[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]



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.


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 

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.

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
             Locations                       Contact Information
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

[[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
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
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
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
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., College     FSS@cfsan.fda.gov
 Park, MD 20740
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
South Texas Community College        ...................................
 Technology Center, 3700 West
 Military Hwy., McAllen, TX 78503-
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
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
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

    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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).

                   Transponder                          Polarization                 Channel               Downlink Freq.                 Audio
3                                                              Horizontal                         3                  3760 MHz          6.8 English only
                                                                                                                                            6.2 Spanish
                                                                                                                                             5.8 French

 Transponder     Polarization           Channel         Downlink Freq.
Slot A               Horizontal                  24          4164.5 MHz

    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/bioterrorism/bioact.html.
 Information on additional video rebroadcasts in English, 

[[Page 56603]]

and French will also be available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 

    Dated: September 26, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-24921 Filed 9-26-03; 4:13 pm]