I 

115TH CONGRESS 

2D SESSION H. R. 5333 

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

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

IN THE HOUSE OF REPRESENTATIVES 

MARCH 19, 2018 

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

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

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

A BILL 

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

clarify the regulatory framework with respect to certain 

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

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’’. 


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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— 


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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 (6)), 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; 


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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 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 those set 

20 out at part 352 of title 21, Code of Federal Regula21 tions, as published at volume 64 page 27687 of the 

22 Federal Register, except that the applicable require23 ments governing effectiveness and labeling shall be 

24 those specified in section 201.327 of title 21, Code 


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1 of Federal Regulations, subject to the requirements 

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

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; 


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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 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 making that is the most recently applicable 

2 proposal or determination for such drug 

3 issued under part 330 of title 21, Code of 

4 Federal Regulations; 

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

10 general requirements for nonprescription 

11 drugs, and requirements under subsections 

12 (b) or (k); and 

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

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 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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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— 


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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); 


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1 ‘‘(ii) is marketed in conformity with 

2 an administrative order under this sub3 section; 

4 ‘‘(iii) meets the general requirements 

5 for nonprescription drugs; and 

6 ‘‘(iv) meets the requirements specified 

7 in 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— 


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1 ‘‘(i) make reasonable efforts to notify 

2 informally, not later than 2 business days 

3 before the issuance of the proposed order, 

4 sponsors of drugs that will be subject to 

5 the administrative order; 

6 ‘‘(ii) after any such reasonable efforts 

7 of notification— 

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

10 website of the Food and Drug Admin11 istration and include in such order the 

12 reasons for the issuance of such order; 

13 and 

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

16 Federal Register; 

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

19 period with respect to such proposed order 

20 of not less than 45 calendar days; and 

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

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

25 order— 


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1 ‘‘(I) issue the final administrative 

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

4 take effect until the time for request5 ing judicial review under paragraph 

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

7 ‘‘(II) publish a notice of such 

8 final administrative order in the Fed9 eral Register; 

10 ‘‘(III) afford requestors of drugs 

11 that will be subject to such order the 

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

14 the Center for Drug Evaluation and 

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

17 the issuance of the order, and, for 

18 subsequent levels of appeal, within 30 

19 calendar days of the prior decision; 

20 and 

21 ‘‘(IV) except with respect to 

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

23 upon completion of the formal dispute 

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1 lution of their right to request a hear2 ing. 

3 ‘‘(B) EXCEPTIONS.—When issuing an ad4 ministrative order under paragraph (1) on the 

5 Secretary’s initiative proposing to determine 

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

7 generally recognized as safe and effective within 

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

9 shall follow the procedures in subparagraph 

10 (A), except that— 

11 ‘‘(i) the proposed order shall include 

12 notice of— 

13 ‘‘(I) the general categories of 

14 data the Secretary has determined 

15 necessary to establish that the drug is 

16 generally recognized as safe and effec17 tive within the meaning of section 

18 201(p)(1); and 

19 ‘‘(II) the format for submissions 

20 by interested persons; 

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

22 public comment period of no less than 180 

23 calendar days with respect to such pro24 posed order, except when the Secretary de25 termines, for good cause, that a shorter peVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 riod is in the interests of public health; 

2 and 

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

4 such comment period shall include a cer5 tification that the person has submitted all 

6 evidence created, obtained, or received by 

7 that person that is both within the cat8 egories of data identified in the proposed 

9 order and relevant to a determination as to 

10 whether the drug is generally recognized as 

11 safe and effective within the meaning of 

12 section 201(p)(1). 

13 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

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

15 participated in each stage of formal dispute res16 olution under subclause (III) of paragraph 

17 (2)(A)(iv) of an administrative order with re18 spect to a drug may request a hearing con19 cerning a final administrative order issued 

20 under such paragraph with respect to such 

21 drug. Such person must submit a request for a 

22 hearing, which shall be based solely on informa23 tion in the administrative record, to the Sec24 retary not later than 30 calendar days after reVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 ceiving notice of the final decision of the formal 

2 dispute resolution procedure. 

3 ‘‘(B) NO HEARING REQUIRED WITH RE4 SPECT TO ORDERS RELATING TO CERTAIN

5 DRUGS.— 

6 ‘‘(i) IN GENERAL.—The Secretary 

7 shall not be required to provide notice and 

8 an opportunity for a hearing pursuant to 

9 paragraph (2)(A)(iv) if the final adminis10 trative order involved relates to a drug— 

11 ‘‘(I) that is described in sub12 section (a)(3)(A); and 

13 ‘‘(II) with respect to which no 

14 human or non-human data studies rel15 evant to the safety or effectiveness of 

16 such drug have been submitted to the 

17 administrative record since the 

18 issuance of the most recent tentative 

19 final monograph relating to such 

20 drug. 

21 ‘‘(ii) HUMAN DATA STUDIES AND

22 NON-HUMAN DATA DEFINED.—In this sub23 paragraph: 

24 ‘‘(I) The term ‘human data stud25 ies’ means clinical trials of safety or 


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1 effectiveness (including actual use 

2 studies), pharmacokinetics studies, or 

3 bioavailability studies. 

4 ‘‘(II) The term ‘non-human data’ 

5 means data from testing other than 

6 with human subjects which provides 

7 information concerning safety or ef8 fectiveness. 

9 ‘‘(C) HEARING PROCEDURES.— 

10 ‘‘(i) DENIAL OF REQUEST FOR HEAR11 ING.—If the Secretary determines that in12 formation submitted in a request for a 

13 hearing under subparagraph (A) with re14 spect to a final administrative order issued 

15 under paragraph (2)(A)(iv), does not iden16 tify the existence of a genuine and sub17 stantial question of material fact, the Sec18 retary may deny such request. In making 

19 such a determination, the Secretary may 

20 consider only information and data that 

21 are based on relevant and reliable scientific 

22 principles and methodologies. 

23 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

24 RELATED REQUESTS.—If more than one 

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1 spect to the same administrative order 

2 under subparagraph (A), the Secretary 

3 may direct that a single hearing be con4 ducted in which all persons whose hearing 

5 requests were granted may participate. 

6 ‘‘(iii) PRESIDING OFFICER.—The pre7 siding officer of a hearing requested under 

8 subparagraph (A) shall— 

9 ‘‘(I) be designated by the Sec10 retary; 

11 ‘‘(II) not be an employee of the 

12 Center for Drug Evaluation and Re13 search; and 

14 ‘‘(III) not have been previously 

15 involved in the development of the ad16 ministrative order involved or pro17 ceedings relating to that administra18 tive order. 

19 ‘‘(iv) RIGHTS OF PARTIES TO HEAR20 ING.—The parties to a hearing requested 

21 under subparagraph (A) shall have the 

22 right to present testimony, including testi23 mony of expert witnesses, and to cross-ex24 amine witnesses presented by other parties. 

25 Where appropriate, the presiding officer 


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1 may require that cross-examination by par2 ties representing substantially the same in3 terests be consolidated to promote effi4 ciency and avoid duplication. 

5 ‘‘(v) FINAL DECISION.— 

6 ‘‘(I) At the conclusion of a hear7 ing requested under subparagraph 

8 (A), the presiding officer of the hear9 ing shall issue a decision containing 

10 findings of fact and conclusions of 

11 law. The decision of the presiding offi12 cer shall be final. 

13 ‘‘(II) The final decision may not 

14 take effect until the period under sub15 paragraph (D)(ii) for submitting a re16 quest for judicial review of such deci17 sion expires. 

18 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN19 ISTRATIVE ORDER.— 

20 ‘‘(i) IN GENERAL.—The procedures 

21 described in section 505(h) shall apply 

22 with respect to judicial review of final ad23 ministrative orders issued under this sub24 section in the same manner and to the 

25 same extent as such section applies to an 


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1 order described in such section except that 

2 the judicial review shall be taken by filing 

3 in an appropriate district court of the 

4 United States in lieu of the appellate 

5 courts specified in such section. 

6 ‘‘(ii) PERIOD TO SUBMIT A REQUEST

7 FOR JUDICIAL REVIEW.—A person eligible 

8 to request a hearing under this paragraph 

9 and seeking judicial review of a final ad10 ministrative order issued under this sub11 section shall file such request for judicial 

12 review not later than 60 calendar days 

13 after the latest of— 

14 ‘‘(I) the date on which notice of 

15 such order is published; 

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

17 with respect to such order is denied 

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

19 ‘‘(III) the date on which a final 

20 decision is made following a hearing 

21 under subparagraph (C)(v); or 

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

23 the date on which the time for re24 questing a hearing expires. 


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1 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT

2 TO ADMINISTRATIVE ORDERS INITIATED BY THE

3 SECRETARY.— 

4 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

5 HEALTH.— 

6 ‘‘(i) IN GENERAL.—In the case of a 

7 determination by the Secretary that a 

8 drug, class of drugs, or combination of 

9 drugs subject to this section poses an im10 minent hazard to the public health, the 

11 Secretary, after first making reasonable ef12 forts to notify, not later than 48 hours be13 fore issuance of such order under this sub14 paragraph, sponsors who have a listing in 

15 effect under section 510(j) for such drug 

16 or combination of drugs— 

17 ‘‘(I) may issue an interim final 

18 administrative order for such drug, 

19 class of drugs, or combination of 

20 drugs under paragraph (1), together 

21 with a detailed statement of the rea22 sons for such order; 

23 ‘‘(II) shall publish in the Federal 

24 Register a notice of availability of any 

25 such order; and 


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1 ‘‘(III) shall provide for a public 

2 comment period of at least 45 cal3 endar days with respect to such in4 terim final order. 

5 ‘‘(ii) NONDELEGATION.—The Sec6 retary may not delegate the authority to 

7 issue an interim final administrative order 

8 under this subparagraph. 

9 ‘‘(B) SAFETY LABELING CHANGES.— 

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

11 determination by the Secretary that a 

12 change in the labeling of a drug, class of 

13 drugs, or combination of drugs subject to 

14 this section is reasonably expected to miti15 gate a significant or unreasonable risk of 

16 a serious adverse event associated with use 

17 of the drug, the Secretary may— 

18 ‘‘(I) make reasonable efforts to 

19 notify informally, not later than 48 

20 hours before the issuance of the in21 terim final order, the sponsors of 

22 drugs who have a listing in effect 

23 under section 510(j) for such drug or 

24 combination of drugs; 


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1 ‘‘(II) after reasonable efforts of 

2 notification, issue an interim final ad3 ministrative order in accordance with 

4 paragraph (1) to require such change, 

5 together with a detailed statement of 

6 the reasons for such order; 

7 ‘‘(III) publish in the Federal 

8 Register a notice of availability of 

9 such order; and 

10 ‘‘(IV) provide for a public com11 ment period of at least 45 calendar 

12 days with respect to such interim final 

13 order. 

14 ‘‘(ii) CONTENT OF ORDER.—An in15 terim final order issued under this sub16 paragraph with respect to the labeling of a 

17 drug may provide for new warnings and 

18 other information required for safe use of 

19 the drug. 

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

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

22 date specified by the Secretary. 

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

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

25 the Secretary shall— 


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

2 with paragraph (1); 

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

4 such final administrative order in the Fed5 eral Register; and 

6 ‘‘(iii) afford sponsors of such drugs 

7 that will be subject to such an order the 

8 opportunity for formal dispute resolution 

9 up to the level of the Director of the Cen10 ter for Drug Evaluation and Research, 

11 which must initially be within 45 calendar 

12 days of the issuance of the order, and for 

13 subsequent levels of appeal, within 30 cal14 endar days of the prior decision. 

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

16 subject to a final order issued under subpara17 graph (D) and that participated in each stage 

18 of formal dispute resolution under clause (iii) of 

19 such subparagraph may request a hearing on 

20 such order. The provisions of subparagraphs 

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

22 paragraph (3)(C)(v)(II), shall apply with re23 spect to a hearing on such order in the same 

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1 ministrative order issued under paragraph 

2 (2)(A)(iv). 

3 ‘‘(F) TIMING.—Not later than 12 months 

4 after the date on which an interim final order 

5 is issued under subparagraph (A) or (B), the 

6 Secretary shall issue a final order in accordance 

7 with paragraph (1) and complete any required 

8 hearing. 

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

10 issued pursuant to subparagraph (F) shall be 

11 subject to judicial review in accordance with 

12 paragraph (3)(D). 

13 ‘‘(5) ADMINISTRATIVE ORDER INITIATED AT

14 THE REQUEST OF A REQUESTOR.— 

15 ‘‘(A) IN GENERAL.—In issuing an adminis16 trative order under paragraph (1) at the re17 quest of a requestor with respect to certain 

18 drugs, classes of drugs, or combinations of 

19 drugs— 

20 ‘‘(i) the Secretary shall, after receiv21 ing a request under this subparagraph, de22 termine whether the request is sufficiently 

23 complete and formatted to permit a sub24 stantive review; 


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1 ‘‘(ii) if the Secretary determines that 

2 the request is sufficiently complete and for3 matted to permit a substantive review, the 

4 Secretary shall— 

5 ‘‘(I) file the request; and 

6 ‘‘(II) initiate proceedings with re7 spect to issuing an administrative 

8 order in accordance with paragraphs 

9 (2) and (3); and 

10 ‘‘(iii) except as provided in paragraph 

11 (6), if the Secretary determines that a re12 quest does not meet the requirements for 

13 filing or is not sufficiently complete and 

14 formatted to permit a substantive review, 

15 the requestor may demand that the request 

16 be filed over protest, and the Secretary 

17 shall initiate proceedings to review the re18 quest in accordance with paragraph (2)(A). 

19 ‘‘(B) REQUEST TO INITIATE PRO20 CEEDINGS.— 

21 ‘‘(i) IN GENERAL.—A requestor seek22 ing an administrative order under para23 graph (1) with respect to certain drugs, 

24 classes of drugs, or combinations of drugs, 

25 shall submit to the Secretary a request to 


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1 initiate proceedings for such order in the 

2 form and manner as specified by the Sec3 retary. Such requestor may submit a re4 quest under this subparagraph for the 

5 issuance of an administrative order— 

6 ‘‘(I) determining whether a drug 

7 is generally recognized as safe and ef8 fective within the meaning of section 

9 201(p)(1), exempt from section 

10 503(b)(1), and not required to be the 

11 subject of an approved application 

12 under section 505; or 

13 ‘‘(II) determining whether a 

14 change to a condition of use of a drug 

15 is generally recognized as safe and ef16 fective within the meaning of section 

17 201(p)(1), exempt from section 

18 503(b)(1), and not required to be the 

19 subject of an approved application 

20 under section 505, if such drug is— 

21 ‘‘(aa) absent such a changed 

22 condition of use, generally recog23 nized as safe and effective within 

24 the meaning of section 201(p)(1) 

25 in accordance with subsection 


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

2 this subsection; or 

3 ‘‘(bb) subject to subsection 

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

5 initiates such request in conjunc6 tion with a request for the Sec7 retary to determine whether such 

8 drug is generally recognized as 

9 safe and effective within the 

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

11 which is filed by the Secretary 

12 under subparagraph (A)(ii). 

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

14 not required to complete review of a re15 quest for a change described in clause 

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

17 there is an inadequate basis to find the 

18 drug is generally recognized as safe and ef19 fective within the meaning of section 

20 201(p)(1) under paragraph (1) and issues 

21 a final order announcing that determina22 tion. 

23 ‘‘(iii) WITHDRAWAL.—The requestor 

24 may withdraw a request under this para25 graph, according to the procedures set 


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

2 Notwithstanding any other provision of 

3 this section, if such request is withdrawn, 

4 the Secretary may cease proceedings under 

5 this subparagraph. 

6 ‘‘(C) EXCLUSIVITY.— 

7 ‘‘(i) IN GENERAL.—A final adminis8 trative order issued in response to a re9 quest under this section shall have the ef10 fect of authorizing solely the order re11 questor (or the licensees, assignees, or suc12 cessors in interest of such requestor with 

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

14 period of 18 months following the effective 

15 date of such final order, to market drugs— 

16 ‘‘(I) incorporating changes de17 scribed in clause (ii); 

18 ‘‘(II) beginning on the date the 

19 requestor (or any such licensees, as20 signees, or successors in interest) may 

21 lawfully market such drugs pursuant 

22 to the order; and 

23 ‘‘(III) subject to the limitations 

24 under clause (iv). 


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1 ‘‘(ii) CHANGES DESCRIBED.—A 

2 change described in this clause is a change 

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

4 which— 

5 ‘‘(I) provides for a drug to con6 tain an active ingredient (including 

7 any ester or salt of the active ingre8 dient) not previously incorporated in a 

9 drug described in clause (iii); or 

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

11 conditions of use of a drug, for which 

12 new human data studies conducted or 

13 sponsored by the requestor (or for 

14 which the requestor has an exclusive 

15 right of reference) were essential to 

16 the issuance of such order. 

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

18 described in this clause are drugs— 

19 ‘‘(I) specified in subsection 

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

21 ‘‘(II) subject to a final order 

22 issued under this section; 

23 ‘‘(III) subject to a final sun24 screen order (as defined in section 

25 586(2)(A)); or 


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1 ‘‘(IV) described in subsection 

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

3 active enforcement action under chap4 ter III of this Act. 

5 ‘‘(iv) LIMITATIONS ON EXCLU6 SIVITY.— 

7 ‘‘(I) IN GENERAL.—Only one pe8 riod of exclusivity shall be granted, 

9 under each order described in clause 

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

11 drug subject to such order) which are 

12 either— 

13 ‘‘(aa) changes described in 

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

15 ingredients; or 

16 ‘‘(bb) changes described in 

17 clause (ii)(II), relating to condi18 tions of use. 

19 ‘‘(II) NO EXCLUSIVITY AL20 LOWED.—No exclusivity shall apply to 

21 changes to a drug which are— 

22 ‘‘(aa) the subject of a Tier 2 

23 OTC monograph order request 

24 (as defined in section 744N); 


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1 ‘‘(bb) safety-related changes, 

2 as defined by the Secretary, or 

3 any other changes the Secretary 

4 considers necessary to assure 

5 safe use; or 

6 ‘‘(cc) changes related to 

7 methods of testing safety or effi8 cacy. 

9 ‘‘(v) NEW HUMAN DATA STUDIES DE10 FINED.—In this subparagraph, the term 

11 ‘new human data studies’ means clinical 

12 trials of safety or effectiveness (including 

13 actual use studies), pharmacokinetics stud14 ies, or bioavailability studies, the results of 

15 which— 

16 ‘‘(I) have not been relied on by 

17 the Secretary to support— 

18 ‘‘(aa) a proposed or final de19 termination that a drug described 

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

21 clause (iii) is generally recognized 

22 as safe and effective within the 

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

24 ‘‘(bb) approval of a drug 

25 that was approved under section 


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1 505 (except for an approval 

2 changing a drug from prescrip3 tion to nonprescription status); 

4 and 

5 ‘‘(II) do not duplicate the results 

6 of another study that was 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 (except for an approval 

17 changing a drug from prescrip18 tion to nonprescription status). 

19 ‘‘(vi) EFFECTIVE DATE.—A final 

20 order subject to clause (i) shall take effect 

21 on the date when the order requestor (or 

22 the licensees, assignees, or successors in 

23 interest of such requestor with respect to 

24 such order) submits updated drug listing 

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1 spect to the change which is permitted 

2 under such order. 

3 ‘‘(6) INFORMATION REGARDING SAFE NON4 PRESCRIPTION MARKETING AND USE AS CONDITION

5 FOR FILING A GENERALLY RECOGNIZED AS SAFE

6 AND EFFECTIVE REQUEST.— 

7 ‘‘(A) IN GENERAL.—In response to a re8 quest under this section that a drug described 

9 in subparagraph (B) be generally recognized as 

10 safe and effective, the Secretary— 

11 ‘‘(i) may file such request, if the re12 quest includes information specified under 

13 subparagraph (C) with respect to safe non14 prescription marketing and use of such 

15 drug; or 

16 ‘‘(ii) if the request fails to include in17 formation specified under subparagraph 

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

19 require that nonprescription marketing of 

20 the drug be pursuant to a new drug appli21 cation as described in subparagraph (D). 

22 ‘‘(B) DRUG DESCRIBED.—A drug de23 scribed in this subparagraph is a nonprescrip24 tion drug which contains an active ingredient 

25 not previously incorporated in a drug— 


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

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

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

4 this section; or 

5 ‘‘(iii) subject to a final sunscreen 

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

7 ‘‘(C) INFORMATION DEMONSTRATING

8 PRIMA FACIE SAFE NONPRESCRIPTION MAR9 KETING AND USE.—Information specified in 

10 this subparagraph, with respect to a request de11 scribed in subparagraph (A)(i), is— 

12 ‘‘(i) information sufficient for a prima 

13 facie demonstration that the drug subject 

14 to such request has a verifiable history of 

15 being marketed and safely used by con16 sumers in the United States as a non17 prescription drug under comparable condi18 tions of use; 

19 ‘‘(ii) if the drug has not been pre20 viously marketed in the United States as a 

21 nonprescription drug, information suffi22 cient for a prima facie demonstration that 

23 the drug was marketed and safely used 

24 under comparable conditions of marketing 

25 and use in a country listed in section 


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1 802(b)(1)(A) or designated by the Sec2 retary in accordance with section 

3 802(b)(1)(B)— 

4 ‘‘(I) for such period of time as 

5 needed to provide reasonable assur6 ances concerning the safe nonprescrip7 tion use of the drug; and 

8 ‘‘(II) during such time was sub9 ject to sufficient monitoring by a reg10 ulatory body considered acceptable by 

11 the Secretary for such monitoring 

12 purposes, including for adverse events 

13 associated with nonprescription use of 

14 the drug; or 

15 ‘‘(iii) if the Secretary determines that 

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

17 is not needed to provide a prima facie dem18 onstration that the drug can be safely mar19 keted and used as a nonprescription drug, 

20 such other information the Secretary deter21 mines is sufficient for such purposes. 

22 ‘‘(D) MARKETING PURSUANT TO NEW

23 DRUG APPLICATION.—In the case of a request 

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


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1 subject to such request may be re-submitted for 

2 filing only if— 

3 ‘‘(i) the drug is marketed as a non4 prescription drug, under conditions of use 

5 comparable to the conditions specified in 

6 the request, for such period of time as the 

7 Secretary determines appropriate (not to 

8 exceed five consecutive years) pursuant to 

9 an application approved under section 505; 

10 and 

11 ‘‘(ii) during such time period, one mil12 lion retail packages of the drug, or an 

13 equivalent quantity as determined by the 

14 Secretary, were distributed for retail sale, 

15 as determined in such manner as the Sec16 retary finds appropriate. 

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

18 the case of a request involving a drug described 

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

20 2017, if the Secretary refuses to file a request 

21 under this paragraph, the requestor may not 

22 file such request over protest under paragraph 

23 (5)(A)(iii). 

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

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1 clude requirements for the packaging of a drug to 

2 encourage use in accordance with labeling. Such re3 quirements may include unit dose packaging, re4 quirements for products intended for use by chil5 dren, requirements to reduce risk of harm from un6 supervised ingestion, and other appropriate require7 ments. This paragraph does not authorize the Food 

8 and Drug Administration to require standards or 

9 testing procedures as described in part 1700 of title 

10 16, Code of Federal Regulations. 

11 ‘‘(8) FINAL AND TENTATIVE FINAL MONO12 GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL

13 ADMINISTRATIVE ORDERS.— 

14 ‘‘(A) IN GENERAL.—Subject to subpara15 graph (B), a final monograph or tentative final 

16 monograph establishing conditions of use for a 

17 drug described in subsection (a)(1), shall be 

18 deemed to be a final administrative order under 

19 this subsection and may be amended, revoked, 

20 or otherwise modified in accordance with the 

21 procedures of this subsection. 

22 ‘‘(B) DEEMED ORDERS INCLUDE HARMO23 NIZING TECHNICAL AMENDMENTS.—The 

24 deemed establishment of a final administrative 

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1 strued to include any technical amendments to 

2 such order as the Secretary determines nec3 essary to ensure that such order is appro4 priately harmonized, in terms of terminology or 

5 cross-references, with the applicable provisions 

6 of this Act (and regulations thereunder) and 

7 any other orders issued under this section. 

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

9 ‘‘(1) IN GENERAL.—Minor changes in the dos10 age form of a drug that is described in paragraph 

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

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

13 a requestor without the issuance of an order under 

14 subsection (b) if— 

15 ‘‘(A) the requestor maintains such infor16 mation as is necessary to demonstrate that the 

17 change— 

18 ‘‘(i) will not affect the safety or effec19 tiveness of the drug; and 

20 ‘‘(ii) will not materially affect the ex21 tent of absorption or other exposure to the 

22 active ingredient in comparison to a suit23 able reference product; and 

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

25 requirements of an applicable administrative 


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1 order issued by the Secretary under paragraph 

2 (3). 

3 ‘‘(2) ADDITIONAL INFORMATION.— 

4 ‘‘(A) ACCESS TO RECORDS.—A sponsor 

5 shall submit records requested by the Secretary 

6 relating to such a minor change under section 

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

8 such a request, or such longer period as the 

9 Secretary may provide. 

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

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

14 safety or effectiveness of the drug or materially 

15 affect the extent of absorption or other expo16 sure to the active ingredient, the Secretary— 

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

18 drug in writing; and 

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

20 with a reasonable opportunity to provide 

21 additional information. 

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

24 such additional information within the pre25 scribed time, or if the Secretary determines that 


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1 such additional information does not dem2 onstrate that the change does not affect the 

3 safety or effectiveness of the drug or materially 

4 affect the extent of absorption or other expo5 sure to the active ingredient, the drug as modi6 fied is a new drug within the meaning of sec7 tion 201(p) and shall be deemed to be mis8 branded under section 502(ee). 

9 ‘‘(3) DETERMINING WHETHER A CHANGE WILL

10 AFFECT SAFETY OR EFFECTIVENESS.— 

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

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

14 minor change made by a sponsor pursuant to 

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

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

19 reference product, together with guidance for 

20 applying those orders to specific dosage forms. 

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

22 and guidance issued by the Secretary under 

23 subparagraph (A) shall take into account rel24 evant public standards and standard practices 

25 for evaluating the quality of drugs, and may 


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1 take into account the special needs of popu2 lations, including children. 

3 ‘‘(d) CONFIDENTIALITY OF INFORMATION SUB4 MITTED BY REQUESTORS.— 

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

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

9 on an order under this section (including any minor 

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

11 or confidential information subject to section 

12 552(b)(4) of title 5, United States Code, or section 

13 1905 of title 18, United States Code, shall not be 

14 disclosed to the public unless the requestor consents 

15 to that disclosure. 

16 ‘‘(2) PUBLIC AVAILABILITY.—Notwithstanding 

17 paragraph (1), the Secretary shall make available to 

18 the public any information (other than raw data 

19 sets) submitted by a requestor in support of a re20 quest under subsection (b)(5)(A) as of the date on 

21 which the proposed order is made public unless— 

22 ‘‘(A) the information pertains to pharma23 ceutical quality information except to the extent 

24 that specific information is necessary to estab25 lish standards under which a drug is generally 


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1 recognized as safe and effective within the 

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

3 ‘‘(B) the information is submitted in a re4 questor-initiated request, but the requestor 

5 withdraws such request, in accordance with 

6 withdrawal procedures established by the Sec7 retary, before the Secretary issues the proposed 

8 order; or 

9 ‘‘(C) the Secretary obtains the information 

10 under subsection (c). 

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

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

13 section shall submit updated drug listing information for 

14 the drug in accordance with section 510(j) within 30 cal15 endar days of the date when the drug is first commercially 

16 marketed, except that a sponsor who was the order re17 questor with respect to an order subject to subsection 

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

19 of such requestor) shall submit updated drug listing infor20 mation on or before the date when the drug is first com21 mercially marketed. 

22 ‘‘(f) APPROVALS UNDER SECTION 505.—The provi23 sions of this section shall not be construed to preclude a 

24 person from seeking or maintaining the approval of a drug 

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1 mination under this section that a drug is not subject to 

2 section 503(b)(1), is generally recognized as safe and ef3 fective within the meaning of section 201(p)(1), and is not 

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

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

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

7 that the applicant shall be required to submit for purposes 

8 of such application only information needed to support any 

9 modification of the drug that is not covered by such deter10 mination under this section. 

11 ‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR12 DERS.—The Secretary shall establish, maintain, update 

13 (as determined necessary by the Secretary but no less fre14 quently than annually), and make publicly available, with 

15 respect to orders issued under this section— 

16 ‘‘(1) a repository of each final order and in17 terim final order in effect, including the complete 

18 text of the order; and 

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

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

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

22 and 

23 ‘‘(B) the Secretary’s expectations, if re24 sources permit, for issuance of proposed orders 

25 over a three-year period. 


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1 ‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE2 QUESTORS.—The Secretary shall establish procedures 

3 under which sponsors or requestors may meet with appro4 priate officials of the Food and Drug Administration to 

5 obtain advice on the studies and other information nec6 essary to support submissions under this section and other 

7 matters relevant to the regulation of nonprescription 

8 drugs and the development of new nonprescription drugs 

9 under this section. 

10 ‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE11 QUESTORS.—The Secretary shall establish procedures to 

12 facilitate efficient participation by multiple sponsors or re13 questors in proceedings under this section, including provi14 sion for joint meetings with multiple sponsors or reques15 tors or with organizations nominated by sponsors or re16 questors to represent their interests in a proceeding. 

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

18 this section shall be in electronic format. 

19 ‘‘(k) EFFECT ON EXISTING REGULATIONS GOV20 ERNING NONPRESCRIPTION DRUGS.— 

21 ‘‘(1) REGULATIONS OF GENERAL APPLICA22 BILITY TO NONPRESCRIPTION DRUGS.—Except as 

23 provided in this subsection, nothing in this section 

24 supersedes regulations establishing general require25 ments for nonprescription drugs, including regulaVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 tions of general applicability contained in parts 201, 

2 250, and 330 of title 21, Code of Federal Regula3 tions, or any successor regulations. The Secretary 

4 shall establish or modify such regulations by means 

5 of rulemaking in accordance with section 553 of title 

6 5, United States Code. 

7 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE8 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

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

10 title 21, Code of Federal Regulations, as in ef11 fect on the day before the date of the enact12 ment of this section, shall be deemed to be a 

13 final order under subsection (b). 

14 ‘‘(B) Regulations in effect on the day be15 fore the date of the enactment of this section, 

16 establishing requirements for specific non17 prescription drugs marketed pursuant to this 

18 section (including such requirements in parts 

19 201 and 250 of title 21, Code of Federal Regu20 lations), shall be deemed to be final orders 

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

22 drugs subject to paragraphs (1), (2), (3), and 

23 (6) of subsection (a). 

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

25 Secretary shall withdraw regulations establishing 


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1 final monographs and the procedures governing the 

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

3 other relevant parts of title 21, Code of Federal 

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

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

6 changes to such regulations to ensure conformity 

7 with appropriate terminology and cross references. 

8 Notwithstanding subchapter II of chapter 5 of title 

9 5, United States Code, any such withdrawal or tech10 nical changes shall be made without public notice 

11 and comment and shall be effective upon publication 

12 through notice in the Federal Register (or upon such 

13 date as specified in such notice). 

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

15 that specifies— 

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

17 meetings between the Secretary and sponsors or re18 questors for drugs subject to this section; 

19 ‘‘(2) the format and content of data submis20 sions to the Secretary under this section; 

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

22 Secretary under this section; 

23 ‘‘(4) consolidated proceedings and the proce24 dures for such proceedings where appropriate; and 


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1 ‘‘(5) for minor changes in drugs, recommenda2 tions on how to comply with the requirements in or3 ders issued under subsection (c)(3). 

4 ‘‘(m) RULE OF CONSTRUCTION.— 

5 ‘‘(1) IN GENERAL.—This section shall not af6 fect the treatment or status of a nonprescription 

7 drug— 

8 ‘‘(A) that is marketed without an applica9 tion approved under section 505 as of the date 

10 of the enactment of this section; 

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

12 under this section; and 

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

14 (5), or (6) of subsection (a) do not apply. 

15 ‘‘(2) TREATMENT OF PRODUCTS PREVIOUSLY

16 FOUND TO BE SUBJECT TO TIME AND EXTENT RE17 QUIREMENTS.— 

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

19 drug described in subparagraph (B) may only 

20 be lawfully marketed, without an application 

21 approved under section 505, pursuant to an 

22 order issued under this section. 

23 ‘‘(B) A drug described in this subpara24 graph is a drug which, prior to the date of the 

25 enactment of this section, the Secretary had deVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 termined in a proposed or final rule to be ineli2 gible for review under the OTC drug review (as 

3 such phrase ‘OTC drug review’ was used in sec4 tion 330.14 of title 21, Code of Federal Regula5 tions, as in effect on the day before the date of 

6 the enactment of this section). 

7 ‘‘(3) PRESERVATION OF AUTHORITY.— 

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

9 construed to preclude or limit the applicability 

10 of any other provision of this Act. 

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

12 construed to prohibit the Secretary from issuing 

13 an order under this section finding a drug to be 

14 not generally recognized as safe and effective 

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

16 Secretary determines appropriate. 

17 ‘‘(n) INAPPLICABILITY OF PAPERWORK REDUCTION

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

19 not apply to collections of information made under this 

20 section. 

21 ‘‘(o) INAPPLICABILITY OF NOTICE AND COMMENT

22 RULEMAKING AND OTHER REQUIREMENTS.—The re23 quirements of subsection (b) shall apply with respect to 

24 orders issued under this section instead of the requireVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 ments of subchapter II of chapter 5 of title 5, United 

2 States Code. 

3 ‘‘(p) DEFINITIONS.—In this section: 

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

5 a drug not subject to the requirements of section 

6 503(b)(1). 

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

8 marketing, manufacturing, or processing a drug 

9 that— 

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

11 and 

12 ‘‘(B) is or will be subject to an administra13 tive order of the Food and Drug Administra14 tion. 

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

16 or group of persons marketing, manufacturing, proc17 essing, or developing a drug.’’. 

18 SEC. 102. MISBRANDING. 

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

20 Act (21 U.S.C. 352) is amended by inserting after para21 graph (dd) the following: 

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

23 to section 505G, not the subject of an application ap24 proved under section 505 or an exemption under section 


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1 505(i), and does not comply with the requirements under 

2 section 505G. 

3 ‘‘(ff) If it is a drug and it was manufactured, pre4 pared, propagated, compounded, or processed in a facility 

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

6 744O.’’. 

7 SEC. 103. DRUGS EXCLUDED FROM THE OVER-THE8 COUNTER DRUG REVIEW. 

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

10 amendments made by this Act) shall apply to any non11 prescription drug which was excluded by the Food and 

12 Drug Administration from the Over-the-Counter Drug Re13 view in accordance with the statement set out at page 

14 9466 of volume 37 of the Federal Register, published on 

15 May 11, 1972. 

16 (b) RULE OF CONSTRUCTION.—Nothing in this sec17 tion shall be construed to preclude or limit the applica18 bility of any other provision of the Federal Food, Drug, 

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

20 SEC. 104. TREATMENT OF SUNSCREEN INNOVATION ACT. 

21 (a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC22 TIVE INGREDIENTS.— 

23 (1) APPLICABILITY OF SECTION 505G FOR

24 PENDING SUBMISSIONS.— 


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1 (A) IN GENERAL.—A sponsor of a non2 prescription sunscreen active ingredient or com3 bination of nonprescription sunscreen active in4 gredients that, as of the date of enactment of 

5 this Act, is subject to a proposed sunscreen 

6 order under section 586C of the Federal Food, 

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

8 may elect, by means of giving written notifica9 tion to the Secretary of Health and Human 

10 Services within 90 calendar days of the enact11 ment of this Act, to transition into the review 

12 of such ingredient or combination of ingredients 

13 pursuant to the process set out in section 505G 

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

15 as added by section 101 of this Act. 

16 (B) ELECTION EXERCISED.—Upon receipt 

17 by the Secretary of Health and Human Services 

18 of a timely notification under subparagraph 

19 (A)— 

20 (i) the proposed sunscreen order in21 volved is deemed to be a request for an 

22 order under subsection (b) of section 505G 

23 of the Federal Food, Drug, and Cosmetic 

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

25 and 


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1 (ii) such order is deemed to have been 

2 accepted for filing under subsection 

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

4 (C) ELECTION NOT EXERCISED.—A spon5 sor of a nonprescription sunscreen active ingre6 dient or combination of nonprescription sun7 screen active ingredients described in subpara8 graph (A) that does not elect for such ingre9 dient or combination of ingredients to be re10 viewed under section 505G of the Federal Food, 

11 Drug, and Cosmetic Act, as added by section 

12 101 of this Act, shall continue to have such in13 gredient or combination of ingredients reviewed 

14 in accordance with section 586C of the Federal 

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

16 360fff–3) and may not subsequently elect to 

17 transition into the review of such ingredient or 

18 combination of ingredients pursuant to the 

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

20 added by section 101 of this Act. 

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

22 terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac23 tive ingredient’’, and ‘‘proposed sunscreen order’’ 

24 have the meanings given to those terms in section 


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1 586 of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 360fff). 

3 (b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 

4 (1) FINAL SUNSCREEN ORDERS.—Paragraph 

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

6 and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend7 ed to read as follows: 

8 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC9 TION 505G.—A final sunscreen order shall be deemed 

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

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

12 586C(b) of the Federal Food, Drug, and Cosmetic 

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

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

15 and inserting the following: 

16 ‘‘(A) IN GENERAL.—A sponsor may re17 quest’’; and 

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

19 ‘‘(B) CONFIDENTIAL MEETINGS.—A spon20 sor may request one or more confidential meet21 ings with respect to a proposed sunscreen order, 

22 including a letter deemed to be a proposed sun23 screen order under paragraph (3), to discuss 

24 matters involving confidential commercial infor25 mation or trade secrets. The Secretary shall 


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1 convene a confidential meeting with such spon2 sor in a reasonable time period. If a sponsor re3 quests more than one confidential meeting for 

4 the same proposed sunscreen order, the Sec5 retary may refuse to grant an additional con6 fidential meeting request if the Secretary deter7 mines that such additional confidential meeting 

8 is not reasonably necessary for the sponsor to 

9 advance its proposed sunscreen order, or if the 

10 request for a confidential meeting fails to in11 clude sufficient information upon which to base 

12 a substantive discussion. The Secretary shall 

13 publish a post-meeting summary of each con14 fidential meeting under this subparagraph that 

15 does not disclose confidential commercial infor16 mation or trade secrets.’’. 

17 (3) SUNSET PROVISION.—Subchapter I of chap18 ter V of the Federal Food, Drug, and Cosmetic Act 

19 (21 U.S.C. 360fff et seq.) is amended by adding at 

20 the end the following: 

21 ‘‘SEC. 586H. SUNSET. 

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

23 of fiscal year 2022.’’. 

24 (c) TREATMENT OF NON-SUNSCREEN TIME AND EX25 TENT APPLICATIONS.— 


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

2 section 586F of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 360fff–6) that was submitted 

4 to the Secretary of Health and Human Services pur5 suant to section 330.14 of title 21, Code of Federal 

6 Regulations, as such provisions were in effect imme7 diately prior to the date of enactment date of this 

8 Act, shall be extinguished as of such date of enact9 ment, subject to paragraph (2). 

10 (2) ORDER REQUEST.—Nothing in paragraph 

11 (1) precludes the submission of an order request 

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

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

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

15 an application extinguished under paragraph (1). 

16 SEC. 105. ANNUAL UPDATE TO CONGRESS ON APPRO17 PRIATE PEDIATRIC INDICATION FOR CER18 TAIN OTC COUGH AND COLD DRUGS. 

19 (a) IN GENERAL.—Subject to subsection (c), the Sec20 retary of Health and Human Services shall, beginning not 

21 later than one year after the date of enactment of this 

22 Act, annually submit to the Committee on Energy and 

23 Commerce of the House of Representatives and the Com24 mittee on Health, Education, Labor, and Pensions of the 


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1 Senate a letter describing the progress of the Food and 

2 Drug Administration— 

3 (1) in evaluating the cough and cold monograph 

4 described in subsection (b) with respect to children 

5 under age 6; and 

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

7 monograph to address such children through the 

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

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

10 101 of this Act. 

11 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

12 The cough and cold monograph described in this sub13 section consists of the conditions under which nonprescrip14 tion drugs containing antitussive, expectorant, nasal de15 congestant, or antihistamine active ingredients (or com16 binations thereof) are generally recognized as safe and ef17 fective, as specified in part 341 of title 21, Code of Federal 

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

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

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

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

22 of this Act. 

23 (c) DURATION OF AUTHORITY.—The requirement 

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

25 letter submitted by the Secretary of Health and Human 


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1 Services pursuant to such subsection in which the Sec2 retary indicates that the Food and Drug Administration 

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

4 as applicable, the cough and cold monograph as described 

5 in subsection (a)(2). 

6 TITLE II—USER FEES 

7 SEC. 201. SHORT TITLE; FINDING. 

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

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

10 (b) FINDING.—The Congress finds that the fees au11 thorized by the amendments made in this title will be dedi12 cated to OTC monograph drug activities, as set forth in 

13 the goals identified for purposes of part 10 of subchapter 

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

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

16 Human Services to the Chairman of the Committee on 

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

18 the Chairman of the Committee on Energy and Commerce 

19 of the House of Representatives, as set forth in the Con20 gressional Record. 

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

22 Subchapter C of chapter VII of the Federal Food, 

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

24 amended by inserting after part 9 the following: 


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1 ‘‘PART 10—FEES RELATING TO OVER-THE2 COUNTER DRUGS 

3 ‘‘SEC. 744N. DEFINITIONS. 

4 ‘‘In this part: 

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

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

9 the power to control, the other business entity; 

10 or 

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

12 to control, both of the business entities. 

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

16 facility nor any affiliate of such owner or facility 

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

19 in the United States. 

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

21 OTC monograph drug activities’ means the expenses 

22 in connection with OTC monograph drug activities 

23 for— 

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

25 and Drug Administration, contractors of the 

26 Food and Drug Administration, advisory comVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 mittees, and costs related to such officers, em2 ployees, and committees and costs related to 

3 contracts with such contractors; 

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

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

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

8 repair of facilities and acquisition, maintenance, 

9 and repair of fixtures, furniture, scientific 

10 equipment, and other necessary materials and 

11 supplies; and 

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

13 and accounting for resources allocated for OTC 

14 monograph drug activities. 

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

16 the unique number automatically generated by Food 

17 and Drug Administration’s Field Accomplishments 

18 and Compliance Tracking System (FACTS) (or any 

19 successor system). 

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

21 nonprescription drug without an approved new drug 

22 application which is governed by the provisions of 

23 section 505G. 

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

25 means activities of the Secretary associated with 


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1 OTC monograph drugs and inspection of facilities 

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

4 ‘‘(A) The activities necessary for review 

5 and evaluation of OTC monographs and OTC 

6 monograph order requests, including— 

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

10 ‘‘(ii) orders affecting status regarding 

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

13 combination of ingredients under specified 

14 conditions of use; 

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

17 intraagency collaboration; 

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

20 drugs; 

21 ‘‘(v) development of product standards 

22 for products subject to review and evalua23 tion; 

24 ‘‘(vi) meetings referred to in section 

25 505G(i); 


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1 ‘‘(vii) review of labeling prior to 

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

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

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

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

10 monograph drugs. 

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

12 monograph drugs, including— 

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

15 drugs, including adverse event reports; 

16 ‘‘(ii) developing and using improved 

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

19 and 

20 ‘‘(iii) developing and using improved 

21 analytical tools to assess potential safety 

22 risks, including access to external data23 bases. 

24 ‘‘(E) Other activities necessary for imple25 mentation of section 505G. 


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

2 means a request for an order submitted under sec3 tion 505G(b)(6). 

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

5 request’ means any OTC monograph order request 

6 not determined to be a Tier 2 OTC monograph 

7 order request. 

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

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

10 an OTC monograph order request for— 

11 ‘‘(i) the reordering of existing information 

12 in the drug facts label of an OTC monograph 

13 drug; 

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

15 other information section of the drug facts label 

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

18 Regulations (or any successor regulations); 

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

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

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

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

25 within a particular finalized monograph; 


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1 ‘‘(v) a change to ingredient nomenclature 

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

4 ‘‘(vi) addition of an interchangeable term 

5 in accordance with section 330.1 of title 21, 

6 Code of Federal Regulations (or any successor 

7 regulations). 

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

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

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

18 entity that— 

19 ‘‘(i) is— 

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

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

25 monograph drug; 


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

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

5 drugs; and 

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

7 entity whose only manufacturing or processing 

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

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

11 separate buildings or locations within close proximity 

12 are considered to be at one geographic location or 

13 address if the activities conducted in such buildings 

14 or locations are— 

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

16 enterprise; 

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

18 local management; and 

19 ‘‘(iii) under a single FDA establishment 

20 identifier and capable of being inspected by the 

21 Food and Drug Administration during a single 

22 inspection. 

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

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

25 under multiple management, the business or other 


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1 entity is deemed to constitute multiple facilities, one 

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

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

6 proposed OTC monograph order request. 

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

8 a person. 

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

10 the meanings given such terms in section 505G. 

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

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

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

16 ‘‘(1) FACILITY FEE.— 

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

18 owns a facility identified as an OTC monograph 

19 drug facility on December 31 of the fiscal year 

20 or at any time during the preceding 12-month 

21 period shall be assessed an annual fee for each 

22 such facility as determined under subsection 

23 (c). 

24 ‘‘(B) EXCEPTIONS.— 


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

2 subparagraph (A) if the identified OTC 

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

5 prior to the date specified in subparagraph 

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

7 reflect such change under the requirements 

8 for drug establishment registration set 

9 forth in section 510. 

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

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

13 for an OTC monograph drug facility that 

14 is not a contract manufacturing organiza15 tion facility. 

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

19 ‘‘(D) DUE DATE.— 

20 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

21 fiscal year 2019, the facility fees required 

22 under subparagraph (A) shall be due 45 

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

25 subsection (c)(4)(A). 


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1 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

2 For each fiscal year after fiscal year 2019, 

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

5 ‘‘(I) the first business day of 

6 June of such year; or 

7 ‘‘(II) the first business day after 

8 the enactment of an appropriations 

9 Act providing for the collection and 

10 obligation of fees under this section 

11 for such year. 

12 ‘‘(2) OTC MONOGRAPH ORDER REQUEST

13 FEE.— 

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

16 subject to a fee for an OTC monograph order 

17 request. The amount of such fee shall be— 

18 ‘‘(i) for a Tier 1 OTC monograph 

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

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

22 ‘‘(ii) for a Tier 2 OTC monograph 

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

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


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1 ‘‘(B) DUE DATE.—The OTC monograph 

2 order request fees required under subparagraph 

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

4 the OTC monograph order request. 

5 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

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

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

9 the Secretary finds that the OTC monograph 

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

12 that would add to or strengthen— 

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

14 precaution; 

15 ‘‘(ii) a statement about risk associated 

16 with misuse or abuse; or 

17 ‘‘(iii) an instruction about dosage and 

18 administration that is intended to increase 

19 the safe use of the OTC monograph drug. 

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

21 IS RECATEGORIZED AS A TIER 2 OTC MONO22 GRAPH ORDER REQUEST.—If the Secretary de23 termines that an OTC monograph request ini24 tially characterized as Tier 1 shall be re-charac25 terized as a Tier 2 OTC monograph order reVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 quest, and the requestor has paid a Tier 1 fee 

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

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

6 (A)(ii), respectively. 

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

8 REFUSED FOR FILING OR WITHDRAWN BEFORE

9 FILING.—The Secretary shall refund 75 percent 

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

11 order request which is refused for filing. 

12 ‘‘(F) FEES FOR ORDER REQUESTS PRE13 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

14 BEFORE FILING.—An OTC monograph order 

15 request that was submitted but was refused for 

16 filing, or was withdrawn before being accepted 

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

18 fee under subparagraph (A) upon being resub19 mitted or filed over protest. 

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

21 WITHDRAWN.—If an order request is withdrawn 

22 after the order request was filed, the Secretary 

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

24 substantial work was performed on the order 

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1 retary shall have the sole discretion to refund a 

2 fee or a portion of the fee under this subpara3 graph. A determination by the Secretary con4 cerning a refund under this subparagraph shall 

5 not be reviewable. 

6 ‘‘(3) REFUNDS.— 

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

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

9 paragraph (2), the Secretary shall not refund 

10 any fee paid under paragraph (1) except as pro11 vided in subparagraph (B). 

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

13 qualify for the return of a fee claimed to have 

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

15 a person shall submit to the Secretary a written 

16 request justifying such return within 180 cal17 endar days after such fee was paid. 

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

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

20 Federal Register the amount of the fees under para21 graph (1) for such fiscal year. 

22 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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


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1 generate a total facility fee revenue amount equal to 

2 the sum of— 

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

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

5 ‘‘(B) the dollar amount equal to the oper6 ating reserve adjustment for the fiscal year, if 

7 applicable (as determined under subsection 

8 (c)(2)); and 

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

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

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

12 the fiscal years 2020 through 2023, fees under sub13 section (a)(1) shall be established to generate a total 

14 facility fee revenue amount equal to the sum of— 

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

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

17 ‘‘(B) the dollar amount equal to the infla18 tion adjustment for the fiscal year (as deter19 mined under subsection (c)(1)); 

20 ‘‘(C) the dollar amount equal to the oper21 ating reserve adjustment for the fiscal year, if 

22 applicable (as determined under subsection 

23 (c)(2)); 

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

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


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1 ‘‘(E) additional dollar amounts for each 

2 fiscal year as follows: 

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

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

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

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

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

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

9 of the annual base revenue for a fiscal year shall 

10 be— 

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

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

13 the dollar amount of the total revenue amount 

14 established under this subsection for the pre15 vious fiscal year, not including any adjustments 

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

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

18 ‘‘(1) INFLATION ADJUSTMENT.— 

19 ‘‘(A) IN GENERAL.—For purposes of sub20 section (b)(2)(B), the dollar amount of the in21 flation adjustment to the annual base revenue 

22 for fiscal year 2020 and each subsequent fiscal 

23 year shall be equal to the product of— 

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

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


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1 ‘‘(ii) the inflation adjustment percent2 age under subparagraph (C). 

3 ‘‘(B) OTC MONOGRAPH ORDER REQUEST

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

5 dollar amount of the inflation adjustment to the 

6 fee for OTC monograph order requests for fis7 cal year 2020 and each subsequent fiscal year 

8 shall be equal to the product of— 

9 ‘‘(i) the applicable fee under sub10 section (a)(2) for the preceding fiscal year; 

11 and 

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

14 ‘‘(C) INFLATION ADJUSTMENT PERCENT15 AGE.—The inflation adjustment percentage 

16 under this subparagraph for a fiscal year is 

17 equal to— 

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

19 2021, the average annual percent change 

20 that occurred in the Consumer Price Index 

21 for urban consumers (Washington-Balti22 more, DC–MD–VA–WV; Not Seasonally 

23 Adjusted; All items; Annual Index) for the 

24 first 3 years of the preceding 4 years of 

25 available data; and 


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

2 2023, the sum of— 

3 ‘‘(I) the average annual percent 

4 change in the cost, per full-time equiv5 alent position of the Food and Drug 

6 Administration, of all personnel com7 pensation and benefits paid with re8 spect to such positions for the first 3 

9 years of the preceding 4 fiscal years, 

10 multiplied by the proportion of per11 sonnel compensation and benefits 

12 costs to total costs of OTC mono13 graph drug activities for the first 3 

14 years of the preceding 4 fiscal years; 

15 and 

16 ‘‘(II) the average annual percent 

17 change that occurred in the Consumer 

18 Price Index for urban consumers 

19 (Washington-Baltimore, DC–MD–VA– 

20 WV; Not Seasonally Adjusted; All 

21 items; Annual Index) for the first 3 

22 years of the preceding 4 years of 

23 available data multiplied by the pro24 portion of all costs other than per25 sonnel compensation and benefits 


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1 costs to total costs of OTC mono2 graph drug activities for the first 3 

3 years of the preceding 4 fiscal years. 

4 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

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

6 and subsequent fiscal years, for purposes of 

7 subsections (b)(1)(B) and (b)(2)(C), the Sec8 retary may, in addition to adjustments under 

9 paragraph (1), further increase the fee revenue 

10 and fees if such an adjustment is necessary to 

11 provide operating reserves of carryover user 

12 fees for OTC monograph drug activities for not 

13 more than the number of weeks specified in 

14 subparagraph (B). 

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

16 weeks specified in this subparagraph is— 

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

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

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

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

21 and 

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

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

24 carryover balances for such process in excess of 

25 10 weeks of the operating reserves referred to 


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1 in subparagraph (A), the Secretary shall de2 crease the fee revenue and fees referred to in 

3 such subparagraph to provide for not more than 

4 10 weeks of such operating reserves. 

5 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

6 an adjustment under this paragraph is made, 

7 the rationale for the amount of the increase or 

8 decrease (as applicable) in fee revenue and fees 

9 shall be contained in the annual Federal Reg10 ister notice under paragraph (4) establishing 

11 fee revenue and fees for the fiscal year involved. 

12 ‘‘(3) ADDITIONAL DIRECT COST ADJUST13 MENT.—The Secretary shall, in addition to adjust14 ments under paragraphs (1) and (2), further in15 crease the fee revenue and fees for purposes of sub16 section (b)(2)(D) by an amount equal to— 

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

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

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

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

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

22 ‘‘(4) ANNUAL FEE SETTING.— 

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

24 shall, not later than January 31, 2019— 


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1 ‘‘(i) establish OTC monograph drug 

2 facility fees for fiscal year 2019 under sub3 section (a), based on the revenue amount 

4 for such year under subsection (b) and the 

5 adjustments provided under this sub6 section; and 

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

8 and OTC monograph order requests in the 

9 Federal Register. 

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

11 Secretary shall, not later than January 31 of 

12 each fiscal year that begins after September 30, 

13 2019, establish for each such fiscal year, based 

14 on the revenue amounts under subsection (b) 

15 and the adjustments provided under this sub16 section— 

17 ‘‘(i) OTC monograph drug facility fees 

18 under subsection (a)(1); 

19 ‘‘(ii) OTC monograph order request 

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

21 ‘‘(iii) publish such fee revenue 

22 amounts, facility fees, and OTC mono23 graph order request fees in the Federal 

24 Register. 


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

2 that owns an OTC monograph drug facility shall submit 

3 to the Secretary the information required under this sub4 section each year. Such information shall, for each fiscal 

5 year— 

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

7 for drug establishment registration set forth in sec8 tion 510; and 

9 ‘‘(2) include for each such facility, at a min10 imum, identification of the facility’s business oper11 ation as that of an OTC monograph drug facility. 

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

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

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

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

16 of the due date as specified in subparagraph 

17 (D) of such subsection shall result in the fol18 lowing: 

19 ‘‘(i) The Secretary shall place the fa20 cility on a publicly available arrears list. 

21 ‘‘(ii) All OTC monograph drugs man22 ufactured in such a facility or containing 

23 an ingredient manufactured in such a facil24 ity shall be deemed misbranded under sec25 tion 502(a). 


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

2 penalties under this paragraph shall apply until 

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

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

5 order request submitted by a person subject to fees 

6 under subsection (a) shall be considered incomplete 

7 and shall not be accepted for filing by the Secretary 

8 until all fees owed by such person under this section 

9 have been paid. 

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

11 under this section shall be considered ineligible for 

12 OTC monograph drug meetings until all such fees 

13 owed by such person have been paid. 

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

15 ‘‘(1) IN GENERAL.—Subject to paragraph 

16 (2)(D), fees authorized under subsection (a) shall be 

17 collected and available for obligation only to the ex18 tent and in the amount provided in advance in ap19 propriations Acts. Such fees are authorized to re20 main available until expended. Such sums as may be 

21 necessary may be transferred from the Food and 

22 Drug Administration salaries and expenses appro23 priation account without fiscal year limitation to 

24 such appropriation account for salaries and expenses 

25 with such fiscal year limitation. The sums transVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00079 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 ferred shall be available solely for OTC monograph 

2 drug activities. 

3 ‘‘(2) COLLECTIONS AND APPROPRIATION

4 ACTS.— 

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graphs (C) and (D), the fees authorized by this 

7 section shall be collected and available in each 

8 fiscal year in an amount not to exceed the 

9 amount specified in appropriation Acts, or oth10 erwise made available for obligation, for such 

11 fiscal year. 

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

13 The fees authorized by this section shall be 

14 available to defray increases in the costs of the 

15 resources allocated for OTC monograph drug 

16 activities (including increases in such costs for 

17 an additional number of full-time equivalent po18 sitions in the Department of Health and 

19 Human Services to be engaged in such activi20 ties), only if the Secretary allocates for such 

21 purpose an amount for such fiscal year (exclud22 ing amounts from fees collected under this sec23 tion) no less than $12,000,000, multiplied by 

24 the adjustment factor applicable to the fiscal 

25 year involved under subsection (c)(1). 


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

2 be considered to have met the requirements of 

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

4 funded by appropriations and allocated for OTC 

5 monograph drug activities are not more than 15 

6 percent below the level specified in such sub7 paragraph. 

8 ‘‘(D) FEE COLLECTION DURING FIRST

9 PROGRAM YEAR.—Until the date of the enact10 ment of an Act making appropriations and pro11 viding for the collection and obligation of fees 

12 under this section through September 30, 2019, 

13 for the salaries and expenses account of the 

14 Food and Drug Administration, fees authorized 

15 by this section for fiscal year 2019 may be col16 lected and shall be credited to such account and 

17 remain available until expended. 

18 ‘‘(E) PROVISION FOR EARLY PAYMENTS IN

19 SUBSEQUENT YEARS.—Payment of fees author20 ized under this section for a fiscal year (after 

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

22 fees, may be accepted by the Secretary in ac23 cordance with authority provided in advance in 

24 a prior year appropriations Act. 


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

2 For each of the fiscal years 2019 through 2023, 

3 there is authorized to be appropriated for fees under 

4 this section an amount equal to the total amount of 

5 fees assessed for such fiscal year under this section. 

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

7 where the Secretary does not receive payment of a fee as8 sessed under subsection (a) within 30 calendar days after 

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

10 States Government subject to subchapter II of chapter 37 

11 of title 31, United States Code. 

12 ‘‘(h) CONSTRUCTION.—This section may not be con13 strued to require that the number of full-time equivalent 

14 positions in the Department of Health and Human Serv15 ices, for officers, employers, and advisory committees not 

16 engaged in OTC monograph drug activities, be reduced 

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

18 committees so engaged. 

19 ‘‘SEC. 744P. REAUTHORIZATION; REPORTING REQUIRE20 MENTS. 

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

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

23 end of each fiscal year thereafter for which fees are col24 lected under this part, the Secretary shall prepare and 

25 submit to the Committee on Energy and Commerce of the 


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1 House of Representatives and the Committee on Health, 

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

3 concerning the progress of the Food and Drug Adminis4 tration in achieving the goals identified in the letters de5 scribed in section 201(b) of the Over-the-Counter Mono6 graph Safety, Innovation, and Reform Act of 2018 during 

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

8 Drug Administration for meeting such goals. 

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

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

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

12 the Secretary shall prepare and submit to the Committee 

13 on Energy and Commerce of the House of Representatives 

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

15 Pensions of the Senate a report on the implementation 

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

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

18 collected for such fiscal year. 

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

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

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

22 and Drug Administration. 

23 ‘‘(d) REAUTHORIZATION.— 

24 ‘‘(1) CONSULTATION.—In developing rec25 ommendations to present to the Congress with reVerDate Sep 11 2014 23:08 Apr 03, 2018 Jkt 079200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6201 E:\BILLS\H5333.IH H5333

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1 spect to the goals described in subsection (a), and 

2 plans for meeting the goals, for OTC monograph 

3 drug activities for the first 5 fiscal years after fiscal 

4 year 2023, and for the reauthorization of this part 

5 for such fiscal years, the Secretary shall consult 

6 with— 

7 ‘‘(A) the Committee on Energy and Com8 merce of the House of Representatives; 

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

10 Labor, and Pensions of the Senate; 

11 ‘‘(C) scientific and academic experts; 

12 ‘‘(D) health care professionals; 

13 ‘‘(E) representatives of patient and con14 sumer advocacy groups; and 

15 ‘‘(F) the regulated industry. 

16 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA17 TIONS.—After negotiations with the regulated indus18 try, the Secretary shall— 

19 ‘‘(A) present the recommendations devel20 oped under paragraph (1) to the congressional 

21 committees specified in such paragraph; 

22 ‘‘(B) publish such recommendations in the 

23 Federal Register; 


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

2 days for the public to provide written comments 

3 on such recommendations; 

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

5 may present its views on such recommenda6 tions; and 

7 ‘‘(E) after consideration of such public 

8 views and comments, revise such recommenda9 tions as necessary. 

10 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

11 Not later than January 15, 2023, the Secretary 

12 shall transmit to the Congress the revised rec13 ommendations under paragraph (2), a summary of 

14 the views and comments received under such para15 graph, and any changes made to the recommenda16 tions in response to such views and comments.’’. 

Æ 


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