Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
| Citation | 86 FR 53322 |
| Record Number | 2021-20780 |
| Published date | 27 September 2021 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 184 (Monday, September 27, 2021)
[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
