[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Proposed Rules]
[Pages 19026-19027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06579]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 74
[Docket No. FDA-2023-N-0437]
Filing of Color Additive Petition From Center for Science in the
Public Interest, et al.; Request To Revoke Color Additive Listing for
Use of FD&C Red No. 3 in Food and Ingested Drugs; Extension of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Petition for rulemaking; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the color additive petition for which we published a
notice of filing in the Federal Register of February 17, 2023. In the
notice, FDA requested comments on a filed color additive petition
submitted by Center for Science in the Public Interest, et al.,
proposing that FDA repeal the color additive regulations providing for
the use of FD&C Red No. 3 in foods (including dietary supplements) and
in ingested drugs. 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 color additive
petition for which a notice of filing was published in the Federal
Register of February 17, 2023 (88 FR 10245). Either electronic or
written comments must be submitted by May 18, 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 on May 18, 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
[[Page 19027]]
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-2023-N-0437 for ``Filing of Color Additive Petition from Center for
Science in the Public Interest, et al.; Request to Revoke Color
Additive Listing for Use of FD&C Red No. 3 in Food and Ingested
Drugs.'' 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 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: Shayla West-Barnette, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1262.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 17, 2023
(88 FR 10245), we published a notice of filing of a color additive
petition with a 60-day comment period. We explained that, under section
721(d)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 379e(d)(1)), we were giving notice that we had filed a color
additive petition (CAP 3C0323), submitted by Center for Science in the
Public Interest, Breast Cancer Prevention Partners, Center for
Environmental Health, Center for Food Safety, Chef Ann Foundation,
Children's Advocacy Institute, Consumer Federation of America, Consumer
Reports, Defend Our Health, Environmental Defense Fund, Environmental
Working Group, Feingold Association of the United States, Food & Water
Watch, Healthy Babies Bright Futures, Life Time Foundation, Momsrising,
Prevention Institute, Public Citizen, Public Health Institute, Public
Interest Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S.
Birnbaum, and Philip J. Landrigan, c/o Jensen Jose, 1250 I Street NW,
Suite 500, Washington, DC 20005. The color additive petition proposes
that we repeal the color additive regulations for FD&C Red No. 3 in 21
CFR 74.303, which permits the use of FD&C Red No. 3 in foods (including
dietary supplements), and 21 CFR 74.1303, which permits the use of FD&C
Red No. 3 in ingested drugs.
We have received a request for a 60-day extension of the comment
period for the color additive petition The request conveyed concern
that the current 60-day comment period does not allow sufficient time
to develop a thoughtful response to the color additive petition.
FDA has considered the request and is extending the comment period
for the color additive petition until May 18, 2023. We believe that a
30-day extension allows adequate time for interested persons to submit
comments without significantly delaying a response to this petition.
We also clarify a statement in the notice of filing. In describing
the petitioners' claim that the action they sought in their petition is
categorically excluded under our environmental regulations at Sec.
25.32 (21 CFR 25.32), we referred only to a categorical exclusion for
food packaging (88 FR 10245 at 10246). The regulation we cited, Sec.
25.32(m), categorically excludes an action to prohibit or otherwise
restrict or reduce the use of a substance in food, food packaging, or
cosmetics.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06579 Filed 3-29-23; 8:45 am]
BILLING CODE 4164-01-P