September 16, 2008 – Federal Register Recent Federal Regulation Documents

In a Federal Register notice published on August 19, 2008, the Federal Trade Commission (``Commission'' or ``FTC'') requested comment on its Notice of Proposed Rulemaking (``NPRM'') in connection with its rulemaking pursuant to Section 811 of the Energy Independence and Security Act of 2007 (``EISA''). The NPRM stated that comments must be received on or before September 18, 2008. In response to a request to extend the comment period received on September 5, 2008, the Commission has determined to extend the comment period until October 17, 2008.

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 following information collections, as required by the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA 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.

Through this notice, the Federal Transit Administration (FTA) clarifies its policy with respect to its interpretation of ``tripper service'' and ``school bus operations'' under 49 CFR part 605.

NMFS has received a request from the U.S. Navy (Navy) for authorization for the take of marine mammals incidental to vehicle launches from San Nicolas Island (SNI), California, for the period 2009 2014. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the Navy's request for the development and implementation of regulations governing the incidental taking of marine mammals and inviting information, suggestions, and comments on the Navy's application and request.

NMFS will hold a 3-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in September and October 2008. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public. A public hearing and scoping meetings will be held in conjunction with the AP meeting.

The U.S. Environmental Protection Agency's (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and ethical review of human subjects research.

Notice is hereby given that the U.S. International Trade Commission has issued a limited exclusion order against infringing products of Shanghai Kingtainer Packaging Container Co., Ltd., which was previously found in default, and has terminated the above-captioned investigation under section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337).

The Food Safety and Inspection Service (FSIS) is announcing that, since January 28, 2008, its laboratories have implemented a revised laboratory methodology for detecting and identifying E. coli O157:H7 in regulatory verification samples. This new method can be found in the Microbiology Laboratory Guidebook (MLG), Chapter 5.04.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Brussels, Belgium'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Brussels, Belgium. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, November 10 to 13, 2008, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Tuesday, October 21, 2008, from 3 p.m. to 5:30 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Conference Rooms D and E, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 2:45 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Rooms D and E. Contact Person: All participants must register with Tammie Jo Bell, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by email: tammie.bell@fda.hhs.gov or fax: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentation, to the contact person by October 14, 2008. If you need special accommodations due to a disability, please contact Tammie Jo Bell at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-66, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. Background: The ICH was established in 1990 as a joint regulatory/ industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States, without compromising the regulatory obligations of safety and effectiveness. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. ICH is concerned with harmonization among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor and Welfare; the Japanese Pharmaceutical Manufactures Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and Health Canada, the European Free Trade Area and the World Health Organization. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the three ICH regions. The current ICH process and structure can be found at the following Web site: https://www.ich.org.