May 2008 – Federal Register Recent Federal Regulation Documents

The Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that the subject exempted fishing permit (EFP) application, which would exempt Atlantic sea scallop (scallop) vessels participating in a modified scallop dredge twine top (twine top) study from minimum twine top mesh sizes, Closed Area I Access Area (CAI) and Closed Area II Access Area (CAII) closures, and fish possession restrictions, should be issued for public comment. The Assistant Regional Administrator has also made a preliminary determination that the activities authorized under the EFP would be consistent with the goals and objectives of the Atlantic Sea Scallop Fishery Management Plan (FMP). However, further review and consultation may be necessary before a final determination is made.

The USDA Forest Service is resuming preparation of the Shoshone National Forest revised land management plan as directed by the National Forest Management Act. Preparation of the revised plan was halted when the 2005 Forest Service planning rule was enjoined. A new planning rule (36 CFR part 219) was implemented on April 21 2008 allowing the planning process to be resumed. This notice resumes the plan revision process under the new planning rule.

The Bureau of Land Management (BLM), Alaska State Office, is issuing the Northeast National Petroleum ReserveAlaska (NPR-A) Supplemental Final Integrated Activity Plan/Environmental Impact Statement (IAP/EIS).

This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.

Subpart R of 42 CFR part 405 consists of regulations governing Medicare reimbursement determinations, and appeals of those determinations, by health care providers. (For the sake of simplicity, throughout this final rule, we use ``reimbursement'' to refer to Medicare payment under both the reasonable cost and prospective payment systems.) Under section 1878 of the Social Security Act (the Act) and the subpart R regulations, the Provider Reimbursement Review Board (the Board) has the authority to adjudicate certain substantial reimbursement disputes between providers and fiscal intermediaries (intermediaries). Board decisions are subject to review by the CMS Administrator, and the final agency decision of the Board or the Administrator, as applicable, is reviewable in Federal district court. In addition, under the subpart R regulations, intermediaries have the authority to hold hearings and adjudicate certain other payment and reimbursement disputes with providers. This final rule updates, clarifies, and revises various provisions of the regulations governing provider reimbursement determinations, appeals before the Board, appeals before the intermediaries (for lesser disputes), and Administrator review of decisions made by the Board.

In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

In this notice, we reapprove and grant AABB (formerly known as the American Association of Blood Banks) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) accreditation program and the Immunohematology Reference Laboratory (IRL) Program.

The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. State and local government agencies apply for certification of substantial equivalency with the Fair Housing Act. Once determined to be substantially equivalent, HUD enters into a cooperative agreement with such an agency though which funding is provided in support of fair housing enforcement.

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the objects to be included in the exhibition ``Women Impressionists: Berthe Morisot, Mary Cassatt, Eva Gonzales, Marie Bracquemond'', imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Fine Arts Museums of San Francisco, de Young Legion of Honor, San Francisco, California, from on or about June 21, 2008, until on or about September 21, 2008, and at possible additional exhibitions or venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the U.S. Army Corps of Engineers, Mobile District. This MOU establishes a mutual framework governing the respective responsibilities of the parties for the provision of health services through the Corps' Regional Occupational Health Center to FDA employees at the FDA Gulf Coast Seafood Laboratory. Goods and services the Corps may provide include, but are not limited to, physicals at age-appropriate intervals, referral of employees to private physicians, prevention programs related to health, and other related goods and services as meet the criteria and standards of the Public Health Service, immunizations for influenza and tetanus, and safety and environmental counseling

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products'' dated May 2008. The draft guidance document is intended to provide recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus. The draft guidance is intended to provide assistance by identifying the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA).

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of food industry supervisory employees about their awareness and perceptions of FDA's Food Defense Awareness Initiative ALERT.