[Federal Register: December 9, 2004 (Volume 69, Number 236)]
[Notices]               
[Page 71657]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de04-103]                         



[[Page 71657]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004G-0381]

 
Draft Guidance for Records Access Authority Provided in Title 
III, Subtitle A, of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002; 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availability of a document entitled ``Draft Guidance for Records Access 
Authority Provided in Title III, Subtitle A, of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.'' The 
draft guidance is intended to clarify the circumstances under which FDA 
may access and copy records under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2003 (Bioterrorism Act) 
and establishes procedures to exercise its authority.

DATES: Submit written or electronic comments on the draft guidance by 
January 24, 2005, to ensure their adequate consideration in preparation 
of the final guidance. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Records Access Authority Provided in 
Title III, Subtitle A, of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002'' to Rudaina Alrefai (see FOR 
FURTHER INFORMATION CONTACT). Send one self-addressed adhesive label to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to this document. Submit 
written comments on the draft guidance to the Division of Dockets 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.


FOR FURTHER INFORMATION CONTACT: Rudaina Alrefai, Division of 
Compliance Information and Quality Assurance (HFC-240), Office of 
Enforcement, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6815, e-mail: rudaina.alrefai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Draft 
Guidance for Records Access Authority Provided in Title III, Subtitle 
A, of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002.'' The Bioterrorism Act created a new section 414 
(21 U.S.C. 350c) entitled ``Maintenance and Inspection of Records,'' in 
the Federal Food, Drug, and Cosmetic Act. Under this new authority, the 
Secretary of Health and Human Services (the Secretary) may by 
regulation establish requirements for persons (excluding farms and 
restaurants) who manufacture, process, pack, transport, distribute, 
receive, hold, or import food to establish and maintain food records. 
In addition, sections 414(a) and 704(a) (21 U.S.C. 374(a)) authorize 
FDA to access and copy all records related to an article of food if the 
following occurs: (1) The Secretary has a reasonable belief that an 
article of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals, and (2) the records 
are necessary to assist FDA in making such a determination.
    Elsewhere in this issue of the Federal Register, FDA is issuing a 
final rule entitled ``Establishment and Maintenance of Records Under 
the Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002,'' in which the agency is establishing requirements for 
persons (excluding farms and restaurants) who manufacture, process, 
pack, transport, distribute, receive, hold, or import food to establish 
and maintain food records.
    The purpose of this draft guidance is to describe the procedure 
that FDA intends to follow to exercise its new authority, and clarify 
the circumstances under which FDA may access and copy records under the 
Bioterrorism Act.
    The agency has adopted good guidance practices (GGPs) that set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (21 CFR 10.115). This draft 
guidance is being issued as a level 1 guidance consistent with GGPs. 
The draft guidance represents the agency's current thinking on the 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the draft 
guidance. 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 and the 
draft guidance may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html.


    Dated: November 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26931 Filed 12-6-04; 8:45 am]

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