[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20955-20956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10556]


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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)


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 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 CPG provides 
written guidance to FDA's and

[[Page 20956]]

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 food imported or offered 
for import into the United States.

DATES: Submit written or electronic comments concerning the CPG at any 
time.

ADDRESSES: Submit written comments on the 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 CPG.
    Submit written requests for single copies of the 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.

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

    In the Federal Register of November 7, 2008 (73 FR 66411), FDA 
announced 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.'' After considering 
the one comment received, FDA revised the CPG, with CBP concurrence, 
where appropriate. The revised CPG provides written guidance to FDA's 
and CBP's staff on enforcement of section 307 of the Bioterrorism Act 
and the agency's implementing regulations, which require prior notice 
for food imported or offered for import into the United States.
    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. 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 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 CPG is available on the Internet at 
http://www.fda.gov/ora under ``Compliance References.''

    Dated: April 29, 2009.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E9-10556 Filed 5-4-09; 4:15 pm]
BILLING CODE 4160-01-S