[Federal Register: August 16, 2004 (Volume 69, Number 157)]
[Notices]
[Page 50388-50389]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au04-74]
 
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
[Docket No. 2004D-0361]
 
 
Guidance for Industry: Prior Notice of Imported Food Contingency
Plan for System Outages; Availability
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Notice.
 
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a contingency plan that provides guidance on submitting
prior notice of imported food during system outages affecting the
applicable FDA and Customs and Border Protection (CBP) program systems.
Section 307 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act) and its implementing
regulations require prior notice to FDA of all food imported or offered
for import into the United States.
 
DATES: This guidance is final upon the date of publication. However,
you may submit written or electronic comments at any time.
 
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Compliance Policy (HFC-230), Office of Enforcement,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request or include a fax number to which the guidance
may be sent.
    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://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
 
FOR FURTHER INFORMATION CONTACT: Domenic Veneziano, Office of
Regulatory Affairs (HFC-100), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 703-621-7809.
 
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 IFR requires the submission to FDA
of prior notice of food, including animal feed, that is imported or
offered for import into the United States. The prior notice IFR
provides that if a customs broker's or self-filer's system is not
working or if the Automated Broker Interface of the Automated
Commercial System is not working, prior notice must be submitted
through the Prior Notice System Interface (PNSI); and that if PNSI or
the Operational and Administrative System for Import Support is not
operating, prior notice information must be submitted by e-mail or by
fax to FDA.
    We stated in the prior notice IFR that FDA does not plan to exempt
any specific categories of food articles from prior notice if system(s)
are not working, and that FDA and CBP are working together to develop
contingency plans for when the applicable FDA and CBP program systems
are not working (68 FR 58974 at 58997). FDA with concurrence from CBP
is announcing the availability of a contingency plan that provides
guidance on submitting prior notice of imported food during system
outages affecting the applicable FDA and CBP program systems. The
contingency plan identifies seven potential system downtime scenarios
that could impact transmission, confirmation, and processing of prior
notice submissions and explains recommended submission options for each
of the identified scenarios. In any of the scenarios described in the
contingency plan, where the alternate submission options include both
e-mail and fax (telephonic facsimile) transmissions, e-mail
transmission is strongly encouraged as the more efficient means.
    FDA is issuing this document as a level 1 guidance consistent with
FDA's good guidance practices regulation (Sec. 10.115 (21 CFR 10.115)).
The contingency plan is being implemented immediately without prior
public comment, under Sec. 10.115(g)(2), because the agency has
determined that prior public participation is not feasible or
appropriate. Under section 307 of the Bioterrorism Act, the prior
notice requirements were effective December 12, 2003, and FDA and CBP's
systems for processing prior notice submissions are up and running,
making it urgent that the agencies explain how submitters can fulfill
the prior notice requirements in the event of system outages.
 
II. Comments
 
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance
document. Submit two copies of written comments, except that
individuals may submit one
 
[[Page 50389]]
 
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://www.fda.gov/oc/bioterrorism/bioact.html.
 
 
    Dated: August 11, 2004.
John Marzilli,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-18741 Filed 8-12-04; 10:56 am]
 
BILLING CODE 4160-01-S

Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages August 12, 2004