Sec. 3854. TREATMENT OF SUNSCREEN INNOVATION ACT

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## SEC. 3854 TREATMENT OF SUNSCREEN INNOVATION ACT **[**[21 U.S.C. 360fff-3 note](/us/usc/t21/s360fff-3)**]** ###

(a)Review of Nonprescription Sunscreen Active Ingredients ####

(1)Applicability of section 505g for pending submissions #####

(A)In general A sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that, as of the date of enactment of this Act, is subject to a proposed sunscreen order under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3) may elect, by means of giving written notification to the Secretary of Health and Human Services within 180 calendar days of the enactment of this Act, to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle. #####

(B)Election exercised Upon receipt by the Secretary of Health and Human Services of a timely notification under subparagraph (A)— ######

(i)the proposed sunscreen order involved is deemed to be a request for an order under subsection

(b)of section 505G of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle; and ######

(ii)such order is deemed to have been accepted for filing under subsection (b)(6)(A)(i) of such section 505G. #####

(C)Election not exercised If a notification under subparagraph

(A)is not received by the Secretary of Health and Human Services within 180 calendar days of the date of enactment of this Act, the review of the proposed sunscreen order described in subparagraph (A)— ######

(i)shall continue under section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3); and ######

(ii)shall not be eligible for review under section 505G, added by section 3851 of this subtitle. ####

(2)Definitions In this subsection, the terms “sponsor”, “nonprescription”, “sunscreen active ingredient”, and “proposed sunscreen order” have the meanings given to those terms in section 586 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff). ###

(b)Amendments to Sunscreen Provisions ####

(1)Final sunscreen orders Paragraph

(3)of section 586C(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(e)) is amended to read as follows: > > #### “(3) Relationship to orders under section 505g > > A final sunscreen order shall be deemed to be a final order under section 505G.” > . ####

(2)Meetings Paragraph

(7)of section 586C(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is amended— #####

(A)by striking “ A sponsor may request ” and inserting the following: > > ##### “(A) In general > > A sponsor may request” > ; and #####

(B)by adding at the end the following: > > ##### “(B) Confidential meetings > > A sponsor may request one or more confidential meetings with respect to a proposed sunscreen order, including a letter deemed to be a proposed sunscreen order under paragraph (3), to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order, as appropriate. The Secretary shall convene a confidential meeting with such sponsor in a reasonable time period. If a sponsor requests more than one confidential meeting for the same proposed sunscreen order, the Secretary may refuse to grant an additional confidential meeting request if the Secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order, or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion. The Secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets. This subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.” > . ####

(3)Exclusivity Section 586C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at the end the following: > > ### “(f) Exclusivity > > > #### “(1) In general > > A final sunscreen order shall have the effect of authorizing solely the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) for a period of 18 months, to market a sunscreen ingredient under this section incorporating changes described in paragraph

(2)subject to the limitations under paragraph (4), beginning on the date the requestor (or any licensees, assignees, or successors in interest of such requestor with respect to the subject of such request and listed under paragraph (5)) may lawfully market such sunscreen ingredient pursuant to the order. > > > #### “(2) Changes described > > A change described in this paragraph is a change subject to an order specified in paragraph

(1)that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph (3). > > > #### “(3) Marketed sunscreen > > The marketed sunscreen ingredients described in this paragraph are sunscreen ingredients— > > > ##### “(A) > > marketed in accordance with a final monograph for sunscreen drug products set forth at part 352 of title 21, Code of Federal Regulations (as published at 64 Fed. Reg. 27687); or > > > ##### “(B) > > marketed in accordance with a final order issued under this section. > > > #### “(4) Limitations on exclusivity > > Only one 18-month period may be granted per ingredient under paragraph (1). > > > #### “(5) Listing of licensees, assignees, or successors in interest > > Requestors shall submit to the Secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest under paragraph (1).” > . ####

(4)Sunset provision Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.) is amended by adding at the end the following: > > ## “SEC. 586H SUNSET > > **[**[21 U.S.C. 360fff-8](/us/usc/t21/s360fff-8)**]** > > This subchapter shall cease to be effective at the end of fiscal year 2022.” > . ####

(5)Treatment of final sunscreen order The Federal Food, Drug, and Cosmetic Act is amended by striking section 586E of such Act (21 U.S.C. 360fff-5). ###

(c)Treatment of Authority Regarding Finalization of Sunscreen Monograph **[**[21 U.S.C. 355h note](/us/usc/t21/s355h)**]** ####

(1)In general #####

(A)Revision of final sunscreen order The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this subsection as the “sunscreen order”) for which the content, prior to the date of enactment of this Act, was represented by the final monograph for sunscreen drug products set forth in part 352 of title 21, Code of Federal Regulations (as in effect on May 21, 1999). #####

(B)Issuance of revised sunscreen order; effective date A revised sunscreen order described in subparagraph

(A)shall be— ######

(i)issued in accordance with the procedures described in section 505G(b)(2) of the Federal Food, Drug, and Cosmetic Act; ######

(ii)issued in proposed form not later than 18 months after the date of enactment of this Act; and ######

(iii)issued by the Secretary at least 1 year prior to the effective date of the revised order. ####

(2)Reports If a revised sunscreen order issued under paragraph

(1)does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order. ###

(d)Treatment of Non-Sunscreen Time and Extent Applications **[**[21 U.S.C. 360fff-6 note](/us/usc/t21/s360fff-6)**]** ####

(1)In general Any application described in section 586F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-6) that was submitted to the Secretary pursuant to section 330.14 of title 21, Code of Federal Regulations, as such provisions were in effect immediately prior to the date of enactment date of this Act, shall be extinguished as of such date of enactment, subject to paragraph (2). ####

(2)Order request Nothing in paragraph

(1)precludes the submission of an order request under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle, with respect to a drug that was the subject of an application extinguished under paragraph (1).

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