[Federal Register: April 8, 2003 (Volume 68, Number 67)]
[Proposed Rules]
[Page 16998-17000]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap03-25]
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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: CFSAN-FSS@cfsan.fda.gov, 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. jpittman@ora.fda.gov.------------------------------------------------------------------------
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:edenike@ora.fda.gov.------------------------------------------------------------------------
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:
ssmall@ora.fda.gov.------------------------------------------------------------------------
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: roma@ora.fda.gov.------------------------------------------------------------------------
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: CFSAN-
FSS@cfsan.fda.gov.------------------------------------------------------------------------
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