
[Federal Register: November 7, 2008 (Volume 73, Number 217)]
[Notices]               
[Page 66411]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no08-111]                         



[[Page 66411]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0487] (formerly Docket No. 2007D-0260]

 
Draft Compliance Policy Guide; ``Sec. 110.310 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 draft Compliance Policy Guide (CPG) entitled ``Sec. 
110.310 Prior Notice of Imported Food Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002.'' The draft 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 final rule entitled ``Prior Notice of Imported Food 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002'' is published elsewhere in this issue of the 
Federal Register.

DATES: Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on the 
draft CPG before it begins work on the final version of the CPG, submit 
written or electronic comments concerning the draft CPG by December 8, 
2008.

ADDRESSES: Submit written requests for single copies of the draft CPG 
to the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send two self-addressed adhesive labels to assist that office in 
processing your request, or fax your request to 240-632-6861.
    Submit written comments on the draft CPG 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft CPG.

FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory 
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft CPG entitled ``Sec. 
110.310 Prior Notice of Imported Food Under the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002.'' This guidance 
is issued with CBP concurrence and explains to FDA and CBP staff the 
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 1.276 through 1.285). The final regulation requiring that FDA 
receive prior notice of the importation of food is published elsewhere 
in this issue of the Federal Register and will take effect on May 6, 
2009.
    FDA is issuing this CPG as level 1 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft CPG, when 
finalized, will represent 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. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

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 copies 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 draft CPG and received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    Please not that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

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

    Dated: October 10, 2008.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E8-26281 Filed 10-31-08; 11:15 am]

BILLING CODE 4160-01-S
