[Federal Register Volume 73, Number 228 (Tuesday, November 25, 2008)]
[Notices]
[Page 71655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0588]


Compliance Policy Guide Sec. 540.700 Processed and/or Blended 
Seafood Products (CPG 7108.16); 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 revised Compliance Policy Guide Sec. 540.700 Processed 
and/or Blended Seafood Products (CPG 7108.16) (the CPG). The CPG 
provides guidance for FDA staff on FDA's labeling requirements for 
processed and blended seafood products.

DATES: Submit written or electronic comments regarding 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. 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. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the CPG.

FOR FURTHER INFORMATION CONTACT: Catalina Ferre-Hockensmith, Center for 
Food Safety and Applied Nutrition (HFS-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 26, 1985 (50 FR 30523), FDA made 
available Compliance Policy Guide 7108.16, which was subsequently 
renumbered and renamed Compliance Policy Guide Sec. 540.700 Processed 
and/or Blended Seafood Products (CPG 7108.16). FDA has revised the CPG. 
The CPG provides guidance for FDA staff on FDA's labeling requirements 
for processed and blended seafood products. The CPG also contains 
information that may be useful to the regulated industry and to the 
public.
    FDA is issuing the revisions to the CPG as Level 2 guidance under 
FDA's good guidance practices regulation (21 CFR 10.115). Consistent 
with FDA's good guidance practices regulation, the agency will accept 
comments on the CPG at any time. The CPG represents the agency's 
current thinking on this topic. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternate 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 the 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note 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

    Persons with access to the Internet may obtain the CPG from FDA's 
Office of Regulatory Affairs history page. It may be accessed at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg540-700.html.

    Dated: November 14, 2008.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E8-27969 Filed 11-24-08; 8:45 am]
BILLING CODE 4160-01-S