[Federal Register: May 13, 2005 (Volume 70, Number 92)]
[Rules and Regulations]
[Page 25461-25462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my05-1]
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Rules and Regulations
Federal Register
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[[Page 25461]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 2002N-0277] (formerly 02N-0277)
Final Regulation Implementing the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--Establishment and
Maintenance of Records for Foods; Notice of Public Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meetings.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a series
of domestic public meetings to discuss the final regulation
implementing section 306 (Maintenance and Inspection of Records) of the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (Bioterrorism Act). The purpose of these public meetings is to
provide to the public information and an opportunity to ask questions
regarding the final rule.
DATES: See table 1 of the SUPPLEMENTARY INFORMATION section of this
document for meeting dates and times.
ADDRESSES: See table 1 of the SUPPLEMENTARY INFORMATION section of this
document for meeting locations.
FOR FURTHER INFORMATION CONTACT: For general questions about the
meeting: Marion V. Allen, Center for Food Safety and Applied Nutrition
(HFS-32), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-436-1584, FAX: 301-436-2605, e-mail:
marion.allen@fda.hhs.gov.
Please see III. Registration for the Public Meetings for
information on how to register for specific site locations.
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.
FDA published in the Federal Register of December 9, 2004 (69 FR
71562), the final rule implementing section 306 of the Bioterrorism Act
and a notice of availability for a draft guidance on records access
under the Bioterrorism Act (69 FR 71657). During the public meetings,
FDA will explain the final rule and draft guidance, and answer
questions for clarification.
II. Final Rule and Draft Guidance
Section 306 of the Bioterrorism Act directs the Secretary of Health
and Human Services (the Secretary) to issue final regulations that
establish requirements regarding the establishment and maintenance, for
not longer than 2 years, of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport, distribute,
receive, hold, or import food. The records required by these
regulations are those that are needed by the Secretary for inspection
to allow the Secretary to identify the immediate previous sources and
immediate subsequent recipients of food, including its packaging, in
order to address credible threats of serious adverse health
consequences or death to humans or animals. The regulation implements
the recordkeeping authority in the Bioterrorism Act.
In addition, the Bioterrorism Act provides records inspection
authority to FDA such that if FDA has a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse
health consequences or death to humans or animals, persons (excluding
farms and restaurants) who manufacture, process, pack, transport,
distribute, receive, hold, or import food must provide access to
records. FDA will also discuss the draft guidance for records access
authority provided for in the Bioterrorism Act, explaining how we will
implement access authority.
III. Registration for the Public Meetings
Please submit your registration information (including name, title,
firm name, address, telephone number, e-mail address, and fax number)
at least 5 workdays before the public meeting date. For specific site
locations, we encourage you to register online at http://www.cfsan.fda.gov/~dms/fsbtac26.html
or to fax your registration
directly to Isabelle Howes at 202-479-6801. We will accept
registrations onsite. Space is limited and registration will be closed
at each site when maximum seating capacity for that site is reached
(300 persons per site location).
If you need special accommodations due to a disability, please
notify the contact person listed under Contact in this document at
least 7 workdays in advance of the meeting.
All participants must present a valid photo identification when
entering a Federal building and parking facility.
IV. Dates, Times, and Addresses of Public Meetings
Table 1.--Public Meetings--Section 306: Establishment and Maintenance of
Records for Foods
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Date and Time Location
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Tuesday, June 7, 2005, 9 a.m. Marriott, 775 Brasilla Ave., Kansas
to 1 p.m., c.s.t. City, MO 64153, 816-464-2200
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Wednesday, June 8, 2005, 9 Los Angeles Airport Marriott, 5855 West
a.m. to 1 p.m., P.s.t. Century Blvd., Los Angeles, CA 90045,
310-641-5700
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Thursday, June 9, 2005, 9 a.m. Harvey W. Wiley Federal Bldg., 5100
to 1 p.m., e.s.t. Paint Branch Pkwy., College Park, MD
20740
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Tuesday, June 14, 2005, 9 a.m. Embassy Suites at Minneapolis Airport,
to 1 p.m., c.s.t. 7901 34th Ave., Bloomington, MN 55425,
952-854-1000
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Wednesday, June 15, 2005, 9 Atlanta, GA, Renaissance Waverly, 2450
a.m. to 1 p.m., e.s.t. Galleria Pkwy., Atlanta, GA 30339, 770-
953-4500
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[[Page 25462]]
V. Transcripts
A transcript will be made of the proceedings of each meeting. You
may request a copy of a meeting transcript in writing from FDA's
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 30
working days after the public meetings at a cost of 10 cents per page.
The transcript of each public meeting will be available for public
examination at the Division of Dockets Management (HFA-305), 5630
Fishers Lane, rm. 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m.,
Monday through Friday.
VI. Electronic Access
Information about the public meetings, contact information, and the
provisions of the Bioterrorism Act under FDA's jurisdiction can be
accessed at http://www.fda.gov/oc/bioterrorism/bioact.html and http://www.cfsan.fda.gov/~dms/fsbtact.html.
Dated: May 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9536 Filed 5-10-05; 4:13 pm]
BILLING CODE 4160-01-S
Domestic Outreach Grassroot Meetings - June 2005 -
FDA Updates: "Ensuring Compliance With the New Rule for Establishment and
Maintenance of Records Implementing Section 306 of the Bioterrorism Act"
