[113th Congress Public Law 195]
[From the U.S. Government Publishing Office]
[[Page 128 STAT. 2035]]
Public Law 113-195
113th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to provide an
alternative process for review of safety and effectiveness of
nonprescription sunscreen active ingredients and for other
purposes. <<NOTE: Nov. 26, 2014 - [S. 2141]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Sunscreen
Innovation Act.>>
SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This Act may be cited as the ``Sunscreen Innovation Act''.
SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE
INGREDIENTS.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:
``Subchapter I--Nonprescription Sunscreen and Other Active Ingredients
``SEC. 586. <<NOTE: 21 USC 360fff.>> DEFINITIONS.
``In this subchapter--
``(1) the term `Advisory Committee' means the
Nonprescription Drug Advisory Committee of the Food and Drug
Administration or any successor to such Committee;
``(2) the term `final sunscreen order' means an order
published by the Secretary in the Federal Register containing
information stating that a nonprescription sunscreen active
ingredient or combination of nonprescription sunscreen active
ingredients--
``(A) is GRASE and is not misbranded if marketed in
accordance with such order; or
``(B) is not GRASE and is misbranded;
``(3) the term `GRASE' means generally recognized, among
experts qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, as safe and
effective for use under the conditions prescribed, recommended,
or suggested in the labeling of a drug as described in section
201(p);
``(4) the term `GRASE determination' means, with respect to
a nonprescription active ingredient or a combination of
nonprescription active ingredients, a determination of whether
such ingredient or combination of ingredients is GRASE;
``(5) the term `nonprescription' means not subject to
section 503(b)(1);
[[Page 128 STAT. 2036]]
``(6) the term `pending request' means each request with
respect to a nonprescription sunscreen active ingredient
submitted under section 330.14 of title 21, Code of Federal
Regulations (as in effect on the date of enactment of the
Sunscreen Innovation Act) for consideration for inclusion in the
over-the-counter drug monograph system--
``(A) that was determined to be eligible for such
review by publication of a notice of eligibility in the
Federal Register prior to the date of enactment of such
Act; and
``(B) for which safety and effectiveness data have
been submitted to the Secretary prior to such date of
enactment;
``(7) the term `proposed sunscreen order' means an order
containing a tentative determination published by the Secretary
in the Federal Register containing information proposing that a
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients--
``(A) is GRASE and is not misbranded if marketed in
accordance with such order;
``(B) is not GRASE and is misbranded; or
``(C) is not GRASE and is misbranded because the
data are insufficient to classify such ingredient or
combination of ingredients as GRASE and not misbranded
and additional information is necessary to allow the
Secretary to determine otherwise;
``(8) the term `sponsor' means the person that submitted--
``(A) a request under section 586A;
``(B) a pending request; or
``(C) any other application subject to this
subchapter;
``(9) the term `sunscreen' means a drug containing one or
more sunscreen active ingredients; and
``(10) the term `sunscreen active ingredient' means an
active ingredient that is intended for application to the skin
of humans for purposes of absorbing, reflecting, or scattering
ultraviolet radiation.
``SEC. 586A. <<NOTE: 21 USC 360fff-1.>> SUBMISSION OF REQUESTS.
``Any person may submit a request to the Secretary for a
determination of whether a nonprescription sunscreen active ingredient
or a combination of nonprescription sunscreen active ingredients, for
use under specified conditions, to be prescribed, recommended, or
suggested in the labeling thereof (including dosage form, dosage
strength, and route of administration) is GRASE and should be included
in part 352 of title 21, Code of Federal Regulations (or any successor
regulations) concerning nonprescription sunscreen.
``SEC. 586B. <<NOTE: 21 USC 360fff-2.>> ELIGIBILITY
DETERMINATIONS; DATA SUBMISSION; FILING.
``(a) Eligibility Determinations.--
``(1) <<NOTE: Deadline.>> In general.--Not later than 60
calendar days after the date of receipt of a request under
section 586A, the Secretary shall--
``(A) determine, in accordance with paragraph (2),
whether the request is eligible for further review under
subsection (b) and section 586C;
``(B) <<NOTE: Notification.>> notify the sponsor of
the determination of the Secretary; and
[[Page 128 STAT. 2037]]
``(C) <<NOTE: Public information.>> make such
determination publicly available in accordance with
paragraph (3) and subsection (b)(1).
``(2) Criteria for eligibility.--
``(A) In general.--To be eligible for review under
subsection (b) and section 586C, a request shall be for
a nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients, for use under specified conditions, to be
prescribed, recommended, or suggested in the labeling
thereof, that--
``(i) is not included in part 352 of title 21,
Code of Federal Regulations (or any successor
regulations) concerning nonprescription sunscreen;
and
``(ii) has been used to a material extent and
for a material time under such conditions, as
described in section 201(p)(2).
``(B) Establishment of time and extent.--A sponsor
shall include in a request under section 586A the
information required under section 330.14 of title 21,
Code of Federal Regulations (or any successor
regulations) to meet the standard described in
subparagraph (A)(ii).
``(3) Public availability.--
``(A) Redactions for confidential information.--If a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is determined under paragraph (1)(A) to be
eligible for further review, the Secretary shall make
the request publicly available, with redactions for
information that is treated as confidential under
section 552(b) of title 5, United States Code, section
1905 of title 18, United States Code, or section 301(j)
of this Act.
``(B) Identification of confidential information by
sponsor.--At the time that a request is made under
section 586A, the sponsor of such request shall identify
any information that such sponsor considers to be
confidential information described in subparagraph (A).
``(C) Confidentiality during eligibility review.--
The information contained in a request under section
586A shall remain confidential during the Secretary's
consideration under this section of whether the request
is eligible for further review consistent with section
330.14 of title 21, Code of Federal Regulations (or any
successor regulations).
``(b) Data Submission and Filing of Requests.--
``(1) <<NOTE: Web posting. Deadline.>> In general.--In the
case of a request under section 586A that is determined to be
eligible under subsection (a) for further review under this
section and section 586C, the Secretary shall, in notifying the
public under subsection (a)(1)(C) of such eligibility
determination, post the eligibility determination on the
Internet website of the Food and Drug Administration, invite the
sponsor of such request and any other interested party to submit
comments, and provide a period of not less than 45 calendar days
for comments in support of or otherwise relating to a GRASE
determination, including published and unpublished data and
other information related to the safety and efficacy of such
request.
``(2) <<NOTE: Deadlines.>> Filing determination.--Not later
than 60 calendar days after the submission of data and other
information
[[Page 128 STAT. 2038]]
described in paragraph (1) by the sponsor, the Secretary shall
determine whether the data and other information submitted by
the sponsor under this section are sufficiently complete,
including being formatted in a manner that enables the Secretary
to determine the completeness of such data and information, to
enable the Secretary to conduct a substantive review under
section 586C with respect to such request. Not later than 60
calendar days after the submission of data and other information
described in paragraph (1) by the sponsor, if the Secretary
determines--
``(A) <<NOTE: Notification. Public information.>>
that such data and other information are sufficiently
complete, the Secretary shall--
``(i) issue a written notification to the
sponsor of the determination to file such request,
and make such notification publicly available; and
``(ii) file such request made under section
586A; or
``(B) that such data and other information are not
sufficiently complete, the Secretary shall issue a
written notification to the sponsor of the determination
to refuse to file the request, which shall include the
reasons for the refusal, including why such data and
other information are not sufficiently complete, and
make such notification publicly available.
``(3) <<NOTE: Deadlines.>> Refusal to file a request.--
``(A) Request for meetings; submission of additional
data or other information.--If the Secretary refuses to
file a request made under section 586A, the sponsor
may--
``(i) <<NOTE: Notification.>> within 30
calendar days of receipt of written notification
of such refusal, request, in writing, a meeting
with the Secretary regarding the filing
determination; and
``(ii) submit additional data or other
information.
``(B) Meetings.--
``(i) In general.--If a sponsor seeks a
meeting under subparagraph (A)(i), the Secretary
shall convene the meeting within 30 calendar days
of the request for such meeting.
``(ii) Actions after meeting.--Following any
meeting held under clause (i)--
``(I) the Secretary may file the
request within 60 calendar days;
``(II) the sponsor may submit
additional data or other information; or
``(III) if the sponsor elects,
within 120 calendar days, to have the
Secretary file the request (with or
without amendments to correct any
purported deficiencies to the request)--
``(aa) the Secretary shall
file the request over protest,
not later than 30 calendar days
after the sponsor makes such
election;
``(bb) <<NOTE: Notification.>>
at the time of filing, the
Secretary shall provide written
notification of such filing to
the sponsor; and
``(cc) <<NOTE: Public
information.>> the Secretary
shall make such notification
publicly available.
[[Page 128 STAT. 2039]]
``(iii) Requests filed over protest.--The
Secretary shall not require the sponsor to
resubmit a copy of the request for purposes of
filing a request filed over protest, as described
in clause (ii)(III).
``(C) Submissions of additional data or other
information.--Within 60 calendar days of any submission
of additional data or other information under
subparagraph (A)(ii) or (B)(ii)(II), the Secretary shall
reconsider the previous determination made under
paragraph (2) with respect to the applicable request and
make a new determination in accordance with paragraph
(2).
``(4) Public availability.--
``(A) Redactions for confidential information.--
After the period of confidentiality described in
subsection (a)(3)(C), the Secretary shall make data and
other information submitted in connection with a request
under section 586A publicly available, with redactions
for information that is treated as confidential under
section 552(b) of title 5, United States Code, section
1905 of title 18, United States Code, or section 301(j)
of this Act.
``(B) Identification of confidential information by
sponsor.--A person submitting information under this
section shall identify at the time of such submission
the portions of such information that the person
considers to be confidential information described in
subparagraph (A).
``SEC. 586C. <<NOTE: 21 USC 360fff-3.>> GRASE DETERMINATION.
``(a) <<NOTE: Deadlines.>> Review of New Request.--
``(1) Proposed sunscreen order.--In the case of a request
under section 586A, not later than 300 calendar days after the
date on which such request is filed under subsection (b)(2)(A)
or (b)(3)(B)(ii)(III) of section 586B, the Secretary--
``(A) may convene a meeting of the Advisory
Committee to review such request; and
``(B) shall complete the review of such request and
issue a proposed sunscreen order with respect to such
request.
``(2) Proposed sunscreen order by commissioner.--If the
Secretary does not issue a proposed sunscreen order under
paragraph (1)(B) within such 300-day period, the sponsor of such
request may notify the Office of the Commissioner of such
request and request review by the Office of the Commissioner. If
such sponsor so notifies the Office of the Commissioner, the
Commissioner shall, not later than 60 calendar days after the
date of notification under this paragraph, issue a proposed
sunscreen order with respect to such request.
``(3) Public comment period.--A proposed sunscreen order
issued under paragraph (1)(B) or (2) with respect to a request
shall provide for a period of 45 calendar days for public
comment.
``(4) Meeting.--A sponsor may request, in writing, a meeting
with respect to a proposed sunscreen order issued under this
subsection and described in subparagraph (B) or (C) of section
586(7), not later than 30 calendar days after the Secretary
issues such order. The Secretary shall convene a meeting with
such sponsor not later than 45 calendar days after such request
for a meeting.
[[Page 128 STAT. 2040]]
``(5) Final sunscreen order.--With respect to a proposed
sunscreen order under paragraph (1)(B) or (2)--
``(A) the Secretary shall issue a final sunscreen
order--
``(i) in the case of a proposed sunscreen
order described in subparagraph (A) or (B) of
section 586(7), not later than 90 calendar days
after the end of the public comment period under
paragraph (3); or
``(ii) in the case of a proposed sunscreen
order described in subparagraph (C) of section
586(7), not later than 210 calendar days after the
date on which the sponsor submits the additional
information requested pursuant to such proposed
sunscreen order; or
``(B) if the Secretary does not issue such final
sunscreen order within such 90- or 210-calendar-day
period, as applicable, the sponsor of such request may
notify the Office of the Commissioner of such request
and request review by the Office of the Commissioner.
``(6) Final sunscreen order by commissioner.--The
Commissioner shall issue a final sunscreen order with respect to
a proposed sunscreen order subject to paragraph (5)(B) not later
than 60 calendar days after the date of notification under such
paragraph.
``(b) <<NOTE: Deadlines.>> Review of Pending Requests.--
``(1) In general.--The review of a pending request shall be
carried out by the Secretary in accordance with this subsection.
``(2) Inapplicability of sections 586a and 586b.--Sections
586A and 586B shall not apply with respect to any pending
request.
``(3) <<NOTE: Web posting.>> Feedback letters as proposed
sunscreen order.--Notwithstanding the requirements of section
586(7), a letter issued pursuant to section 330.14(g) of title
21, Code of Federal Regulations before the date of enactment of
the Sunscreen Innovation Act, with respect to a pending request,
shall be deemed to be a proposed sunscreen order and displayed
on the Internet website of the Food and Drug Administration.
Notification <<NOTE: Notification. Federal Register,
publication.>> of the availability of such letter shall be
published in the Federal Register not later than 45 calendar
days after the date of enactment of such Act.
``(4) Proposed sunscreen order.--In the case of a pending
request for which the Secretary has not issued a letter pursuant
to section 330.14(g) of title 21, Code of Federal Regulations
before the date of enactment of the Sunscreen Innovation Act,
the Secretary shall complete review of such request and, not
later than 90 calendar days after the date of enactment of such
Act, issue a proposed sunscreen order with respect to such
request.
``(5) Proposed sunscreen order by commissioner.--If the
Secretary does not issue a proposed sunscreen order under
paragraph (4), or the Secretary does not publish a notification
of the availability of a letter under paragraph (3), as
applicable, the sponsor of such request may notify the Office of
the Commissioner of such request and request review by the
Office of the Commissioner. The Commissioner shall, not later
than 60 calendar days after the date of notification under this
paragraph, issue a proposed order with respect to such request.
[[Page 128 STAT. 2041]]
``(6) Public comment period.--A proposed sunscreen order
issued under paragraph (4) or (5), or a notification of the
availability of a letter under paragraph (3), with respect to a
pending request shall provide for a period of 45 calendar days
for public comment.
``(7) Meeting.--A sponsor may request, in writing, a meeting
with respect to a proposed sunscreen order issued under this
subsection, including a letter deemed to be a proposed sunscreen
order under paragraph (3), not later than 30 calendar days after
the Secretary issues such order or the date upon which such
feedback letter is deemed to be a proposed sunscreen order, as
applicable. The Secretary shall convene a meeting with such
sponsor not later than 45 calendar days after the date of such
request for a meeting.
``(8) Advisory committee.--In the case of a proposed
sunscreen order under paragraph (3), (4), or (5), an Advisory
Committee meeting may be convened for the purpose of reviewing
and providing recommendations regarding the pending request.
``(9) Final sunscreen order.--In the case of a proposed
sunscreen order under paragraph (3), (4), or (5)--
``(A) the Secretary shall issue a final sunscreen
order with respect to the request--
``(i) in the case of a proposed sunscreen
order described in subparagraph (A) or (B) of
section 586(7), not later than 90 calendar days
after the end of the public comment period under
paragraph (6); or
``(ii) in the case of a proposed sunscreen
order described in subparagraph (C) of section
586(7)--
``(I) if the Advisory Committee is
not convened under paragraph (8), not
later than 210 calendar days after the
date on which the sponsor submits the
additional information requested
pursuant to such proposed sunscreen
order, which shall include a rationale
for not convening such Advisory
Committee; or
``(II) if the Advisory Committee is
convened under paragraph (8), not later
than 270 calendar days after the date on
which the sponsor submits such
additional information; or
``(B) <<NOTE: Notification.>> if the Secretary does
not issue such final sunscreen order within such 90-,
210-, or 270-calendar-day period, as applicable, the
sponsor of such request may notify the Office of the
Commissioner about such request and request review by
the Office of the Commissioner.
``(10) Final sunscreen order by commissioner.--The
Commissioner shall issue a final sunscreen order with respect to
a proposed sunscreen order subject to paragraph (9)(B) not later
than 60 calendar days after the date of notification under such
paragraph.
``(c) Advisory Committee.--The Secretary shall not be required to--
``(1) convene the Advisory Committee--
``(A) more than once with respect to any request
under section 586A or any pending request; or
``(B) more than twice in any calendar year with
respect to the review under this section; or
[[Page 128 STAT. 2042]]
``(2) submit more than a total of 3 requests under section
586A or pending requests to the Advisory Committee per meeting.
``(d) No Delegation.--Any responsibility vested in the Commissioner
by subsection (a)(2), (a)(6), (b)(5), or (b)(10) shall not be delegated.
``(e) Effect of Final Sunscreen Order.--
``(1) In general.--
``(A) Sunscreen active ingredients determined to be
grase.--Upon issuance of a final sunscreen order
determining that a nonprescription sunscreen active
ingredient or combination of nonprescription sunscreen
active ingredients is GRASE and is not misbranded, a
sunscreen containing such ingredient or combination of
ingredients shall be permitted to be introduced or
delivered into interstate commerce for use under the
conditions described in such final sunscreen order, in
accordance with all requirements applicable to drugs not
subject to section 503(b)(1), for so long as such final
sunscreen order remains in effect.
``(B) Sunscreen active ingredients determined not to
be grase.--Upon issuance of a final sunscreen order
determining that a nonprescription sunscreen active
ingredient or combination of nonprescription sunscreen
active ingredients is not GRASE and is misbranded, a
sunscreen containing such ingredient or combination of
ingredients shall not be introduced or delivered into
interstate commerce, for use under the conditions
described in such final sunscreen order, unless an
application is approved pursuant to section 505 with
respect to a sunscreen containing such ingredient or
combination of ingredients, or unless conditions are
later established under which such ingredient or
combination of ingredients is later determined to be
GRASE and not misbranded under the over-the-counter drug
monograph system.
``(2) Amendments to final sunscreen orders.--
``(A) Amendments at initiative of secretary.--In the
event that information relevant to a nonprescription
sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients becomes
available to the Secretary after issuance of a final
sunscreen order, the Secretary may amend such final
sunscreen order by issuing a new proposed sunscreen
order under subsection (a)(1) and following the
procedures set forth in this section.
``(B) Petition to amend final order.--Any interested
person may petition the Secretary to amend a final
sunscreen order under section 10.30, title 21 Code of
Federal Regulations (or any successor regulations). If
the Secretary grants any petition under such section,
the Secretary shall initiate the process for amending a
final sunscreen order by issuing a new proposed
sunscreen order under subsection (a)(1) and following
the procedures set forth in this section.
``(C) Applicability of final orders.--Once the
Secretary issues a new proposed sunscreen order to amend
a final sunscreen order under subparagraph (A) or (B),
such final sunscreen order shall remain in effect and
paragraph (3) shall not apply to such final sunscreen
order
[[Page 128 STAT. 2043]]
until the Secretary has issued a new final sunscreen
order or has determined not to amend the final sunscreen
order.
``(3) Inclusion of ingredients that are subjects of final
orders in the sunscreen monograph.--
``(A) Amending regulations.--
``(i) Requirement.--At any time that the
Secretary proposes to amend part 352 of title 21,
Code of Federal Regulations (or any successor
regulations) concerning nonprescription sunscreen,
including pursuant to section 586E, except as
provided in clause (iv), the Secretary shall
include in such part 352 (or any successor
regulations) any nonprescription sunscreen active
ingredient or combination of nonprescription
sunscreen active ingredients that is the subject
of an effective final sunscreen order of the type
described in section 586(2)(A) and issued since
the time that the Secretary last amended such
regulations. Such regulation shall set forth
conditions of use under which each such ingredient
or combination of ingredients is GRASE and not
misbranded. <<NOTE: Notification. Public
comments. Extension.>> If these conditions differ
from, or are in addition to, those previously set
forth in the applicable final sunscreen order, the
Secretary shall provide notice and opportunity for
comment on such conditions in the rulemaking, and
the applicable final sunscreen order shall
continue in effect until the effective date of a
final regulation, as set forth in clause (iii).
``(ii) <<NOTE: Lists. Termination date.>>
Inclusion of orders.--In proposing to amend the
regulations as described in clause (i), the
Secretary shall include in the proposed
regulations a list of final sunscreen orders that
shall cease to be effective on the effective date
of a resulting final regulation. Such list shall
include all final sunscreen orders of the type
described in section 586(2)(A) that are in effect
on the date that such regulations are proposed,
with the exception that such list shall not
include any final sunscreen orders that, on the
date that the regulations are proposed, the
Secretary is in the process of amending under
paragraph (2).
``(iii) Orders no longer effective.--Any final
sunscreen order included by the Secretary in a
list described in clause (ii) and in a list
included in resulting final regulations shall
cease to be effective on the date that such final
regulations including such order in such list
become effective.
``(iv) Ingredients not grase.--If,
notwithstanding a final sunscreen order stating
that a nonprescription sunscreen active ingredient
or combination of nonprescription sunscreen active
ingredients is GRASE and is not misbranded if
marketed in accordance with such order, while
amending the regulations as described in clause
(i), the Secretary concludes that such ingredient
or combination of ingredients is no longer GRASE
for use in nonprescription sunscreen, the
Secretary shall, at the discretion of the
Secretary,
[[Page 128 STAT. 2044]]
either initiate the process for amending the final
sunscreen order set forth in paragraph (2) of this
subsection or include in a proposed regulation an
explanation and information supporting the
determination of the Secretary that such
ingredient or combination of ingredients is no
longer GRASE for use in nonprescription sunscreen.
``(B) Procedure for updating regulations.--After the
Secretary amends and finalizes the regulations under
part 352 of title 21, Code of Federal Regulations under
section 586E and such regulations become effective, the
Secretary may use direct final rulemaking to include in
such regulations any nonprescription sunscreen active
ingredients that are the subject of effective final
sunscreen orders.
``SEC. 586D. <<NOTE: 21 USC 360fff-4.>> GUIDANCE; OTHER
PROVISIONS.
``(a) Guidance.--
``(1) In general.--
``(A) <<NOTE: Deadline.>> Draft guidance.--Not
later than 1 year after the date of enactment of the
Sunscreen Innovation Act, the Secretary shall issue
draft guidance on the implementation of, and compliance
with, the requirements with respect to sunscreen under
this subchapter, including guidance on--
``(i) the format and content of information
submitted by a sponsor in support of a request
under section 586A or a pending request;
``(ii) the data required to meet the safety
and efficacy standard for determining whether a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is GRASE and is not misbranded;
``(iii) the process by which a request under
section 586A or a pending request is withdrawn;
and
``(iv) the process by which the Secretary will
carry out section 586C(c), including with respect
to how the Secretary will address the total number
of requests received under section 586A and
pending requests.
``(B) <<NOTE: Deadline.>> Final guidance.--The
Secretary shall finalize the guidance described in
subparagraph (A) not later than 2 years after the date
of enactment of the Sunscreen Innovation Act.
``(C) Inapplicability of paperwork reduction act.--
Chapter 35 of title 44, United States Code shall not
apply to collections of information made for purposes of
guidance under this subsection.
``(2) Submissions pending issuance of final guidance.--
Irrespective of whether final guidance under paragraph (1) has
been issued--
``(A) persons may, beginning on the date of
enactment of the Sunscreen Innovation Act, make
submissions under this subchapter; and
``(B) <<NOTE: Review.>> the Secretary shall review
and act upon such submissions in accordance with this
subchapter.
``(b) Rules of Construction.--
[[Page 128 STAT. 2045]]
``(1) Currently marketed sunscreens.--Nothing in this
subchapter shall be construed to affect the marketing of
sunscreens that are marketed in interstate commerce on or before
the date of enactment of this subchapter, except as otherwise
provided in this subchapter.
``(2) Ensuring safety and effectiveness.--Nothing in this
subchapter shall be construed to alter the authority of the
Secretary with respect to prohibiting the marketing of a
sunscreen that is not safe and effective or is misbranded, or
with respect to imposing restrictions on the marketing of a
sunscreen to ensure safety and effectiveness, except as
otherwise provided in this subchapter, including section
586C(e).
``(3) Other drugs.--Except as otherwise provided in section
586F, nothing in this subchapter shall be construed to affect
the authority of the Secretary under this Act or the Public
Health Service Act (42 U.S.C. 201 et seq.) with respect to a
drug other than a nonprescription sunscreen.
``(4) Effect on drugs otherwise approved.--Nothing in this
subchapter shall affect the marketing of a drug approved under
section 505 of this Act or section 351 of the Public Health
Service Act.
``(c) Timelines.--The timelines for the processes and procedures
under paragraphs (1), (2), (5), and (6) of section 586C(a) shall not
apply to any requests submitted to the Secretary under section 586A
after the date that is 6 years after the date of enactment of the
Sunscreen Innovation Act.
``SEC. 586E. <<NOTE: 21 USC 360fff-5.>> SUNSCREEN MONOGRAPH.
``(a) <<NOTE: Deadlines. Regulations.>> In General.--Not later than
5 years after the date of enactment of the Sunscreen Innovation Act, the
Secretary shall amend and finalize regulations under part 352 of title
21, Code of Federal Regulations concerning nonprescription sunscreen
that are effective not later than 5 years after such date of enactment.
The <<NOTE: Publication.>> Secretary shall publish such regulations not
less than 30 calendar days before the effective date of such
regulations.
``(b) Reports.--If the regulations promulgated under subsection (a)
do not include provisions related to the effectiveness of various sun
protection factor levels, and do not address all dosage forms known to
the Secretary to be used in sunscreens marketed in the United States
without a new drug approval under section 505, the Secretary shall
submit a report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives on the rationale for such provisions not being
included in such regulations, and a plan and timeline to compile any
information necessary to address such provisions through final
regulations.''.
(b) <<NOTE: 21 USC 360 note.>> Rules of Construction.--Nothing in
the amendment made by this section shall be construed to--
(1) limit the right of a sponsor (as defined in section
586(8) of the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a)) to request that the Secretary of Health and
Human Services convene an advisory committee; or
(2) limit the authority of the Secretary of Health and Human
Services to meet with a sponsor (as defined in section 586(8) of
the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a)).
[[Page 128 STAT. 2046]]
SEC. 3. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS.
Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic
Act, as added by section 2, is amended by adding at the end the
following:
``SEC. 586F. <<NOTE: 21 USC 360fff-6.>> NON-SUNSCREEN TIME AND
EXTENT APPLICATIONS.
``(a) <<NOTE: Deadlines.>> Pending Time and Extent Applications.--
``(1) In general.--
``(A) Request for framework for review.--If, prior
to the date of enactment of the Sunscreen Innovation
Act, an application was submitted pursuant to section
330.14 of title 21, Code of Federal Regulations for a
GRASE determination for a drug other than a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients and such drug was found to be eligible to be
considered for inclusion in the over-the-counter drug
monograph system pursuant to section 330.14 of title 21,
Code of Federal Regulations, the sponsor of such
application may request that the Secretary provide a
framework under paragraph (2) for the review of such
application.
``(B) Request requirements.--A request for a
framework for review of an application made under
subparagraph (A) shall be made within 180 calendar days
of the date of enactment of the Sunscreen Innovation Act
and shall include the preference of such sponsor as to
whether such application is reviewed by the Secretary in
accordance with--
``(i) the processes and procedures set forth
for pending requests under section 586C(b), except
that specific timelines shall be determined in
accordance with other applicable requirements
under this section;
``(ii) the processes and procedures set forth
under part 330 of title 21, Code of Federal
Regulations (or any successor regulations);
``(iii) an initial filing determination under
the processes and procedures described in section
586B(b) and the processes and procedures set forth
for pending requests under section 586C(b), except
that specific timelines shall be determined in
accordance with other applicable requirements
under this section; or
``(iv) an initial filing determination under
the processes and procedures described in section
586B(b) and the processes and procedures set forth
under part 330 of title 21, Code of Federal
Regulations (or any successor regulations).
``(C) No request.--If a sponsor described in
subparagraph (A) does not make such request within 180
calendar days of the date of enactment of the Sunscreen
Innovation Act, such application shall be reviewed by
the Secretary in accordance with the timelines of the
applicable regulations when such regulations are
finalized under subsection (b).
``(2) <<NOTE: Deadline. Notification.>> Framework.--Not
later than 1 year after the date of enactment of the Sunscreen
Innovation Act, the Secretary shall provide, in writing, a
framework to each sponsor that submitted a request under
paragraph (1). Such framework shall
[[Page 128 STAT. 2047]]
set forth the various timelines, in calendar days, with respect
to the processes and procedures for review under clauses (i),
(ii), (iii), and (iv) of paragraph (1)(B) and--
``(A) such timelines shall account for the
considerations under paragraph (5); and
``(B) the timelines for the various processes and
procedures shall not be shorter than the timelines set
forth for pending requests under sections 586B(b) and
586C(b), as applicable.
``(3) Governing processes and procedures for review.--
``(A) Election.--Not later than 60 calendar days
after the Secretary provides a framework to a sponsor
under paragraph (2), such sponsor may provide an
election to the Secretary regarding the processes and
procedures for review under clause (i), (ii), (iii), or
(iv) of paragraph (1)(B). If such sponsor makes such
election, the Secretary shall review the application
that is the subject of such election pursuant to the
processes and procedures elected by such sponsor and the
applicable timelines in calendar days set forth under
such framework, which the Secretary shall confirm in
writing to the sponsor not later than the date upon
which the Secretary provides a report under paragraph
(4). If such sponsor does not make such election, such
application shall be reviewed by the Secretary in
accordance with the timelines of the applicable
regulations when such regulations are finalized under
subsection (b).
``(B) Different processes and procedures.--At any
time during review of an application, the Secretary may
review such application under different processes and
procedures under clause (i), (ii), (iii), or (iv) of
paragraph (1)(B) than the processes and procedures the
sponsor elected in accordance with subparagraph (A), so
long as the Secretary proposes, in writing, the change
and the sponsor agrees, in writing, to such change.
``(C) Inclusion of ingredients in monographs.--If
the sponsor elects to use the processes and procedures
for review in accordance with clause (i) or (iii) of
paragraph (1)(B), the Secretary may incorporate any
resulting final order into a regulation addressing the
conditions under which other drugs in the same
therapeutic category are GRASE and not misbranded,
including through direct final rulemaking, and the final
order so incorporated shall cease to be effective on the
effective date of the final regulation that addresses
such drug.
``(4) Letter regarding pending applications.--Not later than
18 months after the date of enactment of the Sunscreen
Innovation Act, the Secretary shall report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, in writing, regarding all pending applications
subject to paragraph (1). In such letter, the Secretary shall
provide a report on the review of such applications, including
the timelines, in calendar days, for the review and GRASE
determination for each application. Such timelines shall account
for the considerations under paragraph (5).
``(5) Timelines.--The timelines in calendar days established
by the Secretary pursuant to this subsection--
[[Page 128 STAT. 2048]]
``(A) may vary based on the content, complexity, and
format of the application submitted to the Secretary;
and
``(B) shall--
``(i) reflect the public health priorities of
the Food and Drug Administration, including the
potential public health benefits posed by the
inclusion of additional drugs in the over-the-
counter drug monograph system;
``(ii) take into consideration the resources
available to the Secretary for carrying out such
priorities and the processes and procedures
described in paragraphs (1)(B) and (2); and
``(iii) be reasonable, taking into
consideration the requirements described in
clauses (i) and (ii).
``(b) New Time and Extent Applications.--
``(1) <<NOTE: Deadline. Regulations. Drugs and drug
abuse.>> In general.--Not later than 18 months after the date
of enactment of the Sunscreen Innovation Act, the Secretary
shall issue proposed regulations establishing timelines for the
review of applications for GRASE determinations for drugs other
than nonprescription sunscreen active ingredients or
combinations of nonprescription sunscreen active ingredients
that are submitted to the Secretary after the date of enactment
of the Sunscreen Innovation Act, under section 330.14 of title
21, Code of Federal Regulations (or any successor regulations),
and that are found to be eligible to be considered for inclusion
in the over-the-counter drug monograph system pursuant to
section 330.14 of title 21, Code of Federal Regulations (or any
successor regulations), or that are subject to this subsection
pursuant to paragraph (1) or (3) of subsection (a), as
applicable, providing--
``(A) timely and efficient completion of evaluations
of applications under section 330.14 of title 21, Code
of Federal Regulations (or any successor regulations)
for drugs other than sunscreens; and
``(B) timely and efficient completion of the review
of the safety and effectiveness submissions pursuant to
such applications, including establishing--
``(i) reasonable timelines, in calendar days,
for the applicable proposed and final regulations
for applications of various content, complexity,
and format, and timelines for internal procedures
related to such processes; and
``(ii) measurable metrics for tracking the
extent to which the timelines set forth in the
regulations are met.
``(2) Timelines.--The timelines in calendar days established
in the regulations under paragraph (1)--
``(A) may vary based on the content, complexity, and
format of the application submitted to the Secretary;
and
``(B) shall--
``(i) reflect the public health priorities of
the Food and Drug Administration, including the
potential public health benefits posed by the
inclusion of additional drugs in the over-the-
counter drug monograph system;
``(ii) take into consideration the resources
available to the Secretary for carrying out such
priorities and
[[Page 128 STAT. 2049]]
the processes and procedures described in
paragraph (1); and
``(iii) be reasonable, taking into
consideration the requirements described in
clauses (i) and (ii).
``(3) <<NOTE: Notice. Records. Time periods.>> Procedure.--
In promulgating regulations under this subsection, the Secretary
shall issue a notice of proposed rulemaking that includes a copy
of the proposed regulation, provide a period of not less than 60
calendar days for comments on the proposed regulation, and
publish the final regulation not less than 30 calendar days
before the effective date of the regulation.
``(4) <<NOTE: Regulations.>> Restrictions.--Notwithstanding
any other provision of law, the Secretary shall promulgate
regulations implementing this section only as described in
paragraphs (1), (2), and (3).
``(5) <<NOTE: Deadline.>> Final regulations.--The Secretary
shall finalize the regulations under this section not later than
27 months after the date of enactment of the Sunscreen
Innovation Act.''.
SEC. 4. REPORTS.
(a) Initial GAO Report.--Not later than 3 years after the date of
enactment of this Act, the Comptroller General of the United States
shall submit to the Committee on Health, Education, Labor, and Pensions
of the Senate and the Committee on Energy and Commerce of the House of
Representatives a report reviewing the overall progress of the Secretary
of Health and Human Services in carrying out subchapter I of chapter V
of the Federal Food, Drug, and Cosmetic Act (as added by section 2 and
amended by section 3 and subsection (c)), including findings on and
recommendations with respect to--
(1) the progress made in completing the review of requests
under subchapter I of chapter V of the Federal Food, Drug, and
Cosmetic Act, including pending requests, and the feasibility of
the timelines associated with such subchapter;
(2) the role of the Office of the Commissioner of Food and
Drugs in issuing determinations with respect to requests
reviewed under such subchapter, including the number of requests
transferred to the Office of the Commissioner under section 586C
of such Act;
(3) the extent to which advisory committees were convened by
the Secretary regarding requests under subchapter I of chapter V
of the Federal Food, Drug, and Cosmetic Act, including pending
requests; and
(4) the types of metrics that have been, or should be,
established for the review of time and extent applications.
(b) Subsequent GAO Report.--Not later than 5\1/2\ years after the
date of enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives a report reviewing the overall progress of the
Secretary of Health and Human Services in carrying out subchapter I of
chapter V of the Federal Food, Drug, and Cosmetic Act (as added by
section 2 and amended by section 3 and subsection (c)) and the
regulation of over-the-counter drug products, including findings on and
recommendations with respect to--
[[Page 128 STAT. 2050]]
(1) updates on the matters reported on by the Comptroller
General under subsection (a);
(2) significant factors impacting the ability of the Food
and Drug Administration to fulfill the mission of the agency
with regard to the regulation of over-the-counter drug products,
including finalizing outstanding monographs and responding to
emerging and novel safety issues;
(3) the performance of the Secretary in carrying out section
586E of the Federal Food, Drug, and Cosmetic Act;
(4) the types of metrics that have been, or should be,
established for the review and regulation of over-the-counter
drug products; and
(5) timeliness, efficiency, and accountability in reviewing
time and extent applications and safety and effectiveness
reviews for over-the-counter drug products.
(c) FDA Report.--Subchapter I of chapter V of the Federal Food,
Drug, and Cosmetic Act, as amended by section 3, is further amended by
adding at the end the following:
``SEC. 586G. <<NOTE: 21 USC 360fff-7.>> REPORT.
``(a) In General.--
``(1) In general.--Not later than 18 months after the date
of enactment of the Sunscreen Innovation Act, and on the dates
that are 2 and 4 years thereafter, the Secretary shall issue a
report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives describing actions taken under
this subchapter.
``(2) Contents.--The reports under this subsection shall
include--
``(A) a review of the progress made in issuing GRASE
determinations for pending requests, including the
number of pending requests--
``(i) reviewed and the decision times for each
request, measured from the date of the original
request for an eligibility determination submitted
by the sponsor;
``(ii) resulting in a determination that the
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is GRASE and is not misbranded;
``(iii) resulting in a determination that the
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is not GRASE and is misbranded and the
reasons for such determinations; and
``(iv) for which a determination has not been
made, and an explanation for the delay, a
description of the current status of each such
request, and the length of time each such request
has been pending, measured from the date of
original request for an eligibility determination
by the sponsor;
``(B) a review of the progress made in issuing GRASE
determinations for requests not included in the
reporting under subparagraph (A), including the number
of such requests--
[[Page 128 STAT. 2051]]
``(i) reviewed and the decision times for each
request;
``(ii) resulting in a determination that the
nonprescription sunscreen active ingredient,
combination of nonprescription sunscreen active
ingredients, or other ingredient is GRASE and is
not misbranded;
``(iii) resulting in a determination that the
nonprescription sunscreen active ingredient,
combination of nonprescription sunscreen active
ingredients, or other ingredient is not GRASE and
is misbranded and the reasons for such
determinations; and
``(iv) for which a determination has not been
made, and an explanation for the delay, a
description of the current status of each such
request, and the length of time each such request
has been pending, measured from the date of
original request for an eligibility determination
by the sponsor;
``(C) an annual accounting (including information
from years prior to the date of enactment of the
Sunscreen Innovation Act where such information is
available) of the total number of requests submitted,
pending, or completed under this subchapter, including
whether such requests were the subject of an advisory
committee convened by the Secretary;
``(D) a description of the staffing and resources
relating to the costs associated with the review and
decisionmaking pertaining to requests under this
subchapter;
``(E) a review of the progress made in meeting the
deadlines with respect to processing requests under this
subchapter; and
``(F) to the extent the Secretary determines
appropriate, recommendations for process improvements in
the handling of requests under this subchapter,
including the advisory committee review process.
``(b) <<NOTE: Publication. Web posting.>> Method.--The Secretary
shall publish the reports under subsection (a) in the manner the
Secretary determines to be the most effective for efficiently
disseminating the report, including publication of the report on the
Internet website of the Food and Drug Administration.''.
Approved November 26, 2014.
LEGISLATIVE HISTORY--S. 2141 (H.R. 4250):
---------------------------------------------------------------------------
HOUSE REPORTS: No. 113-558 (Comm. on Energy and Commerce) accompanying
H.R. 4250.
CONGRESSIONAL RECORD, Vol. 160 (2014):
Sept. 17, considered and passed Senate.
Nov. 13, considered and passed House.
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