July 10, 2008 – Federal Register Recent Federal Regulation Documents

The Department of Commerce (``the Department'') publishes this final rule to adopt, without change, an interim final rule that implemented tariff rate quotas (``TRQ'') for a limited quantity of certain cotton shirting fabrics pursuant to Section 406 of the Tax Relief and Health Care Act of 2006 (``the Act''), which President Bush signed into law on December 20, 2006 (Pub. L. 109-432). Section 406(b)(1) of the Act authorizes the Secretary of Commerce to issue licenses to eligible manufacturers under headings 9902.52.08 through 9902.52.19 of the Harmonized Tariff Schedule of the United States, specifying the restrictions under each such license on the quantity of cotton woven fabrics that may be entered each year by or on behalf of the manufacturer.

This document contains proposed regulations under sections 401(a)(9) and 403(b) of the Internal Revenue Code (Code) to permit a governmental plan to comply with the required minimum distribution rules by using a reasonable and good faith interpretation of the statute. These proposed regulations will affect administrators of, employers maintaining, participants in, and beneficiaries of governmental plans.

The Office of Justice Programs of the U.S. Department of Justice proposes this rule to amend the regulation that implements the Public Safety Officers' Benefits Act and associated or related statutes. Generally speaking, these laws provide financial support to certain public safety officers, or their survivors and families, when such officers die, or become permanently and totally disabled, as a result of line-of-duty injuries, or when they die of heart attacks or strokes sustained within statutorily-specified timeframes of engaging or participating in certain line-of-duty activity. The proposed rule would amend the implementing regulation to reflect internal agency policy and practice, recent statutory enactments and court decisions, and to make certain technical changes, in order to keep the regulations comprehensive and current.

NMFS announces the suspension of the primary season forPacific whiting (whiting) fishery for the shore-based sector south of 42[deg] N. lat. at noon local time (l.t.) May 21, 2008. ``Per trip'' limits for whiting were reinstated until 0001 hours June 15, 2008, at which time the primary season for the shore-based sector opened coastwide. This action is authorized by regulations implementing the Pacific Coast Groundfish Fishery Management Plan (FMP), which governs the groundfish fishery off Washington, Oregon, and California. This action is intended to keep the harvest of whiting at the 2008 allocation levels.

The Drug Enforcement Administration (DEA) is finalizing, without change, the Interim Rule with Request for Comment published in the Federal Register on July 25, 2007 (72 FR 40738). The Interim Rule removed the Controlled Substances Act (CSA) exemptions for chemical mixtures containing ephedrine and/or pseudoephedrine with concentration limits at or below five percent. Upon the effective date of the Interim Rule, all ephedrine and pseudoephedrine chemical mixtures, regardless of concentration and form, became subject to the regulatory provisions of the CSA. DEA regulated the importation, exportation, manufacture, and distribution of these chemical mixtures by requiring persons who handle these chemical mixtures to register with DEA, maintain certain records common to business practice, and file certain reports, regarding these chemical mixtures. No comments to the Interim Rule were received. This Final Rule finalizes the Interim Rule without change.

NMFS is proposing to implement a new management measure for the monkfish fishery recommended in Framework Adjustment 6 (Framework 6) to the Monkfish Fishery Management Plan (FMP), which has been submitted jointly by the New England and Mid-Atlantic Fishery Management Councils (Councils). This action would eliminate the backstop provision adopted in Framework Adjustment 4 (Framework 4) to the FMP, which was implemented in October 2007. This provision would have adjusted, and possibly closed, the directed monkfish fishery in fishing year (FY) 2009 if the landings in FY 2007 exceeded the target total allowable catch (TTAC). Given the most recent information on the status of monkfish stocks, the backstop provision is no longer deemed necessary.

The Food and Drug Administration (FDA) is amending its regulations on new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for approval to market new drugs and generic drugs (drugs for which approval is sought in an ANDA). The final rule discontinues FDA's use of approvable letters and not approvable letters when taking action on marketing applications. Instead, we will send applicants a complete response letter to indicate that the review cycle for an application is complete and that the application is not ready for approval. We are also revising the regulations on extending the review cycle due to the submission of an amendment to an unapproved application and starting a new review cycle after the resubmission of an application following receipt of a complete response letter. In addition, we are adding to the regulations on biologics license applications (BLAs) provisions on the issuance of complete response letters to BLA applicants. We are taking these actions to implement the user fee performance goals referenced in the Prescription Drug User Fee Amendments of 2002 (PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

We are adopting a new airworthiness directive (AD) for all Boeing Model 747 airplanes listed above. This AD requires repetitive inspections for broken or missing fasteners in the single-row hinge fasteners of the forward and aft cargo doors, and related investigative/corrective actions. This AD results from reports of broken and missing fasteners in the hinges of the forward and aft cargo doors in both the body hinge segments and the door hinge segments. We are issuing this AD to detect and correct broken or missing fasteners in the hinge segments with a single fastener row, which could lead to opening of the cargo door during flight and result in rapid decompression of the airplane.

The FAA is superseding an existing airworthiness directive (AD) for certain fuel injected reciprocating engines manufactured by Lycoming Engines. That AD currently requires inspection, and replacement if necessary, of externally mounted fuel injector fuel lines. This AD requires the same actions but adds additional engine models and clarifies certain compliance time wording. This AD also exempts engines that have a Maintenance and Overhaul Manual with an Airworthiness Limitations Section that requires inspection and replacement, if necessary, of externally mounted fuel injector lines. This AD results from Lycoming Engines revising their Mandatory Service Bulletin to add new engine models requiring inspection, and from the need to clarify a repetitive inspection compliance time. We are issuing this AD to prevent failure of the fuel injector fuel lines that would allow fuel to spray into the engine compartment, resulting in an engine fire.

We are adopting a new airworthiness directive (AD) for the specified Bell Helicopter Textron Canada (BHTC) helicopters. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority to identify and correct an unsafe condition on an aviation product. The Aviation Authority of Canada with whom we have a bilateral agreement states in the MCAI: ``Horizontal stabilizers part numbers 206-023-119-167 and 407-023-801-109 may have manufacturing flaws on the inside surface of the upper and/or lower skin at the tailboom attachment inserts. These flaws may result in cracking of the skin and failure of the horizontal stabilizer.'' The manufacturer's service information states that in addition to cracks, the horizontal stabilizer may have deformation or debonding around and between the inserts. We are issuing this AD to require actions to correct the unsafe condition on these products.

NMFS is prohibiting directed fishing for northern rockfish in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2008 total allowable catch (TAC) of northern rockfish in the Western Regulatory Area of the GOA.