[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Notices]
[Pages 2600-2601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-785]


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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 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 guidance 
provides information for seafood processors and other entities that are 
interested in obtaining export certificates for fish or fishery 
products that are to be shipped to the European Union (EU) and the 
European Free Trade Association (EFTA). FDA is also announcing that it 
intends to stop issuing EU Export Certificates after February 17, 2009.

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

ADDRESSES: 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. 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance.

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 November 26, 2004 (69 FR 68948) (the 
November 26 notice), FDA announced the availability of a draft guidance 
entitled ``Proposed Referral Program from the Food and Drug 
Administration to the National Oceanic and Atmospheric Administration 
Seafood Inspection Program for the Certification of Live and Perishable 
Fish and Fishery Products for Export to the European Union and the 
European Free Trade Association.'' In the November 26 notice, FDA 
announced that it proposed to operate a Referral Program for a 24-month 
period to test the viability and effectiveness of such an arrangement. 
During this period, EU Export Certificates for shipments of live and 
perishable fish and fishery products destined for the EU, European 
Union Accession Partnership Countries (EUAPC), and EFTA Members would 
have been issued by the National Oceanic and Atmospheric Administration 
Seafood Inspection Program (NOAA SIP) under the Agricultural Marketing 
Act. In addition, FDA indicated that it intended to stop issuing EU 
Export Certificates for live and perishable fish and fishery products 
during this period. FDA sought comment on this referral program, 
including whether it should be expanded beyond live and perishable to 
all shipments of fish and fishery products destined for the EU, EU 
Accession Partnership Countries, and other countries with certificate 
requirements.
    Interested persons were initially given until December 27, 2004, to 
comment on the draft guidance. The comment period was subsequently 
extended until January 25, 2005 (69 FR 78038, December 29, 2004). The 
agency considered and modified the guidance as appropriate.
    The agency is announcing the availability of the final guidance 
document entitled ``Guidance for Industry: Referral Program from the 
Food and Drug Administration to the National Oceanic and Atmosphere 
Administration Seafood Inspection Program for the Certification of Fish 
and Fishery Products for the Export to the European Union and the 
European Free

[[Page 2601]]

Trade Association.'' In this final guidance, FDA is announcing that: 
(1) We intend to proceed with a Certification Referral Program to NOAA 
SIP, without a 24-month test period, (2) we intend to expand the 
program to include all fish and fishery products for export to the EU 
and EFTA, and (3) we intend to stop issuing EU Export Certificates 
effective February 17, 2009. The agency 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.
    FDA is issuing this guidance document as a level 1 guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). This 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 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 guidance 
document at http://www.cfsan.fda.gov/guidance.html.

    Dated: January 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-785 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-01-S