--- kind: "diff" citation: "H.R. 4250" bill: "113-hr-4250" heading: "Sunscreen Innovation Act" from: "ih" from_label: "Introduced in House" to: "rh" to_label: "Reported in House" sections_amended: 2 sections_added: 0 sections_removed: 0 url: "https://uscodex.org/bills/113/hr/4250/changes/rh" --- # H.R. 4250 — what changed H.R. 4250, Sunscreen Innovation Act — 2 sections amended between Introduced in House and Reported in House. Edits are marked `struck` and `inserted`. ## Sec. 2 Regulation of nonprescription sunscreen active ingredients - Subchapter A of chapter Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following: - “524B. Procedures for classifying “I Nonprescription sunscreen active ingredients - “(a) In general—The Secretary shall review and determine whether nonprescription sunscreen conditions are generally recognized as safe and effective and shall ensure that any such conditions that are marketed in the United States are appropriately labeled.“586. Definitions - “(b) Definitions“In this subchapter: - “(1) Active ingredient—The The term active ingredient “Advisory Committee” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of humans Nonprescription Drug Advisory Committee or animals. The term includes components that may undergo chemical change in the manufacture of a drug and may be present in a drug in a modified form intended any successor to furnish the specified activity or effect.such Committee. - “(2) Sunscreen active ingredient—The term sunscreen active ingredient means an active ingredient that absorbs, reflects, The terms “generally recognized as safe and effective” and “GRASE” mean generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or scatters radiation suggested in the ultraviolet range at wavelengths from 290 to 400 nanometers.product’s labeling, as described in section 201(p). - “(3) Sunscreen condition—The The term sunscreen condition means “GRASE determination” means, with respect to a nonprescription sunscreen active ingredient (or or a combination of nonprescription sunscreen active ingredients), dosage form, dosage strength, ingredients, a determination of whether such ingredients or route combination of administration, marketed ingredients is generally recognized as safe and effective and not misbranded for a specific nonprescription use.use under the conditions prescribed, recommended, or suggested in the product’s labeling, as described in section 201(p). - “(c) Criteria for eligibility—To be eligible for review under this section, a sunscreen condition shall—“(4) The term “nonprescription” means not subject to section 503(b)(1). - “(1) not be included in “(5) The term “pending request” means each request submitted to the stayed sunscreen monograph; andSecretary— - “(2) have been marketed as a nonprescription sunscreen condition in the United States or at least 1 other country, or marketed as a cosmetic or dietary supplement “(A) for consideration for inclusion in 1 or more counties other than the United States—over-the-counter drug monograph system; - “(A) “(B) that was deemed eligible for such review by publication of a minimum notice of 5 continuous years; eligibility in the Federal Register prior to the date of enactment of the Sunscreen Innovation Act; and - “(B) in sufficient quantity, as determined by “(C) for which safety and effectiveness data has been submitted to the Secretary based upon the information submitted under subparagraphs (D) and (E) prior to such date of subsection (d)(1) and, if applicable, subsection (d)(2)(A)(ii).enactment. - “(d) Application for eligibility“(6) The term “sponsor” means the person submitting the request under section 586A(a), including a time and extent application under section 586B, or the person that submitted the pending request. - “(1) In general—A sponsor of a nonprescription sunscreen condition described in subsection (c) desiring to market such condition in the United States may submit “(7) The term “sunscreen active ingredient” means an active ingredient that is intended for application to the Secretary, in such manner and containing such information as required by the Secretary, including the following:skin of humans for purposes of absorbing, reflecting, or scattering radiation. - “(A) Basic information about the sunscreen condition (including “(8) The term “sunscreen” means a description of each product containing one or more sunscreen active ingredient, pharmacologic class, intended nonprescription use, nonprescription strength and dosage form, route of administration, and directions for use).ingredients. - “(B) A detailed chemical description of the sunscreen active ingredient that includes a full description of the drug substance, including its physical and chemical characteristics, the method of synthesis (or isolation) and purification of the drug substance, and any specifications and analytical methods necessary to ensure the identity, strength, quality, and purity of the drug substance, including reference to the current edition of the official National Formulary, the United States Pharmacopeia, or foreign compendiums, where applicable.“586A. General provisions - “(C) A list “(a) Requests—Any person may submit a request to the Secretary for a determination of each country whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in which the sunscreen condition has been marketed.labeling thereof (including dosage form, dosage strength, and route of administration) is generally recognized as safe and effective and not misbranded. - “(D) The cumulative total number of dosage units sold for each dosage form of the sunscreen condition, including total weight of the active ingredient, package size for each dosage form in which the condition is marketed as nonprescription, and an estimate of the minimum number “(b) Rules of potential consumer exposures to the condition.construction - “(E) The use pattern (according to the label) for each country “(1) Currently marketed sunscreens—Nothing in which this subchapter shall be construed to affect the sunscreen condition is marketing of sunscreens that are lawfully marketed and any changes in use pattern that have occurred over time.the United States on or before the date of enactment of this subchapter. - “(F) A list of all countries “(2) Ensuring safety and effectiveness—Nothing in which this subchapter shall be construed to alter the sunscreen condition has been withdrawn from Secretary's authority to prohibit the marketing of a sunscreen that is not safe and effective or in which an application for nonprescription to impose restrictions on the marketing approval has been denied of a sunscreen to ensure safety and an explanation for such withdrawal or application denial.effectiveness. - “(2) Sunscreen conditions that have not been marketed “(3) Other products—Nothing in this subchapter shall be construed to affect the United States for 5 continuous yearsSecretary’s regulation of products other than sunscreens. - “(A) In general—In the case of an application with respect to a nonprescription sunscreen condition that has not been marketed in the United States for 5 continuous years, in addition “(c) Sunset—This subchapter shall cease to the information required under paragraph (1), be effective at the sponsor shall submit end of the following information for each country in which 5-year period beginning on the sunscreen condition has been marketed:date of enactment of this subchapter. - “(i) The manner in which the sunscreen condition has been marketed to consumers. If the sunscreen condition is marketed to consumers as a nonprescription pharmacy only condition, the Secretary may require supplemental information.“586B. Eligibility determination - “(ii) A description “(a) In general—Upon receipt of the population demographics and the source from which this information has been compiled, to ensure that the sunscreen condition's use can be reasonably extrapolated to a request under section 586A(a), not later than 60 days after the population date of receipt of such request, the United States.Secretary shall— - “(iii) A description of “(1) determine whether the country’s system request is eligible for identifying adverse drug experiences, especially those found further review under sections 586C and 586D, as described in nonprescription marketing experience, including method of collection if applicable.subsection (b); - “(iv) A statement of how long the sunscreen condition has been marketed in each country and how long the current product labeling has been in use, accompanied by a copy of “(2) notify the current product labeling, including a translation into English of any labeling that is not in English, and a statement sponsor of whether the current product labeling has been authorized, accepted, or approved by a regulatory body in each country where the condition is marketed.Secretary’s determination; and - “(v) A list of all countries where the sunscreen condition is marketed as a prescription drug only and an explanation for “(3) make such restriction.determination publicly available in accordance with subsection (c). - “(B) Sunscreen conditions that have been marketed in more than 5 countries“(b) Criteria for eligibility - “(i) “(1) In general—In the case of general—To be eligible for review under sections 586C and 586D, a sunscreen condition that has been marketed as request shall be for a nonprescription sunscreen in more than 5 countries, with a minimum of 5 continuous years active ingredient or combination of marketing nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in at least one such country, the sponsor—labeling thereof, that— - “(I) may submit information “(A) is not included in accordance with clauses (i) through (iv) the stayed sunscreen monograph in part 352 of subparagraph (A) with respect to only 5 such countries, including—title 21, Code of Federal Regulations; and - “(aa) the country with “(B) has been used to a minimum of 5 continuous years of nonprescription marketing;material extent and for a material time, as described in section 201(p)(2). - “(bb) “(2) Time and extent application—A sponsor shall include in a request under section 586A(a) a time and extent application including all the country with information required to meet the longest duration of marketing; andstandard described in paragraph (1)(B). - “(cc) the country with the most support for marketing, such as a large volume of sales with cultural diversity among users of the product; and“(c) Public availability - “(II) “(1) 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 (a)(1), the Secretary shall explain make the basis request publicly available, with redactions for the countries selected information that is treated as confidential under subclause (I); andsection 552(b) of title 5, United States Code, section 1905 of title 18, United States Code, or section 301(j) of this Act. - “(III) shall provide “(2) Identification of confidential information from more than 5 countries if such by sponsor—Sponsors shall identify any information is needed to support which the application.sponsor considers to be confidential information described in paragraph (1). - “(ii) Requirement—If the sunscreen condition meets the criteria under items (aa) through (cc) of clause (i)(I) in 1 or more countries listed “(3) Confidentiality during eligibility review—The information contained in a request under section 802(b)(1)(A), at least 1 such country 586A(a) shall be included among remain confidential during the 5 countries selected Secretary’s consideration under such clause (i)(I).this section of whether the request is eligible for further review. - “(3) Pending applications—The requirements of this subsection shall not apply to a sunscreen condition deemed eligible for review of safety and effectiveness by publication of a notice of eligibility in the Federal Register prior to the date of enactment of the Sunscreen Innovation Act. Applications for such sunscreen conditions shall be considered in accordance with subsection (g).“586C. Data submission; filing determination - “(e) Public availability—If “(a) In general—In the case of a condition request under section 586A(a) that is found determined to be eligible under subsection (d), the Secretary shall make the application publicly available, with redactions for confidential commercial information or trade secret information, and any other information exempt from disclosure pursuant to section 1905 of title 18, United States Code, 586B for further review under this section 552(b) of title 5, United States Code, or and section 301(j) of this Act. Applications shall remain confidential during the Secretary's consideration of eligibility.586D— - “(f) New sunscreen condition application“(1) the Secretary shall, in notifying the public under section 586B(a)(3) of such eligibility determination, invite the sponsor of the request and any other interested party to submit, in support of or otherwise relating to a GRASE determination— - “(1) Eligibility determination—Not later than 60 days after the submission of an eligibility application under subsection (d), the Secretary shall determine if the sunscreen condition is eligible for further review for safety and effectiveness. In the case of a sunscreen condition determined to be eligible, the Secretary shall publish a notice of eligibility in the Federal Register, and provide interested persons an opportunity to submit “(A) published and unpublished data and other information related to the safety and effectiveness of the nonprescription sunscreen condition active ingredient or combination of nonprescription sunscreen active ingredients for its intended nonprescription uses, in accordance with paragraph (2). In the case of a sunscreen condition determined not eligible, the Secretary shall issue a letter to the sponsor, which shall be made publicly available.uses; or - “(2) Safety and effectiveness data submissions“(B) any other comments; and - “(A) In general—Within “(2) not later than 60 days of the publication in after the Federal Register submission of an application deemed eligible, as described in paragraph (1), the sponsor such data and other interested parties shall submit safety and effectiveness information by the sponsor, including any revised submission of such data and other information following a refusal to file under subparagraph (B), the Secretary for further review, as described in subparagraph (B).shall— - “(B) Required submissions regarding data—Submissions under this paragraph shall include the following:“(A) - “(i) Human safety dataissue a written notification to the sponsor determining that the request under section 586A(a), together with such data and other information, is sufficiently complete to conduct a substantive review and make such notification publicly available; and - “(I) Individual active components—With respect to individual active components, controlled studies, partially controlled or uncontrolled studies, documented case reports, pertinent marketing experiences that may influence a determination as to the safety of each individual active component, and pertinent medical and scientific literature.“(ii) file such request; or - “(II) Combinations of individual active components—With respect “(B) issue a written notification to combinations of the individual active components, controlled studies, partially controlled or uncontrolled studies, documented case reports, pertinent marketing experiences that may influence a determination as sponsor refusing to file the safety of combinations of request and stating the individual active component, reasons for the refusal and pertinent medical why the data and scientific literature.other information submitted is not sufficiently complete to conduct a substantive review and make such notification publicly available; - “(ii) Efficacy data“(3) the Secretary shall, in filing a request under paragraph (2)— - “(I) Individual active components—With “(A) invite the public to submit further comments with respect to individual active components, controlled studies, partially controlled or uncontrolled studies, documented case reports, pertinent marketing experiences that may influence a determination on the efficacy of each individual active component, pertinent medical and scientific literature.such filing; and - “(II) Combinations of individual active components—With respect “(B) limit such public comment, and the comment period under paragraph (1), to combinations of the individual active components, controlled studies, partially controlled or uncontrolled studies, documented case reports, pertinent marketing experiences that may influence a determination period ending on the efficacy of combinations of the individual active components, and pertinent medical and scientific literature.date that is 60 days after such filing; - “(iii) Data setting forth medical rationale and purpose—A summary of the data and views setting forth the medical rationale and purpose (or lack thereof) for the sunscreen condition and the scientific basis (or lack thereof) for the conclusion that the condition has been proven safe and effective for the intended use. If there is an absence of controlled studies in “(4) if the material submitted, an explanation as Secretary refuses to why such studies are not considered necessary must be included.file the request— - “(iv) Official drug monograph—An applicable United States Pharmacopoeia or National Formulary for “(A) the sunscreen active ingredient or sponsor may, within 30 days of receipt of written notification of such refusal, seek a proposed standard for inclusion in an article to be recognized in an official drug monograph for the active ingredient, including information showing that the official or proposed compendial monograph for the active ingredient is consistent with the active ingredient used in the studies establishing safety and effectiveness and meeting with the active ingredient marketed in the nonprescription product to a material extent and for a material time. If differences exist between the official or proposed compendial monograph for the active ingredient and the active ingredient that is Secretary regarding whether the subject of Secretary should file the application, sponsor shall explain such differences.request; and - “(v) Adverse drug experiences—A list of all serious adverse drug experiences, as defined by “(B) the Secretary, from each country where Secretary shall convene the condition has been or is currently marketed as a prescription drug or as a nonprescription drug or product.meeting; and - “(C) Optional animal safety data—In addition to the information required under subparagraph (B), the sponsor may submit information with respect to animal safety data, including controlled studies and partially controlled or uncontrolled studies, in the case of an application for individual active components, and controlled studies and partially controlled or uncontrolled studies in the case of an application for combinations of individual active components.“(5) following any such meeting— - “(D) Confidentiality of submissions—The “(A) if the sponsor asks that the Secretary shall make data and information submitted by file the sponsor, request (with or pursuant without amendments to a notice requesting safety and effectiveness data published in the Federal Register, publicly available, with redactions for confidential commercial information or trade secret information, and correct any other information exempt from disclosure pursuant purported deficiencies to section 1905 of title 18, United States Code, section 552(b) of title 5, United States Code, or section 301(j) the request) the Secretary shall file the request over protest, issue a written notification of this Act.the filing to the sponsor, and make such notification publicly available; and - “(3) New sunscreen condition application submission to the advisory committee—Not later than 30 days after the end of “(B) if the public comment period described in paragraph (2), request is so filed over protest, the Secretary shall submit the application and the safety and effectiveness data submitted under paragraph (2) to not require the Nonprescription Drugs Advisory Committee (referred sponsor to in this section as resubmit a copy of the “advisory committee”) request for review.purposes of such filing. - “(g) Pending sunscreen condition applications—Not later than 30 days after the date of enactment of the Sunscreen Innovation Act, the “(b) Reasons for refusal to file request—The Secretary shall submit may refuse to the advisory committee all safety and effectiveness data file a request submitted with respect to each application for review of sunscreen conditions that under section 586A(a) if the Secretary had determined, prior to the date of enactment of the Sunscreen Innovation Act, to be eligible for review of safety and effectiveness and for which determines the data or other information required under subsection (f)(2) has been submitted to by the Secretary prior sponsor under this section are not sufficiently complete to conduct a substantive review with respect to such date of enactment.request. - “(h) Review and recommendation for nonprescription sunscreen condition“(c) Public availability - “(1) In general—The Redactions for confidential information—The Secretary shall require the advisory committee to evaluate the safety and effectiveness make data and other information submitted in accordance connection with subsection (f)(2) a request under section 586A(a) publicly available, with redactions for information that is treated as confidential under section 552(b) of title 5, United States Code, section 1905 of title 18, United States Code, or (g).section 301(j) of this Act. - “(2) Standards—In evaluating a nonprescription sunscreen condition Identification of confidential information by sponsor—Sponsors or any other individual submitting data or other information under paragraph (1), the advisory committee this section shall use identify any information which the regulations sponsor or individual considers to be confidential information described in effect at the time of the application, including regulations with respect to—paragraph (1). - “(A) the safety of the nonprescription sunscreen condition;“586D. GRASE determination - “(B) the effectiveness “(a) Review of the nonprescription sunscreen condition;new request - “(C) “(1) Proposed order by CDER—In the benefit-to-risk ratio case of a request under section 586A(a), the nonprescription sunscreen condition; andDirector of the Center for Drug Evaluation and Research shall— - “(D) “(A) not later than 300 days after the labeling date on which the request is filed under section 586C(a), complete the review of the nonprescription sunscreen condition.request and issue a proposed order determining that— - “(3) Communications between advisory committee and other individuals who submit data—The advisory committee shall have “(i) the authority to communicate with nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the sponsor and other individuals who submit data during subject of the advisory committee's review, including requesting clarification or additional information.request— - “(4) Recommendations“(I) is GRASE; and - “(A) In general—For each such submission under subsection (f)(3) or (g), the advisory committee shall make one of the following recommendations to the Secretary:“(II) is not misbranded; - “(i) The “(ii) the nonprescription sunscreen condition is generally recognized as safe and effective (including any active ingredient or all indications), including combination of nonprescription sunscreen conditions for which a new drug application has been approved by active ingredients that is the Secretary.subject of the request— - “(ii) Insufficient information has been provided to support a recommendation that the sunscreen condition “(I) is generally recognized as safe and effective (including any or all indications).not GRASE; or - “(iii) The sunscreen condition is not generally recognized as safe and effective to be marketed or sold unless an application with respect to such condition “(II) is approved under section 505(b).misbranded; or - “(B) Timing—The advisory committee shall make a recommendation under subparagraph (A) not later than 180 days after “(iii) additional information is necessary to allow the advisory committee receives Director of the application Center for Drug Evaluation and data submitted under subsection (f)(3) or subsection (g).Research to complete the review of such request; - “(C) Resubmission “(B) within such 300-day period, convene a meeting of data—If the advisory committee recommends that insufficient information has been provided, in accordance with subparagraph (A)(ii), the advisory committee shall make such recommendation not later than 180 days after Advisory Committee to review the date on which such additional information is submitted.request under section 586A(a): and - “(i) Determination by “(C) if the Center for Drug Evaluation Director fails to issue such proposed order within the 300-day period referred to in subparagraph (A), transmit the request to the Commissioner of Food and ResearchDrugs for review. - “(1) In general—The Center for Drug Evaluation and Research shall respond “(2) Proposed order by Commissioner—With respect to a request transmitted to the recommendations Commissioner of the advisory committee Food and Drugs under subsection (h)(4) as follows:paragraph (1)(C), the Commissioner shall, not later than 60 days after the date of such transmission, issue— - “(A) In the case of a recommendation by the advisory committee proposed order described in clause (i) of subsection (h)(4), not later than 45 days after the advisory committee issues the recommendation, the Center for Drug Evaluation and Research shall issue a determination affirming or denying the recommendation of the advisory committee. If the Center for Drug Evaluation and Research affirms the recommendation of the advisory committee, or if the Center for Drug Evaluation and Research takes no action regarding the recommendation within 45 days of receiving such recommendation, the nonprescription sunscreen condition shall be generally recognized as safe and effective, not misbranded, and permitted to be marketed and sold in accordance with all applicable rules and regulations for over-the-counter drugs.paragraph (1)(A)(i); - “(B) In the case of a recommendation proposed order described in clause (ii) of such subsection, the Center for Drug Evaluation and Research shall issue a determination affirming or denying the recommendation of the advisory committee, to be made publicly available, within 45 days of receiving the recommendation, and inform the sponsor that the sponsor must submit additional information to the advisory committee in order to continue the review by the advisory committee.paragraph (1)(A)(ii); or - “(C) In the case of a recommendation proposed order described in clause (iii) of such subsection, the Center for Drug Evaluation and Research shall issue a determination affirming or denying the recommendation of the advisory committee, to be made publicly available, within 45 days of receiving such recommendation, and indicate whether such sunscreen condition determined to be not generally recognized as safe and effective to be marketed and sold unless an application with respect to such condition is approved under section 505(b), or whether additional data must be submitted to the advisory committee.paragraph (1)(A)(iii). - “(2) Supervisory review of determination“(3) Publication in Federal Register; public comment period—A proposed order issued under paragraph (1) or (2) with respect to a request shall— - “(A) In general—Any person may request a supervisory review of a determination of the Center for Drug Evaluation and Research to not accept a recommendation of an advisory committee. Such review may be conducted at the next supervisory or higher level above the individual who made published in the determination.Federal Register; and - “(B) Request solicit public comments for supervisory review—A request described in subparagraph (A) shall be made to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference. The Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this paragraph period of not later more than 45 days after the meeting.days. - “(C) Standard “(4) Final order by CDER—In the case of supervisory review—The Secretary shall be authorized a proposed order under paragraph (1)(A) or (2) with respect to overturn a determination request, the Director of the Center for Drug Evaluation and Research not to accept a recommendation of the advisory committee if the supervisory review results in a decision by the reviewer that the individual who made the determination did not provide reasonable and sufficient substantive support for the decision to disregard the advisory committee's recommendation.shall— - “(D) Supervisory review decision—If the Secretary overturns “(A) issue a determination by the Center for Drug Evaluation and Research not final order with respect to accept a favorable recommendation of an advisory committee, the nonprescription sunscreen condition shall be generally recognized as safe and effective, not misbranded, and permitted to be marketed and sold in accordance with all applicable rules and regulations for over-the-counter drugs.request— - “(E) Final agency action—A decision made through supervisory review shall constitute final agency action subject to judicial review.“(i) in the case of a proposed order under clause (i) or (ii) of paragraph (1)(A) or subparagraph (A) or (B) of paragraph (2), not later than 90 days after the end of the public comment period under paragraph (3)(B); or - “(j) Reports“(ii) in the case of a proposed order under paragraph (1)(A)(iii) or paragraph (2)(C), not later than 210 days after the date on which the sponsor submits the additional information requested pursuant to such proposed order; or - “(1) In general—Not later than 1 year after the date of enactment of the Sunscreen Innovation Act, on March 1, 2015, and every 2 years thereafter, “(B) if the Secretary shall Director fails to issue a report such final order within such 90- or 210-day period, as applicable, transmit such proposed order to Congress describing actions taken under this section.the Commissioner of Food and Drugs for review. - “(2) Contents—The reports “(5) Final order by Commissioner—With respect to a proposed order transmitted to the Commissioner of Food and Drugs under paragraph (1) (4)(B), the Commissioner shall include—issue a final order with respect to such proposed order not later than 60 days after the date of such transmission. - “(A) a review of the progress made in issuing in a timely manner decisions on the safety and effectiveness for sunscreen conditions for applications pending as of the date of enactment of the Sunscreen Innovation Act, including the number “(b) Review of pending applications—requests - “(i) reviewed and the decision times for each application, measured from the date “(1) In general—The review of original eligibility application submission a pending request shall be carried out by the sponsor;Director of the Center for Drug Evaluation and Research in accordance with paragraph (3). - “(ii) resulting in a determination “(2) Inapplicability of generally recognized as safe and effective certain provisions—Sections 586B and 586C shall not misbranded;apply with respect to any pending request. - “(iii) resulting in a determination “(3) Proposed order by CDER—The Director of not generally recognized as safe and effective and not misbranded and the reasons Center for such determinations; andDrug Evaluation and Research shall— - “(iv) for which a determination has not been made, an explanation for the delay, a description of the current status of each such application, and “(A) within the length of time such applications have been pending, measured from timeframe applicable under paragraph (4), complete the date review of original eligibility application submission by the sponsor;request and issue a proposed order determining that— - “(B) a review of “(i) the progress made in issuing in a timely manner a decision on safety and effectiveness for nonprescription sunscreen condition applications submitted after the date of enactment active ingredient or combination of the Sunscreen Innovation Act, including nonprescription sunscreen active ingredients that is the number subject of such applications—the pending request— - “(i) reviewed and the decision times for each application;“(I) is GRASE; and - “(ii) resulting in a determination of generally recognized as safe and effective and “(II) is not misbranded; andmisbranded; - “(iii) resulting in a determination “(ii) the nonprescription sunscreen active ingredient or combination of not generally recognized as safe and effective and not misbranded and nonprescription sunscreen active ingredients that is the reasons for such determinations;subject of the pending request— - “(C) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications;“(I) is not GRASE; or - “(D) a review of the progress in meeting the deadlines with respect to processing applications under this section;“(II) is misbranded; or - “(E) “(iii) additional information is necessary to allow the extent Director of the Secretary determines appropriate, recommendations Center for process improvements in Drug Evaluation and Research to complete the handling review of the pending and new applications; request; and - “(F) recommendations for expanding “(B) if the applicability of this section Director fails to nonprescription active ingredients or conditions that are not related issue such proposed order within the timeframe applicable under paragraph (4), transmit the pending request to the sunscreen category Commissioner of over-the-counter drugs.Food and Drugs for review. - “(3) Method—The Secretary shall publish the reports required under this subsection in the manner the Secretary determines to be the most effective “(4) Timeframe for efficiently disseminating the report, including publication issuance of the report on the Internet website proposed order by CDER—The Director of the Food and Center for Drug Administration.Evaluation and Research shall issue a proposed order, as required by paragraph (3)(A)— - “(k) Rules “(A) in the case of constructiona pending request for which the Food and Drug Administration has issued a feedback letter before the date of enactment of the Sunscreen Innovation Act, not later than 45 days after such date of enactment; and - “(1) Authority to withdraw or suspend—Nothing “(B) in this section shall be construed to alter the Secretary's authority to withdraw or suspend from case of a pending request for which the market Food and Drug Administration has not issued a drug that feedback letter before the Secretary determines to be unsafe or ineffective.date of enactment of the Sunscreen Innovation Act, not later than 90 days after such date of enactment. - “(2) Other conditions—Nothing in “(5) Proposed order by Commissioner—With respect to a pending request transmitted to the section shall affect Commissioner of Food and Drugs under paragraph (3)(B), the Secretary's authority to review nonprescription conditions other Commissioner shall, not later than sunscreen conditions.”60 days after the date of such transmission, issue— - “(A) a proposed order described in paragraph (3)(A)(i); - “(B) a proposed order described in paragraph (3)(A)(ii); or - “(C) a proposed order described in paragraph (3)(A)(iii). - “(6) Publication in Federal Register; public comment period—A proposed order issued under paragraph (3) or (5) with respect to a pending request shall— - “(A) be published in the Federal Register; and - “(B) solicit public comments for a period of not more than 45 days. - “(7) Advisory committee—For a proposed order issued under paragraph (3)(A)(iii) or (5)(C) requesting additional information, an Advisory Committee meeting shall be convened if the sponsor requests, or the Director of the Center for Drug Evaluation and Research or the Commissioner of Food and Drugs decides, to convene such a meeting for the purpose of reviewing the pending request. - “(8) Final order by CDER—In the case of a proposed order under paragraph (3)(A) or (5) with respect to a request, the Director of the Center for Drug Evaluation and Research shall— - “(A) issue a final order with respect to the request— - “(i) in the case of a proposed order under clause (i) or (ii) of paragraph (3)(A) or subparagraph (A) or (B) of paragraph (5), not later than 90 days after the end of the public comment period under paragraph (3)(B); or - “(ii) in the case of a proposed order under paragraph (3)(A)(iii) or paragraph (5)(C)— - “(I) if the Advisory Committee is not convened pursuant to paragraph (7), not later than 210 days after the date on which the sponsor submits the additional information requested pursuant to such proposed order; or - “(II) if the Advisory Committee is convened pursuant to paragraph (7), not later than 270 days after date on which the sponsor submits such additional information; or - “(B) if the Director fails to issue such final order within such 90-, 210-, and 270-day period, as applicable, transmit such proposed order to the Commissioner of Food and Drugs for review. - “(9) Final order by Commissioner—With respect to a proposed order transmitted to the Commissioner of Food and Drugs under paragraph (8)(B), the Commissioner shall issue a final order with respect to such proposed order not later than 60 days after the date of such transmission. - “(c) Advisory committee - “(1) Limitations—The Food and Drug Administration— - “(A) shall not be required to convene the Advisory Committee— - “(i) more than once with respect to any request under section 586A(a) or any pending request; or - “(ii) more than twice in any twelve month period with respect to the review of submissions under this section; and - “(B) shall not be required to submit more than 3 submissions to the Advisory Committee per meeting. - “(2) Membership—In appointing the members of the Advisory Committee, the Secretary may select to serve temporarily as voting members on the Advisory Committee— - “(A) members of other Federal advisory committees; or - “(B) consultants from outside of the Department of Health and Human Services who have substantive expertise regarding sunscreen active ingredients. - “(d) No delegation—Any responsibility vested by this section in the Commissioner of Food and Drugs is not delegable. - “(e) Effect of final order - “(1) Content—A final order under subsection (a)(4), (a)(5), (b)(8), or (b)(9) with respect to a request under section 586A(a) 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— - “(A) is GRASE and is not misbranded; or - “(B) is not GRASE or is misbranded. - “(2) 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 misbranded, the active ingredient or combination of active ingredients shall be permitted to be introduced or delivered into interstate commerce, for use under the conditions subject to the final order, in accordance with all requirements applicable to drugs not subject to section 503(b)(1). - “(3) 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 misbranded, the active ingredient or combination of active ingredients shall not be introduced or delivered into interstate commerce, for use under the conditions subject to the final order, unless an application submitted pursuant to section 505(b) with respect to such active ingredient or combination of active ingredients is approved. - “586E. Reports - “(a) GAO report—Not later than 1 year after the date of enactment of the Sunscreen Innovation Act, the Comptroller General of the United States shall— - “(1) submit a report reviewing the overall progress of the Secretary in carrying out this subchapter to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives; and - “(2) include findings on— - “(A) the progress made in completing the review of pending requests; and - “(B) the role of the Office of the Commissioner of Food and Drugs in issuing determinations with respect to pending requests, including the number of requests transferred to the Office of the Commissioner under section 586D. - “(b) Secretary’s report - “(1) In general—Not later than 1 year after the date of enactment of the Sunscreen Innovation Act, and every 2 years thereafter, the Secretary shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives describing actions taken under this section. Each report under this subsection shall be posted on the Internet site of the Food and Drug Administration. - “(2) Contents—The reports under this subsection shall include— - “(A) a review of the progress made in issuing GRASE determinations for pending requests, including the number of pending requests— - “(i) reviewed and the decision times for each request, measured from the date of the original request for an eligibility determination submitted by the sponsor; - “(ii) resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and not misbranded; - “(iii) 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 determinations; and - “(iv) for which a determination has not been made, an explanation for the delay, a description of the current status of each such request, and the length of time each such request has been pending, measured from the date of original request for an eligibility determination by the sponsor; - “(B) a review of the progress made in issuing in a timely manner GRASE determinations for requests submitted under section 586A(a), including the number of such requests— - “(i) reviewed and the decision times for each request; - “(ii) resulting in a determination that the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE and not misbranded; - “(iii) 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 determinations; and - “(iv) for which a determination has not been made, an explanation for the delay, a description of the current status of each such request, and the length of time each such request has been pending, measured from the date of original request for an eligibility determination by the sponsor; - “(C) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to requests under this subchapter; - “(D) a review of the progress made in meeting the deadlines with respect to processing requests under this subchapter; - “(E) to the extent the Secretary determines appropriate, recommendations for process improvements in the handling of pending and new requests, including the advisory committee review process; and - “(F) recommendations for expanding the applicability of this subchapter to nonprescription active ingredients that are not related to the sunscreen category of over-the-counter drugs. - “(c) Method—The Secretary shall publish the reports required under subsection (b) in the manner the Secretary determines to be the most effective for efficiently disseminating the report, including publication of the report on the Internet website of the Food and Drug Administration.” ## Sec. 3 Guidance - (a) In general— - (1) Issuance— Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance, in accordance with good guidance practices, on the implementation of, and compliance with, subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by section 2, including guidance on— - (A) 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 time, as described in section 201(p)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(p)(2)); - (B) the format and content of a safety and effectiveness data submission; and - (C) 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 effective, as defined in section 586 of such subchapter I. - (2) Inapplicability of Paperwork Reduction Act— Chapter 35 of title 44, United States Code, shall not apply to collections of information made for purposes of guidance under this subsection. - Not later than 180 days after the date of enactment of this Act, the Secretary shall issue determinations with respect to— - (b) Submissions pending issuance of final guidance— the appropriate testing and labeling requirements for sunscreens sold as an aerosol; andIrrespective of whether final guidance under subsection (a) has been issued— - (1) persons may, beginning on the date of enactment of this Act, make submissions under subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by section 2; and - (2) the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall review and act upon such submissions in accordance with such subchapter. - (2) whether sunscreen may contain a label indicating a sun protection factor greater than 50.