II 

Calendar No. 568 

113TH CONGRESS 

2D SESSION S. 2141 

To amend the Federal Food, Drug, and Cosmetic Act to provide an alternative 

process for review of safety and effectiveness of nonprescription sunscreen 

active ingredients and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 13, 2014 

Mr. REED (for himself, Mr. ISAKSON, Mr. COONS, Mr. BROWN, Mr. CARPER, 

Mr. PORTMAN, Ms. AYOTTE, Mr. ROBERTS, Mr. KIRK, Ms. WARREN, Mr. 

MCCONNELL, Ms. LANDRIEU, Mr. PAUL, Mr. SCOTT, Mr. SCHUMER, 

Mrs. HAGAN, Mr. HARKIN, Mr. ALEXANDER, Mr. BURR, and Mr. BOOKER) introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

SEPTEMBER 17 (legislative day, SEPTEMBER 16), 2014 

Reported by Mr. HARKIN, with an amendment 

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

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. 

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 Subchapter A of chapter V (21 U.S.C. 351 et seq.) 

7 is amended by adding at the end the following: 

8 ‘‘SEC. 524B. PROCEDURES FOR CLASSIFYING SUNSCREEN 

9 ACTIVE INGREDIENTS. 

10 ‘‘(a) IN GENERAL.—The Secretary shall review and 

11 determine whether nonprescription sunscreen conditions 

12 are generally recognized as safe and effective and shall 

13 ensure that any such conditions that are marketed in the 

14 United States are appropriately labeled. 

15 ‘‘(b) DEFINITIONS.— 

16 ‘‘(1) ACTIVE INGREDIENT.—The term ‘active 

17 ingredient’ means any component that is intended to 

18 furnish pharmacological activity or other direct ef19 fect in the diagnosis, cure, mitigation, treatment, or 

20 prevention of disease, or to affect the structure or 

21 function of the body of humans or animals. The 

22 term includes components that may undergo chem23 ical change in the manufacture of a drug and may 

24 be present in a drug in a modified form intended to 

25 furnish the specified activity or effect. 


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1 ‘‘(2) SUNSCREEN ACTIVE INGREDIENT.—The 

2 term ‘sunscreen active ingredient’ means an active 

3 ingredient that absorbs, reflects, or scatters radi4 ation in the ultraviolet range at wavelengths from 

5 290 to 400 nanometers. 

6 ‘‘(3) SUNSCREEN CONDITION.—The term ‘sun7 screen condition’ means a sunscreen active ingre8 dient (or a combination of sunscreen active ingredi9 ents), dosage form, dosage strength, or route of ad10 ministration, marketed for a specific nonprescription 

11 use. 

12 ‘‘(c) CRITERIA FOR ELIGIBILITY.—To be eligible for 

13 review under this section, a sunscreen condition shall— 

14 ‘‘(1) not be included in the stayed sunscreen 

15 monograph; and 

16 ‘‘(2) have been marketed as a nonprescription 

17 sunscreen condition in the United States or at least 

18 1 other country, or marketed as a cosmetic or die19 tary supplement in 1 or more counties other than 

20 the United States— 

21 ‘‘(A) for a minimum of 5 continuous years; 

22 and 

23 ‘‘(B) in sufficient quantity, as determined 

24 by the Secretary based upon the information 

25 submitted under subparagraphs (D) and (E) of 


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1 subsection (d)(1) and, if applicable, subsection 

2 (d)(2)(A)(ii). 

3 ‘‘(d) APPLICATION FOR ELIGIBILITY.— 

4 ‘‘(1) IN GENERAL.—A sponsor of a nonprescrip5 tion sunscreen condition described in subsection (c) 

6 desiring to market such condition in the United 

7 States may submit an application to the Secretary, 

8 in such manner and containing such information as 

9 required by the Secretary, including the following: 

10 ‘‘(A) Basic information about the sun11 screen condition (including a description of each 

12 active ingredient, pharmacologic class, intended 

13 nonprescription use, nonprescription strength 

14 and dosage form, route of administration, and 

15 directions for use). 

16 ‘‘(B) A detailed chemical description of the 

17 sunscreen active ingredient that includes a full 

18 description of the drug substance, including its 

19 physical and chemical characteristics, the meth20 od of synthesis (or isolation) and purification of 

21 the drug substance, and any specifications and 

22 analytical methods necessary to ensure the 

23 identity, strength, quality, and purity of the 

24 drug substance, including reference to the cur25 rent edition of the official National Formulary, 


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1 the United States Pharmacopeia, or foreign 

2 compendiums, where applicable. 

3 ‘‘(C) A list of each country in which the 

4 sunscreen condition has been marketed. 

5 ‘‘(D) The cumulative total number of dos6 age units sold for each dosage form of the sun7 screen condition, including total weight of the 

8 active ingredient, package size for each dosage 

9 form in which the condition is marketed as non10 prescription, and an estimate of the minimum 

11 number of potential consumer exposures to the 

12 condition. 

13 ‘‘(E) The use pattern (according to the 

14 label) for each country in which the sunscreen 

15 condition is marketed and any changes in use 

16 pattern that have occurred over time. 

17 ‘‘(F) A list of all countries in which the 

18 sunscreen condition has been withdrawn from 

19 marketing or in which an application for non20 prescription marketing approval has been de21 nied and an explanation for such withdrawal or 

22 application denial. 

23 ‘‘(2) SUNSCREEN CONDITIONS THAT HAVE NOT

24 BEEN MARKETED IN THE UNITED STATES FOR 5

25 CONTINUOUS YEARS.— 


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1 ‘‘(A) IN GENERAL.—In the case of an ap2 plication with respect to a nonprescription sun3 screen condition that has not been marketed in 

4 the United States for 5 continuous years, in ad5 dition to the information required under para6 graph (1), the sponsor shall submit the fol7 lowing information for each country in which 

8 the sunscreen condition has been marketed: 

9 ‘‘(i) The manner in which the sun10 screen condition has been marketed to con11 sumers. If the sunscreen condition is mar12 keted to consumers as a nonprescription 

13 pharmacy only condition, the Secretary 

14 may require supplemental information. 

15 ‘‘(ii) A description of the population 

16 demographics and the source from which 

17 this information has been compiled, to en18 sure that the sunscreen condition’s use can 

19 be reasonably extrapolated to the popu20 lation of the United States. 

21 ‘‘(iii) A description of the country’s 

22 system for identifying adverse drug experi23 ences, especially those found in non24 prescription marketing experience, includ25 ing method of collection if applicable. 


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1 ‘‘(iv) A statement of how long the 

2 sunscreen condition has been marketed in 

3 each country and how long the current 

4 product labeling has been in use, accom5 panied by a copy of the current product la6 beling, including a translation into English 

7 of any labeling that is not in English, and 

8 a statement of whether the current product 

9 labeling has been authorized, accepted, or 

10 approved by a regulatory body in each 

11 country where the condition is marketed. 

12 ‘‘(v) A list of all countries where the 

13 sunscreen condition is marketed as a pre14 scription drug only and an explanation for 

15 such restriction. 

16 ‘‘(B) SUNSCREEN CONDITIONS THAT HAVE

17 BEEN MARKETED IN MORE THAN 5 COUN18 TRIES.— 

19 ‘‘(i) IN GENERAL.—In the case of a 

20 sunscreen condition that has been mar21 keted as a nonprescription sunscreen in 

22 more than 5 countries, with a minimum of 

23 5 continuous years of marketing in at least 

24 one such country, the sponsor— 


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1 ‘‘(I) may submit information in 

2 accordance with clauses (i) through 

3 (iv) of subparagraph (A) with respect 

4 to only 5 such countries, including— 

5 ‘‘(aa) the country with a 

6 minimum of 5 continuous years 

7 of nonprescription marketing; 

8 ‘‘(bb) the country with the 

9 longest duration of marketing; 

10 and 

11 ‘‘(cc) the country with the 

12 most support for marketing, such 

13 as a large volume of sales with 

14 cultural diversity among users of 

15 the product; and 

16 ‘‘(II) shall explain the basis for 

17 the countries selected under subclause 

18 (I); and 

19 ‘‘(III) shall provide information 

20 from more than 5 countries if such in21 formation is needed to support the ap22 plication. 

23 ‘‘(ii) REQUIREMENT.—If the sun24 screen condition meets the criteria under 

25 items (aa) through (cc) of clause (i)(I) in 


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1 1 or more countries listed in section 

2 802(b)(1)(A), at least 1 such country shall 

3 be included among the 5 countries selected 

4 under such clause (i)(I). 

5 ‘‘(3) PENDING APPLICATIONS.—The require6 ments of this subsection shall not apply to a sun7 screen condition deemed eligible for review of safety 

8 and effectiveness by publication of a notice of eligi9 bility in the Federal Register prior to the date of en10 actment of the Sunscreen Innovation Act. Applica11 tions for such sunscreen conditions shall be consid12 ered in accordance with subsection (g). 

13 ‘‘(e) PUBLIC AVAILABILITY.—If a condition is found 

14 eligible under subsection (d), the Secretary shall make the 

15 application publicly available, with redactions for confiden16 tial commercial information or trade secret information, 

17 and any other information exempt from disclosure pursu18 ant to section 1905 of title 18, United States Code, section 

19 552(b) of title 5, United States Code, or section 301(j) 

20 of this Act. Applications shall remain confidential during 

21 the Secretary’s consideration of eligibility. 

22 ‘‘(f) NEW SUNSCREEN CONDITION APPLICATION.— 

23 ‘‘(1) ELIGIBILITY DETERMINATION.—Not later 

24 than 60 days after the submission of an eligibility 

25 application under subsection (d), the Secretary shall 


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1 determine if the sunscreen condition is eligible for 

2 further review for safety and effectiveness. In the 

3 case of a sunscreen condition determined to be eligi4 ble, the Secretary shall publish a notice of eligibility 

5 in the Federal Register, and provide interested per6 sons an opportunity to submit published and unpub7 lished data related to the safety and effectiveness of 

8 the sunscreen condition for its intended nonprescrip9 tion uses, in accordance with paragraph (2). In the 

10 case of a sunscreen condition determined not eligi11 ble, the Secretary shall issue a letter to the sponsor, 

12 which shall be made publicly available. 

13 ‘‘(2) SAFETY AND EFFECTIVENESS DATA SUB14 MISSIONS.— 

15 ‘‘(A) IN GENERAL.—Within 60 days of the 

16 publication in the Federal Register of an appli17 cation deemed eligible, as described in para18 graph (1), the sponsor and other interested par19 ties shall submit safety and effectiveness data 

20 to the Secretary for further review, as described 

21 in subparagraph (B). 

22 ‘‘(B) REQUIRED SUBMISSIONS REGARDING

23 DATA.—Submissions under this paragraph shall 

24 include the following: 

25 ‘‘(i) HUMAN SAFETY DATA.— 


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1 ‘‘(I) INDIVIDUAL ACTIVE COMPO2 NENTS.—With respect to individual 

3 active components, controlled studies, 

4 partially controlled or uncontrolled 

5 studies, documented case reports, per6 tinent marketing experiences that may 

7 influence a determination as to the 

8 safety of each individual active compo9 nent, and pertinent medical and sci10 entific literature. 

11 ‘‘(II) COMBINATIONS OF INDI12 VIDUAL ACTIVE COMPONENTS.—With 

13 respect to combinations of the indi14 vidual active components, controlled 

15 studies, partially controlled or uncon16 trolled studies, documented case re17 ports, pertinent marketing experiences 

18 that may influence a determination as 

19 to the safety of combinations of the 

20 individual active component, and per21 tinent medical and scientific lit22 erature. 

23 ‘‘(ii) EFFICACY DATA.— 

24 ‘‘(I) INDIVIDUAL ACTIVE COMPO25 NENTS.—With respect to individual 


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1 active components, controlled studies, 

2 partially controlled or uncontrolled 

3 studies, documented case reports, per4 tinent marketing experiences that may 

5 influence a determination on the effi6 cacy of each individual active compo7 nent, pertinent medical and scientific 

8 literature. 

9 ‘‘(II) COMBINATIONS OF INDI10 VIDUAL ACTIVE COMPONENTS.—With 

11 respect to combinations of the indi12 vidual active components, controlled 

13 studies, partially controlled or uncon14 trolled studies, documented case re15 ports, pertinent marketing experiences 

16 that may influence a determination on 

17 the efficacy of combinations of the in18 dividual active components, and perti19 nent medical and scientific literature. 

20 ‘‘(iii) DATA SETTING FORTH MEDICAL

21 RATIONALE AND PURPOSE.—A summary of 

22 the data and views setting forth the med23 ical rationale and purpose (or lack thereof) 

24 for the sunscreen condition and the sci25 entific basis (or lack thereof) for the conVerDate Sep 11 2014 23:00 Sep 17, 2014 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6401 E:\BILLS\S2141.RS S2141

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1 clusion that the condition has been proven 

2 safe and effective for the intended use. If 

3 there is an absence of controlled studies in 

4 the material submitted, an explanation as 

5 to why such studies are not considered 

6 necessary must be included. 

7 ‘‘(iv) OFFICIAL DRUG MONOGRAPH.— 

8 An applicable United States Pharma9 copoeia or National Formulary for the sun10 screen active ingredient or a proposed 

11 standard for inclusion in an article to be 

12 recognized in an official drug monograph 

13 for the active ingredient, including infor14 mation showing that the official or pro15 posed compendial monograph for the active 

16 ingredient is consistent with the active in17 gredient used in the studies establishing 

18 safety and effectiveness and with the active 

19 ingredient marketed in the nonprescription 

20 product to a material extent and for a ma21 terial time. If differences exist between the 

22 official or proposed compendial monograph 

23 for the active ingredient and the active in24 gredient that is the subject of the applica25 tion, sponsor shall explain such differences. 


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1 ‘‘(v) ADVERSE DRUG EXPERIENCES.— 

2 A list of all serious adverse drug experi3 ences, as defined by the Secretary, from 

4 each country where the condition has been 

5 or is currently marketed as a prescription 

6 drug or as a nonprescription drug or prod7 uct. 

8 ‘‘(C) OPTIONAL ANIMAL SAFETY DATA.— 

9 In addition to the information required under 

10 subparagraph (B), the sponsor may submit in11 formation with respect to animal safety data, 

12 including controlled studies and partially con13 trolled or uncontrolled studies, in the case of an 

14 application for individual active components, 

15 and controlled studies and partially controlled 

16 or uncontrolled studies in the case of an appli17 cation for combinations of individual active 

18 components. 

19 ‘‘(D) CONFIDENTIALITY OF SUBMIS20 SIONS.—The Secretary shall make data and in21 formation submitted by the sponsor, or pursu22 ant to a notice requesting safety and effective23 ness data published in the Federal Register, 

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1 formation, and any other information exempt 

2 from disclosure pursuant to section 1905 of 

3 title 18, United States Code, section 552(b) of 

4 title 5, United States Code, or section 301(j) of 

5 this Act. 

6 ‘‘(3) NEW SUNSCREEN CONDITION APPLICATION

7 SUBMISSION TO THE ADVISORY COMMITTEE.—Not 

8 later than 30 days after the end of the public com9 ment period described in paragraph (2), the Sec10 retary shall submit the application and the safety 

11 and effectiveness data submitted under paragraph 

12 (2) to the Nonprescription Drugs Advisory Com13 mittee (referred to in this section as the ‘advisory 

14 committee’) for review. 

15 ‘‘(g) PENDING SUNSCREEN CONDITION APPLICA16 TIONS.—Not later than 30 days after the date of enact17 ment of the Sunscreen Innovation Act, the Secretary shall 

18 submit to the advisory committee all safety and effective19 ness data submitted with respect to each application for 

20 review of sunscreen conditions that the Secretary had de21 termined, prior to the date of enactment of the Sunscreen 

22 Innovation Act, to be eligible for review of safety and ef23 fectiveness and for which the information required under 

24 subsection (f)(2) has been submitted to the Secretary prior 

25 to such date of enactment. 


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1 ‘‘(h) REVIEW AND RECOMMENDATION FOR NON2 PRESCRIPTION SUNSCREEN CONDITION.— 

3 ‘‘(1) IN GENERAL.—The Secretary shall require 

4 the advisory committee to evaluate the safety and ef5 fectiveness data submitted in accordance with sub6 section (f)(2) or (g). 

7 ‘‘(2) STANDARDS.—In evaluating a non8 prescription sunscreen condition under paragraph 

9 (1), the advisory committee shall use the regulations 

10 in effect at the time of the application, including 

11 regulations with respect to— 

12 ‘‘(A) the safety of the nonprescription sun13 screen condition; 

14 ‘‘(B) the effectiveness of the nonprescrip15 tion sunscreen condition; 

16 ‘‘(C) the benefit-to-risk ratio of the non17 prescription sunscreen condition; and 

18 ‘‘(D) the labeling of the nonprescription 

19 sunscreen condition. 

20 ‘‘(3) COMMUNICATIONS BETWEEN ADVISORY

21 COMMITTEE AND OTHER INDIVIDUALS WHO SUBMIT

22 DATA.—The advisory committee shall have the au23 thority to communicate with the sponsor and other 

24 individuals who submit data during the advisory 


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1 committee’s review, including requesting clarification 

2 or additional information. 

3 ‘‘(4) RECOMMENDATIONS.— 

4 ‘‘(A) IN GENERAL.—For each such sub5 mission under subsection (f)(3) or (g), the advi6 sory committee shall make one of the following 

7 recommendations to the Secretary: 

8 ‘‘(i) The sunscreen condition is gen9 erally recognized as safe and effective (in10 cluding any or all indications), including 

11 nonprescription sunscreen conditions for 

12 which a new drug application has been ap13 proved by the Secretary. 

14 ‘‘(ii) Insufficient information has been 

15 provided to support a recommendation that 

16 the sunscreen condition is generally recog17 nized as safe and effective (including any 

18 or all indications). 

19 ‘‘(iii) The sunscreen condition is not 

20 generally recognized as safe and effective 

21 to be marketed or sold, unless an applica22 tion with respect to such condition is ap23 proved under section 505(b). 

24 ‘‘(B) TIMING.—The advisory committee 

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1 graph (A) not later than 180 days after the ad2 visory committee receives the application and 

3 data submitted under subsection (f)(3) or sub4 section (g). 

5 ‘‘(C) RESUBMISSION OF DATA.—If the ad6 visory committee recommends that insufficient 

7 information has been provided, in accordance 

8 with subparagraph (A)(ii), the advisory com9 mittee shall make such recommendation not 

10 later than 180 days after the date on which 

11 such additional information is submitted. 

12 ‘‘(i) DETERMINATION BY THE CENTER FOR DRUG

13 EVALUATION AND RESEARCH.— 

14 ‘‘(1) IN GENERAL.—The Center for Drug Eval15 uation and Research shall respond to the rec16 ommendations of the advisory committee under sub17 section (h)(4) as follows: 

18 ‘‘(A) In the case of a recommendation by 

19 the advisory committee described in clause (i) 

20 of subsection (h)(4), not later than 45 days 

21 after the advisory committee issues the rec22 ommendation, the Center for Drug Evaluation 

23 and Research shall issue a determination af24 firming or denying the recommendation of the 

25 advisory committee. If the Center for Drug 


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1 Evaluation and Research affirms the rec2 ommendation of the advisory committee, or if 

3 the Center for Drug Evaluation and Research 

4 takes no action regarding the recommendation 

5 within 45 days of receiving such recommenda6 tion, the nonprescription sunscreen condition 

7 shall be generally recognized as safe and effec8 tive, not misbranded, and permitted to be mar9 keted and sold in accordance with all applicable 

10 rules and regulations for over-the-counter 

11 drugs. 

12 ‘‘(B) In the case of a recommendation de13 scribed in clause (ii) of such subsection, the 

14 Center for Drug Evaluation and Research shall 

15 issue a determination affirming or denying the 

16 recommendation of the advisory committee, to 

17 be made publicly available, within 45 days of 

18 receiving the recommendation, and inform the 

19 sponsor that the sponsor must submit addi20 tional information to the advisory committee in 

21 order to continue the review by the advisory 

22 committee. 

23 ‘‘(C) In the case of a recommendation de24 scribed in clause (iii) of such subsection, the 

25 Center for Drug Evaluation and Research shall 


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1 issue a determination affirming or denying the 

2 recommendation of the advisory committee, to 

3 be made publicly available, within 45 days of 

4 receiving such recommendation, and indicate 

5 whether such sunscreen condition determined to 

6 be not generally recognized as safe and effective 

7 to be marketed and sold, unless an application 

8 with respect to such condition is approved 

9 under section 505(b), or whether additional 

10 data must be submitted to the advisory com11 mittee. 

12 ‘‘(2) SUPERVISORY REVIEW OF DETERMINA13 TION.— 

14 ‘‘(A) IN GENERAL.—Any person may re15 quest a supervisory review of a determination of 

16 the Center for Drug Evaluation and Research 

17 to not accept a recommendation of an advisory 

18 committee. Such review may be conducted at 

19 the next supervisory or higher level above the 

20 individual who made the determination. 

21 ‘‘(B) REQUEST FOR SUPERVISORY RE22 VIEW.—A request described in subparagraph 

23 (A) shall be made to the Secretary not later 

24 than 30 days after such decision and shall indi25 cate in the request whether such person seeks 


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1 an in-person meeting or a teleconference. The 

2 Secretary shall schedule an in-person or tele3 conference review, if so requested, not later 

4 than 30 days after such request is made. The 

5 Secretary shall issue a decision to the person 

6 requesting a review under this paragraph not 

7 later than 45 days after the meeting. 

8 ‘‘(C) STANDARD OF SUPERVISORY RE9 VIEW.—The Secretary shall be authorized to 

10 overturn a determination of the Center for 

11 Drug Evaluation and Research not to accept a 

12 recommendation of the advisory committee if 

13 the supervisory review results in a decision by 

14 the reviewer that the individual who made the 

15 determination did not provide reasonable and 

16 sufficient substantive support for the decision 

17 to disregard the advisory committee’s rec18 ommendation. 

19 ‘‘(D) SUPERVISORY REVIEW DECISION.—If 

20 the Secretary overturns a determination by the 

21 Center for Drug Evaluation and Research not 

22 to accept a favorable recommendation of an ad23 visory committee, the nonprescription sunscreen 

24 condition shall be generally recognized as safe 

25 and effective, not misbranded, and permitted to 


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1 be marketed and sold in accordance with all ap2 plicable rules and regulations for over-the3 counter drugs. 

4 ‘‘(E) FINAL AGENCY ACTION.—A decision 

5 made through supervisory review shall con6 stitute final agency action subject to judicial re7 view. 

8 ‘‘(j) REPORTS.— 

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

10 the date of enactment of the Sunscreen Innovation 

11 Act, on March 1, 2015, and every 2 years thereafter, 

12 the Secretary shall issue a report to Congress de13 scribing actions taken under this section. 

14 ‘‘(2) CONTENTS.—The reports under paragraph 

15 (1) shall include— 

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

17 issuing in a timely manner decisions on the 

18 safety and effectiveness for sunscreen condi19 tions for applications pending as of the date of 

20 enactment of the Sunscreen Innovation Act, in21 cluding the number of pending applications— 

22 ‘‘(i) reviewed and the decision times 

23 for each application, measured from the 

24 date of original eligibility application sub25 mission by the sponsor; 


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1 ‘‘(ii) resulting in a determination of 

2 generally recognized as safe and effective 

3 and not misbranded; 

4 ‘‘(iii) resulting in a determination of 

5 not generally recognized as safe and effec6 tive and not misbranded and the reasons 

7 for such determinations; and 

8 ‘‘(iv) for which a determination has 

9 not been made, an explanation for the 

10 delay, a description of the current status of 

11 each such application, and the length of 

12 time such applications have been pending, 

13 measured from the date of original eligi14 bility application submission by the spon15 sor; 

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

17 issuing in a timely manner a decision on safety 

18 and effectiveness for sunscreen condition appli19 cations submitted after the date of enactment 

20 of the Sunscreen Innovation Act, including the 

21 number of such applications— 

22 ‘‘(i) reviewed and the decision times 

23 for each application; 


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1 ‘‘(ii) resulting in a determination of 

2 generally recognized as safe and effective 

3 and not misbranded; and 

4 ‘‘(iii) resulting in a determination of 

5 not generally recognized as safe and effec6 tive and not misbranded and the reasons 

7 for such determinations; 

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

10 review and decisionmaking pertaining to appli11 cations; 

12 ‘‘(D) a review of the progress in meeting 

13 the deadlines with respect to processing applica14 tions under this section; 

15 ‘‘(E) to the extent the Secretary deter16 mines appropriate, recommendations for process 

17 improvements in the handling of pending and 

18 new applications; and 

19 ‘‘(F) recommendations for expanding the 

20 applicability of this section to nonprescription 

21 active ingredients or conditions that are not re22 lated to the sunscreen category of over-the23 counter drugs. 

24 ‘‘(3) METHOD.—The Secretary shall publish the 

25 reports required under this subsection in the manner 


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1 the Secretary determines to be the most effective for 

2 efficiently disseminating the report, including publi3 cation of the report on the Internet website of the 

4 Food and Drug Administration. 

5 ‘‘(k) RULES OF CONSTRUCTION.— 

6 ‘‘(1) AUTHORITY TO WITHDRAW OR SUS7 PEND.—Nothing in this section shall be construed to 

8 alter the Secretary’s authority to withdraw or sus9 pend from the market a drug that the Secretary de10 termines to be unsafe or ineffective. 

11 ‘‘(2) OTHER CONDITIONS.—Nothing in the sec12 tion shall affect the Secretary’s authority to review 

13 nonprescription conditions other than sunscreen con14 ditions.’’. 

15 SEC. 3. SUNSCREEN TESTING AND LABELING. 

16 Not later than 180 days after the date of enactment 

17 of this Act, the Secretary shall issue determinations with 

18 respect to— 

19 (1) the appropriate testing and labeling require20 ments for sunscreens sold as an aerosol; and 

21 (2) whether sunscreen may contain a label indi22 cating a sun protection factor greater than 50. 

23 SECTION 1. SHORT TITLE. 

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

25 Act’’. 


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1 SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN 

2 ACTIVE INGREDIENTS. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 

5 by adding at the end the following: 

6 ‘‘Subchapter I—Nonprescription Sunscreen 

7 and Other Active Ingredients 

8 ‘‘SEC. 586. DEFINITIONS. 

9 ‘‘In this subchapter— 

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

11 Nonprescription Drug Advisory Committee of the 

12 Food and Drug Administration or any successor to 

13 such Committee; 

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

15 order published by the Secretary in the Federal Reg16 ister containing information stating that a non17 prescription sunscreen active ingredient or combina18 tion of nonprescription sunscreen active ingredients— 

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

20 marketed in accordance with such order; or 

21 ‘‘(B) is not GRASE and is misbranded; 

22 ‘‘(3) the term ‘GRASE’ means generally recog23 nized, among experts qualified by scientific training 

24 and experience to evaluate the safety and effectiveness 

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1 tions prescribed, recommended, or suggested in the la2 beling of a drug as described in section 201(p); 

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

4 with respect to a nonprescription active ingredient or 

5 a combination of nonprescription active ingredients, 

6 a determination of whether such ingredient or com7 bination of ingredients is GRASE; 

8 ‘‘(5) the term ‘nonprescription’ means not subject 

9 to section 503(b)(1); 

10 ‘‘(6) the term ‘pending request’ means each re11 quest with respect to a nonprescription sunscreen ac12 tive ingredient submitted under section 330.14 of title 

13 21, Code of Federal Regulations (as in effect on the 

14 date of enactment of the Sunscreen Innovation Act) 

15 for consideration for inclusion in the over-the-counter 

16 drug monograph system— 

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

18 such review by publication of a notice of eligi19 bility in the Federal Register prior to the date 

20 of enactment of such Act; and 

21 ‘‘(B) for which safety and effectiveness data 

22 have been submitted to the Secretary prior to 

23 such date of enactment; 

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

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1 lished by the Secretary in the Federal Register con2 taining information proposing that a nonprescription 

3 sunscreen active ingredient or combination of non4 prescription sunscreen active ingredients— 

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

6 marketed in accordance with such order; 

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

8 ‘‘(C) is not GRASE and is misbranded be9 cause the data are insufficient to classify such 

10 ingredient or combination of ingredients as 

11 GRASE and not misbranded and additional in12 formation is necessary to allow the Secretary to 

13 determine otherwise; 

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

15 submitted— 

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

17 ‘‘(B) a pending request; or 

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

19 subchapter; 

20 ‘‘(9) the term ‘sunscreen’ means a drug con21 taining one or more sunscreen active ingredients; and 

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

23 means an active ingredient that is intended for appli24 cation to the skin of humans for purposes of absorb25 ing, reflecting, or scattering ultraviolet radiation. 


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

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

3 for a determination of whether a nonprescription sunscreen 

4 active ingredient or a combination of nonprescription sun5 screen active ingredients, for use under specified conditions, 

6 to be prescribed, recommended, or suggested in the labeling 

7 thereof (including dosage form, dosage strength, and route 

8 of administration) is GRASE and should be included in 

9 part 352 of title 21, Code of Federal Regulations (or any 

10 successor regulations) concerning nonprescription sun11 screen. 

12 ‘‘SEC. 586B. ELIGIBILITY DETERMINATIONS; DATA SUBMIS13 SION; FILING. 

14 ‘‘(a) ELIGIBILITY DETERMINATIONS.— 

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

16 days after the date of receipt of a request under sec17 tion 586A, the Secretary shall— 

18 ‘‘(A) determine, in accordance with para19 graph (2), whether the request is eligible for fur20 ther review under subsection (b) and section 

21 586C; 

22 ‘‘(B) notify the sponsor of the determination 

23 of the Secretary; and 

24 ‘‘(C) make such determination publicly 

25 available in accordance with paragraph (3) and 

26 subsection (b)(1). 


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1 ‘‘(2) CRITERIA FOR ELIGIBILITY.— 

2 ‘‘(A) IN GENERAL.—To be eligible for review 

3 under subsection (b) and section 586C, a request 

4 shall be for a nonprescription sunscreen active 

5 ingredient or combination of nonprescription 

6 sunscreen active ingredients, for use under speci7 fied conditions, to be prescribed, recommended, 

8 or suggested in the labeling thereof, that— 

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

10 21, Code of Federal Regulations (or any 

11 successor regulations) concerning non12 prescription sunscreen; and 

13 ‘‘(ii) has been used to a material extent 

14 and for a material time under such condi15 tions, as described in section 201(p)(2). 

16 ‘‘(B) ESTABLISHMENT OF TIME AND EX17 TENT.—A sponsor shall include in a request 

18 under section 586A the information required 

19 under section 330.14 of title 21, Code of Federal 

20 Regulations (or any successor regulations) to 

21 meet the standard described in subparagraph 

22 (A)(ii). 

23 ‘‘(3) PUBLIC AVAILABILITY.— 

24 ‘‘(A) REDACTIONS FOR CONFIDENTIAL IN25 FORMATION.—If a nonprescription sunscreen acVerDate Sep 11 2014 23:00 Sep 17, 2014 Jkt 039200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6203 E:\BILLS\S2141.RS S2141

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1 tive ingredient or combination of nonprescrip2 tion sunscreen active ingredients is determined 

3 under paragraph (1)(A) to be eligible for further 

4 review, the Secretary shall make the request pub5 licly available, with redactions for information 

6 that is treated as confidential under section 

7 552(b) of title 5, United States Code, section 

8 1905 of title 18, United States Code, or section 

9 301(j) of this Act. 

10 ‘‘(B) IDENTIFICATION OF CONFIDENTIAL IN11 FORMATION BY SPONSOR.—At the time that a re12 quest is made under section 586A, the sponsor of 

13 such request shall identify any information that 

14 such sponsor considers to be confidential infor15 mation described in subparagraph (A). 

16 ‘‘(C) CONFIDENTIALITY DURING ELIGIBILITY

17 REVIEW.—The information contained in a re18 quest under section 586A shall remain confiden19 tial during the Secretary’s consideration under 

20 this section of whether the request is eligible for 

21 further review consistent with section 330.14 of 

22 title 21, Code of Federal Regulations (or any 

23 successor regulations). 

24 ‘‘(b) DATA SUBMISSION AND FILING OF REQUESTS.— 


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

2 under section 586A that is determined to be eligible 

3 under subsection (a) for further review under this sec4 tion and section 586C, the Secretary shall, in noti5 fying the public under subsection (a)(1)(C) of such 

6 eligibility determination, post the eligibility deter7 mination on the Internet website of the Food and 

8 Drug Administration, invite the sponsor of such re9 quest and any other interested party to submit com10 ments, and provide a period of not less than 45 cal11 endar days for comments in support of or otherwise 

12 relating to a GRASE determination, including pub13 lished and unpublished data and other information 

14 related to the safety and efficacy of such request. 

15 ‘‘(2) FILING DETERMINATION.—Not later than 60 

16 calendar days after the submission of data and other 

17 information described in paragraph (1) by the spon18 sor, the Secretary shall determine whether the data 

19 and other information submitted by the sponsor under 

20 this section are sufficiently complete, including being 

21 formatted in a manner that enables the Secretary to 

22 determine the completeness of such data and informa23 tion, to enable the Secretary to conduct a substantive 

24 review under section 586C with respect to such re25 quest. Not later than 60 calendar days after the subVerDate Sep 11 2014 23:00 Sep 17, 2014 Jkt 039200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6203 E:\BILLS\S2141.RS S2141

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1 mission of data and other information described in 

2 paragraph (1) by the sponsor, if the Secretary deter3 mines— 

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

5 are sufficiently complete, the Secretary shall— 

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

7 sponsor of the determination to file such re8 quest, and make such notification publicly 

9 available; and 

10 ‘‘(ii) file such request made under sec11 tion 586A; or 

12 ‘‘(B) that such data and other information 

13 are not sufficiently complete, the Secretary shall 

14 issue a written notification to the sponsor of the 

15 determination to refuse to file the request, which 

16 shall include the reasons for the refusal, includ17 ing why such data and other information are 

18 not sufficiently complete, and make such notifi19 cation publicly available. 

20 ‘‘(3) REFUSAL TO FILE A REQUEST.— 

21 ‘‘(A) REQUEST FOR MEETINGS; SUBMISSION

22 OF ADDITIONAL DATA OR OTHER INFORMA23 TION.—If the Secretary refuses to file a request 

24 made under section 586A, the sponsor may— 


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

2 of written notification of such refusal, re3 quest, in writing, a meeting with the Sec4 retary regarding the filing determination; 

5 and 

6 ‘‘(ii) submit additional data or other 

7 information. 

8 ‘‘(B) MEETINGS.— 

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

10 meeting under subparagraph (A)(i), the 

11 Secretary shall convene the meeting within 

12 30 calendar days of the request for such 

13 meeting. 

14 ‘‘(ii) ACTIONS AFTER MEETING.—Fol15 lowing any meeting held under clause (i)— 

16 ‘‘(I) the Secretary may file the re17 quest within 60 calendar days; 

18 ‘‘(II) the sponsor may submit ad19 ditional data or other information; or 

20 ‘‘(III) if the sponsor elects, within 

21 120 calendar days, to have the Sec22 retary file the request (with or without 

23 amendments to correct any purported 

24 deficiencies to the request)— 


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1 ‘‘(aa) the Secretary shall file 

2 the request over protest, not later 

3 than 30 calendar days after the 

4 sponsor makes such election; 

5 ‘‘(bb) at the time of filing, 

6 the Secretary shall provide writ7 ten notification of such filing to 

8 the sponsor; and 

9 ‘‘(cc) the Secretary shall 

10 make such notification publicly 

11 available. 

12 ‘‘(iii) REQUESTS FILED OVER PRO13 TEST.—The Secretary shall not require the 

14 sponsor to resubmit a copy of the request for 

15 purposes of filing a request filed over pro16 test, as described in clause (ii)(III). 

17 ‘‘(C) SUBMISSIONS OF ADDITIONAL DATA OR

18 OTHER INFORMATION.—Within 60 calendar days 

19 of any submission of additional data or other in20 formation under subparagraph (A)(ii) or 

21 (B)(ii)(II), the Secretary shall reconsider the 

22 previous determination made under paragraph 

23 (2) with respect to the applicable request and 

24 make a new determination in accordance with 

25 paragraph (2). 


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1 ‘‘(4) PUBLIC AVAILABILITY.— 

2 ‘‘(A) REDACTIONS FOR CONFIDENTIAL IN3 FORMATION.—After the period of confidentiality 

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

5 shall make data and other information submitted 

6 in connection with a request under section 586A 

7 publicly available, with redactions for informa8 tion that is treated as confidential under section 

9 552(b) of title 5, United States Code, section 

10 1905 of title 18, United States Code, or section 

11 301(j) of this Act. 

12 ‘‘(B) IDENTIFICATION OF CONFIDENTIAL IN13 FORMATION BY SPONSOR.—A person submitting 

14 information under this section shall identify at 

15 the time of such submission the portions of such 

16 information that the person considers to be con17 fidential information described in subparagraph 

18 (A). 

19 ‘‘SEC. 586C. GRASE DETERMINATION. 

20 ‘‘(a) REVIEW OF NEW REQUEST.— 

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

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

23 300 calendar days after the date on which such re24 quest is filed under subsection (b)(2)(A) or 

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


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1 ‘‘(A) may convene a meeting of the Advisory 

2 Committee to review such request; and 

3 ‘‘(B) shall complete the review of such re4 quest and issue a proposed sunscreen order with 

5 respect to such request. 

6 ‘‘(2) PROPOSED SUNSCREEN ORDER BY COMMIS7 SIONER.—If the Secretary does not issue a proposed 

8 sunscreen order under paragraph (1)(B) within such 

9 300-day period, the sponsor of such request may no10 tify the Office of the Commissioner of such request 

11 and request review by the Office of the Commissioner. 

12 If such sponsor so notifies the Office of the Commis13 sioner, the Commissioner shall, not later than 60 cal14 endar days after the date of notification under this 

15 paragraph, issue a proposed sunscreen order with re16 spect to such request. 

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

18 sunscreen order issued under paragraph (1)(B) or (2) 

19 with respect to a request shall provide for a period of 

20 45 calendar days for public comment. 

21 ‘‘(4) MEETING.—A sponsor may request, in writ22 ing, a meeting with respect to a proposed sunscreen 

23 order issued under this subsection and described in 

24 subparagraph (B) or (C) of section 586(7), not later 

25 than 30 calendar days after the Secretary issues such 


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1 order. The Secretary shall convene a meeting with 

2 such sponsor not later than 45 calendar days after 

3 such request for a meeting. 

4 ‘‘(5) FINAL SUNSCREEN ORDER.—With respect to 

5 a proposed sunscreen order under paragraph (1)(B) 

6 or (2)— 

7 ‘‘(A) the Secretary shall issue a final sun8 screen order— 

9 ‘‘(i) in the case of a proposed sunscreen 

10 order described in subparagraph (A) or (B) 

11 of section 586(7), not later than 90 calendar 

12 days after the end of the public comment 

13 period under paragraph (3); or 

14 ‘‘(ii) in the case of a proposed sun15 screen order described in subparagraph (C) 

16 of section 586(7), not later than 210 cal17 endar days after the date on which the 

18 sponsor submits the additional information 

19 requested pursuant to such proposed sun20 screen order; or 

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

22 final sunscreen order within such 90- or 210-cal23 endar-day period, as applicable, the sponsor of 

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1 missioner of such request and request review by 

2 the Office of the Commissioner. 

3 ‘‘(6) FINAL SUNSCREEN ORDER BY COMMIS4 SIONER.—The Commissioner shall issue a final sun5 screen order with respect to a proposed sunscreen 

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

7 calendar days after the date of notification under 

8 such paragraph. 

9 ‘‘(b) REVIEW OF PENDING REQUESTS.— 

10 ‘‘(1) IN GENERAL.—The review of a pending re11 quest shall be carried out by the Secretary in accord12 ance with this subsection. 

13 ‘‘(2) INAPPLICABILITY OF SECTIONS 586A AND

14 586B.—Sections 586A and 586B shall not apply with 

15 respect to any pending request. 

16 ‘‘(3) FEEDBACK LETTERS AS PROPOSED SUN17 SCREEN ORDER.—Notwithstanding the requirements 

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

19 330.14(g) of title 21, Code of Federal Regulations be20 fore the date of enactment of the Sunscreen Innova21 tion Act, with respect to a pending request, shall be 

22 deemed to be a proposed sunscreen order and dis23 played on the Internet website of the Food and Drug 

24 Administration. Notification of the availability of 

25 such letter shall be published in the Federal Register 


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1 not later than 45 calendar days after the date of en2 actment of such Act. 

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

4 case of a pending request for which the Secretary has 

5 not issued a letter pursuant to section 330.14(g) of 

6 title 21, Code of Federal Regulations before the date 

7 of enactment of the Sunscreen Innovation Act, the 

8 Secretary shall complete review of such request and, 

9 not later than 90 calendar days after the date of en10 actment of such Act, issue a proposed sunscreen order 

11 with respect to such request. 

12 ‘‘(5) PROPOSED SUNSCREEN ORDER BY COMMIS13 SIONER.—If the Secretary does not issue a proposed 

14 sunscreen order under paragraph (4), or the Secretary 

15 does not publish a notification of the availability of 

16 a letter under paragraph (3), as applicable, the spon17 sor of such request may notify the Office of the Com18 missioner of such request and request review by the 

19 Office of the Commissioner. The Commissioner shall, 

20 not later than 60 calendar days after the date of noti21 fication under this paragraph, issue a proposed order 

22 with respect to such request. 

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

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

25 a notification of the availability of a letter under 


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1 paragraph (3), with respect to a pending request shall 

2 provide for a period of 45 calendar days for public 

3 comment. 

4 ‘‘(7) MEETING.—A sponsor may request, in writ5 ing, a meeting with respect to a proposed sunscreen 

6 order issued under this subsection, including a letter 

7 deemed to be a proposed sunscreen order under para8 graph (3), not later than 30 calendar days after the 

9 Secretary issues such order or the date upon which 

10 such feedback letter is deemed to be a proposed sun11 screen order, as applicable. The Secretary shall con12 vene a meeting with such sponsor not later than 45 

13 calendar days after the date of such request for a 

14 meeting. 

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

16 proposed sunscreen order under paragraph (3), (4), or 

17 (5), an Advisory Committee meeting may be convened 

18 for the purpose of reviewing and providing rec19 ommendations regarding the pending request. 

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

21 a proposed sunscreen order under paragraph (3), (4), 

22 or (5)— 

23 ‘‘(A) the Secretary shall issue a final sun24 screen order with respect to the request— 


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1 ‘‘(i) in the case of a proposed sunscreen 

2 order described in subparagraph (A) or (B) 

3 of section 586(7), not later than 90 calendar 

4 days after the end of the public comment 

5 period under paragraph (6); or 

6 ‘‘(ii) in the case of a proposed sun7 screen order described in subparagraph (C) 

8 of section 586(7)— 

9 ‘‘(I) if the Advisory Committee is 

10 not convened under paragraph (8), not 

11 later than 210 calendar days after the 

12 date on which the sponsor submits the 

13 additional information requested pur14 suant to such proposed sunscreen order, 

15 which shall include a rationale for not 

16 convening such Advisory Committee; or 

17 ‘‘(II) if the Advisory Committee is 

18 convened under paragraph (8), not 

19 later than 270 calendar days after the 

20 date on which the sponsor submits such 

21 additional information; or 

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

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

24 270-calendar-day period, as applicable, the spon25 sor of such request may notify the Office of the 


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1 Commissioner about such request and request re2 view by the Office of the Commissioner. 

3 ‘‘(10) FINAL SUNSCREEN ORDER BY COMMIS4 SIONER.—The Commissioner shall issue a final sun5 screen order with respect to a proposed sunscreen 

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

7 calendar days after the date of notification under 

8 such paragraph. 

9 ‘‘(c) ADVISORY COMMITTEE.—The Secretary shall not 

10 be required to— 

11 ‘‘(1) convene the Advisory Committee— 

12 ‘‘(A) more than once with respect to any re13 quest under section 586A or any pending re14 quest; or 

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

16 with respect to the review under this section; or 

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

18 under section 586A or pending requests to the Advi19 sory Committee per meeting. 

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

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

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

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

24 ‘‘(1) IN GENERAL.— 


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1 ‘‘(A) SUNSCREEN ACTIVE INGREDIENTS DE2 TERMINED TO BE GRASE.—Upon issuance of a 

3 final sunscreen order determining that a non4 prescription sunscreen active ingredient or com5 bination of nonprescription sunscreen active in6 gredients is GRASE and is not misbranded, a 

7 sunscreen containing such ingredient or com8 bination of ingredients shall be permitted to be 

9 introduced or delivered into interstate commerce 

10 for use under the conditions described in such 

11 final sunscreen order, in accordance with all re12 quirements applicable to drugs not subject to sec13 tion 503(b)(1), for so long as such final sun14 screen order remains in effect. 

15 ‘‘(B) SUNSCREEN ACTIVE INGREDIENTS DE16 TERMINED NOT TO BE GRASE.—Upon issuance of 

17 a final sunscreen order determining that a non18 prescription sunscreen active ingredient or com19 bination of nonprescription sunscreen active in20 gredients is not GRASE and is misbranded, a 

21 sunscreen containing such ingredient or com22 bination of ingredients shall not be introduced or 

23 delivered into interstate commerce, for use under 

24 the conditions described in such final sunscreen 

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1 ant to section 505 with respect to a sunscreen 

2 containing such ingredient or combination of in3 gredients, or unless conditions are later estab4 lished under which such ingredient or combina5 tion of ingredients is later determined to be 

6 GRASE and not misbranded under the over-the7 counter drug monograph system. 

8 ‘‘(2) AMENDMENTS TO FINAL SUNSCREEN OR9 DERS.— 

10 ‘‘(A) AMENDMENTS AT INITIATIVE OF SEC11 RETARY.—In the event that information relevant 

12 to a nonprescription sunscreen active ingredient 

13 or combination of nonprescription sunscreen ac14 tive ingredients becomes available to the Sec15 retary after issuance of a final sunscreen order, 

16 the Secretary may amend such final sunscreen 

17 order by issuing a new proposed sunscreen order 

18 under subsection (a)(1) and following the proce19 dures set forth in this section. 

20 ‘‘(B) PETITION TO AMEND FINAL ORDER.— 

21 Any interested person may petition the Secretary 

22 to amend a final sunscreen order under section 

23 10.30, title 21 Code of Federal Regulations (or 

24 any successor regulations). If the Secretary 

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1 retary shall initiate the process for amending a 

2 final sunscreen order by issuing a new proposed 

3 sunscreen order under subsection (a)(1) and fol4 lowing the procedures set forth in this section. 

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

6 Once the Secretary issues a new proposed sun7 screen order to amend a final sunscreen order 

8 under subparagraph (A) or (B), such final sun9 screen order shall remain in effect and para10 graph (3) shall not apply to such final sunscreen 

11 order until the Secretary has issued a new final 

12 sunscreen order or has determined not to amend 

13 the final sunscreen order. 

14 ‘‘(3) INCLUSION OF INGREDIENTS THAT ARE

15 SUBJECTS OF FINAL ORDERS IN THE SUNSCREEN

16 MONOGRAPH.— 

17 ‘‘(A) AMENDING REGULATIONS.— 

18 ‘‘(i) REQUIREMENT.—At any time that 

19 the Secretary proposes to amend part 352 of 

20 title 21, Code of Federal Regulations (or 

21 any successor regulations) concerning non22 prescription sunscreen, including pursuant 

23 to section 586E, except as provided in 

24 clause (iv), the Secretary shall include in 

25 such part 352 (or any successor regulations) 


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1 any nonprescription sunscreen active ingre2 dient or combination of nonprescription 

3 sunscreen active ingredients that is the sub4 ject of an effective final sunscreen order of 

5 the type described in section 586(2)(A) and 

6 issued since the time that the Secretary last 

7 amended such regulations. Such regulation 

8 shall set forth conditions of use under which 

9 each such ingredient or combination of in10 gredients is GRASE and not misbranded. If 

11 these conditions differ from, or are in addi12 tion to, those previously set forth in the ap13 plicable final sunscreen order, the Secretary 

14 shall provide notice and opportunity for 

15 comment on such conditions in the rule16 making, and the applicable final sunscreen 

17 order shall continue in effect until the effec18 tive date of a final regulation, as set forth 

19 in clause (iii). 

20 ‘‘(ii) INCLUSION OF ORDERS.—In pro21 posing to amend the regulations as de22 scribed in clause (i), the Secretary shall in23 clude in the proposed regulations a list of 

24 final sunscreen orders that shall cease to be 

25 effective on the effective date of a resulting 


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1 final regulation. Such list shall include all 

2 final sunscreen orders of the type described 

3 in section 586(2)(A) that are in effect on the 

4 date that such regulations are proposed, 

5 with the exception that such list shall not 

6 include any final sunscreen orders that, on 

7 the date that the regulations are proposed, 

8 the Secretary is in the process of amending 

9 under paragraph (2). 

10 ‘‘(iii) ORDERS NO LONGER EFFEC11 TIVE.—Any final sunscreen order included 

12 by the Secretary in a list described in 

13 clause (ii) and in a list included in result14 ing final regulations shall cease to be effec15 tive on the date that such final regulations 

16 including such order in such list become ef17 fective. 

18 ‘‘(iv) INGREDIENTS NOT GRASE.—If, 

19 notwithstanding a final sunscreen order 

20 stating that a nonprescription sunscreen ac21 tive ingredient or combination of non22 prescription sunscreen active ingredients is 

23 GRASE and is not misbranded if marketed 

24 in accordance with such order, while 

25 amending the regulations as described in 


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1 clause (i), the Secretary concludes that such 

2 ingredient or combination of ingredients is 

3 no longer GRASE for use in nonprescrip4 tion sunscreen, the Secretary shall, at the 

5 discretion of the Secretary, either initiate 

6 the process for amending the final sunscreen 

7 order set forth in paragraph (2) of this sub8 section or include in a proposed regulation 

9 an explanation and information supporting 

10 the determination of the Secretary that such 

11 ingredient or combination of ingredients is 

12 no longer GRASE for use in nonprescrip13 tion sunscreen. 

14 ‘‘(B) PROCEDURE FOR UPDATING REGULA15 TIONS.—After the Secretary amends and final16 izes the regulations under part 352 of title 21, 

17 Code of Federal Regulations under section 586E 

18 and such regulations become effective, the Sec19 retary may use direct final rulemaking to in20 clude in such regulations any nonprescription 

21 sunscreen active ingredients that are the subject 

22 of effective final sunscreen orders. 

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

24 ‘‘(a) GUIDANCE.— 

25 ‘‘(1) IN GENERAL.— 


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

2 year after the date of enactment of the Sunscreen 

3 Innovation Act, the Secretary shall issue draft 

4 guidance on the implementation of, and compli5 ance with, the requirements with respect to sun6 screen under this subchapter, including guidance 

7 on— 

8 ‘‘(i) the format and content of informa9 tion submitted by a sponsor in support of 

10 a request under section 586A or a pending 

11 request; 

12 ‘‘(ii) the data required to meet the safe13 ty and efficacy standard for determining 

14 whether a nonprescription sunscreen active 

15 ingredient or combination of nonprescrip16 tion sunscreen active ingredients is GRASE 

17 and is not misbranded; 

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

19 under section 586A or a pending request is 

20 withdrawn; and 

21 ‘‘(iv) the process by which the Sec22 retary will carry out section 586C(c), in23 cluding with respect to how the Secretary 

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1 ceived under section 586A and pending re2 quests. 

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

4 shall finalize the guidance described in subpara5 graph (A) not later than 2 years after the date 

6 of enactment of the Sunscreen Innovation Act. 

7 ‘‘(C) INAPPLICABILITY OF PAPERWORK RE8 DUCTION ACT.—Chapter 35 of title 44, United 

9 States Code shall not apply to collections of in10 formation made for purposes of guidance under 

11 this subsection. 

12 ‘‘(2) SUBMISSIONS PENDING ISSUANCE OF FINAL

13 GUIDANCE.—Irrespective of whether final guidance 

14 under paragraph (1) has been issued— 

15 ‘‘(A) persons may, beginning on the date of 

16 enactment of the Sunscreen Innovation Act, 

17 make submissions under this subchapter; and 

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

19 upon such submissions in accordance with this 

20 subchapter. 

21 ‘‘(b) RULES OF CONSTRUCTION.— 

22 ‘‘(1) CURRENTLY MARKETED SUNSCREENS.— 

23 Nothing in this subchapter shall be construed to affect 

24 the marketing of sunscreens that are marketed in 

25 interstate commerce on or before the date of enactment 


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1 of this subchapter, except as otherwise provided in 

2 this subchapter. 

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

4 Nothing in this subchapter shall be construed to alter 

5 the authority of the Secretary with respect to prohib6 iting the marketing of a sunscreen that is not safe 

7 and effective or is misbranded, or with respect to im8 posing restrictions on the marketing of a sunscreen to 

9 ensure safety and effectiveness, except as otherwise 

10 provided in this subchapter, including section 

11 586C(e). 

12 ‘‘(3) OTHER DRUGS.—Except as otherwise pro13 vided in section 586F, nothing in this subchapter 

14 shall be construed to affect the authority of the Sec15 retary under this Act or the Public Health Service 

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

17 other than a nonprescription sunscreen. 

18 ‘‘(4) EFFECT ON DRUGS OTHERWISE AP19 PROVED.—Nothing in this subchapter shall affect the 

20 marketing of a drug approved under section 505 of 

21 this Act or section 351 of the Public Health Service 

22 Act. 

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

24 procedures under paragraphs (1), (2), (5), and (6) of section 

25 586C(a) shall not apply to any requests submitted to the 


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1 Secretary under section 586A after the date that is 6 years 

2 after the date of enactment of the Sunscreen Innovation Act. 

3 ‘‘SEC. 586E. SUNSCREEN MONOGRAPH. 

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

5 date of enactment of the Sunscreen Innovation Act, the Sec6 retary shall amend and finalize regulations under part 352 

7 of title 21, Code of Federal Regulations concerning non8 prescription sunscreen that are effective not later than 5 

9 years after such date of enactment. The Secretary shall pub10 lish such regulations not less than 30 calendar days before 

11 the effective date of such regulations. 

12 ‘‘(b) REPORTS.—If the regulations promulgated under 

13 subsection (a) do not include provisions related to the effec14 tiveness of various sun protection factor levels, and do not 

15 address all dosage forms known to the Secretary to be used 

16 in sunscreens marketed in the United States without a new 

17 drug approval under section 505, the Secretary shall submit 

18 a report to the Committee on Health, Education, Labor, 

19 and Pensions of the Senate and the Committee on Energy 

20 and Commerce of the House of Representatives on the ra21 tionale for such provisions not being included in such regu22 lations, and a plan and timeline to compile any informa23 tion necessary to address such provisions through final reg24 ulations.’’. 


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

2 amendment made by this section shall be construed to— 

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

4 section 586(8) of the Federal Food, Drug, and Cos5 metic Act, as added by subsection (a)) to request that 

6 the Secretary of Health and Human Services convene 

7 an advisory committee; or 

8 (2) limit the authority of the Secretary of Health 

9 and Human Services to meet with a sponsor (as de10 fined in section 586(8) of the Federal Food, Drug, 

11 and Cosmetic Act, as added by subsection (a)). 

12 SEC. 3. NON-SUNSCREEN TIME AND EXTENT APPLICA13 TIONS. 

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

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

16 adding at the end the following: 

17 ‘‘SEC. 586F. NON-SUNSCREEN TIME AND EXTENT APPLICA18 TIONS. 

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

20 ‘‘(1) IN GENERAL.— 

21 ‘‘(A) REQUEST FOR FRAMEWORK FOR RE22 VIEW.—If, prior to the date of enactment of the 

23 Sunscreen Innovation Act, an application was 

24 submitted pursuant to section 330.14 of title 21, 

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1 mination for a drug other than a nonprescrip2 tion sunscreen active ingredient or combination 

3 of nonprescription sunscreen active ingredients 

4 and such drug was found to be eligible to be con5 sidered for inclusion in the over-the-counter drug 

6 monograph system pursuant to section 330.14 of 

7 title 21, Code of Federal Regulations, the sponsor 

8 of such application may request that the Sec9 retary provide a framework under paragraph (2) 

10 for the review of such application. 

11 ‘‘(B) REQUEST REQUIREMENTS.—A request 

12 for a framework for review of an application 

13 made under subparagraph (A) shall be made 

14 within 180 calendar days of the date of enact15 ment of the Sunscreen Innovation Act and shall 

16 include the preference of such sponsor as to 

17 whether such application is reviewed by the Sec18 retary in accordance with— 

19 ‘‘(i) the processes and procedures set 

20 forth for pending requests under section 

21 586C(b), except that specific timelines shall 

22 be determined in accordance with other ap23 plicable requirements under this section; 

24 ‘‘(ii) the processes and procedures set 

25 forth under part 330 of title 21, Code of 


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1 Federal Regulations (or any successor regu2 lations); 

3 ‘‘(iii) an initial filing determination 

4 under the processes and procedures de5 scribed in section 586B(b) and the processes 

6 and procedures set forth for pending re7 quests under section 586C(b), except that 

8 specific timelines shall be determined in ac9 cordance with other applicable requirements 

10 under this section; or 

11 ‘‘(iv) an initial filing determination 

12 under the processes and procedures de13 scribed in section 586B(b) and the processes 

14 and procedures set forth under part 330 of 

15 title 21, Code of Federal Regulations (or 

16 any successor regulations). 

17 ‘‘(C) NO REQUEST.—If a sponsor described 

18 in subparagraph (A) does not make such request 

19 within 180 calendar days of the date of enact20 ment of the Sunscreen Innovation Act, such ap21 plication shall be reviewed by the Secretary in 

22 accordance with the timelines of the applicable 

23 regulations when such regulations are finalized 

24 under subsection (b). 


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

2 the date of enactment of the Sunscreen Innovation 

3 Act, the Secretary shall provide, in writing, a frame4 work to each sponsor that submitted a request under 

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

6 various timelines, in calendar days, with respect to 

7 the processes and procedures for review under clauses 

8 (i), (ii), (iii), and (iv) of paragraph (1)(B) and— 

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

10 considerations under paragraph (5); and 

11 ‘‘(B) the timelines for the various processes 

12 and procedures shall not be shorter than the 

13 timelines set forth for pending requests under 

14 sections 586B(b) and 586C(b), as applicable. 

15 ‘‘(3) GOVERNING PROCESSES AND PROCEDURES

16 FOR REVIEW.— 

17 ‘‘(A) ELECTION.—Not later than 60 cal18 endar days after the Secretary provides a frame19 work to a sponsor under paragraph (2), such 

20 sponsor may provide an election to the Secretary 

21 regarding the processes and procedures for review 

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

23 (1)(B). If such sponsor makes such election, the 

24 Secretary shall review the application that is the 

25 subject of such election pursuant to the processes 


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1 and procedures elected by such sponsor and the 

2 applicable timelines in calendar days set forth 

3 under such framework, which the Secretary shall 

4 confirm in writing to the sponsor not later than 

5 the date upon which the Secretary provides a re6 port under paragraph (4). If such sponsor does 

7 not make such election, such application shall be 

8 reviewed by the Secretary in accordance with the 

9 timelines of the applicable regulations when such 

10 regulations are finalized under subsection (b). 

11 ‘‘(B) DIFFERENT PROCESSES AND PROCE12 DURES.—At any time during review of an appli13 cation, the Secretary may review such applica14 tion under different processes and procedures 

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

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

17 sponsor elected in accordance with subparagraph 

18 (A), so long as the Secretary proposes, in writ19 ing, the change and the sponsor agrees, in writ20 ing, to such change. 

21 ‘‘(C) INCLUSION OF INGREDIENTS IN MONO22 GRAPHS.—If the sponsor elects to use the proc23 esses and procedures for review in accordance 

24 with clause (i) or (iii) of paragraph (1)(B), the 

25 Secretary may incorporate any resulting final 


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1 order into a regulation addressing the conditions 

2 under which other drugs in the same therapeutic 

3 category are GRASE and not misbranded, in4 cluding through direct final rulemaking, and the 

5 final order so incorporated shall cease to be effec6 tive on the effective date of the final regulation 

7 that addresses such drug. 

8 ‘‘(4) LETTER REGARDING PENDING APPLICA9 TIONS.—Not later than 18 months after the date of 

10 enactment of the Sunscreen Innovation Act, the Sec11 retary shall report to the Committee on Health, Edu12 cation, Labor, and Pensions of the Senate and the 

13 Committee on Energy and Commerce of the House of 

14 Representatives, in writing, regarding all pending 

15 applications subject to paragraph (1). In such letter, 

16 the Secretary shall provide a report on the review of 

17 such applications, including the timelines, in cal18 endar days, for the review and GRASE determination 

19 for each application. Such timelines shall account for 

20 the considerations under paragraph (5). 

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

22 days established by the Secretary pursuant to this 

23 subsection— 


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1 ‘‘(A) may vary based on the content, com2 plexity, and format of the application submitted 

3 to the Secretary; and 

4 ‘‘(B) shall— 

5 ‘‘(i) reflect the public health priorities 

6 of the Food and Drug Administration, in7 cluding the potential public health benefits 

8 posed by the inclusion of additional drugs 

9 in the over-the-counter drug monograph sys10 tem; 

11 ‘‘(ii) take into consideration the re12 sources available to the Secretary for car13 rying out such priorities and the processes 

14 and procedures described in paragraphs 

15 (1)(B) and (2); and 

16 ‘‘(iii) be reasonable, taking into consid17 eration the requirements described in 

18 clauses (i) and (ii). 

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

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

21 after the date of enactment of the Sunscreen Innova22 tion Act, the Secretary shall issue proposed regula23 tions establishing timelines for the review of applica24 tions for GRASE determinations for drugs other than 

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1 binations of nonprescription sunscreen active ingredi2 ents that are submitted to the Secretary after the date 

3 of enactment of the Sunscreen Innovation Act, under 

4 section 330.14 of title 21, Code of Federal Regulations 

5 (or any successor regulations), and that are found to 

6 be eligible to be considered for inclusion in the over7 the-counter drug monograph system pursuant to sec8 tion 330.14 of title 21, Code of Federal Regulations 

9 (or any successor regulations), or that are subject to 

10 this subsection pursuant to paragraph (1) or (3) of 

11 subsection (a), as applicable, providing— 

12 ‘‘(A) timely and efficient completion of eval13 uations of applications under section 330.14 of 

14 title 21, Code of Federal Regulations (or any 

15 successor regulations) for drugs other than sun16 screens; and 

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

18 review of the safety and effectiveness submissions 

19 pursuant to such applications, including estab20 lishing— 

21 ‘‘(i) reasonable timelines, in calendar 

22 days, for the applicable proposed and final 

23 regulations for applications of various con24 tent, complexity, and format, and timelines 


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1 for internal procedures related to such proc2 esses; and 

3 ‘‘(ii) measurable metrics for tracking 

4 the extent to which the timelines set forth in 

5 the regulations are met. 

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

7 days established in the regulations under paragraph 

8 (1)— 

9 ‘‘(A) may vary based on the content, com10 plexity, and format of the application submitted 

11 to the Secretary; and 

12 ‘‘(B) shall— 

13 ‘‘(i) reflect the public health priorities 

14 of the Food and Drug Administration, in15 cluding the potential public health benefits 

16 posed by the inclusion of additional drugs 

17 in the over-the-counter drug monograph sys18 tem; 

19 ‘‘(ii) take into consideration the re20 sources available to the Secretary for car21 rying out such priorities and the processes 

22 and procedures described in paragraph (1); 

23 and 


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1 ‘‘(iii) be reasonable, taking into consid2 eration the requirements described in 

3 clauses (i) and (ii). 

4 ‘‘(3) PROCEDURE.—In promulgating regulations 

5 under this subsection, the Secretary shall issue a no6 tice of proposed rulemaking that includes a copy of 

7 the proposed regulation, provide a period of not less 

8 than 60 calendar days for comments on the proposed 

9 regulation, and publish the final regulation not less 

10 than 30 calendar days before the effective date of the 

11 regulation. 

12 ‘‘(4) RESTRICTIONS.—Notwithstanding any other 

13 provision of law, the Secretary shall promulgate regu14 lations implementing this section only as described in 

15 paragraphs (1), (2), and (3). 

16 ‘‘(5) FINAL REGULATIONS.—The Secretary shall 

17 finalize the regulations under this section not later 

18 than 27 months after the date of enactment of the 

19 Sunscreen Innovation Act.’’. 

20 SEC. 4. REPORTS. 

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

22 after the date of enactment of this Act, the Comptroller Gen23 eral of the United States shall submit to the Committee on 

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

25 the Committee on Energy and Commerce of the House of 


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1 Representatives a report reviewing the overall progress of 

2 the Secretary of Health and Human Services in carrying 

3 out subchapter I of chapter V of the Federal Food, Drug, 

4 and Cosmetic Act (as added by section 2 and amended by 

5 section 3 and subsection (c)), including findings on and rec6 ommendations with respect to— 

7 (1) the progress made in completing the review 

8 of requests under subchapter I of chapter V of the 

9 Federal Food, Drug, and Cosmetic Act, including 

10 pending requests, and the feasibility of the timelines 

11 associated with such subchapter; 

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

13 Food and Drugs in issuing determinations with re14 spect to requests reviewed under such subchapter, in15 cluding the number of requests transferred to the Of16 fice of the Commissioner under section 586C of such 

17 Act; 

18 (3) the extent to which advisory committees were 

19 convened by the Secretary regarding requests under 

20 subchapter I of chapter V of the Federal Food, Drug, 

21 and Cosmetic Act, including pending requests; and 

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

23 be, established for the review of time and extent appli24 cations. 


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(b) SUBSEQUENT GAO REPORT.—Not later than 51 1 ⁄2

2 years after the date of enactment of this Act, the Comp3 troller General of the United States shall submit to the Com4 mittee on Health, Education, Labor, and Pensions of the 

5 Senate and the Committee on Energy and Commerce of the 

6 House of Representatives a report reviewing the overall 

7 progress of the Secretary of Health and Human Services 

8 in carrying out subchapter I of chapter V of the Federal 

9 Food, Drug, and Cosmetic Act (as added by section 2 and 

10 amended by section 3 and subsection (c)) and the regulation 

11 of over-the-counter drug products, including findings on 

12 and recommendations with respect to— 

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

14 Comptroller General under subsection (a); 

15 (2) significant factors impacting the ability of 

16 the Food and Drug Administration to fulfill the mis17 sion of the agency with regard to the regulation of 

18 over-the-counter drug products, including finalizing 

19 outstanding monographs and responding to emerging 

20 and novel safety issues; 

21 (3) the performance of the Secretary in carrying 

22 out section 586E of the Federal Food, Drug, and Cos23 metic Act; 


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

2 be, established for the review and regulation of over3 the-counter drug products; and 

4 (5) timeliness, efficiency, and accountability in 

5 reviewing time and extent applications and safety 

6 and effectiveness reviews for over-the-counter drug 

7 products. 

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

9 Federal Food, Drug, and Cosmetic Act, as amended by sec10 tion 3, is further amended by adding at the end the fol11 lowing: 

12 ‘‘SEC. 586G. REPORT. 

13 ‘‘(a) IN GENERAL.— 

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

15 after the date of enactment of the Sunscreen Innova16 tion Act, and on the dates that are 2 and 4 years 

17 thereafter, the Secretary shall issue a report to the 

18 Committee on Health, Education, Labor, and Pen19 sions of the Senate and the Committee on Energy and 

20 Commerce of the House of Representatives describing 

21 actions taken under this subchapter. 

22 ‘‘(2) CONTENTS.—The reports under this sub23 section shall include— 

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

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1 quests, including the number of pending re2 quests— 

3 ‘‘(i) reviewed and the decision times 

4 for each request, measured from the date of 

5 the original request for an eligibility deter6 mination submitted by the sponsor; 

7 ‘‘(ii) resulting in a determination that 

8 the nonprescription sunscreen active ingre9 dient or combination of nonprescription 

10 sunscreen active ingredients is GRASE and 

11 is not misbranded; 

12 ‘‘(iii) resulting in a determination that 

13 the nonprescription sunscreen active ingre14 dient or combination of nonprescription 

15 sunscreen active ingredients is not GRASE 

16 and is misbranded and the reasons for such 

17 determinations; and 

18 ‘‘(iv) for which a determination has 

19 not been made, and an explanation for the 

20 delay, a description of the current status of 

21 each such request, and the length of time 

22 each such request has been pending, meas23 ured from the date of original request for an 

24 eligibility determination by the sponsor; 


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

2 issuing GRASE determinations for requests not 

3 included in the reporting under subparagraph 

4 (A), including the number of such requests— 

5 ‘‘(i) reviewed and the decision times 

6 for each request; 

7 ‘‘(ii) resulting in a determination that 

8 the nonprescription sunscreen active ingre9 dient, combination of nonprescription sun10 screen active ingredients, or other ingredient 

11 is GRASE and is not misbranded; 

12 ‘‘(iii) resulting in a determination that 

13 the nonprescription sunscreen active ingre14 dient, combination of nonprescription sun15 screen active ingredients, or other ingredient 

16 is not GRASE and is misbranded and the 

17 reasons for such determinations; and 

18 ‘‘(iv) for which a determination has 

19 not been made, and an explanation for the 

20 delay, a description of the current status of 

21 each such request, and the length of time 

22 each such request has been pending, meas23 ured from the date of original request for an 

24 eligibility determination by the sponsor; 


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1 ‘‘(C) an annual accounting (including in2 formation from years prior to the date of enact3 ment of the Sunscreen Innovation Act where 

4 such information is available) of the total num5 ber of requests submitted, pending, or completed 

6 under this subchapter, including whether such 

7 requests were the subject of an advisory com8 mittee convened by the Secretary; 

9 ‘‘(D) a description of the staffing and re10 sources relating to the costs associated with the 

11 review and decisionmaking pertaining to re12 quests under this subchapter; 

13 ‘‘(E) a review of the progress made in meet14 ing the deadlines with respect to processing re15 quests under this subchapter; and 

16 ‘‘(F) to the extent the Secretary determines 

17 appropriate, recommendations for process im18 provements in the handling of requests under 

19 this subchapter, including the advisory com20 mittee review process. 

21 ‘‘(b) METHOD.—The Secretary shall publish the re22 ports under subsection (a) in the manner the Secretary de23 termines to be the most effective for efficiently disseminating 

24 the report, including publication of the report on the Inter25 net website of the Food and Drug Administration.’’. 


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Calendar No. 568 

113TH CONGRESS 

2D SESSION S. 2141 

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 

SEPTEMBER 17 (legislative day, SEPTEMBER 16), 2014 

Reported with an amendment 


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