2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. This will be a 1-day workshop involving FDA staff and representatives from businesses currently marketing unapproved drugs. The purpose of the workshop is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the new drug application (NDA) and abbreviated new drug application (ANDA) processes and how to legally market drugs through compliance with the over-the-counter (OTC) monographs.

The Commission will consider a Report and Order regarding changes to the process for community of license changes and the process for amendments to the FM Table of Allotments. 2 Wireless Title: In the Matter of the Effects of Telecommunications. Communications Towers on Migratory Birds (WT Docket No. 03-187). Summary: The Commission will consider a Notice of Proposed Rulemaking on whether it should adopt certain measures to mitigate migratory bird collisions with communications towers. 3 Wireline Competition. Title: United Power Line Council's Petition for Declaratory Ruling Regarding the Classification of Broadband over Power Line Internet Access Service as an Information Service (WC Docket No. 06-10). Summary: The Commission will consider a Memorandum Opinion and Order concerning the classification of broadband over power line Internet access service. 4 Wireline Competition. Title: AT&T Inc. and BellSouth Corporation Application for Transfer of Control (WC Docket No. 06-74).

This Notice announces that the Transportation Security Administration (TSA) has forwarded the new Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for emergency processing and approval under the Paperwork Reduction Act. The ICR describes the nature of information collection and its expected burden.

This action extends the comment period for 12 days on an October 5, 2006, proposed rule regarding the first 2007 fishing season for Atlantic sharks. Due to late dealer reports that may substantially change landings estimates of large and small coastal sharks during the first trimester of 2006 for the Gulf of Mexico, NMFS is extending the comment deadline on that proposed rule from November 1, 2006, until November 13, 2006.

Congress, in the Interior Appropriations Act of 2000, authorized the Fort King Special Resource Study and Final Environmental Impact Statement (``Study''). The legislation directed the National Park Service (NPS) to determine whether Fort King is nationally significant and, if so, whether it is suitable and feasible as a new unit of the National Park System. Acknowledging the site's National Historic Landmark (NHL) status, the Study determined that Fort King is nationally significant. In addition, the Study determined that Fort King is suitable and feasible for inclusion in the National Park System because its interpretive themes are underrepresented in the current system and the property is of sufficient size and shape to protect resources and accommodate public use. The study does not, however, propose an active NPS management role at the site. Rather, existing programs such as Save America's Treasures and Preserve America are used to exemplify the types of NPS assistance available to future non- Federal managers of the Fort King property. The Final Study was distributed for public review in August 2006. The NPS has prepared a Record of Decision (ROD) on the Study to document the decision made, the background of the project, other alternatives considered, the basis for the decision, the environmentally preferable alternative, and the public involvement in the decision-making process. The 1998 Omnibus Parks Management Act (Pub. L. 105-391 Sec. 303) mandates that each Special Resources Study (SRS) identify the alternative or combination of alternatives which would, in the professional judgment of the Director of the NPS, be ``most effective and efficient in protecting significant resources and providing for public enjoyment.'' The Study identifies Alternative B in the Study as the environmentally preferred alternative and most effective and efficient alternative because it preserves more of the site's archeological resources in an undisturbed condition and minimizes capital expenditures and long-term operating costs. Under Alternative B, the historic significance of Fort King would be communicated to visitors primarily through self-guided interpretive trails, wayside exhibits, and brochures. The park would not have a permanent on-site staff. Guided tours and live interpretation programs for school groups and special events would be provided by volunteers on a case by case basis. The site's existing wooded landscape would remain predominantly unchanged. Pedestrian trails would be cleared by vegetation and lightly graded. Trees and other woody vegetation immediately surrounding the fort location would be thinned or removed for interpretive purposes. The Federal government would not assume ownership of land, impose zoning or land use controls, or take responsibility for permanent funding. Likewise, there would be no direct NPS ownership or management of resources. As with other National Historic Landmarks, the NPS could provide technical assistance for general planning, resource management, and interpretation. However, overall management of the Fort King site would be administered by one or more local entities. The Study also presented in detail a No Action and two Action Alternatives that describe different ways of commemorating, interpreting, and preserving resources associated with Fort King. All alternatives are described in detail in the Study. Alternative B provides a broad range of public benefits such as improved public access, long-term preservation of archeological resources, and increased visitor awareness of the site's national significance while minimizing capital expenditures and long-term operating costs.

This notice announces the following proposed changes to Rules 9(e), 14, 19(a)(5), 19(b)(3), 19(g), 22(b)(3), 26(b), 37(c)(1), and 41(a) of the Rules of Practice and Procedure, United States Court of Appeals for the Armed Forces for public notice and comment. New language is in bold print. Language to be deleted is marked by a strikethrough.

Under the provisions of the Paperwork ReductionAct of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation(FAR) Secretariat will be submitting to the Office of Management and Budget(OMB) a request to review and approve an extension of a currently approvedinformation collection requirement concerning Defense Production ActAmendments. A request for public comments was published in the Federal Register at 71 FR 38866, July 10, 2006. No commentswere received. The clearancecurrently expires on October 31, 2006. Public comments are particularly invited on: Whether this collection ofinformation is necessary for the proper performance of functions of theFAR, and whether it will have practical utility; whether our estimate ofthe public burden of this collection of information is accurate, and basedon valid assumptions and methodology; ways to enhance the quality, utility,and clarity of the information to be collected; and ways in which we canminimize the burden of the collection of information on those who are torespond, through the use of appropriate technological collection techniquesor other forms of information technology.

The Federal Energy Regulatory Commission (Commission) is amending its regulations governing small power production and cogeneration in response to section 1253 of the Energy Policy Act of 2005 (EPAct 2005), which added section 210(m) to the Public Utility Regulatory Policies Act of 1978 (PURPA).

The Food and Drug Administration (FDA) is proposing to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed changes to the National Drug Code (NDC) system contained in the agency's proposed rule governing drug establishment registration and drug listing. The proposed rule appeared in the Federal Register of August 29, 2006 (71 FR 51276). In addition, in response to requests for an extension, FDA is extending to January 26, 2007, the comment period for the proposed rule to provide interested parties additional time to submit comments.

This notice is to inform the public of the availability of eight-month 2006 import statistics relating to competitive need limitations (CNLs) under the Generalized System of Preferences (GSP) program. The eight-month 2006 import statistics identify those articles for which the 2006 trade levels may exceed statutory CNLs. The interim trade data is available at: https://www.ustr.gov/TradeDevelopment/ PreferencePrograms/GSP/SectionIndex.html. As previously announced in the Federal Register (71 FR 37129 (June 29, 2006)), the deadline for submission of product petitions to waive the CNLs for individual beneficiary developing countries with respect to GSP-eligible articles is 5 p.m., November 17, 2006. Petitions must conform to the requirements as set forth in the June 29, 2006 Federal Register notice. Public comments regarding possible de minimis waivers and possible GSP redesignations will be requested in a subsequent Federal Register notice.

This is a notice of an Administrative declaration of a disaster for the State of FLORIDA dated 10/25/2006. Incident: Flea Market Fire. Incident Period: 09/25/2006. Effective Date: 10/25/2006. Physical Loan Application Deadline Date: 12/26/2006. Economic Injury (EIDL) Loan Application Deadline Date: 07/25/2007.

This is a Notice of the Presidential declaration of a major disaster for the State of New York (FEMA-1665-DR), dated October 24, 2006.. Incident: Severe Storms and Flooding. Incident Period: October 12, 2006 and continuing. Effective Date: October 24, 2006. Physical Loan Application Deadline Date: December 26, 2006. Economic Injury (EIDL) Loan Application Deadline Date: July 24, 2007.

In accordance with the Comprehensive Environmental Response Compensation, and Liability Act of 1980, as amended, 42 U.S.C. 9601 et seq. (``CERCLA''), notice is hereby given of the proposed Agreement between the U.S. Environmental Protection Agency (``EPA'') and DV Luxury Resort, LLC. (``Settling Respondent''). The proposed Agreement relates to Settling Respondent's plan to build a resort hotel and condominium project at the Empire Canyon Site located in Park City, Summit County, Utah (the ``Site''). Settling Respondent is not a Potentially Responsible Party at the Site. Settling Respondent proposes to lease the Site from United Park City Mines, a Potentially Responsible Party that in 2003 entered into an Administrative Order on Consent with EPA for cleaning up historic mine waste at the Site. Pursuant to the proposed Agreement, the Settling Respondent would undertake additional cleanup at the Site appropriate so that the Site may be used for recreational purposes. The Settling Respondent has agreed to pay $38,000 to EPA in exchange for a covenant by EPA not to sue the Settling Respondent for certain response costs that may result from transporting mine wastes to the Richardson Flat Site for disposal. These funds will be deposited into the Special Account for the Richardson Flat Site. The Settling Respondent also agrees to pay EPA's oversight costs under this Agreement.

NMFS publishes Fraser River salmon inseason orders to regulate salmon fisheries in U.S. waters. The orders were issued by the Fraser River Panel (Panel) of the Pacific Salmon Commission (Commission) and subsequently approved and issued by NMFS during the 2006 salmon fisheries within the U.S. Fraser River Panel Area. These orders established fishing dates, times, and areas for the gear types of U.S. treaty Indian and all citizen fisheries during the period the Panel exercised jurisdiction over these fisheries.

This is a notice of an Administrative declaration of a disaster for the Commonwealth of Kentucky dated October 25, 2006. Incident: Severe Storms and Flooding. Incident Period: September 22, 2006 through September 29, 2006. Effective Date: October 25, 2006. Physical Loan Application Deadline Date: December 26, 2006. Economic Injury (EIDL) Loan Application Deadline Date: July 25, 2007.