October 18, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

On August 9, 2007, FRA published a direct final rule in the Federal Register which made technical amendments to Appendix D of 49 CFR Part 222. As reflected in DOT Docket No. FRA-2007-27285, FRA did not receive any comments or requests for an oral hearing on the direct final rule. Therefore, FRA is issuing this document to confirm that the direct final rule took effect on October 9, 2007, the date specified in the rule.

The Coast Guard is removing the existing drawbridge operation regulation for the draw of the U.S. 165 bridge, mile 110.1, on the Ouachita River at Columbia, Louisiana. The drawbridge has been removed from the waterway. Therefore, the regulation controlling the operation of the drawbridge is no longer necessary.

EPA is approving a Section 111(d) Plan revision submitted by the Commonwealth of Virginia. The revision consists of amendments to the regulation that controls total reduced sulfur (TRS) from pulp and paper mills. This action is being taken under the Clean Air Act (CAA).

The EPA is announcing an extension of the public comment period on our proposed amendments for the Operating Permit Programs and Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Flexible Air Permitting Rule; Proposed Rule (September 12, 2007). The EPA is extending the comment period that originally ends on November 13, 2007. The extended comment period will close on January 14, 2008. The EPA is extending the comment period because of the timely requests we received to do so.

DOE published in the Federal Register, Tuesday, October 9, 2007, a notice Energy Efficiency for Certain Commercial and Industrial Equipment: Public Meeting and Availability of the Framework Document for Residential Clothes Dryers and Room Air Conditioners. In that notice, there was an error in the date for accepting comments.

Pension Benefit Guaranty Corporation (PBGC) proposes amending its regulation on Administrative Review of Agency Decisions (29 CFR part 4003) to clarify that the agency's Appeals Board may refer certain categories of appeals to other PBGC departments for a written response and to remove determinations under section 4022A of the Employee Retirement Income Security Act of 1974 (ERISA) from the scope of part 4003. The proposed amendments also include minor clarifying and technical changes to the rules for administrative review of agency decisions.

The Food and Drug Administration (FDA) is amending its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The changes apply to drug products that are life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product. The final rule implements provisions of the Modernization Act by requiring an applicant who is the sole manufacturer of one of these products to notify FDA at least 6 months before discontinuing manufacture of the drug product.

EPA is proposing to approve a revision to the Kansas City and St. Louis portions of the Missouri State Implementation Plan (SIP) to amend the transportation conformity criteria and procedures related to interagency consultation and enforceability of certain transportation- related control measures and mitigation measures.

The Department of Defense proposes to revise and update policy guidance and oversight of the Military Service Academies. This proposed rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy.

NMFS is prohibiting directed fishing for groundfish by vessels using trawl gear in the Gulf of Alaska (GOA), except for directed fishing for pollock by vessels using pelagic trawl gear in those portions of the GOA open to directed fishing for pollock. This closure also does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Pilot Program for the Central GOA. This action is necessary to prevent exceeding the 2007 Pacific halibut prohibited species catch (PSC) limit specified for trawl gear in the GOA.

The U.S. Fish and Wildlife Service (Service or we) adds all forms of live black carp (Mylopharyngodon piceus), gametes, viable eggs, and hybrids to the list of injurious fish under the Lacey Act. By this action, the Service prohibits the importation into or transportation between the continental United States, the District of Columbia, Hawaii, the Commonwealth of Puerto Rico, or any territory or possession of the United States of live black carp, gametes, viable eggs, and hybrids. The best available information indicates that this action is necessary to protect the interests of wildlife and wildlife resources from the purposeful or accidental introduction and subsequent establishment of black carp in the ecosystems of the United States. Live black carp, gametes, viable eggs, and hybrids can be imported only by permit for scientific, medical, educational, or zoological purposes, or without a permit by Federal agencies solely for their own use. Interstate transportation of live black carp, gametes, viable eggs, and hybrids currently held within the United States will be allowed only by permit. Interstate transportation permits may be issued for scientific, medical, educational, or zoological purposes.

NMFS is prohibiting directed fishing for the 2007 Pacific cod sideboard limits apportioned to non-American Fisheries Act (AFA) crab vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2007 Pacific cod sideboard limits apportioned to non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the GOA.