```

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2141 Enrolled Bill (ENR)]

        S.2141

                     One Hundred Thirteenth Congress

                                 of the

                        United States of America

                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Friday,
           the third day of January, two thousand and fourteen

                                 An Act

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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
    This Act may be cited as the ``Sunscreen Innovation Act''.
SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE INGREDIENTS.
    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

 ``Subchapter I--Nonprescription Sunscreen and Other Active Ingredients

    ``SEC. 586. DEFINITIONS.
    ``In this subchapter--
        ``(1) the term `Advisory Committee' means the Nonprescription 
    Drug Advisory Committee of the Food and Drug Administration or any 
    successor to such Committee;
        ``(2) the term `final sunscreen order' means an order published 
    by the Secretary in the Federal Register containing information 
    stating that a nonprescription sunscreen active ingredient or 
    combination of nonprescription sunscreen active ingredients--
            ``(A) is GRASE and is not misbranded if marketed in 
        accordance with such order; or
            ``(B) is not GRASE and is misbranded;
        ``(3) the term `GRASE' means generally recognized, among 
    experts qualified by scientific training and experience to evaluate 
    the safety and effectiveness of drugs, as safe and effective for 
    use under the conditions prescribed, recommended, or suggested in 
    the labeling of a drug as described in section 201(p);
        ``(4) the term `GRASE determination' means, with respect to a 
    nonprescription active ingredient or a combination of 
    nonprescription active ingredients, a determination of whether such 
    ingredient or combination of ingredients is GRASE;
        ``(5) the term `nonprescription' means not subject to section 
    503(b)(1);
        ``(6) the term `pending request' means each request with 
    respect to a nonprescription sunscreen active ingredient submitted 
    under section 330.14 of title 21, Code of Federal Regulations (as 
    in effect on the date of enactment of the Sunscreen Innovation Act) 
    for consideration for inclusion in the over-the-counter drug 
    monograph system--
            ``(A) that was determined to be eligible for such review by 
        publication of a notice of eligibility in the Federal Register 
        prior to the date of enactment of such Act; and
            ``(B) for which safety and effectiveness data have been 
        submitted to the Secretary prior to such date of enactment;
        ``(7) the term `proposed sunscreen order' means an order 
    containing a tentative determination published by the Secretary in 
    the Federal Register containing information proposing that a 
    nonprescription sunscreen active ingredient or combination of 
    nonprescription sunscreen active ingredients--
            ``(A) is GRASE and is not misbranded if marketed in 
        accordance with such order;
            ``(B) is not GRASE and is misbranded; or
            ``(C) is not GRASE and is misbranded because the data are 
        insufficient to classify such ingredient or combination of 
        ingredients as GRASE and not misbranded and additional 
        information is necessary to allow the Secretary to determine 
        otherwise;
        ``(8) the term `sponsor' means the person that submitted--
            ``(A) a request under section 586A;
            ``(B) a pending request; or
            ``(C) any other application subject to this subchapter;
        ``(9) the term `sunscreen' means a drug containing one or more 
    sunscreen active ingredients; and
        ``(10) the term `sunscreen active ingredient' means an active 
    ingredient that is intended for application to the skin of humans 
    for purposes of absorbing, reflecting, or scattering ultraviolet 
    radiation.
``SEC. 586A. SUBMISSION OF REQUESTS.
    ``Any person may submit a request to the Secretary for a 
determination of whether a nonprescription sunscreen active ingredient 
or a combination of nonprescription sunscreen active ingredients, for 
use under specified conditions, to be prescribed, recommended, or 
suggested in the labeling thereof (including dosage form, dosage 
strength, and route of administration) is GRASE and should be included 
in part 352 of title 21, Code of Federal Regulations (or any successor 
regulations) concerning nonprescription sunscreen.
``SEC. 586B. ELIGIBILITY DETERMINATIONS; DATA SUBMISSION; FILING.
    ``(a) Eligibility Determinations.--
        ``(1) In general.--Not later than 60 calendar days after the 
    date of receipt of a request under section 586A, the Secretary 
    shall--
            ``(A) determine, in accordance with paragraph (2), whether 
        the request is eligible for further review under subsection (b) 
        and section 586C;
            ``(B) notify the sponsor of the determination of the 
        Secretary; and
            ``(C) make such determination publicly available in 
        accordance with paragraph (3) and subsection (b)(1).
        ``(2) Criteria for eligibility.--
            ``(A) In general.--To be eligible for review under 
        subsection (b) and section 586C, a request shall be for a 
        nonprescription sunscreen active ingredient or combination of 
        nonprescription sunscreen active ingredients, for use under 
        specified conditions, to be prescribed, recommended, or 
        suggested in the labeling thereof, that--
                ``(i) is not included in part 352 of title 21, Code of 
            Federal Regulations (or any successor regulations) 
            concerning nonprescription sunscreen; and
                ``(ii) has been used to a material extent and for a 
            material time under such conditions, as described in 
            section 201(p)(2).
            ``(B) Establishment of time and extent.--A sponsor shall 
        include in a request under section 586A the information 
        required under section 330.14 of title 21, Code of Federal 
        Regulations (or any successor regulations) to meet the standard 
        described in subparagraph (A)(ii).
        ``(3) Public availability.--
            ``(A) Redactions for confidential information.--If a 
        nonprescription sunscreen active ingredient or combination of 
        nonprescription sunscreen active ingredients is determined 
        under paragraph (1)(A) to be eligible for further review, the 
        Secretary shall make the request publicly available, with 
        redactions for information that is treated as confidential 
        under section 552(b) of title 5, United States Code, section 
        1905 of title 18, United States Code, or section 301(j) of this 
        Act.
            ``(B) Identification of confidential information by 
        sponsor.--At the time that a request is made under section 
        586A, the sponsor of such request shall identify any 
        information that such sponsor considers to be confidential 
        information described in subparagraph (A).
            ``(C) Confidentiality during eligibility review.--The 
        information contained in a request under section 586A shall 
        remain confidential during the Secretary's consideration under 
        this section of whether the request is eligible for further 
        review consistent with section 330.14 of title 21, Code of 
        Federal Regulations (or any successor regulations).
    ``(b) Data Submission and Filing of Requests.--
        ``(1) In general.--In the case of a request under section 586A 
    that is determined to be eligible under subsection (a) for further 
    review under this section and section 586C, the Secretary shall, in 
    notifying the public under subsection (a)(1)(C) of such eligibility 
    determination, post the eligibility determination on the Internet 
    website of the Food and Drug Administration, invite the sponsor of 
    such request and any other interested party to submit comments, and 
    provide a period of not less than 45 calendar days for comments in 
    support of or otherwise relating to a GRASE determination, 
    including published and unpublished data and other information 
    related to the safety and efficacy of such request.
        ``(2) Filing determination.--Not later than 60 calendar days 
    after the submission of data and other information described in 
    paragraph (1) by the sponsor, the Secretary shall determine whether 
    the data and other information submitted by the sponsor under this 
    section are sufficiently complete, including being formatted in a 
    manner that enables the Secretary to determine the completeness of 
    such data and information, to enable the Secretary to conduct a 
    substantive review under section 586C with respect to such request. 
    Not later than 60 calendar days after the submission of data and 
    other information described in paragraph (1) by the sponsor, if the 
    Secretary determines--
            ``(A) that such data and other information are sufficiently 
        complete, the Secretary shall--
                ``(i) issue a written notification to the sponsor of 
            the determination to file such request, and make such 
            notification publicly available; and
                ``(ii) file such request made under section 586A; or
            ``(B) that such data and other information are not 
        sufficiently complete, the Secretary shall issue a written 
        notification to the sponsor of the determination to refuse to 
        file the request, which shall include the reasons for the 
        refusal, including why such data and other information are not 
        sufficiently complete, and make such notification publicly 
        available.
        ``(3) Refusal to file a request.--
            ``(A) Request for meetings; submission of additional data 
        or other information.--If the Secretary refuses to file a 
        request made under section 586A, the sponsor may--
                ``(i) within 30 calendar days of receipt of written 
            notification of such refusal, request, in writing, a 
            meeting with the Secretary regarding the filing 
            determination; and
                ``(ii) submit additional data or other information.
            ``(B) Meetings.--
                ``(i) In general.--If a sponsor seeks a meeting under 
            subparagraph (A)(i), the Secretary shall convene the 
            meeting within 30 calendar days of the request for such 
            meeting.
                ``(ii) Actions after meeting.--Following any meeting 
            held under clause (i)--

                    ``(I) the Secretary may file the request within 60 
                calendar days;
                    ``(II) the sponsor may submit additional data or 
                other information; or
                    ``(III) if the sponsor elects, within 120 calendar 
                days, to have the Secretary file the request (with or 
                without amendments to correct any purported 
                deficiencies to the request)--

                        ``(aa) the Secretary shall file the request 
                    over protest, not later than 30 calendar days after 
                    the sponsor makes such election;
                        ``(bb) at the time of filing, the Secretary 
                    shall provide written notification of such filing 
                    to the sponsor; and
                        ``(cc) the Secretary shall make such 
                    notification publicly available.
                ``(iii) Requests filed over protest.--The Secretary 
            shall not require the sponsor to resubmit a copy of the 
            request for purposes of filing a request filed over 
            protest, as described in clause (ii)(III).
            ``(C) Submissions of additional data or other 
        information.--Within 60 calendar days of any submission of 
        additional data or other information under subparagraph (A)(ii) 
        or (B)(ii)(II), the Secretary shall reconsider the previous 
        determination made under paragraph (2) with respect to the 
        applicable request and make a new determination in accordance 
        with paragraph (2).
        ``(4) Public availability.--
            ``(A) Redactions for confidential information.--After the 
        period of confidentiality described in subsection (a)(3)(C), 
        the Secretary shall make data and other information submitted 
        in connection with a request under section 586A publicly 
        available, with redactions for information that is treated as 
        confidential under section 552(b) of title 5, United States 
        Code, section 1905 of title 18, United States Code, or section 
        301(j) of this Act.
            ``(B) Identification of confidential information by 
        sponsor.--A person submitting information under this section 
        shall identify at the time of such submission the portions of 
        such information that the person considers to be confidential 
        information described in subparagraph (A).
``SEC. 586C. GRASE DETERMINATION.
    ``(a) Review of New Request.--
        ``(1) Proposed sunscreen order.--In the case of a request under 
    section 586A, not later than 300 calendar days after the date on 
    which such request is filed under subsection (b)(2)(A) or 
    (b)(3)(B)(ii)(III) of section 586B, the Secretary--
            ``(A) may convene a meeting of the Advisory Committee to 
        review such request; and
            ``(B) shall complete the review of such request and issue a 
        proposed sunscreen order with respect to such request.
        ``(2) Proposed sunscreen order by commissioner.--If the 
    Secretary does not issue a proposed sunscreen order under paragraph 
    (1)(B) within such 300-day period, the sponsor of such request may 
    notify the Office of the Commissioner of such request and request 
    review by the Office of the Commissioner. If such sponsor so 
    notifies the Office of the Commissioner, the Commissioner shall, 
    not later than 60 calendar days after the date of notification 
    under this paragraph, issue a proposed sunscreen order with respect 
    to such request.
        ``(3) Public comment period.--A proposed sunscreen order issued 
    under paragraph (1)(B) or (2) with respect to a request shall 
    provide for a period of 45 calendar days for public comment.
        ``(4) Meeting.--A sponsor may request, in writing, a meeting 
    with respect to a proposed sunscreen order issued under this 
    subsection and described in subparagraph (B) or (C) of section 
    586(7), not later than 30 calendar days after the Secretary issues 
    such order. The Secretary shall convene a meeting with such sponsor 
    not later than 45 calendar days after such request for a meeting.
        ``(5) Final sunscreen order.--With respect to a proposed 
    sunscreen order under paragraph (1)(B) or (2)--
            ``(A) the Secretary shall issue a final sunscreen order--
                ``(i) in the case of a proposed sunscreen order 
            described in subparagraph (A) or (B) of section 586(7), not 
            later than 90 calendar days after the end of the public 
            comment period under paragraph (3); or
                ``(ii) in the case of a proposed sunscreen order 
            described in subparagraph (C) of section 586(7), not later 
            than 210 calendar days after the date on which the sponsor 
            submits the additional information requested pursuant to 
            such proposed sunscreen order; or
            ``(B) if the Secretary does not issue such final sunscreen 
        order within such 90- or 210-calendar-day period, as 
        applicable, the sponsor of such request may notify the Office 
        of the Commissioner of such request and request review by the 
        Office of the Commissioner.
        ``(6) Final sunscreen order by commissioner.--The Commissioner 
    shall issue a final sunscreen order with respect to a proposed 
    sunscreen order subject to paragraph (5)(B) not later than 60 
    calendar days after the date of notification under such paragraph.
    ``(b) Review of Pending Requests.--
        ``(1) In general.--The review of a pending request shall be 
    carried out by the Secretary in accordance with this subsection.
        ``(2) Inapplicability of sections 586a and 586b.--Sections 586A 
    and 586B shall not apply with respect to any pending request.
        ``(3) Feedback letters as proposed sunscreen order.--
    Notwithstanding the requirements of section 586(7), a letter issued 
    pursuant to section 330.14(g) of title 21, Code of Federal 
    Regulations before the date of enactment of the Sunscreen 
    Innovation Act, with respect to a pending request, shall be deemed 
    to be a proposed sunscreen order and displayed on the Internet 
    website of the Food and Drug Administration. Notification of the 
    availability of such letter shall be published in the Federal 
    Register not later than 45 calendar days after the date of 
    enactment of such Act.
        ``(4) Proposed sunscreen order.--In the case of a pending 
    request for which the Secretary has not issued a letter pursuant to 
    section 330.14(g) of title 21, Code of Federal Regulations before 
    the date of enactment of the Sunscreen Innovation Act, the 
    Secretary shall complete review of such request and, not later than 
    90 calendar days after the date of enactment of such Act, issue a 
    proposed sunscreen order with respect to such request.
        ``(5) Proposed sunscreen order by commissioner.--If the 
    Secretary does not issue a proposed sunscreen order under paragraph 
    (4), or the Secretary does not publish a notification of the 
    availability of a letter under paragraph (3), as applicable, the 
    sponsor of such request may notify the Office of the Commissioner 
    of such request and request review by the Office of the 
    Commissioner. The Commissioner shall, not later than 60 calendar 
    days after the date of notification under this paragraph, issue a 
    proposed order with respect to such request.
        ``(6) Public comment period.--A proposed sunscreen order issued 
    under paragraph (4) or (5), or a notification of the availability 
    of a letter under paragraph (3), with respect to a pending request 
    shall provide for a period of 45 calendar days for public comment.
        ``(7) Meeting.--A sponsor may request, in writing, a meeting 
    with respect to a proposed sunscreen order issued under this 
    subsection, including a letter deemed to be a proposed sunscreen 
    order under paragraph (3), not later than 30 calendar days after 
    the Secretary issues such order or the date upon which such 
    feedback letter is deemed to be a proposed sunscreen order, as 
    applicable. The Secretary shall convene a meeting with such sponsor 
    not later than 45 calendar days after the date of such request for 
    a meeting.
        ``(8) Advisory committee.--In the case of a proposed sunscreen 
    order under paragraph (3), (4), or (5), an Advisory Committee 
    meeting may be convened for the purpose of reviewing and providing 
    recommendations regarding the pending request.
        ``(9) Final sunscreen order.--In the case of a proposed 
    sunscreen order under paragraph (3), (4), or (5)--
            ``(A) the Secretary shall issue a final sunscreen order 
        with respect to the request--
                ``(i) in the case of a proposed sunscreen order 
            described in subparagraph (A) or (B) of section 586(7), not 
            later than 90 calendar days after the end of the public 
            comment period under paragraph (6); or
                ``(ii) in the case of a proposed sunscreen order 
            described in subparagraph (C) of section 586(7)--

                    ``(I) if the Advisory Committee is not convened 
                under paragraph (8), not later than 210 calendar days 
                after the date on which the sponsor submits the 
                additional information requested pursuant to such 
                proposed sunscreen order, which shall include a 
                rationale for not convening such Advisory Committee; or
                    ``(II) if the Advisory Committee is convened under 
                paragraph (8), not later than 270 calendar days after 
                the date on which the sponsor submits such additional 
                information; or

            ``(B) if the Secretary does not issue such final sunscreen 
        order within such 90-, 210-, or 270-calendar-day period, as 
        applicable, the sponsor of such request may notify the Office 
        of the Commissioner about such request and request review by 
        the Office of the Commissioner.
        ``(10) Final sunscreen order by commissioner.--The Commissioner 
    shall issue a final sunscreen order with respect to a proposed 
    sunscreen order subject to paragraph (9)(B) not later than 60 
    calendar days after the date of notification under such paragraph.
    ``(c) Advisory Committee.--The Secretary shall not be required to--
        ``(1) convene the Advisory Committee--
            ``(A) more than once with respect to any request under 
        section 586A or any pending request; or
            ``(B) more than twice in any calendar year with respect to 
        the review under this section; or
        ``(2) submit more than a total of 3 requests under section 586A 
    or pending requests to the Advisory Committee per meeting.
    ``(d) No Delegation.--Any responsibility vested in the Commissioner 
by subsection (a)(2), (a)(6), (b)(5), or (b)(10) shall not be 
delegated.
    ``(e) Effect of Final Sunscreen Order.--
        ``(1) In general.--
            ``(A) Sunscreen active ingredients determined to be 
        grase.--Upon issuance of a final sunscreen order determining 
        that a nonprescription sunscreen active ingredient or 
        combination of nonprescription sunscreen active ingredients is 
        GRASE and is not misbranded, a sunscreen containing such 
        ingredient or combination of ingredients shall be permitted to 
        be introduced or delivered into interstate commerce for use 
        under the conditions described in such final sunscreen order, 
        in accordance with all requirements applicable to drugs not 
        subject to section 503(b)(1), for so long as such final 
        sunscreen order remains in effect.
            ``(B) Sunscreen active ingredients determined not to be 
        grase.--Upon issuance of a final sunscreen order determining 
        that a nonprescription sunscreen active ingredient or 
        combination of nonprescription sunscreen active ingredients is 
        not GRASE and is misbranded, a sunscreen containing such 
        ingredient or combination of ingredients shall not be 
        introduced or delivered into interstate commerce, for use under 
        the conditions described in such final sunscreen order, unless 
        an application is approved pursuant to section 505 with respect 
        to a sunscreen containing such ingredient or combination of 
        ingredients, or unless conditions are later established under 
        which such ingredient or combination of ingredients is later 
        determined to be GRASE and not misbranded under the over-the-
        counter drug monograph system.
        ``(2) Amendments to final sunscreen orders.--
            ``(A) Amendments at initiative of secretary.--In the event 
        that information relevant to a nonprescription sunscreen active 
        ingredient or combination of nonprescription sunscreen active 
        ingredients becomes available to the Secretary after issuance 
        of a final sunscreen order, the Secretary may amend such final 
        sunscreen order by issuing a new proposed sunscreen order under 
        subsection (a)(1) and following the procedures set forth in 
        this section.
            ``(B) Petition to amend final order.--Any interested person 
        may petition the Secretary to amend a final sunscreen order 
        under section 10.30, title 21 Code of Federal Regulations (or 
        any successor regulations). If the Secretary grants any 
        petition under such section, the Secretary shall initiate the 
        process for amending a final sunscreen order by issuing a new 
        proposed sunscreen order under subsection (a)(1) and following 
        the procedures set forth in this section.
            ``(C) Applicability of final orders.--Once the Secretary 
        issues a new proposed sunscreen order to amend a final 
        sunscreen order under subparagraph (A) or (B), such final 
        sunscreen order shall remain in effect and paragraph (3) shall 
        not apply to such final sunscreen order until the Secretary has 
        issued a new final sunscreen order or has determined not to 
        amend the final sunscreen order.
        ``(3) Inclusion of ingredients that are subjects of final 
    orders in the sunscreen monograph.--
            ``(A) Amending regulations.--
                ``(i) Requirement.--At any time that the Secretary 
            proposes to amend part 352 of title 21, Code of Federal 
            Regulations (or any successor regulations) concerning 
            nonprescription sunscreen, including pursuant to section 
            586E, except as provided in clause (iv), the Secretary 
            shall include in such part 352 (or any successor 
            regulations) any nonprescription sunscreen active 
            ingredient or combination of nonprescription sunscreen 
            active ingredients that is the subject of an effective 
            final sunscreen order of the type described in section 
            586(2)(A) and issued since the time that the Secretary last 
            amended such regulations. Such regulation shall set forth 
            conditions of use under which each such ingredient or 
            combination of ingredients is GRASE and not misbranded. If 
            these conditions differ from, or are in addition to, those 
            previously set forth in the applicable final sunscreen 
            order, the Secretary shall provide notice and opportunity 
            for comment on such conditions in the rulemaking, and the 
            applicable final sunscreen order shall continue in effect 
            until the effective date of a final regulation, as set 
            forth in clause (iii).
                ``(ii) Inclusion of orders.--In proposing to amend the 
            regulations as described in clause (i), the Secretary shall 
            include in the proposed regulations a list of final 
            sunscreen orders that shall cease to be effective on the 
            effective date of a resulting final regulation. Such list 
            shall include all final sunscreen orders of the type 
            described in section 586(2)(A) that are in effect on the 
            date that such regulations are proposed, with the exception 
            that such list shall not include any final sunscreen orders 
            that, on the date that the regulations are proposed, the 
            Secretary is in the process of amending under paragraph 
            (2).
                ``(iii) Orders no longer effective.--Any final 
            sunscreen order included by the Secretary in a list 
            described in clause (ii) and in a list included in 
            resulting final regulations shall cease to be effective on 
            the date that such final regulations including such order 
            in such list become effective.
                ``(iv) Ingredients not grase.--If, notwithstanding a 
            final sunscreen order stating that a nonprescription 
            sunscreen active ingredient or combination of 
            nonprescription sunscreen active ingredients is GRASE and 
            is not misbranded if marketed in accordance with such 
            order, while amending the regulations as described in 
            clause (i), the Secretary concludes that such ingredient or 
            combination of ingredients is no longer GRASE for use in 
            nonprescription sunscreen, the Secretary shall, at the 
            discretion of the Secretary, either initiate the process 
            for amending the final sunscreen order set forth in 
            paragraph (2) of this subsection or include in a proposed 
            regulation an explanation and information supporting the 
            determination of the Secretary that such ingredient or 
            combination of ingredients is no longer GRASE for use in 
            nonprescription sunscreen.
            ``(B) Procedure for updating regulations.--After the 
        Secretary amends and finalizes the regulations under part 352 
        of title 21, Code of Federal Regulations under section 586E and 
        such regulations become effective, the Secretary may use direct 
        final rulemaking to include in such regulations any 
        nonprescription sunscreen active ingredients that are the 
        subject of effective final sunscreen orders.
``SEC. 586D. GUIDANCE; OTHER PROVISIONS.
    ``(a) Guidance.--
        ``(1) In general.--
            ``(A) Draft guidance.--Not later than 1 year after the date 
        of enactment of the Sunscreen Innovation Act, the Secretary 
        shall issue draft guidance on the implementation of, and 
        compliance with, the requirements with respect to sunscreen 
        under this subchapter, including guidance on--
                ``(i) the format and content of information submitted 
            by a sponsor in support of a request under section 586A or 
            a pending request;
                ``(ii) the data required to meet the safety and 
            efficacy standard for determining whether a nonprescription 
            sunscreen active ingredient or combination of 
            nonprescription sunscreen active ingredients is GRASE and 
            is not misbranded;
                ``(iii) the process by which a request under section 
            586A or a pending request is withdrawn; and
                ``(iv) the process by which the Secretary will carry 
            out section 586C(c), including with respect to how the 
            Secretary will address the total number of requests 
            received under section 586A and pending requests.
            ``(B) Final guidance.--The Secretary shall finalize the 
        guidance described in subparagraph (A) not later than 2 years 
        after the date of enactment of the Sunscreen Innovation Act.
            ``(C) Inapplicability of paperwork reduction act.--Chapter 
        35 of title 44, United States Code shall not apply to 
        collections of information made for purposes of guidance under 
        this subsection.
        ``(2) Submissions pending issuance of final guidance.--
    Irrespective of whether final guidance under paragraph (1) has been 
    issued--
            ``(A) persons may, beginning on the date of enactment of 
        the Sunscreen Innovation Act, make submissions under this 
        subchapter; and
            ``(B) the Secretary shall review and act upon such 
        submissions in accordance with this subchapter.
    ``(b) Rules of Construction.--
        ``(1) Currently marketed sunscreens.--Nothing in this 
    subchapter shall be construed to affect the marketing of sunscreens 
    that are marketed in interstate commerce on or before the date of 
    enactment of this subchapter, except as otherwise provided in this 
    subchapter.
        ``(2) Ensuring safety and effectiveness.--Nothing in this 
    subchapter shall be construed to alter the authority of the 
    Secretary with respect to prohibiting the marketing of a sunscreen 
    that is not safe and effective or is misbranded, or with respect to 
    imposing restrictions on the marketing of a sunscreen to ensure 
    safety and effectiveness, except as otherwise provided in this 
    subchapter, including section 586C(e).
        ``(3) Other drugs.--Except as otherwise provided in section 
    586F, nothing in this subchapter shall be construed to affect the 
    authority of the Secretary under this Act or the Public Health 
    Service Act (42 U.S.C. 201 et seq.) with respect to a drug other 
    than a nonprescription sunscreen.
        ``(4) Effect on drugs otherwise approved.--Nothing in this 
    subchapter shall affect the marketing of a drug approved under 
    section 505 of this Act or section 351 of the Public Health Service 
    Act.
    ``(c) Timelines.--The timelines for the processes and procedures 
under paragraphs (1), (2), (5), and (6) of section 586C(a) shall not 
apply to any requests submitted to the Secretary under section 586A 
after the date that is 6 years after the date of enactment of the 
Sunscreen Innovation Act.
``SEC. 586E. SUNSCREEN MONOGRAPH.
    ``(a) In General.--Not later than 5 years after the date of 
enactment of the Sunscreen Innovation Act, the Secretary shall amend 
and finalize regulations under part 352 of title 21, Code of Federal 
Regulations concerning nonprescription sunscreen that are effective not 
later than 5 years after such date of enactment. The Secretary shall 
publish such regulations not less than 30 calendar days before the 
effective date of such regulations.
    ``(b) Reports.--If the regulations promulgated under subsection (a) 
do not include provisions related to the effectiveness of various sun 
protection factor levels, and do not address all dosage forms known to 
the Secretary to be used in sunscreens marketed in the United States 
without a new drug approval under section 505, the Secretary shall 
submit a report to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and Commerce of the 
House of Representatives on the rationale for such provisions not being 
included in such regulations, and a plan and timeline to compile any 
information necessary to address such provisions through final 
regulations.''.
    (b) Rules of Construction.--Nothing in the amendment made by this 
section shall be construed to--
        (1) limit the right of a sponsor (as defined in section 586(8) 
    of the Federal Food, Drug, and Cosmetic Act, as added by subsection 
    (a)) to request that the Secretary of Health and Human Services 
    convene an advisory committee; or
        (2) limit the authority of the Secretary of Health and Human 
    Services to meet with a sponsor (as defined in section 586(8) of 
    the Federal Food, Drug, and Cosmetic Act, as added by subsection 
    (a)).
SEC. 3. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS.
    Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic 
Act, as added by section 2, is amended by adding at the end the 
following:
``SEC. 586F. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS.
    ``(a) Pending Time and Extent Applications.--
        ``(1) In general.--
            ``(A) Request for framework for review.--If, prior to the 
        date of enactment of the Sunscreen Innovation Act, an 
        application was submitted pursuant to section 330.14 of title 
        21, Code of Federal Regulations for a GRASE determination for a 
        drug other than a nonprescription sunscreen active ingredient 
        or combination of nonprescription sunscreen active ingredients 
        and such drug was found to be eligible to be considered for 
        inclusion in the over-the-counter drug monograph system 
        pursuant to section 330.14 of title 21, Code of Federal 
        Regulations, the sponsor of such application may request that 
        the Secretary provide a framework under paragraph (2) for the 
        review of such application.
            ``(B) Request requirements.--A request for a framework for 
        review of an application made under subparagraph (A) shall be 
        made within 180 calendar days of the date of enactment of the 
        Sunscreen Innovation Act and shall include the preference of 
        such sponsor as to whether such application is reviewed by the 
        Secretary in accordance with--
                ``(i) the processes and procedures set forth for 
            pending requests under section 586C(b), except that 
            specific timelines shall be determined in accordance with 
            other applicable requirements under this section;
                ``(ii) the processes and procedures set forth under 
            part 330 of title 21, Code of Federal Regulations (or any 
            successor regulations);
                ``(iii) an initial filing determination under the 
            processes and procedures described in section 586B(b) and 
            the processes and procedures set forth for pending requests 
            under section 586C(b), except that specific timelines shall 
            be determined in accordance with other applicable 
            requirements under this section; or
                ``(iv) an initial filing determination under the 
            processes and procedures described in section 586B(b) and 
            the processes and procedures set forth under part 330 of 
            title 21, Code of Federal Regulations (or any successor 
            regulations).
            ``(C) No request.--If a sponsor described in subparagraph 
        (A) does not make such request within 180 calendar days of the 
        date of enactment of the Sunscreen Innovation Act, such 
        application shall be reviewed by the Secretary in accordance 
        with the timelines of the applicable regulations when such 
        regulations are finalized under subsection (b).
        ``(2) Framework.--Not later than 1 year after the date of 
    enactment of the Sunscreen Innovation Act, the Secretary shall 
    provide, in writing, a framework to each sponsor that submitted a 
    request under paragraph (1). Such framework shall set forth the 
    various timelines, in calendar days, with respect to the processes 
    and procedures for review under clauses (i), (ii), (iii), and (iv) 
    of paragraph (1)(B) and--
            ``(A) such timelines shall account for the considerations 
        under paragraph (5); and
            ``(B) the timelines for the various processes and 
        procedures shall not be shorter than the timelines set forth 
        for pending requests under sections 586B(b) and 586C(b), as 
        applicable.
        ``(3) Governing processes and procedures for review.--
            ``(A) Election.--Not later than 60 calendar days after the 
        Secretary provides a framework to a sponsor under paragraph 
        (2), such sponsor may provide an election to the Secretary 
        regarding the processes and procedures for review under clause 
        (i), (ii), (iii), or (iv) of paragraph (1)(B). If such sponsor 
        makes such election, the Secretary shall review the application 
        that is the subject of such election pursuant to the processes 
        and procedures elected by such sponsor and the applicable 
        timelines in calendar days set forth under such framework, 
        which the Secretary shall confirm in writing to the sponsor not 
        later than the date upon which the Secretary provides a report 
        under paragraph (4). If such sponsor does not make such 
        election, such application shall be reviewed by the Secretary 
        in accordance with the timelines of the applicable regulations 
        when such regulations are finalized under subsection (b).
            ``(B) Different processes and procedures.--At any time 
        during review of an application, the Secretary may review such 
        application under different processes and procedures under 
        clause (i), (ii), (iii), or (iv) of paragraph (1)(B) than the 
        processes and procedures the sponsor elected in accordance with 
        subparagraph (A), so long as the Secretary proposes, in 
        writing, the change and the sponsor agrees, in writing, to such 
        change.
            ``(C) Inclusion of ingredients in monographs.--If the 
        sponsor elects to use the processes and procedures for review 
        in accordance with clause (i) or (iii) of paragraph (1)(B), the 
        Secretary may incorporate any resulting final order into a 
        regulation addressing the conditions under which other drugs in 
        the same therapeutic category are GRASE and not misbranded, 
        including through direct final rulemaking, and the final order 
        so incorporated shall cease to be effective on the effective 
        date of the final regulation that addresses such drug.
        ``(4) Letter regarding pending applications.--Not later than 18 
    months after the date of enactment of the Sunscreen Innovation Act, 
    the Secretary shall report to the Committee on Health, Education, 
    Labor, and Pensions of the Senate and the Committee on Energy and 
    Commerce of the House of Representatives, in writing, regarding all 
    pending applications subject to paragraph (1). In such letter, the 
    Secretary shall provide a report on the review of such 
    applications, including the timelines, in calendar days, for the 
    review and GRASE determination for each application. Such timelines 
    shall account for the considerations under paragraph (5).
        ``(5) Timelines.--The timelines in calendar days established by 
    the Secretary pursuant to this subsection--
            ``(A) may vary based on the content, complexity, and format 
        of the application submitted to the Secretary; and
            ``(B) shall--
                ``(i) reflect the public health priorities of the Food 
            and Drug Administration, including the potential public 
            health benefits posed by the inclusion of additional drugs 
            in the over-the-counter drug monograph system;
                ``(ii) take into consideration the resources available 
            to the Secretary for carrying out such priorities and the 
            processes and procedures described in paragraphs (1)(B) and 
            (2); and
                ``(iii) be reasonable, taking into consideration the 
            requirements described in clauses (i) and (ii).
    ``(b) New Time and Extent Applications.--
        ``(1) In general.--Not later than 18 months after the date of 
    enactment of the Sunscreen Innovation Act, the Secretary shall 
    issue proposed regulations establishing timelines for the review of 
    applications for GRASE determinations for drugs other than 
    nonprescription sunscreen active ingredients or combinations of 
    nonprescription sunscreen active ingredients that are submitted to 
    the Secretary after the date of enactment of the Sunscreen 
    Innovation Act, under section 330.14 of title 21, Code of Federal 
    Regulations (or any successor regulations), and that are found to 
    be eligible to be considered for inclusion in the over-the-counter 
    drug monograph system pursuant to section 330.14 of title 21, Code 
    of Federal Regulations (or any successor regulations), or that are 
    subject to this subsection pursuant to paragraph (1) or (3) of 
    subsection (a), as applicable, providing--
            ``(A) timely and efficient completion of evaluations of 
        applications under section 330.14 of title 21, Code of Federal 
        Regulations (or any successor regulations) for drugs other than 
        sunscreens; and
            ``(B) timely and efficient completion of the review of the 
        safety and effectiveness submissions pursuant to such 
        applications, including establishing--
                ``(i) reasonable timelines, in calendar days, for the 
            applicable proposed and final regulations for applications 
            of various content, complexity, and format, and timelines 
            for internal procedures related to such processes; and
                ``(ii) measurable metrics for tracking the extent to 
            which the timelines set forth in the regulations are met.
        ``(2) Timelines.--The timelines in calendar days established in 
    the regulations under paragraph (1)--
            ``(A) may vary based on the content, complexity, and format 
        of the application submitted to the Secretary; and
            ``(B) shall--
                ``(i) reflect the public health priorities of the Food 
            and Drug Administration, including the potential public 
            health benefits posed by the inclusion of additional drugs 
            in the over-the-counter drug monograph system;
                ``(ii) take into consideration the resources available 
            to the Secretary for carrying out such priorities and the 
            processes and procedures described in paragraph (1); and
                ``(iii) be reasonable, taking into consideration the 
            requirements described in clauses (i) and (ii).
        ``(3) Procedure.--In promulgating regulations under this 
    subsection, the Secretary shall issue a notice of proposed 
    rulemaking that includes a copy of the proposed regulation, provide 
    a period of not less than 60 calendar days for comments on the 
    proposed regulation, and publish the final regulation not less than 
    30 calendar days before the effective date of the regulation.
        ``(4) Restrictions.--Notwithstanding any other provision of 
    law, the Secretary shall promulgate regulations implementing this 
    section only as described in paragraphs (1), (2), and (3).
        ``(5) Final regulations.--The Secretary shall finalize the 
    regulations under this section not later than 27 months after the 
    date of enactment of the Sunscreen Innovation Act.''.
SEC. 4. REPORTS.
    (a) Initial GAO Report.--Not later than 3 years after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report reviewing the overall progress of the 
Secretary of Health and Human Services in carrying out subchapter I of 
chapter V of the Federal Food, Drug, and Cosmetic Act (as added by 
section 2 and amended by section 3 and subsection (c)), including 
findings on and recommendations with respect to--
        (1) the progress made in completing the review of requests 
    under subchapter I of chapter V of the Federal Food, Drug, and 
    Cosmetic Act, including pending requests, and the feasibility of 
    the timelines associated with such subchapter;
        (2) the role of the Office of the Commissioner of Food and 
    Drugs in issuing determinations with respect to requests reviewed 
    under such subchapter, including the number of requests transferred 
    to the Office of the Commissioner under section 586C of such Act;
        (3) the extent to which advisory committees were convened by 
    the Secretary regarding requests under subchapter I of chapter V of 
    the Federal Food, Drug, and Cosmetic Act, including pending 
    requests; and
        (4) the types of metrics that have been, or should be, 
    established for the review of time and extent applications.
    (b) Subsequent GAO Report.--Not later than 5\1/2\ years after the 
date of enactment of this Act, the Comptroller General of the United 
States shall submit to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and Commerce of the 
House of Representatives a report reviewing the overall progress of the 
Secretary of Health and Human Services in carrying out subchapter I of 
chapter V of the Federal Food, Drug, and Cosmetic Act (as added by 
section 2 and amended by section 3 and subsection (c)) and the 
regulation of over-the-counter drug products, including findings on and 
recommendations with respect to--
        (1) updates on the matters reported on by the Comptroller 
    General under subsection (a);
        (2) significant factors impacting the ability of the Food and 
    Drug Administration to fulfill the mission of the agency with 
    regard to the regulation of over-the-counter drug products, 
    including finalizing outstanding monographs and responding to 
    emerging and novel safety issues;
        (3) the performance of the Secretary in carrying out section 
    586E of the Federal Food, Drug, and Cosmetic Act;
        (4) the types of metrics that have been, or should be, 
    established for the review and regulation of over-the-counter drug 
    products; and
        (5) timeliness, efficiency, and accountability in reviewing 
    time and extent applications and safety and effectiveness reviews 
    for over-the-counter drug products.
    (c) FDA Report.--Subchapter I of chapter V of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 3, is further amended by 
adding at the end the following:
``SEC. 586G. REPORT.
    ``(a) In General.--
        ``(1) In general.--Not later than 18 months after the date of 
    enactment of the Sunscreen Innovation Act, and on the dates that 
    are 2 and 4 years thereafter, the Secretary shall issue a report to 
    the Committee on Health, Education, Labor, and Pensions of the 
    Senate and the Committee on Energy and Commerce of the House of 
    Representatives describing actions taken under this subchapter.
        ``(2) Contents.--The reports under this subsection shall 
    include--
            ``(A) a review of the progress made in issuing GRASE 
        determinations for pending requests, including the number of 
        pending requests--
                ``(i) reviewed and the decision times for each request, 
            measured from the date of the original request for an 
            eligibility determination submitted by the sponsor;
                ``(ii) resulting in a determination that the 
            nonprescription sunscreen active ingredient or combination 
            of nonprescription sunscreen active ingredients is GRASE 
            and is not misbranded;
                ``(iii) resulting in a determination that the 
            nonprescription sunscreen active ingredient or combination 
            of nonprescription sunscreen active ingredients is not 
            GRASE and is misbranded and the reasons for such 
            determinations; and
                ``(iv) for which a determination has not been made, and 
            an explanation for the delay, a description of the current 
            status of each such request, and the length of time each 
            such request has been pending, measured from the date of 
            original request for an eligibility determination by the 
            sponsor;
            ``(B) a review of the progress made in issuing GRASE 
        determinations for requests not included in the reporting under 
        subparagraph (A), including the number of such requests--
                ``(i) reviewed and the decision times for each request;
                ``(ii) resulting in a determination that the 
            nonprescription sunscreen active ingredient, combination of 
            nonprescription sunscreen active ingredients, or other 
            ingredient is GRASE and is not misbranded;
                ``(iii) resulting in a determination that the 
            nonprescription sunscreen active ingredient, combination of 
            nonprescription sunscreen active ingredients, or other 
            ingredient is not GRASE and is misbranded and the reasons 
            for such determinations; and
                ``(iv) for which a determination has not been made, and 
            an explanation for the delay, a description of the current 
            status of each such request, and the length of time each 
            such request has been pending, measured from the date of 
            original request for an eligibility determination by the 
            sponsor;
            ``(C) an annual accounting (including information from 
        years prior to the date of enactment of the Sunscreen 
        Innovation Act where such information is available) of the 
        total number of requests submitted, pending, or completed under 
        this subchapter, including whether such requests were the 
        subject of an advisory committee convened by the Secretary;
            ``(D) a description of the staffing and resources relating 
        to the costs associated with the review and decisionmaking 
        pertaining to requests under this subchapter;
            ``(E) a review of the progress made in meeting the 
        deadlines with respect to processing requests under this 
        subchapter; and
            ``(F) to the extent the Secretary determines appropriate, 
        recommendations for process improvements in the handling of 
        requests under this subchapter, including the advisory 
        committee review process.
    ``(b) Method.--The Secretary shall publish the reports under 
subsection (a) in the manner the Secretary determines to be the most 
effective for efficiently disseminating the report, including 
publication of the report on the Internet website of the Food and Drug 
Administration.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```