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[Federal Register: October 1, 2003 (Volume 68, Number 190)]
[Proposed Rules]
[Page 56600-56603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc03-37]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket Nos. 2002N-0276 and 2002N-0278]
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: Announcement of 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 final 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. 2002N-0276)
and Prior Notice of Imported Food Shipments (Docket No. 2002N-0278).
FDA expects to publish shortly in the Federal Register final rules
implementing each of these provisions. The purpose of the satellite
downlink public meeting is to provide information on the rules to the
public and to provide the public an opportunity to ask questions of
clarification.
DATES: The satellite downlink public meeting will be held on Tuesday,
October 28, 2003, from 1 p.m. 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 Friday, October 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 the Division of Dockets Management
(DDM) (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 DDM.
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, 301-436-2277, 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
videotaped 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
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 expects that
the agency will soon publish in the Federal Register final rules to
implement sections 305 and 307 of the Bioterrorism Act. During the
satellite downlink public meeting, FDA will explain the final 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 Mexico
and North, Central, and South America (including Hawaii and Alaska).
II. Submitting Questions
Interested persons may submit questions concerning the final rules
in advance of the downlink meeting. The deadline for the submission of
questions is provided in the DATES section of this document. Questions
submitted in advance will be used by the session moderator to help
clarify issues of concern and provide information about the final
rules. The viewing audience may telephone or fax questions to the FDA
participants during the live downlink.
FDA is planning a second satellite downlink meeting during which
FDA will explain the final rules that FDA intends to publish later this
year to implement sections 306 and 303 of the Bioterrorism Act. That
meeting will be
[[Page 56601]]
announced in a future Federal Register document.
Information about the public meetings, contact information, and the
provisions of the Bioterrorism Act under FDA's jurisdiction may be
found on the agency's Web site, http://www.fda.gov/oc/bioterrorism/bioact.html.
III. Final Rules
The final regulations that will be addressed at the satellite
downlink public meeting 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, 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 of more than a de
minimus nature 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 registration final rule by October 10, 2003.
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 prior notice final rule by
October 10, 2003.
IV. Sites for Viewing the Downlink Public Meeting
A list of locations for viewing the downlink public meeting is
provided in table 1 of this document.
Table 1.--October 28, 2003, Satellite Downlink Public Meeting I--Section
305: Registration of Food Facilities and Section 307: Prior Notice of
Imported Food Shipments
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Locations Contact Information
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FDA New York District Office, 158- Marilyn Corretto, 718-662-5461;
15 Liberty Ave., Jamaica, NY 11433 FAX: 718-662-5434; e-mail:
mcorrett@ora.fda.gov
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FDA Buffalo Office, 300 Pearl St., Robert Hart, 716-551-4461 X3142;
Buffalo, NY 14202 FAX: 716-551-3813; e-mail:
Rhart@ora.fda.gov
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Plattsburgh Area, Angell Center, Todd Manning, 518-298-8240; FAX:
Plattsburgh Room, Plattsburgh 518-298-5538; e-mail:
State University of NY (PSUNY) tmanning@ora.fda.gov
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FDA Chicago District Office, 550 Darlene Bailey, 312-353-7126; FAX:
West Jackson, 16th floor, Chicago, 312-596-4195; e-mail:
IL 60661 dbailey@ora.fda.gov
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Ronald V. Dellums Federal Bldg., Marcia Madrigal, 510-637-3980; FAX:
1301 Clay St., 3d floor, North 510-637-3976; e-mail:
Tower, Oakland, CA 94612 mmadriga@ora.fda.gov
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FDA/Southwest Import District, 4040 Robert Deininger, 214-253-5322;
North Central Expressway, suite FAX: 214-253-5317; e-mail:
300, Dallas, TX 75204 rdeining@ora.fda.gov
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Memphis Marriot East, 2625 Thousand Sandra Baxter, 615-781-5385 X122;
Oaks Dr., Memphis, TN 38118 FAX: 615-781-5383; e-mail:
sbaxter@ora.fda.gov
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FDA Detroit District Office, 300 Evelyn DeNike, 313-393-8109; FAX:
River Pl., suite 5900, Detroit, MI 313-393-8139; e-mail:
48207 edenike@ora.fda.gov
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Bishop Henry Whipple Federal Bldg., Amy C. Johnson, 612-758-7131; FAX:
One Federal Dr., rm. G-110, Saint 612-334-4134; e-mail:
Paul, MN 55111-4008 acjohnso@ora.fda.gov
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Florida Department of Agriculture Courtney Hunt, 850-942-8325; FAX:
and Consumer Services (FDACS), 850-942-8326; e-mail:
George Eyster Auditorium, 3125 chunt@ora.fda.gov
Connor Blvd., Tallahassee, FL
32399
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Tampa Port Authority, 1101 Jean Peeples, 813-228-2671 X18;
Channelside Dr., 1st Floor Board FAX: 813-228-2046; e-mail:
Room, Tampa, FL 33602 Jpeeples@ora.fda.gov
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Miami Free Zone, 2305 NW. 107th Estela N. Brown, 786-437-4838; FAX:
Ave., 1st Floor Conference Room, 786-437-4866; e-mail:
Miami, FL 33172 Ebrown1@ora.fda.gov
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FDA Atlanta District Office, 60 8th JoAnn Pittman, 404-253-1272; FAX:
Street, NE., Atlanta, GA 30309 404-253-1202; e-mail:
jpittman@ora.fda.gov
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FDA Kansas City District Office, Tywanna Paul, 913-752-2141; FAX:
11630 W. 80th St., Annex 913-752-2111; e-mail:
Conference Room, Lenexa, KS 66214 tpaul@ora.fda.gov
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FDA New England District Office, Susan Small, 781-596-7779: FAX: 781-
One Montvale Ave., Stoneham, MA 596-7896; e-mail:
02180 Ssmall@ora.fda.gov
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[[Page 56602]]
FDA Kansas City District Office, 12 Don Aird, 314-645-1167; FAX: 314-
Sunnen Dr., suite 122, St. Louis, 645-2969; e-mail:
MO 63143 daird@ora.fda.gov
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FDA Cincinnati District Office, Bonny Carzoli, 513-679-2700 x 115.;
6751 Steger Dr., Cincinnati, OH FAX: 513-679-2771; e-mail:
45237-3097 bcarzoli@ora.fda.gov
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Portland Innovative Food Center, Alan Bennett, 503-671-9332; FAX:
1207 NW. Naito Pkwy., Portland, OR 503-671-9445; e-mail:
97209 abennett@ora.fda.gov
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Lake Washington Technical College, Stephanie Magill, 425-483-4953;
11605 132d Ave., NE., Kirkland, WA FAX: 425-483-4996; e-mail:
98034. stephanie.magill@fda.gov
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Center for Food Safety and Applied Marion Allen, 301-436-2277, FAX:
Nutrition, U.S. FDA, Auditorium, 301-436-2605, e-mail:
CFSAN- 5100 Paint Branch Pkwy., FSS@cfsan.fda.gov
College Park, MD 20740
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Texas A&M International University, Adrian Garcia, 520-281-1100, FAX:
WHTC Bldg., rm. 116, 5201 520-281-1190, e-mail:
University, KL 262, Laredo TX agarcia@ora.fda.gov
78041-1900
South Texas Community College ...................................
Technology Center, 3700 West
Military Hwy., McAllen, TX 78503-
8807
Arizona Western College, College ...................................
Union Bldg., Palo Verde Room, 2020
South Avenue 8E, Yuma, AZ 85364
PIMA Community College, 401 N. ...................................
Bonita Ave., Tucson, AZ 85709
Health Services Complex, Rosecrans ...................................
Bldg., 3851 Rosecrans St., San
Diego, CA 92110
University of El Paso, ...................................
Undergraduate Learning Center, rm.
110, 500 West University Ave., El
Paso, TX 79905
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FDA/Denver District Office, Denver Virlie Walker/Devin Koontz, 303-236-
Federal Center, Bldg. [numsign]20, 3018/3020, FAX: 303-236-3551, e-
Sixth & Kipling, Lakewood, CO mail: vwalker@ora.fda.gov
80225 dkoontz@ora.fda.gov
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VA Medical Center, 4th Floor Sheryl McConnell, 713-802-7534,
Auditorium, 2202 Holcombe, Houston FAX: 713-802-7503, e-mail:
TX 77030 smcconne@ora.fda.gov
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The sites presented in table 1 of this document are the sites
scheduled to broadcast the satellite downlink as of the publication of
this document. Please check the FDA Web site at http://www.fda.gov/oc/bioterrorism/bioact.html
for additional sites that may be added.
V. Registration
All attendees are asked to preregister for the satellite downlink
public meeting by contacting the person listed in table 1 of this
document 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. 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).
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Transponder Polarization Channel Downlink Freq. Audio
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3 Horizontal 3 3760 MHz 6.8 English only
6.2 Spanish
5.8 French
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Transponder Polarization Channel Downlink Freq.
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Slot A Horizontal 24 4164.5 MHz
Digital
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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, South Africa, and New Zealand may be found on
FDA's bioterrorism Web site at http://www.fda.gov/oc/bioterrorism/bioact.html.
Information on additional video rebroadcasts in English,
Spanish,
[[Page 56603]]
and French will also be available at http://www.fda.gov/oc/bioterrorism/bioact.html.
VI. Transcripts
Within 3 weeks of the satellite downlink public meeting, written
transcripts in English, French, and Spanish will be available for
viewing at DDM (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, 3 weeks after the
satellite downlink public meeting at a cost of 10 cents per page. A
copy of the videotaped meeting may also be viewed at DDM. Or you may
contact Lou Carson for a copy of the videotaped meeting and specify
format and language.
Pre-event Test: A pre-event test for downlink sites will be
provided on October 28 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.
Dated: September 26, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-24921 Filed 9-26-03; 4:13 pm]
BILLING CODE 4160-01-S
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