II 

113TH CONGRESS 

2D SESSION H. R. 4250 

IN THE SENATE OF THE UNITED STATES 

JULY 29, 2014 

Received 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide an alternative process for review of safety and 

effectiveness of nonprescription sunscreen active ingredients and for other purposes. 

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


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1 SECTION 1. SHORT TITLE. 

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

3 Act’’. 

4 SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN 

5 ACTIVE INGREDIENTS. 

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

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

8 end the following: 

9 ‘‘Subchapter I—Nonprescription Sunscreen 

10 Active Ingredients 

11 ‘‘SEC. 586. DEFINITIONS. 

12 ‘‘In this subchapter: 

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

14 Nonprescription Drug Advisory Committee or any 

15 successor to such Committee. 

16 ‘‘(2) The terms ‘generally recognized as safe 

17 and effective’ and ‘GRASE’ mean generally recog18 nized, among experts qualified by scientific training 

19 and experience to evaluate the safety and effective20 ness of drugs, as safe and effective for use under the 

21 conditions prescribed, recommended, or suggested in 

22 the product’s labeling, as described in section 

23 201(p). 

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

25 with respect to a nonprescription sunscreen active 

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1 screen active ingredients, a determination of whether 

2 such ingredients or combination of ingredients is 

3 generally recognized as safe and effective and not 

4 misbranded for use under the conditions prescribed, 

5 recommended, or suggested in the product’s labeling, 

6 as described in section 201(p). 

7 ‘‘(4) The term ‘nonprescription’ means not sub8 ject to section 503(b)(1). 

9 ‘‘(5) The term ‘pending request’ means each re10 quest submitted to the Secretary— 

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

12 over-the-counter drug monograph system; 

13 ‘‘(B) that was deemed eligible for such re14 view by publication of a notice of eligibility in 

15 the Federal Register prior to the date of enact16 ment of the Sunscreen Innovation Act; and 

17 ‘‘(C) for which safety and effectiveness 

18 data has been submitted to the Secretary prior 

19 to such date of enactment. 

20 ‘‘(6) The term ‘sponsor’ means the person sub21 mitting the request under section 586A(a), including 

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

23 the person that submitted the pending request. 

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

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1 plication to the skin of humans for purposes of ab2 sorbing, reflecting, or scattering radiation. 

3 ‘‘(8) The term ‘sunscreen’ means a product 

4 containing one or more sunscreen active ingredients. 

5 ‘‘SEC. 586A. GENERAL PROVISIONS. 

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

7 to the Secretary for a determination of whether a non8 prescription sunscreen active ingredient or a combination 

9 of nonprescription sunscreen active ingredients, for use 

10 under specified conditions, to be prescribed, recommended, 

11 or suggested in the labeling thereof (including dosage 

12 form, dosage strength, and route of administration) is 

13 generally recognized as safe and effective and not mis14 branded. 

15 ‘‘(b) RULES OF CONSTRUCTION.— 

16 ‘‘(1) CURRENTLY MARKETED SUNSCREENS.— 

17 Nothing in this subchapter shall be construed to af18 fect the marketing of sunscreens that are lawfully 

19 marketed in the United States on or before the date 

20 of enactment of this subchapter. 

21 ‘‘(2) ENSURING SAFETY AND EFFECTIVE22 NESS.—Nothing in this subchapter shall be con23 strued to alter the Secretary’s authority to prohibit 

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1 fective or to impose restrictions on the marketing of 

2 a sunscreen to ensure safety and effectiveness. 

3 ‘‘(3) OTHER PRODUCTS.—Nothing in this sub4 chapter shall be construed to affect the Secretary’s 

5 regulation of products other than sunscreens. 

6 ‘‘(c) SUNSET.—This subchapter shall cease to be ef7 fective at the end of the 5-year period beginning on the 

8 date of enactment of this subchapter. 

9 ‘‘SEC. 586B. ELIGIBILITY DETERMINATION. 

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

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

12 receipt of such request, the Secretary shall— 

13 ‘‘(1) determine whether the request is eligible 

14 for further review under sections 586C and 586D, 

15 as described in subsection (b); 

16 ‘‘(2) notify the sponsor of the Secretary’s deter17 mination; and 

18 ‘‘(3) make such determination publicly available 

19 in accordance with subsection (c). 

20 ‘‘(b) CRITERIA FOR ELIGIBILITY.— 

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

22 under sections 586C and 586D, a request shall be 

23 for a nonprescription sunscreen active ingredient or 

24 combination of nonprescription sunscreen active in25 gredients, for use under specified conditions, to be 


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1 prescribed, recommended, or suggested in the label2 ing thereof, that— 

3 ‘‘(A) is not included in the stayed sun4 screen monograph in part 352 of title 21, Code 

5 of Federal Regulations; and 

6 ‘‘(B) has been used to a material extent 

7 and for a material time, as described in section 

8 201(p)(2). 

9 ‘‘(2) TIME AND EXTENT APPLICATION.—A 

10 sponsor shall include in a request under section 

11 586A(a) a time and extent application including all 

12 the information required to meet the standard de13 scribed in paragraph (1)(B). 

14 ‘‘(c) PUBLIC AVAILABILITY.— 

15 ‘‘(1) REDACTIONS FOR CONFIDENTIAL INFOR16 MATION.—If a nonprescription sunscreen active in17 gredient or combination of nonprescription sun18 screen active ingredients is determined to be eligible 

19 for further review under subsection (a)(1), the Sec20 retary shall make the request publicly available, with 

21 redactions for information that is treated as con22 fidential under section 552(b) of title 5, United 

23 States Code, section 1905 of title 18, United States 

24 Code, or section 301(j) of this Act. 


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1 ‘‘(2) IDENTIFICATION OF CONFIDENTIAL IN2 FORMATION BY SPONSOR.—Sponsors shall identify 

3 any information which the sponsor considers to be 

4 confidential information described in paragraph (1). 

5 ‘‘(3) CONFIDENTIALITY DURING ELIGIBILITY

6 REVIEW.—The information contained in a request 

7 under section 586A(a) shall remain confidential dur8 ing the Secretary’s consideration under this section 

9 of whether the request is eligible for further review. 

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

11 ‘‘(a) IN GENERAL.—In the case of a request under 

12 section 586A(a) that is determined to be eligible under 

13 section 586B for further review under this section and sec14 tion 586D— 

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

16 under section 586B(a)(3) of such eligibility deter17 mination, invite the sponsor of the request and any 

18 other interested party to submit, in support of or 

19 otherwise relating to a GRASE determination— 

20 ‘‘(A) published and unpublished data and 

21 other information related to the safety and ef22 fectiveness of the nonprescription sunscreen ac23 tive ingredient or combination of nonprescrip24 tion sunscreen active ingredients for its in25 tended nonprescription uses; or 


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1 ‘‘(B) any other comments; and 

2 ‘‘(2) not later than 60 days after the submis3 sion of such data and other information by the spon4 sor, including any revised submission of such data 

5 and other information following a refusal to file 

6 under subparagraph (B), the Secretary shall— 

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

8 sponsor determining that the request under sec9 tion 586A(a), together with such data and 

10 other information, is sufficiently complete to 

11 conduct a substantive review and make such no12 tification publicly available; and 

13 ‘‘(ii) file such request; or 

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

15 sponsor refusing to file the request and stating 

16 the reasons for the refusal and why the data 

17 and other information submitted is not suffi18 ciently complete to conduct a substantive review 

19 and make such notification publicly available; 

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

21 under paragraph (2)— 

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

23 comments with respect to such filing; and 

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

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1 riod ending on the date that is 60 days after 

2 such filing; 

3 ‘‘(4) if the Secretary refuses to file the re4 quest— 

5 ‘‘(A) the sponsor may, within 30 days of 

6 receipt of written notification of such refusal, 

7 seek a meeting with the Secretary regarding 

8 whether the Secretary should file the request; 

9 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 re16 quest) the Secretary shall file the request over 

17 protest, issue a written notification of the filing 

18 to the sponsor, and make such notification pub19 licly available; and 

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

21 the Secretary shall not require the sponsor to 

22 resubmit a copy of the request for purposes of 

23 such filing. 

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

25 The Secretary may refuse to file a request submitted 


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1 under section 586A(a) if the Secretary determines the 

2 data or other information submitted by the sponsor under 

3 this section are not sufficiently complete to conduct a sub4 stantive review with respect to such request. 

5 ‘‘(c) PUBLIC AVAILABILITY.— 

6 ‘‘(1) REDACTIONS FOR CONFIDENTIAL INFOR7 MATION.—The Secretary shall make data and other 

8 information submitted in connection with a request 

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

10 redactions for information that is treated as con11 fidential under section 552(b) of title 5, United 

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

13 Code, or section 301(j) of this Act. 

14 ‘‘(2) IDENTIFICATION OF CONFIDENTIAL IN15 FORMATION BY SPONSOR.—Sponsors or any other 

16 individual submitting data or other information 

17 under this section shall identify any information 

18 which the sponsor or individual considers to be con19 fidential information described in paragraph (1). 

20 ‘‘SEC. 586D. GRASE DETERMINATION. 

21 ‘‘(a) REVIEW OF NEW REQUEST.— 

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

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

24 the Center for Drug Evaluation and Research 

25 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 

22 a meeting of the Advisory Committee to review 

23 the request under section 586A(a); and 

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


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

2 the Commissioner of Food and Drugs for re3 view. 

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

5 With respect to a request transmitted to the Com6 missioner of Food and Drugs under paragraph 

7 (1)(C), the Commissioner shall, not later than 60 

8 days after the date of such transmission, issue— 

9 ‘‘(A) a proposed order described in para10 graph (1)(A)(i); 

11 ‘‘(B) a proposed order described in para12 graph (1)(A)(ii); or 

13 ‘‘(C) a proposed order described in para14 graph (1)(A)(iii). 

15 ‘‘(3) PUBLICATION IN FEDERAL REGISTER; 

16 PUBLIC COMMENT PERIOD.—A proposed order 

17 issued under paragraph (1) or (2) with respect to a 

18 request shall— 

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

20 and 

21 ‘‘(B) solicit public comments for a period 

22 of not more than 45 days. 

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

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


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

2 Drug Evaluation and Research shall— 

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

4 request— 

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

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

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

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

9 of the public comment period under para10 graph (3)(B); or 

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

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

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

14 date on which the sponsor submits the ad15 ditional information requested pursuant to 

16 such proposed order; or 

17 ‘‘(B) if the Director fails to issue such 

18 final order within such 90- or 210-day period, 

19 as applicable, transmit such proposed order to 

20 the Commissioner of Food and Drugs for re21 view. 

22 ‘‘(5) FINAL ORDER BY COMMISSIONER.—With 

23 respect to a proposed order transmitted to the Com24 missioner of Food and Drugs under paragraph 

25 (4)(B), the Commissioner shall issue a final order 


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1 with respect to such proposed order not later than 

2 60 days after the date of such transmission. 

3 ‘‘(b) REVIEW OF PENDING REQUESTS.— 

4 ‘‘(1) IN GENERAL.—The review of a pending re5 quest shall be carried out by the Director of the 

6 Center for Drug Evaluation and Research in accord7 ance with paragraph (3). 

8 ‘‘(2) INAPPLICABILITY OF CERTAIN PROVI9 SIONS.—Sections 586B and 586C shall not apply 

10 with respect to any pending request. 

11 ‘‘(3) PROPOSED ORDER BY CDER.—The Direc12 tor of the Center for Drug Evaluation and Research 

13 shall— 

14 ‘‘(A) within the timeframe applicable under 

15 paragraph (4), complete the review of the re16 quest and issue a proposed order determining 

17 that— 

18 ‘‘(i) the nonprescription sunscreen ac19 tive ingredient or combination of non20 prescription sunscreen active ingredients 

21 that is the subject of the pending re22 quest— 

23 ‘‘(I) is GRASE; and 

24 ‘‘(II) is not misbranded; 


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1 ‘‘(ii) the nonprescription sunscreen ac2 tive ingredient or combination of non3 prescription sunscreen active ingredients 

4 that is the subject of the pending re5 quest— 

6 ‘‘(I) is not GRASE; or 

7 ‘‘(II) is misbranded; or 

8 ‘‘(iii) additional information is nec9 essary to allow the Director of the Center 

10 for Drug Evaluation and Research to com11 plete the review of the pending request; 

12 and 

13 ‘‘(B) if the Director fails to issue such pro14 posed order within the timeframe applicable 

15 under paragraph (4), transmit the pending re16 quest to the Commissioner of Food and Drugs 

17 for review. 

18 ‘‘(4) TIMEFRAME FOR ISSUANCE OF PROPOSED

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

20 Drug Evaluation and Research shall issue a pro21 posed order, as required by paragraph (3)(A)— 

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

23 which the Food and Drug Administration has 

24 issued a feedback letter before the date of en25 actment of the Sunscreen Innovation Act, not 


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1 later than 45 days after such date of enact2 ment; and 

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

4 which the Food and Drug Administration has 

5 not issued a feedback letter before the date of 

6 enactment of the Sunscreen Innovation Act, not 

7 later than 90 days after such date of enact8 ment. 

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

10 With respect to a pending request transmitted to the 

11 Commissioner of Food and Drugs under paragraph 

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

13 days after the date of such transmission, issue— 

14 ‘‘(A) a proposed order described in para15 graph (3)(A)(i); 

16 ‘‘(B) a proposed order described in para17 graph (3)(A)(ii); or 

18 ‘‘(C) a proposed order described in para19 graph (3)(A)(iii). 

20 ‘‘(6) PUBLICATION IN FEDERAL REGISTER; 

21 PUBLIC COMMENT PERIOD.—A proposed order 

22 issued under paragraph (3) or (5) with respect to a 

23 pending request shall— 

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

25 and 


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1 ‘‘(B) solicit public comments for a period 

2 of not more than 45 days. 

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

4 order issued under paragraph (3)(A)(iii) or (5)(C) 

5 requesting additional information, an Advisory Com6 mittee meeting shall be convened if the sponsor re7 quests, or the Director of the Center for Drug Eval8 uation and Research or the Commissioner of Food 

9 and Drugs decides, to convene such a meeting for 

10 the purpose of reviewing the pending request. 

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

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

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

14 Drug Evaluation and Research shall— 

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

16 request— 

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

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

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

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

21 of the public comment period under para22 graph (3)(B); or 

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

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

25 (5)(C)— 


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1 ‘‘(I) if the Advisory Committee is 

2 not convened pursuant to paragraph 

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

4 date on which the sponsor submits the 

5 additional information requested pur6 suant to such proposed order; or 

7 ‘‘(II) if the Advisory Committee 

8 is convened pursuant to paragraph 

9 (7), not later than 270 days after date 

10 on which the sponsor submits such 

11 additional information; or 

12 ‘‘(B) if the Director fails to issue such 

13 final order within such 90-, 210-, and 270-day 

14 period, as applicable, transmit such proposed 

15 order to the Commissioner of Food and Drugs 

16 for review. 

17 ‘‘(9) FINAL ORDER BY COMMISSIONER.—With 

18 respect to a proposed order transmitted to the Com19 missioner of Food and Drugs under paragraph 

20 (8)(B), the Commissioner shall issue a final order 

21 with respect to such proposed order not later than 

22 60 days after the date of such transmission. 

23 ‘‘(c) ADVISORY COMMITTEE.— 

24 ‘‘(1) LIMITATIONS.—The Food and Drug Ad25 ministration— 


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

2 Advisory Committee— 

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

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

5 pending request; or 

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

7 month period with respect to the review of 

8 submissions under this section; and 

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

10 than 3 submissions to the Advisory Committee 

11 per meeting. 

12 ‘‘(2) MEMBERSHIP.—In appointing the mem13 bers of the Advisory Committee, the Secretary may 

14 select to serve temporarily as voting members on the 

15 Advisory Committee— 

16 ‘‘(A) members of other Federal advisory 

17 committees; or 

18 ‘‘(B) consultants from outside of the De19 partment of Health and Human Services who 

20 have substantive expertise regarding sunscreen 

21 active ingredients. 

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

23 this section in the Commissioner of Food and Drugs is 

24 not delegable. 

25 ‘‘(e) EFFECT OF FINAL ORDER.— 


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

2 (a)(4), (a)(5), (b)(8), or (b)(9) with respect to a re3 quest under section 586A(a) or a pending request 

4 shall determine that the nonprescription sunscreen 

5 active ingredient or combination of nonprescription 

6 sunscreen active ingredients that is the subject of 

7 the request— 

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

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

10 ‘‘(2) ACTIVE INGREDIENTS DETERMINED TO BE

11 GRASE.—Upon issuance of a final order determining 

12 that a nonprescription sunscreen active ingredient or 

13 combination of nonprescription sunscreen active in14 gredients is GRASE and is not misbranded, the ac15 tive ingredient or combination of active ingredients 

16 shall be permitted to be introduced or delivered into 

17 interstate commerce, for use under the conditions 

18 subject to the final order, in accordance with all re19 quirements applicable to drugs not subject to section 

20 503(b)(1). 

21 ‘‘(3) ACTIVE INGREDIENTS DETERMINED NOT

22 TO BE GRASE.—Upon issuance of a final order de23 termining that the nonprescription sunscreen active 

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1 branded, the active ingredient or combination of ac2 tive ingredients shall not be introduced or delivered 

3 into interstate commerce, for use under the condi4 tions subject to the final order, unless an application 

5 submitted pursuant to section 505(b) with respect to 

6 such active ingredient or combination of active in7 gredients is approved. 

8 ‘‘SEC. 586E. REPORTS. 

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

10 date of enactment of the Sunscreen Innovation Act, the 

11 Comptroller General of the United States shall— 

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

13 progress of the Secretary in carrying out this sub14 chapter to the Committee on Health, Education, 

15 Labor, and Pensions of the Senate and the Com16 mittee on Energy and Commerce of the House of 

17 Representatives; and 

18 ‘‘(2) include findings on— 

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

20 review of pending requests; and 

21 ‘‘(B) the role of the Office of the Commis22 sioner of Food and Drugs in issuing determina23 tions with respect to pending requests, includ24 ing the number of requests transferred to the 

25 Office of the Commissioner under section 586D. 


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1 ‘‘(b) SECRETARY’S REPORT.— 

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

3 the date of enactment of the Sunscreen Innovation 

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

5 issue a report to the Committee on Health, Edu6 cation, Labor, and Pensions of the Senate and the 

7 Committee on Energy and Commerce of the House 

8 of Representatives describing actions taken under 

9 this section. Each report under this subsection shall 

10 be posted on the Internet site of the Food and Drug 

11 Administration. 

12 ‘‘(2) CONTENTS.—The reports under this sub13 section shall include— 

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

15 issuing GRASE determinations for pending re16 quests, including the number of pending re17 quests— 

18 ‘‘(i) reviewed and the decision times 

19 for each request, measured from the date 

20 of the original request for an eligibility de21 termination submitted by the sponsor; 

22 ‘‘(ii) resulting in a determination that 

23 the nonprescription sunscreen active ingre24 dient or combination of nonprescription 


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1 sunscreen active ingredients is GRASE 

2 and not misbranded; 

3 ‘‘(iii) resulting in a determination that 

4 the nonprescription sunscreen active ingre5 dient or combination of nonprescription 

6 sunscreen active ingredients is not GRASE 

7 and is misbranded and the reasons for 

8 such determinations; and 

9 ‘‘(iv) for which a determination has 

10 not been made, an explanation for the 

11 delay, a description of the current status of 

12 each such request, and the length of time 

13 each such request has been pending, meas14 ured from the date of original request for 

15 an eligibility determination by the sponsor; 

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

17 issuing in a timely manner GRASE determina18 tions for requests submitted under section 

19 586A(a), including the number of such re20 quests— 

21 ‘‘(i) reviewed and the decision times 

22 for each request; 

23 ‘‘(ii) resulting in a determination that 

24 the nonprescription sunscreen active ingre25 dient or combination of nonprescription 


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1 sunscreen active ingredients is GRASE 

2 and not misbranded; 

3 ‘‘(iii) resulting in a determination that 

4 the nonprescription sunscreen active ingre5 dient or combination of nonprescription 

6 sunscreen active ingredients is not GRASE 

7 and is misbranded and the reasons for 

8 such determinations; and 

9 ‘‘(iv) for which a determination has 

10 not been made, an explanation for the 

11 delay, a description of the current status of 

12 each such request, and the length of time 

13 each such request has been pending, meas14 ured from the date of original request for 

15 an eligibility determination by the sponsor; 

16 ‘‘(C) a description of the staffing and re17 sources relating to the costs associated with the 

18 review and decisionmaking pertaining to re19 quests under this subchapter; 

20 ‘‘(D) a review of the progress made in 

21 meeting the deadlines with respect to processing 

22 requests under this subchapter; 

23 ‘‘(E) to the extent the Secretary deter24 mines appropriate, recommendations for process 

25 improvements in the handling of pending and 


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1 new requests, including the advisory committee 

2 review process; and 

3 ‘‘(F) recommendations for expanding the 

4 applicability of this subchapter to nonprescrip5 tion active ingredients that are not related to 

6 the sunscreen category of over-the-counter 

7 drugs. 

8 ‘‘(c) METHOD.—The Secretary shall publish the re9 ports required under subsection (b) in the manner the Sec10 retary determines to be the most effective for efficiently 

11 disseminating the report, including publication of the re12 port on the Internet website of the Food and Drug Admin13 istration.’’. 

14 SEC. 3. GUIDANCE. 

15 (a) IN GENERAL.— 

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

17 the date of enactment of this Act, the Secretary of 

18 Health and Human Services, acting through the 

19 Commissioner of Food and Drugs, shall issue guid20 ance, in accordance with good guidance practices, on 

21 the implementation of, and compliance with, sub22 chapter I of chapter V of the Federal Food, Drug, 

23 and Cosmetic Act, as added by section 2, including 

24 guidance on— 


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HR 4250 RDS 

1 (A) the criteria for determining whether a 

2 nonprescription sunscreen active ingredient or 

3 combination of nonprescription sunscreen active 

4 ingredients has been used to a material extent 

5 and for a material time, as described in section 

6 201(p)(2) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 321(p)(2)); 

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

9 effectiveness data submission; and 

10 (C) the safety and efficacy standards for 

11 determining whether a nonprescription sun12 screen active ingredients or combination of non13 prescription sunscreen active ingredients is gen14 erally recognized as safe and effective, as de15 fined in section 586 of such subchapter I. 

16 (2) INAPPLICABILITY OF PAPERWORK REDUC17 TION ACT.—Chapter 35 of title 44, United States 

18 Code, shall not apply to collections of information 

19 made for purposes of guidance under this sub20 section. 

21 (b) SUBMISSIONS PENDING ISSUANCE OF FINAL

22 GUIDANCE.—Irrespective of whether final guidance under 

23 subsection (a) has been issued— 

24 (1) persons may, beginning on the date of en25 actment of this Act, make submissions under subVerDate Sep 11 2014 00:22 Dec 18, 2014 Jkt 049200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H4250.RDS H4250

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HR 4250 RDS 

1 chapter I of chapter V of the Federal Food, Drug, 

2 and Cosmetic Act, as added by section 2; and 

3 (2) the Secretary of Health and Human Serv4 ices, acting through the Commissioner of Food and 

5 Drugs, shall review and act upon such submissions 

6 in accordance with such subchapter. 

Passed the House of Representatives July 28, 2014. 

Attest: KAREN L. HAAS, 

Clerk. 


emcdonald on DSK67QTVN1PROD with BILLS