[Federal Register: November 14, 2005 (Volume 70, Number 218)]
[Notices]
[Page 69160-69161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no05-59]
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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
Compliance Policy Guide November 2005
