Unknown. Final rule

12,631 words·~57 min read·/register/2007/06/04/07-2740

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-2007-06-04.xml --- 72 106 Monday, June 4, 2007 Contents Agency Agency for Healthcare Research and Quality NOTICES Consumers’ home health care experiences; request for instruments or items that measure perceptions of home health care quality, 30800-30803 07-2732 Reports and guidance documents; availability, etc.: National health data stewardship, 30803-30805 07-2733 Agricultural Agricultural Marketing Service PROPOSED RULES Honey packers and importers research, promotion, consumer education, and industry information order:

Establishment; old honey research, promotion, and consumer information order terminated, 30924-30940 07-2737 Referendum procedures, 30940-30944 07-2736 Agriculture Agriculture Department See Agricultural Marketing Service See Food Safety and Inspection Service Antitrust Antitrust Division NOTICES Competitive impact statements and proposed consent judgments: Arizona Hospital and Healthcare Association, et al., 30832-30845 07-2686 Army Army Department NOTICES Environmental statements; record of decision:

Fort Lee and Fort A.P. Hill; base closure and realignment actions, 30789-30790 07-2729 Centers Centers for Medicare & Medicaid Services RULES Medicare: Medicare participating inpatient hospitals to Indians; limitation on charges for services, 30706-30711 07-2740 Children Children and Families Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 30805-30806 07-2724 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See Patent and Trademark Office Commission of Fine Commission of Fine Arts NOTICES Meetings, 30779 07-2738 Consumer Consumer Product Safety Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-10619 30779-30781 E7-10620 E7-10625 Defense Defense Department See Army Department See Navy Department NOTICES Arms sales notification; transmittal letter, etc., 30781-30784 07-2743 Privacy Act; systems of records, 30784-30789 E7-10686 E7-10687 E7-10688 E7-10689 Drug Drug Enforcement Administration NOTICES Registration revocations, restrictions, denials, reinstatements:

CRJ Pharmacy, Inc. and YPM Total Care Pharmacy, Inc., 30846-30849 E7-10624 Oviedo Discount Pharmacy, 30849-30855 E7-10627 Taylor, Dale L., M.D., 30855-30858 E7-10622 *Applications, hearings, determinations, etc.:* Johnson Matthey Inc., 30845-30846 E7-10692 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 30792 07-2769 Employment Employment and Training Administration NOTICES Workforce Investment Act; implementation:

Lower living standard income level determination, 30858-30862 E7-10662 Energy Energy Department See Western Area Power Administration EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States: South Carolina, 30704-30706 E7-10696 NOTICES Agency information collection activities; proposals, submissions, and approvals, 30794-30795 E7-10679 Meetings: Local Government Advisory Committee, 30795-30796 E7-10682 Reports and guidance documents; availability, etc.:

Pesticides— Stockholm Convention on Persistent Organic Pollutants; chemical additions; risk management evaluations and profiles, 30796-30799 E7-10699 Executive Executive Office of the President See National Drug Control Policy Office See Presidential Documents FAA Federal Aviation Administration RULES Air carrier certification and operations: Extinguishing agent container requirements; withdrawn, 30946-30947 07-2784 Airworthiness directives: Diamond Aircraft Industries GmbH, 30701-30703 E7-10589 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings;

Sunshine Act; correction, 30862 07-2785 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 30799-30800 E7-10677 Federal Transit Federal Transit Administration NOTICES Reports and guidance documents; availability, etc.: New Starts/Small Starts Policies and Procedures, 30907-30914 07-2774 Fine Arts Fine Arts Commission See Commission of Fine Arts Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc.:

Mingo, Pilot Knob, and Ozark Cavefish National Wildlife Refuges, MO, 30818-30819 E7-10676 Endangered and threatened species: Gray wolf; Western Great Lakes distinct population segment; post-delisting monitoring plan, 30819-30820 E7-10673 Recovery plans— Chiricahua leopard frog, 30820-30821 E7-10674 Food Food Safety and Inspection Service NOTICES Codex Alimentarius Commission: International sanitary and phytosanitary standard-setting activities, 30743-30753 E7-10327 Geological Geological Survey NOTICES Agency information collection activities; proposals, submissions, and approvals, 30821-30822 07-2735 Health Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Medicare & Medicaid Services See Children and Families Administration See Indian Health Service See National Institutes of Health See Substance Abuse and Mental Health Services Administration Indian Indian Health Service RULES Medicare:

Medicare participating inpatient hospitals to Indians; limitation on charges for services, 30706-30711 07-2740 Interior Interior Department See Fish and Wildlife Service See Geological Survey See National Park Service See Reclamation Bureau See Surface Mining Reclamation and Enforcement Office NOTICES Privacy Act; systems of records, 30816-30818 E7-10726 IRS Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 30914-30922 E7-10643 E7-10644 E7-10645 E7-10658 Meetings:

Electronic Tax Administration Advisory Committee, 30922 E7-10650 International International Trade Administration NOTICES Antidumping: Coated free sheet paper from— China, 30758-30766 E7-10705 Indonesia, 30753-30758 E7-10704 Korea, 30766-30771 E7-10706 Stainless steel bar from— Various countries, 30772-30773 E7-10702 Steel concrete reinforcing bars from— Latvia, 30773-30775 E7-10703 Export trade certificates of review, 30775 E7-10638 E7-10639 International International Trade Commission NOTICES Import investigations:

Steel nails from— China and United Arab Emirates, 30831-30832 E7-10684 Welded large diameter line pipe from— Japan and Mexico, 30832 E7-10685 Justice Justice Department See Antitrust Division See Drug Enforcement Administration Labor Labor Department See Employment and Training Administration See Occupational Safety and Health Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 30858 E7-10649 Mine Mine Safety and Health Federal Review Commission See Federal Mine Safety and Health Review Commission National Drug National Drug Control Policy Office NOTICES High intensity drug trafficking areas; designation petitions, 30862-30864 E7-10640 National Highway National Highway Traffic Safety Administration PROPOSED RULES Motor vehicle safety standards:

School bus passenger protection; seat belts on large school buses; meeting, 30739-30742 E7-10568 National Institute National Institute of Standards and Technology RULES Fastener Quality Act; implementation: Insignia applications and other documents; submission mailing address change, 30703-30704 E7-10707 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 30806-30808 E7-10711 E7-10712 Meetings: National Cancer Institute, 30808-30810 07-2752 07-2753 07-2756 07-2766 National Institute of Allergy and Infectious Diseases, 30811-30812 07-2760 National Institute of Arthritis and Musculoskeletal and Skin Diseases, 30812 07-2765 National Institute of Child Health and Human Development, 30810 07-2754 07-2755 07-2757 National Institute of Dental and Craniofacial Research, 30811 07-2759 National Institute of Diabetes and Digestive and Kidney Diseases, 30810-30812 07-2758 07-2764 National Institute on Deafness and Other Communication Disorders, 30812-30813 07-2767 Scientific Review Center, 30813-30814 07-2761 07-2762 07-2763 National National Intelligence, Office of the Director PROPOSED RULES Freedom of Information Act; implementation, 30734-30739 E7-10420 NOAA National Oceanic and Atmospheric Administration RULES International fisheries regulations:

Pacific tuna— Eastern tropical Pacific Ocean; purse seine and longline fisheries restrictions, 30711-30714 E7-10718 International fishery regulations: West Coast States and Western Pacific fisheries— Halibut; Pacific sport charter vessel fishery, 30714-30728 E7-10736 NOTICES Marine mammal permit applications, determinations, etc., 30775-30777 E7-10721 E7-10725 Meetings: Climate Change Science Program Product Development Committee for Synthesis and Assessment Product 1.3, 30777 E7-10663 National Park National Park Service NOTICES Meetings:

Chesapeake and Ohio Canal National Historical Park Advisory Commission, 30822 07-2751 Native American human remains, funerary objects; inventory, repatriation, etc.: American Museum of Natural History, New York, NY, 30823 E7-10713 Anthropological Studies Center, Archaeological Collections Facility, Sonoma State University, Rohnert Park, CA, 30823-30825 07-2770 California Transportation Department, Oakland, CA, et al., 30825-30826 E7-10714 Colorado Archaeological Society, Denver, CO, 30826 E7-10717 Denver Museum of Nature & Science, CO, 30826-30827 E7-10719 Department of History, and Anthropology, and Philosophy, Archaeology Laboratory, Augusta State University, Augusta, GA, 30827-30828 E7-10715 Slater Museum of Natural History, University of Puget Sound, Tacoma, WA, 30828-30829 E7-10729 E7-10731 University of Colorado Museum, Boulder, CO, 30829-30830 E7-10716 Navy Navy Department NOTICES Privacy Act; systems of records, 30790-30792 E7-10683 Nuclear Nuclear Regulatory Commission NOTICES Reports and guidance documents; availability, etc.:

Licensees authorized to manufacture or transfer items containing radioactive material for sale or distribution; order of additional security measures, 30864-30870 E7-10691 Licensees authorized to possess and transfer items containing radioactive material quantities of concern; order of additional security measures, 30870-30877 E7-10698 Panoramic and underwater irradiators authorized to possess greater than 370 terabecquerels (10,000 curies) in form of sealed sources, 30877-30882 E7-10695 Occupational Occupational Safety and Health Administration PROPOSED RULES Occupational safety and health standards:

Mechanical power presses, 30729-30734 E7-10655 National Office of National Drug Control Policy See National Drug Control Policy Office National Office of the Director of National Intelligence See National Intelligence, Office of the Director Patent Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 30777-30779 E7-10672 Peace Peace Corps NOTICES Agency information collection activities; proposals, submissions, and approvals, 07-2745 30882-30885 07-2746 07-2747 07-2748 07-2749 07-2750 Presidential Presidential Documents PROCLAMATIONS *Special observances:* Black Music Month (Proc. 8151), 30953-30954 07-2800 National Oceans Month (Proc. 8150), 30949-30952 07-2799 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 30885 E7-10708 Reclamation Reclamation Bureau NOTICES Meetings:

California Bay-Delta Public Advisory Committee, 30830 07-2742 SEC Securities and Exchange Commission NOTICES Investment Company Act of 1940: HealthShares, Inc., et al., 30885-30889 E7-10700 Meetings; Sunshine Act, 30889-30890 E7-10659 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 30891-30893 E7-10680 International Securities Exchange, LLC, 30893-30895 E7-10666 E7-10667 National Association of Securities Dealers, Inc., 30895-30898 E7-10681 New York Stock Exchange LLC, 30898-30901 E7-10661 E7-10668 Philadelphia Stock Exchange, Inc., 30890-30906 E7-10664 E7-10665 SBA Small Business Administration NOTICES Disaster loan areas:

Iowa, 30906 E7-10710 Kansas, 30906-30907 E7-10709 State State Department NOTICES Culturally significant objects imported for exhibition: Paul Gaugin's The Purau Tree and Paul Cezanne's A Modern Olympia, 30907 E7-10701 Substance Substance Abuse and Mental Health Services Administration NOTICES National Registry of Evidence-Based Programs and Practices; expansion and use; review priorities and submission process guidance, 30814-30816 07-2739 Surface Surface Mining Reclamation and Enforcement Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 30830-30831 07-2741 Transportation Transportation Department See Federal Aviation Administration See Federal Transit Administration See National Highway Traffic Safety Administration Treasury Treasury Department See Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 30914 E7-10690 Western Western Area Power Administration NOTICES Environmental statements; notice of intent:

Eastern Plains Transmission Project, CO and KS; meeting, 30792-30794 E7-10697 Separate Parts In This Issue Part II Agriculture Department, Agricultural Marketing Service, 07-2736 30924-30944 07-2737 Part III Transportation Department, Federal Aviation Administration, 30946-30947 07-2784 Part IV Executive Office of the President, Presidential Documents, 30953-30954 07-2800 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. 72 106 Monday, June 4, 2007 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27348; Directorate Identifier 2007-CE-015-AD; Amendment 39-15078; AD 2007-11-21] RIN 2120-AA64 Airworthiness Directives;

Diamond Aircraft Industries GmbH Model DA 40 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: We are adopting a new airworthiness directive

(AD)for the products listed above. This AD results from mandatory continuing airworthiness information

(MCAI)issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: Abnormal manufacturing variations of the universal joints in combination with mechanical wear can lead to a joint failure and subsequent disconnection between selector and the fuel valve. This result in a loss of capability to select the fuel tank for supply. This condition might remain unrecognised by the pilot and can result in fuel starvation during flight and/or unavailability of emergency fuel shutoff. We are issuing this AD to require actions to correct the unsafe condition on these products. DATES: This AD becomes effective July 9, 2007. On July 9, 2007 the Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. FOR FURTHER INFORMATION CONTACT: Mr. Sarjapur Nagarajan, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:

(816)329-4145; fax:

(816)329-4090. SUPPLEMENTARY INFORMATION: Streamlined Issuance of AD The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. The streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and **Federal Register** requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products. This AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The AD contains text copied from the MCAI and for this reason might not follow our plain language principles. Discussion We issued a notice of proposed rulemaking

(NPRM)to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the **Federal Register** on April 2, 2007 (72 FR 15633). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states: Abnormal manufacturing variations of the universal joints in combination with mechanical wear can lead to a joint failure and subsequent disconnection between selector and the fuel valve. This result in a loss of capability to select the fuel tank for supply. This condition might remain unrecognised by the pilot and can result in fuel starvation during flight and/or unavailability of emergency fuel shutoff. Revision History This inspection was initially addressed by Austrian AD A-2004-003. The design of the fuel selector/fuel valve universal joint has than been changed by design change MÄM 40-142/a and was introduced into serial production. The initial repetitive AD inspection interval of 50 Hrs is also applicable for this design. The investigation of the inspections carried out, has identified that the new joint design eliminated the design problem and no additional inspection is required. You may obtain further information by examining the MCAI in the AD docket. Comments We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public. Conclusion We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD. Costs of Compliance We estimate that this AD will affect 476 products of U.S. registry. We also estimate that it will take about 1.5 work-hours per product to comply with basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $57,120, or $120 per product. In addition, we estimate that any necessary follow-on actions will take about 2.5 work-hours and require parts costing $382, for a cost of $582 per product. We have no way of determining the number of products that may need these actions. 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 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 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 regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket. Examining the AD Docket You may examine the AD docket on the Internet at *http://dms.dot.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone

(800)647-5227) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA 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 adding the following new AD: **2007-11-21 Diamond Aircraft Industries GmbH:** Amendment 39-15078; Docket No. FAA-2007-27348; Directorate Identifier 2007-CE-015-AD. Effective Date

(a)This airworthiness directive

(AD)becomes effective July 9, 2007. Affected ADs

(b)None. Applicability

(c)This AD applies to Model DA 40 airplanes, serial numbers 40.006 up to and including 40.079, 40.081 up to and including 40.083, 40.201 up to and including 40.417, that:

(1)Are certificated in any category; and

(2)have fuel shaft part number D41-2823-20-00 Rev “-” installed. Subject

(d)Air Transport Association of America

(ATA)Code 28: Fuel. Reason

(e)The mandatory continuing airworthiness information

(MCAI)states: Abnormal manufacturing variations of the universal joints in combination with mechanical wear can lead to a joint failure and subsequent disconnection between selector and the fuel valve. This results in a loss of capability to select the fuel tank for supply. This condition might remain unrecognised by the pilot and can result in fuel starvation during flight and/or unavailability of emergency fuel shutoff. Revision History This inspection was initially addressed by Austrian AD A-2004-003. The design of the fuel selector/fuel valve universal joint has than been changed by design change MÄM 40-142/a and was introduced into serial production. The initial repetitive AD inspection interval of 50 Hrs is also applicable for this design. The investigation of the inspections carried out, has identified that the new joint design eliminated the design problem and no additional inspection is required. Actions and Compliance

(f)Unless already done, do the following actions:

(1)When the airplane reaches a total of 200 hours time-in-service

(TIS)or within the next 15 hours TIS after July 9, 2007 (the effective date of this AD), whichever occurs later, inspect the universal joint in accordance with Diamond Aircraft Industries GmbH Mandatory Service Bulletin No. MSB 40-030/3, dated January 31, 2006. Repetitively inspect thereafter at intervals not to exceed 50 hours TIS until the modified universal joint assembly specified in paragraph (f)(2) of this AD is installed.

(2)Before further flight, replace the complete joint assembly with the new joint assembly, part number (P/N) D41-2823-20-00 rev “a” or higher in accordance with Diamond Aircraft Industries GmbH Mandatory Service Bulletin No. MSB 40-030/3, dated January 31, 2006, if one or more defects are found on the universal joint during any inspection required by this AD.

(3)The 50-hour TIS repetitive inspection requirement in paragraph (f)(1) of this AD is terminated when the universal joint has been replaced with the new universal joint assembly, P/N D41-2823-20-00 rev “a” or higher, as specified in paragraph (f)(2) of this AD.

(4)At 1,000-hour TIS intervals after the replacement specified in paragraph (f)(2) of this AD, inspect the universal joints in the fuel selector shaft as specified in Diamond Aircraft DA 40 Series Temporary Revision to the Airplane Maintenance Manual (AMM), AMM-TR-MÄM-40-142/a, Fuel Tank Selector, Doc. No. 6.02.01, Section 25-20-00, page 28a, dated May 23, 2005. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: The MCAI incorporates the repetitive inspection requirement for the new joint assembly, P/N D41-2823-20-00 rev “a” or higher, into the AMM. In order for this inspection to be required for U.S.-owner/operators, we are incorporating the 1,000-hour repetitive inspection into this AD. Other FAA AD Provisions

(g)The following provisions also apply to this AD:

(1)Alternative Methods of Compliance (AMOCs): The Manager, Standards Staff, FAA, Small Airplane Directorate, ATTN: Sarjapur Nagarajan, Aerospace Engineer, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:

(816)329-4145; fax:

(816)329-4090, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector

(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

(2)Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

(3)Reporting Requirements: For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ), the Office of Management and Budget

(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information

(h)Refer to MCAI European Aviation Safety Agency

(EASA)AD No. 2006-0067, dated March 24, 2006; and Diamond Aircraft Industries GmbH Mandatory Service Bulletin No. MSB 40-030/3, dated January 31, 2006, for related information. Material Incorporated by Reference

(i)You must use Diamond Aircraft Industries GmbH Mandatory Service Bulletin No. MSB 40-030/3, dated January 31, 2006, to do the actions required by this AD, unless the AD specifies otherwise.

(1)The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.

(2)For service information identified in this AD, contact Diamond Aircraft Industries GmbH, N.A. Otto-Straße 5, A-2700 Wiener Neustadt; telephone: +43 2622 26700; fax: +43 2622 26780; e-mail: *office@diamond-air.at.*

(3)You may review copies at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Room 506, Kansas City, Missouri 64106; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Kansas City, Missouri, on May 25, 2007. Kim Smith, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-10589 Filed 6-1-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF COMMERCE National Institute of Standards and Technology 15 CFR Part 280 [Docket No. 070404076-7077-01] RIN 0693-AB57 Fastener Quality Act AGENCY: National Institute of Standards and Technology, United States Department of Commerce. ACTION: Final Rule. SUMMARY: The Director of the National Institute of Standards and Technology (NIST), United States Department of Commerce, and the Director of the United States Patent and Trademark Office (USPTO), United States Department of Commerce, are amending the rules that implement the Fastener Quality Act of 1999 to provide that all documents submitted in connection with the recordal of fastener insignia must be mailed to a particular postal box maintained by United States Patent and Trademark Office. DATES: This final rule is effective on June 4, 2007. FOR FURTHER INFORMATION CONTACT: Jennifer Chicoski, Office of the Commissioner for Trademarks, P.O. Box 1451, Alexandria, Virginia 22313-1451, telephone number

(571)272-8943, e-mail address *jennifer.chicoski@uspto.gov.* SUPPLEMENTARY INFORMATION: Background The Fastener Quality Act of 1999, Public Law 101-592 (as amended by Pub. L. 104-113, Pub. L. 105-234 and Pub. L. 106-34) requires the Secretary of Commerce to establish a program for the recordation of the identifying insignia of certain fasteners. The rules set forth at Subpart D of 15 CFR 280.300 *et seq.* accordingly provide for a recordation system, and that system is maintained at the United States Patent and Trademark Office (USPTO). One of the rules, 15 CFR 280.310(d), provides that all documents pertaining to recordation must be mailed to a particular postal box maintained by the USPTO in Arlington, VA. A second rule, Section 280.323(a), requires copies of documentation of transfers or assignments of trademark applications or registrations which form the basis of a recorded insignia be sent to a postal box in Washington, DC. The efficiency of the insignia recordation program will be enhanced if documents submitted in connection with the program are mailed to a postal box that is at the USPTO's headquarters in Alexandria, Virginia. Accordingly, Sections 280.300 *et seq.* are amended to provide that these documents be mailed to that postal box. This final rule amends section 280.310, Application for Insignia, and section 280.323, Transfer or Assignment of the Trademark Registration or Recorded Insignia, to identify the postal box to which all documents pertaining to recordation should be sent. The United States Postal Service has provided a separate routing +4 zip code to distinguish mail relating to the Fastener Quality Act

(FQA)from other USPTO mail, and all such correspondence should now be sent to the USPTO's main headquarters, addressed with the separate routing +4 zip code. The USPTO appreciates that it will take some period of time for all persons filing correspondence relating to the FQA to become accustomed to the address change. Although the address change is effective immediately, the USPTO plans to arrange for continued delivery of correspondence addressed to the former Arlington, Virginia 22215 address as a courtesy for a limited period of time. The USPTO cannot ensure the availability of the Arlington, Virginia Post Office Box for receipt of FQA correspondence after October 31, 2007. Additional Information Executive Order 12866 This rule of agency organization and management is not subject to Executive Order 12866. Executive Order 12612 This rule does not contain policies with Federalism implications sufficient to warrant preparation of a Federalism assessment under Executive Order 12612. Administrative Procedure Act Prior notice and an opportunity for public comment are not required for this rule of agency organization, procedure, or practice. 5 U.S.C. 553(b)(A). This rule revises the regulations to identify the address where documents submitted in connection with the recordal of fastener insignia may be mailed. Regulatory Flexibility Act Because notice and comment are not required under 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) are inapplicable. As such, a regulatory flexibility analysis is not required. Paperwork Reduction Act This rule involves a collection of information that is subject to the Paperwork Reduction Act (PRA), and that has been approved by the Office of Management and Budget

(OMB)under control number 0651-0028. Notwithstanding any other provision of the law, no person is required to comply, nor shall any person be subject to penalty for failure to comply, with a collection of information, subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number. National Environmental Policy Act This rule will not significantly affect the quality of the human environment. Therefore, an environmental assessment or Environmental Impact Statement is not required to be prepared under the National Environmental Policy Act of 1969. List of Subjects in 15 CFR Part 280 Business and industry, Imports, Laboratories, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the National Institute of Standards and Technology and the United States Patent and Trademark Office amend 15 CFR part 280, subpart D, as follows: PART 280—FASTENER QUALITY 1. The authority citation for part 280 continues to read: Authority: 15 U.S.C. 5401 *et seq.* Subpart D—Recordal of Insignia 2. Section 280.310 is amended by revising paragraph

(d)to read as follows: § 280.310 Application for insignia.

(d)Applications and other documents should be addressed to: Director, United States Patent and Trademark Office, ATTN: FQA, 600 Dulany Street, MDE-10A71, Alexandria, VA 22314-5793. 3. Section 280.323 is amended by revising paragraph

(a)to read as follows: § 280.323 Transfer or assignment of the trademark registration or recorded insignia.

(a)A trademark application or registration which forms the basis of a fastener recordal may be transferred or assigned. Any transfer or assignment of such an application or registration must be recorded in the United States Patent and Trademark Office within three months of the transfer or assignment. A copy of such transfer or assignment must also be sent to: Director, United States Patent and Trademark Office, ATTN: FQA, 600 Dulany Street, MDE-10A71, Alexandria, VA 22314-5793. Dated: May 24, 2007. Jon W. Dudas, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. Dated: May 29, 2007. James M. Turner, Deputy Director, National Institute of Standards and Technology. [FR Doc. E7-10707 Filed 6-1-07; 8:45 am] BILLING CODE 3510-16-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2005-SC-0003, EPA-R04-OAR-2005-SC-0005-200620c; FRL-8321-4] Approval and Promulgation of Implementation Plans; South Carolina: Revisions to State Implementation Plan; Clarification AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; clarification. SUMMARY: EPA is clarifying its approval of revisions to the South Carolina State Implementation Plan (SIP), published in the **Federal Register** on December 7, 2006. EPA's action modified South Carolina's federally approved Regulation 61-62.1 “Definitions and General Requirements,” by revising the definition of Volatile Organic Compounds (VOC). This action merely clarifies the list of compounds which are excluded from the definition of VOC. DATES: This action is effective June 4, 2007. ADDRESSES: EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2005-SC-0005. All documents in the docket are listed on the *http://www.regulations.gov* Web site. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *www.regulations.gov* or in hard copy at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal holidays. FOR FURTHER INFORMATION CONTACT: Stacy Harder, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number is

(404)562-9042. Ms. Harder can also be reached via electronic mail at *harder.stacy@epa.gov.* SUPPLEMENTARY INFORMATION: I. What Is the Background for This Action? Through a direct final rulemaking, published in the **Federal Register** on December 7, 2006, (71 FR 70880), EPA approved revisions to the South Carolina SIP. These revisions were submitted on October 24, 2005, by the South Carolina Department of Health and Environmental Control (SC DHEC). The purpose of EPA's action was to revise the definition of VOC. Specifically, that SIP revision updated the nomenclature for compounds excluded from the definition of VOC in SC Regulation 61-62.1, to be consistent with the Federal rule published on November 29, 2004, (69 FR 69298). It also added four compounds to the list of those excluded from the definition of VOC, on the basis that they make a negligible contribution to ozone formation, also consistent with the Federal rule. Additionally, the revision added the compound *t* -butyl acetate (TBAC or TBAc) to the list of compounds excluded from the definition of VOC for purposes of emissions limitations or VOC content requirements. EPA is clarifying the action taken on December 7, 2006, due to feedback that the rulemaking was not clear in its intent. II. EPA's Action The purpose of this action is only to clarify a previous action and no substantial changes are being made. Below is the list of the compounds presented in the December 7, 2006, rulemaking, which updates the nomenclature for the following compounds excluded from the definition of VOC in the South Carolina SIP: • (CF 3 ) 2 CFCF 2 OC 2 H 5 to (2-(ethoxydifluoromethyl)-(1,1,1,2,3,3,3-heptafluoropropane) • CFC-113 (1,1,2-trichloro-1,2,2-trifluoroethane) • CFC-114 (1,2-dichloro-1,1,2,2-tetrafluoroethane) • HCFC-123 (1,1,1-trifluoro-2,2-dichloroethane) • HCFC-134a (1,1,1,2-tetrafluoroethane) • HCFC-141b (1,1-dichloro-1-fluoroethane) • HCFC-142b (1-chloro-1,1-difluoroethane) • HFE-7100 (1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxybutane) or (C 4 F 9 OCH 3 ) • HFE-7200 (1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane) or (C 4 F 9 OC 2 H 5 ) • Methylene chloride (dichloromethane) • Perchloroethylene (tetrachloroethylene); and perfluorocarbon compounds that fall into these classes:

(i)Cyclic, branched, or linear, completely fluorinated alkanes;

(ii)cyclic, branched, or linear, completely fluorinated alkanes;

(iii)cyclic, branched, or linear, completely fluorinated ethers with no unsaturations;

(iv)sulfur containing perfluorocarbons with no unsaturations and with sulfur bonds only to carbon and fluorine. Additionally, the 2006 action added the following five compounds to the list of those excluded from the definition of VOC: • HFE-7000 (1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane) or (n-C 3 F 7 OCH 3 ) • HFE-7500 (3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl) hexane • HFC-227ea (1,1,1,2,3,3,3-heptafluoropropane) • Methyl formate (HCOOCH 3 ) • The following compound(s) are defined as VOC only for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling and inventory requirements that apply to VOC and shall be uniquely identified in emission reports; they are not, however, defined as VOC for purposes of VOC emissions limitations or VOC content requirements: T-butyl acetate (TBAC or TBAc). EPA has determined that today's action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act

(APA)which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are impracticable, unnecessary, or contrary to the public interest. Public notice and comment for this action are unnecessary because today's action to provide clarification of those compounds exempted from the definition of VOC, has no substantive impact on EPA's December 7, 2006, approval. The clarification for the list of compounds exempted from the definition of VOC, in EPA's direct final rule published on December 7, 2006, makes no substantive difference to EPA's analysis as set out in that rule. In addition, EPA can identify no particular reason why the public would be interested in being notified of this clarification or in having the opportunity to comment on the clarification prior to this action being finalized, since this clarification action does not change EPA's analysis for the update to the nomenclature for those compounds excluded from the definition of VOC, and the addition of five compounds to the list of those excluded from the definition of VOC. EPA also finds that there is good cause under APA section 553(d)(3) for this clarification to become effective on the date of publication of this action. Section 553(d)(3) of the APA allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in APA section 553(d)(3), is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule simply clarifies EPA's December 7, 2006, rulemaking. For these reasons, EPA finds good cause under APA section 553(d)(3), for this clarification to become effective on the date of publication of this action. III. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely clarifies the nomenclature and the list of compounds excluded from the definition of VOC in the South Carolina SIP as approved in EPA's December 7, 2006, rulemaking, and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule clarifies the nomenclature and the list of compounds excluded from the definition of VOC in the South Carolina SIP as approved in EPA's December 7, 2006, rulemaking, notice and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely clarifies the nomenclature and the list of compounds excluded from the definition of VOC in the South Carolina SIP as approved in EPA's December 7, 2006, rulemaking, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, U.S.C. section 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 3, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review, nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: May 22, 2007. Russell L. Wright, Jr., Acting Regional Administrator, Region 4. [FR Doc. E7-10696 Filed 6-1-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service 42 CFR Part 136 Center for Medicare & Medicaid Services 42 CFR Part 489 [CMS-2206-F] RIN 0917-AA02 Section 506 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—Limitation on Charges for Services Furnished by Medicare Participating Inpatient Hospitals to Individuals Eligible for Care Purchased by Indian Health Programs AGENCY: Indian Health Service (IHS), Center elsewhere for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Final rule. SUMMARY: The Secretary of the Department of Health and Human Services

(HHS)hereby issues this final rule establishing regulations required by section 506 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), (Pub. L. 108-173). Section 506 of the MMA amended section 1866 (a)(1) of the Social Security Act to add subparagraph

(U)which requires hospitals that furnish inpatient hospital services payable under Medicare to participate in the contract health services program

(CHS)of the Indian Health Service

(IHS)operated by the IHS, Tribes, and Tribal organizations, and to participate in programs operated by urban Indian organizations that are funded by IHS (collectively referred to as I/T/Us) for any medical care purchased by those programs. Section 506 also requires such participation to be in accordance with the admission practices, payment methodology, and payment rates set forth in regulations established by the Secretary, including acceptance of no more than such payment rates as payment in full. DATES: These final regulations are effective July 5, 2007. FOR FURTHER INFORMATION CONTACT: Carl Harper, Director, Office of Resource Access and Partnerships, IHS, 801 Thompson Avenue, Twinbrook Metro Plaza Suite 360, Rockville, Maryland 20852, telephone

(301)443-2694. Dorothy Dupree, Director, Tribal Affairs Group, OEA, CMS, 7500 Security Boulevard, Mail Stop: C1-13-11, Baltimore, Maryland 21244, telephone

(410)786-1942. (These are not toll free numbers.) SUPPLEMENTARY INFORMATION: I. Background On April 28, 2006, IHS and CMS published proposed rules in the **Federal Register** (71 FR 25124) as mandated by section 506(c) of the MMA, which requires the Secretary to publish rules implementing the requirements of section 506 of the MMA. Under that statutory provision, hospitals that furnish inpatient hospital services payable under Medicare are required to participate both in the contract health service

(CHS)program of IHS operated by IHS, Tribes, and Tribal organizations, and in programs operated by urban Indian organizations (I/T/Us) that are funded by the IHS, for medical care purchased by those programs. Section 506 also requires such participation to be in accordance with the admission practices, payment methodology, and payment rates set forth in regulations established by the Secretary, including acceptance of no more than such rate as payment in full. The proposed rule provided interested persons until June 27, 2006 to submit written comments. II. Provisions of the Proposed Regulations a. The Proposed Rule We proposed to amend the IHS regulations at 42 CFR part 136, by adding a new subpart D to describe the payment methodology and other requirements for Medicare-participating hospitals and critical access hospitals

(CAHs)that furnish inpatient services, either directly or under arrangement, to individuals who are authorized to receive services from such hospitals under a CHS program of the IHS, Tribes, and Tribal organizations, and IHS-funded programs operated by urban Indian organizations (collectively, I/T/U programs). As provided in the statute, we also proposed to amend CMS regulations at 42 CFR part 489 to require Medicare-participating hospitals and critical access hospitals

(CAHs)that furnish inpatient hospital services to individuals who are eligible for and authorized to receive items and services covered by such I/T/U programs to accept no more than the payment methodology under 42 CFR part 136, subpart D as payment in full for such items and services. The proposed rule did not include additional regulation of admission practices. b. Summary of Changes in the Final Rule In reviewing several comments, IHS and CMS determined that the payment methodology in the proposed rule was not adequately explained. Therefore, we are clarifying the payment methodologies established by this regulation to include more detail. For hospital services that would be paid under prospective payment systems

(PPS)by the Medicare program, the basic payment methodology under this rule is based on the applicable PPS. For example, inpatient hospital services of acute care hospitals, psychiatric hospitals, rehabilitation hospitals, and long-term care hospitals will be paid based on the same four Medicare PPS systems as would be used to pay for similar hospital services to the hospitals' Medicare patients, as described under 42 CFR part 412, while outpatient hospital services and skilled nursing facility services

(SNF)will be paid based on their Medicare PPS systems, as described under 42 CFR part 419 (outpatient) and 42 CFR part 413

(SNF)respectively. The basic payment methodology under this rule for Medicare-participating hospitals that furnish inpatient services but are exempt from PPS and currently receive reasonable cost reimbursement under the Medicare program (for example, critical access hospitals (CAHs), children's hospitals, cancer hospitals, and certain other hospitals reimbursed by Medicare under special arrangements), is based on 42 CFR part 413, which addresses reasonable cost reimbursement. In addition, based on the comments received, IHS and CMS determined that the requirement that providers participate in IHS and Tribal CHS programs and IHS-funded urban Indian organization programs was not clear in the proposed rule and additional guidance was needed. Therefore, we clarified that hospitals participating in Medicare that furnish inpatient hospital services will be required to accept the payment methodology and no more than the rates established under 42 CFR part 136, subpart D as payment in full for such services. This change also clarifies that such hospitals may not refuse service to an individual on the basis that the individual may be eligible for payment under such CHS and IHS-funded urban Indian programs. We did not include additional prohibitions on discrimination in admission practices because such requirements are already covered and enforced by the HHS Office for Civil Rights under existing regulations at 45 CFR part 80. III. Analysis of and Responses to Public Comments The IHS received 35 comments from Tribes, Tribal organizations, hospital associations, CAHs, and individuals. The IHS, in partnership with CMS, carefully reviewed the submissions by individuals, groups, Indian, and non-Indian organizations. We did not consider 4 of these comments, because they were received after the closing date. Of the 31 timely comments, 26 comments supported the proposed regulation. Several comments requested clarification of certain sections of the rule. *Comment:* We received 10 comments that expressed serious concern regarding the long delay in publication of the proposed rule and requested expedited publication of a final rule. *Response:* The development of this final rule has been a long and careful process, involving consultation with the Tribes through the CMS Tribal Technical Advisory Group, and close collaboration between IHS and CMS. An incidental benefit of this process has been greater understanding by all parties of the service delivery and payment processes that are at issue in this rule. *Comment:* A number of the comments from Tribes and Tribal organizations expressed concerns that affected Indian health programs would need training to fully implement and monitor the participation and payment requirements. *Response:* IHS is authorized to provide technical assistance regarding implementation of this final rule. Tribal program representatives can contact Mr. Carl Harper at the phone number listed in the contact information. *Comment:* One commenter expressed concern that American Indian/Alaska Native (AI/AN) populations have many complications and co-morbidities that do not exist to the same extent in the patient population as a whole, including diabetes, cardiovascular disease, injury, trauma, and alcoholism. The commenter suggested that costs to treat this population are higher and suggested IHS would be paying less for its patient population than Medicare actually pays for services furnished to a comparable population. *Response:* Patients who are more seriously ill tend to require a higher level of hospital resources than patients who are less seriously ill even though they may be admitted to the hospital for the same reason. Recognizing this, Medicare payments can be higher for patients in certain diagnostic-related groups

(DRGs)based on a secondary diagnosis that could indicate specific complications or co-morbidities. Also, the DRG groupings take into consideration co-morbidity factors, and payment adjustments that would be available to reflect the higher costs of disproportionate share hospital adjustments and outlier payments are provided for exceptionally high cost cases, all of which would address high costs of this patient population. As a result, IHS payment under this rule will reflect the serious health issues faced by its patient population. *Comment:* One commenter expressed concern that the CHS program payments are not always timely and should be paid in accordance with Medicare timeline requirements. *Response:* This regulation addresses practices, payment methodologies, and rates of payment that are not already addressed under current laws or regulations. The time frame for paying claims authorized by IHS under the CHS program is already governed by section 220 of the Indian Health Care Improvement Act (IHCIA). *Comment:* One commenter expressed concern that payment for services should be absolute for services rendered, not at the service unit's discretion. In addition, this commenter suggested IHS set the timeline for notification of emergency services at a minimum of 30 days following services rendered. *Response:* Payment for services is based on a medical priority system which is based on the availability of funds as established under 42 CFR part 136, subpart C. Under subpart C of title 42, notification of emergency services must be provided within 72 hours after the beginning of treatment or admission to a health care facility. The timeline for notification of emergency services for the elderly and disabled is currently set at 30 days in accordance with section 406 of the IHCIA. *Comment:* One commenter expressed concern that the proposed rule places an additional burden on hospitals by capping rates paid to public and private non-IHS funded hospitals, with no additional responsibility or accountability placed on I/T/U programs regarding payments to such hospitals. *Response:* This rule would provide for rates that hospitals accept under the Medicare program. We do not believe these rates place an additional burden on hospitals. *Comment:* One commenter asked whether the payment rates required under this rule would apply to claims for services furnished by long-term care hospitals, independent inpatient rehabilitation facilities, and inpatient psychiatric facilities to individuals who were authorized for the service by an I/T/U program. *Response:* Long-term care hospitals, independent inpatient rehabilitation facilities, and inpatient psychiatric facilities are covered by these rules because they meet the criteria of section 506 of the MMA: They are covered by the definition of “hospital” in section 1861(e) or (f), as applicable, of the Social Security Act and they furnish inpatient hospital services. They will be paid based upon their respective Medicare PPS systems. *Comment:* A commenter asked whether agents will be precluded from charging the I/T/U for the records needed for payment determination or quality assurance in cases in which a facility is using an outside agent to manage its medical records and patient information. *Response:* Under section 136.30(j), additional payment would not be available for the cost of copying of medical records to an outside agent who manages medical records and patient information. *Comment:* One commenter expressed concern that the proposed rule does not clearly define what it means to “participate” in programs operated by IHS, Tribes, Tribal organizations, or urban Indian (I/T/U) programs. *Response:* Participation in I/T/U programs means that all hospitals covered by this rule must accept the admission practices, payment methodology, and no more than the rates of payment established under this rule as payment in full for items and services purchased by I/T/U programs for individuals eligible for and referred by such programs. To clarify that acceptance of these requirements is mandatory for participation in Medicare, IHS has revised the proposed rule in two ways. First, subsections

(a)and

(b)of 42 CFR 136.30 have been amended to clarify which entities are affected by the rule and the services that will be covered. Second, 42 CFR 489.29 has also been amended to be consistent with 42 CFR part 136, subpart D. Paragraph

(b)has been added to 42 CFR 489.29 to clarify that hospitals cannot deny services to an individual on the basis that payment for such services is authorized by an I/T/U program. However, the rule does not provide additional regulation of discrimination in admission practices because such requirements are already covered and enforced by the HHS Office for Civil Rights under existing regulations at 45 CFR part 80. *Comment:* One commenter asked whether hospitals which are not reimbursed on a reasonable cost basis will be reimbursed based on the Medicare DRGs or other prospective payment rate. *Response:* We have clarified the payment methodology in the final rule in response to this comment. We are clarifying that, for hospital services that would be paid under prospective payment systems

(PPS)by the Medicare program, the basic payment methodology under this rule is based on the applicable PPS. For example, inpatient services furnished by acute care hospitals, psychiatric hospitals, rehabilitation hospitals, and long-term care hospitals will be paid based on their respective PPS used in the Medicare program to pay for similar hospital services to the hospitals' Medicare patients, as described under 42 CFR part 412, while outpatient hospital services and skilled nursing facility

(SNF)services will be paid based on their Medicare PPS, as described under 42 CFR part 419 (outpatient) and 42 CFR part 413

(SNF)respectively. Under the basic payment methodology of this rule for Medicare-participating hospitals that furnish inpatient services but are exempt from PPS and currently receive reasonable cost reimbursement under the Medicare program (for example, CAHs, children's hospitals, cancer hospitals, and certain other hospitals reimbursed by Medicare under special arrangements), I/T/Us will reimburse such hospitals for claims in accordance with 42 CFR part 413, which addresses reasonable cost reimbursement. In other words, hospitals reimbursed by Medicare on a reasonable cost basis will not be paid by use of DRGs or other case classification systems used under the various Medicare PPS payment methods. To clarify what hospitals can expect to receive as reimbursements, IHS has created two basic payment determinations under section 136.30(c) in the final rule; one for PPS based payments and one for payments based on reasonable costs. *Comment:* Two commenters recommended that payment adjustments for organ acquisition costs, blood clotting factors, new technology services, and disproportionate share be included in the interim payment calculations in order to provide for an appropriate level of reimbursement. *Response:* IHS agrees that payment adjustments for the types of services listed above should be included in the payment calculations in order to provide for an appropriate level of reimbursement. Payment adjustments for disproportionate share and new medical technology already are included in the PPS methodology under subparts F and G of part 412. Moreover, to ensure that hospitals receiving PPS payment include these payment adjustments, IHS will use the Medicare PRICER system (or a similar system) in calculating final payment. The system includes adjustments such as those above. For items not adjusted within the system, the IHS fiscal intermediary will be instructed to use standard payments calculated by CMS (for example, payments based on the Average Sales Price

(ASP)for hemophilia clotting factors). To clarify that such payments will be added to the basic rate calculation, IHS has added a new section 136.30(d) to the rule. *Comment:* Several commenters expressed concern that the interim payment rates will have a financial impact on CAHs. Another commenter expressed concern about the per diem mechanism used to make interim payments to CAHs because there is no requirement to follow Medicare regulations by the I/T/U. *Response:* The economic financial impact study conducted by an IHS fiscal intermediary demonstrates that the interim payment rates will have limited financial impact on rural and small rural hospitals as explained in section VI of this final rule, Regulatory Impact Statement. Moreover, in revising the proposed adoption of the Medicare payment methodologies in section 136.30(c) of the final rule, IHS has identified two basic determinations for payment. Payments to CAHs are covered under section 136.30(c)(2). IHS will follow payment guidance based on the reasonable cost methodology under 42 CFR 413.70, “Payment for services of a CAH”. As with other payments based on reasonable cost, payments to CAHs will be based on the interim payment rate established under 42 CFR part 413, subpart E. *Comment:* One commenter asked whether the final rule will be applied to claims which are received after the effective date, regardless of the date of service, or only to claims with a date of service after the effective date. *Response:* The requirements of the final rule will apply to claims with a date of service on or after the effective date of the final regulation. *Comment:* A commenter asked whether contracts will become invalidated by this regulation or remain in effect until they expire in situations in which a hospital contract is currently in place with IHS, which has rates that are not based on Medicare or are not less than Medicare rates. *Response:* Medicare-participating hospitals that furnish inpatient services must accept the rate methodology established under this regulation as a condition of participation in the Medicare program. Current hospital contract rates that are lower than the rates established by this regulation will continue to apply in accordance with section 136.30(c). *Comment:* One commenter asked if the Medicare timely filing guidelines will be waived and/or modified for claims when the I/T/U

(1)is not the primary payor and the patient has alternate resources or,

(2)delayed in sending out a timely purchase order. *Response:* Under 42 CFR 136.61, as applied in this rule, the I/T/U program is the payor of last resort for individuals eligible for any alternate resources. The timely filing period under 42 CFR 424.44 and provisions of the Medicare Claims Processing Manual will apply to all claims submitted to an I/T/U program for payment. *Comment:* One commenter asked the IHS to remove the Health Insurance Portability and Accountability Act (HIPAA) requirement for electronic claim submission. *Response:* If the I/T/U program accepts paper claims, this is still an acceptable format for claims submission. However, if non-I/T/U providers generally submit their claims electronically to other payers, they should also do so for I/T/U payers that accept electronic claims. HIPAA requires electronic claims to be filed using the standard 837 format. IV. Collection of Information Requirements This document does not impose any new 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). **Note:** The burden requirements in section 136.30(h)(1) for submitting a claim form are currently approved under OMB approval number 0938-0279. V. Regulatory Impact Statement The IHS has examined the impact 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 Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 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 1 year). This action is not a significant regulatory action under Executive Order 12866. Further regulatory evaluation is not necessary because the economic impact will be minimal. 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 government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. The I/T/Us have entered into contracts with many public and private non-I/T Medicare-participating hospitals at rates less than or equal to the rate proposed in this rule. IHS intends to continue existing contracts with these hospitals; however, to the extent that I/T/Us are not able to negotiate a contract with a hospital, payment rates established by this rule will apply. This action will alleviate the need for and administrative burden of negotiating rates through individual contracts by IHS as well as the Medicare-participating hospitals. The IHS conducted a study to determine the financial impact the interim payment rates, as proposed by this regulation, would have on public and private non-I/T/U hospitals. As part of this study, IHS compared the interim rates to the rates that IHS has negotiated per contracts with public and private non-I/T/U hospitals. For FY 2003, of the 387 hospitals that IHS does business with, IHS has negotiated contracts with 48 percent of these hospitals. Based on IHS data, the findings revealed the overall negative impact on these public and private non-I/T/U hospitals would be less than 1 percent. Of the 387 hospitals in the study, 105 are rural hospitals. Out of the 105 rural hospitals, 84 are small rural hospitals (less than 100 beds). By comparing the interim rate to full billed charges, (that is, what IHS pays if a contract is not negotiated) revealed a negative financial impact of 8 percent on these rural hospitals. Further analysis of the inpatient bed utilization by hospital revealed IHS represents less than 2 percent of the rural and small rural hospitals total business meaning that 98 percent of the hospitals' income comes from other sources. For these reasons, IHS has determined that the rates proposed by these regulations will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. In addition, section 1102(b) of the Act requires IHS 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 603 of the RFA. For purposes of section 1102(b) of the Act, IHS defines a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. For the reasons provided above, IHS has determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose requirements mandate expenditure in any 1 year by State, local, or Tribal governments, in the aggregate, or by the private sector, of $120 million. This proposal would not impose substantial Federal mandates on State, local or Tribal governments or private sector. Executive Order 13132 establishes certain requirements that an Agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. It has been determined that this action would 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, and therefore would not have Federalism implications. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance) List of Subjects 42 CFR Part 136 American Indian, Alaska Natives, Health, Medicare. 42 CFR Part 489 Health facilities, Medicare, Reporting and recordkeeping requirements. Dated: November 2, 2006. Charles W. Grim, Assistant Surgeon General, Director, Indian Health Service. Dated: November 16, 2006. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: April 18, 2007. Michael O. Leavitt, Secretary. The Indian Health Service is amending 42 CFR Chapter I as set forth below: PART 136—INDIAN HEALTH 1. The authority citation for part 136 continues to read as follows: Authority: 25 U.S.C. 13; 42 U.S.C. 1395cc(a)(1)(U), 42 U.S.C. 2001 and 2003, unless otherwise noted. 2. Add new subpart D consisting of §§ 136.30 through 136.32, to read as follows: Subpart D—Limitation on Charges for Services Furnished by Medicare-Participating Hospitals to Indians Sec. 136.30 Payment to Medicare-participating hospitals for authorized Contract Health Services. 136.31 Authorization by urban Indian organization. 136.32 Disallowance. Subpart D—Limitation on Charges for Services Furnished by Medicare-Participating Hospitals to Indians § 136.30 Payment to Medicare-participating hospitals for authorized Contract Health Services.

(a)*Scope.* All Medicare-participating hospitals, which are defined for purposes of this subpart to include all departments and provider-based facilities of hospitals (as defined in sections 1861(e) and

(f)of the Social Security Act) and critical access hospitals (as defined in section 1861(mm)(1) of the Social Security Act), that furnish inpatient services must accept no more than the rates of payment under the methodology described in this section as payment in full for all items and services authorized by IHS, Tribal, and urban Indian organization entities, as described in paragraph

(b)of this section.

(b)*Applicability.* The payment methodology under this section applies to all levels of care furnished by a Medicare-participating hospital, whether provided as inpatient, outpatient, skilled nursing facility care, as other services of a department, subunit, distinct part, or other component of a hospital (including services furnished directly by the hospital or under arrangements) that is authorized under part 136, subpart C by a contract health service

(CHS)program of the Indian Health Service (IHS); or authorized by a Tribe or Tribal organization carrying out a CHS program of the IHS under the Indian Self-Determination and Education Assistance Act, as amended, Pub. L. 93-638, 25 U.S.C. 450 *et seq.* ; or authorized for purchase under § 136.31 by an urban Indian organization (as that term is defined in 25 U.S.C. 1603(h)) (hereafter “I/T/U”).

(c)*Basic determination.*

(1)Payment for hospital services that the Medicare program would pay under a prospective payment system

(PPS)will be based on that PPS. For example, payment for inpatient hospital services shall be made per discharge based on the applicable PPS used by the Medicare program to pay for similar hospital services under 42 CFR part 412. Payment for outpatient hospital services shall be made based on a PPS used in the Medicare program to pay for similar hospital services under 42 CFR part 419. Payment for skilled nursing facility

(SNF)services shall be based on a PPS used in the Medicare program to pay for similar SNF services under 42 CFR part 413.

(2)For Medicare participating hospitals that furnish inpatient services but are exempt from PPS and receive reimbursement based on reasonable costs (for example, critical access hospitals (CAHs), children's hospitals, cancer hospitals, and certain other hospitals reimbursed by Medicare under special arrangements), including provider subunits exempt from PPS, payment shall be made per discharge based on the reasonable cost methods established under 42 CFR part 413, except that the interim payment rate under 42 CFR part 413, subpart E shall constitute payment in full for authorized charges.

(d)*Other payments.* In addition to the amount payable under paragraph (c)(1) of this section for authorized inpatient services, payments shall include an amount to cover: The organ acquisition costs incurred by hospitals with approved transplantation centers; direct medical education costs; units of blood clotting factor furnished to an eligible patient who is a hemophiliac; and the costs of qualified non-physician anesthetists, to the extent such costs would be payable if the services had been covered by Medicare. Payment under this subsection shall be made on a per discharge basis and will be based on standard payments established by the Centers for Medicare & Medicaid Services

(CMS)or its fiscal intermediaries.

(e)*Basic payment calculation.* The calculation of the payment by I/T/Us will be based on determinations made under paragraphs

(c)and

(d)of this section consistent with CMS instructions to its fiscal intermediaries at the time the claim is processed. Adjustments will be made to correct billing or claims processing errors, including when fraud is detected. I/T/Us shall pay the providing hospital the full PPS based rate, or the interim reasonable cost rate, without reduction for any co-payments, coinsurance, and deductibles required by the Medicare program from the patient.

(f)*Exceptions to payment calculation.* Notwithstanding paragraph

(e)of this section, if an amount has been negotiated with the hospital or its agent by the I/T/U, the I/T/U will pay the lesser of: The amount determined under paragraph

(e)of this section or the amount negotiated with the hospital or its agent, including but not limited to capitated contracts or contracts per Federal law requirements;

(g)*Coordination of benefits and limitation on recovery.* If an I/T/U has authorized payment for items and services provided to an individual who is eligible for benefits under Medicare, Medicaid, or another third party payor—

(1)The I/T/U shall be the payor of last resort under § 136.61;

(2)If there are any third party payers, the I/T/U will pay the amount for which the patient is being held responsible after the provider of services has coordinated benefits and all other alternative resources have been considered and paid, including applicable co-payments, deductibles, and coinsurance that are owed by the patient; and

(3)The maximum payment by the I/T/U will be only that portion of the payment amount determined under this section not covered by any other payor; and

(4)The I/T/U payment will not exceed the rate calculated in accordance with paragraph

(e)of this section or the contracted amount (plus applicable cost sharing), whichever is less; and

(5)When payment is made by Medicaid it is considered payment in full and there will be no additional payment made by the I/T/U to the amount paid by Medicaid (except for applicable cost sharing).

(h)*Claims processing.* For a hospital to be eligible for payment under this section, the hospital or its agent must submit the claim for authorized services—

(1)On a UB92 paper claim form (until abolished, or on an officially adopted successor form) or the HIPAA 837 electronic claims format ANSI X12N, version 4010A1 (until abolished, or on an officially adopted successor form) and include the hospital's Medicare provider number/National Provider Identifier; and

(2)To the I/T/U, agent, or fiscal intermediary identified by the I/T/U in the agreement between the I/T/U and the hospital or in the authorization for services provided by the I/T/U; and

(3)Within a time period equivalent to the timely filing period for Medicare claims under 42 CFR 424.44 and provisions of the Medicare Claims Processing Manual applicable to the type of item or service provided.

(i)*Authorized services.* Payment shall be made only for those items and services authorized by an I/T/U consistent with part 136 of this title or section 503(a) of the Indian Health Care Improvement Act (IHCIA), Public Law 94-437, as amended, 25 U.S.C. 1653(a).

(j)*No additional charges.* A payment made in accordance with this section shall constitute payment in full and the hospital or its agent may not impose any additional charge—

(1)On the individual for I/T/U authorized items and services; or

(2)For information requested by the I/T/U or its agent or fiscal intermediary for the purposes of payment determinations or quality assurance. § 136.31 Authorization by urban Indian organization. An urban Indian organization may authorize for purchase items and services for an eligible urban Indian (as those terms are defined in 25 U.S.C. 1603(f) and (h)) according to section 503 of the IHCIA and applicable regulations. Services and items furnished by Medicare-participating inpatient hospitals shall be subject to the payment methodology set forth in § 136.30. § 136.32 Disallowance.

(a)If it is determined that a hospital has submitted inaccurate information for payment, such as admission, discharge or billing data, an I/T/U may as appropriate—

(1)Deny payment (in whole or in part) with respect to any such services, and;

(2)Disallow costs previously paid, including any payments made under any methodology authorized under this subpart. The recovery of payments made in error may be taken by any method authorized by law.

(b)For cost based payments previously issued under this subpart, if it is determined that actual costs fall significantly below the computed rate actually paid, the computed rate may be retrospectively adjusted. The recovery of overpayments made as a result of the adjusted rate may be taken by any method authorized by law. The Centers for Medicare & Medicaid Services is amending 42 CFR Chapter IV, as set forth below: PART 489—PROVIDER AGREEMENTS AND SUPPLIER APPROVAL 3. The authority citation for part 489 continues to read as follows: Authority: Sec. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart B—Essentials of Provider Agreements 4. A new § 489.29 is added to subpart B to read as follows: § 489.29 Special requirements concerning beneficiaries served by the Indian Health Service, Tribal health programs, and urban Indian organization health programs.

(a)Hospitals (as defined in sections 1861(e) and

(f)of the Social Security Act) and critical access hospitals (as defined in section 1861(mm)(1) of the Social Security Act) that participate in the Medicare program and furnish inpatient hospital services must accept the payment methodology and no more than the rates of payment established under 42 CFR part 136, subpart D as payment in full for the following programs:

(1)A contract health service

(CHS)program under 42 CFR part 136, subpart C, of the Indian Health Service (IHS);

(2)A CHS program under 42 CFR part 136, subpart C, carried out by an Indian Tribe or Tribal organization pursuant to the Indian Self-Determination and Education Assistance Act, as amended, Public Law 93-638, 25 U.S.C. 450 *et seq.* ; and

(3)A program funded through a grant or contract by the IHS and operated by an urban Indian organization under which items and services are purchased for an eligible urban Indian (as those terms are defined in 25 U.S.C. 1603

(f)and (h)).

(b)Hospitals and critical access hospitals may not refuse service to an individual on the basis that the payment for such service is authorized under programs described in paragraph

(a)of this section. [FR Doc. 07-2740 Filed 6-1-07; 8:45 am]

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