[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81785-81786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27843]


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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; 
Draft 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availability of a draft guidance for FDA staff entitled ``Compliance 
Policy Guide Sec. 540.750 Use of The Seafood List to Determine 
Acceptable Seafood Names'' (the draft Compliance Policy Guide (CPG)). 
The draft CPG, when finalized, will provide guidance for FDA staff 
regarding use of The Seafood List to determine whether a seafood name 
is acceptable.

DATES: Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft CPG 
before we begin work on the final version of the CPG, submit either 
electronic or written comments on the draft CPG by January 17, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 http://www.regulations.gov or at the Division of Dockets Management 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

[[Page 81786]]

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 for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft CPG to the 
Food and Feed Policy Staff, Office of Policy and Risk Management, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857. 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 
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 the draft CPG entitled 
``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to 
Determine Acceptable Seafood Names.'' The draft CPG, if finalized, will 
update the previously issued ``CPG Sec. 540.750--Common or Usual Names 
for Seafood in Interstate Commerce.'' The draft CPG is intended to 
provide guidance for FDA staff regarding use of The Seafood List to 
determine whether a seafood name is acceptable. The draft CPG explains 
when we may consider a seafood product to be misbranded under section 
403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343). The 
draft CPG also contains information that may be useful to the regulated 
industry and to the public.
    We are issuing this draft CPG consistent with our good guidance 
practices regulation (21 CFR 10.115). The draft CPG, when finalized, 
will represent 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.

II. Electronic Access

    Persons with access to the Internet may obtain the draft CPG from 
FDA's Office of Regulatory Affairs CPG history page at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed 
in the previous sentence to find the most current version of the 
guidance.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27843 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P