[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4250 Reported in House (RH)]

                                                 Union Calendar No. 418
113th CONGRESS
  2d Session
                                H. R. 4250

                          [Report No. 113-558]

    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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 13, 2014

 Mr. Whitfield (for himself and Mr. Dingell) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

                             July 24, 2014

 Additional sponsors: Mr. Farr, Mr. Guthrie, Mr. Tiberi, Mr. Stivers, 
 Mr. Rogers of Kentucky, Mr. Barr, Mr. Forbes, Mr. Carney, Mr. Lance, 
Mrs. Ellmers, Mrs. Blackburn, Mrs. Carolyn B. Maloney of New York, Mr. 
Griffin of Arkansas, Mr. Crenshaw, Mr. Lankford, Mr. Dent, Mr. Rooney, 
 Mr. Barrow of Georgia, Mr. Kingston, Mrs. Noem, Mr. Latta, Mr. Graves 
   of Georgia, Mr. Ross, Mr. Bishop of New York, Mr. Perlmutter, Mr. 
   Murphy of Pennsylvania, Mr. Diaz-Balart, Mr. Johnson of Ohio, Mr. 
   Matheson, Mr. Roskam, Mr. Fleischmann, Mr. Chabot, and Mr. Renacci

                             July 24, 2014

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on March 
                               13, 2014]


_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to provide an 
     alternative process for review of safety and effectiveness of 
  nonprescription sunscreen active ingredients and for other purposes.


 


    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Sunscreen Innovation Act''.

SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE INGREDIENTS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by adding at the end the following:

      ``Subchapter I--Nonprescription Sunscreen Active Ingredients

``SEC. 586. DEFINITIONS.

    ``In this subchapter:
            ``(1) The term `Advisory Committee' means the 
        Nonprescription Drug Advisory Committee or any successor to 
        such Committee.
            ``(2) The terms `generally recognized as safe and 
        effective' and `GRASE' mean generally recognized, among experts 
        qualified by scientific training and experience to evaluate the 
        safety and effectiveness of drugs, as safe and effective for 
        use under the conditions prescribed, recommended, or suggested 
        in the product's labeling, as described in section 201(p).
            ``(3) The term `GRASE determination' means, with respect to 
        a nonprescription sunscreen active ingredient or a combination 
        of nonprescription sunscreen active ingredients, a 
        determination of whether such ingredients or combination of 
        ingredients is generally recognized as safe and effective and 
        not misbranded for use under the conditions prescribed, 
        recommended, or suggested in the product's labeling, as 
        described in section 201(p).
            ``(4) The term `nonprescription' means not subject to 
        section 503(b)(1).
            ``(5) The term `pending request' means each request 
        submitted to the Secretary--
                    ``(A) for consideration for inclusion in the over-
                the-counter drug monograph system;
                    ``(B) that was deemed eligible for such review by 
                publication of a notice of eligibility in the Federal 
                Register prior to the date of enactment of the 
                Sunscreen Innovation Act; and
                    ``(C) for which safety and effectiveness data has 
                been submitted to the Secretary prior to such date of 
                enactment.
            ``(6) The term `sponsor' means the person submitting the 
        request under section 586A(a), including a time and extent 
        application under section 586B, or the person that submitted 
        the pending request.
            ``(7) The term `sunscreen active ingredient' means an 
        active ingredient that is intended for application to the skin 
        of humans for purposes of absorbing, reflecting, or scattering 
        radiation.
            ``(8) The term `sunscreen' means a product containing one 
        or more sunscreen active ingredients.

``SEC. 586A. GENERAL PROVISIONS.

    ``(a) Requests.--Any person may submit a request to the Secretary 
for a determination of whether a nonprescription sunscreen active 
ingredient or a combination of nonprescription sunscreen active 
ingredients, for use under specified conditions, to be prescribed, 
recommended, or suggested in the labeling thereof (including dosage 
form, dosage strength, and route of administration) is generally 
recognized as safe and effective and not misbranded.
    ``(b) Rules of Construction.--
            ``(1) Currently marketed sunscreens.--Nothing in this 
        subchapter shall be construed to affect the marketing of 
        sunscreens that are lawfully marketed in the United States on 
        or before the date of enactment of this subchapter.
            ``(2) Ensuring safety and effectiveness.--Nothing in this 
        subchapter shall be construed to alter the Secretary's 
        authority to prohibit the marketing of a sunscreen that is not 
        safe and effective or to impose restrictions on the marketing 
        of a sunscreen to ensure safety and effectiveness.
            ``(3) Other products.--Nothing in this subchapter shall be 
        construed to affect the Secretary's regulation of products 
        other than sunscreens.
    ``(c) Sunset.--This subchapter shall cease to be effective at the 
end of the 5-year period beginning on the date of enactment of this 
subchapter.

``SEC. 586B. ELIGIBILITY DETERMINATION.

    ``(a) In General.--Upon receipt of a request under section 586A(a), 
not later than 60 days after the date of receipt of such request, the 
Secretary shall--
            ``(1) determine whether the request is eligible for further 
        review under sections 586C and 586D, as described in subsection 
        (b);
            ``(2) notify the sponsor of the Secretary's determination; 
        and
            ``(3) make such determination publicly available in 
        accordance with subsection (c).
    ``(b) Criteria for Eligibility.--
            ``(1) In general.--To be eligible for review under sections 
        586C and 586D, a request shall be for a nonprescription 
        sunscreen active ingredient or combination of nonprescription 
        sunscreen active ingredients, for use under specified 
        conditions, to be prescribed, recommended, or suggested in the 
        labeling thereof, that--
                    ``(A) is not included in the stayed sunscreen 
                monograph in part 352 of title 21, Code of Federal 
                Regulations; and
                    ``(B) has been used to a material extent and for a 
                material time, as described in section 201(p)(2).
            ``(2) Time and extent application.--A sponsor shall include 
        in a request under section 586A(a) a time and extent 
        application including all the information required to meet the 
        standard described in paragraph (1)(B).
    ``(c) Public Availability.--
            ``(1) Redactions for confidential information.--If a 
        nonprescription sunscreen active ingredient or combination of 
        nonprescription sunscreen active ingredients is determined to 
        be eligible for further review under subsection (a)(1), the 
        Secretary shall make the request publicly available, with 
        redactions for information that is treated as confidential 
        under section 552(b) of title 5, United States Code, section 
        1905 of title 18, United States Code, or section 301(j) of this 
        Act.
            ``(2) Identification of confidential information by 
        sponsor.--Sponsors shall identify any information which the 
        sponsor considers to be confidential information described in 
        paragraph (1).
            ``(3) Confidentiality during eligibility review.--The 
        information contained in a request under section 586A(a) shall 
        remain confidential during the Secretary's consideration under 
        this section of whether the request is eligible for further 
        review.

``SEC. 586C. DATA SUBMISSION; FILING DETERMINATION.

    ``(a) In General.--In the case of a request under section 586A(a) 
that is determined to be eligible under section 586B for further review 
under this section and section 586D--
            ``(1) the Secretary shall, in notifying the public under 
        section 586B(a)(3) of such eligibility determination, invite 
        the sponsor of the request and any other interested party to 
        submit, in support of or otherwise relating to a GRASE 
        determination--
                    ``(A) published and unpublished data and other 
                information related to the safety and effectiveness of 
                the nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients for its intended nonprescription uses; or
                    ``(B) any other comments; and
            ``(2) not later than 60 days after the submission of such 
        data and other information by the sponsor, including any 
        revised submission of such data and other information following 
        a refusal to file under subparagraph (B), the Secretary shall--
                    ``(A)(i) issue a written notification to the 
                sponsor determining that the request under section 
                586A(a), together with such data and other information, 
                is sufficiently complete to conduct a substantive 
                review and make such notification publicly available; 
                and
                    ``(ii) file such request; or
                    ``(B) issue a written notification to the sponsor 
                refusing to file the request and stating the reasons 
                for the refusal and why the data and other information 
                submitted is not sufficiently complete to conduct a 
                substantive review and make such notification publicly 
                available;
            ``(3) the Secretary shall, in filing a request under 
        paragraph (2)--
                    ``(A) invite the public to submit further comments 
                with respect to such filing; and
                    ``(B) limit such public comment, and the comment 
                period under paragraph (1), to the period ending on the 
                date that is 60 days after such filing;
            ``(4) if the Secretary refuses to file the request--
                    ``(A) the sponsor may, within 30 days of receipt of 
                written notification of such refusal, seek a meeting 
                with the Secretary regarding whether the Secretary 
                should file the request; and
                    ``(B) the Secretary shall convene the meeting; and
            ``(5) following any such meeting--
                    ``(A) if the sponsor asks that the Secretary file 
                the request (with or without amendments to correct any 
                purported deficiencies to the request) the Secretary 
                shall file the request over protest, issue a written 
                notification of the filing to the sponsor, and make 
                such notification publicly available; and
                    ``(B) if the request is so filed over protest, the 
                Secretary shall not require the sponsor to resubmit a 
                copy of the request for purposes of such filing.
    ``(b) Reasons for Refusal to File Request.--The Secretary may 
refuse to file a request submitted under section 586A(a) if the 
Secretary determines the data or other information submitted by the 
sponsor under this section are not sufficiently complete to conduct a 
substantive review with respect to such request.
    ``(c) Public Availability.--
            ``(1) Redactions for confidential information.--The 
        Secretary shall make data and other information submitted in 
        connection with a request under section 586A(a) publicly 
        available, with redactions for information that is treated as 
        confidential under section 552(b) of title 5, United States 
        Code, section 1905 of title 18, United States Code, or section 
        301(j) of this Act.
            ``(2) Identification of confidential information by 
        sponsor.--Sponsors or any other individual submitting data or 
        other information under this section shall identify any 
        information which the sponsor or individual considers to be 
        confidential information described in paragraph (1).

``SEC. 586D. GRASE DETERMINATION.

    ``(a) Review of New Request.--
            ``(1) Proposed order by cder.--In the case of a request 
        under section 586A(a), the Director of the Center for Drug 
        Evaluation and Research shall--
                    ``(A) not later than 300 days after the date on 
                which the request is filed under section 586C(a), 
                complete the review of the request and issue a proposed 
                order determining that--
                            ``(i) the nonprescription sunscreen active 
                        ingredient or combination of nonprescription 
                        sunscreen active ingredients that is the 
                        subject of the request--
                                    ``(I) is GRASE; and
                                    ``(II) is not misbranded;
                            ``(ii) the nonprescription sunscreen active 
                        ingredient or combination of nonprescription 
                        sunscreen active ingredients that is the 
                        subject of the request--
                                    ``(I) is not GRASE; or
                                    ``(II) is misbranded; or
                            ``(iii) additional information is necessary 
                        to allow the Director of the Center for Drug 
                        Evaluation and Research to complete the review 
                        of such request;
                    ``(B) within such 300-day period, convene a meeting 
                of the Advisory Committee to review the request under 
                section 586A(a): and
                    ``(C) if the Director fails to issue such proposed 
                order within the 300-day period referred to in 
                subparagraph (A), transmit the request to the 
                Commissioner of Food and Drugs for review.
            ``(2) Proposed order by commissioner.--With respect to a 
        request transmitted to the Commissioner of Food and Drugs under 
        paragraph (1)(C), the Commissioner shall, not later than 60 
        days after the date of such transmission, issue--
                    ``(A) a proposed order described in paragraph 
                (1)(A)(i);
                    ``(B) a proposed order described in paragraph 
                (1)(A)(ii); or
                    ``(C) a proposed order described in paragraph 
                (1)(A)(iii).
            ``(3) Publication in federal register; public comment 
        period.--A proposed order issued under paragraph (1) or (2) 
        with respect to a request shall--
                    ``(A) be published in the Federal Register; and
                    ``(B) solicit public comments for a period of not 
                more than 45 days.
            ``(4) Final order by cder.--In the case of a proposed order 
        under paragraph (1)(A) or (2) with respect to a request, the 
        Director of the Center for Drug Evaluation and Research shall--
                    ``(A) issue a final order with respect to the 
                request--
                            ``(i) in the case of a proposed order under 
                        clause (i) or (ii) of paragraph (1)(A) or 
                        subparagraph (A) or (B) of paragraph (2), not 
                        later than 90 days after the end of the public 
                        comment period under paragraph (3)(B); or
                            ``(ii) in the case of a proposed order 
                        under paragraph (1)(A)(iii) or paragraph 
                        (2)(C), not later than 210 days after the date 
                        on which the sponsor submits the additional 
                        information requested pursuant to such proposed 
                        order; or
                    ``(B) if the Director fails to issue such final 
                order within such 90- or 210-day period, as applicable, 
                transmit such proposed order to the Commissioner of 
                Food and Drugs for review.
            ``(5) Final order by commissioner.--With respect to a 
        proposed order transmitted to the Commissioner of Food and 
        Drugs under paragraph (4)(B), the Commissioner shall issue a 
        final order with respect to such proposed order not later than 
        60 days after the date of such transmission.
    ``(b) Review of Pending Requests.--
            ``(1) In general.--The review of a pending request shall be 
        carried out by the Director of the Center for Drug Evaluation 
        and Research in accordance with paragraph (3).
            ``(2) Inapplicability of certain provisions.--Sections 586B 
        and 586C shall not apply with respect to any pending request.
            ``(3) Proposed order by cder.--The Director of the Center 
        for Drug Evaluation and Research shall--
                    ``(A) within the timeframe applicable under 
                paragraph (4), complete the review of the request and 
                issue a proposed order determining that--
                            ``(i) the nonprescription sunscreen active 
                        ingredient or combination of nonprescription 
                        sunscreen active ingredients that is the 
                        subject of the pending request--
                                    ``(I) is GRASE; and
                                    ``(II) is not misbranded;
                            ``(ii) the nonprescription sunscreen active 
                        ingredient or combination of nonprescription 
                        sunscreen active ingredients that is the 
                        subject of the pending request--
                                    ``(I) is not GRASE; or
                                    ``(II) is misbranded; or
                            ``(iii) additional information is necessary 
                        to allow the Director of the Center for Drug 
                        Evaluation and Research to complete the review 
                        of the pending request; and
                    ``(B) if the Director fails to issue such proposed 
                order within the timeframe applicable under paragraph 
                (4), transmit the pending request to the Commissioner 
                of Food and Drugs for review.
            ``(4) Timeframe for issuance of proposed order by cder.--
        The Director of the Center for Drug Evaluation and Research 
        shall issue a proposed order, as required by paragraph (3)(A)--
                    ``(A) in the case of a pending request for which 
                the Food and Drug Administration has issued a feedback 
                letter before the date of enactment of the Sunscreen 
                Innovation Act, not later than 45 days after such date 
                of enactment; and
                    ``(B) in the case of a pending request for which 
                the Food and Drug Administration has not issued a 
                feedback letter before the date of enactment of the 
                Sunscreen Innovation Act, not later than 90 days after 
                such date of enactment.
            ``(5) Proposed order by commissioner.--With respect to a 
        pending request transmitted to the Commissioner of Food and 
        Drugs under paragraph (3)(B), the Commissioner shall, not later 
        than 60 days after the date of such transmission, issue--
                    ``(A) a proposed order described in paragraph 
                (3)(A)(i);
                    ``(B) a proposed order described in paragraph 
                (3)(A)(ii); or
                    ``(C) a proposed order described in paragraph 
                (3)(A)(iii).
            ``(6) Publication in federal register; public comment 
        period.--A proposed order issued under paragraph (3) or (5) 
        with respect to a pending request shall--
                    ``(A) be published in the Federal Register; and
                    ``(B) solicit public comments for a period of not 
                more than 45 days.
            ``(7) Advisory committee.--For a proposed order issued 
        under paragraph (3)(A)(iii) or (5)(C) requesting additional 
        information, an Advisory Committee meeting shall be convened if 
        the sponsor requests, or the Director of the Center for Drug 
        Evaluation and Research or the Commissioner of Food and Drugs 
        decides, to convene such a meeting for the purpose of reviewing 
        the pending request.
            ``(8) Final order by cder.--In the case of a proposed order 
        under paragraph (3)(A) or (5) with respect to a request, the 
        Director of the Center for Drug Evaluation and Research shall--
                    ``(A) issue a final order with respect to the 
                request--
                            ``(i) in the case of a proposed order under 
                        clause (i) or (ii) of paragraph (3)(A) or 
                        subparagraph (A) or (B) of paragraph (5), not 
                        later than 90 days after the end of the public 
                        comment period under paragraph (3)(B); or
                            ``(ii) in the case of a proposed order 
                        under paragraph (3)(A)(iii) or paragraph 
                        (5)(C)--
                                    ``(I) if the Advisory Committee is 
                                not convened pursuant to paragraph (7), 
                                not later than 210 days after the date 
                                on which the sponsor submits the 
                                additional information requested 
                                pursuant to such proposed order; or
                                    ``(II) if the Advisory Committee is 
                                convened pursuant to paragraph (7), not 
                                later than 270 days after date on which 
                                the sponsor submits such additional 
                                information; or
                    ``(B) if the Director fails to issue such final 
                order within such 90-, 210-, and 270-day period, as 
                applicable, transmit such proposed order to the 
                Commissioner of Food and Drugs for review.
            ``(9) Final order by commissioner.--With respect to a 
        proposed order transmitted to the Commissioner of Food and 
        Drugs under paragraph (8)(B), the Commissioner shall issue a 
        final order with respect to such proposed order not later than 
        60 days after the date of such transmission.
    ``(c) Advisory Committee.--
            ``(1) Limitations.--The Food and Drug Administration--
                    ``(A) shall not be required to convene the Advisory 
                Committee--
                            ``(i) more than once with respect to any 
                        request under section 586A(a) or any pending 
                        request; or
                            ``(ii) more than twice in any twelve month 
                        period with respect to the review of 
                        submissions under this section; and
                    ``(B) shall not be required to submit more than 3 
                submissions to the Advisory Committee per meeting.
            ``(2) Membership.--In appointing the members of the 
        Advisory Committee, the Secretary may select to serve 
        temporarily as voting members on the Advisory Committee--
                    ``(A) members of other Federal advisory committees; 
                or
                    ``(B) consultants from outside of the Department of 
                Health and Human Services who have substantive 
                expertise regarding sunscreen active ingredients.
    ``(d) No Delegation.--Any responsibility vested by this section in 
the Commissioner of Food and Drugs is not delegable.
    ``(e) Effect of Final Order.--
            ``(1) Content.--A final order under subsection (a)(4), 
        (a)(5), (b)(8), or (b)(9) with respect to a request under 
        section 586A(a) or a pending request shall determine that the 
        nonprescription sunscreen active ingredient or combination of 
        nonprescription sunscreen active ingredients that is the 
        subject of the request--
                    ``(A) is GRASE and is not misbranded; or
                    ``(B) is not GRASE or is misbranded.
            ``(2) Active ingredients determined to be grase.--Upon 
        issuance of a final order determining that a nonprescription 
        sunscreen active ingredient or combination of nonprescription 
        sunscreen active ingredients is GRASE and is not misbranded, 
        the active ingredient or combination of active ingredients 
        shall be permitted to be introduced or delivered into 
        interstate commerce, for use under the conditions subject to 
        the final order, in accordance with all requirements applicable 
        to drugs not subject to section 503(b)(1).
            ``(3) Active ingredients determined not to be grase.--Upon 
        issuance of a final order determining that the nonprescription 
        sunscreen active ingredient or combination of nonprescription 
        sunscreen active ingredients is not GRASE or is misbranded, the 
        active ingredient or combination of active ingredients shall 
        not be introduced or delivered into interstate commerce, for 
        use under the conditions subject to the final order, unless an 
        application submitted pursuant to section 505(b) with respect 
        to such active ingredient or combination of active ingredients 
        is approved.

``SEC. 586E. REPORTS.

    ``(a) GAO Report.--Not later than 1 year after the date of 
enactment of the Sunscreen Innovation Act, the Comptroller General of 
the United States shall--
            ``(1) submit a report reviewing the overall progress of the 
        Secretary in carrying out this subchapter to the Committee on 
        Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives; and
            ``(2) include findings on--
                    ``(A) the progress made in completing the review of 
                pending requests; and
                    ``(B) the role of the Office of the Commissioner of 
                Food and Drugs in issuing determinations with respect 
                to pending requests, including the number of requests 
                transferred to the Office of the Commissioner under 
                section 586D.
    ``(b) Secretary's Report.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Sunscreen Innovation Act, and every 2 years 
        thereafter, the Secretary shall issue a report to the Committee 
        on Health, Education, Labor, and Pensions of the Senate and the 
        Committee on Energy and Commerce of the House of 
        Representatives describing actions taken under this section. 
        Each report under this subsection shall be posted on the 
        Internet site of the Food and Drug Administration.
            ``(2) Contents.--The reports under this subsection shall 
        include--
                    ``(A) a review of the progress made in issuing 
                GRASE determinations for pending requests, including 
                the number of pending requests--
                            ``(i) reviewed and the decision times for 
                        each request, measured from the date of the 
                        original request for an eligibility 
                        determination submitted by the sponsor;
                            ``(ii) resulting in a determination that 
                        the nonprescription sunscreen active ingredient 
                        or combination of nonprescription sunscreen 
                        active ingredients is GRASE and not misbranded;
                            ``(iii) resulting in a determination that 
                        the nonprescription sunscreen active ingredient 
                        or combination of nonprescription sunscreen 
                        active ingredients is not GRASE and is 
                        misbranded and the reasons for such 
                        determinations; and
                            ``(iv) for which a determination has not 
                        been made, an explanation for the delay, a 
                        description of the current status of each such 
                        request, and the length of time each such 
                        request has been pending, measured from the 
                        date of original request for an eligibility 
                        determination by the sponsor;
                    ``(B) a review of the progress made in issuing in a 
                timely manner GRASE determinations for requests 
                submitted under section 586A(a), including the number 
                of such requests--
                            ``(i) reviewed and the decision times for 
                        each request;
                            ``(ii) resulting in a determination that 
                        the nonprescription sunscreen active ingredient 
                        or combination of nonprescription sunscreen 
                        active ingredients is GRASE and not misbranded;
                            ``(iii) resulting in a determination that 
                        the nonprescription sunscreen active ingredient 
                        or combination of nonprescription sunscreen 
                        active ingredients is not GRASE and is 
                        misbranded and the reasons for such 
                        determinations; and
                            ``(iv) for which a determination has not 
                        been made, an explanation for the delay, a 
                        description of the current status of each such 
                        request, and the length of time each such 
                        request has been pending, measured from the 
                        date of original request for an eligibility 
                        determination by the sponsor;
                    ``(C) a description of the staffing and resources 
                relating to the costs associated with the review and 
                decisionmaking pertaining to requests under this 
                subchapter;
                    ``(D) a review of the progress made in meeting the 
                deadlines with respect to processing requests under 
                this subchapter;
                    ``(E) to the extent the Secretary determines 
                appropriate, recommendations for process improvements 
                in the handling of pending and new requests, including 
                the advisory committee review process; and
                    ``(F) recommendations for expanding the 
                applicability of this subchapter to nonprescription 
                active ingredients that are not related to the 
                sunscreen category of over-the-counter drugs.
    ``(c) Method.--The Secretary shall publish the reports required 
under subsection (b) in the manner the Secretary determines to be the 
most effective for efficiently disseminating the report, including 
publication of the report on the Internet website of the Food and Drug 
Administration.''.

SEC. 3. GUIDANCE.

    (a) In General.--
            (1) Issuance.--Not later than one year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs, 
        shall issue guidance, in accordance with good guidance 
        practices, on the implementation of, and compliance with, 
        subchapter I of chapter V of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 2, including guidance on--
                    (A) the criteria for determining whether a 
                nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients has been used to a material extent and for 
                a material time, as described in section 201(p)(2) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                321(p)(2));
                    (B) the format and content of a safety and 
                effectiveness data submission; and
                    (C) the safety and efficacy standards for 
                determining whether a nonprescription sunscreen active 
                ingredients or combination of nonprescription sunscreen 
                active ingredients is generally recognized as safe and 
                effective, as defined in section 586 of such subchapter 
                I.
            (2) Inapplicability of paperwork reduction act.--Chapter 35 
        of title 44, United States Code, shall not apply to collections 
        of information made for purposes of guidance under this 
        subsection.
    (b) Submissions Pending Issuance of Final Guidance.--Irrespective 
of whether final guidance under subsection (a) has been issued--
            (1) persons may, beginning on the date of enactment of this 
        Act, make submissions under subchapter I of chapter V of the 
        Federal Food, Drug, and Cosmetic Act, as added by section 2; 
        and
            (2) the Secretary of Health and Human Services, acting 
        through the Commissioner of Food and Drugs, shall review and 
        act upon such submissions in accordance with such subchapter.
                                                 Union Calendar No. 418

113th CONGRESS

  2d Session

                               H. R. 4250

                          [Report No. 113-558]

_______________________________________________________________________

                                 A BILL

    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.

_______________________________________________________________________

                             July 24, 2014

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed