II 

Calendar No. 518 

115TH CONGRESS 

2D SESSION H. R. 5333 

IN THE SENATE OF THE UNITED STATES 

JULY 17, 2018 

Received; read twice and placed on the calendar 

AN ACT 

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

clarify the regulatory framework with respect to certain 

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

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

3 SECTION 1. SHORT TITLE. 

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

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


dlhill on DSK3GLQ082PROD with BILLS
2 

HR 5333 PCS

1 TITLE I—OTC DRUG REVIEW 

2 SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 

3 DRUGS THAT ARE MARKETED WITHOUT AN 

4 APPROVED NEW DRUG APPLICATION. 

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

6 Drug, and Cosmetic Act is amended by inserting after sec7 tion 505F of such Act (21 U.S.C. 355g) the following: 

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

9 DRUGS THAT ARE MARKETED WITHOUT AN 

10 APPROVED NEW DRUG APPLICATION. 

11 ‘‘(a) NONPRESCRIPTION DRUGS MARKETED WITH12 OUT AN APPROVED APPLICATION.—Nonprescription 

13 drugs marketed without an approved new drug application 

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

15 Over-the-Counter Monograph Safety, Innovation, and Re16 form Act of 2018, shall be treated in accordance with this 

17 subsection. 

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

19 CATEGORY I DRUGS SUBJECT TO A TENTATIVE

20 FINAL MONOGRAPH.—A drug is deemed to be gen21 erally recognized as safe and effective within the 

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

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

24 if— 

25 ‘‘(A) the drug is— 


dlhill on DSK3GLQ082PROD with BILLS
3 

HR 5333 PCS

1 ‘‘(i) in conformity with the require2 ments for nonprescription use of a final 

3 monograph issued under part 330 of title 

4 21, Code of Federal Regulations (except as 

5 provided in paragraph (2)), the general re6 quirements for nonprescription drugs, and 

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

8 and (k); and 

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

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

11 of a minor change in the drug, in con12 formity with an order issued under sub13 section (c), in a dosage form that, imme14 diately prior to the date of the enactment 

15 of this section, has been used to a material 

16 extent and for a material time within the 

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

18 ‘‘(B) the drug is— 

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

20 and effectiveness under a tentative final 

21 monograph that is the most recently appli22 cable proposal or determination issued 

23 under part 330 of title 21, Code of Federal 

24 Regulations; 


dlhill on DSK3GLQ082PROD with BILLS
4 

HR 5333 PCS

1 ‘‘(ii) in conformity with the proposed 

2 requirements for nonprescription use of 

3 such tentative final monograph, any appli4 cable subsequent determination by the Sec5 retary, the general requirements for non6 prescription drugs, and requirements under 

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

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

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

10 of a minor change in the drug, in con11 formity with an order issued under sub12 section (c), in a dosage form that, imme13 diately prior to the date of the enactment 

14 of this section, has been used to a material 

15 extent and for a material time within the 

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

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

18 With respect to sunscreen drugs subject to this sec19 tion, the applicable requirements shall be the re20 quirements specified in part 352 of title 21, Code of 

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

22 beginning on page 27687 of volume 64 of the Fed23 eral Register, except that the applicable require24 ments governing effectiveness and labeling shall be 

25 those specified in section 201.327 of title 21, Code 


dlhill on DSK3GLQ082PROD with BILLS
5 

HR 5333 PCS

1 of Federal Regulations, subject to the requirements 

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

3 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN4 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS

5 SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE

6 NOTICE OF PROPOSED RULEMAKING.—A drug that 

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

8 required to be the subject of an application approved 

9 under section 505, and is not subject to section 

10 503(b)(1), if— 

11 ‘‘(A) the drug is— 

12 ‘‘(i) classified in category III for safe13 ty or effectiveness in the preamble of a 

14 proposed rule establishing a tentative final 

15 monograph that is the most recently appli16 cable proposal or determination for such 

17 drug issued under part 330 of title 21, 

18 Code of Federal Regulations; 

19 ‘‘(ii) in conformity with— 

20 ‘‘(I) the conditions of use, includ21 ing indication and dosage strength, if 

22 any, described for such category III 

23 drug in such preamble or in an appli24 cable subsequent proposed rule; 


dlhill on DSK3GLQ082PROD with BILLS
6 

HR 5333 PCS

1 ‘‘(II) the proposed requirements 

2 for drugs classified in such tentative 

3 final monograph in category I in the 

4 most recently proposed rule estab5 lishing requirements related to such 

6 tentative final monograph and in any 

7 final rule establishing requirements 

8 that are applicable to the drug; and 

9 ‘‘(III) the general requirements 

10 for nonprescription drugs and require11 ments under subsections (b) or (k); 

12 and 

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

15 of this section, was not required to have 

16 satisfied the requirements of section 

17 330.14 of title 21, Code of Federal Regula18 tions (as in effect at that time), in order 

19 for such drug to be lawfully marketed 

20 without an application approved under sec21 tion 505; or 

22 ‘‘(B) the drug is— 

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

24 and effectiveness under a proposed mono25 graph or advance notice of proposed ruleVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
7 

HR 5333 PCS

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 

15 of this section, has been used to a material 

16 extent 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 

25 deemed to be a new drug within the meaning of secVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
8 

HR 5333 PCS

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

2 subject to the requirement for an approved new drug 

3 application under section 505 beginning on the day 

4 that is 180 calendar days after the date of the en5 actment of this section, unless, before such day, the 

6 Secretary determines that it is in the interest of 

7 public health to extend the period during which the 

8 drug may be marketed without such an approved 

9 new drug application. 

10 ‘‘(5) DRUGS NOT GRASE DEEMED NEW

11 DRUGS.—A drug that the Secretary has determined 

12 not to be generally recognized as safe and effective 

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

14 final determination issued under part 330 of title 

15 21, Code of Federal Regulations, shall be deemed to 

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

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

18 the requirement for an approved new drug applica19 tion under section 505. 

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

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

22 deemed to be a new drug within the meaning of sec23 tion 201(p) and misbranded under section 502(ee) if 

24 the drug— 


dlhill on DSK3GLQ082PROD with BILLS
9 

HR 5333 PCS

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

2 and 

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

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

5 ‘‘(b) ADMINISTRATIVE ORDERS.— 

6 ‘‘(1) IN GENERAL.— 

7 ‘‘(A) DETERMINATION.—The Secretary 

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

9 request of one or more requestors, issue admin10 istrative orders determining whether there are 

11 conditions under which specific drugs, classes of 

12 such drugs, or combinations of such drugs are 

13 determined to be— 

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

15 and 

16 ‘‘(ii) generally recognized as safe and 

17 effective within the meaning of section 

18 201(p)(1). 

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

20 drugs shall be deemed to not require approval 

21 under section 505 if such drug or combination 

22 of drugs— 

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

24 meet the conditions specified in clauses (i) 

25 and (ii) of subparagraph (A); 


dlhill on DSK3GLQ082PROD with BILLS
10 

HR 5333 PCS

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 

13 is not generally recognized as safe and ef14 fective within the meaning of section 

15 201(p)(1); or 

16 ‘‘(ii) the evidence is inadequate to 

17 show that the drug is generally recognized 

18 as safe and effective within the meaning of 

19 section 201(p)(1). 

20 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY

21 THE SECRETARY.— 

22 ‘‘(A) IN GENERAL.—In issuing an adminis23 trative order under paragraph (1) upon the 

24 Secretary’s initiative, the Secretary shall— 


dlhill on DSK3GLQ082PROD with BILLS
11 

HR 5333 PCS

1 ‘‘(i) make reasonable efforts to notify 

2 informally, not later than 2 business days 

3 before the issuance of the proposed order, 

4 the sponsors of drugs who have a listing in 

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

6 combination of drugs that will be subject 

7 to the administrative order; 

8 ‘‘(ii) after any such reasonable efforts 

9 of notification— 

10 ‘‘(I) issue a proposed administra11 tive order by publishing it on the 

12 website of the Food and Drug Admin13 istration and include in such order the 

14 reasons for the issuance of such order; 

15 and 

16 ‘‘(II) publish a notice of avail17 ability of such proposed order in the 

18 Federal Register; 

19 ‘‘(iii) except as provided in subpara20 graph (B), provide for a public comment 

21 period with respect to such proposed order 

22 of not less than 45 calendar days; and 

23 ‘‘(iv) if, after completion of the pro24 ceedings specified in clauses (i) through 

25 (iii), the Secretary determines that it is apVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
12 

HR 5333 PCS

1 propriate to issue a final administrative 

2 order— 

3 ‘‘(I) issue the final administrative 

4 order, together with a detailed state5 ment of reasons, which order shall not 

6 take effect until the time for request7 ing judicial review under paragraph 

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

9 ‘‘(II) publish a notice of such 

10 final administrative order in the Fed11 eral Register; 

12 ‘‘(III) afford requestors of drugs 

13 that will be subject to such order the 

14 opportunity for formal dispute resolu15 tion up to the level of the Director of 

16 the Center for Drug Evaluation and 

17 Research, which initially must be re18 quested within 45 calendar days of 

19 the issuance of the order, and, for 

20 subsequent levels of appeal, within 30 

21 calendar days of the prior decision; 

22 and 

23 ‘‘(IV) except with respect to 

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

25 upon completion of the formal dispute 


dlhill on DSK3GLQ082PROD with BILLS
13 

HR 5333 PCS

1 resolution procedure, inform the per2 sons which sought such dispute reso3 lution of their right to request a hear4 ing. 

5 ‘‘(B) EXCEPTIONS.—When issuing an ad6 ministrative order under paragraph (1) on the 

7 Secretary’s initiative proposing to determine 

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

9 generally recognized as safe and effective within 

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

11 shall follow the procedures in subparagraph 

12 (A), except that— 

13 ‘‘(i) the proposed order shall include 

14 notice of— 

15 ‘‘(I) the general categories of 

16 data the Secretary has determined 

17 necessary to establish that the drug is 

18 generally recognized as safe and effec19 tive within the meaning of section 

20 201(p)(1); and 

21 ‘‘(II) the format for submissions 

22 by interested persons; 

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

24 public comment period of no less than 180 

25 calendar days with respect to such proVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
14 

HR 5333 PCS

1 posed order, except when the Secretary de2 termines, for good cause, that a shorter pe3 riod is in the interests of public health; 

4 and 

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

6 such comment period shall include a cer7 tification that the person has submitted all 

8 evidence created, obtained, or received by 

9 that person that is both within the cat10 egories of data identified in the proposed 

11 order and relevant to a determination as to 

12 whether the drug is generally recognized as 

13 safe and effective within the meaning of 

14 section 201(p)(1). 

15 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

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

17 participated in each stage of formal dispute res18 olution under subclause (III) of paragraph 

19 (2)(A)(iv) of an administrative order with re20 spect to a drug may request a hearing con21 cerning a final administrative order issued 

22 under such paragraph with respect to such 

23 drug. Such person must submit a request for a 

24 hearing, which shall be based solely on informa25 tion in the administrative record, to the SecVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
15 

HR 5333 PCS

1 retary not later than 30 calendar days after re2 ceiving notice of the final decision of the formal 

3 dispute resolution procedure. 

4 ‘‘(B) NO HEARING REQUIRED WITH RE5 SPECT TO ORDERS RELATING TO CERTAIN

6 DRUGS.— 

7 ‘‘(i) IN GENERAL.—The Secretary 

8 shall not be required to provide notice and 

9 an opportunity for a hearing pursuant to 

10 paragraph (2)(A)(iv) if the final adminis11 trative order involved relates to a drug— 

12 ‘‘(I) that is described in sub13 section (a)(3)(A); and 

14 ‘‘(II) with respect to which no 

15 human or non-human data studies rel16 evant to the safety or effectiveness of 

17 such drug have been submitted to the 

18 administrative record since the 

19 issuance of the most recent tentative 

20 final monograph relating to such 

21 drug. 

22 ‘‘(ii) HUMAN DATA STUDIES AND

23 NON-HUMAN DATA DEFINED.—In this sub24 paragraph: 


dlhill on DSK3GLQ082PROD with BILLS
16 

HR 5333 PCS

1 ‘‘(I) The term ‘human data stud2 ies’ means clinical trials of safety or 

3 effectiveness (including actual use 

4 studies), pharmacokinetics studies, or 

5 bioavailability studies. 

6 ‘‘(II) The term ‘non-human data’ 

7 means data from testing other than 

8 with human subjects which provides 

9 information concerning safety or ef10 fectiveness. 

11 ‘‘(C) HEARING PROCEDURES.— 

12 ‘‘(i) DENIAL OF REQUEST FOR HEAR13 ING.—If the Secretary determines that in14 formation submitted in a request for a 

15 hearing under subparagraph (A) with re16 spect to a final administrative order issued 

17 under paragraph (2)(A)(iv), does not iden18 tify the existence of a genuine and sub19 stantial question of material fact, the Sec20 retary may deny such request. In making 

21 such a determination, the Secretary may 

22 consider only information and data that 

23 are based on relevant and reliable scientific 

24 principles and methodologies. 


dlhill on DSK3GLQ082PROD with BILLS
17 

HR 5333 PCS

1 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

2 RELATED REQUESTS.—If more than one 

3 request for a hearing is submitted with re4 spect to the same administrative order 

5 under subparagraph (A), the Secretary 

6 may direct that a single hearing be con7 ducted in which all persons whose hearing 

8 requests were granted may participate. 

9 ‘‘(iii) PRESIDING OFFICER.—The pre10 siding officer of a hearing requested under 

11 subparagraph (A) shall— 

12 ‘‘(I) be designated by the Sec13 retary; 

14 ‘‘(II) not be an employee of the 

15 Center for Drug Evaluation and Re16 search; and 

17 ‘‘(III) not have been previously 

18 involved in the development of the ad19 ministrative order involved or pro20 ceedings relating to that administra21 tive order. 

22 ‘‘(iv) RIGHTS OF PARTIES TO HEAR23 ING.—The parties to a hearing requested 

24 under subparagraph (A) shall have the 

25 right to present testimony, including testiVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
18 

HR 5333 PCS

1 mony of expert witnesses, and to cross-ex2 amine witnesses presented by other parties. 

3 Where appropriate, the presiding officer 

4 may require that cross-examination by par5 ties representing substantially the same in6 terests be consolidated to promote effi7 ciency and avoid duplication. 

8 ‘‘(v) FINAL DECISION.— 

9 ‘‘(I) At the conclusion of a hear10 ing requested under subparagraph 

11 (A), the presiding officer of the hear12 ing shall issue a decision containing 

13 findings of fact and conclusions of 

14 law. The decision of the presiding offi15 cer shall be final. 

16 ‘‘(II) The final decision may not 

17 take effect until the period under sub18 paragraph (D)(ii) for submitting a re19 quest for judicial review of such deci20 sion expires. 

21 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN22 ISTRATIVE ORDER.— 

23 ‘‘(i) IN GENERAL.—The procedures 

24 described in section 505(h) shall apply 

25 with respect to judicial review of final adVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
19 

HR 5333 PCS

1 ministrative orders issued under this sub2 section in the same manner and to the 

3 same extent as such section applies to an 

4 order described in such section except that 

5 the judicial review shall be taken by filing 

6 in an appropriate district court of the 

7 United States in lieu of the appellate 

8 courts specified in such section. 

9 ‘‘(ii) PERIOD TO SUBMIT A REQUEST

10 FOR JUDICIAL REVIEW.—A person eligible 

11 to request a hearing under this paragraph 

12 and seeking judicial review of a final ad13 ministrative order issued under this sub14 section shall file such request for judicial 

15 review not later than 60 calendar days 

16 after the latest of— 

17 ‘‘(I) the date on which notice of 

18 such order is published; 

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

20 with respect to such order is denied 

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

22 ‘‘(III) the date on which a final 

23 decision is made following a hearing 

24 under subparagraph (C)(v); or 


dlhill on DSK3GLQ082PROD with BILLS
20 

HR 5333 PCS

1 ‘‘(IV) if no hearing is requested, 

2 the date on which the time for re3 questing a hearing expires. 

4 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT

5 TO ADMINISTRATIVE ORDERS INITIATED BY THE

6 SECRETARY.— 

7 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

8 HEALTH.— 

9 ‘‘(i) IN GENERAL.—In the case of a 

10 determination by the Secretary that a 

11 drug, class of drugs, or combination of 

12 drugs subject to this section poses an im13 minent hazard to the public health, the 

14 Secretary, after first making reasonable ef15 forts to notify, not later than 48 hours be16 fore issuance of such order under this sub17 paragraph, sponsors who have a listing in 

18 effect under section 510(j) for such drug 

19 or combination of drugs— 

20 ‘‘(I) may issue an interim final 

21 administrative order for such drug, 

22 class of drugs, or combination of 

23 drugs under paragraph (1), together 

24 with a detailed statement of the rea25 sons for such order; 


dlhill on DSK3GLQ082PROD with BILLS
21 

HR 5333 PCS

1 ‘‘(II) shall publish in the Federal 

2 Register a notice of availability of any 

3 such order; and 

4 ‘‘(III) shall provide for a public 

5 comment period of at least 45 cal6 endar days with respect to such in7 terim final order. 

8 ‘‘(ii) NONDELEGATION.—The Sec9 retary may not delegate the authority to 

10 issue an interim final administrative order 

11 under this subparagraph. 

12 ‘‘(B) SAFETY LABELING CHANGES.— 

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

14 determination by the Secretary that a 

15 change in the labeling of a drug, class of 

16 drugs, or combination of drugs subject to 

17 this section is reasonably expected to miti18 gate a significant or unreasonable risk of 

19 a serious adverse event associated with use 

20 of the drug, the Secretary may— 

21 ‘‘(I) make reasonable efforts to 

22 notify informally, not later than 48 

23 hours before the issuance of the in24 terim final order, the sponsors of 

25 drugs who have a listing in effect 


dlhill on DSK3GLQ082PROD with BILLS
22 

HR 5333 PCS

1 under section 510(j) for such drug or 

2 combination of drugs; 

3 ‘‘(II) after reasonable efforts of 

4 notification, issue an interim final ad5 ministrative order in accordance with 

6 paragraph (1) to require such change, 

7 together with a detailed statement of 

8 the reasons for such order; 

9 ‘‘(III) publish in the Federal 

10 Register a notice of availability of 

11 such order; and 

12 ‘‘(IV) provide for a public com13 ment period of at least 45 calendar 

14 days with respect to such interim final 

15 order. 

16 ‘‘(ii) CONTENT OF ORDER.—An in17 terim final order issued under this sub18 paragraph with respect to the labeling of a 

19 drug may provide for new warnings and 

20 other information required for safe use of 

21 the drug. 

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

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

24 date specified by the Secretary. 


dlhill on DSK3GLQ082PROD with BILLS
23 

HR 5333 PCS

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

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

3 the Secretary shall— 

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

5 with paragraph (1); 

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

7 such final administrative order in the Fed8 eral Register; and 

9 ‘‘(iii) afford sponsors of such drugs 

10 that will be subject to such an order the 

11 opportunity for formal dispute resolution 

12 up to the level of the Director of the Cen13 ter for Drug Evaluation and Research, 

14 which must initially be within 45 calendar 

15 days of the issuance of the order, and for 

16 subsequent levels of appeal, within 30 cal17 endar days of the prior decision. 

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

19 subject to a final order issued under subpara20 graph (D) and that participated in each stage 

21 of formal dispute resolution under clause (iii) of 

22 such subparagraph may request a hearing on 

23 such order. The provisions of subparagraphs 

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

25 paragraph (3)(C)(v)(II), shall apply with reVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
24 

HR 5333 PCS

1 spect to a hearing on such order in the same 

2 manner and to the same extent as such provi3 sions apply with respect to a hearing on an ad4 ministrative order issued under paragraph 

5 (2)(A)(iv). 

6 ‘‘(F) TIMING.— 

7 ‘‘(i) FINAL ORDER AND HEARING.— 

8 The Secretary shall— 

9 ‘‘(I) not later than 6 months 

10 after the date on which the comment 

11 period closes under subparagraph (A) 

12 or (B), issue a final order in accord13 ance with paragraph (1); and 

14 ‘‘(II) not later than 12 months 

15 after the date on which such final 

16 order is issued, complete any hearing 

17 under subparagraph (E). 

18 ‘‘(ii) DISPUTE RESOLUTION RE19 QUEST.—The Secretary shall specify in an 

20 interim final order issued under subpara21 graph (A) or (B) such shorter periods for 

22 requesting dispute resolution under sub23 paragraph (D)(iii) as are necessary to 

24 meet the requirements of this subpara25 graph. 


dlhill on DSK3GLQ082PROD with BILLS
25 

HR 5333 PCS

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

2 issued pursuant to subparagraph (F) shall be 

3 subject to judicial review in accordance with 

4 paragraph (3)(D). 

5 ‘‘(5) ADMINISTRATIVE ORDER INITIATED AT

6 THE REQUEST OF A REQUESTOR.— 

7 ‘‘(A) IN GENERAL.—In issuing an adminis8 trative order under paragraph (1) at the re9 quest of a requestor with respect to certain 

10 drugs, classes of drugs, or combinations of 

11 drugs— 

12 ‘‘(i) the Secretary shall, after receiv13 ing a request under this subparagraph, de14 termine whether the request is sufficiently 

15 complete and formatted to permit a sub16 stantive review; 

17 ‘‘(ii) if the Secretary determines that 

18 the request is sufficiently complete and for19 matted to permit a substantive review, the 

20 Secretary shall— 

21 ‘‘(I) file the request; and 

22 ‘‘(II) initiate proceedings with re23 spect to issuing an administrative 

24 order in accordance with paragraphs 

25 (2) and (3); and 


dlhill on DSK3GLQ082PROD with BILLS
26 

HR 5333 PCS

1 ‘‘(iii) except as provided in paragraph 

2 (6), if the Secretary determines that a re3 quest does not meet the requirements for 

4 filing or is not sufficiently complete and 

5 formatted to permit a substantive review, 

6 the requestor may demand that the request 

7 be filed over protest, and the Secretary 

8 shall initiate proceedings to review the re9 quest in accordance with paragraph (2)(A). 

10 ‘‘(B) REQUEST TO INITIATE PRO11 CEEDINGS.— 

12 ‘‘(i) IN GENERAL.—A requestor seek13 ing an administrative order under para14 graph (1) with respect to certain drugs, 

15 classes of drugs, or combinations of drugs, 

16 shall submit to the Secretary a request to 

17 initiate proceedings for such order in the 

18 form and manner as specified by the Sec19 retary. Such requestor may submit a re20 quest under this subparagraph for the 

21 issuance of an administrative order— 

22 ‘‘(I) determining whether a drug 

23 is generally recognized as safe and ef24 fective within the meaning of section 

25 201(p)(1), exempt from section 


dlhill on DSK3GLQ082PROD with BILLS
27 

HR 5333 PCS

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

2 subject of an approved application 

3 under section 505; or 

4 ‘‘(II) determining whether a 

5 change to a condition of use of a drug 

6 is generally recognized as safe and ef7 fective within the meaning of section 

8 201(p)(1), exempt from section 

9 503(b)(1), and not required to be the 

10 subject of an approved application 

11 under section 505, if, absent such a 

12 changed condition of use, such drug 

13 is— 

14 ‘‘(aa) generally recognized 

15 as safe and effective within the 

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

17 accordance with subsection 

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

19 this subsection; or 

20 ‘‘(bb) subject to subsection 

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

22 initiates such request in conjunc23 tion with a request for the Sec24 retary to determine whether such 

25 drug is generally recognized as 


dlhill on DSK3GLQ082PROD with BILLS
28 

HR 5333 PCS

1 safe and effective within the 

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

3 which is filed by the Secretary 

4 under subparagraph (A)(ii). 

5 ‘‘(ii) EXCEPTION.—The Secretary is 

6 not required to complete review of a re7 quest for a change described in clause 

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

9 there is an inadequate basis to find the 

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

12 201(p)(1) under paragraph (1) and issues 

13 a final order announcing that determina14 tion. 

15 ‘‘(iii) WITHDRAWAL.—The requestor 

16 may withdraw a request under this para17 graph, according to the procedures set 

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

19 Notwithstanding any other provision of 

20 this section, if such request is withdrawn, 

21 the Secretary may cease proceedings under 

22 this subparagraph. 

23 ‘‘(C) EXCLUSIVITY.— 

24 ‘‘(i) IN GENERAL.—A final adminis25 trative order issued in response to a reVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
29 

HR 5333 PCS

1 quest under this section shall have the ef2 fect of authorizing solely the order re3 questor (or the licensees, assignees, or suc4 cessors in interest of such requestor with 

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

6 period of 18 months following the effective 

7 date of such final order, to market drugs— 

8 ‘‘(I) incorporating changes de9 scribed in clause (ii); 

10 ‘‘(II) beginning on the date the 

11 requestor (or any such licensees, as12 signees, or successors in interest) may 

13 lawfully market such drugs pursuant 

14 to the order; and 

15 ‘‘(III) subject to the limitations 

16 under clause (iv). 

17 ‘‘(ii) CHANGES DESCRIBED.—A 

18 change described in this clause is a change 

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

20 which— 

21 ‘‘(I) provides for a drug to con22 tain an active ingredient (including 

23 any ester or salt of the active ingre24 dient) not previously incorporated in a 

25 drug described in clause (iii); or 


dlhill on DSK3GLQ082PROD with BILLS
30 

HR 5333 PCS

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

2 conditions of use of a drug, for which 

3 new human data studies conducted or 

4 sponsored by the requestor (or for 

5 which the requestor has an exclusive 

6 right of reference) were essential to 

7 the issuance of such order. 

8 ‘‘(iii) DRUGS DESCRIBED.—The drugs 

9 described in this clause are drugs— 

10 ‘‘(I) specified in subsection 

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

12 ‘‘(II) subject to a final order 

13 issued under this section; 

14 ‘‘(III) subject to a final sun15 screen order (as defined in section 

16 586(2)(A)); or 

17 ‘‘(IV) described in subsection 

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

19 active enforcement action under chap20 ter III of this Act. 

21 ‘‘(iv) LIMITATIONS ON EXCLU22 SIVITY.— 

23 ‘‘(I) IN GENERAL.—Only one pe24 riod of exclusivity shall be granted, 

25 under each order described in clause 


dlhill on DSK3GLQ082PROD with BILLS
31 

HR 5333 PCS

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

2 drug subject to such order) which are 

3 either— 

4 ‘‘(aa) changes described in 

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

6 ingredients; or 

7 ‘‘(bb) changes described in 

8 clause (ii)(II), relating to condi9 tions of use. 

10 ‘‘(II) NO EXCLUSIVITY AL11 LOWED.—No exclusivity shall apply to 

12 changes to a drug which are— 

13 ‘‘(aa) the subject of a Tier 2 

14 OTC monograph order request 

15 (as defined in section 744N); 

16 ‘‘(bb) safety-related changes, 

17 as defined by the Secretary, or 

18 any other changes the Secretary 

19 considers necessary to assure 

20 safe use; or 

21 ‘‘(cc) changes related to 

22 methods of testing safety or effi23 cacy. 

24 ‘‘(v) NEW HUMAN DATA STUDIES DE25 FINED.—In this subparagraph, the term 


dlhill on DSK3GLQ082PROD with BILLS
32 

HR 5333 PCS

1 ‘new human data studies’ means clinical 

2 trials of safety or effectiveness (including 

3 actual use studies), pharmacokinetics stud4 ies, or bioavailability studies, the results of 

5 which— 

6 ‘‘(I) have not been relied on by 

7 the Secretary to support— 

8 ‘‘(aa) a proposed or final de9 termination that a drug described 

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

11 clause (iii) is generally recognized 

12 as safe and effective within the 

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

14 ‘‘(bb) approval of a drug 

15 that was approved under section 

16 505; and 

17 ‘‘(II) do not duplicate the results 

18 of another study that was relied on by 

19 the Secretary to support— 

20 ‘‘(aa) a proposed or final de21 termination that a drug described 

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

23 clause (iii) is generally recognized 

24 as safe and effective within the 

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


dlhill on DSK3GLQ082PROD with BILLS
33 

HR 5333 PCS

1 ‘‘(bb) approval of a drug 

2 that was approved under section 

3 505. 

4 ‘‘(vi) EFFECTIVE DATE.—A final 

5 order subject to clause (i) shall take effect 

6 on the date when the order requestor (or 

7 the licensees, assignees, or successors in 

8 interest of such requestor with respect to 

9 such order) submits updated drug listing 

10 information under subsection (e) with re11 spect to the change which is permitted 

12 under such order. 

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

14 years after the date of enactment of the 

15 Over-the-Counter Monograph, Safety, In16 novation, and Reform Act of 2018, the 

17 Comptroller General of the United States 

18 shall submit a study to the Committee on 

19 Energy and Commerce of the House of 

20 Representatives and the Committee on 

21 Health, Education, Labor, and Pensions of 

22 the Senate addressing the effectiveness and 

23 overall impact of exclusivity under this sec24 tion, including its impact on consumer ac25 cess. Such study shall include— 


dlhill on DSK3GLQ082PROD with BILLS
34 

HR 5333 PCS

1 ‘‘(I) the number of nonprescrip2 tion drug products that were granted 

3 exclusivity and the indication for 

4 which the nonprescription drug prod5 ucts were determined to be generally 

6 recognized as safe and effective; 

7 ‘‘(II) whether the exclusivity for 

8 such drug products was granted for— 

9 ‘‘(aa) a new active ingre10 dient (including any ester or salt 

11 of the active ingredient); or 

12 ‘‘(bb) changes in the condi13 tions of use of a drug, for which 

14 new human data studies con15 ducted or sponsored by the re16 questor were essential; 

17 ‘‘(III) whether, and to what ex18 tent, the exclusivity impacted the re19 questor’s or sponsor’s decision to de20 velop the drug product; 

21 ‘‘(IV) an analysis of the imple22 mentation of the exclusivity provision 

23 in this subparagraph, including— 


dlhill on DSK3GLQ082PROD with BILLS
35 

HR 5333 PCS

1 ‘‘(aa) the resources used by 

2 the Food and Drug Administra3 tion; 

4 ‘‘(bb) the impact of such 

5 provision on innovation, as well 

6 as research and development in 

7 the nonprescription drug market; 

8 ‘‘(cc) the impact of such 

9 provision on competition in the 

10 nonprescription drug market; 

11 ‘‘(dd) the impact of such 

12 provision on consumer access to 

13 nonprescription drug products; 

14 ‘‘(ee) the impact of such 

15 provision on the prices of non16 prescription drug products; and 

17 ‘‘(ff) whether the adminis18 trative orders initiated by reques19 tors under this section have been 

20 sufficient to encourage the devel21 opment of nonprescription drug 

22 products that would likely not be 

23 otherwise developed, or developed 

24 in as timely a manner; and 


dlhill on DSK3GLQ082PROD with BILLS
36 

HR 5333 PCS

1 ‘‘(V) whether the administrative 

2 orders initiated by requestors under 

3 this section have been sufficient incen4 tive to encourage innovation in the 

5 nonprescription drug market. 

6 ‘‘(6) INFORMATION REGARDING SAFE NON7 PRESCRIPTION MARKETING AND USE AS CONDITION

8 FOR FILING A GENERALLY RECOGNIZED AS SAFE

9 AND EFFECTIVE REQUEST.— 

10 ‘‘(A) IN GENERAL.—In response to a re11 quest under this section that a drug described 

12 in subparagraph (B) be generally recognized as 

13 safe and effective, the Secretary— 

14 ‘‘(i) may file such request, if the re15 quest includes information specified under 

16 subparagraph (C) with respect to safe non17 prescription marketing and use of such 

18 drug; or 

19 ‘‘(ii) if the request fails to include in20 formation specified under subparagraph 

21 (C), shall refuse to file such request and 

22 require that nonprescription marketing of 

23 the drug be pursuant to a new drug appli24 cation as described in subparagraph (D). 


dlhill on DSK3GLQ082PROD with BILLS
37 

HR 5333 PCS

1 ‘‘(B) DRUG DESCRIBED.—A drug de2 scribed in this subparagraph is a nonprescrip3 tion drug which contains an active ingredient 

4 not previously incorporated in a drug— 

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

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

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

8 this section; or 

9 ‘‘(iii) subject to a final sunscreen 

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

11 ‘‘(C) INFORMATION DEMONSTRATING

12 PRIMA FACIE SAFE NONPRESCRIPTION MAR13 KETING AND USE.—Information specified in 

14 this subparagraph, with respect to a request de15 scribed in subparagraph (A)(i), is— 

16 ‘‘(i) information sufficient for a prima 

17 facie demonstration that the drug subject 

18 to such request has a verifiable history of 

19 being marketed and safely used by con20 sumers in the United States as a non21 prescription drug under comparable condi22 tions of use; 

23 ‘‘(ii) if the drug has not been pre24 viously marketed in the United States as a 

25 nonprescription drug, information suffiVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
38 

HR 5333 PCS

1 cient for a prima facie demonstration that 

2 the drug was marketed and safely used 

3 under comparable conditions of marketing 

4 and use in a country listed in section 

5 802(b)(1)(A) or designated by the Sec6 retary in accordance with section 

7 802(b)(1)(B)— 

8 ‘‘(I) for such period of time as 

9 needed to provide reasonable assur10 ances concerning the safe nonprescrip11 tion use of the drug; and 

12 ‘‘(II) during such time was sub13 ject to sufficient monitoring by a reg14 ulatory body considered acceptable by 

15 the Secretary for such monitoring 

16 purposes, including for adverse events 

17 associated with nonprescription use of 

18 the drug; or 

19 ‘‘(iii) if the Secretary determines that 

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

21 is not needed to provide a prima facie dem22 onstration that the drug can be safely mar23 keted and used as a nonprescription drug, 

24 such other information the Secretary deter25 mines is sufficient for such purposes. 


dlhill on DSK3GLQ082PROD with BILLS
39 

HR 5333 PCS

1 ‘‘(D) MARKETING PURSUANT TO NEW

2 DRUG APPLICATION.—In the case of a request 

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

4 subject to such request may be re-submitted for 

5 filing only if— 

6 ‘‘(i) the drug is marketed as a non7 prescription drug, under conditions of use 

8 comparable to the conditions specified in 

9 the request, for such period of time as the 

10 Secretary determines appropriate (not to 

11 exceed 5 consecutive years) pursuant to an 

12 application approved under section 505; 

13 and 

14 ‘‘(ii) during such time period, one mil15 lion retail packages of the drug, or an 

16 equivalent quantity as determined by the 

17 Secretary, were distributed for retail sale, 

18 as determined in such manner as the Sec19 retary finds appropriate. 

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

21 the case of a request involving a drug described 

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

23 2017, if the Secretary refuses to file a request 

24 under this paragraph, the requestor may not 


dlhill on DSK3GLQ082PROD with BILLS
40 

HR 5333 PCS

1 file such request over protest under paragraph 

2 (5)(A)(iii). 

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

4 issued under paragraph (2), (4)(A), or (5) may in5 clude requirements for the packaging of a drug to 

6 encourage use in accordance with labeling. Such re7 quirements may include unit dose packaging, re8 quirements for products intended for use by chil9 dren, requirements to reduce risk of harm from un10 supervised ingestion, and other appropriate require11 ments. This paragraph does not authorize the Food 

12 and Drug Administration to require standards or 

13 testing procedures as described in part 1700 of title 

14 16, Code of Federal Regulations. 

15 ‘‘(8) FINAL AND TENTATIVE FINAL MONO16 GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL

17 ADMINISTRATIVE ORDERS.— 

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

19 tentative final monograph described in subpara20 graph (B) shall be deemed to be a final admin21 istrative order under this subsection and may 

22 be amended, revoked, or otherwise modified in 

23 accordance with the procedures of this sub24 section. 


dlhill on DSK3GLQ082PROD with BILLS
41 

HR 5333 PCS

1 ‘‘(B) MONOGRAPHS DESCRIBED.—For pur2 poses of subparagraph (A), a final monograph 

3 or tentative final monograph is described in this 

4 subparagraph if it— 

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

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

7 subsection (a); and 

8 ‘‘(ii) represents the most recently pro9 mulgated version of such conditions, in10 cluding as modified, in whole or in part, by 

11 any proposed or final rule. 

12 ‘‘(C) DEEMED ORDERS INCLUDE HARMO13 NIZING TECHNICAL AMENDMENTS.—The 

14 deemed establishment of a final administrative 

15 order under subparagraph (A) shall be con16 strued to include any technical amendments to 

17 such order as the Secretary determines nec18 essary to ensure that such order is appro19 priately harmonized, in terms of terminology or 

20 cross-references, with the applicable provisions 

21 of this Act (and regulations thereunder) and 

22 any other orders issued under this section. 

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

24 ‘‘(1) IN GENERAL.—Minor changes in the dos25 age form of a drug that is described in paragraph 


dlhill on DSK3GLQ082PROD with BILLS
42 

HR 5333 PCS

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

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

3 a requestor without the issuance of an order under 

4 subsection (b) if— 

5 ‘‘(A) the requestor maintains such infor6 mation as is necessary to demonstrate that the 

7 change— 

8 ‘‘(i) will not affect the safety or effec9 tiveness of the drug; and 

10 ‘‘(ii) will not materially affect the ex11 tent of absorption or other exposure to the 

12 active ingredient in comparison to a suit13 able reference product; and 

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

15 requirements of an applicable administrative 

16 order issued by the Secretary under paragraph 

17 (3). 

18 ‘‘(2) ADDITIONAL INFORMATION.— 

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

20 shall submit records requested by the Secretary 

21 relating to such a minor change under section 

22 704(a)(4), within 15 business days of receiving 

23 such a request, or such longer period as the 

24 Secretary may provide. 


dlhill on DSK3GLQ082PROD with BILLS
43 

HR 5333 PCS

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

2 Secretary determines that the information con3 tained in such records is not sufficient to dem4 onstrate that the change does not affect the 

5 safety or effectiveness of the drug or materially 

6 affect the extent of absorption or other expo7 sure to the active ingredient, the Secretary— 

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

9 drug in writing; and 

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

11 with a reasonable opportunity to provide 

12 additional information. 

13 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN14 FORMATION.—If the sponsor fails to provide 

15 such additional information within the pre16 scribed time, or if the Secretary determines that 

17 such additional information does not dem18 onstrate that the change does not affect the 

19 safety or effectiveness of the drug or materially 

20 affect the extent of absorption or other expo21 sure to the active ingredient, the drug as modi22 fied is a new drug within the meaning of sec23 tion 201(p) and shall be deemed to be mis24 branded under section 502(ee). 


dlhill on DSK3GLQ082PROD with BILLS
44 

HR 5333 PCS

1 ‘‘(3) DETERMINING WHETHER A CHANGE WILL

2 AFFECT SAFETY OR EFFECTIVENESS.— 

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

4 issue one or more administrative orders speci5 fying requirements for determining whether a 

6 minor change made by a sponsor pursuant to 

7 this subsection will affect the safety or effective8 ness of a drug or materially affect the extent of 

9 absorption or other exposure to an active ingre10 dient in the drug in comparison to a suitable 

11 reference product, together with guidance for 

12 applying those orders to specific dosage forms. 

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

14 and guidance issued by the Secretary under 

15 subparagraph (A) shall take into account rel16 evant public standards and standard practices 

17 for evaluating the quality of drugs, and may 

18 take into account the special needs of popu19 lations, including children. 

20 ‘‘(d) CONFIDENTIALITY OF INFORMATION SUB21 MITTED TO THE SECRETARY.— 

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

23 any information, including reports of testing con24 ducted on the drug or drugs involved, that is sub25 mitted by a requestor in connection with proceedings 


dlhill on DSK3GLQ082PROD with BILLS
45 

HR 5333 PCS

1 on an order under this section (including any minor 

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

3 or confidential information subject to section 

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

5 1905 of title 18, United States Code, shall not be 

6 disclosed to the public unless the requestor consents 

7 to that disclosure. 

8 ‘‘(2) PUBLIC AVAILABILITY.— 

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

10 subparagraph (B), the Secretary shall— 

11 ‘‘(i) make any information submitted 

12 by a requestor in support of a request 

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

14 public not later than the date on which the 

15 proposed order is issued; and 

16 ‘‘(ii) make any information submitted 

17 by any other person with respect to an 

18 order requested (or initiated by the Sec19 retary) under subsection (b), available to 

20 the public upon such submission. 

21 ‘‘(B) LIMITATIONS ON PUBLIC AVAIL22 ABILITY.—Information described in subpara23 graph (A) shall not be made public if— 

24 ‘‘(i) the information pertains to phar25 maceutical quality information, unless such 


dlhill on DSK3GLQ082PROD with BILLS
46 

HR 5333 PCS

1 information is necessary to establish stand2 ards under which a drug is generally rec3 ognized as safe and effective within the 

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

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

6 requestor-initiated request, but the re7 questor withdraws such request, in accord8 ance with withdrawal procedures estab9 lished by the Secretary, before the Sec10 retary issues the proposed order; 

11 ‘‘(iii) the Secretary requests and ob12 tains the information under subsection (c) 

13 and such information is not submitted in 

14 relation to an order under subsection (b); 

15 or 

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

17 contained in raw datasets. 

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

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

20 section shall submit updated drug listing information for 

21 the drug in accordance with section 510(j) within 30 cal22 endar days of the date when the drug is first commercially 

23 marketed, except that a sponsor who was the order re24 questor with respect to an order subject to subsection 

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


dlhill on DSK3GLQ082PROD with BILLS
47 

HR 5333 PCS

1 of such requestor) shall submit updated drug listing infor2 mation on or before the date when the drug is first com3 mercially marketed. 

4 ‘‘(f) APPROVALS UNDER SECTION 505.—The provi5 sions of this section shall not be construed to preclude a 

6 person from seeking or maintaining the approval of a drug 

7 under sections 505(b)(1), 505(b)(2), and 505(j). A deter8 mination under this section that a drug is not subject to 

9 section 503(b)(1), is generally recognized as safe and ef10 fective within the meaning of section 201(p)(1), and is not 

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

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

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

14 that the applicant shall be required to submit for purposes 

15 of such application only information needed to support any 

16 modification of the drug that is not covered by such deter17 mination under this section. 

18 ‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR19 DERS.—The Secretary shall establish, maintain, update 

20 (as determined necessary by the Secretary but no less fre21 quently than annually), and make publicly available, with 

22 respect to orders issued under this section— 

23 ‘‘(1) a repository of each final order and in24 terim final order in effect, including the complete 

25 text of the order; and 


dlhill on DSK3GLQ082PROD with BILLS
48 

HR 5333 PCS

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

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

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

4 and 

5 ‘‘(B) the Secretary’s expectations, if re6 sources permit, for issuance of proposed orders 

7 over a 3-year period. 

8 ‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE9 QUESTORS.—The Secretary shall establish procedures 

10 under which sponsors or requestors may meet with appro11 priate officials of the Food and Drug Administration to 

12 obtain advice on the studies and other information nec13 essary to support submissions under this section and other 

14 matters relevant to the regulation of nonprescription 

15 drugs and the development of new nonprescription drugs 

16 under this section. 

17 ‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE18 QUESTORS.—The Secretary shall establish procedures to 

19 facilitate efficient participation by multiple sponsors or re20 questors in proceedings under this section, including provi21 sion for joint meetings with multiple sponsors or reques22 tors or with organizations nominated by sponsors or re23 questors to represent their interests in a proceeding. 

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

25 this section shall be in electronic format. 


dlhill on DSK3GLQ082PROD with BILLS
49 

HR 5333 PCS

1 ‘‘(k) EFFECT ON EXISTING REGULATIONS GOV2 ERNING NONPRESCRIPTION DRUGS.— 

3 ‘‘(1) REGULATIONS OF GENERAL APPLICA4 BILITY TO NONPRESCRIPTION DRUGS.—Except as 

5 provided in this subsection, nothing in this section 

6 supersedes regulations establishing general require7 ments for nonprescription drugs, including regula8 tions of general applicability contained in parts 201, 

9 250, and 330 of title 21, Code of Federal Regula10 tions, or any successor regulations. The Secretary 

11 shall establish or modify such regulations by means 

12 of rulemaking in accordance with section 553 of title 

13 5, United States Code. 

14 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE15 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

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

17 title 21, Code of Federal Regulations, as in ef18 fect on the day before the date of the enact19 ment of this section, shall be deemed to be a 

20 final order under subsection (b). 

21 ‘‘(B) Regulations in effect on the day be22 fore the date of the enactment of this section, 

23 establishing requirements for specific non24 prescription drugs marketed pursuant to this 

25 section (including such requirements in parts 


dlhill on DSK3GLQ082PROD with BILLS
50 

HR 5333 PCS

1 201 and 250 of title 21, Code of Federal Regu2 lations), shall be deemed to be final orders 

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

4 drugs— 

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

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

7 ‘‘(ii) otherwise subject to an order 

8 under this section. 

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

10 Secretary shall withdraw regulations establishing 

11 final monographs and the procedures governing the 

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

13 other relevant parts of title 21, Code of Federal 

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

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

16 changes to such regulations to ensure conformity 

17 with appropriate terminology and cross references. 

18 Notwithstanding subchapter II of chapter 5 of title 

19 5, United States Code, any such withdrawal or tech20 nical changes shall be made without public notice 

21 and comment and shall be effective upon publication 

22 through notice in the Federal Register (or upon such 

23 date as specified in such notice). 

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

25 that specifies— 


dlhill on DSK3GLQ082PROD with BILLS
51 

HR 5333 PCS

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

2 meetings between the Secretary and sponsors or re3 questors for drugs subject to this section; 

4 ‘‘(2) the format and content of data submis5 sions to the Secretary under this section; 

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

7 Secretary under this section; 

8 ‘‘(4) consolidated proceedings and the proce9 dures for such proceedings where appropriate; and 

10 ‘‘(5) for minor changes in drugs, recommenda11 tions on how to comply with the requirements in or12 ders issued under subsection (c)(3). 

13 ‘‘(m) RULE OF CONSTRUCTION.— 

14 ‘‘(1) IN GENERAL.—This section shall not af15 fect the treatment or status of a nonprescription 

16 drug— 

17 ‘‘(A) that is marketed without an applica18 tion approved under section 505 as of the date 

19 of the enactment of this section; 

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

21 under this section; and 

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

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


dlhill on DSK3GLQ082PROD with BILLS
52 

HR 5333 PCS

1 ‘‘(2) TREATMENT OF PRODUCTS PREVIOUSLY

2 FOUND TO BE SUBJECT TO TIME AND EXTENT RE3 QUIREMENTS.— 

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

5 drug described in subparagraph (B) may only 

6 be lawfully marketed, without an application 

7 approved under section 505, pursuant to an 

8 order issued under this section. 

9 ‘‘(B) A drug described in this subpara10 graph is a drug which, prior to the date of the 

11 enactment of this section, the Secretary had de12 termined in a proposed or final rule to be ineli13 gible for review under the OTC drug review (as 

14 such phrase ‘OTC drug review’ was used in sec15 tion 330.14 of title 21, Code of Federal Regula16 tions, as in effect on the day before the date of 

17 the enactment of this section). 

18 ‘‘(3) PRESERVATION OF AUTHORITY.— 

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

20 construed to preclude or limit the applicability 

21 of any other provision of this Act. 

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

23 construed to prohibit the Secretary from issuing 

24 an order under this section finding a drug to be 

25 not generally recognized as safe and effective 


dlhill on DSK3GLQ082PROD with BILLS
53 

HR 5333 PCS

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

2 Secretary determines appropriate. 

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

4 subject to this section if an exemption for investigational 

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

6 ‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION

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

8 not apply to collections of information made under this 

9 section. 

10 ‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT

11 RULEMAKING AND OTHER REQUIREMENTS.—The re12 quirements of subsection (b) shall apply with respect to 

13 orders issued under this section instead of the require14 ments of subchapter II of chapter 5 of title 5, United 

15 States Code. 

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

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

18 a 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 


dlhill on DSK3GLQ082PROD with BILLS
54 

HR 5333 PCS

1 ‘‘(B) is or will be subject to an administra2 tive order of the Food and Drug Administra3 tion. 

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

5 or group of persons marketing, manufacturing, proc6 essing, or developing a drug.’’. 

7 SEC. 102. MISBRANDING. 

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

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

10 following: 

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

12 to section 505G, is not the subject of an application ap13 proved under section 505, and does not comply with the 

14 requirements under section 505G. 

15 ‘‘(ff) If it is a drug and it was manufactured, pre16 pared, propagated, compounded, or processed in a facility 

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

18 744O.’’. 

19 SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE20 COUNTER DRUG REVIEW. 

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

22 amendments made by this Act) shall apply to any non23 prescription drug which was excluded by the Food and 

24 Drug Administration from the Over-the-Counter Drug Re25 view in accordance with the statement set out at page 


dlhill on DSK3GLQ082PROD with BILLS
55 

HR 5333 PCS

1 9466 of volume 37 of the Federal Register, published on 

2 May 11, 1972. 

3 (b) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to preclude or limit the applica5 bility of any other provision of the Federal Food, Drug, 

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

7 SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT. 

8 (a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC9 TIVE INGREDIENTS.— 

10 (1) APPLICABILITY OF SECTION 505G FOR

11 PENDING SUBMISSIONS.— 

12 (A) IN GENERAL.—A sponsor of a non13 prescription sunscreen active ingredient or com14 bination of nonprescription sunscreen active in15 gredients that, as of the date of enactment of 

16 this Act, is subject to a proposed sunscreen 

17 order under section 586C of the Federal Food, 

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

19 may elect, by means of giving written notifica20 tion to the Secretary of Health and Human 

21 Services within 180 calendar days of the enact22 ment of this Act, to transition into the review 

23 of such ingredient or combination of ingredients 

24 pursuant to the process set out in section 505G 


dlhill on DSK3GLQ082PROD with BILLS
56 

HR 5333 PCS

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

2 as added by section 101 of this Act. 

3 (B) ELECTION EXERCISED.—Upon receipt 

4 by the Secretary of Health and Human Services 

5 of a timely notification under subparagraph 

6 (A)— 

7 (i) the proposed sunscreen order in8 volved is deemed to be a request for an 

9 order under subsection (b) of section 505G 

10 of the Federal Food, Drug, and Cosmetic 

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

12 and 

13 (ii) such order is deemed to have been 

14 accepted for filing under subsection 

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

16 (C) ELECTION NOT EXERCISED.—A spon17 sor of a nonprescription sunscreen active ingre18 dient or combination of nonprescription sun19 screen active ingredients described in subpara20 graph (A) that does not elect for such ingre21 dient or combination of ingredients to be re22 viewed under section 505G of the Federal Food, 

23 Drug, and Cosmetic Act, as added by section 

24 101 of this Act, shall continue to have such in25 gredient or combination of ingredients reviewed 


dlhill on DSK3GLQ082PROD with BILLS
57 

HR 5333 PCS

1 in accordance with section 586C of the Federal 

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

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

4 transition into the review of such ingredient or 

5 combination of ingredients pursuant to the 

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

7 added by section 101 of this Act. 

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

9 terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac10 tive ingredient’’, and ‘‘proposed sunscreen order’’ 

11 have the meanings given to those terms in section 

12 586 of the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 360fff). 

14 (b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 

15 (1) FINAL SUNSCREEN ORDERS.—Paragraph 

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

17 and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend18 ed to read as follows: 

19 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC20 TION 505G.—A final sunscreen order shall be deemed 

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

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

23 586C(b) of the Federal Food, Drug, and Cosmetic 

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


dlhill on DSK3GLQ082PROD with BILLS
58 

HR 5333 PCS

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

2 and inserting the following: 

3 ‘‘(A) IN GENERAL.—A sponsor may re4 quest’’; and 

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

6 ‘‘(B) CONFIDENTIAL MEETINGS.—A spon7 sor may request one or more confidential meet8 ings with respect to a proposed sunscreen order, 

9 including a letter deemed to be a proposed sun10 screen order under paragraph (3), to discuss 

11 matters involving confidential commercial infor12 mation or trade secrets. The Secretary shall 

13 convene a confidential meeting with such spon14 sor in a reasonable time period. If a sponsor re15 quests more than one confidential meeting for 

16 the same proposed sunscreen order, the Sec17 retary may refuse to grant an additional con18 fidential meeting request if the Secretary deter19 mines that such additional confidential meeting 

20 is not reasonably necessary for the sponsor to 

21 advance its proposed sunscreen order, or if the 

22 request for a confidential meeting fails to in23 clude sufficient information upon which to base 

24 a substantive discussion. The Secretary shall 

25 publish a post-meeting summary of each conVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
59 

HR 5333 PCS

1 fidential meeting under this subparagraph that 

2 does not disclose confidential commercial infor3 mation or trade secrets.’’. 

4 (3) SUNSET PROVISION.—Subchapter I of chap5 ter V of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 360fff et seq.) is amended by adding at 

7 the end the following: 

8 ‘‘SEC. 586H. SUNSET. 

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

10 of fiscal year 2022.’’. 

11 (4) TREATMENT OF FINAL SUNSCREEN

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

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

14 (21 U.S.C. 360fff–5). 

15 (c) TREATMENT OF NON-SUNSCREEN TIME AND EX16 TENT APPLICATIONS.— 

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

18 section 586F of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 360fff–6) that was submitted 

20 to the Secretary of Health and Human Services pur21 suant to section 330.14 of title 21, Code of Federal 

22 Regulations, as such provisions were in effect imme23 diately prior to the date of enactment date of this 

24 Act, shall be extinguished as of such date of enact25 ment, subject to paragraph (2). 


dlhill on DSK3GLQ082PROD with BILLS
60 

HR 5333 PCS

1 (2) ORDER REQUEST.—Nothing in paragraph 

2 (1) precludes the submission of an order request 

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

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

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

6 an application extinguished under paragraph (1). 

7 SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPRO8 PRIATE PEDIATRIC INDICATION FOR CER9 TAIN OTC COUGH AND COLD DRUGS. 

10 (a) IN GENERAL.—Subject to subsection (c), the Sec11 retary of Health and Human Services shall, beginning not 

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

13 annually submit to the Committee on Energy and Com14 merce of the House of Representatives and the Committee 

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

16 a letter describing the progress of the Food and Drug Ad17 ministration— 

18 (1) in evaluating the cough and cold monograph 

19 described in subsection (b) with respect to children 

20 under age 6; and 

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

22 monograph to address such children through the 

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

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

25 101 of this Act. 


dlhill on DSK3GLQ082PROD with BILLS
61 

HR 5333 PCS

1 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

2 The cough and cold monograph described in this sub3 section consists of the conditions under which nonprescrip4 tion drugs containing antitussive, expectorant, nasal de5 congestant, or antihistamine active ingredients (or com6 binations thereof) are generally recognized as safe and ef7 fective, as specified in part 341 of title 21, Code of Federal 

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

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

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

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

12 of this Act. 

13 (c) DURATION OF AUTHORITY.—The requirement 

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

15 letter submitted by the Secretary of Health and Human 

16 Services pursuant to such subsection in which the Sec17 retary indicates that the Food and Drug Administration 

18 has completed its evaluation and revised, in a final order, 

19 as applicable, the cough and cold monograph as described 

20 in subsection (a)(2). 

21 TITLE II—USER FEES 

22 SEC. 201. SHORT TITLE; FINDING. 

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

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


dlhill on DSK3GLQ082PROD with BILLS
62 

HR 5333 PCS

1 (b) FINDING.—The Congress finds that the fees au2 thorized by the amendments made in this title will be dedi3 cated to OTC monograph drug activities, as set forth in 

4 the goals identified for purposes of part 10 of subchapter 

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

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

7 Human Services to the Chairman of the Committee on 

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

9 the Chairman of the Committee on Energy and Commerce 

10 of the House of Representatives, as set forth in the Con11 gressional Record. 

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

13 Subchapter C of chapter VII of the Federal Food, 

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

15 amended by inserting after part 9 the following: 

16 ‘‘PART 10—FEES RELATING TO OVER-THE17 COUNTER DRUGS 

18 ‘‘SEC. 744N. DEFINITIONS. 

19 ‘‘In this part: 

20 ‘‘(1) The term ‘affiliate’ means a business enti21 ty that has a relationship with a second business en22 tity if, directly or indirectly— 

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

24 the power to control, the other business entity; 

25 or 


dlhill on DSK3GLQ082PROD with BILLS
63 

HR 5333 PCS

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

2 to control, both of the business entities. 

3 ‘‘(2) The term ‘contract manufacturing organi4 zation facility’ means an OTC monograph drug facil5 ity where neither the owner of such manufacturing 

6 facility nor any affiliate of such owner or facility 

7 sells the OTC monograph drug produced at such fa8 cility directly to wholesalers, retailers, or consumers 

9 in the United States. 

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

11 OTC monograph drug activities’ means the expenses 

12 in connection with OTC monograph drug activities 

13 for— 

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

15 and Drug Administration, contractors of the 

16 Food and Drug Administration, advisory com17 mittees, and costs related to such officers, em18 ployees, and committees and costs related to 

19 contracts with such contractors; 

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

21 acquisition, maintenance, and repair of com22 puter resources; 

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

24 repair of facilities and acquisition, maintenance, 

25 and repair of fixtures, furniture, scientific 


dlhill on DSK3GLQ082PROD with BILLS
64 

HR 5333 PCS

1 equipment, and other necessary materials and 

2 supplies; and 

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

4 and accounting for resources allocated for OTC 

5 monograph drug activities. 

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

7 the unique number automatically generated by Food 

8 and Drug Administration’s Field Accomplishments 

9 and Compliance Tracking System (FACTS) (or any 

10 successor system). 

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

12 nonprescription drug without an approved new drug 

13 application which is governed by the provisions of 

14 section 505G. 

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

16 means activities of the Secretary associated with 

17 OTC monograph drugs and inspection of facilities 

18 associated with such products, including the fol19 lowing activities: 

20 ‘‘(A) The activities necessary for review 

21 and evaluation of OTC monographs and OTC 

22 monograph order requests, including— 

23 ‘‘(i) orders proposing or finalizing ap24 plicable conditions of use for OTC mono25 graph drugs; 


dlhill on DSK3GLQ082PROD with BILLS
65 

HR 5333 PCS

1 ‘‘(ii) orders affecting status regarding 

2 general recognition of safety and effective3 ness of an OTC monograph ingredient or 

4 combination of ingredients under specified 

5 conditions of use; 

6 ‘‘(iii) all OTC monograph drug devel7 opment and review activities, including 

8 intraagency collaboration; 

9 ‘‘(iv) regulation and policy develop10 ment activities related to OTC monograph 

11 drugs; 

12 ‘‘(v) development of product standards 

13 for products subject to review and evalua14 tion; 

15 ‘‘(vi) meetings referred to in section 

16 505G(i); 

17 ‘‘(vii) review of labeling prior to 

18 issuance of orders related to OTC mono19 graph drugs or conditions of use; and 

20 ‘‘(viii) regulatory science activities re21 lated to OTC monograph drugs. 

22 ‘‘(B) Inspections related to OTC mono23 graph drugs. 


dlhill on DSK3GLQ082PROD with BILLS
66 

HR 5333 PCS

1 ‘‘(C) Monitoring of clinical and other re2 search conducted in connection with OTC 

3 monograph drugs. 

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

5 monograph drugs, including— 

6 ‘‘(i) collecting, developing, and review7 ing safety information on OTC monograph 

8 drugs, including adverse event reports; 

9 ‘‘(ii) developing and using improved 

10 adverse event data-collection systems, in11 cluding information technology systems; 

12 and 

13 ‘‘(iii) developing and using improved 

14 analytical tools to assess potential safety 

15 risks, including access to external data16 bases. 

17 ‘‘(E) Other activities necessary for imple18 mentation of section 505G. 

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

20 means a request for an order submitted under sec21 tion 505G(b)(5). 

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

23 request’ means any OTC monograph order request 

24 not determined to be a Tier 2 OTC monograph 

25 order request. 


dlhill on DSK3GLQ082PROD with BILLS
67 

HR 5333 PCS

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

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

3 an OTC monograph order request for— 

4 ‘‘(i) the reordering of existing information 

5 in the drug facts label of an OTC monograph 

6 drug; 

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

8 other information section of the drug facts label 

9 of an OTC monograph drug, as limited by sec10 tion 201.66(c)(7) of title 21, Code of Federal 

11 Regulations (or any successor regulations); 

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

13 section of the drug facts label of an OTC mono14 graph drug, if such changes conform to changes 

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

16 ‘‘(iv) the standardization of the concentra17 tion or dose of a specific finalized ingredient 

18 within a particular finalized monograph; 

19 ‘‘(v) a change to ingredient nomenclature 

20 to align with nomenclature of a standards-set21 ting organization; or 

22 ‘‘(vi) addition of an interchangeable term 

23 in accordance with section 330.1 of title 21, 

24 Code of Federal Regulations (or any successor 

25 regulations). 


dlhill on DSK3GLQ082PROD with BILLS
68 

HR 5333 PCS

1 ‘‘(B) The Secretary may, based on program im2 plementation experience or other factors found ap3 propriate by the Secretary, characterize any OTC 

4 monograph order request as a Tier 2 OTC mono5 graph order request (including recharacterizing a re6 quest from Tier 1 to Tier 2) and publish such deter7 mination in a proposed order issued pursuant to sec8 tion 505G. 

9 ‘‘(10)(A) The term ‘OTC monograph drug facil10 ity’ means a foreign or domestic business or other 

11 entity that— 

12 ‘‘(i) is— 

13 ‘‘(I) under one management, either di14 rect or indirect; and 

15 ‘‘(II) at one geographic location or ad16 dress engaged in manufacturing or proc17 essing the finished dosage form of an OTC 

18 monograph drug; 

19 ‘‘(ii) includes a finished dosage form man20 ufacturer facility in a contractual relationship 

21 with the sponsor of one or more OTC mono22 graph drugs to manufacture or process such 

23 drugs; and 

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

25 entity whose only manufacturing or processing 


dlhill on DSK3GLQ082PROD with BILLS
69 

HR 5333 PCS

1 activities are one or more of the following: pro2 duction of clinical research supplies, or testing. 

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

4 separate buildings or locations within close proximity 

5 are considered to be at one geographic location or 

6 address if the activities conducted in such buildings 

7 or locations are— 

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

9 enterprise; 

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

11 local management; and 

12 ‘‘(iii) under a single FDA establishment 

13 identifier and capable of being inspected by the 

14 Food and Drug Administration during a single 

15 inspection. 

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

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

18 under multiple management, the business or other 

19 entity is deemed to constitute multiple facilities, one 

20 per management entity, for purposes of this para21 graph. 

22 ‘‘(11) The term ‘OTC monograph drug meet23 ing’ means any meeting regarding the content of a 

24 proposed OTC monograph order request. 


dlhill on DSK3GLQ082PROD with BILLS
70 

HR 5333 PCS

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

2 a person. 

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

4 the meanings given such terms in section 505G. 

5 ‘‘SEC. 744O. AUTHORITY TO ASSESS AND USE OTC MONO6 GRAPH FEES. 

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

8 2019, the Secretary shall assess and collect fees in accord9 ance with this section as follows: 

10 ‘‘(1) FACILITY FEE.— 

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

12 owns a facility identified as an OTC monograph 

13 drug facility on December 31 of the fiscal year 

14 or at any time during the preceding 12-month 

15 period shall be assessed an annual fee for each 

16 such facility as determined under subsection 

17 (c). 

18 ‘‘(B) EXCEPTIONS.— 

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

20 subparagraph (A) if the identified OTC 

21 monograph drug facility has ceased all ac22 tivities related to OTC monograph drugs 

23 prior to the date specified in subparagraph 

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

25 reflect such change under the requirements 


dlhill on DSK3GLQ082PROD with BILLS
71 

HR 5333 PCS

1 for drug establishment registration set 

2 forth in section 510. 

3 ‘‘(ii) The amount of the fee for a con4 tract manufacturing organization facility 

shall be equal to 2 5 ⁄3 the amount of the fee 

6 for an OTC monograph drug facility that 

7 is not a contract manufacturing organiza8 tion facility. 

9 ‘‘(C) AMOUNT.—The amount of fees estab10 lished under subparagraph (A) shall be estab11 lished under subsection (c). 

12 ‘‘(D) DUE DATE.— 

13 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

14 fiscal year 2019, the facility fees required 

15 under subparagraph (A) shall be due 45 

16 calendar days after publication of the Fed17 eral Register notice provided for under 

18 subsection (c)(4)(A). 

19 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

20 For each fiscal year after fiscal year 2019, 

21 the facility fees required under subpara22 graph (A) shall be due on the later of— 

23 ‘‘(I) the first business day of 

24 June of such year; or 


dlhill on DSK3GLQ082PROD with BILLS
72 

HR 5333 PCS

1 ‘‘(II) the first business day after 

2 the enactment of an appropriations 

3 Act providing for the collection and 

4 obligation of fees under this section 

5 for such year. 

6 ‘‘(2) OTC MONOGRAPH ORDER REQUEST

7 FEE.— 

8 ‘‘(A) IN GENERAL.—Each person that sub9 mits an OTC monograph order request shall be 

10 subject to a fee for an OTC monograph order 

11 request. The amount of such fee shall be— 

12 ‘‘(i) for a Tier 1 OTC monograph 

13 order request, $500,000, adjusted for in14 flation for the fiscal year (as determined 

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

16 ‘‘(ii) for a Tier 2 OTC monograph 

17 order request, $100,000 adjusted for infla18 tion for the fiscal year (as determined 

19 under subsection (c)(1)(B)). 

20 ‘‘(B) DUE DATE.—The OTC monograph 

21 order request fees required under subparagraph 

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

23 the OTC monograph order request. 

24 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

25 CHANGES.—A person who is named as the reVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00072 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
73 

HR 5333 PCS

1 questor in an OTC monograph order shall not 

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

3 the Secretary finds that the OTC monograph 

4 order request seeks to change the drug facts la5 beling of an OTC monograph drug in a way 

6 that would add to or strengthen— 

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

8 precaution; 

9 ‘‘(ii) a statement about risk associated 

10 with misuse or abuse; or 

11 ‘‘(iii) an instruction about dosage and 

12 administration that is intended to increase 

13 the safe use of the OTC monograph drug. 

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

15 IS RECATEGORIZED AS A TIER 2 OTC MONO16 GRAPH ORDER REQUEST.—If the Secretary de17 termines that an OTC monograph request ini18 tially characterized as Tier 1 shall be re-charac19 terized as a Tier 2 OTC monograph order re20 quest, and the requestor has paid a Tier 1 fee 

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

22 Secretary shall refund the requestor the dif23 ference between the Tier 1 and Tier 2 fees de24 termined under subparagraphs (A)(i) and 

25 (A)(ii), respectively. 


dlhill on DSK3GLQ082PROD with BILLS
74 

HR 5333 PCS

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

2 REFUSED FOR FILING OR WITHDRAWN BEFORE

3 FILING.—The Secretary shall refund 75 percent 

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

5 order request which is refused for filing or was 

6 withdrawn before being accepted or refused for 

7 filing. 

8 ‘‘(F) FEES FOR ORDER REQUESTS PRE9 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

10 BEFORE FILING.—An OTC monograph order 

11 request that was submitted but was refused for 

12 filing, or was withdrawn before being accepted 

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

14 fee under subparagraph (A) upon being resub15 mitted or filed over protest. 

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

17 WITHDRAWN.—If an order request is withdrawn 

18 after the order request was filed, the Secretary 

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

20 substantial work was performed on the order 

21 request after the application was filed. The Sec22 retary shall have the sole discretion to refund a 

23 fee or a portion of the fee under this subpara24 graph. A determination by the Secretary conVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00074 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
75 

HR 5333 PCS

1 cerning a refund under this subparagraph shall 

2 not be reviewable. 

3 ‘‘(3) REFUNDS.— 

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

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

6 paragraph (2), the Secretary shall not refund 

7 any fee paid under paragraph (1) except as pro8 vided in subparagraph (B). 

9 ‘‘(B) DISPUTES CONCERNING FEES.—To 

10 qualify for the return of a fee claimed to have 

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

12 a person shall submit to the Secretary a written 

13 request justifying such return within 180 cal14 endar days after such fee was paid. 

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

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

17 Federal Register the amount of the fees under para18 graph (1) for such fiscal year. 

19 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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

22 generate a total facility fee revenue amount equal to 

23 the sum of— 

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

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


dlhill on DSK3GLQ082PROD with BILLS
76 

HR 5333 PCS

1 ‘‘(B) the dollar amount equal to the oper2 ating reserve adjustment for the fiscal year, if 

3 applicable (as determined under subsection 

4 (c)(2)); and 

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

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

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

8 the fiscal years 2020 through 2023, fees under sub9 section (a)(1) shall be established to generate a total 

10 facility fee revenue amount equal to the sum of— 

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

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

13 ‘‘(B) the dollar amount equal to the infla14 tion adjustment for the fiscal year (as deter15 mined under subsection (c)(1)); 

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

18 applicable (as determined under subsection 

19 (c)(2)); 

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

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

22 ‘‘(E) additional dollar amounts for each 

23 fiscal year as follows: 

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

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


dlhill on DSK3GLQ082PROD with BILLS
77 

HR 5333 PCS

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

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

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

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

5 of the annual base revenue for a fiscal year shall 

6 be— 

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

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

9 the dollar amount of the total revenue amount 

10 established under this subsection for the pre11 vious fiscal year, not including any adjustments 

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

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

14 ‘‘(1) INFLATION ADJUSTMENT.— 

15 ‘‘(A) IN GENERAL.—For purposes of sub16 section (b)(2)(B), the dollar amount of the in17 flation adjustment to the annual base revenue 

18 for fiscal year 2020 and each subsequent fiscal 

19 year shall be equal to the product of— 

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

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

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

24 ‘‘(B) OTC MONOGRAPH ORDER REQUEST

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


dlhill on DSK3GLQ082PROD with BILLS
78 

HR 5333 PCS

1 dollar amount of the inflation adjustment to the 

2 fee for OTC monograph order requests for fis3 cal year 2020 and each subsequent fiscal year 

4 shall be equal to the product of— 

5 ‘‘(i) the applicable fee under sub6 section (a)(2) for the preceding fiscal year; 

7 and 

8 ‘‘(ii) the inflation adjustment percent9 age under subparagraph (C). 

10 ‘‘(C) INFLATION ADJUSTMENT PERCENT11 AGE.—The inflation adjustment percentage 

12 under this subparagraph for a fiscal year is 

13 equal to— 

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

15 2021, the average annual percent change 

16 that occurred in the Consumer Price Index 

17 for urban consumers (Washington-Balti18 more, DC–MD–VA–WV; Not Seasonally 

19 Adjusted; All items; Annual Index) for the 

20 first 3 years of the preceding 4 years of 

21 available data; and 

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

23 2023, the sum of— 

24 ‘‘(I) the average annual percent 

25 change in the cost, per full-time equivVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
79 

HR 5333 PCS

1 alent position of the Food and Drug 

2 Administration, of all personnel com3 pensation and benefits paid with re4 spect to such positions for the first 3 

5 years of the preceding 4 fiscal years, 

6 multiplied by the proportion of per7 sonnel compensation and benefits 

8 costs to total costs of OTC mono9 graph drug activities for the first 3 

10 years of the preceding 4 fiscal years; 

11 and 

12 ‘‘(II) the average annual percent 

13 change that occurred in the Consumer 

14 Price Index for urban consumers 

15 (Washington-Baltimore, DC–MD–VA– 

16 WV; Not Seasonally Adjusted; All 

17 items; Annual Index) for the first 3 

18 years of the preceding 4 years of 

19 available data multiplied by the pro20 portion of all costs other than per21 sonnel compensation and benefits 

22 costs to total costs of OTC mono23 graph drug activities for the first 3 

24 years of the preceding 4 fiscal years. 

25 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 


dlhill on DSK3GLQ082PROD with BILLS
80 

HR 5333 PCS

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

2 and subsequent fiscal years, for purposes of 

3 subsections (b)(1)(B) and (b)(2)(C), the Sec4 retary may, in addition to adjustments under 

5 paragraph (1), further increase the fee revenue 

6 and fees if such an adjustment is necessary to 

7 provide operating reserves of carryover user 

8 fees for OTC monograph drug activities for not 

9 more than the number of weeks specified in 

10 subparagraph (B). 

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

12 weeks specified in this subparagraph is— 

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

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

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

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

17 and 

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

19 ‘‘(C) DECREASE.—If the Secretary has 

20 carryover balances for such process in excess of 

21 10 weeks of the operating reserves referred to 

22 in subparagraph (A), the Secretary shall de23 crease the fee revenue and fees referred to in 

24 such subparagraph to provide for not more than 

25 10 weeks of such operating reserves. 


dlhill on DSK3GLQ082PROD with BILLS
81 

HR 5333 PCS

1 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

2 an adjustment under this paragraph is made, 

3 the rationale for the amount of the increase or 

4 decrease (as applicable) in fee revenue and fees 

5 shall be contained in the annual Federal Reg6 ister notice under paragraph (4) establishing 

7 fee revenue and fees for the fiscal year involved. 

8 ‘‘(3) ADDITIONAL DIRECT COST ADJUST9 MENT.—The Secretary shall, in addition to adjust10 ments under paragraphs (1) and (2), further in11 crease the fee revenue and fees for purposes of sub12 section (b)(2)(D) by an amount equal to— 

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

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

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

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

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

18 ‘‘(4) ANNUAL FEE SETTING.— 

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

20 shall, not later than January 31, 2019— 

21 ‘‘(i) establish OTC monograph drug 

22 facility fees for fiscal year 2019 under sub23 section (a), based on the revenue amount 

24 for such year under subsection (b) and the 


dlhill on DSK3GLQ082PROD with BILLS
82 

HR 5333 PCS

1 adjustments provided under this sub2 section; and 

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

4 and OTC monograph order requests in the 

5 Federal Register. 

6 ‘‘(B) SUBSEQUENT FISCAL YEARS.—The 

7 Secretary shall, not later than January 31 of 

8 each fiscal year that begins after September 30, 

9 2019, establish for each such fiscal year, based 

10 on the revenue amounts under subsection (b) 

11 and the adjustments provided under this sub12 section— 

13 ‘‘(i) OTC monograph drug facility fees 

14 under subsection (a)(1); 

15 ‘‘(ii) OTC monograph order request 

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

17 ‘‘(iii) publish such fee revenue 

18 amounts, facility fees, and OTC mono19 graph order request fees in the Federal 

20 Register. 

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

22 that owns an OTC monograph drug facility shall submit 

23 to the Secretary the information required under this sub24 section each year. Such information shall, for each fiscal 

25 year— 


dlhill on DSK3GLQ082PROD with BILLS
83 

HR 5333 PCS

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

2 for drug establishment registration set forth in sec3 tion 510; and 

4 ‘‘(2) include for each such facility, at a min5 imum, identification of the facility’s business oper6 ation as that of an OTC monograph drug facility. 

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

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

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

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

11 of the due date as specified in subparagraph 

12 (D) of such subsection shall result in the fol13 lowing: 

14 ‘‘(i) The Secretary shall place the fa15 cility on a publicly available arrears list. 

16 ‘‘(ii) All OTC monograph drugs man17 ufactured in such a facility or containing 

18 an ingredient manufactured in such a facil19 ity shall be deemed misbranded under sec20 tion 502(a). 

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

22 penalties under this paragraph shall apply until 

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

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

25 order request submitted by a person subject to fees 


dlhill on DSK3GLQ082PROD with BILLS
84 

HR 5333 PCS

1 under subsection (a) shall be considered incomplete 

2 and shall not be accepted for filing by the Secretary 

3 until all fees owed by such person under this section 

4 have been paid. 

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

6 under this section shall be considered ineligible for 

7 OTC monograph drug meetings until all such fees 

8 owed by such person have been paid. 

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

10 ‘‘(1) IN GENERAL.—Fees authorized under sub11 section (a) shall be collected and available for obliga12 tion only to the extent and in the amount provided 

13 in advance in appropriations Acts. Such fees are au14 thorized to remain available until expended. Such 

15 sums as may be necessary may be transferred from 

16 the Food and Drug Administration salaries and ex17 penses appropriation account without fiscal year lim18 itation to such appropriation account for salaries 

19 and expenses with such fiscal year limitation. The 

20 sums transferred shall be available solely for OTC 

21 monograph drug activities. 

22 ‘‘(2) COLLECTIONS AND APPROPRIATION

23 ACTS.— 

24 ‘‘(A) IN GENERAL.—Subject to subpara25 graph (C), the fees authorized by this section 


dlhill on DSK3GLQ082PROD with BILLS
85 

HR 5333 PCS

1 shall be collected and available in each fiscal 

2 year in an amount not to exceed the amount 

3 specified in appropriation Acts, or otherwise 

4 made available for obligation, for such fiscal 

5 year. 

6 ‘‘(B) USE OF FEES AND LIMITATION.— 

7 The fees authorized by this section shall be 

8 available to defray increases in the costs of the 

9 resources allocated for OTC monograph drug 

10 activities (including increases in such costs for 

11 an additional number of full-time equivalent po12 sitions in the Department of Health and 

13 Human Services to be engaged in such activi14 ties), only if the Secretary allocates for such 

15 purpose an amount for such fiscal year (exclud16 ing amounts from fees collected under this sec17 tion) no less than $12 million, multiplied by the 

18 adjustment factor applicable to the fiscal year 

19 involved under subsection (c)(1). 

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

21 be considered to have met the requirements of 

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

23 funded by appropriations and allocated for OTC 

24 monograph drug activities are not more than 15 


dlhill on DSK3GLQ082PROD with BILLS
86 

HR 5333 PCS

1 percent below the level specified in such sub2 paragraph. 

3 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

4 SUBSEQUENT YEARS.—Payment of fees author5 ized under this section for a fiscal year (after 

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

7 fees, may be accepted by the Secretary in ac8 cordance with authority provided in advance in 

9 a prior year appropriations Act. 

10 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

11 For each of the fiscal years 2019 through 2023, 

12 there is authorized to be appropriated for fees under 

13 this section an amount equal to the total amount of 

14 fees assessed for such fiscal year under this section. 

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

16 where the Secretary does not receive payment of a fee as17 sessed under subsection (a) within 30 calendar days after 

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

19 States Government subject to subchapter II of chapter 37 

20 of title 31, United States Code. 

21 ‘‘(h) CONSTRUCTION.—This section may not be con22 strued to require that the number of full-time equivalent 

23 positions in the Department of Health and Human Serv24 ices, for officers, employers, and advisory committees not 

25 engaged in OTC monograph drug activities, be reduced 


dlhill on DSK3GLQ082PROD with BILLS
87 

HR 5333 PCS

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

2 committees so engaged. 

3 ‘‘SEC. 744P. REAUTHORIZATION; REPORTING REQUIRE4 MENTS. 

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

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

7 end of each fiscal year thereafter for which fees are col8 lected under this part, the Secretary shall prepare and 

9 submit to the Committee on Energy and Commerce of the 

10 House of Representatives and the Committee on Health, 

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

12 concerning the progress of the Food and Drug Adminis13 tration in achieving the goals identified in the letters de14 scribed in section 201(b) of the Over-the-Counter Mono15 graph Safety, Innovation, and Reform Act of 2018 during 

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

17 Drug Administration for meeting such goals. 

18 ‘‘(b) FISCAL REPORT.—Not later than 120 calendar 

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

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

21 the Secretary shall prepare and submit to the Committee 

22 on Energy and Commerce of the House of Representatives 

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

24 Pensions of the Senate a report on the implementation 

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


dlhill on DSK3GLQ082PROD with BILLS
88 

HR 5333 PCS

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

2 collected for such fiscal year. 

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

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

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

6 and Drug Administration. 

7 ‘‘(d) REAUTHORIZATION.— 

8 ‘‘(1) CONSULTATION.—In developing rec9 ommendations to present to the Congress with re10 spect to the goals described in subsection (a), and 

11 plans for meeting the goals, for OTC monograph 

12 drug activities for the first 5 fiscal years after fiscal 

13 year 2023, and for the reauthorization of this part 

14 for such fiscal years, the Secretary shall consult 

15 with— 

16 ‘‘(A) the Committee on Energy and Com17 merce of the House of Representatives; 

18 ‘‘(B) the Committee on Health, Education, 

19 Labor, and Pensions of the Senate; 

20 ‘‘(C) scientific and academic experts; 

21 ‘‘(D) health care professionals; 

22 ‘‘(E) representatives of patient and con23 sumer advocacy groups; and 

24 ‘‘(F) the regulated industry. 


dlhill on DSK3GLQ082PROD with BILLS
89 

HR 5333 PCS

1 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA2 TIONS.—After negotiations with the regulated indus3 try, the Secretary shall— 

4 ‘‘(A) present the recommendations devel5 oped under paragraph (1) to the congressional 

6 committees specified in such paragraph; 

7 ‘‘(B) publish such recommendations in the 

8 Federal Register; 

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

10 days for the public to provide written comments 

11 on such recommendations; 

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

13 may present its views on such recommenda14 tions; and 

15 ‘‘(E) after consideration of such public 

16 views and comments, revise such recommenda17 tions as necessary. 

18 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

19 Not later than January 15, 2023, the Secretary 

20 shall transmit to the Congress the revised rec21 ommendations under paragraph (2), a summary of 

22 the views and comments received under such paraVerDate Sep 11 2014 01:38 Jul 18, 2018 Jkt 079200 PO 00000 Frm 00089 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.PCS H5333

dlhill on DSK3GLQ082PROD with BILLS
90 

HR 5333 PCS

1 graph, and any changes made to the recommenda2 tions in response to such views and comments.’’. 

Passed the House of Representatives July 16, 2018. 

Attest: KAREN L. HAAS, 

Clerk. 


dlhill on DSK3GLQ082PROD with BILLS

dlhill on DSK3GLQ082PROD with BILLS
Calendar No. 518 

115TH CONGRESS 

2D SESSION H. R. 5333 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic 

tion, and for other purposes. marketed without an approved new drug applicaspect to certain nonprescription drugs that are Act to clarify the regulatory framework with reJULY 17, 2018 

Received; read twice and placed on the calendar 


dlhill on DSK3GLQ082PROD with BILLS