May 16, 2007 – Federal Register Recent Federal Regulation Documents

The Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that an Exempted Fishing Permit (EFP) application submitted by Dr. Pingguo He of the University of New Hampshire (UNH) contains all of the required information and warrants further consideration. The Assistant Regional Administrator has made a preliminary determination that the activities authorized under this EFP would be consistent with the goals and objectives of the Northeast (NE) Multispecies Fishery Management Plan (FMP). However, further review and consultation may be necessary before a final determination is made to issue an EFP. Therefore, NMFS announces that the Assistant Regional Administrator proposes to recommend that an EFP be issued that would allow one commercial fishing vessel to conduct fishing operations that are otherwise restricted by the regulations governing the fisheries of the Northeastern United States. The EFP would enable researchers to test an experimental whiting net that uses wheeled ground gear by granting exemption from the requirement to use a raised footrope trawl. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.

The SEDAR assessments of the South Atlantic stocks of greater amberjack and red snapper will consist of a series of three workshops: a Data Workshop, an Assessment Workshop, and a Review Workshop. This is the fifteenth SEDAR. See SUPPLEMENTARY INFORMATION.

This notice sets forth a revision of the terms and conditions that must be followed as a condition for access to the Automated Commercial Environment (ACE) Secure Data Portal (ACE Portal). These terms and conditions supersede and replace the Terms and Conditions documents previously signed and submitted to U.S. Customs and Border Protection (CBP) by ACE Portal Account Owners. The previous Terms and Conditions documents were not published in any public document but were provided to ACE Portal Account applicants after their acceptance into the test. For those ACE Portal Accounts already on file with CBP with the proper Account Owner listed, no further action is required by the ACE Portal Account Owner. The principal changes to the terms and conditions include a revised definition of ``Account Owner'' to permit either an individual or a legal entity to serve in this capacity, new requirements relating to providing notice to CBP when there has been a material change in the status of the Account and/or Account Owner, and explanatory provisions as to how the information from a particular account may be accessed through the ACE Portal when that account is transferred to a new owner. These terms and conditions do not affect participants in ACE who have not established Portal Accounts but who do participate via less formal Non-portal Accounts.

The Food and Drug Administration (FDA) has determined that MEPRON (atovaquone) tablets, 250 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atovaquone tablets, 250 mg.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications. Applicants are encouraged to use this guidance to design cancer clinical trials and to discuss protocols with the agency. This guidance provides background information and discusses general regulatory principles. Additional companion guidances will follow and will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. This guidance, and the subsequent indication-specific guidances, should speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims.

An open meeting of the Small Business/Self EmployedTaxpayer Burden Reduction Committee of the Taxpayer Advocacy Panel will be conducted in San Diego, California. The TAP will be discussing issues pertaining to increasing compliance and lessening the burden for Small Business/Self Employed individuals.

FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 26 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemptions will provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.

In this document, the Commission urges merchants to use caution in handling telephone orders for goods. The Commission has received informal complaints that people without disabilities, who are posing as deaf or hard of hearing consumers, are misusing an Internet base telecommunications relay service (``TRS'' or ``Relay Service'') called ``IP Relay'' to perpetrate fraudulent business transactions, often by using stolen or fake credit cards.

In this document, the Federal Communications Commission (FCC) adopts final rules governing wireless licenses in the 698-806 MHz Band (i.e., the 700 MHz Band). This spectrum is currently occupied by television broadcasters and is being made available for wireless services, including public safety and commercial services, as a result of the digital television (``DTV'') transition.

An Exposure Modeling Public Meeting (EMPM) will be held for one day on June 12, 2007. This notice announces the location and time for the meeting and sets forth the tentative agenda topics.

EPA has granted an experimental use permit (EUP) to the following pesticide applicant. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.