[Federal Register: December 16, 2003 (Volume 68, Number 241)]
[Rules and Regulations]
[Page 69957-69958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de03-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 2002N-0278]
Guidance for Industry: Questions and Answers on the Interim Final
Rule on Prior Notice of Imported Food; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability of guidance.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Prior Notice of Imported Food,
Questions and Answers.'' The guidance responds to various questions
raised about the section 307 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act) and the agency's implementing regulations that require, beginning
on December 12, 2003, prior notice to FDA before food is imported or
offered for import into the United States.
DATES: Submit written or electronic comments on the agency guidance at
any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Prior Notice Help Desk, phone 1-800-216-7331 or 301-575-0156, or
Fax 301-210-0247. See the Supplementary Information section for
electronic access to the guidance document.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of
Regulatory Affairs (HFC-100), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 781-596-7785.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 10, 2003 (68 FR 58974), FDA
issued an interim final rule to implement section 307 of the
Bioterrorism Act. The prior notice regulations require, beginning on
December 12, 2003, notification to FDA before food (including animal
feed) is imported or offered for import into the United States. This
guidance responds to questions raised about the interim final rule on
prior notice, and it is intended to help the industry better understand
and comply with the regulations.
FDA is issuing the guidance entitled ``Prior Notice of Imported
Food, Questions and Answers'' as a Level 1 guidance. Consistent with
FDA's good guidance practices regulation (21 CFR 10.115), the agency
will accept comment, but it is implementing the guidance document
immediately, in accordance with Sec. 10.115(g)(2), because the agency
has determined that prior public participation is not feasible or
appropriate. FDA is under a strict statutory deadline in which to
implement these regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Two copies of any mailed comments are to be submitted, except
that individuals may submit one copy. Comments are to
[[Page 69958]]
be identified with the docket number found in brackets in the heading
of this document. The guidance and received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www/cfsan.fda.gov/guidance.html.
Dated: December 11, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-31038 Filed 12-12-03; 8:45 am]
BILLING CODE 4160-01-S