Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Emergency Use Authorization of Medical Products.” The guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. This guidance finalizes the draft guidance published in the Federal Register of July 5, 2005 (70 FR 38689).
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies of this guidance to the Office of Counterterrorism Policy and Planning (HF-29), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-827-5671. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Charlotte Christin, Office of Counterterrorism Policy and Planning (HF-29), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.End Further Info End Preamble Start Supplemental Information
FDA is announcing the availability of a guidance for industry, government agencies, and FDA staff entitled “Emergency Use Authorization of Medical Products.” This guidance describes the agency's general recommendations and procedures for issuance of emergency use authorizations (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-3), which was amended by the Project BioShield Act of 2004 (Public Law 108-276).
Section 564 of the act provides for authorization of “emergency use” of a medical product, after a declaration of emergency justifying an authorization is issued by the Secretary of Health and Human Services (the Secretary) based on one of the following grounds: A determination by the Secretary of Homeland Security that there is an actual or potential “domestic emergency;” a determination by the Secretary of Defense that there is an actual or potential “military emergency;” or a determination by the Secretary that there is a public health emergency under section 319 of the Public Health Service Act that affects or has the significant potential to affect national security. The Commissioner of Food and Drugs may issue an EUA for an unapproved drug, device, or biologic, or an unapproved use of an approved drug, device, or biologic, during a declared emergency if the statutory criteria set forth in section 564 of the act are met.
On July 5, 2005, FDA published for comment in the Federal Register a draft of this guidance. Comments received from industry, associations, health care professionals, consumers, and staff of other Federal agencies have been taken into consideration in finalizing this guidance. Changes are based on a thorough review of all comments received. As revised, the guidance includes a more detailed discussion of the scope of preemption (where applicable) and also provides points of contact for further information on several Federal liability protection and compensation programs.
This guidance document is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). It represents the agency's current thinking on emergency use authorizations of medical products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.Start Printed Page 41084
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). These collections of information have been approved under OMB control numbers 0910-0308, 0910-0230, 0910-0471, 0910-0014, 0910-0078, and 0910-0595.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at http://www.fda.gov/ohrms/dockets/default.htm.Start Signature
Dated: July 20, 2007.
Assistant Commissioner for Policy.
[FR Doc. 07-3661 Filed 7-23-07; 12:28 pm]
BILLING CODE 4160-01-S