II 

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 and Mr. ISAKSON) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 Act’’. 


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1 SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN 

2 ACTIVE INGREDIENTS. 

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

4 is amended by adding at the end the following: 

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

6 ACTIVE INGREDIENTS. 

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

8 determine whether nonprescription sunscreen conditions 

9 are generally recognized as safe and effective and shall 

10 ensure that any such conditions that are marketed in the 

11 United States are appropriately labeled. 

12 ‘‘(b) DEFINITIONS.— 

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

14 ingredient’ means any component that is intended to 

15 furnish pharmacological activity or other direct ef16 fect in the diagnosis, cure, mitigation, treatment, or 

17 prevention of disease, or to affect the structure or 

18 function of the body of humans or animals. The 

19 term includes components that may undergo chem20 ical change in the manufacture of a drug and may 

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

22 furnish the specified activity or effect. 

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

24 term ‘sunscreen active ingredient’ means an active 

25 ingredient that absorbs, reflects, or scatters radiVerDate Mar 15 2010 02:17 Mar 21, 2014 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2141.IS S2141

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1 ation in the ultraviolet range at wavelengths from 

2 290 to 400 nanometers. 

3 ‘‘(3) SUNSCREEN CONDITION.—The term ‘sun4 screen condition’ means a sunscreen active ingre5 dient (or a combination of sunscreen active ingredi6 ents), dosage form, dosage strength, or route of ad7 ministration, marketed for a specific nonprescription 

8 use. 

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

10 review under this section, a sunscreen condition shall— 

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

12 monograph; and 

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

14 sunscreen condition in the United States or at least 

15 1 other country, or marketed as a cosmetic or die16 tary supplement in 1 or more counties other than 

17 the United States— 

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

19 and 

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

21 by the Secretary based upon the information 

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

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

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

25 ‘‘(d) APPLICATION FOR ELIGIBILITY.— 


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1 ‘‘(1) IN GENERAL.—A sponsor of a nonprescrip2 tion sunscreen condition described in subsection (c) 

3 desiring to market such condition in the United 

4 States may submit an application to the Secretary, 

5 in such manner and containing such information as 

6 required by the Secretary, including the following: 

7 ‘‘(A) Basic information about the sun8 screen condition (including a description of each 

9 active ingredient, pharmacologic class, intended 

10 nonprescription use, nonprescription strength 

11 and dosage form, route of administration, and 

12 directions for use). 

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

14 sunscreen active ingredient that includes a full 

15 description of the drug substance, including its 

16 physical and chemical characteristics, the meth17 od of synthesis (or isolation) and purification of 

18 the drug substance, and any specifications and 

19 analytical methods necessary to ensure the 

20 identity, strength, quality, and purity of the 

21 drug substance, including reference to the cur22 rent edition of the official National Formulary, 

23 the United States Pharmacopeia, or foreign 

24 compendiums, where applicable. 


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

2 sunscreen condition has been marketed. 

3 ‘‘(D) The cumulative total number of dos4 age units sold for each dosage form of the sun5 screen condition, including total weight of the 

6 active ingredient, package size for each dosage 

7 form in which the condition is marketed as non8 prescription, and an estimate of the minimum 

9 number of potential consumer exposures to the 

10 condition. 

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

12 label) for each country in which the sunscreen 

13 condition is marketed and any changes in use 

14 pattern that have occurred over time. 

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

16 sunscreen condition has been withdrawn from 

17 marketing or in which an application for non18 prescription marketing approval has been de19 nied and an explanation for such withdrawal or 

20 application denial. 

21 ‘‘(2) SUNSCREEN CONDITIONS THAT HAVE NOT

22 BEEN MARKETED IN THE UNITED STATES FOR 5

23 CONTINUOUS YEARS.— 

24 ‘‘(A) IN GENERAL.—In the case of an ap25 plication with respect to a nonprescription sunVerDate Mar 15 2010 02:33 Mar 21, 2014 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2141.IS S2141

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1 screen condition that has not been marketed in 

2 the United States for 5 continuous years, in ad3 dition to the information required under para4 graph (1), the sponsor shall submit the fol5 lowing information for each country in which 

6 the sunscreen condition has been marketed: 

7 ‘‘(i) The manner in which the sun8 screen condition has been marketed to con9 sumers. If the sunscreen condition is mar10 keted to consumers as a nonprescription 

11 pharmacy only condition, the Secretary 

12 may require supplemental information. 

13 ‘‘(ii) A description of the population 

14 demographics and the source from which 

15 this information has been compiled, to en16 sure that the sunscreen condition’s use can 

17 be reasonably extrapolated to the popu18 lation of the United States. 

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

20 system for identifying adverse drug experi21 ences, especially those found in non22 prescription marketing experience, includ23 ing method of collection if applicable. 

24 ‘‘(iv) A statement of how long the 

25 sunscreen condition has been marketed in 


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1 each country and how long the current 

2 product labeling has been in use, accom3 panied by a copy of the current product la4 beling, including a translation into English 

5 of any labeling that is not in English, and 

6 a statement of whether the current product 

7 labeling has been authorized, accepted, or 

8 approved by a regulatory body in each 

9 country where the condition is marketed. 

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

11 sunscreen condition is marketed as a pre12 scription drug only and an explanation for 

13 such restriction. 

14 ‘‘(B) SUNSCREEN CONDITIONS THAT HAVE

15 BEEN MARKETED IN MORE THAN 5 COUN16 TRIES.— 

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

18 sunscreen condition that has been mar19 keted as a nonprescription sunscreen in 

20 more than 5 countries, with a minimum of 

21 5 continuous years of marketing in at least 

22 one such country, the sponsor— 

23 ‘‘(I) may submit information in 

24 accordance with clauses (i) through 


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1 (iv) of subparagraph (A) with respect 

2 to only 5 such countries, including— 

3 ‘‘(aa) the country with a 

4 minimum of 5 continuous years 

5 of nonprescription marketing; 

6 ‘‘(bb) the country with the 

7 longest duration of marketing; 

8 and 

9 ‘‘(cc) the country with the 

10 most support for marketing, such 

11 as a large volume of sales with 

12 cultural diversity among users of 

13 the product; and 

14 ‘‘(II) shall explain the basis for 

15 the countries selected under subclause 

16 (I); and 

17 ‘‘(III) shall provide information 

18 from more than 5 countries if such in19 formation is needed to support the ap20 plication. 

21 ‘‘(ii) REQUIREMENT.—If the sun22 screen condition meets the criteria under 

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

24 1 or more countries listed in section 

25 802(b)(1)(A), at least 1 such country shall 


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1 be included among the 5 countries selected 

2 under such clause (i)(I). 

3 ‘‘(3) PENDING APPLICATIONS.—The require4 ments of this subsection shall not apply to a sun5 screen condition deemed eligible for review of safety 

6 and effectiveness by publication of a notice of eligi7 bility in the Federal Register prior to the date of en8 actment of the Sunscreen Innovation Act. Applica9 tions for such sunscreen conditions shall be consid10 ered in accordance with subsection (g). 

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

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

13 application publicly available, with redactions for confiden14 tial commercial information or trade secret information, 

15 and any other information exempt from disclosure pursu16 ant to section 1905 of title 18, United States Code, section 

17 552(b) of title 5, United States Code, or section 301(j) 

18 of this Act. Applications shall remain confidential during 

19 the Secretary’s consideration of eligibility. 

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

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

22 than 60 days after the submission of an eligibility 

23 application under subsection (d), the Secretary shall 

24 determine if the sunscreen condition is eligible for 

25 further review for safety and effectiveness. In the 


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1 case of a sunscreen condition determined to be eligi2 ble, the Secretary shall publish a notice of eligibility 

3 in the Federal Register, and provide interested per4 sons an opportunity to submit published and unpub5 lished data related to the safety and effectiveness of 

6 the sunscreen condition for its intended nonprescrip7 tion uses, in accordance with paragraph (2). In the 

8 case of a sunscreen condition determined not eligi9 ble, the Secretary shall issue a letter to the sponsor, 

10 which shall be made publicly available. 

11 ‘‘(2) SAFETY AND EFFECTIVENESS DATA SUB12 MISSIONS.— 

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

14 publication in the Federal Register of an appli15 cation deemed eligible, as described in para16 graph (1), the sponsor and other interested par17 ties shall submit safety and effectiveness data 

18 to the Secretary for further review, as described 

19 in subparagraph (B). 

20 ‘‘(B) REQUIRED SUBMISSIONS REGARDING

21 DATA.—Submissions under this paragraph shall 

22 include the following: 

23 ‘‘(i) HUMAN SAFETY 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 as to the 

6 safety of each individual active compo7 nent, and pertinent medical and sci8 entific 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 as 

17 to the safety of combinations of the 

18 individual active component, and per19 tinent medical and scientific lit20 erature. 

21 ‘‘(ii) EFFICACY DATA.— 

22 ‘‘(I) INDIVIDUAL ACTIVE COMPO23 NENTS.—With respect to individual 

24 active components, controlled studies, 

25 partially controlled or uncontrolled 


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1 studies, documented case reports, per2 tinent marketing experiences that may 

3 influence a determination on the effi4 cacy of each individual active compo5 nent, pertinent medical and scientific 

6 literature. 

7 ‘‘(II) COMBINATIONS OF INDI8 VIDUAL ACTIVE COMPONENTS.—With 

9 respect to combinations of the indi10 vidual active components, controlled 

11 studies, partially controlled or uncon12 trolled studies, documented case re13 ports, pertinent marketing experiences 

14 that may influence a determination on 

15 the efficacy of combinations of the in16 dividual active components, and perti17 nent medical and scientific literature. 

18 ‘‘(iii) DATA SETTING FORTH MEDICAL

19 RATIONALE AND PURPOSE.—A summary of 

20 the data and views setting forth the med21 ical rationale and purpose (or lack thereof) 

22 for the sunscreen condition and the sci23 entific basis (or lack thereof) for the con24 clusion that the condition has been proven 

25 safe and effective for the intended use. If 


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1 there is an absence of controlled studies in 

2 the material submitted, an explanation as 

3 to why such studies are not considered 

4 necessary must be included. 

5 ‘‘(iv) OFFICIAL DRUG MONOGRAPH.— 

6 An applicable United States Pharma7 copoeia or National Formulary for the sun8 screen active ingredient or a proposed 

9 standard for inclusion in an article to be 

10 recognized in an official drug monograph 

11 for the active ingredient, including infor12 mation showing that the official or pro13 posed compendial monograph for the active 

14 ingredient is consistent with the active in15 gredient used in the studies establishing 

16 safety and effectiveness and with the active 

17 ingredient marketed in the nonprescription 

18 product to a material extent and for a ma19 terial time. If differences exist between the 

20 official or proposed compendial monograph 

21 for the active ingredient and the active in22 gredient that is the subject of the applica23 tion, sponsor shall explain such differences. 

24 ‘‘(v) ADVERSE DRUG EXPERIENCES.— 

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1 ences, as defined by the Secretary, from 

2 each country where the condition has been 

3 or is currently marketed as a prescription 

4 drug or as a nonprescription drug or prod5 uct. 

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

7 In addition to the information required under 

8 subparagraph (B), the sponsor may submit in9 formation with respect to animal safety data, 

10 including controlled studies and partially con11 trolled or uncontrolled studies, in the case of an 

12 application for individual active components, 

13 and controlled studies and partially controlled 

14 or uncontrolled studies in the case of an appli15 cation for combinations of individual active 

16 components. 

17 ‘‘(D) CONFIDENTIALITY OF SUBMIS18 SIONS.—The Secretary shall make data and in19 formation submitted by the sponsor, or pursu20 ant to a notice requesting safety and effective21 ness data published in the Federal Register, 

22 publicly available, with redactions for confiden23 tial commercial information or trade secret in24 formation, and any other information exempt 

25 from disclosure pursuant to section 1905 of 


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

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

3 this Act. 

4 ‘‘(3) NEW SUNSCREEN CONDITION APPLICATION

5 SUBMISSION TO THE ADVISORY COMMITTEE.—Not 

6 later than 30 days after the end of the public com7 ment period described in paragraph (2), the Sec8 retary shall submit the application and the safety 

9 and effectiveness data submitted under paragraph 

10 (2) to the Nonprescription Drugs Advisory Com11 mittee (referred to in this section as the ‘advisory 

12 committee’) for review. 

13 ‘‘(g) PENDING SUNSCREEN CONDITION APPLICA14 TIONS.—Not later than 30 days after the date of enact15 ment of the Sunscreen Innovation Act, the Secretary shall 

16 submit to the advisory committee all safety and effective17 ness data submitted with respect to each application for 

18 review of sunscreen conditions that the Secretary had de19 termined, prior to the date of enactment of the Sunscreen 

20 Innovation Act, to be eligible for review of safety and ef21 fectiveness and for which the information required under 

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

23 to such date of enactment. 

24 ‘‘(h) REVIEW AND RECOMMENDATION FOR NON25 PRESCRIPTION SUNSCREEN CONDITION.— 


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

2 the advisory committee to evaluate the safety and ef3 fectiveness data submitted in accordance with sub4 section (f)(2) or (g). 

5 ‘‘(2) STANDARDS.—In evaluating a non6 prescription sunscreen condition under paragraph 

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

8 in effect at the time of the application, including 

9 regulations with respect to— 

10 ‘‘(A) the safety of the nonprescription sun11 screen condition; 

12 ‘‘(B) the effectiveness of the nonprescrip13 tion sunscreen condition; 

14 ‘‘(C) the benefit-to-risk ratio of the non15 prescription sunscreen condition; and 

16 ‘‘(D) the labeling of the nonprescription 

17 sunscreen condition. 

18 ‘‘(3) COMMUNICATIONS BETWEEN ADVISORY

19 COMMITTEE AND OTHER INDIVIDUALS WHO SUBMIT

20 DATA.—The advisory committee shall have the au21 thority to communicate with the sponsor and other 

22 individuals who submit data during the advisory 

23 committee’s review, including requesting clarification 

24 or additional information. 

25 ‘‘(4) RECOMMENDATIONS.— 


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1 ‘‘(A) IN GENERAL.—For each such sub2 mission under subsection (f)(3) or (g), the advi3 sory committee shall make one of the following 

4 recommendations to the Secretary: 

5 ‘‘(i) The sunscreen condition is gen6 erally recognized as safe and effective (in7 cluding any or all indications), including 

8 nonprescription sunscreen conditions for 

9 which a new drug application has been ap10 proved by the Secretary. 

11 ‘‘(ii) Insufficient information has been 

12 provided to support a recommendation that 

13 the sunscreen condition is generally recog14 nized as safe and effective (including any 

15 or all indications). 

16 ‘‘(iii) The sunscreen condition is not 

17 generally recognized as safe and effective 

18 to be marketed or sold, unless an applica19 tion with respect to such condition is ap20 proved under section 505(b). 

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

22 shall make a recommendation under subpara23 graph (A) not later than 180 days after the ad24 visory committee receives the application and 


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1 data submitted under subsection (f)(3) or sub2 section (g). 

3 ‘‘(C) RESUBMISSION OF DATA.—If the ad4 visory committee recommends that insufficient 

5 information has been provided, in accordance 

6 with subparagraph (A)(ii), the advisory com7 mittee shall make such recommendation not 

8 later than 180 days after the date on which 

9 such additional information is submitted. 

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

11 EVALUATION AND RESEARCH.— 

12 ‘‘(1) IN GENERAL.—The Center for Drug Eval13 uation and Research shall respond to the rec14 ommendations of the advisory committee under sub15 section (h)(4) as follows: 

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

17 the advisory committee described in clause (i) 

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

19 after the advisory committee issues the rec20 ommendation, the Center for Drug Evaluation 

21 and Research shall issue a determination af22 firming or denying the recommendation of the 

23 advisory committee. If the Center for Drug 

24 Evaluation and Research affirms the rec25 ommendation of the advisory committee, or if 


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1 the Center for Drug Evaluation and Research 

2 takes no action regarding the recommendation 

3 within 45 days of receiving such recommenda4 tion, the nonprescription sunscreen condition 

5 shall be generally recognized as safe and effec6 tive, not misbranded, and permitted to be mar7 keted and sold in accordance with all applicable 

8 rules and regulations for over-the-counter 

9 drugs. 

10 ‘‘(B) In the case of a recommendation de11 scribed in clause (ii) of such subsection, the 

12 Center for Drug Evaluation and Research shall 

13 issue a determination affirming or denying the 

14 recommendation of the advisory committee, to 

15 be made publicly available, within 45 days of 

16 receiving the recommendation, and inform the 

17 sponsor that the sponsor must submit addi18 tional information to the advisory committee in 

19 order to continue the review by the advisory 

20 committee. 

21 ‘‘(C) In the case of a recommendation de22 scribed in clause (iii) of such subsection, the 

23 Center for Drug Evaluation and Research shall 

24 issue a determination affirming or denying the 

25 recommendation of the advisory committee, to 


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1 be made publicly available, within 45 days of 

2 receiving such recommendation, and indicate 

3 whether such sunscreen condition determined to 

4 be not generally recognized as safe and effective 

5 to be marketed and sold, unless an application 

6 with respect to such condition is approved 

7 under section 505(b), or whether additional 

8 data must be submitted to the advisory com9 mittee. 

10 ‘‘(2) SUPERVISORY REVIEW OF DETERMINA11 TION.— 

12 ‘‘(A) IN GENERAL.—Any person may re13 quest a supervisory review of a determination of 

14 the Center for Drug Evaluation and Research 

15 to not accept a recommendation of an advisory 

16 committee. Such review may be conducted at 

17 the next supervisory or higher level above the 

18 individual who made the determination. 

19 ‘‘(B) REQUEST FOR SUPERVISORY RE20 VIEW.—A request described in subparagraph 

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

22 than 30 days after such decision and shall indi23 cate in the request whether such person seeks 

24 an in-person meeting or a teleconference. The 

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1 conference review, if so requested, not later 

2 than 30 days after such request is made. The 

3 Secretary shall issue a decision to the person 

4 requesting a review under this paragraph not 

5 later than 45 days after the meeting. 

6 ‘‘(C) STANDARD OF SUPERVISORY RE7 VIEW.—The Secretary shall be authorized to 

8 overturn a determination of the Center for 

9 Drug Evaluation and Research not to accept a 

10 recommendation of the advisory committee if 

11 the supervisory review results in a decision by 

12 the reviewer that the individual who made the 

13 determination did not provide reasonable and 

14 sufficient substantive support for the decision 

15 to disregard the advisory committee’s rec16 ommendation. 

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

18 the Secretary overturns a determination by the 

19 Center for Drug Evaluation and Research not 

20 to accept a favorable recommendation of an ad21 visory committee, the nonprescription sunscreen 

22 condition shall be generally recognized as safe 

23 and effective, not misbranded, and permitted to 

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1 plicable rules and regulations for over-the2 counter drugs. 

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

4 made through supervisory review shall con5 stitute final agency action subject to judicial re6 view. 

7 ‘‘(j) REPORTS.— 

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

9 the date of enactment of the Sunscreen Innovation 

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

11 the Secretary shall issue a report to Congress de12 scribing actions taken under this section. 

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

14 (1) shall include— 

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

16 issuing in a timely manner decisions on the 

17 safety and effectiveness for sunscreen condi18 tions for applications pending as of the date of 

19 enactment of the Sunscreen Innovation Act, in20 cluding the number of pending applications— 

21 ‘‘(i) reviewed and the decision times 

22 for each application, measured from the 

23 date of original eligibility application sub24 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. 

Æ 


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