Department of Health and Human Services March 2006 – Federal Register Recent Federal Regulation Documents

Federal Register Notice (volume 71, number 14, pp 3519-3520) published on January 23, 2006, inadvertently omitted information on the review and access of the material received in response to the solicitation of comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies. Docket: For access to the docket to read background documents or comments received, go to the Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857 weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m. To schedule an appointment to view public comments, phone (301) 443- 7757.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Using a Centralized IRB Process in Multicenter Clinical Trials.'' The guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of FDA regulations by facilitating the use of a centralized IRB review process.

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 amending the animal drug regulations to reflect a change of drug labeler code for Med- Pharmex, Inc.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Safety Evaluation of Drug or Biologic Combinations.'' This guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), co-packaged products, and some adjunctive therapies.

The Food and Drug Administration (FDA) has determined the regulatory review period for RELPAX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for CRESTOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse, and substance-related problems among all individuals, including youth. As part of this effort, SAMHSA has expanded and refined the agency's National Registry of Evidence-based Programs and Practices (NREPP) based on a systematic analysis and consideration of public comments received in response to a previous Federal Register notice (70 FR 50381, Aug. 26, 2005). This Federal Register notice summarizes SAMHSA's redesign of NREPP as a decision support tool for promoting a greater adoption of evidence-based interventions within typical community-based settings, and provides an opportunity for interested parties to become familiar with the new system.

The Food and Drug Administration is correcting a proposed rule that appeared in the Federal Register of January 9, 2006 (71 FR 1399). That document proposed the reclassification of herpes simplex virus (types 1 and/or 2) serological assays from class III (premarket approval) to class II (special controls). That document inadvertently included a list of references related to a draft guidance that also was announced in the Federal Register of January 9, 2006 (71 FR 1432). The draft guidance contains the correct list of references. This document corrects the error.

On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified Southeast Asian countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird-derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/[H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A/H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 Federal Register 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1) , USDA/APHIS has added additional countries to its ban. On December 29, 2005, HHS/CDC added the Republic of Kazakhstan, Romania, the Russian Federation, the Republic of Turkey, and Ukraine to its current embargo because of documented cases of highly pathogenic avian influenza A/H5N1 in poultry in those countries. Currently, HHS/CDC and USDA/APHIS bans cover birds and bird products from Cambodia, Indonesia, Japan, Kazakhstan, Laos, Malaysia, the People's Republic of China, Romania, Russia, South Korea, Thailand, Turkey, Ukraine, and Vietnam. On February 7, 2006, the OIE confirmed the presence of highly pathogenic avian influenza H5N1 in poultry in Nigeria. At this time, HHS/CDC is adding Nigeria to its current embargo. This action is effective on February 8, 2006, and will remain in effect until further notice.

On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified Southeast Asian countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird-derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/ [H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 Federal Register 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OIE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. On December 29, 2005, HHS/CDC added the Republic of Kazakhstan, Romania, the Russian Federation, the Republic of Turkey, and Ukraine to its current embargo because of documented cases of highly pathogenic avian influenza H5N1 in poultry in those countries. On February 8, 2006, HHS/CDC added Nigeria to its embargo because of the documentation of highly pathogenic avian influenza H5N1 in poultry. On February 22, 2006, HHS/ CDC added India to its embargo because of documentation of highly pathogenic avian influenza H5N1 in poultry. On February 27, 2006, HHS/ CDC added Egypt to its embargo because of the documentation of highly pathogenic avian influenza H5N1 in poultry. Currently, HHS/CDC and USDA/APHIS bans cover birds and bird products from Cambodia, Egypt, India, Indonesia, Japan, Kazakhstan, Laos, Malaysia, Nigeria, the People's Republic of China, Romania, Russia, South Korea, Thailand, Turkey, Ukraine, and Vietnam. On February 28, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Niger. USDA added Niger to their ban on March 1, 2006. At this time, HHS/CDC is adding Niger to its current embargo. This action is effective on March 2, 2006, and will remain in effect until further notice.

In accordance with final regulations at 45 CFR part 61, implementing the Healthcare Integrity and Protection Data Bank (HIPDB), the Department is authorized to assess a fee on all requests for information, except requests from Federal agencies. In accordance with Sec. 61.13 of the HIPDB regulations, the Department is announcing an adjustment from $4.25 to $4.75 in the fee charged for each query submitted by authorized entities. There will be no change to the current $8 self-query fee.