April 2008 – Federal Register Recent Federal Regulation Documents

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of 5 additional entities and individuals whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (``Kingpin Act'') (21 U.S.C. 1901-1908, 8 U.S.C. 1182).

In response to objections raised, the United States Patent and Trademark Office (``USPTO'') withdraws its prior proposal to amend the Rules of Practice in Trademark Cases to require a request for reconsideration of an examining attorney's final refusal or requirement to be filed through the Trademark Electronic Application System (``TEAS'') within three months of the mailing date of the final action. The USPTO instead proposes to require a fee of $50 for filing a request for reconsideration on paper, whereas no fee would be required for a request for reconsideration filed through TEAS. The proposed fee would cover the USPTO's added costs of processing a request for reconsideration filed on paper, rather than through TEAS. Currently, no fee is required in connection with a request for reconsideration, filed either on paper or through TEAS.

On October 30, 2007, the Canadian National Railway Company (CN) and Grand Trunk Corporation (collectively CN or the Applicants) filed an application with the Surface Transportation Board (Board or STB) seeking the Board's approval to acquire control of EJ&E West (EJ&EW) Company, a wholly owned noncarrier subsidiary of the Elgin, Joliet and Eastern Railway Company\1\ (EJ&E). In their application, Applicants state that they plan to construct six new rail connections and approximately 19 miles of siding extensions and second mainline track (double track). EJ&E is a Class II railroad that currently operates approximately 200 miles of track in northeastern Illinois and northwestern Indiana.

The Federal Emergency Management Agency (FEMA), 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 a continuing information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the need to continue collecting information from individuals and States in order to provide and/or administer disaster assistance through the Federal Assistance to Individuals and Households Program (IHP).

The Bureau of Reclamation (Reclamation) is the National Environmental Policy Act Federal lead agency, and the U.S. Fish and Wildlife Service (Service) and National Marine Fisheries Service (NMFS) are the Federal Cooperating Agencies. The California Department of Water Resources (DWR) is the California Environmental Quality Act State lead agency, and the California Department of Fish and Game (DFG) is the State Responsible and Trustee Agency. Together, these five agencies have prepared a Final Supplemental EIS/EIR for the Environmental Water Account (EWA). The EWA Program provides for fish protection and recovery in the San Francisco Bay/Sacramento-San Joaquin Delta (Delta) while at the same time improving water supply reliability for Central Valley Project (CVP) and State Water Project (SWP) water users. The Draft Supplemental EIS/EIR addressed changes to the regulatory and physical environment that have occurred since completion of the Final EIS/EIR in January 2004 (69 FR 3599) and the Records of Decision in March 2004 and September 2004.

The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies.

We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of revisions to a previously proposed amendment to the Kansas regulatory program (Kansas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The revisions concern newly promulgated Kansas Regulations. Kansas submitted these regulations at its own initiative to meet the requirements for its program to operate under Title IV and V of the Surface Mining Control and Reclamation Act and to make technical and editorial corrections to its program. This document gives the times and locations where the Kansas program and proposed amendment are available for your inspection and the comment period during which you may submit written comments on the revisions to the amendment.

The Adaptive Management Program (AMP) was implemented as a result of the Record of Decision on the Operation of Glen Canyon Dam Final Environmental Impact Statement to comply with consultation requirements of the Grand Canyon Protection Act (Pub. L. 102-575) of 1992. The AMP includes a federal advisory committee (AMWG), a technical work group (TWG), a monitoring and research center, and independent review panels. The AMWG makes recommendations to the Secretary of the Interior concerning Glen Canyon Dam operations and other management actions to protect resources downstream of Glen Canyon Dam consistent with the Grand Canyon Protection Act. The TWG is a subcommittee of the AMWG and provides technical advice and recommendations to the AMWG. Dates and Addresses: The AMWG will conduct the following meeting: Date: Thursday, May 22, 2008. The meeting will begin at 9:15 a.m. and conclude at 5 p.m. on the first day and will begin at 8 a.m. and conclude at 2 p.m. on the second day. The meeting will be held at the Bureau of Indian Affairs, 2 Arizona Center, 400 N. 5th Street, 12th Floor, Conference Rooms A&B, in Phoenix, Arizona. Agenda: The purpose of the meeting will be for the AMWG to receive updates and discuss the following items: (1) Preliminary results from the March 2008 high flow experiment, (2) humpback chub comprehensive plan and recovery plan updates, (3) science symposium planning, (4) 2008 fiscal year expenditures, (5) draft 2009 fiscal year budget, (6) AMP strategic plan revision, (7) next steps for AMP experiments, and (8) other subjects of AMP administration. To view a copy of the draft agenda, please visit Reclamation's Web site at: https://www.usbr.gov/uc/ rm/amp/amwg/mtgs/08may22/. Time will be allowed for any individual or organization wishing to make formal oral comments at the meeting. To allow for full consideration of information by the AMWG members, written notice must be provided to Dennis Kubly, Bureau of Reclamation, Upper Colorado Regional Office, 125 South State Street, Room 6107, Salt Lake City, Utah, 84138; telephone 801-524-3715; facsimile 801-524-3858; e-mail at dkubly@uc.usbr.gov at least five (5) days prior to the call. Any written comments received will be provided to the AMWG members.

The Employment and Training Administration published a document in the Federal Register on April 22, 2008, announcing the availability of funds and solicitation for grant applications (SGA) for the Women in Apprenticeship and Nontraditional Occupations. This notice is an amendment to the SGA and it amends the ``Additional Award Administration Information'' and ``Other information'' sections.

The NPS is proposing to implement recent management decisions affecting Denali National Park and Preserve regarding backcountry management, climbing Mount McKinley, and off-road vehicle use for subsistence purposes.

The Alcohol and Tobacco Tax and Trade Bureau proposes to establish the 4,145-acre ``Snipes Mountain'' viticultural area in Yakima County, Washington. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. We invite comments on this proposed addition to our regulations.

We propose to revise the criteria in parts A and B of the Listing of Impairments (the listings) that we use to evaluate claims involving malignant neoplastic diseases. We apply these criteria when you claim benefits based on disability under title II and title XVI of the Social Security Act (the Act). The proposed revisions reflect our adjudicative experience, as well as advances in medical knowledge, treatment, and methods of evaluating malignant neoplastic diseases.

This notice is announcing that the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS), the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN), and the National Centers for Disease Control and Prevention (CDC), will co-sponsor a two-day summit that will include a public meeting on May 15, 2008, and an invitation-only simulation exercise on May 16, 2008. The purpose of the summit is to have a discussion with stakeholders on improved information sharing and coordination during multi-jurisdictional foodborne outbreak investigations.

The Food and Drug Administration (FDA) has determined that the 19 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's current good manufacturing practice (CGMPs) regulations for finished pharmaceuticals.

The Internal Revenue Service (IRS) requests applications of individuals to be considered for selection as Internal Revenue Service Advisory Council (IRSAC) members. Applications will be accepted for current vacancies and should describe and document the applicant's qualifications for membership. IRSAC is comprised of up to thirty (30) appointed members; approximately three of these appointments will expire in December 2008. It is important that the IRSAC continue to represent a diverse taxpayer and stakeholder base. Accordingly, to maintain membership diversity, selection is based on the applicant's qualifications as well as areas of expertise. The Internal Revenue Service Advisory Council (IRSAC) provides an organized public forum for IRS officials and representatives of the public to discuss relevant tax administration issues. The council advises the IRS on issues that have a substantive effect on federal tax administration. As an advisory body designed to focus on broad policy matters, the IRSAC reviews existing tax policy and/or recommends policies with respect to emerging tax administration issues. The IRSAC suggests operational improvements, offers constructive observations regarding current or proposed IRS policies, programs, and procedures, and advises the IRS with respect to issues having substantive effect on federal tax administration.