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, 19026-19027 [2023-06579]

Download as PDF lotter on DSK11XQN23PROD with PROPOSALS1 19026 Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Proposed Rules may be supplemented by documentary submissions as described below. Transcripts of the oral statements will be placed in the rulemaking record. Interested persons who timely request to make an oral statement will be provided with instructions as to how to participate in the virtual hearing. Requesters who need assistance should indicate as much in their comment, and the Commission will endeavor to provide accommodations. Requesters without the computer technology necessary to participate in video conferencing will be able to participate in the informal hearing by telephone; they should indicate as much in their comments. You can also file a documentary submission online. For the Commission to consider your documentary submission, you must file it on or before April 14, 2023. Write ‘‘Impersonation Informal Hearing, R207000’’ on your submission. Your documentary submission—including your name and your state—will be placed on the public record of this proceeding, including on the website https:// www.regulations.gov. To ensure that the Commission considers your online documentary submission, please follow the instructions on the web-based form. Because your documentary submission will be placed on the public record, you are solely responsible for making sure that it does not include any sensitive or confidential information. In particular, your documentary submission should not contain sensitive personal information, such as your or anyone else’s Social Security number; date of birth; driver’s license number or other state identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your documentary submission does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your documentary submission should not include any ‘‘[t]rade secret or any commercial or financial information which . . . is privileged or confidential’’—as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including, in particular, competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. Documentary submissions containing material for which confidential treatment is requested must be filed in VerDate Sep<11>2014 16:50 Mar 29, 2023 Jkt 259001 paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with Commission Rule 4.9(c), 16 CFR 4.9(c). In particular, the written request for confidential treatment that accompanies the documentary submission must include the factual and legal basis for the request and must identify the specific portions to be withheld from the public record. See Commission Rule 4.9(c). Your documentary submission will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your documentary submission has been posted publicly at https://www.regulations.gov—as legally required by Commission Rule 4.9(b), 16 CFR 4.9(b)—we cannot redact or remove it, unless you submit a confidentiality request that meets the requirements for such treatment under Commission Rule 4.9(c), and the General Counsel grants that request. Visit the FTC website to read this document and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of documentary submissions to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive documentary submissions it receives on or before April 14. For information on the Commission’s privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/ siteinformation/privacypolicy. IV. Communications by Outside Parties to the Commissioners or Their Advisors Under Commission Rule 1.18(c)(1), 16 CFR 1.18(c)(1), the Commission has determined that communications with respect to the merits of this proceeding from any outside party to any Commissioner or Commissioner advisor will be subject to the following treatment: Written communications and summaries or transcripts of all oral communications must be placed in the rulemaking record. Unless the outside party making an oral communication is a Member of Congress, communications received after the close of the publiccomment period are permitted only if advance notice is published in the Weekly Calendar and Notice of ‘‘Sunshine’’ Meetings. By direction of the Commission. April J. Tabor, Secretary. [FR Doc. 2023–06537 Filed 3–29–23; 8:45 am] BILLING CODE 6750–01–P PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 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. Petition for rulemaking; extension of comment period. ACTION: 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. SUMMARY: 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 E:\FR\FM\30MRP1.SGM 30MRP1 Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Proposed Rules lotter on DSK11XQN23PROD with PROPOSALS1 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/ VerDate Sep<11>2014 16:50 Mar 29, 2023 Jkt 259001 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-201509-18/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 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 19027 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 60day extension of the comment period for the color additive petition The request conveyed concern that the current 60day 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 § 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, § 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 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2023–0050] RIN 1625–AA00 Safety Zone; Gallants Channel, Beaufort, NC Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: ACTION: The Coast Guard is proposing to establish a safety zone on the navigable waters of Gallants Channel near Beaufort, NC. The safety zone is necessary to enhance the safety of mariners and participants during the swim portion of a triathlon. Entry of vessels or persons into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) North Carolina or a designated SUMMARY: E:\FR\FM\30MRP1.SGM 30MRP1

Agencies

[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.

-----------------------------------------------------------------------

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
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