2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document for the public, FDA advisory committee members, and FDA staff entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA procedures regarding public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The draft guidance announced in this notice supersedes FDA's ``Draft Guidance on Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees,'' dated January 2002.

The Federal Transit Administration (FTA) and the Los Angeles County Metropolitan Transportation Authority (LACMTA) issue this early scoping notice to advise other agencies and the public that they intend to explore, in the context of the Council on Environmental Quality's early scoping process, alternative means of improving transit capacity and service in the Eastside Extension Phase II Transit Corridor of Los Angeles, California. The early scoping process is part of a planning Alternatives Analysis (AA) required by Title 49 United States Code (U.S.C.) Sec. 5309, that will lead to the selection of the proposed action and alternatives that will be subject to the appropriate environmental process. Early scoping meetings have been planned and are announced below. The Eastside Extensive Phase II Transit Corridor is east-west oriented and includes all or portions of the cities of Montebello, Pico Rivera, Monterey Park, Industry, Downey, Whittier, Commerce, Rosemead, South El Monte, South San Gabriel, Sante Fe Springs, Bell as well as unincorporated portions of the County of Los Angeles. The study area generally extends from Union Station in downtown Los Angeles, north to the Interstate 10 freeway, east to approximately three miles east of the State Route 605, and south to Interstate 5 freeway. The Alternatives Analysis will study the extension of high capacity transit service from the Metro Gold Line Eastside Extension to approximately 3 miles east of the State Route 605. The conclusion of the planning Alternatives Analysis is expected to be the selection of a Locally Preferred Alternative (LPA) by the LACMTA and the Southern California Association of Governments, which is the official metropolitan planning organization for Los Angeles. The LPA will then be the ``proposed action'' that is subject to an appropriate environmental review under the National Environmental Policy Act (NEPA). If the selected LPA would have significant impacts, an environmental impact statement (EIS), combined with a California environmental impact report (EIR) would be initiated with a Notice of Intent in the Federal Register and distribution of a Notice of Preparation (NOP) required under the California Environmental Quality Act (CEQA). Public and agency scoping of the EIS/EIR would be conducted at that time. In particular, the purpose and need for the project, the range of alternatives to be considered in the EIS/EIR, the environmental and community impacts to be evaluated, and the methodologies to be used, would be subject to public and interagency review and comment, in accordance with 23 U.S.C. 139 and CEQA.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

On October 10, 2007, the Federal Register published a Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS) for the Motorized Travel Management Plan on the Apache-Sitgreaves National Forests (72 FR 57514-57517). That document indicated that the proposed transportation system is depicted in detail on the Apache-Sitgreaves National Forests Travel Management Plan Proposed Action Map located on the Forests Web site and that the Forests transportation system open to motorized travel under this proposal would be approximately 2,892 miles. Correction of both of these statements is necessary. Correction: In the Federal Register of October 10, 2007, in FR Doc. 72-195, on page 57515, correct the proposed Action caption, second column, last paragraph, first and second sentence to read:

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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.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995 (PRA), Public Law No. 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. Subject to the PRA, no person shall be subject to any penalty for failing to comply with a collection of information that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

Notice is hereby given that NMFS Southwest Fisheries Science Center (Lisa Ballance, Responsible Official), 8604 La Jolla Shores Drive, La Jolla, CA 92038 has been issued a permit to take green (Chelonia mydas), loggerhead (Caretta caretta), and olive ridley (Lepidochelys olivacea) sea turtles for purposes of scientific research.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of acute bacterial sinusitis (ABS). The agency's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of our current thinking in this area. In addition, it will fulfill a statutory requirement to publish such a guidance enacted in the Food and Drug Administration Amendments Act of 2007 (FDAAA).

NMFS publishes Fraser River salmon inseason orders to regulate salmon fisheries in U.S. waters. The orders were issued by the Fraser River Panel (Panel) of the Pacific Salmon Commission (Commission) and subsequently approved and issued by NMFS during the 2007 salmon fisheries within the U.S. Fraser River Panel Area. These orders established fishing dates, times, and areas for the gear types of U.S. treaty Indian and all citizen fisheries during the period the Panel exercised jurisdiction over these fisheries.

Pursuant to Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA) and regulations implemented by the Council on Environmental Quality (40 C.F.R. Parts 1500-1508), and Presidential Executive Order 12114, Environmental Effects Abroad of Major Federal Actions, 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 October 19, 2007. This EIS/OEIS evaluates the environmental effects for the shock trial of the MESA VERDE (LPD 19) at a site offshore of either Norfolk, Virginia; Mayport, Florida; or Pensacola, Florida. A Notice of Intent for this DEIS/OEIS was published in the Federal Register on March 12, 2004. The Navy will conduct three public hearings to receive oral and written comments on the Draft EIS/OEIS. Federal, State, 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.

The North Pacific Fishery Management Council's (Council) Non- Target Species Committee will meet at the offices of At-Sea Processors Association.

In accordance with section 113(g) of the Clean Air Act, as amended (``Act''), 42 U.S.C. 7413(g), notice is hereby given of a proposed modification to a consent decree, to address a lawsuit filed by Environmental Defense: Environmental Defense v. Environmental Protection Agency, No. C 05 2090 (N.D.Cal.). On June 6, 2005, plaintiff Environmental Defense filed a complaint claiming that EPA had failed to perform a nondiscretionary duty to either grant or deny, within eighteen months of receipt, an August 11, 2003 petition submitted to EPA by Environmental Defense asking the Administrator to list diesel engine exhaust as a hazardous air pollutant under section 112(b)(3) of the Clean Air Act, 42 U.S.C. 7412(b)(3). Under the terms of the initial consent decree, EPA agreed to sign a notice for publication in the Federal Register that contained either a proposal to grant (in whole or in part) or a final determination that denies the petition by June 12, 2006. If EPA proposed to grant the petition, then EPA agreed to sign a final notice for publication in the Federal Register either granting or denying (in whole or in part) the petition by May 1, 2007. The original deadlines have been extended to January 7, 2008 and April 2, 2008, respectively, as a result of previous modifications to the original consent decree. Under the terms of the proposed modification, the deadlines above would be changed, respectively, to August 11, 2010 and May 11, 2011. However, EPA will not have to act on Environmental Defense's petition if EPA signs a notice for publication in the Federal Register of a proposed rule proposing to establish emissions standards for the emission of hazardous air pollutants from existing non- emergency stationary diesel engines of 300 horsepower or greater manufactured prior to 1996 pursuant to section 112 of the Clean Air Act, 42 U.S.C. 7412 by February 25, 2009, and signs a notice for publication in the Federal Register of a final rule establishing emission standards for such engines by February 10, 2010.

We are adopting as a final rule, without change, an interim rule that amended the export certification regulations to clarify that an International Standards for Phytosanitary Measures No. 15 (ISPM 15) quality/treatment mark is an industry-issued certificate and thus may be issued only when the organization applying the mark has entered into an agreement with the Animal and Plant Health Inspection Service. The interim rule also removed all references to a certificate of heat treatment from the regulations because such certificates have been replaced by the ISPM 15 quality/treatment mark. The interim rule was necessary to ensure the appropriate issuance of the ISPM 15 quality/ treatment mark.

EPA is proposing to find that the Baton Rouge marginal 8-hour ozone nonattainment area has failed to attain the 8-hour ozone national ambient air quality standard (NAAQS or standard) by June 15, 2007, the attainment deadline set forth in the Clean Air Act (CAA) and Code of Federal Regulations (CFR) for marginal nonattainment areas. If EPA finalizes this finding, the Baton Rouge area will then be reclassified, by operation of law, as a moderate 8-hour ozone nonattainment area. The moderate area attainment date for the Baton Rouge area would then be as expeditiously as practicable but no later than June 15, 2010. Once reclassified, Louisiana must submit State Implementation Plan (SIP) revisions that meet the 8-hour ozone nonattainment requirements for moderate areas, as required by the CAA. In this action, EPA is also proposing the schedule for the State's submittal of the SIP revisions required for moderate areas once the area is reclassified.

The following described 1.25-acre public land parcel near Swan Valley, Bonneville County, Idaho, has been examined and found suitable for title transfer by (non-competitive) direct sale to Dale E. McDowell, Louise J. Prudhomme and George McDowell reserving a conservation easement to the United States. The sale will be conducted under the authority of section 203(f)(2) of the Federal Land Policy and Management Act of 1976, as amended, 43 U.S.C. 1701 et. seq. (FLPMA) and CFR 2711.3-3(a), and will take place according to procedures governing direct sale of public land.

EPA establishes national, technology-based regulations known as effluent guidelines and pretreatment standards to reduce pollutant discharges from categories of industry discharging directly to waters of the United States or discharging indirectly through Publicly Owned Treatment Works (POTWs). The Clean Water Act (CWA) sections 301(d), 304(b), 304(g), and 307(b) require EPA to annually review these effluent guidelines and pretreatment standards. This notice presents EPA's 2007 review of existing effluent guidelines and pretreatment standards. It also presents EPA's evaluation of indirect dischargers without categorical pretreatment standards to identify potential new categories for pretreatment standards under CWA sections 304(g) and 307(b). This notice also presents the Preliminary 2008 Effluent Guidelines Program Plan (``preliminary 2008 Plan''), which, as required under CWA section 304(m), identifies any new or existing industrial categories selected for effluent guidelines rulemaking and provides a schedule for such rulemaking. CWA section 304(m) requires EPA to biennially publish such a plan after public notice and comment. EPA is soliciting comment on its preliminary 2008 Plan and on its 2007 annual review of existing effluent guidelines and pretreatment standards and industrial categories not currently regulated by effluent guidelines and pretreatment standards.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Small Business Programs (OSBP) is soliciting comments concerning the proposed continuation of the information collections contained in the Small Business Programs Information Management System. A copy of the proposed information collection request (ICR) can be obtained by contacting the employee listed below in the ADDRESSES Section of this notice.