[House Report 115-827]
[From the U.S. Government Publishing Office]


115th Congress    }                                          {   Report
                         HOUSE OF REPRESENTATIVES
 2d Session       }                                          {  115-827

======================================================================



 
 OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION, AND REFORM ACT OF 2018

                                _______
                                

 July 16, 2018.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Walden, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 5333]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 5333) 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, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................    22
Background and Need for Legislation..............................    23
Committee Action.................................................    23
Committee Votes..................................................    23
Oversight Findings and Recommendations...........................    25
New Budget Authority, Entitlement Authority, and Tax Expenditures    25
Congressional Budget Office Estimate.............................    25
Federal Mandates Statement.......................................    46
Statement of General Performance Goals and Objectives............    46
Duplication of Federal Programs..................................    46
Committee Cost Estimate..........................................    46
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......    47
Disclosure of Directed Rule Makings..............................    47
Advisory Committee Statement.....................................    47
Applicability to Legislative Branch..............................    47
Section-by-Section Analysis of the Legislation...................    47
Changes in Existing Law Made by the Bill, as Reported............    53
Additional Views.................................................    94

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018''.

                        TITLE I--OTC DRUG REVIEW

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

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

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

  ``(a) Nonprescription Drugs Marketed Without an Approved 
Application.--Nonprescription drugs marketed without an approved new 
drug application under section 505, as of the date of the enactment of 
the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 
2018, shall be treated in accordance with this subsection.
          ``(1) Drugs subject to a final monograph; category i drugs 
        subject to a tentative final monograph.--A drug is deemed to be 
        generally recognized as safe and effective within the meaning 
        of section 201(p)(1), not a new drug under section 201(p), and 
        not subject to section 503(b)(1), if--
                  ``(A) the drug is--
                          ``(i) in conformity with the requirements for 
                        nonprescription use of a final monograph issued 
                        under part 330 of title 21, Code of Federal 
                        Regulations (except as provided in paragraph 
                        (2)), the general requirements for 
                        nonprescription drugs, and requirements under 
                        subsections (b), (c), and (k); and
                          ``(ii) except as permitted by an order issued 
                        under subsection (b) or, in the case of a minor 
                        change in the drug, in conformity with an order 
                        issued under subsection (c), in a dosage form 
                        that, immediately prior to the date of the 
                        enactment of this section, has been used to a 
                        material extent and for a material time within 
                        the meaning of section 201(p)(2); or
                  ``(B) the drug is--
                          ``(i) classified in category I for safety and 
                        effectiveness under a tentative final monograph 
                        that is the most recently applicable proposal 
                        or determination issued under part 330 of title 
                        21, Code of Federal Regulations;
                          ``(ii) in conformity with the proposed 
                        requirements for nonprescription use of such 
                        tentative final monograph, any applicable 
                        subsequent determination by the Secretary, the 
                        general requirements for nonprescription drugs, 
                        and requirements under subsections (b), (c), 
                        and (k); and
                          ``(iii) except as permitted by an order 
                        issued under subsection (b) or, in the case of 
                        a minor change in the drug, in conformity with 
                        an order issued under subsection (c), in a 
                        dosage form that, immediately prior to the date 
                        of the enactment of this section, has been used 
                        to a material extent and for a material time 
                        within the meaning of section 201(p)(2).
          ``(2) Treatment of sunscreen drugs.--With respect to 
        sunscreen drugs subject to this section, the applicable 
        requirements shall be the requirements specified in part 352 of 
        title 21, Code of Federal Regulations, as published on May 21, 
        1999, beginning on page 27687 of volume 64 of the Federal 
        Register, except that the applicable requirements governing 
        effectiveness and labeling shall be those specified in section 
        201.327 of title 21, Code of Federal Regulations, subject to 
        the requirements of subsections (b), (c), and (k).
          ``(3) Category iii drugs subject to a tentative final 
        monograph; category i drugs subject to proposed monograph or 
        advance notice of proposed rulemaking.--A drug that is not 
        described in paragraphs (1), (2), or (4) is not required to be 
        the subject of an application approved under section 505, and 
        is not subject to section 503(b)(1), if--
                  ``(A) the drug is--
                          ``(i) classified in category III for safety 
                        or effectiveness in the preamble of a proposed 
                        rule establishing a tentative final monograph 
                        that is the most recently applicable proposal 
                        or determination for such drug issued under 
                        part 330 of title 21, Code of Federal 
                        Regulations;
                          ``(ii) in conformity with--
                                  ``(I) the conditions of use, 
                                including indication and dosage 
                                strength, if any, described for such 
                                category III drug in such preamble or 
                                in an applicable subsequent proposed 
                                rule;
                                  ``(II) the proposed requirements for 
                                drugs classified in such tentative 
                                final monograph in category I in the 
                                most recently proposed rule 
                                establishing requirements related to 
                                such tentative final monograph and in 
                                any final rule establishing 
                                requirements that are applicable to the 
                                drug; and
                                  ``(III) the general requirements for 
                                nonprescription drugs and requirements 
                                under subsections (b) or (k); and
                          ``(iii) in a dosage form that, immediately 
                        prior to the date of the enactment of this 
                        section, was not required to have satisfied the 
                        requirements of section 330.14 of title 21, 
                        Code of Federal Regulations (as in effect at 
                        that time), in order for such drug to be 
                        lawfully marketed without an application 
                        approved under section 505; or
                  ``(B) the drug is--
                          ``(i) classified in category I for safety and 
                        effectiveness under a proposed monograph or 
                        advance notice of proposed rulemaking that is 
                        the most recently applicable proposal or 
                        determination for such drug issued under part 
                        330 of title 21, Code of Federal Regulations;
                          ``(ii) in conformity with the requirements 
                        for nonprescription use of such proposed 
                        monograph or advance notice of proposed 
                        rulemaking, any applicable subsequent 
                        determination by the Secretary, the general 
                        requirements for nonprescription drugs, and 
                        requirements under subsections (b) or (k); and
                          ``(iii) in a dosage form that, immediately 
                        prior to the date of the enactment of this 
                        section, has been used to a material extent and 
                        for a material time within the meaning of 
                        section 201(p)(2).
          ``(4) Category ii drugs deemed new drugs.--A drug that is 
        classified in category II for safety or effectiveness under a 
        tentative final monograph or that is subject to a determination 
        to be not safe or effective in a proposed rule that is the most 
        recently applicable proposal issued under part 330 of title 21, 
        Code of Federal Regulations, shall be deemed to be a new drug 
        within the meaning of section 201(p), misbranded under section 
        502(ee), and subject to the requirement for an approved new 
        drug application under section 505 beginning on the day that is 
        180 calendar days after the date of the enactment of this 
        section, unless, before such day, the Secretary determines that 
        it is in the interest of public health to extend the period 
        during which the drug may be marketed without such an approved 
        new drug application.
          ``(5) Drugs not grase deemed new drugs.--A drug that the 
        Secretary has determined not to be generally recognized as safe 
        and effective within the meaning of section 201(p)(1) under a 
        final determination issued under part 330 of title 21, Code of 
        Federal Regulations, shall be deemed to be a new drug within 
        the meaning of section 201(p), misbranded under section 
        502(ee), and subject to the requirement for an approved new 
        drug application under section 505.
          ``(6) Other drugs deemed new drugs.--Except as provided in 
        subsection (m), a drug is deemed to be a new drug within the 
        meaning of section 201(p) and misbranded under section 502(ee) 
        if the drug--
                  ``(A) is not subject to section 503(b)(1); and
                  ``(B) is not described in paragraphs (1), (2), (3), 
                (4), or (5), or subsection (b)(1)(B).
  ``(b) Administrative Orders.--
          ``(1) In general.--
                  ``(A) Determination.--The Secretary may, on the 
                initiative of the Secretary or at the request of one or 
                more requestors, issue administrative orders 
                determining whether there are conditions under which 
                specific drugs, classes of such drugs, or combinations 
                of such drugs are determined to be--
                          ``(i) not subject to section 503(b)(1); and
                          ``(ii) generally recognized as safe and 
                        effective within the meaning of section 
                        201(p)(1).
                  ``(B) Effect.--A drug or combination of drugs shall 
                be deemed to not require approval under section 505 if 
                such drug or combination of drugs--
                          ``(i) is determined by the Secretary to meet 
                        the conditions specified in clauses (i) and 
                        (ii) of subparagraph (A);
                          ``(ii) is marketed in conformity with an 
                        administrative order under this subsection;
                          ``(iii) meets the general requirements for 
                        nonprescription drugs; and
                          ``(iv) meets the requirements under 
                        subsections (c) and (k).
                  ``(C) Standard.--The Secretary shall find that a drug 
                is not generally recognized as safe and effective 
                within the meaning of section 201(p)(1) if--
                          ``(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.--
                  ``(A) In general.--In issuing an administrative order 
                under paragraph (1) upon the Secretary's initiative, 
                the Secretary shall--
                          ``(i) make reasonable efforts to notify 
                        informally, not later than 2 business days 
                        before the issuance of the proposed order, the 
                        sponsors of drugs who have a listing in effect 
                        under section 510(j) for the drugs or 
                        combination of drugs that will be subject to 
                        the administrative order;
                          ``(ii) after any such reasonable efforts of 
                        notification--
                                  ``(I) issue a proposed administrative 
                                order by publishing it on the website 
                                of the Food and Drug Administration and 
                                include in such order the reasons for 
                                the issuance of such order; and
                                  ``(II) publish a 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 completion of the 
                        proceedings specified in 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, which order shall 
                                not take effect until the time for 
                                requesting judicial review under 
                                paragraph (3)(D)(ii) has expired;
                                  ``(II) publish a notice of such final 
                                administrative order in the Federal 
                                Register;
                                  ``(III) afford requestors of drugs 
                                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 must 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 
                                persons which sought such dispute 
                                resolution of their right to request a 
                                hearing.
                  ``(B) Exceptions.--When issuing an administrative 
                order under paragraph (1) on the Secretary's initiative 
                proposing to determine that a drug described in 
                subsection (a)(3) 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 no 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 
                        interests 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).
          ``(3) Hearings; judicial review.--
                  ``(A) In general.--Only a person who participated in 
                each stage of formal dispute resolution under subclause 
                (III) of paragraph (2)(A)(iv) of an administrative 
                order with respect to a drug may request a hearing 
                concerning a final administrative order issued under 
                such paragraph with respect to such drug. Such person 
                must submit a request for a hearing, which shall be 
                based solely on 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.--
                          ``(i) In general.--The Secretary shall not be 
                        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 
                                (a)(3)(A); and
                                  ``(II) with respect to which no human 
                                or non-human data studies 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.
                          ``(ii) Human data studies and non-human data 
                        defined.--In this subparagraph:
                                  ``(I) The term `human data studies' 
                                means clinical trials of safety or 
                                effectiveness (including actual use 
                                studies), pharmacokinetics studies, or 
                                bioavailability studies.
                                  ``(II) The term `non-human data' 
                                means data from testing other than with 
                                human subjects which provides 
                                information concerning safety or 
                                effectiveness.
                  ``(C) Hearing procedures.--
                          ``(i) Denial of request for hearing.--If the 
                        Secretary determines that information submitted 
                        in a request for a hearing under subparagraph 
                        (A) with respect to a final administrative 
                        order issued under paragraph (2)(A)(iv), does 
                        not identify 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 presiding 
                        officer of a hearing requested under 
                        subparagraph (A) shall--
                                  ``(I) be designated by the Secretary;
                                  ``(II) not be an employee of the 
                                Center for Drug Evaluation and 
                                Research; and
                                  ``(III) not have been previously 
                                involved in the development of the 
                                administrative order involved or 
                                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.--
                                  ``(I) 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.
                                  ``(II) 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) Period 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 such 
                        request for judicial 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 a hearing 
                                with respect to such order is denied 
                                under subparagraph (B) or (C)(i);
                                  ``(III) the date on which a final 
                                decision is made following a hearing 
                                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 drug, 
                        class of drugs, or combination of drugs subject 
                        to this section poses an imminent hazard to the 
                        public health, the Secretary, after first 
                        making reasonable efforts to notify, not later 
                        than 48 hours before issuance of such order 
                        under this subparagraph, sponsors who have a 
                        listing in effect under section 510(j) for such 
                        drug or combination of drugs--
                                  ``(I) may issue an interim final 
                                administrative order for such drug, 
                                class of drugs, or combination of drugs 
                                under paragraph (1), together with a 
                                detailed statement of the reasons for 
                                such order;
                                  ``(II) shall publish in the Federal 
                                Register a notice of availability of 
                                any such order; and
                                  ``(III) shall provide for a public 
                                comment period of at least 45 calendar 
                                days with respect to 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) make reasonable efforts to 
                                notify informally, not later than 48 
                                hours before the issuance of the 
                                interim final order, the sponsors of 
                                drugs who have a listing in effect 
                                under section 510(j) for such drug or 
                                combination of drugs;
                                  ``(II) after reasonable efforts of 
                                notification, 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;
                                  ``(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 
                                with respect to 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 such 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 must 
                        initially 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.--A sponsor of a drug subject to a 
                final order issued under subparagraph (D) and that 
                participated in each stage of formal dispute resolution 
                under clause (iii) of such subparagraph may request a 
                hearing on such order. The provisions of subparagraphs 
                (A), (B), and (C) of paragraph (3), other than 
                paragraph (3)(C)(v)(II), 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).
                  ``(F) Timing.--
                          ``(i) Final order and hearing.--The Secretary 
                        shall--
                                  ``(I) not later than 6 months after 
                                the date on which the comment period 
                                closes under subparagraph (A) or (B), 
                                issue a final order in accordance with 
                                paragraph (1); and
                                  ``(II) not later than 12 months after 
                                the date on which such final order is 
                                issued, complete any hearing under 
                                subparagraph (E).
                          ``(ii) Dispute resolution request.--The 
                        Secretary shall specify in an interim final 
                        order issued under subparagraph (A) or (B) such 
                        shorter periods for requesting dispute 
                        resolution under subparagraph (D)(iii) as are 
                        necessary to meet the requirements of this 
                        subparagraph.
                  ``(G) Judicial review.--A final order issued pursuant 
                to subparagraph (F) shall be subject to judicial review 
                in accordance with paragraph (3)(D).
          ``(5) Administrative order initiated at the request of a 
        requestor.--
                  ``(A) In general.--In issuing an administrative order 
                under paragraph (1) at the request of a requestor 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) 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 paragraph (6), 
                        if the Secretary determines that a request does 
                        not meet the requirements for filing or is not 
                        sufficiently complete and formatted to permit a 
                        substantive review, the requestor may demand 
                        that the request be filed 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 under paragraph (1) 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 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, absent such a 
                                changed condition of use, such drug 
                                is--
                                          ``(aa) generally recognized 
                                        as safe and effective within 
                                        the meaning of section 
                                        201(p)(1) in accordance with 
                                        subsection (a)(1), (a)(2), or 
                                        an order under this subsection; 
                                        or
                                          ``(bb) subject to subsection 
                                        (a)(3), 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).
                          ``(ii) Exception.--The Secretary is not 
                        required to complete review of a request for a 
                        change described in clause (i)(II) if the 
                        Secretary determines that there is an 
                        inadequate basis to find the drug is generally 
                        recognized as safe and effective within the 
                        meaning of section 201(p)(1) under paragraph 
                        (1) and issues a final order announcing that 
                        determination.
                          ``(iii) Withdrawal.--The requestor may 
                        withdraw a request under this paragraph, 
                        according to the procedures set forth pursuant 
                        to subsection (d)(2)(B). Notwithstanding any 
                        other provision of this section, if such 
                        request is withdrawn, the Secretary may cease 
                        proceedings under this subparagraph.
                  ``(C) Exclusivity.--
                          ``(i) In general.--A final administrative 
                        order issued in response to a request under 
                        this section 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), for a period of 18 months 
                        following the effective date of such final 
                        order, to market drugs--
                                  ``(I) incorporating changes described 
                                in clause (ii);
                                  ``(II) beginning on the date the 
                                requestor (or any such licensees, 
                                assignees, or successors in interest) 
                                may lawfully market such drugs pursuant 
                                to the order; and
                                  ``(III) 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 subsection (a)(1), 
                                (a)(2), or (a)(3);
                                  ``(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 
                                (m)(1), other than drugs subject to an 
                                active enforcement action under chapter 
                                III of this Act.
                          ``(iv) Limitations on exclusivity.--
                                  ``(I) In general.--Only one period of 
                                exclusivity shall be granted, under 
                                each order described in clause (i), 
                                with respect to changes (to the drug 
                                subject to such order) which are 
                                either--
                                          ``(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) No exclusivity allowed.--No 
                                exclusivity shall apply to changes to a 
                                drug which are--
                                          ``(aa) the subject of a Tier 
                                        2 OTC monograph order request 
                                        (as defined in section 744N);
                                          ``(bb) safety-related 
                                        changes, as defined by the 
                                        Secretary, or any other changes 
                                        the Secretary considers 
                                        necessary to assure safe use; 
                                        or
                                          ``(cc) changes related to 
                                        methods of testing safety or 
                                        efficacy.
                          ``(v) New human data studies defined.--In 
                        this subparagraph, the term `new human data 
                        studies' means clinical trials of safety or 
                        effectiveness (including actual use studies), 
                        pharmacokinetics studies, or bioavailability 
                        studies, the results of which--
                                  ``(I) have not been relied on by the 
                                Secretary 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 
                                        that was approved under section 
                                        505; and
                                  ``(II) do not duplicate the results 
                                of another study that was relied on by 
                                the Secretary 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 
                                        that was approved under section 
                                        505.
                          ``(vi) Effective date.--A final order subject 
                        to clause (i) shall take effect on the date 
                        when the order requestor (or the licensees, 
                        assignees, or successors in interest of such 
                        requestor with respect to such order) submits 
                        updated drug listing information under 
                        subsection (e) with respect to the change which 
                        is permitted under such order.
                          ``(vii) GAO study.--Not later than 4 years 
                        after the date of enactment of the Over-the-
                        Counter Monograph, Safety, Innovation, and 
                        Reform Act of 2018, the Comptroller General of 
                        the United States shall submit a study to the 
                        Committee on Energy and Commerce of the House 
                        of Representatives and the Committee on Health, 
                        Education, Labor, and Pensions of the Senate 
                        addressing the effectiveness and overall impact 
                        of exclusivity under this section, including 
                        its impact on consumer access. Such study shall 
                        include--
                                  ``(I) the number of nonprescription 
                                drug products that were granted 
                                exclusivity and the indication for 
                                which the nonprescription drug products 
                                were determined to be generally 
                                recognized as safe and effective;
                                  ``(II) whether the exclusivity for 
                                such drug products was granted for--
                                          ``(aa) a new active 
                                        ingredient (including any ester 
                                        or salt of the active 
                                        ingredient); or
                                          ``(bb) changes in the 
                                        conditions of use of a drug, 
                                        for which new human data 
                                        studies conducted or sponsored 
                                        by the requestor were 
                                        essential;
                                  ``(III) whether, and to what extent, 
                                the exclusivity impacted the 
                                requestor's or sponsor's decision to 
                                develop the drug product;
                                  ``(IV) an analysis of the 
                                implementation of the exclusivity 
                                provision in this subparagraph, 
                                including--
                                          ``(aa) the resources used by 
                                        the Food and Drug 
                                        Administration;
                                          ``(bb) the impact of such 
                                        provision on innovation, as 
                                        well as research and 
                                        development in the 
                                        nonprescription drug market;
                                          ``(cc) the impact of such 
                                        provision on competition in the 
                                        nonprescription drug market;
                                          ``(dd) the impact of such 
                                        provision on consumer access to 
                                        nonprescription drug products;
                                          ``(ee) the impact of such 
                                        provision on the prices of 
                                        nonprescription drug products; 
                                        and
                                          ``(ff) whether the 
                                        administrative orders initiated 
                                        by requestors under this 
                                        section have been sufficient to 
                                        encourage the development of 
                                        nonprescription drug products 
                                        that would likely not be 
                                        otherwise developed, or 
                                        developed in as timely a 
                                        manner; and
                                  ``(V) whether the administrative 
                                orders initiated by requestors under 
                                this section have been sufficient 
                                incentive to encourage innovation in 
                                the nonprescription drug market.
          ``(6) Information regarding safe nonprescription marketing 
        and use as condition for filing a generally recognized as safe 
        and effective request.--
                  ``(A) In general.--In response to a request under 
                this section that a drug described in subparagraph (B) 
                be generally recognized as safe and effective, the 
                Secretary--
                          ``(i) may file such request, if the request 
                        includes information specified under 
                        subparagraph (C) with respect to safe 
                        nonprescription marketing and use of such drug; 
                        or
                          ``(ii) if the request fails to include 
                        information specified under subparagraph (C), 
                        shall refuse to file such request and require 
                        that nonprescription marketing of the drug be 
                        pursuant to a new drug application as described 
                        in subparagraph (D).
                  ``(B) Drug described.--A drug described in this 
                subparagraph is a nonprescription drug which contains 
                an active ingredient not previously incorporated in a 
                drug--
                          ``(i) specified in subsection (a)(1), (a)(2), 
                        or (a)(3);
                          ``(ii) subject to a final order under this 
                        section; or
                          ``(iii) subject to a final sunscreen order 
                        (as defined in section 586(2)(A)).
                  ``(C) Information demonstrating prima facie safe 
                nonprescription marketing and use.--Information 
                specified in this subparagraph, with respect to a 
                request described in subparagraph (A)(i), is--
                          ``(i) information sufficient for a prima 
                        facie 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 prima facie demonstration that the drug 
                        was marketed and safely used under comparable 
                        conditions of marketing and use in a country 
                        listed in section 802(b)(1)(A) or designated by 
                        the Secretary in accordance with section 
                        802(b)(1)(B)--
                                  ``(I) for such period of time as 
                                needed to provide reasonable assurances 
                                concerning the safe nonprescription use 
                                of the drug; and
                                  ``(II) during such time was subject 
                                to sufficient monitoring by a 
                                regulatory body considered acceptable 
                                by the Secretary for such monitoring 
                                purposes, including for adverse events 
                                associated with nonprescription use of 
                                the drug; or
                          ``(iii) if the Secretary determines that 
                        information described in clauses (i) or (ii) is 
                        not needed to provide a prima facie 
                        demonstration that the drug can be safely 
                        marketed and used as a nonprescription drug, 
                        such other information the Secretary determines 
                        is sufficient for such purposes.
                  ``(D) Marketing pursuant to new drug application.--In 
                the case of a request described in subparagraph 
                (A)(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 conditions specified in the 
                        request, for such period of time as the 
                        Secretary determines appropriate (not to exceed 
                        five consecutive years) pursuant to an 
                        application approved under section 505; and
                          ``(ii) during such time period, one million 
                        retail packages of the drug, or an equivalent 
                        quantity as determined by the Secretary, were 
                        distributed for retail sale, as determined in 
                        such manner as the Secretary finds appropriate.
                  ``(E) Rule of application.--Except in the case of a 
                request involving a drug described in section 586(9), 
                as in effect on January 1, 2017, if the Secretary 
                refuses to file a request under this paragraph, the 
                requestor may not file such request over protest under 
                paragraph (5)(A)(iii).
          ``(7) Packaging.--An administrative order issued under 
        paragraph (2), (4)(A), or (5) may include requirements for the 
        packaging of a drug to encourage use in accordance with 
        labeling. Such requirements may include unit dose packaging, 
        requirements for products intended for use by children, 
        requirements to reduce risk of harm from unsupervised 
        ingestion, and other appropriate requirements. This paragraph 
        does not authorize the Food and Drug Administration to require 
        standards or testing procedures as described in part 1700 of 
        title 16, Code of Federal Regulations.
          ``(8) Final and tentative final monographs for category i 
        drugs deemed final administrative orders.--
                  ``(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 is described in this subparagraph if it--
                          ``(i) establishes conditions of use for a 
                        drug described in paragraph (1) or (2) of 
                        subsection (a); and
                          ``(ii) represents the most recently 
                        promulgated version of such conditions, 
                        including as modified, in whole or in part, by 
                        any proposed or final rule.
                  ``(C) Deemed orders include harmonizing technical 
                amendments.--The deemed establishment of a final 
                administrative order under subparagraph (A) shall be 
                construed to include any technical amendments to such 
                order as the Secretary determines necessary to ensure 
                that such order is appropriately harmonized, in terms 
                of terminology or cross-references, with the applicable 
                provisions of this Act (and regulations thereunder) and 
                any other orders issued under this section.
  ``(c) Procedure for Minor Changes.--
          ``(1) In general.--Minor changes in the dosage form of a drug 
        that is described in paragraph (1) or (2) of subsection (a) or 
        the subject of an order issued under subsection (b) may be made 
        by a requestor without the issuance of an order under 
        subsection (b) if--
                  ``(A) the requestor maintains such information as is 
                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; and
                  ``(B) 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.--A sponsor shall submit 
                records requested by the Secretary relating to such a 
                minor change under section 704(a)(4), within 15 
                business days of receiving such a 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 sponsor of the drug 
                        in writing; and
                          ``(ii) provide the sponsor of the drug with a 
                        reasonable opportunity to provide additional 
                        information.
                  ``(C) Failure to submit sufficient information.--If 
                the sponsor 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 a change will affect safety or 
        effectiveness.--
                  ``(A) In general.--The Secretary shall issue one or 
                more administrative orders specifying requirements for 
                determining whether a minor change made by a sponsor 
                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.--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 drugs, 
                and may take into account the special needs of 
                populations, including children.
  ``(d) Confidentiality of Information Submitted to the Secretary.--
          ``(1) In general.--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 order under this section (including any minor 
        change under subsection (c)) 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.--
                  ``(A) In general.--Except as provided in subparagraph 
                (B), the Secretary shall--
                          ``(i) make any information submitted by a 
                        requestor in support of a request under 
                        subsection (b)(5)(A) available to the public 
                        not later than the date on which the proposed 
                        order is issued; and
                          ``(ii) make any information submitted by any 
                        other person with respect to an order requested 
                        (or initiated by the Secretary) under 
                        subsection (b), available to the public upon 
                        such submission.
                  ``(B) Limitations on public availability.--
                Information described in subparagraph (A) shall not be 
                made public if--
                          ``(i) the information pertains to 
                        pharmaceutical quality information, 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);
                          ``(ii) the information is submitted in a 
                        requestor-initiated request, but the requestor 
                        withdraws such request, in accordance with 
                        withdrawal procedures established by the 
                        Secretary, before the Secretary issues the 
                        proposed order;
                          ``(iii) the Secretary requests and obtains 
                        the information under subsection (c) and such 
                        information is not submitted in relation to an 
                        order under subsection (b); or
                          ``(iv) the information is of the type 
                        contained in raw datasets.
  ``(e) 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 section 510(j) 
within 30 calendar days of the date when the drug is first commercially 
marketed, except that a sponsor who was the order requestor with 
respect to an order subject to subsection (b)(5)(C) (or a licensee, 
assignee, or successor in interest of such requestor) shall submit 
updated drug listing information on or before the date when the drug is 
first commercially marketed.
  ``(f) Approvals Under Section 505.--The provisions of this section 
shall not be construed to preclude a person from seeking or maintaining 
the approval of a drug under sections 505(b)(1), 505(b)(2), and 505(j). 
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 that the drug is safe and effective 
that may be relied upon for purposes of an application under section 
505(b)(2), so that the applicant shall be required to submit for 
purposes of such application only information needed to support any 
modification of the drug that is not covered by such determination 
under this section.
  ``(g) Public Availability of Administrative Orders.--The Secretary 
shall establish, maintain, update (as determined necessary by the 
Secretary but no less frequently than annually), and make publicly 
available, with respect to orders issued under this section--
          ``(1) a repository of each final order and interim final 
        order in effect, including the complete text of the order; and
          ``(2) a listing of all orders proposed and under development 
        under subsection (b)(2), including--
                  ``(A) a brief description of each such order; and
                  ``(B) the Secretary's expectations, if resources 
                permit, for issuance of proposed orders over a three-
                year period.
  ``(h) Development Advice to Sponsors or Requestors.--The Secretary 
shall establish procedures under which sponsors or requestors may meet 
with appropriate officials of the Food and Drug Administration to 
obtain advice on the studies and other information necessary to support 
submissions under this section and other matters relevant to the 
regulation of nonprescription drugs and the development of new 
nonprescription drugs under this section.
  ``(i) Participation of Multiple Sponsors or Requestors.--The 
Secretary shall establish procedures to facilitate efficient 
participation by multiple sponsors or requestors in proceedings under 
this section, including provision for joint meetings with multiple 
sponsors or requestors or with organizations nominated by sponsors or 
requestors to represent their interests in a proceeding.
  ``(j) Electronic Format.--All submissions under this section shall be 
in electronic format.
  ``(k) 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) The provisions of section 310.545 of title 21, 
                Code of Federal Regulations, as in effect on the day 
                before the date of the enactment of this section, shall 
                be deemed to be a final order under subsection (b).
                  ``(B) Regulations in effect on the day before the 
                date of the enactment of this section, establishing 
                requirements for specific nonprescription drugs 
                marketed pursuant to this section (including such 
                requirements in parts 201 and 250 of title 21, Code of 
                Federal Regulations), shall be deemed to be final 
                orders under subsection (b), only as they apply to 
                drugs--
                          ``(i) subject to paragraph (1), (2), (3), or 
                        (4) of subsection (a); or
                          ``(ii) otherwise subject to an order under 
                        this section.
          ``(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 the 
        enactment of this section), or make technical changes to such 
        regulations to ensure conformity with appropriate terminology 
        and cross references. Notwithstanding subchapter II of chapter 
        5 of title 5, United States Code, any such withdrawal or 
        technical changes shall be made without public notice and 
        comment and shall be effective upon publication through notice 
        in the Federal Register (or upon such date as specified in such 
        notice).
  ``(l) Guidance.--The Secretary shall issue guidance that specifies--
          ``(1) the procedures and principles for formal meetings 
        between the Secretary and sponsors or requestors for drugs 
        subject to this section;
          ``(2) the format and content of data submissions to the 
        Secretary under this section;
          ``(3) the format of electronic submissions to the Secretary 
        under this section;
          ``(4) consolidated proceedings and the procedures for such 
        proceedings where appropriate; and
          ``(5) for minor changes in drugs, recommendations on how to 
        comply with the requirements in orders issued under subsection 
        (c)(3).
  ``(m) Rule of Construction.--
          ``(1) In general.--This section shall not affect the 
        treatment or status of a nonprescription drug--
                  ``(A) that is marketed without an application 
                approved under section 505 as of the date of the 
                enactment of this section;
                  ``(B) that is not subject to an order issued under 
                this section; and
                  ``(C) to which paragraphs (1), (2), (3), (4), or (5) 
                of subsection (a) do not apply.
          ``(2) Treatment of products previously found to be subject to 
        time and extent requirements.--
                  ``(A) Notwithstanding subsection (a), a drug 
                described in subparagraph (B) may only be lawfully 
                marketed, without an application approved under section 
                505, pursuant to an order issued under this section.
                  ``(B) A drug described in this subparagraph is a drug 
                which, prior to the date of the enactment of this 
                section, the Secretary had determined in a proposed or 
                final rule to be ineligible for review under the OTC 
                drug review (as such phrase `OTC drug review' was used 
                in section 330.14 of title 21, Code of Federal 
                Regulations, as in effect on the day before the date of 
                the enactment of this section).
          ``(3) Preservation of authority.--
                  ``(A) Nothing in paragraph (1) shall be construed to 
                preclude or limit the applicability of any other 
                provision of this Act.
                  ``(B) Nothing in subsection (a) 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 within the meaning of section 
                201(p)(1), as the Secretary determines appropriate.
  ``(n) Investigational New Drugs.--A drug is not subject to this 
section if an exemption for investigational use under section 505(i) is 
in effect for such drug.
  ``(o) Inapplicability of Paperwork Reduction Act.--Chapter 35 of 
title 44, United States Code, shall not apply to collections of 
information made under this section.
  ``(p) Inapplicability of Notice and Comment Rulemaking and Other 
Requirements.--The requirements of subsection (b) shall apply with 
respect to orders issued under this section instead of the requirements 
of subchapter II of chapter 5 of title 5, United States Code.
  ``(q) Definitions.--In this section:
          ``(1) The term `nonprescription drug' refers to a drug not 
        subject to the requirements of section 503(b)(1).
          ``(2) The term `sponsor' refers to any person marketing, 
        manufacturing, or processing a drug that--
                  ``(A) is listed pursuant to section 510(j); and
                  ``(B) is or will be subject to an administrative 
                order of the Food and Drug Administration.
          ``(3) The term `requestor' refers to any person or group of 
        persons marketing, manufacturing, processing, or developing a 
        drug.''.

SEC. 102. MISBRANDING.

  Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352) is amended by adding at the end the following:
  ``(ee) If it is a nonprescription drug that is subject to section 
505G, 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 and it was manufactured, prepared, propagated, 
compounded, or processed in a facility for which fees have not been 
paid as required by section 744O.''.

SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE-COUNTER DRUG 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 other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT.

  (a) Review of Nonprescription Sunscreen Active Ingredients.--
          (1) Applicability of section 505g for pending submissions.--
                  (A) In general.--A sponsor of a nonprescription 
                sunscreen active ingredient or combination of 
                nonprescription sunscreen active ingredients that, as 
                of the date of enactment of this Act, is subject to a 
                proposed sunscreen order under section 586C of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
                3) may elect, by means of giving written notification 
                to the Secretary of Health and Human Services within 
                180 calendar days of the enactment of this Act, to 
                transition into the review of such ingredient or 
                combination of ingredients pursuant to the process set 
                out in section 505G of the Federal Food, Drug, and 
                Cosmetic Act, as added by section 101 of this Act.
                  (B) Election exercised.--Upon receipt by the 
                Secretary of Health and Human Services of a timely 
                notification under subparagraph (A)--
                          (i) the proposed sunscreen order involved is 
                        deemed to be a request for an order under 
                        subsection (b) of section 505G of the Federal 
                        Food, Drug, and Cosmetic Act, as added by 
                        section 101 of this Act; and
                          (ii) such order is deemed to have been 
                        accepted for filing under subsection 
                        (b)(6)(A)(i) of such section 505G.
                  (C) Election not exercised.--A sponsor of a 
                nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients described in subparagraph (A) that does not 
                elect for such ingredient or combination of ingredients 
                to be reviewed under section 505G of the Federal Food, 
                Drug, and Cosmetic Act, as added by section 101 of this 
                Act, shall continue to have such ingredient or 
                combination of ingredients reviewed in accordance with 
                section 586C of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360fff-3) and may not subsequently elect 
                to transition into the review of such ingredient or 
                combination of ingredients pursuant to the process set 
                out in section 505G of such Act, as added by section 
                101 of this Act.
          (2) Definitions.--In this subsection, the terms ``sponsor'', 
        ``nonprescription'', ``sunscreen active ingredient'', and 
        ``proposed sunscreen order'' have the meanings given to those 
        terms in section 586 of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360fff).
  (b) Amendments to Sunscreen Provisions.--
          (1) Final sunscreen orders.--Paragraph (3) of section 586C(e) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-
        3(e)) is amended to read as follows:
          ``(3) Relationship to orders under section 505g.--A final 
        sunscreen order shall be deemed to be a final order under 
        section 505G.''.
          (2) Meetings.--Paragraph (7) of section 586C(b) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is 
        amended--
                  (A) by striking ``A sponsor may request'' and 
                inserting the following:
                  ``(A) In general.--A sponsor may request''; and
                  (B) by adding at the end the following:
                  ``(B) Confidential meetings.--A sponsor may request 
                one or more confidential meetings with respect to a 
                proposed sunscreen order, including a letter deemed to 
                be a proposed sunscreen order under paragraph (3), to 
                discuss matters involving confidential commercial 
                information or trade secrets. The Secretary shall 
                convene a confidential meeting with such sponsor in a 
                reasonable time period. If a sponsor requests more than 
                one confidential meeting for the same proposed 
                sunscreen order, the Secretary may refuse to grant an 
                additional confidential meeting request if the 
                Secretary determines that such additional confidential 
                meeting is not reasonably necessary for the sponsor to 
                advance its proposed sunscreen order, or if the request 
                for a confidential meeting fails to include sufficient 
                information upon which to base a substantive 
                discussion. The Secretary shall publish a post-meeting 
                summary of each confidential meeting under this 
                subparagraph that does not disclose confidential 
                commercial information or trade secrets.''.
          (3) Sunset provision.--Subchapter I of chapter V of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.) 
        is amended by adding at the end the following:

``SEC. 586H. SUNSET.

  ``This subchapter shall cease to be effective at the end of fiscal 
year 2022.''.
          (4) Treatment of final sunscreen order.--The Federal Food, 
        Drug, and Cosmetic Act is amended by striking section 586E of 
        such Act (21 U.S.C. 360fff-5).
  (c) Treatment of Non-Sunscreen Time and Extent Applications.--
          (1) In general.--Any application described in section 586F of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-6) 
        that was submitted to the Secretary of Health and Human 
        Services pursuant to section 330.14 of title 21, Code of 
        Federal Regulations, as such provisions were in effect 
        immediately prior to the date of enactment date of this Act, 
        shall be extinguished as of such date of enactment, subject to 
        paragraph (2).
          (2) Order request.--Nothing in paragraph (1) precludes the 
        submission of an order request under section 505G(b) of the 
        Federal Food, Drug, and Cosmetic Act, as added by section 101 
        of this Act, with respect to a drug that was the subject of an 
        application extinguished under paragraph (1).

SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE PEDIATRIC INDICATION 
                    FOR CERTAIN OTC COUGH AND COLD DRUGS.

  (a) In General.--Subject to subsection (c), the Secretary of Health 
and Human Services shall, beginning not later than one year after the 
date of enactment of this Act, annually submit to the Committee on 
Energy and Commerce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate 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 order process under section 
        505G(b) of the Federal Food, Drug, and Cosmetic Act, as added 
        by section 101 of this Act.
  (b) Cough and Cold Monograph Described.--The cough and cold monograph 
described in this subsection consists of the conditions under which 
nonprescription drugs 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 
immediately prior to the date of enactment of this Act), and included 
in an order deemed to be established under section 505G(b) of the 
Federal Food, Drug, and Cosmetic Act, as added by section 101 of this 
Act.
  (c) Duration of Authority.--The requirement under subsection (a) 
shall terminate as of the date of a letter submitted by the Secretary 
of Health and Human Services pursuant to such subsection in which the 
Secretary indicates that the Food and Drug Administration has completed 
its evaluation and revised, in a final order, as applicable, the cough 
and cold monograph as described in subsection (a)(2).

                          TITLE II--USER FEES

SEC. 201. SHORT TITLE; FINDING.

  (a) Short Title.--This title may be cited as the ``Over-the-Counter 
Monograph User Fee Act of 2018''.
  (b) Finding.--The Congress finds that the fees authorized by the 
amendments made in this title will be dedicated to OTC monograph drug 
activities, as set forth in the goals identified for purposes of part 
10 of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act, 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. FEES RELATING TO OVER-THE-COUNTER DRUGS.

  Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379f et seq.) is amended by inserting after part 9 the 
following:

           ``PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS

``SEC. 744N. DEFINITIONS.

  ``In 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 an OTC monograph drug facility where neither the owner of 
        such manufacturing facility nor any affiliate of such owner or 
        facility sells the OTC monograph drug produced at such facility 
        directly to wholesalers, retailers, or consumers in the United 
        States.
          ``(3) The term `costs of resources allocated for OTC 
        monograph drug activities' means the expenses in connection 
        with OTC 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 costs 
                related 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 744O and 
                accounting for resources allocated for OTC monograph 
                drug activities.
          ``(4) The term `FDA establishment identifier' is the unique 
        number automatically generated by Food and Drug 
        Administration's Field Accomplishments and Compliance Tracking 
        System (FACTS) (or any successor system).
          ``(5) The term `OTC monograph drug' means a nonprescription 
        drug without an approved new drug application which is governed 
        by the provisions of section 505G.
          ``(6) The term `OTC monograph drug activities' means 
        activities of the Secretary associated with OTC monograph drugs 
        and inspection of facilities associated with such products, 
        including the following activities:
                  ``(A) The activities necessary for review and 
                evaluation of OTC monographs and OTC monograph order 
                requests, including--
                          ``(i) orders proposing or finalizing 
                        applicable conditions of use for OTC monograph 
                        drugs;
                          ``(ii) orders affecting status regarding 
                        general recognition of safety and effectiveness 
                        of an OTC monograph ingredient or combination 
                        of ingredients under specified conditions of 
                        use;
                          ``(iii) all OTC monograph drug development 
                        and review activities, including intraagency 
                        collaboration;
                          ``(iv) regulation and policy development 
                        activities related to OTC monograph drugs;
                          ``(v) development of product standards for 
                        products subject to review and evaluation;
                          ``(vi) meetings referred to in section 
                        505G(i);
                          ``(vii) review of labeling prior to issuance 
                        of orders related to OTC monograph drugs or 
                        conditions of use; and
                          ``(viii) regulatory science activities 
                        related to OTC monograph drugs.
                  ``(B) Inspections related to OTC monograph drugs.
                  ``(C) Monitoring of clinical and other research 
                conducted in connection with OTC monograph drugs.
                  ``(D) Safety activities with respect to OTC monograph 
                drugs, including--
                          ``(i) collecting, developing, and reviewing 
                        safety information on OTC 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.
                  ``(E) Other activities necessary for implementation 
                of section 505G.
          ``(7) The term `OTC monograph order request' means a request 
        for an order submitted under section 505G(b)(5).
          ``(8) The term `Tier 1 OTC monograph order request' means any 
        OTC monograph order request not determined to be a Tier 2 OTC 
        monograph order request.
          ``(9)(A) The term `Tier 2 OTC monograph order request' means, 
        subject to subparagraph (B), an OTC monograph order request 
        for--
                  ``(i) the reordering of existing information in the 
                drug facts label of an OTC monograph drug;
                  ``(ii) the addition of information to the other 
                information section of the drug facts label of an OTC 
                monograph drug, as limited by section 201.66(c)(7) of 
                title 21, Code of Federal Regulations (or any successor 
                regulations);
                  ``(iii) modification to the directions for use 
                section of the drug facts label of an OTC monograph 
                drug, if such changes conform to changes made pursuant 
                to section 505G(c)(3)(A);
                  ``(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 section 330.1 of title 21, Code of 
                Federal Regulations (or any successor regulations).
          ``(B) The Secretary may, based on program implementation 
        experience or other factors found appropriate by the Secretary, 
        characterize any OTC monograph order request as a Tier 2 OTC 
        monograph order request (including recharacterizing a request 
        from Tier 1 to Tier 2) and publish such determination in a 
        proposed order issued pursuant to section 505G.
          ``(10)(A) The term `OTC monograph drug facility' means a 
        foreign or domestic business or other entity that--
                  ``(i) is--
                          ``(I) under one management, either direct or 
                        indirect; and
                          ``(II) at one geographic location or address 
                        engaged in manufacturing or processing the 
                        finished dosage form of an OTC monograph drug;
                  ``(ii) includes a finished dosage form manufacturer 
                facility in a contractual relationship with the sponsor 
                of one or more OTC monograph drugs to manufacture or 
                process such drugs; and
                  ``(iii) does not include a business or other entity 
                whose only manufacturing or processing activities are 
                one or more of the following: production of clinical 
                research supplies, or testing.
          ``(B) For purposes of subparagraph (A)(i)(II), separate 
        buildings or locations within close proximity are considered to 
        be at one geographic location or address if the activities 
        conducted in such buildings or locations are--
                  ``(i) closely related to the same business 
                enterprise;
                  ``(ii) under the supervision of the same local 
                management; and
                  ``(iii) under a single FDA 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 criteria 
        specified in subparagraph (A), 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.
          ``(11) The term `OTC monograph drug meeting' means any 
        meeting regarding the content of a proposed OTC monograph order 
        request.
          ``(12) The term `person' includes an affiliate of a person.
          ``(13) The terms `requestor' and `sponsor' have the meanings 
        given such terms in section 505G.

``SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH 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.--Each person that owns a facility 
                identified as an OTC 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) Exceptions.--
                          ``(i) A fee shall not be assessed under 
                        subparagraph (A) if the identified OTC 
                        monograph drug facility has ceased all 
                        activities related to OTC monograph drugs prior 
                        to the date specified in subparagraph (D)(ii) 
                        and has updated its registration to reflect 
                        such change under the requirements for drug 
                        establishment registration set forth in section 
                        510.
                          ``(ii) The amount of the fee for a contract 
                        manufacturing organization facility shall be 
                        equal to \2/3\ the amount of the fee for an OTC 
                        monograph drug facility that is not a contract 
                        manufacturing organization facility.
                  ``(C) Amount.--The amount of fees established under 
                subparagraph (A) shall be established under subsection 
                (c).
                  ``(D) 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 enactment of an appropriations Act 
                                providing for the collection and 
                                obligation of fees under this section 
                                for such year.
          ``(2) OTC monograph order request fee.--
                  ``(A) In general.--Each person that submits an OTC 
                monograph order request shall be subject to a fee for 
                an OTC monograph order request. The amount of such fee 
                shall be--
                          ``(i) for a Tier 1 OTC monograph order 
                        request, $500,000, adjusted for inflation for 
                        the fiscal year (as determined under subsection 
                        (c)(1)(B)); and
                          ``(ii) for a Tier 2 OTC monograph order 
                        request, $100,000 adjusted for inflation for 
                        the fiscal year (as determined under subsection 
                        (c)(1)(B)).
                  ``(B) Due date.--The OTC monograph order request fees 
                required under subparagraph (A) shall be due on the 
                date of submission of the OTC monograph order request.
                  ``(C) Exception for certain safety changes.--A person 
                who is named as the requestor in an OTC monograph order 
                shall not be subject to a fee under subparagraph (A) if 
                the Secretary finds that the OTC monograph order 
                request seeks to change the drug facts labeling of an 
                OTC monograph drug 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 OTC monograph drug.
                  ``(D) Refund of fee if order request is recategorized 
                as a tier 2 otc monograph order request.--If the 
                Secretary determines that an OTC monograph request 
                initially characterized as Tier 1 shall be re-
                characterized as a Tier 2 OTC monograph 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 which is refused for filing 
                or was withdrawn before being accepted or refused for 
                filing.
                  ``(F) Fees for order requests previously refused for 
                filing or withdrawn before filing.--An OTC monograph 
                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 subparagraph shall not be reviewable.
          ``(3) Refunds.--
                  ``(A) In general.--Other than refunds provided in 
                subparagraphs (D) through (G) of paragraph (2), the 
                Secretary shall not refund any fee paid under paragraph 
                (1) 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 paragraph (1) or (2), a person shall submit to 
                the Secretary a written request justifying such return 
                within 180 calendar days after such fee was paid.
          ``(4) Notice.--Within the timeframe specified in subsection 
        (c), the Secretary shall publish in the Federal Register the 
        amount of the fees under paragraph (1) for such fiscal year.
  ``(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 (C).
                  ``(B) OTC monograph order request fees.--For purposes 
                of subsection (a)(2), the dollar amount of the 
                inflation adjustment to the fee for OTC monograph order 
                requests for fiscal year 2020 and each subsequent 
                fiscal year shall be equal to the product of--
                          ``(i) the applicable fee under subsection 
                        (a)(2) for the preceding fiscal year; and
                          ``(ii) the inflation adjustment percentage 
                        under subparagraph (C).
                  ``(C) Inflation adjustment percentage.--The inflation 
                adjustment percentage under this subparagraph for a 
                fiscal year is equal to--
                          ``(i) for each of fiscal years 2020 and 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 OTC monograph 
                                drug activities 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 
                                OTC monograph drug activities for the 
                                first 3 years of the preceding 4 fiscal 
                                years.
          ``(2) Operating reserve adjustment.--
                  ``(A) In general.--For fiscal year 2019 and 
                subsequent fiscal years, for purposes of subsections 
                (b)(1)(B) and (b)(2)(C), the Secretary may, in addition 
                to adjustments under paragraph (1), further increase 
                the fee revenue and fees if such an adjustment is 
                necessary to provide operating reserves of carryover 
                user fees for OTC monograph drug activities for not 
                more than the number of weeks specified in subparagraph 
                (B).
                  ``(B) Number of weeks.--The number of weeks specified 
                in this subparagraph is--
                          ``(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) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 10 weeks of the 
                operating reserves referred to in subparagraph (A), the 
                Secretary shall decrease the fee revenue and fees 
                referred to in such subparagraph to provide for not 
                more than 10 weeks of such operating reserves.
                  ``(D) Rationale for adjustment.--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 (4) 
                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 and fees for purposes of 
        subsection (b)(2)(D) 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 OTC monograph drug facility 
                        fees for fiscal year 2019 under subsection (a), 
                        based on the revenue amount for such year under 
                        subsection (b) and the adjustments provided 
                        under this subsection; and
                          ``(ii) publish fee revenue, facility fees, 
                        and OTC monograph order requests 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) OTC monograph drug facility fees under 
                        subsection (a)(1);
                          ``(ii) OTC monograph order request fees under 
                        subsection (a)(2); and
                          ``(iii) publish such fee revenue amounts, 
                        facility fees, and OTC monograph order request 
                        fees in the Federal Register.
  ``(d) Identification of Facilities.--Each person that owns an OTC 
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 
        an OTC monograph drug facility.
  ``(e) Effect of Failure To Pay Fees.--
          ``(1) OTC monograph drug facility fee.--
                  ``(A) In general.--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 following:
                          ``(i) The Secretary shall place the facility 
                        on a publicly available arrears list.
                          ``(ii) All OTC monograph drugs manufactured 
                        in such a facility or containing an ingredient 
                        manufactured in such a facility shall be deemed 
                        misbranded under section 502(a).
                  ``(B) Application of penalties.--The penalties under 
                this paragraph shall apply until the fee established by 
                subsection (a)(1) is paid.
          ``(2) Order requests.--An OTC monograph 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 
        under this section have been paid.
          ``(3) Meetings.--A person subject to fees under this section 
        shall be considered ineligible for OTC monograph drug meetings 
        until all such fees owed by such person have been paid.
  ``(f) 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 
        OTC 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 
                OTC 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 
                collected under this section) no less than $12,000,000, 
                multiplied by the adjustment factor applicable to the 
                fiscal year involved under subsection (c)(1).
                  ``(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 OTC 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.
  ``(g) 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, United States Code.
  ``(h) 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 OTC monograph drug activities, be reduced to 
offset the number of officers, employees, and advisory committees so 
engaged.

``SEC. 744P. 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 Energy and Commerce of the 
House of Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report concerning the progress of the Food 
and Drug Administration in achieving the goals identified in the 
letters described in section 201(b) of the Over-the-Counter Monograph 
Safety, Innovation, and Reform Act of 2018 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 Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate 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 the Congress with respect to the goals described in 
        subsection (a), and plans for meeting the goals, for OTC 
        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 Energy and Commerce of the 
                House of Representatives;
                  ``(B) the Committee on Health, Education, Labor, and 
                Pensions of the Senate;
                  ``(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 the 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.''.

                          Purpose and Summary

    The legislation would amend the Federal Food, Drug, and 
Cosmetic Act to reform the over-the-counter (OTC) monograph 
regulatory framework. To streamline the current regulatory 
process, the legislation would create a system for future 
changes to OTC monographs to be done through an administrative 
order procedure with the opportunity for development meetings 
or other consultations, submission of comments on proposed 
orders, and dispute resolution procedures. To transition the 
OTC monograph framework to an administrative order process, the 
legislation includes, by reference, the OTC Drug Review Final 
Monographs and Tentative Final Monographs in the statute. The 
legislation would also create a mechanism for faster safety 
label changes and establish a pathway for innovations under the 
monographs. To support these reforms, the legislation would 
authorize a new user fee program subject to agreement between 
the Food and Drug Administration (FDA) and manufacturers on 
performance goals, reporting milestones, and financial 
specifications.

                  Background and Need for Legislation

    An OTC drug can be marketed if FDA approves a new drug 
application or if the drug conforms to a monograph, which is a 
set of standard specifications established by FDA for each 
therapeutic category of product. If a product conforms to these 
specifications, FDA considers it to be generally recognized as 
safe and effective and it can be marketed without a product-
specific application being approved by the agency. FDA began 
evaluating twenty-six therapeutic categories of OTC drug 
products in 1972 and has yet to finalize monographs for each of 
them. Due in large part to the multi-phase public rulemaking 
process required even for changes to the monograph, such as 
label warnings or new dosage forms, the current process is 
inefficient and does not enable product advancements to reach 
consumers quickly.

                            Committee Action

    On September 13, 2017, the Subcommittee on Health held a 
hearing on a discussion draft entitled ``Over-the-Counter 
Monograph Safety, Innovation, and Reform Act of 2018.'' The 
Subcommittee received testimony from:
           Janet Woodcock, M.D., Director, Center for 
        Drug Evaluation and Research, Food and Drug 
        Administration;
           Scott Melville, President and CEO, Consumer 
        Health Products Association;
           Kirsten Moore, Project Director, Health Care 
        Products, The Pew Charitable Trusts;
           Michael Werner, Partner, Holland and Knight, 
        on behalf of the Public Access to SunScreens (PASS) 
        Coalition;
           Bridgette Jones, M.D., Chair, American 
        Academy of Pediatrics; and
           Gil Roth, President, Pharma and Biopharma 
        Outsourcing Association.
    On January 17, 2018, the Subcommittee on Health met in open 
markup session and forwarded the discussion draft, without 
amendment, to the full Committee by a voice vote. On May 9, 
2018, the full Committee on Energy and Commerce met in open 
markup session and ordered H.R. 5333, as amended, favorably 
reported to the House by a voice vote. H.R. 5333 was similar to 
the discussion draft forwarded to the full Committee.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 5333 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, the following is 
the cost estimate provided by the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.

Opioid Legislation

    Summary: On May 9 and May 17, 2018, the House Committee on 
Energy and Commerce ordered 59 bills to be reported related to 
the nation's response to the opioid epidemic. Generally, the 
bills would:
           Provide grants to facilities and providers 
        that treat people with substance use disorders,
           Direct various agencies within the 
        Department of Health and Human Services (HHS) to 
        explore nonopioid approaches to treating pain and to 
        educate providers about those alternatives,
           Modify requirements under Medicaid and 
        Medicare for prescribing controlled substances,
           Expand Medicaid coverage for substance abuse 
        treatment, and
           Direct the Food and Drug Administration 
        (FDA) to modify its oversight of opioid drugs and other 
        medications that are used to manage pain.
    Because of the large number of related bills ordered 
reported by the Committee, CBO is publishing a single 
comprehensive document that includes estimates for each piece 
of legislation.
    CBO estimates that enacting 20 of the bills would affect 
direct spending, and 2 of the bills would affect revenues; 
therefore, pay-as-you-go procedures apply for those bills.
    CBO estimates that enacting H.R. 4998, the Health Insurance 
for Former Foster Youth Act, would increase net direct spending 
by more than $2.5 billion and on-budget deficits by more than 
$5 billion in at least one of the four consecutive 10-year 
periods beginning in 2029. None of the remaining 58 bills 
included in this estimate would increase net direct spending by 
more than $2.5 billion or on-budget deficits by more than $5 
billion in any of the four consecutive 10-year periods 
beginning in 2029.
    One of the bills reviewed for this document, H.R. 5795, 
would impose both intergovernmental and private-sector mandates 
as defined in the Unfunded Mandates Reform Act (UMRA). CBO 
estimates that the costs of those mandates on public and 
private entities would fall below the thresholds in UMRA ($80 
million and $160 million, respectively, in 2018, adjusted 
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R. 
5554, H.R. 5687, and H.R. 5811, would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of the bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would not exceed the UMRA threshold for private 
entities. Because CBO is uncertain how federal agencies would 
implement new authority granted in the other two bills, H.R. 
5228 and H.R. 5687, CBO cannot determine whether the costs of 
those mandates would exceed the UMRA threshold.
    Estimated cost to the Federal Government: The estimates in 
this document do not include the effects of interactions among 
the bills. If all 59 bills were combined and enacted as one 
piece of legislation, the budgetary effects would be different 
from the sum of the estimates in this document, although CBO 
expects that any such differences would be small. The costs of 
this legislation fall within budget functions 550 (health), 570 
(Medicare), 750 (administration of justice), and 800 (general 
government).
    Basis of estimate: For this estimate, CBO assumes that all 
of the legislation will be enacted late in 2018 and that 
authorized and estimated amounts will be appropriated each 
year. Outlays for discretionary programs are estimated based on 
historical spending patterns for similar programs.

Uncertainty

    CBO aims to produce estimates that generally reflect the 
middle of a range of the most likely budgetary outcomes that 
would result if the legislation was enacted. Because data on 
the utilization of mental health and substance abuse treatment 
under Medicaid and Medicare is scarce, CBO cannot precisely 
predict how patients or providers would respond to some policy 
changes or what budgetary effects would result. In addition, 
several of the bills would give the Department of Health and 
Human Services (HHS) considerable latitude in designing and 
implementing policies. Budgetary effects could differ from 
those provided in CBO's analyses depending on those decisions.

Direct Spending and Revenues

    Table 1 lists the 22 bills of the 59 ordered to be reported 
that would affect direct spending or revenues.

                                             TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            By fiscal year, in millions of dollars--
                                      ------------------------------------------------------------------------------------------------------------------
                                        2018   2019   2020    2021     2022     2023     2024     2025     2026     2027     2028   2019-2023  2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      INCREASES OR DECREASES (-) IN DIRECT SPENDING
 
Legislation Primarily Affecting
 Medicaid:
    H.R. 1925, At-Risk Youth Medicaid      0      *      5        5        5       10       10       10       10       10       10         25         75
     Protection Act of 2017..........
    H.R. 4998, Health Insurance for        0      0      0        0        0        *       10       21       33       46       61          *        171
     Former Foster Youth Act.........
    H.R. 5477, Rural Development of        0     13     35       58       68       83       27        9        3        3        3        256        301
     Opioid Capacity Services Act....
    H.R. 5583, a bill to amend title       0      *      *        *        *        *        *        *        *        *        *          *          *
     XI of the Social Security Act to
     require States to annually
     report on certain adult health
     quality measures, and for other
     purposes........................
    H.R. 5797, IMD CARE Act..........      0     38    158      251      265      279        0        0        0        0        0        991        991
    H.R. 5799, Medicaid DRUG               0      *      *        1        1        1        1        1        1        1        1          2          5
     Improvement Acta................
    H.R. 5801, Medicaid Providers Are      0      *      *        *        *        *        *        *        *        *        *          *          *
     Required To Note Experiences in
     Record Systems to Help In-Need
     Patients (PARTNERSHIP) Act a....
    H.R. 5808, Medicaid                    0      *     -1       -1       -1       -1       -2       -2       -2       -2       -2         -4        -13
     Pharmaceutical Home Act of 2018a
    H.R. 5810, Medicaid Health HOME        0     94     58       62       56       52       48       43       38       32       25        323        509
     Act.............................
Legislation Primarily Affecting
 Medicare:
    H.R. 3528, Every Prescription          0      0      0      -24      -35      -33      -30      -33      -32      -31      -32        -92       -250
     Conveyed Securely Act...........
    H.R. 4841, Standardizing               0      0      0        *        *        *        *        *        *        *        *          *          *
     Electronic Prior Authorization
     for Safe Prescribing Act of 2018
    H.R. 5603, Access to Telehealth        0      2      *        *        *        1        1        1        2        2        2          3         11
     Services for Opioid Use
     Disorders Act...................
    H.R. 5605, Advancing High Quality      0      0      0       15       26       24       23       23       10        1        *         65        122
     Treatment for Opioid Use
     Disorders in Medicare Act.......
    H.R. 5675, a bill to amend title       0      0      0       -6       -7       -7       -7       -8       -9       -9      -11        -20        -64
     XVIII of the Social Security Act
     to require prescription drug
     plan sponsors under the Medicare
     program to establish drug
     management programs for at-risk
     beneficiaries...................
    H.R. 5684, Protecting Seniors          0      0      0        *        *        *        *        *        *        *        *          *          *
     From Opioid Abuse Act...........
    H.R. 5796, Responsible Education       0     10     25       50       10        5        0        0        0        0        0        100        100
     Achieves Care and Healthy
     Outcomes for Users' Treatment
     Act of 2018.....................
    H.R. 5798, Opioid Screening and        0      0      *        1        1        1        1        1        1        1        1          2          5
     Chronic Pain Management
     Alternatives for Seniors Act....
    H.R. 5804, Post-Surgical               0      0     25       30       25       20       10        5        0        0        0        100        115
     Injections as an Opioid
     Alternative Acta................
    H.R. 5809, Postoperative Opioid        0      0      0        0       10       15       20       25       30       35       45         25        180
     Prevention Act of 2018..........
Legislation Primarily Affecting the
 Food and Drug Administration:
    H.R. 5333, Over-the-Counter            0      0      *        *        *        *        *        *        *        *        *          *          *
     Monograph Safety, Innovation,
     and Reform Act of 2018a.........
 
                                                         INCREASES OR DECREASES (-) IN REVENUESb
 
H.R. 5752, Stop Illicit Drug               0      *      *        *        *        *        *        *        *        *        *          *          *
 Importation Act of 2018.............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.

    Legislation Primarily Affecting Medicaid. The following 
nine bills would affect direct spending for the Medicaid 
program.
    H.R. 1925, the At-Risk Youth Medicaid Protection Act of 
2017, would require states to suspend, rather than terminate, 
Medicaid eligibility for juvenile enrollees (generally under 21 
years of age) who become inmates of public correctional 
institutions. States also would have to redetermine those 
enrollees' Medicaid eligibility before their release and 
restore their coverage upon release if they qualify for the 
program. States would be required to process Medicaid 
applications submitted by or on behalf of juveniles in public 
correctional institutions who were not enrolled in Medicaid 
before becoming inmates and ensure that Medicaid coverage is 
provided when they are released if they are found to be 
eligible. On the basis of an analysis of juvenile incarceration 
trends and of the per enrollee spending for Medicaid foster 
care children, who have a similar health profile to 
incarcerated juveniles, CBO estimates that implementing the 
bill would cost $75 million over the 2019-2028 period.
    H.R. 4998, the Health Insurance for Former Foster Youth 
Act, would require states to provide Medicaid coverage to 
adults up to age 25 who had aged out of foster care in any 
state. Under current law, such coverage is mandatory only if 
the former foster care youth has aged out in the state in which 
the individual applies for coverage. The policy also would 
apply to former foster children who had been in foster care 
upon turning 14 years of age but subsequently left foster care 
to enter into a legal guardianship with a kinship caregiver. 
The provisions would take effect respect for foster youth who 
turn 18 on or after January 1, 2023. On the basis of spending 
for Medicaid foster care children and data from the Census 
Bureau regarding annual migration rates between states, CBO 
estimates that implementing the bill would cost $171 million 
over the 2019-2028 period.
    H.R. 5477, the Rural Development of Opioid Capacity 
Services Act, would direct the Secretary of HHS to conduct a 
five-year demonstration to increase the number and ability of 
providers participating in Medicaid to provide treatment for 
substance use disorders. On the basis of an analysis of federal 
and state spending for treatment of substance use disorders and 
the prevalence of such disorders, CBO estimates that enacting 
the bill would increase direct spending by $301 million over 
the 2019-2028 period.
    H.R. 5583, a bill to amend title XI of the Social Security 
Act to require States to annually report on certain adult 
health quality measures, and for other purposes, would require 
states to include behavioral health indicators in their annual 
reports on the quality of care under Medicaid. Although the 
bill would add a requirement for states, CBO estimates that its 
enactment would not have a significant budgetary effect because 
most states have systems in place for reporting such measures 
to the federal government.
    H.R. 5797, the IMD CARE Act, would expand Medicaid coverage 
for people with opioid use disorder who are in institutions for 
mental disease (IMDs) for up to 30 days per year. Under a 
current-law policy known as the IMD exclusion, the federal 
government generally does not make matching payments to state 
Medicaid programs for most services provided by IMDs to adults 
between the ages of 21 and 64. Recent administrative changes 
have made federal financing for IMDs available in limited 
circumstances, but the statutory prohibition remains in place. 
CBO analyzed several data sets, primarily those collected by 
the Substance Abuse and Mental Health Services Administration 
(SAMHSA), to estimate current federal spending under Medicaid 
for IMD services and to estimate spending under H.R. 5797. 
Using that analysis, CBO estimates that enacting H.R. 5797 
would increase direct spending by $991 million over the 2019-
2028 period.
    H.R. 5799, the Medicaid DRUG Improvement Act, would require 
state Medicaid programs to implement additional reviews of 
opioid prescriptions, monitor concurrent prescribing of opioids 
and certain other drugs, and monitor use of antipsychotic drugs 
by children. CBO estimates that the bill would increase direct 
spending by $5 million over the 2019-2028 period to cover the 
administrative costs of complying with those requirements. On 
the basis of stakeholder feedback, CBO expects that the bill 
would not have a significant effect on Medicaid spending for 
prescription drugs because many of the bill's requirements 
would duplicate current efforts to curb opioid and 
antipsychotic drug use. (If enacted, H.R. 5799 also would 
affect spending subject to appropriation; CBO has not completed 
an estimate of that amount.)
    H.R. 5801, the Medicaid Providers Are Required To Note 
Experiences in Record Systems to Help In-Need Patients 
(PARTNERSHIP) Act, would require providers who are permitted to 
prescribe controlled substances and who participate in Medicaid 
to query prescription drug monitoring programs (PDMPs) before 
prescribing controlled substances to Medicaid patients. PDMPs 
are statewide electronic databases that collect data on 
controlled substances dispensed in the state. The bill also 
would require PDMPs to comply with certain data and system 
criteria, and it would provide additional federal matching 
funds to certain states to help cover administrative costs. On 
the basis of a literature review and stakeholder feedback, CBO 
estimates that the net budgetary effect of enacting H.R. 5801 
would be insignificant. Costs for states to come into 
compliance with the systems and administrative requirements 
would be roughly offset by savings from small reductions in the 
number of controlled substances paid for by Medicaid under the 
proposal. (If enacted, H.R. 5801 also would affect spending 
subject to appropriation; CBO has not completed an estimate of 
that amount.)
    H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018, 
would require state Medicaid programs to operate pharmacy 
programs that would identify people at high risk of abusing 
controlled substances and require those patients to use a 
limited number of providers and pharmacies. Although nearly all 
state Medicaid programs currently meet such a requirement, a 
small number of high-risk Medicaid beneficiaries are not now 
monitored. Based on an analysis of information about similar 
state and federal programs, CBO estimates that net Medicaid 
spending under the bill would decrease by $13 million over the 
2019-2028 period. That amount represents a small increase in 
administrative costs and a small reduction in the number of 
controlled substances paid for by Medicaid under the proposal. 
(If enacted, H.R. 5808 also would affect spending subject to 
appropriation; CBO has not completed an estimate of that 
amount.)
    H.R. 5810, the Medicaid Health HOME Act, would allow states 
to receive six months of enhanced federal Medicaid funding for 
programs that coordinate care for people with substance use 
disorders. Based on enrollment and spending data from states 
that currently participate in Medicaid's Health Homes program, 
CBO estimates that the expansion would cost approximately $469 
million over the 2019-2028 period. The bill also would require 
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a 
waiver from that requirement. (Medication-assisted treatment 
combines behavioral therapy and pharmaceutical treatment for 
substance use disorders.) Under current law, states already 
cover most FDA-approved drugs used in such programs in some 
capacity, although a few exclude methadone dispensed by opioid 
treatment programs. CBO estimates that a small share of those 
states would begin to cover methadone if this bill was enacted 
at a federal cost of about $39 million over the 2019-2028 
period. In sum, CBO estimates that enacting H.R. 5810 would 
increase direct spending by $509 million over the 2019-2028 
period.
    Legislation Primarily Affecting Medicare. The following ten 
bills would affect direct spending for the Medicare program.
    H.R. 3528, the Every Prescription Conveyed Securely Act, 
would require prescriptions for controlled substances covered 
under Medicare Part D to be transmitted electronically, 
starting on January 1, 2021. Based on CBO's analysis of 
prescription drug spending, spending for controlled substances 
is a small share of total drug spending. CBO also assumes a 
small share of those prescriptions would not be filled because 
they are not converted to an electronic format. Therefore, CBO 
expects that enacting H.R. 3528 would reduce the number of 
prescriptions filled and estimates that Medicare spending would 
be reduced by $250 million over the 2019-2028 period.
    H.R. 4841, the Standardizing Electronic Prior Authorization 
for Safe Prescribing Act of 2018, would require health care 
professionals to submit prior authorization requests 
electronically, starting on January 1, 2021, for drugs covered 
under Medicare Part D. Taking into account that many 
prescribers already use electronic methods to submit such 
requests, CBO estimates that enacting H.R. 4841 would not 
significantly affect direct spending for Part D.
    H.R. 5603, the Access to Telehealth Services for Opioid Use 
Disorders Act, would permit the Secretary of HHS to lift 
current geographic and other restrictions on coverage of 
telehealth services under Medicare for treatment of substance 
use disorders or co-occurring mental health disorders. Under 
the bill, the Secretary of HHS would be directed to encourage 
other payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on current use of Medicare 
telehealth services for treatment of substance use disorders, 
CBO estimates that expanding that coverage would increase 
direct spending by $11 million over the 2019-2028 period.
    H.R. 5605, the Advancing High Quality Treatment for Opioid 
Use Disorders in Medicare Act, would establish a five-year 
demonstration program to increase access to treatment for 
opioid use disorder. The demonstration would provide incentive 
payments and funding for care management services based on 
criteria such as patient engagement, use of evidence-based 
treatments, and treatment length and intensity. Under the bill, 
the Secretary of HHS would be directed to encourage other 
payers to coordinate payments for opioid use disorder 
treatments and to evaluate the extent to which the 
demonstration reduces hospitalizations, increases the use of 
medication-assisted treatments, and improves the health 
outcomes of individuals with opioid use disorders during and 
after the demonstration. Based on historical utilization of 
opioid use disorder treatments and projected spending on 
incentive payments and care management fees, CBO estimates that 
increased use of treatment services and the demonstration's 
incentive payments would increase direct spending by $122 
million over the 2019-2028 period.
    H.R. 5675, a bill to amend title XVIII of the Social 
Security Act to require prescription drug plan sponsors under 
the Medicare program to establish drug management programs for 
at-risk beneficiaries, would require Part D prescription drug 
plans to provide drug management programs for Medicare 
beneficiaries who are at risk for prescription drug abuse. 
(Under current law, Part D plans are permitted but not required 
to establish such programs as of 2019.) Based on an analysis of 
the number of plans currently providing those programs, CBO 
estimates that enacting H.R. 5675 would lower federal spending 
by $64 million over the 2019-2028 period by reducing the number 
of prescriptions filled and Medicare's payments for controlled 
substances.
    H.R. 5684, the Protecting Seniors From Opioid Abuse Act, 
would expand medication therapy management programs under 
Medicare Part D to include beneficiaries who are at risk for 
prescription drug abuse. Because relatively few beneficiaries 
would be affected by this bill, CBO estimates that its 
enactment would not significantly affect direct spending for 
Part D.
    H.R. 5796, the Responsible Education Achieves Care and 
Healthy Outcomes for Users' Treatment Act of 2018, would allow 
the Secretary of HHS to award grants to certain organizations 
that provide technical assistance and education to high-volume 
prescribers of opioids. The bill would appropriate $100 million 
for fiscal year 2019. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 5796 
would cost $100 million over the 2019-2028 period.
    H.R. 5798, the Opioid Screening and Chronic Pain Management 
Alternatives for Seniors Act, would add an assessment of 
current opioid prescriptions and screening for opioid use 
disorder to the Welcome to Medicare Initial Preventive Physical 
Examination. Based on historical use of the examinations and 
pain management alternatives, CBO expects that enacting the 
bill would increase use of pain management services and 
estimates that direct spending would increase by $5 million 
over the 2019-2028 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative Act, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers (ASCs). (For injections identified by specific billing 
codes, Medicare would pay the 2016 rate, which is higher than 
the current rate, during the 2020-2024 period.) Based on 
current utilization in the ASC setting, CBO estimates that 
enacting the legislation would increase direct spending by 
about $115 million over the 2019-2028 period. (If enacted, H.R. 
5804 also would affect spending subject to appropriation; see 
Table 3.)
    H.R. 5809, the Postoperative Opioid Prevention Act of 2018, 
would create an additional payment under Medicare for nonopioid 
analgesics. Under current law, certain new drugs and devices 
may receive an additional payment--separate from the bundled 
payment for a surgical procedure--in outpatient hospital 
departments and ambulatory surgical centers. The bill would 
allow nonopioid analgesics to qualify for a five-year period of 
additional payments. Based on its assessment of current 
spending for analgesics and on the probability of new nonopioid 
analgesics coming to market, CBO estimates that H.R. 5809 would 
increase direct spending by about $180 million over the 2019-
2028 period.
    Legislation Primarily Affecting the Food and Drug 
Administration. One bill related to the FDA would affect direct 
spending.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would change the way that 
the FDA regulates the marketing of over-the-counter (OTC) 
medicines, and it would authorize that agency to grant 18 
months of exclusive market protection for certain qualifying 
OTC drugs, thus delaying the entry of other versions of the 
same qualifying OTC product. Medicaid currently provides some 
coverage for OTC medicines, but only if a medicine is the least 
costly alternative in its drug class. On the basis of 
stakeholder feedback, CBO expects that delaying the 
availability of additional OTC versions of a drug would not 
significantly affect the average net price paid by Medicaid. As 
a result, CBO estimates that enacting H.R. 5333 would have a 
negligible effect on the federal budget. (If enacted, H.R. 5333 
also would affect spending subject to appropriation; see Table 
3.)
    Legislation with Revenue Effects. Two bills would affect 
revenues. However, CBO estimates that one bill, H.R. 5228, the 
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement 
Now Act, would have only a negligible effect.
    H.R. 5752, the Stop Illicit Drug Importation Act of 2018, 
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to 
strengthen the FDA's seizure powers and enhance its authority 
to detain, refuse, seize, or destroy illegal products offered 
for import. The legislation would subject more people to 
debarment under the FDCA and thus increase the potential for 
violations, and subsequently, the assessment of civil 
penalties, which are recorded in the budget as revenues. CBO 
estimates that those collections would result in an 
insignificant increase in revenues. Because H.R. 5752 would 
prohibit the importation of drugs that are in the process of 
being scheduled, it also could reduce amounts collected in 
customs duties. CBO anticipates that the result would be a 
negligible decrease in revenues. With those results taken 
together, CBO estimates, enacting H.R. 5752 would generate an 
insignificant net increase in revenues over the 2019-2028 
period.

Spending Subject to Appropriation

    For this document, CBO has grouped bills with spending that 
would be subject to appropriation into four general categories:
           Bills that would have no budgetary effect,
           Bills with provisions that would authorize 
        specified amounts to be appropriated (see Table 2),
           Bills with provisions for which CBO has 
        estimated an authorization of appropriations (see Table 
        3), and
           Bills with provisions that would affect 
        spending subject to appropriation for which CBO has not 
        yet completed an estimate.
    No Budgetary Effect. CBO estimates that 6 of the 59 bills 
would have no effect on direct spending, revenues, or spending 
subject to appropriation.
    H.R. 3192, the CHIP Mental Health Parity Act, would require 
all Children's Health Insurance Program (CHIP) plans to cover 
mental health and substance abuse treatment. In addition, 
states would not be allowed to impose financial or utilization 
limits on mental health treatment that are lower than limits 
placed on physical health treatment. Based on information from 
the Centers for Medicare and Medicaid Services, CBO estimates 
that enacting the bill would have no budgetary effect because 
all CHIP enrollees are already in plans that meet those 
requirements.
    H.R. 3331, a bill to amend title XI of the Social Security 
Act to promote testing of incentive payments for behavioral 
health providers for adoption and use of certified electronic 
health record technology, would give the Center for Medicare 
and Medicaid Innovation (CMMI) explicit authorization to test a 
program offering incentive payments to behavioral health 
providers that adopt and use certified electronic health record 
technology. Because it is already clear to CMMI that it has 
that authority, CBO estimates that enacting the legislation 
would not affect federal spending.
    H.R. 5202, the Ensuring Patient Access to Substance Use 
Disorder Treatments Act of 2018, would clarify permission for 
pharmacists to deliver controlled substances to providers under 
certain circumstances. Because this provision would codify 
current practice, CBO estimates that H.R. 5202 would not affect 
direct spending or revenues during the 2019-2028 period.
    H.R. 5685, the Medicare Opioid Safety Education Act of 
2018, would require the Secretary of HHS to include information 
on opioid use, pain management, and nonopioid pain management 
treatments in future editions of Medicare & You, the program's 
handbook for beneficiaries, starting on January 1, 2019. 
Because H.R. 5685 would add information to an existing 
administrative document, CBO estimates that enacting the bill 
would have no budgetary effect.
    H.R. 5686, the Medicare Clear Health Options in Care for 
Enrollees Act of 2018, would require prescription drug plans 
that provide coverage under Medicare Part D to furnish 
information to beneficiaries about the risks of opioid use and 
the availability of alternative treatments for pain. CBO 
estimates that enacting the bill would not affect direct 
spending because the required activities would not impose 
significant administrative costs.
    H.R. 5716, the Commit to Opioid Medical Prescriber 
Accountability and Safety for Seniors Act, would require the 
Secretary of HHS on an annual basis to identify high 
prescribers of opioids and furnish them with information about 
proper prescribing methods. Because HHS already has the 
capacity to meet those requirements, CBO estimates that 
enacting that provision would not impose additional 
administrative costs on the agency.
    Specified Authorizations. Table 2 lists the ten bills that 
would authorize specified amounts to be appropriated over the 
2019-2023 period. Spending from those authorized amounts would 
be subject to appropriation.

          TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
                                                                   By fiscal year, in millions of dollars--
                                                            ----------------------------------------------------
                                                              2018   2019   2020   2021   2022   2023  2019-2023
----------------------------------------------------------------------------------------------------------------
                                 INCREASES IN SPENDING SUBJECT TO APPROPRIATION
 
H.R. 4684, Ensuring Access to Quality Sober Living Act:
    Authorization Level....................................      0      3      0      0      0      0         3
    Estimated Outlays......................................      0      1      2      *      *      *         3
H.R. 5102, Substance Use Disorder Workforce Loan Repayment
 Act of 2018:
    Authorization Level....................................      0     25     25     25     25     25       125
    Estimated Outlays......................................      0      9     19     23     25     25       100
H.R. 5176, Preventing Overdoses While in Emergency Rooms
 Act of 2018:
    Authorization Level....................................      0     50      0      0      0      0        50
    Estimated Outlays......................................      0     16     26      6      2      1        50
H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency
 Department Act:
    Authorization Level....................................      0     10     10     10      0      0        30
    Estimated Outlays......................................      0      3      8     10      7      2        30
H.R. 5261, Treatment, Education, and Community Help to
 Combat Addiction Act of 2018:
    Authorization Level....................................      0      4      4      4      4      4        20
    Estimated Outlays......................................      0      1      3      4      4      4        16
H.R. 5327, Comprehensive Opioid Recovery Centers Act of
 2018:
    Authorization Level....................................      0     10     10     10     10     10        50
    Estimated Outlays......................................      0      3      8     10     10     10        41
H.R. 5329, Poison Center Network Enhancement Act of 2018:
    Authorization Level....................................      0     30     30     30     30     30       151
    Estimated Outlays......................................      0     12     25     29     29     29       125
H.R. 5353, Eliminating Opioid-Related Infectious Diseases
 Act of 2018:
    Authorization Level....................................      0     40     40     40     40     40       200
    Estimated Outlays......................................      0     15     34     38     39     40       166
H.R. 5580, Surveillance and Testing of Opioids to Prevent
 Fentanyl Deaths Act of 2018:
    Authorization Level....................................     30     30     30     30     30      0       120
    Estimated Outlays......................................      0     11     25     29     29     19       113
H.R. 5587, Peer Support Communities of Recovery Act:
    Authorization Level....................................      0     15     15     15     15     15        75
    Estimated Outlays......................................      0      5     13     14     15     15        62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.

    H.R. 4684, the Ensuring Access to Quality Sober Living Act, 
would direct the Secretary of HHS to develop and disseminate 
best practices for organizations that operate housing designed 
for people recovering from substance use disorders. The bill 
would authorize a total of $3 million over the 2019-2021 period 
for that purpose. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 4684 
would cost $3 million over the 2019-2023 period.
    H.R. 5102, the Substance Use Disorder Workforce Loan 
Repayment Act of 2018, would establish a loan repayment program 
for mental health professionals who practice in areas with few 
mental health providers or with high rates of death from 
overdose and would authorize $25 million per year over the 
2019-2028 period for that purpose. Based on historical spending 
patterns for similar activities, CBO estimates that 
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years 
after 2023.
    H.R. 5176, the Preventing Overdoses While in Emergency 
Rooms Act of 2018, would require the Secretary of HHS to 
develop protocols and a grant program for health care providers 
to address the needs of people who survive a drug overdose, and 
it would authorize $50 million in 2019 for that purpose. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5176 would cost $50 million 
over the 2019-2023 period.
    H.R. 5197, the Alternatives to Opioids (ALTO) in the 
Emergency Department Act, would direct the Secretary of HHS to 
carry out a demonstration program for hospitals and emergency 
departments to develop alternative protocols for pain 
management that limit the use of opioids and would authorize 
$10 million annually in grants for fiscal years 2019 through 
2021. Based on historical spending patterns for similar 
programs, CBO estimates that implementing H.R. 5197 would cost 
$30 million over the 2019-2023 period.
    H.R. 5261, the Treatment, Education, and Community Help to 
Combat Addiction Act of 2018, would direct the Secretary of HHS 
to designate regional centers of excellence to improve the 
training of health professionals who treat substance use 
disorders. The bill would authorize $4 million annually for 
grants to those programs over the 2019-2023 period. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5261 would cost $16 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5327, the Comprehensive Opioid Recovery Centers Act of 
2018, would direct the Secretary of HHS to award grants to at 
least 10 providers that offer treatment services for people 
with opioid use disorder, and it would authorize $10 million 
per year over the 2019-2023 period for that purpose. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5327 would cost $41 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5329, the Poison Center Network Enhancement Act of 
2018, would reauthorize the poison control center toll-free 
number, national media campaign, and grant program under the 
Public Health Service Act. Among other actions, H.R. 5329 would 
increase the share of poison control center funding that could 
be provided by federal grants. The bill would authorize a total 
of about $30 million per year over the 2019-2023 period. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5329 would cost $125 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    H.R. 5353, the Eliminating Opioid Related Infectious 
Diseases Act of 2018, would amend the Public Health Service Act 
by broadening the focus of surveillance and education programs 
from preventing and treating hepatitis C virus to preventing 
and treating infections associated with injection drug use. It 
would authorize $40 million per year over the 2019-2023 period 
for that purpose. Based on historical spending patterns for 
similar activities, CBO estimates that implementing H.R. 5353 
would cost $166 million over the 2019-2023 period; the 
remaining amounts would be spent in years after 2023.
    H.R. 5580, the Surveillance and Testing of Opioids to 
Prevent Fentanyl Deaths Act of 2018, would establish a grant 
program for public health laboratories that conduct testing for 
fentanyl and other synthetic opioids. It also would direct the 
Centers for Disease Control and Prevention to expand its drug 
surveillance program, with a particular focus on collecting 
data on fentanyl. The bill would authorize a total of $30 
million per year over the 2018-2022 period for those 
activities. Based on historical spending patterns for similar 
activities, CBO estimates that implementing H.R. 5580 would 
cost $113 million over the 2019-2023 period; the remaining 
amounts would be spent in years after 2023.
    H.R. 5587, Peer Support Communities of Recovery Act, would 
direct the Secretary of HHS to award grants to nonprofit 
organizations that support community-based, peer-delivered 
support, including technical support for the establishment of 
recovery community organizations, independent, nonprofit groups 
led by people in recovery and their families. The bill would 
authorize $15 million per year for the 2019-2023 period. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5587 would cost $62 million 
over the 2019-2023 period; the remaining amounts would be spent 
in years after 2023.
    Estimated Authorizations. Table 3 shows CBO's estimates of 
the appropriations that would be necessary to implement 19 of 
the bills. Spending would be subject to appropriation of those 
amounts.
    H.R. 449, the Synthetic Drug Awareness Act of 2018, would 
require the Surgeon General to report to the Congress on the 
health effects of synthetic psychoactive drugs on children 
between the ages of 12 and 18. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 449 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 4005, the Medicaid Reentry Act, would direct the 
Secretary of HHS to convene a group of stakeholders to develop 
and report to the Congress on best practices for addressing 
issues related to health care faced by those returning from 
incarceration to their communities. The bill also would require 
the Secretary to issue a letter to state Medicaid directors 
about relevant demonstration projects. Based on an analysis of 
anticipated workload, CBO estimates that implementing H.R. 4005 
would cost less than $500,000 over the 2018-2023 period.
    H.R. 4275, the Empowering Pharmacists in the Fight Against 
Opioid Abuse Act, would require the Secretary of HHS to develop 
and disseminate materials for training pharmacists, health care 
practitioners, and the public about the circumstances under 
which a pharmacist may decline to fill a prescription. Based on 
historical spending patterns for similar activities, CBO 
estimates that costs to the federal government for the 
development and distribution of those materials would not be 
significant.

          TABLE 3.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
                                                                By fiscal year, in millions of dollars--
                                                      ----------------------------------------------------------
                                                        2018    2019    2020    2021    2022    2023   2019-2023
----------------------------------------------------------------------------------------------------------------
                                 INCREASES IN SPENDING SUBJECT TO APPROPRIATION
 
H.R. 449, Synthetic Drug Awareness Act of 2018:
    Estimated Authorization Level....................       0       *       *       *       0       0         1
    Estimated Outlays................................       0       *       *       *       0       0         1
H.R. 4005, Medicaid Reentry Act:
    Estimated Authorization Level....................       *       *       0       0       0       0         *
    Estimated Outlays................................       *       *       0       0       0       0         *
H.R. 4275, Empowering Pharmacists in the Fight
 Against Opioid Abuse Act:
    Estimated Authorization Level....................       0       *       *       *       *       *         *
    Estimated Outlays................................       0       *       *       *       *       *         *
H.R. 5009, Jessie's Law:
    Estimated Authorization Level....................       0       *       *       *       *       *         *
    Estimated Outlays................................       0       *       *       *       *       *         *
H.R. 5041, Safe Disposal of Unused Medication Act:
    Estimated Authorization Level....................       0       *       *       *       *       *         *
    Estimated Outlays................................       0       *       *       *       *       *         *
H.R. 5272, Reinforcing Evidence-Based Standards Under
 Law in Treating Substance Abuse Act of 2018:
    Estimated Authorization Level....................       0       1       1       1       1       1         4
    Estimated Outlays................................       0       1       1       1       1       1         4
H.R. 5333, Over-the-Counter Monograph Safety,
 Innovation, and Reform Act of 2018:a
    Food and Drug Administration:
        Collections from fees:
            Estimated Authorization Level............       0     -22     -22     -26     -35     -42      -147
            Estimated Outlays........................       0     -22     -22     -26     -35     -42      -147
        Spending of fees:
            Estimated Authorization Level............       0      22      22      26      35      42       147
            Estimated Outlays........................       0       6      17      30      44      41       137
        Net effect on FDA:
            Estimated Authorization Level............       0       0       0       0       0       0         0
            Estimated Outlays........................       0     -17      -6       4       9       *       -10
    Government Accountability Office:
        Estimated Authorization Level................       0       0       0       0       0       *         *
        Estimated Outlays............................       0       0       0       0       0       *         *
    Total, H.R. 5333:
        Estimated Authorization Level................       0       0       0       0       0       0         *
        Estimated Outlays............................       0     -17      -6       4       9       *       -10
H.R. 5473, Better Pain Management Through Better Data
 Act of 2018:
    Estimated Authorization Level....................       0       *       *       *       *       0         1
    Estimated Outlays................................       0       *       *       *       *       *         1
H.R. 5483, Special Registration for Telemedicine
 Clarification Act of 2018:
    Estimated Authorization Level....................       0       *       *       *       *       *         *
    Estimated Outlays................................       0       *       *       *       *       *         *
H.R. 5554, Animal Drug and Animal Generic Drug User
 Fee Amendments of 2018:
    Collections from fees:
        Animal drug fees.............................       0     -30     -31     -32     -33     -34      -159
        Generic animal drug fees.....................       0     -18     -19     -19     -20     -21       -97
            Total, Estimated Authorization Level.....       0     -49     -50     -51     -53     -55      -257
            Total, Estimated Outlays.................       0     -49     -50     -51     -53     -55      -257
    Spending of fees:
        Animal drug fees.............................       0      30      31      32      33      34       159
        Generic animal drug fees.....................       0      18      19      19      20      21        97
            Total, Estimated Authorization Level.....       0      49      50      51      53      55       257
            Total, Estimated Outlays.................       0      39      47      51      52      54       243
    Net changes in fees:
        Estimated Authorization Level................       0       0       0       0       0       0         0
        Estimated Outlays............................       0     -10      -3       *       *       *       -14
    Other effects:
        Estimated Authorization Level................       0       3       1       1       1       1         6
        Estimated Outlays............................       0       2       1       1       1       1         6
    Total, H.R. 5554:
        Estimated Authorization Level................       0       3       1       1       1       1         6
        Estimated Outlays............................       0      -8      -2       1       *       *        -8
H.R. 5582, Abuse Deterrent Access Act of 2018:
    Estimated Authorization Level....................       0       0       *       0       0       0         *
    Estimated Outlays................................       0       0       *       0       0       0         *
H.R. 5590, Opioid Addiction Action Plan Act:
    Estimated Authorization Level....................       *       *       *       *       *       *         2
    Estimated Outlays................................       *       *       *       *       *       *         2
H.R. 5687, Securing Opioids and Unused Narcotics with
 Deliberate Disposal and Packaging Act of 2018:
    Estimated Authorization Level....................       0       *       *       *       *       *         *
    Estimated Outlays................................       0       *       *       *       *       *         *
H.R. 5715, Strengthening Partnerships to Prevent
 Opioid Abuse Act:
    Estimated Authorization Level....................       0       2       2       2       2       2         9
    Estimated Outlays................................       0       2       2       2       2       2         9
H.R. 5789, a bill to require the Secretary of Health
 and Human Services to issue guidance to improve care
 for infants with neonatal abstinence syndrome and
 their mothers, and to require the Comptroller
 General of the United States to conduct a study on
 gaps in Medicaid coverage for pregnant and
 postpartum women with substance use disorder:
    Estimated Authorization Level....................       0       2       0       0       0       0         2
    Estimated Outlays................................       0       2       0       0       0       0         2
H.R. 5795, Overdose Prevention and Patient Safety
 Act:
    Estimated Authorization Level....................       0       1       0       0       0       0         1
    Estimated Outlays................................       0       1       0       0       0       0         1
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
    Estimated Authorization Level....................       0       1       0       0       0       0         1
    Estimated Outlays................................       0       *       *       0       0       0         1
H.R. 5804, Post-Surgical Injections as an Opioid
 Alternative Act:a
    Estimated Authorization Level....................       0       0       0       0       1       1         1
    Estimated Outlays................................       0       0       0       0       1       1         1
H.R. 5811, a bill to amend the Federal Food, Drug,
 and Cosmetic Act with respect to postapproval study
 requirements for certain controlled substances, and
 for other purposes:
    Estimated Authorization Level....................       0       *       *       *       *       *         *
    Estimated Outlays................................       0       *       *       *       *       *         *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).

    H.R. 5009, Jessie's Law, would require HHS, in 
collaboration with outside experts, to develop best practices 
for displaying information about opioid use disorder in a 
patient's medical record. HHS also would be required to develop 
and disseminate written materials annually to health care 
providers about what disclosures could be made while still 
complying with federal laws that govern health care privacy. 
Based on spending patterns for similar activities, CBO 
estimates that implementing H.R. 5009 would have an 
insignificant effect on spending over the 2019-2023 period.
    H.R. 5041, the Safe Disposal of Unused Medication Act, 
would require hospice programs to have written policies and 
procedures for the disposal of controlled substances after a 
patient's death. Certain licensed employees of hospice programs 
would be permitted to assist in the disposal of controlled 
substances that were lawfully dispensed. Using information from 
the Department of Justice (DOJ), CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5272, the Reinforcing Evidence-Based Standards Under 
Law in Treating Substance Abuse Act of 2018, would require the 
newly established National Mental Health and Substance Use 
Policy Laboratory to issue guidance to applicants for SAMHSA 
grants that support evidence-based practices. Using information 
from HHS about the historical cost of similar activities, CBO 
estimates that enacting this bill would cost approximately $4 
million over the 2019-2023 period.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would change the FDA's 
oversight of the commercial marketing of OTC medicines and 
authorize the collection and spending of fees through 2023 to 
cover the costs of expediting the FDA's administrative 
procedures for certain regulatory activities relating to OTC 
products. Under H.R. 5333, CBO estimates, the FDA would assess 
about $147 million in fees over the 2019-2023 period that could 
be collected and made available for obligation only to the 
extent and in the amounts provided in advance in appropriation 
acts. Because the FDA could spend those fees, CBO estimates 
that the estimated budget authority for collections and 
spending would offset each other exactly in each year, although 
CBO expects that spending initially would lag behind 
collections. Assuming appropriation action consistent with the 
bill, CBO estimates that implementing H.R. 5333 would reduce 
net discretionary outlays by $10 million over the 2019-2023 
period, primarily because of that lag. The bill also would 
require the Government Accountability Office to study exclusive 
market protections for certain qualifying OTC drugs authorized 
by the bill--a provision that CBO estimates would cost less 
than $500,000. (If enacted, H.R. 5333 also would affect 
mandatory spending; see Table 1.)
    H.R. 5473, the Better Pain Management Through Better Data 
Act of 2018, would require that the FDA conduct a public 
meeting and issue guidance to industry addressing data 
collection and labeling for medical products that reduce pain 
while enabling the reduction, replacement, or avoidance of oral 
opioids. Using information from the agency, CBO estimates that 
implementing H.R. 5473 would cost about $1 million over the 
2019-2023 period.
    H.R. 5483, the Special Registration for Telemedicine 
Clarification Act of 2018, would direct DOJ, within one year of 
the bill's enactment, to issue regulations concerning the 21 
practice of telemedicine (for remote diagnosis and treatment of 
patients). Using information from DOJ, CBO estimates that 
implementing the bill would cost less than $500,000 over the 
2019-2023 period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would authorize the FDA to collect and 
spend fees to cover the cost of expedited approval for the 
development and marketing of certain drugs for use in animals. 
The legislation would extend through fiscal year 2023, and make 
several changes to, the FDA's existing approval processes and 
fee programs for brand-name and generic veterinary drugs, which 
expire at the end of fiscal year 2018. CBO estimates that 
implementing H.R. 5554 would reduce net discretionary outlays 
by $8 million over the 2019-2023 period, primarily because the 
spending of fees lags somewhat behind their collection.
    Fees authorized under the bill would supplement funds 
appropriated to cover the FDA's cost of reviewing certain 
applications and investigational submissions for brand-name and 
generic drugs for use in animals. Those fees could be collected 
and made available for obligation only to the extent and in the 
amounts provided in advance in appropriation acts. Under H.R. 
5554, CBO estimates, the FDA would assess about $257 million in 
fees over the 2019-2023 period. Because the FDA could spend 
those funds, CBO estimates that budget authority for 
collections and spending would offset each other exactly in 
each year. CBO estimates that the delay between collecting and 
spending fees under the reauthorized programs would reduce net 
discretionary outlays by $14 million over the 2019-2023 period, 
assuming appropriation actions consistent with the bill.
    Enacting H.R. 5554 would increase the FDA's workload 
because the legislation would expand eligibility for 
conditional approval for certain drugs. The agency's 
administrative costs also would increase because of regulatory 
activities required by a provision concerning petitions for 
additives intended for use in animal food. H.R. 5554 also would 
require the FDA to publish guidance or produce regulations on a 
range of topics, transmit a report to the Congress, and hold 
public meetings. CBO expects that the costs associated with 
those activities would not be covered by fees, and it estimates 
that implementing such provisions would cost $6 million over 
the 2019-2023 period.
    H.R. 5582, the Abuse Deterrent Access Act of 2018, would 
require the Secretary of HHS to report to the Congress on 
existing barriers to access to ``abuse-deterrent opioid 
formulations'' by Medicare Part C and D beneficiaries. Such 
formulations make the drugs more difficult to dissolve for 
injection, for example, and thus can impede their abuse. 
Assuming the availability of appropriated funds and based on 
historical spending patterns for similar activities, CBO 
estimates that implementing the legislation would cost less 
than $500,000 over the 2019-2023 period.
    H.R. 5590, the Opioid Addiction Action Plan Act, would 
require the Secretary of HHS to develop an action plan by 
January 1, 2019, for increasing access to medication-assisted 
treatment among Medicare and Medicaid enrollees. The bill also 
would require HHS to convene a stakeholder meeting and issue a 
request for information within three months of enactment, and 
to submit a report to the Congress by June 1, 2019. Based on 
historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5590 would cost approximately 
$2 million over the 2019-2023 period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
FDA to require certain packaging and disposal technologies, 
controls, or measures to mitigate the risk of abuse and misuse 
of drugs. Based on information from the FDA, CBO estimates that 
implementing H.R. 5687 would not significantly affect spending 
over the 2019-2023 period. This bill would also require that 
the GAO study the effectiveness and use of packaging 
technologies for controlled substances--a provision that CBO 
estimates would cost less than $500,000.
    H.R. 5715, the Strengthening Partnerships to Prevent Opioid 
Abuse Act, would require the Secretary of HHS to establish a 
secure Internet portal to allow HHS, Medicare Advantage plans, 
and Medicare Part D plans to exchange information about fraud, 
waste, and abuse among providers and suppliers no later than 
two years after enactment. H.R. 5715 also would require 
organizations with Medicare Advantage contracts to submit 
information on investigations related to providers suspected of 
prescribing large volumes of opioids through a process 
established by the Secretary no later than January 2021. Based 
on historical spending patterns for similar activities, CBO 
estimates that implementing H.R. 5715 would cost approximately 
$9 million over the 2019-2023 period.
    H.R. 5789, a bill to require the Secretary of Health and 
Human Services to issue guidance to improve care for infants 
with neonatal abstinence syndrome and their mothers, and to 
require the Comptroller General of the United States to conduct 
a study on gaps in Medicaid coverage for pregnant and 
postpartum women with substance use disorder, would direct the 
Secretary of HHS to issue guidance to states on best practices 
under Medicaid and CHIP for treating infants with neonatal 
abstinence syndrome. H.R. 5789 also would direct the Government 
Accountability Office to study Medicaid coverage for pregnant 
and postpartum women with substance use disorders. Based on 
information from HHS and historical spending patterns for 
similar activities, CBO estimates that enacting H.R. 5789 would 
cost approximately $2 million over the 2019-2023 period.
    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would amend the Public Health Service Act so that requirements 
pertaining to the confidentiality and disclosure of medical 
records relating to substance use disorders align with the 
provisions of the Health Insurance Portability and 
Accountability Act of 1996. The bill would require the Office 
of the Secretary of HHS to issue regulations prohibiting 
discrimination based on data disclosed from such medical 
records, to issue regulations requiring covered entities to 
provide written notice of privacy practices, and to develop 
model training programs and materials for health care providers 
and patients and their families. Based on spending patterns for 
similar activities, CBO estimates that implementing H.R. 5795 
would cost approximately $1 million over the 2019-2023 period.
    H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct 
the Medicaid and CHIP Payment and Access Commission to study 
institutions for mental diseases in a representative sample of 
states. Based on information from the commission about the cost 
of similar work, CBO estimates that implementing H.R. 5800 
would cost about $1 million over the 2019-2023 period.
    H.R. 5804, the Post-Surgical Injections as an Opioid 
Alternative ACt, would freeze the Medicare payment rate for 
certain analgesic injections provided in ambulatory surgical 
centers. The bill also would mandate two studies of Medicare 
coding and payments arising from enactment of this legislation. 
Based on the cost of similar activities, CBO estimates that 
those reports would cost $1 million over the 2019-2023 period. 
(If enacted, H.R. 5804 also would affect mandatory spending; 
see Table 1.)
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would allow the FDA to require that pharmaceutical 
manufacturers study certain drugs after they are approved to 
assess any potential reduction in those drugs' effectiveness 
for the conditions of use prescribed, recommended, or suggested 
in labeling. CBO anticipates that implementing H.R. 5811 would 
not significantly affect the FDA's costs over the 2019-2023 
period.
    Other Authorizations. The following nine bills would 
increase authorization levels, but CBO has not completed 
estimates of amounts. All authorizations would be subject to 
future appropriation action.
           H.R. 4284, Indexing Narcotics, Fentanyl, and 
        Opioids Act of 2017
           H.R. 5002, Advancing Cutting Edge Research 
        Act
           H.R. 5228, Stop Counterfeit Drugs by 
        Regulating and Enhancing Enforcement Now Act (see Table 
        1 for an estimate of the revenue effects of H.R. 5228)
           H.R. 5752, Stop Illicit Drug Importation Act 
        of 2018 (see Table 1 for an estimate of the revenue 
        effects of H.R. 5752)
           H.R. 5799, Medicaid DRUG Improvement Act 
        (see Table 1 for an estimate of the direct spending 
        effects of H.R. 5799)
           H.R. 5801, Medicaid Providers and 
        Pharmacists Are Required to Note Experiences in Record 
        Systems to Help In-Need Patients (PARTNERSHIP) Act (see 
        Table 1 for an estimate of the direct spending effects 
        of H.R. 5801)
           H.R. 5806, 21st Century Tools for Pain and 
        Addiction Treatments Act
           H.R. 5808, Medicaid Pharmaceutical Home Act 
        of 2018 (see Table 1 for an estimate of the direct 
        spending effects of H.R. 5808)
           H.R. 5812, Creating Opportunities that 
        Necessitate New and Enhanced Connections That Improve 
        Opioid Navigation Strategies Act (CONNECTIONS) Act
    Pay-As-You-Go considerations: The Statutory Pay-As-You-Go 
Act of 2010 establishes budget-reporting and enforcement 
procedures for legislation affecting direct spending or 
revenues. Twenty-two of the bills discussed in this document 
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending 
and revenues in those bills can be found in Table 1.
    Increase in long-term direct spending and deficits: CBO 
estimates that enacting H.R. 4998, the Health Insurance for 
Former Foster Youth Act, would increase net direct spending by 
more than $2.5 billion and on-budget deficits by more than $5 
billion in at least one of the four consecutive 10-year periods 
beginning in 2029.
    CBO estimates that none of the remaining 58 bills included 
in this estimate would increase net direct spending by more 
than $2.5 billion or on-budget deficits by more than $5 billion 
in any of the four consecutive 10-year periods beginning in 
2029.
    Mandates: One of the 59 bills included in this document, 
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the 
costs of that bill's mandates on public and private entities 
would fall below UMRA's thresholds ($80 million and $160 
million, respectively, for public- and private-sector entities 
in 2018, adjusted annually for inflation).
    In addition, five bills would impose private-sector 
mandates as defined in UMRA. CBO estimates that the costs of 
the mandates in three of those bills (H.R. 5333, H.R. 5554, and 
H.R. 5811) would fall below the UMRA threshold. Because CBO 
does not know how federal agencies would implement new 
authority granted in the other two of those five bills, H.R. 
5228 and 5687, CBO cannot determine whether the costs of their 
mandates would exceed the threshold.
    For large entitlement grant programs, including Medicaid 
and CHIP, UMRA defines an increase in the stringency of 
conditions on states or localities as an intergovernmental 
mandate if the affected governments lack authority to offset 
those costs while continuing to provide required services. 
Because states possess significant flexibility to alter their 
responsibilities within Medicaid and CHIP, the requirements 
imposed by various bills in the markup on state administration 
of those programs would not constitute mandates as defined in 
UMRA.

Mandates Affecting Public and Private Entities

    H.R. 5795, the Overdose Prevention and Patient Safety Act, 
would impose intergovernmental and private-sector mandates by 
requiring entities that provide treatment for substance use 
disorders to notify patients of their privacy rights and also 
to notify patients in the event that the confidentiality of 
their records is breached. In certain circumstances, H.R. 5795 
also would prohibit public and private entities from denying 
entry to treatment on the basis of information in patient 
health records. Those requirements would either supplant or 
narrowly expand responsibilities under existing law, and 
compliance with them would not impose significant additional 
costs. CBO estimates that the costs of the mandates would fall 
below the annual thresholds established in UMRA.

Mandates Affecting Private Entities

    Five bills included in this document would impose private-
sector mandates:
    H.R. 5228, the Stop Counterfeit Drugs by Regulating and 
Enhancing Enforcement Now Act, would require drug distributors 
to cease distributing any drug that the Secretary of HHS 
determines might present an imminent or substantial hazard to 
public health. CBO cannot determine what drugs could be subject 
to such an order nor can it determine how private entities 
would respond. Consequently, CBO cannot determine whether the 
aggregate cost of the mandate would exceed the annual threshold 
for private-sector mandates.
    H.R. 5333, the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, would require developers 
and manufacturers of OTC drugs to pay certain fees to the FDA. 
CBO estimates that about $30 million would be collected each 
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual 
threshold for private-sector mandates in any year during that 
period.
    H.R. 5554, the Animal Drug and Animal Generic Drug User Fee 
Amendments of 2018, would require developers and manufacturers 
of brand-name and generic veterinary drugs to pay application, 
product, establishment, and sponsor fees to the FDA. CBO 
estimates that about $51 million would be collected annually, 
on average, for a total of $257 million over the 2019-2023 
period. Those amounts would not exceed the annual threshold for 
private-sector mandates in any year during that period.
    H.R. 5687, the Securing Opioids and Unused Narcotics with 
Deliberate Disposal and Packaging Act of 2018, would permit the 
Secretary of HHS to require drug developers and manufacturers 
to implement new packaging and disposal technology for certain 
drugs. Based on information from the agency, CBO expects that 
the Secretary would use the new regulatory authority provided 
in the bill; however, it is uncertain how or when those 
requirements would be implemented. Consequently, CBO cannot 
determine whether the aggregate cost of the mandate would 
exceed the annual threshold for private entities.
    H.R. 5811, a bill to amend the Federal Food, Drug, and 
Cosmetic Act with respect to postapproval study requirements 
for certain controlled substances, and for other purposes, 
would expand an existing mandate that requires drug developers 
to conduct postapproval studies or clinical trials for certain 
drugs. Under current law, in certain instances, the FDA can 
require studies or clinical trials after a drug has been 
approved. H.R. 5811 would permit the FDA to use that authority 
if the reduction in a drug's effectiveness meant that its 
benefits no longer outweighed its costs. CBO estimates that the 
incremental cost of the mandate would fall below the annual 
threshold established in UMRA because of the small number of 
drugs affected and the narrow expansion of the authority that 
exists under current law.
    None of the remaining 53 bills included in this document 
would impose an intergovernmental or private-sector mandate.

Previous CBO Estimate

    On June 6, 2018, CBO issued an estimate for seven opioid-
related bills ordered reported by the House Committee on Ways 
and Means on May 16, 2018. Two of those bills contain 
provisions that are identical or similar to the legislation 
ordered reported by the Committee on Energy and Commerce, and 
for those provisions, CBO's estimates are the same.
    In particular, five bills listed in this estimate contain 
provisions that are identical or similar to those in several 
sections of H.R. 5773, the Preventing Addiction for Susceptible 
Seniors Act of 2018:
           H.R. 5675, which would require prescription 
        drug plans to implement drug management programs, is 
        identical to section 2 of H.R. 5773.
           H.R. 4841, regarding electronic prior 
        authorization for prescriptions under Medicare's Part 
        D, is similar to section 3 of H.R. 5773.
           H.R. 5715, which would mandate the creation 
        of a new Internet portal to allow various stakeholders 
        to exchange information, is identical to section 4 of 
        H.R. 5773.
           H.R. 5684, which would expand medication 
        therapy management, is the same as section 5 of H.R. 
        5773.
           H.R. 5716, regarding prescriber 
        notification, is identical to section 6 of H.R. 5773.
    In addition, in this estimate, a provision related to 
Medicare beneficiary education in H.R. 5686, the Medicare Clear 
Health Options in Care for Enrollees Act of 2018, is the same 
as a provision in section 2 of H.R. 5775, the Providing 
Reliable Options for Patients and Educational Resources Act of 
2018, in CBO's estimate for the Committee on Ways and Means.
    Estimate prepared by: Federal Costs: Rebecca Yip (Centers 
for Disease Control and Prevention), Mark Grabowicz (Drug 
Enforcement Agency), Julia Christensen, Ellen Werble (Food and 
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health 
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee, 
Rebecca Yip (Medicare), Philippa Haven (National Institutes of 
Health), Alice Burns, Andrea Noda (Office of the Secretary of 
the Department of Health and Human Services), Philippa Haven, 
Lori Housman, Emily King (Substance Abuse and Mental Health 
Services Administration, Health Resources and Services 
Administration); Federal Revenues: Jacob Fabian, Peter Huether, 
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate 
Kelly; Mandates: Andrew Laughlin.
    Estimate reviewed by: Tom Bradley, Chief, Health Systems 
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates 
Unit; Sarah Masi, Special Assistant for Health; Susan Willie, 
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for 
Budget Analysis; Theresa A. Gullo, Assistant Director for 
Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to change 
the FDA's oversight of the commercial marketing of OTC 
medicines and authorize the collection and spending of fees 
through 2023 to cover the costs of expediting the FDA's 
administrative procedures for certain regulatory activities 
relating to OTC products.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 5333 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 5333 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                  Disclosure of Directed Rule Makings

    Pursuant to section 3(i) of H. Res. 5, the Committee finds 
that H.R. 5333 contains no directed rule makings.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    The section provides that the Act may be cited as the 
``Over-the-Counter Monograph Safety, Innovation, and Reform Act 
of 2018.''

                        TITLE I--OTC DRUG REVIEW

Section 101. Regulation of certain nonprescription drugs marketed 
        without an approved new drug application

    Section 101 clarifies how nonprescription drugs marketed 
without a new drug application (NDA) as of the date of 
enactment shall be treated. Drugs that are in conformity with a 
final monograph will be deemed to be generally recognized as 
safe and effective (GRASE), and not a new drug and not subject 
to NDA requirements. Drugs that are in conformity with a 
tentative final monograph will be deemed to be GRASE and not a 
new drug and not subject to NDA requirements, unless such drug 
falls under an administrative order regarding dosage form 
changes, is in a dosage form that has been used to a material 
time and extent, complies with a future final administrative 
order from FDA, or otherwise meets one of the preceding 
requirements and follows a minor change of procedure. Drugs 
that are classified as Category III and in conformity with a 
tentative final monograph or Category I and in conformity with 
the conditions proposed in an advanced notice of proposed rule-
making may be legally marketed without a NDA. Drugs classified 
in Category II for safety and effectiveness under a tentative 
final monograph or that is subject to a determination not to be 
safe or effective in a proposed rule shall be deemed to be a 
new drug, misbranded, and subjected to the NDA requirements 180 
days after enactment unless the Secretary determines it is in 
the interest of public health to extend such period.
    Sunscreen drugs will be GRASE if they conform with a stayed 
final monograph, except that testing conditions governing 
labeling will be those contained in a separate, existing 
requirement.
    Section 101 also transitions the OTC monograph regulatory 
process from a rule-making process to an administrative order 
process. Administrative orders may be initiated by the 
Secretary or by requestors. Such administrative orders will 
specify conditions under which specific drugs, classes of 
drugs, or combinations of drugs will be subject to a NDA and 
GRASE. Administrative orders initiated by the Secretary must be 
published on the web site of the FDA and include the reasons 
for such order. Sponsors should be notified no later than two 
business days before issuance of the proposed orders, and a 
public comment period of not less than 45 calendar days shall 
be provided. After such comment period, the Secretary will 
provide a detailed statement of reasons supporting the issuance 
of a final administrative order. The order will not take effect 
until the time for requesting judicial review has expired. If 
the Secretary is initiating a proposed administrative order 
determining that a drug is not GRASE, the Secretary shall 
provide the general categories of data supporting such 
determination, the format for submissions by interested 
persons, and a comment period of 180 days (with a good cause 
exception for a shorter comment period). Final or tentative 
final monographs for Category I drugs are deemed final 
administrative orders.
    The section also specifies a hearing procedure to address 
concerns with the final administrative order. If a sponsor 
objects to an administrative order, they must first pursue 
dispute resolution within FDA's Center for Drug Evaluation and 
Research (CDER) within 45 days. If there is still a dispute 
after that process, the sponsor may pursue a FDA hearing, which 
must be requested within 30 days after the CDER dispute 
process. CDER may deny a hearing if the hearing request and 
administrative record do not establish a genuine and 
substantial question of material fact based on data using 
relevant and reliable scientific principles and methodologies. 
FDA may consolidate hearing requests. The presiding officer for 
the hearing will be designated by the Secretary, may not be an 
employee of CDER, and may not have been involved in the 
development of the administrative order. Parties to the hearing 
will have a right to present testimony, including experts, and 
to cross-examine witnesses presented by other parties. Judicial 
appeals will go to a U.S. District Court and must be filed 
within 60 days.
    In instances of an imminent hazard to public health, the 
Secretary may issue an interim final administrative order, 
together with a detailed statement of the reasons for the 
order, which would take effect on a specified date. An interim 
final order will include at least a 45-day comment period and 
would substitute for a proposed order. The interim final order 
process will apply to safety labeling changes if the Secretary 
determines that such changes are reasonably expected to 
mitigate a significant or unreasonable risk of a serious 
adverse event associated with the use of a drug. FDA will issue 
a final administrative order and a sponsor may pursue dispute 
resolution and a hearing within 12 months. Judicial appeal may 
follow a final order.
    Requestors may initiate an administrative order process to 
establish or change conditions for a drug to be found GRASE by 
filing a request in a FDA-defined format. FDA will make a 
determination if the request is sufficiently complete and 
formatted to permit a substantive review. Such administrative 
order should be reviewed under the ordinary administrative 
order process described above. A requestor may file under 
protest with certain limitations. Changes to an order, other 
than a change necessary to ensure safety, that provide for a 
drug to contain a new active ingredient or a change in the 
conditions of use of a drug supported by new human data 
essential to the approval of the change, including clinical 
trials of safety or effectiveness, actual use studies, or 
pharmacokinetics or bioavailability studies will be provided 
with an exclusivity period of 18 months from drug listing.
    The Comptroller General of the United States is required to 
conduct a study not later than four years after enactment to 
consider the effectiveness and overall impact of exclusivity 
under this section. The study shall include the number of drugs 
granted and exclusivity and the indication for which the drug 
was determined to be GRASE; whether the exclusivity was for a 
drug with a new active ingredient of changes in the conditions 
of use; whether and to what extent the exclusivity impacted the 
requestor's decision to develop the drug; an analysis of the 
implementation of the exclusivity provision, including the 
resources used by FDA, the impact on innovation and research 
and development, the impact on competition, the impact on 
consumer access, the impact on nonprescription drug prices, and 
whether the requestor-initiated order process has been 
sufficient to encourage the development of nonprescription 
drugs that would likely not be otherwise developed or developed 
in as timely a manner; and whether the requestor-initiated 
order process has been sufficient to encourage innovation in 
the nonprescription drug market.
    Requests filed to establish a drug not currently in a 
monograph is GRASE must include information sufficient for a 
threshold determination that the drug has been marketed and 
safely used by consumers in the U.S. under comparable 
conditions of use; information to demonstrate the drug was 
marketed and safely used in a foreign country under conditions 
of use for a reasonable period of time and under a regulatory 
body of a country listed in section 802(b)(1)(A) or a country 
designated by FDA under 802(b)(1)(B); or if FDA determines such 
information is not needed to provide a threshold demonstration 
that the drug can be safely marketed as an OTC drug.
    Administrative orders initiated by the Secretary, 
requestor, or posing an imminent hazard to public health may 
include packaging requirements. Such requirements may include 
unit dose packaging, requirements for products intended for use 
by children, requirements to reduce harm from unsupervised 
ingestion, or other appropriate requirements.
    Minor changes in dosage forms that otherwise are consistent 
with the requirements of a monograph may take place without 
prior notice at a requestor's discretion so long as that 
requestor maintains information on file to demonstrate the 
change will not affect safety or effectiveness and will not 
materially affect absorption or other exposure to the active 
ingredient, and updates drug listing information within 30 days 
after introduction of the drug. Requestors shall submit records 
to the Secretary regarding minor changes within 15 days of such 
request. If the Secretary determines the information in such 
records is not sufficient, the Secretary will inform the 
requestor in writing and provide with reasonable opportunity to 
provide additional information. If the requestor fails to 
provide necessary additional information, the drug as modified 
will be an unapproved new drug and misbranded.
    FDA shall issue administrative orders and guidance about 
whether minor changes made by a requestor 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 by specific dosage forms. FDA will take into 
account relevant public standards and may take into account 
special needs of children in developing these orders and 
guidance.
    Reports of testing related to requestor-initiated 
administrative orders will be kept confidential unless the 
requestor consents to the disclosure. Other information, other 
than raw data sets, submitted in support of the request shall 
be made public on the date of the proposed order unless the 
information is related to pharmaceutical quality. Information 
provided to support a minor change will remain confidential. 
Information submitted in a requestor-initiated process may be 
withdrawn by the requestor before a proposed order under FDA 
procedures.
    Updates for changes to monograph drugs must be submitted to 
FDA's drug listing system within 30 days of introduction or, 
for drugs under a requestor-initiated administrative order, 
prior to introduction into commerce.
    This section does not preclude requestors from seeking new 
drug approval, including under abbreviated new drug 
applications. Determinations that a drug is GRASE constitute 
findings of safety and effectiveness for the purposes of 
section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), so that applicants only need to file information 
needed to support the modification in a section 505(b)(2) 
application.
    FDA will establish a repository of administrative orders, 
including interim final orders, in effect with their complete 
text. FDA will list, at least annually, administrative orders 
in development with FDA's current expectations for issuance 
over a three-year period. FDA will also establish procedures 
allowing requestors the opportunity for private meetings to 
obtain advice on studies and information necessary to support 
submissions, as well as procedures where there are multiple 
sponsors or requestors on an administrative order. Submissions 
will be in electronic format. Except as otherwise provided, FDA 
will continue to use the existing notice and comment rulemaking 
for rules that would apply to OTC drugs in general. Regulations 
related to certain active ingredients in OTC drugs for certain 
uses that are in effect prior to enactment shall be deemed to 
be final. Regulations prior to enactment establishing 
requirements for specific OTC drugs, such as labeling and 
misbranding, are deemed to be final as they apply to the order 
process of this section. FDA may make technical changes to 
regulations that remain in effect to ensure conformity with 
appropriate terminology and cross references. Finally, FDA will 
issue guidance on meeting procedures and principles for 
sponsors or requestors, the format and content of data 
submissions, format of electronic formats, consolidated 
proceedings, and recommendations on how to comply with order 
requirements for on data to be kept on file for minor product 
dosage form changes.
    This section does not affect the current status of a 
nonprescription drug marketed under a NDA or ANDA or that is 
not subject to an administrative order. The Paperwork Reduction 
Act will not apply to information collections under this 
section, and administrative orders will not be subject to 
Administrative Procedure Act rulemaking requirements.
    Definitions for ``nonprescription drug,'' ``sponsor,'' and 
``requestor'' are provided.

Section 102. Misbranding

    Section 102 provides that monograph drugs not in compliance 
or marketed from a non-fee paying facility are misbranded.

Section 103. Drugs excluded from the Over-the-Counter Drug Review

    Section 103 provides that these sections do not apply to 
nonprescription drugs FDA intentionally excluded from the OTC 
Drug Review.

Section 104. Treatment of Sunscreen Innovation Act

    Section 104 provides the sponsor of a proposed sunscreen 
order under the Sunscreen Innovation Act (SIA) may elect to 
remain under the SIA or may notify FDA that the order will 
follow the process under Monograph reform. If in the Monograph 
reform process, it will be deemed an order request accepted for 
filing. Such election shall be made within 180 calendar days of 
enactment. A final sunscreen order under SIA will be deemed a 
final order. Sponsors may request confidential meetings, and 
the Secretary shall convene such meeting within a reasonable 
time period. The Secretary may refuse to grant additional 
meetings if the Secretary determines that additional 
confidential meetings are not reasonably necessary to advance a 
proposed sunscreen order, or if the request fails to include 
sufficient information upon which to base a substantive 
conversation. The Secretary shall publish post-meeting 
summaries. SIA sunsets at the end of fiscal year (FY) 2022.

Section 105. Update to Congress on appropriate pediatric indication for 
        certain OTC cough and cold drugs

    Not later than one year after the date of enactment, and 
annually thereafter, the Secretary must submit a letter to the 
House Committee on Energy and Commerce and the Senate Committee 
on Health, Education, Labor, and Pensions describing HHS' 
progress in evaluating cough and cold monograph drugs for 
children under age six until FDA submits a letter indicating it 
has completed its evaluation and revised, as applicable, the 
cough and cold monograph.

               TITLE II--FEES RELATING TO MONOGRAPH DRUGS

Section 201. Short title; findings

    Section 201 provides that the title may be cited as the 
``Over-the-Counter Monograph User Fee Act of 2018.'' Congress 
finds fees will be dedicated toward the nonprescription 
monograph drug activities under goals identified in letters 
from FDA to the committees of jurisdiction.

Section 202. Authority to access and use fees

    Section 202 provides definitions, including ``OTC monograph 
drug activities,'' ``OTC monograph drug facility,'' ``Contract 
manufacturing organization,'' ``Tier 1 OTC monograph order 
request,'' and ``Tier 2 OTC monograph order request.''
    Section 202 authorizes FDA to assess and use OTC monograph 
fees. Each person that owns a monograph drug facility on 
December 31 or at any time in the preceding year shall be 
assessed a facility fee unless the facility has ceased all 
activities related to monograph drugs and updated its 
registration to reflect such changes. Fees for contract 
manufacturing organization facilities shall be equal to the 
amount that is two-thirds of the fee for an OTC monograph drug 
facility. For FY 2019, facility fees are due 45 days after FDA 
publishes a notice on the fee amount. For fiscal years after 
2019, fees are due on the later of June 1 or the first business 
day after enactment of an appropriations Act providing for 
collection.
    Sponsor-initiated OTC monograph order requests are subject 
to an inflation-adjusted $500,000 fee for Tier 1 requests, and 
$100,000 for Tier 2 requests. Safety-related label change OTC 
monograph order requests are exempt from the fee. Partial 
refunds are possible for withdrawals before filing, before 
substantial work was performed, or in tier reclassifications.
    Before inflation adjustments or operating reserve 
adjustments, target fee collections from facility fees would be 
$22 million for FY 2018, $22 million for FY 2019, $25 million 
for FY 2020, $31 million for FY 2021, and $34 million for FY 
2022.
    An inflation adjustment tied to the Consumer Price Index 
(CPI) and related factors is included for fiscal years 2020-
2023. Carryover of unspent funds or for to cover excess work 
may be held in an operating reserve with a maximum carry-over 
of: three weeks' worth of fees in FY 2019, seven weeks in FY 
2020, and ten weeks in FY 2021-23. Amounts over the maximum 
would result in fee reductions the following year.
    Based on facility assessments through drug registrations as 
of December 31, FDA will set and publish the facility fee for 
that fiscal year by January 31, with fees due before April 1. 
Manufacturers must submit facility information each year 
through drug establishment registration under existing section 
510 of the FFDCA. Nonprescription monograph drug order requests 
submitted by a sponsor or requestor not paying fees will be 
considered incomplete, and ineligible for closed meetings. Fees 
may be collected and available only to the extent provided in 
appropriations Acts and available solely for nonprescription 
monograph drug activities. Before FDA may spend fee revenue, 
FDA must allocate $12 million year, adjusted for inflation. 
Fees paid prior to the due date may be accepted, however, fees 
not received by FDA after a grace period will be treated as a 
U.S. Government claim. Full-time equivalent positions (FTEs) at 
the Department of Health and Human Services not engaged in 
monograph activities may not be construed to require an offset 
from FTEs in monograph activities.
    Starting in 2019, by February 1 of each year, FDA must 
submit to Congress reports on its progress in meeting the goals 
identified in the goals letter and future plans for meeting 
such goals and the status of FDA's implementation of its fee 
authority, fee uses, and collections. Such reports will be 
posted on FDA's website.
    FDA is directed to consult with Congress, scientific 
experts, healthcare professionals, patient and advocacy groups, 
and industry in preparing recommendations for Congress for 
reauthorization beyond FY 2022. FDA must post a recommendations 
report and take comments. FDA's final recommendations will be 
sent to Congress no later than January 15, 2022.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT




           *       *       *       *       *       *       *
                      CHAPTER V--DRUGS AND DEVICES


Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *



                      misbranded drugs and devices

  Sec. 502. A drug or device shall be deemed to be misbranded--
  (a)(1) If its labeling is false or misleading in any 
particular. Health care economic information provided to a 
payor, formulary committee, or other similar entity with 
knowledge and expertise in the area of health care economic 
analysis, carrying out its responsibilities for the selection 
of drugs for coverage or reimbursement, shall not be considered 
to be false or misleading under this paragraph if the health 
care economic information relates to an indication approved 
under section 505 or under section 351(a) of the Public Health 
Service Act for such drug, is based on competent and reliable 
scientific evidence, and includes, where applicable, a 
conspicuous and prominent statement describing any material 
differences between the health care economic information and 
the labeling approved for the drug under section 505 or under 
section 351 of the Public Health Service Act. The requirements 
set forth in section 505(a) or in subsections (a) and (k) of 
section 351 of the Public Health Service Act shall not apply to 
health care economic information provided to such a payor, 
committee, or entity in accordance with this paragraph. 
Information that is relevant to the substantiation of the 
health care economic information presented pursuant to this 
paragraph shall be made available to the Secretary upon 
request.
  (2)(A) For purposes of this paragraph, the term ``health care 
economic information'' means any analysis (including the 
clinical data, inputs, clinical or other assumptions, methods, 
results, and other components underlying or comprising the 
analysis) that identifies, measures, or describes the economic 
consequences, which may be based on the separate or aggregated 
clinical consequences of the represented health outcomes, of 
the use of a drug. Such analysis may be comparative to the use 
of another drug, to another health care intervention, or to no 
intervention.
  (B) Such term does not include any analysis that relates only 
to an indication that is not approved under section 505 or 
under section 351 of the Public Health Service Act for such 
drug.
  (b) If in a package form unless it bears a label containing 
(1) the name and place of business of the manufacturer, packer, 
or distributor; and (2) an accurate statement of the quantity 
of the contents in terms of weight, measure, or numerical 
count: Provided, That under clause (2) of this paragraph 
reasonable variations shall be permitted, and exemptions as to 
small packages shall be established, by regulations prescribed 
by the Secretary.
  (c) If any word, statement, or other information required by 
or under authority of this Act to appear on the label or 
labeling is not prominently placed thereon with such 
conspicuousness (as compared with other words, statements, 
designs, or devices, in the labeling) and in such terms as to 
render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use.
  (e)(1)(A) If it is a drug, unless its label bears, to the 
exclusion of any other nonproprietary name (except the 
applicable systematic chemical name or the chemical formula)--
          (i) the established name (as defined in subparagraph 
        (3)) of the drug, if there is such a name;
          (ii) the established name and quantity or, if 
        determined to be appropriate by the Secretary, the 
        proportion of each active ingredient, including the 
        quantity, kind, and proportion of any alcohol, and also 
        including whether active or not the established name 
        and quantity or if determined to be appropriate by the 
        Secretary, the proportion of any bromides, ether, 
        chloroform, acetanilide, acetophenetidin, amidopyrine, 
        antipyrine, atropine, hyoscine, hyoscyamine, arsenic, 
        digitalis, digitalis glucosides, mercury, ouabain, 
        strophanthin, strychnine, thyroid, or any derivative or 
        preparation of any such substances, contained therein, 
        except that the requirement for stating the quantity of 
        the active ingredients, other than the quantity of 
        those specifically named in this subclause, shall not 
        apply to nonprescription drugs not intended for human 
        use; and
          (iii) the established name of each inactive 
        ingredient listed in alphabetical order on the outside 
        container of the retail package and, if determined to 
        be appropriate by the Secretary, on the immediate 
        container, as prescribed in regulation promulgated by 
        the Secretary, except that nothing in this subclause 
        shall be deemed to require that any trade secret be 
        divulged, and except that the requirements of this 
        subclause with respect to alphabetical order shall 
        apply only to nonprescription drugs that are not also 
        cosmetics and that this subclause shall not apply to 
        nonprescription drugs not intended for human use.
  (B) For any prescription drug the established name of such 
drug or ingredient, as the case may be, on such label (and on 
any labeling on which a name for such drug or ingredient is 
used) shall be printed prominently and in type at least half as 
large as that used thereon for any proprietary name or 
designation for such drug or ingredient, except that to the 
extent that compliance with the requirements of subclause (ii) 
or (iii) of clause (A) or this clause is impracticable, 
exemptions shall be established by regulations promulgated by 
the Secretary.
  (2) If it is a device and it has an established name, unless 
its label bears, to the exclusion of any other nonproprietary 
name, its established name (as defined in subparagraph (4)) 
prominently printed in type at least half as large as that used 
thereon for any proprietary name or designation for such 
device, except that to the extent compliance with the 
requirements of this subparagraph is impracticable, exemptions 
shall be established by regulations promulgated by the 
Secretary.
  (3) As used in subparagraph (1), the term ``established 
name'', with respect to a drug or ingredient thereof, means (A) 
the applicable official name designated pursuant to section 
508, or (B) if there is no such name and such drug, or such 
ingredient, is an article recognized in an official compendium, 
then the official title thereof in such compendium, or (C) if 
neither clause (A) nor clause (B) of this subparagraph applies, 
then the common or usual name, if any, of such drug or of such 
ingredient, except that where clause (B) of this subparagraph 
applies to an article recognized in the United States 
Pharmacopeia and in the Homeopathic Pharmacopeia under 
different official titles, the official title used in the 
United States Pharmacopeia shall apply unless it is labeled and 
offered for sale as a homeopathic drug, in which case the 
official title used in the Homeopathic Pharmacopeia shall 
apply.
  (4) As used in subparagraph (2), the term ``established 
name'' with respect to a device means (A) the applicable 
official name of the device designated pursuant to section 508, 
(B) if there is no such name and such device is an article 
recognized in an official compendium, then the official title 
thereof in such compendium, or (C) if neither clause (A) nor 
clause (B) of this subparagraph applies, then any common or 
usual name of such device.
  (f) Unless its labeling bears (1) adequate directions for 
use; and (2) such adequate warnings against use in those 
pathological conditions or by children where its use may be 
dangerous to health, or against unsafe dosage or methods or 
duration of administration or application, in such manner and 
form, as are necessary for the protection of users, except that 
where any requirement of clause (1) of this paragraph, as 
applied to any drug or device, is not necessary for the 
protection of the public health, the Secretary shall promulgate 
regulations exempting such drug or device from such 
requirement. Required labeling for prescription devices 
intended for use in health care facilities or by a health care 
professional and required labeling for in vitro diagnostic 
devices intended for use by health care professionals or in 
blood establishments may be made available solely by electronic 
means, provided that the labeling complies with all applicable 
requirements of law, and that the manufacturer affords such 
users the opportunity to request the labeling in paper form, 
and after such request, promptly provides the requested 
information without additional cost.
  (g) If it purports to be a drug the name of which is 
recognized in an official compendium, unless it is packaged and 
labeled as prescribed therein. The method of packing may be 
modified with the consent of the Secretary. Whenever a drug is 
recognized in both the United States Pharmacopeia and the 
Homeopathic Pharmacopeia of the United States, it shall be 
subject to the requirements of the United States Pharmacopeia 
with respect to packaging, and labeling unless it is labeled 
and offered for sale as a homeopathic drug, in which case it 
shall be subject to the provisions of the Homeopathic 
Pharmacopeia of the United States, and not to those of the 
United States Pharmacopeia, except that in the event of 
inconsistency between the requirements of this paragraph and 
those of paragraph (e) as to the name by which the drug or its 
ingredients shall be designated, the requirements of paragraph 
(e) shall prevail.
  (h) If it has been found by the Secretary to be a drug liable 
to deterioration, unless it is packaged in such form and 
manner, and its label bears a statement of such precautions, as 
the Secretary shall by regulations require as necessary for the 
protection of the public health. No such regulation shall be 
established for any drug recognized in an official compendium 
until the Secretary shall have informed the appropriate body 
charged with the revision of such compendium of the need for 
such packaging or labeling requirements and such body shall 
have failed within a reasonable time to prescribe such 
requirements.
  (i)(1) If it is a drug and its container is so made, formed, 
or filled as to be misleading; or (2) if it is an imitation of 
another drug; or (3) if it is offered for sale under the name 
of another drug.
  (j) If it is dangerous to health when used in the dosage or 
manner; or with the frequency or duration prescribed, 
recommended, or suggested in the labeling thereof.
  (m) If it is a color additive the intended use of which is 
for the purpose of coloring only, unless its packaging and 
labeling are in conformity with such packaging and labeling 
requirements applicable to such color additive, as may be 
contained in regulations issued under section 721.
  (n) In the case of any prescription drug distributed or 
offered for sale in any State, unless the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to that drug 
a true statement of (1) the established name as defined in 
section 502(e), printed prominently and in type at least half 
as large as that used for any trade or brand name thereof, (2) 
the formula showing quantitatively each ingredient of such drug 
to the extent required for labels under section 502(e), and (3) 
such other information in brief summary relating to side 
effects, contraindications, and effectiveness as shall be 
required in regulations which shall be issued by the Secretary 
in accordance with section 701(a), and in the case of published 
direct-to-consumer advertisements the following statement 
printed in conspicuous text: ``You are encouraged to report 
negative side effects of prescription drugs to the FDA. Visit 
www.fda.gov/medwatch, or call 1-800-FDA-1088.'', except that 
(A) except in extraordinary circumstances, no regulation issued 
under this paragraph shall require prior approval by the 
Secretary of the content of any advertisement, and (B) no 
advertisement of a prescription drug, published after the 
effective date of regulations issued under this paragraph 
applicable to advertisements of prescription drugs, shall, with 
respect to the matters specified in this paragraph or covered 
by such regulations, be subject to the provisions of sections 
12 through 17 of the Federal Trade Commission Act, as amended 
(15 U.S.C. 52-57). This paragraph (n) shall not be applicable 
to any printed matter which the Secretary determines to be 
labeling as defined in section 201(m) of this Act. Nothing in 
the Convention on Psychotropic Substances, signed at Vienna, 
Austria, on February 21, 1971, shall be construed to prevent 
drug price communications to consumers. In the case of an 
advertisement for a drug subject to section 503(b)(1) presented 
directly to consumers in television or radio format and stating 
the name of the drug and its conditions of use, the major 
statement relating to side effects and contraindications shall 
be presented in a clear, conspicuous, and neutral manner.
  (o) If it was manufactured, prepared, propagated, compounded, 
or processed in an establishment not duly registered under 
section 510, if it is a drug and was imported or offered for 
import by a commercial importer of drugs not duly registered 
under section 801(s), if it was not included in a list required 
by section 510(j), if a notice or other information respecting 
it was not provided as required by such section or section 
510(k), or if it does not bear such symbols from the uniform 
system for identification of devices prescribed under section 
510(e) as the Secretary by regulation requires.
  (p) If it is a drug and its packaging or labeling is in 
violation of an applicable regulation issued pursuant to 
section 3 or 4 of the Poison Prevention Packaging Act of 1970.
  (q) In the case of any restricted device distributed or 
offered for sale in any State, if (1) its advertising is false 
or misleading in any particular, or (2) it is sold, 
distributed, or used in violation of regulations prescribed 
under section 520(e).
  (r) In the case of any restricted device distributed or 
offered for sale in any State, unless the manufacturer, packer, 
or distributor thereof includes in all advertisements and other 
descriptive printed matter issued or caused to be issued by the 
manufacturer, packer, or distributor with respect to that 
device (1) a true statement of the device's established name as 
defined in section 502(e), printed prominently and in type at 
least half as large as that used for any trade or brand name 
thereof, and (2) a brief statement of the intended uses of the 
device and relevant warnings, precautions, side effects, and 
contraindications and, in the case of specific devices made 
subject to a finding by the Secretary after notice and 
opportunity for comment that such action is necessary to 
protect the public health, a full description of the components 
of such device or the formula showing quantitatively each 
ingredient of such device to the extent required in regulations 
which shall be issued by the Secretary after an opportunity for 
a hearing. Except in extraordinary circumstances, no regulation 
issued under this paragraph shall require prior approval by the 
Secretary of the content of any advertisement and no 
advertisement of a restricted device, published after the 
effective date of this paragraph shall, with respect to the 
matters specified in this paragraph or covered by regulations 
issued hereunder, be subject to the provisions of sections 12 
through 15 of the Federal Trade Commission Act (15 U.S.C. 52-
55). This paragraph shall not be applicable to any printed 
matter which the Secretary determines to be labeling as defined 
in section 201(m).
  (s) If it is a device subject to a performance standard 
established under section 514, unless it bears such labeling as 
may be prescribed in such performance standard.
  (t) If it is a device and there was a failure or refusal (1) 
to comply with any requirement prescribed under section 518 
respecting the device, (2) to furnish any material or 
information required by or under section 519 respecting the 
device, or (3) to comply with a requirement under section 522.
  (u)(1) Subject to paragraph (2), if it is a reprocessed 
single-use device, unless it, or an attachment thereto, 
prominently and conspicuously bears the name of the 
manufacturer of the reprocessed device, a generally recognized 
abbreviation of such name, or a unique and generally recognized 
symbol identifying such manufacturer.
  (2) If the original device or an attachment thereto does not 
prominently and conspicuously bear the name of the manufacturer 
of the original device, a generally recognized abbreviation of 
such name, or a unique and generally recognized symbol 
identifying such manufacturer, a reprocessed device may satisfy 
the requirements of paragraph (1) through the use of a 
detachable label on the packaging that identifies the 
manufacturer and is intended to be affixed to the medical 
record of a patient.
  (v) If it is a reprocessed single-use device, unless all 
labeling of the device prominently and conspicuously bears the 
statement ``Reprocessed device for single use. Reprocessed by 
__.'' The name of the manufacturer of the reprocessed device 
shall be placed in the space identifying the person responsible 
for reprocessing.
  (w) If it is a new animal drug--
          (1) that is conditionally approved under section 571 
        and its labeling does not conform with the approved 
        application or section 571(f), or that is not 
        conditionally approved under section 571 and its label 
        bears the statement set forth in section 571(f)(1)(A); 
        or
          (2) that is indexed under section 572 and its 
        labeling does not conform with the index listing under 
        section 572(e) or 572(h), or that has not been indexed 
        under section 572 and its label bears the statement set 
        forth in section 572(h).
  (x) If it is a nonprescription drug (as defined in section 
760) that is marketed in the United States, unless the label of 
such drug includes a domestic address or domestic phone number 
through which the responsible person (as described in section 
760) may receive a report of a serious adverse event (as 
defined in section 760) with such drug.
  (y) If it is a drug subject to an approved risk evaluation 
and mitigation strategy pursuant to section 505(p) and the 
responsible person (as such term is used in section 505-1) 
fails to comply with a requirement of such strategy provided 
for under subsection (d), (e), or (f) of section 505-1.
  (z) If it is a drug, and the responsible person (as such term 
is used in section 505(o)) is in violation of a requirement 
established under paragraph (3) (relating to postmarket studies 
and clinical trials) or paragraph (4) (relating to labeling) of 
section 505(o) with respect to such drug.
  (aa) If it is a drug, or an active pharmaceutical ingredient, 
and it was manufactured, prepared, propagated, compounded, or 
processed in a facility for which fees have not been paid as 
required by section 744B(a)(4) or for which identifying 
information required by section 744B(f) has not been submitted, 
or it contains an active pharmaceutical ingredient that was 
manufactured, prepared, propagated, compounded, or processed in 
such a facility.
  (bb) If the advertising or promotion of a compounded drug is 
false or misleading in any particular.
  (cc) If it is a drug and it fails to bear the product 
identifier as required by section 582.
  (dd) If it is an antimicrobial drug, as defined in section 
511A(f), and its labeling fails to conform with the 
requirements under section 511A(d).
  (ee) If it is a nonprescription drug that is subject to 
section 505G, 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 and it was manufactured, prepared, 
propagated, compounded, or processed in a facility for which 
fees have not been paid as required by section 744O.

           *       *       *       *       *       *       *


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

  (a) Nonprescription Drugs Marketed Without an Approved 
Application.--Nonprescription drugs marketed without an 
approved new drug application under section 505, as of the date 
of the enactment of the Over-the-Counter Monograph Safety, 
Innovation, and Reform Act of 2018, shall be treated in 
accordance with this subsection.
          (1) Drugs subject to a final monograph; category i 
        drugs subject to a tentative final monograph.--A drug 
        is deemed to be generally recognized as safe and 
        effective within the meaning of section 201(p)(1), not 
        a new drug under section 201(p), and not subject to 
        section 503(b)(1), if--
                  (A) the drug is--
                          (i) in conformity with the 
                        requirements for nonprescription use of 
                        a final monograph issued under part 330 
                        of title 21, Code of Federal 
                        Regulations (except as provided in 
                        paragraph (2)), the general 
                        requirements for nonprescription drugs, 
                        and requirements under subsections (b), 
                        (c), and (k); and
                          (ii) except as permitted by an order 
                        issued under subsection (b) or, in the 
                        case of a minor change in the drug, in 
                        conformity with an order issued under 
                        subsection (c), in a dosage form that, 
                        immediately prior to the date of the 
                        enactment of this section, has been 
                        used to a material extent and for a 
                        material time within the meaning of 
                        section 201(p)(2); or
                  (B) the drug is--
                          (i) classified in category I for 
                        safety and effectiveness under a 
                        tentative final monograph that is the 
                        most recently applicable proposal or 
                        determination issued under part 330 of 
                        title 21, Code of Federal Regulations;
                          (ii) in conformity with the proposed 
                        requirements for nonprescription use of 
                        such tentative final monograph, any 
                        applicable subsequent determination by 
                        the Secretary, the general requirements 
                        for nonprescription drugs, and 
                        requirements under subsections (b), 
                        (c), and (k); and
                          (iii) except as permitted by an order 
                        issued under subsection (b) or, in the 
                        case of a minor change in the drug, in 
                        conformity with an order issued under 
                        subsection (c), in a dosage form that, 
                        immediately prior to the date of the 
                        enactment of this section, has been 
                        used to a material extent and for a 
                        material time within the meaning of 
                        section 201(p)(2).
          (2) Treatment of sunscreen drugs.--With respect to 
        sunscreen drugs subject to this section, the applicable 
        requirements shall be the requirements specified in 
        part 352 of title 21, Code of Federal Regulations, as 
        published on May 21, 1999, beginning on page 27687 of 
        volume 64 of the Federal Register, except that the 
        applicable requirements governing effectiveness and 
        labeling shall be those specified in section 201.327 of 
        title 21, Code of Federal Regulations, subject to the 
        requirements of subsections (b), (c), and (k).
          (3) Category iii drugs subject to a tentative final 
        monograph; category i drugs subject to proposed 
        monograph or advance notice of proposed rulemaking.--A 
        drug that is not described in paragraphs (1), (2), or 
        (4) is not required to be the subject of an application 
        approved under section 505, and is not subject to 
        section 503(b)(1), if--
                  (A) the drug is--
                          (i) classified in category III for 
                        safety or effectiveness in the preamble 
                        of a proposed rule establishing a 
                        tentative final monograph that is the 
                        most recently applicable proposal or 
                        determination for such drug issued 
                        under part 330 of title 21, Code of 
                        Federal Regulations;
                          (ii) in conformity with--
                                  (I) the conditions of use, 
                                including indication and dosage 
                                strength, if any, described for 
                                such category III drug in such 
                                preamble or in an applicable 
                                subsequent proposed rule;
                                  (II) the proposed 
                                requirements for drugs 
                                classified in such tentative 
                                final monograph in category I 
                                in the most recently proposed 
                                rule establishing requirements 
                                related to such tentative final 
                                monograph and in any final rule 
                                establishing requirements that 
                                are applicable to the drug; and
                                  (III) the general 
                                requirements for 
                                nonprescription drugs and 
                                requirements under subsections 
                                (b) or (k); and
                          (iii) in a dosage form that, 
                        immediately prior to the date of the 
                        enactment of this section, was not 
                        required to have satisfied the 
                        requirements of section 330.14 of title 
                        21, Code of Federal Regulations (as in 
                        effect at that time), in order for such 
                        drug to be lawfully marketed without an 
                        application approved under section 505; 
                        or
                  (B) the drug is--
                          (i) classified in category I for 
                        safety and effectiveness under a 
                        proposed monograph or advance notice of 
                        proposed rulemaking that is the most 
                        recently applicable proposal or 
                        determination for such drug issued 
                        under part 330 of title 21, Code of 
                        Federal Regulations;
                          (ii) in conformity with the 
                        requirements for nonprescription use of 
                        such proposed monograph or advance 
                        notice of proposed rulemaking, any 
                        applicable subsequent determination by 
                        the Secretary, the general requirements 
                        for nonprescription drugs, and 
                        requirements under subsections (b) or 
                        (k); and
                          (iii) in a dosage form that, 
                        immediately prior to the date of the 
                        enactment of this section, has been 
                        used to a material extent and for a 
                        material time within the meaning of 
                        section 201(p)(2).
          (4) Category ii drugs deemed new drugs.--A drug that 
        is classified in category II for safety or 
        effectiveness under a tentative final monograph or that 
        is subject to a determination to be not safe or 
        effective in a proposed rule that is the most recently 
        applicable proposal issued under part 330 of title 21, 
        Code of Federal Regulations, shall be deemed to be a 
        new drug within the meaning of section 201(p), 
        misbranded under section 502(ee), and subject to the 
        requirement for an approved new drug application under 
        section 505 beginning on the day that is 180 calendar 
        days after the date of the enactment of this section, 
        unless, before such day, the Secretary determines that 
        it is in the interest of public health to extend the 
        period during which the drug may be marketed without 
        such an approved new drug application.
          (5) Drugs not grase deemed new drugs.--A drug that 
        the Secretary has determined not to be generally 
        recognized as safe and effective within the meaning of 
        section 201(p)(1) under a final determination issued 
        under part 330 of title 21, Code of Federal 
        Regulations, shall be deemed to be a new drug within 
        the meaning of section 201(p), misbranded under section 
        502(ee), and subject to the requirement for an approved 
        new drug application under section 505.
          (6) Other drugs deemed new drugs.--Except as provided 
        in subsection (m), a drug is deemed to be a new drug 
        within the meaning of section 201(p) and misbranded 
        under section 502(ee) if the drug--
                  (A) is not subject to section 503(b)(1); and
                  (B) is not described in paragraphs (1), (2), 
                (3), (4), or (5), or subsection (b)(1)(B).
  (b) Administrative Orders.--
          (1) In general.--
                  (A) Determination.--The Secretary may, on the 
                initiative of the Secretary or at the request 
                of one or more requestors, issue administrative 
                orders determining whether there are conditions 
                under which specific drugs, classes of such 
                drugs, or combinations of such drugs are 
                determined to be--
                          (i) not subject to section 503(b)(1); 
                        and
                          (ii) generally recognized as safe and 
                        effective within the meaning of section 
                        201(p)(1).
                  (B) Effect.--A drug or combination of drugs 
                shall be deemed to not require approval under 
                section 505 if such drug or combination of 
                drugs--
                          (i) is determined by the Secretary to 
                        meet the conditions specified in 
                        clauses (i) and (ii) of subparagraph 
                        (A);
                          (ii) is marketed in conformity with 
                        an administrative order under this 
                        subsection;
                          (iii) meets the general requirements 
                        for nonprescription drugs; and
                          (iv) meets the requirements under 
                        subsections (c) and (k).
                  (C) Standard.--The Secretary shall find that 
                a drug is not generally recognized as safe and 
                effective within the meaning of section 
                201(p)(1) if--
                          (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.--
                  (A) In general.--In issuing an administrative 
                order under paragraph (1) upon the Secretary's 
                initiative, the Secretary shall--
                          (i) make reasonable efforts to notify 
                        informally, not later than 2 business 
                        days before the issuance of the 
                        proposed order, the sponsors of drugs 
                        who have a listing in effect under 
                        section 510(j) for the drugs or 
                        combination of drugs that will be 
                        subject to the administrative order;
                          (ii) after any such reasonable 
                        efforts of notification--
                                  (I) issue a proposed 
                                administrative order by 
                                publishing it on the website of 
                                the Food and Drug 
                                Administration and include in 
                                such order the reasons for the 
                                issuance of such order; and
                                  (II) publish a 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 completion of the 
                        proceedings specified in 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, which order shall not 
                                take effect until the time for 
                                requesting judicial review 
                                under paragraph (3)(D)(ii) has 
                                expired;
                                  (II) publish a notice of such 
                                final administrative order in 
                                the Federal Register;
                                  (III) afford requestors of 
                                drugs 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 
                                must 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 persons 
                                which sought such dispute 
                                resolution of their right to 
                                request a hearing.
                  (B) Exceptions.--When issuing an 
                administrative order under paragraph (1) on the 
                Secretary's initiative proposing to determine 
                that a drug described in subsection (a)(3) 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 no 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 
                        interests 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).
          (3) Hearings; judicial review.--
                  (A) In general.--Only a person who 
                participated in each stage of formal dispute 
                resolution under subclause (III) of paragraph 
                (2)(A)(iv) of an administrative order with 
                respect to a drug may request a hearing 
                concerning a final administrative order issued 
                under such paragraph with respect to such drug. 
                Such person must submit a request for a 
                hearing, which shall be based solely on 
                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.--
                          (i) In general.--The Secretary shall 
                        not be 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 (a)(3)(A); and
                                  (II) with respect to which no 
                                human or non-human data studies 
                                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.
                          (ii) Human data studies and non-human 
                        data defined.--In this subparagraph:
                                  (I) The term ``human data 
                                studies'' means clinical trials 
                                of safety or effectiveness 
                                (including actual use studies), 
                                pharmacokinetics studies, or 
                                bioavailability studies.
                                  (II) The term ``non-human 
                                data'' means data from testing 
                                other than with human subjects 
                                which provides information 
                                concerning safety or 
                                effectiveness.
                  (C) Hearing procedures.--
                          (i) Denial of request for hearing.--
                        If the Secretary determines that 
                        information submitted in a request for 
                        a hearing under subparagraph (A) with 
                        respect to a final administrative order 
                        issued under paragraph (2)(A)(iv), does 
                        not identify 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 
                        presiding officer of a hearing 
                        requested under subparagraph (A) 
                        shall--
                                  (I) be designated by the 
                                Secretary;
                                  (II) not be an employee of 
                                the Center for Drug Evaluation 
                                and Research; and
                                  (III) not have been 
                                previously involved in the 
                                development of the 
                                administrative order involved 
                                or 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.--
                                  (I) 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.
                                  (II) 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) Period 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 such request for 
                        judicial 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 a 
                                hearing with respect to such 
                                order is denied under 
                                subparagraph (B) or (C)(i);
                                  (III) the date on which a 
                                final decision is made 
                                following a hearing 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 
                        drug, class of drugs, or combination of 
                        drugs subject to this section poses an 
                        imminent hazard to the public health, 
                        the Secretary, after first making 
                        reasonable efforts to notify, not later 
                        than 48 hours before issuance of such 
                        order under this subparagraph, sponsors 
                        who have a listing in effect under 
                        section 510(j) for such drug or 
                        combination of drugs--
                                  (I) may issue an interim 
                                final administrative order for 
                                such drug, class of drugs, or 
                                combination of drugs under 
                                paragraph (1), together with a 
                                detailed statement of the 
                                reasons for such order;
                                  (II) shall publish in the 
                                Federal Register a notice of 
                                availability of any such order; 
                                and
                                  (III) shall provide for a 
                                public comment period of at 
                                least 45 calendar days with 
                                respect to 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) make reasonable efforts 
                                to notify informally, not later 
                                than 48 hours before the 
                                issuance of the interim final 
                                order, the sponsors of drugs 
                                who have a listing in effect 
                                under section 510(j) for such 
                                drug or combination of drugs;
                                  (II) after reasonable efforts 
                                of notification, 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;
                                  (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 with respect to 
                                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 such 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 must 
                        initially 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.--A sponsor of a drug subject to 
                a final order issued under subparagraph (D) and 
                that participated in each stage of formal 
                dispute resolution under clause (iii) of such 
                subparagraph may request a hearing on such 
                order. The provisions of subparagraphs (A), 
                (B), and (C) of paragraph (3), other than 
                paragraph (3)(C)(v)(II), 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).
                  (F) Timing.--
                          (i) Final order and hearing.--The 
                        Secretary shall--
                                  (I) not later than 6 months 
                                after the date on which the 
                                comment period closes under 
                                subparagraph (A) or (B), issue 
                                a final order in accordance 
                                with paragraph (1); and
                                  (II) not later than 12 months 
                                after the date on which such 
                                final order is issued, complete 
                                any hearing under subparagraph 
                                (E).
                          (ii) Dispute resolution request.--The 
                        Secretary shall specify in an interim 
                        final order issued under subparagraph 
                        (A) or (B) such shorter periods for 
                        requesting dispute resolution under 
                        subparagraph (D)(iii) as are necessary 
                        to meet the requirements of this 
                        subparagraph.
                  (G) Judicial review.--A final order issued 
                pursuant to subparagraph (F) shall be subject 
                to judicial review in accordance with paragraph 
                (3)(D).
          (5) Administrative order initiated at the request of 
        a requestor.--
                  (A) In general.--In issuing an administrative 
                order under paragraph (1) at the request of a 
                requestor 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) 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 paragraph 
                        (6), if the Secretary determines that a 
                        request does not meet the requirements 
                        for filing or is not sufficiently 
                        complete and formatted to permit a 
                        substantive review, the requestor may 
                        demand that the request be filed 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 under paragraph 
                        (1) 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 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, absent such a changed 
                                condition of use, such drug 
                                is--
                                          (aa) generally 
                                        recognized as safe and 
                                        effective within the 
                                        meaning of section 
                                        201(p)(1) in accordance 
                                        with subsection (a)(1), 
                                        (a)(2), or an order 
                                        under this subsection; 
                                        or
                                          (bb) subject to 
                                        subsection (a)(3), 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).
                          (ii) Exception.--The Secretary is not 
                        required to complete review of a 
                        request for a change described in 
                        clause (i)(II) if the Secretary 
                        determines that there is an inadequate 
                        basis to find the drug is generally 
                        recognized as safe and effective within 
                        the meaning of section 201(p)(1) under 
                        paragraph (1) and issues a final order 
                        announcing that determination.
                          (iii) Withdrawal.--The requestor may 
                        withdraw a request under this 
                        paragraph, according to the procedures 
                        set forth pursuant to subsection 
                        (d)(2)(B). Notwithstanding any other 
                        provision of this section, if such 
                        request is withdrawn, the Secretary may 
                        cease proceedings under this 
                        subparagraph.
                  (C) Exclusivity.--
                          (i) In general.--A final 
                        administrative order issued in response 
                        to a request under this section 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), for a period of 
                        18 months following the effective date 
                        of such final order, to market drugs--
                                  (I) incorporating changes 
                                described in clause (ii);
                                  (II) beginning on the date 
                                the requestor (or any such 
                                licensees, assignees, or 
                                successors in interest) may 
                                lawfully market such drugs 
                                pursuant to the order; and
                                  (III) 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 subsection 
                                (a)(1), (a)(2), or (a)(3);
                                  (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 
                                (m)(1), other than drugs 
                                subject to an active 
                                enforcement action under 
                                chapter III of this Act.
                          (iv) Limitations on exclusivity.--
                                  (I) In general.--Only one 
                                period of exclusivity shall be 
                                granted, under each order 
                                described in clause (i), with 
                                respect to changes (to the drug 
                                subject to such order) which 
                                are either--
                                          (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) No exclusivity 
                                allowed.--No exclusivity shall 
                                apply to changes to a drug 
                                which are--
                                          (aa) the subject of a 
                                        Tier 2 OTC monograph 
                                        order request (as 
                                        defined in section 
                                        744N);
                                          (bb) safety-related 
                                        changes, as defined by 
                                        the Secretary, or any 
                                        other changes the 
                                        Secretary considers 
                                        necessary to assure 
                                        safe use; or
                                          (cc) changes related 
                                        to methods of testing 
                                        safety or efficacy.
                          (v) New human data studies defined.--
                        In this subparagraph, the term ``new 
                        human data studies'' means clinical 
                        trials of safety or effectiveness 
                        (including actual use studies), 
                        pharmacokinetics studies, or 
                        bioavailability studies, the results of 
                        which--
                                  (I) have not been relied on 
                                by the Secretary 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 that was approved 
                                        under section 505; and
                                  (II) do not duplicate the 
                                results of another study that 
                                was relied on by the Secretary 
                                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 that was approved 
                                        under section 505.
                          (vi) Effective date.--A final order 
                        subject to clause (i) shall take effect 
                        on the date when the order requestor 
                        (or the licensees, assignees, or 
                        successors in interest of such 
                        requestor with respect to such order) 
                        submits updated drug listing 
                        information under subsection (e) with 
                        respect to the change which is 
                        permitted under such order.
                          (vii) GAO study.--Not later than 4 
                        years after the date of enactment of 
                        the Over-the-Counter Monograph, Safety, 
                        Innovation, and Reform Act of 2018, the 
                        Comptroller General of the United 
                        States shall submit a study to the 
                        Committee on Energy and Commerce of the 
                        House of Representatives and the 
                        Committee on Health, Education, Labor, 
                        and Pensions of the Senate addressing 
                        the effectiveness and overall impact of 
                        exclusivity under this section, 
                        including its impact on consumer 
                        access. Such study shall include--
                                  (I) the number of 
                                nonprescription drug products 
                                that were granted exclusivity 
                                and the indication for which 
                                the nonprescription drug 
                                products were determined to be 
                                generally recognized as safe 
                                and effective;
                                  (II) whether the exclusivity 
                                for such drug products was 
                                granted for--
                                          (aa) a new active 
                                        ingredient (including 
                                        any ester or salt of 
                                        the active ingredient); 
                                        or
                                          (bb) changes in the 
                                        conditions of use of a 
                                        drug, for which new 
                                        human data studies 
                                        conducted or sponsored 
                                        by the requestor were 
                                        essential;
                                  (III) whether, and to what 
                                extent, the exclusivity 
                                impacted the requestor's or 
                                sponsor's decision to develop 
                                the drug product;
                                  (IV) an analysis of the 
                                implementation of the 
                                exclusivity provision in this 
                                subparagraph, including--
                                          (aa) the resources 
                                        used by the Food and 
                                        Drug Administration;
                                          (bb) the impact of 
                                        such provision on 
                                        innovation, as well as 
                                        research and 
                                        development in the 
                                        nonprescription drug 
                                        market;
                                          (cc) the impact of 
                                        such provision on 
                                        competition in the 
                                        nonprescription drug 
                                        market;
                                          (dd) the impact of 
                                        such provision on 
                                        consumer access to 
                                        nonprescription drug 
                                        products;
                                          (ee) the impact of 
                                        such provision on the 
                                        prices of 
                                        nonprescription drug 
                                        products; and
                                          (ff) whether the 
                                        administrative orders 
                                        initiated by requestors 
                                        under this section have 
                                        been sufficient to 
                                        encourage the 
                                        development of 
                                        nonprescription drug 
                                        products that would 
                                        likely not be otherwise 
                                        developed, or developed 
                                        in as timely a manner; 
                                        and
                                  (V) whether the 
                                administrative orders initiated 
                                by requestors under this 
                                section have been sufficient 
                                incentive to encourage 
                                innovation in the 
                                nonprescription drug market.
          (6) Information regarding safe nonprescription 
        marketing and use as condition for filing a generally 
        recognized as safe and effective request.--
                  (A) In general.--In response to a request 
                under this section that a drug described in 
                subparagraph (B) be generally recognized as 
                safe and effective, the Secretary--
                          (i) may file such request, if the 
                        request includes information specified 
                        under subparagraph (C) with respect to 
                        safe nonprescription marketing and use 
                        of such drug; or
                          (ii) if the request fails to include 
                        information specified under 
                        subparagraph (C), shall refuse to file 
                        such request and require that 
                        nonprescription marketing of the drug 
                        be pursuant to a new drug application 
                        as described in subparagraph (D).
                  (B) Drug described.--A drug described in this 
                subparagraph is a nonprescription drug which 
                contains an active ingredient not previously 
                incorporated in a drug--
                          (i) specified in subsection (a)(1), 
                        (a)(2), or (a)(3);
                          (ii) subject to a final order under 
                        this section; or
                          (iii) subject to a final sunscreen 
                        order (as defined in section 
                        586(2)(A)).
                  (C) Information demonstrating prima facie 
                safe nonprescription marketing and use.--
                Information specified in this subparagraph, 
                with respect to a request described in 
                subparagraph (A)(i), is--
                          (i) information sufficient for a 
                        prima facie 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 prima 
                        facie demonstration that the drug was 
                        marketed and safely used under 
                        comparable conditions of marketing and 
                        use in a country listed in section 
                        802(b)(1)(A) or designated by the 
                        Secretary in accordance with section 
                        802(b)(1)(B)--
                                  (I) for such period of time 
                                as needed to provide reasonable 
                                assurances concerning the safe 
                                nonprescription use of the 
                                drug; and
                                  (II) during such time was 
                                subject to sufficient 
                                monitoring by a regulatory body 
                                considered acceptable by the 
                                Secretary for such monitoring 
                                purposes, including for adverse 
                                events associated with 
                                nonprescription use of the 
                                drug; or
                          (iii) if the Secretary determines 
                        that information described in clauses 
                        (i) or (ii) is not needed to provide a 
                        prima facie demonstration that the drug 
                        can be safely marketed and used as a 
                        nonprescription drug, such other 
                        information the Secretary determines is 
                        sufficient for such purposes.
                  (D) Marketing pursuant to new drug 
                application.--In the case of a request 
                described in subparagraph (A)(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 conditions 
                        specified in the request, for such 
                        period of time as the Secretary 
                        determines appropriate (not to exceed 
                        five consecutive years) pursuant to an 
                        application approved under section 505; 
                        and
                          (ii) during such time period, one 
                        million retail packages of the drug, or 
                        an equivalent quantity as determined by 
                        the Secretary, were distributed for 
                        retail sale, as determined in such 
                        manner as the Secretary finds 
                        appropriate.
                  (E) Rule of application.--Except in the case 
                of a request involving a drug described in 
                section 586(9), as in effect on January 1, 
                2017, if the Secretary refuses to file a 
                request under this paragraph, the requestor may 
                not file such request over protest under 
                paragraph (5)(A)(iii).
          (7) Packaging.--An administrative order issued under 
        paragraph (2), (4)(A), or (5) may include requirements 
        for the packaging of a drug to encourage use in 
        accordance with labeling. Such requirements may include 
        unit dose packaging, requirements for products intended 
        for use by children, requirements to reduce risk of 
        harm from unsupervised ingestion, and other appropriate 
        requirements. This paragraph does not authorize the 
        Food and Drug Administration to require standards or 
        testing procedures as described in part 1700 of title 
        16, Code of Federal Regulations.
          (8) Final and tentative final monographs for category 
        i drugs deemed final administrative orders.--
                  (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 is described in this 
                subparagraph if it--
                          (i) establishes conditions of use for 
                        a drug described in paragraph (1) or 
                        (2) of subsection (a); and
                          (ii) represents the most recently 
                        promulgated version of such conditions, 
                        including as modified, in whole or in 
                        part, by any proposed or final rule.
                  (C) Deemed orders include harmonizing 
                technical amendments.--The deemed establishment 
                of a final administrative order under 
                subparagraph (A) shall be construed to include 
                any technical amendments to such order as the 
                Secretary determines necessary to ensure that 
                such order is appropriately harmonized, in 
                terms of terminology or cross-references, with 
                the applicable provisions of this Act (and 
                regulations thereunder) and any other orders 
                issued under this section.
  (c) Procedure for Minor Changes.--
          (1) In general.--Minor changes in the dosage form of 
        a drug that is described in paragraph (1) or (2) of 
        subsection (a) or the subject of an order issued under 
        subsection (b) may be made by a requestor without the 
        issuance of an order under subsection (b) if--
                  (A) the requestor maintains such information 
                as is 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; and
                  (B) 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.--A sponsor shall 
                submit records requested by the Secretary 
                relating to such a minor change under section 
                704(a)(4), within 15 business days of receiving 
                such a 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 sponsor of the 
                        drug in writing; and
                          (ii) provide the sponsor of the drug 
                        with a reasonable opportunity to 
                        provide additional information.
                  (C) Failure to submit sufficient 
                information.--If the sponsor 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 a change will affect safety 
        or effectiveness.--
                  (A) In general.--The Secretary shall issue 
                one or more administrative orders specifying 
                requirements for determining whether a minor 
                change made by a sponsor 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.--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 drugs, 
                and may take into account the special needs of 
                populations, including children.
  (d) Confidentiality of Information Submitted to the 
Secretary.--
          (1) In general.--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 order 
        under this section (including any minor change under 
        subsection (c)) 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.--
                  (A) In general.--Except as provided in 
                subparagraph (B), the Secretary shall--
                          (i) make any information submitted by 
                        a requestor in support of a request 
                        under subsection (b)(5)(A) available to 
                        the public not later than the date on 
                        which the proposed order is issued; and
                          (ii) make any information submitted 
                        by any other person with respect to an 
                        order requested (or initiated by the 
                        Secretary) under subsection (b), 
                        available to the public upon such 
                        submission.
                  (B) Limitations on public availability.--
                Information described in subparagraph (A) shall 
                not be made public if--
                          (i) the information pertains to 
                        pharmaceutical quality information, 
                        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);
                          (ii) the information is submitted in 
                        a requestor-initiated request, but the 
                        requestor withdraws such request, in 
                        accordance with withdrawal procedures 
                        established by the Secretary, before 
                        the Secretary issues the proposed 
                        order;
                          (iii) the Secretary requests and 
                        obtains the information under 
                        subsection (c) and such information is 
                        not submitted in relation to an order 
                        under subsection (b); or
                          (iv) the information is of the type 
                        contained in raw datasets.
  (e) 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 
section 510(j) within 30 calendar days of the date when the 
drug is first commercially marketed, except that a sponsor who 
was the order requestor with respect to an order subject to 
subsection (b)(5)(C) (or a licensee, assignee, or successor in 
interest of such requestor) shall submit updated drug listing 
information on or before the date when the drug is first 
commercially marketed.
  (f) Approvals Under Section 505.--The provisions of this 
section shall not be construed to preclude a person from 
seeking or maintaining the approval of a drug under sections 
505(b)(1), 505(b)(2), and 505(j). 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 that the drug is safe and 
effective that may be relied upon for purposes of an 
application under section 505(b)(2), so that the applicant 
shall be required to submit for purposes of such application 
only information needed to support any modification of the drug 
that is not covered by such determination under this section.
  (g) Public Availability of Administrative Orders.--The 
Secretary shall establish, maintain, update (as determined 
necessary by the Secretary but no less frequently than 
annually), and make publicly available, with respect to orders 
issued under this section--
          (1) a repository of each final order and interim 
        final order in effect, including the complete text of 
        the order; and
          (2) a listing of all orders proposed and under 
        development under subsection (b)(2), including--
                  (A) a brief description of each such order; 
                and
                  (B) the Secretary's expectations, if 
                resources permit, for issuance of proposed 
                orders over a three-year period.
  (h) Development Advice to Sponsors or Requestors.--The 
Secretary shall establish procedures under which sponsors or 
requestors may meet with appropriate officials of the Food and 
Drug Administration to obtain advice on the studies and other 
information necessary to support submissions under this section 
and other matters relevant to the regulation of nonprescription 
drugs and the development of new nonprescription drugs under 
this section.
  (i) Participation of Multiple Sponsors or Requestors.--The 
Secretary shall establish procedures to facilitate efficient 
participation by multiple sponsors or requestors in proceedings 
under this section, including provision for joint meetings with 
multiple sponsors or requestors or with organizations nominated 
by sponsors or requestors to represent their interests in a 
proceeding.
  (j) Electronic Format.--All submissions under this section 
shall be in electronic format.
  (k) 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) The provisions of section 310.545 of 
                title 21, Code of Federal Regulations, as in 
                effect on the day before the date of the 
                enactment of this section, shall be deemed to 
                be a final order under subsection (b).
                  (B) Regulations in effect on the day before 
                the date of the enactment of this section, 
                establishing requirements for specific 
                nonprescription drugs marketed pursuant to this 
                section (including such requirements in parts 
                201 and 250 of title 21, Code of Federal 
                Regulations), shall be deemed to be final 
                orders under subsection (b), only as they apply 
                to drugs--
                          (i) subject to paragraph (1), (2), 
                        (3), or (4) of subsection (a); or
                          (ii) otherwise subject to an order 
                        under this section.
          (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 the enactment of this section), 
        or make technical changes to such regulations to ensure 
        conformity with appropriate terminology and cross 
        references. Notwithstanding subchapter II of chapter 5 
        of title 5, United States Code, any such withdrawal or 
        technical changes shall be made without public notice 
        and comment and shall be effective upon publication 
        through notice in the Federal Register (or upon such 
        date as specified in such notice).
  (l) Guidance.--The Secretary shall issue guidance that 
specifies--
          (1) the procedures and principles for formal meetings 
        between the Secretary and sponsors or requestors for 
        drugs subject to this section;
          (2) the format and content of data submissions to the 
        Secretary under this section;
          (3) the format of electronic submissions to the 
        Secretary under this section;
          (4) consolidated proceedings and the procedures for 
        such proceedings where appropriate; and
          (5) for minor changes in drugs, recommendations on 
        how to comply with the requirements in orders issued 
        under subsection (c)(3).
  (m) Rule of Construction.--
          (1) In general.--This section shall not affect the 
        treatment or status of a nonprescription drug--
                  (A) that is marketed without an application 
                approved under section 505 as of the date of 
                the enactment of this section;
                  (B) that is not subject to an order issued 
                under this section; and
                  (C) to which paragraphs (1), (2), (3), (4), 
                or (5) of subsection (a) do not apply.
          (2) Treatment of products previously found to be 
        subject to time and extent requirements.--
                  (A) Notwithstanding subsection (a), a drug 
                described in subparagraph (B) may only be 
                lawfully marketed, without an application 
                approved under section 505, pursuant to an 
                order issued under this section.
                  (B) A drug described in this subparagraph is 
                a drug which, prior to the date of the 
                enactment of this section, the Secretary had 
                determined in a proposed or final rule to be 
                ineligible for review under the OTC drug review 
                (as such phrase ``OTC drug review'' was used in 
                section 330.14 of title 21, Code of Federal 
                Regulations, as in effect on the day before the 
                date of the enactment of this section).
          (3) Preservation of authority.--
                  (A) Nothing in paragraph (1) shall be 
                construed to preclude or limit the 
                applicability of any other provision of this 
                Act.
                  (B) Nothing in subsection (a) 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 within the meaning of section 
                201(p)(1), as the Secretary determines 
                appropriate.
  (n) Investigational New Drugs.--A drug is not subject to this 
section if an exemption for investigational use under section 
505(i) is in effect for such drug.
  (o) Inapplicability of Paperwork Reduction Act.--Chapter 35 
of title 44, United States Code, shall not apply to collections 
of information made under this section.
  (p) Inapplicability of Notice and Comment Rulemaking and 
Other Requirements.--The requirements of subsection (b) shall 
apply with respect to orders issued under this section instead 
of the requirements of subchapter II of chapter 5 of title 5, 
United States Code.
  (q) Definitions.--In this section:
          (1) The term ``nonprescription drug'' refers to a 
        drug not subject to the requirements of section 
        503(b)(1).
          (2) The term ``sponsor'' refers to any person 
        marketing, manufacturing, or processing a drug that--
                  (A) is listed pursuant to section 510(j); and
                  (B) is or will be subject to an 
                administrative order of the Food and Drug 
                Administration.
          (3) The term ``requestor'' refers to any person or 
        group of persons marketing, manufacturing, processing, 
        or developing a drug.

           *       *       *       *       *       *       *


Subchapter I--Nonprescription Sunscreen and Other Active Ingredients

           *       *       *       *       *       *       *


SEC. 586C. GRASE DETERMINATION.

  (a) Review of New Request.--
          (1) Proposed sunscreen order.--In the case of a 
        request under section 586A, not later than 300 calendar 
        days after the date on which such request is filed 
        under subsection (b)(2)(A) or (b)(3)(B)(ii)(III) of 
        section 586B, the Secretary--
                  (A) may convene a meeting of the Advisory 
                Committee to review such request; and
                  (B) shall complete the review of such request 
                and issue a proposed sunscreen order with 
                respect to such request.
          (2) Proposed sunscreen order by commissioner.--If the 
        Secretary does not issue a proposed sunscreen order 
        under paragraph (1)(B) within such 300-day period, the 
        sponsor of such request may notify the Office of the 
        Commissioner of such request and request review by the 
        Office of the Commissioner. If such sponsor so notifies 
        the Office of the Commissioner, the Commissioner shall, 
        not later than 60 calendar days after the date of 
        notification under this paragraph, issue a proposed 
        sunscreen order with respect to such request.
          (3) Public comment period.--A proposed sunscreen 
        order issued under paragraph (1)(B) or (2) with respect 
        to a request shall provide for a period of 45 calendar 
        days for public comment.
          (4) Meeting.--A sponsor may request, in writing, a 
        meeting with respect to a proposed sunscreen order 
        issued under this subsection and described in 
        subparagraph (B) or (C) of section 586(7), not later 
        than 30 calendar days after the Secretary issues such 
        order. The Secretary shall convene a meeting with such 
        sponsor not later than 45 calendar days after such 
        request for a meeting.
          (5) Final sunscreen order.--With respect to a 
        proposed sunscreen order under paragraph (1)(B) or 
        (2)--
                  (A) the Secretary shall issue a final 
                sunscreen order--
                          (i) in the case of a proposed 
                        sunscreen order described in 
                        subparagraph (A) or (B) of section 
                        586(7), not later than 90 calendar days 
                        after the end of the public comment 
                        period under paragraph (3); or
                          (ii) in the case of a proposed 
                        sunscreen order described in 
                        subparagraph (C) of section 586(7), not 
                        later than 210 calendar days after the 
                        date on which the sponsor submits the 
                        additional information requested 
                        pursuant to such proposed sunscreen 
                        order; or
                  (B) if the Secretary does not issue such 
                final sunscreen order within such 90- or 210-
                calendar-day period, as applicable, the sponsor 
                of such request may notify the Office of the 
                Commissioner of such request and request review 
                by the Office of the Commissioner.
          (6) Final sunscreen order by commissioner.--The 
        Commissioner shall issue a final sunscreen order with 
        respect to a proposed sunscreen order subject to 
        paragraph (5)(B) not later than 60 calendar days after 
        the date of notification under such paragraph.
  (b) Review of Pending Requests.--
          (1) In general.--The review of a pending request 
        shall be carried out by the Secretary in accordance 
        with this subsection.
          (2) Inapplicability of sections 586a and 586b.--
        Sections 586A and 586B shall not apply with respect to 
        any pending request.
          (3) Feedback letters as proposed sunscreen order.--
        Notwithstanding the requirements of section 586(7), a 
        letter issued pursuant to section 330.14(g) of title 
        21, Code of Federal Regulations before the date of 
        enactment of the Sunscreen Innovation Act, with respect 
        to a pending request, shall be deemed to be a proposed 
        sunscreen order and displayed on the Internet website 
        of the Food and Drug Administration. Notification of 
        the availability of such letter shall be published in 
        the Federal Register not later than 45 calendar days 
        after the date of enactment of such Act.
          (4) Proposed sunscreen order.--In the case of a 
        pending request for which the Secretary has not issued 
        a letter pursuant to section 330.14(g) of title 21, 
        Code of Federal Regulations before the date of 
        enactment of the Sunscreen Innovation Act, the 
        Secretary shall complete review of such request and, 
        not later than 90 calendar days after the date of 
        enactment of such Act, issue a proposed sunscreen order 
        with respect to such request.
          (5) Proposed sunscreen order by commissioner.--If the 
        Secretary does not issue a proposed sunscreen order 
        under paragraph (4), or the Secretary does not publish 
        a notification of the availability of a letter under 
        paragraph (3), as applicable, the sponsor of such 
        request may notify the Office of the Commissioner of 
        such request and request review by the Office of the 
        Commissioner. The Commissioner shall, not later than 60 
        calendar days after the date of notification under this 
        paragraph, issue a proposed order with respect to such 
        request.
          (6) Public comment period.--A proposed sunscreen 
        order issued under paragraph (4) or (5), or a 
        notification of the availability of a letter under 
        paragraph (3), with respect to a pending request shall 
        provide for a period of 45 calendar days for public 
        comment.
          (7) Meeting.--[A sponsor may request]
                  (A) In general._A sponsor may request, in 
                writing, a meeting with respect to a proposed 
                sunscreen order issued under this subsection, 
                including a letter deemed to be a proposed 
                sunscreen order under paragraph (3), not later 
                than 30 calendar days after the Secretary 
                issues such order or the date upon which such 
                feedback letter is deemed to be a proposed 
                sunscreen order, as applicable. The Secretary 
                shall convene a meeting with such sponsor not 
                later than 45 calendar days after the date of 
                such request for a meeting.
                  (B) Confidential meetings.--A sponsor may 
                request one or more confidential meetings with 
                respect to a proposed sunscreen order, 
                including a letter deemed to be a proposed 
                sunscreen order under paragraph (3), to discuss 
                matters involving confidential commercial 
                information or trade secrets. The Secretary 
                shall convene a confidential meeting with such 
                sponsor in a reasonable time period. If a 
                sponsor requests more than one confidential 
                meeting for the same proposed sunscreen order, 
                the Secretary may refuse to grant an additional 
                confidential meeting request if the Secretary 
                determines that such additional confidential 
                meeting is not reasonably necessary for the 
                sponsor to advance its proposed sunscreen 
                order, or if the request for a confidential 
                meeting fails to include sufficient information 
                upon which to base a substantive discussion. 
                The Secretary shall publish a post-meeting 
                summary of each confidential meeting under this 
                subparagraph that does not disclose 
                confidential commercial information or trade 
                secrets.
          (8) Advisory committee.--In the case of a proposed 
        sunscreen order under paragraph (3), (4), or (5), an 
        Advisory Committee meeting may be convened for the 
        purpose of reviewing and providing recommendations 
        regarding the pending request.
          (9) Final sunscreen order.--In the case of a proposed 
        sunscreen order under paragraph (3), (4), or (5)--
                  (A) the Secretary shall issue a final 
                sunscreen order with respect to the request--
                          (i) in the case of a proposed 
                        sunscreen order described in 
                        subparagraph (A) or (B) of section 
                        586(7), not later than 90 calendar days 
                        after the end of the public comment 
                        period under paragraph (6); or
                          (ii) in the case of a proposed 
                        sunscreen order described in 
                        subparagraph (C) of section 586(7)--
                                  (I) if the Advisory Committee 
                                is not convened under paragraph 
                                (8), not later than 210 
                                calendar days after the date on 
                                which the sponsor submits the 
                                additional information 
                                requested pursuant to such 
                                proposed sunscreen order, which 
                                shall include a rationale for 
                                not convening such Advisory 
                                Committee; or
                                  (II) if the Advisory 
                                Committee is convened under 
                                paragraph (8), not later than 
                                270 calendar days after the 
                                date on which the sponsor 
                                submits such additional 
                                information; or
                  (B) if the Secretary does not issue such 
                final sunscreen order within such 90-, 210-, or 
                270-calendar-day period, as applicable, the 
                sponsor of such request may notify the Office 
                of the Commissioner about such request and 
                request review by the Office of the 
                Commissioner.
          (10) Final sunscreen order by commissioner.--The 
        Commissioner shall issue a final sunscreen order with 
        respect to a proposed sunscreen order subject to 
        paragraph (9)(B) not later than 60 calendar days after 
        the date of notification under such paragraph.
  (c) Advisory Committee.--The Secretary shall not be required 
to--
          (1) convene the Advisory Committee--
                  (A) more than once with respect to any 
                request under section 586A or any pending 
                request; or
                  (B) more than twice in any calendar year with 
                respect to the review under this section; or
          (2) submit more than a total of 3 requests under 
        section 586A or pending requests to the Advisory 
        Committee per meeting.
  (d) No Delegation.--Any responsibility vested in the 
Commissioner by subsection (a)(2), (a)(6), (b)(5), or (b)(10) 
shall not be delegated.
  (e) Effect of Final Sunscreen Order.--
          (1) In general.--
                  (A) Sunscreen active ingredients determined 
                to be grase.--Upon issuance of a final 
                sunscreen order determining that a 
                nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients is GRASE and is not misbranded, a 
                sunscreen containing such ingredient or 
                combination of ingredients shall be permitted 
                to be introduced or delivered into interstate 
                commerce for use under the conditions described 
                in such final sunscreen order, in accordance 
                with all requirements applicable to drugs not 
                subject to section 503(b)(1), for so long as 
                such final sunscreen order remains in effect.
                  (B) Sunscreen active ingredients determined 
                not to be grase.--Upon issuance of a final 
                sunscreen order determining that a 
                nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients is not GRASE and is misbranded, a 
                sunscreen containing such ingredient or 
                combination of ingredients shall not be 
                introduced or delivered into interstate 
                commerce, for use under the conditions 
                described in such final sunscreen order, unless 
                an application is approved pursuant to section 
                505 with respect to a sunscreen containing such 
                ingredient or combination of ingredients, or 
                unless conditions are later established under 
                which such ingredient or combination of 
                ingredients is later determined to be GRASE and 
                not misbranded under the over-the-counter drug 
                monograph system.
          (2) Amendments to final sunscreen orders.--
                  (A) Amendments at initiative of secretary.--
                In the event that information relevant to a 
                nonprescription sunscreen active ingredient or 
                combination of nonprescription sunscreen active 
                ingredients becomes available to the Secretary 
                after issuance of a final sunscreen order, the 
                Secretary may amend such final sunscreen order 
                by issuing a new proposed sunscreen order under 
                subsection (a)(1) and following the procedures 
                set forth in this section.
                  (B) Petition to amend final order.--Any 
                interested person may petition the Secretary to 
                amend a final sunscreen order under section 
                10.30, title 21 Code of Federal Regulations (or 
                any successor regulations). If the Secretary 
                grants any petition under such section, the 
                Secretary shall initiate the process for 
                amending a final sunscreen order by issuing a 
                new proposed sunscreen order under subsection 
                (a)(1) and following the procedures set forth 
                in this section.
                  (C) Applicability of final orders.--Once the 
                Secretary issues a new proposed sunscreen order 
                to amend a final sunscreen order under 
                subparagraph (A) or (B), such final sunscreen 
                order shall remain in effect and paragraph (3) 
                shall not apply to such final sunscreen order 
                until the Secretary has issued a new final 
                sunscreen order or has determined not to amend 
                the final sunscreen order.
          [(3) Inclusion of ingredients that are subjects of 
        final orders in the sunscreen monograph.--
                  [(A) Amending regulations.--
                          [(i) Requirement.--At any time that 
                        the Secretary proposes to amend part 
                        352 of title 21, Code of Federal 
                        Regulations (or any successor 
                        regulations) concerning nonprescription 
                        sunscreen, including pursuant to 
                        section 586E, except as provided in 
                        clause (iv), the Secretary shall 
                        include in such part 352 (or any 
                        successor regulations) any 
                        nonprescription sunscreen active 
                        ingredient or combination of 
                        nonprescription sunscreen active 
                        ingredients that is the subject of an 
                        effective final sunscreen order of the 
                        type described in section 586(2)(A) and 
                        issued since the time that the 
                        Secretary last amended such 
                        regulations. Such regulation shall set 
                        forth conditions of use under which 
                        each such ingredient or combination of 
                        ingredients is GRASE and not 
                        misbranded. If these conditions differ 
                        from, or are in addition to, those 
                        previously set forth in the applicable 
                        final sunscreen order, the Secretary 
                        shall provide notice and opportunity 
                        for comment on such conditions in the 
                        rulemaking, and the applicable final 
                        sunscreen order shall continue in 
                        effect until the effective date of a 
                        final regulation, as set forth in 
                        clause (iii).
                          [(ii) Inclusion of orders.--In 
                        proposing to amend the regulations as 
                        described in clause (i), the Secretary 
                        shall include in the proposed 
                        regulations a list of final sunscreen 
                        orders that shall cease to be effective 
                        on the effective date of a resulting 
                        final regulation. Such list shall 
                        include all final sunscreen orders of 
                        the type described in section 586(2)(A) 
                        that are in effect on the date that 
                        such regulations are proposed, with the 
                        exception that such list shall not 
                        include any final sunscreen orders 
                        that, on the date that the regulations 
                        are proposed, the Secretary is in the 
                        process of amending under paragraph 
                        (2).
                          [(iii) Orders no longer effective.--
                        Any final sunscreen order included by 
                        the Secretary in a list described in 
                        clause (ii) and in a list included in 
                        resulting final regulations shall cease 
                        to be effective on the date that such 
                        final regulations including such order 
                        in such list become effective.
                          [(iv) Ingredients not grase.--If, 
                        notwithstanding a final sunscreen order 
                        stating that a nonprescription 
                        sunscreen active ingredient or 
                        combination of nonprescription 
                        sunscreen active ingredients is GRASE 
                        and is not misbranded if marketed in 
                        accordance with such order, while 
                        amending the regulations as described 
                        in clause (i), the Secretary concludes 
                        that such ingredient or combination of 
                        ingredients is no longer GRASE for use 
                        in nonprescription sunscreen, the 
                        Secretary shall, at the discretion of 
                        the Secretary, either initiate the 
                        process for amending the final 
                        sunscreen order set forth in paragraph 
                        (2) of this subsection or include in a 
                        proposed regulation an explanation and 
                        information supporting the 
                        determination of the Secretary that 
                        such ingredient or combination of 
                        ingredients is no longer GRASE for use 
                        in nonprescription sunscreen.
                  [(B) Procedure for updating regulations.--
                After the Secretary amends and finalizes the 
                regulations under part 352 of title 21, Code of 
                Federal Regulations under section 586E and such 
                regulations become effective, the Secretary may 
                use direct final rulemaking to include in such 
                regulations any nonprescription sunscreen 
                active ingredients that are the subject of 
                effective final sunscreen orders.]
          (3) Relationship to orders under section 505g.--A 
        final sunscreen order shall be deemed to be a final 
        order under section 505G.

           *       *       *       *       *       *       *


[SEC. 586E. SUNSCREEN MONOGRAPH.

  [(a) In General.--Not later than 5 years after the date of 
enactment of the Sunscreen Innovation Act, the Secretary shall 
amend and finalize regulations under part 352 of title 21, Code 
of Federal Regulations concerning nonprescription sunscreen 
that are effective not later than 5 years after such date of 
enactment. The Secretary shall publish such regulations not 
less than 30 calendar days before the effective date of such 
regulations.
  [(b) Reports.--If the regulations promulgated under 
subsection (a) do not include provisions related to the 
effectiveness of various sun protection factor levels, and do 
not address all dosage forms known to the Secretary to be used 
in sunscreens marketed in the United States without a new drug 
approval 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 such provisions 
not being included in such regulations, and a plan and timeline 
to compile any information necessary to address such provisions 
through final regulations.]

           *       *       *       *       *       *       *


SEC. 586H. SUNSET.

  This subchapter shall cease to be effective at the end of 
fiscal year 2022.

           *       *       *       *       *       *       *


CHAPTER VII--GENERAL AUTHORITY

           *       *       *       *       *       *       *


Subchapter C--Fees

           *       *       *       *       *       *       *


            PART 10--FEES RELATING TO OVER-THE-COUNTER DRUGS

SEC. 744N. DEFINITIONS.

  In 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 an OTC monograph drug facility where 
        neither the owner of such manufacturing facility nor 
        any affiliate of such owner or facility sells the OTC 
        monograph drug produced at such facility directly to 
        wholesalers, retailers, or consumers in the United 
        States.
          (3) The term ``costs of resources allocated for OTC 
        monograph drug activities'' means the expenses in 
        connection with OTC 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 costs related 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 744O and 
                accounting for resources allocated for OTC 
                monograph drug activities.
          (4) The term ``FDA establishment identifier'' is the 
        unique number automatically generated by Food and Drug 
        Administration's Field Accomplishments and Compliance 
        Tracking System (FACTS) (or any successor system).
          (5) The term ``OTC monograph drug'' means a 
        nonprescription drug without an approved new drug 
        application which is governed by the provisions of 
        section 505G.
          (6) The term ``OTC monograph drug activities'' means 
        activities of the Secretary associated with OTC 
        monograph drugs and inspection of facilities associated 
        with such products, including the following activities:
                  (A) The activities necessary for review and 
                evaluation of OTC monographs and OTC monograph 
                order requests, including--
                          (i) orders proposing or finalizing 
                        applicable conditions of use for OTC 
                        monograph drugs;
                          (ii) orders affecting status 
                        regarding general recognition of safety 
                        and effectiveness of an OTC monograph 
                        ingredient or combination of 
                        ingredients under specified conditions 
                        of use;
                          (iii) all OTC monograph drug 
                        development and review activities, 
                        including intraagency collaboration;
                          (iv) regulation and policy 
                        development activities related to OTC 
                        monograph drugs;
                          (v) development of product standards 
                        for products subject to review and 
                        evaluation;
                          (vi) meetings referred to in section 
                        505G(i);
                          (vii) review of labeling prior to 
                        issuance of orders related to OTC 
                        monograph drugs or conditions of use; 
                        and
                          (viii) regulatory science activities 
                        related to OTC monograph drugs.
                  (B) Inspections related to OTC monograph 
                drugs.
                  (C) Monitoring of clinical and other research 
                conducted in connection with OTC monograph 
                drugs.
                  (D) Safety activities with respect to OTC 
                monograph drugs, including--
                          (i) collecting, developing, and 
                        reviewing safety information on OTC 
                        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.
                  (E) Other activities necessary for 
                implementation of section 505G.
          (7) The term ``OTC monograph order request'' means a 
        request for an order submitted under section 
        505G(b)(5).
          (8) The term ``Tier 1 OTC monograph order request'' 
        means any OTC monograph order request not determined to 
        be a Tier 2 OTC monograph order request.
          (9)(A) The term ``Tier 2 OTC monograph order 
        request'' means, subject to subparagraph (B), an OTC 
        monograph order request for--
                  (i) the reordering of existing information in 
                the drug facts label of an OTC monograph drug;
                  (ii) the addition of information to the other 
                information section of the drug facts label of 
                an OTC monograph drug, as limited by section 
                201.66(c)(7) of title 21, Code of Federal 
                Regulations (or any successor regulations);
                  (iii) modification to the directions for use 
                section of the drug facts label of an OTC 
                monograph drug, if such changes conform to 
                changes made pursuant to section 505G(c)(3)(A);
                  (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 section 330.1 of title 21, Code 
                of Federal Regulations (or any successor 
                regulations).
          (B) The Secretary may, based on program 
        implementation experience or other factors found 
        appropriate by the Secretary, characterize any OTC 
        monograph order request as a Tier 2 OTC monograph order 
        request (including recharacterizing a request from Tier 
        1 to Tier 2) and publish such determination in a 
        proposed order issued pursuant to section 505G.
          (10)(A) The term ``OTC monograph drug facility'' 
        means a foreign or domestic business or other entity 
        that--
                  (i) is--
                          (I) under one management, either 
                        direct or indirect; and
                          (II) at one geographic location or 
                        address engaged in manufacturing or 
                        processing the finished dosage form of 
                        an OTC monograph drug;
                  (ii) includes a finished dosage form 
                manufacturer facility in a contractual 
                relationship with the sponsor of one or more 
                OTC monograph drugs to manufacture or process 
                such drugs; and
                  (iii) does not include a business or other 
                entity whose only manufacturing or processing 
                activities are one or more of the following: 
                production of clinical research supplies, or 
                testing.
          (B) For purposes of subparagraph (A)(i)(II), separate 
        buildings or locations within close proximity are 
        considered to be at one geographic location or address 
        if the activities conducted in such buildings or 
        locations are--
                  (i) closely related to the same business 
                enterprise;
                  (ii) under the supervision of the same local 
                management; and
                  (iii) under a single FDA 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 criteria 
        specified in subparagraph (A), 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.
          (11) The term ``OTC monograph drug meeting'' means 
        any meeting regarding the content of a proposed OTC 
        monograph order request.
          (12) The term ``person'' includes an affiliate of a 
        person.
          (13) The terms ``requestor'' and ``sponsor'' have the 
        meanings given such terms in section 505G.

SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH 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.--Each person that owns a 
                facility identified as an OTC 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) Exceptions.--
                          (i) A fee shall not be assessed under 
                        subparagraph (A) if the identified OTC 
                        monograph drug facility has ceased all 
                        activities related to OTC monograph 
                        drugs prior to the date specified in 
                        subparagraph (D)(ii) and has updated 
                        its registration to reflect such change 
                        under the requirements for drug 
                        establishment registration set forth in 
                        section 510.
                          (ii) The amount of the fee for a 
                        contract manufacturing organization 
                        facility shall be equal to \2/3\ the 
                        amount of the fee for an OTC monograph 
                        drug facility that is not a contract 
                        manufacturing organization facility.
                  (C) Amount.--The amount of fees established 
                under subparagraph (A) shall be established 
                under subsection (c).
                  (D) 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 enactment of an 
                                appropriations Act providing 
                                for the collection and 
                                obligation of fees under this 
                                section for such year.
          (2) OTC monograph order request fee.--
                  (A) In general.--Each person that submits an 
                OTC monograph order request shall be subject to 
                a fee for an OTC monograph order request. The 
                amount of such fee shall be--
                          (i) for a Tier 1 OTC monograph order 
                        request, $500,000, adjusted for 
                        inflation for the fiscal year (as 
                        determined under subsection (c)(1)(B)); 
                        and
                          (ii) for a Tier 2 OTC monograph order 
                        request, $100,000 adjusted for 
                        inflation for the fiscal year (as 
                        determined under subsection (c)(1)(B)).
                  (B) Due date.--The OTC monograph order 
                request fees required under subparagraph (A) 
                shall be due on the date of submission of the 
                OTC monograph order request.
                  (C) Exception for certain safety changes.--A 
                person who is named as the requestor in an OTC 
                monograph order shall not be subject to a fee 
                under subparagraph (A) if the Secretary finds 
                that the OTC monograph order request seeks to 
                change the drug facts labeling of an OTC 
                monograph drug 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 OTC 
                        monograph drug.
                  (D) Refund of fee if order request is 
                recategorized as a tier 2 otc monograph order 
                request.--If the Secretary determines that an 
                OTC monograph request initially characterized 
                as Tier 1 shall be re-characterized as a Tier 2 
                OTC monograph 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 which is refused for filing or was 
                withdrawn before being accepted or refused for 
                filing.
                  (F) Fees for order requests previously 
                refused for filing or withdrawn before 
                filing.--An OTC monograph 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 
                subparagraph shall not be reviewable.
          (3) Refunds.--
                  (A) In general.--Other than refunds provided 
                in subparagraphs (D) through (G) of paragraph 
                (2), the Secretary shall not refund any fee 
                paid under paragraph (1) 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 paragraph (1) or (2), a person 
                shall submit to the Secretary a written request 
                justifying such return within 180 calendar days 
                after such fee was paid.
          (4) Notice.--Within the timeframe specified in 
        subsection (c), the Secretary shall publish in the 
        Federal Register the amount of the fees under paragraph 
        (1) for such fiscal year.
  (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 (C).
                  (B) OTC monograph order request fees.--For 
                purposes of subsection (a)(2), the dollar 
                amount of the inflation adjustment to the fee 
                for OTC monograph order requests for fiscal 
                year 2020 and each subsequent fiscal year shall 
                be equal to the product of--
                          (i) the applicable fee under 
                        subsection (a)(2) for the preceding 
                        fiscal year; and
                          (ii) the inflation adjustment 
                        percentage under subparagraph (C).
                  (C) Inflation adjustment percentage.--The 
                inflation adjustment percentage under this 
                subparagraph for a fiscal year is equal to--
                          (i) for each of fiscal years 2020 and 
                        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 OTC monograph 
                                drug activities 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 OTC monograph 
                                drug activities for the first 3 
                                years of the preceding 4 fiscal 
                                years.
          (2) Operating reserve adjustment.--
                  (A) In general.--For fiscal year 2019 and 
                subsequent fiscal years, for purposes of 
                subsections (b)(1)(B) and (b)(2)(C), the 
                Secretary may, in addition to adjustments under 
                paragraph (1), further increase the fee revenue 
                and fees if such an adjustment is necessary to 
                provide operating reserves of carryover user 
                fees for OTC monograph drug activities for not 
                more than the number of weeks specified in 
                subparagraph (B).
                  (B) Number of weeks.--The number of weeks 
                specified in this subparagraph is--
                          (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) Decrease.--If the Secretary has carryover 
                balances for such process in excess of 10 weeks 
                of the operating reserves referred to in 
                subparagraph (A), the Secretary shall decrease 
                the fee revenue and fees referred to in such 
                subparagraph to provide for not more than 10 
                weeks of such operating reserves.
                  (D) Rationale for adjustment.--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 (4) 
                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 and fees for 
        purposes of subsection (b)(2)(D) 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 OTC monograph drug 
                        facility fees for fiscal year 2019 
                        under subsection (a), based on the 
                        revenue amount for such year under 
                        subsection (b) and the adjustments 
                        provided under this subsection; and
                          (ii) publish fee revenue, facility 
                        fees, and OTC monograph order requests 
                        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) OTC monograph drug facility fees 
                        under subsection (a)(1);
                          (ii) OTC monograph order request fees 
                        under subsection (a)(2); and
                          (iii) publish such fee revenue 
                        amounts, facility fees, and OTC 
                        monograph order request fees in the 
                        Federal Register.
  (d) Identification of Facilities.--Each person that owns an 
OTC 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 an OTC monograph drug facility.
  (e) Effect of Failure To Pay Fees.--
          (1) OTC monograph drug facility fee.--
                  (A) In general.--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 
                following:
                          (i) The Secretary shall place the 
                        facility on a publicly available 
                        arrears list.
                          (ii) All OTC monograph drugs 
                        manufactured in such a facility or 
                        containing an ingredient manufactured 
                        in such a facility shall be deemed 
                        misbranded under section 502(a).
                  (B) Application of penalties.--The penalties 
                under this paragraph shall apply until the fee 
                established by subsection (a)(1) is paid.
          (2) Order requests.--An OTC monograph 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 under this section have been paid.
          (3) Meetings.--A person subject to fees under this 
        section shall be considered ineligible for OTC 
        monograph drug meetings until all such fees owed by 
        such person have been paid.
  (f) 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 OTC 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 OTC 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 collected under 
                this section) no less than $12,000,000, 
                multiplied by the adjustment factor applicable 
                to the fiscal year involved under subsection 
                (c)(1).
                  (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 OTC 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.
  (g) 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, United 
States Code.
  (h) 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 OTC monograph 
drug activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.

SEC. 744P. 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 
Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 201(b) of the Over-the-Counter Monograph 
Safety, Innovation, and Reform Act of 2018 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 Energy and Commerce of 
the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate 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 the Congress with respect to the goals 
        described in subsection (a), and plans for meeting the 
        goals, for OTC 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 Energy and Commerce of 
                the House of Representatives;
                  (B) the Committee on Health, Education, 
                Labor, and Pensions of the Senate;
                  (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 the 
        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.

           *       *       *       *       *       *       *


                            ADDITIONAL VIEWS

    In addition to the creation of a user fee program for over-
the-counter (OTC) drugs, H.R. 5333 would transition the 
regulatory process for OTC drugs from one that establishes the 
safety and effectiveness of active ingredients through the 
finalization of a monograph under rule-making to administrative 
order. This streamlined process would also create a new pathway 
that would allow OTC drug manufacturers to pursue innovative 
changes to OTC drugs. This pathway would allow manufacturers to 
initiate a request for the Food and Drug Administration (FDA) 
to review a change in an active ingredient to a monograph, or 
to establish a drug not currently in a monograph. If FDA finds 
the drug or change in the monograph to be generally recognized 
as safe and effective (GRASE), the manufacturer would be 
rewarded with an exclusivity period of 18 months.
    While I am supportive of the creation of the OTC user fee 
program, as well as streamlining the safety and effectiveness 
determination of OTC active ingredients from a rule-making 
process to administrative order process, I have concerns about 
the inclusion of an exclusivity reward for OTC drug 
manufacturers. As we heard from Dr. Janet Woodcock, Director of 
FDA's Center for Drug Evaluation and Research (CDER), FDA has 
not been able to finalize many monographs to accommodate 
product innovation or marketing changes and as a result there 
has not been much innovation in the OTC market. More 
specifically, the current rule-making process is not flexible 
or nimble enough to accommodate advances in science or 
innovation and has resulted in many manufacturers shelving 
innovative ideas given the inability to bring them to market 
under the current monograph process. H.R. 5333 works to address 
this issue by creating a new pathway where manufacturers can 
initiate changes to a monograph through the streamlined 
administrative order process. This is an opportunity for 
innovation that does not exist today. It is my hope and belief 
that this new pathway will create an incentive for 
manufacturers to innovate that does not exist today by 
providing a timely and workable process for making changes to 
an OTC monograph.
    However, before implementing this new innovation pathway, 
and before even understanding whether this new innovation 
pathway is working to encourage innovation as Congress intends, 
H.R. 5333 would also create an exclusivity reward to provide 
OTC drug manufacturers with 18 months of exclusivity for 
innovations found to be GRASE under this new pathway. Such a 
step is not consistent with the creation of other user fee 
programs. Congress has not generally contemplated the creation 
of an exclusivity reward until it has been demonstrated that 
the current regulatory landscape and marketplace are not 
incentivizing needed innovation. For example, this was the case 
when Congress extended six months of exclusivity to 
manufacturers that conduct pediatric studies, and more recently 
when Congress extended six months of exclusivity to generic 
manufacturers that develop a competitor to current sole source 
drug products. H.R. 5333 would abandon this precedent and would 
award 18 months of exclusivity before any evidence is presented 
that the industry-initiated innovation pathway has not been 
sufficient in incentivizing innovation in the OTC drug market.
    Supporters of this exclusivity award have made many 
arguments as to why an exclusivity award may be necessary, such 
as claims that negotiations with retailers may be lengthy or 
that private label competition may begin right after an 
innovative product is launched. However, there has been no 
evidence that these arguments are justified, and further, there 
has not been a compelling policy argument presented as to why 
the new innovation pathway created under H.R. 5333 is not 
sufficient on its own to incentivize innovation.
    This Committee should take seriously the award of 
exclusivity in any context, and examine closely any policy 
proposal that holds the potential to keep affordable 
medications off the market for an extended period of time. 
While I have supported incentives in the past to encourage 
certain development and innovation, it has been after a 
compelling case has been made that the current marketplace and 
regulatory pathways were not working sufficiently. In 
considering such proposals, I have also always wanted to ensure 
that the incentives would not burden or impede access to the 
medications patients rely on. I do not believe that the current 
inclusion of an 18-month exclusivity award in H.R. 5333 meets 
this careful balance.
                                        Frank Pallone, Jr.,
                                                    Ranking Member.