[House Report 113-558]
[From the U.S. Government Publishing Office]
113th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 113-558
======================================================================
SUNSCREEN INNOVATION ACT
_______
July 24, 2014.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 4250]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4250) 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, having considered the same,
report favorably thereon with an amendment and recommend that
the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 8
Background and Need for Legislation.............................. 8
Hearings......................................................... 9
Committee Consideration.......................................... 9
Committee Votes.................................................. 9
Committee Oversight Findings..................................... 10
Statement of General Performance Goals and Objectives............ 10
New Budget Authority, Entitlement Authority, and Tax Expenditures 10
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 10
Committee Cost Estimate.......................................... 10
Congressional Budget Office Estimate............................. 10
Federal Mandates Statement....................................... 12
Duplication of Federal Programs.................................. 12
Disclosure of Directed Rule Makings.............................. 12
Advisory Committee Statement..................................... 12
Applicability to Legislative Branch.............................. 12
Section-by-Section Analysis of the Legislation................... 12
Changes in Existing Law Made by the Bill, as Reported............ 19
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Sunscreen Innovation Act''.
SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE INGREDIENTS.
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 Active Ingredients
``SEC. 586. DEFINITIONS.
``In this subchapter:
``(1) The term `Advisory Committee' means the Nonprescription
Drug Advisory Committee or any successor to such Committee.
``(2) The terms `generally recognized as safe and effective'
and `GRASE' mean 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
product's labeling, as described in section 201(p).
``(3) The term `GRASE determination' means, with respect to a
nonprescription sunscreen active ingredient or a combination of
nonprescription sunscreen active ingredients, a determination
of whether such ingredients or combination of ingredients is
generally recognized as safe and effective and not misbranded
for use under the conditions prescribed, recommended, or
suggested in the product's labeling, as described in section
201(p).
``(4) The term `nonprescription' means not subject to section
503(b)(1).
``(5) The term `pending request' means each request submitted
to the Secretary--
``(A) for consideration for inclusion in the over-
the-counter drug monograph system;
``(B) that was deemed eligible for such review by
publication of a notice of eligibility in the Federal
Register prior to the date of enactment of the
Sunscreen Innovation Act; and
``(C) for which safety and effectiveness data has
been submitted to the Secretary prior to such date of
enactment.
``(6) The term `sponsor' means the person submitting the
request under section 586A(a), including a time and extent
application under section 586B, or the person that submitted
the pending request.
``(7) 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
radiation.
``(8) The term `sunscreen' means a product containing one or
more sunscreen active ingredients.
``SEC. 586A. GENERAL PROVISIONS.
``(a) 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 generally
recognized as safe and effective and not misbranded.
``(b) Rules of Construction.--
``(1) Currently marketed sunscreens.--Nothing in this
subchapter shall be construed to affect the marketing of
sunscreens that are lawfully marketed in the United States on
or before the date of enactment of this subchapter.
``(2) Ensuring safety and effectiveness.--Nothing in this
subchapter shall be construed to alter the Secretary's
authority to prohibit the marketing of a sunscreen that is not
safe and effective or to impose restrictions on the marketing
of a sunscreen to ensure safety and effectiveness.
``(3) Other products.--Nothing in this subchapter shall be
construed to affect the Secretary's regulation of products
other than sunscreens.
``(c) Sunset.--This subchapter shall cease to be effective at the end
of the 5-year period beginning on the date of enactment of this
subchapter.
``SEC. 586B. ELIGIBILITY DETERMINATION.
``(a) In General.--Upon receipt of a request under section 586A(a),
not later than 60 days after the date of receipt of such request, the
Secretary shall--
``(1) determine whether the request is eligible for further
review under sections 586C and 586D, as described in subsection
(b);
``(2) notify the sponsor of the Secretary's determination;
and
``(3) make such determination publicly available in
accordance with subsection (c).
``(b) Criteria for Eligibility.--
``(1) In general.--To be eligible for review under sections
586C and 586D, 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--
``(A) is not included in the stayed sunscreen
monograph in part 352 of title 21, Code of Federal
Regulations; and
``(B) has been used to a material extent and for a
material time, as described in section 201(p)(2).
``(2) Time and extent application.--A sponsor shall include
in a request under section 586A(a) a time and extent
application including all the information required to meet the
standard described in paragraph (1)(B).
``(c) Public Availability.--
``(1) Redactions for confidential information.--If a
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients is determined to
be eligible for further review under subsection (a)(1), 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.
``(2) Identification of confidential information by
sponsor.--Sponsors shall identify any information which the
sponsor considers to be confidential information described in
paragraph (1).
``(3) Confidentiality during eligibility review.--The
information contained in a request under section 586A(a) shall
remain confidential during the Secretary's consideration under
this section of whether the request is eligible for further
review.
``SEC. 586C. DATA SUBMISSION; FILING DETERMINATION.
``(a) In General.--In the case of a request under section 586A(a)
that is determined to be eligible under section 586B for further review
under this section and section 586D--
``(1) the Secretary shall, in notifying the public under
section 586B(a)(3) of such eligibility determination, invite
the sponsor of the request and any other interested party to
submit, in support of or otherwise relating to a GRASE
determination--
``(A) published and unpublished data and other
information related to the safety and effectiveness of
the nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients for its intended nonprescription uses; or
``(B) any other comments; and
``(2) not later than 60 days after the submission of such
data and other information by the sponsor, including any
revised submission of such data and other information following
a refusal to file under subparagraph (B), the Secretary shall--
``(A)(i) issue a written notification to the sponsor
determining that the request under section 586A(a),
together with such data and other information, is
sufficiently complete to conduct a substantive review
and make such notification publicly available; and
``(ii) file such request; or
``(B) issue a written notification to the sponsor
refusing to file the request and stating the reasons
for the refusal and why the data and other information
submitted is not sufficiently complete to conduct a
substantive review and make such notification publicly
available;
``(3) the Secretary shall, in filing a request under
paragraph (2)--
``(A) invite the public to submit further comments
with respect to such filing; and
``(B) limit such public comment, and the comment
period under paragraph (1), to the period ending on the
date that is 60 days after such filing;
``(4) if the Secretary refuses to file the request--
``(A) the sponsor may, within 30 days of receipt of
written notification of such refusal, seek a meeting
with the Secretary regarding whether the Secretary
should file the request; and
``(B) the Secretary shall convene the meeting; and
``(5) following any such meeting--
``(A) if the sponsor asks that the Secretary file the
request (with or without amendments to correct any
purported deficiencies to the request) the Secretary
shall file the request over protest, issue a written
notification of the filing to the sponsor, and make
such notification publicly available; and
``(B) if the request is so filed over protest, the
Secretary shall not require the sponsor to resubmit a
copy of the request for purposes of such filing.
``(b) Reasons for Refusal to File Request.--The Secretary may refuse
to file a request submitted under section 586A(a) if the Secretary
determines the data or other information submitted by the sponsor under
this section are not sufficiently complete to conduct a substantive
review with respect to such request.
``(c) Public Availability.--
``(1) Redactions for confidential information.--The Secretary
shall make data and other information submitted in connection
with a request under section 586A(a) 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.
``(2) Identification of confidential information by
sponsor.--Sponsors or any other individual submitting data or
other information under this section shall identify any
information which the sponsor or individual considers to be
confidential information described in paragraph (1).
``SEC. 586D. GRASE DETERMINATION.
``(a) Review of New Request.--
``(1) Proposed order by cder.--In the case of a request under
section 586A(a), the Director of the Center for Drug Evaluation
and Research shall--
``(A) not later than 300 days after the date on which
the request is filed under section 586C(a), complete
the review of the request and issue a proposed order
determining that--
``(i) the nonprescription sunscreen active
ingredient or combination of nonprescription
sunscreen active ingredients that is the
subject of the request--
``(I) is GRASE; and
``(II) is not misbranded;
``(ii) the nonprescription sunscreen active
ingredient or combination of nonprescription
sunscreen active ingredients that is the
subject of the request--
``(I) is not GRASE; or
``(II) is misbranded; or
``(iii) additional information is necessary
to allow the Director of the Center for Drug
Evaluation and Research to complete the review
of such request;
``(B) within such 300-day period, convene a meeting
of the Advisory Committee to review the request under
section 586A(a): and
``(C) if the Director fails to issue such proposed
order within the 300-day period referred to in
subparagraph (A), transmit the request to the
Commissioner of Food and Drugs for review.
``(2) Proposed order by commissioner.--With respect to a
request transmitted to the Commissioner of Food and Drugs under
paragraph (1)(C), the Commissioner shall, not later than 60
days after the date of such transmission, issue--
``(A) a proposed order described in paragraph
(1)(A)(i);
``(B) a proposed order described in paragraph
(1)(A)(ii); or
``(C) a proposed order described in paragraph
(1)(A)(iii).
``(3) Publication in federal register; public comment
period.--A proposed order issued under paragraph (1) or (2)
with respect to a request shall--
``(A) be published in the Federal Register; and
``(B) solicit public comments for a period of not
more than 45 days.
``(4) Final order by cder.--In the case of a proposed order
under paragraph (1)(A) or (2) with respect to a request, the
Director of the Center for Drug Evaluation and Research shall--
``(A) issue a final order with respect to the
request--
``(i) in the case of a proposed order under
clause (i) or (ii) of paragraph (1)(A) or
subparagraph (A) or (B) of paragraph (2), not
later than 90 days after the end of the public
comment period under paragraph (3)(B); or
``(ii) in the case of a proposed order under
paragraph (1)(A)(iii) or paragraph (2)(C), not
later than 210 days after the date on which the
sponsor submits the additional information
requested pursuant to such proposed order; or
``(B) if the Director fails to issue such final order
within such 90- or 210-day period, as applicable,
transmit such proposed order to the Commissioner of
Food and Drugs for review.
``(5) Final order by commissioner.--With respect to a
proposed order transmitted to the Commissioner of Food and
Drugs under paragraph (4)(B), the Commissioner shall issue a
final order with respect to such proposed order not later than
60 days after the date of such transmission.
``(b) Review of Pending Requests.--
``(1) In general.--The review of a pending request shall be
carried out by the Director of the Center for Drug Evaluation
and Research in accordance with paragraph (3).
``(2) Inapplicability of certain provisions.--Sections 586B
and 586C shall not apply with respect to any pending request.
``(3) Proposed order by cder.--The Director of the Center for
Drug Evaluation and Research shall--
``(A) within the timeframe applicable under paragraph
(4), complete the review of the request and issue a
proposed order determining that--
``(i) the nonprescription sunscreen active
ingredient or combination of nonprescription
sunscreen active ingredients that is the
subject of the pending request--
``(I) is GRASE; and
``(II) is not misbranded;
``(ii) the nonprescription sunscreen active
ingredient or combination of nonprescription
sunscreen active ingredients that is the
subject of the pending request--
``(I) is not GRASE; or
``(II) is misbranded; or
``(iii) additional information is necessary
to allow the Director of the Center for Drug
Evaluation and Research to complete the review
of the pending request; and
``(B) if the Director fails to issue such proposed
order within the timeframe applicable under paragraph
(4), transmit the pending request to the Commissioner
of Food and Drugs for review.
``(4) Timeframe for issuance of proposed order by cder.--The
Director of the Center for Drug Evaluation and Research shall
issue a proposed order, as required by paragraph (3)(A)--
``(A) in the case of a pending request for which the
Food and Drug Administration has issued a feedback
letter before the date of enactment of the Sunscreen
Innovation Act, not later than 45 days after such date
of enactment; and
``(B) in the case of a pending request for which the
Food and Drug Administration has not issued a feedback
letter before the date of enactment of the Sunscreen
Innovation Act, not later than 90 days after such date
of enactment.
``(5) Proposed order by commissioner.--With respect to a
pending request transmitted to the Commissioner of Food and
Drugs under paragraph (3)(B), the Commissioner shall, not later
than 60 days after the date of such transmission, issue--
``(A) a proposed order described in paragraph
(3)(A)(i);
``(B) a proposed order described in paragraph
(3)(A)(ii); or
``(C) a proposed order described in paragraph
(3)(A)(iii).
``(6) Publication in federal register; public comment
period.--A proposed order issued under paragraph (3) or (5)
with respect to a pending request shall--
``(A) be published in the Federal Register; and
``(B) solicit public comments for a period of not
more than 45 days.
``(7) Advisory committee.--For a proposed order issued under
paragraph (3)(A)(iii) or (5)(C) requesting additional
information, an Advisory Committee meeting shall be convened if
the sponsor requests, or the Director of the Center for Drug
Evaluation and Research or the Commissioner of Food and Drugs
decides, to convene such a meeting for the purpose of reviewing
the pending request.
``(8) Final order by cder.--In the case of a proposed order
under paragraph (3)(A) or (5) with respect to a request, the
Director of the Center for Drug Evaluation and Research shall--
``(A) issue a final order with respect to the
request--
``(i) in the case of a proposed order under
clause (i) or (ii) of paragraph (3)(A) or
subparagraph (A) or (B) of paragraph (5), not
later than 90 days after the end of the public
comment period under paragraph (3)(B); or
``(ii) in the case of a proposed order under
paragraph (3)(A)(iii) or paragraph (5)(C)--
``(I) if the Advisory Committee is
not convened pursuant to paragraph (7),
not later than 210 days after the date
on which the sponsor submits the
additional information requested
pursuant to such proposed order; or
``(II) if the Advisory Committee is
convened pursuant to paragraph (7), not
later than 270 days after date on which
the sponsor submits such additional
information; or
``(B) if the Director fails to issue such final order
within such 90-, 210-, and 270-day period, as
applicable, transmit such proposed order to the
Commissioner of Food and Drugs for review.
``(9) Final order by commissioner.--With respect to a
proposed order transmitted to the Commissioner of Food and
Drugs under paragraph (8)(B), the Commissioner shall issue a
final order with respect to such proposed order not later than
60 days after the date of such transmission.
``(c) Advisory Committee.--
``(1) Limitations.--The Food and Drug Administration--
``(A) shall not be required to convene the Advisory
Committee--
``(i) more than once with respect to any
request under section 586A(a) or any pending
request; or
``(ii) more than twice in any twelve month
period with respect to the review of
submissions under this section; and
``(B) shall not be required to submit more than 3
submissions to the Advisory Committee per meeting.
``(2) Membership.--In appointing the members of the Advisory
Committee, the Secretary may select to serve temporarily as
voting members on the Advisory Committee--
``(A) members of other Federal advisory committees;
or
``(B) consultants from outside of the Department of
Health and Human Services who have substantive
expertise regarding sunscreen active ingredients.
``(d) No Delegation.--Any responsibility vested by this section in
the Commissioner of Food and Drugs is not delegable.
``(e) Effect of Final Order.--
``(1) Content.--A final order under subsection (a)(4),
(a)(5), (b)(8), or (b)(9) with respect to a request under
section 586A(a) or a pending request shall determine that the
nonprescription sunscreen active ingredient or combination of
nonprescription sunscreen active ingredients that is the
subject of the request--
``(A) is GRASE and is not misbranded; or
``(B) is not GRASE or is misbranded.
``(2) Active ingredients determined to be grase.--Upon
issuance of a final order determining that a nonprescription
sunscreen active ingredient or combination of nonprescription
sunscreen active ingredients is GRASE and is not misbranded,
the active ingredient or combination of active ingredients
shall be permitted to be introduced or delivered into
interstate commerce, for use under the conditions subject to
the final order, in accordance with all requirements applicable
to drugs not subject to section 503(b)(1).
``(3) Active ingredients determined not to be grase.--Upon
issuance of a final order determining that the nonprescription
sunscreen active ingredient or combination of nonprescription
sunscreen active ingredients is not GRASE or is misbranded, the
active ingredient or combination of active ingredients shall
not be introduced or delivered into interstate commerce, for
use under the conditions subject to the final order, unless an
application submitted pursuant to section 505(b) with respect
to such active ingredient or combination of active ingredients
is approved.
``SEC. 586E. REPORTS.
``(a) GAO Report.--Not later than 1 year after the date of enactment
of the Sunscreen Innovation Act, the Comptroller General of the United
States shall--
``(1) submit a report reviewing the overall progress of the
Secretary in carrying out this subchapter to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives; and
``(2) include findings on--
``(A) the progress made in completing the review of
pending requests; and
``(B) the role of the Office of the Commissioner of
Food and Drugs in issuing determinations with respect
to pending requests, including the number of requests
transferred to the Office of the Commissioner under
section 586D.
``(b) Secretary's Report.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Sunscreen Innovation Act, and every 2 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 section.
Each report under this subsection shall be posted on the
Internet site of the Food and Drug Administration.
``(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 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, 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 in a
timely manner GRASE determinations for requests
submitted under section 586A(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 or
combination of nonprescription sunscreen active
ingredients is GRASE and 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, 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) a description of the staffing and resources
relating to the costs associated with the review and
decisionmaking pertaining to requests under this
subchapter;
``(D) a review of the progress made in meeting the
deadlines with respect to processing requests under
this subchapter;
``(E) to the extent the Secretary determines
appropriate, recommendations for process improvements
in the handling of pending and new requests, including
the advisory committee review process; and
``(F) recommendations for expanding the applicability
of this subchapter to nonprescription active
ingredients that are not related to the sunscreen
category of over-the-counter drugs.
``(c) Method.--The Secretary shall publish the reports required under
subsection (b) 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.''.
SEC. 3. GUIDANCE.
(a) In General.--
(1) Issuance.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall issue guidance, in accordance with good guidance
practices, on the implementation of, and compliance with,
subchapter I of chapter V of the Federal Food, Drug, and
Cosmetic Act, as added by section 2, including guidance on--
(A) the criteria for determining whether a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients has been used to a material extent and for
a material time, as described in section 201(p)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321(p)(2));
(B) the format and content of a safety and
effectiveness data submission; and
(C) the safety and efficacy standards for determining
whether a nonprescription sunscreen active ingredients
or combination of nonprescription sunscreen active
ingredients is generally recognized as safe and
effective, as defined in section 586 of such subchapter
I.
(2) 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.
(b) Submissions Pending Issuance of Final Guidance.--Irrespective of
whether final guidance under subsection (a) has been issued--
(1) persons may, beginning on the date of enactment of this
Act, make submissions under subchapter I of chapter V of the
Federal Food, Drug, and Cosmetic Act, as added by section 2;
and
(2) the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall review and
act upon such submissions in accordance with such subchapter.
Purpose and Summary
H.R. 4250, the ``Sunscreen Innovation Act,'' would address
the current backlog of applications for nonprescription
sunscreen active ingredients pending at the Food and Drug
Administration (FDA), as well as establish a predictable and
transparent review process for new applications, incorporating
meaningful input from experts and the public.
Background and Need for Legislation
Skin cancer is a public health crisis in the United States.
Each year there are more new cases of skin cancer than the
combined incidence of breast, prostate, lung, and colon
cancer.\1\ By 2015, it is estimated that one in fifty Americans
will develop melanoma in their lifetime.\2\
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\1\Cancer Facts and Figures 2014, American Cancer Society http://
www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-
042151.pdf.
\2\Rigel DS, Russak J, Friedman R. The evolution of melanoma
diagnosis: 25 years beyond the ABCDs. CA Cancer J Clin. 2010 Sep-Oct;
60(5): 301-16.
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The FDA has not approved a new nonprescription sunscreen
ingredient through the monograph process in nearly two decades,
despite the fact that several applications have been pending at
the agency for years. The FDA has listed action on sunscreen
ingredient applications as a priority since 2008 in the Unified
Agenda; however, no new sunscreen ingredients have received a
decision from FDA. The pre-existing time and extent application
(TEA) process did not include deadlines for the timely review
of such ingredients, which this bill would establish. Further,
it would remove administrative hurdles identified by FDA to the
sunscreen approval process and ensure sunscreens receive a
transparent review within a predictable timeframe.
H.R. 4250 does not independently address FDA's review of
sunscreen products with sun protection factor (SPF) values
higher than 50 and the labeling thereof. However, FDA recently
published a proposed rule that would limit the maximum SPF
value on nonprescription product labeling to ``50+,'' unless
FDA were to receive data demonstrating that products with SPF
values higher than 50 provide additional clinical benefit. In
the proposed rule, FDA recommended that anyone interested in
conducting studies to develop such data should contact FDA
before beginning the studies. The Committee understands that at
least two organizations have responded to this recommendation
by submitting a clinical protocol to FDA describing how,
together, they would conduct a study to demonstrate the
clinical benefit of SPF 50+ sunscreen products. The Committee
also understands that, as of yet, FDA has not provided a
response to the submitting organizations.
Such products could protect consumers from harmful
exposure. To ensure that a final rule on this issue is informed
by the most recent and best available scientific data, the
Committee expects FDA to respond in a timely manner to any
suggested clinical protocols FDA may have received in response
to the offer the agency made in its 2011 proposed rule.
Hearings
The Subcommittee on Health, held a hearing on H.R. 4250 on
April 7, 2014. The Subcommittee received testimony from:
Dr. Janet Woodcock, Director, Center for
Drug Evaluation and Research;
Mr. Joseph T. Rannazzisi, Deputy Assistant
Administrator, Office of Diversion Control, Drug
Enforcement Administration;
Dr. Nathan B. Fountain, Chair, Medical
Advisory Board, Epilepsy Foundation;
Mr. John M. Gray, President and CEO,
Healthcare Distribution Management Association;
Mr. Linden D. Barber, Partner and Director,
DEA Compliance Operations, Quarles & Brady;
Ms. Wendy K.D. Selig, President and CEO
Melanoma Research Alliance; and,
Mr. Scott Faber, Vice President, Government
Affairs, Environmental Working Group.
Committee Consideration
On June 19, 2014, the Subcommittee on Health met in open
markup session and forwarded H.R. 4250 to the full Committee
consideration, as amended, by a voice vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no recorded votes taken in connection with ordering
H.R. 4250 reported. A motion by Mr. Upton to order H.R. 4250
reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held a hearing and made
findings that are reflected in this report.
Statement of General Performance Goals and Objectives
H.R. 4250 would establish a predictable and timely review
process for pending and new sunscreen ingredient applications.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
4250 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the Rules of the House of Representatives, the Committee
finds that H.R. 4250 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 23, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 4250, the
Sunscreen Innovation Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Ellen Werble.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 4250--Sunscreen Innovation Act
Summary: H.R. 4250 would modify the review process that
allows the marketing of certain new ingredients in non-
prescription sunscreen based on a determination by the Food and
Drug Administration (FDA) that they are generally recognized as
safe and effective. CBO estimates that implementing H.R. 4250
would cost $28 million over the 2015-2019 period, assuming
appropriation of the necessary amounts. H.R. 4250 would not
affect direct spending or revenues; therefore, pay-as-you-go
procedures do not apply.
H.R. 4250 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA).
The bill would impose private-sector mandates, as defined
in UMRA, because it would allow FDA to require that marketing
applications for certain sunscreen products be submitted in a
new standardized format. CBO estimates that the direct cost of
complying with those requirements would not exceed the annual
threshold established by UMRA for private-sector mandates ($152
million in 2014, adjusted annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary effect of H.R. 4250 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2015 2016 2017 2018 2019 2015-2019
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level........................... 4 5 7 7 9 32
Estimated Outlays....................................... 3 4 6 7 8 28
----------------------------------------------------------------------------------------------------------------
Basis of estimate: For this estimate, CBO assumes that H.R.
4250 will be enacted near the beginning of fiscal year 2015,
that the necessary amounts will be appropriated for each year,
and that outlays will follow historical spending patterns for
similar activities.
Drugs marketed in the United States generally must be
tested for safety and efficacy and approved by FDA through an
application process. However, certain products currently are
marketed under a determination by FDA that they are generally
recognized as safe and effective and have been marketed for a
specific time and extent under the conditions of their
labeling. Under current law, non-prescription sunscreen
products are marketed under such a determination and are
subject to a multistep process that involves scientific review
and notice-and-comment rulemaking by FDA.
H.R. 4250 would change the process for reviewing certain
new drug ingredients in non-prescription sunscreen by FDA. In
addition, the bill would require that the agency adhere to
specific timelines and issue administrative orders. Based on
information provided by FDA, CBO estimates that implementing
the bill would cost $28 million over the 2015-2019 period,
assuming appropriation of the necessary amounts.
Pay-As-You-Go considerations: None.
Estimated impact on state, local, and tribal governments:
H.R. 4250 contains no intergovernmental mandates as defined in
UMRA and would impose no costs on state, local, or tribal
governments.
Estimated impact on the private sector: H.R. 4250 would
impose a mandate on firms seeking to market certain new active
ingredients for sunscreen by giving FDA the authority to modify
the format of marketing applications. Under current law, FDA
can refuse to allow marketing of a sunscreen product if the
agency finds that the sponsor does not provide sufficient data
to demonstrate that the product is generally recognized as safe
and effective. However, FDA currently cannot require that
applicants submit their applications in a standardized format.
Such lack of uniformity can slow down the review process. Under
H.R. 4250, FDA would have the authority to impose and enforce a
standard format on such applications. The number of
applications for new sunscreen ingredients is low in any given
year, and the additional cost to each sponsor of complying with
the new requirements would be low as well. Therefore, CBO
expects that the cost of complying with this new requirement
would not exceed the threshold defined in UMRA ($152 million in
2014, adjusted annually for inflation) in any of the first five
years following enactment.
Estimate prepared by: Federal costs: Ellen Werble; Impact
on state, local, and tribal governments: J'nell L. Blanco;
Impact on the private sector: Kyle Redfield.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Duplication of Federal Programs
No provision of H.R. 4250 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program, a program that was included in any
report from the Government Accountability Office to Congress
pursuant to section 21 of Public Law 111-139, or a program
related to a program identified in the most recent Catalog of
Federal Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that enacting H.R. 4250 does not
specifically direct any specific rule making within the meaning
of 5 U.S.C. 551.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides a short title of ``Sunscreen Innovation
Act.''
Section 2. Regulation of nonprescription sunscreen active ingredients
Section 2 amends the Federal Food, Drug, and Cosmetic Act
by adding a new subchapter: ``Subchapter I. Nonprescription
Sunscreen Active Ingredients.'' An analysis of the new
subchapter is provided below.
Section 586. Definitions
This section provides definitions for terms used in the
legislation.
Among other technical definitions that are consistent with
existing statutory and regulatory definitions, this section
defines ``pending request'' as requests that were submitted and
deemed eligible for a safety and effectiveness review by the
FDA and for which the sponsor has submitted safety and
effectiveness data to FDA prior to the date of enactment.
This section designates the existing ``Nonprescription Drug
Advisory Committee'' (NDAC) as the advisory committee that may
be convened under this subchapter.
This section defines ``GRASE determination'' as a
determination of whether the sunscreen active ingredient or
combination of sunscreen active ingredients that is the subject
of a request under this subchapter is generally recognized as
safe and effective (GRASE) and not misbranded.
Section 586A. General Provisions
(a) Requests
This section provides an opportunity for sponsors to
request from the Secretary a determination as to whether a
nonprescription active ingredient or a combination of sunscreen
active ingredients for use under specified conditions is GRASE
and not misbranded.
(b) Rules of construction
Sunscreen products which are lawfully marketed in the U.S.
on or before the date of enactment are not subject to the
review process created by this legislation. The Secretary's
authority to prohibit marketing of a sunscreen that is not safe
and effective or to impose restrictions on the marketing of a
sunscreen to ensure safety and effectiveness is not affected by
this legislation. This section specifies that the review
process created by this legislation does not apply to the
review of drug products other than sunscreen.
(c) Sunset
The provisions of the Sunscreen Innovation Act will sunset
on a date five years from the date of enactment. The subsection
makes clear that any request submitted before the date of
sunset must continue to be reviewed under the Sunscreen
Innovation Act (SIA) process.
Section 586B. Eligibility determination
This section sets out the process by which the Secretary
determines that a sunscreen active ingredient or combination of
sunscreen active ingredients has been marketed for a material
time and to a material extent, and therefore, is eligible to be
reviewed for a GRASE determination by the Secretary.
(a) In general
The Secretary shall act on a sunscreen request under
Section 586A(a) no later than 60 days after the receipt of such
a request, by determining whether the request is eligible for a
safety and effectiveness review.
(b) Criteria for eligibility
To be eligible for a safety and effectiveness review, a
sunscreen active ingredient or combination of sunscreen active
ingredients must not be included on the stayed monograph and
must have been marketed for a material time and to a material
extent, as established by the information included in its
request under Section 586A(a).
(c) Public availability
Requests under this Act will remain confidential during
FDA's consideration of eligibility. The request will be
published only if FDA determines that the condition is eligible
for review of safety and effectiveness data. However,
confidential or proprietary information will be redacted from
the public record in accordance with existing law.
Section 586C. Data submission; Filing determination
(a) In general
In the case of a request that is determined by FDA to be
eligible for safety and effectiveness review, FDA shall include
in the public notice of eligibility a request for the
submission of comments and of published and unpublished data
related to the safety and effectiveness of the sunscreen active
ingredient or combination of sunscreen active ingredients for
its intended use.
Once a sponsor has submitted its safety and effectiveness
data package, FDA has 60 days to issue a written filing
determination regarding whether the data and other information
submitted by the sponsor is sufficiently complete for FDA to
conduct a substantive review and either file the request or
refuse to file the request. If FDA refuses to file the request,
it must provide the sponsor with a justification for refusing
to file the request, including an explanation of why the data
submitted is not sufficiently complete to conduct a substantive
review.
If FDA files the request, FDA shall invite the public to
submit further comments within 60 days of the filing date.
If FDA refuses to file the request, the sponsor may, within
30 days, seek a meeting with the Secretary regarding the
refusal. The Secretary is authorized to file the request over
protest at the request of the applicant.
The Committee expects that FDA and the applicant will work
together so that appropriate safety and effectiveness data is
submitted.
(b) Reasons for refusal to file request
This subsection defines the standard under which FDA may
refuse to file. FDA may refuse to file if the data package
submitted by the sponsor is not sufficiently complete for FDA
to conduct a substantive review with respect to the request.
(c) Public availability
This subsection protects confidential or proprietary
information contained within a data package submitted by a
sponsor or any other person. Such confidential information will
be redacted from the public record, in accordance with existing
law.
Section 586D. GRASE determination
This section provides processes for FDA to conduct a safety
and effectiveness review for both new and pending requests.
(a) Review of new requests
This subsection provides a description of the process by
which FDA will review new requests submitted under section 586A
after the date of enactment.
(1) Proposed order by CDER
FDA's Center for Drug Evaluation and Research (CDER) has
300 days from the date FDA files a request under Section 586C
to make an initial GRASE determination or a determination that
additional information is needed to make such GRASE
determination. CDER must issue a proposed order articulating
such initial determination.
Within the 300-day period, CDER is required to convene the
NDAC to review the request and provide advice and
recommendations, unless the sponsor and CDER agree that the
advisory committee is not necessary.
(2) Proposed order by Commissioner
Should CDER fail to issue a proposed order within 300 days,
the request must be submitted to the FDA Commissioner
(Commissioner) for review, and within 60 days, the Commissioner
must issue a proposed order. The Committee expects CDER to
issue the proposed order within 300 days and that referral to
the Commissioner will not be necessary. However, if such
referral is made, the Commissioner must act within 60 days.
(3) Publication in Federal Register; Public comment
period
The proposed order shall be published in the Federal
Register, and include a public comment period of not more than
45 days.
(4) Final order by CDER
This paragraph provides timelines for the issuance of a
final order containing a final GRASE determination after
consideration of public comments and/or any required additional
data.
In the case of a proposed order that contained an initial
determination that the sunscreen active ingredient or
combination of sunscreen active ingredients is GRASE and not
misbranded, or an initial determination that the sunscreen
active ingredient or combination of sunscreen active
ingredients is not GRASE and is misbranded, this paragraph
requires CDER to publish a final order not later than 90 days
after the end of the 45-day comment period.
In the case of an initial determination that additional
data and information is needed to determine whether the
sunscreen active ingredient or combination of sunscreen active
ingredients is GRASE and not misbranded, this paragraph
requires CDER to publish a final order not later than 210 days
after the sponsor submits additional data and information to
support its request.
(5) Final order by Commissioner
This paragraph provides that if CDER fails to issue a final
order within the 90-day or 210-day periods described in
subsection (4), the request must be submitted to the
Commissioner and within 60 days the Commissioner must issue a
final order. Again, the Committee expects CDER to issue the
final order and that referral to the Commissioner will not be
necessary. However, if such referral is made, the Commissioner
must act within 60 days.
(b) Review of pending requests
This subsection provides a description of the process by
which FDA will review ``pending requests,'' as defined in the
legislation.
(1) In general
This paragraph requires FDA to carry out the review of a
pending request in accordance with paragraph (3) below.
(2) Inapplicability of certain provisions
This paragraph makes clear that pending requests will not
be subject to an eligibility determination (section 586B) or a
filing determination (section 586C) because these requests
already have been determined by FDA to be eligible prior to the
date of enactment.
(3) Proposed order by CDER
CDER shall make an initial GRASE determination or a
determination that additional information is needed to make
such determination. CDER must issue a proposed order
articulating such GRASE determination.
(4) Timeframe for issuance of proposed order by CDER
CDER shall issue a proposed order within 45 days of
enactment of this legislation for pending requests for which
FDA has issued a feedback letter before enactment. For pending
requests for which FDA has not issued a feedback letter before
enactment, CDER must issue a proposed order within 90 days of
enactment.
(5) Proposed order by Commissioner
In the event that CDER does not issued a proposed order
within the 45-day or 90-day required timeframes, this paragraph
requires that the request be submitted to the Commissioner for
review, and within 60 days, the Commissioner must issue a
proposed order. The Committee expects CDER to issue the
proposed order and that referral to the Commissioner will not
be necessary. However, if such referral is made, the
Commissioner must act within 60 days.
(6) Publication in Federal Register; Public comment
period
This paragraph requires that the proposed order for pending
requests be published in the Federal Register and include a
public comment period of not more than 45 days.
(7) Advisory committee
In the case of a proposed order determining that additional
information is needed to make a GRASE determination, this
paragraph provides that the NDAC shall be convened if the
sponsor, at the time of submission of additional information,
requests it to be convened, or if CDER decides to convene it.
(8) Final order by CDER
This paragraph provides timelines for the issuance of a
final order containing a final GRASE determination after
consideration of public comments and/or any required additional
data.
In the case of an active ingredient or combination of
active ingredients subject to a proposed order that contains an
initial determination that the sunscreen active ingredient or
combination of sunscreen active ingredients is GRASE and not
misbranded or an initial determination that the sunscreen
active ingredient or combination of sunscreen active
ingredients is not GRASE and is misbranded, CDER must publish a
final order not later than 90 days after the end of the 45-day
comment period.
In the case of an active ingredient or combination of
active ingredients subject to a proposed order that contains a
determination that additional data and information is needed to
make a GRASE determination, CDER must publish a final order not
later than 210 days after the sponsor submits additional data
and information to support its request. However, in the case
that an advisory committee is convened under paragraph (7)
above, this paragraph provides CDER with 270 days from the
submission of additional data to issue the final order.
(9) Final order by Commissioner
If CDER fails to issue a final order within the 210-day or
270-day periods described in subsection (8), the request must
be submitted to the Commissioner and within 60 days the
Commissioner must issue a final order. Again, the Committee
expects CDER to issue the final order and that referral to the
Commissioner will not be necessary. However, if such referral
is made, the Commissioner must act within 60 days.
(c) Advisory Committee
(1) Limitations
This paragraph provides that FDA shall not be required to
convene the NDAC (A) more than once with respect to any new or
pending request, or (B) more than twice in any 12-month period
with respect to review of submissions under this section, and
(C) shall not be required to submit more than 3 submissions to
the advisory committee per meeting. The Committee intends for
FDA to strive to consider all applications in coordination with
NDAC in a timely fashion and within statutory deadlines to
ensure sunscreen ingredients receive a timely review to meet
the pressing public health need for these new ingredients.
(2) Membership
FDA is permitted to augment the NDAC by appointing as
temporary members relevant experts and consultants with
substantive expertise related to the evaluation of the safety
and effectiveness of sunscreen active ingredients.
(d) No delegation
This subsection prohibits delegation of the responsibility
invested in the Commissioner to issue proposed and final rules
under this legislation.
(e) Effect of final order
(1) Content
A final order issued under this legislation must include a
final GRASE determination.
(2) Active ingredients determined to be GRASE
Upon issuance of a final order determining that the
sunscreen active ingredient or combination of sunscreen active
ingredients is GRASE and not misbranded, the sunscreen active
ingredient or combination of sunscreen active ingredients may
be introduced or delivered into commerce, for use under
conditions subject to the final order and in accordance with
all applicable FDA requirements.
(3) Active ingredients determined not to be GRASE
If FDA issues a final order determining that the sunscreen
active ingredient or combination of sunscreen active
ingredients is not GRASE and is misbranded, the sunscreen
active ingredient or combination of sunscreen active
ingredients may not be introduced or delivered into commerce
unless it has been approved under a new drug application.
Section 586E. Reports
To help ensure accountability for meeting the deadlines set
forth in the legislation and to gather information about FDA's
implementation of the review process, Congress included two
reporting requirements in the Act.
(a) GAO report
The Comptroller General of the United States is required to
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 not later than 1 year after the date of
enactment of the Act, demonstrating the overall progress of FDA
in implementing the legislation, focusing on the progress made
with respect to pending requests and the role played by the
Commissioner in ensuring timely issuance of proposed and final
orders.
(b) Secretary's report
This subsection requires FDA to 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
not later than 2 years after the date of enactment of the Act,
and every 2 years thereafter, demonstrating actions taken under
the Act. The report must include specific information detailed
in Section 586E(b)(2). For example, FDA must describe its
progress in meeting the deadlines set out in the Act, an
accounting of the number of requests reviewed under the Act and
the decision times associated with such reviews, the number of
requests that remain pending and the amount of time they have
been pending (measured from the date of original submission),
and a description of the staffing and resources relating to
this process. The reports are to be made publically available.
Section 3. Guidance
(a) In General
FDA is required to issue guidance that includes (A) the
criteria for determining whether a nonprescription sunscreen
active ingredient or a combination of nonprescription sunscreen
active ingredients has been marketed to a material extent and
for a material time, (B) the format and content of a safety and
effectiveness data submission, and (C) the safety and
effectiveness standards for determining whether a
nonprescription sunscreen active ingredient or a combination of
nonprescription sunscreen active ingredients is generally
recognized as safe and effective.
The Committee expects FDA to produce guidance that
establishes the appropriate eligibility, data submission and
safety and effectiveness testing requirements that are
appropriate for such products that have been marketed to a
material extent for a material time with a history of safe and
effective use in a comparable jurisdiction. The Committee
expects that the stakeholder community will have adequate
opportunity to provide public comment during the creation of
guidance.
(b) Submissions pending issuance of final guidance
Irrespective of whether guidance has been issued under
subsection (a), FDA must review and act on pending requests in
accordance with this legislation, and, as of the date of
enactment, sponsors of new requests may submit such requests to
FDA, and FDA must review and act upon the requests as set forth
in this legislation.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
* * * * * * *
Subchapter I--Nonprescription Sunscreen Active Ingredients
SEC. 586. DEFINITIONS.
In this subchapter:
(1) The term ``Advisory Committee'' means the
Nonprescription Drug Advisory Committee or any
successor to such Committee.
(2) The terms ``generally recognized as safe and
effective'' and ``GRASE'' mean 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
product's labeling, as described in section 201(p).
(3) The term ``GRASE determination'' means, with
respect to a nonprescription sunscreen active
ingredient or a combination of nonprescription
sunscreen active ingredients, a determination of
whether such ingredients or combination of ingredients
is generally recognized as safe and effective and not
misbranded for use under the conditions prescribed,
recommended, or suggested in the product's labeling, as
described in section 201(p).
(4) The term ``nonprescription'' means not subject to
section 503(b)(1).
(5) The term ``pending request'' means each request
submitted to the Secretary--
(A) for consideration for inclusion in the
over-the-counter drug monograph system;
(B) that was deemed eligible for such review
by publication of a notice of eligibility in
the Federal Register prior to the date of
enactment of the Sunscreen Innovation Act; and
(C) for which safety and effectiveness data
has been submitted to the Secretary prior to
such date of enactment.
(6) The term ``sponsor'' means the person submitting
the request under section 586A(a), including a time and
extent application under section 586B, or the person
that submitted the pending request.
(7) 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 radiation.
(8) The term ``sunscreen'' means a product containing
one or more sunscreen active ingredients.
SEC. 586A. GENERAL PROVISIONS.
(a) 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 generally recognized as safe and
effective and not misbranded.
(b) Rules of Construction.--
(1) Currently marketed sunscreens.--Nothing in this
subchapter shall be construed to affect the marketing
of sunscreens that are lawfully marketed in the United
States on or before the date of enactment of this
subchapter.
(2) Ensuring safety and effectiveness.--Nothing in
this subchapter shall be construed to alter the
Secretary's authority to prohibit the marketing of a
sunscreen that is not safe and effective or to impose
restrictions on the marketing of a sunscreen to ensure
safety and effectiveness.
(3) Other products.--Nothing in this subchapter shall
be construed to affect the Secretary's regulation of
products other than sunscreens.
(c) Sunset.--This subchapter shall cease to be effective at
the end of the 5-year period beginning on the date of enactment
of this subchapter.
SEC. 586B. ELIGIBILITY DETERMINATION.
(a) In General.--Upon receipt of a request under section
586A(a), not later than 60 days after the date of receipt of
such request, the Secretary shall--
(1) determine whether the request is eligible for
further review under sections 586C and 586D, as
described in subsection (b);
(2) notify the sponsor of the Secretary's
determination; and
(3) make such determination publicly available in
accordance with subsection (c).
(b) Criteria for Eligibility.--
(1) In general.--To be eligible for review under
sections 586C and 586D, 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--
(A) is not included in the stayed sunscreen
monograph in part 352 of title 21, Code of
Federal Regulations; and
(B) has been used to a material extent and
for a material time, as described in section
201(p)(2).
(2) Time and extent application.--A sponsor shall
include in a request under section 586A(a) a time and
extent application including all the information
required to meet the standard described in paragraph
(1)(B).
(c) Public Availability.--
(1) Redactions for confidential information.--If a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is determined to be eligible for further
review under subsection (a)(1), 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.
(2) Identification of confidential information by
sponsor.--Sponsors shall identify any information which
the sponsor considers to be confidential information
described in paragraph (1).
(3) Confidentiality during eligibility review.--The
information contained in a request under section
586A(a) shall remain confidential during the
Secretary's consideration under this section of whether
the request is eligible for further review.
SEC. 586C. DATA SUBMISSION; FILING DETERMINATION.
(a) In General.--In the case of a request under section
586A(a) that is determined to be eligible under section 586B
for further review under this section and section 586D--
(1) the Secretary shall, in notifying the public
under section 586B(a)(3) of such eligibility
determination, invite the sponsor of the request and
any other interested party to submit, in support of or
otherwise relating to a GRASE determination--
(A) published and unpublished data and other
information related to the safety and
effectiveness of the nonprescription sunscreen
active ingredient or combination of
nonprescription sunscreen active ingredients
for its intended nonprescription uses; or
(B) any other comments; and
(2) not later than 60 days after the submission of
such data and other information by the sponsor,
including any revised submission of such data and other
information following a refusal to file under
subparagraph (B), the Secretary shall--
(A)(i) issue a written notification to the
sponsor determining that the request under
section 586A(a), together with such data and
other information, is sufficiently complete to
conduct a substantive review and make such
notification publicly available; and
(ii) file such request; or
(B) issue a written notification to the
sponsor refusing to file the request and
stating the reasons for the refusal and why the
data and other information submitted is not
sufficiently complete to conduct a substantive
review and make such notification publicly
available;
(3) the Secretary shall, in filing a request under
paragraph (2)--
(A) invite the public to submit further
comments with respect to such filing; and
(B) limit such public comment, and the
comment period under paragraph (1), to the
period ending on the date that is 60 days after
such filing;
(4) if the Secretary refuses to file the request--
(A) the sponsor may, within 30 days of
receipt of written notification of such
refusal, seek a meeting with the Secretary
regarding whether the Secretary should file the
request; and
(B) the Secretary shall convene the meeting;
and
(5) following any such meeting--
(A) if the sponsor asks that the Secretary
file the request (with or without amendments to
correct any purported deficiencies to the
request) the Secretary shall file the request
over protest, issue a written notification of
the filing to the sponsor, and make such
notification publicly available; and
(B) if the request is so filed over protest,
the Secretary shall not require the sponsor to
resubmit a copy of the request for purposes of
such filing.
(b) Reasons for Refusal to File Request.--The Secretary may
refuse to file a request submitted under section 586A(a) if the
Secretary determines the data or other information submitted by
the sponsor under this section are not sufficiently complete to
conduct a substantive review with respect to such request.
(c) Public Availability.--
(1) Redactions for confidential information.--The
Secretary shall make data and other information
submitted in connection with a request under section
586A(a) 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.
(2) Identification of confidential information by
sponsor.--Sponsors or any other individual submitting
data or other information under this section shall
identify any information which the sponsor or
individual considers to be confidential information
described in paragraph (1).
SEC. 586D. GRASE DETERMINATION.
(a) Review of New Request.--
(1) Proposed order by cder.--In the case of a request
under section 586A(a), the Director of the Center for
Drug Evaluation and Research shall--
(A) not later than 300 days after the date on
which the request is filed under section
586C(a), complete the review of the request and
issue a proposed order determining that--
(i) the nonprescription sunscreen
active ingredient or combination of
nonprescription sunscreen active
ingredients that is the subject of the
request--
(I) is GRASE; and
(II) is not misbranded;
(ii) the nonprescription sunscreen
active ingredient or combination of
nonprescription sunscreen active
ingredients that is the subject of the
request--
(I) is not GRASE; or
(II) is misbranded; or
(iii) additional information is
necessary to allow the Director of the
Center for Drug Evaluation and Research
to complete the review of such request;
(B) within such 300-day period, convene a
meeting of the Advisory Committee to review the
request under section 586A(a): and
(C) if the Director fails to issue such
proposed order within the 300-day period
referred to in subparagraph (A), transmit the
request to the Commissioner of Food and Drugs
for review.
(2) Proposed order by commissioner.--With respect to
a request transmitted to the Commissioner of Food and
Drugs under paragraph (1)(C), the Commissioner shall,
not later than 60 days after the date of such
transmission, issue--
(A) a proposed order described in paragraph
(1)(A)(i);
(B) a proposed order described in paragraph
(1)(A)(ii); or
(C) a proposed order described in paragraph
(1)(A)(iii).
(3) Publication in federal register; public comment
period.--A proposed order issued under paragraph (1) or
(2) with respect to a request shall--
(A) be published in the Federal Register; and
(B) solicit public comments for a period of
not more than 45 days.
(4) Final order by cder.--In the case of a proposed
order under paragraph (1)(A) or (2) with respect to a
request, the Director of the Center for Drug Evaluation
and Research shall--
(A) issue a final order with respect to the
request--
(i) in the case of a proposed order
under clause (i) or (ii) of paragraph
(1)(A) or subparagraph (A) or (B) of
paragraph (2), not later than 90 days
after the end of the public comment
period under paragraph (3)(B); or
(ii) in the case of a proposed order
under paragraph (1)(A)(iii) or
paragraph (2)(C), not later than 210
days after the date on which the
sponsor submits the additional
information requested pursuant to such
proposed order; or
(B) if the Director fails to issue such final
order within such 90- or 210-day period, as
applicable, transmit such proposed order to the
Commissioner of Food and Drugs for review.
(5) Final order by commissioner.--With respect to a
proposed order transmitted to the Commissioner of Food
and Drugs under paragraph (4)(B), the Commissioner
shall issue a final order with respect to such proposed
order not later than 60 days after the date of such
transmission.
(b) Review of Pending Requests.--
(1) In general.--The review of a pending request
shall be carried out by the Director of the Center for
Drug Evaluation and Research in accordance with
paragraph (3).
(2) Inapplicability of certain provisions.--Sections
586B and 586C shall not apply with respect to any
pending request.
(3) Proposed order by cder.--The Director of the
Center for Drug Evaluation and Research shall--
(A) within the timeframe applicable under
paragraph (4), complete the review of the
request and issue a proposed order determining
that--
(i) the nonprescription sunscreen
active ingredient or combination of
nonprescription sunscreen active
ingredients that is the subject of the
pending request--
(I) is GRASE; and
(II) is not misbranded;
(ii) the nonprescription sunscreen
active ingredient or combination of
nonprescription sunscreen active
ingredients that is the subject of the
pending request--
(I) is not GRASE; or
(II) is misbranded; or
(iii) additional information is
necessary to allow the Director of the
Center for Drug Evaluation and Research
to complete the review of the pending
request; and
(B) if the Director fails to issue such
proposed order within the timeframe applicable
under paragraph (4), transmit the pending
request to the Commissioner of Food and Drugs
for review.
(4) Timeframe for issuance of proposed order by
cder.--The Director of the Center for Drug Evaluation
and Research shall issue a proposed order, as required
by paragraph (3)(A)--
(A) in the case of a pending request for
which the Food and Drug Administration has
issued a feedback letter before the date of
enactment of the Sunscreen Innovation Act, not
later than 45 days after such date of
enactment; and
(B) in the case of a pending request for
which the Food and Drug Administration has not
issued a feedback letter before the date of
enactment of the Sunscreen Innovation Act, not
later than 90 days after such date of
enactment.
(5) Proposed order by commissioner.--With respect to
a pending request transmitted to the Commissioner of
Food and Drugs under paragraph (3)(B), the Commissioner
shall, not later than 60 days after the date of such
transmission, issue--
(A) a proposed order described in paragraph
(3)(A)(i);
(B) a proposed order described in paragraph
(3)(A)(ii); or
(C) a proposed order described in paragraph
(3)(A)(iii).
(6) Publication in federal register; public comment
period.--A proposed order issued under paragraph (3) or
(5) with respect to a pending request shall--
(A) be published in the Federal Register; and
(B) solicit public comments for a period of
not more than 45 days.
(7) Advisory committee.--For a proposed order issued
under paragraph (3)(A)(iii) or (5)(C) requesting
additional information, an Advisory Committee meeting
shall be convened if the sponsor requests, or the
Director of the Center for Drug Evaluation and Research
or the Commissioner of Food and Drugs decides, to
convene such a meeting for the purpose of reviewing the
pending request.
(8) Final order by cder.--In the case of a proposed
order under paragraph (3)(A) or (5) with respect to a
request, the Director of the Center for Drug Evaluation
and Research shall--
(A) issue a final order with respect to the
request--
(i) in the case of a proposed order
under clause (i) or (ii) of paragraph
(3)(A) or subparagraph (A) or (B) of
paragraph (5), not later than 90 days
after the end of the public comment
period under paragraph (3)(B); or
(ii) in the case of a proposed order
under paragraph (3)(A)(iii) or
paragraph (5)(C)--
(I) if the Advisory Committee
is not convened pursuant to
paragraph (7), not later than
210 days after the date on
which the sponsor submits the
additional information
requested pursuant to such
proposed order; or
(II) if the Advisory
Committee is convened pursuant
to paragraph (7), not later
than 270 days after date on
which the sponsor submits such
additional information; or
(B) if the Director fails to issue such final
order within such 90-, 210-, and 270-day
period, as applicable, transmit such proposed
order to the Commissioner of Food and Drugs for
review.
(9) Final order by commissioner.--With respect to a
proposed order transmitted to the Commissioner of Food
and Drugs under paragraph (8)(B), the Commissioner
shall issue a final order with respect to such proposed
order not later than 60 days after the date of such
transmission.
(c) Advisory Committee.--
(1) Limitations.--The Food and Drug Administration--
(A) shall not be required to convene the
Advisory Committee--
(i) more than once with respect to
any request under section 586A(a) or
any pending request; or
(ii) more than twice in any twelve
month period with respect to the review
of submissions under this section; and
(B) shall not be required to submit more than
3 submissions to the Advisory Committee per
meeting.
(2) Membership.--In appointing the members of the
Advisory Committee, the Secretary may select to serve
temporarily as voting members on the Advisory
Committee--
(A) members of other Federal advisory
committees; or
(B) consultants from outside of the
Department of Health and Human Services who
have substantive expertise regarding sunscreen
active ingredients.
(d) No Delegation.--Any responsibility vested by this section
in the Commissioner of Food and Drugs is not delegable.
(e) Effect of Final Order.--
(1) Content.--A final order under subsection (a)(4),
(a)(5), (b)(8), or (b)(9) with respect to a request
under section 586A(a) or a pending request shall
determine that the nonprescription sunscreen active
ingredient or combination of nonprescription sunscreen
active ingredients that is the subject of the request--
(A) is GRASE and is not misbranded; or
(B) is not GRASE or is misbranded.
(2) Active ingredients determined to be grase.--Upon
issuance of a final order determining that a
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is GRASE and is not misbranded, the active
ingredient or combination of active ingredients shall
be permitted to be introduced or delivered into
interstate commerce, for use under the conditions
subject to the final order, in accordance with all
requirements applicable to drugs not subject to section
503(b)(1).
(3) Active ingredients determined not to be grase.--
Upon issuance of a final order determining that the
nonprescription sunscreen active ingredient or
combination of nonprescription sunscreen active
ingredients is not GRASE or is misbranded, the active
ingredient or combination of active ingredients shall
not be introduced or delivered into interstate
commerce, for use under the conditions subject to the
final order, unless an application submitted pursuant
to section 505(b) with respect to such active
ingredient or combination of active ingredients is
approved.
SEC. 586E. REPORTS.
(a) GAO Report.--Not later than 1 year after the date of
enactment of the Sunscreen Innovation Act, the Comptroller
General of the United States shall--
(1) submit a report reviewing the overall progress of
the Secretary in carrying out this subchapter to the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives; and
(2) include findings on--
(A) the progress made in completing the
review of pending requests; and
(B) the role of the Office of the
Commissioner of Food and Drugs in issuing
determinations with respect to pending
requests, including the number of requests
transferred to the Office of the Commissioner
under section 586D.
(b) Secretary's Report.--
(1) In general.--Not later than 1 year after the date
of enactment of the Sunscreen Innovation Act, and every
2 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 section. Each report under
this subsection shall be posted on the Internet site of
the Food and Drug Administration.
(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 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, 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
in a timely manner GRASE determinations for
requests submitted under section 586A(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 or combination of
nonprescription sunscreen active
ingredients is GRASE and 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, 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) a description of the staffing and
resources relating to the costs associated with
the review and decisionmaking pertaining to
requests under this subchapter;
(D) a review of the progress made in meeting
the deadlines with respect to processing
requests under this subchapter;
(E) to the extent the Secretary determines
appropriate, recommendations for process
improvements in the handling of pending and new
requests, including the advisory committee
review process; and
(F) recommendations for expanding the
applicability of this subchapter to
nonprescription active ingredients that are not
related to the sunscreen category of over-the-
counter drugs.
(c) Method.--The Secretary shall publish the reports required
under subsection (b) 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.
* * * * * * *