Reconditioning of Fish and Fishery Products by Segregation: Guidance for Industry; Draft Guidance: Availability, 48935-48936 [2019-20037]

Download as PDF 48935 Federal Register / Vol. 84, No. 180 / Tuesday, September 17, 2019 / Notices ANNUAL BURDEN ESTIMATES—Continued Average burden hours per response Total burden hours Implementation interview protocol: Center director .......................................................................................... Additional center staff ............................................................................... Electronic cost workbook ................................................................................. Staff rosters for time use survey ..................................................................... Time-use survey .............................................................................................. Classroom rosters for observations ................................................................. 80 20 80 80 1,120 80 1 1 1 1 1 1 3 3 8 .25 .25 .50 240 60 640 20 280 40 Total Burden ............................................................................................. ........................ ........................ ........................ 1,619 Authority: Social Security Act § 418 as extended by the Continuing Appropriations Act of 2017 and the TANF Extension Act of 2019. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–20115 Filed 9–16–19; 8:45 am] BILLING CODE 4184–23–P 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[Docket No. FDA–2019–D–3324] Reconditioning of Fish and Fishery Products by Segregation: Guidance for Industry; Draft Guidance: Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ‘‘Reconditioning of Fish and Fishery Products by Segregation.’’ The draft guidance, when finalized, will provide industry with an explanation of two potential approaches to recondition fish and fishery products by effectively segregating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 DATES: Submit either electronic or written comments on the draft guidance by November 18, 2019 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.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: SUMMARY: jbell on DSK3GLQ082PROD with NOTICES Number of responses per respondent Number of respondents Instrument 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 Electronic Submissions be placed in the docket and, except for those submitted as ‘‘Confidential Submit electronic comments in the Submissions,’’ publicly viewable at following way: • Federal eRulemaking Portal: https:// https://www.regulations.gov or at the Dockets Management Staff between 9 www.regulations.gov. Follow the VerDate Sep<11>2014 17:05 Sep 16, 2019 Jkt 247001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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/201523389.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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). E:\FR\FM\17SEN1.SGM 17SEN1 48936 Federal Register / Vol. 84, No. 180 / Tuesday, September 17, 2019 / Notices 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 selfaddressed 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: jbell on DSK3GLQ082PROD with NOTICES 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 productionrelated 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/Regulatory Information/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. VerDate Sep<11>2014 17:05 Sep 16, 2019 Jkt 247001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific guidances available to the public on FDA’s website. The guidances identified in this notice were developed using the process described in that guidance. DATES: Submit either electronic or written comments on the draft guidances by November 18, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: 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, PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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– 2007–D–0369 for ‘‘Product-Specific Guidances; Draft and Revised Draft Guidances for Industry.’’ 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.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available E:\FR\FM\17SEN1.SGM 17SEN1

Agencies

[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]


-----------------------------------------------------------------------

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 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.
    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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.