Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period, 66318-66319 [2021-25371]

Download as PDF 66318 Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Notices Dated: November 15, 2021. Lauren K. Roth, Associate Commissioner for Policy. Please note that late, untimely filed comments will not be considered. Comments must be submitted electronically on or before December 27, 2021. The https://www.regulations.gov will accept comments at any time until 11:59 p.m. Eastern Time at the end of December 27, 2021. [FR Doc. 2021–25323 Filed 11–19–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1978–N–0018] Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed order; extension of comment period. ACTION: The Food and Drug Administration (FDA or Agency) has extended the comment period for the over-the-counter (OTC) monograph proposed order (order ID OTC000008) entitled ‘‘Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use’’ (Proposed Order), which was issued on September 24, 2021. A notice of availability for the Proposed Order appeared in the Federal Register of September 27, 2021. FDA issued the Proposed Order to amend and revise the deemed final administrative order concerning nonprescription sunscreen drug products (Deemed Final Order) established by the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Proposed Order, if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be generally recognized as safe and effective (GRASE) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth certain characteristics that would establish that a sunscreen drug product is not GRASE. FDA has extended the comment period for the Proposed Order 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 Proposed Order issued on September 24, 2021 (86 FR 53322). Submit electronic comments on the Proposed Order by 11:59 p.m. Eastern Time at the end of December 27, 2021. ADDRESSES: You may submit comments to Order ID OTC000008 as follows. jspears on DSK121TN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:30 Nov 19, 2021 Jkt 256001 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 information that you or a third party may not wish to be publicly posted, such as medical information or 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 electronically in the manner detailed in Instructions. Instructions: All submissions received must include the Order ID Number OTC000008 and the Docket No. FDA– 1978–N–0018 for ‘‘Amending Over-theCounter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ will be publicly viewable on 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—Under section 505G(d) of the FD&C Act (21 U.S.C. 355h(d)), FDA must make any information submitted by any person with respect to this order available to the public upon submission, with limited exceptions. FDA will not make public information pertaining to pharmaceutical quality information, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section 201(p)(1) of the FD&C Act (21 U.S.C. 321(p)(1)) (see PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 section 505G(d)(2)(B) of the FD&C Act). FDA will also not make public information that is of the type contained in raw datasets (see section 505G(d)(2)(B) of the FD&C Act). To submit a comment with this specific confidential information that you do not wish to be made publicly available, electronically submit two copies of the comment as an attachment to your comment submission. One copy will include the information that 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. The second copy, which will have the claimed information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with section 505G(d) of the FD&C Act, and other applicable disclosure law. Docket: For access to the docket to read background documents or the electronic 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 the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–7945. SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 2021 (86 FR 53322), FDA announced the availability of an OTC monograph proposed order (order ID OTC000008), issued pursuant to section 505G(b) of the FD&C Act (21 U.S.C. 355g(b)) and section 3854(c)(1) of the CARES Act, entitled ‘‘Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use.’’ FDA issued this Proposed Order to amend and revise the Deemed Final Order established by the enactment of the CARES Act, Public Law 116–136 (March 27, 2020).1 This Proposed Order, 1 To address nonprescription sunscreen drug products that are also subject to provisions in other monographs, this proposed order also proposes to amend and revise ‘‘OTC Monograph M016, Skin Protectant Drug Products for Over-the-Counter Human Use,’’ and to consolidate existing and new provisions that identify sunscreens that are not GRASE in ‘‘Non-Monograph Conditions NM020: Sunscreen Drug Products for Over-the-Counter Human Use.’’ E:\FR\FM\22NON1.SGM 22NON1 66319 Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Notices if finalized, would replace the Deemed Final Order in its entirety with new conditions under which nonprescription sunscreen drug products would be determined to be GRASE under section 201(p)(1) of the FD&C Act (21 U.S.C. 321(p)(1)). It would also set forth certain characteristics establishing that a sunscreen drug product is not GRASE under section 201(p)(1) of the FD&C Act. The original close of the public comment period for this Proposed Order was November 12, 2021. On November 2, 2021, the Agency received a request to extend this comment period by a minimum of 45 days, conveying concern that the original comment period did not provide sufficient time for review of the Proposed Order or for submission of needed updates related to sunscreen active ingredients about which FDA had requested additional data. FDA considered the request and extended the public comment period for the Proposed Order for an additional 45 days, until December 27, 2021.2 This extension will allow additional time for the public to submit information related to these active ingredients (and other proposed sunscreen conditions) that has become available since the closure of the comment period on the 2019 Proposed Rule ‘‘Sunscreen Drug Products for Over-the-Counter Human Use’’ (2019 Proposed Rule). The Agency reiterates that, as stated in the notice of availability of the Proposed Order published in the Federal Register on September 27, 2021, and in the Proposed Order itself, the Agency will consider all comments that were submitted to the public docket for the 2019 Proposed Rule within its comment period to be constructively submitted as comments on the Proposed Order. The Agency requests that commenters do not resubmit comments on this Proposed Order previously submitted on the 2019 Proposed Rule. Dated: November 16, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–25371 Filed 11–19–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES jspears on DSK121TN23PROD with NOTICES1 [Document Identifier: OS–0990–0475] Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of the Secretary, HHS. 2 See https://www.regulations.gov/document/ FDA-1978-N-0018-15828. VerDate Sep<11>2014 18:30 Nov 19, 2021 Jkt 256001 ACTION: Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before December 22, 2021. SUMMARY: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795–7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 0990–0475, and project title for reference, to Sherrette Funn, the Reports Clearance Officer, Sherrette.funn@hhs.gov, or call 202– 795–7714. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: ASPA COVID– 19 Public Education Campaign Evaluation Surveys. Type of Collection: Extension. OMB No.: 0990–0475. Abstract: The Office of the Assistant Secretary for Public Affairs (ASPA), U.S. Department of Health and Human Services (HHS) is requesting an extension on a currently approved collection including two components: 1. COVID–19 Attitudes and Beliefs Survey (CABS), and 2. Monthly Outcome Survey (MOS). Throughout execution of the campaign, this information will primarily be used by ASPA to determine whether the campaign is having the intended impact on target audiences’ (e.g., parents, young adults, 65+) knowledge, attitudes, and beliefs as they relate to COVID–19, COVID–19 vaccination, and adherence to preventative behaviors. It will also keep key stakeholders informed of the Campaign’s progress. Ultimately, the data will inform a thorough evaluation of the efficacy of the campaign and its impact on vaccine uptake. ADDRESSES: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 COVID–19 Attitudes and Beliefs Survey (CABS) The CABS is a longitudinal survey that will be fielded tri-annually to 4,000 U.S. adults for the duration of the Campaign via NORC at the University of Chicago’s AmeriSpeak Panel. The survey will be fielded online, and each fielding period will last between 3 and 6 weeks. Those that respond to wave 1 of the survey will be recontacted in each wave, facilitating a comparison of COVID–19 behavior change over time for a representative sample and evaluation of U.S. adults. Panel members selected to participate in the study will receive one pre-invitation postcard in the mail, one email invitation, and three email reminders to complete the survey in each wave. Monthly Outcome Survey (MOS) The MOS is a shorter, cross-sectional survey that will be fielded monthly to 5,000 U.S. adults for the duration of the Campaign via the Ipsos KnowledgePanel 5K Omnibus Survey. The survey will be fielded online, and each fielding period will last between 7 and 10 days. ANNUALIZED BURDEN HOUR TABLE CABS Hours to complete survey .................... Participants (per wave) ..................... Number of waves (per year) .............. Total respondents per year ....................... Total burden hours per year ................. MOS 0.58 0.17 4,000 5,000 3 12 12,000 60,000 6,960 10,200 Sum of Both Studies Total respondents per year: 72,000. Total burden hours per year: 17,160. Sherrette A. Funn, Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary. [FR Doc. 2021–25370 Filed 11–19–21; 8:45 am] BILLING CODE 4150–25–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; NIH COVID–19 Vaccination Status Form Extension AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork SUMMARY: E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66318-66319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1978-N-0018]


Amending Over-the-Counter Monograph M020: Sunscreen Drug Products 
for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed 
Order (OTC 000008) Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has extended 
the comment period for the over-the-counter (OTC) monograph proposed 
order (order ID OTC000008) entitled ``Amending Over-the-Counter (OTC) 
Monograph M020: Sunscreen Drug Products for OTC Human Use'' (Proposed 
Order), which was issued on September 24, 2021. A notice of 
availability for the Proposed Order appeared in the Federal Register of 
September 27, 2021. FDA issued the Proposed Order to amend and revise 
the deemed final administrative order concerning nonprescription 
sunscreen drug products (Deemed Final Order) established by the 
enactment of the Coronavirus Aid, Relief, and Economic Security Act 
(CARES Act). The Proposed Order, if finalized, would replace the Deemed 
Final Order in its entirety with new conditions under which 
nonprescription sunscreen drug products would be determined to be 
generally recognized as safe and effective (GRASE) under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). It would also set forth 
certain characteristics that would establish that a sunscreen drug 
product is not GRASE. FDA has extended the comment period for the 
Proposed Order 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 Proposed Order issued 
on September 24, 2021 (86 FR 53322). Submit electronic comments on the 
Proposed Order by 11:59 p.m. Eastern Time at the end of December 27, 
2021.

ADDRESSES: You may submit comments to Order ID OTC000008 as follows. 
Please note that late, untimely filed comments will not be considered. 
Comments must be submitted electronically on or before December 27, 
2021. The https://www.regulations.gov will accept comments at any time 
until 11:59 p.m. Eastern Time at the end of December 27, 2021.

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 information that you or a third party may not wish 
to be publicly posted, such as medical information or 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 electronically in the manner detailed in 
Instructions.
    Instructions: All submissions received must include the Order ID 
Number OTC000008 and the Docket No. FDA-1978-N-0018 for ``Amending 
Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC 
Human Use.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' will be publicly viewable on 
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--Under section 505G(d) of the 
FD&C Act (21 U.S.C. 355h(d)), FDA must make any information submitted 
by any person with respect to this order available to the public upon 
submission, with limited exceptions. FDA will not make public 
information pertaining to pharmaceutical quality information, unless 
such information is necessary to establish standards under which a drug 
is generally recognized as safe and effective under section 201(p)(1) 
of the FD&C Act (21 U.S.C. 321(p)(1)) (see section 505G(d)(2)(B) of the 
FD&C Act). FDA will also not make public information that is of the 
type contained in raw datasets (see section 505G(d)(2)(B) of the FD&C 
Act). To submit a comment with this specific confidential information 
that you do not wish to be made publicly available, electronically 
submit two copies of the comment as an attachment to your comment 
submission. One copy will include the information that 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. The second copy, which 
will have the claimed information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with section 505G(d) of the FD&C Act, and other 
applicable disclosure law.
    Docket: For access to the docket to read background documents or 
the electronic 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 the 
Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 240-402-7945.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
2021 (86 FR 53322), FDA announced the availability of an OTC monograph 
proposed order (order ID OTC000008), issued pursuant to section 505G(b) 
of the FD&C Act (21 U.S.C. 355g(b)) and section 3854(c)(1) of the CARES 
Act, entitled ``Amending Over-the-Counter (OTC) Monograph M020: 
Sunscreen Drug Products for OTC Human Use.'' FDA issued this Proposed 
Order to amend and revise the Deemed Final Order established by the 
enactment of the CARES Act, Public Law 116-136 (March 27, 2020).\1\ 
This Proposed Order,

[[Page 66319]]

if finalized, would replace the Deemed Final Order in its entirety with 
new conditions under which nonprescription sunscreen drug products 
would be determined to be GRASE under section 201(p)(1) of the FD&C Act 
(21 U.S.C. 321(p)(1)). It would also set forth certain characteristics 
establishing that a sunscreen drug product is not GRASE under section 
201(p)(1) of the FD&C Act.
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    \1\ To address nonprescription sunscreen drug products that are 
also subject to provisions in other monographs, this proposed order 
also proposes to amend and revise ``OTC Monograph M016, Skin 
Protectant Drug Products for Over-the-Counter Human Use,'' and to 
consolidate existing and new provisions that identify sunscreens 
that are not GRASE in ``Non-Monograph Conditions NM020: Sunscreen 
Drug Products for Over-the-Counter Human Use.''
---------------------------------------------------------------------------

    The original close of the public comment period for this Proposed 
Order was November 12, 2021. On November 2, 2021, the Agency received a 
request to extend this comment period by a minimum of 45 days, 
conveying concern that the original comment period did not provide 
sufficient time for review of the Proposed Order or for submission of 
needed updates related to sunscreen active ingredients about which FDA 
had requested additional data. FDA considered the request and extended 
the public comment period for the Proposed Order for an additional 45 
days, until December 27, 2021.\2\ This extension will allow additional 
time for the public to submit information related to these active 
ingredients (and other proposed sunscreen conditions) that has become 
available since the closure of the comment period on the 2019 Proposed 
Rule ``Sunscreen Drug Products for Over-the-Counter Human Use'' (2019 
Proposed Rule).
---------------------------------------------------------------------------

    \2\ See https://www.regulations.gov/document/FDA-1978-N-0018-15828.
---------------------------------------------------------------------------

    The Agency reiterates that, as stated in the notice of availability 
of the Proposed Order published in the Federal Register on September 
27, 2021, and in the Proposed Order itself, the Agency will consider 
all comments that were submitted to the public docket for the 2019 
Proposed Rule within its comment period to be constructively submitted 
as comments on the Proposed Order. The Agency requests that commenters 
do not resubmit comments on this Proposed Order previously submitted on 
the 2019 Proposed Rule.

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25371 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P

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