[Federal Register Volume 74, Number 13 (Thursday, January 22, 2009)]
[Notices]
[Pages 4039-4040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0264]


Compliance Policy Guide Sec. 540.370--Fish and Fishery Products--
Decomposition; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the

[[Page 4040]]

availability of Compliance Policy Guide Sec. 540.370--Fish and Fishery 
Products--Decomposition (the CPG). The CPG provides guidance for FDA 
staff on decomposition in fish and fishery products.

DATES:  Submit written or electronic comments on 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: Robert D. Samuels, Center for Food 
Safety and Applied Nutrition (HFS-325), Food and Drug Administration, 
100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 18, 2008 (73 FR 41361), FDA 
announced the availability of draft CPG Sec. 540.370--Fish and Fishery 
Products--Decomposition and gave interested parties an opportunity to 
submit comments. The agency received no comments on the draft CPG but 
on its own initiative made a few editorial changes for clarification 
purposes. The CPG provides guidance for FDA staff on decomposition in 
fish and fishery products. The CPG also contains information that may 
be useful to the regulated industry and to the public.
    FDA is issuing this CPG as a level 1 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The CPG represents 
the agency's current thinking on FDA's direct reference enforcement 
criteria related to decomposition in fish and fishery products. 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 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 CPG and 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 at http://www.fda.gov/ora/compliance_ref/cpg/default.htm.

    Dated: January 12, 2009.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. E9-1142 Filed 1-21-09; 8:45 am]
BILLING CODE 4160-01-S