[Federal Register Volume 84, Number 180 (Tuesday, September 17, 2019)]
[Notices]
[Pages 48935-48936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20037]


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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Guidance for Industry; Draft Guidance: Availability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availability of a draft guidance for industry entitled ``Reconditioning 
of Fish and Fishery Products by Segregation.'' The draft guidance, when 
finalized, will 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DATES: Submit either electronic or written comments on the draft 
guidance by November 18, 2019 to ensure that we consider your comment 
on the draft guidance before we begin work on the final version of the 
guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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:
     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.
     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.
     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.gpo.gov/fdsys/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 http://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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).

[[Page 48936]]

    Submit written requests for single copies of the draft guidance to 
the Division of Seafood Safety, 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 draft 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.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Reconditioning of Fish and Fishery Products by 
Segregation.'' We are issuing the draft guidance consistent with our 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of the 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 alternate approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This guidance is not subject to Executive Order 12866.
    The draft 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:
     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
     segregation based on the results of statistically 
significant sampling and testing.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Use the FDA website listed 
in the previous sentence to find the most current version of the 
guidance.

III. Paperwork Reduction Act of 1995

    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. 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 OMB control number 0910-0025.

    Dated: September 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20037 Filed 9-16-19; 8:45 am]
BILLING CODE 4164-01-P


