    [United States Statutes at Large, Volume 128, 113th Congress, 2nd Session]
    [From the U.S. Government Publishing Office, www.gpo.gov]

    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. <>

    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);

    [[Page 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. <> 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

    [[Page 2037]]

    ``(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

    [[Page 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) <>
    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.

    [[Page 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. <>  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.

    [[Page 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) <>  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.

    [[Page 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) <>  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 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 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. <>  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,

    [[Page 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. <>  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.--

    [[Page 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. <>  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)).

    [[Page 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. <>  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

    [[Page 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 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) <>  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 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) <>  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--

    [[Page 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. <>  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 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) <>  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.