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

<DOC>






115th CONGRESS
  2d Session
                                S. 2315

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            January 17, 2018

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

_______________________________________________________________________

                                 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; TABLE OF CONTENTS.

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

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

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

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

              TITLE I--REGULATION OF NONPRESCRIPTION DRUGS

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

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

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

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

SEC. 102. MISBRANDING.

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

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

    (a) Review of Nonprescription Ingredients Subject to Sunscreen 
Innovation Act.--
            (1) Pending sunscreen ingredients.--Nonprescription 
        sunscreen active ingredients or combinations of sunscreen 
        active ingredients subject, on the date of enactment of this 
        Act, to a proposed sunscreen order, as defined in section 
        586(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        360fff(7)), shall--
                    (A) continue to be reviewed in accordance with 
                section 586C of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360fff-3); or
                    (B) be reviewed under section 505G of such Act upon 
                notification of the Secretary by the sponsor that such 
                sponsor elects to have such ingredient or combination 
                of ingredients reviewed under such section 505G, and 
                such proposed sunscreen order under such section 586C 
                shall be considered a proposed administrative order 
                under section 505G(c)(3)(A)(ii) of such Act.
            (2) Pending nonsunscreen ingredients.--The sponsor of any 
        application described in section 586F of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360fff-6) that was submitted 
        to the Secretary of Health and Human Services (referred to in 
        this section as the ``Secretary'') pursuant to section 330.14 
        of title 21, Code of Federal Regulations (as in effect on the 
        day before the date of enactment of this Act), shall--
                    (A) notify the Secretary that the sponsor elects to 
                withdraw such application; or
                    (B) notify the Secretary that the sponsor elects 
                for such ingredient to be considered under section 505G 
                of the Federal Food, Drug, and Cosmetic Act, and any 
                proposed order under such section 586F shall be 
                considered a proposed administrative order under 
                section 505G(c)(3)(A)(ii) of that Act.
            (3) Ingredients submitted after the date of enactment of 
        section 506g.--Any ingredient that is eligible for review under 
        section 506G of the Federal Food, Drug, and Cosmetic Act and is 
        submitted after the date of enactment of this Act shall be 
        considered under that section.
    (b) Meetings Regarding Sunscreen Ingredients.--Section 586C(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(b)) is 
amended by adding at the end the following:
            ``(11) Meetings with sponsors.--A sponsor may request an 
        individual, confidential meeting to discuss the data 
        requirements to support a general recognition of safety and 
        effectiveness with respect to the subject of a pending 
        sunscreen ingredient. The Secretary shall respond within 14 
        calendar days of the request and schedule such meeting within 
        45 calendar days, or within such timeline as specified in the 
        letters described in section 201 of the Over-the-Counter Drug 
        Safety, Innovation, and Reform Act. If a sponsor requests more 
        than one confidential meeting for the same request, the 
        Secretary may refuse to grant an additional confidential 
        meeting request if the Secretary determines such additional 
        confidential meeting is not reasonably necessary for the 
        sponsor to advance its request. The Secretary shall publish a 
        post-meeting summary on the internet website of the Food and 
        Drug Administration of any confidential meeting that does not 
        disclose confidential business information. Such meetings shall 
        not be required to comply with guidance issued by the Secretary 
        addressing formal meetings for sponsors of human drug 
        applications, as defined in section 735.''.
    (c) Product Differentiation.--Section 586C of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360fff-3) is amended by adding at the 
end the following:
    ``(f) Product Differentiation.--
            ``(1) In general.--A final sunscreen order shall have the 
        effect of providing the order requestor (or the licensees, 
        assignees, or successors in interest of such requestor with 
        respect to the subject of such request and listed under 
        paragraph (5)) the exclusive right, for a period of 2 years, to 
        market a sunscreen ingredient under this section incorporating 
        changes described in paragraph (2) subject to the limitations 
        under paragraph (4), beginning on the date the requestor (or 
        any licensees, assignees, or successors in interest of such 
        requestor with respect to the subject of such request and 
        listed under paragraph (5)) may lawfully market such sunscreen 
        ingredient pursuant to the order.
            ``(2) Changes described.--A change described in this 
        paragraph is a change subject to an order specified in 
        paragraph (1) that--
                    ``(A) permits a sunscreen to contain an active 
                ingredient not previously incorporated in a marketed 
                sunscreen listed in paragraph (3); or
                    ``(B) permits a change in the conditions of use of 
                a sunscreen ingredient, for which human data studies 
                conducted or sponsored by the requestor (or for which 
                the requestor has an exclusive right of reference) were 
                essential to the issuance of such order.
            ``(3) Marketed sunscreen.--The marketed sunscreen 
        ingredients described this paragraph are sunscreen 
        ingredients--
                    ``(A) marketed in accordance with a final monograph 
                issued under part 330 of title 21, Code of Federal 
                Regulations (including conditions of use thereunder), 
                as in effect on the day before the date of enactment of 
                this section;
                    ``(B) marketed as category I or III in accordance 
                with a tentative final monograph issued under such part 
                330 (including conditions of use and any applicable 
                subsequent determinations thereunder), as so in effect;
                    ``(C) marketed as category I in accordance with an 
                advance notice of proposed rulemaking issued under such 
                part 330 (including conditions of use and any 
                applicable subsequent determinations thereunder), as so 
                in effect; or
                    ``(D) marketed in accordance with a final order 
                issued under this section.
            ``(4) Limitations on product differentiation.--
                    ``(A) Only one period.--Only one 2-year period may 
                be granted per ingredient under paragraph (1).
                    ``(B) Exclusions.--No period of product 
                differentiation under this subparagraph shall apply to 
                changes to a sunscreen that are--
                            ``(i) `Tier 2' changes described in section 
                        744L(14)(A);
                            ``(ii) safety-related changes described in 
                        section 744L-1(a)(2)(C), required under section 
                        505G(c)(5), or any other change the Secretary 
                        determines necessary to ensure safe use; or
                            ``(iii) changes related to methods of 
                        testing safety or efficacy.
            ``(5) Listing of licensees, assignees, or successors in 
        interest.--Requestors shall submit to the Secretary at the time 
        when a final dosage form subject to such request is introduced 
        or delivered for introduction into interstate commerce, a list 
        of licensees, assignees, or successors in interest that have 
        the exclusive right described in paragraph (1).
            ``(6) Human data defined.--For purposes of this subsection, 
        the term `human data' means data from clinical trials of safety 
        or effectiveness (including actual use studies), 
        pharmacokinetics, or bioavailability.''.
    (d) Sunscreen Innovation Act Amendments.--Section 586C(e) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff-3(e)) is amended 
by striking paragraph (3) and inserting the following:
            ``(3) Relationship to orders under section 505g.--A final 
        sunscreen order shall be deemed to be a final administrative 
        order under section 505G and subject to the applicable 
        provisions under such section 505G, including with respect to 
        amendment of such order.''.
    (e) Preclusion of New Sunscreen Submissions; Option To Transfer 
Submissions to OTC Monograph Order Process.--
            (1) Sunset.--Beginning on the date of enactment of this 
        Act, section 586A of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360fff-1) shall have no force or effect.
            (2) Option to transfer submissions to otc monograph order 
        process.--
                    (A) In general.--Any person who submitted a request 
                described in subparagraph (B) may, at any time prior to 
                the sunset of subchapter I of chapter V of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.) 
                under section 586H of such Act, withdraw such request 
                from the process under such subchapter and resubmit 
                such request as an order request under section 505G of 
                such Act.
                    (B) Requests.--A request described in this 
                subparagraph is--
                            (i) a request under section 586A of the 
                        Federal Food, Drug, and Cosmetic Act submitted 
                        before the date of enactment of this Act; or
                            (ii) a pending request described in section 
                        586(6).
    (f) Treatment of Authority Regarding Finalization of Sunscreen 
Monograph.--Section 586E of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360fff-5) is amended to read as follows:

``SEC. 586E. SUNSCREEN ORDER.

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

``SEC. 586H. SUNSET.

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

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

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

SEC. 105. CONFORMING AMENDMENT.

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

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

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

               TITLE II--FEES RELATING TO MONOGRAPH DRUGS

SEC. 201. SHORT TITLE; FINDINGS.

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

SEC. 202. AUTHORITY TO ACCESS AND USE FEES.

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

              ``PART 10--FEES RELATING TO MONOGRAPH DRUGS

``SEC. 744L. DEFINITIONS.

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

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

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

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

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