,,ii #aacth ,,congress #b;d ,session ,h4 ,r4 #dbej ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #bi1 #bjad,received ,,an ,,act ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide an alternative process for review of safety and effectiveness of nonprescription sunscreen active ingredients and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,sunscreen ,innovation ,act4 #b4 ,regulation of nonprescription sunscreen active ingredients ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 ,i ,nonprescription sunscreen active ingredients #ehf4 ,definitions ,in this subchapter3 7#a7 ,the term ,advisory ,committee means the ,nonprescription ,drug ,advisory ,committee or any successor to such ,committee4 7#b7 ,the terms generally recognized as safe and effective and ,,grase mean generally recognized1 among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs1 as safe and effective for use under the conditions prescribed1 recommended1 or suggested in the product's labeling1 as described in section #bja7p74 7#c7 ,the term ,,grase determination means1 with respect to a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients1 a determination of whether such ingredients or combination of ingredients is generally recognized as safe and effective and not misbranded for use under the conditions prescribed1 recommended1 or suggested in the product's labeling1 as described in section #bja7p74 7#d7 ,the term nonprescription means not subject to section #ejc7;b77#a74 7#e7 ,the term pending request means each request submitted to the ,secretary-- 7,a7 for consideration for inclusion in the over-the-counter drug monograph system2 7,b7 that was deemed eligible for such review by publication of a notice of eligibility in the ,federal ,register prior to the date of enactment of the ,sunscreen ,innovation ,act2 and 7,c7 for which safety and effectiveness data has been submitted to the ,secretary prior to such date of enactment4 7#f7 ,the term sponsor means the person submitting the request under section #ehf;,a7a71 including a time and extent application under section #ehf;,b1 or the person that submitted the pending request4 7#g7 ,the term sunscreen active ingredient means an active ingredient that is intended for application to the skin of humans for purposes of absorbing1 reflecting1 or scattering radiation4 7#h7 ,the term sunscreen means a product containing one or more sunscreen active ingredients4 #ehf;,a4 ,general provisions 7a7 ,requests ,any person may submit a request to the ,secretary for a determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients1 for use under specified conditions1 to be prescribed1 recommended1 or suggested in the labeling thereof 7including dosage form1 dosage strength1 and route of administration7 is generally recognized as safe and effective and not misbranded4 7b7 ,rules of construction 7#a7 ,currently marketed sunscreens ,nothing in this subchapter shall be construed to affect the marketing of sunscreens that are lawfully marketed in the ,united ,states on or before the date of enactment of this subchapter4 7#b7 ,ensuring safety and effectiveness ,nothing in this subchapter shall be construed to alter the ,secretary's authority to prohibit the marketing of a sunscreen that is not safe and effective or to impose restrictions on the marketing of a sunscreen to ensure safety and effectiveness4 7#c7 ,other products ,nothing in this subchapter shall be construed to affect the ,secretary's regulation of products other than sunscreens4 7c7 ,sunset ,this subchapter shall cease to be effective at the end of the #e-year period beginning on the date of enactment of this subchapter4 #ehf;,b4 ,eligibility determination 7a7 ,in general ,upon receipt of a request under section #ehf;,a7a71 not later than #fj days after the date of receipt of such request1 the ,secretary shall-- 7#a7 determine whether the request is eligible for further review under sections #ehf;,c and #ehf;,d1 as described in subsection 7b72 7#b7 notify the sponsor of the ,secretary's determination2 and 7#c7 make such determination publicly available in accordance with subsection 7c74 7b7 ,criteria for eligibility 7#a7 ,in general ,to be eligible for review under sections #ehf;,c and #ehf;,d1 a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients1 for use under specified conditions1 to be prescribed1 recommended1 or suggested in the labeling thereof1 that-- 7,a7 is not included in the stayed sunscreen monograph in part #ceb of title #ba1 ,code of ,federal ,regulations2 and 7,b7 has been used to a material extent and for a material time1 as described in section #bja7p77#b74 7#b7 ,time and extent application ,a sponsor shall include in a request under section #ehf;,a7a7 a time and extent application including all the information required to meet the standard described in paragraph 7#a77;,b74 7c7 ,public availability 7#a7 ,redactions for confidential information ,if a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is determined to be eligible for further review under subsection 7a77#a71 the ,secretary shall make the request publicly available1 with redactions for information that is treated as confidential under section #eeb7;b7 of title #e1 ,united ,states ,code1 section #aije of title #ah1 ,united ,states ,code1 or section #cja7;j7 of this ,act4 7#b7 ,identification of confidential information by sponsor ,sponsors shall identify any information which the sponsor considers to be confidential information described in paragraph 7#a74 7#c7 ,confidentiality during eligibility review ,the information contained in a request under section #ehf;,a7a7 shall remain confidential during the ,secretary's consideration under this section of whether the request is eligible for further review4 #ehf;,c4 ,data submission2 filing determination 7a7 ,in general ,in the case of a request under section #ehf;,a7a7 that is determined to be eligible under section #ehf;,b for further review under this section and section #ehf;,d-- 7#a7 the ,secretary shall1 in notifying the public under section #ehf;,b7a77#c7 of such eligibility determination1 invite the sponsor of the request and any other interested party to submit1 in support of or otherwise relating to a ,,grase determination-- 7,a7 published and unpublished data and other information related to the safety and effectiveness of the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients for its intended nonprescription uses2 or 7,b7 any other comments2 and 7#b7 not later than #fj days after the submission of such data and other information by the sponsor1 including any revised submission of such data and other information following a refusal to file under subparagraph 7,b71 the ,secretary shall-- 7,a7 7i7 issue a written notification to the sponsor determining that the request under section #ehf;,a7a71 together with such data and other information1 is sufficiently complete to conduct a substantive review and make such notification publicly available2 and 7ii7 file such request2 or 7,b7 issue a written notification to the sponsor refusing to file the request and stating the reasons for the refusal and why the data and other information submitted is not sufficiently complete to conduct a substantive review and make such notification publicly available2 7#c7 the ,secretary shall1 in filing a request under paragraph 7#b7-- 7,a7 invite the public to submit further comments with respect to such filing2 and 7,b7 limit such public comment1 and the comment period under paragraph 7#a71 to the period ending on the date that is #fj days after such filing2 7#d7 if the ,secretary refuses to file the request-- 7,a7 the sponsor may1 within #cj days of receipt of written notification of such refusal1 seek a meeting with the ,secretary regarding whether the ,secretary should file the request2 and 7,b7 the ,secretary shall convene the meeting2 and 7#e7 following any such meeting-- 7,a7 if the sponsor asks that the ,secretary file the request 7with or without amendments to correct any purported deficiencies to the request7 the ,secretary shall file the request over protest1 issue a written notification of the filing to the sponsor1 and make such notification publicly available2 and 7,b7 if the request is so filed over protest1 the ,secretary shall not require the sponsor to resubmit a copy of the request for purposes of such filing4 7b7 ,reasons for refusal to file request ,the ,secretary may refuse to file a request submitted under section #ehf;,a7a7 if the ,secretary determines the data or other information submitted by the sponsor under this section are not sufficiently complete to conduct a substantive review with respect to such request4 7c7 ,public availability 7#a7 ,redactions for confidential information ,the ,secretary shall make data and other information submitted in connection with a request under section #ehf;,a7a7 publicly available1 with redactions for information that is treated as confidential under section #eeb7;b7 of title #e1 ,united ,states ,code1 section #aije of title #ah1 ,united ,states ,code1 or section #cja7;j7 of this ,act4 7#b7 ,identification of confidential information by sponsor ,sponsors or any other individual submitting data or other information under this section shall identify any information which the sponsor or individual considers to be confidential information described in paragraph 7#a74 #ehf;,d4 ,,grase determination 7a7 ,review of new request 7#a7 ,proposed order by ,,cder ,in the case of a request under section #ehf;,a7a71 the ,director of the ,center for ,drug ,evaluation and ,research shall-- 7,a7 not later than #cjj days after the date on which the request is filed under section #ehf;,c7a71 complete the review of the request and issue a proposed order determining that-- 7i7 the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request-- 7,i7 is ,,grase2 and 7,,ii7 is not misbranded2 7ii7 the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request-- 7,i7 is not ,,grase2 or 7,,ii7 is misbranded2 or 7iii7 additional information is necessary to allow the ,director of the ,center for ,drug ,evaluation and ,research to complete the review of such request2 7,b7 within such #cjj-;day period1 convene a meeting of the ,advisory ,committee to review the request under section #ehf;,a7a72 and 7,c7 if the ,director fails to issue such proposed order within the #cjj-;day period referred to in subparagraph 7,a71 transmit the request to the ,commissioner of ,food and ,drugs for review4 7#b7 ,proposed order by ,commissioner ,with respect to a request transmitted to the ,commissioner of ,food and ,drugs under paragraph 7#a77;,c71 the ,commissioner shall1 not later than #fj days after the date of such transmission1 issue-- 7,a7 a proposed order described in paragraph 7#a77;,a77i72 7,b7 a proposed order described in paragraph 7#a77;,a77ii72 or 7,c7 a proposed order described in paragraph 7#a77;,a77iii74 7#c7 ,publication in ,federal ,register2 public comment period ,a proposed order issued under paragraph 7#a7 or 7#b7 with respect to a request shall-- 7,a7 be published in the ,federal ,register2 and 7,b7 solicit public comments for a period of not more than #de days4 7#d7 ,final order by ,,cder ,in the case of a proposed order under paragraph 7#a77;,a7 or 7#b7 with respect to a request1 the ,director of the ,center for ,drug ,evaluation and ,research shall-- 7,a7 issue a final order with respect to the request-- 7i7 in the case of a proposed order under clause 7i7 or 7ii7 of paragraph 7#a77;,a7 or subparagraph 7,a7 or 7,b7 of paragraph 7#b71 not later than #ij days after the end of the public comment period under paragraph 7#c77;,b72 or 7ii7 in the case of a proposed order under paragraph 7#a77;,a77iii7 or paragraph 7#b77;,c71 not later than #baj days after the date on which the sponsor submits the additional information requested pursuant to such proposed order2 or 7,b7 if the ,director fails to issue such final order within such #ij- or #baj-;day period1 as applicable1 transmit such proposed order to the ,commissioner of ,food and ,drugs for review4 7#e7 ,final order by ,commissioner ,with respect to a proposed order transmitted to the ,commissioner of ,food and ,drugs under paragraph 7#d77;,b71 the ,commissioner shall issue a final order with respect to such proposed order not later than #fj days after the date of such transmission4 7b7 ,review of pending requests 7#a7 ,in general ,the review of a pending request shall be carried out by the ,director of the ,center for ,drug ,evaluation and ,research in accordance with paragraph 7#c74 7#b7 ,inapplicability of certain provisions ,sections #ehf;,b and #ehf;,c shall not apply with respect to any pending request4 7#c7 ,proposed order by ,,cder ,the ,director of the ,center for ,drug ,evaluation and ,research shall-- 7,a7 within the timeframe applicable under paragraph 7#d71 complete the review of the request and issue a proposed order determining that-- 7i7 the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request-- 7,i7 is ,,grase2 and 7,,ii7 is not misbranded2 7ii7 the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request-- 7,i7 is not ,,grase2 or 7,,ii7 is misbranded2 or 7iii7 additional information is necessary to allow the ,director of the ,center for ,drug ,evaluation and ,research to complete the review of the pending request2 and 7,b7 if the ,director fails to issue such proposed order within the timeframe applicable under paragraph 7#d71 transmit the pending request to the ,commissioner of ,food and ,drugs for review4 7#d7 ,timeframe for issuance of proposed order by ,,cder ,the ,director of the ,center for ,drug ,evaluation and ,research shall issue a proposed order1 as required by paragraph 7#c77;,a7-- 7,a7 in the case of a pending request for which the ,food and ,drug ,administration has issued a feedback letter before the date of enactment of the ,sunscreen ,innovation ,act1 not later than #de days after such date of enactment2 and 7,b7 in the case of a pending request for which the ,food and ,drug ,administration has not issued a feedback letter before the date of enactment of the ,sunscreen ,innovation ,act1 not later than #ij days after such date of enactment4 7#e7 ,proposed order by ,commissioner ,with respect to a pending request transmitted to the ,commissioner of ,food and ,drugs under paragraph 7#c77;,b71 the ,commissioner shall1 not later than #fj days after the date of such transmission1 issue-- 7,a7 a proposed order described in paragraph 7#c77;,a77i72 7,b7 a proposed order described in paragraph 7#c77;,a77ii72 or 7,c7 a proposed order described in paragraph 7#c77;,a77iii74 7#f7 ,publication in ,federal ,register2 public comment period ,a proposed order issued under paragraph 7#c7 or 7#e7 with respect to a pending request shall-- 7,a7 be published in the ,federal ,register2 and 7,b7 solicit public comments for a period of not more than #de days4 7#g7 ,advisory committee ,for a proposed order issued under paragraph 7#c77;,a77iii7 or 7#e77;,c7 requesting additional information1 an ,advisory ,committee meeting shall be convened if the sponsor requests1 or the ,director of the ,center for ,drug ,evaluation and ,research or the ,commissioner of ,food and ,drugs decides1 to convene such a meeting for the purpose of reviewing the pending request4 7#h7 ,final order by ,,cder ,in the case of a proposed order under paragraph 7#c77;,a7 or 7#e7 with respect to a request1 the ,director of the ,center for ,drug ,evaluation and ,research shall-- 7,a7 issue a final order with respect to the request-- 7i7 in the case of a proposed order under clause 7i7 or 7ii7 of paragraph 7#c77;,a7 or subparagraph 7,a7 or 7,b7 of paragraph 7#e71 not later than #ij days after the end of the public comment period under paragraph 7#c77;,b72 or 7ii7 in the case of a proposed order under paragraph 7#c77;,a77iii7 or paragraph 7#e77;,c7-- 7,i7 if the ,advisory ,committee is not convened pursuant to paragraph 7#g71 not later than #baj days after the date on which the sponsor submits the additional information requested pursuant to such proposed order2 or 7,,ii7 if the ,advisory ,committee is convened pursuant to paragraph 7#g71 not later than #bgj days after date on which the sponsor submits such additional information2 or 7,b7 if the ,director fails to issue such final order within such #ij-1 #baj-1 and #bgj-;day period1 as applicable1 transmit such proposed order to the ,commissioner of ,food and ,drugs for review4 7#i7 ,final order by ,commissioner ,with respect to a proposed order transmitted to the ,commissioner of ,food and ,drugs under paragraph 7#h77;,b71 the ,commissioner shall issue a final order with respect to such proposed order not later than #fj days after the date of such transmission4 7c7 ,advisory committee 7#a7 ,limitations ,the ,food and ,drug ,administration-- 7,a7 shall not be required to convene the ,advisory ,committee-- 7i7 more than once with respect to any request under section #ehf;,a7a7 or any pending request2 or 7ii7 more than twice in any twelve month period with respect to the review of submissions under this section2 and 7,b7 shall not be required to submit more than #c submissions to the ,advisory ,committee per meeting4 7#b7 ,membership ,in appointing the members of the ,advisory ,committee1 the ,secretary may select to serve temporarily as voting members on the ,advisory ,committee-- 7,a7 members of other ,federal advisory committees2 or 7,b7 consultants from outside of the ,department of ,health and ,human ,services who have substantive expertise regarding sunscreen active ingredients4 7d7 ,no delegation ,any responsibility vested by this section in the ,commissioner of ,food and ,drugs is not delegable4 7e7 ,effect of final order 7#a7 ,content ,a final order under subsection 7a77#d71 7a77#e71 7b77#h71 or 7b77#i7 with respect to a request under section #ehf;,a7a7 or a pending request shall determine that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request-- 7,a7 is ,,grase and is not misbranded2 or 7,b7 is not ,,grase or is misbranded4 7#b7 ,active ingredients determined to be ,,grase ,upon issuance of a final order determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and is not misbranded1 the active ingredient or combination of active ingredients shall be permitted to be introduced or delivered into interstate commerce1 for use under the conditions subject to the final order1 in accordance with all requirements applicable to drugs not subject to section #ejc7;b77#a74 7#c7 ,active ingredients determined not to be ,,grase ,upon issuance of a final order determining that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not ,,grase or is misbranded1 the active ingredient or combination of active ingredients shall not be introduced or delivered into interstate commerce1 for use under the conditions subject to the final order1 unless an application submitted pursuant to section #eje7;b7 with respect to such active ingredient or combination of active ingredients is approved4 #ehf;,e4 ,reports 7a7 ,,gao report ,not later than #a year after the date of enactment of the ,sunscreen ,innovation ,act1 the ,comptroller ,general of the ,united ,states shall-- 7#a7 submit a report reviewing the overall progress of the ,secretary in carrying out this subchapter to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives2 and 7#b7 include findings on-- 7,a7 the progress made in completing the review of pending requests2 and 7,b7 the role of the ,office of the ,commissioner of ,food and ,drugs in issuing determinations with respect to pending requests1 including the number of requests transferred to the ,office of the ,commissioner under section #ehf;,d4 7b7 ,secretary's report 7#a7 ,in general ,not later than #a year after the date of enactment of the ,sunscreen ,innovation ,act1 and every #b years thereafter1 the ,secretary shall issue a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives describing actions taken under this section4 ,each report under this subsection shall be posted on the ,internet site of the ,food and ,drug ,administration4 7#b7 ,contents ,the reports under this subsection shall include-- 7,a7 a review of the progress made in issuing ,,grase determinations for pending requests1 including the number of pending requests-- 7i7 reviewed and the decision times for each request1 measured from the date of the original request for an eligibility determination submitted by the sponsor2 7ii7 resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and not misbranded2 7iii7 resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not ,,grase and is misbranded and the reasons for such determinations2 and 7iv7 for which a determination has not been made1 an explanation for the delay1 a description of the current status of each such request1 and the length of time each such request has been pending1 measured from the date of original request for an eligibility determination by the sponsor2 7,b7 a review of the progress made in issuing in a timely manner ,,grase determinations for requests submitted under section #ehf;,a7a71 including the number of such requests-- 7i7 reviewed and the decision times for each request2 7ii7 resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is ,,grase and not misbranded2 7iii7 resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is not ,,grase and is misbranded and the reasons for such determinations2 and 7iv7 for which a determination has not been made1 an explanation for the delay1 a description of the current status of each such request1 and the length of time each such request has been pending1 measured from the date of original request for an eligibility determination by the sponsor2 7,c7 a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to requests under this subchapter2 7,d7 a review of the progress made in meeting the deadlines with respect to processing requests under this subchapter2 7,e7 to the extent the ,secretary determines appropriate1 recommendations for process improvements in the handling of pending and new requests1 including the advisory committee review process2 and 7,f7 recommendations for expanding the applicability of this subchapter to nonprescription active ingredients that are not related to the sunscreen category of over-the-counter drugs4 7c7 ,method ,the ,secretary shall publish the reports required under subsection 7b7 in the manner the ,secretary determines to be the most effective for efficiently disseminating the report1 including publication of the report on the ,internet website of the ,food and ,drug ,administration4 4 #c4 ,guidance 7a7 ,in general 7#a7 ,issuance ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall issue guidance1 in accordance with good guidance practices1 on the implementation of1 and compliance with1 subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b1 including guidance on-- 7,a7 the criteria for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients has been used to a material extent and for a material time1 as described in section #bja7p77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7p77#b772 7,b7 the format and content of a safety and effectiveness data submission2 and 7,c7 the safety and efficacy standards for determining whether a nonprescription sunscreen active ingredients or combination of nonprescription sunscreen active ingredients is generally recognized as safe and effective1 as defined in section #ehf of such subchapter ,i4 7#b7 ,inapplicability of ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to collections of information made for purposes of guidance under this subsection4 7b7 ,submissions pending issuance of final guidance ,irrespective of whether final guidance under subsection 7a7 has been issued-- 7#a7 persons may1 beginning on the date of enactment of this ,act1 make submissions under subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #b2 and 7#b7 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall review and act upon such submissions in accordance with such subchapter4 ,passed the ,house of ,representatives ,july #bh1 #bjad4,karen ,l4 ,haas1,clerk