Department of Health and Human Services March 10, 2006 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines,'' dated March 2006. The draft guidance document is intended to provide to sponsors of trivalent inactivated influenza vaccines guidance on the clinical data needed to support a Biologics License Application (BLA). The draft guidance summarizes clinical development approaches to facilitate and expedite the licensure of new trivalent inactivated influenza vaccines and addresses both traditional and accelerated approval.

The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing a fifty cent increase in the fee charged to entities authorized to request information from the National Practitioner Data Bank (NPDB) for all queries. The new fee will be $4.75. There will be no change to the $8.00 self-query fee.