I 

116TH CONGRESS 

1ST SESSION H. R. 3443 

To clarify the regulatory framework with respect to certain nonprescription 

drugs that are marketed without an approved drug application, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 24, 2019 

Ms. DEGETTE (for herself, Mr. LATTA, Mrs. DINGELL, and Mr. GUTHRIE) 

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

A BILL 

To clarify the regulatory framework with respect to certain 

nonprescription drugs that are marketed without an approved 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Over-the-Counter Monograph Safety, Innovation, and 

6 Reform Act of 2019’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 


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TITLE I—OTC DRUG REVIEW 

Sec. 1001. Regulation of certain nonprescription drugs that are marketed without an approved drug application. 

Sec. 1002. Misbranding. 

Sec. 1003. Drugs excluded from the over-the-counter drug review. 

Sec. 1004. Treatment of Sunscreen Innovation Act. 

Sec. 1005. Annual update to Congress on appropriate pediatric indication for 

certain OTC cough and cold drugs. 

Sec. 1006. Technical corrections. 

TITLE II—USER FEES 

Sec. 2001. Short title; finding. 

Sec. 2002. Fees relating to over-the-counter drugs. 

1 TITLE I—OTC DRUG REVIEW 

2 SEC. 1001. REGULATION OF CERTAIN NONPRESCRIPTION 

3 DRUGS THAT ARE MARKETED WITHOUT AN 

4 APPROVED 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 DRUG APPLICATION. 

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

13 drugs marketed without an approved drug application 

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

15 section, shall be treated in accordance with this sub16 section. 

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

18 CATEGORY I DRUGS SUBJECT TO A TENTATIVE

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1 erally recognized as safe and effective under section 

2 201(p)(1), not a new drug under section 201(p), and 

3 not subject to section 503(b)(1), if— 

4 ‘‘(A) the drug is— 

5 ‘‘(i) in conformity with the require6 ments for nonprescription use of a final 

7 monograph issued under part 330 of title 

8 21, Code of Federal Regulations (except as 

9 provided in paragraph (2)), the general re10 quirements for nonprescription drugs, and 

11 conditions or requirements under sub12 sections (b), (c), and (k); and 

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

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

15 of a minor change in the drug, in con16 formity with an order issued under sub17 section (c), in a dosage form that, imme18 diately prior to the date of the enactment 

19 of this section, has been used to a material 

20 extent and for a material time under sec21 tion 201(p)(2); or 

22 ‘‘(B) the drug is— 

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

24 and effectiveness under a tentative final 

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1 cable proposal or determination issued 

2 under part 330 of title 21, Code of Federal 

3 Regulations; 

4 ‘‘(ii) in conformity with the proposed 

5 requirements for nonprescription use of 

6 such tentative final monograph, any appli7 cable subsequent determination by the Sec8 retary, the general requirements for non9 prescription drugs, and conditions or re10 quirements under subsections (b), (c), and 

11 (k); and 

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

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

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

18 of this section, has been used to a material 

19 extent and for a material time under sec20 tion 201(p)(2). 

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

22 With respect to sunscreen drugs subject to this sec23 tion, the applicable requirements in terms of con24 formity with a final monograph, for purposes of 

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1 fied in part 352 of title 21, Code of Federal Regula2 tions, as published on May 21, 1999, beginning on 

3 page 27687 of volume 64 of the Federal Register, 

4 except that the applicable requirements governing ef5 fectiveness and labeling shall be those specified in 

6 section 201.327 of title 21, Code of Federal Regula7 tions. 

8 ‘‘(3) CATEGORY III DRUGS SUBJECT TO A TEN9 TATIVE FINAL MONOGRAPH; CATEGORY I DRUGS

10 SUBJECT TO PROPOSED MONOGRAPH OR ADVANCE

11 NOTICE OF PROPOSED RULEMAKING.—A drug that 

12 is not described in paragraph (1), (2), or (4) is not 

13 required to be the subject of an application approved 

14 under section 505, and is not subject to section 

15 503(b)(1), if— 

16 ‘‘(A) the drug is— 

17 ‘‘(i) classified in category III for safe18 ty or effectiveness in the preamble of a 

19 proposed rule establishing a tentative final 

20 monograph that is the most recently appli21 cable proposal or determination for such 

22 drug issued under part 330 of title 21, 

23 Code of Federal Regulations; 

24 ‘‘(ii) in conformity with— 


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1 ‘‘(I) the conditions of use, includ2 ing indication and dosage strength, if 

3 any, described for such category III 

4 drug in such preamble or in an appli5 cable subsequent proposed rule; 

6 ‘‘(II) the proposed requirements 

7 for drugs classified in such tentative 

8 final monograph in category I in the 

9 most recently proposed rule estab10 lishing requirements related to such 

11 tentative final monograph and in any 

12 final rule establishing requirements 

13 that are applicable to the drug; and 

14 ‘‘(III) the general requirements 

15 for nonprescription drugs and condi16 tions or requirements under sub17 section (b) or (k); and 

18 ‘‘(iii) in a dosage form that, imme19 diately prior to the date of the enactment 

20 of this section, had been used to a material 

21 extent and for a material time under sec22 tion 201(p)(2); or 

23 ‘‘(B) the drug is— 

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

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1 graph or advance notice of proposed rule2 making that is the most recently applicable 

3 proposal or determination for such drug 

4 issued under part 330 of title 21, Code of 

5 Federal Regulations; 

6 ‘‘(ii) in conformity with the require7 ments for nonprescription use of such pro8 posed monograph or advance notice of pro9 posed rulemaking, any applicable subse10 quent determination by the Secretary, the 

11 general requirements for nonprescription 

12 drugs, and conditions or requirements 

13 under subsection (b) or (k); and 

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

16 of this section, has been used to a material 

17 extent and for a material time under sec18 tion 201(p)(2). 

19 ‘‘(4) CATEGORY II DRUGS DEEMED NEW

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

21 safety or effectiveness under a tentative final mono22 graph or that is subject to a determination to be not 

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1 eral Regulations, shall be deemed to be a new drug 

2 under section 201(p), misbranded under section 

3 502(ee), and subject to the requirement for an ap4 proved new drug application under section 505 be5 ginning on the day that is 180 calendar days after 

6 the date of the enactment of this section, unless, be7 fore such day, the Secretary determines that it is in 

8 the interest of public health to extend the period 

9 during which the drug may be marketed without 

10 such an approved new drug application. 

11 ‘‘(5) DRUGS NOT GRASE DEEMED NEW

12 DRUGS.—A drug that the Secretary has determined 

13 not to be generally recognized as safe and effective 

14 under section 201(p)(1) under a final determination 

15 issued under part 330 of title 21, Code of Federal 

16 Regulations, shall be deemed to be a new drug under 

17 section 201(p), misbranded under section 502(ee), 

18 and subject to the requirement for an approved new 

19 drug application 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 under section 201(p) and 

23 misbranded under section 502(ee) if the drug— 

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

25 and 


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

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

3 ‘‘(b) ADMINISTRATIVE ORDERS.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) DETERMINATION.—The Secretary 

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

7 request of one or more requestors, issue an ad8 ministrative order determining whether there 

9 are conditions under which a specific drug, a 

10 class of drugs, or a combination of drugs, is de11 termined to be— 

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

13 and 

14 ‘‘(ii) generally recognized as safe and 

15 effective under section 201(p)(1). 

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

17 drugs shall be deemed to not require approval 

18 under section 505 if such drug or combination 

19 of drugs— 

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

21 meet the conditions specified in clauses (i) 

22 and (ii) of subparagraph (A); 

23 ‘‘(ii) is marketed in conformity with 

24 an administrative order under this sub25 section; 


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1 ‘‘(iii) meets the general requirements 

2 for nonprescription drugs; and 

3 ‘‘(iv) meets the requirements under 

4 subsections (c) and (k). 

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

6 that a drug is not generally recognized as safe 

7 and effective under section 201(p)(1) if— 

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

9 is not generally recognized as safe and ef10 fective under section 201(p)(1); or 

11 ‘‘(ii) the evidence is inadequate to 

12 show that the drug is generally recognized 

13 as safe and effective under section 

14 201(p)(1). 

15 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY

16 THE SECRETARY.— 

17 ‘‘(A) IN GENERAL.—In issuing an adminis18 trative order under paragraph (1) upon the 

19 Secretary’s initiative, the Secretary shall— 

20 ‘‘(i) make reasonable efforts to notify 

21 informally, not later than 2 business days 

22 before the issuance of the proposed order, 

23 the sponsors of drugs who have a listing in 

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


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1 combination of drugs that will be subject 

2 to the administrative order; 

3 ‘‘(ii) after any such reasonable efforts 

4 of notification— 

5 ‘‘(I) issue a proposed administra6 tive order by publishing it on the 

7 website of the Food and Drug Admin8 istration and include in such order the 

9 reasons for the issuance of such order; 

10 and 

11 ‘‘(II) publish a notice of avail12 ability of such proposed order in the 

13 Federal Register; 

14 ‘‘(iii) except as provided in subpara15 graph (B), provide for a public comment 

16 period with respect to such proposed order 

17 of not less than 45 calendar days; and 

18 ‘‘(iv) if, after completion of the pro19 ceedings specified in clauses (i) through 

20 (iii), the Secretary determines that it is ap21 propriate to issue a final administrative 

22 order— 

23 ‘‘(I) issue the final administrative 

24 order, together with a detailed state25 ment of reasons, which order shall not 


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1 take effect until the time for request2 ing judicial review under paragraph 

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

4 ‘‘(II) publish a notice of such 

5 final administrative order in the Fed6 eral Register; 

7 ‘‘(III) afford requestors of drugs 

8 that will be subject to such order the 

9 opportunity for formal dispute resolu10 tion up to the level of the Director of 

11 the Center for Drug Evaluation and 

12 Research, which initially must be re13 quested within 45 calendar days of 

14 the issuance of the order, and, for 

15 subsequent levels of appeal, within 30 

16 calendar days of the prior decision; 

17 and 

18 ‘‘(IV) except with respect to 

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

20 upon completion of the formal dispute 

21 resolution procedure, inform the per22 sons which sought such dispute reso23 lution of their right to request a hear24 ing. 


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

3 Secretary’s initiative proposing to determine 

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

5 generally recognized as safe and effective under 

6 section 201(p)(1), the Secretary shall follow the 

7 procedures in subparagraph (A), except that— 

8 ‘‘(i) the proposed order shall include 

9 notice of— 

10 ‘‘(I) the general categories of 

11 data the Secretary has determined 

12 necessary to establish that the drug is 

13 generally recognized as safe and effec14 tive under section 201(p)(1); and 

15 ‘‘(II) the format for submissions 

16 by interested persons; 

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

18 public comment period of no less than 180 

19 calendar days with respect to such pro20 posed order, except when the Secretary de21 termines, for good cause, that a shorter pe22 riod is in the interest of public health; and 

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

24 such comment period shall include a cer25 tification that the person has submitted all 


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1 evidence created, obtained, or received by 

2 that person that is both within the cat3 egories of data identified in the proposed 

4 order and relevant to a determination as to 

5 whether the drug is generally recognized as 

6 safe and effective under section 201(p)(1). 

7 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

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

9 participated in each stage of formal dispute res10 olution under subclause (III) of paragraph 

11 (2)(A)(iv) of an administrative order with re12 spect to a drug may request a hearing con13 cerning a final administrative order issued 

14 under such paragraph with respect to such 

15 drug. If a hearing is sought, such person must 

16 submit a request for a hearing, which shall be 

17 based solely on information in the administra18 tive record, to the Secretary not later than 30 

19 calendar days after receiving notice of the final 

20 decision of the formal dispute resolution proce21 dure. 

22 ‘‘(B) NO HEARING REQUIRED WITH RE23 SPECT TO ORDERS RELATING TO CERTAIN

24 DRUGS.— 


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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall not be required to provide notice and 

3 an opportunity for a hearing pursuant to 

4 paragraph (2)(A)(iv) if the final adminis5 trative order involved relates to a drug— 

6 ‘‘(I) that is described in sub7 section (a)(3)(A); and 

8 ‘‘(II) with respect to which no 

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

11 such drug have been submitted to the 

12 administrative record since the 

13 issuance of the most recent tentative 

14 final monograph relating to such 

15 drug. 

16 ‘‘(ii) HUMAN DATA STUDIES AND

17 NON-HUMAN DATA DEFINED.—In this sub18 paragraph: 

19 ‘‘(I) The term ‘human data stud20 ies’ means clinical trials of safety or 

21 effectiveness (including actual use 

22 studies), pharmacokinetics studies, or 

23 bioavailability studies. 

24 ‘‘(II) The term ‘non-human data’ 

25 means data from testing other than 


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1 with human subjects which provides 

2 information concerning safety or ef3 fectiveness. 

4 ‘‘(C) HEARING PROCEDURES.— 

5 ‘‘(i) DENIAL OF REQUEST FOR HEAR6 ING.—If the Secretary determines that in7 formation submitted in a request for a 

8 hearing under subparagraph (A) with re9 spect to a final administrative order issued 

10 under paragraph (2)(A)(iv) does not iden11 tify the existence of a genuine and sub12 stantial question of material fact, the Sec13 retary may deny such request. In making 

14 such a determination, the Secretary may 

15 consider only information and data that 

16 are based on relevant and reliable scientific 

17 principles and methodologies. 

18 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

19 RELATED REQUESTS.—If more than one 

20 request for a hearing is submitted with re21 spect to the same administrative order 

22 under subparagraph (A), the Secretary 

23 may direct that a single hearing be con24 ducted in which all persons whose hearing 

25 requests were granted may participate. 


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

3 subparagraph (A) shall— 

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

6 ‘‘(II) not be an employee of the 

7 Center for Drug Evaluation and Re8 search; and 

9 ‘‘(III) not have been previously 

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

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

16 under subparagraph (A) shall have the 

17 right to present testimony, including testi18 mony of expert witnesses, and to cross-ex19 amine witnesses presented by other parties. 

20 Where appropriate, the presiding officer 

21 may require that cross-examination by par22 ties representing substantially the same in23 terests be consolidated to promote effi24 ciency and avoid duplication. 

25 ‘‘(v) FINAL DECISION.— 


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

3 (A), the presiding officer of the hear4 ing shall issue a decision containing 

5 findings of fact and conclusions of 

6 law. The decision of the presiding offi7 cer shall be final. 

8 ‘‘(II) The final decision may not 

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

13 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN14 ISTRATIVE ORDER.— 

15 ‘‘(i) IN GENERAL.—The procedures 

16 described in section 505(h) shall apply 

17 with respect to judicial review of final ad18 ministrative orders issued under this sub19 section in the same manner and to the 

20 same extent as such section applies to an 

21 order described in such section except that 

22 the judicial review shall be taken by filing 

23 in an appropriate district court of the 

24 United States in lieu of the appellate 

25 courts specified in such section. 


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1 ‘‘(ii) PERIOD TO SUBMIT A REQUEST

2 FOR JUDICIAL REVIEW.—A person eligible 

3 to request a hearing under this paragraph 

4 and seeking judicial review of a final ad5 ministrative order issued under this sub6 section shall file such request for judicial 

7 review not later than 60 calendar days 

8 after the latest of— 

9 ‘‘(I) the date on which notice of 

10 such order is published; 

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

12 with respect to such order is denied 

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

14 ‘‘(III) the date on which a final 

15 decision is made following a hearing 

16 under subparagraph (C)(v); or 

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

18 the date on which the time for re19 questing a hearing expires. 

20 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT

21 TO ADMINISTRATIVE ORDERS INITIATED BY THE

22 SECRETARY.— 

23 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

24 HEALTH.— 


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1 ‘‘(i) IN GENERAL.—In the case of a 

2 determination by the Secretary that a 

3 drug, class of drugs, or combination of 

4 drugs subject to this section poses an im5 minent hazard to the public health, the 

6 Secretary, after first making reasonable ef7 forts to notify, not later than 48 hours be8 fore issuance of such order under this sub9 paragraph, sponsors who have a listing in 

10 effect under section 510(j) for such drug 

11 or combination of drugs— 

12 ‘‘(I) may issue an interim final 

13 administrative order for such drug, 

14 class of drugs, or combination of 

15 drugs under paragraph (1), together 

16 with a detailed statement of the rea17 sons for such order; 

18 ‘‘(II) shall publish in the Federal 

19 Register a notice of availability of any 

20 such order; and 

21 ‘‘(III) shall provide for a public 

22 comment period of at least 45 cal23 endar days with respect to such in24 terim final order. 


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1 ‘‘(ii) NONDELEGATION.—The Sec2 retary may not delegate the authority to 

3 issue an interim final administrative order 

4 under this subparagraph. 

5 ‘‘(B) SAFETY LABELING CHANGES.— 

6 ‘‘(i) IN GENERAL.—In the case of a 

7 determination by the Secretary that a 

8 change in the labeling of a drug, class of 

9 drugs, or combination of drugs subject to 

10 this section is reasonably expected to miti11 gate a significant or unreasonable risk of 

12 a serious adverse event associated with use 

13 of the drug, the Secretary may— 

14 ‘‘(I) make reasonable efforts to 

15 notify informally, not later than 48 

16 hours before the issuance of the in17 terim final order, the sponsors of 

18 drugs who have a listing in effect 

19 under section 510(j) for such drug or 

20 combination of drugs; 

21 ‘‘(II) after reasonable efforts of 

22 notification, issue an interim final ad23 ministrative order in accordance with 

24 paragraph (1) to require such change, 


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1 together with a detailed statement of 

2 the reasons for such order; 

3 ‘‘(III) publish in the Federal 

4 Register a notice of availability of 

5 such order; and 

6 ‘‘(IV) provide for a public com7 ment period of at least 45 calendar 

8 days with respect to such interim final 

9 order. 

10 ‘‘(ii) CONTENT OF ORDER.—An in11 terim final order issued under this sub12 paragraph with respect to the labeling of a 

13 drug may provide for new warnings and 

14 other information required for safe use of 

15 the drug. 

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

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

18 date specified by the Secretary. 

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

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

21 the Secretary shall— 

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

23 with paragraph (1); 


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

2 such final administrative order in the Fed3 eral Register; and 

4 ‘‘(iii) afford sponsors of such drugs 

5 that will be subject to such an order the 

6 opportunity for formal dispute resolution 

7 up to the level of the Director of the Cen8 ter for Drug Evaluation and Research, 

9 which must initially be within 45 calendar 

10 days of the issuance of the order, and for 

11 subsequent levels of appeal, within 30 cal12 endar days of the prior decision. 

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

14 subject to a final order issued under subpara15 graph (D) and that participated in each stage 

16 of formal dispute resolution under clause (iii) of 

17 such subparagraph may request a hearing on 

18 such order. The provisions of subparagraphs 

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

20 paragraph (3)(C)(v)(II), shall apply with re21 spect to a hearing on such order in the same 

22 manner and to the same extent as such provi23 sions apply with respect to a hearing on an ad24 ministrative order issued under paragraph 

25 (2)(A)(iv). 


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1 ‘‘(F) TIMING.— 

2 ‘‘(i) FINAL ORDER AND HEARING.— 

3 The Secretary shall— 

4 ‘‘(I) not later than 6 months 

5 after the date on which the comment 

6 period closes under subparagraph (A) 

7 or (B), issue a final order in accord8 ance with paragraph (1); and 

9 ‘‘(II) not later than 12 months 

10 after the date on which such final 

11 order is issued, complete any hearing 

12 under subparagraph (E). 

13 ‘‘(ii) DISPUTE RESOLUTION RE14 QUEST.—The Secretary shall specify in an 

15 interim final order issued under subpara16 graph (A) or (B) such shorter periods for 

17 requesting dispute resolution under sub18 paragraph (D)(iii) as are necessary to 

19 meet the requirements of this subpara20 graph. 

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

22 issued pursuant to subparagraph (F) shall be 

23 subject to judicial review in accordance with 

24 paragraph (3)(D). 


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1 ‘‘(5) ADMINISTRATIVE ORDER INITIATED AT

2 THE REQUEST OF A REQUESTOR.— 

3 ‘‘(A) IN GENERAL.—In issuing an adminis4 trative order under paragraph (1) at the re5 quest of a requestor with respect to certain 

6 drugs, classes of drugs, or combinations of 

7 drugs— 

8 ‘‘(i) the Secretary shall, after receiv9 ing a request under this subparagraph, de10 termine whether the request is sufficiently 

11 complete and formatted to permit a sub12 stantive review; 

13 ‘‘(ii) if the Secretary determines that 

14 the request is sufficiently complete and for15 matted to permit a substantive review, the 

16 Secretary shall— 

17 ‘‘(I) file the request; and 

18 ‘‘(II) initiate proceedings with re19 spect to issuing an administrative 

20 order in accordance with paragraphs 

21 (2) and (3); and 

22 ‘‘(iii) except as provided in paragraph 

23 (6), if the Secretary determines that a re24 quest does not meet the requirements for 

25 filing or is not sufficiently complete and 


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1 formatted to permit a substantive review, 

2 the requestor may demand that the request 

3 be filed over protest, and the Secretary 

4 shall initiate proceedings to review the re5 quest in accordance with paragraph (2)(A). 

6 ‘‘(B) REQUEST TO INITIATE PRO7 CEEDINGS.— 

8 ‘‘(i) IN GENERAL.—A requestor seek9 ing an administrative order under para10 graph (1) with respect to certain drugs, 

11 classes of drugs, or combinations of drugs, 

12 shall submit to the Secretary a request to 

13 initiate proceedings for such order in the 

14 form and manner as specified by the Sec15 retary. Such requestor may submit a re16 quest under this subparagraph for the 

17 issuance of an administrative order— 

18 ‘‘(I) determining whether a drug 

19 is generally recognized as safe and ef20 fective under section 201(p)(1), ex21 empt from section 503(b)(1), and not 

22 required to be the subject of an ap23 proved application under section 505; 

24 or 


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1 ‘‘(II) determining whether a 

2 change to a condition of use of a drug 

3 is generally recognized as safe and ef4 fective under section 201(p)(1), ex5 empt from section 503(b)(1), and not 

6 required to be the subject of an ap7 proved application under section 505, 

8 if, absent such a changed condition of 

9 use, such drug is— 

10 ‘‘(aa) generally recognized 

11 as safe and effective under sec12 tion 201(p)(1) in accordance with 

13 subsection (a)(1), (a)(2), or an 

14 order under this subsection; or 

15 ‘‘(bb) subject to subsection 

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

17 initiates such request in conjunc18 tion with a request for the Sec19 retary to determine whether such 

20 drug is generally recognized as 

21 safe and effective under section 

22 201(p)(1), which is filed by the 

23 Secretary under subparagraph 

24 (A)(ii). 


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1 ‘‘(ii) EXCEPTION.—The Secretary is 

2 not required to complete review of a re3 quest for a change described in clause 

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

5 there is an inadequate basis to find the 

6 drug is generally recognized as safe and ef7 fective under section 201(p)(1) under para8 graph (1) and issues a final order an9 nouncing that determination. 

10 ‘‘(iii) WITHDRAWAL.—The requestor 

11 may withdraw a request under this para12 graph, according to the procedures set 

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

14 Notwithstanding any other provision of 

15 this section, if such request is withdrawn, 

16 the Secretary may cease proceedings under 

17 this subparagraph. 

18 ‘‘(C) EXCLUSIVITY.— 

19 ‘‘(i) IN GENERAL.—A final adminis20 trative order issued in response to a re21 quest under this section shall have the ef22 fect of authorizing solely the order re23 questor (or the licensees, assignees, or suc24 cessors in interest of such requestor with 

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


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1 period of 18 months following the effective 

2 date of such final order and beginning on 

3 the date the requestor may lawfully market 

4 such drugs pursuant to the order, to mar5 ket drugs— 

6 ‘‘(I) incorporating changes de7 scribed in clause (ii); and 

8 ‘‘(II) subject to the limitations 

9 under clause (iv). 

10 ‘‘(ii) CHANGES DESCRIBED.—A 

11 change described in this clause is a change 

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

13 which— 

14 ‘‘(I) provides for a drug to con15 tain an active ingredient (including 

16 any ester or salt of the active ingre17 dient) not previously incorporated in a 

18 drug described in clause (iii); or 

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

20 conditions of use of a drug, for which 

21 new human data studies conducted or 

22 sponsored by the requestor (or for 

23 which the requestor has an exclusive 

24 right of reference) were essential to 

25 the issuance of such order. 


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1 ‘‘(iii) DRUGS DESCRIBED.—The drugs 

2 described in this clause are drugs— 

3 ‘‘(I) specified in subsection 

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

5 ‘‘(II) subject to a final order 

6 issued under this section; 

7 ‘‘(III) subject to a final sun8 screen order (as defined in section 

9 586(2)(A)); or 

10 ‘‘(IV) described in subsection 

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

12 active enforcement action under chap13 ter III of this Act. 

14 ‘‘(iv) LIMITATIONS ON EXCLU15 SIVITY.— 

16 ‘‘(I) IN GENERAL.—Only one 18- 

17 month period under this subpara18 graph shall be granted, under each 

19 order described in clause (i), with re20 spect to changes (to the drug subject 

21 to such order) which are either— 

22 ‘‘(aa) changes described in 

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

24 ingredients; or 


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1 ‘‘(bb) changes described in 

2 clause (ii)(II), relating to condi3 tions of use. 

4 ‘‘(II) NO EXCLUSIVITY AL5 LOWED.—No exclusivity shall apply to 

6 changes to a drug which are— 

7 ‘‘(aa) the subject of a Tier 2 

8 OTC monograph order request 

9 (as defined in section 744L); 

10 ‘‘(bb) safety-related changes, 

11 as defined by the Secretary, or 

12 any other changes the Secretary 

13 considers necessary to assure 

14 safe use; or 

15 ‘‘(cc) changes related to 

16 methods of testing safety or effi17 cacy. 

18 ‘‘(v) NEW HUMAN DATA STUDIES DE19 FINED.—In this subparagraph, the term 

20 ‘new human data studies’ means clinical 

21 trials of safety or effectiveness (including 

22 actual use studies), pharmacokinetics stud23 ies, or bioavailability studies, the results of 

24 which— 


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1 ‘‘(I) have not been relied on by 

2 the Secretary to support— 

3 ‘‘(aa) a proposed or final de4 termination that a drug described 

5 in subclause (I), (II), or (III) of 

6 clause (iii) is generally recognized 

7 as safe and effective under sec8 tion 201(p)(1); or 

9 ‘‘(bb) approval of a drug 

10 that was approved under section 

11 505; and 

12 ‘‘(II) do not duplicate the results 

13 of another study that was relied on by 

14 the Secretary to support— 

15 ‘‘(aa) a proposed or final de16 termination that a drug described 

17 in subclause (I), (II), or (III) of 

18 clause (iii) is generally recognized 

19 as safe and effective under sec20 tion 201(p)(1); or 

21 ‘‘(bb) approval of a drug 

22 that was approved under section 

23 505. 

24 ‘‘(6) INFORMATION REGARDING SAFE NON25 PRESCRIPTION MARKETING AND USE AS CONDITION


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1 FOR FILING A GENERALLY RECOGNIZED AS SAFE

2 AND EFFECTIVE REQUEST.— 

3 ‘‘(A) IN GENERAL.—In response to a re4 quest under this section that a drug described 

5 in subparagraph (B) be generally recognized as 

6 safe and effective, the Secretary— 

7 ‘‘(i) may file such request, if the re8 quest includes information specified under 

9 subparagraph (C) with respect to safe non10 prescription marketing and use of such 

11 drug; or 

12 ‘‘(ii) if the request fails to include in13 formation specified under subparagraph 

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

15 require that nonprescription marketing of 

16 the drug be pursuant to a new drug appli17 cation as described in subparagraph (D). 

18 ‘‘(B) DRUG DESCRIBED.—A drug de19 scribed in this subparagraph is a nonprescrip20 tion drug which contains an active ingredient 

21 not previously incorporated in a drug— 

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

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

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

25 this section; or 


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1 ‘‘(iii) subject to a final sunscreen 

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

3 ‘‘(C) INFORMATION DEMONSTRATING

4 PRIMA FACIE SAFE NONPRESCRIPTION MAR5 KETING AND USE.—Information specified in 

6 this subparagraph, with respect to a request de7 scribed in subparagraph (A)(i), is— 

8 ‘‘(i) information sufficient for a prima 

9 facie demonstration that the drug subject 

10 to such request has a verifiable history of 

11 being marketed and safely used by con12 sumers in the United States as a non13 prescription drug under comparable condi14 tions of use; 

15 ‘‘(ii) if the drug has not been pre16 viously marketed in the United States as a 

17 nonprescription drug, information suffi18 cient for a prima facie demonstration that 

19 the drug was marketed and safely used 

20 under comparable conditions of marketing 

21 and use in a country listed in section 

22 802(b)(1)(A) or designated by the Sec23 retary in accordance with section 

24 802(b)(1)(B)— 


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1 ‘‘(I) for such period as needed to 

2 provide reasonable assurances con3 cerning the safe nonprescription use 

4 of the drug; and 

5 ‘‘(II) during such time was sub6 ject to sufficient monitoring by a reg7 ulatory body considered acceptable by 

8 the Secretary for such monitoring 

9 purposes, including for adverse events 

10 associated with nonprescription use of 

11 the drug; or 

12 ‘‘(iii) if the Secretary determines that 

13 information described in clause (i) or (ii) is 

14 not needed to provide a prima facie dem15 onstration that the drug can be safely mar16 keted and used as a nonprescription drug, 

17 such other information the Secretary deter18 mines is sufficient for such purposes. 

19 ‘‘(D) MARKETING PURSUANT TO NEW

20 DRUG APPLICATION.—In the case of a request 

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

22 subject to such request may be resubmitted for 

23 filing only if— 

24 ‘‘(i) the drug is marketed as a non25 prescription drug, under conditions of use 


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1 comparable to the conditions specified in 

2 the request, for such period as the Sec3 retary determines appropriate (not to ex4 ceed 5 consecutive years) pursuant to an 

5 application approved under section 505; 

6 and 

7 ‘‘(ii) during such period, 1,000,000 

8 retail packages of the drug, or an equiva9 lent quantity as determined by the Sec10 retary, were distributed for retail sale, as 

11 determined in such manner as the Sec12 retary finds appropriate. 

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

14 the case of a request involving a drug described 

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

16 2017, if the Secretary refuses to file a request 

17 under this paragraph, the requestor may not 

18 file such request over protest under paragraph 

19 (5)(A)(iii). 

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

21 issued under paragraph (2), (4)(A), or (5) may in22 clude requirements for the packaging of a drug to 

23 encourage use in accordance with labeling. Such re24 quirements may include unit dose packaging, re25 quirements for products intended for use by pediVerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443

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1 atric populations, requirements to reduce risk of 

2 harm from unsupervised ingestion, and other appro3 priate requirements. This paragraph does not au4 thorize the Food and Drug Administration to re5 quire standards or testing procedures as described in 

6 part 1700 of title 16, Code of Federal Regulations. 

7 ‘‘(8) FINAL AND TENTATIVE FINAL MONO8 GRAPHS FOR CATEGORY I DRUGS DEEMED FINAL

9 ADMINISTRATIVE ORDERS.— 

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

11 tentative final monograph described in subpara12 graph (B) shall be deemed to be a final admin13 istrative order under this subsection and may 

14 be amended, revoked, or otherwise modified in 

15 accordance with the procedures of this sub16 section. 

17 ‘‘(B) MONOGRAPHS DESCRIBED.—For pur18 poses of subparagraph (A), a final monograph 

19 or tentative final monograph is described in this 

20 subparagraph if it— 

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

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

23 subsection (a); and 

24 ‘‘(ii) represents the most recently pro25 mulgated version of such conditions, inVerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443

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1 cluding as modified, in whole or in part, by 

2 any proposed or final rule. 

3 ‘‘(C) DEEMED ORDERS INCLUDE HARMO4 NIZING TECHNICAL AMENDMENTS.—The 

5 deemed establishment of a final administrative 

6 order under subparagraph (A) shall be con7 strued to include any technical amendments to 

8 such order as the Secretary determines nec9 essary to ensure that such order is appro10 priately harmonized, in terms of terminology or 

11 cross-references, with the applicable provisions 

12 of this Act (and regulations thereunder) and 

13 any other orders issued under this section. 

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

15 ‘‘(1) IN GENERAL.—Minor changes in the dos16 age form of a drug that is described in paragraph 

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

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

19 a requestor without the issuance of an order under 

20 subsection (b) if— 

21 ‘‘(A) the requestor maintains such infor22 mation as is necessary to demonstrate that the 

23 change— 

24 ‘‘(i) will not affect the safety or effec25 tiveness of the drug; and 


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1 ‘‘(ii) will not materially affect the ex2 tent of absorption or other exposure to the 

3 active ingredient in comparison to a suit4 able reference product; and 

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

6 requirements of an applicable administrative 

7 order issued by the Secretary under paragraph 

8 (3). 

9 ‘‘(2) ADDITIONAL INFORMATION.— 

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

11 shall submit records requested by the Secretary 

12 relating to such a minor change under section 

13 704(a)(4), within 15 business days of receiving 

14 such a request, or such longer period as the 

15 Secretary may provide. 

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

17 Secretary determines that the information con18 tained in such records is not sufficient to dem19 onstrate that the change does not affect the 

20 safety or effectiveness of the drug or materially 

21 affect the extent of absorption or other expo22 sure to the active ingredient, the Secretary— 

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

24 drug in writing; and 


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1 ‘‘(ii) if the Secretary so informs the 

2 sponsor, shall provide the sponsor of the 

3 drug with a reasonable opportunity to pro4 vide additional information. 

5 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN6 FORMATION.—If the sponsor fails to provide 

7 such additional information within a time pre8 scribed by the Secretary, or if the Secretary de9 termines that such additional information does 

10 not demonstrate that the change does not— 

11 ‘‘(i) affect the safety or effectiveness 

12 of the drug; or 

13 ‘‘(ii) materially affect the extent of 

14 absorption or other exposure to the active 

15 ingredient in comparison to a suitable ref16 erence product, 

17 the drug as modified is a new drug under sec18 tion 201(p) and shall be deemed to be mis19 branded under section 502(ee). 

20 ‘‘(3) DETERMINING WHETHER A CHANGE WILL

21 AFFECT SAFETY OR EFFECTIVENESS.— 

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

23 issue one or more administrative orders speci24 fying requirements for determining whether a 

25 minor change made by a sponsor pursuant to 


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1 this subsection will affect the safety or effective2 ness of a drug or materially affect the extent of 

3 absorption or other exposure to an active ingre4 dient in the drug in comparison to a suitable 

5 reference product, together with guidance for 

6 applying those orders to specific dosage forms. 

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

8 and guidance issued by the Secretary under 

9 subparagraph (A) shall take into account rel10 evant public standards and standard practices 

11 for evaluating the quality of drugs, and may 

12 take into account the special needs of popu13 lations, including children. 

14 ‘‘(d) CONFIDENTIALITY OF INFORMATION SUB15 MITTED TO THE SECRETARY.— 

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

17 any information, including reports of testing con18 ducted on the drug or drugs involved, that is sub19 mitted by a requestor in connection with proceedings 

20 on an order under this section (including any minor 

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

22 or confidential information subject to section 

23 552(b)(4) of title 5, United States Code, or section 

24 1905 of title 18, United States Code, shall not be 


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1 disclosed to the public unless the requestor consents 

2 to that disclosure. 

3 ‘‘(2) PUBLIC AVAILABILITY.— 

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

5 subparagraph (B), the Secretary shall— 

6 ‘‘(i) make any information submitted 

7 by a requestor in support of a request 

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

9 public not later than the date on which the 

10 proposed order is issued; and 

11 ‘‘(ii) make any information submitted 

12 by any other person with respect to an 

13 order requested (or initiated by the Sec14 retary) under subsection (b), available to 

15 the public upon such submission. 

16 ‘‘(B) LIMITATIONS ON PUBLIC AVAIL17 ABILITY.—Information described in subpara18 graph (A) shall not be made public if— 

19 ‘‘(i) the information pertains to phar20 maceutical quality information, unless such 

21 information is necessary to establish stand22 ards under which a drug is generally rec23 ognized as safe and effective under section 

24 201(p)(1); 


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

2 requestor-initiated request, but the re3 questor withdraws such request, in accord4 ance with withdrawal procedures estab5 lished by the Secretary, before the Sec6 retary issues the proposed order; 

7 ‘‘(iii) the Secretary requests and ob8 tains the information under subsection (c) 

9 and such information is not submitted in 

10 relation to an order under subsection (b); 

11 or 

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

13 contained in raw datasets. 

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

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

16 section shall submit updated drug listing information for 

17 the drug in accordance with section 510(j) within 30 cal18 endar days of the date when the drug is first commercially 

19 marketed, except that a sponsor who was the order re20 questor with respect to an order subject to subsection 

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

22 of such requestor) shall submit updated drug listing infor23 mation on or before the date when the drug is first com24 mercially marketed. 


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1 ‘‘(f) APPROVALS UNDER SECTION 505.—The provi2 sions of this section shall not be construed to preclude a 

3 person from seeking or maintaining the approval of an ap4 plication for a drug under sections 505(b)(1), 505(b)(2), 

5 and 505(j). A determination under this section that a drug 

6 is not subject to section 503(b)(1), is generally recognized 

7 as safe and effective under section 201(p)(1), and is not 

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

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

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

11 that the applicant shall be required to submit for purposes 

12 of such application only information needed to support any 

13 modification of the drug that is not covered by such deter14 mination under this section. 

15 ‘‘(g) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR16 DERS.—The Secretary shall establish, maintain, update 

17 (as determined necessary by the Secretary but no less fre18 quently than annually), and make publicly available, with 

19 respect to orders issued under this section— 

20 ‘‘(1) a repository of each final order and in21 terim final order in effect, including the complete 

22 text of the order; and 

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

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


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

2 and 

3 ‘‘(B) the Secretary’s expectations, if re4 sources permit, for issuance of proposed orders 

5 over a 3-year period. 

6 ‘‘(h) DEVELOPMENT ADVICE TO SPONSORS OR RE7 QUESTORS.—The Secretary shall establish procedures 

8 under which sponsors or requestors may meet with appro9 priate officials of the Food and Drug Administration to 

10 obtain advice on the studies and other information nec11 essary to support submissions under this section and other 

12 matters relevant to the regulation of nonprescription 

13 drugs and the development of new nonprescription drugs 

14 under this section. 

15 ‘‘(i) PARTICIPATION OF MULTIPLE SPONSORS OR RE16 QUESTORS.—The Secretary shall establish procedures to 

17 facilitate efficient participation by multiple sponsors or re18 questors in proceedings under this section, including provi19 sion for joint meetings with multiple sponsors or reques20 tors or with organizations nominated by sponsors or re21 questors to represent their interests in a proceeding. 

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

23 this section shall be in electronic format. 

24 ‘‘(k) EFFECT ON EXISTING REGULATIONS GOV25 ERNING NONPRESCRIPTION DRUGS.— 


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1 ‘‘(1) REGULATIONS OF GENERAL APPLICA2 BILITY TO NONPRESCRIPTION DRUGS.—Except as 

3 provided in this subsection, nothing in this section 

4 supersedes regulations establishing general require5 ments for nonprescription drugs, including regula6 tions of general applicability contained in parts 201, 

7 250, and 330 of title 21, Code of Federal Regula8 tions, or any successor regulations. The Secretary 

9 shall establish or modify such regulations by means 

10 of rulemaking in accordance with section 553 of title 

11 5, United States Code. 

12 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE13 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

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

15 title 21, Code of Federal Regulations, as in ef16 fect on the day before the date of the enact17 ment of this section, shall be deemed to be a 

18 final order under subsection (b). 

19 ‘‘(B) Regulations in effect on the day be20 fore the date of the enactment of this section, 

21 establishing requirements for specific non22 prescription drugs marketed pursuant to this 

23 section (including such requirements in parts 

24 201 and 250 of title 21, Code of Federal Regu25 lations), shall be deemed to be final orders 


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

2 drugs— 

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

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

5 ‘‘(ii) otherwise subject to an order 

6 under this section. 

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

8 Secretary shall withdraw regulations establishing 

9 final monographs and the procedures governing the 

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

11 other relevant parts of title 21, Code of Federal 

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

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

14 changes to such regulations to ensure conformity 

15 with appropriate terminology and cross references. 

16 Notwithstanding subchapter II of chapter 5 of title 

17 5, United States Code, any such withdrawal or tech18 nical changes shall be made without public notice 

19 and comment and shall be effective upon publication 

20 through notice in the Federal Register (or upon such 

21 date as specified in such notice). 

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

23 that specifies— 


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

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

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

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

7 Secretary under this section; 

8 ‘‘(4) consolidated proceedings for appeal and 

9 the procedures for such proceedings where appro10 priate; and 

11 ‘‘(5) for minor changes in drugs, recommenda12 tions on how to comply with the requirements in or13 ders issued under subsection (c)(3). 

14 ‘‘(m) RULE OF CONSTRUCTION.— 

15 ‘‘(1) IN GENERAL.—This section shall not af16 fect the treatment or status of a nonprescription 

17 drug— 

18 ‘‘(A) that is marketed without an applica19 tion approved under section 505 as of the date 

20 of the enactment of this section; 

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

22 under this section; and 

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

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


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1 ‘‘(2) TREATMENT OF PRODUCTS PREVIOUSLY

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

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

5 drug described in subparagraph (B) may only 

6 be lawfully marketed, without an application 

7 approved under section 505, pursuant to an 

8 order issued under this section. 

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

11 enactment of this section, the Secretary deter12 mined in a proposed or final rule to be ineligible 

13 for review under the OTC drug review (as such 

14 phrase ‘OTC drug review’ was used in section 

15 330.14 of title 21, Code of Federal Regulations, 

16 as in effect on the day before the date of the 

17 enactment of this section). 

18 ‘‘(3) PRESERVATION OF AUTHORITY.— 

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

20 construed to preclude or limit the applicability 

21 of any provision of this Act other than this sec22 tion. 

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

24 construed to prohibit the Secretary from issuing 

25 an order under this section finding a drug to be 


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1 not generally recognized as safe and effective 

2 under section 201(p)(1), as the Secretary deter3 mines appropriate. 

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

5 subject to this section if an exemption for investigational 

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

7 ‘‘(o) INAPPLICABILITY OF PAPERWORK REDUCTION

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

9 not apply to collections of information made under this 

10 section. 

11 ‘‘(p) INAPPLICABILITY OF NOTICE AND COMMENT

12 RULEMAKING AND OTHER REQUIREMENTS.—The re13 quirements of subsection (b) shall apply with respect to 

14 orders issued under this section instead of the require15 ments of subchapter II of chapter 5 of title 5, United 

16 States Code. 

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

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

19 a drug not subject to the requirements of section 

20 503(b)(1). 

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

22 marketing, manufacturing, or processing a drug 

23 that— 

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

25 and 


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1 ‘‘(B) is or will be subject to an administra2 tive order under this section of the Food and 

3 Drug Administration. 

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

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

7 (b) GAO STUDY.—Not later than 4 years after the 

8 date of enactment of this Act, the Comptroller General 

9 of the United States shall submit a study to the Com10 mittee on Energy and Commerce of the House of Rep11 resentatives and the Committee on Health, Education, 

12 Labor, and Pensions of the Senate addressing the effec13 tiveness and overall impact of exclusivity under section 

14 505G of the Federal Food, Drug, and Cosmetic Act, as 

15 added by subsection (a), and section 586C of such Act 

16 (21 U.S.C. 360fff–3), including the impact of such exclu17 sivity on consumer access. Such study shall include— 

18 (1) an analysis of the impact of exclusivity 

19 under such section 505G for nonprescription drug 

20 products, including— 

21 (A) the number of nonprescription drug 

22 products that were granted exclusivity and the 

23 indication for which the nonprescription drug 

24 products were determined to be generally recog25 nized as safe and effective; 


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1 (B) whether the exclusivity for such drug 

2 products was granted for— 

3 (i) a new active ingredient (including 

4 any ester or salt of the active ingredient); 

5 or 

6 (ii) changes in the conditions of use of 

7 a drug, for which new human data studies 

8 conducted or sponsored by the requestor 

9 were essential; 

10 (C) whether, and to what extent, the exclu11 sivity impacted the requestor’s or sponsor’s de12 cision to develop the drug product; 

13 (D) an analysis of the implementation of 

14 the exclusivity provision in such section 505G, 

15 including— 

16 (i) the resources used by the Food 

17 and Drug Administration; 

18 (ii) the impact of such provision on 

19 innovation, as well as research and devel20 opment in the nonprescription drug mar21 ket; 

22 (iii) the impact of such provision on 

23 competition in the nonprescription drug 

24 market; 


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1 (iv) the impact of such provision on 

2 consumer access to nonprescription drug 

3 products; 

4 (v) the impact of such provision on 

5 the prices of nonprescription drug prod6 ucts; and 

7 (vi) whether the administrative orders 

8 initiated by requestors under such section 

9 505G have been sufficient to encourage the 

10 development of nonprescription drug prod11 ucts that would likely not be otherwise de12 veloped, or developed in as timely a man13 ner; and 

14 (E) whether the administrative orders ini15 tiated by requestors under such section 505G 

16 have been sufficient incentive to encourage in17 novation in the nonprescription drug market; 

18 and 

19 (2) an analysis of the impact of exclusivity 

20 under such section 586C for sunscreen ingredients, 

21 including— 

22 (A) the number of sunscreen ingredients 

23 that were granted exclusivity and the specific 

24 ingredient that was determined to be generally 

25 recognized as safe and effective; 


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1 (B) whether, and to what extent, the exclu2 sivity impacted the requestor’s or sponsor’s de3 cision to develop the sunscreen ingredient; 

4 (C) whether, and to what extent, the sun5 screen ingredient granted exclusivity had pre6 viously been available outside of the United 

7 States; 

8 (D) an analysis of the implementation of 

9 the exclusivity provision in such section 586C, 

10 including— 

11 (i) the resources used by the Food 

12 and Drug Administration; 

13 (ii) the impact of such provision on 

14 innovation, as well as research and devel15 opment in the sunscreen market; 

16 (iii) the impact of such provision on 

17 competition in the sunscreen market; 

18 (iv) the impact of such provision on 

19 consumer access to sunscreen products; 

20 (v) the impact of such provision on 

21 the prices of sunscreen products; and 

22 (vi) whether the administrative orders 

23 initiated by requestors under such section 

24 505G have been utilized by sunscreen in25 gredient sponsors and whether such procVerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00054 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443

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1 ess has been sufficient to encourage the 

2 development of sunscreen ingredients that 

3 would likely not be otherwise developed, or 

4 developed in as timely a manner; and 

5 (E) whether the administrative orders ini6 tiated by requestors under such section 586C 

7 have been sufficient incentive to encourage in8 novation in the sunscreen market. 

9 (c) CONFORMING AMENDMENT.—Section 751(d)(1) 

10 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 379r(d)(1)) is amended— 

12 (1) in the matter preceding subparagraph (A)— 

13 (A) by striking ‘‘final regulation promul14 gated’’ and inserting ‘‘final order under section 

15 505G’’; and 

16 (B) by striking ‘‘and not misbranded’’; and 

17 (2) in subparagraph (A), by striking ‘‘regula18 tion in effect’’ and inserting ‘‘regulation or order in 

19 effect’’. 

20 SEC. 1002. MISBRANDING. 

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

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

23 following: 

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

25 to section 505G, is not the subject of an application apVerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443

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1 proved under section 505, and does not comply with the 

2 requirements under 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 744M.’’. 

7 SEC. 1003. 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 (as defined in section 505G(q) of the 

12 Federal Food, Drug, and Cosmetic Act, as added by sec13 tion 1001 of this Act) which was excluded by the Food 

14 and Drug Administration from the Over-the-Counter 

15 Drug Review in accordance with the paragraph numbered 

16 25 on page 9466 of volume 37 of the Federal Register, 

17 published on May 11, 1972. 

18 (b) RULE OF CONSTRUCTION.—Nothing in this sec19 tion shall be construed to preclude or limit the applica20 bility of any other provision of the Federal Food, Drug, 

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

22 SEC. 1004. TREATMENT OF SUNSCREEN INNOVATION ACT. 

23 (a) REVIEW OF NONPRESCRIPTION SUNSCREEN AC24 TIVE INGREDIENTS.— 


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1 (1) APPLICABILITY OF SECTION 505G FOR

2 PENDING SUBMISSIONS.— 

3 (A) IN GENERAL.—A sponsor of a non4 prescription sunscreen active ingredient or com5 bination of nonprescription sunscreen active in6 gredients that, as of the date of enactment of 

7 this Act, is subject to a proposed sunscreen 

8 order under section 586C of the Federal Food, 

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

10 may elect, by means of giving written notifica11 tion to the Secretary of Health and Human 

12 Services within 180 calendar days of the enact13 ment of this Act, to transition into the review 

14 of such ingredient or combination of ingredients 

15 pursuant to the process set out in section 505G 

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

17 as added by section 1001 of this Act. 

18 (B) ELECTION EXERCISED.—Upon receipt 

19 by the Secretary of Health and Human Services 

20 of a timely notification under subparagraph 

21 (A)— 

22 (i) the proposed sunscreen order in23 volved is deemed to be a request for an 

24 order under subsection (b) of section 505G 

25 of the Federal Food, Drug, and Cosmetic 


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1 Act, as added by section 1001 of this Act; 

2 and 

3 (ii) such order is deemed to have been 

4 accepted for filing under subsection 

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

6 (C) ELECTION NOT EXERCISED.—If a noti7 fication under subparagraph (A) is not received 

8 by the Secretary of Health and Human Services 

9 within 180 calendar days of the date of enact10 ment of this Act, the review of the proposed 

11 sunscreen order described in subparagraph 

12 (A)— 

13 (i) shall continue under section 586C 

14 of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 360fff–3); and 

16 (ii) shall not be eligible for review 

17 under section 505G, added by section 1001 

18 of this Act. 

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

20 terms ‘‘sponsor’’, ‘‘nonprescription’’, ‘‘sunscreen ac21 tive ingredient’’, and ‘‘proposed sunscreen order’’ 

22 have the meanings given to those terms in section 

23 586 of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 360fff). 

25 (b) AMENDMENTS TO SUNSCREEN PROVISIONS.— 


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1 (1) FINAL SUNSCREEN ORDERS.—Paragraph 

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

3 and Cosmetic Act (21 U.S.C. 360fff–3(e)) is amend4 ed to read as follows: 

5 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC6 TION 505G.—A final sunscreen order shall be deemed 

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

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

9 586C(b) of the Federal Food, Drug, and Cosmetic 

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

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

12 and inserting the following: 

13 ‘‘(A) IN GENERAL.—A sponsor may re14 quest’’; and 

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

16 ‘‘(B) CONFIDENTIAL MEETINGS.—A spon17 sor may request one or more confidential meet18 ings with respect to a proposed sunscreen order, 

19 including a letter deemed to be a proposed sun20 screen order under paragraph (3), to discuss 

21 matters relating to data requirements to sup22 port a general recognition of safety and effec23 tiveness involving confidential information and 

24 public information related to such proposed 

25 sunscreen order, as appropriate. The Secretary 


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1 shall convene a confidential meeting with such 

2 sponsor in a reasonable time period. If a spon3 sor requests more than one confidential meeting 

4 for 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. This subparagraph 

17 does not authorize the disclosure of confidential 

18 commercial information or trade secrets subject 

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

20 section 1905 of title 18, United States Code.’’. 

21 (3) EXCLUSIVITY.—Section 586C of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

23 360fff–3) is amended by adding at the end the fol24 lowing: 

25 ‘‘(f) EXCLUSIVITY.— 


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1 ‘‘(1) IN GENERAL.—A final sunscreen order 

2 shall have the effect of authorizing solely the order 

3 requestor (or the licensees, assignees, or successors 

4 in interest of such requestor with respect to the sub5 ject of such request and listed under paragraph (5)) 

6 for a period of 18 months, to market a sunscreen in7 gredient under this section incorporating changes 

8 described in paragraph (2) subject to the limitations 

9 under paragraph (4), beginning on the date the re10 questor (or any licensees, assignees, or successors in 

11 interest of such requestor with respect to the subject 

12 of such request and listed under paragraph (5)) may 

13 lawfully market such sunscreen ingredient pursuant 

14 to the order. 

15 ‘‘(2) CHANGES DESCRIBED.—A change de16 scribed in this paragraph is a change subject to an 

17 order specified in paragraph (1) that permits a sun18 screen to contain an active sunscreen ingredient not 

19 previously incorporated in a marketed sunscreen list20 ed in paragraph (3). 

21 ‘‘(3) MARKETED SUNSCREEN.—The marketed 

22 sunscreen ingredients described in this paragraph 

23 are sunscreen ingredients— 

24 ‘‘(A) marketed in accordance with a final 

25 monograph for sunscreen drug products set 


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1 forth at part 352 of title 21, Code of Federal 

2 Regulations (as published at 64 Fed. Reg. 

3 27687); or 

4 ‘‘(B) marketed in accordance with a final 

5 order issued under this section. 

6 ‘‘(4) LIMITATIONS ON EXCLUSIVITY.—Only one 

7 18-month period may be granted per ingredient 

8 under paragraph (1). 

9 ‘‘(5) LISTING OF LICENSEES, ASSIGNEES, OR

10 SUCCESSORS IN INTEREST.—Requestors shall submit 

11 to the Secretary at the time when a drug subject to 

12 such request is introduced or delivered for introduc13 tion into interstate commerce, a list of licensees, as14 signees, or successors in interest under paragraph 

15 (1).’’. 

16 (4) SUNSET PROVISION.—Subchapter I of chap17 ter V of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 360fff et seq.) is amended by adding at 

19 the end the following: 

20 ‘‘SEC. 586H. SUNSET. 

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

22 of fiscal year 2022.’’. 

23 (5) TREATMENT OF FINAL SUNSCREEN

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


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

2 (21 U.S.C. 360fff–5). 

3 (c) TREATMENT OF AUTHORITY REGARDING FINAL4 IZATION OF SUNSCREEN MONOGRAPH.— 

5 (1) IN GENERAL.— 

6 (A) REVISION OF FINAL SUNSCREEN

7 ORDER.—Not later than November 26, 2019, 

8 the Secretary of Health and Human Services 

9 (referred to in this subsection as the ‘‘Sec10 retary’’) shall amend and revise the final ad11 ministrative order concerning nonprescription 

12 sunscreen (referred to in this subsection as the 

13 ‘‘sunscreen order’’) for which the content, prior 

14 to the date of enactment of this Act, was rep15 resented by the final monograph for sunscreen 

16 drug products set forth in part 352 of title 21, 

17 Code of Federal Regulations (as in effect on 

18 May 21, 1999). 

19 (B) ISSUANCE OF REVISED SUNSCREEN

20 ORDER; EFFECTIVE DATE.—A revised sunscreen 

21 order described in subparagraph (A) shall be— 

22 (i) issued in accordance with the pro23 cedures described in section 505G(c)(2) of 

24 the Federal Food, Drug, and Cosmetic 

25 Act; 


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1 (ii) issued in proposed form not later 

2 than May 28, 2019; 

3 (iii) effective not later than November 

4 26, 2020; and 

5 (iv) issued by the Secretary at least 1 

6 year prior to the effective date of the re7 vised order. 

8 (2) REPORTS.—If a revised sunscreen order 

9 issued under paragraph (1) does not include provi10 sions related to the effectiveness of various sun pro11 tection factor levels, and does not address all dosage 

12 forms known to the Secretary to be used in sun13 screens marketed in the United States without a 

14 new drug application approved under section 505 of 

15 the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 355), the Secretary shall submit a report to 

17 the Committee on Energy and Commerce of the 

18 House of Representatives and the Committee on 

19 Health, Education, Labor, and Pensions of the Sen20 ate on the rationale for omission of such provisions 

21 from such order, and a plan and timeline to compile 

22 any information necessary to address such provisions 

23 through such order. 

24 (d) 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 pursuant to section 330.14 of title 

5 21, Code of Federal Regulations, as such provisions 

6 were in effect immediately prior to the date of enact7 ment date of this Act, shall be extinguished as of 

8 such date of enactment, subject to paragraph (2). 

9 (2) ORDER REQUEST.—Nothing in paragraph 

10 (1) precludes the submission of an order request 

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

12 and Cosmetic Act, as added by section 1001 of this 

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

14 an application extinguished under paragraph (1). 

15 SEC. 1005. ANNUAL UPDATE TO CONGRESS ON APPRO16 PRIATE PEDIATRIC INDICATION FOR CER17 TAIN OTC COUGH AND COLD DRUGS. 

18 (a) IN GENERAL.—Subject to subsection (c), the Sec19 retary of Health and Human Services shall, beginning not 

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

21 annually submit to the Committee on Energy and Com22 merce of the House of Representatives and the Committee 

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

24 a letter describing the progress of the Food and Drug Ad25 ministration— 


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1 (1) in evaluating the cough and cold monograph 

2 described in subsection (b) with respect to children 

3 under age 6; and 

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

5 monograph to address such children through the 

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

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

8 1001 of this Act. 

9 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

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

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

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

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

19 Food, Drug, and Cosmetic Act, as added by section 1001 

20 of this Act. 

21 (c) DURATION OF AUTHORITY.—The requirement 

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

23 letter submitted by the Secretary of Health and Human 

24 Services pursuant to such subsection in which the Sec25 retary indicates that the Food and Drug Administration 


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

2 as applicable, the cough and cold monograph as described 

3 in subsection (a)(2). 

4 SEC. 1006. TECHNICAL CORRECTIONS. 

5 (a) IMPORTS AND EXPORTS.—Section 

6 801(e)(4)(E)(iii) of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 381(e)(4)(E)(iii)) is amended by striking 

8 ‘‘subparagraph’’ each place such term appears and insert9 ing ‘‘paragraph’’. 

10 (b) FDA REAUTHORIZATION ACT OF 2017.— 

11 (1) IN GENERAL.—Section 905(b)(4) of the 

12 FDA Reauthorization Act of 2017 (Public Law 115– 

13 52) is amended by striking ‘‘Section 744H(e)(2)(B)’’ 

14 and inserting ‘‘Section 744H(f)(2)(B)’’. 

15 (2) EFFECTIVE DATE.—The amendment made 

16 by paragraph (1) shall take effect as of the enact17 ment of the FDA Reauthorization Act of 2017 

18 (Public Law 115–52). 

19 TITLE II—USER FEES 

20 SEC. 2001. SHORT TITLE; FINDING. 

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

22 ‘‘Over-the-Counter Monograph User Fee Act of 2019’’. 

23 (b) FINDING.—The Congress finds that the fees au24 thorized by the amendments made in this title will be dedi25 cated to OTC monograph drug activities, as set forth in 


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1 the goals identified for purposes of part 10 of subchapter 

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

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

4 Human Services to the Chairman of the Committee on 

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

6 the Chairman of the Committee on Energy and Commerce 

7 of the House of Representatives, as set forth in the Con8 gressional Record. 

9 SEC. 2002. FEES RELATING TO OVER-THE-COUNTER DRUGS. 

10 Subchapter C of chapter VII of the Federal Food, 

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

12 amended by inserting after part 9 the following: 

13 ‘‘PART 10—FEES RELATING TO OVER-THE14 COUNTER DRUGS 

15 ‘‘SEC. 744L. DEFINITIONS. 

16 ‘‘In this part: 

17 ‘‘(1) The term ‘affiliate’ means a business enti18 ty that has a relationship with a second business en19 tity if, directly or indirectly— 

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

21 the power to control, the other business entity; 

22 or 

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

24 to control, both of the business entities. 


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1 ‘‘(2) The term ‘contract manufacturing organi2 zation facility’ means an OTC monograph drug facil3 ity where neither the owner of such manufacturing 

4 facility nor any affiliate of such owner or facility 

5 sells the OTC monograph drug produced at such fa6 cility directly to wholesalers, retailers, or consumers 

7 in the United States. 

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

9 OTC monograph drug activities’ means the expenses 

10 in connection with OTC monograph drug activities 

11 for— 

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

13 and Drug Administration, contractors of the 

14 Food and Drug Administration, advisory com15 mittees, and costs related to such officers, em16 ployees, and committees and costs related to 

17 contracts with such contractors; 

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

19 acquisition, maintenance, and repair of com20 puter resources; 

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

22 repair of facilities and acquisition, maintenance, 

23 and repair of fixtures, furniture, scientific 

24 equipment, and other necessary materials and 

25 supplies; and 


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1 ‘‘(D) collecting fees under section 744M 

2 and accounting for resources allocated for OTC 

3 monograph drug activities. 

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

5 the unique number automatically generated by Food 

6 and Drug Administration’s Field Accomplishments 

7 and Compliance Tracking System (FACTS) (or any 

8 successor system). 

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

10 nonprescription drug without an approved new drug 

11 application which is governed by the provisions of 

12 section 505G. 

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

14 means activities of the Secretary associated with 

15 OTC monograph drugs and inspection of facilities 

16 associated with such products, including the fol17 lowing activities: 

18 ‘‘(A) The activities necessary for review 

19 and evaluation of OTC monographs and OTC 

20 monograph order requests, including— 

21 ‘‘(i) orders proposing or finalizing ap22 plicable conditions of use for OTC mono23 graph drugs; 

24 ‘‘(ii) orders affecting status regarding 

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1 ness of an OTC monograph ingredient or 

2 combination of ingredients under specified 

3 conditions of use; 

4 ‘‘(iii) all OTC monograph drug devel5 opment and review activities, including 

6 intra-agency collaboration; 

7 ‘‘(iv) regulation and policy develop8 ment activities related to OTC monograph 

9 drugs; 

10 ‘‘(v) development of product standards 

11 for products subject to review and evalua12 tion; 

13 ‘‘(vi) meetings referred to in section 

14 505G(i); 

15 ‘‘(vii) review of labeling prior to 

16 issuance of orders related to OTC mono17 graph drugs or conditions of use; and 

18 ‘‘(viii) regulatory science activities re19 lated to OTC monograph drugs. 

20 ‘‘(B) Inspections related to OTC mono21 graph drugs. 

22 ‘‘(C) Monitoring of clinical and other re23 search conducted in connection with OTC 

24 monograph drugs. 


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

2 monograph drugs, including— 

3 ‘‘(i) collecting, developing, and review4 ing safety information on OTC monograph 

5 drugs, including adverse event reports; 

6 ‘‘(ii) developing and using improved 

7 adverse event data-collection systems, in8 cluding information technology systems; 

9 and 

10 ‘‘(iii) developing and using improved 

11 analytical tools to assess potential safety 

12 risks, including access to external data13 bases. 

14 ‘‘(E) Other activities necessary for imple15 mentation of section 505G. 

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

17 means a request for an order submitted under sec18 tion 505G(b)(5). 

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

20 request’ means any OTC monograph order request 

21 not determined to be a Tier 2 OTC monograph 

22 order request. 

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

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

25 an OTC monograph order request for— 


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1 ‘‘(i) the reordering of existing information 

2 in the drug facts label of an OTC monograph 

3 drug; 

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

5 other information section of the drug facts label 

6 of an OTC monograph drug, as limited by sec7 tion 201.66(c)(7) of title 21, Code of Federal 

8 Regulations (or any successor regulations); 

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

10 section of the drug facts label of an OTC mono11 graph drug, if such changes conform to changes 

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

13 ‘‘(iv) the standardization of the concentra14 tion or dose of a specific finalized ingredient 

15 within a particular finalized monograph; 

16 ‘‘(v) a change to ingredient nomenclature 

17 to align with nomenclature of a standards-set18 ting organization; or 

19 ‘‘(vi) addition of an interchangeable term 

20 in accordance with section 330.1 of title 21, 

21 Code of Federal Regulations (or any successor 

22 regulations). 

23 ‘‘(B) The Secretary may, based on program im24 plementation experience or other factors found ap25 propriate by the Secretary, characterize any OTC 


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1 monograph order request as a Tier 2 OTC mono2 graph order request (including recharacterizing a re3 quest from Tier 1 to Tier 2) and publish such deter4 mination in a proposed order issued pursuant to sec5 tion 505G. 

6 ‘‘(10)(A) The term ‘OTC monograph drug facil7 ity’ means a foreign or domestic business or other 

8 entity that— 

9 ‘‘(i) is— 

10 ‘‘(I) under one management, either di11 rect or indirect; and 

12 ‘‘(II) at one geographic location or ad13 dress engaged in manufacturing or proc14 essing the finished dosage form of an OTC 

15 monograph drug; 

16 ‘‘(ii) includes a finished dosage form man17 ufacturer facility in a contractual relationship 

18 with the sponsor of one or more OTC mono19 graph drugs to manufacture or process such 

20 drugs; and 

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

22 entity whose only manufacturing or processing 

23 activities are one or more of the following: pro24 duction of clinical research supplies, testing, or 

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1 taining multiple products, for such purposes as 

2 creating multipacks, when each monograph 

3 drug product contained within the overpack4 aging is already in a final packaged form prior 

5 to placement in the outer overpackaging. 

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

7 separate buildings or locations within close proximity 

8 are considered to be at one geographic location or 

9 address if the activities conducted in such buildings 

10 or locations are— 

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

12 enterprise; 

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

14 local management; and 

15 ‘‘(iii) under a single FDA establishment 

16 identifier and capable of being inspected by the 

17 Food and Drug Administration during a single 

18 inspection. 

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

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

21 under multiple management, the business or other 

22 entity is deemed to constitute multiple facilities, one 

23 per management entity, for purposes of this para24 graph. 


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1 ‘‘(11) The term ‘OTC monograph drug meet2 ing’ means any meeting regarding the content of a 

3 proposed OTC monograph order request. 

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

5 a person. 

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

7 the meanings given such terms in section 505G. 

8 ‘‘SEC. 744M. AUTHORITY TO ASSESS AND USE OTC MONO9 GRAPH FEES. 

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

11 2019, the Secretary shall assess and collect fees in accord12 ance with this section as follows: 

13 ‘‘(1) FACILITY FEE.— 

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

15 owns a facility identified as an OTC monograph 

16 drug facility on December 31 of the fiscal year 

17 or at any time during the preceding 12-month 

18 period shall be assessed an annual fee for each 

19 such facility as determined under subsection 

20 (c). 

21 ‘‘(B) EXCEPTIONS.— 

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

23 subparagraph (A) if the identified OTC 

24 monograph drug facility— 


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1 ‘‘(I) has ceased all activities re2 lated to OTC monograph drugs prior 

3 to January 31, 2019, for the first pro4 gram year, and December 31 of the 

5 fiscal year for subsequent fiscal years; 

6 and 

7 ‘‘(II) has updated its registration 

8 to reflect such change under the re9 quirements for drug establishment 

10 registration set forth in section 510. 

11 ‘‘(ii) The amount of the fee for a con12 tract manufacturing organization facility 

13 shall be equal to two-thirds of the amount 

14 of the fee for an OTC monograph drug fa15 cility that is not a contract manufacturing 

16 organization facility. 

17 ‘‘(C) AMOUNT.—The amount of fees estab18 lished under subparagraph (A) shall be estab19 lished under subsection (c). 

20 ‘‘(D) DUE DATE.— 

21 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

22 fiscal year 2019, the facility fees required 

23 under subparagraph (A) shall be due 45 

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1 eral Register notice provided for under 

2 subsection (c)(4)(A). 

3 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

4 For each fiscal year after fiscal year 2019, 

5 the facility fees required under subpara6 graph (A) shall be due on the later of— 

7 ‘‘(I) the first business day of 

8 June of such year; or 

9 ‘‘(II) the first business day after 

10 the enactment of an appropriations 

11 Act providing for the collection and 

12 obligation of fees under this section 

13 for such year. 

14 ‘‘(2) OTC MONOGRAPH ORDER REQUEST

15 FEE.— 

16 ‘‘(A) IN GENERAL.—Each person that sub17 mits an OTC monograph order request shall be 

18 subject to a fee for an OTC monograph order 

19 request. The amount of such fee shall be— 

20 ‘‘(i) for a Tier 1 OTC monograph 

21 order request, $500,000, adjusted for in22 flation for the fiscal year (as determined 

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

24 ‘‘(ii) for a Tier 2 OTC monograph 

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1 tion for the fiscal year (as determined 

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

3 ‘‘(B) DUE DATE.—The OTC monograph 

4 order request fees required under subparagraph 

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

6 the OTC monograph order request. 

7 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

8 CHANGES.—A person who is named as the re9 questor in an OTC monograph order shall not 

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

11 the Secretary finds that the OTC monograph 

12 order request seeks to change the drug facts la13 beling of an OTC monograph drug in a way 

14 that would add to or strengthen— 

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

16 precaution; 

17 ‘‘(ii) a statement about risk associated 

18 with misuse or abuse; or 

19 ‘‘(iii) an instruction about dosage and 

20 administration that is intended to increase 

21 the safe use of the OTC monograph drug. 

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

23 IS RECATEGORIZED AS A TIER 2 OTC MONO24 GRAPH ORDER REQUEST.—If the Secretary de25 termines that an OTC monograph request iniVerDate Sep 11 2014 04:32 Jun 29, 2019 Jkt 089200 PO 00000 Frm 00079 Fmt 6652 Sfmt 6201 E:\BILLS\H3443.IH H3443

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1 tially characterized as Tier 1 shall be re-charac2 terized as a Tier 2 OTC monograph order re3 quest, and the requestor has paid a Tier 1 fee 

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

5 Secretary shall refund the requestor the dif6 ference between the Tier 1 and Tier 2 fees de7 termined under subparagraphs (A)(i) and 

8 (A)(ii), respectively. 

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

10 REFUSED FOR FILING OR WITHDRAWN BEFORE

11 FILING.—The Secretary shall refund 75 percent 

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

13 order request which is refused for filing or was 

14 withdrawn before being accepted or refused for 

15 filing. 

16 ‘‘(F) FEES FOR ORDER REQUESTS PRE17 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

18 BEFORE FILING.—An OTC monograph order 

19 request that was submitted but was refused for 

20 filing, or was withdrawn before being accepted 

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

22 fee under subparagraph (A) upon being resub23 mitted or filed over protest. 

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

25 WITHDRAWN.—If an order request is withdrawn 


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1 after the order request was filed, the Secretary 

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

3 substantial work was performed on the order 

4 request after the application was filed. The Sec5 retary shall have the sole discretion to refund a 

6 fee or a portion of the fee under this subpara7 graph. A determination by the Secretary con8 cerning a refund under this subparagraph shall 

9 not be reviewable. 

10 ‘‘(3) REFUNDS.— 

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

12 provided pursuant to any of subparagraphs (D) 

13 through (G) of paragraph (2), the Secretary 

14 shall not refund any fee paid under paragraph 

15 (1) except as provided in subparagraph (B). 

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

17 qualify for the return of a fee claimed to have 

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

19 a person shall submit to the Secretary a written 

20 request justifying such return within 180 cal21 endar days after such fee was paid. 

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

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

24 Federal Register the amount of the fees under para25 graph (1) for such fiscal year. 


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1 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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

4 generate a total facility fee revenue amount equal to 

5 the sum of— 

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

7 year 2019 (as determined under paragraph 

8 (3)); 

9 ‘‘(B) the dollar amount equal to the oper10 ating reserve adjustment for the fiscal year, if 

11 applicable (as determined under subsection 

12 (c)(2)); and 

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

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

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

16 the fiscal years 2020 through 2023, fees under sub17 section (a)(1) shall be established to generate a total 

18 facility fee revenue amount equal to the sum of— 

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

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

21 ‘‘(B) the dollar amount equal to the infla22 tion adjustment for the fiscal year (as deter23 mined under subsection (c)(1)); 

24 ‘‘(C) the dollar amount equal to the oper25 ating reserve adjustment for the fiscal year, if 


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1 applicable (as determined under subsection 

2 (c)(2)); 

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

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

5 ‘‘(E) additional dollar amounts for each 

6 fiscal year as follows: 

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

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

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

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

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

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

13 of the annual base revenue for a fiscal year shall 

14 be— 

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

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

17 the dollar amount of the total revenue amount 

18 established under this subsection for the pre19 vious fiscal year, not including any adjustments 

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

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

22 ‘‘(1) INFLATION ADJUSTMENT.— 

23 ‘‘(A) IN GENERAL.—For purposes of sub24 section (b)(2)(B), the dollar amount of the in25 flation adjustment to the annual base revenue 


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1 for fiscal year 2020 and each subsequent fiscal 

2 year shall be equal to the product of— 

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

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

5 ‘‘(ii) the inflation adjustment percent6 age under subparagraph (C). 

7 ‘‘(B) OTC MONOGRAPH ORDER REQUEST

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

9 dollar amount of the inflation adjustment to the 

10 fee for OTC monograph order requests for fis11 cal year 2020 and each subsequent fiscal year 

12 shall be equal to the product of— 

13 ‘‘(i) the applicable fee under sub14 section (a)(2) for the preceding fiscal year; 

15 and 

16 ‘‘(ii) the inflation adjustment percent17 age under subparagraph (C). 

18 ‘‘(C) INFLATION ADJUSTMENT PERCENT19 AGE.—The inflation adjustment percentage 

20 under this subparagraph for a fiscal year is 

21 equal to— 

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

23 2021, the average annual percent change 

24 that occurred in the Consumer Price Index 

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1 more, DC–MD–VA–WV; Not Seasonally 

2 Adjusted; All items; Annual Index) for the 

3 first 3 years of the preceding 4 years of 

4 available data; and 

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

6 2023, the sum of— 

7 ‘‘(I) the average annual percent 

8 change in the cost, per full-time equiv9 alent position of the Food and Drug 

10 Administration, of all personnel com11 pensation and benefits paid with re12 spect to such positions for the first 3 

13 years of the preceding 4 fiscal years, 

14 multiplied by the proportion of per15 sonnel compensation and benefits 

16 costs to total costs of OTC mono17 graph drug activities for the first 3 

18 years of the preceding 4 fiscal years; 

19 and 

20 ‘‘(II) the average annual percent 

21 change that occurred in the Consumer 

22 Price Index for urban consumers 

23 (Washington-Baltimore, DC–MD–VA– 

24 WV; Not Seasonally Adjusted; All 

25 items; Annual Index) for the first 3 


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1 years of the preceding 4 years of 

2 available data multiplied by the pro3 portion of all costs other than per4 sonnel compensation and benefits 

5 costs to total costs of OTC mono6 graph drug activities for the first 3 

7 years of the preceding 4 fiscal years. 

8 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

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

10 and subsequent fiscal years, for purposes of 

11 subsections (b)(1)(B) and (b)(2)(C), the Sec12 retary may, in addition to adjustments under 

13 paragraph (1), further increase the fee revenue 

14 and fees if such an adjustment is necessary to 

15 provide operating reserves of carryover user 

16 fees for OTC monograph drug activities for not 

17 more than the number of weeks specified in 

18 subparagraph (B). 

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

20 weeks specified in this subparagraph is— 

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

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

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

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

25 and 


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

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

3 carryover balances for such process in excess of 

4 10 weeks of the operating reserves referred to 

5 in subparagraph (A), the Secretary shall de6 crease the fee revenue and fees referred to in 

7 such subparagraph to provide for not more than 

8 10 weeks of such operating reserves. 

9 ‘‘(D) RATIONALE FOR ADJUSTMENT.—If 

10 an adjustment under this paragraph is made, 

11 the rationale for the amount of the increase or 

12 decrease (as applicable) in fee revenue and fees 

13 shall be contained in the annual Federal Reg14 ister notice under paragraph (4) establishing 

15 fee revenue and fees for the fiscal year involved. 

16 ‘‘(3) ADDITIONAL DIRECT COST ADJUST17 MENT.—The Secretary shall, in addition to adjust18 ments under paragraphs (1) and (2), further in19 crease the fee revenue and fees for purposes of sub20 section (b)(2)(D) by an amount equal to— 

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

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

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

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

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


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1 ‘‘(4) ANNUAL FEE SETTING.— 

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

3 shall, not later than the second Monday in 

4 March of 2019— 

5 ‘‘(i) establish OTC monograph drug 

6 facility fees for fiscal year 2019 under sub7 section (a), based on the revenue amount 

8 for such year under subsection (b) and the 

9 adjustments provided under this sub10 section; and 

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

12 and OTC monograph order requests in the 

13 Federal Register. 

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

15 Secretary shall, not later than the second Mon16 day in March of each fiscal year that begins 

17 after September 30, 2019— 

18 ‘‘(i) establish for each such fiscal 

19 year, based on the revenue amounts under 

20 subsection (b) and the adjustments pro21 vided under this subsection— 

22 ‘‘(I) OTC monograph drug facil23 ity fees under subsection (a)(1); and 


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1 ‘‘(II) OTC monograph order re2 quest fees under subsection (a)(2); 

3 and 

4 ‘‘(ii) publish such fee revenue 

5 amounts, facility fees, and OTC mono6 graph order request fees in the Federal 

7 Register. 

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

9 that owns an OTC monograph drug facility shall submit 

10 to the Secretary the information required under this sub11 section each year. Such information shall, for each fiscal 

12 year— 

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

14 for drug establishment registration set forth in sec15 tion 510; and 

16 ‘‘(2) include for each such facility, at a min17 imum, identification of the facility’s business oper18 ation as that of an OTC monograph drug facility. 

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

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

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

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

23 of the due date as specified in subparagraph 

24 (D) of such subsection shall result in the fol25 lowing: 


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1 ‘‘(i) The Secretary shall place the fa2 cility on a publicly available arrears list. 

3 ‘‘(ii) All OTC monograph drugs man4 ufactured in such a facility or containing 

5 an ingredient manufactured in such a facil6 ity shall be deemed misbranded under sec7 tion 502(ff). 

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

9 penalties under this paragraph shall apply until 

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

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

12 order request submitted by a person subject to fees 

13 under subsection (a) shall be considered incomplete 

14 and shall not be accepted for filing by the Secretary 

15 until all fees owed by such person under this section 

16 have been paid. 

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

18 under this section shall be considered ineligible for 

19 OTC monograph drug meetings until all such fees 

20 owed by such person have been paid. 

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

22 ‘‘(1) IN GENERAL.—Fees authorized under sub23 section (a) shall be collected and available for obliga24 tion only to the extent and in the amount provided 

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1 thorized to remain available until expended. Such 

2 sums as may be necessary may be transferred from 

3 the Food and Drug Administration salaries and ex4 penses appropriation account without fiscal year lim5 itation to such appropriation account for salaries 

6 and expenses with such fiscal year limitation. The 

7 sums transferred shall be available solely for OTC 

8 monograph drug activities. 

9 ‘‘(2) COLLECTIONS AND APPROPRIATION

10 ACTS.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (C), the fees authorized by this section 

13 shall be collected and available in each fiscal 

14 year in an amount not to exceed the amount 

15 specified in appropriation Acts, or otherwise 

16 made available for obligation, for such fiscal 

17 year. 

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

19 The fees authorized by this section shall be 

20 available to defray increases in the costs of the 

21 resources allocated for OTC monograph drug 

22 activities (including increases in such costs for 

23 an additional number of full-time equivalent po24 sitions in the Department of Health and 

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1 ties), only if the Secretary allocates for such 

2 purpose an amount for such fiscal year (exclud3 ing amounts from fees collected under this sec4 tion) no less than $12,000,000, multiplied by 

5 the adjustment factor applicable to the fiscal 

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

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

8 be considered to have met the requirements of 

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

10 funded by appropriations and allocated for OTC 

11 monograph drug activities are not more than 15 

12 percent below the level specified in such sub13 paragraph. 

14 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

15 SUBSEQUENT YEARS.—Payment of fees author16 ized under this section for a fiscal year (after 

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

18 fees, may be accepted by the Secretary in ac19 cordance with authority provided in advance in 

20 a prior year appropriations Act. 

21 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

22 For each of the fiscal years 2019 through 2023, 

23 there is authorized to be appropriated for fees under 

24 this section an amount equal to the total amount of 

25 fees assessed for such fiscal year under this section. 


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

2 where the Secretary does not receive payment of a fee as3 sessed under subsection (a) within 30 calendar days after 

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

5 States Government subject to subchapter II of chapter 37 

6 of title 31, United States Code. 

7 ‘‘(h) CONSTRUCTION.—This section may not be con8 strued to require that the number of full-time equivalent 

9 positions in the Department of Health and Human Serv10 ices, for officers, employers, and advisory committees not 

11 engaged in OTC monograph drug activities, be reduced 

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

13 committees so engaged. 

14 ‘‘SEC. 744N. REAUTHORIZATION; REPORTING REQUIRE15 MENTS. 

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

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

18 end of each fiscal year thereafter for which fees are col19 lected under this part, the Secretary shall prepare and 

20 submit to the Committee on Energy and Commerce of the 

21 House of Representatives and the Committee on Health, 

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

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1 graph Safety, Innovation, and Reform Act of 2019 during 

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

3 Drug Administration for meeting such goals. 

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

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

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

7 the Secretary shall prepare and submit to the Committee 

8 on Energy and Commerce of the House of Representatives 

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

10 Pensions of the Senate a report on the implementation 

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

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

13 collected for such fiscal year. 

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

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

16 available to the public on the internet website of the Food 

17 and Drug Administration. 

18 ‘‘(d) REAUTHORIZATION.— 

19 ‘‘(1) CONSULTATION.—In developing rec20 ommendations to present to the Congress with re21 spect to the goals described in subsection (a), and 

22 plans for meeting the goals, for OTC monograph 

23 drug activities for the first 5 fiscal years after fiscal 

24 year 2023, and for the reauthorization of this part 


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1 for such fiscal years, the Secretary shall consult 

2 with— 

3 ‘‘(A) the Committee on Energy and Com4 merce of the House of Representatives; 

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

6 Labor, and Pensions of the Senate; 

7 ‘‘(C) scientific and academic experts; 

8 ‘‘(D) health care professionals; 

9 ‘‘(E) representatives of patient and con10 sumer advocacy groups; and 

11 ‘‘(F) the regulated industry. 

12 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA13 TIONS.—After negotiations with the regulated indus14 try, the Secretary shall— 

15 ‘‘(A) present the recommendations devel16 oped under paragraph (1) to the congressional 

17 committees specified in such paragraph; 

18 ‘‘(B) publish such recommendations in the 

19 Federal Register; 

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

21 days for the public to provide written comments 

22 on such recommendations; 

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

24 may present its views on such recommenda25 tions; and 


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1 ‘‘(E) after consideration of such public 

2 views and comments, revise such recommenda3 tions as necessary. 

4 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

5 Not later than January 15, 2023, the Secretary 

6 shall transmit to the Congress the revised rec7 ommendations under paragraph (2), a summary of 

8 the views and comments received under such para9 graph, and any changes made to the recommenda10 tions in response to such views and comments.’’. 

Æ 


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