[Congressional Record (Bound Edition), Volume 160 (2014), Part 9]
[House]
[Pages 13316-13321]
[From the U.S. Government Publishing Office, www.gpo.gov]




                        SUNSCREEN INNOVATION ACT

  Mr. WHITFIELD. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 4250) 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, 
as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 4250

       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.

       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 Active Ingredients

     ``SEC. 586. DEFINITIONS.

       ``In this subchapter:
       ``(1) The term `Advisory Committee' means the 
     Nonprescription Drug Advisory Committee or any successor to 
     such Committee.
       ``(2) The terms `generally recognized as safe and 
     effective' and `GRASE' mean 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 product's labeling, as 
     described in section 201(p).
       ``(3) The term `GRASE determination' means, with respect to 
     a nonprescription sunscreen active ingredient or a 
     combination of nonprescription sunscreen active ingredients, 
     a determination of whether such ingredients or combination of 
     ingredients is generally recognized as safe and effective and 
     not misbranded for use under the conditions prescribed, 
     recommended, or suggested in the product's labeling, as 
     described in section 201(p).
       ``(4) The term `nonprescription' means not subject to 
     section 503(b)(1).
       ``(5) The term `pending request' means each request 
     submitted to the Secretary--
       ``(A) for consideration for inclusion in the over-the-
     counter drug monograph system;
       ``(B) that was deemed eligible for such review by 
     publication of a notice of eligibility in the Federal 
     Register prior to the date of enactment of the Sunscreen 
     Innovation Act; and
       ``(C) for which safety and effectiveness data has been 
     submitted to the Secretary prior to such date of enactment.
       ``(6) The term `sponsor' means the person submitting the 
     request under section 586A(a), including a time and extent 
     application under section 586B, or the person that submitted 
     the pending request.
       ``(7) 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 radiation.
       ``(8) The term `sunscreen' means a product containing one 
     or more sunscreen active ingredients.

     ``SEC. 586A. GENERAL PROVISIONS.

       ``(a) 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 generally 
     recognized as safe and effective and not misbranded.
       ``(b) Rules of Construction.--
       ``(1) Currently marketed sunscreens.--Nothing in this 
     subchapter shall be construed to affect the marketing of 
     sunscreens that are lawfully marketed in the United States on 
     or before the date of enactment of this subchapter.
       ``(2) Ensuring safety and effectiveness.--Nothing in this 
     subchapter shall be construed to alter the Secretary's 
     authority to prohibit the marketing of a sunscreen that is 
     not safe and effective or to impose restrictions on the 
     marketing of a sunscreen to ensure safety and effectiveness.
       ``(3) Other products.--Nothing in this subchapter shall be 
     construed to affect the Secretary's regulation of products 
     other than sunscreens.
       ``(c) Sunset.--This subchapter shall cease to be effective 
     at the end of the 5-year period beginning on the date of 
     enactment of this subchapter.

     ``SEC. 586B. ELIGIBILITY DETERMINATION.

       ``(a) In General.--Upon receipt of a request under section 
     586A(a), not later than 60 days after the date of receipt of 
     such request, the Secretary shall--
       ``(1) determine whether the request is eligible for further 
     review under sections 586C and 586D, as described in 
     subsection (b);
       ``(2) notify the sponsor of the Secretary's determination; 
     and
       ``(3) make such determination publicly available in 
     accordance with subsection (c).
       ``(b) Criteria for Eligibility.--
       ``(1) In general.--To be eligible for review under sections 
     586C and 586D, 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--
       ``(A) is not included in the stayed sunscreen monograph in 
     part 352 of title 21, Code of Federal Regulations; and
       ``(B) has been used to a material extent and for a material 
     time, as described in section 201(p)(2).
       ``(2) Time and extent application.--A sponsor shall include 
     in a request under section 586A(a) a time and extent 
     application including all the information required to meet 
     the standard described in paragraph (1)(B).
       ``(c) Public Availability.--
       ``(1) Redactions for confidential information.--If a 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients is determined to 
     be eligible for further review under subsection (a)(1), 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.
       ``(2) Identification of confidential information by 
     sponsor.--Sponsors shall identify any information which the 
     sponsor considers to be confidential information described in 
     paragraph (1).
       ``(3) Confidentiality during eligibility review.--The 
     information contained in a request under section 586A(a) 
     shall remain confidential during the Secretary's 
     consideration under this section of whether the request is 
     eligible for further review.

     ``SEC. 586C. DATA SUBMISSION; FILING DETERMINATION.

       ``(a) In General.--In the case of a request under section 
     586A(a) that is determined to be eligible under section 586B 
     for further review under this section and section 586D--

[[Page 13317]]

       ``(1) the Secretary shall, in notifying the public under 
     section 586B(a)(3) of such eligibility determination, invite 
     the sponsor of the request and any other interested party to 
     submit, in support of or otherwise relating to a GRASE 
     determination--
       ``(A) published and unpublished data and other information 
     related to the safety and effectiveness of the 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients for its intended 
     nonprescription uses; or
       ``(B) any other comments; and
       ``(2) not later than 60 days after the submission of such 
     data and other information by the sponsor, including any 
     revised submission of such data and other information 
     following a refusal to file under subparagraph (B), the 
     Secretary shall--
       ``(A)(i) issue a written notification to the sponsor 
     determining that the request under section 586A(a), together 
     with such data and other information, is sufficiently 
     complete to conduct a substantive review and make such 
     notification publicly available; and
       ``(ii) file such request; or
       ``(B) issue a written notification to the sponsor refusing 
     to file the request and stating the reasons for the refusal 
     and why the data and other information submitted is not 
     sufficiently complete to conduct a substantive review and 
     make such notification publicly available;
       ``(3) the Secretary shall, in filing a request under 
     paragraph (2)--
       ``(A) invite the public to submit further comments with 
     respect to such filing; and
       ``(B) limit such public comment, and the comment period 
     under paragraph (1), to the period ending on the date that is 
     60 days after such filing;
       ``(4) if the Secretary refuses to file the request--
       ``(A) the sponsor may, within 30 days of receipt of written 
     notification of such refusal, seek a meeting with the 
     Secretary regarding whether the Secretary should file the 
     request; and
       ``(B) the Secretary shall convene the meeting; and
       ``(5) following any such meeting--
       ``(A) if the sponsor asks that the Secretary file the 
     request (with or without amendments to correct any purported 
     deficiencies to the request) the Secretary shall file the 
     request over protest, issue a written notification of the 
     filing to the sponsor, and make such notification publicly 
     available; and
       ``(B) if the request is so filed over protest, the 
     Secretary shall not require the sponsor to resubmit a copy of 
     the request for purposes of such filing.
       ``(b) Reasons for Refusal to File Request.--The Secretary 
     may refuse to file a request submitted under section 586A(a) 
     if the Secretary determines the data or other information 
     submitted by the sponsor under this section are not 
     sufficiently complete to conduct a substantive review with 
     respect to such request.
       ``(c) Public Availability.--
       ``(1) Redactions for confidential information.--The 
     Secretary shall make data and other information submitted in 
     connection with a request under section 586A(a) 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.
       ``(2) Identification of confidential information by 
     sponsor.--Sponsors or any other individual submitting data or 
     other information under this section shall identify any 
     information which the sponsor or individual considers to be 
     confidential information described in paragraph (1).

     ``SEC. 586D. GRASE DETERMINATION.

       ``(a) Review of New Request.--
       ``(1) Proposed order by cder.--In the case of a request 
     under section 586A(a), the Director of the Center for Drug 
     Evaluation and Research shall--
       ``(A) not later than 300 days after the date on which the 
     request is filed under section 586C(a), complete the review 
     of the request and issue a proposed order determining that--
       ``(i) the nonprescription sunscreen active ingredient or 
     combination of nonprescription sunscreen active ingredients 
     that is the subject of the request--

       ``(I) is GRASE; and
       ``(II) is not misbranded;

       ``(ii) the nonprescription sunscreen active ingredient or 
     combination of nonprescription sunscreen active ingredients 
     that is the subject of the request--

       ``(I) is not GRASE; or
       ``(II) is misbranded; or

       ``(iii) additional information is necessary to allow the 
     Director of the Center for Drug Evaluation and Research to 
     complete the review of such request;
       ``(B) within such 300-day period, convene a meeting of the 
     Advisory Committee to review the request under section 
     586A(a): and
       ``(C) if the Director fails to issue such proposed order 
     within the 300-day period referred to in subparagraph (A), 
     transmit the request to the Commissioner of Food and Drugs 
     for review.
       ``(2) Proposed order by commissioner.--With respect to a 
     request transmitted to the Commissioner of Food and Drugs 
     under paragraph (1)(C), the Commissioner shall, not later 
     than 60 days after the date of such transmission, issue--
       ``(A) a proposed order described in paragraph (1)(A)(i);
       ``(B) a proposed order described in paragraph (1)(A)(ii); 
     or
       ``(C) a proposed order described in paragraph (1)(A)(iii).
       ``(3) Publication in federal register; public comment 
     period.--A proposed order issued under paragraph (1) or (2) 
     with respect to a request shall--
       ``(A) be published in the Federal Register; and
       ``(B) solicit public comments for a period of not more than 
     45 days.
       ``(4) Final order by cder.--In the case of a proposed order 
     under paragraph (1)(A) or (2) with respect to a request, the 
     Director of the Center for Drug Evaluation and Research 
     shall--
       ``(A) issue a final order with respect to the request--
       ``(i) in the case of a proposed order under clause (i) or 
     (ii) of paragraph (1)(A) or subparagraph (A) or (B) of 
     paragraph (2), not later than 90 days after the end of the 
     public comment period under paragraph (3)(B); or
       ``(ii) in the case of a proposed order under paragraph 
     (1)(A)(iii) or paragraph (2)(C), not later than 210 days 
     after the date on which the sponsor submits the additional 
     information requested pursuant to such proposed order; or
       ``(B) if the Director fails to issue such final order 
     within such 90- or 210-day period, as applicable, transmit 
     such proposed order to the Commissioner of Food and Drugs for 
     review.
       ``(5) Final order by commissioner.--With respect to a 
     proposed order transmitted to the Commissioner of Food and 
     Drugs under paragraph (4)(B), the Commissioner shall issue a 
     final order with respect to such proposed order not later 
     than 60 days after the date of such transmission.
       ``(b) Review of Pending Requests.--
       ``(1) In general.--The review of a pending request shall be 
     carried out by the Director of the Center for Drug Evaluation 
     and Research in accordance with paragraph (3).
       ``(2) Inapplicability of certain provisions.--Sections 586B 
     and 586C shall not apply with respect to any pending request.
       ``(3) Proposed order by cder.--The Director of the Center 
     for Drug Evaluation and Research shall--
       ``(A) within the timeframe applicable under paragraph (4), 
     complete the review of the request and issue a proposed order 
     determining that--
       ``(i) the nonprescription sunscreen active ingredient or 
     combination of nonprescription sunscreen active ingredients 
     that is the subject of the pending request--

       ``(I) is GRASE; and
       ``(II) is not misbranded;

       ``(ii) the nonprescription sunscreen active ingredient or 
     combination of nonprescription sunscreen active ingredients 
     that is the subject of the pending request--

       ``(I) is not GRASE; or
       ``(II) is misbranded; or

       ``(iii) additional information is necessary to allow the 
     Director of the Center for Drug Evaluation and Research to 
     complete the review of the pending request; and
       ``(B) if the Director fails to issue such proposed order 
     within the timeframe applicable under paragraph (4), transmit 
     the pending request to the Commissioner of Food and Drugs for 
     review.
       ``(4) Timeframe for issuance of proposed order by cder.--
     The Director of the Center for Drug Evaluation and Research 
     shall issue a proposed order, as required by paragraph 
     (3)(A)--
       ``(A) in the case of a pending request for which the Food 
     and Drug Administration has issued a feedback letter before 
     the date of enactment of the Sunscreen Innovation Act, not 
     later than 45 days after such date of enactment; and
       ``(B) in the case of a pending request for which the Food 
     and Drug Administration has not issued a feedback letter 
     before the date of enactment of the Sunscreen Innovation Act, 
     not later than 90 days after such date of enactment.
       ``(5) Proposed order by commissioner.--With respect to a 
     pending request transmitted to the Commissioner of Food and 
     Drugs under paragraph (3)(B), the Commissioner shall, not 
     later than 60 days after the date of such transmission, 
     issue--
       ``(A) a proposed order described in paragraph (3)(A)(i);
       ``(B) a proposed order described in paragraph (3)(A)(ii); 
     or
       ``(C) a proposed order described in paragraph (3)(A)(iii).
       ``(6) Publication in federal register; public comment 
     period.--A proposed order issued under paragraph (3) or (5) 
     with respect to a pending request shall--
       ``(A) be published in the Federal Register; and
       ``(B) solicit public comments for a period of not more than 
     45 days.
       ``(7) Advisory committee.--For a proposed order issued 
     under paragraph (3)(A)(iii) or (5)(C) requesting additional 
     information, an Advisory Committee meeting shall be convened 
     if the sponsor requests, or the Director of the Center for 
     Drug Evaluation and Research or the Commissioner of Food and 
     Drugs decides, to convene such a meeting for the purpose of 
     reviewing the pending request.
       ``(8) Final order by cder.--In the case of a proposed order 
     under paragraph (3)(A) or (5) with respect to a request, the 
     Director of the Center for Drug Evaluation and Research 
     shall--
       ``(A) issue a final order with respect to the request--
       ``(i) in the case of a proposed order under clause (i) or 
     (ii) of paragraph (3)(A) or subparagraph (A) or (B) of 
     paragraph (5), not later than 90 days after the end of the 
     public comment period under paragraph (3)(B); or
       ``(ii) in the case of a proposed order under paragraph 
     (3)(A)(iii) or paragraph (5)(C)--

[[Page 13318]]

       ``(I) if the Advisory Committee is not convened pursuant to 
     paragraph (7), not later than 210 days after the date on 
     which the sponsor submits the additional information 
     requested pursuant to such proposed order; or
       ``(II) if the Advisory Committee is convened pursuant to 
     paragraph (7), not later than 270 days after date on which 
     the sponsor submits such additional information; or

       ``(B) if the Director fails to issue such final order 
     within such 90-, 210-, and 270-day period, as applicable, 
     transmit such proposed order to the Commissioner of Food and 
     Drugs for review.
       ``(9) Final order by commissioner.--With respect to a 
     proposed order transmitted to the Commissioner of Food and 
     Drugs under paragraph (8)(B), the Commissioner shall issue a 
     final order with respect to such proposed order not later 
     than 60 days after the date of such transmission.
       ``(c) Advisory Committee.--
       ``(1) Limitations.--The Food and Drug Administration--
       ``(A) shall not be required to convene the Advisory 
     Committee--
       ``(i) more than once with respect to any request under 
     section 586A(a) or any pending request; or
       ``(ii) more than twice in any twelve month period with 
     respect to the review of submissions under this section; and
       ``(B) shall not be required to submit more than 3 
     submissions to the Advisory Committee per meeting.
       ``(2) Membership.--In appointing the members of the 
     Advisory Committee, the Secretary may select to serve 
     temporarily as voting members on the Advisory Committee--
       ``(A) members of other Federal advisory committees; or
       ``(B) consultants from outside of the Department of Health 
     and Human Services who have substantive expertise regarding 
     sunscreen active ingredients.
       ``(d) No Delegation.--Any responsibility vested by this 
     section in the Commissioner of Food and Drugs is not 
     delegable.
       ``(e) Effect of Final Order.--
       ``(1) Content.--A final order under subsection (a)(4), 
     (a)(5), (b)(8), or (b)(9) with respect to a request under 
     section 586A(a) or a pending request shall determine that the 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients that is the 
     subject of the request--
       ``(A) is GRASE and is not misbranded; or
       ``(B) is not GRASE or is misbranded.
       ``(2) Active ingredients determined to be grase.--Upon 
     issuance of a final order determining that a nonprescription 
     sunscreen active ingredient or combination of nonprescription 
     sunscreen active ingredients is GRASE and is not misbranded, 
     the active ingredient or combination of active ingredients 
     shall be permitted to be introduced or delivered into 
     interstate commerce, for use under the conditions subject to 
     the final order, in accordance with all requirements 
     applicable to drugs not subject to section 503(b)(1).
       ``(3) Active ingredients determined not to be grase.--Upon 
     issuance of a final order determining that the 
     nonprescription sunscreen active ingredient or combination of 
     nonprescription sunscreen active ingredients is not GRASE or 
     is misbranded, the active ingredient or combination of active 
     ingredients shall not be introduced or delivered into 
     interstate commerce, for use under the conditions subject to 
     the final order, unless an application submitted pursuant to 
     section 505(b) with respect to such active ingredient or 
     combination of active ingredients is approved.

     ``SEC. 586E. REPORTS.

       ``(a) GAO Report.--Not later than 1 year after the date of 
     enactment of the Sunscreen Innovation Act, the Comptroller 
     General of the United States shall--
       ``(1) submit a report reviewing the overall progress of the 
     Secretary in carrying out this subchapter to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives; and
       ``(2) include findings on--
       ``(A) the progress made in completing the review of pending 
     requests; and
       ``(B) the role of the Office of the Commissioner of Food 
     and Drugs in issuing determinations with respect to pending 
     requests, including the number of requests transferred to the 
     Office of the Commissioner under section 586D.
       ``(b) Secretary's Report.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the Sunscreen Innovation Act, and every 2 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 
     section. Each report under this subsection shall be posted on 
     the Internet site of the Food and Drug Administration.
       ``(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 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, 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 in a timely 
     manner GRASE determinations for requests submitted under 
     section 586A(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 or combination of 
     nonprescription sunscreen active ingredients is GRASE and 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, 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) a description of the staffing and resources relating 
     to the costs associated with the review and decisionmaking 
     pertaining to requests under this subchapter;
       ``(D) a review of the progress made in meeting the 
     deadlines with respect to processing requests under this 
     subchapter;
       ``(E) to the extent the Secretary determines appropriate, 
     recommendations for process improvements in the handling of 
     pending and new requests, including the advisory committee 
     review process; and
       ``(F) recommendations for expanding the applicability of 
     this subchapter to nonprescription active ingredients that 
     are not related to the sunscreen category of over-the-counter 
     drugs.
       ``(c) Method.--The Secretary shall publish the reports 
     required under subsection (b) 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.''.

     SEC. 3. GUIDANCE.

       (a) In General.--
       (1) Issuance.--Not later than one year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs, 
     shall issue guidance, in accordance with good guidance 
     practices, on the implementation of, and compliance with, 
     subchapter I of chapter V of the Federal Food, Drug, and 
     Cosmetic Act, as added by section 2, including guidance on--
       (A) the criteria for determining whether a nonprescription 
     sunscreen active ingredient or combination of nonprescription 
     sunscreen active ingredients has been used to a material 
     extent and for a material time, as described in section 
     201(p)(2) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321(p)(2));
       (B) the format and content of a safety and effectiveness 
     data submission; and
       (C) the safety and efficacy standards for determining 
     whether a nonprescription sunscreen active ingredients or 
     combination of nonprescription sunscreen active ingredients 
     is generally recognized as safe and effective, as defined in 
     section 586 of such subchapter I.
       (2) 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.
       (b) Submissions Pending Issuance of Final Guidance.--
     Irrespective of whether final guidance under subsection (a) 
     has been issued--
       (1) persons may, beginning on the date of enactment of this 
     Act, make submissions under subchapter I of chapter V of the 
     Federal Food, Drug, and Cosmetic Act, as added by section 2; 
     and
       (2) the Secretary of Health and Human Services, acting 
     through the Commissioner of Food and Drugs, shall review and 
     act upon such submissions in accordance with such subchapter.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Kentucky (Mr. Whitfield) and the gentleman from Michigan (Mr. Dingell) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Kentucky.


                             General Leave

  Mr. WHITFIELD. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and insert extraneous materials on the bill into the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Kentucky?
  There was no objection.
  Mr. WHITFIELD. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in support of H.R. 4250, the Sunscreen 
Innovation Act, which seeks to address an important area of public 
concern by

[[Page 13319]]

strengthening the sunscreen ingredient review process at the Food and 
Drug Administration.
  I would like to remind everyone that skin cancer is the most 
prevalent kind of cancer in America. Each year, there are more new 
cases of skin cancer than breast, prostate, lung, and colon cancer 
combined. By 2015, it is estimated that one in 50 Americans will 
develop melanoma in their lifetime. Melanoma also happens to be one of 
the most common forms of cancer in young adults, particularly young 
women.
  Even though the Food and Drug Administration has listed action on 
sunscreen ingredient applications as a priority since 2008, no new 
sunscreen ingredients have been approved by the FDA. In fact, none have 
been approved in 15 years. This is despite the fact that eight 
sunscreen applications have been pending at the FDA, some as far back 
as 2002.
  I might add that we find ourselves in this predicament, even though 
in Europe and other places around the world, new sunscreen ingredients 
are being introduced into sunscreen products.
  This past April, the Energy and Commerce Committee held a hearing on 
the Sunscreen Innovation Act, where all of the expert witnesses, 
including the FDA, were in agreement that the current approval process 
is broken and in need of reform.
  So the objective of the Sunscreen Innovation Act is twofold: first, 
to expedite the review of pending applications at FDA; and, second, to 
create a timely and transparent process for new applications to be 
reviewed and acted on.
  The framework outlined in this legislation strikes an appropriate 
balance between consumer safety and access to the very best sunscreen 
product. The bill we have before us today reflects a bipartisan 
agreement reached in consultation with the Food and Drug Administration 
and outside stakeholders, such as the PASS Coalition and Environmental 
Working Group.
  I want to give a particular thanks to my colleague from Michigan (Mr. 
Dingell) for sponsoring this legislation with me. I would also like to 
thank Chairman Upton, who worked with us closely throughout the entire 
process, and Ranking Member Waxman for their assistance in reaching the 
agreement that allowed this legislation to come to the floor.
  I urge all my colleagues to support the bill. At this time, I reserve 
the balance of my time.
  Mr. DINGELL. I yield myself such time as I may consume.
  Mr. Speaker, I rise in support of H.R. 4250, the Sunscreen Innovation 
Act. This legislation proves that this body can work together, not only 
across the aisle but with the agencies under our jurisdiction and also 
with the industries concerned. This legislation has the support of 
everyone.

                              {time}  1745

  There is no opposition to it, and that includes the industry, it 
includes the health people, it also includes the environmentalists, and 
it includes the administration. UV rays from the Sun are, it is 
understood, increasing the amount of melanoma amongst our people 
enormously--800 percent amongst young women, and 400 percent amongst 
young men over the past 40 years.
  Sunscreens sold in the United States today do not offer the same 
level of protection as sunscreen sold in Europe, Canada, Australia, and 
other countries. In fact, the last over-the-counter sunscreen 
ingredient was approved by FDA in the 1990s. Some sunscreen ingredients 
have been waiting review by FDA for over a decade.
  This is inexcusable, and it should not be permitted because FDA has 
taken so long to review these applications. It is clear that increased 
accountability is needed at the agency to ensure these pending 
sunscreen applications are reviewed in a timely and speedy manner.
  I want to commend and congratulate my colleague, Mr. Whitfield, for 
his leadership and fine work on this, and also Chairman Upton for his 
outstanding work, and I want to congratulate my friends, Mr. Pallone 
and Mr. Waxman, for the good work which they have done on this 
legislation.
  Indeed, the staffs on both sides of the committee have been 
remarkable in what it is they have done on this matter, and it is 
interesting to note that we have the strong support of the American 
Academy of Dermatology, the American Cancer Society Cancer Action 
Network, the Melanoma Research Alliance, the Environmental Working 
Group, and the Melanoma Research Foundation.
  Mr. Speaker, I insert letters from those agencies into the Record.

                                   American Academy of Dermatology


                                                  Association,

                                    Washington, DC, July 21, 2014.
     Hon. Ed Whitfield,
     U.S. House of Representatives, Washington, DC.
     Hon. John Dingell,
     U.S. House of Representatives, Washington, DC.
       Dear Representative Whitfield and Representative Dingell:  
     The American Academy of Dermatology Association (Academy), 
     which represents more than 13,000 dermatologists nationwide, 
     commends you for working together to amend H.R. 4250, the 
     Sunscreen Innovation Act, which would ensure that sunscreen 
     ingredients are reviewed by the U.S. Food and Drug 
     Administration (FDA) within a predictable timeframe. The 
     Academy applauds you for your work with stakeholders on this 
     legislation and is pleased to offer its support for the 
     Committee-passed amended bill, which has the potential to 
     reduce Americans' risk for skin cancer by ensuring that they 
     have access to the safest, most effective sunscreens 
     available.
       Skin cancer is the most common cancer in the United States 
     and one in five Americans will develop skin cancer in their 
     lifetime. Dermatologists diagnose more than 3.5 million cases 
     and treat more than 2.2 million people with skin cancer every 
     year in the U.S. Research has shown that sunscreen helps 
     reduce the risk of skin cancer and is essential to protecting 
     the public from UV radiation. Proper use of sunscreen 
     combined with access to the safest, most effective 
     ingredients available will go a long way toward reducing 
     these statistics.
       We applaud you for working together to amend this 
     legislation, which will ensure that sunscreen ingredients are 
     thoroughly and expeditiously reviewed in a timely manner. We 
     support allowing the Nonprescription Drugs Advisory Committee 
     (NDAC) to provide recommendations on sunscreen ingredients to 
     the FDA, and are pleased to see a provision under the amended 
     bill that would allow the Secretary to appoint members of 
     other federal advisory committees or outside consultants with 
     substantive expertise regarding sunscreen active ingredients 
     to the NDAC when sunscreen ingredients are reviewed. We are 
     also in favor of the provisions within the amended 
     legislative language that strengthen Congressional oversight 
     by requiring reporting of FDA's activities and progress in 
     the review of sunscreen ingredients.
       We appreciate your continued leadership on this issue and 
     look forward to working with you in the fight against skin 
     cancer. If you have any questions or if we can provide any 
     additional information, please contact Christine O'Connor, 
     the Academy's Associate Director, Congressional Policy at 
     [email protected] or (202) 609-6330; or Niva Haynes, the 
     Academy's Manager, Congressional Policy at [email protected] or 
     (202) 712-2608.
           Sincerely,
                                      Brett M. Coldiron, MD, FAAD,
                                    President, American Academy of
     Dermatology Association.
                                  ____

                                           American Cancer Society


                                        Cancer Action Network,

                                      Washington, DC, May 6, 2014.
     Re Letter of support for legislation to improve the FDA 
         process for approving new sunscreen ingredients

     Hon. Jack Reed,
     U.S. Senate, Washington, DC.
     Hon. Ed Whitfield,
     U.S. House of Representatives, Washington, DC.
     Hon. Johnny Isakson,
     U.S. Senate, Washington, DC.
     Hon. John Dingell,
     U.S. House of Representatives, Washington, DC.
       Dear Senator Reed, Senator Isakson, Representative 
     Whitfield and Representative Dingell, On behalf of the 
     American Cancer Society Cancer Action Network (ACS CAN), I am 
     writing to express my support for legislation to reform the 
     current Food and Drug Administration sunscreen approval 
     process. ACS CAN is the nonprofit, nonpartisan advocacy 
     affiliate of the American Cancer Society.
       As you know, despite dramatic increases in rates of 
     melanoma and skin cancer, the last time the FDA approved a 
     new sunscreen ingredient was during the 1990's. H.R. 4250, 
     now pending in the House Energy and Commerce Committee, 
     provides a solid basis for coming to an agreement on a new 
     and workable FDA review process for approving new sunscreen 
     ingredients. Ultimately the goal is to provide Americans with 
     access to the most up-to-date, safe and effective sunscreen 
     technology now available in Europe while preserving FDA's 
     important authority to ensure the safety of over the counter 
     products like sunscreen. The review process in place today 
     does not work.

[[Page 13320]]

       We believe that it is important for Americans to have 
     access to the latest sunscreen technology to help curb the 
     current skin cancer epidemic in the United States and that is 
     why ACS CAN has joined the Public Access to SunScreens (PASS) 
     Coalition. The PASS Coalition is a multi-stakeholder 
     coalition formed to advocate for a regulatory pathway to 
     market for new, safe and effective sunscreen ingredients. 
     Specifically, the purpose of the Coalition is to develop 
     reforms that guarantee a timely review by the Food & Drug 
     Administration (FDA) of pending Time and Extent Applications 
     (TEAs) for over-the-counter (OTC) sunscreen ingredients.
       ACS CAN would like to thank you for supporting H.R. 4250, 
     and we look forward to working with you to resolve any 
     concerns regarding the legislation so that Americans have 
     access to the most effective and safe sunscreens.
       If you should have any questions or concerns, please do not 
     hesitate to contact me. Thank you.
           Sincerely,

                                        Christopher W. Hansen,

                                President, American Cancer Society
     Cancer Action Network.
                                  ____



                                                         BASF,

                                                      May 5, 2014.
     Re Letter of Support for the Sunscreen Innovation Act (S. 
         2141/H.R. 4250)

     Hon. Jack Reed,
     U.S. Senate, Washington, DC.
     Hon. Johnny Isakson,
     U.S. Senate, Washington, DC.
     Hon. Ed Whitfield,
     U.S. House of Representatives, Washington, DC.
     Hon. John Dingell,
     U.S. House of Representatives, Washington, DC.
       Dear Senator Reed, Senator Isakson, Representative 
     Whitfield and Representative Dingell: On behalf of BASF 
     Corporation, I am writing to express support for the 
     Sunscreen Innovation Act (S. 2141 and H.R. 4250) and thank 
     you for your leadership on this important issue. BASF 
     Corporation is the North American affiliate of BASF SE. Our 
     portfolio includes chemicals, plastics, crop protection 
     products and performance products. Through science and 
     innovation, we enable our customers in nearly every industry 
     to meet the current and future needs of society. We sum up 
     this contribution in our corporate purpose: We create 
     chemistry for a sustainable future.
       Among the products in BASF's portfolio are sunscreen 
     filters. BASF is a leading innovator and manufacturer of 
     sunscreen filters. We currently have three applications for 
     sunscreen filters pending at the Food and Drug Administration 
     (FDA)--including one since 2002. These ingredients have been 
     available to consumers globally since the 1990s. Moreover, 
     there are additional sunscreen filters we would like to 
     submit for FDA approval. Given the amount of time the current 
     applications have been pending, you can understand why it is 
     important that the current process for consideration of new 
     sunscreen ingredients needs to be improved.
       BASF Corporation supports the Sunscreen Innovation Act 
     because it creates a transparent and predictable review 
     process of new sunscreen ingredients and guarantees a 
     decision by FDA on applications for new ingredients within a 
     defined timeframe. We believe Americans should have access to 
     the latest sunscreen technology to help curb the current skin 
     cancer epidemic in the United States. This is why we joined 
     the Public Access to SunScreens (PASS) Coalition, a multi-
     stakeholder coalition formed to advocate for a regulatory 
     pathway to market for new, safe and effective sunscreen 
     ingredients.
       We look forward to working with you to enact this 
     legislation as expeditiously as possible.
           Sincerely,
                                               Steven J. Goldberg,
     Vice President and Associate General Counsel, Regulatory and 
     Government Affairs, BASF Corporation.
                                  ____



                                   Melanoma Research Alliance,

                                      Washington, DC, May 2, 2014.
     Re Letter of Support for H.R. 4250, the Sunscreen Innovation 
         Act


     Hon. Jack Reed,
     U.S. Senate, Washington, DC.
     Hon. Ed Whitfield,
     U.S. House of Representatives, Washington, DC.
     Hon. Johnny Isakson,
     U.S. Senate, Washington, DC.
     Hon. John Dingell,
     U.S. House of Representatives, Washington, DC.
       Dear Senator Reed, Senator Isakson, Representative 
     Whitfield and Representative Dingell: On behalf of the 
     Melanoma Research Alliance (MRA), I am writing to convey 
     MRA's support for the Sunscreen Innovation Act (5. 2141 and 
     H.R. 4250). MRA supports the Sunscreen Innovation Act because 
     it will reform the current sunscreen approval process and 
     encourages Congress to enact this critical legislation as 
     soon as possible.
       As you know, despite dramatic increases in rates of 
     melanoma and skin cancer, the last time the FDA approved a 
     new sunscreen ingredient is the 1990s. The Sunscreen 
     Innovation Act will provide Americans access to the latest 
     sunscreen technology, which addresses America's growing skin 
     cancer epidemic and fosters innovation in sunscreen. Its 
     provisions create a transparent and predictable review 
     process and guarantees that safe and effective products reach 
     consumers within a defined timeframe.
       MRA is a public charity that accelerates the pace of 
     scientific discovery and its translation in order to 
     eliminate suffering and death due to melanoma by funding 
     innovative research programs to improve melanoma prevention, 
     diagnosis, staging, and treatment. In addition, MRA works 
     with allies in government, non-profit, and industry to 
     promote awareness about melanoma among the public.
       As you know, in the U.S., one person dies every hour from 
     melanoma and the numbers of skin cancer cases have risen 
     dramatically. Sadly, many skin cancers could be prevented 
     simply by reducing exposure to UV radiation, the leading 
     environmental factor in the development of skin cancer.
       We believe that it is important for Americans to have 
     access to the latest sunscreen technology to help curb the 
     current skin cancer epidemic in the United States and that is 
     why we joined the Public Access to SunScreens (PASS) 
     Coalition. The PASS Coalition is a multi-stakeholder 
     coalition formed to advocate for a regulatory pathway to 
     market for new, safe and effective sunscreen ingredients. 
     Specifically, the purpose of the Coalition is to develop 
     reforms that guarantee a timely review by the Food & Drug 
     Administration (FDA) of pending Time and Extent Applications 
     (TEAs) for over-the-counter (OTC) sunscreen ingredients.
       There is unprecedented opportunity to make a difference in 
     the future course of melanoma and other skin cancers. We are 
     especially grateful for your leadership in the fight against 
     melanoma. Despite recent progress in the field, much more 
     needs to be done until melanoma prevention is effectively 
     addressed.
       MRA would like to thank you for introducing the Sunscreen 
     Innovation Act. We look forward to working with you to enact 
     this legislation this summer.
       If you should have any questions or concerns, please do not 
     hesitate to contact me. Thank you.
           Sincerely,
                                                 Wendy K.D. Selig,
     MRA President and Chief Executive Officer.
                                  ____



                                 Melanoma Research Foundation,

                                   Washington, DC, April 29, 2014.
     Re Letter of Support for H.R. 4250, the Sunscreen Innovation 
         Act

       Dear Senator Reed, Senator Isakson, Representative 
     Whitfield and Representative Dingell: On behalf of The 
     Melanoma Research Foundation (MRF) I am writing to express my 
     support for the Sunscreen Innovation Act (S. 2141 and H.R. 
     4250). The MRF supports the Sunscreen Innovation Act because 
     it will reform the current sunscreen approval process and 
     encourages Congress to enact this critical legislation as 
     soon as possible.
       As you know, despite dramatic increases in rates of 
     melanoma and skin cancer, the last time the FDA approved a 
     new sunscreen ingredient is the 1990s. The Sunscreen 
     Innovation Act will provide Americans access to the latest 
     sunscreen technology, which addresses America's growing skin 
     cancer epidemic and fosters innovation in sunscreen. Its 
     provisions create a transparent and predictable review 
     process and guarantees that safe and effective products reach 
     consumers within a defined timeframe.
       The Melanoma Research Foundation (MRF) is the largest 
     independent organization devoted to melanoma. The MRF is a 
     501(c) (3) nonprofit organization. Committed to the support 
     of medical research in finding effective treatments and 
     eventually a cure for melanoma, the MRF also educates 
     patients, caregivers and physicians about the prevention, 
     diagnosis and treatment of melanoma.
       Just one blistering sunburn at an early age can double a 
     person's chance of developing melanoma. Regular use of 
     sunscreen can greatly reduce the risk. The FDA's inaction 
     over the past 12 years has prevented consumers from having 
     access to new sunscreen products that could potentially save 
     their lives.
       We believe that it is important for Americans to have 
     access to the latest sunscreen technology to help curb the 
     current skin cancer epidemic in the United States and that is 
     why we joined the Public Access to SunScreens (PASS) 
     Coalition. The PASS Coalition is a multi-stakeholder 
     coalition formed to advocate for a regulatory pathway to 
     market for new, safe and effective sunscreen ingredients. 
     Specifically, the purpose of the Coalition is to develop 
     reforms that guarantee a timely review by the Food & Drug 
     Administration (FDA) of pending Time and Extent Applications 
     (TEAs) for over-the-counter (OTC) sunscreen ingredients.
       The MRF would you like to thank you for introducing the 
     Sunscreen Innovation Act. We look forward to working with you 
     to enact this legislation this summer.
       If you should have any questions or concerns, please do not 
     hesitate to contact me. Thank you.
           Sincerely,
     Mary Antonucci,

[[Page 13321]]

       National Director of Advocacy and Volunteer Services, The 
     Melanoma Research Foundation.

  Mr. DINGELL. I would like to observe that the staff has performed 
extraordinary work on this matter. I want to congratulate and thank 
Greg Sunstrum on my staff, as well as Taylor Booth, John Stone, Carly 
McWilliams, and Eric Flamm for their hard work on the legislation, and 
I want to recognize members of the PASS Coalition for their hard work 
and advocacy on behalf of this important issue.
  Mr. Speaker, I reserve the balance of my time.
  Mr. WHITFIELD. Mr. Speaker, at this time, I would like to yield 5 
minutes to my colleague from Michigan (Mr. Upton), the chairman of the 
Energy and Commerce Committee.
  Mr. UPTON. Mr. Speaker, I rise today in support of this very 
important bipartisan legislation to indeed help protect the public 
health. H.R. 4250, the Sunscreen Innovation Act, is just that.
  The growing rate of skin cancer in the U.S., including melanoma, is 
indeed alarming. According to the American Cancer Society, more 
Americans are diagnosed with skin cancer every year than breast, 
prostate, lung, and colon cancer combined, and in 2015, this year, one 
in every 50 of our constituents is going to be diagnosed with melanoma. 
We have got to take every step that we can to combat this public health 
crisis.
  Sadly, advancements in sunscreen have failed to keep pace with the 
increased awareness of the harm overexposure to the Sun can cause. The 
FDA has not approved a new nonprescription sunscreen ingredient for 
nearly 20 years, despite the fact that several applications have been 
pending at the agency for products that have been used safely and 
effectively in Europe and other parts of the world.
  The review process that these products have to go through at the FDA 
is, quite simply, broken. It needs to be fixed, and that is what this 
legislation does.
  I particularly want to commend the work that my good friend from the 
great State of Michigan (Mr. Dingell) and Mr. Whitfield and members of 
our entire committee, as this bill passed with unanimous support as we 
moved through the process. We wanted to come up with a solution to 
allow the FDA to fix the problem, and that is what this bill does.
  The Sunscreen Innovation Act is going to address the current backlog 
of applications pending at the FDA, as well as establish a predictable 
and transparent review process for new applications, incorporating 
meaningful input from experts and the public.
  The bill also establishes the number of timeframes for decisionmaking 
at the FDA and remove administrative hurdles identified by the FDA to 
the sunscreen approval process. More importantly, it is going to allow 
Americans to benefit from these products sooner, while ensuring that 
they are indeed safe and effective.
  We have had great success in our Energy and Commerce Committee this 
Congress, with over a dozen public health bills that have already been 
signed into law, obviously all bipartisan, and I am confident that this 
commonsense bill which received, again, unanimous support at our 
committee will soon be part of our strong record of results.
  In fact, I am told that this is the 61st bill that our committee has 
reported out that will be approved on the House floor. That is a pretty 
good record of achievement.
  This one really, like the others, has a real impact on all of our 
constituents. It gives the FDA the rightful tools, so that we can get 
to the bottom of the problem which impacts one in 50 Americans.
  So, again, I want to compliment Mr. Dingell, Mr. Whitfield, Mr. 
Pallone, Mr. Waxman, and others for helping deliver this bill to the 
House floor, and I look forward to a strong vote--hopefully voice--in a 
few minutes.
  Mr. DINGELL. Mr. Speaker, I have no further requests for time, so if 
the gentleman, my good friend, Mr. Whitfield, is ready, I am prepared 
to yield back with the strong urging to my colleagues to support this 
bill--which is strongly bipartisan--unanimously brought forward to the 
Congress and which has the strong support of both industry, government, 
and health groups.
  Mr. Speaker, I yield back the balance of my time.
  Mr. WHITFIELD. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I want to, once again, thank Mr. Dingell, and I 
appreciate his naming the staff because there was a lot of negotiations 
with FDA on this bill, and Taylor Booth on my staff and other members 
of the Energy and Commerce Committee staff, as named by Mr. Dingell, I 
want to give special thanks to them, and also, we appreciate the 
efforts of Mr. Pitts, who is the chairman of the Health Subcommittee.
  Without the help of him, Mr. Pallone, and their staffs, we would not 
have been able to bring this bill to the floor. So I would urge 
everyone to support it, and with that, I yield back the balance of my 
time.
  Ms. FRANKEL of Florida. Mr. Speaker, I rise today in support of H.R. 
4250, the Sunscreen Innovation Act. This legislation will support the 
important work of the Richard David Kann Melanoma Foundation of Palm 
Beach County, Florida.
  Melanoma is the deadliest form of skin cancer, killing one American 
every fifty minutes. Residents of Florida are especially vulnerable to 
the cancer-causing ultraviolet radiation from the sun. The Sunscreen 
Innovation Act will help Floridians protect themselves with the latest 
radiation-blocking sunscreen ingredients.
  I would like to thank the Richard David Kann Melanoma Foundation for 
their tireless work in preventing and detecting skin cancer, and I urge 
my colleagues to support this legislation.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Kentucky (Mr. Whitfield) that the House suspend the 
rules and pass the bill, H.R. 4250, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________