113TH CONGRESS 

2D SESSION S. 2141 

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 (a) IN GENERAL.—Chapter V of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend8 ed by adding at the end the following: 

9 ‘‘Subchapter I—Nonprescription Sunscreen 

10 and Other Active Ingredients 

11 ‘‘SEC. 586. DEFINITIONS. 

12 ‘‘In this subchapter— 

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

14 Nonprescription Drug Advisory Committee of the 

15 Food and Drug Administration or any successor to 

16 such Committee; 

17 ‘‘(2) the term ‘final sunscreen order’ means an 

18 order published by the Secretary in the Federal Reg19 ister containing information stating that a non20 prescription sunscreen active ingredient or combina21 tion of nonprescription sunscreen active ingredi22 ents— 

23 ‘‘(A) is GRASE and is not misbranded if 

24 marketed in accordance with such order; or 

25 ‘‘(B) is not GRASE and is misbranded; 
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1 ‘‘(3) the term ‘GRASE’ means generally recog2 nized, among experts qualified by scientific training 

3 and experience to evaluate the safety and effective4 ness of drugs, as safe and effective for use under the 

5 conditions prescribed, recommended, or suggested in 

6 the labeling of a drug as described in section 201(p); 

7 ‘‘(4) the term ‘GRASE determination’ means, 

8 with respect to a nonprescription active ingredient or 

9 a combination of nonprescription active ingredients, 

10 a determination of whether such ingredient or com11 bination of ingredients is GRASE; 

12 ‘‘(5) the term ‘nonprescription’ means not sub13 ject to section 503(b)(1); 

14 ‘‘(6) the term ‘pending request’ means each re15 quest with respect to a nonprescription sunscreen 

16 active ingredient submitted under section 330.14 of 

17 title 21, Code of Federal Regulations (as in effect on 

18 the date of enactment of the Sunscreen Innovation 

19 Act) for consideration for inclusion in the over-the20 counter drug monograph system— 

21 ‘‘(A) that was determined to be eligible for 

22 such review by publication of a notice of eligi23 bility in the Federal Register prior to the date 

24 of enactment of such Act; and 
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1 ‘‘(B) for which safety and effectiveness 

2 data have been submitted to the Secretary prior 

3 to such date of enactment; 

4 ‘‘(7) the term ‘proposed sunscreen order’ means 

5 an order containing a tentative determination pub6 lished by the Secretary in the Federal Register con7 taining information proposing that a nonprescription 

8 sunscreen active ingredient or combination of non9 prescription sunscreen active ingredients— 

10 ‘‘(A) is GRASE and is not misbranded if 

11 marketed in accordance with such order; 

12 ‘‘(B) is not GRASE and is misbranded; or 

13 ‘‘(C) is not GRASE and is misbranded be14 cause the data are insufficient to classify such 

15 ingredient or combination of ingredients as 

16 GRASE and not misbranded and additional in17 formation is necessary to allow the Secretary to 

18 determine otherwise; 

19 ‘‘(8) the term ‘sponsor’ means the person that 

20 submitted— 

21 ‘‘(A) a request under section 586A; 

22 ‘‘(B) a pending request; or 

23 ‘‘(C) any other application subject to this 

24 subchapter; 
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1 ‘‘(9) the term ‘sunscreen’ means a drug con2 taining one or more sunscreen active ingredients; 

3 and 

4 ‘‘(10) the term ‘sunscreen active ingredient’ 

5 means an active ingredient that is intended for ap6 plication to the skin of humans for purposes of ab7 sorbing, reflecting, or scattering ultraviolet radi8 ation. 

9 ‘‘SEC. 586A. SUBMISSION OF REQUESTS. 

10 ‘‘Any person may submit a request to the Secretary 

11 for a determination of whether a nonprescription sun12 screen active ingredient or a combination of nonprescrip13 tion sunscreen active ingredients, for use under specified 

14 conditions, to be prescribed, recommended, or suggested 

15 in the labeling thereof (including dosage form, dosage 

16 strength, and route of administration) is GRASE and 

17 should be included in part 352 of title 21, Code of Federal 

18 Regulations (or any successor regulations) concerning 

19 nonprescription sunscreen. 

20 ‘‘SEC. 586B. ELIGIBILITY DETERMINATIONS; DATA SUBMIS21 SION; FILING. 

22 ‘‘(a) ELIGIBILITY DETERMINATIONS.— 

23 ‘‘(1) IN GENERAL.—Not later than 60 calendar 

24 days after the date of receipt of a request under sec25 tion 586A, the Secretary shall— 
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1 ‘‘(A) determine, in accordance with para2 graph (2), whether the request is eligible for 

3 further review under subsection (b) and section 

4 586C; 

5 ‘‘(B) notify the sponsor of the determina6 tion of the Secretary; and 

7 ‘‘(C) make such determination publicly 

8 available in accordance with paragraph (3) and 

9 subsection (b)(1). 

10 ‘‘(2) CRITERIA FOR ELIGIBILITY.— 

11 ‘‘(A) IN GENERAL.—To be eligible for re12 view under subsection (b) and section 586C, a 

13 request shall be for a nonprescription sunscreen 

14 active ingredient or combination of nonprescrip15 tion sunscreen active ingredients, for use under 

16 specified conditions, to be prescribed, rec17 ommended, or suggested in the labeling thereof, 

18 that— 

19 ‘‘(i) is not included in part 352 of title 

20 21, Code of Federal Regulations (or any 

21 successor regulations) concerning non22 prescription sunscreen; and 

23 ‘‘(ii) has been used to a material ex24 tent and for a material time under such 
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1 conditions, as described in section 

2 201(p)(2). 

3 ‘‘(B) ESTABLISHMENT OF TIME AND EX4 TENT.—A sponsor shall include in a request 

5 under section 586A the information required 

6 under section 330.14 of title 21, Code of Fed7 eral Regulations (or any successor regulations) 

8 to meet the standard described in subparagraph 

9 (A)(ii). 

10 ‘‘(3) PUBLIC AVAILABILITY.— 

11 ‘‘(A) REDACTIONS FOR CONFIDENTIAL IN12 FORMATION.—If a nonprescription sunscreen 

13 active ingredient or combination of nonprescrip14 tion sunscreen active ingredients is determined 

15 under paragraph (1)(A) to be eligible for fur16 ther review, the Secretary shall make the re17 quest publicly available, with redactions for in18 formation that is treated as confidential under 

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

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

21 section 301(j) of this Act. 

22 ‘‘(B) IDENTIFICATION OF CONFIDENTIAL

23 INFORMATION BY SPONSOR.—At the time that 

24 a request is made under section 586A, the 

25 sponsor of such request shall identify any infor-
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1 mation that such sponsor considers to be con2 fidential information described in subparagraph 

3 (A). 

4 ‘‘(C) CONFIDENTIALITY DURING ELIGI5 BILITY REVIEW.—The information contained in 

6 a request under section 586A shall remain con7 fidential during the Secretary’s consideration 

8 under this section of whether the request is eli9 gible for further review consistent with section 

10 330.14 of title 21, Code of Federal Regulations 

11 (or any successor regulations). 

12 ‘‘(b) DATA SUBMISSION AND FILING OF RE13 QUESTS.— 

14 ‘‘(1) IN GENERAL.—In the case of a request 

15 under section 586A that is determined to be eligible 

16 under subsection (a) for further review under this 

17 section and section 586C, the Secretary shall, in no18 tifying the public under subsection (a)(1)(C) of such 

19 eligibility determination, post the eligibility deter20 mination on the Internet website of the Food and 

21 Drug Administration, invite the sponsor of such re22 quest and any other interested party to submit com23 ments, and provide a period of not less than 45 cal24 endar days for comments in support of or otherwise 

25 relating to a GRASE determination, including pub-
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1 lished and unpublished data and other information 

2 related to the safety and efficacy of such request. 

3 ‘‘(2) FILING DETERMINATION.—Not later than 

4 60 calendar days after the submission of data and 

5 other information described in paragraph (1) by the 

6 sponsor, the Secretary shall determine whether the 

7 data and other information submitted by the sponsor 

8 under this section are sufficiently complete, includ9 ing being formatted in a manner that enables the 

10 Secretary to determine the completeness of such 

11 data and information, to enable the Secretary to 

12 conduct a substantive review under section 586C 

13 with respect to such request. Not later than 60 cal14 endar days after the submission of data and other 

15 information described in paragraph (1) by the spon16 sor, if the Secretary determines— 

17 ‘‘(A) that such data and other information 

18 are sufficiently complete, the Secretary shall— 

19 ‘‘(i) issue a written notification to the 

20 sponsor of the determination to file such 

21 request, and make such notification pub22 licly available; and 

23 ‘‘(ii) file such request made under sec24 tion 586A; or 
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1 ‘‘(B) that such data and other information 

2 are not sufficiently complete, the Secretary 

3 shall issue a written notification to the sponsor 

4 of the determination to refuse to file the re5 quest, which shall include the reasons for the 

6 refusal, including why such data and other in7 formation are not sufficiently complete, and 

8 make such notification publicly available. 

9 ‘‘(3) REFUSAL TO FILE A REQUEST.— 

10 ‘‘(A) REQUEST FOR MEETINGS; SUBMIS11 SION OF ADDITIONAL DATA OR OTHER INFOR12 MATION.—If the Secretary refuses to file a re13 quest made under section 586A, the sponsor 

14 may— 

15 ‘‘(i) within 30 calendar days of receipt 

16 of written notification of such refusal, re17 quest, in writing, a meeting with the Sec18 retary regarding the filing determination; 

19 and 

20 ‘‘(ii) submit additional data or other 

21 information. 

22 ‘‘(B) MEETINGS.— 

23 ‘‘(i) IN GENERAL.—If a sponsor seeks 

24 a meeting under subparagraph (A)(i), the 

25 Secretary shall convene the meeting within 
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1 30 calendar days of the request for such 

2 meeting. 

3 ‘‘(ii) ACTIONS AFTER MEETING.—Fol4 lowing any meeting held under clause (i)— 

5 ‘‘(I) the Secretary may file the 

6 request within 60 calendar days; 

7 ‘‘(II) the sponsor may submit ad8 ditional data or other information; or 

9 ‘‘(III) if the sponsor elects, with10 in 120 calendar days, to have the Sec11 retary file the request (with or with12 out amendments to correct any pur13 ported deficiencies to the request)— 

14 ‘‘(aa) the Secretary shall file 

15 the request over protest, not later 

16 than 30 calendar days after the 

17 sponsor makes such election; 

18 ‘‘(bb) at the time of filing, 

19 the Secretary shall provide writ20 ten notification of such filing to 

21 the sponsor; and 

22 ‘‘(cc) the Secretary shall 

23 make such notification publicly 

24 available. 
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1 ‘‘(iii) REQUESTS FILED OVER PRO2 TEST.—The Secretary shall not require the 

3 sponsor to resubmit a copy of the request 

4 for purposes of filing a request filed over 

5 protest, as described in clause (ii)(III). 

6 ‘‘(C) SUBMISSIONS OF ADDITIONAL DATA

7 OR OTHER INFORMATION.—Within 60 calendar 

8 days of any submission of additional data or 

9 other information under subparagraph (A)(ii) 

10 or (B)(ii)(II), the Secretary shall reconsider the 

11 previous determination made under paragraph 

12 (2) with respect to the applicable request and 

13 make a new determination in accordance with 

14 paragraph (2). 

15 ‘‘(4) PUBLIC AVAILABILITY.— 

16 ‘‘(A) REDACTIONS FOR CONFIDENTIAL IN17 FORMATION.—After the period of confidentiality 

18 described in subsection (a)(3)(C), the Secretary 

19 shall make data and other information sub20 mitted in connection with a request under sec21 tion 586A publicly available, with redactions for 

22 information that is treated as confidential 

23 under section 552(b) of title 5, United States 

24 Code, section 1905 of title 18, United States 

25 Code, or section 301(j) of this Act. 
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1 ‘‘(B) IDENTIFICATION OF CONFIDENTIAL

2 INFORMATION BY SPONSOR.—A person submit3 ting information under this section shall iden4 tify at the time of such submission the portions 

5 of such information that the person considers to 

6 be confidential information described in sub7 paragraph (A). 

8 ‘‘SEC. 586C. GRASE DETERMINATION. 

9 ‘‘(a) REVIEW OF NEW REQUEST.— 

10 ‘‘(1) PROPOSED SUNSCREEN ORDER.—In the 

11 case of a request under section 586A, not later than 

12 300 calendar days after the date on which such re13 quest is filed under subsection (b)(2)(A) or 

14 (b)(3)(B)(ii)(III) of section 586B, the Secretary— 

15 ‘‘(A) may convene a meeting of the Advi16 sory Committee to review such request; and 

17 ‘‘(B) shall complete the review of such re18 quest and issue a proposed sunscreen order 

19 with respect to such request. 

20 ‘‘(2) PROPOSED SUNSCREEN ORDER BY COM21 MISSIONER.—If the Secretary does not issue a pro22 posed sunscreen order under paragraph (1)(B) with23 in such 300-day period, the sponsor of such request 

24 may notify the Office of the Commissioner of such 

25 request and request review by the Office of the Com-
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1 missioner. If such sponsor so notifies the Office of 

2 the Commissioner, the Commissioner shall, not later 

3 than 60 calendar days after the date of notification 

4 under this paragraph, issue a proposed sunscreen 

5 order with respect to such request. 

6 ‘‘(3) PUBLIC COMMENT PERIOD.—A proposed 

7 sunscreen order issued under paragraph (1)(B) or 

8 (2) with respect to a request shall provide for a pe9 riod of 45 calendar days for public comment. 

10 ‘‘(4) MEETING.—A sponsor may request, in 

11 writing, a meeting with respect to a proposed sun12 screen order issued under this subsection and de13 scribed in subparagraph (B) or (C) of section 

14 586(7), not later than 30 calendar days after the 

15 Secretary issues such order. The Secretary shall con16 vene a meeting with such sponsor not later than 45 

17 calendar days after such request for a meeting. 

18 ‘‘(5) FINAL SUNSCREEN ORDER.—With respect 

19 to a proposed sunscreen order under paragraph 

20 (1)(B) or (2)— 

21 ‘‘(A) the Secretary shall issue a final sun22 screen order— 

23 ‘‘(i) in the case of a proposed sun24 screen order described in subparagraph (A) 

25 or (B) of section 586(7), not later than 90 
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1 calendar days after the end of the public 

2 comment period under paragraph (3); or 

3 ‘‘(ii) in the case of a proposed sun4 screen order described in subparagraph (C) 

5 of section 586(7), not later than 210 cal6 endar days after the date on which the 

7 sponsor submits the additional information 

8 requested pursuant to such proposed sun9 screen order; or 

10 ‘‘(B) if the Secretary does not issue such 

11 final sunscreen order within such 90- or 210- 

12 calendar-day period, as applicable, the sponsor 

13 of such request may notify the Office of the 

14 Commissioner of such request and request re15 view by the Office of the Commissioner. 

16 ‘‘(6) FINAL SUNSCREEN ORDER BY COMMIS17 SIONER.—The Commissioner shall issue a final sun18 screen order with respect to a proposed sunscreen 

19 order subject to paragraph (5)(B) not later than 60 

20 calendar days after the date of notification under 

21 such paragraph. 

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

23 ‘‘(1) IN GENERAL.—The review of a pending re24 quest shall be carried out by the Secretary in ac25 cordance with this subsection. 
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1 ‘‘(2) INAPPLICABILITY OF SECTIONS 586A AND

2 586B.—Sections 586A and 586B shall not apply with 

3 respect to any pending request. 

4 ‘‘(3) FEEDBACK LETTERS AS PROPOSED SUN5 SCREEN ORDER.—Notwithstanding the requirements 

6 of section 586(7), a letter issued pursuant to section 

7 330.14(g) of title 21, Code of Federal Regulations 

8 before the date of enactment of the Sunscreen Inno9 vation Act, with respect to a pending request, shall 

10 be deemed to be a proposed sunscreen order and dis11 played on the Internet website of the Food and 

12 Drug Administration. Notification of the availability 

13 of such letter shall be published in the Federal Reg14 ister not later than 45 calendar days after the date 

15 of enactment of such Act. 

16 ‘‘(4) PROPOSED SUNSCREEN ORDER.—In the 

17 case of a pending request for which the Secretary 

18 has not issued a letter pursuant to section 330.14(g) 

19 of title 21, Code of Federal Regulations before the 

20 date of enactment of the Sunscreen Innovation Act, 

21 the Secretary shall complete review of such request 

22 and, not later than 90 calendar days after the date 

23 of enactment of such Act, issue a proposed sun24 screen order with respect to such request. 
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1 ‘‘(5) PROPOSED SUNSCREEN ORDER BY COM2 MISSIONER.—If the Secretary does not issue a pro3 posed sunscreen order under paragraph (4), or the 

4 Secretary does not publish a notification of the avail5 ability of a letter under paragraph (3), as applicable, 

6 the sponsor of such request may notify the Office of 

7 the Commissioner of such request and request re8 view by the Office of the Commissioner. The Com9 missioner shall, not later than 60 calendar days 

10 after the date of notification under this paragraph, 

11 issue a proposed order with respect to such request. 

12 ‘‘(6) PUBLIC COMMENT PERIOD.—A proposed 

13 sunscreen order issued under paragraph (4) or (5), 

14 or a notification of the availability of a letter under 

15 paragraph (3), with respect to a pending request 

16 shall provide for a period of 45 calendar days for 

17 public comment. 

18 ‘‘(7) MEETING.—A sponsor may request, in 

19 writing, a meeting with respect to a proposed sun20 screen order issued under this subsection, including 

21 a letter deemed to be a proposed sunscreen order 

22 under paragraph (3), not later than 30 calendar 

23 days after the Secretary issues such order or the 

24 date upon which such feedback letter is deemed to 

25 be a proposed sunscreen order, as applicable. The 
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1 Secretary shall convene a meeting with such sponsor 

2 not later than 45 calendar days after the date of 

3 such request for a meeting. 

4 ‘‘(8) ADVISORY COMMITTEE.—In the case of a 

5 proposed sunscreen order under paragraph (3), (4), 

6 or (5), an Advisory Committee meeting may be con7 vened for the purpose of reviewing and providing 

8 recommendations regarding the pending request. 

9 ‘‘(9) FINAL SUNSCREEN ORDER.—In the case 

10 of a proposed sunscreen order under paragraph (3), 

11 (4), or (5)— 

12 ‘‘(A) the Secretary shall issue a final sun13 screen order with respect to the request— 

14 ‘‘(i) in the case of a proposed sun15 screen order described in subparagraph (A) 

16 or (B) of section 586(7), not later than 90 

17 calendar days after the end of the public 

18 comment period under paragraph (6); or 

19 ‘‘(ii) in the case of a proposed sun20 screen order described in subparagraph (C) 

21 of section 586(7)— 

22 ‘‘(I) if the Advisory Committee is 

23 not convened under paragraph (8), 

24 not later than 210 calendar days after 

25 the date on which the sponsor submits 
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1 the additional information requested 

2 pursuant to such proposed sunscreen 

3 order, which shall include a rationale 

4 for not convening such Advisory Com5 mittee; or 

6 ‘‘(II) if the Advisory Committee 

7 is convened under paragraph (8), not 

8 later than 270 calendar days after the 

9 date on which the sponsor submits 

10 such additional information; or 

11 ‘‘(B) if the Secretary does not issue such 

12 final sunscreen order within such 90-, 210-, or 

13 270-calendar-day period, as applicable, the 

14 sponsor of such request may notify the Office 

15 of the Commissioner about such request and re16 quest review by the Office of the Commissioner. 

17 ‘‘(10) FINAL SUNSCREEN ORDER BY COMMIS18 SIONER.—The Commissioner shall issue a final sun19 screen order with respect to a proposed sunscreen 

20 order subject to paragraph (9)(B) not later than 60 

21 calendar days after the date of notification under 

22 such paragraph. 

23 ‘‘(c) ADVISORY COMMITTEE.—The Secretary shall 

24 not be required to— 

25 ‘‘(1) convene the Advisory Committee— 
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1 ‘‘(A) more than once with respect to any 

2 request under section 586A or any pending re3 quest; or 

4 ‘‘(B) more than twice in any calendar year 

5 with respect to the review under this section; or 

6 ‘‘(2) submit more than a total of 3 requests 

7 under section 586A or pending requests to the Advi8 sory Committee per meeting. 

9 ‘‘(d) NO DELEGATION.—Any responsibility vested in 

10 the Commissioner by subsection (a)(2), (a)(6), (b)(5), or 

11 (b)(10) shall not be delegated. 

12 ‘‘(e) EFFECT OF FINAL SUNSCREEN ORDER.— 

13 ‘‘(1) IN GENERAL.— 

14 ‘‘(A) SUNSCREEN ACTIVE INGREDIENTS

15 DETERMINED TO BE GRASE.—Upon issuance of 

16 a final sunscreen order determining that a non17 prescription sunscreen active ingredient or com18 bination of nonprescription sunscreen active in19 gredients is GRASE and is not misbranded, a 

20 sunscreen containing such ingredient or com21 bination of ingredients shall be permitted to be 

22 introduced or delivered into interstate com23 merce for use under the conditions described in 

24 such final sunscreen order, in accordance with 

25 all requirements applicable to drugs not subject 
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1 to section 503(b)(1), for so long as such final 

2 sunscreen order remains in effect. 

3 ‘‘(B) SUNSCREEN ACTIVE INGREDIENTS

4 DETERMINED NOT TO BE GRASE.—Upon 

5 issuance of a final sunscreen order determining 

6 that a nonprescription sunscreen active ingre7 dient or combination of nonprescription sun8 screen active ingredients is not GRASE and is 

9 misbranded, a sunscreen containing such ingre10 dient or combination of ingredients shall not be 

11 introduced or delivered into interstate com12 merce, for use under the conditions described in 

13 such final sunscreen order, unless an applica14 tion is approved pursuant to section 505 with 

15 respect to a sunscreen containing such ingre16 dient or combination of ingredients, or unless 

17 conditions are later established under which 

18 such ingredient or combination of ingredients is 

19 later determined to be GRASE and not mis20 branded under the over-the-counter drug mono21 graph system. 

22 ‘‘(2) AMENDMENTS TO FINAL SUNSCREEN OR23 DERS.— 

24 ‘‘(A) AMENDMENTS AT INITIATIVE OF SEC25 RETARY.—In the event that information rel-
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1 evant to a nonprescription sunscreen active in2 gredient or combination of nonprescription sun3 screen active ingredients becomes available to 

4 the Secretary after issuance of a final sunscreen 

5 order, the Secretary may amend such final sun6 screen order by issuing a new proposed sun7 screen order under subsection (a)(1) and fol8 lowing the procedures set forth in this section. 

9 ‘‘(B) PETITION TO AMEND FINAL

10 ORDER.—Any interested person may petition 

11 the Secretary to amend a final sunscreen order 

12 under section 10.30, title 21 Code of Federal 

13 Regulations (or any successor regulations). If 

14 the Secretary grants any petition under such 

15 section, the Secretary shall initiate the process 

16 for amending a final sunscreen order by issuing 

17 a new proposed sunscreen order under sub18 section (a)(1) and following the procedures set 

19 forth in this section. 

20 ‘‘(C) APPLICABILITY OF FINAL ORDERS.— 

21 Once the Secretary issues a new proposed sun22 screen order to amend a final sunscreen order 

23 under subparagraph (A) or (B), such final sun24 screen order shall remain in effect and para25 graph (3) shall not apply to such final sun-
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1 screen order until the Secretary has issued a 

2 new final sunscreen order or has determined 

3 not to amend the final sunscreen order. 

4 ‘‘(3) INCLUSION OF INGREDIENTS THAT ARE

5 SUBJECTS OF FINAL ORDERS IN THE SUNSCREEN

6 MONOGRAPH.— 

7 ‘‘(A) AMENDING REGULATIONS.— 

8 ‘‘(i) REQUIREMENT.—At any time 

9 that the Secretary proposes to amend part 

10 352 of title 21, Code of Federal Regula11 tions (or any successor regulations) con12 cerning nonprescription sunscreen, includ13 ing pursuant to section 586E, except as 

14 provided in clause (iv), the Secretary shall 

15 include in such part 352 (or any successor 

16 regulations) any nonprescription sunscreen 

17 active ingredient or combination of non18 prescription sunscreen active ingredients 

19 that is the subject of an effective final sun20 screen order of the type described in sec21 tion 586(2)(A) and issued since the time 

22 that the Secretary last amended such regu23 lations. Such regulation shall set forth con24 ditions of use under which each such ingre25 dient or combination of ingredients is 
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1 GRASE and not misbranded. If these con2 ditions differ from, or are in addition to, 

3 those previously set forth in the applicable 

4 final sunscreen order, the Secretary shall 

5 provide notice and opportunity for com6 ment on such conditions in the rulemaking, 

7 and the applicable final sunscreen order 

8 shall continue in effect until the effective 

9 date of a final regulation, as set forth in 

10 clause (iii). 

11 ‘‘(ii) INCLUSION OF ORDERS.—In pro12 posing to amend the regulations as de13 scribed in clause (i), the Secretary shall in14 clude in the proposed regulations a list of 

15 final sunscreen orders that shall cease to 

16 be effective on the effective date of a re17 sulting final regulation. Such list shall in18 clude all final sunscreen orders of the type 

19 described in section 586(2)(A) that are in 

20 effect on the date that such regulations are 

21 proposed, with the exception that such list 

22 shall not include any final sunscreen orders 

23 that, on the date that the regulations are 

24 proposed, the Secretary is in the process of 

25 amending under paragraph (2). 
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1 ‘‘(iii) ORDERS NO LONGER EFFEC2 TIVE.—Any final sunscreen order included 

3 by the Secretary in a list described in 

4 clause (ii) and in a list included in result5 ing final regulations shall cease to be effec6 tive on the date that such final regulations 

7 including such order in such list become ef8 fective. 

9 ‘‘(iv) INGREDIENTS NOT GRASE.—If, 

10 notwithstanding a final sunscreen order 

11 stating that a nonprescription sunscreen 

12 active ingredient or combination of non13 prescription sunscreen active ingredients is 

14 GRASE and is not misbranded if marketed 

15 in accordance with such order, while 

16 amending the regulations as described in 

17 clause (i), the Secretary concludes that 

18 such ingredient or combination of ingredi19 ents is no longer GRASE for use in non20 prescription sunscreen, the Secretary shall, 

21 at the discretion of the Secretary, either 

22 initiate the process for amending the final 

23 sunscreen order set forth in paragraph (2) 

24 of this subsection or include in a proposed 

25 regulation an explanation and information 
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1 supporting the determination of the Sec2 retary that such ingredient or combination 

3 of ingredients is no longer GRASE for use 

4 in nonprescription sunscreen. 

5 ‘‘(B) PROCEDURE FOR UPDATING REGULA6 TIONS.—After the Secretary amends and final7 izes the regulations under part 352 of title 21, 

8 Code of Federal Regulations under section 

9 586E and such regulations become effective, 

10 the Secretary may use direct final rulemaking 

11 to include in such regulations any nonprescrip12 tion sunscreen active ingredients that are the 

13 subject of effective final sunscreen orders. 

14 ‘‘SEC. 586D. GUIDANCE; OTHER PROVISIONS. 

15 ‘‘(a) GUIDANCE.— 

16 ‘‘(1) IN GENERAL.— 

17 ‘‘(A) DRAFT GUIDANCE.—Not later than 1 

18 year after the date of enactment of the Sun19 screen Innovation Act, the Secretary shall issue 

20 draft guidance on the implementation of, and 

21 compliance with, the requirements with respect 

22 to sunscreen under this subchapter, including 

23 guidance on— 

24 ‘‘(i) the format and content of infor25 mation submitted by a sponsor in support 
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1 of a request under section 586A or a pend2 ing request; 

3 ‘‘(ii) the data required to meet the 

4 safety and efficacy standard for deter5 mining whether a nonprescription sun6 screen active ingredient or combination of 

7 nonprescription sunscreen active ingredi8 ents is GRASE and is not misbranded; 

9 ‘‘(iii) the process by which a request 

10 under section 586A or a pending request is 

11 withdrawn; and 

12 ‘‘(iv) the process by which the Sec13 retary will carry out section 586C(c), in14 cluding with respect to how the Secretary 

15 will address the total number of requests 

16 received under section 586A and pending 

17 requests. 

18 ‘‘(B) FINAL GUIDANCE.—The Secretary 

19 shall finalize the guidance described in subpara20 graph (A) not later than 2 years after the date 

21 of enactment of the Sunscreen Innovation Act. 

22 ‘‘(C) INAPPLICABILITY OF PAPERWORK RE23 DUCTION ACT.—Chapter 35 of title 44, United 

24 States Code shall not apply to collections of in-
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1 formation made for purposes of guidance under 

2 this subsection. 

3 ‘‘(2) SUBMISSIONS PENDING ISSUANCE OF

4 FINAL GUIDANCE.—Irrespective of whether final 

5 guidance under paragraph (1) has been issued— 

6 ‘‘(A) persons may, beginning on the date 

7 of enactment of the Sunscreen Innovation Act, 

8 make submissions under this subchapter; and 

9 ‘‘(B) the Secretary shall review and act 

10 upon such submissions in accordance with this 

11 subchapter. 

12 ‘‘(b) RULES OF CONSTRUCTION.— 

13 ‘‘(1) CURRENTLY MARKETED SUNSCREENS.— 

14 Nothing in this subchapter shall be construed to af15 fect the marketing of sunscreens that are marketed 

16 in interstate commerce on or before the date of en17 actment of this subchapter, except as otherwise pro18 vided in this subchapter. 

19 ‘‘(2) ENSURING SAFETY AND EFFECTIVE20 NESS.—Nothing in this subchapter shall be con21 strued to alter the authority of the Secretary with 

22 respect to prohibiting the marketing of a sunscreen 

23 that is not safe and effective or is misbranded, or 

24 with respect to imposing restrictions on the mar25 keting of a sunscreen to ensure safety and effective-
29 

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1 ness, except as otherwise provided in this sub2 chapter, including section 586C(e). 

3 ‘‘(3) OTHER DRUGS.—Except as otherwise pro4 vided in section 586F, nothing in this subchapter 

5 shall be construed to affect the authority of the Sec6 retary under this Act or the Public Health Service 

7 Act (42 U.S.C. 201 et seq.) with respect to a drug 

8 other than a nonprescription sunscreen. 

9 ‘‘(4) EFFECT ON DRUGS OTHERWISE AP10 PROVED.—Nothing in this subchapter shall affect 

11 the marketing of a drug approved under section 505 

12 of this Act or section 351 of the Public Health Serv13 ice Act. 

14 ‘‘(c) TIMELINES.—The timelines for the processes 

15 and procedures under paragraphs (1), (2), (5), and (6) 

16 of section 586C(a) shall not apply to any requests sub17 mitted to the Secretary under section 586A after the date 

18 that is 6 years after the date of enactment of the Sun19 screen Innovation Act. 

20 ‘‘SEC. 586E. SUNSCREEN MONOGRAPH. 

21 ‘‘(a) IN GENERAL.—Not later than 5 years after the 

22 date of enactment of the Sunscreen Innovation Act, the 

23 Secretary shall amend and finalize regulations under part 

24 352 of title 21, Code of Federal Regulations concerning 

25 nonprescription sunscreen that are effective not later than 
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1 5 years after such date of enactment. The Secretary shall 

2 publish such regulations not less than 30 calendar days 

3 before the effective date of such regulations. 

4 ‘‘(b) REPORTS.—If the regulations promulgated 

5 under subsection (a) do not include provisions related to 

6 the effectiveness of various sun protection factor levels, 

7 and do not address all dosage forms known to the Sec8 retary to be used in sunscreens marketed in the United 

9 States without a new drug approval under section 505, 

10 the Secretary shall submit a report to the Committee on 

11 Health, Education, Labor, and Pensions of the Senate and 

12 the Committee on Energy and Commerce of the House 

13 of Representatives on the rationale for such provisions not 

14 being included in such regulations, and a plan and 

15 timeline to compile any information necessary to address 

16 such provisions through final regulations.’’. 

17 (b) RULES OF CONSTRUCTION.—Nothing in the 

18 amendment made by this section shall be construed to— 

19 (1) limit the right of a sponsor (as defined in 

20 section 586(8) of the Federal Food, Drug, and Cos21 metic Act, as added by subsection (a)) to request 

22 that the Secretary of Health and Human Services 

23 convene an advisory committee; or 

24 (2) limit the authority of the Secretary of 

25 Health and Human Services to meet with a sponsor 
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1 (as defined in section 586(8) of the Federal Food, 

2 Drug, and Cosmetic Act, as added by subsection 

3 (a)). 

4 SEC. 3. NON-SUNSCREEN TIME AND EXTENT APPLICA5 TIONS. 

6 Subchapter I of chapter V of the Federal Food, Drug, 

7 and Cosmetic Act, as added by section 2, is amended by 

8 adding at the end the following: 

9 ‘‘SEC. 586F. NON-SUNSCREEN TIME AND EXTENT APPLICA10 TIONS. 

11 ‘‘(a) PENDING TIME AND EXTENT APPLICATIONS.— 

12 ‘‘(1) IN GENERAL.— 

13 ‘‘(A) REQUEST FOR FRAMEWORK FOR RE14 VIEW.—If, prior to the date of enactment of the 

15 Sunscreen Innovation Act, an application was 

16 submitted pursuant to section 330.14 of title 

17 21, Code of Federal Regulations for a GRASE 

18 determination for a drug other than a non19 prescription sunscreen active ingredient or com20 bination of nonprescription sunscreen active in21 gredients and such drug was found to be eligi22 ble to be considered for inclusion in the over23 the-counter drug monograph system pursuant 

24 to section 330.14 of title 21, Code of Federal 

25 Regulations, the sponsor of such application 
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1 may request that the Secretary provide a 

2 framework under paragraph (2) for the review 

3 of such application. 

4 ‘‘(B) REQUEST REQUIREMENTS.—A re5 quest for a framework for review of an applica6 tion made under subparagraph (A) shall be 

7 made within 180 calendar days of the date of 

8 enactment of the Sunscreen Innovation Act and 

9 shall include the preference of such sponsor as 

10 to whether such application is reviewed by the 

11 Secretary in accordance with— 

12 ‘‘(i) the processes and procedures set 

13 forth for pending requests under section 

14 586C(b), except that specific timelines 

15 shall be determined in accordance with 

16 other applicable requirements under this 

17 section; 

18 ‘‘(ii) the processes and procedures set 

19 forth under part 330 of title 21, Code of 

20 Federal Regulations (or any successor reg21 ulations); 

22 ‘‘(iii) an initial filing determination 

23 under the processes and procedures de24 scribed in section 586B(b) and the proc25 esses and procedures set forth for pending 
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1 requests under section 586C(b), except 

2 that specific timelines shall be determined 

3 in accordance with other applicable re4 quirements under this section; or 

5 ‘‘(iv) an initial filing determination 

6 under the processes and procedures de7 scribed in section 586B(b) and the proc8 esses and procedures set forth under part 

9 330 of title 21, Code of Federal Regula10 tions (or any successor regulations). 

11 ‘‘(C) NO REQUEST.—If a sponsor de12 scribed in subparagraph (A) does not make 

13 such request within 180 calendar days of the 

14 date of enactment of the Sunscreen Innovation 

15 Act, such application shall be reviewed by the 

16 Secretary in accordance with the timelines of 

17 the applicable regulations when such regula18 tions are finalized under subsection (b). 

19 ‘‘(2) FRAMEWORK.—Not later than 1 year after 

20 the date of enactment of the Sunscreen Innovation 

21 Act, the Secretary shall provide, in writing, a frame22 work to each sponsor that submitted a request under 

23 paragraph (1). Such framework shall set forth the 

24 various timelines, in calendar days, with respect to 

25 the processes and procedures for review under 
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1 clauses (i), (ii), (iii), and (iv) of paragraph (1)(B) 

2 and— 

3 ‘‘(A) such timelines shall account for the 

4 considerations under paragraph (5); and 

5 ‘‘(B) the timelines for the various proc6 esses and procedures shall not be shorter than 

7 the timelines set forth for pending requests 

8 under sections 586B(b) and 586C(b), as appli9 cable. 

10 ‘‘(3) GOVERNING PROCESSES AND PROCEDURES

11 FOR REVIEW.— 

12 ‘‘(A) ELECTION.—Not later than 60 cal13 endar days after the Secretary provides a 

14 framework to a sponsor under paragraph (2), 

15 such sponsor may provide an election to the 

16 Secretary regarding the processes and proce17 dures for review under clause (i), (ii), (iii), or 

18 (iv) of paragraph (1)(B). If such sponsor makes 

19 such election, the Secretary shall review the ap20 plication that is the subject of such election 

21 pursuant to the processes and procedures elect22 ed by such sponsor and the applicable timelines 

23 in calendar days set forth under such frame24 work, which the Secretary shall confirm in writ25 ing to the sponsor not later than the date upon 
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1 which the Secretary provides a report under 

2 paragraph (4). If such sponsor does not make 

3 such election, such application shall be reviewed 

4 by the Secretary in accordance with the 

5 timelines of the applicable regulations when 

6 such regulations are finalized under subsection 

7 (b). 

8 ‘‘(B) DIFFERENT PROCESSES AND PROCE9 DURES.—At any time during review of an appli10 cation, the Secretary may review such applica11 tion under different processes and procedures 

12 under clause (i), (ii), (iii), or (iv) of paragraph 

13 (1)(B) than the processes and procedures the 

14 sponsor elected in accordance with subpara15 graph (A), so long as the Secretary proposes, in 

16 writing, the change and the sponsor agrees, in 

17 writing, to such change. 

18 ‘‘(C) INCLUSION OF INGREDIENTS IN

19 MONOGRAPHS.—If the sponsor elects to use the 

20 processes and procedures for review in accord21 ance with clause (i) or (iii) of paragraph (1)(B), 

22 the Secretary may incorporate any resulting 

23 final order into a regulation addressing the con24 ditions under which other drugs in the same 

25 therapeutic category are GRASE and not mis-
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1 branded, including through direct final rule2 making, and the final order so incorporated 

3 shall cease to be effective on the effective date 

4 of the final regulation that addresses such drug. 

5 ‘‘(4) LETTER REGARDING PENDING APPLICA6 TIONS.—Not later than 18 months after the date of 

7 enactment of the Sunscreen Innovation Act, the Sec8 retary shall report to the Committee on Health, 

9 Education, Labor, and Pensions of the Senate and 

10 the Committee on Energy and Commerce of the 

11 House of Representatives, in writing, regarding all 

12 pending applications subject to paragraph (1). In 

13 such letter, the Secretary shall provide a report on 

14 the review of such applications, including the 

15 timelines, in calendar days, for the review and 

16 GRASE determination for each application. Such 

17 timelines shall account for the considerations under 

18 paragraph (5). 

19 ‘‘(5) TIMELINES.—The timelines in calendar 

20 days established by the Secretary pursuant to this 

21 subsection— 

22 ‘‘(A) may vary based on the content, com23 plexity, and format of the application submitted 

24 to the Secretary; and 

25 ‘‘(B) shall— 
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1 ‘‘(i) reflect the public health priorities 

2 of the Food and Drug Administration, in3 cluding the potential public health benefits 

4 posed by the inclusion of additional drugs 

5 in the over-the-counter drug monograph 

6 system; 

7 ‘‘(ii) take into consideration the re8 sources available to the Secretary for car9 rying out such priorities and the processes 

10 and procedures described in paragraphs 

11 (1)(B) and (2); and 

12 ‘‘(iii) be reasonable, taking into con13 sideration the requirements described in 

14 clauses (i) and (ii). 

15 ‘‘(b) NEW TIME AND EXTENT APPLICATIONS.— 

16 ‘‘(1) IN GENERAL.—Not later than 18 months 

17 after the date of enactment of the Sunscreen Inno18 vation Act, the Secretary shall issue proposed regu19 lations establishing timelines for the review of appli20 cations for GRASE determinations for drugs other 

21 than nonprescription sunscreen active ingredients or 

22 combinations of nonprescription sunscreen active in23 gredients that are submitted to the Secretary after 

24 the date of enactment of the Sunscreen Innovation 

25 Act, under section 330.14 of title 21, Code of Fed-
38 

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1 eral Regulations (or any successor regulations), and 

2 that are found to be eligible to be considered for in3 clusion in the over-the-counter drug monograph sys4 tem pursuant to section 330.14 of title 21, Code of 

5 Federal Regulations (or any successor regulations), 

6 or that are subject to this subsection pursuant to 

7 paragraph (1) or (3) of subsection (a), as applicable, 

8 providing— 

9 ‘‘(A) timely and efficient completion of 

10 evaluations of applications under section 330.14 

11 of title 21, Code of Federal Regulations (or any 

12 successor regulations) for drugs other than sun13 screens; and 

14 ‘‘(B) timely and efficient completion of the 

15 review of the safety and effectiveness submis16 sions pursuant to such applications, including 

17 establishing— 

18 ‘‘(i) reasonable timelines, in calendar 

19 days, for the applicable proposed and final 

20 regulations for applications of various con21 tent, complexity, and format, and timelines 

22 for internal procedures related to such 

23 processes; and 
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1 ‘‘(ii) measurable metrics for tracking 

2 the extent to which the timelines set forth 

3 in the regulations are met. 

4 ‘‘(2) TIMELINES.—The timelines in calendar 

5 days established in the regulations under paragraph 

6 (1)— 

7 ‘‘(A) may vary based on the content, com8 plexity, and format of the application submitted 

9 to the Secretary; and 

10 ‘‘(B) shall— 

11 ‘‘(i) reflect the public health priorities 

12 of the Food and Drug Administration, in13 cluding the potential public health benefits 

14 posed by the inclusion of additional drugs 

15 in the over-the-counter drug monograph 

16 system; 

17 ‘‘(ii) take into consideration the re18 sources available to the Secretary for car19 rying out such priorities and the processes 

20 and procedures described in paragraph (1); 

21 and 

22 ‘‘(iii) be reasonable, taking into con23 sideration the requirements described in 

24 clauses (i) and (ii). 
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1 ‘‘(3) PROCEDURE.—In promulgating regula2 tions under this subsection, the Secretary shall issue 

3 a notice of proposed rulemaking that includes a copy 

4 of the proposed regulation, provide a period of not 

5 less than 60 calendar days for comments on the pro6 posed regulation, and publish the final regulation 

7 not less than 30 calendar days before the effective 

8 date of the regulation. 

9 ‘‘(4) RESTRICTIONS.—Notwithstanding any 

10 other provision of law, the Secretary shall promul11 gate regulations implementing this section only as 

12 described in paragraphs (1), (2), and (3). 

13 ‘‘(5) FINAL REGULATIONS.—The Secretary 

14 shall finalize the regulations under this section not 

15 later than 27 months after the date of enactment of 

16 the Sunscreen Innovation Act.’’. 

17 SEC. 4. REPORTS. 

18 (a) INITIAL GAO REPORT.—Not later than 3 years 

19 after the date of enactment of this Act, the Comptroller 

20 General of the United States shall submit to the Com21 mittee on Health, Education, Labor, and Pensions of the 

22 Senate and the Committee on Energy and Commerce of 

23 the House of Representatives a report reviewing the over24 all progress of the Secretary of Health and Human Serv25 ices in carrying out subchapter I of chapter V of the Fed-
41 

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1 eral Food, Drug, and Cosmetic Act (as added by section 

2 2 and amended by section 3 and subsection (c)), including 

3 findings on and recommendations with respect to— 

4 (1) the progress made in completing the review 

5 of requests under subchapter I of chapter V of the 

6 Federal Food, Drug, and Cosmetic Act, including 

7 pending requests, and the feasibility of the timelines 

8 associated with such subchapter; 

9 (2) the role of the Office of the Commissioner 

10 of Food and Drugs in issuing determinations with 

11 respect to requests reviewed under such subchapter, 

12 including the number of requests transferred to the 

13 Office of the Commissioner under section 586C of 

14 such Act; 

15 (3) the extent to which advisory committees 

16 were convened by the Secretary regarding requests 

17 under subchapter I of chapter V of the Federal 

18 Food, Drug, and Cosmetic Act, including pending 

19 requests; and 

20 (4) the types of metrics that have been, or 

21 should be, established for the review of time and ex22 tent applications. 

(b) SUBSEQUENT GAO REPORT.—Not later than 51 23 ⁄2

24 years after the date of enactment of this Act, the Comp25 troller General of the United States shall submit to the 
42 

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1 Committee on Health, Education, Labor, and Pensions of 

2 the Senate and the Committee on Energy and Commerce 

3 of the House of Representatives a report reviewing the 

4 overall progress of the Secretary of Health and Human 

5 Services in carrying out subchapter I of chapter V of the 

6 Federal Food, Drug, and Cosmetic Act (as added by sec7 tion 2 and amended by section 3 and subsection (c)) and 

8 the regulation of over-the-counter drug products, including 

9 findings on and recommendations with respect to— 

10 (1) updates on the matters reported on by the 

11 Comptroller General under subsection (a); 

12 (2) significant factors impacting the ability of 

13 the Food and Drug Administration to fulfill the mis14 sion of the agency with regard to the regulation of 

15 over-the-counter drug products, including finalizing 

16 outstanding monographs and responding to emerg17 ing and novel safety issues; 

18 (3) the performance of the Secretary in car19 rying out section 586E of the Federal Food, Drug, 

20 and Cosmetic Act; 

21 (4) the types of metrics that have been, or 

22 should be, established for the review and regulation 

23 of over-the-counter drug products; and 

24 (5) timeliness, efficiency, and accountability in 

25 reviewing time and extent applications and safety 
43 

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1 and effectiveness reviews for over-the-counter drug 

2 products. 

3 (c) FDA REPORT.—Subchapter I of chapter V of the 

4 Federal Food, Drug, and Cosmetic Act, as amended by 

5 section 3, is further amended by adding at the end the 

6 following: 

7 ‘‘SEC. 586G. REPORT. 

8 ‘‘(a) IN GENERAL.— 

9 ‘‘(1) IN GENERAL.—Not later than 18 months 

10 after the date of enactment of the Sunscreen Inno11 vation Act, and on the dates that are 2 and 4 years 

12 thereafter, the Secretary shall issue a report to the 

13 Committee on Health, Education, Labor, and Pen14 sions of the Senate and the Committee on Energy 

15 and Commerce of the House of Representatives de16 scribing actions taken under this subchapter. 

17 ‘‘(2) CONTENTS.—The reports under this sub18 section shall include— 

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

20 issuing GRASE determinations for pending re21 quests, including the number of pending re22 quests— 

23 ‘‘(i) reviewed and the decision times 

24 for each request, measured from the date 
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1 of the original request for an eligibility de2 termination submitted by the sponsor; 

3 ‘‘(ii) resulting in a determination that 

4 the nonprescription sunscreen active ingre5 dient or combination of nonprescription 

6 sunscreen active ingredients is GRASE 

7 and is not misbranded; 

8 ‘‘(iii) resulting in a determination that 

9 the nonprescription sunscreen active ingre10 dient or combination of nonprescription 

11 sunscreen active ingredients is not GRASE 

12 and is misbranded and the reasons for 

13 such determinations; and 

14 ‘‘(iv) for which a determination has 

15 not been made, and an explanation for the 

16 delay, a description of the current status of 

17 each such request, and the length of time 

18 each such request has been pending, meas19 ured from the date of original request for 

20 an eligibility determination by the sponsor; 

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

22 issuing GRASE determinations for requests not 

23 included in the reporting under subparagraph 

24 (A), including the number of such requests— 
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1 ‘‘(i) reviewed and the decision times 

2 for each request; 

3 ‘‘(ii) resulting in a determination that 

4 the nonprescription sunscreen active ingre5 dient, combination of nonprescription sun6 screen active ingredients, or other ingre7 dient is GRASE and is not misbranded; 

8 ‘‘(iii) resulting in a determination that 

9 the nonprescription sunscreen active ingre10 dient, combination of nonprescription sun11 screen active ingredients, or other ingre12 dient is not GRASE and is misbranded 

13 and the reasons for such determinations; 

14 and 

15 ‘‘(iv) for which a determination has 

16 not been made, and an explanation for the 

17 delay, a description of the current status of 

18 each such request, and the length of time 

19 each such request has been pending, meas20 ured from the date of original request for 

21 an eligibility determination by the sponsor; 

22 ‘‘(C) an annual accounting (including in23 formation from years prior to the date of enact24 ment of the Sunscreen Innovation Act where 

25 such information is available) of the total num-
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1 ber of requests submitted, pending, or com2 pleted under this subchapter, including whether 

3 such requests were the subject of an advisory 

4 committee convened by the Secretary; 

5 ‘‘(D) a description of the staffing and re6 sources relating to the costs associated with the 

7 review and decisionmaking pertaining to re8 quests under this subchapter; 

9 ‘‘(E) a review of the progress made in 

10 meeting the deadlines with respect to processing 

11 requests under this subchapter; and 

12 ‘‘(F) to the extent the Secretary deter13 mines appropriate, recommendations for process 

14 improvements in the handling of requests under 

15 this subchapter, including the advisory com16 mittee review process. 

17 ‘‘(b) METHOD.—The Secretary shall publish the re18 ports under subsection (a) in the manner the Secretary 

19 determines to be the most effective for efficiently dissemi20 nating the report, including publication of the report on 
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1 the Internet website of the Food and Drug Administra2 tion.’’. 

Passed the Senate September 17 (legislative day, 

September 16), 2014. 

Attest: 

Secretary. 
113TH CONGRESS 

2D SESSION S. 2141 

AN ACT 

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