Document ID: FDA-1978-N-0018-15815
Agency: fda
Document Type: Notice
Title: Amending Over-the-Counter Monograph M020: Sunscreen Drug
Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
Posted Date: 2021-09-27T04:00Z

[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53322-53324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20780]

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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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of an 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.'' FDA is issuing this 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). This 
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 also sets forth certain characteristics that would 
establish that a sunscreen drug product is not GRASE.

DATES: Submit electronic comments on the proposed order by 11:59 p.m. 
Eastern Time at the end of November 12, 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 November 12, 
2021. The https://www.regulations.gov will accept comments at any time 
until 11:59 p.m. Eastern Time at the end of November 12, 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

[[Page 53323]]

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:

I. Background

    FDA is announcing the availability of an OTC monograph proposed 
order (order ID OTC000008), issued pursuant to section 505G(b) of the 
FD&C Act and section 3854(c)(1) of the CARES Act (Pub. L. 116-136), 
entitled ``Amending Over-the-Counter (OTC) Monograph M020: Sunscreen 
Drug Products for OTC Human Use.'' FDA is issuing this proposed order 
to amend and revise the Deemed Final Order established by the enactment 
of the CARES Act (March 27, 2020).\1\ This 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 GRASE under section 201(p)(1) of the FD&C 
Act. It also sets forth certain characteristics that would establish 
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.''
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    In February 2019, FDA issued a proposed rule entitled ``Sunscreen 
Drug Products for Over-the-Counter Human Use'' (2019 Proposed Rule).\2\ 
The 2019 Proposed Rule proposed to amend the sunscreen monograph 
regulation then codified in 21 CFR part 352, which had been stayed 
since its 1999 issuance, and to put into effect a final monograph for 
sunscreens.\3\ The 2019 Proposed Rule included proposals related to 
sunscreen active ingredients, maximum sun protection factor (SPF) 
levels, broad spectrum requirements, dosage forms, labeling, final 
formulation testing and recordkeeping, sunscreen-insect repellent 
combinations, and more.
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    \2\ The 2019 Proposed Rule (84 FR 6204, February 26, 2019) 
followed from FDA's announcement in 2011 that ``we are considering 
certain active ingredient safety issues further. . . . In a 
forthcoming rulemaking, we intend to request additional data 
regarding the safety of the individual sunscreen active 
ingredients'' (``Revised Effectiveness Determination; Sunscreen Drug 
Products for Over-the-Counter Human Use,'' 76 FR 35672 at 35673, 
June 17, 2011).
    \3\ These proposals included proposed changes to several related 
regulations, including labeling provisions then codified in 21 CFR 
201.327, and to new drug regulations.
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    In addition, because the 2019 Proposed Rule identified a need for 
safety data to support the GRASE status of sunscreens containing 
certain sunscreen active ingredients--and because FDA expected that the 
development of these data could take substantially longer than the 
comment period on the proposed rule--the Agency offered to consider 
requests to defer further rulemaking on these ingredients while the 
data were being developed (see 2019 Proposed Rule 84 FR 6204 at 6249). 
At the end of the comment period on the 2019 Proposed Rule, FDA 
received a significant number of comments, as well as a request to 
defer further rulemaking on avobenzone, homosalate, octinoxate, 
octisalate, octocrylene, oxybenzone, ensulizole, and meradimate while 
data were being developed to support their GRASE status.
    The process for amending the OTC sunscreen monograph was changed by 
the enactment on March 27, 2020, of section 505G of the FD&C Act, as 
added by the CARES Act. Among other things, the CARES Act replaced the 
rulemaking process under which the sunscreen proposed rule had been 
issued with an administrative order process. In addition, section 505G 
of the FD&C Act established that, as of the date of enactment of the 
CARES Act, a sunscreen drug that satisfies certain requirements is 
deemed to be GRASE and not a new drug. The CARES Act also created a 
``final administrative order'' for sunscreens (the Deemed Final Order) 
consisting of ``the requirements specified in [21 CFR part 352], as 
published on May 21, 1999 \4\ . . . except that the applicable 
requirements governing effectiveness and labeling [are] those specified 
in [21 CFR 201.327],'' which the statute established as ``the 
applicable requirements in terms of conformity with a final monograph'' 
for these sunscreen drugs.\5\ The CARES Act directs FDA to amend and 
revise this Deemed Final Order for sunscreens, and requires that the 
proposed version of this revised sunscreen order be issued not later 
than 18 months after the enactment of the CARES Act (i.e., by September 
27, 2021).\6\ The proposed order that is the subject of this document 
is being issued consistent with that requirement.
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    \4\ This refers to the previously-stayed 1999 final monograph 
for sunscreens (1999 Final Monograph).
    \5\ Section 505G(a)(2) of the FD&C Act. Complementary to these 
requirements for conformity to the specified final monograph, 
section 505G also deemed the requirements of certain pre-CARES Act 
monograph rulemaking documents for drugs described by the sunscreen-
specific provisions of section 505G(a)(2), as well as 
``[r]egulations in effect on the day before the date of the 
enactment of [section 505G], establishing requirements for specific 
nonprescription drugs marketed pursuant to [section 505G]'' to be 
final administrative orders under section 505G(b) (see sections 
505G(b)(8) and 505G(k)(2) of the FD&C Act). The resulting document 
(the Deemed Final Order) is available in the in the OTC 
[email protected] portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm.
    \6\ See section 3854(c)(1)(B) of the CARES Act. See also section 
505G(b)(8) of the FD&C Act (stating that final monograph orders, 
specifically including the order consisting of the monograph 
establishing the conditions of use for sunscreen under section 
505G(a)(2), can be ``amended, revoked, or otherwise modified in 
accordance with the procedures of [section 505G(b)]).''
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    FDA proposes that the conditions laid out in the Deemed Final Order 
do not ensure that sunscreen drug products are GRASE under section 
201(p)(1) of the FD&C Act for the reasons explained in the proposed 
order. If finalized, the proposed order 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. It also sets forth certain characteristics 
that would establish that a sunscreen drug product is not GRASE under 
section 201(p)(1) of the FD&C Act.
    In the proposed order, FDA is publishing proposed requirements that 
are substantively the same as those that the Agency described in the 
2019 Proposed Rule, with minor changes, including changes to reflect 
the enactment of section 505G of the FD&C Act. Similarly, our 
scientific discussions regarding sunscreens are generally the same as 
those in the 2019 Proposed Rule. FDA is using this proposed order as a 
vehicle to efficiently transition its ongoing consideration of the 
appropriate requirements for OTC sunscreens marketed without approved 
applications from the previous rulemaking process to the order process 
created by new section 505G of the FD&C Act.
    The 2019 Proposed Rule presented a thorough Agency analysis of 
publicly available data regarding sunscreens at the time of its 
issuance. The legal and scientific standards for general recognition of 
safety and effectiveness underpinning this analysis were not

[[Page 53324]]

changed by the CARES Act.\7\ We are aware that there have been 
scientific developments in the time since the proposed rule was issued 
including, among other things, the publication of two new studies on 
the absorption of sunscreen active ingredients,\8\ both of which 
reinforced the need for the sunscreen ingredient data requested in our 
proposed rule (and in the proposed order). The comment period on this 
proposed order affords an opportunity for the public to submit 
information that has become available since the closure of the comment 
period on the 2019 Proposed Rule. This includes information that has 
become available regarding the eight sunscreen active ingredients, 
identified above, that were the subject of timely requests for deferral 
in order to conduct studies to generate data first identified as 
lacking in the 2019 Proposed Rule. We note that if at any time the 
available evidence becomes sufficient to resolve the uncertainty as to 
the GRASE status of a sunscreen containing any of these ingredients, 
FDA intends to proceed to a revised final order reflecting our 
conclusion as to its status. However, if at the close of the comment 
period on this proposed order, the available data do not resolve the 
outstanding questions about each of these ingredients, but the Agency 
has received satisfactory indication of timely and diligent progress on 
the necessary studies for a specific ingredient, FDA would be prepared 
to initially defer issuance of a revised final order on the GRASE 
status of sunscreens containing that particular active ingredient. Such 
a deferral would be for a period of not more than 1 year, with a 
possibility of extension depending on further satisfactory progress 
with the studies. However, if, in FDA's judgment, studies for any 
active ingredient do not appear to be proceeding in a timely manner or 
otherwise do not appear to be productive, the Agency expects that it 
will proceed to a revised final order on sunscreens containing such 
particular ingredient after this initial deferral.
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    \7\ See section 505G(k)(1) of the FD&C Act and 21 CFR 
330.10(a)(4).
    \8\ See ``FDA in Brief: FDA Announces Results From Second 
Sunscreen Absorption Study,'' available at https://www.fda.gov/news-events/fda-brief/fda-brief-fda-announces-results-second-sunscreen-absorption-study, describing Matta, et al. (2020) (Ref. 1), as well 
as a prior pilot study (Matta, et al. 2019) (Ref. 2).
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    As noted above, the Agency also received a significant number of 
comments to the public docket during the previous public comment period 
on the proposals described in the 2019 Proposed Rule, which we continue 
to review. FDA 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 being 
issued today. To enable the Agency to review and address these comments 
(and future comments that may be submitted on this proposed order) as 
expeditiously as possible, we request that commenters do not resubmit 
comments on this proposed order previously submitted on the proposed 
rule. FDA believes that this approach will allow us to efficiently 
consider public input as the Agency assesses the appropriate regulatory 
requirements for nonprescription sunscreens marketed without approved 
new drug applications.
    We emphasize in the proposed order, and here, that the proposed 
order does not represent a conclusion by FDA that the sunscreen active 
ingredients included in the 1999 Final Monograph, but proposed in the 
order as needing additional data, are unsafe for use in sunscreens. 
Rather, we are requesting additional information on these ingredients 
so that we can evaluate their GRASE status in light of changed 
conditions, including substantially increased sunscreen usage and 
exposure and evolving information about the potential risks associated 
with these products since originally evaluated. As in the 2019 Proposed 
Rule, this proposed order also advances proposals addressing the other 
conditions of use for sunscreen drug products marketed without an 
approved application, including broad spectrum protection, maximum SPF 
requirements, dosage forms, labeling, final formulation testing and 
recordkeeping, sunscreen-insect repellent combinations, and more.

II. Paperwork Reduction Act of 1995

    This proposed order is issued under section 505G(b) of the FD&C 
Act. Chapter 35 of title 44, United States Code does not apply to 
collections of information made under section 505G of the FD&C Act (see 
section 505G(o) of the FD&C Act).

III. Electronic Access

    Persons may obtain the proposed order at the OTC [email protected] 
at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm or at 
https://www.regulations.gov.

IV. References

    The following references are on display with the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not 
available electronically at https://www.regulations.gov as these 
references are copyright protected. Some may be available at the 
website address, if listed. FDA has verified the website addresses, as 
of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

1. Matta, M.K., J. Florian, R. Zusterzeel et al., ``Effect of 
Sunscreen Application on Plasma Concentration of Sunscreen Active 
Ingredients: A Randomized Clinical Trial,'' Journal of the American 
Medical Association, vol. 323(3), pp. 256-267, 2020 (available at 
https://jamanetwork.com/journals/jama/fullarticle/2759002), accessed 
August 12, 2021.
2. Matta, M.K., R. Zusterzeel, R.P. Nageswara Matta et al., ``Effect 
of Sunscreen Application Under Maximal Use Conditions on Plasma 
Concentration of Sunscreen Active Ingredients: A Randomized Clinical 
Trial,'' Journal of the American Medical Association, vol. 321(21), 
pp. 2082-2091, 2019 (available at https://jamanetwork.com/journals/jama/fullarticle/2733085), accessed August 12, 2021.

    Dated: September 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20780 Filed 9-24-21; 8:45 am]
BILLING CODE 4164-01-P