[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Proposed Rules]
[Pages 4117-4118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 80

[Docket No. FDA-2022-N-1635]
RIN 0910-AI69


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the proposed rule, ``Color Additive Certification; 
Increase in Fees for Certification Services,'' which published in the 
Federal Register of November 2, 2022. We are taking this action in 
response to a request from stakeholders to extend the comment period to 
allow additional time for interested parties to collect, analyze, and 
incorporate data to develop comments for this proposed rule.

DATES: FDA is reopening the comment period on the proposed rule ``Color 
Additive Certification; Increase in Fees for Certification Services,'' 
which published in the Federal Register on November 2, 2022 (87 FR 
66116). Either electronic or written comments must be submitted by 
March 10, 2023.

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 March 10, 2023. 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 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; Reopening 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.'' 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

[[Page 4118]]

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, Office of Cosmetics and 
Colors (HFS-105), Center for Food Safety and Applied Nutrition, 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. 
The change in fees would allow FDA to continue to maintain an adequate 
color certification program as required by the Federal Food, Drug, and 
Cosmetic Act. The fees are intended to recover the full costs of 
operation of FDA's color certification program. We originally gave 
interested persons until January 3, 2023, to provide comments on the 
proposed rule.
    Following publication of the proposed rule, FDA received a request 
to allow interested persons additional time to comment. The request 
asserted that 60 days was insufficient to respond fully to FDA's 
specific requests for comments and to allow potential respondents to 
thoroughly evaluate and address pertinent issues and requested that FDA 
extend the comment period by an additional 30 days. We have considered 
this request and, because it is too late for us to extend the comment 
period before it expired, we are reopening the comment period for 45 
days. We believe that this additional 45 days will allow time for 
interested parties to collect, analyze, and incorporate data and submit 
comments to the proposed rule.

    Dated: January 19, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01361 Filed 1-23-23; 8:45 am]
BILLING CODE 4164-01-P


