[Congressional Record Volume 160, Number 138 (Thursday, November 13, 2014)]
[House]
[Pages H7959-H7964]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SUNSCREEN INNOVATION ACT
Mr. LATTA. Mr. Speaker, I ask unanimous consent to take from the
Speaker's table the bill (S. 2141) 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, and ask for its immediate consideration in the House.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Ohio?
There was no objection.
The text of the bill is as follows:
S. 2141
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. 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. 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);
``(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
[[Page H7960]]
``(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. 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. ELIGIBILITY DETERMINATIONS; DATA SUBMISSION;
FILING.
``(a) Eligibility Determinations.--
``(1) 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) notify the sponsor of the determination of the
Secretary; and
``(C) 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) 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) Filing determination.--Not later than 60 calendar
days after the submission of data and other information
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) 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) 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) 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) at the time of filing, the Secretary shall provide
written notification of such filing to the sponsor; and
``(cc) the Secretary shall make such notification publicly
available.
``(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. GRASE DETERMINATION.
``(a) 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.
``(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
[[Page H7961]]
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) 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) 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 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.
``(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) 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
``(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 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. 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) 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.
[[Page H7962]]
``(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, 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. GUIDANCE; OTHER PROVISIONS.
``(a) Guidance.--
``(1) In general.--
``(A) 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) 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) the Secretary shall review and act upon such
submissions in accordance with this subchapter.
``(b) Rules of Construction.--
``(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. SUNSCREEN MONOGRAPH.
``(a) 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 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) 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)).
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. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS.
``(a) 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) 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
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
[[Page H7963]]
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--
``(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) 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 the
processes and procedures described in paragraph (1); and
``(iii) be reasonable, taking into consideration the
requirements described in clauses (i) and (ii).
``(3) 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) 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) 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--
(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. 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;
[[Page H7964]]
``(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--
``(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) 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.''.
The bill was ordered to be read a third time, was read the third
time, and passed, and a motion to reconsider was laid on the table.
____________________