[Federal Register: August 16, 2004 (Volume 69, Number 157)]
[Notices]               
[Page 50389-50390]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au04-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0554]

 
Revised Compliance Policy Guide Regarding Prior Notice of 
Imported Food Under the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002; Revised Joint Food and Drug 
Administration-Customs and Border Protection Plan for Increasing 
Integration and Assessing the Coordination of Prior Notice Timeframes; 
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 revised compliance policy guide (CPG) Sec. 110.310 
entitled ``Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.'' The 
CPG provides written guidance to FDA's and Customs and Border 
Protection's (CBP's) staff on enforcement of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (the 
Bioterrorism Act) and the agency's implementing regulations, which 
require prior notice for all food imported or offered for import into 
the United States. This document also describes certain date changes to 
the Joint Food and Drug Administration-Customs and Border Protection 
Plan for Increasing Integration and Assessing the Coordination of Prior 
Notice Timeframes (revised joint plan) that was announced in the 
Federal Register of April 14, 2004 (69 FR 19765).

DATES: The revised CPG and the revised joint plan are final upon the 
date of publication. However, you may submit written or electronic 
comments on the revised CPG at any time.

ADDRESSES: Submit written requests for single copies of the revised CPG 
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 revised 
CPG may be sent. Submit written comments on the revised CPG to the 
Division of Dockets Management, 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
.

    Submit written requests for single copies of the revised joint plan 
to the Office of Regional Operations (HFC-100), 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 it may be sent.
    See the SUPPLEMENTARY INFORMATION section for electronic access to 
the revised CPG and the revised joint plan.

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

A. Revisions to the CPG

    FDA is announcing the availability of revised CPG Sec. 110.310 
entitled ``Prior Notice of Imported Food Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.'' This 
revised CPG is issued with CBP concurrence and explains to FDA and CBP 
staff the new FDA and CBP policies on enforcement of section 307 of the 
Bioterrorism Act and its implementing regulations, which require prior 
notice to FDA of all food imported or offered for import into the 
United States (68 FR 58974, October 10, 2003), (codified at 21 CFR 
1.276 through 1.285)). The original CPG was issued in December 2003 and 
was revised in June 2004 to include additional guidance regarding food 
imported or offered for import for noncommercial purposes with a 
noncommercial shipper. Since the prior notice interim final rule (IFR) 
became effective in December 2003, FDA and CBP have been reviewing the 
data quality of prior notice submissions. This review has revealed 
practical implementation problems with certain data elements, such as 
registration number, bill of lading number, and ultimate consignee. In 
part, these problems result from a lack of standardization. The 
problems also arose due to the practical difficulties faced by 
submitters in obtaining required information in complex commercial 
settings. Therefore, the CPG is being revised concerning the following 
violations:
     The registration number submitted for the manufacturing 
facility is inaccurate or is invalid;
     The registration number for the shipper is not provided;
     The airway bill number or bill of lading number is not 
provided or is invalid; and
     The name and address of the ultimate consignee is 
inaccurate because it contains the name and address of the express 
consignment operator or consolidator instead of the ultimate consignee.
    For the violations listed previously in this document, FDA and CBP 
should typically consider not taking any regulatory action until 
November 1, 2004.\1\ If, however, the violation reflects a history of 
repeated conduct of a similar nature by a person who had been notified 
of such violations, then the action FDA and CBP staff typically should 
consider taking is assessment of CBP Civil Monetary Penalties.
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    \1\ In the original CPG issued in December 2003, the transition 
period was to end August 12, 2004; CBP and FDA informally referred 
to this time period as ``Phase IV.'' The two agencies now will refer 
to the time period of August 13, 2004, until November 1, 2004, as 
``Phase IV (revised)'' and the time period on or after November 1, 
2004, as ``Phase V.''
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    Another change relates to food imported or offered for import for 
quality assurance, research or analysis purposes only, not for human or 
animal consumption and not for resale. If prior notice does not include 
a required manufacturing facility registration number, FDA and CBP 
should typically not take any regulatory action.
    FDA is issuing this revised CPG as level 1 guidance consistent with 
FDA's good guidance practices regulation (Sec.  10.115 (21 CFR 
10.115)). The revised CPG Sec. 110.310 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. This document revises policies that were due to take 
effect on August 13, 2004, so it is urgent that the

[[Page 50390]]

agencies explain their new enforcement policies before that date.

B. Revisions to the Joint FDA-CBP Plan for Increasing Integration and 
Assessing the Coordination of Prior Notice Timeframes

    On April 14, 2004, FDA and CBP (we) announced the availability of a 
joint plan entitled ``Joint FDA-CBP Plan for Increasing Integration and 
Assessing the Coordination of Prior Notice Timeframes.'' The joint plan 
describes the process by which FDA and CBP intend to increase 
integration and examine whether we could amend the timeframe 
requirements in FDA's prior notice IFR to have the same advanced notice 
timeframes for arrivals by land via road or rail or arrival via air 
that are currently in CBP's advance electronic information rule (69 FR 
19765). Due to the revisions in the CPG described previously that 
extend the transition period of the prior notice IFR to November 1, 
2004, certain dates outlined in the joint FDA-CBP are revised as 
follows:
     We intend to implement the plan in November 2004.
     From November 1, 2004, to January 3, 2005, we plan to 
assess existing procedures and staffing needed to receive, review, and 
respond to the prior notices submitted in accordance with the prior 
notice IFR (i.e., 2 hours before arrival by land by road; 4 hours 
before arrival by air or by land by rail; and 8 hours before arrival by 
water).
     From January 4, 2005, to February 3, 2005, we intend to 
identify what changes to work practices and staffing would be necessary 
to determine if FDA could continue to receive, review, and respond to 
all prior notice submissions with reduced timeframes (e.g., 1 hour or 
30 minutes before arrival by land by road; 2 hours before arrival by 
land by rail; and by ``wheels up'' for flights originating in North and 
Central America, South America (north of the Equator only), the 
Caribbean, and Bermuda; otherwise 4 hours before arrival by air).
     From February 4, 2005, to May 3, 2005, we plan to 
implement necessary changes and make appropriate adjustments to ensure 
we could receive, review, and respond to all prior notice submissions 
with reduced timeframes.
     In June 2005, we intend to issue a prior notice final rule 
that responds to the comments we received on the prior notice IFR, 
including this revised joint plan, during the two open comment periods.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the revised CPG. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The revised CPG 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

    An electronic version of the revised CPG is available on the 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora under ``Compliance Reference.'' An 

electronic version of the revised joint plan is available on the 
Internet 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. 04-18742 Filed 8-12-04; 10:56 am]

BILLING CODE 4160-01-S