Sunscreen Innovation Act

Bill: 113-hr-4250
Sponsor: full_name: Rep. Whitfield, Ed [R-KY-1]
Introduced: 2014-03-13
Policy area: Health
Subjects: Congressional oversight

Consumer affairs

Drug safety, medical device, and laboratory regulation

Health promotion and preventive care

Musculoskeletal and skin diseases
Latest action: action_date: 2014-07-29
text: Received in the Senate.

Summaries:
action_date: 2014-03-13
action_desc: Introduced in House
text: <p>Sunscreen Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreens.</p> <p>Requires the Secretary of Health and Human Services (HHS) to review and determine whether OTC sunscreens are generally recognized as safe and effective and ensure that any sunscreens marketed in the United States are appropriately labeled.</p> <p>Makes sunscreens that have been marketed for five continuous years in the United States or other countries and in sufficient quantity eligible for review under this Act. </p> <p>Establishes a framework for the review and approval by the Food and Drug Administration (FDA) of OTC sunscreens with new active ingredients. Sets forth time frame requirements for review. Requires applications for review to include safety and efficacy data as well as adverse drug experience information.</p> <p>Directs the Secretary to report on the progress made in issuing timely decisions on the safety and effectiveness of OTC sunscreens.</p> <p>Requires the Secretary to make determinations on the testing and labeling of aerosol sunscreens and on whether a sunscreen may contain a label indicating a sun protection factor (SPF) greater than 50.</p>

action_date: 2014-07-24
action_desc: Reported to House with amendment(s)
text: <p>Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.</p> <p>Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.</p> <p>Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).</p> <p>Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.</p> <p>Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.</p> <p>Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.</p> Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.

action_date: 2014-07-28
action_desc: Passed House amended
text: <p><b>(This measure has not been amended since it was reported to the House on July 24, 2014. The summary of that version is repeated here.)</b></p> <p>Sunscreen Innovation Act - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish a process for the review and approval of over-the-counter (OTC) sunscreen active ingredients.</p> <p>Allows any person to request that the Secretary of Health and Human Services (HHS) determine whether an OTC sunscreen active ingredient or combination of ingredients is safe and effective.</p> <p>Requires the Secretary to review any request regarding a sunscreen active ingredient or combination of ingredients that has been in use and that is not included in the stayed sunscreen monograph published by the Food and Drug Administration (FDA).</p> <p>Directs the Secretary to invite the sponsor of the request to provide data and other information on the safety and efficacy of the sunscreen active ingredient or combination of ingredients. Requires the Secretary to determine whether the provided information is sufficient to conduct a review, and if so, file the request, and if not, explain to the sponsor why the provided information is insufficient.</p> <p>Requires the Director of the Center for Drug Evaluation and Research to complete a review of a filed request and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients within 300 days for new requests or a shorter timeframe for requests pending before enactment of this Act. Directs the Commissioner of Food and Drugs to make the determination if the Director does not make a determination in the allowed timeframe.</p> <p>Allows sunscreen active ingredients that are determined to be safe and effective to be used in OTC sunscreen products.</p> Directs the Comptroller General (GAO) to report on the progress of the Secretary in establishing this process and the role of the Commissioner of Food and Drugs in issuing determinations on pending requests. Requires the Secretary to report on the decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.

tv_txt: I 113th CONGRESS 2d Session H. R. 4250 IN THE HOUSE OF REPRESENTATIVES March 13, 2014 Mr. Whitfield (for himself and Mr. Dingell ) introduced the following bill; which was referred to the Committee on Energy and Commerce 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. Short title This Act may be cited as the Sunscreen Innovation Act . 2. Regulation of nonprescription sunscreen active ingredients Subchapter A of chapter V ( 21 U.S.C. 351 et seq. ) is amended by adding at the end the following: 524B. Procedures for classifying 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. (b) Definitions (1) Active ingredient The term active ingredient 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 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 to furnish the specified activity or effect. (2) Sunscreen active ingredient The term sunscreen active ingredient means an active ingredient that absorbs, reflects, or scatters radiation in the ultraviolet range at wavelengths from 290 to 400 nanometers. (3) Sunscreen condition The term sunscreen condition means a sunscreen active ingredient (or a combination of sunscreen active ingredients), dosage form, dosage strength, or route of administration, marketed for a specific nonprescription use. (c) Criteria for eligibility To be eligible for review under this section, a sunscreen condition shall— (1) not be included in the stayed sunscreen monograph; and (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 in 1 or more counties other than the United States— (A) for a minimum of 5 continuous years; and (B) in sufficient quantity, as determined by the Secretary based upon the information submitted under subparagraphs (D) and (E) of subsection (d)(1) and, if applicable, subsection (d)(2)(A)(ii). (d) Application for eligibility (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 an application to the Secretary, in such manner and containing such information as required by the Secretary, including the following: (A) Basic information about the sunscreen condition (including a description of each active ingredient, pharmacologic class, intended nonprescription use, nonprescription strength and dosage form, route of administration, and directions for use). (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. (C) A list of each country in which the sunscreen condition has been marketed. (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 of potential consumer exposures to the condition. (E) The use pattern (according to the label) for each country in which the sunscreen condition is marketed and any changes in use pattern that have occurred over time. (F) A list of all countries in which the sunscreen condition has been withdrawn from marketing or in which an application for nonprescription marketing approval has been denied and an explanation for such withdrawal or application denial. (2) Sunscreen conditions that have not been marketed in the United States for 5 continuous years (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 to the information required under paragraph (1), the sponsor shall submit the following information for each country in which the sunscreen condition has been marketed: (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. (ii) A description 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 the population of the United States. (iii) A description of the country’s system for identifying adverse drug experiences, especially those found in nonprescription marketing experience, including method of collection if applicable. (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 the current product labeling, including a translation into English of any labeling that is not in English, and a statement of whether the current product labeling has been authorized, accepted, or approved by a regulatory body in each country where the condition is marketed. (v) A list of all countries where the sunscreen condition is marketed as a prescription drug only and an explanation for such restriction. (B) Sunscreen conditions that have been marketed in more than 5 countries (i) In general In the case of a sunscreen condition that has been marketed as a nonprescription sunscreen in more than 5 countries, with a minimum of 5 continuous years of marketing in at least one such country, the sponsor— (I) may submit information in accordance with clauses (i) through (iv) of subparagraph (A) with respect to only 5 such countries, including— (aa) the country with a minimum of 5 continuous years of nonprescription marketing; (bb) the country with the longest duration of marketing; and (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 (II) shall explain the basis for the countries selected under subclause (I); and (III) shall provide information from more than 5 countries if such information is needed to support the application. (ii) Requirement If the sunscreen condition meets the criteria under items (aa) through (cc) of clause (i)(I) in 1 or more countries listed in section 802(b)(1)(A), at least 1 such country shall be included among the 5 countries selected under such clause (i)(I). (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). (e) Public availability If a condition is found 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, section 552(b) of title 5, United States Code, or section 301(j) of this Act. Applications shall remain confidential during the Secretary's consideration of eligibility. (f) New sunscreen condition application (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 published and unpublished data related to the safety and effectiveness of the sunscreen condition 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. (2) Safety and effectiveness data submissions (A) In general Within 60 days of the publication in the Federal Register of an application deemed eligible, as described in paragraph (1), the sponsor and other interested parties shall submit safety and effectiveness data to the Secretary for further review, as described in subparagraph (B). (B) Required submissions regarding data Submissions under this paragraph shall include the following: (i) Human safety data (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) Combinations of individual active components With respect 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 to the safety of combinations of the individual active component, and pertinent medical and scientific literature. (ii) Efficacy data (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 on the efficacy of each individual active component, pertinent medical and scientific literature. (II) Combinations of individual active components With respect 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 on the efficacy of combinations of the individual active components, and pertinent medical and scientific literature. (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 the material submitted, an explanation as to why such studies are not considered necessary must be included. (iv) Official drug monograph An applicable United States Pharmacopoeia or National Formulary for the sunscreen active ingredient or 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 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 the subject of the application, sponsor shall explain such differences. (v) Adverse drug experiences A list of all serious adverse drug experiences, as defined by the Secretary, from each country where the condition has been or is currently marketed as a prescription drug or as a nonprescription drug or product. (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. (D) Confidentiality of submissions The Secretary shall make data and information submitted by the sponsor, or pursuant 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 any other information exempt from disclosure pursuant to section 1905 of title 18, United States Code, section 552(b) of title 5, United States Code, or section 301(j) of this Act. (3) New sunscreen condition application submission to the advisory committee Not later than 30 days after the end of the public comment period described in paragraph (2), the Secretary shall submit the application and the safety and effectiveness data submitted under paragraph (2) to the Nonprescription Drugs Advisory Committee (referred to in this section as the advisory committee ) for review. (g) Pending sunscreen condition applications Not later than 30 days after the date of enactment of the Sunscreen Innovation Act , the Secretary shall submit to the advisory committee all safety and effectiveness data submitted with respect to each application for review of sunscreen conditions that 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 the information required under subsection (f)(2) has been submitted to the Secretary prior to such date of enactment. (h) Review and recommendation for nonprescription sunscreen condition (1) In general The Secretary shall require the advisory committee to evaluate the safety and effectiveness data submitted in accordance with subsection (f)(2) or (g). (2) Standards In evaluating a nonprescription sunscreen condition under paragraph (1), the advisory committee shall use the regulations in effect at the time of the application, including regulations with respect to— (A) the safety of the nonprescription sunscreen condition; (B) the effectiveness of the nonprescription sunscreen condition; (C) the benefit-to-risk ratio of the nonprescription sunscreen condition; and (D) the labeling of the nonprescription sunscreen condition. (3) Communications between advisory committee and other individuals who submit data The advisory committee shall have the authority to communicate with the sponsor and other individuals who submit data during the advisory committee's review, including requesting clarification or additional information. (4) Recommendations (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: (i) The sunscreen condition is generally recognized as safe and effective (including any or all indications), including nonprescription sunscreen conditions for which a new drug application has been approved by the Secretary. (ii) Insufficient information has been provided to support a recommendation that the sunscreen condition is generally recognized as safe and effective (including any or all indications). (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 is approved under section 505(b). (B) Timing The advisory committee shall make a recommendation under subparagraph (A) not later than 180 days after the advisory committee receives the application and data submitted under subsection (f)(3) or subsection (g). (C) Resubmission 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 the date on which such additional information is submitted. (i) Determination by the Center for Drug Evaluation and Research (1) In general The Center for Drug Evaluation and Research shall respond to the recommendations of the advisory committee under subsection (h)(4) as follows: (A) In the case of a recommendation by the advisory committee 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. (B) In the case of a recommendation 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. (C) In the case of a recommendation 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. (2) Supervisory review of determination (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 the determination. (B) Request 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 not later than 45 days after the meeting. (C) Standard of supervisory review The Secretary shall be authorized to overturn a determination 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. (D) Supervisory review decision If the Secretary overturns a determination by the Center for Drug Evaluation and Research not 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. (E) Final agency action A decision made through supervisory review shall constitute final agency action subject to judicial review. (j) Reports (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, the Secretary shall issue a report to Congress describing actions taken under this section. (2) Contents The reports under paragraph (1) shall include— (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 of pending applications— (i) reviewed and the decision times for each application, measured from the date of original eligibility application submission by the sponsor; (ii) resulting in a determination of generally recognized as safe and effective and not misbranded; (iii) resulting in a determination of not generally recognized as safe and effective and not 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 application, and the length of time such applications have been pending, measured from the date of original eligibility application submission by the sponsor; (B) a review of the progress made in issuing in a timely manner a decision on safety and effectiveness for sunscreen condition applications submitted after the date of enactment of the Sunscreen Innovation Act , including the number of such applications— (i) reviewed and the decision times for each application; (ii) resulting in a determination of generally recognized as safe and effective and not misbranded; and (iii) resulting in a determination of not generally recognized as safe and effective and not misbranded and the reasons for such determinations; (C) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications; (D) a review of the progress in meeting the deadlines with respect to processing applications under this section; (E) to the extent the Secretary determines appropriate, recommendations for process improvements in the handling of pending and new applications; and (F) recommendations for expanding the applicability of this section to nonprescription active ingredients or conditions that are not related to the sunscreen category of over-the-counter drugs. (3) Method The Secretary shall publish the reports required under this subsection 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. (k) Rules of construction (1) Authority to withdraw or suspend Nothing in this section shall be construed to alter the Secretary's authority to withdraw or suspend from the market a drug that the Secretary determines to be unsafe or ineffective. (2) Other conditions Nothing in the section shall affect the Secretary's authority to review nonprescription conditions other than sunscreen conditions. . 3. Sunscreen testing and labeling Not later than 180 days after the date of enactment of this Act, the Secretary shall issue determinations with respect to— (1) the appropriate testing and labeling requirements for sunscreens sold as an aerosol; and (2) whether sunscreen may contain a label indicating a sun protection factor greater than 50.

tv_txt: IB 113th CONGRESS 2d Session H. R. 4250 IN THE HOUSE OF REPRESENTATIVES AN ACT 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. Short title This Act may be cited as the Sunscreen Innovation Act . 2. Regulation of nonprescription sunscreen active ingredients 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: I Nonprescription sunscreen active ingredients 586. Definitions In this subchapter: (1) The term Advisory Committee means the Nonprescription Drug Advisory Committee or any successor to such Committee. (2) 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 suggested in the product’s labeling, as described in section 201(p). (3) The term GRASE determination means, with respect to a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, 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 prescribed, recommended, or suggested in the product’s labeling, as described in section 201(p). (4) The term nonprescription means not subject to section 503(b)(1). (5) The term pending request means each request submitted to the Secretary— (A) for consideration for inclusion in the over-the-counter drug monograph system; (B) 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 Act; and (C) for which safety and effectiveness data has been submitted to the Secretary prior to such date of enactment. (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. (7) The term sunscreen active ingredient means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering radiation. (8) The term sunscreen means a product containing one or more sunscreen active ingredients. 586A. General provisions (a) 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 ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is generally recognized as safe and effective and not misbranded. (b) Rules of construction (1) 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 subchapter. (2) 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 effectiveness. (3) Other products Nothing in this subchapter shall be construed to affect the Secretary’s regulation of products other than sunscreens. (c) Sunset This subchapter shall cease to be effective at the end of the 5-year period beginning on the date of enactment of this subchapter. 586B. Eligibility determination (a) In general Upon receipt of a request under section 586A(a), not later than 60 days after the date of receipt of such request, the Secretary shall— (1) determine whether the request is eligible for further review under sections 586C and 586D, as described in subsection (b); (2) notify the sponsor of the Secretary’s determination; and (3) make such determination publicly available in accordance with subsection (c). (b) Criteria for eligibility (1) In general To be eligible for review under sections 586C and 586D, a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof, that— (A) is not included in the stayed sunscreen monograph in part 352 of title 21, Code of Federal Regulations; and (B) has been used to a material extent and for a material time, as described in section 201(p)(2). (2) Time and extent application A sponsor shall include in a request under section 586A(a) a time and extent application including all the information required to meet the standard described in paragraph (1)(B). (c) Public availability (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 make the request 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 section 301(j) of this Act. (2) Identification of confidential information by sponsor Sponsors shall identify any information which the sponsor considers to be confidential information described in paragraph (1). (3) Confidentiality during eligibility review The information contained in a request under section 586A(a) shall remain confidential during the Secretary’s consideration under this section of whether the request is eligible for further review. 586C. Data submission; filing determination (a) In general In the case of a request under section 586A(a) that is determined to be eligible under section 586B for further review under this section and section 586D— (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— (A) 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 uses; or (B) any other comments; and (2) not later than 60 days after the submission of such data and other information by the sponsor, including any revised submission of such data and other information following a refusal to file under subparagraph (B), the Secretary shall— (A) (i) issue 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 (ii) file such request; or (B) 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 available; (3) the Secretary shall, in filing a request under paragraph (2)— (A) invite the public to submit further comments with respect to such filing; and (B) limit such public comment, and the comment period under paragraph (1), to the period ending on the date that is 60 days after such filing; (4) if the Secretary refuses to file the request— (A) the sponsor may, within 30 days of receipt of written notification of such refusal, seek a meeting with the Secretary regarding whether the Secretary should file the request; and (B) the Secretary shall convene the meeting; and (5) following any such meeting— (A) if the sponsor asks that the Secretary file the request (with or without amendments to correct any purported deficiencies to the request) the Secretary shall file the request over protest, issue a written notification of the filing to the sponsor, and make such notification publicly available; and (B) if the request is so filed over protest, the Secretary shall not require the sponsor to resubmit a copy of the request for purposes of such filing. (b) Reasons for refusal to file request The Secretary may refuse to file a request submitted under section 586A(a) 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 request. (c) Public availability (1) Redactions for confidential information The Secretary shall make data and other information submitted in connection with 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 section 301(j) of this Act. (2) 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 (1). 586D. GRASE determination (a) Review of new request (1) Proposed order by CDER In the case of a request under section 586A(a), the Director of the Center for Drug Evaluation and Research shall— (A) not later than 300 days after the date on which the request is filed under section 586C(a), complete the review of the request and issue a proposed order determining that— (i) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request— (I) is GRASE; and (II) is not misbranded; (ii) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request— (I) is not GRASE; or (II) is misbranded; or (iii) additional information is necessary to allow the Director of the Center for Drug Evaluation and Research to complete the review of such request; (B) within such 300-day period, convene a meeting of the Advisory Committee to review the request under section 586A(a); and (C) if the 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 Drugs for review. (2) Proposed order by Commissioner With respect to a request transmitted to the Commissioner of Food and Drugs under paragraph (1)(C), the Commissioner shall, not later than 60 days after the date of such transmission, issue— (A) a proposed order described in paragraph (1)(A)(i); (B) a proposed order described in paragraph (1)(A)(ii); or (C) a proposed order described in paragraph (1)(A)(iii). (3) Publication in Federal Register; public comment period A proposed order issued under paragraph (1) or (2) with respect to a request shall— (A) be published in the Federal Register; and (B) solicit public comments for a period of not more than 45 days. (4) Final order by CDER In the case of a proposed order under paragraph (1)(A) or (2) 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 (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 (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 (B) if the Director fails to issue such final order within such 90- or 210-day period, as applicable, transmit such proposed order to the Commissioner of Food and Drugs for review. (5) Final order by Commissioner With respect to a proposed order transmitted to the Commissioner of Food and Drugs under paragraph (4)(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. (b) Review of pending requests (1) 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 (3). (2) Inapplicability of certain provisions Sections 586B and 586C shall not apply with respect to any pending request. (3) Proposed order by CDER The Director of the Center for Drug Evaluation and Research shall— (A) within the timeframe applicable under paragraph (4), complete the review of the request and issue a proposed order determining that— (i) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request— (I) is GRASE; and (II) is not misbranded; (ii) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request— (I) is not GRASE; or (II) is misbranded; or (iii) additional information is necessary to allow the Director of the Center for Drug Evaluation and Research to complete the review of the pending request; and (B) if the Director fails to issue such proposed order within the timeframe applicable under paragraph (4), transmit the pending request to the Commissioner of Food and Drugs for review. (4) Timeframe for issuance of proposed order by CDER The Director of the Center for Drug Evaluation and Research shall issue a proposed order, as required by paragraph (3)(A)— (A) 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 Act, not later than 45 days after such date of enactment; and (B) 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 Act, not later than 90 days after such date of enactment. (5) Proposed order by Commissioner With respect to a pending request transmitted to the Commissioner of Food and Drugs under paragraph (3)(B), the Commissioner shall, not later than 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. . 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. (b) Submissions pending issuance of final guidance Irrespective 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.

Passed the House of Representatives July 28, 2014. Karen L. Haas, Clerk.

tv_txt: II 113th CONGRESS 2d Session H. R. 4250 IN THE SENATE OF THE UNITED STATES July 29, 2014 Received AN ACT 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. Short title This Act may be cited as the Sunscreen Innovation Act . 2. Regulation of nonprescription sunscreen active ingredients 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: I Nonprescription sunscreen active ingredients 586. Definitions In this subchapter: (1) The term Advisory Committee means the Nonprescription Drug Advisory Committee or any successor to such Committee. (2) 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 suggested in the product’s labeling, as described in section 201(p). (3) The term GRASE determination means, with respect to a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, 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 prescribed, recommended, or suggested in the product’s labeling, as described in section 201(p). (4) The term nonprescription means not subject to section 503(b)(1). (5) The term pending request means each request submitted to the Secretary— (A) for consideration for inclusion in the over-the-counter drug monograph system; (B) 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 Act; and (C) for which safety and effectiveness data has been submitted to the Secretary prior to such date of enactment. (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. (7) The term sunscreen active ingredient means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering radiation. (8) The term sunscreen means a product containing one or more sunscreen active ingredients. 586A. General provisions (a) 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 ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is generally recognized as safe and effective and not misbranded. (b) Rules of construction (1) 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 subchapter. (2) 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 effectiveness. (3) Other products Nothing in this subchapter shall be construed to affect the Secretary’s regulation of products other than sunscreens. (c) Sunset This subchapter shall cease to be effective at the end of the 5-year period beginning on the date of enactment of this subchapter. 586B. Eligibility determination (a) In general Upon receipt of a request under section 586A(a), not later than 60 days after the date of receipt of such request, the Secretary shall— (1) determine whether the request is eligible for further review under sections 586C and 586D, as described in subsection (b); (2) notify the sponsor of the Secretary’s determination; and (3) make such determination publicly available in accordance with subsection (c). (b) Criteria for eligibility (1) In general To be eligible for review under sections 586C and 586D, a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof, that— (A) is not included in the stayed sunscreen monograph in part 352 of title 21, Code of Federal Regulations; and (B) has been used to a material extent and for a material time, as described in section 201(p)(2). (2) Time and extent application A sponsor shall include in a request under section 586A(a) a time and extent application including all the information required to meet the standard described in paragraph (1)(B). (c) Public availability (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 make the request 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 section 301(j) of this Act. (2) Identification of confidential information by sponsor Sponsors shall identify any information which the sponsor considers to be confidential information described in paragraph (1). (3) Confidentiality during eligibility review The information contained in a request under section 586A(a) shall remain confidential during the Secretary’s consideration under this section of whether the request is eligible for further review. 586C. Data submission; filing determination (a) In general In the case of a request under section 586A(a) that is determined to be eligible under section 586B for further review under this section and section 586D— (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— (A) 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 uses; or (B) any other comments; and (2) not later than 60 days after the submission of such data and other information by the sponsor, including any revised submission of such data and other information following a refusal to file under subparagraph (B), the Secretary shall— (A) (i) issue 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 (ii) file such request; or (B) 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 available; (3) the Secretary shall, in filing a request under paragraph (2)— (A) invite the public to submit further comments with respect to such filing; and (B) limit such public comment, and the comment period under paragraph (1), to the period ending on the date that is 60 days after such filing; (4) if the Secretary refuses to file the request— (A) the sponsor may, within 30 days of receipt of written notification of such refusal, seek a meeting with the Secretary regarding whether the Secretary should file the request; and (B) the Secretary shall convene the meeting; and (5) following any such meeting— (A) if the sponsor asks that the Secretary file the request (with or without amendments to correct any purported deficiencies to the request) the Secretary shall file the request over protest, issue a written notification of the filing to the sponsor, and make such notification publicly available; and (B) if the request is so filed over protest, the Secretary shall not require the sponsor to resubmit a copy of the request for purposes of such filing. (b) Reasons for refusal to file request The Secretary may refuse to file a request submitted under section 586A(a) 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 request. (c) Public availability (1) Redactions for confidential information The Secretary shall make data and other information submitted in connection with 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 section 301(j) of this Act. (2) 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 (1). 586D. GRASE determination (a) Review of new request (1) Proposed order by CDER In the case of a request under section 586A(a), the Director of the Center for Drug Evaluation and Research shall— (A) not later than 300 days after the date on which the request is filed under section 586C(a), complete the review of the request and issue a proposed order determining that— (i) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request— (I) is GRASE; and (II) is not misbranded; (ii) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request— (I) is not GRASE; or (II) is misbranded; or (iii) additional information is necessary to allow the Director of the Center for Drug Evaluation and Research to complete the review of such request; (B) within such 300-day period, convene a meeting of the Advisory Committee to review the request under section 586A(a); and (C) if the 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 Drugs for review. (2) Proposed order by Commissioner With respect to a request transmitted to the Commissioner of Food and Drugs under paragraph (1)(C), the Commissioner shall, not later than 60 days after the date of such transmission, issue— (A) a proposed order described in paragraph (1)(A)(i); (B) a proposed order described in paragraph (1)(A)(ii); or (C) a proposed order described in paragraph (1)(A)(iii). (3) Publication in Federal Register; public comment period A proposed order issued under paragraph (1) or (2) with respect to a request shall— (A) be published in the Federal Register; and (B) solicit public comments for a period of not more than 45 days. (4) Final order by CDER In the case of a proposed order under paragraph (1)(A) or (2) 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 (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 (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 (B) if the Director fails to issue such final order within such 90- or 210-day period, as applicable, transmit such proposed order to the Commissioner of Food and Drugs for review. (5) Final order by Commissioner With respect to a proposed order transmitted to the Commissioner of Food and Drugs under paragraph (4)(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. (b) Review of pending requests (1) 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 (3). (2) Inapplicability of certain provisions Sections 586B and 586C shall not apply with respect to any pending request. (3) Proposed order by CDER The Director of the Center for Drug Evaluation and Research shall— (A) within the timeframe applicable under paragraph (4), complete the review of the request and issue a proposed order determining that— (i) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request— (I) is GRASE; and (II) is not misbranded; (ii) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request— (I) is not GRASE; or (II) is misbranded; or (iii) additional information is necessary to allow the Director of the Center for Drug Evaluation and Research to complete the review of the pending request; and (B) if the Director fails to issue such proposed order within the timeframe applicable under paragraph (4), transmit the pending request to the Commissioner of Food and Drugs for review. (4) Timeframe for issuance of proposed order by CDER The Director of the Center for Drug Evaluation and Research shall issue a proposed order, as required by paragraph (3)(A)— (A) 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 Act, not later than 45 days after such date of enactment; and (B) 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 Act, not later than 90 days after such date of enactment. (5) Proposed order by Commissioner With respect to a pending request transmitted to the Commissioner of Food and Drugs under paragraph (3)(B), the Commissioner shall, not later than 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. . 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. (b) Submissions pending issuance of final guidance Irrespective 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.

Passed the House of Representatives July 28, 2014. Karen L. Haas, Clerk

tv_txt: IB Union Calendar No. 418 113th CONGRESS 2d Session H. R. 4250 [Report No. 113–558] IN THE HOUSE OF REPRESENTATIVES March 13, 2014 Mr. Whitfield (for himself and Mr. Dingell ) introduced the following bill; which was referred to the Committee on Energy and Commerce July 24, 2014 Additional sponsors: Mr. Farr , Mr. Guthrie , Mr. Tiberi , Mr. Stivers , Mr. Rogers of Kentucky , Mr. Barr , Mr. Forbes , Mr. Carney , Mr. Lance , Mrs. Ellmers , Mrs. Blackburn , Mrs. Carolyn B. Maloney of New York , Mr. Griffin of Arkansas , Mr. Crenshaw , Mr. Lankford , Mr. Dent , Mr. Rooney , Mr. Barrow of Georgia , Mr. Kingston , Mrs. Noem , Mr. Latta , Mr. Graves of Georgia , Mr. Ross , Mr. Bishop of New York , Mr. Perlmutter , Mr. Murphy of Pennsylvania , Mr. Diaz-Balart , Mr. Johnson of Ohio , Mr. Matheson , Mr. Roskam , Mr. Fleischmann , Mr. Chabot , and Mr. Renacci July 24, 2014 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on March 13, 2014 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. Short title This Act may be cited as the Sunscreen Innovation Act . 2. Regulation of nonprescription sunscreen active ingredients 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: I Nonprescription sunscreen active ingredients 586. Definitions In this subchapter: (1) The term Advisory Committee means the Nonprescription Drug Advisory Committee or any successor to such Committee. (2) 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 suggested in the product’s labeling, as described in section 201(p). (3) The term GRASE determination means, with respect to a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, 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 prescribed, recommended, or suggested in the product’s labeling, as described in section 201(p). (4) The term nonprescription means not subject to section 503(b)(1). (5) The term pending request means each request submitted to the Secretary— (A) for consideration for inclusion in the over-the-counter drug monograph system; (B) 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 Act; and (C) for which safety and effectiveness data has been submitted to the Secretary prior to such date of enactment. (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. (7) The term sunscreen active ingredient means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering radiation. (8) The term sunscreen means a product containing one or more sunscreen active ingredients. 586A. General provisions (a) 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 ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage form, dosage strength, and route of administration) is generally recognized as safe and effective and not misbranded. (b) Rules of construction (1) 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 subchapter. (2) 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 effectiveness. (3) Other products Nothing in this subchapter shall be construed to affect the Secretary’s regulation of products other than sunscreens. (c) Sunset This subchapter shall cease to be effective at the end of the 5-year period beginning on the date of enactment of this subchapter. 586B. Eligibility determination (a) In general Upon receipt of a request under section 586A(a), not later than 60 days after the date of receipt of such request, the Secretary shall— (1) determine whether the request is eligible for further review under sections 586C and 586D, as described in subsection (b); (2) notify the sponsor of the Secretary’s determination; and (3) make such determination publicly available in accordance with subsection (c). (b) Criteria for eligibility (1) In general To be eligible for review under sections 586C and 586D, a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof, that— (A) is not included in the stayed sunscreen monograph in part 352 of title 21, Code of Federal Regulations; and (B) has been used to a material extent and for a material time, as described in section 201(p)(2). (2) Time and extent application A sponsor shall include in a request under section 586A(a) a time and extent application including all the information required to meet the standard described in paragraph (1)(B). (c) Public availability (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 make the request 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 section 301(j) of this Act. (2) Identification of confidential information by sponsor Sponsors shall identify any information which the sponsor considers to be confidential information described in paragraph (1). (3) Confidentiality during eligibility review The information contained in a request under section 586A(a) shall remain confidential during the Secretary’s consideration under this section of whether the request is eligible for further review. 586C. Data submission; filing determination (a) In general In the case of a request under section 586A(a) that is determined to be eligible under section 586B for further review under this section and section 586D— (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— (A) 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 uses; or (B) any other comments; and (2) not later than 60 days after the submission of such data and other information by the sponsor, including any revised submission of such data and other information following a refusal to file under subparagraph (B), the Secretary shall— (A) (i) issue 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 (ii) file such request; or (B) 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 available; (3) the Secretary shall, in filing a request under paragraph (2)— (A) invite the public to submit further comments with respect to such filing; and (B) limit such public comment, and the comment period under paragraph (1), to the period ending on the date that is 60 days after such filing; (4) if the Secretary refuses to file the request— (A) the sponsor may, within 30 days of receipt of written notification of such refusal, seek a meeting with the Secretary regarding whether the Secretary should file the request; and (B) the Secretary shall convene the meeting; and (5) following any such meeting— (A) if the sponsor asks that the Secretary file the request (with or without amendments to correct any purported deficiencies to the request) the Secretary shall file the request over protest, issue a written notification of the filing to the sponsor, and make such notification publicly available; and (B) if the request is so filed over protest, the Secretary shall not require the sponsor to resubmit a copy of the request for purposes of such filing. (b) Reasons for refusal to file request The Secretary may refuse to file a request submitted under section 586A(a) 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 request. (c) Public availability (1) Redactions for confidential information The Secretary shall make data and other information submitted in connection with 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 section 301(j) of this Act. (2) 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 (1). 586D. GRASE determination (a) Review of new request (1) Proposed order by CDER In the case of a request under section 586A(a), the Director of the Center for Drug Evaluation and Research shall— (A) not later than 300 days after the date on which the request is filed under section 586C(a), complete the review of the request and issue a proposed order determining that— (i) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request— (I) is GRASE; and (II) is not misbranded; (ii) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the request— (I) is not GRASE; or (II) is misbranded; or (iii) additional information is necessary to allow the Director of the Center for Drug Evaluation and Research to complete the review of such request; (B) within such 300-day period, convene a meeting of the Advisory Committee to review the request under section 586A(a): and (C) if the 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 Drugs for review. (2) Proposed order by Commissioner With respect to a request transmitted to the Commissioner of Food and Drugs under paragraph (1)(C), the Commissioner shall, not later than 60 days after the date of such transmission, issue— (A) a proposed order described in paragraph (1)(A)(i); (B) a proposed order described in paragraph (1)(A)(ii); or (C) a proposed order described in paragraph (1)(A)(iii). (3) Publication in Federal Register; public comment period A proposed order issued under paragraph (1) or (2) with respect to a request shall— (A) be published in the Federal Register; and (B) solicit public comments for a period of not more than 45 days. (4) Final order by CDER In the case of a proposed order under paragraph (1)(A) or (2) 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 (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 (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 (B) if the Director fails to issue such final order within such 90- or 210-day period, as applicable, transmit such proposed order to the Commissioner of Food and Drugs for review. (5) Final order by Commissioner With respect to a proposed order transmitted to the Commissioner of Food and Drugs under paragraph (4)(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. (b) Review of pending requests (1) 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 (3). (2) Inapplicability of certain provisions Sections 586B and 586C shall not apply with respect to any pending request. (3) Proposed order by CDER The Director of the Center for Drug Evaluation and Research shall— (A) within the timeframe applicable under paragraph (4), complete the review of the request and issue a proposed order determining that— (i) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request— (I) is GRASE; and (II) is not misbranded; (ii) the nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that is the subject of the pending request— (I) is not GRASE; or (II) is misbranded; or (iii) additional information is necessary to allow the Director of the Center for Drug Evaluation and Research to complete the review of the pending request; and (B) if the Director fails to issue such proposed order within the timeframe applicable under paragraph (4), transmit the pending request to the Commissioner of Food and Drugs for review. (4) Timeframe for issuance of proposed order by CDER The Director of the Center for Drug Evaluation and Research shall issue a proposed order, as required by paragraph (3)(A)— (A) 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 Act, not later than 45 days after such date of enactment; and (B) 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 Act, not later than 90 days after such date of enactment. (5) Proposed order by Commissioner With respect to a pending request transmitted to the Commissioner of Food and Drugs under paragraph (3)(B), the Commissioner shall, not later than 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. . 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. (b) Submissions pending issuance of final guidance Irrespective 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.

July 24, 2014 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed