[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Rules and Regulations]
[Page 61340-61342]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc03-10]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1 and 20
[Docket Nos. 2002N-0276 and 2002N-0278]
Interim Final Regulations Implementing Title III, Subtitle A, of
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002--Section 305: Registration of Food Facilities and Section
307: Prior Notice of Imported Food Shipments; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Public meetings on interim final rules.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a series
of domestic meetings to discuss
[[Page 61341]]
the interim final regulations, issued on October 10, 2003, to implement
two sections of the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Bioterrorism Act) regarding the
registration of food facilities and prior notice of imported food
shipments. The purpose of these meetings is to provide information on
the rules 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, 301-436-2277, FAX: 301-436-2605, e-mail: CFSAN-FSS@cfsan.fda.gov for general questions
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. On October 10, 2003, FDA published in the Federal
Register two interim final rules to implement sections 305
(Registration of Food Facilities) and 307 (Prior Notice of Imported
Food Shipments) of the Bioterrorism Act. During the public meetings,
FDA will explain the interim final rules on the registration of food
facilities and prior notice of imported food shipments, and the agency
will 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. Interim Final Rules
The interim final rules that will be discussed at the public
meetings announced in this document concern the following provisions of
the Bioterrorism Act:
Section 305: Registration of Food Facilities--The Bioterrorism Act
requires the owner, operator, or agent in charge of domestic and
foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States to register with FDA
no later than December 12, 2003. Farms, restaurants, retail food
establishments, nonprofit food establishments that prepare or serve
food directly to the consumer, and fishing vessels not engaged in
processing, as defined in 21 CFR 123.3(k), are exempt from this
requirement. Also exempt are foreign facilities if the food from the
facility undergoes further processing or packaging by another facility
outside of the United States and such processing is of more than a de
minimis nature.
Section 307: Prior Notice of Imported Food Shipments--The
Bioterrorism Act specifies that beginning on December 12, 2003, FDA
must receive prior notice of each article of food imported or offered
for import into the United States.
III. Registration for the Meetings
All attendees are asked to register for these meetings by
submitting registration information (including name, title, firm name,
address, telephone number, e-mail address, and fax number) at least 2
workdays before the particular meeting date. You may register online at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/fsbtac15.html or by fax at 202-479-6801.
Space is limited, and registration will be closed at a site when
maximum seating capacity for that site is reached (between 100 and 200
persons per site).
If you need special accommodations due to a disability, please
notify the contact person listed in the FOR FURTHER INFORMATION CONTACT
section of this document.
IV. Dates, Times, and Addresses of Public Meetings
A list of dates, times, and addresses for the domestic meeting is
provided in table 1:
Table1.--November 2003, Domestic Outreach Meetings--Section 305: Registration of Food Facilities and Section
307: Prior Notice of Imported Food Shipments
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Meeting Address Date and Local Time FDA Contact Person
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DETROIT: Marriott Detroit Metro Wednesday, November 12, 2003, 9 Marion Allen
Airport, 30559 Flynn Rd., Romulus, MI a.m. to 12 noon
48174
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LOS ANGELES: Hilton-Los Angeles Friday, November 14, 2003, 9 a.m. Do.
Airport, 5711 West Century Blvd., Los to 12 noon
Angeles, CA
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JAMAICA QUEENS: La Guardia Airport Monday, November 17, 2003, 9 a.m. Do.
Marriott Hotel, Ditmars Blvd., East to 12 noon
Elmhurst, NY 11369
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SAN ANTONIO: Westin Riverwalk, 420 Tuesday, November 18, 2003, 9 a.m. Do.
West Market St., San Antonio, TX to 12 noon
78205
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MIAMI: Marriott Miami Airport, 1201 NW Thursday, November 20, 2003, 9 a.m. Do.
LeJeune Rd. Miami, FL to 12 noon
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BALTIMORE: Hyatt Regency, 300 Light Friday, November 21, 2003, 9 a.m. Do.
St., Baltimore, MD to 12 noon
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Dated: October 22, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27182 Filed 10-23-03; 3:49 pm]
BILLING CODE 4160-01-S