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                    Document headings vary by document type but may contain                    the following:                  
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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. 2003D-0554]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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:
      - 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:
      - FAX: 301-827-6870.
      - 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.                
      ( print 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