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Federal Register/Vol. 70, No. 21/Wednesday, February 2, 2005/Notices

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Federal Register/Vol. 70, No. 21/Wednesday, February 2, 2005/Notices 5452 Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: HUMAN SERVICES HUMAN SERVICES I. Background Administration for Children and Food and Drug Administration Section 564 of the act (21 U.S.C. Families [Docket No. 2005N–0040] 360bbb–3), as amended by the Project BioShield Act of 2004 (Public Law 108– Delegation of Authority Authorization of Emergency Use of 276), allows FDA to strengthen the Anthrax Vaccine Adsorbed for public health protections against Notice is hereby given that, under the Prevention of Inhalation Anthrax by biological, chemical, nuclear, and authority vested in me by the Secretary, Individuals at Heightened Risk of radiological agents. Among other things, Department of Health and Human Exposure Due to Attack With Anthrax; section 564 of the act allows FDA to Services, I have redelegated to the Availability authorize the use of an unapproved Commissioner, Administration on medical product or an unapproved use Children, Youth and Families, with the AGENCY: Food and Drug Administration, of an approved medical product during authority to further redelegate to the HHS. a declared emergency involving a Director, Family Youth Services Bureau, ACTION: Notice. heightened risk of attack on the public the authority to approve/disapprove or U.S. military forces. With this EUA SUMMARY: The Food and Drug authority, FDA can help assure that cooperative research or demonstration Administration (FDA) is announcing the medical countermeasures may be used projects under Section 1110 of the issuance of an Emergency Use in an emergency to diagnose, treat, or Social Security Act, and as amended Authorization (EUA) (the Authorization) prevent serious or life-threatening hereafter, when such projects pertain to for Anthrax Vaccine Adsorbed (AVA) diseases or conditions caused by such the abstinence education activities for prevention of inhalation anthrax for agents, when there are no adequate, referenced in Public Law 108–447 at individuals between 18 and 65 years of approved, and available alternatives to Title II, Division F. age who are deemed by the Department protect the American people and the of Defense (DoD) to be at heightened This delegation excludes the authority U.S. military. to submit reports to Congress. Further, risk of exposure due to attack with anthrax. FDA is issuing this Section 564(b)(1) of the act provides this delegation shall be exercised under that, before an EUA may be issued, the the Department’s existing delegation Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as Secretary must declare an emergency and policy on regulations and under based on one of the following grounds: financial and administrative requested by DoD. The Authorization contains, among other things, (1) a determination by the Secretary of requirements applicable to all Homeland Security that there is a domestic Administration for Children and conditions on the emergency use of emergency, or a significant potential for a AVA. The Authorization follows the Families authorities. In addition, where domestic emergency, involving a heightened determination by DoD that there is a all or part of any research or risk of attack with a specified biological, significant potential for a military chemical, radiological, or nuclear agent or demonstration project is wholly emergency involving a heightened risk agents; financed with Federal funds made to U.S. military forces of attack with (2) a determination by the Secretary of available under section 1110 of the anthrax. On the basis of such Defense that there is a military emergency, or Social Security Act, without any State, determination, Secretary of Health and a significant potential for a military local, or other non-Federal financial Human Services Tommy G. Thompson emergency, involving a heightened risk to United States military forces of attack with a participation, that project must be (the Secretary) declared an emergency approved by the Secretary of Health and specified biological, chemical, radiological, justifying the authorization of the or nuclear agent or agents; or Human Services. emergency use of AVA. The (3) a determination by the Secretary of a I have ratified any actions taken by Authorization, which includes an public health emergency under section 319 of the Commissioner, Administration on explanation of the reasons for its the Public Health Service Act (PHS Act) that Children, Youth and Families, or any issuance, is reprinted in this Notice. affects, or has a significant potential to affect, national security, and that involves a DATES: The Authorization is effective as other Administration on Children, specified biological, chemical, radiological, Youth and Families officials, which, in of January 27, 2005. or nuclear agent or agents, or a specified effect, involved the exercise of this ADDRESSES: Submit written requests for disease or condition that may be attributable authority prior to the effective date of single copies of the Emergency Use to such agent or agents. this delegation. This delegation was Authorization to the Office of Once the Secretary has declared an effective on the date of signature. Counterterrorism Policy and Planning emergency justifying an authorization (HF–29), Food and Drug Dated: January 21, 2005. under section 564 of the act, FDA may Administration, 5600 Fishers Lane, authorize the emergency use of a drug, Wade F. Horn, Rockville, MD 20857. Send one self- device, or biological product if the Assistant Secretary for Children and Families. addressed adhesive label to assist that agency concludes, based on the [FR Doc. 05–1896 Filed 2–1–05; 8:45 am] office in processing your request or information and data available to the BILLING CODE 4184–01–M include a fax number to which the agency, that the statutory criteria of Authorization may be sent. See the section 564(c) of the act are satisfied. SUPPLEMENTARY INFORMATION section for Under section 564(h)(1) of the act FDA electronic access to the Authorization. is required to publish in the Federal FOR FURTHER INFORMATION CONTACT: Register notice of each authorization, Margaret O’K. Glavin, Office of and each termination or revocation of an Counterterrorism Policy and Planning authorization, and an explanation of the (HF–29), Food and Drug reasons for the action. The explanation Administration, 5600 Fishers Lane, may include a summary of data Rockville, MD 20857, 301–827–4067. submitted to FDA in an application VerDate jul<14>2003 14:19 Feb 01, 2005 Jkt 205001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1 Federal Register / Vol. 70, No. 21 / Wednesday, February 2, 2005 / Notices 5453 under section 505(i) or 520(g) of the act Thompson declared an emergency www.fda.gov/ohrms/dockets/ (21 U.S.C. 355(i) or 21 U.S.C. 360j(g)). justifying the authorization of the default.htm. Section 564 of the act permits FDA to emergency use of AVA. Notice of the authorize, during the effective period of determination of the Deputy Secretary V. The Authorization the declaration, the introduction into of Defense and the declaration of the Having consulted with NIH and CDC, interstate commerce of a drug, device, or Secretary of Health and Human Services and having concluded that the criteria biological product intended for use in is published elsewhere in this issue of for issuance of this Authorization under an actual or potential emergency. the Federal Register. Products appropriate for emergency use section 564(c) of the act are met, FDA may include products and uses that are III. Significance of Notice has authorized the emergency use of AVA for prevention of inhalation not approved, cleared, or licensed under The issuance of this Authorization for anthrax for individuals between 18 and sections 505, 510(k), and 515 of the act the emergency use of AVA is the first (21 U.S.C. 355, 21 U.S.C. 360(k), 21 time that the EUA authority is being 65 years of age who are deemed by DoD U.S.C. 360e) or section 351 of the PHS used. FDA intends to explain clearly the to be at heightened risk of exposure due Act (42 U.S.C. 262). FDA may issue an reasons for each issuance, termination, to attack with anthrax. The EUA only if, after consultation with the or revocation of an EUA. The agency Authorization follows and provides an National Institutes of Health (NIH) and wishes to make its decision-making explanation of the reasons for its the Centers for Disease Control and understandable to help ensure that issuance, as required by section Prevention (CDC) (to the extent feasible members of the public, and particularly 564(h)(1) of the act: and appropriate given the circumstances those individuals who may be eligible to William Winkenwerder, Jr., M.D. of the emergency), FDA concludes: receive a medical product authorized for (1) That the agent specified in the Assistant Secretary of Defense for Health emergency use, are informed about the Affairs declaration of emergency can cause a basis of an EUA determination. The serious or life-threatening disease or The Pentagon amount of information that will be Washington, D.C. 20301–1200 condition; provided regarding each authorization (2) That, based on the totality of Re: Request for Emergency Use will depend on the circumstances of the scientific evidence available, including Authorization for the Armed Forces Pending emergency. We anticipate that in some data from adequate and well-controlled Re-determination on the Licensed Use of circumstances, an EUA will be issued Anthrax Vaccine Adsorbed for Protection clinical trials, if available, it is very quickly, and time may not permit Against Inhalational Anthrax reasonable to believe that the product the agency to prepare supplementary Dear Dr. Winkenwerder: may be effective in diagnosing, treating, documents beyond the letter of This is in response to your letter of or preventing—(a) the serious or life- authorization and the notice required by December 22, 2004, requesting that the Food threatening disease or condition referred section 564(h)(1) of the act.
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