2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing hydrocodone bitartrate, or any other salt or ester of hydrocodone (hereinafter collectively ``hydrocodone''), and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved hydrocodone products have been implicated in reports of medication errors, including improper dosing and dispensing the wrong drug. Some of these products omit important labeling warnings and information or are inappropriately labeled for use in young children. Drug products containing hydrocodone are new drugs that require approved applications because they are not generally recognized as safe and effective. Manufacturers who wish to market a drug product containing hydrocodone must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).

The Department of Commerce (the Department) is extending the time limit for the preliminary results of the administrative review on the suspension agreement on cut-to-length carbon steel plate from Russia.

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 settlement agreement, to address a lawsuit filed by Rocky Mountain Clean Air Action (``RMCAA'') in the United States Court of Appeals for the D.C. Circuit: Rocky Mountain Clean Air Action v. EPA, No. 07-1012 (D.C. Cir.). Petitioner filed a petition for review challenging EPA's final rule entitled ``Final Extension of the Deferred Effective Date for 8-Hour Ozone National Ambient Air Quality Standards (``NAAQS'') for Early Action Compact Areas,'' 71 FR 69022 (Nov. 29, 2006). Under the terms of the proposed settlement agreement, deadlines have been established for EPA and the State of Colorado to take specific actions related to the Denver Early Action Compact (``Denver EAC'') area. Petitioner's sole remedy if EPA or the State fails to take one of these actions is to request the court to lift the stay and to set a briefing schedule.

The Environmental Protection Agency (EPA) is proposing to revise EPA's definition of volatile organic compounds (VOCs) for purposes of preparing State implementation plans (SIPs) to attain the national ambient air quality standard for ozone under Title I of the Clean Air Act (Act). This proposed revision would add compounds to the list of compounds excluded from the definition of VOC on the basis that these compounds make a negligible contribution to tropospheric ozone formation. The compounds under consideration are propylene carbonate and dimethyl carbonate. The EPA is inviting comment on an alternative evaluation criteria for exempting one of these compounds (propylene carbonate), methods for tracking changes in the use and emissions of both of these compounds and their potential substitutes, and the potential for health risks that may result from this action.

The Office of the Secretary of Defense is amending two systems of records notices in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

Under Section 10(a)(2) of the Federal Advisory Committee Act, the United States Environmental Protection Agency (EPA) is giving notice of a meeting of the Total Coliform Rule Distribution System Advisory Committee (TCRDSAC). The purpose of this meeting is to discuss the public health information, Safe Drinking Water Act (SDWA) framework, Total Coliform Rule (TCR) implementation and compliance, and issues that may affect finished water quality in distribution systems. The TCRDSAC advises and makes recommendations to the Agency on revisions to the Total Coliform Rule (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 in the meeting include available public health information and how it relates to the TCR; how the TCR relates to other SDWA regulations, such as the Ground Water Rule; TCR implementation and compliance; and information on distribution system issues that may impact water quality.

On August 1, 2007 (72 FR 42134), the Nuclear Regulatory Commission (NRC) announced its acceptance for docketing of the application and notice of opportunity for hearing for the renewal of Operating License Nos. DPR-26 and DPR-64, which authorize Entergy Nuclear Operations, Inc. to operate Indian Point Nuclear Generating Unit Nos. 2 and 3, respectively, at 3216 megawatts thermal (MWt) for each unit. A sixty-day period was provided for the filing of written requests for a hearing or petitions for leave to intervene with respect to the renewal of the license. The period for the filing of requests for a hearing or petitions for leave to intervene was to have expired on October 1, 2007. The period for the filing of requests for a hearing or petitions for leave to intervene has been extended and now expires on November 30, 2007. The period for filling answers to such requests or petitions has also been extended.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to this notice. This notice solicits comments on the information needed to determine the validity of a common law marriage.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to determine a claimant's entitlement to accrued benefits.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to obtain contact information on individuals residing in a remote location.

This document announces that U.S. Customs and Border Protection (CBP) will convene its annual trade symposium, featuring panel discussions involving department personnel, members of the trade community and other government agencies, on the agency's role in international trade initiatives and programs. Members of the international trade and transportation communities and other interested parties are encouraged to attend.

The Federal Emergency Management Agency (FEMA) announces the availability of the Compendium of Flood Map Changes which provides a listing of changes made to the National Flood Insurance Program (NFIP) maps that became effective from January 1, 2005 through June 30, 2007. Future notices of changes to NFIP maps will be made available approximately every 6 months.

At its regular business meeting on September 12, 2007 in Binghamton, New York, the Commission: (1) Convened a panel session on New York State's involvement in the Chesapeake Bay Program, (2) approved a proposed rulemaking action to amend the consumptive use provisions of 18 CFR Part 806 relating to agricultural water use, and (3) approved a grant and four contracts. It also conducted a public hearing to approve certain water resources projects and rescind one docket approval. See the SUPPLEMENTARY INFORMATION section below for more details on these actions.

This document contains proposed rules that would amend project review regulations to clarify the definition of ``agricultural water use'' and to provide a qualified exception to the consumptive use approval requirements for agricultural water use projects. In addition, this proposed rule would make a technical correction to an error in the ``Authority'' citation for Part 808.

In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this document notifies the public of funding awards for Fiscal Year (FY) 2007 Historically Black Colleges and Universities Program. The purpose of this document is to announce the names, addresses and the amount awarded to the winners to be used to help Historically Black Colleges and Universities (HBCUs) expand their role and effectiveness in addressing community development needs in their localities, consistent with the purposes of Title I of the Housing and Development Act of 1974, as amended.

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

This notice is issued in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i). NASA hereby gives notice of its intent to grant an exclusive license in the United States to practice the inventions described and claimed in U.S. Patent No. 6,745,942 B1 and U.S. Patent No. 7,017,812 B1 to QI3 Corporation, DBA Quest Integrated., having its principal place of business in Kent, Washington. The patent rights in this invention have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. NASA has not yet made a determination to grant the requested license and may deny the requested license even if no objections are submitted within the comment period.

Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the National Aeronautics and Space Administration is issuing public notice of its proposal to modify its previously noticed system of records: This notice publishes updates of those systems of records as set forth below under the caption SUPPLEMENTARY INFORMATION.