[Federal Register Volume 85, Number 244 (Friday, December 18, 2020)]
[Proposed Rules]
[Pages 82393-82395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0053]
RIN 0910-AI44


Requirements for Additional Traceability Records for Certain 
Foods; Extension of Comment Period; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period; reopening of the 
comment period.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
extending the comment period for the proposed rule and reopening the 
comment period for the information collection related to the proposed 
rule entitled ``Requirements for Additional Traceability Records for 
Certain Foods'' that appeared in the Federal Register of September 23, 
2020. We are taking this action in response to a request from 
stakeholders to extend the comment period to allow additional time for 
interested persons to submit comments on the proposed rule. We also are 
taking this action to keep the comment period for the information 
collection provisions associated with the rule consistent with the 
comment period for the proposed rule.

DATES: FDA is extending the comment period on the proposed rule 
published September 23, 2020 (85 FR 59984). Submit either electronic or 
written comments on the proposed rule by February 22, 2021. Submit 
comments on information collection issues under the Paperwork Reduction 
Act of 1995 (PRA) by February 22, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,

[[Page 82394]]

untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 22, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.
    To ensure that comments on the information collection are received, 
OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0560. Also include the FDA docket 
number found in brackets in the heading of this document.

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-2014-N-0053 for ``Requirements for Additional Traceability Records 
for Certain Foods.'' Received comments, those filed in a timely manner 
(see ADDRESSES), 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.'' 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 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: 
    Regarding the proposed rule: Brian Pendleton, Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-4614, [email protected].
    Regarding the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION:  In the Federal Register of September 23, 
2020 (85 FR 59984), we published a proposed rule entitled 
``Requirements for Additional Traceability Records for Certain Foods'' 
with a 120-day comment period on the provisions of the proposed rule 
and a 60-day comment period on the information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
    FDA has received a request for a 60-day extension of the comment 
period for the provisions of the proposed rule and an extension of the 
comment period for the information collection provisions to align with 
the end of the comment period for the provisions of the proposed rule. 
The request conveyed concern that the current 120-day comment period 
does not allow stakeholders time to thoroughly analyze the rule due to 
its complexity and competing priorities. The request also noted that 
stakeholders cannot provide meaningful feedback on the information 
collection burden of the proposed rule without first having given the 
entire proposed rule thorough consideration, and therefore asked that 
the comment period for the information collection provisions be 
extended to align with the comment period for the provisions of the 
proposed rule. We have concluded that it is reasonable to extend for 30 
days the comment period for the provisions of the proposed rule. The 
Agency believes that this extension allows adequate time for any 
interested persons to submit comments on the proposed rule. We also are 
extending the comment period for the information collection provisions 
to February 22, 2021, to align the comment period for the information 
collection provisions with the comment period for the provisions of the 
proposed rule.


[[Page 82395]]


    Dated: December 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
    Dated: December 11, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-27829 Filed 12-17-20; 8:45 am]
BILLING CODE 4164-01-P