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Code · REGISTER · 2008-06-27 · Federal Aviation Administration (FAA), DOT · Rules and Regulations

Rules and Regulations. Direct final rule; confirmation of effective date

103,344 words·~470 min read·/register/2008/06/27/08-1396

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BILLING CODE 3410-08-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2008-0163; Airspace Docket No. 08-AGL-2] Amendment of Class E Airspace; Indianapolis, IN AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Direct final rule; confirmation of effective date. SUMMARY: This action confirms the effective date of a direct final rule that establishes additional Class E airspace at Indianapolis, IN, published in the **Federal Register** April 2, 2008 (73 FR 17887) Docket No.
FAA-2008-0163. This action also makes a minor correction to the geographic coordinates of Hendricks County Gordon Graham Field. DATES: *Effective Date:* 0901 UTC June 27, 2008. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Gary Mallett, NISC Contractor, Operations Support Group, ATO Central Service Center, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd, Fort Worth, TX 76193-0530; at telephone
(817)222-4949. SUPPLEMENTARY INFORMATION: History The FAA published a direct final rule with request for comments in the **Federal Register** April 2, 2008, (73 FR 17887), Docket No. FAA-2008-0163, that establishes additional Class E airspace at Indianapolis, IN. The FAA uses the direct final rule procedure for non-controversial rules where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit an adverse comment, was received within the comment period, the regulation would become effective on June 5, 2008. No adverse comments were received; thus, this notice confirms that the direct final rule will become effective on this date. Also an error was found in the geographic coordinates of Hendricks County Gordon Graham Field. This action corrects that error. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9R, Airspace Designations and Reporting Points, signed August 15, 2007, and effective September 15, 2007, is hereby amended as follows: Correction In the **Federal Register** dated April 2, 2008, (73 FR 14887), **Federal Register** Docket No. FAA-2008-0163, on page 17888, column 2, line 47, replace the coordinates for Hendricks County- Gordon Graham Field as follows: (Lat. 39°44′48″ N, Long. 86°28′31″ W). Issued in Fort Worth, TX on June 17, 2008. Donald R. Smith, Manager, Operations Support Group, ATO Central Service Center. [FR Doc. E8-14381 Filed 6-26-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2007-0309; Airspace Docket No. 07-AEA-20] Amendment of Class E Airspace; Gettysburg, PA AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Direct final rule, confirmation of effective date. SUMMARY: This action confirms the effective date of a direct final rule published in the **Federal Register** (73 FR 8593) that modifies Class E Airspace at Gettysburg, PA. Additional controlled airspace at Gettysburg Regional Airport will now provide the controlled airspace required to support the new Copter Area Navigation
(RNAV)Global Positioning System
(GPS)070 Point in Space
(PinS)approach developed to facilitate helicopter medical flight arrivals and departures at Gettysburg Hospital, Gettysburg, PA. DATES: Effective 0901 UTC June 27, 2008. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; Telephone
(404)305-5610; Fax
(404)305-5572. SUPPLEMENTARY INFORMATION: Confirmation of Effective Date The FAA published this direct final rule with a request for comments in the **Federal Register** on February 14, 2008 (73 FR 8593), Docket No. FAA 2007-0309; Airspace Docket No. 07-AEA-20. The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on June 5, 2009. No adverse comments were received, and this notice confirms that effective date. Issued in College Park, Georgia, on May 19, 2008. Barry A. Knight, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. E8-14384 Filed 6-26-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2008-0131; Airspace Docket 08-AEA-12] Establishment of Class E Airspace; Philippi, WV AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action establishes Class E airspace at Philippi, WV, to accommodate a new Area Navigation
(RNAV)Global Positioning System
(GPS)Standard Instrument Approach Procedures
(SIAP)Runways
(RWY)08-26 that has been developed for Philippi/Barbour County Regional Airport. As a result, controlled airspace extending upward from 700 feet Above Ground Level
(AGL)is needed to contain the SIAP and for Instrument Flight Rule
(IFR)operations at Philippi/Barbour County Regional Airport. The operating status of the airport will change from Visual Flight Rules
(VFR)to include IFR operations concurrent with the publication of the SIAP. DATES: Effective Date: 0901 UTC, September 25, 2008. The Director of the Federal Register approves this incorporation by reference action under title 1 Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Daryl Daniels, Airspace Specialist, System Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone
(404)305-5581. SUPPLEMENTARY INFORMATION: History On March 18, 2008, the FAA proposed to amend Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace at Philippi, WV (73 FR 14408). This action provides adequate Class E airspace for IFR operations at Philippi/Barbour County Regional Airport. Designations for Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in FAA Order 7400.9R, dated August 15, 2007, and effective September 15, 2007, which is incorporated by reference in 14 CFR part 71.1. The Class E designations listed in this document will be published subsequently in the Order. Interested parties were invited to participate in this rulemaking by submitting comments on the proposal to the FAA. No comments objecting to the proposal were received. The Rule This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace at Philippi, WV, to provide controlled airspace required to support the new Area Navigation
(RNAV)Global Positioning System
(GPS)Standard Instrument Approach Procedures
(SIAP)Runways 08-26 that have been developed for Philippi/Barbour County Regional Airport. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore,
(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)does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows: PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for Part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9R, Airspace Designations and Reporting Points, signed August 15, 2007, and effective September 15, 2007, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward from 700 feet or More Above the Surface of the Earth. AEA WV E5 Philippi, WV [NEW] Philippi/Barbour County Regional Airport, WV (Lat. 39°09′58″ N, long. 80°03′45″ W) That airspace extending upward from 700 feet above the surface of the earth within a 6.6-mile radius of Philippi/Barbour County Regional Airport. Issued in College Park, Georgia, on June 4, 2008. Mark D. Ward, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. E8-14164 Filed 6-26-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 95 [Docket No. 30615; Amdt. No. 475] IFR Altitudes; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas. DATES: *Effective Date:* 0901 UTC, July 31, 2008. FOR FURTHER INFORMATION CONTACT: Donald P. Pate, Flight Procedure Standards Branch (AMCAFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125), telephone:
(405)954-4164. SUPPLEMENTARY INFORMATION: This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points
(COPs)for Federal airways, jet routes, or direct routes as prescribed in part 95. The Rule The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 95 Airspace, Navigation (air). Issued in Washington, DC on June 20, 2008. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, July 31, 2008. PART 95—[AMENDED] 1. The authority citation for part 95 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44719, 44721. 2. Part 95 is amended to read as follows: Revisions to IFR Altitudes & Changeover Points Amendment 475 Effective Date July 31, 2008 From/To Total distance Changeover distance Point from Track angle MEA MAA § 95.5000 Ground-Based High Altitude RNAV Routes is Amended to Delete J888R Amott, AK RP 107.0 75 AMOTT 245/065 TO COP 28000 45000 Malos, AK WP 244/064 TO MALOS Malos, AK WP 59.0 32 MALOS 243/063 TO COP 28000 45000 Mousy, AK WP 241/061 TO MOUSY Mousy, AK WP 196.0 28000 45000 Ozzie, AK WP 230/050 TO OZZIE J996R Cape Newenham, AK 25000 45000 NDB/DME NERKA, AK WP NERKA, AK WP 129.0 18000 45000 CARBU, AK WP 047/227 TO CARBU CARBU, AK WP 114.0 11 CARBU 047/227 TO COP 18000 45000 FROM TO MEA § 95.1001 Direct Routes—U.S. Color Routes § 95.4 Green Federal Airway G2 is Amended To Read in Part Borland, AK NDB/DME Woody Island, AK NDB *10000 *6600—MOCA § 95.6001 Victor Routes—U.S. § 95.6004 VOR Federal Airway V4 Kansas City, MO VORTAC Lexin, MO FIX 2600 Lexin, MO FIX Hallsville, MO VORTAC *6000 *3000—GNSS MEA § 95.6026 VOR Federal Airway V26 is Amended To Read in Part Huron, SD VORTAC Obitt, SD FIX *5000 *4000—GNSS MEA Obitt, SD FIX Ghent, MN FIX *6000 *4000—GNSS MEA Ghent, MN FIX Redwood Falls, MN VOR/DME *5000 *4000—GNSS MEA § 95.6055 VOR Federal Airway V55 is Amended To Read in Part Eau Claire, WI VORTAC Siren, WI VOR/DME *5000 *2800—MOCA *3000—GNSS MEA Siren, WI VOR/DME Brainerd, MN VORTAC *6000 *2800—MOCA *3000—GNSS MEA § 95.6071 VOR Federal Airway V71 is Amended To Read in Part Hot Springs, AR VOR/DME Ollas, AR FIX *3600 *3100—MOCA Ollas, AR FIX Haawk, AR FIX *4500 *2500—MOCA Haawk, AR FIX Harrison, AR VOR/DME *10000 *3700—MOCA *4000—GNSS MEA § 95.6077 VOR Federal Airway V77 is Amended To Read in Part Will Rogers, OK VORTAC Castn, OK FIX 3500 Castn, OK FIX Wendy, OK FIX 4000 Wendy, OK FIX Pioneer, OK VORTAC 2900 § 95.6082 VOR Federal Airway V82 is Amended To Read in Part Farmington, MN VORTAC *Cordy, MN FIX 3000 *4000—MRA *Cordy, MN FIX Rochester, MN VOR/DME 3000 *4000—MRA § 95.6134 VOR Federal Airway V134 is Amended To Read in Part Grand Junction, CO VORTAC Paces, CO FIX 11500 Paces, CO FIX Slolm, CO FIX 13000 Slolm, CO FIX *Gleno, CO FIX 14000 *16000—MRA *Gleno, CO FIX Red Table, CO VOR/DME 14000 *16000—MRA § 95.6148 VOR Federal Airway V148 is Amended To Read in Part Gopher, MN VORTAC Aleen, WI FIX *5000 *2700—MOCA § 95.6161 VOR Federal Airway V161 is Amended To Read in Part Rochester, MN VOR/DME *Cordy, MN FIX 3000 *4000—MRA *Cordy, MN FIX Farmington, MN VORTAC 3000 *4000—MRA § 95.6203 VOR Federal Airway V203 is Amended To Read in Part Albany, NY VORTAC Otole, NY FIX *6000 *2200—MOCA *3000—GNSS MEA Otole, NY FIX Dinny, NY FIX *10000 *6900—MOCA *7000—GNSS MEA § 95.6214 VOR Federal Airway V214 is Amended To Read in Part Dupont, DE VORTAC Yardley, PA VOR/DME *6000 *3000—GNSS MEA § 95.6220 VOR Federal Airway V220 is Amended To Read in Part Grand Junction, CO VORTAC Paces, CO FIX 11500 § 95.6302 VOR Federal Airway V302 is Amended To Read in Part Augusta, ME VOR/DME Ancor, ME FIX *5000 *3000—GNSS MEA § 95.6374 VOR Federal Airway V374 is Amended To Read in Part Carmel, NY VOR/DME Vollu, NY FIX 2600 Vollu, NY FIX Gayel, NY FIX *5000 *3200—MOCA Gayel, NY FIX Binghamton, NY VORTAC *10000 *6000—GNSS MEA § 95.6378 VOR Federal Airway V378 is Amended To Read in Part Belay, MD FIX Troyz, MD FIX *9500 *4000—GNSS MEA Troyz, MD FIX Nuggy, PA FIX *7500 *4000—GNSS MEA Nuggy, PA FIX Modena, PA VORTAC *6000 *2000—MOCA *4000—GNSS MEA § 95.6403 VOR Federal Airway V403 is Amended To Read in Part Belay, MD FIX Spery, PA FIX *10000 *2100—MOCA *3000—GNSS MEA § 95.6405 VOR Federal Airway V405 is Amended To Read in Part Belay, MD FIX Spery, PA FIX *10000 *2100—MOCA *3000—GNSS MEA § 95.6408 VOR Federal Airway V408 is Amended To Read in Part Lake Henry, PA VORTAC Prnce, NY FIX 6000 MAA—15000 Prnce, NY FIX Sages, NY FIX 6400 MAA—15000 § 95.6430 VOR Federal Airway V430 is Amended To Read in Part Ironwood, MI VORTAC Diner, MI FIX *3500 *3400—MOCA Diner, MI FIX Iron Mountain, MI VOR/DME *5000 *3500—MOCA *4000—GNSS MEA § 95.6431 VOR Federal Airway V431 is Amended To Read in Part Keene, NH VORTAC Brats, VT FIX *4400 *3600—MOCA Glens Falls, NY VORTAC Gassy, NY FIX *10000 *6000—GNSS MEA § 95.6433 VOR Federal Airway V433 is Amended To Read in Part Dupont, DE VORTAC Yardley, PA VOR/DME *6000 *3000—GNSS MEA § 95.6445 VOR Federal Airway V445 is Amended To Read in Part Dupont, DE VORTAC Yardley, PA VOR/DME *6000 *3000—GNSS MEA § 95.6451 VOR Federal Airway V451 is Amended To Read in Part Cream, NY FIX Groton, CT VOR/DME *6000 *4000—GNSS MEA § 95.6496 VOR Federal Airway V496 is Amended To Read in Part Mallo, NY FIX Glens Falls, NY VORTAC *7000 *6000—GNSS MEA Glens Falls, NY VORTAC Kerst, VT FIX *10000 *6000—GNSS MEA § 95.6591 VOR Federal Airway V591 is Amended To Read in Part Grand Junction, CO VORTAC Paces, CO FIX 11500 Slolm, CO FIX *Gleno, CO FIX 14000 *16000—MRA *Gleno, CO FIX Snow, CO VOR/DME 14000 *16000—MRA § 95.6531 Alaska VOR Federal Airway V531 is Amended To Read in Part Huslia, AK VOR/DME Atago, AK FIX E BND *3500 W BND *4000 *2500—MOCA Atago, AK FIX Desoy, AK FIX 4000 Kotzebue, AK VOR/DME Berjo, AK FIX SE BND *2500 NW BND *8000 *2500—MOCA [FR Doc. E8-14543 Filed 6-26-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Parts 158 and 260 [Docket No. RM07-9-001; Order No. 710-A] Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines Issued June 20, 2008. AGENCY: Federal Energy Regulatory Commission. ACTION: Order Granting in Part and Denying in Part Rehearing and Granting Request for Clarification. SUMMARY: In this order on rehearing, the Commission affirms its basic determinations in Order No. 710, grants in part and denies in part rehearing and grants clarification regarding certain revisions to its forms and reporting requirements for natural gas pipelines. DATES: *Effective Date:* This Rule will become effective July 28, 2008. The revisions to FERC Form Nos. 2, 2-A, and 3-Q are applicable January 1, 2008, and February 28, 2009 for the termination of FERC Form No. 11. FOR FURTHER INFORMATION CONTACT: Michelle Veloso (Technical Information), Division of Financial Regulation, Office of Enforcement, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, Telephone:
(202)502-8363, E-mail: *michelle.veloso@ferc.gov* . Scott Molony (Technical Information), Chief Accountant, Division of Financial Regulation, Office of Enforcement, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, Telephone:
(202)502-8919, E-mail: *scott.molony@ferc.gov* . SUPPLEMENTARY INFORMATION: *Before Commissioners:* Joseph T. Kelliher, Chairman; Suedeen G. Kelly, Marc Spitzer, Philip D. Moeller, and Jon Wellinghoff. 1. This order addresses requests for rehearing and clarification of Order No. 710, a Final Rule issued on March 21, 2008, adopting revisions to the Commission's financial reporting requirements for natural gas pipelines, FERC Form Nos. 2, 2-A and 3-Q. 1 1 *Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines* , Order No. 710, 73 FR 19389 (Apr. 10, 2008), FERC Stats. & Regs. ¶ 31,267
(2008)(Final Rule). I. Background 2. On September 20, 2007, the Commission issued a Notice of Proposed Rulemaking
(NOPR)proposing changes to the financial forms and reporting requirements for natural gas pipelines. 2 The NOPR was issued following an in-depth review of financial reporting requirements for the natural gas, electric utility and oil pipeline industries in the fall of 2006. The staff's review, including outreach meetings with both form filers and users, culminated in the issuance of a Notice of Inquiry seeking comment on the need for changes or additions to the financial information reported in the Commission's quarterly and annual financial reports. 3 2 *Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines* , Notice of Proposed Rulemaking, 72 FR 54860 (Sept. 27, 2007), FERC Stats. & Regs. ¶ 32,623
(2007)(NOPR). 3 *Assessment of Information Requirements for FERC Financial Forms* , Notice of Inquiry, FERC Stats. & Regs. ¶ 35,554 (2007). 3. The changes adopted in the Final Rule were designed to enhance the transparency of financial reporting by interstate natural gas pipelines and better reflect the current market and cost information needed for the Commission's oversight of interstate natural gas pipeline rates. The Final Rule requires the forms' filers to provide additional information on costs and revenues related to the disposition of shipper-supplied gas, affiliate transactions, discounted and negotiated rate services, and deferred income tax and state tax issues. The Final Rule eliminated FERC Form No. 11 and incorporated the information contained in that form into Form Nos. 2 and 3-Q. The revisions to Form Nos. 2, 2-A and 3-Q are applicable January 1, 2008. The revised Form Nos. 2 and 2-A are required to be filed on April 30, 2009. The termination of FERC Form No. 11 is effective February 28, 2009. II. Requests for Rehearing and Clarification 4. Timely requests for clarification and/or rehearing were filed by the American Gas Association (AGA), Dominion Resources, Inc. (Dominion), the Interstate Natural Gas Association of America (INGAA), and the Kansas Corporation Commission (KCC). A. Other Gas Revenues 5. INGAA and Dominion filed requests for clarification or rehearing of the elimination of an instruction on page 308 of Form Nos. 2 and 2-A. The Final Rule revised page 308 to provide more detail regarding revenues recorded in Account 495, Other Gas Revenues. Previously, pipelines were required to report this information in the aggregate and not required to include detailed information about the nature of the business activities from which the revenues are derived. The Commission determined that it was important for users of the data to understand which customer classes or groups are affected by the miscellaneous gas revenues reported in Form Nos. 2 and 2-A. 4 Accordingly, page 308 was revised to include a breakdown of the types of revenues in Account No. 495 to be separately reported on that schedule. 5 4 *See* Order No. 710 at P 19. 5 *Id* . 6. Prior to the revisions adopted in the Final Rule, the instructions for page 308 did not require the revenue information to be broken down but simply stated that transactions (identified in the instructions) with annual revenues of $250,000 or more were to be reported in the aggregate. In the Final Rule, miscellaneous revenue was broken out into ten separate categories and the instructions for page 308, including the $250,000 threshold, were eliminated. 6 6 *Id* . at App. C, p. 308. 7. INGAA and Dominion request that the Commission reinstate the $250,000 minimum threshold contained in the instructions to page 308 prior to revision of the forms. INGAA notes that in the Final Rule, the Commission reinstated a similar minimum threshold reporting requirement for one existing schedule and inserted the same threshold reporting requirement for another. 7 The Commission agreed with commenters who argued that the absence of such minimum thresholds could add a substantial burden to the forms' filers. 8 We grant rehearing. We agree that a similar burden could be imposed on filers absent the change sought by INGAA and Dominion. Accordingly, we will reinstate a minimum reporting threshold for page 308 and clarify that the reporting requirements for the ten categories of discrete miscellaneous revenues listed thereon be limited to transactions with annual revenues of $250,000 or greater. 7 *Id* . P 22 (pages 357-8 of Form 2). 8 *Id* . 9 *Id* . P 16. B. Shipper-Supplied Gas 8. The Final Rule adopted two new schedules to require natural gas companies to provide detailed information regarding the acquisition and disposition of shipper-supplied gas. 9 The Commission noted that, despite existing accounting and reporting requirements for gas used in operations, gas lost, and gas sold, Form Nos. 2 and 2-A users are unable to readily determine the disposition and value of shipper-supplied gas that exceeds the pipelines' operational needs or the source and cost of any gas acquired to meet deficiencies in shipper-supplied gas. 10 Given the rising cost of gas and a lack of detailed, current information, the Commission adopted new schedules for Form Nos. 2, 2-A and 3-Q to require the following information:
(1)The difference between the volume of gas received from shippers and the volume of gas consumed in pipeline operations each month;
(2)the disposition of any excess and the accounting recognition given to such disposition including the basis of valuing the gas and the specific accounts charged or credited; and
(3)the source of gas used to meet any deficiency and the accounting recognition given to the gas used to meet the deficiency, including the accounting basis of the gas and the specific account(s) charged or credited. 11 10 *See* NOPR at P 37. 11 *Id* . P 39. 9. The Final Rule declined to adopt additional information requirements related to shipper-supplied gas and concluded that the requested information was already available to the forms' users or that adding requirements might upset the delicate balance between burden and benefit. 12 On rehearing, AGA argues that the Commission erred by failing to adopt AGA's suggestion that the new information reported on pages 521a and 521b of Form Nos. 2, 2-A and 3-Q should be broken down by function and include, by function, the amount of fuel that has been waived, discounted, or reduced as part of a negotiated rate agreement. 13 The Commission declined to adopt the additional detail requested by AGA, pointing out that certain fuel information, broken out by function, is already available on page 520 of Form Nos. 2 and 2-A. 14 12 Order No. 710 at P 16. 13 AGA Request for Rehearing at 2. 14 Order No. 710 at P 16. 10. AGA's request for rehearing argues that, while page 520 of the form provides certain fuel information by function, the information is not adequate to enable a form user to determine where on the pipeline system fuel costs are being incurred and how they are being allocated. 15 As stated in the Final Rule, Page 520 of Form Nos. 2 and 2-A provides fuel losses by function (unaccounted for gas is broken out by function at lines 30-34). 16 AGA argues that additional detail regarding fuel costs is required for schedules 521a and 521b to ensure that the Commission and pipeline customers have the information required to assess the justness and reasonableness of pipeline rates. 17 The Final Rule approved extensive revisions to Form Nos. 2, 2-A and 3-Q with respect to the disposition of shipper supplied gas, adding two new schedules to the forms to accommodate the information collection. 18 INGAA and other pipeline commenters objected to the changes as burdensome, but the Commission deemed the collection of this information critical in light of the increased impact on the pipeline's cost of service as a result of rising gas prices. 19 At the same time, the Commission noted that the need to provide greater transparency with regard to fuel costs had to be balanced with the additional reporting burdens placed on the pipeline, and the Commission approved the new schedules as a fair reflection of this balance. 20 In addition, the Commission stated that some of the information sought by AGA, i.e., certain data broken out by function, is already available on page 520 of Form Nos. 2 and 2-A and the Final Rule added page 520 to Form No. 3-Q as well. While the detail sought by AGA might provide additional clarity with respect to fuel costs, we do not believe its exclusion will preclude the Commission's or customers' ability to assess the justness and reasonableness of pipeline rates. 15 AGA Request for Rehearing at 5. 16 Order No. 710 at P 16. 17 *See* AGA Request for Rehearing at 5-6. 18 *See* Order No. 710 at P 16. 19 *Id. See also Public Service Commission of New York, Pennsylvania Public Utility Commission and Pennsylvania Office of Consumer Advocate* v. *National Fuel Gas Supply Corp.* , 115 FERC ¶ 61,299 (2006), *order approving uncontested settlement* , 118 FERC ¶ 61,091 (2007). 20 Order No. 710 at P 16. 11. We also deem unnecessary and burdensome AGA's request that pipelines provide information regarding the amount of fuel that a pipeline has waived, discounted or reduced as part of a negotiated rate agreement. AGA argues that some pipelines currently provide information in periodic fuel reports regarding fuel that has been waived, discounted, or reduced as part of a negotiated rate agreement. In support, AGA cites a fuel report filed by Dominion Transmission, Inc. (Dominion Transmission). 21 The report cited by AGA is a 20-page annual fuel report filed by Dominion Transmission pursuant to a rate settlement agreement, and exceeds, in significant detail, the type of financial and rate information the Commission deems appropriate for Forms 2, 2-A and 3-Q. It is unlikely that all pipelines would have this information readily available since many pipelines do not periodically file to adjust fuel rates and may not keep records of this type of information. Further, it is not apparent that the level of fuel associated with these types of transactions is significant enough to warrant additional reporting requirements. Customers of pipelines that use fuel tracking mechanisms and file periodic true-up reports may explore these issues in the context of the pipeline's periodic fuel filings. For these reasons, we deny AGA's request for rehearing. 21 *See* AGA Request for Rehearing at 3, citing *Dominion Transmission, Inc.* , Docket No. RP00-632-023. C. Reinstatement of Periodic Rate Filing Requirement 12. The KCC's request for rehearing argues that the Final Rule did not address its proposal to reinstate a periodic rate-refiling requirement as a condition to issuance of a blanket certificate for open access transportation service under Part 284 of the Commission's regulations. 22 The KCC states that the Commission has the ability to impose conditions under section 7(c) of the Natural Gas Act
(NGA)and that conditioning blanket certificate authority on periodic filing of general section 4 rate cases would be within the Commission's authority. 23 Further, the KCC argues that imposing such a condition would not violate the distinction between sections 4 and 5 of the NGA any more than when the Commission imposed a triennial rate filing requirement as a condition to receipt of a purchased gas adjustment
(PGA)clause in pipeline tariffs. 24 22 KCC Request for Rehearing at 8. 23 *Id* . 24 *Id* . 25 *See* Order No. 710 at P 12. 26 *Public Service Commission of New York* v. *FERC* , 866 F.2d 487, 489 (D.C. Cir. 1989) ( *PSNY* v. *FERC* ); *see also United Distribution Companies* v. *FERC* , 88 F.3d 1105 (D.C. Cir. 1996). 13. Contrary to KCC's claim, the Final Rule addressed its request that the Commission reinstate a periodic rate-refiling requirement. 25 It is well settled that the Commission may not compromise the limits of section 5 of the NGA on the Commission's power to revise rates. 26 The KCC's proposal is inconsistent with that limitation on the Commission's powers. In *PSCNY* v. *FERC* , the court reviewed the Commission's orders in a pipeline's first NGA section 4 rate case after it had received a certificate of public convenience and necessity pursuant to section 7 of the NGA. In those orders, the Commission approved the pipeline's proposed rates. However, because the pipeline's rate base was expected to continue declining, the Commission required that the pipeline file a new section 4 rate case every three years so as to minimize the possibility of the pipeline recovering an excessive return on equity. 27 The court rejected the Commission's decision and held that the Commission's action would destroy the balance struck by the NGA in sections 4 and 5 of the act. 28 The court further admonished the Commission that it had considered earlier efforts by the Commission to “escape the inconveniences of § 5,” citing *Panhandle Eastern Pipe Line Co.* v. *FERC* , 613 F.2d 1120 (D.C. Cir. 1979) ( *Panhandle* ). In *Panhandle* , the Commission had issued a section 7 certificate and conditioned the certificate on the pipeline's crediting revenues from the new service to customers of other pipeline services. The court labeled the condition as “a de facto reduction in existing rates,” and concluded that “in light of the distinctions between §§ 4 and 5, FERC's proposed tinkering with existing rates would ‘effectively emasculate the role of section 5 in the ratemaking scheme’.” 29 27 *PSNY* v. *FERC* , 866 F.2d at 490. 28 *Id* . 29 *PSCNY* v. *FERC* , 866 F.2d at 490. *See also Northern Natural Gas Co.* v. *FERC* , 780 F.2d 59 (D.C. Cir. 1985). 14. Along the same lines, in *United Distribution Companies* v. *FERC* , the court affirmed the Commission's refusal in Order No. 636 to impose a three-year rate review on open access pipelines with blanket certificates. 30 The court rejected the claim of those in favor of retaining triennial rate review that the market-based sales authority granted to pipelines in Order No. 636 and Straight Fixed Variable
(SFV)transportation rate design required by that order are benefits to which a periodic rate filing requirement may be attached. 31 The court pointed out that pipelines were leaving the sales business, and “whatever the benefits of SFV rate design to pipelines, they are not benefits voluntarily accepted by the pipelines and so cannot be the basis for imposition of periodic rate review.” 32 The court also cited the decision in *PSCNY* v. *FERC* “noting that FERC's authority to impose a periodic rate review in the PGA context ‘obviously rests on pipeline consent’ to triennial rate review in exchange for automatic PGA adjustment authority.” 33 30 *United Distribution Cos.* v. *FERC* , 88 F.3d 110, 1175-6. 31 *Id* . at 1176. 32 *Id* . at 1176. 33 *Id* . at 1176, citing *PSCNY* v. *FERC* , 866 F.2d at 492. 15. The relief requested by KCC in this proceeding is the same and must be rejected for the same reasons. As the court has pointed out, the rate refiling requirement that was once imposed in exchange for the pipeline's ability to recover purchased gas costs through a tracker was based upon the voluntary acceptance by the pipeline of a rate refiling condition. In addition, allowing pipelines to track gas costs through a PGA was an exception to the Commission's general ratemaking policy that pipelines may not change individual components of their cost of service without filing a general section 4 rate case. Therefore, if a pipeline chose not to accept the option of PGA recovery of gas costs, its alternative was to adjust its rates for changes in its gas costs in a general section 4 rate case. Because that alternative was consistent with the Commission's general ratemaking policy, it was as consistent with the public interest as the PGA recovery option. KCC's proposal is dissimilar in both respects. In today's natural gas market, open access transportation is so fundamental to the manner in which pipelines conduct business that there is no realistic option for a pipeline not to retain its blanket certificate. The alternative would require a return to the pre-open access past when pipelines provided only individually certificated service requiring abandonment proceedings under section 7 of the NGA and would deprive the pipeline's customers and the public at large of the many benefits of open access transportation service. It is unlikely that a pipeline would “voluntarily” consent to such a condition and, in any event, the pipeline's alternative of discontinuing open access transportation service would not be in the public interest. 16. The revisions to Form Nos. 2, 2-A and 3-Q adopted in the Final Rule were designed to provide a level of information that would enhance the ability of the Commission and pipeline customers to assess the justness and reasonableness of pipeline rates. As we stated in the Final Rule, the Commission cannot compel a pipeline to file a rate case under section 4, nor can it preclude it from filing under section 4 for any reason. 34 The Commission's efforts in this regard reflect its awareness that pipeline customers need additional information to make a reasonable assessment of a pipeline's cost of service, and we believe that the Final Rule accomplishes that goal. Accordingly, we deny the KCC's request for rehearing. 34 Order No. 710 at P 12. D. Miscellaneous 17. Following the issuance of the Final Rule, staff discovered a few inadvertent errors in two of the revised schedules, pages 278 and 299. These revisions are for purposes of clarification and do not affect the level of information requested in the forms. 18. Column
(a)on page 278 is revised to reference liabilities rather than assets. The column labeled “Written off During Quarter/Year Account Charged” replaces the word “charged” with “credited.” The column labeled “Debits” is revised to read “Credits.” 19. The instructions to page 299, Monthly Quantity & Revenue Data by Rate Schedule are revised as reflected on the attached schedule. The Commission Orders The requests for clarification and/or rehearing are granted in part and denied in part as discussed in the body of this order. By the Commission. Commissioner Wellinghoff dissenting in part with a separate statement attached. Kimberly D. Bose, Secretary. BILLING CODE 6717-01-P ER27JN08.000 ER27JN08.001 ER27JN08.002 BILLING CODE 6717-01-C WELLINGHOFF, Commissioner, *dissenting in part:* On rehearing, the American Gas Association
(AGA)continues to recommend that the Commission require pipelines to provide shipper-supplied gas information reported on Sheets 521a/b by function and to include, by function, the amount of fuel that has been waived, discounted or reduced as part of a negotiated rate agreement. The Commission rejects AGA's proposals. I disagree. In denying the request for shipper-supplied gas information reported on Sheets 521a/b by function, the majority acknowledges that the detail sought by AGA would bring additional clarity to fuel costs. However, the majority states that the additional information is not needed to assess the justness and reasonableness of the pipeline's rates. The majority further states that the additional reporting would be too burdensome. The Commission recognizes that shipper-supplied gas information is critical to the clarity and transparency needed to support a reasonable analysis of fuel gas costs. 35 Sheets 521a/b operate in tandem with Sheet 520. Sheet 520 provides fuel gas costs by function. A shipper pays for fuel costs by function whether the fuel rate is fixed or tracked. Sheets 521a/b provide the volume and revenue from the disposition of excess shipper-supplied gas. However, unless Sheets 521a/b are broken out by function, a shipper cannot match the revenues generated by the sale of excess fuel with the functionalized costs. Thus, because the fuel rate would include both gas costs and excess gas revenues, the information sought by AGA is critical to assessing the justness and reasonableness of the pipeline's fuel rates. 35 *Revisions to Forms, Statements, and Reporting Requirements for Natural Gas Pipelines* , Order No. 710, 73 FR 19389 (Apr. 10, 2008), FERC Stats. & Regs. ¶ 31,267 (2008). In denying the request for the amount of fuel by function that has been waived, discounted or reduced as part of a negotiated rate agreement, the majority states that it is unlikely that all pipelines would have this information readily available. The majority also asserts that it is not apparent that the level of fuel associated with these types of transactions is significant enough to warrant additional reporting. With most pipeline expansions backstopped with negotiated rate contracts, I believe that the fuel associated with these types of transactions is not insignificant. Regardless of the level of fuel, the Commission has a strict policy that existing shippers must not subsidize the negotiated rate program. 36 In fact, in this proceeding, the Commission has stated that because pipelines may provide services from the same facilities using different rates—negotiated, discounted or recourse rates—it is important to know the level of services provided under each rate structure in order to protect against cross-subsidization. Therefore, fuel costs and revenues of the different types of rate structures broken down by function are critical to assessing the justness and reasonableness of a pipeline's fuel rates. 36 *See Alternative Rate Policy Statement* , 74 FERC ¶ 61,076 at 61,242 (1996), and *NorAm Gas Transmission Company* , 77 FERC ¶ 61,011 (1996). With regard to the reporting burden, the information requested by AGA is readily available. The pipeline maintains this information by function in order to change its fuel rate either in a tracking mechanism or its next section 4 rate filing, and to assure that its existing customers are not subsidizing the negotiated rate program. 37 The increased burden is related solely to inputting the data in the Form 2. I believe that the increased burden is justified by the utility of the information. 37 *See Alternative Rate Policy Statement* , 74 FERC ¶ 61,076 at 61,241 (1996). *For these reasons, I respectfully dissent in part from today's order.* Jon Wellinghoff, Commissioner. [FR Doc. E8-14463 Filed 6-26-08; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Parts 1 and 602 [TD 9404] RIN 1545-BE97 Capital Costs Incurred To Comply With EPA Sulfur Regulations AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Temporary regulations. SUMMARY: This document contains temporary regulations relating to the deduction provided under section 179B of the Internal Revenue Code
(Code)for qualified capital costs paid or incurred by a small business refiner to comply with the highway diesel fuel sulfur control requirements of the Environmental Protection Agency (EPA). The regulations implement changes to the law made by the American Jobs Creation Act of 2004, the Energy Policy Act of 2005, and the Tax Technical Corrections Act of 2007. The text of these temporary regulations also serves as the text of the proposed regulations set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the **Federal Register** . DATES: *Effective Date:* These regulations are effective on June 27, 2008. *Applicability Date:* For dates of applicability, see § 1.179B-1T(f). FOR FURTHER INFORMATION CONTACT: Nicole Cimino,
(202)622-3110 (not a toll-free number). SUPPLEMENTARY INFORMATION: Paperwork Reduction Act These temporary regulations are being issued without prior notice and public procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553). For this reason, the collection of information contained in these regulations has been reviewed and pending receipt and evaluation of public comments, approved by the Office of Management and Budget under control number 1545-2104. Responses to this collection of information are required to obtain a tax benefit. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number. For further information concerning this collection of information, and where to submit comments on the collection of information and the accuracy of the estimated burden, and suggestions for reducing this burden, please refer to the preamble to the cross-referencing notice of proposed rulemaking published in the Proposed Rules section in this issue of the **Federal Register** . Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. Background This document contains amendments to 26 CFR part 1 providing temporary regulations under section 179B of the Code. Section 179B was added to the Code by section 338(a) of the American Jobs Creation Act of 2004, Public Law 108-357 (118 Stat. 1418), and was modified by section 1324(a) of the Energy Policy Act of 2005, Public Law 109-58 (119 Stat. 594), and the Tax Technical Corrections Act of 2007, Public Law 110-172 (121 Stat. 2473). In general, the cost of property used in a trade or business or held for the production of income must be capitalized and, in the case of depreciable property, recovered through depreciation. Section 167 allows as a depreciation deduction a reasonable allowance for the exhaustion, wear, and tear of property used in a trade or business or held for the production of income. The depreciation allowable for tangible, depreciable property placed in service after 1986 generally is determined under section 168. In lieu of deducting depreciation, section 179B(a) allows a small business refiner to deduct as an expense 75 percent of the qualified costs as defined in section 45H(c)(2) that are paid or incurred during the taxable year and are properly chargeable to capital account (“qualified capital cost”). Section 45H(c)(2) defines qualified costs as those costs paid or incurred during the applicable period to comply with the highway diesel fuel sulfur control requirements of the EPA (the “applicable EPA regulations”). The deduction is phased out for refiners whose production in calendar year 2002 exceeded a specified threshold. Section 179B applies to expenses paid or incurred after December 31, 2002, in taxable years ending after December 31, 2002. In addition, section 45H allows a production credit of five cents per gallon for low sulfur diesel fuel produced by a small business refiner. The aggregate credit claimed by a small business refiner for all taxable years may not exceed 25 percent of the qualified costs paid or incurred by the small business refiner. The aggregate allowable credit is also phased out for refiners whose production in calendar year 2002 exceeded a specified threshold. The credit is not allowed unless Treasury certifies, after consultation with EPA, that the refiner's qualified costs will result in compliance with the applicable EPA regulations. Section 280C(d) provides for the reduction, by the amount of the credit determined under section 45H(a) for the taxable year, in deductions otherwise allowable for the taxable year under subtitle A, Chapter 1 of the Internal Revenue Code (sections 1 through 1400T). Section 45H applies to expenses paid or incurred after December 31, 2002, in taxable years ending after December 31, 2002. Section 45H(c) provides definitions of terms for purposes of both the section 179B deduction and the section 45H credit. Under section 45H(c)(1), a taxpayer is a small business refiner for a taxable year if
(i)the taxpayer is a refiner of crude oil with respect to which not more than 1,500 individuals are engaged in the refinery operations of the business on any day during the taxable year, and
(ii)the taxpayer's average daily domestic refinery run or average retained production for all facilities of the taxpayer for the 1-year period ending on December 31, 2002, did not exceed 205,000 barrels. Under section 45H(c)(2), the qualified costs with respect to any facility of a small business refiner are, in general, costs that are paid or incurred by the small business refiner to comply with the applicable EPA regulations with respect to the facility during the period beginning on January 1, 2003, and ending on the earlier of the date that is one year after the date on which the small business refiner must comply with the applicable EPA regulations for that facility, or December 31, 2009. The applicable EPA regulations are the regulations establishing the highway diesel fuel sulfur control program and apply to, among others, petroleum refiners that produce diesel fuel for heavy-duty highway vehicles. The regulations provide that these vehicles for the 2007 and later model years must be fueled with highway diesel fuel that meets a maximum sulfur standard of 15 parts per million (ppm). The regulations also require refiners to produce this new low sulfur diesel fuel beginning on June 1, 2006, but include several transition rules under which refiners are given additional time to comply with the 15 ppm sulfur standard (for example, the small refiner credit option for a refiner that is granted small refiner status by the EPA). Explanation of Provisions Scope The temporary regulations provide rules prescribing how a small business refiner must determine the deduction allowable under section 179B(a) for any taxable year. The regulations also provide guidance for making the elections under section 179B. Computation of Deduction Allowable Under Section 179B The deduction under section 179B is allowable with respect to the qualified capital costs paid or incurred by a small business refiner during the taxable year. The temporary regulations make it clear that the deduction is allowable with respect to costs paid or incurred during a taxable year even if the property to which the costs relate is not placed in service until a subsequent taxable year. The temporary regulations also make it clear that the deduction is allowable even if the small business refiner is not eligible for the credit under section 45H because of a failure to obtain the certification required by section 45H(e). Elections Section 179B provides two elections. The first election is provided under section 179B(a), which allows a small business refiner to elect to deduct an amount equal to 75 percent of the qualified capital costs paid or incurred by the small business refiner during the taxable year. These temporary regulations provide that this election is made for each taxable year in which the taxpayer seeks to deduct qualified capital costs under section 179B. The election for a taxable year applies to all qualified capital costs paid or incurred by the small business refiner during the taxable year. The election for a taxable year must be made by the due date (including extensions) for filing the small business refiner's Federal income tax return for the taxable year. The second election is provided under section 179B(e). Section 179B(e) provides that if a small business refiner is a cooperative and makes an election under section 179B(a), the small business refiner may elect to allocate part or all of the deduction allowable under section 179B(a) for the taxable year to its owners that are themselves cooperatives. If a cooperative small business refiner makes the section 179B(e) election, the temporary regulations provide that the deduction amount allocated to an owner is equal to the owner's ratable share of the total deduction amount allocated, determined on the basis of ownership interests in the cooperative small business refiner. The temporary regulations provide that in cases in which ownership interests vary during the year, the small business refiner must determine ratable shares under a consistently applied method that reasonably takes into account the varying interests during the taxable year. Further, the temporary regulations clarify that, in computing its taxable income under section 1382, the cooperative small business refiner must reduce its section 179B deduction by the deduction amount allocated to its owners. The section 179B(e) election for a taxable year is made by the due date (including extensions) for filing the cooperative small business refiner's Federal income tax return for the taxable year. In addition, section 179B(e)(3) requires the electing cooperative small business refiner to notify, in writing, each cooperative owner of the amount of the section 179B(a) deduction that is allocated to that cooperative owner. This written notice must be mailed to the cooperative owner before the due date (including extensions) of the cooperative small business refiner's Federal income tax return. Effective/Applicability Date These temporary regulations apply to taxable years ending on or after *June 26, 2008* . However, a taxpayer may apply the temporary regulations to taxable years ending after December 31, 2002, and before *June 26, 2008* provided that the taxpayer applies all provisions in these regulations (other than those relating to elections) to the taxable year. A taxpayer applying the regulations to those years may make the election under section 179B(a) for such years under the rules provided in Notice 2006-47 (2006-20 IRB 892). In addition, the taxpayer's election under section 179B(e) for those years will be accepted if made using any reasonable method consistent with the principles of section 179B(e). See § 601.601(d)(2)(ii)( *b* ) of this chapter. Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6), please refer to the Special Analyses section of the preamble to the cross-reference notice of proposed rulemaking published in the Proposed Rules section in this issue of the **Federal Register** . Pursuant to section 7805(f) of the Code, these regulations have been submitted to the Chief Counsel for Advocacy of Small Business Administration for comment on their impact on small business. Drafting Information The principal author of these regulations is Nicole R. Cimino, Office of Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and the Treasury Department participated in their development. List of Subjects 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. 26 CFR Part 602 Reporting and recordkeeping requirements. Amendments to the Regulations Accordingly, 26 CFR parts 1 and 602 are amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.179B-1T is added to read as follows: § 1.179B-1T Deduction for capital costs incurred in complying with Environmental Protection Agency sulfur regulations (temporary).
(a)*Scope and definitions* —(1) *Scope* . This section provides the rules for determining the amount of the deduction allowable under section 179B(a) for qualified capital costs paid or incurred by a small business refiner to comply with the highway diesel fuel sulfur control requirements of the Environmental Protection Agency (EPA). This section also provides rules for making elections under section 179B.
(2)*Definitions* . For purposes of section 179B and this section, the following definitions apply:
(i)The *applicable EPA regulations* are the EPA regulations establishing the highway diesel fuel sulfur control program (40 CFR part 80, subpart I).
(ii)The *average daily domestic refinery run* for a refinery is the lesser of—
(A)The total amount of crude oil input (in barrels) to the refinery's domestic processing units during the 1-year period ending on December 31, 2002, divided by 365; or
(B)The total amount of refined petroleum product (in barrels) produced by the refinery's domestic processing units during such 1-year period divided by 365.
(iii)The *aggregate average domestic daily refinery run* for a refiner is the sum of the average daily domestic refinery runs for all refineries that were owned by the refiner or a related person on April 1, 2003.
(iv)*Cooperative owner* is a person that—
(A)Directly holds an ownership interest in a cooperative small business refiner, as defined in paragraph (a)(2)(v) of this section; and
(B)Is a cooperative to which part 1 of subchapter T of the Internal Revenue Code
(Code)applies.
(v)*Cooperative small business refiner* is a small business refiner that is a cooperative to which part 1 of subchapter T of the Code applies.
(vi)*Low sulfur diesel fuel* has the meaning prescribed in section 45H(c)(5).
(vii)*Qualified capital costs* are qualified costs as defined in section 45H(c)(2) that are properly chargeable to capital account.
(viii)*Related person* has the meaning prescribed in section 613A(d)(3) and the regulations under section 613A(d)(3).
(ix)*Small business refiner* has the meaning prescribed in section 45H(c)(1).
(b)*Section 179B deduction* —(1) *In general* . Section 179B(a) allows a deduction with respect to the qualified capital costs paid or incurred by a small business refiner (the section 179B deduction). The deduction is allowable with respect to the qualified capital costs paid or incurred during a taxable year only if the small business refiner makes an election under paragraph
(d)of this section for the taxable year. The certification requirement in section 45H(e) (relating to the certification required to support a credit under section 45H) does not apply for purposes of the section 179B deduction. Accordingly, the section 179B deduction is allowable with respect to the qualified capital costs of an electing small business refiner even if the refiner never obtains a certification under section 45H(e) with respect to those costs.
(2)*Computation of section 179B deduction* —(i) *In general* . Except as provided in paragraphs (b)(2)(ii) and (c)(3) of this section, a small business refiner that makes an election under paragraph
(d)of this section for a taxable year is allowed a section 179B deduction in an amount equal to 75 percent of qualified capital costs that are paid or incurred by the small business refiner during the taxable year.
(ii)*Reduced percentage* . A small business refiner's section 179B deduction is reduced if the refiner's aggregate average daily domestic refinery run is in excess of 155,000 barrels. In that case, the number of percentage points used in computing the deduction under paragraph (b)(2)(i) of this section
(75)is reduced (not below zero) by the product of 75 and the ratio of the excess barrels to 50,000 barrels.
(3)*Example* . The application of this paragraph
(b)is illustrated by the following example: Example.
(i)A, an accrual method taxpayer, is a small business refiner with a taxable year ending December 31. On April 1, 2003, A owns a refinery with an average daily domestic refinery run (that is, an average daily run during calendar year 2002) of 100,000 barrels and a person related to A owns a refinery with an average daily domestic refinery run of 85,000 barrels. These are the only domestic refineries owned by A and persons related to A. A's aggregate average daily domestic refinery run for the two refineries is 185,000 barrels. A incurs qualified capital costs of $10 million in the taxable year ended December 31, 2007. The costs are incurred with respect to property that is placed in service in year 2008. A makes the election under paragraph
(d)of this section for the 2007 taxable year.
(ii)Because A's aggregate average daily domestic refinery run is 185,000 barrels, the percentage of the qualified capital costs that is deductible under section 179B(a) is reduced from 75 percent to 30 percent (75 percent reduced by 75 percent multiplied by 0.6 ((185,000 barrels minus 155,000 barrels)/50,000 barrels)). Thus, for 2007, A's deduction under section 179B(a) is $3,000,000 ($10,000,000 qualified capital costs multiplied by .30).
(c)*Effect on basis* —(1) *In general* . If qualified capital costs are included in the basis of property, the basis of the property is reduced by the amount of the section 179B deduction allowed with respect to such costs.
(2)*Treatment as depreciation* . If qualified capital costs are included in the basis of depreciable property, the amount of the section 179B deduction allowed with respect to such costs is treated as a depreciation deduction for purposes of section 1245.
(d)*Election to deduct qualified capital costs* —(1) *In general* —(i) *Section 179B election* . This paragraph
(d)prescribes rules for the election to deduct the qualified capital costs paid or incurred by a small business refiner during a taxable year (the section 179B election). A small business refiner making the section 179B election for a taxable year consents to, and agrees to apply, all of the provisions of section 179B and this section to qualified capital costs paid or incurred by the refiner during the taxable year. The section 179B election for a taxable year applies with respect to all qualified capital costs paid or incurred by the small business refiner during that taxable year.
(ii)*Year-by-year election* . A separate section 179B election must be made for each taxable year in which the taxpayer seeks to deduct qualified capital costs under section 179B. A small business refiner may make the section 179B election for some taxable years and not for other taxable years.
(iii)*Elections for cooperative small business refiners* . See paragraph
(e)of this section for the rules applicable to the election provided under section 179B(e), relating to the election to allocate the section 179B deduction to cooperative owners of a cooperative small business refiner (the section 179B(e) election).
(2)*Time and manner for making section 179B election* —(i) *Time for making election* . Except as provided in paragraph (d)(2)(iii) of this section, a taxpayer's section 179B election for a taxable year must be made by the due date (including extensions) for filing the taxpayer's Federal income tax return for the taxable year.
(ii)*Manner of making election* —(A) *In general* . Except as provided in paragraph (d)(2)(iii) of this section, the section 179B election for a taxable year is made by claiming a section 179B deduction on the taxpayer's original Federal income tax return for the taxable year and attaching the statement described in paragraph (d)(2)(ii)(B) of this section to the return. The section 179B election with respect to qualified capital costs paid or incurred by a partnership is made by the partnership and the section 179B election with respect to qualified capital costs paid or incurred by an S corporation is made by the S corporation. In the case of qualified capital costs paid or incurred by the members of a consolidated group (within the meaning of § 1.1502-1(h)), the section 179B election with respect to such costs is made for each member by the common parent of the group.
(B)*Information required in election statement* . The election statement attached to the taxpayer's return must contain the following information: ( *1* ) The name and identification number of the small business refiner. ( *2* ) The amount of the qualified capital costs paid or incurred during the taxable year for which the election is made. ( *3* ) The aggregate average daily domestic refinery run (as determined under paragraph (a)(2)(iii) of this section). ( *4* ) The date by which the small business refiner must comply with the applicable EPA regulations. If this date is not June 1, 2006, the statement also must explain why compliance is not required by June 1, 2006. ( *5* ) The calculation of the section 179B deduction for the taxable year. ( *6* ) For each property that will have its basis reduced on account of the section 179B deduction for the taxable year, a description of the property, the amount included in the basis of the property on account of qualified capital costs paid or incurred during the taxable year, and the amount of the basis reduction to that property on account of the section 179B deduction for the taxable year.
(iii)Except as otherwise expressly provided by the Code, the regulations under the Code, or other guidance published in the Internal Revenue Bulletin, a section 179B election is valid only if made at the time and in the manner prescribed in this paragraph (d)(2). For example, except as otherwise expressly provided, the 179B election cannot be made for a taxable year to which this section applies through a request under section 446(e) to change the taxpayer's method of accounting.
(3)*Revocation of election* . An election made under this paragraph
(d)may not be revoked without the prior written consent of the Commissioner of Internal Revenue. To seek the Commissioner's consent, the taxpayer must submit a request for a private letter ruling (for further guidance, see, for example, Rev. Proc. 2008-1 (2008-1 IRB 1) and § 601.601(d)(2)(ii)( *b* ) of this chapter).
(4)*Failure to make election* . If a small business refiner does not make the section 179B election for a taxable year at the time and in the manner prescribed in paragraph (d)(2) of this section, no deduction is allowed for the qualified capital costs that the refiner paid or incurred during the year. Instead these qualified capital costs are chargeable to a capital account in that taxable year, the basis of the property to which these costs are capitalized is not reduced on account of section 179B, and the amount of depreciation allowable for the property attributable to these costs is determined by reference to these costs unreduced by section 179B.
(5)*Elections for taxable years ending before June 26, 2008* . This section does not apply to section 179B elections for taxable years ending before June 26, 2008. The rules for making the section 179B election for a taxable year ending before June 26, 2008 are provided in Notice 2006-47 (2006-20 IRB 892). See § 601.601(d)(2)(ii)( *b* ) of this chapter.
(e)*Election under section 179B(e) to allocate section 179B deduction to cooperative owners* —(1) *In general* . A cooperative small business refiner may elect to allocate part or all of its cooperative owners' ratable shares of the section 179B deduction for a taxable year to the cooperative owners (the section 179B(e) election). The section 179B deduction allocated to a cooperative owner is equal to the cooperative owner's ratable share of the total section 179B deduction allocated. A cooperative owner's ratable share is determined for this purpose on the basis of the cooperative owner's ownership interest in the cooperative small business refiner during the cooperative small business refiner's taxable year. If the cooperative owners' interests vary during the year, the cooperative small business refiner shall determine the owners' ratable shares under a consistently applied method that reasonably takes into account the owners' varying interests during the taxable year.
(2)*Cooperative small business refiner denied section 1382 deduction for allocated portion* . In computing taxable income under section 1382, a cooperative small business refiner must reduce its section 179B deduction for the taxable year by an amount equal to the section 179B deduction allocated under this paragraph
(e)to the refiner's cooperative owners for the taxable year.
(3)*Time and manner for making election* —(i) *Time for making election* . The section 179B(e) election for a taxable year must be made by the due date (including extensions) for filing the cooperative small business refiner's Federal income tax return for the taxable year.
(ii)*Manner of making election* . The section 179B(e) election for a taxable year is made by attaching a statement to the cooperative small business refiner's Federal income tax return for the taxable year. The election statement must contain the following information:
(A)The name and identification number of the cooperative small business refiner.
(B)The amount of the section 179B deduction allowable to the cooperative small business refiner for the taxable year (determined before the application of section 179B(e) and this paragraph (e)).
(C)The name and identification number of each cooperative owner to which the cooperative small business refiner is allocating all or some of the section 179B deduction.
(D)The amount of the section 179B deduction that is allocated to each cooperative owner listed in response to paragraph (e)(3)(ii)(C) of this section.
(4)*Irrevocable election* . A section 179B(e) election for a taxable year, once made, is irrevocable for that taxable year.
(5)*Written notice to owners* . A cooperative small business refiner that makes a section 179B(e) election for a taxable year must notify each cooperative owner of the amount of the section 179B deduction that is allocated to that cooperative owner. This notification must be provided in a written notice that is mailed by the cooperative small business refiner to its cooperative owner before the due date (including extensions) of the cooperative small business refiner's Federal income tax return for the election year. In addition, the cooperative small business refiner must report the amount of the cooperative owner's section 179B deduction on Form 1099-PATR, “Taxable Distributions Received From Cooperatives,” issued to the cooperative owner. If Form 1099-PATR is revised or renumbered, the amount of the cooperative owner's section 179B deduction must be reported on the revised or renumbered form.
(f)*Effective/applicability date* —(1) *In general* . This section applies to taxable years ending on or after June 26, 2008.
(2)*Application to taxable years ending before June 26, 2008* . A small business refiner may apply this section to a taxable year ending before June 26, 2008, provided that the small business refiner applies all provisions in this section, with the modifications described in paragraph (f)(3) of this section, to the taxable year.
(3)*Modifications applicable to taxable years ending before June 26, 2008* . The following modifications to the rules of this section apply to a small business refiner that applies those rules to a taxable year ending before *June 26, 2008* :
(i)*Rules relating to section 179B election* . The section 179B election for a taxable year ending before *June 26, 2008* may be made under the rules provided in Notice 2006-47, rather than under the rules set forth in paragraph
(d)of this section.
(ii)*Rules relating to section 179B(e) election* . A section 179B(e) election for a taxable year ending before *June 26, 2008* will be treated as satisfying the requirements of paragraph
(f)if the cooperative small business refiner has calculated its tax liability in a manner consistent with the election and has used any reasonable method consistent with the principles of section 179B(e) to inform the Internal Revenue Service that an election has been made under section 179B(e) and to inform cooperative owners of the amount of the section 179B deduction they have been allocated.
(4)*Expiration date* . The applicability of § 179B-1T expires on *June 24, 2011* . PART 602—OMB CONTROL NUMBERS UNDER THE PAPERWORK REDUCTION ACT **Par. 3.** The authority citation for part 602 continues to read as follows: Authority: 26 U.S.C. 7805 * * * **Par. 4.** In § 602.101, paragraph
(b)is amended by adding the following entry in numerical order to the table to read as follows: § 602.101 OMB Control numbers.
(b)* * * CFR part or section where identified and described Current OMB control No. * * * * * 1.179B-1T 1545-2076 * * * * * Kevin M. Brown, Deputy Commissioner for Services and Enforcement. Approved: June 15, 2007. Eric Solomon, Assistant Secretary of the Treasury (Tax Policy). [Editorial Note: This document was *received* at the **Federal Register** on June 23, 2008.] [FR Doc. E8-14556 Filed 6-26-08; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2008-0096] RIN 1625-AA00 Safety Zone; Festival of Sail 2008 Ship's Parade; San Diego Harbor, San Diego, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone, on the navigable waters of San Diego Bay in support of the Festival of Sail 2008 Ship's Parade. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, participating vessels, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative. DATES: This rule is effective from 10 a.m. until 1 p.m. on August 20, 2008. ADDRESSES: Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2008-0096 and are available online at * http:// www.regulations.gov. * This material is also available for inspection or copying at two locations: the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays and the U.S. Coast Guard Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101 between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary rule, call Petty Officer Kristen Beer, USCG, Waterways Management, U.S. Coast Guard Sector San Diego at
(619)278-7233. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Regulatory Information On April 23, 2008, we published a notice of proposed rulemaking
(NPRM)entitled Safety Zone; Festival of Sail 2008 Ship's Parade; San Diego Harbor, San Diego, CA in the **Federal Register** (73 FR 21880). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose The Maritime Museum of San Diego is sponsoring the Festival of Sail 2008 Ship's Parade, which will transit through San Diego Bay. The event is a classic naval review consisting of 15 tall ships of various classes, some of which are restricted in their maneuverability. The sponsor will provide 16 enforcement vessels to patrol this event. This temporary safety zone is necessary to provide for the safety of the participants, crew, spectators, sponsor vessels, and other users of the waterway. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders. Regulatory Planning and Review 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 proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. This determination is based on the size and location of the safety zone. Commercial vessels will not be hindered by the safety zone. Recreational vessels will not be allowed to transit through the designated safety zone during the specified times. 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 will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the San Diego Bay from 10 a.m. to 1 p.m. on August 20, 2008. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for only three hours for a period of one day. Vessel traffic can pass safely around the safety zone. Before the effective period, the Coast Guard will publish a local notice to mariners
(LNM)and will issue broadcast notice to mariners
(BNM)alerts via marine channel 16 VHF before the safety zone is enforced. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM 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. 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, under the Instruction, 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)(g), of the Instruction, from further environmental documentation. A final environmental analysis checklist and a final categorical exclusion determination are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, and Waterways. Words of Issuance and Proposed Regulatory Text For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. A new temporary § 165.T11-014 to read as follows: § 165.T11-014 Safety Zone; Festival of Sail 2008 Ship's Parade; San Diego Harbor, San Diego, CA.
(a)*Location.* The limits of the moving safety zone are as follows: The route would start at 32°37.15′ N, 117°14.07′ W and would proceed northeast between green Buoy #3 and red Buoy #4 at 32°38.12′ N, 117°13.74′ W, then north between green Buoy #5 and red Buoy #6 at 32°39.14′ N, 117°13.51′ W, then north through the harbor channel to 32°42.07′ N, 117°13.90′ W, and then northeast to 32°43.11′ N, 117°12.71′ W, and then east to 32°43.13′ N, 117°11.12′ W, and finally southeast to the Coronado Bridge at 32°41.45′ N, 117°09.18′ W. The safety zone will encompass 1000 yards forward, 200 yards each side, and 500 yard aft of each vessel participating in the parade.
(b)*Enforcement Period.* This section will be enforced from 10 a.m. to 1 p.m. on August 20, 2008. If the event concludes prior to the scheduled termination time, the Captain of the Port will cease enforcement of this safety zone and will announce that fact via Broadcast Notice to Mariners.
(c)*Definitions.* The following definition applies to this section: *designated representative* , means any commissioned, warrant, and petty officers of the Coast Guard on board Coast Guard, Coast Guard Auxiliary, and local, state, and federal law enforcement vessels who have been authorized to act on the behalf of the Captain of the Port.
(d)*Regulations.*
(1)In accordance with the general regulations in § 165.23 of this part, entry into, transit through, or anchoring within this zone by all vessels is prohibited, unless authorized by the Captain of the Port, or his designated representative.
(2)Mariners requesting permission to transit through the safety zone may request authorization to do so from the Patrol Commander. The Patrol Commander may be contacted via VHF-FM channel 16.
(3)All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated representative.
(4)Upon being hailed by U.S. Coast Guard patrol personnel by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed.
(5)The Coast Guard may be assisted by other federal, state, or local agencies. Dated: June 10, 2008. C. V. Strangfeld, Captain, U.S. Coast Guard, Captain of the Port San Diego. [FR Doc. E8-14512 Filed 6-26-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2008-0180] RIN 1625-AA00 Safety Zone; Patapsco River, Northwest and Inner Harbors, Baltimore, MD AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone upon certain waters of the Patapsco River, Northwest Harbor and Inner Harbor during the movements of the historic sloop-of-war USS CONSTELLATION. This action is necessary to provide for the safety of life on navigable waters during two tows of the vessel in Baltimore, Maryland; one from its berth at Baltimore's Inner Harbor to a berth at the South Locust Point Marine Terminal, and the other from the South Locust Point Marine Terminal to its berth at Baltimore's Inner Harbor. This action will restrict vessel traffic in portions of the Patapsco River, Northwest Harbor, and Inner Harbor during these events. DATES: This rule is effective from 5 p.m. on August 8, 2008 through 11 a.m. on August 10, 2008. ADDRESSES: Comments and material received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2008-0180 and are available online at *http://www.regulations.gov.* This material is also available for inspection or copying at two locations: The Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays and the Commander, U.S. Coast Guard Sector Baltimore, 2401 Hawkins Point Road, Building 70, Waterways Management Division, Baltimore, Maryland 21226-1791 between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary rule, call Mr. Ronald Houck, at Coast Guard Sector Baltimore, Waterways Management Division, at telephone number
(410)576-2674 or
(410)576-2693. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Regulatory Information On April 15, 2008, we published a notice of proposed rulemaking
(NPRM)entitled “Safety Zone; Patapsco River, Northwest and Inner Harbors, Baltimore, MD” in the **Federal Register** (73 FR 20220). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose The USS CONSTELLATION Museum is planning to conduct a ceremony in the Port of Baltimore, Maryland, involving the sloop-of-war USS CONSTELLATION on Friday, August 8, 2008. Scheduled events include a four-hour tow of the USS CONSTELLATION beginning at 6 p.m., from its berth at Pier 1 Inner Harbor to the Locust Point Cruise Ship Terminal berth at the South Locust Point Marine Terminal, with an onboard salute with navy pattern cannon while the historic vessel is positioned off Fort McHenry National Monument and Historic Site. A one-hour return tow of the CONSTELLATION is scheduled for Sunday, August 10, 2008. Departure from the Locust Point Cruise Ship Terminal will occur at 7 a.m. and arrival at Pier 1 Inner Harbor at 8 a.m. For both tows, the historic Sloop-of-War USS CONSTELLATION will be towed “dead ship,” which means that the vessel will be underway without the benefit of mechanical or sail propulsion. While berthed at the Locust Point Cruise Ship Terminal, the vessel will participate in the commissioning ceremonies for the U.S. Navy's new Arleigh Burke class Aegis guided missile destroyer USS STERETT, DDG 104. The Coast Guard anticipates a large recreational boating fleet during these events, scheduled on a weekend during the summer in Baltimore, Maryland. Operators should expect significant vessel congestion along the planned route. The purpose of this rule is to promote maritime safety and protect participants and the boating public in the Port of Baltimore immediately prior to, during, and after the scheduled event. The rule will provide for a clear transit route for the participating vessels, and provide a safety buffer around the participating vessels while they are in transit. The rule will impact the movement of all vessels operating upon certain waters of the Patapsco River, Northwest Harbor and Inner Harbor. Discussion of Comments and Changes The Coast Guard received no comments in response to the NPRM. No public meeting was requested and none was held. A problem with the number of the rule (.08 versus .05) was discovered and corrected. Regulatory Analyses We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders. Regulatory Planning and Review 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. There is little vessel traffic associated with recreational boating and commercial fishing in the area during the effective period. 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 operate, remain or anchor within certain waters of the Patapsco River, Northwest Harbor and Inner Harbor, in Baltimore, Maryland, from 5 p.m. through 11 p.m. on August 8, 2008 and from 6 a.m. through 11 a.m. on August 10, 2008. Because the zone is of limited size and duration, it is expected that there will be minimal disruption to the maritime community. Before the effective period, the Coast Guard will issue maritime advisories widely available to users of the river and harbors to allow mariners to make alternative plans for transiting the affected areas. In addition, smaller vessels not constrained by their draft, which are more likely to be small entities, may transit around the safety zone. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM 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. 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, under the Instruction, 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)(g.), of the Instruction, from further environmental documentation. This rule establishes a safety zone. A final environmental analysis checklist and a final categorical exclusion determination will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, and Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T05-019 to read as follows: § 165.T05-019 Safety Zone; Patapsco River, Northwest and Inner Harbors, Baltimore, MD.
(a)Definitions. For the purposes of this section:
(1)*Captain of the Port Baltimore, Maryland* means the Commander, Coast Guard Sector Baltimore or any Coast Guard commissioned, warrant, or petty officer who has been authorized by the Captain of the Port Baltimore, Maryland to act on his or her behalf.
(2)*USS CONSTELLATION “turn-around” participants* means the USS CONSTELLATION, its support craft and the accompanying towing vessels.
(b)Location. The following area is a moving safety zone: all waters within 200 yards ahead of, 100 yards outboard and 100 yards aft of the historic Sloop-of-War USS CONSTELLATION, surface to bottom, while operating in the Inner Harbor, the Northwest Harbor and the Patapsco River.
(c)Regulations:
(1)The general regulations governing safety zones, found in Sec. 165.23, apply to the safety zone described in paragraph
(b)of this section.
(2)With the exception of USS CONSTELLATION “turn-around” participants, entry into or remaining in this zone is prohibited, unless authorized by the Captain of the Port Baltimore, Maryland.
(3)Persons or vessels requiring entry into or passage through the moving safety zone must first request authorization from the Captain of the Port Baltimore, Maryland to seek permission to transit the area. The Captain of the Port Baltimore, Maryland can be contacted at telephone number
(410)576-2693. The Coast Guard vessels enforcing this section can be contacted on Marine Band Radio VHF Channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light, or other means, the person or vessel shall proceed as directed. If permission is granted, all persons or vessels must comply with the instructions of the Captain of the Port, Baltimore, Maryland, and proceed at the minimum speed necessary to maintain a safe course while within the zone.
(d)Enforcement. The U.S. Coast Guard may be assisted in the patrol and enforcement of the zone by Federal, State and local agencies.
(e)Effective periods. This section will be effective from 5 p.m. on August 8, 2008 and through 11 a.m. on August 10, 2008. Dated: June 12, 2008. Brian D. Kelley, Captain, U.S. Coast Guard, Captain of the Port, Baltimore, Maryland. [FR Doc. E8-14601 Filed 6-26-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2008-0490] RIN 1625-AA00 Safety Zone; Erie Summer Festival of the Arts, Presque Isle Bay, Erie, PA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on Lake Erie, Presque Isle Bay, Erie, PA. This zone is intended to restrict vessels from a portion of Presque Isle Bay during the June 28, 2008, Erie Summer Festival of the Arts fireworks event. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with fireworks displays. DATES: This rule is effective from 10 p.m. to 11 p.m. on June 28, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG-2008-0490 and are available for inspection or copying at two locations: the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and the U.S. Coast Guard Sector Buffalo, 1 Fuhrmann Boulevard, Buffalo, NY 14203 between 9:30 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this temporary rule, call Commander Joseph Boudrow, Prevention Division, U.S. Coast Guard Sector Buffalo, at 716-843-9572. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The permit application was not received in time to publish an NPRM followed by a final rule before the effective date. Under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective fewer than 30 days after publication in the **Federal Register** . Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property. Background and Purpose This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with a fireworks display. Based on accidents that have occurred in other Captain of the Port zones, and the explosive hazards of fireworks, the Captain of the Port Buffalo has determined that fireworks launches proximate to watercraft pose a significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water could easily result in serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property at these events and help minimize the associated risks. Discussion of Rule A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading and launching of a fireworks display in conjunction with the Erie Summer festival of the Arts fireworks display. The fireworks display will occur between 10 p.m. and 11 p.m. on June 28, 2008. The safety zone for the fireworks will encompass all waters of Lake Erie, Presque Isle Bay, Erie, PA, within a 420 ft radius of position 42°07′45″ N, 080°06′20″ W. All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his on-scene representative. The Captain of the Port or his on-scene representative may be contacted via VHF Channel 16. 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. This determination is based on the minimal time that vessels will be restricted from the zone and the zone is an area where the Coast Guard expects insignificant adverse impact to mariners from the zones' activation. 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 will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to transit or anchor in a portion of Lake Erie, Presque Isle Bay, Erie, PA, between 10 p.m. and 11 p.m. on June 28, 2008. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for only one hour for one event. Vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Buffalo to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect. 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. 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 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 would not result in such 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 concern an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that these regulations and fishing rights protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes that have questions concerning the provisions of this Rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT . 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 procedure; and related management system 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 which guides 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)(g), of the Instruction, from further environmental documentation. This event establishes a safety zone therefore paragraph (34)(g) of the Instruction applies. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, and Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. A new temporary § 165.T09-0490 is added as follows: § 165.T09-0490 Safety zone; Erie Summer Festival of the Arts, Lake Erie, Presque Isle Bay, Erie, PA.
(a)*Location.* The following area is a temporary safety zone: all waters of Lake Erie, Presque Isle Bay, Erie, PA, within a 420 ft radius of position (42°07′45″ N, 080°06′20″ W). (DATUM: NAD 83).
(b)*Effective period.* This regulation is effective from 10 p.m. to 11 p.m. on June 28, 2008.
(c)*Regulations.*
(1)In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port Buffalo, or his on-scene representative.
(2)This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Buffalo or his on-scene representative.
(3)The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel.
(4)Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Buffalo or his on-scene representative to obtain permission to do so. The Captain of the Port or his on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Buffalo or his on-scene representative. Dated: *June 13, 2008.* S.J. Ferguson, Captain, U.S. Coast Guard, Captain of the Port Buffalo. [FR Doc. E8-14615 Filed 6-26-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2008-0569] RIN 1625-AA87 Security Zone; Waters Adjacent 10th Avenue Marine Terminal, San Diego, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary security zone in the waters adjacent to the 10th Avenue Marine Terminal, San Diego Bay, San Diego, CA. This action is needed to protect the U.S. Naval vessels, their crews and the public during a military out load evolution from sabotage or other subversive acts, accidents, criminal actions or other causes of a similar nature. Entry, transit or anchoring in this zone is prohibited unless authorized by the Captain of the Port San Diego, or his designated representative. DATES: This rule is effective from 7 a.m. on June 25, 2008, to 7 p.m. on June 28, 2008. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of Docket No. 2008-0569 and are available for inspection or copying at Coast Guard Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101-1064 between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Chief Petty Officer Eric Carroll, Waterways Management, Coast Guard Sector San Diego, at telephone
(619)278-7268. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Based on the military function exception set forth in the Administrative Procedure Act, 5 U.S.C. 553(a)(1), notice-and-comment rulemaking and advance publication, pursuant to 5 U.S.C. 553(b) and (d), are not required for this regulation. In addition, even if an NPRM were otherwise required, under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this regulation effective less than 30 days after publication in the **Federal Register** . It would be contrary to public interest to delay the effective date of this temporary rule. Background and Purpose The U.S. Military Surface Deployment and Distribution Command notified the Coast Guard concerning military out load operations at the Port of San Diego's Tenth Avenue Marine Terminal for the dates given. This temporary security zone is needed to protect the U.S. Naval vessels and their crews for the duration of the evolution of military out load operations. Discussion of Rule The security zone generally consists of the navigable waters surrounding the 10th Avenue Marine Terminal. The limits of this security zone are more specifically defined as the area enclosed by the following points: starting on shore at 32°42′15″ N 117°09′39″ W, then extending southwesterly to 32°42′02″ N 117°09′51″ W, then southeasterly to 32°41′43″ N 117°09′25″ W, northeasterly to shore at 32°41′47″ N 117°09′20″ W and then along the shoreline to starting point. The security zone will be enforced by Coast Guard patrol craft and San Diego Harbor Police as authorized by the Captain of the Port San Diego (COTP). See 33 CFR 6.04-11, Assistance of other agencies. Persons and vessels are prohibited from entering into or transiting through this security zone unless authorized by the Captain of the Port, or his designated representative. 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. Due to National Security interests, the implementation of this security zone is necessary for the protection of the United States and its people. The size of the zone is the minimum necessary to provide adequate protection for the U.S. Naval vessels, their crews, adjoining areas and the public. Most of the entities likely to be affected are pleasure craft engaged in recreational activities and sightseeing. Any hardships experienced by persons or vessels are considered minimal compared to the national interest in protecting U.S. Naval vessels, their crews and the public. 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 will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to transit or anchor in the portion of San Diego Bay south of Harbor Island from 7 a.m. on June 25, 2008, to 7 p.m. on June 28, 2008. However, these security zones will not have a significant economic impact on a substantial number of small entities because these zones are limited in scope and duration. In addition, the Coast Guard will issue broadcast notice to mariners
(BNM)alerts via VHF-FM marine channel 16 before the security zone is enforced. 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 your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Chief Petty Officer Eric Carroll, Waterways Management, Sector San Diego at
(619)278-7268. 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). 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 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 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)(g), of the Instruction, from further environmental documentation because we are establishing a security zone. A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for Part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195, 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Section 165.T11-063 is added to read as follows: Section 165.T11-063 Security Zone; Waters Adjacent 10th Avenue Marine Terminal, San Diego, CA
(a)*Location* . The security zone consists of the navigable waters surrounding the 10th Avenue Marine Terminal. The limits of this security zone are more specifically defined as the area enclosed by the following points: Starting on shore at 32°42′15″ N 117°09′39″ W, then extending southwesterly to 32°42′02″ N 117°09′51″ W, then southeasterly to 32°41′43″ N 117°09′25″ W, northeasterly to shore at 32°41′47″ N 117°09′20″ W and then along the shoreline to starting point.
(b)*Effective period* . This section will be in effect from 7 a.m. on June 25, 2008, to 7 p.m. on June 28, 2008. If the need for the security zone ends before the scheduled termination time, the Captain of the Port San Diego will cease enforcement of this security zone and will announce that fact via Broadcast Notice to Mariners.
(c)*Regulations* . In accordance with the general regulations in § 165.33 of this part, entry into, transit through, or anchoring within the security zone described in paragraph
(a)of this section by all vessels is prohibited, unless authorized by the Captain of the Port, or his designated representative. All other general regulations of § 165.33 of this part apply in the security zone established by this section.
(d)*Enforcement* . All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene patrol personnel. Patrol personnel can be comprised of commissioned, warrant, and petty officers of the Coast Guard onboard Coast Guard, local, state, and federal law enforcement vessels. Upon being hailed by U.S. Coast Guard patrol personnel by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed. The U.S. Coast Guard may be assisted in the patrol and enforcement of this security zone by the San Diego Harbor Police. Dated: June 18, 2008. C.V. Strangfeld, Captain, U.S. Coast Guard, Captain of the Port San Diego. [FR Doc. E8-14613 Filed 6-26-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2008-0146] RIN 1625-AA00 Temporary Safety Zone; Wreckage of the M/V NEW CARISSA, Pacific Ocean 3 Nautical Miles North of the Entrance to Coos Bay, OR AGENCY: Coast Guard, DHS. ACTION: Temporary Final Rule. SUMMARY: The Coast Guard is establishing a temporary safety zone on the waters of the Pacific Ocean encompassed in the 1000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 NM north of the entrance to Coos Bay, Oregon. The Captain of the Port Portland is taking this action to safeguard individuals and vessels involved in a salvage operation involving the M/V NEW CARISSA. Entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative. DATES: This regulation is effective from 10 a.m. June 5, 2008, to 11:59 p.m. August 31, 2008, unless canceled earlier through broadcast notice to mariners. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket USCG-2008-0146 and are available online at *http://www.regulations.gov* . They are also available for inspection or copying at two locations: the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays, and Coast Guard Sector Portland, 6767 N. Basin Ave., Portland, OR 97217 between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: MST1 Lucia Mack, Waterways Management, c/o Captain of the Port Portland, 6767 N. Basin Ave, Portland, OR 97217-3992, and
(503)240-9311. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for not publishing an NPRM and for making this rule effective less than 30 days after publication in the **Federal Register** . The Coast Guard was not given a start date for this operation and just recently became aware of its progress which did not allow for prior notice. Publishing a NPRM would be contrary to public interest since immediate action is necessary to allow for the safe salvage of the wreckage of the M/V NEW CARISSA which is aground upon a sand bar in the Pacific Ocean 3 NM north of the entrance to Coos Bay, Oregon. If normal notice and comment procedures were followed, this rule would not become effective until after the date of the salvage operation. For this reason, following the normal rulemaking procedures in this case would be impracticable and contrary to the public safety. Background and Purpose The Coast Guard is establishing a temporary safety zone on the waters of the Pacific Ocean encompassed in the 1000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 NM north of the entrance to Coos Bay, Oregon. Entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative from 10 a.m. June 5, 2008, to 11:59 p.m. August 31, 2008, unless canceled earlier through broadcast notice to mariners. The Captain of the Port Portland is taking this action to safeguard individuals and vessels involved in a salvage operation involving the wreck of the M/V NEW CARISSA. This safety zone will be enforced by representatives of the Captain of the Port Portland. The Captain of the Port may be assisted by other federal, state, and local agencies. Discussion of Rule This rule, for safety concerns, will control vessels, personnel, and individual movements on the waters of the Pacific Ocean encompassed in the 1000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 NM north of the entrance to Coos Bay, Oregon as indicated in section 2 of this Temporary Final Rule. Entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative. Coast Guard Personnel and local law enforcement will enforce this safety zone. The Captain of the Port may be assisted by other federal and local agencies. 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. The Coast Guard expects the economic impact of this proposal to be so minimal the full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures unnecessary. This expectation is based on the fact that the regulated areas established by the proposed regulation will involve a small area of the Pacific Ocean along the Oregon Coast that doesn't have much vessel traffic. The removal of the wreckage of the M/V NEW CARISSA in a controlled and deliberate operation ensures the safety of future traffic in that the vessel will not be allowed to deteriorate in a fashion which could cause unknown navigation hazards and/or additional pollution in the area. The removal of the wreck's potential to create these incidents will offset any potential adverse economic impact these restrictions might have. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ), 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 will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit a small area of the Pacific Ocean along the Oregon Coast encompassed in the 1000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 NM north of the entrance to Coos Bay, Oregon. Entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The safety zone applies to a tiny portion of the Pacific Ocean, entities wishing to transit in the vicinity of this area may pass outside of the safety zone to continue their transit. We will issue a broadcast notice to mariners on the effected portion of the Pacific Ocean. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they may better evaluate its effects on them and participate in the rulemaking process. If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. 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 proposed 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 would 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 affect 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 proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might 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, under the Instruction, 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)(g), of the Instruction, from further environmental documentation because it establishes a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine Safety, Navigation (water), Reporting and Record Keeping Requirements, Security Measures, and Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. A temporary section in 165.T13-035 is added to read as follows: § 165.T13-035 Safety Zone: Wreckage of the M/V NEW CARISSA, Pacific Ocean 3 Nautical Miles North of the Entrance to Coos Bay, Oregon.
(a)Location. The following area is a safety zone: The waters of the Pacific Ocean encompassed by a 1000 yard radius surrounding the wreckage of the M/V NEW CARISSA located 3 NM north of the entrance to Coos Bay, Oregon.
(b)Enforcement period. This rule will be in effect from 10 a.m. June 05, 2008, to 11:59 p.m. August 31, 2008.
(c)Regulations. In accordance with the general regulations in § 165.23 of this part, entry into this safety zone is prohibited unless authorized by the Captain of the Port or his designated representative. Dated: June 5, 2008. F.G. Myer, Captain, U.S. Coast Guard, Captain of the Port Portland. [FR Doc. E8-14616 Filed 6-26-08; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2006-0130-200814; FRL-8684-4] Approval and Promulgation of Implementation Plans Florida; Prevention of Significant Deterioration AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is taking final action to conditionally approve revisions to the Florida State Implementation Plan
(SIP)submitted by the State of Florida on February 3, 2006. The SIP revisions modify the Florida Prevention of Significant Deterioration
(PSD)program to address changes to the federal new source review
(NSR)regulations, which were promulgated by EPA on December 31, 2002, and reconsidered with minor changes on November 7, 2003 (commonly referred to as the “2002 NSR Reform Rules”). In addition EPA is approving Florida's concurrent February 3, 2006, request to make the State's PSD permitting program applicable to electric power plants, which are also subject to the Florida Electrical Power Plant Siting Act (PPSA). EPA proposed conditional approval of these revisions on April 4, 2008; no comments were received on that proposal. DATES: *Effective Date:* This rule will be effective July 28, 2008. ADDRESSES: EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2006-0130. 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., Confidential Business Information 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 *http://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: For information regarding the Florida State Implementation Plan, contact Ms. Heidi LeSane, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number is
(404)562-9074. Ms. LeSane can also be reached via electronic mail at *lesane.heidi@epa.gov.* For information regarding New Source Review, contact Ms. Yolanda Adams, Air Permits Section, at the same address above. The telephone number is
(404)562-9214. Ms. Adams can also be reached via electronic mail at *adams.yolanda@epa.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. What action is EPA taking? II. What is the background of EPA's action on the Florida PSD rule revisions? III. What is the background of EPA's action on Florida's PSD program for electric power plants? IV. Final Action V. Statutory and Executive Order Reviews I. What action is EPA taking? NSR Reform Revisions. EPA is taking final action to conditionally approve revisions to the Florida SIP (Florida Administrative Code (F.A.C.) Chapters 62-204, 62-210, and 62-212) as submitted by the Florida Department of Environmental Protection
(FDEP)on February 3, 2006, which included changes to Florida's PSD program. As part of the current conditional approval, Florida has agreed to
(1)revise the definition of “new emissions unit” to be consistent with the federal definition or revise the definition to define what is meant by “beginning normal operation” and provide an equivalency demonstration supporting the revised definition;
(2)revise the definition of “significant emissions rate” to include ozone depleting substances;
(3)withdraw the request that EPA include a significant emissions rate for mercury in the Florida SIP, specifically F.A.C. Chapter 62-210.200(243)(a)2; and
(4)revise the recordkeeping requirements at F.A.C. section 62-212.300(3)(a)1 to be consistent with federal requirements found at 40 CFR 51.166(r)(6). Applicability of Florida's SIP-approved PSD permitting program to electric power plants. In addition to and in conjunction with the conditional approval of Florida's PSD SIP revisions, EPA is approving Florida's concurrent February 3, 2006, request to make the State's PSD permitting program applicable to electric power plants subject to the Florida PPSA. This means that Florida's SIP-approved PSD permitting program, including the conditional approval of the State's PSD revisions noted above, will apply to electric power plants in Florida in lieu of the current federally delegated PSD program. On April 4, 2008 (73 FR 18466), EPA published a notice of proposed rulemaking
(NPR)in the **Federal Register** , proposing to conditionally approve the Florida SIP revisions and proposing to approve Florida's request to make the State's PSD program applicable to electric power plants, which are also subject to the Florida PPSA. The April 4, 2008, NPR provides additional information about the proposed Florida SIP revisions and the rationale for this final action. The public comment period for the proposed action ended on May 5, 2008. No comments were received on EPA's proposed action. EPA is now taking final action to conditionally approve the February 3, 2006, SIP revision from Florida and to approve Florida's request to make the State's PSD permitting program applicable to electric power plants subject to the Florida PPSA. II. What is the background of EPA's action on the Florida PSD rule revisions? On December 31, 2002 (67 FR 80186), EPA published final rule changes to 40 Code of Federal Regulations
(CFR)parts 51 and 52, regarding the Clean Air Act (“CAA” or “Act”) PSD and nonattainment new source review
(NNSR)programs. On November 7, 2003 (68 FR 63021), EPA published a notice of final action on its reconsideration of the December 31, 2002, final rule changes. In that November 7, 2003, final action, EPA added the definition of “replacement unit,” and clarified an issue regarding plant-wide applicability limitations. Collectively, these EPA final actions are referred to as the “2002 NSR Reform Rules.” On June 13, 2007 (72 FR 32526), EPA took final action to revise the 2002 NSR Reform Rules to exclude the clean units and PCP provisions that were vacated by the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit Court) on June 24, 2005. Further, on December 21, 2007, EPA took final action on the portion of the 2002 NSR Reform Rules remanded by the D.C. Circuit Court, regarding the reasonable possibility in recordkeeping provision. The “reasonable possibility” provision identifies, for sources and reviewing authorities, the circumstances under which a major stationary source undergoing a modification that does not trigger major NSR must keep records. On December 21, 2007, EPA established that a “reasonable possibility” exists where source emissions equal or exceed 50 percent of the CAA NSR significance levels for any pollutant (72 FR 72607). These changes became effective on January 22, 2008, and the final action on that provision explains the process that states should follow if a SIP revision is necessary. 1 1 Florida's regulations do not include the “reasonable possibility” language. Florida's SIP revisions require all modifications that use the actual-to-projected-actual methodology to meet the recordkeeping requirements. Thus, with regard to the reasonable possibility issue, Florida's rules are at least as stringent as the current federal rules. The Florida SIP revisions being approved today revise Florida's PSD program consistent with the federal program. In so doing, Florida not only provided substantive revisions to its rules, but also reorganized the rules to better follow the outline of the corresponding federal rules. This reorganization does not have any substantive impact on the PSD program as a whole, or its relationship with Florida's operating permits program (CAA title V program). Florida's PSD program continues to work in concert with its title V operating permit program to ensure that applicable requirements, including any applicable PSD requirements, are a part of lawful operation of a source under Florida's title V program. The February 3, 2006, SIP submittal consists of revisions to the following FDEP rules: F.A.C. Chapter 62-204, “Air Pollution Control—General Provisions;” F.A.C. Chapter 62-210, “Stationary Sources—General Provisions;” and F.A.C. Chapter 62-212, “Stationary Sources—Preconstruction Review.” The revisions were made to update the Florida PSD program to make it consistent with the December 31, 2002, changes to the federal NSR program. EPA is conditionally approving the February 3, 2006, SIP submittal consistent with section 110(k)(4) of the CAA. As part of the conditional approval, Florida will have twelve months from the date of EPA's final conditional approval of the SIP revisions in which to further revise its PSD rules, as described herein, to be consistent with existing federal law. Pursuant to section 110(k)(4) of the CAA, EPA may conditionally approve a portion of a SIP revision based on a commitment from the state to adopt specific, enforceable measures no later than twelve months from the date of final conditional approval. If the state fails to make the changes within the twelve month period, EPA will issue a finding of disapproval. EPA is not required to propose the finding of disapproval. The necessary revisions to the Florida SIP will materially alter the existing SIP-approved rule. As a result, Florida must also provide a new SIP submittal to EPA for approval that includes the rule changes. As with any SIP revision, Florida must provide an opportunity for public notice and comment, and allow for a public hearing (and any other procedures required by State law) on the proposed rule changes. If Florida timely revises its rules and submits the revised SIP submittal, EPA will process that SIP revision consistent with the CAA. With regard to the conditional approval of the PSD program, Florida must:
(1)Revise the definition of “new emissions unit” to be consistent with the federal definition or revise the definition to define what is meant by “beginning normal operation” and provide an equivalency demonstration supporting the revised definition;
(2)revise the definition of “significant emissions rate” to include ozone depleting substances;
(3)withdraw the request that EPA include a significant emissions rate for mercury in the Florida SIP, specifically F.A.C. 62-210.200(243)(a)2; and
(4)revise the recordkeeping requirements at F.A.C. 62-212.300(3)(a)1 to require a record of the amount of emissions excluded pursuant to the projected actual emissions requirements, an explanation as to why these emissions were excluded, and any netting calculations if applicable, consistent with the federal recordkeeping requirements at 40 CFR 51.166(r)(6). The April 4, 2008, NPR and the docket for this action provide more details about the SIP revisions being approved and the rationale for EPA's final action. For additional information on EPA's 2002 NSR Reform Rules, see 67 FR 80186 (December 31, 2002), and *http://www.epa.gov/nsr.* III. What is the background of EPA's action on Florida's PSD program for electric power plants? Electric power plants subject to the Florida PPSA have historically been permitted by FDEP (through a federal delegation of authority from EPA) under the federal PSD program rather than the Florida SIP-approved PSD permitting program. The Florida PSD program was initially approved by EPA into the Florida SIP on December 22, 1983 (48 FR 52713). The approval transferred to FDEP the legal authority to process and issue PSD permits to sources in Florida that are required to obtain PSD permits. One category of sources not covered by EPA's 1983 approval of Florida's PSD program was electric power plants. This was because, at the time, a separate Florida law known as the Florida PPSA, Florida Statutes Section 403.501 *et seq.* , required permits for electric power plants to be issued solely by the Power Plant Site Certification Board under the PPSA, rather than by FDEP under Florida's PSD regulations. Such a conflict between the PPSA and Florida's PSD program created impediments to implementation and enforcement of the State's PSD program by FDEP for such power plants and precluded EPA's SIP-approval of Florida's PSD program as to these sources. As a result, for electric power plants subject to the PPSA, FDEP has been operating under either a partial or full delegation of authority to implement the federal PSD program since 1983, while various attempts to amend the PPSA to correct the conflict were made. Currently, FDEP is operating under a full delegation of authority to implement the federal PSD program for electric power plants, following further amendments to the PPSA in 1993. The 1993 PPSA amendment made clear that FDEP is the final permitting authority for PSD and new source review permits and can act in a manner different from the PPSA Siting Board if Florida's PSD or new source review regulations require such different action. The statutory amendment to the PPSA made by the Florida Legislature in 1993 forms the basis of the State's 2006 request for EPA approval to make Florida's SIP-approved State PSD program, rather than the federal PSD program, applicable to sources subject to the PPSA. In addition, during EPA's review of this request, the PPSA was again amended (on June 19, 2006), to among other things, further extricate Florida's PSD permitting process from its PPSA process. See, Florida Public Health Code 403.0872. Following EPA review of both the 1993 and June 19, 2006, amendments to the PPSA, the Agency published a direct final rule on May 25, 2007, finding that the PPSA amendments provided FDEP the authority to fully implement and enforce Florida's PSD program for electric power plants located within the State, and we granted it full approval to implement the State's PSD program for electric power plants subject to the PPSA. 72 FR 29287 (May 25, 2007). However, because adverse comments on the direct final rule were received, EPA withdrew the rule on June 28, 2007 (72 FR 35355) and indicated that the rule would not take effect. As is described in greater detail in the April 4, 2008, proposal, the 1993 and June 2006 Florida legislative amendments to the State's PPSA rectified past concerns that the Florida PPSA infringed on FDEP's authority to issue State PSD permits to sources subject to both the State's PSD regulations and the Florida PPSA in such a manner that SIP-approval of the State's PSD program for those sources was precluded. By proposing this SIP-approval through this new rulemaking process, and in conjunction with our proposed action on the Florida PSD program SIP revisions, we have addressed the main concerns raised by commenters in response to our May 25, 2007, direct final rule. For additional information on the concerns raised by commenters, see the April 4, 2008, proposal. EPA is now approving Florida's February 3, 2006, request that EPA grant Florida SIP-approval to implement the State's PSD program for electric power plants subject to the PPSA. EPA is approving this specific request under section 110 of the Act because there is no longer a conflict between the State's PSD regulations and the PPSA and because FDEP now has adequate and effective procedures for full implementation of the State's PSD program for electric power plants. The April 4, 2008, NPR and the docket for this action provide more details about the approval of Florida's PSD program for electric power plants and the rationale for EPA's final action. IV. Final Action EPA is taking final action to conditionally approve changes to the Florida Administrative Code Chapter 62-204 entitled “Air Pollution Control—General Provisions”; Chapter 62-210 entitled “Stationary Sources—General Provisions”; and Chapter 62-212 entitled “Stationary Sources—Preconstruction Review,” as submitted by the State of Florida on February 3, 2006, as revisions to the Florida SIP. In addition to and in conjunction with the conditional approval of Florida's PSD SIP revisions, EPA is taking final action to approve Florida's concurrent February 3, 2006, request to make the State's PSD permitting program applicable to electric power plants subject to the Florida PPSA. As a result of this final action, EPA's October 26, 1993, federal delegation of PSD authority to FDEP will be withdrawn effective July 28, 2008. This final approval means that Florida's SIP-approved PSD permitting program, including the final conditional approval of the State's PSD revisions noted above, applies to electric power plants in Florida in lieu of the current federally delegated PSD program. V. Statutory and Executive Order Reviews Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action: • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ); • 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); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 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 action 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 26, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: June 16, 2008. J.I. Palmer, Jr., Regional Administrator, Region 4. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart K—Florida 2. Section 52.519 is revised to read as follows: § 52.519 Identification of plan-conditional approval. EPA is conditionally approving a revision to the Florida State Implementation Plan
(SIP)consisting of revisions to Florida Administrative Code Chapters 62-210 and 62-212. Based upon a commitment from the State, Florida must
(1)revise the definition of “new emissions unit” to be consistent with the federal definition or revise the definition to define what is meant by “beginning normal operation” and provide an equivalency demonstration supporting the revised definition;
(2)revise the definition of “significant emissions rate” to include ozone depleting substances;
(3)withdraw the request that EPA include a significant emissions rate for mercury in the Florida SIP, specifically F.A.C. 62-210.200(243)(a)2; and
(4)revise the recordkeeping requirements at F.A.C. 62-212.300 to be consistent with federal requirements. If the State fails to meet its commitment by June 29, 2009, the approval is treated as a disapproval. 3. Section 52.520(c) is amended by: a. Revising entries under Chapter 62-204 for “62-204.200,” and “62-204.260,” under Chapter 62-210 for “62-210.200,” “62-210.300,” “62-210.350”and “62-210.370,” under Chapter 62-212 for “62-212.300,” “62-212.400,” and “62-212.500” and b. Adding in numerical order a new entry under Chapter 62-212 for “62-212.720” to read as follows: § 52.520 Identification of plan.
(c)* * * EPA-Approved Florida Regulations State citation Title/subject State effective date EPA approval date Explanation Chapter 62-204 Air Pollution Control—General Provisions * * * * * * * 62-204.200 Definitions 02/12/06 06/27/08 [Insert citation of publication] * * * * * * * 62-204.260 Prevention of Significant Deterioration Maximum Allowable Increases (PSD Increments) 02/12/06 06/27/08 [Insert citation of publication] * * * * * * * Chapter 62-210 Stationary Sources—General Requirements * * * * * * * 62-210.200 Definitions 02/02/06 06/27/08 [Insert citation of publication] Except for the following definitions which are being conditionally approved:
(1)“New emissions unit;” and
(2)“significant emissions rate.” * * * * * * * 62-210.300 Permits Required 02/02/06 06/27/08 [Insert citation of publication] 62-210.350 Public Notice and Comment 02/02/06 06/27/08 [Insert citation of publication] * * * * * * * 62-210.370 Emissions Computation and Reporting 02/02/06 06/27/08 [Insert citation of publication] * * * * * * * Chapter 62-212 Stationary Sources—Preconstruction Review * * * * * * * 62-212.300 General Preconstruction Review Requirements 02/02/06 06/27/08 [Insert citation of publication] Except provisions at 62-212.300(3)(a)1, which are being conditionally approved. 62-212.400 Prevention of Significant Deterioration
(PSD)02/02/06 06/27/08 [Insert citation of publication] 62-212.500 Preconstruction Review for Nonattainment Areas 02/02/06 06/27/08 [Insert citation of publication] * * * * * * * 62-212.720 Actuals Plantwide Applicability Limits
(PALs)02/02/06 06/27/08 [Insert citation of publication] 4. Section 52.530 is amended by revising paragraph
(a)to read as follows: § 52.530 Significant deterioration of air quality.
(a)EPA approves the Florida Prevention of Significant Deterioration program, as incorporated into this chapter, for power plants subject to the Florida Power Plant Siting Act. [FR Doc. E8-14400 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2007-0998; FRL-8684-1] Approval and Promulgation of State Implementation Plans: Washington; Vancouver Air Quality Maintenance Area Second 10-Year Carbon Monoxide Maintenance Plan AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action to approve a State Implementation Plan
(SIP)revision submitted by the State of Washington. The Washington State Department of Ecology submitted the Vancouver Air Quality Maintenance Area Second 10-year Carbon Monoxide Maintenance Plan on April 25, 2007. In accordance with the requirements of the Federal Clean Air Act (the Act), EPA is approving Washington's revision because the State adequately demonstrates that the Vancouver Air Quality Maintenance Area will maintain air quality standards for carbon monoxide
(CO)through the year 2016. DATES: This rule is effective on August 26, 2008, without further notice, unless EPA receives adverse comment by July 28, 2008. If EPA receives adverse comment, we will publish a timely withdrawal in the **Federal Register** informing the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-OAR-2007-0998, by any of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: vaupel.claudia@epa.gov* . • *Mail:* Claudia Vergnani Vaupel, U.S. EPA Region 10, Office of Air, Waste and Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA 98101. • Hand Delivery/Courier: U.S. EPA Region 10, 1200 Sixth Avenue, Suite 900, Seattle, WA 98101. Attention: Claudia Vergnani Vaupel, Office of Air, Waste and Toxics, AWT—107. Such deliveries are only accepted during normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R10-OAR-2007-0998. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , 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. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy during normal business hours at the Office of Air, Waste and Toxics, U.S. EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101. FOR FURTHER INFORMATION CONTACT: Claudia Vergnani Vaupel at telephone number:
(206)553-6121, e-mail address: *vaupel.claudia@epa.gov* , fax number:
(206)553-0110, or Gina Bonifacino at telephone number:
(206)553-2970, e-mail address: *bonifacino.gina@epa.gov* , or the above EPA, Region 10 address. SUPPLEMENTARY INFORMATION: Table of Contents I. General Information II. What is the Purpose of this Action? III. What is the Background for this Action? IV. How Have the Public and Stakeholders Been Involved in this Rulemaking Process? V. Evaluation of Washington's Submittal VI. Transportation and General Conformity VII. Final Action VIII. Statutory and Executive Order Reviews I. General Information A. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through RME, regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations
(CFR)part 2. 2. Tips for Preparing Your Comments. When submitting comments, remember to: i. Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions—The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns, and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. What Is the Purpose of This Action? EPA is taking direct final action to approve the Second 10-year CO Maintenance Plan for the Vancouver, Washington Air Quality Maintenance Area. Vancouver attained the CO national ambient air quality standards (NAAQS) in 1996 and has not violated the standard since 1990. The second 10-year CO maintenance plan submitted by the state of Washington is designed to keep the Vancouver area in attainment for the CO standard for a second ten-year period beyond redesignation. III. What Is the Background for This Action? Under section 107(d)(1)(C) of the Act, any area designated before the date of enactment of the Clean Air Act Amendments of 1990
(CAAA)was to be designated upon enactment by operation of law. Under section 107(d)(1)(A) of the Act, States were required by 120 days after enactment of the CAAA, to submit lists designating all areas of the State as attainment, unclassifiable, or nonattainment. Accordingly, on March 15, 1991, letters were submitted by the governors of Washington and Oregon to the EPA Region 10 Administrator recommending the Vancouver and Portland areas, respectively, be designated as nonattainment for CO. On November 6, 1991 (56 FR 56694) the areas were designated by EPA as nonattainment for CO and classified as “moderate” with design values less than or equal to 12.7 parts per million
(ppm)under the provisions outlined in sections 186 and 187 of the Act. On September 29, 1995 (60 FR 50423) EPA divided the Portland-Vancouver area into separate nonattainment areas for each state. The State of Washington, following the requirements of the Act, prepared and submitted revisions to the Washington SIP that first included an attainment plan, and then developed a plan to demonstrate maintenance of the standard for a 10-year period beyond the statutory attainment date. EPA published approval of a redesignation request to attainment and the first 10-year maintenance plan on October 21, 1996 (61 FR 54560). The first 10-year CO maintenance plan included a commitment for periodic review of the plan and submission of the second 10-year maintenance plan. The State of Washington submitted a second 10-year maintenance plan to EPA on April 25, 2007. The national 8-hour CO ambient standard is attained when the daily average 8-hour CO concentration of 9.0 ppm is not exceeded more than once a year. Since the redesignation of the Vancouver area to attainment for CO on October 21, 1996, the second highest concentration in any calendar year measured by the approved monitoring network was 6.7 ppm, which is less than 9.0 ppm. Therefore the area is attaining the CO NAAQS. In addition, areas that can demonstrate design values at or below 7.65 ppm (85 percent of exceedance levels of the CO NAAQS) for 8 consecutive quarters may use a Limited Maintenance Plan option. The current 8-hour CO design value for the Vancouver area is 4.8 ppm based on 2004-2005 data. The State of Washington has opted to develop a Limited Maintenance Plan to fulfill the Vancouver Area second 10-year maintenance period required by the Act. IV. How Have the Public and Stakeholders Been Involved in This Rulemaking Process? Section 110(a)(2) of the Act requires that each SIP revision be adopted after reasonable notice and public hearing. This must occur prior to the revision being submitted by a State to us. The state of Washington held a public hearing on March 1, 2007 in Vancouver, Washington. A notice of public hearing was published in *The Columbian* on January 29, 2007. A notice was also published in the Washington State Register on February 7, 2007. This SIP revision became State effective on April 9, 2007, and was submitted by the Governor's designee to us on April 25, 2007. EPA has evaluated the State's submittal and determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the Act. V. Evaluation of Washington's Submittal EPA has reviewed the State's revised CO maintenance plan for the Vancouver air quality maintenance. This revision provides the second 10-year update to the maintenance plan for the area, as required by section 175A(b) of the Act. The following is a summary of the requirements and EPA's evaluation of how each requirement is met. A. Base Year Emissions Inventory The plan must contain an attainment year emissions inventory to identify a level of emissions in the area which is sufficient to attain the CO NAAQS. The Vancouver CO second 10-year maintenance plan contains an emissions inventory for the base year 2002 that is consistent with EPA's most recent guidance on maintenance plan emission inventories. The emissions inventory is a list, by source, of the air contaminants directly emitted into the Vancouver CO area. The data in the emissions inventory is based on calculations and is developed using emission factors, which is a method for converting source activity levels into an estimate of emissions contributions for those sources. Because violations of the CO NAAQS are most like to occur on winter weekdays, the inventory prepared is in a “typical winter day” format. The table below shows the pounds of CO emitted per winter day in 2002 by source category. 2002 Emission Inventory, Main Source Category Subtotals Main source category CO emissions pounds per winter day (lb/d) Point Sources 4,396 Onroad Mobile Sources 383,058 Non-road Mobile Sources 56,837 Area Sources 126,377 Total 570,669 B. Demonstration of Maintenance The maintenance plan demonstration requirement is considered to be satisfied for areas using the Limited Maintenance Plan option, which are required to demonstrate design values at or below 7.65 ppm (85 percent of exceedance levels of the CO NAAQS) for 8 consecutive quarters. The State of Washington has opted to develop a Limited Maintenance Plan to fulfill the Vancouver Area second 10-year maintenance period required by the Act. With the Limited Maintenance Plan option, there is no requirement to project emissions of air quality over the maintenance period. EPA believes that if the area begins the maintenance period at, or below, 85 percent of the level of the CO 8-hour NAAQS, the applicability of prevention of significant deterioration requirements, the control measures already in the SIP, and Federal measures, should provide adequate assurance of maintenance over the 10-year maintenance period. The last monitored violation of the CO NAAQS in Vancouver occurred in 1990 and monitored CO levels have been steadily in decline ever since. The current 8-hour CO design value for the Vancouver CO area is 4.8 ppm based on 2004-2005 data, which is below the limited maintenance plan requirement of 7.65 ppm. Therefore, the Vancouver area has adequately demonstrated that it will maintain the CO NAAQS into the future. C. Monitoring Network and Verification of Continued Attainment To verify the attainment status of the area over the maintenance period, the maintenance plan should contain provisions for continued operation of an appropriate, EPA-approved monitoring network in accordance with 50 CFR part 58. The State of Washington has an approved monitoring network that includes the Vancouver area. The monitoring network was most recently approved by EPA on November 16, 2007. In 2006, the Southwest Clean Air Agency requested permission to remove the CO monitor at the Atlas and Cox site in Vancouver and EPA concurred that monitoring could be discontinued at the site. The State is continuing to verify attainment by conducting a triennial review of CO emissions from the countywide emissions inventory. D. Contingency Plan Section 175A(d) of the Act requires that a maintenance plan include contingency provisions. The Vancouver Area CO Maintenance Plan contains a tiered level of response should the triennial emission inventory show that annual county-wide on road mobile emissions have increased over 2005 levels. The contingency plan calls for analysis of appropriate emission reduction measures and their implementation. VI. Transportation and General Conformity Transportation conformity is required by section 176(c) of the Clean Air Act. EPA's conformity rule requires that transportation plans, programs, and projects that are funded under 23 U.S.C. or the Federal Transit Act conform to SIPs. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS. The transportation conformity rule (40 CFR parts 51 and 93) and the general conformity rule (40 CFR parts 51 and 93) apply to nonattainment areas and maintenance areas covered by an approved maintenance plan. Under either conformity rule, an acceptable method of demonstrating that a Federal action conforms to the applicable SIP is to demonstrate that expected emissions from the planned action are consistent with the emissions budget for the area. While EPA's Limited Maintenance Plan option does not exempt an area from the need to affirm conformity, it explains that the area may demonstrate conformity without submitting an emissions budget. Under the Limited Maintenance Plan option, emissions budgets are treated as essentially not constraining for the length of the maintenance period because it is unreasonable to expect that the qualifying areas would experience so much growth in that period that a violation of the CO NAAQS would result. Similarly, Federal actions subject to the general conformity rule could be considered to satisfy the “budget test” specified in section 93.158(a)(5)(i)(A) for the same reasons that the budgets are essentially considered to be unlimited. 1. Transportation Conformity While areas with maintenance plans approved under the Limited Maintenance Plan option are not subject to the budget test, the areas remain subject to other transportation conformity requirements of 40 CFR part 93, subpart A. Thus, the metropolitan planning organization
(MPO)in the area or the State must document and ensure that: a. Transportation plans and projects provide for timely implementation of SIP transportation control measures in accordance with 40 CFR 93.113; b. Transportation plans and projects comply with the fiscal constraint element per 40 CFR 93.108; c. The MPO's interagency consultation procedures meet applicable requirements of 40 CFR 93.105; d. Conformity of transportation plans is determined no less frequently than every four years, and conformity of plan amendments and transportation projects is demonstrated in accordance with the timing requirements specified in 40 CFR 93.104; e. The latest planning assumptions and emissions model are used as set forth in 40 CFR 93.110 and 40 CFR 93.111; f. Projects do not cause or contribute to any new localized carbon monoxide or particulate matter violations, in accordance with procedures specified in 40 CFR 93.123; and g. Project sponsors and/or operators provide written commitments as specified in 40 CFR 93.125. EPA meets at least annually with the Washington Department of Ecology, the Southwest Clean Air Agency, the Federal Highway Administration, the Southwest Washington Regional Transportation Council, and the Washington Department of Transportation to review documentation and the Transportation Improvement Plan for the Vancouver area and determine if the area is meeting the transportation conformity requirements under 40 CFR part 93. Vancouver is currently meeting the requirements under 40 CFR part 93, subpart A. On November 19, 2007, EPA posted a notice finding the Vancouver CO second 10-year maintenance plan adequate for transportation conformity purposes. (See 72 FR 65019.) VII. Final Action In accordance with the requirements of the Federal Clean Air Act (the Act), EPA is approving this revision to the State Implementation Plan
(SIP)because the State adequately demonstrates that the Vancouver Air Quality Maintenance Area will maintain air quality standards for CO through the year 2016. EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this **Federal Register** publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective August 26, 2008 without further notice unless the Agency receives adverse comments by July 28, 2008. If EPA receives such comments, then EPA will publish a timely withdrawal of the direct final rule informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period on this rule. Any parties interested in commenting on this rule should do so at this time. If no such comments are received, the public is advised that this rule will be effective on August 26, 2008 and no further action will be taken on the proposed rule. VIII. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ); • 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); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 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 action 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 26, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action 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, Reporting and recordkeeping requirements. Dated: June 10, 2008. Michelle Pirzadeh, Acting Regional Administrator, EPA Region 10. For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart WW—Washington 2. Section 52.2475 is amended by adding paragraph (a)(4) to read as follows: § 52.2475 Approval of plans.
(a)* * *
(4)Vancouver.
(i)EPA approves as a revision to the Washington State Implementation Plan, the Vancouver Air Quality Maintenance Area Second 10-year Carbon Monoxide Maintenance Plan submitted by the Washington Department of Ecology on April 25, 2007.
(ii)[Reserved] [FR Doc. E8-14518 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 401 [CMS-6032-F] RIN 0938-AO27 Medicare Program; Use of Repayment Plans AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule modifies Medicare regulations to implement section 935(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 pertaining to the use of repayment plans (also known as extended repayment schedules or “ERS”) for Medicare provider and supplier overpayments. Under this provision, we are granting a provider or a supplier an ERS under certain terms and conditions as defined in the statute. This final rule establishes criteria and procedures to apply this requirement and to define the concepts of “hardship” and “extreme hardship.” DATES: *Effective Date:* These regulations are effective on July 28, 2008. FOR FURTHER INFORMATION CONTACT: Tom Noplock,
(410)786-3378. SUPPLEMENTARY INFORMATION: I. Background A. Medicare Overpayment Medicare overpayments are Medicare funds an individual, provider, or supplier has received that exceed amounts due and payable under the Medicare statute and regulations (plus any applicable interest and penalties assessed on the overpayment). Section 400.202 defines a “supplier” as “a physician or other practitioner, or an entity other than a provider, that furnishes health care services under Medicare.” Generally, overpayments result when payment is made by Medicare for items or services that are not covered, exceeds the amount allowed by Medicare for an item or service, or is made for items or services that should have been paid by another insurer (for example, Medicare secondary payer obligations). Once a determination and any necessary adjustments in the amount of the overpayment have been made, the remaining amount is a debt owed to the United States Government. Section 1870 of the Social Security Act (the Act) provides a framework within which liability for such Medicare overpayments is determined and recoupment of overpayments is pursued. This framework prescribes a decision making process that the agency follows when pursuing the recoupment of Medicare overpayments. The regulation governing the liability for Medicare overpayments is located at 42 CFR part 401 (subpart F). B. Statutory Authority The Federal Claims Collection Act of 1966 (Pub. L. 89-508) (FCCA), 80 Stat. 308 (amended by the Debt Collection Improvement Act of 1996 (Pub. L. 104-134)
(DCIA)(codified at 31 U.S.C. 3711)) is the Federal government's basic statutory authority for debt management practices. The Congress intended the FCCA to reduce the amount of litigation previously required to collect claims and to reduce the volume of private relief legislation in the Congress. The FCCA was intended to be independent of the other authorities we use to collect debt and added to, rather than supplanted, our other authorities, including common law authority. The FCCA authorized the head of an agency to collect claims in any amount. This statute also provided that the head of an agency may, under certain conditions, compromise a claim, or suspend or terminate collection action on a claim. Uncollectible claims in excess of $100,000, exclusive of interest, must be referred to the Department of Justice for compromise. The FCCA was amended in 1996 and is now referred to as the Debt Collection Improvement Act of 1996 (Pub. L. 104-134) (DCIA), 110 Stat. 1321, 1358 (April 26, 1996) (codified at 31 U.S.C. 3711). In the November 2, 1977 **Federal Register** (42 FR 57351), the Secretary of the Department of Health and Human Services (the Secretary) published a rule to delegate authority to the Department Claims Officer generally, and the Administrator of the Centers for Medicare & Medicaid Services (the Administrator) for necessary claims collection actions under our programs. The authority delegated to the Administrator covers all of our activities in the Medicare program (Title XVIII) and pertains to claims up to $20,000. (This amount has been increased to $100,000; see 31 U.S.C. 3711.) In the August 29, 1983 **Federal Register** (48 FR 39060), we published the “Federal Claims Collection Act; Claims Collection and Compromise” final rule with comment period in accordance with the FCCA. In that final rule with comment period, we adopted the applicable debt collection tools made available to us under the FCCA including the ability to collect or compromise claims, or suspend or terminate collection action, as appropriate. The final rule with comment period also set forth the requirements we use to evaluate debtors' requests for extended repayment agreements specified in § 401.607. As part of the Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) (HIPAA), the Congress added section 1893 to the Act establishing the Medicare integrity program
(MIP)to carry out Medicare program integrity activities that are funded from the Medicare Trust Funds. Section 1893 of the Act expands our contracting authority to allow us to contract with eligible entities to perform MIP activities. These activities include review of provider and supplier activities including medical, fraud, and utilization review; cost report audits; Medicare secondary payer determinations; education of providers, suppliers, beneficiaries, and other persons regarding payment integrity and benefit quality assurance issues; and developing and updating a list of durable medical equipment items that are subject to prior authorization (42 U.S.C. 1395ddd). These MIP contractors assist us in the identification and collection of Medicare provider and supplier overpayments. C. Overview of Current Policy The current policy that CMS and its contractors use for the evaluation of extended repayment schedules
(ERSs)is based on the existing regulations at § 401.607(c)(2) and guidance in the Medicare Financial Management Manual, Pub. 100-6 (Chapter 4, Section 50). Under our current policy, we determine the frequency and amount of the installment payments based on the factors set forth at the current § 401.607(c)(2) which include the following:
(1)The amount of the claim;
(2)the debtor's ability to pay; and
(3)the cost to CMS of administering an installment agreement. Under the current ERS review process, we primarily focus on the second factor, the debtor's ability to repay the overpayment, by conducting a review of the debtor's financial status, similar to how banks assess applicants for a loan. In almost all cases, we try to work with the provider or supplier to recover the overpayment. In general, it has been our experience that it is in both CMS and the debtor's best interests to work out a reasonable repayment schedule to recoup an overpayment rather than demand immediate collection of the debt within 30 days, which could place a provider or supplier at financial risk or bring the provider or supplier a step closer to bankruptcy. Under our existing procedures we review financial documentation submitted by the provider or supplier to assess the provider's or supplier's ability to repay the Medicare overpayment. This documentation must include, at a minimum, a statement of financial position (for example, a balance sheet), a statement of financial performance (for example, an income statement), and a statement of future viability (for example, a projected statement of cash flow). In addition, the provider must include a letter from a financial institution proving that it cannot obtain financing from an alternative source. D. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 On December 8, 2003, the Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) (MMA). This legislation contained provisions affecting the recovery of provider and supplier overpayments under the Medicare program. Section 935(a) of the MMA amended title XVIII of the Act by adding a new section 1893(f)(1) to the Act to require us to use certain statutory criteria in evaluating whether a provider or supplier should be granted a repayment schedule of at least 6 months and up to 5 years. II. Provisions of the Proposed Regulations The following is an overview of the provisions we proposed in the Use of Repayment Plans proposed rule published in the November 27, 2006 **Federal Register** (71 FR 68519). 1. Hardship Provision Under section 1893(f)(1) of the Act, we may grant a provider or a supplier upon request, a repayment schedule of at least 6 months, if repaying an overpayment within 30 days would constitute a “hardship” on the provider or supplier, provided that certain criteria are met. The new statute at section 1893(f)(1)(B)(i) of the Act defines “hardship” based on the relationship between the amount of the Medicare overpayment(s) not covered under an existing ERS owed by a provider or supplier and the total amount of Medicare payments made to that provider or supplier over the most recently submitted cost report or for the previous calendar year. Under section 1893(f)(1)(B) of the Act, a provider or supplier's repayment of an overpayment within 30 days is deemed to be a “hardship” when the total amount of all outstanding overpayments not included in an approved existing repayment schedule is 10 percent or greater than the total Medicare payments made for the cost reporting period covered by the most recently submitted cost report (for a provider filing a cost report), or the previous calendar year (for a supplier or non cost report provider). We proposed to interpret “outstanding overpayments” to include both principal and accrued interest. We read the newly added section 1893(f)(1)(B)(iii) of the Act to exclude overpayments already being repaid under an approved ERS. We proposed to interpret the new “hardship” test under section 935(a) of the MMA as not to supersede our ERS regulations currently at § 401.607(c)(2), (which we proposed to redesignate as § 401.607(c)(3)). Since our existing regulations governing ERSs are issued under the FCCA, we do not plan to eliminate the criteria and procedures currently used to grant providers and suppliers ERSs. Instead, we proposed to add an initial “hardship” test to existing regulations and procedures for determining a debtor's ERS. We proposed that all requests for an ERS first be evaluated under the new “hardship” test. Under section 935(a) of the MMA, if “hardship” is determined and no statutory exception applies under § 401.607(c)(2)(iv), then the statute requires that the Secretary grant a provider or supplier a repayment period of at least 6 months but not longer than 3 years. Section 935(a) of the MMA requires that the Secretary establish rules for cases when a provider or a supplier was not paid during the previous year or paid for only a portion of that year. For these cases, we proposed to use the last 12 months of Medicare payments made to the provider or supplier. In cases where there is less than a 12-month payment history, we proposed that the number of months available be annualized to equal an approximate yearly Medicare payment level for the provider or supplier. (For detailed examples on how to apply the new “hardship” test provided in section 1893(f)(1) of the Act, please see the November 27, 2006 proposed rule, “Use of Repayment Plans” (71 FR 68521).) 2. Exceptions Under the “Hardship” Provision in Section 935(a) of the MMA Section 935(a) of the MMA sets out exceptions to granting a provider or supplier an extended repayment schedule even if the provider or supplier meets the “hardship” test. These exceptions occur when there is reason to suspect the provider or supplier may file for bankruptcy, cease to do business, discontinue participation in the program, or when there is an indication of fraud or abuse committed against the program. (We proposed that contractors continue to use existing procedures and definitions applicable to bankruptcy and fraud or abuse.) In such cases, CMS or its contractors are prohibited from granting an ERS. 3. Extreme Hardship Provision Under the provisions of § 401.607(c)(2)(vi) of this final rule, the Secretary may grant a provider or a supplier a repayment schedule of 36 months and up to 60 months if repaying an overpayment would constitute an “extreme hardship” unless a statutory exception applies under § 401.607(c)(2)(iv). Since the Congress left the definition of “extreme hardship” to our discretion, we considered different approaches for defining “extreme hardship” and sought public comment on this section. We considered proposing a new financial threshold to determine if a provider or supplier was in extreme financial hardship, such as using a 15 percent threshold. We rejected this approach because it could result in discriminating against providers and suppliers who may be similarly financially situated but may attribute more of their total revenue to Medicare income. This could occur for example with a home health agency
(HHA)which may attribute 100 percent of its revenue to Medicare business and a skilled nursing facility
(SNF)which may only attribute 20 percent of its business to Medicare. We proposed to define “extreme hardship” when a provider or supplier qualifies under the “hardship” provision defined above and the provider's or supplier's request for an ERS is approved under newly redesignated § 401.607(c)(3). If we determine the request meets the criteria in the redesignated § 401.607(c)(3) and meets the CMS manual guidance set forth in the Medicare Financial Management Manual, Pub. 100-6, Chapter 4, Section 50, we proposed that the provider or supplier may be granted an ERS between 36 and 60 months. We also proposed that contractors apply the statutory exceptions to “extreme hardship” cases in a similar manner as they do to “hardship” cases. We solicited comments on other alternative approaches to define “extreme hardship” that could distinguish between the most extreme cases requiring ERSs between 36 and 60 months. 4. Extended Repayment Schedules
(ERSs)We proposed to initially handle ERS requests differently than we have under our current regulations. We proposed to allow providers or suppliers that meet the “hardship” test and request only a 6-month ERS period, the opportunity to pay back the Medicare debt in 6 months without having to submit financial documentation to the contractor in accordance with the existing instructions in the Medicare Financial Management Manual, CMS, Pub. 100-6, Chapter 4, Section 50. We believe that by waiving the requirement to submit financial documentation (such as financial statements or a bank denial letter) for a 6-month ERS, we allow a provider or supplier time to generate or secure the necessary capital to liquidate the debt without having to file extensive documentation in order to secure a repayment schedule. We therefore proposed that a provider or supplier that requests a 6-month ERS, meets the “hardship” test, does not fall within an exception, and elects not to submit financial documentation would be approved for a 6-month ERS. Any provider or supplier qualifying for the 6-month ERS under the “hardship” provision has the choice to turn down the 6-month ERS and either pay off the debt within 30 days of the date of determination or request a longer than 6-month ERS. In addition, we proposed not to prohibit any provider or supplier under the 6-month “hardship” provision ERS from applying for a longer ERS if it later desires to do so under § 401.607(c)(3). For all ERS requests greater than 6 months, we proposed to rely on current regulations and procedures that require the provider or supplier to submit financial documentation in accordance with the Medicare Financial Management Manual, CMS Pub. 100-6, Chapter 4, Section 50. A provider or supplier must continue to submit a written request that refers to the specific overpayment for which an ERS is being requested, the number of months requested in the ERS, and include the first payment with its request. The contractor would determine the duration of the ERS based on its review of the provider or supplier's documentation in accordance with CMS manual guidance. If a provider or supplier misses one installment payment in any ERS granted under section 935(a) of the MMA, the statute permits us to immediately collect the entire overpayment. However, we proposed to impose this penalty only on the “automatic” 6-month ERS. With all other ERSs, we proposed to continue to use the existing procedures that define a default of an ERS as missing two consecutive installment payments. We proposed to revise § 401.601(a) to read as follows: “This subpart implements the following provisions:
(1)For CMS the Debt Collection Improvement Act of 1996 (Pub. L. 104-134) (DCIA), 110 Stat. 1321, 1358 (April 26, 1996) (codified at 31 U.S.C. 3711), and conforms to the regulations (31 CFR parts 900-904) issued jointly by the Department of the Treasury and the Department of Justice that generally prescribe claims collection standards and procedures under the DCIA for the Federal government;
(2)section 1893(f)(1) of the Act regarding the use of repayment plans.” In addition, in § 401.603 we proposed to add a definition for an “extended repayment schedule.” We proposed to redesignate § 401.607(c)(2) as § 401.607(c)(3). In addition, we proposed a new § 401.607(c)(2), Extended repayment schedule, in accordance with section 1893(f)(1) of the Act. We proposed to implement the provisions of section 1893(f)(1) of the Act, as amended by section 935(a) of the MMA, in new § 401.607(c)(2), Extended repayment schedule. III. Analysis of and Responses to Public Comments We received 6 public comments on the November 27, 2006 proposed rule. The following is a summary of the major issues and our responses. *Comment:* One commenter believed that the provisions of the proposed rule were not equitable between provider types because 10 percent of total Medicare reimbursement for a provider with a 50 percent Medicare fee-for-service revenue is a greater threshold to reach than a provider with a 5 percent Medicare fee-for-service revenue. *Response:* We agree with the comment that the proposed rule may not in all cases treat different provider types similarly. However, the statute was written to define hardship as a ratio of Medicare overpayments to total Medicare payments/reimbursement in a given time period. The statute does not allow CMS to take into account the percentage of patient revenue from other sources when defining “hardship.” For all other ERS requests, we proposed to rely on current regulations and procedures that require the provider or supplier to submit financial documentation in accordance with the Medicare Financial Management Manual, CMS Pub. 100-6, Chapter 4, Section 50. *Comment:* Some commenters believed it would be more consistent and more fair to providers if we would use the definition of default for all ERSs as missing two consecutive installment payments. *Response:* While the statute permits us to immediately collect on an entire overpayment if a provider or supplier misses one installment payment in any ERS granted under section 935(a) of the MMA, we have decided to impose the 1-month missed payment rule only for the 6-month “hardship-based” ERS. We chose not to apply the two missed payment rule to 6-month ERSs because we do not want a provider or supplier to be too far in arrears if they miss payments in such a short ERS. A provider or supplier that is behind two payments in a 6-month ERS has a greater amount of its payments in arrears than a provider or supplier that is behind two payments in a 36-month or 60-month ERS. For example, two missed payments on the amortization of an overpayment covered under a 6-month ERS (2 divided by 6) is equal to approximately 33.3 percent of the total overpayment whereas 2 missed payments under a 36-month ERS (2 divided by 36) is equal to a much lower 5.5 percent of the total overpayment. On a 60-month ERS, two missed payments would only equal 3.3 percent of the total overpayment (2 divided by 60). *Comment:* Some commenters were concerned that we may be inadvertently legally binding providers to the “automatic” 6-month ERS and not offering providers a future opportunity to request a second ERS under § 401.607(c). *Response:* In the proposed rule, we stated that any provider or supplier qualifying for the 6-month ERS under the “hardship” provision has the choice to turn down the 6-month ERS and either pay off the debt within 30 days of the date of determination or request a longer ERS under newly redesignated § 401.607(c)(3). In addition, we will not prohibit any provider or supplier under the 6-month “hardship” provision ERS from applying for a longer ERS if it later desires to do so under § 401.607(c)(3). *Comment:* One commenter believed that there is no practical reason for why we have not adopted a parallel numerical threshold approach to extreme hardship by using some percentage above the numerical 10 percent threshold for hardship. *Response:* The 10 percent used in this final rule to define hardship is required by statute. As stated in the proposed rule, we considered proposing a new financial threshold to determine if a provider or supplier was in extreme financial hardship, such as using a 15 percent threshold. However, we rejected this approach because it could result in discriminating against providers and suppliers who may be similarly financially situated but may attribute more of their total revenue to Medicare income. This could occur for example with a home health agency
(HHA)which may attribute 100 percent of its revenue to Medicare business and a skilled nursing facility
(SNF)which may only attribute 20 percent of its business to Medicare. In addition, the ERS review process is a multivariable financial analysis and it would not be practical or equitable to either the provider/supplier or the Medicare program to reduce the ERS process down to a single variable. We believe keeping the definition of extreme hardship broader than a single variable is in the best interests of the provider and supplier community and is the most effective way to ensure that overpayments will be collected and returned to the Medicare Trust Fund. *Comment:* One commenter stated that there is confusion as to why the burden of producing financial documentation can be removed for the “automatic” 6-month ERS but not for ERS plans longer than 6 months. *Response:* We removed the financial documentation requirement for 6-month ERSs because the contractor already has the requisite information needed to determine if a provider or supplier meets the statutory hardship test. However, in order to grant an ERS longer than 6 months, we continue to need financial documentation to determine a provider or supplier's ability to make future ERS payments. We also need financial data to determine the length of the ERS or payback period that should be granted to the provider or supplier. While a short ERS may cause a provider or supplier to go out of business, the longer the ERS period the greater the delay in the overpayment recovery and the greater the financial risk to the Medicare program. We believe the increased risk associated with a longer repayment or amortization period requires that we give an ERS request greater financial scrutiny. *Comment:* We received comments that were outside the scope of the proposed rule (for example, regarding the effects on State Medicaid programs). *Response:* We are not responding in this final rule to comments that are outside of the scope of the proposed rule. IV. Provisions of the Final Regulations As a result of our review of the public comments, we do not find any cause to alter the provisions of the proposed rule. Therefore, we are finalizing the provisions as proposed. V. Collection of Information Requirements This final rule does not impose any new information collection or recordkeeping requirements. The information collection requirements discussed in the preamble pertain to the extension of repayment schedules. The requirements and associated paperwork burden are approved under Office of Management and Budget
(OMB)control number 0938-0270, with a current expiration date of January 31, 2011. We plan to submit a revised information collection request
(ICR)to OMB to address the reduction of burden associated with the “hardship test” and 6-month ERS period. As discussed in Section I. of the preamble, providers or suppliers that meet the “hardship” test and request only a 6-month ERS period, will have the opportunity to pay back the Medicare debt in 6 months without having to submit financial documentation to the contractor. This new requirement reduces the information collection burden placed on providers and suppliers. We will announce the revisions to 0938-0270 under separate notice and comment periods prior to submitting the revisions for OMB approval. VI. Regulatory Impact Statement A. Overall Impact We have examined the impacts of this 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), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)). Executive Order 12866 (as amended by Executive Order 13258 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 final rule will not reach the economic threshold and thus is not considered a major rule. There will be no additional costs or documented savings resulting from the implementation of this final rule. 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 hospitals 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 1 year. For purposes of the RFA, approximately 95 percent of the health care industry is considered small businesses according to the Small Business Administration's size standards with total revenues of $6.5 million to $31.5 million or less in any 1 year. Individuals and States are not included in the definition of a small entity. Because there are no additional costs or documented savings resulting from the implementation of this rule, the Secretary has determined that this final rule will not have a significant economic impact on a substantial number of small entities. 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 of a metropolitan statistical area and has fewer than 100 beds. Because there are no additional costs or documented savings resulting from the implementation of this final rule, this final 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 mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $127 million. This final rule will not impose spending costs on State, local, or tribal governments in the aggregate, or by the private sector, of $127 million. 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. This final rule will not have a substantial effect on State or local governments. B. Anticipated Effects 1. Effects on Medicare Providers and Suppliers This final rule could affect all Medicare provider and supplier types with a Medicare overpayment. This final rule will allow Medicare providers or suppliers falling within these provisions a 6 month period to pay back debt owed to Medicare without being required to file extensive financial documentation. We believe that this short repayment time period could provide a provider or supplier time to generate or secure the necessary capital to liquidate the debt without having to file the financial documentation required to secure a longer repayment schedule. 2. Effects on Other Providers There will be no effect on other providers. 3. Effects on the Medicare and Medicaid Programs There will be no additional costs or documented savings resulting from the implementation of this final rule. There may be savings due to a possible reduction in paperwork. C. Alternatives Considered We considered adopting mathematically precise distinctions between “hardship” and “extreme hardship,” but rejected this approach. To select any type of numerical threshold, for example, defining “extreme hardship” as 15 percent of total overpayments in an effort to distinguish it from the test for “hardship,” will result in inequitable outcomes for different providers and suppliers as discussed in the “extreme hardship” section in section II. of this final rule, Provisions of the Proposed Regulations. In implementing section 935(a) of the MMA, we want to assure providers and suppliers that we will be looking closely at the financial picture each of them has that has prompted them to seek an ERS. Analyzing these financial profiles is a complex undertaking that does not lend itself to overly simplified numerical cutoffs that may qualify some for longer repayment periods but deny them to others that ought to be just as eligible. We solicited comments on other alternative ways to distinguish between “hardship” and “extreme hardship” in an effort to establish a standardized approach to applying the two definitions. D. Conclusion In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects in 42 CFR Part 401 Claims, Freedom of information, Health facilities, Medicare, Privacy. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below: PART 401—GENERAL ADMINISTRATIVE REQUIREMENTS 1. The authority citation for part 401 is revised to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart F—Claims Collection and Compromise 2. In § 401.601, paragraph
(a)is revised to read as follows: § 401.601 Basis and scope.
(a)*Basis.* This subpart implements the following statutory provisions:
(1)For CMS the Debt Collection Improvement Act of 1996 (Pub. L. 104-134) (DCIA), 110 Stat. 1321, 1358 (April 26, 1996) (codified at 31 U.S.C. 3711), and conforms to the regulations (31 CFR parts 900-904) issued jointly by the Department of the Treasury and the Department of Justice that generally prescribe claims collection standards and procedures under the DCIA for the Federal government.
(2)Section 1893(f)(1) of the Act regarding the use of repayment plans. 3. In § 401.603, add a new definition for “Extended repayment schedule” to read as follows: § 401.603 Definitions. *Extended repayment schedule* means installment payments to pay back a debt. § 401.607 [Amended] 4. In § 401.607— A. Redesignate paragraph (c)(2) as paragraph (c)(3). B. Add a new paragraph (c)(2). The addition reads as follows: § 401.607 Claims collection.
(c)* * *
(2)*Extended repayment schedule.*
(i)For purposes of this paragraph (c)(2), the following definitions apply: *Extreme hardship* exists when a provider or supplier qualifies as being in “hardship” as defined in this paragraph and the provider's or supplier's request for an extended repayment schedule
(ERS)is approved under paragraph (c)(3) of this section. *Hardship* exists when the total amount of all outstanding overpayments (principal and interest) not included in an approved, existing repayment schedule is 10 percent or greater than the total Medicare payments made for the cost reporting period covered by the most recently submitted cost report for a provider filing a cost report, or for the previous calendar year for a supplier or non cost-report provider.
(ii)CMS or its contractor reviews a provider's or supplier's request for an ERS. For a provider or a supplier not paid by Medicare during the previous year or paid only during a portion of that year, the contractor or CMS will use the last 12 months of Medicare payments. If less than a 12-month payment history exists, the number of months available is annualized to equal an approximate yearly Medicare payment level for the provider or supplier.
(iii)For a provider or supplier requesting an ERS, CMS or its contractor evaluates the request based on the definitions and information submitted under this paragraph (c)(2). For a provider or supplier whose situation does not meet the definitions in paragraph (c)(2)(i) of this section, CMS or its contractor evaluates the ERS request using the information in paragraph (c)(3) of this section in deciding to grant an ERS.
(iv)CMS or its contractor is prohibited from granting an ERS to a provider or supplier if there is reason to suspect the provider or supplier may file for bankruptcy, cease to do business, discontinue participation in the Medicare program, or there is an indication of fraud or abuse committed against the Medicare program.
(v)CMS or its contractor may grant a provider or a supplier an ERS of at least 6 months if repaying an overpayment within 30 days will constitute a “hardship” as defined in paragraph (c)(2)(i) of this section. If a provider or supplier is granted an ERS under this paragraph, missing one installment payment constitutes a default and the total balance of the overpayment will be recovered immediately.
(vi)CMS or its contractor may grant a provider or a supplier an ERS of 36 months and up to 60 months if repaying an overpayment will constitute an “extreme hardship” as defined in paragraph (c)(2)(i) of this section. Authority: (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: *January 22, 2008.* Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: *February 27, 2008.* Michael O. Leavitt, Secretary. Editorial Note: This document was received at the Office of the Federal Register on June 11, 2008. [FR Doc. E8-13520 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 424, and 498 [CMS-6003-F] RIN 0938-AI49 Medicare Program; Appeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privileges AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule implements a number of regulatory provisions that are applicable to all providers and suppliers, including durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. This final rule establishes appeals processes for all providers and suppliers whose enrollment, reenrollment or revalidation application for Medicare billing privileges is denied and whose Medicare billing privileges are revoked. It also establishes timeframes for deciding enrollment appeals by an Administrative Law Judge
(ALJ)within the Department of Health and Human Services
(DHHS)or the Departmental Appeals Board (DAB), or Board, within the DHHS; and processing timeframes for CMS' Medicare fee-for-service
(FFS)contractors. In addition, this final rule allows Medicare FFS contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. This final rule also specifies that a Medicare contractor may establish a Medicare enrollment bar for any provider or supplier whose billing privileges have been revoked. Lastly, the final rule requires that all providers and suppliers receive Medicare payments by electronic funds transfer
(EFT)if the provider or supplier, is submitting an initial enrollment application to Medicare, changing their enrollment information, revalidating or re-enrolling in the Medicare program. DATES: *Effective Date:* These regulations are effective on August 26, 2008. FOR FURTHER INFORMATION CONTACT: August Nemec,
(410)786-0612. SUPPLEMENTARY INFORMATION: I. Background A Medicare beneficiary may obtain covered Medicare items or services from any person, or institution that is enrolled in the Medicare program and is qualified to furnish those services. Various provisions of the statute and regulations establish conditions of participation or standards that a healthcare provider or supplier must meet in order to receive Medicare payment. These standards differ depending on the type of provider or supplier involved and whether the services are furnished under Parts A or B of the Medicare statute. There are also differences in qualifications between providers and suppliers of services, and differences among the various types of suppliers, in how they are enrolled in the Medicare program. For some classifications of providers and suppliers, an on-site survey is required. For other individuals or entities, a determination can be made based largely on the information provided by the applicant. The Medicare regulations in 42 CFR part 498 provide appeal rights for providers and suppliers that have been found to not meet certain conditions of participation or established standards. For the purposes of part 498, these suppliers include, but are not limited to, independent laboratories; suppliers of portable x-ray services; rural health clinics; federally qualified health centers; ambulatory surgical centers; entities approved by CMS to furnish outpatient diabetes self-management training or end-stage renal disease treatment facilities. For the purposes of part 498, the term “provider” refers to a hospital, critical access hospital (CAH), skilled nursing facility, comprehensive outpatient rehabilitation facility (CORF), home health agency or hospice (HHA), religious nonmedical health care institutions (RNHCIs) that has in effect an agreement to participate in Medicare; or a clinic, rehabilitation agency, or public health agency that has in effect a similar agreement but only to furnish outpatient physical therapy or speech pathology services. In addition, § 405.874 provides an appeals process for suppliers of DMEPOS that wish to contest a denial of an application for billing privileges or the revocation of existing billing privileges. It also affords DMEPOS suppliers the right to a carrier or Medicare Administrative Contractor
(MAC)hearing before an official who was not involved in the original determination, and the right to seek a review before a CMS official designated by the CMS Administrator. In December 1998, we issued CMS Ruling 98-1, which outlined the appeals process that Medicare carriers must provide to physicians, nonphysician practitioners, and to certain entities that receive reassigned benefits from physicians and nonphysician practitioners. CMS Rulings are decisions of the Administrator that serve as precedent for final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of statute or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. CMS Rulings are binding on all our components, Medicare contractors, the Provider Reimbursement Review Board, the Medicare Geographic Classification Review Board, and ALJs who hear Medicare appeals. These Rulings promote consistency in interpretation of policy and adjudication of disputes. This final rule is different from the clarification of appeals procedures found in CMS Ruling 98-1, because it adds provisions in order to comply with the MMA. Whereas the ruling followed the procedures in § 405.874, this final rule would grant suppliers the right, after denial or revocation of a supplier's Medicare billing privileges, to a hearing by an ALJ after an adverse decision at the reconsideration level, as well as judicial review. In the October 25, 1999 **Federal Register** (64 FR 57431), we published a proposed rule Appeals of Carrier Terminations that a Supplier Fails to Meet the Requirements for Medicare Billing Privileges that would revise § 405.874 by extending appeal rights to all suppliers whose enrollment applications for Medicare billing privileges are disallowed by a carrier or whose Medicare billing privileges are revoked, except for those suppliers covered under existing appeals provisions of our regulations. Since we did not publish our earlier rulemaking effort within 3 years as required by section 902 of the MMA, we published a new proposed rule on March 2, 2007. This proposed rule included changes mandated by section 936(a) and
(b)of the MMA. II. Provisions of the March 2, 2007 Proposed Rule In the March 2, 2007 **Federal Register** (72 FR 9479), we published a proposed rule that set forth standard provider and supplier appeal procedures as established in section 936 of the MMA and proposed certain other provisions associated with Medicare's provider and supplier enrollment process. We proposed to maintain § 405.874, which specifies provisions that would apply to certain suppliers as defined in § 405.802. In § 405.802, we proposed to define prospective supplier and suppliers by specifying the provisions of § 405.874 that would apply. In § 405.874(a), we proposed that if a CMS contractor (that is, a carrier, fiscal intermediary or Medicare administrative contractor (MAC)) denies a supplier's enrollment application, the CMS contractor must notify the supplier by certified mail. The notice must include the following:
(1)The reason for the denial in sufficient detail to allow the supplier to understand the nature of its deficiencies;
(2)the right to appeal in accordance with part 498; and
(3)the address to which the written appeal must be mailed. In § 405.874(b)(1), we proposed to clarify that if a carrier revokes a supplier's Medicare billing privileges that the carrier must notify the supplier by certified mail and that the notice must include—(1) The reason for the revocation in sufficient detail for the supplier to understand the nature of its deficiencies;
(2)the right to appeal in accordance with part 498 of this chapter;
(3)the address to which the written appeal must be mailed. In § 405.874(b)(2), we proposed to separate the procedures in existing § 405.874(a) and § 405.874(b). In § 405.874(b)(2), we proposed clarifying that a revocation of a supplier billing privileges that is based on a Federal exclusion or debarment is effective with the effective date of the exclusion or debarment, regardless of the date of the notice from the carrier that the billing privileges are revoked. Moreover, if CMS, or one of its designated contractors revokes Medicare billing privileges, we would not revoke an individual or organization's National Provider Identifier (NPI). In § 405.874(b)(3), we proposed clarifying that suppliers are not paid for items or services furnished during a period in which a supplier does not have billing privileges or its billing privileges have been revoked. Concerning DMEPOS suppliers, section 1834(j)(1) of the Social Security Act (the Act) states that, with the exception of medical equipment and supplies furnished incident to a physician's service, no payment may be made by Medicare for items and supplies unless the supplier has active Medicare billing privileges. We further proposed that claims submitted to CMS contractors for items or services furnished during a period of supplier ineligibility are to be rejected by the CMS contractor, not denied. In § 405.874(c)(1), we proposed that a supplier's appeal rights would follow the processes detailed in part 498. In § 405.874(d), we proposed to revise this section to reflect that claims for services furnished to Medicare beneficiaries during a period in which the supplier's billing privileges were not effective are rejected and not denied. If a provider or supplier is determined not to have qualified for billing privileges in one period but qualified in another, contractors process claims for services furnished to beneficiaries during the period for which the provider or supplier was Medicare-qualified. Subpart C of this part sets forth the requirements for recovery of overpayments. The appeals process for denied claims should not apply if a provider or supplier does not have billing privileges. In § 405.874(d)(3), we proposed if a revocation of a provider's or supplier's billing privileges is reversed upon appeal, the provider's or supplier's billing privileges are reinstated back to the date that the revocation became effective. In § 405.874(d)(4), we proposed that if a denial of a provider's or supplier's billing privileges is reversed upon appeal, then the appeal decision establishes the date that the provider's or supplier's billing privileges will become effective. In § 405.874(e), we proposed that if a provider or supplier completes a corrective action plan and provides sufficient evidence to the CMS contractor that it has complied fully with Medicare requirements, the CMS contractor may reinstate the supplier's billing privileges. In § 405.874(f), we proposed revising the effective date for DMEPOS supplier's billing privileges. If a carrier, carrier hearing officer, or ALJ determines that a DMEPOS supplier's denied enrollment application meets the standards in § 424.57 of this chapter and any other requirements that may apply (for example, reinstatement after an OIG exclusion), the determination establishes the effective date of the billing privileges as not earlier than the date the CMS contractor made the determination to deny the supplier's enrollment application. Claims are rejected for services furnished before that effective date. In § 405.874(g), we proposed that a provider or supplier succeeding in having its enrollment application denial or billing privileges revocation reversed, or in having its billing privileges reinstated, may submit claims to the CMS contractor for services furnished during periods of Medicare qualification, subject to the limitations in § 424.44 of this chapter, regarding the timely filing of claims. In § 405.874(h), we proposed establishing deadlines for the adjudication of provider enrollment actions. We proposed that contractors adjudicate initial determinations and revalidations within 180 days of receipt and carriers adjudicate change-of-information and reassignment of payment request within 90 days of receipt. In addition, we proposed to establish timeframes for each administrative level of appeal. The following table identifies who makes the determinations and the associated timeframes in which each determination is made. Medicare provider enrollment determination Timeframe to file an appeal
(days)Proposed maximum adjudication timeframe
(days)Initial 60 180 Reconsideration 60 60 Administrative Law Judge Review 60 180 Departmental Appeals Board Review 60 180 Federal District Court N/A N/A In § 424.510(d)(2)(iv), we proposed that at the time of enrollment, an enrollment change request or revalidation, providers and suppliers shall submit the CMS-588 form to receive payments via electronic funds transfer. In § 424.545(a), we proposed the following: • Redesignating the first sentence of current paragraph
(a)as the introductory text and revising that text to remove the reference to part 405 subpart H. • Redesignating the second sentence of current paragraph
(a)as paragraph (a)(1)(i). • Adding paragraph (a)(1)(ii) to clarify that if a provider appeals both of these sanctions, then both matters will be resolved using a single appeals process. • Redesignating the last sentence of current paragraph
(a)as paragraph (a)(2). In § 424.525(a)(1) and (a)(2), we proposed potential reasons for rejecting enrollment applications by reducing the amount of time that a provider or supplier must furnish complete information requested by a contractor from 60 to 30 days. Additionally, we proposed a reduction from 60 to 30 days for the period allowed to furnish all supporting documentation for submitting their enrollment application. We proposed rejecting an application that is submitted by a provider or supplier if it is incomplete or if it fails to include all required supporting documentation on the enrollment application within 30 days of receipt. In § 424.535(a)(8), we proposed allowing Medicare FFS contractors, under the direction of CMS, to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. In § 424.535(b)(2), we proposed a timeframe to wait for reapplication to the Medicare program when a provider or supplier is revoked. Specifically, we proposed that when a provider or supplier, including all authorized officials, delegating officials and practitioners, is revoked for any of the reasons listed at § 424.535 that the provider, supplier, delegated official or authorizing official be prohibited from enrolling for 3 years. In § 498.1(g), we proposed to establish an ALJ hearing, and judicial review for any provider or supplier whose application for enrollment or reenrollment in Medicare has been denied. In § 498.2, we proposed revising the definition of a “supplier” to—(1) Include a supplier of DMEPOS; ambulance service provider; independent diagnostic testing facility; physician; and other practitioner such as physician assistant; and
(2)remove the reference to “prospective supplier.” In § 498.2, we proposed adding a new definition for “prospective supplier.” We also proposed removing the definition of the “Office of Hearings and Appeals (OHA)” because the function of this office has been moved from the Social Security Administration to the DHHS. We also proposed to revise the definition of “affected party” to specify that it includes CMS or a CMS contractor. In § 498.5, we proposed revising this section by adding a new paragraph
(l)that would be used to clarify the administrative process that a prospective provider, existing provider, prospective supplier or existing supplier dissatisfied with an initial determination or revised initial determination related to the denial or revocation of Medicare billing privileges. We proposed revising § 498.5(f)(2) to be consistent with the change in § 498.1(g). This would implement the mandate of section 936(a)(2) of the MMA regarding judicial review. We proposed these standards because the FFS contractors need sufficient time to adjudicate the facts and make a reasoned decision. Moreover, while we are establishing an outside limit for processing these applications, the vast majority of these decisions are made within 120 days. We proposed revising § 498.22(a) to add that we have delegated authority to our contractors to reconsider an initial determination. We also proposed revising § 498.22(b)(1) to state that a reconsideration request is to be filed with CMS or with the State survey agency, or, in the case of prospective suppliers, the entity specified in the notice of initial determination. We proposed revising § 498.44 to remove the term Associate Commissioner for Hearings and Appeals, and we replaced it with the Secretary, because this function is no longer under the Social Security Administration; it is now under the Department of Health and Human Services. In § 405.874(c)(2), we proposed clarifying that a provider or supplier is required to prove that it is in compliance with all Medicare requirements for billing privileges, and that the Medicare FFS contractor incorrectly denied or revoked the supplier's billing privileges. In § 498.56, we proposed adding a new paragraph
(e)that specifies the “good cause” exception to the admission of new evidence at the ALJ and DAB appeal levels. Accordingly, we proposed revising § 498.56 and § 498.86 to prohibit providers and suppliers from submitting new provider enrollment issues or evidence at the ALJ and DAB levels of review. In § 498.78(a), we proposed to delete the provision that an affected party concur in writing or on the record with a CMS or Department of Health and Human Services Office of Inspector General
(OIG)request for remand. We believe that the appeals process can be enhanced by allowing an ALJ to remand a provider enrollment case to the Medicare FFS contractor when CMS requests a remand. Further, we believe that a remand request could result in either a favorable decision to the appellant or an administrative record that is complete. In § 498.79, we proposed that an ALJ must issue a decision, dismissal order or remand to CMS, as appropriate, no later than 180 days after the initial request for a hearing. Finally, in § 498.88(g), we proposed that the Board must issue a decision, dismissal order or remand to the ALJ, as appropriate, no later than 180 days after the appeal was received by the Board. III. Analysis of and Responses to Public Comments We received approximately 30 comments in response to the March 2, 2007 proposed rule. The following is a summary of the comments received and our responses. *Comment:* Several commenters recommended that we clarify whether the provisions of the proposed rule apply to all providers and suppliers. *Response:* The provisions of the proposed and this final rule apply to all the providers and suppliers described in the § 405.802 or § 498.2. Therefore, in response to comments received, we are adding definitions for “prospective supplier” and “prospective provider” to § 405.802 and § 498.2. Since applicants (prospective provider and suppliers) who are not enrolled in the Medicare program still are afforded appeal rights based on an enrollment denial, we maintain that it is important to clarify that any prospective applicant (provider or supplier) is afforded appeal rights through this process. *Comment:* One commenter recommended that we separately define “prospective provider” and modify the definition of provider accordingly. *Response:* We agree with the commenter's recommendations and have included a definition of “prospective provider” in § 405.802 and 498.2 and have revised the definition of “provider” at § 405.802 and § 498.2. *Comment:* One commenter suggested that we change the definition of supplier to include occupational therapists in private practice. *Response:* This comment falls outside the scope of the proposed rule. Therefore, we believe it would be inappropriate for us to address this comment in this final rule. *Comment:* Several commenters recommended that we clarify whether a provider or supplier who uses a corrective action plan
(CAP)is precluded from also appealing the contractor, carrier, MAC, or FI decision. *Response:* A CAP is the plan that allows a provider or supplier an opportunity to correct deficiencies (if possible) that resulted in a denial or revocation of billing privileges. The CAP should provide evidence that the provider or supplier is in compliance with Medicare enrollment requirements. A provider or supplier that uses a CAP is not precluded from also appealing the FFS contractor's (that is in a MAC, FI, or carrier) decision. The Medicare FFS contractor, including the National Supplier Clearinghouse (NSC), will accept the submission of a corrective action plan for revoked billing privileges if the corrective action plan is submitted within 15 days from the date of the notice for DMEPOS suppliers or within 30 days from the date of the notice for all other providers and suppliers. *Comment:* Several commenters recommended that we clarify that an independent contractor hearing officer will conduct the reconsideration of an adverse enrollment decision. *Response:* For the purpose of this final rule, the term an independent contractor hearing officer means that a reconsideration will be handled by a hearing officer not involved in the initial determination. We believe this will ensure that the appellant receives a fair and impartial reconsideration. It is also important to note that while the claims appeals process uses a “qualified independent contractor” to conduct reviews, the provider enrollment appeals process does not use a “qualified independent contractor.” *Comment:* Several commenters recommended that we clarify when a provider or supplier may resubmit a new initial enrollment application after an enrollment denial. *Response:* Since the denial of enrollment application conveys appeal rights, a provider or supplier cannot resubmit a new initial enrollment application until after the 60 day appeal period has ended. This will ensure that the Medicare contractor is not processing an initial application during the timely filing period of an appeal. In addition, if a provider or supplier submits a new initial enrollment application during the timely appeals filing period, the Medicare contractor will return the application to the applicant. *Comment:* One commenter recommended that we change our proposed language concerning a remand by an ALJ to specify that CMS does not have authority to request a remand when the Agency is also a party to an ALJ proceeding. *Response:* We believe that we should have all the rights afforded to an appellant. Further, by allowing CMS to request a remand, we believe that the designated contractor or CMS Regional Office will be able to review or re-examine the administrative record to update or provide documentation to establish a complete administrative record. By doing so, we believe higher levels of appeal will have the information needed to effectuate a timely decision. Therefore, we do not agree with the commenter's recommendation to revise the language to prohibit our authority to request a remand. *Comment:* One commenter recommended that we adopt a 45-day time period for adjudication of ALJ and DAB decisions. *Response:* We believe that a 45-day time period is not practical. While we understand the desire to establish an efficient appeals process, we are adopting similar time frames as had been established for deciding a claims appeal before an ALJ or DAB (see § 405.1016(c)). As stated previously, the early presentation of evidence will allow the contractor hearing officer or the CMS Regional Office to make decisions using all relevant facts as applied to the appeal. In doing so, the hearing officer or regional office will issue their findings to establish a complete administrative record for the future appeal levels. We believe that a complete administrative record will help facilitate decision making at higher levels of appeal. *Comment:* Several commenters stated that a reconsideration is an unnecessary delay in the appeals process, and that applicants should be able to appeal directly to an ALJ. *Response:* We determined that the most effective way to implement the requirements of section 936(j)(2) of the MMA was to amend the existing appeals procedures in part 498. The appeals procedures under part 498 include reconsideration as a level of review before an appeal is made to an ALJ. We believe that the reconsideration level provides an additional opportunity for the matter to be resolved prior to the filing of an appeal to an ALJ. *Comment:* One commenter requested clarification of § 405.874(c)(2), which discussed the reconsideration of a determination to deny or revoke a provider or supplier's Medicare billing privileges. *Response:* The reconsideration of a determination to deny or revoke a provider or supplier's Medicare billing privileges will be handled by a carrier hearing officer not involved in the initial determination or a CMS Regional Office for a Part A determination. There are distinct appeals provisions for claims processing and provider enrollment. While the claims process uses claims determination and qualified independent contractors
(QICs)as part of the appeals process, the provider enrollment process does not. The first level of appeal of adverse actions is to either a contractor hearing officer for noncertified suppliers or to the CMS Regional Office for certified providers or suppliers. Subsequently, appellants may appeal adverse provider enrollment determinations by a hearing officer or regional office to an ALJ, then the DAB, and then to Federal District Court. *Comment:* One commenter recommended that § 498.86(a) concerning evidence admissible on review by the DAB, adopt and follow the good cause exception set forth in proposed § 498.56(e) for ALJ proceedings. *Response:* By the time the DAB hears the provider enrollment appeal, the applicant has been afforded ample opportunity to submit any evidence germane to the adverse determination. Accordingly, we do not believe it is efficient or administratively effective to establish a “good cause” provision within the language at § 498.86(a). *Comment:* While we received a number of comments supporting our proposal to prohibit providers and suppliers from submitting new evidence during the ALJ and DAB levels of appeal, several commenters stated they were opposed to this proposal. *Response:* Consistent with the provisions of our April 21, 2006 final rule titled “Requirements for Establishing and Maintaining Medicare Billing Privileges and Provider Enrollment Process” (71 FR 20754), we believe all providers and suppliers must meet and maintain all Federal and State requirements for their provider or supplier type to enroll or maintain their enrollment in the Medicare Program. When a Medicare contractor makes an adverse enrollment determination (for example, enrollment denial or revocation of billing privileges), providers and suppliers are afforded appeal rights. However, these appeal rights are limited to provider or supplier eligibility at the time the Medicare contractor made the adverse determination. Thus, if a Medicare contractor determines that a provider or supplier does not meet State licensure requirements on June 1, 2007, it is the provider's responsibility to demonstrate during the appeals process that State licensure requirements were met on June 1, 2007. Conversely, if a provider only can demonstrate that State licensure requirements were met on a later date; such as, August 16, 2007, we believe that the contractor made the correct determination, and that the provider or supplier may reapply for Medicare billing privileges. Accordingly, a provider or supplier is required to furnish the evidence that demonstrates that the Medicare contractor made an error at the time an adverse determination was made, not that the provider or supplier is now in compliance. Thus, we believe that it is essential that providers and suppliers submit documentation that supports their eligibility to participate in the Medicare program during the reconsideration step of the provider enrollment appeals process. This will allow a hearing officer to review and make a decision using all applicable facts. Moreover, the early presentation of evidence will help to ensure an efficient and effective administrative appeals process. Finally, in order to expedite the provider enrollment appeals process, we believe that applicants must present all relevant facts and supporting documentation prior to or during the first level of appeal (that is, reconsideration). This will enable a contractor hearing officer or the CMS Regional Office personnel to review and make a determination based on all available facts. Moreover, the early presentation of facts and supporting documentation can be used to build the administrative record and help facilitate timely decisions at higher levels of appeals. *Comment:* One commenter suggested that we continue to follow the existing ALJ and DAB procedures in part 498 to allow for consideration and for submission of additional evidence related to a provider or supplier enrollment appeal after the initial information is submitted. *Response:* As stated previously in this final rule, in order to expedite the provider enrollment appeals process, we believe that applicants must present all relevant facts and supporting documentation prior to or during the first level of appeal (that is, reconsideration). This will enable a contractor hearing officer or the CMS Regional Office personnel to review and make a determination based on all available facts. Moreover, the early presentation of facts and supporting documentation can be used to build the administrative record and help facilitate timely decisions at higher levels of appeals. *Comment:* Several commenters stated that we used the terms “billing number” and “billing privileges” interchangeably in the proposed rule and that caused confusion. *Response:* We appreciate these comments and will revise the final rule to use the term “billing privileges” throughout. With the implementation of the National Provider Identifier on May 23, 2008, Medicare will no longer issue a billing number to providers and suppliers, but will, in fact, convey billing privileges to a provider or supplier if they meet and maintain all Federal and/or State requirements to enroll or remain enrolled in the Medicare program. *Comment:* Several commenters recommended that physicians be allowed to appeal rejected claims once Medicare billing privileges are granted. *Response:* Physicians, as well as providers and other suppliers, are required to enroll in the Medicare program before submitting a Medicare claim. Accordingly, if a claim is rejected because the physician is not enrolled, a physician must resubmit the claims after he or she is enrolled in the Medicare program in compliance with Medicare's provision for timely filing (§ 424.44). *Comment:* One commenter recommended that we not require the submission of the Electronic Funds Transfer Authorization Agreement
(EFT)form (CMS-588) if a provider or supplier is already receiving payments electronically. *Response:* We agree with this commenter. We believe an enrolled provider or supplier who is already receiving Medicare payments electronically is not required to submit the CMS-588 with a change in enrollment unless the provider or supplier is seeking to change its depository information. *Comment:* Several commenters recommended that we address concerns regarding operational issues associated with the requirement to obtain payments electronically. Specifically, these commenters recommended that we address in this final rule the practice of reversing entry procedures where we may overpay the provider or supplier and then later reclaim that overpayment. *Response:* We appreciate this comment and understand this concern; however, this issue is outside the scope of the proposed rule. *Comment:* Several commenters stated that the provisions of this rule eliminated a physician's right to retroactively bill for services as is the current practice for some physicians. *Response:* This rule did not propose a change in the current provisions regarding retroactive billing; therefore, we believe this comment is outside the scope of the proposed rule. *Comment:* Several commenters supported our proposal to reduce from 60 to 30 days for information required to process an enrollment application, and they wanted to know if they could retroactively apply the provision to pending inventories. *Response:* We appreciate the support for our proposal to reduce the time allotted to produce the necessary documentation to process enrollment applications from 60 days to 30 days before allowing a contractor to reject an enrollment application. However, we will prohibit our contractors from retroactively applying this change to pending inventories. Accordingly, any applications received after the effective date of this final rule will be subject to its provisions. *Comment:* Several commenters recommended that we not reduce the amount of time providers or suppliers have to respond to a request from Medicare FFS contractor, (that is, carrier, FI, or MAC) for additional information from 60 days to 30 days as proposed in § 425.525(a)(2). *Response:* We continue to believe that it is essential that providers and suppliers submit a complete application, including all supporting documentation, at the time of filing or at a minimum, respond to a contractor's request for information in a timely manner. Accordingly, absent the submission of a complete application, we believe that it is appropriate that providers and suppliers respond to a contractor's request for additional information in a timely manner. We believe that allowing a provider or supplier 30 days is more than enough time to obtain and submit the requested information or documentation. Finally, we believe that this change will lead to processing efficiencies for not only the Medicare program but also for those providers and suppliers who seek to enroll or make a change in their existing Medicare enrollment information. *Comment:* One commenter requested that we clarify our requirement for furnishing requested enrollment documentation with respect to the 30-day timeframe before the rejection of an enrollment application. *Response:* We believe that a contractor may reject the provider or supplier's enrollment application if the provider or supplier fails to respond to a request for information in a complete and timely manner (that is, within 30 days of the contractor request for additional information.) For example, assume that an applicant submits an enrollment application on May 1, 2008. While processing the enrollment application the contractor determines that the applicant did not complete section 3 of the application and did not submit the required supporting documentation to receive payments electronically. On May 16, 2008, the contractor notifies the applicant about the missing documentation. Assuming that the applicant does not submit all requested information by June 15, 2008 (that is, 30 days from the contractor request), the contractor may reject the application. *Comment:* Several commenters stated that the proposed enrollment application processing timeframes stated in proposed § 405.874(h) were too long and would inhibit suppliers from enrolling or re-enrolling in the Medicare Program. *Response:* We are also concerned about delays associated with the enrollment process. However, we recognize that many of the delays are the result of providers and suppliers not submitting a complete application at the time of filing or failing to submit complete and timely responses to a contractor's request for information. In addition, we believe that it is appropriate to establish meaningful Medicare contractor processing timeliness standards and, as necessary, update or revise processing standards through the manual instructions and through contracts with Medicare contractors. Finally, while this final rule establishes an outer boundary for processing enrollment application, we fully expect that most enrollment applications will be processed in accordance with CMS processing requirements found in Publication 100-8, Chapter 10 of the Program Integrity Manual (PIM). The PIM establishes processing standards for initial applications, changes of information, and reassignments that all Medicare contractors must follow. Specifically, we currently require Medicare contractors to process 80 percent of initial applications within 60 days, 90 percent of initial applications within 120 days, and 99 percent of initial applications within 180 days. We also require Medicare contractors to process 80 percent of changes of information and reassignments within 45 days, 90 percent of changes of information and reassignments within 60 days and 99 percent of such applications within 90 calendar days of receipt. With the implementation of the Provider Enrollment, Chain and Ownership System (PECOS) Web, an Internet version of the Medicare enrollment process, in FY 2008, we have established more stringent contractor processing timeliness standards for applications for enrollment submitted via PECOS Web. On January 4, 2008, we revised the processing requirements in Publication 100-8, Section 2, Chapter 10 of the PIM to establish the following processing requirements for PECOS Web applications: Specifically, we will require Medicare contractors to process 90 percent of initial applications within 45 days, 95 percent of initial applications within 60 days, and 99 percent of initial applications within 90 days. We also require Medicare contractors to process 80 percent of changes of information and reassignments within 45 days, 90 percent of changes of information and reassignments within 60 days and 99 percent of such applications within 90 calendar days of receipt. Since PECOS Web will improve the accuracy of applications submitted to contractors and reduce the time necessary to receive, verify and make a final determination regarding an enrollment action, we believe that the public should benefit from these processing efficiencies. Accordingly, we maintain that establishing a separate processing time standard for applications submitted via PECOS Web is appropriate. *Comment:* Several commenters raised concerns as to whether we will be changing the processing standards to non-tiered percentages for processing initial applications (including revalidations), as well as with regard to changes of information (including reassignments not submitted in conjunction with an initial enrollment package). *Response:* While we will maintain a tiered system we are establishing an outer boundary for the number of days for processing Medicare enrollment applications in this final rule, we will maintain more specific processing standards in Chapter 10 of the PIM. *Comment:* One commenter asked if the proposed regulation will change the processing standard found in Section 2 of Chapter 10 of the PIM. *Response:* This final rule does not change the provider enrollment processing standards found in Section 2 of Chapter 10 of the PIM. *Comment:* One commenter agreed with the 30-day timeframe for submitting supporting information as long as our contractors are required to follow this same timeframe for processing enrollment applications. *Response:* While we are proposing an outside limit of 180 days for processing applications, we have established shorter processing timeframes in manual guidance which must be adhered to by CMS contractors. However, we believe that 30 days does not provide contractors with sufficient time to process all enrollment applications. While we believe in holding contractors responsible for meeting our defined processing standards, it is essential that providers and suppliers submit a complete application at the time of filing in order to lessen processing timeframes. *Comment:* One commenter asked for clarifications as to whether the 90-day timeframe requirement for change of information and reassignment of payment requests submitted applies to both fiscal intermediaries, as well as carriers. *Response:* The 90-day processing standard applies to changes in information submitted to a fiscal intermediary/MAC or a change of information or reassignment submitted to a carrier/MAC. Therefore, § 405.874(h)(3) applies to both providers and suppliers. We note that DMEPOS suppliers are required to submit changes in information to the NSC within 30 days of the changes as specified in § 424.57(c)(2). *Comment:* One commenter recommended that we allow academic medical centers to submit enrollment applications at least 6 months in advance of a physician's start date. *Response:* By submitting a complete enrollment application and all supporting documentation at the time of filing, a physician can efficiently enroll in the Medicare program. Additionally, with the implementation of PECOS Web, we believe that physicians will be able to enroll in a more efficient manner. Finally, since we require our contractors to verify the information provided in the enrollment application, and this cannot be accomplished if the physician is not yet working at the academic medical center, we are not able to adopt this recommendation. *Comment:* One commenter suggested that the 180-day processing time for enrollment decisions was not workable for providers undergoing a change of ownership
(CHOW)as specified in § 489.18. *Response:* Since Medicare contractors can only process applications that are complete at the time of filing and have the necessary supporting documentation, it is essential that CHOWs are complete when submitted. When completed applications are submitted, Medicare contractors will encounter fewer obstacles in processing an application. While we are establishing an outside processing timeframe in this rule, we have established more stringent processing requirements in the manual. We recognize the importance of processing CHOWs in a timely manner and will continue to establish processing standards in the manual which seek to ensure continuity of payment. *Comment:* While several commenters offered support for our proposal in § 424.535 to preclude provider or supplier billing for a period of 3 years after Medicare billing privileges are revoked, several commenters stated that a 3-year ban is too long. *Response:* We agree that Medicare contractors should consider the reason associated with revocation before determining whether the contractor should establish a re-enrollment bar for a provider or supplier. The goal of the re-enrollment bar is to ensure that Medicare billing privileges are given to trustworthy providers and suppliers. Consequently, if a Medicare contractor determines that a provider's or supplier's Medicare billing privileges should be revoked, then we believe that establishing an enrollment bar is appropriate. We will provide contractors with guidance on the establishment of an enrollment bar via manual instructions. With this guidance, we believe that the contractor has discretion to establish a re-enrollment bar from 1 to 3 years depending on the severity of the basis for revocation. For example, failure to respond to revalidation request may warrant a 1-year ban whereas failure to report an adverse legal action that could preclude payment would warrant a 3-year ban. In addition, if a contractor makes a decision to revoke Medicare billing privileges, we believe that the duration of the re-enrollment bar should not be less than 1 year. Finally, while we believe that providers and suppliers can appeal the revocation determination, we do not believe that providers and suppliers can appeal the duration of the re-enrollment bar for Medicare billing privilege. We also believe that providers and suppliers have an obligation to maintain their billing privileges and to report changes that would preclude enrollment or continued enrollment in accordance with § 410.33(g), § 424.57(c)(2), and § 424.520(b). In addition, we believe that establishing a re-enrollment bar for Medicare billing privileges that have been revoked will help protect the Medicare Trust Funds, and beneficiaries from potentially unqualified providers and suppliers. *Comment:* One commenter stated that the 3-year waiting period in proposed § 424.502 was a punitive action and is not within our legal authority, and that only the OIG has been granted legal authority to exclude individuals and entities from the Medicare program. *Response:* We believe that we have the obligation to protect the Medicare Trust Funds when billing privileges are revoked. We believe providers and suppliers whose billing privileges are revoked should be prevented from immediately re-entering the program. Accordingly, we believe that establishing a re-enrollment bar is appropriate and within our authority. Unlike OIG exclusions which apply government-wide and which generally last for 5 years or longer, the re-enrollment bar only applies to those billing the Medicare program. *Comment:* Several commenters recommended that we do not revoke a physician's billing privileges for 3 years because the physician did not respond to a revalidation request. *Response:* In the April 21, 2006 final rule, providers and suppliers learned about our intent to begin a revalidation process. Specifically, § 424.515 states that a provider or supplier (other than a DMEPOS supplier), must resubmit and recertify the accuracy of its enrollment information every 5 years. Therefore, providers and suppliers that enrolled in the Medicare program prior to 2003, but who have not completed a Medicare enrollment application since then, have had more than 2 years to come into voluntary compliance with our enrollment criteria by submitting a complete enrollment application. With this final rule, we are again notifying physicians, providers, and suppliers that they may voluntarily complete and submit a Medicare enrollment application and the necessary supporting documentation prior to our formal request for revalidation. Accordingly, providers and suppliers who choose not to come into voluntary compliance or fail to respond to a revalidation request in a complete and timely manner fail to satisfy our enrollment criteria and may be subject to revocation of their billing privileges. *Comment:* Several commenters recommended that we allow providers and suppliers to participate in the Medicare program if their revocation is successfully overturned at a higher level of appeal. *Response:* Section 405.874(d)(3) states a provider or supplier's billing privileges will be reinstated back to the date that their revocation became effective if it was reversed at a higher level of appeal. *Comment:* Several commenters recommended that we clarify that the period of provider or supplier ineligibility be linked to the date on which the supplier had provided a service to a beneficiary and not the date that a claim would be received or processed by a carrier. *Response:* We are clarifying that this is our intent. Revocation actions concerning provider and supplier ineligibility are based upon the date on which the provider or supplier had furnished a service to a beneficiary and not the date that a claim was received or processed by a carrier or MAC. For example, if a provider submits a claim for services provided on June 22, 2007, and the beneficiary dies on June 23, 2007, but the claim for the June 22, 2007 services was not received until August 1, 2007, if any action is taken regarding this claim, it would be with regard to the June 22, 2007 date. *Comment:* One commenter suggested that there are several instances where the date of service being billed could actually be the day after the date of death and that an honest billing of the service could be perceived as fraud, and therefore cause a provider or supplier to be incorrectly revoked. *Response:* We understand that there are certain situations when the date of service may legitimately be the day after the date of death of the beneficiary. Accordingly, Medicare contractors and CMS will review the specific details associated with each claim before taking any revocation action. *Comment:* We received several comments regarding implementation of the proposed changes to be set forth at § 424.535(a)(8) which allows Medicare contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary, where the commenter believed there was not enough guidance given to the contractors to filter these claims which could cause overburdened contractors to implement this policy too widely. *Response:* CMS, not a Medicare contractor, will make the determination for revocation under the authority at § 424.535(a)(8). We will direct contractors to use this basis of revocation after identifying providers or suppliers that have these billing issues. We have found numerous examples of situations where a physician claims to have furnished a service to a beneficiary more than a month after their recorded death, or when the provider or supplier was out of State when the supposed services had been furnished. In these instances, the provider has billed the Medicare program for services which were not provided and has submitted Medicare claims for service to a beneficiary who could not have received the service which was billed. This revocation authority is not intended to be used for isolated occurrences or accidental billing errors. Rather, this basis for revocation is directed at providers and suppliers who are engaging in a pattern of improper billing. In making a revocation determination under § 424.535(a)(8), we will make the revocation determination based upon information presented by a Medicare contractor, a CMS Regional Office, or one of our Program Integrity field offices. We believe that it is both appropriate and necessary that we have the ability to revoke billing privileges when services could not have been furnished by a provider or supplier. We recognize the impact that this revocation has, and a revocation will not be issued unless sufficient evidence demonstrates abusive billing patterns. Accordingly, we will not revoke billing privileges under § 424.535(a)(8) unless there are multiple instances, at least three, where abusive billing practices have taken place. Furthermore, providers and suppliers may appeal a contractor revocation using the process outlined in part 498 if they believe that they were unduly revoked. In conclusion, we believe that providers and suppliers are responsible for the claims they submit or the claims submitted on their behalf. We believe that it is essential that providers and suppliers take the necessary steps to ensure they are billing appropriately for services furnished to Medicare beneficiaries. *Comment:* Several commenters believed that contractors would be issuing revocations based upon the submission of claims for services that could not be delivered. *Response:* As stated above, we will instruct Medicare contractors to issue a revocation under § 424.535(a)(8). *Comment:* One commenter suggested several procedural changes regarding the processing of enrollment applications; such as, withdrawing an application and reopening a closed enrollment decision, be included in this regulation as opposed to our original procedural proposals. *Response:* As outlined in § 424.510, the current enrollment application procedures allow providers and suppliers a clear means to complete and submit enrollment applications with the necessary documentation to participate in the Medicare program. Prospective providers or suppliers are responsible for obtaining the necessary documentation that demonstrates that they meet the program requirements for their provider or supplier type. If a provider or supplier cannot supply the necessary documentation at the time of filing or in response to a contractor request, then the contractor is required to reject their application and the prospective provider or supplier must begin the enrollment process anew. Finally, a prospective provider or supplier may withdraw their Medicare enrollment application at any time by informing the designated contractor in writing of the withdrawal of the application. A withdrawal request must be made by the applicant or the Authorized Official as defined in § 424.502 and in the Medicare enrollment application (CMS-855). Unlike the claims appeals process where minor errors and omissions can be resolved though the reopening process in an effective and efficient manner, the issues involved in Provider Enrollment denials and revocations do not readily lend themselves to the reopening process. Accordingly, we have not adopted a reopening procedure in this final rule. *Comment:* One commenter recommended that we revise our 2002 “Do Not Forward” policy because of the change in processing timeframes for enrollment applications. *Response:* We believe this issue is outside the scope of the proposed rule and can not be addressed in this final rule. *Comment:* One commenter recommended that if we make a change in the Medicare enrollment application that we use the processing guidelines in effect at the time of the postmark date so that the application will be treated as submitted prior to the implementation date. *Response:* If we make a change in the Medicare enrollment application in the future, we will establish a transition period between the use of the prior version of the application and the new version of the application. *Comment:* One commenter stated that electronic funds transfer
(EFT)should be developed in concert with the CMS-855 transaction standard to ensure that there is a clear connection between the two files. *Response:* We believe this issue is outside the scope of the proposed rule and can not be addressed in this final rule. *Comment:* One commenter urged us to clarify that the reassignment exception still exists with regard to EFT which currently exempts individuals reassigning their benefits to a group practice from the EFT requirement. *Response:* Individuals reassigning all of their benefits to a group practice are still exempt from the EFT requirement. We will update its manuals to state that only individuals and organizations receiving payments directly must receive them through EFT. *Comment:* One commenter suggested that we consult with hospital-based faculty practices to determine the best way to implement EFT in this particular setting. *Response:* We will continue to conduct outreach efforts to ensure that all providers and suppliers are informed about EFT policies. *Comment:* One commenter recommended that adequate notification and education be provided to all who have chosen or are required to accept funds via EFT. *Response:* We will continue to conduct outreach efforts to ensure that all providers and suppliers are informed about EFT policies. We believe this issue is outside the scope of the proposed rule and can not be addressed in this final rule. *Comment:* One commenter recommended that notice of precertification completion be provided to group practices prior to the payment of funds via EFT. *Response:* We believe this issue is outside the scope of the proposed rule and can not be addressed in this final rule. *Comment:* One commenter stated we should not terminate a provider agreement when billing privileges are revoked. *Response:* In the April 21, 2006 final rule, we stated in § 424.545(a) that the termination of both the provider agreement and billing privileges will happen concurrently. Accordingly, we believe that a provider cannot retain a provider agreement if its billing privileges have been revoked. *Comment:* One commenter suggested that we amend the definition of supplier because they believed that the term ambulance service provider may not include suppliers of ambulance services. *Response:* While we are not adopting this recommendation, we clarify in section IV. of this final rule (Provisions of the Final Regulation) that an ambulance service provider includes all providers and suppliers of ambulance services. *Comment:* One commenter recommended that we conduct increased outreach and education efforts for providers, suppliers and contractor enrollment staff. *Response:* We will undertake the necessary steps to ensure that our contractors understand these new provisions and apply them consistently. In addition to publishing this final rule, we will issue operational guidance to our Medicare contractors. IV. Provisions of the Final Regulation Based on public comments, we are adopting the provisions of the proposed rule as final with the following changes: We are amending the provisions of this final rule to apply to all providers and suppliers, including DMEPOS suppliers. In § 405.802, we have added a definition of prospective provider. In § 405.874(a), we amended the proposed language and adopted the provision that if a carrier, fiscal intermediary, National Supplier Clearinghouse
(NSC)or MAC denies a provider's or supplier's enrollment application, then the carrier, fiscal intermediary, NSC or MAC must notify the provider or supplier by mail. The notice must include the following:
(1)The reason for denial in sufficient detail to allow the provider or supplier to understand the nature of its deficiencies;
(2)the right to appeal in accordance with part 498; and
(3)the address to which the written appeal must be mailed. In § 405.874(b)(1), we adopted the provision which clarified that if CMS or a CMS contractor, (that is, a carrier, fiscal intermediary, NSC or MAC) revokes a provider's or supplier's Medicare billing privileges, then CMS or its contractor must notify the provider or supplier by mail and that the notice must include—(1) The reason for the revocation in sufficient detail for the provider or supplier to understand the nature of its deficiencies;
(2)the right to appeal in accordance with part 498 of this chapter;
(3)the address to which the written appeal must be mailed. In § 405.874(b)(2), we adopted the provision to separate the procedures in existing § 405.874(a) and § 405.874(b). In addition, we adopted the provision clarifying that a revocation of provider's or supplier's billing privileges that is based on a Federal exclusion or debarment is effective with the effective date of the exclusion or debarment. Moreover, if CMS or a CMS contractor revokes Medicare billing privileges, then we would not revoke an individual or organization's National Provider Identifier (NPI). In § 405.874(b)(3), we modified our proposed provision to clarify that providers and suppliers are not paid for items or services furnished after the effective date of revocation. We removed proposed § 405.874(b)(3)(i) because it was not applicable to revocation of billing privileges. Concerning DMEPOS suppliers, section 1834(j)(1) of the Act states that, with the exception of medical equipment and supplies furnished incident to a physician's service, no payment may be made by Medicare for items and supplies unless the supplier has active Medicare billing privileges. We also adopted the provision that claims submitted to carriers, fiscal intermediaries, NSC or MACs for items or services furnished during a period of provider or supplier ineligibility are to be rejected by the carrier or fiscal intermediary and not denied. In § 405.874(c)(1), we adopted the provision that a provider's or supplier's appeal rights would follow the processes detailed in part 498. Generally denials or revocations issued by a fiscal intermediary would be handled by a CMS regional office (RO), and denials and revocations by carriers, including the NSC, would be handled by a carrier hearing officer. In those cases where a MAC issues a denial or revocation, the reconsideration would be handled by the CMS RO or a contractor hearing officer depending upon the provider or supplier type. The CMS RO's will generally be handling the Medicare Part A reconsiderations and the contractor hearing officer will generally be handling the Medicare Part B reconsiderations. In § 405.874(d), we adopted the revisions to this section to reflect that claims for services furnished to Medicare beneficiaries during a period in which the provider's or supplier's billing privileges were not effective are rejected and not denied. If a provider or supplier is determined not to have qualified for billing privileges in one period but qualified in another, contractors process claims for services furnished to beneficiaries during the period for which the provider or supplier was Medicare-qualified. Subpart C of this part sets forth the requirements for the recovery of overpayments. The appeals process for denied claims should not apply if a provider or supplier does not have billing privileges. In § 405.874(d)(3), we adopted the provision that when revocation of a provider's or supplier's billing privileges are reversed upon appeal, the provider's or supplier's billing privileges are reinstated back to the date that the revocation became effective. In § 405.874(d)(4), we adopted the provision that if a denial of a provider's or supplier's billing privileges is reversed upon appeal, then the appeal decision establishes the date that the provider's or supplier's billing privileges will become effective. In § 405.874(e), we adopted the provision that if a provider or supplier completes a corrective action plan and provides sufficient evidence to the carrier, fiscal intermediary, NSC or MAC that it has complied fully with the Medicare requirements, the carrier, fiscal intermediary or MAC may reinstate the supplier's billing privileges. In § 405.874(f) we adopted the provision changing the effective date for DMEPOS supplier's billing privileges. If the NSC, NSC hearing officer, or ALJ determines that a DMEPOS supplier's denied enrollment application meets the standards in § 424.57 of this chapter and any other requirements that may apply (for example, reinstatement after an OIG exclusion), the determination establishes the effective date of the billing privileges as not earlier than the date the carrier made the determination to deny the supplier's enrollment application. Claims are rejected for services furnished before that effective date. In § 405.874(g), we adopted the provision that a provider or supplier succeeding in having its enrollment application denial or billing privileges revocation reversed, or in having its billing privileges reinstated, may submit claims to the CMS contractor for services furnished during periods of Medicare qualification, subject to the limitations in § 424.44 of this chapter, regarding the timely filing of claims. In § 424.510(d)(2)(iv), we adopted the provision that at the time of enrollment, an enrollment change request or revalidation, including reenrollment of DMEPOS suppliers, providers and suppliers shall submit the CMS-588 form to receive payments via electronic funds transfer
(EFT)if they are not already receiving payments via EFT. Consistent with the authority under 31 U.S.C. 3332(f)(1), all Federal payments, including Medicare payments to providers and suppliers, shall be made by electronic funds transfer (EFT). Further, under 31 U.S.C. 3332(g), each recipient of Federal payments required to be made by electronic funds transfer shall designate 1 or more financial institutions or other authorized agents to which the payments shall be made and provide the information to CMS. While the statutory provisions at 31 CFR part 208 govern the Department of Treasury, they apply to all Federal government agencies. Consequently, we want to clarify that the EFT requirement applies to providers and suppliers enrolling in the Medicare program or making changes to enrollment. We are requiring EFT payments for the following:
(1)Providers and suppliers initially enrolling in the Medicare program;
(2)providers and suppliers submitting a CMS-855 change request who are not currently receiving payments via EFT;
(3)provider and suppliers responding to a revalidation or DMEPOS re-enrollment request; and
(4)when CMS changes a Medicare contractor for a State or contracting jurisdiction and the provider or supplier was already receiving payments via EFT. We believe that providers and suppliers already receiving payments via EFT should continue to receive payments via EFT when CMS changes a Medicare contractor for a State or contracting jurisdiction. We believe that requiring providers and suppliers who were already receiving Medicare payments via EFT prior to a change in Medicare contractors is consistent with the provisions of the proposed rule and does not impose a consequential burden on these providers and suppliers. In addition, we believe an enrolled provider or supplier who is already receiving Medicare payments electronically is not required to submit the CMS-588 with a change in enrollment unless the provider or supplier is seeking to change its depository information. Finally, we will continue to encourage all providers and suppliers to switch to EFT payments voluntarily. In § 424.545(a), we adopted the following provisions: • Redesignated the first sentence of current paragraph
(a)as the introductory text and revised that text to remove the reference to part 405 subpart H. • Redesignated the second sentence of current paragraph
(a)as paragraph (a)(1)(i). • Added paragraph (a)(1)(ii) to clarify that if a provider or supplier appeals both of these sanctions, then both matters will be resolved using a single appeals process. • Redesignated the last sentence of current paragraph
(a)as paragraph (a)(2). In § 405.874(h), we adopted the provision that established deadlines for the processing of provider enrollment actions. We adopted the provision that contractors will process initial determinations and revalidations within 180 days of receipt and that carriers, fiscal intermediaries or MACs process change-of-information and reassignment of payment requests within 90 days of receipt. In § 424.525(a)(1) and (a)(2), we adopted the provisions that state the reasons for rejecting enrollment applications by reducing the amount of time that a provider or supplier must furnish complete information requested by a contractor from 60 to 30 days. Additionally, we adopted the provision for a reduction from 60 to 30 days for the period allowed to furnish all supporting documentation for submitting their enrollment application. In this final rule, we are also making conforming changes in paragraph
(b)of this section (that is, changing 60 days to 30 days). In § 424.535(a)(8), we adopted the provision that allows Medicare FFS contractors to revoke Medicare billing privileges when instructed to do so by CMS when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. We have found numerous examples of situations where a physician or other practitioner has billed for services furnished to beneficiaries that are undeliverable, including but not limited to situations where the beneficiary was deceased, the directing physician or beneficiary was not in the State or country when services were furnished, or when the beneficiary was in another setting where these services could not be administered, or the equipment necessary for testing was not present where the testing is said to have occurred. We believe that this new revocation authority is consistent with the other types of revocations already used by CMS and its contractors under § 424.535. Further, providers and suppliers may appeal a contractor revocation using the process outlined in part 498. This basis for revocation is essential to the efficient operation of the Medicare program, because it will enable us to take an important step in protecting the expenditure of public monies for service providers whose motive and billing practices are questionable, at best, and at worst, of a sort that might prompt an aggressive response from the law enforcement community. We also want to alert providers and suppliers that we may be proposing other provisions related to revocation of providers and suppliers in the calendar year 2009 physician fee schedule proposed rule. In § 424.535(b)(2), we adopted the provision to establish a re-enrollment bar of not less than 1 year and not greater than 3 years when a provider or supplier's Medicare billing privileges are revoked. Specifically, we adopted the provision that when a provider or supplier, including all authorized officials, delegated officials and practitioners, is revoked for any of the reasons listed at § 424.535, that the provider, supplier, delegated official or authorizing official be prohibited from enrolling in the Medicare program for a period of not less than 1 year but not greater than 3 years. While we have adopted a provision to establish a re-enrollment bar for 1 year but not greater than 3 years, this enrollment bar does not preclude CMS or its contractor from denying re-enrollment if a provider or supplier was convicted of felony within the preceding 10-year period as described in § 424.530(a)(3) or is not in compliance with any other enrollment criteria. In § 498.1(g), we adopted the provision for an ALJ hearing, and judicial review for any provider or supplier whose application for enrollment or reenrollment in Medicare has been denied or whose billing privileges have been revoked. In § 498.2— • Finalizing our definition of a “supplier” to include the following:
(1)A supplier of DMEPOS; ambulance service provider; independent diagnostic testing facility; physician; and other practitioner such as physician assistant; and
(2)remove the reference to “prospective supplier.” To further clarify the provisions applicable to providers and suppliers, we have added the definition of provider and prospective provider to § 405.802. We also note that we made technical edits to the definitions of supplier in § 405.802 and § 498.2. • Revised the definition of provider to
(1)remove the reference to prospective provider; and
(2)make technical changes. These technical changes include correcting the term “hospital transplant center” to read “hospital, transplant center” and removing the phrase “that has in effect an agreement to participate in Medicare”. • Added new definitions for “prospective supplier,” “prospective provider,” largely based upon comments received. Since applicants (prospective provider and suppliers) who are not enrolled in the Medicare program, still are afforded appeal rights based on an enrollment denial, we maintain that it is important to clarify that any prospective applicant (provider or supplier) is afforded appeal rights through this process. We also adopted the provision to remove the definition of the “Office of Hearings and Appeals (OHA)” because the function of this office has been moved from the Social Security Administration to the DHHS. Additionally, we adopted the provision that revised the definition of “affected party” to specify that it includes CMS or a CMS contractor. In § 498.5, we adopted the provision that revised this section by adding a new paragraph
(l)to clarify the administrative process that would be used by a prospective provider, existing provider, prospective supplier or existing supplier dissatisfied with an initial determination or revised initial determination related to the denial or revocation of Medicare billing privileges. In § 498.5(f)(2), we adopted the provision to be consistent with the change in § 498.1(g). This implements the mandate of section 936(a)(2) of the MMA regarding judicial review. We have adopted these standards because the FFS contractors need sufficient time to adjudicate the facts and make a reasoned Medicare enrollment decision. Moreover, while we established an outside limit for processing these applications, the vast majority of these decisions are made within 120 days. In § 498.22(a), we adopted the provision to add that we have delegated authority to our contractors to reconsider an initial determination. We also are adopting the provision to revise § 498.22(b)(1) to state that a reconsideration request is to be filed with CMS or with the State survey agency, or, in the case of prospective suppliers, the entity specified in the notice of initial determination. Additionally, we adopted the provision at § 498.44 to remove the term “Associate Commissioner for Hearings and Appeals,” and we have replaced it with the term “Secretary,” because this function is no longer under the Social Security Administration; it is now under the DHHS. In § 405.874(c)(2), we adopted the provision which clarifies that a provider or supplier is required to prove that it is in compliance with all Medicare requirements for billing privileges, and that the Medicare FFS contractor incorrectly denied or revoked the supplier's billing privileges. At § 498.56, we added a new paragraph
(e)that specifies the “good cause” exception to the admission of new evidence at the ALJ level of appeal. In § 498.78(a), we adopted the proposal to delete the provision that an affected party concur in writing or on the record with a CMS or OIG request for remand. We contend that the appeals process is enhanced by allowing an ALJ to remand a provider enrollment case to the Medicare FFS contractor when CMS requests a remand. Further, we believe that a remand request could result in either a favorable decision to the appellant or in the administrative record being complete. In § 498.79, we adopted the provision that when a request for an ALJ hearing is filed after CMS or a FFS contractor has denied an enrollment application, that an ALJ must issue a decision, dismissal order or remand to CMS, as appropriate, no later than 180 days after the initial request for a hearing. We revised § 498.86 to prohibit providers and suppliers from submitting new provider enrollment issues or evidence at the DAB level of review. Finally, in § 498.88(g), we adopted the provision that when a request for a Board review is filed after an ALJ has issued a decision or dismissal order, that the Board must issue a decision, dismissal order or remand to the ALJ, as appropriate, no later than 180 days after the appeal was received by the Board. V. Collection of Information Requirements Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 30-day notice in the **Federal Register** and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget
(OMB)for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comments on the following issues: • Whether the information collection is necessary and useful to carry out the proper functions of the agency; • The accuracy of the agency's estimate of the information collection burden; • The quality, utility, and clarity of the information to be collected; and • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. However, we believe the information collection activities referenced in § 405.874 are exempt under the terms of the PRA for the following reasons: • As defined in 5 CFR 1320.4(a)(2), information collections conducted or sponsored during the conduct of criminal or civil action, or during the conduct of an administrative action, investigation, or audit involving an agency against specific individuals or entities are exempt from the PRA. • As described in 5 CFR 1320.3(h)(9), facts or opinions obtained or solicited through nonstandardized follow-up questions designed to clarify responses to approved collections, are exempt from the PRA; and • Nonstandardized information collections directed to less than 10 persons do not constitute information collections as outlined in 5 CFR 1320.3(c)(4). We believe that the collection requirements are part of the administrative process, and collected in a nonstandardized manner. Since each case will be different, based on the reasons for denial or revocation, and evidence presented, they fall under these exceptions. If you comment on any of these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group, Attn.: William Parham, CMS-6003-F, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503. Attn.: Carolyn Lovett, CMS Desk Officer, CMS-6003-F, *carolyn_lovett@omb.eop.gov* . Fax
(202)395-6974. VI. Regulatory Impact Statement We have examined the impact of this 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 on Federalism, and the Congressional Review Act (U.S.C. 804(s)). 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 rule does not reach the economic threshold and thus is not considered a major rule. The RFA requires agencies to analyze options for regulatory relief for 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 $6.5 to $31.5 million in any one year. Individuals and States are not included in the definition of a small entity. 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. We maintain that this final rule would not have an adverse impact on small entities; in fact, it would afford small suppliers a measure of protection against adverse actions by us, and extend protection to a larger group of suppliers beyond the DMEPOS suppliers currently covered under § 405.874. Because this final rule would merely clarify, expand, and update our current policy and administrative appeal rights, we anticipate slight, if any, economic impact on small entities. According to data submitted to us by carriers in calendar year 2003, approximately 166,500 enrollment applications were submitted to the Medicare carriers by suppliers seeking to receive billing privileges. We believe that a vast majority of these applicants were small businesses. Of those applications, approximately 2,000 were denied, and approximately 200 applicants requested a reconsideration. Because we have already granted appeal rights to the affected suppliers via instructions to carriers, we estimate that this regulation would have minimal impact on carrier workloads. 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 of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined that this final rule will not have a significant impact on the operations of a substantial number of small rural hospitals. There is no negative impact on the program or on small businesses. 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 expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $120 million. This rule does not mandate expenditures by either the governments mentioned or the private sector, therefore no analysis is required. 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. Since this regulation does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. Lists of Subjects 42 CFR Part 405 Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. 42 CFR Part 424 Emergency medical services, Health facilities, Health professions, Medicare Reporting and recordkeeping requirements. 42 CFR Part 498 Administrative practice and procedure, Health facilities, Health professions, 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 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED 1. The authority citation for Part 405, subpart H, continues to read as follows: Authority: Sections 1102, 1842(b)(3)(C), 1869(b), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395u(b)(3)(C), 1395ff(b) and 1395hh). Subpart H—Appeals Under the Medicare Part B Program 2. Section 405.802 is amended by adding the definitions of “provider”, “prospective provider”, “prospective supplier” and “supplier” in alphabetical order to read as follows: § 405.802 Definitions. *Prospective provider* means any of the entities specified in the definition of provider under § 498.2 of this chapter that seeks to be approved for coverage of its services by Medicare. *Prospective supplier* means any of the listed entities specified in the definition of supplier specified in this section that seeks to be approved for coverage of its services under Medicare. *Provider* means either of the following:
(1)Any of the following entities that have in effect an agreement to participate in Medicare:
(i)Hospital.
(ii)Transplant center.
(iii)Critical access hospital (CAH).
(iv)Skilled nursing facility (SNF).
(v)Comprehensive outpatient rehabilitation facility (CORF).
(vi)Home health agency (HHA).
(vii)Hospice.
(viii)Religious nonmedical health care institution (RNHCI).
(2)Any of the following entities that have in effect an agreement to participate in Medicare but only to furnish outpatient physical therapy or outpatient speech pathology services.
(i)Clinic.
(ii)Rehabilitation agency.
(iii)Public health agency. *Supplier* means any of the following entities:
(1)An independent laboratory.
(2)Supplier of durable medical equipment Prosthetics, orthotics, or supplies (DMEPOS).
(3)Ambulance service provider.
(4)Independent diagnostic testing facility.
(5)Physician or other practitioner such as physician assistant.
(6)Physical therapist in independent practice.
(7)Clinical laboratories.
(8)Supplier of portable X-ray services.
(9)Rural health clinic (RHC).
(10)Federally qualified health center (FQHC).
(11)Ambulatory surgical center (ASC).
(12)An entity approved by CMS to furnish outpatient diabetes self-management training.
(13)End-stage renal disease
(ESRD)treatment facility that is approved by CMS as meeting the conditions for coverage of its services. 3. Section 405.874 is revised to read as follows: § 405.874 Appeals of CMS or a CMS contractor. A CMS contractor's (that is, a carrier, Fiscal Intermediary or Medicare Administrative Contractor (MAC)) determination that a provider or supplier fails to meet the requirements for Medicare billing privileges.
(a)*Denial of a provider or supplier enrollment application.* If CMS or a CMS contractor denies a provider's or supplier's enrollment application, CMS or the CMS contractor must notify the provider or supplier by certified mail. The notice must include the following:
(1)The reason for the denial in sufficient detail to allow the provider or supplier to understand the nature of its deficiencies.
(2)The right to appeal in accordance with part 498 of this chapter.
(3)The address to which the written appeal must be mailed.
(b)*Revocation of Medicare billing privileges* —
(1)*Notice of revocation.* If CMS or a CMS contractor revokes a provider's or supplier's Medicare billing privileges, CMS or a CMS contractor must notify the supplier by certified mail. The notice must include the following:
(i)The reason for the revocation in sufficient detail for the provider or supplier to understand the nature of its deficiencies.
(ii)The right to appeal in accordance with part 498 of this chapter.
(iii)The address to which the written appeal must be mailed.
(2)*Effective date of revocation.* The revocation of a provider's or supplier's billing privileges is effective 30 days after CMS or the CMS contractor mails the notice of its determination to the provider or supplier. A revocation based on a Federal exclusion or debarment is effective with the date of the exclusion or debarment.
(3)*Payment after revocation.* Medicare does not pay and the CMS contractor rejects claims for services submitted with a service date on or after the effective date of a provider's or supplier's revocation.
(c)*Appeal rights.*
(1)A provider or supplier may appeal the initial determination to deny a provider or supplier's enrollment application, or if applicable, to revoke current billing privileges by following the procedures specified in part 498 of this chapter.
(2)The reconsideration of a determination to deny or revoke a provider or supplier's Medicare billing privileges will be handled by a CMS Regional Office or a contractor hearing officer not involved in the initial determination.
(3)Providers and suppliers have the opportunity to submit evidence related to the enrollment action. Providers and suppliers must, at the time of their request, submit all evidence that they want to be considered.
(4)If supporting evidence is not submitted with the appeal request, the contractor contacts the provider or supplier to try to obtain the evidence.
(5)If the provider or supplier fails to submit this evidence before the contractor issues its decision, the provider or supplier is precluded from introducing new evidence at higher levels of the appeals process.
(d)*Impact of reversal of contractor determinations on claims processing.*
(1)Claims for services furnished to Medicare beneficiaries during a period in which the supplier billing privileges were not effective are rejected.
(2)If a supplier is determined not to have qualified for billing privileges in one period but qualified in another, Medicare contractors process claims for services furnished to beneficiaries during the period for which the supplier was Medicare-qualified. Subpart C of this part sets forth the requirements for the recovery of overpayments.
(3)If a revocation of a supplier's billing privilege is reversed upon appeal, the supplier's billing privileges are reinstated back to the date that the revocation became effective.
(4)If the denial of a supplier's billing privileges is reversed upon appeal and becomes binding, then the appeal decision establishes the date that the supplier's billing privileges become effective.
(e)*Reinstatement of provider or supplier billing privileges following corrective action.* If a provider or supplier completes a corrective action plan and provides sufficient evidence to the CMS contractor that it has complied fully with the Medicare requirements, the CMS contractor may reinstate the provider's or supplier's billing privileges. The CMS contractor may pay for services furnished on or after the effective date of the reinstatement. The effective date is based on the date the provider or supplier is in compliance with all Medicare requirements. A CMS contractor's refusal to reinstate a supplier's billing privileges based on a corrective action plan is not an initial determination under part 498 of this chapter.
(f)*Effective date for DMEPOS supplier's billing privileges.* If a CMS contractor, contractor hearing officer, or ALJ determines that a DMEPOS supplier's denied enrollment application meets the standards in § 424.57 of this chapter and any other requirements that may apply, the determination establishes the effective date of the billing privileges as not earlier than the date the carrier made the determination to deny the DMEPOS supplier's enrollment application. Claims are rejected for services furnished before that effective date.
(g)*Submission of claims.* A provider or supplier succeeding in having its enrollment application denial or billing privileges revocation reversed in a binding decision, or in having its billing privileges reinstated, may submit claims to the CMS contractor for services furnished during periods of Medicare qualification, subject to the limitations in § 424.44 of this chapter, regarding the timely filing of claims. If the claims previously were filed timely but were rejected, they are considered filed timely upon resubmission. Previously denied claims for items or services rendered during a period of denial or revocation may be resubmitted to CMS within 1 year after the date of reinstatement or reversal.
(h)*Deadline for processing provider enrollment initial determinations.* Contractors approve or deny complete provider or supplier enrollment applications to approval or denial within the following timeframes:
(1)*Initial enrollments.* Contractors process new enrollment applications within 180 days of receipt.
(2)*Revalidation of existing enrollments.* Contractors process revalidations within 180 days of receipt.
(3)*Change-of-information and reassignment of payment request.* Contractors process change-of-information and reassignment of payment requests within 90 days of receipt. PART 424—CONDITIONS FOR MEDICARE PAYMENT 4. The authority citation for part 424 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). 5. Section 424.510 is amended by adding new paragraphs (d)(2)(iv) and
(e)to read as follows: § 424.510 Requirements for enrolling in the Medicare program.
(d)* * *
(2)* * *
(iv)At the time of enrollment, an enrollment change request, revalidation or change of Medicare contractors where the provider or supplier was already receiving payments via EFT, providers and suppliers must agree to receive Medicare payments via EFT, if not already receiving payment through EFT. In order to receive Medicare payments via EFT, providers and suppliers must submit the CMS-588 form.
(e)Providers and suppliers must—
(1)Agree to receive Medicare payment via electronic funds transfer
(EFT)at the time of enrollment, revalidation, change of Medicare contractors where the provider or supplier was already receiving payments via EFT or submission of an enrollment change request; and
(2)Submit the CMS-588 form to receive Medicare payment via electronic funds transfer. 6. Section 424.525 is amended by— A. Republishing paragraph
(a)introductory text. B. Revising paragraphs (a)(1), (a)(2) and (b). The revisions read as follows: § 424.525 Rejection of a provider or supplier's enrollment application for Medicare enrollment.
(a)*Reasons for rejection.* CMS contractors may reject a prospective provider's or supplier's enrollment application for the following reasons:
(1)The prospective provider or supplier fails to furnish complete information on the provider/supplier enrollment application within 30 calendar days from the date of the contractor request for the missing information.
(2)The prospective provider or supplier fails to furnish all required supporting documentation within 30 calendar days of submitting the enrollment application.
(b)*Extension of 30-day period.* CMS, at its discretion, may choose to extend the 30 day period if CMS determines that the prospective provider or supplier is actively working with CMS to resolve any outstanding issues. 7. Section 424.535 is amended by— A. Adding a new paragraph (a)(8). B. Redesignating paragraphs
(c)through
(f)as
(d)through (g). C. Adding a new paragraph (c). The addition and revision read as follows: § 424.535 Revocation of enrollment and billing privileges from the Medicare program.
(a)* * *.
(8)*Abuse of billing privileges.* The provider or supplier submits a claim or claims for services that could not have been furnished to a specific individual on the date of service. These instances include but are not limited to situations where the beneficiary is deceased, the directing physician or beneficiary is not in the State or country when services were furnished, or when the equipment necessary for testing is not present where the testing is said to have occurred.
(b)* * *
(c)*Reapplying after revocation.* After a provider, supplier, delegated official, or authorizing official has had their billing privileges revoked, they are barred from participating in the Medicare program from the effective date of the revocation until the end of the re-enrollment bar. The re-enrollment bar is a minimum of 1 year, but not greater than 3 years depending on the severity of the basis for revocation. 8. Section 424.545 is amended by revising paragraph
(a)to read as follows: § 424.545 Provider and supplier appeal rights.
(a)*General.* A prospective provider or supplier that is denied enrollment in the Medicare program, or a provider or supplier whose Medicare enrollment has been revoked may appeal CMS' decision in accordance with part 498, subpart A of this chapter.
(1)*Appeals resulting in the termination of a provider agreement.*
(i)When revocation of billing privileges also results in the termination of a corresponding provider agreement, the provider may appeal CMS' decision in accordance with part 498 of this chapter with the final decision of the appeal applying to both the billing privileges and the provider agreement.
(ii)When a provider appeals the revocation of billing privileges and the termination of its provider agreement, there will be one appeals process which will address both matters. The appeal procedures for revocation of Medicare billing privileges will apply.
(2)*Payment of unpaid claims.* Payment is not made during the appeals process. If the provider or supplier is successful in overturning a denial or revocation, unpaid claims for services furnished during the overturned period may be resubmitted. PART 498—APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT AFFECT THE PARTICIPATION OF ICFs/MR AND CERTAIN NFs IN THE MEDICAID PROGRAM 9. The authority citation for part 498 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 Provisions 10. Section 498.1 is amended by revising paragraph
(g)to read as follows: § 498.1 Statutory basis.
(g)Section 1866(j) of the Act provides for a hearing and judicial review for any provider or supplier whose application for enrollment or reenrollment in Medicare is denied or whose billing privileges are revoked. 11. Section 498.2 is amended by— A. Revising the definition of “affected party”. B. Removing the definition of “OHA”. C. Adding the definitions of “prospective provider” and “prospective supplier”. D. Revising the definitions of “provider” and “supplier”. The addition and revisions read as follows: § 498.2 Definitions. *Affected party* means a provider, prospective provider, supplier, prospective supplier, or practitioner that is affected by an initial determination or by any subsequent determination or decision issued under this part, and “party” means the affected party or CMS, as appropriate. For provider or supplier enrollment appeals, an affected party includes CMS or a CMS contractor. *Prospective provider* means any of the entities specified in the definition of provider under this section that seeks to be approved for coverage of its services by Medicare or to have any facility or organization determined to be a department of the provider or provider-based entity under § 413.65 of this chapter. *Prospective supplier* means any of the listed entities specified in the definition of supplier in this section that seek to be approved for coverage of its services by Medicare. *Provider* means either of the following:
(1)Any of the following entities that have in effect an agreement to participate in Medicare:
(i)Hospital.
(ii)Transplant center.
(iii)Critical access hospital (CAH).
(iv)Skilled nursing facility (SNF).
(v)Comprehensive outpatient rehabilitation facility (CORF).
(vi)Home health agency (HHA).
(vii)Hospice.
(viii)Religious nonmedical health care institution (RNHCI).
(2)Any of the following entities that have in effect an agreement to participate in Medicare but only to furnish outpatient physical therapy or outpatient speech pathology services.
(i)Clinic.
(ii)Rehabilitation agency.
(iii)Public health agency. *Supplier* means any of the following entities that have in effect an agreement to participate in Medicare:
(1)An independent laboratory.
(2)Supplier of durable medical equipment prosthetics, orthotics, or supplies (DMEPOS).
(3)Ambulance service provider.
(4)Independent diagnostic testing facility.
(5)Physician or other practitioner such as physician assistant.
(6)Physical therapist in independent practice.
(7)Supplier of portable X-ray services.
(8)Rural health clinic (RHC).
(9)Federally qualified health center (FQHC).
(10)Ambulatory surgical center (ASC).
(11)An entity approved by CMS to furnish outpatient diabetes self-management training.
(12)End-stage renal disease
(ESRD)treatment facility that is approved by CMS as meeting the conditions for coverage of its services. 12. Section 498.5 is amended by— A. Revising paragraph (f)(2). B. Adding a new paragraph (l). The revision and addition read as follows: § 498.5 Appeal rights.
(f)* * *
(2)A supplier or prospective supplier dissatisfied with an ALJ decision may request Board review, and has a right to seek judicial review of the Board's decision.
(l)*Appeal rights related to provider enrollment.*
(1)Any prospective provider, an existing provider, prospective supplier or existing supplier dissatisfied with an initial determination or revised initial determination related to the denial or revocation of Medicare billing privileges may request reconsideration in accordance with § 498.22(a).
(2)CMS, a CMS contractor, any prospective provider, an existing provider, prospective supplier, or existing supplier dissatisfied with a reconsidered determination under paragraph (l)(1) of this section, or a revised reconsidered determination under § 498.30, is entitled to a hearing before an ALJ.
(3)CMS, a CMS contractor, any prospective provider, an existing provider, prospective supplier, or existing supplier dissatisfied with a hearing decision may request Board review, and any prospective provider, an existing provider, prospective supplier, or existing supplier has a right to seek judicial review of the Board's decision. Subpart B—Initial, Reconsidered, and Revised Determinations 13. Section 498.22 is amended by revising paragraphs
(a)and (b)(1) to read as follows: § 498.22 Reconsideration.
(a)*Right to reconsideration* . CMS or one of its contractors reconsiders an initial determination that affects a prospective provider or supplier, or a hospital seeking to qualify to claim payment for all emergency hospital services furnished in a calendar year, if the affected party files a written request in accordance with paragraphs
(b)and
(c)of this section. For denial or revocation of enrollment, prospective providers and suppliers and providers and suppliers have a right to reconsideration.
(b)* * *
(1)With CMS or with the State survey agency, or in the case of prospective supplier the entity specified in the notice of initial determination; Subpart D—Hearings 14. Section 498.40 is amended by revising paragraph (a)(1) to read as follows: § 498.40 Request for hearing.
(a)* * *
(1)An affected party entitled to a hearing under § 498.5 may file a request for a hearing with the ALJ office identified in the determination letter. 15. Section 498.44 is revised to read as follows: § 498.44 Designation of hearing official.
(a)The Secretary or his or her delegate designates an ALJ or a member or members of the Board to conduct hearings.
(b)If appropriate, the Secretary or the delegate may designate another ALJ or another member or other members of the Board to conduct the hearing.
(c)As used in this part, “ALJ” includes any ALJ of the Department of Health and Human Services or members of the Board who are designated to conduct a hearing. 16. Section 498.56 is amended by— A. Revising paragraph (a)(2). B. Adding a new paragraph (e). The revision and addition read as follows: § 498.56 Hearing on new issues.
(a)* * *
(2)Except for provider or supplier enrollment appeals which are addressed in § 498.56(e), the ALJ may consider new issues even if CMS or the OIG has not made initial or reconsidered determinations on them, and even if they arose after the request for hearing was filed or after the prehearing conference.
(e)*Provider and supplier enrollment appeals: Good cause requirement* .
(1)*Examination of any new documentary evidence* . After a hearing is requested but before it is held, the ALJ will examine any new documentary evidence submitted to the ALJ by a provider or supplier to determine whether the provider or supplier has good cause for submitting the evidence for the first time at the ALJ level.
(2)*Determining if good cause exists* .
(i)*If good cause exists* . If the ALJ finds that there is good cause for submitting new documentary evidence for the first time at the ALJ level, the ALJ must include evidence and may consider it in reaching a decision.
(ii)*If good cause does not exist* . If the ALJ determines that there was not good cause for submitting the evidence for the first time at the ALJ level, the ALJ must exclude the evidence from the proceeding and may not consider it in reaching a decision.
(2)*Notification to all parties* . As soon as possible, but no later than the start of the hearing, the ALJ must notify all parties of any evidence that is excluded from the hearing. 17. Section 498.78 is amended by revising paragraph
(a)to read as follows: § 498.78 Remand by the Administrative Law Judge.
(a)If CMS requests a remand, the ALJ may remand any case properly before him or her to CMS. 18. A new § 498.79 is added to subpart D to read as follows: § 498.79 Timeframes for deciding an enrollment appeal before an ALJ. When a request for an ALJ hearing is filed after CMS or a FFS contractor has denied an enrollment application, the ALJ must issue a decision, dismissal order or remand to CMS, as appropriate, no later than the end of the 180-day period beginning from the date the appeal was filed with an ALJ. Subpart E—Departmental Appeals Board Review 19. Section 498.86 is amended by revising paragraph
(a)to read as follows: § 498.86 Evidence admissible on review.
(a)Except for provider or supplier enrollment appeals, the Board may admit evidence into the record in addition to the evidence introduced at the ALJ hearing (or the documents considered by the ALJ if the hearing was waived) if the Board considers that the additional evidence is relevant and material to an issue before it. 20. Section 498.88 is amended by adding a new paragraph
(g)to read as follows: § 498.88 Decision or remand by the Departmental Appeals Board.
(g)When a request for Board review of a denial of an enrollment application is filed after an ALJ has issued a decision or dismissal order, the Board must issue a decision, dismissal order or remand to the ALJ, as appropriate, no later than 180 days after the appeal was received by the Board. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program.) Dated: November 16, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: *March 17, 2008* . Michael O. Leavitt, Secretary. Editorial Note: This document was received in the Office of the Federal Register on June 20, 2008. [FR Doc. E8-14440 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 406, 407, and 408 [CMS-4129-F] RIN 0938-AO77 Medicare Program; Special Enrollment Period and Medicare Premium Changes AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule provides a special enrollment period
(SEP)for Medicare Part B and premium Part A for certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and who have health insurance that covers them while outside the United States. Under the SEP provision, qualifying volunteers can delay enrollment in Part B and premium Part A, or terminate such coverage, for the period of service outside of the United States and reenroll without incurring a premium surcharge for late enrollment or reenrollment. This final rule also codifies provisions that require certain beneficiaries to pay an income-related monthly adjustment amount (IRMAA) in addition to the standard Medicare Part B premium, plus any applicable increase for late enrollment or reenrollment. The income-related monthly adjustment amount is to be paid by beneficiaries who have a modified adjusted gross income that exceeds certain threshold amounts. It also represents the amount of decreases in the Medicare Part B premium subsidy, that is, the amount of the Federal government's contribution to the Federal Supplementary Medicare Insurance
(SMI)Trust Fund. DATES: *Effective Date:* These regulations are effective on August 26, 2008. FOR FURTHER INFORMATION CONTACT: Denise Cox,
(410)786-3195. SUPPLEMENTARY INFORMATION: I. Background A. General Medicare is a Federal health insurance program that helps millions of Americans pay for health care. Beneficiaries include eligible individuals age 65 or older and certain people younger than age 65 who also qualify to receive Medicare. These individuals include those who have disabilities and those who have permanent kidney failure (end-stage renal disease). Medicare Parts A and B are the subject of this final rule. Hospital insurance (Part A) helps to pay for inpatient care in hospitals, skilled nursing facilities, as well as home health care and hospice care. Part B or supplementary medical insurance
(SMI)helps to pay for physicians' services, outpatient hospital services, durable medical equipment, and a number of other medical services and supplies that are not covered under Part A. Part A is financed primarily through compulsory payroll taxes under the Federal Insurance Contributions Act (FICA). Individuals age 65 or over who are entitled to receive Social Security or railroad retirement benefits, or who are eligible for Social Security benefits and have filed an application for hospital insurance, are entitled to receive Part A benefits without paying a monthly premium. However, individuals who do not qualify for premium-free Part A, may voluntarily enroll in Part A but are required to pay a monthly premium. These individuals generally include those who have not worked 10 years in Medicare-covered employment or are not the spouse, divorced spouse or widow(er) of an individual who has worked 10 years in Medicare-covered employment. In addition, they must meet the following requirements:
(1)Be at least age 65;
(2)a resident of the United States;
(3)a United States citizen or an alien who has been lawfully admitted for permanent residence and who has resided continuously in the United States for the 5-year period immediately preceding the month of enrollment;
(4)not otherwise eligible to receive Part A benefits without having to pay a premium; and
(5)entitled to Part B or are eligible and have enrolled. Enrollment in Part B is open to all persons who are entitled to Part A benefits, as well as to persons who are not entitled to Part A benefits, provided certain requirements are satisfied. Part B is financed primarily through premiums paid by or on behalf of beneficiaries, along with transfers made from the General Fund of the Treasury. Section 1839(a) of the Social Security Act (the Act) requires the Secretary of Health and Human Services to determine the Medicare Part B standard monthly premium amount annually. Currently, the standard monthly premium represents approximately 25 percent of the estimated total Part B program cost for aged enrollees. The remaining 75 percent of the total estimated cost is subsidized by the Federal government through transfers to the Federal SMI Trust Fund from the General Fund of the Treasury. Individuals who do not enroll in Part B or premium Part A when first eligible or who enroll and later terminate their coverage may only enroll during the general enrollment period, which is January through March of each year, unless an exception applies. The coverage will be effective the following July 1. Under section 1839(b) of the Act, individuals who delay enrolling in premium Part A or Part B for 12 or more months must pay a premium surcharge. B. General Enrollment Period Exceptions 1. Special Enrollment Period
(SEP)Currently, section 1837(i) of the Act provides a special enrollment period
(SEP)for individuals age 65 or over who are working or who are the spouses of working individuals who are covered under a group health plan (GHP). For disabled individuals, who are under age 65, the SEP applies if the individual is covered by a GHP by reason of the current employment status of the individual or the individual's spouse, or if the individual is covered by a large group health plan
(LGHP)by reason of the current employment status of the individual or a member of the individual's family. In this type of situation, enrollment in Part B can take place anytime the individual is covered under the GHP or LGHP based on current employment status or during the 8-month period that begins the first full month after the GHP or LGHP coverage ends. Because section 1818(c) of the Act provides that the enrollment provisions in section 1837 (except subsection
(f)thereof) apply to persons authorized to enroll in premium Part A, we have extended this SEP to premium Part A enrollments. 2. Transfer Enrollment Period
(TEP)Another exception is the transfer enrollment period
(TEP)for enrollment in premium Part A. The TEP is for individuals age 65 or older who are otherwise eligible to enroll in premium Part A; are enrolled in a plan with an organization listed in section 1876 of the Act; and whose coverage under the plan is terminated for any reason. Here, an individual may enroll in premium Part A beginning any month that the individual is enrolled in the plan, and ending with the last day of the 8-month period following the last month in which the individual is no longer enrolled in the plan. 3. Statutory Changes Section 5115(a)(2) of the Deficit Reduction Act of 2005
(DRA)(Pub. L. 109-171) amended section 1837 of the Act to add a new subsection (k), which provides a SEP for certain international volunteers. Beginning January 1, 2007, a SEP for Part B is provided to qualifying international volunteers who are eligible to enroll in Part B because they meet the requirements in section 1836(1) or
(2)of the Act, but who do not enroll in Part B during the initial enrollment period or who terminate enrollment during a month in which they qualify as an international volunteer. Enrollment can take place during the 6-month period beginning on the first day of the month which includes the date the individual no longer qualifies under this provision. Coverage for an individual who enrolls during a SEP in accordance with this provision begins on the first day of the month following the month in which the individual enrolls. Under new section 1837(k)(3) of the Act, an individual qualifies as an international volunteer if he or she is serving in a program outside of the United States that covers at least a 12-month period, and that is sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 (the Code) and exempt from taxation under section 501(a) of the same Code. The individual must also have health insurance coverage to cover medical services while serving overseas in the program. Specifically, qualifying organizations under section 501(c)(3) of the Code that are exempt from taxation under section 501(a) of the Code are “corporations, and any community chest, fund, or foundation, organized and operated exclusively for religious, charitable, scientific, testing for public safety, literary, or educational purposes, or to foster national or international amateur sports competition (but only if no part of its activities involve the provision of athletic facilities or equipment), or for the prevention of cruelty to children or animals. * * *” Furthermore, to qualify for this exemption, no part of the net earnings of the organization can inure to the benefit of any private shareholder or individual and no substantial part of the activities can be used for propaganda, or otherwise attempt to influence legislation (except as otherwise provided in section 510(h) of the Code) or participate or intervene (including the publishing or distributing of statements) in political campaigns on behalf of (or in opposition to) any candidate for public office. C. Income-Related Monthly Adjustment Amount Under Medicare Part B Section 811 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)(Pub. L. 108-173) amends section 1839 of the Act and establishes a Medicare Part B premium subsidy reduction referred to as the “Income-Related Monthly Adjustment Amount” (IRMAA). Section 1839(i) of the Act requires that an income-related monthly adjustment amount be added to a beneficiary's Part B premium if his or her modified adjusted gross income exceeds the established threshold amounts. The IRMAA reduces the amount that the beneficiary's premium is subsidized by the Federal government. All beneficiaries will continue to receive some subsidy of their premium. Section 1839(i) of the Act establishes a sliding scale that will be used to establish four income-related monthly adjustment amounts that will increase a beneficiary's Medicare Part B premium by specific percentages. If a beneficiary's modified adjusted gross income is greater than the statutory threshold amounts, the beneficiary will pay a larger portion of the estimated total cost of Part B coverage. The 2007 income ranges, as set forth in section 1839(i)(3)(C)(i) of the Act, started at $80,000 for a beneficiary filing an individual tax return, and $160,000 for a beneficiary filing a joint income tax return, and are listed in the following table: Individual tax filers with income: Joint tax filers with income: Premium percentage Greater than $80,000 and less than or equal to $100,000 Greater than $160,000 and less than or equal to $200,000 35 Greater than $100,000 and less than or equal to $150,000 Greater than $200,000 and less than or equal to $300,000 50 Greater than $150,000 and less than or equal to $200,000 Greater than $300,000 and less than or equal to $400,000 65 Greater than $200,000 Greater than $400,000 80 In calendar year
(CY)2007, individual tax filers with income less than or equal to $80,000 and joint tax filers with income less than or equal to $160,000 will continue to pay the standard premium which represents roughly 25 percent of the estimated total Part B program costs. As specified in section 1839(i)(5) of the Act, each dollar amount in this table would be adjusted annually based on the Consumer Price Index. Section 811 of the MMA also provided for a 5-year phase-in of the Medicare Part B premium subsidy reduction. However, section 1839(i) was subsequently amended by section 5111 of the DRA to provide for a 3-year phase-in period. Therefore, the percentages presented in this table reflect the Part B premium percentages that certain beneficiaries will pay once IRMAA is fully phased-in. The “hold-harmless” provision in section 1839(f) of the Act provides for a reduction to the Part B premium for beneficiaries whose Social Security or Railroad Board
(RRB)annuity cost of living adjustments (COLAs) are not sufficient to cover the Part B premium increase. If in a given year, the increase in the Part B premium would cause an individual's Social Security or RRB check to be less than it was the year before, the premium is reduced to ensure that the amount of the individual's Social Security benefit (or RRB annuity) stays the same. To be held harmless, a beneficiary must have had the Part B premium deducted from both the December check of the prior year and the January check of the next year. Under section 1839(f) of the Act, the “hold-harmless” provision does not apply to beneficiaries who are required to pay an IRMAA based on their modified adjusted gross income. These beneficiaries must pay the full Medicare Part B standard monthly premium, plus any applicable penalty for late enrollment or reenrollment, plus the income-related monthly adjustment amount. Section 702(a)(5) of the Act allows SSA to make the rules and regulations necessary or appropriate to carry out the functions of SSA. Other provisions in section 811 of the MMA provide SSA with additional specific authorization to make rules and regulations to determine which beneficiaries are required to pay the different income-related monthly adjustment amounts. In the October 27, 2006 **Federal Register** (71 FR 62923), SSA issued a final rule establishing regulations governing the determination of income-related monthly adjustment amounts. This final rule explains:
(1)The statutory requirement to implement an income-related adjustment to the Part B premium subsidy;
(2)the information that would be used to determine whether a beneficiary must pay an income-related monthly adjusted amount and the amount of any adjustment;
(3)when SSA will consider a major life-changing event that results in a significant reduction in a beneficiary's modified adjusted gross income; and
(4)how a beneficiary can appeal SSA's determination about the beneficiary's income-related monthly adjustment amount. For a more detailed discussion see SSA's October 27, 2006 final rule (71 FR 62923). II. Provisions of the Proposed Regulation and Analysis of and Responses to Public Comments We received four timely public comments in response to the Special Enrollment Period and Medicare Premium Changes proposed rule published in the September 28, 2007 **Federal Register** . In this section of the final rule, we address all comments received regarding the provisions of our proposed rule. We proposed to add a new § 406.25, which would allow certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and have health care insurance to qualify for a SEP for premium hospital insurance (Part A). We recognize that section 5115 of the DRA, in amending section 1839(b) of the Act, explicitly provides only for a SEP for Part B, which we have provided for in new § 407.21. However, since section 1818(c) of the Act applies all of the provisions of section 1837 of the Act (except subsection
(f)thereof) to persons authorized to enroll under section 1818 of the Act, we believe that the SEP provided in section 5115 of the DRA also applies to enrollment in premium Part A. *Comment:* Three commenters expressed concern that although § 406.25 of the September 2007 proposed rule tracks the language of section 5115 of the DRA, § 407.21 is not worded exactly the same as § 406.25 and could be interpreted as imposing different standards. Specifically, they believe that the requirements of § 406.25 (“an individual [that] is serving as a volunteer outside the United States through a program that covers at least a 12-month period”) and the requirement of § 407.21 (“if while serving as a volunteer outside of the United States the individual is in a program that covers a 12-month period of service outside of the United States”) are two different standards. The commenters also note that there is a slight difference between the wordings in the preamble for these two sections. They believe that § 406.25 and § 407.21 should be substantively identical. *Response:* To ensure that the SEP standards are interpreted consistently, we are revising the regulation text of § 406.25 and § 407.21. In § 406.33(a)(3), we proposed to make a technical correction by removing an incorrect phrase “the 7-month special enrollment period under § 406.21(e)” and replacing it with the phrase “the special enrollment period under § 406.24.” We did not receive any public comment on this proposal and are adopting the provision with only a technical change, as discussed further in this section. In § 406.33(a)(5) and (6), we proposed to exclude from the calculation of the premium surcharge those months the individual qualifies for the SEP described in § 406.25(a). We did not receive any public comment on this proposal and are adopting the provision with technical changes, as discussed further in this section. We proposed to add a new § 407.21, which implements section 5115 of the DRA by allowing certain individuals who are sponsored by prescribed organizations as volunteers outside of the United States and have health care insurance that covers medical services while serving overseas to qualify for a Medicare Part B SEP. *Comment:* Two commenters noted that section 5115 of the DRA requires that volunteers serve in a program that covers at least a 12-month period, as opposed to requiring that their actual service outside the country last for at least 12 months. These commenters stated that, under rare, unforeseeable circumstances, a volunteer in a program that covers at least a 12-month period may be required to return to the United States in less than 12 months. They believe that these volunteers should qualify for the SEP provided by section 5115 of the DRA. *Response:* We agree and have revised § 407.21 to clarify that the volunteer has to serve in a program that covers at least a 12-month period. In § 408.20 (e)(3)(iii), we proposed to implement section 811(b)(1)(C) of the MMA by excluding from the “hold harmless” provision (known as the “nonstandard premium”) individuals who are required to pay the income-related monthly adjustment amount (IRMAA). Such beneficiaries must pay the full Medicare Part B standard monthly premium plus any applicable premium surcharge for late enrollment or re-enrollment, plus the income-related monthly adjustment amount. We did not receive any public comment on this proposal and are adopting the provision as proposed. In § 408.24(a)(10), we proposed to implement section 5115(a) of the DRA by excluding from the calculation of the premium surcharge those months the individual meets the requirements of proposed § 407.21. We also proposed to make a conforming change in § 408.24 (b)(2)(i) of this section by revising the cross-reference to include the new paragraph § 408.24(a)(10). We did not receive any public comment on these proposals and are adopting the provisions as proposed. Finally, we proposed to add a new § 408.28 to specify that, beginning January 1, 2007, Medicare beneficiaries will be informed that they may be required to pay an income-related monthly adjustment amount in addition to the standard Part B premium, plus any applicable increase for late enrollment or reenrollment, if their modified adjusted gross income exceeds the threshold limits specified in 20 CFR 418.1115. We did not receive any public comment on this proposal and are adopting the provision as proposed. After review and analysis of public comment, we are also making the following technical changes in this final rule: • In § 406.33(a)(3), the cross-reference “§ 406.24 of this part” is revised to read “§ 406.24 of this subpart”. • In § 406.33(a)(5), the cross-reference “§ 406.25 of this subpart” is revised to read “for a SEP under 406.25(a) of this subpart”. • In § 406.33(a)(6), the cross-reference “§ 406.25(b) of this part” is revised to read “§ 406.25(b) of this subpart”. • In § 407.21(b), the cross-reference “paragraph
(b)of this section” is revised to read “paragraph
(a)of this section”. Lastly, we are making a technical change to the section heading for § 406.24 to clarify that the special enrollment period relates to coverage under group health plans. III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the **Federal Register** and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget
(OMB)for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs). A. ICRs Related to Special Enrollment Period for Volunteers Outside the United States (§ 406.25) Section 406.25 outlines the requirements that an individual volunteer must meet to qualify for a SEP. A qualifying individual can enroll or reenroll without incurring a surcharge for a late enrollment or reenrollment. Specifically, § 406.25(a)(1) and
(2)state that an individual volunteer must demonstrate that his or her volunteer service is through a program that covers at least a 12-month period and is sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under section 501(a) of the Internal Revenue Code. The burden associated with this requirement is the time and effort associated with verifying that the volunteer was in a 12-month program and demonstrating the tax-exempt status of the organization sponsoring the individual. The estimated burden associated with this requirement is 15 minutes per individual. We estimate that 1,500 individuals will be subject to this requirement on a yearly basis for a total annual burden of 375 burden hours. In addition, § 406.25(a)(3) requires that an individual demonstrate that he or she has health insurance that covers medical services received outside of the United States during his or her period of service. The burden associated with this requirement is the time and effort associated with demonstrating possession of health insurance coverage that covers the medical services received outside of the United States. We estimate the burden for verifying coverage to be 15 minutes per individual; we also estimate that 1,500 individuals will be subject to this requirement on a yearly basis. The total estimated burden is 375 annual burden hours. B. ICRs Related to Special Enrollment Period for Volunteers Outside the United States (§ 407.21) Section 407.21 addresses the provision of a SEP for an individual who elects not to enroll or to be deemed enrolled in SMI when first eligible and an individual who terminates SMI enrollment. To be eligible for the SEP, the individual must meet the criteria outlined in the regulations text. As stated in § 407.21(a), the individual must:
(1)Serve as a volunteer in a program that covers at least a 12-month period of service;
(2)be a volunteer in a program sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under 501(a) of such Code; and
(3)be able to demonstrate that he or she had health insurance coverage that covers medical services received outside of the United States during his or her period of service. The burden associated with the requirements in § 407.21(a)(1) and
(2)is the time and effort associated with verifying that the volunteer was in a 12-month program, and demonstrating the tax-exempt status of the organization sponsoring the individual, and submitting the information to CMS. The burden associated with these requirements is discussed in detail in the explanation of the burden for § 406.25. The burden associated with the § 407.21(a)(3) is the time and effort associated with an individual demonstrating that he or she has health insurance that covers medical services received outside of the United States during his or her period of service. The burden associated with this requirement is discussed in detail in the explanation of the burden for § 406.25. Table A.—Estimated Annual Reporting and Recordkeeping Burden Regulation section(s) OMB Control No. Respondents Responses Burden per response (hours) Total annual burden (hours) § 406.25(a)(1 and 2) and § 407.21(a)(1 and 2) 0938-New 1500 1500 .25 375 § 406.25(a)(3) and § 407.21(a)(3) 0938-New 1500 1500 .25 375 Total 750 We have submitted a copy of this final rule to OMB for its review of the information collection requirements contained in this section. In addition, we are seeking OMB approval for the aforementioned information collection requirements under a separate notice and comment process. These requirements are not final until they are approved by OMB. IV. Regulatory Impact Statement We have examined the impact of this 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). We do not anticipate that there will be more than 1,500 beneficiaries (international volunteers) at any one time who will qualify for a SEP. To qualify under this SEP, the Medicare beneficiary must have elected not to enroll in Part B or premium Part A during the initial enrollment period, or terminated enrollment, because the individual was serving as a volunteer outside the United States. In addition, the individual must have served as a volunteer outside of the United States in a program that covers at least a 12-month period, and that is sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under section 501(a) of that Code, and must have health care insurance coverage that covers medical services while serving overseas in the program. It is for this reason that we anticipate that the overall expenditure for this provision of the Medicare program projected over a 5-year period would be negligible. In addition, this rule only codifies the income-related monthly adjustment amount provision of MMA. It is for these reasons that this rule does not reach the economic threshold and thus is not considered a major rule. 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 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. 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. 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 of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act, because we have determined that this final 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 mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $120 million. This rule will have no consequential effect on State, local, or tribal governments or on the private sector. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed (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 determined that this final rule does not impose any costs on State or local governments, therefore the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects 42 CFR Part 406 Health facilities, Kidney diseases, Medicare. 42 CFR Part 407 Medicare. 42 CFR Part 408 Medicare. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV as follows: PART 406—HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT 1. The authority citation for part 406 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart C—Premium Hospital Insurance 2. Section 406.24 is amended by revising the section heading to read as follows: § 406.24 Special enrollment period related to coverage under group health plans. 3. Section 406.25 is added to read as follows: § 406.25 Special enrollment period for volunteers outside the United States.
(a)*General rule* . A SEP, as defined in § 406.24(a)(4) of this subchapter, is provided for an individual that meets the following requirements:
(1)The individual is serving as a volunteer outside of the United States in a program that covers at least a 12-month period.
(2)The individual is in a program that is sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of Internal Revenue Code of 1986.
(3)The individual can demonstrate that he or she has health insurance that covers medical services that the individual receives outside the United States while serving in the program.
(4)The individual—
(i)At the time he or she first met the requirements of § 406.10 through 406.15 or § 406.20(b), elected not to enroll in premium hospital insurance during the individual's initial enrollment period; or
(ii)Terminated enrollment in premium hospital insurance during a month in which the individual met the requirements of this section for a SEP.
(b)*Duration of SEP* . The SEP is the 6-month period beginning on the first day of the month that includes the date that the individual no longer meets the requirements of paragraph
(a)of this section.
(c)*Effective date of coverage* . Coverage under a SEP authorized by this section begins on the first day of the month following the month in which the individual enrolls. 4. Section 406.33 is amended by— A. Revising paragraph (a)(3). B. Adding paragraphs (a)(5) and (a)(6). The revision and additions read as follows: § 406.33 Determination of months to be counted for premium increase: Enrollment.
(a)* * *
(3)Any months during the SEP under § 406.24 of this subpart, during which premium hospital insurance coverage is in effect.
(5)For premiums due for months after December 2006, any months during which the individual met the requirements for a SEP under § 406.25(a) of this subpart.
(6)Any months during the 6-month SEP described in § 406.25(b) of this subpart during which premium hospital insurance coverage is in effect. PART 407—SUPPLEMENTARY MEDICAL INSURANCE
(SMI)ENROLLMENT AND ENTITLEMENT 5. The authority citation for part 407 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart B—Individual Enrollment and Entitlement for SMI 6. Section 407.21 is added to read as follows: § 407.21 Special enrollment period for volunteers outside the United States.
(a)*General rule* . A SEP, as defined in § 406.24(a)(4) of this subchapter, is provided for an individual who does not elect to enroll or to be deemed enrolled in SMI when first eligible, or who terminates SMI enrollment, if the individual meets the following requirements:
(1)The individual is serving as a volunteer outside of the United States in a program that covers at least a 12-month period.
(2)The individual is in a program that is sponsored by an organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and is exempt from taxation under section 501(a) of the Internal Revenue Code of 1986.
(3)The individual demonstrates that he or she has health insurance that covers medical services that the individual receives outside of the United States while serving in the program.
(b)*Duration of SEP* . The SEP is the 6-month period beginning on the first day of the month that includes the date that the individual no longer satisfies the provisions of paragraph
(a)of this section.
(c)*Effective date of coverage* . Coverage under a SEP authorized by this section, begins on the first day of the month following the month in which the individual enrolls. PART 408—PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE 7. The authority citation for part 408 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart B—Amount of Monthly Premiums 8. Section 408.20 is amended by adding paragraph (e)(3)(iii) to read as follows: § 408.20 Monthly premiums.
(e)* * *
(3)* * *
(iii)Beginning with CY 2007, a nonstandard premium may not be applied to individuals who are required to pay an income-related monthly adjustment amount described in § 408.28 of this part. 9. Section 408.24 is amended by— A. Adding paragraph (a)(10). B. Revising paragraph (b)(2)(i). The addition and revision read as follows: § 408.24 Individuals who enrolled or reenrolled before April 1, 1981 or after September 30, 1981.
(a)* * *
(10)For premiums due for months beginning with January 1, 2007, the following:
(i)Any months after December 2006 during which the individual met the conditions under § 407.21(a) of this chapter.
(ii)Any months of Part B
(SMI)coverage for which the individual enrolled during a special enrollment period as provided in § 407.21(b) of this chapter.
(b)* * *
(2)* * *
(i)Any of the periods specified in paragraph
(a)of this section; and 10. Section 408.28 is added to read as follows: § 408.28 Increased premiums due to the income-related monthly adjustment amount (IRMAA). Beginning January 1, 2007, Medicare beneficiaries must pay an income-related monthly adjustment amount in addition to the Part B
(SMI)standard monthly premium, plus any applicable increase for late enrollment or reenrollment, if the beneficiary's modified adjusted gross income exceeds the threshold amounts specified in 20 CFR 418.1115. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: January 31, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: April 7, 2008. Michael O. Leavitt, Secretary. [FR Doc. E8-14040 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 482 [CMS-3014-F] RIN 0938-AJ29 Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor. DATES: *Effective Date:* The interim final rule amending 42 CFR part 482 published August 24, 2007 at 72 FR 48562 and effective on February 20, 2008, is adopted as final June 27, 2008. FOR FURTHER INFORMATION CONTACT: Mary Collins,
(410)786-3189. Marcia Newton,
(410)786-5265. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 1861(e) of the Social Security Act (the Act), hospitals must meet certain conditions in order to participate in the Medicare program. These conditions are intended to protect patient health and safety and ensure that high-quality care is provided. Hospitals receiving payment under Medicaid must meet the Medicare conditions of participation (CoPs). The CoPs for hospital laboratory services currently specifies the steps hospitals must take when they become aware they have administered potentially human immunodeficiency virus infectious blood or blood components to a patient. All laboratories must be CLIA-certified to participate in Medicare and Medicaid. The Centers for Medicare & Medicaid Services
(CMS)and Federal agencies that comprise the Public Health Services, including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), are responsible for ensuring the safety of blood and blood components. Hepatitis C virus
(HCV)was first discovered and established as a causative agent of transfusion-associated hepatitis in the late 1980s. In October 1989, FDA's Blood Products Advisory Committee
(BPAC)first discussed steps to identify and quarantine potentially HCV infectious blood and blood components remaining in storage and notify recipients that they may possibly have received infectious blood or blood products. These steps are known as a “lookback.” BPAC advised that there was insufficient information available concerning HCV infection to propose either product quarantine or notification of recipients transfused with blood and blood components prepared from prior collections from donors later determined to be at increased risk for transmitting HCV. On November 16, 2000, we published in the **Federal Register** a proposed rule (65 FR 69416). In that proposed rule, we discussed in detail the steps that had been taken since the late 1980's to avoid the transmission of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor. On August 24, 2007, we published an interim final rule with comment period in the **Federal Register** (72 FR 48562). The interim final rule with comment period incorporated the provisions of the November 16, 2000 proposed rule, responses to public comments, and changes to further conform our regulation to FDA's final rule that was also published on August 24, 2007. For a detailed discussion of this information, we refer the reader to the August 24, 2007 interim final rule (72 FR 48562 through 48565). II. Provisions of the Interim Final Rule With Comment Period In order to have consistent industry standards for potentially infectious blood and blood components, on August 24, 2007, we published in the **Federal Register** an interim final rule with comment period (72 FR 48562) entitled, “Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services”. The provisions of the interim final rule were effective on February 20, 2008. The interim final rule with comment period addressed the comments CMS received regarding the proposed rule that was published on November 16, 2000 (65 FR 69416). Since our proposed rule was published in conjunction with the FDA's rule, we coordinated our responses with the FDA's responses in its “lookback” rule (72 FR 48766) entitled, “Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection” (“lookback”). In the interim final rule with comment period, we implemented the following provisions— • Changed the reference of “blood establishments” to “blood collecting establishments” (BCE). Under this requirement, a BCE must notify a hospital if it supplies such hospital with potentially HCV infectious blood. • Amended the hospital conditions of participation to require hospitals to develop agreements with outside BCEs under which the BCE would notify the hospital if it supplied the hospital with potentially HCV infectious blood and blood components. • Required hospitals, when notified by BCEs, to quarantine prior collections from a donor who later tested repeatedly reactive for evidence of HCV infection, and to notify transfusion recipients of the prior collections, based on further testing of the donor, as appropriate. • Required blood banks to notify a hospital of potentially infected blood within 3 calendar days after testing. We also require hospitals to make at least three attempts to notify the patient, or to notify the attending physician who ordered the blood or blood components. • Required hospitals to destroy and re-label previous collection of blood or blood components held in quarantine if the results of the testing were indeterminate. • Required hospitals to maintain adequate records of the source and disposition of all units of blood and blood components for at least 10 years after the date of disposition. III. Analysis of and Responses to Public Comments and Provisions of the Final Regulation We did not receive any public comments on the August 24, 2007 interim final rule with comment period. Therefore, the provisions of this final rule are identical to the provisions of the August 24, 2007 interim final rule with comment period (72 FR 48562). IV. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the **Federal Register** and solicit public comment when a collection of information requirement is submitted to the Office of Management and Budget
(OMB)for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of our agency. • The accuracy of our estimate of the information collection burden. • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We solicited public comment on each of these issues for the following sections of this document that contain information collection requirements. Condition of Participation: Laboratory Services (§ 482.27) Section 482.27(b)(3) requires a hospital that regularly uses the services of an outside BCE to establish and maintain a written agreement with the BCE that governs the procurement, transfer, and availability of blood and blood components. This section also requires the BCE to notify the hospital within 3 calendar days after the date on which the donor tested reactive for evidence of HCV infection or after the date on which the blood establishment was made aware of other test results indicating evidence of HCV infection, as outlined in (b)(3)(i) through (iii). Section 482.27(b)(5) requires a hospital to maintain, in a manner that permits prompt retrieval, adequate records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition. In addition, this section requires a hospital to maintain a fully funded and documented plan that will allow the hospital to transfer these records to another hospital or other entity if such hospital ceases operation for any reason. Section 482.27(b)(6) requires a hospital that has administered potentially HIV or HCV infectious blood or blood components (either directly through its own BCE or under an agreement), or released the blood or blood components to another entity or individual, to make reasonable attempts to notify the patient, or to notify the attending physician or the physician who ordered the blood or blood component and ask the physician to notify the patient, that potentially HIV or HCV infectious blood or blood components were transfused to the patient. Time frame and notification requirements are outlined in § 482.27(b)(6), (b)(7), and (b)(8). Section 482.27(b)(9) requires a hospital to maintain policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for the confidentiality of medical records. Section 482.27(b)(10) requires a physician or hospital, if the patient has been adjudged incompetent by a State court, to notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient's behalf, the physician or hospital must notify the patient or his or her legal representative or relative. If the patient is deceased, the physician or hospital must continue the notification process for HIV infection and inform the deceased patient's legal representative or relative. If the patient is a minor, the legal guardian must be notified. While all of the aforementioned information collection requirements referenced are subject to the Paperwork Reduction Act, the associated burden is captured and discussed in the Food and Drug Administration's
(FDA)final regulation titled “Current Good Manufacturing Practice for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection” (72 FR 48766). The FDA's rule assigns a one-time burden of 16 hours for hospitals to develop procedures to conduct lookback activities. We also require hospitals that currently receive blood from an outside BCE to have an agreement with the BCE that governs the procurement, transfer, and availability of blood and blood components for HIV. Our rule requires hospitals to modify their current agreements to include HCV. Although the FDA does not require hospitals to have an agreement with a BCE, we believe that the time necessary to perform this task will be minimal and is already captured in the 16 hours allotted in the FDA rule. In the interim final rule with comment period, we assigned 1 token hour of burden to these requirements; however, we are no longer assessing 1 token burden hour for the information collection requirements because, as stated earlier, the burden associated with the information collection requirements contained in this final rule was addressed in the FDA's final rule (72 FR 48766). The burden associated with the FDA's final rule was approved under OMB control number 0910-0610 with an October 31, 2010, expiration date. We have submitted a copy of this final rule to OMB for its review of the information collection requirements. These requirements are not effective until they have been approved by OMB. 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 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism and the Congressional Review Act (5 U.S.C. 804(2)). In the August 24, 2007 interim final rule with comment period, we presented a full regulatory impact analysis that discussed the costs and benefits of the rule. The provisions of the interim final rule with comment period became effective on February 20, 2008. For a full description of the regulatory impact analysis, we refer the reader to the August 24, 2007 interim final rule (see 72 FR 48570 through 48574). We did not receive any comments on the August 24, 2007 interim final rule with comment period; and therefore, we have not made any changes to the regulatory impact analysis in this final rule. This rule merely finalizes, without change, the interim final rule, which is already in effect. Therefore, we have determined that this final rule has no economic impact. Executive Order 12866 (as amended) 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 must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). The August 24, 2007 interim final rule with comment period estimated a one-time cost of $41.6 million and an annual cost of $1.7 million. Because the estimated cost falls below the threshold for a major rule, we have determined that this final rule is not a major rule. 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 hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $31.5 million in any 1 year. For purposes of the RFA, a majority of hospitals are considered small entities due to their non-profit status. The agency has examined the impact on small entities and the Secretary has determined that this final rule will not have a significant economic impact on a substantial number of small entities. Individuals and States are not included in the definition of a small entity. 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 of a Metropolitan Statistical Area (superseded by “core-based statistical areas”) and has fewer than 100 beds. As stated above, the Secretary has determined that this final rule will not have a significant impact on 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 mandates impose spending costs on State, local, or tribal governments in the aggregate, or by private sector in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $130 million. We believe this final rule will not be an economically significant rule as described in the Executive Order, or a significant action as defined in the Unfunded Mandates Reform Act. Aggregate impacts and expenditures imposed by this final rule, will not reach $130 million for State, local, or tribal governments in the aggregate, or by the private sector. We did not receive any comments on the August 24, 2007 interim final rule with comment period, and as previously stated above, we have not made any changes to the impact analysis in this final rule. As summarized, the impacts in the interim rule with comment period presented an overall one-time cost of $41.6 million and an annual cost of $1.7 million. The one-time cost of $41.6 million consists of $2.7 million for the development of HCV lookback procedures and $38.9 million for the historical record review (retrospective lookback effort). The annual cost of $1.7 million consists of $1.4 million for record retention (retain records for 10 years) and $0.3 million for prospective reviews. 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 determined that the rule does not contain policies that 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. Accordingly, we have concluded that the rule does not contain policies that have Federalism implications as defined in the Executive Order 13132 and, consequently, a Federalism summary impact statement is not required. B. Conclusion In addition to the prospective HIV lookback that hospitals are currently required to perform, hospitals are also required to conduct a lookback of transfusion recipients of potentially HCV-infected blood. This final rule also requires hospitals to have in their agreements with BCEs, that BCEs notify hospitals after performing their own FDA-mandated lookback. In accordance with the provisions of Executive Order 12866, this final rule was not reviewed by the Office of Management and Budget. List of Subjects in 42 CFR Part 482 Grant programs-health, Hospitals, Medicaid, Medicare, Reporting and recordkeeping requirements. The interim final rule with comment period amending 42 CFR Part 482, which was published on August 24, 2007, in the **Federal Register** at 72 FR 48562 through 48574, is adopted as a final rule. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: April 25, 2008. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: May 22, 2008. Michael O. Leavitt, Secretary. [FR Doc. E8-13279 Filed 6-26-08; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 67 [Docket No. FEMA-B-7791] Withdrawal of Final Flood Elevation Determination for the District of Columbia, Washington, DC AGENCY: Federal Emergency Management Agency (FEMA), DHS. ACTION: Final rule; withdrawal. SUMMARY: The Federal Emergency Management Agency
(FEMA)withdraws the final flood elevation determinations for the District of Columbia, published in the **Federal Register** on April 17, 2008, at 73 FR 20810, 20814-20815. Final flood elevation determinations will be made at a later date. DATES: *Effective Date:* This rule is effective June 27, 2008. FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Engineering Management Section, Mitigation Division, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-3151. SUPPLEMENTARY INFORMATION: On March 26, 2008, FEMA issued a letter to the District of Columbia (“the District”) finalizing that community's flood elevation determinations. The final flood elevation information was published in the **Federal Register** on April 17, 2008, at 73 FR 20810, 20814-20815. The March 26, 2008 letter also established September 26, 2008 as the anticipated effective date for the Flood Insurance Study
(FIS)and Flood Insurance Rate Map
(FIRM)for the District. Pending further consideration, the finalization of the above FIS and FIRM has been postponed. It is therefore necessary at this time to rescind the final flood elevation determinations issued to the District on March 26, 2008. Until FEMA determines that the District's FIRM can be processed, the community's final flood elevation determinations are hereby withdrawn in accordance with section 110 of the Flood Disaster Protection Act of 1973, codified at 42 U.S.C. 4104. *National Environmental Policy Act* . This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared. *Regulatory Flexibility Act* . As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required. *Regulatory Classification* . This final rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. *Executive Order 13132, Federalism* . This rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform* . This rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 67 Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements. Accordingly, 44 CFR part 67 is amended as follows: PART 67—[AMENDED] 1. The authority citation for part 67 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 67.11 [Amended] 2. The tables published under the authority of § 67.11 are amended to withdraw the following: The final flood elevation determination published at 73 FR 20810, 20814-20815, April 17, 2008 for the District of Columbia. Dated: June 19, 2008. Michael K. Buckley, Deputy Assistant Administrator for Mitigation, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E8-14328 Filed 6-26-08; 8:45 am] BILLING CODE 9110-12-P 73 125 Friday, June 27, 2008 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2008-0674; Directorate Identifier 2008-NM-086-AD] RIN 2120-AA64 Airworthiness Directives; Avions Marcel Dassault-Breguet Model Falcon 10 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to supersede an existing airworthiness directive
(AD)that applies to all Avions Marcel Dassault-Breguet Model Falcon 10 airplanes. The existing AD currently requires either revising the airplane flight manual
(AFM)and installing a placard in the flight deck to prohibit flight into known or forecasted icing conditions, or repetitively inspecting for delamination of the flexible hoses in the wing
(slat)anti-icing system and performing corrective actions if necessary. The existing AD also requires replacement of the flexible hoses installed in the slat anti-icing systems, which ends the repetitive inspections. This proposed AD would continue to require replacement of the flexible hoses installed in the slat anti-icing systems with new hoses, but at intervals defined in flight hours instead of flight cycles. This proposed AD results from information we received from operators and the airplane manufacturer indicating that the repetitive interval for the required replacement deviated from the referenced service information. We are proposing this AD to prevent collapse of the flexible hoses in the slat anti-icing system, which could lead to insufficient anti-icing capability and, if icing is encountered in this situation, could result in reduced controllability of the airplane. DATES: We must receive comments on this proposed AD by July 28, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this AD, contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, New Jersey 07606. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.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 this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2008-0674; Directorate Identifier 2008-NM-086-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion On August 17, 2007, we issued AD 2007-18-08, amendment 39-15188 (72 FR 51161, September 6, 2007), for all Avions Marcel Dassault-Breguet Model Falcon 10 airplanes. That AD requires either revising the airplane flight manual
(AFM)and installing a placard in the flight deck to prohibit flight into known or forecasted icing conditions, or repetitively inspecting for delamination of the flexible hoses in the wing
(slat)anti-icing system and performing corrective actions if necessary. That AD also requires replacement of the flexible hoses installed in the slat anti-icing systems with new hoses, which ends the repetitive inspections. That AD resulted from a report of in-service delamination of a flexible hose in the slat anti-icing system at a time earlier than previously reported. We issued that AD to prevent collapse of the flexible hoses in the slat anti-icing system, which could lead to insufficient anti-icing capability and, if icing is encountered in this situation, could result in reduced controllability of the airplane. Actions Since Existing AD Was Issued Since issuance of AD 2007-18-08, we have received information from operators and the airplane manufacturer indicating that the repetitive interval for accomplishing the replacement of the flexible hoses required by paragraph
(k)of that AD deviated from the referenced service information ( *i.e.* , Dassault Service Bulletin F10-313, Revision 1, dated May 10, 2006). As published, paragraph
(k)of AD 2007-11-07 reads “* * * Repeat the hose replacement at intervals not to exceed 700 flight cycles.” The term “flight cycles” is incorrect. We inadvertently used the term “flight cycles” instead of “flight hours” in this sentence. Therefore, we have determined that additional rulemaking is necessary to revise the repetitive interval for replacing the flexible hoses from 700 flight cycles to 700 flight hours. Existing Relevant Service Information Dassault has previously issued Service Bulletin F10-313, Revision 1, dated May 10, 2006. The service bulletin describes procedures for replacing the flexible hoses installed in the slat anti-icing system with new hoses. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The EASA mandated the service information and issued EASA airworthiness directive 2006-0114, dated May 10, 2006, to ensure the continued airworthiness of these airplanes in the European Union. FAA's Determination and Requirements of the Proposed AD These airplanes are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. As described in FAA Order 8100.14A, “Interim Procedures for Working with the European Community on Airworthiness Certification and Continued Airworthiness,” dated August 12, 2005, the EASA has kept the FAA informed of the situation described above. We have examined the EASA's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States. This proposed AD would supersede AD 2007-18-08 and would continue to require replacement of the flexible hoses installed in the slat anti-icing systems with new hoses, but at new repetitive intervals. This proposed AD would require accomplishing the actions specified in service bulletin described previously. Change to Existing AD This proposed AD would retain certain requirements of AD 2007-18-08. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table: Revised Paragraph Identifiers Requirement in AD 2007-18-08 Corresponding requirement in this proposed AD paragraph
(k)paragraph (f). paragraph
(l)paragraph (g). Costs of Compliance The following table provides the estimated costs for U.S. operators to comply with this proposed AD. Estimated Costs Action Work hours Parts Cost per airplane Number of U.S.-registered airplanes Fleet cost Hose replacement 8 $880 $1,520 per replacement cycle Up to 146 Up to $221,920, per replacement cycle. 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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD 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. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the 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 proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 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 Federal Aviation Administration
(FAA)amends § 39.13 by removing amendment 39-15188 (72 FR 51161, September 6, 2007) and adding the following new airworthiness directive (AD): **Avions Marcel Dassault-Breguet Aviation (AMD/BA):** Docket No. FAA-2008-0674; Directorate Identifier 2008-NM-086-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by July 28, 2008. Affected ADs
(b)This AD supersedes AD 2007-18-08. Applicability
(c)This AD applies to all Avions Marcel Dassault-Breguet Model Falcon 10 airplanes, certificated in any category. Unsafe Condition
(d)This AD results from information we received from operators and the airplane manufacturer indicating that the repetitive interval for the required replacement deviated from the referenced service information. We are issuing this AD to prevent collapse of the flexible hoses in the slat anti-icing system, which could lead to insufficient anti-icing capability and, if icing is encountered in this situation, could result in reduced controllability of 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. Certain Requirements of AD 2007-18-08 Hose Replacement
(f)Within 330 flight hours or 7 months after October 11, 2007 (the effective date of AD 2007-18-08), whichever occurs first: Replace the flexible hoses installed in the slat anti-icing system with new hoses having part number (P/N) FAL1007, in accordance with the Accomplishment Instructions of Dassault Service Bulletin F10-313, Revision 1, dated May 10, 2006. Repeat the hose replacement thereafter at intervals not to exceed 700 flight cycles, except as provided by paragraph
(h)of this AD.
(g)Replacement of a hose before October 11, 2007, in accordance with Dassault Service Bulletin F10-313, dated August 10, 2005, is acceptable for compliance with the requirements of paragraph
(f)of this AD. New Requirements of This AD New Repetitive Interval
(h)As of the effective date of this AD, repeat the hose replacement required by paragraph
(f)of this AD within 700 flight hours since the last replacement, or within 100 flight hours after the effective date of this AD, whichever occurs later, and thereafter at intervals not to exceed 700 flight hours. Alternative Methods of Compliance (AMOCs) (i)(1) The Manager, International Branch, ANM-116, FAA, ATTN: Tom Rodriguez, Aerospace Engineer, FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149; has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures 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. Related Information
(j)European Aviation Safety Agency airworthiness directive 2006-0114, dated May 10, 2006, also addresses the subject of this AD. Issued in Renton, Washington, on June 8, 2008. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E8-14575 Filed 6-26-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-143453-05] RIN 1545-BE96 Capital Costs Incurred To Comply With EPA Sulfur Regulations AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking by cross-reference to temporary regulations and notice of public hearing. SUMMARY: In the Rules and Regulations section of this issue of the **Federal Register** , the IRS is issuing temporary regulations under section 179B of the Internal Revenue Code
(Code)relating to the deduction for qualified capital costs paid or incurred by a small business refiner to comply with the highway diesel fuel sulfur control requirements of the Environmental Protection Agency (EPA). The temporary regulations implement changes to the law made by the American Jobs Creation Act of 2004, the Energy Policy Act of 2005, and the Tax Technical Corrections Act of 2007. The text of those temporary regulations also serves as the text of these proposed regulations. This document also provides notice of a public hearing on these proposed regulations. DATES: Written or electronic comments must be received by September 25, 2008. Outlines of topics to be discussed at the public hearing scheduled for October 28, 2008, at 10 a.m. must be received by September 22, 2008. ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-143453-05), room 5203, Internal Revenue Service, PO Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-143453-05), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC, or sent electronically via the Federal eRulemaking Portal at *http://www.regulations.gov* (IRS REG-143453-05). The public hearing will be held in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations, Nicole Cimino,
(202)622-3110; concerning submissions of comments, the hearing, and/or to be placed on the building access list to attend the hearing, Oulwafunmilayo Taylor,
(202)622-7180 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Paperwork Reduction Act The collection of information contained in this notice of proposed rulemaking has been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection of information should be sent to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, SE:W:CAR: MP:T:T:SP, Washington, DC 20224. Comments on the collection of information should be received by August 26, 2008. Comments are specifically requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the IRS, including whether the information will have practical utility; The accuracy of the estimated burden associated with the proposed collection of information; How the quality, utility, and clarity of the information to be collected may be enhanced; How the burden of complying with the proposed collection of information may be minimized, including through the application of automated collection techniques or other forms of information technology; and Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of service to provide information. The collection of information in this proposed regulation is in section 1.179B-1T(d) and section 1.179B-1T(e). This information collected under section 1.179B-1T(d) relates to the election under section 179B(a) by a small business refiner to deduct a portion of the qualified capital costs paid or incurred. The information collected under section 1.179B-1T(e) relates to the election under section 179B(e) by a cooperative small business refiner to allocate all or some of its section 179B(a) deduction to its cooperative owners and to notify those cooperative owners of the allocated amount. This information will be used by the IRS for examination purposes. The collection of information is required to obtain a benefit. The likely respondents are small business refiners. *Estimated total annual reporting burden:* 50 hours. The estimated annual burden per respondent varies from .75 to 1.5 hours, depending on individual circumstances, with an estimated average of 1 hour. *Estimated number of respondents:* 50. *Estimated frequency of responses:* Annually. 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 assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. Background Temporary regulations in the Rules and Regulations section of this issue of the **Federal Register** amend 26 CFR part 1 by adding regulations under section 179B of the Code. The temporary regulations contain rules relating to the deduction provided under section 179B for qualified costs paid or incurred by a small business refiner to comply with the highway diesel fuel sulfur control requirements of the EPA. The text of those temporary regulations also serves as the text of these proposed regulations. The preamble to the temporary regulations explains the temporary regulations and these proposed regulations. Special Analyses It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that the collection of information in these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based upon the fact, as discussed earlier in this preamble, that the amount of time necessary to record and retain the required information is estimated to average one hour for those taxpayers electing to deduct qualified capital costs and electing to allocate all or some of that deduction to certain owners. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, this notice of proposed rulemaking has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Comments and Public Hearing Before these proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight
(8)copies) or electronic comments that are submitted timely to the IRS. The IRS and the Treasury Department specifically request comments on the clarity of the proposed rules and how they may be made easier to understand. All comments will be available for public inspection and copying. A public hearing has been scheduled for October 28, 2008, beginning at 10 a.m. in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. Due to building security procedures, all visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT section of this preamble. The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing must submit written or electronic comments by September 25, 2008 and an outline of the topics to be discussed and the time to be devoted to each topic (signed original and eight
(8)copies) by September 22, 2008. A period of 10 minutes will be allotted to each person for making comments. An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving outlines has passed. Copies of the agenda will be available free of charge at the hearing. Drafting Information The principal author of these regulations is Nicole R. Cimino, Office of Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and the Treasury Department participated in their development. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Proposed Amendments to the Regulations Accordingly, 26 CFR part 1 is proposed to be amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 continues to read in part as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 1.179B-1 is added to read as follows: § 1.179B-1 Deduction for capital costs incurred in complying with Environmental Protection Agency sulfur regulations. [The text of this proposed § 1.179B-1 is the same as the text of § 1.179B-1T published elsewhere in this issue of the **Federal Register** ]. Kevin M. Brown, Deputy Commissioner for Services and Enforcement. [FR Doc. E8-14708 Filed 6-26-08; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-151135-07] RIN 1545-BH39 Multiemployer Plan Funding Guidance; Hearing AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of a public hearing on proposed rulemaking. SUMMARY: This document provides notice of a public hearing on a notice of proposed rulemaking providing additional rules for certain multiemployer defined benefit plans that are in effect on July 16, 2006. These proposed regulations affect sponsors and administrators of, and participants in multiemployer plans that are in either endangered or critical status. These regulations are necessary to implement the new rules set forth in section 432 that are effective for plan years beginning after 2007. The proposed regulations reflect changes made by the Pension Protection Act of 2006. DATES: The public hearing is being held on July 31, 2008, at 10 a.m. The IRS must receive outlines of the topics to be discussed at the hearing by July 10, 2008. ADDRESSES: The public hearing is being held in the auditorium, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. Send submissions to: CC: PA: LPD: PR (REG-151135-07), room 5203, Internal Revenue Service, P. O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC: PA: LPD: PR (REG-151135-07), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayers may submit electronic outlines of oral comments via the Federal eRulemaking Portal at *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Bruce Perlin,
(202)622-6090; concerning submissions of comments, the hearing, and/or to be placed on the building access list to attend the hearing, Richard A. Hurst at *Richard.A.Hurst@irscounsel.treas.gov* or
(202)622-7180 (not toll-free numbers). SUPPLEMENTARY INFORMATION: The subject of the public hearing is the notice of proposed rulemaking (REG-151135-07) that was published in the **Federal Register** on Tuesday, March 8, 2008 (73 FR 14417). Persons who wish to present oral comments at the hearing that submitted written comments must submit an outline of the topics to be discussed and the amount of time to be devoted to each topic (signed original and eight
(8)copies) by July 10, 2008. A period of 10 minutes is allotted to each person for presenting oral comments. After the deadline for receiving outlines has passed, the IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing or in the Freedom of Information Reading Room (FOIA RR) (Room 1621) which is located at the 11th and Pennsylvania Avenue NW., entrance, 1111 Constitution Avenue, NW., Washington, DC. Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT section of this document. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E8-14563 Filed 6-26-08; 8:45 am] BILLING CODE 4830-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2007-0522; FRL-8686-1] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Virginia Major New Source Review for Nonattainment Areas AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule SUMMARY: EPA is proposing limited approval of a State Implementation Plan
(SIP)revision submitted by the Commonwealth of Virginia. This revision pertains to amendments to Virginia's existing new source review permit program for owners of sources located or locating in Nonattainment areas which were submitted to EPA on February 12, 2007. EPA is proposing limited approval of these changes to the nonattainment new source review program, because while the SIP revision submitted by the Commonwealth strengthens the SIP, it does not fully meet the current Federal requirements for the allowable lookback period under the definition of “baseline actual emissions”. EPA is also proposing full approval of a related SIP revision submitted by the Commonwealth on December 16, 2003, pertaining to amendments made to Virginia's existing nonattainment new source review permit program at that time. This action is being taken under the Clean Air Act (CAA or the Act). In a separate action, EPA has addressed changes made by Virginia to its prevention of significant deterioration
(PSD)new source review rules which were previously submitted on October 10, 2006. DATES: Written comments must be received on or before July 28, 2008. ADDRESSES: Submit your comments, identified by Docket ID Number EPA-R03-OAR-2007-0522 by one of the following methods: A. *www.regulations.gov.* Follow the on-line instructions for submitting comments. *B. E-mail: campbell.dave@epa.gov.* C. *Mail:* EPA-R03-OAR-2007-0522, David Campbell, Chief, Permits and Technical Assessment Branch, Mailcode 3AP11, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. D. *Hand Delivery:* At the previously-listed EPA Region III address. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R03-OAR-2007-0522. EPA's policy is that all comments received will be included in the public docket without change, and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the electronic docket are listed in the *www.regulations.gov* index. 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 in *www.regulations.gov* or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Virginia Department of Environmental Quality, 629 East Main Street, Richmond, Virginia, 23219. FOR FURTHER INFORMATION CONTACT: Sharon McCauley,
(215)814-3376, or by e-mail at *mccauley.sharon@epa.gov* . SUPPLEMENTARY INFORMATION: On December 16, 2003 and February 12, 2007, the Commonwealth of Virginia submitted revisions to its SIP for approval of amendments to Virginia's existing new source review
(NSR)permit program for owners of sources locating in nonattainment areas. I. Background On December 31, 2002, the U.S. EPA published revisions to the Federal PSD and nonattainment new source review
(NNSR)regulations (67 FR 80186), effective March 3, 2003. These changes to the Federal NSR regulations were reconsidered with minor changes on November 7, 2003 (68 FR 63021) and collectively, these two final actions are called the “2002 New Source Review
(NSR)Reform Rules”. The 2002 NSR Reform Rules made changes to five areas of the NSR programs. In summary, the 2002 Rules:
(1)Provide a new method for determining the baseline actual emissions;
(2)adopt an actual-to-projected actual methodology for determining whether a major modification has occurred;
(3)allow major stationary sources to comply with plant-wide applicability limits to avoid having a significant emissions increase that triggers the requirements of the major NSR program;
(4)provide a new applicability provision for emissions units that are designated clean units; and
(5)exclude pollution control projects
(PCPs)from the definition of “physical change or change in the method of operation.” The November 7, 2003 notice of final action added a definition for “replacement unit” and clarified an issue regarding the Plant-wide Applicability Limitation
(PALs)baseline calculation procedures for newly constructed units. On June 24, 2005, the United States Court of Appeals for the District of Columbia Circuit ruled in *New York* v. *EPA,* 413 F.3d 3 (DC Cir. June 24, 2005) that EPA lacked the authority to promulgate the Clean Unit provisions, and the Court requested that EPA vacate that portion of the 2002 Federal regulation, codified at 40 CFR 52.21(x), as contrary to the statute. Also, the Court determined that EPA lacked the authority to create PCP exceptions from NSR and vacated those parts of the 1991 and 2002 rules, codified at 40 CFR 52.21(b)(32) and 52.21(z), as contrary to the statute. As stated in the December 31, 2002 “NSR Reform” rulemaking, State and local permitting agencies were required to adopt and submit revisions to their part 51 permitting programs, implementing the minimum program elements of that rulemaking no later than January 2, 2006 (67 FR 80240). With this submittal, Virginia requests approval of program revisions to satisfy this requirement. In addition, Virginia has updated their stationary source permit regulations in Chapter 50, Article 4, to conform to the new NSR regulatory program and translated the Federal NSR requirements into their regulatory text in Chapter 80, Article 9 in a manner that is consistent with State regulatory development procedures. On February 14, 2007, EPA Region III received a revision request to the Virginia SIP from the Virginia Department of Environmental Quality (VADEQ). The February 14, 2007 SIP revision request consisted of changes to Legislative Rule 9 VAC 5 Chapter 50 Article 4—Stationary Sources, 9 VAC 5 Chapter 80 Article 6—Permits for New and Modified Stationary Sources, and 9 VAC 5 Chapter 80 Article 9—Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution which Cause or Contribute to Nonattainment. These rules were adopted by the Commonwealth of Virginia State Air Pollution Control Board on June 21, 2006 and became effective September 1, 2006. The Commonwealth adopted the regulations in order to meet the relevant plan requirements of 40 CFR 51.165. II. Summary of SIP Revision What is being addressed in this document? Virginia currently has an EPA-approved NSR program for new and modified sources. Today, EPA is proposing limited approval of the Virginia pre-construction permitting program as submitted on February 12, 2007 for facilities located or locating in nonattainment areas. This revision submittal consists of rules titled “Chapter 50, Article 4—Stationary Sources”, and “Chapter 80, Article 9—Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution Which Cause or Contribute to Nonattainment” adopted June 21, 2006 and effective September 1, 2006. Virginia also submitted changes to 9 VAC Chapter 80 Article 6—Permits for New and Modified Stationary Sources as part of the SIP revision, however, Article 6 has not previously been approved as part of the Virginia SIP and EPA will not be taking any rulemaking action on this portion of the SIP submittal at this time. Additionally, on December 16, 2003, Virginia submitted a revision to Chapter 80, Article 9 that made a number of changes to comply with the 1990 Amendments to the CAA, the primary of which was to redefine the offset ratio requirements to accommodate the requirements of Subpart I of Part C of Title I of the Act. EPA is proposing full approval of the December 16, 2003 revision submittal. Today's action will revise the previously approved versions of these rules as approved into the Virginia SIP on April 21, 2000 (65 FR 21315) and September 21, 1999 (64 FR 51047), respectively. Copies of the revised Virginia rules and submittal packages, as well as the Technical Support Document (TSD), can be obtained from the Docket as discussed in the “Docket” Section above. A discussion of notable Virginia rule changes that are proposed for inclusion into the SIP are included in the TSD and also summarized below. What are the program changes that EPA is proposing limited approval? In its December 2002 regulatory action, EPA dramatically changed many aspects of the regulations governing the PSD and nonattainment NSR programs (together, as “NSR”), aimed at “providing much needed flexibility and regulatory certainty, and at removing barriers and creating incentives for sources to improve environmental performance through emissions reductions, pollution prevention, and improved energy efficiency.” Virginia accepted the conceptual framework of EPA's NSR reform revisions but tailored the program to their State-specific objectives. EPA agrees that Virginia's regulations, while different in some limited respects, will not prevent companies from benefiting from most, if not all of the goals of NSR reform. In general, EPA has concluded that Virginia's regulations, overall, conform to the minimum program elements in 40 CFR 51.165 despite some variations in their rules from the federal program. It is EPA's position that every element of NSR reform is present in Virginia's rules but these elements may be implemented in a way that allows the Commonwealth more scrutiny with respect to how NSR applies to a facility. The Virginia NSR regulations for nonattainment areas, effective September 1, 2006 are being proposed for limited approval today. The following describes areas within these regulations that vary from the Federal program. Notable Variations in Article 9 From the Federal Program 1. In the EPA regulations, the period used for establishing the baseline for each pollutant can be different for each pollutant. The Virginia regulations require that it be the same for all pollutants, except where extenuating circumstances would allow use of different baseline periods. This variation is acceptable to EPA. 2. The EPA regulations do not specify consequences where the owner determines there is a reasonable possibility that a project that is not a part of a major modification may result in a significant emissions increase and does not obtain a permit. The Virginia regulations specify how the state will act should the owner fail to make an accurate determination. EPA believes that this variation from the federal rule has no impact on approvability or the Commonwealth's ability to achieve the goals of NSR reform and is acceptable to EPA. Please note, the Commonwealth will soon be revising this Section of its regulations to reflect changes made in the EPA final rule dated December 14, 2007 providing improvements to EPA's New Source Review program regarding “reasonable possibility” in recordkeeping. This final rule provided an explanation and more detailed criteria to clarify the “reasonable possibility” recordkeeping and reporting standard of the 2002 New Source Review Reform rule. The improvements provided in the December 14, 2007 rulemaking were to reflect the amendments found necessary to respond to the decision of the U.S. Court of Appeals for the DC Circuit in *New York* v. *EPA,* 413 F.3d 3 (DC Cir. 2005) (New York) which remanded this portion of the December 2002 regulations for EPA to provide an acceptable explanation for its “reasonable possibility” standard or to devise an appropriately supported alternative. 3. The EPA regulations exclude emission increases that could be accommodated and are unrelated to the project, including demand growth, from projected actual emissions. The Virginia regulations included this exclusion but have been revised in order to clarify the intent of the provision and ensure consistency in its application. This variation is acceptable to EPA. 4. The EPA regulations require owners to develop and maintain information to support their determination that a given project is not a part of a major modification that may result in a significant emissions increase. The Virginia regulations require advance notification of the availability of the information prior to beginning actual construction of the project. This variation is acceptable to EPA. 5. The EPA regulations establish Plantwide Applicability Limits
(PALs)with a duration of 10 years; the Virginia regulations contain five-year durations for PALs. This variation is acceptable to EPA. 6. This SIP revision also includes other non-substantive changes to Virginia's Nonattainment New Source Review program. There was a need to update regulatory citations, making consistency revisions to the text to bring the regulations in the Commonwealth up to date. EPA's analysis has found that these non-substantative changes do not change any of the minimum regulatory requirements and are acceptable. Once again, the TSD, (located in the Docket), can be reviewed for an in-depth and full explanation of EPA's regulatory analysis of the Virginia Nonattainment New Source Review program. III. Limited Approval Why is EPA proposing “limited approval” versus “full approval” of Virginia's NSR regulations, effective September 1, 2006 for Nonattainment NSR areas? The Clean Air Act does not expressly provide for limited approvals, therefore EPA is using its gap-filling authority under section 301(a) of the Act in conjunction with the section 110(k)(3) approval provision to interpret the Act to provide for this type of limited approval action. A key aspect of these limited approval actions is that they encompass the entire rule based on the fact that even with limitations, the approval of the entire rule will strengthen the Commonwealth's SIP. The primary advantage to using this limited approval is that it will make the Commonwealth's revision submittal Federally enforceable and will increase the SIP's potential to achieve additional reductions. The following is an explanation for this limited approval of the SIP revision by EPA. In Virginia's regulations under 9 VAC 5-80-2010 a new definition was added to reflect the necessary changes to the program found in the 2002 Federal NSR Reform rule. Virginia's definition for “baseline actual emissions” varies from the Federal definition at 40 CFR 51.166(b)(47) in two ways. First, for both electric generating units
(EGUs)and non-EGUs, Virginia's rule allows the use of different baselines for different pollutants if the owner can demonstrate to the satisfaction of the State Air Pollution Control Board (Board) that a different baseline period for a different pollutant(s) is more appropriate due to extenuating circumstances. This is acceptable to EPA. However in the second instance, for non-EGUs, the 24-month baseline period must occur within the five-year period preceding the date the owner begins actual construction or the permit application is deemed complete, whichever is earlier, unless the Board allows a different time period that it deems is more representative of normal source operations. The allowance of a different or an extended time period by the Board is acceptable as it allows a time period past the more limiting 5-year period, however, the Commonwealth's regulations do not further restrict the Board from allowing a time period which could extend past the 10-year period currently provided in the Federal NSR Reform rule. The Virginia regulations, therefore, meet the general Federal criteria for expanding the lookback period beyond the old requirement of the most recent 24-month period, and are thus equivalent to the Federal requirement. The purpose of an extended lookback is to establish a period that is most representative of source operation. Establishment of the most representative operation not only enables sources to plan effective emissions control strategies, it also provides Virginia with more accurate information on which to base long-term air quality planning strategies. The 5-year lookback period can be seen to be more limiting or at times more restrictive than the Federal rule. Requiring a 5-year lookback instead of a 10-year lookback may, however, limit a source's potential to find a higher baseline. This could in turn restrict a source's ability to emit and is thus inherently more protective than the EPA regulations. As part of the February 12, 2007 SIP revision submittal, the Commonwealth provided a more detailed explanation of the 5-year lookback period. Though it was not Virginia's intention to exceed the 10-year lookback limitation, EPA's decision to propose limited approval is based the Commonwealth's interpretation of its own regulations as provided in their Technical Support Document. EPA is relying on this interpretation of the regulations as noted above and in part, the basis for our limited approval. Furthermore, EPA would look unfavorably upon any use of discretion by Virginia that would allow for baselines that exceed a 10-year lookback period. EPA expects Virginia to correct the definition at 9 VAC 5-80-2010 by limiting the discretionary lookback period to 10 years. When Virginia makes this amendment, they will be eligible for consideration for full approval of its Nonattainment NSR program found in Article 9. IV. Full Approval What is EPA proposing full approval of in this action? On December 16, 2003, the Commonwealth of Virginia submitted a SIP revision submittal for Chapter 80, Article 9 that made a number of changes to comply with the 1990 Amendments to the CAA, the primary of which was to redefine the offset ratio requirements to accommodate the requirements of subpart I of part C of title I of the Act. Additionally, administrative permit processing provisions were also clarified further within this submission. EPA is proposing full approval of the December 16, 2003 revision submittal. V. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information
(1)that are generated or developed before the commencement of a voluntary environmental assessment;
(2)that are prepared independently of the assessment process;
(3)that demonstrate a clear, imminent and substantial danger to the public health or environment; or
(4)that are required by law. On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. * * * ” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Section 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.” Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its NSR program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the Clean Air Act, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law. VI. Proposed Action EPA has determined that the amendments to Virginia's nonattainment new source review permit program at Articles 4 and 9, as submitted on February 12, 2007 meet the minimum requirements of 40 CFR 51.165 and the Clean Air Act. This amendment is being proposed as a limited approval as described in Section III above, as a revision to the Virginia SIP. EPA is also proposing full approval of changes submitted to the nonattainment new source review permit program at Article 9, as submitted on December 16, 2003 and as described in Section IV above as a revision to the Virginia SIP. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action. VII. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action: • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ); • 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); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this proposed rule for limited approval of the SIP revision submitted on February 12, 2007 and the full approval of the SIP revision submitted on December 16, 2003 for facilities located or locating in nonattainment areas for Virginia nonattainment new source review does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. 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. Authority: 42 U.S.C. 7401 *et seq.* Dated: June 17, 2008. William T. Wisniewski, Acting Regional Administrator, Region III. [FR Doc. E8-14625 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2007-0521; FRL-8686-2] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Virginia Major New Source Review, Prevention of Significant Deterioration
(PSD)AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing limited approval of a State Implementation Plan
(SIP)revision submitted by the Commonwealth of Virginia. This revision pertains to amendments to Virginia's existing new source review permit program for owners of sources located or locating in prevention of significant deterioration
(PSD)areas which were submitted to EPA on October 10, 2006. EPA is proposing limited approval of these changes to the PSD program, because while the SIP revision submitted by the Commonwealth strengthens the SIP, it does not fully meet the current Federal requirements for the allowable lookback period under the definition of “baseline actual emissions”. This action is being taken under the Clean Air Act (CAA or the Act). In a separate action, EPA will address changes made by Virginia to its nonattainment new source review
(NNSR)permit program, submitted on February 12, 2007. DATES: Written comments must be received on or before July 28, 2008. ADDRESSES: Submit your comments, identified by Docket ID Number EPA-R03-OAR-2007-0521 by one of the following methods: A. *www.regulations.gov* . Follow the on-line instructions for submitting comments. B. *E-mail: campbell.dave@epa.gov* . C. *Mail:* EPA-R03-OAR-2007-0521, David Campbell, Chief, Permits and Technical Assessment Branch, Mailcode 3AP11, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. D. *Hand Delivery:* At the previously-listed EPA Region III address. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R03-OAR-2007-0521. EPA's policy is that all comments received will be included in the public docket without change, and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the electronic docket are listed in the *www.regulations.gov* index. 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 in *www.regulations.gov* or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Virginia Department of Environmental Quality, 629 East Main Street, Richmond, Virginia 23219. FOR FURTHER INFORMATION CONTACT: Sharon McCauley,
(215)814-3376, or by e-mail at *mccauley.sharon@epa.gov* . SUPPLEMENTARY INFORMATION: On October 10, 2006, the Commonwealth of Virginia submitted a revision to its SIP for approval of amendments to Virginia's existing New Source Review permit program for owners of sources locating in PSD areas. I. Background On December 31, 2002, the U.S. EPA published revisions to the Federal PSD and NNSR regulations (67 FR 80186), effective March 3, 2003. These changes to the Federal NSR regulations were reconsidered with minor changes on November 7, 2003 (68 FR 63021) and collectively, these two final actions are called the “2002 New Source Review
(NSR)Reform Rules”. The 2002 NSR Reform Rules made changes to five areas of the NSR programs. In summary, the 2002 Rules:
(1)Provide a new method for determining the baseline actual emissions;
(2)adopt an actual-to-projected actual methodology for determining whether a major modification has occurred;
(3)allow major stationary sources to comply with plant-wide applicability limits to avoid having a significant emissions increase that triggers the requirements of the major NSR program;
(4)provide a new applicability provision for emissions units that are designated clean units; and
(5)exclude pollution control projects
(PCPs)from the definition of “physical change or change in the method of operation.” The November 7, 2003 notice of final action added a definition for “replacement unit” and clarified an issue regarding the Plant-wide Applicability Limitation
(PALs)baseline calculation procedures for newly constructed units. On June 24, 2005, the United States Court of Appeals for the District of Columbia Circuit ruled in *New York* v. *EPA,* 413 F.3d 3 (DC Cir. June 24, 2005) that EPA lacked the authority to promulgate the Clean Unit provisions, and the Court requested that EPA vacate that portion of the 2002 Federal regulation, codified at 40 CFR 52.21(x), as contrary to the statute. Also, the Court determined that EPA lacked the authority to create PCP exceptions from NSR and vacated those parts of the 1991 and 2002 rules, codified at 40 CFR 52.21(b)(32) and 52.21(z), as contrary to the statute. As stated in the December 31, 2002 “NSR Reform” rulemaking, State and local permitting agencies were required to adopt and submit revisions to their part 51 permitting programs, implementing the minimum program elements of that rulemaking no later then January 2, 2006 (67 FR 80240). With this submittal, Virginia requests approval of program revisions to satisfy this requirement. In addition, Virginia has updated their stationary source permit regulations in Chapter 50, Article 4, to conform to the new NSR regulatory program and translated the Federal NSR requirements into their regulatory text in Chapter 80, Article 8 in a manner that is consistent with State regulatory development procedures. On October 13, 2006, EPA Region III received a revision request to the Virginia SIP from the Virginia Department of Environmental Quality (VADEQ). The October 13, 2006, 2006 SIP revision request consisted of changes to Legislative Rule 9 VAC 5 Chapter 50 Article 4—Stationary Sources, 9 VAC 5 Chapter 80 Article 6—Permits for New and Modified Stationary Sources, and 9 VAC 5 Chapter 80 Article 8—Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration. These rules were adopted by the Commonwealth of Virginia State Air Pollution Control Board on June 21, 2006 and became effective September 1, 2006. The Commonwealth adopted the regulations in order to meet the relevant plan requirements of 40 CFR 51.166. II. Summary of SIP Revision What is being addressed in this document? Virginia currently has an EPA-approved NSR program for new and modified sources. Today, EPA is proposing limited approval of the Virginia pre-construction permitting program as submitted on October 10, 2006 for sources located or locating in PSD areas. The submittal consists of rules titled “Chapter 50, Article 4—Stationary Sources” and “Chapter 80, Article 8—Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration (PSD)” adopted June 21, 2006 and effective September 1, 2006. Virginia also submitted changes to 9 VAC Chapter 80 Article 6—Permits for New and Modified Stationary Sources as part of the SIP revision, however, Article 6 has not previously been approved as part of the Virginia SIP and EPA will not be taking any rulemaking action on this portion of the SIP submittal at this time. This limited approval action will revise the previously-approved versions of these rules as approved into the Virginia SIP on April 21, 2000 (65 FR 21315) and March 23, 1998 (63 FR 13795). Copies of the revised Virginia rules, as well as the Technical Support Document (TSD), can be obtained from the Docket as discussed in the “Docket” Section above. A discussion of the notable Virginia rule changes that are proposed for inclusion into the SIP are included in the TSD and summarized below. What are the program changes that EPA is proposing limited approval? In its December 2002 regulatory action, EPA dramatically changed many aspects of the regulations governing the PSD and nonattainment NSR programs (together, as “NSR”), aimed at providing much needed flexibility and regulatory certainty, and at removing barriers and creating incentives for sources to improve environmental performance through emissions reductions, pollution prevention, and improved energy efficiency.” Virginia accepted the conceptual framework of EPA's NSR reform revisions but tailored the program to their State-specific objectives. EPA agrees that Virginia's regulations, while different in some limited respects, will not prevent companies from benefiting from most, if not all of the goals of NSR reform. In general, EPA has concluded that Virginia's regulations, overall, conform to the minimum program elements in 40 CFR 51.166 despite some variations in their rules from the federal program. These notable variations are described below and the explanation of EPA's proposed limited approval is described in Section III of this notice. Notable Variations in Article 8 From the Federal Program 1. In the EPA regulations, the period used for establishing the baseline for each pollutant can be different for each pollutant. The Virginia regulations require that it be the same for all pollutants, except where extenuating circumstances would allow use of different baseline periods. This variation is acceptable to EPA. 2. The EPA regulations do not specify consequences where the owner determines there is a reasonable possibility that a project that is not a part of a major modification may result in a significant emissions increase and does not obtain a permit. The Virginia regulations specify how the state will act should the owner fail to make an accurate determination. EPA believes that this variation from the Federal rule has no impact on approvability or the Commonwealth's ability to achieve the goals of NSR reform and is acceptable to EPA. Please note, the Commonwealth will soon be revising this Section of its regulations to reflect changes made in the EPA final rule dated December 14, 2007 providing improvements to EPA's New Source Review program regarding “reasonable possibility” in recordkeeping. EPA's final rule provided an explanation and more detailed criteria to clarify the “reasonable possibility” recordkeeping and reporting standard of the 2002 New Source Review Reform rule. The improvements provided in the December 14, 2007 rulemaking were to reflect the amendments found necessary to respond to the decision of the U.S. Court of Appeals for the DC Circuit in *New York* v. *EPA* , 413 F.3d 3 (DC Cir. 2005) (New York) which remanded this portion of the December 2002 regulations for EPA to provide an acceptable explanation for its “reasonable possibility” standard or to devise an appropriately supported alternative. 3. The EPA regulations exclude emission increases that could be accommodated and are unrelated to the project, including demand growth, from projected actual emissions. The Virginia regulations included this exclusion but have been revised in order to clarify the intent of the provision and ensure consistency in its application. This variation is acceptable to EPA. 4. The EPA regulations require owners to develop and maintain information to support their determination that a given project is not a part of a major modification that may result in a significant emissions increase. The Virginia regulations require advance notification of the availability of the information prior to beginning actual construction of the project. This variation is acceptable to EPA. 5. The EPA regulations establish Plantwide Applicability Limits
(PALs)with a duration of 10 years; the Virginia regulations contain five-year durations for PALs. This variation is acceptable to EPA. 6. This SIP revision also includes other non-substantive changes to Virginia's PSD program. There was a need to update regulatory citations, making consistency revisions to the text to bring the regulations in the Commonwealth up to date. EPA's analysis has found that these non-substantative changes do not change any of the minimum regulatory requirements and are acceptable. For an in-depth and full explanation of EPA's regulatory analysis of the Virginia PSD program, please review the TSD located in the Docket. EPA's position is that every element of NSR reform is present in Virginia's rules but some elements may be implemented in a way that allows the Commonwealth more scrutiny with respect to how NSR applies to a facility. III. Limited Approval Why is EPA proposing “limited approval” versus “full approval” of Virginia's NSR Reform regulations for PSD areas? The Clean Air Act does not expressly provide for limited approvals, therefore EPA is using its gap-filling authority under section 301
(a)of the Act in conjunction with the section 110(k)(3) approval provision to interpret the Act to provide for this type of limited approval action. A key aspect of these limited approval actions is that they encompass the entire rule based on the fact that even with limitations, the approval of the entire rule will strengthen the Commonwealth's SIP. The primary advantage to using this limited approval is that it will make the Commonwealth's revision submittal Federally enforceable and will increase the SIP's potential to achieve additional reductions. The following is an explanation for the limited approval of this SIP revision by EPA. In Virginia's regulations under 9 VAC 5-80-1615 a new definition was added to reflect the necessary changes to the program found in the 2002 Federal NSR Reform rule. Virginia's definition for “baseline actual emissions” varies from the Federal definition at 40 CFR 51.166(b)(47) in two ways. First, for both electric generating units
(EGUs)and non-EGUs, Virginia's rule allows the use of different baselines for different pollutants if the owner can demonstrate to the satisfaction of the State Air Pollution Control Board (Board) that a different baseline period for a different pollutant(s) is more appropriate due to extenuating circumstances. This is acceptable to EPA. However in the second instance, for non-EGUs, the 24-month baseline period must occur within the five-year period preceding the date the owner begins actual construction or the permit application is deemed complete, whichever is earlier, unless the Board allows a different time period that it deems is more representative of normal source operations. The allowance of a different or an extended time period by the Board is acceptable as it allows a time period past the more limiting 5-year period; however, the Commonwealth's regulations do not further restrict the Board from allowing a time period which could extend past the 10-year period currently provided in the federal NSR Reform rule. The Virginia regulations, therefore, meet the general federal criteria for expanding the lookback period beyond the old requirement of the most recent 24-month period, and are thus equivalent to the federal requirement. The purpose of an extended lookback is to establish a period that is most representative of source operation. Establishment of the most representative operation not only enables sources to plan effective emissions control strategies, it also provides Virginia with more accurate information on which to base long-term air quality planning strategies. The 5-year lookback period can be seen to be more limiting or at times more restrictive than the Federal rule. Requiring a 5-year lookback instead of a 10-year lookback may, however, limit a source's potential to find a higher baseline. This could in turn restrict a source's ability to emit and is thus inherently more protective than the EPA regulations. As part of the October 10, 2006 SIP revision submittal, the Commonwealth provided a more detailed explanation of the 5-year lookback period. Though it was not Virginia's intention to exceed the 10-year lookback period limitation, EPA's decision to propose limited approval is based on the Commonwealth's interpretation of its own regulations as provided in their Technical Support Document. EPA is relying on this interpretation of the regulations as noted above and in part, the basis for our limited approval. Furthermore, EPA would look unfavorably upon any use of discretion by Virginia that would allow for baselines that exceed a 10-year lookback period. EPA expects Virginia to correct the definition at 9 VAC 5-80-1615 by limiting the discretionary lookback period to 10 years. When Virginia makes this amendment, they will be eligible for consideration for full approval of its PSD program found in Article 8. IV. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information
(1)that are generated or developed before the commencement of a voluntary environmental assessment;
(2)that are prepared independently of the assessment process;
(3)that demonstrate a clear, imminent and substantial danger to the public health or environment; or
(4)that are required by law. On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law”, including documents and information “required by Federal law to maintain program delegation, authorization or approval, since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts “* * *.” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.” Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity. Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its PSD program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the Clean Air Act, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by this, or any, state audit privilege or immunity law. V. Proposed Action EPA has determined that the amendments to Virginia's PSD permit program at Articles 4 and 8, as submitted on October 10, 2006 meet the minimum requirements of 40 CFR 51.166 and the Clean Air Act. This amendment is being proposed as a limited approval to the Virginia SIP. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action. VI. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action: • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ); • 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); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this proposed rule for limited approval of the Virginia Major New Source review Reform for facilities located or locating in PSD areas does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. 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. Authority: 42 U.S.C. 7401 *et seq.* Dated: June 17, 2008. William T. Wisniewski, Acting Regional Administrator, Region III. [FR Doc. E8-14617 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2007-0998; FRL-8684-2] Approval and Promulgation of State Implementation Plans: Washington; Vancouver Air Quality Maintenance Area; Second 10-Year Carbon Monoxide Maintenance Plan AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a State Implementation Plan
(SIP)revision submitted by the State of Washington. The Washington State Department of Ecology submitted the Vancouver Air Quality Maintenance Area Second 10-year Carbon Monoxide Maintenance Plan on April 25, 2007. In accordance with the requirements of the Federal Clean Air Act (the Act), EPA is proposing to approve Washington's revision because the State adequately demonstrates that the Vancouver Air Quality Maintenance Area will maintain air quality standards for carbon monoxide
(CO)through the year 2016. DATES: Comments must be received on or before July 28, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-OAR-2007-0998, by any of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: vaupel.claudia@epa.gov.* • *Mail:* Claudia Vergnani Vaupel, U.S. EPA Region 10, Office of Air, Waste and Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA 98101. • *Hand Delivery/Courier:* U.S. EPA Region 10, 1200 Sixth Avenue, Suite 900, Seattle, WA 98101. Attention: Claudia Vergnani Vaupel, Office of Air, Waste and Toxics, AWT-107. Such deliveries are only accepted during normal hours of operation, and special arrangements should be made for deliveries of boxed information. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Claudia Vergnani Vaupel at telephone number:
(206)553-6121, e-mail address: *vaupel.claudia@epa.gov* , fax number:
(206)553-0110, or Gina Bonifacino at telephone number:
(206)553-2970, e-mail address: *bonifacino.gina@epa.gov* , or the above EPA, Region 10 address. SUPPLEMENTARY INFORMATION: For further information, please see the direct final action, of the same title, which is located in the Rules section of this **Federal Register** . EPA is approving the State's SIP revision as a direct final rule without prior proposal because EPA views this as a noncontroversial SIP revision and anticipates no adverse comments. A detailed rationale for the approval is set forth in the preamble to the direct final rule. If EPA receives no adverse comments, EPA will not take further action on this proposed rule. If EPA receives adverse comments, EPA will withdraw the direct final rule and it will not take effect. EPA will address all public comments in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. Dated: June 10, 2008. Michelle Pirzadeh, Acting Regional Administrator, EPA Region 10. [FR Doc. E8-14519 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2006-0040; FRL-8685-9] Approval, Disapproval, and Promulgation of Air Quality Implementation Plans; Montana; Kraft Pulp Mill Rule AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to partially approve and partially disapprove the Kraft Pulp Mill Rule and Visible Air Contaminants Rule that the Governor of Montana submitted to us on April 14, 1999. EPA is also proposing to partially approve the recodification of the Kraft Pulp Mill Rule that the Governor submitted to us on September 19, 1997. These revisions recodify and make changes to the State's Kraft Pulp Mill Rule, including the establishment of certain new opacity requirements for kraft pulp mills, and modify the Visible Air Contaminant Rule requirements for recovery furnaces at kraft pulp mills. The intended effect of this action is to approve and make federally enforceable those portions of the rules that meet Clean Air Act requirements, and to disapprove those portions of the rules that are inconsistent with the Clean Air Act. The EPA is taking this action under section 110 of the Clean Air Act (Act). DATES: Comments must be received on or before July 28, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-OAR-2006-0040, by one of the following methods: • *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *E-mail: videtich.callie@epa.gov* and *russ.tim@epa.gov* . • *Fax:*
(303)312-6064 (please alert the individual listed in FOR FURTHER INFORMATION CONTACT if you are faxing comments). • *Mail:* Callie A. Videtich, Director, Air Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129. • *Hand Delivery:* Callie A. Videtich, Director, Air Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129. Such deliveries are only accepted Monday through Friday, 8 a.m. to 4:30 p.m., excluding Federal holidays. Special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R08-OAR-2006-0040. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA, without going through *http://www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm* . For additional instructions on submitting comments, go to section I. General Information of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the Air Program, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street, Denver, Colorado 80202-1129. EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8 a.m. to 4 p.m., excluding Federal holidays. FOR FURTHER INFORMATION CONTACT: Tim Russ, Air Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street, Denver, Colorado 80202-1129,
(303)312-6479, or russ.tim@epa.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. General Information II. Background of the State Submittals III. EPA Analysis of the State Submittals IV. Proposed Action V. Statutory and Executive Order Reviews *Definitions* For the purpose of this document, we are giving meaning to certain words or initials as follows:
(i)The word *Act* or initials *CAA* mean or refer to the Clean Air Act, unless the context indicates otherwise.
(ii)The words *EPA, we, us* or *our* mean or refer to the United States Environmental Protection Agency.
(iii)The initials *NAAQS* means National Ambient Air Quality Standard.
(iv)The initials *SIP* mean or refer to State Implementation Plan.
(v)The words *State* or *Montana* mean the State of Montana, unless the context indicates otherwise. I. General Information a. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI.* Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for Preparing Your Comments.* When submitting comments, remember to: A. Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). B. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. C. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. D. Describe any assumptions and provide any technical information and/or data that you used. E. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. F. Provide specific examples to illustrate your concerns, and suggest alternatives. G. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. H. Make sure to submit your comments by the comment period deadline identified. II. Background of the State Submittals On April 14, 1999 the Governor of Montana submitted a SIP revision that contained changes to the State's Kraft Pulp Mill Rule, Visible Air Contaminant Rule, and Incorporation by Reference Rule that had been adopted by the Montana Board of Environmental Review
(MBER)on May 19, 1995 and December 11, 1998 1 . Montana's Kraft Pulp Mill Rule, currently codified at ARM 17.8.321, applies to only one source, Smurfit-Stone Container in Missoula, Montana. The SIP revision changes opacity limits at Smurfit-Stone Container's recovery furnaces #3, #4, and #5, as described more fully below. 1 On August 13, 2001 (66 FR 42427), we approved the changes to the Incorporation by Reference Rule (ARM 17.8.302) that MBER adopted on May 19, 1995; no further discussion of the Incorporation by Reference Rule is included in this action. a. MBER's May 19, 1995 Revisions The revisions MBER adopted on May 19, 1995 added definitions for “cross recovery furnace,” “recovery furnace,” and “straight kraft recovery furnace,” (ARM 16.8.1413(1)(b),
(f)and (h)); made minor revisions to ARM 16.8.1413(7); and added ARM 16.8.1413(8) through (12). 2 ARM 16.8.1413(8) through
(12)contained opacity limits on recovery furnaces as well as the compliance monitoring methods for the opacity limitations and reporting requirements. The revised rule resulted in a 35% opacity limit on recovery furnace #3 and a 30% opacity limit on recovery furnaces #4 and #5. The revised rule also required Smurfit-Stone to install continuous opacity monitors
(COMS)on the three recovery furnace stacks. Additionally, on May 19, 1995, the MBER adopted a new provision (ARM 16.8.1404(4)(f) later recodified as ARM 17.8.304(4)(f) and submitted to us on September 19, 1997 3 ), which provided that Montana's general opacity requirements in ARM 16.8.1404 did not apply to recovery furnaces at kraft pulp mills. These general opacity requirements require sources installed on or before November 23, 1968 to meet a 40% opacity limitation and sources installed after November 23, 1968 to meet a 20% opacity limitation. 2 These rules were later recodified; ARM 16.8.1413(1) through
(12)were changed to ARM 17.8.321(1) through (12). This recodification was submitted to us on September 19, 1997 as part of a general recodification of Montana's air rules. 3 In a separate rulemaking action published on August 13, 2001 (66 FR 42427), we approved most of the recodification of the Administrative Rules of Montana submitted on September 19, 1997. We did not approve the codification of ARM 17.8.321, Kraft Pulp Mill Rule, or ARM 17.8.304(4)(f) of the Visible Air Contaminants Rule. In our August 13, 2001 action, we indicated that we would address the revisions to ARM 17.8.304(4)(f) and 17.8.321 at a later date. b. MBER's December 11, 1998 Revisions On December 11, 1998, MBER adopted further changes and additions to the Kraft Pulp Mill Rule, including changes to the May 1995 opacity limits applicable to recovery furnaces #4 and #5. These changes and additions were codified at ARM 17.8.321(9) through (16). ARM 17.8.321(9) (applicable to recovery furnace #4) requires that, for recovery furnaces installed after November 23, 1968, no person may cause or authorize emissions that exhibit 20% opacity or greater averaged over 6 consecutive minutes for more than 6% of the 6-minute time periods during which a source is operating in a calendar quarter. ARM 17.8.321(10) (applicable to recovery furnace #5) requires that, for recovery furnaces installed after September 4, 1976, no person may cause or authorize emissions that exhibit 20% opacity or greater averaged over 6 consecutive minutes for more than 3% of the 6-minute time periods during which a source is operating in a calendar quarter. ARM 17.8.321(11) defines excess opacity emissions. ARM 17.8.321(12) indicates that sources subject to ARM 17.8.321(9) and
(10)may not emit opacity greater than 20% averaged over 24 hours. ARM 17.8.321(13) requires recovery furnaces and associated air pollution control equipment to be operated in accordance with good air pollution control practices during excess opacity emissions. Finally, ARM 17.8.321(14), (15), and
(16)contain revisions to the compliance monitoring methods and reporting requirements for kraft pulp mills. III. EPA Analysis of the State Submittals a. ARM 17.8.321(1) Through (7), Adopted May 19, 1995, Effective August 11, 1995, and Submitted April 14, 1999 The State merely added definitions, made editorial changes, and recodified the rule. Because the changes are consistent with Clean Air Act requirements, we are proposing to approve into the SIP ARM 17.8.321(1) through
(7)(formerly codified as ARM 16.8.1413(1) through (7)). We are also proposing that ARM 17.8.321(1) through
(7)will replace the old codified version of the Kraft Pulp Mill Rule (ARM 16.8.1413(1) through (7), effective December 31, 1972) that is currently in the SIP. b. ARM 17.8.321(8), Adopted May 19, 1995, Effective August 11, 1995, Submitted April 14, 1999; and ARM 17.8.321(9) and (10), Adopted December 11, 1998, Effective February 12, 1999, and Submitted April 14, 1999 The table below shows the opacity limits in ARM 17.8.321(8),
(9)and
(10)as compared to the existing SIP opacity limits for Smurfit-Stone's three recovery furnaces. Smurfit-Stone recovery furnace impacted Installation date Opacity limit six-minute average (existing SIP-Approved rule, ARM 17.8.304) Opacity limit *** six-minute average (revised rule, ARM 17.8.321) Exceedance allowance with revised rule Furnace #3 On or before 11/23/68 40% * ARM 17.8.304(1) 35% ARM 17.8.321(8) None. Furnace #4 After 11/23/68 20% * ARM 17.8.304(2) 20% ARM 17.8.321(9) **** 6% of the 6-minute periods during which a source is operating within any calendar quarter. Furnace #5 After 9/4/76 35% ** ARM 17.8.304(4) 20% ARM 17.8.321(10) **** 3% of the 6-minute periods during which a source is operating within any calendar quarter. * Sources not allowed to exceed opacity limit except a maximum opacity of 60% is permissible for not more than one 4-minute period in any 60 consecutive minutes during the building of new fires, cleaning of grates, or soot blowing (ARM 17.8.304(3)). ** ARM 17.8.304(4)(d) indicates that the 20% opacity standard in ARM 17.8.304(2) does not apply to “those new stationary sources listed in ARM 17.8.340 for which a visible emission standard has been promulgated.” ARM 17.8.340 cross-references EPA's New Source Performance Standards (NSPS). Under the State's interpretation, Furnace #5 is thus subject to the NSPS opacity standard for kraft pulp mills instead of the 20% SIP standard. The NSPS opacity standard is 35% with a 6% quarterly exceedance allowance. See 40 CFR 60.284(d) and (e). *** Sources not allowed to exceed opacity limit except for any exceedance allowance. **** ARM17.8.321(12) contains an additional requirement that applies to recovery furnaces #4 and #5: Opacity of 20% or greater as averaged over 24 hours is not permitted. Among other things, EPA evaluates SIP revisions against section 110(l) of the Act. Section 110(l) of the Act provides that we cannot approve a revision to a SIP if the revision would interfere with any applicable requirements concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the Act. Our evaluation of the changes to ARM 17.8.321(8), (9), and
(10)with respect to section 110(l) of the Act is as follows: 1. *ARM 17.8.321(8):* We are proposing to approve ARM 17.8.321(8) because it does not contain an opacity exceedance allowance and it imposes a more stringent opacity limit than the existing SIP on recovery furnaces installed on or before November 23, 1968. Thus, no increase in particulate matter emissions is expected from this change. Accordingly, this revision would not interfere with any applicable requirements concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the Act. However, we are concerned that the second sentence of ARM 17.8.321(8), which applies to Smurfit-Stone recovery furnace #3, could be read more broadly than is appropriate. That sentence indicates that the opacity limit in ARM 17.8.321(8) “supersedes any other opacity limitation contained in this chapter, including ARM 17.8.304 and 17.8.340.” ARM 17.8.340 requires compliance with the New Source Performance Standards
(NSPS)in 40 CFR part 60. In our view, a SIP rule cannot “supersede” a federal standard such as the NSPS; instead, the NSPS is another requirement that may apply to a source. A source is obligated to comply with the SIP's opacity provisions for recovery furnaces and the NSPS. Accordingly, we note that while ARM 17.8.321(8) states that its opacity limit supersedes “any other opacity limitation contained in this chapter” (emphasis added), it does not say that its opacity limit supersedes the federally-established opacity limits contained in 40 CFR Part 60. Thus, it is our interpretation that ARM 17.8.321(8) does not supersede the requirements of 40 CFR Part 60; instead, we interpret ARM 17.8.321(8) as establishing an additional standard. To the extent ARM 17.8.321(8) and 40 CFR Part 60 are both applicable, the source must comply with both. In this case, because ARM 17.8.321(8) is more stringent than the current NSPS opacity standards applicable to kraft pulp mill recovery furnaces, compliance with ARM 17.8.321(8) should ensure compliance with the NSPS opacity standard. 2. *ARM 17.8.321(9):* We are proposing to disapprove ARM 17.8.321(9). Although the opacity limit of 20% in ARM 17.8.321(9) is the same numeric opacity limit that is contained in the approved SIP, ARM 17.8.321(9) contains an exceedance allowance that is not in the approved SIP. The exceedance allowance allows the source to exceed its opacity limit a certain percentage of time each quarter; in ARM 17.8.321(9), the exceedence allowance is 6% of the 6-minute time periods during which the source is operating. While the source is also subject to an average daily opacity limit of 20%, per ARM 17.8.321(12), our analysis indicates that even with this restriction, the opacity limit in ARM 17.8.321(9) would be less stringent than the existing SIP opacity limit (which is based on a six-minute average, not daily) and could lead to an increase in particulate matter emissions, as calculated using the source-supplied correlation between opacity and particulate matter. Our analysis considers potential effects on attainment of the PM <sup>10</sup> and PM <sup>2.5</sup> NAAQS and compliance with the PM <sup>10</sup> increment under the Clean Air Act's Prevention of Significant Deterioration
(PSD)provisions. Regarding the PM <sup>10</sup> NAAQS, we note that the PM <sup>10</sup> limit on Smurfit-Stone recovery furnace #4 was relied on to help demonstrate attainment of the PM <sup>10</sup> NAAQS in Missoula County, Montana. Therefore, to show compliance with the requirements of section 110(l) of the CAA, it would be necessary to demonstrate that the revision to the opacity limit would not interfere with continued attainment of the PM <sup>10</sup> NAAQS and that the PM <sup>10</sup> limits on recovery furnace #4 would be met during the exceedance allowance, assuming the 20% restriction on the average daily opacity contained in ARM 17.8.321(12). 4 4 Opacity has long been used as an indicator of compliance with emission limits; if opacity increases, PM emissions are also likely to increase. 40 CFR 51.212 requires that SIPs include opacity limits as a means to detect violations of rules and regulations. Similarly, the NSPS imposes opacity limits but provides the option for sources to petition EPA for a higher opacity limit if the source can show that it complied with all other applicable limits during performance tests under 40 CFR 60.8 but failed to meet its opacity limit. *See* 40 CFR 60.11(e)(6). Our concern is that a relaxation in the kraft pulp mill opacity limit could result in undetected exceedances of the particulate emission limits if compliance with the opacity limit would not necessarily reflect compliance with the PM limits. Relative to this issue, the Montana Department of Environmental Quality
(MDEQ)provided testimony to the MBER for its proposed revisions to the Kraft Pulp Mill Rule. In its testimony, the MDEQ attempted to show the effect of an opacity exceedance allowance on the PM <sup>10</sup> mass emissions for Smurfit-Stone's recovery furnace #4. The MDEQ concluded that the mass emissions allowed by the State's proposed changes to the Kraft Pulp Mill Rule would be comparable to those allowed by the current SIP. In order to make this comparison, the MDEQ assumed the average opacity during use of the exceedance allowance would not exceed the 20% standard by more than 10%; thus, 30% was the estimated average opacity during exceedance periods. Additionally, MDEQ estimated particulate emissions using a correlation equation developed by Smurfit-Stone 5 and assuming average air flow to the recovery furnaces. 5 Smurfit-Stone has conducted studies to correlate particulate emissions with opacity readings at recovery furnaces #4 and #5, and the resulting correlation equations are used to determine compliance with particulate limits at recovery furnaces #4 and #5. We believe this approach is flawed for two reasons. First, during Smurfit-Stone's use of the exceedance allowance, the Kraft Pulp Mill Rule does not limit exceedances to 30% opacity; thus, capping the exceedances at 30% is expected to underestimate the predicted particulate emissions. Second, using average, rather than maximum, air flow to the recovery furnaces may also underestimate predicted particulate emissions. Any demonstration to show that the PM <sup>10</sup> emission limits, and hence the PM <sup>10</sup> NAAQS, would be met should use worst-case scenarios. Using worst case scenarios, EPA conducted its own analysis of potential PM <sup>10</sup> emissions from recovery furnace #4. Like MDEQ, we used Smurfit-Stone's correlation equation for recovery furnace #4. However, we used worst-case assumptions for air flow and opacity levels. Smurfit-Stone's furnace-specific correlation equation is used by Smurfit-Stone and the State to calculate particulate emissions from the furnace and is based on the opacity of furnace emissions and air flow to the furnace. According to the State, the equation is as follows: *Recovery Furnace #4:* Particulate emissions (pounds/day) = Q*C*K1*K2 Where: Q = stack exit air flow in dry standard cubic feet per minute (DSCFM) = 0.2322*(total air) + 14637 (total air = air flow into the boiler (pounds/hour)); C = particulate concentration in grains/dry standard cubic foot
(DSCF)= (−0.1303*ln(1−opacity)) + 0.0008; opacity represented as a decimal (10% opacity would be 0.10 in this equation); K1 = conversion factor (1 pound/7000 grains); and K2 = conversion factor (1440 minutes/day). In our analysis, we relied on the following considerations: With a 6% per quarter exceedance allowance, recovery furnace #4 could exceed the 20% opacity limit up to approximately 131 hours per quarter (8760 hours per year/4 quarters per year * 6 % = 131 hours per quarter.) Thus, for a single 24 hour period, recovery furnace #4 could exceed the 20% opacity limit every six-minute period during the 24 hour period and still have the ability to comply with its exceedance allowance for the quarter. This means that, on a 24-hour basis, ARM 17.8.321(12)'s 20% daily average opacity limit for recovery furnace #4 is more controlling than the exceedance allowance. Accordingly, in our analysis we attempted to determine whether compliance with the 20% daily average opacity limit would ensure compliance with the daily particulate emission limits at recovery furnace #4. Using the correlation equation, potential opacity readings, and maximum gas flow rate, we found that meeting the 20% daily average opacity limit would not assure that the 24-hour PM 10 emission limits on recovery furnace #4 would be met. Our analysis is contained in the docket to this action. In addition, the State did not provide us with any basis for concluding that increases in PM 2.5 emissions would not interfere with attainment of the PM 2.5 NAAQS, and that increases in PM 10 emissions would not jeopardize the PM 10 increment. 6 Based on the State's submittal and our own evaluation, we are unable to conclude that the revision in ARM 17.8.321(9) would not interfere with attainment of the PM 10 and PM 2.5 NAAQS or jeopardize the PM 10 increment. Thus, we are proposing to disapprove ARM 17.8.321(9). 6 In a September 25, 1998 letter to the State, we indicated that an evaluation of the impact on the PM 10 increment must occur because a relaxation of the opacity limit could result in increases in actual emissions from the source. 40 CFR 51.166(a)(2), states “If a SIP revision would result in increased air quality deterioration over any baseline concentration, the plan revision shall include a demonstration that it will not cause or contribute to a violation. 3. *ARM 17.8.321(10):* Because the 20% opacity limit in ARM 17.8.321(10) is more stringent than the 35% opacity limit in the approved SIP, and ARM 17.8.321(10)'s exceedance allowance (3% per quarter) is more stringent than the existing SIP rule's exceedance allowance (6% per quarter), we are proposing to approve ARM 17.8.321(10). No increase in particulate matter emissions is expected from this change. Thus, this revision would not interfere with any applicable requirements concerning attainment and reasonable further progress (RFP), or any other applicable requirement of the Act. c. ARM 17.8.321(11) Through
(16)ARM 17.8.321(11) indicates that excess opacity emissions for recovery furnaces installed on or before November 23, 1968 means any 6-minute average of 35% or greater and for recovery furnaces installed after November 23, 1968 means any 6-minute average of 20% or greater. ARM 17.8.321(12) indicates that for recovery furnaces subject to ARM 17.8.321(9) and (10), no person may cause or allow emissions that exhibit a 20% opacity or greater as averaged over a 24-hour period. ARM 17.8.321(13) requires recovery furnaces and associated air pollution control equipment to be operated in accordance with good air pollution control practices during any period of excess opacity emissions. Finally, ARM 17.8.321(14), (15), and
(16)require recovery furnaces subject to ARM 17.8.321(8), (9), and
(10)to install and operate COMS pursuant to certain requirements, and to report excess opacity emissions. We note that ARM 17.8.321(15) indicates that COMS will be the primary measure of compliance with the opacity limits in the rule, but that EPA Method 9 may be used as a measure of compliance when there is a reason to believe the COMS data are not accurate or when COMS data are unavailable. We do not believe this language was intended to preclude the use of Method 9 readings as credible evidence of compliance in circumstances other than those specified in the rule, and we propose to interpret the rule accordingly. Because the above provisions will not reduce the stringency of the existing federally-approved SIP, we consider them to be consistent with the requirements of section 110(l) of the Act. Therefore, we are proposing to approve ARM 17.8.321(11) through (16). d. ARM 17.8.304(4)(f) As part of the April 14, 1999 submittal to us, the Governor submitted revisions to ARM 17.8.304, the Visible Air Contaminants Rule. On May 19, 1995, MBER added subsection
(f)to ARM 16.8.1404(4) (now codified as ARM 17.8.304(4)(f)). ARM 17.8.304(4)(f) excludes recovery furnaces at kraft pulp mills from the statewide general opacity requirements. We are proposing to disapprove the addition of this paragraph because we are proposing to disapprove ARM 17.8.321(9). If we were to approve the addition of paragraph (4)(f), and disapprove the State's new opacity requirements in ARM 17.8.321(9), kraft pulp mill recovery furnaces installed between November 23, 1968 and September 4, 1976 would not be subject to any EPA-approved SIP opacity limits. IV. Proposed Action We are proposing action on the revisions to ARM 17.8.304, “Visible Air Contaminants,” and ARM 17.8.321, “Kraft Pulp Mill Rule,” that the Governor of Montana submitted to us on April 14, 1999, and on the recodification of the Kraft Pulp Mill Rule that the Governor submitted to us on September 19, 1997. We are proposing to approve the recodification of, and revisions to, the Kraft Pulp Mill Rule found in ARM 17.8.321(1) through
(7)(formerly codified ARM 16.8.1413(1) through (7)). We are also proposing that ARM 17.8.321(1) through (7), if approved, will replace the old codified version of the Kraft Pulp Mill Rule (ARM 16.8.1413(1) through (7), effective December 31, 1972) that is currently in the SIP. We are also proposing to approve the provisions in ARM 17.8.321(8) and
(10)through (16). We are proposing to disapprove the provisions of the Kraft Pulp Mill Rule found in ARM 17.8.321(9). We are also proposing to disapprove ARM 17.8.304(4)(f). EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before we take final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to us as discussed in prior sections of this proposed rule. V. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed 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 proposed action merely proposes to approve and disapprove state law as meeting and not meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed 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 proposes to approve and disapprove pre-existing requirements under state law 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 proposed 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 proposes to approve and disapprove portions of a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed 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 Clean Air Act. 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 Clean Air Act. 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 proposed 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.* ). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements. Authority: 42 U.S.C. 7401 *et seq.* Dated: June 4, 2008. Carol Rushin, Deputy Regional Administrator, Region 8. [FR Doc. E8-14622 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383, 384, 390, and 391 [Docket No. FMCSA-1997-2210] RIN 2126-AA10 Medical Certification Requirements as Part of the Commercial Driver's License; Availability of Supplemental Document AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Proposed rule; availability of supplemental document. SUMMARY: This notice advises the public that FMCSA is placing in the public docket an additional document that the Agency may rely on in support of a final rule to integrate information regarding the medical certification status of a driver into the commercial driver's license
(CDL)process. FMCSA published a notice of proposed rulemaking
(NPRM)on this matter on November 16, 2006. Because the involved state cost analysis document was completed after publication of the NPRM and subsequent public comment period, the Agency now dockets and invites comment on it. DATES: Comments on the document are due by July 28, 2008. ADDRESSES: You may submit comments, identified by docket number FMCSA-1997-2210, by one of the following methods: Internet, facsimile, regular mail, or hand delivery. Please do not submit the same comments by more than one method. FMCSA encourages use of the Federal eRulemaking portal. It provides the most efficient and timely method of receiving and processing your comments. • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the online instructions for submitting comments. • *Fax:* 1-202-493-2251. • *Mail:* Docket Management Facility; U.S. Department of Transportation; 1200 New Jersey Avenue, SE.; Washington, DC 20590-0001. • *Hand Delivery:* Ground floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and5 p.m., e.t., Monday through Friday, except Federal holidays. *Instructions:* All submissions must include the Agency name and docket number (FMCSA-1997-2210) or Regulatory Identification Number (RIN 2126-AA10) for this action. Note that all comments received will be posted without change to *http://www.regulations.gov* , including any personal information provided. Refer to the Privacy Act heading at *http://www.regulations.gov* for further information. *Privacy Act:* Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19476) or you may visit *http://DocketsInfo.dot.gov.* *Submitting Comments:* • You can find electronic submission and retrieval help and guidelines under the “help” section of the Web site. • For notification that FMCSA received your comments, please include a self-addressed, stamped envelope or postcard, or print the acknowledgement page that appears after submitting comments on line. • All comments received before the close of business on the comment closing date indicated above will be considered and will be available for examination in the docket at the above address or on the Web site. • Comments received after the comment closing date will be available in the docket and will be considered to the extent it is practical. FMCSA will continue to put relevant information in the docket as it becomes available after the comment period closing date, and interested persons should continue to examine the docket for new material. FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical Programs, FMCSA, Room W64-224, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001. Telephone:
(202)366-4001. E-mail address: *FMCSAMedical@dot.gov.* Office hours are from 8:30 a.m. to 5 p.m. Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: On November 16, 2006, FMCSA published an NPRM on how the Agency proposes to integrate information regarding the medical certification status of a driver of a commercial motor vehicle into the CDL process (71 FR 66723). This rulemaking is required by section 215 of the Motor Carrier Safety Improvement Act of 1999 (MCSIA) (Pub. L. 106-159, 113 Stat. 1767, December 9, 1999; set out as a note to 49 U.S.C. 31305). For a full explanation of this proposal, please see the preamble to the NPRM. The docket for this rulemaking (FMCSA-1997-2210) contains the NPRM and all of the background information for this rulemaking, including comments. This notice calls attention to an additional docketed document which was not used in developing the NPRM that FMCSA may rely on in support of its final rule. Placing this document in the docket now is necessary because it only became available after the NPRM was published and after conclusion of the comment period established in the NPRM. The Agency has placed the state cost analysis document referenced below in the docket for this rulemaking and will accept comments on this document until July 28, 2008. The document that FMCSA is placing in the docket is titled: State Cost Analysis to Implement Notice of Proposed Rulemaking
(NPRM)dated November 16, 2006 titled “Medical Certification Requirements as Part of the CDL,” prepared for the U.S. Department of Transportation by the North American Driver Safety Foundation, October 2007. Several States asserted in their comments to the NPRM that they believe the Agency underestimated State costs for complying with the proposed rule. They requested FMCSA to gather additional data from States on the anticipated costs for this proposal. In response, the Agency arranged to survey a sample of nine States to evaluate whether the costs to States to implement this rule would be different than those used in the NPRM. This report describes what cost information was collected and how that additional cost information was analyzed to better estimate the national costs of implementing the requirements outlined in the NPRM. Issued on: June 20, 2008. John H. Hill, Administrator. [FR Doc. E8-14608 Filed 6-26-08; 8:45 am] BILLING CODE 4910-EX-P 73 125 Friday, June 27, 2008 Notices COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Additions AGENCY: Committee for Purchase From People Who Are Blind or Severely Disabled. ACTION: Additions to the Procurement List. SUMMARY: This action adds to the Procurement List services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities. DATES: *Effective Date:* July 27, 2008. ADDRESSES: Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259 FOR FURTHER INFORMATION CONTACT: Kimberly M. Zeich, Telephone:
(703)603-7740, Fax:
(703)603-0655, or e-mail *CMTEFedReg@jwod.gov.* SUPPLEMENTARY INFORMATION: On April 25, May 2 and May 9, 2008 the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (73 FR 22324; 24219; 26363) of proposed additions to the Procurement List. After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the services and impact of the additions on the current or most recent contractors, the Committee has determined that the services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4. Regulatory Flexibility Act Certification I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were: 1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the services to the Government. 2. The action will result in authorizing small entities to furnish the services to the Government. 3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the services proposed for addition to the Procurement List. End of Certification Accordingly, the following services are added to the Procurement List: Services *Service Type/Location:* Custodial & Grounds Maintenance, U.S. Federal Building and Courthouse—St. Croix, 3013 Estate Golden Rock, Christiansted, U.S. Virgin Islands. *NPA:* The Corporate Source, Inc., New York, NY. *Contracting Activity:* General Services Administration, Caribbean Property Management Center, Hato Rey, PR. *Service Type/Location:* Mailroom Operations, Internal Revenue Service, 10715 David Taylor Drive, Charlotte, NC. *NPA:* Employment Source, Inc., Fayetteville, NC. *NPA:* ServiceSource, Inc., Alexandria, VA (prime contractor). *Contracting Activity:* U.S. Department of the Treasury, Internal Revenue Service Headquarters, Oxon Hill, MD. *Service Type/Location:* Laundry Refurbishment Services, Billings Fire Cache, 551 Northview Drive, Billings, MT. *NPA:* Community Option Resource Enterprises, Inc., Billings, MT. *Contracting Activity:* U.S. Department of the Interior, Bureau of Land Management—Montana State Office, Billings, MT. This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts. Patrick Rowe, Deputy Executive Director. [FR Doc. E8-14628 Filed 6-26-08; 8:45 am] BILLING CODE 6353-01-P COMMITTEE FOR PURCHASE FROM PEOPLE WHO ARE BLIND OR SEVERELY DISABLED Procurement List; Proposed Additions AGENCY: Committee for Purchase from People Who Are Blind or Severely Disabled. ACTION: Proposed Additions to and Deletions from the Procurement List. SUMMARY: The Committee is proposing to add to the Procurement List services to be performed by nonprofit agencies employing persons who are blind or have other severe disabilities. *Comments Must be Received On or Before:* July 27, 2008. ADDRESSES: Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia, 22202-3259. FOR FURTHER INFORMATION OR TO SUBMIT COMMENTS CONTACT: Kimberly M. Zeich, Telephone:
(703)603-7740, Fax:
(703)603-0655, or e-mail *CMTEFedReg@AbilityOne.gov.* SUPPLEMENTARY INFORMATION: This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions. Additions If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice for each product or service will be required to procure the services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities. Regulatory Flexibility Act Certification I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were: 1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will services to the Government. 2. If approved, the action will result in authorizing small entities to furnish the services to the Government. 3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the services proposed for addition to the Procurement List. Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information. End of Certification The following services are proposed for addition to Procurement List for production by the nonprofit agencies listed: Services Service Type/Location: Custodial Services. Grand Prairie Army Reserve Complex, Buildings 7900; 8070 and 8100, Grand Prairie, TX. *NPA:* Goodwill Industrial Services of Fort Worth, Inc., Fort Worth, TX. *Contracting Activity:* Army Reserve Contracting Center, 90th Regional Support Command, North Little Rock, AR. Service Type/Location: Custodial Services. Illinois Military Academy, 1301 North MacArthur Blvd, Springfield, IL. *NPA:* United Cerebral Palsy of the Land of Lincoln, Springfield, IL. *Contracting Activity:* Illinois National Guard—Camp Lincoln, Springfield, IL. Service Type/Location: Warehousing & Distribution Service. Naval Base Kitsap—Fleet and Industrial Supply Center (FISC), Bremerton, WA. Service Type/Location: Warehousing & Distribution Service. Navy Undersea Warfare Center
(NUWC)Division, Keyport, WA. Service Type/Location: Warehousing & Distribution Service. Puget Sound Naval Shipyard
(PSNS)and Intermediate Maintenance Facility
(IMF)Submarine Base, Bangor, WA. *NPA:* Skookum Educational Programs, Bremerton, WA. *Contracting Activity:* Fleet and Industrial Supply Center, Bremerton, WA. Service Type/Location: Custodial Services. US Coast Guard, Industrial Support Detachment
(ISD)Building, 110 Mount Elliott Street, Detroit, MI. *NPA:* New Horizons Rehabilitation Services, Inc., Auburn Hills, MI. *Contracting Activity:* Department of Homeland Security, U.S. Coast Guard—Integrated Support Command (ISC), Cleveland, OH. Service Type/Location: Medical Transcription. VA Southern Nevada Healthcare System, 2455 West Cheyenne Avenue, Las Vegas, NV. *NPA:* National Telecommuting Institute, Inc., Boston, MA. *Contracting Activity:* Department of Veterans Affairs, VISN 22 Network Business Center, Long Beach, CA. Service Type/Location: Janitorial Services at Army/Navy Recruiting Office. Recruiting Station Army/Navy, 98-151 Pali Momi Street, Aiea, HI. Service Type/Location: Janitorial Services at Air Force/Marine Corps Recruit. Recruiting Station 2, Air Force/Marine Corps, 98-151 Pali Momi Street, Aiea, HI. Service Type/Location: Janitorial Services at Air Force Reserve Center. Recruiting Station 3 Air Force Reserve Center, 98-145 Kaonohi Street, Aiea, HI. Service Type/Location: Janitorial Service at Army/Navy/Marines/AF Recruiting. Recruiting Station 4 Army/Navy/Marines/AF, 45-480 Kaneohe Bay Drive, Kaneohe, HI. Service Type/Location: Janitorial Services at Army Recruiting Office. Recruiting Station 5 Army, 95-1249 Meheula Parkway, Mililani, HI. *NPA:* Goodwill Contract Services of Hawaii, Inc., Honolulu, HI. *Contracting Activity:* U.S. Army Engineering Division, Contracting Division, Honolulu, HI. Patrick Rowe, Deputy Executive Director. [FR Doc. E8-14627 Filed 6-26-08; 8:45 am] BILLING CODE 6353-01-P DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request The Department of Commerce will submit to the Office of Management and Budget
(OMB)for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). *Agency:* International Trade Administration (ITA). *Title:* Steel Import License. *Form Number:* ITA-4141P. *OMB Control Number:* 0625-0245. *Type of Request:* Regular submission. *Burden Hours:* 100,000. *Number of Respondents:* 3,500. *Average Hours per Response:* 10 minutes. *Needs and Uses:* In order to effectively monitor steel imports, the Department of Commerce must collect and provide timely aggregated summaries about these imports. The Steel Import License, proposed by the ITA/Import Administration, is the tool used to collect the necessary information. The Census Bureau currently collects steel import data and disseminates aggregate information, however, this process can take up to 90 days after importation of the product, giving interested parties and the public far less time to respond to injurious sales. The license process provides real-time information to the public which allows more time to address injurious sales. *Affected Public:* Business and other for-profit organizations. *Frequency:* On occasion. *Respondent's Obligation:* Required to obtain or retain a benefit. *OMB Desk Officer:* David Rostker,
(202)395-3897. Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer,
(202)482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at *dHynek@doc.gov* ). Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to David Rostker, OMB Desk Officer, Fax number
(202)395-7285 or via the Internet at *David_Rostker@omb.eop.gov* . Dated: June 24, 2008. Gwellnar Banks, Management Analyst, Office of the Chief Information Officer. [FR Doc. E8-14593 Filed 6-26-08; 8:45 am] BILLING CODE 3510-DS-P DEPARTMENT OF COMMERCE National Institute of Standards and Technology Notice of Invention Available for Licensing AGENCY: National Institute of Standards and Technology, Commerce. ACTION: Notice of Invention Available for Licensing. SUMMARY: The invention listed below is owned in whole by the U.S. Government, as represented by the Secretary of Commerce. The U.S. Government's interest in this invention is available for licensing in accordance with 35 U.S.C. 207 and 37 CFR 404 to achieve expeditious commercialization of results of federally funded research and development. FOR FURTHER INFORMATION CONTACT: Technical and licensing information on this invention may be obtained by writing to: National Institute of Standards and Technology, Office of Technology Partnerships, Attn: Mary Clague, Building 222, Room A240, Gaithersburg, MD 20899. Information is also available via telephone: 301-975-4188, fax 301-975-3482, or e-mail: *mary.clague@nist.gov.* Any request for information should include the NIST Docket number and title for the invention as indicated below. SUPPLEMENTARY INFORMATION: NIST may enter into a Cooperative Research and Development Agreement (“CRADA”) with the licensee to perform further research on the invention for purposes of commercialization. The invention available for licensing is: [NIST Docket Number: 06-011] *Title:* Gradient Elution Moving Boundary Electrophoresis (GEMBE). *Abstract:* GEMBE is a method for performing electrophoretic separation and/or purification of compounds in a mixture. The essence of the invention is the use of a variable bulk flow in electrophoresis. The method uses the electrophoretic migration of chemical species in solution in combination with variable hydrodynamic bulk flow of the solution through a separation capillary or microfluidic channel. GEMBE can be used with the bulk flow solution flow in either direction with respect to the electrophoretic driving force. Continuous sample introduction eliminates the need for a sample injection mechanism, allowing for significant miniaturization. Dated: June 18, 2008. Richard F. Kayser, Chief Scientist. [FR Doc. E8-14635 Filed 6-26-08; 8:45 am] BILLING CODE 3510-10-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Marine Debris Survey in the Coastal North Carolina Region AGENCY: National Oceanic and Atmospheric Administration (NOAA). ACTION: Notice. SUMMARY: The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. DATES: Written comments must be submitted on or before August 26, 2008. ADDRESSES: Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at *dHynek@doc.gov* ). FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection instrument and instructions should be directed to Shay Viehman, 252-728-8744 or *shay.viehman@noaa.gov* . SUPPLEMENTARY INFORMATION: I. Abstract NOAA National Ocean Service's
(NOS)Center for Coastal Fisheries and Habitat Research (CCFHR) has received funding from the NOAA Marine Debris Program to assess perceptions of marine debris (including derelict fishing gear) occurrence and distribution, environmental impacts, potential causes, and suggestions for reduction. The statutory authorities supporting this research are the Marine Debris Research, Prevention, and Reduction Act of 2006 (33 U.S.C. 1951 *et seq.* ), and the Coastal Zone Management Act of 1972 (16 U.S.C. 1455). NOS CCFHR requests information from fishermen holding either a commercial fishing license or a license for recreational fishermen to use commercial fishing gear issued by the State of North Carolina who fish in Core and Back Sounds. Upon receipt, this information will help determine the status of marine debris within Core and Back Sounds, North Carolina. II. Method of Collection Person-to-person survey technique. III. Data *OMB Control Number:* None. *Form Number:* None. *Type of Review:* Regular submission. *Affected Public:* Business or other for-profit organizations; individuals or households. *Estimated Number of Respondents:* 200. *Estimated Time per Response:* 25 minutes. *Estimated Total Annual Burden Hours:* 83. *Estimated Total Annual Cost to Public:* $0. IV. Request for Comments Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record. Dated: June 24, 2008. Gwellnar Banks, Management Analyst, Office of the Chief Information Officer. [FR Doc. E8-14592 Filed 6-26-08; 8:45 am] BILLING CODE 3510-JE-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XI65 Endangered and Threatened Species; Take of Anadromous Fish AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Receipt of application for research permit
(1414)and request for comment. SUMMARY: Notice is hereby given that NMFS has received an application for scientific research from East Bay Municipal Utility District (EBMUD) in Lodi, CA. The permit would affect the federally threatened Central Valley steelhead Distinct Population Segment (DPS), as identified in the SUPPLEMENTARY INFORMATION section. This document serves to notify the public of the availability of the permit application for review and comment. DATES: Written comments on the permit application must be received no later than 5 p.m. Pacific Standard Time on July 18, 2008. ADDRESSES: Written comments on the permit application should be sent to the appropriate office. Comments may also be sent via fax to the number indicated for the request. Comments will not be accepted if submitted via e-mail or the Internet. The applications and related documents are available for review by appointment, for permit 1414: Protected Resources Division, NMFS, 650 Capitol Mall, Suite 8-300, Sacramento, CA 95814 (ph: 916-930-3600, fax: 916-930-3629). Documents may also be reviewed by appointment in the Office of Protected Resources, F/PR3, NMFS, 1315 East-West Highway, Silver Spring, MD 20910-3226 (301-713-1401). FOR FURTHER INFORMATION CONTACT: Shirley Witalis at phone number 916-930-3606, or e-mail: *Shirley.Witalis@noaa.gov* . SUPPLEMENTARY INFORMATION: Authority Issuance of permits and permit modifications, as required by the Endangered Species Act of 1973 (16 U.S.C. 1531-1543) (ESA), is based on a finding that such permits/modifications:
(1)are applied for in good faith;
(2)would not operate to the disadvantage of the listed species which are the subject of the permits; and
(3)are consistent with the purposes and policies set forth in section 2 of the ESA. Authority to take listed species is subject to conditions set forth in the permits. Permits and modifications are issued in accordance with and are subject to the ESA and NMFS regulations governing listed fish and wildlife permits (50 CFR parts 222-226). Those individuals requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see ADDRESSES ). The holding of such a hearing is at the discretion of the Assistant Administrator for Fisheries, NOAA. All statements and opinions contained in the permit action summaries are those of the applicant and do not necessarily reflect the views of NMFS. Species Covered in This Notice This notice is relevant to federally threatened Central Valley steelhead ( *Oncorhynchus mykiss* ). Application Received EBMUD requests a five-year permit
(1414)to conduct monitoring and research of anadromous (Central Valley steelhead) and resident fishes in the Lower Mokelumne River. The goals of the project include measuring the success of the Lower Mokelumne River Restoration Program and determining if the modifications of the Lower Mokelumne River Project are appropriate for conserving fish and wildlife resources in the Lower Mokelumne River. Data will also be collected for developing a Hatchery and Genetics Management Plan for the Mokelumne River Fish Hatchery steelhead artificial propagation program. EBMUD's monitoring and research will consists of trapping, sampling, measuring, weighing and tagging fish, fish carcass surveying, and collecting *O. mykiss* tissue samples. Dated: June 23, 2008. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service. [FR Doc. E8-14648 Filed 6-26-08; 8:45 am] BILLING CODE 3510-22-S COMMITTEE FOR THE IMPLEMENTATION OF TEXTILE AGREEMENTS Amendment to the 2008 Tariff Preference Level
(TPL)for Nicaragua under the Central America-Dominican Republic-United States Free Trade Agreement (CAFTA-DR) June 23, 2008. AGENCY: Committee for the Implementation of Textile Agreements (CITA). ACTION: Amending the 2008 TPL for Nicaragua. EFFECTIVE DATE: **June 27, 2008.** SUMMARY: This notice reduces the 2008 TPL for Nicaragua to 87,897,046 square meters equivalent to account for the shortfall in meeting the one-to-one commitment for cotton and man-made fiber woven trousers exported from Nicaragua to the United States. FOR FURTHER INFORMATION CONTACT: Richard Stetson, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce,
(202)482-3400. SUPPLEMENTARY INFORMATION: Authority: Annex 3.28 of the CAFTA-DR; Section 1634(a)(2) and (c)(2) of the Pension Protection Act of 2006 (P.L. 109-280); Presidential Proclamation 8111 of February 28, 2007. BACKGROUND: Annex 3.28 of the CAFTA-DR establishes a TPL for non-originating apparel goods of Nicaragua. Section 1634(a)(2) of the Pension Protection Act references the exchange of letters between the United States and Nicaragua, which establishes the one-to-one commitment for cotton and man-made fiber trousers. Section 1634(c)(2) of the Pension Protection Act authorizes the President to proclaim a reduction in the overall limit in the TPL if the President determines that Nicaragua has failed to comply with the one-to-one commitment. In Presidential Proclamation 8111, the President delegated to CITA the authority to determine whether Nicaragua had failed to comply with the one-to-one commitment and to reduce the overall limit in the TPL. In an exchange of letters dated March 24 and 27, 2006, Nicaragua agreed that for each square meter equivalent of exports of cotton and man-made fiber woven trousers entered under the TPL, Nicaragua would export to the United States an equal amount of cotton and man-made fiber woven trousers made of U.S. formed fabric of U.S. formed yarn. This commitment for cotton woven trousers applies to the first 30 million square meters equivalent in 2007, the second year after the date of entry into force of the CAFTA-DR. Further, any shortfall in meeting this commitment that was not rectified by April 1 of the succeeding year would be applied against the TPL for the succeeding year. For 2007, the shortfall in meeting the one-to-one commitment is 12,102,954 square meters equivalent. This amount is being deducted from the 2008 TPL, resulting in a new TPL level for 2008 of 87,897,046 square meters equivalent. R. Matthew Priest, Chairman, Committee for the Implementation of Textile Agreements. [FR Doc. E8-14638 Filed 6-26-08; 8:45 am] BILLING CODE 3510-DS-S CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Information Collection; Submission for OMB Review, Comment Request AGENCY: Corporation for National and Community Service. ACTION: Notice. SUMMARY: The Corporation for National and Community Service (hereinafter the “Corporation”), has submitted a public information collection request
(ICR)entitled the AmeriCorps*VISTA Project Progress Report (OMB Control Number 3045-0043) to the Office of Management and Budget
(OMB)for review and approval in accordance with the Paperwork Reduction Act of 1995, Pub. L. 104-13, (44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Mr. Craig Kinnear at
(202)606-9708. Individuals who use a telecommunications device for the deaf (TTY-TDD) may call
(202)565-2799 between 8:30 a.m. and 5 p.m. eastern time, Monday through Friday. ADDRESSES: Comments may be submitted, identified by the title of the information collection activity, to the Office of Information and Regulatory Affairs, Attn: Ms. Katherine Astrich, OMB Desk Officer for the Corporation for National and Community Service, by any of the following two methods within 30 days from the date of publication in this **Federal Register** :
(1)By fax to:
(202)395-6974, Attention: Ms. Katherine Astrich, OMB Desk Officer for the Corporation for National and Community Service; and
(2)Electronically by e-mail to: *Katherine_T._Astrich@omb.eop.gov* . SUPPLEMENTARY INFORMATION: The OMB is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Propose ways to enhance the quality, utility, and clarity of the information to be collected; and • Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. Comments A 60-day public comment Notice was published in the **Federal Register** on March 4, 2008. This comment period ended May 4, 2008. No public comments were received from this notice. Description The Progress Report
(PPR)was designed to assure that AmeriCorps*VISTA sponsors address and fulfill legislated program purposes, meet agency program management and grant requirements, and assess progress toward project plan goals agreed upon in the signing of the Memorandum of Agreement. The Corporation seeks to revise the previously used Project Application to:
(a)Better align the information requested on the Concept Paper and the Application; and
(b)simplify the project plan while continuing to provide a robust tool for evaluating project performance. The Corporation seeks to revise the previously used PPR to:
(a)Reduce respondent burden;
(b)enhance data elements collected via this information collection tool;
(c)establish reporting periods consistent with the Corporation's integrated grants management and reporting policies. The current PPR is used by AmeriCorps*VISTA sponsors and grantees to report progress toward accomplishing work plan goals and objectives, reporting actual outcomes related to self-nominated performance measures meeting challenges encountered, describing significant activities, and requesting technical assistance. The PPR is also used to collect demographic data elements used by the Corporation for aggregate reporting purposes. Submissions of the PPR are done quarterly. The revised PPR will be divided into two separate parts in order to reduce burden and to increase data integrity. All demographic data elements will be removed from the quarterly submissions and added to an annual VISTA Progress Report Supplement
(VPRS)due 30 days after the end of a fiscal year. The quarterly reports will retain their purpose of providing monitoring and oversight of individual projects, while the annual data collection will serve the purpose of aggregate performance reporting for the VISTA program. Burden will be reduced by collecting the demographic data elements once a year instead of quarterly. Data integrity will be increased by tying data elements to specific fiscal years rather than project reporting cycles. *Type of Review:* Renewal. *Agency:* Corporation for National and Community Service. *Title:* AmeriCorps*VISTA Project Progress Report (PPR). *OMB Number:* 3045-0043. *Agency Number:* None. *Affected Public:* AmeriCorps*VISTA sponsoring organizations. *PPR (Part A):* *Total Respondents:* 1000. *Frequency:* Quarterly. *Average Time per Response:* 7 hours. *Estimated Total Burden Hours:* 28,000 hours. *Total Burden Cost (capital/startup):* None. *Total Burden Cost (operating/maintenance):* None. *VPRS (Part B):* *Total Respondents:* 1000. *Frequency:* Annual. *Average Time Per Response:* 8 hours. *Estimated Total Burden Hours:* 8000 hours. *Total Burden Cost (capital/startup):* None. *Total Burden Cost (operating/maintenance):* None. Dated: June 23, 2008. Jean Whaley, Director, AmeriCorps*VISTA. [FR Doc. E8-14629 Filed 6-26-08; 8:45 am] BILLING CODE 6050-$$-P DEPARTMENT OF DEFENSE Department of the Navy Notice of Public Hearings for the Jacksonville Range Complex Draft Environmental Impact Statement/ Overseas Environmental Impact Statement AGENCY: Department of the Navy, DoD. ACTION: Notice. SUMMARY: Pursuant to section 102(2)(c) of the National Environmental Policy Act
(NEPA)of 1969 (42 United States Code [U.S.C.] § 4321); the Council of Environmental Quality
(CEQ)Regulations for implementing the procedural provisions of NEPA (Title 40 Code of Federal Regulations [CFR] Parts 1500-1508); Department of the Navy Procedures for Implementing NEPA (32 CFR 775); Executive Order
(EO)12114, Environmental Effects Abroad of Major Federal Actions; and Department of Defense
(DoD)regulations implementing EO 12114 (32 CFR Part 187), the Department of the Navy
(Navy)has prepared and filed with the U.S. Environmental Protection Agency a Draft Environmental Impact Statement/Overseas Environmental Impact Statement (EIS/OEIS) on June 18, 2008. The National Marine Fisheries Service
(NMFS)is a Cooperating Agency for the EIS/OEIS. The EIS/OEIS evaluates the potential environmental impacts over a 10-year planning horizon associated with Navy Atlantic Fleet training; research, development, testing, and evaluation (RDT&E) activities; and associated range capabilities enhancements (including infrastructure improvements) within the existing Jacksonville
(JAX)Range Complex Operating Area (OPAREA). The JAX Range Complex geographically encompasses offshore, near-shore, and onshore OPAREA, ranges, and special use airspace (SUA). Components of the JAX Range Complex encompass 50,090 square nautical miles (nm 2 ) of sea space and 62,596 nm 2 of SUA off the coasts of North Carolina, South Carolina, Georgia, and Florida, as well as 20 miles 2 of inland range area in north-central Florida. A Notice of Intent for this Draft EIS/OEIS was published in the **Federal Register** on January 26, 2007 (72 FR 3806). The Navy will conduct four public hearings to receive oral and written comments on the Draft EIS/OEIS. Federal agencies, state agencies, and local agencies and interested individuals are invited to be present or represented at the public hearings. This notice announces the dates and locations of the public hearings for this Draft EIS/OEIS. An open house session will precede the scheduled public hearing at each of the locations listed below and will allow individuals to review the information presented in the JAX Range Complex Draft EIS/OEIS. Navy representatives will be available during the open house sessions to clarify information related to the Draft EIS/OEIS. DATES AND ADDRESSES: All meetings will start with an open house session from 5 p.m. to 7 p.m. A formal presentation and public comment period will be held from 7 p.m. to 9 p.m. Public hearings will be held on the following dates and at the following locations: July 28, 2008 at the Doubletree Guest Suites—Historic Charleston, 181 Church Street, Charleston, SC; July 29, 2008 at the Holiday Inn Beaufort; 2225 Boundry St., Beaufort, SC; July 30, 2008 at the Hyatt Regency Savannah, 2 W. Bay Street, Savannah, GA; July 31, 2008 at the Hyatt Regency Jacksonville—Riverfront; 225 E. Coastline Dr., Jacksonville, FL. FOR FURTHER INFORMATION CONTACT: Naval Facilities Engineering Command, Atlantic, Attention, EV22CM (JAX EIS/OEIS PM), 6506 Hampton Boulevard, Norfolk, Virginia 23508-1278; facsimile: 757-322-4894 or *http://www.jacksonvillerangecomplexeis.com.* SUPPLEMENTARY INFORMATION: The Navy has identified the need to support and conduct current and emerging training and RDT&E operations in the JAX Range Complex. The proposed action does not indicate major changes to JAX Range Complex facilities, operations, training, or RDT&E capacities over the 10-year planning period. Rather, the proposed action would result in relatively small-scale but critical enhancements to the JAX Range Complex that are necessary if the Navy is to maintain a state of military readiness commensurate with its national defense mission. The EIS/OEIS addresses the training strategies described in the Fleet Readiness Training Plan
(FRTP)that implement the Fleet Response Plan, which ensures continuous availability of agile, flexible, trained, and ready surge-capable (rapid response) forces. The recommended range enhancements that have the potential to impact the environment, as well as current and future training and testing operations that have the potential to impact the environment, are the primary focus of the EIS/OEIS. The purpose for the proposed action is to: • Achieve and maintain Fleet readiness using the JAX Range Complex to support and conduct current, emerging, and future training operations and RDT&E operations; • Expand warfare missions supported by the JAX Range Complex; and • Upgrade and modernize existing range capabilities to enhance and sustain Navy training and RDT&E. The need for the proposed action is to provide range capabilities for training and equipping combat-capable naval forces ready to deploy worldwide. In this regard, the JAX Range Complex furthers the Navy's execution of its Congressionally mandated roles and responsibilities under Title 10 U.S.C. § 5062. To implement this Congressional mandate, the Navy needs to: • Maintain current levels of military readiness by training in the JAX Range Complex; • Accommodate future increases in operational training tempo in the JAX Range Complex and support the rapid deployment of naval units or strike groups; • Achieve and sustain readiness of ships and squadrons so the Navy can quickly surge significant combat power in the event of a national crisis or contingency operation, and consistent with the FRTP; • Support the acquisition and implementation into the Fleet of advanced military technology. The JAX Range Complex must adequately support the testing and training needed for new platforms (aircraft and weapons systems); and • Maintain the long-term viability of the JAX Range Complex while protecting human health and the environment, and enhancing the quality and communication capability and safety of the range complex. • Support to current, emerging, and future training and RDT&E operations, including implementation of range enhancements, entails the actions evaluated in the EIS/OEIS. These potentially include: • Increase use of contractor-operated small aircraft that simulate enemy aircraft during training (Commercial Air Services Support for Fleet Opposition Forces and Electronic Warfare Threat Training); • Increase anti-piracy and maritime interdiction training (Anti-terrorism Surface Strike Group Training); • Support MH-60R helicopter warfare mission areas, and Multi-Mission Maritime Aircraft training operations; and • Conduct mine warfare training using a temporary mine training area. The proposed action is to support and conduct current and emerging training and RDT&E operations in the JAX Range Complex. To achieve this, the Navy proposes to: • Maintain training and RDT&E operations at current levels if the No Action Alternative is selected. If either Alternative 1 or Alternative 2 is selected, then: • Increase or modify training and RDT&E operations from current levels as necessary in support of the FRTP. • Accommodate mission requirements associated with force structure changes, including those resulting from the introduction of new platforms (aircraft, and weapons systems). • Implement enhanced range complex capabilities. The decision to be made by the Assistant Secretary of the Navy (Installations & Environment) is to determine which alternative analyzed in the EIS/OEIS satisfies both the level and mix of training to be conducted and the range capabilities enhancements to be made within the JAX Range Complex that best meet the needs of the Navy given that all reasonably foreseeable environmental impacts have been considered. Three alternatives were evaluated in the EIS/OEIS to ensure they met the purpose and need, giving due consideration to range complex attributes such as: The capability to support current and emerging Fleet tactical training and RDT&E requirements; the capability to support realistic, essential training at the level and frequency sufficient to support the FRTP; and the capability to support training requirements while following Navy Personnel Tempo of Operations guidelines. These alternatives include: 1. The No Action Alternative—Current Operations to include surge consistent with the FRTP; 2. Alternative 1—No Action Alternative plus: increase Operational Training, Expand Warfare Missions, Accommodate Force Structure Changes (includes changing weapon systems and platforms and homebasing new aircraft and ships), and implement enhancements, to the minimal extent possible to meet the components of the proposed action. This alternative is composed of all operations currently conducted (No Action Alternative) with modifications to current training or introduction of new training. These would include:
(a)Using more commercial aircraft to serve as oppositional forces rather than using Navy aircraft for Air-to-Air Missile Exercise, Surface-to-Air Gunnery Exercises, Air Intercept Control Exercises, and Detect-to-Engage Exercises;
(b)the incorporation of anti-terrorism training into existing training events;
(c)adjusting training levels to ensure that deployment can be stepped up quickly and at multiple locations in response to world events; and
(d)conducting new or modified training associated with the introduction of the new MH-60 helicopter, and new organic mine countermeasure systems; and 3. Alternative 2 (Preferred Alternative)—Alternative 1 plus: additional mine warfare training capabilities, and implementation of additional enhancements to enable the range complex to meet future requirements. Three alternatives were considered but eliminated from further consideration. These alternatives are: 1. Alternative Range Complex Locations—No single range complex on the East Coast can accommodate the entire spectrum of Navy and Marine Corps training and testing. To maintain a high level of combat readiness for naval forces at best value to the U.S. taxpayer, the Navy and Marine Corps homeported their forces in multiple concentration areas rather than a single area, in part to ensure the surrounding training and testing areas could support their specific needs. The result is a system of range complexes, each optimized to support the limited set of warfare areas that predominate in that locale. The JAX Range Complex possesses a number of historical and natural features that make it an indispensable component of the Navy's East Coast system of ranges. The JAX Range Complex is a vital component of the Atlantic Fleet system of range complexes, necessary and critical to ensure that naval forces are prepared and certified ready for overseas deployment and combat operations. Other locations do not provide reasonable alternatives for required training purposes/activities described above, and as a result, alternative training locations were eliminated from further consideration. 2. Conduct Simulated Training Only—Under this alternative, only simulated training would be conducted using computer models and classroom training. While computer simulation and classroom training are currently used by the Navy and effective training tools, they cannot exclusively replace live training because they do not replicate the atmosphere or experience that live training provides. Simulation cannot replicate the environment that is provided during coordinated training and major exercises, where multiple ships, submarines and aircraft, and hundreds or thousands of men and women are participating in training activities in a coordinated fashion to accomplish a common military objective. Because of the need to train as we fight, this alternative would fail to meet the purpose and need of the proposed action in that it would not sufficiently prepare our naval forces for combat. Therefore, this alternative is not evaluated in the EIS/OEIS. 3. Practice Ammunition Use—An alternative that would rely entirely on inert, practice ammunition use within the JAX Range Complex would not achieve the necessary levels of proficiency in firing weapons in a high stress and realistic environment. Inert, practice ammunition is utilized throughout the JAX Range Complex, and provides opportunity to implement a successful, integrated training program while reducing the risk and expense typically associated with live ammunition. As such, practice ammunition is already utilized extensively to enhance combat performance in the Navy's training program. However, while it is an essential component of training, practice ammunition cannot be used exclusively to train safely in an inherently unsafe combat environment. Consequently, this alternative fails to meet the purpose and need of the proposed action. Therefore, this alternative was not carried forward for analysis. Twenty resources and issues were described and analyzed in the EIS/OEIS. These include but are not limited to water resources, air quality, marine communities, marine mammals, sea turtles, fish and essential fish habitat, seabirds and migratory birds, cultural resources, regional economy, and public health and safety. The Navy used subject matter experts, public and agency scoping comments, previous environmental analyses, previous agency consultations, laws, regulations, Executive Orders and resource-specific information in a screening process to identify aspects of the proposed action that could act as stressors to resources and issues evaluated in the EIS/OEIS. The stressors considered for analysis of environmental consequences include but are not limited to vessel movements (disturbance and collisions), aircraft overflights (disturbance and strikes), non-explosive practice munitions, and underwater detonations and high explosive ordnance. In accordance with 50 CFR § 401.12, the Navy submitted a Biological Evaluation to assess the potential effects from the proposed action on marine resources and anadromous fish protected by the NMFS under the Endangered Species Act (ESA). In accordance with the Marine Mammal Protection Act MMPA (16 U.S.C. § 1371[a][5]), the Navy submitted a request for Letter of Authorization to the NMFS for the incidental taking of marine mammals by the proposed action which was acknowledged by NMFS in a Notice of Receipt published in the **Federal Register** (Vol. 73, No. 72, pp. 20032-20034) on April 14, 2008. The Navy submitted a Consultation Package in accordance with legal requirements set forth under regulations implementing section 7 of the ESA (50 CFR 402; 16 U.S.C 1536(c)) for listed species under jurisdiction of the U.S. Fish and Wildlife Service. The analysis of environmental stressors indicated that implementation of the No Action Alternative, Alternative 1, or Alternative 2 would not result in unavoidable significant adverse effects to resources analyzed. The analysis of environmental stressors and alternatives indicated no significant impact to resources in U.S. territorial waters; likewise, no significant harm in non-territorial waters are expected. The JAX Draft EIS/OEIS was distributed to Federal, State, and local agencies, elected officials, and other interested individuals and organizations on June 27, 2008. The public comment period will end on August 11, 2008. Copies of the JAX Draft EIS/OEIS are available for public review at the following libraries: Charleston County Library, 68 Calhoun Street; Charleston, SC; Beaufort County Public Library, 311 Scott Street, Beaufort, SC; Live Oak Public Libraries, 2002 Bull Street, Savannah, GA; Three Rivers Regional Library System, 208 Gloucester Street, Brunswick, GA; Jacksonville Public Library, 303 North Laura Street, Jacksonville, FL; Polk County Library Cooperative, 215 South Bougainvillea Avenue, Polk City, FL; and Marion County Public Library, 2720 East Silver Springs Boulevard, Ocala, FL. The JAX Draft EIS/OEIS is also available for electronic public viewing at *http://www.jacksonvillerangecomplexeis.com.* A paper copy of the Executive Summary or a single CD with the JAX Draft EIS/OEIS will be made available upon written request by contacting Naval Facilities Engineering Command, Atlantic Division; Attention: Code EV22CM (JAX EIS/OEIS PM); 6506 Hampton Blvd.; Norfolk, VA 23508-1278. Facsimile: 757-322-4894. Federal, State, and local agencies and interested parties are invited to be present or represented at the public hearing. Written comments can also be submitted during the open house sessions preceding the public hearings. Oral statements will be heard and transcribed by a stenographer; however, to ensure the accuracy of the record, all statements should be submitted in writing. All statements, both oral and written, will become part of the public record on the Draft EIS/OEIS and will be responded to in the Final EIS/OEIS. Equal weight will be given to both oral and written statements. In the interest of available time, and to ensure all who wish to give an oral statement have the opportunity to do so, each speaker's comments will be limited to three
(3)minutes. If a long statement is to be presented, it should be summarized at the public hearing with the full text submitted either in writing at the hearing, or mailed or faxed to Naval Facilities Engineering Command, Atlantic Division; Attention: Code EV22CM (JAX EIS/OEIS PM); 6506 Hampton Blvd.; Norfolk, VA 23508-1278. Facsimile: 757-322-4894. In addition, comments may be submitted on-line at *http://www.jacksonvillerangecomplexeis.com* during the comment period. All written comments must be postmarked by August 11, 2008 to ensure they become part of the official record. All comments will be addressed in the Final EIS/OEIS. Dated: June 23, 2008. T.M. Cruz, Lieutenant, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer. [FR Doc. E8-14541 Filed 6-26-08; 8:45 am] BILLING CODE 3810-FF-P DEPARTMENT OF DEFENSE Department of the Navy Notice of Public Hearings for the Virginia Capes Range Complex Draft Environmental Impact Statement/Overseas Environmental Impact Statement AGENCY: Department of the Navy, DoD. ACTION: Notice. SUMMARY: Pursuant to section 102(2)(c) of the National Environmental Policy Act
(NEPA)of 1969 (42 United States Code [U.S.C.] 4321); the Council of Environmental Quality
(CEQ)Regulations for implementing the procedural provisions of NEPA (Title 40 Code of Federal Regulations [CFR] 1500-1508); Department of the Navy Procedures for Implementing NEPA (32 CFR 775); Executive Order
(EO)12114, Environmental Effects Abroad of Major Federal Actions; and Department of Defense
(DoD)regulations implementing EO 12114 (32 CFR 187) the Department of the Navy
(Navy)has prepared and filed with the U.S. Environmental Protection Agency a Draft Environmental Impact Statement/Overseas Environmental Impact Statement (EIS/OEIS) on June 16, 2008. The National Marine Fisheries Service
(NMFS)is a Cooperating Agency for the EIS/OEIS. The EIS/OEIS evaluates the potential environmental impacts over a 10-year planning horizon associated with Navy Atlantic Fleet training; research, development, testing, and evaluation (RDT&E) activities; and associated range capabilities enhancements (including infrastructure improvements) within the existing Virginia Capes (VACAPES) Range Complex Operating Area (OPAREA). The components of the VACAPES Range Complex include 28,672 square nautical miles (nm 2 ) of special use area
(SUA)warning area; 27,661 nm 2 of offshore surface and subsurface OPAREA; and 18,092 nm 2 of deep ocean area greater than 100 fathoms (600 feet). The geographic scope of the EIS/OEIS includes the airspace, seaspace, and undersea space of the VACAPES Range Complex. This area is referred to as the VACAPES Study Area. The VACAPES Study Area does not include any dry land. However, it does include the area from the mean high tide line east (seaward) to the 3nm boundary of the states of Delaware, Maryland, Virginia, and North Carolina. This 3-nm state boundary also serves as the western boundary of the VACAPES OPAREA. The VACAPES Study Area also includes 420 nm 2 of the lower Chesapeake Bay. A Notice of Intent
(NOI)for the EIS/OEIS was published in the **Federal Register** on December 8, 2006 ( **Federal Register** Volume 71, No. 236, pp 71143-71145). A revised NOI was issued in the **Federal Register** (Volume 72, No. 171, pp 50940-50941) on September 5, 2007 when training areas in the southern Chesapeake Bay were identified for analysis. The Navy will conduct four public hearings to receive oral and written comments on the Draft EIS/OEIS. Federal agencies, state agencies, and local agencies and interested individuals are invited to be present or represented at the public hearings. This notice announces the dates and locations of the public hearings for this Draft EIS/OEIS. An open house session will precede the scheduled public hearing at each of the locations listed below and will allow individuals to review the information presented in the VACAPES Range Complex Draft EIS/OEIS. Navy representatives will be available during the open house sessions to clarify information related to the Draft EIS/OEIS. Dates and Addresses: All meetings will start with an open house session from 5 p.m. to 7 p.m. A formal presentation and public comment period will be held from 7 p.m. to 9 p.m. Public hearings will be held on the following dates and at the following locations: July 14, 2008 at the Princess Royale Oceanfront Hotel, 9100 Coastal Hwy., Ocean City, MD; July 15, 2008 at the Chincoteague Center, 6155 Community Dr., Chincoteague, VA; July 16, 2008 at the Virginia Beach Resort & Conference Ctr., 2800 Shore Dr., Virginia Beach, VA; and July 17, 2008 at the Hilton Garden Inn, 5353 N. Va. Dare Trail, Kitty Hawk, NC. FOR FURTHER INFORMATION CONTACT: Naval Facilities Engineering Command, Atlantic, Attention, EV22ES (VACAPES EIS/OEIS PM), 6506 Hampton Boulevard, Norfolk, Virginia 23508-1278; facsimile: 757-322-4894 or *http://www.vacapesrangecomplexeis.com.* SUPPLEMENTARY INFORMATION: The Navy has identified the need to support and conduct current and emerging training and RDT&E operations in the VACAPES Range Complex. The proposed action does not indicate major changes to VACAPES Range Complex facilities, operations, training, or RDT&E capacities over the 10-year planning period. Rather, the proposed action would result in relatively small-scale but critical enhancements to the VACAPES Range Complex that are necessary if the Navy is to maintain a state of military readiness commensurate with its national defense mission. The EIS/OEIS addresses the training strategies described in the Fleet Readiness Training Plan
(FRTP)that implement the Fleet Response Plan, which ensures continuous availability of agile, flexible, trained, and ready surge-capable (rapid response) forces. The recommended range enhancements that have the potential to impact the environment, as well as current and future training and testing operations that have the potential to impact the environment, are the primary focus of the EIS/OEIS. The purpose for the proposed action is to: • Achieve and maintain Fleet readiness using the VACAPES Range Complex to support and conduct current, emerging, and future training operations and RDT&E operations; • Expand warfare missions supported by the VACAPES Range Complex; and • Upgrade and modernize existing range capabilities to enhance and sustain Navy training and RDT&E. The need for the proposed action is to provide range capabilities for training and equipping combat-capable naval forces ready to deploy worldwide. In this regard, the VACAPES Range Complex furthers the Navy's execution of its congressionally mandated roles and responsibilities under Title 10 U.S.C. 5062. To implement this Congressional mandate, the Navy needs to: • Maintain current levels of military readiness by training in the VACAPES Range Complex; • Accommodate future increases in operational training tempo in the VACAPES Range Complex and support the rapid deployment of naval units or strike groups; • Achieve and sustain readiness of ships and squadrons so the Navy can quickly surge significant combat power in the event of a national crisis or contingency operation, and consistent with the FRTP; • Support the acquisition and implementation into the Fleet of advanced military technology. The VACAPES Range Complex must adequately support the testing and training needed for new platforms (aircraft and weapons systems); and • Maintain the long-term viability of the VACAPES Range Complex while protecting human health and the environment, and enhancing the quality and communication capability and safety of the range complex. Support to current, emerging, and future training and RDT&E operations, including implementation of range enhancements, entails the actions evaluated in the EIS/OEIS. These potentially include: • Increase use of contractor-operated small aircraft that simulate enemy aircraft during training (Commercial Air Services Support for Fleet Opposition Forces and Electronic Warfare Threat Training); • Increase anti-piracy and maritime interdiction training (Anti-terrorism Surface Strike Group Training); • Support MH-60R/S helicopter warfare mission areas, and Multi-Mission Maritime Aircraft training operations; and • Conduct mine warfare training using a temporary mine training area. The proposed action is to support and conduct current and emerging training and RDT&E operations in the VACAPES Range Complex. To achieve this, the Navy proposes to: • Maintain training and RDT&E operations at current levels if the No Action Alternative is selected. If either Alternative 1 or Alternative 2 is selected, then: • Increase or modify training and RDT&E operations from current levels as necessary in support of the FRTP. • Accommodate mission requirements associated with force structure changes, including those resulting from the introduction of new platforms (aircraft, and weapons systems). • Implement enhanced range complex capabilities. The decision to be made by the Assistant Secretary of the Navy (Installations & Environment) is to determine which alternative analyzed in the EIS/OEIS satisfies both the level and mix of training to be conducted and the range capabilities enhancements to be made within the VACAPES Range Complex that best meet the needs of the Navy given that all reasonably foreseeable environmental impacts have been considered. Three alternatives were evaluated in the EIS/OEIS to ensure they met the purpose and need, giving due consideration to range complex attributes such as: the capability to support current and emerging Fleet tactical training and RDT&E requirements; the capability to support realistic, essential training at the level and frequency sufficient to support the FRTP; and the capability to support training requirements while following Navy Personnel Tempo of Operations guidelines. These alternatives include: 1. The No Action Alternative—Current Operations to include surge consistent with the FRTP; 2. Alternative 1—No Action Alternative plus: increase Operational Training, Expand Warfare Missions, Accommodate Force Structure Changes (includes changing weapon systems and platforms and homebasing new aircraft and ships), and implement enhancements, to the minimal extent possible to meet the components of the proposed action. This alternative is composed of all operations currently conducted (No Action Alternative) with modifications to current training or introduction of new training. These would include:
(a)Using more commercial aircraft to serve as oppositional forces rather than using Navy aircraft for Air-to-Air Missile Exercise, Surface-to-Air Gunnery Exercises, Air Intercept Control Exercises, and Detect-to-Engage Exercises;
(b)the incorporation of anti-terrorism training into existing training events;
(c)adjusting training levels to ensure that deployment can be stepped up quickly and at multiple locations in response to world events; and
(d)conducting new or modified training associated with the introduction of the new MH-60 helicopter, and new organic mine countermeasure systems; and 3. Alternative 2 (Preferred Alternative)—Alternative 1 plus: enhanced mine warfare training capabilities, a reduction of live bombing exercises, and implementation of additional enhancements to enable the range complex to meet future requirements. Three alternatives were considered but eliminated from further consideration. These include: 1. Alternative Range Complex Locations—No single range complex on the East Coast can accommodate the entire spectrum of Navy and Marine Corps training and testing. To maintain a high level of combat readiness for naval forces at best value to the U.S. taxpayer, the Navy and Marine Corps homeported their forces in multiple concentration areas rather than a single area, in part to ensure the surrounding training and testing areas could support their specific needs. The result is a system of range complexes, each optimized to support the limited set of warfare areas that predominate in that locale. The VACAPES Range Complex possesses a number of historical and natural features that make it an indispensable component of the Navy's East Coast system of ranges. The VACAPES Range Complex is a vital component of the Atlantic Fleet system of range complexes, necessary and critical to ensure that naval forces are prepared and certified ready for overseas deployment and combat operations. Other locations do not provide reasonable alternatives for required training purposes/activities described above, and as a result, alternative training locations were eliminated from further consideration. 2. Conduct Simulated Training Only—Under this alternative, only simulated training would be conducted using computer models and classroom training. While computer simulation and classroom training are currently used by the Navy and effective training tools, they cannot exclusively replace live training because they do not replicate the atmosphere or experience that live training provides. Simulation cannot replicate the environment that is provided during coordinated training and major exercises, where multiple ships, submarines and aircraft, and hundreds or thousands of men and women are participating in training activities in a coordinated fashion to accomplish a common military objective. Because of the need to train as we fight, this alternative would fail to meet the purpose and need of the proposed action in that it would not sufficiently prepare our naval forces for combat. Therefore, this alternative is not evaluated in the EIS/OEIS. 3. Practice Ammunition Use—An alternative that would rely entirely on inert, practice ammunition use within the VACAPES Range Complex would not achieve the necessary levels of proficiency in firing weapons in a high stress and realistic environment. Inert, practice ammunition is utilized throughout the VACAPES Range Complex, and provides opportunity to implement a successful, integrated training program while reducing the risk and expense typically associated with live ammunition. As such, practice ammunition is already utilized extensively to enhance combat performance in the Navy's training program. However, while it is an essential component of training, practice ammunition cannot be used exclusively to train safely in an inherently unsafe combat environment. Consequently, this alternative fails to meet the purpose and need of the proposed action. Therefore, this alternative was not carried forward for analysis. Nineteen resources and issues were described and analyzed in the EIS/OEIS. These include but are not limited to water resources, air quality, marine communities, marine mammals, sea turtles, fish and essential fish habitat, seabirds and migratory birds, cultural resources, regional economy, and public health and safety. The Navy used subject matter experts, public and agency scoping comments, previous environmental analyses, previous agency consultations, laws, regulations, Executive Orders and resource-specific information in a screening process to identify aspects of the proposed action that could act as stressors to resources and issues evaluated in the EIS/OEIS. The stressors considered for analysis of environmental consequences include but are not limited to vessel movements (disturbance and collisions), aircraft overflights (disturbance and strikes), non-explosive practice munitions, and underwater detonations and high explosive ordnance. In accordance with 50 CFR 401.12 the Navy submitted a Biological Evaluation to assess the potential effects from the proposed action on marine resources and anadromous fish protected by the NMFS under the Endangered Species Act (ESA). In accordance with the Marine Mammal Protection Act MMPA (16 U.S.C. 1371[a][5]), the Navy submitted a request for Letter of Authorization to the NMFS for the incidental taking of marine mammals by the proposed action which was acknowledged by NMFS in a Notice of Receipt published in the **Federal Register** (Vol. 73, No. 72, pp 20032-20034) on April 14, 2008. The Navy submitted a Consultation Package in accordance with legal requirements set forth under regulations implementing Section 7 of the ESA (50 CFR 402; 16 U.S.C 1536 (c)) for listed species under jurisdiction of the U.S. Fish and Wildlife Service. The analysis of environmental stressors indicated that implementation of the No Action Alternative, Alternative 1, or Alternative 2 would not result in unavoidable significant adverse effects to resources and issues analyzed. The analysis of environmental stressors and alternatives indicated no significant impact to resources and issues in U.S. territorial waters; likewise, no significant harm in non-territorial waters would be expected. The VACAPES Draft EIS/OEIS was distributed to Federal, State, and local agencies, elected officials, and other interested individuals and organizations on June 27, 2008. The public comment period will end on August 11, 2008. Copies of the VACAPES Draft EIS/OEIS are available for public review at the following libraries: Ocean City Branch Library, 10003 Coastal Highway, Ocean City, MD; Rehoboth Beach Public Library, 226 Rehoboth Avenue Rehoboth Beach, DE; Wicomico Public Library, 122 South Division Street, Salisbury, MD; Island Library, 4077 Main Street, Chincoteague, VA; Central Library, 4100 Virginia Beach Blvd, Virginia Beach, VA; and Kill Devil Hills Branch Library, 400 S. Mustian St, Kill Devil Hills, NC. The VACAPES Draft EIS/OEIS is also available for electronic public viewing at *http://www.vacapesrangecomplexeis.com.* A paper copy of the Executive Summary or a single CD with the VACAPES Draft EIS/OEIS will be made available upon written request by contacting Naval Facilities Engineering Command, Atlantic Division; Attention: Code EV22ES (VACAPES EIS/OEIS PM); 6506 Hampton Blvd; Norfolk, VA 23508-1278; facsimile: 757-322-4894. Federal, State, and local agencies and interested parties are invited to be present or represented at the public hearing. Written comments can also be submitted during the open house sessions preceding the public hearings. Oral statements will be heard and transcribed by a stenographer; however, to ensure the accuracy of the record, all statements should be submitted in writing. All statements, both oral and written, will become part of the public record on the Draft EIS/OEIS and will be responded to in the Final EIS/OEIS. Equal weight will be given to both oral and written statements. In the interest of available time, and to ensure all who wish to give an oral statement have the opportunity to do so, each speaker's comments will be limited to three
(3)minutes. If a long statement is to be presented, it should be summarized at the public hearing with the full text submitted either in writing at the hearing, or mailed or faxed to Naval Facilities Engineering Command, Atlantic Division; Attention: Code EV22ES (VACAPES EIS/OEIS PM); 6506 Hampton Blvd; Norfolk, VA 23508-1278; facsimile: 757-322-4894. In addition, comments may be submitted on-line at *http://www.vacapesrangecomplexeis.com* during the comment period. All written comments must be postmarked by August 11, 2008 to ensure they become part of the official record. All comments will be addressed in the Final EIS/OEIS. Dated: June 18, 2008. T.M. Cruz, Lieutenant, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer. [FR Doc. E8-14539 Filed 6-26-08; 8:45 am] BILLING CODE 3810-FF-P DEPARTMENT OF ENERGY Bonneville Power Administration Willow Creek Wind Project AGENCY: Bonneville Power Administration (BPA), Department of Energy (DOE). ACTION: Notice of Availability of Record of Decision (ROD). SUMMARY: The Bonneville Power Administration
(BPA)has decided to offer contract terms for the electrical interconnection into the Federal Columbia River Transmission System (FCRTS) of up to 72 megawatts of power to be generated by the proposed Willow Creek Wind Project (Wind Project). Willow Creek Energy, LLC proposes to construct and operate the proposed Wind Project in Gilliam and Morrow counties, Oregon, and has requested interconnection to the FCRTS at a point along BPA's existing Tower Road-Alkali 115-kilovolt transmission line in Gilliam County, Oregon. BPA will construct a tap to allow the Wind Project to interconnect to BPA's transmission line, and will install new equipment at BPA's existing Boardman Substation in Morrow County, Oregon to accommodate this additional power in the FCRTS. This decision to interconnect the Wind Project is consistent with and tiered to BPA's Business Plan Final Environmental Impact Statement (DOE/EIS-0183, June 1995), and Business Plan ROD (August 1995). ADDRESSES: Copies of this tiered ROD and the Business Plan EIS and ROD may be obtained by calling BPA's toll-free document request line, 1-800-622-4520. The RODs and EIS are also available on our Web site, *www.efw.bpa.gov.* FOR FURTHER INFORMATION, CONTACT: Doug Corkran, Bonneville Power Administration—KEC-4, P.O. Box 3621, Portland, Oregon, 97208-3621; toll-free telephone number 1-800-622-4519; fax number 503-230-5699; or e-mail *dfcorkran@bpa.gov.* Issued in Portland, Oregon, on June 4, 2008. Stephen J. Wright, Administrator and Chief Executive Officer. [FR Doc. E8-14610 Filed 6-26-08; 8:45 am] BILLING CODE 6450-01-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8685-8] Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document AGENCY: Environmental Protection Agency (U.S. EPA). ACTION: Notice of Availability. SUMMARY: The U.S. EPA announces the availability of a final document entitled, “Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document” (EPA/600/R-06/013F), which was prepared by the National Center for Environmental Assessment
(NCEA)within the U.S. EPA's Office of Research and Development (ORD). This document represents a collaborative effort between the U.S. EPA and the U.S. Department of Energy (U.S. DOE) that is designed to serve as an interim resource between U.S. EPA's 2003 “Framework for Cumulative Risk Assessment” (EPA/630/P-02/001F) and future documents on approaches and guidance to cumulative risk assessment. The document provides concepts, methods, and data sources for consideration and possible use in the conduct of a cumulative risk assessment. Specifically, the document focuses on two areas:
(1)Initiating factors for a cumulative risk assessment, with procedures for data collection and organization, and
(2)technical approaches for assessing human health risks associated with a subset of cumulative risk issues (i.e., multiple chemicals, exposures, and effects). Overall, this document demonstrates the feasibility of including combinations of chemicals, exposures, effects and their interactions into a cumulative risk assessment and is meant to assist with the conduct of multi-chemical, population-focused assessments. This document has undergone review within the U.S. EPA, independent external peer review by a panel of scientific experts, and it has also benefited from a 45-day public comment period. However, it has not undergone the scrutiny required of a guidance document and, thus, does not represent U.S. EPA policy. DATES: This document will be available on or about June 26, 2008. ADDRESSES: The document will be available electronically through the National Center for Environmental Assessment
(NCEA)Web site at *http://www.epa.gov/ncea.* A limited number of paper copies will be available from the U.S. EPA's National Service Center for Environmental Publications (NSCEP); P.O. Box 42419; Cincinnati, OH 45242;
(800)490-9198 (telephone);
(301)604-3408 (facsimile); *nscep@bps-lmit.com.* Please provide your name, your mailing address, the title and the EPA number of the requested publication. FOR FURTHER INFORMATION CONTACT: Linda K. Teuschler, Project Leader, NCEA-Cin; 26 W. Martin Luther King Dr. (A-G20); Cincinnati, OH 45268;
(513)569-7573 (telephone);
(513)487-2539 (fax); *teuschler.linda@epa.gov* . SUPPLEMENTARY INFORMATION: The U.S. EPA's 2003 “Framework for Cumulative Risk Assessment” and earlier reports from the 1990s on the initial planning and scoping phase needed to conduct a cumulative risk assessment laid a broad foundation for continued development of cumulative risk approaches. The 2003 Framework describes some basic considerations for conducting a cumulative risk assessment and outlines four areas of population vulnerability: Susceptibility or sensitivity, differential exposure (e.g., living in close proximity to pollutant sources), differential preparedness (e.g., lack of disease immunizations), and differential ability to recover from exposures. Since 1986, U.S. EPA technical and guidance documents have been published that address chemical mixture risk assessments which can be used for cumulative risk assessment, but additional research has been needed to address chemical mixtures in combination with multiple exposures and effects. In February 2001, the U.S. EPA began collaborating with the U.S. DOE in an effort to collect data and develop methods for use in cumulative risk assessments. This present document, “Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document,” is the final product of that effort. It further develops the knowledge base for conducting cumulative risk assessments by providing details regarding the evaluation of the human health and population aspects of cumulative risk assessment and by introducing practical ideas for addressing multiple chemicals, exposures, and effects. The U.S. EPA released the external review draft in March 2006 for a 45-day public comment period (see 71 FR 16306-16307, March 31, 2006; Docket ID No. EPA-HQ-ORD-2006-0223). The draft received an independent peer review conducted by the Eastern Research Group under U.S. EPA contract number 68-C-02-060. The peer review included a two-day workshop in May 2006 and featured an external panel of scientific reviewers (see 71 FR 26365-26366, May 4, 2006; Docket ID No. EPA-HQ-ORD-2006-0223). Dated: June 20, 2008. Rebecca Clark, Acting Director, National Center for Environmental Assessment. [FR Doc. E8-14623 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8686-4] Conference Call of the Total Coliform Rule Distribution System Advisory Committee—Notice of Public Conference Call AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: Under Section 10(a)(2) of the Federal Advisory Committee Act, the United States Environmental Protection Agency
(EPA)is giving notice of a conference call of the Total Coliform Rule Distribution System Advisory Committee (TCRDSAC). The purpose of this conference call is to discuss the Total Coliform Rule
(TCR)revisions and information about distribution systems issues that may impact water quality. The TCRDSAC advises and makes recommendations to the Agency on revisions to the TCR, and on what information should be collected, research conducted, and/or risk management strategies evaluated to better inform distribution system contaminant occurrence and associated public health risks. Topics to be discussed during the conference call include options for revising the Total Coliform Rule; for example, rule construct, monitoring provisions, system categories, action levels, investigation and follow-up, public notification, and other related topics. In addition, the Committee will discuss possible recommendations for research and information collection needs concerning distribution systems and topics for upcoming TCRDSAC meetings. DATES: The public conference call will be held on Friday, July 18, 2008 (1 p.m. to 4 p.m., Eastern Time (ET)). To register for the conference call and receive the call in information, attendees should contact Kate Zimmer at
(202)965-6387 or by e-mail to *kzimmer@resolv.org* no later than July 15, 2008. FOR FURTHER INFORMATION CONTACT: For general information, contact Kate Zimmer of RESOLVE at
(202)965-6387. For technical inquiries, contact Sean Conley ( *conley.sean@epa.gov* ,
(202)564-1781), Standards and Risk Management Division, Office of Ground Water and Drinking Water (MC 4607M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; fax number:
(202)564-3767. SUPPLEMENTARY INFORMATION: The conference call is open to the public. The Committee encourages the public's input and will take public comment starting at 2:15 p.m. on July 18, 2008, for this purpose. It is preferred that only one person present the statement on behalf of a group or organization. To ensure adequate time for public involvement, individuals interested in presenting an oral statement may notify Crystal Rodgers-Jenkins, the Designated Federal Officer, by telephone at
(202)564-5275, no later than July 15, 2008. Any person who wishes to file a written statement can do so before or after a Committee meeting or conference call. Written statements received by July 15, 2008, will be distributed to all members before any final discussion or vote is completed. Any statements received on July 16, 2008, or after the conference call, will become part of the permanent meeting and conference call file and will be forwarded to the members for their information. Special Accommodations For information on access or accommodations for individuals with disabilities, please contact Crystal Rodgers-Jenkins at
(202)564-5275 or by e-mail at *rodgers-jenkins.crystal@epa.gov.* Please allow at least 10 days prior to the conference call to give EPA time to process your request. Dated: June 24, 2008. Cynthia Dougherty, Director, Office of Ground Water and Drinking Water. [FR Doc. E8-14620 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0459; FRL-8370-5] Electronic Submission of Certain Pesticide Applications and Data; Availability of Guidance Website AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of Availability. SUMMARY: As of July 15, 2008, the Office of Pesticide Programs
(OPP)will begin accepting certain types of pesticide applications and associated data electronically. The types of applications that will be accepted electronically are Section 3 applications and amendments, Experimental Use Permits, Tolerance Petitions, and Supplemental Distributor Applications. To assist pesticide registrants to properly format their electronic submissions, OPP has established a new web site. This Notice announces the availability of that web site. This site can be accessed at *http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm* . FOR FURTHER INFORMATION CONTACT: John Jamula, Information Technology and Resources Management Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-6426; fax number:
(703)305-7670; e-mail address: *jamula.john@epa.gov* . Or you may contact the E-submission help desk Toll Free: 1-866-612-8664. Voice-mail can be left at any time. E-mail Address: *OPPeSubmissionHelpdesk@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you produce pesticides. Potentially affected entities may include, but are not limited to: Pesticide Registrants. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket* . EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2008-0459. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . II. Background What Action is the Agency Taking? As of July 15, the Office of Pesticide Programs
(OPP)will begin accepting certain types of pesticide applications and associated data electronically. The types of applications that will be accepted electronically are Section 3 applications and amendments, Experimental Use Permits, Tolerance Petitions, and Supplemental Distributor Applications. To assist pesticide registrants to properly format their electronic submissions, OPP has established a new web site. This notice announces the establishment of a new Internet website that contains guidance that will be useful to pesticide companies planning to submit pesticide applications and data electronically. This site can be accessed at *http://www.epa.gov/pesticides/regulating/registering/submissions/index.htm* . List of Subjects Dated: June 16, 2008. Oscar Morales Director, Information Technology and Resources Management Division, Office of Pesticide Programs. [FR Doc. E8-14612 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-8583-2] Environmental Impact Statements and Regulations; Availability of EPA Comments Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167. An explanation of the ratings assigned to draft environmental impact statements
(EISs)was published in FR dated April 11, 2008 (73 FR 19833). Draft EISs *EIS No. 20080134, ERP No. D-NPS-F65070-MI* , Sleeping Bear Dunes National Lakeshore, General Management Plan and Wilderness Study, Implementation, Benzie and Leelanau Counties, MI. *Summary:* EPA does not object to the proposed action. Rating LO. *EIS No. 20080083, ERP No. DS-AFS-D65039-WV* , Lower Williams Project Area (LWPA), Additional Information, Proposed to Perform Vegetation Management and Wildlife Habitat Improvements, Implementation, Gauley Ranger District, Monongahela National Forest, Webster County, WV. *Summary:* EPA expressed environmental concerns about potential adverse impacts to both aquatic and terrestrial habitat. The final EIS should include mitigation measures to minimize impacts to streams and aquatic habitat resources. Rating EC2. Final EISs *EIS No. 20080177, ERP No. F-USN-K11119-HI* , Hawaii Range Complex
(HRC)Project, Preferred Alternative is 3, To Support and Maintain Navy Pacific Fleet Training, and Research, Development, Test, and Evaluation (RDT&E) Operations, Kauai, Honolulu, Maui and Hawaii Counties, HI. *Summary:* EPA expressed environmental concerns about impacts to marine resources from mid-frequency active
(MFA)sonar use and the deposition of hazardous materials into water resources from munitions and training expenditures. *EIS No. 20080182, ERP No. F-AFS-G65106-NM* , Perk-Grindstone Fuel Reduction Project, to Protect Life, Property, and Natural Resources, Village of Ruidoso, Lincoln National Forest, Lincoln County, New Mexico. *Summary:* No formal comment letter was sent to the preparing agency. *EIS No. 20080201, ERP No. F-AFS-J65511-SD* , Upper Spring Creek Project, Proposes to Implementation Multiple Resource Management Actions, Mystic Ranger District, Black Hills National Forest, Pennington and Custer Counties, SD. *Summary:* No formal comment letter was sent to the preparing agency. Dated: June 24, 2008. Ken Mittelholtz, Environmental Protection Specialist, Office of Federal Activities. [FR Doc. E8-14624 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-8583-1] Environmental Impacts Statements; Notice of Availability *Responsible Agency:* Office of Federal Activities, General Information
(202)564-7167 or *http://www.epa.gov/compliance/nepa/.* Weekly receipt of Environmental Impact Statements Filed June 16, 2008 Through June 20, 2008 Pursuant to 40 CFR 1506.9. *EIS No. 20080241, Draft EIS, USN, 00* , Virginia Capes (VACAPES) Range Complex, Proposed action is to Support and Conduct Current and Emerging Training and RDT & E Operations, Chesapeake Bay, DE, MD, VA and NC, *Comment Period* *Ends:* 08/11/2008, *Contact:* Karen Foskey 703-602-2859. *EIS No. 20080242, Draft EIS, BLM, VA,* East Lynn Lake Coal Lease Project, Proposal to Lease Federal Coal that lies under Nine Tracts of Land for Mining, Wayne County, VA, *Comment Period Ends:* 09/24/2008, *Contact:* Chris Carusona 414-297-4463. *EIS No. 20080243, Draft EIS, USN, 00* , Jacksonville Range Complex Project, To Support and Conduct Current and Emerging Training and RDT&E Operations, NC, SC, GA and FL, *Comment Period Ends:* 08/11/2008, *Contact:* Karen Foskey 703-602-2859. *EIS No. 20080244, Final EIS, FAA, FL,* Fort Lauderdale-Hollywood International Airport, Proposed Development and Extension of Runway 9R/27L and other Associated Airport Projects, Funding, U.S. Army COE Section 404 Permit and NPDES Permit, Fort Lauderdale, Broward County, FL, *Wait Period* *Ends:* 07/28/2008, *Contact:* Virginia Lane 407-812-6331. *EIS No. 20080245, Final EIS, FHW, UT* , I-15 Corridor Project, Transportation Improvement from Utah County to Salt Lake County, UT, *Wait Period Ends:* 07/28/2008, *Contact:* Carlos C. Machado 801-963-0182. *EIS No. 20080246, Final Supplement, AFS, UT* , West Bear Vegetation Management Project, Additional Information to Improve a Portion of the Cumulative Effects Analysis and Correct the Soils Analysis, Timber Harvesting, Prescribed Burning, Roads Construction, Township 1 North, Range 9 East, Salt Lake Principle Meridian, Evanston Ranger District, Wasatch-Cache National Forest, Summit County, UT, *Wait Period Ends:* 07/28/2008, *Contact:* Larry Johnson 307-783-3790. *EIS No. 20080247, Final EIS, NCP, DC* , Smithsonian Institution National Museum of African American History and Culture, Construction and Operation, Between 14th and 15th Streets, NW., and Constitution Avenue, NW., and Madison Drive, NW., Washington, DC, *Wait Period Ends:* 07/28/2008, *Contact:* Gene Keller 202-482-7251. *EIS No. 20080248, Final EIS, AFS, ID* , Idaho Cobalt Project, Development of Two Underground Mines, a Waste Disposal Site and Associated Facilities, Approval of Plan-of-Operation, Salmon-Cobalt Ranger District, Salmon-Challis National Forest, Lemhi County, ID, *Wait* *Period Ends:* 07/28/2008, *Contact:* Kimberly Nelson 208-756-5200. *EIS No. 20080249, Final Supplement, BLM, WY* , Pinedale Anticline Oil and Gas Exploration and Development Project, Additional Information on Two New Alternatives, Consolidated Development with Year-Round Development (Construction, Drilling, Completion, and Production), Sublette County, WY, *Wait Period Ends:* 07/28/2008, *Contact:* Caleb Hiner 307-367-5352. *EIS No. 20080250, Draft EIS, FHW, CA* , Orange County Gateway Project, To Provide Grade Separation Alternative along the Burlington Northern Santa Fe Railroad Tracks from west of Bradford Avenue to west of Imperial Highway (State Route 90), Cities of Placentia and Anaheim, Orange County, CA, *Comment Period Ends:* 08/11/2008, *Contact:* Scott McHenry 916-498-5854. *EIS No. 20080251, Draft EIS, AFS, CA* , Moonlight and Wheeler Fires Recovery and Restoration Project, Proposes to Harvest Fire-Killed Merchantable Trees on 15,568 Acres, Mt. Hough Ranger District, Plumas National Forest, Plumas County, CA, *Comment Period Ends:* 08/11/2008, *Contact:* Rich Bednarski 530-283-7641. *EIS No. 20080252, Draft EIS, DHS, 00* , National Bio and Agro-Defense Facility, Proposal to Site, Construct, and Operate at one of the Proposed Locations:
(1)South Milledge Avenue Site, Clarke County, GA;
(2)Manhattan Campus Site, Riley County, KS;
(3)Flora Industrial Park Site, Madison County, MS;
(4)Plum Island Site, Suffolk County, NY;
(5)Umstead Research Park Site, Granville County, NC; and
(6)Texas Research Park Site, Bexar and Medina Counties, TX, *Comment Period Ends:* 08/25/2008, *Contact:* James V. Johnson 202-254-6098. *EIS No. 20080253, Draft EIS, NOA, 00* , Amendment 4 to the Spiny Lobster Fishery Management Plan of Puerto Rico and the U.S. Virgin Islands and Amendment 8 to the Spiny Lobster Fishery Management Plan of the Gulf of Mexico and South Atlantic, To Address the Harvest and Exportation of Undersized Lobster Tails to the United States, *Comment Period* *Ends:* 08/11/2008, *Contact:* Roy E. Crabtree, PhD 727-824-5301. *EIS No. 20080254, Final EIS, NOA, MA* , ADOPTION—Neptune Liquefied Natural Gas (LNG), Construction and Operation, Deepwater Port License Application, (Docket Number USCG-2004-22611) Massachusetts Bay, Gloucester and Boston, MA, *Contact:* James H. Lecky 301-713-2332. US DOC/NOA adopted the US CGD & MARAD Final Supplemental EIS 20060451 filed 10/27/2006. NOA was a cooperating agency on the project. Recirculation of the document is not necessary under 1506.3(b) of the CEQ Regulations. Amended Notices *EIS No. 20080200, Draft EIS, AFS, UT* , Dixie National Forest Motorized Travel Plan, Implementation, Dixie National and the Teasdale portion of the Fremont River Ranger District on the Fishlake National Forest, Garfield, Iron, Kane, Piute, Washington and Wayne Counties, UT, *Comment* *Period Ends:* 07/22/2008, *Contact:* Andi Falsetto 435-896-9233. Revision of FR Notice Published 05/23/2008: Extending Comment Period 07/07/2008 to 07/22/2008. Dated: June 24, 2008. Ken Mittelholtz, Environmental Protection Specialist, Office of Federal Activities. [FR Doc. E8-14626 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2008-0267; FRL-8371-5] Formaldehyde Emissions from Composite Wood Products; Disposition of TSCA Section 21 Petition AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: On March 24, 2008, 25 organizations and approximately 5,000 individuals petitioned EPA under section 21 of the Toxic Substances Control Act
(TSCA)to use section 6 of TSCA to adopt a recently promulgated California State regulation concerning emissions of formaldehyde from three types of composite wood products: Hardwood plywood, particleboard, and medium density fiberboard. They petitioned EPA to assess and reduce the risks posed by formaldehyde emitted from these products by exercising its authority under TSCA section 6 to: Adopt and apply nationally the California formaldehyde emissions regulation for these composite wood products; and to extend the regulation to include composite wood products used in manufactured homes. For the reasons set forth in this notice, EPA has granted in part and denied in part the petitioners’ requests. FOR FURTHER INFORMATION CONTACT: *For general information contact* : Colby Linter, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)554-1404; e-mail address: *TSCA-Hotline@epa.gov.* *For technical information contact* : Mary Belefski, Chemical Control Division (7405M), Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)564-8461; e-mail address: *belefski.mary@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who manufacture, process, import, or distribute in commerce composite wood products, including hardwood plywood, particleboard, or medium density fiberboard and others who are interested in Agency activities involving formaldehyde. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Get Information About This Petition? EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPPT-2008-0267. All documents in the docket are listed in the docket's index available at *http://www.regulations.gov* . Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at *http://www.regulations.gov* , or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is
(202)566-1744, and the telephone number for the OPPT Docket is
(202)566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. II. Background A. What is a TSCA Section 21 Petition? Section 21 of TSCA allows any person to petition EPA to initiate a rulemaking proceeding for the issuance, amendment, or repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth the facts that are claimed to establish the necessity for the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for the denial in the **Federal Register** . A petitioner may commence a civil action in a U.S. district court to compel initiation of the requested rulemaking proceeding within 60 days of either a denial or the expiration of the 90-day period. B. What Criteria Apply to a Decision on a TSCA Section 21 Petition? 1. *Legal standards regarding TSCA section 21 petitions* . Section 21(b)(1) of TSCA requires that the petition “set forth the facts which it is claimed establish that it is necessary” to issue the rule or order requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 implicitly incorporates the statutory standards that apply to the requested actions. In addition, TSCA section 21 establishes standards a court must use to decide whether to order EPA to initiate rulemaking in the event of a lawsuit filed by the petitioner after denial of a TSCA section 21 petition. 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA has relied on the standards in TSCA section 21 and in the provisions under which actions have been requested to evaluate this petition. 2. *Legal standard regarding TSCA section 6 rules* . In order to promulgate a rule under TSCA section 6(a), the Administrator must find that ‘‘there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture . . . presents or will present an unreasonable risk.’’ 15 U.S.C. 2605(a). This finding cannot be made considering risk alone. In promulgating any rule under TSCA section 6(a), the statute requires that the Administrator consider: • The effects of such substance or mixture on health and the magnitude of the exposure of human beings to such substance or mixture. • The effects of such substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture. • The benefits of such substance or mixture for various uses and the availability of substitutes for such uses. • The reasonably ascertainable economic consequences of the rule, after consideration of the effect on the national economy, small business, technological innovation, the environment, and public health. 15 U.S.C. 2605(c)(1). Furthermore, the control measure or measures adopted are to be the ‘‘least burdensome requirements’’ that adequately protect against the unreasonable risk. 15 U.S.C. 2605(a). Section 21(b)(4)(B) of TSCA provides the standard for judicial review should EPA deny a request for rulemaking under TSCA section 6(a): ‘‘If the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that ... there is a reasonable basis to conclude that the issuance of such a rule ... is necessary to protect health or the environment against an unreasonable risk of injury,’’ the court shall order the Administrator to initiate the requested action. 15 U.S.C. 2620(b)(4)(B). C. What Action is Requested Under this TSCA Section 21 Petition? On March 24, 2008, the Sierra Club, National Center for Healthy Housing, National Coalition to End Childhood Lead Poisoning, Alliance for Healthy Homes, National Housing Institute, Healthy Building Network, Gulf Coast Environmental Restoration Task Force of Sierra Club, Next Generation Choices Foundation, Improving Kids’ Environment, EarthRose Institute, Grassroots Environmental Education, Healthy Homes of Louisiana, Lower Mississippi Riverkeeper, Women’s Community Cancer Project, Gulf Coast D’Iberville Volunteers Foundation, Advocates for Environmental Human Rights, Environmental Health Watch, North Gulfport Community Land Trust, Louisiana Environmental Action Network, Allergy and Environmental Health Assoc., Aspen River Construction, DeVany Industrial Consultant, Protect Sacred Sites ‘‘Indigenous People, One Nation,’’ United People of the Cherokee Nation, Clean Air Athens, and approximately 5,000 individuals petitioned EPA under TSCA section 21. The petitioners are concerned about risks to human health from exposure to formaldehyde emitted from composite wood products, including hardwood plywood, particleboard, and medium density fiberboard. They petitioned EPA to assess and reduce these risks by exercising its authority under TSCA section 6 to: 1. Adopt and apply nationally the formaldehyde emissions regulation (Airborne Toxics Control Measure (ATCM)) for three types of composite wood products (hardwood plywood, particleboard, and medium density fiberboard), recently adopted by the California Air Resources Board (CARB). 2. Extend the regulation to include composite wood products used in manufactured housing. Among other requirements, the CARB ATCM specifies cap emission limits that are not to be exceeded. In this notice, unless otherwise specified, “composite wood products” refers to the three types of wood products (hardwood plywood, particleboard, and medium density fiberboard) referred to in the California regulation. Composite wood products are a subset of “pressed wood products.” D. What Support Do the Petitioners Offer for These Requests? To support their request, the petitioners referenced CARB’s webpage containing the documentation supporting the composite wood products rulemaking. In addition, petitioners cited information available from Federal agencies including the following: 1. U.S. Department of Housing and Urban Development (HUD), Office of Manufactured Housing Programs, and HUD’s formaldehyde emission control regulations at 24 CFR 3280.308. 2. The U.S. EPA National Emission Standards for Hazardous Air Pollutants: Plywood and Composite Wood Products at 40 CFR part 63, subpart DDDD regulation. 3. The U.S Occupational Safety and Health Administration, Formaldehyde Standards for Toxic and Hazardous Substances, 29 CFR 1910.1048. 4. The U. S. Centers for Disease Control and Prevention
(CDC)analyses and findings on formaldehyde in the Federal Emergency Management Agency’s
(FEMA)Hurricane Katrina trailers. The petitioners also summarized in their submission the findings on exposure levels from the CDC trailer study. III. Comments Received In response to EPA’s request for comment on this TSCA section 21 petition (73 FR 22369, April 25, 2008) (FRL-8362-6), EPA received 25 comments. Three were short comments in support of the petition from concerned citizens and furniture manufacturers; one additional furniture manufacturer commented on his concern about effective enforcement against furniture importers. Another comment cautioned that developing a compliance testing method may be very difficult. Eight manufactured housing trade groups and suppliers submitted similar comments opposed to EPA regulation of manufactured homes. The commenters stated that the HUD’s standards have not been shown to be inadequate, HUD has the appropriate statutory authority (and EPA should use TSCA section 9 to refer the matter to HUD), and HUD has already received recommendations to amend its standards. Five furniture, window, door, and general manufacturing trade groups indicated their support for national application of formaldehyde emission standards, but noted that several challenges to the implementation and enforcement of California's rule still need to be worked out. Some indicated support for EPA development of a “performance-based standard” designed to reduce human exposure to formaldehyde, regardless of source (mentioning carpet and paints as other sources of formaldehyde exposure) and all were concerned about the administrative burdens of the CARB rule and California’s or EPA’s ability to manage the certification and testing requirements. Three plywood and composite panel trade groups indicated support for expanding CARB’s emission limits to the rest of the United States, but commented that a TSCA section 6 rule is neither appropriate nor justifiable. They suggest that a national standard would be “developed in a cooperative effort with industry” rather than through a TSCA section 6 rule. The Hardwood Plywood & Veneer Association
(HPVA)stated that it would be willing to join the Manufactured Housing Institute to petition HUD to adopt the CARB standards, and is considering incorporating the CARB emission standards into their next revision of the American National Standards Institute-HPVA standards for hardwood plywood and engineered hardwood flooring. The American Forest & Paper Association commented that it “supports adoption by EPA of the ATCM emission standards and testing and labeling provisions as a single, national paradigm for formaldehyde in composite wood panels, but developed in a cooperative effort with industry rather than through an (unjustified) Section 6 rule.” The Composite Panel Association
(CPA)estimated that 80% of their members’ medium density fiberboard and particleboard production will be CARB-compliant, and CPA expects the CARB rule to become a de facto national standard. However, since compliance with the Phase 2 standards will be significantly more expensive, CPA commented that there will be a greater incentive to differentiate panel emission level by region or customer. CPA also noted that the industry estimates that the costs of the CARB rule, nationwide, will be close to $650 million, significantly higher than the cost to affected parties predicted by California (commenters stated that CARB’s cost estimate was $147 million, but it is actually $127 million). HPVA and CPA also noted concerns about the ability of California or the EPA to enforce the regulation against importers of panels and finished products, and suggested that imports may be a main source of higher emitting panels and finished products. Comments were also received from a formaldehyde trade group and from a resin manufacturer. Hexion, a “major global supplier of thermosetting adhesives,” opposed EPA using section 6 to adopt the California rule, but “could support a national, preemptive regulation limiting formaldehyde emissions from composite wood products . . .” The Formaldehyde Council, Inc.
(FCI)disagreed with the idea that there is no safe level of exposure to formaldehyde. FCI also commented that the average level detected in the FEMA trailers does not typically cause sensory irritation, and cited a study of conventional homes, finding an average formaldehyde concentration of 0.37 parts per million
(ppm)(370 parts per billion (ppb)), in which the occupants had not complained of irritation. They also cited studies that show sensory irritation thresholds of 0.5 ppm (500 ppb), and up to 0.9 ppm (900 ppb) for unsensitized people, and asserted that the empirical support for the studies that the International Agency for Research on Cancer
(IARC)relied on to recategorize formaldehyde has been “steadily eroded.” The Sierra Club commented on the TSCA section 6(c) factors and suggested that EPA consider cost factors associated with remediating the problems in the FEMA trailers. They suggested that EPA estimate the effect on the national economy by a simple mathematic extrapolation from the costs estimated by California and argue that adopting the ATCM would spur technological innovation and have a positive impact on human health and the environment. HUD commented that it received (prior to EPA’s receipt of this petition) a proposal to lower formaldehyde emissions limits from certain products used in the construction of manufactured homes from the Congressionally established Federal Advisory Committee, the Manufactured Housing Consensus Committee (MHCC). In addition, the MHCC recently received a new proposal from the public to adopt the CARB standard. HUD commented that it will work with the MHCC to review the new proposal regarding CARB levels. A supplemental comment was received from HUD on June 19, 2008, and is in the docket. On June 13, 2008, EPA received an additional comment from CPA, summarizing new developments since they submitted their first comment. As also noted in their first comment, CPA is accredited by the American National Standards Institute
(ANSI)as a standards developer. On June 3, 2008, the CPA Board of Directors “approved the insertion of the CARB Phase 1 and Phase 2 formaldehyde emission limits” into the new versions of the ANSI standards for Particleboard (ANSI A208.1) and for Medium Density Fiberboard (ANSI A208.2). When the standards are finalized, “companies would be able to reference either of those levels from these voluntary standards in their commercial dealings.” A consensus committee must still approve the revised standard. A supplemental comment was also received from HPVA on June 17, 2008, and is in the docket. IV. Disposition of Petition For the purpose of making its decision, EPA evaluated the information presented or referenced in the petition and its authority and requirements under TSCA sections 6 and 21. EPA also evaluated comments submitted and relevant information that was otherwise available to EPA during the 90-day petition review period. On the basis of the significant differences in the legal standards applicable to the California Health and Safety Code (H&SC) and TSCA section 6, and the insufficiency of the information available to EPA for purposes of conducting the TSCA section 6 analysis, EPA is not granting the specific request in the petition to commence a proceeding under TSCA section 6 to impose the CARB formaldehyde ATCM nationwide. Even if the information available to EPA were sufficient to support an evaluation of whether formaldehyde in composite wood products presents or will present an unreasonable risk, petitioners have not provided sufficient information, and EPA does not otherwise have sufficient information, to evaluate whether the CARB ATCM would likely be the least burdensome alternative necessary to protect adequately against such risk. However, EPA has decided to initiate a proceeding to investigate whether and what type of regulatory or other action might be appropriate to protect against risks posed by formaldehyde emitted from pressed wood products. The discussion that follows provides the reasons for EPA’s decisions to grant this petition in part and to deny it in part. A. EPA is Not Granting the Petitioners’ Specific Requests 1. *Differences between California’s authority under State law, and EPA’s authority under TSCA* . The petition requests that EPA use authorities under section 6 of TSCA to “adopt the California rules and apply them nationally,” and apply them to composite wood products used in manufactured housing (Ref. 1). The authority under which the State of California issued its ATCM is quite distinct from the regulatory authority granted to EPA under TSCA, however, and EPA has determined that its authority under section 6 of TSCA does not permit it to simply adopt the California formaldehyde ATCM and impose these regulatory controls as a Federal standard without independently determining that formaldehyde in the relevant materials presents or will present an “unreasonable risk” under TSCA section 6(a). Neither the CARB rulemaking record nor other information available to EPA is adequate to support an evaluation of whether the use of formaldehyde in composite wood products presents or will present an unreasonable risk. CARB’s authority to regulate formaldehyde is discussed on pages 2-3 of CARB’s “Initial Statement of Reasons” (ISOR), which was used to support its rulemaking (Ref. 2). According to the statement of authority in the ISOR, CARB asserted jurisdiction to regulate formaldehyde in composite wood products under the California H&SC. The H&SC authorizes CARB to control emissions of criteria pollutants and precursors from source categories. In addition, CARB is authorized to regulate toxic air contaminants
(TACs)under that portion of the H&SC known as the Tanner Act. In 1992, CARB identified formaldehyde as a TAC “based primarily on the determination that it was a human carcinogen with no known safe level of exposure” (Ref. 2). According to the ISOR, CARB’s formaldehyde ATCM was issued principally under the Tanner Act on the basis of formaldehyde being a TAC. Because CARB had identified formaldehyde as a TAC “with no identified ‘safe’ threshold exposure level,” it was required by the Tanner Act “to reduce emissions of the TAC to the lowest level achievable through application of BACT (best available control technology) or a more effective control method.” The TSCA section 6 authority specifically requested by the petition to be used to adopt and apply nationally the CARB ATCM is significantly different from CARB’s authority under the H&SC. As discussed in Unit II.B.2., under TSCA section 6(a), EPA must make a finding that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical presents or will present an unreasonable risk of injury to health or the environment in order to promulgate a TSCA section 6(a) rule. The CARB rulemaking record does not analyze the issues in these terms because CARB does not have to make an unreasonable risk finding under the California H&SC. TSCA section 6(a) identifies the actions that may be taken to protect against unreasonable risk, but does not prescribe a particular minimum control measure as California’s law prescribes BACT. If EPA finds that there is a reasonable basis to conclude that one or more activities presents an unreasonable risk, EPA may: • Prohibit or limit manufacture, processing, or distribution in commerce; • Prohibit or limit the manufacture, processing, or distribution in commerce of the chemical above a specified concentration; • Require adequate warnings and instructions with respect to use, distribution, or disposal; • Require recordkeeping; • Prohibit or regulate any manner of commercial use; • Prohibit or regulate any manner of disposal; or • Require manufacturers or processors to give notice of the unreasonable risk of injury. TSCA section 6(a) also states that EPA must determine which one or more of the risk management options set forth in the statute are the least burdensome means of adequately protecting against the risk. The CARB rulemaking record was constructed to support the single option (BACT or more effective control method) available under the California H&SC, and not for choosing from the multiple options available under TSCA. The California H&SC also does not require that CARB choose the least burdensome means of protecting adequately against the risk. 2. *Information in the petition and otherwise available to EPA is inadequate to support an unreasonable risk evaluation under TSCA* . Notwithstanding the substantial amount of information submitted by reference with the petition or otherwise available to the Agency, EPA has determined that this information is not sufficient to support an evaluation of whether formaldehyde emitted from composite wood products presents or will present an unreasonable risk to human health (including cancer and non-cancer endpoints) under TSCA section 6. Applying the TSCA section 6(a) and 6(c) requirements to the information provided by the petitioners reveals significant information gaps that would need to be filled to support an evaluation of whether use of formaldehyde in composite wood products presents or will present an unreasonable risk. EPA briefly summarizes its reasoning in this unit. a. *Health risks and exposure* . With respect to health risks, the petition refers to the CARB record and to the CDC study on FEMA trailers, thus looking at both cancer risk and irritation risk. CARB based their health effects evaluation on cancer risk. In 1992, CARB identified formaldehyde as a TAC “based primarily on the determination that it was a human carcinogen with no known safe level of exposure” (Ref. 2). CARB also cites for support the higher (hazard) classification of formaldehyde as “Group 1, Carcinogenic to humans” by the International Agency for Research on Cancer
(IARC)(Ref. 2, p. 155, see also Ref. 3). CARB’s analysis was dependent on its determination of formaldehyde as a human carcinogen and its assumptions and analyses that rely on animal data and use two different kinds of models, the linearized multi-stage model and a model which takes into account the proliferation of premalignant cells, for quantification of the cancer risk. In this analysis CARB relied upon the animal data considered by EPA in its 1991 analysis and applied an additional model which places the result somewhere between that of EPA’s 1991 assessment and that of the Chemical Industry Institute of Toxicology’s
(CIIT)biologically based dose response
(BBDR)approach used in EPA in 2004 (discussed in this unit). Given the recent availability of human cancer data which may provide the basis of a more appropriate quantification of human cancer risk, EPA questions the adequacy of the CARB approach and for this reason as well as other reasons discussed in this unit, EPA has determined that it is not able to rely on CARB’s cancer risk assessment. EPA has previously assessed formaldehyde’s cancer risk. In 1991, EPA classified formaldehyde as a B1, probable human carcinogen, “based on limited evidence in humans, and sufficient evidence in animals” (Ref. 4). Increased incidences of nasal squamous cell carcinomas were observed in long-term inhalation studies in rats and mice. Based on the nasal cavity cancer data in rats and using a linearized multi-stage procedure (for genotoxic effects), EPA calculated an inhalation cancer unit risk/potency factor of 1.3 E-5 per microgram/meter cubed (μg/m 3 ) (Ref. 4). As explained in this unit, the assessment and modeling procedure used to develop EPA’s cancer risk assessment is not based on the most current information, and EPA may determine that the appropriate unit risk/potency factor is higher or lower than the 1991 value, after considering the currently available scientific information, including human data. CIIT developed a health risk assessment for formaldehyde based upon animal toxicology data that utilized mechanistic and biological response information to develop a dose response model for the risk of squamous cell carcinoma in the respiratory tract (Ref. 5). The resulting BBDR model was published in the peer reviewed literature (Refs. 6-8). The cancer estimates obtained with the BBDR model are generally 2-3 orders of magnitude lower than corresponding estimates obtained with the linearized multistage procedure. In 2004, EPA’s Office of Air and Radiation
(OAR)determined that the CIIT’s BBDR model was the most appropriate tool to assess the potential cancer risk associated with formaldehyde emissions to the atmosphere (Refs. 9-11). In the Plywood and Composite Wood Products National Emission Standard for Hazardous Air Pollutants (NESHAP), which was issued in 2006, OAR stated “In the case of formaldehyde, we have determined that the cancer potency derived using the approach developed by CIIT, which has been peer reviewed by an external review panel sponsored by EPA and the Canadian government, represents an appropriate alternative to EPA's current IRIS URE for formaldehyde. Therefore, this potency represents the best available peer-reviewed science at this time.” (Ref. 10, p. 8348). In April 2008, the EPA Office of Pesticide Programs
(OPP)issued a preliminary risk assessment of formaldehyde for the reregistration eligibility decision
(RED)as part of Phase 3 of a modified, 4-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration decisions (Ref. 12). Through the reregistration program, EPA is ensuring that all pesticides meet current health and safety standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). In this preliminary risk assessment, OPP decided to present the formaldehyde cancer risks as a range using both the 1991 EPA assessment and the CIIT BBDR model (Ref. 15). This approach, which recently underwent public comment, brackets a range of cancer risk estimates that span about three orders of magnitude (or a factor of a thousand), and depending on which value is being considered suggests potentially significant risk at one end and potentially insignificant risk at the other. In addition to these assessments, IARC, in their reevaluation of epidemiologic studies, concluded that there was “sufficient epidemiological evidence that formaldehyde causes nasopharyngeal cancer in humans,” and upgraded formaldehyde to “Group 1, carcinogenic to humans” from “Group 2A, probably carcinogenic to humans” (Ref. 3). In addition, IARC concluded that “there is strong but not sufficient evidence for a causal association between leukemia and occupational exposure to formaldehyde” (Ref. 3). With these new human data, and considering the other available data, EPA’s Office of Research and Development
(ORD)is currently engaged in a re-assessment/update of the potential cancer and non-cancer risks of formaldehyde through the ORD Integrated Risk Information System
(IRIS)program. An external peer review draft of this assessment is expected to be released in 2009. EPA offices which may be considering or are actively regulating formaldehyde, including the Office of Pollution Prevention and Toxic Substances (OPPTS), will coordinate and proceed accordingly once the assessment is finalized. As discussed previously, because of the uncertainties in estimating formaldehyde’s cancer risks, and the ongoing development of the science with respect to cancer characterization and risk estimation based on the new human data, EPA has determined that it cannot rely on the CARB cancer assessment and believes it would be premature to render judgment on this complex issue for TSCA section 6 purposes. Thus, EPA does not believe that it has information sufficient to support an evaluation of whether formaldehyde in composite wood products presents or will present an unreasonable risk. In addition, in the chronic exposure analysis for composite wood, the CARB rulemaking record makes assumptions that are not believed to be reasonable for use in an EPA risk assessment. For example, CARB assumed that individuals will live in new houses (and have associated elevated formaldehyde exposures) for 70 years. Their analysis did not account for formaldehyde concentration decay over time in new home environments, and they assumed all time spent indoors is spent at the same average formaldehyde concentration as at home, and that all time at home is spent indoors (Ref. 13). With respect to irritation risk, the CDC study on FEMA trailers cited by petitioners provides data on exposure to formaldehyde in trailers, but does not provide a risk analysis. CARB did not rely on irritation risks for their decision to regulate formaldehyde emissions from composite wood products. For these reasons, EPA believes that the information available on health risks (including cancer and non-cancer effects) and exposure is not adequate to support an unreasonable risk evaluation. b. *Economics* . The economic analysis supporting CARB’s ATCM is inadequate to support an evaluation of whether formaldehyde in composite wood products presents or will present an unreasonable risk. In its ISOR, CARB quantified some of the costs and benefits for the ATCM, but not all of the costs or any non-cancer benefits. The ISOR estimated, for example, the cost for industry to comply with the ATCM using various substitute resin systems and discussed the characteristics, advantages, and disadvantages of these substitutes, as well as their effectiveness in reducing formaldehyde emissions from composite wood products. The ISOR cost estimate was based on the cost to purchase substitute resins and on the longer processing times required to manufacture composite wood products when using certain substitute resins. CARB received public comments on its rulemaking that companies will incur additional costs to manufacture compliant panels due to increased costs for resin additives, new equipment, additional energy usage, or decreased throughput. In responding to these comments, CARB indicated that these costs would not necessarily be incurred, and that it expected future innovations in resin technology would decrease production costs over time. EPA suspects that the CARB analysis underestimated costs, particularly in the short term. But EPA was not able to assess the full extent of the likely costs based on the information available. For example, the ISOR cost estimate also does not fully reflect other requirements of the ATCM, such as third party certification and labeling. In addition, because data were not available on the quantity of composite wood contained in imported fabricated goods such as cabinets and furniture, the ISOR cost estimates did not reflect the increase in the cost of these goods. Thus, the information submitted provides an inadequate basis for assessing total incremental cost for the ATCM, or for a national version of the ATCM, including certification, labeling, and related activities required by the ATCM. The trade associations representing composite wood product manufacturers have indicated that the CARB limits may have a significant impact on the national markets. For example, CPA estimated that 80% or more of its members’ production nationwide will be compliant with CARB’s requirements. The associations indicated, however, that they could not estimate how foreign manufacturers and importers will respond to the ATCM and that off-shore producers are an issue because they do not participate in the same voluntary compliance programs that are applicable to domestic producers. Furthermore, especially in view of the expected growth in imports of composite wood products and the fabricated goods made from them, the national baseline following the implementation of the CARB rule, which EPA would use as a starting basis in assessing whether there is an unreasonable risk, is uncertain (Ref. 13). In addition to cancer benefits, the ATCM may result in benefits from avoided cases of non-cancer effects. The CARB ISOR does not, however, present sufficient information to assess benefits from non-cancer effects. For example, the CARB ISOR mentions a hazard quotient for non-cancer inhalation impacts, but the hazard quotient was not evaluated to estimate the number of people exposed to a hazard quotient above 1, the aggregate length of time that such exposures occur, and the intensity of the exposure over time. In addition, the ISOR did not provide information on the size of the population exposed or the intensity of exposure from composite wood products in remodeled homes, newly purchased furniture, or non-residential settings. The benefits of avoiding irritation effects include reductions in medical costs, individuals’ willingness to pay to avoid the pain and suffering resulting from these effects, and increases in productivity due to a decline in lost work days and school days. The ISOR and the other information available to EPA does not provide sufficient information to estimate the non-cancer benefits. Thus, EPA does not have sufficient information to support an evaluation of the costs and benefits of implementing the ATCM requirements nationwide. 3. *Information in the petition and otherwise available to EPA is insufficient to support an evaluation of whether the CARB rule would be the least burdensome requirement under TSCA* . Even if the information available to EPA were sufficient to support an evaluation of whether formaldehyde in composite wood products presents or will present an unreasonable risk, petitioners have not provided sufficient information, and EPA does not otherwise have sufficient information, to evaluate whether the CARB ATCM would likely be the least burdensome alternative necessary to protect adequately against such risk. The information submitted with the petition does not provide an adequate basis for EPA to evaluate the likely costs and benefits of less burdensome alternatives. This is not surprising, since the CARB rulemaking does not require such an analysis. For example, EPA has no basis to evaluate whether the specific emission levels adopted by CARB would be appropriate levels under TSCA section 6, whether CARB’s cap approach or an average emissions approach would be more appropriate, or whether the additional detailed requirements pertaining to third-party certification and other issues would be appropriate. Several aspects of the CARB ATCM are not in place yet, and EPA is not able to evaluate those aspects. Beyond that, it is entirely possible that some control measure(s) other than the emission cap approach that CARB selected for their ATCM would be appropriate. Especially in view of estimates in the record of nationwide compliance with the ATCM, EPA would want to assess the risk that was likely to remain following compliance with the rule and assess whether one or more of the options under TSCA section 6(a) was more appropriate to address the remaining risk. In summary, information in the petition and otherwise available to EPA, including health effects, exposure, and economic information, is inadequate to support an evaluation of whether there is an unreasonable risk under TSCA. Therefore, EPA is not granting the specific request in the petition to commence a proceeding under TSCA section 6 to impose the CARB formaldehyde ATCM nationwide. B. Additional Considerations Pressed wood products, of which the three composite wood products regulated by CARB are a subset, are a major source of formaldehyde concentrations. Other sources of formaldehyde include smoking, household products, and the use of un-vented, fuel-burning appliances like gas stoves or kerosene space heaters (Refs. 16 and 17). Formaldehyde emissions from pressed-wood products are the highest when these products are new and decline over time. Emissions of formaldehyde will increase as the temperature, humidity, and pressed wood surface area increase (Ref. 13). Several Federal agencies and other entities have regulated or produced guidelines on appropriate air concentrations of formaldehyde. HUD presently limits formaldehyde emissions from plywood and particleboard used in manufactured home construction to 200-300 ppb, and is reviewing proposals to revise those emission limits. Among others, the Agency for Toxic Substances and Disease Registry (ATSDR) has established a Minimal Risk Level
(MRL)chronic value of 0.008 ppm/8ppb; the National Institute for Occupational Safety and Health (NIOSH) has established a Recommended Exposure Limit
(REL)of 0.016 ppm/16ppb (8-hour Time Weighted Average), and of 0.1 ppm/100ppb (15 minute ceiling); and American Conference of Governmental Industrial Hygienists (ACGIH) has established threshold limit value (TLV)-Ceiling of 0.3 ppm/300 ppb (Ref. 13). In March 2008, several Federal agencies, including the Department of Health and Human Services (HHS), CDC, U.S. Department of Homeland Security (DHS), FEMA, and EPA finalized a document entitled: “Formaldehyde Exposure in Homes: A Reference for State Officials to Use in Decision-making,” which summarizes the environmental health related aspects of formaldehyde exposure in homes and references the government standards in occupational settings (Ref. 14). Foreign governments, including Japan and the European Union, have also regulated permissible levels of formaldehyde emissions from composite wood products and other building materials (Ref. 2). EPA previously assessed formaldehyde’s cancer risk based on the nasal cavity cancer data in rats and using a linearized multi-staged procedure (for genotoxic carcinogens) (Ref. 4). EPA is conducting a re-assessment/update of the potential cancer risks of formaldehyde through the Integrated Risk Information System
(IRIS)process that will consider current human data and other data. Depending on concentration, it is well recognized that formaldehyde can be an eye, nose, and throat irritant, even when exposure is of relatively short duration. In the indoor environment, sensory reactions and various symptoms as a result of mucous membrane irritation are potential effects, and, while there are large individual differences in the general population, the differences are even greater when hyper-reactive and sensitized people are included in an analysis. EPA acknowledges that there are uncertainties relating to irritation response levels in humans. In light of information about the hazards of formaldehyde, in combination with the potential for prolonged exposure to potentially problematic levels of formaldehyde by residents in newly constructed housing (Ref. 13), EPA believes it is appropriate, in the Agency’s discretion, to initiate a proceeding to better understand the risks from formaldehyde in pressed wood products (including the three types of composite wood regulated by CARB) and to assess various alternatives that EPA might pursue to address such risks. Most of the exposure information presently available to EPA pertains to formaldehyde emissions from pressed wood products in newly built homes (Ref. 13). While emissions from pressed wood products used in new home construction are themselves significant sources of formaldehyde in indoor air, EPA is interested in what other pressed wood sources contribute significantly to formaldehyde concentrations in indoor air. For example, large renovations projects in existing homes, which include a large amount of new pressed wood products, and microenvironments, such as baby cribs built with pressed wood products, could be important sources of exposure to a large number of children and adults. The available information, guidelines, and regulations span a wide range of permissible formaldehyde levels. EPA believes that it is appropriate to examine these various standards, analyze the risk level for formaldehyde in pressed wood products, and determine the appropriate course of action to reduce risks to human health. C. EPA’s Decision to Initiate a Proceeding to Investigate Formaldehyde in Pressed Wood Products In sum, the petition does not, as required under TSCA section 21, set forth facts sufficient to establish that it is necessary to initiate a proceeding under TSCA section 6(a) to protect human health against an unreasonable risk of injury by applying the CARB regulation on a national basis. Further, the additional relevant information that EPA has identified does not support initiation of the requested proceeding. However, after considering the facts presented by the petitioners (including the California administrative record), information presented by commenters, and other information available to EPA, EPA has decided to initiate a proceeding to investigate whether and what type of regulatory or other action might be appropriate to protect against risks posed by formaldehyde emitted from pressed wood products. In parallel with this effort, EPA’s ORD will be developing and obtaining external peer review for the IRIS assessment of formaldehyde’s cancer and non-cancer risks. OPPTS will coordinate with ORD and other EPA offices as it evaluates risks and options under TSCA, and the results of the IRIS effort will be incorporated into this proceeding if timely available. In addition, the preliminary risk assessment used in the Pesticide Reregistration Program will be considered in the effort to evaluate risks and options under TSCA if timely available, and OPP will also consider the efforts under TSCA, as well as other efforts. In Fall 2008, EPA plans to issue an advance notice of proposed rulemaking
(ANPR)to initiate a proceeding. As part of the ANPR process, EPA will engage stakeholders to contribute to obtaining a better understanding of the available control technologies and approaches, industry practices, and the implementation of CARB’s ATCM. Concurrently, EPA plans to develop and conduct an industry survey and initiate development of an exposure assessment and an irritation concern level that could be used for evaluating emissions standards or other approaches. Subsequently, EPA plans to develop an irritation risk assessment, which will receive the appropriate external review, and quantify costs and benefits. At the conclusion of this work, OPPTS anticipates determining whether it should take action, which may include action under TSCA section 6(a) or TSCA section 6(b), or via the development of a voluntary consensus standard or other approaches. As OPPTS evaluates risks and options under TSCA, OPPTS intends to coordinate its efforts with other interested EPA offices and agencies, as well as engage the public and stakeholders. With respect to the petitioners’ request that EPA use TSCA section 6 to apply the CARB rule to manufactured homes, EPA notes that HUD has regulations governing formaldehyde emission levels from plywood and particleboard materials installed in manufactured homes. (See 24 CFR 3280.308.) HUD is in the process of reviewing proposed changes to these regulations to include medium density fiberboard, among other things. HUD is also currently reviewing a proposal to amend its manufactured housing regulations governing formaldehyde to include the standards set forth in the CARB regulation. Section 9(d) of TSCA provides that the Administrator of EPA shall consult and cooperate with other Federal agencies “for the purpose of achieving the maximum enforcement of [TSCA] while imposing the least burdens of duplicative requirements.” 15 U.S.C. 2608(d). Consistent with this provision, EPA will consult and cooperate with HUD as the two agencies work to address formaldehyde emissions from composite wood products. V. References The following is a list of the documents that are specifically referenced in this notice and placed in the docket that was established under Docket ID number EPA-HQ-OPPT-2008-0267. For information on accessing these documents in the docket, refer to Unit I.B. Some documents may also be accessed directly using the url provided. 1. Sierra Club, 25 other organizations, and approximately 5,000 individuals. Letter from Tom Neltner, Sierra Club, to Stephen Johnson, Administrator, Environmental Protection Agency. Re: Citizen Petition to EPA Regarding Formaldehyde in Wood Products. March 20, 2008. 2. California Environmental Protection Agency Air Resources Board. Proposed Airborne Toxic Control Measure to Reduce Formaldehyde Emissions from Composite Wood Products, Staff Report: Initial Statement of Reasons for Proposed Rulemaking. March 9, 2007. * http://www.arb.ca.gov/ regact/2007/compwood07/compwood07.htm * . 3. International Agency for Research on Cancer (IARC). Formaldehyde. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. International Agency for Research on Cancer. Lyon, France. Meeting on June 2-9, 2004, as published by IARC in 2006. Vol. 88. *http://monographs.iarc.fr/ENG/Monographs/vol88/index.php* . 4. EPA, Office of Research and Development. Formaldehyde. Integrated Risk Information System. 1991. *http://www.epa.gov/iris/links.htm* . 5. Chemical Industry Institute of Toxicology (CIIT). Formaldehyde hazard characterization and dose-response assessment for carcinogenicity by the route of inhalation, revised ed. Chemical Industry Institute of Toxicology, Research Triangle Park, NC. 1999. 6. Conolly, R.B., Kimbell, J.S., Janszen, D., and Miller, F., J. Dose-response for formaldehyde-induced cytotoxicity in the human respiratory tract. Regulatory Toxicology and Pharmacology. 35: 32-43. 2002. 7. Conolly, R.B., Kimbell, J.S., Janszen, D., Schlosser, P.M., Kalisak, D., Preston, J., and Miller, F., J. Biologically-motivated computational modeling of formaldehyde carcinogenicity in the F344 rat. Toxicological Sciences. 75:432-447. 2003. 8. Conolly, R.B., Kimbell, J.S., Janszen, D., Schlosser, P.M., Kalisak, D., Preston, J., and Miller, F., J. Human respiratory tract cancer risks of inhaled formaldehyde: Dose-response predictions derived from biologically-motivated computational modeling of a combined rodent and human dataset. Toxicological Sciences. 82: 279-296. 2004. 9. EPA. National Emission Standards for Hazardous Air Pollutants: Plywood and Composite Wood Products; Effluent Limitations Guidelines and Standards for the Timber Products Point Source Category; List of Hazardous Air Pollutants, Lesser Quantity Designations, Source Category List; Final Rule. **Federal Register** (69 FR 45943, July 30, 2004) (FRL-7634-1). *http://www.epa.gov/ttn/atw/plypart/fr30jy04.pdf* . 10. EPA. National Emission Standards for Hazardous Air Pollutants: Plywood and Composite Wood Products; List of Hazardous Air Pollutants, Lesser Quantity Designations, Source Category List; Final Rule. **Federal Register** (71 FR 8341, February 16, 2006) (FRL-8028-9). *http://www.epa.gov/ttn/atw/plypart/fr16fe06.pdf* . 11. EPA. National Emission Standards for Hazardous Air Pollutants: Plywood and Composite Wood Products; Final Rule. **Federal Register** (72 FR 61060, October 29, 2007) (FRL-8482-2). *http://www.epa.gov/ttn/atw/plypart/fr29oc07.pdf* . 12. EPA. Formaldehyde/Paraformaldehyde Risk Assessments; Notice of Availability and Risk Reduction Options; Notice. **Federal Register** (73 FR 21944, April 23, 2008) (FRL-8360-3). *http://www.epa.gov/fedrgstr/EPA-PEST/2008/April/Day-23/p8684.htm* . 13. EPA. Background Document of Technical Information Relevant to the Disposition of the TSCA Section 21 Petition on Formaldehyde. June 2008. Docket ID number EPA-HQ-OPPT-2008-0267. 14. Department of Health and Human Services, Centers for Disease Control and Prevention, Department of Homeland Security, Federal Emergency Management Agency, and EPA. Formaldehyde Exposure in Homes: A Reference for State Officials to Use in Decision-Making. March 2008. *http://www.cdc.gov/nceh/ehhe/trailerstudy/compendium.htm* . 15. EPA. Formaldehyde: Preliminary Risk Assessment for the Registration Eligibility Decision (RED). DP Barcode: 348474, April 7, 2008. Docket ID number EPA-HQ-OPP-2008-0121. *http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=EPA-HQ-OPP-2008-0121* . 16. CPSC. 1997. An Update On Formaldehyde: 1997 Revision. Consumer Product Safety Commission, Washington, DC, CPSC Doc. #725 *http://www.cpsc.gov/cpscpub/pubs/725.html* . 17. EPA. 2007. Indoor Air Quality (IAQ), Pollutants and Sources of Indoor Air Pollution, Formaldehyde/Pressed Wood Products, Office of Radiation and Indoor Air (ORIA), Indoor Environments Division, Washington, DC, Updated November 14, 2007. *http://www.epa.gov/iaq/formalde.html#Levels%20in%20Homes* . List of Subjects Environmental protection, Composite wood products, Formaldehyde, Housing, Toxic Substance Control Act (TSCA). Dated: June 21, 2008. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E8-14618 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2008-0102; FRL-8369-6] Exposure Modeling Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: An Exposure Modeling Public Meeting
(EMPM)will be held for one day on July 22, 2008. This notice announces the location and time for the meeting and sets forth the tentative agenda topics. DATES: The meeting will be held on July 22, 2008 from 9:00 am to 4:00 pm. To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT , preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. ADDRESSES: The meeting will be held at Environmental Protection Agency, Office of Pesticide Programs (OPP), One Potomac Yard (South Building), 1st Floor South Conference Room, 2777 S. Crystal Drive, Arlington, VA 22202. FOR FURTHER INFORMATION CONTACT: Michael Barrett, Environmental Fate and Effects Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305--6391; fax number:
(703)305-6309]; e-mail address: *barrett.michael@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are required to conduct testing of chemical substances under the Toxic Substances Control Act (TSCA), the Federal Food, Drug and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have nay questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Get Copies of this Document and Other Related Information ? 1. *Docket.* EPA has established a docket for this action under docket ID number EPA-HQ-OPP-2008-0102. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . II. Background On a triannual interval, an Exposure Modeling Public Meeting will be held for presentation and discussion of current issues in modeling pesticide fate, transport, and exposure in support of risk assessment in a regulatory context. Meeting dates and abstract requests are announced through the “empmlist” forum on the LYRIS list server at *https://lists.epa.gov/read/all_forums* /. III. How Can I Request to Participate in this Meeting? You may submit a request to participate in this meeting to the person listed under FOR FURTHER INFORMATION CONTACT . Do not submit any information in your request that is considered CBI. Requests to participate in the meeting, identified by docket ID number EPA-HQ-OPP-2008-0102, must be received on or before July 14, 2008. IV. Tentative Topics for the Meeting 1. General Theme: Terrestrial Modeling 2. Specific Topics: a. Discussion of PlantEX Model b. Overview of T-REX and T-HERPES c. TIM Model (Avian Probabilistic Model) d. Chloropicrin Manufacturing Task Force Presentation on Chain 2-D Model e. Riparian Ecosystem Management Model
(REMM)and Runoff Study to Validate Model f. Fumigant Emission Physical Factors and Measures for Mitigating Exposure Incidences List of Subjects Environmental protection, Modeling, Monitoring, Pesticides, Pest. Dated: June 17, 2008. Arthur Jean Williams, Acting Director, Environmental Fate and Effects Division, Office of Pesticide Programs. [FR Doc. E8-14514 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2006-0341; FRL-8370-4] Modification of the Voluntary Children's Chemical Evaluation Program; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA will hold a public meeting to give the stakeholders in the Voluntary Childrens Chemical Evaluation Program (VCCEP) and interested members of the public an opportunity to comment on the modifications the Agency intends to make to VCCEP. The modifications are based on the responses the Agency received to its request for comment on the implementation of the VCCEP pilot. The modifications will primarily address the timeliness and efficiency issues of the program in order to increase its productivity and ability to provide information to the public on the potential risks to children of exposure to certain chemicals. The meeting will also provide the public with an opportunity to comment on the use of the modified VCCEP approach to address certain data and assessment needs identified in EPA's review of high production volume
(HPV)and mid production volume
(MPV)chemicals under its Chemical Assessment and Management Program (ChAMP). DATES: The meeting will be held on Tuesday, July 22, 2008, from 9 a.m. to 11 a.m. Requests to participate in the meeting must be received on or before July 17, 2008. To request accommodation of a disability, please contact the person listed under FOR FURTHER INFORMATON CONTACT , preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. ADDRESSES: The meeting will be held at the Environmental Protection Agency, 1201 Constitution Ave., NW., Rm. 1153, Washington, DC 20460. Requests to participate in the meeting, identified by docket identification
(ID)number EPA-HQ-OPPT-2006-0341, may be submitted to the technical person listed under FOR FURTHER INFORMATION CONTACT . FOR FURTHER INFORMATION CONTACT: *For general information contact* : Colby Lintner, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)554-1404; e-mail address: *TSCA-Hotline@epa.gov* . *For technical information contact* : Catherine Roman, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)564-8157; e-mail address: *roman.catherine@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of particular interest to those chemical manufacturers (including importers) who produce or import chemical substances that are subject to the Toxic Substances Control Act (TSCA), in particular those chemical manufacturers (including importers) that are sponsoring chemicals in VCCEP, individuals or groups concerned with chemical testing and childrens health, and animal welfare groups. Because other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket* . EPA has established a docket for this action under docket ID number EPA-HQ-OPPT-2006-0341. All documents in the docket are listed in the docket's index available at *http://www.regulations.gov* . Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at *http://www.regulations.gov* , or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is
(202)566-1744, and the telephone number for the OPPT Docket is
(202)566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. 2. *Electronic access* . You may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . II. Background VCCEP was designed to collect health effects, exposure, and risk information on chemicals to which children are likely to be exposed, and to make that information available to the public so the public may better understand the potential health risks to children associated with certain chemical exposures, and to allow EPA and others to evaluate the risks of these chemicals so that mitigation measures may be taken as appropriate. EPA announced VCCEP in December 2000 (Ref. 1) and requested chemical manufacturers and importers to participate in a pilot of the program by voluntarily sponsoring their chemical if it were among those selected by EPA. The pilot began in 2001 when companies volunteered to sponsor their chemicals in response to EPAs request. In 2006, at what was approximately the midpoint in the implementation of the pilot phase of VCCEP, EPA sought to evaluate how well the pilot was meeting the objectives of VCCEP. To that end, EPA requested that the public submit comments on their experience with the pilot phase of VCCEP and its opinions on the progress of the pilot phase to date (Ref. 2). Additionally, EPA developed a list of questions in order to focus comments on certain features of the VCCEP pilot on which the Agency particularly wanted input. The comments EPA received were summarized and made available to the public on the VCCEP website ( *http://www.epa.gov/oppt/vccep* ). Some of the main comments concerned the timeliness and efficiency of the program, the chemicals selected for the pilot program, the use of a tiered approach to testing, and the use of a Peer Consultation process to review chemical assessments. Based on those comments and also internal Agency discussions, EPA has developed a list of modifications that it believes will improve the future performance of VCCEP. Although the VCCEP program will continue to operate primarily as described in the **Federal Register** notice launching the program (Ref. 1), certain modifications to address the main concerns of the Agency, stakeholders and the public are being contemplated by EPA. EPA wants to share and discuss the contemplated modifications with the VCCEP stakeholders and the public and listen to any additional comments. Therefore, EPA will hold a public meeting on July 22, 2008, at EPA headquarters in Washington, DC. The modifications which will be the basis for the discussions at the public meeting are as follows: 1. *Chemical selection* . To address the concern that the chemicals covered in the VCCEP Pilot were a set of particularly well-studied chemicals for which, in most cases, little additional assessment was needed, future VCCEP chemicals will primarily be selected from chemicals that, when assessed as part of ChAMP, are identified as being of special concern and as presenting hazard/exposure data needs that are relevant to characterizing risks to children. (A more detailed description of ChAMP is provided in this unit as well as at ( *http://www.epa.gov/ChAMP)* . Chemicals that also meet the original VCCEP chemical selection criteria which were evidence of presence in human tissues and in relevant environmental media (e.g., indoor air, drinking water, and food) will be a particular focus of future VCCEP activity. 2. *Changes to the assessment approach* . • To ensure timely completion of chemical assessments, specific due dates for sponsor assessment submissions and peer consultations will be established in sponsor commitments, including timelines for responding to follow-up actions/requests. • To bring concerns for potential chemical risks to prompt resolution, EPA will indicate in its Tier 1 Data Needs Decision when it believes it is reasonable to combine Tiers 2 and 3 as used in the VCCEP Pilot into a single tier. EPA recognizes that a three tier approach may be acceptable when the sponsor can demonstrate that it is sound scientifically and that a delay in the public availability of Tier 3 data would not have potential public health impacts. 3. *Peer consultation modifications* . Under the modified approach envisioned by EPA, the following points would be agreed to in advance by EPA and the sponsoring company or the VCCEP approach will not be used for purposes of obtaining needed information. • The peer consultation process will remain the mechanism to review sponsor-generated assessments and the sponsor will be responsible for contracting with an independent third party to manage the peer consultation and will bear the associated financial burdens. • Distinguishing between “data needs” and “data gaps,” which was a useful outcome of the VCCEP Pilot, will be used in VCCEP peer consultations. • So that sponsors can better address concerns identified in the peer consultation before EPA develops a Data Needs Decision, the sponsor will promptly develop revised assessments that respond to issues identified in the Peer Consultation Meeting Report and make them publicly available. The sponsor will amend its assessments within 90 days after the Peer Consultation Meeting Report is made available to them. EPA will use the amended assessments and the Peer Consultation Meeting Report to make its Data Needs Decision within 90 days of receipt of the revised assessments. The sponsor will then have 4 months after the receipt of the Data Needs Decision, as is current practice in the VCCEP Pilot, to decide whether to commit to the next tier of assessment, if necessary. The meeting on July 22, 2008, will also provide the public with an opportunity to comment on the use of the modified VCCEP approach to address certain data and assessment needs identified in EPA's review of HPV and MPV chemicals under ChAMP, including environmental toxicity, environmental fate, and aspects that may go beyond mammalian toxicity. ChAMP was established by EPA as a mechanism to partially address the Security and Prosperity Partnership
(SPP)commitments announced by the United States, Canada, and Mexico in Montebello, Canada in August 2007. These commitments included a number of national and regional commitments to trilateral cooperation in the assessment and management of chemicals in North America. The United States has committed, by 2012, to assess and initiate needed actions on chemicals produced above 25,000 pounds per year (lb./yr.) in the country. High production volume
(HPV)chemicals are manufactured and imported in quantities greater than 1,000,000 lb./yr. and moderate production volume
(MPV)chemicals are manufactured and imported in quantities greater than 25,000 lb./yr. but less than 1,000,000 lb./yr. EPA's ongoing efforts under ChAMP to screen and prioritize the risks of chemicals will be a major component of EPA's efforts to meet its SPP commitments. EPA believes that an adaptation of the modified VCCEP approach could provide a flexible framework to further evaluate certain chemicals identified by EPA in its ChAMP screening-level assessments as presenting special concerns and associated follow-up action involving hazard/exposure data development or assessment. EPA believes that in most instances, the detailed evaluation of SPP follow-up cases under the modified VCCEP approach should generally begin at Tier 1. Sponsor-developed assessments should build on EPA's SPP screening-level assessments, consider EPA recommended follow-up actions (including conducting higher tier tests specifically identified as priorities by EPA on the basis of its initial assessment), and include a more highly developed quantification of exposures. III. How Can I Request to Participate in this Meeting? You may submit a request to participate in this meeting to the technical person listed under FOR FURTHER INFORMATION CONTACT . Do not submit any information in your request that is considered CBI. Requests to participate in the meeting, identified by docket ID number EPA-HQ-OPPT-2006-0341, must be received on or before July 17, 2008. IV. References 1. EPA. Voluntary Children's Chemical Evaluation Program; Notice. **Federal Register** (65 FR 81699, December 26, 2000) (FRL-6758-5). Available on-line at: *http://www.epa.gov/fedrgstr* . 2. EPA. Implementation of the Pilot Voluntary Children's ChemicalEvaluation Program; Request for Comment; Notice. **Federal Register** (71 FR 67121, November 20, 2006) (FRL-8057-1). Available on-line at: *http://www.epa.gov/fedrgstr* . List of Subjects Environmental protection, Chemicals, Child Health. Dated: June 20, 2008. James B. Gulliford Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances [FR Doc. E8-14528 Filed 6-26-08; 8:45 am] BILLING CODE 6560-50-S FARM CREDIT ADMINISTRATION Farm Credit Administration Board; Amendment to Sunshine Act Meeting AGENCY: Farm Credit Administration. SUMMARY: Pursuant to the Government in the Sunshine Act (5 U.S.C. 552b(e)(3)), the Farm Credit Administration gave notice on June 24, 2008 (73 FR 35687) of the regular meeting of the Farm Credit Administration Board (Board) scheduled for July 10, 2008. This notice is to amend the agenda by adding an item to the open session of that meeting. FOR FURTHER INFORMATION CONTACT: Roland E. Smith, Secretary to the Farm Credit Administration Board,
(703)883-4009, TTY
(703)883-4056. ADDRESSES: Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. SUPPLEMENTARY INFORMATION: This meeting of the Board was open to the public (limited space available). In order to increase the accessibility to Board meetings, persons requiring assistance should make arrangements in advance. The agenda for July 10, 2008, is amended by adding the following item to the open session as follows: Open Session A. Reports • Effects of the Midwest Flooding Dated: June 20, 2008. Roland E. Smith, Secretary, Farm Credit Administration Board. [FR Doc. 08-1396 Filed 6-25-08; 12:47pm]
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  • 5 USC 601-612
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  • 44 USC 3501-3520
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  • 80 Stat. 308
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