From: Subject: FR Doc E8-26281 Date: Tue, 11 Nov 2008 09:10:50 -0500 MIME-Version: 1.0 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://edocket.access.gpo.gov/2008/E8-26281.htm X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 FR Doc E8-26281 
[Federal Register: November 7, 2008 (Volume 73, Number =
217)]
[Notices]              =20
[Page 66411]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no08-111]                        =20



[[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]

=20
Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of=20
Imported Food Under the Public Health Security and Bioterrorism=20
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=20
availability of a draft Compliance Policy Guide (CPG) entitled ``Sec.=20
110.310 Prior Notice of Imported Food Under the Public Health Security=20
and Bioterrorism Preparedness and Response Act of 2002.'' The draft CPG=20
provides written guidance to FDA's and Customs and Border Protection's=20
(CBP's) staff on enforcement of section 307 of the Public Health=20
Security and Bioterrorism Preparedness and Response Act of 2002 (the=20
Bioterrorism Act) and the agency's implementing regulations, which=20
require prior notice for food imported or offered for import into the=20
United States. The final rule entitled ``Prior Notice of Imported Food=20
Under the Public Health Security and Bioterrorism Preparedness and=20
Response Act of 2002'' is published elsewhere in this issue of the=20
Federal Register.

DATES: Although you can comment on any CPG at any time (see 21 CFR=20
10.115(g)(5)), to ensure that the agency considers your comment on the=20
draft CPG before it begins work on the final version of the CPG, submit=20
written or electronic comments concerning the draft CPG by December 8,=20
2008.

ADDRESSES: Submit written requests for single copies of the draft CPG=20
to the Division of Compliance Policy (HFC-230), Office of Enforcement,=20
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.=20
Send two self-addressed adhesive labels to assist that office in=20
processing your request, or fax your request to 240-632-6861.
    Submit written comments on the draft CPG to the Division of Dockets=20
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,=20
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://fr=
webgate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3D=
linklog&to=3Dhttp://www.regulations.gov. See the SUPPLEMENTARY =
INFORMATION section for=20
electronic access to the draft CPG.

FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory=20
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane,=20
Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft CPG entitled ``Sec.=20
110.310 Prior Notice of Imported Food Under the Public Health Security=20
and Bioterrorism Preparedness and Response Act of 2002.'' This guidance=20
is issued with CBP concurrence and explains to FDA and CBP staff the=20
FDA and CBP policies on enforcement of section 307 of the Bioterrorism=20
Act and its implementing regulations, which require prior notice to FDA=20
of all food imported or offered for import into the United States (21=20
CFR 1.276 through 1.285). The final regulation requiring that FDA=20
receive prior notice of the importation of food is published elsewhere=20
in this issue of the Federal Register and will take effect on May 6,=20
2009.
    FDA is issuing this CPG as level 1 guidance consistent with FDA's=20
good guidance practices regulation (21 CFR 10.115). The draft CPG, when=20
finalized, will represent the agency's current thinking on its=20
enforcement policy concerning prior notice. It does not create or=20
confer any rights for or on any person and does not operate to bind=20
FDA, or the public. An alternative approach may be used if such=20
approach satisfies the requirements of the applicable statutes and=20
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management=20
(see ADDRESSES) written or electronic comments regarding this document.=20
Submit a single copy of electronic copies or two paper copies of any=20
mailed comments, except that individuals may submit one paper copy.=20
Comments are to be identified with the docket number found in brackets=20
in the heading of this document. The draft CPG and received comments=20
may be seen in the Division of Dockets Management between 9 a.m. and 4=20
p.m., Monday through Friday.
    Please not that on January 15, 2008, the FDA Division of Dockets=20
Management Web site transitioned to the Federal Dockets Management=20
System (FDMS). FDMS is a Government-wide, electronic docket management=20
system. Electronic comments or submissions will be accepted by FDA only=20
through FDMS at http://fr=
webgate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3D=
linklog&to=3Dhttp://www.regulations.gov.

III. Electronic Access

    An electronic version of the draft CPG is available on the Internet=20
at http://frwebg=
ate.access.gpo.gov/cgi-bin/leaving.cgi?from=3DleavingFR.html&log=3Dli=
nklog&to=3Dhttp://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]

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