Sec. 101. Regulation of certain nonprescription drugs that are marketed without an approved new drug application
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Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505F ( 21 U.S.C. 355g ) the following: In this section: The term nonprescription drug means a drug, an active ingredient, or a combination of active ingredients that is not subject to section 503(b)(1). The term requestor means a person or group of persons marketing, manufacturing, processing, or developing a drug. The term sponsor means a person or group of persons marketing, manufacturing, or processing a drug and who has a listing in effect under section 510(j) for such drug.
With respect to a nonprescription drug that, on or after the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act , is introduced or delivered for introduction in interstate commerce for which an approved application under section 505 is not required, the following shall apply: A nonprescription drug is deemed to be generally recognized as safe and effective within the meaning of section 201(p)(1) and not a new drug under section 201(p) if— such drug is— subject to a final monograph issued under part 330 of title 21, Code of Federal Regulations, as of the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act ; in conformity with the conditions for nonprescription use of such monograph and the general requirements specified for nonprescription drugs, including any modifications to those conditions made under subsections (c), (d), and (j); and except as permitted by an administrative order issued under subsection
(c)or a minor change in the drug in conformity with subsection (d), is in a dosage form that has been used to a material extent and for a material time within the meaning of section 201(p)(2); or the subject of a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations, as of the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act ; classified in category I for safety and effectiveness under such tentative final monograph; in conformity with the conditions for nonprescription use of such tentative final monograph, any subsequent determination by the Secretary, and the general conditions for nonprescription drugs, including any modifications of those conditions under subsections (c), (d), and (j); and except as permitted by an administrative order issued under subsection
(c)or a minor change in the drug in conformity with subsection (d), is in a dosage form that has been used to a material extent and for a material time within the meaning of section 201(p)(2); or the active ingredient in such drug is in conformity with— the requirements of a final administrative order issued under subsection
(c)determining that such drug under the specific conditions of use is generally recognized as safe and effective within the meaning of section 201(p)(1); and the general requirements for nonprescription drugs, including any modifications of the requirements under subsections (c), (d), and (j); and such drug is— not classified in Category II for safety or effectiveness under a tentative final monograph; or determined by the Secretary to be not safe and effective, in a final monograph or preamble to a rule that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations. A nonprescription drug may be introduced into interstate commerce if such drug is— not classified in Category II for safety or effectiveness under a tentative final monograph; or determined by the Secretary to be not safe and effective, in a final monograph or preamble to a rule that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations; and the subject of a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations; classified in category III for safety or effectiveness in the preamble of a proposed rule establishing such tentative final monograph; in conformity with the most recently proposed or final rule establishing or proposing conditions of nonprescription use published in the Federal Register related to such tentative final monograph and the general requirements for nonprescription drugs, including any modifications of those requirements under subsections
(c)and (j); and in a dosage form that has been used to a material extent and for a material time within the meaning of section 201(p)(2); or the subject of a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations; classified in category I for safety and effectiveness under such proposed monograph or advance notice of proposed rulemaking; in conformity with the most recently proposed or final rule establishing or proposing conditions of nonprescription use published in the Federal Register related to such proposed monograph or advance notice of proposed rulemaking and the general requirements for nonprescription drugs, including any modifications of those requirements under subsections
(c)and (j); and in a dosage form that has been used to a material extent and for a material time within the meaning of section 201(p)(2). A nonprescription drug may be introduced into interstate commerce if— such drug is classified in category II for safety or effectiveness under a tentative final monograph, or the Secretary has determined such drug not to be safe and effective in a final monograph or preamble to a rule that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations; and the Secretary determines within 6 months of the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act , that it is in the interest of public health to extend the period during which the drug may be marketed without an approved new drug application under section 505. A drug that is subject to the final monograph for sunscreen drug products set forth at part 352 of title 21, Code of Federal Regulations (as published at volume 64 page 27687 of the Federal Register), shall comply with the requirements of that monograph, except that the testing requirements for effectiveness and the provisions governing labeling shall be in accordance with section 201.327 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act ), or such changes to those requirements as may be made under subsections (c), (d), and (j). A nonprescription drug is a new drug within the meaning of section 201(p) and subject to the requirements of section 505 if the drug is— not described in subparagraph (A), (B), or
(D)of paragraph
(1)and not in conformity with subsection (d); not subject to an administrative final order pursuant to subsection (c); or not a nonprescription sunscreen active ingredient or combination of ingredients subject to a final sunscreen order, as defined in section 586(2). A nonprescription drug that is in compliance with paragraph
(1)shall be referred to in this section as a monograph drug . This section shall not affect the treatment or status of a nonprescription drug subject to section 505— that, on the date of enactment of the Over-the-Counter Drug Safety, Innovation, and Reform Act , is marketed without an application approved under section 505; and to which subparagraphs (A), (B), (C), and
(D)of paragraph
(1)do not apply. Nothing in this paragraph shall be construed to preclude or limit the applicability of any other provision of this Act. Nothing in this subsection shall be construed to prohibit the Secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective. The Secretary may, on the initiative of the Secretary or at the request of one or more requestors, issue an administrative order determining whether there are requirements under which a specific drug, class of such drugs, or combination of such drugs is determined to be, after substantive review of evidence— not subject to section 503(b)(1); generally recognized as safe and effective within the meaning of section 201(p)(1); and not required to be approved under section 505. The Secretary shall issue an order determining that a drug is not generally recognized as safe and effective within the meaning of section 201(p)(1) for the specified requirements if, after substantive review of evidence, the Secretary determines that— the evidence shows that the drug is not generally recognized as safe and effective within the meaning of section 201(p)(1); or the evidence is inadequate to show that the drug is generally recognized as safe and effective within the meaning of section 201(p)(1). The requirements of subchapter II of chapter 5 of title 5, United States Code, shall not apply with respect to administrative orders issued under this section. Except as provided in paragraph (5), in issuing an administrative order under paragraph
(1)on the initiative of the Secretary, the Secretary shall— not later than 2 business days before issuance of the proposed order, informally communicate the pending issuance of the order to sponsors of drugs that will be subject to such order; after making any such informal communication— issue such a proposed administrative order by publishing it on the internet website of the Food and Drug Administration and include in such order the reasons for the issuance of such order; and publish notice of availability of such proposed order in the Federal Register; except as provided in subparagraph (B), provide for a public comment period with respect to such proposed order of not less than 45 calendar days; and if, after satisfying the requirements of clauses
(i)through (iii), the Secretary determines that it is appropriate to issue a final administrative order— issue the final administrative order, together with a detailed statement of reasons, but such order shall not take effect until the time for requesting judicial review under paragraph (4)(D)(ii) has expired; publish a notice of availability of such final administrative order in the Federal Register; afford requestors of products that will be subject to such order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which initially shall be requested within 45 calendar days of the issuance of the order, and, for subsequent levels of appeal, within 30 calendar days of the prior decision; and except with respect to drugs described in paragraph (4)(B), upon completion of the formal dispute resolution procedure, inform the person or persons which sought such dispute resolution of their right to request a hearing. When issuing an administrative order under paragraph
(1)on the initiative of the Secretary (except as provided under paragraph (5)) proposing to determine that a monograph drug described in subsection (b)(1)(B) is not generally recognized as safe and effective within the meaning of section 201(p)(1), the Secretary shall follow the procedures in subparagraph
(A)except that— the proposed order shall include notice of— the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective within the meaning of section 201(p)(1); and the format for submissions by interested persons; the Secretary shall provide for a public comment period of not less than 180 calendar days with respect to such proposed order, except when the Secretary determines, for good cause, that a shorter period is in the interest of public health; and any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective within the meaning of section 201(p)(1). The Secretary may issue an administrative order under paragraph
(1)in response to a citizen petition submitted under section 10.30 of title 21, Code of Federal Regulations (or any successor regulation), subject to clause (ii). Nothing in clause
(i)shall be construed to provide an alternative to, or otherwise supplant or supersede— the processes through which a requestor may seek an administrative order pursuant to paragraph (6); or the fee structure under section 744L–1(a)(2). A person who participated in each level of formal dispute resolution under paragraph (3)(A)(iv)(III) of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under paragraph (3)(A)(iv) with respect to such drug. Such person may submit a request for a hearing, which shall be based solely on the information in the administrative record, to the Secretary not later than 30 calendar days after receiving notice of the final decision of the formal dispute resolution procedure. The Secretary is not required to provide notice and an opportunity for a hearing pursuant to paragraph (3)(A)(iv) if the final administrative order involved relates to a drug— that is described in subclause
(I)or
(II)of subsection (b)(1)(B)(i); and with respect to which no data relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug (or, as applicable, since the deeming of such tentative final monograph as a final administrative order under paragraph (7)). If the Secretary determines that a request for a hearing under subparagraph
(A)with respect to a final administrative order issued under paragraph (3)(A)(iv), does not establish the existence of a genuine and substantial question of material fact, the Secretary may deny such request. In making such a determination, the Secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies. If more than one request for a hearing is submitted with respect to the same administrative order under subparagraph (A), the Secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate. The Secretary shall appoint a presiding officer of a hearing requested under subparagraph
(A)who— is not an employee of the Center for Drug Evaluation and Research; and has not previously been involved in the development of the applicable administrative order or in the proceedings relating to that administrative order. The parties to a hearing requested under subparagraph
(A)shall have the right to present testimony, including testimony of expert witnesses, and to cross-examine witnesses presented by other parties. Where appropriate, the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication. At the conclusion of a hearing requested under subparagraph (A), the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law. The decision of the presiding officer shall be final. The final decision may not take effect until the period under subparagraph (D)(ii) for submitting a request for judicial review of such decision expires. The procedures described in section 505(h) shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the United States in lieu of the appellate courts specified in such section. A person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file a request for such review not later than 60 calendar days after the latest of— the date on which notice of such order is published; the date on which any hearing with respect to such order is denied under subparagraph (C)(i); the date on which a final decision is made following any hearing with respect to such order under subparagraph (C)(v); or if no hearing is requested, the date on which the time for requesting a hearing expires. In the case of a determination by the Secretary that a monograph drug poses an imminent hazard to the public health, the Secretary may, after informally communicating with any sponsor that will be the subject of such determination, not later than 48 hours before issuance of an order under this subparagraph— issue an interim final administrative order for such drug or combination of drugs under paragraph (1), together with a detailed statement of the reasons for such order; publish in the Federal Register a notice of availability of such order; and provide for a public comment period of at least 45 calendar days after issuance of such interim final order. The Secretary may not delegate the authority to issue an interim final administrative order under this subparagraph. In the case of a determination by the Secretary that a change in the labeling of a drug, class of drugs, or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug, the Secretary may, after informally communicating with any sponsor that will be the subject of such determination, not later than 48 hours before issuance of an order under this subparagraph— issue an interim final administrative order in accordance with paragraph
(1)to require such change, together with a detailed statement of the reasons for such order; publish in the Federal Register a notice of availability of such order; and provide for a public comment period of at least 45 calendar days after issuance of such interim final order. An interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug. An order under subparagraph
(A)or
(B)shall take effect on a date specified by the Secretary, which date, in the case of an order under subparagraph
(B)that includes changes to the packaging of the drug, shall not be earlier than the day after the date on which the comment period described in subparagraph (B)(i)(III) ends. After the completion of the proceedings in subparagraph
(A)or (B), the Secretary shall— issue a final order in accordance with paragraph (1); publish a notice of availability of such final administrative order in the Federal Register; and afford sponsors of drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the Director of the Center for Drug Evaluation and Research, which initially shall be within 45 calendar days of the issuance of the order; and, for subsequent levels of appeal, within 30 calendar days of the prior decision. A sponsor of a drug subject to a final order issued under subparagraph
(D)who participated in each level of formal dispute resolution under subparagraph (D)(iii) may request a hearing on such order. The provisions of subparagraphs (A), (B), and
(C)of paragraph
(4)shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph (3)(A)(iv). For purposes of a hearing under this subparagraph, the references in subparagraphs (A), (B), and
(C)of paragraph (4)— to each level of dispute resolution under paragraph (3)(A)(iv)(III) shall be deemed to mean each level of formal dispute resolution under subparagraph (D)(iii) ; and to final administrative order issued under paragraph (3)(A)(iv) shall be deemed to mean final order under subparagraph (D)(i) . Not later than 1 year after the date on which an interim final order is issued under subparagraph
(A)or (B), the Secretary shall issue a final order in accordance with paragraph
(1)and complete any required hearing. A final order issued pursuant to subparagraph
(F)shall be subject to judicial review in accordance with paragraph (4)(D). Paragraph
(3)shall not apply to the orders issued under this paragraph. In issuing an administrative order under paragraph
(1)at the request of a requestor or a group of requestors with respect to certain drugs, classes of drugs, or combinations of drugs— the Secretary shall, after receiving a request under this subparagraph, determine whether the request is sufficiently complete and formatted to permit a substantive review; subject to subparagraph (D), if the Secretary determines that the request is sufficiently complete and formatted to permit a substantive review, the Secretary shall— file the request; and initiate proceedings with respect to issuing an administrative order in accordance with paragraphs
(3)and (4); and except as provided in subparagraph (D)(v), if the Secretary determines that a request does not meet the requirements for filing or is not sufficiently complete or formatted to permit a substantive review, the requestor may elect that the Secretary file the request over protest, and the Secretary shall initiate proceedings to review the request in accordance with paragraph (3)(A). A requestor seeking an administrative order with respect to certain drugs, classes of drugs, or combinations of drugs, shall submit to the Secretary a request to initiate proceedings for such order in the form and manner as specified by the Secretary. Such requestor may submit a request under this subparagraph for the issuance of an administrative order— determining whether a drug is generally recognized as safe and effective within the meaning of section 201(p)(1), exempt from section 503(b)(1), and not required to be the subject of an approved application under section 505; or determining whether a change to a condition of use or a new condition of use of a drug is generally recognized as safe and effective within the meaning of section 201(p)(1), exempt from section 503(b)(1), and not required to be the subject of an approved application under section 505, if such drug is— described in subsection (b)(1)(A); or described in subsection (b)(1)(B), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective within the meaning of section 201(p)(1), which is filed by the Secretary under subparagraph (A)(ii)(I). The Secretary is not required to complete review of the request for a change described in subclause
(II)if the Secretary determines, in accordance with subparagraph (D), that there is an inadequate basis to find the drug is generally recognized as safe and effective under paragraph
(1)and issues a final order announcing that determination. The requestor may withdraw a request under this paragraph, according to the procedures established by the Secretary. Notwithstanding any other provision of this section, if such request is withdrawn, the Secretary shall cease proceedings under this subparagraph. A final administrative order issued in response to a request under this paragraph shall have the effect of providing the order requestor (or the licensees, assignees, or successors in interest of such requestor with respect to the subject of such order and listed under clause (v)) the exclusive right, for a period of 2 years, to market drugs under this section incorporating changes described in clause (ii), subject to the limitations under clause (iv), and beginning on the date the requestor (or any such licensees, assignees, or successors in interest of such requestor) may lawfully market such drugs pursuant to the order. A change described in this clause is a change subject to an order specified in clause (i), which— permits a drug to contain an active ingredient not previously incorporated in a marketed drug listed in clause (iii); or permits a change in the conditions of use of a drug, for which human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order. The marketed drugs listed in this clause are drugs— marketed in accordance with a final monograph issued under part 330 of title 21, Code of Federal Regulations (including conditions of use thereunder), as in effect on the day before the date of enactment of this section; marketed as category I or III in accordance with a tentative final monograph issued under such part 330 (including conditions of use and any applicable subsequent determinations thereunder), as so in effect; marketed as category I in accordance with an advance notice of proposed rulemaking issued under such part 330 (including conditions of use and any applicable subsequent determinations thereunder), as so in effect; marketed in accordance with a final order issued under this section; or described in subsection (b)(1)(C), other than drugs subject to an active enforcement action under section 303. Only one 2-year period may be granted per drug under clause
(i)with respect to any change described in clause (ii). No period of product differentiation under this subparagraph shall apply to changes to a drug that are— Tier 2 changes described in section 744L(14)(A); safety-related changes described in section 744L–1(a)(2)(C), required under paragraph (5), or any other change the Secretary determines necessary to ensure safe use; or changes related to methods of testing safety or efficacy. The requestors of an order described in clause
(i)shall, as applicable, submit to the Secretary, at a time when a finished dosage form subject to such order is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest that have the exclusive right described in such clause. For purposes of this subparagraph, the term human data means data from clinical trials of safety or effectiveness, or pharmacokinetics or bioavailability studies. In response to a request under this paragraph that a drug described in clause
(ii)be generally recognized as safe and effective, the Secretary— may file such request, if the request includes information specified under clause
(iii)with respect to safe nonprescription marketing and use of such drug; or if the request fails to include information specified under clause (iii), shall refuse to file such request and may require that nonprescription marketing of the drug be pursuant to a new drug application as described in clause (iv). A drug described in this clause is a monograph drug that contains an active ingredient not previously incorporated in a drug— marketed in accordance with a final monograph issued under part 330 of title 21, Code of Federal Regulations (including conditions of use under such part), as in effect on the day before the date of enactment of this section; marketed as category I in accordance with a tentative final monograph issued under part 330 of title 21, Code of Federal Regulations (including conditions of use and any applicable subsequent determinations under such part), as in effect on the day before the date of enactment of this section; or marketed in accordance with a final order issued under this section. Information specified in this subparagraph, with respect to a request described in clause (i)(I), is— information sufficient for a threshold demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the United States as a nonprescription drug under comparable conditions of use; if the drug has not been previously marketed in the United States as a nonprescription drug, information sufficient for a threshold demonstration that the drug was marketed and safely used in a foreign country under conditions of marketing and use— for such period of time as needed to provide reasonable assurances concerning the safe nonprescription use of the drug; and during such period of time, was subject to sufficient monitoring by a regulatory body of any country listed in section 802(b)(1)(A) or any country designated by the Secretary in accordance with section 802(b)(1)(B); or if the Secretary determines that information described in subclause
(I)or
(II)is not needed to provide a threshold demonstration that the drug can be safely marketed and used as a nonprescription drug, other information the Secretary determines sufficient for such purposes. In the case of a request described in clause (i)(II), the drug subject to such request may be re-submitted for filing only if— the drug is marketed as a nonprescription drug, under conditions of use comparable to the requirements specified in the request, for such period of the time as the Secretary determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under section 505; and during such period of time, 1,000,000 retail packages of the drug, or an equivalent quantity of the active ingredient or ingredients of such drug as determined by the Secretary, were distributed for retail sale, as determined in such manner as the Secretary may require. If the Secretary refuses to file a request under this subparagraph, the requestor may not file over protest under subparagraph (A)(iii) unless the request involves a drug described in section 586(9) as in effect on January 1, 2017. A final monograph or tentative final monograph establishing requirements of use for a drug described in subsection (b)(1) shall be deemed to be a final administrative order under this subsection and may be amended, revoked, or otherwise modified in accordance with the procedures of this subsection. An administrative order issued under paragraph (3), (5)(A), or
(6)may include requirements for the packaging of a drug, such as to promote use in accordance with labeling, unit dose packaging, or requirements to prevent accidental overdose or ingestion, misuse, or abuse, including by pediatric populations. The Secretary shall consider, as appropriate, any such nonprescription drugs currently available, and the impact of the removal of such drugs without such packaging and the changing of such packaging on patients and manufacturers when establishing such requirements. Requirements for packaging in an administrative order under paragraph (5)(B) shall not take effect earlier than the day after the date on which the comment period under paragraph (5)(B)(i)(III) ends. This paragraph does not authorize the Secretary to require special packaging or child-resistant packaging under the Poison Prevention Packaging Act of 1970. Minor changes in the dosage form of a drug that is described in clause (i)(I)(aa)(CC) or
(ii)of subsection (b)(1)(A) may be made by a requestor without the issuance of an administrative order under subsection
(c)if— the requestor maintains information necessary to demonstrate that the change— will not affect the safety or effectiveness of the drug; and will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product; the requestor submits updated drug listing information for the drug in accordance with the requirements of section 510(j) within 30 calendar days of the date on which the drug is first introduced into interstate commerce with the change; and the change is in conformity with the requirements of an applicable administrative order issued by the Secretary under paragraph (3). The requestor shall submit to the Secretary, under section 704(a)(4), records requested by the Secretary related to a minor change within 15 business days of receiving such request, or such longer period as the Secretary may provide. Such request shall be specific to a company and limited to the product and the minor change that prompted such request. Such request shall be specific to a company and limited to the product and the minor change that prompted such request. If the Secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient, the Secretary— may so inform the requestor of the drug in writing; and provide the requestor of the drug with a reasonable opportunity to provide additional information. If the requestor fails to provide such additional information within the prescribed time, or if the Secretary determines that such additional information does not demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient, the drug as modified is a new drug within the meaning of section 201(p) and shall be deemed to be misbranded under section 502(ee). The Secretary shall issue one or more administrative orders under subsection
(c)specifying requirements for determining whether a minor change made by a requestor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product, together with guidance for applying those orders to specific dosage forms. The orders and guidance issued by the Secretary under subparagraph
(A)shall take into account relevant public standards and standard practices for evaluating the quality of drug products and may take into account special needs of populations, including children. Any information, including reports of testing conducted on the drug or drugs involved, that is submitted by a requestor in connection with proceedings on an administrative order under this section (or any minor change under subsection (d)) and is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code, shall not be disclosed to the public unless the requestor consents to that disclosure. The Secretary shall make available to the public any information (other than information contained in subject-level data sets, such as those derived from individual case report forms) submitted by a requestor in support of a request under subsection (c)(6)(A) as of the date on which the proposed order is issued unless— the information pertains to pharmaceutical quality, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective within the meaning of section 201(p)(1); the information is submitted in a requestor-initiated request, but the requestor withdraws such request before the Secretary issues the proposed order in accordance with withdrawal procedures established by the Secretary; or the Secretary otherwise obtains the information under subsection (d). The Secretary shall establish, maintain, update (as the Secretary determines necessary, but not less frequently than annually), and make available on the internet website of the Food and Drug Administration— a repository of each final administrative order and interim final order issued under subsection
(c)that is in effect, including the complete text of the administrative order; and a listing of all administrative orders proposed and under development on the initiative of the Secretary under this section, including— a brief description of the administrative order; and the expectations of the Secretary, for issuance of proposed administrative orders over a 3-year period. A sponsor who makes a change to a drug other than a change in dosage form, which is in conformity with the requirements under subparagraph
(A)or
(B)of subsection (b)(1), shall not be subject to the requirements of subsection
(c)or
(d)with respect to such change, and shall submit updated drug listing information for the drug in accordance with the requirements of section 510(j) within 30 calendar days of the date on which the drug, with the change, is first introduced or delivered for introduction into interstate commerce. This section shall not be construed to preclude a sponsor of a drug or requestor from seeking or maintaining the approval of an application for such drug under subsection (b)(1), (b)(2), or
(j)of section 505. A determination under this section that a drug is not subject to section 503(b)(1), is generally recognized as safe and effective within the meaning of section 201(p)(1), and is not a new drug under section 201(p), shall constitute a finding of safety and effectiveness for purposes of section 505(b)(2) so that the applicant shall be required to submit only that information needed to support the modification of the drug that is subject to the determination under this section. The Secretary shall establish procedures under which requestors may meet with appropriate officials of the Food and Drug Administration to obtain advice on the studies and other information necessary to support requests under this section and other matters relevant to the regulation of monograph drugs and the development of new monograph drugs under this section. The Secretary shall establish procedures to facilitate efficient participation by multiple requestors in proceedings under this section, including provision for joint meetings with multiple requestors or with organizations nominated by requestors to represent their interests in a proceeding. The procedures established under this subsection shall include appropriate provision for confidential meetings with requestors with respect to discussion of matters involving confidential commercial information or trade secrets. Except as provided in this subsection, nothing in this section supersedes regulations establishing general requirements for nonprescription drugs, including regulations of general applicability contained in parts 201, 250, and 330 of title 21, Code of Federal Regulations, or any successor regulations. The Secretary shall establish or modify such regulations by means of rulemaking in accordance with section 553 of title 5, United States Code. Section 310.545 of title 21, Code of Federal Regulations, as in effect on the date of enactment of this section, shall be deemed to be final administrative order under subsection (c). Regulations establishing requirements for specific nonprescription drugs marketed pursuant to this section that are in effect on the day before the date of enactment of this section (including such requirements in parts 201, 250, and 330 of title 21, Code of Federal Regulations), shall be deemed to be final administrative orders under subsection
(c)only as such requirements apply to monograph drugs. Unless withdrawn or revised by the Secretary, the regulations under title 21 of the Code of Federal Regulations that are described in subparagraph
(B)shall remain in effect with respect to drugs not subject to subparagraph (A), (B), (C), or
(D)of subsection (b)(1). The Secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part 330 and other relevant parts of title 21, Code of Federal Regulations (as in effect on the day before the date of enactment of this Act), or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references, to the extent needed to effectuate or harmonize the provisions of this section. Notwithstanding subchapter II of chapter 5 of title 5, United States Code, any such withdrawal or technical amendments shall be made without public notice and comment and be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice). The Secretary shall issue guidance that provides— the procedures and principles for formal meetings between the Secretary and sponsors or requestors for drugs subject to this section; the format and content of data submissions to the Secretary under this section; the format of electronic submissions to the Secretary under this section; consolidated proceedings and the procedures for such proceedings where appropriate; and for minor changes in drugs, recommendations on how to comply with the requirements in administrative orders issued under subsection (c)(3). All submissions under this section shall be in an electronic format specified by the Secretary after providing a period for public comment. Chapter 35 of title 44, United States Code, shall not apply to collections of information made under this section. .
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Sec. 101
Regulation of certain nonprescription drugs that are marketed without an approved new drug application
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