May 31, 2007 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR which is abstracted below describes the nature of the collection and the estimated burden and cost.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (83) entitled ``Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA.'' This guidance is intended to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) on how they should report certain changes to such applications, in accordance with the final regulation, 21 CFR 514.8, which was issued in the Federal Register of December 13, 2006 (71 FR 74766).

The Western Area Power Administration (Western) is proposing revised rates for Loveland Area Projects (LAP) firm electric service. LAP consists of the Fryingpan-Arkansas Project (Fry-Ark) and the Pick- Sloan Missouri Basin Program (Pick-Sloan)Western Division, which were integrated for marketing and rate-making purposes in 1989. The current rates, under Rate Schedule L-F6, expire on December 31, 2010, but are not sufficient to meet the LAP revenue requirements. The proposed rates will provide sufficient revenue to pay all annual costs, including interest expense, and repay required investment within the allowable period. Western will prepare a brochure that provides detailed information on the proposed rates. The proposed rates, under Rate Schedule L-F7, are scheduled to go into effect on January 1, 2008, and will remain in effect through December 31, 2012. Publication of this Federal Register notice begins the formal process for the proposed rate adjustment.

The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection request is for a three-year extension of its Compliance Statement and Certification Report: Energy or Water Conservation Program for Consumer Products, OMB Control Number 1910-1400, whereby a manufacturer or private labeler reports on and certifies its compliance with energy efficiency standards for consumer appliances covered under Title 10, Code of Federal Regulations, Part 430 (10 CFR Part 430)Energy Conservation Program for Consumer Products.

This notice announces the next meeting of the Community Development Advisory Board (the Advisory Board), which provides advice to the Director of the Community Development Financial Institutions Fund (the Fund).

The U.S. Department of State (Department) is proposing to revise its regulations presently set forth at 22 CFR Part 62, Subpart D (Sanctions) and 22 CFR Part 62, Subpart E (Termination and Revocation of Programs). The revised Sec. 62.50 will retain many, but not all, of the provisions of the current regulations, and modifies the reasons for which sanctions may be imposed. One difference in the proposed regulation is the substitution of a panel of three Review Officers to conduct a ``paper review'' in lieu of a trial-type hearing. This streamlined review process will continue to provide full procedural due process rights. Subpart E, Sec. 62.60 proposes to amend existing regulations to provide for program termination in the case of failure to file an annual management audit, in program categories requiring such audits. A new Sec. 62.62 will provide for termination or denial of redesignation for an entire class of designated programs, if the Department determines that they compromise the national security of the United States, or no longer further the public diplomacy mission of the Department.

The Coast Guard is establishing temporary, moving safety zones on the navigable waters of the San Francisco Bay and Delta Region to contribute to the safety of the boating public where whales have been sighted swimming up river from the San Francisco Bay. These safety zones are established to ensure the safety of persons and vessels from hazards, injury, and damage associated with higher-than-normal levels of recreational boating traffic on the water as individuals attempt to view the whales. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zones without permission of the Captain of the Port or his designated representative.

EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the state of Iowa for the purpose of revising the general emission rate for particulate matter.

This notice announces the availability of draft guidances for industry that describe recommendations on how to design bioequivalence (BE) studies for 200 specific drug products to support abbreviated new drug applications (ANDAs). These draft guidances are being made available concurrently with the publication of a draft guidance for industry entitled ``Draft Guidance for IndustryBioequivalence Recommendations for Specific Products'' (product specific BE recommendations). This draft guidance describes the new process for making available guidance on product-specific BE studies. Under the process described in the draft guidance, draft and final product-specific BE study guidance will be made available on the FDA Web site. FDA believes that making this information available on the Internet will streamline the guidance process and provide a meaningful opportunity for the public to consider and comment on product-specific BE study recommendations. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a related guidance document entitled ``Draft Guidance for Industry Bioequivalence Recommendations for Specific Products.''

The National Energy Technology Laboratory, on behalf of the Office of Energy Efficiency and Renewable Energy's Building Technologies Program, intends to issue a Funding Opportunity Announcement (FOA) to select and fund multiple Energy Efficient Housing Partnership teams under the Building America program.

The NOAA Office of Ocean and Coastal Resource Management (OCRM) announces its intent to evaluate the performance of the Guana Tolomato Matanzas (Florida) National Estuarine Research Reserve, the San Francisco Bay (California) National Estuarine Research Reserve, the Jacques Cousteau (New Jersey) National Estuarine Research Reserve, the Maryland Coastal Management Program, and the Florida Coastal Management Program. The Coastal Zone Management Program evaluations will be conducted pursuant to section 312 of the Coastal Zone Management Act of 1972, as amended (CZMA) and regulations at 15 CFR part 923, Subpart L. The National Estuarine Research Reserve evaluations will be conducted pursuant to sections 312 and 315 of the CZMA and regulations at 15 CFR Part 921, Subpart E and Part 923, Subpart L. The CZMA requires continuing review of the performance of states with respect to coastal program implementation. Evaluation of Coastal Management Programs and National Estuarine Research Reserves requires findings concerning the extent to which a state has met the national objectives, adhered to its Coastal Management Program document or Reserve final management plan approved by the Secretary of Commerce, and adhered to the terms of financial assistance awards funded under the CZMA. Each evaluation will include a site visit, consideration of public comments, and consultations with interested Federal, state, and local agencies and members of the public. A public meeting will be held as part of each site visit. Notice is hereby given of the dates of the site visits for the listed evaluations, and the dates, local times, and locations of the public meetings during the site visits. Dates and Times: The Guana Tolomato Matanzas (Florida) National Estuarine Research Reserve evaluation site visit will be held July 17- 19, 2007. One public meeting will be held during the week. The public meeting will be held on Wednesday, July 18, 2007, at 6 p.m. at the Guana Tolomato Matanzas National Estuarine Research Reserve Environmental Education Center, 505 Guana River Road, Ponte Vedra Beach, Florida. The San Francisco Bay (California) National Estuarine Research Reserve evaluation site visit will be held August 27-30, 2007. One public meeting will be held during the week. The public meeting will be held on Tuesday, August 28, 2007, at 7 p.m. at the Farallon Room, Aquarium of the Bay, Pier 39, The Embarcadero at Beach Street, San Francisco, California. The Jacques Cousteau (New Jersey) National Estuarine Research Reserve evaluation site visit will be held September 11-13, 2007. One public meeting will be held during the week. The public meeting will be held on Wednesday, September 12, 2007, at 7 p.m. at the Jacques Cousteau National Estuarine Research Reserve Coastal Education Center, 130 Great Bay Boulevard, Tuckerton, New Jersey. The Maryland Coastal Management Program evaluation site visit will be held September 10-14, 2007. One public meeting will be held during the week. The public meeting will be held on Monday, September 10, 2007, at 6:30 p.m. at the Maryland Department of Natural Resources, Tawes State Office Building, C-1 Conference Room, 580 Taylor Avenue, Annapolis Maryland. The Florida Coastal Management Program evaluation site visit will be held September 17-21, 2007. One public meeting will be held during the week. The public meeting will be held on Tuesday, September 18, 2007, at 6:30 p.m. at the Florida Department of Environmental Protection, Marjorie Stoneman Douglas Building, Conference Room A, 3900 Commonwealth Boulevard, Tallahassee, Florida.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2005 Honda CR-V multipurpose passenger vehicles that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS) are eligible for importation into the United States because (1) they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards, and (2) they are capable of being readily altered to conform to the standards.

The NIEHS vision is to prevent disease and improve human health by using environmental sciences to understand human biology and human disease. NIEHS has prioritized Global Environmental Health (GEH) as a major initiative of its new strategic plan to implement its vision. To obtain advice and guidance on potential research strategies for global environmental health, the NIEHS held the Global Environmental Health Workshop on January 10, 2007, and now invites public comments on the workshop report.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of the draft economic analysis and draft environmental assessment, the reopening of the public comment period, and a public hearing on the proposed revised designation of critical habitat for the wintering population of the piping plover (Charadrius melodus) under the Endangered Species Act of 1973, as amended (Act). We are reopening the public comment period to allow all interested parties an opportunity to comment simultaneously on the proposed rule and the associated draft economic analysis and draft environmental assessment. The draft economic analysis finds that costs associated with conservation activities for the wintering population of the piping plover in North Carolina are forecasted to range from $0 to $12.2 million in lost consumer surplus and $0 to $21.1 million in lost trip expenditures in undiscounted dollars over the next 20 years, with an additional $32,000 to $79,000 in administrative costs. Discounted impacts are estimated to range from $0 to $6.2 million in lost consumer surplus and $0 to $10.6 million in lost trip expenditures over 20 years using a real rate of seven percent, with an additional $17,000 to $42,000 in administrative costs. This amounts to $0 to $503,000 in lost consumer surplus and $0 to $861,000 in lost trip expenditures, annually. Using a real rate of three percent, discounted impacts are estimated at $0 to $8.9 million in lost consumer surplus and $0 to $15.4 million in lost trip expenditures over the next 20 years, with an additional $24,000 to $59,000 in administrative costs. This amounts to $2,000 to $600,000 in lost consumer surplus and $0 to $1.0 million in lost trip expenditures, annually. The draft environmental assessment finds that designation of critical habitat would not impose any physical alteration of the physical or biological communities used by the wintering population of the piping plover, nor would it alter any social, cultural, or recreational resources or the use of such resources beyond current conditions or existing management strategies. Comments previously submitted need not be resubmitted as they will be incorporated into the public record and fully considered in preparation of the final rule.

Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) is issuing a supplement to the Environmental Assessment (EA) for the Diablo Canyon Independent Spent Fuel Storage Installation (ISFSI) and publishing, for public comment, a draft Finding of No Significant Impact (FONSI). NRC issued the EA and initial FONSI for this action on October 24, 2003, and subsequently issued a license for the Diablo Canyon ISFSI to the Pacific Gas and Electric Company (PG&E), on March 22, 2004. The license authorizes PG&E to receive, possess, store, and transfer spent nuclear fuel and associated radioactive materials resulting from the operation of the Diablo Canyon Power Plant in an ISFSI at the site for a term of 20 years. NRC is issuing this supplement to the EA and draft FONSI in response to the June 2, 2006, decision by the United States Court of Appeals for the Ninth Circuit, San Luis Obispo Mothers for Peace v. NRC, 449 F.3d 1016 (9th Cir. 2006). This supplement to the EA addresses the environmental impacts from potential terrorist acts against the Diablo Canyon ISFSI.

The Food Safety and Inspection Service (FSIS) is announcing the availability of an electronic Web-based version of FSIS Form 10,240-1, Production Information on Post-Lethality Exposed Ready-to-Eat Products. This form is available for the first time for online submission. FSIS Form 10,240-1 will be used to collect information about the ready-to-eat (RTE) products produced by establishments.

This is an amendment of the Presidential declaration of a major disaster for the State of Kansas (FEMA-1699-DR), dated 05/06/ 2007. Incident: Severe Storms, Tornadoes, and Flooding. Incident Period: 05/04/2007 and continuing through 05/18/2007.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intentions to request approval on a new and/or currently approved information collection.

EPA is proposing to update a portion of the Outer Continental Shelf (``OCS'') Air Regulations. Requirements applying to OCS sources located within 25 miles of States' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (``COA''), as mandated by section 328(a)(1) of the Clean Air Act, as amended in 1990 (``the Act''). The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources by the Ventura County Air Pollution Control District (Ventura County APCD). The intended effect of approving the OCS requirements for the Ventura County APCD is to regulate emissions from OCS sources in accordance with the requirements onshore. The change to the existing requirements discussed below is proposed to be incorporated by reference into the Code of Federal Regulations and is listed in the appendix to the OCS air regulations.