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