[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22221-22222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3324]


Reconditioning of Fish and Fishery Products by Segregation; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Reconditioning of Fish and Fishery Products by Segregation.'' This 
guidance is intended to provide industry with an explanation of two 
potential approaches to recondition fish and fishery products by 
effectively segregating adulterated portions of an article from 
portions not containing the adulterant to ensure that only safe and 
wholesome product reaches consumers.

DATES: The announcement of the guidance is published in the Federal 
Register on April 14, 2022.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-3324 for ``Reconditioning of Fish and Fishery Products by 
Segregation.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to Office 
of Food Safety, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5001 Campus Dr., 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.

FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Division of Seafood 
Safety, Office of Food Safety, Center for Food Safety and Applied 
Nutrition (HFS-325), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-5316; or Lauren Kleinman, Office of 
Regulations and Policy (HFS-024), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Reconditioning of Fish and Fishery Products by 
Segregation.'' We are issuing the guidance consistent with our

[[Page 22222]]

good guidance practices regulation (21 CFR 10.115). The guidance 
represents the current thinking of FDA on this topic. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    This guidance is intended to help owners of fish and fishery 
products, or their representatives, interested in bringing adulterated 
products into compliance with the Federal Food, Drug, and Cosmetic Act 
by means of segregating non-violative product from adulterated product. 
Specifically, this document provides guidance on:
    <bullet> Segregation based on a production-related rationale 
supported by production records or information identifying the cause of 
the adulteration along with sampling and testing to confirm that the 
segregation was successful; or
    <bullet> Segregation based on the results of statistically 
significant sampling and testing.
    In the Federal Register of September 17, 2019 (84 FR 48935), we 
announced a draft guidance for industry entitled ``Reconditioning of 
Fish and Fishery Products by Segregation'' and gave interested parties 
an opportunity to submit comments by November 18, 2019, for us to 
consider before beginning work on the final version of the guidance. We 
received comments on the draft guidance and have modified the final 
guidance where appropriate. Changes to the guidance include the 
addition of a detailed explanation for our more robust sampling 
recommendations. The guidance announced in this notice finalizes the 
draft guidance dated September 2019.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR 1.94(b) and 21 CFR 1.95(a) and (b) using Form 
FDA 766 have been approved under the OMB control number 0910-0025.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: April 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07979 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P