[Federal Register Volume 68, Number 8 (Monday, January 13, 2003)]
[Proposed Rules]
[Pages 1568-1570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-660]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket Nos. 02N-0276 and 02N-0278]


Proposed Regulations Implementing Title III of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002; Notice 
of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; satellite downlink public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting (via satellite downlink) to discuss proposed regulations 
implementing two sections in Title III of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism 
Act) regarding Registration of Food Facilities (Docket No. 02N-0276) 
and Prior Notice of Imported Food Shipments (Docket No. 02N-0278). FDA 
expects to publish shortly in the Federal Register proposed rules 
implementing each of these provisions. The purpose of the satellite 
downlink public meeting is to provide information on the proposed rules 
to the public and to provide the public an opportunity to ask questions 
or to provide comment.

DATES: Satellite Downlink Public Meeting I--Wednesday, January 29, 
2003, 1 to 3 p.m. eastern standard time. Questions submitted in advance 
must be received by the contact person by close of business (4:30 p.m.) 
on January 24, 2003.

ADDRESSES: See SUPPLEMENTARY INFORMATION for locations where the 
satellite downlink may be viewed. A written transcript of the meeting 
will be available for viewing at Dockets Management Branch (DMB) (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, and through the Web site at http://www.fda.gov/oc/bioterrorism/bioact.html. A copy of the videotaped meeting may also be 
viewed at DMB.

FOR FURTHER INFORMATION CONTACT: Louis J. Carson, Center for Food 
Safety and Applied Nutrition (HFS-32), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2130, FAX: 
301-436-2605, e-mail: [email protected], for general questions 
about the downlink, submission of advance questions, and requests for a 
taped version of the meeting. Registration for specific downlink 
locations should be directed to the appropriate contact person listed 
in table 1 in the SUPPLEMENTARY INFORMATION section of this document.

SUPPLEMENTARY INFORMATION: The events of September 11, 2001, 
highlighted the need to enhance the security of the U.S. food supply. 
Congress responded by passing the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-
188), which was signed into law on June 12, 2002. The Bioterrorism Act 
includes four provisions in Title III (Protecting Safety and Security 
of Food and Drug Supply), Subtitle A (Protection of Food Supply) that 
require the Secretary of Health and Human Services, through FDA, to 
develop implementing regulations on an expedited basis. These four 
provisions are section 305 (Registration of Food Facilities); section 
307 (Prior Notice of Imported Food Shipments); section 306 (Maintenance 
and Inspection of Records for Foods); and section 303 (Administrative 
Detention). FDA soon will be publishing in the Federal Register notices 
of proposed rulemakings for each of these provisions. During the 
satellite downlink public meeting, FDA will explain the proposed rules 
on Registration of Food Facilities and Prior Notice of Imported Food 
Shipments and will answer questions. The satellite downlink public 
meeting will be offered in English with French and Spanish translation 
and will be simulcast live in English, French, and Spanish for North, 
Central, and South America (including, Hawaii and Alaska).
    Interested persons may submit questions concerning the proposals in 
advance of the downlink meeting. The deadline for the submission of 
questions is provided in the DATES section of this notice. Questions 
submitted in advance will be used by the session moderator to help 
clarify issues of concern and provide information about the

[[Page 1569]]

proposals. The viewing audience may telephone or fax questions to FDA 
officials during the live downlink.
    FDA is planning a second satellite downlink meeting during which 
FDA will explain the proposed rules that FDA will publish shortly to 
implement sections 306 and 303 of the Bioterrorism Act. That meeting 
will be announced in a future Federal Register notice. FDA also plans 
to develop additional regulations, safety measures, and guidance 
documents to implement other provisions of the Bioterrorism Act. 
Information about the public meetings, a list of additional non-FDA Web 
sites for viewing the public meetings, contact information, the 
provisions of the Bioterrorism Act under FDA's jurisdiction, and the 
agency's implementation plans are available at http://www.fda.gov/oc/bioterrorism/bioact.html.

Proposed rules

    The proposed regulations that will be addressed at the satellite 
downlink public meeting announced in this document concern the 
following provisions of the Bioterrorism Act:
    [sbull] 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, non-profit 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. FDA must issue final regulations no later 
than December 12, 2003, but facilities must register by this date in 
accordance with the Bioterrorism Act even if the regulations are not 
finalized. FDA plans to publish a final rule by October 12, 2003.
    [sbull] Section 307: Prior Notice of Imported Food Shipments--The 
Bioterrorism Act specifies that on or after December 12, 2003, FDA must 
receive prior notice of each article of food imported or offered for 
import into the United States. FDA must issue the final regulation by 
December 12, 2003. If the regulation is not final by that date, the 
Bioterrorism Act still requires FDA to receive prior notice of not less 
than 8 hours and not more than 5 days until the regulation takes 
effect. The agency plans to publish a final rule by October 12, 2003.
    A list of non-FDA parties providing other locations for viewing the 
downlink is provided in table 1 of this document. The parties listed 
are providing this service free of charge in the interest of providing 
information to their constituents and to assist in creating a public 
process.

Table 1.--Satellite Downlink Public Meeting I--Section 305: Registration
    of Food Facilities and Section 307: Prior Notice of Imported Food
                                Shipments
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                         Date: January 29, 2003
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                   Locations and Contact Information:
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Location: Advanced Training Center, 275 Oak St., Buffalo, NY 14203, 716-
 855-7050
Contact: Diana Monaco, U.S. FDA/Buffalo Office, 300 Pearl St., suite
 100, Buffalo, NY 14202, 716-551-4461, ext. 3118, FAX: 716-551-3845, e-
 mail: [email protected]
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Location: U.S. FDA, Chicago District Office, 550 W. Jackson Blvd., 16th
 floor, Chicago, IL 60661, 312-596-4205
Contact: Darlene Bailey, U.S. FDA/Chicago District Office, 550 W.
 Jackson Blvd., Chicago, IL 60661, 312-596-4205, FAX: 312-596-4170, e-
 mail: [email protected]
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Location: Lake Washington Technical School, 11605 132nd Ave. NE., rm. W-
 404, Kirkland, WA 98034, 425-739-8100
Contact: Sue Hutchcroft, U.S. FDA/Seattle District Office, 22201 23rd
 Dr., SE., Bothell, WA 98021, 425-483-4953, FAX: 425-483-4996, e-mail:
 [email protected]
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Location: VA Medical Center, 4th Floor Auditorium, 2002 Holcombe Blvd.,
 Houston, TX 77030, 713-794-7143
Contact: Sheryl McConnell, U.S. FDA/Dallas District Office Houston
 Resident Post, 1445 North Loop, West, suite 420, Houston, TX 77008, 713-
 802-9095, ext. 115, FAX: 713-802-0906, e-mail: [email protected]
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Location: Laredo Public Library, 1120 East Calton Rd., Laredo, TX 78041,
 956-795-2400
Contact: Julio Salazar, U.S. FDA/Southwest Import District, 715 Bob
 Bullock Loop, rm. 75, Laredo, TX 78045, 956-729-9691, ext. 1103, FAX:
 956-729-0997, e-mail: [email protected]
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Location: Center for Food Safety and Applied Nutrition, U.S. FDA,
 Auditorium, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2428
Contact: Tonya Poindexter, U.S. FDA/Center for Food Safety and Applied
 Nutrition, rm. 3B035, College Park, MD, 301-436-1544, FAX: 301-436-
 1584, e-mail: [email protected]
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    Registration: To register for the satellite downlink public 
meeting, contact the persons listed previously for the site you want to 
attend. Space is limited and registration will be closed at each site 
when maximum seating capacity for that site is reached (between 100-200 
persons per site). Send registration information (including name, 
title, firm name, address, telephone number, e-mail address, and fax 
number) to the contact identified in table 1 of this document at least 
2 workdays before the meeting. You may register by e-mail, fax, or 
telephone.
    If you need special accommodations due to a disability, please 
notify the contact person listed in table 1 of this document at least 7 
days in advance of the meeting.
    In addition, any interested parties with access to a satellite dish 
may view the downlink meetings at the following coordinates:
Live simulcast in English (channel 6.8), French (channel 5.8), and 
Spanish (channel 6.2)
For the United States (including Alaska and Hawaii) and Canada
    C Band
    Galaxy 9 @ 127 degrees west
    Ch 3 Horizontal
    Downlink frequency 3740 MHz
For South and Central America
    Digital
    PAS 9 @ 58 west
    Slot A Digital -
    Ch 24 Horizontal
    Downlink frequency 4160 MHz
    Video rebroadcasts will be played at several locations throughout 
the world. Dates, and viewing times for the video rebroadcasts for 
Europe, Asia, Australia, New Zealand can be found on FDA's bioterrorism 
Web site (http://www.fda.gov/oc/bioterrorism/bioact.html). Information 
on additional video rebroadcasts in English, Spanish,

[[Page 1570]]

and French will also be available at http://www.fda.gov/oc/bioterrorism/bioact.html.
    Transcripts: Within 3 weeks of the satellite downlink public 
meeting, written transcripts in English, French, and Spanish will be 
available for viewing at DMB (see ADDRESSES) and posted on the 
following Web sites: http://www.fda.gov/oc/bioterrorism/bioact.html. A 
written transcript of the satellite downlink meeting may be requested 
in writing from the Freedom of Information Office (HFI-35), Food and 
Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 
20857, within 3 weeks of the satellite downlink public meeting at a 
cost of 10 cents per page. Contact Lou Carson for a copy of the 
videotaped meeting. A copy of the video taped meeting may also be 
viewed at DMB.

    Dated: January 3, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-660 Filed 1-8-03; 4:09 pm]
BILLING CODE 4160-01-S