[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2315 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 413
115th CONGRESS
  2d Session
                                S. 2315

   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
regulatory framework with respect to certain nonprescription drugs that 
 are marketed without an approved new drug application, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 17, 2018

 Mr. Isakson (for himself, Mr. Casey, Mr. Alexander, and Mrs. Murray) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                              May 14, 2018

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
regulatory framework with respect to certain nonprescription drugs that 
 are marketed without an approved new drug application, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the ``Over-the-
Counter Drug Safety, Innovation, and Reform Act''.</DELETED>
<DELETED>    (b) Table of Contents.--The table of contents for this Act 
is as follows:</DELETED>

<DELETED>Sec. 1. Short title; table of contents.
         <DELETED>TITLE I--REGULATION OF NONPRESCRIPTION DRUGS

<DELETED>Sec. 101. Regulation of certain nonprescription drugs that are 
                            marketed without an approved new drug 
                            application.
<DELETED>Sec. 102. Misbranding.
<DELETED>Sec. 103. Conforming amendments to the Sunscreen Innovation 
                            Act.
<DELETED>Sec. 104. Drugs excluded from over-the-counter review.
<DELETED>Sec. 105. Conforming amendment.
<DELETED>Sec. 106. Annual update to Congress on appropriate pediatric 
                            indication for certain cough and cold 
                            monograph drugs.
          <DELETED>TITLE II--FEES RELATING TO MONOGRAPH DRUGS

<DELETED>Sec. 201. Short title; findings.
<DELETED>Sec. 202. Authority to access and use fees.

    <DELETED>TITLE I--REGULATION OF NONPRESCRIPTION DRUGS</DELETED>

<DELETED>SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE 
              MARKETED WITHOUT AN APPROVED NEW DRUG 
              APPLICATION.</DELETED>

<DELETED>    Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 505F (21 U.S.C. 355g) the 
following:</DELETED>

<DELETED>``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT 
              ARE MARKETED WITHOUT AN APPROVED NEW DRUG 
              APPLICATION.</DELETED>

<DELETED>    ``(a) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Nonprescription drug.--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).</DELETED>
        <DELETED>    ``(2) Requestor.--The term `requestor' means a 
        person or group of persons marketing, manufacturing, 
        processing, or developing a drug.</DELETED>
        <DELETED>    ``(3) Sponsor.--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.</DELETED>
<DELETED>    ``(b) Monograph Drugs.--</DELETED>
        <DELETED>    ``(1) In general.--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:</DELETED>
                <DELETED>    ``(A) 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--</DELETED>
                        <DELETED>    ``(i)(I) such drug is--</DELETED>
                                        <DELETED>    ``(aa)(AA) 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;</DELETED>
                                        <DELETED>    ``(BB) 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</DELETED>
                                        <DELETED>    ``(CC) 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</DELETED>
                                        <DELETED>    ``(bb)(AA) 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;</DELETED>
                                        <DELETED>    ``(BB) classified 
                                        in category I for safety and 
                                        effectiveness under such 
                                        tentative final 
                                        monograph;</DELETED>
                                        <DELETED>    ``(CC) 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</DELETED>
                                        <DELETED>    ``(DD) 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</DELETED>
                        <DELETED>    ``(II) the active ingredient in 
                        such drug is in conformity with--</DELETED>
                                <DELETED>    ``(aa) 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</DELETED>
                                <DELETED>    ``(bb) the general 
                                requirements for nonprescription drugs, 
                                including any modifications of the 
                                requirements under subsections (c), 
                                (d), and (j); and</DELETED>
                        <DELETED>    ``(ii) such drug is--</DELETED>
                                <DELETED>    ``(I) not classified in 
                                Category II for safety or effectiveness 
                                under a tentative final monograph; 
                                or</DELETED>
                                <DELETED>    ``(II) 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.</DELETED>
                <DELETED>    ``(B) A nonprescription drug may be 
                introduced into interstate commerce if such drug is--
                </DELETED>
                        <DELETED>    ``(i)(I) not classified in 
                        Category II for safety or effectiveness under a 
                        tentative final monograph; or</DELETED>
                        <DELETED>    ``(II) 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</DELETED>
                        <DELETED>    ``(ii)(I)(aa) 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;</DELETED>
                        <DELETED>    ``(bb) classified in category III 
                        for safety or effectiveness in the preamble of 
                        a proposed rule establishing such tentative 
                        final monograph;</DELETED>
                        <DELETED>    ``(cc) 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</DELETED>
                        <DELETED>    ``(dd) 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</DELETED>
                        <DELETED>    ``(II)(aa) 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;</DELETED>
                        <DELETED>    ``(bb) classified in category I 
                        for safety and effectiveness under such 
                        proposed monograph or advance notice of 
                        proposed rulemaking;</DELETED>
                        <DELETED>    ``(cc) 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</DELETED>
                        <DELETED>    ``(dd) 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).</DELETED>
                <DELETED>    ``(C) A nonprescription drug may be 
                introduced into interstate commerce if--</DELETED>
                        <DELETED>    ``(i) 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</DELETED>
                        <DELETED>    ``(ii) 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.</DELETED>
                <DELETED>    ``(D) 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).</DELETED>
        <DELETED>    ``(2) New drugs.--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--</DELETED>
                <DELETED>    ``(A) not described in subparagraph (A), 
                (B), or (D) of paragraph (1) and not in conformity with 
                subsection (d);</DELETED>
                <DELETED>    ``(B) not subject to an administrative 
                final order pursuant to subsection (c); or</DELETED>
                <DELETED>    ``(C) not a nonprescription sunscreen 
                active ingredient or combination of ingredients subject 
                to a final sunscreen order, as defined in section 
                586(2).</DELETED>
        <DELETED>    ``(3) Monograph drug.--A nonprescription drug that 
        is in compliance with paragraph (1) shall be referred to in 
        this section as a `monograph drug'.</DELETED>
        <DELETED>    ``(4) Rules of construction.--</DELETED>
                <DELETED>    ``(A) In general.--This section shall not 
                affect the treatment or status of a nonprescription 
                drug subject to section 505--</DELETED>
                        <DELETED>    ``(i) 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</DELETED>
                        <DELETED>    ``(ii) to which subparagraphs (A), 
                        (B), (C), and (D) of paragraph (1) do not 
                        apply.</DELETED>
                <DELETED>    ``(B) Applicability of other provisions.--
                Nothing in this paragraph shall be construed to 
                preclude or limit the applicability of any other 
                provision of this Act.</DELETED>
                <DELETED>    ``(C) No effect on other authorities.--
                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.</DELETED>
<DELETED>    ``(c) Administrative Orders.--</DELETED>
        <DELETED>    ``(1) In general.--</DELETED>
                <DELETED>    ``(A) 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--</DELETED>
                        <DELETED>    ``(i) not subject to section 
                        503(b)(1);</DELETED>
                        <DELETED>    ``(ii) generally recognized as 
                        safe and effective within the meaning of 
                        section 201(p)(1); and</DELETED>
                        <DELETED>    ``(iii) not required to be 
                        approved under section 505.</DELETED>
                <DELETED>    ``(B) Not generally recognized as safe and 
                effective.--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--</DELETED>
                        <DELETED>    ``(i) the evidence shows that the 
                        drug is not generally recognized as safe and 
                        effective within the meaning of section 
                        201(p)(1); or</DELETED>
                        <DELETED>    ``(ii) the evidence is inadequate 
                        to show that the drug is generally recognized 
                        as safe and effective within the meaning of 
                        section 201(p)(1).</DELETED>
        <DELETED>    ``(2) Nonapplication of certain requirements.--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.</DELETED>
        <DELETED>    ``(3) Administrative orders initiated by the 
        secretary; citizen petitions.--</DELETED>
                <DELETED>    ``(A) In general.--Except as provided in 
                paragraph (5), in issuing an administrative order under 
                paragraph (1) on the initiative of the Secretary, the 
                Secretary shall--</DELETED>
                        <DELETED>    ``(i) 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;</DELETED>
                        <DELETED>    ``(ii) after making any such 
                        informal communication--</DELETED>
                                <DELETED>    ``(I) 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</DELETED>
                                <DELETED>    ``(II) publish notice of 
                                availability of such proposed order in 
                                the Federal Register;</DELETED>
                        <DELETED>    ``(iii) 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</DELETED>
                        <DELETED>    ``(iv) if, after satisfying the 
                        requirements of clauses (i) through (iii), the 
                        Secretary determines that it is appropriate to 
                        issue a final administrative order--</DELETED>
                                <DELETED>    ``(I) 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;</DELETED>
                                <DELETED>    ``(II) publish a notice of 
                                availability of such final 
                                administrative order in the Federal 
                                Register;</DELETED>
                                <DELETED>    ``(III) 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</DELETED>
                                <DELETED>    ``(IV) 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.</DELETED>
                <DELETED>    ``(B) Special requirements with respect to 
                certain monograph drugs.--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--</DELETED>
                        <DELETED>    ``(i) the proposed order shall 
                        include notice of--</DELETED>
                                <DELETED>    ``(I) 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</DELETED>
                                <DELETED>    ``(II) the format for 
                                submissions by interested 
                                persons;</DELETED>
                        <DELETED>    ``(ii) 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</DELETED>
                        <DELETED>    ``(iii) 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).</DELETED>
                <DELETED>    ``(C) Citizen petitions.--</DELETED>
                        <DELETED>    ``(i) In general.--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).</DELETED>
                        <DELETED>    ``(ii) Effect of petition.--
                        Nothing in clause (i) shall be construed to 
                        provide an alternative to, or otherwise 
                        supplant or supersede--</DELETED>
                                <DELETED>    ``(I) the processes 
                                through which a requestor may seek an 
                                administrative order pursuant to 
                                paragraph (6); or</DELETED>
                                <DELETED>    ``(II) the fee structure 
                                under section 744L-1(a)(2).</DELETED>
        <DELETED>    ``(4) Hearings; judicial review.--</DELETED>
                <DELETED>    ``(A) In general.--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.</DELETED>
                <DELETED>    ``(B) No hearing required with respect to 
                orders relating to certain drugs.--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--
                </DELETED>
                        <DELETED>    ``(i) that is described in 
                        subclause (I) or (II) of subsection 
                        (b)(1)(B)(i); and</DELETED>
                        <DELETED>    ``(ii) 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)).</DELETED>
                <DELETED>    ``(C) Hearing procedures.--</DELETED>
                        <DELETED>    ``(i) Denial of request for 
                        hearing.--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.</DELETED>
                        <DELETED>    ``(ii) Single hearing for multiple 
                        related requests.--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.</DELETED>
                        <DELETED>    ``(iii) Presiding officer.--The 
                        Secretary shall appoint a presiding officer of 
                        a hearing requested under subparagraph (A) 
                        who--</DELETED>
                                <DELETED>    ``(I) is not an employee 
                                of the Center for Drug Evaluation and 
                                Research; and</DELETED>
                                <DELETED>    ``(II) has not previously 
                                been involved in the development of the 
                                applicable administrative order or in 
                                the proceedings relating to that 
                                administrative order.</DELETED>
                        <DELETED>    ``(iv) Rights of parties to 
                        hearing.--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.</DELETED>
                        <DELETED>    ``(v) Final decision.--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.</DELETED>
                <DELETED>    ``(D) Judicial review of final 
                administrative order.--</DELETED>
                        <DELETED>    ``(i) In general.--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.</DELETED>
                        <DELETED>    ``(ii) Time to submit a request 
                        for judicial review.--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--</DELETED>
                                <DELETED>    ``(I) the date on which 
                                notice of such order is 
                                published;</DELETED>
                                <DELETED>    ``(II) the date on which 
                                any hearing with respect to such order 
                                is denied under subparagraph 
                                (C)(i);</DELETED>
                                <DELETED>    ``(III) the date on which 
                                a final decision is made following any 
                                hearing with respect to such order 
                                under subparagraph (C)(v); or</DELETED>
                                <DELETED>    ``(IV) if no hearing is 
                                requested, the date on which the time 
                                for requesting a hearing 
                                expires.</DELETED>
        <DELETED>    ``(5) Expedited procedure with respect to 
        administrative orders initiated by the secretary.--</DELETED>
                <DELETED>    ``(A) Imminent hazard to the public 
                health.--</DELETED>
                        <DELETED>    ``(i) In general.--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--</DELETED>
                                <DELETED>    ``(I) 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;</DELETED>
                                <DELETED>    ``(II) publish in the 
                                Federal Register a notice of 
                                availability of such order; 
                                and</DELETED>
                                <DELETED>    ``(III) provide for a 
                                public comment period of at least 45 
                                calendar days after issuance of such 
                                interim final order.</DELETED>
                        <DELETED>    ``(ii) Nondelegation.--The 
                        Secretary may not delegate the authority to 
                        issue an interim final administrative order 
                        under this subparagraph.</DELETED>
                <DELETED>    ``(B) Safety labeling changes.--</DELETED>
                        <DELETED>    ``(i) In general.--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--
                        </DELETED>
                                <DELETED>    ``(I) 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;</DELETED>
                                <DELETED>    ``(II) publish in the 
                                Federal Register a notice of 
                                availability of such order; 
                                and</DELETED>
                                <DELETED>    ``(III) provide for a 
                                public comment period of at least 45 
                                calendar days after issuance of such 
                                interim final order.</DELETED>
                        <DELETED>    ``(ii) Content of 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.</DELETED>
                <DELETED>    ``(C) Effective date.--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.</DELETED>
                <DELETED>    ``(D) Final order.--After the completion 
                of the proceedings in subparagraph (A) or (B), the 
                Secretary shall--</DELETED>
                        <DELETED>    ``(i) issue a final order in 
                        accordance with paragraph (1);</DELETED>
                        <DELETED>    ``(ii) publish a notice of 
                        availability of such final administrative order 
                        in the Federal Register; and</DELETED>
                        <DELETED>    ``(iii) 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.</DELETED>
                <DELETED>    ``(E) Hearings.--</DELETED>
                        <DELETED>    ``(i) In general.--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).</DELETED>
                        <DELETED>    ``(ii) References.--For purposes 
                        of a hearing under this subparagraph, the 
                        references in subparagraphs (A), (B), and (C) 
                        of paragraph (4)--</DELETED>
                                <DELETED>    ``(I) 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</DELETED>
                                <DELETED>    ``(II) to `final 
                                administrative order issued under 
                                paragraph (3)(A)(iv)' shall be deemed 
                                to mean `final order under subparagraph 
                                (D)(i)'.</DELETED>
                <DELETED>    ``(F) Final order.--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.</DELETED>
                <DELETED>    ``(G) Judicial review.--A final order 
                issued pursuant to subparagraph (F) shall be subject to 
                judicial review in accordance with paragraph 
                (4)(D).</DELETED>
                <DELETED>    ``(H) Clarification.--Paragraph (3) shall 
                not apply to the orders issued under this 
                paragraph.</DELETED>
        <DELETED>    ``(6) Administrative order initiated by request.--
        </DELETED>
                <DELETED>    ``(A) In general.--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--</DELETED>
                        <DELETED>    ``(i) the Secretary shall, after 
                        receiving a request under this subparagraph, 
                        determine whether the request is sufficiently 
                        complete and formatted to permit a substantive 
                        review;</DELETED>
                        <DELETED>    ``(ii) subject to subparagraph 
                        (D), if the Secretary determines that the 
                        request is sufficiently complete and formatted 
                        to permit a substantive review, the Secretary 
                        shall--</DELETED>
                                <DELETED>    ``(I) file the request; 
                                and</DELETED>
                                <DELETED>    ``(II) initiate 
                                proceedings with respect to issuing an 
                                administrative order in accordance with 
                                paragraphs (3) and (4); and</DELETED>
                        <DELETED>    ``(iii) 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).</DELETED>
                <DELETED>    ``(B) Request to initiate proceedings.--
                </DELETED>
                        <DELETED>    ``(i) In general.--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--</DELETED>
                                <DELETED>    ``(I) 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</DELETED>
                                <DELETED>    ``(II) 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--</DELETED>
                                        <DELETED>    ``(aa) described 
                                        in subsection (b)(1)(A); 
                                        or</DELETED>
                                        <DELETED>    ``(bb) 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).</DELETED>
                        <DELETED>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.</DELETED>
                        <DELETED>    ``(ii) Withdrawal of request.--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.</DELETED>
                <DELETED>    ``(C) Product differentiation.--</DELETED>
                        <DELETED>    ``(i) In general.--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.</DELETED>
                        <DELETED>    ``(ii) Changes described.--A 
                        change described in this clause is a change 
                        subject to an order specified in clause (i), 
                        which--</DELETED>
                                <DELETED>    ``(I) permits a drug to 
                                contain an active ingredient not 
                                previously incorporated in a marketed 
                                drug listed in clause (iii); 
                                or</DELETED>
                                <DELETED>    ``(II) 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.</DELETED>
                        <DELETED>    ``(iii) Marketed drugs.--The 
                        marketed drugs listed in this clause are 
                        drugs--</DELETED>
                                <DELETED>    ``(I) 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;</DELETED>
                                <DELETED>    ``(II) 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;</DELETED>
                                <DELETED>    ``(III) 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;</DELETED>
                                <DELETED>    ``(IV) marketed in 
                                accordance with a final order issued 
                                under this section; or</DELETED>
                                <DELETED>    ``(V) described in 
                                subsection (b)(1)(C), other than drugs 
                                subject to an active enforcement action 
                                under section 303.</DELETED>
                        <DELETED>    ``(iv) Limitations on product 
                        differentiation.--</DELETED>
                                <DELETED>    ``(I) Only one period.--
                                Only one 2-year period may be granted 
                                per drug under clause (i) with respect 
                                to any change described in clause 
                                (ii).</DELETED>
                                <DELETED>    ``(II) Exclusions.--No 
                                period of product differentiation under 
                                this subparagraph shall apply to 
                                changes to a drug that are--</DELETED>
                                        <DELETED>    ``(aa) `Tier 2' 
                                        changes described in section 
                                        744L(14)(A);</DELETED>
                                        <DELETED>    ``(bb) 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</DELETED>
                                        <DELETED>    ``(cc) changes 
                                        related to methods of testing 
                                        safety or efficacy.</DELETED>
                        <DELETED>    ``(v) Listing of licensees, 
                        assignees, or successors in interest.--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.</DELETED>
                        <DELETED>    ``(vi) Human data defined.--For 
                        purposes of this subparagraph, the term `human 
                        data' means data from clinical trials of safety 
                        or effectiveness, or pharmacokinetics or 
                        bioavailability studies.</DELETED>
                <DELETED>    ``(D) Information regarding safe 
                nonprescription marketing and use as a condition for 
                filing a grase request.--</DELETED>
                        <DELETED>    ``(i) In general.--In response to 
                        a request under this paragraph that a drug 
                        described in clause (ii) be generally 
                        recognized as safe and effective, the 
                        Secretary--</DELETED>
                                <DELETED>    ``(I) 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</DELETED>
                                <DELETED>    ``(II) 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).</DELETED>
                        <DELETED>    ``(ii) Drug described.--A drug 
                        described in this clause is a monograph drug 
                        that contains an active ingredient not 
                        previously incorporated in a drug--</DELETED>
                                <DELETED>    ``(I) 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;</DELETED>
                                <DELETED>    ``(II) 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</DELETED>
                                <DELETED>    ``(III) marketed in 
                                accordance with a final order issued 
                                under this section.</DELETED>
                        <DELETED>    ``(iii) Sufficient information for 
                        a threshold demonstration of nonprescription 
                        marketing and use.--Information specified in 
                        this subparagraph, with respect to a request 
                        described in clause (i)(I), is--</DELETED>
                                <DELETED>    ``(I) 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;</DELETED>
                                <DELETED>    ``(II) 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--</DELETED>
                                        <DELETED>    ``(aa) for such 
                                        period of time as needed to 
                                        provide reasonable assurances 
                                        concerning the safe 
                                        nonprescription use of the 
                                        drug; and</DELETED>
                                        <DELETED>    ``(bb) 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</DELETED>
                                <DELETED>    ``(III) 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.</DELETED>
                        <DELETED>    ``(iv) Marketing pursuant to new 
                        drug application.--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--</DELETED>
                                <DELETED>    ``(I) 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</DELETED>
                                <DELETED>    ``(II) 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.</DELETED>
                        <DELETED>    ``(v) Rule of application.--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.</DELETED>
        <DELETED>    ``(7) Treatment of final and tentative final 
        monographs.--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.</DELETED>
        <DELETED>    ``(8) Packaging.--</DELETED>
                <DELETED>    ``(A) In general.--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.</DELETED>
                <DELETED>    ``(B) Effective date.--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.</DELETED>
                <DELETED>    ``(C) Clarification.--This paragraph does 
                not authorize the Secretary to require special 
                packaging or child-resistant packaging under the Poison 
                Prevention Packaging Act of 1970.</DELETED>
<DELETED>    ``(d) Procedure for Minor Changes.--</DELETED>
        <DELETED>    ``(1) In general.--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--</DELETED>
                <DELETED>    ``(A) the requestor maintains information 
                necessary to demonstrate that the change--</DELETED>
                        <DELETED>    ``(i) will not affect the safety 
                        or effectiveness of the drug; and</DELETED>
                        <DELETED>    ``(ii) will not materially affect 
                        the extent of absorption or other exposure to 
                        the active ingredient in comparison to a 
                        suitable reference product;</DELETED>
                <DELETED>    ``(B) 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</DELETED>
                <DELETED>    ``(C) the change is in conformity with the 
                requirements of an applicable administrative order 
                issued by the Secretary under paragraph (3).</DELETED>
        <DELETED>    ``(2) Additional information.--</DELETED>
                <DELETED>    ``(A) Access to records.--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.</DELETED>
                <DELETED>    ``(B) Insufficient information.--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--</DELETED>
                        <DELETED>    ``(i) may so inform the requestor 
                        of the drug in writing; and</DELETED>
                        <DELETED>    ``(ii) provide the requestor of 
                        the drug with a reasonable opportunity to 
                        provide additional information.</DELETED>
                <DELETED>    ``(C) Failure to submit sufficient 
                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).</DELETED>
        <DELETED>    ``(3) Determining whether change will affect 
        safety or effectiveness.--</DELETED>
                <DELETED>    ``(A) In general.--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.</DELETED>
                <DELETED>    ``(B) Standard practices and special needs 
                of populations.--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.</DELETED>
<DELETED>    ``(e) Information Submitted by Requestors.--</DELETED>
        <DELETED>    ``(1) Confidential information.--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.</DELETED>
        <DELETED>    ``(2) Public availability limitations.--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--</DELETED>
                <DELETED>    ``(A) 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);</DELETED>
                <DELETED>    ``(B) 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</DELETED>
                <DELETED>    ``(C) the Secretary otherwise obtains the 
                information under subsection (d).</DELETED>
<DELETED>    ``(f) Public Availability of Administrative Orders.--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--
</DELETED>
        <DELETED>    ``(1) 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</DELETED>
        <DELETED>    ``(2) a listing of all administrative orders 
        proposed and under development on the initiative of the 
        Secretary under this section, including--</DELETED>
                <DELETED>    ``(A) a brief description of the 
                administrative order; and</DELETED>
                <DELETED>    ``(B) the expectations of the Secretary, 
                for issuance of proposed administrative orders over a 
                3-year period.</DELETED>
<DELETED>    ``(g) Updates to Drug Listing Information.--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.</DELETED>
<DELETED>    ``(h) Approvals Under Section 505.--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.</DELETED>
<DELETED>    ``(i) Development Advice to Requestors or Sponsors.--
</DELETED>
        <DELETED>    ``(1) In general.--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.</DELETED>
        <DELETED>    ``(2) Participation of multiple sponsors.--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.</DELETED>
        <DELETED>    ``(3) Private meetings with requestors.--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.</DELETED>
<DELETED>    ``(j) Effect on Existing Regulations Governing 
Nonprescription Drugs.--</DELETED>
        <DELETED>    ``(1) Regulations of general applicability to 
        nonprescription drugs.--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.</DELETED>
        <DELETED>    ``(2) Regulations establishing requirements for 
        specific nonprescription drugs.--</DELETED>
                <DELETED>    ``(A) In general.--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).</DELETED>
                <DELETED>    ``(B) Other regulations.--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.</DELETED>
                <DELETED>    ``(C) Effective date period.--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).</DELETED>
        <DELETED>    ``(3) Withdrawal of regulations.--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).</DELETED>
<DELETED>    ``(k) Guidance.--</DELETED>
        <DELETED>    ``(1) Issuance.--The Secretary shall issue 
        guidance that provides--</DELETED>
                <DELETED>    ``(A) the procedures and principles for 
                formal meetings between the Secretary and sponsors or 
                requestors for drugs subject to this section;</DELETED>
                <DELETED>    ``(B) the format and content of data 
                submissions to the Secretary under this 
                section;</DELETED>
                <DELETED>    ``(C) the format of electronic submissions 
                to the Secretary under this section;</DELETED>
                <DELETED>    ``(D) consolidated proceedings and the 
                procedures for such proceedings where appropriate; 
                and</DELETED>
                <DELETED>    ``(E) for minor changes in drugs, 
                recommendations on how to comply with the requirements 
                in administrative orders issued under subsection 
                (c)(3).</DELETED>
<DELETED>    ``(l) Electronic Format.--All submissions under this 
section shall be in an electronic format specified by the Secretary 
after providing a period for public comment.</DELETED>
<DELETED>    ``(m) Inapplicability of Paperwork Reduction Act.--Chapter 
35 of title 44, United States Code, shall not apply to collections of 
information made under this section.''.</DELETED>

<DELETED>SEC. 102. MISBRANDING.</DELETED>

<DELETED>    Section 502 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 352) is amended by inserting after subsection (dd) the 
following:</DELETED>
<DELETED>    ``(ee) If it is a nonprescription drug that is not the 
subject of an application approved under section 505, and does not 
comply with the requirements under section 505G.</DELETED>
<DELETED>    ``(ff) If it is a drug for which fees under section 744L-1 
have been assessed but have not been paid.''.</DELETED>

<DELETED>SEC. 103. CONFORMING AMENDMENTS TO THE SUNSCREEN INNOVATION 
              ACT.</DELETED>

<DELETED>    (a) Review of Nonprescription Ingredients Subject to 
Sunscreen Innovation Act.--</DELETED>
        <DELETED>    (1) Pending sunscreen ingredients.--
        Nonprescription sunscreen active ingredients or combinations of 
        sunscreen active ingredients subject, on the date of enactment 
        of this Act, to a proposed sunscreen order, as defined in 
        section 586(7) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 360fff(7)), shall--</DELETED>
                <DELETED>    (A) continue to be reviewed in accordance 
                with section 586C of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 360fff-3); or</DELETED>
                <DELETED>    (B) be reviewed under section 505G of such 
                Act upon notification of the Secretary by the sponsor 
                that such sponsor elects to have such ingredient or 
                combination of ingredients reviewed under such section 
                505G, and such proposed sunscreen order under such 
                section 586C shall be considered a proposed 
                administrative order under section 505G(c)(3)(A)(ii) of 
                such Act.</DELETED>
        <DELETED>    (2) Pending nonsunscreen ingredients.--The sponsor 
        of any application described in section 586F of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-6) that was 
        submitted to the Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary'') pursuant to 
        section 330.14 of title 21, Code of Federal Regulations (as in 
        effect on the day before the date of enactment of this Act), 
        shall--</DELETED>
                <DELETED>    (A) notify the Secretary that the sponsor 
                elects to withdraw such application; or</DELETED>
                <DELETED>    (B) notify the Secretary that the sponsor 
                elects for such ingredient to be considered under 
                section 505G of the Federal Food, Drug, and Cosmetic 
                Act, and any proposed order under such section 586F 
                shall be considered a proposed administrative order 
                under section 505G(c)(3)(A)(ii) of that Act.</DELETED>
        <DELETED>    (3) Ingredients submitted after the date of 
        enactment of section 506g.--Any ingredient that is eligible for 
        review under section 506G of the Federal Food, Drug, and 
        Cosmetic Act and is submitted after the date of enactment of 
        this Act shall be considered under that section.</DELETED>
<DELETED>    (b) Meetings Regarding Sunscreen Ingredients.--Section 
586C(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
3(b)) is amended by adding at the end the following:</DELETED>
        <DELETED>    ``(11) Meetings with sponsors.--A sponsor may 
        request an individual, confidential meeting to discuss the data 
        requirements to support a general recognition of safety and 
        effectiveness with respect to the subject of a pending 
        sunscreen ingredient. The Secretary shall respond within 14 
        calendar days of the request and schedule such meeting within 
        45 calendar days, or within such timeline as specified in the 
        letters described in section 201 of the Over-the-Counter Drug 
        Safety, Innovation, and Reform Act. If a sponsor requests more 
        than one confidential meeting for the same request, the 
        Secretary may refuse to grant an additional confidential 
        meeting request if the Secretary determines such additional 
        confidential meeting is not reasonably necessary for the 
        sponsor to advance its request. The Secretary shall publish a 
        post-meeting summary on the internet website of the Food and 
        Drug Administration of any confidential meeting that does not 
        disclose confidential business information. Such meetings shall 
        not be required to comply with guidance issued by the Secretary 
        addressing formal meetings for sponsors of human drug 
        applications, as defined in section 735.''.</DELETED>
<DELETED>    (c) Product Differentiation.--Section 586C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding 
at the end the following:</DELETED>
<DELETED>    ``(f) Product Differentiation.--</DELETED>
        <DELETED>    ``(1) In general.--A final sunscreen order 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 request and 
        listed under paragraph (5)) the exclusive right, for a period 
        of 2 years, to market a sunscreen ingredient under this section 
        incorporating changes described in paragraph (2) subject to the 
        limitations under paragraph (4), beginning on the date the 
        requestor (or any licensees, assignees, or successors in 
        interest of such requestor with respect to the subject of such 
        request and listed under paragraph (5)) may lawfully market 
        such sunscreen ingredient pursuant to the order.</DELETED>
        <DELETED>    ``(2) Changes described.--A change described in 
        this paragraph is a change subject to an order specified in 
        paragraph (1) that--</DELETED>
                <DELETED>    ``(A) permits a sunscreen to contain an 
                active ingredient not previously incorporated in a 
                marketed sunscreen listed in paragraph (3); 
                or</DELETED>
                <DELETED>    ``(B) permits a change in the conditions 
                of use of a sunscreen ingredient, 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.</DELETED>
        <DELETED>    ``(3) Marketed sunscreen.--The marketed sunscreen 
        ingredients described this paragraph are sunscreen 
        ingredients--</DELETED>
                <DELETED>    ``(A) 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;</DELETED>
                <DELETED>    ``(B) 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;</DELETED>
                <DELETED>    ``(C) 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; or</DELETED>
                <DELETED>    ``(D) marketed in accordance with a final 
                order issued under this section.</DELETED>
        <DELETED>    ``(4) Limitations on product differentiation.--
        </DELETED>
                <DELETED>    ``(A) Only one period.--Only one 2-year 
                period may be granted per ingredient under paragraph 
                (1).</DELETED>
                <DELETED>    ``(B) Exclusions.--No period of product 
                differentiation under this subparagraph shall apply to 
                changes to a sunscreen that are--</DELETED>
                        <DELETED>    ``(i) `Tier 2' changes described 
                        in section 744L(14)(A);</DELETED>
                        <DELETED>    ``(ii) safety-related changes 
                        described in section 744L-1(a)(2)(C), required 
                        under section 505G(c)(5), or any other change 
                        the Secretary determines necessary to ensure 
                        safe use; or</DELETED>
                        <DELETED>    ``(iii) changes related to methods 
                        of testing safety or efficacy.</DELETED>
        <DELETED>    ``(5) Listing of licensees, assignees, or 
        successors in interest.--Requestors shall submit to the 
        Secretary at the time when a final dosage form subject to such 
        request 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 paragraph (1).</DELETED>
        <DELETED>    ``(6) Human data defined.--For purposes of this 
        subsection, the term `human data' means data from clinical 
        trials of safety or effectiveness (including actual use 
        studies), pharmacokinetics, or bioavailability.''.</DELETED>
<DELETED>    (d) Sunscreen Innovation Act Amendments.--Section 586C(e) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(e)) is 
amended by striking paragraph (3) and inserting the 
following:</DELETED>
        <DELETED>    ``(3) Relationship to orders under section 505g.--
        A final sunscreen order shall be deemed to be a final 
        administrative order under section 505G and subject to the 
        applicable provisions under such section 505G, including with 
        respect to amendment of such order.''.</DELETED>
<DELETED>    (e) Preclusion of New Sunscreen Submissions; Option To 
Transfer Submissions to OTC Monograph Order Process.--</DELETED>
        <DELETED>    (1) Sunset.--Beginning on the date of enactment of 
        this Act, section 586A of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360fff-1) shall have no force or 
        effect.</DELETED>
        <DELETED>    (2) Option to transfer submissions to otc 
        monograph order process.--</DELETED>
                <DELETED>    (A) In general.--Any person who submitted 
                a request described in subparagraph (B) may, at any 
                time prior to the sunset of subchapter I of chapter V 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                360fff et seq.) under section 586H of such Act, 
                withdraw such request from the process under such 
                subchapter and resubmit such request as an order 
                request under section 505G of such Act.</DELETED>
                <DELETED>    (B) Requests.--A request described in this 
                subparagraph is--</DELETED>
                        <DELETED>    (i) a request under section 586A 
                        of the Federal Food, Drug, and Cosmetic Act 
                        submitted before the date of enactment of this 
                        Act; or</DELETED>
                        <DELETED>    (ii) a pending request described 
                        in section 586(6).</DELETED>
<DELETED>    (f) Treatment of Authority Regarding Finalization of 
Sunscreen Monograph.--Section 586E of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360fff-5) is amended to read as 
follows:</DELETED>

<DELETED>``SEC. 586E. SUNSCREEN ORDER.</DELETED>

<DELETED>    ``(a) In General.--</DELETED>
        <DELETED>    ``(1) Revision of final sunscreen order.--Not 
        later than November 26, 2019, the Secretary shall amend and 
        revise the final administrative order concerning 
        nonprescription sunscreen (referred to in this section as the 
        `sunscreen order') for which the substance, prior to the date 
        of enactment of the Over-the-Counter Drug Safety, Innovation, 
        and Reform Act, was represented by stayed regulations under 
        part 352 of title 21, Code of Federal Regulations.</DELETED>
        <DELETED>    ``(2) Issuance of revised sunscreen order; 
        effective date.--A revised sunscreen order described in 
        paragraph (1) shall be--</DELETED>
                <DELETED>    ``(A) effective not later than November 
                26, 2019; and</DELETED>
                <DELETED>    ``(B) issued by the Secretary at least 30 
                calendar days prior to such date.</DELETED>
<DELETED>    ``(b) Reports.--If a revised sunscreen order issued under 
subsection (a) does not include provisions related to the effectiveness 
of various sun protection factor levels, and does not address all 
dosage forms known to the Secretary to be used in sunscreens marketed 
in the United States without a new drug application approved under 
section 505, the Secretary shall submit 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 on the rationale 
for omission of such provisions from such order, and a plan and 
timeline to compile any information necessary to address such 
provisions through such order.''.</DELETED>
<DELETED>    (g) Sunset of Process Under Sunscreen Innovation Act.--
Subchapter I of chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff et seq.), as amended by subsection (f), is further 
amended by inserting at the end the following new section:</DELETED>

<DELETED>``SEC. 586H. SUNSET.</DELETED>

<DELETED>    ``This subchapter shall no longer be effective upon the 
later of--</DELETED>
        <DELETED>    ``(1) a final determination by the Secretary under 
        this subchapter with respect to every request described in 
        section 586A(b)(2) (other than any withdrawn requests and 
        requests resubmitted as order requests under section 505G); 
        or</DELETED>
        <DELETED>    ``(2) the effective date of the revised sunscreen 
        order described in section 586E(a)(2).''.</DELETED>

<DELETED>SEC. 104. DRUGS EXCLUDED FROM OVER-THE-COUNTER 
              REVIEW.</DELETED>

<DELETED>    (a) In General.--Nothing in this Act (or the amendments 
made by this Act) shall apply to any nonprescription drug which was 
excluded by the Food and Drug Administration from the Over-the-Counter 
Drug Review in accordance with the statement set out at page 9466 of 
volume 37 of the Federal Register, published on May 11, 1972.</DELETED>
<DELETED>    (b) Rule of Construction.--Nothing in this section shall 
be construed to preclude or limit the applicability of any provision of 
the Federal Food, Drug, and Cosmetic Act.</DELETED>

<DELETED>SEC. 105. CONFORMING AMENDMENT.</DELETED>

<DELETED>    Section 751(d)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379r(d)(1)) is amended--</DELETED>
        <DELETED>    (1) in the matter preceding subparagraph (A)--
        </DELETED>
                <DELETED>    (A) by striking ``final regulation'' and 
                inserting ``final order''; and</DELETED>
                <DELETED>    (B) by striking ``and not misbranded''; 
                and</DELETED>
        <DELETED>    (2) in subparagraph (A), by striking ``regulation 
        in effect'' and inserting ``regulation or order in 
        effect''.</DELETED>

<DELETED>SEC. 106. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC 
              INDICATION FOR CERTAIN COUGH AND COLD MONOGRAPH 
              DRUGS.</DELETED>

<DELETED>    (a) In General.--Not later than one year after the date of 
enactment of this Act and annually thereafter, the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary'') 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a letter describing the progress of the Food and Drug 
Administration--</DELETED>
        <DELETED>    (1) in evaluating the cough and cold monograph 
        described in subsection (b) with respect to children under age 
        6; and</DELETED>
        <DELETED>    (2) as appropriate, revising such cough and cold 
        monograph to address such children, through the administrative 
        order process under section 505G(b) of the Federal Food, Drug, 
        and Cosmetic Act, as added by section 101.</DELETED>
<DELETED>    (b) Cough and Cold Monograph Described.--The cough and 
cold monograph described in this subsection consists of the conditions 
under which nonprescription drug products containing antitussive, 
expectorant, nasal decongestant, or antihistamine active ingredients 
(or combinations thereof) are generally recognized as safe and 
effective, as specified in part 341 of title 21, Code of Federal 
Regulations (as in effect on the day before the date of enactment of 
this Act), and included in an administrative order deemed established 
under such section 505G(b) of the Federal Food, Drug, and Cosmetic 
Act.</DELETED>
<DELETED>    (c) Duration of Authority.--Subsection (a) shall have no 
force or effect beginning on the date on which the Secretary submits a 
letter under subsection (a) in which the Secretary indicates that the 
Food and Drug Administration has completed its evaluation and revised, 
in a final administrative order, as applicable, the cough and cold 
monograph in accordance with this section.</DELETED>

     <DELETED>TITLE II--FEES RELATING TO MONOGRAPH DRUGS</DELETED>

<DELETED>SEC. 201. SHORT TITLE; FINDINGS.</DELETED>

<DELETED>    (a) Short Title.--This title may be cited as the ``Over-
the-Counter Monograph User Fee Act of 2018''.</DELETED>
<DELETED>    (b) Findings.--The Congress finds that the fees authorized 
by the amendments made in this title will be dedicated toward the 
regulation of monograph drugs under section 505G of the Federal, Food, 
Drug, and Cosmetic Act, as set forth in the goals identified for 
purposes of such section, in the letters from the Secretary of Health 
and Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman of the 
Committee on Energy and Commerce of the House of Representatives, as 
set forth in the Congressional Record.</DELETED>

<DELETED>SEC. 202. AUTHORITY TO ACCESS AND USE FEES.</DELETED>

<DELETED>    Subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at the end 
the following:</DELETED>

     <DELETED>``PART 10--FEES RELATING TO MONOGRAPH DRUGS</DELETED>

<DELETED>``SEC. 744L. DEFINITIONS.</DELETED>

<DELETED>    ``For purposes of this part:</DELETED>
        <DELETED>    ``(1) The term `affiliate' means a business entity 
        that has a relationship with a second business entity if, 
        directly or indirectly--</DELETED>
                <DELETED>    ``(A) one business entity controls, or has 
                the power to control, the other business entity; 
                or</DELETED>
                <DELETED>    ``(B) a third party controls, or has power 
                to control, both of the business entities.</DELETED>
        <DELETED>    ``(2) the term `contract manufacturing 
        organization facility' means a monograph drug facility where 
        neither the owner of such manufacturing facility nor any 
        affiliate of such owner or facility sells such monograph drug 
        produced at such facility directly to wholesalers, retailers, 
        or consumers in the United States.</DELETED>
        <DELETED>    ``(3) The term `costs of resources allocated for 
        monograph drug activities' means the expenses in connection 
        with monograph drug activities for--</DELETED>
                <DELETED>    ``(A) officers and employees of the Food 
                and Drug Administration, contractors of the Food and 
                Drug Administration, advisory committees, and costs 
                related to such officers, employees, and committees and 
                to contracts with such contractors;</DELETED>
                <DELETED>    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;</DELETED>
                <DELETED>    ``(C) leasing, maintenance, renovation, 
                and repair of facilities and acquisition, maintenance, 
                and repair of fixtures, furniture, scientific 
                equipment, and other necessary materials and supplies; 
                and</DELETED>
                <DELETED>    ``(D) collecting fees under section 744L-1 
                and accounting for resources allocated for monograph 
                drug activities.</DELETED>
        <DELETED>    ``(4) The term `firm establishment identifier' is 
        the unique number automatically generated by the Field 
        Accomplishments and Compliance Tracking System of the Food and 
        Drug Administration.</DELETED>
        <DELETED>    ``(5) The term `monograph drug' shall have the 
        meaning given the term under section 505G.</DELETED>
        <DELETED>    ``(6) The term `monograph drug activities' means 
        activities of the Secretary associated with monograph drug 
        products and inspection of facilities associated with such 
        products, including--</DELETED>
                <DELETED>    ``(A) the activities necessary for review 
                and evaluation of monograph drugs and monograph drug 
                order requests, including--</DELETED>
                        <DELETED>    ``(i) orders proposing or 
                        finalizing applicable requirements of use for 
                        monograph drugs products;</DELETED>
                        <DELETED>    ``(ii) orders affecting status 
                        regarding general recognition of safety and 
                        effectiveness of a monograph drug ingredient or 
                        combination of ingredients under specified 
                        requirements of use;</DELETED>
                        <DELETED>    ``(iii) all monograph drug 
                        development and review activities, including 
                        intra-agency collaboration;</DELETED>
                        <DELETED>    ``(iv) regulation and policy 
                        development activities related to monograph 
                        drugs;</DELETED>
                        <DELETED>    ``(v) development of product 
                        standards for products subject to review and 
                        evaluation;</DELETED>
                        <DELETED>    ``(vi) meetings regarding 
                        monograph drug activities;</DELETED>
                        <DELETED>    ``(vii) review of labeling prior 
                        to issuance of orders related to monograph 
                        drugs or conditions of use; and</DELETED>
                        <DELETED>    ``(viii) regulatory science 
                        activities related to monograph 
                        drugs;</DELETED>
                <DELETED>    ``(B) inspections related to monograph 
                drugs;</DELETED>
                <DELETED>    ``(C) monitoring of clinical and other 
                research conducted in connection with monograph 
                drugs;</DELETED>
                <DELETED>    ``(D) safety activities with respect to 
                monograph drugs, including--</DELETED>
                        <DELETED>    ``(i) collecting, developing, and 
                        reviewing safety information on monograph 
                        drugs, including adverse event 
                        reports;</DELETED>
                        <DELETED>    ``(ii) developing and using 
                        improved adverse event data-collection systems, 
                        including information technology systems; 
                        and</DELETED>
                        <DELETED>    ``(iii) developing and using 
                        improved analytical tools to assess potential 
                        safety risks, including access to external 
                        databases; and</DELETED>
                <DELETED>    ``(E) other activities necessary for 
                implementation of section 505G.</DELETED>
        <DELETED>    ``(7)(A) The term `monograph drug facility' means 
        a foreign or domestic business or other entity--</DELETED>
                <DELETED>    ``(i) that is under one management, either 
                direct or indirect;</DELETED>
                <DELETED>    ``(ii) at one geographic location or 
                address engaged in manufacturing or processing a 
                monograph drug in finished dosage form;</DELETED>
                <DELETED>    ``(iii) includes a finished dosage form 
                manufacturer facility or an affiliate thereof in a 
                contractual relationship with a monograph drug 
                requestor or requestors to manufacture or process 
                monograph drugs; and</DELETED>
                <DELETED>    ``(iv) does not include a business or 
                other entity whose only manufacturing or processing 
                activities relate to--</DELETED>
                        <DELETED>    ``(I) production of clinical 
                        research supplies;</DELETED>
                        <DELETED>    ``(II) testing; or</DELETED>
                        <DELETED>    ``(III) packaging of packaged 
                        final dosages in a manner that does not affect 
                        the drug.</DELETED>
        <DELETED>    ``(B) For purposes of subparagraph (A), separate 
        buildings or locations within close proximity are considered to 
        be at 1 geographic location or address if the activities 
        conducted in them are--</DELETED>
                <DELETED>    ``(i) closely related to the same business 
                enterprise;</DELETED>
                <DELETED>    ``(ii) under the supervision of the same 
                local management; and</DELETED>
                <DELETED>    ``(iii) under a single firm establishment 
                identifier and capable of being inspected by the Food 
                and Drug Administration during a single 
                inspection.</DELETED>
        <DELETED>    ``(C) If a business or other entity would meet the 
        definition of a facility under this paragraph but for being 
        under multiple management, the business or other entity is 
        deemed to constitute multiple facilities, one per management 
        entity, for purposes of this paragraph.</DELETED>
        <DELETED>    ``(8) The term `monograph drug meeting' means any 
        meeting regarding the content of a proposed monograph drug 
        order request.</DELETED>
        <DELETED>    ``(9) The term `monograph drug product' means a 
        monograph drug product that is marketed without an approved new 
        drug application in accordance with section 505G.</DELETED>
        <DELETED>    ``(10) The term `monograph drug order request' 
        means a request for an order under section 505G for the 
        issuance of an administrative order for a change to the 
        monograph drug product.</DELETED>
        <DELETED>    ``(11) The term `monograph drug requestor' means 
        an entity submitting a monograph drug order request or a 
        monograph drug meeting request or any other inquiry relating to 
        a request for an order or development of a monograph drug order 
        request.</DELETED>
        <DELETED>    ``(12) The term `person' includes an affiliate 
        thereof.</DELETED>
        <DELETED>    ``(13) The term `Tier 1 monograph drug order 
        request' means any monograph drug order request not determined 
        to be a Tier 2 monograph drug order request.</DELETED>
        <DELETED>    ``(14)(A) The term `Tier 2 monograph drug order 
        request' means subject to subparagraph (B), a monograph drug 
        order request for--</DELETED>
                <DELETED>    ``(i) the reordering of existing 
                information in the drug facts label of a monograph drug 
                product;</DELETED>
                <DELETED>    ``(ii) the addition of information to the 
                other information section of the drug facts label of a 
                nonprescription drug product, as limited by part 
                201.66(c)(7) of title 21, Code of Federal 
                Regulations;</DELETED>
                <DELETED>    ``(iii) modification to the directions for 
                use section of the drug facts label of a 
                nonprescription drug product, if such changes conform 
                to changes made pursuant to section 505G(d);</DELETED>
                <DELETED>    ``(iv) the standardization of the 
                concentration or dose of a specific finalized 
                ingredient within a particular finalized 
                monograph;</DELETED>
                <DELETED>    ``(v) a change to ingredient nomenclature 
                to align with nomenclature of a standards-setting 
                organization; or</DELETED>
                <DELETED>    ``(vi) addition of an interchangeable term 
                in accordance with part 330.1 of title 21, Code of 
                Federal Regulations.</DELETED>
        <DELETED>    ``(B) The Secretary may, based on program 
        implementation experience or other factors found appropriate by 
        the Secretary, characterize any monograph drug order request as 
        a Tier 2 monograph drug order request (including recategorizing 
        a request from Tier 1 to Tier 2) and publish such determination 
        in a proposed order issued pursuant to section 
        505G(c).</DELETED>

<DELETED>``SEC. 744L-1. AUTHORITY TO ASSESS AND USE MONOGRAPH DRUG 
              FEES.</DELETED>

<DELETED>    ``(a) Types of Fees.--Beginning with fiscal year 2018, the 
Secretary shall assess and collect fees in accordance with this section 
as follows:</DELETED>
        <DELETED>    ``(1) Facility fee.--</DELETED>
                <DELETED>    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that owns a facility 
                identified as a monograph drug facility on December 31 
                of the fiscal year or at any time during the preceding 
                12-month period shall be assessed an annual fee for 
                each such facility as determined under subsection 
                (c).</DELETED>
                <DELETED>    ``(B) Exception.--</DELETED>
                        <DELETED>    ``(i) In general.--A fee shall not 
                        be assessed under subparagraph (A) if the 
                        identified monograph drug facility has ceased 
                        all activities related to monograph drug 
                        products prior to the publication of the Notice 
                        under subparagraph C and has updated its 
                        registration to reflect such change under the 
                        requirements for drug establishment 
                        registration set forth in section 
                        510.</DELETED>
                        <DELETED>    ``(ii) Fee amount.--The amount of 
                        the fee for a contract manufacturing 
                        organization facility shall be equal to two-
                        thirds the amount of the fee for a monograph 
                        drug facility that is not a contract 
                        manufacturing organization facility.</DELETED>
                <DELETED>    ``(C) Due date.--For each fiscal year, the 
                facility fees required under subparagraph (A) shall be 
                due on the later of--</DELETED>
                        <DELETED>    ``(i) the first business day of 
                        April of such year; and</DELETED>
                        <DELETED>    ``(ii) the first business day 
                        after the date of enactment of an 
                        appropriations Act providing for the collection 
                        and obligation of fees under this section for 
                        such year.</DELETED>
        <DELETED>    ``(2) Monograph drug order request fee.--
        </DELETED>
                <DELETED>    ``(A) In general.--Each person that 
                submits a monograph drug order request shall be subject 
                to a fee for a monograph drug order request. The 
                monograph drug order request fee under paragraph (2) 
                shall be--</DELETED>
                        <DELETED>    ``(i) for a Tier 1 monograph drug 
                        order request, $500,000, adjusted for inflation 
                        for the fiscal year (as determined under 
                        subsection (c)(1)); and</DELETED>
                        <DELETED>    ``(ii) for a Tier 2 monograph drug 
                        order request other than a Tier 1 request, 
                        $100,000 adjusted for inflation for the fiscal 
                        year (as determined under subsection 
                        (c)(1)).</DELETED>
                <DELETED>    ``(B) Due date.--The monograph drug order 
                request fees required under subparagraph (A) shall be 
                due on the date of submission of the monograph drug 
                order request.</DELETED>
                <DELETED>    ``(C) Exception for certain safety 
                changes.--A person who is named as the requestor in a 
                monograph drug order shall not be subject to a fee 
                under subparagraph (A) if the Secretary finds that the 
                monograph drug order request seeks to change the Drug 
                Facts labeling of a monograph drug product in a way 
                that would add to or strengthen--</DELETED>
                        <DELETED>    ``(i) a contraindication, warning, 
                        or precaution;</DELETED>
                        <DELETED>    ``(ii) a statement about risk 
                        associated with misuse or abuse; or</DELETED>
                        <DELETED>    ``(iii) an instruction about 
                        dosage and administration that is intended to 
                        increase the safe use of the monograph drug 
                        product.</DELETED>
                <DELETED>    ``(D) Refund of fee if order request is 
                recategorized as a tier 2 monograph drug order 
                request.--If the Secretary determines that a monograph 
                drug request initially characterized as Tier 1 should 
                be re-characterized as a Tier 2 monograph drug order 
                request, and the requestor has paid a Tier 1 fee in 
                accordance with subparagraph (A)(i), the Secretary 
                shall refund the requestor the difference between the 
                Tier 1 and Tier 2 fees determined under subparagraphs 
                (A)(i) and (A)(ii), respectively.</DELETED>
                <DELETED>    ``(E) Refund of fee if order request 
                refused for filing or withdrawn before filing.--The 
                Secretary shall refund 75 percent of the fee paid under 
                subparagraph (B) for any order request that is refused 
                for filing.</DELETED>
                <DELETED>    ``(F) Fees for order requests previously 
                refused for filing or withdrawn before filing.--A 
                monograph drug order request that was submitted but was 
                refused for filing, or was withdrawn before being 
                accepted or refused for filing, shall be subject to the 
                full fee under subparagraph (A) upon being resubmitted 
                or filed over protest.</DELETED>
                <DELETED>    ``(G) Refund of fee if order request 
                withdrawn.--If an order request is withdrawn after the 
                order request was filed, the Secretary may refund the 
                fee or a portion of the fee if no substantial work was 
                performed on the order request after the application 
                was filed. The Secretary shall have the sole discretion 
                to refund a fee or a portion of the fee under this 
                subparagraph. A determination by the Secretary 
                concerning a refund under this paragraph shall not be 
                reviewable.</DELETED>
        <DELETED>    ``(3) Refunds.--</DELETED>
                <DELETED>    ``(A) In general.--Other than refunds 
                under subparagraphs (D) through (G) of paragraph (2), 
                the Secretary shall not refund any fee paid under this 
                subsection, except as provided in subparagraph 
                (B).</DELETED>
                <DELETED>    ``(B) Disputes concerning fees.--To 
                qualify for the return of a fee claimed to have been 
                paid in error under this paragraph, a person shall 
                submit to the Secretary a written request justifying 
                such return within 180 calendar days after such fee was 
                paid.</DELETED>
<DELETED>    ``(b) Fee Revenue Amounts.--</DELETED>
        <DELETED>    ``(1) Fiscal year 2018.--For fiscal year 2018, 
        fees under subsection (a)(1) shall be established to generate a 
        total facility fee revenue amount equal to the sum of--
        </DELETED>
                <DELETED>    ``(A) the annual base revenue for fiscal 
                year 2018 (as determined under paragraph 
                (3));</DELETED>
                <DELETED>    ``(B) the dollar amount equal to the 
                operating reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection (c)(2)); 
                and</DELETED>
                <DELETED>    ``(C) additional direct cost adjustments 
                (as determined under subsection (c)(3)).</DELETED>
        <DELETED>    ``(2) Subsequent fiscal years.--For each of the 
        fiscal years 2019 through 2022, fees under subsection (a)(1) 
        shall be established to generate a total facility fee revenue 
        amount equal to the sum of--</DELETED>
                <DELETED>    ``(A) the annual base revenue for the 
                fiscal year (as determined under paragraph 
                (3));</DELETED>
                <DELETED>    ``(B) the dollar amount equal to the 
                inflation adjustment for the fiscal year (as determined 
                under subsection (c)(1));</DELETED>
                <DELETED>    ``(C) the dollar amount equal to the 
                operating reserve adjustment for the fiscal year, if 
                applicable (as determined under subsection 
                (c)(2));</DELETED>
                <DELETED>    ``(D) additional direct cost adjustments 
                (as determined under subsection (c)(3)); and</DELETED>
                <DELETED>    ``(E) additional dollar amounts for each 
                fiscal year as follows:</DELETED>
                        <DELETED>    ``(i) $7,000,000 for fiscal year 
                        2019.</DELETED>
                        <DELETED>    ``(ii) $6,000,000 for fiscal year 
                        2020.</DELETED>
                        <DELETED>    ``(iii) $7,000,000 for fiscal year 
                        2021.</DELETED>
                        <DELETED>    ``(iv) $3,000,000 for fiscal year 
                        2022.</DELETED>
        <DELETED>    ``(3) Annual base revenue.--For purposes of 
        paragraphs (1)(A) and (2)(A), the dollar amount of the annual 
        base revenue for a fiscal year shall be--</DELETED>
                <DELETED>    ``(A) for fiscal year 2018, $8,000,000; 
                and</DELETED>
                <DELETED>    ``(B) for fiscal years 2019 through 2022, 
                the dollar amount of the total revenue amount 
                established under this subsection for the previous 
                fiscal year, not including any adjustments made under 
                subsection (c)(2) or (c)(3).</DELETED>
<DELETED>    ``(c) Adjustments; Annual Fee Setting.--</DELETED>
        <DELETED>    ``(1) Inflation adjustment.--</DELETED>
                <DELETED>    ``(A) In general.--For purposes of 
                subsection (b)(2)(B), the dollar amount of the 
                inflation adjustment to the annual base revenue for 
                fiscal year 2019 and each subsequent fiscal year shall 
                be equal to the product of--</DELETED>
                        <DELETED>    ``(i) such annual base revenue for 
                        the fiscal year under subsection (b)(2); 
                        and</DELETED>
                        <DELETED>    ``(ii) the inflation adjustment 
                        percentage under subparagraph (B).</DELETED>
                <DELETED>    ``(B) Inflation adjustment percentage.--
                The inflation adjustment percentage under this 
                subparagraph for a fiscal year is equal to--</DELETED>
                        <DELETED>    ``(i) for each of fiscal years 
                        2019 through 2020, the average annual percent 
                        change that occurred in the Consumer Price 
                        Index for urban consumers (Washington-
                        Baltimore, DC-MD-VA-WV; Not Seasonally 
                        Adjusted; All items; Annual Index) for the 
                        first 3 years of the preceding 4 years of 
                        available data; and</DELETED>
                        <DELETED>    ``(ii) for each of fiscal years 
                        2021 and 2022, the sum of--</DELETED>
                                <DELETED>    ``(I) the average annual 
                                percent change in the cost, per full-
                                time equivalent position of the Food 
                                and Drug Administration, of all 
                                personnel compensation and benefits 
                                paid with respect to such positions for 
                                the first 3 years of the preceding 4 
                                fiscal years, multiplied by the 
                                proportion of personnel compensation 
                                and benefits costs to total costs of 
                                monograph drug activities (as defined 
                                in subsection (a)) for the first 3 
                                years of the preceding 4 fiscal years; 
                                and</DELETED>
                                <DELETED>    ``(II) the average annual 
                                percent change that occurred in the 
                                Consumer Price Index for urban 
                                consumers (Washington-Baltimore, DC-MD-
                                VA-WV; Not Seasonally Adjusted; All 
                                items; Annual Index) for the first 3 
                                years of the preceding 4 years of 
                                available data multiplied by the 
                                proportion of all costs other than 
                                personnel compensation and benefits 
                                costs to total costs of monograph drug 
                                activities for the first 3 years of the 
                                preceding 4 fiscal years.</DELETED>
        <DELETED>    ``(2) Operating reserve adjustment.--</DELETED>
                <DELETED>    ``(A) For fiscal year 2018 and subsequent 
                fiscal years, the Secretary may, in addition to 
                adjustments under paragraphs (1) and (2), further 
                increase the fee revenue and fees if such an adjustment 
                is necessary to provide operating reserves of carryover 
                user fees for monograph drug activities for the number 
                of weeks specified in subparagraph (B).</DELETED>
                <DELETED>    ``(B) For each fiscal year the number of 
                weeks of operating reserves shall be no more than--
                </DELETED>
                        <DELETED>    ``(i) 3 weeks for fiscal year 
                        2018;</DELETED>
                        <DELETED>    ``(ii) 7 weeks for fiscal year 
                        2019;</DELETED>
                        <DELETED>    ``(iii) 10 weeks for fiscal year 
                        2020;</DELETED>
                        <DELETED>    ``(iv) 10 weeks for fiscal year 
                        2021; and</DELETED>
                        <DELETED>    ``(v) 10 weeks for fiscal year 
                        2022.</DELETED>
                <DELETED>    ``(C) If, for fiscal years 2019 through 
                2022, the Secretary has carryover balances for 
                monograph drug activities in excess of the number of 
                weeks of such operating reserves specified in 
                subparagraph B, the Secretary shall reduce such fee 
                revenue and fees to provide for not more than the 
                number of weeks of such operating reserves specified in 
                subparagraph (B)(v).</DELETED>
                <DELETED>    ``(D) If an adjustment under this 
                paragraph is made, the rationale for the amount of the 
                increase or decrease (as applicable) in fee revenue and 
                fees shall be contained in the annual Federal Register 
                notice under paragraph (5) establishing fee revenue and 
                fees for the fiscal year involved.</DELETED>
        <DELETED>    ``(3) Additional direct cost adjustment.--The 
        Secretary shall, in addition to adjustments under paragraphs 
        (1) and (2), further increase the fee revenue by an amount 
        equal to--</DELETED>
                <DELETED>    ``(A) 14,000,000 for fiscal year 
                2018;</DELETED>
                <DELETED>    ``(B) 7,000,000 for fiscal year 
                2019;</DELETED>
                <DELETED>    ``(C) 4,000,000 for fiscal year 
                2020;</DELETED>
                <DELETED>    ``(D) 3,000,000 for fiscal year 2021; 
                and</DELETED>
                <DELETED>    ``(E) 3,000,000 for fiscal year 
                2022.</DELETED>
        <DELETED>    ``(4) Annual fee setting.--</DELETED>
                <DELETED>    ``(A) Fiscal year 2018.--The Secretary 
                shall, not later than January 31, 2018--</DELETED>
                        <DELETED>    ``(i) establish monograph drug 
                        facility fees for fiscal year 2018 under 
                        subsection (a)(1), based on the revenue amount 
                        for such year under subsection (b) and the 
                        adjustments provided under this subsection; 
                        and</DELETED>
                        <DELETED>    ``(ii) publish such fee revenue 
                        and facility fees in the Federal 
                        Register.</DELETED>
                <DELETED>    ``(B) Subsequent fiscal years.--The 
                Secretary shall, not later than January 31 of each 
                fiscal year that begins after September 30, 2018, 
                establish for each such fiscal year, based on the 
                revenue amounts under subsection (b) and the 
                adjustments provided under this subsection--</DELETED>
                        <DELETED>    ``(i) monograph drug facility fees 
                        under subsection (a)(1);</DELETED>
                        <DELETED>    ``(ii) monograph drug order 
                        request fees under subsection (a)(2); 
                        and</DELETED>
                        <DELETED>    ``(iii) publish such fee revenue, 
                        facility fees, and monograph drug order request 
                        fees in the Federal Register.</DELETED>
<DELETED>    ``(d) Identification of Facilities.--Each person that owns 
a monograph drug facility shall submit to the Secretary the information 
required under this subsection each year. Such information shall, for 
each fiscal year--</DELETED>
        <DELETED>    ``(1) be submitted as part of the requirements for 
        drug establishment registration set forth in section 510; 
        and</DELETED>
        <DELETED>    ``(2) include for each such facility, at a 
        minimum, identification of the facility's business operation as 
        that of a monograph drug facility.</DELETED>
<DELETED>    ``(e) Effect of Failure To Pay Fees.--</DELETED>
        <DELETED>    ``(1) In general.--A monograph drug order request 
        submitted by a person subject to fees under subsection (a) 
        shall be considered incomplete and shall not be accepted for 
        filing by the Secretary until all fees owed by such person have 
        been paid.</DELETED>
        <DELETED>    ``(2) Effect on eligibility for meetings.--If a 
        monograph drug requestor fails to pay a fee assessed under 
        subsection (a), the requestor shall be considered ineligible 
        for monograph drug meetings.</DELETED>
<DELETED>    ``(f) Monograph Drug Facility Fee.--Failure to pay the fee 
under subsection (a)(1) within 20 calendar days of the due date as 
specified in subparagraph (D) of such subsection shall result in the 
Secretary placing the facility on a publicly available arrears list 
until such fee has been paid.</DELETED>
<DELETED>    ``(g) Crediting and Availability of Fees.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2)(D), 
        fees authorized under subsection (a) shall be collected and 
        available for obligation only to the extent and in the amount 
        provided in advance in appropriations Acts. Such fees are 
        authorized to remain available until expended. Such sums as may 
        be necessary may be transferred from the Food and Drug 
        Administration salaries and expenses appropriation account 
        without fiscal year limitation to such appropriation account 
        for salaries and expenses with such fiscal year limitation. The 
        sums transferred shall be available solely for monograph drug 
        activities.</DELETED>
        <DELETED>    ``(2) Collections and appropriation acts.--
        </DELETED>
                <DELETED>    ``(A) In general.--Subject to 
                subparagraphs (C) and (D), the fees authorized by this 
                section shall be collected and available in each fiscal 
                year in an amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation, for such fiscal year.</DELETED>
                <DELETED>    ``(B) Use of fees and limitation.--The 
                fees authorized by this section shall be available to 
                defray increases in the costs of the resources 
                allocated for monograph drug activities (including 
                increases in such costs for an additional number of 
                full-time equivalent positions in the Department of 
                Health and Human Services to be engaged in such 
                activities), only if the Secretary allocates for such 
                purpose an amount for such fiscal year (excluding 
                amounts from fees collecting under this section) no 
                less than $12,000,000, multiplied by the adjustment 
                factor applicable to the fiscal year 
                involved.</DELETED>
                <DELETED>    ``(C) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (B) in any fiscal year if the costs funded by 
                appropriations and allocated for the monograph drug 
                activities are not more than 15 percent below the level 
                specified in such subparagraph.</DELETED>
                <DELETED>    ``(D) Fee collection during first program 
                year.--Until the date of enactment of an Act making 
                appropriations and providing for the collection and 
                obligation of fees under this section through September 
                30, 2018, for the salaries and expenses account of the 
                Food and Drug Administration, fees authorized by this 
                section for fiscal year 2018 may be collected and shall 
                be credited to such account and remain available until 
                expended.</DELETED>
                <DELETED>    ``(E) Provision for early payments in 
                subsequent years.--Payment of fees authorized under 
                this section for a fiscal year (after fiscal year 
                2018), prior to the due date for such fees, may be 
                accepted by the Secretary in accordance with authority 
                provided in advance in a prior year appropriations 
                Act.</DELETED>
        <DELETED>    ``(3) Authorization of appropriations.--For each 
        of the fiscal years 2018 through 2022, there is authorized to 
        be appropriated for fees under this section an amount equal to 
        the total amount of fees assessed for such fiscal year under 
        this section.</DELETED>
<DELETED>    ``(h) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under subsection 
(a) within 30 calendar days after it is due, such fee shall be treated 
as a claim of the United States Government subject to subchapter II of 
chapter 37 of title 31.</DELETED>
<DELETED>    ``(i) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in the 
Department of Health and Human Services, for officers, employers, and 
advisory committees not engaged in monograph drug activities, be 
reduced to offset the number of officers, employees, and advisory 
committees so engaged.</DELETED>

<DELETED>``SEC. 744L-2. REAUTHORIZATION; REPORTING 
              REQUIREMENTS.</DELETED>

<DELETED>    ``(a) Performance Report.--Beginning with fiscal year 
2018, and not later than 120 calendar days after the end of each fiscal 
year thereafter for which fees are collected under this part, the 
Secretary shall prepare and submit to the Committee on the Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report concerning 
the progress of the Food and Drug Administration in achieving the goals 
identified in the letters described in section 201 of the during such 
fiscal year and the future plans of the Food and Drug Administration 
for meeting such goals.</DELETED>
<DELETED>    ``(b) Fiscal Report.--Not later than 120 calendar days 
after the end of fiscal year 2018 and each subsequent fiscal year for 
which fees are collected under this part, the Secretary shall prepare 
and submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the implementation of the authority for 
such fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.</DELETED>
<DELETED>    ``(c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the public 
on the internet website of the Food and Drug Administration.</DELETED>
<DELETED>    ``(d) Reauthorization.--</DELETED>
        <DELETED>    ``(1) Consultation.--In developing recommendations 
        to present to Congress with respect to the goals described in 
        subsection (a), and plans for meeting the goals, for monograph 
        drug activities for the first 5 fiscal years after fiscal year 
        2022, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--</DELETED>
                <DELETED>    ``(A) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;</DELETED>
                <DELETED>    ``(B) the Committee on Energy and Commerce 
                of the House of Representatives;</DELETED>
                <DELETED>    ``(C) scientific and academic 
                experts;</DELETED>
                <DELETED>    ``(D) health care professionals;</DELETED>
                <DELETED>    ``(E) representatives of patient and 
                consumer advocacy groups; and</DELETED>
                <DELETED>    ``(F) the regulated industry.</DELETED>
        <DELETED>    ``(2) Public review of recommendations.--After 
        negotiations with the regulated industry, the Secretary shall--
        </DELETED>
                <DELETED>    ``(A) present the recommendations 
                developed under paragraph (1) to the congressional 
                committees specified in such paragraph;</DELETED>
                <DELETED>    ``(B) publish such recommendations in the 
                Federal Register;</DELETED>
                <DELETED>    ``(C) provide for a period of 30 calendar 
                days for the public to provide written comments on such 
                recommendations;</DELETED>
                <DELETED>    ``(D) hold a meeting at which the public 
                may present its views on such recommendations; 
                and</DELETED>
                <DELETED>    ``(E) after consideration of such public 
                views and comments, revise such recommendations as 
                necessary.</DELETED>
        <DELETED>    ``(3) Transmittal of recommendations.--Not later 
        than January 15, 2022, the Secretary shall transmit to Congress 
        the revised recommendations under paragraph (2), a summary of 
        the views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.''.</DELETED>

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Over-the-Counter 
Drug Safety, Innovation, and Reform Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.

              TITLE I--REGULATION OF NONPRESCRIPTION DRUGS

Sec. 101. Regulation of certain nonprescription drugs that are marketed 
                            without an approved new drug application.
Sec. 102. Misbranding.
Sec. 103. Conforming amendments to the Sunscreen Innovation Act.
Sec. 104. Drugs excluded from over-the-counter review.
Sec. 105. Conforming amendment.
Sec. 106. Annual update to Congress on appropriate pediatric indication 
                            for certain cough and cold monograph drugs.

               TITLE II--FEES RELATING TO MONOGRAPH DRUGS

Sec. 201. Short title; findings.
Sec. 202. Authority to assess and use fees.

              TITLE I--REGULATION OF NONPRESCRIPTION DRUGS

SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED 
              WITHOUT AN APPROVED NEW DRUG APPLICATION.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 505F (21 U.S.C. 355g) the following:

``SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE 
              MARKETED WITHOUT AN APPROVED NEW DRUG APPLICATION.

    ``(a) Definitions.--In this section:
            ``(1) Nonprescription drug.--The term `nonprescription 
        drug' means a drug that is not subject to section 503(b)(1).
            ``(2) Requestor.--The term `requestor' means a person or 
        group of persons marketing, manufacturing, processing, or 
        developing a drug.
            ``(3) Sponsor.--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.
    ``(b) Treatment of Monograph Drugs Marketed Without an Approved 
Application.--
            ``(1) In general.--A nonprescription drug that is marketed 
        without an approved application under section 505 shall be 
        treated in accordance with this subsection beginning on the 
        date of enactment of the Over-the-Counter Drug Safety, 
        Innovation, and Reform Act:
                    ``(A) 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--
                            ``(i)(I)(aa) 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;
                            ``(bb) in conformity with the requirements 
                        for nonprescription use of such monograph, the 
                        general requirements specified for 
                        nonprescription drugs, and the requirements 
                        under subsections (c), (d), and (j); and
                            ``(cc) 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, 
                        on day before the date of enactment of the 
                        Over-the-Counter Drug Safety, Innovation, and 
                        Reform Act, has been used to a material extent 
                        and for a material time within the meaning of 
                        section 201(p)(2);
                            ``(II)(aa) 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, on 
                        the day before the date of enactment of the 
                        Over-the-Counter Drug Safety, Innovation, and 
                        Reform Act;
                            ``(bb) classified in category I for safety 
                        and effectiveness under such tentative final 
                        monograph;
                            ``(cc) in conformity with the requirements 
                        for nonprescription use of such tentative final 
                        monograph, any subsequent determination by the 
                        Secretary, the general requirements for 
                        nonprescription drugs, and the requirements 
                        under subsections (c), (d), and (j); and
                            ``(dd) 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
                            ``(III) in conformity with--
                                    ``(aa) the requirements of a final 
                                administrative order issued under 
                                subsection (c) determining that such 
                                drug is generally recognized as safe 
                                and effective within the meaning of 
                                section 201(p)(1); and
                                    ``(bb) the general requirements for 
                                nonprescription drugs and the 
                                requirements under subsections (c), 
                                (d), and (j);
                            ``(ii) not classified in Category II for 
                        safety or effectiveness under a tentative final 
                        monograph; and
                            ``(iii) not determined by the Secretary to 
                        be not generally recognized as 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.
                    ``(B) A nonprescription drug for which there is not 
                an approved application under section 505 may be 
                introduced into interstate commerce if such drug is--
                            ``(i)(I) not classified in Category II for 
                        safety or effectiveness under a tentative final 
                        monograph; or
                            ``(II) not determined by the Secretary to 
                        be not generally recognized as 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
                            ``(ii)(I)(aa) 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;
                            ``(bb) classified in category III for 
                        safety or effectiveness in the preamble of a 
                        proposed rule establishing such tentative final 
                        monograph;
                            ``(cc) 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, the general 
                        requirements for nonprescription drugs, and the 
                        requirements under subsections (c) and (j); and
                            ``(dd) in a dosage form that, as of the day 
                        before the date of enactment of the Over-the-
                        Counter Drug Safety, Innovation, and Reform 
                        Act, has been used to a material extent and for 
                        a material time within the meaning of section 
                        201(p)(2); or
                            ``(II)(aa) 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;
                            ``(bb) classified in category I for safety 
                        and effectiveness under such proposed monograph 
                        or advance notice of proposed rulemaking;
                            ``(cc) 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, the general requirements 
                        for nonprescription drugs, and the requirements 
                        under subsections (c) and (j); and
                            ``(dd) in a dosage form that, as of the day 
                        before the date of enactment of the Over-the-
                        Counter Drug Safety, Innovation, and Reform Act 
                        has been used to a material extent and for a 
                        material time within the meaning of section 
                        201(p)(2).
                    ``(C)(i) Subject to clause (iii), beginning on the 
                date that is 180 calendar days after the date of 
                enactment of the Over-the-Counter Drug Safety, 
                Innovation, and Reform Act, a nonprescription drug is 
                deemed to be not generally recognized as safe and 
                effective within the meaning of section 201(p)(1), a 
                new drug under section 201(p), and misbranded under 
                section 502(ee), if such drug--
                            ``(I) is classified in category II for 
                        safety or effectiveness under a tentative final 
                        monograph; or
                            ``(II) is subject to a determination to be 
                        not generally recognized as safe and effective 
                        under a proposed rule that is the most recently 
                        applicable proposal issued under part 330 of 
                        title 21, Code of Federal Regulations.
                    ``(ii) A nonprescription drug that the Secretary 
                has determined to be not generally recognized as safe 
                and effective under a final determination issued under 
                part 330 of title 21, Code of Federal Regulations is 
                deemed to be not generally recognized as safe and 
                effective within the meaning of section 201(p)(1), a 
                new drug under section 201(p), and misbranded under 
                section 502(ee).
                    ``(iii) A 180-day period described in clause (i) 
                may be extended with respect to a drug by the Secretary 
                if the Secretary determines that such extension is in 
                the interest of the public health.
                    ``(D) 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).
            ``(2) New drugs.--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--
                    ``(A) not described in subparagraph (A), (B), (C), 
                or (D) of paragraph (1) and not in conformity with 
                subsection (d), as applicable; or
                    ``(B) not a nonprescription sunscreen active 
                ingredient or combination of ingredients subject to a 
                final sunscreen order, as defined in section 586(2).
            ``(3) Monograph drug.--In this section, the term `monograph 
        drug' has the meaning given such term in section 744L.
            ``(4) Rules of construction.--
                    ``(A) In general.--This section shall not affect 
                the treatment or status of a nonprescription drug 
                subject to section 505--
                            ``(i) 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
                            ``(ii) to which subparagraphs (A), (B), 
                        (C), and (D) of paragraph (1) do not apply.
                    ``(B) Applicability of other provisions.--Nothing 
                in this paragraph shall be construed to preclude or 
                limit the applicability of any other provision of this 
                Act.
                    ``(C) No effect on other authorities.--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.
    ``(c) Administrative Orders.--
            ``(1) In general.--
                    ``(A) 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--
                            ``(i) not subject to section 503(b)(1);
                            ``(ii) generally recognized as safe and 
                        effective within the meaning of section 
                        201(p)(1); and
                            ``(iii) not required to be approved under 
                        section 505.
                    ``(B) Not generally recognized as safe and 
                effective.--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 the 
                Secretary determines that--
                            ``(i) the evidence shows that the drug is 
                        not generally recognized as safe and effective 
                        within the meaning of section 201(p)(1); or
                            ``(ii) the evidence is inadequate to show 
                        that the drug is generally recognized as safe 
                        and effective within the meaning of section 
                        201(p)(1).
            ``(2) Administrative orders initiated by the secretary; 
        citizen petitions.--
                    ``(A) In general.--Except as provided in paragraph 
                (5), in issuing an administrative order under paragraph 
                (1) on the initiative of the Secretary, the Secretary 
                shall--
                            ``(i) 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 have a listing in 
                        effect under section 510(j) for drugs will be 
                        subject to such order;
                            ``(ii) after making any such informal 
                        communication--
                                    ``(I) 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
                                    ``(II) publish notice of 
                                availability of such proposed order in 
                                the Federal Register;
                            ``(iii) 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
                            ``(iv) if, after satisfying the 
                        requirements of clauses (i) through (iii), the 
                        Secretary determines that it is appropriate to 
                        issue a final administrative order--
                                    ``(I) 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;
                                    ``(II) publish a notice of 
                                availability of such final 
                                administrative order in the Federal 
                                Register;
                                    ``(III) 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
                                    ``(IV) except with respect to drugs 
                                described in paragraph (3)(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.
                    ``(B) Special requirements with respect to certain 
                monograph drugs.--When issuing an administrative order 
                under paragraph (1) on the initiative of the Secretary 
                (except as provided under paragraph (4)) 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--
                            ``(i) the proposed order shall include 
                        notice of--
                                    ``(I) 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
                                    ``(II) the format for submissions 
                                by interested persons;
                            ``(ii) 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
                            ``(iii) 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).
                    ``(C) Citizen petitions.--
                            ``(i) In general.--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).
                            ``(ii) Effect of petition.--Nothing in 
                        clause (i) shall be construed to provide an 
                        alternative to, or otherwise supplant or 
                        supersede--
                                    ``(I) the processes through which a 
                                requestor may seek an administrative 
                                order pursuant to paragraph (5); or
                                    ``(II) the fee structure under 
                                section 744L-1(a)(2).
            ``(3) Hearings; judicial review.--
                    ``(A) In general.--A person who participated in 
                each level of formal dispute resolution under paragraph 
                (2)(A)(iv)(III) of an administrative order with respect 
                to a drug may request a hearing concerning a final 
                administrative order issued under paragraph (2)(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.
                    ``(B) No hearing required with respect to orders 
                relating to certain drugs.--The Secretary is not 
                required to provide notice and an opportunity for a 
                hearing pursuant to paragraph (2)(A)(iv) if the final 
                administrative order involved relates to a drug--
                            ``(i) that is described in subsection 
                        (b)(1)(B)(ii)(I); and
                            ``(ii) 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 (6)).
                    ``(C) Hearing procedures.--
                            ``(i) Denial of request for hearing.--If 
                        the Secretary determines that a request for a 
                        hearing under subparagraph (A) with respect to 
                        a final administrative order issued under 
                        paragraph (2)(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.
                            ``(ii) Single hearing for multiple related 
                        requests.--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.
                            ``(iii) Presiding officer.--The Secretary 
                        shall designate a presiding officer of a 
                        hearing requested under subparagraph (A) who--
                                    ``(I) is not an employee of the 
                                Center for Drug Evaluation and 
                                Research; and
                                    ``(II) has not previously been 
                                involved in the development of the 
                                applicable administrative order or in 
                                the proceedings relating to that 
                                administrative order.
                            ``(iv) Rights of parties to hearing.--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.
                            ``(v) Final decision.--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.
                    ``(D) Judicial review of final administrative 
                order.--
                            ``(i) In general.--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.
                            ``(ii) Time to submit a request for 
                        judicial review.--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--
                                    ``(I) the date on which notice of 
                                such order is published;
                                    ``(II) the date on which any 
                                hearing with respect to such order is 
                                denied under subparagraph (C)(i);
                                    ``(III) the date on which a final 
                                decision is made following any hearing 
                                with respect to such order under 
                                subparagraph (C)(v); or
                                    ``(IV) if no hearing is requested, 
                                the date on which the time for 
                                requesting a hearing expires.
            ``(4) Expedited procedure with respect to administrative 
        orders initiated by the secretary.--
                    ``(A) Imminent hazard to the public health.--
                            ``(i) In general.--In the case of a 
                        determination by the Secretary that a monograph 
                        drug poses an imminent hazard to the public 
                        health, the Secretary, after informally 
                        communicating with any sponsor that has a 
                        listing in effect under section 510(j) for such 
                        drug not later than 48 hours before issuance of 
                        an order under this subparagraph, may--
                                    ``(I) 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;
                                    ``(II) publish in the Federal 
                                Register a notice of availability of 
                                such order; and
                                    ``(III) provide for a public 
                                comment period of at least 45 calendar 
                                days after issuance of such interim 
                                final order.
                            ``(ii) Nondelegation.--The Secretary may 
                        not delegate the authority to issue an interim 
                        final administrative order under this 
                        subparagraph.
                    ``(B) Safety labeling changes.--
                            ``(i) In general.--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--
                                    ``(I) informally communicate, not 
                                later than 48 hours before issuance of 
                                an interim final order under this 
                                subparagraph any sponsors of a drug who 
                                has a listing in effect under section 
                                510(j) for such drug or combination of 
                                drugs;
                                    ``(II) after informally 
                                communicating with the sponsors under 
                                subclause (I), issue an interim final 
                                administrative order under paragraph 
                                (1) to require such change, together 
                                with a detailed statement of the 
                                reasons for such order and, in the case 
                                of a required change to the packaging, 
                                a brief description of the factors 
                                considered in accordance with paragraph 
                                (7)(B)(i);
                                    ``(III) publish in the Federal 
                                Register a notice of availability of 
                                such order; and
                                    ``(IV) provide for a public comment 
                                period of at least 45 calendar days 
                                after issuance of such interim final 
                                order.
                            ``(ii) Content of 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.
                    ``(C) Effective date.--An order under subparagraph 
                (A) or (B) shall take effect on a date specified by the 
                Secretary.
                    ``(D) Final order.--After the completion of the 
                proceedings in subparagraph (A) or (B), the Secretary 
                shall--
                            ``(i) issue a final order in accordance 
                        with paragraph (1);
                            ``(ii) publish a notice of availability of 
                        such final administrative order in the Federal 
                        Register; and
                            ``(iii) 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.
                    ``(E) Hearings.--
                            ``(i) In general.--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 (3) 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 (2)(A)(iv), except 
                        that, with respect to a final order issued 
                        under subparagraph (D), the final decision 
                        under paragraph (3)(C)(v) may take effect prior 
                        to the expiration of the period under paragraph 
                        (3)(D)(ii) for submitting a request for 
                        judicial review.
                            ``(ii) References.--For purposes of a 
                        hearing under this subparagraph, the references 
                        in subparagraphs (A), (B), and (C) of paragraph 
                        (3)--
                                    ``(I) to `each level of dispute 
                                resolution under paragraph 
                                (2)(A)(iv)(III)' shall be deemed to 
                                mean `each level of formal dispute 
                                resolution under subparagraph 
                                (D)(iii)'; and
                                    ``(II) to `final administrative 
                                order issued under paragraph 
                                (2)(A)(iv)' shall be deemed to mean 
                                `final order under subparagraph 
                                (D)(i)'.
                    ``(F) Final order.--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.
                    ``(G) Judicial review.--A final order issued 
                pursuant to subparagraph (F) shall be subject to 
                judicial review in accordance with paragraph (3)(D).
                    ``(H) Clarification.--Paragraph (2) shall not apply 
                to the orders issued under this paragraph.
            ``(5) Administrative order initiated by request.--
                    ``(A) In general.--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--
                            ``(i) the Secretary shall, after receiving 
                        a request under this subparagraph, determine 
                        whether the request is sufficiently complete 
                        and formatted to permit a substantive review;
                            ``(ii) subject to subparagraph (D), if the 
                        Secretary determines that the request is 
                        sufficiently complete and formatted to permit a 
                        substantive review, the Secretary shall--
                                    ``(I) file the request; and
                                    ``(II) initiate proceedings with 
                                respect to issuing an administrative 
                                order in accordance with paragraphs (2) 
                                and (3); and
                            ``(iii) 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 (2)(A).
                    ``(B) Request to initiate proceedings.--
                            ``(i) In general.--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--
                                    ``(I) 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
                                    ``(II) 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--
                                            ``(aa) described in 
                                        subsection (b)(1)(A); or
                                            ``(bb) 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 paragraph (1)(B), 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.
                            ``(ii) Withdrawal of request.--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 may cease 
                        proceedings under this subparagraph.
                    ``(C) Product differentiation.--
                            ``(i) In general.--A final administrative 
                        order issued in response to a request under 
                        this paragraph shall have the effect of 
                        authorizing solely the order requestor (or the 
                        licensees, assignees, or successors in interest 
                        of such requestor with respect to the subject 
                        of such order and listed under clause (v)), for 
                        a 2-year period beginning on the effective date 
                        of such order, to market drugs under this 
                        section--
                                    ``(I) incorporating changes 
                                described in clause (ii); and
                                    ``(II) subject to the limitations 
                                under clause (iv).
                            ``(ii) Changes described.--A change 
                        described in this clause is a change subject to 
                        an order specified in clause (i), which--
                                    ``(I) provides for a drug to 
                                contain an active ingredient (including 
                                any ester or salt of the active 
                                ingredient) not previously incorporated 
                                in a drug described in clause (iii); or
                                    ``(II) provides for a change in the 
                                conditions of use of a drug, for which 
                                new 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.
                            ``(iii) Drugs described.--The drugs 
                        described in this clause are drugs--
                                    ``(I) specified in subparagraphs 
                                (A), (B), and (D) of subsection (b)(1);
                                    ``(II) subject to a final order 
                                issued under this section;
                                    ``(III) subject to a final 
                                sunscreen order (as defined in section 
                                586(2)(A)); or
                                    ``(IV) described in subsection 
                                (b)(4)(A), other than drugs subject to 
                                an active enforcement action under 
                                chapter III.
                            ``(iv) Limitations on product 
                        differentiation.--
                                    ``(I) Only one period.--Only one 2-
                                year period under this subparagraph 
                                shall be granted for each order 
                                described in clause (i) with respect to 
                                changes (to the drug subject to such 
                                order) that are--
                                            ``(aa) changes described in 
                                        clause (ii)(I), relating to 
                                        active ingredients; or
                                            ``(bb) changes described in 
                                        clause (ii)(II), relating to 
                                        conditions of use.
                                    ``(II) Exclusions.--No 2-year 
                                period under this subparagraph shall 
                                apply to changes to a drug that are--
                                            ``(aa) the subject of a 
                                        `Tier 2' monograph drug order 
                                        requested as described in 
                                        section 744L(14)(A);
                                            ``(bb) safety-related 
                                        changes described in section 
                                        744L-1(a)(2)(C), required under 
                                        this paragraph, or any other 
                                        change the Secretary determines 
                                        necessary to ensure safe use; 
                                        or
                                            ``(cc) changes related to 
                                        methods of testing safety or 
                                        efficacy.
                            ``(v) Listing of licensees, assignees, or 
                        successors in interest.--The requestors of an 
                        order described in clause (i) shall, as 
                        applicable, submit to the Secretary, at a time 
                        when a drug subject to such order is introduced 
                        or delivered for introduction into interstate 
                        commerce, a list of licensees, assignees, or 
                        successors in interest under such clause.
                            ``(vi) New human data studies defined.--For 
                        purposes of this subparagraph, the term `new 
                        human data studies' means studies from clinical 
                        trials of safety or effectiveness, 
                        pharmacokinetics studies, or bioavailability 
                        studies, the results of which--
                                    ``(I) the Secretary has not relied 
                                on to support--
                                            ``(aa) a proposed or final 
                                        determination that a drug 
                                        described in subclauses (I), 
                                        (II), or (III) of clause (iii) 
                                        is generally recognized as safe 
                                        and effective within the 
                                        meaning of section 201(p)(1); 
                                        or
                                            ``(bb) approval of a drug 
                                        under section 505; and
                                    ``(II) do not duplicate the results 
                                of another study that the Secretary 
                                relied on to support--
                                            ``(aa) a proposed or final 
                                        determination that a drug 
                                        described in subclause (I), 
                                        (II), or (III) of clause (iii) 
                                        is generally recognized as safe 
                                        and effective within the 
                                        meaning of section 201(p)(1); 
                                        or
                                            ``(bb) approval of a drug 
                                        that was approved under section 
                                        505.
                    ``(D) Information regarding safe nonprescription 
                marketing and use as a condition for filing a grase 
                request.--
                            ``(i) In general.--In response to a request 
                        under this paragraph that a drug described in 
                        clause (ii) be generally recognized as safe and 
                        effective, the Secretary--
                                    ``(I) 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
                                    ``(II) 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).
                            ``(ii) Drug described.--A drug described in 
                        this clause is a monograph drug that contains 
                        an active ingredient not previously 
                        incorporated in a drug--
                                    ``(I) described in subparagraph 
                                (A), (B), or (D) of subsection (b)(1);
                                    ``(II) subject to a final order 
                                under this section; or
                                    ``(III) subject to a final 
                                sunscreen order (as defined in section 
                                586(2)(A)).
                            ``(iii) Sufficient information for a 
                        threshold demonstration of nonprescription 
                        marketing and use.--Information specified in 
                        this subparagraph, with respect to a request 
                        described in clause (i)(I), is--
                                    ``(I) 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;
                                    ``(II) 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--
                                            ``(aa) for such period of 
                                        time as needed to provide 
                                        reasonable assurances 
                                        concerning the safe 
                                        nonprescription use of the 
                                        drug; and
                                            ``(bb) 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
                                    ``(III) 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.
                            ``(iv) Marketing pursuant to new drug 
                        application.--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--
                                    ``(I) the drug is marketed as a 
                                nonprescription drug, under conditions 
                                of use comparable to the requirements 
                                specified in the request, for such 
                                period of time as the Secretary 
                                determines appropriate (not to exceed 5 
                                consecutive years) pursuant to an 
                                application approved under section 505; 
                                and
                                    ``(II) 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.
                            ``(v) Rule of application.--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.
            ``(6) Treatment of final and tentative final monographs.--
                    ``(A) In general.--A final monograph or tentative 
                final monograph described in subparagraph (B) 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.
                    ``(B) Monographs described.--For purposes of 
                subparagraph (A), a final monograph or tentative final 
                monograph, as applicable, is described in this 
                subparagraph if such monograph--
                            ``(i) establishes requirements of use for a 
                        drug described in subclause (I) or (II) of 
                        subsection (b)(1)(A)(i); and
                            ``(ii) represents the most recently 
                        promulgated version of such requirements, 
                        including as modified, in whole or in part, by 
                        any proposed or final rule.
            ``(7) Packaging.--
                    ``(A) In general.--An administrative order issued 
                under paragraph (2), (4), or (5) 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 overdose or 
                accidental ingestion, including by pediatric 
                populations.
                    ``(B) Safety labeling changes.--An administrative 
                order issued under paragraph (4)(B) that includes 
                requirements for the packaging of a drug may be issued 
                only after--
                            ``(i) consideration of--
                                    ``(I) whether labeling changes 
                                alone would mitigate a significant or 
                                unreasonable risk of a serious adverse 
                                event; and
                                    ``(II) as appropriate, any of the 
                                applicable nonprescription drugs 
                                currently available; and
                            ``(ii) consultation with sponsors on the 
                        impact of the removal of such drugs without 
                        such packaging and the change of such packaging 
                        on patients and manufacturers when establishing 
                        such requirements.
                    ``(C) Clarification.--This paragraph does not 
                authorize the Secretary to require standards or testing 
                procedures as described in part 1700 of title 16, Code 
                of Federal Regulations.
    ``(d) Procedure for Minor Changes.--
            ``(1) In general.--Minor changes in the dosage form of a 
        drug that is described in subparagraph (A) or (B) of subsection 
        (b)(1) may be made by a requestor without the issuance of an 
        administrative order under subsection (c) if--
                    ``(A) the requestor maintains information necessary 
                to demonstrate that the change--
                            ``(i) will not affect the safety or 
                        effectiveness of the drug; and
                            ``(ii) will not materially affect the 
                        extent of absorption or other exposure to the 
                        active ingredient in comparison to a suitable 
                        reference product;
                    ``(B) 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
                    ``(C) the change is in conformity with the 
                requirements of an applicable administrative order 
                issued by the Secretary under paragraph (3).
            ``(2) Additional information.--
                    ``(A) Access to records.--If the Secretary requests 
                records under section 704(a)(4) with respect to a minor 
                change made to a drug by a requestor under this 
                subsection, any such records pertinent to such drug, 
                such minor change, and the requestor shall be provided 
                to the Secretary by the requestor within 15 business 
                days of receiving such request, or such longer period 
                as the Secretary may provide.
                    ``(B) Insufficient information.--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--
                            ``(i) may so inform the requestor of the 
                        drug in writing; and
                            ``(ii) provide the requestor of the drug 
                        with a reasonable opportunity to provide 
                        additional information.
                    ``(C) Failure to submit sufficient 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).
            ``(3) Determining whether change will affect safety or 
        effectiveness.--
                    ``(A) In general.--The Secretary shall issue one or 
                more administrative orders under this subsection 
                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.
                    ``(B) Standard practices and special needs of 
                populations.--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.
    ``(e) Information Submitted by Requestors.--
            ``(1) Confidential information.--Subject to paragraph (2), 
        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.
            ``(2) Public availability limitations.--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--
                    ``(A) 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);
                    ``(B) 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
                    ``(C) the Secretary requests and obtains the 
                information under subsection (d) and such information 
                is not submitted in relation to an order under 
                subsection (c).
    ``(f) Public Availability of Administrative Orders.--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--
            ``(1) 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
            ``(2) a listing of all administrative orders proposed and 
        under development on the initiative of the Secretary under this 
        section, including--
                    ``(A) a brief description of the administrative 
                order; and
                    ``(B) the expectations of the Secretary, for 
                issuance of proposed administrative orders over a 3-
                year period.
    ``(g) Updates to Drug Listing Information.--A sponsor who makes a 
change to a drug subject to this section shall submit updated drug 
listing information for the drug in accordance with the requirements of 
section 510(j) not later than the date on which the drug is first 
introduced or delivered for introduction into interstate commerce with 
the change.
    ``(h) Approvals Under Section 505.--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.
    ``(i) Development Advice to Requestors or Sponsors.--
            ``(1) In general.--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 
        and development of monograph drugs under this section.
            ``(2) Participation of multiple sponsors.--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.
            ``(3) Private meetings with requestors.--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.
    ``(j) Effect on Existing Regulations Governing Nonprescription 
Drugs.--
            ``(1) Regulations of general applicability to 
        nonprescription drugs.--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.
            ``(2) Regulations establishing requirements for specific 
        nonprescription drugs.--
                    ``(A) In general.--Section 310.545 of title 21, 
                Code of Federal Regulations, as in effect on the day 
                before the date of enactment of this section, shall be 
                deemed to be final administrative order under 
                subsection (c).
                    ``(B) Other regulations.--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 subject to this section.
                    ``(C) Effective date period.--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).
            ``(3) Withdrawal of regulations.--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 the Over-the-Counter Drug Safety, Innovation, and 
        Reform 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).
    ``(k) Guidance.--
            ``(1) Issuance.--The Secretary shall issue guidance that 
        provides--
                    ``(A) the procedures and principles for formal 
                meetings between the Secretary and sponsors or 
                requestors for drugs subject to this section;
                    ``(B) the format and content of data submissions to 
                the Secretary under this section;
                    ``(C) the format of electronic submissions to the 
                Secretary under this section;
                    ``(D) consolidated proceedings and the procedures 
                for such proceedings where appropriate; and
                    ``(E) for minor changes in drugs, recommendations 
                on how to comply with the requirements in 
                administrative orders issued under subsection 
                (d)(3)(A).
    ``(l) Electronic Format.--All submissions under this section shall 
be in an electronic format specified by the Secretary after providing a 
period for public comment.
    ``(m) Inapplicability of Paperwork Reduction Act.--Chapter 35 of 
title 44, United States Code, shall not apply to collections of 
information made under this section.
    ``(n) Nonapplication of Certain Requirements.--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.
    ``(o) Investigational New Drugs.--A drug for which an exemption 
under section 505(i) is in effect is not subject to this section.''.

SEC. 102. MISBRANDING.

    Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352) is amended by inserting after subsection (dd) the following:
    ``(ee) If it is a nonprescription drug that is not the subject of 
an application approved under section 505, and does not comply with the 
requirements under section 505G.
    ``(ff) If it is a drug for which fees under section 744L-1 have 
been assessed but have not been paid.''.

SEC. 103. CONFORMING AMENDMENTS TO THE SUNSCREEN INNOVATION ACT.

    (a) Review of Nonprescription Ingredients Subject to Sunscreen 
Innovation Act.--
            (1) Pending sunscreen ingredients.--Nonprescription 
        sunscreen active ingredients or combinations of sunscreen 
        active ingredients for use under specified conditions subject, 
        on the date of enactment of this Act, to a proposed sunscreen 
        order, as defined in section 586(7) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360fff(7)), shall--
                    (A) continue to be reviewed in accordance with 
                section 586C of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360fff-3); or
                    (B) be reviewed under section 505G of such Act upon 
                written notification of the Secretary by the sponsor 
                within 180 calendar days after the date of enactment of 
                the Over-the-Counter Drug Safety, Innovation, and 
                Reform Act that such sponsor elects to have such 
                ingredient or combination of ingredients reviewed under 
                such section 505G, and, upon notification, such 
                proposed sunscreen order under such section 586C shall 
                be considered to be a request for an administrative 
                order that has been accepted for filing under section 
                505G(c)(6)(A)(ii) of such Act.
            (2) Pending nonsunscreen ingredients.--
                    (A) In general.--Any application described in 
                section 586F of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360fff-6) that was submitted to the 
                Secretary of Health and Human Services pursuant to 
                section 330.14 of title 21, Code of Federal Regulations 
                (as such provisions were in effect on the day before 
                the date of enactment of this Act), shall be voided as 
                of such date of enactment, subject to subparagraph (B).
                    (B) Order request.--Nothing in subparagraph (A) 
                precludes the submission of an order request under 
                section 505G(b) of the Federal Food, Drug, and Cosmetic 
                Act, as added by section 101 of this Act, with respect 
                to a drug that was the subject of an application voided 
                under subparagraph (A).
                    (C) Ingredients submitted after the date of 
                enactment of section 506g.--Any ingredient that is 
                eligible for review under section 505G of the Federal 
                Food, Drug, and Cosmetic Act and is submitted after the 
                date of enactment of this Act shall be considered under 
                that section.
    (b) Meetings Regarding Sunscreen Ingredients.--Section 586C(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is 
amended by adding at the end the following:
            ``(11) Meetings with sponsors.--A sponsor may request an 
        individual, confidential meeting to discuss the data 
        requirements to support a general recognition of safety and 
        effectiveness with respect to the subject of a pending 
        sunscreen ingredient. The Secretary shall respond within 14 
        calendar days of the request and schedule such meeting within 
        45 calendar days, or within such timeline as specified in the 
        letters described in section 201 of the Over-the-Counter Drug 
        Safety, Innovation, and Reform Act. If a sponsor requests more 
        than one confidential meeting for the same proposed sunscreen 
        order, the Secretary may refuse to grant an additional 
        confidential meeting request if the Secretary determines such 
        additional confidential meeting is not reasonably necessary for 
        the sponsor to advance the proposed sunscreen order, or if the 
        sponsor does not provide sufficient information upon which to 
        base a substantive discussion. The Secretary shall publish a 
        post-meeting summary on the internet website of the Food and 
        Drug Administration of any confidential meeting that does not 
        disclose confidential business information.''.
    (c) Product Differentiation.--Section 586C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at the 
end the following:
    ``(f) Product Differentiation.--
            ``(1) In general.--A final sunscreen order shall have the 
        effect of authorizing solely the order requestor (or the 
        licensees, assignees, or successors in interest of such 
        requestor with respect to the subject of such request and 
        listed under paragraph (5)) for a period of 2 years, to market 
        a sunscreen ingredient under this section incorporating changes 
        described in paragraph (2) subject to the limitations under 
        paragraph (4), beginning on the date the requestor (or any 
        licensees, assignees, or successors in interest of such 
        requestor with respect to the subject of such request and 
        listed under paragraph (5)) may lawfully market such sunscreen 
        ingredient pursuant to the order.
            ``(2) Changes described.--A change described in this 
        paragraph is a change subject to an order specified in 
        paragraph (1) that permits a sunscreen to contain an active 
        sunscreen ingredient not previously incorporated in a marketed 
        sunscreen listed in paragraph (3).
            ``(3) Marketed sunscreen.--The marketed sunscreen 
        ingredients described this paragraph are sunscreen 
        ingredients--
                    ``(A) marketed in accordance with a final monograph 
                for sunscreen drug products set forth at part 352 of 
                title 21, Code of Federal Regulations (as published at 
                64 Fed. Reg. 27687); or
                    ``(B) marketed in accordance with a final order 
                issued under this section.
            ``(4) Limitations on product differentiation.--Only one 2-
        year period may be granted per ingredient under paragraph (1).
            ``(5) Listing of licensees, assignees, or successors in 
        interest.--Requestors shall submit to the Secretary at the time 
        when a drug subject to such request is introduced or delivered 
        for introduction into interstate commerce, a list of licensees, 
        assignees, or successors in interest under paragraph (1).''.
    (d) Sunscreen Innovation Act Amendments.--Section 586C(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(e)) is amended 
by striking paragraph (3) and inserting the following:
            ``(3) Relationship to orders under section 505g.--A final 
        sunscreen order shall be deemed to be a final administrative 
        order under section 505G and subject to the applicable 
        provisions under such section 505G, including with respect to 
        amendment of such order.''.
    (e) Preclusion of New Sunscreen Submissions; Option To Transfer 
Submissions to OTC Monograph Order Process.--
            (1) Sunset.--Beginning on the date of enactment of this 
        Act, section 586A of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360fff-1) shall have no force or effect.
            (2) Option to transfer submissions to otc monograph order 
        process.--
                    (A) In general.--Any person who submitted a request 
                described in subparagraph (B) may, at any time prior to 
                the sunset of subchapter I of chapter V of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.) 
                under section 586H of such Act, withdraw such request 
                from the process under such subchapter and resubmit 
                such request as an order request under section 505G of 
                such Act.
                    (B) Requests.--A request described in this 
                subparagraph is--
                            (i) a request under section 586A of the 
                        Federal Food, Drug, and Cosmetic Act submitted 
                        before the date of enactment of this Act; or
                            (ii) a pending request described in section 
                        586(6).
    (f) Treatment of Authority Regarding Finalization of Sunscreen 
Monograph.--Section 586E of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff-5) is amended to read as follows:

``SEC. 586E. SUNSCREEN ORDER.

    ``(a) In General.--
            ``(1) Revision of final sunscreen order.--Not later than 
        November 26, 2019, the Secretary shall amend and revise the 
        final administrative order concerning nonprescription sunscreen 
        (referred to in this section as the `sunscreen order') for 
        which the substance, prior to the date of enactment of the 
        Over-the-Counter Drug Safety, Innovation, and Reform Act, was 
        marketed in accordance with a final monograph for sunscreen 
        drug products set forth in part 352 of title 21, Code of 
        Federal Regulations (as published at 64 Fed. Reg. 27687)
            ``(2) Issuance of revised sunscreen order; effective 
        date.--A revised sunscreen order described in paragraph (1) 
        shall be--
                    ``(A) issued in accordance with the procedures 
                described in section 505G(c)(2);
                    ``(B) issued in proposed form not later than May 
                28, 2019;
                    ``(C) effective not later than November 26, 2020; 
                and
                    ``(D) issued by the Secretary at least 1 year prior 
                to such effective date.
    ``(b) Reports.--If a revised sunscreen order issued under 
subsection (a) does not include provisions related to the effectiveness 
of various sun protection factor levels, and does not address all 
dosage forms known to the Secretary to be used in sunscreens marketed 
in the United States without a new drug application approved under 
section 505, the Secretary shall submit 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 on the rationale 
for omission of such provisions from such order, and a plan and 
timeline to compile any information necessary to address such 
provisions through such order.''.
    (g) Sunset of Process Under Sunscreen Innovation Act.--Subchapter I 
of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360fff et seq.), as amended by subsection (f), is further amended by 
inserting at the end the following new section:

``SEC. 586H. SUNSET.

    ``This subchapter shall no longer be effective upon the later of--
            ``(1) a final determination by the Secretary under this 
        subchapter with respect to every request described in section 
        586A(b)(2) (other than any withdrawn requests and requests 
        resubmitted as order requests under section 505G); or
            ``(2) the effective date of the revised sunscreen order 
        described in section 586E(a)(2).''.

SEC. 104. DRUGS EXCLUDED FROM OVER-THE-COUNTER REVIEW.

    (a) In General.--Nothing in this Act (or the amendments made by 
this Act) shall apply to any nonprescription drug which was excluded by 
the Food and Drug Administration from the Over-the-Counter Drug Review 
in accordance with the statement set out at page 9466 of volume 37 of 
the Federal Register, published on May 11, 1972.
    (b) Rule of Construction.--Nothing in this section shall be 
construed to preclude or limit the applicability of any provision of 
the Federal Food, Drug, and Cosmetic Act.

SEC. 105. CONFORMING AMENDMENT.

    Section 751(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379r(d)(1)) is amended--
            (1) in the matter preceding subparagraph (A)--
                    (A) by striking ``final regulation promulgated'' 
                and inserting ``final order issued under section 
                505G''; and
                    (B) by striking ``and not misbranded''; and
            (2) in subparagraph (A), by striking ``regulation in 
        effect'' and inserting ``regulation or order in effect''.

SEC. 106. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC INDICATION 
              FOR CERTAIN COUGH AND COLD MONOGRAPH DRUGS.

    (a) In General.--Not later than one year after the date of 
enactment of this Act and annually thereafter, the Secretary of Health 
and Human Services (referred to in this section as the ``Secretary'') 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a letter describing the progress of the Food and Drug 
Administration--
            (1) in evaluating the cough and cold monograph described in 
        subsection (b) with respect to children under age 6; and
            (2) as appropriate, revising such cough and cold monograph 
        to address such children, through the administrative order 
        process under section 505G(c) of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 101.
    (b) Cough and Cold Monograph Described.--The cough and cold 
monograph described in this subsection consists of the conditions under 
which nonprescription drug products containing antitussive, 
expectorant, nasal decongestant, or antihistamine active ingredients 
(or combinations thereof) are generally recognized as safe and 
effective, as specified in part 341 of title 21, Code of Federal 
Regulations (as in effect on the day before the date of enactment of 
this Act), and included in an administrative order deemed established 
under such section 505G(c) of the Federal Food, Drug, and Cosmetic Act.
    (c) Duration of Authority.--Subsection (a) shall have no force or 
effect beginning on the date on which the Secretary submits a letter 
under subsection (a) in which the Secretary indicates that the Food and 
Drug Administration has completed its evaluation and revised, in a 
final administrative order, as applicable, the cough and cold monograph 
in accordance with this section.

               TITLE II--FEES RELATING TO MONOGRAPH DRUGS

SEC. 201. SHORT TITLE; FINDINGS.

    (a) Short Title.--This title may be cited as the ``Over-the-Counter 
Monograph User Fee Act of 2018''.
    (b) Findings.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated toward the regulation 
of monograph drugs under section 505G of the Federal, Food, Drug, and 
Cosmetic Act, as set forth in the goals identified for purposes of such 
section, in the letters from the Secretary of Health and Human Services 
to the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Committee on Energy and 
Commerce of the House of Representatives, as set forth in the 
Congressional Record.

SEC. 202. AUTHORITY TO ASSESS AND USE FEES.

    Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379f et seq.) is amended by adding at the end the 
following:

              ``PART 10--FEES RELATING TO MONOGRAPH DRUGS

``SEC. 744L. DEFINITIONS.

    ``For purposes of this part:
            ``(1) The term `affiliate' means a business entity that has 
        a relationship with a second business entity if, directly or 
        indirectly--
                    ``(A) one business entity controls, or has the 
                power to control, the other business entity; or
                    ``(B) a third party controls, or has power to 
                control, both of the business entities.
            ``(2) the term `contract manufacturing organization 
        facility' means a monograph drug facility where neither the 
        owner of such manufacturing facility nor any affiliate of such 
        owner or facility sells such monograph drug produced at such 
        facility directly to wholesalers, retailers, or consumers in 
        the United States.
            ``(3) The term `costs of resources allocated for monograph 
        drug activities' means the expenses in connection with 
        monograph drug activities for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies; and
                    ``(D) collecting fees under section 744L-1 and 
                accounting for resources allocated for monograph drug 
                activities.
            ``(4) The term `firm establishment identifier' is the 
        unique number automatically generated by the Field 
        Accomplishments and Compliance Tracking System of the Food and 
        Drug Administration.
            ``(5) The term `monograph drug' means a drug subject to 
        section 505G.
            ``(6) The term `monograph drug activities' means activities 
        of the Secretary associated with monograph drugs and inspection 
        of facilities associated with such drugs, including--
                    ``(A) the activities necessary for review and 
                evaluation of monograph drugs and monograph drug order 
                requests, including--
                            ``(i) orders proposing or finalizing 
                        applicable requirements for monograph drugs;
                            ``(ii) orders affecting status regarding 
                        general recognition of safety and effectiveness 
                        of a monograph drug ingredient or combination 
                        of ingredients under specified requirements;
                            ``(iii) all monograph drug development and 
                        review activities, including intra-agency 
                        collaboration;
                            ``(iv) regulation and policy development 
                        activities related to monograph drugs;
                            ``(v) development of product standards for 
                        drugs subject to review and evaluation;
                            ``(vi) meetings regarding monograph drug 
                        activities;
                            ``(vii) review of labeling prior to 
                        issuance of orders related to monograph drugs 
                        or conditions of use; and
                            ``(viii) regulatory science activities 
                        related to monograph drugs;
                    ``(B) inspections related to monograph drugs;
                    ``(C) monitoring of clinical and other research 
                conducted in connection with monograph drugs;
                    ``(D) safety activities with respect to monograph 
                drugs, including--
                            ``(i) collecting, developing, and reviewing 
                        safety information on monograph drugs, 
                        including adverse event reports;
                            ``(ii) developing and using improved 
                        adverse event data-collection systems, 
                        including information technology systems; and
                            ``(iii) developing and using improved 
                        analytical tools to assess potential safety 
                        risks, including access to external databases; 
                        and
                    ``(E) other activities necessary for implementation 
                of section 505G.
            ``(7)(A) The term `monograph drug facility' means a foreign 
        or domestic business or other entity--
                    ``(i) that is under one management, either direct 
                or indirect;
                    ``(ii) at one geographic location or address 
                engaged in manufacturing or processing a monograph drug 
                in finished dosage form;
                    ``(iii) includes a finished dosage form 
                manufacturer facility or an affiliate thereof in a 
                contractual relationship with a monograph drug 
                requestor or requestors to manufacture or process 
                monograph drugs; and
                    ``(iv) does not include a business or other entity 
                whose only manufacturing or processing activities 
                relate to--
                            ``(I) production of clinical research 
                        supplies;
                            ``(II) testing; or
                            ``(III) placement of outer overpackaging on 
                        packages containing multiple products, for such 
                        purposes as creating multipacks, when each 
                        monograph drug product contained within the 
                        overpackaging is already in a final packaged 
                        form prior to placement in the outer 
                        overpackaging.
            ``(B) For purposes of subparagraph (A), separate buildings 
        or locations within close proximity are considered to be at 1 
        geographic location or address if the activities conducted in 
        them are--
                    ``(i) closely related to the same business 
                enterprise;
                    ``(ii) under the supervision of the same local 
                management; and
                    ``(iii) under a single firm establishment 
                identifier and capable of being inspected by the Food 
                and Drug Administration during a single inspection.
            ``(C) If a business or other entity would meet the 
        definition of a facility under this paragraph but for being 
        under multiple management, the business or other entity is 
        deemed to constitute multiple facilities, one per management 
        entity, for purposes of this paragraph.
            ``(8) The term `monograph drug meeting' means any meeting 
        regarding the content of a proposed monograph drug order 
        request.
            ``(9) The term `monograph drug product' means a monograph 
        drug product that is marketed without an approved new drug 
        application in accordance with section 505G.
            ``(10) The term `monograph drug order request' means a 
        request for an order under section 505G for the issuance of an 
        administrative order for a change to the monograph drug 
        product.
            ``(11) The term `monograph drug requestor' means an entity 
        submitting a monograph drug order request or a monograph drug 
        meeting request or any other inquiry relating to a request for 
        an order or development of a monograph drug order request.
            ``(12) The term `person' includes an affiliate thereof.
            ``(13) The term `Tier 1 monograph drug order request' means 
        any monograph drug order request not determined to be a Tier 2 
        monograph drug order request.
            ``(14)(A) The term `Tier 2 monograph drug order request' 
        means, subject to subparagraph (B), a monograph drug order 
        request for--
                    ``(i) the reordering of existing information in the 
                drug facts label of a monograph drug product;
                    ``(ii) the addition of information to the other 
                information section of the drug facts label of a 
                nonprescription drug product, as limited by part 
                201.66(c)(7) of title 21, Code of Federal Regulations;
                    ``(iii) modification to the directions for use 
                section of the drug facts label of a nonprescription 
                drug product, if such changes conform to changes made 
                pursuant to section 505G(d);
                    ``(iv) the standardization of the concentration or 
                dose of a specific finalized ingredient within a 
                particular finalized monograph;
                    ``(v) a change to ingredient nomenclature to align 
                with nomenclature of a standards-setting organization; 
                or
                    ``(vi) addition of an interchangeable term in 
                accordance with part 330.1 of title 21, Code of Federal 
                Regulations (or any successor regulation).
            ``(B) The Secretary may, based on program implementation 
        experience or other factors found appropriate by the Secretary, 
        characterize any monograph drug order request as a Tier 2 
        monograph drug order request (including recategorizing a 
        request from Tier 1 to Tier 2) and publish such determination 
        in a proposed order issued pursuant to section 505G(c).

``SEC. 744L-1. AUTHORITY TO ASSESS AND USE MONOGRAPH DRUG FEES.

    ``(a) Types of Fees.--Beginning with fiscal year 2019, the 
Secretary shall assess and collect fees in accordance with this section 
as follows:
            ``(1) Facility fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that owns a facility 
                identified as a monograph drug facility on December 31 
                of the fiscal year or at any time during the preceding 
                12-month period shall be assessed an annual fee for 
                each such facility as determined under subsection (c).
                    ``(B) Exception.--
                            ``(i) In general.--A fee shall not be 
                        assessed under subparagraph (A) if the 
                        identified monograph drug facility has ceased 
                        all activities related to monograph drugs prior 
                        to the publication of the Notice under 
                        subparagraph C and has updated its registration 
                        to reflect such change under the requirements 
                        for drug establishment registration set forth 
                        in section 510.
                            ``(ii) Fee amount.--The amount of the fee 
                        for a contract manufacturing organization 
                        facility shall be equal to two-thirds the 
                        amount of the fee for a monograph drug facility 
                        that is not a contract manufacturing 
                        organization facility.
                    ``(C) Due date.--
                            ``(i) For first program year.--For fiscal 
                        year 2019, the facility fees required under 
                        subparagraph (A) shall be due 45 calendar days 
                        after publication of the Federal Register 
                        notice provided for under subsection (c)(4)(A).
                            ``(ii) Subsequent fiscal years.--For each 
                        fiscal year after fiscal year 2019, the 
                        facility fees required under subparagraph (A) 
                        shall be due on the later of--
                                    ``(I) the first business day of 
                                June of such year; or
                                    ``(II) the first business day after 
                                the date of enactment of an 
                                appropriations Act providing for the 
                                collection and obligation of fees under 
                                this section for such year.
            ``(2) Monograph drug order request fee.--
                    ``(A) In general.--Each person that submits a 
                monograph drug order request shall be subject to a fee 
                for a monograph drug order request. The monograph drug 
                order request fee under paragraph (2) shall be--
                            ``(i) for a Tier 1 monograph drug order 
                        request, $500,000, adjusted for inflation for 
                        the fiscal year (as determined under subsection 
                        (c)(1)); and
                            ``(ii) for a Tier 2 monograph drug order 
                        request other than a Tier 1 request, $100,000 
                        adjusted for inflation for the fiscal year (as 
                        determined under subsection (c)(1)).
                    ``(B) Due date.--The monograph drug order request 
                fees required under subparagraph (A) shall be due on 
                the date of submission of the monograph drug order 
                request.
                    ``(C) Exception for certain safety changes.--A 
                person who is named as the requestor in a monograph 
                drug order shall not be subject to a fee under 
                subparagraph (A) if the Secretary finds that the 
                monograph drug order request seeks to change the Drug 
                Facts labeling of a monograph drug product in a way 
                that would add to or strengthen--
                            ``(i) a contraindication, warning, or 
                        precaution;
                            ``(ii) a statement about risk associated 
                        with misuse or abuse; or
                            ``(iii) an instruction about dosage and 
                        administration that is intended to increase the 
                        safe use of the monograph drug product.
                    ``(D) Refund of fee if order request is 
                recategorized as a tier 2 monograph drug order 
                request.--If the Secretary determines that a monograph 
                drug request initially characterized as Tier 1 should 
                be re-characterized as a Tier 2 monograph drug order 
                request, and the requestor has paid a Tier 1 fee in 
                accordance with subparagraph (A)(i), the Secretary 
                shall refund the requestor the difference between the 
                Tier 1 and Tier 2 fees determined under subparagraphs 
                (A)(i) and (A)(ii), respectively.
                    ``(E) Refund of fee if order request refused for 
                filing or withdrawn before filing.--The Secretary shall 
                refund 75 percent of the fee paid under subparagraph 
                (B) for any order request that is refused for filing.
                    ``(F) Fees for order requests previously refused 
                for filing or withdrawn before filing.--A monograph 
                drug order request that was submitted but was refused 
                for filing, or was withdrawn before being accepted or 
                refused for filing, shall be subject to the full fee 
                under subparagraph (A) upon being resubmitted or filed 
                over protest.
                    ``(G) Refund of fee if order request withdrawn.--If 
                an order request is withdrawn after the order request 
                was filed, the Secretary may refund the fee or a 
                portion of the fee if no substantial work was performed 
                on the order request after the application was filed. 
                The Secretary shall have the sole discretion to refund 
                a fee or a portion of the fee under this subparagraph. 
                A determination by the Secretary concerning a refund 
                under this paragraph shall not be reviewable.
            ``(3) Refunds.--
                    ``(A) In general.--Other than refunds under 
                subparagraphs (D) through (G) of paragraph (2), the 
                Secretary shall not refund any fee paid under this 
                subsection, except as provided in subparagraph (B).
                    ``(B) Disputes concerning fees.--To qualify for the 
                return of a fee claimed to have been paid in error 
                under this paragraph, a person shall submit to the 
                Secretary a written request justifying such return 
                within 180 calendar days after such fee was paid.
    ``(b) Fee Revenue Amounts.--
            ``(1) Fiscal year 2019.--For fiscal year 2019, fees under 
        subsection (a)(1) shall be established to generate a total 
        facility fee revenue amount equal to the sum of--
                    ``(A) the annual base revenue for fiscal year 2019 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(2)); and
                    ``(C) additional direct cost adjustments (as 
                determined under subsection (c)(3)).
            ``(2) Subsequent fiscal years.--For each of the fiscal 
        years 2020 through 2023, fees under subsection (a)(1) shall be 
        established to generate a total facility fee revenue amount 
        equal to the sum of--
                    ``(A) the annual base revenue for the fiscal year 
                (as determined under paragraph (3));
                    ``(B) the dollar amount equal to the inflation 
                adjustment for the fiscal year (as determined under 
                subsection (c)(1));
                    ``(C) the dollar amount equal to the operating 
                reserve adjustment for the fiscal year, if applicable 
                (as determined under subsection (c)(2));
                    ``(D) additional direct cost adjustments (as 
                determined under subsection (c)(3)); and
                    ``(E) additional dollar amounts for each fiscal 
                year as follows:
                            ``(i) $7,000,000 for fiscal year 2020.
                            ``(ii) $6,000,000 for fiscal year 2021.
                            ``(iii) $7,000,000 for fiscal year 2022.
                            ``(iv) $3,000,000 for fiscal year 2023.
            ``(3) Annual base revenue.--For purposes of paragraphs 
        (1)(A) and (2)(A), the dollar amount of the annual base revenue 
        for a fiscal year shall be--
                    ``(A) for fiscal year 2019, $8,000,000; and
                    ``(B) for fiscal years 2020 through 2023, the 
                dollar amount of the total revenue amount established 
                under this subsection for the previous fiscal year, not 
                including any adjustments made under subsection (c)(2) 
                or (c)(3).
    ``(c) Adjustments; Annual Fee Setting.--
            ``(1) Inflation adjustment.--
                    ``(A) In general.--For purposes of subsection 
                (b)(2)(B), the dollar amount of the inflation 
                adjustment to the annual base revenue for fiscal year 
                2020 and each subsequent fiscal year shall be equal to 
                the product of--
                            ``(i) such annual base revenue for the 
                        fiscal year under subsection (b)(2); and
                            ``(ii) the inflation adjustment percentage 
                        under subparagraph (B).
                    ``(B) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this subparagraph 
                for a fiscal year is equal to--
                            ``(i) for each of fiscal years 2020 through 
                        2021, the average annual percent change that 
                        occurred in the Consumer Price Index for urban 
                        consumers (Washington-Baltimore, DC-MD-VA-WV; 
                        Not Seasonally Adjusted; All items; Annual 
                        Index) for the first 3 years of the preceding 4 
                        years of available data; and
                            ``(ii) for each of fiscal years 2022 and 
                        2023, the sum of--
                                    ``(I) the average annual percent 
                                change in the cost, per full-time 
                                equivalent position of the Food and 
                                Drug Administration, of all personnel 
                                compensation and benefits paid with 
                                respect to such positions for the first 
                                3 years of the preceding 4 fiscal 
                                years, multiplied by the proportion of 
                                personnel compensation and benefits 
                                costs to total costs of monograph drug 
                                activities (as defined in subsection 
                                (a)) for the first 3 years of the 
                                preceding 4 fiscal years; and
                                    ``(II) the average annual percent 
                                change that occurred in the Consumer 
                                Price Index for urban consumers 
                                (Washington-Baltimore, DC-MD-VA-WV; Not 
                                Seasonally Adjusted; All items; Annual 
                                Index) for the first 3 years of the 
                                preceding 4 years of available data 
                                multiplied by the proportion of all 
                                costs other than personnel compensation 
                                and benefits costs to total costs of 
                                monograph drug activities for the first 
                                3 years of the preceding 4 fiscal 
                                years.
            ``(2) Operating reserve adjustment.--
                    ``(A) For fiscal year 2019 and subsequent fiscal 
                years, the Secretary may, in addition to adjustments 
                under paragraphs (1) and (2), further increase the fee 
                revenue and fees if such an adjustment is necessary to 
                provide operating reserves of carryover user fees for 
                monograph drug activities for the number of weeks 
                specified in subparagraph (B).
                    ``(B) For each fiscal year the number of weeks of 
                operating reserves shall be no more than--
                            ``(i) 3 weeks for fiscal year 2019;
                            ``(ii) 7 weeks for fiscal year 2020;
                            ``(iii) 10 weeks for fiscal year 2021;
                            ``(iv) 10 weeks for fiscal year 2022; and
                            ``(v) 10 weeks for fiscal year 2023.
                    ``(C) If, for fiscal years 2020 through 2023, the 
                Secretary has carryover balances for monograph drug 
                activities in excess of the number of weeks of such 
                operating reserves specified in subparagraph B, the 
                Secretary shall reduce such fee revenue and fees to 
                provide for not more than the number of weeks of such 
                operating reserves specified in subparagraph (B)(v).
                    ``(D) If an adjustment under this paragraph is 
                made, the rationale for the amount of the increase or 
                decrease (as applicable) in fee revenue and fees shall 
                be contained in the annual Federal Register notice 
                under paragraph (5) establishing fee revenue and fees 
                for the fiscal year involved.
            ``(3) Additional direct cost adjustment.--The Secretary 
        shall, in addition to adjustments under paragraphs (1) and (2), 
        further increase the fee revenue by an amount equal to--
                    ``(A) 14,000,000 for fiscal year 2019;
                    ``(B) 7,000,000 for fiscal year 2020;
                    ``(C) 4,000,000 for fiscal year 2021;
                    ``(D) 3,000,000 for fiscal year 2022; and
                    ``(E) 3,000,000 for fiscal year 2023.
            ``(4) Annual fee setting.--
                    ``(A) Fiscal year 2019.--The Secretary shall, not 
                later than January 31, 2019--
                            ``(i) establish monograph drug facility 
                        fees for fiscal year 2019 under subsection 
                        (a)(1), based on the revenue amount for such 
                        year under subsection (b) and the adjustments 
                        provided under this subsection; and
                            ``(ii) publish such fee revenue and 
                        facility fees in the Federal Register.
                    ``(B) Subsequent fiscal years.--The Secretary 
                shall, not later than January 31 of each fiscal year 
                that begins after September 30, 2019, establish for 
                each such fiscal year, based on the revenue amounts 
                under subsection (b) and the adjustments provided under 
                this subsection--
                            ``(i) monograph drug facility fees under 
                        subsection (a)(1);
                            ``(ii) monograph drug order request fees 
                        under subsection (a)(2); and
                            ``(iii) publish such fee revenue, facility 
                        fees, and monograph drug order request fees in 
                        the Federal Register.
    ``(d) Identification of Facilities.--Each person that owns a 
monograph drug facility shall submit to the Secretary the information 
required under this subsection each year. Such information shall, for 
each fiscal year--
            ``(1) be submitted as part of the requirements for drug 
        establishment registration set forth in section 510; and
            ``(2) include for each such facility, at a minimum, 
        identification of the facility's business operation as that of 
        a monograph drug facility.
    ``(e) Effect of Failure To Pay Fees.--
            ``(1) In general.--A monograph drug order request submitted 
        by a person subject to fees under subsection (a) shall be 
        considered incomplete and shall not be accepted for filing by 
        the Secretary until all fees owed by such person have been 
        paid.
            ``(2) Effect on eligibility for meetings.--If a monograph 
        drug requestor fails to pay a fee assessed under subsection 
        (a), the requestor shall be considered ineligible for monograph 
        drug meetings.
    ``(f) Monograph Drug Facility Fee.--Failure to pay the fee under 
subsection (a)(1) within 20 calendar days of the due date as specified 
in subparagraph (D) of such subsection shall result in the Secretary 
placing the facility on a publicly available arrears list until such 
fee has been paid.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for monograph drug activities.
            ``(2) Collections and appropriation acts.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                fees authorized by this section shall be collected and 
                available in each fiscal year in an amount not to 
                exceed the amount specified in appropriation Acts, or 
                otherwise made available for obligation, for such 
                fiscal year.
                    ``(B) Use of fees and limitation.--The fees 
                authorized by this section shall be available to defray 
                increases in the costs of the resources allocated for 
                monograph drug activities (including increases in such 
                costs for an additional number of full-time equivalent 
                positions in the Department of Health and Human 
                Services to be engaged in such activities), only if the 
                Secretary allocates for such purpose an amount for such 
                fiscal year (excluding amounts from fees collecting 
                under this section) no less than $12,000,000, 
                multiplied by the adjustment factor applicable to the 
                fiscal year involved.
                    ``(C) Compliance.--The Secretary shall be 
                considered to have met the requirements of subparagraph 
                (B) in any fiscal year if the costs funded by 
                appropriations and allocated for the monograph drug 
                activities are not more than 15 percent below the level 
                specified in such subparagraph.
                    ``(D) Provision for early payments in subsequent 
                years.--Payment of fees authorized under this section 
                for a fiscal year (after fiscal year 2019), prior to 
                the due date for such fees, may be accepted by the 
                Secretary in accordance with authority provided in 
                advance in a prior year appropriations Act.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2019 through 2023, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total amount of fees assessed for such fiscal year under this 
        section.
    ``(h) Collection of Unpaid Fees.--In any case where the Secretary 
does not receive payment of a fee assessed under subsection (a) within 
30 calendar days after it is due, such fee shall be treated as a claim 
of the United States Government subject to subchapter II of chapter 37 
of title 31.
    ``(i) Construction.--This section may not be construed to require 
that the number of full-time equivalent positions in the Department of 
Health and Human Services, for officers, employers, and advisory 
committees not engaged in monograph drug activities, be reduced to 
offset the number of officers, employees, and advisory committees so 
engaged.

``SEC. 744L-2. REAUTHORIZATION; REPORTING REQUIREMENTS.

    ``(a) Performance Report.--Beginning with fiscal year 2019, and not 
later than 120 calendar days after the end of each fiscal year 
thereafter for which fees are collected under this part, the Secretary 
shall prepare and submit to the Committee on the Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report concerning the 
progress of the Food and Drug Administration in achieving the goals 
identified in the letters described in section 201 of the Over-the-
Counter Drug Safety, Innovation, and Reform Act during such fiscal year 
and the future plans of the Food and Drug Administration for meeting 
such goals.
    ``(b) Fiscal Report.--Not later than 120 calendar days after the 
end of fiscal year 2019 and each subsequent fiscal year for which fees 
are collected under this part, the Secretary shall prepare and submit 
to the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the House of 
Representatives a report on the implementation of the authority for 
such fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
    ``(c) Public Availability.--The Secretary shall make the reports 
required under subsections (a) and (b) available to the public on the 
internet website of the Food and Drug Administration.
    ``(d) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals described in 
        subsection (a), and plans for meeting the goals, for monograph 
        drug activities for the first 5 fiscal years after fiscal year 
        2023, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(B) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 calendar days for 
                the public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2023, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.''.
                                                       Calendar No. 413

115th CONGRESS

  2d Session

                                S. 2315

_______________________________________________________________________

                                 A BILL

   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
regulatory framework with respect to certain nonprescription drugs that 
 are marketed without an approved new drug application, and for other 
                               purposes.

_______________________________________________________________________

                              May 14, 2018

                       Reported with an amendment