[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4250 Received in Senate (RDS)]
113th CONGRESS
2d Session
H. R. 4250
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 29, 2014
Received
_______________________________________________________________________
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to provide an
alternative process for review of safety and effectiveness of
nonprescription sunscreen active ingredients and for other purposes.
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.
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.
Passed the House of Representatives July 28, 2014.
Attest:
KAREN L. HAAS,
Clerk.