[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Notices]
[Pages 6902-6903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0043] (formerly Docket No. 2004D-0510)


Guidance for Industry: Referral Program From the Food and Drug 
Administration to the National Oceanic and Atmospheric Administration 
Seafood Inspection Program for the Certification of Fish and Fishery 
Products for Export to the European Union and the European Free Trade 
Association; 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 guidance document entitled ``Guidance for 
Industry: Referral Program from the Food and Drug Administration to the 
National Oceanic and Atmospheric Administration Seafood Inspection 
Program for the Certification of Fish and Fishery Products for Export 
to the European Union and the European Free Trade Association.'' The 
revised guidance only changes the date on which FDA intends to stop 
issuing export certificates for fish or fishery products that are to be 
shipped to the European Union (EU) and the European Free Trade 
Association (EFTA). The date FDA now intends to stop issuing EU Export 
Certificates is June 17, 2009.

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Food Safety (HFS-300), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740-3835. Send one self-addressed adhesive label to 
assist that office in processing your request. Submit written comments 
concerning the guidance to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments on the guidance to 
http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: William Jones, Center for Food Safety 
and Applied Nutrition (HFS-325), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 15, 2009 (74 FR 2600) (the 
January 15 notice), FDA announced the availability of a guidance 
entitled ``Referral Program from the Food and Drug Administration to 
the National Oceanic and Atmospheric Administration Seafood Inspection 
Program for the Certification of Fish and Fishery Products for Export 
to the European Union and the European Free Trade Association.'' In the 
January 15 notice, FDA announced that it: (1) Intends to proceed with a 
Certification Referral Program to the National Oceanic and Atmospheric 
Administration Seafood Inspection Program (NOAA SIP), without a 24-
month test period, (2) intends to expand the program to include all 
fish and fishery products for export to the EU and EFTA, and (3) 
intends to stop issuing EU Export Certificates effective February 17, 
2009. The agency stated that it intends to adopt this approach because 
the industry's demand for EU Export Certificates continues to rise 
dramatically, and FDA can no longer justify the use of our limited food 
safety resources for issuance of EU Export Certificates. The 
implementation of this guidance should free up resources that the 
agency can allocate for higher priority public health activities that 
are intended to protect the U.S. consuming public, while still 
providing a mechanism for the industry to continue obtaining EU 
certification. Seafood processors and other entities involved in the 
exporting of seafood to the EU may obtain EU Export Certificates from 
the NOAA SIP.

[[Page 6903]]

    After publication of the January 15 notice, FDA received comments 
and has determined it would be beneficial to have more time to 
deliberate further on the policy issues presented by this action. 
Consequently, FDA is revising the guidance to announce that it intends 
to stop issuing EU Export Certificates on June 17, 2009.
    FDA is issuing this guidance document as a level 2 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115(c)(2)). The guidance represents FDA'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, NOAA SIP, 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 guidance and received comments 
maybe seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.cfsan.fda.gov/guidance.html.

    Dated: February 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2802 Filed 2-6-09; 12:00 pm]
BILLING CODE 4160-01-S