115TH CONGRESS 

2D SESSION H. R. 5333 

AN ACT 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Over-the-Counter 

3 Monograph Safety, Innovation, and Reform Act of 2018’’. 

4 TITLE I—OTC DRUG REVIEW 

5 SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 

6 DRUGS THAT ARE MARKETED WITHOUT AN 

7 APPROVED NEW DRUG APPLICATION. 

8 (a) IN GENERAL.—Chapter V of the Federal Food, 

9 Drug, and Cosmetic Act is amended by inserting after sec10 tion 505F of such Act (21 U.S.C. 355g) the following: 

11 ‘‘SEC. 505G. REGULATION OF CERTAIN NONPRESCRIPTION 

12 DRUGS THAT ARE MARKETED WITHOUT AN 

13 APPROVED NEW DRUG APPLICATION. 

14 ‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH15 OUT AN APPROVED APPLICATION.—Nonprescription 

16 drugs marketed without an approved new drug application 

17 under section 505, as of the date of the enactment of the 

18 Over-the-Counter Monograph Safety, Innovation, and Re19 form Act of 2018, shall be treated in accordance with this 

20 subsection. 

21 ‘‘(1) DRUGS SUBJECT TO A FINAL MONOGRAPH; 

22 CATEGORY I DRUGS SUBJECT TO A TENTATIVE

23 FINAL MONOGRAPH.—A drug is deemed to be gen24 erally recognized as safe and effective within the 

25 meaning of section 201(p)(1), not a new drug under 
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1 section 201(p), and not subject to section 503(b)(1), 

2 if— 

3 ‘‘(A) the drug is— 

4 ‘‘(i) in conformity with the require5 ments for nonprescription use of a final 

6 monograph issued under part 330 of title 

7 21, Code of Federal Regulations (except as 

8 provided in paragraph (2)), the general re9 quirements for nonprescription drugs, and 

10 requirements under subsections (b), (c), 

11 and (k); and 

12 ‘‘(ii) except as permitted by an order 

13 issued under subsection (b) or, in the case 

14 of a minor change in the drug, in con15 formity with an order issued under sub16 section (c), in a dosage form that, imme17 diately prior to the date of the enactment 

18 of this section, has been used to a material 

19 extent and for a material time within the 

20 meaning of section 201(p)(2); or 

21 ‘‘(B) the drug is— 

22 ‘‘(i) classified in category I for safety 

23 and effectiveness under a tentative final 

24 monograph that is the most recently appli25 cable proposal or determination issued 
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1 under part 330 of title 21, Code of Federal 

2 Regulations; 

3 ‘‘(ii) in conformity with the proposed 

4 requirements for nonprescription use of 

5 such tentative final monograph, any appli6 cable subsequent determination by the Sec7 retary, the general requirements for non8 prescription drugs, and requirements under 

9 subsections (b), (c), and (k); and 

10 ‘‘(iii) except as permitted by an order 

11 issued under subsection (b) or, in the case 

12 of a minor change in the drug, in con13 formity with an order issued under sub14 section (c), in a dosage form that, imme15 diately prior to the date of the enactment 

16 of this section, has been used to a material 

17 extent and for a material time within the 

18 meaning of section 201(p)(2). 

19 ‘‘(2) TREATMENT OF SUNSCREEN DRUGS.— 

20 With respect to sunscreen drugs subject to this sec21 tion, the applicable requirements shall be the re22 quirements specified in part 352 of title 21, Code of 

23 Federal Regulations, as published on May 21, 1999, 

24 beginning on page 27687 of volume 64 of the Fed25 eral Register, except that the applicable require-
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1 ments governing effectiveness and labeling shall be 

2 those specified in section 201.327 of title 21, Code 

3 of Federal Regulations, subject to the requirements 

4 of subsections (b), (c), and (k). 

5 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN6 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS

7 SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE

8 NOTICE OF PROPOSED RULEMAKING.—A drug that 

9 is not described in paragraphs (1), (2), or (4) is not 

10 required to be the subject of an application approved 

11 under section 505, and is not subject to section 

12 503(b)(1), if— 

13 ‘‘(A) the drug is— 

14 ‘‘(i) classified in category III for safe15 ty or effectiveness in the preamble of a 

16 proposed rule establishing a tentative final 

17 monograph that is the most recently appli18 cable proposal or determination for such 

19 drug issued under part 330 of title 21, 

20 Code of Federal Regulations; 

21 ‘‘(ii) in conformity with— 

22 ‘‘(I) the conditions of use, includ23 ing indication and dosage strength, if 

24 any, described for such category III 
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1 drug in such preamble or in an appli2 cable subsequent proposed rule; 

3 ‘‘(II) the proposed requirements 

4 for drugs classified in such tentative 

5 final monograph in category I in the 

6 most recently proposed rule estab7 lishing requirements related to such 

8 tentative final monograph and in any 

9 final rule establishing requirements 

10 that are applicable to the drug; and 

11 ‘‘(III) the general requirements 

12 for nonprescription drugs and require13 ments under subsections (b) or (k); 

14 and 

15 ‘‘(iii) in a dosage form that, imme16 diately prior to the date of the enactment 

17 of this section, was not required to have 

18 satisfied the requirements of section 

19 330.14 of title 21, Code of Federal Regula20 tions (as in effect at that time), in order 

21 for such drug to be lawfully marketed 

22 without an application approved under sec23 tion 505; or 

24 ‘‘(B) the drug is— 
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1 ‘‘(i) classified in category I for safety 

2 and effectiveness under a proposed mono3 graph or advance notice of proposed rule4 making that is the most recently applicable 

5 proposal or determination for such drug 

6 issued under part 330 of title 21, Code of 

7 Federal Regulations; 

8 ‘‘(ii) in conformity with the require9 ments for nonprescription use of such pro10 posed monograph or advance notice of pro11 posed rulemaking, any applicable subse12 quent determination by the Secretary, the 

13 general requirements for nonprescription 

14 drugs, and requirements under subsections 

15 (b) or (k); and 

16 ‘‘(iii) in a dosage form that, imme17 diately prior to the date of the enactment 

18 of this section, has been used to a material 

19 extent and for a material time within the 

20 meaning of section 201(p)(2). 

21 ‘‘(4) CATEGORY II DRUGS DEEMED NEW

22 DRUGS.—A drug that is classified in category II for 

23 safety or effectiveness under a tentative final mono24 graph or that is subject to a determination to be not 

25 safe or effective in a proposed rule that is the most 
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1 recently applicable proposal issued under part 330 of 

2 title 21, Code of Federal Regulations, shall be 

3 deemed to be a new drug within the meaning of sec4 tion 201(p), misbranded under section 502(ee), and 

5 subject to the requirement for an approved new drug 

6 application under section 505 beginning on the day 

7 that is 180 calendar days after the date of the en8 actment of this section, unless, before such day, the 

9 Secretary determines that it is in the interest of 

10 public health to extend the period during which the 

11 drug may be marketed without such an approved 

12 new drug application. 

13 ‘‘(5) DRUGS NOT GRASE DEEMED NEW

14 DRUGS.—A drug that the Secretary has determined 

15 not to be generally recognized as safe and effective 

16 within the meaning of section 201(p)(1) under a 

17 final determination issued under part 330 of title 

18 21, Code of Federal Regulations, shall be deemed to 

19 be a new drug within the meaning of section 201(p), 

20 misbranded under section 502(ee), and subject to 

21 the requirement for an approved new drug applica22 tion under section 505. 

23 ‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.— 

24 Except as provided in subsection (m), a drug is 

25 deemed to be a new drug within the meaning of sec-
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1 tion 201(p) and misbranded under section 502(ee) if 

2 the drug— 

3 ‘‘(A) is not subject to section 503(b)(1); 

4 and 

5 ‘‘(B) is not described in paragraphs (1), 

6 (2), (3), (4), or (5), or subsection (b)(1)(B). 

7 ‘‘(b) ADMINISTRATIVE ORDERS.— 

8 ‘‘(1) IN GENERAL.— 

9 ‘‘(A) DETERMINATION.—The Secretary 

10 may, on the initiative of the Secretary or at the 

11 request of one or more requestors, issue admin12 istrative orders determining whether there are 

13 conditions under which specific drugs, classes of 

14 such drugs, or combinations of such drugs are 

15 determined to be— 

16 ‘‘(i) not subject to section 503(b)(1); 

17 and 

18 ‘‘(ii) generally recognized as safe and 

19 effective within the meaning of section 

20 201(p)(1). 

21 ‘‘(B) EFFECT.—A drug or combination of 

22 drugs shall be deemed to not require approval 

23 under section 505 if such drug or combination 

24 of drugs— 
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1 ‘‘(i) is determined by the Secretary to 

2 meet the conditions specified in clauses (i) 

3 and (ii) of subparagraph (A); 

4 ‘‘(ii) is marketed in conformity with 

5 an administrative order under this sub6 section; 

7 ‘‘(iii) meets the general requirements 

8 for nonprescription drugs; and 

9 ‘‘(iv) meets the requirements under 

10 subsections (c) and (k). 

11 ‘‘(C) STANDARD.—The Secretary shall find 

12 that a drug is not generally recognized as safe 

13 and effective within the meaning of section 

14 201(p)(1) if— 

15 ‘‘(i) the evidence shows that the drug 

16 is not generally recognized as safe and ef17 fective within the meaning of section 

18 201(p)(1); or 

19 ‘‘(ii) the evidence is inadequate to 

20 show that the drug is generally recognized 

21 as safe and effective within the meaning of 

22 section 201(p)(1). 

23 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY

24 THE SECRETARY.— 
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1 ‘‘(A) IN GENERAL.—In issuing an adminis2 trative order under paragraph (1) upon the 

3 Secretary’s initiative, the Secretary shall— 

4 ‘‘(i) make reasonable efforts to notify 

5 informally, not later than 2 business days 

6 before the issuance of the proposed order, 

7 the sponsors of drugs who have a listing in 

8 effect under section 510(j) for the drugs or 

9 combination of drugs that will be subject 

10 to the administrative order; 

11 ‘‘(ii) after any such reasonable efforts 

12 of notification— 

13 ‘‘(I) issue a proposed administra14 tive order by publishing it on the 

15 website of the Food and Drug Admin16 istration and include in such order the 

17 reasons for the issuance of such order; 

18 and 

19 ‘‘(II) publish a notice of avail20 ability of such proposed order in the 

21 Federal Register; 

22 ‘‘(iii) except as provided in subpara23 graph (B), provide for a public comment 

24 period with respect to such proposed order 

25 of not less than 45 calendar days; and 
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1 ‘‘(iv) if, after completion of the pro2 ceedings specified in clauses (i) through 

3 (iii), the Secretary determines that it is ap4 propriate to issue a final administrative 

5 order— 

6 ‘‘(I) issue the final administrative 

7 order, together with a detailed state8 ment of reasons, which order shall not 

9 take effect until the time for request10 ing judicial review under paragraph 

11 (3)(D)(ii) has expired; 

12 ‘‘(II) publish a notice of such 

13 final administrative order in the Fed14 eral Register; 

15 ‘‘(III) afford requestors of drugs 

16 that will be subject to such order the 

17 opportunity for formal dispute resolu18 tion up to the level of the Director of 

19 the Center for Drug Evaluation and 

20 Research, which initially must be re21 quested within 45 calendar days of 

22 the issuance of the order, and, for 

23 subsequent levels of appeal, within 30 

24 calendar days of the prior decision; 

25 and 
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1 ‘‘(IV) except with respect to 

2 drugs described in paragraph (3)(B), 

3 upon completion of the formal dispute 

4 resolution procedure, inform the per5 sons which sought such dispute reso6 lution of their right to request a hear7 ing. 

8 ‘‘(B) EXCEPTIONS.—When issuing an ad9 ministrative order under paragraph (1) on the 

10 Secretary’s initiative proposing to determine 

11 that a drug described in subsection (a)(3) is not 

12 generally recognized as safe and effective within 

13 the meaning of section 201(p)(1), the Secretary 

14 shall follow the procedures in subparagraph 

15 (A), except that— 

16 ‘‘(i) the proposed order shall include 

17 notice of— 

18 ‘‘(I) the general categories of 

19 data the Secretary has determined 

20 necessary to establish that the drug is 

21 generally recognized as safe and effec22 tive within the meaning of section 

23 201(p)(1); and 

24 ‘‘(II) the format for submissions 

25 by interested persons; 
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1 ‘‘(ii) the Secretary shall provide for a 

2 public comment period of no less than 180 

3 calendar days with respect to such pro4 posed order, except when the Secretary de5 termines, for good cause, that a shorter pe6 riod is in the interests of public health; 

7 and 

8 ‘‘(iii) any person who submits data in 

9 such comment period shall include a cer10 tification that the person has submitted all 

11 evidence created, obtained, or received by 

12 that person that is both within the cat13 egories of data identified in the proposed 

14 order and relevant to a determination as to 

15 whether the drug is generally recognized as 

16 safe and effective within the meaning of 

17 section 201(p)(1). 

18 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

19 ‘‘(A) IN GENERAL.—Only a person who 

20 participated in each stage of formal dispute res21 olution under subclause (III) of paragraph 

22 (2)(A)(iv) of an administrative order with re23 spect to a drug may request a hearing con24 cerning a final administrative order issued 

25 under such paragraph with respect to such 
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1 drug. Such person must submit a request for a 

2 hearing, which shall be based solely on informa3 tion in the administrative record, to the Sec4 retary not later than 30 calendar days after re5 ceiving notice of the final decision of the formal 

6 dispute resolution procedure. 

7 ‘‘(B) NO HEARING REQUIRED WITH RE8 SPECT TO ORDERS RELATING TO CERTAIN

9 DRUGS.— 

10 ‘‘(i) IN GENERAL.—The Secretary 

11 shall not be required to provide notice and 

12 an opportunity for a hearing pursuant to 

13 paragraph (2)(A)(iv) if the final adminis14 trative order involved relates to a drug— 

15 ‘‘(I) that is described in sub16 section (a)(3)(A); and 

17 ‘‘(II) with respect to which no 

18 human or non-human data studies rel19 evant to the safety or effectiveness of 

20 such drug have been submitted to the 

21 administrative record since the 

22 issuance of the most recent tentative 

23 final monograph relating to such 

24 drug. 
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1 ‘‘(ii) HUMAN DATA STUDIES AND

2 NON-HUMAN DATA DEFINED.—In this sub3 paragraph: 

4 ‘‘(I) The term ‘human data stud5 ies’ means clinical trials of safety or 

6 effectiveness (including actual use 

7 studies), pharmacokinetics studies, or 

8 bioavailability studies. 

9 ‘‘(II) The term ‘non-human data’ 

10 means data from testing other than 

11 with human subjects which provides 

12 information concerning safety or ef13 fectiveness. 

14 ‘‘(C) HEARING PROCEDURES.— 

15 ‘‘(i) DENIAL OF REQUEST FOR HEAR16 ING.—If the Secretary determines that in17 formation submitted in a request for a 

18 hearing under subparagraph (A) with re19 spect to a final administrative order issued 

20 under paragraph (2)(A)(iv), does not iden21 tify the existence of a genuine and sub22 stantial question of material fact, the Sec23 retary may deny such request. In making 

24 such a determination, the Secretary may 

25 consider only information and data that 
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1 are based on relevant and reliable scientific 

2 principles and methodologies. 

3 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

4 RELATED REQUESTS.—If more than one 

5 request for a hearing is submitted with re6 spect to the same administrative order 

7 under subparagraph (A), the Secretary 

8 may direct that a single hearing be con9 ducted in which all persons whose hearing 

10 requests were granted may participate. 

11 ‘‘(iii) PRESIDING OFFICER.—The pre12 siding officer of a hearing requested under 

13 subparagraph (A) shall— 

14 ‘‘(I) be designated by the Sec15 retary; 

16 ‘‘(II) not be an employee of the 

17 Center for Drug Evaluation and Re18 search; and 

19 ‘‘(III) not have been previously 

20 involved in the development of the ad21 ministrative order involved or pro22 ceedings relating to that administra23 tive order. 

24 ‘‘(iv) RIGHTS OF PARTIES TO HEAR25 ING.—The parties to a hearing requested 
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1 under subparagraph (A) shall have the 

2 right to present testimony, including testi3 mony of expert witnesses, and to cross-ex4 amine witnesses presented by other parties. 

5 Where appropriate, the presiding officer 

6 may require that cross-examination by par7 ties representing substantially the same in8 terests be consolidated to promote effi9 ciency and avoid duplication. 

10 ‘‘(v) FINAL DECISION.— 

11 ‘‘(I) At the conclusion of a hear12 ing requested under subparagraph 

13 (A), the presiding officer of the hear14 ing shall issue a decision containing 

15 findings of fact and conclusions of 

16 law. The decision of the presiding offi17 cer shall be final. 

18 ‘‘(II) The final decision may not 

19 take effect until the period under sub20 paragraph (D)(ii) for submitting a re21 quest for judicial review of such deci22 sion expires. 

23 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN24 ISTRATIVE ORDER.— 
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1 ‘‘(i) IN GENERAL.—The procedures 

2 described in section 505(h) shall apply 

3 with respect to judicial review of final ad4 ministrative orders issued under this sub5 section in the same manner and to the 

6 same extent as such section applies to an 

7 order described in such section except that 

8 the judicial review shall be taken by filing 

9 in an appropriate district court of the 

10 United States in lieu of the appellate 

11 courts specified in such section. 

12 ‘‘(ii) PERIOD TO SUBMIT A REQUEST

13 FOR JUDICIAL REVIEW.—A person eligible 

14 to request a hearing under this paragraph 

15 and seeking judicial review of a final ad16 ministrative order issued under this sub17 section shall file such request for judicial 

18 review not later than 60 calendar days 

19 after the latest of— 

20 ‘‘(I) the date on which notice of 

21 such order is published; 

22 ‘‘(II) the date on which a hearing 

23 with respect to such order is denied 

24 under subparagraph (B) or (C)(i); 
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1 ‘‘(III) the date on which a final 

2 decision is made following a hearing 

3 under subparagraph (C)(v); or 

4 ‘‘(IV) if no hearing is requested, 

5 the date on which the time for re6 questing a hearing expires. 

7 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT

8 TO ADMINISTRATIVE ORDERS INITIATED BY THE

9 SECRETARY.— 

10 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

11 HEALTH.— 

12 ‘‘(i) IN GENERAL.—In the case of a 

13 determination by the Secretary that a 

14 drug, class of drugs, or combination of 

15 drugs subject to this section poses an im16 minent hazard to the public health, the 

17 Secretary, after first making reasonable ef18 forts to notify, not later than 48 hours be19 fore issuance of such order under this sub20 paragraph, sponsors who have a listing in 

21 effect under section 510(j) for such drug 

22 or combination of drugs— 

23 ‘‘(I) may issue an interim final 

24 administrative order for such drug, 

25 class of drugs, or combination of 
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1 drugs under paragraph (1), together 

2 with a detailed statement of the rea3 sons for such order; 

4 ‘‘(II) shall publish in the Federal 

5 Register a notice of availability of any 

6 such order; and 

7 ‘‘(III) shall provide for a public 

8 comment period of at least 45 cal9 endar days with respect to such in10 terim final order. 

11 ‘‘(ii) NONDELEGATION.—The Sec12 retary may not delegate the authority to 

13 issue an interim final administrative order 

14 under this subparagraph. 

15 ‘‘(B) SAFETY LABELING CHANGES.— 

16 ‘‘(i) IN GENERAL.—In the case of a 

17 determination by the Secretary that a 

18 change in the labeling of a drug, class of 

19 drugs, or combination of drugs subject to 

20 this section is reasonably expected to miti21 gate a significant or unreasonable risk of 

22 a serious adverse event associated with use 

23 of the drug, the Secretary may— 

24 ‘‘(I) make reasonable efforts to 

25 notify informally, not later than 48 
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1 hours before the issuance of the in2 terim final order, the sponsors of 

3 drugs who have a listing in effect 

4 under section 510(j) for such drug or 

5 combination of drugs; 

6 ‘‘(II) after reasonable efforts of 

7 notification, issue an interim final ad8 ministrative order in accordance with 

9 paragraph (1) to require such change, 

10 together with a detailed statement of 

11 the reasons for such order; 

12 ‘‘(III) publish in the Federal 

13 Register a notice of availability of 

14 such order; and 

15 ‘‘(IV) provide for a public com16 ment period of at least 45 calendar 

17 days with respect to such interim final 

18 order. 

19 ‘‘(ii) CONTENT OF ORDER.—An in20 terim final order issued under this sub21 paragraph with respect to the labeling of a 

22 drug may provide for new warnings and 

23 other information required for safe use of 

24 the drug. 
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1 ‘‘(C) EFFECTIVE DATE.—An order under 

2 subparagraph (A) or (B) shall take effect on a 

3 date specified by the Secretary. 

4 ‘‘(D) FINAL ORDER.—After the completion 

5 of the proceedings in subparagraph (A) or (B), 

6 the Secretary shall— 

7 ‘‘(i) issue a final order in accordance 

8 with paragraph (1); 

9 ‘‘(ii) publish a notice of availability of 

10 such final administrative order in the Fed11 eral Register; and 

12 ‘‘(iii) afford sponsors of such drugs 

13 that will be subject to such an order the 

14 opportunity for formal dispute resolution 

15 up to the level of the Director of the Cen16 ter for Drug Evaluation and Research, 

17 which must initially be within 45 calendar 

18 days of the issuance of the order, and for 

19 subsequent levels of appeal, within 30 cal20 endar days of the prior decision. 

21 ‘‘(E) HEARINGS.—A sponsor of a drug 

22 subject to a final order issued under subpara23 graph (D) and that participated in each stage 

24 of formal dispute resolution under clause (iii) of 

25 such subparagraph may request a hearing on 
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1 such order. The provisions of subparagraphs 

2 (A), (B), and (C) of paragraph (3), other than 

3 paragraph (3)(C)(v)(II), shall apply with re4 spect to a hearing on such order in the same 

5 manner and to the same extent as such provi6 sions apply with respect to a hearing on an ad7 ministrative order issued under paragraph 

8 (2)(A)(iv). 

9 ‘‘(F) TIMING.— 

10 ‘‘(i) FINAL ORDER AND HEARING.— 

11 The Secretary shall— 

12 ‘‘(I) not later than 6 months 

13 after the date on which the comment 

14 period closes under subparagraph (A) 

15 or (B), issue a final order in accord16 ance with paragraph (1); and 

17 ‘‘(II) not later than 12 months 

18 after the date on which such final 

19 order is issued, complete any hearing 

20 under subparagraph (E). 

21 ‘‘(ii) DISPUTE RESOLUTION RE22 QUEST.—The Secretary shall specify in an 

23 interim final order issued under subpara24 graph (A) or (B) such shorter periods for 

25 requesting dispute resolution under sub-
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1 paragraph (D)(iii) as are necessary to 

2 meet the requirements of this subpara3 graph. 

4 ‘‘(G) JUDICIAL REVIEW.—A final order 

5 issued pursuant to subparagraph (F) shall be 

6 subject to judicial review in accordance with 

7 paragraph (3)(D). 

8 ‘‘(5) ADMINISTRATIVE ORDER INITIATED AT

9 THE REQUEST OF A REQUESTOR.— 

10 ‘‘(A) IN GENERAL.—In issuing an adminis11 trative order under paragraph (1) at the re12 quest of a requestor with respect to certain 

13 drugs, classes of drugs, or combinations of 

14 drugs— 

15 ‘‘(i) the Secretary shall, after receiv16 ing a request under this subparagraph, de17 termine whether the request is sufficiently 

18 complete and formatted to permit a sub19 stantive review; 

20 ‘‘(ii) if the Secretary determines that 

21 the request is sufficiently complete and for22 matted to permit a substantive review, the 

23 Secretary shall— 

24 ‘‘(I) file the request; and 
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1 ‘‘(II) initiate proceedings with re2 spect to issuing an administrative 

3 order in accordance with paragraphs 

4 (2) and (3); and 

5 ‘‘(iii) except as provided in paragraph 

6 (6), if the Secretary determines that a re7 quest does not meet the requirements for 

8 filing or is not sufficiently complete and 

9 formatted to permit a substantive review, 

10 the requestor may demand that the request 

11 be filed over protest, and the Secretary 

12 shall initiate proceedings to review the re13 quest in accordance with paragraph (2)(A). 

14 ‘‘(B) REQUEST TO INITIATE PRO15 CEEDINGS.— 

16 ‘‘(i) IN GENERAL.—A requestor seek17 ing an administrative order under para18 graph (1) with respect to certain drugs, 

19 classes of drugs, or combinations of drugs, 

20 shall submit to the Secretary a request to 

21 initiate proceedings for such order in the 

22 form and manner as specified by the Sec23 retary. Such requestor may submit a re24 quest under this subparagraph for the 

25 issuance of an administrative order— 
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1 ‘‘(I) determining whether a drug 

2 is generally recognized as safe and ef3 fective within the meaning of section 

4 201(p)(1), exempt from section 

5 503(b)(1), and not required to be the 

6 subject of an approved application 

7 under section 505; or 

8 ‘‘(II) determining whether a 

9 change to a condition of use of a drug 

10 is generally recognized as safe and ef11 fective within the meaning of section 

12 201(p)(1), exempt from section 

13 503(b)(1), and not required to be the 

14 subject of an approved application 

15 under section 505, if, absent such a 

16 changed condition of use, such drug 

17 is— 

18 ‘‘(aa) generally recognized 

19 as safe and effective within the 

20 meaning of section 201(p)(1) in 

21 accordance with subsection 

22 (a)(1), (a)(2), or an order under 

23 this subsection; or 

24 ‘‘(bb) subject to subsection 

25 (a)(3), but only if such requestor 
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1 initiates such request in conjunc2 tion with a request for the Sec3 retary to determine whether such 

4 drug is generally recognized as 

5 safe and effective within the 

6 meaning of section 201(p)(1), 

7 which is filed by the Secretary 

8 under subparagraph (A)(ii). 

9 ‘‘(ii) EXCEPTION.—The Secretary is 

10 not required to complete review of a re11 quest for a change described in clause 

12 (i)(II) if the Secretary determines that 

13 there is an inadequate basis to find the 

14 drug is generally recognized as safe and ef15 fective within the meaning of section 

16 201(p)(1) under paragraph (1) and issues 

17 a final order announcing that determina18 tion. 

19 ‘‘(iii) WITHDRAWAL.—The requestor 

20 may withdraw a request under this para21 graph, according to the procedures set 

22 forth pursuant to subsection (d)(2)(B). 

23 Notwithstanding any other provision of 

24 this section, if such request is withdrawn, 
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1 the Secretary may cease proceedings under 

2 this subparagraph. 

3 ‘‘(C) EXCLUSIVITY.— 

4 ‘‘(i) IN GENERAL.—A final adminis5 trative order issued in response to a re6 quest under this section shall have the ef7 fect of authorizing solely the order re8 questor (or the licensees, assignees, or suc9 cessors in interest of such requestor with 

10 respect to the subject of such order), for a 

11 period of 18 months following the effective 

12 date of such final order, to market drugs— 

13 ‘‘(I) incorporating changes de14 scribed in clause (ii); 

15 ‘‘(II) beginning on the date the 

16 requestor (or any such licensees, as17 signees, or successors in interest) may 

18 lawfully market such drugs pursuant 

19 to the order; and 

20 ‘‘(III) subject to the limitations 

21 under clause (iv). 

22 ‘‘(ii) CHANGES DESCRIBED.—A 

23 change described in this clause is a change 

24 subject to an order specified in clause (i), 

25 which— 
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1 ‘‘(I) provides for a drug to con2 tain an active ingredient (including 

3 any ester or salt of the active ingre4 dient) not previously incorporated in a 

5 drug described in clause (iii); or 

6 ‘‘(II) provides for a change in the 

7 conditions of use of a drug, for which 

8 new human data studies conducted or 

9 sponsored by the requestor (or for 

10 which the requestor has an exclusive 

11 right of reference) were essential to 

12 the issuance of such order. 

13 ‘‘(iii) DRUGS DESCRIBED.—The drugs 

14 described in this clause are drugs— 

15 ‘‘(I) specified in subsection 

16 (a)(1), (a)(2), or (a)(3); 

17 ‘‘(II) subject to a final order 

18 issued under this section; 

19 ‘‘(III) subject to a final sun20 screen order (as defined in section 

21 586(2)(A)); or 

22 ‘‘(IV) described in subsection 

23 (m)(1), other than drugs subject to an 

24 active enforcement action under chap25 ter III of this Act. 
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1 ‘‘(iv) LIMITATIONS ON EXCLU2 SIVITY.— 

3 ‘‘(I) IN GENERAL.—Only one pe4 riod of exclusivity shall be granted, 

5 under each order described in clause 

6 (i), with respect to changes (to the 

7 drug subject to such order) which are 

8 either— 

9 ‘‘(aa) changes described in 

10 clause (ii)(I), relating to active 

11 ingredients; or 

12 ‘‘(bb) changes described in 

13 clause (ii)(II), relating to condi14 tions of use. 

15 ‘‘(II) NO EXCLUSIVITY AL16 LOWED.—No exclusivity shall apply to 

17 changes to a drug which are— 

18 ‘‘(aa) the subject of a Tier 2 

19 OTC monograph order request 

20 (as defined in section 744N); 

21 ‘‘(bb) safety-related changes, 

22 as defined by the Secretary, or 

23 any other changes the Secretary 

24 considers necessary to assure 

25 safe use; or 
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1 ‘‘(cc) changes related to 

2 methods of testing safety or effi3 cacy. 

4 ‘‘(v) NEW HUMAN DATA STUDIES DE5 FINED.—In this subparagraph, the term 

6 ‘new human data studies’ means clinical 

7 trials of safety or effectiveness (including 

8 actual use studies), pharmacokinetics stud9 ies, or bioavailability studies, the results of 

10 which— 

11 ‘‘(I) have not been relied on by 

12 the Secretary to support— 

13 ‘‘(aa) a proposed or final de14 termination that a drug described 

15 in subclauses (I), (II), or (III) of 

16 clause (iii) is generally recognized 

17 as safe and effective within the 

18 meaning of section 201(p)(1); or 

19 ‘‘(bb) approval of a drug 

20 that was approved under section 

21 505; and 

22 ‘‘(II) do not duplicate the results 

23 of another study that was relied on by 

24 the Secretary to support— 
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1 ‘‘(aa) a proposed or final de2 termination that a drug described 

3 in subclauses (I), (II), or (III) of 

4 clause (iii) is generally recognized 

5 as safe and effective within the 

6 meaning of section 201(p)(1); or 

7 ‘‘(bb) approval of a drug 

8 that was approved under section 

9 505. 

10 ‘‘(vi) EFFECTIVE DATE.—A final 

11 order subject to clause (i) shall take effect 

12 on the date when the order requestor (or 

13 the licensees, assignees, or successors in 

14 interest of such requestor with respect to 

15 such order) submits updated drug listing 

16 information under subsection (e) with re17 spect to the change which is permitted 

18 under such order. 

19 ‘‘(vii) GAO STUDY.—Not later than 4 

20 years after the date of enactment of the 

21 Over-the-Counter Monograph, Safety, In22 novation, and Reform Act of 2018, the 

23 Comptroller General of the United States 

24 shall submit a study to the Committee on 

25 Energy and Commerce of the House of 
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1 Representatives and the Committee on 

2 Health, Education, Labor, and Pensions of 

3 the Senate addressing the effectiveness and 

4 overall impact of exclusivity under this sec5 tion, including its impact on consumer ac6 cess. Such study shall include— 

7 ‘‘(I) the number of nonprescrip8 tion drug products that were granted 

9 exclusivity and the indication for 

10 which the nonprescription drug prod11 ucts were determined to be generally 

12 recognized as safe and effective; 

13 ‘‘(II) whether the exclusivity for 

14 such drug products was granted for— 

15 ‘‘(aa) a new active ingre16 dient (including any ester or salt 

17 of the active ingredient); or 

18 ‘‘(bb) changes in the condi19 tions of use of a drug, for which 

20 new human data studies con21 ducted or sponsored by the re22 questor were essential; 

23 ‘‘(III) whether, and to what ex24 tent, the exclusivity impacted the re-
35 

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1 questor’s or sponsor’s decision to de2 velop the drug product; 

3 ‘‘(IV) an analysis of the imple4 mentation of the exclusivity provision 

5 in this subparagraph, including— 

6 ‘‘(aa) the resources used by 

7 the Food and Drug Administra8 tion; 

9 ‘‘(bb) the impact of such 

10 provision on innovation, as well 

11 as research and development in 

12 the nonprescription drug market; 

13 ‘‘(cc) the impact of such 

14 provision on competition in the 

15 nonprescription drug market; 

16 ‘‘(dd) the impact of such 

17 provision on consumer access to 

18 nonprescription drug products; 

19 ‘‘(ee) the impact of such 

20 provision on the prices of non21 prescription drug products; and 

22 ‘‘(ff) whether the adminis23 trative orders initiated by reques24 tors under this section have been 

25 sufficient to encourage the devel-
36 

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1 opment of nonprescription drug 

2 products that would likely not be 

3 otherwise developed, or developed 

4 in as timely a manner; and 

5 ‘‘(V) whether the administrative 

6 orders initiated by requestors under 

7 this section have been sufficient incen8 tive to encourage innovation in the 

9 nonprescription drug market. 

10 ‘‘(6) INFORMATION REGARDING SAFE NON11 PRESCRIPTION MARKETING AND USE AS CONDITION

12 FOR FILING A GENERALLY RECOGNIZED AS SAFE

13 AND EFFECTIVE REQUEST.— 

14 ‘‘(A) IN GENERAL.—In response to a re15 quest under this section that a drug described 

16 in subparagraph (B) be generally recognized as 

17 safe and effective, the Secretary— 

18 ‘‘(i) may file such request, if the re19 quest includes information specified under 

20 subparagraph (C) with respect to safe non21 prescription marketing and use of such 

22 drug; or 

23 ‘‘(ii) if the request fails to include in24 formation specified under subparagraph 

25 (C), shall refuse to file such request and 
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1 require that nonprescription marketing of 

2 the drug be pursuant to a new drug appli3 cation as described in subparagraph (D). 

4 ‘‘(B) DRUG DESCRIBED.—A drug de5 scribed in this subparagraph is a nonprescrip6 tion drug which contains an active ingredient 

7 not previously incorporated in a drug— 

8 ‘‘(i) specified in subsection (a)(1), 

9 (a)(2), or (a)(3); 

10 ‘‘(ii) subject to a final order under 

11 this section; or 

12 ‘‘(iii) subject to a final sunscreen 

13 order (as defined in section 586(2)(A)). 

14 ‘‘(C) INFORMATION DEMONSTRATING

15 PRIMA FACIE SAFE NONPRESCRIPTION MAR16 KETING AND USE.—Information specified in 

17 this subparagraph, with respect to a request de18 scribed in subparagraph (A)(i), is— 

19 ‘‘(i) information sufficient for a prima 

20 facie demonstration that the drug subject 

21 to such request has a verifiable history of 

22 being marketed and safely used by con23 sumers in the United States as a non24 prescription drug under comparable condi25 tions of use; 
38 

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1 ‘‘(ii) if the drug has not been pre2 viously marketed in the United States as a 

3 nonprescription drug, information suffi4 cient for a prima facie demonstration that 

5 the drug was marketed and safely used 

6 under comparable conditions of marketing 

7 and use in a country listed in section 

8 802(b)(1)(A) or designated by the Sec9 retary in accordance with section 

10 802(b)(1)(B)— 

11 ‘‘(I) for such period of time as 

12 needed to provide reasonable assur13 ances concerning the safe nonprescrip14 tion use of the drug; and 

15 ‘‘(II) during such time was sub16 ject to sufficient monitoring by a reg17 ulatory body considered acceptable by 

18 the Secretary for such monitoring 

19 purposes, including for adverse events 

20 associated with nonprescription use of 

21 the drug; or 

22 ‘‘(iii) if the Secretary determines that 

23 information described in clauses (i) or (ii) 

24 is not needed to provide a prima facie dem25 onstration that the drug can be safely mar-
39 

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1 keted and used as a nonprescription drug, 

2 such other information the Secretary deter3 mines is sufficient for such purposes. 

4 ‘‘(D) MARKETING PURSUANT TO NEW

5 DRUG APPLICATION.—In the case of a request 

6 described in subparagraph (A)(ii), the drug 

7 subject to such request may be re-submitted for 

8 filing only if— 

9 ‘‘(i) the drug is marketed as a non10 prescription drug, under conditions of use 

11 comparable to the conditions specified in 

12 the request, for such period of time as the 

13 Secretary determines appropriate (not to 

14 exceed 5 consecutive years) pursuant to an 

15 application approved under section 505; 

16 and 

17 ‘‘(ii) during such time period, one mil18 lion retail packages of the drug, or an 

19 equivalent quantity as determined by the 

20 Secretary, were distributed for retail sale, 

21 as determined in such manner as the Sec22 retary finds appropriate. 

23 ‘‘(E) RULE OF APPLICATION.—Except in 

24 the case of a request involving a drug described 

25 in section 586(9), as in effect on January 1, 
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1 2017, if the Secretary refuses to file a request 

2 under this paragraph, the requestor may not 

3 file such request over protest under paragraph 

4 (5)(A)(iii). 

5 ‘‘(7) PACKAGING.—An administrative order 

6 issued under paragraph (2), (4)(A), or (5) may in7 clude requirements for the packaging of a drug to 

8 encourage use in accordance with labeling. Such re9 quirements may include unit dose packaging, re10 quirements for products intended for use by chil11 dren, requirements to reduce risk of harm from un12 supervised ingestion, and other appropriate require13 ments. This paragraph does not authorize the Food 

14 and Drug Administration to require standards or 

15 testing procedures as described in part 1700 of title 

16 16, Code of Federal Regulations. 

17 ‘‘(8) FINAL AND TENTATIVE FINAL MONO18 GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL

19 ADMINISTRATIVE ORDERS.— 

20 ‘‘(A) IN GENERAL.—A final monograph or 

21 tentative final monograph described in subpara22 graph (B) shall be deemed to be a final admin23 istrative order under this subsection and may 

24 be amended, revoked, or otherwise modified in 
41 

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1 accordance with the procedures of this sub2 section. 

3 ‘‘(B) MONOGRAPHS DESCRIBED.—For pur4 poses of subparagraph (A), a final monograph 

5 or tentative final monograph is described in this 

6 subparagraph if it— 

7 ‘‘(i) establishes conditions of use for a 

8 drug described in paragraph (1) or (2) of 

9 subsection (a); and 

10 ‘‘(ii) represents the most recently pro11 mulgated version of such conditions, in12 cluding as modified, in whole or in part, by 

13 any proposed or final rule. 

14 ‘‘(C) DEEMED ORDERS INCLUDE HARMO15 NIZING TECHNICAL AMENDMENTS.—The 

16 deemed establishment of a final administrative 

17 order under subparagraph (A) shall be con18 strued to include any technical amendments to 

19 such order as the Secretary determines nec20 essary to ensure that such order is appro21 priately harmonized, in terms of terminology or 

22 cross-references, with the applicable provisions 

23 of this Act (and regulations thereunder) and 

24 any other orders issued under this section. 

25 ‘‘(c) PROCEDURE FOR MINOR CHANGES.— 
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1 ‘‘(1) IN GENERAL.—Minor changes in the dos2 age form of a drug that is described in paragraph 

3 (1) or (2) of subsection (a) or the subject of an 

4 order issued under subsection (b) may be made by 

5 a requestor without the issuance of an order under 

6 subsection (b) if— 

7 ‘‘(A) the requestor maintains such infor8 mation as is necessary to demonstrate that the 

9 change— 

10 ‘‘(i) will not affect the safety or effec11 tiveness of the drug; and 

12 ‘‘(ii) will not materially affect the ex13 tent of absorption or other exposure to the 

14 active ingredient in comparison to a suit15 able reference product; and 

16 ‘‘(B) the change is in conformity with the 

17 requirements of an applicable administrative 

18 order issued by the Secretary under paragraph 

19 (3). 

20 ‘‘(2) ADDITIONAL INFORMATION.— 

21 ‘‘(A) ACCESS TO RECORDS.—A sponsor 

22 shall submit records requested by the Secretary 

23 relating to such a minor change under section 

24 704(a)(4), within 15 business days of receiving 
43 

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1 such a request, or such longer period as the 

2 Secretary may provide. 

3 ‘‘(B) INSUFFICIENT INFORMATION.—If the 

4 Secretary determines that the information con5 tained in such records is not sufficient to dem6 onstrate that the change does not affect the 

7 safety or effectiveness of the drug or materially 

8 affect the extent of absorption or other expo9 sure to the active ingredient, the Secretary— 

10 ‘‘(i) may so inform the sponsor of the 

11 drug in writing; and 

12 ‘‘(ii) provide the sponsor of the drug 

13 with a reasonable opportunity to provide 

14 additional information. 

15 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN16 FORMATION.—If the sponsor fails to provide 

17 such additional information within the pre18 scribed time, or if the Secretary determines that 

19 such additional information does not dem20 onstrate that the change does not affect the 

21 safety or effectiveness of the drug or materially 

22 affect the extent of absorption or other expo23 sure to the active ingredient, the drug as modi24 fied is a new drug within the meaning of sec-
44 

•HR 5333 EH

1 tion 201(p) and shall be deemed to be mis2 branded under section 502(ee). 

3 ‘‘(3) DETERMINING WHETHER A CHANGE WILL

4 AFFECT SAFETY OR EFFECTIVENESS.— 

5 ‘‘(A) IN GENERAL.—The Secretary shall 

6 issue one or more administrative orders speci7 fying requirements for determining whether a 

8 minor change made by a sponsor pursuant to 

9 this subsection will affect the safety or effective10 ness of a drug or materially affect the extent of 

11 absorption or other exposure to an active ingre12 dient in the drug in comparison to a suitable 

13 reference product, together with guidance for 

14 applying those orders to specific dosage forms. 

15 ‘‘(B) STANDARD PRACTICES.—The orders 

16 and guidance issued by the Secretary under 

17 subparagraph (A) shall take into account rel18 evant public standards and standard practices 

19 for evaluating the quality of drugs, and may 

20 take into account the special needs of popu21 lations, including children. 

22 ‘‘(d) CONFIDENTIALITY OF INFORMATION SUB23 MITTED TO THE SECRETARY.— 

24 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

25 any information, including reports of testing con-
45 

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1 ducted on the drug or drugs involved, that is sub2 mitted by a requestor in connection with proceedings 

3 on an order under this section (including any minor 

4 change under subsection (c)) and is a trade secret 

5 or confidential information subject to section 

6 552(b)(4) of title 5, United States Code, or section 

7 1905 of title 18, United States Code, shall not be 

8 disclosed to the public unless the requestor consents 

9 to that disclosure. 

10 ‘‘(2) PUBLIC AVAILABILITY.— 

11 ‘‘(A) IN GENERAL.—Except as provided in 

12 subparagraph (B), the Secretary shall— 

13 ‘‘(i) make any information submitted 

14 by a requestor in support of a request 

15 under subsection (b)(5)(A) available to the 

16 public not later than the date on which the 

17 proposed order is issued; and 

18 ‘‘(ii) make any information submitted 

19 by any other person with respect to an 

20 order requested (or initiated by the Sec21 retary) under subsection (b), available to 

22 the public upon such submission. 

23 ‘‘(B) LIMITATIONS ON PUBLIC AVAIL24 ABILITY.—Information described in subpara25 graph (A) shall not be made public if— 
46 

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1 ‘‘(i) the information pertains to phar2 maceutical quality information, unless such 

3 information is necessary to establish stand4 ards under which a drug is generally rec5 ognized as safe and effective within the 

6 meaning of section 201(p)(1); 

7 ‘‘(ii) the information is submitted in a 

8 requestor-initiated request, but the re9 questor withdraws such request, in accord10 ance with withdrawal procedures estab11 lished by the Secretary, before the Sec12 retary issues the proposed order; 

13 ‘‘(iii) the Secretary requests and ob14 tains the information under subsection (c) 

15 and such information is not submitted in 

16 relation to an order under subsection (b); 

17 or 

18 ‘‘(iv) the information is of the type 

19 contained in raw datasets. 

20 ‘‘(e) UPDATES TO DRUG LISTING INFORMATION.— 

21 A sponsor who makes a change to a drug subject to this 

22 section shall submit updated drug listing information for 

23 the drug in accordance with section 510(j) within 30 cal24 endar days of the date when the drug is first commercially 

25 marketed, except that a sponsor who was the order re-
47 

•HR 5333 EH

1 questor with respect to an order subject to subsection 

2 (b)(5)(C) (or a licensee, assignee, or successor in interest 

3 of such requestor) shall submit updated drug listing infor4 mation on or before the date when the drug is first com5 mercially marketed. 

6 ‘‘(f) APPROVALS UNDER SECTION 505.—The provi7 sions of this section shall not be construed to preclude a 

8 person from seeking or maintaining the approval of a drug 

9 under sections 505(b)(1), 505(b)(2), and 505(j). A deter10 mination under this section that a drug is not subject to 

11 section 503(b)(1), is generally recognized as safe and ef12 fective within the meaning of section 201(p)(1), and is not 

13 a new drug under section 201(p) shall constitute a finding 

14 that the drug is safe and effective that may be relied upon 

15 for purposes of an application under section 505(b)(2), so 

16 that the applicant shall be required to submit for purposes 

17 of such application only information needed to support any 

18 modification of the drug that is not covered by such deter19 mination under this section. 

20 ‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR21 DERS.—The Secretary shall establish, maintain, update 

22 (as determined necessary by the Secretary but no less fre23 quently than annually), and make publicly available, with 

24 respect to orders issued under this section— 
48 

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1 ‘‘(1) a repository of each final order and in2 terim final order in effect, including the complete 

3 text of the order; and 

4 ‘‘(2) a listing of all orders proposed and under 

5 development under subsection (b)(2), including— 

6 ‘‘(A) a brief description of each such order; 

7 and 

8 ‘‘(B) the Secretary’s expectations, if re9 sources permit, for issuance of proposed orders 

10 over a 3-year period. 

11 ‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE12 QUESTORS.—The Secretary shall establish procedures 

13 under which sponsors or requestors may meet with appro14 priate officials of the Food and Drug Administration to 

15 obtain advice on the studies and other information nec16 essary to support submissions under this section and other 

17 matters relevant to the regulation of nonprescription 

18 drugs and the development of new nonprescription drugs 

19 under this section. 

20 ‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE21 QUESTORS.—The Secretary shall establish procedures to 

22 facilitate efficient participation by multiple sponsors or re23 questors in proceedings under this section, including provi24 sion for joint meetings with multiple sponsors or reques-
49 

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1 tors or with organizations nominated by sponsors or re2 questors to represent their interests in a proceeding. 

3 ‘‘(j) ELECTRONIC FORMAT.—All submissions under 

4 this section shall be in electronic format. 

5 ‘‘(k) EFFECT ON EXISTING REGULATIONS GOV6 ERNING NONPRESCRIPTION DRUGS.— 

7 ‘‘(1) REGULATIONS OF GENERAL APPLICA8 BILITY TO NONPRESCRIPTION DRUGS.—Except as 

9 provided in this subsection, nothing in this section 

10 supersedes regulations establishing general require11 ments for nonprescription drugs, including regula12 tions of general applicability contained in parts 201, 

13 250, and 330 of title 21, Code of Federal Regula14 tions, or any successor regulations. The Secretary 

15 shall establish or modify such regulations by means 

16 of rulemaking in accordance with section 553 of title 

17 5, United States Code. 

18 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE19 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

20 ‘‘(A) The provisions of section 310.545 of 

21 title 21, Code of Federal Regulations, as in ef22 fect on the day before the date of the enact23 ment of this section, shall be deemed to be a 

24 final order under subsection (b). 
50 

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1 ‘‘(B) Regulations in effect on the day be2 fore the date of the enactment of this section, 

3 establishing requirements for specific non4 prescription drugs marketed pursuant to this 

5 section (including such requirements in parts 

6 201 and 250 of title 21, Code of Federal Regu7 lations), shall be deemed to be final orders 

8 under subsection (b), only as they apply to 

9 drugs— 

10 ‘‘(i) subject to paragraph (1), (2), (3), 

11 or (4) of subsection (a); or 

12 ‘‘(ii) otherwise subject to an order 

13 under this section. 

14 ‘‘(3) WITHDRAWAL OF REGULATIONS.—The 

15 Secretary shall withdraw regulations establishing 

16 final monographs and the procedures governing the 

17 over-the-counter drug review under part 330 and 

18 other relevant parts of title 21, Code of Federal 

19 Regulations (as in effect on the day before the date 

20 of the enactment of this section), or make technical 

21 changes to such regulations to ensure conformity 

22 with appropriate terminology and cross references. 

23 Notwithstanding subchapter II of chapter 5 of title 

24 5, United States Code, any such withdrawal or tech25 nical changes shall be made without public notice 
51 

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1 and comment and shall be effective upon publication 

2 through notice in the Federal Register (or upon such 

3 date as specified in such notice). 

4 ‘‘(l) GUIDANCE.—The Secretary shall issue guidance 

5 that specifies— 

6 ‘‘(1) the procedures and principles for formal 

7 meetings between the Secretary and sponsors or re8 questors for drugs subject to this section; 

9 ‘‘(2) the format and content of data submis10 sions to the Secretary under this section; 

11 ‘‘(3) the format of electronic submissions to the 

12 Secretary under this section; 

13 ‘‘(4) consolidated proceedings and the proce14 dures for such proceedings where appropriate; and 

15 ‘‘(5) for minor changes in drugs, recommenda16 tions on how to comply with the requirements in or17 ders issued under subsection (c)(3). 

18 ‘‘(m) RULE OF CONSTRUCTION.— 

19 ‘‘(1) IN GENERAL.—This section shall not af20 fect the treatment or status of a nonprescription 

21 drug— 

22 ‘‘(A) that is marketed without an applica23 tion approved under section 505 as of the date 

24 of the enactment of this section; 
52 

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1 ‘‘(B) that is not subject to an order issued 

2 under this section; and 

3 ‘‘(C) to which paragraphs (1), (2), (3), (4), 

4 or (5) of subsection (a) do not apply. 

5 ‘‘(2) TREATMENT OF PRODUCTS PREVIOUSLY

6 FOUND TO BE SUBJECT TO TIME AND EXTENT RE7 QUIREMENTS.— 

8 ‘‘(A) Notwithstanding subsection (a), a 

9 drug described in subparagraph (B) may only 

10 be lawfully marketed, without an application 

11 approved under section 505, pursuant to an 

12 order issued under this section. 

13 ‘‘(B) A drug described in this subpara14 graph is a drug which, prior to the date of the 

15 enactment of this section, the Secretary had de16 termined in a proposed or final rule to be ineli17 gible for review under the OTC drug review (as 

18 such phrase ‘OTC drug review’ was used in sec19 tion 330.14 of title 21, Code of Federal Regula20 tions, as in effect on the day before the date of 

21 the enactment of this section). 

22 ‘‘(3) PRESERVATION OF AUTHORITY.— 

23 ‘‘(A) Nothing in paragraph (1) shall be 

24 construed to preclude or limit the applicability 

25 of any other provision of this Act. 
53 

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1 ‘‘(B) Nothing in subsection (a) shall be 

2 construed to prohibit the Secretary from issuing 

3 an order under this section finding a drug to be 

4 not generally recognized as safe and effective 

5 within the meaning of section 201(p)(1), as the 

6 Secretary determines appropriate. 

7 ‘‘(n) INVESTIGATIONAL NEW DRUGS.—A drug is not 

8 subject to this section if an exemption for investigational 

9 use under section 505(i) is in effect for such drug. 

10 ‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION

11 ACT.—Chapter 35 of title 44, United States Code, shall 

12 not apply to collections of information made under this 

13 section. 

14 ‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT

15 RULEMAKING AND OTHER REQUIREMENTS.—The re16 quirements of subsection (b) shall apply with respect to 

17 orders issued under this section instead of the require18 ments of subchapter II of chapter 5 of title 5, United 

19 States Code. 

20 ‘‘(q) DEFINITIONS.—In this section: 

21 ‘‘(1) The term ‘nonprescription drug’ refers to 

22 a drug not subject to the requirements of section 

23 503(b)(1). 
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1 ‘‘(2) The term ‘sponsor’ refers to any person 

2 marketing, manufacturing, or processing a drug 

3 that— 

4 ‘‘(A) is listed pursuant to section 510(j); 

5 and 

6 ‘‘(B) is or will be subject to an administra7 tive order of the Food and Drug Administra8 tion. 

9 ‘‘(3) The term ‘requestor’ refers to any person 

10 or group of persons marketing, manufacturing, proc11 essing, or developing a drug.’’. 

12 SEC. 102. MISBRANDING. 

13 Section 502 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 352) is amended by adding at the end the 

15 following: 

16 ‘‘(ee) If it is a nonprescription drug that is subject 

17 to section 505G, is not the subject of an application ap18 proved under section 505, and does not comply with the 

19 requirements under section 505G. 

20 ‘‘(ff) If it is a drug and it was manufactured, pre21 pared, propagated, compounded, or processed in a facility 

22 for which fees have not been paid as required by section 

23 744O.’’. 
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1 SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE2 COUNTER DRUG REVIEW. 

3 (a) IN GENERAL.—Nothing in this Act (or the 

4 amendments made by this Act) shall apply to any non5 prescription drug which was excluded by the Food and 

6 Drug Administration from the Over-the-Counter Drug Re7 view in accordance with the statement set out at page 

8 9466 of volume 37 of the Federal Register, published on 

9 May 11, 1972. 

10 (b) RULE OF CONSTRUCTION.—Nothing in this sec11 tion shall be construed to preclude or limit the applica12 bility of any other provision of the Federal Food, Drug, 

13 and Cosmetic Act (21 U.S.C. 301 et seq.). 

14 SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT. 

15 (a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC16 TIVE INGREDIENTS.— 

17 (1) APPLICABILITY OF SECTION 505G FOR

18 PENDING SUBMISSIONS.— 

19 (A) IN GENERAL.—A sponsor of a non20 prescription sunscreen active ingredient or com21 bination of nonprescription sunscreen active in22 gredients that, as of the date of enactment of 

23 this Act, is subject to a proposed sunscreen 

24 order under section 586C of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 360fff–3) 

26 may elect, by means of giving written notifica-
56 

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1 tion to the Secretary of Health and Human 

2 Services within 180 calendar days of the enact3 ment of this Act, to transition into the review 

4 of such ingredient or combination of ingredients 

5 pursuant to the process set out in section 505G 

6 of the Federal Food, Drug, and Cosmetic Act, 

7 as added by section 101 of this Act. 

8 (B) ELECTION EXERCISED.—Upon receipt 

9 by the Secretary of Health and Human Services 

10 of a timely notification under subparagraph 

11 (A)— 

12 (i) the proposed sunscreen order in13 volved is deemed to be a request for an 

14 order under subsection (b) of section 505G 

15 of the Federal Food, Drug, and Cosmetic 

16 Act, as added by section 101 of this Act; 

17 and 

18 (ii) such order is deemed to have been 

19 accepted for filing under subsection 

20 (b)(6)(A)(i) of such section 505G. 

21 (C) ELECTION NOT EXERCISED.—A spon22 sor of a nonprescription sunscreen active ingre23 dient or combination of nonprescription sun24 screen active ingredients described in subpara25 graph (A) that does not elect for such ingre-
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1 dient or combination of ingredients to be re2 viewed under section 505G of the Federal Food, 

3 Drug, and Cosmetic Act, as added by section 

4 101 of this Act, shall continue to have such in5 gredient or combination of ingredients reviewed 

6 in accordance with section 586C of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 

8 360fff–3) and may not subsequently elect to 

9 transition into the review of such ingredient or 

10 combination of ingredients pursuant to the 

11 process set out in section 505G of such Act, as 

12 added by section 101 of this Act. 

13 (2) DEFINITIONS.—In this subsection, the 

14 terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac15 tive ingredient’’, and ‘‘proposed sunscreen order’’ 

16 have the meanings given to those terms in section 

17 586 of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 360fff). 

19 (b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 

20 (1) FINAL SUNSCREEN ORDERS.—Paragraph 

21 (3) of section 586C(e) of the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend23 ed to read as follows: 
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1 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC2 TION 505G.—A final sunscreen order shall be deemed 

3 to be a final order under section 505G.’’. 

4 (2) MEETINGS.—Paragraph (7) of section 

5 586C(b) of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360fff–3(b)) is amended— 

7 (A) by striking ‘‘A sponsor may request’’ 

8 and inserting the following: 

9 ‘‘(A) IN GENERAL.—A sponsor may re10 quest’’; and 

11 (B) by adding at the end the following: 

12 ‘‘(B) CONFIDENTIAL MEETINGS.—A spon13 sor may request one or more confidential meet14 ings with respect to a proposed sunscreen order, 

15 including a letter deemed to be a proposed sun16 screen order under paragraph (3), to discuss 

17 matters involving confidential commercial infor18 mation or trade secrets. The Secretary shall 

19 convene a confidential meeting with such spon20 sor in a reasonable time period. If a sponsor re21 quests more than one confidential meeting for 

22 the same proposed sunscreen order, the Sec23 retary may refuse to grant an additional con24 fidential meeting request if the Secretary deter25 mines that such additional confidential meeting 
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1 is not reasonably necessary for the sponsor to 

2 advance its proposed sunscreen order, or if the 

3 request for a confidential meeting fails to in4 clude sufficient information upon which to base 

5 a substantive discussion. The Secretary shall 

6 publish a post-meeting summary of each con7 fidential meeting under this subparagraph that 

8 does not disclose confidential commercial infor9 mation or trade secrets.’’. 

10 (3) SUNSET PROVISION.—Subchapter I of chap11 ter V of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 360fff et seq.) is amended by adding at 

13 the end the following: 

14 ‘‘SEC. 586H. SUNSET. 

15 ‘‘This subchapter shall cease to be effective at the end 

16 of fiscal year 2022.’’. 

17 (4) TREATMENT OF FINAL SUNSCREEN

18 ORDER.—The Federal Food, Drug, and Cosmetic 

19 Act is amended by striking section 586E of such Act 

20 (21 U.S.C. 360fff–5). 

21 (c) TREATMENT OF NON-SUNSCREEN TIME AND EX22 TENT APPLICATIONS.— 

23 (1) IN GENERAL.—Any application described in 

24 section 586F of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 360fff–6) that was submitted 
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1 to the Secretary of Health and Human Services pur2 suant to section 330.14 of title 21, Code of Federal 

3 Regulations, as such provisions were in effect imme4 diately prior to the date of enactment date of this 

5 Act, shall be extinguished as of such date of enact6 ment, subject to paragraph (2). 

7 (2) ORDER REQUEST.—Nothing in paragraph 

8 (1) precludes the submission of an order request 

9 under section 505G(b) of the Federal Food, Drug, 

10 and Cosmetic Act, as added by section 101 of this 

11 Act, with respect to a drug that was the subject of 

12 an application extinguished under paragraph (1). 

13 SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPRO14 PRIATE PEDIATRIC INDICATION FOR CER15 TAIN OTC COUGH AND COLD DRUGS. 

16 (a) IN GENERAL.—Subject to subsection (c), the Sec17 retary of Health and Human Services shall, beginning not 

18 later than 1 year after the date of enactment of this Act, 

19 annually submit to the Committee on Energy and Com20 merce of the House of Representatives and the Committee 

21 on Health, Education, Labor, and Pensions of the Senate 

22 a letter describing the progress of the Food and Drug Ad23 ministration— 
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1 (1) in evaluating the cough and cold monograph 

2 described in subsection (b) with respect to children 

3 under age 6; and 

4 (2) as appropriate, revising such cough and cold 

5 monograph to address such children through the 

6 order process under section 505G(b) of the Federal 

7 Food, Drug, and Cosmetic Act, as added by section 

8 101 of this Act. 

9 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

10 The cough and cold monograph described in this sub11 section consists of the conditions under which nonprescrip12 tion drugs containing antitussive, expectorant, nasal de13 congestant, or antihistamine active ingredients (or com14 binations thereof) are generally recognized as safe and ef15 fective, as specified in part 341 of title 21, Code of Federal 

16 Regulations (as in effect immediately prior to the date of 

17 enactment of this Act), and included in an order deemed 

18 to be established under section 505G(b) of the Federal 

19 Food, Drug, and Cosmetic Act, as added by section 101 

20 of this Act. 

21 (c) DURATION OF AUTHORITY.—The requirement 

22 under subsection (a) shall terminate as of the date of a 

23 letter submitted by the Secretary of Health and Human 

24 Services pursuant to such subsection in which the Sec25 retary indicates that the Food and Drug Administration 
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1 has completed its evaluation and revised, in a final order, 

2 as applicable, the cough and cold monograph as described 

3 in subsection (a)(2). 

4 TITLE II—USER FEES 

5 SEC. 201. SHORT TITLE; FINDING. 

6 (a) SHORT TITLE.—This title may be cited as the 

7 ‘‘Over-the-Counter Monograph User Fee Act of 2018’’. 

8 (b) FINDING.—The Congress finds that the fees au9 thorized by the amendments made in this title will be dedi10 cated to OTC monograph drug activities, as set forth in 

11 the goals identified for purposes of part 10 of subchapter 

12 C of chapter VII of the Federal Food, Drug, and Cosmetic 

13 Act, in the letters from the Secretary of Health and 

14 Human Services to the Chairman of the Committee on 

15 Health, Education, Labor, and Pensions of the Senate and 

16 the Chairman of the Committee on Energy and Commerce 

17 of the House of Representatives, as set forth in the Con18 gressional Record. 

19 SEC. 202. FEES RELATING TO OVER-THE-COUNTER DRUGS. 

20 Subchapter C of chapter VII of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is 

22 amended by inserting after part 9 the following: 
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1 ‘‘PART 10—FEES RELATING TO OVER-THE2 COUNTER DRUGS 

3 ‘‘SEC. 744N. DEFINITIONS. 

4 ‘‘In this part: 

5 ‘‘(1) The term ‘affiliate’ means a business enti6 ty that has a relationship with a second business en7 tity if, directly or indirectly— 

8 ‘‘(A) one business entity controls, or has 

9 the power to control, the other business entity; 

10 or 

11 ‘‘(B) a third party controls, or has power 

12 to control, both of the business entities. 

13 ‘‘(2) The term ‘contract manufacturing organi14 zation facility’ means an OTC monograph drug facil15 ity where neither the owner of such manufacturing 

16 facility nor any affiliate of such owner or facility 

17 sells the OTC monograph drug produced at such fa18 cility directly to wholesalers, retailers, or consumers 

19 in the United States. 

20 ‘‘(3) The term ‘costs of resources allocated for 

21 OTC monograph drug activities’ means the expenses 

22 in connection with OTC monograph drug activities 

23 for— 

24 ‘‘(A) officers and employees of the Food 

25 and Drug Administration, contractors of the 

26 Food and Drug Administration, advisory com-
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1 mittees, and costs related to such officers, em2 ployees, and committees and costs related to 

3 contracts with such contractors; 

4 ‘‘(B) management of information, and the 

5 acquisition, maintenance, and repair of com6 puter resources; 

7 ‘‘(C) leasing, maintenance, renovation, and 

8 repair of facilities and acquisition, maintenance, 

9 and repair of fixtures, furniture, scientific 

10 equipment, and other necessary materials and 

11 supplies; and 

12 ‘‘(D) collecting fees under section 744O 

13 and accounting for resources allocated for OTC 

14 monograph drug activities. 

15 ‘‘(4) The term ‘FDA establishment identifier’ is 

16 the unique number automatically generated by Food 

17 and Drug Administration’s Field Accomplishments 

18 and Compliance Tracking System (FACTS) (or any 

19 successor system). 

20 ‘‘(5) The term ‘OTC monograph drug’ means a 

21 nonprescription drug without an approved new drug 

22 application which is governed by the provisions of 

23 section 505G. 

24 ‘‘(6) The term ‘OTC monograph drug activities’ 

25 means activities of the Secretary associated with 
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1 OTC monograph drugs and inspection of facilities 

2 associated with such products, including the fol3 lowing activities: 

4 ‘‘(A) The activities necessary for review 

5 and evaluation of OTC monographs and OTC 

6 monograph order requests, including— 

7 ‘‘(i) orders proposing or finalizing ap8 plicable conditions of use for OTC mono9 graph drugs; 

10 ‘‘(ii) orders affecting status regarding 

11 general recognition of safety and effective12 ness of an OTC monograph ingredient or 

13 combination of ingredients under specified 

14 conditions of use; 

15 ‘‘(iii) all OTC monograph drug devel16 opment and review activities, including 

17 intraagency collaboration; 

18 ‘‘(iv) regulation and policy develop19 ment activities related to OTC monograph 

20 drugs; 

21 ‘‘(v) development of product standards 

22 for products subject to review and evalua23 tion; 

24 ‘‘(vi) meetings referred to in section 

25 505G(i); 
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1 ‘‘(vii) review of labeling prior to 

2 issuance of orders related to OTC mono3 graph drugs or conditions of use; and 

4 ‘‘(viii) regulatory science activities re5 lated to OTC monograph drugs. 

6 ‘‘(B) Inspections related to OTC mono7 graph drugs. 

8 ‘‘(C) Monitoring of clinical and other re9 search conducted in connection with OTC 

10 monograph drugs. 

11 ‘‘(D) Safety activities with respect to OTC 

12 monograph drugs, including— 

13 ‘‘(i) collecting, developing, and review14 ing safety information on OTC monograph 

15 drugs, including adverse event reports; 

16 ‘‘(ii) developing and using improved 

17 adverse event data-collection systems, in18 cluding information technology systems; 

19 and 

20 ‘‘(iii) developing and using improved 

21 analytical tools to assess potential safety 

22 risks, including access to external data23 bases. 

24 ‘‘(E) Other activities necessary for imple25 mentation of section 505G. 
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1 ‘‘(7) The term ‘OTC monograph order request’ 

2 means a request for an order submitted under sec3 tion 505G(b)(5). 

4 ‘‘(8) The term ‘Tier 1 OTC monograph order 

5 request’ means any OTC monograph order request 

6 not determined to be a Tier 2 OTC monograph 

7 order request. 

8 ‘‘(9)(A) The term ‘Tier 2 OTC monograph 

9 order request’ means, subject to subparagraph (B), 

10 an OTC monograph order request for— 

11 ‘‘(i) the reordering of existing information 

12 in the drug facts label of an OTC monograph 

13 drug; 

14 ‘‘(ii) the addition of information to the 

15 other information section of the drug facts label 

16 of an OTC monograph drug, as limited by sec17 tion 201.66(c)(7) of title 21, Code of Federal 

18 Regulations (or any successor regulations); 

19 ‘‘(iii) modification to the directions for use 

20 section of the drug facts label of an OTC mono21 graph drug, if such changes conform to changes 

22 made pursuant to section 505G(c)(3)(A); 

23 ‘‘(iv) the standardization of the concentra24 tion or dose of a specific finalized ingredient 

25 within a particular finalized monograph; 
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1 ‘‘(v) a change to ingredient nomenclature 

2 to align with nomenclature of a standards-set3 ting organization; or 

4 ‘‘(vi) addition of an interchangeable term 

5 in accordance with section 330.1 of title 21, 

6 Code of Federal Regulations (or any successor 

7 regulations). 

8 ‘‘(B) The Secretary may, based on program im9 plementation experience or other factors found ap10 propriate by the Secretary, characterize any OTC 

11 monograph order request as a Tier 2 OTC mono12 graph order request (including recharacterizing a re13 quest from Tier 1 to Tier 2) and publish such deter14 mination in a proposed order issued pursuant to sec15 tion 505G. 

16 ‘‘(10)(A) The term ‘OTC monograph drug facil17 ity’ means a foreign or domestic business or other 

18 entity that— 

19 ‘‘(i) is— 

20 ‘‘(I) under one management, either di21 rect or indirect; and 

22 ‘‘(II) at one geographic location or ad23 dress engaged in manufacturing or proc24 essing the finished dosage form of an OTC 

25 monograph drug; 
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1 ‘‘(ii) includes a finished dosage form man2 ufacturer facility in a contractual relationship 

3 with the sponsor of one or more OTC mono4 graph drugs to manufacture or process such 

5 drugs; and 

6 ‘‘(iii) does not include a business or other 

7 entity whose only manufacturing or processing 

8 activities are one or more of the following: pro9 duction of clinical research supplies, or testing. 

10 ‘‘(B) For purposes of subparagraph (A)(i)(II), 

11 separate buildings or locations within close proximity 

12 are considered to be at one geographic location or 

13 address if the activities conducted in such buildings 

14 or locations are— 

15 ‘‘(i) closely related to the same business 

16 enterprise; 

17 ‘‘(ii) under the supervision of the same 

18 local management; and 

19 ‘‘(iii) under a single FDA establishment 

20 identifier and capable of being inspected by the 

21 Food and Drug Administration during a single 

22 inspection. 

23 ‘‘(C) If a business or other entity would meet 

24 criteria specified in subparagraph (A), but for being 

25 under multiple management, the business or other 
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1 entity is deemed to constitute multiple facilities, one 

2 per management entity, for purposes of this para3 graph. 

4 ‘‘(11) The term ‘OTC monograph drug meet5 ing’ means any meeting regarding the content of a 

6 proposed OTC monograph order request. 

7 ‘‘(12) The term ‘person’ includes an affiliate of 

8 a person. 

9 ‘‘(13) The terms ‘requestor’ and ‘sponsor’ have 

10 the meanings given such terms in section 505G. 

11 ‘‘SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONO12 GRAPH FEES. 

13 ‘‘(a) TYPES OF FEES.—Beginning with fiscal year 

14 2019, the Secretary shall assess and collect fees in accord15 ance with this section as follows: 

16 ‘‘(1) FACILITY FEE.— 

17 ‘‘(A) IN GENERAL.—Each person that 

18 owns a facility identified as an OTC monograph 

19 drug facility on December 31 of the fiscal year 

20 or at any time during the preceding 12-month 

21 period shall be assessed an annual fee for each 

22 such facility as determined under subsection 

23 (c). 

24 ‘‘(B) EXCEPTIONS.— 
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1 ‘‘(i) A fee shall not be assessed under 

2 subparagraph (A) if the identified OTC 

3 monograph drug facility has ceased all ac4 tivities related to OTC monograph drugs 

5 prior to the date specified in subparagraph 

6 (D)(ii) and has updated its registration to 

7 reflect such change under the requirements 

8 for drug establishment registration set 

9 forth in section 510. 

10 ‘‘(ii) The amount of the fee for a con11 tract manufacturing organization facility 

shall be equal to 2 12 ⁄3 the amount of the fee 

13 for an OTC monograph drug facility that 

14 is not a contract manufacturing organiza15 tion facility. 

16 ‘‘(C) AMOUNT.—The amount of fees estab17 lished under subparagraph (A) shall be estab18 lished under subsection (c). 

19 ‘‘(D) DUE DATE.— 

20 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

21 fiscal year 2019, the facility fees required 

22 under subparagraph (A) shall be due 45 

23 calendar days after publication of the Fed24 eral Register notice provided for under 

25 subsection (c)(4)(A). 
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1 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

2 For each fiscal year after fiscal year 2019, 

3 the facility fees required under subpara4 graph (A) shall be due on the later of— 

5 ‘‘(I) the first business day of 

6 June of such year; or 

7 ‘‘(II) the first business day after 

8 the enactment of an appropriations 

9 Act providing for the collection and 

10 obligation of fees under this section 

11 for such year. 

12 ‘‘(2) OTC MONOGRAPH ORDER REQUEST

13 FEE.— 

14 ‘‘(A) IN GENERAL.—Each person that sub15 mits an OTC monograph order request shall be 

16 subject to a fee for an OTC monograph order 

17 request. The amount of such fee shall be— 

18 ‘‘(i) for a Tier 1 OTC monograph 

19 order request, $500,000, adjusted for in20 flation for the fiscal year (as determined 

21 under subsection (c)(1)(B)); and 

22 ‘‘(ii) for a Tier 2 OTC monograph 

23 order request, $100,000 adjusted for infla24 tion for the fiscal year (as determined 

25 under subsection (c)(1)(B)). 
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1 ‘‘(B) DUE DATE.—The OTC monograph 

2 order request fees required under subparagraph 

3 (A) shall be due on the date of submission of 

4 the OTC monograph order request. 

5 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

6 CHANGES.—A person who is named as the re7 questor in an OTC monograph order shall not 

8 be subject to a fee under subparagraph (A) if 

9 the Secretary finds that the OTC monograph 

10 order request seeks to change the drug facts la11 beling of an OTC monograph drug in a way 

12 that would add to or strengthen— 

13 ‘‘(i) a contraindication, warning, or 

14 precaution; 

15 ‘‘(ii) a statement about risk associated 

16 with misuse or abuse; or 

17 ‘‘(iii) an instruction about dosage and 

18 administration that is intended to increase 

19 the safe use of the OTC monograph drug. 

20 ‘‘(D) REFUND OF FEE IF ORDER REQUEST

21 IS RECATEGORIZED AS A TIER 2 OTC MONO22 GRAPH ORDER REQUEST.—If the Secretary de23 termines that an OTC monograph request ini24 tially characterized as Tier 1 shall be re-charac25 terized as a Tier 2 OTC monograph order re-
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1 quest, and the requestor has paid a Tier 1 fee 

2 in accordance with subparagraph (A)(i), the 

3 Secretary shall refund the requestor the dif4 ference between the Tier 1 and Tier 2 fees de5 termined under subparagraphs (A)(i) and 

6 (A)(ii), respectively. 

7 ‘‘(E) REFUND OF FEE IF ORDER REQUEST

8 REFUSED FOR FILING OR WITHDRAWN BEFORE

9 FILING.—The Secretary shall refund 75 percent 

10 of the fee paid under subparagraph (B) for any 

11 order request which is refused for filing or was 

12 withdrawn before being accepted or refused for 

13 filing. 

14 ‘‘(F) FEES FOR ORDER REQUESTS PRE15 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

16 BEFORE FILING.—An OTC monograph order 

17 request that was submitted but was refused for 

18 filing, or was withdrawn before being accepted 

19 or refused for filing, shall be subject to the full 

20 fee under subparagraph (A) upon being resub21 mitted or filed over protest. 

22 ‘‘(G) REFUND OF FEE IF ORDER REQUEST

23 WITHDRAWN.—If an order request is withdrawn 

24 after the order request was filed, the Secretary 

25 may refund the fee or a portion of the fee if no 
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1 substantial work was performed on the order 

2 request after the application was filed. The Sec3 retary shall have the sole discretion to refund a 

4 fee or a portion of the fee under this subpara5 graph. A determination by the Secretary con6 cerning a refund under this subparagraph shall 

7 not be reviewable. 

8 ‘‘(3) REFUNDS.— 

9 ‘‘(A) IN GENERAL.—Other than refunds 

10 provided in subparagraphs (D) through (G) of 

11 paragraph (2), the Secretary shall not refund 

12 any fee paid under paragraph (1) except as pro13 vided in subparagraph (B). 

14 ‘‘(B) DISPUTES CONCERNING FEES.—To 

15 qualify for the return of a fee claimed to have 

16 been paid in error under paragraph (1) or (2), 

17 a person shall submit to the Secretary a written 

18 request justifying such return within 180 cal19 endar days after such fee was paid. 

20 ‘‘(4) NOTICE.—Within the timeframe specified 

21 in subsection (c), the Secretary shall publish in the 

22 Federal Register the amount of the fees under para23 graph (1) for such fiscal year. 

24 ‘‘(b) FEE REVENUE AMOUNTS.— 
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1 ‘‘(1) FISCAL YEAR 2019.—For fiscal year 2019, 

2 fees under subsection (a)(1) shall be established to 

3 generate a total facility fee revenue amount equal to 

4 the sum of— 

5 ‘‘(A) the annual base revenue for fiscal 

6 year 2019 (as determined under paragraph (3); 

7 ‘‘(B) the dollar amount equal to the oper8 ating reserve adjustment for the fiscal year, if 

9 applicable (as determined under subsection 

10 (c)(2)); and 

11 ‘‘(C) additional direct cost adjustments (as 

12 determined under subsection (c)(3)). 

13 ‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 

14 the fiscal years 2020 through 2023, fees under sub15 section (a)(1) shall be established to generate a total 

16 facility fee revenue amount equal to the sum of— 

17 ‘‘(A) the annual base revenue for the fiscal 

18 year (as determined under paragraph (3)); 

19 ‘‘(B) the dollar amount equal to the infla20 tion adjustment for the fiscal year (as deter21 mined under subsection (c)(1)); 

22 ‘‘(C) the dollar amount equal to the oper23 ating reserve adjustment for the fiscal year, if 

24 applicable (as determined under subsection 

25 (c)(2)); 
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1 ‘‘(D) additional direct cost adjustments (as 

2 determined under subsection (c)(3)); and 

3 ‘‘(E) additional dollar amounts for each 

4 fiscal year as follows: 

5 ‘‘(i) $7 million for fiscal year 2020. 

6 ‘‘(ii) $6 million for fiscal year 2021. 

7 ‘‘(iii) $7 million for fiscal year 2022. 

8 ‘‘(iv) $3 million for fiscal year 2023. 

9 ‘‘(3) ANNUAL BASE REVENUE.—For purposes 

10 of paragraphs (1)(A) and (2)(A), the dollar amount 

11 of the annual base revenue for a fiscal year shall 

12 be— 

13 ‘‘(A) for fiscal year 2019, $8 million; and 

14 ‘‘(B) for fiscal years 2020 through 2023, 

15 the dollar amount of the total revenue amount 

16 established under this subsection for the pre17 vious fiscal year, not including any adjustments 

18 made under subsection (c)(2) or (c)(3). 

19 ‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 

20 ‘‘(1) INFLATION ADJUSTMENT.— 

21 ‘‘(A) IN GENERAL.—For purposes of sub22 section (b)(2)(B), the dollar amount of the in23 flation adjustment to the annual base revenue 

24 for fiscal year 2020 and each subsequent fiscal 

25 year shall be equal to the product of— 
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1 ‘‘(i) such annual base revenue for the 

2 fiscal year under subsection (b)(2); and 

3 ‘‘(ii) the inflation adjustment percent4 age under subparagraph (C). 

5 ‘‘(B) OTC MONOGRAPH ORDER REQUEST

6 FEES.—For purposes of subsection (a)(2), the 

7 dollar amount of the inflation adjustment to the 

8 fee for OTC monograph order requests for fis9 cal year 2020 and each subsequent fiscal year 

10 shall be equal to the product of— 

11 ‘‘(i) the applicable fee under sub12 section (a)(2) for the preceding fiscal year; 

13 and 

14 ‘‘(ii) the inflation adjustment percent15 age under subparagraph (C). 

16 ‘‘(C) INFLATION ADJUSTMENT PERCENT17 AGE.—The inflation adjustment percentage 

18 under this subparagraph for a fiscal year is 

19 equal to— 

20 ‘‘(i) for each of fiscal years 2020 and 

21 2021, the average annual percent change 

22 that occurred in the Consumer Price Index 

23 for urban consumers (Washington-Balti24 more, DC–MD–VA–WV; Not Seasonally 

25 Adjusted; All items; Annual Index) for the 
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1 first 3 years of the preceding 4 years of 

2 available data; and 

3 ‘‘(ii) for each of fiscal years 2022 and 

4 2023, the sum of— 

5 ‘‘(I) the average annual percent 

6 change in the cost, per full-time equiv7 alent position of the Food and Drug 

8 Administration, of all personnel com9 pensation and benefits paid with re10 spect to such positions for the first 3 

11 years of the preceding 4 fiscal years, 

12 multiplied by the proportion of per13 sonnel compensation and benefits 

14 costs to total costs of OTC mono15 graph drug activities for the first 3 

16 years of the preceding 4 fiscal years; 

17 and 

18 ‘‘(II) the average annual percent 

19 change that occurred in the Consumer 

20 Price Index for urban consumers 

21 (Washington-Baltimore, DC–MD–VA– 

22 WV; Not Seasonally Adjusted; All 

23 items; Annual Index) for the first 3 

24 years of the preceding 4 years of 

25 available data multiplied by the pro-
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1 portion of all costs other than per2 sonnel compensation and benefits 

3 costs to total costs of OTC mono4 graph drug activities for the first 3 

5 years of the preceding 4 fiscal years. 

6 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

7 ‘‘(A) IN GENERAL.—For fiscal year 2019 

8 and subsequent fiscal years, for purposes of 

9 subsections (b)(1)(B) and (b)(2)(C), the Sec10 retary may, in addition to adjustments under 

11 paragraph (1), further increase the fee revenue 

12 and fees if such an adjustment is necessary to 

13 provide operating reserves of carryover user 

14 fees for OTC monograph drug activities for not 

15 more than the number of weeks specified in 

16 subparagraph (B). 

17 ‘‘(B) NUMBER OF WEEKS.—The number of 

18 weeks specified in this subparagraph is— 

19 ‘‘(i) 3 weeks for fiscal year 2019; 

20 ‘‘(ii) 7 weeks for fiscal year 2020; 

21 ‘‘(iii) 10 weeks for fiscal year 2021; 

22 ‘‘(iv) 10 weeks for fiscal year 2022; 

23 and 

24 ‘‘(v) 10 weeks for fiscal year 2023. 
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1 ‘‘(C) DECREASE.—If the Secretary has 

2 carryover balances for such process in excess of 

3 10 weeks of the operating reserves referred to 

4 in subparagraph (A), the Secretary shall de5 crease the fee revenue and fees referred to in 

6 such subparagraph to provide for not more than 

7 10 weeks of such operating reserves. 

8 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

9 an adjustment under this paragraph is made, 

10 the rationale for the amount of the increase or 

11 decrease (as applicable) in fee revenue and fees 

12 shall be contained in the annual Federal Reg13 ister notice under paragraph (4) establishing 

14 fee revenue and fees for the fiscal year involved. 

15 ‘‘(3) ADDITIONAL DIRECT COST ADJUST16 MENT.—The Secretary shall, in addition to adjust17 ments under paragraphs (1) and (2), further in18 crease the fee revenue and fees for purposes of sub19 section (b)(2)(D) by an amount equal to— 

20 ‘‘(A) $14 million for fiscal year 2019; 

21 ‘‘(B) $7 million for fiscal year 2020; 

22 ‘‘(C) $4 million for fiscal year 2021; 

23 ‘‘(D) $3 million for fiscal year 2022; and 

24 ‘‘(E) $3 million for fiscal year 2023. 

25 ‘‘(4) ANNUAL FEE SETTING.— 
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1 ‘‘(A) FISCAL YEAR 2019.—The Secretary 

2 shall, not later than January 31, 2019— 

3 ‘‘(i) establish OTC monograph drug 

4 facility fees for fiscal year 2019 under sub5 section (a), based on the revenue amount 

6 for such year under subsection (b) and the 

7 adjustments provided under this sub8 section; and 

9 ‘‘(ii) publish fee revenue, facility fees, 

10 and OTC monograph order requests in the 

11 Federal Register. 

12 ‘‘(B) SUBSEQUENT FISCAL YEARS.—The 

13 Secretary shall, not later than January 31 of 

14 each fiscal year that begins after September 30, 

15 2019, establish for each such fiscal year, based 

16 on the revenue amounts under subsection (b) 

17 and the adjustments provided under this sub18 section— 

19 ‘‘(i) OTC monograph drug facility fees 

20 under subsection (a)(1); 

21 ‘‘(ii) OTC monograph order request 

22 fees under subsection (a)(2); and 

23 ‘‘(iii) publish such fee revenue 

24 amounts, facility fees, and OTC mono-
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1 graph order request fees in the Federal 

2 Register. 

3 ‘‘(d) IDENTIFICATION OF FACILITIES.—Each person 

4 that owns an OTC monograph drug facility shall submit 

5 to the Secretary the information required under this sub6 section each year. Such information shall, for each fiscal 

7 year— 

8 ‘‘(1) be submitted as part of the requirements 

9 for drug establishment registration set forth in sec10 tion 510; and 

11 ‘‘(2) include for each such facility, at a min12 imum, identification of the facility’s business oper13 ation as that of an OTC monograph drug facility. 

14 ‘‘(e) EFFECT OF FAILURE TO PAY FEES.— 

15 ‘‘(1) OTC MONOGRAPH DRUG FACILITY FEE.— 

16 ‘‘(A) IN GENERAL.—Failure to pay the fee 

17 under subsection (a)(1) within 20 calendar days 

18 of the due date as specified in subparagraph 

19 (D) of such subsection shall result in the fol20 lowing: 

21 ‘‘(i) The Secretary shall place the fa22 cility on a publicly available arrears list. 

23 ‘‘(ii) All OTC monograph drugs man24 ufactured in such a facility or containing 

25 an ingredient manufactured in such a facil-
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1 ity shall be deemed misbranded under sec2 tion 502(a). 

3 ‘‘(B) APPLICATION OF PENALTIES.—The 

4 penalties under this paragraph shall apply until 

5 the fee established by subsection (a)(1) is paid. 

6 ‘‘(2) ORDER REQUESTS.—An OTC monograph 

7 order request submitted by a person subject to fees 

8 under subsection (a) shall be considered incomplete 

9 and shall not be accepted for filing by the Secretary 

10 until all fees owed by such person under this section 

11 have been paid. 

12 ‘‘(3) MEETINGS.—A person subject to fees 

13 under this section shall be considered ineligible for 

14 OTC monograph drug meetings until all such fees 

15 owed by such person have been paid. 

16 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

17 ‘‘(1) IN GENERAL.—Fees authorized under sub18 section (a) shall be collected and available for obliga19 tion only to the extent and in the amount provided 

20 in advance in appropriations Acts. Such fees are au21 thorized to remain available until expended. Such 

22 sums as may be necessary may be transferred from 

23 the Food and Drug Administration salaries and ex24 penses appropriation account without fiscal year lim25 itation to such appropriation account for salaries 
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1 and expenses with such fiscal year limitation. The 

2 sums transferred shall be available solely for OTC 

3 monograph drug activities. 

4 ‘‘(2) COLLECTIONS AND APPROPRIATION

5 ACTS.— 

6 ‘‘(A) IN GENERAL.—Subject to subpara7 graph (C), the fees authorized by this section 

8 shall be collected and available in each fiscal 

9 year in an amount not to exceed the amount 

10 specified in appropriation Acts, or otherwise 

11 made available for obligation, for such fiscal 

12 year. 

13 ‘‘(B) USE OF FEES AND LIMITATION.— 

14 The fees authorized by this section shall be 

15 available to defray increases in the costs of the 

16 resources allocated for OTC monograph drug 

17 activities (including increases in such costs for 

18 an additional number of full-time equivalent po19 sitions in the Department of Health and 

20 Human Services to be engaged in such activi21 ties), only if the Secretary allocates for such 

22 purpose an amount for such fiscal year (exclud23 ing amounts from fees collected under this sec24 tion) no less than $12 million, multiplied by the 
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1 adjustment factor applicable to the fiscal year 

2 involved under subsection (c)(1). 

3 ‘‘(C) COMPLIANCE.—The Secretary shall 

4 be considered to have met the requirements of 

5 subparagraph (B) in any fiscal year if the costs 

6 funded by appropriations and allocated for OTC 

7 monograph drug activities are not more than 15 

8 percent below the level specified in such sub9 paragraph. 

10 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

11 SUBSEQUENT YEARS.—Payment of fees author12 ized under this section for a fiscal year (after 

13 fiscal year 2019), prior to the due date for such 

14 fees, may be accepted by the Secretary in ac15 cordance with authority provided in advance in 

16 a prior year appropriations Act. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 For each of the fiscal years 2019 through 2023, 

19 there is authorized to be appropriated for fees under 

20 this section an amount equal to the total amount of 

21 fees assessed for such fiscal year under this section. 

22 ‘‘(g) COLLECTION OF UNPAID FEES.—In any case 

23 where the Secretary does not receive payment of a fee as24 sessed under subsection (a) within 30 calendar days after 

25 it is due, such fee shall be treated as a claim of the United 
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1 States Government subject to subchapter II of chapter 37 

2 of title 31, United States Code. 

3 ‘‘(h) CONSTRUCTION.—This section may not be con4 strued to require that the number of full-time equivalent 

5 positions in the Department of Health and Human Serv6 ices, for officers, employers, and advisory committees not 

7 engaged in OTC monograph drug activities, be reduced 

8 to offset the number of officers, employees, and advisory 

9 committees so engaged. 

10 ‘‘SEC. 744P. REAUTHORIZATION; REPORTING REQUIRE11 MENTS. 

12 ‘‘(a) PERFORMANCE REPORT.—Beginning with fiscal 

13 year 2019, and not later than 120 calendar days after the 

14 end of each fiscal year thereafter for which fees are col15 lected under this part, the Secretary shall prepare and 

16 submit to the Committee on Energy and Commerce of the 

17 House of Representatives and the Committee on Health, 

18 Education, Labor, and Pensions of the Senate a report 

19 concerning the progress of the Food and Drug Adminis20 tration in achieving the goals identified in the letters de21 scribed in section 201(b) of the Over-the-Counter Mono22 graph Safety, Innovation, and Reform Act of 2018 during 

23 such fiscal year and the future plans of the Food and 

24 Drug Administration for meeting such goals. 
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1 ‘‘(b) FISCAL REPORT.—Not later than 120 calendar 

2 days after the end of fiscal year 2019 and each subsequent 

3 fiscal year for which fees are collected under this part, 

4 the Secretary shall prepare and submit to the Committee 

5 on Energy and Commerce of the House of Representatives 

6 and the Committee on Health, Education, Labor, and 

7 Pensions of the Senate a report on the implementation 

8 of the authority for such fees during such fiscal year and 

9 the use, by the Food and Drug Administration, of the fees 

10 collected for such fiscal year. 

11 ‘‘(c) PUBLIC AVAILABILITY.—The Secretary shall 

12 make the reports required under subsections (a) and (b) 

13 available to the public on the Internet website of the Food 

14 and Drug Administration. 

15 ‘‘(d) REAUTHORIZATION.— 

16 ‘‘(1) CONSULTATION.—In developing rec17 ommendations to present to the Congress with re18 spect to the goals described in subsection (a), and 

19 plans for meeting the goals, for OTC monograph 

20 drug activities for the first 5 fiscal years after fiscal 

21 year 2023, and for the reauthorization of this part 

22 for such fiscal years, the Secretary shall consult 

23 with— 

24 ‘‘(A) the Committee on Energy and Com25 merce of the House of Representatives; 
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1 ‘‘(B) the Committee on Health, Education, 

2 Labor, and Pensions of the Senate; 

3 ‘‘(C) scientific and academic experts; 

4 ‘‘(D) health care professionals; 

5 ‘‘(E) representatives of patient and con6 sumer advocacy groups; and 

7 ‘‘(F) the regulated industry. 

8 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA9 TIONS.—After negotiations with the regulated indus10 try, the Secretary shall— 

11 ‘‘(A) present the recommendations devel12 oped under paragraph (1) to the congressional 

13 committees specified in such paragraph; 

14 ‘‘(B) publish such recommendations in the 

15 Federal Register; 

16 ‘‘(C) provide for a period of 30 calendar 

17 days for the public to provide written comments 

18 on such recommendations; 

19 ‘‘(D) hold a meeting at which the public 

20 may present its views on such recommenda21 tions; and 

22 ‘‘(E) after consideration of such public 

23 views and comments, revise such recommenda24 tions as necessary. 
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1 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

2 Not later than January 15, 2023, the Secretary 

3 shall transmit to the Congress the revised rec4 ommendations under paragraph (2), a summary of 

5 the views and comments received under such para6 graph, and any changes made to the recommenda7 tions in response to such views and comments.’’. 

Passed the House of Representatives July 16, 2018. 

Attest: 

Clerk. 

115TH CONGRESS 

2D SESSION H. R. 5333 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

tion, and for other purposes. marketed without an approved new drug applicaspect to certain nonprescription drugs that are Act to clarify the regulatory framework with re-