Proposed Rule2023-01361
Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 24, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 15 (Tuesday, January 24, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
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