[Federal Register Volume 68, Number 208 (Tuesday, October 28, 2003)]
[Rules and Regulations]
[Pages 61340-61342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27182]


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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: [email protected] 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://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://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