Reconditioning of Fish and Fishery Products by Segregation: Guidance for Industry; Draft Guidance: Availability

Published date17 September 2019
Citation84 FR 48935
Record Number2019-20037
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 84 Issue 180 (Tuesday, September 17, 2019)
[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                Guidance for Industry; Draft Guidance: Availability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.
                -----------------------------------------------------------------------
                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                availability of a draft guidance for industry entitled ``Reconditioning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 The draft guidance, when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                DATES: Submit either electronic or written comments on the draft
                guidance by November 18, 2019 to ensure that we consider your comment
                on the draft guidance before we begin work on the final version of the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
                

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