Department of Health and Human Services March 22, 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 Services (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 with 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, added Egypt to its embargo because of documentation of highly pathogenic avian influenza H5N1 in poultry. On March 2, 2006, CDC issued an amendment adding Niger to its embargo after H5N1 was confirmed in poultry. On February 24, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Azerbaijan. On March 7, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Albania. On March 11, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Cameroon. On March 12, 2006, OIE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Myanmar. USDA/APHIS subsequently added Albania, Azerbaijan, Cameroon, and Myanmar to their ban. At this time, HHS/CDC is adding Albania, Azerbaijan, Cameroon, and Myanmar to its current embargo. This action is effective on March 15, 2006, and will remain in effect until further notice.

The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, ``Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses'' and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device.