[Federal Register Volume 89, Number 103 (Tuesday, May 28, 2024)]
[Proposed Rules]
[Pages 46042-46043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 80

[Docket No. FDA-2022-N-1635]


Color Additive Certification; Increase in Fees for Certification 
Services; Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the reopening notice entitled ``Color 
Additive Certification; Increase in Fees for Certification Services; 
Reopening of the Comment Period'' that appeared in the Federal Register 
of April 26, 2024. We are taking this action in response to a request 
for an extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period on the notice ``Color 
Additive Certification; Increase in Fees for Certification Services; 
Reopening of the Comment Period'' published in the Federal Register of 
April 26, 2024 (89 FR 32384). Either electronic or written comments 
must be submitted by June 27, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 27, 2024. Comments received 
by mail/hand delivery/courier (for written paper submissions) will be 
considered timely if they are received on or before that date.

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

[[Page 46043]]

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-2022-N-1635 for ``Color Additive Certification; Increase in Fees 
for Certification Services; Extension of the Comment Period.'' 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: Bryan Bowes, Center for Food Safety 
and Applied Nutrition, Office of Cosmetics and Colors (HFS-105), Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1122; or Carrol Bascus, Center for Food Safety and Applied 
Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 2, 2022 
(87 FR 66116), FDA published a proposed rule to amend the color 
additive regulations to increase the fee for certification services. On 
April 26, 2024, we published a notice of reopening entitled ``Color 
Additive Certification; Increase in Fees for Certification Services; 
Reopening of the Comment Period'' (89 FR 32384). We reopened the 
comment period because we added supporting information to the 
administrative record and adjusted the administrative record to reflect 
the same cost and benefits figures that were published in the 
preliminary regulatory impact analysis. This action invited public 
comments on the new information and provided a 30-day comment period.
    FDA received a request for a 90-day extension of the comment period 
for the reopening notice. We are extending the comment period for 30 
days until June 27, 2024. The Agency believes that the extension is 
reasonable and allows adequate time for interested parties to review 
the supporting information added to the administrative record and to 
develop and submit additional comments to the proposed rule.

    Dated: May 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11639 Filed 5-24-24; 8:45 am]
BILLING CODE 4164-01-P