[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42412-42413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3004]


Use of The Seafood List To Determine Acceptable Seafood Names; 
Compliance Policy Guide; 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 final guidance for FDA staff entitled ``Compliance 
Policy Guide Sec. 540.750

[[Page 42413]]

Use of The Seafood List to Determine Acceptable Seafood Names'' (the 
CPG). The CPG provides guidance for FDA staff regarding use of The 
Seafood List to determine whether a seafood name is acceptable.

DATES: The announcement of the guidance is published in the Federal 
Register on July 14, 2020.

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances 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-2016-D-3004 for ``Compliance Policy Guide Sec. 540.750 Use of The 
Seafood List to Determine Acceptable Seafood Names.'' 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.
     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 (21 CFR 
10.115(g)(5).
    Submit written requests for single copies of the CPG to the Office 
of Strategic Planning and Operational Policy, Office of Regulatory 
Affairs, Food and Drug Administration, Bldg. 32, Rm. 4337, 10903 New 
Hampshire Ave., Silver Spring, MD 20993. Send two self-addressed 
adhesive labels to assist that office in processing your request. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the CPG.

FOR FURTHER INFORMATION CONTACT: Spring C. Randolph, Center for Food 
Safety and Applied Nutrition (HFC-325), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1421.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for FDA staff 
entitled ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List 
to Determine Acceptable Seafood Names.'' The CPG updates the previously 
issued ``CPG Sec. 540-750--Common or Usual Names for Seafood in 
Interstate Commerce.'' We are issuing this CPG consistent with our good 
guidance practices regulation (21 CFR 10.115). The CPG represents our 
current thinking on acceptable names for seafood in interstate 
commerce. 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.
    In the Federal Register of November 18, 2016 (81 FR 81785), we made 
available a draft CPG entitled ``Compliance Policy Guide Sec. 540.750 
Use of The Seafood List to Determine Acceptable Seafood Names'' and 
gave interested parties an opportunity to submit comments by January 
17, 2017, for us to consider before beginning work on the final version 
of the guidance. We received no comments on the draft guidance. 
However, we made editorial changes. The editorial changes include 
adding ``vernacular name'' to the categories of names found in The 
Seafood List and revising the term ``Districts'' to ``Field Offices'' 
to reflect an FDA organizational change. The CPG announced in this 
notice finalizes the draft CPG dated November 2016.

II. Electronic Access

    Persons with access to the internet may obtain the CPG from FDA's 
Office of Regulatory Affairs CPG history page at https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/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.

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15146 Filed 7-13-20; 8:45 am]
BILLING CODE 4164-01-P


