IB 

Union Calendar No. 640 

115TH CONGRESS 

2D SESSION H. R. 5333 

[Report No. 115–827] 

To amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory 

framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 19, 2018 

Mr. LATTA (for himself, Mr. BURGESS, Mr. GENE GREEN of Texas, Ms. 

DEGETTE, Mr. GUTHRIE, and Mrs. DINGELL) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

JULY 16, 2018 

Additional sponsors: Ms. MATSUI, Mr. FLEISCHMANN, and Mr. SCHRADER

JULY 16, 2018 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on March 19, 2018] 


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A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

clarify the regulatory framework with respect to certain 

nonprescription drugs that are marketed without an approved new drug application, and for other purposes. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Over-the-Counter Mono5 graph Safety, Innovation, and Reform Act of 2018’’. 

6 TITLE I—OTC DRUG REVIEW 

7 SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 

8 DRUGS THAT ARE MARKETED WITHOUT AN 

9 APPROVED NEW DRUG APPLICATION. 

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

11 Drug, and Cosmetic Act is amended by inserting after sec12 tion 505F of such Act (21 U.S.C. 355g) the following: 

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

14 DRUGS THAT ARE MARKETED WITHOUT AN 

15 APPROVED NEW DRUG APPLICATION. 

16 ‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITHOUT

17 AN APPROVED APPLICATION.—Nonprescription drugs mar18 keted without an approved new drug application under sec19 tion 505, as of the date of the enactment of the Over-the20 Counter Monograph Safety, Innovation, and Reform Act of 

21 2018, shall be treated in accordance with this subsection. 

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

23 CATEGORY I DRUGS SUBJECT TO A TENTATIVE FINAL

24 MONOGRAPH.—A drug is deemed to be generally rec25 ognized as safe and effective within the meaning of 


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1 section 201(p)(1), not a new drug under section 

2 201(p), and not subject to section 503(b)(1), 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), and 

11 (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 of 

18 this section, has been used to a material ex19 tent 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 such 

5 tentative final monograph, any applicable 

6 subsequent determination by the Secretary, 

7 the general requirements for nonprescription 

8 drugs, and requirements under subsections 

9 (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 of 

16 this section, has been used to a material ex17 tent and for a material time within the 

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

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

20 respect to sunscreen drugs subject to this section, the 

21 applicable requirements shall be the requirements 

22 specified in part 352 of title 21, Code of Federal Reg23 ulations, as published on May 21, 1999, beginning on 

24 page 27687 of volume 64 of the Federal Register, ex25 cept that the applicable requirements governing effecVerDate Sep 11 2014 22:29 Jul 16, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H5333.RH H5333

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1 tiveness and labeling shall be those specified in section 

2 201.327 of title 21, Code of Federal Regulations, sub3 ject to the requirements of subsections (b), (c), and 

4 (k). 

5 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN6 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS SUB7 JECT TO PROPOSED MONOGRAPH OR ADVANCE NOTICE

8 OF PROPOSED RULEMAKING.—A drug that is not de9 scribed in paragraphs (1), (2), or (4) is not required 

10 to be the subject of an application approved under 

11 section 505, and is not subject to section 503(b)(1), 

12 if— 

13 ‘‘(A) the drug is— 

14 ‘‘(i) classified in category III for safety 

15 or effectiveness in the preamble of a pro16 posed 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, Code 

20 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 for 

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

14 ‘‘(iii) in a dosage form that, imme15 diately prior to the date of the enactment of 

16 this section, was not required to have satis17 fied the requirements of section 330.14 of 

18 title 21, Code of Federal Regulations (as in 

19 effect at that time), in order for such drug 

20 to be lawfully marketed without an applica21 tion approved under section 505; or 

22 ‘‘(B) the drug is— 

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

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1 making that is the most recently applicable 

2 proposal or determination for such drug 

3 issued under part 330 of title 21, Code of 

4 Federal Regulations; 

5 ‘‘(ii) in conformity with the require6 ments for nonprescription use of such pro7 posed monograph or advance notice of pro8 posed rulemaking, any applicable subse9 quent determination by the Secretary, the 

10 general requirements for nonprescription 

11 drugs, and requirements under subsections 

12 (b) or (k); and 

13 ‘‘(iii) in a dosage form that, imme14 diately prior to the date of the enactment of 

15 this section, has been used to a material ex16 tent and for a material time within the 

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

18 ‘‘(4) CATEGORY II DRUGS DEEMED NEW

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

20 safety or effectiveness under a tentative final mono21 graph or that is subject to a determination to be not 

22 safe or effective in a proposed rule that is the most 

23 recently applicable proposal issued under part 330 of 

24 title 21, Code of Federal Regulations, shall be deemed 

25 to be a new drug within the meaning of section 


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1 201(p), misbranded under section 502(ee), and subject 

2 to the requirement for an approved new drug applica3 tion under section 505 beginning on the day that is 

4 180 calendar days after the date of the enactment of 

5 this section, unless, before such day, the Secretary de6 termines that it is in the interest of public health to 

7 extend the period during which the drug may be mar8 keted without such an approved new drug applica9 tion. 

10 ‘‘(5) DRUGS NOT GRASE DEEMED NEW DRUGS.— 

11 A drug that the Secretary has determined not to be 

12 generally recognized as safe and effective within the 

13 meaning of section 201(p)(1) under a final deter14 mination issued under part 330 of title 21, Code of 

15 Federal Regulations, shall be deemed to be a new drug 

16 within the meaning of section 201(p), misbranded 

17 under section 502(ee), and subject to the requirement 

18 for an approved new drug application under section 

19 505. 

20 ‘‘(6) OTHER DRUGS DEEMED NEW DRUGS.—Ex21 cept as provided in subsection (m), a drug is deemed 

22 to be a new drug within the meaning of section 

23 201(p) and misbranded under section 502(ee) if the 

24 drug— 

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


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

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

3 ‘‘(b) ADMINISTRATIVE ORDERS.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) DETERMINATION.—The Secretary 

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

7 request of one or more requestors, issue adminis8 trative orders determining whether there are con9 ditions under which specific drugs, classes of 

10 such drugs, or combinations of such drugs are 

11 determined to be— 

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

13 and 

14 ‘‘(ii) generally recognized as safe and 

15 effective within the meaning of section 

16 201(p)(1). 

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

18 drugs shall be deemed to not require approval 

19 under section 505 if such drug or combination of 

20 drugs— 

21 ‘‘(i) is determined by the Secretary to 

22 meet the conditions specified in clauses (i) 

23 and (ii) of subparagraph (A); 


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1 ‘‘(ii) is marketed in conformity with 

2 an administrative order under this sub3 section; 

4 ‘‘(iii) meets the general requirements 

5 for nonprescription drugs; and 

6 ‘‘(iv) meets the requirements under 

7 subsections (c) and (k). 

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

9 that a drug is not generally recognized as safe 

10 and effective within the meaning of section 

11 201(p)(1) if— 

12 ‘‘(i) the evidence shows that the drug is 

13 not generally recognized as safe and effective 

14 within the meaning of section 201(p)(1); or 

15 ‘‘(ii) the evidence is inadequate to show 

16 that the drug is generally recognized as safe 

17 and effective within the meaning of section 

18 201(p)(1). 

19 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY

20 THE SECRETARY.— 

21 ‘‘(A) IN GENERAL.—In issuing an adminis22 trative order under paragraph (1) upon the Sec23 retary’s initiative, the Secretary shall— 

24 ‘‘(i) make reasonable efforts to notify 

25 informally, not later than 2 business days 


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1 before the issuance of the proposed order, the 

2 sponsors of drugs who have a listing in ef3 fect under section 510(j) for the drugs or 

4 combination of drugs that will be subject to 

5 the administrative order; 

6 ‘‘(ii) after any such reasonable efforts 

7 of notification— 

8 ‘‘(I) issue a proposed administra9 tive order by publishing it on the 

10 website of the Food and Drug Adminis11 tration and include in such order the 

12 reasons for the issuance of such order; 

13 and 

14 ‘‘(II) publish a notice of avail15 ability of such proposed order in the 

16 Federal Register; 

17 ‘‘(iii) except as provided in subpara18 graph (B), provide for a public comment 

19 period with respect to such proposed order 

20 of not less than 45 calendar days; and 

21 ‘‘(iv) if, after completion of the pro22 ceedings specified in clauses (i) through 

23 (iii), the Secretary determines that it is ap24 propriate to issue a final administrative 

25 order— 


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1 ‘‘(I) issue the final administrative 

2 order, together with a detailed state3 ment of reasons, which order shall not 

4 take effect until the time for requesting 

5 judicial review under paragraph 

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

7 ‘‘(II) publish a notice of such 

8 final administrative order in the Fed9 eral Register; 

10 ‘‘(III) afford requestors of drugs 

11 that will be subject to such order the 

12 opportunity for formal dispute resolu13 tion up to the level of the Director of 

14 the Center for Drug Evaluation and 

15 Research, which initially must be re16 quested within 45 calendar days of the 

17 issuance of the order, and, for subse18 quent levels of appeal, within 30 cal19 endar days of the prior decision; and 

20 ‘‘(IV) except with respect to drugs 

21 described in paragraph (3)(B), upon 

22 completion of the formal dispute reso23 lution procedure, inform the persons 

24 which sought such dispute resolution of 

25 their right to request a hearing. 


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1 ‘‘(B) EXCEPTIONS.—When issuing an ad2 ministrative order under paragraph (1) on the 

3 Secretary’s initiative proposing to determine 

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

5 generally recognized as safe and effective within 

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

7 shall follow the procedures in subparagraph (A), 

8 except that— 

9 ‘‘(i) the proposed order shall include 

10 notice of— 

11 ‘‘(I) the general categories of data 

12 the Secretary has determined necessary 

13 to establish that the drug is generally 

14 recognized as safe and effective within 

15 the meaning of section 201(p)(1); and 

16 ‘‘(II) the format for submissions 

17 by interested persons; 

18 ‘‘(ii) the Secretary shall provide for a 

19 public comment period of no less than 180 

20 calendar days with respect to such proposed 

21 order, except when the Secretary determines, 

22 for good cause, that a shorter period is in 

23 the interests of public health; and 

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

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1 cation that the person has submitted all evi2 dence created, obtained, or received by that 

3 person that is both within the categories of 

4 data identified in the proposed order and 

5 relevant to a determination as to whether 

6 the drug is generally recognized as safe and 

7 effective within the meaning of section 

8 201(p)(1). 

9 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

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

11 participated in each stage of formal dispute reso12 lution under subclause (III) of paragraph 

13 (2)(A)(iv) of an administrative order with re14 spect to a drug may request a hearing con15 cerning a final administrative order issued 

16 under such paragraph with respect to such drug. 

17 Such person must submit a request for a hear18 ing, which shall be based solely on information 

19 in the administrative record, to the Secretary 

20 not later than 30 calendar days after receiving 

21 notice of the final decision of the formal dispute 

22 resolution procedure. 

23 ‘‘(B) NO HEARING REQUIRED WITH RE24 SPECT TO ORDERS RELATING TO CERTAIN

25 DRUGS.— 


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1 ‘‘(i) IN GENERAL.—The Secretary shall 

2 not be required to provide notice and an op3 portunity for a hearing pursuant to para4 graph (2)(A)(iv) if the final administrative 

5 order involved relates to a drug— 

6 ‘‘(I) that is described in subsection 

7 (a)(3)(A); and 

8 ‘‘(II) with respect to which no 

9 human or non-human data studies rel10 evant to the safety or effectiveness of 

11 such drug have been submitted to the 

12 administrative record since the 

13 issuance of the most recent tentative 

14 final monograph relating to such drug. 

15 ‘‘(ii) HUMAN DATA STUDIES AND NON16 HUMAN DATA DEFINED.—In this subpara17 graph: 

18 ‘‘(I) The term ‘human data stud19 ies’ means clinical trials of safety or 

20 effectiveness (including actual use stud21 ies), pharmacokinetics studies, or bio22 availability studies. 

23 ‘‘(II) The term ‘non-human data’ 

24 means data from testing other than 

25 with human subjects which provides 


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1 information concerning safety or effec2 tiveness. 

3 ‘‘(C) HEARING PROCEDURES.— 

4 ‘‘(i) DENIAL OF REQUEST FOR HEAR5 ING.—If the Secretary determines that in6 formation submitted in a request for a hear7 ing under subparagraph (A) with respect to 

8 a final administrative order issued under 

9 paragraph (2)(A)(iv), does not identify the 

10 existence of a genuine and substantial ques11 tion of material fact, the Secretary may 

12 deny such request. In making such a deter13 mination, the Secretary may consider only 

14 information and data that are based on rel15 evant and reliable scientific principles and 

16 methodologies. 

17 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

18 RELATED REQUESTS.—If more than one re19 quest for a hearing is submitted with re20 spect to the same administrative order 

21 under subparagraph (A), the Secretary may 

22 direct that a single hearing be conducted in 

23 which all persons whose hearing requests 

24 were granted may participate. 


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1 ‘‘(iii) PRESIDING OFFICER.—The pre2 siding officer of a hearing requested under 

3 subparagraph (A) shall— 

4 ‘‘(I) be designated by the Sec5 retary; 

6 ‘‘(II) not be an employee of the 

7 Center for Drug Evaluation and Re8 search; and 

9 ‘‘(III) not have been previously 

10 involved in the development of the ad11 ministrative order involved or pro12 ceedings relating to that administra13 tive order. 

14 ‘‘(iv) RIGHTS OF PARTIES TO HEAR15 ING.—The parties to a hearing requested 

16 under subparagraph (A) shall have the right 

17 to present testimony, including testimony of 

18 expert witnesses, and to cross-examine wit19 nesses presented by other parties. Where ap20 propriate, the presiding officer may require 

21 that cross-examination by parties rep22 resenting substantially the same interests be 

23 consolidated to promote efficiency and avoid 

24 duplication. 

25 ‘‘(v) FINAL DECISION.— 


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1 ‘‘(I) At the conclusion of a hear2 ing requested under subparagraph (A), 

3 the presiding officer of the hearing 

4 shall issue a decision containing find5 ings of fact and conclusions of law. The 

6 decision of the presiding officer shall be 

7 final. 

8 ‘‘(II) The final decision may not 

9 take effect until the period under sub10 paragraph (D)(ii) for submitting a re11 quest for judicial review of such deci12 sion expires. 

13 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMINIS14 TRATIVE ORDER.— 

15 ‘‘(i) IN GENERAL.—The procedures de16 scribed in section 505(h) shall apply with 

17 respect to judicial review of final adminis18 trative orders issued under this subsection 

19 in the same manner and to the same extent 

20 as such section applies to an order described 

21 in such section except that the judicial re22 view shall be taken by filing in an appro23 priate district court of the United States in 

24 lieu of the appellate courts specified in such 

25 section. 


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1 ‘‘(ii) PERIOD TO SUBMIT A REQUEST

2 FOR JUDICIAL REVIEW.—A person eligible 

3 to request a hearing under this paragraph 

4 and seeking judicial review of a final ad5 ministrative order issued under this sub6 section shall file such request for judicial re7 view not later than 60 calendar days after 

8 the latest of— 

9 ‘‘(I) the date on which notice of 

10 such order is published; 

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

12 with respect to such order is denied 

13 under subparagraph (B) or (C)(i); 

14 ‘‘(III) the date on which a final 

15 decision is made following a hearing 

16 under subparagraph (C)(v); or 

17 ‘‘(IV) if no hearing is requested, 

18 the date on which the time for request19 ing a hearing expires. 

20 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT TO

21 ADMINISTRATIVE ORDERS INITIATED BY THE SEC22 RETARY.— 

23 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

24 HEALTH.— 


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1 ‘‘(i) IN GENERAL.—In the case of a de2 termination by the Secretary that a drug, 

3 class of drugs, or combination of drugs sub4 ject to this section poses an imminent haz5 ard to the public health, the Secretary, after 

6 first making reasonable efforts to notify, not 

7 later than 48 hours before issuance of such 

8 order under this subparagraph, sponsors 

9 who have a listing in effect under section 

10 510(j) for such drug or combination of 

11 drugs— 

12 ‘‘(I) may issue an interim final 

13 administrative order for such drug, 

14 class of drugs, or combination of drugs 

15 under paragraph (1), together with a 

16 detailed statement of the reasons for 

17 such order; 

18 ‘‘(II) shall publish in the Federal 

19 Register a notice of availability of any 

20 such order; and 

21 ‘‘(III) shall provide for a public 

22 comment period of at least 45 calendar 

23 days with respect to such interim final 

24 order. 


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1 ‘‘(ii) NONDELEGATION.—The Secretary 

2 may not delegate the authority to issue an 

3 interim final administrative order under 

4 this subparagraph. 

5 ‘‘(B) SAFETY LABELING CHANGES.— 

6 ‘‘(i) IN GENERAL.—In the case of a de7 termination by the Secretary that a change 

8 in the labeling of a drug, class of drugs, or 

9 combination of drugs subject to this section 

10 is reasonably expected to mitigate a signifi11 cant or unreasonable risk of a serious ad12 verse event associated with use of the drug, 

13 the Secretary may— 

14 ‘‘(I) make reasonable efforts to no15 tify informally, not later than 48 hours 

16 before the issuance of the interim final 

17 order, the sponsors of drugs who have 

18 a listing in effect under section 510(j) 

19 for such drug or combination of drugs; 

20 ‘‘(II) after reasonable efforts of no21 tification, issue an interim final ad22 ministrative order in accordance with 

23 paragraph (1) to require such change, 

24 together with a detailed statement of 

25 the reasons for such order; 


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1 ‘‘(III) publish in the Federal Reg2 ister a notice of availability of such 

3 order; and 

4 ‘‘(IV) provide for a public com5 ment period of at least 45 calendar 

6 days with respect to such interim final 

7 order. 

8 ‘‘(ii) CONTENT OF ORDER.—An in9 terim final order issued under this subpara10 graph with respect to the labeling of a drug 

11 may provide for new warnings and other 

12 information required for safe use of the 

13 drug. 

14 ‘‘(C) EFFECTIVE DATE.—An order under 

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

16 date specified by the Secretary. 

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

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

19 the Secretary shall— 

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

21 with paragraph (1); 

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

23 such final administrative order in the Fed24 eral Register; and 


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1 ‘‘(iii) afford sponsors of such drugs 

2 that will be subject to such an order the op3 portunity for formal dispute resolution up 

4 to the level of the Director of the Center for 

5 Drug Evaluation and Research, which must 

6 initially be within 45 calendar days of the 

7 issuance of the order, and for subsequent 

8 levels of appeal, within 30 calendar days of 

9 the prior decision. 

10 ‘‘(E) HEARINGS.—A sponsor of a drug sub11 ject to a final order issued under subparagraph 

12 (D) and that participated in each stage of for13 mal dispute resolution under clause (iii) of such 

14 subparagraph may request a hearing on such 

15 order. The provisions of subparagraphs (A), (B), 

16 and (C) of paragraph (3), other than paragraph 

17 (3)(C)(v)(II), shall apply with respect to a hear18 ing on such order in the same manner and to the 

19 same extent as such provisions apply with re20 spect to a hearing on an administrative order 

21 issued under paragraph (2)(A)(iv). 

22 ‘‘(F) TIMING.— 

23 ‘‘(i) FINAL ORDER AND HEARING.—The 

24 Secretary shall— 


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1 ‘‘(I) not later than 6 months after 

2 the date on which the comment period 

3 closes under subparagraph (A) or (B), 

4 issue a final order in accordance with 

5 paragraph (1); and 

6 ‘‘(II) not later than 12 months 

7 after the date on which such final 

8 order is issued, complete any hearing 

9 under subparagraph (E). 

10 ‘‘(ii) DISPUTE RESOLUTION RE11 QUEST.—The Secretary shall specify in an 

12 interim final order issued under subpara13 graph (A) or (B) such shorter periods for 

14 requesting dispute resolution under sub15 paragraph (D)(iii) as are necessary to meet 

16 the requirements of this subparagraph. 

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

18 issued pursuant to subparagraph (F) shall be 

19 subject to judicial review in accordance with 

20 paragraph (3)(D). 

21 ‘‘(5) ADMINISTRATIVE ORDER INITIATED AT THE

22 REQUEST OF A REQUESTOR.— 

23 ‘‘(A) IN GENERAL.—In issuing an adminis24 trative order under paragraph (1) at the request 


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1 of a requestor with respect to certain drugs, 

2 classes of drugs, or combinations of drugs— 

3 ‘‘(i) the Secretary shall, after receiving 

4 a request under this subparagraph, deter5 mine whether the request is sufficiently 

6 complete and formatted to permit a sub7 stantive review; 

8 ‘‘(ii) if the Secretary determines that 

9 the request is sufficiently complete and for10 matted to permit a substantive review, the 

11 Secretary shall— 

12 ‘‘(I) file the request; and 

13 ‘‘(II) initiate proceedings with re14 spect to issuing an administrative 

15 order in accordance with paragraphs 

16 (2) and (3); and 

17 ‘‘(iii) except as provided in paragraph 

18 (6), if the Secretary determines that a re19 quest does not meet the requirements for fil20 ing or is not sufficiently complete and for21 matted to permit a substantive review, the 

22 requestor may demand that the request be 

23 filed over protest, and the Secretary shall 

24 initiate proceedings to review the request in 

25 accordance with paragraph (2)(A). 


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1 ‘‘(B) REQUEST TO INITIATE PRO2 CEEDINGS.— 

3 ‘‘(i) IN GENERAL.—A requestor seeking 

4 an administrative order under paragraph 

5 (1) with respect to certain drugs, classes of 

6 drugs, or combinations of drugs, shall sub7 mit to the Secretary a request to initiate 

8 proceedings for such order in the form and 

9 manner as specified by the Secretary. Such 

10 requestor may submit a request under this 

11 subparagraph for the issuance of an admin12 istrative order— 

13 ‘‘(I) determining whether a drug 

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

16 201(p)(1), exempt from section 

17 503(b)(1), and not required to be the 

18 subject of an approved application 

19 under section 505; or 

20 ‘‘(II) determining whether a 

21 change to a condition of use of a drug 

22 is generally recognized as safe and ef23 fective within the meaning of section 

24 201(p)(1), exempt from section 

25 503(b)(1), and not required to be the 


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1 subject of an approved application 

2 under section 505, if, absent such a 

3 changed condition of use, such drug 

4 is— 

5 ‘‘(aa) generally recognized as 

6 safe and effective within the 

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

8 accordance with subsection (a)(1), 

9 (a)(2), or an order under this sub10 section; or 

11 ‘‘(bb) subject to subsection 

12 (a)(3), but only if such requestor 

13 initiates such request in conjunc14 tion with a request for the Sec15 retary to determine whether such 

16 drug is generally recognized as 

17 safe and effective within the 

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

19 which is filed by the Secretary 

20 under subparagraph (A)(ii). 

21 ‘‘(ii) EXCEPTION.—The Secretary is 

22 not required to complete review of a request 

23 for a change described in clause (i)(II) if 

24 the Secretary determines that there is an 

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1 erally recognized as safe and effective with2 in the meaning of section 201(p)(1) under 

3 paragraph (1) and issues a final order an4 nouncing that determination. 

5 ‘‘(iii) WITHDRAWAL.—The requestor 

6 may withdraw a request under this para7 graph, according to the procedures set forth 

8 pursuant to subsection (d)(2)(B). Notwith9 standing any other provision of this section, 

10 if such request is withdrawn, the Secretary 

11 may cease proceedings under this subpara12 graph. 

13 ‘‘(C) EXCLUSIVITY.— 

14 ‘‘(i) IN GENERAL.—A final adminis15 trative order issued in response to a request 

16 under this section shall have the effect of au17 thorizing solely the order requestor (or the 

18 licensees, assignees, or successors in interest 

19 of such requestor with respect to the subject 

20 of such order), for a period of 18 months 

21 following the effective date of such final 

22 order, to market drugs— 

23 ‘‘(I) incorporating changes de24 scribed in clause (ii); 


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1 ‘‘(II) beginning on the date the re2 questor (or any such licensees, assign3 ees, or successors in interest) may law4 fully market such drugs pursuant to 

5 the order; and 

6 ‘‘(III) subject to the limitations 

7 under clause (iv). 

8 ‘‘(ii) CHANGES DESCRIBED.—A change 

9 described in this clause is a change subject 

10 to an order specified in clause (i), which— 

11 ‘‘(I) provides for a drug to con12 tain an active ingredient (including 

13 any ester or salt of the active ingre14 dient) not previously incorporated in a 

15 drug described in clause (iii); or 

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

17 conditions of use of a drug, for which 

18 new human data studies conducted or 

19 sponsored by the requestor (or for 

20 which the requestor has an exclusive 

21 right of reference) were essential to the 

22 issuance of such order. 

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

24 described in this clause are drugs— 


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1 ‘‘(I) specified in subsection (a)(1), 

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

3 ‘‘(II) subject to a final order 

4 issued under this section; 

5 ‘‘(III) subject to a final sunscreen 

6 order (as defined in section 586(2)(A)); 

7 or 

8 ‘‘(IV) described in subsection 

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

10 active enforcement action under chap11 ter III of this Act. 

12 ‘‘(iv) LIMITATIONS ON EXCLUSIVITY.— 

13 ‘‘(I) IN GENERAL.—Only one pe14 riod of exclusivity shall be granted, 

15 under each order described in clause 

16 (i), with respect to changes (to the drug 

17 subject to such order) which are ei18 ther— 

19 ‘‘(aa) changes described in 

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

21 ingredients; or 

22 ‘‘(bb) changes described in 

23 clause (ii)(II), relating to condi24 tions of use. 


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1 ‘‘(II) NO EXCLUSIVITY AL2 LOWED.—No exclusivity shall apply to 

3 changes to a drug which are— 

4 ‘‘(aa) the subject of a Tier 2 

5 OTC monograph order request (as 

6 defined in section 744N); 

7 ‘‘(bb) safety-related changes, 

8 as defined by the Secretary, or 

9 any other changes the Secretary 

10 considers necessary to assure safe 

11 use; or 

12 ‘‘(cc) changes related to 

13 methods of testing safety or effi14 cacy. 

15 ‘‘(v) NEW HUMAN DATA STUDIES DE16 FINED.—In this subparagraph, the term 

17 ‘new human data studies’ means clinical 

18 trials of safety or effectiveness (including 

19 actual use studies), pharmacokinetics stud20 ies, or bioavailability studies, the results of 

21 which— 

22 ‘‘(I) have not been relied on by the 

23 Secretary to support— 

24 ‘‘(aa) a proposed or final de25 termination that a drug described 


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

2 clause (iii) is generally recognized 

3 as safe and effective within the 

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

5 ‘‘(bb) approval of a drug that 

6 was approved under section 505; 

7 and 

8 ‘‘(II) do not duplicate the results 

9 of another study that was relied on by 

10 the Secretary to support— 

11 ‘‘(aa) a proposed or final de12 termination that a drug described 

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

14 clause (iii) is generally recognized 

15 as safe and effective within the 

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

17 ‘‘(bb) approval of a drug that 

18 was approved under section 505. 

19 ‘‘(vi) EFFECTIVE DATE.—A final order 

20 subject to clause (i) shall take effect on the 

21 date when the order requestor (or the licens22 ees, assignees, or successors in interest of 

23 such requestor with respect to such order) 

24 submits updated drug listing information 


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1 under subsection (e) with respect to the 

2 change which is permitted under such order. 

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

4 years after the date of enactment of the 

5 Over-the-Counter Monograph, Safety, Inno6 vation, and Reform Act of 2018, the Comp7 troller General of the United States shall 

8 submit a study to the Committee on Energy 

9 and Commerce of the House of Representa10 tives and the Committee on Health, Edu11 cation, Labor, and Pensions of the Senate 

12 addressing the effectiveness and overall im13 pact of exclusivity under this section, in14 cluding its impact on consumer access. 

15 Such study shall include— 

16 ‘‘(I) the number of nonprescrip17 tion drug products that were granted 

18 exclusivity and the indication for 

19 which the nonprescription drug prod20 ucts were determined to be generally 

21 recognized as safe and effective; 

22 ‘‘(II) whether the exclusivity for 

23 such drug products was granted for— 


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1 ‘‘(aa) a new active ingredient 

2 (including any ester or salt of the 

3 active ingredient); or 

4 ‘‘(bb) changes in the condi5 tions of use of a drug, for which 

6 new human data studies con7 ducted or sponsored by the re8 questor were essential; 

9 ‘‘(III) whether, and to what ex10 tent, the exclusivity impacted the re11 questor’s or sponsor’s decision to de12 velop the drug product; 

13 ‘‘(IV) an analysis of the imple14 mentation of the exclusivity provision 

15 in this subparagraph, including— 

16 ‘‘(aa) the resources used by 

17 the Food and Drug Administra18 tion; 

19 ‘‘(bb) the impact of such pro20 vision on innovation, as well as 

21 research and development in the 

22 nonprescription drug market; 

23 ‘‘(cc) the impact of such pro24 vision on competition in the non25 prescription drug market; 


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1 ‘‘(dd) the impact of such pro2 vision on consumer access to non3 prescription drug products; 

4 ‘‘(ee) the impact of such pro5 vision on the prices of non6 prescription drug products; and 

7 ‘‘(ff) whether the administra8 tive orders initiated by requestors 

9 under this section have been suffi10 cient to encourage the development 

11 of nonprescription drug products 

12 that would likely not be otherwise 

13 developed, or developed in as 

14 timely a manner; and 

15 ‘‘(V) whether the administrative 

16 orders initiated by requestors under 

17 this section have been sufficient incen18 tive to encourage innovation in the 

19 nonprescription drug market. 

20 ‘‘(6) INFORMATION REGARDING SAFE NON21 PRESCRIPTION MARKETING AND USE AS CONDITION

22 FOR FILING A GENERALLY RECOGNIZED AS SAFE AND

23 EFFECTIVE REQUEST.— 

24 ‘‘(A) IN GENERAL.—In response to a request 

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1 paragraph (B) be generally recognized as safe 

2 and effective, the Secretary— 

3 ‘‘(i) may file such request, if the re4 quest includes information specified under 

5 subparagraph (C) with respect to safe non6 prescription marketing and use of such 

7 drug; or 

8 ‘‘(ii) if the request fails to include in9 formation specified under subparagraph 

10 (C), shall refuse to file such request and re11 quire that nonprescription marketing of the 

12 drug be pursuant to a new drug application 

13 as described in subparagraph (D). 

14 ‘‘(B) DRUG DESCRIBED.—A drug described 

15 in this subparagraph is a nonprescription drug 

16 which contains an active ingredient not pre17 viously incorporated in a drug— 

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

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

20 ‘‘(ii) subject to a final order under this 

21 section; or 

22 ‘‘(iii) subject to a final sunscreen order 

23 (as defined in section 586(2)(A)). 

24 ‘‘(C) INFORMATION DEMONSTRATING PRIMA

25 FACIE SAFE NONPRESCRIPTION MARKETING AND


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1 USE.—Information specified in this subpara2 graph, with respect to a request described in sub3 paragraph (A)(i), is— 

4 ‘‘(i) information sufficient for a prima 

5 facie demonstration that the drug subject to 

6 such request has a verifiable history of being 

7 marketed and safely used by consumers in 

8 the United States as a nonprescription drug 

9 under comparable conditions of use; 

10 ‘‘(ii) if the drug has not been pre11 viously marketed in the United States as a 

12 nonprescription drug, information sufficient 

13 for a prima facie demonstration that the 

14 drug was marketed and safely used under 

15 comparable conditions of marketing and use 

16 in a country listed in section 802(b)(1)(A) 

17 or designated by the Secretary in accord18 ance with section 802(b)(1)(B)— 

19 ‘‘(I) for such period of time as 

20 needed to provide reasonable assur21 ances concerning the safe nonprescrip22 tion use of the drug; and 

23 ‘‘(II) during such time was sub24 ject to sufficient monitoring by a regu25 latory body considered acceptable by 


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1 the Secretary for such monitoring pur2 poses, including for adverse events as3 sociated with nonprescription use of 

4 the drug; or 

5 ‘‘(iii) if the Secretary determines that 

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

7 is not needed to provide a prima facie dem8 onstration that the drug can be safely mar9 keted and used as a nonprescription drug, 

10 such other information the Secretary deter11 mines is sufficient for such purposes. 

12 ‘‘(D) MARKETING PURSUANT TO NEW DRUG

13 APPLICATION.—In the case of a request described 

14 in subparagraph (A)(ii), the drug subject to such 

15 request may be re-submitted for filing only if— 

16 ‘‘(i) the drug is marketed as a non17 prescription drug, under conditions of use 

18 comparable to the conditions specified in 

19 the request, for such period of time as the 

20 Secretary determines appropriate (not to 

21 exceed five consecutive years) pursuant to 

22 an application approved under section 505; 

23 and 

24 ‘‘(ii) during such time period, one mil25 lion retail packages of the drug, or an 


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1 equivalent quantity as determined by the 

2 Secretary, were distributed for retail sale, 

3 as determined in such manner as the Sec4 retary finds appropriate. 

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

6 the case of a request involving a drug described 

7 in section 586(9), as in effect on January 1, 

8 2017, if the Secretary refuses to file a request 

9 under this paragraph, the requestor may not file 

10 such request over protest under paragraph 

11 (5)(A)(iii). 

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

13 issued under paragraph (2), (4)(A), or (5) may in14 clude requirements for the packaging of a drug to en15 courage use in accordance with labeling. Such re16 quirements may include unit dose packaging, require17 ments for products intended for use by children, re18 quirements to reduce risk of harm from unsupervised 

19 ingestion, and other appropriate requirements. This 

20 paragraph does not authorize the Food and Drug Ad21 ministration to require standards or testing proce22 dures as described in part 1700 of title 16, Code of 

23 Federal Regulations. 


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1 ‘‘(8) FINAL AND TENTATIVE FINAL MONOGRAPHS

2 FOR CATEGORY I DRUGS DEEMED FINAL ADMINISTRA3 TIVE ORDERS.— 

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

5 tentative final monograph described in subpara6 graph (B) shall be deemed to be a final adminis7 trative order under this subsection and may be 

8 amended, revoked, or otherwise modified in ac9 cordance with the procedures of this subsection. 

10 ‘‘(B) MONOGRAPHS DESCRIBED.—For pur11 poses of subparagraph (A), a final monograph or 

12 tentative final monograph is described in this 

13 subparagraph if it— 

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

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

16 subsection (a); and 

17 ‘‘(ii) represents the most recently pro18 mulgated version of such conditions, includ19 ing as modified, in whole or in part, by 

20 any proposed or final rule. 

21 ‘‘(C) DEEMED ORDERS INCLUDE HARMO22 NIZING TECHNICAL AMENDMENTS.—The deemed 

23 establishment of a final administrative order 

24 under subparagraph (A) shall be construed to in25 clude any technical amendments to such order as 


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1 the Secretary determines necessary to ensure that 

2 such order is appropriately harmonized, in 

3 terms of terminology or cross-references, with the 

4 applicable provisions of this Act (and regulations 

5 thereunder) and any other orders issued under 

6 this section. 

7 ‘‘(c) PROCEDURE FOR MINOR CHANGES.— 

8 ‘‘(1) IN GENERAL.—Minor changes in the dosage 

9 form of a drug that is described in paragraph (1) or 

10 (2) of subsection (a) or the subject of an order issued 

11 under subsection (b) may be made by a requestor 

12 without the issuance of an order under subsection (b) 

13 if— 

14 ‘‘(A) the requestor maintains such informa15 tion as is necessary to demonstrate that the 

16 change— 

17 ‘‘(i) will not affect the safety or effec18 tiveness of the drug; and 

19 ‘‘(ii) will not materially affect the ex20 tent of absorption or other exposure to the 

21 active ingredient in comparison to a suit22 able reference product; and 

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

24 requirements of an applicable administrative 


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1 order issued by the Secretary under paragraph 

2 (3). 

3 ‘‘(2) ADDITIONAL INFORMATION.— 

4 ‘‘(A) ACCESS TO RECORDS.—A sponsor 

5 shall submit records requested by the Secretary 

6 relating to such a minor change under section 

7 704(a)(4), within 15 business days of receiving 

8 such a request, or such longer period as the Sec9 retary may provide. 

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

11 Secretary determines that the information con12 tained in such records is not sufficient to dem13 onstrate that the change does not affect the safety 

14 or effectiveness of the drug or materially affect 

15 the extent of absorption or other exposure to the 

16 active ingredient, the Secretary— 

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

18 drug in writing; and 

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

20 with a reasonable opportunity to provide 

21 additional information. 

22 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN23 FORMATION.—If the sponsor fails to provide such 

24 additional information within the prescribed 

25 time, or if the Secretary determines that such 


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1 additional information does not demonstrate 

2 that the change does not affect the safety or effec3 tiveness of the drug or materially affect the ex4 tent of absorption or other exposure to the active 

5 ingredient, the drug as modified is a new drug 

6 within the meaning of section 201(p) and shall 

7 be deemed to be misbranded under section 

8 502(ee). 

9 ‘‘(3) DETERMINING WHETHER A CHANGE WILL

10 AFFECT SAFETY OR EFFECTIVENESS.— 

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

12 issue one or more administrative orders speci13 fying requirements for determining whether a 

14 minor change made by a sponsor pursuant to 

15 this subsection will affect the safety or effective16 ness of a drug or materially affect the extent of 

17 absorption or other exposure to an active ingre18 dient in the drug in comparison to a suitable 

19 reference product, together with guidance for ap20 plying those orders to specific dosage forms. 

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

22 and guidance issued by the Secretary under sub23 paragraph (A) shall take into account relevant 

24 public standards and standard practices for 

25 evaluating the quality of drugs, and may take 


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1 into account the special needs of populations, in2 cluding children. 

3 ‘‘(d) CONFIDENTIALITY OF INFORMATION SUBMITTED

4 TO THE SECRETARY.— 

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

6 any information, including reports of testing con7 ducted on the drug or drugs involved, that is sub8 mitted by a requestor in connection with proceedings 

9 on an order under this section (including any minor 

10 change under subsection (c)) and is a trade secret or 

11 confidential information subject to section 552(b)(4) 

12 of title 5, United States Code, or section 1905 of title 

13 18, United States Code, shall not be disclosed to the 

14 public unless the requestor consents to that disclosure. 

15 ‘‘(2) PUBLIC AVAILABILITY.— 

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

17 subparagraph (B), the Secretary shall— 

18 ‘‘(i) make any information submitted 

19 by a requestor in support of a request under 

20 subsection (b)(5)(A) available to the public 

21 not later than the date on which the pro22 posed order is issued; and 

23 ‘‘(ii) make any information submitted 

24 by any other person with respect to an 

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1 retary) under subsection (b), available to 

2 the public upon such submission. 

3 ‘‘(B) LIMITATIONS ON PUBLIC AVAIL4 ABILITY.—Information described in subpara5 graph (A) shall not be made public if— 

6 ‘‘(i) the information pertains to phar7 maceutical quality information, unless such 

8 information is necessary to establish stand9 ards under which a drug is generally recog10 nized as safe and effective within the mean11 ing of section 201(p)(1); 

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

13 requestor-initiated request, but the requestor 

14 withdraws such request, in accordance with 

15 withdrawal procedures established by the 

16 Secretary, before the Secretary issues the 

17 proposed order; 

18 ‘‘(iii) the Secretary requests and ob19 tains the information under subsection (c) 

20 and such information is not submitted in 

21 relation to an order under subsection (b); or 

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

23 contained in raw datasets. 

24 ‘‘(e) UPDATES TO DRUG LISTING INFORMATION.—A 

25 sponsor who makes a change to a drug subject to this section 


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1 shall submit updated drug listing information for the drug 

2 in accordance with section 510(j) within 30 calendar days 

3 of the date when the drug is first commercially marketed, 

4 except that a sponsor who was the order requestor with re5 spect to an order subject to subsection (b)(5)(C) (or a li6 censee, assignee, or successor in interest of such requestor) 

7 shall submit updated drug listing information on or before 

8 the date when the drug is first commercially marketed. 

9 ‘‘(f) APPROVALS UNDER SECTION 505.—The provi10 sions of this section shall not be construed to preclude a 

11 person from seeking or maintaining the approval of a drug 

12 under sections 505(b)(1), 505(b)(2), and 505(j). A deter13 mination under this section that a drug is not subject to 

14 section 503(b)(1), is generally recognized as safe and effec15 tive within the meaning of section 201(p)(1), and is not 

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

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

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

19 that the applicant shall be required to submit for purposes 

20 of such application only information needed to support any 

21 modification of the drug that is not covered by such deter22 mination under this section. 

23 ‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR24 DERS.—The Secretary shall establish, maintain, update (as 

25 determined necessary by the Secretary but no less frequently 


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1 than annually), and make publicly available, with respect 

2 to orders issued under this section— 

3 ‘‘(1) a repository of each final order and interim 

4 final order in effect, including the complete text of the 

5 order; and 

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

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

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

9 and 

10 ‘‘(B) the Secretary’s expectations, if re11 sources permit, for issuance of proposed orders 

12 over a three-year period. 

13 ‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE14 QUESTORS.—The Secretary shall establish procedures under 

15 which sponsors or requestors may meet with appropriate 

16 officials of the Food and Drug Administration to obtain 

17 advice on the studies and other information necessary to 

18 support submissions under this section and other matters 

19 relevant to the regulation of nonprescription drugs and the 

20 development of new nonprescription drugs under this sec21 tion. 

22 ‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE23 QUESTORS.—The Secretary shall establish procedures to fa24 cilitate efficient participation by multiple sponsors or re25 questors in proceedings under this section, including proviVerDate Sep 11 2014 22:29 Jul 16, 2018 Jkt 079200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6203 E:\BILLS\H5333.RH H5333

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1 sion for joint meetings with multiple sponsors or requestors 

2 or with organizations nominated by sponsors or requestors 

3 to represent their interests in a proceeding. 

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

5 this section shall be in electronic format. 

6 ‘‘(k) EFFECT ON EXISTING REGULATIONS GOVERNING

7 NONPRESCRIPTION DRUGS.— 

8 ‘‘(1) REGULATIONS OF GENERAL APPLICABILITY

9 TO NONPRESCRIPTION DRUGS.—Except as provided in 

10 this subsection, nothing in this section supersedes reg11 ulations establishing general requirements for non12 prescription drugs, including regulations of general 

13 applicability contained in parts 201, 250, and 330 of 

14 title 21, Code of Federal Regulations, or any successor 

15 regulations. The Secretary shall establish or modify 

16 such regulations by means of rulemaking in accord17 ance with section 553 of title 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 effect 

22 on the day before the date of the enactment of 

23 this section, shall be deemed to be a final order 

24 under subsection (b). 


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1 ‘‘(B) Regulations in effect on the day before 

2 the date of the enactment of this section, estab3 lishing requirements for specific nonprescription 

4 drugs marketed pursuant to this section (includ5 ing such requirements in parts 201 and 250 of 

6 title 21, Code of Federal Regulations), shall be 

7 deemed to be final orders under subsection (b), 

8 only as they apply to drugs— 

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

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

11 ‘‘(ii) otherwise subject to an order 

12 under this section. 

13 ‘‘(3) WITHDRAWAL OF REGULATIONS.—The Sec14 retary shall withdraw regulations establishing final 

15 monographs and the procedures governing the over16 the-counter drug review under part 330 and other rel17 evant parts of title 21, Code of Federal Regulations 

18 (as in effect on the day before the date of the enact19 ment of this section), or make technical changes to 

20 such regulations to ensure conformity with appro21 priate terminology and cross references. Notwith22 standing subchapter II of chapter 5 of title 5, United 

23 States Code, any such withdrawal or technical 

24 changes shall be made without public notice and com25 ment and shall be effective upon publication through 


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1 notice in the Federal Register (or upon such date as 

2 specified in such notice). 

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

4 that specifies— 

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

6 meetings between the Secretary and sponsors or re7 questors for drugs subject to this section; 

8 ‘‘(2) the format and content of data submissions 

9 to the Secretary under this section; 

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

11 Secretary under this section; 

12 ‘‘(4) consolidated proceedings and the procedures 

13 for such proceedings where appropriate; and 

14 ‘‘(5) for minor changes in drugs, recommenda15 tions on how to comply with the requirements in or16 ders issued under subsection (c)(3). 

17 ‘‘(m) RULE OF CONSTRUCTION.— 

18 ‘‘(1) IN GENERAL.—This section shall not affect 

19 the treatment or status of a nonprescription drug— 

20 ‘‘(A) that is marketed without an applica21 tion approved under section 505 as of the date 

22 of the enactment of this section; 

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

24 under this section; and 


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

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

3 ‘‘(2) TREATMENT OF PRODUCTS PREVIOUSLY

4 FOUND TO BE SUBJECT TO TIME AND EXTENT RE5 QUIREMENTS.— 

6 ‘‘(A) Notwithstanding subsection (a), a drug 

7 described in subparagraph (B) may only be law8 fully marketed, without an application approved 

9 under section 505, pursuant to an order issued 

10 under this section. 

11 ‘‘(B) A drug described in this subparagraph 

12 is a drug which, prior to the date of the enact13 ment of this section, the Secretary had deter14 mined in a proposed or final rule to be ineligible 

15 for review under the OTC drug review (as such 

16 phrase ‘OTC drug review’ was used in section 

17 330.14 of title 21, Code of Federal Regulations, 

18 as in effect on the day before the date of the en19 actment of this section). 

20 ‘‘(3) PRESERVATION OF AUTHORITY.— 

21 ‘‘(A) Nothing in paragraph (1) shall be con22 strued to preclude or limit the applicability of 

23 any other provision of this Act. 

24 ‘‘(B) Nothing in subsection (a) shall be con25 strued to prohibit the Secretary from issuing an 


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1 order under this section finding a drug to be not 

2 generally recognized as safe and effective within 

3 the meaning of section 201(p)(1), as the Sec4 retary determines appropriate. 

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

6 subject to this section if an exemption for investigational 

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

8 ‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION

9 ACT.—Chapter 35 of title 44, United States Code, shall not 

10 apply to collections of information made under this section. 

11 ‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT

12 RULEMAKING AND OTHER REQUIREMENTS.—The require13 ments of subsection (b) shall apply with respect to orders 

14 issued under this section instead of the requirements of sub15 chapter II of chapter 5 of title 5, United States Code. 

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

17 ‘‘(1) The term ‘nonprescription drug’ refers to a 

18 drug not subject to the requirements of section 

19 503(b)(1). 

20 ‘‘(2) The term ‘sponsor’ refers to any person 

21 marketing, manufacturing, or processing a drug 

22 that— 

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

24 and 


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1 ‘‘(B) is or will be subject to an administra2 tive order of the Food and Drug Administration. 

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

4 group of persons marketing, manufacturing, proc5 essing, or developing a drug.’’. 

6 SEC. 102. MISBRANDING. 

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

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

9 following: 

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

11 section 505G, is not the subject of an application approved 

12 under section 505, and does not comply with the require13 ments under section 505G. 

14 ‘‘(ff) If it is a drug and it was manufactured, pre15 pared, propagated, compounded, or processed in a facility 

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

17 744O.’’. 

18 SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE19 COUNTER DRUG REVIEW. 

20 (a) IN GENERAL.—Nothing in this Act (or the amend21 ments made by this Act) shall apply to any nonprescription 

22 drug which was excluded by the Food and Drug Adminis23 tration from the Over-the-Counter Drug Review in accord24 ance with the statement set out at page 9466 of volume 37 

25 of the Federal Register, published on May 11, 1972. 


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1 (b) RULE OF CONSTRUCTION.—Nothing in this section 

2 shall be construed to preclude or limit the applicability of 

3 any other provision of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 301 et seq.). 

5 SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT. 

6 (a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC7 TIVE INGREDIENTS.— 

8 (1) APPLICABILITY OF SECTION 505G FOR PEND9 ING SUBMISSIONS.— 

10 (A) IN GENERAL.—A sponsor of a non11 prescription sunscreen active ingredient or com12 bination of nonprescription sunscreen active in13 gredients that, as of the date of enactment of this 

14 Act, is subject to a proposed sunscreen order 

15 under section 586C of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 360fff–3) may elect, 

17 by means of giving written notification to the 

18 Secretary of Health and Human Services within 

19 180 calendar days of the enactment of this Act, 

20 to transition into the review of such ingredient 

21 or combination of ingredients pursuant to the 

22 process set out in section 505G of the Federal 

23 Food, Drug, and Cosmetic Act, as added by sec24 tion 101 of this Act. 


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1 (B) ELECTION EXERCISED.—Upon receipt 

2 by the Secretary of Health and Human Services 

3 of a timely notification under subparagraph 

4 (A)— 

5 (i) the proposed sunscreen order in6 volved is deemed to be a request for an order 

7 under subsection (b) of section 505G of the 

8 Federal Food, Drug, and Cosmetic Act, as 

9 added by section 101 of this Act; and 

10 (ii) such order is deemed to have been 

11 accepted for filing under subsection 

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

13 (C) ELECTION NOT EXERCISED.—A sponsor 

14 of a nonprescription sunscreen active ingredient 

15 or combination of nonprescription sunscreen ac16 tive ingredients described in subparagraph (A) 

17 that does not elect for such ingredient or com18 bination of ingredients to be reviewed under sec19 tion 505G of the Federal Food, Drug, and Cos20 metic Act, as added by section 101 of this Act, 

21 shall continue to have such ingredient or com22 bination of ingredients reviewed in accordance 

23 with section 586C of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 360fff–3) and may 

25 not subsequently elect to transition into the reVerDate Sep 11 2014 22:29 Jul 16, 2018 Jkt 079200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6203 E:\BILLS\H5333.RH H5333

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1 view of such ingredient or combination of ingre2 dients pursuant to the process set out in section 

3 505G of such Act, as added by section 101 of this 

4 Act. 

5 (2) DEFINITIONS.—In this subsection, the terms 

6 ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen active in7 gredient’’, and ‘‘proposed sunscreen order’’ have the 

8 meanings given to those terms in section 586 of the 

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

10 360fff). 

11 (b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 

12 (1) FINAL SUNSCREEN ORDERS.—Paragraph (3) 

13 of section 586C(e) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 360fff–3(e)) is amended to 

15 read as follows: 

16 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SECTION

17 505G.—A final sunscreen order shall be deemed to be 

18 a final order under section 505G.’’. 

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

20 586C(b) of the Federal Food, Drug, and Cosmetic Act 

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

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

23 and inserting the following: 

24 ‘‘(A) IN GENERAL.—A sponsor may re25 quest’’; and 


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

2 ‘‘(B) CONFIDENTIAL MEETINGS.—A sponsor 

3 may request one or more confidential meetings 

4 with respect to a proposed sunscreen order, in5 cluding a letter deemed to be a proposed sun6 screen order under paragraph (3), to discuss 

7 matters involving confidential commercial infor8 mation or trade secrets. The Secretary shall con9 vene a confidential meeting with such sponsor in 

10 a reasonable time period. If a sponsor requests 

11 more than one confidential meeting for the same 

12 proposed sunscreen order, the Secretary may 

13 refuse to grant an additional confidential meet14 ing request if the Secretary determines that such 

15 additional confidential meeting is not reasonably 

16 necessary for the sponsor to advance its proposed 

17 sunscreen order, or if the request for a confiden18 tial meeting fails to include sufficient informa19 tion upon which to base a substantive discussion. 

20 The Secretary shall publish a post-meeting sum21 mary of each confidential meeting under this 

22 subparagraph that does not disclose confidential 

23 commercial information or trade secrets.’’. 

24 (3) SUNSET PROVISION.—Subchapter I of chap25 ter V of the Federal Food, Drug, and Cosmetic Act 


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1 (21 U.S.C. 360fff et seq.) is amended by adding at the 

2 end the following: 

3 ‘‘SEC. 586H. SUNSET. 

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

5 of fiscal year 2022.’’. 

6 (4) TREATMENT OF FINAL SUNSCREEN ORDER.— 

7 The Federal Food, Drug, and Cosmetic Act is amend8 ed by striking section 586E of such Act (21 U.S.C. 

9 360fff–5). 

10 (c) TREATMENT OF NON-SUNSCREEN TIME AND EX11 TENT APPLICATIONS.— 

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

13 section 586F of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 360fff–6) that was submitted to the 

15 Secretary of Health and Human Services pursuant to 

16 section 330.14 of title 21, Code of Federal Regula17 tions, as such provisions were in effect immediately 

18 prior to the date of enactment date of this Act, shall 

19 be extinguished as of such date of enactment, subject 

20 to paragraph (2). 

21 (2) ORDER REQUEST.—Nothing in paragraph 

22 (1) precludes the submission of an order request under 

23 section 505G(b) of the Federal Food, Drug, and Cos24 metic Act, as added by section 101 of this Act, with 


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1 respect to a drug that was the subject of an applica2 tion extinguished under paragraph (1). 

3 SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE 

4 PEDIATRIC INDICATION FOR CERTAIN OTC 

5 COUGH AND COLD DRUGS. 

6 (a) IN GENERAL.—Subject to subsection (c), the Sec7 retary of Health and Human Services shall, beginning not 

8 later than one year after the date of enactment of this Act, 

9 annually submit to the Committee on Energy and Com10 merce of the House of Representatives and the Committee 

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

12 a letter describing the progress of the Food and Drug Ad13 ministration— 

14 (1) in evaluating the cough and cold monograph 

15 described in subsection (b) with respect to children 

16 under age 6; and 

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

18 monograph to address such children through the order 

19 process under section 505G(b) of the Federal Food, 

20 Drug, and Cosmetic Act, as added by section 101 of 

21 this Act. 

22 (b) COUGH AND COLD MONOGRAPH DESCRIBED.—The 

23 cough and cold monograph described in this subsection con24 sists of the conditions under which nonprescription drugs 

25 containing antitussive, expectorant, nasal decongestant, or 


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1 antihistamine active ingredients (or combinations thereof) 

2 are generally recognized as safe and effective, as specified 

3 in part 341 of title 21, Code of Federal Regulations (as 

4 in effect immediately prior to the date of enactment of this 

5 Act), and included in an order deemed to be established 

6 under section 505G(b) of the Federal Food, Drug, and Cos7 metic Act, as added by section 101 of this Act. 

8 (c) DURATION OF AUTHORITY.—The requirement 

9 under subsection (a) shall terminate as of the date of a letter 

10 submitted by the Secretary of Health and Human Services 

11 pursuant to such subsection in which the Secretary indi12 cates that the Food and Drug Administration has completed 

13 its evaluation and revised, in a final order, as applicable, 

14 the cough and cold monograph as described in subsection 

15 (a)(2). 

16 TITLE II—USER FEES 

17 SEC. 201. SHORT TITLE; FINDING. 

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

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

20 (b) FINDING.—The Congress finds that the fees author21 ized by the amendments made in this title will be dedicated 

22 to OTC monograph drug activities, as set forth in the goals 

23 identified for purposes of part 10 of subchapter C of chapter 

24 VII of the Federal Food, Drug, and Cosmetic Act, in the 

25 letters from the Secretary of Health and Human Services 


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1 to the Chairman of the Committee on Health, Education, 

2 Labor, and Pensions of the Senate and the Chairman of 

3 the Committee on Energy and Commerce of the House of 

4 Representatives, as set forth in the Congressional Record. 

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

6 Subchapter C of chapter VII of the Federal Food, 

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

8 by inserting after part 9 the following: 

9 ‘‘PART 10—FEES RELATING TO OVER-THE10 COUNTER DRUGS 

11 ‘‘SEC. 744N. DEFINITIONS. 

12 ‘‘In this part: 

13 ‘‘(1) The term ‘affiliate’ means a business entity 

14 that has a relationship with a second business entity 

15 if, directly or indirectly— 

16 ‘‘(A) one business entity controls, or has the 

17 power to control, the other business entity; or 

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

19 control, both of the business entities. 

20 ‘‘(2) The term ‘contract manufacturing organiza21 tion facility’ means an OTC monograph drug facility 

22 where neither the owner of such manufacturing facil23 ity nor any affiliate of such owner or facility sells the 

24 OTC monograph drug produced at such facility diVerDate Sep 11 2014 22:29 Jul 16, 2018 Jkt 079200 PO 00000 Frm 00062 Fmt 6652 Sfmt 6203 E:\BILLS\H5333.RH H5333

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1 rectly to wholesalers, retailers, or consumers in the 

2 United States. 

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

4 OTC monograph drug activities’ means the expenses 

5 in connection with OTC monograph drug activities 

6 for— 

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

8 Drug Administration, contractors of the Food 

9 and Drug Administration, advisory committees, 

10 and costs related to such officers, employees, and 

11 committees and costs related to contracts with 

12 such contractors; 

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

14 acquisition, maintenance, and repair of com15 puter resources; 

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

17 repair of facilities and acquisition, maintenance, 

18 and repair of fixtures, furniture, scientific equip19 ment, and other necessary materials and sup20 plies; and 

21 ‘‘(D) collecting fees under section 744O and 

22 accounting for resources allocated for OTC mono23 graph drug activities. 

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

25 the unique number automatically generated by Food 


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1 and Drug Administration’s Field Accomplishments 

2 and Compliance Tracking System (FACTS) (or any 

3 successor system). 

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

5 nonprescription drug without an approved new drug 

6 application which is governed by the provisions of 

7 section 505G. 

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

9 means activities of the Secretary associated with OTC 

10 monograph drugs and inspection of facilities associ11 ated with such products, including the following ac12 tivities: 

13 ‘‘(A) The activities necessary for review and 

14 evaluation of OTC monographs and OTC mono15 graph order requests, including— 

16 ‘‘(i) orders proposing or finalizing ap17 plicable conditions of use for OTC mono18 graph drugs; 

19 ‘‘(ii) orders affecting status regarding 

20 general recognition of safety and effective21 ness of an OTC monograph ingredient or 

22 combination of ingredients under specified 

23 conditions of use; 


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1 ‘‘(iii) all OTC monograph drug devel2 opment and review activities, including 

3 intraagency collaboration; 

4 ‘‘(iv) regulation and policy develop5 ment activities related to OTC monograph 

6 drugs; 

7 ‘‘(v) development of product standards 

8 for products subject to review and evalua9 tion; 

10 ‘‘(vi) meetings referred to in section 

11 505G(i); 

12 ‘‘(vii) review of labeling prior to 

13 issuance of orders related to OTC mono14 graph drugs or conditions of use; and 

15 ‘‘(viii) regulatory science activities re16 lated to OTC monograph drugs. 

17 ‘‘(B) Inspections related to OTC monograph 

18 drugs. 

19 ‘‘(C) Monitoring of clinical and other re20 search conducted in connection with OTC mono21 graph drugs. 

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

23 monograph drugs, including— 


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1 ‘‘(i) collecting, developing, and review2 ing safety information on OTC monograph 

3 drugs, including adverse event reports; 

4 ‘‘(ii) developing and using improved 

5 adverse event data-collection systems, in6 cluding information technology systems; 

7 and 

8 ‘‘(iii) developing and using improved 

9 analytical tools to assess potential safety 

10 risks, including access to external databases. 

11 ‘‘(E) Other activities necessary for imple12 mentation of section 505G. 

13 ‘‘(7) The term ‘OTC monograph order request’ 

14 means a request for an order submitted under section 

15 505G(b)(5). 

16 ‘‘(8) The term ‘Tier 1 OTC monograph order re17 quest’ means any OTC monograph order request not 

18 determined to be a Tier 2 OTC monograph order re19 quest. 

20 ‘‘(9)(A) The term ‘Tier 2 OTC monograph order 

21 request’ means, subject to subparagraph (B), an OTC 

22 monograph order request for— 

23 ‘‘(i) the reordering of existing information 

24 in the drug facts label of an OTC monograph 

25 drug; 


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

2 other information section of the drug facts label 

3 of an OTC monograph drug, as limited by sec4 tion 201.66(c)(7) of title 21, Code of Federal 

5 Regulations (or any successor regulations); 

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

7 section of the drug facts label of an OTC mono8 graph drug, if such changes conform to changes 

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

10 ‘‘(iv) the standardization of the concentra11 tion or dose of a specific finalized ingredient 

12 within a particular finalized monograph; 

13 ‘‘(v) a change to ingredient nomenclature to 

14 align with nomenclature of a standards-setting 

15 organization; or 

16 ‘‘(vi) addition of an interchangeable term in 

17 accordance with section 330.1 of title 21, Code of 

18 Federal Regulations (or any successor regula19 tions). 

20 ‘‘(B) The Secretary may, based on program im21 plementation experience or other factors found appro22 priate by the Secretary, characterize any OTC mono23 graph order request as a Tier 2 OTC monograph 

24 order request (including recharacterizing a request 

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1 tion in a proposed order issued pursuant to section 

2 505G. 

3 ‘‘(10)(A) The term ‘OTC monograph drug facil4 ity’ means a foreign or domestic business or other en5 tity that— 

6 ‘‘(i) is— 

7 ‘‘(I) under one management, either di8 rect or indirect; and 

9 ‘‘(II) at one geographic location or ad10 dress engaged in manufacturing or proc11 essing the finished dosage form of an OTC 

12 monograph drug; 

13 ‘‘(ii) includes a finished dosage form manu14 facturer facility in a contractual relationship 

15 with the sponsor of one or more OTC monograph 

16 drugs to manufacture or process such drugs; and 

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

18 entity whose only manufacturing or processing 

19 activities are one or more of the following: pro20 duction of clinical research supplies, or testing. 

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

22 separate buildings or locations within close proximity 

23 are considered to be at one geographic location or ad24 dress if the activities conducted in such buildings or 

25 locations are— 


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1 ‘‘(i) closely related to the same business en2 terprise; 

3 ‘‘(ii) under the supervision of the same local 

4 management; and 

5 ‘‘(iii) under a single FDA establishment 

6 identifier and capable of being inspected by the 

7 Food and Drug Administration during a single 

8 inspection. 

9 ‘‘(C) If a business or other entity would meet cri10 teria specified in subparagraph (A), but for being 

11 under multiple management, the business or other en12 tity is deemed to constitute multiple facilities, one per 

13 management entity, for purposes of this paragraph. 

14 ‘‘(11) The term ‘OTC monograph drug meeting’ 

15 means any meeting regarding the content of a pro16 posed OTC monograph order request. 

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

18 a person. 

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

20 the meanings given such terms in section 505G. 

21 ‘‘SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONO22 GRAPH FEES. 

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

24 2019, the Secretary shall assess and collect fees in accord25 ance with this section as follows: 


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1 ‘‘(1) FACILITY FEE.— 

2 ‘‘(A) IN GENERAL.—Each person that owns 

3 a facility identified as an OTC monograph drug 

4 facility on December 31 of the fiscal year or at 

5 any time during the preceding 12-month period 

6 shall be assessed an annual fee for each such fa7 cility as determined under subsection (c). 

8 ‘‘(B) EXCEPTIONS.— 

9 ‘‘(i) A fee shall not be assessed under 

10 subparagraph (A) if the identified OTC 

11 monograph drug facility has ceased all ac12 tivities related to OTC monograph drugs 

13 prior to the date specified in subparagraph 

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

15 reflect such change under the requirements 

16 for drug establishment registration set forth 

17 in section 510. 

18 ‘‘(ii) The amount of the fee for a con19 tract manufacturing organization facility 

shall be equal to 2 20 ⁄3 the amount of the fee for 

21 an OTC monograph drug facility that is 

22 not a contract manufacturing organization 

23 facility. 


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1 ‘‘(C) AMOUNT.—The amount of fees estab2 lished under subparagraph (A) shall be estab3 lished under subsection (c). 

4 ‘‘(D) DUE DATE.— 

5 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

6 fiscal year 2019, the facility fees required 

7 under subparagraph (A) shall be due 45 cal8 endar days after publication of the Federal 

9 Register notice provided for under sub10 section (c)(4)(A). 

11 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

12 For each fiscal year after fiscal year 2019, 

13 the facility fees required under subpara14 graph (A) shall be due on the later of— 

15 ‘‘(I) the first business day of June 

16 of such year; or 

17 ‘‘(II) the first business day after 

18 the enactment of an appropriations 

19 Act providing for the collection and ob20 ligation of fees under this section for 

21 such year. 

22 ‘‘(2) OTC MONOGRAPH ORDER REQUEST FEE.— 

23 ‘‘(A) IN GENERAL.—Each person that sub24 mits an OTC monograph order request shall be 


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1 subject to a fee for an OTC monograph order re2 quest. The amount of such fee shall be— 

3 ‘‘(i) for a Tier 1 OTC monograph 

4 order request, $500,000, adjusted for infla5 tion for the fiscal year (as determined under 

6 subsection (c)(1)(B)); and 

7 ‘‘(ii) for a Tier 2 OTC monograph 

8 order request, $100,000 adjusted for infla9 tion for the fiscal year (as determined under 

10 subsection (c)(1)(B)). 

11 ‘‘(B) DUE DATE.—The OTC monograph 

12 order request fees required under subparagraph 

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

14 OTC monograph order request. 

15 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

16 CHANGES.—A person who is named as the re17 questor in an OTC monograph order shall not be 

18 subject to a fee under subparagraph (A) if the 

19 Secretary finds that the OTC monograph order 

20 request seeks to change the drug facts labeling of 

21 an OTC monograph drug in a way that would 

22 add to or strengthen— 

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

24 precaution; 


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1 ‘‘(ii) a statement about risk associated 

2 with misuse or abuse; or 

3 ‘‘(iii) an instruction about dosage and 

4 administration that is intended to increase 

5 the safe use of the OTC monograph drug. 

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

7 IS RECATEGORIZED AS A TIER 2 OTC MONO8 GRAPH ORDER REQUEST.—If the Secretary deter9 mines that an OTC monograph request initially 

10 characterized as Tier 1 shall be re-characterized 

11 as a Tier 2 OTC monograph order request, and 

12 the requestor has paid a Tier 1 fee in accordance 

13 with subparagraph (A)(i), the Secretary shall re14 fund the requestor the difference between the Tier 

15 1 and Tier 2 fees determined under subpara16 graphs (A)(i) and (A)(ii), respectively. 

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

18 REFUSED FOR FILING OR WITHDRAWN BEFORE

19 FILING.—The Secretary shall refund 75 percent 

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

21 order request which is refused for filing or was 

22 withdrawn before being accepted or refused for 

23 filing. 

24 ‘‘(F) FEES FOR ORDER REQUESTS PRE25 VIOUSLY REFUSED FOR FILING OR WITHDRAWN


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1 BEFORE FILING.—An OTC monograph order re2 quest that was submitted but was refused for fil3 ing, or was withdrawn before being accepted or 

4 refused for filing, shall be subject to the full fee 

5 under subparagraph (A) upon being resubmitted 

6 or filed over protest. 

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

8 WITHDRAWN.—If an order request is withdrawn 

9 after the order request was filed, the Secretary 

10 may refund the fee or a portion of the fee if no 

11 substantial work was performed on the order re12 quest after the application was filed. The Sec13 retary shall have the sole discretion to refund a 

14 fee or a portion of the fee under this subpara15 graph. A determination by the Secretary con16 cerning a refund under this subparagraph shall 

17 not be reviewable. 

18 ‘‘(3) REFUNDS.— 

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

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

21 paragraph (2), the Secretary shall not refund 

22 any fee paid under paragraph (1) except as pro23 vided in subparagraph (B). 

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

25 qualify for the return of a fee claimed to have 


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

2 a person shall submit to the Secretary a written 

3 request justifying such return within 180 cal4 endar days after such fee was paid. 

5 ‘‘(4) NOTICE.—Within the timeframe specified in 

6 subsection (c), the Secretary shall publish in the Fed7 eral Register the amount of the fees under paragraph 

8 (1) for such fiscal year. 

9 ‘‘(b) FEE REVENUE AMOUNTS.— 

10 ‘‘(1) FISCAL YEAR 2019.—For fiscal year 2019, 

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

12 generate a total facility fee revenue amount equal to 

13 the sum of— 

14 ‘‘(A) the annual base revenue for fiscal year 

15 2019 (as determined under paragraph (3); 

16 ‘‘(B) the dollar amount equal to the oper17 ating reserve adjustment for the fiscal year, if 

18 applicable (as determined under subsection 

19 (c)(2)); and 

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

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

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

23 the fiscal years 2020 through 2023, fees under sub24 section (a)(1) shall be established to generate a total 

25 facility fee revenue amount equal to the sum of— 


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

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

3 ‘‘(B) the dollar amount equal to the infla4 tion adjustment for the fiscal year (as deter5 mined under subsection (c)(1)); 

6 ‘‘(C) the dollar amount equal to the oper7 ating reserve adjustment for the fiscal year, if 

8 applicable (as determined under subsection 

9 (c)(2)); 

10 ‘‘(D) additional direct cost adjustments (as 

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

12 ‘‘(E) additional dollar amounts for each fis13 cal year as follows: 

14 ‘‘(i) $7,000,000 for fiscal year 2020. 

15 ‘‘(ii) $6,000,000 for fiscal year 2021. 

16 ‘‘(iii) $7,000,000 for fiscal year 2022. 

17 ‘‘(iv) $3,000,000 for fiscal year 2023. 

18 ‘‘(3) ANNUAL BASE REVENUE.—For purposes of 

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

20 the annual base revenue for a fiscal year shall be— 

21 ‘‘(A) for fiscal year 2019, $8,000,000; and 

22 ‘‘(B) for fiscal years 2020 through 2023, the 

23 dollar amount of the total revenue amount estab24 lished under this subsection for the previous fisVerDate Sep 11 2014 22:29 Jul 16, 2018 Jkt 079200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6203 E:\BILLS\H5333.RH H5333

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1 cal year, not including any adjustments made 

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

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

4 ‘‘(1) INFLATION ADJUSTMENT.— 

5 ‘‘(A) IN GENERAL.—For purposes of sub6 section (b)(2)(B), the dollar amount of the infla7 tion adjustment to the annual base revenue for 

8 fiscal year 2020 and each subsequent fiscal year 

9 shall be equal to the product of— 

10 ‘‘(i) such annual base revenue for the 

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

12 ‘‘(ii) the inflation adjustment percent13 age under subparagraph (C). 

14 ‘‘(B) OTC MONOGRAPH ORDER REQUEST

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

16 dollar amount of the inflation adjustment to the 

17 fee for OTC monograph order requests for fiscal 

18 year 2020 and each subsequent fiscal year shall 

19 be equal to the product of— 

20 ‘‘(i) the applicable fee under subsection 

21 (a)(2) for the preceding fiscal year; and 

22 ‘‘(ii) the inflation adjustment percent23 age under subparagraph (C). 

24 ‘‘(C) INFLATION ADJUSTMENT PERCENT25 AGE.—The inflation adjustment percentage 


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1 under this subparagraph for a fiscal year is 

2 equal to— 

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

4 2021, the average annual percent change 

5 that occurred in the Consumer Price Index 

6 for urban consumers (Washington-Balti7 more, DC–MD–VA–WV; Not Seasonally Ad8 justed; All items; Annual Index) for the first 

9 3 years of the preceding 4 years of available 

10 data; and 

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

12 2023, the sum of— 

13 ‘‘(I) the average annual percent 

14 change in the cost, per full-time equiv15 alent position of the Food and Drug 

16 Administration, of all personnel com17 pensation and benefits paid with re18 spect to such positions for the first 3 

19 years of the preceding 4 fiscal years, 

20 multiplied by the proportion of per21 sonnel compensation and benefits costs 

22 to total costs of OTC monograph drug 

23 activities for the first 3 years of the 

24 preceding 4 fiscal years; and 


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1 ‘‘(II) the average annual percent 

2 change that occurred in the Consumer 

3 Price Index for urban consumers 

4 (Washington-Baltimore, DC–MD–VA– 

5 WV; Not Seasonally Adjusted; All 

6 items; Annual Index) for the first 3 

7 years of the preceding 4 years of avail8 able data multiplied by the proportion 

9 of all costs other than personnel com10 pensation and benefits costs to total 

11 costs of OTC monograph drug activi12 ties for the first 3 years of the pre13 ceding 4 fiscal years. 

14 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

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

16 and subsequent fiscal years, for purposes of sub17 sections (b)(1)(B) and (b)(2)(C), the Secretary 

18 may, in addition to adjustments under para19 graph (1), further increase the fee revenue and 

20 fees if such an adjustment is necessary to provide 

21 operating reserves of carryover user fees for OTC 

22 monograph drug activities for not more than the 

23 number of weeks specified in subparagraph (B). 

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

25 weeks specified in this subparagraph is— 


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

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

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

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

5 and 

6 ‘‘(v) 10 weeks for fiscal year 2023. 

7 ‘‘(C) DECREASE.—If the Secretary has car8 ryover balances for such process in excess of 10 

9 weeks of the operating reserves referred to in sub10 paragraph (A), the Secretary shall decrease the 

11 fee revenue and fees referred to in such subpara12 graph to provide for not more than 10 weeks of 

13 such operating reserves. 

14 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If an 

15 adjustment under this paragraph is made, the 

16 rationale for the amount of the increase or de17 crease (as applicable) in fee revenue and fees 

18 shall be contained in the annual Federal Reg19 ister notice under paragraph (4) establishing fee 

20 revenue and fees for the fiscal year involved. 

21 ‘‘(3) ADDITIONAL DIRECT COST ADJUSTMENT.— 

22 The Secretary shall, in addition to adjustments under 

23 paragraphs (1) and (2), further increase the fee rev24 enue and fees for purposes of subsection (b)(2)(D) by 

25 an amount equal to— 


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1 ‘‘(A) $14,000,000 for fiscal year 2019; 

2 ‘‘(B) $7,000,000 for fiscal year 2020; 

3 ‘‘(C) $4,000,000 for fiscal year 2021; 

4 ‘‘(D) $3,000,000 for fiscal year 2022; and 

5 ‘‘(E) $3,000,000 for fiscal year 2023. 

6 ‘‘(4) ANNUAL FEE SETTING.— 

7 ‘‘(A) FISCAL YEAR 2019.—The Secretary 

8 shall, not later than January 31, 2019— 

9 ‘‘(i) establish OTC monograph drug fa10 cility fees for fiscal year 2019 under sub11 section (a), based on the revenue amount for 

12 such year under subsection (b) and the ad13 justments provided under this subsection; 

14 and 

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

16 and OTC monograph order requests in the 

17 Federal Register. 

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

19 Secretary shall, not later than January 31 of 

20 each fiscal year that begins after September 30, 

21 2019, establish for each such fiscal year, based on 

22 the revenue amounts under subsection (b) and 

23 the adjustments provided under this subsection— 

24 ‘‘(i) OTC monograph drug facility fees 

25 under subsection (a)(1); 


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1 ‘‘(ii) OTC monograph order request 

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

3 ‘‘(iii) publish such fee revenue 

4 amounts, facility fees, and OTC monograph 

5 order request fees in the Federal Register. 

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

7 that owns an OTC monograph drug facility shall submit 

8 to the Secretary the information required under this sub9 section each year. Such information shall, for each fiscal 

10 year— 

11 ‘‘(1) be submitted as part of the requirements for 

12 drug establishment registration set forth in section 

13 510; and 

14 ‘‘(2) include for each such facility, at a min15 imum, identification of the facility’s business oper16 ation as that of an OTC monograph drug facility. 

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

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

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

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

21 of the due date as specified in subparagraph (D) 

22 of such subsection shall result in the following: 

23 ‘‘(i) The Secretary shall place the facil24 ity on a publicly available arrears list. 


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1 ‘‘(ii) All OTC monograph drugs manu2 factured in such a facility or containing an 

3 ingredient manufactured in such a facility 

4 shall be deemed misbranded under section 

5 502(a). 

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

7 penalties under this paragraph shall apply until 

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

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

10 order request submitted by a person subject to fees 

11 under subsection (a) shall be considered incomplete 

12 and shall not be accepted for filing by the Secretary 

13 until all fees owed by such person under this section 

14 have been paid. 

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

16 this section shall be considered ineligible for OTC 

17 monograph drug meetings until all such fees owed by 

18 such person have been paid. 

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

20 ‘‘(1) IN GENERAL.—Fees authorized under sub21 section (a) shall be collected and available for obliga22 tion only to the extent and in the amount provided 

23 in advance in appropriations Acts. Such fees are au24 thorized to remain available until expended. Such 

25 sums as may be necessary may be transferred from 


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1 the Food and Drug Administration salaries and ex2 penses appropriation account without fiscal year lim3 itation to such appropriation account for salaries and 

4 expenses with such fiscal year limitation. The sums 

5 transferred shall be available solely for OTC mono6 graph drug activities. 

7 ‘‘(2) COLLECTIONS AND APPROPRIATION ACTS.— 

8 ‘‘(A) IN GENERAL.—Subject to subpara9 graph (C), the fees authorized by this section 

10 shall be collected and available in each fiscal 

11 year in an amount not to exceed the amount 

12 specified in appropriation Acts, or otherwise 

13 made available for obligation, for such fiscal 

14 year. 

15 ‘‘(B) USE OF FEES AND LIMITATION.—The 

16 fees authorized by this section shall be available 

17 to defray increases in the costs of the resources 

18 allocated for OTC monograph drug activities 

19 (including increases in such costs for an addi20 tional number of full-time equivalent positions 

21 in the Department of Health and Human Serv22 ices to be engaged in such activities), only if the 

23 Secretary allocates for such purpose an amount 

24 for such fiscal year (excluding amounts from fees 

25 collected under this section) no less than 


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1 $12,000,000, multiplied by the adjustment factor 

2 applicable to the fiscal year involved under sub3 section (c)(1). 

4 ‘‘(C) COMPLIANCE.—The Secretary shall be 

5 considered to have met the requirements of sub6 paragraph (B) in any fiscal year if the costs 

7 funded by appropriations and allocated for OTC 

8 monograph drug activities are not more than 15 

9 percent below the level specified in such subpara10 graph. 

11 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

12 SUBSEQUENT YEARS.—Payment of fees author13 ized under this section for a fiscal year (after fis14 cal year 2019), prior to the due date for such 

15 fees, may be accepted by the Secretary in accord16 ance with authority provided in advance in a 

17 prior year appropriations Act. 

18 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

19 each of the fiscal years 2019 through 2023, there is 

20 authorized to be appropriated for fees under this sec21 tion an amount equal to the total amount of fees as22 sessed for such fiscal year under this section. 

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

24 where the Secretary does not receive payment of a fee as25 sessed under subsection (a) within 30 calendar days after 


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1 it is due, such fee shall be treated as a claim of the United 

2 States Government subject to subchapter II of chapter 37 

3 of title 31, United States Code. 

4 ‘‘(h) CONSTRUCTION.—This section may not be con5 strued to require that the number of full-time equivalent 

6 positions in the Department of Health and Human Serv7 ices, for officers, employers, and advisory committees not 

8 engaged in OTC monograph drug activities, be reduced to 

9 offset the number of officers, employees, and advisory com10 mittees so engaged. 

11 ‘‘SEC. 744P. REAUTHORIZATION; REPORTING REQUIRE12 MENTS. 

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

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

15 end of each fiscal year thereafter for which fees are collected 

16 under this part, the Secretary shall prepare and submit to 

17 the Committee on Energy and Commerce of the House of 

18 Representatives and the Committee on Health, Education, 

19 Labor, and Pensions of the Senate a report concerning the 

20 progress of the Food and Drug Administration in achieving 

21 the goals identified in the letters described in section 201(b) 

22 of the Over-the-Counter Monograph Safety, Innovation, and 

23 Reform Act of 2018 during such fiscal year and the future 

24 plans of the Food and Drug Administration for meeting 

25 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, the 

4 Secretary shall prepare and submit to the Committee on 

5 Energy and Commerce of the House of Representatives and 

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

7 of the Senate a report on the implementation of the author8 ity for such fees during such fiscal year and the use, by 

9 the Food and Drug Administration, of the fees collected for 

10 such fiscal year. 

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

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

13 to the public on the Internet website of the Food and Drug 

14 Administration. 

15 ‘‘(d) REAUTHORIZATION.— 

16 ‘‘(1) CONSULTATION.—In developing rec17 ommendations to present to the Congress with respect 

18 to the goals described in subsection (a), and plans for 

19 meeting the goals, for OTC monograph drug activities 

20 for the first 5 fiscal years after fiscal year 2023, and 

21 for the reauthorization of this part for such fiscal 

22 years, the Secretary shall consult with— 

23 ‘‘(A) the Committee on Energy and Com24 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 RECOMMENDATIONS.— 

9 After negotiations with the regulated industry, the 

10 Secretary shall— 

11 ‘‘(A) present the recommendations developed 

12 under paragraph (1) to the congressional com13 mittees 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 recommendations; 

21 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.—Not 

2 later than January 15, 2023, the Secretary shall 

3 transmit to the Congress the revised recommendations 

4 under paragraph (2), a summary of the views and 

5 comments received under such paragraph, and any 

6 changes made to the recommendations in response to 

7 such views and comments.’’. 


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Union Calendar No. 640 

115TH CONGRESS 

2D SESSION H. R. 5333 

[Report No. 115–827] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

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 reJULY 16, 2018 

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


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