[Federal Register: December 9, 2004 (Volume 69, Number 236)]
[Rules and Regulations]
[Page 71655-71656]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09de04-26]
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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: marion.allen@fda.hhs.gov, 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rule implementing section 306 of the Bioterrorism Act and a draft
guidance on records access under the Bioterrorism Act.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public meetings, FDA will explain this rule and the draft guidance and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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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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
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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
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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.
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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