[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5333 Reported in House (RH)]

<DOC>





                                                 Union Calendar No. 640
115th CONGRESS
  2d Session
                                H. R. 5333

                          [Report No. 115-827]

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 19, 2018

   Mr. Latta (for himself, Mr. Burgess, Mr. Gene Green of Texas, Ms. 
DeGette, Mr. Guthrie, and Mrs. Dingell) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

                             July 16, 2018

   Additional sponsors: Ms. Matsui, Mr. Fleischmann, and Mr. Schrader

                             July 16, 2018

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on March 
                               19, 2018]


_______________________________________________________________________

                                 A BILL


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


 


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

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.''.
                                                 Union Calendar No. 640

115th CONGRESS

  2d Session

                               H. R. 5333

                          [Report No. 115-827]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             July 16, 2018

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