[See Updated Downlink Location Information: Satellite Downlink Public Meeting I--Section 305: Registration of Food Facilities and Section 307: Prior Notice of Imported Food Shipments January 22, 2003]
[Federal Register: January 13, 2003 (Volume 68, Number 8)]
[Proposed Rules]
[Page 1568-1570]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja03-22]
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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: Louis.Carson@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: 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: dmonaco@ora.fda.gov
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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: dbailey@ora.fda.gov
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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:
shutchcr@ora.fda.gov
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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: smcconne@ora.fda.gov
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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: jsalazar@ora.fda.gov
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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: tonya.poindexter@cfsan.fda.gov
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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
Updated Downlink Location Information: Satellite Downlink Public Meeting I--Section 305: Registration of Food Facilities and Section 307: Prior Notice of Imported Food Shipments January 22, 2003