[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Draft Guidance for Records Access Authority Provided in Title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availability of a document entitled ``Draft Guidance for Records Access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draft guidance is intended to clarify the circumstances under which FDA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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Records Access Authority Provided in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written comments on the draft guidance to the Division of Dockets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://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://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]
 
BILLING CODE 4160-01-S

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 December 2004