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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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.

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