[Federal Register: May 3, 2004 (Volume 69, Number 85)]
[Rules and Regulations]
[Page 24070-24071]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my04-13]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No. 2004D-0065]
Guidance for Industry: Questions and Answers Regarding the
Interim Final Rule on Prior Notice of Imported Food (Edition 2);
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 revised guidance entitled ``Questions and Answers
Regarding the Interim Final Rule on Prior Notice of Imported Food
(Edition 2).'' The guidance responds to various questions raised about
section 307 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act) and the agency's
implementing regulation, which require the submission to FDA of prior
notice of food, including animal feed, that 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 Office of Regulatory Affairs, Office of Regional Operations, Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or to
the Prior Notice Help Desk at 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, Office of Regional Operations, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 866-521-2297.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 10, 2003 (68 FR 58974), FDA
issued an interim final rule (IFR) to implement section 307 of the
Bioterrorism Act. The prior notice regulation requires the submission
to FDA beginning on December 12, 2003, of prior notice of food,
including animal feed, that is imported or offered for import into the
United States. On December 16, 2003, FDA issued the first edition of a
guidance entitled ``Prior Notice of Imported Food Questions and Answers
(Edition 1).'' This guidance entitled ``Questions and Answers Regarding
the Interim Final Rule on Prior Notice of Imported Food (Edition 2)''
is a revision of the guidance published on December 16, 2003, and
responds to additional questions about the prior notice IFR. It is
intended to help the industry better understand and comply with the
regulation in 21 CFR part 1, subpart I. FDA is issuing this guidance
entitled ``Questions and Answers Regarding the Interim Final Rule on
Prior Notice of Imported Food (Edition 2)'' as a level 1 guidance.
Consistent with FDA's good guidance practices regulation (Sec.
10.115(g)(2) (21 CFR 10.115)(g)(2)), the agency will accept comments,
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. As noted, the
Bioterrorism Act requires prior notice submission to FDA starting on
December 12, 2003. Clarifying the provisions of the IFR will facilitate
timely and accurate prior notice submissions and thus, assist in the
implementation of the IFR. FDA continues to receive a large number of
questions regarding the prior notice IFR, and is responding to these
inquires under Sec. 10.115 as promptly as possible, using a question-
and-answer format. The agency believes that it is reasonable to
maintain all responses to questions concerning prior notice of imported
food in a single document that is periodically updated as the agency
receives and responds to additional
[[Page 24071]]
questions. The following four indicators will be employed to help users
of the guidance identify revisions: (1) The guidance will be identified
as a revision of a previously issued document, (2) the revision date of
the guidance will appear on its cover, (3) the edition number of the
guidance will be included in its title, and (4) questions and answers
that have been revised or added to the original guidance will be
identified as such in the body of the guidance.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one copy. Comments
are to 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: April 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10023 Filed 4-29-04; 11:01 am]
BILLING CODE 4160-01-S