[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2141 Engrossed in Senate (ES)]

113th CONGRESS
  2d Session
                                S. 2141

_______________________________________________________________________

                                 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.''.

            Passed the Senate September 17 (legislative day, September 
      16), 2014.

            Attest:

                                                             Secretary.
113th CONGRESS

  2d Session

                                S. 2141

_______________________________________________________________________

                                 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.