II 

115TH CONGRESS 

2D SESSION S. 2315 

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

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

IN THE SENATE OF THE UNITED STATES 

JANUARY 17, 2018 

Mr. ISAKSON (for himself and Mr. CASEY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

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

clarify the regulatory framework with respect to certain 

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

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Over-the-Counter Drug Safety, Innovation, and Reform 

6 Act’’. 

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

8 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

TITLE I—REGULATION OF NONPRESCRIPTION DRUGS 

Sec. 101. Regulation of certain nonprescription drugs that are marketed without an approved new drug application. 

Sec. 102. Misbranding. 

Sec. 103. Conforming amendments to the Sunscreen Innovation Act. 

Sec. 104. Drugs excluded from over-the-counter review. 

Sec. 105. Conforming amendment. 

Sec. 106. Annual update to Congress on appropriate pediatric indication for 

certain cough and cold monograph drugs. 

TITLE II—FEES RELATING TO MONOGRAPH DRUGS 

Sec. 201. Short title; findings. 

Sec. 202. Authority to access and use fees. 

1 TITLE I—REGULATION OF 

2 NONPRESCRIPTION DRUGS 

3 SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 

4 DRUGS THAT ARE MARKETED WITHOUT AN 

5 APPROVED NEW DRUG APPLICATION. 

6 Chapter V of the Federal Food, Drug, and Cosmetic 

7 Act is amended by inserting after section 505F (21 U.S.C. 

8 355g) the following: 

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

10 DRUGS THAT ARE MARKETED WITHOUT AN 

11 APPROVED NEW DRUG APPLICATION. 

12 ‘‘(a) DEFINITIONS.—In this section: 

13 ‘‘(1) NONPRESCRIPTION DRUG.—The term 

14 ‘nonprescription drug’ means a drug, an active in15 gredient, or a combination of active ingredients that 

16 is not subject to section 503(b)(1). 


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1 ‘‘(2) REQUESTOR.—The term ‘requestor’ means 

2 a person or group of persons marketing, manufac3 turing, processing, or developing a drug. 

4 ‘‘(3) SPONSOR.—The term ‘sponsor’ means a 

5 person or group of persons marketing, manufac6 turing, or processing a drug and who has a listing 

7 in effect under section 510(j) for such drug. 

8 ‘‘(b) MONOGRAPH DRUGS.— 

9 ‘‘(1) IN GENERAL.—With respect to a non10 prescription drug that, on or after the date of enact11 ment of the Over-the-Counter Drug Safety, Innova12 tion, and Reform Act, is introduced or delivered for 

13 introduction in interstate commerce for which an ap14 proved application under section 505 is not required, 

15 the following shall apply: 

16 ‘‘(A) A nonprescription drug is deemed to 

17 be generally recognized as safe and effective 

18 within the meaning of section 201(p)(1) and 

19 not a new drug under section 201(p) if— 

20 ‘‘(i)(I) such drug is— 

21 ‘‘(aa)(AA) subject to a final 

22 monograph issued under part 

23 330 of title 21, Code of Federal 

24 Regulations, as of the date of en25 actment of the Over-the-Counter 


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1 Drug Safety, Innovation, and Re2 form Act; 

3 ‘‘(BB) in conformity with 

4 the conditions for nonprescription 

5 use of such monograph and the 

6 general requirements specified 

7 for nonprescription drugs, includ8 ing any modifications to those 

9 conditions made under sub10 sections (c), (d), and (j); and 

11 ‘‘(CC) except as permitted 

12 by an administrative order issued 

13 under subsection (c) or a minor 

14 change in the drug in conformity 

15 with subsection (d), is in a dos16 age form that has been used to a 

17 material extent and for a mate18 rial time within the meaning of 

19 section 201(p)(2); or 

20 ‘‘(bb)(AA) the subject of a 

21 tentative final monograph that is 

22 the most recently applicable pro23 posal or determination issued 

24 under part 330 of title 21, Code 

25 of Federal Regulations, as of the 


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1 date of enactment of the Over2 the-Counter Drug Safety, Inno3 vation, and Reform Act; 

4 ‘‘(BB) classified in category 

5 I for safety and effectiveness 

6 under such tentative final mono7 graph; 

8 ‘‘(CC) in conformity with 

9 the conditions for nonprescription 

10 use of such tentative final mono11 graph, any subsequent deter12 mination by the Secretary, and 

13 the general conditions for non14 prescription drugs, including any 

15 modifications of those conditions 

16 under subsections (c), (d), and 

17 (j); and 

18 ‘‘(DD) except as permitted 

19 by an administrative order issued 

20 under subsection (c) or a minor 

21 change in the drug in conformity 

22 with subsection (d), is in a dos23 age form that has been used to a 

24 material extent and for a mateVerDate Sep 11 2014 23:58 Jan 18, 2018 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2315.IS S2315

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1 rial time within the meaning of 

2 section 201(p)(2); or 

3 ‘‘(II) the active ingredient in such 

4 drug is in conformity with— 

5 ‘‘(aa) the requirements of a final 

6 administrative order issued under sub7 section (c) determining that such drug 

8 under the specific conditions of use is 

9 generally recognized as safe and effec10 tive within the meaning of section 

11 201(p)(1); and 

12 ‘‘(bb) the general requirements 

13 for nonprescription drugs, including 

14 any modifications of the requirements 

15 under subsections (c), (d), and (j); 

16 and 

17 ‘‘(ii) such drug is— 

18 ‘‘(I) not classified in Category II 

19 for safety or effectiveness under a ten20 tative final monograph; or 

21 ‘‘(II) determined by the Sec22 retary to be not safe and effective, in 

23 a final monograph or preamble to a 

24 rule that is the most recently applica25 ble proposal or determination issued 


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1 under part 330 of title 21, Code of 

2 Federal Regulations. 

3 ‘‘(B) A nonprescription drug may be intro4 duced into interstate commerce if such drug 

5 is— 

6 ‘‘(i)(I) not classified in Category II 

7 for safety or effectiveness under a tentative 

8 final monograph; or 

9 ‘‘(II) determined by the Secretary to 

10 be not safe and effective, in a final mono11 graph or preamble to a rule that is the 

12 most recently applicable proposal or deter13 mination issued under part 330 of title 21, 

14 Code of Federal Regulations; and 

15 ‘‘(ii)(I)(aa) the subject of a tentative 

16 final monograph that is the most recently 

17 applicable proposal or determination issued 

18 under part 330 of title 21, Code of Federal 

19 Regulations; 

20 ‘‘(bb) classified in category III for 

21 safety or effectiveness in the preamble of a 

22 proposed rule establishing such tentative 

23 final monograph; 

24 ‘‘(cc) in conformity with the most re25 cently proposed or final rule establishing or 


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1 proposing conditions of nonprescription use 

2 published in the Federal Register related 

3 to such tentative final monograph and the 

4 general requirements for nonprescription 

5 drugs, including any modifications of those 

6 requirements under subsections (c) and (j); 

7 and 

8 ‘‘(dd) in a dosage form that has been 

9 used to a material extent and for a mate10 rial time within the meaning of section 

11 201(p)(2); or 

12 ‘‘(II)(aa) the subject of a proposed 

13 monograph or advance notice of proposed 

14 rulemaking that is the most recently appli15 cable proposal or determination issued 

16 under part 330 of title 21, Code of Federal 

17 Regulations; 

18 ‘‘(bb) classified in category I for safe19 ty and effectiveness under such proposed 

20 monograph or advance notice of proposed 

21 rulemaking; 

22 ‘‘(cc) in conformity with the most re23 cently proposed or final rule establishing or 

24 proposing conditions of nonprescription use 

25 published in the Federal Register related 


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1 to such proposed monograph or advance 

2 notice of proposed rulemaking and the gen3 eral requirements for nonprescription 

4 drugs, including any modifications of those 

5 requirements under subsections (c) and (j); 

6 and 

7 ‘‘(dd) in a dosage form that has been 

8 used to a material extent and for a mate9 rial time within the meaning of section 

10 201(p)(2). 

11 ‘‘(C) A nonprescription drug may be intro12 duced into interstate commerce if— 

13 ‘‘(i) such drug is classified in category 

14 II for safety or effectiveness under a ten15 tative final monograph, or the Secretary 

16 has determined such drug not to be safe 

17 and effective in a final monograph or pre18 amble to a rule that is the most recently 

19 applicable proposal or determination issued 

20 under part 330 of title 21, Code of Federal 

21 Regulations; and 

22 ‘‘(ii) the Secretary determines within 

23 6 months of the date of enactment of the 

24 Over-the-Counter Drug Safety, Innovation, 

25 and Reform Act, that it is in the interest 


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1 of public health to extend the period dur2 ing which the drug may be marketed with3 out an approved new drug application 

4 under section 505. 

5 ‘‘(D) A drug that is subject to the final 

6 monograph for sunscreen drug products set 

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

8 Regulations (as published at volume 64 page 

9 27687 of the Federal Register), shall comply 

10 with the requirements of that monograph, ex11 cept that the testing requirements for effective12 ness and the provisions governing labeling shall 

13 be in accordance with section 201.327 of title 

14 21, Code of Federal Regulations (as in effect on 

15 the date of enactment of the Over-the-Counter 

16 Drug Safety, Innovation, and Reform Act), or 

17 such changes to those requirements as may be 

18 made under subsections (c), (d), and (j). 

19 ‘‘(2) NEW DRUGS.—A nonprescription drug is a 

20 new drug within the meaning of section 201(p) and 

21 subject to the requirements of section 505 if the 

22 drug is— 

23 ‘‘(A) not described in subparagraph (A), 

24 (B), or (D) of paragraph (1) and not in con25 formity with subsection (d); 


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1 ‘‘(B) not subject to an administrative final 

2 order pursuant to subsection (c); or 

3 ‘‘(C) not a nonprescription sunscreen ac4 tive ingredient or combination of ingredients 

5 subject to a final sunscreen order, as defined in 

6 section 586(2). 

7 ‘‘(3) MONOGRAPH DRUG.—A nonprescription 

8 drug that is in compliance with paragraph (1) shall 

9 be referred to in this section as a ‘monograph drug’. 

10 ‘‘(4) RULES OF CONSTRUCTION.— 

11 ‘‘(A) IN GENERAL.—This section shall not 

12 affect the treatment or status of a nonprescrip13 tion drug subject to section 505— 

14 ‘‘(i) that, on the date of enactment of 

15 the Over-the-Counter Drug Safety, Innova16 tion, and Reform Act, is marketed without 

17 an application approved under section 505; 

18 and 

19 ‘‘(ii) to which subparagraphs (A), (B), 

20 (C), and (D) of paragraph (1) do not 

21 apply. 

22 ‘‘(B) APPLICABILITY OF OTHER PROVI23 SIONS.—Nothing in this paragraph shall be 

24 construed to preclude or limit the applicability 

25 of any other provision of this Act. 


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1 ‘‘(C) NO EFFECT ON OTHER AUTHORI2 TIES.—Nothing in this subsection shall be con3 strued to prohibit the Secretary from issuing an 

4 order under this section finding a drug to be 

5 not generally recognized as safe and effective. 

6 ‘‘(c) ADMINISTRATIVE ORDERS.— 

7 ‘‘(1) IN GENERAL.— 

8 ‘‘(A) GENERALLY RECOGNIZED AS SAFE

9 AND EFFECTIVE.—The Secretary may, on the 

10 initiative of the Secretary or at the request of 

11 one or more requestors, issue an administrative 

12 order determining whether there are require13 ments under which a specific drug, class of 

14 such drugs, or combination of such drugs is de15 termined to be, after substantive review of evi16 dence— 

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

18 ‘‘(ii) generally recognized as safe and 

19 effective within the meaning of section 

20 201(p)(1); and 

21 ‘‘(iii) not required to be approved 

22 under section 505. 

23 ‘‘(B) NOT GENERALLY RECOGNIZED AS

24 SAFE AND EFFECTIVE.—The Secretary shall 

25 issue an order determining that a drug is not 


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1 generally recognized as safe and effective within 

2 the meaning of section 201(p)(1) for the speci3 fied requirements if, after substantive review of 

4 evidence, the Secretary determines that— 

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

6 is not generally recognized as safe and ef7 fective within the meaning of section 

8 201(p)(1); or 

9 ‘‘(ii) the evidence is inadequate to 

10 show that the drug is generally recognized 

11 as safe and effective within the meaning of 

12 section 201(p)(1). 

13 ‘‘(2) NONAPPLICATION OF CERTAIN REQUIRE14 MENTS.—The requirements of subchapter II of 

15 chapter 5 of title 5, United States Code, shall not 

16 apply with respect to administrative orders issued 

17 under this section. 

18 ‘‘(3) ADMINISTRATIVE ORDERS INITIATED BY

19 THE SECRETARY; CITIZEN PETITIONS.— 

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

21 paragraph (5), in issuing an administrative 

22 order under paragraph (1) on the initiative of 

23 the Secretary, the Secretary shall— 

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1 mally communicate the pending issuance of 

2 the order to sponsors of drugs that will be 

3 subject to such order; 

4 ‘‘(ii) after making any such informal 

5 communication— 

6 ‘‘(I) issue such a proposed ad7 ministrative order by publishing it on 

8 the internet website of the Food and 

9 Drug Administration and include in 

10 such order the reasons for the 

11 issuance of such order; and 

12 ‘‘(II) publish notice of availability 

13 of such proposed order in the Federal 

14 Register; 

15 ‘‘(iii) except as provided in subpara16 graph (B), provide for a public comment 

17 period with respect to such proposed order 

18 of not less than 45 calendar days; and 

19 ‘‘(iv) if, after satisfying the require20 ments of clauses (i) through (iii), the Sec21 retary determines that it is appropriate to 

22 issue a final administrative order— 

23 ‘‘(I) issue the final administrative 

24 order, together with a detailed state25 ment of reasons, but such order shall 


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1 not take effect until the time for re2 questing judicial review under para3 graph (4)(D)(ii) has expired; 

4 ‘‘(II) publish a notice of avail5 ability of such final administrative 

6 order in the Federal Register; 

7 ‘‘(III) afford requestors of prod8 ucts that will be subject to such order 

9 the opportunity for formal dispute 

10 resolution up to the level of the Direc11 tor of the Center for Drug Evaluation 

12 and Research, which initially shall be 

13 requested 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 (4)(B), 

20 upon completion of the formal dispute 

21 resolution procedure, inform the per22 son or persons which sought such dis23 pute resolution of their right to re24 quest a hearing. 


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1 ‘‘(B) SPECIAL REQUIREMENTS WITH RE2 SPECT TO CERTAIN MONOGRAPH DRUGS.— 

3 When issuing an administrative order under 

4 paragraph (1) on the initiative of the Secretary 

5 (except as provided under paragraph (5)) pro6 posing to determine that a monograph drug de7 scribed in subsection (b)(1)(B) is not generally 

8 recognized as safe and effective within the 

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

10 shall follow the procedures in subparagraph (A) 

11 except that— 

12 ‘‘(i) the proposed order shall include 

13 notice of— 

14 ‘‘(I) the general categories of 

15 data the Secretary has determined 

16 necessary to establish that the drug is 

17 generally recognized as safe and effec18 tive within the meaning of section 

19 201(p)(1); and 

20 ‘‘(II) the format for submissions 

21 by interested persons; 

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

23 public comment period of not less than 180 

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1 termines, for good cause, that a shorter pe2 riod is in the interest of public health; and 

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

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

6 evidence created, obtained, or received by 

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

9 order and relevant to a determination as to 

10 whether the drug is generally recognized as 

11 safe and effective within the meaning of 

12 section 201(p)(1). 

13 ‘‘(C) CITIZEN PETITIONS.— 

14 ‘‘(i) IN GENERAL.—The Secretary 

15 may issue an administrative order under 

16 paragraph (1) in response to a citizen peti17 tion submitted under section 10.30 of title 

18 21, Code of Federal Regulations (or any 

19 successor regulation), subject to clause (ii). 

20 ‘‘(ii) EFFECT OF PETITION.—Nothing 

21 in clause (i) shall be construed to provide 

22 an alternative to, or otherwise supplant or 

23 supersede— 

24 ‘‘(I) the processes through which 

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1 tive order pursuant to paragraph (6); 

2 or 

3 ‘‘(II) the fee structure under sec4 tion 744L–1(a)(2). 

5 ‘‘(4) HEARINGS; JUDICIAL REVIEW.— 

6 ‘‘(A) IN GENERAL.—A person who partici7 pated in each level of formal dispute resolution 

8 under paragraph (3)(A)(iv)(III) of an adminis9 trative order with respect to a drug may re10 quest a hearing concerning a final administra11 tive order issued under paragraph (3)(A)(iv) 

12 with respect to such drug. Such person may 

13 submit a request for a hearing, which shall be 

14 based solely on the information in the adminis15 trative record, to the Secretary not later than 

16 30 calendar days after receiving notice of the 

17 final decision of the formal dispute resolution 

18 procedure. 

19 ‘‘(B) NO HEARING REQUIRED WITH RE20 SPECT TO ORDERS RELATING TO CERTAIN

21 DRUGS.—The Secretary is not required to pro22 vide notice and an opportunity for a hearing 

23 pursuant to paragraph (3)(A)(iv) if the final 

24 administrative order involved relates to a 

25 drug— 


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1 ‘‘(i) that is described in subclause (I) 

2 or (II) of subsection (b)(1)(B)(i); and 

3 ‘‘(ii) with respect to which no data 

4 relevant to the safety or effectiveness of 

5 such drug have been submitted to the ad6 ministrative record since the issuance of 

7 the most recent tentative final monograph 

8 relating to such drug (or, as applicable, 

9 since the deeming of such tentative final 

10 monograph as a final administrative order 

11 under paragraph (7)). 

12 ‘‘(C) HEARING PROCEDURES.— 

13 ‘‘(i) DENIAL OF REQUEST FOR HEAR14 ING.—If the Secretary determines that a 

15 request for a hearing under subparagraph 

16 (A) with respect to a final administrative 

17 order issued under paragraph (3)(A)(iv), 

18 does not establish the existence of a gen19 uine and substantial question of material 

20 fact, the Secretary may deny such request. 

21 In making such a determination, the Sec22 retary may consider only information and 

23 data that are based on relevant and reli24 able scientific principles and methodolo25 gies. 


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1 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

2 RELATED REQUESTS.—If more than one 

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

5 under subparagraph (A), the Secretary 

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

8 requests were granted may participate. 

9 ‘‘(iii) PRESIDING OFFICER.—The Sec10 retary shall appoint a presiding officer of 

11 a hearing requested under subparagraph 

12 (A) who— 

13 ‘‘(I) is not an employee of the 

14 Center for Drug Evaluation and Re15 search; and 

16 ‘‘(II) has not previously been in17 volved in the development of the appli18 cable administrative order or in the 

19 proceedings relating to that adminis20 trative order. 

21 ‘‘(iv) RIGHTS OF PARTIES TO HEAR22 ING.—The parties to a hearing requested 

23 under subparagraph (A) shall have the 

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1 amine witnesses presented by other parties. 

2 Where appropriate, the presiding officer 

3 may require that cross-examination by par4 ties representing substantially the same in5 terests be consolidated to promote effi6 ciency and avoid duplication. 

7 ‘‘(v) FINAL DECISION.—At the conclu8 sion of a hearing requested under subpara9 graph (A), the presiding officer of the 

10 hearing shall issue a decision containing 

11 findings of fact and conclusions of law. 

12 The decision of the presiding officer shall 

13 be final. The final decision may not take 

14 effect until the period under subparagraph 

15 (D)(ii) for submitting a request for judicial 

16 review of such decision expires. 

17 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN18 ISTRATIVE ORDER.— 

19 ‘‘(i) IN GENERAL.—The procedures 

20 described in section 505(h) shall apply 

21 with respect to judicial review of final ad22 ministrative orders issued under this sub23 section in the same manner and to the 

24 same extent as such section applies to an 

25 order described in such section except that 


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1 the judicial review shall be taken by filing 

2 in an appropriate district court of the 

3 United States in lieu of the appellate 

4 courts specified in such section. 

5 ‘‘(ii) TIME TO SUBMIT A REQUEST

6 FOR JUDICIAL REVIEW.—A person eligible 

7 to request a hearing under this paragraph 

8 and seeking judicial review of a final ad9 ministrative order issued under this sub10 section shall file a request for such review 

11 not later than 60 calendar days after the 

12 latest of— 

13 ‘‘(I) the date on which notice of 

14 such order is published; 

15 ‘‘(II) the date on which any hear16 ing with respect to such order is de17 nied under subparagraph (C)(i); 

18 ‘‘(III) the date on which a final 

19 decision is made following any hearing 

20 with respect to such order under sub21 paragraph (C)(v); or 

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

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


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1 ‘‘(5) EXPEDITED PROCEDURE WITH RESPECT

2 TO ADMINISTRATIVE ORDERS INITIATED BY THE

3 SECRETARY.— 

4 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

5 HEALTH.— 

6 ‘‘(i) IN GENERAL.—In the case of a 

7 determination by the Secretary that a 

8 monograph drug poses an imminent hazard 

9 to the public health, the Secretary may, 

10 after informally communicating with any 

11 sponsor that will be the subject of such de12 termination, not later than 48 hours before 

13 issuance of an order under this subpara14 graph— 

15 ‘‘(I) issue an interim final admin16 istrative order for such drug or com17 bination of drugs under paragraph 

18 (1), together with a detailed state19 ment of the reasons for such order; 

20 ‘‘(II) publish in the Federal Reg21 ister a notice of availability of such 

22 order; and 

23 ‘‘(III) provide for a public com24 ment period of at least 45 calendar 


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1 days after issuance of such interim 

2 final order. 

3 ‘‘(ii) NONDELEGATION.—The Sec4 retary may not delegate the authority to 

5 issue an interim final administrative order 

6 under this subparagraph. 

7 ‘‘(B) SAFETY LABELING CHANGES.— 

8 ‘‘(i) IN GENERAL.—In the case of a 

9 determination by the Secretary that a 

10 change in the labeling of a drug, class of 

11 drugs, or combination of drugs subject to 

12 this section is reasonably expected to miti13 gate a significant or unreasonable risk of 

14 a serious adverse event associated with use 

15 of the drug, the Secretary may, after infor16 mally communicating with any sponsor 

17 that will be the subject of such determina18 tion, not later than 48 hours before 

19 issuance of an order under this subpara20 graph— 

21 ‘‘(I) issue an interim final admin22 istrative order in accordance with 

23 paragraph (1) to require such change, 

24 together with a detailed statement of 

25 the reasons for such order; 


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

3 order; and 

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

6 days after issuance of such interim 

7 final order. 

8 ‘‘(ii) CONTENT OF ORDER.—An in9 terim final order issued under this sub10 paragraph with respect to the labeling of a 

11 drug may provide for new warnings and 

12 other information required for safe use of 

13 the drug. 

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

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

16 date specified by the Secretary, which date, in 

17 the case of an order under subparagraph (B) 

18 that includes changes to the packaging of the 

19 drug, shall not be earlier than the day after the 

20 date on which the comment period described in 

21 subparagraph (B)(i)(III) ends. 

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

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

24 the Secretary shall— 


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

2 with paragraph (1); 

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

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

6 ‘‘(iii) afford sponsors of drugs that 

7 will be subject to such an order the oppor8 tunity for formal dispute resolution up to 

9 the level of the Director of the Center for 

10 Drug Evaluation and Research, which ini11 tially shall be within 45 calendar days of 

12 the issuance of the order; and, for subse13 quent levels of appeal, within 30 calendar 

14 days of the prior decision. 

15 ‘‘(E) HEARINGS.— 

16 ‘‘(i) IN GENERAL.—A sponsor of a 

17 drug subject to a final order issued under 

18 subparagraph (D) who participated in each 

19 level of formal dispute resolution under 

20 subparagraph (D)(iii) may request a hear21 ing on such order. The provisions of sub22 paragraphs (A), (B), and (C) of paragraph 

23 (4) shall apply with respect to a hearing on 

24 such order in the same manner and to the 

25 same extent as such provisions apply with 


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1 respect to a hearing on an administrative 

2 order issued under paragraph (3)(A)(iv). 

3 ‘‘(ii) REFERENCES.—For purposes of 

4 a hearing under this subparagraph, the 

5 references in subparagraphs (A), (B), and 

6 (C) of paragraph (4)— 

7 ‘‘(I) to ‘each level of dispute reso8 lution under paragraph 

9 (3)(A)(iv)(III)’ shall be deemed to 

10 mean ‘each level of formal dispute res11 olution under subparagraph (D)(iii)’; 

12 and 

13 ‘‘(II) to ‘final administrative 

14 order issued under paragraph 

15 (3)(A)(iv)’ shall be deemed to mean 

16 ‘final order under subparagraph 

17 (D)(i)’. 

18 ‘‘(F) FINAL ORDER.—Not later than 1 

19 year after the date on which an interim final 

20 order is issued under subparagraph (A) or (B), 

21 the Secretary shall issue a final order in accord22 ance with paragraph (1) and complete any re23 quired hearing. 

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

25 issued pursuant to subparagraph (F) shall be 


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1 subject to judicial review in accordance with 

2 paragraph (4)(D). 

3 ‘‘(H) CLARIFICATION.—Paragraph (3) 

4 shall not apply to the orders issued under this 

5 paragraph. 

6 ‘‘(6) ADMINISTRATIVE ORDER INITIATED BY

7 REQUEST.— 

8 ‘‘(A) IN GENERAL.—In issuing an adminis9 trative order under paragraph (1) at the re10 quest of a requestor or a group of requestors 

11 with respect to certain drugs, classes of drugs, 

12 or combinations of drugs— 

13 ‘‘(i) the Secretary shall, after receiv14 ing a request under this subparagraph, de15 termine whether the request is sufficiently 

16 complete and formatted to permit a sub17 stantive review; 

18 ‘‘(ii) subject to subparagraph (D), if 

19 the Secretary determines that the request 

20 is sufficiently complete and formatted to 

21 permit a substantive review, the Secretary 

22 shall— 

23 ‘‘(I) file the request; and 

24 ‘‘(II) initiate proceedings with re25 spect to issuing an administrative 


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1 order in accordance with paragraphs 

2 (3) and (4); and 

3 ‘‘(iii) except as provided in subpara4 graph (D)(v), if the Secretary determines 

5 that a request does not meet the require6 ments for filing or is not sufficiently com7 plete or formatted to permit a substantive 

8 review, the requestor may elect that the 

9 Secretary file the request over protest, and 

10 the Secretary shall initiate proceedings to 

11 review the request in accordance with 

12 paragraph (3)(A). 

13 ‘‘(B) REQUEST TO INITIATE PRO14 CEEDINGS.— 

15 ‘‘(i) IN GENERAL.—A requestor seek16 ing an administrative order with respect to 

17 certain drugs, classes of drugs, or com18 binations of drugs, shall submit to the Sec19 retary a request to initiate proceedings for 

20 such order in the form and manner as 

21 specified by the Secretary. Such requestor 

22 may submit a request under this subpara23 graph for the issuance of an administrative 

24 order— 


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1 ‘‘(I) determining whether a drug 

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

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

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

6 subject of an approved application 

7 under section 505; or 

8 ‘‘(II) determining whether a 

9 change to a condition of use or a new 

10 condition of use of a drug is generally 

11 recognized as safe and effective within 

12 the meaning of section 201(p)(1), ex13 empt from section 503(b)(1), and not 

14 required to be the subject of an ap15 proved application under section 505, 

16 if such drug is— 

17 ‘‘(aa) described in sub18 section (b)(1)(A); or 

19 ‘‘(bb) described in sub20 section (b)(1)(B), but only if 

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1 fective within the meaning of sec2 tion 201(p)(1), which is filed by 

3 the Secretary under subpara4 graph (A)(ii)(I). 

5 The Secretary is not required to complete 

6 review of the request for a change de7 scribed in subclause (II) if the Secretary 

8 determines, in accordance with subpara9 graph (D), that there is an inadequate 

10 basis to find the drug is generally recog11 nized as safe and effective under para12 graph (1) and issues a final order an13 nouncing that determination. 

14 ‘‘(ii) WITHDRAWAL OF REQUEST.— 

15 The requestor may withdraw a request 

16 under this paragraph, according to the 

17 procedures established by the Secretary. 

18 Notwithstanding any other provision of 

19 this section, if such request is withdrawn, 

20 the Secretary shall cease proceedings 

21 under this subparagraph. 

22 ‘‘(C) PRODUCT DIFFERENTIATION.— 

23 ‘‘(i) IN GENERAL.—A final adminis24 trative order issued in response to a re25 quest under this paragraph shall have the 


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1 effect of providing the order requestor (or 

2 the licensees, assignees, or successors in 

3 interest of such requestor with respect to 

4 the subject of such order and listed under 

5 clause (v)) the exclusive right, for a period 

6 of 2 years, to market drugs under this sec7 tion incorporating changes described in 

8 clause (ii), subject to the limitations under 

9 clause (iv), and beginning on the date the 

10 requestor (or any such licensees, assignees, 

11 or successors in interest of such requestor) 

12 may lawfully market such drugs pursuant 

13 to the order. 

14 ‘‘(ii) CHANGES DESCRIBED.—A 

15 change described in this clause is a change 

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

17 which— 

18 ‘‘(I) permits a drug to contain an 

19 active ingredient not previously incor20 porated in a marketed drug listed in 

21 clause (iii); or 

22 ‘‘(II) permits a change in the 

23 conditions of use of a drug, for which 

24 human data studies conducted or 

25 sponsored by the requestor (or for 


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1 which the requestor has an exclusive 

2 right of reference) were essential to 

3 the issuance of such order. 

4 ‘‘(iii) MARKETED DRUGS.—The mar5 keted drugs listed in this clause are 

6 drugs— 

7 ‘‘(I) marketed in accordance with 

8 a final monograph issued under part 

9 330 of title 21, Code of Federal Regu10 lations (including conditions of use 

11 thereunder), as in effect on the day 

12 before the date of enactment of this 

13 section; 

14 ‘‘(II) marketed as category I or 

15 III in accordance with a tentative 

16 final monograph issued under such 

17 part 330 (including conditions of use 

18 and any applicable subsequent deter19 minations thereunder), as so in effect; 

20 ‘‘(III) marketed as category I in 

21 accordance with an advance notice of 

22 proposed rulemaking issued under 

23 such part 330 (including conditions of 

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1 terminations thereunder), as so in ef2 fect; 

3 ‘‘(IV) marketed in accordance 

4 with a final order issued under this 

5 section; or 

6 ‘‘(V) described in subsection 

7 (b)(1)(C), other than drugs subject to 

8 an active enforcement action under 

9 section 303. 

10 ‘‘(iv) LIMITATIONS ON PRODUCT DIF11 FERENTIATION.— 

12 ‘‘(I) ONLY ONE PERIOD.—Only 

13 one 2-year period may be granted per 

14 drug under clause (i) with respect to 

15 any change described in clause (ii). 

16 ‘‘(II) EXCLUSIONS.—No period 

17 of product differentiation under this 

18 subparagraph shall apply to changes 

19 to a drug that are— 

20 ‘‘(aa) ‘Tier 2’ changes de21 scribed in section 744L(14)(A); 

22 ‘‘(bb) safety-related changes 

23 described in section 744L– 

24 1(a)(2)(C), required under para25 graph (5), or any other change 


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1 the Secretary determines nec2 essary to ensure safe use; or 

3 ‘‘(cc) changes related to 

4 methods of testing safety or effi5 cacy. 

6 ‘‘(v) LISTING OF LICENSEES, ASSIGN7 EES, OR SUCCESSORS IN INTEREST.—The 

8 requestors of an order described in clause 

9 (i) shall, as applicable, submit to the Sec10 retary, at a time when a finished dosage 

11 form subject to such order is introduced or 

12 delivered for introduction into interstate 

13 commerce, a list of licensees, assignees, or 

14 successors in interest that have the exclu15 sive right described in such clause. 

16 ‘‘(vi) HUMAN DATA DEFINED.—For 

17 purposes of this subparagraph, the term 

18 ‘human data’ means data from clinical 

19 trials of safety or effectiveness, or phar20 macokinetics or bioavailability studies. 

21 ‘‘(D) INFORMATION REGARDING SAFE

22 NONPRESCRIPTION MARKETING AND USE AS A

23 CONDITION FOR FILING A GRASE REQUEST.— 

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

25 request under this paragraph that a drug 


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1 described in clause (ii) be generally recog2 nized as safe and effective, the Secretary— 

3 ‘‘(I) may file such request, if the 

4 request includes information specified 

5 under clause (iii) with respect to safe 

6 nonprescription marketing and use of 

7 such drug; or 

8 ‘‘(II) if the request fails to in9 clude information specified under 

10 clause (iii), shall refuse to file such re11 quest and may require that non12 prescription marketing of the drug be 

13 pursuant to a new drug application as 

14 described in clause (iv). 

15 ‘‘(ii) DRUG DESCRIBED.—A drug de16 scribed in this clause is a monograph drug 

17 that contains an active ingredient not pre18 viously incorporated in a drug— 

19 ‘‘(I) marketed in accordance with 

20 a final monograph issued under part 

21 330 of title 21, Code of Federal Regu22 lations (including conditions of use 

23 under such part), as in effect on the 

24 day before the date of enactment of 

25 this section; 


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1 ‘‘(II) marketed as category I in 

2 accordance with a tentative final 

3 monograph issued under part 330 of 

4 title 21, Code of Federal Regulations 

5 (including conditions of use and any 

6 applicable subsequent determinations 

7 under such part), as in effect on the 

8 day before the date of enactment of 

9 this section; or 

10 ‘‘(III) marketed in accordance 

11 with a final order issued under this 

12 section. 

13 ‘‘(iii) SUFFICIENT INFORMATION FOR

14 A THRESHOLD DEMONSTRATION OF NON15 PRESCRIPTION MARKETING AND USE.—In16 formation specified in this subparagraph, 

17 with respect to a request described in 

18 clause (i)(I), is— 

19 ‘‘(I) information sufficient for a 

20 threshold demonstration that the drug 

21 subject to such request has a 

22 verifiable history of being marketed 

23 and safely used by consumers in the 

24 United States as a nonprescription 


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1 drug under comparable conditions of 

2 use; 

3 ‘‘(II) if the drug has not been 

4 previously marketed in the United 

5 States as a nonprescription drug, in6 formation sufficient for a threshold 

7 demonstration that the drug was mar8 keted and safely used in a foreign 

9 country under conditions of marketing 

10 and use— 

11 ‘‘(aa) for such period of time 

12 as needed to provide reasonable 

13 assurances concerning the safe 

14 nonprescription use of the drug; 

15 and 

16 ‘‘(bb) during such period of 

17 time, was subject to sufficient 

18 monitoring by a regulatory body 

19 of any country listed in section 

20 802(b)(1)(A) or any country des21 ignated by the Secretary in ac22 cordance with section 

23 802(b)(1)(B); or 

24 ‘‘(III) if the Secretary determines 

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1 clause (I) or (II) is not needed to pro2 vide a threshold demonstration that 

3 the drug can be safely marketed and 

4 used as a nonprescription drug, other 

5 information the Secretary determines 

6 sufficient for such purposes. 

7 ‘‘(iv) MARKETING PURSUANT TO NEW

8 DRUG APPLICATION.—In the case of a re9 quest described in clause (i)(II), the drug 

10 subject to such request may be re-sub11 mitted for filing only if— 

12 ‘‘(I) the drug is marketed as a 

13 nonprescription drug, under condi14 tions of use comparable to the re15 quirements specified in the request, 

16 for such period of the time as the Sec17 retary determines appropriate (not to 

18 exceed 5 consecutive years) pursuant 

19 to an application approved under sec20 tion 505; and 

21 ‘‘(II) during such period of time, 

22 1,000,000 retail packages of the drug, 

23 or an equivalent quantity of the active 

24 ingredient or ingredients of such drug 

25 as determined by the Secretary, were 


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1 distributed for retail sale, as deter2 mined in such manner as the Sec3 retary may require. 

4 ‘‘(v) RULE OF APPLICATION.—If the 

5 Secretary refuses to file a request under 

6 this subparagraph, the requestor may not 

7 file over protest under subparagraph 

8 (A)(iii) unless the request involves a drug 

9 described in section 586(9) as in effect on 

10 January 1, 2017. 

11 ‘‘(7) TREATMENT OF FINAL AND TENTATIVE

12 FINAL MONOGRAPHS.—A final monograph or ten13 tative final monograph establishing requirements of 

14 use for a drug described in subsection (b)(1) shall 

15 be deemed to be a final administrative order under 

16 this subsection and may be amended, revoked, or 

17 otherwise modified in accordance with the proce18 dures of this subsection. 

19 ‘‘(8) PACKAGING.— 

20 ‘‘(A) IN GENERAL.—An administrative 

21 order issued under paragraph (3), (5)(A), or 

22 (6) may include requirements for the packaging 

23 of a drug, such as to promote use in accordance 

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1 tion, misuse, or abuse, including by pediatric 

2 populations. The Secretary shall consider, as 

3 appropriate, any such nonprescription drugs 

4 currently available, and the impact of the re5 moval of such drugs without such packaging 

6 and the changing of such packaging on patients 

7 and manufacturers when establishing such re8 quirements. 

9 ‘‘(B) EFFECTIVE DATE.—Requirements for 

10 packaging in an administrative order under 

11 paragraph (5)(B) shall not take effect earlier 

12 than the day after the date on which the com13 ment period under paragraph (5)(B)(i)(III) 

14 ends. 

15 ‘‘(C) CLARIFICATION.—This paragraph 

16 does not authorize the Secretary to require spe17 cial packaging or child-resistant packaging 

18 under the Poison Prevention Packaging Act of 

19 1970. 

20 ‘‘(d) PROCEDURE FOR MINOR CHANGES.— 

21 ‘‘(1) IN GENERAL.—Minor changes in the dos22 age form of a drug that is described in clause 

23 (i)(I)(aa)(CC) or (ii) of subsection (b)(1)(A) may be 

24 made by a requestor without the issuance of an ad25 ministrative order under subsection (c) if— 


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1 ‘‘(A) the requestor maintains information 

2 necessary to demonstrate that the change— 

3 ‘‘(i) will not affect the safety or effec4 tiveness of the drug; and 

5 ‘‘(ii) will not materially affect the ex6 tent of absorption or other exposure to the 

7 active ingredient in comparison to a suit8 able reference product; 

9 ‘‘(B) the requestor submits updated drug 

10 listing information for the drug in accordance 

11 with the requirements of section 510(j) within 

12 30 calendar days of the date on which the drug 

13 is first introduced into interstate commerce 

14 with the change; and 

15 ‘‘(C) the change is in conformity with the 

16 requirements of an applicable administrative 

17 order issued by the Secretary under paragraph 

18 (3). 

19 ‘‘(2) ADDITIONAL INFORMATION.— 

20 ‘‘(A) ACCESS TO RECORDS.—The requestor 

21 shall submit to the Secretary, under section 

22 704(a)(4), records requested by the Secretary 

23 related to a minor change within 15 business 

24 days of receiving such request, or such longer 

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1 quest shall be specific to a company and limited 

2 to the product and the minor change that 

3 prompted such request. Such request shall be 

4 specific to a company and limited to the prod5 uct and the minor change that prompted such 

6 request. 

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

8 Secretary determines that the information con9 tained in such records is not sufficient to dem10 onstrate that the change does not affect the 

11 safety or effectiveness of the drug or materially 

12 affect the extent of absorption or other expo13 sure to the active ingredient, the Secretary— 

14 ‘‘(i) may so inform the requestor of 

15 the drug in writing; and 

16 ‘‘(ii) provide the requestor of the drug 

17 with a reasonable opportunity to provide 

18 additional information. 

19 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN20 FORMATION.—If the requestor fails to provide 

21 such additional information within the pre22 scribed time, or if the Secretary determines that 

23 such additional information does not dem24 onstrate that the change does not affect the 

25 safety or effectiveness of the drug or materially 


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1 affect the extent of absorption or other expo2 sure to the active ingredient, the drug as modi3 fied is a new drug within the meaning of sec4 tion 201(p) and shall be deemed to be mis5 branded under section 502(ee). 

6 ‘‘(3) DETERMINING WHETHER CHANGE WILL

7 AFFECT SAFETY OR EFFECTIVENESS.— 

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

9 issue one or more administrative orders under 

10 subsection (c) specifying requirements for deter11 mining whether a minor change made by a re12 questor pursuant to this subsection will affect 

13 the safety or effectiveness of a drug or materi14 ally affect the extent of absorption or other ex15 posure to an active ingredient in the drug in 

16 comparison to a suitable reference product, to17 gether with guidance for applying those orders 

18 to specific dosage forms. 

19 ‘‘(B) STANDARD PRACTICES AND SPECIAL

20 NEEDS OF POPULATIONS.—The orders and 

21 guidance issued by the Secretary under sub22 paragraph (A) shall take into account relevant 

23 public standards and standard practices for 

24 evaluating the quality of drug products and 


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

3 ‘‘(e) INFORMATION SUBMITTED BY REQUESTORS.— 

4 ‘‘(1) CONFIDENTIAL INFORMATION.—Any infor5 mation, including reports of testing conducted on the 

6 drug or drugs involved, that is submitted by a re7 questor in connection with proceedings on an admin8 istrative order under this section (or any minor 

9 change under subsection (d)) and is a trade secret 

10 or confidential information subject to section 

11 552(b)(4) of title 5, United States Code, or section 

12 1905 of title 18, United States Code, shall not be 

13 disclosed to the public unless the requestor consents 

14 to that disclosure. 

15 ‘‘(2) PUBLIC AVAILABILITY LIMITATIONS.—The 

16 Secretary shall make available to the public any in17 formation (other than information contained in sub18 ject-level data sets, such as those derived from indi19 vidual case report forms) submitted by a requestor 

20 in support of a request under subsection (c)(6)(A) 

21 as of the date on which the proposed order is issued 

22 unless— 

23 ‘‘(A) the information pertains to pharma24 ceutical quality, unless such information is nec25 essary to establish standards under which a 


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1 drug is generally recognized as safe and effec2 tive within the meaning of section 201(p)(1); 

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

5 withdraws such request before the Secretary 

6 issues the proposed order in accordance with 

7 withdrawal procedures established by the Sec8 retary; or 

9 ‘‘(C) the Secretary otherwise obtains the 

10 information under subsection (d). 

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

13 (as the Secretary determines necessary, but not less fre14 quently than annually), and make available on the internet 

15 website of the Food and Drug Administration— 

16 ‘‘(1) a repository of each final administrative 

17 order and interim final order issued under sub18 section (c) that is in effect, including the complete 

19 text of the administrative order; and 

20 ‘‘(2) a listing of all administrative orders pro21 posed and under development on the initiative of the 

22 Secretary under this section, including— 

23 ‘‘(A) a brief description of the administra24 tive order; and 


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1 ‘‘(B) the expectations of the Secretary, for 

2 issuance of proposed administrative orders over 

3 a 3-year period. 

4 ‘‘(g) UPDATES TO DRUG LISTING INFORMATION.— 

5 A sponsor who makes a change to a drug other than a 

6 change in dosage form, which is in conformity with the 

7 requirements under subparagraph (A) or (B) of subsection 

8 (b)(1), shall not be subject to the requirements of sub9 section (c) or (d) with respect to such change, and shall 

10 submit updated drug listing information for the drug in 

11 accordance with the requirements of section 510(j) within 

12 30 calendar days of the date on which the drug, with the 

13 change, is first introduced or delivered for introduction 

14 into interstate commerce. 

15 ‘‘(h) APPROVALS UNDER SECTION 505.—This sec16 tion shall not be construed to preclude a sponsor of a drug 

17 or requestor from seeking or maintaining the approval of 

18 an application for such drug under subsection (b)(1), 

19 (b)(2), or (j) of section 505. A determination under this 

20 section that a drug is not subject to section 503(b)(1), 

21 is generally recognized as safe and effective within the 

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

23 section 201(p), shall constitute a finding of safety and ef24 fectiveness for purposes of section 505(b)(2) so that the 

25 applicant shall be required to submit only that information 


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1 needed to support the modification of the drug that is sub2 ject to the determination under this section. 

3 ‘‘(i) DEVELOPMENT ADVICE TO REQUESTORS OR

4 SPONSORS.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall estab6 lish procedures under which requestors may meet 

7 with appropriate officials of the Food and Drug Ad8 ministration to obtain advice on the studies and 

9 other information necessary to support requests 

10 under this section and other matters relevant to the 

11 regulation of monograph drugs and the development 

12 of new monograph drugs under this section. 

13 ‘‘(2) PARTICIPATION OF MULTIPLE SPON14 SORS.—The Secretary shall establish procedures to 

15 facilitate efficient participation by multiple reques16 tors in proceedings under this section, including pro17 vision for joint meetings with multiple requestors or 

18 with organizations nominated by requestors to rep19 resent their interests in a proceeding. 

20 ‘‘(3) PRIVATE MEETINGS WITH REQUESTORS.— 

21 The procedures established under this subsection 

22 shall include appropriate provision for confidential 

23 meetings with requestors with respect to discussion 

24 of matters involving confidential commercial infor25 mation or trade secrets. 


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

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

5 provided in this subsection, nothing in this section 

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

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

11 shall establish or modify such regulations by means 

12 of rulemaking in accordance with section 553 of title 

13 5, United States Code. 

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

16 ‘‘(A) IN GENERAL.—Section 310.545 of 

17 title 21, Code of Federal Regulations, as in ef18 fect on the date of enactment of this section, 

19 shall be deemed to be final administrative order 

20 under subsection (c). 

21 ‘‘(B) OTHER REGULATIONS.—Regulations 

22 establishing requirements for specific non23 prescription drugs marketed pursuant to this 

24 section that are in effect on the day before the 

25 date of enactment of this section (including 


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1 such requirements in parts 201, 250, and 330 

2 of title 21, Code of Federal Regulations), shall 

3 be deemed to be final administrative orders 

4 under subsection (c) only as such requirements 

5 apply to monograph drugs. 

6 ‘‘(C) EFFECTIVE DATE PERIOD.—Unless 

7 withdrawn or revised by the Secretary, the reg8 ulations under title 21 of the Code of Federal 

9 Regulations that are described in subparagraph 

10 (B) shall remain in effect with respect to drugs 

11 not subject to subparagraph (A), (B), (C), or 

12 (D) of subsection (b)(1). 

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

14 Secretary shall withdraw regulations establishing 

15 final monographs and the procedures governing the 

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

17 other relevant parts of title 21, Code of Federal 

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

19 of enactment of this Act), or make technical changes 

20 to such regulations to ensure conformity with appro21 priate terminology and cross references, to the ex22 tent needed to effectuate or harmonize the provi23 sions of this section. Notwithstanding subchapter II 

24 of chapter 5 of title 5, United States Code, any such 

25 withdrawal or technical amendments shall be made 


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1 without public notice and comment and be effective 

2 upon publication through notice in the Federal Reg3 ister (or upon such date as specified in such notice). 

4 ‘‘(k) GUIDANCE.— 

5 ‘‘(1) ISSUANCE.—The Secretary shall issue 

6 guidance that provides— 

7 ‘‘(A) the procedures and principles for for8 mal meetings between the Secretary and spon9 sors or requestors for drugs subject to this sec10 tion; 

11 ‘‘(B) the format and content of data sub12 missions to the Secretary under this section; 

13 ‘‘(C) the format of electronic submissions 

14 to the Secretary under this section; 

15 ‘‘(D) consolidated proceedings and the pro16 cedures for such proceedings where appropriate; 

17 and 

18 ‘‘(E) for minor changes in drugs, rec19 ommendations on how to comply with the re20 quirements in administrative orders issued 

21 under subsection (c)(3). 

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

23 this section shall be in an electronic format specified by 

24 the Secretary after providing a period for public comment. 


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1 ‘‘(m) INAPPLICABILITY OF PAPERWORK REDUCTION

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

3 not apply to collections of information made under this 

4 section.’’. 

5 SEC. 102. MISBRANDING. 

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

7 Act (21 U.S.C. 352) is amended by inserting after sub8 section (dd) the following: 

9 ‘‘(ee) If it is a nonprescription drug that is not the 

10 subject of an application approved under section 505, and 

11 does not comply with the requirements under section 

12 505G. 

13 ‘‘(ff) If it is a drug for which fees under section 

14 744L–1 have been assessed but have not been paid.’’. 

15 SEC. 103. CONFORMING AMENDMENTS TO THE SUNSCREEN 

16 INNOVATION ACT. 

17 (a) REVIEW OF NONPRESCRIPTION INGREDIENTS

18 SUBJECT TO SUNSCREEN INNOVATION ACT.— 

19 (1) PENDING SUNSCREEN INGREDIENTS.—Non20 prescription sunscreen active ingredients or combina21 tions of sunscreen active ingredients subject, on the 

22 date of enactment of this Act, to a proposed sun23 screen order, as defined in section 586(7) of the 

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

25 360fff(7)), shall— 


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1 (A) continue to be reviewed in accordance 

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

3 and Cosmetic Act (21 U.S.C. 360fff–3); or 

4 (B) be reviewed under section 505G of 

5 such Act upon notification of the Secretary by 

6 the sponsor that such sponsor elects to have 

7 such ingredient or combination of ingredients 

8 reviewed under such section 505G, and such 

9 proposed sunscreen order under such section 

10 586C shall be considered a proposed adminis11 trative order under section 505G(c)(3)(A)(ii) of 

12 such Act. 

13 (2) PENDING NONSUNSCREEN INGREDIENTS.— 

14 The sponsor of any application described in section 

15 586F of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 360fff–6) that was submitted to the Sec17 retary of Health and Human Services (referred to in 

18 this section as the ‘‘Secretary’’) pursuant to section 

19 330.14 of title 21, Code of Federal Regulations (as 

20 in effect on the day before the date of enactment of 

21 this Act), shall— 

22 (A) notify the Secretary that the sponsor 

23 elects to withdraw such application; or 

24 (B) notify the Secretary that the sponsor 

25 elects for such ingredient to be considered 


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1 under section 505G of the Federal Food, Drug, 

2 and Cosmetic Act, and any proposed order 

3 under such section 586F shall be considered a 

4 proposed administrative order under section 

5 505G(c)(3)(A)(ii) of that Act. 

6 (3) INGREDIENTS SUBMITTED AFTER THE

7 DATE OF ENACTMENT OF SECTION 506G.—Any in8 gredient that is eligible for review under section 

9 506G of the Federal Food, Drug, and Cosmetic Act 

10 and is submitted after the date of enactment of this 

11 Act shall be considered under that section. 

12 (b) MEETINGS REGARDING SUNSCREEN INGREDI13 ENTS.—Section 586C(b) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 360fff–3(b)) is amended by add15 ing at the end the following: 

16 ‘‘(11) MEETINGS WITH SPONSORS.—A sponsor 

17 may request an individual, confidential meeting to 

18 discuss the data requirements to support a general 

19 recognition of safety and effectiveness with respect 

20 to the subject of a pending sunscreen ingredient. 

21 The Secretary shall respond within 14 calendar days 

22 of the request and schedule such meeting within 45 

23 calendar days, or within such timeline as specified in 

24 the letters described in section 201 of the Over-the25 Counter Drug Safety, Innovation, and Reform Act. 


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1 If a sponsor requests more than one confidential 

2 meeting for the same request, the Secretary may 

3 refuse to grant an additional confidential meeting 

4 request if the Secretary determines such additional 

5 confidential meeting is not reasonably necessary for 

6 the sponsor to advance its request. The Secretary 

7 shall publish a post-meeting summary on the inter8 net website of the Food and Drug Administration of 

9 any confidential meeting that does not disclose con10 fidential business information. Such meetings shall 

11 not be required to comply with guidance issued by 

12 the Secretary addressing formal meetings for spon13 sors of human drug applications, as defined in sec14 tion 735.’’. 

15 (c) PRODUCT DIFFERENTIATION.—Section 586C of 

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

17 360fff–3) is amended by adding at the end the following: 

18 ‘‘(f) PRODUCT DIFFERENTIATION.— 

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

20 shall have the effect of providing the order requestor 

21 (or the licensees, assignees, or successors in interest 

22 of such requestor with respect to the subject of such 

23 request and listed under paragraph (5)) the exclu24 sive right, for a period of 2 years, to market a sun25 screen ingredient under this section incorporating 


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1 changes described in paragraph (2) subject to the 

2 limitations under paragraph (4), beginning on the 

3 date the requestor (or any licensees, assignees, or 

4 successors in interest of such requestor with respect 

5 to the subject of such request and listed under para6 graph (5)) may lawfully market such sunscreen in7 gredient pursuant to the order. 

8 ‘‘(2) CHANGES DESCRIBED.—A change de9 scribed in this paragraph is a change subject to an 

10 order specified in paragraph (1) that— 

11 ‘‘(A) permits a sunscreen to contain an ac12 tive ingredient not previously incorporated in a 

13 marketed sunscreen listed in paragraph (3); or 

14 ‘‘(B) permits a change in the conditions of 

15 use of a sunscreen ingredient, for which human 

16 data studies conducted or sponsored by the re17 questor (or for which the requestor has an ex18 clusive right of reference) were essential to the 

19 issuance of such order. 

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

21 sunscreen ingredients described this paragraph are 

22 sunscreen ingredients— 

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

24 monograph issued under part 330 of title 21, 

25 Code of Federal Regulations (including condiVerDate Sep 11 2014 23:58 Jan 18, 2018 Jkt 079200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S2315.IS S2315

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1 tions of use thereunder), as in effect on the day 

2 before the date of enactment of this section; 

3 ‘‘(B) marketed as category I or III in ac4 cordance with a tentative final monograph 

5 issued under such part 330 (including condi6 tions of use and any applicable subsequent de7 terminations thereunder), as so in effect; 

8 ‘‘(C) marketed as category I in accordance 

9 with an advance notice of proposed rulemaking 

10 issued under such part 330 (including condi11 tions of use and any applicable subsequent de12 terminations thereunder), as so in effect; or 

13 ‘‘(D) marketed in accordance with a final 

14 order issued under this section. 

15 ‘‘(4) LIMITATIONS ON PRODUCT DIFFERENTIA16 TION.— 

17 ‘‘(A) ONLY ONE PERIOD.—Only one 2-year 

18 period may be granted per ingredient under 

19 paragraph (1). 

20 ‘‘(B) EXCLUSIONS.—No period of product 

21 differentiation under this subparagraph shall 

22 apply to changes to a sunscreen that are— 

23 ‘‘(i) ‘Tier 2’ changes described in sec24 tion 744L(14)(A); 


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1 ‘‘(ii) safety-related changes described 

2 in section 744L–1(a)(2)(C), required under 

3 section 505G(c)(5), or any other change 

4 the Secretary determines necessary to en5 sure safe use; or 

6 ‘‘(iii) changes related to methods of 

7 testing safety or efficacy. 

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

9 SUCCESSORS IN INTEREST.—Requestors shall submit 

10 to the Secretary at the time when a final dosage 

11 form subject to such request is introduced or deliv12 ered for introduction into interstate commerce, a list 

13 of licensees, assignees, or successors in interest that 

14 have the exclusive right described in paragraph (1). 

15 ‘‘(6) HUMAN DATA DEFINED.—For purposes of 

16 this subsection, the term ‘human data’ means data 

17 from clinical trials of safety or effectiveness (includ18 ing actual use studies), pharmacokinetics, or bio19 availability.’’. 

20 (d) SUNSCREEN INNOVATION ACT AMENDMENTS.— 

21 Section 586C(e) of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 360fff–3(e)) is amended by striking para23 graph (3) and inserting the following: 

24 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC25 TION 505G.—A final sunscreen order shall be deemed 


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1 to be a final administrative order under section 

2 505G and subject to the applicable provisions under 

3 such section 505G, including with respect to amend4 ment of such order.’’. 

5 (e) PRECLUSION OF NEW SUNSCREEN SUBMISSIONS; 

6 OPTION TO TRANSFER SUBMISSIONS TO OTC MONO7 GRAPH ORDER PROCESS.— 

8 (1) SUNSET.—Beginning on the date of enact9 ment of this Act, section 586A of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 360fff–1) shall 

11 have no force or effect. 

12 (2) OPTION TO TRANSFER SUBMISSIONS TO OTC

13 MONOGRAPH ORDER PROCESS.— 

14 (A) IN GENERAL.—Any person who sub15 mitted a request described in subparagraph (B) 

16 may, at any time prior to the sunset of sub17 chapter I of chapter V of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 360fff et 

19 seq.) under section 586H of such Act, withdraw 

20 such request from the process under such sub21 chapter and resubmit such request as an order 

22 request under section 505G of such Act. 

23 (B) REQUESTS.—A request described in 

24 this subparagraph is— 


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1 (i) a request under section 586A of 

2 the Federal Food, Drug, and Cosmetic Act 

3 submitted before the date of enactment of 

4 this Act; or 

5 (ii) a pending request described in 

6 section 586(6). 

7 (f) TREATMENT OF AUTHORITY REGARDING FINAL8 IZATION OF SUNSCREEN MONOGRAPH.—Section 586E of 

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

10 360fff–5) is amended to read as follows: 

11 ‘‘SEC. 586E. SUNSCREEN ORDER. 

12 ‘‘(a) IN GENERAL.— 

13 ‘‘(1) REVISION OF FINAL SUNSCREEN ORDER.— 

14 Not later than November 26, 2019, the Secretary 

15 shall amend and revise the final administrative order 

16 concerning nonprescription sunscreen (referred to in 

17 this section as the ‘sunscreen order’) for which the 

18 substance, prior to the date of enactment of the 

19 Over-the-Counter Drug Safety, Innovation, and Re20 form Act, was represented by stayed regulations 

21 under part 352 of title 21, Code of Federal Regula22 tions. 

23 ‘‘(2) ISSUANCE OF REVISED SUNSCREEN

24 ORDER; EFFECTIVE DATE.—A revised sunscreen 

25 order described in paragraph (1) shall be— 


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1 ‘‘(A) effective not later than November 26, 

2 2019; and 

3 ‘‘(B) issued by the Secretary at least 30 

4 calendar days prior to such date. 

5 ‘‘(b) REPORTS.—If a revised sunscreen order issued 

6 under subsection (a) does not include provisions related 

7 to the effectiveness of various sun protection factor levels, 

8 and does not address all dosage forms known to the Sec9 retary to be used in sunscreens marketed in the United 

10 States without a new drug application approved under sec11 tion 505, the Secretary shall submit a report to the Com12 mittee on Health, Education, Labor, and Pensions of the 

13 Senate and the Committee on Energy and Commerce of 

14 the House of Representatives on the rationale for omission 

15 of such provisions from such order, and a plan and 

16 timeline to compile any information necessary to address 

17 such provisions through such order.’’. 

18 (g) SUNSET OF PROCESS UNDER SUNSCREEN INNO19 VATION ACT.—Subchapter I of chapter V of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 360fff et seq.), 

21 as amended by subsection (f), is further amended by in22 serting at the end the following new section: 

23 ‘‘SEC. 586H. SUNSET. 

24 ‘‘This subchapter shall no longer be effective upon 

25 the later of— 


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1 ‘‘(1) a final determination by the Secretary 

2 under this subchapter with respect to every request 

3 described in section 586A(b)(2) (other than any 

4 withdrawn requests and requests resubmitted as 

5 order requests under section 505G); or 

6 ‘‘(2) the effective date of the revised sunscreen 

7 order described in section 586E(a)(2).’’. 

8 SEC. 104. DRUGS EXCLUDED FROM OVER-THE-COUNTER 

9 REVIEW. 

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

11 amendments made by this Act) shall apply to any non12 prescription drug which was excluded by the Food and 

13 Drug Administration from the Over-the-Counter Drug Re14 view in accordance with the statement set out at page 

15 9466 of volume 37 of the Federal Register, published on 

16 May 11, 1972. 

17 (b) RULE OF CONSTRUCTION.—Nothing in this sec18 tion shall be construed to preclude or limit the applica19 bility of any provision of the Federal Food, Drug, and 

20 Cosmetic Act. 

21 SEC. 105. CONFORMING AMENDMENT. 

22 Section 751(d)(1) of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 379r(d)(1)) is amended— 

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


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1 (A) by striking ‘‘final regulation’’ and in2 serting ‘‘final order’’; and 

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

4 (2) in subparagraph (A), by striking ‘‘regula5 tion in effect’’ and inserting ‘‘regulation or order in 

6 effect’’. 

7 SEC. 106. ANNUAL UPDATE TO CONGRESS ON APPRO8 PRIATE PEDIATRIC INDICATION FOR CER9 TAIN COUGH AND COLD MONOGRAPH DRUGS. 

10 (a) IN GENERAL.—Not later than one year after the 

11 date of enactment of this Act and annually thereafter, the 

12 Secretary of Health and Human Services (referred to in 

13 this section as the ‘‘Secretary’’) shall submit to the Com14 mittee on Health, Education, Labor, and Pensions of the 

15 Senate and the Committee on Energy and Commerce of 

16 the House of Representatives a letter describing the 

17 progress of the Food and Drug Administration— 

18 (1) in evaluating the cough and cold monograph 

19 described in subsection (b) with respect to children 

20 under age 6; and 

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

22 monograph to address such children, through the ad23 ministrative order process under section 505G(b) of 

24 the Federal Food, Drug, and Cosmetic Act, as 

25 added by section 101. 


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1 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

2 The cough and cold monograph described in this sub3 section consists of the conditions under which nonprescrip4 tion drug products containing antitussive, expectorant, 

5 nasal decongestant, or antihistamine active ingredients (or 

6 combinations thereof) are generally recognized as safe and 

7 effective, as specified in part 341 of title 21, Code of Fed8 eral Regulations (as in effect on the day before the date 

9 of enactment of this Act), and included in an administra10 tive order deemed established under such section 505G(b) 

11 of the Federal Food, Drug, and Cosmetic Act. 

12 (c) DURATION OF AUTHORITY.—Subsection (a) shall 

13 have no force or effect beginning on the date on which 

14 the Secretary submits a letter under subsection (a) in 

15 which the Secretary indicates that the Food and Drug Ad16 ministration has completed its evaluation and revised, in 

17 a final administrative order, as applicable, the cough and 

18 cold monograph in accordance with this section. 

19 TITLE II—FEES RELATING TO 

20 MONOGRAPH DRUGS 

21 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

24 (b) FINDINGS.—The Congress finds that the fees au25 thorized by the amendments made in this title will be dediVerDate Sep 11 2014 23:58 Jan 18, 2018 Jkt 079200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\S2315.IS S2315

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1 cated toward the regulation of monograph drugs under 

2 section 505G of the Federal, Food, Drug, and Cosmetic 

3 Act, as set forth in the goals identified for purposes of 

4 such section, in the letters from the Secretary of Health 

5 and Human Services to the Chairman of the Committee 

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

7 and the Chairman of the Committee on Energy and Com8 merce of the House of Representatives, as set forth in the 

9 Congressional Record. 

10 SEC. 202. AUTHORITY TO ACCESS AND USE FEES. 

11 Subchapter C of chapter VII of the Federal Food, 

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

13 amended by adding at the end the following: 

14 ‘‘PART 10—FEES RELATING TO MONOGRAPH 

15 DRUGS 

16 ‘‘SEC. 744L. DEFINITIONS. 

17 ‘‘For purposes of this part: 

18 ‘‘(1) The term ‘affiliate’ means a business enti19 ty that has a relationship with a second business en20 tity if, directly or indirectly— 

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

22 the power to control, the other business entity; 

23 or 

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

25 to control, both of the business entities. 


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1 ‘‘(2) the term ‘contract manufacturing organi2 zation facility’ means a monograph drug facility 

3 where neither the owner of such manufacturing fa4 cility nor any affiliate of such owner or facility sells 

5 such monograph drug produced at such facility di6 rectly to wholesalers, retailers, or consumers in the 

7 United States. 

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

9 monograph drug activities’ means the expenses in 

10 connection with monograph drug activities for— 

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

12 and Drug Administration, contractors of the 

13 Food and Drug Administration, advisory com14 mittees, and costs related to such officers, em15 ployees, and committees and to contracts with 

16 such contractors; 

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

18 acquisition, maintenance, and repair of com19 puter resources; 

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

21 repair of facilities and acquisition, maintenance, 

22 and repair of fixtures, furniture, scientific 

23 equipment, and other necessary materials and 

24 supplies; and 


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1 ‘‘(D) collecting fees under section 744L–1 

2 and accounting for resources allocated for 

3 monograph drug activities. 

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

5 the unique number automatically generated by the 

6 Field Accomplishments and Compliance Tracking 

7 System of the Food and Drug Administration. 

8 ‘‘(5) The term ‘monograph drug’ shall have the 

9 meaning given the term under section 505G. 

10 ‘‘(6) The term ‘monograph drug activities’ 

11 means activities of the Secretary associated with 

12 monograph drug products and inspection of facilities 

13 associated with such products, including— 

14 ‘‘(A) the activities necessary for review and 

15 evaluation of monograph drugs and monograph 

16 drug order requests, including— 

17 ‘‘(i) orders proposing or finalizing ap18 plicable requirements of use for monograph 

19 drugs products; 

20 ‘‘(ii) orders affecting status regarding 

21 general recognition of safety and effective22 ness of a monograph drug ingredient or 

23 combination of ingredients under specified 

24 requirements of use; 


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1 ‘‘(iii) all monograph drug development 

2 and review activities, including intra-agen3 cy collaboration; 

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

6 drugs; 

7 ‘‘(v) development of product standards 

8 for products subject to review and evalua9 tion; 

10 ‘‘(vi) meetings regarding monograph 

11 drug activities; 

12 ‘‘(vii) review of labeling prior to 

13 issuance of orders related to monograph 

14 drugs or conditions of use; and 

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

17 ‘‘(B) inspections related to monograph 

18 drugs; 

19 ‘‘(C) monitoring of clinical and other re20 search conducted in connection with monograph 

21 drugs; 

22 ‘‘(D) safety activities with respect to mono23 graph drugs, including— 


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

3 drugs, including adverse event reports; 

4 ‘‘(ii) developing and using improved 

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

7 and 

8 ‘‘(iii) developing and using improved 

9 analytical tools to assess potential safety 

10 risks, including access to external data11 bases; and 

12 ‘‘(E) other activities necessary for imple13 mentation of section 505G. 

14 ‘‘(7)(A) The term ‘monograph drug facility’ 

15 means a foreign or domestic business or other enti16 ty— 

17 ‘‘(i) that is under one management, either 

18 direct or indirect; 

19 ‘‘(ii) at one geographic location or address 

20 engaged in manufacturing or processing a 

21 monograph drug in finished dosage form; 

22 ‘‘(iii) includes a finished dosage form man23 ufacturer facility or an affiliate thereof in a 

24 contractual relationship with a monograph drug 


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1 requestor or requestors to manufacture or proc2 ess monograph drugs; and 

3 ‘‘(iv) does not include a business or other 

4 entity whose only manufacturing or processing 

5 activities relate to— 

6 ‘‘(I) production of clinical research 

7 supplies; 

8 ‘‘(II) testing; or 

9 ‘‘(III) packaging of packaged final 

10 dosages in a manner that does not affect 

11 the drug. 

12 ‘‘(B) For purposes of subparagraph (A), sepa13 rate buildings or locations within close proximity are 

14 considered to be at 1 geographic location or address 

15 if the activities conducted in them are— 

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

17 enterprise; 

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

19 local management; and 

20 ‘‘(iii) under a single firm establishment 

21 identifier and capable of being inspected by the 

22 Food and Drug Administration during a single 

23 inspection. 

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

25 the definition of a facility under this paragraph but 


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1 for being under multiple management, the business 

2 or other entity is deemed to constitute multiple fa3 cilities, one per management entity, for purposes of 

4 this paragraph. 

5 ‘‘(8) The term ‘monograph drug meeting’ 

6 means any meeting regarding the content of a pro7 posed monograph drug order request. 

8 ‘‘(9) The term ‘monograph drug product’ 

9 means a monograph drug product that is marketed 

10 without an approved new drug application in accord11 ance with section 505G. 

12 ‘‘(10) The term ‘monograph drug order request’ 

13 means a request for an order under section 505G for 

14 the issuance of an administrative order for a change 

15 to the monograph drug product. 

16 ‘‘(11) The term ‘monograph drug requestor’ 

17 means an entity submitting a monograph drug order 

18 request or a monograph drug meeting request or any 

19 other inquiry relating to a request for an order or 

20 development of a monograph drug order request. 

21 ‘‘(12) The term ‘person’ includes an affiliate 

22 thereof. 

23 ‘‘(13) The term ‘Tier 1 monograph drug order 

24 request’ means any monograph drug order request 


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1 not determined to be a Tier 2 monograph drug order 

2 request. 

3 ‘‘(14)(A) The term ‘Tier 2 monograph drug 

4 order request’ means subject to subparagraph (B), a 

5 monograph drug order request for— 

6 ‘‘(i) the reordering of existing information 

7 in the drug facts label of a monograph drug 

8 product; 

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

10 other information section of the drug facts label 

11 of a nonprescription drug product, as limited by 

12 part 201.66(c)(7) of title 21, Code of Federal 

13 Regulations; 

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

15 section of the drug facts label of a nonprescrip16 tion drug product, if such changes conform to 

17 changes made pursuant to section 505G(d); 

18 ‘‘(iv) the standardization of the concentra19 tion or dose of a specific finalized ingredient 

20 within a particular finalized monograph; 

21 ‘‘(v) a change to ingredient nomenclature 

22 to align with nomenclature of a standards-set23 ting organization; or 


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1 ‘‘(vi) addition of an interchangeable term 

2 in accordance with part 330.1 of title 21, Code 

3 of Federal Regulations. 

4 ‘‘(B) The Secretary may, based on program im5 plementation experience or other factors found ap6 propriate by the Secretary, characterize any mono7 graph drug order request as a Tier 2 monograph 

8 drug order request (including recategorizing a re9 quest from Tier 1 to Tier 2) and publish such deter10 mination in a proposed order issued pursuant to sec11 tion 505G(c). 

12 ‘‘SEC. 744L–1. AUTHORITY TO ASSESS AND USE MONO13 GRAPH DRUG FEES. 

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

15 2018, the Secretary shall assess and collect fees in accord16 ance with this section as follows: 

17 ‘‘(1) FACILITY FEE.— 

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

19 subparagraph (B), each person that owns a fa20 cility identified as a monograph drug facility on 

21 December 31 of the fiscal year or at any time 

22 during the preceding 12-month period shall be 

23 assessed an annual fee for each such facility as 

24 determined under subsection (c). 

25 ‘‘(B) EXCEPTION.— 


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1 ‘‘(i) IN GENERAL.—A fee shall not be 

2 assessed under subparagraph (A) if the 

3 identified monograph drug facility has 

4 ceased all activities related to monograph 

5 drug products prior to the publication of 

6 the Notice under subparagraph C and has 

7 updated its registration to reflect such 

8 change under the requirements for drug 

9 establishment registration set forth in sec10 tion 510. 

11 ‘‘(ii) FEE AMOUNT.—The amount of 

12 the fee for a contract manufacturing orga13 nization facility shall be equal to two-thirds 

14 the amount of the fee for a monograph 

15 drug facility that is not a contract manu16 facturing organization facility. 

17 ‘‘(C) DUE DATE.—For each fiscal year, the 

18 facility fees required under subparagraph (A) 

19 shall be due on the later of— 

20 ‘‘(i) the first business day of April of 

21 such year; and 

22 ‘‘(ii) the first business day after the 

23 date of enactment of an appropriations Act 

24 providing for the collection and obligation 

25 of fees under this section for such year. 


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1 ‘‘(2) MONOGRAPH DRUG ORDER REQUEST

2 FEE.— 

3 ‘‘(A) IN GENERAL.—Each person that sub4 mits a monograph drug order request shall be 

5 subject to a fee for a monograph drug order re6 quest. The monograph drug order request fee 

7 under paragraph (2) shall be— 

8 ‘‘(i) for a Tier 1 monograph drug 

9 order request, $500,000, adjusted for in10 flation for the fiscal year (as determined 

11 under subsection (c)(1)); and 

12 ‘‘(ii) for a Tier 2 monograph drug 

13 order request other than a Tier 1 request, 

14 $100,000 adjusted for inflation for the fis15 cal year (as determined under subsection 

16 (c)(1)). 

17 ‘‘(B) DUE DATE.—The monograph drug 

18 order request fees required under subparagraph 

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

20 the monograph drug order request. 

21 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

22 CHANGES.—A person who is named as the re23 questor in a monograph drug order shall not be 

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

25 Secretary finds that the monograph drug order 


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1 request seeks to change the Drug Facts labeling 

2 of a monograph drug product in a way that 

3 would add to or strengthen— 

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

5 precaution; 

6 ‘‘(ii) a statement about risk associated 

7 with misuse or abuse; or 

8 ‘‘(iii) an instruction about dosage and 

9 administration that is intended to increase 

10 the safe use of the monograph drug prod11 uct. 

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

13 IS RECATEGORIZED AS A TIER 2 MONOGRAPH

14 DRUG ORDER REQUEST.—If the Secretary de15 termines that a monograph drug request ini16 tially characterized as Tier 1 should be re-char17 acterized as a Tier 2 monograph drug order re18 quest, and the requestor has paid a Tier 1 fee 

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

20 Secretary shall refund the requestor the dif21 ference between the Tier 1 and Tier 2 fees de22 termined under subparagraphs (A)(i) and 

23 (A)(ii), respectively. 

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

25 REFUSED FOR FILING OR WITHDRAWN BEFORE


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1 FILING.—The Secretary shall refund 75 percent 

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

3 order request that is refused for filing. 

4 ‘‘(F) FEES FOR ORDER REQUESTS PRE5 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

6 BEFORE FILING.—A monograph drug order re7 quest that was submitted but was refused for 

8 filing, or was withdrawn before being accepted 

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

10 fee under subparagraph (A) upon being resub11 mitted or filed over protest. 

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

13 WITHDRAWN.—If an order request is withdrawn 

14 after the order request was filed, the Secretary 

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

16 substantial work was performed on the order 

17 request after the application was filed. The Sec18 retary shall have the sole discretion to refund a 

19 fee or a portion of the fee under this subpara20 graph. A determination by the Secretary con21 cerning a refund under this paragraph shall not 

22 be reviewable. 

23 ‘‘(3) REFUNDS.— 

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

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1 graph (2), the Secretary shall not refund any 

2 fee paid under this subsection, except as pro3 vided in subparagraph (B). 

4 ‘‘(B) DISPUTES CONCERNING FEES.—To 

5 qualify for the return of a fee claimed to have 

6 been paid in error under this paragraph, a per7 son shall submit to the Secretary a written re8 quest justifying such return within 180 cal9 endar days after such fee was paid. 

10 ‘‘(b) FEE REVENUE AMOUNTS.— 

11 ‘‘(1) FISCAL YEAR 2018.—For fiscal year 2018, 

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

13 generate a total facility fee revenue amount equal to 

14 the sum of— 

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

16 year 2018 (as determined under paragraph 

17 (3)); 

18 ‘‘(B) the dollar amount equal to the oper19 ating reserve adjustment for the fiscal year, if 

20 applicable (as determined under subsection 

21 (c)(2)); and 

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

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

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

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1 section (a)(1) shall be established to generate a total 

2 facility fee revenue amount equal to the sum of— 

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

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

5 ‘‘(B) the dollar amount equal to the infla6 tion adjustment for the fiscal year (as deter7 mined under subsection (c)(1)); 

8 ‘‘(C) the dollar amount equal to the oper9 ating reserve adjustment for the fiscal year, if 

10 applicable (as determined under subsection 

11 (c)(2)); 

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

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

14 ‘‘(E) additional dollar amounts for each 

15 fiscal year as follows: 

16 ‘‘(i) $7,000,000 for fiscal year 2019. 

17 ‘‘(ii) $6,000,000 for fiscal year 2020. 

18 ‘‘(iii) $7,000,000 for fiscal year 2021. 

19 ‘‘(iv) $3,000,000 for fiscal year 2022. 

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

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

22 of the annual base revenue for a fiscal year shall 

23 be— 

24 ‘‘(A) for fiscal year 2018, $8,000,000; and 


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1 ‘‘(B) for fiscal years 2019 through 2022, 

2 the dollar amount of the total revenue amount 

3 established under this subsection for the pre4 vious fiscal year, not including any adjustments 

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

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

7 ‘‘(1) INFLATION ADJUSTMENT.— 

8 ‘‘(A) IN GENERAL.—For purposes of sub9 section (b)(2)(B), the dollar amount of the in10 flation adjustment to the annual base revenue 

11 for fiscal year 2019 and each subsequent fiscal 

12 year shall be equal to the product of— 

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

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

15 ‘‘(ii) the inflation adjustment percent16 age under subparagraph (B). 

17 ‘‘(B) INFLATION ADJUSTMENT PERCENT18 AGE.—The inflation adjustment percentage 

19 under this subparagraph for a fiscal year is 

20 equal to— 

21 ‘‘(i) for each of fiscal years 2019 

22 through 2020, the average annual percent 

23 change that occurred in the Consumer 

24 Price Index for urban consumers (Wash25 ington-Baltimore, DC–MD–VA–WV; Not 


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1 Seasonally Adjusted; All items; Annual 

2 Index) for the first 3 years of the pre3 ceding 4 years of available data; and 

4 ‘‘(ii) for each of fiscal years 2021 and 

5 2022, the sum of— 

6 ‘‘(I) the average annual percent 

7 change in the cost, per full-time equiv8 alent position of the Food and Drug 

9 Administration, of all personnel com10 pensation and benefits paid with re11 spect to such positions for the first 3 

12 years of the preceding 4 fiscal years, 

13 multiplied by the proportion of per14 sonnel compensation and benefits 

15 costs to total costs of monograph drug 

16 activities (as defined in subsection 

17 (a)) for the first 3 years of the pre18 ceding 4 fiscal years; and 

19 ‘‘(II) the average annual percent 

20 change that occurred in the Consumer 

21 Price Index for urban consumers 

22 (Washington-Baltimore, DC–MD–VA– 

23 WV; Not Seasonally Adjusted; All 

24 items; Annual Index) for the first 3 

25 years of the preceding 4 years of 


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1 available data multiplied by the pro2 portion of all costs other than per3 sonnel compensation and benefits 

4 costs to total costs of monograph drug 

5 activities for the first 3 years of the 

6 preceding 4 fiscal years. 

7 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

8 ‘‘(A) For fiscal year 2018 and subsequent 

9 fiscal years, the Secretary may, in addition to 

10 adjustments under paragraphs (1) and (2), fur11 ther increase the fee revenue and fees if such 

12 an adjustment is necessary to provide operating 

13 reserves of carryover user fees for monograph 

14 drug activities for the number of weeks speci15 fied in subparagraph (B). 

16 ‘‘(B) For each fiscal year the number of 

17 weeks of operating reserves shall be no more 

18 than— 

19 ‘‘(i) 3 weeks for fiscal year 2018; 

20 ‘‘(ii) 7 weeks for fiscal year 2019; 

21 ‘‘(iii) 10 weeks for fiscal year 2020; 

22 ‘‘(iv) 10 weeks for fiscal year 2021; 

23 and 

24 ‘‘(v) 10 weeks for fiscal year 2022. 


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1 ‘‘(C) If, for fiscal years 2019 through 

2 2022, the Secretary has carryover balances for 

3 monograph drug activities in excess of the num4 ber of weeks of such operating reserves speci5 fied in subparagraph B, the Secretary shall re6 duce such fee revenue and fees to provide for 

7 not more than the number of weeks of such op8 erating reserves specified in subparagraph 

9 (B)(v). 

10 ‘‘(D) If an adjustment under this para11 graph is made, the rationale for the amount of 

12 the increase or decrease (as applicable) in fee 

13 revenue and fees shall be contained in the an14 nual Federal Register notice under paragraph 

15 (5) establishing fee revenue and fees for the fis16 cal year involved. 

17 ‘‘(3) ADDITIONAL DIRECT COST ADJUST18 MENT.—The Secretary shall, in addition to adjust19 ments under paragraphs (1) and (2), further in20 crease the fee revenue by an amount equal to— 

21 ‘‘(A) 14,000,000 for fiscal year 2018; 

22 ‘‘(B) 7,000,000 for fiscal year 2019; 

23 ‘‘(C) 4,000,000 for fiscal year 2020; 

24 ‘‘(D) 3,000,000 for fiscal year 2021; and 

25 ‘‘(E) 3,000,000 for fiscal year 2022. 


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1 ‘‘(4) ANNUAL FEE SETTING.— 

2 ‘‘(A) FISCAL YEAR 2018.—The Secretary 

3 shall, not later than January 31, 2018— 

4 ‘‘(i) establish monograph drug facility 

5 fees for fiscal year 2018 under subsection 

6 (a)(1), based on the revenue amount for 

7 such year under subsection (b) and the ad8 justments provided under this subsection; 

9 and 

10 ‘‘(ii) publish such fee revenue and fa11 cility fees in the Federal Register. 

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

13 Secretary shall, not later than January 31 of 

14 each fiscal year that begins after September 30, 

15 2018, establish for each such fiscal year, based 

16 on the revenue amounts under subsection (b) 

17 and the adjustments provided under this sub18 section— 

19 ‘‘(i) monograph drug facility fees 

20 under subsection (a)(1); 

21 ‘‘(ii) monograph drug order request 

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

23 ‘‘(iii) publish such fee revenue, facility 

24 fees, and monograph drug order request 

25 fees in the Federal Register. 


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

2 that owns a monograph drug facility shall submit to the 

3 Secretary the information required under this subsection 

4 each year. Such information shall, for each fiscal year— 

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

6 for drug establishment registration set forth in sec7 tion 510; and 

8 ‘‘(2) include for each such facility, at a min9 imum, identification of the facility’s business oper10 ation as that of a monograph drug facility. 

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

12 ‘‘(1) IN GENERAL.—A monograph drug order 

13 request submitted by a person subject to fees under 

14 subsection (a) shall be considered incomplete and 

15 shall not be accepted for filing by the Secretary until 

16 all fees owed by such person have been paid. 

17 ‘‘(2) EFFECT ON ELIGIBILITY FOR MEET18 INGS.—If a monograph drug requestor fails to pay 

19 a fee assessed under subsection (a), the requestor 

20 shall be considered ineligible for monograph drug 

21 meetings. 

22 ‘‘(f) MONOGRAPH DRUG FACILITY FEE.—Failure to 

23 pay the fee under subsection (a)(1) within 20 calendar 

24 days of the due date as specified in subparagraph (D) of 

25 such subsection shall result in the Secretary placing the 


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1 facility on a publicly available arrears list until such fee 

2 has been paid. 

3 ‘‘(g) CREDITING AND AVAILABILITY OF FEES.— 

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

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

6 collected and available for obligation only to the ex7 tent and in the amount provided in advance in ap8 propriations Acts. Such fees are authorized to re9 main available until expended. Such sums as may be 

10 necessary may be transferred from the Food and 

11 Drug Administration salaries and expenses appro12 priation account without fiscal year limitation to 

13 such appropriation account for salaries and expenses 

14 with such fiscal year limitation. The sums trans15 ferred shall be available solely for monograph drug 

16 activities. 

17 ‘‘(2) COLLECTIONS AND APPROPRIATION

18 ACTS.— 

19 ‘‘(A) IN GENERAL.—Subject to subpara20 graphs (C) and (D), the fees authorized by this 

21 section shall be collected and available in each 

22 fiscal year in an amount not to exceed the 

23 amount specified in appropriation Acts, or oth24 erwise made available for obligation, for such 

25 fiscal year. 


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1 ‘‘(B) USE OF FEES AND LIMITATION.— 

2 The fees authorized by this section shall be 

3 available to defray increases in the costs of the 

4 resources allocated for monograph drug activi5 ties (including increases in such costs for an ad6 ditional number of full-time equivalent positions 

7 in the Department of Health and Human Serv8 ices to be engaged in such activities), only if the 

9 Secretary allocates for such purpose an amount 

10 for such fiscal year (excluding amounts from 

11 fees collecting under this section) no less than 

12 $12,000,000, multiplied by the adjustment fac13 tor applicable to the fiscal year involved. 

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

15 be considered to have met the requirements of 

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

17 funded by appropriations and allocated for the 

18 monograph drug activities are not more than 15 

19 percent below the level specified in such sub20 paragraph. 

21 ‘‘(D) FEE COLLECTION DURING FIRST

22 PROGRAM YEAR.—Until the date of enactment 

23 of an Act making appropriations and providing 

24 for the collection and obligation of fees under 

25 this section through September 30, 2018, for 


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1 the salaries and expenses account of the Food 

2 and Drug Administration, fees authorized by 

3 this section for fiscal year 2018 may be col4 lected and shall be credited to such account and 

5 remain available until expended. 

6 ‘‘(E) PROVISION FOR EARLY PAYMENTS IN

7 SUBSEQUENT YEARS.—Payment of fees author8 ized under this section for a fiscal year (after 

9 fiscal year 2018), prior to the due date for such 

10 fees, may be accepted by the Secretary in ac11 cordance with authority provided in advance in 

12 a prior year appropriations Act. 

13 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

14 For each of the fiscal years 2018 through 2022, 

15 there is authorized to be appropriated for fees under 

16 this section an amount equal to the total amount of 

17 fees assessed for such fiscal year under this section. 

18 ‘‘(h) COLLECTION OF UNPAID FEES.—In any case 

19 where the Secretary does not receive payment of a fee as20 sessed under subsection (a) within 30 calendar days after 

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

22 States Government subject to subchapter II of chapter 37 

23 of title 31. 

24 ‘‘(i) CONSTRUCTION.—This section may not be con25 strued to require that the number of full-time equivalent 


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1 positions in the Department of Health and Human Serv2 ices, for officers, employers, and advisory committees not 

3 engaged in monograph drug activities, be reduced to offset 

4 the number of officers, employees, and advisory commit5 tees so engaged. 

6 ‘‘SEC. 744L–2. REAUTHORIZATION; REPORTING REQUIRE7 MENTS. 

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

9 year 2018, and not later than 120 calendar days after the 

10 end of each fiscal year thereafter for which fees are col11 lected under this part, the Secretary shall prepare and 

12 submit to the Committee on the Health, Education, 

13 Labor, and Pensions of the Senate and the Committee on 

14 Energy and Commerce of the House of Representatives 

15 a report concerning the progress of the Food and Drug 

16 Administration in achieving the goals identified in the let17 ters described in section 201 of the during such fiscal year 

18 and the future plans of the Food and Drug Administration 

19 for meeting such goals. 

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

21 days after the end of fiscal year 2018 and each subsequent 

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

23 the Secretary shall prepare and submit to the Committee 

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

25 and the Committee on Energy and Commerce of the 


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1 House of Representatives a report on the implementation 

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

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

4 collected for such fiscal year. 

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

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

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

8 and Drug Administration. 

9 ‘‘(d) REAUTHORIZATION.— 

10 ‘‘(1) CONSULTATION.—In developing rec11 ommendations to present to Congress with respect to 

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

13 meeting the goals, for monograph drug activities for 

14 the first 5 fiscal years after fiscal year 2022, and for 

15 the reauthorization of this part for such fiscal years, 

16 the Secretary shall consult with— 

17 ‘‘(A) the Committee on Health, Education, 

18 Labor, and Pensions of the Senate; 

19 ‘‘(B) the Committee on Energy and Com20 merce of the House of Representatives; 

21 ‘‘(C) scientific and academic experts; 

22 ‘‘(D) health care professionals; 

23 ‘‘(E) representatives of patient and con24 sumer advocacy groups; and 

25 ‘‘(F) the regulated industry. 


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

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

6 committees specified in such paragraph; 

7 ‘‘(B) publish such recommendations in the 

8 Federal Register; 

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

10 days for the public to provide written comments 

11 on such recommendations; 

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

13 may present its views on such recommenda14 tions; and 

15 ‘‘(E) after consideration of such public 

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

18 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

19 Not later than January 15, 2022, the Secretary 

20 shall transmit to Congress the revised recommenda21 tions under paragraph (2), a summary of the views 

22 and comments received under such paragraph, and 

23 any changes made to the recommendations in re24 sponse to such views and comments.’’. 

Æ 


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