[Congressional Record (Bound Edition), Volume 160 (2014), Part 10]
[Senate]
[Pages 14998-15002]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        SUNSCREEN INNOVATION ACT

  Mr. REID. Mr. President, I ask unanimous consent that the Senate 
proceed to the consideration of Calendar No. 568, S. 2141.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The assistant bill clerk read as follows:

       A bill (S. 2141) 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.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

                                S. 2141

     SECTION 1. SHORT TITLE.

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

     SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE 
                   INGREDIENTS.

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

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

     ``SEC. 586. DEFINITIONS.

       ``In this subchapter--
       ``(1) the term `Advisory Committee' means the 
     Nonprescription Drug Advisory Committee of the Food and Drug 
     Administration or any successor to such Committee;
       ``(2) the term `final sunscreen order' means an order 
     published by the Secretary in the Federal Register containing 
     information stating that a nonprescription sunscreen active 
     ingredient or combination of nonprescription sunscreen active 
     ingredients--
       ``(A) is GRASE and is not misbranded if marketed in 
     accordance with such order; or
       ``(B) is not GRASE and is misbranded;
       ``(3) the term `GRASE' means generally recognized, among 
     experts qualified by scientific training and experience to 
     evaluate the safety and effectiveness of drugs, as safe and 
     effective for use under the conditions prescribed, 
     recommended, or suggested in the labeling of a drug as 
     described in section 201(p);
       ``(4) the term `GRASE determination' means, with respect to 
     a nonprescription active ingredient or a combination of 
     nonprescription active ingredients, a determination of 
     whether such ingredient or combination of ingredients is 
     GRASE;
       ``(5) the term `nonprescription' means not subject to 
     section 503(b)(1);
       ``(6) the term `pending request' means each request with 
     respect to a nonprescription sunscreen active ingredient 
     submitted under section 330.14 of title 21, Code of Federal 
     Regulations (as in effect on the date of enactment of the 
     Sunscreen Innovation Act) for consideration for inclusion in 
     the over-the-counter drug monograph system--
       ``(A) that was determined to be eligible for such review by 
     publication of a notice of eligibility in the Federal 
     Register prior to the date of enactment of such Act; and
       ``(B) for which safety and effectiveness data have been 
     submitted to the Secretary prior to such date of enactment;
       ``(7) the term `proposed sunscreen order' means an order 
     containing a tentative determination published by the 
     Secretary in the Federal Register containing information 
     proposing that a nonprescription sunscreen active ingredient 
     or combination of nonprescription sunscreen active 
     ingredients--
       ``(A) is GRASE and is not misbranded if marketed in 
     accordance with such order;
       ``(B) is not GRASE and is misbranded; or
       ``(C) is not GRASE and is misbranded because the data are 
     insufficient to classify such ingredient or combination of 
     ingredients as GRASE and not misbranded and additional 
     information is necessary to allow the Secretary to determine 
     otherwise;
       ``(8) the term `sponsor' means the person that submitted--
       ``(A) a request under section 586A;
       ``(B) a pending request; or
       ``(C) any other application subject to this subchapter;
       ``(9) the term `sunscreen' means a drug containing one or 
     more sunscreen active ingredients; and
       ``(10) the term `sunscreen active ingredient' means an 
     active ingredient that is intended for application to the 
     skin of humans for purposes of absorbing, reflecting, or 
     scattering ultraviolet radiation.

     ``SEC. 586A. SUBMISSION OF REQUESTS.

       ``Any person may submit a request to the Secretary for a 
     determination of whether a nonprescription sunscreen active 
     ingredient or a combination of nonprescription sunscreen 
     active ingredients, for use under specified conditions, to be 
     prescribed, recommended, or suggested in the labeling thereof 
     (including dosage form, dosage strength, and route of 
     administration) is GRASE and should be included in part 352 
     of title 21, Code of Federal Regulations (or any successor 
     regulations) concerning nonprescription sunscreen.

     ``SEC. 586B. ELIGIBILITY DETERMINATIONS; DATA SUBMISSION; 
                   FILING.

       ``(a) Eligibility Determinations.--
       ``(1) In general.--Not later than 60 calendar days after 
     the date of receipt of a request under section 586A, the 
     Secretary shall--
       ``(A) determine, in accordance with paragraph (2), whether 
     the request is eligible for further review under subsection 
     (b) and section 586C;
       ``(B) notify the sponsor of the determination of the 
     Secretary; and
       ``(C) make such determination publicly available in 
     accordance with paragraph (3) and subsection (b)(1).
       ``(2) Criteria for eligibility.--
       ``(A) In general.--To be eligible for review under 
     subsection (b) and section 586C, a request shall be for a 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients, for use under 
     specified conditions, to be prescribed, recommended, or 
     suggested in the labeling thereof, that--
       ``(i) is not included in part 352 of title 21, Code of 
     Federal Regulations (or any successor regulations) concerning 
     nonprescription sunscreen; and
       ``(ii) has been used to a material extent and for a 
     material time under such conditions, as described in section 
     201(p)(2).
       ``(B) Establishment of time and extent.--A sponsor shall 
     include in a request under section 586A the information 
     required under section 330.14 of title 21, Code of Federal 
     Regulations (or any successor regulations) to meet the 
     standard described in subparagraph (A)(ii).
       ``(3) Public availability.--
       ``(A) Redactions for confidential information.--If a 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients is determined 
     under paragraph (1)(A) to be eligible for further review, the 
     Secretary shall make the request publicly available, with 
     redactions for information that is treated as confidential 
     under section 552(b) of title 5, United States Code, section 
     1905 of title 18, United States Code, or section 301(j) of 
     this Act.
       ``(B) Identification of confidential information by 
     sponsor.--At the time that a request is made under section 
     586A, the sponsor of such request shall identify any 
     information that such sponsor considers to be confidential 
     information described in subparagraph (A).
       ``(C) Confidentiality during eligibility review.--The 
     information contained in a request under section 586A shall 
     remain confidential during the Secretary's consideration 
     under this section of whether the request is eligible for 
     further review consistent with section 330.14 of title 21, 
     Code of Federal Regulations (or any successor regulations).
       ``(b) Data Submission and Filing of Requests.--
       ``(1) In general.--In the case of a request under section 
     586A that is determined to be eligible under subsection (a) 
     for further review under this section and section 586C, the 
     Secretary shall, in notifying the public under subsection 
     (a)(1)(C) of such eligibility determination, post the 
     eligibility determination on the Internet website of the Food 
     and Drug Administration, invite the sponsor of such request 
     and any other interested party to submit comments, and 
     provide a period of not less than 45 calendar days for 
     comments in support of or otherwise relating to a GRASE 
     determination, including published and unpublished data and 
     other information related to the safety and efficacy of such 
     request.
       ``(2) Filing determination.--Not later than 60 calendar 
     days after the submission of data and other information 
     described in paragraph (1) by the sponsor, the Secretary 
     shall determine whether the data and other information 
     submitted by the sponsor under this section are sufficiently 
     complete, including being formatted in a manner that enables 
     the Secretary to determine the completeness of such data and 
     information, to enable the Secretary to conduct a substantive 
     review under section 586C with respect to such request. Not 
     later than 60 calendar days after the submission of data and 
     other information described in paragraph (1) by the sponsor, 
     if the Secretary determines--

[[Page 14999]]

       ``(A) that such data and other information are sufficiently 
     complete, the Secretary shall--
       ``(i) issue a written notification to the sponsor of the 
     determination to file such request, and make such 
     notification publicly available; and
       ``(ii) file such request made under section 586A; or
       ``(B) that such data and other information are not 
     sufficiently complete, the Secretary shall issue a written 
     notification to the sponsor of the determination to refuse to 
     file the request, which shall include the reasons for the 
     refusal, including why such data and other information are 
     not sufficiently complete, and make such notification 
     publicly available.
       ``(3) Refusal to file a request.--
       ``(A) Request for meetings; submission of additional data 
     or other information.--If the Secretary refuses to file a 
     request made under section 586A, the sponsor may--
       ``(i) within 30 calendar days of receipt of written 
     notification of such refusal, request, in writing, a meeting 
     with the Secretary regarding the filing determination; and
       ``(ii) submit additional data or other information.
       ``(B) Meetings.--
       ``(i) In general.--If a sponsor seeks a meeting under 
     subparagraph (A)(i), the Secretary shall convene the meeting 
     within 30 calendar days of the request for such meeting.
       ``(ii) Actions after meeting.--Following any meeting held 
     under clause (i)--

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

       ``(aa) the Secretary shall file the request over protest, 
     not later than 30 calendar days after the sponsor makes such 
     election;
       ``(bb) at the time of filing, the Secretary shall provide 
     written notification of such filing to the sponsor; and
       ``(cc) the Secretary shall make such notification publicly 
     available.
       ``(iii) Requests filed over protest.--The Secretary shall 
     not require the sponsor to resubmit a copy of the request for 
     purposes of filing a request filed over protest, as described 
     in clause (ii)(III).
       ``(C) Submissions of additional data or other 
     information.--Within 60 calendar days of any submission of 
     additional data or other information under subparagraph 
     (A)(ii) or (B)(ii)(II), the Secretary shall reconsider the 
     previous determination made under paragraph (2) with respect 
     to the applicable request and make a new determination in 
     accordance with paragraph (2).
       ``(4) Public availability.--
       ``(A) Redactions for confidential information.--After the 
     period of confidentiality described in subsection (a)(3)(C), 
     the Secretary shall make data and other information submitted 
     in connection with a request under section 586A publicly 
     available, with redactions for information that is treated as 
     confidential under section 552(b) of title 5, United States 
     Code, section 1905 of title 18, United States Code, or 
     section 301(j) of this Act.
       ``(B) Identification of confidential information by 
     sponsor.--A person submitting information under this section 
     shall identify at the time of such submission the portions of 
     such information that the person considers to be confidential 
     information described in subparagraph (A).

     ``SEC. 586C. GRASE DETERMINATION.

       ``(a) Review of New Request.--
       ``(1) Proposed sunscreen order.--In the case of a request 
     under section 586A, not later than 300 calendar days after 
     the date on which such request is filed under subsection 
     (b)(2)(A) or (b)(3)(B)(ii)(III) of section 586B, the 
     Secretary--
       ``(A) may convene a meeting of the Advisory Committee to 
     review such request; and
       ``(B) shall complete the review of such request and issue a 
     proposed sunscreen order with respect to such request.
       ``(2) Proposed sunscreen order by commissioner.--If the 
     Secretary does not issue a proposed sunscreen order under 
     paragraph (1)(B) within such 300-day period, the sponsor of 
     such request may notify the Office of the Commissioner of 
     such request and request review by the Office of the 
     Commissioner. If such sponsor so notifies the Office of the 
     Commissioner, the Commissioner shall, not later than 60 
     calendar days after the date of notification under this 
     paragraph, issue a proposed sunscreen order with respect to 
     such request.
       ``(3) Public comment period.--A proposed sunscreen order 
     issued under paragraph (1)(B) or (2) with respect to a 
     request shall provide for a period of 45 calendar days for 
     public comment.
       ``(4) Meeting.--A sponsor may request, in writing, a 
     meeting with respect to a proposed sunscreen order issued 
     under this subsection and described in subparagraph (B) or 
     (C) of section 586(7), not later than 30 calendar days after 
     the Secretary issues such order. The Secretary shall convene 
     a meeting with such sponsor not later than 45 calendar days 
     after such request for a meeting.
       ``(5) Final sunscreen order.--With respect to a proposed 
     sunscreen order under paragraph (1)(B) or (2)--
       ``(A) the Secretary shall issue a final sunscreen order--
       ``(i) in the case of a proposed sunscreen order described 
     in subparagraph (A) or (B) of section 586(7), not later than 
     90 calendar days after the end of the public comment period 
     under paragraph (3); or
       ``(ii) in the case of a proposed sunscreen order described 
     in subparagraph (C) of section 586(7), not later than 210 
     calendar days after the date on which the sponsor submits the 
     additional information requested pursuant to such proposed 
     sunscreen order; or
       ``(B) if the Secretary does not issue such final sunscreen 
     order within such 90- or 210-calendar-day period, as 
     applicable, the sponsor of such request may notify the Office 
     of the Commissioner of such request and request review by the 
     Office of the Commissioner.
       ``(6) Final sunscreen order by commissioner.--The 
     Commissioner shall issue a final sunscreen order with respect 
     to a proposed sunscreen order subject to paragraph (5)(B) not 
     later than 60 calendar days after the date of notification 
     under such paragraph.
       ``(b) Review of Pending Requests.--
       ``(1) In general.--The review of a pending request shall be 
     carried out by the Secretary in accordance with this 
     subsection.
       ``(2) Inapplicability of sections 586a and 586b.--Sections 
     586A and 586B shall not apply with respect to any pending 
     request.
       ``(3) Feedback letters as proposed sunscreen order.--
     Notwithstanding the requirements of section 586(7), a letter 
     issued pursuant to section 330.14(g) of title 21, Code of 
     Federal Regulations before the date of enactment of the 
     Sunscreen Innovation Act, with respect to a pending request, 
     shall be deemed to be a proposed sunscreen order and 
     displayed on the Internet website of the Food and Drug 
     Administration. Notification of the availability of such 
     letter shall be published in the Federal Register not later 
     than 45 calendar days after the date of enactment of such 
     Act.
       ``(4) Proposed sunscreen order.--In the case of a pending 
     request for which the Secretary has not issued a letter 
     pursuant to section 330.14(g) of title 21, Code of Federal 
     Regulations before the date of enactment of the Sunscreen 
     Innovation Act, the Secretary shall complete review of such 
     request and, not later than 90 calendar days after the date 
     of enactment of such Act, issue a proposed sunscreen order 
     with respect to such request.
       ``(5) Proposed sunscreen order by commissioner.--If the 
     Secretary does not issue a proposed sunscreen order under 
     paragraph (4), or the Secretary does not publish a 
     notification of the availability of a letter under paragraph 
     (3), as applicable, the sponsor of such request may notify 
     the Office of the Commissioner of such request and request 
     review by the Office of the Commissioner. The Commissioner 
     shall, not later than 60 calendar days after the date of 
     notification under this paragraph, issue a proposed order 
     with respect to such request.
       ``(6) Public comment period.--A proposed sunscreen order 
     issued under paragraph (4) or (5), or a notification of the 
     availability of a letter under paragraph (3), with respect to 
     a pending request shall provide for a period of 45 calendar 
     days for public comment.
       ``(7) Meeting.--A sponsor may request, in writing, a 
     meeting with respect to a proposed sunscreen order issued 
     under this subsection, including a letter deemed to be a 
     proposed sunscreen order under paragraph (3), not later than 
     30 calendar days after the Secretary issues such order or the 
     date upon which such feedback letter is deemed to be a 
     proposed sunscreen order, as applicable. The Secretary shall 
     convene a meeting with such sponsor not later than 45 
     calendar days after the date of such request for a meeting.
       ``(8) Advisory committee.--In the case of a proposed 
     sunscreen order under paragraph (3), (4), or (5), an Advisory 
     Committee meeting may be convened for the purpose of 
     reviewing and providing recommendations regarding the pending 
     request.
       ``(9) Final sunscreen order.--In the case of a proposed 
     sunscreen order under paragraph (3), (4), or (5)--
       ``(A) the Secretary shall issue a final sunscreen order 
     with respect to the request--
       ``(i) in the case of a proposed sunscreen order described 
     in subparagraph (A) or (B) of section 586(7), not later than 
     90 calendar days after the end of the public comment period 
     under paragraph (6); or
       ``(ii) in the case of a proposed sunscreen order described 
     in subparagraph (C) of section 586(7)--

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

       ``(B) if the Secretary does not issue such final sunscreen 
     order within such 90-, 210-, or 270-calendar-day period, as 
     applicable, the sponsor of such request may notify the Office 
     of the Commissioner about such request and request review by 
     the Office of the Commissioner.
       ``(10) Final sunscreen order by commissioner.--The 
     Commissioner shall issue a final sunscreen order with respect 
     to a proposed sunscreen order subject to paragraph (9)(B) not 
     later than 60 calendar days after the date of notification 
     under such paragraph.
       ``(c) Advisory Committee.--The Secretary shall not be 
     required to--
       ``(1) convene the Advisory Committee--
       ``(A) more than once with respect to any request under 
     section 586A or any pending request; or

[[Page 15000]]

       ``(B) more than twice in any calendar year with respect to 
     the review under this section; or
       ``(2) submit more than a total of 3 requests under section 
     586A or pending requests to the Advisory Committee per 
     meeting.
       ``(d) No Delegation.--Any responsibility vested in the 
     Commissioner by subsection (a)(2), (a)(6), (b)(5), or (b)(10) 
     shall not be delegated.
       ``(e) Effect of Final Sunscreen Order.--
       ``(1) In general.--
       ``(A) Sunscreen active ingredients determined to be 
     grase.--Upon issuance of a final sunscreen order determining 
     that a nonprescription sunscreen active ingredient or 
     combination of nonprescription sunscreen active ingredients 
     is GRASE and is not misbranded, a sunscreen containing such 
     ingredient or combination of ingredients shall be permitted 
     to be introduced or delivered into interstate commerce for 
     use under the conditions described in such final sunscreen 
     order, in accordance with all requirements applicable to 
     drugs not subject to section 503(b)(1), for so long as such 
     final sunscreen order remains in effect.
       ``(B) Sunscreen active ingredients determined not to be 
     grase.--Upon issuance of a final sunscreen order determining 
     that a nonprescription sunscreen active ingredient or 
     combination of nonprescription sunscreen active ingredients 
     is not GRASE and is misbranded, a sunscreen containing such 
     ingredient or combination of ingredients shall not be 
     introduced or delivered into interstate commerce, for use 
     under the conditions described in such final sunscreen order, 
     unless an application is approved pursuant to section 505 
     with respect to a sunscreen containing such ingredient or 
     combination of ingredients, or unless conditions are later 
     established under which such ingredient or combination of 
     ingredients is later determined to be GRASE and not 
     misbranded under the over-the-counter drug monograph system.
       ``(2) Amendments to final sunscreen orders.--
       ``(A) Amendments at initiative of secretary.--In the event 
     that information relevant to a nonprescription sunscreen 
     active ingredient or combination of nonprescription sunscreen 
     active ingredients becomes available to the Secretary after 
     issuance of a final sunscreen order, the Secretary may amend 
     such final sunscreen order by issuing a new proposed 
     sunscreen order under subsection (a)(1) and following the 
     procedures set forth in this section.
       ``(B) Petition to amend final order.--Any interested person 
     may petition the Secretary to amend a final sunscreen order 
     under section 10.30, title 21 Code of Federal Regulations (or 
     any successor regulations). If the Secretary grants any 
     petition under such section, the Secretary shall initiate the 
     process for amending a final sunscreen order by issuing a new 
     proposed sunscreen order under subsection (a)(1) and 
     following the procedures set forth in this section.
       ``(C) Applicability of final orders.--Once the Secretary 
     issues a new proposed sunscreen order to amend a final 
     sunscreen order under subparagraph (A) or (B), such final 
     sunscreen order shall remain in effect and paragraph (3) 
     shall not apply to such final sunscreen order until the 
     Secretary has issued a new final sunscreen order or has 
     determined not to amend the final sunscreen order.
       ``(3) Inclusion of ingredients that are subjects of final 
     orders in the sunscreen monograph.--
       ``(A) Amending regulations.--
       ``(i) Requirement.--At any time that the Secretary proposes 
     to amend part 352 of title 21, Code of Federal Regulations 
     (or any successor regulations) concerning nonprescription 
     sunscreen, including pursuant to section 586E, except as 
     provided in clause (iv), the Secretary shall include in such 
     part 352 (or any successor regulations) any nonprescription 
     sunscreen active ingredient or combination of nonprescription 
     sunscreen active ingredients that is the subject of an 
     effective final sunscreen order of the type described in 
     section 586(2)(A) and issued since the time that the 
     Secretary last amended such regulations. Such regulation 
     shall set forth conditions of use under which each such 
     ingredient or combination of ingredients is GRASE and not 
     misbranded. If these conditions differ from, or are in 
     addition to, those previously set forth in the applicable 
     final sunscreen order, the Secretary shall provide notice and 
     opportunity for comment on such conditions in the rulemaking, 
     and the applicable final sunscreen order shall continue in 
     effect until the effective date of a final regulation, as set 
     forth in clause (iii).
       ``(ii) Inclusion of orders.--In proposing to amend the 
     regulations as described in clause (i), the Secretary shall 
     include in the proposed regulations a list of final sunscreen 
     orders that shall cease to be effective on the effective date 
     of a resulting final regulation. Such list shall include all 
     final sunscreen orders of the type described in section 
     586(2)(A) that are in effect on the date that such 
     regulations are proposed, with the exception that such list 
     shall not include any final sunscreen orders that, on the 
     date that the regulations are proposed, the Secretary is in 
     the process of amending under paragraph (2).
       ``(iii) Orders no longer effective.--Any final sunscreen 
     order included by the Secretary in a list described in clause 
     (ii) and in a list included in resulting final regulations 
     shall cease to be effective on the date that such final 
     regulations including such order in such list become 
     effective.
       ``(iv) Ingredients not grase.--If, notwithstanding a final 
     sunscreen order stating that a nonprescription sunscreen 
     active ingredient or combination of nonprescription sunscreen 
     active ingredients is GRASE and is not misbranded if marketed 
     in accordance with such order, while amending the regulations 
     as described in clause (i), the Secretary concludes that such 
     ingredient or combination of ingredients is no longer GRASE 
     for use in nonprescription sunscreen, the Secretary shall, at 
     the discretion of the Secretary, either initiate the process 
     for amending the final sunscreen order set forth in paragraph 
     (2) of this subsection or include in a proposed regulation an 
     explanation and information supporting the determination of 
     the Secretary that such ingredient or combination of 
     ingredients is no longer GRASE for use in nonprescription 
     sunscreen.
       ``(B) Procedure for updating regulations.--After the 
     Secretary amends and finalizes the regulations under part 352 
     of title 21, Code of Federal Regulations under section 586E 
     and such regulations become effective, the Secretary may use 
     direct final rulemaking to include in such regulations any 
     nonprescription sunscreen active ingredients that are the 
     subject of effective final sunscreen orders.

     ``SEC. 586D. GUIDANCE; OTHER PROVISIONS.

       ``(a) Guidance.--
       ``(1) In general.--
       ``(A) Draft guidance.--Not later than 1 year after the date 
     of enactment of the Sunscreen Innovation Act, the Secretary 
     shall issue draft guidance on the implementation of, and 
     compliance with, the requirements with respect to sunscreen 
     under this subchapter, including guidance on--
       ``(i) the format and content of information submitted by a 
     sponsor in support of a request under section 586A or a 
     pending request;
       ``(ii) the data required to meet the safety and efficacy 
     standard for determining whether a nonprescription sunscreen 
     active ingredient or combination of nonprescription sunscreen 
     active ingredients is GRASE and is not misbranded;
       ``(iii) the process by which a request under section 586A 
     or a pending request is withdrawn; and
       ``(iv) the process by which the Secretary will carry out 
     section 586C(c), including with respect to how the Secretary 
     will address the total number of requests received under 
     section 586A and pending requests.
       ``(B) Final guidance.--The Secretary shall finalize the 
     guidance described in subparagraph (A) not later than 2 years 
     after the date of enactment of the Sunscreen Innovation Act.
       ``(C) Inapplicability of paperwork reduction act.--Chapter 
     35 of title 44, United States Code shall not apply to 
     collections of information made for purposes of guidance 
     under this subsection.
       ``(2) Submissions pending issuance of final guidance.--
     Irrespective of whether final guidance under paragraph (1) 
     has been issued--
       ``(A) persons may, beginning on the date of enactment of 
     the Sunscreen Innovation Act, make submissions under this 
     subchapter; and
       ``(B) the Secretary shall review and act upon such 
     submissions in accordance with this subchapter.
       ``(b) Rules of Construction.--
       ``(1) Currently marketed sunscreens.--Nothing in this 
     subchapter shall be construed to affect the marketing of 
     sunscreens that are marketed in interstate commerce on or 
     before the date of enactment of this subchapter, except as 
     otherwise provided in this subchapter.
       ``(2) Ensuring safety and effectiveness.--Nothing in this 
     subchapter shall be construed to alter the authority of the 
     Secretary with respect to prohibiting the marketing of a 
     sunscreen that is not safe and effective or is misbranded, or 
     with respect to imposing restrictions on the marketing of a 
     sunscreen to ensure safety and effectiveness, except as 
     otherwise provided in this subchapter, including section 
     586C(e).
       ``(3) Other drugs.--Except as otherwise provided in section 
     586F, nothing in this subchapter shall be construed to affect 
     the authority of the Secretary under this Act or the Public 
     Health Service Act (42 U.S.C. 201 et seq.) with respect to a 
     drug other than a nonprescription sunscreen.
       ``(4) Effect on drugs otherwise approved.--Nothing in this 
     subchapter shall affect the marketing of a drug approved 
     under section 505 of this Act or section 351 of the Public 
     Health Service Act.
       ``(c) Timelines.--The timelines for the processes and 
     procedures under paragraphs (1), (2), (5), and (6) of section 
     586C(a) shall not apply to any requests submitted to the 
     Secretary under section 586A after the date that is 6 years 
     after the date of enactment of the Sunscreen Innovation Act.

     ``SEC. 586E. SUNSCREEN MONOGRAPH.

       ``(a) In General.--Not later than 5 years after the date of 
     enactment of the Sunscreen Innovation Act, the Secretary 
     shall amend and finalize regulations under part 352 of title 
     21, Code of Federal Regulations concerning nonprescription 
     sunscreen that are effective not later than 5 years after 
     such date of enactment. The Secretary shall publish such 
     regulations not less than 30 calendar days before the 
     effective date of such regulations.
       ``(b) Reports.--If the regulations promulgated under 
     subsection (a) do not include provisions related to the 
     effectiveness of various sun protection factor levels, and do 
     not address all dosage forms known to the Secretary to be 
     used in sunscreens marketed in the United States without a 
     new drug approval under section 505, the Secretary shall 
     submit a report to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives on the rationale for 
     such provisions not

[[Page 15001]]

     being included in such regulations, and a plan and timeline 
     to compile any information necessary to address such 
     provisions through final regulations.''.
       (b) Rules of Construction.--Nothing in the amendment made 
     by this section shall be construed to--
       (1) limit the right of a sponsor (as defined in section 
     586(8) of the Federal Food, Drug, and Cosmetic Act, as added 
     by subsection (a)) to request that the Secretary of Health 
     and Human Services convene an advisory committee; or
       (2) limit the authority of the Secretary of Health and 
     Human Services to meet with a sponsor (as defined in section 
     586(8) of the Federal Food, Drug, and Cosmetic Act, as added 
     by subsection (a)).

     SEC. 3. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS.

       Subchapter I of chapter V of the Federal Food, Drug, and 
     Cosmetic Act, as added by section 2, is amended by adding at 
     the end the following:

     ``SEC. 586F. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS.

       ``(a) Pending Time and Extent Applications.--
       ``(1) In general.--
       ``(A) Request for framework for review.--If, prior to the 
     date of enactment of the Sunscreen Innovation Act, an 
     application was submitted pursuant to section 330.14 of title 
     21, Code of Federal Regulations for a GRASE determination for 
     a drug other than a nonprescription sunscreen active 
     ingredient or combination of nonprescription sunscreen active 
     ingredients and such drug was found to be eligible to be 
     considered for inclusion in the over-the-counter drug 
     monograph system pursuant to section 330.14 of title 21, Code 
     of Federal Regulations, the sponsor of such application may 
     request that the Secretary provide a framework under 
     paragraph (2) for the review of such application.
       ``(B) Request requirements.--A request for a framework for 
     review of an application made under subparagraph (A) shall be 
     made within 180 calendar days of the date of enactment of the 
     Sunscreen Innovation Act and shall include the preference of 
     such sponsor as to whether such application is reviewed by 
     the Secretary in accordance with--
       ``(i) the processes and procedures set forth for pending 
     requests under section 586C(b), except that specific 
     timelines shall be determined in accordance with other 
     applicable requirements under this section;
       ``(ii) the processes and procedures set forth under part 
     330 of title 21, Code of Federal Regulations (or any 
     successor regulations);
       ``(iii) an initial filing determination under the processes 
     and procedures described in section 586B(b) and the processes 
     and procedures set forth for pending requests under section 
     586C(b), except that specific timelines shall be determined 
     in accordance with other applicable requirements under this 
     section; or
       ``(iv) an initial filing determination under the processes 
     and procedures described in section 586B(b) and the processes 
     and procedures set forth under part 330 of title 21, Code of 
     Federal Regulations (or any successor regulations).
       ``(C) No request.--If a sponsor described in subparagraph 
     (A) does not make such request within 180 calendar days of 
     the date of enactment of the Sunscreen Innovation Act, such 
     application shall be reviewed by the Secretary in accordance 
     with the timelines of the applicable regulations when such 
     regulations are finalized under subsection (b).
       ``(2) Framework.--Not later than 1 year after the date of 
     enactment of the Sunscreen Innovation Act, the Secretary 
     shall provide, in writing, a framework to each sponsor that 
     submitted a request under paragraph (1). Such framework shall 
     set forth the various timelines, in calendar days, with 
     respect to the processes and procedures for review under 
     clauses (i), (ii), (iii), and (iv) of paragraph (1)(B) and--
       ``(A) such timelines shall account for the considerations 
     under paragraph (5); and
       ``(B) the timelines for the various processes and 
     procedures shall not be shorter than the timelines set forth 
     for pending requests under sections 586B(b) and 586C(b), as 
     applicable.
       ``(3) Governing processes and procedures for review.--
       ``(A) Election.--Not later than 60 calendar days after the 
     Secretary provides a framework to a sponsor under paragraph 
     (2), such sponsor may provide an election to the Secretary 
     regarding the processes and procedures for review under 
     clause (i), (ii), (iii), or (iv) of paragraph (1)(B). If such 
     sponsor makes such election, the Secretary shall review the 
     application that is the subject of such election pursuant to 
     the processes and procedures elected by such sponsor and the 
     applicable timelines in calendar days set forth under such 
     framework, which the Secretary shall confirm in writing to 
     the sponsor not later than the date upon which the Secretary 
     provides a report under paragraph (4). If such sponsor does 
     not make such election, such application shall be reviewed by 
     the Secretary in accordance with the timelines of the 
     applicable regulations when such regulations are finalized 
     under subsection (b).
       ``(B) Different processes and procedures.--At any time 
     during review of an application, the Secretary may review 
     such application under different processes and procedures 
     under clause (i), (ii), (iii), or (iv) of paragraph (1)(B) 
     than the processes and procedures the sponsor elected in 
     accordance with subparagraph (A), so long as the Secretary 
     proposes, in writing, the change and the sponsor agrees, in 
     writing, to such change.
       ``(C) Inclusion of ingredients in monographs.--If the 
     sponsor elects to use the processes and procedures for review 
     in accordance with clause (i) or (iii) of paragraph (1)(B), 
     the Secretary may incorporate any resulting final order into 
     a regulation addressing the conditions under which other 
     drugs in the same therapeutic category are GRASE and not 
     misbranded, including through direct final rulemaking, and 
     the final order so incorporated shall cease to be effective 
     on the effective date of the final regulation that addresses 
     such drug.
       ``(4) Letter regarding pending applications.--Not later 
     than 18 months after the date of enactment of the Sunscreen 
     Innovation Act, the Secretary shall report to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives, in writing, regarding all pending 
     applications subject to paragraph (1). In such letter, the 
     Secretary shall provide a report on the review of such 
     applications, including the timelines, in calendar days, for 
     the review and GRASE determination for each application. Such 
     timelines shall account for the considerations under 
     paragraph (5).
       ``(5) Timelines.--The timelines in calendar days 
     established by the Secretary pursuant to this subsection--
       ``(A) may vary based on the content, complexity, and format 
     of the application submitted to the Secretary; and
       ``(B) shall--
       ``(i) reflect the public health priorities of the Food and 
     Drug Administration, including the potential public health 
     benefits posed by the inclusion of additional drugs in the 
     over-the-counter drug monograph system;
       ``(ii) take into consideration the resources available to 
     the Secretary for carrying out such priorities and the 
     processes and procedures described in paragraphs (1)(B) and 
     (2); and
       ``(iii) be reasonable, taking into consideration the 
     requirements described in clauses (i) and (ii).
       ``(b) New Time and Extent Applications.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Sunscreen Innovation Act, the Secretary 
     shall issue proposed regulations establishing timelines for 
     the review of applications for GRASE determinations for drugs 
     other than nonprescription sunscreen active ingredients or 
     combinations of nonprescription sunscreen active ingredients 
     that are submitted to the Secretary after the date of 
     enactment of the Sunscreen Innovation Act, under section 
     330.14 of title 21, Code of Federal Regulations (or any 
     successor regulations), and that are found to be eligible to 
     be considered for inclusion in the over-the-counter drug 
     monograph system pursuant to section 330.14 of title 21, Code 
     of Federal Regulations (or any successor regulations), or 
     that are subject to this subsection pursuant to paragraph (1) 
     or (3) of subsection (a), as applicable, providing--
       ``(A) timely and efficient completion of evaluations of 
     applications under section 330.14 of title 21, Code of 
     Federal Regulations (or any successor regulations) for drugs 
     other than sunscreens; and
       ``(B) timely and efficient completion of the review of the 
     safety and effectiveness submissions pursuant to such 
     applications, including establishing--
       ``(i) reasonable timelines, in calendar days, for the 
     applicable proposed and final regulations for applications of 
     various content, complexity, and format, and timelines for 
     internal procedures related to such processes; and
       ``(ii) measurable metrics for tracking the extent to which 
     the timelines set forth in the regulations are met.
       ``(2) Timelines.--The timelines in calendar days 
     established in the regulations under paragraph (1)--
       ``(A) may vary based on the content, complexity, and format 
     of the application submitted to the Secretary; and
       ``(B) shall--
       ``(i) reflect the public health priorities of the Food and 
     Drug Administration, including the potential public health 
     benefits posed by the inclusion of additional drugs in the 
     over-the-counter drug monograph system;
       ``(ii) take into consideration the resources available to 
     the Secretary for carrying out such priorities and the 
     processes and procedures described in paragraph (1); and
       ``(iii) be reasonable, taking into consideration the 
     requirements described in clauses (i) and (ii).
       ``(3) Procedure.--In promulgating regulations under this 
     subsection, the Secretary shall issue a notice of proposed 
     rulemaking that includes a copy of the proposed regulation, 
     provide a period of not less than 60 calendar days for 
     comments on the proposed regulation, and publish the final 
     regulation not less than 30 calendar days before the 
     effective date of the regulation.
       ``(4) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     this section only as described in paragraphs (1), (2), and 
     (3).
       ``(5) Final regulations.--The Secretary shall finalize the 
     regulations under this section not later than 27 months after 
     the date of enactment of the Sunscreen Innovation Act.''.

     SEC. 4. REPORTS.

       (a) Initial GAO Report.--Not later than 3 years after the 
     date of enactment of this Act, the Comptroller General of the 
     United States shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report reviewing the

[[Page 15002]]

     overall progress of the Secretary of Health and Human 
     Services in carrying out subchapter I of chapter V of the 
     Federal Food, Drug, and Cosmetic Act (as added by section 2 
     and amended by section 3 and subsection (c)), including 
     findings on and recommendations with respect to--
       (1) the progress made in completing the review of requests 
     under subchapter I of chapter V of the Federal Food, Drug, 
     and Cosmetic Act, including pending requests, and the 
     feasibility of the timelines associated with such subchapter;
       (2) the role of the Office of the Commissioner of Food and 
     Drugs in issuing determinations with respect to requests 
     reviewed under such subchapter, including the number of 
     requests transferred to the Office of the Commissioner under 
     section 586C of such Act;
       (3) the extent to which advisory committees were convened 
     by the Secretary regarding requests under subchapter I of 
     chapter V of the Federal Food, Drug, and Cosmetic Act, 
     including pending requests; and
       (4) the types of metrics that have been, or should be, 
     established for the review of time and extent applications.
       (b) Subsequent GAO Report.--Not later than 5\1/2\ years 
     after the date of enactment of this Act, the Comptroller 
     General of the United States shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report reviewing the overall progress of 
     the Secretary of Health and Human Services in carrying out 
     subchapter I of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (as added by section 2 and amended by section 3 
     and subsection (c)) and the regulation of over-the-counter 
     drug products, including findings on and recommendations with 
     respect to--
       (1) updates on the matters reported on by the Comptroller 
     General under subsection (a);
       (2) significant factors impacting the ability of the Food 
     and Drug Administration to fulfill the mission of the agency 
     with regard to the regulation of over-the-counter drug 
     products, including finalizing outstanding monographs and 
     responding to emerging and novel safety issues;
       (3) the performance of the Secretary in carrying out 
     section 586E of the Federal Food, Drug, and Cosmetic Act;
       (4) the types of metrics that have been, or should be, 
     established for the review and regulation of over-the-counter 
     drug products; and
       (5) timeliness, efficiency, and accountability in reviewing 
     time and extent applications and safety and effectiveness 
     reviews for over-the-counter drug products.
       (c) FDA Report.--Subchapter I of chapter V of the Federal 
     Food, Drug, and Cosmetic Act, as amended by section 3, is 
     further amended by adding at the end the following:

     ``SEC. 586G. REPORT.

       ``(a) In General.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of the Sunscreen Innovation Act, and on the 
     dates that are 2 and 4 years thereafter, the Secretary shall 
     issue a report to the Committee on Health, Education, Labor, 
     and Pensions of the Senate and the Committee on Energy and 
     Commerce of the House of Representatives describing actions 
     taken under this subchapter.
       ``(2) Contents.--The reports under this subsection shall 
     include--
       ``(A) a review of the progress made in issuing GRASE 
     determinations for pending requests, including the number of 
     pending requests--
       ``(i) reviewed and the decision times for each request, 
     measured from the date of the original request for an 
     eligibility determination submitted by the sponsor;
       ``(ii) resulting in a determination that the 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients is GRASE and is 
     not misbranded;
       ``(iii) resulting in a determination that the 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients is not GRASE and 
     is misbranded and the reasons for such determinations; and
       ``(iv) for which a determination has not been made, and an 
     explanation for the delay, a description of the current 
     status of each such request, and the length of time each such 
     request has been pending, measured from the date of original 
     request for an eligibility determination by the sponsor;
       ``(B) a review of the progress made in issuing GRASE 
     determinations for requests not included in the reporting 
     under subparagraph (A), including the number of such 
     requests--
       ``(i) reviewed and the decision times for each request;
       ``(ii) resulting in a determination that the 
     nonprescription sunscreen active ingredient, combination of 
     nonprescription sunscreen active ingredients, or other 
     ingredient is GRASE and is not misbranded;
       ``(iii) resulting in a determination that the 
     nonprescription sunscreen active ingredient, combination of 
     nonprescription sunscreen active ingredients, or other 
     ingredient is not GRASE and is misbranded and the reasons for 
     such determinations; and
       ``(iv) for which a determination has not been made, and an 
     explanation for the delay, a description of the current 
     status of each such request, and the length of time each such 
     request has been pending, measured from the date of original 
     request for an eligibility determination by the sponsor;
       ``(C) an annual accounting (including information from 
     years prior to the date of enactment of the Sunscreen 
     Innovation Act where such information is available) of the 
     total number of requests submitted, pending, or completed 
     under this subchapter, including whether such requests were 
     the subject of an advisory committee convened by the 
     Secretary;
       ``(D) a description of the staffing and resources relating 
     to the costs associated with the review and decisionmaking 
     pertaining to requests under this subchapter;
       ``(E) a review of the progress made in meeting the 
     deadlines with respect to processing requests under this 
     subchapter; and
       ``(F) to the extent the Secretary determines appropriate, 
     recommendations for process improvements in the handling of 
     requests under this subchapter, including the advisory 
     committee review process.
       ``(b) Method.--The Secretary shall publish the reports 
     under subsection (a) in the manner the Secretary determines 
     to be the most effective for efficiently disseminating the 
     report, including publication of the report on the Internet 
     website of the Food and Drug Administration.''.

  Mr. REID. I ask unanimous consent that the committee-reported 
substitute amendment be agreed to, the bill, as amended, be read a 
third time and passed, and the motion to reconsider be considered made 
and laid upon the table, with no intervening action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The committee-reported amendment in the nature of a substitute was 
agreed to.
  The bill (S. 2141), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.

                          ____________________