HR 4273 — Over-the-Counter Monograph Drug User Fee Amendments

changes in existing law made 
by the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

 FEDERAL FOOD, DRUG, AND COSMETIC ACT

 * * * * * * *

 CHAPTER V--DRUGS AND DEVICES

 Subchapter A--Drugs and Devices

 * * * * * * *

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

 (a) Nonprescription Drugs Marketed Without an Approved 
Application.--Nonprescription drugs marketed without an 
approved drug application under section 505, as of the date of 
the enactment of this section, shall be treated in accordance 
with this subsection.
 (1) Drugs subject to a final monograph; category i 
 drugs subject to a tentative final monograph.--A drug 
 is deemed to be generally recognized as safe and 
 effective under section 201(p)(1), not a new drug under 
 section 201(p), and not subject to section 503(b)(1), 
 if--
 (A) the drug is--
 (i) in conformity with the 
 requirements for nonprescription use of 
 a final monograph issued under part 330 
 of title 21, Code of Federal 
 Regulations (except as provided in 
 paragraph (2)), the general 
 requirements for nonprescription drugs, 
 and conditions or requirements under 
 subsections (b), (c), and (k); and
 (ii) except as permitted by an order 
 issued under subsection (b) or, in the 
 case of a minor change in the drug, in 
 conformity with an order issued under 
 subsection (c), in a dosage form that, 
 immediately prior to the date of the 
 enactment of this section, has been 
 used to a material extent and for a 
 material time under section 201(p)(2); 
 or
 (B) the drug is--
 (i) classified in category I for 
 safety and effectiveness under a 
 tentative final monograph that is the 
 most recently applicable proposal or 
 determination issued under part 330 of 
 title 21, Code of Federal Regulations;
 (ii) in conformity with the proposed 
 requirements for nonprescription use of 
 such tentative final monograph, any 
 applicable subsequent determination by 
 the Secretary, the general requirements 
 for nonprescription drugs, and 
 conditions or requirements under 
 subsections (b), (c), and (k); and
 (iii) except as permitted by an order 
 issued under subsection (b) or, in the 
 case of a minor change in the drug, in 
 conformity with an order issued under 
 subsection (c), in a dosage form that, 
 immediately prior to the date of the 
 enactment of this section, has been 
 used to a material extent and for a 
 material time under section 201(p)(2).
 (2) Treatment of sunscreen drugs.--With respect to 
 sunscreen drugs subject to this section, the applicable 
 requirements in terms of conformity with a final 
 monograph, for purposes of paragraph (1)(A)(i), shall 
 be the requirements specified in part 352 of title 21, 
 Code of Federal Regulations, as published on May 21, 
 1999, beginning on page 27687 of volume 64 of the 
 Federal Register, except that the applicable 
 requirements governing effectiveness and labeling shall 
 be those specified in section 201.327 of title 21, Code 
 of Federal Regulations.
 (3) Category iii drugs subject to a tentative final 
 monograph; category i drugs subject to proposed 
 monograph or advance notice of proposed rulemaking.--A 
 drug that is not described in paragraph (1), (2), or 
 (4) is not required to be the subject of an application 
 approved under section 505, and is not subject to 
 section 503(b)(1), if--
 (A) the drug is--
 (i) classified in category III for 
 safety or effectiveness in the preamble 
 of a proposed rule establishing a 
 tentative final monograph that is the 
 most recently applicable proposal or 
 determination for such drug issued 
 under part 330 of title 21, Code of 
 Federal Regulations;
 (ii) in conformity with--
 (I) the conditions of use, 
 including indication and dosage 
 strength, if any, described for 
 such category III drug in such 
 preamble or in an applicable 
 subsequent proposed rule;
 (II) the proposed 
 requirements for drugs 
 classified in such tentative 
 final monograph in category I 
 in the most recently proposed 
 rule establishing requirements 
 related to such tentative final 
 monograph and in any final rule 
 establishing requirements that 
 are applicable to the drug; and
 (III) the general 
 requirements for 
 nonprescription drugs and 
 conditions or requirements 
 under subsection (b) or (k); 
 and
 (iii) in a dosage form that, 
 immediately prior to the date of the 
 enactment of this section, had been 
 used to a material extent and for a 
 material time under section 201(p)(2); 
 or
 (B) the drug is--
 (i) classified in category I for 
 safety and effectiveness under a 
 proposed monograph or advance notice of 
 proposed rulemaking that is the most 
 recently applicable proposal or 
 determination for such drug issued 
 under part 330 of title 21, Code of 
 Federal Regulations;
 (ii) in conformity with the 
 requirements for nonprescription use of 
 such proposed monograph or advance 
 notice of proposed rulemaking, any 
 applicable subsequent determination by 
 the Secretary, the general requirements 
 for nonprescription drugs, and 
 conditions or requirements under 
 subsection (b) or (k); and
 (iii) in a dosage form that, 
 immediately prior to the date of the 
 enactment of this section, has been 
 used to a material extent and for a 
 material time under section 201(p)(2).
 (4) Category ii drugs deemed new drugs.--A drug that 
 is classified in category II for safety or 
 effectiveness under a tentative final monograph or that 
 is subject to a determination to be not generally 
 recognized as safe and effective in a proposed rule 
 that is the most recently applicable proposal issued 
 under part 330 of title 21, Code of Federal 
 Regulations, shall be deemed to be a new drug under 
 section 201(p), misbranded under section 502(ee), and 
 subject to the requirement for an approved new drug 
 application under section 505 beginning on the day that 
 is 180 calendar days after the date of the enactment of 
 this section, unless, before such day, the Secretary 
 determines that it is in the interest of public health 
 to extend the period during which the drug may be 
 marketed without such an approved new drug application.
 (5) Drugs not grase deemed new drugs.--A drug that 
 the Secretary has determined not to be generally 
 recognized as safe and effective under section 
 201(p)(1) under a final determination issued under part 
 330 of title 21, Code of Federal Regulations, shall be 
 deemed to be a new drug under section 201(p), 
 misbranded under section 502(ee), and subject to the 
 requirement for an approved new drug application under 
 section 505.
 (6) Other drugs deemed new drugs.--Except as provided 
 in subsection (m), a drug is deemed to be a new drug 
 under section 201(p) and misbranded under section 
 502(ee) if the drug--
 (A) is not subject to section 503(b)(1); and
 (B) is not described in paragraph (1), (2), 
 (3), (4), or (5), or subsection (b)(1)(B).
 (b) Administrative Orders.--
 (1) In general.--
 (A) Determination.--The Secretary may, on the 
 initiative of the Secretary or at the request 
 of one or more requestors, issue an 
 administrative order determining whether there 
 are conditions under which a specific drug, a 
 class of drugs, or a combination of drugs, is 
 determined to be--
 (i) not subject to section 503(b)(1); 
 and
 (ii) generally recognized as safe and 
 effective under section 201(p)(1).
 (B) Effect.--A drug or combination of drugs 
 shall be deemed to not require approval under 
 section 505 if such drug or combination of 
 drugs--
 (i) is determined by the Secretary to 
 meet the conditions specified in 
 clauses (i) and (ii) of subparagraph 
 (A);
 (ii) is marketed in conformity with 
 an administrative order under this 
 subsection;
 (iii) meets the general requirements 
 for nonprescription drugs; and
 (iv) meets the requirements under 
 subsections (c) and (k).
 (C) Standard.--The Secretary shall find that 
 a drug is not generally recognized as safe and 
 effective under section 201(p)(1) if--
 (i) the evidence shows that the drug 
 is not generally recognized as safe and 
 effective under section 201(p)(1); or
 (ii) the evidence is inadequate to 
 show that the drug is generally 
 recognized as safe and effective under 
 section 201(p)(1).
 (2) Administrative orders initiated by the 
 secretary.--
 (A) In general.--In issuing an administrative 
 order under paragraph (1) upon the Secretary's 
 initiative, the Secretary shall--
 (i) make reasonable efforts to notify 
 informally, not later than 2 business 
 days before the issuance of the 
 proposed order, the sponsors of drugs 
 who have a listing in effect under 
 section 510(j) for the drugs or 
 combination of drugs that will be 
 subject to the administrative order;
 (ii) after any such reasonable 
 efforts of notification--
 (I) issue a proposed 
 administrative order by 
 publishing it on the website of 
 the Food and Drug 
 Administration and include in 
 such order the reasons for the 
 issuance of such order; and
 (II) publish a notice of 
 availability of such proposed 
 order in the Federal Register;
 (iii) except as provided in 
 subparagraph (B), provide for a public 
 comment period with respect to such 
 proposed order of not less than 45 
 calendar days; and
 (iv) if, after completion of the 
 proceedings specified in clauses (i) 
 through (iii), the Secretary determines 
 that it is appropriate to issue a final 
 administrative order--
 (I) issue the final 
 administrative order, together 
 with a detailed statement of 
 reasons, which order shall not 
 take effect until the time for 
 requesting judicial review 
 under paragraph (3)(D)(ii) has 
 expired;
 (II) publish a notice of such 
 final administrative order in 
 the Federal Register;
 (III) afford [requestors] 
 sponsors or requestors of drugs 
 that will be subject to such 
 order the opportunity for 
 formal dispute resolution up to 
 the level of the Director of 
 the Center for Drug Evaluation 
 and Research, which initially 
 must be requested within 45 
 calendar days of the issuance 
 of the order, and, for 
 subsequent levels of appeal, 
 within 30 calendar days of the 
 prior decision; and
 (IV) except with respect to 
 drugs described in paragraph 
 (3)(B), upon completion of the 
 formal dispute resolution 
 procedure, inform the persons 
 which sought such dispute 
 resolution of their right to 
 request a hearing.
 (B) Exceptions.--When issuing an 
 administrative order under paragraph (1) on the 
 Secretary's initiative proposing to determine 
 that a drug described in subsection (a)(3) is 
 not generally recognized as safe and effective 
 under 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 under section 
 201(p)(1); and
 (II) the format for 
 submissions by interested 
 persons;
 (ii) the Secretary shall provide for 
 a public comment period of no less than 
 180 calendar days with respect to such 
 proposed order, except when the 
 Secretary determines, for good cause, 
 that a shorter period is in the 
 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 under 
 section 201(p)(1).
 (3) Hearings; judicial review.--
 (A) In general.--Only a person who 
 participated in each stage of formal dispute 
 resolution under subclause (III) of paragraph 
 (2)(A)(iv) of an administrative order with 
 respect to a drug may request a hearing 
 concerning a final administrative order issued 
 under such paragraph with respect to such drug. 
 If a hearing is sought, such person must submit 
 a request for a hearing, which shall be based 
 solely on information in the administrative 
 record, to the Secretary not later than 30 
 calendar days after receiving notice of the 
 final decision of the formal dispute resolution 
 procedure.
 (B) No hearing required with respect to 
 orders relating to certain drugs.--
 (i) In general.--The Secretary shall 
 not be required to provide notice and 
 an opportunity for a hearing pursuant 
 to paragraph (2)(A)(iv) if the final 
 administrative order involved relates 
 to a drug--
 (I) that is described in 
 subsection (a)(3)(A); and
 (II) with respect to which no 
 human or non-human data studies 
 relevant to the safety or 
 effectiveness of such drug have 
 been submitted to the 
 administrative record since the 
 issuance of the most recent 
 tentative final monograph 
 relating to such drug.
 (ii) Human data studies and non-human 
 data defined.--In this subparagraph:
 (I) The term ``human data 
 studies'' means clinical trials 
 of safety or effectiveness 
 (including actual use studies), 
 pharmacokinetics studies, or 
 bioavailability studies.
 (II) The term ``non-human 
 data'' means data from testing 
 other than with human subjects 
 which provides information 
 concerning safety or 
 effectiveness.
 (C) Hearing procedures.--
 (i) Denial of request for hearing.--
 If the Secretary determines that 
 information submitted in a request for 
 a hearing under subparagraph (A) with 
 respect to a final administrative order 
 issued under paragraph (2)(A)(iv) does 
 not identify the existence of a genuine 
 and substantial question of material 
 fact, the Secretary may deny such 
 request. In making such a 
 determination, the Secretary may 
 consider only information and data that 
 are based on relevant and reliable 
 scientific principles and 
 methodologies.
 (ii) Single hearing for multiple 
 related requests.--If more than one 
 request for a hearing is submitted with 
 respect to the same administrative 
 order under subparagraph (A), the 
 Secretary may direct that a single 
 hearing be conducted in which all 
 persons whose hearing requests were 
 granted may participate.
 (iii) Presiding officer.--The 
 presiding officer of a hearing 
 requested under subparagraph (A) 
 shall--
 (I) be designated by the 
 Secretary;
 (II) not be an employee of 
 the Center for Drug Evaluation 
 and Research; and
 (III) not have been 
 previously involved in the 
 development of the 
 administrative order involved 
 or proceedings relating to that 
 administrative order.
 (iv) Rights of parties to hearing.--
 The parties to a hearing requested 
 under subparagraph (A) shall have the 
 right to present testimony, including 
 testimony of expert witnesses, and to 
 cross-examine witnesses presented by 
 other parties. Where appropriate, the 
 presiding officer may require that 
 cross-examination by parties 
 representing substantially the same 
 interests be consolidated to promote 
 efficiency and avoid duplication.
 (v) Final decision.--
 (I) At the conclusion of a 
 hearing requested under 
 subparagraph (A), the presiding 
 officer of the hearing shall 
 issue a decision containing 
 findings of fact and 
 conclusions of law. The 
 decision of the presiding 
 officer shall be final.
 (II) The final decision may 
 not take effect until the 
 period under subparagraph 
 (D)(ii) for submitting a 
 request for judicial review of 
 such decision expires.
 (D) Judicial review of final administrative 
 order.--
 (i) In general.--The procedures 
 described in section 505(h) shall apply 
 with respect to judicial review of 
 final administrative orders issued 
 under this subsection in the same 
 manner and to the same extent as such 
 section applies to an order described 
 in such section except that the 
 judicial review shall be taken by 
 filing in an appropriate district court 
 of the United States in lieu of the 
 appellate courts specified in such 
 section.
 (ii) Period to submit a request for 
 judicial review.--A person eligible to 
 request a hearing under this paragraph 
 and seeking judicial review of a final 
 administrative order issued under this 
 subsection shall file such request for 
 judicial review not later than 60 
 calendar days after the latest of--
 (I) the date on which notice 
 of such order is published;
 (II) the date on which a 
 hearing with respect to such 
 order is denied under 
 subparagraph (B) or (C)(i);
 (III) the date on which a 
 final decision is made 
 following a hearing under 
 subparagraph (C)(v); or
 (IV) if no hearing is 
 requested, the date on which 
 the time for requesting a 
 hearing expires.
 (4) Expedited procedure with respect to 
 administrative orders initiated by the secretary.--
 (A) Imminent hazard to the public health.--
 (i) In general.--In the case of a 
 determination by the Secretary that a 
 drug, class of drugs, or combination of 
 drugs subject to this section poses an 
 imminent hazard to the public health, 
 the Secretary, after first making 
 reasonable efforts to notify, not later 
 than 48 hours before issuance of such 
 order under this subparagraph, sponsors 
 who have a listing in effect under 
 section 510(j) for such drug or 
 combination of drugs--
 (I) may issue an interim 
 final administrative order for 
 such drug, class of drugs, or 
 combination of drugs under 
 paragraph (1), together with a 
 detailed statement of the 
 reasons for such order;
 (II) shall publish in the 
 Federal Register a notice of 
 availability of any such order; 
 and
 (III) shall provide for a 
 public comment period of at 
 least 45 calendar days with 
 respect to such interim final 
 order.
 (ii) Nondelegation.--The Secretary 
 may not delegate the authority to issue 
 an interim final administrative order 
 under this subparagraph.
 (B) Safety labeling changes.--
 (i) In general.--In the case of a 
 determination by the Secretary that a 
 change in the labeling of a drug, class 
 of drugs, or combination of drugs 
 subject to this section is reasonably 
 expected to mitigate a significant or 
 unreasonable risk of a serious adverse 
 event associated with use of the drug, 
 the Secretary may--
 (I) make reasonable efforts 
 to notify informally, not later 
 than 48 hours before the 
 issuance of the interim final 
 order, the sponsors of drugs 
 who have a listing in effect 
 under section 510(j) for such 
 drug or combination of drugs;
 (II) after reasonable efforts 
 of notification, issue an 
 interim final administrative 
 order in accordance with 
 paragraph (1) to require such 
 change, together with a 
 detailed statement of the 
 reasons for such order;
 (III) publish in the Federal 
 Register a notice of 
 availability of such order; and
 (IV) provide for a public 
 comment period of at least 45 
 calendar days with respect to 
 such interim final order.
 (ii) Content of order.--An interim 
 final order issued under this 
 subparagraph with respect to the 
 labeling of a drug may provide for new 
 warnings and other information required 
 for safe use of the drug.
 (C) Effective date.--An order under 
 subparagraph (A) or (B) shall take effect on a 
 date specified by the Secretary.
 (D) Final order.--After the completion of the 
 proceedings in subparagraph (A) or (B), the 
 Secretary shall--
 (i) issue a final order in accordance 
 with paragraph (1);
 (ii) publish a notice of availability 
 of such final administrative order in 
 the Federal Register; and
 (iii) afford sponsors of such drugs 
 that will be subject to such an order 
 the opportunity for formal dispute 
 resolution up to the level of the 
 Director of the Center for Drug 
 Evaluation and Research, which must 
 initially be within 45 calendar days of 
 the issuance of the order, and for 
 subsequent levels of appeal, within 30 
 calendar days of the prior decision.
 (E) Hearings.--A sponsor of a drug subject to 
 a final order issued under subparagraph (D) and 
 that participated in each stage of formal 
 dispute resolution under clause (iii) of such 
 subparagraph may request a hearing on such 
 order. The provisions of subparagraphs (A), 
 (B), and (C) of paragraph (3), other than 
 paragraph (3)(C)(v)(II), shall apply with 
 respect to a hearing on such order in the same 
 manner and to the same extent as such 
 provisions apply with respect to a hearing on 
 an administrative order issued under paragraph 
 (2)(A)(iv).
 (F) Timing.--
 (i) Final order and hearing.--The 
 Secretary shall--
 (I) not later than 6 months 
 after the date on which the 
 comment period closes under 
 subparagraph (A) or (B), issue 
 a final order in accordance 
 with paragraph (1); and
 (II) not later than 12 months 
 after the date on which such 
 final order is issued, complete 
 any hearing under subparagraph 
 (E).
 (ii) Dispute resolution request.--The 
 Secretary shall specify in an interim 
 final order issued under subparagraph 
 (A) or (B) such shorter periods for 
 requesting dispute resolution under 
 subparagraph (D)(iii) as are necessary 
 to meet the requirements of this 
 subparagraph.
 (G) Judicial review.--A final order issued 
 pursuant to subparagraph (F) shall be subject 
 to judicial review in accordance with paragraph 
 (3)(D).
 (5) Administrative order initiated at the request of 
 a requestor.--
 (A) In general.--In issuing an administrative 
 order under paragraph (1) at the request of a 
 requestor with respect to certain drugs, 
 classes of drugs, or combinations of drugs--
 (i) the Secretary shall, after 
 receiving a request under this 
 subparagraph, determine whether the 
 request is sufficiently complete and 
 formatted to permit a substantive 
 review;
 (ii) if the Secretary determines that 
 the request is sufficiently complete 
 and formatted to permit a substantive 
 review, the Secretary shall--
 (I) file the request; and
 (II) initiate proceedings 
 with respect to issuing an 
 administrative order in 
 accordance with paragraphs (2) 
 and (3); and
 (iii) except as provided in paragraph 
 (6), if the Secretary determines that a 
 request does not meet the requirements 
 for filing or is not sufficiently 
 complete and formatted to permit a 
 substantive review, the requestor may 
 demand that the request be filed over 
 protest, and the Secretary shall 
 initiate proceedings to review the 
 request in accordance with paragraph 
 (2)(A).
 (B) Request to initiate proceedings.--
 (i) In general.--A requestor seeking 
 an administrative order under paragraph 
 (1) with respect to certain drugs, 
 classes of drugs, or combinations of 
 drugs, shall submit to the Secretary a 
 request to initiate proceedings for 
 such order in the form and manner as 
 specified by the Secretary. Such 
 requestor may submit a request under 
 this subparagraph for the issuance of 
 an administrative order--
 (I) determining whether a 
 drug is generally recognized as 
 safe and effective under 
 section 201(p)(1), exempt from 
 section 503(b)(1), and not 
 required to be the subject of 
 an approved application under 
 section 505; or
 (II) determining whether a 
 change to a condition of use of 
 a drug is generally recognized 
 as safe and effective under 
 section 201(p)(1), exempt from 
 section 503(b)(1), and not 
 required to be the subject of 
 an approved application under 
 section 505, if, absent such a 
 changed condition of use, such 
 drug is--
 (aa) generally 
 recognized as safe and 
 effective under section 
 201(p)(1) in accordance 
 with subsection (a)(1), 
 (a)(2), or an order 
 under this subsection; 
 or
 (bb) subject to 
 subsection (a)(3), but 
 only if such requestor 
 initiates such request 
 in conjunction with a 
 request for the 
 Secretary to determine 
 whether such drug is 
 generally recognized as 
 safe and effective 
 under section 
 201(p)(1), which is 
 filed by the Secretary 
 under subparagraph 
 (A)(ii).
 (ii) Exception.--The Secretary is not 
 required to complete review of a 
 request for a change described in 
 clause (i)(II) if the Secretary 
 determines that there is an inadequate 
 basis to find the drug is generally 
 recognized as safe and effective under 
 section 201(p)(1) under paragraph (1) 
 and issues a final order announcing 
 that determination.
 (iii) Withdrawal.--The requestor may 
 withdraw a request under this 
 paragraph, according to the procedures 
 set forth pursuant to subsection 
 (d)(2)(B). Notwithstanding any other 
 provision of this section, if such 
 request is withdrawn, the Secretary may 
 cease proceedings under this 
 subparagraph.
 (C) Exclusivity.--
 (i) In general.--A final 
 administrative order issued in response 
 to a request under this section shall 
 have the effect of authorizing solely 
 the order requestor (or the licensees, 
 assignees, or successors in interest of 
 such requestor with respect to the 
 subject of such order), for a period of 
 18 months following the effective date 
 of such final order and beginning on 
 the date the requestor may lawfully 
 market such drugs pursuant to the 
 order, to market drugs--
 (I) incorporating changes 
 described in clause (ii); and
 (II) subject to the 
 limitations under clause (iv).
 (ii) Changes described.--A change 
 described in this clause is a change 
 subject to an order specified in clause 
 (i), which--
 (I) provides for a drug to 
 contain an active ingredient 
 (including any ester or salt of 
 the active ingredient) not 
 previously incorporated in a 
 drug described in clause (iii); 
 or
 (II) provides for a change in 
 the conditions of use of a 
 drug, for which new human data 
 studies conducted or sponsored 
 by the requestor (or for which 
 the requestor has an exclusive 
 right of reference) were 
 essential to the issuance of 
 such order.
 (iii) Drugs described.--The drugs 
 described in this clause are drugs--
 (I) specified in subsection 
 (a)(1), (a)(2), or (a)(3);
 (II) subject to a final order 
 issued under this section;
 (III) subject to a final 
 sunscreen order (as defined in 
 section 586(2)(A)); or
 (IV) described in subsection 
 (m)(1), other than drugs 
 subject to an active 
 enforcement action under 
 chapter III of this Act.
 (iv) Limitations on exclusivity.--
 (I) In general.--Only one 18-
 month period under this 
 subparagraph shall be granted, 
 under each order described in 
 clause (i), with respect to 
 changes (to the drug subject to 
 such order) which are either--
 (aa) changes 
 described in clause 
 (ii)(I), relating to 
 active ingredients; or
 (bb) changes 
 described in clause 
 (ii)(II), relating to 
 conditions of use.
 (II) No exclusivity 
 allowed.--No exclusivity shall 
 apply to changes to a drug 
 which are--
 (aa) the subject of a 
 Tier 2 OTC monograph 
 order request (as 
 defined in section 
 744L);
 (bb) safety-related 
 changes, as defined by 
 the Secretary, or any 
 other changes the 
 Secretary considers 
 necessary to assure 
 safe use; or
 (cc) changes related 
 to methods of testing 
 safety or efficacy.
 (v) New human data studies defined.--
 In this subparagraph, the term ``new 
 human data studies'' means clinical 
 trials of safety or effectiveness 
 (including actual use studies), 
 pharmacokinetics studies, or 
 bioavailability studies, the results of 
 which--
 (I) have not been relied on 
 by the Secretary to support--
 (aa) a proposed or 
 final determination 
 that a drug described 
 in subclause (I), (II), 
 or (III) of clause 
 (iii) is generally 
 recognized as safe and 
 effective under section 
 201(p)(1); or
 (bb) approval of a 
 drug that was approved 
 under section 505; and
 (II) do not duplicate the 
 results of another study that 
 was relied on by the Secretary 
 to support--
 (aa) a proposed or 
 final determination 
 that a drug described 
 in subclause (I), (II), 
 or (III) of clause 
 (iii) is generally 
 recognized as safe and 
 effective under section 
 201(p)(1); or
 (bb) approval of a 
 drug that was approved 
 under section 505.
 (vi) Notification of drug not 
 available for sale.--A requestor that 
 is granted exclusivity with respect to 
 a drug under this subparagraph shall 
 notify the Secretary in writing within 
 1 year of the issuance of the final 
 administrative order if the drug that 
 is the subject of such order will not 
 be available for sale within 1 year of 
 the date of issuance of such order. The 
 requestor shall include with such 
 notice the--
 (I) identity of the drug by 
 established name and by 
 proprietary name, if any;
 (II) strength of the drug;
 (III) date on which the drug 
 will be available for sale, if 
 known; and
 (IV) reason for not marketing 
 the drug after issuance of the 
 order.
 (6) Information regarding safe nonprescription 
 marketing and use as condition for filing a generally 
 recognized as safe and effective request.--
 (A) In general.--In response to a request 
 under this section that a drug described in 
 subparagraph (B) be generally recognized as 
 safe and effective, the Secretary--
 (i) may file such request, if the 
 request includes information specified 
 under subparagraph (C) with respect to 
 safe nonprescription marketing and use 
 of such drug; or
 (ii) if the request fails to include 
 information specified under 
 subparagraph (C), shall refuse to file 
 such request and require that 
 nonprescription marketing of the drug 
 be pursuant to a new drug application 
 as described in subparagraph (D).
 (B) Drug described.--A drug described in this 
 subparagraph is a nonprescription drug which 
 contains an active ingredient not previously 
 incorporated in a drug--
 (i) specified in subsection (a)(1), 
 (a)(2), or (a)(3);
 (ii) subject to a final order under 
 this section; or
 (iii) subject to a final sunscreen 
 order (as defined in section 
 586(2)(A)).
 (C) Information demonstrating prima facie 
 safe nonprescription marketing and use.--
 Information specified in this subparagraph, 
 with respect to a request described in 
 subparagraph (A)(i), is--
 (i) information sufficient for a 
 prima facie demonstration that the drug 
 subject to such request has a 
 verifiable history of being marketed 
 and safely used by consumers in the 
 United States as a nonprescription drug 
 under comparable conditions of use;
 (ii) if the drug has not been 
 previously marketed in the United 
 States as a nonprescription drug, 
 information sufficient for a prima 
 facie demonstration that the drug was 
 marketed and safely used under 
 comparable conditions of marketing and 
 use in a country listed in section 
 802(b)(1)(A) or designated by the 
 Secretary in accordance with section 
 802(b)(1)(B)--
 (I) for such period as needed 
 to provide reasonable 
 assurances concerning the safe 
 nonprescription use of the 
 drug; and
 (II) during such time was 
 subject to sufficient 
 monitoring by a regulatory body 
 considered acceptable by the 
 Secretary for such monitoring 
 purposes, including for adverse 
 events associated with 
 nonprescription use of the 
 drug; or
 (iii) if the Secretary determines 
 that information described in clause 
 (i) or (ii) is not needed to provide a 
 prima facie demonstration that the drug 
 can be safely marketed and used as a 
 nonprescription drug, such other 
 information the Secretary determines is 
 sufficient for such purposes.
 (D) Marketing pursuant to new drug 
 application.--In the case of a request 
 described in subparagraph (A)(ii), the drug 
 subject to such request may be resubmitted for 
 filing only if--
 (i) the drug is marketed as a 
 nonprescription drug, under conditions 
 of use comparable to the conditions 
 specified in the request, for such 
 period as the Secretary determines 
 appropriate (not to exceed 5 
 consecutive years) pursuant to an 
 application approved under section 505; 
 and
 (ii) during such period, 1,000,000 
 retail packages of the drug, or an 
 equivalent quantity as determined by 
 the Secretary, were distributed for 
 retail sale, as determined in such 
 manner as the Secretary finds 
 appropriate.
 (E) Rule of application.--Except in the case 
 of a request involving a drug described in 
 section 586(9), as in effect on January 1, 
 2017, if the Secretary refuses to file a 
 request under this paragraph, the requestor may 
 not file such request over protest under 
 paragraph (5)(A)(iii).
 (7) Packaging.--An administrative order issued under 
 paragraph (2), (4)(A), or (5) may include requirements 
 for the packaging of a drug to encourage use in 
 accordance with labeling. Such requirements may include 
 unit dose packaging, requirements for products intended 
 for use by pediatric populations, requirements to 
 reduce risk of harm from unsupervised ingestion, and 
 other appropriate requirements. This paragraph does not 
 authorize the Food and Drug Administration to require 
 standards or testing procedures as described in part 
 1700 of title 16, Code of Federal Regulations.
 (8) Final and tentative final monographs for category 
 i drugs deemed final administrative orders.--
 (A) In general.--A final monograph or 
 tentative final monograph described in 
 subparagraph (B) shall be deemed to be a final 
 administrative order under this subsection and 
 may be amended, revoked, or otherwise modified 
 in accordance with the procedures of this 
 subsection.
 (B) Monographs described.--For purposes of 
 subparagraph (A), a final monograph or 
 tentative final monograph is described in this 
 subparagraph if it--
 (i) establishes conditions of use for 
 a drug described in paragraph (1) or 
 (2) of subsection (a); and
 (ii) represents the most recently 
 promulgated version of such conditions, 
 including as modified, in whole or in 
 part, by any proposed or final rule.
 (C) Deemed orders include harmonizing 
 technical amendments.--The deemed establishment 
 of a final administrative order under 
 subparagraph (A) shall be construed to include 
 any technical amendments to such order as the 
 Secretary determines necessary to ensure that 
 such order is appropriately harmonized, in 
 terms of terminology or cross-references, with 
 the applicable provisions of this Act (and 
 regulations thereunder) and any other orders 
 issued under this section.
 (c) Procedure for Minor Changes.--
 (1) In general.--Minor changes in the dosage form of 
 a drug that is described in paragraph (1) or (2) of 
 subsection (a) or the subject of an order issued under 
 subsection (b) may be made by a requestor without the 
 issuance of an order under subsection (b) if--
 (A) the requestor maintains such information 
 as is necessary to demonstrate that the 
 change--
 (i) will not affect the safety or 
 effectiveness of the drug; and
 (ii) will not materially affect the 
 extent of absorption or other exposure 
 to the active ingredient in comparison 
 to a suitable reference product; and
 (B) the change is in conformity with the 
 requirements of an applicable administrative 
 order issued by the Secretary under paragraph 
 (3).
 (2) Additional information.--
 (A) Access to records.--A sponsor shall 
 submit records requested by the Secretary 
 relating to such a minor change under section 
 704(a)(4), within 15 business days of receiving 
 such a request, or such longer period as the 
 Secretary may provide.
 (B) Insufficient information.--If the 
 Secretary determines that the information 
 contained in such records is not sufficient to 
 demonstrate that the change does not affect the 
 safety or effectiveness of the drug or 
 materially affect the extent of absorption or 
 other exposure to the active ingredient, the 
 Secretary--
 (i) may so inform the sponsor of the 
 drug in writing; and
 (ii) if the Secretary so informs the 
 sponsor, shall provide the sponsor of 
 the drug with a reasonable opportunity 
 to provide additional information.
 (C) Failure to submit sufficient 
 information.--If the sponsor fails to provide 
 such additional information within a time 
 prescribed by the Secretary, or if the 
 Secretary determines that such additional 
 information does not demonstrate that the 
 change does not--
 (i) affect the safety or 
 effectiveness of the drug; or
 (ii) materially affect the extent of 
 absorption or other exposure to the 
 active ingredient in comparison to a 
 suitable reference product,
 the drug as modified is a new drug under 
 section 201(p) and shall be deemed to be 
 misbranded under section 502(ee).
 (3) Determining whether a change will affect safety 
 or effectiveness.--
 (A) In general.--The Secretary shall issue 
 one or more administrative orders specifying 
 requirements for determining whether a minor 
 change made by a sponsor pursuant to this 
 subsection will affect the safety or 
 effectiveness of a drug or materially affect 
 the extent of absorption or other exposure to 
 an active ingredient in the drug in comparison 
 to a suitable reference product, together with 
 guidance for applying those orders to specific 
 dosage forms.
 (B) Standard practices.--The orders and 
 guidance issued by the Secretary under 
 subparagraph (A) shall take into account 
 relevant public standards and standard 
 practices for evaluating the quality of drugs, 
 and may take into account the special needs of 
 populations, including children.
 (d) Confidentiality of Information Submitted to the 
Secretary.--
 (1) In general.--Subject to paragraph (2), any 
 information, including reports of testing conducted on 
 the drug or drugs involved, that is submitted by a 
 requestor in connection with proceedings on an order 
 under this section (including any minor change under 
 subsection (c)) and is a trade secret or confidential 
 information subject to section 552(b)(4) of title 5, 
 United States Code, or section 1905 of title 18, United 
 States Code, shall not be disclosed to the public 
 unless the requestor consents to that disclosure.
 (2) Public availability.--
 (A) In general.--Except as provided in 
 subparagraph (B), the Secretary shall--
 (i) make any information submitted by 
 a requestor in support of a request 
 under subsection (b)(5)(A) available to 
 the public not later than the date on 
 which the proposed order is issued; and
 (ii) make any information submitted 
 by any other person with respect to an 
 order requested (or initiated by the 
 Secretary) under subsection (b), 
 available to the public upon such 
 submission.
 (B) Limitations on public availability.--
 Information described in subparagraph (A) shall 
 not be made public if--
 (i) the information pertains to 
 pharmaceutical quality information, 
 unless such information is necessary to 
 establish standards under which a drug 
 is generally recognized as safe and 
 effective under section 201(p)(1);
 (ii) the information is submitted in 
 a requestor-initiated request, but the 
 requestor withdraws such request, in 
 accordance with withdrawal procedures 
 established by the Secretary, before 
 the Secretary issues the proposed 
 order;
 (iii) the Secretary requests and 
 obtains the information under 
 subsection (c) and such information is 
 not submitted in relation to an order 
 under subsection (b); or
 (iv) the information is of the type 
 contained in raw datasets.
 (e) Updates to Drug Listing Information.--A sponsor who makes 
a change to a drug subject to this section shall submit updated 
drug listing information for the drug in accordance with 
section 510(j) within 30 calendar days of the date when the 
drug is first commercially marketed, except that a sponsor who 
was the order requestor with respect to an order subject to 
subsection (b)(5)(C) (or a licensee, assignee, or successor in 
interest of such requestor) shall submit updated drug listing 
information on or before the date when the drug is first 
commercially marketed.
 (f) Approvals Under Section 505.--The provisions of this 
section shall not be construed to preclude a person from 
seeking or maintaining the approval of an application for a 
drug under sections 505(b)(1), 505(b)(2), and 505(j). A 
determination under this section that a drug is not subject to 
section 503(b)(1), is generally recognized as safe and 
effective under section 201(p)(1), and is not a new drug under 
section 201(p) shall constitute a finding that the drug is safe 
and effective that may be relied upon for purposes of an 
application under section 505(b)(2), so that the applicant 
shall be required to submit for purposes of such application 
only information needed to support any modification of the drug 
that is not covered by such determination under this section.
 (g) Public Availability of Administrative Orders.--The 
Secretary shall establish, maintain, update (as determined 
necessary by the Secretary but no less frequently than 
annually), and make publicly available, with respect to orders 
issued under this section--
 (1) a repository of each final order and interim 
 final order in effect, including the complete text of 
 the order; and
 (2) a listing of all orders proposed and under 
 development under subsection (b)(2), including--
 (A) a brief description of each such order; 
 and
 (B) the Secretary's expectations, if 
 resources permit, for issuance of proposed 
 orders over a 3-year period.
 (h) Development Advice to Sponsors or Requestors.--The 
Secretary shall establish procedures under which [sponsors or 
requestors] sponsors, requestors, or organizations nominated by 
sponsors or requestors to represent their interests in a 
proceeding may meet with appropriate officials of the Food and 
Drug Administration to obtain advice on the studies and other 
information necessary to support submissions under this section 
and other matters relevant to the regulation of nonprescription 
drugs and the development of new nonprescription drugs under 
this section.
 (i) Participation of Multiple Sponsors or Requestors.--The 
Secretary shall establish procedures to facilitate efficient 
participation by multiple sponsors or requestors in proceedings 
under this section, including provision for joint meetings with 
multiple sponsors or requestors or with organizations nominated 
by sponsors or requestors to represent their interests in a 
proceeding.
 (j) Electronic Format.--All submissions under this section 
shall be in electronic format.
 (k) Effect on Existing Regulations Governing Nonprescription 
Drugs.--
 (1) Regulations of general applicability to 
 nonprescription drugs.--Except as provided in this 
 subsection, nothing in this section supersedes 
 regulations establishing general requirements for 
 nonprescription drugs, including regulations of general 
 applicability contained in parts 201, 250, and 330 of 
 title 21, Code of Federal Regulations, or any successor 
 regulations. The Secretary shall establish or modify 
 such regulations by means of rulemaking in accordance 
 with section 553 of title 5, United States Code.
 (2) Regulations establishing requirements for 
 specific nonprescription drugs.--
 (A) The provisions of section 310.545 of 
 title 21, Code of Federal Regulations, as in 
 effect on the day before the date of the 
 enactment of this section, shall be deemed to 
 be a final order under subsection (b).
 (B) Regulations in effect on the day before 
 the date of the enactment of this section, 
 establishing requirements for specific 
 nonprescription drugs marketed pursuant to this 
 section (including such requirements in parts 
 201 and 250 of title 21, Code of Federal 
 Regulations), shall be deemed to be final 
 orders under subsection (b), only as they apply 
 to drugs--
 (i) subject to paragraph (1), (2), 
 (3), or (4) of subsection (a); or
 (ii) otherwise subject to an order 
 under this section.
 (3) Withdrawal of regulations.--The Secretary shall 
 withdraw regulations establishing final monographs and 
 the procedures governing the over-the-counter drug 
 review under part 330 and other relevant parts of title 
 21, Code of Federal Regulations (as in effect on the 
 day before the date of the enactment of this section), 
 or make technical changes to such regulations to ensure 
 conformity with appropriate terminology and cross 
 references. Notwithstanding subchapter II of chapter 5 
 of title 5, United States Code, any such withdrawal or 
 technical changes shall be made without public notice 
 and comment and shall be effective upon publication 
 through notice in the Federal Register (or upon such 
 date as specified in such notice).
 (l) Guidance.--The Secretary shall issue guidance that 
specifies--
 (1) the procedures and principles for formal meetings 
 between the Secretary and sponsors or requestors for 
 drugs subject to this section;
 (2) the format and content of data submissions to the 
 Secretary under this section;
 (3) the format of electronic submissions to the 
 Secretary under this section;
 (4) consolidated proceedings for appeal and the 
 procedures for such proceedings where appropriate; and
 (5) for minor changes in drugs, recommendations on 
 how to comply with the requirements in orders issued 
 under subsection (c)(3).
 (m) Rule of Construction.--
 (1) In general.--This section shall not affect the 
 treatment or status of a nonprescription drug--
 (A) that is marketed without an application 
 approved under section 505 as of the date of 
 the enactment of this section;
 (B) that is not subject to an order issued 
 under this section; and
 (C) to which paragraph (1), (2), (3), (4), or 
 (5) of subsection (a) do not apply.
 (2) Treatment of products previously found to be 
 subject to time and extent requirements.--
 (A) Notwithstanding subsection (a), a drug 
 described in subparagraph (B) may only be 
 lawfully marketed, without an application 
 approved under section 505, pursuant to an 
 order issued under this section.
 (B) A drug described in this subparagraph is 
 a drug which, prior to the date of the 
 enactment of this section, the Secretary 
 determined in a proposed or final rule to be 
 ineligible for review under the OTC drug review 
 (as such phrase ``OTC drug review'' was used in 
 section 330.14 of title 21, Code of Federal 
 Regulations, as in effect on the day before the 
 date of the enactment of this section).
 (3) Preservation of authority.--
 (A) Nothing in paragraph (1) shall be 
 construed to preclude or limit the 
 applicability of any provision of this Act 
 other than this section.
 (B) Nothing in subsection (a) shall be 
 construed to prohibit the Secretary from 
 issuing an order under this section finding a 
 drug to be not generally recognized as safe and 
 effective under section 201(p)(1), as the 
 Secretary determines appropriate.
 (n) Investigational New Drugs.--A drug is not subject to this 
section if an exemption for investigational use under section 
505(i) is in effect for such drug.
 (o) Inapplicability of Paperwork Reduction Act.--Chapter 35 
of title 44, United States Code, shall not apply to collections 
of information made under this section.
 (p) Inapplicability of Notice and Comment Rulemaking and 
Other Requirements.--The requirements of subsection (b) shall 
apply with respect to orders issued under this section instead 
of the requirements of subchapter II of chapter 5 of title 5, 
United States Code.
 (q) Definitions.--In this section:
 (1) The term ``nonprescription drug'' refers to a 
 drug not subject to the requirements of section 
 503(b)(1).
 (2) The term ``sponsor'' refers to any person 
 marketing, manufacturing, or processing a drug that--
 (A) is listed pursuant to section 510(j); and
 (B) is or will be subject to an 
 administrative order under this section of the 
 Food and Drug Administration.
 (3) The term ``requestor'' refers to any person or 
 group of persons marketing, manufacturing, processing, 
 or developing a drug.

 * * * * * * *

 CHAPTER VII--GENERAL AUTHORITY

 * * * * * * *

 Subchapter C--Fees

 * * * * * * *

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

SEC. 744L. DEFINITIONS.

 In this part:
 (1) The term ``affiliate'' means a business entity 
 that has a relationship with a second business entity 
 if, directly or indirectly--
 (A) one business entity controls, or has the 
 power to control, the other business entity; or
 (B) a third party controls, or has power to 
 control, both of the business entities.
 (2) The term ``contract manufacturing organization 
 facility'' means an OTC monograph drug facility where 
 neither the owner of such manufacturing facility nor 
 any affiliate of such owner or facility sells the OTC 
 monograph drug produced at such facility directly to 
 wholesalers, retailers, or consumers in the United 
 States.
 (3) The term ``costs of resources allocated for OTC 
 monograph drug activities'' means the expenses in 
 connection with OTC monograph drug activities for--
 (A) officers and employees of the Food and 
 Drug Administration, contractors of the Food 
 and Drug Administration, advisory committees, 
 and costs related to such officers, employees, 
 and committees and costs related to contracts 
 with such contractors;
 (B) management of information, and the 
 acquisition, maintenance, and repair of 
 computer resources;
 (C) leasing, maintenance, renovation, and 
 repair of facilities and acquisition, 
 maintenance, and repair of fixtures, furniture, 
 scientific equipment, and other necessary 
 materials and supplies; and
 (D) collecting fees under section 744M and 
 accounting for resources allocated for OTC 
 monograph drug activities.
 (4) The term ``FDA establishment identifier'' is the 
 unique number automatically generated by Food and Drug 
 Administration's Field Accomplishments and Compliance 
 Tracking System (FACTS) (or any successor system).
 (5) The term ``OTC monograph drug'' means a 
 nonprescription drug without an approved new drug 
 application which is governed by the provisions of 
 section 505G.
 (6) The term ``OTC monograph drug activities'' means 
 activities of the Secretary associated with OTC 
 monograph drugs and inspection of facilities associated 
 with such products, including the following activities:
 (A) The activities necessary for review and 
 evaluation of OTC monographs and OTC monograph 
 order requests, including--
 (i) orders proposing or finalizing 
 applicable conditions of use for OTC 
 monograph drugs;
 (ii) orders affecting status 
 regarding general recognition of safety 
 and effectiveness of an OTC monograph 
 ingredient or combination of 
 ingredients under specified conditions 
 of use;
 (iii) all OTC monograph drug 
 development and review activities, 
 including intra-agency collaboration;
 (iv) regulation and policy 
 development activities related to OTC 
 monograph drugs;
 (v) development of product standards 
 for products subject to review and 
 evaluation;
 (vi) meetings referred to in section 
 505G(i);
 (vii) review of labeling prior to 
 issuance of orders related to OTC 
 monograph drugs or conditions of use; 
 and
 (viii) regulatory science activities 
 related to OTC monograph drugs.
 (B) Inspections related to OTC monograph 
 drugs.
 (C) Monitoring of clinical and other research 
 conducted in connection with OTC monograph 
 drugs.
 (D) Safety activities with respect to OTC 
 monograph drugs, including--
 (i) collecting, developing, and 
 reviewing safety information on OTC 
 monograph drugs, including adverse 
 event reports;
 (ii) developing and using improved 
 adverse event data-collection systems, 
 including information technology 
 systems; and
 (iii) developing and using improved 
 analytical tools to assess potential 
 safety risks, including access to 
 external databases.
 (E) Other activities necessary for 
 implementation of section 505G.
 (7) The term ``OTC monograph order request'' means a 
 request for an order submitted under section 
 505G(b)(5).
 (8) The term ``Tier 1 OTC monograph order request'' 
 means any OTC monograph order request not determined to 
 be a Tier 2 OTC monograph order request.
 (9)(A) The term ``Tier 2 OTC monograph order 
 request'' means, subject to subparagraph (B), an OTC 
 monograph order request for--
 (i) the reordering of existing information in 
 the drug facts label of an OTC monograph drug;
 (ii) the addition of information to the other 
 information section of the drug facts label of 
 an OTC monograph drug, as limited by section 
 201.66(c)(7) of title 21, Code of Federal 
 Regulations (or any successor regulations);
 (iii) modification to the directions for use 
 section of the drug facts label of an OTC 
 monograph drug, if such changes conform to 
 changes made pursuant to section 505G(c)(3)(A);
 (iv) the standardization of the concentration 
 or dose of a specific finalized ingredient 
 within a particular finalized monograph;
 (v) a change to ingredient nomenclature to 
 align with nomenclature of a standards-setting 
 organization[; or];
 (vi) [addition] the addition of an 
 interchangeable term in accordance with section 
 330.1 of title 21, Code of Federal Regulations 
 (or any successor regulations)[.]; or
 (vii) the addition or modification of a 
 testing procedure applicable to one or more OTC 
 monograph drugs, provided that such additional 
 or modified testing procedure reflects a 
 voluntary consensus standard with respect to 
 pharmaceutical quality that is--
 (I) established by a national or 
 international standards development 
 organization; and
 (II) recognized by the Secretary 
 through a process described in guidance 
 for industry, initially published in 
 July 2023, or any successor guidance, 
 publicly available on the website of 
 the Food and Drug Administration, which 
 addresses voluntary consensus standards 
 for pharmaceutical quality.
 (B) The Secretary may, based on program 
 implementation experience or other factors found 
 appropriate by the Secretary, characterize any OTC 
 monograph order request as a Tier 2 OTC monograph order 
 request (including recharacterizing a request from Tier 
 1 to Tier 2) and publish such determination in a 
 proposed order issued pursuant to section 505G.
 (10)(A) The term ``OTC monograph drug facility'' 
 means a foreign or domestic business or other entity 
 that--
 (i) is--
 (I) under one management, either 
 direct or indirect; and
 (II) at one geographic location or 
 address engaged in manufacturing or 
 processing the finished dosage form of 
 an OTC monograph drug;
 (ii) includes a finished dosage form 
 manufacturer facility in a contractual 
 relationship with the sponsor of one or more 
 OTC monograph drugs to manufacture or process 
 such drugs; and
 (iii) does not include a business or other 
 entity whose only manufacturing or processing 
 activities are one or more of the following: 
 production of clinical research supplies, 
 testing, or placement of outer packaging on 
 packages containing multiple products, for such 
 purposes as creating multipacks, when each 
 monograph drug product contained within the 
 overpackaging is already in a final packaged 
 form prior to placement in the outer 
 overpackaging.
 (B) For purposes of subparagraph (A)(i)(II), separate 
 buildings or locations within close proximity are 
 considered to be at one geographic location or address 
 if the activities conducted in such buildings or 
 locations are--
 (i) closely related to the same business 
 enterprise;
 (ii) under the supervision of the same local 
 management; and
 (iii) under a single FDA establishment 
 identifier and capable of being inspected by 
 the Food and Drug Administration during a 
 single inspection.
 (C) If a business or other entity would meet criteria 
 specified in subparagraph (A), but for being under 
 multiple management, the business or other entity is 
 deemed to constitute multiple facilities, one per 
 management entity, for purposes of this paragraph.
 (11) The term ``OTC monograph drug meeting'' means 
 any meeting regarding the content of a proposed OTC 
 monograph order request.
 (12) The term ``person'' includes an affiliate of a 
 person.
 (13) The terms ``requestor'' and ``sponsor'' have the 
 meanings given such terms in section 505G.

SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONOGRAPH FEES.

 (a) Types of Fees.--Beginning with fiscal year 2021, the 
Secretary shall assess and collect fees in accordance with this 
section as follows:
 (1) Facility fee.--
 (A) In general.--[Each person]
 (i) Assessment of fees._Each person 
 that owns a facility identified as an 
 OTC monograph drug facility [on 
 December 31 of the fiscal year or at 
 any time during the preceding 12-month 
 period] at any time during the 
 applicable period specified in clause 
 (ii) for a fiscal year shall be 
 assessed an annual fee for each such 
 facility as determined under subsection 
 (c).
 (ii) Applicable period.--For purposes 
 of clause (i), the applicable period 
 is--
 (I) for fiscal year 2026, the 
 12-month period ending on 
 December 31, 2025;
 (II) for fiscal year 2027, 
 the 9-month period ending on 
 September 30, 2026; and
 (III) for fiscal year 2028 
 and each subsequent fiscal 
 year, the 12-month period 
 ending on September 30 of the 
 preceding fiscal year.
 (B) Exceptions.--
 (i) Facilities that cease 
 activities.--A fee shall not be 
 assessed under subparagraph (A) if the 
 identified OTC monograph drug 
 facility--
 [(I) has ceased all 
 activities related to OTC 
 monograph drugs prior to 
 December 31 of the year 
 immediately preceding the 
 applicable fiscal year; and]
 (I) has ceased all activities 
 related to OTC monograph drugs 
 prior to--
 (aa) for purposes of 
 fiscal year 2026, 
 January 1, 2025;
 (bb) for purposes of 
 fiscal year 2027, 
 January 1, 2026; and
 (cc) for purposes of 
 fiscal year 2028 and 
 each subsequent fiscal 
 year, October 1 of the 
 preceding fiscal year; 
 and
 (II) has updated its 
 registration to reflect such 
 change under the requirements 
 for drug establishment 
 registration set forth in 
 section 510.
 (ii) Contract manufacturing 
 organizations.--The amount of the fee 
 for a contract manufacturing 
 organization facility shall be equal to 
 two-thirds of the amount of the fee for 
 an OTC monograph drug facility that is 
 not a contract manufacturing 
 organization facility.
 (C) Amount.--The amount of fees established 
 under subparagraph (A) shall be established 
 under subsection (c).
 [(D) Due date.--
 [(i) For first program year.--For 
 fiscal year 2021, the facility fees 
 required under subparagraph (A) shall 
 be due on the later of--
 [(I) the first business day 
 of July of 2020; or
 [(II) 45 calendar days after 
 publication of the Federal 
 Register notice provided for 
 under subsection (c)(4)(A).
 [(ii) Subsequent fiscal years.--For 
 each fiscal year after fiscal year 
 2021, the facility fees required under 
 subparagraph (A) shall be due on the 
 later of--
 [(I) the first business day 
 of June of such year; or
 [(II) the first business day 
 after the enactment of an 
 appropriations Act providing 
 for the collection and 
 obligation of fees under this 
 section for such year.]
 (D) Due date.--
 (i) Fiscal year 2026.--For fiscal 
 year 2026, the facility fees required 
 under subparagraph (A) shall be due on 
 the later of--
 (I) the first business day of 
 June of such year; or
 (II) the first business day 
 after the enactment of an 
 appropriations Act providing 
 for the collection and 
 obligation of fees under this 
 section for such year.
 (ii) Fiscal year 2027.--For fiscal 
 year 2027, the facility fees required 
 under subparagraph (A) shall be due--
 (I) in a first installment 
 representing 50 percent of such 
 fee, on the later of--
 (aa) October 1, 2026; 
 or
 (bb) the first 
 business day after the 
 enactment of an 
 appropriations Act 
 providing for the 
 collection and 
 obligation of fees 
 under this section for 
 such year; and
 (II) in a second installment 
 representing the remaining 50 
 percent of such fee, on--
 (aa) February 1, 
 2027; or
 (bb) if an 
 appropriations Act 
 described in subclause 
 (I)(bb) is not in 
 effect on February 1, 
 2027, the first 
 business day after 
 enactment of such an 
 appropriations Act.
 (iii) Subsequent fiscal years.--For 
 fiscal year 2028 and each subsequent 
 fiscal year, the facility fees required 
 under subparagraph (A) shall be due on 
 the later of--
 (I) the first business day on 
 or after October 1 of the 
 fiscal year; or
 (II) the first business day 
 after the date of enactment of 
 an appropriations Act providing 
 for the collection and 
 obligation of fees under this 
 section for the fiscal year.
 (2) OTC monograph order request fee.--
 (A) In general.--Each person that submits an 
 OTC monograph order request shall be subject to 
 a fee for an OTC monograph order request. The 
 amount of such fee shall be--
 (i) for a Tier 1 OTC monograph order 
 request, $500,000, adjusted for 
 inflation for the fiscal year (as 
 determined under subsection (c)(1)(B)); 
 and
 (ii) for a Tier 2 OTC monograph order 
 request, $100,000, adjusted for 
 inflation for the fiscal year (as 
 determined under subsection (c)(1)(B)).
 (B) Due date.--The OTC monograph order 
 request fees required under subparagraph (A) 
 shall be due on the date of submission of the 
 OTC monograph order request.
 (C) Exception for certain safety changes.--A 
 person who is named as the requestor in an OTC 
 monograph order shall not be subject to a fee 
 under subparagraph (A) if the Secretary finds 
 that the OTC monograph order request seeks to 
 change the drug facts labeling of an OTC 
 monograph drug in a way that would add to or 
 strengthen--
 (i) a contraindication, warning, or 
 precaution;
 (ii) a statement about risk 
 associated with misuse or abuse; or
 (iii) an instruction about dosage and 
 administration that is intended to 
 increase the safe use of the OTC 
 monograph drug.
 (D) Refund of fee if order request is 
 recategorized as a tier 2 otc monograph order 
 request.--If the Secretary determines that an 
 OTC monograph request initially characterized 
 as Tier 1 shall be re-characterized as a Tier 2 
 OTC monograph order request, and the requestor 
 has paid a Tier 1 fee in accordance with 
 subparagraph (A)(i), the Secretary shall refund 
 the requestor the difference between the Tier 1 
 and Tier 2 fees determined under subparagraphs 
 (A)(i) and (A)(ii), respectively.
 (E) Refund of fee if order request refused 
 for filing or withdrawn before filing.--The 
 Secretary shall refund 75 percent of the fee 
 paid under subparagraph (B) for any order 
 request which is refused for filing or was 
 withdrawn before being accepted or refused for 
 filing.
 (F) Fees for order requests previously 
 refused for filing or withdrawn before 
 filing.--An OTC monograph order request that 
 was submitted but was refused for filing, or 
 was withdrawn before being accepted or refused 
 for filing, shall be subject to the full fee 
 under subparagraph (A) upon being resubmitted 
 or filed over protest.
 (G) Refund of fee if order request 
 withdrawn.--If an order request is withdrawn 
 after the order request was filed, the 
 Secretary may refund the fee or a portion of 
 the fee if no substantial work was performed on 
 the order request after the application was 
 filed. The Secretary shall have the sole 
 discretion to refund a fee or a portion of the 
 fee under this subparagraph. A determination by 
 the Secretary concerning a refund under this 
 subparagraph shall not be reviewable.
 (3) Refunds.--
 (A) In general.--Other than refunds provided 
 pursuant to any of subparagraphs (D) through 
 (G) of paragraph (2), the Secretary shall not 
 refund any fee paid under paragraph (1) except 
 as provided in subparagraph (B).
 (B) Disputes concerning fees.--To qualify for 
 the return of a fee claimed to have been paid 
 in error under paragraph (1) or (2), a person 
 shall submit to the Secretary a written request 
 justifying such return within 180 calendar days 
 after such fee was paid.
 (4) Notice.--Within the timeframe specified in 
 subsection (c), the Secretary shall publish in the 
 Federal Register the amount of the fees under paragraph 
 (1) for such fiscal year.
 [(b) Fee Revenue Amounts.--
 [(1) Fiscal year 2021.--For fiscal year 2021, 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 
 2021 (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 2022 through 2025, 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 2022.
 [(ii) $6,000,000 for fiscal year 
 2023.
 [(iii) $7,000,000 for fiscal year 
 2024.
 [(iv) $3,000,000 for fiscal year 
 2025.
 [(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 2021, $8,000,000; and
 [(B) for fiscal years 2022 through 2025, 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).]
 (b) Fee Revenue Amounts.--
 (1) In general.--For each of the fiscal years 2026 
 through 2030, 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 (2));
 (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));
 (E) an additional dollar amount equal to--
 (i) $2,373,000 for fiscal year 2026;
 (ii) $1,233,000 for fiscal year 2027; 
 and
 (iii) $854,000 for fiscal year 2028; 
 and
 (F) in the case of a fiscal year for which 
 the Secretary applies the one-time facility fee 
 workload adjustment under subsection (c)(4), 
 the dollar amount equal to such adjustment.
 (2) Annual base revenue.--For purposes of paragraph 
 (1), the dollar amount of the annual base revenue for a 
 fiscal year shall be--
 (A) for fiscal year 2026, the dollar amount 
 of the total revenue amount established for 
 fiscal year 2025 under this subsection as in 
 effect on the day before the date of enactment 
 of the Over-the-Counter Monograph Drug User Fee 
 Amendments, not including any adjustments made 
 for such fiscal year 2025 under subsection 
 (c)(2), as so in effect; and
 (B) for fiscal years 2027 through 2030, the 
 dollar amount of the total revenue amount 
 established under this subsection for the 
 previous fiscal year, not including any 
 adjustments made for such previous fiscal year 
 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)] subsection (b)(1)(B), the dollar 
 amount of the inflation adjustment to the 
 annual base revenue for [fiscal year 2022 and 
 each subsequent fiscal year] each fiscal year 
 shall be equal to the product of--
 (i) such annual base revenue for the 
 fiscal year under subsection (b)(2); 
 and
 (ii) the inflation adjustment 
 percentage under subparagraph (C).
 (B) OTC monograph order request fees.--For 
 purposes of subsection (a)(2), the dollar 
 amount of the inflation adjustment to the fee 
 for OTC monograph order requests for [fiscal 
 year 2022 and each subsequent fiscal year shall 
 be equal to the product of--] a fiscal year 
 shall be equal to the product of--
 [(i) the applicable fee under 
 subsection (a)(2) for the preceding 
 fiscal year; and
 [(ii) the inflation adjustment 
 percentage under subparagraph (C).]
 (i) for fiscal year 2026--
 (I) the fee for fiscal year 
 2025 under subsection (a)(2); 
 and
 (II) the inflation adjustment 
 percentage under subparagraph 
 (C); and
 (ii) for each of fiscal years 2027 
 through 2030--
 (I) the applicable fee under 
 subsection (a)(2) for the 
 preceding fiscal year; and
 (II) the inflation adjustment 
 percentage under subparagraph 
 (C).
 (C) Inflation adjustment percentage.--The 
 inflation adjustment percentage under this 
 subparagraph for a fiscal year is equal to the 
 sum of--
 [(i) for each of fiscal years 2022 
 and 2023, 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 2024 
 and 2025, the sum of--]
 [(I)] (i) the average annual percent 
 change in the cost, per full-time 
 equivalent position of the Food and 
 Drug Administration, of all personnel 
 compensation and benefits paid with 
 respect to such positions for the first 
 3 years of the preceding 4 fiscal 
 years, multiplied by the proportion of 
 personnel compensation and benefits 
 costs to total costs of OTC monograph 
 drug activities for the first 3 years 
 of the preceding 4 fiscal years; and
 [(II)] (ii) the average annual 
 percent change that occurred in the 
 Consumer Price Index for urban 
 consumers ([Washington-Baltimore, DC-
 MD-VA-WV] Washington-Arlington-
 Alexandria-DC-VA-MD-WV; Not Seasonally 
 Adjusted; All items; Annual Index) for 
 the first 3 years of the preceding 4 
 years of available data multiplied by 
 the proportion of all costs other than 
 personnel compensation and benefits 
 costs to total costs of OTC monograph 
 drug activities for the first 3 years 
 of the preceding 4 fiscal years.
 (2) Operating reserve adjustment.--
 (A) In general.--For [fiscal year 2021 and 
 subsequent fiscal years] each fiscal year, for 
 purposes of [subsections (b)(1)(B) and 
 (b)(2)(C)] subsection (b)(1)(C), the Secretary 
 may, in addition to adjustments under paragraph 
 (1), further increase the fee revenue and fees 
 if such an adjustment is necessary to provide 
 operating reserves of carryover user fees for 
 OTC monograph drug activities for not more than 
 [the number of weeks specified in subparagraph 
 (B)] 10 weeks.
 [(B) Number of weeks.--The number of weeks 
 specified in this subparagraph is--
 [(i) 3 weeks for fiscal year 2021;
 [(ii) 7 weeks for fiscal year 2022;
 [(iii) 10 weeks for fiscal year 2023;
 [(iv) 10 weeks for fiscal year 2024; 
 and
 [(v) 10 weeks for fiscal year 2025.]
 [(C)] (B) Decrease.--If the Secretary has 
 carryover balances for such process in excess 
 of 10 weeks of the operating reserves referred 
 to in subparagraph (A), the Secretary shall 
 decrease the fee revenue and fees referred to 
 in such subparagraph to provide for not more 
 than 10 weeks of such operating reserves.
 [(D)] (C) Rationale for adjustment.--If an 
 adjustment under this paragraph is made, the 
 rationale for the amount of the increase or 
 decrease (as applicable) in fee revenue and 
 fees shall be contained in the annual Federal 
 Register notice under [paragraph (4) 
 establishing] paragraph (5) publishing fee 
 revenue and fees for the fiscal year involved.
 (3) Additional direct cost adjustment.--The Secretary 
 shall, in addition to adjustments under paragraphs (1) 
 and (2), further increase the fee revenue and fees for 
 purposes of [subsection (b)(2)(D)] subsection (b)(1)(D) 
 by an amount equal to--
 [(A) $14,000,000 for fiscal year 2021;
 [(B) $7,000,000 for fiscal year 2022;
 [(C) $4,000,000 for fiscal year 2023;
 [(D) $3,000,000 for fiscal year 2024; and
 [(E) $3,000,000 for fiscal year 2025.]
 (A) $135,000 for fiscal year 2026;
 (B) $300,000 for fiscal year 2027;
 (C) $55,000 for fiscal year 2028;
 (D) $30,000 for fiscal year 2029; and
 (E) $0 for fiscal year 2030.
 [(4) Annual fee setting.--
 [(A) Fiscal year 2021.--The Secretary shall, 
 not later than the second Monday in May of 
 2020--
 [(i) establish OTC monograph drug 
 facility fees for fiscal year 2021 
 under subsection (a), based on the 
 revenue amount for such year under 
 subsection (b) and the adjustments 
 provided under this subsection; and
 [(ii) publish fee revenue, facility 
 fees, and OTC monograph order requests 
 in the Federal Register.
 [(B) Subsequent fiscal years.--The Secretary 
 shall, for each fiscal year that begins after 
 September 30, 2021, not later than the second 
 Monday in March that precedes such fiscal 
 year--
 [(i) establish for such fiscal year, 
 based on the revenue amounts under 
 subsection (b) and the adjustments 
 provided under this subsection--
 [(I) OTC monograph drug 
 facility fees under subsection 
 (a)(1); and
 [(II) OTC monograph order 
 request fees under subsection 
 (a)(2); and
 [(ii) publish such fee revenue 
 amounts, facility fees, and OTC 
 monograph order request fees in the 
 Federal Register.]
 (4) One-time facility fee workload adjustment.--
 (A) In general.--In addition to the 
 adjustments under paragraphs (1), (2), and (3), 
 the Secretary may further increase the fee 
 revenues and fees through a one-time adjustment 
 made for fiscal year 2028, 2029, or 2030, in 
 accordance with this paragraph.
 (B) Adjustment described.--
 (i) Conditions for adjustment.--An 
 adjustment under this paragraph may be 
 made for a fiscal year only if--
 (I) an adjustment under this 
 paragraph had not been made for 
 any prior fiscal year;
 (II) the average number of 
 OTC monograph drug facilities 
 subject to a facility fee under 
 subsection (a)(1) over the 
 period of the preceding 3 
 fiscal years exceeds 1,625; and
 (III) with respect to 
 facilities described in 
 subclause (II), the average 
 number of such facilities 
 (expressed as a percentage) 
 that appeared on the arrears 
 lists pursuant to subsection 
 (e)(1)(A)(i) over the period of 
 the preceding 3 fiscal years is 
 less than 30 percent.
 (ii) Amount of adjustment.--An 
 adjustment under this paragraph for a 
 fiscal year shall equal the product 
 of--
 (I) the total facility 
 revenue amount determined under 
 subsection (b) for the fiscal 
 year, exclusive of the 
 adjustment under this paragraph 
 for such fiscal year; and
 (II) the excess facility 
 percentage described in clause 
 (iii).
 (iii) Excess facility percentage.--
 The excess facility percentage 
 described in this clause is--
 (I) the amount by which the 
 average number of OTC monograph 
 drug facilities subject to a 
 facility fee under subsection 
 (a)(1) over the preceding 3 
 fiscal years exceeds 1,625; 
 divided by
 (II) 1,625.
 (5) Annual fee setting.--The Secretary shall, not 
 later than 60 days before the first day of each fiscal 
 year--
 (A) establish for such fiscal year, based on 
 the revenue amounts under subsection (b) and 
 the adjustments provided under this 
 subsection--
 (i) OTC monograph drug facility fees 
 under subsection (a)(1); and
 (ii) OTC monograph order request fees 
 under subsection (a)(2); and
 (B) publish such fee revenue amounts, 
 facility fees, and OTC monograph order request 
 fees in the Federal Register.
 (d) Identification of Facilities.--Each person that owns an 
OTC monograph drug facility shall submit to the Secretary the 
information required under this subsection each year. Such 
information shall, for each fiscal year--
 (1) be submitted as part of the requirements for drug 
 establishment registration set forth in section 510; 
 and
 (2) include for each such facility, at a minimum, 
 identification of the facility's business operation as 
 that of an OTC monograph drug facility.
 (e) Effect of Failure to Pay Fees.--
 (1) OTC monograph drug facility fee.--
 (A) In general.--Failure to pay the fee under 
 subsection (a)(1) within 20 calendar days of 
 the due date as specified in subparagraph (D) 
 of such subsection shall result in the 
 following:
 (i) The Secretary shall place the 
 facility on a publicly available 
 arrears list.
 (ii) All OTC monograph drugs 
 manufactured in such a facility or 
 containing an ingredient manufactured 
 in such a facility shall be deemed 
 misbranded under section 502(ff).
 (B) Application of penalties.--The penalties 
 under this paragraph shall apply until the fee 
 established by subsection (a)(1) is paid.
 (2) Order requests.--An OTC monograph order request 
 submitted by a person subject to fees under subsection 
 (a) shall be considered incomplete and shall not be 
 accepted for filing by the Secretary until all fees 
 owed by such person under this section have been paid.
 (3) Meetings.--A person subject to fees under this 
 section shall be considered ineligible for OTC 
 monograph drug meetings until all such fees owed by 
 such person have been paid.
 (f) Crediting and Availability of Fees.--
 (1) In general.--Fees authorized under subsection (a) 
 shall be collected and available for obligation only to 
 the extent and in the amount provided in advance in 
 appropriations Acts. Such fees are authorized to remain 
 available until expended. Such sums as may be necessary 
 may be transferred from the Food and Drug 
 Administration salaries and expenses appropriation 
 account without fiscal year limitation to such 
 appropriation account for salaries and expenses with 
 such fiscal year limitation. The sums transferred shall 
 be available solely for OTC monograph drug activities.
 (2) Collections and appropriation acts.--
 (A) In general.--Subject to subparagraph (C), 
 the fees authorized by this section shall be 
 collected and available in each fiscal year in 
 an amount not to exceed the amount specified in 
 appropriation Acts, or otherwise made available 
 for obligation, for such fiscal year.
 (B) Use of fees and limitation.--The fees 
 authorized by this section shall be available 
 to defray increases in the costs of the 
 resources allocated for OTC monograph drug 
 activities (including increases in such costs 
 for an additional number of full-time 
 equivalent positions in the Department of 
 Health and Human Services to be engaged in such 
 activities), only if the Secretary allocates 
 for such purpose an amount for such fiscal year 
 (excluding amounts from fees collected under 
 this section) no less than $12,000,000, 
 multiplied by the adjustment factor applicable 
 to the fiscal year involved under subsection 
 (c)(1).
 (C) Compliance.--The Secretary shall be 
 considered to have met the requirements of 
 subparagraph (B) in any fiscal year if the 
 costs funded by appropriations and allocated 
 for OTC monograph drug activities are not more 
 than 15 percent below the level specified in 
 such subparagraph.
 (D) Provision for early payments [in 
 subsequent years].--Payment of fees authorized 
 under this section for a fiscal year [(after 
 fiscal year 2021)], 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 [2021 through 2025] 2026 through 2030, 
 there is authorized to be appropriated for fees under 
 this section an amount equal to the total amount of 
 fees assessed for such fiscal year under this section.
 (g) Collection of Unpaid Fees.--In any case where the 
Secretary does not receive payment of a fee assessed under 
subsection (a) within 30 calendar days after it is due, such 
fee shall be treated as a claim of the United States Government 
subject to subchapter II of chapter 37 of title 31, United 
States Code.
 (h) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in OTC monograph 
drug activities, be reduced to offset the number of officers, 
employees, and advisory committees so engaged.

SEC. 744N. REAUTHORIZATION; REPORTING REQUIREMENTS.

 (a) Performance Report.--[Beginning with fiscal year 2021, 
and not later than 120 calendar days after the end of each 
fiscal year thereafter] Not later than 120 calendar days after 
the end of each fiscal year for which fees are collected under 
this part, the Secretary shall prepare and submit to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report concerning the progress of 
the Food and Drug Administration in achieving the goals 
identified in the letters described in [section 3861(b) of the 
CARES Act] section 2 of the Over-the-Counter Monograph Drug 
User Fee Amendments 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 2021 and each subsequent fiscal year] 
each fiscal year for which fees are collected under this part, 
the Secretary shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the 
Senate a report on the implementation of the authority for such 
fees during such fiscal year and the use, by the Food and Drug 
Administration, of the fees collected for such fiscal year.
 (c) Public Availability.--The Secretary shall make the 
reports required under subsections (a) and (b) available to the 
public on the internet website of the Food and Drug 
Administration.
 (d) Reauthorization.--
 (1) Consultation.--In developing recommendations to 
 present to the Congress with respect to the goals 
 described in subsection (a), and plans for meeting the 
 goals, for OTC monograph drug activities for the first 
 5 fiscal years after fiscal year [2025] 2030, and for 
 the reauthorization of this part for such fiscal years, 
 the Secretary shall consult with--
 (A) the Committee on Energy and Commerce of 
 the House of Representatives;
 (B) the Committee on Health, Education, 
 Labor, and Pensions of the Senate;
 (C) scientific and academic experts;
 (D) health care professionals;
 (E) representatives of patient and consumer 
 advocacy groups; and
 (F) the regulated industry.
 (2) Public review of recommendations.--After 
 negotiations with the regulated industry, the Secretary 
 shall--
 (A) present the recommendations developed 
 under paragraph (1) to the congressional 
 committees specified in such paragraph;
 (B) publish such recommendations in the 
 Federal Register;
 (C) provide for a period of 30 calendar days 
 for the public to provide written comments on 
 such recommendations;
 (D) hold a meeting at which the public may 
 present its views on such recommendations; and
 (E) after consideration of such public views 
 and comments, revise such recommendations as 
 necessary.
 (3) Transmittal of recommendations.--Not later than 
 January 15, [2025] 2030, the Secretary shall transmit 
 to the Congress the revised recommendations under 
 paragraph (2), a summary of the views and comments 
 received under such paragraph, and any changes made to 
 the recommendations in response to such views and 
 comments.

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