[Federal Register Volume 70, Number 218 (Monday, November 14, 2005)]
[Notices]
[Pages 69160-69161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22500]


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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; 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 section 307 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 food imported or offered for import into the 
United States. The CPG has been revised to finalize the sections 
pertaining to routine shipments of food that are transshipped through 
the United States, arriving from and exiting to the same country, and 
regarding the Harmonized Tariff Schedule (HTS) code that is part of the 
planned shipment information.

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

ADDRESSES: You may submit comments, identified by Docket No. 2003D-0544 
and/ Regulatory Information Number (RIN) number (if a RIN number has 
been assigned), by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
    <bullet> Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and RIN (if a RIN number has been assigned) for this 
rulemaking. All comments received may be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number(s), found in brackets in the heading of 
this document, into the ``Search'' box and follow the prompts and/or go 
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    Submit written requests for single copies of the revised 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.

FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory 
Affairs (HFC-180), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 4, 2005 (70 FR 10657), FDA 
announced the availability of a draft revision to 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 guidance was 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 (21 CFR parts 1.276 through 1.285). The new 
policies provide additional flexibility in filing prior notice when, 
due to the geography, the only practical transportation route available 
for the shipment is through the United States and when there is a prior 
notice violation because the prior notice does not include the 6-digit 
HTS code for the article of food.
    FDA received 8 comments on the draft sections of the revised CPG. 
FDA reviewed and evaluated these comments and has modified the CPG with 
CBP concurrence, where appropriate.
    FDA is issuing this CPG as level 1 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The CPG represents 
the agency's current thinking on its enforcement policy concerning 
prior notice. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance 
document. 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.

[[Page 69161]]

III. Electronic Access

    An electronic version of the revised CPG is available on the 
Internet at http://www.fda.gov/ora under ``Compliance References.''

    Dated: November 4, 2005.
Steve Niedelman,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 05-22500 Filed 11-10-05; 8:45 am]
BILLING CODE 4160-01-S