Department of Health and Human Services September 2008 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Establishing Benchmarks for the Medical Office Survey on Patient Safety.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

This interim final rule with comment period (IFC) revises the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans. This IFC makes conforming changes to the MA regulations to reflect new statutory requirements regarding special needs plans (SNP), private- fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, Medicare medical savings accounts (MSA) plans, and new statutory provisions governing cost-sharing for dual-eligible enrollees in the MA program prescription drug pricing, coverage, and payment processes in the Part D program. In addition, this IFC sets forth new requirements governing the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. Both the conforming changes to the regulations to reflect new statutory provisions and the new marketing requirements are based on provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008.

The Health Resources and Services Administration (HRSA) will be providing temporary critical HIV medical care and treatment services through GLH Magnolia Medical Clinic to avoid a disruption of HIV clinical care to clients in Bolivar, Sunflower and Washington counties in Mississippi.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Animal Health Pharmaceuticals, LLC. The supplemental NADA provides for a revised human food safety warning on labeling for an oral suspension of sulfadiazine and pyrimethamine used for the treatment of equine protozoal myeloencephalitis (EPM).

The Food and Drug Administration (FDA) is proposing to amend its bottled water regulations to require that source water, which is currently subject to weekly microbiological testing, be tested specifically for total coliform as is done for finished bottled water products. Further, FDA is proposing that if any coliform organisms are detected in source water or finished bottled water products, bottled water manufacturers would be required to test for the bacterium Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is proposing to amend the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli would be considered adulterated, and source water containing E. coli would not be considered to be of a safe, sanitary quality and would be prohibited from use in the production of bottled water. In addition, this rule would require bottlers to rectify or eliminate the source of E. coli contamination in source water and keep records of such actions. Existing regulatory provisions would require bottled water manufacturers to keep records of new testing required by this rule. FDA tentatively concludes that this proposed rule, if finalized, will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.

In FY 2006, ORR awarded a competitive Services for Survivors of Torture grant to the Center for Multicultural Human Services (CMHS) in Falls Church, Virginia. The original project period was from September 30, 2006 through September 29, 2009. CMHS served as fiscal sponsor and legal entity of the approved project. As of March 31, 2008, CMHS ceased operations. CMHS has requested permission for Northern Virginia Family Service to assume the grant. Northern Virginia has agreed to this request. The effect of this deviation request is to transfer the grant from the initial grantee to a new grantee with the scope and operations of the grant remaining unchanged.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Brussels, Belgium'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Brussels, Belgium. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, November 10 to 13, 2008, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Tuesday, October 21, 2008, from 3 p.m. to 5:30 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Conference Rooms D and E, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 2:45 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Rooms D and E. Contact Person: All participants must register with Tammie Jo Bell, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by email: tammie.bell@fda.hhs.gov or fax: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentation, to the contact person by October 14, 2008. If you need special accommodations due to a disability, please contact Tammie Jo Bell at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-66, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. Background: The ICH was established in 1990 as a joint regulatory/ industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States, without compromising the regulatory obligations of safety and effectiveness. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. ICH is concerned with harmonization among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor and Welfare; the Japanese Pharmaceutical Manufactures Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and Health Canada, the European Free Trade Area and the World Health Organization. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the three ICH regions. The current ICH process and structure can be found at the following Web site: https://www.ich.org.

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the U.S. Department of Health and Human Services is hereby announcing renewal of the charter for the Chronic Fatigue Syndrome Advisory Committee (CFSAC).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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 Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 for user fees under the Animal Drug User Fee Act program (ADUFA). The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA I), and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2009. For FY 2009, the animal drug user fee rates are: $246,300 for an animal drug application; $123,150 for a supplemental animal drug application for which safety or effectiveness data is required and for an animal drug application subject to certain criteria; $4,925 for an annual product fee; $59,450 for an annual establishment fee; and $52,700 for an annual sponsor fee. FDA will issue invoices for FY 2009 product, establishment, and sponsor fees by December 31, 2008, and these invoices will be due and payable on or before January 31, 2009. FDA will issue invoices in November 2009 for any products, establishments, and sponsors that are subject to fees for FY 2009 but that qualified for fees after the December 2008 billing. The application fee rates are effective for applications submitted on or after October 1, 2008, and will remain in effect through September 30, 2009. Applications will not be accepted for review until FDA has received full payment of application fees and any other animal drug user fees owed.

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.