Text: S.2141 — 113th Congress (2013-2014)All Bill Information (Except Text)

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Public Law No: 113-195 (11/26/2014)




[113th Congress Public Law 195]
[From the U.S. Government Printing Office]



[[Page 128 STAT. 2035]]

Public Law 113-195
113th Congress

                                 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. <<NOTE: Nov. 26, 2014 -  [S. 2141]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Sunscreen 
Innovation Act.>> 
SECTION 1. <<NOTE: 21 USC 301 note.>>  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. <<NOTE: 21 USC 360fff.>>  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);

[[Page 128 STAT. 2036]]

            ``(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. <<NOTE: 21 USC 360fff-1.>> 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. <<NOTE: 21 USC 360fff-2.>>  ELIGIBILITY 
                          DETERMINATIONS; DATA SUBMISSION; FILING.

    ``(a) Eligibility Determinations.--
            ``(1) <<NOTE: Deadline.>>  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) <<NOTE: Notification.>>  notify the sponsor of 
                the determination of the Secretary; and

[[Page 128 STAT. 2037]]

                    ``(C) <<NOTE: Public information.>>  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) <<NOTE: Web posting. Deadline.>>  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) <<NOTE: Deadlines.>>  Filing determination.--Not later 
        than 60 calendar days after the submission of data and other 
        information

[[Page 128 STAT. 2038]]

        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) <<NOTE: Notification. Public information.>>  
                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) <<NOTE: Deadlines.>>  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) <<NOTE: Notification.>>  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) <<NOTE: Notification.>>  
                                        at the time of filing, the 
                                        Secretary shall provide written 
                                        notification of such filing to 
                                        the sponsor; and
                                            ``(cc) <<NOTE: Public 
                                        information.>>  the Secretary 
                                        shall make such notification 
                                        publicly available.

[[Page 128 STAT. 2039]]

                          ``(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. <<NOTE: 21 USC 360fff-3.>>  GRASE DETERMINATION.

    ``(a) <<NOTE: Deadlines.>>  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.

[[Page 128 STAT. 2040]]

            ``(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) <<NOTE: Deadlines.>>  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) <<NOTE: Web posting.>>  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 <<NOTE: Notification. Federal Register, 
        publication.>>  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.

[[Page 128 STAT. 2041]]

            ``(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) <<NOTE: Notification.>>  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

[[Page 128 STAT. 2042]]

            ``(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

[[Page 128 STAT. 2043]]

                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. <<NOTE: Notification. Public 
                      comments. Extension.>>  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) <<NOTE: Lists. Termination date.>>  
                      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,

[[Page 128 STAT. 2044]]

                      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. <<NOTE: 21 USC 360fff-4.>>  GUIDANCE; OTHER 
                          PROVISIONS.

    ``(a) Guidance.--
            ``(1) In general.--
                    ``(A) <<NOTE: Deadline.>>  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) <<NOTE: Deadline.>>  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) <<NOTE: Review.>>  the Secretary shall review 
                and act upon such submissions in accordance with this 
                subchapter.

    ``(b) Rules of Construction.--

[[Page 128 STAT. 2045]]

            ``(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. <<NOTE: 21 USC 360fff-5.>>  SUNSCREEN MONOGRAPH.

    ``(a) <<NOTE: Deadlines. Regulations.>>  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 <<NOTE: Publication.>>  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) <<NOTE: 21 USC 360 note.>>  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)).

[[Page 128 STAT. 2046]]

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. <<NOTE: 21 USC 360fff-6.>>  NON-SUNSCREEN TIME AND 
                          EXTENT APPLICATIONS.

    ``(a) <<NOTE: Deadlines.>>  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) <<NOTE: Deadline. Notification.>>  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

[[Page 128 STAT. 2047]]

        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--

[[Page 128 STAT. 2048]]

                    ``(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) <<NOTE: Deadline. Regulations. Drugs and drug 
        abuse.>>  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

[[Page 128 STAT. 2049]]

                      the processes and procedures described in 
                      paragraph (1); and
                          ``(iii) be reasonable, taking into 
                      consideration the requirements described in 
                      clauses (i) and (ii).
            ``(3) <<NOTE: Notice. Records. Time periods.>>  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) <<NOTE: Regulations.>>  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) <<NOTE: Deadline.>>  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--

[[Page 128 STAT. 2050]]

            (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. <<NOTE: 21 USC 360fff-7.>>  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--

[[Page 128 STAT. 2051]]

                          ``(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) <<NOTE: Publication. Web posting.>>  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.''.

    Approved November 26, 2014.

LEGISLATIVE HISTORY--S. 2141 (H.R. 4250):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 113-558 (Comm. on Energy and Commerce) accompanying 
H.R. 4250.
CONGRESSIONAL RECORD, Vol. 160 (2014):
            Sept. 17, considered and passed Senate.
            Nov. 13, considered and passed House.

                                  <all>