July 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the re- establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.

The National Nuclear Security Administration (NNSA), a separately organized semi-autonomous agency within the U.S. Department of Energy (DOE), announces the availability of the Draft Site-Wide Environmental Impact Statement for the Continued Operation of the Department of Energy/National Nuclear Security Administration Nevada National Security Site and Off-Site Locations in the State of Nevada (Draft SWEIS, DOE/EIS-0426D) for public review, as well as the locations, dates and times for public hearings. The Draft SWEIS for the continued management and operation of the Nevada National Security Site (NNSS) (formerly known as the Nevada Test Site) and other NNSA-managed sites in Nevada, including the Remote Sensing Laboratory (RSL) on Nellis Air Force Base, the North Las Vegas Facility (NLVF), and the Tonopah Test Range (TTR) on the U.S. Air Force Nevada Test and Training Range, analyzes the potential environmental impacts for three alternatives: No Action Alternative, Expanded Operations Alternative and Reduced Operations Alternative. Each alternative comprises current and reasonably foreseeable activities at the NNSS and the three offsite locations. The Council on Environmental Quality's (CEQ) National Environmental Policy Act (NEPA) implementing regulations allow an agency to identify its preferred alternative or alternatives, if one or more exists, in a draft EIS (40 CFR 1502.14[e]). NNSA has not currently identified a preferred alternative; however, a preferred alternative will be identified in the Final SWEIS. The U.S. Air Force, U.S. Bureau of Land Management, and Nye County, Nevada, are cooperating agencies in the preparation of this Draft SWEIS. In addition, the Consolidated Group of Tribes and Organizations, which include representatives from 17 Tribes and organizations, participated in its preparation.

This notice announces a forthcoming meeting of a public advisory committee of the Office of Advocacy and Outreach (OAO). Notice of the meetings are provided in accordance with section 10(a)(2) of the Federal Advisory Committee Act, as amended, (5 U.S.C. Appendix 2). This meeting will be open to the public. As required by the Federal Advisory Committee Act, as amended, the OAO announces a public meeting of the Advisory Committee on Minority Farmers (Committee) to advise the Secretary of Agriculture on: (1) The implementation of section 2501 of the Food, Agriculture, Conservation, and Trade Act of 1990, as amended, 7 U.S.C. 2279; (2) methods of maximizing the participation of minority farmers and ranchers in Department of Agriculture programs; and (3) civil rights activities within the Department as such activities relate to participants in such programs.

The Food and Drug Administration (FDA) is announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer-reported outcome (ObsRO) measures. This public workshop is intended to provide information for and gain perspectives from patient advocates, health care providers, researchers, regulators, individuals from academia, industry, and other interested persons on various aspects of the development and implementation of COAs in the evaluation of treatment benefit. Regulatory review issues regarding context of use and documentation of the measurement properties of a COA will be covered during panel discussions. The input from this public workshop will be published in the form of a white paper or a series of manuscripts.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Department of Commerce (``the Department'') has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with June anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews. The Department received requests to revoke two antidumping duty orders in part and to defer the initiation of an administrative review for two antidumping duty orders.

HUD is moving its regulation implementing the governmentwide common rule on drug-free workplace requirements for financial assistance from one title in the Code of Federal Regulations (CFR) to another title. This relocation of the requirements from one CFR title to another responds to directions from the Office of Management and Budget (OMB) to all federal agencies to consolidate into one CFR title all federal regulations on drug-free workplace requirements for financial assistance. These changes constitute an administrative simplification and make no substantive change in HUD policy or procedures for drug-free workplace.

Amendment 93 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) would amend the Bering Sea and Aleutian Islands Amendment 80 Program to modify the criteria for forming and participating in a harvesting cooperative. This action is necessary to encourage greater participation in harvesting cooperatives, which enable members to more efficiently target species, avoid areas with undesirable bycatch, and improve the quality of products produced. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Fishery Management Plan, and other applicable law.

Notice is hereby given that David Honig, Nicholas School of the Environment, Duke University Marine Laboratory, 135 Marine Lab Road, Beaufort, NC 28516, has applied in due form for a permit to collect, receive, import, export, possess, and conduct analyses marine mammal specimens for scientific research.

Notice is hereby given that Florida Fish and Wildlife Conservation Commission, 100 Eighth Avenue, SE, St. Petersburg, FL 33701 [Gregg Poulakis, Responsible Party], has applied in due form for a permit to take smalltooth sawfish and listed sea turtle species for purposes of scientific research.

In accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) invites the general public and Federal agencies to comment on the renewal without change of the Standard Form 425, Federal Financial Report and the SF-425A, Federal Financial Report Attachment. Both forms are used in reporting financial information under grants and cooperative agreements.

In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department for funding under the FY 2010 HUD-VASH program. This announcement contains the consolidated names and addresses of those award recipients selected for funding under the Omnibus Appropriations Act, 2010.

The Food and Drug Administration (FDA) has conducted a reorganization to modify its structure, to align similar functions under common executive leadership, and to reduce and change the reporting relationships to the Agency head. The reorganization creates four ``directorates'' within which most of FDA's activities will resideAdministrative operations, food and veterinary medicine, medical products and tobacco, and foreign and domestic regulatory operations. However, this restructuring will not change the basic form of FDA's programs, which will continue to reside in the Agency's seven operating Centers and the Office of Regulatory Affairs. It is intended to provide a more efficient span of control for executive leadership and to organize like activities together, not to change the essential programmatic activities under which FDA implements the Federal Food, Drug, and Cosmetic Act.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled In Re Certain Computer Forensic Devices and Products Containing the Same, DN 2834; the Commission is soliciting comments on any public interest issues raised by the complaint.

The Food and Drug Administration (FDA) is considering factors affecting the reprocessing of reusable medical devices, including reprocessing quality, device design as it relates to the reprocessing of reusable medical devices, reprocessing methodologies, validation methodologies, and health care facility best practices. This is part of an ongoing effort to address patient exposure to inadequately reprocessed reusable medical devices. FDA would like to provide another opportunity for public comment by establishing a docket to receive information and comments from the public on factors affecting the reprocessing of reusable medical devices.