[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Rules and Regulations]
[Page 69992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 123

[Docket No. FDA-2013-D-0269]


Guidance for Industry on Purchasing Reef Fish Species Associated 
With the Hazard of Ciguatera Fish Poisoning; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Guidance for 
Industry: Purchasing Reef Fish Species Associated with the Hazard of 
Ciguatera Fish Poisoning.'' The document provides guidance to primary 
seafood processors who purchase reef fish on how to minimize the risk 
of ciguatera fish poisoning (CFP) from fish that they distribute. The 
guidance intends to help protect the public health by reducing the risk 
of CFP.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
Division of Seafood Safety/Office of Food Safety, Center for Food 
Safety and Applied Nutrition, (HFS-325), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Karen Swajian, Division of Seafood 
Safety, Center for Food Safety and Applied Nutrition (HFS-325), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-2300.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Guidance for Industry: Purchasing Reef Fish Species 
Associated with the Hazard of Ciguatera Fish Poisoning.'' This guidance 
is being issued consistent with our good guidance practices regulation 
(21 CFR 10.115). The guidance 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 alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.
    In the Federal Register of March 26, 2013 (78 FR 18273), FDA made 
available a draft guidance entitled ``Guidance for Industry: Purchasing 
Reef Fish Species Associated with the Hazard of Ciguatera Fish 
Poisoning'' and gave interested parties an opportunity to submit 
comments by May 28, 2013, for us to consider before beginning work on 
the final version of the guidance. We received three comments on the 
draft guidance, but the comments did not prompt us to revise the 
guidance. Therefore, we are issuing the guidance with minor changes 
(revising dates mentioned in the guidance to reflect the most current 
information). The guidance announced in this notice finalizes the draft 
guidance dated March 2013.

II. Comments

    Interested persons may submit either electronic comments regarding 
the guidance to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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/FoodGuidances 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: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27913 Filed 11-21-13; 8:45 am]
BILLING CODE 4160-01-P