[Federal Register Volume 68, Number 67 (Tuesday, April 8, 2003)]
[Proposed Rules]
[Pages 16998-17000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket Nos. 02N-0275 and 02N-0277]


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 (the 
Bioterrorism Act) regarding maintenance and inspection of records for 
foods (Docket No. 02N-0277) and administrative detention (Docket No. 
02N-0275). 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: The satellite downlink public meeting will be held on May 7, 
2003, 1 to 3 p.m., eastern standard time. Questions submitted in 
advance must be received by the contact person listed in the FOR 
FURTHER INFORMATION CONTACT section of this document by 4:30 p.m. on 
May 2, 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 (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, and at http://www.fda.gov/oc/bioterrorism/bioact.html. A copy 
of the videotaped meeting may also be viewed at the Dockets Management 
Branch.

FOR FURTHER INFORMATION CONTACT: Louis Carson, 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 
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:

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. 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). On February 3, 
2003, FDA published in the Federal Register notices of proposed 
rulemaking for registration of food facilities (68 FR 5378) and prior 
notice of imported food shipments (68 FR 5428), and will soon publish 
in the Federal Register notices of proposed rulemaking for maintenance 
and inspection of records for foods and administrative detention. 
During the satellite downlink public meeting, FDA will explain the 
proposed rules on maintenance and inspection of records for foods and 
administrative detention and will answer questions. The satellite 
downlink public meeting will be offered in English with simultaneous 
French and Spanish translation and will be simulcast live in English, 
French, and Spanish for North, Central, and South America (including 
Hawaii and Alaska).
    On January 29, 2003, FDA held a satellite downlink meeting during 
which FDA explained the proposed rules for registration of food 
facilities and prior notice of imported food shipments to implement 
sections 305 and 307 of the Bioterrorism Act, respectively. You may 
download a copy of the videotape of this meeting at http://
www.cfsan.fda.gov/[tilde]comm/vltbtact.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 Louis Carson for a copy of the videotaped meeting. A copy of 
the video taped meeting may also be viewed at the Dockets Management 
Branch.
    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.

II. Submitting Questions

    Interested persons may submit questions concerning the proposals in 
advance of the satellite 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 proposals during the downlink meeting. The viewing audience 
may also telephone, fax, or e-mail questions to FDA officials during 
the live downlink.

III. Proposed Regulations to be Addressed

    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:
    Section 303 (Administrative Detention) of the Bioterrorism Act 
authorizes FDA to detain food if the agency has credible evidence or 
information that the food presents a threat of serious adverse health 
consequences or death to humans or animals. The Bioterrorism Act 
requires FDA to issue regulations to provide procedures for instituting 
on an expedited basis certain enforcement actions against perishable 
foods, but it does not specify a deadline for a final regulation.
    Section 306 (Maintenance and Inspection of Records for Foods) of 
the Bioterrorism Act authorizes FDA, by regulation, to require persons 
that manufacture, process, pack, transport, distribute, receive, hold, 
or import food to create and maintain records that FDA determines are 
necessary to identify the immediate previous sources and the immediate 
subsequent recipients of food (i.e., where it came from and who 
received it). This would allow FDA to follow up on credible threats of 
serious adverse health consequences or death to

[[Page 16999]]

humans or animals by tracing the food back to its source and tracing 
the food forward to all recipients. Farms and restaurants are exempt 
from any recordkeeping regulations that are issued by FDA. The statute 
requires FDA to issue final regulations by December 12, 2003.

IV. Sites for Viewing the Downlink Public Meeting

    A list of non-FDA parties providing other locations for viewing the 
downlink public meeting 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.--May 7, 2003, Satellite Downlink Public Meeting to Discuss
 Proposed Regulations Implementing Section 303: Administrative Detention
 and Section 306: Maintenance and Inspection of Records for Foods of the
                            Bioterrorism Act
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             Locations                       Contact Information
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Department of Veterans Affairs       JoAnn Pittman, U.S. FDA/Atlanta
 Medical Center, Pete Wheeler         District Office, 60 8th St., NE.,
 Auditorium, 1670 Clairmont Rd.,      Atlanta, GA 30309, 404-253-1272,
 Decatur, GA 30033, 404-321-6111,     FAX: 404-253-1202, email:
 ext. 6050.                           [email protected].
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U.S. FDA, Detroit District Office,   Evelyn DeNike, U.S. FDA/Detroit
 300 River Pl., suite 5900,           District Office, 300 River Pl.,
 Detroit, MI 48207-4291, 313-393-     suite 5900, Detroit, MI 48207-
 8109.                                4291, 313-393-8109, FAX: 313-393-
                                      8139, email:[email protected].
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Massachusetts Department of Public   Susan Small, U.S. FDA/New England
 Health, Division of Food and         District Office, One Montvale
 Drugs, 305 South St., Jamaica        Ave., Stoneham, MA 02180, 781-596-
 Plain, MA 02130, 617-983-6767.       7779, FAX: 781-596-7896, email:
                                      [email protected].
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University of California Irvine, C-  Ramlah I. Oma, U.S. FDA/Los Angeles
 127 Student Center (at E. Peltason/  District Office, 19900 MacArthur
 Periera), Emerald Bay B and C,       Blvd., suite 300, Irvine, CA 92612-
 Irvine, CA 92697.                    2445, 949-798-7611, FAX: 949-798-
                                      7656, email: [email protected].
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Center for Food Safety and Applied   Contact: Tonya Poindexter, U.S. FDA/
 Nutrition, U.S. FDA, Auditorium,     Center for Food Safety and Applied
 5100 Paint Branch Pkwy., College     Nutrition, rm. 3B035, College
 Park, MD, 301-436-2428.              Park, MD 20740, 301-436-2277, FAX:
                                      301-436- 2605, email: [email protected].
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    In addition, any interested parties with access to a satellite dish 
may view the downlink meeting at the following coordinates:
    Live simulcast in English (channel 6.8), French (channel 5.8), and 
Spanish (channel 6.2).
    Pre-event Test: A pre-event test for U.S. downlink sites only will 
be provided on May 6 from 12 noon EST to 1 p.m. EST. During that hour, 
technical assistance will be available through a trouble line at 1-888-
626-8730.'' This is a test of Galaxy 9, Transponder 3 only.

                                                         U.S.--C-Band: Galaxy 9 127 degrees West
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                   Transponder                          Polarization                 Channel               Downlink Freq.                 Audio
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3                                                                Vertical                         3                  3760 MHz               6.8 English
                                                                                                                                            6.2 Spanish
                                                                                                                                             5.8 French
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                              Mexico & South America--C-Band: PAS 9 58 degrees West
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 Transponder     Polarization           Channel        Digital Settings     Downlink Freq.           Audio
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24                   Horizontal                  24               4:2:0          4164.5 MHz         6.8 English
Slot C -      ..................  ..................                 FEC 3..................        6.2 Spanish
 Digital                                              Symbol Rate: 5.632                             5.8 French
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    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, and French will 
also be available at http://www.fda.gov/oc/bioterrorism/bioact.html.
    Videostream copies of the satellite downlink meeting will be 
available in English, Spanish, and French on CD-ROM within 10 working 
days after the meeting. Copies of the meeting will also be available on 
videotape cassettes in English, Spanish, and French in NTSC (VHS), PAL, 
PAL-N and SECAM formats. Contact Louis Carson for a copy of the meeting 
on CD-ROM or videotape. Videotape requests must specify language and 
format. A videostream of the meeting will be posted on FDA's Web site 
at http://www.fda.gov/oc/bioterrorism/bioact.html.

V. Registration

    To register for the satellite downlink public meeting, contact the 
persons

[[Page 17000]]

listed in table 1 in this document for the site you want to attend. 
Space is limited and registration will be closed at each site once 
maximum seating capacity for that site is reached (between 100 and 200 
people per site). Send registration information (including name, title, 
firm name, address, telephone number, e-mail address, and fax number) 
for each attendee to the contact identified in table 1 of this document 
no later than May 5, 2003. 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.

VI. Transcripts

    Within 3 weeks of the satellite downlink public meeting, written 
transcripts in English, French, and Spanish will be available for 
viewing at the Dockets Management Branch (see ADDRESSES) and posted on 
the following Web site: 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 Louis Carson for a copy of the 
videotaped meeting. A copy of the video taped meeting may also be 
viewed at the Dockets Management Branch.

    Dated: April 2, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8576 Filed 4-3-03; 4:18 pm]
BILLING CODE 4160-01-S