[Federal Register: May 13, 2005 (Volume 70, Number 92)]
[Rules and Regulations]               
[Page 25461-25462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

Rules and Regulations
                                                Federal Register

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

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[[Page 25461]]


Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-0277] (formerly 02N-0277)

Final Regulation Implementing the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002--Establishment and 
Maintenance of Records for Foods; Notice of Public Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings.


SUMMARY: The Food and Drug Administration (FDA) is announcing a series 
of domestic public meetings to discuss the final regulation 
implementing section 306 (Maintenance and Inspection of Records) of the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002 (Bioterrorism Act). The purpose of these public meetings is to 
provide to the public information and an opportunity to ask questions 
regarding the final rule.

DATES: See table 1 of the SUPPLEMENTARY INFORMATION section of this 
document for meeting dates and times.

ADDRESSES: See table 1 of the SUPPLEMENTARY INFORMATION section of this 
document for meeting locations.

FOR FURTHER INFORMATION CONTACT: For general questions about the 
meeting: Marion V. Allen, Center for Food Safety and Applied Nutrition 
(HFS-32), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, 301-436-1584, FAX: 301-436-2605, e-mail: 
    Please see III. Registration for the Public Meetings for 
information on how to register for specific site locations.


I. Background

    The events of September 11, 2001, highlighted the need to enhance 
the security of the U.S. food supply. Congress responded by passing the 
Bioterrorism Act (Public Law 107-188), which was signed into law on 
June 12, 2002.
    FDA published in the Federal Register of December 9, 2004 (69 FR 
71562), the final rule implementing section 306 of the Bioterrorism Act 
and a notice of availability for a draft guidance on records access 
under the Bioterrorism Act (69 FR 71657). During the public meetings, 
FDA will explain the final rule and draft guidance, and answer 
questions for clarification.

II. Final Rule and Draft Guidance

    Section 306 of the Bioterrorism Act directs the Secretary of Health 
and Human Services (the Secretary) to issue final regulations that 
establish requirements regarding the establishment and maintenance, for 
not longer than 2 years, of records by persons (excluding farms and 
restaurants) who manufacture, process, pack, transport, distribute, 
receive, hold, or import food. The records required by these 
regulations are those that are needed by the Secretary for inspection 
to allow the Secretary to identify the immediate previous sources and 
immediate subsequent recipients of food, including its packaging, in 
order to address credible threats of serious adverse health 
consequences or death to humans or animals. The regulation implements 
the recordkeeping authority in the Bioterrorism Act.
    In addition, the Bioterrorism Act provides records inspection 
authority to FDA such that if FDA 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, persons (excluding 
farms and restaurants) who manufacture, process, pack, transport, 
distribute, receive, hold, or import food must provide access to 
records. FDA will also discuss the draft guidance for records access 
authority provided for in the Bioterrorism Act, explaining how we will 
implement access authority.

III. Registration for the Public Meetings

    Please submit your registration information (including name, title, 
firm name, address, telephone number, e-mail address, and fax number) 
at least 5 workdays before the public meeting date. For specific site 
locations, we encourage you to register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/fsbtac26.html
 or to fax your registration 

directly to Isabelle Howes at 202-479-6801. We will accept 
registrations onsite. Space is limited and registration will be closed 
at each site when maximum seating capacity for that site is reached 
(300 persons per site location).
    If you need special accommodations due to a disability, please 
notify the contact person listed under Contact in this document at 
least 7 workdays in advance of the meeting.
    All participants must present a valid photo identification when 
entering a Federal building and parking facility.

IV. Dates, Times, and Addresses of Public Meetings

Table 1.--Public Meetings--Section 306: Establishment and Maintenance of
                            Records for Foods
         Date and Time                          Location
Tuesday, June 7, 2005, 9 a.m.   Marriott, 775 Brasilla Ave., Kansas
 to 1 p.m., c.s.t.               City, MO 64153, 816-464-2200
Wednesday, June 8, 2005, 9      Los Angeles Airport Marriott, 5855 West
 a.m. to 1 p.m., P.s.t.          Century Blvd., Los Angeles, CA 90045,
Thursday, June 9, 2005, 9 a.m.  Harvey W. Wiley Federal Bldg., 5100
 to 1 p.m., e.s.t.               Paint Branch Pkwy., College Park, MD
Tuesday, June 14, 2005, 9 a.m.  Embassy Suites at Minneapolis Airport,
 to 1 p.m., c.s.t.               7901 34th Ave., Bloomington, MN 55425,
Wednesday, June 15, 2005, 9     Atlanta, GA, Renaissance Waverly, 2450
 a.m. to 1 p.m., e.s.t.          Galleria Pkwy., Atlanta, GA 30339, 770-

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V. Transcripts

    A transcript will be made of the proceedings of each meeting. You 
may request a copy of a meeting transcript in writing from FDA's 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 30 
working days after the public meetings at a cost of 10 cents per page. 
The transcript of each public meeting will be available for public 
examination at the Division of Dockets Management (HFA-305), 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m., 
Monday through Friday.

VI. Electronic Access

    Information about the public meetings, contact information, and the 
provisions of the Bioterrorism Act under FDA's jurisdiction can be 
accessed at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/bioterrorism/bioact.html and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/fsbtact.html.
    Dated: May 9, 2005.

Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9536 Filed 5-10-05; 4:13 pm]