[Federal Register Volume 79, Number 246 (Tuesday, December 23, 2014)]
[Notices]
[Pages 77011-77012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30015]


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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 Labeling of Processed and 
Blended Seafood Products Made Primarily With Fish Protein; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of Compliance Policy Guide Sec. 540.700 Labeling of 
Processed and Blended Seafood Products Made Primarily with Fish Protein 
(the CPG). The CPG provides guidance for our staff on our labeling 
requirements for processed and blended seafood products made primarily 
with fish protein.

DATES: Submit either electronic or written comments on FDA's CPGs at 
any time.

ADDRESSES: Submit written requests for single copies of the CPG to the 
Office of Policy and Risk Management, Office of Regulatory Affairs, 
Office of Global Regulatory Operations and Policy, Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857. Send one self-
addressed adhesive label to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the CPG.
    Submit electronic comments on the CPG to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT: Catalina Ferre-Hockensmith, Center for 
Food Safety and Applied Nutrition (HFC-820), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of revised Compliance Policy 
Guide Sec. 540.700 Labeling of Processed and Blended Seafood Products 
Made Primarily with Fish Protein. We are issuing the revisions to the 
CPG as Level 2 guidance under our good guidance practices regulation 
(21 CFR 10.115). Consistent with our good guidance practices 
regulation, we will accept comments on the CPG at any time. The CPG 
represents our 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.
    The CPG updates previously issued CPG Sec. 540.700 Processed and/or

[[Page 77012]]

Blended Seafood Products, which provides guidance for our staff on 
labeling requirements for processed and blended seafood products made 
primarily with fish protein. The CPG has been revised for clarity and 
format, including the addition of Regulatory Action Guidance and 
Specimen Charges sections. The CPG contains information that may be 
useful to the regulated industry and to the public.

II. Comments

    Interested persons may submit either written comments regarding the 
guidance to the Division of Dockets Management (see ADDRESSES) or 
electronic comments regarding the guidance to http://www.regulations.gov. It is only necessary to send one set of comments. 
Identify comments 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, 
and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: December 18, 2014.
Melinda K. Plaisir,
Associate Commissioner for Regulatory Affairs, Office of Regulatory 
Affairs.
[FR Doc. 2014-30015 Filed 12-22-14; 8:45 am]
BILLING CODE 4164-01-P