[Federal Register Volume 72, Number 143 (Thursday, July 26, 2007)]
[Notices]
[Pages 41083-41084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3661]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0333]


Guidance; Emergency Use Authorization of Medical Products; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  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guidance finalizes the draft guidance published in the  Federal 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).

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  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.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

[[Page 41084]]

II. Comments

    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.

    Dated: July 20, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-3661 Filed 7-23-07; 12:28 pm]
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