[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84347-84348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0530]


Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for 
Industry; Availability; Agency Information Collection Activities; 
Proposed Collection; Comment Request; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the draft guidance entitled ``Voluntary Disclosure 
of Sesame as an Allergen: Draft Guidance for Industry,'' which was 
announced in the Federal Register of November 12, 2020. We are taking 
this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the draft guidance 
published November 12, 2020 (85 FR 71920). Submit either electronic or 
written comments on the draft guidance by February 25, 2021, to ensure 
that we consider your comment on the draft guidance before we begin 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-2020-D-0530 for ``Voluntary Disclosure of Sesame as an Allergen: 
Draft Guidance for Industry; Availability; Agency Information 
Collection Activities; Proposed Collection; Comment Request.'' 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.

FOR FURTHER INFORMATION CONTACT: Carol D'lima, Office of Nutrition and 
Food Labeling, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2371.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 12, 2020 
(85 FR 71920), we published a notice of availability for a draft 
guidance entitled

[[Page 84348]]

``Voluntary Disclosure of Sesame as an Allergen: Draft Guidance for 
Industry; Availability; Agency Information Collection Activities; 
Proposed Collection; Comment Request.'' This action opened a docket 
with a 60-day comment period to receive comments related to the 
voluntary disclosure of sesame as an allergen.
    We have received a request for a 60-day extension of the comment 
period for the draft guidance. The request conveyed concern that the 
current 60-day comment period does not allow sufficient time to develop 
a meaningful response to the draft guidance. In the interest of 
balancing the public health importance of sesame allergen labeling and 
granting additional time to submit comments before we finalize the 
draft guidance, we have concluded that it is reasonable to extend the 
comment period for 45 days, until February 25, 2021. We believe that 
this extension allows adequate time for interested persons to submit 
comments.

    Dated: December 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28559 Filed 12-23-20; 8:45 am]
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