Document ID: FDA-2004-D-0043-0011
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Referral Program from the FDA to the NOAA Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association
Posted Date: 2009-02-11T05:00Z

[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6902-6903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe09-61]

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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