July 10, 2008 – Federal Register Recent Federal Regulation Documents

The Department of Commerce's International Trade Administration is seeking industry's involvement in providing information to inform the work program of the recently established Trilateral Committee on Transborder Data Flows under the Security and Prosperity Partnership of North America (SPP). In advance of its inaugural stakeholders' forum, tentatively scheduled for September 2008, the Committee is soliciting assistance in identifying and analyzing impediments to transborder data flows that impact on commercial activities. The Committee, composed of government representatives of each of the three countries, will work in consultation with the business community to identify and address impediments to electronic information flows across borders that impact economic growth. The Committee will also look at regulatory uncertainties related to the transborder flow of data and analyze the impact that they are having on the marketplace. The objective is to foster an integrated approach to information flows in North America while supporting regulatory cooperation to remove barriers to electronic information flows. Specifically, the Department is seeking: (1) A description of your company's activities. (2) How your company's activities involve cross-border data transfers and computerized information flows. (3) Impediments to cross-border data transfers and information flows. Impediments include legislative and regulatory requirements and other barriers. (4) Implications and costs for the company of these impediments (trade and investment). Business proprietary information should be marked accordingly. Once this process has been completed, the Committee will make recommendations to Ministers responsible for SPP on how to solve identified impediments to such information flows.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, has submitted the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.

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 National Marine Fisheries Service (NMFS) announces that the Office of Management and Budget (OMB) has approved the following collection of information pursuant to the Paperwork Reduction Act of 1995: OMB 0648-0546, ``Northeast Region Observer Providers Requirements.'' This rule publishes the OMB control number for these collections and makes effective the collection-of-information requirements published in a final rule to implement measures included in Framework Adjustment 19 (Framework 19) to the Atlantic Sea Scallop Fishery Management Plan (FMP).

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.

Notice is hereby given that the NMFS Pacific Islands Fisheries Science Center, Marine Mammal Research Program (MMRP) has been issued an amendment to scientific research and enhancement Permit No. 848-1695; and Dr. Teri Rowles, NMFS Marine Mammal Health and Stranding Response Program, has been issued an amendment to scientific research and enhancement Permit No. 932-1489.

We are adopting a new airworthiness directive (AD) for certain Cirrus Design Corporation (CDC) Models SR20 and SR22 airplanes. This AD requires you to replace the cabin door rod ends with new parts including a redesigned non-binding hinge pin that replaces the existing pin at the upper door hinge. This AD results from two known occurrences of in-flight cabin door separation (one total separation and one retained by the door strut). The rod ends, a component of the door hinges, may fail and result in a door separation from the airplane while in flight. We are issuing this AD to prevent in-flight failure of the cabin door, which could result in door separation from the airplane.

We, the U.S. Fish and Wildlife Service (Service/USFWS), under the authority of the Endangered Species Act of 1973, as amended (Act), amend the listing for the Preble's meadow jumping mouse (Zapus hudsonius preblei) (Prebles) to specify over what portion of its range the subspecies is threatened. Based on the best scientific and commercial data available, we have determined that the Prebles is a valid subspecies and should not be delisted based upon taxonomic revision; the subspecies is not threatened throughout all of its range; and the portion of the subspecies' current range located in Colorado represents a significant portion of the current range where the subspecies should retain its threatened status. This determination is based on a thorough review of all available information, which indicates that Prebles' populations in Wyoming are more widespread and threats to the subspecies less severe than those known at the time of listing, but that in Colorado the Prebles is likely to become endangered within the foreseeable future.

We are adopting a new airworthiness directive (AD) for the specified Bell Helicopter Textron Canada (BHTC) Model 206A, 206B, 206L, 206L-1, 206L-3, and 206L-4 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 which we have a bilateral agreement, states in the MCAI: ``It has been determined that some helicopters have been fitted with a CRES steel fitting, part number (P/N) 407-030-750-103, and the installation of the tailboom attachment bolt does not meet the design criteria.'' We are issuing this AD to require actions that are intended to address the unsafe condition that results from an improper installation of the tailboom attachment bolt in the upper left-hand tailboom attachment CRES steel fitting.

We are adopting a new airworthiness directive (AD) for Agusta S.p.A. Model AB 139 and AW 139 helicopters. This AD results from mandatory continuing airworthiness information (MCAI) issued by the European Aviation Safety Agency (EASA), the Technical Agent for Italy, with which we have a bilateral agreement, which indicates that the Agusta AB 139's and AW 139's Fuselage Frame 5700 middle section is prone to fatigue damage. The actions are intended to detect cracks in the fuselage frame structure and to prevent structural failure in this area.

This amendment adopts a new airworthiness directive (AD) for Bell Helicopter Textron Canada (BHTC) Model 222, 222B, 222U, 230 and 430 helicopters that requires rewiring and testing the fuel valve switch on each engine and testing the ignitor system. This amendment is prompted by an in-flight incident in which a fuel valve switch failed, causing the fuel valve to inadvertently close. The actions specified by this AD are intended to prevent interruption of the fuel supply caused by failure of the fuel switch, which could result in loss of engine power and subsequent loss of control of the helicopter.