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Code · REGISTER · 2007-08-31 · PROPOSED RULES · Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Food Safety and Inspection Service See Forest Service See Natural Resources Conservation Service See Rural Housing · Unknown

Unknown. Interim rule; technical amendment

29,654 words·~135 min read·/register/2007/08/31/07-4292

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2007-08-31.xml --- 72 169 Friday, August 31, 2007 Contents Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Food Safety and Inspection Service See Forest Service See Natural Resources Conservation Service See Rural Housing Service Animal Animal and Plant Health Inspection Service RULES Phytosanitary treatments; cold treatment enclosures and requirements Technical amendment, 50201-50204 E7-17295 Army Army Department See Engineers Corps NOTICES Patent licenses; non-exclusive, exclusive, or partially exclusive:
Liquid immersed pumped solid state laser, 50331 07-4275 Radar beam steering with remote reflectory/refraction, 50331-50332 07-4276 Blind Blind or Severely Disabled, Committee for Purchase From People Who Are See Committee for Purchase From People Who Are Blind or Severely Disabled Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 50371-50372 E7-17293 Centers Centers for Medicare & Medicaid Services RULES Medicaid Program and State Children's Health Insurance Program:
Payment error rate measurement, 50490-50513 07-4240 Medicare: Hospice wage index (2008 FY), 50214-50249 07-4292 PROPOSED RULES Medicare and Medicaid: Ambulatory surgical centers; coverage conditions, 50470-50487 07-4148 NOTICES Agency information collection activities; proposals, submissions, and approvals, 50372-50373 E7-17351 Children Children and Families Administration NOTICES Grant and cooperative agreement awards: University of Texas Health Science Center; Prevention Research Center, 50373 E7-17216 Coast Guard Coast Guard RULES Regattas and marine parades:
Cambridge Offshore Challenge, 50212-50214 E7-17337 Fleet Week Parade of Navy Ships and Blue Angels, 50214 E7-17340 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See National Oceanic and Atmospheric Administration Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement list; additions and deletions, 50323-50325 E7-17321 E7-17322 E7-17323 Commodity Commodity Futures Trading Commission RULES Special calls for information, 50209-50211 E7-17100 Community Community Development Financial Institutions Fund NOTICES Grants and cooperative agreements; availability, etc.:
Community Development Financial Institutions Program, 50446-50457 E7-17324 Defense Defense Department See Army Department See Engineers Corps See Navy Department RULES Consumer credit extended to service members and dependents; terms limitations, 50580-50594 07-4264 Drug Drug Enforcement Administration NOTICES Registration revocations, restrictions, denials, reinstatements: United Prescription Services, Inc., 50397-50410 E7-17223 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 50335 E7-17338 Grants and cooperative agreements; availability, etc.:
Postsecondary education— Fulbright-Hays Faculty Research Abroad and Fellowship Program, 50335-50339 E7-17362 Fulbright-Hays Group Projects Abroad Program, 50339-50343 E7-17365 Special education and rehabilitative services— Disability and Rehabilitation Research Projects and Centers Program, 50516-50541 E7-17199 Privacy Act; systems of records, 50343-50346 E7-17367 Energy Energy Department See Federal Energy Regulatory Commission Engineers Engineers Corps PROPOSED RULES Danger zones and restricted areas:
Marine Corps Base Hawaii, Keneohe Bay, Oahu, HI, 50303-50305 E7-17155 NOTICES Environmental statements; availability, etc.: DeKalb County, TN; Center Hill Dam and Lake, 50332 07-4277 Environmental statements; notice of intent: Long Island Sound, NY; Dredged Material Management Plan, 50332-50333 07-4274 EPA Environmental Protection Agency PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: Connecticut, 50305-50311 E7-17196 NOTICES Environmental statements; availability, etc.:
Agency comment availability, 50368 E7-17334 Agency weekly receipts, 50368-50369 E7-17336 Environmental statements; notice of intent: Red Dog Mine Extension-Aqqaluk Project, AK, 50369 E7-17306 Executive Executive Office of the President See Presidential Documents See Trade Representative, Office of United States FAA Federal Aviation Administration RULES Airworthiness directives: Pratt & Whitney, 50204-50208 E7-17210 Airworthiness standards: Transport category airplanes— Airplane performance and handling qualities in icing conditions; correction, 50467 Z7-14937 Commercial space transportation:
Reusable suborbital rockets; experimental permits Reporting and recordkeeping requirements, 50209 E7-17368 PROPOSED RULES Airworthiness directives: Alexandria Aircraft, LLC, 50297-50300 E7-17289 Boeing, 50276-50284, 50292-50297 E7-17280 E7-17283 E7-17284 E7-17285 E7-17290 E7-17294 Bombardier, 50288-50290 E7-17282 Fokker, 50274-50276 E7-17296 McDonnell Douglas, 50284-50288 E7-17287 Restricted areas, 50300-50301 E7-17361 NOTICES Agency information collection activities; proposals, submissions, and approvals, 50438 07-4289 Exemption petitions; summary and disposition, 50438-50439 E7-17370 E7-17371 FBI Federal Bureau of Investigation NOTICES Agency information collection activities; proposals, submissions, and approvals, 50410 E7-17275 FCC Federal Communications Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 50369-50371 E7-17327 E7-17329 Federal Election Federal Election Commission PROPOSED RULES Corporate and labor organization activity:
Electioneering communications, 50261-50274 E7-17184 Federal Emergency Federal Emergency Management Agency RULES Flood elevation determinations: North Dakota and Virginia, 50255-50257 E7-17319 Various States, 50250-50255 E7-17341 PROPOSED RULES Flood elevation determinations: Alabama, 50317-50318 E7-17352 Various States, 50311-50317 E7-17346 NOTICES Disaster and emergency areas: Missouri, 50378 E7-17315 Nebraska, 50378-50379 E7-17314 E7-17316 Texas, 50379-50380 E7-17317 E7-17318 Federal Energy Federal Energy Regulatory Commission NOTICES Complaints filed:
ConocoPhillips Co., 50354 E7-17243 H-P Energy Resources LLC, 50354 E7-17240 Electric rate and corporate regulation combined filings, 50354-50356 E7-17302 Environmental statements; availability, etc.: Virginia Electric & Power Co., 50356 E7-17252 Environmental statements; notice of intent: LNG Development Co., LLC, et al., 50356-50359 E7-17259 Hydroelectric applications, 50359-50368 E7-17239 E7-17244 E7-17245 E7-17246 E7-17247 E7-17253 E7-17254 E7-17255 E7-17258 E7-17269 *Applications, hearings, determinations, etc.:* CenterPoint Energy Gas Transmission Co., 50346 E7-17237 Cheyenne Plains Gas Pipeline Co., L.L.C., et al., 50346 E7-17266 Columbia Gulf Transmission Co. et al., 50347 E7-17263 Dominion Cove Point LNG, LP, 50347 E7-17257 Dominion Transmission, Inc., 50347-50348 E7-17260 Enron Power Marketing, Inc., et al., 50348 E7-17309 Entergy Services, Inc., 50348 E7-17256 Enterprise Alabama Intrastate, LLC, 50348 E7-17248 Florida Gas Transmission Co., LLC, 50348-50349 E7-17251 E7-17268 MIGC, Inc., 50349 E7-17264 Mittal Steel USA, Inc., 50350 E7-17241 PJM Interconnection, LLC, 50350 E7-17310 Questar Overthrust Pipeline Co., 50350-50351 E7-17262 Questar Pipeline Co., 50351 E7-17267 Rochester Gas & Electric Corp., 50351 E7-17242 Sabine Pipe Line LLC, 50351-50352 E7-17249 Saltville Gas Storage Company L.L.C., 50352 E7-17261 Scurry County Wind I..P., 50352 E7-17311 Western Area Power Administration, 50353 E7-17308 WTG Hugoton, LP, 50353 E7-17238 Wyoming Interstate Co., Ltd., 50353 E7-17265 Federal Highway Federal Highway Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 50440-50441 E7-17339 Environmental statements; notice of intent:
Los Angeles County, CA, 50441-50442 E7-17301 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 50442 E7-17325 Motor vehicle safety standards: Driver qualifications; diabetes exemptions, 50442-50445 E7-17348 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 50371 E7-17313 Fish Fish and Wildlife Service PROPOSED RULES Migratory bird hunting:
Federal Indian reservations, off-reservation trust lands, and ceded lands, 50596-50613 07-4235 Seasons, limits and shooting hours; establishment, etc., 50613-50638 07-4236 Food Food and Drug Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 50373-50374 E7-17217 Meetings: Import Safety Presidential Interagency Working Group, 50374-50376 E7-17305 Food Food Safety and Inspection Service PROPOSED RULES Regulatory Flexibility Act:
Section 610 requirements; regulations review plan— Pathogen reduction/hazard analysis and critical control point (HACCP) systems, 50260-50261 E7-17212 Foreign Foreign-Trade Zones Board NOTICES *Applications, hearings, determinations, etc.:* Alabama ArvinMeritor, Inc.; automotive door modules manufacturing facility, 50325 E7-17366 California Sharp Electronics Corp.; office and consumer electronics/home products/solar panels warehousing and distribution facility, 50325-50326 E7-17328 Iowa— SPAL USA, Inc.; vehicle parts distribution and processing, 50326 E7-17333 Kansas— Hospira Inc.; pharmaceutical products, 50326-50327 E7-17331 Ohio, 50327 E7-17364 Pennsylvania, 50327 E7-17347 Forest Forest Service NOTICES Meetings:
Resource Advisory Committees— Northeast Oregon Forests, 50322 E7-17303 Tri-County, 50322 07-4271 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Industry Industry and Security Bureau NOTICES Meetings:
Transportation and Related Equipment Technical Advisory Committee, 50327-50328 07-4281 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Minerals Management Service See National Park Service See Surface Mining Reclamation and Enforcement Office IRS Internal Revenue Service RULES Excise taxes: Return requirement and filing time Correction, 50211-50212 E7-17227 PROPOSED RULES Income taxes: Benefit restrictions; underfunded pension plans, 50544-50577 07-4262 NOTICES Agency information collection activities; proposals, submissions, and approvals, 50457-50465 E7-17214 E7-17215 E7-17218 E7-17220 E7-17232 Meetings:
Taxpayer Advocacy Panels, 50465 E7-17222 International International Trade Commission NOTICES Import investigations: Lemon juice from— Argentina and Mexico, 50396 E7-17270 Tomatoes and peppers; U.S. imports monitoring, 50396-50397 E7-17230 Justice Justice Department See Drug Enforcement Administration See Federal Bureau of Investigation Labor Labor Department See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Coal leases, exploration licenses, etc.:
Wyoming, 50380-50381 E7-17332 Meetings: Resource Advisory Councils— Eastern Washington, 50381 E7-17291 Northeast California, 50381-50382 E7-17363 Utah, 50381 E7-17300 Realty actions; sales, leases, etc.: Arizona; correction, 50382 E7-17307 Maritime Maritime Administration NOTICES Deepwater ports; license applications: Clearwater Port LLC, 50445-50446 E7-17326 Minerals Minerals Management Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 50382-50387 E7-17278 Outer Continental Shelf operations:
Central Gulf of Mexico— Oil and gas lease sales, 50387-50393 E7-17281 E7-17286 National Highway National Highway Traffic Safety Administration PROPOSED RULES Motor vehicle safety standards: Threshold warning signal, anti-stow interlock, and occupied inner roll stop interlock requirements; rulemaking petition denied, 50318-50321 E7-17374 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 50376-50377 07-4270 Meetings:
National Institute on Aging, 50377 07-4268 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Atlantic highly migratory species— Bluefin tuna, 50257-50259 07-4283 NOTICES Endangered and threatened species permit applications, determinations, etc., 50328-50330 E7-17350 Environmental statements; notice of intent: West Coast States and Western Pacific fisheries— Western Pacific pelagic; Hawaii-based longline swordfish fishery, 50330 E7-17349 Fishery conservation and management:
South Atlantic vermilion snapper and gag; overfishing determinations, 50330 E7-17335 Marine mammal permit applications, determinations, etc., 50330-50331 E7-17320 National Park National Park Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 50393 07-4272 Environmental statements; notice of intent: Glen Canyon National Recreation Area, AZ and UT; off-road vehicle management plan, 50393-50394 07-4273 National Register of Historic Places; pending nominations, 50394-50395 E7-17382 National Science National Science Foundation NOTICES Agency information collection activities; proposals, submissions, and approvals, 50410-50411 07-4287 Antarctic Conservation Act of 1978; permit applications, etc., 50411-50412 E7-17234 Environmental statements; availability, etc.:
Eastern Pacific Ocean and Caribbean Sea; marine geophysical survey, 50412-50413 07-4267 Meetings: Environmental Research and Education Advisory Committee, 50413 E7-17342 Geosciences Advisory Committee, 50413-50414 E7-17344 Ocean Sciences Proposal Review Panel, 50414 E7-17343 NRCS Natural Resources Conservation Service NOTICES Meetings: Agricultural Air Quality Task Force, 50322-50323 07-4265 Navy Navy Department NOTICES Environmental statements; availability, etc.: Gulf of Mexico Range Complex;
Atlantic Fleet training; scoping meetings, 50333-50335 E7-17360 Nuclear Nuclear Regulatory Commission NOTICES Environmental statements; notice of intent: Uranium milling facilities; meetings, 50414-50416 E7-17276 Meetings: Nuclear Waste and Materials Advisory Committee [ **Editorial Note:** This document appearing at 72 FR 49744 in the **Federal Register** of August 29, 2007, was incorrectly indexed in that issue's Table of Contents]. U.S. digital instrumentation and control and human-machine interface workshop, 50416-50417 E7-17299 Occupational Occupational Safety and Health Administration PROPOSED RULES Safety and health standards, etc.:
Personal protective equipment; agency standards update Hearing, 50302-50303 E7-17183 Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Personnel Personnel Management Office NOTICES Meetings: Federal Salary Council, 50419 E7-17221 Presidential Presidential Documents PROCLAMATIONS *Special observances:* Minority Enterprise Development Week (Proc. 8169), 50639-50642 07-4313 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals; correction, 50419-50420 E7-17273 Rural Rural Housing Service NOTICES Grants and cooperative agreements; availability, etc.:
Section 538 Guaranteed Rural Rental Housing Program; correction, 50323 E7-17219 SEC Securities and Exchange Commission NOTICES Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 50420-50425 E7-17272 E7-17353 E7-17354 Financial Industry Regulatory Authority, Inc., 50425-50426 E7-17271 International Securities Exchange, LLC, 50426-50429 E7-17355 National Stock Exchange, Inc., 50429-50431 E7-17228 NYSE Arca, Inc., 50431-50436 E7-17274 E7-17376 State State Department NOTICES Clean Diamond Trade Act: participating countries entities eligible for trade in rough diamonds; list, 50436-50437 07-4260 Committees; establishment, renewal, termination, etc.:
Defense Trade Advisory Group, 50437-50438 E7-17330 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 50377-50378 E7-17277 Surface Surface Mining Reclamation and Enforcement Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 50395-50396 07-4280 Trade Trade Representative, Office of United States NOTICES World Trade Organization:
Dispute settlement panel proceedings— China; measures granting refunds, reductions, or exemptions from taxes and other payments., 50417-50418 E7-17357 India; additional and extra additional duties on imports, 50418-50419 E7-17358 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Maritime Administration See National Highway Traffic Safety Administration Treasury Treasury Department See Community Development Financial Institutions Fund See Internal Revenue Service See United States Mint U.S.
U.S.-China Economic and Security Review Commission NOTICES Hearings; correction, 50465-50466 E7-17298 U.S. Mint United States Mint NOTICES Meetings: Citizens Coinage Advisory Committee, 50465 E7-17213 Veterans Veterans Affairs Department NOTICES Meetings: CARES Business Plan Studies Advisory Committee, 50466 07-4279 Special Medical Advisory Group, 50466 07-4278 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 50470-50487 07-4148 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 50490-50513 07-4240 Part IV Education Department, 50516-50541 E7-17199 Part V Treasury Department, Internal Revenue Service, 50544-50577 07-4262 Part VI Defense Department, 50580-50594 07-4264 Part VII Interior Department, Fish and Wildlife Service, 50596-50638 07-4235 07-4236 Part VIII Executive Office of the President, Presidential Documents, 50639-50642 07-4313 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 169 Friday, August 31, 2007 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 305 [Docket No. APHIS-2006-0050] Cold Treatment Regulations; Technical Amendment AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule; technical amendment. SUMMARY: In an interim rule published in the **Federal Register** on July 2, 2007, with an effective date of August 31, 2007, we amended the phytosanitary treatment regulations by making several changes to the requirements for cold treatment enclosures and the requirements for conducting cold treatment. A final rule that was published in the **Federal Register** on July 18, 2007, and effective August 17, 2007, reorganized the cold treatment regulations by moving requirements regarding cold treatment that had previously been contained in the regulations governing the importation of fruits and vegetables to the section of the regulations containing the requirements for cold treatment enclosures and conducting cold treatment.
This technical amendment indicates how the changes in the July 2 interim rule will appear in the regulations as they have been reorganized by the July 18 final rule. DATES: This technical amendment is effective on August 31, 2007. FOR FURTHER INFORMATION CONTACT: Dr. Inder P.S. Gadh, Senior Risk Manager—Treatments, Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236;
(301)734-8758. SUPPLEMENTARY INFORMATION: Background The phytosanitary treatments regulations contained in 7 CFR part 305 set out standards and schedules for treatments required in 7 CFR parts 301, 318, and 319 for fruits, vegetables, and articles to prevent the introduction or dissemination of plant pests or noxious weeds into or through the United States. Within part 305, the cold treatments subpart (§§ 305.15 and 305.16, referred to below as the regulations) sets out requirements for performing cold treatment and cold treatment schedules for imported fruits and vegetables and for regulated articles moved interstate from quarantined areas within the United States. Section 305.15 sets out the requirements for performing cold treatment. These requirements include standards that must be met by the facility performing cold treatment and the enclosure in which cold treatment is performed; monitoring requirements; procedural requirements for performing cold treatment; and a required compliance agreement or workplan to ensure that these requirements are followed, under appropriate oversight from the Animal and Plant Health Inspection Service (APHIS). In an interim rule 1 titled “Cold Treatment Regulations” and published in the **Federal Register** on July 2, 2007, with an effective date of August 31, 2007 (72 FR 35909-35915, Docket No. APHIS-2006-0050), we amended § 305.15 by making several changes to the requirements for cold treatment enclosures and the requirements for conducting cold treatment. The changes include: Adding more specific and stringent requirements for precooling fruit prior to cold treatment, requiring the use of temperature recording devices that are password-protected and tamperproof, adding requirements to increase the effectiveness of cold treatment conducted in vessel holds, and providing for officials authorized by APHIS to conduct audits of the cold treatment process. 1 To view the interim rule, go to *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0050.* In a separate final rule 2 titled “Revision of Fruits and Vegetables Import Regulations” and published in the **Federal Register** on July 18, 2007 and effective August 17, 2007, we revised and reorganized the regulations pertaining to the importation of fruits and vegetables to consolidate requirements of general applicability and eliminate redundant requirements, update terms and remove outdated requirements and references, update the regulations that apply to importations into territories under U.S. administration, and make various editorial and nonsubstantive changes to regulations to make them easier to use. As part of this final rule, we reorganized the cold treatment regulations in § 305.15 by moving requirements to § 305.15 that had previously been found in the regulations governing the importation of fruits and vegetables, specifically in § 319.56-2d. The final rule moved into § 305.15 all the provisions contained in § 319.56-2d that were not already present in § 305.15. The regulations were otherwise not amended. However, these changes necessitated a reorganization of the regulations in § 305.15. 2 To view the final rule, go to *http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2005-0106-0060.* Due to this reorganization, the amendatory language in the July 2 interim rule no longer refers to the provisions in the regulations that we intended to amend through that interim rule. This technical amendment sets out the regulations in § 305.15 as they will appear when the July 2 interim rule and this technical amendment become effective on August 31, 2007. This technical amendment does not change the provisions of the July 2 interim rule; it only establishes how the provisions of the July 2 interim rule will appear in § 305.15 as amended by the July 18 final rule. We have provided a table showing where the provisions of the July 2 interim rule will appear in § 305.15 as that section was reorganized by the July 18 final rule for the convenience of the reader. Table 1.—Location of Provisions From July 2, 2007, Interim Rule in the Reorganized § 305.15 Subparagraph from July 2 interim rule: Now appears in § 305.15 as: (b)(1) (c)(1). (b)(2) (c)(2). (f)(1) (d)(1). (f)(2) (d)(3). (f)(3) (d)(4). (f)(4) (d)(5). (f)(5) (d)(6). (f)(6) (d)(7) (see below). (f)(7) (d)(8). (f)(8) (d)(9). (f)(9) (d)(10) (see below). (f)(10) (d)(11). (f)(11) (d)(12) (see below). (f)(12) (d)(13). (f)(13) (d)(14). Paragraph
(d)of § 305.15 as amended by the July 18 final rule sets out requirements related to precooling fruit. The precooling requirements in the July 2 interim rule (which that rule would have added in paragraph (f)(3)) were intended to replace all previous precooling requirements. Accordingly, this technical amendment will remove paragraph
(d)of § 305.15 from the regulations. Paragraphs (e), (f), (g), and
(h)in § 305.15 will be redesignated as (d), (e), (f), and (g), respectively. Paragraph (c)(4) of § 305.15 as amended by the July 18 final rule sets out requirements for temperature sensors. Paragraph (f)(6) in the July 2 interim rule contained requirements that complement those in (c)(4). To collect all the requirements relating to temperature sensors in one place, this technical amendment will add paragraph (f)(6) from the July 2 interim rule to § 305.15 as paragraph (d)(7), will incorporate into that paragraph (d)(7) the requirements from former (c)(4), and will remove paragraph (c)(4) of § 305.15. In the July 2 interim rule, paragraph (f)(6) read: Temperature recording devices used during treatment must be password-protected and tamperproof. The devices must be able to record the date, time, sensor number, and temperature during all calibrations and during treatment. If records of calibrations or treatments are found to have been manipulated, the vessel or container in which the treatment is performed may be suspended from conducting cold treatments until proper equipment is installed and an official authorized by APHIS has recertified it. APHIS' decision to recertify a vessel or container will take into account the severity of the infraction that led to suspension. Paragraph (c)(4) indicates that the cold treatment enclosure must be equipped with recording devices, such that automatic, continuous temperature records are maintained and secured, and that recording devices must be capable of generating temperature charts for verification of treatment by an inspector. The new paragraph (d)(7) in § 305.15 will thus read: Temperature recording devices used during treatment must be password-protected and tamperproof. The devices must be able to record the date, time, and sensor number and automatic and continuous records of the temperature during all calibrations and during treatment. Recording devices must be capable of generating temperature charts for verification by an inspector. If records of calibrations or treatments are found to have been manipulated, the vessel or container in which the treatment is performed may be suspended from conducting cold treatments until proper equipment is installed and an official authorized by APHIS has recertified it. APHIS' decision to recertify a vessel or container will take into account the severity of the infraction that led to suspension. Paragraph (f)(9) in the July 2 interim rule stated: “The time required to complete the treatment begins when all temperature probes reach the prescribed cold treatment schedule temperature.” This paragraph was intended to replace a more general provision requiring that the time to complete the treatment begins when the temperature inside the fruit reaches the required temperature. The July 18 final rule added to that provision a requirement that refrigeration continue until the vessel arrives at the port of destination and the fruit is released for unloading by an inspector even though this may prolong the period required for the cold treatment. This technical amendment will amend § 305.15 to retain both the requirement from the July 2 interim rule relating to the temperature probes and the refrigeration requirement established in the regulations by the July 18 final rule. Paragraph (f)(11) of the July 2 interim rule referred to conditions under which shipments of treated commodities may be discharged. Paragraph (e)(10) contains a similar statement that refers to consignments, rather than shipments. The term “consignments” is the preferred term, as it is used in international standards. Accordingly, we will add (f)(11) to § 305.15 as (d)(12), but we will replace the word “shipments” with the word “consignments.” For the reasons given in the July 2 interim rule, this technical amendment will remove the requirements in the first sentence of paragraph (e)(9) and in paragraph (e)(11), as these paragraphs appear in the July 18 final rule. Paragraphs (e)(13) and (e)(14) in the current form of § 305.15 will appear as paragraphs (d)(15) and (d)(16), respectively. However, the requirements in paragraph (e)(17) of § 305.15 will appear in a new paragraph
(h)at the end of the section. Paragraph (e)(17) sets out additional requirements for treatments performed after arrival in the United States at specific ports; we believe it will assist the reader to set out all the general conditions applying to cold treatment before listing port-specific conditions. List of Subjects in 7 CFR Part 305 Irradiation, Phytosanitary treatment, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements. Accordingly, we are amending 7 CFR part 305 as follows: PART 305—PHYTOSANITARY TREATMENTS 1. The authority citation for 7 CFR part 305 continues to read as follows: Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3. 2. Section 305.15 is amended as follows: a. By revising paragraph
(c)to read as set forth below. b. By removing paragraph (d). c. By redesignating paragraphs (e), (f), (g), and
(h)as paragraphs (d), (e), (f), and (g), respectively. d. By revising newly redesignated paragraph
(d)to read as set forth below. e. By adding a new paragraph
(h)to read as set forth below. § 305.15 Treatment requirements.
(c)*Cold treatment enclosures.* All enclosures in which cold treatment is performed, including refrigerated containers, must:
(1)Be capable of maintaining the treatment temperature before the treatment begins and holding fruit at or below the treatment temperature during the treatment.
(2)Maintain fruit pulp temperatures according to treatment schedules with no more than a 0.39 °C (0.7 °F) variation in temperature.
(3)Be structurally sound and adequate to maintain required temperatures.
(d)*Treatment procedures.*
(1)All material, labor, and equipment for cold treatment performed on vessels must be provided by the vessel or vessel agent. An official authorized by APHIS monitors, manages, and advises in order to ensure that the treatment procedures are followed.
(2)Refrigeration must be completed in the container, compartment, or room in which it is begun.
(3)Fruit that may be cold treated must be safeguarded to prevent cross- contamination or mixing with other infested fruit.
(4)Fruit intended for in-transit cold treatment must be precooled to the temperature at which the fruit will be treated prior to beginning treatment. The in-transit treatment enclosure may not be used for precooling unless an official authorized by APHIS approves the loading of the fruit in the treatment enclosure as adequate to allow for fruit pulp temperatures to be taken prior to beginning treatment. If the fruit is precooled outside the treatment enclosure, an official authorized by APHIS will take pulp temperatures manually from a sample of the fruit as the fruit is loaded for in-transit cold treatment to verify that precooling was completed. If the pulp temperatures for the sample are 0.28 C (0.5 F) or more above the temperature at which the fruit will be treated, the pallet from which the sample was taken will be rejected and returned for additional precooling until the fruit reaches the treatment temperature. If fruit is precooled in the treatment enclosure, or if treatment is conducted at a cold treatment facility in the United States, the fruit must be precooled to the temperature at which it will be treated, as verified by an official authorized by APHIS, prior to beginning treatment.
(5)Breaks, damage, etc., in the treatment enclosure that preclude maintaining correct temperatures must be repaired before the enclosure is used. An official authorized by APHIS must approve loading of compartment, number and placement of temperature probes or sensors, and initial fruit temperature readings before beginning the treatment. Hanging decks and hatch coamings within vessels may not be used as enclosures for in-transit cold treatment without prior written approval from APHIS. Double-stacking of pallets is not allowed.
(6)Only the same type of fruit in the same type of package may be treated together in a container; no mixture of fruits in containers may be treated. A numbered seal must be placed on the doors of the loaded container and may be removed only at the port of destination by an official authorized by APHIS.
(7)Temperature recording devices used during treatment must be password-protected and tamperproof. The devices must be able to record the date, time, and sensor number and automatic and continuous records of the temperature during all calibrations and during treatment. Recording devises must be capable of generating temperature charts for verification by an inspector. If records of calibrations or treatments are found to have been manipulated, the vessel or container in which the treatment is performed may be suspended from conducting cold treatments until proper equipment is installed and an official authorized by APHIS has recertified it. APHIS' decision to recertify a vessel or container will take into account the severity of the infraction that led to suspension.
(8)A minimum of four temperature probes or sensors is required for vessel holds used as treatment enclosures. A minimum of three temperature probes or sensors is required for other treatment enclosures. An official authorized by APHIS will have the option to require that additional temperature probes or sensors be used, depending on the size of the treatment enclosure.
(9)Fruit pulp temperatures must be maintained at the temperature specified in the treatment schedule with no more than a 0.39 C (0.7 °F) variation in temperature between two consecutive hourly readings. Failure to comply with this requirement will result in invalidation of the treatment unless an official authorized by APHIS can verify that the pulp temperature was maintained at or below the treatment temperature for the duration of the treatment.
(10)The time required to complete the treatment begins when all temperature probes reach the prescribed cold treatment schedule temperature. Refrigeration continues until the vessel arrives at the port of destination and the fruit is released for unloading by an inspector even though this may prolong the period required for the cold treatment.
(11)Temperatures must be recorded at intervals no longer than 1 hour apart. Gaps of longer than 1 hour will invalidate the treatment or indicate treatment failure unless an official authorized by APHIS can verify that the pulp temperature was maintained at or below the treatment temperature for the duration of the treatment.
(12)Cold treatment is not completed until so declared by an official authorized by APHIS or the certifying official of the foreign country; consignments of treated commodities may not be discharged until APHIS clearance has been fully completed, including review and approval of treatment record charts.
(13)Cold treatment of fruits in break bulk vessels or containers must be initiated by an official authorized by APHIS if there is not a treatment technician who has been trained to initiate cold treatments for either break bulk vessels or containers.
(14)An official authorized by APHIS may perform audits to ensure that the treatment procedures comply with the regulations in this subpart. The official authorized by APHIS must be given the appropriate materials and access to the facility, container, or vessel necessary to perform the audits.
(15)*Inspection of fruits after cold treatment for Mediterranean fruit fly.* An inspector will sample and cut fruit from each consignment cold treated for Mediterranean fruit fly (Medfly) to monitor treatment effectiveness. If a single live Medfly in any stage of development is found, the consignment will be held until an investigation is completed and appropriate remedial actions have been implemented. If APHIS determines at any time that the safeguards contained in this section do not appear to be effective against the Medfly, APHIS may suspend the importation of fruits from the originating country and conduct an investigation into the cause of the deficiency.
(16)*Caution and disclaimer.* The cold treatments required for the entry of fruit are considered necessary for the elimination of plant pests, and no liability shall attach to the U.S. Department of Agriculture or to any officer or representative of that Department in the event injury results to fruit offered for entry in accordance with these instructions. In prescribing cold treatments of certain fruits, it should be emphasized that inexactness and carelessness in applying the treatments may result in injury to the fruit or its rejection for entry.
(h)*Additional requirements for treatments performed after arrival in the United States.*
(1)*Maritime port of Wilmington, NC.* Consignments of fruit arriving at the maritime port of Wilmington, NC, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following special conditions:
(i)Bulk consignments (those consignments which are stowed and unloaded by the case or bin) of fruit must arrive in fruit fly-proof packaging that prevents the escape of adult, larval, or pupal fruit flies.
(ii)Bulk and containerized consignments of fruit must be cold-treated within the area over which the U.S. Department of Homeland Security is assigned the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force.
(iii)Advance reservations for cold treatment space must be made prior to the departure of a consignment from its port of origin.
(iv)The cold treatment facility must remain locked during non-working hours.
(2)*Maritime port of Seattle, WA.* Consignments of fruit arriving at the maritime port of Seattle, WA, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following special conditions:
(i)Bulk consignments (those consignments which are stowed and unloaded by the case or bin) of fruit must arrive in fruit fly-proof packaging that prevents the escape of adult, larval, or pupal fruit flies.
(ii)Bulk and containerized consignments of fruit must be cold treated within the area over which the U.S. Department of Homeland Security is assigned the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force.
(iii)Advance reservations for cold treatment space must be made prior to the departure of a consignment from its port of origin.
(iv)The cold treatment facility must remain locked during non-working hours.
(v)Blacklight or sticky paper must be used within the cold treatment facility, and other trapping methods, including Jackson/methyl eugenol and McPhail traps, must be used within the 4 square miles surrounding the cold treatment facility.
(vi)The cold treatment facility must have contingency plans, approved by the Administrator, for safely destroying or disposing of fruit.
(3)*Airports of Atlanta, GA, and Seattle, WA.* Consignments of fruit arriving at the airports of Atlanta, GA, and Seattle, WA, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following special conditions:
(i)Bulk and containerized consignments of fruit must arrive in fruit fly-proof packaging that prevents the escape of adult, larval, or pupal fruit flies.
(ii)Bulk and containerized consignments of fruit arriving for cold treatment must be cold treated within the area over which the U.S. Department of Homeland Security is assigned the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force.
(iii)The cold treatment facility and APHIS must agree in advance on the route by which consignments are allowed to move between the aircraft on which they arrived at the airport and the cold treatment facility. The movement of consignments from aircraft to a cold treatment facility will not be allowed until an acceptable route has been agreed upon.
(iv)Advance reservations for cold treatment space must be made prior to the departure of a consignment from its port of origin.
(v)The cold treatment facility must remain locked during non-working hours.
(vi)Blacklight or sticky paper must be used within the cold treatment facility, and other trapping methods, including Jackson/methyl eugenol and McPhail traps, must be used within the 4 square miles surrounding the cold treatment facility.
(vii)The cold treatment facility must have contingency plans, approved by the Administrator, for safely destroying or disposing of fruit.
(4)*Maritime ports of Gulfport, MS, and Corpus Christi, TX.* Consignments of fruit arriving at the ports of Gulfport, MS, and Corpus Christi, TX, for cold treatment, in addition to meeting all other applicable requirements of this section, must meet the following special conditions:
(i)All fruit entering the port for cold treatment must move in maritime containers. No bulk consignments (those consignments which are stowed and unloaded by the case or bin) are permitted.
(ii)Within the container, the fruit intended for cold treatment must be enclosed in fruit fly-proof packaging that prevents the escape of adult, larval, or pupal fruit flies.
(iii)All consignments of fruit arriving at the port for cold treatment must be cold treated within the area over which the U.S. Department of Homeland Security is assigned the authority to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs and navigation laws in force.
(iv)The cold treatment facility and APHIS must agree in advance on the route by which consignments are allowed to move between the vessel on which they arrived at the port and the cold treatment facility. The movement of consignments from vessel to cold treatment facility will not be allowed until an acceptable route has been agreed upon.
(v)Advance reservations for cold treatment space at the port must be made prior to the departure of a consignment from its port of origin.
(vi)Devanning, the unloading of fruit from containers into the cold treatment facility, must adhere to the following requirements:
(A)All containers must be unloaded within the cold treatment facility; and
(B)Untreated fruit may not be exposed to the outdoors under any circumstances.
(vii)The cold treatment facility must remain locked during non-working hours.
(viii)Blacklights or sticky paper must be used within the cold treatment facility, and other trapping methods, including Jackson/methyl eugenol and McPhail traps, must be used within the 4 square miles surrounding the cold treatment facility at the maritime port of Gulfport, MS, and within the 5 square miles surrounding the cold treatment facility at the maritime port of Corpus Christi, TX.
(ix)During cold treatment, a backup system must be available to cold treat the consignments of fruit should the primary system malfunction. The facility must also have one or more reefers (cold holding rooms) and methods of identifying lots of treated and untreated fruits.
(x)The cold treatment facility must have the ability to conduct methyl bromide fumigations on site.
(xi)The cold treatment facility must have contingency plans, approved by the Administrator, for safely destroying or disposing of fruit. Done in Washington, DC, this 27th day of August 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-17295 Filed 8-30-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-23072; Directorate Identifier 2005-NE-38-AD; Amendment 39-15186; AD 2007-18-06] RIN 2120-AA64 Airworthiness Directives; Pratt & Whitney JT9D-7R4 Turbofan Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is superseding an existing airworthiness directive
(AD)for Pratt & Whitney
(PW)JT9D-7R4 turbofan engines. That AD currently requires inspection of the blade root thickness of 1st stage fan blades identified by part number (P/N) and serial number
(SN)in the AD. This AD requires the same actions but corrects 12 P/Ns, adds 10 part SNs, and adds the definition of next fan blade exposure to the compliance section. This AD results from the discovery of inaccurate part quantity, part numbers, and serial numbers used in AD 2005-26-09. We are issuing this AD to prevent 1st stage fan blade fracture and uncontained engine failure, resulting in possible damage to the airplane. DATES: This AD becomes effective October 5, 2007. ADDRESSES: The Docket Operations office is located at U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. FOR FURTHER INFORMATION CONTACT: Kevin Donovan, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803-5299; telephone
(781)238-7743, fax
(781)238-7199. SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39 by superseding AD 2005-26-09, Amendment 39-14430 (70 FR 76381, December 27, 2005), with a proposed AD. The proposed AD applies to
(PW)JT9D-7R4 turbofan engines. We published the proposed AD in the **Federal Register** on March 1, 2007 (72 FR 9276). That action proposed to require inspection of the blade root thickness of 1st stage fan blades identified by P/N and SN. Examining the AD Docket You may examine the AD docket on the Internet at *http://dms.dot.gov;* or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comment received. Duplicate Serial Number One commenter asks us to remove a duplicate serial number from Table 1. The commenter states that we listed two fan blades, P/N 831021, serial number NS8559 in Table 1. We agree. We deleted one of the duplicate SNs. Corrections to the NPRM We found one typographical error in a blade SN. We changed ND6924 to ND8924. Blade SN ND6924 is not included in the population of suspect blades. We also found the population is not 531, it is 538. We corrected these errors in the NPRM. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will cause only a minimal increase to the economic burden on any operator and will not increase the scope of the AD. Costs of Compliance We estimate that this AD will affect 538 1st stage fan blades installed on JT9D-7R4 turbofan engines installed on airplanes of U.S. registry. We also estimate that it will take about 0.5 work-hour per 1st stage fan blade to perform the proposed actions, and that the average labor rate is $80 per work-hour. Based on these figures, we estimate the total cost of this AD to U.S. operators to be $21,520. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. *For the reasons discussed above, I certify that this AD:*
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration amends 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by removing Amendment 39-14430 70 FR 76381, December 27, 2005, and by adding a new airworthiness directive, Amendment 39-15196, to read as follows: **2007-18-06 Pratt & Whitney:** Amendment 39-15196. Docket No. FAA-2005-23072; Directorate Identifier 2005-NE-38-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective October 5, 2007. Affected ADs
(b)This AD supersedes AD 2005-26-09. Applicability
(c)This AD applies to Pratt & Whitney
(PW)JT9D-7R4 turbofan engines. These engines are installed on, but not limited to, Airbus A300 and A310, and Boeing 747 and 767 airplanes. Unsafe Condition
(d)This AD results from the discovery of inaccurate part quantity, part numbers (P/Ns), and serial numbers
(SNs)used in AD 2005-26-09. We are issuing this AD to prevent 1st stage fan blade fracture and uncontained engine failure, resulting in possible damage to the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done.
(f)For 1st stage fan blades that are listed by P/N and SN in Table 1 of this AD, do the following: Table 1.—Affected 1st Stage Fan Blades P/Ns SNs 5001341-022 JW2804 5001341-022 JW0354 5001341-022 ND5746 5001341-022 ND5770 5001341-022 JW3992 5001341-022 ND8615 5001341-022 JW0442 5001341-022 JW2317 5001341-022 ND8631 5001341-022 ND8635 5001341-022 JW4624 5001341-022 NE0394 5001341-022 NE0153 5001341-022 NN8054 5001341-022 JW4693 5001341-022 ND7304 5001341-022 MG6108 5001341-022 MG5862 5001341-022 MG5619 5001341-022 NE0308 5001341-022 NE0200 5001341-022 MG6797 5001341-022 JW0230 5001341-022 ND5652 5001341-022 ND5775 5001341-022 JW0251 5001341-022 ND5719 5001341-022 JW0248 5001341-022 ND5785 5001341-022 ND5676 5001341-022 ND5661 5001341-022 JW0265 5001341-022 ND5699 5001341-022 ND5767 5001341-022 JW0259 5001341-022 ND5680 5001341-022 ND5749 5001341-022 JW0235 5001341-022 ND5776 5001341-022 ND8580 5001341-022 MG6039 5001341-022 ND9127 5001341-022 JW4287 5001341-022 JW0262 5001341-022 JW0445 5001341-022 JW4665 5001341-022 MG5901 5001341-022 NE0303 5001341-022 ND8703 5001341-022 JW4574 5001341-022 JW4286 5001341-022 JW4491 5001341-022 JW4630 5001341-022 JW4391 5001341-022 MG6550 5001341-022 MG6776 5001341-022 JW4586 5001341-022 JW0352 5001341-022 JW4261 5001341-022 MG6135 5001341-022 JW4685 5001341-022 MG6772 5001341-022 MG6793 5001341-022 MG7111 5001341-022 ND8618 5001341-022 JW0644 5001341-022 JW4631 5001341-022 JW4651 5001341-022 JW0234 5001341-022 JW4646 804121 NN9016 804121 VJ3393 804121 PX3694 804121 RK9168 804121 PX5023 804121 VJ3324 804121 VJ3504 804121 NN9115 804121 NN8936 804121 PX3816 804121 VJ3412 804121 RK9163 804121 VJ3447 804121 RK9230 804121 RK9109 804121 PX4627 804121 RK8990 804121 SP9459 804121 RK8656 804121 NN8933 804121 VJ3444 804121 ND5864 804121 NN9020 804121 RK8905 804121 SR1733 804121 NN9047 804121 PX3692 804121 PX3786 804121 NN9025 804121 NN9007 804121 RK9100 804121 VJ3399 804121 PX4970 804121 PX5013 804121 RK8904 804121 NN8986 804121 NN8829 804121 VJ3459 804121 RK9143 804121 VJ3414 804121 NN9028 804121 SP1557 804121 PX5003 804121 PX5042 804121 VJ3475 804121 ND7330 804121 PX3714 831021-003 NS8913 831021-003 ND6512 831021-003 ND6941 831021-003 ND9576 831021-003 NS7555 831021-003 NS8286 831021-003 NS7447 831021-003 ND6488 831021-003 ND8296 831021-003 ND6956 831021-003 ND7879 831021-003 ND6509 831021-003 ND9814 831021-003 NN7331 831021-003 ND6991 831021-003 ND6894 831021-003 NS6413 831021-003 ND7344 831021-003 ND6947 831021-003 NN8732 831021-003 ND8536 831021-003 ND6946 831021-003 ND6723 831021-003 ND9294 831021-003 ND9290 831021-003 ND6013 831021-003 ND8937 831021-003 NS7160 831021-003 NS6435 831021-003 NS6591 831021-003 ND9558 831021-003 NS8479 831021-003 NS9382 831021-003 ND8965 831021-003 ND9837 831021-003 ND5959 831021-003 NS6491 831021-003 NS9072 831021-003 ND9625 831021-003 ND6714 831021-003 ND6820 831021-003 ND8972 831021-003 NE0286 831021-003 NE0347 831021-003 ND8010 831021-003 ND8956 831021-003 ND9535 831021-003 ND9831 831021-003 NE0227 831021-003 ND8283 831021-003 ND9730 831021-003 NN7656 831021-003 NS7775 831021-003 ND9815 831021-003 ND6135 831021-003 NS8491 831021-003 NS6395 831021-003 NS8584 831021-003 NN7272 831021-003 MG7159 831021-003 NS6592 831021-003 ND7862 831021-003 ND6684 831021-003 NN7744 831021-003 ND7480 831021-003 ND7873 831021-003 ND6827 831021-003 ND6576 831021-003 ND9261 831021-003 NS8686 831021-003 ND9052 831021-003 ND6897 831021-003 ND6565 831021-003 NN8966 831021-003 PX3707 831021-003 NS7031 831021-003 ND6584 831021-003 ND9883 831021-003 NS6535 831021-003 ND7852 831021-003 ND9662 831021-003 ND7871 831021-003 JW0106 831021-003 ND8305 831021-003 NS6409 831021-003 NE0442 831021-003 ND9095 831021-003 ND9302 831021-003 ND9023 831021-003 ND8009 831021-003 ND8477 831021-003 ND7492 831021-003 ND8776 831021-003 ND6524 831021-003 ND6704 831021-003 ND8911 831021-003 ND8789 831021-003 ND8798 831021-003 ND6407 831021-003 ND7668 831021-003 ND9179 831021-003 NE0421 831021-003 ND6513 831021-003 ND6744 831021-003 ND7654 831021-003 ND7870 831021-003 ND9759 831021-003 ND6561 831021-003 ND5826 831021-003 ND6031 831021-003 ND8714 831021-003 ND8872 831021-003 ND6678 831021-003 ND6629 831021-003 ND8995 831021-003 NE0302 831021-003 ND6405 831021-003 NS8300 831021-003 NS8769 831021-003 NS7147 831021-003 ND6649 831021-003 ND7766 831021-003 NS7864 831021-003 NS8734 831021-003 ND6677 831021-003 NS7911 831021-003 ND8205 831021-003 ND8804 831021-003 ND6639 831021-003 ND8994 831021-003 ND7275 831021-003 ND9195 831021-003 ND6178 831021-003 ND8639 831021-003 ND9760 831021-003 ND9108X 831021-003 ND6427 831021-003 ND6590 831021-003 NS6551 831021-003 JW1158 831021-003 ND6412 831021-003 ND7922 831021-003 NS8678 831021-003 ND8930 831021-003 ND6596 831021-003 ND9570 831021-003 NN9027 831021-003 ND6446 831021-003 NE0275 831021-003 ND9917 831021-003 NS7919 831021-003 NS7907 831021-003 ND6583 831021-003 NN7420 831021-003 ND7746 831021-003 ND8187 831021-003 NN8999 831021-003 ND6043 831021-003 ND7880 831021-003 NN7175 831021-003 ND9816 831021-003 ND8174 831021-003 ND6045 831021-003 NS7562 831021-003 JW0075 831021-003 ND6848 831021-003 ND8531 831021-003 ND6311 831021-003 ND8144 831021-003 ND5798 831021-003 ND8113 831021-003 ND9642 831021-003 ND7436 831021-003 ND9054 831021-003 ND9683 831021-003 ND5991 831021-003 ND6026 831021-003 ND6616 831021-003 ND6530 831021-003 NE0374 831021-003 ND6364 831021-003 ND7718 831021-003 ND6473 831021-003 ND6436 831021-003 ND6887 831021-003 ND6518 831021-003 ND6479 831021-003 NS6330 831021-003 ND7264 831021-003 ND8151 831021-003 ND6562 831021-003 NS8776 831021-003 ND6519 831021-003 ND7659 831021-003 NS9049 831021-003 NS6861 831021-003 ND9571 831021-003 ND9346 831021-003 ND6501 831021-003 NS8505 831021-003 ND9338 831021-003 ND9775 831021-003 ND6485 831021-003 ND7165 831021-003 ND9371 831021-003 ND9537 831021-003 NS7889 831021-003 ND7877 831021-003 ND8670 831021-003 ND9032 831021-003 ND8781 831021-003 ND8604 831021-003 ND9329 831021-003 ND9110 831021-003 ND5997 831021-003 ND6027 831021-003 ND9589 831021-003 ND6575 831021-003 ND6592 831021-003 ND6463 831021-003 NS8583 831021-003 NS8590 831021-003 NS8567 831021-003 NS6795 831021-003 NS7110 831021-003 NS6587 831021-003 NS6404 831021-003 ND6486 5001341-022 JW0942 5001341-022 ND9231 5001341-022 JW4812 5001341-022 ND6555 5001341-022 M1375 5001341-022 MG6627 5001341-022 MG6794 5001341-022 ND9399 5001341-022 NE0084 5001341-022 MG6252 5001341-022 ND7422 5001341-022 ND7043 5001341-022 MG5722 5001341-022 MG5918 5001341-022 ND6984 5001341-022 M0839 5001341-022 M0922 5001341-022 M0938 5001341-022 M1117 5001341-022 M0307 5001341-022 JW3871 5001341-022 M1125 5001341-022 M1149 5001341-022 JW2681 5001341-022 M0270 5001341-022 M1120 5001341-022 M0205 5001341-022 AE9352 5001341-022 JW3492 5001341-022 ND6148 5001341-022 ND8907 5001341-022 M1235 5001341-022 MG5585 5001341-022 ND8436 5001341-022 MG5696 5001341-022 ND8704 5001341-022 JW2284 5001341-022 JW2313 5001341-022 JW2498 5001341-022 JW2541 5001341-022 JW2560 5001341-022 JW2589 5001341-022 JW2639 5001341-022 JW2760 5001341-022 JW2792 5001341-022 M0579 5001341-022 MG2825 5001341-022 MG5477 5001341-022 ND5917 5001341-022 JW1976 5001341-022 JW2653 5001341-022 JW2608 5001341-022 JW2727 5001341-022 JW2764 5001341-022 JW2265 5001341-022 JW2474 5001341-022 JW2396 5001341-022 JW3554 5001341-022 JW2667 5001341-022 MG2302 5001341-022 MG3972 5001341-022 JW3930 5001341-022 ND6749 5001341-022 M1172 5001341-022 JW2104 5001341-022 JW2519 5001341-022 JW2640 5001341-022 JW2517 5001341-022 JW2663 5001341-022 JW2823 5001341-022 M0536 5001341-022 JW2725 5001341-022 MG5917 5001341-022 JW0681 5001341-022 JW0711 5001341-022 JW0740 5001341-022 JW0807 5001341-022 JW1089 5001341-022 JW1362 5001341-022 JW2065 5001341-022 MG2434 5001341-022 MG2846 5001341-022 JW0806 804121 NN9854 804121 NN9024 804121 NN9032 804121 PX5029 804121 NN9050 804121 NS8242 804121 NS8260 804121 PX4273 804121 PX4378 804121 RL0857 804121 RX8763 804121 NS8331 804121 NN9824 804121 MG6979 804121 MG7023 804121 MG7055 804121 RK8914 804121 RL0023 804121 PX4328 804121 RK9008 804121 TG1506 804121 KK8226 804121 MG2604 804121 NS6691 804121 RK8968 804121 NN9917 804121 RK7824 804121 M1343 804121 NS6559 804121 NS7767 804121 NE0363 804121 PX3771 804121 NN9972 804121 RL0460 804121 RK8310 804121 SR2115 804121 TG2826 804121 PX5018 804121 PX5002 831021-003 ND7627 831021-003 ND6890 831021-003 ND7461 831021-003 ND9616 831021-003 NE0413 831021-003 NS8825 831021-003 NS6350 831021-003 NS7168 831021-003 NS7705 831021-003 NS7848 831021-003 ND9128 831021-003 ND9541 831021-003 ND9671 831021-003 ND9684 831021-003 NE0277 831021-003 NE0384 831021-003 NE0396 831021-003 ND6421 831021-003 ND6599 831021-003 ND6614 831021-003 ND7847 831021-003 ND8346 831021-003 ND8853 831021-003 ND8915 831021-003 NS8719 831021-003 NS8838 831021-003 NT0169 831021-003 NS9584 831021-003 ND6445 831021-003 ND6834 831021-003 ND7467 831021-003 ND8887 831021-003 ND6520 831021-003 NS8611 831021-003 NS7640 831021-003 NN7037 831021-003 NN7590 831021-003 NN8120 831021-003 NN8573 831021-003 NN9719 831021-003 NS8784 831021-003 TB6B367 831021-003 NN9557 831021-003 NN9710 831021-003 NS8374 831021-003 NS8770 831021-003 NS9022 831021-003 NS8416 831021-003 NS6474 831021-003 ND8912 831021-003 NT0108 831021-003 NS8836 831021-003 NN8310 831021-003 NS8559 5001341-022 JW2313 5001341-022 JW2498 5001341-022 JW2541 5001341-022 JW2560 5001341-022 JW2589 5001341-022 JW2639 5001341-022 JW2760 5001341-022 JW2792 5001341-022 JW4713 5001341-022 MG6743 5001341-022 ND8924 831021-003 ND9177 831021-003 ND9496 831021-003 NS7894 831021-003 NS9072 804121 PX3805 804121 PX4266 For Engines Installed on an Airplane
(1)For engines installed on an airplane with affected 1st stage fan blades installed, perform the actions in paragraphs (f)(3) through (f)(6)(ii) of this AD at the next 1st stage fan blade exposure. For Engines Not Installed on an Airplane, or, for Affected 1st Stage Fan Blades Not Installed in an Engine
(2)For engines not installed on an airplane with affected 1st stage fan blades installed, or, for affected 1st stage fan blades not installed in an engine, paragraph
(h)of this AD applies. 1st Stage Fan Blade Check
(3)Check the 1st stage fan blade for a circled, letter I, on the approved marking area of the outboard side of the blade platform. If the blade has this marking, no further action is required.
(4)Remove 1st stage fan blades without a circled, letter I, on the approved marking area of the outboard side of the blade platform, if installed.
(5)Inspect the 1st stage fan blade root thickness. You can find information on inspecting the blade root thickness in PW Engine Manual Section 72-31-02, Inspect-01, and Repair-23.
(6)For 1st stage fan blades that pass the inspection referenced in paragraph (f)(5) of this AD:
(i)Vibropeen the letter I and a circle around that letter, on the approved marking area of the outboard side of the blade platform. You can find information on approved blade marking in the JT9D-7R4 Engine Manual, Section 72-31-02, Typical Repair-13, Mark Repair Codes.
(ii)Return the 1st stage fan blades to service. Definition
(g)For the purposes of paragraph (f)(1) of this AD, next 1st stage fan blade exposure is:
(1)When any 1st stage fan blade is removed from the engine; or
(2)When the 1st stage fan hub is removed from the engine. Prohibited Installation
(h)After the effective date of this AD, do not install any 1st stage fan blades listed in Table 1 of this AD on any airplane, unless the actions of this AD have been done to the 1st stage fan blades. Alternative Methods of Compliance
(i)The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information
(j)None. Issued in Burlington, Massachusetts, on August 24, 2007. Mark A. Rumizen, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E7-17210 Filed 8-30-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 437 [Docket No. FAA-2006-24197; Amendment Nos. 401-5, 404-4, 405-3, 406-4, 413-9, 420-3, 431-2, 437-0] Experimental Permits for Reusable Suborbital Rockets AGENCY: Federal Aviation Administration, DOT. ACTION: Notice of Office of Management and Budget Approval for Information Collection. SUMMARY: This notice announces the Office of Management and Budget's
(OMB)approval of the information collection requirement in the final rule published April 6, 2007 (72 FR 17001). The sections of the final rule pending approval of this information collection request are effective on publication of this notice. DATES: The FAA received OMB approval for the information collection requirement in the Final Rule published on April 6, 2007. The compliance date for information collection requirements in 14 CFR 437.21, 437.25, 437.27, 437.29, 437.31, 437.37, 437.41, 437.53, 437.55, 437.57, 437.59, 437.69, and 437.89 is Augusst 31, 2007. FOR FURTHER INFORMATION CONTACT: Randy Repcheck, Office of Commercial Space Transportation, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:
(202)267-8760; facsimile:
(202)267-5463; e-mail: *randy.repcheck@faa.gov.* SUPPLEMENTARY INFORMATION: Background On April 6, 2007, the FAA published the final rule, “Experimental Permits for Reusable Suborbital Rockets,” in the **Federal Register** . The rule established application requirements for an operator of a manned or unmanned reusable suborbital rocket to obtain an experimental permit. The FAA also established operating requirements and restrictions on launch and re-entry of reusable suborbital rockets operated under a permit. The requirements above are in Title 14 of the Code of Federal Regulations parts 401, 404, 405, 406, 413, 415, 420, 431, and 437. We noted, in the “Paperwork Reduction Act” section of the final rule, that affected parties did not need to comply with the information collection requirements of the rule until the Office of Management and Budget
(OMB)approved the FAA's request to collect the information. In accordance with the Paperwork Reduction Act, OMB approved the FAA's request for new information collection on June 1, 2007, and assigned the information collection OMB Control Number 2120-0722. The control number was not available when the final rule was published, thus necessitating publication of this notice. The FAA request was approved by OMB without change and expires on June 30, 2010. 49 U.S.C. 106(g), 40113, 40119, 41706, 44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 46105, grants authority to the Administrator to publish this notice. The final rule (72 FR 17001) became effective on June 5, 2007, and the compliance date for information collection requirements in 14 CFR 437.21, 437.25, 437.27, 437.29, 437.31, 437.37, 437.41, 437.53, 437.55, 437.57, 437.59, 437.69, and 437.89 is August 31, 2007. Issued in Washington, DC on August 24, 2007. Pamela Hamilton-Powell, Director, Office of Rulemaking. [FR Doc. E7-17368 Filed 8-30-07; 8:45 am] BILLING CODE 4910-13-P COMMODITY FUTURES TRADING COMMISSION 17 CFR Part 21 Special Calls AGENCY: Commodity Futures Trading Commission. ACTION: Final rules. SUMMARY: The Commodity Futures Trading Commission (“Commission”) has adopted amendments to Part 21 of its regulations relating to special calls for information. The amendments will: Add to the types of information specified in § 21.02, which must be furnished upon special call, information regarding exchanges of futures for physical commodities or for derivatives positions, and information regarding delivery notices issued and stopped; and delegate to the Director of the Division of Market Oversight and the Director's delegatees, the ability to issue special calls pursuant to sections 21.01 and 21.02. EFFECTIVE DATE: August 31, 2007. FOR FURTHER INFORMATION CONTACT: Don Heitman, Senior Special Counsel (telephone 202-418-5041, e-mail *dheitman@cftc.gov* ), Division of Market Oversight, Commodity Futures Trading Commission, Three Lafayette Center, 1155 21st Street, NW., Washington, DC 20581. SUPPLEMENTARY INFORMATION: I. Background The Commodity Exchange Act (“Act”), as amended by the Commodity Futures Modernization Act of 2000 (“CFMA”), Pub. L. No. 106-554, is intended, among other things, to “deter and prevent price manipulation or any other disruptions to market integrity.” 1 To that end, the Commission, through its Division of Market Oversight (“Division”), conducts a comprehensive program of market surveillance. A centerpiece of this program is the large-trader reporting system, under which all large futures and option positions are reported to the Commission. Each day, for every active futures or option market, Division surveillance staff monitors the activities of large traders, key price relationships, and all relevant supply and demand factors in a continuous review for potential market problems. An essential element of the Commission's market surveillance program is the ability to make special calls for information from Commission registrants and other market participants. 1 Commodity Exchange Act § 3(b), 7 U.S.C. § 5(b). A. Information To Be Furnished Upon Special Call Part 17 of the Commission's regulations sets forth the routine reports that futures commission merchants, members of contract markets and foreign brokers (collectively, “reporting firms”) are required to submit to the Commission. 2 These reports provide the information for the Commission's large trader reporting system. The Commission uses that information in its market surveillance program to detect and prevent market manipulation or other disruptions to market integrity in markets subject to Commission oversight. 2 The Commission has recently proposed amendments to its definition of the term, ``foreign broker.'' The amended definition would also be relocated, from its current location at § 15.00(g) to § 1.3(xx). *See* 72 FR 15637 (April 2, 2007). If such amendments were to be adopted, there would be no change in a foreign broker's obligations to comply with the Commission's large trader or special call regulations set forth in 17 CFR Parts 15-21. By contrast, the purpose of the Commission's special call authority in Part 21 of the Commission's regulations is to provide the Commission with relevant information that is not routinely supplied to the Commission pursuant to other parts of the Commission's regulations such as Part 17. For example, the Commission may need to know about futures positions that are below the routine reporting levels specified in Part 15 of the Commission's regulations. Among possible reasons for such special needs for information may be a particular market situation that warrants unusually close Commission market surveillance, or when Commission staff is conducting an audit of reporting firms to ensure complete and accurate reporting. The amendments to Part 21 require reporting firms to retain and make available to the Commission, upon a special call, information similar to that which they are required to report to the Commission pursuant to Part 17 of the Commission's regulations. Specifically, the amendments add two additional categories of information to the types of information specified in § 21.02, which must be furnished upon special call. The first additional category of information subject to special call under the amended rules includes information regarding futures contracts exchanged for physical commodities (“EFPs”), as well as futures contracts exchanged for other derivatives contracts, including exchanges of futures for options (“EFOs”) and exchanges of futures for swaps (“EFSs”). The second additional category of information includes the amount of futures contracts where actual delivery of the underlying commodity has been initiated (i.e., delivery notices have been issued or received). Section 21.02 applies to futures commission merchants (“FCMs”), introducing brokers (“IBs”), members of contract markets and foreign brokers. However, the first three of the foregoing categories are already subject to substantial reporting and recordkeeping requirements under § 1.35 of the Commission's regulations, which, among other things, requires FCMs, IBs and contract market members to maintain, and produce on request, the records that are also the subject of these rules. Therefore, as a practical matter, the amended rules impose new requirements only on foreign brokers (who are not subject to § 1.35). Foreign brokers and other persons receiving a special call pursuant to § 21.02 are required by that regulation to furnish the information requested. Since such persons cannot comply with the legal requirement to furnish information pursuant to a special call without maintaining records from which to generate the information requested, it follows that persons subject to special calls under § 21.02 are required, by the Commission's regulations, to maintain such records. Therefore, such records—including both those previously listed in § 21.02, and those that are added by this rule amendment—are subject to the five-year record retention requirements of § 1.31(a)(1) of the regulations, which provides in relevant part that: All books and records required to be kept by the Act or by these regulations shall be kept for a period of five years from the date thereof and shall be readily accessible during the first two years of the five-year period. B. Delegation of Authority The amendments adopted herein also delegate to the Director of the Division of Market Oversight, and the Director's delegatees, the power to issue special calls pursuant to sections 21.01 and 21.02. Consistent with other delegations of authority to Commission senior staff, the delegation of the Part 21 special call authority allows the Director to submit to the Commission for its consideration any matter that has been delegated pursuant to the new section. The amendment also preserves the Commission's ultimate authority over the special calls by providing that, “nothing in this section shall be deemed to prohibit the Commission, at its election, from exercising the authority delegated * * * to the Director.” C. The Proposed Rules These amendments were published for comment at 72 FR 34417, June 22, 2007, with a 30-day comment period. No comments were received in response to the notice of proposed rulemaking. Accordingly, the amendments have been adopted as proposed. II. Cost Benefit Analysis Section 15 of the Act, as amended by section 119 of the CFMA, requires the Commission to consider the costs and benefits of its action before issuing a new regulation or order under the Act. By its terms, § 15(a) does not require the Commission to quantify the costs and benefits of its action or to determine whether the benefits of the action outweigh its costs. Rather, § 15(a) simply requires the Commission to “consider the costs and benefits” of the subject rule or order. Section 15(a) further specifies that the costs and benefits of the proposed rule or order shall be evaluated in light of five broad areas of market and public concern:
(1)Protection of market participants and the public;
(2)efficiency, competitiveness, and financial integrity of futures markets;
(3)price discovery;
(4)sound risk management practices; and
(5)other public interest considerations. The Commission may, in its discretion, give greater weight to any one of the five enumerated areas of concern and may, in its discretion, determine that, notwithstanding its costs, a particular rule or order is necessary or appropriate to protect the public interest or to effectuate any of the provisions or to accomplish any of the purposes of the Act. The amendments supplement the Commission's rules regarding its market surveillance program. That program supports one of the Commission's most critical statutory responsibilities, deterring and preventing price manipulation or any other disruptions to market integrity. Effective surveillance activities are crucial not only to protecting market participants and the public from price manipulation, but also to: Promoting market efficiency, competitiveness and financial integrity; protecting the futures markets' price discovery function; and promoting sound risk management practices. In addition, the records that are subject to special call under these amendments are the type of basic transaction records that any foreign broker would create as a matter of sound business practices. Because these records would be created in any event, independently of any regulatory requirements, the rules impose no additional costs on foreign brokers in that area. There would be minimal costs associated with providing the records in answer to a special call, but such costs would be far outweighed by the benefits of protecting the markets and the public. Finally, with respect to the five-year record retention requirement that applies to these records, the cost of retaining the records will be minimal because Commission rules allow such records to be maintained electronically. Those minimal costs would, again, be far outweighed by the benefits of protecting the marketplace and the public. The Commission has considered the costs and benefits of the amendments to Part 21 regarding special calls in light of the above-noted specific areas of concern identified in section 15. The Commission believes that the amended rules impose the minimum requirements necessary to enable it to perform its oversight functions and to carry out its mandate to protect the public interest in markets that are free of fraud, abuse and manipulation. After considering these factors, the Commission has determined to adopt the rule amendments set forth below. In the notice of proposed rulemaking, the Commission specifically invited public comment on its application of the criteria contained in the Act. Commenters were also invited to submit any quantifiable data that they might have concerning the costs and benefits of the proposed rules with their comment letter. As noted above, no comments were received. III. Related Matters A. Regulatory Flexibility Act The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601 *et seq.* , requires federal agencies, in promulgating rules, to consider the impact of those rules on small entities. The amendment to § 21.02 applies to FCMs, IBs, members of contract markets and foreign brokers. However, as noted above, the first three of these categories are already subject to substantial reporting and recordkeeping requirements under § 1.35 of the Commission's regulations. Among other things, that section requires FCMs, IBs and contract market members to maintain, and produce on request, the records that are also the subject of these rules. Therefore, as a practical matter, the rules impose new requirements only on foreign brokers (who are not subject to § 1.35). With respect to such foreign brokers, the Commission recently published proposed rules to exempt from registration certain foreign persons (including foreign brokers). 3 In reviewing the applicability of the RFA to such foreign persons, the Commission noted that it has previously established certain definitions of “small entities” to be used in evaluating the impact of its regulations on such entities in accordance with the RFA. 4 The Commission has previously determined that FCMs are not small entities for purposes of the RFA because each FCM has an underlying fiduciary relationship with its customers, regardless of the size of the FCM. 5 The Commission notes that the foreign brokers affected by these amendments to the Commission's regulations would be required to be registered as FCMs if not for certain exemptions provided in Commission regulations. As such, they would maintain a fiduciary relationship with customers similar to the relationship maintained by each registered FCM. Therefore, in this context foreign brokers, like FCMs, are not appropriately categorized as small entities. Accordingly, the Acting Chairman, on behalf of the Commission, hereby certifies pursuant to 5 U.S.C. 605(b) that the rules will not have a significant economic impact on a substantial number of small entities. 3 72 FR 15673 (April 2, 2007). 4 47 FR 18618, at 18621 (April 30, 1982). 5 *Id.* at 18619. B. Paperwork Reduction Act These rules contain information collection requirements. As required by the Paperwork Reduction Act of 1995 (“PRA”), 6 the Commission submitted a copy of the rules to the Office of Management and Budget (“OMB”) for its review. 6 Pub. L. 104-13 (May 13, 1995). The amended rules have been reviewed and approved by OMB pursuant to the PRA, under control number 3038-0009. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number. In the Notice of Proposed Rulemaking, the Commission estimated the paperwork burden that could be imposed by the amendments and solicited comments thereon. 7 No comments were received. 7 72 FR 34417 (June 22, 2007). Copies of the information collection submission to OMB are available from the Commission Clearance Officer, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581,
(202)418-5160. List of Subjects Commodity futures, Commodity Futures Trading Commission. In consideration of the foregoing, and pursuant to the authority in the Commodity Exchange Act, the Commission hereby amends Part 21 of Title 17 of the Code of Federal Regulations as follows: PART 21—SPECIAL CALLS 1. The authority section for Part 21 continues to read as follows: Authority: 7 U.S.C. 1a, 2, 2a, 4, 6a, 6c, 6f, 6g, 6i, 6k, 6m, 6n, 7, 7a, 12a, 19 and 21; 5 U.S.C. 552 and 552(b). 2. Section 21.02 is amended by removing the word, “and,” at the end of paragraph (f), by redesignating paragraph
(g)as paragraph (i), and by adding new paragraphs
(g)and (h). The additions read as follows: § 21.02 Special calls for information on open contracts in accounts carried or introduced by futures commission merchants, members of contract markets, introducing brokers, and foreign brokers.
(g)The total number of futures contracts exchanged for commodities or for derivatives positions;
(h)The total number of futures contracts against which delivery notices have been issued or received; and 3. Section 21.04 is added to read as follows: § 21.04 Delegation of authority to the Director of the Division of Market Oversight. The Commission hereby delegates, until the Commission orders otherwise, to the Director of the Division of Market Oversight, or to the Director's delegates, the authority set forth in section 21.01 of this Part to make special calls for information on controlled accounts from futures commission merchants and from introducing brokers and the authority set forth in section 21.02 of this Part to make special calls for information on open contracts in accounts carried or introduced by futures commission merchants, members of contract markets, introducing brokers, and foreign brokers. The Director may submit to the Commission for its consideration any matter that has been delegated pursuant to this section. Nothing in this section shall be deemed to prohibit the Commission, at its election, from exercising the authority delegated in this section to the Director. Issued in Washington, DC, on August 23, 2007, by the Commission. David Stawick, Secretary of the Commission. [FR Doc. E7-17100 Filed 8-30-07; 8:45 am] BILLING CODE 6351-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 53 and 54 [TD 9334] RIN 1545-BG95 Requirement of Return and Time for Filing; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction notice. SUMMARY: This document contains a correction to final and temporary regulations (TD 9334) that were published in the **Federal Register** on Friday, July 6, 2007 (72 FR 36871) providing guidance relating to the requirement of a return to accompany payment of excise taxes under section 4965 of the Internal Revenue Code and the time for filing that return. DATES: The correction is effective August 31, 2007. FOR FURTHER INFORMATION CONTACT: Galina Kolomietz,
(202)622-6070, Michael Blumenfeld,
(202)622-1124, or Dana Barry,
(202)622-6060 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Background The final and temporary regulations that are the subject of the correction are under Section 4965 of the Internal Revenue Code. Need for Correction As published, final and temporary regulations (TD 9334) contain an error that may prove to be misleading and is in need of clarification. Correction of Publication Accordingly, the publication of the final and temporary regulations (TD 9334), which were the subject of FR Doc. E7-12901, is corrected as follows: On page 36781, in the document heading, the language “RIN 1545-BG20” is corrected to read “RIN 1545-BG95”. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration). [FR Doc. E7-17227 Filed 8-30-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. CGD05-07-046] RIN 1625-AA08 Special Local Regulations for Marine Events; Choptank River, Cambridge, MD AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing temporary special local regulations during the “Cambridge Offshore Challenge,” a marine event to be held on the waters of the Choptank River at Cambridge, Maryland. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in the Choptank River during the event. DATES: This rule is effective from 10:30 a.m. on September 22, 2007 through 5:30 p.m. on September 23, 2007. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket CGD05-07-046 and are available for inspection or copying at Commander (dpi), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, Room 416 between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Mr. Ronald Houck, Marine Event Coordinator, Coast Guard Sector Baltimore, at
(410)576-2674 or e-mail at *Ronald.L.Houck@uscg.mil.* SUPPLEMENTARY INFORMATION: Regulatory Information On July 16, 2007, we published a notice of proposed rulemaking
(NPRM)entitled Special Local Regulations for Marine Events; Choptank River, Cambridge, MD in the **Federal Register** (72 FR 38804). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support vessels, spectator craft and other vessels transiting the event area. However, advance notifications will be made to users of Choptank River via marine information broadcasts, local notice to mariners, commercial radio stations, and area newspapers. Background and Purpose On September 22 and 23, 2007, the Chesapeake Bay Powerboat Association will sponsor the “2007 Cambridge Offshore Challenge,” on the waters of the Choptank River at Cambridge, Maryland. The event will consist of approximately 60 offshore powerboats conducting high-speed competitive races between the Route 50 Bridge and Oystershell Point, MD. A fleet of approximately 250 spectator vessels is expected to gather nearby to view the competition. Due to the need for vessel control during the event, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels. Discussion of Comments and Changes The Coast Guard did not receive comments in response to the notice of proposed rulemaking
(NPRM)published in the **Federal Register** . Accordingly, the Coast Guard is establishing temporary special local regulations on specified waters of the Choptank River, near Cambridge, Maryland. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. Although this regulation will prevent traffic from transiting a portion of the Choptank River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect. Extensive advance notifications will be made to the maritime community via Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly. Additionally, the regulated area has been narrowly tailored to impose the least impact on general navigation yet provide the level of safety deemed necessary. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Choptank River during the event. This rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the Fifth Coast Guard District at the address listed under ADDRESSES . The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. We have made a determination that this action is not likely to have a significant effect on the human environment. The proposed marine event consisting of power boats conducting high speed races along a marked race course within the Choptank River does not introduce any significant environmental impacts in the area of the event and/or adjacent waterways. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. Add a temporary § 100.35-T05-046 to read as follows: § 100.35-T05-046 Choptank River, Cambridge, MD.
(a)*Definitions:*
(1)*Coast Guard Patrol Commander* means a commissioned, warrant, or petty officer of the Coast Guard who has been designated by the Commander, Coast Guard Sector Baltimore.
(2)*Official Patrol* means any vessel assigned or approved by Commander, Coast Guard Sector Baltimore with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.
(3)*Participant* includes all vessels participating in the 2007 Cambridge Offshore Challenge under the auspices of the Marine Event Permit issued to the event sponsor and approved by Commander, Coast Guard Sector Baltimore.
(b)*Regulated area* includes all waters of the Choptank River, from shoreline to shoreline, bounded to the west by the Route 50 Bridge and bounded to the east by a line drawn along longitude 076° W, between Goose Point, MD and Oystershell Point, MD. All coordinates reference Datum: NAD 1983.
(c)*Special local regulations:*
(1)Except for event participants and persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.
(2)The operator of any vessel in the regulated area must:
(i)Stop the vessel immediately when directed to do so by any Official Patrol.
(ii)Proceed as directed by any Official Patrol.
(iii)When authorized to transit the regulated area, all vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the race course.
(d)*Enforcement period.* This section will be enforced from 10:30 a.m. on September 22, 2007 to 5:30 p.m. on September 23, 2007. Dated: August 23, 2007. Fred M. Rosa, Jr., Rear Admiral, U.S. Coast Guard Commander, Fifth Coast Guard District. [FR Doc. E7-17337 Filed 8-30-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. COTP San Francisco Bay 07-038] Special Local Regulations for Marine Events; San Francisco Bay Navy Fleet Week Parade of Ships and Blue Angels Demonstration, San Francisco Bay, CA AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce the special local regulations in the navigable waters of San Francisco Bay for the annual U.S. Navy and City of San Francisco sponsored Fleet Week Parade of Navy Ships and Blue Angels Flight Demonstration to be held on October 4, 2007, through October 7, 2007. This action is necessary to ensure the safety of event participants and spectators. During the enforcement period, no persons or vessels may enter the regulated area without permission of the Captain of the Port
(COTP)or his designated representative. DATES: The regulations in 33 CFR 100.1105(b)(1), regulated area “Alpha” for Navy Parade of Ships, will be enforced from 11:30 a.m. to 1 p.m. on October 6, 2007. The regulations in 33 CFR 100.1105(b)(2), regulated area “Bravo” for the U.S. Navy Blue Angels Activities, will be enforced from 11:30 a.m. to 5 p.m. on October 4, 2007, and 12:30 p.m. to 5 p.m. on October 5, 2007, through October 7, 2007. If the U.S. Navy Blue Angels Activities are delayed by inclement weather, the regulation will also be enforced on October 8, 2007, from 12:30 p.m. to 5 p.m. FOR FURTHER INFORMATION CONTACT: Lieutenant Eric Ramos, Waterways Safety Branch, U.S. Coast Guard Sector San Francisco, at
(415)556-2950 extension 143, or the Sector San Francisco Command Center, at
(415)399-3547. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special local regulation for the annual San Francisco Bay Navy Fleet Week Parade of Ships and Blue Angels Demonstration in 33 CFR 100.1105; the Navy Parade of Ships will be enforced from 11:30 a.m. to 1 p.m. on October 6, 2007; and the U.S. Navy Blue Angels Activities will be enforced from 11:30 a.m. to 5 p.m. on October 4, 2007, and 12:30 p.m. to 5 p.m. on October 5, 2007, through October 7, 2007. If the U.S. Navy Blue Angels Activities are delayed by inclement weather, the regulation will also be enforced on October 8, 2007, from 12:30 p.m. to 5 p.m. These regulations can also be found in the October 1, 1993, issue of the **Federal Register** 58 FR 51242. Under the provisions of 33 CFR 100.1105 a vessel may not enter the regulated area, unless it receives permission from the COTP. Additionally, no person or vessel may enter or remain within 500 yards ahead of the lead Navy parade vessel, within 200 yards astern of the last parade vessel, and within 200 yards on either side of all parade vessels. No person or vessel shall anchor, block, loiter in, or impede the transit of ship parade participants or official patrol vessels. When hailed by U.S. Coast Guard patrol personnel by siren, radio, flashing light, or other means, a person or vessel shall come to an immediate stop. Persons or vessels shall comply with all directions given. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation. This notice is issued under authority of 33 CFR 100.1105 and 5 U.S.C 552(a). In addition to this notice in the **Federal Register** , the Coast Guard will provide the maritime community with extensive advance notification of this enforcement period via the Local Notice to Mariners, and Broadcast Notice to Mariners. Dated: 20 August 2007. W.J. Uberti, Captain, U.S. Coast Guard, Captain of the Port, San Francisco. [FR Doc. E7-17340 Filed 8-30-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 418 [CMS-1539-F] RIN 0938-AO72 Medicare Program; Hospice Wage Index for Fiscal Year 2008 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule sets forth the hospice wage index for fiscal year 2008. This final rule also revises the methodology for updating the wage index for rural areas without hospital wage data and provides clarification of selected existing Medicare hospice regulations and policies. EFFECTIVE DATES: These regulations are effective on October 1, 2007. FOR FURTHER INFORMATION CONTACT: Terri Deutsch,
(410)786-9462. SUPPLEMENTARY INFORMATION: I. Background A. General 1. Hospice Care Hospice care is an approach to treatment that recognizes that the impending death of an individual warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, social, psychological, emotional, and spiritual services through use of a broad spectrum of professional and other caregivers, with the goal of making the individual as physically and emotionally comfortable as possible. Counseling services and inpatient respite services are available to the family of the hospice patient. Hospice programs consider both the patient and the family as a unit of care. Section 1861(dd) of the Social Security Act (the Act) provides for coverage of hospice care for terminally ill Medicare beneficiaries who elect to receive care from a participating hospice. Section 1814(i) of the Act provides payment for Medicare participating hospices. 2. Medicare Payment for Hospice Care Our regulations at 42 CFR part 418 establish eligibility requirements, payment standards and procedures, define covered services, and delineate the conditions a hospice must meet to be approved for participation in the Medicare program. Part 418 subpart G provides for payment in one of four prospectively-determined rate categories (routine home care, continuous home care, inpatient respite care, and general inpatient care) to hospices, based on each day a qualified Medicare beneficiary is under a hospice election. B. Hospice Wage Index Our regulations at § 418.306(c) require each hospice's labor market to be established using the most current hospital wage data available, including any changes to the Metropolitan Statistical Areas
(MSAs)definitions, which have been superseded by Core-Based Statistical Areas (CBSAs). The hospice wage index is used to adjust payment rates for hospice agencies under the Medicare program to reflect local differences in area wage levels. The original hospice wage index was based on the 1981 Bureau of Labor Statistics hospital data and had not been updated since 1983. In 1994, because of disparity in wages from one geographical location to another, a committee was formulated to negotiate a wage index methodology that could be accepted by the industry and the government. This committee, functioning under a process established by the Negotiated Rulemaking Act of 1990, was comprised of: National hospice associations; rural, urban, large and small hospices; multi-site hospices; consumer groups; and a government representative. On April 13, 1995, the Hospice Wage Index Negotiated Rulemaking Committee signed an agreement for the methodology to be used for updating the hospice wage index. In the August 8, 1997 **Federal Register** (62 FR 42860), we published a final rule implementing a new methodology for calculating the hospice wage index based on the recommendations of the negotiated rulemaking committee. The committee statement was included in the appendix of that final rule (62 FR 42883). The hospice wage index is updated annually. Our most recent annual update notice, published in the September 1, 2006 **Federal Register** (71 FR 52080), set forth updates to the hospice wage index for FY 2007. On October 3, 2006, we published a correction notice in the **Federal Register** (71 FR 58415) and we published a subsequent correction notice on January 26, 2007 (72 FR 3856), to correct technical errors that appeared in the September 1, 2006 notice. 1. Changes to Core-Based Statistical Areas The annual update to the hospice wage index is published in the **Federal Register** and is based on the most current available hospital wage data, as well as any changes by the Office of Management and Budget
(OMB)to the definitions of MSAs. The August 4, 2005 final rule (70 FR 45130) adopted the changes discussed in the OMB Bulletin No. 03-04 (June 6, 2003), which announced revised definitions for Micropolitan Statistical Areas and the creation of MSAs and Combined Statistical Areas. In adopting the OMB Core-Based Statistical Area
(CBSA)geographic designations, we provided for a 1-year transition with a blended wage index for all providers for FY 2006. For FY 2006, the hospice wage index for each provider consisted of a blend of 50 percent of the FY 2006 MSA-based wage index and 50 percent of the FY 2006 CBSA-based wage index. As discussed in the August 4, 2005 final rule and in the September 1, 2006 notice, for FY 2007 and subsequent years we will use the full CBSA-based wage index values, as presented in Tables A and B of this final rule for FY 2008. 2. Raw Wage Index Values Raw wage index values (that is, inpatient hospital pre-floor and pre-reclassified wage index values) as described in the August 8, 1997 hospice wage index final rule (62 FR 42860), are subject to either a budget neutrality adjustment or application of the wage index floor. Raw wage index values of 0.8 or greater are adjusted by the budget neutrality adjustment factor. Budget neutrality means that, in a given year, estimated aggregate payments for Medicare hospice services using the updated wage index values will equal estimated payments that would have been made for these services if the 1983 wage index values had remained in effect. To achieve this budget neutrality, the raw wage index is multiplied by a budget neutrality adjustment factor. The budget neutrality adjustment factor is calculated by comparing what we would have paid using current rates and the 1983 wage index to what would be paid using current rates and the new wage index. The budget neutrality adjustment factor is computed and applied annually. For the FY 2008 hospice wage index in the final rule, FY 2007 hospice payment rates were used in the budget neutrality adjustment factor calculation. Raw wage index values below 0.8 are adjusted by the greater of:
(1)The hospice budget neutrality adjustment factor; or
(2)the hospice wage index floor (a 15 percent increase) subject to a maximum wage index value of 0.8. For example, if County A has a pre-floor, pre-reclassified hospital wage index (raw wage index value) of 0.4000, we would perform the following calculations using the budget neutrality factor (which for this example is 1.060988) and the hospice wage index floor to determine County A's hospice wage index: Raw wage index value below 0.8 multiplied by the budget neutrality adjustment factor: (0.4000 × 1.060988 = 0.4244). Raw wage index value below 0.8 multiplied by the hospice wage index floor: (0.4000 × 1.15 = 0.4600). Based on these calculations, County A's hospice wage index would be 0.4600. 3. Hospice Payment Rates Section 4441(a) of the Balanced Budget Act of 1997
(BBA)amended section 1814(i)(1)(C)(ii) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the market basket index, minus 1 percentage point. Payment rates for FY 2008 will be updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs will be the market basket percentage for the fiscal year. Accordingly, the FY 2008 update to the payment rates for each of the four levels of care (routine home care, continuous home care, general inpatient care and inpatient respite care) will be the full market basket percentage increase for FY 2008. The rate update for FY 2008 is implemented through a separate administrative instruction and is not part of this rule. Historically, the rate update has been published through a separate administrative instruction issued annually in July to provide adequate time to implement necessary system changes and allow for provider notification. Providers determine their payment rates by applying the wage index in this rule to the labor portion of the published hospice rates. 4. Proxy for the Hospital Market Basket As discussed above, the hospice payment rates for fiscal years after 2002 are adjusted each year based upon the full hospital market basket percentage increase. In the FY 2007 update notice (72 FR 52082) published on September 1, 2006, we indicated that beginning in April 2006, with the publication of March 2006 data, the Bureau of Labor Statistic's (BLS's) Employment Cost Index
(ECI)began using a different classification system, the North American Industrial Classification System (NAICS), instead of the Standard Industrial Classification System (SIC), which no longer exists. The ECIs had been used as the data source for wages and salaries and other price proxies in the hospital market basket. In the FY 2007 update notice we noted that no changes would be made to the usage of the NAICS-based ECI; however, input was solicited on this issue. We received no comments. As a result, in the proposed rule we did not propose any changes. II. Provisions of the Proposed Regulation and Analysis of and Responses to Public Comments On May 1, 2007, we published a proposed rule in the **Federal Register** (72 FR 24116) that set forth the proposed hospice wage index for FY 2008. The following is a summary of each of the proposed provisions followed by our response to public comments. We received 19 timely items of correspondence, one from a physician, 6 from hospice providers, and 12 from associations. A. Annual Update to the Hospice Wage Index We did not propose any modifications to the hospice wage index methodology as described in the 1997 final rule (62 FR 42860). In accordance with our regulations and the agreement signed with other members of the Hospice Wage Index Negotiated Rulemaking Committee, we use the most current hospital data available to adjust for area wage differences. As noted above, payment rates for each of the four levels of care (routine home care, continuous home care, general inpatient care and inpatient respite care) are adjusted annually based upon the hospital market basket for that year and are promulgated through administrative instructions issued annually in July in order to allow for sufficient time for system changes and provider notification. We use the previous fiscal year's hospital wage index data to calculate the hospice wage index values. For the FY 2008 proposed and final hospice wage index values, we used the FY 2007 hospital pre-floor and pre-reclassified hospital wage data. This means that the hospital wage data used for the hospice wage index is not adjusted to take into account any geographic reclassification of hospitals including those in accordance with sections 1886(d)(B) or 1886(d)(10) of the Act. We also do not take into account reclassifications in accordance with section 508 of the MMA or the out-migration adjustment for hospitals (section 505 of the MMA). All hospice wage index values for FY 2008 are adjusted by either the FY 2008 budget neutrality adjustment factor or the wage index floor adjustment. For wage index values 0.8 or greater, the value is multiplied by the budget neutrality adjustment factor. Wage index values that are below 0.8, receive the greater of a 15 percent increase or the budget neutrality adjustment factor subject to a maximum wage index value of 0.8. In other words, the floor adjustment is the greater of the raw wage index value multiplied by the proposed budget neutrality adjustment factor or the raw wage index value for that area is multiplied by 15 percent subject to a maximum value of 0.8. Budget neutrality means that, in a given year, estimated aggregate payments for Medicare hospice services using the updated wage index will equal estimated payments that would have been made for the same services if the wage index adopted for hospices in 1983 had remained in effect. For a detailed discussion of the methodology used to compute the hospice wage index see the September 4, 1996 proposed rule (61 FR 46579) and the August 8, 1997 final rule (62 FR 42860). As indicated in the proposed rule, we did not propose any changes in the methodology used in calculating the hospice wage index values and we did not solicit comments. However, we received eight items of correspondence pertaining to future changes, the methodology for computing the wage index for Puerto Rico, the publication of the market basket update through administrative issuance, and the inadequacy of rural payment rates. *Comment:* We received two comments stating that any future changes proposed for hospice payments should follow the negotiated rulemaking process rather than notice and comment. The same commenters also expressed support for a more reasonable and consistent approach to constructing wage index adjustments for hospitals and post acute providers. The commenters also indicated that any changes in the wage index approach should require an extended transition period to prevent disruptive swings. *Response:* We thank the commenters for their suggestions and we will keep them under advisement as we analyze the need for future refinements. *Comment:* One commenter suggested that the hospice payment rates be published with the hospice wage index regulations as is done in other prospective payment systems. *Response:* As we discussed in the proposed rule, historically the payment rate updates have been promulgated through a separate administrative instruction or administrative issuance in July of each year to provide adequate time to implement necessary system changes. As the hospice wage index regulation is scheduled for publication at the end of August, inclusion of the hospice payment updates in this regulation would not allow sufficient time for system changes to be made to accommodate the October 1 implementation date of the payment updates. *Comment:* Several commenters noted that there are challenges in furnishing hospice care in rural areas, citing underdevelopment, long distances for staff to travel, staff recruitment challenges and the need for rural hospices to be competitive in the wages and benefits that they provide. One commenter stated that rural areas adjacent to urban areas are at a greater disadvantage as they are competing for staff in urban areas with higher wages. Another commenter stated that rural home based salary adjustment based on the hospital wage index is inadequate and should be reimbursed at a higher rate. The commenter also stated that there are extra costs for mileage expenses for rural staff and suggested that an “expansive geography index” be applied to the hospice wage index formula for rural counties. Another commenter indicated willingness to discuss this issue further to investigate ways to encourage hospice care in rural areas. *Response:* We thank the commenters for their comments and suggestions. We recognize that there are challenges in providing health care in urban as well as in rural areas. Recruitment challenges, competitiveness in wages and benefits and commuting difficulties are factors that are facing all health care providers. We believe that the hospital wage data reflects these factors and as a result, the hospice wage index values are also reflective of these challenges. In addition, the application of the hospice floor for raw values below 0.8 provides a higher wage index value to many rural areas. However, we will consider these comments and suggestions as we analyze the need for future refinements to the hospice payment methodology. *Comment:* One hospice provider from Puerto Rico provided us with a study that it had undertaken. It requested that this report be used by CMS to make the “right” decision about the correct wage index for Puerto Rico. This study concluded that 34 hospices in Puerto Rico will see a decrease in their hospice payments by 2.6 percent in FY 2008. Several of the conclusions presented in this study compare a hospice in Arecebo, Puerto Rico to hospitals in New England and Albuquerque, New Mexico, list the economic challenges in Puerto Rico, and suggested the payment rate that it believes should be used for Puerto Rico. *Response:* We thank the commenter for sending its study to us. However, as the study concludes that payment rates and wage index values should be determined utilizing the same methodology used for the hospital wage index values, we believe the study is based on an erroneous and incorrect understanding of the content of the hospice wage index proposed rule as well as the methodology that had been developed and agreed upon through the negotiated rulemaking committee. As noted above, the methodology for the hospice wage index was developed, and an agreement on the methodology was signed, by members of the Hospice Wage Index Negotiated Rulemaking Committee. We note that Puerto Rico was represented by the hospice associations' participants on the committee. Hospices in Puerto Rico had notice of the committee deliberations and they had an opportunity to apply to be on the committee, and were encouraged to attend and make a statement to the committee. A detailed description of the methodology is contained in both the September 4, 1996 proposed rule (61 FR 46579) and the August 8, 1997 final rule (62 FR 42860). The commenter is incorrect in stating that the payment rates for Puerto Rico will decrease 2.6 percent in FY 2008. We indicated in the proposed rule that the impact analysis demonstrates the impact of the FY 2008 wage index values and is not a projection of the anticipated expenditures of hospice payments for FY 2008. The impact analysis compares hospice payments using the FY 2007 hospice wage index to the estimated payments using the FY 2008 wage index. For urban Puerto Rico, the proposed rule indicated that, using the FY 2007 payment rates and the FY 2008 wage index values, payments are anticipated to decrease 2.6 percent, which represents only the affects of the wage index and does not reflect the payment increase for FY 2008. As noted above, the FY 2008 hospice payment rates will reflect the market basket update. We do not understand the study's comparison between Puerto Rico and Albuquerque, New Mexico or New England regions and as a result cannot respond. However, it is important to note that wage index values fluctuate from year to year for counties as well as regions and we do not believe that comparisons to other regions provide any substantive information. It is also important to note that the FY 2007 hospital pre-floor, pre-reclassified hospital wage data reflects data from the FY 2003 hospital cost reports and the data provided in the Puerto Rico study reflect data from later years. We will share the information provided in this study with the organizational component within CMS that develops the inpatient hospital wage data, as it appears that the study relates to the development of the hospital wage index. B. Rural Areas Without Hospital Wage Data When adopting OMB's new labor market designations, we identified some geographic areas where there were no hospitals, and thus, no hospital wage index data on which to base the calculation of the hospice wage index (70 FR 45135, August 4, 2005). For FY 2006 and FY 2007, we adopted a policy to use the FY 2005 pre-floor, pre-reclassified hospital wage index value for rural areas where no rural hospital wage data were available. We also adopted the policy that for urban labor markets without an urban hospital from which a hospital wage index data could be derived, all of the CBSAs within the State would be used to calculate a statewide urban average wage index data to use as a reasonable proxy for these areas. In the August 2005 final rule and in the September 2006 update notice, we applied the average wage index data from all urban areas lacking hospital wage data in that state. Currently, the only CBSA that is affected by this policy is CBSA 25980, Hinesville-Fort Stewart, Georgia. We proposed to continue this approach for urban areas where there are no hospitals and, thus, no hospital wage index data on which to base the calculations for the FY 2008 and subsequent hospice wage indexes. In the proposed rule we noted that under the CBSA labor market areas, there are no rural hospitals in rural locations in Massachusetts and Puerto Rico. In the August 2005 final rule (70 FR 45135) and in the September 2006 update notice (71 FR 52081), we applied the FY 2005 pre-floor, pre-reclassified hospital wage data in both FY 2006 and FY 2007 for rural Massachusetts and rural Puerto Rico. In the proposed rule, we considered alternatives in our methodology to update the wage index for rural areas without hospital wage index data consistent with other prospective payment systems. We noted that we believe that the best imputed proxy for rural areas, would:
(1)Use pre-floor, pre-reclassified hospital data;
(2)use the most local data available to impute a rural wage index;
(3)be easy to evaluate and;
(4)be easy to update from year to year. Although our current methodology meets the first three criteria, it could not be easily updated from year to year because the FY 2005 pre-floor, pre-reclassified hospital wage data would continue to be used. Therefore, in cases where there is a rural area without rural hospital wage data, we proposed using the average pre-floor, pre-reclassified wage index data from all contiguous CBSAs to represent a reasonable proxy for the rural area. This approach meets all of the stated criteria (72 FR 24118). We noted in the proposed rule that we interpret the term “contiguous” to mean “sharing a border”. We cited the example of Massachusetts, where the entire rural area consists of Dukes and Nantucket counties. We determined that the borders of Dukes and Nantucket counties are contiguous with Barnstable and Bristol counties. Therefore, the pre-floor, pre-reclassified wage index values for the counties of Barnstable (CBSA 12700, Barnstable Town, MA) and Bristol (CBSA 39300, Providence-New Bedford-Fall River, RI-MA) would be averaged resulting in an imputed pre-floor, pre-reclassified rural wage index for rural Massachusetts. While we believe that this policy could be readily applied to other rural areas that lack hospital wage data (possibly due to hospitals converting to a different provider type, such as a critical access hospital (CAH), that do not submit the appropriate wage data), should a similar situation arise in the future, we may re-examine this policy. In the proposed rule we noted that we do not believe that this policy would be appropriate for Puerto Rico. There are sufficient economic differences between hospitals in the United States and those in Puerto Rico, including the payment of hospitals in Puerto Rico using blended Federal/Commonwealth-specific rates that we believe necessitate a separate and distinct policy for Puerto Rico. Consequently, any alternative methodology for imputing a wage index for rural Puerto Rico would need to take into account those differences. Our policy of imputing a rural wage index based on the wage index(es) of CBSAs contiguous to the rural area in question does not recognize the unique circumstances of Puerto Rico. We also noted that while we have not yet identified an alternative methodology for imputing a wage index for rural Puerto Rico, we will continue to evaluate the feasibility of using existing hospital wage data and, possibly, wage data from other sources. Accordingly, we propose to continue using the most recent pre-floor, pre-reclassified wage index previously available for Puerto Rico, which is 0.4047 (72 FR 24118-19). *Comment:* We received four items of correspondence in response to our proposal for rural areas without hospital wage data. Two commenters supported the proposal. Two commenters stated that the proposed methodology, while not ideal, comes closest to what the commenters believe is an equitable solution in resolving a perceived flaw in using hospital data to adjust payment to non-hospital providers. The commenters also assumed that a better alternative would emerge over the next few years in the course of revising the hospital wage index. One commenter agreed with the methodology but asked that we do not use this formula for other situations without review and reexamination of the policy. The same commenter commended us for demonstrating flexibility and good judgment in creating a different system for Massachusetts and Puerto Rico. We note that we received no comments on the methodology employed for urban areas without a hospital from which to derive hospital wage data. *Response:* We thank the commenters for their support. We continue to believe that our proposed methodology results in the most appropriate imputed proxy for rural areas in meeting the criteria we identified as follows:
(1)Use pre-floor, pre-re-classified hospital data,
(2)use the most local data available to impute a rural wage index,
(3)be easy to evaluate; and
(4)be easy to update from year to year. We will consider the suggestion for evaluating the policy if needed in other situations. C. Nomenclature Changes We proposed to clarify that all hospice rules and notices are considered to incorporate the CBSA changes published in the most recent OMB bulletin that applies to the hospital wage index data used to determine the current hospice wage index (72 FR 24119). We received no comments on this proposal. D. Payment for Hospice Care Based on the Location Where Care Is Furnished Under the Medicare hospice program, hospice providers receive payment for four levels of care based upon the individual's needs. The payment rates are adjusted to reflect the variation in geographic locations. Section 4442 of the BBA amended section 1814(i)(2) of the Act, effective for services furnished on or after October 1, 1997, required the application of the local wage index value of the geographic location at which the service is furnished for hospice care provided in the home. Prior to this provision, local wage index values were applied based on the geographic location of the hospice provider, regardless of where the hospice care was furnished. In the proposed rule, we noted that we believe that for the majority of hospice providers the office and the site for the provision of home and inpatient care occur in the same geographic area. However, with the substantial growth of hospice providers in multiple states and with multiple sites within a State, hospice providers have been able to inappropriately maximize reimbursement by locating their offices in high-wage areas and delivering services in a lower-wage area. We also believe that hospice providers are able to inappropriately maximize reimbursement by locating their inpatient services either directly or under contractual arrangements in lower wage areas than their offices. Section 4442 of the BBA applies the wage index value of a home's geographic location for services provided there, but is silent as to what wage index value should be used for hospice services provided in an inpatient setting. We believe that the application of the wage index values should reflect the location of the services provided rather than the location of an office. We believe such application results in a reimbursement rate that is a more accurate reflection of the wages paid by the hospice for the staff used to furnish care. We proposed that effective January 1, 2008, all payment rates (routine home care, continuous home care, inpatient respite and general inpatient care) be adjusted by the geographic wage index value of the area where hospice services are provided. This would require hospice providers to include the geographic location of the inpatient facility for general inpatient and inpatient respite levels of care on claims submitted for payment. We proposed to modify § 418.302 accordingly. In the proposed rule we also indicated that as hospice claims do not contain information identifying the location of the facility where general inpatient and respite care are provided, we are unable to predict the savings or costs associated with the changes associated with this proposed provision. However, we believe most hospice providers provide hospice care in the same geographic location as their offices. Therefore, we believe the impact of implementing this proposal will be negligible. *Comment:* We received eight items of correspondence, of which six supported the provision to base payment rates on the geographic wage index value of the area where inpatient hospice services are provided. *Response:* We thank the commenters for their support of this provision. *Comment:* One commenter suggested that we suspend the implementation of this provision until we have additional data from providers on the impact. *Response:* In the proposed rule we indicated that, as hospice claims do not contain information identifying the location of the facility where inpatient care is provided, we are unable to predict the savings or costs associated with changes in this provision. Effective January 1, 2007, hospice providers were required to indicate the type of location where care was provided (for example, nursing home, assisted living facility, hospital unit), but not the geographic location (which would be used to adjust payments). As we have indicated, we believe that for most providers, the location of the inpatient facility and the hospice provider are the same. We do not believe that postponing the implementation of this provision would enable us to collect any additional information. *Comment:* One commenter indicated that this change will significantly increase the complexity of filing hospice claims and will increase hospice costs due to the need to include the CBSA for the geographic location, as well as the code of where the patient is receiving hospice services. *Response:* We appreciate the concern regarding the complexity of filing claims and the perceived increased costs to hospices. We are in the process of developing operational instructions that we believe will help simplify the billing process. Hospice providers currently are required to identify the geographic location of their patients for the routine home care and continuous home care levels of care, and the location of the hospice office for general inpatient care and inpatient respite care. We are now also requiring hospice providers to identify the geographic location where inpatient care is provided. We believe that for the majority of hospice providers, the location of the facility for the provision of both the general inpatient and inpatient respite levels of care will be the same as the location of the hospice office. For those majority of cases, this change will require the hospice provider to indicate the same CBSA location of the office on the claims as the location of the facility where inpatient levels of care are provided. As a result, we believe that the impact on hospices for implementing this provision should be negligible as most hospices currently provide this information on the claims. *Comment:* Several commenters concurred with the provision but objected to the statement that hospice providers are able to inappropriately maximize reimbursement by having their offices located in a higher wage area. One commenter indicated that the statement was misleading and unnecessarily harsh. Another commenter suggested removing the statement. One commenter interpreted this statement as being demeaning and inflammatory. The same commenter stated that most hospices would not benefit from manipulating the location of an inpatient facility. Several commenters indicated that there is nothing prohibiting a hospice from having their inpatient facilities in a higher wage area, though the commenters stated it was doubtful that a hospice would do this or arrange contracts in order to manipulate reimbursement. Some commenters stated that urban areas have higher rates and that hospices generally have contracts with all hospitals in an area. Some commenters indicated patients have choices about where to receive care and would complain if they were forced to receive inpatient care out of their area. *Response:* While we appreciate the commenters objection to the statement that we made about hospice providers being able to inappropriately maximize reimbursement by locating their offices in a higher age area, we concur with the commenter that nothing prohibits a hospice from locating its inpatient services, either directly or under contractual arrangements, in a higher wage area, as well. In fact, we have received anecdotal information that leads us to believe that there are hospice offices that have been intentionally located in higher wage areas than those of their patients in order to maximize their reimbursement. We supported our proposal by noting the potential for maximizing reimbursement based on the location of the main office, which was the same rationale used by the congressional committee when the BBA 1997 provision requiring the application of the local wage index of the geographic location where the service is furnished for hospice care provided in the home was enacted. We believe that the same rationale applies to the inpatient facility locations as well. Our intent for this provision is to have all levels of payment adjusted by the wage index that applies to the site where the service is being provided. *Comment:* One commenter interpreted the proposed provision as reducing reimbursement to a lesser amount based on distance from the main office. The same commenter stated that staff were paid at the home office area rate and suggested that payment be based on the costs at the main office. *Response:* We believe that the suggestion that using distance from the main office determines payment rates is a misinterpretation of the intent of this provision as well as the statement concerning maximizing reimbursement based upon the location of the hospice main office. As we have discussed in the proposed rule, we were not proposing to modify the methodology used for computing the hospice wage index values. The intent of the proposal is to employ the same methodology for applying the wage index value for geographic variations regardless of where hospice care is provided. E. Educational Requirements for Nurse Practitioners On December 8, 2003, the Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act
(MMA)of 2003 (Pub. L. 108-173). Section 408 of the MMA, Recognition of Attending Nurse Practitioners as Attending Physicians to Serve Hospice Patients, amended sections 1861(dd)(3)(B) and 1814(a)(7) of the Act to add nurse practitioners
(NPs)to the definition of an attending physician for beneficiaries who have elected the hospice benefit. Section 408 of the MMA was implemented through an administrative issuance (Change Request
(CR)3226, Transmittals 22 and 304, September 24, 2004). In the August 4, 2005 FY 2006 final rule (70 FR 45139), we revised § 418.3 to reflect that an attending physician can be a nurse practitioner who meets the training, education and experience requirements as the Secretary may prescribe. We indicated in the proposed rule that we believe that the definition of attending physician, which includes nurse practitioners under the Medicare hospice benefit, should be consistent with the provisions of section 410.75 that provide for Medicare Part B coverage of nurse practitioner services. Therefore, to ensure consistency, we proposed to revise the definition of “attending physician” at § 418.3(1)(ii) to cross reference the training, education, and experience requirements as described in § 410.75(b). *Comment:* We received six items of correspondence regarding our proposal to conform the educational requirements for nurse practitioners serving as the attending physician to the requirements described in § 410.75. All commenters supported this provision. One commenter requested that the hospice physician definition be revised to include nurse practitioners, although the commenter recognized that any such revision could not allow nurse practitioners to certify the terminal illness of a patient. Another commenter suggested that the definition of attending physician be clarified by using the term “attending nurse practitioner” instead of referring to nurse practitioners as “attending physicians.” One commenter requested that the nurse practitioner qualifications provisions at § 410.75 be amended to reflect current and evolving educational requirements for advanced practice registered nurses. The commenter requested that the term “master's degree” in § 410.75(b)(ii)(4) be replaced with “graduate degree” to reflect nurse practitioners with doctoral degrees. *Response:* We thank the commenters for their support of this provision. As noted in the proposed rule and earlier in this rule, the implementation of section 408 of the MMA, which amended sections 1861(dd)(3)(B) and 1814(a)(7) of the Act to add nurse practitioners to the definition of an attending physician, was discussed in the August 4, 2005 final rule (70 FR 45130). Section 418.304(e)(2)(iv) specifies that nurse practitioners may bill and receive payment for services provided as the attending physician, only if the services are not related to the certification of the terminal illness in § 418.22(c)(1)(ii). Section 418.22(c) specifies that certification of the terminal illness is obtained from “the medical director of the hospice or the physician member of the hospice interdisciplinary group”. Therefore, we believe it would be inconsistent with statute and regulations to allow nurse practitioners to bill and receive payment for certifying an individual's terminal illness. As the role of the nurse practitioner is explicit in statute, nurse practitioners are not included as a hospice physician and may not serve in that role. We concur with the commenter that the definition of attending physician should use the term “attending nurse practitioner”. However, as the statute at sections 1861(dd)(3)(B) and § 1814(a)(7) explicitly uses the term “attending physician” for a nurse practitioner serving as the attending physician, we do not accept this recommendation. We did not propose to replace the term master's degree in 410.75(b)(ii)(4) with “graduate degree”. Therefore, we will not make the change in this final rule. However, we will provide your suggestion to the area within CMS responsible for advanced practitioner educational requirements. F. Caregiver Breakdown and General Inpatient Care In the proposed rule, we discussed a concern that some hospice providers are requesting payment for the general inpatient level of care for circumstances that do not qualify under the statute at section 1861(dd)(1)(G) of the Act, our regulations at § 418.202(e), or Medicare hospice policy in Chapter 9 of the Medicare Benefit Policy Manual. We provided clarification of existing statute, regulation and policy in the proposed rule and did not propose any changes (72 FR 24120). As discussed in the proposed rule, the Medicare hospice benefit places emphasis on the provision of items and services to enable an individual to remain at home in the company of family and friends. Section 1861(dd)(1)(G) of the Act provides for short-term inpatient hospice care to be available when an individual's pain and symptoms must be closely monitored or the intensity of interventions that are required cannot be provided in any other settings. Inpatient respite care is available for family members, who serve as the primary caregivers, to obtain rest for a period of no more than 5 days at a time. Hospice providers should submit claims for inpatient respite care in situations where there is an unexpected loss of the individual's support structure that results in an inability to maintain the individual in his or her home, but the individual does not require an inpatient level of care. Medicare policy states that skilled nursing care may be required by a patient whose home support has broken down, if this breakdown makes it no longer feasible to furnish needed care in the home setting. If the hospice and the caregiver, working together, are no longer able to provide the necessary skilled nursing care in the individual's home, and if the individual's pain and symptom management can no longer be provided at home, then the individual may be eligible for a short term general inpatient level of care. To receive payment for general inpatient care under the Medicare hospice benefit, beneficiaries *must* require an intensity of care directed towards pain control and symptom management that cannot be managed in any other setting. It is the level of care provided to meet the individual's needs and not the location of where the individual resides, or caregiver breakdown, that determine payment rates for Medicare services. Caregiver breakdown is the loss of the individual's support structure and should not be confused with the coverage requirements for medically reasonable and necessary care for pain and symptom management that cannot be managed in any other setting. Therefore, caregiver breakdown should not be billed as general inpatient care unless the coverage requirements for this level of care are met. As discussed above, for the general inpatient level of care, the intensity of interventions required for pain and symptom management is such that it cannot be provided in any setting other than an inpatient setting. As explained in the proposed rule, this is a clarification of current Medicare policy and as such does not create new limitations on access to hospice care. As noted in the proposed rule, we intend to monitor the usage of general inpatient care. Additionally, the circumstances addressed by this policy, and the clarification discussed above, should not be construed as similar to situations where an individual does not have family, friends or other individuals who are able to take on the role of a caregiver when a hospice election is made. In the proposed rule, we indicated that inpatient respite care could be used in situations where there is caregiver breakdown. However, in situations where there is a lack of a caregiver at the time of the election, the inpatient respite level of care does not apply. Inpatient respite care is unavailable when there is no caregiver to whom relief must be provided. The established policy that the level of care required to provide pain and symptom management determines payment and not the location of where the individual resides or receives hospice services, also applies in situations where there is not an appropriate caregiver. We recognize the difficulties surrounding the provision of hospice care to an individual who is terminally ill and who does not have caregivers at home. This may be particularly challenging in rural areas. Section 409 of the MMA (Pub. L. 108-173) established the Rural Hospice Demonstration which hopes to test alternative mechanisms for providing hospice services for beneficiaries who lack an appropriate caregiver and who reside in rural areas. In this demonstration, a hospice organization may provide all services in an inpatient facility which serves as a beneficiary's home; however, payment for inpatient care must meet the usual level of care requirements. In this demonstration, inpatient respite care is not possible since there is no caregiver. For specific information on this demonstration, refer to: *http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/itemdetail.aspitemID=CMS1183983* . * Comment:* We received nine items of correspondence regarding the clarification of the general inpatient level of care and its use when there is a breakdown in caregiver support. Several commenters supported the clarification, however the majority did not, as we describe below. Several commenters stated that they shared our concern that the general inpatient level of care not become a source of abuse and the need to focus on hospice providers who use the general inpatient level of care inappropriately. Two commenters stated that they supported steps to eliminate any potential collusion or inducements in this area. * Response:* We appreciate the comments and thank those who were in support of this provision. The intent of this clarification was to ensure that the general inpatient level of care be utilized appropriately and in accordance with statute, regulations and policy. Our focus was not on fraudulent or abusive use of the general inpatient level of care, but rather on ensuring that the general inpatient level of care is properly utilized in accordance with established criteria. * Comment:* Some commenters believed that the clarification was overly prescriptive while others believed that this was not a clarification of existing policy, but was a new interpretation. Some commenters expressed that the intent of the general inpatient level of care, at the inception of the benefit, was to address the need for pain control and symptom management as well as care for patients whose caregiver or home support has broken down, making it no longer feasible to furnish care in the home. One commenter indicated that use of the general inpatient level of care in the event of caregiver breakdown met the requirements in 418.302 as a condition of participation. The same commenter added that the proposed interpretation shifts the focus from caring for patients in the appropriate setting to a billing and reimbursement issue. Some commenters stated that this provision was designed to reduce expenditures without regard to patient safety and hospice expenses. Other commenters also strongly disagreed with the clarification. They indicated that Medicare policy has been interpreted for more than twenty years to mean that general inpatient level of care can be used for caregiver breakdown and the practice of billing at the higher level of care in those circumstances is consistent with written CMS and fiscal intermediary guidance. Some commenters stated that the definition of general inpatient care in the hospice regulations supported the use of general inpatient level of care for caregiver breakdown. One commenter stated that it was inappropriate to punish patients by removing a long established benefit for the hospice program because of the perception that some hospices are using the general inpatient level of care inappropriately. * Response:* We disagree with the commenter who believes that this clarification is a new interpretation. Rather, we seek to clarify here our established policy by providing what we believe is a helpful explanation of how our policies should be interpreted and applied. We are not making any policy changes with this clarification. We believe that this clarification is needed because, as some commenters recognize, the general inpatient level of care has been used for situations where caregiver breakdown has occurred. The level of care needed to manage pain and symptoms is the basis for the general inpatient level of care in the statute, regulations and policy, none of which recognizes caregiver breakdown as an indication for the general inpatient level of care. The Medicare Benefit Policy Manual, Chapter 9—Coverage of Hospice Services, section 40.1.5—Short-Term Inpatient Care, indicates that skilled nursing care may be needed by a patient whose home support has broken down. In the proposed rule we acknowledged this and indicated that if the hospice and the caregiver, working together, are no longer able to provide the necessary skilled nursing care in the individual's home, and if the individual's pain and symptom management can no longer be provided at home, then the individual may be eligible for a short term general inpatient level of care. Section 1861(dd)(1) of the Act defines hospice care as the items and services to be provided to a terminally ill individual by a hospice directly or under arrangement. The statute goes on to specify the items and services, but does not include caregiver services. This means that Medicare does not pay for caregiver services under the hospice benefit. In further support, § 418.98 sets forth the hospice conditions of participation requiring hospices to make available “inpatient care* * * for pain control, symptom management and respite purposes * * *.” Section 418.202 lists the covered hospice services and includes short-term inpatient care at § 418.202(e), stating “inpatient care may be required for procedures necessary for pain control or acute or chronic symptom management. Inpatient care may also be furnished as a means of providing respite for the individual's family or other persons caring for the individual at home.” Further, § 418.302(b)(4) provides that “a general inpatient care day is a day on which an individual who has elected hospice care receives general inpatient care in an inpatient facility for pain control or acute or chronic symptom management which cannot be managed in other settings.” We believe that there is no support for the comments that suggest that the intent of the general inpatient level of care was to include care for patients whose home support has broken down. We also disagree with the comment that this clarification shifts the focus from caring for patients to a purely billing and reimbursement issue and that there needs to be a humane and practical alternative. Our discussions in the proposed rule and in this final rule have focused on the provision of care and the level of care needed by the patient. However, certain billing requirements and payment amounts are associated with each level of care. In cases where a particular level of care is provided because of circumstances that are inappropriate to warrant that particular level of care (here, general inpatient provided because of caregiver breakdown), it is inappropriate for the hospice to bill and receive payment for the general inpatient level of care. * Comment:* Several commenters indicated that the general inpatient level of care was appropriate in rare circumstances where the patient's care network breakdown is not recoverable after a short period of inpatient respite care. Other commenters expressed the need to provide inpatient care immediately for caregiver breakdown. The same commenters believe that the immediate need would prohibit the use of inpatient respite care, which they indicated was a planned admission. One commenter strongly objected to the statement in the proposed rule that specified the requirement for the provision of an intensity of care to support the general inpatient level of care. However, some commenters stated that more frequent use of general inpatient level of care is appropriate as hospices are experiencing difficulty finding adequate caregivers. Some commenters stated that general inpatient level of care provided the only option other than discharging patients from the hospice benefit to long term care facilities. Others stated that the proposed clarification implied that hospice care must be terminated when there is a situation of caregiver breakdown, as there was no Medicare hospice benefit category to care for patients without caregiver support. Some commenters stated that we did not address how caregiver breakdown situations should be addressed while others implied that unless hospices could bill for general inpatient level of care for caregiver breakdown, patients' symptoms could be uncontrolled necessitating the general inpatient level of care. *Response:* We disagree with the comment that we did not indicate how caregiver breakdown situations should be addressed. We indicated in the proposed rule that there is nothing prohibiting a Medicare approved facility from serving as the individual's home. However, Medicare daily per-diem payments are based on medically reasonable and necessary levels of care as described in the Medicare regulations at § 418.302: A routine home care day is a day on which an individual is at home and is not receiving continuous care; a continuous home care day is a day on which an individual is not in an inpatient facility and receives hospice care consisting predominantly of nursing care on a continuous basis at home during brief periods of crisis as described in § 418.204(a), to maintain the terminally ill patient at home; an inpatient respite care day is a day on which the individual receives care in an approved facility on a short-term basis for respite; and a general inpatient care day is a day on which an individual receives general inpatient care in an inpatient facility for pain control or acute or chronic symptom management which cannot be managed in other setting. Medicare payment is made based on the medically reasonable and necessary level of care provided, and not simply where that care is provided. As discussed above, it is not appropriate to bill Medicare for the general inpatient care day for situations where the individual's caregiver support has broken down unless the coverage requirements for the general inpatient level of care are otherwise met. We disagree with the comments that patients will need to be discharged from the hospice benefit to long term care facilities because discharge for caregiver breakdown does not meet the discharge requirements in the regulations at § 418.26. The requirements for discharge at § 418.26 state that a hospice may discharge a patient if the patient moves out of the hospice service area or transfers to another hospice; the hospice determines that the patient is no longer terminally ill; or the hospice discharges the patient for cause. We also disagree with the comment that patients will be forced to revoke the hospice benefit if there is caregiver breakdown. Revocation of the hospice benefit as described in § 418.28 is an action initiated by the individual (patient) and not by the hospice provider. Finally, we disagree with the comment that denying the use of the general inpatient level of care for caregiver breakdown will result in limitation of access. We have discussed various ways of providing care in this situation, such as the use of inpatient respite or use of alternative sources of payment for room and board, that we believe are appropriate alternatives to meeting the needs of the individual. *Comment:* One commenter stated that hospices have seen an erosion of the use of the inpatient benefit and many offer very little inpatient care. This commenter concluded that the clarification represents a reduction in the benefit and will create a new limitation on access to hospice care and patients will seek inpatient hospital admissions instead of receiving hospice services at the general inpatient level of care. Several commenters stated that fiscal intermediaries have allowed the use of general inpatient care for caregiver breakdown. *Response:* We disagree that our clarification on the use of the general inpatient level of care represents a reduction in the Medicare hospice benefit and that it will result in a limitation on access to hospice care. As we noted above, we are not making any policy changes concerning general inpatient care, rather, we are clarifying our established policy. We also disagree that there has been an erosion of the use of general inpatient level of care. Our data, which is available on the hospice Web site at *http://www.cms.hhs.gov/center/hospice.asp* demonstrates that use and payment for the general inpatient level of care has been increasing each year. We also do not agree that better compliance with statute, regulations and policy will limit access to hospice care nor do we see our clarification as an inducement to increase hospital admissions. *Comment:* One commenter questioned why this clarification was being made when we were unable to quantify the extent of the use of general inpatient in the event of caregiver breakdown and suggested that further analysis be done. The same commenter indicated that the cost savings were inaccurate as our assumption of potential savings is based on current reimbursement rates for inpatient respite services. The same commenter believes that the inpatient respite care payment rate is inadequate. Several other commenters indicated that the reimbursement rate for inpatient respite care was inadequate. Several commenters suggested the following: Extending the current 5-day limitation on inpatient respite care; revising policy to allow for the use of the general inpatient level of care when documentation indicates that a sufficient caregiver network cannot be restored in a few days; or establishing an alternative payment mechanism in the hospice benefit for situations where there is caregiver breakdown. One commenter suggested that Medicare work with hospice providers to increase the average length of stay to that which was originally intended in legislation and in regulation. The same commenter stated that studies show that hospice care saves Medicare dollars. Several offered to work with CMS to find an alternative policy to meet patient needs while protecting the Medicare trust fund. *Response:* We appreciate these suggestions and will keep them in mind as we continue to evaluate Medicare hospice payment policy. We noted in the proposed rule that we are unable to quantify the use of the general inpatient level of care for caregiver breakdown. In the proposed rule we provided an example of the potential impact, as we did not have empirical data to suggest the actual usage. This example demonstrated the cost savings to Medicare by using as an example, what we believe could be a cost saving if we assumed that 5 percent of the days and expenditures for general inpatient level of care were attributable to caregiver breakdown. However, the unavailability of exact utilization rates does not preclude us from ensuring that the general inpatient level of care is being billed as we intended. Based upon the comments we received, we believe that the use of the general inpatient level of care for caregiver breakdown may be more pervasive than we had envisioned at the time of the proposed rule. We disagree with the commenter who suggested that the original legislation and regulation intended for the average length of stay to be at a specified level. While the statute defines the terminal diagnosis as having a prognosis of six months or less if the disease runs its normal course, this does not imply that there is, or ever was, a targeted length of stay that is required. The regulations require that an individualized plan of care be developed and updated to identify patient and family needs and the medically reasonable and necessary items and services that are required to meet these needs. In addition, as individuals vary in their responses to illness and care, we expect to see some variability in lengths of stay. We do not believe that it is feasible or prudent to specify or predetermine what lengths of stay should or must be achieved to measure or evaluate the effectiveness of care provided. Regarding the comment that the reimbursement rate for inpatient respite care is inadequate, in the proposed rule, we did not propose to make any adjustments on the payment rates and merely indicated that the hospice payment rates are adjusted annually based upon the full market basket percentage increase. We are aware of studies which suggest that the inpatient respite care payment rate may not reflect the costs for providing this level of care. We will consider the comments made concerning the inpatient respite care rate as we continue to examine Medicare hospice payment policy. G. Certification of the Terminal Illness Section 1814(a)(7)(A)(i) of the Act stipulates that the individual's attending physician and the hospice medical director initially certify the individual's terminal diagnosis with a prognosis of six months or less if the disease runs its normal course. Our regulations at § 418.22 discuss the requirements of the certification, including documentation requirements. As discussed in the proposed rule, we are aware that some providers permit the hospice admission nurse to determine eligibility for hospice services and to certify the individual's terminal diagnosis. In the proposed rule, we explained that the statute is explicit in the requirement that the attending physician and the hospice medical director determine the terminal diagnosis, and his or her signature on the certification attests to that fact. *Comment:* We received three items of correspondence regarding this clarification. One commenter supported the clarification of the responsibility of the hospice medical director and the attending physician to certify the terminal illness. One commenter asked if a hospice medical director visit is required at the time of admission to a hospice and what is the time frame for the visit. Another commenter stated that concurrence of the hospice medical director and the attending physician may be tacit and no communication is required between them. *Response:* As discussed above, section 1814(a)(7)(A)(i) of the Act stipulates that the individual's attending physician and the hospice medical director each initially certify that the individual is terminally ill with a medical life expectancy of six months or less if the disease runs its normal course. Our regulations at § 418.25(a) of hospice regulations indicate, that the hospice admits a patient only on the recommendation of the medical director in consultation with, or with input, from the patient's attending physician (if any). As noted in the proposed rule, the requirements of the physician certification, including supportive documentation, were discussed in the Medicare Program; Hospice Care Amendments proposed rule (67 CFR 70363) and final rule (70 CFR 70548). Current regulations do not address a time frame for a physician or hospice medical director visit. III. Provisions of the Final Regulations In this final rule, we are adopting the following provisions, as set forth in the proposed rule, without change. We are also publishing the FY 2008 urban and rural wage index values for hospices in the addendum as well as the table that reflects the impact of the FY 2008 wage index values. A. Annual Update to the Hospice Wage Index The FY 2008 hospice wage index values have been computed utilizing OMB's geographic location definitions (CBSA). The budget neutrality adjustment factor was computed utilizing data from the FY 2006 claims processed through June 2007. The FY 2008 budget neutrality adjustment factor of 1.066671 was applied to hospital wage data above 0.8. The budget neutrality adjustment factor or the hospice floor was applied to the hospital wage data below 0.8, not to exceed 0.8. The wage index values are reflected in Table A and Table B of the Addendum. Specifically, Table A reflects the FY 2008 wage index values for urban areas under the CBSA designations. Table B reflects the FY 2008 wage index values for rural areas under the CBSA designations. B. Rural Areas Without Hospital Wage Data For FY 2008 and subsequent hospice wage index values, for urban labor markets without an urban hospital from which hospital wage index data could be derived, all of the CBSAs within the State will be used to calculate a statewide urban average wage index to use as a reasonable proxy for these areas. Currently, the only CBSA that is affected by this is CBSA 25980, Hinesville-Fort Stewart, Georgia. For FY 2008 and subsequent hospice wage index values, in cases where there is a rural area without rural hospital wage data, we will use the average pre-floor, pre-reclassified wage index data from all contiguous CBSAs to represent a reasonable proxy for the rural area. This approach meets the criteria that we believe would be the best imputed proxy for rural areas, which
(1)uses pre-floor, pre-reclassified hospital data;
(2)uses the most local data available to impute a rural wage index;
(3)is easy to evaluate; and
(4)is easy to update from year-to-year. Currently there are no hospitals in rural locations in Massachusetts and Puerto Rico. We interpret the term “contiguous” to mean sharing a border. For example, we have determined that the borders of Dukes and Nantucket counties are contiguous with Barnstable and Bristol Counties. Therefore, the pre-floor, pre-reclassified wage index values for the counties of Barnstable (CBSA 12700, Barnstable Town, MA) and Bristol (CBSA 39300, Providence-New Bedford-Fall River, RI-MA) would be averaged resulting in an imputed pre-floor, pre-reclassified rural wage index for rural Massachusetts. Should a similar situation arise in the future, we may re-examine this policy. As discussed in the proposed rule, as there are sufficient economic differences between hospitals in the United States and those in Puerto Rico, we do not believe that this policy would be appropriate for Puerto Rico. We also noted that as we have not yet identified an alternative methodology for imputing a wage index for rural Puerto Rico, we will continue to evaluate the use of other sources. Accordingly, we will continue to use the most recent pre-floor, pre-reclassified wage index previously available for Puerto Rico. C. Nomenclature Changes This final rule and all subsequent hospice rules and notices are considered to incorporate the CBSA changes published in the most recent OMB bulletin that applies to the hospital wage data used to determine the current hospice wage index. The tables in this final rule reflect changes made by these bulletins. The OMB bulletins may be accessed at *http://www.whitehouse.gov/omb/bulletins/index.html.* D. Payment for Hospice Care Based on the Location Where Care Is Furnished Effective January 1, 2008, all payment rates (routine home care, continuous home care, inpatient respite and general inpatient care) will be adjusted by the geographic wage index value of the area where hospice services are provided. In other words, the wage component of each payment rate is multiplied by the wage index value applicable to the location in which the hospice services are provided. Section 418.302 is amended to reflect this change. Hospice providers will be required to indicate on hospice claims, the CBSA for the location where hospice care is provided. E. Educational Requirements for Nurse Practitioners In order to align the hospice qualifications for nurse practitioners under § 418.3 and Part B nurse practitioners under § 410.75, the definition of “attending physician” at § 418.3 is revised to cross reference the training, education and experience requirements described in § 410.75(b). F. Caregiver Breakdown and General Inpatient Care We are not implementing any changes regarding the general inpatient level of care and caregiver breakdown, but are providing clarification of existing policy, statute, and hospice regulations. The Medicare hospice benefit provides for care that is medically reasonable and necessary for the palliation and management of terminal and related conditions, and is structured in such a way to enable the individual with a terminal condition to remain at home, in the company of family and friends. The statute, our regulations at § 418.202(e), and Medicare hospice policy require that in order to receive payment for general inpatient care under the Medicare hospice benefit, beneficiaries must require an intensity of care directed towards pain control and symptom management that cannot be managed in any other setting. It is the level of care provided to meet the individual's needs that determines payment rates for Medicare services. In other words, caregiver breakdown should not be billed as general inpatient care regardless where the services are provided, unless the intensity-of-care requirement is met. If an individual no longer is able to remain at home or if the individual's caregiver is no longer able to provide care, and the required care does not meet the requirements for general inpatient care, the hospice may not bill this care at the general inpatient level of care. This situation is considered to be caregiver breakdown. This does not imply or suggest that the individual must be discharged from the hospice if caregiver breakdown occurs. It does mean that the hospice must find alternative means for the provision of caregiver services, which may include payment for room and board, as Medicare does not pay for caregiver services, nor does it pay for room and board. G. Certification of Terminal Illness We are not making any changes to the certification of terminal illness requirements. We are clarifying that the statute requires that the attending physician and the hospice medical director, not the admission nurse, initially certify the terminal diagnosis with a prognosis of six months or less if the disease runs its normal course. The regulations require that there be documentation in the medical record to support the initial as well as any subsequent certifications. The admission nurse may obtain information supporting the terminal illness in order to allow the attending physician and the medical director to have the necessary information to make the terminal illness determination. But, the determination of the terminal illness cannot be delegated to an admission nurse or any other employee. IV. Collection of Information Requirements This document does not impose any information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). V. Regulatory Impact Analysis A. Overall Impact We have examined the impacts of this final rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act
(RFA)(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. We estimated the impact on hospices, as a result of the changes to the FY 2008 hospice wage index. As discussed previously, the methodology for computing the wage index was determined through a negotiated rulemaking committee and implemented in the August 8, 1997 final rule (62 FR 42860). This final rule updates the hospice wage index in accordance with our regulation and that methodology, incorporating the CBSA designations used in the FY 2007 hospital wage index data. • Table 1 categorizes the impact of the FY 2008 wage index values on hospices by various geographic and provider characteristics. We estimate that the total hospice payments will increase $2,860,000 as a result of the application of the FY 2008 wage index values. As discussed in the proposed rule as well as in this final rule, the impact analysis only reflects the FY 2008 wage index values. The FY 2008 hospice payment rates are promulgated through administrative issuance and are not included in the impact analysis. • Table A reflects the FY 2008 wage index values for urban areas designations. • Table B reflects the FY 2008 wage index values for rural areas designations. Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any one year). We have determined that this final rule is not an economically significant rule under this Executive Order. The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospices and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6.5 million to $31.5 million in any one year (for details, see the Small Business Administration's regulation at 65 FR 69432, that sets forth size standards for health care industries). For purposes of the RFA, most hospices are small entities. As indicated in Table 1 below, there are 2,956 hospices. Approximately 53 percent of Medicare certified hospices are identified as voluntary, government, or other agencies and, therefore, are considered small entities. Because the National Hospice and Palliative Care Organization estimates that approximately 79 percent of hospice patients are Medicare beneficiaries, we have not considered other sources of revenue in this analysis. Furthermore, the wage index methodology was previously determined by consensus, through a negotiated rulemaking committee that included representatives of national hospice associations, rural, urban, large and small hospices, multi-site hospices, and consumer groups. Based on all of the options considered, the committee agreed on the methodology described in the committee statement, and it was adopted into regulation in the August 8, 1997 final rule. In developing the process for updating the wage index in the 1997 final rule, we considered the impact of this methodology on small entities and attempted to mitigate any potential negative effects. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside a CBSA and has fewer than 100 beds. We have determined that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. We are not preparing an analysis for the RFA because we have determined that this rule will not have a significant economic impact on a substantial number of small entities. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditures in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $120 million or more. This final rule is not anticipated to have an effect on State, local, or tribal governments or on the private sector of $120 million or more. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this final rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have an impact on the rights, roles, and responsibilities of State, local, or tribal governments. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. B. Anticipated Effects As discussed in the proposed rule, we are unable to quantify the extent of the usage of the general inpatient level of care in the event of caregiver breakdown. Therefore, we are unable to definitively anticipate the impact of our clarification of the general inpatient level of care policy in the event of caregiver breakdown. For this reason, we solicited comment on what the impact of our clarification might be. We did not receive any substantive comments on the impact. Based on anecdotal evidence as well as substantial increases in the number of claims submitted for general inpatient care, however, we believe a small proportion of patient days attributed to general inpatient care would be appropriately allocated to inpatient respite care with this clarification. Significant savings could be realized even if only a small proportion of patient days attributed to general inpatient care were allocated to inpatient respite care. In the proposed rule we cited an example to determine the impact. In that example, we allocated 5.0 percent of general inpatient care days to inpatient respite care, using the FY 2005 patient days, expenditures and number of beneficiaries electing the hospice benefit to estimate the impact of the clarification of existing policy in this final rule. The number of inpatient days was adjusted from 1,250,678 to 1,188,144. The number of inpatient respite days was adjusted from 96,646 to 159,180. While inpatient respite expenditures increased from $14,000,000 to $23,058,570, general inpatient care expenditures decreased from $737,300,000 to $700,435,000. In total, if 5.0 percent of patient days that were attributed to general inpatient care in FY 2005 were allocated to the inpatient respite level of care, it would have resulted in net savings of $27,806,430. The impact analysis of this final rule represents the projected effects of the changes in the hospice wage index from FY 2007 to FY 2008. We estimate the effects by estimating payments for FY 2008 using the FY 2007 wage index values while holding all other payment variables constant. We note that certain events may combine to limit the scope or accuracy of our impact analysis because such an analysis is future oriented and, thus, susceptible to forecasting errors due to other changes in the forecasted impact time period. The nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon hospices. For the purposes of this final rule, we compared estimated payments using the FY 1983 hospice wage index to estimated payments using the FY 2008 wage index and determined the hospice wage index to be budget neutral. Budget neutrality means that, in a given year, estimated aggregate payments for Medicare hospice services using the FY 2008 wage index would equal estimated aggregate payments that would have been made for the same services if the 1983 wage index had remained in effect. Budget neutrality to 1983 does not imply that estimated payments would not increase since the budget neutrality applies only to the wage index portion and not the total payment rate, which accommodates inflation. As discussed above, we use the latest claims file available to us to develop the impact table when we issue the annual yearly wage index update. For the purposes of this final rule, data were obtained from the National Claims History file using FY 2006 claims processed through June 2007, which was the most recent available data. We deleted bills from hospice providers that have since closed. For the purposes of this final rule, this file is adequate to demonstrate the impact of the FY 2008 wage index values and is not intended to project the anticipated expenditures for FY 2008. This impact analysis compares hospice payments using the FY 2007 hospice wage index to the estimated payments using the FY 2008 wage index. We note that estimated payments for FY 2008 are determined by using the wage index for FY 2008 and payment rates for FY 2007. We also note that the results in the impact analysis table (Table 1) in this final rule differ from the proposed rule, because we have incorporated the most recent data to determine the budget neutrality adjustment factor. As noted in previous sections, payment rates for FY 2008 are published through administrative issuance. Table 1 demonstrates the results of our analysis. In column 1 we indicate the number of hospices included in our analysis. In column 2, we indicate the number of routine home care days that were included in our analysis, although the analysis was performed on all types of hospice care. Column 3 estimates payments using the FY 2007 wage index values and the FY 2007 payment rates. Column 4 estimates payments using FY 2008 wage index values as well as the FY 2007 payment rates. Column 5 compares columns 3 and 4 and shows the percentage change in estimated hospice payments based on the hospice category. Table 1 also categorizes hospices by various geographic and provider characteristics. The first row displays the aggregate result of the impact for all Medicare-certified hospices. The second and third rows of the table categorize hospices according to their geographic location (urban and rural). Our analysis indicated that there are 1,974 hospices located in urban areas and 982 hospices located in rural areas. The next two groupings in the table indicate the number of hospices by census region, also broken down by urban and rural hospices. The sixth grouping shows the impact on hospices based on the size of the hospice's program. We determined that the majority of hospice payments are made at the routine home care rate. Therefore, we based the size of each individual hospice's program on the number of routine home care days provided in FY 2006. The next grouping shows the impact on hospices by type of ownership. The final grouping shows the impact on hospices defined by whether they are provider-based or freestanding. As indicated in Table 1 below, there are 2,956 hospices. Approximately 53 percent of Medicare-certified hospices are identified as voluntary, government, or other agencies and, therefore, are considered small entities. Because the National Hospice and Palliative Care Organization estimates that approximately 79 percent of hospice patients are Medicare beneficiaries, we have not considered other sources of revenue in this analysis. Furthermore, the wage index methodology was previously determined by consensus, through a negotiated rulemaking committee that included representatives of national hospice associations; rural, urban, large, and small hospices; multi-site hospices; and consumer groups. Based on all of the options considered, the committee agreed on the methodology described in the committee statement, and it was adopted into regulation in the August 8, 1997 final rule. In developing the process for updating the wage index in the 1997 final rule, we considered the impact of this methodology on small entities and attempted to mitigate any potential negative effects. As stated previously, the following discussions are limited to demonstrating trends rather than projected dollars. We used the CBSA designations and wage indices as well as the data from FY 2006 claims processed through June 2007 in developing the impact analysis. For FY 2008, the wage index is the variable that differs between the FY 2007 payments and the FY 2008 estimated payments. FY 2007, payment rates are used for both FY 2007 actual payments and the FY 2008 estimated payments. The FY 2008 payment rates will be adjusted to reflect the full FY 2008 hospital market basket, as required by section 1814(i)(1)(C)(ii)(VII) of the Act. As previously noted, we publish these rates through administrative issuances. As discussed in the FY 2006 final rule (70 FR 45129), hospice agencies may use multiple wage indices to compute their payments based on potentially different geographic locations. For the purposes of this final rule, the location of the beneficiary is used for routine and continuous home care or the CBSA for the location of the hospice agency for respite and general inpatient care. As noted above, beginning January 1, 2008, the wage index utilized will be based on the location of the site of service. As the location of the beneficiary's home and the location of the facility may vary, there will still be variability in geographic location. We anticipate that the location of the various sites will correspond with the geographic location of the hospice and thus we will continue to use the location of the hospice for our analyses. For this analysis, we use payments to the hospice in the aggregate based on the location of the hospice. The impact of hospice wage index changes has been analyzed according to the type of hospice, geographic location, type of ownership, hospice base, and size. Our analysis shows that most hospices are in urban areas and provide the vast majority of routine home care days. Most hospices are medium-sized followed by large hospices. Hospices are almost equal in numbers by ownership with 1,578 designated as non-profit and 1,378 as proprietary. The vast majority of hospices are freestanding. 1. Hospice Size Under the Medicare hospice benefit, hospices can provide four different levels of care days. The majority of the days provided by a hospice are routine home care
(RHC)days representing over 70 percent of the services provided by a hospice. Therefore, the number of RHC days can be used as a proxy for the size of the hospice, that is, the more days of care provided, the larger the hospice. As discussed in the August 4, 2005 final rule, we currently use three size designations to present the impact analyses. The three categories are: small agencies having 0 to 3,499 RHC days; medium agencies having 3,500 to 19,999 RHC days; and large agencies having 20,000 or more RHC days. Using RHC days as a proxy for size, our analysis indicates that the proposed FY 2008 wage index values are anticipated to have virtually no impact on hospice providers, with a slight increase of 0.1 percent anticipated for medium hospices while no change is anticipated for small or large hospices. 2. Geographic Location Our analysis demonstrates that the proposed FY 2008 wage index values will result in little change in estimated payments with urban hospices anticipated to experience no change while rural hospices are anticipated to experience a slight increase of 0.3 percent. For urban hospices, the greatest increase of 0.9 percent is anticipated to be experienced by the Mountain regions, followed by an increase for East North Central of 0.7 percent and Pacific regions of 0.6 percent. The remaining urban regions are anticipated to experience a decrease ranging from 0.1 percent in the West North Central and Middle Atlantic regions to 0.6 percent in the East South Central region. The greatest decrease of 2.4 percent is anticipated for Puerto Rico. For rural hospices, Puerto Rico is anticipated to experience no change. Two regions are anticipated to experience a decrease of 1.1 percent for New England and 0.3 percent for the mountain regions. The remaining regions are anticipated to experience an increase ranging from 0.1 percent for the South Atlantic region to 0.6 percent for the Middle Atlantic, East South Central and West North Central regions. 3. Type of Ownership By type of ownership, non-profit hospices are anticipated to experience a slight increase of 0.1 percent in payment while government hospices are anticipated to experience a slight increase of 0.2 percent. No change is anticipated for proprietary hospices. Not specified hospices in the “other” category are anticipated to experience a slight decrease of 0.2 percent. 4. Hospice Base No change in payment is anticipated for freestanding facilities. Home health, hospital, and skilled nursing facilities are anticipated to experience an increase of 0.1, 0.3, and 0.7 percent, respectively. Table 1.—Impact of Hospice Wage Index Change Number of Hospices Number of Routine Home Care Days in Thousands Payments using FY 2007 Wage Index in Thousands Estimated Payments using FY 2008 CBSA Wage Index in Thousands Percent Change in Hospice Payments
(5)ALL HOSPICES: 2956 61,125 9,148,694 9,151,554 0.0 URBAN HOSPICES 1974 52,426 8,048,410 8,048,224 0.0 RURAL HOSPICES 982 8,699 1,100,284 1,103,330 0.3 BY REGION—URBAN: NEW ENGLAND 112 1,772 313,059 311,816 −0.4 MIDDLE ATLANTIC 198 5,211 843,068 842,000 −0.1 SOUTH ATLANTIC 285 11,385 1,839,567 1,831,476 −0.4 EAST NORTH CENTRAL 294 7,568 1,158,628 1,166,376 0.7 EAST SOUTH CENTRAL 157 4,333 586,642 583,333 −0.6 WEST NORTH CENTRAL 151 3,413 471,129 470,666 −0.1 WEST SOUTH CENTRAL 336 7,113 1,007,361 1,002,636 −0.5 MOUNTAIN 182 4,531 702,881 709,230 0.9 PACIFIC 225 6,302 1,054,910 1,061,223 0.6 PUERTO RICO 34 797 71,165 69,468 −2.4 BY REGION—RURAL: NEW ENGLAND 26 144 21,134 20,910 −1.1 MIDDLE ATLANTIC 43 408 52,441 52,765 0.6 SOUTH ATLANTIC 124 1,840 238,972 239,136 0.1 EAST NORTH CENTRAL 140 1,125 146,434 146,747 0.2 EAST SOUTH CENTRAL 142 1,982 240,058 241,528 0.6 WEST NORTH CENTRAL 188 944 120,343 121,061 0.6 WEST SOUTH CENTRAL 163 1,307 153,527 153,934 0.3 MOUNTAIN 103 576 74,972 74,718 −0.3 PACIFIC 52 365 51,809 51,936 0.2 PUERTO RICO 1 7 595 595 0.0 ROUTINE HOME CARE DAYS: 0-3499 DAYS (small) 617 1,060 142,491 142,458 0.0 3500-19,999 DAYS (medium) 1429 14,208 1,994,694 1,996,162 0.1 20,000+ DAYS (large) 910 45,856 7,011,509 7,012,935 0.0 TYPE OF OWNERSHIP: VOLUNTARY 1220 27,555 4,270,787 4,274,723 0.1 PROPRIETARY 1378 30,166 4,380,444 4,379,751 0.0 GOVERNMENT 193 986 133,503 133,745 0.2 OTHER 165 2,417 363,960 363,335 −0.2 HOSPICE BASE: FREESTANDING 1767 45,209 6,752,227 6,750,239 0.0 HOME HEALTH AGENCY 620 9,105 1,369,110 1,370,605 0.1 HOSPITAL 555 6,606 994,451 997,560 0.3 SKILLED NURSING FACILITY 14 205 32,906 33,149 0.7 Note: FY 2007 payment rates were used for estimated payments for FY 2008. FY 2008 payment rates will be adjusted to reflect the full hospital market basket and will be promulgated through administrative issuance. C. Conclusion Our impact analysis compared the FY 2007 wage index to the estimated payments using the FY 2008 wage index. Through the analysis, we estimate that total hospice payments, based on the FY 2008 wage index values, will effectively be budget neutral with an estimated increase from FY 2007 of $2,860,000. As discussed, the budget neutrality adjustment factor is determined by using the pre-floor, pre-reclassified hospital wage data. The impact analysis compares the wage index values, which have had either the budget neutrality adjustment factor or the hospice floor applied. Additionally, we compared estimated payments using the FY 1983 hospice wage index to estimated payments using the FY 2008 wage index and determined the current hospice wage index to be budget neutral, as required by the negotiated rulemaking committee. As noted above, the payment rates used reflect the FY 2007 rates. The FY 2008 payment rates will be adjusted to reflect the full FY 2008 hospital market basket, as required by section 1814(i)(1)(C)(ii)(VII) of the Act. We publish these rates through administrative issuances. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects for 42 CFR Part 418 Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV as set forth below: PART 418—HOSPICE CARE 1. The authority citation for part 418 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart A—General Provision and Definitions 2. Section 418.3 is amended by revising paragraph (1)(ii) in the definition of “attending physician” to read as follows: § 418.3 Definitions.
(1)* * *
(ii)Nurse practitioner who meets the training, education, and experience requirements as described in § 410.75
(b)of this chapter. Subpart G—Payment for Hospice Care 3. Section 418.302 is amended by revising paragraph
(g)to read as follows: § 418.302 Payment procedures for hospice care.
(g)Payment for routine home care, continuous home care, general inpatient care and inpatient respite care is made on the basis of the geographic location where the services are provided. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: July 19, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: August 17, 2007. Michael O. Leavitt, Secretary. BILLING CODE 4120-01-P ER31AU07.000 ER31AU07.001 ER31AU07.002 ER31AU07.003 ER31AU07.004 ER31AU07.005 ER31AU07.006 ER31AU07.007 ER31AU07.008 ER31AU07.009 ER31AU07.010 ER31AU07.011 ER31AU07.012 ER31AU07.013 ER31AU07.014 ER31AU07.015 ER31AU07.016 ER31AU07.017 ER31AU07.018 ER31AU07.019 ER31AU07.020 [FR Doc. 07-4292 Filed 8-30-07; 8:45 am]
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