IB 

Union Calendar No. 418 

113TH CONGRESS 

2D SESSION H. R. 4250 

[Report No. 113–558] 

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. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 13, 2014 

Mr. WHITFIELD (for himself and Mr. DINGELL) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

JULY 24, 2014 

Additional sponsors: Mr. FARR, Mr. GUTHRIE, Mr. TIBERI, Mr. STIVERS, Mr. 

ROGERS of Kentucky, Mr. BARR, Mr. FORBES, Mr. CARNEY, Mr. LANCE, 

Mrs. ELLMERS, Mrs. BLACKBURN, Mrs. CAROLYN B. MALONEY of New 

York, Mr. GRIFFIN of Arkansas, Mr. CRENSHAW, Mr. LANKFORD, Mr. 

DENT, Mr. ROONEY, Mr. BARROW of Georgia, Mr. KINGSTON, Mrs. 

NOEM, Mr. LATTA, Mr. GRAVES of Georgia, Mr. ROSS, Mr. BISHOP of 

New York, Mr. PERLMUTTER, Mr. MURPHY of Pennsylvania, Mr. DIAZBALART, Mr. JOHNSON of Ohio, Mr. MATHESON, Mr. ROSKAM, Mr. 

FLEISCHMANN, Mr. CHABOT, and Mr. RENACCI

JULY 24, 2014 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on March 13, 2014] 

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A BILL 

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. 

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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Sunscreen Innovation 

5 Act’’. 

6 SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN 

7 ACTIVE INGREDIENTS. 

8 Chapter V of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 351 et seq.) is amended by adding at the 

10 end the following: 

11 ‘‘Subchapter I—Nonprescription Sunscreen 

12 Active Ingredients 

13 ‘‘SEC. 586. DEFINITIONS. 

14 ‘‘In this subchapter: 

15 ‘‘(1) The term ‘Advisory Committee’ means the 

16 Nonprescription Drug Advisory Committee or any 

17 successor to such Committee. 

18 ‘‘(2) The terms ‘generally recognized as safe and 

19 effective’ and ‘GRASE’ mean generally recognized, 

20 among experts qualified by scientific training and ex21 perience to evaluate the safety and effectiveness of 

22 drugs, as safe and effective for use under the condi23 tions prescribed, recommended, or suggested in the 

24 product’s labeling, as described in section 201(p). 

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1 ‘‘(3) The term ‘GRASE determination’ means, 

2 with respect to a nonprescription sunscreen active in3 gredient or a combination of nonprescription sun4 screen active ingredients, a determination of whether 

5 such ingredients or combination of ingredients is gen6 erally recognized as safe and effective and not mis7 branded for use under the conditions prescribed, rec8 ommended, or suggested in the product’s labeling, as 

9 described in section 201(p). 

10 ‘‘(4) The term ‘nonprescription’ means not sub11 ject to section 503(b)(1). 

12 ‘‘(5) The term ‘pending request’ means each re13 quest submitted to the Secretary— 

14 ‘‘(A) for consideration for inclusion in the 

15 over-the-counter drug monograph system; 

16 ‘‘(B) that was deemed eligible for such re17 view by publication of a notice of eligibility in 

18 the Federal Register prior to the date of enact19 ment of the Sunscreen Innovation Act; and 

20 ‘‘(C) for which safety and effectiveness data 

21 has been submitted to the Secretary prior to such 

22 date of enactment. 

23 ‘‘(6) The term ‘sponsor’ means the person sub24 mitting the request under section 586A(a), including 

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1 a time and extent application under section 586B, or 

2 the person that submitted the pending request. 

3 ‘‘(7) The term ‘sunscreen active ingredient’ 

4 means an active ingredient that is intended for appli5 cation to the skin of humans for purposes of absorb6 ing, reflecting, or scattering radiation. 

7 ‘‘(8) The term ‘sunscreen’ means a product con8 taining one or more sunscreen active ingredients. 

9 ‘‘SEC. 586A. GENERAL PROVISIONS. 

10 ‘‘(a) REQUESTS.—Any person may submit a request 

11 to the Secretary for a determination of whether a non12 prescription sunscreen active ingredient or a combination 

13 of nonprescription sunscreen active ingredients, for use 

14 under specified conditions, to be prescribed, recommended, 

15 or suggested in the labeling thereof (including dosage form, 

16 dosage strength, and route of administration) is generally 

17 recognized as safe and effective and not misbranded. 

18 ‘‘(b) RULES OF CONSTRUCTION.— 

19 ‘‘(1) CURRENTLY MARKETED SUNSCREENS.— 

20 Nothing in this subchapter shall be construed to affect 

21 the marketing of sunscreens that are lawfully mar22 keted in the United States on or before the date of en23 actment of this subchapter. 

24 ‘‘(2) ENSURING SAFETY AND EFFECTIVENESS.— 

25 Nothing in this subchapter shall be construed to alter 

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1 the Secretary’s authority to prohibit the marketing of 

2 a sunscreen that is not safe and effective or to impose 

3 restrictions on the marketing of a sunscreen to ensure 

4 safety and effectiveness. 

5 ‘‘(3) OTHER PRODUCTS.—Nothing in this sub6 chapter shall be construed to affect the Secretary’s 

7 regulation of products other than sunscreens. 

8 ‘‘(c) SUNSET.—This subchapter shall cease to be effec9 tive at the end of the 5-year period beginning on the date 

10 of enactment of this subchapter. 

11 ‘‘SEC. 586B. ELIGIBILITY DETERMINATION. 

12 ‘‘(a) IN GENERAL.—Upon receipt of a request under 

13 section 586A(a), not later than 60 days after the date of 

14 receipt of such request, the Secretary shall— 

15 ‘‘(1) determine whether the request is eligible for 

16 further review under sections 586C and 586D, as de17 scribed in subsection (b); 

18 ‘‘(2) notify the sponsor of the Secretary’s deter19 mination; and 

20 ‘‘(3) make such determination publicly available 

21 in accordance with subsection (c). 

22 ‘‘(b) CRITERIA FOR ELIGIBILITY.— 

23 ‘‘(1) IN GENERAL.—To be eligible for review 

24 under sections 586C and 586D, a request shall be for 

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1 bination of nonprescription sunscreen active ingredi2 ents, for use under specified conditions, to be pre3 scribed, recommended, or suggested in the labeling 

4 thereof, that— 

5 ‘‘(A) is not included in the stayed sunscreen 

6 monograph in part 352 of title 21, Code of Fed7 eral Regulations; and 

8 ‘‘(B) has been used to a material extent and 

9 for a material time, as described in section 

10 201(p)(2). 

11 ‘‘(2) TIME AND EXTENT APPLICATION.—A spon12 sor shall include in a request under section 586A(a) 

13 a time and extent application including all the infor14 mation required to meet the standard described in 

15 paragraph (1)(B). 

16 ‘‘(c) PUBLIC AVAILABILITY.— 

17 ‘‘(1) REDACTIONS FOR CONFIDENTIAL INFORMA18 TION.—If a nonprescription sunscreen active ingre19 dient or combination of nonprescription sunscreen ac20 tive ingredients is determined to be eligible for further 

21 review under subsection (a)(1), the Secretary shall 

22 make the request publicly available, with redactions 

23 for information that is treated as confidential under 

24 section 552(b) of title 5, United States Code, section 

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1 1905 of title 18, United States Code, or section 301(j) 

2 of this Act. 

3 ‘‘(2) IDENTIFICATION OF CONFIDENTIAL INFOR4 MATION BY SPONSOR.—Sponsors shall identify any 

5 information which the sponsor considers to be con6 fidential information described in paragraph (1). 

7 ‘‘(3) CONFIDENTIALITY DURING ELIGIBILITY RE8 VIEW.—The information contained in a request under 

9 section 586A(a) shall remain confidential during the 

10 Secretary’s consideration under this section of wheth11 er the request is eligible for further review. 

12 ‘‘SEC. 586C. DATA SUBMISSION; FILING DETERMINATION. 

13 ‘‘(a) IN GENERAL.—In the case of a request under sec14 tion 586A(a) that is determined to be eligible under section 

15 586B for further review under this section and section 

16 586D— 

17 ‘‘(1) the Secretary shall, in notifying the public 

18 under section 586B(a)(3) of such eligibility deter19 mination, invite the sponsor of the request and any 

20 other interested party to submit, in support of or oth21 erwise relating to a GRASE determination— 

22 ‘‘(A) published and unpublished data and 

23 other information related to the safety and effec24 tiveness of the nonprescription sunscreen active 

25 ingredient or combination of nonprescription 

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1 sunscreen active ingredients for its intended non2 prescription uses; or 

3 ‘‘(B) any other comments; and 

4 ‘‘(2) not later than 60 days after the submission 

5 of such data and other information by the sponsor, 

6 including any revised submission of such data and 

7 other information following a refusal to file under 

8 subparagraph (B), the Secretary shall— 

9 ‘‘(A)(i) issue a written notification to the 

10 sponsor determining that the request under sec11 tion 586A(a), together with such data and other 

12 information, is sufficiently complete to conduct a 

13 substantive review and make such notification 

14 publicly available; and 

15 ‘‘(ii) file such request; or 

16 ‘‘(B) issue a written notification to the 

17 sponsor refusing to file the request and stating 

18 the reasons for the refusal and why the data and 

19 other information submitted is not sufficiently 

20 complete to conduct a substantive review and 

21 make such notification publicly available; 

22 ‘‘(3) the Secretary shall, in filing a request 

23 under paragraph (2)— 

24 ‘‘(A) invite the public to submit further 

25 comments with respect to such filing; and 

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1 ‘‘(B) limit such public comment, and the 

2 comment period under paragraph (1), to the pe3 riod ending on the date that is 60 days after 

4 such filing; 

5 ‘‘(4) if the Secretary refuses to file the request— 

6 ‘‘(A) the sponsor may, within 30 days of re7 ceipt of written notification of such refusal, seek 

8 a meeting with the Secretary regarding whether 

9 the Secretary should file the request; and 

10 ‘‘(B) the Secretary shall convene the meet11 ing; and 

12 ‘‘(5) following any such meeting— 

13 ‘‘(A) if the sponsor asks that the Secretary 

14 file the request (with or without amendments to 

15 correct any purported deficiencies to the request) 

16 the Secretary shall file the request over protest, 

17 issue a written notification of the filing to the 

18 sponsor, and make such notification publicly 

19 available; and 

20 ‘‘(B) if the request is so filed over protest, 

21 the Secretary shall not require the sponsor to re22 submit a copy of the request for purposes of such 

23 filing. 

24 ‘‘(b) REASONS FOR REFUSAL TO FILE REQUEST.—The 

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1 tion 586A(a) if the Secretary determines the data or other 

2 information submitted by the sponsor under this section are 

3 not sufficiently complete to conduct a substantive review 

4 with respect to such request. 

5 ‘‘(c) PUBLIC AVAILABILITY.— 

6 ‘‘(1) REDACTIONS FOR CONFIDENTIAL INFORMA7 TION.—The Secretary shall make data and other in8 formation submitted in connection with a request 

9 under section 586A(a) publicly available, with 

10 redactions for information that is treated as confiden11 tial under section 552(b) of title 5, United States 

12 Code, section 1905 of title 18, United States Code, or 

13 section 301(j) of this Act. 

14 ‘‘(2) IDENTIFICATION OF CONFIDENTIAL INFOR15 MATION BY SPONSOR.—Sponsors or any other indi16 vidual submitting data or other information under 

17 this section shall identify any information which the 

18 sponsor or individual considers to be confidential in19 formation described in paragraph (1). 

20 ‘‘SEC. 586D. GRASE DETERMINATION. 

21 ‘‘(a) REVIEW OF NEW REQUEST.— 

22 ‘‘(1) PROPOSED ORDER BY CDER.—In the case of 

23 a request under section 586A(a), the Director of the 

24 Center for Drug Evaluation and Research shall— 

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1 ‘‘(A) not later than 300 days after the date 

2 on which the request is filed under section 

3 586C(a), complete the review of the request and 

4 issue a proposed order determining that— 

5 ‘‘(i) the nonprescription sunscreen ac6 tive ingredient or combination of non7 prescription sunscreen active ingredients 

8 that is the subject of the request— 

9 ‘‘(I) is GRASE; and 

10 ‘‘(II) is not misbranded; 

11 ‘‘(ii) the nonprescription sunscreen ac12 tive ingredient or combination of non13 prescription sunscreen active ingredients 

14 that is the subject of the request— 

15 ‘‘(I) is not GRASE; or 

16 ‘‘(II) is misbranded; or 

17 ‘‘(iii) additional information is nec18 essary to allow the Director of the Center 

19 for Drug Evaluation and Research to com20 plete the review of such request; 

21 ‘‘(B) within such 300-day period, convene a 

22 meeting of the Advisory Committee to review the 

23 request under section 586A(a): and 

24 ‘‘(C) if the Director fails to issue such pro25 posed order within the 300-day period referred to 

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1 in subparagraph (A), transmit the request to the 

2 Commissioner of Food and Drugs for review. 

3 ‘‘(2) PROPOSED ORDER BY COMMISSIONER.— 

4 With respect to a request transmitted to the Commis5 sioner of Food and Drugs under paragraph (1)(C), 

6 the Commissioner shall, not later than 60 days after 

7 the date of such transmission, issue— 

8 ‘‘(A) a proposed order described in para9 graph (1)(A)(i); 

10 ‘‘(B) a proposed order described in para11 graph (1)(A)(ii); or 

12 ‘‘(C) a proposed order described in para13 graph (1)(A)(iii). 

14 ‘‘(3) PUBLICATION IN FEDERAL REGISTER; PUB15 LIC COMMENT PERIOD.—A proposed order issued 

16 under paragraph (1) or (2) with respect to a request 

17 shall— 

18 ‘‘(A) be published in the Federal Register; 

19 and 

20 ‘‘(B) solicit public comments for a period of 

21 not more than 45 days. 

22 ‘‘(4) FINAL ORDER BY CDER.—In the case of a 

23 proposed order under paragraph (1)(A) or (2) with 

24 respect to a request, the Director of the Center for 

25 Drug Evaluation and Research shall— 

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1 ‘‘(A) issue a final order with respect to the 

2 request— 

3 ‘‘(i) in the case of a proposed order 

4 under clause (i) or (ii) of paragraph (1)(A) 

5 or subparagraph (A) or (B) of paragraph 

6 (2), not later than 90 days after the end of 

7 the public comment period under paragraph 

8 (3)(B); or 

9 ‘‘(ii) in the case of a proposed order 

10 under paragraph (1)(A)(iii) or paragraph 

11 (2)(C), not later than 210 days after the 

12 date on which the sponsor submits the addi13 tional information requested pursuant to 

14 such proposed order; or 

15 ‘‘(B) if the Director fails to issue such final 

16 order within such 90- or 210-day period, as ap17 plicable, transmit such proposed order to the 

18 Commissioner of Food and Drugs for review. 

19 ‘‘(5) FINAL ORDER BY COMMISSIONER.—With re20 spect to a proposed order transmitted to the Commis21 sioner of Food and Drugs under paragraph (4)(B), 

22 the Commissioner shall issue a final order with re23 spect to such proposed order not later than 60 days 

24 after the date of such transmission. 

25 ‘‘(b) REVIEW OF PENDING REQUESTS.— 

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1 ‘‘(1) IN GENERAL.—The review of a pending re2 quest shall be carried out by the Director of the Center 

3 for Drug Evaluation and Research in accordance 

4 with paragraph (3). 

5 ‘‘(2) INAPPLICABILITY OF CERTAIN PROVI6 SIONS.—Sections 586B and 586C shall not apply 

7 with respect to any pending request. 

8 ‘‘(3) PROPOSED ORDER BY CDER.—The Director 

9 of the Center for Drug Evaluation and Research 

10 shall— 

11 ‘‘(A) within the timeframe applicable under 

12 paragraph (4), complete the review of the request 

13 and issue a proposed order determining that— 

14 ‘‘(i) the nonprescription sunscreen ac15 tive ingredient or combination of non16 prescription sunscreen active ingredients 

17 that is the subject of the pending request— 

18 ‘‘(I) is GRASE; and 

19 ‘‘(II) is not misbranded; 

20 ‘‘(ii) the nonprescription sunscreen ac21 tive ingredient or combination of non22 prescription sunscreen active ingredients 

23 that is the subject of the pending request— 

24 ‘‘(I) is not GRASE; or 

25 ‘‘(II) is misbranded; or 

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1 ‘‘(iii) additional information is nec2 essary to allow the Director of the Center 

3 for Drug Evaluation and Research to com4 plete the review of the pending request; and 

5 ‘‘(B) if the Director fails to issue such pro6 posed order within the timeframe applicable 

7 under paragraph (4), transmit the pending re8 quest to the Commissioner of Food and Drugs for 

9 review. 

10 ‘‘(4) TIMEFRAME FOR ISSUANCE OF PROPOSED

11 ORDER BY CDER.—The Director of the Center for 

12 Drug Evaluation and Research shall issue a proposed 

13 order, as required by paragraph (3)(A)— 

14 ‘‘(A) in the case of a pending request for 

15 which the Food and Drug Administration has 

16 issued a feedback letter before the date of enact17 ment of the Sunscreen Innovation Act, not later 

18 than 45 days after such date of enactment; and 

19 ‘‘(B) in the case of a pending request for 

20 which the Food and Drug Administration has 

21 not issued a feedback letter before the date of en22 actment of the Sunscreen Innovation Act, not 

23 later than 90 days after such date of enactment. 

24 ‘‘(5) PROPOSED ORDER BY COMMISSIONER.— 

25 With respect to a pending request transmitted to the 

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1 Commissioner of Food and Drugs under paragraph 

2 (3)(B), the Commissioner shall, not later than 60 

3 days after the date of such transmission, issue— 

4 ‘‘(A) a proposed order described in para5 graph (3)(A)(i); 

6 ‘‘(B) a proposed order described in para7 graph (3)(A)(ii); or 

8 ‘‘(C) a proposed order described in para9 graph (3)(A)(iii). 

10 ‘‘(6) PUBLICATION IN FEDERAL REGISTER; PUB11 LIC COMMENT PERIOD.—A proposed order issued 

12 under paragraph (3) or (5) with respect to a pending 

13 request shall— 

14 ‘‘(A) be published in the Federal Register; 

15 and 

16 ‘‘(B) solicit public comments for a period of 

17 not more than 45 days. 

18 ‘‘(7) ADVISORY COMMITTEE.—For a proposed 

19 order issued under paragraph (3)(A)(iii) or (5)(C) re20 questing additional information, an Advisory Com21 mittee meeting shall be convened if the sponsor re22 quests, or the Director of the Center for Drug Evalua23 tion and Research or the Commissioner of Food and 

24 Drugs decides, to convene such a meeting for the pur25 pose of reviewing the pending request. 

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1 ‘‘(8) FINAL ORDER BY CDER.—In the case of a 

2 proposed order under paragraph (3)(A) or (5) with 

3 respect to a request, the Director of the Center for 

4 Drug Evaluation and Research shall— 

5 ‘‘(A) issue a final order with respect to the 

6 request— 

7 ‘‘(i) in the case of a proposed order 

8 under clause (i) or (ii) of paragraph (3)(A) 

9 or subparagraph (A) or (B) of paragraph 

10 (5), not later than 90 days after the end of 

11 the public comment period under paragraph 

12 (3)(B); or 

13 ‘‘(ii) in the case of a proposed order 

14 under paragraph (3)(A)(iii) or paragraph 

15 (5)(C)— 

16 ‘‘(I) if the Advisory Committee is 

17 not convened pursuant to paragraph 

18 (7), not later than 210 days after the 

19 date on which the sponsor submits the 

20 additional information requested pur21 suant to such proposed order; or 

22 ‘‘(II) if the Advisory Committee is 

23 convened pursuant to paragraph (7), 

24 not later than 270 days after date on 

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1 which the sponsor submits such addi2 tional information; or 

3 ‘‘(B) if the Director fails to issue such final 

4 order within such 90-, 210-, and 270-day period, 

5 as applicable, transmit such proposed order to 

6 the Commissioner of Food and Drugs for review. 

7 ‘‘(9) FINAL ORDER BY COMMISSIONER.—With re8 spect to a proposed order transmitted to the Commis9 sioner of Food and Drugs under paragraph (8)(B), 

10 the Commissioner shall issue a final order with re11 spect to such proposed order not later than 60 days 

12 after the date of such transmission. 

13 ‘‘(c) ADVISORY COMMITTEE.— 

14 ‘‘(1) LIMITATIONS.—The Food and Drug Admin15 istration— 

16 ‘‘(A) shall not be required to convene the 

17 Advisory Committee— 

18 ‘‘(i) more than once with respect to 

19 any request under section 586A(a) or any 

20 pending request; or 

21 ‘‘(ii) more than twice in any twelve 

22 month period with respect to the review of 

23 submissions under this section; and 

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1 ‘‘(B) shall not be required to submit more 

2 than 3 submissions to the Advisory Committee 

3 per meeting. 

4 ‘‘(2) MEMBERSHIP.—In appointing the members 

5 of the Advisory Committee, the Secretary may select 

6 to serve temporarily as voting members on the Advi7 sory Committee— 

8 ‘‘(A) members of other Federal advisory 

9 committees; or 

10 ‘‘(B) consultants from outside of the Depart11 ment of Health and Human Services who have 

12 substantive expertise regarding sunscreen active 

13 ingredients. 

14 ‘‘(d) NO DELEGATION.—Any responsibility vested by 

15 this section in the Commissioner of Food and Drugs is not 

16 delegable. 

17 ‘‘(e) EFFECT OF FINAL ORDER.— 

18 ‘‘(1) CONTENT.—A final order under subsection 

19 (a)(4), (a)(5), (b)(8), or (b)(9) with respect to a re20 quest under section 586A(a) or a pending request 

21 shall determine that the nonprescription sunscreen ac22 tive ingredient or combination of nonprescription 

23 sunscreen active ingredients that is the subject of the 

24 request— 

25 ‘‘(A) is GRASE and is not misbranded; or 

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1 ‘‘(B) is not GRASE or is misbranded. 

2 ‘‘(2) ACTIVE INGREDIENTS DETERMINED TO BE

3 GRASE.—Upon issuance of a final order determining 

4 that a nonprescription sunscreen active ingredient or 

5 combination of nonprescription sunscreen active in6 gredients is GRASE and is not misbranded, the ac7 tive ingredient or combination of active ingredients 

8 shall be permitted to be introduced or delivered into 

9 interstate commerce, for use under the conditions sub10 ject to the final order, in accordance with all require11 ments applicable to drugs not subject to section 

12 503(b)(1). 

13 ‘‘(3) ACTIVE INGREDIENTS DETERMINED NOT TO

14 BE GRASE.—Upon issuance of a final order deter15 mining that the nonprescription sunscreen active in16 gredient or combination of nonprescription sunscreen 

17 active ingredients is not GRASE or is misbranded, 

18 the active ingredient or combination of active ingredi19 ents shall not be introduced or delivered into inter20 state commerce, for use under the conditions subject 

21 to the final order, unless an application submitted 

22 pursuant to section 505(b) with respect to such active 

23 ingredient or combination of active ingredients is ap24 proved. 

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1 ‘‘SEC. 586E. REPORTS. 

2 ‘‘(a) GAO REPORT.—Not later than 1 year after the 

3 date of enactment of the Sunscreen Innovation Act, the 

4 Comptroller General of the United States shall— 

5 ‘‘(1) submit a report reviewing the overall 

6 progress of the Secretary in carrying out this sub7 chapter to the Committee on Health, Education, 

8 Labor, and Pensions of the Senate and the Committee 

9 on Energy and Commerce of the House of Representa10 tives; and 

11 ‘‘(2) include findings on— 

12 ‘‘(A) the progress made in completing the 

13 review of pending requests; and 

14 ‘‘(B) the role of the Office of the Commis15 sioner of Food and Drugs in issuing determina16 tions with respect to pending requests, including 

17 the number of requests transferred to the Office 

18 of the Commissioner under section 586D. 

19 ‘‘(b) SECRETARY’S REPORT.— 

20 ‘‘(1) IN GENERAL.—Not later than 1 year after 

21 the date of enactment of the Sunscreen Innovation 

22 Act, and every 2 years thereafter, the Secretary shall 

23 issue a report to the Committee on Health, Edu24 cation, Labor, and Pensions of the Senate and the 

25 Committee on Energy and Commerce of the House of 

26 Representatives describing actions taken under this 

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1 section. Each report under this subsection shall be 

2 posted on the Internet site of the Food and Drug Ad3 ministration. 

4 ‘‘(2) CONTENTS.—The reports under this sub5 section shall include— 

6 ‘‘(A) a review of the progress made in 

7 issuing GRASE determinations for pending re8 quests, including the number of pending re9 quests— 

10 ‘‘(i) reviewed and the decision times 

11 for each request, measured from the date of 

12 the original request for an eligibility deter13 mination submitted by the sponsor; 

14 ‘‘(ii) resulting in a determination that 

15 the nonprescription sunscreen active ingre16 dient or combination of nonprescription 

17 sunscreen active ingredients is GRASE and 

18 not misbranded; 

19 ‘‘(iii) resulting in a determination that 

20 the nonprescription sunscreen active ingre21 dient or combination of nonprescription 

22 sunscreen active ingredients is not GRASE 

23 and is misbranded and the reasons for such 

24 determinations; and 

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1 ‘‘(iv) for which a determination has 

2 not been made, an explanation for the 

3 delay, a description of the current status of 

4 each such request, and the length of time 

5 each such request has been pending, meas6 ured from the date of original request for an 

7 eligibility determination by the sponsor; 

8 ‘‘(B) a review of the progress made in 

9 issuing in a timely manner GRASE determina10 tions for requests submitted under section 

11 586A(a), including the number of such re12 quests— 

13 ‘‘(i) reviewed and the decision times 

14 for each request; 

15 ‘‘(ii) resulting in a determination that 

16 the nonprescription sunscreen active ingre17 dient or combination of nonprescription 

18 sunscreen active ingredients is GRASE and 

19 not misbranded; 

20 ‘‘(iii) resulting in a determination that 

21 the nonprescription sunscreen active ingre22 dient or combination of nonprescription 

23 sunscreen active ingredients is not GRASE 

24 and is misbranded and the reasons for such 

25 determinations; and 

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1 ‘‘(iv) for which a determination has 

2 not been made, an explanation for the 

3 delay, a description of the current status of 

4 each such request, and the length of time 

5 each such request has been pending, meas6 ured from the date of original request for an 

7 eligibility determination by the sponsor; 

8 ‘‘(C) a description of the staffing and re9 sources relating to the costs associated with the 

10 review and decisionmaking pertaining to re11 quests under this subchapter; 

12 ‘‘(D) a review of the progress made in meet13 ing the deadlines with respect to processing re14 quests under this subchapter; 

15 ‘‘(E) to the extent the Secretary determines 

16 appropriate, recommendations for process im17 provements in the handling of pending and new 

18 requests, including the advisory committee re19 view process; and 

20 ‘‘(F) recommendations for expanding the 

21 applicability of this subchapter to nonprescrip22 tion active ingredients that are not related to the 

23 sunscreen category of over-the-counter drugs. 

24 ‘‘(c) METHOD.—The Secretary shall publish the re25 ports required under subsection (b) in the manner the Secmstockstill on DSK4VPTVN1PROD with BILLS

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1 retary determines to be the most effective for efficiently dis2 seminating the report, including publication of the report 

3 on the Internet website of the Food and Drug Administra4 tion.’’. 

5 SEC. 3. GUIDANCE. 

6 (a) IN GENERAL.— 

7 (1) ISSUANCE.—Not later than one year after the 

8 date of enactment of this Act, the Secretary of Health 

9 and Human Services, acting through the Commis10 sioner of Food and Drugs, shall issue guidance, in ac11 cordance with good guidance practices, on the imple12 mentation of, and compliance with, subchapter I of 

13 chapter V of the Federal Food, Drug, and Cosmetic 

14 Act, as added by section 2, including guidance on— 

15 (A) the criteria for determining whether a 

16 nonprescription sunscreen active ingredient or 

17 combination of nonprescription sunscreen active 

18 ingredients has been used to a material extent 

19 and for a material time, as described in section 

20 201(p)(2) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 321(p)(2)); 

22 (B) the format and content of a safety and 

23 effectiveness data submission; and 

24 (C) the safety and efficacy standards for de25 termining whether a nonprescription sunscreen 

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27 

•HR 4250 RH

1 active ingredients or combination of non2 prescription sunscreen active ingredients is gen3 erally recognized as safe and effective, as defined 

4 in section 586 of such subchapter I. 

5 (2) INAPPLICABILITY OF PAPERWORK REDUCTION

6 ACT.—Chapter 35 of title 44, United States Code, 

7 shall not apply to collections of information made for 

8 purposes of guidance under this subsection. 

9 (b) SUBMISSIONS PENDING ISSUANCE OF FINAL GUID10 ANCE.—Irrespective of whether final guidance under sub11 section (a) has been issued— 

12 (1) persons may, beginning on the date of enact13 ment of this Act, make submissions under subchapter 

14 I of chapter V of the Federal Food, Drug, and Cos15 metic Act, as added by section 2; and 

16 (2) the Secretary of Health and Human Serv17 ices, acting through the Commissioner of Food and 

18 Drugs, shall review and act upon such submissions in 

19 accordance with such subchapter. 

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Union Calendar No. 418 

113TH CONGRESS 

2D SESSION H. R. 4250 

[Report No. 113–558] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

poses. sunscreen active ingredients and for other purof safety and effectiveness of nonprescription Act to provide an alternative process for review 

JULY 24, 2014 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 

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