive Environmental Government In The Sunshine Act Government in the Sunshine Act Response, Compensation, and Liability Meeting Notice Meeting Notice Act On November 5, 2012, the Department AGENCY HOLDING THE MEETING: United AGENCY HOLDING THE MEETING: United of Justice lodged a proposed consent States International Trade Commission. States International Trade Commission. decree with the United States District Court for the Western District of TIME AND DATE: November 15, 2012 at TIME AND DATE: November 14, 2012 at Washington in the lawsuit entitled 9:30 a.m. 11:00 a.m. United States v. Index Sportsmen, Inc. PLACE: Room 101, 500 E Street SW., PLACE: Room 101, 500 E Street SW., (aka Index Sportsmen Club), Civil Washington, DC 20436, Telephone: Washington, DC 20436, Telephone: Action No. 12–1949. (202) 205–2000. (202) 205–2000. The United States filed this CERCLA STATUS: Open to the public. lawsuit on behalf of the United States STATUS: Open to the public. Forest Service. The complaint requests MATTERS TO BE CONSIDERED: MATTERS TO BE CONSIDERED: recovery of costs that the United States 1. Agendas for future meetings: none incurred responding to releases of 1. Agendas for future meetings: none 2. Minutes hazardous substances at the Index 2. Minutes 3. Ratification List Shooting Range Site in the Mt. Baker- 3. Ratification List Snoqualmie National Forest near Index, 4. Vote in Inv. Nos. 701–TA–482–484 4. Vote in Inv. Nos. 701–TA–487 and Washington. Index Sportsmen, Inc., and 731–TA–1191–1194 operated a trap shooting range at the site 731–TA–1197 (Final) (Steel Wire (Final)(Circular Welded Carbon- for more than 60 years and the site is Garment Hangers from Taiwan). Quality Steel Pipe from India, contaminated with lead and arsenic The Commission is currently Oman, the United Arab Emirates, from discarded shot. The proposed scheduled to transmit its and Vietnam). The Commission is consent decree requires total payments determinations and Commissioners’ currently scheduled to transmit its of about $687,000, which includes opinions to the Secretary of determinations and Commissioners’ $600,000 to be paid by American States Commerce on or before November opinions to the Secretary of Insurance Company. In return, the 29, 2012. Commerce on or before November United States agrees not to sue the 28, 2012. 5. Outstanding action jackets: none defendant under sections 106 and 107(a) 5. Outstanding action jackets: none of CERCLA. In accordance with Commission The publication of this notice opens policy, subject matter listed above, not In accordance with Commission policy, subject matter listed above, not a period for public comment on the disposed of at the scheduled meeting, consent decree. Comments should be may be carried over to the agenda of the disposed of at the scheduled meeting, may be carried over to the agenda of the addressed to the Assistant Attorney following meeting. following meeting. General, Environment and Natural By order of the Commission. Resources Division, and should refer to By order of the Commission. Issued: November 7, 2012. United States v. Index Sportsmen, Inc., Issued: November 7, 2012. D.J. Ref. No. 90–11–3–10090. All William R. Bishop, William R. Bishop, comments must be submitted no later Supervisory Hearings and Information Supervisory Hearings and Information than thirty (30) days after the Officer. Officer. publication date of this notice. [FR Doc. 2012–27484 Filed 11–7–12; 11:15 am] [FR Doc. 2012–27483 Filed 11–7–12; 11:15 am] Comments may be submitted either by BILLING CODE 7020–02–P BILLING CODE 7020–02–P email or by mail:

To submit comments: Send them to:

By e-mail ...... [email protected]. By mail ...... Assistant Attorney General U.S. DOJ—ENRD P.O. Box 7611 Washington, D.C. 20044–7611.

During the public comment period, Please enclose a check or money order DEPARTMENT OF JUSTICE the consent decree may be examined for $5.75 (25 cents per page and downloaded at this Justice reproduction cost) payable to the United Drug Enforcement Administration Department Web site: http:// States Treasury. www.usdoj.gov/enrd/ Importer of Controlled Substances; Consent_Decrees.html. We will provide Robert E. Maher, Jr., Notice of Application, Fisher Clinical a paper copy of the Consent Decree Acting Deputy Section Chief, Environmental Services, Inc. upon written request and payment of Enforcement Section, Environment and reproduction costs. Please mail your Natural Resources Division. Pursuant to Title 21 Code of Federal request and payment to: Consent Decree [FR Doc. 2012–27436 Filed 11–8–12; 8:45 am] Regulations 1301.34(a), this is notice Library, U.S. DOJ—ENRD, P.O. Box BILLING CODE 4410–15–P that on August 20, 2012, Fisher Clinical 7611, Washington, DC 20044–7611. Services, Inc., 7554 Schantz Road,

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Allentown, Pennsylvania 18106, made July 26, 2012, 77 FR 43861, Boehringer Drug Schedule application to the Drug Enforcement Ingelheim Chemicals, Inc., 2820 N. Administration (DEA) for registration as Normandy Drive, Petersburg, Virginia Gamma Hydroxybutyric Acid I an importer of Tapentadol (9780), a 23805, made application by renewal to (2010). basic class of controlled substance listed the Drug Enforcement Administration Codeine-N-oxide (9053) ...... I Dihydromorphine (9145) ...... I in schedule II. (DEA) to be registered as an importer of The company plans to import the Morphine-N-oxide (9307) ...... I Phenylacetone (8501), a basic class of Amphetamine (1100) ...... II listed controlled substance to conduct controlled substance listed in schedule Methylphenidate (1724) ...... II clinical trials. II. Codeine (9050) II Dihydrocodeine II Any bulk manufacturer who is (9120). presently, or is applying to be, The company plans to import the listed controlled substance to bulk Oxycodone (9143) ...... II registered with DEA to manufacture Hydromorphone (9150) ...... II such basic class of controlled substance manufacture amphetamine. Hydrocodone (9193) ...... II listed in schedule II, which falls under No comments or objections have been Morphine (9300) ...... II the authority of section 1002(a)(2)(B) of received. DEA has considered the Oripavine (9330) ...... II the Act (21 U.S.C. 952(a)(2)(B)) may, in factors in 21 U.S.C. 823(a) and 952(a), Thebaine (9333) ...... II the circumstances set forth in 21 U.S.C. and determined that the registration of Oxymorphone (9652) ...... II Noroxymorphone (9668) ...... II 958(i), file comments or objections to Boehringer Ingelheim Chemicals, Inc., Alfentanil (9737) ...... II the issuance of the proposed registration to import the basic class of controlled Sufentanil (9740) ...... II and may, at the same time, file a written substance is consistent with the public Carfentanil (9743) ...... II request for a hearing on such interest and with United States Tapentadol (9780) ...... II application pursuant to 21 CFR obligations under international treaties, Fentanyl (9801) ...... II § 1301.43 and in such form as conventions, or protocols in effect on prescribed by 21 CFR § 1316.47. May 1, 1971. The company plans to manufacture Any such written comments or DEA has investigated Boehringer the listed controlled substances in bulk objections should be addressed, in Ingelheim, Inc., to ensure that the for distribution to its customers. quintuplicate, to the Drug Enforcement company’s registration is consistent Any other such applicant, and any Administration, Office of Diversion with the public interest. The person who is presently registered with Control, Federal Register Representative investigation has included inspection DEA to manufacture such substances, (ODL), 8701 Morrissette Drive, and testing of the company’s physical may file comments or objections to the Springfield, Virginia 22152; and must be security systems, verification of the issuance of the proposed registration filed no later than December 10, 2012. pursuant to 21 CFR 1301.33(a). This procedure is to be conducted company’s compliance with state and simultaneously with, and independent local laws, and a review of the Any such written comments or of, the procedures described in 21 CFR company’s background and history. objections should be addressed, in § 1301.34(b), (c), (d), (e), and (f). As Therefore, pursuant to 21 U.S.C. quintuplicate, to the Drug Enforcement noted in a previous notice published in 952(a) and 958(a), and in accordance Administration, Office of Diversion the Federal Register on September 23, with 21 CFR 1301.34, the above named Control, Federal Register Representative 1975, 40 FR 43745–46, all applicants for company is granted registration as an (ODL), 8701 Morrissette Drive, registration to import a basic class of importer of the basic class of controlled Springfield, Virginia 22152; and must be any controlled substances in schedules substance listed. filed no later than January 8, 2013. I or II are, and will continue to be, Dated: November 1, 2012. Dated: November 1, 2012. required to demonstrate to the Deputy Joseph T. Rannazzisi, Joseph T. Rannazzisi, Assistant Administrator, Office of Deputy Assistant Administrator, Office of Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Diversion Control, Drug Enforcement Diversion Control, Drug Enforcement Administration, that the requirements Administration. Administration. for such registration pursuant to 21 [FR Doc. 2012–27394 Filed 11–8–12; 8:45 am] [FR Doc. 2012–27440 Filed 11–8–12; 8:45 am] U.S.C. 958(a); 21 U.S.C. 823(a); and 21 BILLING CODE 4410–09–P CFR § 1301.34(b), (c), (d), (e), and (f) are BILLING CODE 4410–09–P satisfied. DEPARTMENT OF JUSTICE Dated: November 1, 2012. DEPARTMENT OF JUSTICE Joseph T. Rannazzisi, Drug Enforcement Administration Deputy Assistant Administrator, Office of Drug Enforcement Administration Diversion Control, Drug Enforcement Manufacturer of Controlled Administration. Manufacturer of Controlled Substances; Notice of Application; [FR Doc. 2012–27437 Filed 11–8–12; 8:45 am] Substances; Notice of Application; Johnson Matthey, Inc. BILLING CODE 4410–09–P Noramco, Inc. Pursuant to § 1301.33(a), Title 21 of Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), DEPARTMENT OF JUSTICE the Code of Federal Regulations (CFR), this is notice that on September 10, this is notice that on July 9, 2012, 2012, Johnson Matthey, Inc., Drug Enforcement Administration Noramco, Inc., 1440 Olympic Drive, Pharmaceuticals Materials, 900 River Importer Of Controlled Substances; Athens, Georgia 30601, made Road, Conshohocken, Pennsylvania Notice of Registration; Boehringer application by renewal to the Drug 19428, made application by renewal to Ingelheim Chemicals, Inc. Enforcement Administration (DEA) to the Drug Enforcement Administration be registered as a bulk manufacturer of (DEA) to be registered as a bulk By Notice dated July 17, 2012, and the following basic classes of controlled manufacturer of the following basic published in the Federal Register on substances: classes of controlled substances:

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Drug Schedule Drug Schedule Enforcement Administration (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid I Dihydromorphine (9145) ...... I the following basic classes of controlled (2010). Amphetamine (1100) ...... II substances: Amphetamine (1100) ...... II Methamphetamine (1105) ...... II Methylphenidate (1724) ...... II Amobarbital (2125) ...... II Drug Schedule Codeine (9050) ...... II Pentobarbital (2270) ...... II Oxycodone (9143) ...... II Secobarbital (2315) ...... II Marihuana (7360) ...... I 4-Anilino-N-phenethyl-4-piperidine II Tetrahydrocannabinols (7370) ..... I (ANPP) (8333). Drug Schedule Phenylacetone (8501) ...... II The company plans to cultivate Cocaine (9041) ...... II Diphenoxylate (9170) ...... II Codeine (9050) ...... II marihuana for the National Institute on Hydrocodone (9193) ...... II Dihydrocodeine (9120) ...... II Drug Abuse for research approved by Meperidine (9230) ...... II Oxycodone (9143) ...... II the Department of Health and Human Methadone (9250) ...... II Hydromorphone (9150) ...... II Services. Methadone intermediate (9254) ... II Diphenoxylate (9170) ...... II Any other such applicant, and any Morphine (9300) ...... II Ecgonine (9180) ...... II person who is presently registered with Thebaine (9333) ...... II Hydrocodone (9193) ...... II DEA to manufacture such substances, Meperidine (9230) ...... II may file comments or objections to the The company plans to manufacture Methadone (9250) ...... II issuance of the proposed registration the listed controlled substances in bulk Morphine (9300) ...... II Thebaine (9333) ...... II pursuant to 21 CFR 1301.33(a). for distribution and sale to its Oxymorphone (9652) ...... II Any such written comments or customers. Alfentanil (9737) ...... II objections should be addressed, in The Thebaine (9333) will also be used Remifentanil (9739) ...... II quintuplicate, to the Drug Enforcement to manufacture other controlled Sufentanil (9740) ...... II Administration, Office of Diversion substances for sale in bulk to its Fentanyl (9801) ...... II Control, Federal Register Representative customers. (ODL), 8701 Morrissette Drive, Any other such applicant, and any The company plans on manufacturing Springfield, Virginia 22152; and must be person who is presently registered with the listed controlled substances in bulk filed no later than January 8, 2013. for sale to its customers. DEA to manufacture such substances, Dated: November 1, 2012. Any other such applicant, and any may file comments or objections to the person who is presently registered with Joseph T. Rannazzisi, issuance of the proposed registration DEA to manufacture such substances, Deputy Assistant Administrator, Office of pursuant to 21 CFR 1301.33(a). may file comments or objections to the Diversion Control, Drug Enforcement Administration. Any such written comments or issuance of the proposed registration objections should be addressed, in pursuant to 21 CFR 1301.33(a). [FR Doc. 2012–27441 Filed 11–8–12; 8:45 am] quintuplicate, to the Drug Enforcement Any such written comments or BILLING CODE 4410–09–P Administration, Office of Diversion objections should be addressed, in Control, Federal Register Representative quintuplicate, to the Drug Enforcement DEPARTMENT OF JUSTICE (ODL), 8701 Morrissette Drive, Administration, Office of Diversion Springfield, Virginia 22152; and must be Control, Federal Register Representative Drug Enforcement Administration filed no later than January 8, 2013. (ODL), 8701 Morrissette Drive, Dated: November 1, 2012. Springfield, Virginia 22152; and must be Manufacturer of Controlled Joseph T. Rannazzisi, filed no later than January 8, 2013. Substances; Notice of Application; INB Deputy Assistant Administrator, Office of Dated: November 1, 2012. Hauser Pharmaceutical Services, Inc. Diversion Control, Drug Enforcement Joseph T. Rannazzisi, Administration. Pursuant to § 1301.33(a), Title 21 of Deputy Assistant Administrator, Office of the Code of Federal Regulations (CFR), [FR Doc. 2012–27398 Filed 11–8–12; 8:45 am] Diversion Control, Drug Enforcement this is notice that on September 20, BILLING CODE 4410–09–P Administration. 2012, InB Hauser Pharmaceutical [FR Doc. 2012–27401 Filed 11–8–12; 8:45 am] Services, Inc., 6880 N. Broadway, Suite BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE H, Denver, Colorado 80221, made application by letter to the Drug Drug Enforcement Administration Enforcement Administration (DEA) to DEPARTMENT OF JUSTICE be registered as a bulk manufacturer of Manufacturer of Controlled Drug Enforcement Administration 4-Anilino-N-phenethyl-4-piperidine Substances; Notice of Application, (8333), a basic class of controlled Cody Laboratories, Inc. Manufacturer of Controlled substance listed in schedule II. Substances Notice of Application; The company plans to manufacture Pursuant to § 1301.33(a), Title 21 of National Center For Natural Products the listed controlled substance in bulk the Code of Federal Regulations (CFR), Research (NIDA MPROJECT) for distribution and sale to its this is notice that on May 30, 2012, customers. Cody Laboratories, Inc., ATTN: Richard Pursuant to § 1301.33(a), Title 21 of Any other such applicant, and any Asherman, 601 Yellowstone Avenue, the Code of Federal Regulations (CFR), person who is presently registered with Cody, Wyoming 82414, made this is notice that on July 17, 2012, DEA to manufacture such substance, application by renewal to the Drug National Center for Natural Products may file comments or objections to the Enforcement Administration (DEA) to Research—NIDA MProject, University of issuance of the proposed registration be registered as a bulk manufacturer of Mississippi, 135 Coy Waller Complex, pursuant to 21 CFR 1301.33(a). the following basic classes of controlled University, Mississippi 38677, made Any such written comments or substances: application by renewal to the Drug objections should be addressed, in

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quintuplicate, to the Drug Enforcement of Staffmark and including on-site leased LLC, D/B/A ZeroChaos, who worked on- Administration, Office of Diversion workers of Staffmark whose wages are paid site at State Street Corporation, Putnam Control, Federal Register Representative under CBS Personnel, Inc., Statesville, North Cash Reconciliation Team, Quincy, (ODL), 8701 Morrissette Drive, Carolina, who became totally or partially Massachusetts (TA–W–81,998). separated from employment on or after Springfield, Virginia 22152; and must be March 1, 2011 through April 6, 2014, and all The amended notice applicable to filed no later than January 8, 2013. workers in the group threatened with total or TA–W–81,576 is hereby issued as Dated: November 1, 2012. partial separation from employment on April follows: Joseph T. Rannazzisi, 6, 2012 through April 6, 2014, are eligible to All workers of State Street Corporation, apply for adjustment assistance under Deputy Assistant Administrator, Office of Putnam Cash Reconciliations Team, Chapter 2 of Title II of the Trade Act of 1974, Diversion Control, Drug Enforcement including on-site leased workers from APC as amended. Administration. Workforce Solutions II, LLC, D/B/A ZeroChaos, Quincy, Massachusetts, who [FR Doc. 2012–27400 Filed 11–8–12; 8:45 am] Signed in Washington, DC, this 26th day of became totally or partially separated from BILLING CODE 4410–09–P October, 2012. employment on or after April 26, 2011 Del Min Amy Chen, through June 18, 2012, and all workers in the Certifying Officer, Office of Trade Adjustment group threatened with total or partial DEPARTMENT OF LABOR Assistance. separation from employment on June 18, [FR Doc. 2012–27413 Filed 11–8–12; 8:45 am] 2012 through June 18, 2014, are eligible to apply for adjustment assistance under Employment and Training BILLING CODE 4510–FN–P Administration Chapter 2 of Title II of the Trade Act of 1974, as amended. [TA–W–81,393] DEPARTMENT OF LABOR Signed in Washington, DC, this 24th day of Trim Systems Operating Corp., a October, 2012. Subsidiary of Commercial Vehicle Employment and Training Del Min Amy Chen, Group, Inc., Including On-Site Leased Administration Certifying Officer, Office of Trade Adjustment Assistance. Workers From Staffmark, Including On- [TA–W–81,576] Site Leased Workers From Staffmark [FR Doc. 2012–27414 Filed 11–8–12; 8:45 am] Whose Wages Are Paid Under CBS State Street Corporation, Putnam Cash BILLING CODE 4510–FN–P Personnel, Inc., Statesville, NC; Reconciliations Team, Including On- Amended Certification Regarding Site Leased Workers From APC Eligibility To Apply for Worker Workforce Solutions II, LLC, D/B/A DEPARTMENT OF LABOR Adjustment Assistance ZeroChaos, Quincy, MA; Amended Certification Regarding Eligibility To Employment and Training In accordance with Section 223 of the Apply for Worker Adjustment Administration Trade Act of 1974, as amended (‘‘Act’’), Assistance [TA–W–81,739; TA–W–81,739A] 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to In accordance with Section 223 of the Hewlett-Packard Company, Design Apply for Worker Adjustment Trade Act of 1974, as amended (‘‘Act’’), Delivery Organization (DDO), Including Assistance on April 6, 2012, applicable 19 U.S.C. § 2273, the Department of On-Site Leased Workers From to workers and former workers of Trim Labor (Department) issued a Manpower, Synova Inc., and Pinnacle Systems Operating Corp., a subsidiary of Certification of Eligibility To Apply for Technical Resources, Corvallis, OR; Commercial Vehicle Group, Inc., Worker Adjustment Assistance on June Hewlett-Packard Company, Ink Jet & Statesville, North Carolina. The 16, 2012, applicable to workers and Web Services, World Wide Design workers’ firm is engaged in activities former workers of State Street Group, Vancouver, WA; Amended related to production of interior Corporation, Putnam Cash Certification Regarding Eligibility To headliners, backwall and sidewall Reconciliation Team, Quincy, Apply for Worker Adjustment panels, flooring, curtains, and bunks for Massachusetts. The workers were Assistance commercial vehicles. The worker group engaged in activities related to the also includes on-site leased workers supply of cash reconciliation services. In accordance with Section 223 of the from Staffmark. New information obtained by the Trade Act of 1974, as amended (‘‘Act’’), At the request of a company official, Department revealed that workers 19 U.S.C. 2273, the Department of Labor the Department reviewed the leased from APC Workforce Solutions II, issued a Certification of Eligibility to certification for workers of the subject LLC, doing business as (D/B/A) Apply for Worker Adjustment firm. New information provided by ZeroChaos, were employed on-site at Assistance on September 18, 2012, company officials show that some State Street Corporation, Putnam Cash applicable to workers of Hewlett- workers of Staffmark had wages paid Reconciliation Team, Quincy, Packard Company, Design Delivery under the name CBS Personnel, Inc. Massachusetts. The Department has Organization (DDO), Corvallis, Oregon. The intent of the Department’s determined that these workers were The Department’s notice of certification is to include all workers of sufficiently under the control of the determination was published in the the subject firm, including on-site subject firm to be considered leased Federal Register on October 5, 2012 (77 leased worker, who were adversely workers. FR 194). Workers are engaged in affected by a shift in production to a Based on these findings, the activities related to the supply of new foreign country. Department is amending this product introduction, development, and The amended notice applicable to certification to include on-site workers support. TA–W–81,393 is hereby issued as leased from APC Workforce Solutions II, New information obtained by the follows: LLC, D/B/A ZeroChaos, and has subject firm revealed that workers at All workers of Trim Systems Operating terminated the investigation of the Hewlett-Packard Company, Ink Jet & Corp., a subsidiary of Commercial Vehicle petition that was filed on behalf of Web Services, World Wide Design Group, Inc., including on-site leased workers workers of APC Workforce Solutions II, Group, Vancouver, Washington

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operated in conjunction with Hewlett- Federal Register on October 12, 2012 In order for an affirmative Packard Company, DDO, Corvallis, (77 FR 62262). determination to be made for workers of Oregon. At the request of a state workforce a primary firm and a certification issued The intent of the Department’s office, the Department reviewed the regarding eligibility to apply for worker certification is to include all workers at certification for workers of the subject adjustment assistance, each of the group Hewlett-Packard Company, DDO, firm. The workers are engaged in eligibility requirements of Section Corvallis, Oregon and Hewlett-Packard activities related to the production of 222(a) of the Act must be met. Company, Ink Jet & Web Services, roof and floor decks. I. Under Section 222(a)(2)(A), the World Wide Design Group, Vancouver, New information shows that some following must be satisfied: Washington who were adversely workers separated from employment at (1) A significant number or proportion affected by a shift of services abroad. RG Steel Wheeling, LLC had their wages of the workers in such workers’ firm The amended notice applicable to reported through a separate have become totally or partially TA–W–81,739 is hereby issued as unemployment insurance (UI) tax separated, or are threatened to become account under the name Severstal follows: totally or partially separated; Wheeling, a former owner of the All workers of Hewlett-Packard Company, workers’ firm. (2) The sales or production, or both, Design Delivery Organization (DDO), The intent of the Department’s of such firm have decreased absolutely; including on-site leased workers from and Manpower, Synova, Inc., and Pinnacle certification is to include all workers of the subject firm who meet the worker (3) One of the following must be Technical Resources, Corvallis, Oregon (TA– satisfied: W–81,739), and all workers of Hewlett- group certification criteria under Packard Company, Ink Jet & Web Services, Section 222(b) of the Act, 19 U.S.C. (A) Imports of articles or services like World Wide Design Group, Vancouver, 2272(b). or directly competitive with articles Washington (TA–W- 81,739A), who became Accordingly, the Department is produced or services supplied by such totally or partially separated from amending this certification to properly firm have increased; employment on or after June 20, 2011 reflect this matter. (B) Imports of articles like or directly through September 18, 2012, and all workers The amended notice applicable to competitive with articles into which one in the groups threatened with total or partial TA–W–81,879 is hereby issued as or more component parts produced by separation from employment on date of follows: certification through two years from the date such firm are directly incorporated, of certification, are eligible to apply for All workers of RG Steel Wheeling, LLC, a have increased; adjustment assistance under Chapter 2 of division of RG Steel, LLC, doing business as (C) Imports of articles directly Title II of the Trade Act of 1074, as amended. Wheeling Corrugating Company, Beech incorporating one or more component Bottom, West Virginia, including workers Signed at Washington, DC this 31st day of parts produced outside the United whose unemployment insurance (UI) wages States that are like or directly October, 2012. are reported through Severstal Wheeling who Del Min Amy Chen, became totally or partially separated from competitive with imports of articles Certifying Officer, Office of Trade Adjustment who became totally or partially separated incorporating one or more component Assistance. from employment on or after August 7, 2011, parts produced by such firm have [FR Doc. 2012–27415 Filed 11–8–12; 8:45 am] through September 25, 2014, and all workers increased; in the group threatened with total or partial BILLING CODE 4510–FN–P (D) Imports of articles like or directly separation from employment on date of competitive with articles which are certification through two years from the date produced directly using services of certification, are eligible to apply for DEPARTMENT OF LABOR adjustment assistance under Chapter 2 of supplied by such firm, have increased; Title II of the Trade Act of 1974, as amended. and Employment and Training Signed in Washington, DC this 1st day of (4) The increase in imports Administration November, 2012. contributed importantly to such Elliott S. Kushner, workers’ separation or threat of [TA–W–81,879] separation and to the decline in the Certifying Officer, Office of Trade Adjustment sales or production of such firm; or RG Steel Wheeling, LLC, a Division of Assistance. II. Section 222(a)(2)(B) all of the RG Steel, LLC, Doing Business as [FR Doc. 2012–27416 Filed 11–8–12; 8:45 am] following must be satisfied: Wheeling Corrugating Company, BILLING CODE 4510–FN–P Including Workers Whose Wages Were (1) A significant number or proportion Reported Through Severstal Wheeling, of the workers in such workers’ firm Beech Bottom, WV; Amended DEPARTMENT OF LABOR have become totally or partially Certification Regarding Eligibility To separated, or are threatened to become Employment and Training Apply for Worker Adjustment totally or partially separated; Administration Assistance (2) One of the following must be satisfied: Notice of Determinations Regarding (A) There has been a shift by the In accordance with Section 223 of the Eligibility To Apply for Worker workers’ firm to a foreign country in the Trade Act of 1974, as amended (‘‘Act’’), Adjustment Assistance 19 U.S.C. 2273, the Department of Labor production of articles or supply of issued a Certification of Eligibility to In accordance with Section 223 of the services like or directly competitive Apply for Worker Adjustment Trade Act of 1974, as amended (19 with those produced/supplied by the Assistance on September 25, 2012, U.S.C. 2273) the Department of Labor workers’ firm; applicable to workers of RG Steel herein presents summaries of (B) There has been an acquisition Wheeling, LLC, a division of RG Steel, determinations regarding eligibility to from a foreign country by the workers’ LLC, doing business as Wheeling apply for trade adjustment assistance for firm of articles/services that are like or Corrugating Company, Beech Bottom, workers by (TA–W) number issued directly competitive with those West Virginia. The Department’s notice during the period of October 15, 2012 produced/supplied by the workers’ firm; of determination was published in the through October 19, 2012. and

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(3) The shift/acquisition contributed received a certification of eligibility the Tariff Act of 1930 (19 U.S.C. importantly to the workers’ separation under Section 222(a) of the Act, and 1671d(b)(1)(A) and 1673d(b)(1)(A)); or threat of separation. such supply or production is related to (2) The petition is filed during the 1- In order for an affirmative the article or service that was the basis year period beginning on the date on determination to be made for adversely for such certification; and which— affected workers in public agencies and (3) Either— (A) A summary of the report a certification issued regarding (A) The workers’ firm is a supplier submitted to the President by the eligibility to apply for worker and the component parts it supplied to International Trade Commission under adjustment assistance, each of the group the firm described in paragraph (2) section 202(f)(1) with respect to the eligibility requirements of Section accounted for at least 20 percent of the affirmative determination described in 222(b) of the Act must be met. production or sales of the workers’ firm; paragraph (1)(A) is published in the (1) A significant number or proportion or of the workers in the public agency have (B) A loss of business by the workers’ Federal Register under section 202(f)(3); become totally or partially separated, or firm with the firm described in or are threatened to become totally or paragraph (2) contributed importantly to (B) Notice of an affirmative partially separated; the workers’ separation or threat of determination described in (2) The public agency has acquired separation. subparagraph (1) is published in the from a foreign country services like or In order for an affirmative Federal Register; and directly competitive with services determination to be made for adversely (3) The workers have become totally which are supplied by such agency; and affected workers in firms identified by or partially separated from the workers’ (3) The acquisition of services the International Trade Commission and firm within— contributed importantly to such a certification issued regarding (A) The 1-year period described in workers’ separation or threat of eligibility to apply for worker paragraph (2); or separation. adjustment assistance, each of the group (B) Notwithstanding section 223(b)(1), In order for an affirmative eligibility requirements of Section 222(f) determination to be made for adversely the 1-year period preceding the 1-year of the Act must be met. period described in paragraph (2). affected secondary workers of a firm and (1) The workers’ firm is publicly a certification issued regarding identified by name by the International Affirmative Determinations for Worker eligibility to apply for worker Trade Commission as a member of a Adjustment Assistance adjustment assistance, each of the group domestic industry in an investigation eligibility requirements of Section resulting in— The following certifications have been 222(c) of the Act must be met. (A) An affirmative determination of issued. The date following the company (1) A significant number or proportion serious injury or threat thereof under name and location of each of the workers in the workers’ firm have section 202(b)(1); determination references the impact become totally or partially separated, or (B) An affirmative determination of date for all workers of such are threatened to become totally or market disruption or threat thereof determination. partially separated; under section 421(b)(1); or The following certifications have been (2) The workers’ firm is a Supplier or (C) An affirmative final determination issued. The requirements of Section Downstream Producer to a firm that of material injury or threat thereof under 222(a)(2)(A) (increased imports) of the employed a group of workers who section 705(b)(1)(A) or 735(b)(1)(A) of Trade Act have been met.

TA–W No. Subject firm Location Impact date

81,717 ...... Sanmina-SCI, MSD Division, Manpower ...... Turtle Lake, WI ...... June 7, 2011.

The following certifications have been services) of the Trade Act have been issued. The requirements of Section met. 222(a)(2)(B) (shift in production or

TA–W No. Subject firm Location Impact date

81,918 ...... Avnet, Inc., Logistics Div., Collectron and Sonitronies, Remote Richardson, TX ...... August 23, 2011. Workers in Nogales, AZ. 81,921 ...... Schneider Electric, Global Supply Chain, NA, leased workers from Cedar Rapids, IA ...... August 24, 2011. Volt Workforce Solutions. 81,961 ...... American Express Travel Related Services Company, Inc., World Salt Lake City, UT ...... September 6, 2011. Service Global New Accounts, Kelly Services. 81,966 ...... AT&T Services, Inc., Information Technology Operations, Global Bothell, WA ...... August 5, 2012. Systems Hosting, etc. 81,966A ...... Leased Workers from Collabera, Inc., Data Domain LLC, Data Bothell, WA ...... September 12, 2011. Vista, Inc., Decision One, EMC Corporation, Etech, Evergreen Power Systems, etc. 81,973 ...... Sun Life Financial (U.S.) Services Company, Inc., Sun Life Finan- Greenfield, MA ...... September 17, 2011. cial, Inc., Adecco. 81,987 ...... Cincinnati Bell Telephone Company, LLC, Cincinnati Bell, Inc., Call Norwood, OH ...... September 19, 2011. Center Operations Division. 81,987A ...... Cincinnati Bell Telephone Company, LLC, Cincinnati Bell, Inc., Call Lebanon, OH ...... September 19, 2011. Center Operations Division. 81,992 ...... Cox Media Group Ohio, Inc., Graphic Design Group, Cox Enter- Dayton, OH ...... September 20, 2011. prises, Inc.

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TA–W No. Subject firm Location Impact date

81,994 ...... Ahlstrom West Carrollton LLC ...... West Carrollton, OH ...... September 20, 2011. 82,002 ...... E! Entertainment Television, LLC, G4 Media, NBC Universal, Cable Los Angeles, CA ...... September 24, 2011. Networks, Randstad Sourceright, etc.. 82,006 ...... Tellabs Inc., Supply Chain Test Engineering Division ...... Naperville, IL ...... September 25, 2011. 82,007 ...... Maysteel LLC, a subsidiary of Everett Smith Group LTD, leased Creedmoor, NC ...... September 25, 2011. from Randstad Engineering, Aerotek Commercial Staffing. 82,007A ...... Maysteel LLC, a subsidiary of Everett LTD ...... Allenton, WI ...... September 25, 2011. 82,008 ...... BRP US, Inc., Sport Boat Division, Select Remedy ...... Benton, IL ...... September 25, 2011. 82,009 ...... ITT Cannon, LLC, a subsidiary of ITT Corporation, on-site leased Santa Ana, CA ...... September 25, 2011. Innovative, First Choice, Prosearch, First, Peopleware, etc. 82,012 ...... Oxford Collections, Customer Service Department, LF USA ...... Gaffney, SC ...... March 13, 2012. 82,039 ...... Wellpoint, Inc., Wellpoint Companies, West Host Claims & Adjust- Denver, CO ...... October 2, 2011. ment, Kelly Services, Aerotek. 82,046 ...... Wire Company Holdings, Inc. DBA New York Wire, Wire Mesh Hanover, PA ...... October 2, 2011. Holdings, Inc., Manpower. 82,046A ...... Wire Company Holdings, Inc. DBA New York Wire, E. Market York, PA ...... October 2, 2011. Street Facility, Wire Mesh Holdings, Manpower and Temp Star. 82,046B ...... Wire Company Holdings, Inc. DBA New York Wire, Loucks Mill York, PA ...... October 2, 2011. Road, Wire Mesh Holdings, Temp Star Staffing. 82,048 ...... Hartford Financial Services Group, Inc., Operations/Wealth Man- Windsor, CT ...... October 3, 2011. agement/Document Control Services. 82,049 ...... Hartford Financial Services Group, Inc., Corporate/Finance/Control- Simsbury, CT ...... October 3, 2011. lers/Accounting Operations. 82,049A ...... Hartford Financial Services Group, Inc., Corporate/Finance/Control- Hartford, CT ...... October 3, 2011. lers/Accounting Operations. 82,050 ...... Hartford Financial Services Group, Inc., IT/Project Management ..... Simsbury, CT ...... October 3, 2011. 82,050A ...... Hartford Financial Services Group, Inc., IT/Project Management ..... Hartford, CT ...... October 3, 2011. 82,050B ...... Hartford Financial Services Group, Inc., IT/Project Management ..... Windsor, CT ...... October 3, 2011. 82,051 ...... Hartford Financial Services Group, Inc., Operations/Commercial/ San Antonio, TX ...... October 3, 2011. Premium Audit/Reviewers. 82,051A ...... Hartford Financial Services Group, Inc., Operations/Commercial/ Clinton, NY ...... October 3, 2011. Premium Audit/Reviewers. 82,055 ...... Hartford Financial Services Group, Inc., Operations/Commercial Windsor, CT ...... October 4, 2011. Markets/Group Benefits/STAT BRC. 82,056 ...... Hartford Financial Services Group, Inc., Operations/Commercial Overland Park, KS ...... October 4, 2011. Markets/Group Benefits/STAT BRC.

The following certifications have been are certified eligible to apply for TAA) issued. The requirements of Section of the Trade Act have been met. 222(c) (supplier to a firm whose workers

TA–W No. Subject firm Location Impact date

81,859 ...... PBS Coals, Inc., David Stanley Consultants and Strata Mine Serv- Friedens, PA ...... August 6, 2011. ices, UI Wages through Roxcoal.

Negative Determinations for Worker criteria for worker adjustment assistance (decline in sales or production, or both) Adjustment Assistance have not been met for the reasons and (a)(2)(B) (shift in production or specified. services to a foreign country) of section In the following cases, the The investigation revealed that the 222 have not been met. investigation revealed that the eligibility criteria under paragraphs (a)(2)(A)(i)

TA–W No. Subject firm Location Impact date

81,929 ...... Joy Global, Inc., Joy Technologies, All Seasons Temporaries and Franklin, PA. Manpower.

The investigation revealed that the (increased imports) and (a)(2)(B) (shift country) of section 222 have not been criteria under paragraphs(a)(2)(A) in production or services to a foreign met.

TA–W No. Subject firm Location Impact date

81,744 ...... Kyowa America Corporation, Pennsylvania Division, Kyowa Electric Waynesburg, PA. & Chemical Japan, Spherion Staffing. 81,804 ...... Earthgrains Baking Companies, Inc., Earthgrains Baking Group, Knoxville, TN. dba Bimbo Bakeries, USA, Randstand. 81,964 ...... Hewlett Packard Company, Switchboard Division ...... Plano, TX.

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TA–W No. Subject firm Location Impact date

82,022 ...... RG Steel ...... Allenport, PA.

Determinations Terminating on the Department’s Web site, as The following determinations Investigations of Petitions for Worker required by Section 221 of the Act (19 terminating investigations were issued Adjustment Assistance U.S.C. 2271), the Department initiated because the petitioner has requested After notice of the petitions was investigations of these petitions. that the petition be withdrawn. published in the Federal Register and

TA–W number Subject firm Location Impact date

81,934 ...... Zenda Leather ...... Connelly Springs, NC. 82,042 ...... Covidien ...... Seneca, SC.

The following determinations workers are covered by active no purpose since the petitioning group terminating investigations were issued certifications. Consequently, further of workers cannot be covered by more because the petitioning groups of investigation in these cases would serve than one certification at a time.

TA–W No. Subject firm Location Impact date

81,998 ...... APC Workforce Solutions II, LLC, dba Zerochaos, State Street Cor- Quincy, MA. poration. 82,054 ...... Hartford Financial Services Group, Inc., IT/Project Management ..... Windsor, CT.

The following determinations because the petitions are the subject of filed earlier covering the same terminating investigations were issued ongoing investigations under petitions petitioners.

TA–W No. Subject firm Location Impact date

82,017 ...... PotashCorp-Aurora ...... Aurora, NC.

I hereby certify that the apply for trade adjustment assistance for (C) Imports of articles directly aforementioned determinations were workers by (TA–W) number issued incorporating one or more component issued during the period of October 15, during the period of October 22, 2012 parts produced outside the United 2012 through October 19, 2012. These through October 26, 2012. States that are like or directly determinations are available on the In order for an affirmative competitive with imports of articles Department’s Web site tradeact/taa/taa determination to be made for workers of incorporating one or more component search firm.cfm under the searchable a primary firm and a certification issued parts produced by such firm have listing of determinations or by calling regarding eligibility to apply for worker increased; the Office of Trade Adjustment adjustment assistance, each of the group (D) Imports of articles like or directly Assistance toll free at 888–365–6822. eligibility requirements of Section competitive with articles which are Dated: October 31, 2012. 222(a) of the Act must be met. produced directly using services Elliott S. Kushner, I. Under Section 222(a)(2)(A), the supplied by such firm, have increased; following must be satisfied: and Certifying Officer, Office of Trade Adjustment (1) A significant number or proportion Assistance. (4) The increase in imports of the workers in such workers’ firm contributed importantly to such [FR Doc. 2012–27418 Filed 11–8–12; 8:45 am] have become totally or partially BILLING CODE 4510–FN–P workers’ separation or threat of separated, or are threatened to become separation and to the decline in the totally or partially separated; sales or production of such firm; or (2) The sales or production, or both, DEPARTMENT OF LABOR II. Section 222(a)(2)(B) all of the of such firm have decreased absolutely; following must be satisfied: and Employment and Training (1) A significant number or proportion Administration (3) One of the following must be satisfied: of the workers in such workers’ firm Notice of Determinations Regarding (A) Imports of articles or services like have become totally or partially Eligibility To Apply for Worker or directly competitive with articles separated, or are threatened to become Adjustment Assistance produced or services supplied by such totally or partially separated; firm have increased; (2) One of the following must be In accordance with Section 223 of the (B) Imports of articles like or directly satisfied: Trade Act of 1974, as amended (19 competitive with articles into which one (A) There has been a shift by the U.S.C. 2273) the Department of Labor or more component parts produced by workers’ firm to a foreign country in the herein presents summaries of such firm are directly incorporated, production of articles or supply of determinations regarding eligibility to have increased; services like or directly competitive

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with those produced/supplied by the are threatened to become totally or (C) An affirmative final determination workers’ firm; partially separated; of material injury or threat thereof under (B) There has been an acquisition (2) The workers’ firm is a Supplier or section 705(b)(1)(A) or 735(b)(1)(A) of from a foreign country by the workers’ Downstream Producer to a firm that the Tariff Act of 1930 (19 U.S.C. firm of articles/services that are like or employed a group of workers who 1671d(b)(1)(A) and 1673d(b)(1)(A)); directly competitive with those received a certification of eligibility (2) The petition is filed during the 1- produced/supplied by the workers’ firm; under Section 222(a) of the Act, and year period beginning on the date on and such supply or production is related to which— (3) The shift/acquisition contributed the article or service that was the basis (A) A summary of the report importantly to the workers’ separation for such certification; and submitted to the President by the or threat of separation. (3) Either— In order for an affirmative International Trade Commission under (A) The workers’ firm is a supplier section 202(f)(1) with respect to the determination to be made for adversely and the component parts it supplied to affected workers in public agencies and affirmative determination described in the firm described in paragraph (2) paragraph (1)(A) is published in the a certification issued regarding accounted for at least 20 percent of the eligibility to apply for worker Federal Register under section 202(f)(3); production or sales of the workers’ firm; or adjustment assistance, each of the group or eligibility requirements of Section (B) Notice of an affirmative (B) A loss of business by the workers’ determination described in 222(b) of the Act must be met. firm with the firm described in (1) A significant number or proportion subparagraph (1) is published in the paragraph (2) contributed importantly to of the workers in the public agency have Federal Register; and the workers’ separation or threat of become totally or partially separated, or (3) The workers have become totally separation. are threatened to become totally or or partially separated from the workers’ In order for an affirmative partially separated; firm within— (2) The public agency has acquired determination to be made for adversely affected workers in firms identified by (A) The 1-year period described in from a foreign country services like or paragraph (2); or directly competitive with services the International Trade Commission and (B) Notwithstanding section 223(b)(1), which are supplied by such agency; and a certification issued regarding (3) The acquisition of services eligibility to apply for worker the 1-year period preceding the 1-year contributed importantly to such adjustment assistance, each of the group period described in paragraph (2). workers’ separation or threat of eligibility requirements of Section 222(f) Affirmative Determinations for Worker separation. of the Act must be met. Adjustment Assistance In order for an affirmative (1) The workers’ firm is publicly determination to be made for adversely identified by name by the International The following certifications have been affected secondary workers of a firm and Trade Commission as a member of a issued. The date following the company a certification issued regarding domestic industry in an investigation name and location of each eligibility to apply for worker resulting in— determination references the impact adjustment assistance, each of the group (A) An affirmative determination of date for all workers of such eligibility requirements of Section serious injury or threat thereof under determination. 222(c) of the Act must be met. section 202(b)(1); The following certifications have been (1) A significant number or proportion (B) An affirmative determination of issued. The requirements of Section of the workers in the workers’ firm have market disruption or threat thereof 222(a)(2)(A) (increased imports) of the become totally or partially separated, or under section 421(b)(1); or Trade Act have been met.

TA–W No. Subject firm Location Impact date

81,747 ...... Logan Industries ...... Spokane, WA ...... January 26, 2012. 81,747A ...... Aerotek Commercial, Inc., Working On-Site at Logan Industries ... Spokane, WA ...... June 14, 2011. 81,861 ...... Marlatex Corporation ...... Belmont, NC ...... August 3, 2011. 82,052 ...... Envelope Product Group, LLC, Cenveo Corporation ...... Kenosha, WI ...... October 2, 2011.

The following certifications have been services) of the Trade Act have been issued. The requirements of Section met. 222(a)(2)(B) (shift in production or

TA–W No. Subject firm Location Impact date

81,857 ...... Cordia IP Corporation, Cordia Communications Corporation ...... Winter Garden, FL ...... August 4, 2011. 81,904 ...... American Showa, Inc., Blanchester Plant, Adecco ...... Blanchester, OH ...... August 16, 2011. 81,945 ...... Pfizer Therapeutic Research, Pfizer Worldwide R&D, Warner Groton, CT ...... September 5, 2011. Lambert, Charles River, etc. 81,949 ...... SDL Enterprise Technologies, Inc., Help Desk ...... Chicago, IL ...... September 6, 2011. 81,951 ...... AGI—Shorewood ...... Weaverville, NC ...... September 6, 2011. 81,960 ...... Verizon Business Networks Services, Inc., Verizon Services Or- Highlands, CO ...... September 7, 2011. ganization, Senior Coordinator—Customer Service. 81,962 ...... Verizon Business Networks Services, Inc., Lead Specialist— Richardson, TX ...... September 10, 2011. Technical Service and Manager—Technical Service. 81,962A ...... Verizon Business Networks Services, Inc., Lead Specialist— Rancho Cordova, CA ...... September 10, 2011. Technical Service and Manager—Technical Service.

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TA–W No. Subject firm Location Impact date

81,962B ...... Verizon Business Networks Services, Inc., Lead Specialist— Patchogue, NY ...... September 10, 2011. Technical Service and Manager—Technical Service. 81,962C ...... Verizon Business Networks Services, Inc., Lead Specialist— Rye Brook, NY ...... September 10, 2011. Technical Service and Manager—Technical Service. 81,962D ...... Verizon Business Networks Services, Inc., Lead Specialist— San Antonio, TX ...... September 10, 2011. Technical Service and Manager—Technical Service. 81,962E ...... Verizon Business Networks Services, Inc., Lead Specialist— Ashburn, VA ...... September 10, 2011. Technical Service and Manager—Technical Service. 81,969 ...... Schawk Minneapolis ...... Minneapolis, MN ...... October 17, 2011. 81,986 ...... Genzyme Corporation, Sanofi S.A., Enterprise IT Network Oper- Framingham, MA ...... September 20, 2011. ations Center, Pro-Unlimited. 81,991 ...... Delphi Electronics and Safety, Delphi Corporation ...... Kokomo, IN ...... March 25, 2012. 81,991A ...... Leased Workers from ACRO Service Corporation, Advantage, Kokomo, IN ...... September 20, 2011. Technical Resources, Aerotek, Delphi Electronics, Delphi Corp. 81,991B ...... Delphi Electronics and Safety, Delphi Corporation, Alliance Group Auburn Hills, MI ...... September 20, 2011. Technologies, Bartech Group, etc. 81,993 ...... Experian Marketing Solutions, Data Marketing Service Division, Schaumburg, IL ...... September 20, 2011. Tapfin Manpower Group Solutions. 81,995 ...... Bank of America, Internal Recon Control (IRC), Corp. Infrastruc- Seattle, WA ...... September 19, 2011. ture Finance Division. 82,001 ...... Royal Appliance Manufacturing Company, dba TTI Flooring Care Canton, OH ...... September 25, 2011. N.A., Hoover, Inc. 82,001A ...... Royal Appliance Manufacturing Company, dba TTI Flooring Care North Canton, OH ...... September 25, 2011. N.A., Hoover, Inc. 82,010 ...... Dell Marketing L.P., Public Sales in Major Public Accounts, Select Round Rock, TX ...... September 26, 2011. Public Accounts, etc. 82,020 ...... Asheboro Wire Plant-Hyosung USA, On-site Leased Workers Asheboro, NC ...... September 28, 2011. from Defender Staffing, Starr Electric Company, etc. 82,063 ...... Fashion Tech, Inc., A Division of Hunter Douglas ...... Portland, OR ...... October 8, 2011. 82,070 ...... The Great Atlantic & Pacific Tea Company, Inc., Accounting Montvale, NJ ...... October 10, 2011. Clerks. 82,072 ...... The Denver Post, Circulation Call Center, Ultimate Staffing Serv- Denver, CO ...... October 11, 2011. ice. 82,073 ...... Sartorius Stedim SUS, Inc., Sartorius Group North America, Concord, CA ...... October 12, 2011. Aerotek.

The following certifications have been are certified eligible to apply for TAA) issued. The requirements of Section of the Trade Act have been met. 222(c) (supplier to a firm whose workers

TA–W No. Subject firm Location Impact date

81,974 ...... Maryland Pig Services L.P ...... Sparrows Point, MD ...... September 17, 2011.

The following certifications have been 222(c) (downstream producer for a firm apply for TAA) of the Trade Act have issued. The requirements of Section whose workers are certified eligible to been met.

TA–W No. Subject firm Location Impact date

81,955 ...... Pocahontas Machine Works, Inc., A.I.D. Temporary Services, Inc Pocahontas, AR ...... September 6, 2011.

Negative Determinations for Worker criteria for worker adjustment assistance (b)(1), or (c)(1)(employment decline or Adjustment Assistance have not been met for the reasons threat of separation) of section 222 has specified. not been met. In the following cases, the The investigation revealed that the investigation revealed that the eligibility criterion under paragraph (a)(1), or

TA–W No. Subject firm Location Impact date

81,977 ...... Flavor House Products, Inc., Ralcorp Holdings, Inc., Ralcorp Dothan, AL. Snacks, Sauces and Spreads Division.

The investigation revealed that the (increased imports) and (a)(2)(B) (shift country) of section 222 have not been criteria under paragraphs(a)(2)(A) in production or services to a foreign met.

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TA–W No. Subject firm Location Impact date

81,926 ...... Hewlett Packard, Enterprise Services Division, Applications Best Pontiac, MI. Shore (CAGD). 81,926A ...... Hewlett Packard, Enterprise Services Division, Applications Best Cincinnati, OH. Shore (CAGD).

Determinations Terminating on the Department’s Web site, as The following determinations Investigations of Petitions for Worker required by Section 221 of the Act (19 terminating investigations were issued Adjustment Assistance U.S.C. 2271), the Department initiated because the petitioner has requested After notice of the petitions was investigations of these petitions. that the petition be withdrawn. published in the Federal Register and

TA–W No. Subject firm Location Impact date

81,980 ...... Bank of America ...... Addison, TX.

The following determinations by at least three individuals of the therefore, may not be part of a terminating investigations were issued petitioning worker group. Petitioners petitioning worker group. For one or in cases where these petitions were not separated more than one year prior to more of these reasons, these petitions filed in accordance with the the date of the petition cannot be were deemed invalid. requirements of 29 CFR 90.11. Every covered under a certification of a petition filed by workers must be signed petition under Section 223(b), and

TA–W No. Subject firm Location Impact date

81,978 ...... Peabody Energy ...... Evansville, IN.

The following determinations workers are covered by active no purpose since the petitioning group terminating investigations were issued certifications. Consequently, further of workers cannot be covered by more because the petitioning groups of investigation in these cases would serve than one certification at a time.

TA–W No. Subject firm Location Impact date

81,997 ...... Tyco Electronics, Telecom Networks (Business Unit) Division ...... Shakopee, MN. 82,019 ...... Delphi Electronics and Safety, Delphi Corporation ...... Auburn Hills, MI.

I hereby certify that the aforementioned of the Trade Act of 1974 (‘‘the Act’’) and Interested persons are invited to determinations were issued during the period are identified in the Appendix to this submit written comments regarding the of October 22, 2012 through October 26, notice. Upon receipt of these petitions, subject matter of the investigations to 2012. These determinations are available on the Department’s Web site tradeact/taa/taa the Director of the Office of Trade the Director, Office of Trade Adjustment search firm.cfm under the searchable listing Adjustment Assistance, Employment Assistance, at the address shown below, of determinations or by calling the Office of and Training Administration, has not later than November 19, 2012. instituted investigations pursuant to Trade Adjustment Assistance toll free at 888– The petitions filed in this case are 365–6822. Section 221 (a) of the Act. available for inspection at the Office of Dated: November 1, 2012. The purpose of each of the the Director, Office of Trade Adjustment investigations is to determine whether Elliott S. Kushner, Assistance, Employment and Training the workers are eligible to apply for Certifying Officer, Office of Trade Adjustment Administration, U.S. Department of adjustment assistance under Title II, Assistance. Labor, Room N–5428, 200 Constitution Chapter 2, of the Act. The investigations [FR Doc. 2012–27419 Filed 11–8–12; 8:45 am] Avenue, NW., Washington, DC 20210. BILLING CODE 4510–FN–P will further relate, as appropriate, to the determination of the date on which total Signed at Washington, DC this 24th day of or partial separations began or October 2012. DEPARTMENT OF LABOR threatened to begin and the subdivision Elliott S. Kushner, of the firm involved. Certifying Officer, Office of Trade Adjustment Employment and Training The petitioners or any other persons Assistance. Administration showing a substantial interest in the Investigations Regarding Eligibility To subject matter of the investigations may Apply for Worker Adjustment request a public hearing, provided such Assistance request is filed in writing with the Director, Office of Trade Adjustment Petitions have been filed with the Assistance, at the address shown below, Secretary of Labor under Section 221 (a) not later than November 19, 2012.

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APPENDIX [22 TAA petitions instituted between 10/15/12 and 10/19/12]

Date of Date of TA–W Subject firm (petitioners) Location institution petition

82074 ...... Komax Solar, Inc. (Workers) ...... York, PA ...... 10/15/12 10/12/12 82075 ...... Ingersoll Rand/Trane (Union) ...... Tyler, TX ...... 10/15/12 10/12/12 82076 ...... Manitowoc Foodservice, Lincoln Foodservice Division Fort Wayne, IN ...... 10/15/12 10/12/12 (Union). 82077 ...... Consolidated Pine Inc. (Workers) ...... Prineville, OR ...... 10/15/12 10/12/12 82078 ...... ASF Keystone, Inc. (Union) ...... Granite City, IL ...... 10/15/12 10/12/12 82079 ...... WellPoint Inc. (Anthem Blue Cross Blue Shield) (Workers) Richmond & Roanoke, VA .... 10/15/12 10/12/12 82080 ...... International Business Machines Corporation (IBM) (State/ Richmond, VA ...... 10/15/12 10/11/12 One-Stop). 82081 ...... Teters Floral Products (Workers) ...... Bolivar, MO ...... 10/15/12 10/12/12 82082 ...... The Evercare Company dba OneCare (State/One-Stop) .... Waynesboro, GA ...... 10/16/12 10/15/12 82083 ...... Net Cracker (State/One-Stop) ...... Cincinnati, OH ...... 10/16/12 10/15/12 82084 ...... Greene Brothers Furniture (Workers) ...... North Wilkesboro, NC ...... 10/17/12 09/20/12 82085 ...... Spherion Staffing (State/One-Stop) ...... Ft. Collins, CO ...... 10/17/12 10/16/12 82086 ...... Ball Metal Container Corporation (Union) ...... Columbus, OH ...... 10/17/12 10/16/12 82087 ...... Medtronic Advanced Energy (Formerly Known as PEAK Palo Alto, CA ...... 10/17/12 10/16/12 Surgical., Inc) (Company). 82088 ...... Deloitte Tax LLP (State/One-Stop) ...... Los Angeles, CA ...... 10/17/12 10/16/12 82089 ...... The Billings Gazette (Workers) ...... Billings, MT ...... 10/17/12 10/15/12 82090 ...... Oce Reprographic Technologies (State/One-Stop) ...... Phoenix, AZ ...... 10/17/12 10/16/12 82091 ...... T-Shirt International Inc. (Company) ...... Culloden, WV ...... 10/18/12 10/16/12 82092 ...... General Mills (State/One-Stop) ...... Minneapolis, MN ...... 10/18/12 10/18/12 82093 ...... Korean Air (Workers) ...... Los Angeles, CA ...... 10/18/12 10/17/12 82094 ...... Anthem Insurance Companies/Wellpoint, Inc. (State/One- Cape Girardeau, MO ...... 10/18/12 10/17/12 Stop). 82095 ...... Verizon Services Corporation (Workers) ...... Clarksburg, WV ...... 10/18/12 08/07/12

[FR Doc. 2012–27417 Filed 11–8–12; 8:45 am] Science Foundation, 4201 Wilson balance measurement sites located on BILLING CODE 4510–FN–P Boulevard, Arlington, Virginia 22230. the lower Taylor Glacier. Activities FOR FURTHER INFORMATION CONTACT: include collecting samples of water and Polly A. Penhale at the above address or ice, measuring stream discharge, and (703) 292–7420. traveling through the area on foot to NATIONAL SCIENCE FOUNDATION SUPPLEMENTARY INFORMATION: The access monitoring sites on the glacier National Science Foundation, as surface. Notice of Permit Applications Received directed by the Antarctic Conservation Under the Antarctic Conservation Act Location Act of 1978 (Pub. L. 95–541), as of 1978 amended by the Antarctic Science, ASPA 172- Blood Falls, Santa Fe Stream and the lower Taylor Glacier, AGENCY: National Science Foundation. Tourism and Conservation Act of 1996, Taylor Valley, McMurdo Dry Valleys. ACTION: Notice of Permit Applications has developed regulations for the Received under the Antarctic establishment of a permit system for Dates various activities in Antarctica and Conservation Act of 1978, Public Law December 1, 2012 to February 28, designation of certain animals and 95–541. 2017. certain geographic areas a requiring SUMMARY: The National Science special protection. The regulations Nadene G. Kennedy, Foundation (NSF) is required to publish establish such a permit system to Permit Officer, Office of Polar Programs. a notice of permit applications received designate Antarctic Specially Protected [FR Doc. 2012–27383 Filed 11–8–12; 8:45 am] to conduct activities regulated under the Areas. BILLING CODE 7555–01–P Antarctic Conservation Act of 1978. The applications received are as NSF has published regulations under follows: the Antarctic Conservation Act at Title 1. Applicant NATIONAL SCIENCE FOUNDATION 45 Part 670 of the Code of Federal Regulations. This is the required notice Permit Application: 2013–024. Notice of Permits Issued Under the of permit applications received. Diane M. McKnight, INSTARR, 1560 Antarctic Conservation Act of 1978 30th Street, Boulder, CO 80309. DATES: Interested parties are invited to AGENCY: National Science Foundation. submit written data, comments, or Activity for Which Permit Is Requested ACTION: Notice of permits issued under views with respect to this permit Enter Antarctic Specially Protected the Antarctic Conservation of 1978, application by December 10, 2012. This Areas. The applicant plans to enter Public Law 95–541. application may be inspected by access the recently designated Antarctic interested parties at the Permit Office, Specially Protected Area (ASPA) 172- SUMMARY: The National Science address below. Blood Falls, Santa Fe Stream and the Foundation (NSF) is required to publish ADDRESSES: Comments should be lower Taylor Glacier in order to conduct notice of permits issued under the addressed to Permit Office, Room 755, ongoing research at Blood Falls and Antarctic Conservation Act of 1978. Office of Polar Programs, National nearby streams and the glacier mass This is the required notice.

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FOR FURTHER INFORMATION CONTACT: will open at 8:30 a.m. Visitors will be added, deleted or postponed, please Nadene G. Kennedy, Permit Office, subject to security checks. contact: The Office of the Secretary at Office of Polar Programs, Rm. 755, This Sunshine Act notice is being (202) 551–5400. National Science Foundation, 4201 issued because a majority of the Dated: November 7, 2012. Wilson Boulevard, Arlington, VA 22230. Commission may attend the meeting. Elizabeth M. Murphy, SUPPLEMENTARY INFORMATION: On The forum will include remarks by October 3, 2012, the National Science SEC Commissioners and panel Secretary. Foundation published a notice in the discussions that Commissioners may [FR Doc. 2012–27529 Filed 11–7–12; 4:15 pm] attend. Panel topics will include JOBS Federal Register of a permit application BILLING CODE 8011–01–P received. A permit was issued on Act implementation and small business November 5, 2012 to: capital formation issues not addressed by the JOBS Act. Members of the public Diana Wall Permit No. 2013–023 SECURITIES AND EXCHANGE may attend the forum without charge. COMMISSION Nadene G. Kennedy, The Commissioner remarks and panel Permit Officer. discussions will be webcast from the Sunshine Act Meeting [FR Doc. 2012–27359 Filed 11–8–12; 8:45 am] SEC’s Web site. For further information, please BILLING CODE 7555–01–P Notice is hereby given, pursuant to contact the Office of the Secretary at the provisions of the Government in the (202) 551–5400. Sunshine Act, Public Law 94–409, that NATIONAL SCIENCE FOUNDATION Dated: November 7, 2012. the Securities and Exchange Elizabeth M. Murphy, Commission will hold a Closed Meeting Notice of Permits Issued Under the Secretary. on Thursday, November 15, 2012 at Antarctic Conservation Act of 1978 [FR Doc. 2012–27528 Filed 11–7–12; 4:15 pm] 10:00 a.m. AGENCY: National Science Foundation. BILLING CODE 8011–01–P Commissioners, Counsel to the ACTION: Notice of permits issued under Commissioners, the Secretary to the Commission, and recording secretaries the Antarctic Conservation of 1978, SECURITIES AND EXCHANGE will attend the Closed Meeting. Certain Public Law 95–541. COMMISSION staff members who have an interest in SUMMARY: The National Science Sunshine Act Meeting the matters also may be present. Foundation (NSF) is required to publish notice of permits issued under the Notice is hereby given, pursuant to The General Counsel of the Antarctic Conservation Act of 1978. the provisions of the Government in the Commission, or his designee, has This is the required notice. Sunshine Act, Public Law 94–409, that certified that, in his opinion, one or more of the exemptions set forth in 5 FOR FURTHER INFORMATION CONTACT: the Securities and Exchange Nadene G. Kennedy, Permit Office, Commission will hold a Closed Meeting U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) Office of Polar Programs, Rm. 755, on Friday, November 9, 2012 at 9:00 and 17 CFR 200.402(a)(3), (5), (7), 9(ii) National Science Foundation, 4201 a.m. and (10), permit consideration of the Wilson Boulevard, Arlington, VA 22230. Commissioners, Counsel to the scheduled matters at the Closed Commissioners, the Secretary to the Meeting. SUPPLEMENTARY INFORMATION: On October 3, 2012, the National Science Commission, and recording secretaries Commissioner Aguilar, as duty Foundation published a notice in the will attend the Closed Meeting. Certain officer, voted to consider the items Federal Register of a permit application staff members who have an interest in listed for the Closed Meeting in a closed received. A permit was issued on the matters also may be present. session. The General Counsel of the November 6, 2012 to: Mahlon C. Commission, or his designee, has The subject matter of the Closed Kennicutt, II; Permit No. 2013–022. certified that, in his opinion, one or Meeting scheduled for Thursday, Nadene G. Kennedy, more of the exemptions set forth in 5 November 8, 2012 will be: Permit Officer. U.S.C. 552b(c)(5), (7), 9(B) and (10) and Institution and settlement of injunctive [FR Doc. 2012–27377 Filed 11–8–12; 8:45 am] 17 CFR 200.402(a)(5), (7), 9(ii) and (10), actions; institution and settlement of BILLING CODE 7555–01–P permit consideration of the scheduled administrative proceedings; and a litigation matters at the Closed Meeting. matter. Commissioner Aguilar, as duty SECURITIES AND EXCHANGE officer, voted to consider the items At times, changes in Commission COMMISSION listed for the Closed Meeting in a closed priorities require alterations in the session and determined that no earlier scheduling of meeting items. Sunshine Act Meeting notice thereof was possible. For further information and to The subject matter of the Closed ascertain what, if any, matters have been Meeting scheduled for Thursday, Notice is hereby given, pursuant to added, deleted or postponed, please the provisions of the Government in the November 8, 2012 will be: contact: Sunshine Act, Public Law 94–409, that Institution and settlement of injunctive the Securities and Exchange actions; The Office of the Secretary at (202) Commission will host the SEC Institution and settlement of administrative 551–5400. proceedings; Government-Business Forum on Small Dated: November 7, 2012. Business Capital Formation on At times, changes in Commission Elizabeth M. Murphy, Thursday, November 15, 2012, priorities require alterations in the Secretary. beginning at 9:00 a.m. in the auditorium scheduling of meeting items. of the Commission’s headquarters at 100 For further information and to [FR Doc. 2012–27530 Filed 11–7–12; 4:15 pm] F Street NE., Washington, DC. Doors ascertain what, if any, matters have been BILLING CODE 8011–01–P

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SECURITIES AND EXCHANGE proposed rule change. The text of these to reinstate its effectiveness until July COMMISSION statements may be examined at the 10, 2015 and make [sic] conforming places specified in Item IV below. The changes to rule cross-references. By its [Release No. 34–68153; File No. SR– NASDAQ–2012–124] Exchange has prepared summaries, set terms, the effectiveness of the rule had forth in Sections A, B, and C below, of lapsed on July 10, 2011. NASDAQ is Self-Regulatory Organizations; The the most significant aspects of such reinstating the rule in order to ensure NASDAQ Stock Market LLC; Notice of statements. that NASDAQ has the same exemptive authority as FINRA with regard to the Filing and Immediate Effectiveness of A. Self-Regulatory Organization’s application of OATS rules, to ensure Proposed Rule Change, as Modified by Statement of the Purpose of, and that its respective members are not Amendment No. 1 Thereto, To Amend Statutory Basis for, the Proposed Rule subject to disparate requirements.5 Several NASDAQ Rules To Reflect Change Changes to Rules of the Financial NASDAQ is also making changes to rule Industry Regulatory Authority 1. Purpose text to conform to changes to 6 (‘‘FINRA’’) Many of NASDAQ’s rules governing corresponding FINRA rules. member conduct are based on rules of (3) NASDAQ is redesignating Rule November 5, 2012. FINRA (formerly the National 2110 as Rule 2010A (Standards of Pursuant to Section 19(b)(1) of the Association of Securities Dealers Commercial Honor and Principles of Securities Exchange Act of 1934 Trade) and deleting IM–2110–1 1 2 (‘‘NASD’’)). During 2008, FINRA 7 (‘‘Act’’), and Rule 19b–4 thereunder, embarked on an extended process of (Reserved). NASDAQ notes that in some notice is hereby given that on October moving rules formerly designated as instances, the amended rules reference 22, 2012, The NASDAQ Stock Market ‘‘NASD Rules’’ into a consolidated rules that are being adopted by LLC (‘‘Exchange’’), filed with the FINRA rulebook. In most cases, FINRA contemporaneous NASDAQ rule filings Securities and Exchange Commission has renumbered these rules, and in that have been filed on an immediately (‘‘Commission’’) the proposed rule some cases has substantively amended effective basis.8 change as described in Items I, II, and them. Accordingly, NASDAQ has also III below, which Items have been been undertaking a process of modifying 2. Statutory Basis prepared by the Exchange. On October its rulebook to ensure that NASDAQ 26, 2012, the Exchange submitted The Exchange believes that the rules corresponding to FINRA/NASD proposed rule change is consistent with Amendment No. 1 to the proposed rule rules continue to mirror them as closely change.3 The Commission is publishing the provisions of Section 6 of the Act,9 as practicable. To the extent possible, in general, and with Section 6(b)(5) of this notice to solicit comments on the NASDAQ will designate a NASDAQ proposed rule change, as modified by the Act,10 in particular, in that the rule that is intended to parallel a FINRA proposal is designed to prevent Amendment No. 1 thereto, from rule with the suffix ‘‘A’’. For example, interested persons. fraudulent and manipulative acts and the NASDAQ rule paralleling FINRA practices, to promote just and equitable I. Self-Regulatory Organization’s Rule 5320 will be designated as Rule principles of trade, to foster cooperation Statement of the Terms of the Substance 5320A. This filing makes the following and coordination with persons engaged of the Proposed Rule Change changes: in regulating, clearing, settling, The Exchange proposes to amend (1) NASDAQ is redesignating IM– processing information with respect to, several NASDAQ rules to reflect 2110–2 (Trading Ahead of Customer and facilitating transactions in changes to rules of the Financial Limit Order) and Rule 2111 (Trading securities, to remove impediments to Industry Regulatory Authority Ahead of Customer Market Orders) as and perfect the mechanism of a free and (‘‘FINRA’’). NASDAQ will implement NASDAQ Rule 5320A, which open market and a national market the proposed rule change thirty days incorporates FINRA Rule 5320 system, and, in general, to protect (Prohibition Against Trading Ahead of after the date of the filing. The text of 4 investors and the public interest. The the proposed rule change is available at Customer Orders) by reference. FINRA proposed changes will conform various http://nasdaq.cchwallstreet.com, at Rule 5320.02(b) and the reference to NASDAQ Rules to changes made to Rule 6420 contained therein, which NASDAQ’s principal office, and at the corresponding FINRA rules, thus relate to over-the-counter equity Commission’s Public Reference Room. promoting application of consistent securities, will not be reflected in regulatory standards with respect to II. Self-Regulatory Organization’s NASDAQ’s rule since NASDAQ, unlike rules that FINRA enforces pursuant to Statement of the Purpose of, and FINRA, does not regulate the over-the- its regulatory services agreement with Statutory Basis for, the Proposed Rule counter market. NASDAQ. Change (2) NASDAQ is redesignating Rules In its filing with the Commission, the 6950, 6951, 6952, 6953, 6954, 6955, and B. Self-Regulatory Organization’s Exchange included statements 6956 as Rules 7400A (Order Audit Trail Statement on Burden on Competition concerning the purpose of and basis for System), 7410A (Definitions), 7420A The Exchange does not believe that the proposed rule change and discussed (Applicability), 7430A (Synchronization the proposed rule change will result in any comments it received on the of Member Business Clocks), 7440A (Recording of Order Information), 5 The Commission notes that no retroactive 1 15 U.S.C. 78s(b)(1). 7450A (Order Data Transmission coverage is granted to Nasdaq for any actions taken under this Rule during its lapsed period. 2 17 CFR 240.19b–4. Requirements), and 7460A (Violation of 6 See Securities Exchange Act Release No. 58643 3 In Amendment No. 1, the Exchange amended Order Audit Trail System Rules). (September 25, 2008), 73 FR 57174 (October 1, Exhibit 1 to: (1) Explain the lapse of effectiveness NASDAQ is also deleting Rule 6957 2008) (SR–FINRA–2008–021, –022, –026, –028, of Nasdaq Rule 6958; (2) redesignate Rule 6958 as (Effective Date), redesignating Rule 6958 –029). Rule 7470A; and (3) reinstate that Rule’s 7 effectiveness to grant Nasdaq exemptive authority as Rule 7470A, and amending that rule Id. with regard to the application of OATS rules. In 8 See SR–NASDAQ–2012–122 (October 22, 2012); addition, the Exchange made technical amendments 4 See Securities Exchange Act Release No. 63895 SR–NASDAQ–2012–123 (October 22, 2012). to Exhibit 5 to reflect that prior Rule 6958 is being (February 11, 2011), 76 FR 9386 (February 17, 2011) 9 15 U.S.C. 78f. redesignated as Rule 7470A. (SR–FINRA–2009–090). 10 15 U.S.C. 78f(b)(5).

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any burden on competition that is not Number SR–NASDAQ–2012–124 on the SECURITIES AND EXCHANGE necessary or appropriate in furtherance subject line. COMMISSION of the purposes of the Act, as amended. Paper Comments C. Self-Regulatory Organization’s [Release No. 34–68159; File No. SR–NSCC– Statement on Comments on the • Send paper comments in triplicate 2012–08] Proposed Rule Change Received From to Elizabeth M. Murphy, Secretary, Members, Participants, or Others Securities and Exchange Commission, Self-Regulatory Organizations; The 100 F Street NE., Washington, DC National Securities Clearing Written comments were neither Corporation; Notice of Filing and solicited nor received. 20549–1090. Immediate Effectiveness of Proposed III. Date of Effectiveness of the All submissions should refer to File Rule Change To Modify Rule 52 Proposed Rule Change and Timing for Number SR–NASDAQ–2012–124. This (Mutual Fund Services) and Addendum Commission Action file number should be included on the A (NSCC’s Fee Structure) subject line if email is used. To help the The proposed rule change is effective Commission process and review your November 5, 2012. upon filing pursuant to Section comments more efficiently, please use 19(b)(3)(A) of the Act 11 and paragraph Pursuant to Section 19(b)(1) of the (f)(6) of Rule 19b–4 thereunder,12 in that only one method. The Commission will Securities Exchange Act of 1934 the proposed rule change: (i) Does not post all comments on the Commission’s (‘‘Act’’),1 notice is hereby given that on significantly affect the protection of Internet Web site (http://www.sec.gov/ October 22, 2012, the National investors or the public interest; (ii) does rules/sro.shtml). Copies of the Securities Clearing Corporation not impose any significant burden on submission, all subsequent (‘‘NSCC’’) filed with the Securities and competition; and (iii) does not become amendments, all written statements Exchange Commission (‘‘Commission’’) operative for 30 days after the date of with respect to the proposed rule the proposed rule change described in the filing, or such shorter time as the change that are filed with the Items I and II below, which Items have Commission may designate if consistent Commission, and all written been prepared primarily by NSCC. with the protection of investors and the communications relating to the NSCC filed the proposal pursuant to public interest; provided the self- proposed rule change between the Section 19(b)(3)(A)(iii) 2 of the Act, Rule regulatory organization has given the Commission and any person, other than 19b-4(f)(2),3 and Rule 19b-4(f)(4)(i) 4 Commission written notice of its intent those that may be withheld from the thereunder so that the proposal was to file the proposed rule change, along public in accordance with the effective upon filing with the with a brief description and text of the provisions of 5 U.S.C. 552, will be Commission. The Commission is proposed rule change, at least five available for Web site viewing and publishing this notice to solicit business days prior to the date of filing printing in the Commission’s Public of the proposed rule change, or such comments on the rule change from Reference Room on official business interested parties. shorter time as designated by the days between the hours of 10:00 a.m. Commission. and 3:00 p.m. Copies of such filing also I. Self-Regulatory Organization’s At any time within 60 days of the will be available for inspection and Statement of the Terms of Substance of filing of the proposed rule change, the copying at the principal offices of the the Proposed Rule Change Commission summarily may Exchange. All comments received will temporarily suspend such rule change if The proposed rule change modifies be posted without change; the it appears to the Commission that such Rule 52 (Mutual Fund Services) and Commission does not edit personal action is necessary or appropriate in the Addendum A (NSCC’s Fee Structure) of identifying information from public interest, for the protection of NSCC’s Rules. investors, or otherwise in furtherance of submissions. You should submit only the purposes of the Act. If the information that you wish to make II. Self-Regulatory Organization’s Commission takes such action, the available publicly. All submissions Statement of the Purpose of, and Commission shall institute proceedings should refer to File Number SR– Statutory Basis for, the Proposed Rule to determine whether the proposed rule NASDAQ–2012–124, and should be Change should be approved or disapproved. submitted on or before November 30, 2012. In its filing with the Commission, IV. Solicitation of Comments NSCC included statements concerning For the Commission, by the Division of Interested persons are invited to the purpose of and basis for the Trading and Markets, pursuant to delegated proposed rule change and discussed any submit written data, views, and authority.13 arguments concerning the foregoing, comments it received on the proposed including whether the proposed rule Kevin M. O’Neill, rule change. The text of these statements change, as amended, is consistent with Deputy Secretary. may be examined at the places specified the Act. Comments may be submitted by [FR Doc. 2012–27356 Filed 11–8–12; 8:45 am] in Item IV below. NSCC has prepared any of the following methods: BILLING CODE 8011–01–P summaries, set forth in Sections (A), (B), Electronic Comments and (C) below, of the most significant aspects of these statements.5 • Use the Commission’s Internet comment form (http://www.sec.gov/ rules/sro.shtml); or 1 15 U.S.C. 78s(b)(1). • Send an email to rule- 2 15 U.S.C. 78s(b)(3)(A)(iii). [email protected]. Please include File 3 17 CFR 240.19b–4(f)(2). 4 17 CFR 240.19b–4(f)(4)(i). 11 15 U.S.C. 78s(b)(3)(A). 5 The Commission has modified the text of the 12 17 CFR 240.19b–4(f)(6). 13 17 CFR 200.30–3(a)(12). summaries prepared by NSCC.

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(A) Self-Regulatory Organization’s commission-related information from flow of funds is from the Fund to the Statement of the Purpose of, and the Funds to Distributors. Distributor, from the Distributor to the Statutory Basis for, the Proposed Rule The Proposed Rule Changes. There Fund, from a Distributor to another Change has been a growing trend in the mutual Distributor, or otherwise. fund industry toward omnibus c. Specify Omnibus Invoicing within Pursuant to the rule change proposal, processing, a practice pursuant to which the Service: NSCC proposes to specify in NSCC will (i) rename the ‘‘Mutual Fund Distributors maintain a single account at Rule 52 that the transmission of Commission Settlement’’ service under a Fund, which account represents commission and other fee data with Rule 52 (the ‘‘Service’’) as the ‘‘DTCC multiple investor positions of that regard to investor accounts held in Payment aXis’’ service in order to better Distributor in that Fund’s securities. Omnibus, and the settlement of align the name of the Service with the Where multiple investor positions are payments thereof, shall be included various commission and other fee data held in Omnibus, the Distributor within the suite of functionalities transmission and payment settlement maintains the individual investor offered by the Service. In all events, the functionalities available through the account records on the Distributor’s Fund or Distributor being debited will Service (i.e., not solely commission books and records. The trend toward either be the initiator of the commission settlement), (ii) make clear that the omnibus processing is anticipated to or other fee payment transaction, or will Service permits for the transmission of continue growing into the foreseeable otherwise confirm the debit that will be commission and other fee related data, future; however, invoicing for the fees charged against its account. and the settlement of such payments, related to these investor accounts is not d. Specify 12b–1 Fee Payment Process among users of the Service without standardized. The current state of fee with regard to Omnibus Invoicing: regard to whether the flow of funds is invoicing with regard to such investor NSCC will specify in Rule 52 the from the fund company (‘‘Fund’’) to the accounts is manually intensive, process for 12b–1 fee payments with retail broker-dealer (‘‘Distributor’’), from involving the exchange of reports and regard to investor accounts held in the Distributor to the Fund, from a spreadsheets via fax, email, and regular Omnibus. Unlike the process applicable Distributor to another Distributor, or mail, and the settlement of payments to all other commission and other fee otherwise, (iii) specify that commission thereof generally occurs by check or payments within the Service, 12b–1 fee and other fee data transmission, and the wire. Due to the lack of standardization payment instructions with regard to settlement of such payments, with and automation, the industry has sought investor accounts held in Omnibus in regard to investor accounts held on an NSCC’s assistance to create a all events must be initiated by the omnibus account basis at the Fund standardized file for omnibus invoicing. Distributor. When NSCC receives the (‘‘Omnibus’’) may be made through the As a result, NSCC has enhanced the 12b–1 fee payment instruction with Service, (iv) specify the process for the Service’s functionality to permit for fee regard to these accounts, NSCC will 6 payment of 12b–1 fees with regard to data transmission and settlement of transmit such instruction to the contra- investor accounts held in Omnibus, and payments with regard to investor side Fund. The contra-side Fund will (v) establish the fees that NSCC will accounts held in Omnibus. By this then either (i) confirm or reject the charge users of the Service with regard proposed rule change, NSCC seeks to do payment instruction, or (ii) release to investor accounts held in Omnibus. the following: settlement (either with or without a Background. The Service was initially a. Rename Service: The Service will confirmation). If NSCC receives a approved by the Commission on be renamed ‘‘DTCC Payment aXis’’ to confirmation or rejection instruction, December 9, 1992 (‘‘1992 Rule Filing’’).7 better represent the broadened NSCC will transmit such confirmation In the 1992 Rule Filing, NSCC described functionality of fee data exchange and or rejection to the initiating Distributor. that the new service would provide for settlement capabilities offered by the e. Establish Fees to be charged by the automation of payments of Service today, as opposed to its NSCC: NSCC proposes to update commissions owed in respect of mutual capabilities at initial implementation in Addendum A of its Rules and fund transactions, explaining that under 1992. Procedures to incorporate the fees the new service, Funds would be able to b. Clarify Scope of Commission and associated with omnibus invoicing. The transmit commission debit data to NSCC other Fee Data Transmission and Flow NSCC fees for omnibus invoicing will be on a daily basis. NSCC’s role in this new of Funds: Although the Service, as as follows: commission service would be to described in Rule 52, does not specify a. From 1 to 500,000 records $0.10 transmit data between the Funds (i.e., from whom and to whom the per 1 record. the payers of commission payments) transmission of commission and fee b. From 500,001 to 1,000,000 records and the Distributors (i.e., the receivers of related data, and settlement of such $0.08 per 1 record. commission payments). In 2005 (‘‘2005 payments, may be made, the previous c. More than 1,000,000 records $0.06 Rule Filing’’),8 NSCC expanded the rule filing descriptions do identify a per 1 record. scope of the Service to permit specific flow. In the 1992 Rule Filing, d. Monthly Fee $500. Distributors to submit fee data through the type of fee payment and the flow of As with all of NSCC’s Mutual Fund NSCC to other Distributors and to settle data and payments were specified to be Services, the Service is a non- the fee payments in respect thereof commission data and settlements by the guaranteed service of NSCC and shall through NSCC, expanding the Service to Fund to the Distributors. The 2005 Rule remain so after the effectiveness of this allow for more than the exchange of Filing expanded the scope to permit the proposed rule change. transmission of other fee payment data The proposed rule change is 6 This is a category of fees paid out by the Fund and settlement thereof by one consistent with the requirements of the out of Fund assets to cover distribution expenses Distributor to another Distributor. In the Act and the rules and regulations issued and sometimes shareholder service expenses. current rule filing, NSCC seeks to make thereunder applicable to NSCC because 7 Securities Exchange Act Release No. 34–31579 clear that the Service permits for the it will promote processing efficiencies (December 9, 1992), 57 FR 60018 (December 17, transmission of commission and other between Funds and Distributors, 1992). 8 Securities Exchange Act Release No. 34–52458 fee related data, and the settlement of thereby facilitating the prompt and (September 16, 2005), 70 FR 56200 (September 26, such payments, among users of the accurate processing of commission and 2005). Service without regard to whether the other fee related payment data

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transmissions and settlement with IV. Solicitation of Comments For the Commission by the Division of respect to such payments. Trading and Markets, pursuant to delegated Interested persons are invited to authority.12 (B) Self-Regulatory Organization’s submit written data, views, and Kevin M. O’Neill, Statement on Burden on Competition arguments concerning the foregoing, Deputy Secretary. including whether the proposed rule [FR Doc. 2012–27357 Filed 11–8–12; 8:45 am] NSCC does not believe that the change is consistent with the Act. proposed rule change will have any Comments may be submitted by any of BILLING CODE 8011–01–P impact or impose any burden on the following methods: competition. Electronic Comments SECURITIES AND EXCHANGE COMMISSION (C) Self-Regulatory Organization’s • Statement on Comments on the Use the Commission’s Internet comment form (http://www.sec.gov/ [Release No. 34–68158; File No. SR– Proposed Rule Change Received From rules/sro.shtml); or NYSEArca–2012–101] Members, Participants, or Others • Send an email to rule- Self-Regulatory Organizations; NYSE Written comments relating to the [email protected]. Please include File Arca, Inc.; Order Granting Approval of proposed rule change have not been Number SR–NSCC–2012–08 on the Proposed Rule Change To List and solicited or received. NSCC will notify subject line. Trade Shares of the PowerShares S&P the Commission of any written Paper Comments 500 Downside Hedged Portfolio Under comments received by NSCC. NYSE Arca Equities Rule 8.600 • Send paper comments in triplicate III. Date of Effectiveness of the to Elizabeth M. Murphy, Secretary, November 5, 2012. Proposed Rule Change and Timing for Securities and Exchange Commission, I. Introduction Commission Action 100 F Street NE., Washington, DC 20549–1090. On September 6, 2012, NYSE Arca, The foregoing proposed rule change Inc. (‘‘Exchange’’ or ‘‘NYSE Arca’’) filed has become effective upon filing All submissions should refer to File with the Securities and Exchange pursuant to Section 19(b)(3)(A)(iii) 9 of Number SR–NSCC–2012–08. This file Commission (‘‘Commission’’), pursuant the Act, Rule 19b–4(f)(2),10 and Rule number should be included on the to Section 19(b)(1) of the Securities 19b–4(f)(4)(i) 11 thereunder because it subject line if email is used. To help the Exchange Act of 1934 (‘‘Act’’ or effects changes in an existing service of Commission process and review your ‘‘Exchange Act’’) 1 and Rule 19b–4 NSCC that do not adversely affect the comments more efficiently, please use thereunder,2 a proposed rule change to safeguarding of securities or funds in only one method. The Commission will list and trade shares (‘‘Shares’’) of the the custody or control of NSCC or for post all comments on the Commission’s PowerShares S&P 500 Downside which NSCC is responsible and do not Internet Web site (http://www.sec.gov/ Hedged Portfolio (‘‘Fund’’) under NYSE significantly affect the respective rights rules/sro.shtml). Copies of the Arca Equities Rule 8.600. The proposed or obligations of NSCC or persons using submission, all subsequent rule change was published for comment the service. NSCC’s Mutual Fund amendments, all written statements in the Federal Register on September Services are non-guaranteed services, with respect to the proposed rule 24, 2012.3 The Commission received no and therefore, the funds in NSCC’s change that are filed with the comments on the proposed rule change. control are not adversely affected by the Commission, and all written This order grants approval of the proposed rule change. Further, the communications relating to the proposed rule change. proposed rule change does not provide proposed rule change between the any greater or lesser rights to or Commission and any person, other than II. Description of the Proposed Rule obligations on either NSCC or the users those that may be withheld from the Change of the Service in comparison to the public in accordance with the The Exchange proposes to list and current rights and obligations of the provisions of 5 U.S.C. 552, will be trade Shares of the Fund pursuant to respective parties with regard to the available for Web site viewing and NYSE Arca Equities Rule 8.600, which Service as it is currently offered. In printing in the Commission’s Public governs the listing and trading of addition, the proposed rule change Reference Room, 100 F Street NE., Managed Fund Shares on the Exchange. establishes fees charged by NSCC Washington, DC 20549, on official The Shares will be offered by applicable only to members. The business days between the hours of PowerShares Actively Managed implementation date for the proposals 10:00 a.m. and 3:00 p.m. Copies of such Exchange-Traded Fund Trust (‘‘Trust’’),4 in this proposed rule change filing other filings also will be available for a statutory trust organized under the than the change in the Service’s name inspection and copying at the principal will be December 1, 2012. office of NSCC and on NSCC’s Web site 12 17 CFR 200.30–3(a)(12). 1 At any time within 60 days of the at http://www.dtcc.com/downloads/ 15 U.S.C. 78s(b)(1). _ 2 17 CFR 240.19b–4. filing of the proposed rule change, the legal/rule filings/2012/nscc/SR-NSCC- 2012-08.pdf. 3 See Securities Exchange Act Release No. 67881 Commission summarily may (September 18, 2012), 77 FR 58889 (‘‘Notice’’). temporarily suspend such rule change if All comments received will be posted 4 The Trust is registered under the Investment it appears to the Commission that such without change; the Commission does Company Act of 1940 (‘‘1940 Act’’). On August 14, action is necessary or appropriate in the not edit personal identifying 2012, the Trust filed with the Commission a post- information from submissions. You effective amendment to Form N–1A under the public interest, for the protection of Securities Act of 1933 (‘‘Securities Act’’) and under investors, or otherwise in furtherance of should submit only information that the 1940 Act relating to the Fund (File Nos. 333– the purposes of the Act. you wish to make available publicly. All 147622 and 811–22148) (‘‘Registration Statement’’). submissions should refer to File In addition, the Commission has issued an order Number SR–NSCC–2012–08 and should granting certain exemptive relief to the Trust under 9 15 U.S.C. 78s(b)(3)(A)(iii). the 1940 Act. See Investment Company Act Release 10 17 CFR 240.19b–4(f)(2). be submitted on or before November 30, No. 28171 (February 27, 2008) (File No. 812– 11 17 CFR 240.19b–4(f)(4)(i). 2012. 13386).

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laws of the State of Delaware and rolls the nearest month VIX futures cap U.S. stocks over 30 days in the registered with the Commission as an contracts to the next month VIX futures future, and is calculated based on the open-end management investment contracts on a daily basis in equal prices of certain put and call options on company. The investment adviser to the fractional amounts. the S&P 500 Index. The VIX Index Fund is Invesco PowerShares Capital Following the proprietary formula of measures the premium paid by investors Management LLC (‘‘Adviser’’). The Bank Standard & Poor’s (‘‘S&P’’ or ‘‘Index for certain options linked to the S&P 500 of New York Mellon Corporation is the Provider’’), under normal circumstances Index. During periods of market administrator, custodian, and transfer (i.e., times other than when the instability, the implied level of volatility agent for the Fund, and Invesco Benchmark’s stop-loss process is of the S&P 500 Index typically increases Distributors, Inc. is the distributor for triggered, as described below), the and, consequently, the prices of options the Fund Shares. The Exchange states allocation to the VIX Futures Index linked to the S&P 500 Index typically that the Adviser is affiliated with a constitutes between 2.5% and 40% of increase (assuming all other relevant broker-dealer and has implemented a the Benchmark, with equity securities factors remain constant or have fire wall with respect to its broker- contained in the S&P 500 Index negligible changes). This, in turn, causes dealer affiliate regarding access to composing the remainder. The the level of the VIX Index to increase. information concerning the composition allocation to the VIX Futures Index The VIX Index historically has had and/or changes to the Fund’s portfolio.5 generally increases when realized negative correlations to the S&P 500 The Fund will be an actively managed volatility and implied volatility are Index. exchange-traded fund that will seek to higher, and decreases when realized Investments achieve positive total returns in rising or volatility and implied volatility are falling markets that are not directly lower. With respect to the stop-loss The Fund, in accordance with strategy correlated to broad equity or fixed process, in the event losses on the allocation rules provided by the Index income market returns. The Fund will Benchmark over the previous five Provider, will invest in a combination of seek to achieve its investment objective business days are greater than 2%, the equity securities contained in the S&P by using a quantitative, rules-based Benchmark moves its entire allocation 500 Index and that are listed on a U.S. strategy designed to provide returns that to cash. Unless the stop-loss is in place, securities exchange; VIX Index Related correspond to the performance of the the Benchmark is entirely allocated to a Instruments; money market instruments; S&P 500 Dynamic VEQTOR Index combination of the S&P 500 Index and cash; cash equivalents; and E-mini S&P (‘‘Benchmark’’). The Fund’s Benchmark the VIX Futures Index. While 500 Futures that are listed on the allocates between equity securities and allocations are reviewed daily, these Chicago Mercantile Exchange (‘‘CME’’).8 CBOE Volatility Index futures. The allocations may change on a less The allocation among the Fund’s Fund seeks to gain exposure to equity frequent basis. securities contained in the S&P 500 investments will approximate the The Benchmark’s allocation to the allocation among the components of the Index, CBOE Volatility Index (‘‘VIX VIX Futures Index serves as an implied Index’’) related instruments (as Benchmark. Accordingly, during volatility hedge as volatility historically periods of low volatility, a greater described in more detail below, ‘‘VIX tends to correlate negatively to the Index Related Instruments’’), money portion of the Fund’s assets will be performance of the U.S. equity markets invested in equity securities, and during market instruments, cash, cash (i.e., rapid declines in the performance equivalents, and futures contracts that periods of increased volatility, a greater of the U.S. equity markets generally are portion of the Fund’s assets will be track the S&P 500 Index (‘‘E-mini S&P associated with particularly high 500 Futures’’). invested in VIX Index Related volatility in such markets). ‘‘Implied Instruments. However, the Fund will be The Benchmark, the VIX Index, and the volatility’’ is a measure of the expected actively managed, and, although the S&P 500 VIX Short Term Futures Index volatility of the S&P 500 Index that is Fund will seek performance comparable The Benchmark is comprised of three reflected by the value of the VIX Index. to the Benchmark, the Fund may have types of components at any given time: The U.S. Index Committee of the a higher or lower exposure to any Index Provider maintains the An equity component, represented by 7 component within the Benchmark at the S&P 500 Index; a volatility Benchmark. That Committee meets any time. monthly. At each meeting, the component, represented by the S&P 500 VIX Index Related Instruments that VIX Short Term Futures Index (‘‘VIX Committee reviews pending corporate actions that may affect Benchmark the Fund will invest in include listed Futures Index’’); and cash, represented VIX futures contracts contained in the by the overnight London Interbank constituents, statistics comparing the composition of the Benchmark to the VIX Futures Index or exchange-traded Offered Rate.6 The VIX Futures Index 9 market, companies that are being funds (‘‘ETFs’’) and exchange-traded utilizes the prices of the first and second 10 considered as candidates for addition to notes (‘‘ETNs’’) that are listed on a month futures contracts based on the U.S. securities exchange and provide VIX Index, replicating a position that the Benchmark, and any significant market events. In addition, the exposure to the VIX Index. All of the

5 Committee may revise the Benchmark’s See NYSE Arca Equities Rule 8.600, 8 Commentary .06. In the event (a) the Adviser policy covering rules for selecting The Fund will be ‘‘non-diversified’’ under the becomes newly affiliated with a broker-dealer, or (b) companies, treatment of dividends, 1940 Act and may invest more of its assets in fewer any new adviser or sub-adviser becomes affiliated issuers than ‘‘diversified’’ funds. The diversification with a broker-dealer, it will implement a fire wall share counts, or other matters. standard is set forth in Section 5(b)(1) of the 1940 with respect to such broker-dealer regarding access The VIX Index is a theoretical Act. to information concerning the composition and/or calculation and cannot be traded. It is a 9 For purposes of this proposed rule change, ETFs changes to the portfolio, and will be subject to benchmark index designed to measure are securities registered under the 1940 Act such as procedures designed to prevent the use and those listed and traded on the Exchange under dissemination of material non-public information the market price of volatility in large NYSE Arca Equities Rules 5.2(j)(3), 8.100, and regarding such portfolio. 8.600. 6 As of June 30, 2012, the Benchmark allocation 7 The Index Provider is not a broker-dealer and 10 For purposes of this proposed rule change, was as follows: 97.5% to the equity component, has implemented procedures designed to prevent ETNs are securities registered under the Securities represented by the S&P 500 Index; 2.5% to the VIX the use and dissemination of material, non-public Act such as those listed and traded on the Exchange Futures Index; and 0% allocated to cash. information regarding the Index. under NYSE Arca Equities Rule 5.2(j)(6).

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VIX Index Related Instruments will be investments would be consolidated into 500 Futures. Stock index contracts are listed on a U.S. exchange. the Fund’s financial statements. The futures based on indices that reflect the Futures contracts on the VIX Index Fund’s and Subsidiary’s investments market value of common stock of the have expirations ranging from the near would be disclosed on the Fund’s Web firms included in the indices. The Fund month consecutively out to the tenth site on a daily basis. Should the Fund may enter into U.S.-listed futures month. Futures on the VIX Index invest in the Subsidiary, it would be contracts to purchase security indices provide investors the ability to invest in expected to provide the Fund with when the Adviser anticipates forward market volatility based on their exposure to investment returns from purchasing the underlying securities view of the future direction or VIX Index futures contracts within the and believes prices will rise before the movement of the VIX Index. Because the limits of the federal tax requirements purchase will be made. VIX Index is not a tangible item that can applicable to investment companies, To the extent the Fund uses futures it be purchased and sold directly, a such as the Fund. will do so only in accordance with Rule futures contract on the VIX Index The Subsidiary would be able to 4.5 of the CEA.12 Under recently provides for the payment and receipt of invest in VIX Index futures, as well as adopted amendments to Rule 4.5, an cash based on the level of the VIX Index other investments that would serve as investment adviser of a registered at settlement or liquidation of the margin or collateral or otherwise investment company may claim contract. support the Subsidiary’s VIX Index exclusion from registration as a The Fund may invest a portion of its futures positions. The Subsidiary would commodity pool operator (‘‘CPO’’) only assets in high-quality money market be subject to the same general if the registered investment company it instruments, cash, and cash equivalents investment policies and restrictions as advises uses futures contracts solely for to provide liquidity, to collateralize its the Fund, except that, unlike the Fund ‘‘bona fide hedging purposes’’ or limits futures contracts investments, or to (which is subject to Rule 4.5 of the its use of futures contracts for non-bona track the Benchmark during times when Commodity Exchange Act (‘‘CEA’’)), the fide hedging purposes in specified the Benchmark moves its entire Subsidiary would be able to invest ways. Because the Fund does not expect allocation to cash. The instruments in without limitation in VIX Index futures to use futures contracts solely for ‘‘bona which the Fund may invest include: (i) and may use leveraged investment fide hedging purposes,’’ effective Short-term obligations issued by the techniques. Otherwise, references to the December 31, 2012, the Fund will be U.S. Government; 11 (ii) short-term investment strategies of the Fund for subject to rules that will require it to negotiable obligations of commercial non-equity investments include the limit its use of positions in futures banks, fixed time deposits, and bankers’ investment strategies of the Subsidiary. contracts in accordance with the acceptances of U.S. and foreign banks The Fund may utilize the Subsidiary, requirements of amended Rule 4.5, and similar institutions; (iii) commercial but is not required to do so. If it is unless it otherwise complies with CPO paper rated at the date of purchase utilized, the Subsidiary will not be regulation. ‘‘Prime-1’’ by Moody’s Investors registered under the 1940 Act. The The Fund may enter into repurchase Service, Inc., or ‘‘A–1+’’ or ‘‘A–1’’ by Fund, as the sole shareholder of the agreements, which are agreements S&P, or has a similar rating from a Subsidiary, will not have the pursuant to which securities are comparable rating agency, or, if unrated, protections offered to investors in acquired by the Fund from a third party of comparable quality as determined by registered investment companies. with the understanding that they will be the Adviser; and (iv) money market However, because the Fund wholly repurchased by the seller at a fixed price mutual funds. owns and controls the Subsidiary, and on an agreed date. These agreements The Fund also may invest in E-mini the Fund and the Subsidiary will be may be made with respect to any of the S&P 500 Futures that are listed on the managed by the Adviser, it is unlikely portfolio securities in which the Fund is CME. E-mini S&P 500 Futures are that the Subsidiary will take action authorized to invest. Repurchase futures contracts that track the S&P 500 contrary to the interests of the Fund or agreements may be characterized as Index. They are substantially similar to the Fund’s shareholders. The Board of loans secured by the underlying traditional futures contracts on the S&P Trustees of the Trust (‘‘Board’’) will securities. The Fund may enter into 500 Index, except that the notional have oversight responsibility for the repurchase agreements with: (i) Member value of E-mini S&P 500 Futures are investment activities of the Fund, banks of the Federal Reserve System one-fifth the size of their larger including its investment in the having total assets in excess of $500 counterpart futures contracts. Subsidiary, and the Fund’s role as the million; and (ii) securities dealers sole shareholder of the Subsidiary. Also, (‘‘Qualified Institutions’’). The Adviser The Subsidiary in managing the Subsidiary’s portfolio, will monitor the continued The Fund may gain exposure to the the Adviser will be subject to the same creditworthiness of Qualified VIX Index futures markets through investment restrictions and operational Institutions. investments in a subsidiary organized in guidelines that apply to the The Fund may enter into reverse the Cayman Islands (‘‘Subsidiary’’). management of the Fund. repurchase agreements, which involve Should the Fund invest in the the sale of securities with an agreement Other Investments Subsidiary, that investment may not to repurchase the securities at an exceed 25% of the Fund’s total assets at In addition to the VIX Index futures agreed-upon price, date, and interest the end of each tax year quarter. The contracts and E-mini S&P 500 Futures payment and have the characteristics of Subsidiary would be wholly-owned and that are part of its primary investments, borrowing. The securities purchased controlled by the Fund, and its the Fund may enter into other U.S.- with the funds obtained from the listed futures contracts on the S&P 500 agreement and securities collateralizing 11 The Fund may invest in short-term obligations Index. The Fund will not use futures for issued or guaranteed by the U.S. Government, its speculative purposes. The Fund will 12 The Trust, on behalf of the Fund, has filed a agencies and instrumentalities, including bills, only enter into futures contracts that are notice of eligibility for exclusion from the definition notes, and bonds issued by the U.S. Treasury, as of the term ‘‘commodity pool operator’’ in well as ‘‘stripped’’ or ‘‘zero coupon’’ U.S. Treasury traded on U.S. exchanges. accordance with Rule 4.5 of the CEA so that the obligations representing future interest or principal The Fund may invest in stock index Fund is not subject to registration or regulation as payments on U.S. Treasury notes or bonds. contracts, in addition to the E-mini S&P a CPO under the CEA.

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the agreement will have maturity dates III. Discussion and Commission’s end of the business day.20 The NAV of no later than the repayment date. Findings the Fund will be determined at the close of regular trading (ordinarily 4:00 p.m. In addition to the ETFs and ETNs that After careful review, the Commission are listed on U.S. exchanges and finds that the proposed rule change is Eastern Time) every day the New York provide exposure to the VIX Index, the consistent with the requirements of Stock Exchange is open. Information Fund may invest in the securities of Section 6 of the Act 15 and the rules and regarding market price and trading other investment companies (including regulations thereunder applicable to a volume of the Shares will be continually money market funds) to the extent national securities exchange.16 In available on a real-time basis throughout permitted under the 1940 Act. The Fund particular, the Commission finds that the day on brokers’ computer screens also may purchase warrants. the proposed rule change is consistent and other electronic services. The Fund does not expect to invest in with Section 6(b)(5) of the Act,17 which Information regarding the previous options or enter into swap agreements, requires, among other things, that the day’s closing price and trading volume including credit default swaps, but may Exchange’s rules be designed to prevent information for the Shares will be do so if such investments are in the best fraudulent and manipulative acts and published daily in the financial section interests of the Fund’s shareholders. practices, to promote just and equitable of newspapers. The intra-day, closing Investment Limitations principles of trade, to foster cooperation and settlement prices of the portfolio and coordination with persons engaged investments (e.g., futures contracts, The Fund’s investments will be in facilitating transactions in securities, equity securities, ETFs, and ETNs) are consistent with the Fund’s investment to remove impediments to and perfect also readily available from the national objective and will not be used to the mechanism of a free and open securities exchanges trading such enhance leverage. The Fund will not market and a national market system, securities, automated quotation systems, invest in equities that are traded over- and, in general, to protect investors and published or other public sources, or the-counter (‘‘OTC’’) or equities listed the public interest. The Commission on-line information services such as on a non-U.S. exchange, or enter into notes that the Fund and the Shares must Bloomberg or Reuters. The Fund’s Web futures that are not traded on a U.S. comply with the requirements of NYSE site will include a form of the Arca Equities Rule 8.600 to be listed and exchange. prospectus for the Fund and additional traded on the Exchange. The Fund may hold up to an aggregate data relating to NAV and other amount of 15% of its net assets in The Commission finds that the applicable quantitative information. illiquid securities (calculated at the time proposal to list and trade the Shares on The Commission further believes that of investment), including 144A the Exchange is consistent with Section Securities. The Fund will monitor its 11A(a)(1)(C)(iii) of the Act,18 which sets the proposal to list and trade the Shares portfolio liquidity on an ongoing basis forth Congress’s finding that it is in the is reasonably designed to promote fair to determine whether, in light of current public interest and appropriate for the disclosure of information that may be circumstances, an adequate level of protection of investors and the necessary to price the Shares liquidity is being maintained, and will maintenance of fair and orderly markets appropriately and to prevent trading consider taking appropriate steps in to assure the availability to brokers, when a reasonable degree of order to maintain adequate liquidity if, dealers, and investors of information transparency cannot be assured. The through a change in values, net assets, with respect to quotations for, and Commission notes that the Exchange or other circumstances, more than 15% transactions in, securities. Quotation will obtain a representation from the of the Fund’s net assets are held in and last-sale information for the Shares issuer of the Shares that the NAV per illiquid securities and other illiquid will be available via the Consolidated Share will be calculated daily and that assets. Tape Association (‘‘CTA’’) high-speed the NAV and the Disclosed Portfolio The Fund may not concentrate its line. In addition, the Portfolio Indicative will be made available to all market 21 investments (i.e., invest more than 25% Value, as defined in NYSE Arca Equities participants at the same time. In of the value of its total assets in Rule 8.600(c)(3), will be widely addition, trading in the Shares will be securities of issuers in any one industry disseminated by one or more major subject to NYSE Arca Equities Rule or group of industries). This restriction market data vendors at least every 15 8.600(d)(2)(D), which sets forth seconds during the Core Trading circumstances under which Shares of does not apply to obligations issued or 19 guaranteed by the U.S. Government, its Session. On each business day, before the Fund may be halted. The Exchange agencies, or instrumentalities. The Fund commencement of trading in Shares in may halt trading in the Shares if trading intends to qualify for and to elect to be the Core Trading Session on the is not occurring in the securities and/or treated as a separate regulated Exchange, the Fund will disclose on its the financial instruments comprising investment company under Subchapter Web site the Disclosed Portfolio, as the Disclosed Portfolio of the Fund, or defined in NYSE Arca Equities Rule M of the Internal Revenue Code.13 if other unusual conditions or 8.600(c)(2), held by the Fund and the circumstances detrimental to the Additional information regarding the Subsidiary that will form the basis for maintenance of a fair and orderly Trust, the Fund, and the Shares, the Fund’s calculation of NAV at the including investment strategies, risks, 20 On a daily basis, the Adviser will disclose for creation and redemption procedures, 15 15 U.S.C. 78f. each portfolio security and other financial net asset value (‘‘NAV’’), fees, portfolio 16 In approving this proposed rule change, the instrument of the Fund and the Subsidiary, if holdings disclosure policies, Commission notes that it has considered the applicable, the following information on the Fund’s distributions, and taxes, among other proposed rule’s impact on efficiency, competition, Web site: Ticker symbol (if applicable); name of things, is included in the Notice and and capital formation. See 15 U.S.C. 78c(f). security and financial instrument; number of shares 17 Registration Statement, as applicable.14 15 U.S.C. 78f(b)(5). or dollar value of each security and financial 18 15 U.S.C. 78k–1(a)(1)(C)(iii). instrument held in the portfolio; and percentage 19 According to the Exchange, several major weighting of the security and financial instrument 13 See 26 U.S.C. 851. market data vendors widely disseminate Portfolio in the portfolio. The Web site information will be 14 See Notice and Registration Statement, supra Indicative Values taken from CTA or other data publicly available at no charge. notes 3 and 4, respectively. feeds. 21 See NYSE Arca Equities Rule 8.600(d)(1)(B).

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market are present.22 Further, the The Exchange represents that the investments are in the best interests of Commission notes that the Reporting Shares are deemed to be equity the Fund’s shareholders. The Fund’s Authority that provides the Disclosed securities, thus rendering trading in the investments will be consistent with its Portfolio must implement and maintain, Shares subject to the Exchange’s investment objective and will not be or be subject to, procedures designed to existing rules governing the trading of used to enhance leverage. equity securities. In support of this prevent the use and dissemination of (7) The Fund may hold up to an material non-public information proposal, the Exchange has made aggregate amount of 15% of its net regarding the actual components of the representations, including: assets in illiquid securities (calculated portfolio.23 All equity securities, ETFs, (1) The Shares will be subject to at the time of investment), including and ETNs in which the Fund invests NYSE Arca Equities Rule 8.600, which Rule 144A securities. will be listed on a U.S. securities sets forth the initial and continued exchange. The Exchange may obtain listing criteria applicable to Managed (8) Should the Fund invest in the information via the Intermarket Fund Shares. Subsidiary, that investment may not Surveillance Group (‘‘ISG’’) from other (2) The Exchange has appropriate exceed 25% of the Fund’s total assets at exchanges that are members of ISG or rules to facilitate transactions in the the end of each tax year quarter. with which the Exchange has in place Shares during all trading sessions. (3) The Exchange’s surveillance (9) A minimum of 100,000 Shares of a comprehensive surveillance sharing the Fund will be outstanding at the agreement. In addition, the Exchange procedures applicable to derivative products, which include Managed Fund commencement of trading on the could obtain information from the U.S. Exchange. futures exchanges, all of which are ISG Shares, are adequate to properly members, on which futures held by the monitor Exchange trading of the Shares This approval order is based on all of Fund are listed and traded. The in all trading sessions and to deter and the Exchange’s representations and detect violations of Exchange rules and Exchange states that it has a general description of the Fund, including those applicable federal securities laws. 26 policy prohibiting the distribution of set forth above and in the Notice. (4) Prior to the commencement of material, non-public information by its trading, the Exchange will inform its For the foregoing reasons, the employees. The Exchange also states Equity Trading Permit (‘‘ETP’’) Holders Commission finds that the proposed that the Adviser is affiliated with a in an Information Bulletin of the special rule change is consistent with Section broker-dealer, and the Adviser has characteristics and risks associated with 6(b)(5) of the Act 27 and the rules and implemented a fire wall with respect to trading the Shares. Specifically, the regulations thereunder applicable to a its broker-dealer affiliate regarding Information Bulletin will discuss the national securities exchange. access to information concerning the following: (a) The procedures for IV. Conclusion composition and/or changes to the purchases and redemptions of Shares in portfolio.24 Creation Units (and that Shares are not It is therefore ordered, pursuant to individually redeemable); (b) NYSE 28 22 See NYSE Arca Equities Rule 8.600(d)(2)(C) Section 19(b)(2) of the Act, that the (providing additional considerations for the Arca Equities Rule 9.2(a), which proposed rule change (SR–NYSEArca– suspension of trading in or removal from listing of imposes a duty of due diligence on its 2012–101) be, and it hereby is, Managed Fund Shares on the Exchange). With ETP Holders to learn the essential facts approved. respect to trading halts, the Exchange may consider relating to every customer prior to other relevant factors in exercising its discretion to For the Commission, by the Division of halt or suspend trading in the Shares of the Fund. trading the Shares; (c) the risks involved in trading the Shares during the Trading and Markets, pursuant to delegated Trading in Shares of the Fund will be halted if the 29 circuit breaker parameters in NYSE Arca Equities Opening and Late Trading Sessions authority. Rule 7.12 have been reached. Trading also may be when an updated Portfolio Indicative Kevin M. O’Neill, halted because of market conditions or for reasons that, in the view of the Exchange, make trading in Value will not be calculated or publicly Deputy Secretary. the Shares inadvisable. disseminated; (d) how information [FR Doc. 2012–27364 Filed 11–8–12; 8:45 am] 23 See NYSE Arca Equities Rule 8.600(d)(2)(B)(ii). regarding the Portfolio Indicative Value BILLING CODE 8011–01–P 24 See supra note 5. The Commission notes that is disseminated; (e) the requirement that an investment adviser to an open-end fund is ETP Holders deliver a prospectus to required to be registered under the Investment Advisers Act of 1940 (‘‘Advisers Act’’). As a result, investors purchasing newly issued the Adviser and its related personnel are subject to Shares prior to or concurrently with the the provisions of Rule 204A–1 under the Advisers confirmation of a transaction; and (f) Act relating to codes of ethics. This Rule requires trading information. investment advisers to adopt a code of ethics that reflects the fiduciary nature of the relationship to (5) For initial and/or continued clients as well as compliance with other applicable listing, the Fund must be in compliance securities laws. Accordingly, procedures designed with Rule 10A–3 under the Exchange to prevent the communication and misuse of non- Act,25 as provided by NYSE Arca 26 The Commission notes that it does not regulate public information by an investment adviser must Equities Rule 5.3. the market for futures in which the Fund plans to be consistent with Rule 204A–1 under the Advisers take positions, which is the responsibility of the Act. In addition, Rule 206(4)–7 under the Advisers (6) All of the equities and VIX Index Commodity Futures Trading Commission (‘‘CFTC’’). Act makes it unlawful for an investment adviser to Related Instruments will be listed on a provide investment advice to clients unless such U.S. exchange. The Fund will not enter The CFTC has the authority to set limits on the positions that any person may take in futures. These investment adviser has (i) adopted and into futures that are not traded on a U.S. implemented written policies and procedures limits may be directly set by the CFTC or by the reasonably designed to prevent violation, by the exchange. In addition, the Fund does markets on which the futures are traded. The investment adviser and its supervised persons, of not expect to invest in options or enter Commission has no role in establishing position the Advisers Act and the Commission rules adopted into swap agreements, including credit limits on futures even though such limits could thereunder; (ii) implemented, at a minimum, an default swaps, but may do so if such impact an exchange-traded product that is under annual review regarding the adequacy of the the jurisdiction of the Commission. policies and procedures established pursuant to 27 15 U.S.C. 78f(b)(5). subparagraph (i) above and the effectiveness of their administering the policies and procedures adopted implementation; and (iii) designated an individual under subparagraph (i) above. 28 15 U.S.C. 78s(b)(2). (who is a supervised person) responsible for 25 17 CFR 240.10A–3. 29 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s an incentive to engage in the Strategy COMMISSION Statement of the Purpose of, and the Executions. The Exchange has Statutory Basis for, the Proposed Rule determined that it does not wish to [Release No. 34–68157; File No. SR– Change continue to provide an incentive via its NYSEARCA–2012–119] 1. Purpose Fee Schedule to engage in dividend spread trading because this strategy may Self-Regulatory Organizations; NYSE The Exchange proposes to amend its encourage high volumes of trading of Fee Schedule to remove dividend Arca, Inc.; Notice of Filing and certain securities near the ex-dividend spreads from the list of strategy Immediate Effectiveness of a Proposed date and present operational risks to executions for which fee caps apply. market participants with respect to Rule Change To Amend the NYSE Arca The proposed fee change will be Options Fee Schedule To Remove clearing, exercise, and assignment or operative on November 1, 2012. other issues that may prevent the market Dividend Spreads From the List of Under the Exchange’s current Fee participant from the timely exercise of Strategy Executions for Which Fee Schedule, there is a $750 cap on call options and collecting the dividend Caps Apply transaction fees for strategy executions owed. As such, the Exchange proposes involving (a) reversals and conversions,4 November 5, 2012. to remove dividend spreads from the (b) dividend spreads,5 (c) box spreads,6 Pursuant to Section 19(b)(1) 1 of the (d) short stock interest spreads,7 (e) Strategy Executions fee caps. Securities Exchange Act of 1934 (the merger spreads,8 and (f) jelly rolls 9 The Exchange also proposes to specify ‘‘Act’’),2 and Rule 19b–4 thereunder,3 (‘‘Strategy Executions’’). The cap applies that, as a result of removing dividend notice is hereby given that on October to each Strategy Execution executed on spreads from the list of Strategy 23, 2012, NYSE Arca, Inc. (the the same trading day in the same option Executions that are subject to the fee ‘‘Exchange’’ or ‘‘NYSE Arca’’) filed with class. Transaction fees for Strategy caps, the type of execution that the the Securities and Exchange Executions are further capped at Exchange currently considers to be a Commission (the ‘‘Commission’’) the $25,000 per month per initiating firm. dividend spread 11 would no longer be proposed rule change as described in Manual Broker Dealer and Firm excluded from the $75,000 cap per Items I, II, and III below, which Items Proprietary Strategy trades that do not month on Firm Proprietary fees and have been prepared by the self- reach the $750 cap are billed at $0.25 Broker Dealer fees for transactions 10 regulatory organization. The per contract. cleared in the customer range for The Exchange proposes to remove 12 Commission is publishing this notice to manual (open outcry) executions. dividend spreads from the list of solicit comments on the proposed rule Currently, all Strategy Executions are Strategy Executions that are subject to change from interested persons. excluded from this cap, including the fee caps. The fee caps may provide dividend spreads. However, because I. Self-Regulatory Organization’s dividend spreads would no longer be Statement of the Terms of Substance of 4 A ‘‘reversal’’ is established by combining a short considered a Strategy Execution for security position with a short put and a long call the Proposed Rule Change position that shares the same strike and expiration. purposes of billing on the Exchange, the A ‘‘conversion’’ is established by combining a long cap would no longer exclude such The Exchange proposes to amend the position in the underlying security with a long put executions. However, the Exchange does NYSE Arca Options Fee Schedule (‘‘Fee and a short call position that shares the same strike not anticipate that this would result in Schedule’’) to remove dividend spreads and expiration. 5 A ‘‘dividend spread’’ is defined as transactions a significant amount of such executions from the list of strategy executions for done to achieve a dividend arbitrage involving the occurring on the Exchange. In this which fee caps apply. The text of the purchase, sale and exercise of in-the-money options regard, the Exchange believes that the proposed rule change is available on the of the same class, executed prior to the date on elimination of the $750 fee cap would Exchange’s Web site at www.nyse.com, which the underlying stock goes ex-dividend. eliminate the incentive for market 6 A ‘‘box spread’’ is defined as transactions at the principal office of the Exchange, involving a long call option and a short put option participants to effect such executions on and at the Commission’s Public at one strike, combined with a short call option and the Exchange. Reference Room. long put at a different strike, to create synthetic long and synthetic short stock positions, respectively. The proposed change is not otherwise II. Self-Regulatory Organization’s 7 A ‘‘short stock interest spread’’ is defined as intended to address any other matter, Statement of the Purpose of, and transactions done to achieve a short stock interest and the Exchange is not aware of any arbitrage involving the purchase, sale and exercise Statutory Basis for, the Proposed Rule significant problem that the affected of in-the-money options of the same class. market participants would have in Change 8 A ‘‘merger spread’’ is defined as transactions done to achieve a merger arbitrage involving the complying with the proposed change. In its filing with the Commission, the purchase, sale and exercise of options of the same 2. Statutory Basis self-regulatory organization included class and expiration date, each executed prior to the date on which shareholders of record are required statements concerning the purpose of to elect their respective form of consideration, i.e., The Exchange believes that the and basis for the proposed rule change cash or stock. proposed rule change is consistent with and discussed any comments it received 9 A ‘‘jelly roll’’ is created by entering into two Section 6(b) of the Securities Exchange separate positions simultaneously. One position on the proposed rule change. The text involves buying a put and selling a call with the of those statements may be examined at same strike price and expiration. The second 11 See supra note 5. the places specified in Item IV below. position involves selling a put and buying a call, 12 This resulting change would not require a The Exchange has prepared summaries, with the same strike price, but with a different corresponding change in the Fee Schedule and, expiration from the first position. accordingly, there is not a change proposed in this set forth in sections A, B, and C below, 10 All Royalty fees associated with Strategy respect in the Exhibit 5 attached hereto. In this of the most significant parts of such Executions on Index and Exchange Traded Funds regard, while Strategy Executions are referenced statements. are passed through to trading participants on the with respect to the $75,000 fee cap, the different Strategy Executions on a pro-rata basis. These types of Strategy Executions are not specifically Royalty fees are not included in the calculation of identified, as is done for the $750 fee cap. 1 15 U.S.C. 78s(b)(1). the $750 per trade cap or the $25,000 per month Nonetheless, the Exchange believes that describing 2 15 U.S.C. 78a. strategy fee cap. FLEX Option trades also are not the resulting treatment will specify the impact 3 17 CFR 240.19b–4. eligible for strategy treatment. regarding the $75,000 fee cap.

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Act of 1934 (the ‘‘Act’’),13 in general, adjusting, its fees and credits to remain All submissions should refer to File and furthers the objectives of Section competitive with other exchanges. For Number SR–NYSEARCA–2012–119. 6(b)(4) of the Act,14 in particular, the reasons described above, the This file number should be included on because it provides for the equitable Exchange believes that the proposed the subject line if email is used. To help allocation of reasonable dues, fees, and rule change reflects this competitive the Commission process and review other charges among its members, environment. your comments more efficiently, please issuers and other persons using its B. Self-Regulatory Organization’s use only one method. The Commission facilities and does not unfairly Statement on Burden on Competition will post all comments on the discriminate between customers, Commission’s Internet Web site (http:// issuers, brokers, or dealers. The Exchange does not believe that www.sec.gov/rules/sro.shtml). Copies of The Exchange believes that the the proposed rule change will impose proposed change is reasonable because any burden on competition that is not the submission, all subsequent the fee caps may provide an incentive necessary or appropriate in furtherance amendments, all written statements to engage in dividend spreads and the of the purposes of the Act. with respect to the proposed rule change that are filed with the Exchange has determined that it no C. Self-Regulatory Organization’s longer wishes to offer any potential Commission, and all written Statement on Comments on the communications relating to the incentive via its Fee Schedule in light Proposed Rule Change Received From proposed rule change between the of the operational risks that dividend Members, Participants, or Others spreads may present. The Exchange also Commission and any person, other than believes that the proposed change is No written comments were solicited those that may be withheld from the equitable and not unfairly or received with respect to the proposed public in accordance with the discriminatory because it would apply rule change. provisions of 5 U.S.C. 552, will be equally to all market participants and III. Date of Effectiveness of the available for Web site viewing and because the remaining Strategy Proposed Rule Change and Timing for printing in the Commission’s Public Executions that would continue to be Commission Action Reference Room, 100 F Street NE., subject to the fee caps do not present the The foregoing rule change is effective Washington, DC 20549–1090, on official same type of potential operational risks. business days between the hours of Furthermore, it is reasonable to upon filing pursuant to Section 16 10:00 a.m. and 3:00 p.m. Copies of the specify that the type of execution that 19(b)(3)(A) of the Act and 17 filing will also be available for the Exchange currently considers to be subparagraph (f)(2) of Rule 19b–4 a dividend spread 15 would no longer be thereunder, because it establishes a due, inspection and copying at the NYSE’s excluded from the $75,000 cap per fee, or other charge imposed by NYSE principal office and on its Internet Web month on Firm Proprietary fees and Arca. site at www.nyse.com. All comments Broker Dealer fees for transactions At any time within 60 days of the received will be posted without change; filing of such proposed rule change, the cleared in the customer range for the Commission does not edit personal Commission summarily may manual (open outcry) executions. identifying information from temporarily suspend such rule change if Specifically, because dividend spreads submissions. You should submit only it appears to the Commission that such would no longer be considered a information that you wish to make action is necessary or appropriate in the Strategy Execution for purposes of available publicly. All submissions public interest, for the protection of billing on the Exchange, the $75,000 fee should refer to File Number SR– investors, or otherwise in furtherance of cap would no longer exclude such NYSEARCA–2012–119 and should be the purposes of the Act. executions. However, the Exchange does submitted on or before November 30, not anticipate that this would result in IV. Solicitation of Comments 2012. a significant amount of such executions Interested persons are invited to For the Commission, by the Division of occurring on the Exchange. In this submit written data, views, and Trading and Markets, pursuant to delegated regard, the Exchange believes that the arguments concerning the foregoing, authority.18 elimination of the $750 fee cap would including whether the proposed rule Kevin M. O’Neill, eliminate the incentive for market change is consistent with the Act. Deputy Secretary. participants to effect such executions on Comments may be submitted by any of the Exchange. This would also be the following methods: [FR Doc. 2012–27363 Filed 11–8–12; 8:45 am] equitable and not unfairly BILLING CODE 8011–01–P discriminatory because it would not Electronic Comments differentiate between any particular • Use the Commission’s Internet market participants when determining comment form (http://www.sec.gov/ whether the $75,000 fee cap has been rules/sro.shtml); or reached with respect to the inclusion of • Send an email to rule- the type of execution that the Exchange [email protected]. Please include File currently considers to be a dividend Number SR–NYSEARCA–2012–119 on spread. the subject line. The Exchange notes that it operates in a highly competitive market in which Paper Comments market participants can readily favor • Send paper comments in triplicate competing venues. In such an to Elizabeth M. Murphy, Secretary, environment, the Exchange must Securities and Exchange Commission, continually review, and consider 100 F Street NE., Washington, DC 20549–1090. 13 15 U.S.C. 78f(b). 14 15 U.S.C. 78f(b)(4). 16 15 U.S.C. 78s(b)(3)(A). 15 See supra note 5. 17 17 CFR 240.19b–4(f)(2). 18 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE A. Self-Regulatory Organization’s Strategy Executions that are subject to COMMISSION Statement of the Purpose of, and the the fee caps. The fee caps may provide Statutory Basis for, the Proposed Rule an incentive to engage in the Strategy [Release No. 34–68156; File No. SR– Change Executions. The Exchange has determined that it does not wish to NYSEMKT–2012–57] 1. Purpose continue to provide an incentive via its Self-Regulatory Organizations; NYSE The Exchange proposes to amend its Fee Schedule to engage in dividend Fee Schedule to remove dividend MKT LLC; Notice of Filing and spread trading because this strategy may spreads from the list of strategy Immediate Effectiveness of a Proposed encourage high volumes of trading of executions for which fee caps apply. Rule Change To Amend the NYSE certain securities near the ex-dividend The proposed fee change will be date and present operational risks to Amex Options Fee Schedule To operative on November 1, 2012. Remove Dividend Spreads From the market participants with respect to Under the Exchange’s current Fee clearing, exercise, and assignment or List of Strategy Executions for Which Schedule, there is a $750 cap on other issues that may prevent the market Fee Caps Apply transaction fees for strategy executions participant from the timely exercise of involving (a) reversals and conversions,4 November 5, 2012. call options and collecting the dividend (b) dividend spreads,5 (c) box spreads,6 owed. As such, the Exchange proposes Pursuant to Section 19(b)(1) 1 of the (d) short stock interest spreads,7 (e) to remove dividend spreads from the Securities Exchange Act of 1934 (the merger spreads,8 and (f) jelly rolls9 Strategy Executions fee caps. ‘‘Act’’),2 and Rule 19b–4 thereunder,3 (‘‘Strategy Executions’’). The cap applies The Exchange also proposes to specify notice is hereby given that on October to each Strategy Execution executed on that, as a result of removing dividend 24, 2012, NYSE MKT LLC (the the same trading day in the same option spreads from the list of Strategy ‘‘Exchange’’ or ‘‘NYSE MKT’’) filed with class. Transaction fees for Strategy Executions that are subject to the fee the Securities and Exchange Executions are further capped at caps, the type of execution that the Commission (the ‘‘Commission’’) the $25,000 per month per initiating firm. Exchange currently considers to be a proposed rule change as described in Manual Broker Dealer and Firm dividend spread 11 would no longer be Items I, II, and III below, which Items Proprietary Strategy trades that do not excluded when determining whether have been prepared by the self- reach the $750 cap are billed at $0.25 certain other caps and thresholds that 10 regulatory organization. The per contract. exclude Strategy Executions have been The Exchange proposes to remove Commission is publishing this notice to satisfied, as described in the Fee dividend spreads from the list of solicit comments on the proposed rule Schedule. This would apply to (i) the change from interested persons. $350,000 cap and the volume threshold 4 A ‘‘reversal’’ is established by combining a short of 3,500,000 contracts described in security position with a short put and a long call I. Self-Regulatory Organization’s position that shares the same strike and expiration. endnote 5 in the Fee Schedule (ii) the Statement of the Terms of Substance of A ‘‘conversion’’ is established by combining a long $100,000 fee cap described in endnote the Proposed Rule Change position in the underlying security with a long put 6 of the Fee Schedule, (iii) the 75% and a short call position that shares the same strike volume threshold related to Market The Exchange proposes to amend the and expiration. 5 A ‘‘dividend spread’’ is defined as transactions Maker ATP fees, (iv) the 120,000 NYSE Amex Options Fee Schedule done to achieve a dividend arbitrage involving the average daily volume (‘‘ADV’’) (‘‘Fee Schedule’’) to remove dividend purchase, sale and exercise of in-the-money options threshold related to Customer Electronic spreads from the list of strategy of the same class, executed prior to the date on ADV Tiers, and (v) the 120,000 and executions for which fee caps apply. which the underlying stock goes ex-dividend. 6 A ‘‘box spread’’ is defined as transactions 200,000 volume thresholds described in The text of the proposed rule change is involving a long call option and a short put option endnote 17 of the Fee Schedule as well available on the Exchange’s Web site at at one strike, combined with a short call option and as the rebate referenced therein.12 www.nyse.com, at the principal office of long put at a different strike, to create synthetic long and synthetic short stock positions, respectively. Currently, all Strategy Executions, the Exchange, and at the Commission’s 7 A ‘‘short stock interest spread’’ is defined as including dividend spreads, are Public Reference Room. transactions done to achieve a short stock interest excluded from these fee caps and arbitrage involving the purchase, sale and exercise volume thresholds. However, because II. Self-Regulatory Organization’s of in-the–money options of the same class. dividend spreads would no longer be 8 A ‘‘merger spread’’ is defined as transactions Statement of the Purpose of, and considered a Strategy Execution for Statutory Basis for, the Proposed Rule done to achieve a merger arbitrage involving the purchase, sale and exercise of options of the same purposes of billing on the Exchange, the Change class and expiration date, each executed prior to the caps and thresholds would no longer date on which shareholders of record are required In its filing with the Commission, the to elect their respective form of consideration, i.e., exclude such executions. However, the self-regulatory organization included cash or stock. Exchange does not anticipate that this statements concerning the purpose of 9 A ‘‘jelly roll’’ is created by entering into two would result in a significant amount of separate positions simultaneously. One position and basis for the proposed rule change such executions occurring on the involves buying a put and selling a call with the Exchange. In this regard, the Exchange and discussed any comments it received same strike price and expiration. The second believes that the elimination of the $750 on the proposed rule change. The text position involves selling a put and buying a call, with the same strike price, but with a different fee cap would eliminate the incentive of those statements may be examined at expiration from the first position. for market participants to effect such the places specified in Item IV below. 10 All Royalty fees associated with Strategy executions on the Exchange. The Exchange has prepared summaries, Executions on Index and Exchange Traded Funds The proposed change is not otherwise set forth in sections A, B, and C below, are passed through to trading participants on the Strategy Executions on a pro-rata basis. These intended to address any other matter, of the most significant parts of such Royalty fees are not included in the calculation of and the Exchange is not aware of any statements. the $750 per trade cap or the $25,000 per month significant problem that the affected strategy fee cap. FLEX Option trades also are not eligible for strategy treatment. In addition, any 1 15 U.S.C. 78s(b)(1). qualifying Strategy Execution executed as a 11 See supra note 5. 2 15 U.S.C. 78a. Qualified Contingent Cross order is ineligible for 12 The Exchange proposes to remove references to 3 17 CFR 240.19b–4. the fee caps. dividend spreads from endnotes 5 and 6.

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market participants would have in execution that the Exchange currently Number SR–NYSEMKT–2012–57 on the complying with the proposed change.13 considers to be a dividend spread. subject line. The Exchange notes that it operates in 2. Statutory Basis a highly competitive market in which Paper Comments The Exchange believes that the market participants can readily favor • Send paper comments in triplicate proposed rule change is consistent with competing venues. In such an to Elizabeth M. Murphy, Secretary, Section 6(b) of the Securities Exchange environment, the Exchange must Securities and Exchange Commission, Act of 1934 (the ‘‘Act’’),14 in general, continually review, and consider 100 F Street NE., Washington, DC and furthers the objectives of Section adjusting, its fees and credits to remain 20549–1090. 6(b)(4) of the Act,15 in particular, competitive with other exchanges. For because it provides for the equitable the reasons described above, the All submissions should refer to File allocation of reasonable dues, fees, and Exchange believes that the proposed Number SR–NYSEMKT–2012–57. This other charges among its members, rule change reflects this competitive file number should be included on the issuers and other persons using its environment. subject line if email is used. To help the facilities and does not unfairly Commission process and review your B. Self-Regulatory Organization’s discriminate between customers, comments more efficiently, please use Statement on Burden on Competition issuers, brokers, or dealers. only one method. The Commission will The Exchange believes that the The Exchange does not believe that post all comments on the Commission’s proposed change is reasonable because the proposed rule change will impose Internet Web site (http://www.sec.gov/ the fee caps may provide an incentive any burden on competition that is not rules/sro.shtml ). Copies of the to engage in dividend spreads and the necessary or appropriate in furtherance submission, all subsequent Exchange has determined that it no of the purposes of the Act. amendments, all written statements longer wishes to offer any potential C. Self-Regulatory Organization’s with respect to the proposed rule incentive via its Fee Schedule in light Statement on Comments on the change that are filed with the of the operational risks that dividend Proposed Rule Change Received From Commission, and all written spreads may present. The Exchange also Members, Participants, or Others communications relating to the believes that the proposed change is equitable and not unfairly No written comments were solicited proposed rule change between the discriminatory because it would apply or received with respect to the proposed Commission and any person, other than equally to all market participants and rule change. those that may be withheld from the public in accordance with the because the remaining Strategy III. Date of Effectiveness of the Executions that would continue to be provisions of 5 U.S.C. 552, will be Proposed Rule Change and Timing for available for Web site viewing and subject to the fee caps do not present the Commission Action same type of potential operational risks. printing in the Commission’s Public Furthermore, it is reasonable to The foregoing rule change is effective Reference Room, 100 F Street NE., specify that the type of execution that upon filing pursuant to Section Washington, DC 20549–1090, on official the Exchange currently considers to be 19(b)(3)(A) 17 of the Act and business days between the hours of a dividend spread 16 would no longer be subparagraph (f)(2) of Rule 19b–4 18 10:00 a.m. and 3:00 p.m. Copies of the excluded from the fee caps and volume thereunder, because it establishes a due, filing will also be available for thresholds described in the Fee fee, or other charge imposed by the inspection and copying at the NYSE’s Schedule. Specifically, because NYSE MKT. principal office and on its Internet Web dividend spreads would no longer be At any time within 60 days of the site at www.nyse.com. All comments filing of such proposed rule change, the considered a Strategy Execution for received will be posted without change; Commission summarily may purposes of billing on the Exchange, the the Commission does not edit personal temporarily suspend such rule change if fee caps and volume thresholds would identifying information from it appears to the Commission that such no longer exclude such executions. submissions. You should submit only However, the Exchange does not action is necessary or appropriate in the public interest, for the protection of information that you wish to make anticipate that this would result in a available publicly. All submissions significant amount of such executions investors, or otherwise in furtherance of the purposes of the Act. should refer to File Number SR– occurring on the Exchange. In this NYSEMKT–2012–57 and should be regard, the Exchange believes that the IV. Solicitation of Comments submitted on or before November 30, elimination of the $750 fee cap would 2012. eliminate the incentive for market Interested persons are invited to participants to effect such executions on submit written data, views, and For the Commission, by the Division of the Exchange. This would also be arguments concerning the foregoing, Trading and Markets, pursuant to delegated equitable and not unfairly including whether the proposed rule authority.19 change is consistent with the Act. discriminatory because it would not Kevin M. O’Neill, differentiate between any particular Comments may be submitted by any of the following methods: Deputy Secretary. market participants when determining [FR Doc. 2012–27362 Filed 11–8–12; 8:45 am] whether the fee caps and volume Electronic Comments BILLING CODE 8011–01–P thresholds have been reached with • Use the Commission’s Internet respect to the inclusion of the type of comment form (http://www.sec.gov/ rules/sro.shtml ); or 13 The Exchange is proposing a minor non- • substantive change to the Fee Schedule to correct Send an email to rule- the grammar of the existing text therein. [email protected]. Please include File 14 15 U.S.C. 78f(b). 15 15 U.S.C. 78f(b)(4). 17 15 U.S.C. 78s(b)(3)(A). 16 See supra note 5. 18 17 CFR 240.19b–4(f)(2). 19 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE statements may be examined at the Holder) during the connectivity process COMMISSION places specified in Item IV below. The in accordance with technical Exchange has prepared summaries, set specifications established by the [Release No. 34–68155; File No. SR–CBOE– Exchange. The Exchange may prescribe 2012–100] forth in sections A, B, and C below, of the most significant aspects of such a specific connectivity protocol for all Self-Regulatory Organizations; statements. Trading Permit Holders, or for certain Chicago Board Options Exchange, categories of similarly situated Trading A. Self-Regulatory Organization’s Permit Holders (e.g. Floor Brokers, Incorporated; Notice of Filing and Statement of the Purpose of, and Immediate Effectiveness of a Proposed Designated Primary Market-Makers Statutory Basis for, the Proposed Rule (‘‘DPMs’’), or Market-Makers). Rule Change Relating to System Change Access, Connectivity, and Testing It is imperative for the Exchange to 1. Purpose receive during the connectivity process November 5, 2012. information regarding a Trading Permit Pursuant to Section 19(b)(1) of the The Exchange proposes to amend its Holder’s identification so that the Securities Exchange Act of 1934 (the rules regarding System access, Exchange can ensure that the ‘‘Act’’),1 and Rule 19b–4 thereunder,2 connectivity, and testing by Trading connecting party is a Trading Permit notice is hereby given that on October Permit Holders. The Exchange makes Holder authorized to access the System 23, 2012, Chicago Board Options available to Trading Permit Holders and that the Exchange is aware of what various application programming type of Trading Permit Holder the Exchange, Incorporated (the ‘‘Exchange’’ 4 or ‘‘CBOE’’) filed with the Securities interfaces (‘‘APIs’’), such as CBOE connecting party is. Requiring a specific and Exchange Commission (the Market Interface (‘‘CMi’’) and Financial connectivity protocol allows the ‘‘Commission’’) the proposed rule Information eXchange (‘‘FIX’’) Protocol, Exchange to receive this information in for authorized Trading Permit Holders a uniform manner for all Trading Permit change as described in Items I, II, and 5 III below, which Items have been to use to access the System. Trading Holders, or categories of similarly prepared by the Exchange. The Permit Holders may select which of situated Trading Permit Holders, as the Commission is publishing this notice to these APIs they would like to use to Exchange deems necessary. This solicit comments on the proposed rule connect to the System when registering information allows the Exchange to, change from interested persons. with the Exchange for System access. among other things, perform the The Exchange believes it is important to necessary surveillances applicable to I. Self-Regulatory Organization’s provide Trading Permit Holders with the Trading Permit Holder and Statement of the Terms of the Substance this flexibility so that they can determine whether the Trading Permit of the Proposed Rule Change determine the API that will be most Holder is complying with all relevant The Exchange proposes to amend its compatible with their systems and Exchange Rules. Many of the Exchange’s rules regarding Hybrid Trading System maximize the efficiency of their surveillances are conducted by type of (the ‘‘System’’) 3 access, connectivity, systems’ connection to the System. Trading Permit Holders, as different and testing by Trading Permit Holders. Connection to the System allows types have different responsibilities The text of the proposed rule change is authorized Trading Permit Holders to they must meet under the Exchange available on the Exchange’s Web site enter and execute orders, as well as rules.6 The Exchange believes that (http://www.cboe.com/AboutCBOE/ submit certain order and trade data to receiving trade data in an organized and CBOELegalRegulatoryHome.aspx), at the Exchange, which data the Exchange uniform format from all Trading Permit the Exchange’s Office of the Secretary, uses to conduct surveillances of its Holders, or types of Trading Permit and at the Commission. markets and Trading Permit Holders. Holders, allows it to efficiently identify After a Trading Permit Holder Trading Permit Holders and monitor II. Self-Regulatory Organization’s registers with the Exchange to use a and conduct surveillances of its markets Statement of the Purpose of, and specific API, the Exchange may require and Trading Permit Holder, and thus Statutory Basis for, the Proposed Rule the Trading Permit Holder to use a effectively fulfill its regulatory Change specific connectivity protocol that, responsibilities. Additionally, the In its filing with the Commission, the among other things, may require the Exchange believes that prescribing Exchange included statements input of certain information (e.g. trading connectivity protocols on either all concerning the purpose of and basis for acronym, category of Trading Permit Trading Permit Holders or categories of the proposed rule change and discussed similarly situated Trading Permit any comments it received on the 4 APIs are computer programs that allow Trading Holders ensures that the Exchange proposed rule change. The text of these Permit Holders to interface with the Exchange. makes these prescriptions in an 5 Only Trading Permit Holders may access the System. The Commission adopted Rule 15c3–5 objective manner. 1 15 U.S.C. 78s(b)(1). under the Act, which, among other things, requires The Exchange also periodically 2 17 CFR 240.19b–4. broker-dealers providing others with access to an requires Trading Permit Holders that 3 The System is a trading platform that allows exchange or alternative trading system to establish, have been authorized to access the automatic executions to occur electronically and document, and maintain a system of risk open outcry trades to occur on the floor of the management controls and supervisory procedures System to conduct or participate in the Exchange. To operate in this ‘‘hybrid’’ environment, reasonably designed to manage the financial, testing of their computer systems to the Exchange has a dynamic order handling system regulatory, and other risks of providing such access. ascertain the compatibility of these that has the capability to route orders to the trade See Securities Exchange Act Release No. 63241 systems with the System. The Exchange engine for automatic execution and book entry, to (November 3, 2010), 75 FR 69792 (November 15, Trading Permit Holder and PAR Official 2010). Rule 15c3–5 effectively eliminated ‘‘naked believes that it is critical that Trading workstations located in the trading crowds for access’’ (i.e. ‘‘Sponsored Users’’) to the Exchange by manual handling, and/or to other order non-Trading Permit Holders and effectively requires 6 For example, a DPM must satisfy quoting management terminals generally located in booths Trading Permit Holders to filter all non-Trading obligations that are different than those that a on the trading floor for manual handling. Where an Permit Holder orders prior to being sent to the Market-Maker must satisfy, and the Exchange order is routed for processing by the Exchange order Exchange. The Exchange expects to eliminate the reviews their quoting activity to determine whether handling system depends on various parameters concept of Sponsored Users under its Rules in they have satisfied their respective obligations. See configured by the Exchange and the order entry connection with the adoption of Rule 15c3–5 in a Rule 8.85 (obligations of DPMs) and Rule 8.7 firm itself. separate rule filing. (obligations of Market-Makers).

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Permit Holders work closely with the Regulatory Circular any connectivity believes that violations of the proposed Exchange in testing new software protocol prescription. mandatory system testing provision are releases and other System changes. Proposed Rule 6.23A(e)(i) provides suitable for its minor rule violation plan System testing allows the Exchange to that each Trading Permit Holder that the because they are generally technical in ensure that Trading Permit Holders’ Exchange designates as required to nature. Further, including these systems are continuously compatible participate in a system test must violations into the minor rule violation with the System in the event of System conduct or participate in the testing of plan will allow the Exchange to carry changes and that the Exchange its computer systems to ascertain the out its regulatory responsibilities more continues to receive all necessary data compatibility of such systems with the quickly and efficiently. System in the manner and frequency from Trading Permit Holders in a timely The proposed rule change also manner and efficient format. prescribed by the Exchange. The Exchange will designate Trading Permit amends Rule 50.2(a) in the CBOE Stock Additionally, System testing allows Exchange, LLC (‘‘CBSX’’) 9 Rules to Trading Permit Holders to make any Holders as required to participate in a system test based on: (1) The category of clarify that references to ‘‘Hybrid necessary adjustments to their systems Trading System,’’ ‘‘Hybrid System,’’ and in the event of System changes to ensure the Trading Permit Holder (e.g. Floor ‘‘System’’ in Exchange Rules that are that their connections to the System are Broker, DPM, Market-Maker); (2) the applicable to trading on CBSX should be functioning properly and that they are computer system(s) the Trading Permit read to mean ‘‘CBSX System.’’ able to submit order and trade Holder uses; and (3) the manner in Additionally, the proposed rule change information in compliance with all which the Trading Permit Holder amends Appendix A to the CBSX Rules applicable Exchange Rules. connects to the System. The Exchange to provide that Rule 6.23A(c) through (e) The Exchange proposes to codify will give Trading Permit Holders reasonable notice of any mandatory applies to the trading of equity these current Exchange practices and securities on CBSX. This change requirements related to System access systems test, which notice will specify the nature of the test and Trading Permit clarifies that the Exchange may and connectivity. Proposed Rule similarly require CBSX Trading Permit 6.23A(c) clarifies in the Rules that only Holders’ obligations in participation in the test. Holders, or categories of CBSX Trading Trading Permit Holders (and their Permit Holders (e.g. Remote Market- associated persons) may be authorized In connection with this mandatory system testing, proposed Rule Makers), to connect to the Exchange in to access the System to enter and 6.23A(e)(ii) provides that every Trading accordance with a specific connectivity execute orders. This proposed provision Permit Holder required by the Exchange protocol and to participate in system also provides that the Exchange will to conduct or participate in testing of testing as the Exchange deems require a Trading Permit Holder to enter computer systems must provide to the necessary. into a software user or license Exchange any reports relating to the agreement with the Exchange in a form Codification of these requirements testing as the Exchange may prescribe. or forms prescribed by the Exchange in gives the Exchange the ability to Trading Permit Holders must maintain order to obtain authorized access to the discipline any Trading Permit Holders adequate documentation of tests System if the Trading Permit Holder that fail to comply with these required by this Rule and results of this requirements. While Trading Permit elects to use an API for which the testing for examination by the Exchange. Exchange has determined that this type Holders generally comply with these Proposed Rule 6.23A(e)(iii) states that requirements, their inclusion in the of an agreement is necessary. In other a Trading Permit Holder that fails to words, whether the Exchange requires a Rules (and the resulting potential for conduct or participate in mandatory discipline for noncompliance) may Trading Permit Holder to enter into a systems tests, fails to file the required user or license agreement will depend enhance Trading Permit Holders’ overall reports, or fails to maintain the required compliance with them. solely on the objective criteria of what documentation, as required by proposed type of API the Trading Permit Holder Rule 6.23A(e)(i) and (ii), may be subject Codification of these requirements is opts to use.7 The proposed rule change to summary suspension or other action also consistent with the Rules of other also amends Rule 6.23A(a) to clarify that taken pursuant to Chapter XVI exchanges. Proposed Rule 6.23A(c) is the term API means application (Summary Suspension) and/or substantially similar to: BATS programming interface. disciplinary action pursuant to Chapter Exchange, Inc. (‘‘BATS’’) Rule 11.3(a); Proposed Rule 6.23A(d) provides that XVII (Discipline) of the Exchange Rules. BOX Options Exchange LLC (‘‘BOX’’) the Exchange may prescribe technical Disciplinary action may include fines Rule 7000(a); EDGA Exchange, Inc. specifications pursuant to which all pursuant to proposed Rule 17.50(g)(19), (‘‘EDGA’’) Chapter XI, Rule 11.3(a); Trading Permit Holders, or categories of which provides that Trading Permit EDGX Exchange, Inc. (‘‘EDGX’’) Chapter similarly situated Trading Permit Holders that violate proposed Rule XI, Rule 11.3(a); International Securities Holders (e.g., Floor Brokers, DPMs, 6.23A(e) may be subject to fines under Exchange, LLC (‘‘ISE’’) Rule 706(a); Market-Makers), may establish an the Exchange’s minor rule violation NASDAQ Option Market (‘‘NOM’’) electronic connection to the System and plan.8 As with all other violations in the Chapter V, Section 1(a); NYSE Arca, Inc. its facilities. The Exchange will Exchange’s minor rule violation plan, (‘‘NYSE Arca’’) Rule 6.2A(a); and NYSE announce to Trading Permit Holders via the Exchange retains the ability to refer MKT LLC (‘‘NYSE MKT’’) Rule a violation of the system testing 902.1NY(a). Proposed Rule 6.23A(e) is 7 For example, the Exchange developed CMi and requirements to its Business Conduct substantially similar to: BATS Rule currently requires all Trading Permit Holders that Committee should the circumstances 18.13; BOX Rule 3180; ISE Rule 419; opt to connect to the System using CMi to enter into and NOM Chapter III, Section 13. BOX a software license agreement with the Exchange to warrant such a referral. The Exchange use CMi. The Exchange has determined that Rule 12140(d)(7) and ISE Rule Trading Permit Holders that opt to connect to the 8 These fines are as follows: $250 for the first 1614(d)(8) also allow those exchanges to System using FIX do not currently have to enter offense, $500 for the second offense, $1,000 for the fine their members for violations of their into any type of software user or license agreement, third offense, $2,000 for the fourth offense, and respective mandatory system provisions which is a universally available application for referral to the Business Conduct Committee for any which the developer does not require a user subsequent offenses. The fines are based on the agreement. number of offenses in one calendar year. 9 CBSX is a stock trading facility of the Exchange.

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pursuant to their respective minor rule Exchange believes that proposed Rule Holders as those rules do on those violation plans.10 6.23A(d) allows the Exchange to receive exchanges’ members. Additionally, proposed Rule 6.23A(c) from Trading Permit Holders, or B. Self-Regulatory Organization’s is consistent with Rule 15c3–1 [sic] categories of similarly situated Trading Statement on Burden on Competition under the Act.11 Permit Holders, information in a CBOE does not believe that the 2. Statutory Basis uniform format, which aids the Exchange’s efforts to monitor and proposed rule change will impose any The Exchange believes the proposed regulate CBOE’s markets and Trading burden on competition that is not rule change is consistent with the Act Permit Holders and helps prevent necessary or appropriate in furtherance and the rules and regulations fraudulent and manipulative practices. of the purposes of the Act. thereunder applicable to the Exchange This also helps coordinate the ability of C. Self-Regulatory Organization’s and, in particular, the requirements of Trading Permit Holders to electronically 12 Statement on Comments on the Section 6(b) of the Act. Specifically, trade on the Exchange with the Proposed Rule Change Received From the Exchange believes the proposed rule Exchange’s ability to receive the Members, Participants, or Others change is consistent with the Section necessary information to regulate those 6(b)(5) requirements that the rules of an transactions. Proposed Rule 6.23A(e) The Exchange neither solicited nor exchange be designed to promote just allows the Exchange to ensure that received comments on the proposed and equitable principles of trade, to Trading Permit Holders’ connections to rule change. prevent fraudulent and manipulative the System function correctly, which III. Date of Effectiveness of the acts, to foster cooperation and promotes efficiency and enhances Proposed Rule Change and Timing for coordination with persons engaged in compliance by Trading Permit Holders Commission Action regulating, clearing, settling, processing with Exchange Rules. The proposed information with respect to, and changes to the CBSX Rules clarify for Because the foregoing proposed rule facilitating transactions in securities, to CBSX Trading Permit Holders that they change does not: remove impediments to and to perfect are subject to and must comply with the A. Significantly affect the protection the mechanism for a free and open requirements in proposed Rule 6.23A. of investors or the public interest; market and a national market system, In addition, codification of these B. impose any significant burden on and, in general, to protect investors and requirements is consistent with the Act competition; and the public interest.13 Additionally, the because it gives the Exchange the ability C. become operative for 30 days from Exchange believes the proposed rule to discipline Trading Permit Holders the date on which it was filed, or such change is consistent with the Section that fail to comply with these shorter time as the Commission may 6(b)(5) requirement that the rules of a requirements, which may enhance designate, it has become effective national securities exchange be overall Trading Permit Holder pursuant to Section 19(b)(3)(A) 16 of the designed to not permit unfair compliance with these requirements. Act and Rule 19b–4(f)(6) 17 thereunder. discrimination between customer, This proposed rule change will also At any time within 60 days of the issuers, brokers or dealers.14 The promote consistency in the minor rule filing of this proposed rule change, the Exchange also believes the proposed violation programs of other exchanges Commission summarily may rule change is consistent with the and allow the Exchange to carry out its temporarily suspend such rule change if 15 Section 6(b)(6) requirement that the regulatory responsibilities more quickly it appears to the Commission that such rules of an exchange provide that its and efficiently by including violations action is necessary or appropriate in the members and persons associated with of the mandatory system testing public interest, for the protection of its members be appropriately provision in the Exchange’s minor rule investors, or otherwise in furtherance of disciplined for violation of the violation plan. the purposes of the Act. provisions of the Act, the rules and The Exchange believes that the regulations thereunder, or the rules of proposed rule change is designed to not IV. Solicitation of Comments the exchange, by expulsion, suspension, permit unfair discrimination among Interested persons are invited to limitation of activities, functions, and Trading Permit Holders, as the proposed submit written data, views, and operations, fine, censure, being rule change provides for the Exchange arguments concerning the foregoing, suspended or barred from being to impose requirements on Trading including whether the proposed rule associated with a member, or any other Permit Holders in an objective manner. change is consistent with the Act. fitting sanction. For example, under proposed Rule Comments may be submitted by any of The proposed rule change codifies 6.23A(d), the Exchange may impose the following methods: current Exchange requirements that connectivity protocol requirements on enhance CBOE’s market surveillances all Trading Permit Holders, or similarly Electronic Comments and System functionality. Proposed situated Trading Permit Holders. • Use the Commission’s Internet Rule 6.23A(c) is consistent with Rule Additionally, under proposed Rule comment form (http://www.sec.gov/ 15c3–5 under the Act, and the Exchange 6.23A(c), whether the Exchange requires rules/sro.shtml); or believes the proposed rule change a Trading Permit Holder to enter into a • Send an email to rule- promotes compliance by Trading Permit software user or license agreement [email protected]. Please include File Holders with the market access depends solely on what type of API the Number SR–CBOE–2012–100 on the requirements under that rule. The Trading Permit Holder opts to use to subject line. connect to the System. 10 The proposed fine amounts in proposed Rule Finally, the proposed rule change will Paper Comments 17.50(g)(19) are the same as the fine amounts in the help remove impediments to and • corresponding BOX and ISE rules. Send paper comments in triplicate 11 See supra note 5. promote a free and open market and a to Elizabeth M. Murphy, Secretary, 12 15 U.S.C. 78f(b). national market system because it is Securities and Exchange Commission, 13 15 U.S.C. 78f(b)(5). consistent with rules in place at other 14 Id. exchanges and imposes substantially 16 15 U.S.C. 78s(b)(3)(A). 15 15 U.S.C. 78f(b)(6). similar requirements on Trading Permit 17 17 CFR 240.19b–4(f)(6).

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100 F Street NE., Washington, DC notice is hereby given that on October select which of these APIs they would 20549–1090. 23, 2012, C2 Options Exchange, like to use to connect to the System All submissions should refer to File Incorporated (the ‘‘Exchange’’ or ‘‘C2’’) when registering with the Exchange for Number SR–CBOE–2012–100. This file filed with the Securities and Exchange System access. The Exchange believes it number should be included on the Commission (the ‘‘Commission’’) the is important to provide Participants subject line if email is used. To help the proposed rule change as described in with this flexibility so that they can Commission process and review your Items I, II, and III below, which Items determine the API that will be most comments more efficiently, please use have been prepared by the Exchange. compatible with their systems and only one method. The Commission will The Commission is publishing this maximize the efficiency of their post all comments on the Commission’s notice to solicit comments on the systems’ connection to the System. Internet Web site (http://www.sec.gov/ proposed rule change from interested Connection to the System allows rules/sro.shtml). Copies of the persons. authorized Participants to enter and submission, all subsequent execute orders, as well as submit certain I. Self-Regulatory Organization’s amendments, all written statements order and trade data to the Exchange, Statement of the Terms of the Substance with respect to the proposed rule which data the Exchange uses to of the Proposed Rule Change change that are filed with the conduct surveillances of its markets and Commission, and all written The Exchange proposes to amend its Participants. communications relating to the rules regarding System 3 access, After a Participant registers with the proposed rule change between the connectivity, and testing by Exchange to use a specific API, the Commission and any person, other than Participants. The text of the proposed Exchange may require the Participant to those that may be withheld from the rule change is available on the use a specific connectivity protocol that, public in accordance with the Exchange’s Web site (http:// among other things, may require the provisions of 5 U.S.C. 552, will be www.c2exchange.com/Legal/), at the input of certain information (e.g. trading available for Web site viewing and Exchange’s Office of the Secretary, and acronym, category of Participant) during printing in the Commission’s Public at the Commission. the connectivity process in accordance Reference Room on official business II. Self-Regulatory Organization’s with technical specifications established days between the hours of 10:00 a.m. Statement of the Purpose of, and by the Exchange. The Exchange may and 3:00 p.m. Copies of such filing also Statutory Basis for, the Proposed Rule prescribe a specific connectivity will be available for inspection and Change protocol for all Participants, or for copying at the principal offices of the certain categories of similarly situated Exchange. All comments received will In its filing with the Commission, the Participants (e.g. Market-Makers, be posted without change; the Exchange included statements Designated Primary Market-Makers Commission does not edit personal concerning the purpose of and basis for (‘‘DPMs’’)). identifying information from the proposed rule change and discussed It is imperative for the Exchange to submissions. You should submit only any comments it received on the receive during the connectivity process information that you wish to make proposed rule change. The text of these information regarding a Participant’s available publicly. All submissions statements may be examined at the identification so that the Exchange can should refer to File Number SR–CBOE– places specified in Item IV below. The ensure that the connecting party is a 2012–100, and should be submitted on Exchange has prepared summaries, set Participant authorized to access the or before November 30, 2012. forth in sections A, B, and C below, of System and that the Exchange is aware For the Commission, by the Division of the most significant aspects of such of what type of Participant the Trading and Markets, pursuant to delegated statements. connecting party is. Requiring a specific authority.18 A. Self-Regulatory Organization’s connectivity protocol allows the Kevin M. O’Neill, Statement of the Purpose of, and Exchange to receive this information in Deputy Secretary. Statutory Basis for, the Proposed Rule a uniform manner for all Participants, or [FR Doc. 2012–27361 Filed 11–8–12; 8:45 am] Change categories of similarly situated BILLING CODE 8011–01–P Participants, as the Exchange deems 1. Purpose necessary. This information allows the The Exchange proposes to amend its Exchange to, among other things, SECURITIES AND EXCHANGE rules regarding System access, perform the necessary surveillances COMMISSION connectivity, and testing by applicable to the Participant and Participants. The Exchange makes determine whether the Participant is [Release No. 34–68154; File No. SR–C2– 2012–036] available to Participants various complying with all relevant Exchange application programming interfaces Rules. Many of the Exchange’s Self-Regulatory Organizations; C2 (‘‘APIs’’),4 such as CBOE Market surveillances are conducted by type of Options Exchange, Incorporated; Interface (‘‘CMi’’) and Financial Participants, as different types have Notice of Filing and Immediate Information eXchange (‘‘FIX’’) Protocol, Effectiveness of a Proposed Rule for authorized Participants to use to and maintain a system of risk management controls Change Relating to System Access, access the System.5 Participants may and supervisory procedures reasonably designed to manage the financial, regulatory, and other risks of Connectivity, and Testing providing such access. See Securities Exchange Act 3 The System means the automated trading Release No. 63241 (November 3, 2010), 75 FR 69792 November 5, 2012. system used by the Exchange for the trading of (November 15, 2010). Rule 15c3–5 effectively Pursuant to Section 19(b)(1) of the options products. eliminated ‘‘naked access’’ (i.e. ‘‘Sponsored Users’’) Securities Exchange Act of 1934 (the 4 APIs are computer programs that allow to the Exchange by non-Participants and effectively ‘‘Act’’),1 and Rule 19b–4 thereunder,2 Participants to interface with the Exchange. requires Participants to filter all non-Participant 5 Only Participants may access the System. The orders prior to being sent to the Exchange. The Commission adopted Rule 15c3–5 under the Act, Exchange expects to eliminate the concept of 18 17 CFR 200.30–3(a)(12). which, among other things, requires broker-dealers sponsored use under its Rules in connection with 1 15 U.S.C. 78s(b)(1). providing others with access to an exchange or the adoption of Rule 15c3–5 in a separate rule 2 17 CFR 240.19b–4. alternative trading system to establish, document, filing.

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different responsibilities they must meet agreement will depend solely on the pursuant to Chapter 17 (Discipline) of under the Exchange rules.6 The objective criteria of what type of API the the Exchange Rules. Disciplinary action Exchange believes that receiving trade Participant opts to use.7 The proposed may include fines pursuant to proposed data in an organized and uniform format rule change also amends Rule 6.34(a) to Rule 17.50(g)(19), which provides that from all Participants, or types of clarify that the term API means Participants that violate proposed Rule Participants, allows it to efficiently application programming interface. 6.34(e) may be subject to fines under the identify Participants and monitor and Proposed Rule 6.34(d) provides that Exchange’s minor rule violation plan.8 conduct surveillances of its markets and the Exchange may prescribe technical As with all other violations in the Participant, and thus effectively fulfill specifications pursuant to which all Exchange’s minor rule violation plan, its regulatory responsibilities. Participants, or categories of similarly the Exchange retains the ability to refer Additionally, the Exchange believes that situated Participants (e.g., DPMs, a violation of the system testing prescribing connectivity protocols on Market-Makers), may establish an requirements to its Business Conduct either all Participants or categories of electronic connection to the System Committee should the circumstances (and any facilities). The Exchange will similarly situated Participants ensures warrant such a referral. The Exchange announce to Participants via Regulatory that the Exchange makes these believes that violations of the proposed Circular any connectivity protocol prescriptions in an objective manner. mandatory system testing provision are The Exchange also periodically prescription. requires Participants that have been Proposed Rule 6.34(e)(i) provides that suitable for its minor rule violation plan authorized to access the System to each Participant that the Exchange because they are generally technical in conduct or participate in the testing of designates as required to participate in nature. Further, including these their computer systems to ascertain the a system test must conduct or violations into the minor rule violation compatibility of these systems with the participate in the testing of its computer plan will allow the Exchange to carry System. The Exchange believes that it is systems to ascertain the compatibility of out its regulatory responsibilities more critical that Participants work closely such systems with the System in the quickly and efficiently. with the Exchange in testing new manner and frequency prescribed by the Codification of these requirements software releases and other System Exchange. The Exchange will designate gives the Exchange the ability to changes. System testing allows the Participants as required to participate in discipline any Participants that fail to Exchange to ensure that Participants’ a system test based on: (1) The category comply with these requirements. While systems are continuously compatible of the Participant (e.g. DPM, Market- Participants generally comply with with the System in the event of System Maker); (2) the computer system(s) the these requirements, their inclusion in changes and that the Exchange Participant uses; and (3) the manner in the Rules (and the resulting potential for continues to receive all necessary data which the Participant connects to the discipline for noncompliance) may from Participants in a timely manner System. The Exchange will give enhance Participants’ overall and efficient format. Additionally, Participants reasonable notice of any compliance with them. System testing allows Participants to mandatory systems test, which notice make any necessary adjustments to their will specify the nature of the test and Codification of these requirements is systems in the event of System changes Participants’ obligations in participation also consistent with the Rules of other to ensure that their connections to the in the test. exchanges. Proposed Rule 6.34(c) is System are functioning properly and In connection with this mandatory substantially similar to: BATS that they are able to submit order and system testing, proposed Rule 6.34(e)(ii) Exchange, Inc. (‘‘BATS’’) Rule 11.3(a); trade information in compliance with provides that every Participant required BOX Options Exchange LLC (‘‘BOX’’) all applicable Exchange Rules. by the Exchange to conduct or Rule 7000(a); EDGA Exchange, Inc. The Exchange proposes to codify participate in testing of computer (‘‘EDGA’’) Chapter XI, Rule 11.3(a); these current Exchange practices and systems must provide to the Exchange EDGX Exchange, Inc. (‘‘EDGX’’) Chapter requirements related to System access any reports relating to the testing as the XI, Rule 11.3(a); International Securities and connectivity. Proposed Rule 6.34(c) Exchange may prescribe. Participants Exchange, LLC (‘‘ISE’’) Rule 706(a); clarifies in the Rules that only must maintain adequate documentation NASDAQ Option Market (‘‘NOM’’) Participants (and their associated of tests required by this Rule and results Chapter V, Section 1(a); NYSE Arca, Inc. persons) may be authorized to access of this testing for examination by the (‘‘NYSE Arca’’) Rule 6.2A(a); and NYSE the System to enter and execute orders. Exchange. MKT LLC (‘‘NYSE MKT’’) Rule This proposed provision also provides Proposed Rule 6.34(e)(iii) states that a 902.1NY(a). Proposed Rule 6.34(e) is that the Exchange will require a Participant that fails to conduct or substantially similar to: BATS Rule Participant to enter into a software user participate in mandatory systems tests, 18.13; BOX Rule 3180; ISE Rule 419; or license agreement with the Exchange fails to file the required reports, or fails and NOM Chapter III, Section 13. BOX in a form or forms prescribed by the to maintain the required documentation, Rule 12140(d)(7) and ISE Rule Exchange in order to obtain authorized as required by proposed Rule 6.34(e)(i) 1614(d)(8) also allow those exchanges to access to the System if the Participant and (ii), may be subject to summary fine their members for violations of their elects to use an API for which the suspension or other action taken respective mandatory system provisions Exchange has determined that this type pursuant to Chapter 16 (Summary pursuant to their respective minor rule Suspension) and/or disciplinary action of an agreement is necessary. In other violation plans.9 words, whether the Exchange requires a 7 For example, the Exchange developed CMi and Participant to enter into a user or license 8 currently requires all Participants that opt to These fines are as follows: $250 for the first connect to the System using CMi to enter into a offense, $500 for the second offense, $1,000 for the 6 For example, a DPM must satisfy quoting software license agreement with the Exchange to third offense, $2,000 for the fourth offense, and obligations that are different than those that a use CMi. The Exchange has determined that referral to the Business Conduct Committee for any Market-Maker must satisfy, and the Exchange Participants that opt to connect to the System using subsequent offenses. The fines are based on the reviews their quoting activity to determine whether FIX do not currently have to enter into any type of number of offenses in one calendar year. they have satisfied their respective obligations. See software user or license agreement, which is a 9 The proposed fine amounts in proposed Rule Rule 8.17 (obligations of DPMs) and Rule 8.5 universally available application for which the 17.50(g)(19) are the same as the fine amounts in the (obligations of Market-Makers). developer does not require a user agreement. corresponding BOX and ISE rules.

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Additionally, proposed Rule 6.34(c) is format, which aids the Exchange’s C. Self-Regulatory Organization’s consistent with Rule 15c3–1 [sic] under efforts to monitor and regulate C2’s Statement on Comments on the the Act.10 markets and Participants and helps Proposed Rule Change Received From Members, Participants, or Others 2. Statutory Basis prevent fraudulent and manipulative practices. This also helps coordinate the The Exchange neither solicited nor The Exchange believes the proposed ability of Participants to electronically rule change is consistent with the Act received comments on the proposed trade on the Exchange with the rule change. and the rules and regulations Exchange’s ability to receive the thereunder applicable to the Exchange necessary information to regulate those III. Date of Effectiveness of the and, in particular, the requirements of transactions. Proposed Rule 6.34(e) Proposed Rule Change and Timing for Section 6(b) of the Act.11 Specifically, allows the Exchange to ensure that Commission Action the Exchange believes the proposed rule Participants’ connections to the System Because the foregoing proposed rule change is consistent with the Section function correctly, which promotes change does not: 6(b)(5) requirements that the rules of an efficiency and enhances compliance by A. Significantly affect the protection exchange be designed to promote just Participants with Exchange Rules. of investors or the public interest; and equitable principles of trade, to B. impose any significant burden on prevent fraudulent and manipulative In addition, codification of these competition; and acts, to foster cooperation and requirements is consistent with the Act C. become operative for 30 days from coordination with persons engaged in because it gives the Exchange the ability the date on which it was filed, or such regulating, clearing, settling, processing to discipline Participants that fail to shorter time as the Commission may information with respect to, and comply with these requirements, which designate, it has become effective facilitating transactions in securities, to may enhance overall Participants pursuant to Section 19(b)(3)(A) 15 of the remove impediments to and to perfect compliance with these requirements. Act and Rule 19b–4(f)(6) 16 thereunder. the mechanism for a free and open This proposed rule change will also At any time within 60 days of the market and a national market system, promote consistency in the minor rule filing of this proposed rule change, the and, in general, to protect investors and violation programs of other exchanges Commission summarily may the public interest.12 Additionally, the and allow the Exchange to carry out its temporarily suspend such rule change if Exchange believes the proposed rule regulatory responsibilities more quickly it appears to the Commission that such change is consistent with the Section and efficiently by including violations action is necessary or appropriate in the 6(b)(5) requirement that the rules of a of the mandatory system testing public interest, for the protection of national securities exchange be provision in the Exchange’s minor rule investors, or otherwise in furtherance of designed to not permit unfair violation plan. the purposes of the Act. discrimination between customer, The Exchange believes that the issuers, brokers or dealers.13 The IV. Solicitation of Comments proposed rule change is designed to not Exchange also believes the proposed Interested persons are invited to permit unfair discrimination among rule change is consistent with the submit written data, views, and Participants, as the proposed rule Section 6(b)(6) 14 requirement that the arguments concerning the foregoing, change provides for the Exchange to rules of an exchange provide that its including whether the proposed rule impose requirements on Participants in members and persons associated with change is consistent with the Act. an objective manner. For example, its members be appropriately Comments may be submitted by any of disciplined for violation of the under proposed Rule 6.34(d), the the following methods: provisions of the Act, the rules and Exchange may impose connectivity Electronic Comments regulations thereunder, or the rules of protocol requirements on all the exchange, by expulsion, suspension, Participants, or similarly situated • Use the Commission’s Internet limitation of activities, functions, and Participants. Additionally, under comment form (http://www.sec.gov/ operations, fine, censure, being proposed Rule 6.34(c), whether the rules/sro.shtml); or suspended or barred from being Exchange requires a Participant to enter • Send an email to rule- associated with a member, or any other into a software user or license [email protected]. Please include File fitting sanction. agreement depends solely on what type Number SR–C2–2012–036 on the The proposed rule change codifies of API the Participant opts to use to subject line. connect to the System. current Exchange requirements that Paper Comments enhance C2’s market surveillances and Finally, the proposed rule change will • System functionality. Proposed Rule help remove impediments to and Send paper comments in triplicate 6.34(c) is consistent with Rule 15c3–5 promote a free and open market and a to Elizabeth M. Murphy, Secretary, under the Act, and the Exchange national market system because it is Securities and Exchange Commission, believes the proposed rule change consistent with rules in place at other 100 F Street NE., Washington, DC promotes compliance by Participants exchanges and imposes substantially 20549–1090. All submissions should refer to File with the market access requirements similar requirements on Participants as Number SR–C2–2012–036. This file under that rule. The Exchange believes those rules do on those exchanges’ number should be included on the that proposed Rule 6.34(d) allows the members. Exchange to receive from Participants, subject line if email is used. To help the or categories of similarly situated B. Self-Regulatory Organization’s Commission process and review your Participants, information in a uniform Statement on Burden on Competition comments more efficiently, please use only one method. The Commission will C2 does not believe that the proposed 10 See supra note 5. post all comments on the Commission’s 11 15 U.S.C. 78f(b). rule change will impose any burden on Internet Web site (http://www.sec.gov/ 12 15 U.S.C. 78f(b)(5). competition that is not necessary or 13 Id. appropriate in furtherance of the 15 15 U.S.C. 78s(b)(3)(A). 14 15 U.S.C. 78f(b)(6). purposes of the Act. 16 17 CFR 240.19b–4(f)(6).

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rules/sro.shtml). Copies of the solicit comments on the proposed rule addition, the CFTC has proposed, submission, all subsequent change from interested persons. pursuant to the Dodd-Frank Act, that amendments, all written statements clearing of certain CDS products, I. Self-Regulatory Organization’s with respect to the proposed rule including iTraxx index CDS currently Statement of Terms of Substance of the change that are filed with the cleared by ICE Clear Europe, will Proposed Rule Change Commission, and all written become subject to mandatory clearing communications relating to the ICE Clear Europe proposes rule under Section 2(h) of the Commodity proposed rule change between the changes to provide for a clearing model Exchange Act, including for customers. Commission and any person, other than for CDS products whereby customers of Customers subject to the clearing those that may be withheld from the ICE Clear Europe have the ability to mandate will therefore need access to public in accordance with the clear CDS products through ICE Clear clearing in order to comply with their provisions of 5 U.S.C. 552, will be Europe (the ‘‘Customer CDS Clearing own clearing obligations. Moreover, ICE available for Web site viewing and Model’’). Additionally, ICE Clear Europe Clear Europe believes that extending printing in the Commission’s Public also seeks to amend, clarify and CDS clearing to customers of its Reference Room on official business consolidate the terms of certain rules Clearing Members will facilitate the days between the hours of 10:00 a.m. and procedures, including those that prompt and accurate settlement of and 3:00 p.m. Copies of such filing also relate to default and membership swaps and contribute to the will be available for inspection and requirements. safeguarding of securities and funds associated with swap transactions. copying at the principal offices of the II. Self-Regulatory Organization’s Exchange. All comments received will The Customer CDS Clearing Model Statement of Purpose of, and Statutory builds on the customer clearing be posted without change; the Basis for, the Proposed Rule Change Commission does not edit personal framework available for other products identifying information from In its filing with the Commission, ICE at ICE Clear Europe. For US customers, submissions. You should submit only Clear Europe included statements clearing would have to occur through a information that you wish to make concerning the purpose of and basis for registered futures commission merchant available publicly. All submissions the proposed rule change and discussed and/or broker-dealer (depending on should refer to File Number SR–C2– any comments it received on the whether the product is an index CDS or 2012–036, and should be submitted on proposed rule change. The text of these single-name CDS), consistent with the or before November 30, 2012. statements may be examined at the requirements of the Commodity places specified in Item IV below. ICE Exchange Act and Securities Exchange For the Commission, by the Division of Clear Europe has prepared summaries, Act of 1934. Non-US customers would Trading and Markets, pursuant to delegated be permitted to clear through a non-US authority.17 set forth in sections A, B, and C below, of the most significant aspects of such clearing member in accordance with Kevin M. O’Neill, statements.3 applicable local laws or through a Deputy Secretary. registered futures commission merchant [FR Doc. 2012–27360 Filed 11–8–12; 8:45 am] A. Self-Regulatory Organization’s and/or broker-dealer. BILLING CODE 8011–01–P Statement of Purpose of, and Statutory The terms of the Customer CDS Basis for, the Proposed Rule Change Clearing Model, as well as various As noted above, the principal purpose related enhancements to the clearing SECURITIES AND EXCHANGE of the proposed rule change is to model, are being proposed as COMMISSION provide for a Customer CDS Clearing amendments to the ICE Clear Europe Rules and CDS Procedures. Proposed [Release No. 34–68152; File No. SR–ICEEU– Model whereby customers of ICE Clear 2012–09] Europe Clearing Members have the changes to Part 1 of the Rules contain ability to clear CDS products through various clarifying and conforming Self-Regulatory Organizations; ICE ICE Clear Europe. In addition, ICE Clear amendments to definitions, various new Clear Europe Limited; Notice of Filing Europe proposes to amend its Rules and CDS-specific definitions used in new of Proposed Rule Change To Provide CDS Procedures in order to implement operative provisions, clarifications to for a Customer Clearing Model for CDS certain rule changes that are unrelated customer and proprietary account class Products and To Amend, Clarify and to Customer CDS Clearing Model. definitions that will now be relevant to Consolidate Certain Rules and Currently, ICE Clear Europe Clearing CDS, and clarifications to general Procedures Members are only able to clear CDS standards of Clearing Member products at ICE Clear Europe through responsibility and liability requested by November 5, 2012. their proprietary accounts and not on CDS Clearing Members. Other proposed Pursuant to Section 19(b)(1) of the behalf of their customers. The Customer changes reflect the incorporation into Securities Exchange Act of 1934 CDS Clearing Model will extend ICE the Rules of provisions that used to be (‘‘Act’’)1 and Rule 19b-4 thereunder,2 Clear Europe’s customer clearing in a separate master agreement entered notice is hereby given that on October models that are currently available for into between the Clearing Member and 22, 2012, ICE Clear Europe Limited other products to CDS products, with ICE Clear Europe. Proposed changes to (‘‘ICE Clear Europe’’) filed with the certain modifications appropriate for the Part 2 of the Rules provide updates Securities and Exchange Commission nature of the product. related to anti-money laundering (‘‘Commission’’) the proposed rule ICE Clear Europe has identified legislation applicable to customers, change described in Items I, II and III customer clearing of CDS products as a clarify membership standards for below, which items have been prepared service that has become increasingly Clearing Members, clarify the primarily by ICE Clear Europe. The important for market participants to obligations of Clearing Members with Commission is publishing this Notice to manage risk and express views with respect to customer accounts and respect to the credit markets. In proprietary accounts and clarify and/or 17 17 CFR 200.30–3(a)(12). restate certain provisions relating to 1 15 U.S.C. 78s(b)(2). 3 The Commission has modified the text of the Clearing Member default and 2 17 CFR 240.19b-4. summaries prepared by ICE Clear Europe. termination of clearing membership.

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The proposed changes in Part 3 of the various additional provisions dealing contains certain proposed conforming Rules clarify certain payment mechanics with CDS contracts cleared in the changes. Proposed changes in Part 4 of for Clearing Members with respect to customer account (including the the CDS Procedures contain updates amounts owed by their customers and representation of customer transactions concerning information that must be include a waiver of set-off by Clearing in relevant books and records and provided with respect to CDS contracts Members. Part 4 of the Rules contains treatment of customer transactions in and procedures for submission of CDS proposed changes related to the the case of credit events) and contracts for clearing. Proposed changes obligations of Clearing Members with elimination of the separate master in Part 5 of the CDS Procedures have respect to formation of contracts, agreement previously entered into been made in furtherance of the including whether such contract is between CDS Clearing Members and ICE Customer CDS Clearing Model to being entered into for the customer Clear Europe. Part 16 of the Rules address customer clearing in the context account or proprietary account, contains certain proposed amendments of the CDS Default Committee particularly in the context of the to the ICE Clear Europe FCM customer procedures. Part 6 of the CDS clearing of CDS on behalf of customers. clearing model that address the addition Procedures would be removed as no The proposed changes in Part 5 of the of CDS clearing and certain other longer necessary in light of the Rules address the delivery of margin clarifications and enhancements clearinghouse’s use of determinations from customers to Clearing Members requested by CDS Clearing Members. made by the ISDA Determinations and add provisions dealing with transfer In connection with the proposal of the Committees with respect to credit and of margin by security interest rather Customer CDS Clearing Model, ICE succession events. Proposed changes in Clear Europe proposes to establish in than title transfer. The proposed Part 7 address restructuring as a credit Exhibit 1 of the Rules certain standard changes to Part 6 of the Rules, which event with respect to CDS contracts terms (the Customer-CM CDS governs position limits, clarify the cleared in the customer account, Transactions Standard Terms) that will procedures for providing notice of such including the processing for triggering be applicable to Customer-CM CDS position limits. Some proposed minor settlement of such contracts. Part 8 of Transactions, which are CDS technical changes clarify further how the CDS Procedures contains proposed transactions between a Non-FCM/BD position limits apply in instances where clarifying changes to the procedures for Clearing Member and a non-U.S. contracts arise due to firm trades, listing new CDS Contracts, in particular customer. Under the proposed changes voiding or error policies. The proposed to enable the clearing house to respond to Rule 1516, all Non-FCM/BD Clearing in timely fashion to any prohibition on changes in Parts 7 and 8 of the Rules Members must agree to the applicability clarify that references in those parts of trading in CDS imposed under the EU of these terms as between them and Short Selling Regulation (Regulation the Rules (covering Settlement and each of their Customers. The Standard Delivery of Futures (Part 7) and Options 236/2012 dated 14 March 2012). Part 9 Terms provisions inter alia would of the CDS Procedures would be (Part 8)), which relate solely to Energy ensure that the terms of Customer-CM contracts, do not apply to CDS Customer updated to include various provisions CDS Transactions mirror the terms of previously included in the separate Accounts or Customers in the context of the cleared transaction, enable a CDS clearing. Part 9 of the Rules contain master agreement between CDS Clearing clearing member to pass on clearing Members and ICE Clear Europe as well various proposed changes to consolidate house performance (or non- and clarify the respective rights and as certain tax provisions relevant to performance) to their Customers, customer clearing. These updated obligations of ICE Clear Europe and facilitate the provision of margin to ICE provisions would apply to all CDS Clearing Members, in the case of a Clear Europe and amend provisions in Contracts, both customer positions and Clearing Member or ICE Clear Europe underlying agreements relating to events proprietary positions of CDS Clearing default and the procedures to be of default and close-out in order to Members. Part 10 of the CDS Procedures followed in determining a net sum ensure that the porting of contracts and would be revised to update the cross- payable to or receivable from a margin under the default rules will be references and definitions relevant to defaulting Clearing Member. Part 10 of effective. In addition, various consents customer clearing as they relate to index the Rules contains proposed clarifying would be supplied for ICE Clear Europe CDS Contracts. Part 11 of the CDS language providing more detail as to to update customer records in DTCC Procedures also would be revised to how a disciplinary or appeals panel and receive other information as could impose a sanction on a customer required relating to customers. As noted update the cross-references and and to determine liability or above, US customers would clear definitions relevant to customer clearing responsibility appropriately in any through an FCM/BD Clearing Member, as they relate to Single Name CDS instance where there is joint and the Customer-CM CDS Transactions Contracts. Similarly, Part 12 of the CDS misfeasance. Part 11 contains proposed Standard Terms would not apply to that Procedures would include updates to conforming changes related to the relationship. the cross-references and the definitions operation of the ICE Clear Europe The adoption of the Customer CDS relevant to customer clearing with guaranty funds, including proposed Clearing Model will also require respect to Sovereign Contracts. Finally, changes relating to the introduction of changes to ICE Clear Europe’s CDS Part 13 of the CDS Procedures would customer clearing. ICE Clear Europe will Procedures. Part 1 of the CDS add certain general procedures relating continue to operate separate guaranty Procedures contains various proposed to customer clearing of CDS contracts, funds for CDS products and for energy clarifying and conforming amendments including as to transfer of customer products. Part 12 of the Rules on to definitions, as well as new definitions positions. settlement finality contains proposed used in new operative provisions. Part ICE Clear Europe believes that the updates to conform to and be consistent 2 of the CDS Procedures also contains proposed Customer CDS Clearing Model with the new terms and definitions that various proposed clarifying and is consistent with the requirements of are part of the Customer CDS Customer conforming amendments to membership Section 17A of the Act and the CDS Model. Part 15 of the Rules, which requirements, largely resulting from procedures and regulations thereunder governs clearing of CDS generally, implementation of the Dodd-Frank Act. applicable to it. Specifically, the contains proposed updates to include Part 3 of the CDS Procedures also Customer CDS Clearing Model would

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promote market transparency for IV. Solicitation of Comments For the Commission, by the Division of derivatives markets, promote the Trading and Markets, pursuant to delegated prompt and accurate clearance of Interested persons are invited to authority.4 securities transactions, and derivative submit written data, views and Kevin M. O’Neill, agreements, contracts, and transactions, arguments concerning the foregoing, Deputy Secretary. and protect investors and the public including whether the proposed rule [FR Doc. 2012–27355 Filed 11–8–12; 8:45 am] interest. The Customer CDS Clearing change is consistent with the Act. BILLING CODE 8011–01–P Model is designed to permit customers Comments may be submitted by any of of Clearing Members to clear CDS the following methods: transactions, thereby permitting the • Electronic comments may be SECURITIES AND EXCHANGE increased use of clearing and the submitted by using the Commission’s COMMISSION prompt and accurate clearance and Internet comment form (http:// [Release No. 34–68151; File No. SR–OCC– settlement of securities transactions in www.sec.gov/rules/sro.shtml), or send 2012–20] furtherance of the goals of Section 17A an email to [email protected]. of the Act. ICE Clear Europe also Please include File No. SR–ICEEU– Self-Regulatory Organizations; The believes the proposed changes are 2012–09 on the subject line. Options Clearing Corporation; Notice specifically designed to protect of Filing and Immediate Effectiveness • investors and the public interest. The Paper comments should be sent in of Proposed Rule Change To Clarify non-Customer CDS Clearing Model triplicate to Elizabeth M. Murphy, the Applicability of OCC’s Rules proposed rule changes also achieve such Secretary, Securities and Exchange Governing Delivery of Treasury ends by clarifying the rights and Commission, 100 F Street NE., Securities Underlying Treasury obligations of Clearing Members and Washington, DC 20549–1090. Futures Contracts to Futures on ICE Clear Europe with respect to key All submissions should refer to File Treasury Securities With Maturities of aspects of the clearance and settlement Number SR–ICEEU–2012–09. This file Greater Than 25 Years process. number should be included on the November 5, 2012. B. Self-Regulatory Organization’s subject line if email is used. To help the Pursuant to Section 19(b)(1) of the Statement on Burden on Competition Commission process and review your Securities Exchange Act of 1934 comments more efficiently, please use 1 ICE Clear Europe does not believe that (‘‘Act’’) and only one method. The Commission will 2 the proposed rule change will have any Rule 19b–4 thereunder notice is post all comments on the Commission’s hereby given that on October 22, 2012, impact or impose any burden on Internet Web site (http://www.sec.gov/ competition. The Options rules/sro.shtml). Copies of the Clearing Corporation (‘‘OCC’’) filed C. Self-Regulatory Organization’s submission, all subsequent with the Securities and Exchange Statement on Comments on the amendments, all written statements Commission (‘‘Commission’’) the Proposed Rule Change Received From with respect to the proposed rule proposed rule change as described in Members, Participants, or Others change that are filed with the Items I, II and III below, which Items Commission, and all written have been prepared primarily by OCC. ICE Clear Europe has consulted communications relating to the OCC filed the proposed rule change extensively with CDS Clearing Members pursuant to Section 19(b)(3)(A) 3 of the and others in developing the Customer proposed rule change between the Act and Rule 19b–4(f)(4) 4 thereunder so CDS Clearing Model. ICE Clear Europe Commission and any person, other than that the proposal was effective upon has not solicited and does not intend to those that may be withheld from the filing with the Commission. The solicit comments regarding this public in accordance with the Commission is publishing this notice to proposed rule change. ICE Clear Europe provisions of 5 U.S.C. 552, will be solicit comments on the rule change has not received any unsolicited written available for Web site viewing and from interested parties. comments from interested parties. ICE printing in the Commission’s Public Clear Europe will notify the Reference Room, 100 F Street, NE., I. Self-Regulatory Organization’s Commission of any written comments Washington, DC 20549 on official Statement of the Terms of Substance of received by ICE Clear Europe. business days between the hours of the Proposed Rule Change 10:00 a.m. and 3:00 p.m. Copies of such III. Date of Effectiveness of the OCC proposes to clarify the filing also will be available for Proposed Rule Change and Timing for applicability of OCC’s rules governing Commission Action inspection and copying at the principal delivery of Treasury securities office of ICE Clear Europe and on ICE underlying Treasury futures contracts to Within 45 days of the date of Clear Europe’s Web site at https:// futures on Treasury securities with publication of this notice in the Federal www.theice.com/notices/ maturities of greater than 25 years. Register or within such longer period Notices.shtml?regulatoryFilings. II. Self-Regulatory Organization’s up to 90 days (i) as the Commission may All comments received will be posted designate if it finds such longer period Statement of the Purpose of, and without change; the Commission does Statutory Basis for, the Proposed Rule to be appropriate and publishes its not edit personal identifying reasons for so finding or (ii) as to which Change information from submissions. You the self-regulatory organization should submit only information that In its filing with the Commission, consents, the Commission will: OCC included statements concerning you wish to make available publicly. All (A) By order approve or disapprove submissions should refer to File the proposed rule change or 4 17 CFR 200.30–3(a)(12). Number SR–ICEEU–2012–09 and 1 15 U.S.C. 78s(b)(1). (B) institute proceedings to determine should be submitted on or before 2 17 CFR 240.19b–4. whether the proposed rule change November 30, 2012. 3 15 U.S.C. 78s(b)(3)(A). should be disapproved. 4 17 CFR 240.19b–4(f)(4).

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the purpose of and basis for the futures on Treasury securities will be as At any time within 60 days of the filing proposed rule change and discussed any set forth in the relevant exchange rules of such rule change, the Commission comments it received on the proposed and reflected in OCC’s procedures. This summarily may temporarily suspend rule change. The text of these statements amendment will clarify the applicability such rule change if it appears to the may be examined at the places specified of Rule 1302B to Ultra-Long Treasury Commission that such action is in Item IV below. OCC has prepared Futures, as well as accommodate futures necessary or appropriate in the public summaries, set forth in sections (A), (B), on other Treasury securities that may be interest, for the protection of investors, and (C) below, of the most significant introduced by an exchange at a later or otherwise in furtherance of the aspects of these statements.5 date that allow for delivery of Treasury purposes of the Act. (A) Self-Regulatory Organization’s securities with different maturity dates IV. Solicitation of Comments than those currently listed in Statement of the Purpose of, and Interested persons are invited to Statutory Basis for, the Proposed Rule Interpretation and Policy .02. OCC believes that the proposed rule submit written data, views, and Change change is consistent with the purposes arguments concerning the foregoing, The purpose of this proposed rule and requirements of Section 17A of the including whether the proposed rule change is to clarify the applicability of Securities Exchange Act of 1934, change is consistent with the Act. OCC’s Rules governing delivery of because they are designed to permit Comments may be submitted by any of Treasury securities underlying Treasury OCC to perform clearing services for the following methods: futures contracts to futures on Treasury products that are subject to the Electronic Comments securities with maturities of greater than jurisdiction of the Commodity Futures • Use the Commission’s Internet 25 years, which are currently traded on Trading Commission (‘‘CFTC’’) without comment form (http://www.sec.gov/ ELX Futures, L.P. (‘‘ELX’’). adversely affecting OCC’s obligations rules/sro.shtml); or Clearing members that are, or that with respect to the prompt and accurate represent, the seller of a physically- • Send an email to rule- clearance and settlement of securities [email protected]. Please include File settled Treasury future must make transactions or the protection of delivery of the underlying Treasury Number SR–OCC–2012–20 on the investors and the public interest. The subject line. security in accordance with the proposed rule change is not inconsistent procedures set forth in Rule 1302B. A with any rules of OCC, including any Paper Comments clearing member need not deliver that are proposed to be amended. • Treasury securities of a particular issue Send paper comments in triplicate to satisfy a delivery obligation.6 Instead, (B) Self-Regulatory Organization’s to Elizabeth M. Murphy, Secretary, Interpretation and Policy .02 to Rule Statement on Burden on Competition Securities and Exchange Commission, 1302B sets forth criteria for specific 100 F Street NE., Washington, DC OCC does not believe the proposed 20549–1090. Treasury securities that may be rule change would impose any burden delivered in settlement of Treasury on competition. All submissions should refer to File futures contracts. For example, for a Number SR–OCC–2012–20. This file Treasury futures contract with an (C) Self-Regulatory Organization’s number should be included on the underlying interest that is a Treasury Statement on Comments on the subject line if email is used. To help the bond, a clearing member may deliver Proposed Rule Change Received From Commission process and review your Treasury bonds, if not callable, with a Members, Participants or Others comments more efficiently, please use remaining term of at least fifteen years Written comments on the proposed only one method. The Commission will or, if callable, that are not callable for rule change were not and are not post all comments on the Commission’s at least 15 years. intended to be solicited with respect to Internet Web site (http://www.sec.gov/ ELX trades futures on Treasury the proposed rule change and none have rules/sro.shtml). Copies of the securities of various maturities, been received. submission, all subsequent including futures on treasury bonds amendments, all written statements with a maturity of greater than 25 years III. Date of Effectiveness of the with respect to the proposed rule (‘‘Ultra-Long Treasury Futures’’). Under Proposed Rule Change and Timing for change that are filed with the the rules of ELX, delivery obligations on Commission Action Commission, and all written Ultra-Long Treasury Futures may be The foregoing rule change has become communications relating to the satisfied by delivering Treasury bonds effective upon filing pursuant to Section proposed rule change between the that, if not callable, have a remaining 19(b)(3)(A)(iii) 7 of the Act and Rule Commission and any person, other than term of at least 25 years, or if callable, 19b–4(f)(4)(ii) 8 thereunder because it those that may be withheld from the are not callable for at least 25 years. affects a change in an existing service of public in accordance with the Interpretation and Policy .02 does not a registered clearing agency that provisions of 5 U.S.C. 552, will be specifically address the delivery of primarily affects the futures clearing available for Web site viewing and Treasury bonds with maturities of 25 operations of the clearing agency with printing in the Commission’s Public years or greater against Ultra-Long respect to futures that are not security Reference Section, 100 F Street NE., Treasury Futures. Accordingly, OCC is futures and it does not significantly Washington, DC 20549, on official proposing to amend Interpretation and affect any securities clearing operations business days between the hours of Policy .02 to Rule 1302B to provide that of the clearing agency or any related 10:00 a.m. and 3:00 p.m. Copies of such the characteristics of Treasury securities rights or obligations of the clearing filing also will be available for that may be delivered in settlement of agency or persons using such service. inspection and copying at the principal OCC will delay the implementation of office of OCC and on OCC’s Web site at 5 The Commission has modified the text of the the rule change until it is deemed (http://www.theocc.com/components/ summaries prepared by OCC. certified under CFTC Regulation § 40.6. docs/legal/rules_and_bylaws/ 6 Subject to the condition that all Treasury _ _ _ securities delivered against a single physically- sr occ 12 20.pdf). settled Treasury futures contract be of the same 7 15 U.S.C. 78s(b)(3)(A)(iii). All comments received will be posted issue. 8 17 CFR 240.19b–4(f)(4)(ii). without change; the Commission does

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not edit personal identifying II. Self-Regulatory Organization’s Currently, the Exchange provides a information from submissions. You Statement of the Purpose of, and credit of $0.0018 per share for should submit only information that Statutory Basis for, the Proposed Rule transactions in stocks with a per share you wish to make available publicly. All Change stock price of $1.00 or more when adding displayed liquidity to the submissions should refer to File In its filing with the Commission, the Number SR–OCC–2012–20 and should Exchange if either: self-regulatory organization included (i) The member organization has ADV be submitted on or before November 30, statements concerning the purpose of, 2012. that adds liquidity to the Exchange and basis for, the proposed rule change during the billing month (‘‘Adding For the Commission by the Division of and discussed any comments it received ADV,’’ which excludes any liquidity Trading and Markets, pursuant to delegated on the proposed rule change. The text added by a Designated Market Maker authority.9 of those statements may be examined at (‘‘DMM’’)) that is at least 1.5% of NYSE Kevin M. O’Neill, the places specified in Item IV below. CADV, and executes MOC and LOC The Exchange has prepared summaries, Deputy Secretary. orders of at least 0.375% of NYSE set forth in sections A, B, and C below, [FR Doc. 2012–27354 Filed 11–8–12; 8:45 am] CADV; or of the most significant parts of such (ii) The member organization has BILLING CODE 8011–01–P statements. Adding ADV that is at least 0.8% of A. Self-Regulatory Organization’s NYSE CADV, executes MOC and LOC SECURITIES AND EXCHANGE Statement of the Purpose of, and orders of at least 0.12% of NYSE CADV, and adds liquidity to the Exchange as a COMMISSION Statutory Basis for, the Proposed Rule Change Supplemental Liquidity Provider (‘‘SLP’’) for all assigned SLP securities [Release No. 34–68150; File No. SR–NYSE– 1. Purpose in the aggregate (including shares of 2012–56] The Exchange proposes to make both an SLP proprietary trading unit (‘‘SLP-Prop’’) and an SLP market maker Self-Regulatory Organizations; New changes to certain fees and credits within its Price List, which the (‘‘SLMM’’) of the same member York Stock Exchange LLC; Notice of organization) of more than 0.25% of Filing and Immediate Effectiveness of Exchange proposes to become operative on November 1, 2012. NYSE CADV. Proposed Rule Change Proposing To The Exchange proposes to modify the Make Changes to Certain Fees and Currently, for transactions in stocks second method by which member Credits Within the New York Stock with a per share stock price of $1.00 or organizations may qualify for the credit Exchange LLC Price List more, the Exchange charges a and add a third method by which transaction fee of $0.00055 per share for member organizations may qualify for November 5, 2012. all market at-the-close (‘‘MOC’’) and the credit when adding displayed limit at-the-close (‘‘LOC’’) orders from Pursuant to Section 19(b)(1) of the liquidity. More specifically, the any member organizations that execute Exchange proposes to revise the second Securities Exchange Act of 1934 an average daily trading volume 1 2 method to qualify for the credit such (‘‘Act’’) and Rule 19b–4 thereunder, (‘‘ADV’’) of MOC and LOC activity on notice is hereby given that, on October that a member organization would the Exchange in that month of at least qualify for the credit if the member 22, 2012, New York Stock Exchange 14 million shares. Member LLC (the ‘‘Exchange’’ or ‘‘NYSE’’) filed organization has Adding ADV that is at organizations that do not execute an least 0.8% of NYSE CADV, executes with the Securities and Exchange ADV of MOC and LOC activity on the MOC and LOC orders of at least 0.12% Commission (‘‘Commission’’) the Exchange of at least 14 million shares of NYSE CADV, and adds liquidity to proposed rule change as described in are charged a transaction fee of $0.00095 the Exchange as a SLP for all assigned Items I, II and III below, which Items per share. The Exchange proposes to SLP securities in the aggregate have been prepared by the Exchange. modify the threshold for the $0.00055 (including shares of both an SLP-Prop The Commission is publishing this transaction fee for MOC and LOC orders and an SLMM of the same member notice to solicit comments on the from an ADV of at least 14 million organization) of more than 0.15% of proposed rule change from interested shares to an ADV of at least 0.375% of NYSE CADV. Currently, a member persons. consolidated average daily volume in organization would have to provide NYSE-listed securities during the billing liquidity to the Exchange as an SLP for I. Self-Regulatory Organization’s month (‘‘NYSE CADV’’). all assigned SLP securities in the Statement of the Terms of Substance of The Exchange believes that modifying aggregate of more than 0.25% of NYSE the Proposed Rule Change the transaction fee threshold for MOC CADV, as opposed to the proposed The Exchange proposes to make and LOC orders with a per share stock 0.15% of NYSE CADV. The Exchange changes to certain fees and credits price of $1.00 or more as proposed believes that reducing the threshold to would provide a more flexible method within its Price List, which the 0.15% of NYSE CADV would allow by which member organizations may Exchange proposes to become operative more member organizations to qualify qualify for the lower fee for MOC and for the higher credit, and therefore, in on November 1, 2012. The text of the LOC orders by changing from a fixed turn, attract multiple sources of proposed rule change is available on the volume to one that will adjust liquidity to the Exchange. Exchange’s Web site at www.nyse.com, automatically based on higher or lower Finally, the Exchange proposes that a at the principal office of the Exchange, NYSE CADV. The Exchange believes member organization would qualify for and at the Commission’s Public that the proposed change would the credit of $0.0018 per share if the Reference Room. continue to allocate a lower fee to member organization has ADV that adds member organizations that make liquidity in customer electronic orders 9 17 CFR 200.30–3(a)(12). significant contributions to market to the Exchange (‘‘Customer Electronic 1 15 U.S.C. 78s(b)(1). quality by providing higher volumes of Adding ADV,’’ which would exclude 2 17 CFR 240.19b–4. liquidity. any liquidity added by a Floor broker,

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DMM, or SLP) during the billing month furthers the objectives of Section 6(b)(4) with higher volumes. In addition, the that is at least 0.5% of NYSE CADV, of the Act,5 in particular, because it Exchange believes that the proposed executes MOC and LOC orders of at provides for the equitable allocation of change is equitable and not unfairly least 0.12% of NYSE CADV, and has reasonable dues, fees, and other charges discriminatory because it would Customer Electronic Adding ADV among its members and issuers and encourage multiple sources of liquidity during the billing month that, taken as other persons using its facilities and by providing member organizations a percentage of NYSE CADV, is at least does not unfairly discriminate between without a DMM, SLP, or Floor broker equal to the member organization’s customers, issuers, brokers, or dealers. unit an alternative method to qualify for Customer Electronic Adding ADV The Exchange believes that modifying the credit. during September 2012 as a percentage the transaction fee threshold for MOC Finally, the Exchange notes that it of consolidated average daily volume in and LOC orders with a per share stock operates in a highly competitive market NYSE-listed securities during price of $1.00 or more is reasonable in which market participants can September 2012 (‘‘September 2012 because it provides a more flexible readily favor competing venues. In such NYSE CADV’’) plus 15%.3 For example, method by which member organizations an environment, the Exchange must if a member organization’s Customer may qualify for the lower fee for MOC continually review, and consider Electronic Adding ADV during and LOC orders. In addition, the adjusting, its fees and credits to remain September 2012 was 0.10% of proposed change is reasonable because competitive with other exchanges. For September 2012 NYSE CADV, then the the threshold would adjust the reasons described above, the member organization’s Customer automatically based on higher or lower Exchange believes that the proposed Electronic Adding ADV during the NYSE CADV. The Exchange believes rule change reflects this competitive billing month must be at least 0.115% that the proposed change to MOC and environment. of NYSE CADV in order to qualify for LOC orders is equitable and not unfairly discriminatory because all similarly B. Self-Regulatory Organization’s the proposed credit. Statement on Burden on Competition The Exchange believes that adding situated member organizations would be this third method by which member subject to the same fee structure, which The Exchange does not believe that organizations may qualify for the automatically adjusts based on the proposed rule change will impose $0.0018 per share credit would prevailing market conditions, and any burden on competition that is not encourage additional displayed would continue to allocate a lower fee necessary or appropriate in furtherance liquidity on the Exchange. In addition, to member organizations that make of the purposes of the Act. the method would provide discounts significant contributions to market quality by providing higher volumes of C. Self-Regulatory Organization’s that are reasonably related to the value Statement on Comments on the to the Exchange’s market quality liquidity. The Exchange believes that modifying Proposed Rule Change Received From associated with higher volumes and Members, Participants, or Others would encourage multiple sources of the second method by which member liquidity by providing member organizations may qualify for the credit No written comments were solicited organizations without a DMM, SLP, or of $0.0018 per share for transactions in or received with respect to the proposed Floor broker unit an alternative method stocks with a per share stock price of rule change. $1.00 or more when adding displayed to qualify for the credit when adding liquidity is reasonable because lowering III. Date of Effectiveness of the displayed liquidity. the threshold for SLP provide volume to Proposed Rule Change and Timing for The proposed changes are not Commission Action otherwise intended to address any other 0.15% of NYSE CADV would allow problem, and the Exchange is not aware more member organizations to qualify The foregoing rule change is effective for the reduced fee, which in turn of any significant problem that the upon filing pursuant to Section would attract multiple sources of 6 affected member organizations would 19(b)(3)(A) of the Act and liquidity to the Exchange. In addition, 7 have in complying with the proposed subparagraph (f)(2) of Rule 19b–4 the proposed change is equitable and changes. thereunder, because it establishes a due, not unfairly discriminatory because it fee, or other charge imposed by the 2. Statutory Basis would continue to provide a higher NYSE. The Exchange believes that the credit to member organizations that is At any time within 60 days of the proposed rule change is consistent with reasonably related to the value to the filing of such proposed rule change, the Section 6(b) of the Securities Exchange Exchange’s market quality associated Commission summarily may Act of 1934 (the ‘‘Act’’),4 in general, and with higher volumes. temporarily suspend such rule change if The Exchange believes the new it appears to the Commission that such method by which member organizations 3 For purposes of determining whether a firm that action is necessary or appropriate in the becomes a member organization after September may qualify for the credit for public interest, for the protection of 2012 qualifies for this proposed third method by transactions in stocks with a per share investors, or otherwise in furtherance of which member organizations may qualify for the stock price of $1.00 or more when the purposes of the Act. $0.0018 per share credit, the new member adding displayed liquidity is reasonable organization’s September 2012 NYSE CADV would IV. Solicitation of Comments be zero, and therefore, the member organization because it would encourage additional would only need to have Customer Electronic displayed liquidity on the Exchange. Interested persons are invited to Adding ADV of at least 0.5% of NYSE CADV and The Exchange believes the new method submit written data, views, and execute MOC and LOC orders of at least 0.12% of is equitable and not unfairly NYSE CADV to qualify for the credit of $0.0018 per arguments concerning the foregoing, share. Additionally, the September 2012 NYSE discriminatory because it is open to all including whether the proposed rule CADV of a firm that becomes a member member organizations on an equal basis change is consistent with the Act. organization during September 2012 would be and provides discounts that are Comments may be submitted by any of calculated based on the number of trading days reasonably related to the value to the during September 2012, not the number of trading the following methods: days during September 2012 during which the firm Exchange’s market quality associated was a member organization. 6 15 U.S.C. 78s(b)(3)(A). 4 15 U.S.C. 78f(b). 5 15 U.S.C. 78f(b)(4). 7 17 CFR 240.19b–4(f)(2).

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Electronic Comments SMALL BUSINESS ADMINISTRATION FOR FURTHER INFORMATION CONTACT: Grady B. Hedgespeth, Director, Office of • Use the Commission’s Internet Community Advantage Pilot Program Financial Assistance, U.S. Small comment form (http://www.sec.gov/ Business Administration, 409 Third AGENCY: U.S. Small Business rules/sro.shtml); or Street SW., Washington DC 20416; (202) Administration. • Send an email to rule- 205–7562; [email protected]. ACTION: Notice of extension of and [email protected]. Please include File For information regarding revisions to changes to Community Advantage Pilot the loan loss reserve requirements, Number SR–NYSE–2012–56 on the Program and request for comments. subject line. contact Brent Ciurlino, Director, Office SUMMARY: The Community Advantage of Credit Risk Management, U.S. Small Paper Comments (‘‘CA’’) Pilot Program is a pilot program Business Administration, 409 Third Street SW., Washington DC 20416; (202) • Send paper comments in triplicate to increase SBA-guaranteed loans to small businesses in underserved areas. 205–6538; [email protected]. to Elizabeth M. Murphy, Secretary, SUPPLEMENTARY INFORMATION: Securities and Exchange Commission, SBA continues to refine and improve 100 F Street NE., Washington, DC the design of the Community Advantage 1. Background Pilot Program. To support SBA’s 20549–1090. commitment to expanding access to On February 18, 2011, SBA issued a All submissions should refer to File capital for small businesses and notice and request for comments introducing the CA Pilot Program (76 FR Number SR–NYSE–2012–56. This file entrepreneurs in underserved markets, 9626). The CA Pilot Program was number should be included on the SBA is issuing this Notice to extend the introduced to increase the number of term of the CA Pilot Program, to modify subject line if email is used. To help the SBA-guaranteed loans made to small the loan loss reserve requirements for Commission process and review your businesses in underserved markets. The CA loans, and to revise other program comments more efficiently, please use February 18, 2011 notice provided an requirements, including certain of the only one method. The Commission will overview of the CA Pilot Program regulatory waivers. post all comments on the Commission’s requirements and, pursuant to the Internet Web site (http://www.sec.gov/ DATES: Effective Date: The changes to authority provided to SBA under 13 rules/sro.shtml). Copies of the the CA Pilot Program identified in this CFR 120.3 to suspend, modify or waive submission, all subsequent Notice will be effective November 9, certain regulations in establishing and amendments, all written statements 2012, and the CA Pilot Program will testing pilot loan initiatives, SBA with respect to the proposed rule remain in effect until March 15, 2017. modified or waived as appropriate change that are filed with the Comment Date: Comments must be certain regulations which otherwise received on or before January 8, 2013. Commission, and all written apply to 7(a) loans for the CA Pilot communications relating to the ADDRESSES: You may submit comments, Program. On September 12, 2011, SBA proposed rule change between the identified by SBA docket number SBA– issued a second notice modifying 2012–0016 by any of the following Commission and any person, other than certain of those regulatory waivers in methods: those that may be withheld from the order to permit Community Advantage • Federal eRulemaking Portal: http:// Lenders (‘‘CA Lenders’’) to pledge loans public in accordance with the www.regulations.gov. Follow the provisions of 5 U.S.C. 552, will be made under the CA Pilot Program (‘‘CA instructions for submitting comments. loans’’) as collateral for certain lender available for Web site viewing and • Mail: Community Advantage Pilot financings approved by SBA. (76 FR printing in the Commission’s Public Program Comments—Office of Financial 56262). Reference Room, 100 F Street NE., Assistance, U.S. Small Business SBA continues to refine and improve Washington, DC 20549, on official Administration, 409 Third Street SW., the design of the CA Pilot Program and, business days between the hours of Suite 8300, Washington, DC 20416. on February 8, 2012, SBA issued a third 10:00 a.m. and 3:00 p.m. Copies of the • Hand Delivery/Courier: Grady B. notice revising certain program filing also will be available for Hedgespeth, Director, Office of requirements in order to, among other inspection and copying at the principal Financial Assistance, U.S. Small things, change the maximum allowable office of the Exchange. All comments Business Administration, 409 Third interest rate for CA loans and permit CA received will be posted without change; Street SW., Washington, DC 20416. Lenders to contract with Lender Service the Commission does not edit personal SBA will post all comments on Providers. (77 FR 6619). To further identifying information from www.regulations.gov. If you wish to support SBA’s commitment to submissions. You should submit only submit confidential business expanding access to capital for small information that you wish to make information (CBI) as defined in the User businesses and entrepreneurs in available publicly. All submissions Notice at www.regulations.gov, please underserved markets, SBA is issuing submit the information to Grady B. should refer to File Number SR–NYSE– this fourth notice to further revise Hedgespeth, Director, Office of 2012–56 and should be submitted on or program requirements as described Financial Assistance, U.S. Small more fully below. before November 30, 2012. Business Administration, 409 Third For the Commission, by the Division of Street SW., Washington, DC 20416, or 2. Comments Trading and Markets, pursuant to delegated send an email to Although the extension of and authority.8 [email protected]. changes to the CA Pilot Program will be Kevin M. O’Neill, Highlight the information that you effective November 9, 2012, comments Deputy Secretary. consider to be CBI and explain why you are solicited from interested members of [FR Doc. 2012–27353 Filed 11–8–12; 8:45 am] believe SBA should hold this the public on all aspects of the CA Pilot information as confidential. SBA will Program. Comments must be submitted BILLING CODE 8011–01–P review the information and make the on or before the deadline for comments final determination whether it will listed in the DATES section. The SBA 8 17 CFR 200.30–3(a)(12). publish the information. will consider these comments and the

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need for making any revisions as a SBA guarantee exposure of $20 million their riskier credits. Finally, CA Lenders result of these comments. or less. CA Lenders with outstanding must also establish an additional reserve SBA guarantee exposure of more than for the guaranteed portion of loans sold 3. Changes to the Community $20 million must maintain fidelity into the secondary market because Advantage Pilot Program insurance coverage in a minimum secondary market loan sales create a Extension of the CA Pilot Program amount of $2,000,000. SBLCs that are direct risk to SBA. The total cash The CA Pilot Program is currently set not CA Lenders must comply with the reserve required for CA Lenders needs to expire on March 15, 2014. It was insurance requirement in the regulation. to be at a level that does not provide a anticipated that this would be sufficient Secondary Market Access significant disincentive for CA Lenders time to evaluate whether the CA Pilot to participate in the program. Therefore, SBA is revising the approval process SBA is revising the reserve requirement Program was succeeding in expanding concerning secondary market access for access to capital to small businesses in to permit CA Lenders to fund and CA Lenders. In the February 8, 2012 maintain the LLRA with an amount underserved markets and for SBA to notice SBA modified the requirements determine whether to take the necessary equal to 5% of the outstanding amount for CA Lenders to sell loans in the of the unguaranteed portion of the CA steps to make the program permanent. secondary market by allowing CA In response to comments received from Lender’s CA loan portfolio. CA Lenders Lenders to request authority ‘‘either at must deposit this required reserve prospective applicants to the CA Pilot the time of application or after one year Program, SBA has made significant amount in the LLRA no later than 45 of participation.’’ (77 FR 6619). SBA is days after the date of each CA loan program modifications to increase the revising this requirement to allow a CA overall interest and participation in the disbursement. In order to ensure that Lender to request access to the the 5% reserve is adequate for each program. However, CA Lenders have not secondary market with its application to had enough time to allow the program individual CA Lender, OCRM will participate in the CA Pilot or at any time review asset quality for each CA Lender to gain the traction necessary to thereafter. If authority is not awarded as adequately measure whether the goals of as a part of the quarterly review process. a result of the first request, the CA This will include reviewing current the CA Pilot Program are being met. For Lender should resolve any weakness or these reasons and due to the significant delinquency and default rates, current deficiency indicated as reasons for and projected purchase rates, and risk investment in time and resources that is rejection for secondary market authority necessary to become a CA Lender, SBA rating for each lender. OCRM will also before submitting a request for review compliance with the cash is extending the CA Pilot Program reconsideration. through March 15, 2017. reserve requirements, including Loan Loss Reserve Requirements examination of bank statements to Fidelity Insurance Requirement CA Lenders are required to create and ensure that the reserve is adequately When a CA Lender is approved to maintain a separate Loan Loss Reserve funded. OCRM reserves the right to participate in the CA Pilot Program it is Account (LLRA) to cover potential increase this level in its discretion. The identified as either a Small Business losses arising from defaulted CA loans. additional reserve requirement for loans Lending Company (SBLC) or a Non- In the February 18, 2011 Federal sold on the secondary market is Federally Regulated Lender (NFRL), Register Notice introducing the CA Pilot described in the next paragraph. depending on whether the lender is Program (76 FR 9626), SBA required all On February 8, 2012, SBA published subject to regulation by a State. CA Lenders to create and maintain the a notice in the Federal Register that Accordingly, all CA Lenders are SBA LLRA with a reserve amount equal to 15 made changes to certain CA Pilot Supervised Lenders, as that term is percent of the outstanding amount of Program requirements, including among defined in 13 CFR 120.10, and are the unguaranteed portion of a CA other things the requirements subject to all regulations applicable to Lender’s CA loan portfolio. This level of surrounding access to the secondary such lenders unless specifically waived loan loss reserve was based on the SBA market for CA Lenders. (77 FR 6619). In or modified in the regulatory waiver Microloan Program’s loan loss reserve that Federal Register notice, SBA stated section of the notices identified above. requirements. Upon further review, that CA Lenders granted access to the Agency regulations at 13 CFR however, SBA believes that the secondary market must have additional 120.470(e) require an SBLC to ‘‘maintain Microloan Program is not an appropriate reserves and must complete additional a Brokers Blanket Bond, Standard Form comparison for the CA Pilot Program training in secondary market activities 14, or Financing Companies Blanket because the maximum loan size in the and requirements before initiating Bond, Standard Form 15, or such other Microloan Program is $50,000, secondary market sales. The February 8, form of coverage as SBA may approve, compared to a maximum loan size of 2011 notice did not, however, state what in a minimum amount of $2,000,000 $250,000 permitted in the CA Pilot the additional reserve requirement executed by a surety holding a Program. The United States Department would be for CA Lenders with certificate of authority from the of Agriculture’s (USDA’s) Intermediary secondary market authority. With this Secretary of the Treasury pursuant to 31 Relending Program for loans in Notice, SBA is establishing an U.S.C. 9304–9308.’’ SBA believes that underserved rural areas, which has a additional reserve requirement of 3% of this amount of coverage is unnecessary maximum loan size of $250,000, the outstanding amount of the for most CA Lenders because the requires a 6% cash reserve. (7 CFR guaranteed portion of each CA loan sold maximum amount of any one CA loan 4274.332(b)(3)). SBA’s Intermediary in the secondary market. This level of (currently $250,000) is significantly less Lending Pilot Program, which has a additional reserve is based upon the than the maximum amount of any one maximum loan size of $200,000, dollar rate of repairs and denials for all 7(a) loan (currently $5,000,000). requires a 5% cash reserve. (13 CFR 7(a) loans purchased over the last two Therefore, SBA is modifying the 109.350). In addition, larger commercial calendar years (2.75%). Because CA regulation at 13 CFR 120.470(e) to lenders that provide warehouse lines of Lenders are generally inexperienced 7(a) reduce the minimum amount of credit to non-profit, mission-oriented lenders, the rate is set more coverage to $500,000 for CA Lenders lenders for loans to small businesses conservatively. CA Lenders must identified as SBLCs with outstanding typically require a reserve rate of 5% for deposit the required reserve amount

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covering the guaranteed portion of the Lenders to refinance their SBA Agency’s policy and procedures CA loan in the LLRA no later than 10 microloans or those of other Microloan governing Referral Agents and apply days after the CA loan has been sold in Intermediaries into CA loans will not with equal force and effect to the secondary market. In addition, to only free up microloan program organizations acting as agents for CA address the concern that a CA Lender resources to make more small dollar Lenders on CA loans. Mission-based with an unacceptable purchase rate loans, but also will make both programs organizations providing referral services might use secondary market sales to more attractive and thereby maximize to one or more CA Lenders may be significantly expand its CA loan lender participation and capital referred to as ‘‘Community Advantage portfolio, SBA is modifying its availability to underserved markets. Associates’’ (‘‘CA Associates’’) for the regulation at 13 CFR 120.660 for the Analysis indicates that this can be done purpose of the CA program and are duration of the pilot program, to allow without any significant additional risk subject to all of the same requirements the Director, Office of Credit Risk to the 7(a) program. Loan performance as other agents. SBA may place Management, discretion to suspend data from the 7(a) loan program, (for additional reporting requirements on secondary market authority for any CA loans less than $250,000) over the last CA Lenders that utilize CA Associates. Lender based on the risk characteristics 10 years show virtually identical or performance of the CA Lender’s cumulative default rates for loans that Guarantee Purchase portfolio. went to former micro borrowers versus Guarantee purchase requests for CA The 5% loan loss reserve amount for similarly-sized 7(a) loans that went to loans will be processed in SBA’s the unguaranteed portion of CA loans other borrowers (a 0.2 percent Commercial Loan Servicing Centers and the 3% loan loss reserve amount for difference). Therefore, SBA is revising (CLSCs) in Little Rock, AR and Fresno, the guaranteed portion of CA loans sold its policy to permit CA loans to be used CA. The CLSCs, which process in the secondary market may be kept in to refinance loans made by SBA similarly-sized loans, have a greater the same segregated bank account and Microlenders subject to the policies and capacity to receive and process must be carried as a restricted reserve procedures governing debt refinancing additional guarantee purchase requests on the CA Lender’s balance sheet for use for 7(a) loans as set forth in SBA Loan than the National Guaranty Purchase in meeting obligations the CA Lender Program Requirements and the CA Center, which processes the larger and has to cover losses from their CA Participant Guide. As such, the more complex standard 7(a) guarantee lending activity including but not refinancing of same-institution debt purchase requests. limited to defaults and guarantee cannot be processed on a delegated repairs, denials, withdrawals or basis and must be submitted to the General Information cancelations. This reserve may be used Standard 7(a) Loan Guaranty Processing These changes are limited to the CA to repay SBA in the event of a repair or Center. SBA will monitor the CA Pilot Pilot Program only. All other SBA denial. If the CA Lender chooses to use Program portfolio to ensure that such guidelines and regulatory waivers the reserve to repay SBA, the CA Lender refinancings are in the best interest of related to the CA Pilot Program remain must ensure that the reserve is the affected borrowers. unchanged. replenished to the required level within Financial Reports SBA has provided more detailed 45 days. All other requirements guidance in the form of a Participant regarding the creation and maintenance SBA regulations at 13 CFR Guide which has been updated and is of the LLRA stated in the February 18, 120.464(b)(2) require an SBA available on SBA’s Web site at http:// 2011 notice and all subsequent notices Supervised Lender to prepare financial www.sba.gov. SBA may provide remain unchanged. Failure to maintain reports on an accrual basis. In the additional guidance, through SBA the loan loss reserve account as required February 18, 2011 notice, however, SBA notices, which may also be published may result in removal from the CA Pilot modified 13 CFR 120.463(a) to eliminate on SBA’s Web site at http:// Program, the imposition of additional the requirement for CA Lenders to keep www.sba.gov/category/lender- controls or reserve amounts, and/or their books and records on an accrual navigation/forms-notices-sops/notices. other action permitted by SBA basis. In order to be consistent with that Questions regarding the CA Pilot regulation or otherwise by law. Based modification, SBA is waiving 13 CFR Program may be directed to the Lender on the risk characteristics or 120.464(b)(2) for purposes of the CA Relations Specialist in the local SBA performance of a CA Lender, OCRM in Pilot Program. district office. The local SBA district its discretion may require additional CA Associate office may be found at http:// amounts to be included in the LLRA or www.sba.gov/about-offices-list/2. may suspend secondary market The CA Pilot Program was originated privileges. under the basic premise that mission- Authority: 15 U.S.C. 636(a)(25) and 13 based lenders are the optimal CFR 120.3. Refinancing of SBA Microloans distribution tool to get capital to small Dated: October 15, 2012. Currently, CA loans may not be used businesses in underserved markets. Karen G. Mills, to refinance loans made by Microloan While this premise remains true, SBA Administrator. has recognized that there are many Intermediaries in SBA’s Microloan [FR Doc. 2012–27334 Filed 11–8–12; 8:45 am] Program. Because of the natural mission-based organizations that do not BILLING CODE 8025–01–P synergies that exist between the SBA have the capacity to become CA Lenders Microloan Program and the CA Pilot but can nevertheless provide referral Program, a number of CA Lenders have services to CA Lenders. Linking higher asked SBA to reconsider this capacity CA Lenders with these other SOCIAL SECURITY ADMINISTRATION prohibition. The CA Pilot Program was mission-based organizations should Agency Information Collection designed as a complement to the SBA increase the flow of capital to small Activities: Proposed Request and Microloan Program, especially when businesses in underserved markets. Comment Request small business borrowers’ capital needs Current SBA regulations at 13 CFR part exceed the Microloan Program’s $50,000 103 and SBA’s Standard Operating The Social Security Administration maximum loan limit. Allowing CA Procedure (SOP) 50 10 5(E) set forth the (SSA) publishes a list of information

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collection packages requiring clearance Office of Management and Budget, Attn: Social Security benefits, SSA uses by the Office of Management and Desk Officer for SSA, Fax: 202–395– criteria under section 216(h)(3) of the Budget (OMB) in compliance with 6974, Email address: Social Security Act (Act), deemed child Public Law 104–13, the Paperwork [email protected]. provision. SSA may deem a child to an Reduction Act of 1995, effective October (SSA) insured individual if: (1) The insured 1, 1995. This notice includes revisions Social Security Administration, DCRDP, individual presents SSA with to OMB-approved information Attn: Reports Clearance Director, 107 satisfactory evidence of parenthood and collections. Altmeyer Building, 6401 Security was living with or contributing to the SSA is soliciting comments on the Blvd., Baltimore, MD 21235, Fax: child’s support at certain specified accuracy of the agency’s burden 410–966–2830, Email address: times; or (2) the insured individual (a) estimate; the need for the information; [email protected]. acknowledged the child in writing; (b) its practical utility; ways to enhance its I. The information collections below was court decreed as the child’s parent; quality, utility, and clarity; and ways to are pending at SSA. SSA will submit minimize burden on respondents, or (c) was court ordered to support the them to OMB within 60 days from the child. To obtain this information, SSA including the use of automated date of this notice. To be sure we uses Form SSA–2519, Child collection techniques or other forms of consider your comments, we must Relationship Statement. Respondents information technology. Mail, email, or receive them no later than January 8, are people with knowledge of the fax your comments and 2013. Individuals can obtain copies of relationship between certain individuals recommendations on the information the collection instruments by writing to collection(s) to the OMB Desk Officer the above email address. filing for Social Security benefits and and SSA Reports Clearance Officer at 1. Child Relationship Statement—20 their alleged biological children. the following addresses or fax numbers. CFR 404.355 & 404.731—0960–0116. To Type of Request: Revision of an OMB- (OMB) help determine a child’s entitlement to approved information collection.

Average Number of Frequency of burden per Estimated total Modality of collection respondents response response annual burden (minutes) (hours)

SSA–2519 ...... 50,000 1 15 12,500

2. Pain Report-Child—20 CFR SSI applicants or claimants in self-help function for purposes of determining 404.1512 and 416.912—0960–0540. situations, with a convenient way to disability under the Act. The Before SSA can make a disability record information claimants’ pain or respondents are applicants for, or determination for a child, we require other symptoms. The State disability claimants of, SSI payments. evidence from Supplemental Security determination services adjudicators and Type of Request: Revision of an OMB- Income (SSI) applicants or claimants to administrative law judges then use the approved information collection. prove their disability. Form SSA–3371– information from Form SSA–3371–BK BK provides disability interviewers, and to assess the effects of symptoms on

Average Number of Frequency of burden per Estimated total Modality of collection respondents response response annual burden (minutes) (hours)

SSA–3371 ...... 250,000 1 15 62,500

3. Internet and Automated Telephone unavailable (e.g., lost, stolen, mutilated), telephone options reduce requests to the Request for Replacement Forms SSA– an individual may use SSA’s Internet National 800 Number Network (N8NN) 1099/SSA–1042S—20 CFR 401.45— request form or automated telephone and visits to local Social Security field 0960–0583. Title II recipients use Forms application to request a replacement offices. The respondents are title II SSA–1099 and SSA–1042S, Social SSA–1099 and SSA–1042S. SSA uses recipients who wish to request a Security Benefit Statement, to determine the information from the Internet and replacement SSA–1099 or SSA–1042S if their Social Security benefits are automated telephone requests to verify via the Internet and telephone. taxable and the amount they need to the identity of the requestor and to report to the Internal Revenue Service. provide replacement copies of the Type of Request: Revision of an OMB- In cases where the original forms are forms. The Internet and automated approved information collection.

Average Number of Frequency of burden per Estimated total Modality of completion respondents response response annual burden (minutes) (hours)

Internet Requests ...... 145,390 1 10 24,232 Automated Telephone Requests ...... 190,413 1 2 6,347 N8NN ...... 566,667 1 3 28,333 Calls to local field offices ...... 783,333 1 3 39,167 Other (program service centers) ...... 90,000 1 3 4,500

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Average Number of Frequency of burden per Estimated total Modality of completion respondents response response annual burden (minutes) (hours)

Totals ...... 1,775,803 ...... 102,579

4. Important Information About Your SSA cannot approve a request for rights. The respondents are overpaid Appeal, Waiver Rights, and Repayment waiver; and (3) the availability of a claimants requesting a waiver of Options—20 CFR 404.502–521—0960– different rate of withholding when SSA recovery for the overpayment, 0779. When SSA accidentally overpays proposes the full withholding rate. SSA reconsideration of the fact of the beneficiaries, the agency informs them uses Form SSA–3105, Important overpayment, or a lesser rate of of the following rights: (1) The right to Information About Your Appeal, Waiver withholding of the overpayment. reconsideration of the overpayment Rights, and Repayment Options, to Type of Request: Extension of an determination; (2) the right to request a explain these rights to overpaid waiver of recovery and the automatic individuals, and allow them to notify OMB-approved information collection. scheduling of a personal conference if SSA of their decision(s) regarding these

Average Number of Frequency of burden per Estimated total Modality of completion respondents response response annual burden (minutes) (hours)

SSA–3105 ...... 80,000 1 15 20,000

II. SSA submitted the information State vocational rehabilitation (VR) causality statements, State VR agencies collection below to OMB for clearance. agencies submit Form SSA–199 to SSA submit written requests as stipulated in Your comments regarding the to obtain reimbursement of costs SSA’s regulations within the Code of information collection would be most incurred for providing VR services. SSA Federal Regulations. In most cases, SSA useful if OMB and SSA receive them 30 requires state VR agencies to submit requires adherence to cost containment days from the date of this publication. reimbursement claims for the following policies and procedures as well as To be sure we consider your comments, categories: causality statements prior to we must receive them no later than (1) Claiming reimbursement for VR determining whether to reimburse the December 10, 2012. Individuals can services provided; (2) certifying State VR agencies. SSA uses the obtain copies of the OMB clearance adherence to cost containment policies information on the SSA–199, along with packages by writing to and procedures; and (3) preparing the written documentation, to determine [email protected]. causality statements. whether or not, and how much, to pay The respondents mail the paper copy the State VR agencies under SSA’s VR Vocational Rehabilitation Provider of the SSA–199 to SSA for consideration program. Respondents are State VR Claim—20 CFR 404.2108(b), and approval of the claim for agencies who offer vocational and 404.2117(c)(1)&(2), 404.2101(a)&(b), reimbursement of cost incurred for SSA employment services to Social Security 404.2121(a), 416.2208(b), beneficiaries. For claims certifying and SSI recipients. 416.2217(c)(1)&(2), 416.2201(a)&(b), adherence to cost containment policies Type of Request: Revision of an OMB- 416.2221(a), 34 CFR 361—0960–0310. and procedures, or for preparing approved information collection.

Average Number of Frequency of Number of burden per Estimated total Modality of collection respondents response responses response annual burden (minutes) (hours)

a. Claiming Reimbursement on SSA–199—20 CFR 404.2108(b) & 416.2208(b) ...... 80 160 (12,800) 23 4,907 b. Certifying Adherence to Cost Containment Policy and Procedures—20 CFR 404.2117(c)(1)&(2), 416.2217(c)(1)&(2) & 34 CFR 361 ...... 80 1 (80) 60 80 c. Preparing Causality Statements—20 CFR 404.2121(a), 404.2101(a), 416.2201(a), & 416.2221(a) ...... 80 2.5 (200) 100 333

Totals ...... 80 ...... (13,080) ...... 5,320

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Dated: November 5, 2012. provided to Diplomatic Security. One of 2012–0405 using any of the following Faye Lipsky, the following forms of valid photo methods: Reports Clearance Director, Social Security identification will be required for • Government-wide rulemaking Web Administration. admission to the Department of State site: Go to http://www.regulations.gov [FR Doc. 2012–27358 Filed 11–8–12; 8:45 am] building: U.S. driver’s license, passport, and follow the instructions for sending BILLING CODE 4191–02–P U.S. Government ID or other your comments electronically. Government-issued photo ID. • Mail: Send comments to the Docket Personal data is requested pursuant to Management Facility; U.S. Department DEPARTMENT OF STATE Public Law 99–399 (Omnibus of Transportation, 1200 New Jersey Diplomatic Security and Antiterrorism Avenue SE., West Building Ground [Public Notice 8084] Act of 1986), as amended; Public Law Floor, Room W12–140, Washington, DC 107–56 (USA PATRIOT Act); and 20590. Defense Trade Advisory Group; Notice Executive Order 13356. The purpose of • Fax: Fax comments to the Docket of Open Meeting the collection is to validate the identity Management Facility at 202–493–2251. • SUMMARY: The Defense Trade Advisory of individuals who enter Department Hand Delivery: Bring comments to Group (DTAG) will meet in open facilities. The data will be entered into the Docket Management Facility in session from 1:00 p.m. until 5:00 p.m. the Visitor Access Control System Room W12–140 of the West Building on Wednesday, November 28, 2012, in (VACS–D) database. Please see the Ground Floor at 1200 New Jersey the East Auditorium, U.S. Department of Security Records System of Records Avenue SE., Washington, DC, between 9 State, Harry S. Truman Building, Notice (State-36) at http:// a.m. and 5 p.m., Monday through Washington, DC. Entry and registration www.state.gov/documents/organization/ Friday, except Federal holidays. will begin at 12:00 p.m. Please use the 103419.pdf for additional information. Privacy: We will post all comments building entrance located at 21st Street For additional information, contact we receive, without change, to http:// NW., Washington, DC, between C & D Patricia Slygh, PM/DDTC, SA–1, 12th www.regulations.gov, including any Streets. The membership of this Floor, Directorate of Defense Trade personal information you provide. advisory committee consists of private Controls, Bureau of Political-Military Using the search function of our docket sector defense trade representatives, Affairs, U.S. Department of State, Web site, anyone can find and read the appointed by the Assistant Secretary of Washington, DC 20522–0112; telephone comments received into any of our State for Political-Military Affairs, who (202) 663–2830; FAX (202) 261–8199; or dockets, including the name of the advise the Department on policies, email [email protected]. individual sending the comment (or regulations, and technical issues Dated: November 6, 2012. signing the comment for an association, affecting defense trade. The purpose of Robert S. Kovac, business, labor union, etc.). You may review DOT’s complete Privacy Act the meeting will be to discuss current Designated Federal Officer, Defense Trade defense trade issues and topics for Advisory Group, Department of State. Statement in the Federal Register further study. Specific agenda topics published on April 11, 2000 (65 FR [FR Doc. 2012–27442 Filed 11–8–12; 8:45 am] 19477–78). will be posted on the Directorate of BILLING CODE 4710–25–P Defense Trade Controls’ Web site, at Docket: To read background www.pmddtc.state.gov approximately documents or comments received, go to http://www.regulations.gov at any time 10 days prior to the meeting. DEPARTMENT OF TRANSPORTATION Members of the public may attend or to the Docket Management Facility in Room W12–140 of the West Building this open session and will be permitted Federal Aviation Administration to participate in the discussion in Ground Floor at 1200 New Jersey accordance with the Chair’s [Summary Notice No. PE–2012–46] Avenue SE., Washington, DC, between 9 instructions. Members of the public a.m. and 5 p.m., Monday through Petition for Exemption; Summary of Friday, except Federal holidays. may, if they wish, submit a brief Petition Received statement to the committee in writing. FOR FURTHER INFORMATION CONTACT: As access to the Department of State AGENCY: Federal Aviation Mark Forseth, ANM–113, (425) 227– facilities is controlled, persons wishing Administration (FAA), DOT. 2796, Federal Aviation Administration, to attend the meeting must notify the ACTION: Notice of petition for exemption 1601 Lind Avenue SW., Renton, WA DTAG Alternate Designated Federal received. 98057–3356, or Andrea Copeland (202) Officer (DFO) by close of business 267–8081, Office of Rulemaking (ARM– Friday, November 23, 2012. If notified SUMMARY: This notice contains a 1), Federal Aviation Administration, after this date, the Department’s Bureau summary of a petition seeking relief 800 Independence Avenue SW., of Diplomatic Security may not be able from specified requirements of 14 CFR. Washington, DC 20591. to complete the necessary processing The purpose of this notice is to improve This notice is published pursuant to required to attend the plenary session. the public’s awareness of, and 14 CFR 11.85. A person requesting reasonable participation in, this aspect of the FAA’s Issued in Washington, DC, on November 5, accommodation should notify the regulatory activities. Neither publication 2012. Alternate DFO by the same date. of this notice nor the inclusion or Ida M. Klepper, omission of information in the summary Anyone who wishes to attend this Acting Director, Office of Rulemaking. plenary session should provide: his/her is intended to affect the legal status of name; company or organizational the petition or its final disposition. Petition for Exemption affiliation (if any); date of birth; and DATES: Comments on this petition must Docket No.: FAA–2012–0405. identifying data such as driver’s license identify the petition docket number Petitioner: The Boeing Company. number, U.S. Government ID, or U.S. involved and must be received on or Section of 14 CFR Affected: Military ID, to the DTAG Alternate DFO, before November 29, 2012. § 25.562(b)(2) at Amendment 25–64. Patricia Slygh, via email at ADDRESSES: You may send comments Description of Relief Sought: Relief [email protected]. A RSVP list will be identified by Docket Number FAA– from the misalignment and roll test

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requirement for flight-deck seats on Avenue SE., Washington, DC 20590. received, go to www.regulations.gov at Boeing Model 767–2C airplanes. Please send an email to E´ lan Flippin at any time or to the U.S. Department of [FR Doc. 2012–27434 Filed 11–8–12; 8:45 am] [email protected] with your contact Transportation, 1200 New Jersey Ave. BILLING CODE 4910–13–P information if you plan to attend the SE., Docket Operations, M–30, West December meeting in Washington, DC Building Ground Floor, Room W12–140, FTA encourages public participation at Washington, DC 20590 between 9:00 DEPARTMENT OF TRANSPORTATION these meetings. However, comments a.m. and 5:00 p.m., Monday through must be submitted in writing directly to Friday, except Federal holidays. Federal Transit Administration the official docket per the instructions SUPPLEMENTARY INFORMATION: [Docket Number FTA–2012–0054] found in the ADDRESSES section of this notice by January 7, 2013. Table of Contents Fiscal Year 2013 Public Transportation Details and updates regarding these I. Overview on Indian Reservations Program meetings will be posted on the FTA II. Questions on Proposed Tribal Transit Web site www.fta.dot.gov, Tribal Formula Program Allocations AGENCY: Federal Transit Administration, Technical Assistance (TTAP) Program III. Questions on Proposed Tribal Transit DOT. (www.ltap.org), and National RTAP Discretionary Program ACTION: Request for comment; Program www.Nationalrta.org. IV. Questions on Proposed Cost Sharing, Announcement of public meetings. FOR FURTHER INFORMATION CONTACT: Matching, and Indirect Costs V. Proposed Terms and Conditions of the Lorna Wilson, Federal Transit SUMMARY: This notice announces Tribal Transit Program changes in the Public Transportation on Administration, 1200 New Jersey Ave. I. Overview Indian Reservations program (Tribal SE., E46–305, Washington, DC 20590, Transit Program) in accordance with the phone: (202) 366–0893, fax: (202) 366– Section 3013 of Safe, Accountable, 3809, or email, [email protected] or Moving Ahead for Progress in the 21st ´ Flexible, Efficient Transportation Equity Century Act (MAP–21) (Pub. L. 112– Elan Flippin at [email protected]. Act: A Legacy for Users (SAFETEA–LU), 141), which authorizes the program for ADDRESSES: Comments should be (Pub. L. 109–59 (August 10, 2005)) Federal fiscal years (FY) 2013 and 2014. submitted by one of the following established the Public Transportation on MAP–21 was signed into law by methods, identifying your submission Indian Reservations Program (Tribal President Barack Obama on July 6, 2012 by docket number FTA–2012–0054. Transit Program). The program and became effective on October 1, (1) Federal eRulemaking Portal: Go to authorized direct grants ‘‘under such 2012. This notice responds to the new http://www.regulations.gov and follow terms and conditions as may be legislation under the Tribal Transit the online instructions for submitting established by the Secretary’’ to Indian Program by: (1) Introducing FTA’s comments. tribes for any purpose eligible under (2) Mail: Docket Management Facility: consultation process and schedule for FTA’s Grants for Rural Areas Formula U.S. Department of Transportation, 1200 implementing changes due to MAP–21; Program, 49 U.S.C. 5311 (Section 5311 New Jersey Avenue SE., Docket (2) describing and seeking comment on program). The Tribal Transit Program Operations, M–30 West Building the methodology for the formula was implemented by FTA in Ground Floor, Room W12–140, West allocation and the assumptions made consultation with Indian tribes Building, Ground Floor, Room W12– regarding who is eligible for the formula consistent with the principles and 140, Washington, DC 20590–0001. program; (3) seeking comment on the (3) Hand Delivery or Courier: Docket policies set forth in Presidential terms and conditions for the formula Management Facility: U.S. Department Executive Order 13175, ‘‘Consultation and discretionary components of the of Transportation, 1200 New Jersey and Coordination with Indian Tribal program; and (4) seeking comments on Avenue SE., Docket Operations, M–30 Governments,’’ and U.S. Department of how the discretionary program West Building Ground Floor, Room Transportation Order 5301.1, resources should be allocated. W12–140, West Building, Ground Floor, ‘‘Department of Transportation DATES: Comments must be submitted by Room W12–140, Washington, DC Programs, Policies, and Procedures January 8, 2013. Late-filed comments 20590–0001 between 9 a.m. and 5 p.m. affecting American Indians, Alaska will be considered to the extent Eastern time, Monday through Friday, Natives and tribes for programs affecting practicable. except Federal holidays. Indian tribal governments.’’ Under Outreach and Public Meeting: FTA (4) Fax: 202–493–2251. SAFETEA–LU, the Tribal Transit will provide outreach in conjunction You must include the agency name Program was a discretionary program, with the National Tribal Transportation (Federal Transit Administration) and and funded for a total of $42 million Conference, sponsored by the Northwest docket number (FTA–2012–0054) for over the life of SAFETEA–LU and its Tribal Transit Assistance Program this notice at the beginning of your extensions, with approximately $15 (TTAP). The meeting will be held on comments. Submit two copies of your million available in each of the last four November 14–15, 2012 in Phoenix, comments if you submit them by mail. years. Arizona at the Pointe Hilton Tapatio For confirmation that FTA received This notice describes changes to the Cliffs Resort, 11111 North 7th Street. your comments, include a self- Tribal Transit Program as a result of the The first session is scheduled from 1:30 addressed stamped postcard. Note that Moving Ahead for Progress in the 21st p.m. to 5:00 p.m. on November 14th and all comments received will be posted Century Act (MAP–21). MAP–21 the second session on November 15th without change to www.regulations.gov modifies the Tribal Transit Program and from 8:00 a.m. to 12:00 p.m. All including any personal information provides $25 million for formula participants must pre-register for the provided and will be available to allocation and $5 million for meeting and may register online at internet users. You may review DOT’s discretionary allocation in each of fiscal http://ttap.colostate.edu. Additionally, complete Privacy Act Statement years 2013 and 2014. Through this FTA will hold a public meeting in published in the Federal Register on notice, FTA seeks comment on the data Washington, DC on December 10, 2012, April 11, 2000 (65 FR 19477). assumptions and methods FTA will use at the U.S. Department of For access to the docket to read to allocate these formula funds. FTA Transportation, 1200 New Jersey background documents and comments will continue to allocate the $5 million

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in discretionary funding competitively. where the service is being operated. recognized Indian tribes for any purpose This notice also seeks comment on how Therefore, tribes may report their total under the Section 5311 program. The these funds will be competed. For both vehicle revenue miles, regardless of funds set aside for Indian tribes in the the formula and discretionary program, funding source, to the NTD, and States Tribal Transit Program are not meant to FTA seeks comments on the terms and may include tribal vehicle revenue replace or reduce funds that Indian conditions. miles in their reporting to the NTD. tribes receive from State through FTA’s b. When another local government Section 5311 program. Tribal Transit II. Questions on Proposed Tribal entity pays an Indian tribe to operate Transit Formula Program Allocations funds are meant to complement Section service in an off-reservation jurisdiction, 5311 funds that applicants may be The Tribal Transit Formula Program should 100% of that service operated by receiving. In light of the $25 million distributes $25 million to eligible Indian the Indian tribe count towards the formula program, FTA seeks comments tribes providing public transportation Tribal Transit Program formula? FTA on the eligibility of applicants, eligible on tribal lands. Since FY 2006, the proposes to count 100% of service projects, and cost sharing for the National Transit Database (NTD) operated by Indian tribes towards the discretionary program. Program reporting requirement has applied to the Tribal Transit Program apportionment. requirements of the Tribal Transit Tribal Transit Program. FTA proposes to This interpretation is consistent with Program under SAFETEA–LU can be limit eligible recipients to those ‘‘each Indian tribe providing public accessed at http://www.fta.dot.gov/ registered in the NTD. Tribes that transportation service.’’ documents/06–6911.pdf. operate public transportation services, c. When an Indian tribe pays another FTA seeks comments on the following but which do not yet participate in the local government entity to extend questions: Tribal Transit Program, may file a report service to the Reservation, should a pro- a. Should eligible applicants under with the NTD on a voluntary basis for rated share of the local government’s the discretionary program be restricted inclusion in future apportionments (FY vehicle revenue miles be counted based on the availability of formula 2014 and beyond.) Apportionments will towards the Tribal Transit formula? FTA funds? be based on a statutory formula which proposes to count a pro-rated share of b. If the discretionary program should includes three tiers. Tiers 1 and 2 are the operator’s vehicle revenue miles be restricted, should applicants and based on historical data reported to the towards the Tribal Transit Program projects be limited based on the amount NTD by Indian tribes who received apportionment, based on the portion of of formula allocation received? Section 5311 funding in prior years the total operating expenses provided by c. Should a portion of discretionary (including discretionary Tribal Transit the Indian tribe. This share then would program funds be set aside for Program funds); Tier 3 is based on 2010 count towards both the Rural and Tribal 1. Start-up projects, or U.S. Census data. Transit program formulas. 2. Planning projects, or The statutory tiers for the formula are: d. Should FTA consider tribes that 3. Expansion of services? Tier 1—50 percent based on vehicle actually are providing public revenue miles as reported to the NTD. transportation on Indian reservations d. Should FTA establish minimum Tier 2—25 percent apportioned when no revenue miles are reported to and maximum grant awards to ensure equally amongst Indian tribes providing the NTD for funding under Tier 3? FTA that grant funding is large enough to aid at least 200,000 vehicle revenue miles as proposes that tribes that previously Indian tribes? reported to the NTD Secretary. received capital assistance through the e. Should operating assistance Tier 3—25 percent based on Indian Tribal Transit Program should be continue to be eligible under the tribes providing public transportation included in Tier 3 of the Tribal Transit discretionary program? If so, what type on reservations in which more than Program formula, which is based on of operating expenses? 1,000 low income individuals reside, low-income population on Tribal lands. f. Should FTA prioritize projects for with no tribe receiving more than e. Should FTA consider allowing funding as a part of the evaluation $300,000 for this tier. Tribal Transit Program grantees who criteria? If so, what factors should be In establishing the apportionment were otherwise exempt from reporting used to prioritize projects (continuation methodology, FTA is proposing a based on grant dollar amount (under services, start-ups, matching funds, number of key assumptions shown $50,000) be given an opportunity to etc.)? below. FTA seeks comment on the report to the NTD or to FTA for IV. Questions on Proposed Cost following questions: inclusion in the FY 2013 Sharing, Matching, and Indirect Costs a. Should FTA include vehicle apportionment? revenue miles from Indian tribes in both f. For Indian tribes that have multiple FTA recognizes the particular the Tribal Transit Program formula operators, should FTA consolidate the challenges tribes may have providing a apportionment and the Rural Area service data for all operators into a local match, but to ensure that Formula Program apportionment? FTA single apportionment? participants in this program have a proposes to allow vehicle revenue miles g. For Indian tribes that share vested interest we propose requiring from Indian tribes to count towards both reservation lands, such as in Oklahoma, some local match. Matching funds may formula apportionments. Normally, FTA how should FTA conduct the be provided from Federal agencies other does not allow a single vehicle revenue apportionment of funds? than the Department of Transportation mile to count twice towards different h. In some instances tribal operators with the exception of Federal Lands formulas (e.g., service between a rural may serve multiple reservations. Should Highways program funds, administered area and an urbanized area (UZA) must FTA combine poverty data for all by the Federal Highway Administration be counted the Rural Area Formula reservations served into a single and Indian Reservation Roads (IRR) Program apportionment or the apportionment? Program. Urbanized Area Formula Program FTA seeks comments on the following apportionment, but not both). The III. Questions on Proposed Tribal questions: Tribal Transit Program formula, Transit Discretionary Program a. Should FTA require an 80/20 however, refers to ‘‘Indian tribe[s] $5 million in discretionary funds are Federal/local match for tribes for both providing public transportation,’’ not authorized for grants to federally- capital and operating assistance under

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both the formula and discretionary are being considered for both the reporting requirement therefore will Tribal Transit Programs? formula and discretionary programs. apply. b. Would an 80/20 match present a a. Common Grant Rule (49 CFR Part h. Bus Testing (49 CFR part 665) financial burden on tribes? If so, is there 18), ‘‘Uniform Administrative requirement. To ensure that vehicles a proposed match amount that would be Requirements for Grants and acquired under this program will meet less burdensome? Cooperative Agreements to State and adequate safety and operational c. Under SAFETEA–LU, FTA limited Local Governments.’’ This is a standards, should FTA now apply this the indirect cost to not more than 10 government-wide regulation that applies requirement? percent of each Tribal Transit grant to all Federal assistance programs. i. Labor Protection requirement. The award. Should FTA retain the condition b. Civil Rights Act of 1964. Unless U.S. Department of Labor (DOL) will, that indirect costs not exceed 10 percent Indian tribes are specifically exempted pursuant to 49 U.S.C. 5333(b), apply the of each Tribal Transit grant award under from civil rights statutes, compliance section 5311 special warranty. Congress MAP–21? with civil rights statutes will be amended section 5311(i) to apply required, including compliance with section 5333(b) ‘‘if the Secretary of V. Proposed Terms and Conditions of equity in service. Title VI of the Civil Labor utilizes a special warranty that the Tribal Transit Program Rights Act prohibits discrimination on provides a fair and equitable Section 5311(c) of Title 49 U.S.C., as the basis of race, color, and national arrangement to protect the interests of amended by MAP–21, provides that origin in programs and activities employees.’’ Congress did not exempt available funds shall be apportioned for receiving Federal financial assistance. the Tribal Transit Program from this grants to Indian tribes, ‘‘under such Title VII of the Civil Rights Act requirement. FTA therefore intends to terms and conditions as may be prohibits discrimination in employment continue to apply the special warranty established by the Secretary.’’ The term in any business on the basis of race, to the Tribal Transit Program. ‘‘Secretary’’ in this provision refers to color, religion, sex, or national origin. j. Buy America requirements. FTA did the Secretary of Transportation. The Indian tribes are specifically excluded not apply the Buy America Secretary of Transportation possesses from the definition of an ’’employer’’ requirements to the Tribal Transit the authority to limit the applicability of under the Act. Thus, to the extent that program prior to FY 2012. However, certain substantive and procedural Tribal Employment Rights Offices FTA proposes including Buy America requirements that are set forth in Title (TERO) are consistent with Federal requirements on the formula and 49 (Transportation) of the United States statutes that authorize a general discretionary programs under MAP–21. Code. This includes the Federal transit preference for Indians in employment or k. MAP–21, Section 5329 requires all assistance provisions in Chapter 53 contracting for federally funded work on grantees to develop comprehensive (Public Transportation) of Title 49, or around Indian reservations, FTA of agency safety management plans that at which are administered by FTA. The course will comply with applicable law. a minimum include methods for Secretary of Transportation, however, However, although Indian tribes will identifying and evaluating safety risks, does not possess the authority to limit not be subject to FTA’s program-specific strategies to minimize exposure to the applicability of government-wide requirements under Title VI and Title hazards and unsafe conditions, and grant requirements (commonly referred VII of the Civil Rights Act, Indian tribes performance targets for safety to as cross-cutting requirements) that under the Tribal Transit Program performance criteria and state of good apply to all Federal grants. Recipients of nonetheless still will be subject to the repairs standards established in a Federal assistance are subject to many provisions of Title VI and Title VII of forthcoming National Public requirements regardless of the source of the Civil Rights Act, unless they are Transportation Safety plan. A funds, for example, restrictions on specifically exempt from the Act. rulemaking is forthcoming to further lobbying. Recipients under the Tribal c. Section 504 of the Rehabilitation explain the requirements for the Transit Program are subject to these Act of 1973 and Americans with development and certification of agency government-wide grant requirements, Disabilities Act (ADA) requirements in safety plans and following that which are not all named in this 49 CFR parts 27, 37, and 38 are rulemaking, FTA will be finalizing document. In addition, some Federal government-wide requirements that requirements through a rulemaking at a requirements are applicable regardless apply to all Federal programs. later date. In the interim, we are seeking of whether Federal assistance is d. Drug and Alcohol Testing comment on whether to apply these provided. For example, the requirement requirements (49 CFR Part 655). Should provisions to the Tribal Transit for drivers of vehicles over a certain size FTA continue to apply this requirement Program. is to hold a Commercial Driver’s because it addresses a national safety l. Transit Asset Management License. issue for operators of public Provisions. MAP–21 requires each To the extent permitted by law and in transportation? recipient and subrecipient of FTA grants recognition of the unique status and e. National Environmental Policy Act. to establish a ‘‘transit asset autonomy of Indian tribes, FTA has This is a government-wide requirement management’’ (TAM) plan for its transit made every effort in establishing the that applies to all Federal programs. system. This requirement, however, terms and conditions to balance the f. Charter Service and School Bus would not be a condition for receiving objectives of this program, which will transportation requirements in 49 CFR FTA grants until FTA issues its rule- directly benefit transit projects for parts 604 and 605. The definition of making. Further, depending on the Indian tribes, with other national ‘‘public transportation’’ in 49 U.S.C. outcome of that rule-making, FTA objectives (e.g., safety) that are 5302 specifically excludes school bus would propose that so long as tribes important not only to Indian tribes but and charter service. have a system for maintaining their also to the general public. Other g. NTD Reporting requirement. 49 capital asset inventory and a basis for applicable program requirements were U.S.C. 5335 requires NTD reporting for prioritizing and replacing capital assets, established for the Tribal Transit all direct recipients of section 5311 it would not require the tribe to prepare Program under SAFETEA–LU. funds. The Tribal Transit Program is a a TAM plan. FTA seeks comment on Therefore, FTA seeks guidance on the section 5311 program that will provide whether to apply this requirement to the following terms and conditions, which funds directly to Indian tribes and this Tribal Transit Program.

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m. Pre-award and post-delivery audits Goshen Branch Between Firth & As a condition to this exemption, any (49 CFR part 633). FTA seeks comment Ammon, in Bingham & Bonneville employees affected by the acquisition of on whether to apply this requirement. Counties, Idaho, 360 I.C.C. 91 (1979). the temporary trackage rights will be n. Should U.S. DOT’s DBE regulation, This notice is filed under 49 CFR protected by the conditions imposed in 49 CFR part 26, continue not to apply 1180.2(d)(8). If it contains false or Norfolk & Western Railway—Trackage to the Tribal Transit Program? misleading information, the exemption Rights—Burlington Northern, Inc., 354 A comprehensive list and description of is void ab initio. Petitions to revoke the I.C.C. 605 (1978), as modified in all of the statutory and regulatory terms exemption under 49 U.S.C. 10502(d) Mendocino Coast Railway—Lease & and conditions that FTA applied to the may be filed at any time. The filing of Operate—California Western Railroad, SAFETEA–LU Tribal Transit Program a petition to revoke will not 360 I.C.C. 653 (1980), and any are set forth in FTA’s Master Agreement automatically stay the effectiveness of employees affected by the for the Tribal Transit Program available the exemption. Petitions for stay must discontinuance of those trackage rights on FTA’s Web site at: www.fta.dot.gov/. be filed no later than November 16, will be protected by the conditions set Annual certifications and assurances are 2012 (at least 7 days before the out in Oregon Short Line Railroad & The also available on FTA’s Web site. exemption becomes effective). Union Pacific Railroad—Abandonment Issued in Washington, DC, this 6th day of An original and 10 copies of all Portion Goshen Branch Between Firth & November, 2012. pleadings, referring to Docket No. FD Ammon, in Bingham & Bonneville Peter M. Rogoff, 35690, must be filed with the Surface Counties, Idaho, 360 I.C.C. 91 (1979). Administrator. Transportation Board, 395 E Street SW., This notice is filed under 49 CFR Washington, DC 20423–0001. In 1180.2(d)(8). If it contains false or [FR Doc. 2012–27458 Filed 11–8–12; 8:45 am] addition, a copy of each pleading must misleading information, the exemption BILLING CODE P be served on Roy J. Christensen, is void ab initio. Petitions to revoke the Johnson, Killen & Seiler, P.A., 230 W. exemption under 49 USC 10502(d) may DEPARTMENT OF TRANSPORTATION Superior Street, Suite 800, Duluth, MN be filed at any time. The filing of a 55802. petition to revoke will not automatically Surface Transportation Board Board decisions and notices are stay the transaction. Petitions for stay available on our Web site at must be filed no later than November [Docket No. FD 35690] www.stb.dot.gov. 16, 2012 (at least 7 days before the Northern Plains Railroad, Inc.— Decided: November 5, 2012. exemption becomes effective). An original and 10 copies of all Temporary Trackage Rights By the Board, Richard Armstrong, Acting Exemption—Soo Line Railroad Director, Office of Proceedings. pleadings, referring to Docket No. FD Company 35687, must be filed with the Surface Derrick A. Gardner, Transportation Board, 395 E Street SW., Soo Line Railroad Company (Soo Clearance Clerk. Washington, DC 20423–0001. In Line), pursuant to a written agreement [FR Doc. 2012–27535 Filed 11–8–12; 8:45 am] addition, a copy of each pleading must dated October 4, 2012, has agreed to BILLING CODE 4915–01–P be served on W. Karl Hansen, Leonard, grant temporary overhead trackage Street and Deinard, 150 South Fifth rights to Northern Plains Railroad, Inc. Street, Suite 2300, Minneapolis, MN (NPR) between milepost 128.9 at DEPARTMENT OF TRANSPORTATION 55402. Mahnomen, Minn., and milepost 153.6 Board decisions and notices are at Erskine, Minn., a distance of Surface Transportation Board available on our Web site at approximately 24.7 miles.1 [Docket No. FD 35687] www.stb.dot.gov. The transaction may be consummated Decided: November 1, 2012. on or after November 25, 2012, and the Soo Line Railroad Company— By the Board, Rachel D. Campbell, temporary trackage rights are scheduled Temporary Trackage Rights Director, Office of Proceedings. to expire on or about December 24, Exemption—BNSF Railway Company Jeffrey Herzig, 2012. The purpose of the temporary trackage rights is to permit NPR to BNSF Railway Company (BNSF), Clearance Clerk. operate bridge train service during pursuant to a written trackage rights [FR Doc. 2012–27412 Filed 11–8–12; 8:45 am] certain programmed track, roadbed and agreement (Agreement), has agreed to BILLING CODE 4915–01–P structural maintenance on trackage it grant temporary overhead trackage leases from Soo Line. rights to Soo Line Railroad Company d/ As a condition to this exemption, any b/a Canadian Pacific (Soo Line) over DEPARTMENT OF THE TREASURY employees affected by the trackage BNSF’s line of railroad between Ardoch, rights will be protected by the N.D., and Erskine, Minn., a distance of Alcohol and Tobacco Tax and Trade conditions imposed in Norfolk and approximately 84.6 miles. Bureau Western Railway—Trackage Rights— The transaction may be consummated on or after November 24, 2012, the Proposed Information Collections; Burlington Northern, Inc., 354 I.C.C. 605 Comment Request (1978), as modified in Mendocino Coast effective date of the exemption (30 days Railway—Lease and Operate— after the verified notice of exemption AGENCY: Alcohol and Tobacco Tax and California Western Railroad, 360 I.C.C. was filed). The temporary trackage Trade Bureau; Treasury. 653 (1980), and any employees affected rights are scheduled to expire on or ACTION: Notice and request for by the discontinuance of those trackage about December 24, 2012. The purpose comments. rights will be protected by the of the temporary trackage rights is to conditions set out in Oregon Short Line permit Soo Line to bridge its train SUMMARY: As part of our continuing Railroad—Abandonment Portion service while its main lines are out of effort to reduce paperwork and service due to certain programmed respondent burden, and as required by 1 In a letter filed on November 1, 2012, NPR track, roadbed, and structural the Paperwork Reduction Act of 1995, provided the specific mileposts. maintenance. we invite comments on the proposed or

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continuing information collections collection’s burden on respondents, use, which would reduce a qualifying listed below in this notice. including through the use of automated brewer’s reporting requirements from 12 DATES: We must receive your written collection techniques or other forms of times a year to just 4. We estimate these comments on or before January 8, 2013. information technology; and (e) changes will affect the estimated ADDRESSES: You may send comments to estimates of capital or start-up costs and number of respondents and estimated Mary A. Wood, Alcohol and Tobacco costs of operation, maintenance, and total annual burden. Tax and Trade Bureau, at any of these purchase of services to provide the For more information on these and addresses: requested information. additional minor proposed changes to these two forms, see the TTB • U.S. mail: 1310 G Street NW., Box Information Collections Open for announcement posted on the beer page 12, Washington, DC 20005; Comment • Hand delivery/courier in lieu of of the TTB Web site at http:// Currently, we are seeking comments mail: 1310 G Street NW., Suite 200E, www.ttb.gov/beer/index.shtml. on the following TTB forms and Washington, DC 20005; Type of Review: Revision of a • 202–453–2686 (facsimile); or recordkeeping requirements: currently approved collection. Title: Brewer’s Report of Operations • [email protected] (email). Affected Public: Business or other for- Please send separate comments for and Brewpub Report of Operations. profit. OMB Control Number: 1513–0007. Estimated Number of Respondents: each specific information collection TTB Form Numbers: 5130.9 and listed below. You must reference the 2,026. 5130.26. Estimated Total Annual Burden information collection’s title, form or Abstract: The Internal Revenue Code Hours: 9,114. recordkeeping requirement number, and (IRC) requires brewers to file periodic OMB number (if any) in your comment. reports of their brewing and associated Title: Application to Establish and If you submit your comment via operations. TTB uses these reports to Operate Wine Premises and Wine Bond. facsimile, please send no more than five OMB Control Number: 1513–0009. × determine whether the brewer’s 8.5 11 inch pages in order to ensure operations are in compliance with the TTB Form Numbers: 5120.25 and our equipment is not overburdened. requirements of Federal law and 5120.36, respectively. FOR FURTHER INFORMATION CONTACT: To regulations. We also use this Abstract: TTB F 5120.25, Application obtain additional information, copies of information to assist us in determining to Establish and Operate Wine Premises, the information collection and its whether the brewer pays the proper is the form used to establish the instructions, or copies of any comments Federal excise taxes in a timely and qualifications of a person applying to received, contact Mary A. Wood, accurate manner. establish and operate a wine premises. Alcohol and Tobacco Tax and Trade Current Actions: We are submitting The applicant certifies their intention to Bureau, 1310 G Street NW., Box 12, this information collection as a revision. produce and/or store a specified amount Washington, DC 20005; or telephone TTB is revising TTB F 5130.9, Brewers of wine and to take certain precautions 202–453–2265. Report of Operations and TTB F to protect it from unauthorized use. TTB SUPPLEMENTARY INFORMATION: 5130.26, Brewpub Report of Operations. F 5120.36, Wine Bond, is the form used We are revising these forms primarily to by the proprietor and a surety company Request for Comments ease the regulatory burden on brewers, as a contract to ensure the payment of The Department of the Treasury and particularly small brewers, without the Federal wine excise tax. its Alcohol and Tobacco Tax and Trade compromising our mandates under the Current Actions: We are submitting Bureau (TTB), as part of their Internal Revenue Code of 1986. On both this information collection for extension continuing effort to reduce paperwork forms, TTB proposes to remove two purposes only. The information and respondent burden, invite the parts, ‘‘Part 2–Report Period Tax collection, estimated number of general public and other Federal Payments’’ and ‘‘Part 3–Summary of respondents, and estimated total annual agencies to comment on the proposed or Materials Used and Wort Produced’’ and burden hours remain unchanged. continuing information collections to add directions for filing electronically Type of Review: Extension of a listed below in this notice, as required through the ‘‘Pay.gov’’ system to the currently approved collection. by the Paperwork Reduction Act of 1995 Instructions section. Affected Public: Business or other for- (44 U.S.C. 3501 et seq.). TTB also proposes to make additional profit. Comments submitted in response to changes to TTB F 5130.26 so that it is Estimated Number of Respondents: this notice will be included or applicable to a majority of small 1,720. summarized in our request for Office of brewers. For example, this quarterly Estimated Total Annual Burden Management and Budget (OMB) form, which is considerably less Hours: 2,050. approval of the relevant information detailed than TTB F 5130.9, is currently Title: Formula and/or Process for collection. All comments are part of the restricted to brewpubs who remove Article Made With Specially Denatured public record and subject to disclosure. 5,000 barrels or less per calendar year Spirits. Please do not include any confidential and who do not bottle. The proposed OMB Control Number: 1513–0011. or inappropriate material in your changes to TTB F 5130.26 provide that TTB Form Number: 5150.19. comments. all brewers producing less than 10,000 Abstract: TTB F 5150.19 is completed We invite comments on: (a) Whether barrels per calendar year may use this by persons who use specially denatured this information collection is necessary form to report quarterly, and, as a result, spirits in the manufacture of certain for the proper performance of the we propose to change the name of this articles. TTB uses the information agency’s functions, including whether form from ‘‘Brewpub Report of provided on the form to ensure the the information has practical utility; (b) Operations’’ to ‘‘Small Brewers Report.’’ manufacturing formulas and processes the accuracy of the agency’s estimate of We estimate these changes will conform to statutory requirements (see the information collection’s burden; (c) reduce the time it takes brewers to 26 U.S.C. 5273). ways to enhance the quality, utility, and complete either form by 15 minutes. We Current Actions: We are submitting clarity of the information collected; (d) also believe that the changes to TTB F this information collection as a revision. ways to minimize the information 5130.26 will significantly increase its The information collection and

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estimated number of respondents regulatory section numbers as recodified Title: Application to Receive Spirits remain unchanged. However, the in the final rule for the revision of 27 and/or Denatured Spirits by Transfer in burden hours decreased slightly because CFR Part 19, Distilled Spirits Plants. Bond. this form is included in our Formulas Type of Review: Revision of a OMB Control Number: 1513–0038. Online (FONL) system which allows it currently approved collection. TTB Form Number: 5100.16. to be submitted electronically. It takes Affected Public: Business or other for- Abstract: TTB F 5100.16 is completed less time to complete the form using profit. by distilled spirits plant proprietors FONL. Estimated Number of Respondents: who wish to receive spirits in bond from Type of Review: Revision of a 5,000. other distilled spirits plants. TTB uses currently approved collection. Estimated Total Annual Burden the information to determine if the Affected Public: Business or other for- Hours: 3,250. applicant has sufficient bond coverage profit. Title: Report—Proprietor of Export for the additional tax liability assumed Estimated Number of Respondents: Warehouse. when spirits are received through a 2,683. OMB Control Number: 1513–0024. transfer in bond. Estimated Total Annual Burden TTB Form Number: 5220.4. Current Actions: We are submitting Hours: 2,415. Abstract: Proprietors account for this information collection as a revision. Title: User’s Report of Denatured taxable articles on this report. TTB uses The burden hours decrease slightly Spirits. this information to ensure that because this form is included in our OMB Number: 1513–0012. proprietors have complied with Federal Permits Online system which allows it TTB Form Number: 5150.18. laws and regulations and to protect to be submitted electronically. It takes Abstract: Submitted annually by against diversion. less time to complete this form holders of permits to use specially Current Actions: We are submitting electronically. Also, the supporting denatured spirits, TTB F 5150.18 this information collection as a revision. statement and form reflects changes to summarizes the permittee’s We are updating this collection as a regulatory section numbers as recodified manufacturing activities during the result of changes made to the form as a in the final rule for the revision of 27 preceding year. The information is used result of the regulations implementing CFR Part 19, Distilled Spirits Plants (see by TTB to pinpoint unusual activities the Children’s Health Insurance T.D. TTB–92, published in the Federal that could indicate a threat to the Program Reauthorization Act of 2009 Register on February 16, 2011, at 76 FR Federal revenue or possible dangers to (see T.D. TTB–104, published in the 9080). the public. Federal Register of June 21, 2012, at 77 Type of Review: Revision of a Current Actions: We are submitting FR 37287). The estimated number of currently approved collection. Affected Public: Business or other for- this information collection for extension respondents and estimated total annual profit. purposes only. The information burden hours remain unchanged. Estimated Number of Respondents: collection, estimated number of Type of Review: Revision of a 1,508. respondents, and estimated total annual currently approved collection. Estimated Total Annual Burden burden hours remain unchanged. Affected Public: Business or other for- Hours: 302. Type of Review: Extension of a profit. currently approved collection. Estimated Number of Respondents: Title: Distilled Spirits Plants Affected Public: Business or other for- 80. Warehousing Record, and Monthly profit. Estimated Total Annual Burden Report of Storage Operations. OMB Control Number: 1513–0039. Estimated Number of Respondents: Hours: 1,920. TTB Form Number: 5110.11. 3,778. Title: Certificate of Tax TTB Recordkeeping Number: 5110/02. Estimated Total Annual Burden Determination—Wine. Abstract: TTB uses this information Hours: 1,133. OMB Control Number: 1513–0029. collection to account for a proprietor’s Title: Power of Attorney. TTB Recordkeeping Number: 5120.20. tax liability and adequacy of bond OMB Number: 1513–0014. Abstract: Wine that has been coverage, and to protect the revenue. TTB Form Number: 5000.8. manufactured, produced, bottled, or The information also provides data to Abstract: TTB F 5000.8 delegates the packaged in bulk containers in the U.S. analyze trends, audit operations, authority to a specific individual to sign and then exported is eligible for a monitor industry activities and documents on behalf of an applicant or drawback (refund) of the excise tax paid compliance in order to provide for a principal. The Internal Revenue Code on that wine. TTB F 5120.20 supports efficient allocation of field personnel, at 26 U.S.C. 6061 authorizes our the exporter’s claim for drawback, as the and provide for economic analysis. regulations requiring that an individual producing winery verifies that the wine Current Actions: We are submitting signing returns, statements, or other being exported was in fact exported. this information collection as a revision. required documents filed by industry Current Actions: We are submitting The supporting statement and form members under the provisions of the this information collection for extension reflects changes to regulatory section Code or the Federal Alcohol purposes only. The information numbers as recodified in the final rule Administration Act have that signature collection, estimated number of for the revision of 27 CFR Part 19, authority on file with TTB. respondents, and estimated total annual Distilled Spirits Plants. The estimated Current Actions: We are submitting burden hours remain unchanged. number of respondents and estimated this information collection as a revision. Type of Review: Extension of a total annual burden hours remain The burden hours decrease slightly currently approved collection. unchanged. because this form is included in our Affected Public: Business or other for- Type of Review: Revision of a Permits Online system which allows it profit. currently approved collection. to be submitted electronically. It takes Estimated Number of Respondents: Affected Public: Business or other for less time to complete this form 1,000. profit. electronically. Also, the supporting Estimated Total Annual Burden Estimated Number of Respondents: statement and form reflects changes to Hours: 500. 230.

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Estimated Total Annual Burden Title: Distilled Spirits Plant (DSP) Applications control the authorized Hours: 5,520. Denaturation Records, and Monthly uses and flow of tax-free alcohol. TTB Title: Distilled Spirits Plants—Excise Report of Processing (Denaturing) Letterhead Applications and Notices are Taxes. Operations. designed to protect tax revenue and OMB Control Number: 1513–0045. OMB Control Number: 1513–0049. public safety. TTB Recordkeeping Number: 5110/06. TTB Form Number: 5110.43. Current Actions: We are submitting Abstract: The collection of TTB Recordkeeping Number: 5110/04. this information collection for extension information is necessary to account for Abstract: This information collection purposes only. The information and verify taxable removals of distilled is necessary to account for and verify collection, estimated number of spirits. The data is used to audit tax the denaturation of distilled spirits. It is respondents, and estimated total annual payments. used to audit plant operations, monitor burden hours remain unchanged. Current Actions: We are submitting the industry for the efficient allocation Type of Review: Extension of a this information collection as a revision. of personnel resources, and compile currently approved collection. The supporting statement reflects statistics for government economic Affected Public: Not-for-profit changes to regulatory section numbers planning. institutions; Federal Government; State, as recodified in the final rule for the Current Actions: We are submitting local, or tribal government. revision of 27 CFR Part 19, Distilled this information collection as a revision. Estimated Number of Respondents: Spirits Plants (see T.D. TTB–92, The supporting statement and form 4,444. published in the Federal Register on reflect changes to regulatory section Estimated Total Annual Burden February 16, 2011, at 76 FR 9080). The numbers as recodified in the final rule Hours: 2,222. estimated number of respondents and for the revision of 27 CFR Part 19, Title: Stills—Retail Liquor Dealers estimated total annual burden hours Distilled Spirits Plants. The estimated Records of Receipts of Alcoholic remain unchanged. number of respondents and estimated Beverages and Commercial Invoices. Type of Review: Revision of a total annual burden hours remain OMB Number: 1513–0066. currently approved collection. unchanged. TTB Recordkeeping Number: 5170/3. Affected Public: Business or other for- Type of Review: Revision of a Abstract: The primary objective of profit. currently approved collection. this recordkeeping requirement is Estimated Number of Respondents: Affected Public: Business or other for- revenue protection, by making 133. profit. accountability data available for audit Estimated Total Annual Burden Estimated Number of Respondents: purposes. Another objective is Hours: 3,458. 98. consumer protection, by affording the Title: Formula for Distilled Spirits Estimated Total Annual Burden subject record traceability of alcoholic under the Federal Alcohol Hours: 1,176. beverages to the retail liquor dealer level Administration Act. Title: Distilled Spirits Plants— of distribution in the event of defective OMB Control Number: 1513–0046. Transaction and Supporting Records. products. The record retention TTB Form Number: 5110.38. OMB Control Number: 1513–0056. requirement for this information Abstract: TTB F 5110.38 is used to TTB Recordkeeping Number: 5110/5. collection is three years. determine the classification of distilled Abstract: Transaction records provide Current Actions: We are submitting spirits for labeling and for consumer the source data for accounts of distilled this information collection for extension protection purposes. The form describes spirits in all DSP operations. They are purposes only. The information the person filing, type of product to be used by TTB to verify those accounts collection, estimated number of made, and restrictions to the label and/ and consequent tax liabilities. respondents, and estimated total annual or manufacturing process. The form is Current Actions: We are submitting burden hours remain unchanged. used by TTB to ensure that a product is this information collection as a revision. Type of Review: Extension of a made and labeled properly, and to audit The supporting statement reflects currently approved collection. distilled spirits operations. Records are changes to regulatory section numbers Affected Public: Business or other for kept indefinitely for this information as recodified in the final rule for the profit; State, local, or tribal government. collection. revision of 27 CFR Part 19, Distilled Estimated Number of Respondents: Current Actions: We are submitting Spirits Plants. The estimated number of 455,000. this information collection as a revision. respondents and estimated total annual Estimated Total Annual Burden The supporting statement and form burden hours remain unchanged. Hours: 455,000. reflect changes to regulatory section Type of Review: Revision of a Title: Wholesale Dealers Applications, numbers as recodified in the final rule currently approved collection. Letterheads, and Notices Relating to for the revision of 27 CFR Part 19, Affected Public: Business or other for- Operations. (Variations in Format or Distilled Spirits Plants (see T.D. TTB– profit. Preparation of Records). 92, published in the Federal Register on Estimated Number of Respondents: OMB Control Number: 1513–0067. February 16, 2011, at 76 FR 9080). The 278. TTB Recordkeeping Number: 5170/6. estimated number of respondents and Estimated Total Annual Burden Abstract: This recordkeeping estimated total annual burden hours Hours: 6,060. requirement pertains only to those remain unchanged. Title: Letterhead Applications and wholesale liquor and beer dealers Type of Review: Revision of a Notices Relating to Tax-Free Alcohol. submitting applications for a variance currently approved collection. OMB Number: 1513–0060. from the regulations dealing with Affected Public: Business or other for- TTB Recordkeeping Number: 5150/4. preparation, format, type, or place of profit. Abstract: Tax-free alcohol is used for retention of records of receipt or Estimated Number of Respondents: nonbeverage purposes by educational disposition of alcoholic beverages. 200. organizations, hospitals, laboratories, Current Actions: We are submitting Estimated Total Annual Burden and the like in scientific research and this information collection for extension Hours: 4,000. for medicinal purposes. Permits/ purposes only. The information

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collection, estimated number of Affected Public: Business or other for- Title: Applications, Notices, and respondents, and estimated total annual profit. Permits Relating to Importation and burden hours remain unchanged. Estimated Number of Respondents: Exportation of Distilled Spirits, Wine Type of Review: Extension of a 500. and Beer, Including Puerto Rico and currently approved collection. Estimated Total Annual Burden Virgin Islands. Affected Public: Business or other for- Hours: 200. OMB Control Number: 1513–0100. profit. Title: Labeling of Sulfites in Alcoholic TTB Form/Recordkeeping Number: Estimated Number of Respondents: Beverages. None. 1,029. OMB Control Number: 1513–0084. Abstract: Distilled spirits, beer, wine, Estimated Total Annual Burden TTB Form/Recordkeeping Number: and industrial alcohol are subject to Hours: 515. None. Federal alcohol excise tax when Title: Equipment and Structures. Abstract: As mandated by Federal imported into the United States. The OMB Control Number: 1513–0080. law, and in accordance with our taxes on these commodities coming TTB Recordkeeping Number: 5110/12. consumer protection responsibilities, from the Virgin Islands and Puerto Rico Abstract: Marks, signs, and TTB requires label disclosure statements are largely returned to the two insular calibrations are necessary on equipment on all alcoholic beverage products governments. Exports of these products and structures at a distilled spirits plant released from U.S. bottling premises or from the United States are largely tax in order to identify the plant’s major customs custody that contain 10 parts free. These documents ensure that the equipment and to accurately determine per million or more of sulfites. Sulfating proper taxes are collected or returned the plant’s contents. agents have been shown to produce according to law. Current Actions: We are submitting allergic-type responses in humans, Current Actions: We are submitting this information collection as a revision. particularly asthmatics, and the this information collection for extension The supporting statement reflects presence of these ingredients in alcohol purposes only. The information changes to regulatory section numbers beverages may have serious health collection, estimated number of as recodified in the final rule for the implications for those who are respondents, and estimated total annual revision of 27 CFR Part 19, Distilled intolerant of sulfites. Disclosure of burden hours remain unchanged. Spirits Plants. The estimated number of sulfites on labels of alcohol beverages Type of Review: Extension of a respondents and estimated total annual will minimize their exposure to these currently approved collection. burden hours remain unchanged. ingredients. Affected Public: Business or other for- Type of Review: Revision of a Current Actions: We are submitting profit. currently approved collection. this information collection as a revision. Estimated Number of Respondents: Affected Public: Business or other for- We updated the estimated number of 20. profit. respondents and estimated total annual Estimated Total Annual Burden Estimated Number of Respondents: burden hours. Hours: 180. 281. Type of Review: Revision of a Title: Information Collected in Estimated Total Annual Burden currently approved collection. Support of Small Producer’s Wine Tax Hours: One (1). Estimated Number of Respondents: Credit. Title: Alternative Methods or 18,163. OMB Control Number: 1513–0104. Procedures and Emergency Variations Estimated Total Annual Burden TTB Recordkeeping Number: 5120/11. from Requirements for Exports of Hours: 12,109. Abstract: TTB is responsible for the Liquors. Title: Notices Relating to Payment of collection of the Federal excise tax on OMB Control Number: 1513–0082. Firearms and Ammunition Excise Tax. wines. Certain small wine producers are TTB Recordkeeping Number: 5170/7. OMB Control Number: 1513–0097. eligible for a credit which may be taken Abstract: When an exporter seeks to TTB Form/Recordkeeping Number: to reduce the tax they pay on wines use an alternate method or procedure or None. removed from their own premises. In seeks an emergency variation from the Abstract: Federal excise taxes are addition, small producers can authorize regulatory requirements of 27 CFR part collected on the sale or use of firearms bonded warehouses, which store their 28, such exporter requests a variance by and ammunition by firearms or wine and ship it on their instructions, letter, following the procedure in 27 ammunition manufacturers, importers, to take the credit on their behalf. The CFR 28.20. TTB uses the provided or producers. Taxpayers who elect to transferee will use the information information to determine if the pay excise taxes by electronic fund provided by the small producer under requested variance is allowed by statute transfer must furnish a written notice the regulations to take the appropriate and does not jeopardize the revenue. upon election and discontinuance. This credit on behalf of the small producer, The applicant is informed of the notice protects the tax revenue. and the producer will use this approval or disapproval of the request. Current Actions: We are submitting information to monitor its own tax TTB also uses the information to this information collection for extension payments to ensure it does not exceed analyze what changes should be made purposes only. The information the authorized annual credit. The to existing regulations. Records will be collection, estimated number of information is used by taxpayers in maintained only while the applicant is respondents, and estimated total annual preparing their returns and by TTB to using the authorization. burden hours remain unchanged. verify tax computation. Current Actions: We are submitting Type of Review: Extension of a Current Actions: We are submitting this information collection for extension currently approved collection. this information collection for extension purposes only. The information Affected Public: Business or other for- purposes only. The information collection, estimated number of profit. collection, estimated number of respondents, and estimated total annual Estimated Number of Respondents: respondents, and estimated total annual burden hours remain unchanged. 10. burden hours remain unchanged. Type of Review: Extension of a Estimated Total Annual Burden Type of Review: Extension of a currently approved collection. Hours: One (1). currently approved collection.

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Affected Public: Business or other for- Estimated Total Annual Burden Dated: November 6, 2012. profit. Hours: 2,800. Amy R. Greenberg, Estimated Number of Respondents: Assistant Director, Regulations and Rulings 280. Division. [FR Doc. 2012–27464 Filed 11–8–12; 8:45 am] BILLING CODE 4810–31–P

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Part II

Department of Health and Human Services

Centers for Medicare & Medicaid Services 42 CFR Parts 413 and 417 Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Bad Debt Reductions for All Medicare Providers; Final Rule

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DEPARTMENT OF HEALTH AND I. Executive Summary 3. Use of AY Modifier HUMAN SERVICES A. Purpose E. Miscellaneous Comments 1. End-Stage Renal Disease (ESRD) III. End-Stage Renal Disease (ESRD) Quality Centers for Medicare & Medicaid Prospective Payment System (PPS) Incentive Program (QIP) for Payment Services 2. ESRD QIP Year (PY) 2015 3. Reductions to Bad Debt Payments for All A. Background Medicare Providers and Elimination of B. Summary of the Proposed Provisions 42 CFR Parts 413 and 417 the Cap on Bad Debt Reimbursement to and Responses to Comments on the [CMS–1352–F] ESRD Facilities ESRD QIP for PY 2015 B. Summary of Major Provisions C. Considerations in Updating and RIN 0938–AR13 1. ESRD PPS Expanding Quality Measures Under the 2. ESRD QIP ESRD QIP for PY 2015 and Subsequent Medicare Program; End-Stage Renal 3. Reductions to Bad Debt Payments for All PYs Disease Prospective Payment System, Medicare Providers and Elimination of 1. Value-Based Purchasing (VBP) Overview Quality Incentive Program, and Bad the Cap on Bad Debt Reimbursement to 2. Brief Overview of Proposals Debt Reductions for All Medicare ESRD Facilities 3. Measures Application Partnership Providers C. Summary of Cost and Benefits Review 1. Impacts of the Final ESRD PPS 4. PY 2014 Mineral Metabolism Measure AGENCY: Centers for Medicare & 2. ESRD QIP D. Proposed Measures for the PY 2015 Medicaid Services (CMS), HHS. 3. Impacts of Bad Debt Provisions ESRD QIP and Subsequent PYs of the II. Calendar Year (CY) 2013 End-Stage Renal ESRD QIP ACTION: Final rule. Disease (ESRD) Prospective Payment 1. PY 2014 Measures Continuing for PY SUMMARY: This final rule updates and System (PPS) 2015 and Subsequent PYs A. Background on the End-Stage Renal a. Hemoglobin Greater Than 12 g/dL makes revisions to the end-stage renal Disease (ESRD) Prospective Payment b. Vascular Access Type (VAT) Measure disease (ESRD) prospective payment System (PPS) Topic system (PPS) for calendar year (CY) B. Summary of the Proposed Provisions c. In-Center Hemodialysis Consumer 2013. This rule also sets forth and Responses to Comments on the CY Assessment of Healthcare Providers and requirements for the ESRD quality 2013 ESRD PPS Systems (ICH CAHPS) incentive program (QIP), including for C. Routine Updates and Proposed Policy 2. Expansion of Two PY 2014 Measures for payment year (PY) 2015 and beyond. In Changes to the CY 2013 ESRD PPS PY 2015 and Subsequent PYs addition, this rule implements changes 1. Composite Rate Portion of the ESRD PPS a. Expanded National Healthcare Safety to bad debt reimbursement for all Blended Payment Network (NHSN) Dialysis Event a. Update to the Drug Add-on to the Reporting Measure Medicare providers, suppliers, and Composite Rate Portion of the ESRD b. Expanded Mineral Metabolism other entities eligible to receive Blended Payment Rate Reporting Measure Medicare payment for bad debt and i. Estimating Growth in Expenditures for 3. New Measures for PY 2015 and removes the cap on bad debt Drugs and Biologicals in CY 2013 Subsequent PYs of the ESRD QIP reimbursement to ESRD facilities. (See ii. Estimating Per Patient Growth a. Kt/V Dialysis Adequacy Measure Topic the Table of Contents for a listing of the iii. Applying the Growth Update to the i. Adult Hemodialysis Adequacy specific issues addressed in this final Drug Add-On Adjustment ii. Peritoneal Dialysis Adequacy rule.) iv. Update to the Drug Add-On Adjustment iii. Pediatric, In-center Hemodialysis for CY 2013 Adequacy DATES: Effective Date: These regulations 2. ESRD PPS Base Rate b. Hypercalcemia are effective on January 1, 2013. 3. ESRD Bundled Market Basket c. Anemia Management Reporting Measure Applicability Date: The regulations a. Overview and Background 4. Measures Under Consideration for setting forth the reductions in Medicare b. Market Basket Update Increase Factor Future PYs of the ESRD QIP bad debt pursuant to section 3201 of the and Labor-Related Share for ESRD a. Standardized Hospitalization Ratio Middle Class Tax Extension and Job Facilities for CY 2013 (SHR) Creation Act of 2012 (Pub. L. 112–96) c. Productivity Adjustment b. Standardized Mortality Ratio (SMR) are applicable for cost reporting periods d. Calculation of the ESRDB Market Basket c. Public Reporting of SHR and SMR Update Adjusted for Multifactor Measures beginning October 1, 2012. Productivity for CY 2013 5. Other Potential Future Measures Under FOR FURTHER INFORMATION CONTACT: 4. Transition Budget-Neutrality Development Michelle Cruse, (410) 786–4533, for Adjustment for CY 2013 a. Thirty-Day Hospital Readmissions issues related to ESRD. 5. Updates to the Wage Index Values and b. Efficiency Heidi Oumarou, (410) 786–7942, for Wage Index Floor for the Composite Rate c. Population/Community Health issues related to the ESRD market Portion of the Blended Payment and the 6. Scoring Background and General basket. ESRD PPS Payment Considerations for the PY 2015 ESRD Anita Segar, (410) 786–4614, for a. Reduction to the ESRD Wage Index Floor QIP issues related to the QIP. b. Policies for Areas With No Wage Data 7. Performance Period for the PY 2015 Kellie Shannon, (410) 786–0416 for c. Wage Index Budget-Neutrality ESRD QIP Adjustment 8. Performance Standards for the PY 2015 information regarding Medicare bad d. ESRD PPS Wage Index Tables ESRD QIP debt. 6. Drug Policy Changes a. Clinical Measure Performance Standards SUPPLEMENTARY INFORMATION: a. Daptomycin b. Performance Standards b. Alteplase and Other Thrombolytics c. Performance Standards for the PY 2015 Table of Contents c. Part B Drug Pricing Reporting Measures To assist readers in referencing 7. Revisions to the Outlier Policy 9. Scoring for the PY 2015 ESRD QIP sections contained in this preamble, we a. Impact of Changes to the Outlier Policy Measures b. Outlier Policy Percentage a. Scoring Facility Performance on Clinical are providing a Table of Contents. Some D. Clarifications Regarding the ESRD PPS Measures Based on Achievement of the issues discussed in this preamble 1. Reporting Composite Rate Items and b. Scoring Facility Performance on Clinical affect the payment policies, but do not Services Measures Based on Improvement require changes to the regulations in the 2. ESRD Facility Responsibilities for ESRD- c. Calculating the Reporting Measure Code of Federal Regulations (CFR). Related Drugs and Biologicals Scores

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10. Weighting the PY 2015 ESRD QIP 3. Reductions to Bad Debt Payments for All LDO Large Dialysis Organization Measures and Calculation of the PY 2015 Medicare Providers MAP Medicare Allowable Payment ESRD QIP Total Performance Score C. Accounting Statement MCP Monthly Capitation Payment a. Weighting Individual Measures To VII. Regulatory Flexibility Act Analysis MIPPA Medicare Improvements for Patients Compute Measure Topic Scores for the VIII. Unfunded Mandates Reform Act and Providers Act of 2008 (Pub. L. 110– Kt/V Dialysis Adequacy Measure Topic Analysis 275) and the Vascular Access Type Measure IX. Federalism Analysis MMA Medicare Prescription Drug, Topic X. Files Available to the Public via the Improvement and Modernization Act of b. Weighting the Total Performance Score Internet 2003 c. Examples of the PY 2015 ESRD QIP Regulations Text MMEA Medicare and Medicaid Extenders Scoring Methodology Act of 2010 Pub. L. 111–309 11. Minimum Data for Scoring Measures Acronyms MFP Multifactor Productivity for the PY 2015 ESRD QIP Because of the many terms to which NHSN National Healthcare Safety Network a. Minimum Data for Scoring Clinical we refer by acronym in this final rule, NQF National Quality Forum Measures for the PY 2015 ESRD QIP we are listing the acronyms used and PD Peritoneal Dialysis b. Minimum Data Requirements for PFS Physician Fee Schedule Reporting Measures by New Facilities their corresponding meanings in PPS Prospective Payment System 12. Payment Reductions for the PY 2015 alphabetical order below: PSR Performance Score Report ESRD QIP AMCC Automated Multi-Channel PY Payment Year 13. Data Validation Chemistry QIP Quality Incentive Program 14. Scoring Facilities Whose Ownership ASP Average Sales Price REMIS Renal Management Information has Changed AV Arteriovenous System 15. Public Reporting Requirements BLS Bureau of Labor Statistics RFA Regulatory Flexibility Act IV. Limitation on Payments to All Providers, BMI Body Mass Index RHC Rural Health Clinic Suppliers and Other Entities Entitled to BSA Body Surface Area RRF Residual Renal Function Bad Debt CAH Critical Access Hospital RUL Reasonable Useful Lifetime A. Background CBSA Core-Based Statistical Area SBA Small Business Administration B. Section 3201 of The Middle Class Tax CCN CMS Certification Number SHR Standardized Hospitalization Ratio Extension and Job Creation Act of 2012 CDC Centers for Disease Control and SIMS Standard Information Management (Pub. L. No. 112–96) Prevention System C. Summary of Provisions of This Final CLABSI Central Line Access Bloodstream SMR Standardized Mortality Ratio Rule Infections SNF Skilled Nursing Facility 1. Section 3201 of The Middle Class Tax CFR Code of Federal Regulations SSA Social Security Administration Extension and Job Creation Act of 2012 CIP Core Indicators Project TEP Technical Expert Panel (Pub. L. No. 112–96) CMHC Community Mental Health Center The Act Social Security Act 2. ESRD Bad Debt Cap and Remove and CMP Competitive Medical Plans The Affordable Care Act The Patient Reserve § 413.178 CMS Centers for Medicare & Medicaid Protection and Affordable Care Act 3. Technical Corrections Services URR Urea Reduction Ratio D. Changes to Medicare Bad Debt Policy CPM Clinical Performance Measure VAT Vascular Access Type 1. Changes to 42 CFR 413.89(h) CPT Current Procedural Terminology VBP Value Based Purchasing 2. Rationale for Removing 42 CFR 413.178 CROWNWeb Consolidated Renal 3. Technical Corrections to 42 CFR Operations in a Web-Enabled Network I. Executive Summary 417.536(f)(1) CY Calendar Year A. Purpose V. Collection of Information Requirements DFC Dialysis Facility Compare A. Legislative Requirement for Solicitation DFR Dialysis Facility Report 1. End-Stage Renal Disease (ESRD) of Comments DME Durable Medical Equipment Prospective Payment System (PPS) B. Requirements in the Regulation Text ESA Erythropoiesis stimulating agent C. Additional Information Collection ESRD End-Stage Renal Disease This final rule updates and makes Requirements ESRDB End-Stage Renal Disease Bundled revisions to the End-Stage Renal Disease 1. ESRD QIP FDA Food and Drug Administration (ESRD) prospective payment system a. Display of Certificates for the PY 2015 FI/MAC Fiscal Intermediary/Medicare (PPS) for calendar year (CY) 2013. In ESRD QIP Administrative Contractor accordance with section 1881(b)(14) of b. NHSN Dialysis Event Reporting FQHC Federally Qualified Health Center the Social Security Act (the Act), as Requirement for the PY 2015 ESRD QIP FY Fiscal Year c. ICH CAHPS Survey Attestation GDP Gross Domestic Product added by section 153(b) of the Medicare Requirement for the PY 2015 ESRD QIP HAI Healthcare-associated Infections Improvements for Patients and d. Data Validation Requirements HCPCS Healthcare Common Procedure Providers Act of 2008 (MIPPA) (Pub. L. 2. Reductions to Bad Debt Payments for All Coding System 110–275), the Centers for Medicare & Medicare Providers HCPP Health Care Prepayment Plan Medicaid Services (CMS) implemented VI. Economic Analyses HD Hemodialysis a case-mix adjusted bundled PPS for A. Regulatory Impact Analysis HHD Home Hemodialysis Medicare outpatient ESRD dialysis 1. Introduction HMO Health Maintenance Organization services beginning January 1, 2011. The 2. Statement of Need ICD–9–CM International Classification of 3. Overall Impact Diseases, 9th Edition, Clinical ESRD PPS replaced the basic case-mix B. Detailed Economic Analysis Modifications adjusted composite payment system and 1. CY 2013 End-Stage Renal Disease ICH CAHPS In-Center Hemodialysis the methodologies for the (ESRD) Prospective Payment System Consumer Assessment of Healthcare reimbursement of separately billable (PPS) Providers and Systems outpatient ESRD services. a. Effects on ESRD Facilities IGI IHS Global Insight Also, section 1881(b)(14)(F) of the b. Effects on Other Providers IPPS Inpatient Prospective Payment System Act, as added by section 153(b) of c. Effects on the Medicare Program KDIGO Kidney Disease: Improving Global MIPPA and amended by section 3401(h) d. Effects on Medicare Beneficiaries Outcomes of the Affordable Care Act (Pub. L. 111– e. Alternatives Considered KDOQI Kidney Disease Outcome Quality 2. ESRD QIP Initiative 148), established that beginning CY a. Effects of the PY 2015 ESRD QIP Kt/V A measure of dialysis adequacy where 2012, and each subsequent year, the b. Alternatives Considered for the PY 2015 K is dialyzer clearance, t is dialysis time, Secretary shall reduce the market basket ESRD QIP and V is total body water volume increase factor by a productivity

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adjustment described in section (ASP) drug expenditure data and other 2013, we are reducing the wage index 1886(b)(3)(B)(xi)(II) of the Act. In data, we estimate a 2.9 percent decrease floor from 0.550 to 0.500. We also addition, the application of the in aggregate drug expenditures and a 4.0 applied the wage index budget- productivity adjustment may result in percent increase in enrollment. Using neutrality adjustment factor to the wage the increase factor being less than 0.0 these estimates, we project a 6.6 percent index floor of 0.500, which results in an percent for a year. decrease in per patient growth of drug adjusted wage index floor of 0.501 expenditures for CY 2013. Thus, we are × 2. End-Stage Renal Disease (ESRD) (0.500 1.001141) for CY 2013. projecting that the combined growth in • Quality Incentive Program (QIP) per patient utilization and pricing for Update to the outlier policy: We are This final rule also sets forth CY 2013 will result in a decrease to the updating the outlier services fixed requirements for the ESRD quality drug add-on equal to 0.9 percentage dollar loss amounts and Medicare incentive program (QIP), including for points. We will apply a zero update to Allowable Payments (MAPs) for CY payment year (PY) 2015. The program is the drug add-on adjustment and 2013 using 2011 data. Based on the use authorized under section 153(c) of maintain the $20.33 per treatment drug of more current data, the fixed dollar MIPPA, which added section 1881(h) to add-on amount for CY 2013. Because loss amount for pediatric patients will the Social Security Act (the Act). The the market basket minus productivity decrease from $71.64 to $47.32 and the ESRD QIP is the most recent step in that is applied to the composite rate MAP amount will decrease from $45.44 fostering improved patient outcomes by increases the composite rate, the add-on to $41.39 as compared to CY 2012 establishing incentives for dialysis adjustment of 14.3 percent is reduced to values. For adult patients, the fixed- facilities to meet performance standards 14.0 percent to maintain the drug add- dollar loss amount drops from $141.21 established by CMS. on at $20.33. to $110.22 and the MAP amount drops • Market basket and productivity from $78.00 to $59.42. Because of the 3. Reductions to Bad Debt Payments for adjustment: Under section decline in utilization associated with all Medicare Providers and Elimination 1881(b)(14)(F) of the Act, beginning in the implementation of the expanded of the Cap on Bad Debt Reimbursement CY 2012, ESRD PPS payment amounts to ESRD Facilities bundle, the 1 percent target for outlier and the composite rate portion of the payments was not achieved in CY 2011. This final rule also implements the transition blended payment amounts Use of 2011 data to recalibrate the changes to the limitations on payments shall be annually increased by an ESRD thresholds, reflecting lower utilization for bad debt reimbursement set forth in market basket percentage increase factor of epoetin and other outlier services, is reduced by a multi-factor productivity section 3201 of The Middle Class Tax expected to result in aggregate outlier (MFP) adjustment. The CY 2013 ESRDB Extension and Job Creation Act of 2012 payments close to the 1 percent target in (Pub. L. 112–96) by revising 42 CFR market basket increase factor is 2.9 percent. The current forecast of the CY CY 2013. We believe this update to the 413.89, Bad debts, charity, and courtesy outlier MAPs and fixed dollar loss allowances. Additionally, this rule will 2013 MFP adjustment is 0.6 percent. The resulting final CY 2013 MFP- amounts for CY 2013 will increase remove the cap on bad debt payments for ESRD beneficiaries reimbursement to ESRD facilities. adjusted ESRDB market basket update is equal to 2.3 percent. requiring higher resource utilization in B. Summary of the Major Provisions • The transition budget-neutrality accordance with a 1 percent outlier policy. 1. ESRD PPS adjustment factor: For CY 2013, we are applying the transition budget- • • Policy reiteration (composite rate Update to the composite and ESRD neutrality adjustment methodology drugs and AY modifier): Under the PPS base rate for CY 2013: For CY 2013, established in CY 2011. This results in composite and basic case-mix adjusted the ESRD PPS base rate is $240.36. This a 0.1 percent adjustment. Therefore, for composite rate payment systems, certain amount reflects the application of the CY 2013, a 0.1 percent increase will be drugs were included in the composite ESRD bundled (ESRDB) market basket applied to both the blended payments rate and were not eligible for separate reduced by the productivity adjustment, made under the transition and payments payment. Our analyses of claims show or 2.3 percent, and the wage index made under the full ESRD PPS for renal that ESRD facilities are continuing to budget-neutrality adjustment factor of dialysis services furnished January 1, 1.000613 to the CY 2012 ESRD PPS base report composite rate drugs on ESRD 2013 through December 31, 2013. claims. In this rule, we are reiterating rate of $234.81. The base rate is • Updates to the wage index and that any item or service included in the applicable to both the ESRD PPS portion wage index floor: We adjust wage of the blended payment under the indices on an annual basis using the composite rate should not be identified transition and payments under the full most current hospital wage data to on ESRD claims. An AY modifier can be PPS. During the transition, we are account for differing wage levels in appended to claims for drugs and required to update the composite rate areas in which ESRD facilities are laboratory tests that are not ESRD- for ESRD facilities receiving a blended located. In CY 2013, we are not making related to allow for separate payment. payment. For CY 2013, the composite any changes to the application of the Our analyses of claims show that there base rate is $145.20. This amount wage index budget-neutrality are ESRD facilities and laboratories that reflects the CY 2012 composite rate of adjustment factor and will continue to are appending the AY modifier to drugs $141.94, increased by the ESRDB market apply the budget-neutrality adjustment and laboratory tests that we believe are basket reduced by the productivity to the pre-floor, pre-reclassified wage ESRD-related, resulting in separate adjustment. index values for the composite rate payment. In this rule, we reiterate the • Update to the composite rate drug portion of the blended payment and to purpose of the AY modifier and add-on for CY 2013: There are no the base rate for the ESRD PPS. Over the emphasize that we are continuing our changes to the methodology used to past several years, we have been monitoring efforts. We also indicate that compute the drug add-on for CY 2013; gradually decreasing the wage index we may consider eliminating the AY we are only updating the data used to floor by 0.05 in an effort to gradually modifier in future rulemaking if we calculate the drug add-on for CY 2013. phase out the floor, and in CY 2013 we believe that the AY modifier is not being Using 6 years of average sales price will continue to do so. Therefore, in CY used for the purpose intended.

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2. ESRD QIP cross reference in 42 CFR 417.536(f)(1) collection of information are critical to This final rule also implements new to Medicare bad debt reimbursement better understanding the quality of care requirements for the ESRD QIP. It will policy. Finally, this final rule will beneficiaries receive, particularly a continue some of the previous ESRD eliminate the cap on bad debt patient’s experience of care, and will be QIP measures, add new measures, and reimbursement to an ESRD facility at its used to incentivize improvements in the expand the scope of some of the existing unrecovered costs. quality of care provided. measures to cover the measure topics as C. Summary of Costs and Benefits 3. Impacts of Bad Debt Provisions follows: In section VI.B of this final rule, we We are codifying the provisions of • To evaluate anemia management: set forth a detailed analysis of the section 3201 of The Middle Class Tax Æ Hemoglobin Greater Than 12 g/dL, impacts that the changes will have on Extension and Job Creation Act of 2012 a clinical measure. affected entities and beneficiaries. The that requires reductions in bad debt Æ Anemia Management, a reporting impacts include the following: reimbursement to all providers eligible measure.* to receive bad debt reimbursement; • To evaluate dialysis adequacy: 1. Impacts of the Final ESRD PPS these provisions are specifically Æ A clinical Kt/V measure for adult The impact chart in section VI.B of prescribed by statute and thus, are hemodialysis patients.* this final rule displays the estimated generally self-implementing. There will Æ A clinical Kt/V measure for adult change in payments to ESRD facilities in be a $10.92 billion savings to the peritoneal dialysis patients. * CY 2013 as compared to estimated program over 10 years resulting from Æ A clinical Kt/V measure for payments in CY 2012. The overall these self-implementing reductions in pediatric in-center hemodialysis impact of the CY 2013 changes is bad debt reimbursement. We are also patients. * projected to be a 3.0 percent increase in removing the cap on reimbursement for • To determine whether patients are payments. Hospital-based ESRD bad debt to ESRD facilities for cost treated using the most beneficial type of facilities have an estimated 3.6 percent reporting periods beginning on or after vascular access: increase in payments compared with January 1, 2013, which will result in a Æ Vascular Access Type, a clinical freestanding facilities with an estimated cost to the Medicare program of $170 measure topic comprised of an 2.9 percent increase. Urban facilities are million over 10 years. arteriovenous fistula and a catheter expected to receive an estimated measure. payment increase of 3.0 percent II. Calendar Year (CY) 2013 End-Stage • To address effective bone mineral compared to an estimated 2.9 percent Renal Disease (ESRD) Prospective metabolism management: increase for rural facilities. We expect a Payment System (PPS) Æ Mineral Metabolism, a reporting 2.4 percent decrease in estimated A. Background on the End-Stage Renal measure. payments as a result of wage index Disease (ESRD) Prospective Payment • To address safety: adjustments for Puerto Rico and the System (PPS) Æ National Healthcare Safety Network Virgin Islands. However, this decrease is (NHSN) Dialysis Event reporting offset primarily by the impact of the On August 12, 2010, we published in measure. market basket increase, resulting in an the Federal Register a final (75 FR • To assess patient and caregiver estimated 0.6 percent increase in 49030) titled, ‘‘End-Stage Renal Disease experience: payment. The estimated 3.0 percent Prospective Payment System’’, Æ In-Center Hemodialysis Consumer overall payment increase will result in hereinafter referred to as the CY 2011 Assessment of Healthcare Providers and a $250 million cost to Medicare and a ESRD PPS final rule. In the CY 2011 Systems (ICH CAHPS) survey reporting $60 million cost to beneficiaries. In ESRD PPS final rule, we implemented a measure. 2013, a 2.3 percent market basket case-mix adjusted bundled PPS for * Denotes that this measure is new to increase will result in a $190 million Medicare outpatient ESRD dialysis the ESRD QIP. cost to Medicare and a $50 million cost services beginning January 1, 2011, in This final rule also establishes CY to beneficiaries. The outlier fixed dollar accordance with section 1881(b)(14) of 2013 as the performance period for the loss and MAP adjustments in CY 2013 the Act, as added by section 153(b) of PY 2015 ESRD QIP. It also establishes will result in a $30 million cost to MIPPA. performance standards for each measure Medicare and a $10 million cost to On April 6, 2011, we published in the and adopts scoring and payment beneficiaries. The difference in cost to Federal Register an interim final rule reduction methodologies that are similar Medicare is due to the effects of with comment period (76 FR 18930) to those finalized for the PY 2014 ESRD changing the blend of payments from titled, ‘‘Changes in the End-Stage Renal QIP. 50/50 to 25/75 and the 0.1 percent Disease Prospective Payment System transition budget-neutrality adjustment. Transition Budget-Neutrality 3. Reductions to Bad Debt Payments for Adjustment’’, which revised the ESRD all Medicare Providers and Elimination 2. Impacts for ESRD QIP transition budget-neutrality adjustment of the Cap on Bad Debt Reimbursement The overall economic impact of the for CY 2011. In the interim final rule, to ESRD Facilities ESRD QIP is an estimated $24.6 million we revised the 3.1 percent transition This rule also implements the for PY 2015. We expect the total budget-neutrality adjustment reduction statutory changes to the limitations on payment reductions to be approximately to a zero percent transition budget- payments for bad debt reimbursement $12.1 million, and the costs associated neutrality adjustment for renal dialysis by revising 42 CFR 413.89, Bad debts, with the collection of information services furnished on April 1, 2011 charity, and courtesy allowances. We requirements for certain measures to be through December 31, 2011 (76 FR are also moving 42 CFR 413.178(a) to 42 approximately $12.4 million. 18933). On November 10, 2011, we CFR 413.89(h)(3), and moving 42 CFR The estimated payment reduction will published in the Federal Register, a 413.178(d)(2) to 42 CFR 413.89(i)(2) and continue to incentivize facilities to final rule (76 FR 70228 through 70316) removing and reserving the remainder provide higher quality care to titled, ‘‘Medicare Program; End-Stage of 42 CFR 413.178. Additionally, we are beneficiaries. The reporting measures Renal Disease Prospective Payment making a technical correction to the that result in costs associated with the System and Quality Incentive Program;

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Ambulance Fee Schedule; Durable update the composite rate portion of the 2013 ESRD market basket increase factor Medical Equipment; and Competitive blended payment during the transition, of 2.9 percent reduced by the Acquisition of Certain Durable Medical (that is, CY 2011 through 2013), which productivity adjustment of 0.6 percent. Equipment, Prosthetics, Orthotics and includes updates to the drug add-on The resulting CY 2013 MFP-adjusted Supplies (hereinafter referred to as the adjustment required by section ESRD market basket update is 2.3 CY 2012 ESRD PPS final rule). In that 1881(b)(12)(F) of the Act, discussed in percent ($141.94 × 1.023 = $ 145.20). section II.C.1.a of this final rule, as well final rule, for the ESRD PPS, we made a. Update to the Drug Add-On to the as the wage index values (which a number of routine updates for CY Composite Rate Portion of the ESRD includes a budget-neutrality factor) used 2012, implemented the second year of Blended Payment Rate the transition to the ESRD PPS, made to adjust the labor component of the several policy changes, clarifications, composite rate discussed in section Section 1881(b)(14)(E)(i) of the Act and technical changes. In the CY 2013 II.C.5 of this final rule. For CY 2013, we requires a 4-year transition under the ESRD PPS proposed rule (77 FR 40956), proposed to update the second part of ESRD PPS. Under 42 CFR 413.239, we summarize the updates, changes, the transition budget-neutrality ESRD facilities were permitted to make and clarifications that were finalized in adjustment to reflect updated data. The a one-time election by November 1, the CY 2012 ESRD PPS final rule (76 FR transition budget-neutrality adjustment 2010, to be excluded from the transition 70228). is applied to both the blended payments and receive full payment under the under the transition and payments ESRD PPS. Under § 413.239(a)(3), in CY B. Summary of the Proposed Provisions under the ESRD PPS. The discussion 2013, ESRD facilities that elected to and Responses to Comments on the CY regarding the transition budget- receive payment under the transition 2013 ESRD PPS neutrality adjustment can be found in will be paid a blended amount The proposed rule, titled ‘‘Medicare section II.C.4 of this final rule. consisting of 25 percent of the basic Program; End-Stage Renal Disease As discussed in the CY 2013 ESRD case-mix adjusted composite payment Prospective Payment System, Quality PPS proposed rule (76 FR 40957), system payment and 75 percent of the Incentive Program, and Bad Debt section II.C.3 of this final rule, and in ESRD PPS payment. Thus, we must Reductions for All Medicare Providers’’ section 1881(b)(14)(F)(ii) of the Act, as continue to update the composite rate (77 FR 40952), hereinafter referred to as added by section 153(b) of MIPPA and portion of the blended payment amount the CY 2013 ESRD PPS proposed rule amended by section 3401(h) of the during the ESRD PPS transition (CY appeared in the Federal Register on July Affordable Care Act, for the years in 2011 through 2013), which includes an 11, 2012, with a comment period that which the transition applies, the update to the drug add-on. ended on August 31, 2012. In that composite base rate shall be annually As required under section 1881(b)(12) proposed rule, for the ESRD PPS, we increased by the ESRDB market basket of the Act, the basic case-mix adjusted proposed to (1) make a number of and, for CY 2012 and each subsequent composite payment system includes the routine updates for CY 2013, (2) year, the ESRDB market basket shall be services in the composite rate and an implement the third year of the reduced by the productivity adjustment add-on to the composite rate portion of transition, and (3) make several policy described in section 1886(b)(3)(B)(xi)(II) the blended payment to account for the changes and clarifications. We received of the Act. In the CY 2013 ESRD PPS difference between pre-Medicare approximately 40 public comments on proposed rule (77 FR 40957), we Modernization Act payments for the ESRD PPS proposals, including proposed for CY 2013 a composite rate separately billed drugs and the revised comments from ESRD facilities; national of $145.49, which reflected the CY 2012 drug pricing specified in the statute. For renal, nephrologist and patient composite rate of $141.94 increased by the drug add-on for CY 2013 (77 FR organizations; patients; manufacturers; an ESRDB market basket of 3.2 reduced 40957 through 40959), we did not health care systems; and nurses. In this by the productivity adjustment of 0.7 propose any changes to the drug add-on final rule, we provide a summary of percent, resulting in an update of 2.5 methodology, but merely updated the each proposed provision, a summary of percent, based on the first quarter 2012 data used in computing the drug add-on the public comments received and our IGI forecast of the ESRDB market basket. as described below. We received four public comments responses to them, and the policies we supporting our proposal to increase the i. Estimating Growth in Expenditures for are finalizing for the CY 2013 ESRD composite base rate by 2.5 percent for Drugs and Biologicals in CY 2013 PPS. ESRD services furnished in CY 2013 and Section 1881(b)(12)(F) of the Act C. Routine Updates and Proposed Policy paid under the blended payment specifies that the drug add-on increase Changes to the CY 2013 ESRD PPS methodology during the transition must reflect ‘‘the estimated growth in period. expenditures for drugs and biologicals 1. Composite Rate Portion of the ESRD In section II.C.3.b of this final rule, we (including erythropoietin) that are PPS Blended Payment finalize the CY 2013 ESRDB market separately billable * * *’’. By referring Section 1881(b)(14)(E)(i) of the Act basket update of 2.9 percent, and the to ‘‘expenditures’’, we believe the requires a 4-year transition under the MFP adjustment of 0.6 percent, which statute contemplates that the update ESRD PPS. This final rule implements results in a forecasted rate of increase to would account for both increases in the third year of the transition for those the base rate of 2.3 percent. This final drug prices, as well as increases in ESRD facilities that did not elect to update is based on the third quarter utilization of those drugs. receive 100 percent of the payment 2012 IGI forecast of the ESRDB market As we indicated in the CY 2013 ESRD amount under the ESRD PPS. For CY basket. Consequently for CY 2013, we PPS proposed rule (77 FR 40957), we 2013, under 42 CFR 413.239(a)(3), are finalizing the composite base rate continue to estimate growth in drug facilities that are transitioning will under the ESRD PPS payment of expenditures based on the trends in receive a blended rate equal to the sum $145.20 for ESRD services furnished available data. To account for increases of 75 percent of the full ESRD PPS during CY 2013 and paid under the in drug prices and utilization for CY amount and 25 percent of the basic case- blended payment methodology. This 2013 we used the 6 years of available mix adjusted composite payment amount reflects the CY 2012 composite drug expenditure data based on ASP amount. Accordingly, we continue to rate of $141.94 increased by the CY pricing. We then removed growth in

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enrollment for the same time period For this CY 2013 final rule, using the final rule with comment is 70 FR 70166 from the expenditure growth so that the full year 2011 drug expenditure figure and 70167. In the CY 2006 rule, we residual reflects the per patient based on the June 2012 update of the CY applied the projected growth percentage expenditure growth (which includes 2011 National Claims History File, we to the total amount of drug add-on price and utilization combined). calculated the average annual change in dollars established for CY 2005 to To estimate drug expenditure growth drug expenditure from 2006 through establish a dollar amount for the CY using trend analysis, for CY 2013, we 2011. This average annual change 2006 growth. In addition, we projected looked at the average annual growth in showed a decrease of 2.9 percent in the growth in dialysis treatments for CY total drug expenditures between 2006 drug expenditures from 2006 through 2006 based on the projected growth in and 2011. First, we estimated the total 2011. We used this 2.9 decrease to ESRD enrollment. We divided the drug expenditures for all ESRD facilities project drug expenditures for both 2012 projected total dollar amount of the CY in CY 2011. We used the final CY 2006 and 2013. We note that the decrease in 2006 growth by the projected total through CY 2010 ESRD claims data and the drug expenditures percentage is a dialysis treatments to develop the per the latest available CY 2011 ESRD result of our use of updated data. treatment growth update amount. This growth update amount, combined with facility claims, updated through ii. Estimating Per Patient Growth December 31, 2011 (that is, claims with the CY 2005 per treatment drug add-on dates of service from January 1 through In the CY 2013 ESRD PPS proposed amount, resulted in a 14.7 percent December 31, 2011, that were received, rule (77 FR 40958), we explained that adjustment to the composite rate for CY processed, paid, and passed to the once we had the projected growth in 2006. National Claims History File as of drug expenditures from 2012 to 2013, We further explained in the CY 2013 December 31, 2011). We indicated in the we calculated per patient growth ESRD PPS proposed rule (77 FR 40958), between CYs 2012 and 2013 by CY 2013 ESRD PPS proposed rule (77 that subsequent to the publication of the removing the estimated growth in FR 40958) that for the CY 2013 PPS final CY 2006 PFS final rule with comment, enrollment data between CYs 2012 and rule, we would use additional updated the Deficit Reduction Act (DRA) of 2005 2013. We had estimated a 4.6 percent CY 2011 claims with dates of service for (Pub. L. 109–171) was enacted on growth in fee-for-service Medicare the same timeframe. This updated CY February 8, 2006. Section 5106 of the dialysis beneficiary enrollment between 2011 data file would include claims DRA amended section 1881(b)(12) of the CYs 2012 and 2013. To obtain the per- received, processed, paid, and passed to Act to require the Secretary to increase patient estimated growth in the National Claims History File as of the amount of the composite rate expenditures, we divided the total drug June 30, 2012. We further stated that component of the basic case-mix expenditure change of a 3 percent while the CY 2011 claims file used in adjusted system for dialysis services decrease between 2012 and 2013 (0.97) furnished on or after January 1, 2006 by the proposed rule was the most current by enrollment growth of 4.6 percent 1.6 percent above the amount of the available, we recognize that it does not (1.046) for the same timeframe. The composite rate for such services reflect a complete year, as claims with result was a per-patient growth factor furnished on December 31, 2005. We dates of service towards the end of the equal to 0.927 (0.97/1.046 = 0.927). issued Change Request 4291, year have not all been processed. To Thus, we are projecting a 7.3 percent Transmittal 849, entitled, ‘‘Update to more accurately estimate the update to decrease (¥7.3% = ¥.073 = 0.927 ¥1) the ESRD Composite Payment Rates’’ on the drug add-on, completed aggregate in per patient growth in drug February 10, 2006 to instruct contractors drug expenditures are required. expenditures between CYs 2012 and to implement this change. We stated in In the CY 2013 ESRD PPS proposed 2013. Change Request 4291 that because the rule (77 FR 40958), we inflated the CY For this final rule, we estimate a 4.0 drug add-on adjustment is determined 2011 drug expenditures to estimate the percent estimated growth in enrollment as a percentage of the composite rate, it June 30, 2012 update of the 2011 claims between CYs 2012 and 2013. To obtain was necessary to adjust the drug add-on file. We used the relationship between the per-patient estimated growth in percentage to account for the 1.6 percent the December 2010 and the June 2011 expenditures, we divided the total drug increase in the composite payment rate. versions of 2010 claims to estimate the expenditure change of a 2.9 percent Therefore, the total drug add-on more complete 2011 claims that were decrease between CYs 2012 and 2013 adjustment to the composite payment available in June 2012 and applied that (0.971) by enrollment growth of 4.0 rate for 2006 was 14.5 percent instead ratio to the 2011 claims data from the percent (1.04) for the same timeframe. of 14.7 percent. December 2011 claims file. The net The result is a per-patient growth factor Finally, we explained in the CY 2013 adjustment to the CY 2011 claims data equal to 0.934 (.971/1.04=.934). Thus, in ESRD PPS proposed rule (77 FR 40958) was an increase of 9.7 percent to the this final rule, for CY 2013 we are that in the CY 2007 PFS final rule with 2011 expenditure data. This adjustment projecting a 6.6 percent decrease comment period (71 FR 69683 and allows us to more accurately compare (¥6.6% percent =¥.063=.934¥1) in 69684), we revised our update the 2010 and 2011 drug expenditure per patient growth in drug expenditures methodology by applying the growth data to estimate per patient growth. between CYs 2012 and 2013. update to the per treatment drug add-on We further stated in the CY 2013 amount. That is, for CY 2007, we ESRD PPS proposed rule (77 FR 40958), iii. Applying the Proposed Growth applied the growth update factor of 4.03 that using the completed full-year 2011 Update to the Drug Add-On Adjustment percent to the $18.88 per treatment drug drug expenditure figure, we calculated We explained in the CY 2013 ESRD add-on amount resulting in an updated the average annual change in drug PPS proposed rule (77 FR 40958), that per treatment drug add-on amount of expenditures from 2006 through 2011. in the CY 2012 ESRD PPS proposed and $19.64 per treatment (71 FR 69684). For This average annual change showed a final rules, we provided an incorrect CY 2008, the per treatment drug add-on decrease of 3.0 percent in drug citation to the CY 2006 PFS final rule amount was updated to $20.33. In the expenditures from 2006 through 2011. with comment in the discussion of the CYs 2009, 2010, and 2011 PFS final rule We used this 3.0 percent decrease to application of the projected growth with comment period (73 FR 69755 project drug expenditures for both 2012 update percentages. The correct citation through 69757, 74 FR 61923, and 75 FR and 2013. to this discussion in the CY 2006 PFS 73485, respectively) and the CY 2012

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ESRD PPS final rule (76 FR 70239), we ESRD PPS payment resulting in a 2. ESRD PPS Base Rate applied a zero update to the per decrease to the CY 2013 drug add-on treatment drug add-on amount resulting adjustment from 14.3 to 14.0 percent, to In the CY 2013 ESRD PPS proposed in a per treatment drug add-on amount maintain the drug add-on at $20.33. rule (77 FR 40959) and CY 2012 ESRD of $20.33. For CY 2013, we did not This decrease occurs because the drug PPS final rule (76 FR 70231), we make any update to the per treatment add-on adjustment is a percentage of the discussed the development of the ESRD drug add-on amount of $20.33 composite rate. Since the proposed CY PPS per treatment base rate that is established in CY 2008. 2013 composite rate is higher than the codified in the Medicare regulations at As discussed in detail below, in this CY 2012 composite rate and since the 42 CFR 413.220 and 413.230. We final rule, for CY 2013, we are finalizing drug add-on remains at $20.33, the explained that the CY 2011 ESRD PPS a zero update to the per treatment drug percentage decreases. Therefore, we final rule (75 FR 49071 through 49082) add-on amount of $20.33 established in proposed a drug add-on adjustment to provides a detailed discussion of the methodology used to calculate the ESRD CY 2008. the composite rate for CY 2013 of 14.0 PPS base rate and the computation of percent. iv. Update to the Drug Add-On factors used to adjust the ESRD PPS Adjustment for CY 2013 We did not receive any comments on base rate for projected outlier payments As discussed above, in the CY 2013 our proposals to use a zero update to the and budget-neutrality in accordance ESRD PPS proposed rule (77 FR 40958), drug add-on or on the proposed drug- with sections 1881(b)(14)(D)(ii) and we estimated a 3.0 percent decrease in add on adjustment to the composite rate 1881(b)(14)(A)(ii) of the Act, drug expenditures between CYs 2012 for CY 2013 of 14.0 percent. respectively. Specifically, the ESRD PPS and 2013. Combining this decrease with In this final rule, for CY 2013, we base rate was developed from CY 2007 a 4.6 percent increase in enrollment, as estimate a 2.9 percent decrease in drug claims (that is, the lowest per patient described above, we projected a 7.3 expenditures between CYs 2012 and utilization year), updated to CY 2011, percent decrease in per patient growth 2013. Combining this increase with a and represented the average per of drug expenditures between CYs 2012 4.0 percent increase in enrollment, we treatment Medicare Allowable Payment and CY 2013. Therefore, in the CY 2013 project a 6.6 percent decrease in per (MAP) for composite rate and separately ESRD PPS proposed rule, we projected patient growth of drug expenditures billable services. We further explained that the combined growth in per patient between CYs 2012 and 2013. Therefore, that in accordance with 42 CFR 413.230, utilization and pricing for CY 2013 we project that the combined growth in the ESRD PPS base rate is adjusted for would result in a decrease to the drug per patient utilization and pricing for the patient-specific case-mix add-on equal to 1.0 percentage points CY 2013 results in a decrease to the adjustments, applicable facility (out of the revised 14.0 percent add-on drug add-on equal to 0.9 percentage adjustments, geographic differences in for 2013). This figure was derived by points. This figure is derived by area wage levels using an area wage applying the 7.3 percent decrease to the applying the 6.6 percent decrease to the index, as well as any outlier payment or CY 2012 drug add-on of $20.33. This CY 2012 drug add-on of $20.33. This training payments (if applicable). For resulted in a revised drug add-on of results in a revised drug add-on of CY 2012, the ESRD PPS base rate was $18.85, which is 13.0 percent of the $18.98, which is 13.1 percent of the $234.81 (76 FR 70231). proposed CY 2013 base composite rate final CY 2013 base composite rate of We also indicated in the CY 2013 of $145.49. We indicated that if we were $145.20. Applying no decrease to the to apply no decrease to the drug add-on ESRD PPS proposed rule (77 FR 40959) drug add-on of $20.33 results in a 14.0 of $20.33, this would result in a 14.0 that section 1881(b)(14)(F)(i) of the Act, percent drug add-on. Similar to last year percent drug add-on. However, similar as added by section 153(b) of MIPPA and as discussed above, for CY 2013, we to last year and as indicated above, we and amended by section 3401(h) of the are finalizing a zero update to the drug proposed a zero update to the drug add- Affordable Care Act, provides that, on adjustment. We believe this add-on and maintaining the $20.33 per beginning in 2012, the ESRD PPS approach is consistent with the treatment drug add-on amount. payment amounts are required to be language under section 1881(b)(12)(F) of The current $20.33 per treatment drug annually adjusted by the rate of increase the Act, which states in part that ‘‘the add-on reflected a 14.3 percent drug in the ESRD market basket, reduced by Secretary shall annually increase’’ the add-on adjustment to the composite rate the productivity adjustment. drug add-on amount based on the in effect for CY 2012. Using the latest Accordingly, in the CY 2013 ESRD PPS growth in expenditures for separately ESRDB market basket minus proposed rule, we applied the 2.5 billed ESRD drugs. Therefore, we productivity adjustments to update the percent increase to the CY 2012 ESRD proposed to apply a zero update and composite rate portion of the ESRD PPS PPS base rate of $234.81, which resulted payment (forecast of 2.3 percent in CY in a proposed CY 2013 ESRD PPS base maintain the $20.33 per treatment drug × add-on amount for CY 2013. We sought 2013 effective January 1, 2013, as rate of $240.68 ($234.81 1.025 = comment on our proposed zero update discussed in section II.C.3 of this final $240.68). The ESRD PPS base rate is to the drug add-on. rule), results in a decrease to the CY applicable to both the ESRD PPS portion We further stated in the CY 2013 2013 drug add-on adjustment from 14.3 of the blended payment under the ESRD PPS proposed rule (77 FR 40959), to 14.0 percent in order to maintain the transition and payments under the full that the current $20.33 per treatment drug add-on amount of $20.33. This ESRD PPS. drug add-on reflected a 14.3 percent decrease occurs because the drug add- In addition, for CY 2013, we proposed drug add-on adjustment to the on adjustment is a percentage of the a wage index budget-neutrality composite rate in effect for CY 2012. As composite rate. Because the final CY adjustment factor of 1.000826 to be discussed in section II.3.a of the CY 2013 composite rate is higher than CY applied to the CY 2013 ESRD PPS base 2013 ESRD PPS proposed rule, section 2012 composite rate, and since the drug rate (that is, $240.68), which yielded a 1881(b)(14)(F) of the Act requires that add-on remains at $20.33, the proposed CY 2013 ESRD PPS wage an ESRDB market basket minus percentage decreases. Therefore, we are index budget-neutrality adjusted base productivity adjustment be used to finalizing for CY 2013 the drug add-on rate of $240.88 ($240.68 × 1.000826 = update the composite rate portion of the adjustment of 14.0 to the composite rate. $240.88).

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Comment: All commenters supported b. Market Basket Update Increase Factor c. Productivity Adjustment our CY 2013 ESRD PPS wage index and Labor-related Share for ESRD The ESRDB market basket must be budget-neutrality adjusted base rate. Facilities for CY 2013 annually adjusted by changes in Two commenters thanked CMS for economy-wide productivity. providing an update to the base rate, As required under section 1881(b)(14)(F) of the Act, CMS Specifically, under section and one commenter specifically 1881(b)(14)(F)(i) of the Act, as amended developed an all-inclusive ESRDB input appreciated the base rate increase at a by section 3401(h) of the Affordable price index (75 FR 49151 through time when the Medicare ESRD program Care Act, for CY 2012 and each 49162). Although ‘‘market basket’’ is undergoing significant changes and subsequent year, the ESRD market noted that it is important to retain technically describes the mix of goods basket percentage increase factor shall savings where applicable. and services used to produce ESRD care, be reduced by the productivity Response: We thank the commenters this term is also commonly used to adjustment described in section for their support. In this final rule, using denote the input price index (that is, 1886(b)(3)(B)(xi)(II) of the Act. The updated data for CY 2013, we applied cost categories, their respective weights, statute defines the productivity the 2.3 percent increase (ESRDB market and price proxies combined) derived adjustment to be equal to the 10-year basket update less productivity) to the from that market basket. Accordingly, moving average of changes in annual CY 2012 ESRD PPS base rate of $234.81, the term ‘‘ESRDB market basket’’, as economy-wide private nonfarm business which results in an ESRD PPS base rate used in this document, refers to the × multifactor productivity (MFP) (as for CY 2013 of $240.21 ($234.81 1.023 ESRDB input price index. projected by the Secretary for the 10- = $240.21). In addition, we applied the year period ending with the applicable wage index budget-neutrality We proposed to use the same methodology described in the CY 2011 fiscal year, year, cost reporting period, adjustment factor of 1.000613 to the or other annual period) (the ‘‘MFP updated base rate of $240.21, yielding ESRD PPS final rule (75 FR 49151 through 49162) to compute the CY 2013 adjustment’’). The Bureau of Labor an ESRD PPS wage index budget- Statistics (BLS) is the agency that neutrality adjusted base rate for CY 2013 ESRDB market basket increase factor × and labor-related share based on the publishes the official measure of private of $240.36 ($240.21 1.000613 = nonfarm business MFP. Please see $240.36). best available data (76 FR 40503). Consistent with historical practice, we http://www.bls.gov/mfp to obtain the 3. ESRD Bundled Market Basket estimated the ESRDB market basket BLS historical published MFP data. CMS notes that the methodology for a. Overview and Background update based on IHS Global Insight calculating and applying the MFP (IGI), Inc.’s forecast using the most In accordance with section adjustment to the ESRD payment update recently available data. IGI is a 1881(b)(14)(F)(i) of the Act, as added by is similar to the methodology used in nationally recognized economic and section 153(b) of MIPPA and amended other payment systems, as required by by section 3401(h) of the Affordable financial forecasting firm that contracts section 3401 of the Affordable Care Act. Care Act, beginning in 2012, the ESRD with CMS to forecast the components of The projection of MFP is currently bundled payment amounts are required the market baskets. produced by IGI. The details regarding to be annually increased by an ESRD Using this methodology and the IGI the methodology for forecasting MFP market basket increase factor that is forecast for the third quarter of 2012 of and how it is applied to the market reduced by the productivity adjustment the CY 2008-based ESRDB market basket was finalized in the CY 2012 described in section 1886(b)(3)(B)(xi)(II) basket (with historical data through the ESRD PPS final rule (76 FR 70232 of the Act. The application of the second quarter of 2012), and consistent through 70234). Using this method and productivity adjustment described may with our historical practice of the IGI forecast for the third quarter of result in the increase factor being less estimating market basket increases 2012 of the 10-year moving average of than 0.0 for a year and may result in based on the best available data, the CY MFP, the CY 2013 MFP factor is 0.6 payment rates for a year being less than 2013 ESRDB market basket increase percent. the payment rates for the preceding factor is 2.9 percent. year. The statute further provides that d. Calculation of the ESRDB Market the market basket increase factor should For the CY 2013 ESRD payment Basket Update, Adjusted for Multifactor reflect the changes over time in the update, we will continue to use a labor- Productivity for CY 2013 prices of an appropriate mix of goods related share of 41.737 percent for the Under section 1881(b)(14)(F) of the and services used to furnish renal ESRD PPS payment and the ESRD PPS Act, beginning in CY 2012, ESRD PPS dialysis services. Under section portion of the blended payment, which payment amounts and the composite 1881(b)(14)(F)(ii) of the Act, as added by was finalized in the CY 2011 ESRD final rate portion of the transition blended section 153(b) of MIPPA and amended rule (75 FR 49161). We will also payment amounts shall be annually by section 3401(h) of the Affordable continue to use a labor-related share of increased by an ESRD market basket Care Act, the ESRDB market basket 53.711 percent for the ESRD composite percentage increase factor reduced by a increase factor will also be used to rate portion of the blended payment for productivity adjustment. We proposed update the composite rate portion of all years of the transition. This labor- to follow the same methodology for ESRD payments during the ESRD PPS related share was developed from the calculating the ESRDB market basket transition period from CYs 2011 through labor-related components of the 1997 updates adjusted for MFP that was 2013; though beginning in CY 2012, ESRD composite rate market basket that finalized in the CY 2012 ESRD PPS final such market basket increase factor will was finalized in the CY 2006 Physician rule (76 FR 70234). be reduced by the productivity Fee Schedule (PFS) final rule (70 FR Thus, in accordance with section adjustment. Therefore, a full market 70168), and is consistent with the mix 1881(b)(14)(F)(i) of the Act, the market basket was applied to the composite rate of labor-related services paid under the basket increase factor for CY 2013 for portion of the blended payment in CY composite rate, as well as the method the ESRDB market basket is based on 2011 during the first year of the finalized in the CY 2011 ESRD PPS final the 3rd quarter 2012 forecast of the CY transition. rule (75 FR 49116). 2008-based ESRDB market basket

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update, which is estimated to be 2.9 treatment amount of $0.49 to the would be applied to both the blended percent. This market basket percentage composite rate (76 FR 70231). For the payments made under the transition and is then reduced by the MFP adjustment second part, we explained that we payments made under the 100 percent (the 10-year moving average of MFP for computed a factor that would make the ESRD PPS) for renal dialysis items and the period ending CY 2013) of 0.6 estimated total amount of payments services furnished January 1, 2013 percent, which is based on IGI’s 3rd under the ESRD PPS, including through December 31, 2013 (77 FR quarter 2012 forecast. The resulting payments under the transition, equal to 40957). We solicited comments on the MFP-adjusted ESRDB market basket the estimated total amount of payments proposed second part of the CY 2013 update for CY 2013 is equal to 2.3 that would otherwise occur without transition budget-neutrality adjustment. percent, or 2.9 percent less 0.6 such a transition. We received three comments as set percentage point. Given that the transition budget- We received two comments in neutrality adjustment required under forth below. support of the market basket update. We section 1881(b)(14)(E)(iii) of the Act Comment: All of the commenters are finalizing the update to the ESRDB applies in each year of the transition, we supported using updated data and market basket of 2.3 percent for CY must update the transition budget- maintaining a zero percent budget- 2013. neutrality adjustment for CY 2013, the neutrality transition adjustment for CY third year of the transition. As discussed 2013. 4. Transition Budget-Neutrality in detail below, and in accordance with Adjustment for CY 2013 Response: We thank the commenters section 1881(b)(14)(E)(iii) of the Act, an for their support of our proposed use of Section 1881(b)(14)(E)(i) of the Act adjustment is made to payments so that updated data and a transition budget- requires the Secretary to provide a 4- estimated total payments under the neutrality factor of zero percent for renal year phase-in of the payments under the transition equal estimated total payment ESRD PPS for renal dialysis services dialysis services furnished during amounts without such a transition. January 1, 2013 through December 31, furnished on or after January 1, 2011, In the CY 2013 ESRD PPS proposed 2013. As we indicated above, for the with payments under the ESRD PPS rule, we did not propose to change the proposed rule, we used the December fully implemented for renal dialysis methodology used to calculate either services furnished on or after January 1, part of the transition budget-neutrality 2011 claims file to compute the 2014. Although the statute uses the term adjustment factor. We did, however, transition budget-neutrality adjustment ‘‘phase-in,’’ we use the term propose to use updated data to calculate factor. For this final rule, we used the ‘‘transition’’ in our discussions in order the second part of the transition budget- June 2012 claims file. As a result of to be consistent with other Medicare neutrality adjustment factor. The first using the June 2012 claims file, we payment systems. part, which is the Part D payment calculated the transition budget- Section 1881(b)(14)(E)(ii) of the Act amount added to the composite rate, is neutrality factor to be a reduction of 1 permitted ESRD facilities to make a one- updated annually by the ESRDB market minus the ratio of estimated payments time election to be excluded from the basket reduced by the productivity under the ESRD PPS as if there were no transition. An ESRD facility that elected adjustment. The second part is updated transition to the total estimated to be excluded from the transition as described below. payments under the transition, which receives payment for renal dialysis For CY 2013, we started with 2011 results in a 0.1 percent increase factor services furnished on or after January 1, utilization data from claims, as 2011 is for CY 2013. We believe the claims data 2011, based on 100 percent of the the latest complete year of claims data we used to perform our analysis payment rate under the ESRD PPS available. In the CY 2013 ESRD PPS resulted in the change in the transition rather than a blended payment based in proposed rule, we used the December budget-neutrality adjustment factor from part on the payment under the basic 2011 claims file. In this final rule, we the zero factor used in previous years to case-mix adjusted composite payment used the June 2012 claims file. We the 0.1 percent increase factor for CY system and in part on the payment updated the CY 2011 utilization data to 2013. We note that in past years, the under the ESRD PPS. Section CYs 2012 and 2013 payments by using transition budget-neutrality factor has 1881(b)(14)(E)(iii) of the Act also the price growth factors for CYs 2012 not always been an absolute zero, but requires that we make an adjustment to and 2013, as discussed in the impact was rounded to zero percent. The June payments during the transition so that analysis in section VI.C of this final 2012 claims file represents 2011 data, the estimated total amount of payments rule. We then took the estimated the first year of the PPS. In 2011, the under the ESRD PPS, including payments under the full CY 2013 ESRD utilization for separately billable drugs, payments under the transition, equals PPS and the blended payments under laboratory tests and other items dropped the estimated total amount of payments the transition based on actual facility significantly. For ESRD facilities that are that would otherwise occur under the election data and compared these paid under the transition, the decrease ESRD PPS without such a transition. We estimated payments to the total in utilization contributed to the refer to this provision as the transition estimated payments in CY 2013 as if all payment for the composite rate portion budget-neutrality adjustment. facilities had elected to receive payment of the blended payment being lower In the CY 2012 ESRD PPS final rule under the ESRD PPS. We then than the payment for the ESRD PPS (76 FR 70235), we discussed the two calculated the transition budget- portion of the blended payment. parts that comprise the transition neutrality factor to be 1 minus the ratio Therefore, total payments for all budget-neutrality adjustment factor. For of estimated payments under the ESRD facilities under the transition were the first part, we created a one-time PPS as if there were no transition to the lower than what payments would have payment adjustment to the composite total estimated payments under the been under the ESRD PPS, if there were rate portion of the blended payment transition, which results in a zero no transition. This widening difference during the transition to account for the percent reduction factor for CY 2013. In resulted in the transition budget- per treatment costs of ESRD drugs with the CY 2013 ESRD PPS proposed rule, neutrality adjustment rounding to 0.1 an injectable equivalent that were paid we proposed a zero percent reduction to for CY 2013. We are finalizing for CY under Part D. We finalized the one-time all payments made to ESRD facilities 2013 a transition budget-neutrality addition of the CY 2011 Part D per (that is, the zero percent adjustment adjustment of 0.1 percent.

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5. Updates to the Wage Index Values In the CY 2012 ESRD PPS final rule located in urban and rural areas where and Wage Index Floor for the Composite (76 FR 70240), we discussed that during there are no hospital data. That is, for Rate Portion of the Blended Payment the transition we would continue to urban areas with no hospital data we and the ESRD PPS Payment update the composite rate portion of the compute the average wage index value Section 1881(b)(14)(D)(iv)(II) of the ESRD PPS blended payment, including of all urban areas within the State and Act provides that the ESRD PPS may adjusting payments for geographic use that value as the wage index. For include such other payment differences in area wage levels, as noted rural areas with no hospital data, we adjustments as the Secretary determines above. We also discussed the compute the wage index using the appropriate, such as a payment application of the wage index budget- average wage index values from all adjustment by a geographic wage index, neutrality adjustment factor to the area contiguous CBSAs to represent a such as the index referred to in section wage index values for the composite reasonable proxy for that rural area. For 1881(b)(12)(D) of the Act. In the CY rate portion of the ESRD PPS blended rural Puerto Rico, we use the wage 2011 ESRD PPS final rule (75 FR 49117), payment. In the proposed rule, for CY index floor as the wage index value, we finalized the use of the OMB’s core- 2013 we did not propose any changes to since all rural Puerto Rico areas are based statistical area (CBSA) based the methodology for the wage index below the floor. We further explained that for rural geographic area designations to define used to adjust the composite rate Massachusetts, we determined that the urban/rural areas and corresponding portion of the ESRD PPS blended payment. borders of Dukes and Nantucket wage index values. In the CY 2012 Counties are contiguous with Barnstable ESRD PPS final rule (76 FR 70241), we a. Reduction to the ESRD Wage Index and Bristol counties. Under the finalized the wage index policy that is Floor methodology, the values for these used under the ESRD PPS. Under the In the CY 2012 ESRD PPS final rule counties are averaged to establish the ESRD PPS, we have adopted the same (76 FR 70239 through 70241), we wage index value for rural method and source of wage index values finalized that we will continue to Massachusetts. used previously to compute the wage reduce the wage index floor by 0.05 for After the CY 2012 ESRD PPS final index values for the basic case-mix each of the remaining years of the rule was published, we determined that adjusted composite payment system. transition. That is, we finalized the 0.05 for CY 2012 there was a rural hospital Specifically, we finalized our policies to reduction to the wage index floor for with wage data on which to base an area continue to utilize the methodology CYs 2012 and 2013, resulting in a wage wage index for rural Massachusetts. We established under the composite index floor of 0.550 and 0.500, note that the wage index value for rural payment system for updating the wage respectively. The wage index floor value Massachusetts was correctly identified index values using the OMB’s CBSA- is used in lieu of wage index values on the wage index table for CY 2012 based geographic area designations to below the floor. The wage index floor is based on the wage data for that rural define urban and rural areas and applied to both the composite rate hospital. Consequently, in the CY 2013 corresponding wage index values; the portion of the blend and to the ESRD ESRD PPS proposed rule we corrected gradual reduction of the wage index PPS. In the CY 2013 ESRD PPS the statement in the CY 2012 final rule floor during the transition; and the proposed rule, we did not propose any that ‘‘For rural Massachusetts, we policies for areas with no hospital data. changes to the wage index floor determined that the borders of Dukes For CY 2013, we did not propose any methodology or reduction. and Nantucket Counties are contiguous changes to the methodology finalized in Consequently, for CY 2013 we indicated with Barnstable and Bristol counties. the CY 2012 final rule and will update in the proposed rule that we would Under the methodology, the values for the wage index values using the FY continue to reduce the wage index floor these counties are averaged to establish 2013 Inpatient Prospective Payment by 0.05, which will reduce the wage the wage index value for rural System (IPPS) pre-floor, pre-reclassified index value for the wage index floor Massachusetts’’ (76 FR 70241). hospital wage data. from 0.550 to 0.500. For CY 2013, the Therefore, for CY 2012 and subsequent In the CY 2012 ESRD PPS final rule wage index floor of 0.500 only applies years, the area wage index value for (76 FR 70242), we explained that we to areas located in Puerto Rico because rural Massachusetts is based on wage would continue to use the labor-related those are the only areas that have wage data of the rural hospital. share of 53.711 finalized in the 2005 index values below the wage index floor For CY 2013, we will continue to use PFS final rule (70 FR 70168) for the value of 0.500. In the CY 2012 ESRD the statewide urban average based on composite rate portion of the blended PPS final rule (76 FR 70241), we the average of all urban areas within the payment during the transition and explained that continuing to artificially state for urban areas without hospital continue to use a labor-related share of adjust the wage index values after the data. We note that Yuba City, California 41.737 for the ESRD PPS payment for transition by substituting a wage index now has hospital data to calculate a CY 2012. We also discussed that the floor is not an appropriate method to wage index. Therefore, the methodology wage data used to construct the wage address low wages in certain geographic for computing a wage index for urban index under the ESRD PPS is updated locations. Therefore, we would no areas without hospital data no longer annually, based on the most current longer apply a wage index floor applies to that area. The only urban area data available and based on the Office beginning January 1, 2014. without wage index data is Hinesville- of Management and Budget’s (OMB’s) Fort Stewart, GA. urban and rural definitions and b. Policies for Areas With No Wage Data corresponding wage index values. In the CY 2012 ESRD PPS final rule c. Wage Index Budget-Neutrality Additional discussion on the labor- (76 FR 70241), we explained that we Adjustment related share can be found in section adopted the CBSA designations for the In the CY 2012 ESRD PPS final rule II.c.3 of this final rule. For CY 2013, we basic case-mix adjusted composite rate (76 FR 70241 and 70242), we explained did not propose to change the labor- payment system and for the ESRD PPS. that we have broad discretion under related shares, as finalized in the CY We also discussed and finalized the section 1881(b)(14)(D)(iv)(II) of the Act 2012 rule, as discussed in section II.C.3 methodologies we use to calculate wage to develop a geographic wage index. We of this final rule. index values for ESRD facilities that are explained that in addition to being

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given broad discretion, the section cites Rule Occupational Mix Adjusted and the wage index budget-neutrality the wage index under the basic case-mix Unadjusted Average Hourly Wage and adjustment factor is applied to the base adjusted composite payment system as Pre-Reclassified Wage Index by CBSA’’. rate. an example. We have previously To compute the CY 2013 wage index d. ESRD PPS Wage Index Tables interpreted the statutory requirement in budget-neutrality adjustment factor for section 1881(b)(12)(D) of the Act for the this final rule, we used treatment counts The CY 2013 ESRD PPS proposed geographic adjustment for the basic from the 2011 claims and facility- wage index tables, referred to as case-mix adjusted composite payment specific CY 2012 payment rates; we Addendum A (ESRD facilities located in system as requiring that the geographic computed the estimated total dollar urban areas), and Addendum B (ESRD adjustment be made in a budget-neutral amount that each ESRD facility would facilities located in rural areas) are manner. have received in CY 2012. The total of posted on the CMS Web site at http:// In the CY 2012 ESRD PPS final rule these payments became the target www.cms.gov/vESRDPayment/PAY/list. (76 FR 70241 and 70242), we finalized amount of expenditures for all ESRD asp. The wage index tables list two the policy to apply the wage index in a facilities for CY 2013. Next, we separate columns of wage index values. budget-neutral manner under the ESRD computed the estimated dollar amount One column represents the wage index PPS using a wage index budget- that would have been paid for the same values for the composite rate portion of neutrality adjustment factor. We further ESRD facilities using the final ESRD the blended payment to which the wage explained that in the first year of the wage index for CY 2013. The total of index budget-neutrality adjustment ESRD PPS, CY 2011, we did not apply these payments becomes the new CY factor has been applied. The other a wage index budget-neutrality 2013 amount of wage-adjusted column lists the wage index values for adjustment factor under the ESRD PPS expenditures for all ESRD facilities. the ESRD PPS, which does not reflect because budget-neutrality was achieved After comparing these two dollar the application of the wage index through the overall 98 percent budget- amounts (target amount divided by the budget-neutrality adjustment factor, neutrality requirement in section new CY 2013 amount), we calculated because we finalized for CY 2012 and 1881(b)(14)(A)(ii) of the Act. In the CY two wage index budget-neutrality subsequent years that we will apply the 2012 ESRD PPS final rule (76 FR 70242), adjustment factors that, when wage index budget-neutrality we finalized that for CYs 2012 and 2013 multiplied by the applicable CY 2013 adjustment factor to the ESRD PPS base we will apply the wage index budget- estimated payments, would result in rate. neutrality adjustment to the wage index aggregate payments to ESRD facilities We received one comment. The values for the composite rate portion of that would remain budget-neutral when comment and our response are set forth the blended payment and that for CY compared to the target amount of below. 2012 and subsequent years we will expenditures. The first factor was Comment: We received a comment apply the wage index budget-neutrality applied to the ESRD PPS base rate. The from an LDO that expressed concern adjustment to the ESRD PPS base rate second factor was applied to the wage about the negative impact of the wage for purposes of the ESRD PPS portion of index values for the composite rate index floor on dialysis providers in the blended payment during the portion of the blended payment. Puerto Rico. The commenter expressed transition and the ESRD PPS payment. Therefore, in this final rule, we are concern that wages for dialysis facilities We did not propose any changes to the finalizing for CY 2013, the wage index in Puerto Rico are not accurately wage index budget-neutrality budget-neutrality adjustment factor for captured by the current hospital wage adjustment methodology for CY 2013. the composite portion of the ESRD PPS index methodology. The commenter In the CY 2012 ESRD PPS final rule blended payment of 1.001141, which is urged CMS to determine an alternate (76 FR 70242), we also finalized the applied directly to the ESRD wage index basis for calculating the wage index methodology for computing the wage values. For the ESRD PPS (that is, for floor in Puerto Rico, stating that it does index budget-neutrality adjustment the full ESRD PPS payments and the not believe that the wage index as factor for CY 2012 and subsequent ESRD PPS portion of the blended reported for Puerto Rico is years. For CY 2013, we did not propose payments during the transition), we are representative of the wage levels of any changes to the methodology. finalizing the wage index budget- dialysis providers in Puerto Rico Consequently, for the CY 2013 wage neutrality adjustment factor of 1.000613 relative to a sample of other states. index budget-neutrality adjustment that will be applied to the ESRD PPS Specifically, the commenter provided factors, we use the fiscal year (FY) 2013 base rate. Because we apply the wage its own analysis of its random sampling pre-floor, pre-reclassified, non- index budget-neutrality adjustment of cost report salaries comparing ESRD occupational mix-adjusted hospital data factor to the wage index values to facilities in Puerto Rico with ESRD to compute the wage index values, 2011 ensure budget-neutrality under the facilities in Florida, Georgia, Ohio, outpatient claims (paid and processed composite rate portion of the blended South Carolina and Virginia. The as of December 31, 2011), and payment, we also apply the wage index commenter recommended that geographic location information for each budget-neutrality adjustment factor to reimbursement for Puerto Rico be based facility, which can be found through the wage index floor. We note that this on ‘‘some measure other than the Dialysis Facility Compare (DFC). The would apply to areas in Puerto Rico, hospital wage index, such as basing the DFC can be found at the Dialysis subject to the floor. Therefore, for the wage index on cost report salaries Facility Compare Web page on the composite rate portion of the blended relative to other state salaries.’’ The Medicare.gov Web site at www. payment, we are finalizing for CY 2013, commenter further explained that Medicare.gov/Dialysis. The FY 2013 to apply the wage index budget- Puerto Rico requires that only registered hospital wage index data for each urban neutrality adjustment factor to the wage nurses (RN) provide dialysis therapy, and rural locale by CBSA may also be index floor of 0.500 which results in an and therefore, in the dialysis setting, the accessed on the CMS Web site at adjusted wage index floor of 0.501 occupational mix would be weighted http://www.cms.hhs.gov/ (1.001141 × 0.500) because under the more toward RNs than the mix for AcuteInpatientPPS/WIFN/list.asp. The composite rate, the wage index budget- hospital. wage index data are located in the neutrality adjustment is applied to the Response: We understand that the section entitled, ‘‘FY 2013 Proposed wage index value. Under the ESRD PPS, commenter is concerned about wage

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index values in Puerto Rico, however, it drug or biological that may be commenter encouraged CMS to consider is our policy to use wage indices for all developed in the future. the appropriateness of other anti- ESRD facilities that are based on the In the CY 2012 ESRD PPS final rule infective drugs and biologicals which IPPS pre-floor, pre-reclassified hospital (76 FR 70243), we explained that could be used in the future for both wage data. We discuss this in detail subsequent to the publication of the CY ESRD and non-ESRD conditions, with above. We believe that this is an 2011 ESRD PPS final rule, we received the primary goal to help reduce drug appropriate mechanism for obtaining numerous comments indicating that resistance in this compromised and wage index values to be used to vancomycin is indicated in the susceptible patient population. geographically adjust the ESRD PPS treatment of both ESRD and non-ESRD Response: We thank the commenters base rate for all ESRD facilities. It has conditions, such as skin infections. In for their support. We believe that the been the same method that we have the CY 2012 ESRD PPS final rule (76 FR commenter is suggesting that CMS used previously for the basic case-mix 70243), we allowed ESRD facilities to should frequently consider whether adjusted composite rate payment receive separate payment for other drugs should be included in the system. We refer the commenter to the vancomycin when furnished to treat ESRD PPS. We will consider allowing discussion on the methodology used to non-ESRD related conditions. When separate payment for other anti-infective determine wage index values in the CY ESRD facilities furnish vancomycin to drugs and biologicals as we may 2013 IPPS final rule (77 FR 53365 treat non-ESRD related conditions, they determine appropriate. through 55367). We will, however, place the AY modifier on the claim. We We are finalizing the proposal to consider the commenter’s recommended stipulated that in accordance with ICD– eliminate the restriction on daptomycin approach if we determine in the future 9–CM guidelines as described in the CY to allow ESRD facilities to receive that a change to the methodology for 2011 ESRD PPS final rule (75 FR 49107), separate payment by placing the AY determining geographic wage index an ESRD facility must report on the modifier on the claim for daptomycin values is warranted. claim the diagnosis code for which when furnished to treat non-ESRD vancomycin is indicated. We also related conditions. In accordance with In the CY 2012 ESRD PPS proposed reiterated that treatment of any skin ICD–9–CM diagnostic coding guidelines rule (76 FR 40509 and 40510), we infection that is related to renal dialysis as described in the CY 2011 ESRD PPS proposed to continue to reduce the wage access management would be final rule (75 FR 49107), the ESRD index floor by 0.50 for each of the considered a renal dialysis service paid facility must indicate on the claim the remaining years of the transition (that is, under the ESRD PPS, and that no diagnosis code for which the CYs 2012 and 2013). We also stated that separate payment would be made (76 FR daptomycin is indicated. ‘‘we continue to believe that artificially 70243). Finally, in response to During our monitoring of claims we adjusting wage index values by comments, we stated that we would have noted that there are ESRD facilities substituting a wage index floor is not an consider allowing separate payment for that are indicating a type of organism appropriate method to address low daptomycin (76 FR 70243). rather than a diagnosis that would wages in certain geographic locations’’ In the CY 2013 ESRD PPS proposed indicate that the anti-infective was and that, accordingly, we will no longer rule (77 FR 40963), we explained that furnished for non-ESRD-related apply a wage index floor beginning after consultation with our medical conditions. We reiterate that the January 1, 2014 (76 FR 70241). We will experts, we proposed to allow ESRD diagnosis code for which vancomycin or include in the CY 2014 ESRD PPS facilities to receive separate payment for daptomycin is used must be indicated proposed rule, the methodology we daptomycin when furnished to treat on the claim. We also reiterate that propose to use to address wages in rural non-ESRD related conditions for CY treatment of any skin infection that is Puerto Rico when we no longer apply 2013 and subsequent years. When ESRD related to renal dialysis access the wage index floor. facilities furnish daptomycin to treat management will be considered a renal Therefore, we are finalizing the wage non-ESRD-related conditions, they dialysis service and will continue to be index floor value of 0.500 for CY 2013. would place the AY modifier on the paid under the ESRD PPS, and no claim. We also explained that if ESRD separate payment will be made. We will 6. Drug Policy Changes facilities submitted claims for continue to monitor the use of anti- a. Daptomycin daptomycin with the AY modifier, then infectives furnished by ESRD facilities the ESRD facility would also be required including those that are identified as In the CY 2011 ESRD PPS final rule to report the diagnosis code for which non-ESRD related to ensure proper (75 FR 49050 through 49052), we stated the daptomycin is indicated in billing of these drugs. that antibiotics used for the treatment of accordance with ICD–9–CM diagnostic b. Alteplase and Other Thrombolytics vascular access infections and coding guidelines. We sought public peritonitis are renal dialysis services comments on our proposal to permit In the CY 2012 ESRD PPS final rule under the ESRD PPS. Payments for anti- separate payment for daptomycin when (76 FR 70246 through 70247), we infective drugs in injectable forms furnished to treat non-ESRD-related explained that after the CY 2011 ESRD (covered under Part B) and oral or other conditions. As we discussed in the PPS final rule was published, our forms of administration (formerly proposed rule, we will continue to clinical review of the 2007 ESRD claims covered under Part D) used for the monitor the use of anti-infectives used to develop the ESRD PPS revealed treatment of ESRD, were included in furnished by ESRD facilities including that dialysis facilities routinely used computing the final ESRD PPS base rate those that are identified as non-ESRD alteplase and other thrombolytic drugs and, therefore, would not be separately related (77 FR 40963). The comments for access management purposes. We paid under the ESRD PPS. We further we received and our responses are set explained that under the Medicare stated that any anti-infective drug or forth below. Benefit Policy Manual, Pub. 100–02, biological used for the treatment of Comment: We received eight chapter 11, section 30.4.1, drugs used as ESRD-related conditions would be comments in support of our proposal to a substitute for any of the listed items considered a renal dialysis service and allow for separate payment for or used to accomplish the same effect not eligible for separate payment. We daptomycin when furnished for non- were covered under the composite rate. noted that this policy also applies to any ESRD related conditions. One We further explained that because

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heparin is a composite rate drug and rate portion of the blended payment in composite rate drug and thrombolytics could be used for access management, CY 2013. In general, commenters agreed are used to achieve the same renal any drug or biological used for the same with CMS that both heparin and dialysis-related clinical outcome, we purpose may not be separately paid. alteplase or other thrombolytic drugs are believe it is appropriate to exclude Medicare regulations at 42 CFR used for access management, but a few thrombolytic drugs from separate 413.237(a)(2) through (a)(6), and (b) commenters disagreed with our payment under the composite rate specify the methodology used to assertion that heparin and alteplase are portion of the blended payment during calculate outlier payments. An ESRD used for the same purpose. Some the transition. facility is eligible for an outlier payment commenters specifically noted that Comment: One ESRD facility if its actual or imputed Medicare CMS’s proposal not to allow separate commented that the high cost of Allowable Payment (MAP) amount per payment for alteplase and thrombolytic alteplase compared to heparin would treatment for ESRD outlier services drugs under the composite rate portion prevent substitution of alteplase for exceeds a threshold. The MAP amount of the blended payment during the heparin. The commenter argued that represents the average incurred amount transition period for CY 2013 is flawed CMS’s policy in the ESRD Benefit Policy per treatment for services that were or because the drugs are used to achieve Manual, Pub. 100–02, chapter 11, would have been considered separately different clinical results and utilize section 30.4.1 of covering under the billable services prior to January 1, different mechanisms of action. In composite rate drugs used as substitutes 2011. The discussion on the outlier particular, the commenters noted that for composite rate drugs, or used to policy is in section II.C.7 of this final heparin is used to prevent clotting accomplish the same effect, is without rule. Section 413.237(a)(1) provides the whereas alteplase is used to avoid a regard to innovation, cost, effectiveness, definition of ESRD outlier services. poorly functioning catheter. Some and efficiencies, and may result in Specifically, § 413.237(a)(1)(i) includes commenters provided examples of the increased cost to the Medicare program. ‘‘ESRD related drugs and biologicals efficacy of alteplase and thrombolytics, The commenter also noted that the cost that were or would have been, prior to as compared to heparin. Some of thrombolytics is included in the January 1, 2011, separately billable commenters, including a renal ESRD PPS for those not in the transition under Medicare Part B.’’ organization and a pharmaceutical and that elimination of separate Because outlier payments are manufacturer, disagreed that heparin payment for those in the transition restricted under § 413.237(a) to those can be used as a substitute for alteplase, would negatively impact items or services that were or would citing the different mechanisms of reimbursement. A pharmaceutical have been separately billable prior to action for the two drugs. One company stated that the proposed January 1, 2011, in the CY 2012 ESRD commented that because heparin and changes may negatively affect catheter PPS final rule (76 FR 70249), we thrombolytics achieve different clinical care because disallowing outlier excluded thrombolytic drugs from the results, they should not be treated as payments and separate payment for outlier policy and we recomputed the substitutes for payment purposes. thrombolytics creates a financial outlier MAP amounts to reflect this incentive for facilities to avoid restoring change. However, we noted in the CY Response: We believe alteplase and patency with alteplase. 2012 ESRD PPS final rule (76 FR 70249), heparin are used for the same renal Response: In the CY 2012 ESRD PPS that for CY 2012 we had not proposed dialysis-related purpose, namely, final rule (76 FR 70247), we explained to exclude separate payment of vascular access management. In the CY that the ESRD PPS provides an thrombolytic drugs under the composite 2012 ESRD PPS final rule (76 FR 70246 opportunity for ESRD facilities to make rate portion of the blended payment and through 70249), we addressed similar decisions based on the medical needs of therefore, separate payment would be comments regarding the use of alteplase patients and not on the basis of financial made for thrombolytics for the and heparin in the context of our gain. We further explained that we are composite rate portion of the blended proposal to eliminate thrombolytics not implying that thrombolytics or any payment in CY 2012. from the outlier policy. We noted that access management drug should not be For CY 2013, we proposed that in the development of the ESRD PPS, used when clinically indicated. We thrombolytic drugs would not be we recognized that alteplase and noted that Medicare payment policy is considered eligible for separate payment heparin were pharmacologically not intended to dictate, determine, or under the composite rate portion of the different (that one is a thrombolytic that influence clinical practice or favor one blended payment for those ESRD lyses clots and the other is an course of treatment over another. facilities that are receiving a blended anticoagulant that prevents clots, Rather, by accounting in the ESRD PPS payment under the transition (77 FR respectively) (76 FR 70248). We further base rate for the cost of drugs and 40963). We believe that this is stated, however, that we believed that biologicals that had been separately consistent with the changes we made to both drugs enable the catheter or graft payable under the composite rate our outlier policy regarding excluding to function either through clot system, we believe that we provide thrombolytic drugs from outlier prevention or clot degradation, thereby adequate payment to maintain patency eligibility as discussed above. We note providing effective dialysis vascular of the access site regardless of whether that these conclusions are specific to access. We further believe that, for patency is maintained using heparin or ESRD. We solicited comments on our purposes of payment for renal dialysis a thrombolytic. For additional proposal to exclude thrombolytic drugs services, it is sufficient that these information regarding this issue, we from separate payment under the products can be used for the purpose of refer the commenters to the comment composite rate portion of the blended providing dialysis vascular access. responses in the CY 2012 ESRD PPS payment during the transition. Consistent with the ESRD Benefit Policy final rule (76 FR 70247 through 70249). The comments and our responses are Manual, Pub. 100–02, chapter 11, We disagree with the commenter that set forth below. section 30.4.1, drugs used as substitutes ESRD facilities receiving blended Comment: We received five comments for any of the listed items, or used to payments during the transition are pertaining to our proposal to no longer accomplish the same effect, are covered unfairly disadvantaged because they provide separate payment for under the composite rate and are not will not receive separate payment for thrombolytic drugs under the composite separately payable. Because heparin is a thrombolytics for the portion of the

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blended payment based on the purposes, as updated in the PFS rule or January 14, 2011 which was issued to composite rate. Even when the in updating the ASP pricing. Therefore, correct the subject on the Transmittal composite rate system was in place we are finalizing that for CY 2013 and page and made no other changes. before the ESRD PPS was implemented, subsequent years we will continue to In the CY 2012 ESRD PPS final rule it was our policy not to pay separately use the ASP methodology, including (76 FR 70246), we finalized our for drugs that could be used to any modifications finalized in the proposal to stop issuing a specific list of accomplish the same effect as composite Physician Fee Schedule (PFS) final eligible outlier service drugs which rate drugs. Accordingly, it is consistent rules, to compute outlier MAP amounts, were or would have been separately with that policy not to provide separate the drug add-on, and any other policy billable under Medicare Part B prior to payment for thrombolytics for the that requires the use of payment January 1, 2011. We stated in that rule composite rate portion of blended amounts for drugs and biologicals that that we planned to use separate payments during the remainder of the would be separately paid absent the guidance to continue to identify renal transition. ESRD PPS and for the composite rate dialysis service drugs which were or For all of the reasons stated above, we portion of the blended payment during would have been covered under Part D continue to believe that alteplase and the transition. for outlier eligibility purposes in order other thrombolytics should not be to provide unit prices for calculating eligible for separate payment under the 7. Revisions to the Outlier Policy imputed outlier services. In the CY 2013 composite rate portion of the blended Section 1881(b)(14)(D)(ii) of the Act ESRD PPS proposed rule (77 FR 40964), payment. After consideration of public requires that the ESRD PPS include a we explained that we planned to comments, we are finalizing our CY payment adjustment for high cost identify, through our monitoring efforts, 2013 proposal to exclude alteplase and outliers due to unusual variations in the those items and services that are other thrombolytics from separate type or amount of medically necessary incorrectly being identified as eligible payment, which we believe is consistent care, including variability in the amount outlier services. Any updates to the list with the CY 2012 ESRD PPS changes of erythropoiesis stimulating agents of renal dialysis items and services that made to the outlier policy to exclude (ESAs) necessary for anemia qualify as outlier services will be made thrombolytic drugs from outlier management. Our regulations at 42 CFR through administrative issuances, if payments. 413.237(a)(1) provide that ESRD outlier necessary. services include: (i) ESRD-related drugs We indicated in the CY 2013 ESRD c. Part B Drug Pricing and biologicals that were or would have PPS proposed rule (77 FR 40964), that In the CY 2011 ESRD PPS proposed been, prior to January 1, 2011, Medicare regulations at 42 CFR rule (74 FR 49991), with respect to separately billable under Medicare Part 413.237(a)(2) through (a)(6), and (b) estimating the imputed MAP amounts of B; (ii) ESRD-related laboratory tests that specify the methodology used to ESRD outlier services that are separately were or would have been, prior to calculate outlier payments. We billable under Part B, we proposed to January 1, 2011, separately billable explained that an ESRD facility is use Average Sales Price (ASP) data for under Medicare Part B; (iii) medical/ eligible for an outlier payment if its Part B ESRD-related drugs (which is surgical supplies, including syringes actual or imputed Medicare Allowable updated quarterly). We did not make used to administer ESRD-related drugs, Payment (MAP) amount per treatment any changes to this proposed that were or would have been, prior to for ESRD outlier services exceeds a methodology in the CY 2011 final rule. January 1, 2011, separately billable threshold. We further explained that the In the CY 2012 ESRD PPS final rule (76 under Medicare Part B; and (iv) renal MAP amount represents the average FR 70243), we explained that ESRD dialysis service drugs that were or incurred amount per treatment for facilities receiving blended payments would have been, prior to January 1, services that were or would have been under the transition would receive 2011, covered under Medicare Part D, considered separately billable services payments based on ASP for separately excluding ESRD-related oral-only drugs. prior to January 1, 2011. We also stated billable ESRD drugs and biologicals for In the CY 2011 ESRD PPS final rule, that the threshold is equal to the ESRD the composite rate portion of the blend. we stated that for purposes of facility’s predicted ESRD outlier In the CY 2012 ESRD PPS final rule (76 determining whether an ESRD facility services MAP amount per treatment FR 70244), we stated that under the would be eligible for an outlier (which is case-mix adjusted) plus the outlier policy, we will use the ASP payment, it would be necessary for the fixed dollar loss amount. Finally, we methodology. facility to identify the actual ESRD explained that in accordance with 42 In the CY 2013 ESRD PPS proposed outlier services furnished to the patient CFR 413.237(c), facilities are paid 80 rule (77 FR 40963), we proposed for CY by line item on the monthly claim (75 percent of the per treatment amount by 2013 and subsequent years to continue FR 49142). which the imputed MAP amount for to use the ASP methodology, including In the CY 2013 ESRD PPS proposed outlier services (that is, the actual any modifications finalized in the PFS rule (77 FR 40964), we explained that incurred amount) exceeds this threshold final rules, to compute our outlier MAP drugs, laboratory tests, and medical/ and that ESRD facilities are eligible to amounts, the drug add-on, and any surgical supplies that we would receive outlier payments for treating other policy that requires the use of recognize as outlier services are both adult and pediatric dialysis payment amounts for drugs and specified in Attachment 3 of Change patients. biologicals that would be separately Request 7064, Transmittal 2033 issued In the CY 2011 ESRD PPS final rule, paid absent the ESRD PPS and for the August 20, 2010 and rescinded and using 2007 data, we established the composite rate portion of the blended replaced by Transmittal 2094, dated outlier percentage at 1.0 percent of total payment during the transition. We November 17, 2010. We also explained payments (75 FR 49142 through 49143). explained that we would use this that with respect to the outlier policy, We also established the fixed dollar loss methodology for payment analyses that Transmittal 2094 identified additional amounts that are added to the predicted CMS may perform. We did not receive drugs and laboratory tests that may be outlier services MAP amounts. The public comments on our proposal to eligible for ESRD outlier payment. outlier services MAP amounts and fixed apply the ASP methodology or any Transmittal 2094 was rescinded and dollar loss amounts are different for modifications to the ASP for these replaced by Transmittal 2134, dated adult and pediatric patients due to

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differences in the utilization of based on pre-ESRD PPS claims data and explained that we were updating the separately billable services among adult utilization. outlier services MAP amounts and fixed and pediatric patients (75 FR 49140). Comment: Several commenters agreed dollar loss amounts to reflect the As we explained in the CY 2011 ESRD that no changes need to be made to the utilization of outlier services reported PPS final rule (75 FR 49138 and 49139), methodology and commended CMS for on the 2011 claims using the December the predicted outlier services MAP its transparency regarding the data and 2011 claims file. In this final rule, for amounts for a patient would be methodology used to update the MAP CY 2013, we used the June 2012 update determined by multiplying the adjusted and fixed dollar loss thresholds. Some of the CY 2011 National Claims History average outlier services MAP amount by commenters expressed appreciation of File to update the outlier services MAP the product of the patient-specific case- CMS’s clear explanation of eligible amounts and fixed dollar loss amounts. mix adjusters applicable using the outlier services. That is, for CY 2013, the MAP and fixed outlier services payment multipliers Response: We thank the commenters dollar loss amounts are based on developed from the regression analysis for their support. We will continue to utilization data from the 2011 ESRD PPS to compute the payment adjustments. issue guidance regarding the renal claims. For this final rule, the impact of The average outlier services MAP dialysis items and services that could this update is shown in Table 1, which amount per treatment for CY 2011 was qualify for outlier payment. compares the outlier services MAP based on payment amounts reported on amounts and fixed dollar loss amounts 2007 claims and adjusted to reflect a. Impact of Changes to the Outlier used for the outlier policy in CY 2012 projected prices for 2011. For CY 2012, Policy with the updated estimates. The the outlier services MAP amounts and In the CY 2013 ESRD PPS proposed estimates for the CY 2013 outlier policy, fixed dollar loss amounts were based on rule (77 FR 40964), we explained that which are included in Column III of 2010 data (76 FR 70250). That is, for we did not propose any changes to the Table 1, were inflation-adjusted to CYs 2011 and 2012, the MAP and fixed methodology used to compute the MAP reflect projected 2013 prices for outlier dollar loss amounts were computed or fixed dollar loss amounts. Rather, we services.

TABLE 1—OUTLIER POLICY: IMPACT OF USING UPDATED DATA TO DEFINE THE OUTLIER POLICY

Column I Column II Column III Outlier policy for CY2012 Updated outlier estimates Final outlier policy for (based on 2010 data price based on 2011 data price CY2013 (based on 2011 inflated to 2012) * inflated to 2012 * data price inflated to 2013) * Age Age Age Age Age Age < 18 > = 18 < 18 > = 18 < 18 > = 18

Average outlier services MAP amount per treatment 1 ... $46.26 $81.73 $37.84 $59.49 $38.65 $61.38 Adjustments Standardization for outlier services 2 ...... 1.0024 0.9738 1.0927 0.9878 1.0927 0.9878 MIPPA reduction...... 0.98 0.98 0.98 0.98 0.98 0.98 Adjusted average outlier services MAP amount 3 .... $45.44 $78.00 $40.52 $57.59 $41.39 $59.42 Fixed dollar loss amount that is added to the predicted MAP to determine the outlier threshold 4 ...... $71.64 $141.21 $44.16 $103.47 $47.32 $110.22 Patient months qualifying for outlier payment ...... 5.7% 5.4% 7.8% 5.2% 7.6% 5.1% * The outlier services MAP amounts and fixed dollar loss amounts were inflation adjusted to reflect updated prices for outlier services (that is, 2012 prices in Columns I and II and projected 2013 prices in Column III). 1 Excludes patients for whom not all data were available to calculate projected payments under an expanded bundle. The outlier services MAP amounts are based on 2011 data. The medically unbelievable edits of 400,000 units for epoetin and 1,200 mcg for Aranesp that are in place under the ESA claims monitoring policy were applied. 2 Applied to the average outlier MAP per treatment. Standardization for outlier services is based on existing Case Mix Adjusters for adult and pediatric patient groups. 3 This is the amount to which the separately billable (SB) payment multipliers are applied to calculate the predicted outlier services MAP for each patient. 4 The fixed dollar loss amounts were calculated using 2011 data to yield total outlier payments that represent 1% of total projected payments for the ESRD PPS.

As seen in Table 1, the estimated The fixed dollar loss amounts which We estimate that the percentage of fixed dollar loss amounts that determine are added to the predicted MAP patient months qualifying for outlier the 2013 outlier threshold amounts amounts per treatment to determine the payments under the current policy will (Column III) are lower than those used outlier thresholds are being updated be 5.1 percent and 7.6 percent for adult for the 2012 outlier policy (Column I). from the CY 2012 amount. Based on the and pediatric patients, respectively, The main reason for these reductions is use of the most recently available data, based on our use of 2011 data. The the lower utilization of epoetin and the fixed-dollar loss amount for pediatric outlier MAP and fixed dollar other outlier services in CY 2011, the pediatric patients will decrease from loss amounts continue to be lower for first year of the PPS. This can be seen $71.64 to $47.32 and the MAP amount pediatric patients than adults due to the by comparing the outlier service MAP will decrease from $45.44 to $41.39 as continued lower use of outlier services amounts in Column I (which are based compared to CY 2012 values. For adult (primarily reflecting lower use of on 2010 data) with the outlier service patients, the fixed-dollar loss amount epoetin and other injectable drugs). MAP amounts in Column II (which are drops from $141.21 to $110.22 and the Comment: All of the commenters based on 2011 data). MAP amount drops from $78.00 to supported CMS’s decision to lower the $59.42. threshold for both the fixed dollar loss

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and MAP amounts for pediatric and volume of ESRD patients. Although we facilities. One commenter suggested that adult patients. The commenters stated will continue to monitor the impact of CMS set less than 1 percent aside for that they believed that outlier payment our outlier policy, as noted above, we outliers and allocate the leftover funds mechanisms are fundamental to the believe that all facilities, regardless of to the ESRD PPS base rate. long-term success of prospective size, should be able to identify outlier Response: We disagree that the payment systems to ensure patients get services on claims and be compensated shortfall in outlier payments should be the care they need, even when there are for the cost of treating beneficiaries with used to make additional payments to financial disincentives. The commenters high resource utilization. ESRD facilities to account for not further expressed that it is important for achieving the 1 percent threshold. The b. Outlier Policy Percentage CMS to ensure that the information it 1 percent outlier policy is a prospective uses to determine the outlier thresholds In the CY 2013 ESRD PPS proposed payment mechanism in which each year is as current as possible and rule (77 FR 40965), we explained that 42 thresholds are established and adjusted agreed with CMS in using the 2011 CFR 413.220(b)(4) stipulates that the per on a yearly basis based on historical ESRD claims and utilization for CY treatment base rate is reduced by 1 data. In the FY 1997 Inpatient 2013. percent to account for the proportion of Prospective Payment System (IPPS) Response: We thank the commenters the estimated total payments under the final rule (61 FR 46229 and 46230), we for their support. ESRD PPS that are outlier payments. We explained that we believe our outlier Comment: Several commenters further explained that because of the policies are consistent with the statute expressed concern that some ESRD decrease in utilization associated with and the goals of the prospective facilities may not have the necessary the implementation of the ESRD PPS, payment system. Many of the factors resources available to identify outlier the 1 percent target for outlier payments used to set prospective payment services on the claim, and therefore are was not achieved in CY 2011. For this amounts for a given year are based on not receiving the outlier payments to final rule, using the June 2012 update of estimates. These factors include not which they are entitled. One commenter the CY 2011 National Claims History only the outlier thresholds, but also the suggested that CMS make available data File, we found that outlier payments market basket rate of increase, the indicating that the outlier policy is represented approximately 0.3 percent update factors and the required budget- beneficial to small ESRD facilities. The of total payments. That is, the historical neutrality provisions. We do not believe commenter further explained that this data previously used to set the outlier that Congress intended that the policy could be detrimental to small thresholds for CY 2011 projected greater standardized amounts should be facilities because, although the facilities’ use of outlier services than was adjusted (upward or downward) to base rate is reduced by 1 percent to observed under the expanded ESRD reflect differences between projected account for outlier services, the facilities PPS, leading to lower outlier payments and actual outlier payments for a given may be unable recoup this amount than expected. Use of 2011 data to year. Moreover, retroactive adjustments because of resource limitations. recalibrate the thresholds, reflecting would be extremely difficult or Response: Outlier services are the lower utilization of epoetin and other impracticable (if not impossible) to items and services that were separately outlier services, will result in aggregate administer. We further explained that paid prior to the implementation of the outlier payments close to the 1 percent the thresholds for a given year reflect ESRD PPS and are also separately paid target in CY 2013. We believe this certain levels of costs, so that if costs are under the composite rate portion of the update to the outlier MAP and fixed held down, fewer cases qualify for blended payment for those ESRD dollar loss amounts for CY 2013 will outlier payments and outlier payments facilities under the transition. We do not increase payments for ESRD are lower than expected. We believe that believe that it should be difficult for beneficiaries requiring higher resource the same explanation applies to the small facilities to identify outlier utilization in accordance with a 1 ESRD PPS. services on claims because these percent outlier policy. facilities should have had experience We note that recalibration of the fixed D. Clarifications Regarding the ESRD identifying these items on claims before dollar loss amounts in this final rule for PPS the PPS was implemented. Specifically, CY 2013 outlier payments results in no 1. Reporting Composite Rate Items and the items eligible for outlier payments change in payments to ESRD facilities under the ESRD PPS are the same items for beneficiaries with renal dialysis Services that had been separately paid under the items and services that are not eligible In the CY 2011 ESRD PPS final rule basic case-mix adjusted composite rate for outlier payments, but raises (75 FR 49036), we explained that system and are separately paid under payments to providers for beneficiaries section 1881(b)(14)(B)(i) of the Act the composite rate portion of the with renal dialysis items and services requires that the ESRD PPS payment blended payment for ESRD facilities that are eligible for outlier payments. bundle include composite rate items receiving payment under the transition. Therefore, beneficiary co-insurance and services. The basic case-mix Consequently, we believe that obligations would increase for renal adjusted composite payment system identifying items eligible for outlier dialysis services eligible for outlier represented a limited PPS for a bundle payment is not an additional burden nor services and would remain unchanged of routine outpatient maintenance renal do we believe that it is difficult for for those not eligible. dialysis services. We defined composite small ESRD facilities. Comment: One commenter rate services at § 413.171 as ‘‘items and In terms of demonstrating that the recommended that CMS estimate and services used in the provision of outlier policy is beneficial to small publish the amount of the shortfall in outpatient maintenance dialysis for the ESRD facilities, we note that the outlier outlier payments paid during CY 2011. treatment of ESRD and included in the policy is intended to account for the The commenters recommended that composite payment system established cost of beneficiaries with high resource CMS develop a mechanism to return under section 1881(b)(7) [of the Act] and utilization; it is not intended to account these funds to the ESRD facilities so that the basic case-mix adjusted composite for facility size. Instead, our low-volume these funds may be used to offset the payment system established under adjustment accounts for facility size by costs associated with numerous section 1881(b)(12) of the Act.’’ In 42 adjusting for the cost of treating a low ‘‘unfunded mandates’’ imposed on these CFR 413.171 we also defined renal

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dialysis services as including, ‘‘items furnished in the home to treat access and supplies on claims will be required and services included in the composite site infections and peritonitis would be to be reported, we will discuss this rate for renal dialysis services as of eligible for outlier payment (76 FR requirement in future rulemaking (77 FR December 31, 2010.’’ We further 70246). In the CY 2013 ESRD PPS 40966). explained that currently services that proposed rule (77 FR 40963), we We received one comment on this are billed on the ESRD claim do not proposed to allow for separate payment issue. The comment and our response provide any detail of the composite rate for daptomycin if furnished for non- are set forth below. items and services that are furnished to ESRD-related conditions and finalized Comment: One commenter concluded the patient. We indicated that, as we in section II.C.6.2 of this final rule. that any action to recoup inappropriate discussed in the Medicare Claims As described at 42 CFR 413.239, there and duplicative payments for reporting Processing Manual, Pub. 100–04, are ESRD facilities receiving composite rate items and services chapter 8, sections 50.1 and 50.2, reimbursement under the transition, should be pursued on a going forward laboratory tests and drugs covered that is, receiving a blended payment of basis rather than retrospectively. under the facility’s composite rate may the basic case-mix adjusted composite Response: CMS has a fiduciary not be billed separately (75 FR 49173). rate payment system and the ESRD PPS. responsibility to ensure that accurate We stated in the CY 2013 ESRD PPS If an ESRD facility receives payment payments are made. If we were to proposed rule that the composite rate under the transition and reports a drug, identify inappropriate payments that represented the routine items and biological, or laboratory test that was had been made because composite rate services provided to Medicare included in the composite rate on the items and services were reported on beneficiaries for outpatient maintenance ESRD claim, it could inadvertently claims for the purpose of receiving dialysis and therefore was full payment receive separate payment for that item separate payment we would pursue for those items and services. Therefore, or service within the portion of the recoupment of those payments in it would not have been appropriate for blended payment that is based on the accordance with applicable laws and ESRD facilities to bill for items and basic case-mix adjusted composite regulations. services in the composite rate because payment system. 2. ESRD Facility Responsibilities for this would result in duplicate payments As mentioned above and defined at 42 ESRD-Related Drugs and Biologicals by Medicare (77 FR 40965). CFR 413.237, ESRD-related drugs, We also explained in the CY 2011 biologicals, and laboratory tests that In the CY 2013 ESRD PPS proposed ESRD PPS final rule (75 FR 49048), that were or would have been separately rule (77 FR 40966), we indicated that we in our analysis of the ESRD claims we payable under the basic case-mix had become aware that some ESRD identified drugs and biologicals that adjusted composite payment system facilities are requiring ESRD were included in the composite qualify as eligible outlier services. In the beneficiaries to purchase renal dialysis payment rate but for which ESRD CY 2012 ESRD PPS final rule (76 FR drugs from the ESRD facility and are facilities received separate payment in 70246), we finalized that as of CY 2012, instructing beneficiaries not to use their addition to the composite rate payment. we would no longer issue a specific list Part D plan for their purchases. We Because these composite rate drugs and of eligible outlier service drugs which explained that section 1866(a)(1)(A) of biologicals were listed separately on the were or would have been separately the Act, as codified in regulations at 42 ESRD claims, separate payment was billable under Medicare Part B prior to CFR 489.21, prohibits providers from inadvertently made. We further January 1, 2011. If an ESRD facility billing beneficiaries for services for explained that we excluded those reports a drug or biological that was which the beneficiary would have been inadvertent payments from the final included in the basic case-mix adjusted entitled to have payment made under ESRD PPS base rate calculation. We also composite payment system on the ESRD Medicare if the provider appropriately noted that the Medicare Benefit Policy claim, it would inappropriately be filed claims for those services. Manual, Pub. 100–02, chapter 11, applied toward an outlier calculation Furthermore, section 1881(b)(2)(A) of section 30.4.1 lists the drugs and fluids because all drugs and biologicals with a the Act states that payments shall be that were included under the composite rate available on the ASP pricing file made to an ESRD facility only if it payment system and explicitly states, when the modifier AY is not present agrees to accept such payments as ‘‘* * * drugs used in the dialysis may be eligible for outlier consideration. payment in full for covered services procedure are covered under the We explained in the CY 2013 ESRD except for the beneficiary co-insurance facility’s composite rate and may not be PPS proposed rule, that as a result of and deductible amounts. billed separately. Drugs that are used as our monitoring efforts, we continue to Furthermore, in the CY 2011 ESRD a substitute for any of these items, or are find composite rate drugs reported on PPS final rule (75 FR 49045), we used to accomplish the same effect, are ESRD claims and reiterated that explained that the ESRD PPS bundled also covered under the composite rate.’’ composite rate items and services are base rate reflects Medicare payment for The manual further provides that not to be reported on the ESRD facility the average ESRD patient. We stated that ‘‘administration of these items (both the claims. We noted that we are instituting we had incorporated payments under staff time and supplies) is covered measures to ensure that composite rate the basic case-mix adjusted composite under the composite rate and may not drugs are prevented from being applied rate payment system as well as be billed separately’’ (75 FR 49048). to the outlier payment. These measures payments for separately billable items In the CY 2012 ESRD PPS final rule will be discussed through and services into the ESRD PPS base (76 FR 70243), with regard to administrative issuances, as rate. As a result, we believe the ESRD antibiotics, we provided for separate appropriate. We also noted that we PPS payments are sufficient and reflect payment for vancomycin when would continue to monitor the reporting the average cost of providing care to the furnished to treat non-ESRD related of composite rate items and services on average patient with ESRD and conditions. We also eliminated the ESRD claims and plan to take actions to therefore, we expect that, on average, payment distinction for antibiotics recoup inappropriate and duplicative high cost patients would be offset by furnished in an ESRD facility or in the payments. Finally, we noted that if the low cost patients. In the CY 2011 ESRD home used to treat access infections or inclusion of composite rate items and PPS final rule (75 FR 49045), we also peritonitis. We finalized that antibiotics services such as laboratory tests, drugs explained that we had provided for

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higher acuity patients with patient case- We received no comments on the that ESRD facilities and clinical mix adjusters and outlier payments for clarification of our policy regarding laboratories are appending the AY high-cost patients. We further cited 42 ESRD facility responsibilities for ESRD- modifier for items that we believe are CFR 494.90 of the ESRD Conditions for related drugs and biologicals. ESRD-related. We noted in the proposed Coverage which requires the rule (77 FR 40967) that some ESRD 3. Use of AY Modifier development of an individualized facilities and clinical laboratories patient plan of care to address patient As we indicated in the CY 2013 ESRD appear to be appending the AY modifier needs and concluded that we believe PPS proposed rule (77 FR 40967), in the on many items and services reported on ESRD facilities should make medical CY 2011 ESRD PPS final rule, we claims. We reiterated in the proposed decisions based on patient needs and developed a mechanism to be used by rule that the purpose of the AY modifier not solely on a financial basis. ESRD facilities to identify and be paid is to allow beneficiaries the convenience In the CY 2011 ESRD PPS final rule separately for non-ESRD-related items to receive non-ESRD-related items (for (75 FR 49050), we stipulated that any and services, such as drugs, biologicals, example, drugs and laboratory tests) drug or biological (that is, injectable, and equipment and supplies (75 FR during their dialysis treatment and to oral or other forms of administration) 49052 and 75 FR 49168). We provided allow the ESRD facility to receive a furnished for the purpose of access this mechanism in order to support a separate payment for furnishing those management, anemia management, Medicare beneficiary’s need for non- items. The AY modifier is also intended vascular access or peritonitis, cellular ESRD-related items and services (that is, to allow separate payment to management or bone and mineral predominantly drugs and laboratory laboratories in the event an ESRD- metabolism would be considered renal tests) during a dialysis treatment and to related laboratory test is required for dialysis services under the ESRD PPS. mitigate the need for the beneficiary to non-ESRD-related conditions. The AY Any drug or biological used as a receive additional injections or health modifier is not intended to be used to substitute for a drug or biological that care visits. We further stated that in the receive a separate payment for items was included in the ESRD PPS bundled event that supplies or equipment are not that are ESRD-related and therefore base rate would also be a renal dialysis ESRD-related, ESRD facilities would be included in the ESRD PPS base rate. We service and would not be eligible for required to place a modifier on the further stated that we would continue to separate payment. Antiemetics, anti- claim for those supplies and equipment, monitor the use of the AY modifier and infectives, antipruritics, anxiolytic, signifying that they were used for intend to take steps to recoup excess fluid management, fluid and services that were not ESRD-related and inappropriate payments. In the event electrolyte management and pain eligible for separate payment outside of that we believe the AY modifier is not management drugs and biologicals the ESRD PPS (75 FR 49168). Change being used for the purpose intended, we could be used for dialysis purposes and Request 7064, Transmittal 2033, titled may be forced to discontinue the AY therefore, are considered ESRD-related ‘‘End Stage Renal Disease (ESRD) modifier and cease to provide separate when used for those purposes. We Prospective Payment System (PPS) and payment for any non-ESRD-related drug indicated that we presumed these drugs Consolidated Billing for Limited Part B or laboratory test furnished. and biologicals to be renal dialysis Services’’, issued on August 20, 2010, We received several comments on our services in whatever form they are re-issued November 17, 2010 under clarification of this policy and our furnished, unless indicated on the claim Transmittal 2094, and re-issued January responses are set forth below. that they are used for non-ESRD-related 14, 2011 under Transmittal 2134, Comment: We received six comments conditions. Drugs and biologicals paid provided instructions on the use of the regarding the AY modifier. Commenters under Part D that are furnished by an modifier. In that Change Request, we supported maintaining the AY modifier ESRD facility for ESRD-related purposes indicated that the claim lines for for non-ESRD conditions. Several are considered renal dialysis services laboratory tests and drugs provided to a commenters provided reasons for (75 FR 49050 and 49051). beneficiary for reasons other than the supporting the AY modifier. For In the CY 2013 ESRD PPS proposed treatment of ESRD must be submitted example, some commenters concurred rule, we reiterated that ESRD facilities with the AY modifier to signal separate that the AY modifier is intended to are responsible for furnishing renal payment outside of the ESRD PPS. In allow Medicare beneficiaries the dialysis items and services that are the CY 2012 ESRD PPS final rule, we convenience of receiving non-ESRD required to meet patient needs. This provided for the use of the AY modifier related items and services during the would include oral or other forms of with vancomycin if used for non-ESRD- course of dialysis treatment; and to administration of injectable drugs and related conditions and with the allow the ESRD facility or laboratory to biologicals that are furnished for ESRD- requirement that the ESRD facilities receive a separate payment when related conditions. We also expect that include the diagnosis code of the furnishing non-ESRD items or services. ESRD facilities will not restrict access to condition on the claim (76 FR 70243). It also enables optimal coordinated care necessary drugs for financial purposes In the CY 2013 ESRD PPS proposed rule to Medicare beneficiaries by minimizing by requiring patients to purchase (77 FR 40967), we proposed to allow the their need for additional doctor visits medically necessary drugs and use of the AY modifier for separate and duplicative or unnecessary lab tests. biologicals. We expect that ESRD payment when daptomycin is furnished Five commenters largely encouraged facilities will furnish drugs and by an ESRD facility to an ESRD CMS to continue the use of the modifier biologicals that had been considered Medicare beneficiary for non-ESRD for reporting non-ESRD related items or medically necessary prior to the related conditions. We are finalizing services for payment and to furnish implementation of the ESRD PPS and this policy above. ESRD facilities are supporting data on AY modifier misuse. not exclude them because the ESRD required to indicate an appropriate A few commenters suggested that CMS facility is now financially responsible diagnosis code on the claim that reflects should consider drafting guidance on for these drugs and biologicals. Because the condition requiring the use of the appropriate use of the AY modifier. of the reasons cited above, ESRD daptomycin. A few commenters expressed concern facilities may not require, induce or We explained in the CY 2013 ESRD over the possible elimination of the AY coerce beneficiaries to purchase any PPS proposed rule (77 FR 40967) that modifier and identified possible renal dialysis item or service. our monitoring activities have identified resulting hardships for Medicare ESRD

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beneficiaries. One commenter noted that functions to be performed by the MACs, only receive payment for 18, rather than the elimination of the AY modifier as we discussed in the CY 2013 ESRD 25, training sessions for new patients. would force facilities to send dialysis PPS proposed rule (77 FR 40967), we Response: CMS developed a patients to labs or infusion centers to are continuing to monitor the use of the reimbursement mechanism with the receive IV medications that would risk AY modifier and intend to take steps to 2011 implementation of the ESRD PPS the vascular access and add recoup inappropriate payments. that we believe supports home-based transportation and time burdens for the Although we are updating our manual, dialysis. That is, the ESRD PPS beneficiary. we believe that we have provided payment, which includes drugs, Response: We thank commenters for adequate instructions as to the laboratory tests, staff time, supplies, their support of the use of the AY appropriate use of the AY modifier. We patient-level adjustments, facility-level modifier. We agree that the elimination expect that the contractors will convey adjustments and outlier payments, is the of the AY modifier could result in information regarding the proper use of same regardless of the location where additional hardships for ESRD the AY modifier to the ESRD facilities, the dialysis services are furnished or the beneficiaries. and will also audit payments and dialysis modality, which we believe Comment: One commenter suggested request documentation as necessary. supports beneficiaries’ ability to elect to that, rather than eliminating the AY However, CMS has the responsibility to receive dialysis at home, where modifier, CMS should rely upon the ensure that payments are made appropriate. It is not, however, CMS’s contractors to educate providers, audit appropriately. Therefore, we will intent to encourage, discourage or payments for AY items, and request continue to monitor the use of the AY require any particular dialysis modality. documentation when appropriate. modifier. If we believe that the AY Rather, we believe that decisions Another commenter encouraged CMS to modifier is not being used as intended, regarding whether to receive dialysis provide data on the exact abuses or the or it is being used in order to receive and which dialysis modality to use scope of modifier misuse noting that separate payment for renal dialysis should be made by beneficiaries in patients should not suffer because of items and services that are in the consultation with their physicians. This modifier abuse, but rather CMS should bundled payment, we will be forced to includes the decision whether to receive work with facilities and providers to reconsider its use. home hemodialysis or home peritoneal ensure policy compliance. dialysis, rather than in-facility dialysis. Response: With regard to the E. Miscellaneous Comments We believe that the decision to perform suggestion that the responsibility for AY We received thirty-five comments home dialysis includes determining the modifier monitoring education should from Medicare beneficiaries, family beneficiary’s abilities, the beneficiary’s rest on the CMS contractors (that is, the members, ESRD facilities, nurses, desire to perform home dialysis and the Medicare Administrative Contractors physicians, professional organizations, beneficiary’s physical and emotional (MACs)), we note that we do provide renal organizations, and manufacturers status. education and instructions to the A/B related to issues that were not With regard to the comment asking MACs through administrative issuances specifically addressed in the CY 2013 why the payment is the same for in- and MedLearn articles that they can ESRD PPS proposed rule. facility as home dialysis, we believe that then use to educate providers. For Comment: We received comments our policy to pay the same amount, example, CMS Change Request #7064 from patients, their families, renal including the patient-level and facility- and subsequent Medicare Learning associations and manufacturers level adjustments, as well as the outlier Network Matters (MLN) article # requesting changes in how CMS pays for policy for home and in-facility dialysis, MM7064, published on January 14, home dialysis and home dialysis provides adequate payment to account 2011, notifies contractors that ESRD- training. Many of these commenters for the short-term increase in staff time related laboratory services, drugs and described the benefits of home dialysis. necessary to train beneficiaries for home supplies will be subject to Part B Most commenters asked CMS to dialysis. Training costs are included in consolidated billing edits and no longer increase the number of weekly the ESRD PPS base rate, however, we separately payable when furnished to allowable dialysis sessions and also provide an add-on adjustment for ESRD beneficiaries. However, these eliminate the medical justification each training session that represents one consolidated billing edits do not apply requirement for additional sessions. One hour of nursing time to conduct one-on- when the items and services are not commenter questioned why payment for one training treatments for each training ESRD-related. When items and services in-facility dialysis was the same as for treatment furnished by a Medicare are furnished to an ESRD beneficiary for home dialysis, noting the differences certified home dialysis training facility. conditions other than ESRD, the AY between staff and supply use between The add-on payment for one hour of modifier must be present on the claim in-facility and home dialysis. Some training per training session does not to bypass billing edits and allow for a commenters contended that patient imply that it takes only one hour per separate payment outside of the ESRD requests for home dialysis are being training session to properly educate a PPS. CMS MLN #MM7064 may be denied. Commenters also stated that beneficiary to perform home dialysis. viewed at http://www.cms.gov/ beneficiaries with ESRD are not We believe that our payment is adequate Outreach-and-Education/Medicare- provided with the same home training for training and home dialysis. Learning-Network-MLN/ opportunities as beneficiaries whose We have been and will continue to MLNMattersArticles/Downloads/ care is covered by other payment monitor and analyze trends in home MM7064.pdf. Finally, we are in the sources. Many of the commenters stated dialysis and home dialysis training. We process of updating the ESRD Benefit that payment for home dialysis training have seen a continuing increase in Policy Manual, Pub 100–02, chapter 11, is insufficient and does not reflect the overall home dialysis since mid-2009, to reflect the policy requirements under true cost of training. Some commenters including in 2011. In particular, we the ESRD PPS, including the use of the indicated various ranges of time have observed an increase in home AY modifier. required for home training in terms of hemodialysis and a decline in home With regard to the comment time per day and number of training peritoneal dialysis with an overall concerning monitoring the use of the sessions. One home dialysis higher rate of home peritoneal dialysis. AY modifier and the suggested organization stated that ESRD facilities In addition, our monitoring shows that

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ESRD facilities receive payments for for these beneficiaries. As we explained furnished at the recommended doses. more treatments for home hemodialysis in the CY 2011 ESRD PPS final rule (75 Many commenters requested that the than for in-facility hemodialysis. We FR 49094), we believe that the costs Agency share advance information also have seen an increase in home associated with the onset of dialysis about the methodology and data sources training in 2011, particularly in adjustment and the training add-on that the Agency will use to calculate the retraining. Consequently, we do not adjustment overlap (that is, costs for reimbursement rates for drugs and believe that the ESRD PPS and our services could be accounted for in both therapies and encouraged CMS to use training adjustment discourage adjustments). Accordingly, we finalized the most recent year of available data to beneficiaries from receiving home a policy that ESRD facilities will not establish a payment rate for oral-only dialysis. receive the home dialysis training drugs. Other commenters requested that Commenters also requested that we adjustment when they are receiving the CMS adopt a methodology that increase the maximum number of onset of dialysis adjustment. This does measures the actual utilization on a per dialysis sessions and eliminate the not mean that an ESRD facility may not treatment basis and includes costs medical justification requirement for furnish home training services during associated with drug administration dialysis treatments after a beneficiary the onset period. Rather, the onset of when reimbursing oral-only drugs as has received three sessions in one week. dialysis payment adjustment of 51 part of the ESRD PPS. We note that, although three is the percent per treatment accounts for the Response: We thank the commenters maximum number of sessions that we administrative and labor costs for their comments. In the CY 2011 will cover without a showing of medical associated with new patients, including ESRD PPS final rule (75 FR 49038 necessity, we will cover additional the costs to train patients. through 49044), we responded to sessions where those sessions are We are unable to address the comparable comments regarding the medically necessary. We are aware that comment contending that ESRD inclusion of oral-only drugs in CY 2014. there are observational studies that beneficiaries are not offered the same We received many suggestions from support additional weekly dialysis home dialysis training opportunities as stakeholders on how oral-only drugs treatments and that there is some those offered to ESRD beneficiaries should be included in the ESRD PPS industry support for additional covered by private payers because we bundled payment. We have reviewed treatments. We have and will continue are not familiar with these payment and will continue to review all of the to monitor and analyze the number of sources. comments, which we will consider as dialysis treatments that Medicare Comment: One patient support group we formulate our proposals on this beneficiaries receive to determine recommended that CMS use revenue issue. We intend to address the whether a change in this longstanding code 0820 when reporting home dialysis inclusion of oral-only drugs in the ESRD policy is warranted. instead of revenue code 0821, which is PPS in the CY 2014 ESRD PPS proposed In addition, in the CY 2011 ESRD PPS currently used to describe both in- rule. final rule (75 FR 49064) we stated in facility and home dialysis services. The Comment: We received three response to a MedPAC comment that we commenter contends that this will comments from industry associations would consider whether it would be correctly identify patients on home requesting that CMS release the rate- appropriate to utilize a larger unit of dialysis in Medicare claims data. setting file to allow the industry to test payment, rather than a per treatment Response: Our current Medicare the Agency’s assumptions and complete payment, after the transition period. We policy for reporting home dialysis its own analysis of the payment policies further stated that ‘‘we may evaluate services with revenue code 0821 set forth in the CY 2013 ESRD PPS whether the ERSD PPS has resulted in appended with ESRD condition code 74 proposed rule. One commenter improved outcomes, the degree to (Dialysis in the Home) allows us to encouraged CMS to make data available which home dialysis has increased, and distinguish beneficiaries receiving to the public generally, not just dialysis whether interested stakeholders would dialysis at home from those receiving facilities in particular, to allow for a favor an alternative to the per treatment treatment in an ESRD facility. more complete assessment of the ESRD approach.’’ We will continue to monitor Comment: We received twelve PPS program. the impact of the ESRD PPS and will comments regarding the Agency’s plan Response: We received comparable take these comments into consideration to include oral-only drugs in the ESRD requests and comments in response to if we determine that any changes to the PPS bundled payment for CY 2014. the CY 2012 ESRD PPS proposed rule per treatment payment approach are Commenters expressed concern about and responded to those comments in the warranted. the administrative burden, compliance CY 2012 ESRD PPS final rule (76 FR With regard to the comment that with state laws, and associated costs in 70254 to 70255). We believe that we ESRD facilities receive payment for 18 furnishing oral-only drugs within the have provided and will provide data rather than 25 training treatments for scope of the ESRD service. A few sufficient to analyze the payment new patients, we believe that the commenters requested that CMS ask for policies included in the proposed rule, commenter is confusing the adjustment community input so that the inclusion by posting the impact file for CY 2012 for beneficiaries who are receiving home of the oral-only drugs will be an on the ESRD PPS Payment Web site. We dialysis training but are not in their first uneventful transition for patients. ESRD will also post a provider-level impact four months of dialysis, with industry associations cautioned that the file and the wage index file for CY 2013 beneficiaries who have been newly inclusion of oral-only drugs into the shortly after publication of this final diagnosed with ESRD and are receiving ESRD PPS CY 2014 bundled payment rule. We also explained that we have their first four months of dialysis. The may limit patient access to the most not made the rate setting file available home dialysis training adjustment clinically appropriate drugs and ‘‘because the release of patient applies to those beneficiaries who are threaten optimal health outcomes for identifiable data is not necessary to not in their first four months of dialysis ESRD Medicare beneficiaries. Some accomplish the purpose of analyzing treatments. This adjustment does not commenters recommended that CMS our proposals. Applicable Federal apply for those beneficiaries newly include patient protections to ensure privacy laws and regulations, including diagnosed with ESRD. Instead, facilities patient care is not compromised and the Privacy Act and HIPPA Privacy Rule receive the onset of dialysis adjustment that oral-only drugs continue to be only permit us to disclose personal

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identifiable information when it is and comment rulemaking, as were the in a non-budget-neutral manner, stating necessary to administer the program, or methodologies for updating the outlier that new technologies have the potential for health care operations and threshold. In the CY 2013 ESRD PPS to lead to better diagnosis, treatment, payment.’’ proposed rule, we did not propose to and patient outcomes. Comment: We received 8 comments change how the base rate is calculated Response: We thank the commenters requesting modification to the or updated. We also did not propose in for their suggestions, but note that we standardization factor methodology and the CY 2013 ESRD PPS proposed rule to calculation for CY 2013. Many of these modify the payment adjusters. We do did not propose to implement these commenters encouraged CMS to use the not believe that because we lowered the adjusters in the CY 2013 ESRD PPS most current data available in order to MAP and fixed dollar loss amounts to proposed rule. We refer the commenters establish the standardization factor, adjust for outlier payment expenditures to the CY 2011 ESRD PPS final rule (75 rather than historical estimates. Some that were below the 1 percent target, we FR 49128 through 49134; 75 FR 49108 commenters indicated that because we must adjust the standardization factor and 49115; 75 FR 49174), in which we had adjusted the outlier fixed dollar loss for the ESRD PPS base rate. We will, explained the methodology used to and MAP amounts to account for outlier however, continue to monitor our develop the ESRD PPS for the pediatric payments below the 1 percent threshold payments and consider if any changes population, discussed the reasons for in CY 2011, we should provide a need to be made in the future. not including a patient-level case mix comparable adjustment to the Comment: One commenter requested adjuster for race, and responded to standardization factor and the ESRD clarification when billing Medicare for comments suggesting that we provide PPS base rate to account for payments Lipid Profile laboratory services separate payment for new and for patient- and facility-level adjusters furnished to ESRD beneficiaries. innovative drugs and technologies. that were not utilized. Some Another commenter encouraged CMS to commenters continue to contend that furnish guidance for blood draws and Comment: Some commenters the ESRD PPS base rate established in laboratory collections under the ESRD requested that the cost reports be CY 2011 is incorrect and that CMS PPS. amended to reflect the actual cost of should return the payment amounts Response: ESRD-related laboratory care. Some of the recommendations removed from the base rate to account tests may not be billed with the AY included that the cost report should for the adjusters, thereby increasing the modifier and no separate payment shall provide flexibility to allow for base rate. Other commenters stated that be made when an ESRD facility or innovation, eliminate the limitation on the ESRD PPS base rate should be laboratory furnishes ESRD-related medical director fees, recognize the cost adjusted to account for payments laboratory tests to an ESRD beneficiary. of supporting the ESRD networks, and allocated for the patient- and facility- We discuss laboratory tests furnished allow immediate recognition on cost level adjusters that had not ultimately under the PPS in our CY 2011 and CY reports of ‘‘new or innovative items/ been paid to the ESRD facilities. A few 2012 ESRD PPS final rules (75 FR 49053 services,’’ commenters requested that CMS modify through 49056 and 76 FR 70249 through Response: We thank the commenters the payment for case-mix and co- 70250, respectively). Furthermore, the morbidity adjustments. Lipid Profile laboratory test is for their suggestions. We plan to analyze Response: In the CY 2011 ESRD PPS appropriately included in the ESRD PPS the cost reports to determine if there are final rule, we described the data sources payment bundle when Lipid any changes required and will consider that were used in constructing the ESRD abnormalities result from, or are related the suggestions provided. PPS payment bundle, the development to the beneficiary’s ESRD. For example, We received a number of other of the ESRD PPS base rate, and the some forms of dialysis, particularly comments on a variety of topics that we payment adjusters (75 FR 49064 through peritoneal dialysis, are associated with believe are outside the scope of the 49127). In the CY 2013 ESRD PPS increased cholesterol and triglyceride proposed rule. The commenters proposed rule, we proposed to update levels, and a Lipid Profile laboratory test requested that ESRD beneficiaries be the base rate by the rate of increase in to assess these levels would be included able to maintain disability benefits the ESRD market basket, reduced by the in the bundled payment. If, however, while employed; expressed concern productivity adjustment (77 FR 40959). the Lipid Profile laboratory test is about the ‘‘corporate practice of The base rate was developed using 2007 furnished for reasons other than for the claims, in accordance with section treatment of ESRD, the laboratory medicine’’ by dialysis facilities; noted 1881(b)(14)(A)(ii) of the Act, which services may be billed with the AY that securing the necessary requires CMS to use the lowest per modifier and are eligible for separate documentation for acute co-morbidities patient utilization year. We also payment. With regard to the comment is problematic and urged CMS to explained the methodology used to requesting guidance for blood draws furnish co-morbidity claims data from determine the case-mix adjustment and laboratory collections, we refer the the CMS database; advocated for amount, including co-morbidities (75 commenter to Change Request 7617, inclusion of their product in the ESRD FR 49087 through 49116). In the CY Transmittal 150, entitled, PPS payment; and disputed over 2013 ESRD PPS proposed rule, we ‘‘Implementation of Changes in End payment changes to its product under stated that we were not proposing any Stage Renal Disease Payment for Part D. We appreciate the comments; changes to the methodology used to Calendar Year 2012’’ issued on however, because these comments were compute the MAP or fixed dollar loss November 16, 2011. not in response to any proposals or amounts, but were updating the outlier Comment: One commenter requested discussions in the proposed rule, they services MAP amounts and fixed dollar that CMS consider the implementation are beyond the scope of this final rule. loss amounts to reflect the utilization of of pediatric co-morbidities to the We refer the commenters to the CY 2011 outlier services reported on the 2011 pediatric case mix adjustments, while ESRD PPS final rule, where we believe claims, using the December 2011 claims another commenter requested that we addressed many of these issues file (77 FR 40964). The methodology for consideration of a case-mix adjustment (75 FR 49030). calculating and updating the base rate for race. One association called for CMS was finalized last year through notice to establish a new technology adjuster

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III. End-Stage Renal Disease (ESRD) including introducing and expanding currently none of the VBP programs Quality Incentive Program (QIP) for measures, refining the scoring measure quality across all of the six Payment Year (PY) 2015 methodology, modifying the program’s domains, we are working to ensure that public reporting requirements, each program considers measures A. Background establishing how the ESRD QIP payment supporting the six national priorities For over 30 years, monitoring the reduction applies to facilities whose where feasible. Furthermore, we are quality of care provided to end-stage ownership has changed, and initiating a working in partnership with facilities, renal disease (ESRD) patients by dialysis data validation pilot program. We beneficiaries, the National Quality providers or facilities (hereinafter received approximately 55 public Forum (NQF), the Measures Application referred to collectively as ‘‘facility’’ or comments on these proposals from Partnership, sister agencies in the ‘‘facilities’’) has been an important many interested parties including Department of Health and Human component of the Medicare ESRD dialysis facilities, organizations Services (HHS), and other stakeholders payment system. The ESRD quality representing dialysis facilities, to develop new measures where gaps incentive program (QIP) is the most nephrologists, nurses, dietitians, home exist, refine measures requiring recent step in fostering improved health advocacy groups, pharmaceutical adjustment, and remove measures when patient outcomes by establishing manufacturers, patients, advocacy appropriate. We are also working with incentives for dialysis facilities to meet groups, and the Medicare Payment stakeholders to ensure that the ESRD or exceed performance standards Advisory Commission (MedPAC). In QIP serves the needs of our beneficiaries established by CMS. The ESRD QIP is this section of the final rule, we provide and also advances the goals of the authorized by section 153(c) of MIPPA, a summary of each proposed National Quality Strategy. which added section 1881(h) to the Act. requirement, a summary of the public We believe that the development of an CMS established the ESRD QIP for PY comments received on these ESRD QIP that is successful in 2012, the initial year of the program in requirements, our responses to these promoting the delivery of high quality which ESRD payment reductions based comments, and the final policies that we healthcare services in dialysis facilities on quality performance are being made will adopt for the program. is paramount. We seek to adopt to dialysis facilities, in two rules measures for the ESRD QIP that promote published in the Federal Register on C. Considerations in Updating and high-quality, safer, and more efficient August 12, 2010 and January 5, 2011 (75 Expanding Quality Measures Under the care. In addition to the priorities of the FR 49030 and 76 FR 628, respectively). ESRD QIP for PY 2015 and Subsequent National Quality Strategy, our measure On November 10, 2011, CMS published PYs development and selection activities for a final rule in the Federal Register 1. Value-Based Purchasing (VBP) the ESRD QIP take into account other outlining the PY 2013 and PY 2014 Overview national priorities, such as those ESRD QIP (76 FR 70228). established by the National Priorities Section 1881(h) of the Act requires Throughout the past decade, Medicare Partnership (http://www.qualityforum. the Secretary to establish an ESRD QIP, has been transitioning from a program org/npp/), HHS Strategic Plan (http:// which we have implemented by (i) that pays for healthcare based solely on www.hhs.gov/secretary/about/priorities/ selecting measures; (ii) establishing the the number of services furnished to a priorities.html), the National Strategy performance standards that apply to the beneficiary to a program that ties for Quality Improvement in Healthcare individual measures; (iii) specifying a payments to providers and suppliers to (http://www.healthcare.gov/center/ performance period with respect to a the quality of care of the services they reports/quality03212011a.html), and the year; (iv) developing a methodology for deliver. By paying for the quality of HHS National Action Plan to Prevent assessing the total performance of each care, rather than merely the quantity of Healthcare Associated Infections (HAIs) facility based on the performance care, we believe we are strengthening (http://www.hhs.gov/ash/initiatives/hai/ standards with respect to the measures the healthcare system while also esrd.html). To the extent practicable, we for a performance period; and (v) advancing the National Quality Strategy have sought to adopt measures that have applying an appropriate payment and the three part aim which promote been endorsed by a national consensus reduction to facilities that do not meet (i) better care for the individual thereby organization, recommended by multi- or exceed the established Total (ii) advancing the health of the entire stakeholder organizations, and Performance Score. In this final rule, we population while also (iii) reducing developed with the input of facilities, describe each of these elements, as costs. CMS specifies the domains and purchasers/payers, beneficiaries, and applicable, and our final policies for specific measures of quality for our VBP other stakeholders. their application to PY 2015 and future programs and we are working to link the payment years of the ESRD QIP. aims of the National Quality Strategy 2. Brief Overview of Proposals with our payment policies on a national For PY 2014, we adopted measures for B. Summary of the Proposed Provisions scale. the ESRD QIP that fall under three of the and Responses to Comments on the There are currently six domains of six VBP measure priority domains based ESRD QIP for PY 2015 measurement for our VBP programs, on the National Quality Strategy: A proposed rule, entitled ‘‘Medicare based on the six priorities of the • Safety: National Healthcare Safety Program; End-Stage Renal Disease National Quality Strategy: (i) Care Network (NHSN) Dialysis Event Prospective Payment System, Payment coordination; (ii) population/ reporting; System, Quality Incentive Program, and community health; (iii) efficiency and • Patient- and caregiver-centered Bad Debt Reductions for All Medicare cost reduction; (iv) safety; (v) patient- experience: In-Center Hemodialysis Providers’’ (77 FR 40952), hereinafter and caregiver-centered experience and Consumer Assessment of Healthcare referred to as the CY 2013 ESRD PPS outcomes; and (vi) clinical care. Providers and Systems (ICH CAHPS) proposed rule, appeared in the Federal Together these domains not only survey reporting; and Register on July 11, 2012, with a encourage better care at the facility • Clinical quality of care: (i) comment period that ended on August level, but also encourage different care Hemoglobin Greater Than 12 g/dL; (ii) 31, 2012. In that proposed rule, we settings to interface to comprehensively Hemodialysis Adequacy (Urea made proposals for the ESRD QIP, improve healthcare overall. Although Reduction Ratio (URR)); (iii) Vascular

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Access Type; (iv) and Mineral the following measures that are under and efficiency measures for the ESRD Metabolism reporting (76 FR 70228). consideration for possible adoption in QIP. For PY 2014, we also proposed to subsequent payment years: a 30-Day Four proposed measures for the PY change the requirements for the Mineral Hospital Readmission measure to 2015 ESRD QIP (that is, three for Metabolism reporting measure. address care coordination; an access to dialysis adequacy and one for For PY 2015, we proposed to add new care measure to address population/ hypercalcemia) were made publicly measures in the clinical quality of care community health; and an efficiency available in accordance with section domain and to expand the scope of the measure. We also discussed the 1890A(a)(2) of the Act and were NHSN Dialysis Event reporting measure Standardized Hospitalization Ratio reviewed by the Measures Application (safety domain) and the Mineral Admissions (SHR) measure and the Partnership. The Measures Application Metabolism reporting measure (clinical Standardized Mortality Ratio (SMR) Partnership gave support to two of the quality of care domain). We believe that measure that we are considering for proposed measures, NQF #1454: the PY 2015 ESRD QIP should not only program adoption in future years. We Proportion of patients with promote the health of ESRD patients, welcomed, and continue to welcome, hypercalcemia and NQF #1423: but also uphold the goals of the National further comments on these and other Minimum spKt/V for Pediatric Quality Strategy (NQS). To that end, we potential measures for future payment Hemodialysis Patients. The Measures proposed to include 11 measures in the years. Application Partnership supported the PY 2015 ESRD QIP. We also proposed direction of a proposed composite 3. Measures Application Partnership measure comprised of two NQF- to include these measures and measure Review topics in subsequent payment years. endorsed measures, NQF #0249: The proposed measures would evaluate In addition to the considerations Hemodialysis Adequacy Clinical facilities on the following topics that fall discussed above, in selecting measures Performance Measure III: Hemodialysis under the NQS clinical quality of care for the PY 2015 ESRD QIP, we Adequacy—HD Adequacy—Minimum measure domain: considered input from the multi- Delivered Hemodialysis Dose and NQF stakeholder group, the Measures #0318: Peritoneal Dialysis Adequacy • For purposes of evaluating anemia Application Partnership (http://www. Clinical Performance Measure III— management: qualityforum.org.map/). Section Delivered Dose of Peritoneal Dialysis Æ Hemoglobin Greater Than 12 g/dL, 1890A(a)(1) of the Act, as added by Above Minimum. The Measures a clinical measure. section 3014(b) of the Affordable Care Application Partnership recommended Æ Anemia Management, a reporting Act, requires the entity with a contract that the composite measure comprised measure.* • under section 1890(a) of the Act, of the two NQF dialysis adequacy To evaluate dialysis adequacy: currently NQF, to convene multi- Æ A clinical Kt/V measure for adult measures be tested to ensure feasibility. stakeholder groups to provide input to We took these comments into hemodialysis patients.* the Secretary on the selection of quality Æ A clinical Kt/V measure for adult consideration when we proposed and efficiency measures for use in measures for the PY 2015 ESRD QIP. peritoneal dialysis patients.* Æ certain programs. Section 1890A(a)(2) of A clinical Kt/V measure for the Act requires the Secretary, not later 4. PY 2014 Mineral Metabolism Measure pediatric hemodialysis patients.* • than December 1 of each year, to make In the CY 2012 ESRD PPS final rule, To determine whether patients are available to the public a list of quality we adopted the Mineral Metabolism treated using the most beneficial and efficiency measures that are under reporting measure for the PY 2014 ESRD type of vascular access: consideration for use in certain QIP which requires each facility to attest Æ An arteriovenous fistula measure. Æ programs. Section 1890A(a)(3) of the that it monitored serum calcium and A catheter measure. Act requires the entity with a contract serum phosphorus at least once a month • To address effective bone mineral under section 1890(a) of the Act to for each Medicare ESRD patient (76 FR metabolism management: transmit the input of the multi- 70271). We have since realized, Æ Hypercalcemia, a clinical stakeholder groups to the Secretary not however, that it may be difficult for measure.* later than February 1 of each year, some facilities to make this attestation Æ Mineral Metabolism, a reporting beginning in 2012. Section 1890A(a)(4) if, for example, a patient is seen at the measure (expansion proposed). of the Act requires the Secretary to take beginning of the month, his or her blood Additionally, we proposed to expand into consideration the input of the is not drawn, and then he or she is a previously adopted reporting measure multi-stakeholder groups in selecting hospitalized or transient for the addressing safety: • quality and efficiency measures. The remainder of the month. While it is our NHSN Dialysis Event reporting Measures Application Partnership is the intention to encourage facilities to put measure. public-private partnership comprised of systems and processes into place to We also proposed to continue using a multi-stakeholder groups convened by ensure at least monthly serum calcium previously adopted reporting measure NQF for the primary purpose of and phosphorus monitoring, we believe assessing patient- and caregiver- providing input on measures as required it is reasonable to give consideration to centered experience: by sections 1890A(a)(1) and (3) of the situations where the monthly blood • ICH CAHPS survey reporting Act. The Measures Application draw does not happen within the measure. Partnership’s input on the quality and dialysis facility given these scenarios. *Indicates that the measure is new to efficiency measures under consideration Therefore, for PY 2014, we proposed to the ESRD QIP. for adoption in CY 2012 was transmitted change the Mineral Metabolism Although we did not propose to adopt to the Secretary on February 1, 2012 and reporting requirement. measures that address care is available at (http://www.qualityforum. We considered proposing to require coordination, population/community org/WorkArea/linkit.aspx?Link facilities to report the required health, or efficiency and cost of care, we Identifier=id&ItemID=69885). As information for less than 100 percent of solicited comments in the proposed rule required by section 1890A(a)(4) of the their patients. There are circumstances, on potential measures that would fall Act, we considered these however, that are beyond a facility’s into each of these areas. We discussed recommendations in selecting quality control wherein it may not be able to

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draw a sample for this patient. commenters suggested that we modify treated by the facility fewer than seven Therefore, for purposes of scoring the the exclusion to include the following times during the reporting month. measure, we proposed to modify the PY patients: (i) Beneficiaries who are We do not believe that it is necessary 2014 measure to require that, in order regularly treated at the facility and who to specifically exclude transient patients for a facility to receive 10 points on the fit into one of these categories: (a) from this measure because, as noted, PY 2014 Mineral Metabolism measure, Beneficiaries who die within the any patient that is treated by the facility it must attest that it monitored on a applicable month; (b) beneficiaries that at least seven times during the monthly basis the serum calcium and receive fewer than 7 treatments in a applicable reporting month is present at serum phosphorus levels for every month; and (c) beneficiaries receiving the facility for enough time that the Medicare ESRD patient provided that: home dialysis therapy who miss their facility should be held accountable for (i) The patient is alive for the entirety in-center appointments when there is a that patient. Likewise, for the same of the applicable month; (ii) if the documented, good faith effort to have reasons mentioned above, we do not patient is treated in-center, that patient them participate in such a visit during believe we need to separately exclude patients who are deceased at the end of was treated at that facility at least twice the applicable month; (ii) transient the reporting month. Provided that the during the claim month; and (iii) if the dialysis patients; (iii) pediatric patients patient is treated by the facility at least patient receives dialysis at home, a (unless the measure is specific to this facility must report this information seven times during that month, the population); and (iv) kidney transplant regardless of the number of treatments, facility should be able to draw blood recipients with a functioning graft. provided that a claim is submitted for necessary to monitor serum calcium and Commenters stated that these exclusions that patient. We also proposed that if a serum phosphorus levels even if the patient is hospitalized or transient are consistent with our own measures, patient is deceased at the end of the during a claim month, the facility could CROWNWeb, and the URR reporting month. monitor the serum calcium and serum specifications; additionally, these We continue to believe that facilities phosphorus readings for that patient for exclusions seek to hold facilities should be required to attest that they the month if a patient has labs drawn by accountable only for those beneficiaries monitored the serum calcium and another provider/facility, those labs are to whom they regularly give care and for phosphorus levels of home dialysis evaluated by an accredited laboratory (a whose care they can affect. One patients irrespective of whether those laboratory that is accredited by, for commenter believed that home dialysis patients attend a monthly appointment. example, Joint Commission, College of patients should only be included if they We believe that it is incumbent upon a American Pathologists, AAB (American attend their monthly visit. One facility to make home dialysis patients Association of Bioanalysts), or State or commenter requested that we use NQF aware that they must attend monthly Federal agency), and the dialysis facility inclusion criteria for purposes of appointments to be properly treated. In reviews the serum calcium and serum defining the exclusions of the Mineral addition, since the mechanisms that phosphorus readings. We stated our Metabolism reporting measure. cause cardiovascular and bone disease belief that these proposals will provide Response: Upon further review, we do not differ between home and in- more flexibility for facilities and will agree with commenters who believe that center hemodialysis patients, we believe also prevent facilities from drawing the exclusions should be modified. We that the inclusion of home dialysis blood, even when not necessary, each recognize that treating a patient twice patients in the Mineral Metabolism time a patient visits for fear that he or may not provide enough time to reporting measure is appropriate. Therefore we will finalize our proposal she will fail to come to the facility again effectuate quality patient care. We agree that we will include any home during that month. We requested with the commenters who suggested hemodialysis patient for which a facility comment on this proposal. that an in-center hemodialysis patient submits a claim with respect to the We also requested comment on our should be excluded if treated by a reporting month in this measure. consideration to lower the attestation to facility fewer than seven times during monthly monitoring of 98 percent of We also believe it is important to the month, regardless of whether the Medicare ESRD patients. We chose 98 include transplant patients until they patient is officially admitted to that percent in order to encourage are officially discharged from a facility; facility. With seven treatments, we improvement, and to ensure that we do regular monitoring can help ensure that believe that a facility should have had not undermine the current level of high- a transplant remains effective and that reporting (based on the CROWNWeb adequate opportunities to draw blood the facility is continuing to provide the pilot data). We recognize that 100 necessary to measure serum calcium best care possible. percent might not be appropriate due to and phosphorus levels. We also believe We believe it is important to monitor some individual cases that may not fit that the threshold of seven will serum calcium and serum phosphorus specified criteria. discourage unnecessary testing of in- levels in adult and pediatric patients Additionally, for purposes of center hemodialysis patients by alike because improper bone mineral clarification, we noted that the PY 2014 facilities because they will know that, metabolism management can lead to attestations for both the Mineral since in-center patients are typically serious, negative outcomes, including Metabolism and ICH CAHPS measures treated three times per week, a patient death, in both populations. Although we will become available in CROWNWeb in must have been treated by the facility are aware that specific target values for December 2012. As noted in the CY for at least two weeks to be included; calcium and phosphorus have not been 2012 ESRD PPS final rule, these thus, the facility need not feel pressure set for the pediatric population, we still attestations must be made before to draw blood for every in-center patient believe that this measure will lead to January 31, 2013 (76 FR 70269, 70271). during the first few visits of the month. better observation of mineral We received the following comments Based on these considerations, we will metabolism in these patients if one or on these proposals: not finalize our proposal to exclude both of these values are unusually high Comment: Many commenters were only in-center patients who have been or low. Additionally, we believe that the appreciative of our willingness to revisit treated fewer than two times by the inclusion of pediatric patients in this our requirements for the PY 2014 facility during the claim month. Instead, measure is consistent with current Mineral Metabolism attestation. Some we will exclude any patient who is guidelines on the frequency of mineral

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metabolism testing as reported in levels for approximately 96 percent of stated that facilities may obtain lab KDIGO guidelines chapter 3 ‘‘Diagnosis their patients. Therefore, we will values from other providers. This of CKD–MBD: biochemical finalize that facilities must attest to proposal was specifically designed to abnormalities.’’ Thus, we believe that monitoring calcium and phosphorus on afford facilities more flexibility in this measure is appropriate for both a monthly basis for at least 96 percent, acquiring serum calcium and adult and pediatric patients. in total, of (i) in-center Medicare phosphorus values. Facilities are highly Finally, we do not believe that we patients who have been treated at least encouraged to coordinate with other must use NQF inclusion criteria for this seven times by the facility; and (ii) providers, but this measure does not measure. Although we seek to align our home hemodialysis Medicare patients mandate them to do so. We believe that measures and our selection criteria with for whom the facility submits a claim.1 the commenters’ concerns about NQF as much as possible, as we stated We are concerned that small facilities inconsistent lab data are mitigated by in the CY 2011 ESRD PPS Final Rule, may be disproportionately impacted by the requirement that the lab must be we believe it is appropriate, at this time this 96 percent reporting threshold accredited. Facilities can use these to employ a measure that has not been because, for example, a facility with 10 values for the purpose of monitoring the NQF-endorsed (76 FR 70271 through patients could miss monitoring for only serum calcium and phosphorus levels of 72). one patient and fail to meet the their patients; additionally, collecting For the reasons stated above, we are threshold. We have previously stated these data may encourage providers to finalizing that to earn 10 points on the that, to disincentivize cherry picking, engage one another about the patient’s Mineral Metabolism reporting measure, we seek to ensure that one patient does conditions and care. facilities must attest in CROWNWeb not skew a facility’s score. We do, Comment: Several commenters asked that they have monitored the serum however, seek to ensure the highest for clarification on the following points: calcium and serum phosphorus levels quality of care regardless of the facility (1) Are only Medicare patients included on a monthly basis for (i) in-center size. Taking these two competing in the denominator, (2) are Medicare Medicare patients who have been interests into consideration, we believe Railroad and Medicare Advantage (MA) treated at least seven times by the that it is appropriate to allow facilities patients included in the denominator, facility; and (ii) home hemodialysis that treat less than 11 Medicare patients (3) could CMS give an example of an Medicare patients for whom the facility during the performance period to attest accurate application of the exclusions submits a claim. that they have met the requirements for and/or threshold, (4) if CMS institutes a Comment: Several commenters this measure if they monitored the threshold, would it be rounded, (5) if a encouraged us to not adopt a percentage serum calcium and serum phosphorus patient is excluded from the measure for reporting threshold because it does not levels on a monthly basis for at least all attestation purposes, must his or her distinguish between beneficiaries but one of its (i) in-center Medicare values still be reported in CROWNWeb, legitimately excluded and those that patients who have been treated at least and (6) how does CMS plan on counting were merely missed. Other commenters seven times by the facility; and (ii) the number of treatments for home requested that we use both exclusions home hemodialysis Medicare patients patients. and a threshold, recognizing that there for whom the facility submits a claim. Response: We will address these are some circumstances preventing We believe 11 is the appropriate cut-off questions in turn. blood draws that facilities cannot because, as we explain below, a case First, a facility treating at least 11 control; one commenter suggested a minimum of 11 allows us to include as Medicare patients during the threshold of 90 percent or an allowance many facilities as possible while also performance period is required to of two patients to ensure that small taking into account privacy and monitor serum calcium and serum facilities are not disproportionally reliability. We believe that one is the phosphorus on a monthly basis for all affected. Another commenter appropriate number because, as noted (i) in-center Medicare patients who have recommended that we use a threshold of above, although we seek to ensure the been treated at least seven times by the 95 percent. Another commenter stated highest quality of care regardless of facility; and (ii) home hemodialysis that requiring 98 percent reporting may facility size, we also seek to mitigate Medicare patients for whom the facility make it difficult for patients to travel cherry-picking by ensuring that one submits a claim. These patients include because dialysis facilities may patient does not skew a facility’s score. Medicare Advantage and Medicare encourage them otherwise to ensure Comment: Many commenters noted Railroad beneficiaries. compliance with the measure. that it is impractical for facilities to As an example of the application of Response: We agree with the obtain labs from other providers because the exclusions and threshold, assume commenters who argued that, even with other providers are not required to the following: (i) A facility treats 30 exclusions, there are circumstances in measure these data, do not share data Medicare patients in month X; (ii) which facilities cannot attest to with dialysis facilities, and, even if patient A is an in-center hemodialysis monitoring the serum calcium and facilities could obtain these data, they patient who was treated by the facility serum phosphorus levels for every could not be sure that the labs were seven times during the first two weeks patient at least once per month. For consistent or reported under the same of month X, but the facility failed to example, a facility may wait until later standards. obtain a blood draw during this period, to draw blood from a patient because it Response: We recognize that it may be and the patient is in the hospital for the believes that patient will be treated by difficult for facilities to coordinate with next two weeks of month X but the the facility for the entirety of the month, hospitals and other care providers in facility monitors the patient’s serum but learns that the patient has been order to obtain lab values. Accordingly, phosphorus and calcium by obtaining hospitalized unexpectedly for all or part we are not mandating facilities to do so. these values from the hospital; (iii) of the applicable month. Therefore, we In the proposed rule (77 FR 40969), we patient B and C are both in-center believe that we should not require an hemodialysis patients who were treated attestation of 100 percent monitoring. 1 We note that the reporting requirements are by the facility at least seven times Based on data from the CROWNWeb somewhat different for CROWNWeb. All patients during month X, but the facility fails to must be reported for CROWNWeb purposes, even pilot, we believe that facilities report if those patients would not be included in the monitor the serum calcium and serum serum calcium and serum phosphorus measure for purposes of the ESRD QIP. phosphorus of these patients during

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month X; (iv) patient D was visiting the 2014 program. Therefore, we consider particular topic becomes available; (6) a facility and was treated by the facility these comments to be outside the scope measure that is more strongly associated only 4 times during month X; and (v) of the proposed rule. We refer readers to with desired patient outcomes for the the facility monitors the serum calcium the 2012 ESRD PPS final rule for more particular topic becomes available; or and serum phosphorus on a monthly information on the finalized PY 2014 (7) collection or public reporting of a basis for every other (i) in-center ESRD QIP (76 FR 70228). measure leads to negative unintended Medicare patient who had been treated For the reasons stated above, we consequences. If there is reason to at least seven times by the facility finalize that a facility treating at least 11 believe that a measure raises potential during month X; and (ii) home Medicare patients during the safety concerns, we proposed that we hemodialysis Medicare patient for performance period can attest to would take immediate action to remove whom the facility submitted a claim meeting the requirements of the PY the measure from the ESRD QIP and not during month X. The facility is 2014 Mineral Metabolism reporting wait for the annual rulemaking cycle. considered to have monitored the serum measure if it monitors on a monthly We proposed that such measures would calcium and serum phosphorus during basis the serum calcium and serum be promptly removed from the measure month X for every patient except B and phosphorus for at least 96 percent in set, and we would confirm the removal C because patient D was only treated total of all (i) in-center Medicare in the next ESRD QIP rulemaking cycle. four times during the month and the patients who have been treated at least ESRD facilities and the public would be facility obtained the values for patient A seven times by the facility; and (ii) immediately notified of our decision to from another provider. The facility’s home hemodialysis Medicare patients remove a measure that raises potential monitoring rate for month X is 27/29, or for whom the facility submits a claim. safety concerns through the usual ESRD 93.1 percent (rounded to 93 percent). A We also finalize that a facility treating program communication channels, facility with 30 patients must attest that fewer than 11 Medicare patients during including memos, email notification, it monitored on a monthly basis the the performance period can attest to and web postings. serum calcium and serum phosphorus meeting the requirements of the PY Many of the quality measures used in for all (i) in-center Medicare patients 2014 Mineral Metabolism reporting different Medicare and Medicaid who have been treated at least seven measure if it monitors on a monthly reporting programs are endorsed by times by the facility; and (ii) home basis the serum calcium and serum NQF. As part of its regular maintenance hemodialysis Medicare patients for phosphorus levels for at least all but one process for endorsed performance whom the facility submits a claim. of its (i) in-center Medicare patients measures, the NQF requires measure Therefore, this facility could not attest who have been treated at least seven stewards to submit annual measure that it successfully monitored the serum times by the facility; and (ii) home maintenance updates and undergo calcium and serum phosphorus in total hemodialysis Medicare patients for maintenance of endorsement review for at least 96 percent of its (i) in-center whom the facility submits a claim. every 3 years. Under the measure maintenance process, the measure Medicare patients who had been treated D. Proposed Measures for the PY 2015 steward (owner/developer) is at least 7 times by the facility; and (ii) ESRD QIP and Subsequent PYs of the responsible for updating and home hemodialysis Medicare patients ESRD QIP maintaining the currency and relevance for whom the facility submitted a Similar to our other quality reporting claim.2 For purposes of this measure, of the measure and confirming and pay for performance programs, we specification changes to NQF on an facilities may round up to a whole proposed that once a quality measure is annual basis. NQF solicits information percentage point when calculating selected and finalized for the ESRD QIP from measure stewards for annual whether they met the 96 percent through rulemaking, the measure would reviews in order to review measures for threshold. continue to remain part of the program Finally, for the reasons discussed continued endorsement in a specific 3- for all future years, unless we remove or year cycle. Non-NQF-endorsed above, facilities will be required to replace it through rulemaking or measures may also go through similar monitor the serum calcium and serum notification (if the measure raises maintenance by their measure stewards; phosphorus at least once per month for potential safety concerns). We believe such maintenance includes reviewing every home hemodialysis patient for that this will streamline the rulemaking and updating measures. whom it submits a claim regardless of process, provide continuity of quality Through the measure maintenance the number of treatments during that measurement, and allow ESRD facilities process, measures are sometimes month. to plan both quality reporting and updated to incorporate changes that we Comment: Many commenters quality improvement activities. In believe do not substantially change the requested that we revisit various aspects general, we anticipate considering nature of the measures. Examples could of the PY 2014 ESRD QIP. quality measures for removal or be changes to exclusions to the patient Response: The PY 2014 ESRD QIP replacement if: (1) Measure performance population, changes to definitions, or was finalized on November 1, 2011 (76 among the majority of ESRD facilities is extension of the measure endorsement FR 70228). Although we requested so high and unvarying that meaningful to apply to other settings. We believe comment regarding the PY 2014 Mineral distinctions in improvements or these types of maintenance changes are Metabolism reporting measure in the performance can no longer be made; (2) distinct from more substantive changes proposed rule, we did not propose to performance or improvement on a to measures that result in what are reconsider any other elements of the PY measure does not result in better or the considered new or different measures, intended patient outcomes; (3) a and that they do not trigger the same 2 Note that, for ease, we provided an example for only one month. However, to make the attestation, measure no longer aligns with current agency obligations under the a facility must monitor for the duration of the clinical guidelines or practice; (4) a Administrative Procedure Act. performance period the serum calcium and serum more broadly applicable (across settings, We proposed that if a measure that we phosphorus levels on a monthly basis for all (i) in- populations, or conditions) measure for have adopted for the ESRD QIP is center Medicare patients who have been treated at least seven times by the facility; and (ii) home the topic becomes available; (5) a updated in a manner that we consider hemodialysis Medicare patients for whom the measure that is more proximal in time to not substantially change the nature of facility submits a claim. to desired patient outcomes for the the measure, we would use a

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subregulatory process to incorporate commenters who argue in favor of the proposed criteria to mean that we those updates to the measure implementing measures that meet the should implement only measures that specifications that apply to the program. proposed criteria. We do not believe do not meet the proposed removal Specifically, we would revise our that an emergency technical expert criteria. We recognize the potential previously adopted measure panel (TEP) is an appropriate part of the value in taking these criteria into specifications to clearly identify the removal process, as we typically consideration for measure updates made by the NQF or other convene TEPs in order to obtain expert implementation, and believe we do so to measure steward and either post the stakeholder input as part of the measure the extent practicable. However, we updates directly on the CMS Web site or development process. These TEPs are believe that we must take into provide links to where the updates can convened as needed during the measure consideration additional criteria, such be found. We would also provide maintenance cycle and can provide any as statutory requirements governing the sufficient lead time for facilities to necessary comment regarding the ESRD QIP and emergent public health implement the changes where changes clinical appropriateness of implemented and safety issues, when determining to the data collection systems would be measures. Emergency TEPs would also what measures to propose and finalize necessary. be difficult and expensive to employ for the program. In some cases, it is We proposed to continue to use the quickly, such as in response to public possible that these issues will take rulemaking process to adopt changes to comments in support of measure precedence over the criteria proposed a measure that we consider to removal. We will consider the inclusion for measure removal. substantially change the nature of the of additional removal criteria such as Comment: Several commenters urged measure. We stated our belief that this those suggested by commenters through us to adopt measure specifications and proposal adequately balances our need future rulemaking, but will finalize the data definitions that are clear, to incorporate updates to ESRD QIP proposed criteria to remain consistent modifying this information through measures in the most expeditious with similar criteria implemented for rulemaking alone. Commenters argued manner possible, while preserving the other quality reporting and pay-for- that it is only appropriate to use sub- public’s ability to comment on updates performance programs, such as the regulatory processes to aid facilities in that so fundamentally change an Hospital Inpatient Quality Reporting interpreting the specifications and endorsed measure that it is no longer Program and Hospital Outpatient definitions, and suggested that we the same measure that we originally Quality Reporting Program. The second develop a regular and transparent adopted. We invited public comment on criterion we proposed, the availability process for collecting and responding to this proposal and on our proposal that of alternative measures with a stronger these questions, ideally on a quarterly once a quality measure is adopted, it is relationship to patient outcomes, is basis with a schedule set forth in rules. retained for use in the subsequent ESRD intended to allow us to implement new Response: We thank those QIP payment years unless we remove or measures in the ESRD QIP that have a commenters who provided feedback to replace it as discussed above. stronger association with relevant health our proposal to update NQF-endorsed The comments we received on these outcomes. Such measures may better measures using a subregulatory process. proposals and our responses are set assess the quality of care provided by We concur that measure specifications forth below. dialysis facilities and in such cases, we and data definitions should be clear. Comment: Commenters requested believe it would be appropriate to However, we believe that using a clarification regarding the removal or reflect this in the ESRD QIP. Our use of subregulatory process to make certain replacement criteria for measures, the fifth criterion is consistent with this types of updates to measures is specifically the criteria listed in (2) and principal, and would be applied in appropriate. The NQF regularly (5) and the process for removal or those circumstances where we believe maintains its endorsed measures replacement. Commenters suggested existing measures are not as temporally through annual and triennial reviews, that CMS provide illustrative scenarios proximal to health outcomes of interest which may result in the NQF making and consider convening an emergency as are newly available measures. We updates to the measures. We believe technical expert panel (TEP) to identify believe that in such cases, it would be that it is important to have in place a and analyze removal or replacement appropriate to remove these measures, subregulatory process to incorporate issues. Commenters also encouraged us rather than simply increase the volume non-substantive updates made by the to add two criteria for removal or of quality measures for which dialysis NQF to the measure specifications we replacement: (i) Negative unintended facilities are responsible under the have adopted for the ESRD QIP so that consequences to the Medicare ESRD ESRD QIP. these measures remain up-to-date and system as a whole; and (ii) if data for a Except for measures that raise clinically relevant. We also recognize measure cannot be collected reliably potential safety concerns, any decisions that some changes the NQF might make and accurately or if collecting the data to remove or replace measures under the to its endorsed measures are substantive places an undue burden on facilities. ESRD QIP will be made through the in nature and might not be appropriate One commenter asked that CMS confirm rulemaking process. Each year, we will for adoption using a subregulatory that we will use rulemaking to retire or assess whether any measures should be process. Therefore, we are finalizing a remove measures from the ESRD QIP. removed or replaced under the ESRD policy under which we will use a Finally, the commenters stated that QIP, and we will make appropriate subregulatory process to make non- some of the measures proposed meet the proposals during the rulemaking cycle. substantive updates to NQF-endorsed replacement and removal criteria and Stakeholders will then have the measures used for the ESRD QIP. With suggested that CMS implement only opportunity to provide feedback respect to what constitutes substantive new measures that meet the proposed regarding the proposed removal or versus non-substantive changes, we criteria. replacement of these measures, and the expect to make this determination on a Response: We thank those rationale behind our proposals. Any case-by-case basis. Examples of non- commenters who provided suggestions measure removal will then be finalized substantive changes might include regarding the criteria and process for as part of the ESRD PPS final rule. updated diagnosis or procedure codes, measure replacement or removal from We take the suggestion that we medication updates for categories of the ESRD QIP. We concur with those implement only new measures that meet medications, broadening of age ranges,

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and exclusions for a measure (such as setting, such as extending a measure process to make non-substantive the addition of a hospice exclusion to from the inpatient setting to hospice. updates to measures, and will use the the 30-day mortality measures used in These policies regarding what is rulemaking process to make substantive the Hospital IQR Program). We believe considered substantive versus non- updates to measures. that non-substantive changes may substantive would apply to all ESRD 1. PY 2014 Measures Continuing for PY include updates to NQF-endorsed QIP measures. We also note that the 2015 and Subsequent PYs measures based upon changes to NQF process incorporates an guidelines upon which the measures are opportunity for public comment and We previously finalized six measures based. engagement in the measure maintenance including one measure with two We will continue to use rulemaking to process. measure sub-components (see Table 2 adopt substantive updates made by the We aim to be as transparent as below) for the PY 2014 ESRD QIP (76 FR NQF to the endorsed measures we have possible in implementing the ESRD QIP. 70228). We proposed to continue to use adopted for the ESRD QIP. Examples of Occasionally, questions arise related to five of these measures for the PY 2015 changes that we might consider to be measures that have been adopted. We ESRD QIP; however, we also proposed substantive would be those in which the plan to publish these questions and to augment two (NHSN Dialysis Event changes are so significant that the answers on a publicly available Web reporting and Mineral Metabolism measure is no longer the same measure, site. We will consider standardizing a reporting) of these five measures used in or when a standard of performance timeline for submission of and answers PY 2014 to continue to promote assessed by a measure becomes more to these questions as the program improvement in the PY 2015 ESRD QIP. stringent (for example, changes in the evolves. We proposed to remove the PY 2014 acceptable timing of medication, For the reasons discussed above, we URR Dialysis Adequacy measure. In procedure/process, or test are finalizing our proposal regarding addition, we proposed to add three new administration). Another example of a continued use of measures in the ESRD measures of dialysis adequacy, an substantive change would be where the QIP unless we remove or replace them. anemia management reporting measure, NQF has extended its endorsement of a We are also adopting a policy under and a hypercalcemia clinical measure previously endorsed measure to a new which we will use a subregulatory (Table 3).

TABLE 2—MEASURES ADOPTED FOR THE PY 2014 ESRD QIP

NQF No. Measure title

N/A ...... Percent of Patients with Hemoglobin Greater Than 12 g/dL*

N/A ...... URR Hemodialysis Adequacy

N/A for composite measure Vascular Access Type ...... Hemodialysis Vascular Access-Maximizing Placement of Arterial Venous Fistula (AVF)* (NQF#0257). Hemodialysis Vascular Access-Minimizing use of Catheters as Chronic Dialysis Access* (NQF#0256).

N/A1 ...... NHSN Dialysis Event Reporting*+ Enroll and report 3 months of dialysis event data.

N/A2 ...... In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Sys- tems (ICH CAHPS) Survey Reporting* Facilities are required to attest that they administered the ICH CAHPS survey via a third party during the performance period.

N/A3 ...... Mineral Metabolism Reporting Facilities are required to attest that they have monitored each of their Medicare pa- tient’s phosphorus and calcium levels monthly throughout the performance pe- riod.*+ 1 We note that an NQF-endorsed bloodstream infection measure (NQF#1460) exists, and data for this measure is collected as part of dialysis event reporting in NHSN. It is our intention to use this measure in future years of the ESRD QIP. We believe that a reporting measure is a nec- essary step in reaching our goal to use NQF#1460. 2 We note that a related measure utilizing the results of this survey has been NQF-endorsed (#0258), and it is our intention to use this meas- ure in future years of the ESRD QIP. We believe that a reporting measure is a necessary step in reaching our goal to use NQF#0258. 3 We note that the NQF has previously endorsed phosphorus and calcium monitoring measures (#0261 and #0255) upon which this measure is based. NQF has since withdrawn its endorsement of the calcium measure. * Indicates a measure we are proposing for PY 2015 and future years of the ESRD QIP. + Indicates a measure we are proposing to augment for PY 2015 and future years of the ESRD QIP.

TABLE 3—NEW MEASURES PROPOSED FOR THE ESRD QIP PY 2015 AND FUTURE YEARS OF THE PROGRAM

NQF No. Measure title

N/A ...... Anemia Management Reporting. 0249 ...... Hemodialysis Adequacy Clinical Performance Measure III: Hemodialysis Adequacy—HD Adequacy—Minimum Delivered Hemo- dialysis Dose. 0318 ...... Peritoneal Dialysis Adequacy Clinical Performance Measure III—Delivered Dose of Peritoneal Dialysis Above Minimum. 1423 ...... Minimum spKt/V for Pediatric Hemodialysis Patients. 1454 ...... Proportion of Patients with Hypercalcemia.

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We proposed to continue using two incentivize clinics to provide proper once the facility became aware that their measures and one measure topic ESA dosage with the ESRD PPS hemoglobin levels were over 12 g/dL. adopted in PY 2014 for the PY 2015 payment bundle and the Hemoglobin Finally, one commenter noted that ESRD QIP and subsequent payment Greater than 12 g/dL measure combined. hemoglobin levels at high altitude years of the program. For the reasons Finally, one commenter urged us to facilities are more likely to be greater stated in the CY 2012 ESRD PPS final individualize anemia management than 12 g/dL. rule (76 FR 70262, 70264 through 65, measures. Response: We thank the commenters 70269), we proposed to continue using: Response: We appreciate feedback who made suggestions regarding the (i) The Hemoglobin Greater than 12 g/ relating to the use of the Hemoglobin refinement of the Hemoglobin Greater dL measure; (ii) the Vascular Access Greater Than 12 g/dL measure in the Than 12 g/dL measure. Addressing the Type measure topic comprised of two ESRD QIP. We recognize that changes in concern commenters raised with the measures, (a) the Hemodialysis Vascular the incentive structure for ESA therapy high degree of variability in hemoglobin Access-Maximizing Placement of AVF may have consequences for ESA from month to month, the measure rate (NQF #0257) measure, and (b) the utilization. We feel, however, that is calculated using the average Hemodialysis Vascular Access- because of the negative clinical hemoglobin of a patient over 4–12 Minimizing use of Catheters as Chronic outcomes that can result from high months. For example, if a patient is Dialysis Access (NQF #0256) measure; hemoglobin levels in the ESRD treated for 4 months, then we use the and (iii) the ICH CAHPS survey population, this measure is still average of the 4-month period to reporting measure. The technical important in ensuring that facilities calculate the measure rate. If a patient specifications for these measures can be provide quality care. is treated for 5 months, we use the found at http://www.dialysisreports.org/ We also appreciate the need to average from that 5-month period and so pdf/esrd/public-measures/Anemia consider dosage and clinical practice on. Relevant to concerns raised about Management-HGB-2015-NPRM.pdf; when ascertaining the potential adverse the exclusion of patients who have just http://www.dialysisreports.org/pdf/esrd/ effects of ESA therapy. We have begun begun ESA therapy, the measure public-measures/VascularAccess- to develop additional anemia currently excludes new patients (less Catheter-2015-NPRM.pdf; http://www. management measures that account for than 90 days since ESRD onset), and dialysisreports.org/pdf/esrd/public- ESA dose. These measures are focused excludes claims for which there is no measures/VascularAccess-Fistula-2015- on utilization of ESAs and transfusion evidence of ESA use. We believe these NPRM.pdf; and http://www.dialysis avoidance to further incentivize proper exclusions address the commenters’ reports.org/pdf/esrd/public-measures/ care. We intend to propose to adopt one concerns. Regarding the comment that ICHCAHPS-2015-NPRM.pdf. We or more of these measures for the ESRD hemoglobin levels at high altitude requested comment on the proposed QIP in future rulemaking. facilities are more likely to reach the continuation of these measures. Finally, we agree that it is important measure threshold, we do not currently The comments we received on these to individualize care for each employ risk adjustment for the measure proposals and our responses are set beneficiary. We believe that the for this or other environmental factors forth below. We will separately discuss Hemoglobin Greater than 12 g/dL that could conceivably have similar each of the measures and the comments measure both allows facilities discretion impacts. However, we plan to conduct received on these measures. to properly manage hemoglobin levels monitoring and surveillance of our in each patient and prevents adverse quality measures for issues such as a. Hemoglobin Greater Than 12 g/dL patient outcomes associated with geographical variation. Comment: Many commenters strongly hemoglobin levels that are too high. Comment: One commenter argued supported the continuation of this However, we recognize that greater that using patients’ yearly averages for measure, specifically because proper individualization may be possible and measures fails to test the actionability of anemia management can prevent are currently working to develop the measures because it is difficult to patients from developing serious, life additional anemia management identify areas of improvement until the threatening conditions. Other measures that will enhance this aspect end of the year. Instead, the commenter commenters, however, asked that we of the ESRD QIP. suggests ‘‘per-facility averaging,’’— consider removing the measure or Comment: Several commenters averaging of end-of-month hemoglobin reducing its weight since high supported the measure, generally, but results for each facility’s patients, each hemoglobin and ESA overuse no longer asked us to make refinements. One month, then averaging up to 12 of those pose a realistic concern because of the commenter suggested that we measure facility monthly averages, which this economic incentives of the ESRD PPS hemoglobin on a three or 6-month commenter argued allows facilities to payment bundle and the new clinical rolling basis rather than monthly know their year-to-date numerators and evidence and FDA-approved label for because monthly measurement does not denominators, fostering ongoing quality ESAs (http://www.fda.gov/Drugs/ provide a comprehensive assessment of incentive and process improvement. DrugSafety/ucm259639.htm). One the care patients are receiving; studies Response: We appreciate the commenter noted that the TREAT study show that although hemoglobin levels commenter’s suggestion regarding per- and its own research indicate that large can fluctuate greatly within short facility averaging and all feedback to ESA doses, rather than high hemoglobin periods of time, the mean hemoglobin improve the usefulness of our quality levels, result in adverse effects. Finally, level can remain in the measure target measures to facilities. However, we one commenter believes that the range. Another commenter stated that, believe that averaging hemoglobin over Hemoglobin Greater Than 12 g/dL as the measure is currently conceived, multiple patients in a facility would be measure leads to confusion because facilities cannot act on its results. inconsistent with medical guidance, physicians begin increasing ESA dosage Because it takes time for hemoglobin which deals with patient specific only after hemoglobin levels have fallen levels to change, one commenter situations. We believe that facilities far below 12 g/dL, resulting in an recommended excluding patients who should strive to provide the best care to increase in patients with low have been on ESA therapy for one each patient treated by the facility. hemoglobin levels. The same month or less and patients whose ESA Comment: One commenter requested commenter noted that it is difficult to therapy was promptly discontinued confirmation that patients who are not

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on ESA therapy are not included in the lower bound level that has been proven graft measure and, in the meantime, Hemoglobin Greater than 12 g/dL safe for all patients treated with ESAs, weight the catheter measure at 2⁄3 of the measure. and the state of evidence supporting VAT measure topic and the fistula Response: The measure rate is such a lower bound remains weak. For measure at 1⁄3 of the VAT measure topic. calculated using claims that include a these reasons, we believe that the Other commenters urged us to take a hemoglobin level and ESA dosing rationale for removing the Hemoglobin ‘‘fistula first, catheter last’’ approach information. Less Than 10 g/dL measure from the that would award some points for Comment: Several commenters ESRD QIP measure set remains valid. patients with grafts. Commenters were requested that we include a measure in However, we recognize that the also concerned that the fistula standards the ESRD QIP that establishes a floor for potential for ESA underutilization is an are too stringent and could cause hemoglobin, specifically noting that, important issue. As noted in the CY unintended consequences such as because of the bundle, there may be a 2012 ESRD PPS final rule (76 FR 70257), ‘‘cherry-picking’’ patients who are not perceived financial incentive to we will continue to monitor the eligible for a fistula. Commenters underutilize ESAs. They argued that Medicare ESRD population for evidence suggested that we exclude or allow studies have shown that as hemoglobin of underutilization of ESAs, a rise in doctors to exclude certain patients from drops below 10, mortality and blood transfusions, and the replacement the measure’s denominator providing hospitalization increase, and that of ESA therapy with transfusions. for more individualized care, noting that hemoglobin levels affect a patient’s Although we are no longer including the studies show that facilities are unlikely quality of life (both empirically and Hemoglobin Less than 10 g/dL measure to ‘‘game’’ such an exception. anecdotally). Some commenters stated in the ESRD QIP (and will no longer be Response: As discussed in the CY that we should reinstate the Hemoglobin publicly reporting it on DFC beginning 2011 ESRD PPS Final Rule, we continue Greater than 10 g/dL measure that we January 2013), the results will be to believe that the VAT measure topic used in the PY 2012 ESRD QIP, arguing available via a downloadable file for and its respective weights incentivize that the measure is reliable and is facilities to provide for continued the best care for ESRD beneficiaries (76 consistent with the FDA-approved monitoring of the measure. Finally, we FR 70265, 70275). Catheters are labeling which recognizes the continue to work with stakeholders undesirable due to their high rate of importance of transfusion avoidance through a consensus-based measure complications, such as infections, and and recommends that initiation of ESA development process to produce we discourage their use through the therapy be considered when the measures capable of addressing ESA catheter measure. We believe that the hemoglobin level falls below 10 g/dL. underutilization and blood transfusions, preferred type of vascular access is an One commenter argued that patients while remaining consistent with the AV fistula due to lower rates of should be allowed to make decisions existing relevant guidelines and complications, which we promote about their quality of life and safety, evidence base. through the fistula measure. Although even if that means keeping the We also appreciate comments grafts do decrease the risk of infections hemoglobin level higher than encouraging us to move toward and complications when compared to recommended. Other commenters noted implementing quality of life and other catheters, grafts do not decrease these that patients with hemoglobin less than patient-centered measures that address risks as much as fistulae. We, therefore, 10 g/dL are increasing, as are the rate of anemia management. These do not believe that grafts are either transfusions, and increased transfusions measurement domains are important to beneficial enough to be specifically can decrease the chances of a successful us and we plan to develop appropriate rewarded or harmful enough to be transplant; in turn, failed transfusions measures to be implemented in the specifically penalized. Furthermore, we can increase the cost of care since ESRD QIP during future rulemaking. do not believe it is in the best interest patients with transplants cost less than For the reasons stated above, we will of patients to weight the fistula measure those on dialysis. One commenter stated continue to use the Hemoglobin Greater more than the catheter measure because that we should specifically consider than 12 g/dL measure for PY 2015 and our primary goal is to promote fistula reinstituting a hemoglobin floor if the future years of the ESRD QIP. The use; we believe that both measures are United States Renal Data Service technical specifications for this equally important in promoting the best information shows that transfusion rates finalized measure can be found at clinical practices with respect to VAT. have risen significantly. Other http://www.dialysisreports.org/pdf/esrd/ We recognize that the catheter commenters suggested that even if we public-measures/AnemiaManagement- measure could incentivize ‘‘cherry- do not adopt a measure for low HGB-2015-FR.pdf picking’’ of patients, leading to access to hemoglobin, we report hemoglobin care issues for patients with catheters. b. Vascular Access Type (VAT) Measure levels, transfusion rates, and ESA We are actively monitoring access to Topic dosage on DFC and include the care and other potential issues Hemoglobin Less than 10 g/dL measure Comment: Many commenters strongly associated with ‘‘cherry-picking,’’ and it on DFC. Finally, other commenters supported our continued inclusion of is our intent to engage the community urged us to continue to monitor and the VAT measure topic in the PY 2015 as we monitor these issues. support metrics such as transfusions, ESRD QIP. Many commenters, however, Comment: One commenter quality of life, reactivity to antibodies also expressed concern that the encouraged us to promote fistulae in preventing transfusions, and composite measure over-emphasizes pediatric patients as well as adults. underutilization of ESAs. fistulae, underemphasizes grafts, and, Response: We thank the commenter Response: We thank the commenters therefore, promotes inappropriate care who encouraged the promotion of for bringing to us their concerns about in some cases. Commenters noted that fistulae use in pediatric patients. The the ESRD PPS payment bundle fistulae are not suitable for some NQF-endorsed fistula measure excluded potentially increasing the risk for patients, fistulae take time to mature, pediatric patients. Children on chronic underutilization of ESA therapy. As and grafts are sometimes the most dialysis have a fundamentally different noted in the CY 2012 ESRD PPS final clinically appropriate. Several psychosocial profile than adults. Fistula rule (76 FR 70257), we could not at the commenters asked us to decrease the use, with its attendant frequent painful time identify a specific hemoglobin emphasis on fistulae by developing a needle sticks are less commonly used in

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children than adults. In addition, there how the survey is administered. For purposes of scoring clinical measures are technical issues that make fistula example, as the specifications indicate,3 based on the same data in subsequent creation more difficult in children. We patients may take a break during the payment years and want to adopt a will continue to investigate whether administration of the survey or take the minimum reporting threshold that we there are measures in existence or that survey in multiple sittings if they feel can apply to all measures. For these could be developed for the purpose of that the number of questions is too great reasons, we are finalizing that facilities appropriately addressing vascular to answer at one time. Finally, we do must attest to administering the ICH access among pediatric patients and not believe that facilities should be CAHPS survey if they treat during the may propose to adopt one or more of permitted to give patients the survey at performance period at least 11 adult, in- these measures in future rulemaking. the facility and allow patients to submit center hemodialysis patients. We also For the reasons listed above, we will these surveys via a ‘‘drop box’’ or any finalize that we will consider a facility continue to use the VAT measure topic other method. We believe that patients to have met the 11 patient threshold for PY 2015 and future years of the are much more likely to truthfully unless it affirmatively attests in ESRD QIP. The technical specifications respond to the surveys if they are CROWNWeb that it treated 10 or fewer for the finalized measures in this perceived to be in no way connected to in-center, adult hemodialysis patients measure topic can be found at http:// the facility; providing the surveys at the during the performance period. If a www.dialysisreports.org/pdf/esrd/ facility and allowing patients to return facility does not affirmatively attest to public-measures/VascularAccess- them by any means may lead to the having treated 10 or fewer in-center, Catheter-2015-FR.pdf and http:// patient to believe that his or her answers adult hemodialysis patients during the www.dialysisreports.org/pdf/esrd/ can be traced to him or her, and this performance period, we will score it on public-measures/VascularAccess- thought may bias the surveys. Thus, we this measure. Additionally, we are Fistula-2015-FR.pdf. believe that this survey as it is currently applying this policy to the NHSN c. In-center Hemodialysis Consumer specified is the best method available at Dialysis Event reporting measure, Assessment of Healthcare Providers and this time to measure patient experience. discussed below, because we intend to We thank commenters for bringing to Systems (ICH CAHPS) use the data from that measure to adopt our attention the hardships homeless a clinical measure in subsequent Comment: Many commenters patients may face in accessing the payment years. Unlike the ICH CAHPS supported the measure in its entirety. survey. Although we believe that the measure, the NHSN measure applies to Many commenters supported survey most accurately represents both adult and pediatric in-center monitoring patients’ experiences, but patients’ experiences of care at this hemodialysis patients. Therefore, we believe the ICH CAHPS survey, with 57 time, we will continue to evaluate how finalize that a facility must treat at least questions, is too burdensome and we can accurately capture all patient 11 in-center hemodialysis patients lengthy for beneficiaries to complete. populations, including the homeless. (whether adult or pediatric) during the These commenters requested that we Comment: One commenter suggested performance period to be scored on the minimize this burden and suggested that CMS define a threshold for patients NHSN Dialysis Event reporting measure. that the ICH CAHPS survey be parsed at which a facility would not need to To be considered a facility which has into three parts, with each patient administer the survey. treated 10 or fewer in-center receiving one of these parts and a group Response: We recognize that there are hemodialysis patients (whether adult or of core questions. Commenters also many small dialysis facilities for which pediatric) during the performance suggested that CMS allow facilities to hiring a third-party administrator to period, the facility must make an give patients the survey and allow fulfill the ICH CAHPS survey attestation in CROWNWeb to this effect. patients to return surveys via a ‘‘drop- requirements is impractical or If a facility does not make this box’’ at the facility or by mail to the prohibitively costly. Therefore, attestation, we will score it on this third-party administrator; commenters beginning PY 2015, we will exempt any measure. believe this approach will improve the facilities that have treated (whether that Comment: One commenter expressed response rate as patients are less likely patient was visiting the facility or concern that patients often do not to ignore the survey and one commenter otherwise) 10 patients during the answer the surveys honestly for fear of noted that, without such an approach, performance period or fewer that are retaliation and the validity of the survey the experiences of homeless patients qualified to take the survey. Patients are should be questioned. will not be recorded. qualified to take the survey if they are Response: We recognize that patients Response: As we noted in the 2012 adult, in-center hemodialysis patients. may feel pressure to answer questions in ESRD PPS Final Rule, we continue to We believe that 11 patients (regardless the survey favorably. We believe, believe that assessing the experiences of of the number of times these patients however, this concern is mitigated patients is vital to quality care (76 FR were treated) is an appropriate because under the measure 70269 through 70). Patient surveys can, threshold for applying the measure specifications, a third-party must and should, draw a facility’s attention to because it is consistent with the policy administer the survey. These third-party issues that can only be raised by those that we are finalizing for all measures in administrators are not associated with receiving care. Although commenters which we recognize that facilities with facilities and do not report patient- may consider the survey to be 10 or fewer patients in the denominator specific data to the facilities. Therefore, burdensome to patients, the CAHPS tool of a measure should be exempt from the facility would have no knowledge of went through extensive testing during that measure. Although we are not patient’s answers. development including focus groups requiring facilities to submit actual ICH Comment: Several commenters and one-on-one patient sessions which CAHPS data at this time, we are expressed concern about CROWNWeb’s assessed this burden and created considering collecting it in the future. ability to provide an adequate reporting specifications accordingly. Furthermore, We also intend to use the information system for this measure. we believe that concerns about patient collected from reporting measures for Response: CROWNWeb was launched burden can be at least partially nationally in June of 2012, and we mitigated without decreasing the 3 See https://www.cahps.ahrq.gov/content/ recognize that some facilities may still number of questions on the survey or products/ICH/PROD_ICH_Intro.asp?p=1022&s=222. be familiarizing themselves with the

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new system. As discussed, facilities are whether they should be refined before public-measures/ICHCAHPS-2015- not required to report ICH CAHPS data we propose to adopt this survey as an FR.pdf. to CROWNWeb or any other system; outcome-based measure. Regarding the 2. Expansion of Two PY 2014 Measures they are only required to make an survey questions, the majority of the for PY 2015 and Subsequent PYs attestation that they administered the survey is limited to questions about the surveys according to the specifications. facility. Only seven of the 58 core As stated earlier, we believe it is The attestations for the ICH CAHPS questions are about the patients’ important to continue using measures measure for PY 2015 are not due until nephrologists. There are 22 questions from one payment year to the next the end of January 2014. We have no about the staff at the facility (not payment year of the program to reason to believe that the attestation including the doctor), three about the encourage continued improvements in function will not be ready by the end of center, and nine about treatment; the patient care. Therefore, we proposed to January 2013, the PY 2014 deadline. We remaining questions capture expand the requirements under two believe that by this time, facilities’ demographic information. The reporting measures that we adopted for transition period should have ended, continuous care received by dialysis the PY 2014 ESRD QIP. These proposed and facilities will be able to successfully patients makes them keenly aware of expanded requirements would apply to submit their attestations. Therefore, their primary doctors’ involvement. To the measures for PY 2015 and because the attestations should be ready the extent that the questions are about subsequent payment years of the ESRD in CROWNWeb by January 2013 for the the physician, we believe that they are QIP. PY 2014 ESRD QIP, they should also be appropriate because they are targeted at a. Expanded National Healthcare Safety available in CROWNWeb for the PY the nephrologist who is most involved Network (NHSN) Dialysis Event 2015 program. in the patient’s dialysis care. Reporting Measure Comment: Many commenters noted Comment: Commenters requested that that the ICH CAHPS measure’s third- we develop new measures of patient’s Hospital Acquired Infections (HAIs) party administration requirement experiences. One commenter argued are a leading cause of preventable imposes significant costs on facilities that a measure should be developed that mortality and morbidity across different and that facilities should be allowed to evaluates a patient’s experience during settings in the healthcare sector, include these costs in their cost reports. each dialysis session because each including dialysis facilities. In a Response: Facilities may report experience can vary, and further argued national effort to reduce HAIs outcome, allowable operating expenses in their that this type of evaluation would allow HHS agencies, including CMS and the Medicare cost reports. We believe that it facilities to better assess why patients Centers for Disease Control and is consistent with this payment policy do not stay for entire treatments or miss Prevention (CDC) are working together for facilities to include the ICH CAHPS treatments. Many commenters requested to encourage facilities to report to the costs on their cost reports because they that we develop a CAHPS measure for NHSN as a way to track and facilitate are allowable operating expenses. home hemodialysis and peritoneal action intended to reduce HAIs. The Comment: Several commenters urged dialysis patients. Commenters also NHSN is currently a secure, internet- us to adopt the ICH CAHPS measure as suggested that we make the responses to based surveillance system that an outcome measure rather than a the surveys public. integrates patient and healthcare reporting measure. One commenter Response: We remain dedicated to personnel safety surveillance systems believes that, if we cannot implement developing and adopting measures of managed by the Division of Healthcare the measure as an outcome measure for patient experiences of care in the ESRD Quality Promotion at the CDC. NHSN PY 2015, we should do the following in QIP, specifically those patients who are has been operational since 2006 and order to facilitate our adoption of an treated at home. At this time we cannot tracks data from acute care hospitals, ICH CAHPS outcome measure as soon operationally make the responses to the long-term care hospitals, psychiatric as possible: (i) Develop a standardized ICH CAHPS survey public because, as hospitals, rehabilitation hospitals, protocol and quality assurance noted above, we do not possess the data; outpatient dialysis centers, ambulatory guidelines for survey administration however, we will consider making these surgery centers, and long term care that are more detailed than the AHRQ surveys public in future years if facilities. We believe that reporting requirements; (ii) contract with an facilities are required to submit their dialysis events to the NHSN by all experienced organization that can ICH CAHPS data to CMS. facilities supports national goals for provide oversight for the ICH CAHPS For the reasons discussed above, we patient safety, particularly goals for the program; and (iii) approve survey are finalizing the ICH CAHPS reporting reduction of HAIs. vendors. Another commenter argued measure for use in the PY 2015 ESRD For the reasons stated above, we that the survey should be limited to QIP and future years of the program. We proposed to retain the NHSN Dialysis questions about the facility rather than are also finalizing that the measure Event reporting measure that we the physician. applies to facilities that treat a adopted for the PY 2014 ESRD QIP (76 Response: Currently, we are not able minimum of 11 in-center, adult FR 70268 through 70269), but with an to include the ICH CAHPS survey as an hemodialysis patients during the expanded reporting period. For PY outcome measure because we do not performance period. We will consider a 2014, ESRD facilities were required to: possess data from which we can set facility to have met the 11 in-center, (i) Enroll in the NHSN and complete performance standards. We believe that adult hemodialysis patient threshold any training required by the CDC related it is important to adopt an outcome- unless it affirmatively attests in to reporting dialysis events via the based measure as soon as possible, and CROWNWeb to having treated 10 or NHSN system; and (ii) submit three or we are diligently working to ensure that fewer adult, in-center hemodialysis more consecutive months of dialysis it is a part of the program as soon as patients during the performance period. event data to the NHSN. For the PY possible. To that end, we will be If a facility does not make the 2015 ESRD QIP and future payment working to set up a survey vendor attestation, we will score it accordingly. years, we proposed to retain the NHSN approval program; we believe that the The technical specifications for this measure and expand the reporting specifications are appropriately finalized measure can be found at period to a full 12 months of dialysis detailed, but we will continue to assess http://www.dialysisreports.org/pdf/esrd/ event data. Although we expect most

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facilities to have enrolled and trained in blood cultures. This measure differs NHSN system is yet another Web site to the NHSN dialysis event system by the from the dialysis event reporting which ESRD facilities must report, end of CY 2012, we proposed that measure that we adopted for the PY reducing time staff can spend caring for facilities that have not done so by 2014 ESRD QIP and proposed to expand patients. Finally, some commenters January 1, 2013 or facilities that receive beginning with the PY 2015 program support the expansion of the measure, a CMS certification number (CCN) because it evaluates the number of but only if the required monthly during 2013 must enroll and complete hemodialysis outpatients with positive reporting is at the facility rather than the this training before reporting the data in blood cultures over a specified time patient level. order to fulfill the requirements of this period. By contrast, the NHSN Dialysis Response: We do not believe that this reporting measure. The information Event reporting measure that we measure is unnecessarily burdensome. reported to NHSN would be provided by proposed assesses facilities based on Monitoring vascular access infections the CDC to CMS for use in the ESRD whether they enroll and report dialysis following uniform definitions and QIP. event data to the NHSN, not based on utilizing the comparative rate data to As discussed in more detail below, we what the data reported are. We intend evaluate and improve performance is proposed that the performance period to propose to adopt NQF #1460 once part of providing good patient care. for the PY 2015 ESRD QIP would be CY facilities have reported enough data to Although enrollment and training can 2013. We proposed that facilities must enable us to compute performance be time-consuming, approximately 90 report dialysis event data monthly to the standards, achievement thresholds, percent of all hemodialysis centers have NHSN for this measure. We also improvement thresholds, and already enrolled in NHSN. Furthermore, proposed that facilities be granted a benchmarks for the measure. we believe that any burden a facility ‘‘grace period’’ of one month to report For the reasons stated in the CY 2012 may face is outweighed by the these data. For further information ESRD PPS final rule (76 FR 70268 importance of this measure since regarding the NHSN’s dialysis event through 69), we proposed to retain the infections can often lead to serious reporting protocols, please see http:// measure and expand the reporting complications, including death. Further www.cdc.gov/nhsn/psc_da_de.html. period for PY 2015 and future payment to help decrease the burden, the CDC This link provides general information years of the program. We requested began allowing facilities to report to and links to more detailed, specialized comment on this proposal, and noted NHSN through imported CDA files on information. that the technical specifications for this September 14, 2012. Using this We note that this proposed measure measure are located at http://www. function, any individual with only applies to facilities treating dialysisreports.org/pdf/esrd/public- Administrative Rights for a facility will patients in-center. For purposes of the measures/NHSNDialysisReporting- be able to import that facility’s specific NHSN Dialysis Event reporting measure, 2015-NPRM.pdf. CDA files that meet NHSN’s formatting we determine whether a facility treats The comments we received on these requirements. This includes large patients in-center by referencing the proposals and our responses are set dialysis organizations that have given facility’s information in CMS data forth below. Administrative Rights to a single person sources (that is, SIMS and Comment: Many commenters for purposes of the entire (or some CROWNWeb). Facilities report the types supported the expansion of the NHSN portion of) the organization. However, at of patients that they serve in these data Dialysis Event reporting measure, this time each facility’s files must be sources. If a facility lists in-center stating that monitoring the number of submitted separately. Because we are services, we proposed that the facility patients with access-related infections aware that large dialysis organizations would be required to comply with the for an entire year will help the (as well as many other dialysis NHSN dialysis event reporting measure. community better understand ways to companies) have given Administrative Section 1881(h)(2)(B)(i) of the Act reduce infection rates. Some Rights to a single representative of the requires that, unless the exception set commenters expressed concern with organization, we recognize that they forth in section 1881(h)(2)(B)(ii) of the certain aspects of the measure. Several will eventually be able to submit CDA Act applies, the measures specified for commenters expressed their concern data for a number of individual the ESRD QIP under section about the burden of this measure, facilities, from a single central location, 1881(h)(2)(A)(iii) of the Act must have specifically highlighting the burden of all through a single batch submission been endorsed by the entity with a manual data-entry and the staff hours process. This batch data submission contract under section 1890(a) of the demanded for this entry and oversight; process is expected to be available in Act (which is currently NQF). Under the one commenter noted that NQF criteria August 2013. Finally, the monthly exception set forth in 1881(h)(2)(B)(ii) of related to feasibility favor electronic reporting required by the NHSN is at the the Act, in the case of a specified area collection and data collected during the facility level. Facility-level review of the or medical topic determined appropriate course of care. Commenters argued data in NHSN is expected, whether the by the Secretary for which a feasible and further that manual data entry affects data are reported by facility staff or by practical measure has not been endorsed reliability, further affecting the baseline a corporate representative. We believe by the entity with a contract under calculations for future measures. Many that facilities have a direct role in section 1890(a) of the Act, the Secretary commenters suggested a batch preventing infections by collecting the may specify a measure that is not so download system. Some commenters NHSN Dialysis Event data, actively endorsed so long as due consideration is noted that the CDC intends to make a assessing their data, and regularly given to measures that have been Clinical Document Architecture (CDA) feeding back this information to clinical endorsed or adopted by a consensus system available for batch entries, but staff to improve practices. organization identified by the Secretary. expressed concern that the CDC CDA Comment: One commenter argued An NQF-endorsed bloodstream system will be available for individual that the NHSN Dialysis Event reporting infection measure (NQF#1460) exists facilities only (rather than for an entire measure will not improve care because and is collected by the CDC as part of corporation); others stated that they did the system is not efficient and is not dialysis event reporting in NHSN. This not believe the CDA system will be correlated to CROWNWeb. Many measure assesses the number of ready for data entry by the end of CY commenters urged us to synchronize hemodialysis patients with positive 2012. Commenters also stated that the NHSN and CROWNWeb data

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requirements. Commenters also possible. However, to maximize data concerns while we consider adopting a requested that CMS continue to use the completeness and accuracy, facilities measure based on NHSN data for future same reporting schedule for PY 2015 as will be allowed to add to and modify years of the program. it will for PY 2014, allowing facilities to the reported data until the performance Comment: One commenter requested report quarterly with all data being period reporting deadline. Data for the clarification regarding whether facilities required by March 31, 2014. entire performance period must be are required to report infections Commenters noted that quarterly reported by April 15, 2014. We chose occurring in the dialysis unit only, reporting is important because this April 15, 2014 because this date allows exempting the facilities for infections timeframe will allow facilities ample facilities a full quarter after the that result from care in other time to submit data correctly, stating performance period to review their data environments. that some infections take more than a for completeness and accuracy. After Response: The measure specifications, month to identify and capture. One consulting with the CDC, we believe which are available at (http:// commenter recommended that we that such a timeframe will maximize the www.cdc.gov/nhsn/PDFs/pscManual/ modify the requirements of this reliability of the data and allow facilities 8pscDialysisEventcurrent.pdf), provide provision to allow a facility to report a to report any infections that developed that positive blood cultures occurring full 12 months of data by January 31, during the performance period but that within one calendar day after a hospital 2014. Other commenters urged us to are identified after the performance admission must also be reported. For ensure that the NHSN Dialysis Event period has ended. further clarification on reportable event reporting measure allows the NHSN Comment: One commenter is definitions and considerations system to remain a surveillance system. concerned with the proposed expansion surrounding attribution, please contact Response: We disagree with the of this measure if NHSN data is not the NHSN help desk ([email protected]). comment that the NHSN Dialysis Event validated or audited for completeness. Comment: One commenter asked us reporting measure will not improve This commenter expressed specific to confirm that, as long as the census care. Requiring facilities to report concern that there could be surveillance data is reported every month, the through the NHSN will allow us to bias in interpreting submitted data. facility may attest to having met the monitor and better understand the Response: We recognize that bias requirements for the NHSN measure. causes of infections. Additionally, as we exists because some facilities may be Response: For the reasons discussed stated in the proposed rule (77 FR 40971 more likely to identify and report above, we finalize that a facility may through 72), we intend to use the dialysis events than others. Varying attest for purposes of being exempt from information gathered by this reporting degrees of completeness of the data reporting for the NHSN dialysis event measure to adopt a clinical measure in could lead to inaccurate comparisons measure if it treats fewer than 11 in- future years; this measure will between facilities. The CDC and CMS center hemodialysis patients during the encourage facilities to decrease the are beginning to formulate a strategy to performance period. If a facility treats circumstances which lead to infections. validate data for purposes of the ESRD 11 or more in-center hemodialysis Although we intend to use data from the QIP; we are committed to rigorous patients, we will score the facility based NHSN to adopt a clinical measure, we validation to identify inaccuracies and on whether it reported data to the will work with the CDC to ensure that ensure reliability of the data. NHSN. the ESRD QIP does not unnecessarily Comment: One commenter suggested Comment: One commenter urged us limit the surveillance purposes of the that CDC standardize and clarify data to develop a measure which targets the NHSN system. definitions to ensure ‘‘apples-to-apples’’ cause of the infections. Another Commenters are correct in that the comparisons and allow corporate commenter suggested that CMS consider NHSN Dialysis Event reporting measure oversight of data entered into the system adding NHSN dialysis specific data is not correlated to CROWNWeb. for verification and reliability purposes. indicators, perhaps in stages, such as We recognize that CROWNWeb and the Another commenter stated that it does local access site infection, access-related NHSN are two distinct systems which not support the adoption of a future bloodstream infection, and vascular require reporting. At this time, we do NHSN Dialysis Event clinical measure access infection to the NHSN not require infection reporting in because facility policies and procedures surveillance data. CROWNWeb. We believe that it is more and physician practices vary widely Response: We thank commenters for beneficial for both facilities and CMS to with respect to the circumstances under these suggestions. We acknowledge that require infection reporting through the which blood cultures are obtained and preventing and monitoring infections is NHSN. The NHSN is a well-established results are reported; this commenter crucial to patient care. We will continue secure, internet-based surveillance requested that reporting be standardized to work with the dialysis community to system that integrates patient and before the measure is adopted. include robust infection measures in the healthcare personnel safety surveillance Response: The CDC develops ESRD QIP. systems managed by the Division of protocols, definitions, and criteria for Comment: Many commenters support Healthcare Quality Promotion at the the purposes of standardizing reporting, our proposed transition of the NHSN CDC; it is used by many other types of and expects that all NHSN users strictly Dialysis Event reporting measure to a providers to report infections. We adhere to the protocol guidance for data clinical measure using the NQF- believe that NHSN’s history and wide- that are reported into NHSN. The endorsed measure #1460. Some spread surveillance make it the best dialysis event surveillance reporting commenters urged us to adopt the mode of reporting dialysis events at this protocol is available on CDC’s NHSN clinical measure in PY 2015. Other time. Web site and includes data definitions commenters, however, suggested that We do not agree with commenters’ (http://www.cdc.gov/nhsn/PDFs/ we allow sufficient time to ensure that suggestions to extend the reporting pscManual/ NHSN data can be reported without timeline for the PY 2015 NHSN Dialysis 8pscDialysisEventcurrent.pdf). Users additional burden to providers. One Event reporting measure. The NHSN may contact the NHSN help desk commenter suggested that, once the system recommends monthly reporting, ([email protected]) for clarifications to measure is adopted as a clinical and we believe it is important to adhere these data definitions. We will continue measure, we interpret the rate of to the NHSN requirements as much as to work with the CDC to monitor these positive blood cultures against the

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facility’s rate of empiric antibiotic this attestation, we will score it once per month so that each beneficiary treatment, since some facilities treat accordingly. Additionally, we receives the highest standard of care. empirically rather than through taking recommend that facilities report We noted, however, that there are blood cultures. monthly to the NHSN. Data for the circumstances beyond a facility’s Response: We thank commenters for entire performance period must be control wherein it may not be able to supporting our proposal to adopt the reported by April 15, 2014. The draw a sample for this patient. NQF-endorsed infection measure for technical specifications for this Therefore, we did not propose that the future years of the program. We are finalized measure can be found at facility itself must draw the serum unable to adopt the NQF-endorsed http://www.dialysisreports.org/pdf/esrd/ phosphorus and serum calcium levels. clinical measure for PY 2015 because public-measures/ If, for example, a patient is hospitalized we have not yet gathered data on which NHSNDialysisReporting-2015-FR.pdf. or transient during a claim month, we we can base performance standards. For proposed that the facility may report the b. Expanded Mineral Metabolism purposes of the ESRD QIP, facilities serum calcium and serum phosphorus Reporting Measure began reporting to the NHSN during readings for the patient for a month if 2012; to receive full points on the Undertreatment of bone mineral a patient has labs drawn by another measure for PY 2014, facilities need metabolism disease can cause severe provider/facility and those labs are only to report three months of data. We consequences for ESRD patients. For PY evaluated by an accredited laboratory (a do not believe it is appropriate to base 2014, it was not yet feasible for us to laboratory that is accredited by, for performance standards on three months adopt a clinical measure evaluating example, the Joint Commission, the of data for purposes of an infection facilities based on their patients’ bone College of American Pathologists, the measure because infections can vary by mineral metabolism rates because AAB (American Association of season. We believe that using a 12- facilities did not report serum Bioanalysts), or State or Federal agency), month period for setting these standards phosphorus and serum calcium values and the dialysis facility obtains the will prove more accurate. Because we during the baseline and performance serum calcium and serum phosphorus are requiring 12 months of data for the periods that we finalized with respect to readings. Additionally, we proposed to PY 2015 ESRD QIP, we believe we can that year. Instead, for PY 2014, we only consider a patient qualified for this use this information to adopt standards finalized a measure assessing whether measure (i) if the patient is alive at the for a clinical measure in future years. facilities routinely monitored the serum end of the month; (ii) if the patient is Additionally, we agree with the calcium and serum phosphorus levels in treated in-center, that patient was commenters who believe that it may be their patients. For PY 2015, we treated at that facility at least twice necessary for facilities to become more proposed to expand this measure by during the claim month; and (iii) if the familiar with the NHSN system before requiring facilities to report a serum patient receives dialysis at home, a we adopt a clinical measure. calcium and serum phosphorus level for claim is submitted for that patient. We We thank the commenter who each qualifying patient each month stated our belief that that these suggested that we interpret the rate of according to the requirements in proposals will provide more flexibility positive blood cultures against the CROWNWeb. Facilities would be for facilities and will also discourage facility’s rate of empiric antibiotic required to enter these values into facilities from drawing blood, even treatments to account for facilities that CROWNWeb on a monthly basis. when not necessary, for fear that the might treat patients empirically for Facilities would be granted a ‘‘grace patient will fail to come to the facility infection without drawing cultures. The period’’ of one month to enter the data. again during that month. We requested NHSN collects information on IV For example, we would require a facility comment on these proposals. We also antimicrobial starts, in part, for this to report serum calcium and serum requested comment on whether reason. Providers are expected to adhere phosphorus data for January 2013 on or facilities should only have to report data to standards of clinical practice, which before February 28, 2013. The final for 98 percent of their patients. include obtaining blood cultures prior month of data from the performance Section 1881(h)(2)(B)(i) of the Act to antibiotic administration for period would be reported on or before requires that, unless the exception set suspected bloodstream infections. January 31, 2014. forth in section 1881(h)(2)(B)(ii) applies, Comment: One commenter stated its We do not intend for this measure to the measures specified for the ESRD QIP support for the adoption of an MRSA encourage unnecessary testing or under section 1881(h)(2)(A)(iii) of the standardized infection rate clinical unduly burden a facility. Consequently, Act must have been endorsed by the measure. for purposes of scoring the measure, we entity with a contract under section Response: We thank the commenter considered proposing to require 1890(a) of the Act (which is currently for providing this suggestion and will facilities to report the required NQF). Under the exception set forth in take it into consideration in future information for less than 100 percent of 1881(h)(2)(B)(ii) of the Act, in the case measure development and rulemaking. their patients. Specifically, we of a specified area or medical topic For the reasons stated above, we considered lowering the threshold to determined appropriate by the Secretary finalize the NHSN Dialysis Event reporting 98 percent of patients for a for which a feasible and practical reporting measure as proposed except month in order to receive credit for that measure has not been endorsed by the for the following; a facility must treat at month. We chose 98 percent in order to entity with a contract under section least 11 in-center hemodialysis patients encourage improvement, and to ensure 1890(a) of the Act, the Secretary may (both adult and pediatric) during the that we do not undermine the current specify a measure that is not so performance period to be scored on the level of high-reporting (based on the endorsed so long as due consideration is NHSN Dialysis Event reporting measure, CROWNWeb pilot data). We recognize given to measures that have been as noted above. To be considered a that 100 percent might not be endorsed or adopted by a consensus facility which has treated 10 or fewer in- appropriate due to some individual organization identified by the Secretary. center hemodialysis patients during the cases that may not fit specified criteria. An NQF-endorsed measure assessing performance period, the facility must We ultimately proposed that a facility hypercalcemia exists (NQF #1454) and make an attestation in CROWNWeb to should be required to take and report we proposed to adopt this measure for this effect. If a facility does not make these values for every patient at least the PY 2015 ESRD QIP and subsequent

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payment years, as further discussed for all of the reporting measures, the blood for every patient for the first few below. The NQF-endorsed following patients: (i) Beneficiaries who visits of the month. Based on these hypercalcemia measure, however, does are regularly treated at the facility and considerations, we will not finalize our not score facilities based only on who fit into one of these categories: (a) proposal to exclude only in-center whether or not that facility reported Beneficiaries who die within the patients who have been treated fewer serum calcium values. The Mineral applicable month; (b) beneficiaries that than two times by the facility during the Metabolism reporting measure, unlike receive fewer than 7 treatments in a claim month. Instead, we will exclude the Hypercalcemia measure, would month; and (c) beneficiaries receiving any in-center patient who is treated by assess only whether facilities report home dialysis therapy who miss their the facility fewer than seven times serum calcium and serum phosphorus in-center appointments when there is a during the reporting month. values. It would not score facilities documented, good faith effort to have We do not believe that it is necessary based on the actual values that they them participate in such a visit during to specifically exclude transient patients report. We stated our belief that it is the applicable month; (ii) transient from this measure because, as noted, important to continue to encourage dialysis patients; (iii) pediatric patients any patient that is treated by the facility reporting independent of a measure that (unless the measure is specific to this at least seven times during the scores based on the actual values population); and (iv) kidney transplant applicable reporting month is present at reported because we need such values recipients with a functioning graft. the facility for enough time that the to monitor aspects of bone mineral Commenters stated that these exclusions facility should be held accountable for metabolism, for example phosphorus are consistent with our own measures that patient. Likewise, for the same management, independent of reported on DFC. Additionally, reasons mentioned above, we do not hypercalcemia; we noted that this commenters stated that these exclusions believe we need to separately exclude information will allow us to develop seek to hold facilities accountable only patients who are deceased at the end of comprehensive bone mineral for those beneficiaries to whom they the reporting month. Provided that the metabolism measures for use in future regularly give care and for whose care patient is treated by the facility at least years of the ESRD QIP. they can affect. Another commenter, seven times during that month, the In the CY 2012 ESRD PPS final rule, however, stated that we should not facility should be able to draw blood we discussed the basis for the Mineral implement other commenters’ necessary to report serum calcium and Metabolism reporting measure (76 FR suggestions that we exclude serum phosphorus levels even if that 70270 through 71). We stated that ‘‘the beneficiaries receiving home dialysis patient is deceased at the end of the NQF has previously endorsed therapy who miss their in-center month. phosphorus and calcium monitoring appointments when there is a We continue to believe that facilities should be required to report the serum measures (NQF #0261 and NQF #0255) documented, good faith effort to have calcium and phosphorus levels of home and, in 2008, we adopted serum calcium them participate in such a visit during dialysis patients irrespective of whether and serum phosphorus monitoring as the applicable month; this commenter those patients attend a monthly Clinical Performance Measures (http:// stated that it is the responsibility of the appointment. We believe that it is www.dialysisreports.org/ facilities to educate patients on the incumbent upon a facility to make home ESRDMeasures.aspx).’’ The NQF importance of making and keeping dialysis patients aware that they must measures referenced above call for appointments. Additionally the attend monthly appointments to be monitoring these serum calcium and commenter argued that ‘‘good faith’’ is serum phosphorus values, but they do properly treated. In addition, since the too vague; commenter requested that, if not require actual reporting of these mechanisms that cause cardiovascular we did adopt this exclusion, we clearly values, as is the intent of the Mineral and bone disease do not differ between define a ‘‘good faith effort.’’ Metabolism reporting measure. home and in-center hemodialysis For these reasons, we proposed to Response: Upon further review, we patients, we believe that the inclusion of expand the Mineral Metabolism agree with commenters who believe that home dialysis patients in the Mineral reporting measure for PY 2015 and the exclusions should be modified. We Metabolism reporting measure is subsequent payment years under recognize that treating a patient twice appropriate. Therefore we will finalize 1881(h)(2)(B)(ii) of the Act. The may not provide enough time to our proposal that we will include any technical specifications for this measure effectuate quality patient care. We agree home hemodialysis patient for which a can be found at http:// with the commenters who suggested facility submits a claim with respect to www.dialysisreports.org/pdf/esrd/ that an in-center hemodialysis patient the reporting month in this measure. public-measures/MineralMetabolism- should be excluded if treated by a We also believe it is important to Reporting-2015-NPRM.pdf. We further facility fewer than seven times during include transplant patients until they noted that requiring the reporting of the month, regardless of whether the are officially discharged from a facility; serum calcium and serum phosphorus patient is officially admitted to that regular monitoring can help ensure that levels for the PY 2015 ESRD QIP will facility. With seven treatments, we a transplant remains effective and that allow us to develop mineral metabolism believe that a facility should have had the facility is continuing to provide the measures based on clinical data in the adequate opportunities to draw blood best care possible. future. We requested comment on these necessary to report serum calcium and We believe it is important to monitor proposals to expand the Mineral phosphorus levels. We also believe that serum calcium and serum phosphorus Metabolism reporting measure. the threshold of seven will discourage levels in adult and pediatric patients The comments we received on these unnecessary testing of in-center alike because improper bone mineral proposals and our responses are set hemodialysis patients by facilities metabolism management can lead to forth below. because they will know that, since in- serious, negative outcomes, including Comment: Many commenters center patients are typically treated death, in both populations. Although we generally supported this measure, but three times per week, a patient must are aware that specific target values for requested that we make modifications to have been treated by the facility for at calcium and phosphorus have not been our proposed exclusions. These least two weeks to be included; thus, the set for the pediatric population, we still commenters suggested that we exclude, facility need not feel pressure to draw believe that this measure will lead to

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better observation of mineral the CROWNWeb pilot was mainly 2015. One commenter argued that it is metabolism in these patients if one or supplied by LDOs that may be more inappropriate to adopt this measure both of these values are unusually high likely to have more resources and because it is not-NQF endorsed, nor. or low. Additionally, we believe that the corporate policies that require reporting One commenter stated that it is inclusion of pediatric patients in this compliance. Furthermore, such a high inappropriate to adopt this measure measure is consistent with current percentage requirement may under the exception set forth in the guidelines on the frequency of mineral disadvantage small facilities. For statute for measures which are not NQF- metabolism testing as reported in example, if a facility has 10 patients, endorsed; this commenter stated that KDIGO guidelines chapter 3 ‘‘Diagnosis failure to report for one patient will the NQF process ensures that measures of CKD–MBD: biochemical drop that facility’s reporting rate to have gone through a rigorous evaluation abnormalities.’’ Thus, we believe that below 90 percent. process, including reliability and this measure is appropriate for both Taking all of these issues into validity. Some commenters argued that adult and pediatric patients. consideration, we finalize a normative this measure should be deferred because For the reasons stated above, we reporting threshold for this measure; we have not articulated the intent of the finalize that facilities must report in facilities will be required to report at the data collection or explained the measure CROWNWeb the serum calcium and rate of the 50th percentile of all facilities for which we intend to ultimately use serum phosphorus levels on a monthly in 2013 for each month of the these data. Several commenters do not basis for (i) in-center Medicare patients performance period in order to gain 10 support this measure because facilities who have been treated at least seven points on the measure. However, if the already collect these data so the times by the facility; and (ii) home 50th percentile of all facilities in 2013 measure is unlikely to improve care, hemodialysis Medicare patients for is greater than 97 percent, facilities will and they requested that we adopt a whom the facility submits a claim. only be required to report monthly for measure based on outcomes. One Comment: Several commenters 97 percent, in total, of their (i) in-center commenter does not support adoption encouraged us to not adopt a percentage Medicare patients who have been of this measure because, it contends, reporting threshold because it would treated at least seven times by the Kidney Disease: Improving Global not distinguish between beneficiaries facility; and (ii) home hemodialysis Outcomes (KDIGO) has not indicated legitimately excluded and those that Medicare patients for whom the facility that serum calcium and serum were merely missed. Other commenters submits a claim. This floor ensures that phosphorus must be reported on a requested that we use both exclusions facilities are not penalized as long as monthly basis. Further, the commenter and a threshold; one commenter they improve by one percent above the argues that although it is customary to suggested a threshold of 90 percent or reporting rates in the CROWNWeb pilot; measure serum calcium and phosphorus an allowance of two patients to ensure that is, facilities know that, provided monthly, there is no evidence that it that small facilities are not they reach 97 percent for each month of indicates quality care. disproportionally affected. Another the performance period, they will meet commenter stated that requiring 98 the requirements of the measure. We Response: KDIGO recommends percent reporting may make it difficult believe that it is important to adopt a monthly measurements (see Table 13 on for patients to travel because dialysis reporting rate of 97 percent in PY 2015 internet document titled ‘‘Kidney facilities may encourage them otherwise to ensure continued improvement. We Disease Improving Global Outcomes to ensure compliance with the measure. believe that this methodology fairly Clinical Practice Guideline for the One commenter requested that we balances the concerns that the reporting Diagnosis, Evaluation, Prevention, and provide guidance regarding the in CROWNWeb is skewed with our Treatment of Chronic Kidney Disease- standardization of blood-draws so that desire to encourage continued Mineral and Bone Disorder (CKD– data can be reliable before we improvement in the community. MBD)’’ at http://www.kdigo.org/ implement a reporting threshold. We are concerned that small facilities guidelines/mbd/guide3.html#chap31)). Response: We agree with the may be disproportionately impacted by KDIGO also emphasizes the importance commenters who argued that, even with the reporting threshold because, for of following trends versus single exclusions, there are circumstances in example, a facility with 10 patients measurements, thus supporting which facilities cannot report the serum could fail to report for only one patient relatively frequent measurements (for calcium and serum phosphorus levels and, therefore, fail to meet the example, monthly). There is evidence for every patient at least once per threshold. As we have stated, we intend that calcium and phosphorus levels may month. For example, a facility may wait to use the information collected from be associated with clinical outcomes. to draw blood from a patient because it reporting measures for purposes of Monthly measurements will serve to believes that the patient will be treated scoring clinical measures based on the identify elevated levels of serum for the entirety of the month, but learns same data in subsequent payment years. calcium and phosphorus and trigger that the patient has been hospitalized Therefore, we will not require a facility therapeutic interventions, thus unexpectedly for all or part of the to report this measure if it treats fewer contributing to high quality care. applicable month. Therefore, we believe than 11 (i) in-center Medicare patients Because of these important that we should not require an attestation who have been treated at least seven considerations, and for the reasons of 100 percent monitoring. Based on times by the facility; and (ii) home stated above, we believe that it is data from the CROWNWeb pilot, we hemodialysis Medicare patients for important to adopt this measure even believe that facilities are generally able whom the facility submits a claim. If a though it is not NQF-endorsed. We to report serum calcium and serum facility does not treat at least 11 of these disagree that it is inappropriate to adopt phosphorus for approximately 96 patients during the performance period, a measure not endorsed by NQF under percent of their patients. As commenters it will be required to attest to this fact the exception set forth in the statute. We have argued, the information in via CROWNWeb. If a facility does not believe the exception language was CROWNWeb, however, was voluntarily make the attestation, we will score it intended for such a circumstance where reported which may mean that the data accordingly. an endorsed measure is not available for is biased toward facilities that value Comment: Some commenters did not implementation to address key issues reporting; additionally, the data from support including this measure in PY described in the statute, such as mineral

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metabolism. We will continue to work serum levels of parathyroid hormone in program. Kt/V is a widely accepted toward the development and the future. measure of dialysis adequacy in the implementation of appropriate, NQF- As explained above, we are modifying ESRD community because it takes into endorsed measures to support the ESRD our proposed exclusions and finalizing account the amount of urea removed QIP. that any facility must report serum with excess fluid. Further, while the Comment: Many commenters noted calcium and serum phosphorus levels URR Hemodialysis Adequacy measure that it is impractical for facilities to for all (i) in-center Medicare patients only applies to in-center hemodialysis obtain lab values from other providers who have been treated at least seven patients, we stated that the proposed Kt/ because other providers are not required times by the facility; and (ii) home V measures will allow us to evaluate to measure these data, do not share data hemodialysis Medicare patients for dialysis adequacy in adult hemodialysis with dialysis facilities, and, even if whom the facility submits a claim least (HD) patients (in-center and home facilities could obtain these data, they once per month via CROWNWeb at the hemodialysis (HHD)) receiving three could not be sure that the lab values lesser of the 50th percentile of facilities treatments weekly, adult peritoneal were consistent or reported under the in 2013 or 97 percent per month to dialysis (PD) patients, and pediatric HD same standards. Finally, these receive 10 points on the measure. We patients receiving three to four commenters stated that CROWNWeb also finalize that we will only apply this treatments weekly. We proposed to does not permit facilities to submit data measure to facilities with at least 11 (i) adopt the following NQF-endorsed Kt/V obtained from other providers if the lab in-center Medicare patients who have measures of dialysis adequacy, each one result is outside the admission or been treated at least seven times by the applicable to a different patient discharge date. facility; and (ii) home hemodialysis population: Response: We recognize that it may be Medicare patients for whom the facility (i) NQF #0249: Hemodialysis difficult for facilities to coordinate with submits a claim. Facilities who treat less Adequacy Clinical Performance hospitals and other care providers in than 11 of these patients during the Measure III: Hemodialysis Adequacy— order to obtain lab values. Therefore, we performance period must attest to this HD Adequacy—Minimum Delivered are not mandating facilities to do so. In fact in CROWNWeb. If they do not make Hemodialysis Dose; the CY 2013 ESRD PPS proposed rule this attestation, we will score them (ii) NQF #0318: Peritoneal Dialysis (77 FR 40969), we stated that facilities accordingly. The technical Adequacy Clinical Performance may obtain lab values from other specifications for this finalized measure Measure III—Delivered Dose of providers. This proposal was can be found at http:// Peritoneal Dialysis Above Minimum; specifically designed to afford facilities www.dialysisreports.org/pdf/esrd/ and more flexibility in acquiring and public-measures/MineralMetabolism- (iii) NQF #1423: Minimum spKt/V for reporting serum calcium and serum Reporting-2015–FR.pdf. Pediatric Hemodialysis Patients. The phosphorus values. As discussed proposed measures assess whether previously in this preamble, facilities 3. New Measures for PY 2015 and Medicare dialysis patients (PD, HD, and are highly encouraged to coordinate Subsequent PYs of the ESRD QIP pediatric hemodialysis) meet the with other providers, but the ESRD QIP As the program evolves, we believe it modality specific Kt/V threshold. does not mandate them to do so. We is important to continue to evaluate and Performance on the measures is believe that the commenters’ concerns expand the measures selected for the expressed as a proportion of patient- about inconsistent lab data are mitigated ESRD QIP. Therefore, for the PY 2015 months meeting the measure threshold. by the requirement that the lab must be ESRD QIP and subsequent payment The technical specifications for these accredited. Finally, the commenter is years, we proposed to adopt five new measures can be found at http://www. right in that CROWNWeb does not allow measures. The proposed new measures dialysisreports.org/pdf/esrd/public- facilities to submit data obtained from include: Three measures of dialysis measures/PediatricHemodialysis other providers if the lab result is adequacy (together comprising one Adequacy-ktv-2015-NPRM.pdf; http:// outside the admission or discharge date. dialysis adequacy measure topic); one www.dialysisreports.org/pdf/esrd/ As long as the patient is treated at least measure of hypercalcemia; and one public-measures/PeritonealDialysis seven times by the facility during the reporting measure related to hemoglobin Adequacy-ktv-2015-NPRM.pdf; and applicable reporting month, however, and ESA dosages for all patients. http://www.dialysisreports.org/pdf/esrd/ the facility will be required to report the a. Kt/V Dialysis Adequacy Measure public-measures/Hemodialysis patient’s serum phosphorus and Topic Adequacy-ktv-2015-NPRM.pdf. calcium levels regardless of whether the We requested comment on these patient also has blood drawn elsewhere Section 1881(h)(2)(A)(i) states that the proposals. The comments we received (for example, as a result of a ESRD QIP must evaluate facilities based on these proposals and our responses hospitalization) during the month. on measures of ‘‘dialysis adequacy.’’ For are set forth below. Comment: Many commenters PYs 2012 through 2014, the ESRD QIP encouraged us to monitor, in addition to included a hemodialysis adequacy i. Adult Hemodialysis Adequacy phosphorus and calcium, serum levels measure evaluating the number of Comment: The majority of of parathyroid hormone (PTH), arguing patients with a URR of at least 65 commenters strongly supported the that proper bone mineral management percent. For the PY 2015 ESRD QIP, and adoption of this measure and the must take all three factors into account. future payment years, we proposed to removal of URR as a measure of dialysis Commenters also encouraged us to remove the URR Hemodialysis adequacy, stating that the measure is adopt measures in all of these areas. Adequacy measure. In its place, we more accurate and used more widely by Response: We thank those proposed to adopt three measures of the dialysis community. Other commenters who advocated the dialysis adequacy (together comprising commenters, however, stated that URR monitoring of PTH. We recognize the one dialysis adequacy measure topic) is a more appropriate measure of important role played by parathyroid based on Kt/V (K = clearance, t = dialysis adequacy because Kt/V is hormone in mineral metabolism in the dialysis time, and V = volume of dependent upon many factors, ESRD population, and will pursue distribution) for the PY 2015 ESRD QIP including mid-week sampling, accurate avenues by which we may monitor and future payment years of the urine collection, and dialysis

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prescriptions, whereas URR needs only of seasonality. Additionally, utilizing Comment: Commenter stated that pre- and post-blood draws. One this timeframe will enable us to post the spKt/V does not reflect patients on short commenter did not support a Kt/V numerical values of the performance daily, frequent, and nocturnal dialysis measure because it only promotes standards as soon as they are available and should be updated accordingly. ‘‘adequacy’’ rather than optimal health, in December 2012 or January 2013. Another commenter requested that we urea is not associated with toxicity, it We thank the commenter for the develop a spKt/V measure for home does not take into account suggestion of collecting raw data rather dialyzers. ultrafiltration, and it is only a point in than calculated spKt/V values. At this Response: We are currently working time measurement. Some commenters time, we are not operationally able to with stakeholders to develop adequacy supported the adoption of Kt/V as a request these elements on claims. We measures to address other members of measure of dialysis adequacy for will consider this suggestion in future the ESRD population (i.e. frequent, hemodialysis patients, but requested years of the program. home, and nocturnal hemodialysis that we delay implementation until PY Comment: Several commenters patients) for future years of the ESRD 2016 so that we can ensure the data we supported the measure but requested QIP. are using to calculate achievement that we refine it to specify that the Comment: One commenter requested thresholds, benchmarks, and calculated spKt/V include estimates of that we specify that the lab draw for this performance standards were calculated residual renal function (RRF) to avoid measure should be done mid-week to using consistent methodology. One incentivizing improper, longer dialysis better reflect patients’ actual conditions. Response: Under the measure commenter suggested that we include sessions for these patients; one specifications for the Kt/V adult Kt/V in PY 2015, but calculate rates for commenter recommended that, hemodialysis adequacy measure, performance standards, benchmarks, consistent with KDOQI guidance, RRF facilities are required to report the last and thresholds based on data from be included in spKt/V only if the urine spKt/V measurement of the month. The January 1, 2012–June 30, 2012 since collection used to measure it was within NQF-endorsed measures for minimum these dates would include only data that the previous 90 days. Commenters also dialysis adequacy for both pediatric and were calculated using the NQF- requested that we exclude patients adult patients do not adjust for the day endorsed formulae. Finally, one dialyzing four or more times per week of the week; a minimum target value of commenter stated that we should or overnight and include patients with spKt/V greater than or equal to 1.2 request raw data from facilities and Kt/V less than 2.5 since many patients should be achieved regardless of when calculate Kt/V to ensure consistency. achieve these values. Response: We thank those this is measured. We appreciate your Response: Consistent with the 2006 commenters who supported the suggestion and will take it under KDOQI Clinical Guidelines for implementation of these measures. We consideration during our ongoing hemodialysis adequacy, we do not find note that the published literature measure maintenance. published, medical evidence to support suggests there is insufficient evidence to Comment: One commenter stated that the inclusion of RRF in defining the support the superiority of alternative ‘‘dialysis adequacy’’ is a misnomer minimum target spKt/V. Additionally, measures of small solute clearance over because it does not provide a full effective January 2012, the Medicare spKt/V. The KDOQI Clinical Practice picture of dialysis adequacy. Instead, Guideline for Methods for Measuring claims processing instructions the commenter suggests it be called a and Expressing Hemodialysis Dose (CPG specifically state that the reported spKt/ measure of ‘‘urea removal,’’ encouraging 2) also state that ‘‘the delivered Kt/V V should not include RRF. We currently stakeholders to develop measures that determined by single-pool urea kinetic exclude patients dialyzing four or more are more comprehensive of dialysis modeling continues to be preferred as times per week from the adult HD adequacy. Another commenter asked us the most precise and accurate measure measure because this exclusion was to recognize that ‘‘adequacy’’ is not of dialysis’’ (page 12, KDOQI 2006 NQF-endorsed. synonymous with optimal levels. Update). Furthermore, the minimum According to the measure Response: ‘‘Dialysis adequacy’’ is delivered hemodialysis dose for both specifications, overnight dialysis used in the ESRD QIP to represent the adult and pediatric patients, spKt/ patients are included in the HD spKt/V quantification of urea removal by V>=1.2, was endorsed by NQF in 2007. measure unless they are dialyzing less dialysis, one widely accepted Regarding concerns about the use of than two or greater than four times per measurement of adequacy of this consistent methodology in the week, or if they are in the first 90 days treatment. We recognize there are other calculation of performance standards, of ESRD treatment. We do not currently aspects of dialysis adequacy, and we are beginning in January 2012, the measure have the ability to identify patients who currently working with stakeholders to specifications for adult and pediatric are receiving thrice weekly in-center develop additional measures for future hemodialysis Kt/V state that single-pool nocturnal hemodialysis and do not have years of the ESRD QIP. Additionally, we Kt/V be measured using Daugirdas II or a measure specific to this population. emphasize that these minimum spKt/V Urea Kinetic Modeling. We anticipate We are currently working with target levels may not be optimal levels that these specifications will provide stakeholders to develop adequacy for all patients. Therefore we encourage valid and consistent spKt/V values. measures to address frequent, home, clinicians to consider targeting higher We thank the commenter for the and nocturnal hemodialysis patients for spKt/V targets on an individual patient suggestion of utilizing data from January future years of the ESRD QIP. basis as clinically indicated. 1, 2012–June 30, 2012 to set Finally, patients with spKt/V less achievement thresholds, benchmarks, than 0.5 or greater than 2.5 are excluded ii. Peritoneal Dialysis Adequacy and performance standards. We believe, from the Kt/V adult hemodialysis Comment: Many commenters however, that whenever possible, these dialysis adequacy measure. Patients supported the adoption of this measure values should be based on a full year of with HD spKt/V values greater than 2.5 and asked us to finalize the measure data since these data, although not are excluded from the measure along with the formula and necessarily calculated using the same calculation as these values are methodology for its calculation. One NQF-endorsed methodology, represent considered implausible for most commenter explicitly asked us to any changes that may occur as a result hemodialysis patients. finalize a methodology for obtaining

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dialysate, blood, and urine sampling. measure; and (ii) exclude patients in the PD Kt/V values will be used in the Other commenters, however, did not first month they are eligible to be calculation. In response to the monthly support the measure, stating that we included in the denominator if no Kt/V measurement period comment, for PD have not yet specified a consistent measurement is taken until the fourth patients, facilities are only required to reporting methodology. These month since the measure specifies Kt/V report Kt/V once every 4 months. commenters suggested that we finalize need only be measured once every 4 Comment: One commenter urged us this measure as a reporting measure months. One commenter noted that a to develop a pediatric peritoneal only for PY 2015, define a methodology monthly measurement period for the dialysis adequacy measure in for calculating the values in the final measure is problematic because Kt/V is collaboration with stakeholders. rule, and use data from CY 2013 for assessed throughout the month in home Response: We are currently working purposes of adopting this measure as a training clinics; this commenter with stakeholders to develop a pediatric clinical measure in future years. One suggested that there be a 30-day window peritoneal dialysis adequacy measure as commenter stated that we should from the time of the adequacy measure part of a consensus-based measure request raw data from facilities and to adjust the prescription and repeat the development process, and we will calculate Kt/V to ensure consistency. adequacy measure. consider implementing such a measure through future rulemaking. Finally, some commenters stated that Response: We thank commenters for they did not support the measure. their feedback regarding the exclusion iii. Pediatric In-Center Hemodialysis Response: We thank the commenters criteria for Kt/V for adult peritoneal Adequacy who supported the adoption of this ESRD patients. To the first point, measure. There is more than one Comment: Several commenters patients are excluded from this measure method that may be used by facilities to supported the adoption of a Kt/V if they are in the first 90 days of calculate PD Kt/V. Methods for hemodialysis adequacy measure for treatment for ESRD. If a patient changes reporting PD Kt/V on Medicare claims pediatric patients even if we do not from hemodialysis to peritoneal dialysis were specified prior to the start of data adopt the adult Kt/V measures. Other during a month, the patient would be collection in July 2010 and are based on commenters, however, argued that we included in both the HD and PD Kt/V measure specifications endorsed by the should not finalize the pediatric in- measure calculations. The 2006 KDOQI National Quality Forum in 2007. center hemodialysis adequacy measure Clinical Practice Guidelines for Measurement of peritoneal dialysis Kt/ because (i) the measure does not peritoneal dialysis adequacy (Guideline V is based on timed (24 hour) dialysate exclude RRF patients; and (ii) the collection to measure urea clearance (k). 2.1.2) state ‘‘the total solute clearance measure applies to 4 times per week Time (t) is specified in the definition (residual kidney and peritoneal, in hemodialysis. These commenters (week or per week). The only terms of Kt/V) should be measured believe that adoption of the proposed component of Kt/V measurement in within the first month after initiating measure would, in effect, raise the peritoneal dialysis that is formula-based dialysis therapy and at least once every pediatric dialysis dose above the adult is the estimation of total body water (V). 4 months thereafter.’’ While this dialysis dose in a substantial number of V is estimated from either of two measure is consistent with the children who either have a significant formulae (Watson or Hume) predictive guideline, we acknowledge that a RRF or are treated with dialysis four equations that are based on patient patient may be included in the PD Kt/ days a week; they caution that we anthropometric and demographic V measure calculation in the same should avoid incentivizing improper, information. We will consider the month their modality changed to PD. longer dialysis sessions for these standardization of estimating total body However, after switching from patients. Some commenters urged us to water as part of our annual ongoing hemodialysis to peritoneal dialysis, harmonize the adult and pediatric spKt/ measure maintenance process, but we peritoneal dialysis clearance typically is V hemodialysis adequacy measures, note that we believe it is appropriate to not measured right away or even in the specifically regarding the required adopt this measure without this same month as the PD catheter number of dialysis sessions for standardization because the Watson and insertion, as the peritoneal membrane is inclusion in the measure and the Hume formulae yield substantially in a state of flux and its membrane inclusion of RRF. Another commenter similar results. Moreover, NQF transport characteristics are unstable for stated that we should consider changing approved the measure with the a few weeks. In several clinical the measure so that it is based on specification to use the Watson or Hume scenarios it may not be appropriate to weekly dose. Other commenters stated, formula to estimate ‘‘V.’’ We choose to measure PD Kt/V within the first several generally, that spKt/V is not appropriate collect reported Kt/V, rather than the weeks after initiation of peritoneal for pediatric patients and encouraged us data elements for Kt/V, due to the dialysis. Therefore, we believe that the to work with stakeholders to develop a limitations of collecting data on PD unit personnel will not have suitable pediatric dialysis measure. Medicare claims and to minimize measured PD adequacy in the 30 days Response: We thank the commenters burden on facilities. following the transition from HD to PD. who supported the implementation of Comment: One commenter supported With regard to the comment on the spKt/V hemodialysis adequacy the use of Kt/V as a measure of dialysis excluding patients from the measure for pediatric patients and those adequacy for peritoneal dialysis denominator for the first month if no who provided feedback for its patients, but suggested that we refine it measurement is taken until the fourth implementation. The measure in the final rule. This commenter stated month, we use the data reported in methodology was developed through a that we need to: (i) Clarify in the conjunction with Medicare dialysis consensus-based process incorporating technical measure specifications that a facility claims value code D5: Result of the input of a Technical Expert Panel patient is only included in the measure last Kt/V reading and occurrence code and was endorsed by NQF in 2011. The population if he/she has been on 51: Date of last Kt/V reading. The claims pediatric hemodialysis adequacy peritoneal dialysis for 90 days or more reporting instructions indicate that for measure differs from the corresponding so that a patient transferring from PD patients this should be within the adult adequacy measure in that the hemodialysis to peritoneal dialysis will last 4 months of the claim date of measure applies to patients receiving not be immediately counted in the service. All monthly claims with valid four dialysis treatments a week.

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Analysis of 2007 claims data suggest http://www.dialysisreports.org/pdf/esrd/ calculated using the rates from that in 5.6 percent of patient-weeks, public-measures/ November and December of the dialysis sessions occurred four times per PediatricHemodialysisAdequacy-ktv- previous year as well as January of that week for pediatric patients. Given that 2015–FR.pdf (pediatric in-center year. Likewise, we proposed that the this is a significant proportion, the TEP hemodialysis). rate for February would be calculated concluded that these patients should be using the rates from December, January b. Hypercalcemia included in this measure. As seen in and February to calculate the 3-month Table 4 below, there were three or four Section 1881(h)(2)(A)(iii) of the Act rolling average, and so on. Technical dialysis sessions in approximately 88 states that the measures specified for the specifications for this measure can be percent of patient-weeks. Based on these ESRD QIP shall include other measures found at http://www.dialysisreports.org/ results, the TEP concluded that by as the Secretary specifies, including, to pdf/esrd/public-measures/ defining the denominator as the extent feasible, measures of bone MineralMetabolism-Hypercalcemia- hemodialysis patients receiving dialysis mineral metabolism. Abnormalities of 2015–NPRM.pdf. three or four times weekly, the measure bone mineral metabolism are The comments we received on these will be applicable to most pediatric exceedingly common and contribute proposals and our responses are set hemodialysis patients. significantly to morbidity and mortality forth below. in patients with advanced Chronic Comment: Several commenters TABLE 4—DIALYSIS SESSIONS PER PA- Kidney Disease (CKD). Numerous supported this measure, noting that it is TIENT WEEK AMONG ALL HD PEDI- studies have associated disorders of consistent with KDIGO guidelines and ATRIC PATIENTS < 20 YEARS OLD mineral metabolism with morbidity, is especially necessary given that we including fractures, cardiovascular will include oral-only drugs in the Sessions Number of disease, and mortality. Therefore, we bundle beginning in PY 2014; some per week patient-weeks Percent believe it is necessary to adopt a clinical commenters specifically argued that that measure that encourages proper bone there is sufficient validity and reliability 1 ...... 211 2.6 mineral metabolism management. of the data collected in CROWNWeb to 2 ...... 614 7.5 One indicator of bone mineral establish an appropriate clinical 3 ...... 6712 82.2 metabolism management is ensuring 4 ...... 533 6.5 measure for PY 2015, and noted that 5 ...... 60 0.7 normal calcium levels in the blood. this measure is in keeping with 6 ...... 36 0.4 Therefore, we proposed to use the NQF- Congress’ intent to include a measure of 7 ...... 3 0.04 endorsed measure, NQF #1454: bone mineral metabolism in the ESRD Proportion of patients with QIP. Other commenters, however, stated N=312 patients with first Medicare hypercalcemia, to evaluate ESRD their belief that, despite its NQF- dialysis claim on or before January 1, facilities for the PY 2015 and future endorsement, the measure is not aligned 2007. payment years of the ESRD QIP. This with clinical standards, is contrary to With regard to the incorporation of measure assesses the number of patients KDIGO guidelines, and does not RRF in the calculation of adequacy, the with uncorrected serum calcium greater advance the aims of the National TEP did not agree that RRF should be than 10.2 mg/dL for a 3-month rolling Quality Strategy. Additionally, several added to the measure description for average. ‘‘Uncorrected’’ means not commenters, both those supporting and several reasons: (i) Published studies corrected for serum albumin opposing the measure, argued that it is evaluating dialysis adequacy in the concentration. Performance on this inappropriate to use CROWNWeb data pediatric population do not include measure is expressed as a proportion of to define performance standards, residual renal function; (ii) RRF changes patient-months for which the 3-month achievement thresholds, and continuously with age in the pediatric rolling average exceeds the measure benchmarks because the data population; and (iii) RRF is difficult to threshold. Because the NQF-endorsed underrepresents small- and mid-sized measure among pediatric patients. measure calls for a 3-month rolling dialysis organizations, does not account Neither the NQF-endorsed measure average, we also proposed that the first for the differences in reporting which specifications nor the KDOQI guidelines measure rate for this measure would be may exist when data are voluntarily support measuring spKt/V in pediatric calculated using the first 3 months of reported (and data were voluntarily patients based on a weekly dose. data collected during the proposed reported in the CROWNWeb pilot), was Furthermore there is no evidence to performance period (that is, there would submitted with the understanding that it support a minimum target value for a be no measure rate for the first 2 months was test data and would not be used by weekly Kt/V dose. We will continue to of the performance period; we would CMS programs, and because it suffers consider other measurements of dialysis calculate the first measure rate for the from serious data collection problems, a adequacy for the pediatric population; performance period using the first 3 lack of definitions, and a lack of at this time, we believe that this months of data and would then reporting requirements in CROWNWeb. measure is the most suitable. calculate a rate each successive month, Many commenters suggested that we For the reasons stated above, we are dropping the oldest month and adding adopt this measure as a reporting adopting the Kt/V measure topic as the newest month). Because we measure only for PY 2015. Several other proposed. The technical specifications proposed to adopt this measure not only commenters believe that the proposed for each of the finalized measures in this for PY 2015, but also subsequent hypercalcemia measure is only measure topic can be found at http:// payment years, we also proposed that, appropriate if we include similar www.dialysisreports.org/pdf/esrd/ beginning with the PY 2016 program, clinical measures for serum phosphorus, public-measures/ we would measure hypercalcemia parathyroid hormone (PTH), and other HemodialysisAdequacy-ktv-2015– beginning in January of the applicable mineral metrics because a FR.pdf (adult hemodialysis), http:// performance period. This would allow hypercalcemia measure alone represents www.dialysisreports.org/pdf/esrd/ us to have a 3-month rolling average for a piecemeal approach to bone and public-measures/ all months in the performance period. mineral metabolism that will not be PeritonealDialysisAdequacy-ktv-2015– We proposed that the 3-month rolling sufficient to ensure quality care for FR.pdf (adult peritoneal dialysis), and average rate for January would be ESRD patients and may even incentivize

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inappropriate care. Finally, commenters future rulemaking, when the claim is returned to the facility (CR recommended that CMS monitor Hypercalcemia measure is considered as 7593). If a hemoglobin or hematocrit secondary parathyroid hormone and not a measure for the ESRD QIP in future value is not available for a patient, a include oral-only drugs in the bundle payment years. facility can enter a default value of until such measures and monitoring are For the reasons discussed above, we 99.99 on the claim and the claim will in place. will not finalize the Hypercalcemia not be returned, provided the facility is Response: Commenters rightly state measure for use in the PY 2015 ESRD not billing for an ESA. The default value that the performance standards, QIP or subsequent years until indicated is not acceptable when the claim achievement thresholds, and otherwise in rulemaking. includes an ESA, in such a case, the benchmarks for the proposed claim will be returned to the facility. Hypercalcemia measure were not c. Anemia Management Reporting We stated in the proposed rule that calculated using data from all facilities. Measure we are concerned that our current Because it is possible that these Section 1881(h)(2)(A)(i) requires policy of paying claims that include a calculations could contain a systemic ‘‘measures on anemia management that default hemoglobin or hematocrit value bias, and we have no effective means of reflect the labeling approved by the of 99.99 could lead to the under- addressing that bias in the ESRD QIP as Food and Drug Administration (FDA) reporting of patients’ hemoglobin or this time, we will not finalize a clinical for such management.’’ Although the hematocrit levels and ESA dosage by measure for hypercalcemia, as discussed current FDA-approved label for ESAs facilities; we are specifically concerned above, until valid data from all facilities only specifically addresses hemoglobin that we will not receive complete and are accessible for the purpose of levels greater than 11 g/dL, previous accurate hemoglobin/hematocrit establishing performance standards, FDA-approved labels suggested patients readings for those patients not receiving achievement thresholds, and on ESAs maintain a hemoglobin level of ESAs because a default value of 99.99 benchmarks. We are not finalizing a 10–12 g/dL. As we noted in the CY 2012 can be reported on claims, and these clinical Hypercalcemia measure at this ESRD PPS final rule, upon further claims will be paid, if no ESA is time. We do, however, continue to research, the FDA determined that there administered to the patient. believe that hypercalcemia is an is no evidence suggesting a lower target Additionally, we believe that facilities important indicator of bone mineral level at which hemoglobin does not might choose to strategically not report metabolism, and we intend to use this cause increased risks of death, serious certain patients’ hemoglobin or measure in subsequent payment years. adverse cardiovascular reactions, and hematocrit levels on certain claims— Comment: One commenter stated that, stroke and, therefore, changed its those where the patient’s hemoglobin generally, we should not use data from approved label on June 24, 2011 (76 FR levels are greater than 12 g/dL—in order CROWNWeb for the ESRD QIP until the 70257). to make the performance rate of their validity of CROWNWeb data is As a result of the changes in the FDA Hemoglobin Greater Than 12 g/dL confirmed. Commenters also urged us to approved-label and the implementation measure seem better and reduce the find solutions for the CROWNWeb of the ESRD QIP, we are monitoring likelihood of a payment reduction under issues which the community has been trends and indicators of anemia the ESRD QIP. experiencing in order to ensure that, as management for the Medicare ESRD Because it is possible that facilities measures increasingly rely on population. We have found that the could under-report hemoglobin or CROWNWeb data, there is no question average monthly blood transfusion rate hematocrit levels, we proposed to adopt as to the data’s validity. increased from 2.7 percent in 2010 to an Anemia Management reporting Response: We thank the commenters 3.2 percent in 2011. We are working measure for the PY 2015 ESRD QIP, and who expressed concern regarding the through our ESRD QIP monitoring and future payment years of the program. use of CROWNWeb data for the ESRD evaluation program to further assess the For this measure, we proposed to QIP. Given the potential risk to validity effect of the ESRD PPS. We believe that require facilities to report a hemoglobin of ESRD QIP clinical measures it is important that we continue or hematocrit value and, as applicable, calculated using CROWNWeb data, we monitoring hemoglobin levels in an ESA dosage for all Medicare patients will not finalize the proposed clinical patients to ensure that anemia is at least once per month via claims. We measure for hypercalcemia that depends properly treated, and we, therefore, proposed to consider claims with 99.99 on those data, as noted above. proposed to adopt a measure for PY values as not meeting the requirements Comment: One commenter urged us 2015, and future payment years, which of this measure (that is, claims reporting to exclude patients who have requires facilities to report ESA dosage 99.99 will be counted as if the hypercalcemia for reasons other than (if applicable) and hemoglobin and/or hemoglobin or hematocrit value were ESRD treatment (for example, hematocrit levels for patients on at least left blank). medication and malignancy) from the one monthly claim. In addition to this We stated that we do not intend for this proposed measure to encourage Hypercalcemia measure. The measure, proposed below, we plan to unnecessary testing or unduly burden a commenter requests confirmation that continue to monitor the rate of facility. Consequently, for purposes of the Hypercalcemia measure includes all transfusions and may consider the scoring the measure, we considered patients rather than just Medicare adoption of relevant quality measures proposing to require facilities to report patients, and is concerned with CMS’ through future rulemaking if necessary. move to include the total facility Since January 1, 2012, facilities have the required information for less than population in the measure collection been required to report hemoglobin or 100 percent of their patients. Specifically, we considered lowering process. One commenter seeks hematocrit 4 levels for each patient on the threshold to reporting 98 percent of clarification regarding whether a lower every claim (CR 7640). Beginning April patients for a month in order to receive or higher rate is desirable for the 1, 2012, if a hemoglobin or hematocrit credit for that month. We ultimately Hypercalcemia measure. value is not included in the claim, the Response: We thank the commenters proposed that a facility should be for raising these issues with the 4 Hematocrit values are used to calculate required to take and report these values Hypercalcemia measure, and we will hemoglobin levels by taking the hematocrit value for every patient at least once per month incorporate them in discussions during and dividing by three. so that each beneficiary receives the

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highest standard of care. We realize, changes in transfusion rates with the dialysis patients; (iii) pediatric patients however, that there are circumstances ESRD PPS, FDA labeling changes, and (unless the measure is specific to this beyond a facility’s control wherein it other factors are not yet known, we population); and (iv) kidney transplant may not be able to draw a sample for believe proactive facility engagement in recipients with a functioning graft. this patient. Therefore, we did not regular monitoring of patient Commenters stated that these exclusions propose that the facility itself must draw hemoglobin or hematocrit levels would be consistent with our own blood for each patient. If, for example, regardless of ESA use is critical to measures reported on DFC; commenters a patient is hospitalized or transient maintaining safe care, protecting the also stated that these exclusions seek to during a claim month, the facility may safety of beneficiaries, and monitoring hold facilities accountable only for report the hemoglobin/hematocrit the program effectively. We further those beneficiaries to whom they readings and ESA dosage (if applicable) believe that the data collected from the regularly give care and for whose care for the patient for a month if a patient proposed measure are necessary for they can affect. Another commenter, has labs drawn by another provider/ measure development in a clinical area however, stated that we should not facility and those labs are evaluated by of critical significance to patient implement other commenters’ an accredited laboratory (a laboratories safety—anemia and transfusion. A delay suggestions that we exclude that is accredited by, for example, the in proposing to adopt this reporting beneficiaries receiving home dialysis Joint Commission, the College of measure may prevent us from creating therapy who miss their in-center American Pathologists, the AAB clinical measures for use in future years appointments when there is a (American Association of Bioanalysts), of the program and pose a risk to documented, good faith effort to have or State or Federal agency), and the patients. Finally, we noted that section them participate in such a visit during dialysis facility obtains the hemoglobin/ 1881(h) of the Act specifically the applicable month; this commenter hematocrit readings and ESA dosage. highlights the importance of anemia stated that it is the responsibility of the Additionally, we proposed to only management measures, and we do not facilities to educate patients on the consider a patient qualified for this believe it would be in the best interest importance of making and keeping measure (i) if the patient is alive at the of the program to wait an additional appointments. Additionally this end of the month; (ii) if the patient is year to propose this measure. commenter argued that ‘‘good faith’’ is treated in-center, that patient was For the reasons stated above, we too vague; commenter requested that, if treated at that facility at least twice proposed to adopt an Anemia we did adopt this exclusion, we clearly during the claim month; and (iii) if the Management reporting measure for the define a ‘‘good faith effort.’’ Another patient receives dialysis at home, a PY 2015 ESRD QIP and subsequent commenter stated that peritoneal claim is submitted for that patient. We payment years. We provided the dialysis patients do not need to be seen believe that these proposals will provide technical specifications for this at a facility once per month and the more flexibility for facilities and will measure, at http:// measure should be accordingly revised. also discourage facilities from drawing www.dialysisreports.org/pdf/esrd/ public-measures/AnemiaManagement- Response: Consistent with the blood, even when not necessary for fear Mineral Metabolism reporting measure, that the patient will fail to come to the Reporting-2015–NPRM.pdf. We requested public comment on these we agree with commenters who believe facility again during that month. We that the exclusions should be modified. requested comment on this proposal. proposals. The comments we received on these We recognize that treating a patient We also requested comment on whether proposals and our responses are set twice may not provide enough time to facilities should only have to report data forth below. effectuate quality patient care. We agree for 98 percent of their patients. Comment: Some commenters with the commenters who suggested The proposed Anemia Management supported the measure, stating that they that an in-center hemodialysis patient reporting measure was not included in believe this measure will allow us to should be excluded if treated by a the list of measures under consideration closely monitor the underutilization of facility fewer than seven times during in accordance with section 1890A(a)(2) ESAs and the increase in transfusions. the month, regardless of whether the of the Act because we had not yet fully Commenters also stated that they patient is officially admitted to that assessed the impact of the new FDA- believe that this measure will assist in facility. With seven treatments, we approved ESA labeling on the ESRD explaining and monitoring timely ESA believe that a facility should have had population. We have since received and discontinuation and studying the adequate opportunities to draw blood analyzed more, but still incomplete, potential effect of altitude on patients. necessary to report hemoglobin/ anemia management data; we believe it Many commenters supported this hematocrit. We also believe that the is necessary to require facilities to measure, but requested that we make threshold of seven will discourage provide complete data so that we may modifications to our proposed unnecessary testing of in-center fully understand the effect of the exclusions. These commenters hemodialysis patients by facilities changes to ESA labeling and other suggested that we exclude, for all of the because they will know that, since in- factors. The proposed Anemia reporting measures, the following center patients are typically treated Management reporting measure will patients: (i) Beneficiaries who are three times per week, a patient must play a critical role in patient safety. As regularly treated at the facility and who have been treated by the facility for at noted above, our monitoring activities fit into one of these categories: (a) least two weeks to be included; thus, the indicate that there has been a slight but beneficiaries who die within the facility need not feel pressure to draw noticeable increase in transfusions since applicable month; (b) beneficiaries that blood for every patient during the first the adoption of the ESRD PPS. receive fewer than 7 treatments in a few visits of the month. Based on these Additionally, a United States Renal Data month; and (c) beneficiaries receiving considerations, we will not finalize our System analysis presented in May 2012 home dialysis therapy who miss their proposal to only exclude in-center found an increase in blood transfusion in-center appointments when there is a patients who have been treated fewer rates among ESRD patients concurrent documented, good faith effort to have than two times by the facility during the with the implementation of the ESRD them participate in such a visit during claim month. Instead, we will exclude PPS. Although the association of the applicable month; (ii) transient any patient who is treated by the facility

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fewer than seven times during the that small facilities are not percent for each month of the reporting month. disproportionally affected. Another performance period, they will meet the We do not believe that it is necessary commenter stated that requiring 98 requirements of the measure. We believe to specifically exclude transient patients percent reporting may make it difficult that this methodology fairly balances from this measure because, as noted, for patients to travel because dialysis the concerns that the reporting in any patient that is treated by the facility facilities may encourage them otherwise CROWNWeb is skewed with our desire at least seven times during the in order to ensure compliance with the to encourage continued excellence in applicable reporting month is present at measure. One commenter requested that the community. the facility for enough time that the we provide guidance regarding the We are concerned that small facilities facility should be able to measure that standardization of blood-draws so that may be disproportionately impacted by patient’s hemoglobin/hematocrit. data can be reliable before we the reporting threshold because, for Likewise, for the same reasons, we do implement a reporting threshold. example, a facility with 10 patients not believe we need to separately Response: We agree with the could fail to report for only one patient exclude patients who are deceased at commenters who argued that, even with and, therefore, fail to meet the the end of the reporting month. exclusions, there are circumstances in threshold. As we discuss below, we Provided that the patient was treated by which facilities cannot report the believe that 11 cases is an appropriate the facility at least seven times during hemoglobin/hematocrit and ESA minimum for purposes of scoring that month, the facility should be able dosage, as applicable, for every patient clinical measures. As we have stated, to draw blood necessary to obtain at least once per month. It is possible we intend to use the information hemoglobin/hematocrit values even if that these exclusions alone may hold a collected from reporting measures for the patient is deceased at the end of the facility responsible for a patient who purposes of scoring clinical measures month. was technically treated by the facility based on the same data in subsequent Additionally, we do not agree that but who did not receive actual treatment payment years. Therefore, we will not facilities should not be held accountable from the facility during the applicable require a facility to report this measure for drawing blood from home dialysis month. For example, a facility may wait if it treats less than 11 (i) in-center patients who fail to attend a monthly to draw blood from a patient because it Medicare patients who have been appointment. We believe that it is believes that the patient will be treated treated at least seven times by the incumbent upon a facility to make home there for the entirety of the month, but facility; or (ii) home hemodialysis dialysis patients aware that they must learns that the patient has been Medicare patients for whom the facility attend monthly appointments to be hospitalized unexpectedly for all or part submits a claim. If a facility does not properly treated. Therefore, we will of the applicable month. Therefore, we treat at least 11 of these patients during finalize our proposal that we will believe that we should not require the performance period, it will be include any home hemodialysis patient facilities to report for 100 percent of required to attest to this fact via for which a facility submits a claim with their patients. Based on data from CROWNWeb. If a facility does not make respect to the reporting month in this CROWNWeb, we believe that facilities the attestation, we will score it measure. report hemoglobin/hematocrit and ESA accordingly. Finally, we believe it is important to dosage for approximately 99 percent of Comment: Several commenters do not include transplant patients until they their patients on a monthly basis. We support this measure because facilities are officially discharged from a facility; believe it is appropriate to assume that already collect these data so the regular monitoring can help ensure that a similar percentage was reported via measure is unlikely to improve care. a transplant remains effective and the claims. Although, as commenters have Some of these commenters asked us to facility is continuing to provide the best argued with regard to the Mineral require facilities to report this care possible. Metabolism reporting and the information separate from the ESRD QIP For the reasons stated above, we will Hypercalcemia measures, this on at least one monthly claim to ensure modify our proposals for the exclusions information in CROWNWeb was anemia is properly treated. for this measure and finalize that, for voluntarily reported which may mean Response: As we noted in the the PY 2015 ESRD QIP, facilities must that the data is biased toward facilities proposed rule (77 FR 40974), we believe report hemoglobin/hematocrit at least that value reporting; additionally, the that this measure will discourage once per month via claims for (i) in- data from the CROWNWeb pilot was underreporting of ESAs and center Medicare patients who have been mainly supplied by LDOs that may be hemoglobin. Currently, facilities may treated at least seven times by the more likely to have more resources and report a value of 99.99 as default facility; and (ii) home hemodialysis corporate policies that require reporting hemoglobin for claims that do not Medicare patients for whom the facility compliance. include an ESA. Since the bundle submits a claim. If the facility Taking all of these issues into includes ESAs, it may not be financially administers an ESA to these patients, it consideration, we finalize a normative beneficial for a facility to report an ESA, must also report the HCPCS code and reporting threshold for this measure; especially if a patient’s hemoglobin is corresponding unit for that patient. We facilities will be required to report at the greater than 12—negatively affecting its will interpret an empty HCPCS field to lesser of the 50th percentile of all Hemoglobin Greater than 12 g/dL mean that no ESA was administered. facilities in 2013 or 99 percent, in total, measure score. Additionally, we are Comment: Several commenters of their (i) in-center Medicare patients concerned that the 99.99 value will be encouraged us to not adopt a percentage who have been treated at least seven overutilized and will not allow us to reporting threshold because it does not times by the facility; and (ii) home properly monitor hemoglobin levels distinguish between beneficiaries hemodialysis Medicare patients for across the ESRD population. If we are legitimately excluded and those that whom the facility submits a claim. This able to closely and accurately monitor were merely missed. Other commenters floor ensures that facilities are not ESA dosage and hemoglobin, we believe requested that we use both exclusions penalized as long as they report at a we will be able to improve care by using and a threshold; one commenter high rate that is consistent with this information to monitor the effects of suggested a threshold of 90 percent or CROWNWeb data; that is, facilities the bundle and the ESRD QIP on an allowance of two patients to ensure know that, provided they reach 99 beneficiaries; we also believe we may

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utilize these data in the future to Policy (2006) 5 requests that the and how we will account for patient develop an anemia management clinical hemoglobin/hematocrit reading reported weight in our analyses. measure. on claims be defined as ‘‘the most recent Response: We believe that the anemia management reporting measure Comment: Many commenters noted reading taken before the start of this emphasizes the importance of anemia that it is impractical for facilities to billing period. For patients beginning management for the ESRD population obtain lab values from other providers dialysis, use the most recent value prior to the onset of treatment.’’ We recognize and will support efforts to establish because other providers are not required that, for some patients, specifically more meaningful, evidence-based to measure these data, do not share data those new to dialysis, this hemoglobin/ clinical measures of anemia with dialysis facilities, and, even if hematocrit values may not be available. management in the future. We intend to facilities could obtain these data, they Therefore, we will not require a facility publicly report the anemia management could not be sure that the labs were to report a hemoglobin/hematocrit value reporting measure rates in the same consistent or reported under the same for a patient if that patient has been on manner that we use to publicly report standards. Additionally, one commenter dialysis for less than one month other measure rates under the ESRD QIP argued that hemoglobin levels from (including when dialysis is resumed but will not score facilities based on other facilities will be of little use after a transplant); facilities may report those rates. Facilities will be able to without further information regarding the default value without being preview the reporting data to be why the patient was at that facility. One penalized in this circumstance. We publicly reported before we post it on commenter agreed that hemoglobin/ remind facilities that if an ESA is DFC. At present, the Anemia hematocrit values can be supplied by reported on a claim, the facility must Management reporting measure does not another provider provided the labs are also report a hemoglobin/hematocrit take patient weight into account, but we evaluated by an accredited facility. level, regardless of whether that patient will consider whether this type of adjustment is appropriate for future Response: We recognize that it may be is new to dialysis (CR 7460). years of the ESRD QIP. We would also difficult for facilities to coordinate with Comment: One commenter asked us like to clarify that we will use HCPCS hospitals and other providers in order to to include Omontys, an ESA new to the market, in this measure. Other codes that indicate ESA administration obtain lab values. We, however, are not and their corresponding units for mandating facilities to do so. In the commenters generally requested that we monitor new ESAs and their effects on assessing whether an ESA was proposed rule (77 FR 40974), we stated administered. We will interpret an hemoglobin levels. that facilities may obtain lab values empty HCPCS field to mean that no ESA from other providers. This proposal was Response: We intend to monitor ESA was administered. specifically designed to afford facilities dosage for all ESAs used by dialysis Comment: One commenter supports more flexibility in acquiring and facilities. Using HCPCS codes, a facility this measure but suggests that the data reporting hemoglobin and hematocrit must indicate which ESA it be captured in CROWNWeb since values, as well as ESA dosage. Facilities administered, including Omontys. hemoglobin levels are only reported on are highly encouraged to coordinate Comment: One commenter noted that claims with ESA doses. with other providers, but this measure it supports the reporting of hemoglobin, Response: The commenter is correct does not mandate them to do so. We but not hematocrit because the data set that CROWNWeb only requires a believe that the commenters’ concerns should be standardized to require only hemoglobin/hematocrit if an ESA is about inconsistent lab data are mitigated hemoglobin reporting. entered. by the requirement that the lab must be Response: Facilities can report either Since January 1, 2012, however, accredited. Further, we do not believe hemoglobin or hematocrit on claims. facilities have been required to report that data from another provider will be Either will count for the purpose of this hemoglobin/hematocrit on claims of little use. We can use these values to measure. (For the Hemoglobin Greater regardless of whether an ESA dose was administered (CR 7460). Facilities are monitor hemoglobin and hematocrit than 12 g/dL measure, hematocrit values are changed to hemoglobin by dividing expected to report the anemia levels of ESRD patients, as well as ESA by 3). As of 2011, only 14 percent of management reporting measure on their dosage; additionally, collecting these facilities reported hemoglobin, while 70 claims. data may encourage providers to engage percent reported hematocrit. We believe Comment: One commenter supports one another about the patient’s that requiring 70 percent of all facilities the measure but only for patients with conditions and care. to alter their reporting method would hemoglobin less than 10 g/dL. It is more Comment: One commenter noted that generate undue burden on the dialysis likely, the commenter argues, that one hemoglobin values on claims are from facility community, for relatively little will identify a patient with a low the prior month; therefore the 99.99 is gain, as we have an established method hemoglobin (even if that patient is not used for the claim in the first month of for incorporating both hemoglobin and on ESAs) if a new reporting measure is a patient’s dialysis or if a patient had a hematocrit into the measure calculation. instituted. The commenter believes that transplant. The commenter requested Comment: Some commenters asked us reporting hemoglobin for patients not on clarification on what it should report in to state the purposes of the anemia ESAs who have a hemoglobin greater these circumstances. Other commenters management reporting measure with than 12 g/dL is not necessary because argued that 99.99 should be available more specificity. Some commenters these patients are not at risk for the without penalty to facilities because in requested that we clarify how we intend complications that arise from targeting some instances, it is appropriate. One to report and make publicly available high hemoglobin levels using ESAs. commenter supported disincentivizing hemoglobin/hematocrit levels and ESA Response: It is our intention to use the 99.99 reporting in order to stop facilities dosages. Commenters asked us to clarify data we collect from this reporting from not reporting patients with high the plans for the use of the information measure to develop an anemia hemoglobin. management clinical measure and monitor anemia management trends. In Response: The commenter is correct 5 http://www.cms.gov/Outreach-and-Education/ Medicare-Learning-Network-MLN/ order to better understand the ESRD in that the Erythropoietin Monitoring MLNMattersArticles/downloads/MM4135.pdf. population as a whole and collect a

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robust data set, we believe it is a. Standardized Hospitalization Ratio received NQF-endorsement in 2011. The important to collect hemoglobin/ (SHR) data needed to calculate the SHR hematocrit levels for patients regardless Hospitalizations are an important measure have been regularly reported to of their values or if an ESA was indicator of patient quality of life and DFR since 1995 and have been used by administered. Using this information, morbidity. The SHR is an NQF-endorsed facilities for quality improvement activities. We plan to add the SHR data we can, among other things, assess (#1463), risk-adjusted measure of to the DFC effective January 2013; trends across the entire population and hospitalization for dialysis patients. The additionally we will report the actual use these data for measure development measure is claims-based and describes, SMR rates/ratio on the DFC beginning and monitoring purposes. as a ratio, the number of ESRD Medicare As explained above, we are modifying January 2013. patient actual admissions versus We originally proposed to adopt the our proposed exclusions and finalizing expected hospitalizations adjusted for that a facility must report hemoglobin/ SHR measure for the PY 2014 ESRD the facility’s Medicare patient case mix. QIP, but did not finalize the proposal, hematocrit and ESA dosage (via HCPCS Please refer to the NQF Web site codes and their units) for the lesser of in part, because commenters voiced (www.qualityforum.org) to obtain more concerns regarding the accuracy of the the 50th percentile of facilities in 2013 detail about this measure. or 99 percent, in total, of its (i) in-center co-morbidity data used in the calculation of the measures. Details on Medicare patients who have been b. Standardized Mortality Ratio (SMR) public comments and why we did not treated at least seven times by the The SMR measure is an NQF- adopt the SHR measure are articulated facility; and (ii) home hemodialysis endorsed (#0396) critical patient- in the CY 2012 ESRD PPS final rule (76 Medicare patients for whom the facility centered, outcome measure of overall FR 70267). Since that time, we have submits a claim. We will interpret an patient care furnished by facilities. We identified that the claim form UB 92 empty HCPCS field to mean that no ESA believe that the SMR measure would with the type of bill (TOB) field 72x was administered. We also finalize that encourage appropriate overall patient allows a facility to input up to 17 co- we will only apply this measure to care by facilities and incentivize morbid conditions per claim facilities with at least 11 (i) in-center facilities to examine the holistic health submission. We acknowledge that Medicare patients who have been of the patient rather than treating the patient co-morbidities can change with treated at least seven times by the patient based on an individual measure- time and since the capability already facility; and (ii) home hemodialysis by-measure basis. The SMR measure exists on the UB 92 TOB, we believe the Medicare patients for whom the facility describes, as a ratio, the number of best means for facilities to update submits a claim. Facilities who treat less ESRD Medicare patient actual deaths patient co-morbidities is through the than 11 of these patients during the versus expected deaths adjusted for the ESRD 72x claims form. Details on this performance period must attest to this facility’s Medicare patient case mix. form can be found in the Medicare fact in CROWNWeb. If they do not make Please refer to the NQF Web site Claims Processing Manual, Chapter 8— this attestation, we will score them (www.qualityforum.org) to obtain more Outpatient ESRD Hospital, Independent accordingly. Additionally, we will not detail about this measure. Facility, and Physician/Supplier Claims penalize facilities for using the default (https://www.cms.gov/manuals/ 99.99 value for a patient in his/her first c. Public Reporting of SHR and SMR Measures downloads/clm104c08.pdf). month of treatment at that facility. The In addition, because the NQF- technical specifications for this Although the SHR and SMR measures endorsed SHR and SMR measures are finalized measure can be found at may not be adopted for the ESRD QIP risk-adjusted for ESRD patients that http://www.dialysisreports.org/pdf/esrd/ until a future payment year, we intend reside in nursing homes, in order to public-measures/AnemiaManagement- to publicly report these measure ratios calculate the measure rates on DFC, we Reporting-2015-FR.pdf. to the public via Dialysis Facility will utilize data from the Minimum Data Compare (DFC) to encourage facilities to 4. Measures Under Consideration for Set (MDS) to identify those individuals improve their care. Section 4558(b) of Future PYs of the ESRD QIP in nursing homes. We would use these the Balanced Budget Act of 1997 (Pub. data not only for reporting the measure In addition to the PY 2015 ESRD QIP, L. 105–33) (BBA) directs the Secretary rates on DFC at present, but also for we noted in the proposed rule that we to develop, not later than January 1, calculating the measures if we adopted are considering measures for future 1999, and implement, not later than them for use in future years of the ESRD payment years of the program. We are January 1, 2000, a method to measure QIP. The Omnibus Budget specifically considering whether we data reflective of the quality of renal Reconciliation Act (OBRA) of 1987 should propose in future rulemaking to dialysis services provided under the requires that all Medicare and Medicaid adopt the following two measures, Medicare program. Under this authority, certified nursing homes complete MDS • NQF #1463: Standardized we began reporting the SMR measure on assessments on all of their patients. Hospitalization Ratio for Admissions DFC in January, 2001 as a survival We requested comment regarding the (SHR) and measure and used three categories to feasibility of adopting these measures • rate facility performance: ‘‘as expected,’’ for future payment years of the ESRD NQF #0369: Dialysis Facility Risk- ‘‘worse than expected,’’ and ‘‘better than adjusted Standardized Mortality Ratio QIP. expected.’’ The SMR measure that we The comments we received on these (SMR). are considering adopting for the ESRD proposals and our responses are set We stated that we intend to adopt these QIP was developed in 1999 and forth below. measures for future payment years of facilities are required to submit these Comment: Although most the ESRD QIP, possibly beginning with data via form 2746. The SHR measure commenters agreed that measures for the PY 2018 program. We notified that we are considering adopting for the hospitalization are important for quality facilities of our intent and solicited ESRD QIP was developed in 1995, reporting purposes, many commenters comments on incorporating these presented to a Technical Expert Panel strongly opposed that the SHR measure measures into future payment years of after modifications to risk adjustment be included in the ESRD QIP in the ESRD QIP. and statistical modeling in 2007, and subsequent payment years. These

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commenters argued that the SHR enough data on SHR to report rates on hospitalizations and other co- measure is a measure over which DFC. morbidities and calculate their SHR in facilities have little control because Response: We thank the commenters real-time. patients often follow the advice of their who supported the future consideration Response: We will consider this primary care physician or visit a of the SHR for implementation. We suggestion if we decide to propose to hospital without consulting the facility intend to begin public reporting of the adopt the SHR measure for the ESRD to receive treatments that could be SHR on DFC as of January 2013 to QIP in future rulemaking. furnished in the outpatient setting. indicate the relative performance of Comment: One commenter noted that Commenters expressed concern that the facilities. We believe that dialysis the SHR measure should be at least a measure could lead to cherry-picking, facilities own partial responsibility for two to three year measure as 1 year of disincentivize appropriate the rate at which their patients are data is not sufficient for an accurate hospitalization, and is not transparent hospitalized, in particular when that assessment. enough for facilities to make rate is substantially higher than at other Response: We recognize that the NQF- improvements in this area because of peer facilities and may not be explained specifications call for a measurement they are confused about the risk- by variation in the illness of patients. period that is longer than 1 year, and we adjustment methodology. Other We do acknowledge that care provided continue to assess how to implement commenters stated that the measure by dialysis facilities is not the sole such an extended measure period needs further refinement and validation, determinant of the hospitalization of effectively in the ESRD QIP if we specifically regarding risk adjustment ESRD patients and this measure would propose to adopt the SHR measure in for frail patients such as those in not support the assertion that they are. future rulemaking. nursing homes, cultural factors, The SHR is only shown for patients Comment: Many commenters opposed socioeconomic factors, and health with at least 5 patient years at risk, the use of SMR in future years for factors specific to the ESRD population. which corresponds to approximately 10 reasons similar to that of SHR. Commenters asked that these adjusters expected hospitalizations. The Commenters expressed concern that the be made public. One commenter confidence interval for the SHR will measure could lead to cherry-picking believes that this measure would create also be reported on DFC to show the and is not transparent enough for a bias for facilities on the basis of uncertainty in the value due to random facilities to make improvements in this location. Some commenters suggested variation, which will help to address the area because of they are confused about that, instead of implementing this issue of limited data for the SHR. We the risk-adjustment methodology. Other measure, CMS consider a coordinated appreciate these suggestions and will commenters stated that the measure care model. Other commenters take them into consideration as we needs further refinement and validation, requested that we adopt a pilot for this further assess the appropriateness of specifically regarding risk adjustment measure wherein only aggregate data is adopting the SHR measure for the ESRD for frail patients such as those in reported until the measure can be QIP. nursing homes, cultural factors, further assessed and validated. Several Comment: Some commenters strongly socioeconomic factors, and health commenters suggested that we support using the 72x claims as factors specific to the ESRD population. implement an SHR measure focused on indicators of risk factors for facilities Commenters asked that these adjusters admissions that could have been and patients. One commenter suggested be made public. One commenter prevented by interventions from dialysis that this information could be used in believes that this measure would create facilities; one commenter suggested that creating an access to care measure/ a bias for facilities on the basis of the SHR measure be modified to adjustment in the future. Other location. Another commenter argued calculate a ‘‘risk-adjusted standardized commenters, however, believe that that the measure should only account hospitalization ratio for dialysis access- reporting comorbidities on the 72x for catheter/dialysis complications and related infections and fluid overload,’’ claim could be a huge administrative should not include ‘‘sudden deaths.’’ since these are elements facilities can burden for facilities, including time One commenter stated that literature control. associated with validating that the data suggests that the measure is invalid in Response: We thank commenters for they submit on these claims is valid. small facilities and only valid in large these opinions. We will take these Response: We recognize that reporting facilities when averaged over several comments into consideration as we co-morbidities on 72x claims could be years. Some commenters suggested that, further assess the appropriateness of burdensome to some facilities. We instead of implementing this measure, adopting the SHR measure for the ESRD believe, however, that this information CMS consider a coordinated care model. QIP. is valuable, specifically in the context of Other commenters requested that we Comment: Many commenters strongly future measure development. We will adopt a pilot for this measure wherein supported the consideration of SHR for continue to assess the best means only aggregate data is reported until the future years of the ESRD QIP. One available for risk-adjustment for both measures can be further assessed and commenter requested that we the SHR and SMR measures, taking both validated. implement the measure as soon as the benefits of the information and the Response: We thank the commenters possible. Commenters also supported burden to facilities into account, should who shared concerns and provided reporting measure rates on DFC we propose to adopt these measures in suggestions regarding the future beginning in CY 2013. One commenter future rulemaking. consideration of the SMR for supports the addition of SHR data to Comment: One commenter argued implementation in the ESRD QIP. We DFC as long as a caveat is included that SHR is not a measure whereby will continue to consider these explaining that dialysis facilities can facilities can make meaningful suggestions as we decide whether to influence but do not control improvement because the measure’s propose to adopt the SMR measure. In hospitalization rates. This commenter rates cannot be calculated in real-time; the DFR, we limit reporting to facilities also requested that the ‘‘expected,’’ the commenter asked that claims be with at least 3 expected events for the ‘‘better than expected,’’ and ‘‘less than made available to the facility in a timely time period. Similarly, we only expected’’ categories remain on DFC. manner if the measure is adopted so that calculated SHR based on at least 5 One commenter argued that there is not they can become aware of patient years at risk, which corresponds

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to approximately 10 expected morbidities and may calculate their (iii) a measure for adequate serum hospitalizations. We incorporated these SMR in real-time. albumin; (iv) a measure promoting limitations on the measures to account Response: We will consider this immunizations; (v) measures assessing for potentially imprecise estimates suggestion if we decide to propose to iron management; (vi) patient fluid resulting from small facility size. adopt the SMR measure for the ESRD management measures; (vii) measures Comment: One commenter stated that QIP in future rulemaking. incentivizing home hemodialysis; (viii) the SMR measure should not be adopted Comment: One commenter noted that an NHSN measure for home patients until CMS can articulate how it fits into the SMR measure should be at least a that includes peritonitis; (ix) measures the ESRD QIP’s strategic vision. two to three year measure as 1 year is that specifically monitor nursing Response: While we recognize that not sufficient for an accurate sensitive indicators; (x) a measure that the ESRD population is at high risk for assessment. tracks which modalities a facility offers; mortality by definition, we believe that Response: We recognize that the NQF- (xi) a measure that tracks whether a mortality rates are susceptible to the specifications call for a measurement facility exceeds the average percentage quality of care provided by dialysis period that is longer than 1 year, and we of patients between 18 and 54 who are facilities. We believe the SMR may help continue to assess how to implement employed; (xii) a measure that tracks distinguish the quality of care offered by this measurement period effectively in whether facilities have shifts after 5:00 dialysis facilities as determined by the ESRD QIP if we decide to propose p.m.; (xiii) an emergency department mortality, a key health care outcome to adopt the SMR measure. use measure; (xiv) a measure on used to assess quality of care in other Comment: One commenter requested transplantations/referrals; (xv) a settings, such as hospitals. We believe clarification regarding whether the measure on dialysis adequacy for the SMR may also fill an important gap facility’s rates would be compared to frequent dialyzers; (xvi) measures on in the ESRD QIP by assessing the current or past national averages when phosphorus and PTH; (xvii) a composite outcome of all ESRD care provided at assessing the number of expected measure which takes into account the the dialysis facilities, rather than deaths. interdependability of calcium, Response: The SMR measure individual processes of care. For these phosphorus, and parathyroid hormone estimates the relative death rate ratio for reasons, we will continue to consider in bone mineral metabolism; (xviii) a facility, as compared to the national the inclusion of the SMR in future measures assessing quality of life; and death rate. The relative death rate ratio rulemaking cycles. (xix) palliative care measures. and the national results are all Comment: Many commenters strongly Response: We thank the commenters determined during the same (current) supported the consideration of SMR for for your comments regarding measure time period. implementation. We will take these future program years, noting that death In response to comments, we will suggestions into consideration during is the most important measurement of continue to consider the SMR and SHR future measure development and negative outcomes. One commenter measures for future years of the rulemaking. requested that we implement the program. We will, as proposed, begin measure as soon as possible. One displaying the rates/ratios for these Comment: Some commenters commenter suggested that the measure measures on DFC beginning in early specifically requested that we broaden specifically focus on patients within 2013. the use of pediatric measures in the their first 90–120 days of dialysis since ESRD QIP. These commenters these patients are generally more likely 5. Other Potential Future Measures recommended that we (i) develop (a) a to die. Commenters also supported Under Development dialysis adequacy measure for reporting measure rates on DFC As part of our effort to continuously peritoneal pediatric patients and (b) a beginning in CY 2013. improve the ESRD QIP, we are working CAHPS/experience of care measure for Response: We thank commenters for on developing additional, robust pediatric patients; and (ii) consider the their support of this measure. At this measures that provide valid assessments following NQF-endorsed measures: (a) time, we do not believe it should be of the quality of care furnished to ESRD Measure 1418: Frequency of Adequacy included in the PY 2015 ESRD QIP due patients by ESRD facilities. Some areas Measurement for Pediatric to the concerns voiced by other of measure development are discussed Hemodialysis Patients; (b) Measure commenters. We will consider the below. In addition, we are considering 1421: Method of Adequacy measure’s assessment of patients in the feasibility of developing quality Measurement for Pediatric their first months of dialysis for future measures in other areas such as kidney Hemodialysis Patients; (c) Measure rulemaking. Finally, we will begin transplantation, quality of life, health 1425: Measurement of nPCR for reporting the SMR measure rates on information technology for quality Pediatric Hemodialysis Patients; (d) DFC in 2013 and are attempting to improvement at the point of care and Measure 1433: Use of Iron Therapy for address potential shortcomings pointed the electronic exchange of information Pediatric Patients; and (e) 1424: out by commenters that we described in for care coordination, and transfusions. Monthly hemoglobin measurement for the CY 2012 ESRD PPS final rule (76 FR We requested comment on these Pediatric Patients. 70267) prior to proposing the measure potential areas of future measurement Response: We thank the commenters for ESRD QIP. and welcomed suggestions on other for suggesting additional measures Comment: One commenter argued topics for measure development. relevant to the pediatric portion of the that SMR is not a measure whereby The comments we received on these ESRD population for future facilities can make meaningful proposals and our responses are set consideration in the ESRD QIP. We improvement because the measure’s forth below. recognize the importance of assessing rates cannot be calculated in real-time; Comment: We received suggestions the quality of care furnished to pediatric the commenter asked that claims be for many future measures. These ESRD patients. To this end, we are made available to the facility in a timely included: (i) A CAHPS/experience of adopting in this final rule a measure of manner if the measure is adopted so that care measure for home dialysis and pre- pediatric hemodialysis adequacy for PY they can become aware of dialysis patients; (ii) a measure 2015. We will consider whether it is hospitalizations and other co- assessing catheter access site infections; appropriate to propose to adopt

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additional pediatric measures for the for the first year. One commenter stated Comment: In designing future years of ESRD QIP. that all future measures should be NQF- the ESRD QIP, commenters urged us to Comment: Some commenters endorsed before they are adopted. focus on the most important measures specifically discouraged us from Another commenter noted that NQF- because adding measures could dilute considering certain measures for future endorsement does not mean a measure each measure’s weight in the calculation ESRD QIP adoption. These included (i) is appropriate for the ESRD QIP. of the Total Performance Score. a quality of life measure, because no Response: We remain dedicated to a Response: We acknowledge the research shows that facilities can transparent, consensus-based measure commenter’s concern and note that we improve this aspect of patient life and development process that offers will seek to balance appropriateness of patients often refuse to take surveys; multiple opportunities for input from the measures, importance of the and (ii) measures on electronic stakeholders. The measure development measures, and parsimony as we information exchange because it is process that we currently use includes consider what measures to implement unclear what these measures would using Technical Expert Panels and through future rulemaking. entail or how they could be carried-out. public comment periods, seeking NQF Comment: Some commenters made Response: We appreciate the endorsement, providing measures to the broad suggestions about measure comments and will take them into Measures Application Partnership for adoption in the future, suggesting that consideration during future measure feedback, and the rulemaking process in we use a phased approach for measure development. which we respond to stakeholder implementation whereby the measures Comment: Many commenters comments. We encourage continued would be reported outside of the ESRD supported a measure on transfusions if engagement by the kidney care QIP for 1 year prior to adoption of the this measure assessed transfusions that community in this process, both in measure in the ESRD QIP; commenters are within the control of ESRD facilities. prioritizing additional measures, argued that this reporting period will One commenter suggested that, before supporting ongoing measure allow us to set a proper baseline for the measure is adopted, we wait to see development, and providing feedback clinical measures. the results of studies looking at when Response: We thank commenters for for currently implemented measures. transfusions are and are not within a their suggestions. In general, we seek to At present, we analyze all clinical facility’s control. One commenter collect at least 1 year of data through measures for validity and reliability, requested clarification regarding where claims or CROWNWeb before adopting and NQF endorsement is a key CMS accesses transfusion data, whether a measure for the ESRD QIP. However, consideration we take into account the information shows the underlying we make this assessment on a case-by- when deciding whether to propose to reason for the transfusion, and the case basis because of the importance of adopt clinical measures. Where timeframe for CMS’ access and analysis timely implementation of some endorsed measures are not available to of the data. measures (for example, measures that address key issues relevant to the ESRD Response: We appreciate the directly affect patient safety). We will population, we intend to consider comments and will take them into continue to consider these issues as the unendorsed measures until such consideration during future measure ESRD QIP evolves. development. endorsed measures are available. We Comment: One commenter Comment: Commenters also discussed agree that clinical measures should be encouraged us to improve the program the general principles CMS should fully specified at the time they are by maintaining a reasonable number of embrace in future years of the program. proposed. measures in order to reduce Commenters encouraged us to work We believe that, generally, it is administrative costs and publicly with the kidney care community to helpful to both the ESRD QIP reporting quality measures on DFC. adopt a strategic vision for the ESRD community and CMS to phase-in Response: As the ESRD QIP evolves QIP, specifically the criteria and process measures as the commenter suggests. from year-to-year, we seek to for the adoption of measures and We do not entirely understand the continuously evaluate the effectiveness domains. One commenter requested that comment stating that we should score of the measure set, burden to providers, CMS and other stakeholders agree on facilities based on the lesser of the and clarity for beneficiaries. the timeline and process for future facility’s performance or the national measure development. Commenters also performance rate. We take this to mean a. Thirty-Day Hospital Readmissions urged us to provide the criteria used to that we should use a scoring One of the major areas our VBP select measures, recommending the methodology similar to PY 2012 and PY programs seek to promote is care NQF selection criteria, and engage the 2013 for new measures. At this time, we coordination. Care coordination Measures Application Partnership in believe the objectives of the program are measures assess caregivers not only on identifying measures to include in the best served by scoring facilities using the care directly under their control, but program and their weighting. In the achievement and improvement also on their success in coordinating selecting measures, commenters stated scoring methodology for the reasons care with other providers and suppliers. that every measure should (i) have a discussed below. Hospital readmission is often the verified entity responsible to maintain Comment: Some commenters support outcome of uncoordinated care. Care and update it at least once every three additional measures but requested that coordination measures encourage years; and (ii) be fully and clearly they be implemented no sooner than PY primary caregivers, ESRD facilities, specified and tested for reliability and 2018 since CROWNWeb has just physicians, and hospitals to work validity. Commenters also launched and data collection would together to improve the quality of care. recommended that we phase measures likely be through CROWNWeb. A 30-day hospital readmissions measure into the program, requiring reporting of Response: We recognize that is a primary example of care the measure outside of the ESRD QIP for CROWNWeb is a new data collection coordination. This measure is currently at least 1year, and once a measure is system and plan to take that into under development for the ESRD QIP, added, we score facilities based on the consideration while developing and and we requested comment regarding lesser of the facility’s performance or implementing ESRD QIP measures in our use of such a measure in future the national performance rate, at least the future. payment years.

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The comments we received on this commenters noted that an efficiency and technology prior to implementing topic and our responses are set forth measure is not necessary because of the care coordination measures. One below. bundled payment. Many commenters commenter suggested that we analyze Comment: Commenters made many asked that, if such a measure is the following factors when assessing suggestions with regard to a 30-Day developed, it be case-mix adjusted for access to care: (i) Miles traveled to Readmissions measure. Some nursing home residents, homeless facility; (ii) time required to commute to commenters did not support the patients, and drug and alcohol abuse to facility; and (iii) method of adoption of this measure for the ESRD discourage cherry-picking. One transportation/responsible party. QIP, arguing that facilities cannot commenter cautioned us to explore the Response: We thank the commenters always control hospitalization, and unintended consequences which may for expressing interest in addressing the suggested that facilities would be better result from this measure, and another issue of access to care. We are sensitive suited to use this type of measure in a commenter requested that we engage in to the particular role access to care can coordinated care setting. One more studies defining ‘‘efficiency’’ play for ESRD patients, and the commenter encouraged us to adopt this before we adopt a measure. limitations encountered in collecting measure in place of an SHR measure Response: We thank our commenters relevant data. Clinical measures because a 30-Day Readmission measure for their input regarding the assessing mortality and hospitalization is more likely to increase care consideration of an efficiency measure in the ESRD population were proposed coordination and less likely to for implementation in the ESRD QIP. in the PY 2014 ESRD QIP, and we have encourage cherry-picking. One We will take these suggestions into incorporated risk adjustment for commenter suggested that a 30-Day account as we develop measures for comorbidities in the specifications for Readmission measure include a grace future years of the ESRD QIP. these measures, but it is not clear to us period of 10–14 days for which the how effectively this risk-adjustment can c. Population/Community Health facility would not be held responsible, address problems with access. Factors preventing facilities from being We are aware that unintended such as distance traveled are not penalized if the patient received low- consequences, specifically those captured by claims data. We believe that quality care in the hospital, and limiting involving access to care, may result exclusion of the suggested groups the possibility that facilities could turn from the ESRD QIP. To address these (homeless, nursing home patients, etc.) away patients who have recently been concerns, we are currently monitoring from quality measures may protect hospitalized. This commenter also access to care and exploring the access for these groups, but would fail pointed out that the hospital 30-Day development of new measures or to adequately address issues for quality Readmissions measure does not include adjustments to existing measures that of care in those patients who are most ESRD patients and argued that hospitals would mitigate the unintended at risk for poor health outcomes. We are should be held responsible for consequences and/or incentivize also concerned that such exclusions readmissions during the grace period facilities caring for patients who may, may excuse facilities from taking steps the commenter suggests. One generally, contribute to lower facility toward more effective coordination of commenter requested that the measure rates. We requested comment care. We respectfully disagree that care community be able to review the on developing such a measure or coordination is not practical. Rather, we findings of the Hospitalization TEP that adjustments to measures, specifically believe it is a vital element of care for CMS held in May 2012 before this type with regard to access to care issues. a population that is by definition at of measure is adopted. The comments we received on this particular risk for transitions into and Response: We appreciate the topic and our responses are set forth out of care settings such as acute care comments regarding our consideration below. hospitals. It is particularly important for of a 30-day readmission measure and Comment: Many commenters those patients who reside in long-term will take them into consideration in provided feedback on a possible access care facilities such as nursing homes, or future rulemaking. We note that it is our to care measure. Some commenters who must seek care for chronic policy to make publicly available the encouraged the development of such conditions related to mental health results of measure development TEPs measures. Many of these commenters issues or drug/alcohol abuse to receive through http://www.cms.gov/Medicare/ suggested that, instead of creating a care that is coordinated since these Quality-Initiatives-Patient-Assessment- measure to assess access to care, we individuals often receive extensive care Instruments/MMS/ develop comorbidity adjustments for from various types of providers. TechnicalExpertPanels.html. quality measures that would ease facilities’ concerns about treating these 6. Scoring Background and General b. Efficiency patients. Commenters who serve aging Considerations for the PY 2015 ESRD QIP One of the main goals of our VBP patients with multiple comorbidities programs is not only to enhance quality believe there needs to be further Section 1881(h)(3)(A)(i) of the Act of care but also improve efficiency in consideration for facilities caring for requires the Secretary to develop a providing that care. At present, we are these types of patient populations. methodology for assessing the total not aware of an efficiency measure that Other commenters noted that present performance of each facility based on is appropriate for the ESRD population. and future measures should exclude the performance standards established We noted, however, that we were homeless patients, nursing home with respect to the measures selected for interested in receiving comments patients, and patients with the performance period. For the PY regarding this concept. comorbidities of drug/alcohol abuse and 2014 ESRD QIP, we adopted a The comments we received on this mental health issues to protect access to performance scoring methodology that topic and our responses are set forth care for these patients. Several assessed facilities on both their below. commenters believe that care achievement and improvement on Comment: We received many coordination is important but is not clinical measures. We stated that we comments regarding our proposal of practical due to data timing issues and believe that this scoring methodology developing and adopting an efficiency knowledge of staff; these commenters will more accurately reflect a facility’s measure in future years. Several suggested that CMS fund additional staff performance on the measures because it

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will enable us to differentiate between Therefore, for the PY 2015 ESRD QIP, future. We believe that CROWNWeb facilities that simply meet the we proposed to establish CY 2013 as the will be valuable in this effort once it has performance standards, those that performance period for all of the been successfully launched for a period exceed the performance standards by measures. We requested comments on of time, and we are confident that the varying amounts, and those that fall this proposal. data submission and validity issues short of the performance standards. We The comments we received on these have been resolved. also stated that we believe that the PY proposals and our responses are set Comment: One commenter suggested 2014 methodology appropriately forth below. that we consider employing rolling 12- incentivizes facilities to both achieve Comment: Commenters supported our month performance periods with high Total Performance Scores and proposal to use CY 2013 as the payment updated quarterly. improve the quality of care they provide performance period for the PY 2015 Response: At this time, we are not (76 FR 70272). We believe that the ESRD QIP; some commenters able to implement a rolling 12-month methodology set forth for PY 2014 specifically supported a performance performance period that is updated on continues to incentivize facilities to period that allows us to set standards a quarterly basis because we do not have meet the goals of the ESRD QIP; before the performance period begins. the systems or resources in place to therefore, with the exception of the Some commenters, while supporting calculate scores, answer inquiries, and proposed changes in the proposed rule this performance period, cautioned us provide Performance Score Certificates (77 FR 40976), we proposed to adopt a against using data from CROWNWeb more than once per year. We will, scoring methodology for the PY 2015 from this period since CY 2013 will be however, continue to consider this ESRD QIP that is nearly identical to the the first full year CROWNWeb is suggestion as the ESRD QIP evolves. PY 2014 ESRD QIP. implemented. For the reasons stated above, we The comments we received on this Response: We thank commenters for finalize CY 2013 as the performance proposal and our responses are set forth their support. We note that, because we period for the PY 2015 ESRD QIP as below. are not finalizing the Hypercalcemia proposed. Comment: Several commenters measure, we are no longer using data 8. Performance Standards for the PY supported our proposal to use the PY from CROWNWeb for purposes of 2014 scoring methodology in the PY scoring any clinical measure for the PY 2015 ESRD QIP 2015 ESRD QIP. 2015 ESRD QIP. For purposes of the PY Similar to the PY 2014 ESRD QIP, we Response: We thank commenters for 2015 ESRD QIP, we will be using proposed to adopt performance their support. We will finalize our CROWNWeb to collect data only for the standards for the PY 2015 ESRD QIP proposals to use the PY 2014 scoring Mineral Metabolism reporting measure. measures under section 1881(h)(4)(A) of methodology for use in the PY 2015 We believe that this is appropriate since the Act. This section provides that ‘‘the program with the modifications facilities will only be required to report Secretary shall establish performance discussed below. We believe that these data, but will not be scored based on standards with respect to measures modifications improve the efficacy of these data for PY 2015. We believe that selected * * * for a performance period the program for the reasons discussed. CROWNWeb is sufficiently with respect to a year.’’ Section implemented to allow successful 7. Performance Period for the PY 2015 1881(h)(4)(B) of the Act further provides reporting for CY 2013. We will continue ESRD QIP that the ‘‘performance standards * * * to assess the appropriateness of shall include levels of achievement and Section 1881(h)(4)(D) of the Act CROWNWeb data for inclusion for improvement, as determined requires the Secretary to establish the purposes of clinical measures in the appropriate by the Secretary.’’ We use performance period with respect to a ESRD QIP. the performance standards to establish year. For the PY 2014 ESRD QIP, we Comment: Many commenters asked the minimum score a facility must finalized a performance period of CY us to shorten the data lag between the achieve to avoid a payment reduction. 2012. We stated that we believe that, at performance period and the payment this point, a 12-month performance reduction/public reporting of the data so a. Clinical Measure Performance period is the most appropriate for the that the data can remain relevant. Standards program because this period accounts Commenters suggested that With respect to the seven proposed for any potential seasonal variations that CROWNWeb could be used to reduce clinical measures, we proposed to set might affect a facility’s score on some of these data lag. the PY 2015 improvement performance the measures, and also provides Response: For PY 2015, we have standard and achievement performance adequate incentive and feedback for determined that data derived from standard (collectively, the ‘‘performance facilities and Medicare beneficiaries (76 claims is the most appropriate source on standard’’) for each measure at the FR 70271). We continue to believe that which to score facilities on clinical national performance rate (which we a 12-month performance period will measures because this source is the would define as the 50th percentile) of best meet these policy objectives, and most complete and representative of the all facilities’ performance on the we considered what 12-month period greatest number of facilities. Because measure during CY 2011 (the proposed would be closest in time to the payment claims take more time to compile and comparison period—discussed in more year but would still allow us to time to calculate than other data sources to detail below). operationalize the program, calculate ensure reliability, there is a lag between For the PY 2014 ESRD QIP, we set the scores, and allow facilities a period of the time when the claims are submitted performance standards at the national time to preview and ask questions for processing and the time that the performance rate during a baseline regarding these scores before they are claims become available to calculate period of July 1, 2010–June 30, 2011. published and impact payment. We ESRD QIP measure rates. We also This period of time, however, did not determined that CY 2013 is the latest believe it is important to allow facilities allow us to publish the numerical period of time during which we can a period of time to review their scores values for the performance standards collect a full 12 months of data and still before the payment adjustments take concurrently with the final rule because implement the payment reductions place. We are considering how we might of the length of time needed for us to beginning with January 1, 2015 services. be able to shorten this timeline in the compile claims-based measure data at

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the individual facility level and For two of the PY 2015 measure the same formula that they used to calculate the measure rates. Instead, we topics, Kt/V Dialysis Adequacy and report it under the CROWNWeb pilot. included an estimate of the numerical Hypercalcemia, we noted that we do not For this reason, we proposed to values for the performance standards in possess data for the entirety of CY 2011, calculate the performance standards for the final rule, using nine months of the year on which we proposed to base the three proposed Kt/V measures using data, and posted the numerical values of the performance standards. We did not CY 2011 claims data. This is the best the performance standards based on the begin collecting uniform data on the Kt/ data we have available at this time to set full 12 months of data on http:// V hemodialysis adequacy measure until reliable performance standards for Kt/V. www.dialysisreports.org/pdf/esrd/ January 1, 2012 (see Change Request We stated that we understand that public-measures/UpdatedBaseline- 7460), and, under the conditions for stakeholders may be concerned about 2014–FR.pdf by the end of December coverage, facilities were not required to the nuances of the data and we invited 2011. In order to ensure that we have report serum calcium values that will be public comment on this proposal. enough time to calculate and assign used to calculate the Hypercalcemia We noted that if, after consideration numerical values to the proposed clinical measure until their submission of the comments, we decided to not performance standards for the PY 2015 of May, 2012 data with the June 2012 adopt the adult, hemodialysis Kt/V program, we proposed to set the national implementation of measure for PY 2015, we would performance standards based on the CROWNWeb. Despite these issues, we continue to use URR as a measure of national performance rate (that is, the stated that we do have data on which hemodialysis adequacy for this 50th percentile) of facility performance we can base performance standards. We population. We also noted that the NQF- in CY 2011. We noted that by choosing noted that although facilities are not yet endorsed measure for Kt/V measure for this time period for PY 2015, however, required to report serum calcium levels, peritoneal dialysis adequacy does not the data on which we base the approximately 63 percent of facilities, specify the body surface area formulae performance standards would only which treat approximately 80 percent of or the total body water formulae to capture 6 months of more recent data the Medicare ESRD patient population, utilize; and we would accept the when compared to PY 2014 and would have been voluntarily reporting these submission of peritoneal adequacy Kt/V also overlap with 6 months of the data data via CROWNWeb piloting since July values that utilize the methods currently used to calculate the PY 2014 2008. Additionally, we compared the in use as industry standards. We believe performance standards. We stated our serum calcium values reported by it is important to include peritoneal concern that if we finalize this period of facilities in 2010 as part of a clinical dialysis patients in the ESRD QIP and time, we would not be adequately data reporting program called ELab,6 to we solicited comments on the inclusion addressing stakeholder requests that we values that have been voluntarily of the peritoneal dialysis Kt/V adequacy take steps to minimize the length of reported by facilities in 2010 through measure. We proposed that, were we to ‘‘data lag’’ between the dates used to CROWNWeb, and the values are retain the URR measure for adult calculate the performance standards and significantly similar. We stated our hemodialysis, we would still adopt the the payment year. We recognized that belief that these similarities will also Kt/V peritoneal dialysis measure. We stakeholders might prefer that we base extend to data reported in 2011. proposed that these measures would performance standards on data as close Therefore, we proposed to calculate still comprise a Dialysis Adequacy in time to PY 2015 as possible. performance standards for the measure topic and would be scored in We stated that the period of time Hypercalcemia measure using the data the same manner as we proposed for the closest to the payment year that would that we collected via CROWNWeb Pilots Kt/V measures, below. allow us to post the numerical values collected during CY 2011. Even with the challenges outlined for the performance standards before the Uniform Kt/V reporting for above, we believed that the advantages end of the first month of the hemodialysis patients did not begin of adopting the Kt/V hemodialysis performance period is parallel to that of until January 1, 2012 (CR 7640). Before measure for PY 2015 outweigh the PY 2014, from July 1, 2011 through June this time, facilities could use a number disadvantages. Therefore, we proposed 30, 2012. As with PY 2014, selecting of different methodologies to calculate Kt/V as the measure for hemodialysis this time period for purposes of Kt/V values, with the result that the adequacy for PY 2015, but we calculating numerical values for the values could be different depending on specifically solicited comments performance standards would not allow which methodology was used. We regarding whether we should continue us to publish these numerical values stated in the proposed rule that we have to use URR for adult hemodialysis until late 2012 or early 2013, which is analyzed the data collected during the patients for PY 2015.7 closer in time and may possibly be CROWNWeb pilot and found that 88 We also considered calculating during the performance period. percent of facilities that reported to performance standards for the Kt/V However, as in PY 2014, we would still CROWNWeb had reported Kt/V values Dialysis Adequacy measure topic based be able to provide estimates for the using a NQF specified calculation on data from January 1, 2012–June 30, numerical values of the performance method (this method is also specified in 2012, to ensure that the data was standards at the time of final rule Change Request 7640) that yields calculated consistently. We are, publication and post the actual numbers consistent results and that is part of the however, aware that a shortened data as soon as they are available in specifications for each of the period may affect the measure rates’ December 2012 or January 2013. hemodialysis Kt/V measures that we reliability. Therefore, we proposed to Based on these considerations, we proposed to adopt for the PY 2015 calculate performance standards based proposed CY 2011 as the basis for the program. Though we are not able to tell performance standards (that is, the what calculation method a facility used 7 Note that, as further explained below, the issue national performance rates). We did, by reviewing a claim, we believe it is we have discussed with respect to the reporting of however, request comment concerning reasonable to assume that roughly the Kt/V values prior to CY 2012 would not be an issue whether we should instead use data same percentage of facilities reported for the calculation of improvement scores because we proposed CY 2012 as the period used to closer in time to the payment year and Kt/V on their claims prior to 2012 using calculate the improvement threshold; beginning set the performance standards using July January 1, 2012, all facilities are required to report 1, 2011 through June 30, 2012 data. 6 http://www.esrdnet11.org. Kt/V uniformly on their claims.

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on the data from CY 2011 discussed Furthermore, we believe it is important measure and the Vascular Access Type above, but we invited comment on an to incentivize the best care possible. measure topic) have not declined. alternative 6 month period beginning on For these reasons, we finalize our Therefore, for PY 2015, we will use the or after the date on which uniform proposal to establish performance performance standards in the above reporting began, January 1, 2012. standards for the PY 2015 ESRD QIP table. If we discover that performance The comments we received on these clinical measures at the 50th percentile on any of the measures is declining in proposals and our responses are set of national performance during CY future years, we also intend to forth below. 2011. The numerical values for the investigate the precipitating causes and Comment: Many commenters agreed performance standards are set forth modify the ESRD QIP as necessary to with our proposal to use CY 2011 as the below in Table 5. ensure high quality care for comparison period for purposes of beneficiaries. calculating the performance standards b. Performance Standards because this period will allow facilities c. Performance Standards for the PY to view these standards when the final TABLE 5—FINALIZED NUMERICAL VAL- 2015 Reporting Measures rule is published. Others, however, UES FOR THE PERFORMANCE STAND- We established the performance expressed support for using data from ARDS FOR THE PY 2015 ESRD QIP standards for the reporting measures for July 1, 2011–June 30, 2012 to calculate CLINICAL MEASURES PY 2014 based upon whether facilities the performance standards because this met certain reporting requirements period is closest in time to the Performance rather than achieved or improved on performance period. Some commenters Measure standard specific clinical values. We proposed to % did not have a preference for the establish the same performance comparison period, but requested that Hemoglobin > 12 g/dL ...... 1 standard for the ICH CAHPS reporting we be consistent in the time periods we Vascular Access Type ...... measure for PY 2015 that we established choose. Many commenters suggested % Fistula ...... 60 for PY 2014. Under this proposed that, regardless of the time period, we % Catheter ...... 13 performance standard, facilities would do not use CROWNWeb data to Kt/V ...... be required to provide an attestation calculate performance standards Adult Hemodialysis ...... 93 that they successfully administered the because the data in CROWNWeb from Adult, Peritoneal Dialysis .. 84 ICH CAHPS survey via a third party in this time period is largely from large Pediatric Hemodialysis ...... 93 accordance with the measure dialysis organizations (LDOs). specifications. We proposed that this In accordance with our statements in Response: Although we appreciate attestation must be completed in the CY 2012 ESRD PPS final rule (76 FR that July 1, 2011–June 30, 2012 is closer CROWNWeb by January 31, 2014. in time to the performance period, we 70273), if the final numerical values for For the NHSN Dialysis Event believe that it will be more beneficial to the PY 2015 performance standards are reporting measure, we proposed to set facilities if they are familiar with the worse than PY 2014 for a measure, we the performance standard as performance standards against which proposed to substitute the PY 2014 successfully reporting 12 months of data their performance will be evaluated performance standard for that measure. from CY 2013. If a facility has not yet before the performance period begins. We stated our belief that the ESRD QIP enrolled and trained in the NHSN We will continue to evaluate whether it should not have lower standards than dialysis event system, we proposed that will be feasible in the future to adopt previous years. We requested comments the performance standard for that performance standards using data from on this proposal. facility would also include completion a period closer in time to the The comments we received on these of these requirements. performance period and also make those proposals and our responses are set For the Mineral Metabolism reporting standards public before the beginning of forth below. measure, we proposed to set the the performance period. Additionally, Comment: One commenter did not performance standard as successfully as we stated above, we will not be support our proposal to keep reporting serum phosphorus and finalizing the Hypercalcemia measure performance standards at least as high calcium values for all qualified patients for PY 2015. All of the other clinical as they were the previous year and for 12 months. measures we are adopting for PY 2015 suggests that we, instead, investigate For the Anemia Management are claims-based, and we can set the why a performance standard would reporting measure we proposed to set performance standards for those drop. Another commenter agreed with the performance standard as measures without using CROWNWeb our proposal and stated that the only successfully reporting hemoglobin or data. reason that performance standards hematocrit and ESA dosage (if Comment: One commenter expressed should be lower than they were the applicable) for all qualified patients for concern that the standards are too rigid previous year is if we discover a major 12 months. and we expect perfection. technical issue with the previous year’s We requested comment on these Response: We believe that the standards, such as that the performance proposals. We did not receive any standards that we are setting are standards were miscalculated. comments on these proposals. We will, appropriate. It is the past performance Response: We believe it is important therefore, finalize the reporting measure of facilities nationally which determine to encourage improvement as the ESRD performance standards as proposed. the performance standards; thus, ESRD QIP evolves to ensure that beneficiaries facilities have demonstrated their ability continue to receive quality care at 9. Scoring for the PY 2015 ESRD QIP to achieve these standards. achievable levels. Therefore, we will Measures Additionally, to avoid a payment finalize our proposal to utilize previous In order to assess whether a facility reduction, facilities need only meet the years’ performance standards if they are has met the performance standards, we minimum Total Performance Score. As higher than those of the next year. The finalized a methodology for the PY 2014 discussed below, a facility need not performance standards for the measures program under which we separately have a perfect score on all, or any, of the used in previous years of the ESRD QIP score each clinical and reporting measures to meet this minimum. (the Hemoglobin Greater than 12 g/dL measure. We score facilities based on an

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achievement and improvement scoring to calculate the performance standards, percentile so that lower-performing methodology for purposes of assessing achievement thresholds, and facilities are incentivized to provide their performance on the clinical benchmarks) because, as we explained high quality care; if the thresholds are measures. Under the PY 2014 ESRD QIP above, we do not have complete facility set too high, it is possible that a facility scoring methodology, a facility’s level CY 2011 data that we can use to would not be incentivized to perform performance on each of the clinical calculate an improvement threshold for well because the cost to meet the measures is determined based on the every facility on the Kt/V Dialysis achievement threshold would be so high higher of (i) an achievement score or (ii) Adequacy measures. Rather than that it would outweigh the overall loss an improvement score (76 FR 70273). proposing to adopt a policy under of revenue resulting from the ESRD QIP We proposed to use a similar which no facility could receive an payment reduction. Although we do not methodology for purposes of scoring improvement score on these measures, believe we should award low- facility performance on each of the we proposed to use data from CY 2012 performing facilities a large number of clinical measures for the PY 2015 ESRD to calculate the improvement points, we do believe it is important to QIP. thresholds. Additionally, we stated our set the standards to incentivize all As in PY 2014, in determining a belief that by using CY 2012 to calculate facilities to perform better. facility’s achievement score for the PY the improvement thresholds, we will Comment: One commenter suggested 2015 program, we proposed that more closely align timing of the that we rename the achievement facilities would, based on their payment reduction with the period of threshold the ‘‘Statistical Performance performance in CY 2013 (the proposed time we use to calculate improvement Floor’’ because ‘‘achievement’’ seems performance period), receive points thresholds. We requested comments on misleading if the floor is set at the 15th along an achievement range, which we our proposal to use data from CY 2012 percentile. This commenter also would define as a scale that runs from to calculate improvement thresholds. recommended that the facility the achievement threshold to the When considering the time period we performance rate be renamed the benchmark. We proposed to define the would use to calculate improvement ‘‘Facility’s Current Year Performance achievement threshold for each of the thresholds, we sought to mitigate data Rate,’’ the benchmark be renamed the proposed clinical measures as the 15th lag issues as much as possible by ‘‘Exceptional Performance Rate’’ since it percentile of national facility selecting a period in time as close as is at the 90th percentile, and the performance during CY 2011. We stated possible to the performance period. performance standard be renamed the our belief that this achievement However, to entirely mitigate this data ‘‘National Average/Median Performance threshold will provide an incentive for lag, we also considered a period that Rate in the Base Year.’’ facilities to continuously improve their would take place during the Response: One of the ways we can performance while not reducing the performance period. Using this make the ESRD QIP transparent is by incentives to facilities that score at or approach, to calculate an improvement seeking to achieve consistency from above the national performance rate for score, we would derive an improvement year-to-year, provided there is not a the clinical measures (76 FR 70276). We threshold from either the first quarter of contravening interest. Changing the proposed to define the benchmark as the CY 2013 or the first 6 months of CY terminology of the achievement 90th percentile of the national facility 2013 and compare it to the facility’s threshold, performance rate, performance during CY 2011 because it measure rate in the last quarter of CY performance standards, and benchmark represents a demonstrably high but 2013 or the last 6 months of CY 2013, could unnecessarily confuse both achievable standard of excellence that respectively. We ultimately decided to facilities and beneficiaries. the best performing facilities reached. not propose this approach because, Additionally, we seek to harmonize We further proposed that, for the when possible, we prefer to use 12 CMS’ value-based purchasing programs proposed Kt/V Dialysis Adequacy months of data to calculate measure as much as possible, and we use these measures and the proposed rates to ensure more reliable rates, naming conventions across programs. Hypercalcemia measure, we would use particularly for low-volume facilities. Comment: Several commenters argued the same data we proposed above to Additionally, using this approach, part that we are creating inconsistencies calculate the performance standards for of the performance period for purposes between the Conditions for Coverage purposes of calculating the achievement of calculating the facility’s performance (CfCs) and the ESRD QIP; these thresholds and the benchmarks for these rate and achievement score (all of CY commenters specifically argued that the measures. We requested comment on 2013) could overlap with the data we CfCs state that a facility cannot be these proposals. use to calculate the improvement penalized for patient non-compliance, In determining an improvement score threshold (first quarter or 6 months of but many of the ESRD QIP measures for the clinical measures, we proposed CY 2013). Although we proposed to effectively penalize facilities for patient that facilities would receive points calculate improvement thresholds based non-compliance. The commenter along an improvement range, defined as on data from CY 2012, we also suggested that we make allowances for a scale running between the requested comment regarding use of patient noncompliance in the ESRD improvement threshold and the these alternative periods for purposes of QIP’s design; one commenter benchmark. We proposed to define the calculating the improvement thresholds. specifically recommended that we improvement threshold as the facility’s The comments we received on these should require only 90 percent rate on the measure during CY 2012. proposals and our responses are set compliance from patients that visit the The facility’s improvement score would forth below. facility at least seven times per month be calculated by comparing its Comment: One commenter stated that, to reconcile the CfCs and the ESRD QIP. performance on the measure during CY to foster continued improvement, we Response: We do not believe that we 2013 (the proposed performance period) should consider raising the achievement are creating inconsistencies between the to its performance on the measure threshold over time to a level greater CfCs and the ESRD QIP, nor do we during CY 2012. We proposed to base than 15 percent. believe that the ESRD QIP penalizes the improvement threshold on data from Response: We believe that, at this facilities for patient non-compliance. CY 2012 rather than CY 2011 (the time, it is appropriate to set the Although patients’ compliance with the period of time we had proposed to use achievement threshold at the 15th plan of care is a factor in some of the

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measures, the quality of care is largely CY 2012 to calculate improvement For the reasons discussed above, we controlled by the facility’s treatment of thresholds. finalize our proposed definitions of the patients. Additionally, to the extent that Response: We thank the commenters achievement thresholds, benchmarks, patient non-compliance may be a factor, for their support. and improvement thresholds. We have facilities are not required to obtain Comment: One commenter suggested calculated the numerical values for the perfect results for every patient. To that the improvement threshold be achievement threshold and benchmarks avoid a payment reduction, as we renamed the ‘‘Facility’s Base Year based on data from CY 2011; we will explain below, a facility need only meet Performance Rate’’ since the calculate the numerical values for the improvement threshold does not the performance standards (that is, the improvement thresholds based on 50th percentile of national performance) represent a gain or level of individual facilities’ data from CY 2012. for each clinical measure during the improvement. The numerical values for the comparison period (for PY 2015, this Response: As noted above, we believe will be CY 2011) and score half of the it is important to use consistent achievement thresholds and possible points for the reporting terminology from year-to-year to ensure benchmarks for the PY 2015 ESRD QIP measures. transparency and comprehension in clinical measures are set forth below in Comment: Commenters agreed with both the ESRD QIP and across CMS’ Table 6. our proposal to use the facility’s rate in VBP programs.

TABLE 6—FINALIZED NUMERICAL VALUES OF ACHIEVEMENT THRESHOLDS AND BENCHMARKS FOR THE PY 2015 ESRD QIP CLINICAL MEASURES

Achievement Benchmark Measure threshold (percent) (percent)

Hemoglobin > 12 g/dL ...... 5 0 Vascular Access Type: % Fistula ...... 47 75 % Catheter ...... 22 5 Kt/V: Adult Hemodialysis ...... 86 97 Adult, Peritoneal Dialysis ...... 63 94 Pediatric Hemodialysis ...... 83 97

In accordance with our statements in years’ achievement threshold and • Equal to or greater than the the CY 2012 ESRD PPS final rule (76 FR benchmarks if they are higher than benchmark, the facility would receive 70273), if the final PY 2015 numerical those of the next year. The achievement 10 points for achievement; values for the achievement thresholds thresholds and benchmarks for the • Less than the achievement and benchmarks are worse than PY 2014 measures used in previous years of the threshold, the facility would receive 0 for a measure, we proposed to substitute ESRD QIP (the Hemoglobin Greater than points for achievement; or the PY 2014 achievement thresholds 12 g/dL measure and the Vascular • Equal to or greater than the and benchmarks for that measure. We Access Type measure topic) have not achievement threshold, but below the believe that the ESRD QIP should not declined. Therefore, for PY 2015, we benchmark, the following formula have lower standards than previous will use the performance standards in would be used to derive the years. We requested comments on this the above table. If we discover that achievement score: proposal. performance on any of the measures is [9 * ((Facility’s performance period The comments we received on these declining in future years, we also intend rate—achievement threshold)/ proposals and our responses are set to investigate the precipitating causes (benchmark—achievement threshold))] forth below. and modify the ESRD QIP as necessary + .5, with all scores rounded to the Comment: One commenter did not to ensure high quality care for nearest integer, with half rounded up. support our proposal to keep beneficiaries. Using this formula, a facility would achievement thresholds and receive a score of 1 to 9 points based on a. Scoring Facility Performance on benchmarks at least as high as they were a linear scale disturbing all points Clinical Measures Based on the previous year and suggests that we, proportionately between the Achievement instead, investigate why these values achievement threshold and the would drop. Another commenter agreed We proposed to award between 0 and benchmark so that the interval in with our proposal and stated that the 10 points for each of the clinical performance between the score needed only reason that performance standards measures. As noted, we proposed that to receive a given number of should be lower than they were the this score be based upon the higher of achievement points and one additional previous year is if we discover a major an achievement or improvement score achievement point is the same technical issue with the previous year’s on the measure. For purposes of scoring throughout the range of performance standards, such as that the performance achievement for the measures, we from the achievement threshold to the standards were miscalculated. proposed to base the score on where a benchmark. Response: We believe it is important facility’s performance falls relative to to encourage improvement as the ESRD the achievement threshold and the b. Scoring Facility Performance on QIP evolves to ensure that beneficiaries benchmark for that measure. We Clinical Measures Based on continue to receive quality care at proposed that, identical to PY 2014, if Improvement achievable levels. Therefore, we will a facility’s measure rate during the We proposed that facilities would finalize our proposal to utilize previous performance period is: earn between 0 and 9 points for each of

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the clinical measures based on how For the reasons stated above, we will that it successfully administered the much their performance on the measure finalize the proposed methodology for ICH CAHPS survey via a third party during CY 2013 improved from their scoring measures on achievement and during the performance period performance on the measure during CY improvement. according to the specification found at 2012. A unique improvement range for https://www.cahps.ahrq.gov/Surveys- c. Calculating the Reporting Measure each measure would be established for Guidance/ICH.aspx. Eligible facilities Scores each facility. We proposed that if a (facilities providing adult, in-center facility’s measure rate during the As noted, reporting measures differ hemodialysis) that do not provide such performance period is: from clinical measures in that they are an attestation would receive 0 points on • Less than the improvement not scored based on clinical values, but the measure. We proposed that this threshold, the facility would receive 0 rather, are scored based on whether attestation must be entered via points for improvement; or facilities are successful in achieving the CROWNWeb by January 31, 2014. We • Equal to or greater than the reporting requirements associated with note that the ICH CAHPS survey is only improvement threshold, but below the each of the measures. The criteria that available to adult patients who are benchmark, the following formula would apply to each reporting measure treated in-center. For purposes of the would be used to derive the are discussed below. ICH CAHPS reporting measure, we improvement score: With respect to the proposed Anemia determine whether a facility treats [10 * ((Facility performance period Management, Mineral Metabolism, and adult, in-center patients by referencing rate—Improvement threshold)/ NHSN Dialysis Event reporting the facility’s information in CMS data (Benchmark—Improvement measures, for each measure, we sources (that is, SIMS and threshold))]—.5, with all scores rounded proposed to award facilities: CROWNWeb). Facilities report the types to the nearest integer, with half rounded (i) 0 points for meeting the reporting of patients that they serve in these data up. requirements for less than 6-consecutive sources. If a facility lists adult in-center We note that if the facility’s score is months during the performance period; services, we proposed that the facility equal to or greater than the benchmark, (ii) 5 points for meeting the reporting would be required to comply with the it would receive 10 points on the requirements for at least 6-consecutive ICH CAHPS reporting measure. measure per the achievement score months during the performance period; We requested comment on the methodology discussed above. and proposed methodology for scoring the The comment we received on these (iii) 10 points for meeting the PY 2015 ESRD QIP reporting measures. proposals and our responses are set reporting requirements for all 12 months We also requested comment regarding forth below. of the performance period. whether facilities should receive points Comment: One commenter requested We believe that requiring 6- for partially reporting data and whether clarification on whether (i) a facility can consecutive months of data rather than such reporting need be for consecutive earn points if its performance rate is 6 non-consecutive months of data for a months. below the improvement threshold but facility to receive points on these The comments we received on these above the achievement threshold and measures will hold facilities to the proposals and our responses are set (ii) a facility can earn points if its highest level of quality, therefore, forth below. performance rate is below the facilities will be encouraged to continue Comment: Several commenters achievement threshold but above the to improve their reporting mechanisms requested that we award points for improvement threshold. A commenter throughout the performance period. We partial or non-consecutive reporting of also requested clarification regarding are concerned that awarding points for data. Other commenters recommended whether, when scoring improvement, 6 non-consecutive months of reporting that we modify our scoring of the NHSN we multiply the ((Facility performance may cause facilities to be less diligent in Dialysis Event, Anemia Management, period rate—Improvement threshold)/ their reporting efforts overall. We and Mineral Metabolism reporting (Benchmark—Improvement threshold))] specifically requested comment measures to allow facilities to gain by 10 before or after we subtract 0.5. regarding whether the proposed 6- points for non-consecutive reporting on Likewise, this commenter requested consecutive month reporting a point scale of 0–10. Commenters clarification for the achievement scoring requirement will improve quality more suggested that two should be subtracted on whether we multiply the ((Facility’s than a non-consecutive month reporting from the number of months for which performance period rate—achievement requirement. We also proposed, as the dialysis facility successfully meets threshold)/(benchmark—achievement discussed in more detail below, that the reporting requirements (rounding threshold))] by 9 before or after we add facilities would need to receive a CCN negative scores to zero), meaning that a 0.5. prior to July 1, 2013 in order to receive facility would have to report two Response: It is possible for a facility a score on a reporting measure. Finally, months of data before receiving points to earn achievement points even if that for purposes of the NHSN Dialysis Event on the measure. Commenters argued facility did not improve during the reporting measure, we proposed that to that this approach will encourage performance period as long as that be awarded 5 or 10 points, any facility facilities to consistently report even if facility’s performance period rate that has not yet enrolled and trained in consecutive reporting is not possible. exceeds the improvement threshold. the NHSN dialysis event system must One commenter argued that facilities Likewise, a facility can earn do so and must agree to the required should be required to report for all improvement points even if its measure consent (http://www.cdc.gov/nhsn/PDFs months in order to receive any points on rate during the performance period is /PurposesEligibilityRequirements this measure; alternatively, this below the achievement threshold Confidentiality.pdf). commenter urged us to require facilities provided that facility improved during With respect to the proposed ICH to report consecutive months of data. the performance period. Additionally, CAHPS reporting measure, we proposed Response: We thank commenters for the 0.5 is added or subtracted, for to retain the PY 2014 scoring these suggestions. The NHSN achievement and improvement methodology for the PY 2015 ESRD QIP. participation requirements state that respectively, as the last step in the An in-center hemodialysis facility will facilities must report at least 6 months equations. receive a score of 10 points if it attests of data during a calendar year to the

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dialysis event module to maintain active that facilities should receive credit for consecutive monthly reporting during status in the NHSN. We believe it is reporting non-consecutive months for the performance period. Additionally, important to align the scoring this measure; we agree with commenters we will award incremental points for requirements for the NHSN dialysis that this approach will encourage reporting more than 6 months of data. event reporting measure for the ESRD reporting because, even if a facility We will award points to facilities as QIP with the NHSN requirements, misses a month or many months, it can follows: which are intended to improve the still receive points on the measure. (i) 0 points for reporting less than 6 quality of the data submitted to the Additionally, NHSN requirements allow months of data; NHSN. Furthermore, we believe the non-consecutive reporting, but strongly (ii) 5 points for reporting 6 months of severity of bloodstream infections and encourage regular monthly reporting. data; and other vascular access-related infections We also agree with the commenters who among dialysis patients warrants more stated that facilities should be awarded (iii) 10 points for reporting 12 months extensive monitoring in order to prevent points on an incremental scale to of data. future events. We will, therefore, require incentivize reporting as much as (iv) If the facility reports more than 6 a minimum of 6 months of NHSN possible. Therefore, we will begin but less than 12 months of data, we will Dialysis Event reporting before awarding points for 6 months of award incremental points using the awarding facilities points. We believe reporting, and will not require following formula:

We will round the result of this formula measures, we believe that it is beneficial it should also apply to these reporting (with half rounded up) to generate a to encourage less than 6 months of measures. Additionally, as we discuss measure score from 5–10 points; as reporting so that we can receive data below, we will apply the scoring noted, facilities will earn points for from as many facilities as possible and methodology for the Anemia reporting non-consecutive months. use this data to develop a robust clinical Management and Mineral Metabolism As we discuss below, because of the measure in these areas. We believe that reporting measures to facilities that time it takes to train and enroll in the the Anemia Management and Mineral receive a CCN during the first 6 months NHSN Dialysis Event module, we do not Metabolism reporting measures should of the performance period. Taking all of believe that it is feasible for all facilities also allow facilities to receive credit for these elements into consideration, we receiving a CCN in the performance reporting non-consecutive months are finalizing a scoring methodology period to report at least 6 months of because we believe that this approach that will allow facilities to score points data. We will not apply the 6 month will encourage reporting even if a on the Mineral Metabolism and Anemia minimum requirement on these newly facility fails to report for a month or Management reporting measures opened facilities, as we believe this more. We agree with commenters that a provided that they receive a CCN before requirement would place significant facility should be required to report at July 1, 2013. In order to score above a undue burden on these facilities to least two months before it is awarded zero on these measures, a facility must report data during their initial year of points. Two months of reporting report at least three months of data. operation starting up their care delivery translates to reporting at a rate roughly and administration. Therefore, the equal to our achievement threshold for Therefore, we finalize that facilities NHSN Dialysis Event reporting measure clinical measures—15 percent. We have receiving a CCN before July 1, 2013 will will not apply to any facility receiving determined that this threshold is an score 0–10 points on the Anemia a CCN on or after January 1, 2013. appropriate marker for where a facility Management and Mineral Metabolism For the Mineral Metabolism and should start earning achievement points reporting measures using the following Anemia Management reporting on the clinical measures, and we believe formula:

We will round the result of this formula 10. Weighting the PY 2015 ESRD QIP individual measures to reflect priorities (with half rounded up) to generate a Measures and Calculation of the PY for quality improvement such as measure score from 0–10, and we will 2015 ESRD QIP Total Performance Score weighting the scores to ensure that allow facilities to earn points using the Section 1881(h)(3)(A)(iii) of the Act facilities have strong incentives to meet same formula for reporting non- provides that the methodology for or exceed anemia management and consecutive months. assessing facility total performance shall dialysis adequacy performance Additionally, we finalize the ICH include a process to weight the standards, as determined appropriate by CAHPS measure scoring as proposed. performance scores with respect to the Secretary. In determining how to

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appropriately weight the PY 2015 ESRD that the facility’s measure rates lead to the results could count for more points than QIP measures for purposes of following measure scores: HD—7; PD—8; another patient’s results, perhaps calculating Total Performance Scores, pediatric—5. To compute the Kt/V Dialysis incentivizing better care for only certain we considered two criteria. Specifically, Adequacy measure topic score for Facility X, ESRD populations. It is the goal of the we would calculate the following: (7*60/ ESRD QIP to provide the best care for we considered the number of measures 100)+(8*20/100)+(5*20/100) = 6.8, which we we had proposed to include in the PY would round to 7. The Kt/V Dialysis every patient, and we believe the 2015 ESRD QIP as well as the National Adequacy measure topic score would then be proposed weighting for measure topics Quality Strategy priorities. treated as one clinical measure when meets this goal. Therefore, we are calculating the Total Performance Score. finalizing the methodology of weighting a. Weighting Individual Measures To Example 2: Facility Y serves HD patients measure topics as proposed. Compute Measure Topic Scores for the and PD patients. For HD patients, Facility Y’s Kt/V Dialysis Adequacy Measure Topic Kt/V measure rate is 50/60; assume that this b. Weighting the Total Performance and the Vascular Access Type Measure rate leads to a score of 6. For PD patients, Score Topic Facility Y’s Kt/V measure rate is 4⁄7. Facility In the proposed rule we stated our Because the Kt/V Dialysis Adequacy Y has no Kt/V measure rate for pediatric belief that weighting the finalized patients because it does not serve this measure topic and the Vascular Access clinical measures/measure topics population. Assume that the minimum case equally will incentivize facilities to Type measure topic are comprised of number for scoring a measure is 11. Because multiple measures, it is necessary for us there are only seven cases in Facility Y’s improve and achieve high levels of to discuss how we will derive an overall denominator, Facility Y would not receive a performance across all of the measures, score for each measure topic. For these PD Kt/V measure score. Furthermore, Facility resulting in overall improvement in the measure topics, we proposed that each Y did not treat any pediatric patients, so it quality of care provided to ESRD measure be scored separately for each would not receive a pediatric Kt/V measure patients. We also stated our belief that, facility using the achievement and score. Therefore, the Kt/V Dialysis Adequacy while the reporting measures are improvement methodology discussed measure topic score for Facility Y would be valuable, the clinical measures value 6. The Kt/V Dialysis Adequacy would then above. After calculating the individual actual patient outcomes and therefore be treated as one clinical measure when justify a higher combined weight. We measure scores within a measure topic, calculating the Total Performance Score. we proposed to calculate a measure did, however, propose to weight the We requested comment on the clinical measures slightly less for the PY topic score using the following steps: (1) proposed method of weighting Dividing the number of patients in the 2015 ESRD QIP than we did for the PY individual measure scores to derive a 2014 ESRD QIP. For the PY 2015 ESRD denominator of each measure by the measure topic score. sum of the denominators for all of the QIP, we believe it is important to begin The comments we received on these to more rigorously incentivize reporting, applicable measures in the measure proposals and our responses are set topic; (2) multiplying that figure by the specifically since for three of the four forth below. reporting measures, we now require facility’s score on the measure; (3) Comment: Some commenters summing the results achieved for each actual data submission. We intend to supported our proposals for weighting use these data for purposes of measure; and (4) rounding this sum measure topics. Some commenters, (with half rounded up). We proposed developing and creating clinical however, raised concerns that, given the measures in the future; thus, complete that, if a facility does not have enough small number of pediatric patients patients to receive a score on one of the and correct data submission in these relative to adult patients, combining the areas is essential to the program’s measures in the measure topic (this adequacy measures might result in a proposal is discussed below), that overall goal of continued and improved score that does not accurately reflect the ESRD quality care. For these reasons, we measure would not be included in the quality of care provided to pediatric measure topic score for that facility. proposed to equally weight the clinical patients treated in adult dialysis measures/measure topics for which a Only one measure within the measure facilities. Other commenters suggested facility receives a score equal to 80 topic need have enough cases to be that the measure topics should be percent of the Total Performance Score; scored in order for the measure topic to weighted consistently across facilities to we also proposed to equally weight the be scored and included in the allow meaningful comparisons between reporting measures for which a facility calculation of the Total Performance facilities; these commenters requested receives a score as 20 percent of the Score. We stated that we believe it is that we modify the weighting so that Total Performance Score. We requested important to proportionately weight the each measure is weighted based on comment on this proposed methodology measures within a measure topic clinical relevance, importance, and the for weighting the clinical and reporting because we seek to give equal number of patients in a ‘‘typical’’ measures. importance to each patient. Finally, we facility’s population. We have also considered the issue proposed that the measure topic score Response: We disagree with the with awarding a Total Performance would be equal to one clinical measure commenters’ statement that combining Score to facilities that do not report data in the calculation of the Total the adequacy measures might not reflect on the proposed minimum number of Performance Score. the quality of care given to certain cases with respect to one or more of the For additional explanation of our patients. The weighting scheme ensures finalized measures/measure topics. As proposals to calculate measure topic that emphasis on each measure in the we stated in the CY 2012 ESRD PPS scores, we provided the following Kt/V measure topic is proportionate to final rule, we believe it is important to examples: the number of patients that facility include as many facilities as possible in Example 1: Facility X serves hemodialysis treats. If we were to weight the measure the ESRD QIP. We did, however, revisit (HD), peritoneal dialysis (PD), and pediatric topics consistently across facilities or our policy of including any facility that patients. For HD patients, Facility X’s Kt/V measure rate is 50/60. For PD patients, base the weight on clinical relevance or receives a score on one measure, Facility’s X’s Kt/V measure rate is 15/20. For the typical facility, the scoring whether that measure is a clinical or pediatric patients, Facility X’s Kt/V measure methodology would not equally weight reporting measure, and we proposed a rate is 10/20. There are 100 patients included the quality of care provided to each, different approach for PY 2015. We in the measure topic (60+20+20). Assume individual patient. That is, one patient’s stated our belief that it is preferable to

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require a facility to have at least one should weight the reporting measures at clinical outcomes should constitute the clinical and one reporting measure to 50 percent of the Total Performance majority of the Total Performance Score. receive a Total Performance Score. By Score. Some commenters stated their Therefore, we finalize that, for the PY requiring this minimum, we ensure that belief that we should maintain the 90/ 2015 ESRD QIP, each clinical measure/ a facility is not included in the program 10 Total Performance Score weighting measure topic will be equally weighted unless it meets the minimum case because clinical outcomes are more to comprise 75 percent of the Total requirement for at least one clinical important than simply tracking and Performance Score, and the reporting measure/measure topic. In the case of a relaying information. measures will be equally weighted to facility that has sufficient data (11 cases, Response: We believe, at this time, comprise 25 percent of the Total as discussed below) from the that it is appropriate to weight all of the Performance Score. performance period, but lacks sufficient clinical measures topics equally and all data (11 cases, as discussed below) to c. Examples of the PY 2015 ESRD QIP of the reporting measures equally in calculate the improvement threshold, Scoring Methodology we proposed to only calculate its order to equally incentivize quality in Below, we provide examples to achievement score, because it would not all of these areas of care. We do, be possible to calculate its improvement however, agree with the commenter that illustrate the scoring methodology for score. We requested comment on our noted that because of the importance of the PY 2015 ESRD QIP. Figures 1–3 proposals to require a facility to qualify reporting measures, such the NHSN illustrate the scoring for a clinical for a score on at least one reporting and Dialysis Event measure which tracks measure. Figure 1 shows Facility A’s one clinical measure in order to receive HAIs, we should give greater weight to performance on an example clinical a Total Performance Score. the reporting measures in calculating measure. Note that for this example Finally, we proposed that all Total the Total Performance Score. As stated clinical measure, the facility is Performance Scores be rounded to the above, we are not finalizing the attempting to achieve a high rate (that nearest integer, with half being rounded Hypercalcemia clinical measure due to is, the higher the measure rate, the up, and we requested comment on this our lack of consistent baseline data. higher the measure score). The example proposal. For further examples Instead, we will collect calcium data benchmark (which is the 90th percentile regarding the proposed measure and through the Mineral Metabolism of performance nationally in CY 2011) Total Performance Score calculations, reporting measure until we have calculated for this measure is 74 we refer readers to the figures below. baseline data that is robust enough to percent, and the example achievement The comments we received on these support a clinical measure’s adoption. threshold (which is the 15th percentile proposals and our responses are set Because of our need to collect data from of performance nationally in CY 2011) forth below. not only LDOs, as we did in the is 46 percent. Facility A’s performance Comment: Many commenters CROWNWeb pilot, but all types of rate of 86 percent during the supported our proposed scoring dialysis facilities, our decision to not performance period meets or exceeds methodology. Commenters specifically finalize the Hypercalcemia measure, the benchmark of 76 percent, so Facility supported our proposal to require a and the importance of collecting HAI A would earn 10 points (the maximum) facility to have a score for both a clinical data through the NHSN Dialysis Event for achievement for this measure. and a reporting measure to receive a reporting measure, we believe it is (Because, in this example, Facility A has Total Performance Score. One appropriate to weight the reporting earned the maximum number of points commenter stated that, because of the measures more than we had proposed. possible for this measure, its importance of preventing HAIs, we We continue to believe, however, that improvement score is irrelevant.)

Figure 2 shows the scoring for another from 26 percent in CY 2012 to 54 percent, and the benchmark is 74 facility, Facility B. As illustrated below, percent during the performance period. percent. the facility’s performance on the The achievement threshold is 46 example clinical measure improved percent, the performance standard is 58

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Because the facility’s performance improvement range, we must calculate measure score. To calculate the during the performance period is within both the improvement and achievement achievement score, we would employ both the achievement range and the score to find the example clinical the formula discussed above.

The result of this formula for this + .5, which equals 3.07 and we round Likewise, to calculate the example is [9 * ((54 ¥ 46)/(74 ¥ 46))] to 3. improvement score, we employ the improvement formula discussed above.

The result of this formula for this is 3, and its improvement score is 5. We In Figure 3 below, Facility C’s example is [10 * ((54 ¥ 26)/(74 ¥ 26))] award Facility B the higher of the two performance on the example clinical ¥ .5, which equals 5.33 and we round scores. Thus, Facility B’s score on this measure drops from 53 percent in CY to 5. Therefore, for this example clinical example measure is 5. 2012 to 40 percent in CY 2013, a decline measure, Facility B’s achievement score of 13 percent.

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Because Facility C’s performance during Total Performance Score = [(.375 * within a facility. Thus, in order for a the performance period falls below the Hemoglobin Greater Than 12g/dL facility to be scored on any clinical achievement threshold of 46 percent, it Measure) + (.375 * Kt/V Dialysis measure, we proposed that the facility receives 0 points for achievement. Adequacy Measure Topic) + (.0625 * must report a minimum number of cases Facility C also receives 0 points for NHSN Dialysis Event Reporting qualifying for that measure over the improvement because its performance Measure) + (.0625 * ICH CAHPS course of the 12-month performance during the performance period was Survey Reporting Measure) + (.0625 * period. This proposed minimum seeks lower than its improvement threshold Mineral Metabolism Reporting to ensure that facilities are being (its performance during CY 2012). Measure) + (.0625 * Anemia evaluated based on the care they Therefore, in this example, Facility C Management Reporting Measure)] * provide. would receive 0 points for the example 10 clinical measure. Again, the Total Performance Score a. Minimum Data for Scoring Clinical The method illustrated above would would be rounded to the nearest Measures for the PY 2015 ESRD QIP be applied to each clinical measure in integer (and any individual measure Dialysis facilities tend to have a small, order to obtain a score for each measure. values ending in .5 would be rounded Scores for reporting measures are to the next higher integer). relatively stable patient census, with calculated based upon their individual Finally, if, for example, a facility each facility reporting on an average of criteria, as proposed. qualified for only two of the reporting 50–60 cases per measure. In previous After calculating the scores for each measures, the facility’s Total rules, commenters have asked that we measure, we calculate the Total Performance Score would be calculated consider the effect of case size on Performance Score. As an example, as follows: measure reliability in the context of the applying the weighting criteria to a Total Performance Score = [(.25 * ESRD QIP. We recognize that as a facility that receives a score on all Hemoglobin Greater Than 12g/dL general principle, reliability improves finalized measures, we would calculate Measure) + (.25 * Kt/V Dialysis with increasing case size; that is, the the facility’s Total Performance Score Adequacy Measure Topic) + (.25 * reliability of a measure or score using the following formula: Vascular Access Type Measure Topic) describes numerically to what extent Total Performance Score = [(.25 * + (.125 * Mineral Metabolism that measure or score assesses the actual Hemoglobin Greater Than 12g/dL Reporting Measure) + (.125 * Anemia differences in performance among Measure) + (.25 * Kt/V Dialysis Management Reporting Measure)] * facilities as opposed to the random Adequacy Measure Topic) + (.25 * 10. variation within facilities. Furthermore, Vascular Access Type Measure Topic) Again, the Total Performance Score we wish to be responsive to public + (..0625 * NHSN Dialysis Event would be rounded to the nearest integer comment and to ensure that dialysis Reporting Measure) + (.0625 * ICH (and any individual measure values facilities with extremely small numbers CAHPS Survey Reporting Measure) + ending in .5 would be rounded to the of patients are not penalized by the (.0625 * Mineral Metabolism next higher integer). ESRD QIP due to random variation in Reporting Measure) + (.0625 * their patient samples. Thus, we Anemia Management Reporting 11. Minimum Data for Scoring Measures developed and proposed a new for the PY 2015 ESRD QIP Measure)] * 10. methodology to make favorable The Total Performance Score would be We proposed to only score facilities adjustments to the clinical measure rounded to the nearest integer (and on clinical measures for which they rates of facilities with very small any individual measure values ending have a minimum number of cases numbers of patients. We also proposed in .5 would be rounded to the next during the performance period. We a case minimum 8 for clinical measures higher integer). assessed how reliable each clinical to protect patient privacy, which we However, if, for example, a facility measure is using the currently available believe could be compromised if the did not receive a score on the Vascular data. Specifically, we studied the degree Access Type measure topic, the the measures assess the actual 8 For clarification purposes, as in previous years, facility’s Total Performance Score differences in performance among a ‘‘case’’ refers to a patient that is included in the would be calculated as follows: facilities as opposed to the variation measure.

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publicly reported data for a facility is the ratio of the between-facility variance reliability adjustment to account for a based on a small patient population. to the sum of the between-facility possible unfavorable skew in the Given the ESRD QIP’s potential to variance and the within-facility measure rate due to small sample size. encourage quality improvement, our variance. We proposed the following goal is to ensure the full participation of We found the reliability of the Total methodology to adjust the measure rate as many facilities as possible in the Performance Score to be acceptable for used to score facilities with 11–25 cases program. However, we must ensure that all strata (IUR>0.6). However, we for a given measure. The adjustment all measure rates capture a large enough recognize that facilities with very small factors in facility size and the standard number of patients so that the privacy numbers of patients are more likely to error of the measure, which can be of each patient is protected. A case have a lower IUR. In a facility with a estimated using an analysis of variance minimum allows us to achieve these low IUR, the case mix might potentially (ANOVA). This analysis allows us to policy objectives of measurement shift its measure rate higher or lower estimate how much better the measure reliability and patient privacy. than the rate the same facility would rate could have been if that facility were For the first 3 payment years of the report if it were treating an ‘‘average’’ treating an ‘‘average’’ population of ESRD QIP, we set the minimum number ESRD population. In the context of the patients and make a favorable of cases to be scored on a clinical ESRD QIP, a favorable skew would not adjustment to the facility’s score in that measure at 11. Eleven cases has have a negative effect on facility amount. For example, as a facility treats historically been the case minimum for payment, but an unfavorable skew more patients, the reliability of the displaying measures on DFC. We have potentially could result in the facility measure rate improves, and the determined that in the context of DFC, receiving a payment reduction. We difference between the facility’s 11 cases will meet the requirement that cannot identify which specific facilities measure rate and the measure rate we individual patients are not identifiable will have a low IUR until after the statistically would expect to see if the in the aggregate measure rate. Given that performance period has concluded. facility were treating an ‘‘average’’ panel we believe that 11 cases is sufficient to However, in performing the of patients decreases. Thus, the address privacy concerns and that our stratification analysis, we found that a magnitude of the adjustment factor policy objective is to maximize the favorable adjustment to the two strata increases as the number of cases number of facilities that participate in with the lowest number of cases would the ESRD QIP, we proposed to set a reduce the risk of penalizing facilities in decreases from 25 to 11. proposed case minimum threshold of 11 those strata for random within-facility Because the adjustment factor takes cases. Under this proposal, facilities variation. The average number of cases into account a facility’s performance must report at least 11 qualifying cases contributing to the Total Performance (standard error of the measure) and the over the course of the 12-month Score in the second stratum is 25. number of cases for the measure, it is performance period to be scored on a Accordingly, we developed and computed separately for each measure. given clinical measure. We sought proposed below a favorable adjustment The specific methodology we proposed public comment on this proposal. to the measure rates for facilities with at follows: We indicated in the CY 2012 ESRD least the minimum case threshold of 11 • ANOVA provides an estimate sw of PPS final rule that we would continue and fewer than the adjustment threshold the square root of within facility to assess the reliability of our measures of 26 cases. This methodology would variance, given by the within subject in future payment years of the program give facilities ‘‘the benefit of the doubt’’ mean square. (76 FR 70259). To further explore this and ensure that any error in measure • Then for the ith facility, the standard issue in response to comments, we rates due to a small number of cases will error of the average measure (denoted by evaluated the reliability of measure rates not adversely affect payment. xi is given by and the Total Performance Score for Specifically, we proposed that if a facilities of various sizes using the PY facility reports at least 26 cases during 2014 program clinical measures. the 12-month performance period on a Specifically, we performed a simulation measure, it would be scored based on its where ni is the number of patients in the of the PY 2014 QIP to calculate the raw performance rate on the measure. If ith facility. Now denote C as the Inter-Unit Reliability (IUR) stratified by the facility reports between 11 and 25 minimum case number. We proposed facility size. The IUR is a statistic cases during the 12-month performance the following adjustment for the original commonly adopted for assessing the period, it would be scored based on its score xi by introducing a weight reliability of measures or scores, and is raw performance rate plus a favorable depending on facility size.

where C is the lower bound of cases for o The new score is: ti = xi ¥ wi * when C=26, this implies that for facilities that will not receive any SE(xi). (If ti < 0%, we set ti = 0%). measures with 26 cases and above, no adjustment. We stated our belief that this allowance is made. We sought public • For measures where large values of approach gives facilities an allowance to comment on this methodology and the xi are good (that is, for the PY 2015 account for the uncertainty in the proposed adjustment threshold. While ESRD QIP, the fistula measure and the one model is presented above, we Kt/V Dialysis Adequacy measure topic): estimate xi by accounting for the size of the patient population in both weights invited comment on alternative o The new score is: ti = xi + wi * approaches that are consistent with our SE(xi). (If ti > 100%, we set ti = 100%). and standard errors. As explained intent to include as many facilities as • In cases where lower values of xi above, this allowance decreases when are better (that is, for the PY 2015 ESRD the case size increases (from 11 to 26 or possible in the ESRD QIP and at the QIP, the Hemoglobin Greater Than 12g/ more)—the larger the case size, the same time address concerns from dL and catheter measures): smaller the allowance. For example, stakeholders regarding the reliability of

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measures where there are small the argument that the adjuster could receive 10 points on a reporting numbers of cases. We stated our belief allow smaller facilities to seem better measure, the facility is scored on that that this adjustment is appropriate for than they are is of little concern. measure. If a new facility scores zero or the ESRD QIP considering the particular Although the adjuster will affect the 5 points on a reporting measure, it is not measure set and scoring methodology measure score, it will not affect the scored on that measure. As the program for PY 2015. As the program grows and measure rate. The rates that are evolves, we believe it is important to evolves, we noted that we will continue displayed to the public will be shown continuously push improvement in all to assess reliability based on the without an adjustment. Thus, a facilities—both old and new. measures and scoring methodology for beneficiary could continue to Additionally, we wish to incentivize that payment year. meaningfully compare facilities, new facilities to put reporting The comments we received on these regardless of the number of patients mechanisms in place as soon as proposals and our responses are set these facilities serve. possible. For these reasons, we forth below. Comment: Some commenters proposed to modify the reporting Comment: Many commenters requested that, if we adopted the measure minimum data requirement supported our proposal to use an proposed adjustment, we publish tables from that of PY 2014. adjustment for measure rates, especially with the values of sw to make the ESRD For PY 2015, we proposed that any because aging patients and patients with QIP as transparent and predictable as facility receiving a CCN before July 1, comorbidities can negatively affect a possible. 2013 be scored on the reporting small facility’s score. Commenters also Response: The sw values represent the measures. However, since a facility supported our proposal to use the within facility variation. It is specific to receiving a CCN after January 1, 2013 adjuster for measures with 11–25 cases. each facility and, because it will be would not be able to report a full 12 Other commenters did not support the based on 2013 data, it cannot be derived months of data, we stated our belief that proposed adjustment because it is until the end of the performance period. overly complicated, could mislead Therefore, we are not able to publish the it is not appropriate to require it to do patients, and could make low-volume sw values at this time. so in order to receive a full 10 points on facilities appear better than high-volume Comment: Some commenters the reporting measures. Instead, we facilities when they are not, in fact; encouraged us to continue to conduct proposed to score these facilities these commenters suggested that we analyses to determine the appropriate proportionately for the time for which raise the case minimum to at least 25 reliability of measures and the they have a CCN during the cases instead of employing the proposed minimum case number for future years performance period. To earn 10 points adjustment methodology. Some of the program. Some commenters on the ICH CAHPS reporting measure, commenters expressly stated that the suggested that, if we are concerned with we proposed to require that a facility proposed case minimum is not reliability and minimum case numbers, receiving a CCN between January 1, sufficient; other commenters argued that we employ longer performance periods 2013 and June 30, 2013 attest that it the proposed case minimum should be spanning multiple years. Commenters successfully administered the survey lowered because the proposal could also encouraged us to align the ESRD during the time for which it had a CCN preclude participation from many low- QIP minimum case number with other during the performance period. For volume facilities, specifically pediatric VBP programs. purposes of the Anemia Management, facilities. Response: We will continue to study NHSN Dialysis Event, and Mineral Response: Were we to set the case the reliability of measures and the Total Metabolism reporting measures, we minimum at 26 rather than 11, we Performance Score. We have and will proposed that if a facility receives a estimate that an additional 520, or an continue to consider using longer CCN on or after January 1, 2013, but additional 10 percent of, facilities performance periods on a measure-by- before July 1, 2013, it would receive 10 would be excluded from the program. measure basis. Although we strive to points for reporting for all months for Although lowering the case minimum align the VBP programs as much as which it has a CCN and 5 points for would include even more facilities, we possible, each program has unique consecutively reporting half of the do not believe it is appropriate to do so measures which may necessitate months for which it has a CCN during because of not only reliability but also different minimum case numbers. We the performance period. If a facility has privacy concerns. As we stated in the will continue to look for harmonization a CCN for an odd number of months, we proposed rule (77 FR 40984), we believe as much as is appropriate. proposed to round down to calculate the the adjustment balances the competing For the reasons stated above, we number of months for which it must concerns of reliability, privacy, and finalize the case minimum and report to receive 5 points. Finally, we inclusion. adjustment for clinical measures as proposed to begin counting the number Although it can be difficult to proposed. of months for which a facility is open understand the adjustment on the first day of the month after the methodology, we do not believe that b. Minimum Data Requirements for facility receives a CCN. For example, this concern alone should prevent us Reporting Measures by New Facilities assume a facility receives a CCN on from finalizing it as proposed. The For purposes of the PY 2014 ESRD March 15, 2013. In order for this facility adjustment will result in no harm to any QIP, we stated that a facility that to receive 10 points on the applicable facility; although a facility may not be receives a CCN on or after July 1, 2012 reporting measure, we proposed that it able to predict its Total Performance has the option to choose whether or not must report data from April 1, 2013– Score if some of its measures are subject it is scored on each reporting measure December 31, 2013 (or 9 months of to the adjustment, the facility will know (76 FR 70275). We considered using the data). In order for it to receive 5 points, that the adjuster will not negatively same approach for PY 2015 as we did we proposed that it must report half of affect its score. It could continue to in PY 2014 (that is, allowing new the months for which it is open, predict its minimum score and use this facilities to choose whether or not they consecutively. For the example facility score as a baseline for assessing whether will be scored on each reporting to receive 5 points, it would need to or not it will receive a payment measure). Under that approach, if a new report 4.5 months of data. Since we reduction. Additionally, we believe that facility reports enough information to proposed to round down, this facility

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would be required to report 4 months of after July 1, 2013. We requested Response: Consistent with our change data to receive 5 points. comment regarding these proposals. We to allow facilities to score 0–10 We realized that facilities receiving a also elicited comments regarding incremental points on the Anemia CCN on or after July 1, 2013, may have whether there would be a more Management and Mineral Metabolism difficulty meeting the requirements of appropriate way to score these new reporting measures, we will finalize the reporting measures, such as facilities on reporting measures so that changes to our proposed scoring enrolling and training for the NHSN they may be eligible for inclusion in the methodology for these measures for Dialysis Event reporting measure or ESRD QIP. facilities receiving a CCN between hiring a third-party to administer the The comments we received on these January 1, 2013 and June 30, 2013. ICH CAHPS survey, because of the short proposals and our responses are set Facilities receiving a CCN between period of time left in the performance forth below. period. We also stated our belief that it Comment: Commenters supported our January 1, 2013 and June 30, 2013, will is appropriate to reduce payment for a proposals regarding the reporting be able to score points in proportion to 1-year period based on less than 6 measures’ minimum data requirements their overall rate of monthly reporting months of performance. Therefore, we for new facilities; specifically, on the Anemia Management and proposed to exclude facilities receiving commenters supported our proposal to Mineral Metabolism reporting measures. a CCN on or after July 1, 2013 from the exempt facilities receiving a CCN after As we noted above, we believe it is requirements of the reporting measures. June 30, 2013 from the reporting important to require a minimum Because we finalized, as discussed measures. Some commenters suggested threshold for facilities to earn points on above, that a facility will not receive a that a facility that receives a CCN this measure. Thus, we finalize that a Total Performance Score unless it between January 2013 and June 2013 facility receiving a CCN after January 1, receives a score on at least one clinical should be required to begin reporting on 2013 but before June 30, 2013 can score and one reporting measure, finalizing the first day of the third month after the points on the Mineral Metabolism and this proposal would result in facilities facility receives a CCN to allow the Anemia Management reporting not being eligible for a payment facility to deploy its IT system and measures using the following formula: reduction if they receive a CCN on or enroll in CROWNWeb and NHSN.

We will round the result of this formula during the performance period to 12. Payment Reductions for the PY 2015 (with half rounded up) to achieve a comply with this measure. Therefore, ESRD QIP measure score from 0–10. we are finalizing that a facility that Section 1881(h)(3)(A)(ii) of the Act For purposes of the Anemia receives a CCN during the performance requires the Secretary to ensure that the Management and Mineral Metabolism period will be not be scored on the application of the scoring methodology reporting measures, we do not agree NHSN Dialysis Event reporting measure. with commenters that facilities should results in an appropriate distribution of be required to report the first day of the For the ICH CAHPS measure, we payment reductions across facilities third month after they receive their believe that facilities receiving a CCN such that facilities achieving the lowest CCN. A facility with a CCN may submit before July 1, 2013 should be able to Total Performance Scores receive the claims to Medicare. If a facility is hire a third-party administrator in time largest payment reductions. For PY submitting claims, it should be to administer the ICH CAHPS survey. 2014, we adopted an approach under reporting hemoglobin and ESA levels. It Although it may take some time for which a facility did not have to meet or should also be reporting in facilities to put this administrator in exceed the performance standards with CROWNWeb. Therefore, we do not place, it can begin doing so before it respect to each of the finalized clinical believe it is necessary to allow facilities receives a CCN. Therefore, we finalize measures to avoid receiving a payment more time on these measures, and we our proposals that, to earn 10 points on reduction under the ESRD QIP. Rather, finalize that facilities must begin the ICH CAHPS reporting measure, a even if a facility failed to meet or exceed reporting for these measures on the first facility receiving a CCN between the performance standards with respect day of the month after they receive their January 1, 2013 and June 30, 2013 must to one or more of these measures, the CCN. attest that it successfully administered facility could avoid a payment reduction if it achieved a minimum As we have previously noted, we the survey during the time for which it Total Performance Score that is equal to believe that a facility needs a period of had a CCN during the performance or greater than the minimum Total time after it receives its CCN to ensure period. that its systems are in place to report to Performance Score it would receive if it the NHSN system. As we explained We also finalize that facilities had met the performance standards for above, we are requiring facilities to receiving a CCN after June 30, 2013 will each of the clinical measures or, in the report 6 non-consecutive months of data be exempt from the Mineral case of the Vascular Access Type to receive points on the NHSN Dialysis Metabolism, Anemia Management, and Measure, for the two subcomponent Event measure. Because of the time ICH CAHPS reporting measures. For the measures. required to enroll and train in the NHSN NHSN Dialysis Event reporting measure, For PY 2014, in calculating this system, we do not believe it is equitable facilities will be exempt if they receive minimum Total Performance Score, we to require facilities receiving a CCN a CCN on or after January 1, 2013. excluded the reporting measures

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because we believed this approach best Comment: Commenters agreed with total points a facility could have underscored the importance of the our proposal to use the PY 2014 received had it met all of the reporting clinical measures. For PY 2015, we payment reductions scale for the PY requirements. As noted above, it is proposed to retain the same approach as 2015 ESRD QIP. Some commenters, possible to gain a total of 40 points from in PY 2014. We discuss the however, supported placing more the reporting measures; thus, we will methodology for deriving the emphasis on the reporting measures in include half, or 20 of these points, in performance standards for the measure calculating the minimum Total our calculation of the minimum Total topics, above. We requested comments Performance Score since these are the Performance Score. We believe this on these proposals. measures over which facilities have the approach is consistent with our Alternately, in order to better most control. Some commenters methodology for the clinical measures incentivize compliance with reporting suggested that we base payment since we calculate the clinical measure measures, we also considered raising reductions on actual impact rather than component of the minimum Total the minimum Total Performance Score projections of impact, setting tiers of Performance Score as the score a facility to include 50 percent of the total points reductions by percentage of facilities we would have received if it had reached a facility could have received had it met wish to be in each tier. Another the 50th percentile for all clinical all of the reporting requirements for commenter urged us to create a more measures. each measure. In other words, because individualized approach to payment Comment: One commenter suggested a facility could receive up to 40 points reductions because high quality care is that the 2 percent payment reduction be in PY 2015 for meeting all of the markedly different from patient to revisited since such a small percentage reporting measure requirements, we patient. will not be a worthwhile incentive as considered raising the minimum Total Response: At this time, we do not new measures are added. Several Performance Score by 20 points (one- believe it is in the best interest of the commenters expressed concern that the half of 40). This approach would ensure program to base payment reductions on ESRD QIP works as a penalty system that facilities receiving a CCN before actual impact and the percentage of and suggested that the ESRD QIP August 1, 2013 could still achieve the facilities to which we wish to provide provide incentives as well as penalties, minimum Total Performance Score by payment reductions. Regardless of the and on balance, be budget-neutral. One meeting, on average, the performance impact, we believe that facilities that do commenter suggested that the payment standards for the clinical measures and not meet the performance standards for reductions be returned to the penalized achieving as many points on the each of the clinical measures should facilities for use only to improve care in face a payment reduction. Were we to reporting measures as is possible. We the areas where they failed to meet base reductions on percentages, the requested comment regarding whether quality standards. result could be that some high the reporting measures should be scored performing facilities receive a payment Response: Section 1881(h) of the Act at greater than 0 when calculating the reduction. Our current payment does not provide us with the authority minimum Total Performance Score. reduction scale allows every facility to to issue bonus payments to facilities Section 1881(h)(3)(A)(ii) of the Act avoid a payment reduction provided based on their performance under the requires that facilities achieving the that they meet the minimum Total ESRD QIP, to make reductions of more lowest Total Performance Scores receive Performance Score. than 2.0 percent, or to redistribute the the largest payment reductions. For PY We agree that it is important to payment reductions to the originally 2014, we adopted an approach we provide individualized care to patients. penalized facilities. intend to continue for PY 2015. We We believe that the program, For the reasons stated above, we believe that this consistency will allow incentivizes facilities to furnish finalize our proposals for calculating the program to be more understandable individualized care within a certain payment reductions except that we will to both facilities and the general public. range of established, clinical acceptable include reporting measures in Accordingly, we proposed that the guidelines. calculating the minimum Total payment reduction scale be the same as Finally we agree with the commenters Performance Score. The reporting the PY 2014 program. Therefore, for that requested we place more emphasis measure component of the minimum each 10 points a facility falls below the on the reporting measures when Total Performance Score will equal the minimum Total Performance Score, it calculating the minimum Total score a facility would have received if would receive an additional 0.5 percent Performance Score. We specifically it is awarded half of the maximum payment reduction on its ESRD believe that this approach is appropriate points it could have received on the payments for PY 2015, with a maximum now that we have weighted the reporting measures (that is, 5 points on reduction of 2.0 percent. As we stated reporting measure to comprise 25 each measure). Based on this approach, in the CY 2012 ESRD PPS final rule (76 percent of the Total Performance Score. the minimum Total Performance Score FR 70281), we believe that such a Were we to continue to score the is 60 points. Facilities failing to meet sliding scale will incentivize facilities to reporting measures at zero when this minimum will receive payment meet the performance standards and calculating the minimum Total reductions in the amounts indicated in continue to improve their performance Performance Score, by increasing the Table 7 below. because even if a facility fails to achieve weight of the reporting measures, we the minimum Total Performance Score, would be decreasing the minimum Total TABLE 7—FINALIZED PAYMENT the facility will still be incentivized to Performance Score. This result is REDUCTION SCALE FOR PY 2015 strive for, and attain, better performance contrary to our belief stated in this final rates in order to reduce the amount of rule that the reporting measures should Total performance score Reduction (%) its payment reduction. We requested be afforded more importance. Therefore, comments on the proposed payment we will finalize the alternative approach 100–60 ...... 0 reduction scale. we requested comment on in the 59–50 ...... 0.5 The comments we received on these proposed rule to include the reporting 49–40 ...... 1.0 39–30 ...... 1.5 proposals and our responses are set measures in the minimum Total 29–0 ...... 2 .0 forth below. Performance Score at 50 percent of the

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13. Data Validation requested that, before the pilot program burdensome and suggests a 120 day One of the critical elements of the begins, we define the errors being period. Another commenter requested ESRD QIP’s success is ensuring that the sought and publish these for public that we limit the number of document data submitted to calculate measure comment. Another commenter stated requests based on provider size and scores and Total Performance Scores is that, before data validation efforts are resources and reimburse facilities for accurate. To that end, we have procured initiated, CMS should provide clear data requests. One commenter suggested the services of a data validation specifications, data definitions, and that the requested data sample be a contractor who will be tasked with reporting requirements because it would percentage of patients rather than a validating a national sample of facilities’ be inappropriate to penalize facilities fixed number so that small facilities are records as they report data under the when clarification questions or not disproportionally affected. One reporting issues have not been resolved. commenter asked that the requested ESRD QIP. Beginning in CY 2013, we Commenters also recommended that records be as current as possible so that proposed to begin a pilot data validation CMS include the initial data validation they can be easily accessed by facilities program for the ESRD QIP. Because data in the routine Comprehensive Error Rate that many have data storage protocols. validation for the ESRD QIP is new to Testing (CERT) request for RACs Another commenter specifically noted both facilities as well as CMS, we (Recovery Audit Contractors), but its support for HAI data validation, but believe that the first year of validation cautioned against paying auditors on a stated its concern that we should result in no payment reductions contingency fee. underestimated the burden on facilities; to facilities. Accordingly, we proposed Response: We thank commenters for this commenter requested that we that, beginning in CY 2013, we would their support of the pilot data validation provide more detail on the validation randomly sample the records of program. At this time, we are still process, specifically the facilities’ approximately 750 facilities. We finalizing the processes and procedures responsibilities, and encouraged us to anticipate that a CMS-designated for the pilot. We will provide this partner with NHSN and state and public contractor would request approximately information before the pilot program health partners in developing a 10 records from each of these facilities. begins on a publicly available Web site. standardized process for the validation We proposed that the facility must We will consider the commenters’ of HAI data. comply with this request for records suggestions as we continue this process. Response: We do not believe that our within 60-days of receiving notice. The Additionally, as discussed in the proposals place an undue burden on contractor would review these records sections of this rule outlining the facilities. We proposed to request only to ensure accuracy and reliability of the measures, we believe that the ten records, and we will provide the data reported by the facility for specifications, data definitions, and facility 60 days to produce these purposes of the ESRD QIP. reporting requirements are clear and records. We do not believe that As noted above, we proposed that, in transparent. If it becomes apparent that collecting such a small amount of the first year of this program, no facility there is some significant confusion as to documentation in such a great deal of will receive a payment reduction any of these elements, we will clarify time should pose problems for facilities. resulting from the data validation these them using the most appropriate As we explain later in this rule, we process. In future years of the program, means. estimate that it will take each facility we noted our intent to evolve our pilot Comment: One commenter stated that only 2.5 hours to comply with the program into a full, data validation it does not believe it is appropriate for requests for these records and will cost effort. We are also discussing a data CMS to develop a data validation approximately $83.08 per facility. We validation measure whereby facilities measure for the ESRD QIP. This do not believe that 2.5 hours in the span would be scored based on the accuracy commenter argued that CMS must first of 2 months (or 2.5 minutes per day) is of their records. Finally, we are explain the scope of accuracy and errors too little time to comply with these contemplating increasing a facility’s (for example, does it include missing requests nor do we believe it warrants payment reduction by one tier (for values, transcriptional errors) that CMS an additional 60 days for compliance. example, from 0.5 percent to 1.0 requires. Other commenters requested Further, we do not agree that we should percent) if its data are incorrect beyond that, before payment is tied to request a percentage of documents from a certain threshold. In future years, we validation, CMS should publish for facilities rather than a fixed number. If stated our intention to propose more comment the relationship of errors to a facility is large, asking for even one detailed procedures regarding our data payment reductions (with some percent of its records could prove to be validation process that may result in accorded more weight than others a large burden. Alternatively, requesting penalties. We requested comment on depending on their scope and type) and that a small facility provide even 10 our data validation proposals for PY allow the dialysis community to review percent of its records would not provide 2015 and the methods we are the results of the pilot. our data contractor with enough considering for PY 2016. Response: We thank commenters for information to assess the validity of the The comments we received on these these suggestions. We believe that data. By requesting 10 records from each proposals and our responses are set ensuring data accuracy of reported data facility, we can ensure a similar burden forth below. is an important component to ensure (2.5 hours and approximately $83.08) Comment: Many commenters accurate performance scores and for each facility and an analysis of its supported our proposal to have a data corresponding payments. We continue validity based on the same volume of validation pilot program that would to consider whether and how we will tie information. result in no payment reductions. Some payment to any data validation issues. As noted above, at this time, we are commenters suggested that we continue We will publish any future proposals in still finalizing the processes and the pilot until we can evaluate the data rulemaking for public comment. procedures for the pilot. We will from the program, and some Comment: Some commenters provide further information on a commenters suggested that we should expressed concern with the burden data publicly available Web site. As we share the results of the pilot with the validation may place on facilities. One finalize these procedures, we intend to dialysis community before the official commenter is concerned that producing engage various stakeholders to program is launched. One commenter records within 60 days is too monetarily encourage the development of a

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standardized process for the validation scores using the data submitted during information to be made public and the of data, including data from the CDC for the applicable period regardless of procedures for informing the public HAIs. whether the ownership changed during through facility-posted certificates for Comment: One commenter requested one of these periods. If, however, a the first 3 payment years of the ESRD that we specify a data validation appeals facility receives a new CCN as a result QIP (76 FR 636 through 639). We process. of a change in ownership, we would proposed that these requirements Response: We will consider proposing treat the facility as a new facility for generally apply to PY 2015 and a data validation appeals process in purposes of the ESRD QIP as of the date subsequent payment years. However, we future rulemaking. Because the it received the new CCN. We stated our proposed to make some modifications, proposed program is a pilot and will not belief that these proposals are the most as outlined below, to these requirements have any impact on payment, we do not operationally efficient and will allow and that these modifications become believe an appeals process is necessary facilities the most certainty when they effective upon the effective date of this at this time. change ownership. We proposed to final rule. Thus, these requirements, if Comment: One commenter believes apply these rules beginning with the PY finalized, would apply in PY 2014 and that the various technological resources 2014 ESRD QIP, and we requested for subsequent payment years. All other facilities have should be taken into public comment on these proposals. previously finalized requirements account when evaluating data validity. The comments that we received and would remain the same. This commenter encouraged us to our responses to these comments are set First, for the first year of the program, evaluate manual/electronic medical forth below. PY 2012, we did not explicitly state that records (EMR) data entry in Comment: Many commenters strongly we would be publishing a list of facility CROWNWeb. supported our proposals for scoring performance on or after December 1 of Response: We will consider transferred facilities. One commenter the year before the payment commenter’s suggestion when we expressed concern that the proposals consequence year. We did, however, evaluate the data in the pilot program. will change the marketplace in ways make this list available for the pubic via We will specifically consider if there are that are not yet known. the CMS Web site. For the PY 2013 Response: We thank commenters for variations in the accuracy of data ESRD QIP and subsequent payment their support. We realize that this because of the mode of data entry. years, and in accordance with section proposal may impact how dialysis Comment: One commenter 1881(h)(6)(D) of the Act, we proposed to facilities are acquired in the future. encouraged us not to implement a publish such aggregate list on the CMS However, we believe that creating rules payment reduction until all facilities Web site at www.cms.gov and any other around how we will treat transferred have been asked to submit medical Web site controlled by CMS. This list facilities for purposes of the ESRD QIP records for purposes of data validation will include information on the facility, will create a marketplace that is more at least one time. Another commenter specifically: predictable. Therefore, we finalize these stated that each facility should have the (i) Name and address; rules for transferred facilities as opportunity to identify data (ii) Measure rates (which may include proposed. transmission/download errors without numerators and denominators) and the risk of payment penalty. 15. Public Reporting Requirements scores; Response: We thank commenters for (iii) And Total Performance Scores. the suggestions and will consider them Section 1881(h)(6)(A) of the Act as our pilot program advances. requires the Secretary to establish This list will also indicate those For the reasons stated above, we procedures for making information facilities that do not have enough data finalize our pilot data validation regarding facilities’ performance under to calculate one or more measure rates program as proposed, and we will the ESRD QIP available to the public, and/or a Total Performance Score. We specify the processes and procedures of including information on the Total believe it is important to publish such this pilot on http:// Performance Score (as well as a list because it allows beneficiaries, the www.dialysisreports.org. appropriate comparisons of facilities to public, and facilities access to this the national average with respect to information without having to 14. Scoring Facilities Whose Ownership such scores) and performance scores for individually download a certificate for Has Changed individual measures achieved by each each facility, and, because of such During our first year of facility. Section 1881(h)(6)(B) of the Act access, we believe it will ultimately implementation of the ESRD QIP, PY further requires that a facility have an improve quality. The data will be more 2012, facilities requested guidance opportunity to review the information to accessible, Medicare beneficiaries and regarding how a change in ownership be made public with respect to that their families will have the information affects any applicable ESRD QIP facility prior to such information’s more easily to make choices about their payment reduction. We proposed that, publication. In addition, section care, and facilities can more readily for all future years of the ESRD QIP, the 1881(h)(6)(C) of the Act requires the compare their performance to other application of an ESRD QIP payment Secretary to provide each facility with a facilities or across facilities. Therefore, reduction would depend on whether the certificate containing its Total beginning in January 2013, we proposed facility retains its CCN after the Performance Score to post in patient to publish a list of facility information ownership transfer. If the facility’s CCN areas within the facility. Finally, section described above for each payment year remains the same after the facility is 1881(h)(6)(D) of the Act requires the after facilities have the ability to review transferred, for purposes of the ESRD Secretary to post a list of facilities and their scores. QIP, we would consider the facility to performance-score data on the CMS Second, for PY 2012, we required be the same facility (despite the change Web site. facilities to prominently post certificates in ownership) and we would apply any In the PY 2012 ESRD QIP final rule, within 5 days of us making these ESRD QIP payment reduction for the we adopted uniform requirements based certificates available for download from transferor to the transferee. Likewise, as on sections 1881(h)(6)(A) through www.dialysisreports.org in accordance long as the facility retains the same 1881(h)(6)(D) of the Act, establishing with section 1881(h)(6)(C) of the Act (76 CCN, we would calculate the measure procedures for facilities to review the FR 637). We proposed to modify the

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previously finalized requirements for versions of the PSC are not necessary in Additionally, we seek to align the ESRD posting certificates in two ways. We no all locations and recommended that QIP with CMS’ other VBP program; we longer believe it is necessary for individual facility administrators continue to assess how information facilities to post these certificates within determine whether posting a PSC in across programs should be presented, 5 days of their availability. The Spanish is necessary or beneficial based and we will considering creating a ‘‘one- certificates are provided in late upon the population that the facility stop-shop’’ for information related to December, and it was our experience in serves. Another commenter suggested CMS’ programs. At present, a great deal the PY 2012 program that many not only requiring a Spanish PSC but of information on these programs can be individuals responsible for the also developing Spanish-language found here: http://www.cms.gov/ certificates were away on holiday materials explaining the PSCs. Medicare/Quality-Initiatives-Patient- during this period of time. Therefore, Response: We agree with commenters Assessment-Instruments/ we proposed to change this requirement that the burden of posting a Spanish as QualityInitiativesGenInfo/index.html. so that, beginning with the PY 2014 well as an English PSC is very little and Comment: One commenter believes program, facilities will be required to far outweighs the benefits it could that the NHSN measure should be post their certificates on or before the convey upon beneficiaries. We do not included in DFC because it is key to first business day after January 1 of each agree that it is appropriate for facility patient safety. payment year. Certificates are typically administrators to determine whether Response: We thank comments and available for download on or around posting the Spanish PSC is necessary. A will consider the appropriateness for December 15, and we believe that this facility that does not furnish services to inclusion of this measure on DFC in two week amount of time is long enough native Spanish speaking patients in 1 future Web site releases. to allow facilities to post them. year could begin to do so during the Therefore, beginning PY 2014, we next year. As the ESRD QIP evolves, we Comment: One commenter requested proposed that facilities be required to seek to make the program as transparent that we confirm that there is consistency post their Performance Score as possible for all beneficiaries. in measures reported in DFR, DFC, PSR, Certificates (PSCs) on or before the first Comment: Some commenters believe and for ESRD QIP purposes. business day after January 1 of each that the ESRD QIP should be clearer, Response: We thank the commenter payment year in a prominent place for and we should develop and make public for its inquiry regarding the consistency the duration of that payment year and guidance documents for patients and of measures reported through DFR, DFC, otherwise comply with the requirements clinics. These commenters also the Performance Score Reports (PSR), listed in the PY 2012 final rule (76 FR suggested that we hold open door and for ESRD QIP purposes. There are 637). forums specifically for patients so that some differences in the measure Third, for the PY 2012 ESRD QIP, we they do not interpret the quality of care descriptions between DFR, DFC, and required facilities to post one copy of information incorrectly. QIP because each serves its own the certificate in their facility (76 FR Response: As we noted above, we purposes; the measure rates for the 637). Beginning in PY 2014, we seek to make the program as transparent ESRD QIP that are posted on DFR, DFC, proposed to require facilities to post two as possible, specifically to beneficiaries. and in the PSR are the same. For copies of this certificate, one copy in We intend to continue to assess the example, for DFR/DFC, the English and one copy in Spanish. Both modes and efficacy of our denominators for the Kt/V measures of these certificates (which are posted as communications to beneficiaries. We include out of range values, whereas the a single file) will be provided by CMS, will take these comments into account ESRD QIP Kt/V measure denominators both must be posted by the first as we do so. do not. We seek to align reporting business day after January 1 of the Comment: Some commenters mechanisms as much as possible, but, in payment year, and both must be posted requested that we make available on our some cases, we believe that it is for the entirety of such year in a Web site individual measure scores appropriate to present this information prominent location. We proposed to (including the numerator and differently. denominator) and the Total Performance require the certificate to be posted in Comment: One commenter Scores; commenters stated that these both English and Spanish to make the recommended that we timely monitor scores should be organized by facility certificate more understandable to quality data and intervene if trends and state to facilitate choice in care. One native Spanish speakers. Thus, to best indicate a decrease in the quality of commenter requested that this serve a greater number of ESRD patients, care. we proposed to finalize the requirement information be published in both Response: We are committed to that facilities must post both an English English and Spanish. One commenter monitoring and evaluating the impacts and a Spanish certificate prominently in encouraged us to create a ‘‘one-stop- of the ESRD QIP. their facility. The only additional shop’’ for quality information on the burden for facilities in adding this internet. Comment: One commenter urged us Spanish certificate is its printing and Response: Since the PY 2012 program, to prioritize the development and posting. we have made aggregate information on implementation of a single system to The comments we received on these measure scores and Total Performance which facilities would report their data proposals and our responses are set Scores available on http://www.cms.gov/ in order to simplify reporting and forth below. Medicare/End-Stage-Renal-Disease/ minimize unnecessary burdens on Comment: Commenters supported our ESRDQualityImproveInit/index.html. providers, particularly staff members proposal to allow facilities until the first This information includes numerators otherwise providing direct care to business day after January 1 to post and denominators for each clinical patients. certificates. Most commenters agreed measure, the scores for each measure, Response: We continue to evaluate with our proposal to require facilities to and Total Performance Scores for every our reporting systems; we seek to post both English and Spanish versions facility. The information is organized in minimize provider burden as much as of the PSC beginning in PY 2014, stating alphabetical order by state and facility. possible, and we will continue to that the additional burden is very small; We will consider publishing this evaluate ways in which we can do so as one commenter argued that Spanish information in Spanish in future years. the program moves forward.

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IV. Limitation on Payments to All ESRD facilities 100 percent of allowable implementing, with the exception of the Providers, Suppliers and Other Entities bad debt amounts, these payments were proposal to maintain the cap on bad deb Entitled to Bad Debt capped at the facility’s reasonable cost reimbursement for ESRD facilities, as in accordance with § 413.178(a). In the discussed below. A. Background proposed rule, we proposed to maintain Comment: We received comments In accordance with section 1861(v)(1) the cap on bad debt reimbursement to from commenters suggesting that the of the Act and current regulations at 42 an ESRD facility up to the facility’s bad debt reduction percentages be CFR 413.89, Medicare pays some or all unrecovered costs. We also proposed to implemented in single digit percent of the uncollectible deductible and apply the bad debt reduction reductions instead of the double digit coinsurance amounts to those entities percentages mandated by section 3201 percent reductions, as mandated by eligible to receive reimbursement for of the Middle Class Tax Extension and section 3201 of the Middle Class Tax bad debt. To determine if bad debt Job Creation Act of 2012 (Pub. L. No. Extension and Job Creation Act of 2012. amounts are allowable, the requirements 112–96), prior to applying the cap up to Response: While we appreciate the at § 413.89 must be met. Chapter 3 of the the ESRD facility’s unrecovered costs. concerns of the provider community Provider Reimbursement Manual (PRM) regarding bad debt payments to (CMS Pub. 15, Part I) provides B. Section 3201 of The Middle Class Tax providers eligible to receive bad debt, additional guidance on the standards Extension and Job Creation Act of 2012 the percent reductions of bad debt governing bad debt reimbursement. (Pub. L. 112–96) payments are statutorily mandated by Prior to the passage of the Middle Sections 3201(a) and (b) of the Middle section 3201 of the Middle Class Tax Class Tax Extension and Job Creation Class Tax Extension and Job Creation Extension and Job Creation Act of 2012 Act of 2012 (Pub. L. 112–96), under Act of 2012 (Pub. L. 112–96) amended and do not provide for discretion. section 1861(v)(1)(T) of the Act and section 1861(v)(1)(T) and section Therefore, we are codifying these § 413.89(h)(1) of our regulations, 1861(v)(1)(V) of the Act, respectively, by provisions, as summarized below, in our Medicare payments for allowable bad further reducing the percentage of regulations. debt amounts for hospitals were allowable bad debt attributable to the • Payment of allowable bad debt to reduced by 30 percent for cost reporting deductibles and coinsurance amounts hospitals for cost reporting periods periods beginning on or after October 1, payable to hospitals (section beginning during fiscal year 2013 and 2001. Likewise, under section 1861(v)(1)(T)) and SNFs (section subsequent fiscal years will be reduced 1861(v)(1)(V) of the Act and 1861(v)(1)(V)). Section 3201(b) of Public by 35 percent. § 413.89(h)(2) of our regulations, Law 112–96 also revised the SNF bad • Payment of allowable bad debt to Medicare payments for allowable bad debt reductions to include both dual SNFs and swing bed hospitals for cost debt amounts for patients in skilled eligible beneficiaries and non-dual reporting periods beginning during nursing facilities (SNFs) that were not eligible beneficiaries under section fiscal year 2013 or a subsequent fiscal dual eligible individuals beginning with 1861(v)(1)(V) of the Act, and to apply year will be reduced by 35 percent for cost reporting periods beginning on or such reductions to swing bed hospitals coinsurance amounts for services after October 1, 2005, were reduced by for cost reporting periods beginning furnished to a beneficiary who is not a 30 percent. Section 413.89(h)(2) defines during fiscal year 2013 and subsequent dual eligible individual. a dual eligible individual for bad debt fiscal years. • Payment of allowable bad debt to purposes as an individual that is Finally, section 3201(c) of The Middle SNFs and swing bed hospitals for entitled to benefits under Part A of Class Tax Extension and Job Creation coinsurance for services furnished to a Medicare and is determined eligible by Act of 2012 added a new subparagraph beneficiary who is a dual eligible the State for Medical Assistance under 1861(v)(1)(W) to the Act, which applied individual will be: Title XIX of the Act as described in 42 a reduction in bad debt payments to • For cost reporting periods CFR 423.772 paragraph (2) under the ‘‘providers’’ not addressed under beginning during fiscal year 2013, definition of a ‘‘full-benefit dual eligible subparagraphs 1861(v)(1)(T) or reduced by 12 percent; individual.’’ • 1861(v)(1)(V) of the Act. For the purpose For cost reporting periods For all other providers, suppliers, and beginning during fiscal year 2014, entities eligible to receive bad debt of subparagraph 1861(v)(1)(W) of the Act, section 3201(c) Public Law 112–96 reduced by 24 percent and; payment, including critical access • For cost reporting periods hospitals (CAHs), rural health clinics defined ‘‘providers’’ as those providers not previously described in subsections beginning during fiscal year 2015, (RHCs), Federally qualified health reduced by 35 percent. centers (FQHCs), community mental 3201(a) or (b), suppliers, or any other • type of entity that receives payment for Payment of allowable bad debt to health centers (CMHCs), end stage renal all other providers, suppliers and any diease (ESRD) facilities, swing bed bad debts under the authority of section 1861(v)(1)(A) of the Act. These other entity that receives payment for hospitals, as defined at 42 CFR bad debts under the authority of section 413.114(b), and patients that are dual providers include, but are not limited to, CAHs, RHCs, FQHCs, CMHCs, HMOs 1861(v)(1)(A) of the Act will be: eligible individuals in SNFs, Medicare • For cost reporting periods reimbursed on a cost basis, CMPs, paid 100 percent of allowable bad debt beginning during fiscal year 2013, HCPPs and ESRD facilities. amounts. Additionally, for health reduced by 12 percent; maintenance organizations (HMOs) C. Summary of Provisions of This Final • For cost reporting periods reimbursed on a cost basis and Rule beginning during fiscal year 2014, competitive medical plans (CMPs) reduced by 24 percent; defined under section 1876 of the Act, 1. Self-Implementing Provisions of • And for cost reporting periods and for health care prepayment plans Section 3201 Public Law 112–96 beginning during fiscal year 2015 and (HCPPs) defined under section The provisions of subsections 3201(a), subsequent fiscal years, by 35 percent. 1833(a)(1)(A) of the Act, Medicare pays (b), and (c) of The Middle Class Tax A summary of the changes in a portion of bad debt amounts under 42 Extension and Job Creation Act of 2012 Medicare bad debt payment percentages CFR 417.536(f) of our regulations. permit no discretion on the part of the required by section 3201 of The Middle Although Medicare previously paid Secretary and thus, are self Class Tax Extension and Job Creation

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Act of 2012 is reflected in Table 8 below:

TABLE 8—SUMMARY OF MEDICARE BAD DEBT REIMBURSEMENT BY PROVIDER TYPES FOR COST REPORTING PERIODS THAT BEGIN DURING FY 2013, 2014, 2015 AND SUBSEQUENT YEARS

Allowable bad Allowable bad Allowable bad Allowable bad debt amount Provider type debt amount debt amount debt amount during FY 2015 & during FY 2012 during FY 2013 during FY 2014 subsequent FYs (percent) (percent) (percent) (percent)

Hospitals ...... 70 65 65 65 SNFs: Non-Full Dual Eligibles ...... 70 65 65 65 Swing Bed Hospitals: Non-Full Dual Eligibles ...... 100 65 65 65 SNFs: Full Dual Eligibles ...... 100 88 76 65 Hospital Swing Beds: Full Dual Eligibles ...... 100 88 76 65 CAHs ...... 100 88 76 65 ESRD Facilities ...... 100 88 76 65 CMHCs ...... 100 88 76 65 FQHCs ...... 100 88 76 65 RHCs ...... 100 88 76 65 Cost Based HMOs ...... 100 88 76 65 Health Care Pre-Payment Plans ...... 100 88 76 65 Competitive Medical Health Plans ...... 100 88 76 65

2. ESRD Bad Debt Cap and Remove and reimbursement to ESRD facilities will payments until January 1, 2013 and the Reserve § 413.178 allow ESRD facilities to claim bad debts ESRD bad debt reduction effective In the proposed rule, we proposed to at an amount exceeding unrecovered October 1, 2012: maintain the cap on bad debt costs incurred under a prospective Example (A), for cost reporting periods reimbursement up to an ESRD facility’s payment system. In addition, removal of beginning before October 1, 2012, only the unrecovered costs. Bad debt payments the cap on bad debt reimbursement to cap applies as follows: are made under section 1861(v)(1)(A) of ESRD facilities complies with the order 1. Unrecovered costs = $100.00 of the D.C. Circuit Court in Kidney 2. Aggregate Gross bad debt = $110.00 the Act to prevent non-Medicare 3. Bad debt amount of $110.00 is capped patients from subsidizing Medicare Center of Hollywood, et al. v. Shalala, 133 F.3d 78 (D.C. Circuit 1998), and will at the unrecovered costs of $100.00, patients and vice-versa, also known as therefore, the facility receives $100.00. the anti-cross subsidization principle. allow us to apply our bad debt policies consistently across all the types of Example (B), for cost reporting periods The cap at an ESRD facility’s beginning between October 1, 2012 and unrecovered costs for bad debt providers eligible to receive bad debt payments. Therefore, we believe the December 31, 2012, the 12 percent reduction reimbursement was originally applies up to the facilities’ unrecovered costs implemented to assure that the removal of the bad debt reimbursement as follows: combination of the composite rate cap at an ESRD facility’s unrecovered 1. Unrecovered costs = $100.00 payment and the bad debt payment did cost, is an equitable and reasonable 2. Aggregate Gross bad debt = $110.00 not exceed the ESRD facility’s total policy choice with respect to bad debt 3. Bad debt amount of $110.00 is reduced allowable costs of providing services to reimbursement to ESRD facilities. by 12 percent (bad debt reduction in FY Medicare beneficiaries, as well as to We are eliminating the cap for ESRD 2013) which equals $96.80. Since the reduction is less than the cap, the facility avoid violating the anti-cross facilities for cost reporting periods receives $96.80. subsidization principle. Thus, by beginning on or after January 1, 2013, applying the cap, an ESRD facility the effective date of this final rule. With Example (C), for cost reporting periods would not be paid for bad debt amounts this change, ESRD facilities will be beginning on or after January 1, 2013 and before October 1, 2013, only the 12 percent that exceeded its unrecovered costs reimbursed for bad debt reduced as reduction applies: under the composite rate payment outlined in the proposed changes to 1. Unrecovered costs = $100.00 system implemented in 1983. § 413.89(h)(3), described above. 2. Aggregate Gross bad debt = $110.00 Comment: We received comments However, because the new bad debt 3. The $110.00 bad debt amount is reduced from commenters suggesting the reductions for ESRD facilities become by 12 percent (bad debt reduction in FY maintenance of the cap on bad debt effective October 1, 2012, and the 2013). The facility receives $96.80 with no reimbursement to ESRD facilities up to removal of the cap on bad debt cap applied. the facilities’ unrecovered costs was reimbursement to ESRD facilities will We are moving current regulations inconsistent with the bad debt not be effective until January 1, 2013, text at § 413.178(a) to proposed reimbursement policies for all other for cost reporting periods beginning § 413.89(h)(3). The revised regulation types of providers eligible to receive bad between October 1, 2012 and December text will remove the bad debt cap for debt reimbursement and was also 31, 2012, the cap on bad debt ESRD facilities, and include the bad inconsistent with Federal court rulings. reimbursement to ESRD facilities will be debt reduction percentages applicable to Response: After careful consideration calculated with both the required bad ESRD facilities in accordance with of the policy implications of removing debt reductions and the cap on bad debt 1861(v)(1)(W). the cap on bad debt reimbursement at reimbursement to ESRD facilities. For We are removing current paragraphs an ESRD facility’s unrecovered costs, we illustrative purposes only, the following (b), (c), and (d)(1) of § 413.178 since have decided to eliminate the cap. The examples present the interaction of the these provisions already are set out at elimination of the cap on bad debt application of the cap on ESRD bad debt § 413.89, Chapter 3 of the PRM Part I,

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and in the Medicare cost report 1861(v)(1)(T)(v) of the Act to hospitals Medicare cost report instructions in the instructions in the PRM Part II. for cost reporting periods beginning PRM Part II. We are moving the current In addition, we are moving the bad during fiscal year 2013 and subsequent general bad debt exception at § 413.89(i) debt exception provision applicable to fiscal years. to new paragraph § 413.89(i)(1) in order ESRD facilities discussed at We are revising § 413.89(h)(2) to add to move the ESRD facilities’ bad debt § 413.178(d)(2) to proposed paragraphs (h)(2)(i) and (h)(2)(ii). exception provision previously § 413.89(i)(2). For consistency, we are Paragraph (h)(2)(i) will set forth the discussed at § 413.178(d)(2) to new also moving the current general bad percentage reduction in reimbursable paragraph § 413.89(i)(2). debt exception set out at § 413.89(i) to bad debt payments required by section 3. Technical Corrections to 42 CFR new paragraph § 413.89(i)(1). 1861(v)(1)(V)(ii) of the Act for SNFs and 417.536(f)(1) We are removing and reserving swing bed hospitals for cost reporting § 413.178. periods beginning during fiscal years In this final rule, we are revising the 2006 through 2012 for a patient that was regulations text at 417.536(f)(1) to 3. Technical Corrections not a dual eligible individual. Paragraph correct the cross-reference to the We are making a technical correction (h)(2)(ii) will set forth the reduction in Medicare bad debt reimbursement to 42 CFR 417.536(f)(1) to refer to 42 reimbursable bad debt payments for regulation, so that § 417.536(f)(1) will CFR 413.89 as the appropriate cross SNFs and swing bed hospitals, for cost reference 42 CFR 413.89 instead of the reference to Medicare bad debt reporting periods beginning during outdated reference to § 413.80. In reimbursement policy, to revise the fiscal year 2013 and subsequent fiscal addition, we are revising the language at existing language describing bad debt to years, for a patient that was a dual 42 CFR 417.536(f)(1) to conform to the conform to § 413.89(a), and to remove eligible individual. description of bad debt in § 413.89(a) requirements that already are set out at We are revising § 413.89(h)(3) to set and we are removing § 417.536(f)(1)(i) § 413.89. forth the percentage reduction in and (ii) since these provisions already allowable bad debt payments required are set out at § 413.89, in Chapter 3 of D. Changes to Medicare Bad Debt Policy by section 1861(v)(1)(W) of the Act for the PRM Part I, and in the Medicare cost In this rule, we are conforming ESRD facilities for cost reporting report instructions in the PRM Part II. existing regulations text found at periods beginning during fiscal year V. Collection of Information § 413.89(h) to the self-implementing 2013, fiscal year 2014 and subsequent Requirements provisions of section 3201 of Public Law fiscal years. We are also revising 112–96. Previously, bad debt § 413.89(h)(3) to set forth the A. Legislative Requirement for reimbursement to an ESRD facility was applicability of the cap on bad debt Solicitation of Comments capped up to the facility’s reasonable reimbursement to ESRD facilities for Under the Paperwork Reduction Act costs under § 413.178(a). In this final cost reporting periods beginning of 1995, we are required to provide 30- rule, we are moving the current between October 1, 2012 and December day notice in the Federal Register and provision at § 413.178(a) to 31, 2012. solicit public comment before a § 413.89(h)(3), and adding ESRD We are adding a new § 413.89(h)(4) to collection of information requirement is facilities to the list of facilities to which set forth the percentage reduction in submitted to the Office of Management § 413.89 ‘‘Bad debts, charity, and reimbursable bad debt payments for all and Budget (OMB) for review and courtesy allowances,’’ applies. We are other entities required by section approval. In order to fairly evaluate also eliminating duplicate provisions in 1861(v)(1)(W) of the Act not described whether an information collection § 413.178 and reserving § 413.178 for in § 413.89(h)(1), (h)(2), or (h)(3) that are should be approved by OMB, section future use. In addition, we are making eligible to receive reimbursement of bad 3506(c)(2)(A) of the Paperwork a technical correction to § 417.536(f)(1) debt for cost reporting periods Reduction Act of 1995 requires that we to clarify Medicare bad debt beginning during fiscal year 2013, fiscal solicit comment on the following issues: reimbursement policy. year 2014, and subsequent fiscal years. • The need for the information 1. Changes to 42 CFR 413.89(h) 2. Rationale for Removing 42 CFR collection and its usefulness in carrying 413.178 out the proper functions of our agency. Under each paragraph of our existing • The accuracy of our estimate of the regulations at § 413.89(h), we describe Previously, § 413.178(a) stated that information collection burden. the limits on bad debt payment to be CMS will reimburse each ESRD facility • The quality, utility, and clarity of reductions to the amount of bad debt its allowable Medicare bad debts, as the information to be collected. otherwise treated as allowable costs. defined in § 413.89(b), up to the • Recommendations to minimize the Under § 413.89(a), bad debts are facility’s costs, as determined under information collection burden on the deductions from revenue and are not to Medicare principles, in a single lump affected public, including automated be included in allowable cost. sum payment at the end of the facility’s collection techniques. Therefore, we are clarifying that the cost reporting period. This cap on bad limits on bad debt payments are debt reimbursements will be eliminated B. Requirements in Regulation Text reductions to amount of allowable bad and the new reductions in bad debt We did not propose and therefore are debt. reimbursements will be applied, as not finalizing any changes to regulatory We are revising § 413.89(h)(1)(iv) to discussed above. text for the ESRD PPS in CY 2013. set forth the percentage reduction in We are revising § 413.89(h)(3) to reimbursable bad debt payments to implement the ESRD facilities’ bad debt C. Additional Information Collection hospitals for cost reporting periods reduction effective October 1, 2012 in Requirements beginning during fiscal years 2001 accordance with section 1861(v)(1)(W) This final rule does not impose any through 2012. of the Act. new information collection We are adding a new § 413.89(h)(1)(v), We are also removing and reserving requirements in the regulation text, as which will set forth the percentage § 413.178, since the revised provisions specified above. However, this final rule reduction in reimbursable bad debt already are set out at § 413.89, in does make reference to several payments required by section Chapter 3 of the PRM Part I, and in the associated information collections that

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are not discussed in the regulation text $33.23.9 Since we anticipate nurses (or 5,525 facilities × 12 mohths) for the PY contained in this document. The administrative staff) will post these 201 ESRD QIP performance period. We following is a discussion of these certificates, we estimate that the estimae it will require 10 minutes to information collections. We are aggregate cost of this requirement will collect and submit data on these events, soliciting public comment on each of be $31,701 ($33.23/hour × 954 hours). and the estimated burden for submiting these issues. We estimate that approximately one- 12 mohths of data will be 66,300 hours third of ESRD patients, or 100,000 × 1. ESRD QIP (397,800 dialysis events 10/60 patients, will ask a question about the minute). If the dialysis events were a. Display of Certificates for the PY 2015 ESRD QIP certificate. We further distributed evenly across all 5,525 ESRD QIP estimate that it will take each facility facilities, the reporting would result in Section III.D.15 of this final rule approximately 5 minutes to answer each an additional 12 hour (66, 300 hours/ discusses a disclosure requirement for patient’s question about the applicable 5,525 facilities), burden for each facility the PY 2014 and PY 2015 ESRD QIP. As ESRD QIP certificate, or 1.52 hours per at a cost of $399 ($33.23/hour × 12 stated earlier in this final rule, section facility each year. The total estimated hours) per facility. Again, we estimate 1881(h)(6)(C) of the Act requires the annual burden associated with this the mean hourly wage of a registered requirement is 8,704 hours (1.52 hours/ nurse is $33.23, and we anticipate Secretary to provide certificates to × dialysis care providers and facilities facility 5,726 facilities). The total nurses (for administrative staff) will be with their Total Performance Scores estimated annual burden for both responsible for this reporting. In total, under the ESRD QIP. This section also displaying the ESRD QIP certificates we believe that the cost for all ESRD and answering patients’ questions about requires each facility that receives an facilities to comply with the reporting the certificates is 9,658 hours (8,704 ESRD QIP certificate to display it requirements associated with NHSN hours + 954 hours). While the total prominently at the facility. Dialysis Event reporting measure will be estimated annual burden associated To comply with this requirement, we approximately $2.2 million ($399 × with both of these requirements as proposed to issue one English and one 5,525 facilities= $2,204,475) per year. discussed is 9,658 hours, we do not Spanish ESRD QIP certificate beginning believe that there will be a significant in PY 2014 to facilities via a generally c. ICH CAHPS Survey Attestation cost associated with these requirements accessible electronic file format. We had Requirement for the PY 2015 ESRD QIP because we are not requiring facilities to previously finalized other display complete new forms. We estimate that As stated above in section III.D.1.c of requirements for the program, including the total cost for all ESRD facilities to this final rule, we finalized a measure that each facility prominently display comply with the collection of that assesses facility usage of the ICH the applicable ESRD QIP certificate in information requirements associated CAHPS survey as a reporting measure the patient area, take the necessary with the certificates each year would be for the PY 2015 ESRD QIP. The burden measures to ensure the security of the less than $320,935 ($33.23/hour × 9,658 associated with this requirement is the certificate in the patient areas, and have hours). time and effort necessary for facilities to staff available to answer questions about administer the ICH CAHPS survey b. NHSN Dialysis Event Reporting the certificate in an understandable through a third party and submit an Requirement for the PY 2015 ESRD QIP manner, taking into account that some attestation to CMS that they successfully patients might have limited English As stated above in section III.D.2.a of administered the survey. proficiency. this finalrule, we finalized a measure We estimate that approximately 5,523 The burden associated with the requiring facilities to reporting dialysis facilities treat adult, in-center aforementioned requirements is the time events to the NHSN for he PY 2015 and effort necessary for facilities to print ESRD QIP. Specifically, we will require hemodialysis patients and are, therefore, the applicable ESRD QIP certificates, facilities to submit 12 months of dialysis eligible to receive a score on this display the certificates prominently in event data to the NHSN to receive 10 measure. We estimate that all 5,523 patient areas, ensure the safety of the points on the measure. The burden facilities will administer the ICH certificates, and respond to patient associated with this requirement for CAHPS survey through a third-party inquiries in reference to the certificates. existing facilities is the time and effort and submit an attestation to that effect. We do not anticipate that posting the necessary for facilities to submit 12 We estimate that it will take each Spanish certificate will add more time months of data in order to receive the facility’s third-party administrator 16 or burden to the Collection of maximum number of points. According hours per year to be trained on the Information requirements outlined in to our most recent data, 5,525 facilities survey features. We further estimate that the CY 2011 ESRD PPS final rule (76 FR treat adult in-center hemodialysis and/ it will take each facility approximately 70298 through 70299) for the PY 2014 or pediatric in-center hemodialysis 5 minutes to submit the attestation each ESRD QIP. Therefore, this analysis only patients and are, then, eligible to receive year. The estimated total annual burden applies to the burden associated with a score on this measure; therefore, we on facilities is 88,829 hours ((16 hours × × the PY 2015 and beyond requirements. estimate that approximately 5,525 5,523 facilities) + ((5/60 minutes) We estimate that approximately 5,726 facilities will submit the required data. 5,523 facilities) which is equal to × facilities will receive ESRD QIP Based on data previously collected, we $2,952,818 (88,829 hours $33.23), or certificates in PY 2015 and will be further estimate that the average number $534 per facility ($2,952, 818/5,523). required to display them. We also of dialysis events is 0.008 per patient Again, we estimate the mean hourly estimate that it will take each facility 10 per month and that each facility has wage of a registered nurse is $33.23, and minutes per year to print, prominently approximately 75 patients. Accordingly, we anticipate nurses (or administrative display, and secure the ESRD QIP we estimate the number of dialysis staff) will be responsible for this certificates, for a total estimated annual events in a 12-month period for all reporting. We estimate that it would burden of 954 hours (10/60 hours facilities to be 397,800 (0.09 events/ take each patient 30 minutes to *5,726 facilities). According to the patient/month × 75 patiens/facility × complete the survey (to account for Bureau of Labor Statistics, the mean variability in education levels) and that hourly wage of a registered nurse is 9 This hourly wage is absent any fringe benefits. approximately 75 surveys per year

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would be taken per facility.10 CAHPS burden analysis is incorrect. VI. Economic Analyses Interviewers from each facility would This commenter stated that if the A. Regulatory Impact Analysis spend a total of approximately 37.5 average facility serves 75 patients, it hours per year with patients completing would survey at most 75 patients per 1. Introduction these surveys (30/60 minutes * 75 year. We examined the impacts of this final × Response: We believe that this minutes) or $1,247 (37.5 hours $33.23) rule as required by Executive Order assumption is a good approximation for for an estimated annual burden of 12866 (September 30, 1993, Regulatory this analysis. We realize that facilities 207,113 hours (37.5 hours * 5,523 Planning and Review) and Executive may have more than 75 patients or less facilities) which is equal to $6.9 million Order 13563 on Improving Regulation × than 75 patients. Across the ESRD (207,113 hours 33.23/hour). We and Regulatory Review (January 18, population, however, we believe 75 estimate that time burden for ESRD 2011). Executive Orders 12866 and patients per facility is accurate. facilities to comply with the collection 13563 direct agencies to assess all costs of information requirements associated According to the ICH CAHPS specifications, if a facility has less than and benefits of available regulatory with administering the ICH CAHPS alternatives and, if regulation is survey each year would be 200 patients, it must draw a census of patients from this facility. Therefore, if necessary, to select regulatory approximately $1,781 ($534 + $1,247) approaches that maximize net benefits for each facility, or $9.9 million ($1,781 the average facility has 75 patients, we × believe it would survey at most 75 (including potential economic, 5,523 facilities =$9,836,463) across all environmental, public health and safety ESRD facilities. patients. Comment: One commenter expressed effects, distributive impacts, and d. Data Validation Requirements concern that responding to questions equity). Executive Order 13563 emphasizes the importance of Section III.D.13 of this final rule from patients about the Performance quantifying both costs and benefits, of outlines the data validation processes Score Certificates (PSCs) could consume reducing costs, of harmonizing rules, we are finalizing. We will randomly too many staff hours. and of promoting flexibility. This rule sample records from 750 facilities; each Response: We recognize that patients has been designated economically sampled facility would be required to may have questions about the PSCs. The significant under section 3(f)(1) of produce approximately 10 records. The ESRD QIP is designed not only to Executive Order 12866. Accordingly, burden associated with this validation incentivize care, but also to stimulate the rule has been reviewed by the Office requirement is the time and effort discussion about the quality of dialysis of Management and Budget. We have necessary to submit validation data to a care. Therefore, we believe that these prepared a Regulatory Impact Analysis CMS contractor. Because we anticipate questions and answers are important in that to the best of our ability presents that the sampled facilities will be promoting the goals of the program and the costs and benefits of the final rule. reimbursed by our validation contractor improvement in care in that they for the costs associated with copying promote patient awareness and 2. Statement of Need understanding of the care they are and mailing the requested records, we This rule finalizes a number of only estimate the burden of retrieving receiving. Additionally, we believe that these questions will be answered during routine updates for renal dialysis items and submitting the necessary records. and services in CY 2013, implements We estimate that it will take each the course of usual patient care. We will continue to monitor the burden these the third year of the ESRD PPS facility approximately 2.5 hours to transition, and makes several policy comply with these requirements. If 750 questions may place upon facilities. To obtain copies of the supporting changes and clarifications to the ESRD facilities are tasked with providing the PPS. These include updates and required documentation, the estimated statement and any related forms for the paperwork collections referenced above, changes to the ESRD PPS and composite annual burden across all facilities will rate base rates, wage index values, wage be 1,875 hours (750 facilities × 2.5 access CMS’ Web site at http:// www.cms.gov/PaperworkReductionAct index budget-neutrality adjustment hours) at a total of $62,307 (1,875 hours factors, outlier payment policy, and × $33.23/hour) or $83.08 ($62,307/750) of1995/PRAL/list.asp#TopOfPage. If you comment on these information transition budget-neutrality adjustment. per facility in the sample. Again, we collection and recordkeeping Failure to publish this final rule would estimate the mean hourly wage of a requirements, please submit your result in ESRD facilities not receiving registered nurse is $33.23, and we comments to the Office of Information appropriate payments in CY 2013. anticipate nurses (or administrative and Regulatory Affairs, Office of This final rule also implements the staff) will be responsible for providing Management and Budget, Attention: QIP for PY 2015 and beyond by this information. CMS Desk Officer, [CMS–1352–F]; Fax: establishing measures, a scoring system, The comments we received on this (202) 395–6974; or Email: and payment reductions to incentivize analysis are set forth below. [email protected]. improvements in dialysis care as Comment: One commenter believes directed by section 1881(h) of the Act. that the underlying premise for the 2. Reductions to Bad Debt Payments for Failure to establish QIP program All Medicare Providers parameters in this rule would prevent 10 Last year, we stated that we believed that 200 surveys would be administered per facility per year The statutorily mandated reductions continuation of the QIP beyond PY (76 FR 70299). Upon further review, however, we of bad debt payments to providers, 2014. note that the ICH CAHPS specifications require a suppliers, and other entities that are This final rule also implements the sample of 200 surveys only for those facilities with currently receiving bad debt payments reduction percentages of bad debt a large patient population. Faculties with fewer reimbursement required by section 3201 than 200 patients are required to survey all patients, will not result in any changes to or any aiming for a 40 percent response rate. (http:// additional collection of information of The Middle Class Tax Extension and www.cahps.ahrq.gov/∼/media/Files/ requirements. The removal of the cap on Job Creation Act of 2012. This final rule SurveyDocuments/ICH/Admin_Survey/ bad debt reimbursement to ESRD also removes the cap on bad debt _ _ _ _ 53 fielding the ich survey.pdf). Since we estimate facilities will result in fewer collection reimbursement to an ESRD facility up to that each facility serves approximately 75 patients, we believe that the average facility, at most, would of information requirements for ESRD the facility’s unrecovered costs. Section survey 75 patients per year. facilities. 3201(c) of The Middle Class Tax

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Extension and Job Creation Act of 2012 Medicare program History file as a basis for Medicare adds a new subparagraph— Fiscal year savings from dialysis treatments and payments under 1861(v)(1)(W) to the Act and applies a reductions in bad the ESRD PPS. We updated the 2011 debt reduction in bad debt payments to claims to 2012 and 2013 using various ‘‘providers’’ not addressed under 2013 ...... 240 million. updates. The updates to the ESRD PPS subparagraphs 1861(v)(1)(T) or 2014 ...... 600 million. base rate and the base composite rate 1861(v)(1)(V) of the Act. For the purpose 2015 ...... 900 million. portion of the blended rate during the of subparagraph 1861(v)(1)(W) of the 2016 ...... 1.06 billion. transition are described in section II.C of Act, section 3201(c) of The Middle Class 2017 ...... 1.14 billion. this final rule. In addition, in order to 2018 ...... 1.21 billion. Tax Extension and Job Creation Act of 2019 ...... 1.30 billion. prepare an impact analysis, since some 2012 defined ‘‘providers’’ as a supplier 2020 ...... 1.39 billion. ESRD facilities opted to be paid the or any other type of entity that receives 2021 ...... 1.49 billion. blended payment amount during the payment for bad debts under the 2022 ...... 1.59 billion. transition, we made various authority of section 1861(v)(1)(A) of the assumptions about price growth for the Act. These providers include, but are Aggregate FY Total 10.92 billion. formerly separately billable drugs and Savings. not limited to, CAHs, RHCs, FQHCs, laboratory tests with regard to the CMHCs, HMOs reimbursed on a cost Additionally, in section IV of this composite portion of the ESRD PPS basis, CMPs, HCPPs and ESRD facilities. final rule, we discuss the removal of the blended payment during the transition. These rates of price growth are briefly 3. Overall Impact cap on bad debt reimbursement to ESRD facilities. We estimate the removal of outlined below, and are described in We estimate that the final revisions to this cap will result in a cost to the more detail in the CY 2011 ESRD PPS the ESRD PPS will result in an increase Medicare program in the amount of final rule (75 FR 49078 through 49080). of approximately $250 million in $170 million from 2013 through 2022. We used the CY 2011 amounts for the payments, from Medicare, to ESRD CYs 2012 and 2013 amounts for facilities in CY 2013, which includes Medicare program Fiscal year cost resulting from Supplies and Other Services, since this the amount associated with the increase cap removal category primarily includes the $0.50 in the ESRDB market basket reduced by administration fee for separately billable the productivity adjustment, updates to 2013 ...... 10 million. Part B drugs and this fee continues to be outlier amounts, and the effect of 2014 ...... 20 million. an appropriate amount. Because some changing the blended payments from 50 2015 ...... 10 million. ESRD facilities will receive blended 2016 ...... 10 million. percent under the composite rate 2017 ...... 20 million. payments during the transition and payment and 50 percent under the 2018 ...... 20 million. receive payment for ESRD drugs and ESRD PPS to 25 percent under the 2019 ...... 20 million. biologicals based on their average sales composite rate payment and 75 percent 2020 ...... 20 million. price plus 6 percent (ASP+6), we under the ESRD PPS. 2021 ...... 20 million. estimated price growth for these drugs 2022 ...... 20 million. We estimate that the requirements and biologicals based on ASP+6 related to the ESRD QIP for PY 2015 Aggregate FY Total 170 million. percent. We updated the last available will cost approximately $12.4 million Cost. quarter of actual ASP data for the top and the predicted payment reductions twelve drugs (the fourth quarter of 2012) will equal about $12.1 million to result B. Detailed Economic Analysis thru 2013 by using the quarterly growth in a total impact from the proposed in the Producer Price Index (PPI) for 1. CY 2013 End-Stage Renal Disease Drugs, consistent with the method for ESRD QIP requirements of $24.6 (ESRD) Prospective Payment System million. addressing price growth in the ESRDB (PPS) market basket. This resulted in increases In section IV of this final rule, we a. Effects on ESRD Facilities of 3.0 percent, 0.2 percent, 1.4 percent discuss the provisions required by To understand the impact of the and 1.0 percent, respectively, for the section 3201 of The Middle Class Tax first quarter of 2013 thru the fourth Extension and Job Creation Act of 2012, changes affecting payments to different categories of ESRD facilities, it is quarter of 2013. Since the top twelve which apply percentage reductions in drugs account for over 99 percent of bad debt reimbursement to all providers necessary to compare estimated payments (that is, payments made under total former separately billable Part B eligible to receive bad debt the 100 percent ESRD PPS and those drug payments, we used a weighted reimbursement; these provisions are under the ESRD PPS blended payment average growth of the top twelve drugs specifically prescribed by statute and during the transition) in CY 2012 to for the remainder. Table 8 below shows thus, are self-implementing. Table 9 in estimated payments in CY 2013. To the updates used for the drugs. section IV.C.1 of the CY 2013 proposed estimate the impact among various rule (77 FR 40988) depicts a comparison We updated payments for laboratory classes of ESRD facilities, it is tests paid under the laboratory fee of the bad debt payment percentages imperative that the estimates of schedule to 2012 and 2013 using the prior to and after FY 2013. We estimate payments in CY 2012 and CY 2013 statutorily required update of the CPI– these self implementing provisions of contain similar inputs. Therefore, we section 3201 of The Middle Class Tax simulated payments only for those U increase with any legislative Extension and Job Creation Act of 2012 ESRD facilities for which we are able to adjustments. For this final rule, the will result in savings to the Medicare calculate both current payments and growth from 2011 to 2012 is 0.7 percent program of $10.92 billion over the new payments. and the growth from 2011 to 2013 is ¥ period from 2012 through 2022. For this final rule, we used the June 1.1 percent. 2012 update of CY 2011 National Claims

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TABLE 9—PRICE INCREASES FROM 2011 TO 2012 AND 2011 TO 2013 OF FORMER SEPARATELY BILLABLE PART B DRUGS

Total growth 2011 to Total growth 2011 to Separately billable drugs 2012 2013 (percent) (percent)

EPO ...... ¥0.3 5.0 Paricalcitol ...... ¥31.6 ¥36.5 Sodium_ferric_glut ...... ¥24.8 ¥33.3 Iron_sucrose ...... ¥14.7 ¥14.2 Levocarnitine ...... 12.2 ¥2.3 Doxercalciferol ...... ¥68.3 ¥68.5 Calcitriol ...... 64.6 15.7 Vancomycin ...... ¥12.4 ¥15.4 Alteplase ...... 15.5 24.4 Aranesp ...... 6.5 12.3 Daptomycin ...... 11.5 19.0 Ferumoxytol ...... ¥7.8 ¥4.3 Weight for others ...... ¥8.1 ¥4.6

Table 10 below shows the impact of compared to estimated payments to the estimated CY 2013 ESRD payments ESRD facilities in CY 2012.

TABLE 10—IMPACT OF CHANGES IN PAYMENTS TO ESRD FACILITIES FOR THE CY 2013 ESRD FINAL RULE [Percent change in total payments to ESRD facilities (both program and beneficiaries)]

A B C D E Effect of 2013 Effect of 2013 Effect of total Number of changes in 2013 Number of treatments changes in facilities outlier policy 3 wage indexes changes 4 (in millions) (percent) (percent) (percent)

Facility type

All Facilities ...... 5,726 41.4 0.4 0.0 3.0 Type Freestanding ...... 5,176 38.0 0.5 0.0 2.9 Hospital based ...... 550 3.4 0.3 0.1 3.6 Ownership Type Large dialysis organization ...... 3,719 27.3 0.5 0.0 2.9 Regional chain ...... 926 7.1 0.3 0.1 3.0 Independent ...... 636 4.4 0.2 0.0 3.0 Hospital based 1 ...... 434 2.6 0.3 0.2 3.6 Unknown ...... 11 0.0 0.3 1.5 4.4 Geographic Location Rural ...... 1,267 6.8 0.5 ¥0.2 2.9 Urban ...... 4,459 34.6 0.4 0.0 3.0 Census Region East North Central ...... 941 6.3 0.5 0.1 3.1 East South Central ...... 472 3.1 0.6 ¥0.5 2.5 Middle Atlantic ...... 641 5.1 0.4 0.0 3.1 Mountain ...... 335 1.9 0.3 ¥0.3 2.6 New England ...... 171 1.4 0.5 0.5 3.5 Pacific ...... 667 5.6 0.2 0.6 3.4 Puerto Rico and Virgin Islands ...... 41 0.3 0.2 ¥2.4 0.6 South Atlantic ...... 1,259 9.5 0.6 ¥0.2 2.8 West North Central ...... 416 2.2 0.4 0.1 3.2 West South Central ...... 783 6.0 0.5 ¥0.2 2.8 Facility Size Less than 4,000 treatments 2 ...... 1,105 2.5 0.4 0.0 3.0 4,000 to 9,999 treatments ...... 2,225 11.6 0.5 0.0 3.0 10,000 or more treatments ...... 2,370 27.2 0.4 0.0 3.0 Unknown ...... 26 0.0 0.2 0.1 3.2 Percentage of Pediatric Patients Less than 2% ...... 5,616 41.0 0.5 0.0 3.0 Between 2% and 19% ...... 44 0.4 0.3 ¥0.1 3.0 Between 20% and 49% ...... 8 0.0 0.1 ¥0.1 4.1 More than 50% ...... 58 0.1 ¥0.2 0.0 2.2 1 Includes hospital based facilities not reported to have large dialysis organization or regional chain ownership. 2 Of the 1,105 Facilities with less than 4,000 treatments, only 332 qualify for the low-volume adjustment. The low-volume adjustment is man- dated by Congress, and is not applied to pediatric patients. The impact to these Low volume Facilities is a 3.3% increase in payments. 3 Includes the effects of the final payment policy on thrombolytics for those facilities that are paid under the blend.

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4 Includes the effect of Market Basket minus productivity increase of 2.3% to the ESRD PPS base and the Composite Rate. Includes the effect of the change in the drug add-on percentage from 14.3% to 14.0% for those facilities that opted to be paid under the transi- tion. Includes the effect of the blend changing from 50/50 to 25/75 for those facilities that choose to be paid under the transition. Includes the effect of the Transition Budget-Neutrality Factor of 0.1 percent for all facilities. Note: Totals do not necessarily equal the sum of rounded parts.

Column A of the impact table estimated payments in 2013. ESRD 3.0 percent in CY 2013, which translates indicates the number of ESRD facilities facilities in Puerto Rico and the Virgin to approximately $60 million. for each impact category and column B Islands are expected to receive a 0.6 e. Alternatives Considered indicates the number of dialysis percent increase in their estimated treatments (in millions). The overall payments in CY 2013. This smaller We considered eliminating the AY effect of the final changes to the outlier increase is primarily due to the negative modifier use by ESRD facilities in CY payment policy described in section impact of the wage index. The other 2013, which could address program II.C.7 of this final rule is shown in categories of types of facilities in the integrity concerns but could also require column C. For CY 2013, the impact on impact table show positive impacts Medicare beneficiaries to incur all facilities as a result of the changes to ranging from an increase of 2.2 percent additional injections, medical visits and the outlier payment policy would be a to 4.4 percent in their 2013 estimated co-insurance liabilities and accordingly, 0.4 percent increase in estimated payments. we did not pursue this alternative. payments. The estimated impact of the b. Effects on Other Providers Rather, we decided to monitor the use changes to outlier payment policy of the AY modifier and consider the ranges from a 0.2 percent decrease to a Under the ESRD PPS, ESRD facilities elimination of the AY modifier in future 0.6 percent increase. Most ESRD are paid directly for the renal dialysis rulemaking if we determine that it is facilities are anticipated to experience a bundle and other provider types such as being used inappropriately. positive effect in their estimated CY laboratories, DME suppliers, and 2013 payments as a result of the final pharmacies, may no longer bill 2. ESRD QIP outlier policy changes. Medicare directly for renal dialysis a. Effects of the PY 2015 ESRD QIP Column D shows the effect of the services. Rather, effective January 1, wage index on ESRD facilities and 2011, such other providers can only The ESRD QIP provisions are reflects the CY 2013 wage index values furnish renal dialysis services under intended to prevent possible reductions for the composite rate portion of the arrangements with ESRD facilities and in the quality of ESRD dialysis facility blended payment during the transition must seek payment from ESRD facilities services provided to beneficiaries as a and the ESRD PPS payments. Facilities rather than Medicare. Under the ESRD result of payment changes under the located in the census region of Puerto PPS, Medicare pays ESRD facilities one ESRD PPS by implementing an ESRD Rico and the Virgin Islands would payment for renal dialysis services, QIP that reduces ESRD payments by up receive a 2.4 percent decrease in which may have been separately paid to to 2 percent for dialysis facilities that estimated payments in CY 2013. Since suppliers by Medicare prior to the fail to meet or exceed a Total implementation of the ESRD PPS. most of the facilities in this category are Performance Score with respect to Therefore, in CY 2013, the third year of located in Puerto Rico, the decrease is performance standards established by the ESRD PPS, we estimate that the final primarily due to the reduction in the the Secretary with respect to certain ESRD PPS will have zero impact on wage index floor, (which only affects specified measures. The methodology these other providers. facilities in Puerto Rico in CY 2013). that we are finalizing to determine a The other categories of types of facilities c. Effects on the Medicare Program facility’s Total Performance Score is described in section III.D.9 and III.D.10 in the impact table show changes in We estimate that Medicare spending estimated payments ranging from a 0.5 of this final rule. Any reductions in (total Medicare program payments) for ESRD payments would begin on January percent decrease to a 1.5 percent ESRD facilities in 2013 will be increase due to the update of the wage 1, 2015 for services furnished on or after approximately $8.4 billion. This January 1, 2015. index. estimate is based on various price As a result, based on the ESRD QIP Column E reflects the overall impact update factors discussed in section VI.B outlined in this final rule, we estimate (that is, the effect of the final outlier in this final rule and takes into account that, of the total number of dialysis policy changes, the effect of the final a projected increase in fee-for-service wage index, the effect of the ESRDB Medicare dialysis beneficiary facilities (including those not receiving market basket increase minus enrollment of 4.0 percent in CY 2013. an ESRD QIP Total Performance Score), productivity adjustment, the effect of approximately 20 percent or 1,093 of the the change in the blended payment d. Effects on Medicare Beneficiaries facilities would likely receive a payment percentage from 50 percent of payments Under the ESRD PPS, beneficiaries are reduction for PY 2015. Facilities that do based on the composite rate system and responsible for paying 20 percent of the not receive a TPS are not eligible for a 50 percent based on the ESRD PPS in ESRD PPS payment amount or blended payment reduction. 2012, to 25/75, respectively, for 2013, payment amount for patients treated in The ESRD QIP impact assessment for those facilities that opted to be paid facilities going through the ESRD PPS assumes an initial count of 5,726 under the transition, and the effect of transition. As a result of the projected dialysis facilities paid through the ESRD the 0.1 percent transition budget- 3.0 percent overall increase in the ESRD PPS. Table 11 shows the overall neutrality adjustment increase). We PPS payment amounts in CY 2013, we estimated distribution of payment expect that overall, ESRD facilities will estimate that there will be an increase reductions resulting from the PY 2015 experience a 3.0 percent increase in in beneficiary co-insurance payments of ESRD QIP.

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TABLE 11—ESTIMATED DISTRIBUTION TABLE 11—ESTIMATED DISTRIBUTION To estimate whether or not a facility OF PY 2015 ESRD QIP PAYMENT OF PY 2015 ESRD QIP PAYMENT would receive a payment reduction REDUCTIONS REDUCTIONS—Continued under the proposed approach, we scored each facility on achievement and Payment Number of Percent of Payment Number of Percent of improvement for each of the proposed reduction facilities facilities reduction clinical measures using the most recent (percent) (percent) facilities facilities data available for each measure shown 0.0 ...... 4308 79.8 2.0 ...... 88 1.6 in Table 12. 0.5 ...... 599 11.1 1.0 ...... 309 5.7 * Note: this table excludes 325 facilities that 1.5 ...... 97 1.8 did not receive a score because they did not have enough data to receive a Total Perform- ance Score.

TABLE 12—DATA USED TO ESTIMATE PY 2015 ESRD QIP PAYMENT REDUCTIONS

Period of time used to calculate achievement thresholds, performance Measure standards, benchmarks, Performance period and improvement thresholds

Hemoglobin Greater Than 12 g/dL ...... Jan 2010–Dec 2010 ...... Jan 2011–Dec 2011. Vascular Access Type % Fistula ...... Oct 2010–Apr 2011 ...... May 2011–Dec 2011. % Catheter ...... Oct 2010–Apr 2011 ...... May 2011–Dec 2011. Kt/V Adult HD ...... Jul 2010–Mar 2011 ...... Apr 2011–Dec 2011. Adult PD ...... Jul 2010–Mar 2011 ...... Apr 2011–Dec 2011. Pediatric HD ...... Jul 2010–Mar 2011 ...... Apr 2011–Dec 2011.

We used claims data for these To estimate the total payment that ESRD facilities will experience an calculations. Clinical measures with less reductions in PY 2015 for each facility aggregate impact of $24.5 million than 11 cases for a facility were not resulting from this final rule, we ($12,087,940 + 12,424,180 = included in that facility’s Total multiplied the total Medicare payments $24,512,120) as a result of the PY 2015 Performance Score. Clinical measures to the facility during the 1-year period ESRD QIP. between January 2011 and December with 11–25 cases for a facility received Table 13 below shows the estimated 2011 by the facility’s estimated payment an adjustment as outlined in section impact of the finalized ESRD QIP III.C.11.a of this final rule. Each reduction percentage expected under the ESRD QIP, yielding a total payment payment reductions to all ESRD facility’s Total Performance Score was facilities for PY 2015. The table details compared to the estimated minimum reduction amount for each facility: (Total ESRD payment in January 2011 the distribution of ESRD facilities by Total Performance Score and the and December 2011 times the estimated facility size (both among facilities payment reduction table found in payment reduction percentage). For PY considered to be small entities and by section III.D.12 of this final rule. 2015 the total payment reduction for all number of treatments per facility), Facilities were required to have a score of the 1,093 facilities expected to geography (both urban/rural and by on at least one clinical measure to receive a reduction is approximately region), and by facility type (hospital receive a Total Performance Score. For $12 million ($12,087,940). Further, we based/freestanding facilities). Given that these simulations, reporting measures estimate that the total costs associated the time periods used for these were not included due to lack of data with the collection of information calculations will differ from those we availability. Therefore, the simulated requirements for PY 2015 described in will use for the PY 2015 ESRD QIP, the facility Total Performance Scores were section V.C. of this final rule would be actual impact of the PY 2015 ESRD QIP calculated using only the clinical approximately $12.4 million for all may vary significantly from the values measure scores. ESRD facilities. As a result, we estimate provided here.

TABLE 13—IMPACT OF ESRD QIP PAYMENT REDUCTIONS TO ESRD FACILITIES FOR CY 2015

Number of Payment Number of facilities reduction Number of Medicare Number of expected to (percent facilities treatments facilities with receive a change in 2009 QIP score payment total ESRD (in millions) reduction payments)

All Facilities ...... 5,726 41.4 5,401 1,093 ¥0.17 Facility Type: Freestanding ...... 5,176 38.0 4,989 931 ¥0.15 Hospital-based ...... 550 3.4 412 162 ¥0.41 Ownership Type: Large Dialysis ...... 3,719 27.3 3,612 662 ¥0.14 Regional Chain ...... 926 7.1 882 151 ¥0.14

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TABLE 13—IMPACT OF ESRD QIP PAYMENT REDUCTIONS TO ESRD FACILITIES FOR CY 2015—Continued

Number of Payment Number of facilities reduction Number of Medicare Number of expected to (percent facilities treatments facilities with receive a change in 2009 QIP score payment total ESRD (in millions) reduction payments)

Independent ...... 636 4.4 584 150 ¥0.22 Hospital-based (non-chain) ...... 434 2.6 318 128 ¥0.43 Unknown ...... 11 0.0 5 2 ¥0.30 Facility Size: Large Entities ...... 4,645 34.4 4,494 813 ¥0.14 Small Entities 1 ...... 1,070 7.0 902 278 ¥0.30 Unknown ...... 11 0.0 5 2 ¥0.30 Urban/Rural Status: 1) Rural ...... 1,267 6.8 1,188 263 ¥0.18 2) Urban ...... 4,459 34.6 4,213 830 ¥0.16 Census Region: Northeast ...... 810 6.5 752 166 ¥0.20 Midwest ...... 1,352 8.5 1,238 310 ¥0.21 South ...... 2,510 18.7 2,420 445 ¥0.15 West ...... 1,001 7.5 952 154 ¥0.13 U.S. Territories 2 ...... 53 0.3 39 18 ¥0.37 Census Division: East North Central ...... 941 6.3 856 227 ¥0.23 East South Central ...... 472 3.1 451 77 ¥0.15 Middle Atlantic ...... 641 5.1 593 143 ¥0.22 Mountain ...... 335 1.9 321 64 ¥0.15 New England ...... 171 1.4 159 23 ¥0.13 Pacific ...... 667 5.6 631 90 ¥0.11 South Atlantic ...... 1,259 9.5 1,217 236 ¥0.16 West North Central ...... 416 2.2 382 83 ¥0.17 West South Central ...... 783 6.0 752 132 ¥0.13 U.S. Territories 2 ...... 41 0.3 39 18 ¥0.37 Facility Size (# of total treatments): Less than 4,000 treatments ...... 1,105 2.5 864 214 ¥0.27 4,000–9,999 treatments ...... 2,225 11.6 2,190 420 ¥0.15 Over 10,000 treatments ...... 2,370 27.2 2,345 459 ¥0.14 Unknown ...... 26 0.0 2 0 ¥0.00 1 Small Entities include hospital-based and satellite facilities and non-chain facilities based on DFC self-reported status. 2 Includes Puerto Rico and Virgin Islands.

The comments we received on this achievement thresholds, and standards DFC to encourage facilities to improve analysis are set forth below. are set forth in this section. their care. We believe the measures Comment: Several commenters b. Alternatives Considered for the PY selected for the ESRD QIP will allow us requested that we provide, for both PY 2015 ESRD QIP In developing the PY to continue focusing on improving the 2014 and PY 2015, the data, 2015 ESRD QIP, we selected measures quality of care that Medicare assumptions, and methodology used to that we believe are important indicators beneficiaries receive from ESRD dialysis calculate the rate of improvement, of patient outcomes and quality of care facilities. performance standards, achievement as discussed in sections III.C, and III.D In developing the scoring thresholds, and benchmarks for all of this final rule. Poor management of methodology for the PY 2015 ESRD QIP, measures to allow stakeholders to have anemia and inadequate dialysis, for we considered a number of alternatives the opportunity to assess the impact on example, can lead to otherwise- including various improvement ranges, facilities so that the community may avoidable hospitalizations, decreased achievement thresholds, and provide meaningful comment. quality of life, and death. Infections are benchmarks. We also considered Commenters also argued that we have also a leading cause of hospitalization whether some of the new measures underestimated the PY 2014 average and death among hemodialysis patients, should be scored based only on payment reduction (i.e., by 36 percent), but there are proven infection control achievement. We also discussed scoring and requested that we provide the methods that have been shown effective some of the clinical measures using a model, data, and assumption we used in reducing morbidity and mortality. We binary methodology (that is, facilities for these estimates. also considered proposing to adopt the receive either zero or 10 points for Response: As we noted above, the PY Standardized Hospitalization Ratio missing or achieving a standard, 2014 final rule was finalized on Admissions (SHR) measure and the respectively). We ultimately decided to November 1, 2011 (76 FR 70228). We Standardized Mortality Ratio (SMR) mirror the PY 2014 ESRD QIP scoring direct commenters to this rule for our measures as part of the PY 2015 ESRD methodology as closely as possible. We analysis of the PY 2014 ESRD QIP. The QIP. While we decided not to propose aim to design a scoring methodology methodology and assumptions that we to adopt the SHR and SMR measures for that is straightforward and transparent used to calculate the estimated rate of the PY 2015 ESRD QIP, we will publicly to facilities, patients, and other improvement, performance standards, report these measure rates/ratios via stakeholders, and we believe that one of

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the ways to obtain this transparency is We also considered multiple baseline Performance Score that includes half of to be as consistent as possible from year- periods for purposes of scoring facilities the maximum score a facility could to-year of the program. We believe that on achievement and improvement. We receive on these measures. We believe this consistency will allow us to better considered periods of the same time and that this methodology appropriately assess the impacts of the ESRD QIP duration, periods occurring at different places emphasis on complete reporting upon facilities and beneficiaries. times, and periods with various from all facilities. Finally, we believe that all scoring durations. We ultimately decided that a We did not receive any comments methodologies for Medicare VBP baseline period of 12-months for both related to this analysis of the programs should be aligned as the achievement and improvement alternatives that we considered for the appropriate given their specific scores is best because it is consistent PY 2015 ESRD QIP. statutory requirements, and the scoring with the PY 2014 program. methodology for the ESRD QIP is Additionally, a 12-month baseline 3. Reductions to Bad Debt Payments for similar to the Hospital Inpatient VBP period prevents issues related to All Medicare Providers Program. seasonality. We finalized achievement When deciding upon how to best and improvement baseline periods Section 3201 of The Middle Class Tax score the Vascular Access Type and Kt/ occurring over different periods of time Extension and Job Creation Act of 2012 V Dialysis Adequacy measure topics, we because we believe that this approach that requires reductions in bad debt considered combining all of the mitigates data lag as much as possible reimbursement to all providers, supplies measures within the measure topic into and also allows us to score all of the and other entities eligible to receive bad one composite measure (that is, having measures on both achievement and debt reimbursement will have a one, combined numerator and one, improvement. Finally, we finalized an significant impact on the operations of combined denominator for all of the achievement baseline period spanning a all affected entities. However, these measures within the topic) rather than calendar year (CY 2011) because this provisions are specifically prescribed by individually scoring each measure and approach allows us to publish the statute and thus, are self-implementing. weighting it appropriately in the numerical values for the performance It is estimated that these provisions will measure topic. We believe that it is standards before the beginning of the result in savings in CY 2013 of $330 important to mirror the NQF performance period. million. Removal of the cap on bad debt specifications for each measure as much In deciding upon the minimum reimbursement to ESRD facilities up to as possible; we also heeded the number of cases required for a facility a facility’s unrecovered cost will have suggestion of the Measures Application to be scored on a measure, we reviewed an impact on ESRD facilities by Partnership to further test composite and discussed many options. We increasing their bad debt reimbursement measures before implementing them. considered keeping the program the amounts. It is estimated that the Therefore, we decided to score measure same as PY 2014 by excluding measures removal of this cap will result in $10 topics where each measure within the with less than 11 cases and applying no million in increased payments to ESRD measure topic is scored individually adjustment. We also discussed facilities for CY 2013. Therefore, it is and then weighted appropriately. including an adjustment for measures estimated that the combined overall We considered requiring facilities to with 11–25 cases. Finally, we discussed savings in the CY 2013 would be $320 report data for 100 percent of their an adjustment applicable to measures million. patients for the Mineral Metabolism and with 26–50 cases. We believe that we C. Accounting Statement Anemia Management reporting should set the case minimum at 11 and measures in order to ensure complete, adopt an adjustment for measures with As required by OMB Circular A–4 accurate data collection. We ultimately 11–25 cases. (available at http:// decided that, because there are some Finally, in deciding upon the www.whitehouse.gov/omb/ situations where a facility cannot calculation of the minimum Total circulars_a004_a-4), in Table 14 below, control whether a patient’s blood is Performance Score, we considered we have prepared an accounting drawn (for example, hospitalization), we scoring the reporting measures at zero, statement showing the classification of should adopt a reporting threshold of consistent with PY 2014. We decided, the transfers and costs associated with less than 100 percent. however, to finalize a minimum Total the various provisions of this final rule.

TABLE 14—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS AND COSTS/SAVINGS

ESRD PPS for CY 2013

Category Transfers

Annualized Monetized Transfers ...... $250 million. From Whom to Whom ...... Federal government to ESRD providers. Increased Beneficiary Co-insurance Payments ...... $60 million. From Whom to Whom ...... Beneficiaries to ESRD providers.

ESRD QIP for PY 2015

Annualized Monetized Transfers ...... ¥$12.1 million.* From Whom to Whom ...... Federal government to ESRD providers.

Category Costs

Annualized Monetized ESRD Provider Costs ...... 12.4 million.**

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TABLE 14—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED TRANSFERS AND COSTS/SAVINGS—Continued

Savings from Congressionally Mandated Reductions of Bad Debt Payments in CY 2013

Category Transfers

Annualized Monetized Bad Debt Payments ...... $¥320 million. From Whom to Whom ...... Federal government to Medicare providers. * It is the reduced payment to the ESRD facilities, which fall below the quality standards as stated in section III.D.12 of this proposed rule. ** It is the cost associated with the collection of information requirements for all ESRD facilities.

VII. Regulatory Flexibility Act Analysis For purposes of the RFA, we estimate this entire group of 1,070 ESRD small The Regulatory Flexibility Act that approximately 19 percent of ESRD entity facilities, a decrease of 0.30% (September 19, 1980, Pub. L. 96–354) facilities are small entities as that term percent in aggregate ESRD payments is (RFA) requires agencies to analyze is used in the RFA (which includes observed. options for regulatory relief of small small businesses, nonprofit The comment we received on this entities, if a rule has a significant impact organizations, and small governmental analysis is set forth below. on a substantial number of small jurisdictions). This amount is based on Comment: One commenter expressed entities. For purposes of the RFA, small the number of ESRD facilities shown in concern that we have not provided entities include small businesses, the ownership category in Table 9. additional funding for the ESRD QIP nonprofit organizations, and small Using the definitions in this ownership COI requirements to alleviate the governmental jurisdictions. category, we consider the 636 facilities aggregate associated cost; commenter is Approximately 19 percent of ESRD that are independent and the 434 specifically concerned of the impact on dialysis facilities are considered small facilities that are shown as hospital- small facilities. entities according to the Small Business based to be small entities. The ESRD Response: We recognize that a facility Administration’s (SBA) size standards, facilities that are owned and operated may have additional costs resulting which classifies small businesses as by LDOs and regional chains would from the ESRD QIP. We believe that those dialysis facilities having total have total revenues of more than $34.5 these costs, however, are necessary in revenues of less than $34.5 million in million in any year when the total improving care and do not outweigh the any 1 year. Individuals and States are revenues for all locations are combined utility of the program. We will continue not included in the definitions of a for each business (individual LDO or to monitor these costs, paying specific small entity. For more information on regional chain), and are not, therefore, attention to their effect upon small SBA’s size standards, see the Small included as small entities. facilities. Business Administration’s Web site at For the ESRD PPS updates in this Therefore, the Secretary has http://www.sba.gov/sites/default/files/ rule, a hospital-based ESRD facility (as determined that this final rule will not files/Size_Standards_Table.pdf (Kidney defined by ownership type) is estimated have a significant economic impact on Dialysis Centers are listed as 621492 to receive a 3.6 percent increase in a substantial number of small entities. with a size standard of $34.5 million). payments for CY 2013. An independent In addition, section 1102(b) of the Act The claims data used to estimate facility (as defined by ownership type) requires us to prepare a regulatory payments to ESRD facilities in this RFA is estimated to receive a 3.0 percent impact analysis if a rule may have a analysis and RIA do not identify which increase in payments for 2013. significant impact on the operations of dialysis facilities are part of a large Based on the ESRD QIP payment a substantial number of small rural dialysis organization (LDO), regional reduction impacts to ESRD facilities for hospitals. Any such regulatory impact chain, or other type of ownership PY 2015, we estimate that of the 1,093 analysis must conform to the provisions because each individual dialysis facility ESRD facilities expected to receive a of section 604 of the RFA. For purposes has its own provider number and bills payment reduction, 278 ESRD small of section 1102(b) of the Act, we define Medicare using this number. Therefore, entity facilities will experience a a small rural hospital as a hospital that in previous RFA analyses and RIAs payment reduction (ranging from 0.5 is located outside of a metropolitan presented in proposed and final rules percent up to 2.0 of total payments). We statistical area and has fewer than 100 that updated the basic case-mix adjusted anticipate the payment reductions to beds. We do not believe this final rule composite payment system, we average approximately $11,059 per will have a significant impact on considered each ESRD facility to be a facility among the 1,093 facilities operations of a substantial number of small entity for purposes of the RFA receiving a payment reduction, with an small rural hospitals because most analysis. However, we conducted a average of $12,866 per small entity dialysis facilities are freestanding. special analysis for this final rule that facilities receiving a payment reduction. While there are 180 rural hospital-based enabled us to identify the ESRD The projected impacts for these small dialysis facilities, we do not know how facilities that are part of an LDO or entities are estimates based on current many of them are based at hospitals regional chain and therefore, were able data. The actual impacts may differ. with fewer than 100 beds. However, to identify individual ESRD facilities Using our projections of facility overall, the 180 rural hospital-based that will be considered small entities. performance, we then estimated the dialysis facilities will experience an We do not believe ESRD facilities are impact of anticipated payment estimated 3.5 percent increase in operated by small government entities reductions on ESRD small entities, by payments. As a result, this final rule is such as counties or towns with comparing the total payment reductions estimated to not have a significant populations of 50,000 or less, and for the 278 small entities expected to impact on small rural hospitals. therefore, they are not enumerated or receive a payment reduction, with the Therefore, the Secretary has determined included in this estimated RFA analysis. aggregate ESRD payments to all small that this final rule will not have a Individuals and States are not included entities. We estimate that there are a significant economic impact on a in the definition of a small entity. total of 1,070 small entity facilities. For substantial number of small entities.

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Section 3201 of The Middle Class Tax continue to post the Addenda through (v) For cost reporting periods Extension and Job Creation Act of 2012 the Internet. beginning during a subsequent fiscal that requires reductions in bad debt Readers who experience any problems year, by 35 percent. reimbursement to all providers, supplies accessing the Addenda that are posted (2) Skilled nursing facilities and swing and other entities eligible to receive bad on the CMS Web site at http:// bed hospitals. For the purposes of this debt reimbursement will have a www.cms.gov/ESRDPayment/PAY/ paragraph (h)(2), a dual eligible significant impact on the operations of list.asp, should contact Michelle Cruse individual is defined as an individual a substantial number of small entities at (410) 786–7540. that is entitled to benefits under Part A and small rural hospitals. However, List of Subjects of Medicare and is determined eligible these provisions are specifically by the State for medical assistance prescribed by the Congress and thus, are 42 CFR Part 413 under Title XIX of the Act as described self-implementing. Additionally, we do Health facilities, Kidney diseases, under paragraph (2) of the definition of not believe that the removal of the cap Medicare, Reporting and recordkeeping a ‘‘full-benefit dual eligible individual’’ on bad debt reimbursements to ESRD requirements. at § 423.772 of this chapter. In facilities up to their unrecovered costs determining reasonable costs for a will have a significant impact on the 42 CFR Part 417 skilled nursing facility and for post- operations of a substantial number of Administrative practice and hospital SNF care furnished in a swing small entities and small rural hospitals. procedure, Grant programs—health, bed hospital, as defined in § 413.114(b), Thus, we are not providing a Regulatory Health care, Health insurance, Health the amount of allowable bad debt (as Flexibility Act Analysis to codify the maintenance organizations (HMO), Loan defined in paragraph (e) of this section) statutorily mandated reductions in bad programs—health, Medicare, Reporting is reduced: debt payments, nor for the removal of and recordkeeping requirements. (i) For non-dual eligible individuals— the cap on bad debt reimbursement as For the reasons set forth in the (A) For cost reporting periods beginning it pertains to ESRD facilities. preamble, the Centers for Medicare & during fiscal years 2006 through 2012, VIII. Unfunded Mandates Reform Act Medicaid Services amends 42 CFR by 30 percent, for a patient in a skilled Analysis chapter IV as follows: nursing facility. (B) For cost reporting periods Section 202 of the Unfunded PART 413—PRINCIPLES OF beginning during a subsequent fiscal Mandates Reform Act of 1995 (UMRA) REASONABLE COST year, by 35 percent, for a patient in a (Pub. L. 104–4) also requires that REIMBURSEMENT; PAYMENT FOR skilled nursing facility or receiving post- agencies assess anticipated costs and END–STAGE RENAL DISEASE hospital SNF care in a swing bed benefits before issuing any rule whose SERVICES; OPTIONAL hospital. mandates require spending in any 1 year PROSPECTIVELY DETERMINED (ii) For dual eligible individuals—(A) $100 million in 1995 dollars, updated PAYMENT RATES FOR SKILLED For cost reporting periods beginning annually for inflation. In 2012, that NURSING FACILITIES during fiscal year 2013, by 12 percent, threshold is approximately $139 for a patient in a skilled nursing facility million. This final rule does not include ■ 1. The authority citation for part 413 or a patient receiving post-hospital SNF any mandates that will impose spending is revised to read as follows: care in a swing bed hospital. costs on State, local, or Tribal Authority: Secs. 1102, 1812(d), 1814(b), (B) For cost reporting periods governments in the aggregate, or by the 1815, 1833(a), (i), and (n), 1861(v), 1871, beginning during fiscal year 2014, by 24 private sector, of $139 million. 1881, 1883 and 1886 of the Social Security Act (42 U.S.C. 1302, 1395d(d), 1395f(b), percent, for a patient in a skilled IX. Federalism Analysis 1395g, 1395l(a), (i), and (n), 1395x(v), nursing facility or a patient receiving Executive Order 13132 on Federalism 1395hh, 1395rr, 1395tt, and 1395ww); and post-hospital SNF care in a swing bed (August 4, 1999) establishes certain sec. 124 of Pub. L. 106–113 (113 Stat. 1501A– hospital. 332) and sec. 3201 of Pub. L. 112–96 (126 (C) For cost reporting periods requirements that an agency must meet Stat. 156). when it promulgates a final rule that beginning during a subsequent fiscal imposes substantial direct requirement Subpart F—Specific Categories of year, by 35 percent, for a patient in a costs on State and local governments, Costs skilled nursing facility or a patient preempts State law, or otherwise has receiving post-hospital SNF care in a swing bed hospital. Federalism implications. We have ■ 2. Section 413.89 is amended by (3) End-stage renal dialysis facilities. reviewed this final rule under the revising paragraphs (h)(1) introductory In determining reasonable costs for an threshold criteria of Executive Order text, (h)(1)(iv), (h)(2), (h)(3), and (i), and end-stage renal dialysis facility, the 13132, Federalism, and have by adding paragraphs (h)(1)(v) and (h)(4) amount of allowable bad debt (as determined that it will not have to read as follows: substantial direct effects on the rights, defined in paragraph (e) of this section) roles, and responsibilities of States, § 413.89 Bad debts, charity, and courtesy is: local or Tribal governments. allowances. (i) For cost reporting periods * * * * * beginning before October 1, 2012, X. Files Available to the Public via the (h) * * * reimbursed up to the facility’s costs. Internet (1) Hospitals. In determining (ii) For cost reporting periods This section lists the Addenda reasonable costs for hospitals, the beginning on or after October 1, 2012 referred to in the preamble of this final amount of allowable bad debt (as and before January 1, 2013, reduced by rule. Beginning in CY 2012, the defined in paragraph (e) of this section) 12 percent with the resulting amount Addenda for the annual ESRD PPS is reduced: reimbursed up to the facility’s costs. proposed and final rulemakings will no * * * * * (iii) For cost reporting periods longer appear in the Federal Register. (iv) For cost reporting periods beginning on or after January 1, 2013 Instead, the Addenda will be available beginning during fiscal years 2001 and before October 1, 2013, reduced by only through the Internet. We will through 2012, by 30 percent. 12 percent.

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(iv) For cost reporting periods renal dialysis prospective payment § 417.536 Cost payment principles. beginning during fiscal year 2014, system described in § 413.215, bad debts * * * * * reduced by 24 percent. arising from covered items or services (f) * * * (v) For cost reporting periods that, prior to January 1, 2011 were paid beginning during a subsequent fiscal under a reasonable charge-based (1) Bad debts attributable to Medicare year, reduced by 35 percent. methodology or a fee schedule, deductible and coinsurance amounts are (4) All other providers. In determining including but not limited to drugs, allowable only if the requirements of reasonable costs for all other providers, laboratory tests, and supplies are not § 413.89 of this chapter are met, subject suppliers and other entities not reimbursable under the program. to the limitations described under described elsewhere in paragraph (h) of § 413.89(h) and the exceptions for § 413.178 [Removed and Reserved] this section that are eligible to receive services described under § 413.89(i). reimbursement for bad debts under this ■ 3. Section 413.178 is removed and * * * * * section, the amount of allowable bad reserved. debts (as defined in paragraph (e) of this (Catalog of Federal Domestic Assistance section) is reduced: PART 417—HEALTH MAINTENANCE Program No. 93.773, Medicare—Hospital (i) For cost reporting periods ORGANIZATIONS, COMPETITIVE Insurance; and Program No. 93.774, beginning during fiscal year 2013, by 12 MEDICAL PLANS, AND HEALTH CARE Medicare—Supplementary Medical percent. PREPAYMENT PLANS Insurance Program) (ii) For cost reporting periods beginning during fiscal year 2014, by 24 ■ 4. The authority citation for part 417 Dated: October 26, 2012. percent. continues to read as follows: Marilyn Tavenner, (iii) For cost reporting periods Acting Administrator, Centers for Medicare beginning during a subsequent fiscal Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and & Medicaid Services. year, by 35 percent. 1395hh), secs. 1301, 1306, and 1310 of the (i) Exceptions applicable to bad debt Kathleen Sebelius, Public Health Service Act (42 U.S.C. 300e, Secretary, Department of Health and Human reimbursement. (1) Bad debts arising 300e–5, and 300e–9), and 31 U.S.C. 9701. from covered services paid under a Services. reasonable charge-based methodology or Subpart O—Medicare Payment: Cost [FR Doc. 2012–26903 Filed 11–2–12; 4:15 pm] a fee schedule are not reimbursable Basis BILLING CODE 4120–01–P under the program. (2) For end-stage renal dialysis ■ 5. Section 417.536 is amended by services furnished on or after January 1, revising paragraph (f)(1) to read as 2011 and paid for under the end-stage follows:

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Reader Aids Federal Register Vol. 77, No. 218 Friday, November 9, 2012

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING NOVEMBER

Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 18...... 66288 Presidential Documents 3 CFR 21...... 66288 Executive orders and proclamations 741–6000 Proclamations: 22...... 66288 The United States Government Manual 741–6000 8894...... 66507 36...... 66288 8895...... 66515 Other Services 38...... 66288 8896...... 66517 41...... 66288 741–6020 Electronic and on-line services (voice) 8897...... 66519 140...... 66288 Privacy Act Compilation 741–6064 8898...... 66521 145...... 66288 Public Laws Update Service (numbers, dates, etc.) 741–6043 8899...... 66523 155...... 66288 TTY for the deaf-and-hard-of-hearing 741–6086 8900...... 66525 166...... 66288 8901...... 66527 240...... 66220 ELECTRONIC RESEARCH Executive Orders: 13629...... 66353 18 CFR World Wide Web Administrative Orders: Proposed Rules Full text of the daily Federal Register, CFR and other publications Notices: 284...... 66568 is located at: www.fdsys.gov. Notice of November 1, 26 CFR Federal Register information and research tools, including Public 2012 ...... 66359 Inspection List, indexes, and links to GPO Access are located at: 1...... 66915 7 CFR www.ofr.gov. Proposed Rules 205...... 67239 E-mail 1...... 66938 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is 12 CFR 29 CFR an open e-mail service that provides subscribers with a digital 19...... 66529 1401...... 66539 form of the Federal Register Table of Contents. The digital form 109...... 66529 1926...... 67270 of the Federal Register Table of Contents includes HTML and 204...... 66361 Proposed Rules PDF links to the full text of each document. 615...... 66362 1926...... 67313 To join or leave, go to http://listserv.access.gpo.gov and select 652...... 66375 Online mailing list archives, FEDREGTOC-L, Join or leave the list Proposed Rules 30 CFR (or change settings); then follow the instructions. 1026...... 66748 Proposed Rules 1238...... 66566 943...... 66574 PENS (Public Law Electronic Notification Service) is an e-mail service that notifies subscribers of recently enacted laws. 14 CFR 31 CFR To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 25...... 67251 552...... 67276 and select Join or leave the list (or change settings); then follow 39 ...... 66534, 67254, 67256, 561...... 66918 the instructions. 67261, 67263, 67267 FEDREGTOC-L and PENS are mailing lists only. We cannot 71 ...... 66067, 66068, 66069 33 CFR respond to specific inquiries. 97...... 66535, 66536 100...... 66713 Reference questions. Send questions and comments about the 400...... 67269 117...... 66714 Federal Register system to: [email protected] Proposed Rules 165...... 66541 25...... 67308, 67309 Proposed Rules The Federal Register staff cannot interpret specific documents or 33...... 66936 100...... 66938 regulations. 39 ...... 66409, 66411, 66413, 110...... 66942 Reminders. Effective January 1, 2009, the Reminders, including 66415, 66417, 66566, 66757, 117...... 67319 Rules Going Into Effect and Comments Due Next Week, no longer 66760, 66762, 66764, 66767, appear in the Reader Aids section of the Federal Register. This 66769, 66771, 66772 34 CFR information can be found online at http://www.regulations.gov. 674...... 66088 15 CFR CFR Checklist. Effective January 1, 2009, the CFR Checklist no 682...... 66088 longer appears in the Federal Register. This information can be Proposed Rules 685...... 66088 found online at http://bookstore.gpo.gov/. 764...... 66777 766...... 66777 37 CFR 202...... 66920 FEDERAL REGISTER PAGES AND DATE, NOVEMBER 16 CFR 38 CFR 66067–66148...... 1 1223...... 66703 9...... 66069 66149–66360...... 2 17 CFR Proposed Rules 66361–66514...... 5 1...... 66288 3...... 66419 66515–66702...... 6 4...... 66288 66703–66914...... 7 5...... 66288 39 CFR 66915–67238...... 8 7...... 66288 111...... 66149 67239–67532...... 9 8...... 66288 15...... 66288 40 CFR 16...... 66288 9...... 66149

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52 ...... 66388, 66398, 66405, 42 CFR 67...... 66555, 66737 1150...... 66165 66543, 66545, 66547, 66548, 409...... 67068 206...... 67285 1180...... 66165 66715, 66921, 66927, 66929 413...... 67450 Proposed Rules 180 ...... 66715, 66721, 66723, 67 ...... 66165, 66785, 66788, 417...... 67450 50 CFR 67282 424...... 67068 66790, 66791, 67324, 67325 300...... 66729 17...... 67302 438...... 66670 47 CFR 721...... 66149 441...... 66670 21...... 66406 Proposed Rules 447...... 66670 64...... 66935 622...... 66744, 67303 52 ...... 66421, 66422, 66429, 484...... 67068 73...... 66743 648...... 66746, 67305 66780, 66945, 67322 488...... 67068 76...... 67290 679...... 66564 174...... 66781 Proposed Rules 489...... 67068 Proposed Rules 180...... 66781 498...... 67068 25...... 67172 300...... 66783 424...... 66946 49 CFR 648...... 66169, 66947 41 CFR 44 CFR Proposed Rules 660...... 66577, 67327 303...... 66554 64...... 66733 1121...... 66165

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The text of laws is not S. 3624/P.L. 112–196 enacted public laws. To published in the Federal Military Commercial Driver’s subscribe, go to http:// LIST OF PUBLIC LAWS Register but may be ordered License Act of 2012 (Oct. 19, listserv.gsa.gov/archives/ in ‘‘slip law’’ (individual 2012; 126 Stat. 1459) publaws-l.html This is a continuing list of pamphlet) form from the public bills from the current Superintendent of Documents, Last List October 11, 2012 session of Congress which U.S. Government Printing Note: This service is strictly have become Federal laws. It Office, Washington, DC 20402 for E-mail notification of new may be used in conjunction (phone, 202–512–1808). The Public Laws Electronic laws. The text of laws is not with ‘‘P L U S’’ (Public Laws text will also be made Notification Service available through this service. Update Service) on 202–741– available on the Internet from (PENS) PENS cannot respond to 6043. This list is also GPO’s Federal Digital System specific inquiries sent to this available online at http:// (FDsys) at http://www.gpo.gov/ address. www.archives.gov/federal- fdsys. Some laws may not yet PENS is a free electronic mail register/laws. be available. notification service of newly

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