[Federal Register Volume 69, Number 236 (Thursday, December 9, 2004)]
[Rules and Regulations]
[Pages 71655-71656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26930]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. 2002N-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 Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; public meeting on final rule.

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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), which is publishing in this issue of 
Federal Register. The purpose of these public meetings is to provide 
information on the rule to the public and to provide the public an 
opportunity to ask questions of clarification.

DATES: See table 1 of the SUPPLEMENTARY INFORMATION section of this 
document.

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

FOR FURTHER INFORMATION CONTACT: 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: <a href="/cdn-cgi/l/email-protection#4e232f3c272120602f22222b200e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="89e4e8fbe0e6e7a7e8e5e5ece7c9efede8a7e1e1faa7eee6ff">[email protected]</span></a>, for general questions 
only about the meeting.

SUPPLEMENTARY INFORMATION:

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.
    In this issue of the Federal Register, FDA is publishing the final 
rule implementing section 306 of the Bioterrorism Act and a draft 
guidance on records access under the Bioterrorism Act. During the 
public meetings, FDA will explain this rule and the draft guidance and 
answer questions of clarification.
    Information about the public meetings, contact information, and the 
provisions of the Bioterrorism Act under FDA's jurisdiction can be 
accessed at http://www.fda.gov/oc/bioterrorism/bioact.html.

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 that must be kept 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. This 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, and the records are 
necessary to assist FDA in making such a determination, persons 
(excluding farms and restaurants) who manufacture, process, pack, 
transport, distribute, receive, hold, or import food must provide 
access to records.

III. Registration for the Public Meetings

    Please submit your registration information (including name, title, 
firm name, address, telephone number, e-

[[Page 71656]]

mail address, and fax number) at least 5 working days before the public 
meeting date. For specific site locations, we encourage you to register 
online at http://www.cfsan.fda.gov/dms/fsbtac23.html or fax directly to 
Sharon Barcellos at 202-479-4970. We will accept registration onsite. 
Space is limited and registration will be closed at each site when 
maximum seating capacity for that site is reached (between 100 to 200 
persons per site). If you need special accommodations due to a 
disability, please notify the contact person as listed under FOR 
FURTHER INFORMATION CONTACT in this document at least 7 working days in 
advance of the meeting. All participants must present valid photo 
identification when entering a Federal building and parking facility.

IV. Dates, Times, and Addresses of Public Meetings

 Table 1.--Public Meeting--Section 306: Establishment and Maintenance of
                            Records for Foods
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               DATES                               LOCATION
------------------------------------------------------------------------
Thursday, January 13, 2005           Harvey W. Wiley Federal Bldg.
                                     5100 Paint Branch Pkwy.
                                     College Park, MD 20740
                                     Time: 9 a.m. to 1 p.m. EST
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Tuesday, January 25, 2005            Courtyard by Marriott Chicago
                                     165 E. Ontario St.
                                     Chicago, IL 60611
                                     312-573-0800
                                     Time: 9 a.m. to 1 p.m. CST
                                     ...................................
                                     Renaissance Seattle Hotel
                                     515 Madison St.
                                     Seattle, WA 98104
                                     800-546-9184
                                     Time: 9 a.m. to 1 p.m. PST
------------------------------------------------------------------------
Thursday, January 27, 2005           San Francisco Downtown Courtyard
                                     299 Second St.
                                     San Francisco, CA 94105
                                     415-947-0700
                                     Time: 9 a.m. to 1 p.m. PST
                                     ...................................
                                     Wyndham Orlando Resort
                                     8001 International Dr.
                                     Orlando, FL 32819
                                     407-351-2420
                                     Time: 9 a.m. to 1 p.m. EST
------------------------------------------------------------------------
Tuesday, February 1,2005             Renaissance Philadelphia Airport
                                      Hotel
                                     500 Stevens Dr.
                                     Philadelphia, PA 19113
                                     610-521-5900
                                     Time: 1 p.m. to 5 p.m.
                                     ...................................
                                     Hilton Boston Back Bay
                                     40 Dalton St.
                                     Boston, MA 02115
                                     617-236-1100
                                     Time: 9 a.m. to 1 p.m.
------------------------------------------------------------------------

IV. 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.

    Dated: December 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-26930 Filed 12-6-04; 8:45 am]
BILLING CODE 4160-01-S


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