December 4, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reclassification petitions for medical devices.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics,'' dated November 2008. The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under the U.S. Public Health Service Act (PHS Act). The guidance describes the licensing strategies for meeting the increased need for flexible manufacturing arrangements. The guidance announced in this notice finalizes the draft guidance of the same title.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Office of External Relations and WebMD, LLC. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls. Specific elements of the MOU include the creation of an FDA/WebMD online resource on the WebMD.com site, which will feature editorial and visual FDA Consumer Health Information, and the inclusion of FDA Consumer Health Information in at least three issues per year of WebMD The Magazine. An agency policy statement summarizing the criteria and processes for development of this type of collaboration is available on FDA's Web site at www.fda.gov/consumer/co_brandpolicy.html.

Applications are being sought for certain positions on the California Recreation Resource Advisory Committee. New members will be appointed by the Secretary of Agriculture and serve three-year terms. Appointments will begin July 2009 when current member appointments expire. One member is being sought to represent each of the following interests: (1) Winter Motorized Recreation, (2) Hunting and Fishing; and (3) Motorized Outfitting and Guiding or Local Environmental Groups. The public is invited to submit applications for these positions. Current members who have only served one term may reapply. Application packages can be obtained at https://www.fs.fed.us/passespermits/rrac- application.shtml or by e-mailing R5rrac@fs.fed.us. Interested parties may also contact Frances Enkoji, U.S. Forest Service, at 707-562-8846.

In April 2006 the Forest Service received a proposal from Western Pacific Timber LLC (WPT) in which a major exchange of land was proposed. The WPT proposal included approximately 40,000 acres of checkerboard land intermingled with the Clearwater National Forest near Powell, Idaho. These checkerboard lands are of interest to the Forest Service because they encompass the headwaters of the Lochsa River and hold outstanding values for many fish and wildlife species. The checkerboard lands also hold significant cultural resources including the Lewis and Clark National Historic Trail and Nez Perce Tribe treaty area. In September 2008 the Clearwater National Forest completed a feasibility analysis of the proposed exchange as a first level screen to review forest management plans, identify public benefit, identify availability of resources to complete the proposed exchange, identify title and property descriptions and identify potential support and opposition. The outcome of the feasibility analysis was a recommendation to enter into an Agreement to Initiate a land exchange with WPT. The agreement, signed by both parties in September, specifies the roles and responsibilities of each party involved in the exchange. In the proposed land exchange the Forest Service would acquire approximately 39,371 acres of land in the upper Lochsa River drainage in exchange for up to approximately 28,212 acres of National Forest System (NFS) land. It is anticipated that this is more than adequate federal acreage to complete an equal value land exchange. The NFS lands are located on the Clearwater, Nez Perce and Idaho Panhandle National Forests.

By letter dated June 12, 2008, Governor Timothy M. Kaine of Virginia requested that the U. S. Nuclear Regulatory Commission (NRC or Commission) enter into an Agreement with the Commonwealth of Virginia (Commonwealth or Virginia) as authorized by Section 274 of the Atomic Energy Act of 1954, as amended (Act). Under the proposed Agreement, the Commission would relinquish, and the Commonwealth would assume, portions of the Commission's regulatory authority exercised within the Commonwealth. As required by the Act, the NRC is publishing the proposed Agreement for public comment. The NRC is also publishing the summary of an assessment by the NRC staff of the Commonwealth's regulatory program. Comments are requested on the proposed Agreement, especially its effect on public health and safety. Comments are also requested on the NRC staff assessment, the adequacy of the Commonwealth's program, and the Commonwealth's program staff, as discussed in this notice. The proposed Agreement would release (exempt) persons who possess or use certain radioactive materials in the Commonwealth from portions of the Commission's regulatory authority. The Act requires that the NRC publish those exemptions. Notice is hereby given that the pertinent exemptions have been previously published in the Federal Register and are codified in the Commission's regulations as 10 CFR Part 150.

The USDA, Forest Service, Plumas National Forest will prepare a revised EIS on a proposal to harvest dead trees on approximately 10,366 acres within the Moonlight Fire and Antelope Complex (includes Wheeler Fire) perimeters. The proposal also includes harvesting dead and dying hazard trees on 4,389 acres along National Forest System (NFS) roads in the Moonlight Fire perimeter. The Moonlight Fire and Antelope Complex burned about 88,000 acres between July and September 2007 on the Plumas National Forest.

The FAA is adopting a new airworthiness directive (AD) for Pratt & Whitney (P&W) PW4052, PW4056, PW4060, PW4062, PW4152, PW4156A, PW4158, PW4460, and PW4462 turbofan engines. This AD requires a onetime visual inspection of all EEC-131 model electronic engine controls (EECs). This AD also requires the EECs to be identified, categorized by group number, marked, and replaced using a fleet management plan. This AD results from a report of an uncommanded engine in-flight shutdown due to defective EEC pulse width modulator (PWM) microcircuits. We are issuing this AD to prevent uncommanded in-flight engine shutdowns which could result in loss of thrust and prevent continued safe flight or landing.

We, the U.S. Fish and Wildlife Service (Service), are designating critical habitat for 12 species of Hawaiian picture-wing flies (Drosophila aglaia, D. differens, D. hemipeza, D. heteroneura, D. montgomeryi, D. mulli, D. musaphilia, D. neoclavisetae, D. obatai, D. ochrobasis, D. substenoptera, and D. tarphytrichia) under the Endangered Species Act of 1973, as amended (Act). In total, approximately 8,788 acres (ac) (3,556 hectares (ha)) fall within the boundaries of the final critical habitat designation. The critical habitat is located in four counties (City and County of Honolulu, Hawaii, Maui, and Kauai) in Hawaii.