II 

Calendar No. 413 

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, Mr. CASEY, Mr. ALEXANDER, and Mrs. MURRAY) 

introduced the following bill; which was read twice and referred to the 

Committee on Health, Education, Labor, and Pensions 

MAY 14, 2018 

Reported by Mr. ALEXANDER, with an amendment 

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

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, 


sradovich on DSK3GMQ082PROD with BILLS
2 

•S 2315 RS

1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

4 Act’’. 

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

6 this Act is as follows: 

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. 

7 TITLE I—REGULATION OF 

8 NONPRESCRIPTION DRUGS 

9 SEC. 101. REGULATION OF CERTAIN NONPRESCRIPTION 

10 DRUGS THAT ARE MARKETED WITHOUT AN 

11 APPROVED NEW DRUG APPLICATION. 

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

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

14 355g) the following: 

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

16 DRUGS THAT ARE MARKETED WITHOUT AN 

17 APPROVED NEW DRUG APPLICATION. 

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


sradovich on DSK3GMQ082PROD with BILLS
3 

•S 2315 RS

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

2 ‘nonprescription drug’ means a drug, an active in3 gredient, or a combination of active ingredients that 

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

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

6 a person or group of persons marketing, manufac7 turing, processing, or developing a drug. 

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

9 person or group of persons marketing, manufac10 turing, or processing a drug and who has a listing 

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

12 ‘‘(b) MONOGRAPH DRUGS.— 

13 ‘‘(1) IN GENERAL.—With respect to a non14 prescription drug that, on or after the date of enact15 ment of the Over-the-Counter Drug Safety, Innova16 tion, and Reform Act, is introduced or delivered for 

17 introduction in interstate commerce for which an ap18 proved application under section 505 is not required, 

19 the following shall apply: 

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

21 be generally recognized as safe and effective 

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

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

24 ‘‘(i)(I) such drug is— 


sradovich on DSK3GMQ082PROD with BILLS
4 

•S 2315 RS

1 ‘‘(aa)(AA) subject to a final 

2 monograph issued under part 

3 330 of title 21, Code of Federal 

4 Regulations, as of the date of en5 actment of the Over-the-Counter 

6 Drug Safety, Innovation, and Re7 form Act; 

8 ‘‘(BB) in conformity with 

9 the conditions for nonprescription 

10 use of such monograph and the 

11 general requirements specified 

12 for nonprescription drugs, includ13 ing any modifications to those 

14 conditions made under sub15 sections (c), (d), and (j); and 

16 ‘‘(CC) except as permitted 

17 by an administrative order issued 

18 under subsection (c) or a minor 

19 change in the drug in conformity 

20 with subsection (d), is in a dos21 age form that has been used to a 

22 material extent and for a mate23 rial time within the meaning of 

24 section 201(p)(2); or 


sradovich on DSK3GMQ082PROD with BILLS
5 

•S 2315 RS

1 ‘‘(bb)(AA) the subject of a 

2 tentative final monograph that is 

3 the most recently applicable pro4 posal or determination issued 

5 under part 330 of title 21, Code 

6 of Federal Regulations, as of the 

7 date of enactment of the Over8 the-Counter Drug Safety, Inno9 vation, and Reform Act; 

10 ‘‘(BB) classified in category 

11 I for safety and effectiveness 

12 under such tentative final mono13 graph; 

14 ‘‘(CC) in conformity with 

15 the conditions for nonprescription 

16 use of such tentative final mono17 graph, any subsequent deter18 mination by the Secretary, and 

19 the general conditions for non20 prescription drugs, including any 

21 modifications of those conditions 

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

23 (j); and 

24 ‘‘(DD) except as permitted 

25 by an administrative order issued 


sradovich on DSK3GMQ082PROD with BILLS
6 

•S 2315 RS

1 under subsection (c) or a minor 

2 change in the drug in conformity 

3 with subsection (d), is in a dos4 age form that has been used to a 

5 material extent and for a mate6 rial time within the meaning of 

7 section 201(p)(2); or 

8 ‘‘(II) the active ingredient in such 

9 drug is in conformity with— 

10 ‘‘(aa) the requirements of a final 

11 administrative order issued under sub12 section (c) determining that such drug 

13 under the specific conditions of use is 

14 generally recognized as safe and effec15 tive within the meaning of section 

16 201(p)(1); and 

17 ‘‘(bb) the general requirements 

18 for nonprescription drugs, including 

19 any modifications of the requirements 

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

21 and 

22 ‘‘(ii) such drug is— 

23 ‘‘(I) not classified in Category II 

24 for safety or effectiveness under a ten25 tative final monograph; or 


sradovich on DSK3GMQ082PROD with BILLS
7 

•S 2315 RS

1 ‘‘(II) determined by the Sec2 retary to be not safe and effective, in 

3 a final monograph or preamble to a 

4 rule that is the most recently applica5 ble proposal or determination issued 

6 under part 330 of title 21, Code of 

7 Federal Regulations. 

8 ‘‘(B) A nonprescription drug may be intro9 duced into interstate commerce if such drug 

10 is— 

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

12 for safety or effectiveness under a tentative 

13 final monograph; or 

14 ‘‘(II) determined by the Secretary to 

15 be not safe and effective, in a final mono16 graph or preamble to a rule that is the 

17 most recently applicable proposal or deter18 mination issued under part 330 of title 21, 

19 Code of Federal Regulations; and 

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

21 final monograph that is the most recently 

22 applicable proposal or determination issued 

23 under part 330 of title 21, Code of Federal 

24 Regulations; 


sradovich on DSK3GMQ082PROD with BILLS
8 

•S 2315 RS

1 ‘‘(bb) classified in category III for 

2 safety or effectiveness in the preamble of a 

3 proposed rule establishing such tentative 

4 final monograph; 

5 ‘‘(cc) in conformity with the most re6 cently proposed or final rule establishing or 

7 proposing conditions of nonprescription use 

8 published in the Federal Register related 

9 to such tentative final monograph and the 

10 general requirements for nonprescription 

11 drugs, including any modifications of those 

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

13 and 

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

15 used to a material extent and for a mate16 rial time within the meaning of section 

17 201(p)(2); or 

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

19 monograph or advance notice of proposed 

20 rulemaking that is the most recently appli21 cable proposal or determination issued 

22 under part 330 of title 21, Code of Federal 

23 Regulations; 

24 ‘‘(bb) classified in category I for safe25 ty and effectiveness under such proposed 


sradovich on DSK3GMQ082PROD with BILLS
9 

•S 2315 RS

1 monograph or advance notice of proposed 

2 rulemaking; 

3 ‘‘(cc) in conformity with the most re4 cently proposed or final rule establishing or 

5 proposing conditions of nonprescription use 

6 published in the Federal Register related 

7 to such proposed monograph or advance 

8 notice of proposed rulemaking and the gen9 eral requirements for nonprescription 

10 drugs, including any modifications of those 

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

12 and 

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

14 used to a material extent and for a mate15 rial time within the meaning of section 

16 201(p)(2). 

17 ‘‘(C) A nonprescription drug may be intro18 duced into interstate commerce if— 

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

20 II for safety or effectiveness under a ten21 tative final monograph, or the Secretary 

22 has determined such drug not to be safe 

23 and effective in a final monograph or pre24 amble to a rule that is the most recently 

25 applicable proposal or determination issued 


sradovich on DSK3GMQ082PROD with BILLS
10 

•S 2315 RS

1 under part 330 of title 21, Code of Federal 

2 Regulations; and 

3 ‘‘(ii) the Secretary determines within 

4 6 months of the date of enactment of the 

5 Over-the-Counter Drug Safety, Innovation, 

6 and Reform Act, that it is in the interest 

7 of public health to extend the period dur8 ing which the drug may be marketed with9 out an approved new drug application 

10 under section 505. 

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

12 monograph for sunscreen drug products set 

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

14 Regulations (as published at volume 64 page 

15 27687 of the Federal Register), shall comply 

16 with the requirements of that monograph, ex17 cept that the testing requirements for effective18 ness and the provisions governing labeling shall 

19 be in accordance with section 201.327 of title 

20 21, Code of Federal Regulations (as in effect on 

21 the date of enactment of the Over-the-Counter 

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

23 such changes to those requirements as may be 

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


sradovich on DSK3GMQ082PROD with BILLS
11 

•S 2315 RS

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

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

3 subject to the requirements of section 505 if the 

4 drug is— 

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

6 (B), or (D) of paragraph (1) and not in con7 formity with subsection (d); 

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

9 order pursuant to subsection (c); or 

10 ‘‘(C) not a nonprescription sunscreen ac11 tive ingredient or combination of ingredients 

12 subject to a final sunscreen order, as defined in 

13 section 586(2). 

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

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

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

17 ‘‘(4) RULES OF CONSTRUCTION.— 

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

19 affect the treatment or status of a nonprescrip20 tion drug subject to section 505— 

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

22 the Over-the-Counter Drug Safety, Innova23 tion, and Reform Act, is marketed without 

24 an application approved under section 505; 

25 and 


sradovich on DSK3GMQ082PROD with BILLS
12 

•S 2315 RS

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

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

3 apply. 

4 ‘‘(B) APPLICABILITY OF OTHER PROVI5 SIONS.—Nothing in this paragraph shall be 

6 construed to preclude or limit the applicability 

7 of any other provision of this Act. 

8 ‘‘(C) NO EFFECT ON OTHER AUTHORI9 TIES.—Nothing in this subsection shall be con10 strued to prohibit the Secretary from issuing an 

11 order under this section finding a drug to be 

12 not generally recognized as safe and effective. 

13 ‘‘(c) ADMINISTRATIVE ORDERS.— 

14 ‘‘(1) IN GENERAL.— 

15 ‘‘(A) GENERALLY RECOGNIZED AS SAFE

16 AND EFFECTIVE.—The Secretary may, on the 

17 initiative of the Secretary or at the request of 

18 one or more requestors, issue an administrative 

19 order determining whether there are require20 ments under which a specific drug, class of 

21 such drugs, or combination of such drugs is de22 termined to be, after substantive review of evi23 dence— 

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


sradovich on DSK3GMQ082PROD with BILLS
13 

•S 2315 RS

1 ‘‘(ii) generally recognized as safe and 

2 effective within the meaning of section 

3 201(p)(1); and 

4 ‘‘(iii) not required to be approved 

5 under section 505. 

6 ‘‘(B) NOT GENERALLY RECOGNIZED AS

7 SAFE AND EFFECTIVE.—The Secretary shall 

8 issue an order determining that a drug is not 

9 generally recognized as safe and effective within 

10 the meaning of section 201(p)(1) for the speci11 fied requirements if, after substantive review of 

12 evidence, the Secretary determines that— 

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

14 is not generally recognized as safe and ef15 fective within the meaning of section 

16 201(p)(1); or 

17 ‘‘(ii) the evidence is inadequate to 

18 show that the drug is generally recognized 

19 as safe and effective within the meaning of 

20 section 201(p)(1). 

21 ‘‘(2) NONAPPLICATION OF CERTAIN REQUIRE22 MENTS.—The requirements of subchapter II of 

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

24 apply with respect to administrative orders issued 

25 under this section. 


sradovich on DSK3GMQ082PROD with BILLS
14 

•S 2315 RS

1 ‘‘(3) ADMINISTRATIVE ORDERS INITIATED BY

2 THE SECRETARY; CITIZEN PETITIONS.— 

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

4 paragraph (5), in issuing an administrative 

5 order under paragraph (1) on the initiative of 

6 the Secretary, the Secretary shall— 

7 ‘‘(i) not later than 2 business days be8 fore issuance of the proposed order, infor9 mally communicate the pending issuance of 

10 the order to sponsors of drugs that will be 

11 subject to such order; 

12 ‘‘(ii) after making any such informal 

13 communication— 

14 ‘‘(I) issue such a proposed ad15 ministrative order by publishing it on 

16 the internet website of the Food and 

17 Drug Administration and include in 

18 such order the reasons for the 

19 issuance of such order; and 

20 ‘‘(II) publish notice of availability 

21 of such proposed order in the Federal 

22 Register; 

23 ‘‘(iii) except as provided in subpara24 graph (B), provide for a public comment 


sradovich on DSK3GMQ082PROD with BILLS
15 

•S 2315 RS

1 period with respect to such proposed order 

2 of not less than 45 calendar days; and 

3 ‘‘(iv) if, after satisfying the require4 ments of clauses (i) through (iii), the Sec5 retary determines that it is appropriate to 

6 issue a final administrative order— 

7 ‘‘(I) issue the final administrative 

8 order, together with a detailed state9 ment of reasons, but such order shall 

10 not take effect until the time for re11 questing judicial review under para12 graph (4)(D)(ii) has expired; 

13 ‘‘(II) publish a notice of avail14 ability of such final administrative 

15 order in the Federal Register; 

16 ‘‘(III) afford requestors of prod17 ucts that will be subject to such order 

18 the opportunity for formal dispute 

19 resolution up to the level of the Direc20 tor of the Center for Drug Evaluation 

21 and Research, which initially shall be 

22 requested within 45 calendar days of 

23 the issuance of the order, and, for 

24 subsequent levels of appeal, within 30 


sradovich on DSK3GMQ082PROD with BILLS
16 

•S 2315 RS

1 calendar days of the prior decision; 

2 and 

3 ‘‘(IV) except with respect to 

4 drugs described in paragraph (4)(B), 

5 upon completion of the formal dispute 

6 resolution procedure, inform the per7 son or persons which sought such dis8 pute resolution of their right to re9 quest a hearing. 

10 ‘‘(B) SPECIAL REQUIREMENTS WITH RE11 SPECT TO CERTAIN MONOGRAPH DRUGS.— 

12 When issuing an administrative order under 

13 paragraph (1) on the initiative of the Secretary 

14 (except as provided under paragraph (5)) pro15 posing to determine that a monograph drug de16 scribed in subsection (b)(1)(B) is not generally 

17 recognized as safe and effective within the 

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

19 shall follow the procedures in subparagraph (A) 

20 except that— 

21 ‘‘(i) the proposed order shall include 

22 notice of— 

23 ‘‘(I) the general categories of 

24 data the Secretary has determined 

25 necessary to establish that the drug is 


sradovich on DSK3GMQ082PROD with BILLS
17 

•S 2315 RS

1 generally recognized as safe and effec2 tive within the meaning of section 

3 201(p)(1); and 

4 ‘‘(II) the format for submissions 

5 by interested persons; 

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

7 public comment period of not less than 180 

8 calendar days with respect to such pro9 posed order, except when the Secretary de10 termines, for good cause, that a shorter pe11 riod is in the interest of public health; and 

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

13 such comment period shall include a cer14 tification that the person has submitted all 

15 evidence created, obtained, or received by 

16 that person that is both within the cat17 egories of data identified in the proposed 

18 order and relevant to a determination as to 

19 whether the drug is generally recognized as 

20 safe and effective within the meaning of 

21 section 201(p)(1). 

22 ‘‘(C) CITIZEN PETITIONS.— 

23 ‘‘(i) IN GENERAL.—The Secretary 

24 may issue an administrative order under 

25 paragraph (1) in response to a citizen petiVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
18 

•S 2315 RS

1 tion submitted under section 10.30 of title 

2 21, Code of Federal Regulations (or any 

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

4 ‘‘(ii) EFFECT OF PETITION.—Nothing 

5 in clause (i) shall be construed to provide 

6 an alternative to, or otherwise supplant or 

7 supersede— 

8 ‘‘(I) the processes through which 

9 a requestor may seek an administra10 tive order pursuant to paragraph (6); 

11 or 

12 ‘‘(II) the fee structure under sec13 tion 744L–1(a)(2). 

14 ‘‘(4) HEARINGS; JUDICIAL REVIEW.— 

15 ‘‘(A) IN GENERAL.—A person who partici16 pated in each level of formal dispute resolution 

17 under paragraph (3)(A)(iv)(III) of an adminis18 trative order with respect to a drug may re19 quest a hearing concerning a final administra20 tive order issued under paragraph (3)(A)(iv) 

21 with respect to such drug. Such person may 

22 submit a request for a hearing, which shall be 

23 based solely on the information in the adminis24 trative record, to the Secretary not later than 

25 30 calendar days after receiving notice of the 


sradovich on DSK3GMQ082PROD with BILLS
19 

•S 2315 RS

1 final decision of the formal dispute resolution 

2 procedure. 

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

5 DRUGS.—The Secretary is not required to pro6 vide notice and an opportunity for a hearing 

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

8 administrative order involved relates to a 

9 drug— 

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

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

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

13 relevant to the safety or effectiveness of 

14 such drug have been submitted to the ad15 ministrative record since the issuance of 

16 the most recent tentative final monograph 

17 relating to such drug (or, as applicable, 

18 since the deeming of such tentative final 

19 monograph as a final administrative order 

20 under paragraph (7)). 

21 ‘‘(C) HEARING PROCEDURES.— 

22 ‘‘(i) DENIAL OF REQUEST FOR HEAR23 ING.—If the Secretary determines that a 

24 request for a hearing under subparagraph 

25 (A) with respect to a final administrative 


sradovich on DSK3GMQ082PROD with BILLS
20 

•S 2315 RS

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

2 does not establish the existence of a gen3 uine and substantial question of material 

4 fact, the Secretary may deny such request. 

5 In making such a determination, the Sec6 retary may consider only information and 

7 data that are based on relevant and reli8 able scientific principles and methodolo9 gies. 

10 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

11 RELATED REQUESTS.—If more than one 

12 request for a hearing is submitted with re13 spect to the same administrative order 

14 under subparagraph (A), the Secretary 

15 may direct that a single hearing be con16 ducted in which all persons whose hearing 

17 requests were granted may participate. 

18 ‘‘(iii) PRESIDING OFFICER.—The Sec19 retary shall appoint a presiding officer of 

20 a hearing requested under subparagraph 

21 (A) who— 

22 ‘‘(I) is not an employee of the 

23 Center for Drug Evaluation and Re24 search; and 


sradovich on DSK3GMQ082PROD with BILLS
21 

•S 2315 RS

1 ‘‘(II) has not previously been in2 volved in the development of the appli3 cable administrative order or in the 

4 proceedings relating to that adminis5 trative order. 

6 ‘‘(iv) RIGHTS OF PARTIES TO HEAR7 ING.—The parties to a hearing requested 

8 under subparagraph (A) shall have the 

9 right to present testimony, including testi10 mony of expert witnesses, and to cross-ex11 amine witnesses presented by other parties. 

12 Where appropriate, the presiding officer 

13 may require that cross-examination by par14 ties representing substantially the same in15 terests be consolidated to promote effi16 ciency and avoid duplication. 

17 ‘‘(v) FINAL DECISION.—At the conclu18 sion of a hearing requested under subpara19 graph (A), the presiding officer of the 

20 hearing shall issue a decision containing 

21 findings of fact and conclusions of law. 

22 The decision of the presiding officer shall 

23 be final. The final decision may not take 

24 effect until the period under subparagraph 


sradovich on DSK3GMQ082PROD with BILLS
22 

•S 2315 RS

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

2 review of such decision expires. 

3 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMIN4 ISTRATIVE ORDER.— 

5 ‘‘(i) IN GENERAL.—The procedures 

6 described in section 505(h) shall apply 

7 with respect to judicial review of final ad8 ministrative orders issued under this sub9 section in the same manner and to the 

10 same extent as such section applies to an 

11 order described in such section except that 

12 the judicial review shall be taken by filing 

13 in an appropriate district court of the 

14 United States in lieu of the appellate 

15 courts specified in such section. 

16 ‘‘(ii) TIME TO SUBMIT A REQUEST

17 FOR JUDICIAL REVIEW.—A person eligible 

18 to request a hearing under this paragraph 

19 and seeking judicial review of a final ad20 ministrative order issued under this sub21 section shall file a request for such review 

22 not later than 60 calendar days after the 

23 latest of— 

24 ‘‘(I) the date on which notice of 

25 such order is published; 


sradovich on DSK3GMQ082PROD with BILLS
23 

•S 2315 RS

1 ‘‘(II) the date on which any hear2 ing with respect to such order is de3 nied under subparagraph (C)(i); 

4 ‘‘(III) the date on which a final 

5 decision is made following any hearing 

6 with respect to such order under sub7 paragraph (C)(v); or 

8 ‘‘(IV) if no hearing is requested, 

9 the date on which the time for re10 questing a hearing expires. 

11 ‘‘(5) EXPEDITED PROCEDURE WITH RESPECT

12 TO ADMINISTRATIVE ORDERS INITIATED BY THE

13 SECRETARY.— 

14 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

15 HEALTH.— 

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

17 determination by the Secretary that a 

18 monograph drug poses an imminent hazard 

19 to the public health, the Secretary may, 

20 after informally communicating with any 

21 sponsor that will be the subject of such de22 termination, not later than 48 hours before 

23 issuance of an order under this subpara24 graph— 


sradovich on DSK3GMQ082PROD with BILLS
24 

•S 2315 RS

1 ‘‘(I) issue an interim final admin2 istrative order for such drug or com3 bination of drugs under paragraph 

4 (1), together with a detailed state5 ment of the reasons for such order; 

6 ‘‘(II) publish in the Federal Reg7 ister a notice of availability of such 

8 order; and 

9 ‘‘(III) provide for a public com10 ment period of at least 45 calendar 

11 days after issuance of such interim 

12 final order. 

13 ‘‘(ii) NONDELEGATION.—The Sec14 retary may not delegate the authority to 

15 issue an interim final administrative order 

16 under this subparagraph. 

17 ‘‘(B) SAFETY LABELING CHANGES.— 

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

19 determination by the Secretary that a 

20 change in the labeling of a drug, class of 

21 drugs, or combination of drugs subject to 

22 this section is reasonably expected to miti23 gate a significant or unreasonable risk of 

24 a serious adverse event associated with use 

25 of the drug, the Secretary may, after inforVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
25 

•S 2315 RS

1 mally communicating with any sponsor 

2 that will be the subject of such determina3 tion, not later than 48 hours before 

4 issuance of an order under this subpara5 graph— 

6 ‘‘(I) issue an interim final admin7 istrative order in accordance with 

8 paragraph (1) to require such change, 

9 together with a detailed statement of 

10 the reasons for such order; 

11 ‘‘(II) publish in the Federal Reg12 ister a notice of availability of such 

13 order; and 

14 ‘‘(III) provide for a public com15 ment period of at least 45 calendar 

16 days after issuance of such interim 

17 final order. 

18 ‘‘(ii) CONTENT OF ORDER.—An in19 terim final order issued under this sub20 paragraph with respect to the labeling of a 

21 drug may provide for new warnings and 

22 other information required for safe use of 

23 the drug. 

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

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


sradovich on DSK3GMQ082PROD with BILLS
26 

•S 2315 RS

1 date specified by the Secretary, which date, in 

2 the case of an order under subparagraph (B) 

3 that includes changes to the packaging of the 

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

5 date on which the comment period described in 

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

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

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

9 the Secretary shall— 

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

11 with paragraph (1); 

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

13 such final administrative order in the Fed14 eral Register; and 

15 ‘‘(iii) afford sponsors of drugs that 

16 will be subject to such an order the oppor17 tunity for formal dispute resolution up to 

18 the level of the Director of the Center for 

19 Drug Evaluation and Research, which ini20 tially shall be within 45 calendar days of 

21 the issuance of the order; and, for subse22 quent levels of appeal, within 30 calendar 

23 days of the prior decision. 

24 ‘‘(E) HEARINGS.— 


sradovich on DSK3GMQ082PROD with BILLS
27 

•S 2315 RS

1 ‘‘(i) IN GENERAL.—A sponsor of a 

2 drug subject to a final order issued under 

3 subparagraph (D) who participated in each 

4 level of formal dispute resolution under 

5 subparagraph (D)(iii) may request a hear6 ing on such order. The provisions of sub7 paragraphs (A), (B), and (C) of paragraph 

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

9 such order in the same manner and to the 

10 same extent as such provisions apply with 

11 respect to a hearing on an administrative 

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

13 ‘‘(ii) REFERENCES.—For purposes of 

14 a hearing under this subparagraph, the 

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

16 (C) of paragraph (4)— 

17 ‘‘(I) to ‘each level of dispute reso18 lution under paragraph 

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

20 mean ‘each level of formal dispute res21 olution under subparagraph (D)(iii)’; 

22 and 

23 ‘‘(II) to ‘final administrative 

24 order issued under paragraph 

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


sradovich on DSK3GMQ082PROD with BILLS
28 

•S 2315 RS

1 ‘final order under subparagraph 

2 (D)(i)’. 

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

4 year after the date on which an interim final 

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

6 the Secretary shall issue a final order in accord7 ance with paragraph (1) and complete any re8 quired hearing. 

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

10 issued pursuant to subparagraph (F) shall be 

11 subject to judicial review in accordance with 

12 paragraph (4)(D). 

13 ‘‘(H) CLARIFICATION.—Paragraph (3) 

14 shall not apply to the orders issued under this 

15 paragraph. 

16 ‘‘(6) ADMINISTRATIVE ORDER INITIATED BY

17 REQUEST.— 

18 ‘‘(A) IN GENERAL.—In issuing an adminis19 trative order under paragraph (1) at the re20 quest of a requestor or a group of requestors 

21 with respect to certain drugs, classes of drugs, 

22 or combinations of drugs— 

23 ‘‘(i) the Secretary shall, after receiv24 ing a request under this subparagraph, de25 termine whether the request is sufficiently 


sradovich on DSK3GMQ082PROD with BILLS
29 

•S 2315 RS

1 complete and formatted to permit a sub2 stantive review; 

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

4 the Secretary determines that the request 

5 is sufficiently complete and formatted to 

6 permit a substantive review, the Secretary 

7 shall— 

8 ‘‘(I) file the request; and 

9 ‘‘(II) initiate proceedings with re10 spect to issuing an administrative 

11 order in accordance with paragraphs 

12 (3) and (4); and 

13 ‘‘(iii) except as provided in subpara14 graph (D)(v), if the Secretary determines 

15 that a request does not meet the require16 ments for filing or is not sufficiently com17 plete or formatted to permit a substantive 

18 review, the requestor may elect that the 

19 Secretary file the request over protest, and 

20 the Secretary shall initiate proceedings to 

21 review the request in accordance with 

22 paragraph (3)(A). 

23 ‘‘(B) REQUEST TO INITIATE PRO24 CEEDINGS.— 


sradovich on DSK3GMQ082PROD with BILLS
30 

•S 2315 RS

1 ‘‘(i) IN GENERAL.—A requestor seek2 ing an administrative order with respect to 

3 certain drugs, classes of drugs, or com4 binations of drugs, shall submit to the Sec5 retary a request to initiate proceedings for 

6 such order in the form and manner as 

7 specified by the Secretary. Such requestor 

8 may submit a request under this subpara9 graph for the issuance of an administrative 

10 order— 

11 ‘‘(I) determining whether a drug 

12 is generally recognized as safe and ef13 fective within the meaning of section 

14 201(p)(1), exempt from section 

15 503(b)(1), and not required to be the 

16 subject of an approved application 

17 under section 505; or 

18 ‘‘(II) determining whether a 

19 change to a condition of use or a new 

20 condition of use of a drug is generally 

21 recognized as safe and effective within 

22 the meaning of section 201(p)(1), ex23 empt from section 503(b)(1), and not 

24 required to be the subject of an apVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
31 

•S 2315 RS

1 proved application under section 505, 

2 if such drug is— 

3 ‘‘(aa) described in sub4 section (b)(1)(A); or 

5 ‘‘(bb) described in sub6 section (b)(1)(B), but only if 

7 such requestor initiates such re8 quest in conjunction with a re9 quest for the Secretary to deter10 mine whether such drug is gen11 erally recognized as safe and ef12 fective within the meaning of sec13 tion 201(p)(1), which is filed by 

14 the Secretary under subpara15 graph (A)(ii)(I). 

16 The Secretary is not required to complete 

17 review of the request for a change de18 scribed in subclause (II) if the Secretary 

19 determines, in accordance with subpara20 graph (D), that there is an inadequate 

21 basis to find the drug is generally recog22 nized as safe and effective under para23 graph (1) and issues a final order an24 nouncing that determination. 


sradovich on DSK3GMQ082PROD with BILLS
32 

•S 2315 RS

1 ‘‘(ii) WITHDRAWAL OF REQUEST.— 

2 The requestor may withdraw a request 

3 under this paragraph, according to the 

4 procedures established by the Secretary. 

5 Notwithstanding any other provision of 

6 this section, if such request is withdrawn, 

7 the Secretary shall cease proceedings 

8 under this subparagraph. 

9 ‘‘(C) PRODUCT DIFFERENTIATION.— 

10 ‘‘(i) IN GENERAL.—A final adminis11 trative order issued in response to a re12 quest under this paragraph shall have the 

13 effect of providing the order requestor (or 

14 the licensees, assignees, or successors in 

15 interest of such requestor with respect to 

16 the subject of such order and listed under 

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

18 of 2 years, to market drugs under this sec19 tion incorporating changes described in 

20 clause (ii), subject to the limitations under 

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

22 requestor (or any such licensees, assignees, 

23 or successors in interest of such requestor) 

24 may lawfully market such drugs pursuant 

25 to the order. 


sradovich on DSK3GMQ082PROD with BILLS
33 

•S 2315 RS

1 ‘‘(ii) CHANGES DESCRIBED.—A 

2 change described in this clause is a change 

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

4 which— 

5 ‘‘(I) permits a drug to contain an 

6 active ingredient not previously incor7 porated in a marketed drug listed in 

8 clause (iii); or 

9 ‘‘(II) permits a change in the 

10 conditions of use of a drug, for which 

11 human data studies conducted or 

12 sponsored by the requestor (or for 

13 which the requestor has an exclusive 

14 right of reference) were essential to 

15 the issuance of such order. 

16 ‘‘(iii) MARKETED DRUGS.—The mar17 keted drugs listed in this clause are 

18 drugs— 

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 thereunder), as in effect on the day 

24 before the date of enactment of this 

25 section; 


sradovich on DSK3GMQ082PROD with BILLS
34 

•S 2315 RS

1 ‘‘(II) marketed as category I or 

2 III in accordance with a tentative 

3 final monograph issued under such 

4 part 330 (including conditions of use 

5 and any applicable subsequent deter6 minations thereunder), as so in effect; 

7 ‘‘(III) marketed as category I in 

8 accordance with an advance notice of 

9 proposed rulemaking issued under 

10 such part 330 (including conditions of 

11 use and any applicable subsequent de12 terminations thereunder), as so in ef13 fect; 

14 ‘‘(IV) marketed in accordance 

15 with a final order issued under this 

16 section; or 

17 ‘‘(V) described in subsection 

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

19 an active enforcement action under 

20 section 303. 

21 ‘‘(iv) LIMITATIONS ON PRODUCT DIF22 FERENTIATION.— 

23 ‘‘(I) ONLY ONE PERIOD.—Only 

24 one 2-year period may be granted per 


sradovich on DSK3GMQ082PROD with BILLS
35 

•S 2315 RS

1 drug under clause (i) with respect to 

2 any change described in clause (ii). 

3 ‘‘(II) EXCLUSIONS.—No period 

4 of product differentiation under this 

5 subparagraph shall apply to changes 

6 to a drug that are— 

7 ‘‘(aa) ‘Tier 2’ changes de8 scribed in section 744L(14)(A); 

9 ‘‘(bb) safety-related changes 

10 described in section 744L– 

11 1(a)(2)(C), required under para12 graph (5), or any other change 

13 the Secretary determines nec14 essary to ensure safe use; or 

15 ‘‘(cc) changes related to 

16 methods of testing safety or effi17 cacy. 

18 ‘‘(v) LISTING OF LICENSEES, ASSIGN19 EES, OR SUCCESSORS IN INTEREST.—The 

20 requestors of an order described in clause 

21 (i) shall, as applicable, submit to the Sec22 retary, at a time when a finished dosage 

23 form subject to such order is introduced or 

24 delivered for introduction into interstate 

25 commerce, a list of licensees, assignees, or 


sradovich on DSK3GMQ082PROD with BILLS
36 

•S 2315 RS

1 successors in interest that have the exclu2 sive right described in such clause. 

3 ‘‘(vi) HUMAN DATA DEFINED.—For 

4 purposes of this subparagraph, the term 

5 ‘human data’ means data from clinical 

6 trials of safety or effectiveness, or phar7 macokinetics or bioavailability studies. 

8 ‘‘(D) INFORMATION REGARDING SAFE

9 NONPRESCRIPTION MARKETING AND USE AS A

10 CONDITION FOR FILING A GRASE REQUEST.— 

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

12 request under this paragraph that a drug 

13 described in clause (ii) be generally recog14 nized as safe and effective, the Secretary— 

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

16 request includes information specified 

17 under clause (iii) with respect to safe 

18 nonprescription marketing and use of 

19 such drug; or 

20 ‘‘(II) if the request fails to in21 clude information specified under 

22 clause (iii), shall refuse to file such re23 quest and may require that non24 prescription marketing of the drug be 


sradovich on DSK3GMQ082PROD with BILLS
37 

•S 2315 RS

1 pursuant to a new drug application as 

2 described in clause (iv). 

3 ‘‘(ii) DRUG DESCRIBED.—A drug de4 scribed in this clause is a monograph drug 

5 that contains an active ingredient not pre6 viously incorporated in a drug— 

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 under such part), as in effect on the 

12 day before the date of enactment of 

13 this section; 

14 ‘‘(II) marketed as category I in 

15 accordance with a tentative final 

16 monograph issued under part 330 of 

17 title 21, Code of Federal Regulations 

18 (including conditions of use and any 

19 applicable subsequent determinations 

20 under such part), as in effect on the 

21 day before the date of enactment of 

22 this section; or 

23 ‘‘(III) marketed in accordance 

24 with a final order issued under this 

25 section. 


sradovich on DSK3GMQ082PROD with BILLS
38 

•S 2315 RS

1 ‘‘(iii) SUFFICIENT INFORMATION FOR

2 A THRESHOLD DEMONSTRATION OF NON3 PRESCRIPTION MARKETING AND USE.—In4 formation specified in this subparagraph, 

5 with respect to a request described in 

6 clause (i)(I), is— 

7 ‘‘(I) information sufficient for a 

8 threshold demonstration that the drug 

9 subject to such request has a 

10 verifiable history of being marketed 

11 and safely used by consumers in the 

12 United States as a nonprescription 

13 drug under comparable conditions of 

14 use; 

15 ‘‘(II) if the drug has not been 

16 previously marketed in the United 

17 States as a nonprescription drug, in18 formation sufficient for a threshold 

19 demonstration that the drug was mar20 keted and safely used in a foreign 

21 country under conditions of marketing 

22 and use— 

23 ‘‘(aa) for such period of time 

24 as needed to provide reasonable 

25 assurances concerning the safe 


sradovich on DSK3GMQ082PROD with BILLS
39 

•S 2315 RS

1 nonprescription use of the drug; 

2 and 

3 ‘‘(bb) during such period of 

4 time, was subject to sufficient 

5 monitoring by a regulatory body 

6 of any country listed in section 

7 802(b)(1)(A) or any country des8 ignated by the Secretary in ac9 cordance with section 

10 802(b)(1)(B); or 

11 ‘‘(III) if the Secretary determines 

12 that information described in sub13 clause (I) or (II) is not needed to pro14 vide a threshold demonstration that 

15 the drug can be safely marketed and 

16 used as a nonprescription drug, other 

17 information the Secretary determines 

18 sufficient for such purposes. 

19 ‘‘(iv) MARKETING PURSUANT TO NEW

20 DRUG APPLICATION.—In the case of a re21 quest described in clause (i)(II), the drug 

22 subject to such request may be re-sub23 mitted for filing only if— 

24 ‘‘(I) the drug is marketed as a 

25 nonprescription drug, under condiVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
40 

•S 2315 RS

1 tions of use comparable to the re2 quirements specified in the request, 

3 for such period of the time as the Sec4 retary determines appropriate (not to 

5 exceed 5 consecutive years) pursuant 

6 to an application approved under sec7 tion 505; and 

8 ‘‘(II) during such period of time, 

9 1,000,000 retail packages of the drug, 

10 or an equivalent quantity of the active 

11 ingredient or ingredients of such drug 

12 as determined by the Secretary, were 

13 distributed for retail sale, as deter14 mined in such manner as the Sec15 retary may require. 

16 ‘‘(v) RULE OF APPLICATION.—If the 

17 Secretary refuses to file a request under 

18 this subparagraph, the requestor may not 

19 file over protest under subparagraph 

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

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

22 January 1, 2017. 

23 ‘‘(7) TREATMENT OF FINAL AND TENTATIVE

24 FINAL MONOGRAPHS.—A final monograph or ten25 tative final monograph establishing requirements of 


sradovich on DSK3GMQ082PROD with BILLS
41 

•S 2315 RS

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

2 be deemed to be a final administrative order under 

3 this subsection and may be amended, revoked, or 

4 otherwise modified in accordance with the proce5 dures of this subsection. 

6 ‘‘(8) PACKAGING.— 

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

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

9 (6) may include requirements for the packaging 

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

11 with labeling, unit dose packaging, or require12 ments to prevent accidental overdose or inges13 tion, misuse, or abuse, including by pediatric 

14 populations. The Secretary shall consider, as 

15 appropriate, any such nonprescription drugs 

16 currently available, and the impact of the re17 moval of such drugs without such packaging 

18 and the changing of such packaging on patients 

19 and manufacturers when establishing such re20 quirements. 

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

22 packaging in an administrative order under 

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

24 than the day after the date on which the comVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
42 

•S 2315 RS

1 ment period under paragraph (5)(B)(i)(III) 

2 ends. 

3 ‘‘(C) CLARIFICATION.—This paragraph 

4 does not authorize the Secretary to require spe5 cial packaging or child-resistant packaging 

6 under the Poison Prevention Packaging Act of 

7 1970. 

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

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

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

12 made by a requestor without the issuance of an ad13 ministrative order under subsection (c) if— 

14 ‘‘(A) the requestor maintains information 

15 necessary to demonstrate that the change— 

16 ‘‘(i) will not affect the safety or effec17 tiveness of the drug; and 

18 ‘‘(ii) will not materially affect the ex19 tent of absorption or other exposure to the 

20 active ingredient in comparison to a suit21 able reference product; 

22 ‘‘(B) the requestor submits updated drug 

23 listing information for the drug in accordance 

24 with the requirements of section 510(j) within 

25 30 calendar days of the date on which the drug 


sradovich on DSK3GMQ082PROD with BILLS
43 

•S 2315 RS

1 is first introduced into interstate commerce 

2 with the change; and 

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

4 requirements of an applicable administrative 

5 order issued by the Secretary under paragraph 

6 (3). 

7 ‘‘(2) ADDITIONAL INFORMATION.— 

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

9 shall submit to the Secretary, under section 

10 704(a)(4), records requested by the Secretary 

11 related to a minor change within 15 business 

12 days of receiving such request, or such longer 

13 period as the Secretary may provide. Such re14 quest shall be specific to a company and limited 

15 to the product and the minor change that 

16 prompted such request. Such request shall be 

17 specific to a company and limited to the prod18 uct and the minor change that prompted such 

19 request. 

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

21 Secretary determines that the information con22 tained in such records is not sufficient to dem23 onstrate that the change does not affect the 

24 safety or effectiveness of the drug or materially 


sradovich on DSK3GMQ082PROD with BILLS
44 

•S 2315 RS

1 affect the extent of absorption or other expo2 sure to the active ingredient, the Secretary— 

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

4 the drug in writing; and 

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

6 with a reasonable opportunity to provide 

7 additional information. 

8 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN9 FORMATION.—If the requestor fails to provide 

10 such additional information within the pre11 scribed time, or if the Secretary determines that 

12 such additional information does not dem13 onstrate that the change does not affect the 

14 safety or effectiveness of the drug or materially 

15 affect the extent of absorption or other expo16 sure to the active ingredient, the drug as modi17 fied is a new drug within the meaning of sec18 tion 201(p) and shall be deemed to be mis19 branded under section 502(ee). 

20 ‘‘(3) DETERMINING WHETHER CHANGE WILL

21 AFFECT SAFETY OR EFFECTIVENESS.— 

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

23 issue one or more administrative orders under 

24 subsection (c) specifying requirements for deter25 mining whether a minor change made by a reVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00044 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
45 

•S 2315 RS

1 questor pursuant to this subsection will affect 

2 the safety or effectiveness of a drug or materi3 ally affect the extent of absorption or other ex4 posure to an active ingredient in the drug in 

5 comparison to a suitable reference product, to6 gether with guidance for applying those orders 

7 to specific dosage forms. 

8 ‘‘(B) STANDARD PRACTICES AND SPECIAL

9 NEEDS OF POPULATIONS.—The orders and 

10 guidance issued by the Secretary under sub11 paragraph (A) shall take into account relevant 

12 public standards and standard practices for 

13 evaluating the quality of drug products and 

14 may take into account special needs of popu15 lations, including children. 

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

17 ‘‘(1) CONFIDENTIAL INFORMATION.—Any infor18 mation, including reports of testing conducted on the 

19 drug or drugs involved, that is submitted by a re20 questor in connection with proceedings on an admin21 istrative order under this section (or any minor 

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

23 or confidential information subject to section 

24 552(b)(4) of title 5, United States Code, or section 

25 1905 of title 18, United States Code, shall not be 


sradovich on DSK3GMQ082PROD with BILLS
46 

•S 2315 RS

1 disclosed to the public unless the requestor consents 

2 to that disclosure. 

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

4 Secretary shall make available to the public any in5 formation (other than information contained in sub6 ject-level data sets, such as those derived from indi7 vidual case report forms) submitted by a requestor 

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

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

10 unless— 

11 ‘‘(A) the information pertains to pharma12 ceutical quality, unless such information is nec13 essary to establish standards under which a 

14 drug is generally recognized as safe and effec15 tive within the meaning of section 201(p)(1); 

16 ‘‘(B) the information is submitted in a re17 questor-initiated request, but the requestor 

18 withdraws such request before the Secretary 

19 issues the proposed order in accordance with 

20 withdrawal procedures established by the Sec21 retary; or 

22 ‘‘(C) the Secretary otherwise obtains the 

23 information under subsection (d). 

24 ‘‘(f) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR25 DERS.—The Secretary shall establish, maintain, update 


sradovich on DSK3GMQ082PROD with BILLS
47 

•S 2315 RS

1 (as the Secretary determines necessary, but not less fre2 quently than annually), and make available on the internet 

3 website of the Food and Drug Administration— 

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

5 order and interim final order issued under sub6 section (c) that is in effect, including the complete 

7 text of the administrative order; and 

8 ‘‘(2) a listing of all administrative orders pro9 posed and under development on the initiative of the 

10 Secretary under this section, including— 

11 ‘‘(A) a brief description of the administra12 tive order; and 

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

14 issuance of proposed administrative orders over 

15 a 3-year period. 

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

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

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

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

20 (b)(1), shall not be subject to the requirements of sub21 section (c) or (d) with respect to such change, and shall 

22 submit updated drug listing information for the drug in 

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

24 30 calendar days of the date on which the drug, with the 


sradovich on DSK3GMQ082PROD with BILLS
48 

•S 2315 RS

1 change, is first introduced or delivered for introduction 

2 into interstate commerce. 

3 ‘‘(h) APPROVALS UNDER SECTION 505.—This sec4 tion shall not be construed to preclude a sponsor of a drug 

5 or requestor from seeking or maintaining the approval of 

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

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

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

9 is generally recognized as safe and effective within the 

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

11 section 201(p), shall constitute a finding of safety and ef12 fectiveness for purposes of section 505(b)(2) so that the 

13 applicant shall be required to submit only that information 

14 needed to support the modification of the drug that is sub15 ject to the determination under this section. 

16 ‘‘(i) DEVELOPMENT ADVICE TO REQUESTORS OR

17 SPONSORS.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall estab19 lish procedures under which requestors may meet 

20 with appropriate officials of the Food and Drug Ad21 ministration to obtain advice on the studies and 

22 other information necessary to support requests 

23 under this section and other matters relevant to the 

24 regulation of monograph drugs and the development 

25 of new monograph drugs under this section. 


sradovich on DSK3GMQ082PROD with BILLS
49 

•S 2315 RS

1 ‘‘(2) PARTICIPATION OF MULTIPLE SPON2 SORS.—The Secretary shall establish procedures to 

3 facilitate efficient participation by multiple reques4 tors in proceedings under this section, including pro5 vision for joint meetings with multiple requestors or 

6 with organizations nominated by requestors to rep7 resent their interests in a proceeding. 

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

9 The procedures established under this subsection 

10 shall include appropriate provision for confidential 

11 meetings with requestors with respect to discussion 

12 of matters involving confidential commercial infor13 mation or trade secrets. 

14 ‘‘(j) EFFECT ON EXISTING REGULATIONS GOV15 ERNING NONPRESCRIPTION DRUGS.— 

16 ‘‘(1) REGULATIONS OF GENERAL APPLICA17 BILITY TO NONPRESCRIPTION DRUGS.—Except as 

18 provided in this subsection, nothing in this section 

19 supersedes regulations establishing general require20 ments for nonprescription drugs, including regula21 tions of general applicability contained in parts 201, 

22 250, and 330 of title 21, Code of Federal Regula23 tions, or any successor regulations. The Secretary 

24 shall establish or modify such regulations by means 


sradovich on DSK3GMQ082PROD with BILLS
50 

•S 2315 RS

1 of rulemaking in accordance with section 553 of title 

2 5, United States Code. 

3 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE4 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

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

6 title 21, Code of Federal Regulations, as in ef7 fect on the date of enactment of this section, 

8 shall be deemed to be final administrative order 

9 under subsection (c). 

10 ‘‘(B) OTHER REGULATIONS.—Regulations 

11 establishing requirements for specific non12 prescription drugs marketed pursuant to this 

13 section that are in effect on the day before the 

14 date of enactment of this section (including 

15 such requirements in parts 201, 250, and 330 

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

17 be deemed to be final administrative orders 

18 under subsection (c) only as such requirements 

19 apply to monograph drugs. 

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

21 withdrawn or revised by the Secretary, the reg22 ulations under title 21 of the Code of Federal 

23 Regulations that are described in subparagraph 

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


sradovich on DSK3GMQ082PROD with BILLS
51 

•S 2315 RS

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

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

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

4 Secretary shall withdraw regulations establishing 

5 final monographs and the procedures governing the 

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

7 other relevant parts of title 21, Code of Federal 

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

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

10 to such regulations to ensure conformity with appro11 priate terminology and cross references, to the ex12 tent needed to effectuate or harmonize the provi13 sions of this section. Notwithstanding subchapter II 

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

15 withdrawal or technical amendments shall be made 

16 without public notice and comment and be effective 

17 upon publication through notice in the Federal Reg18 ister (or upon such date as specified in such notice). 

19 ‘‘(k) GUIDANCE.— 

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

21 guidance that provides— 

22 ‘‘(A) the procedures and principles for for23 mal meetings between the Secretary and spon24 sors or requestors for drugs subject to this sec25 tion; 


sradovich on DSK3GMQ082PROD with BILLS
52 

•S 2315 RS

1 ‘‘(B) the format and content of data sub2 missions to the Secretary under this section; 

3 ‘‘(C) the format of electronic submissions 

4 to the Secretary under this section; 

5 ‘‘(D) consolidated proceedings and the pro6 cedures for such proceedings where appropriate; 

7 and 

8 ‘‘(E) for minor changes in drugs, rec9 ommendations on how to comply with the re10 quirements in administrative orders issued 

11 under subsection (c)(3). 

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

13 this section shall be in an electronic format specified by 

14 the Secretary after providing a period for public comment. 

15 ‘‘(m) INAPPLICABILITY OF PAPERWORK REDUCTION

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

17 not apply to collections of information made under this 

18 section.’’. 

19 SEC. 102. MISBRANDING. 

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

21 Act (21 U.S.C. 352) is amended by inserting after sub22 section (dd) the following: 

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

24 subject of an application approved under section 505, and 


sradovich on DSK3GMQ082PROD with BILLS
53 

•S 2315 RS

1 does not comply with the requirements under section 

2 505G. 

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

4 744L–1 have been assessed but have not been paid.’’. 

5 SEC. 103. CONFORMING AMENDMENTS TO THE SUNSCREEN 

6 INNOVATION ACT. 

7 (a) REVIEW OF NONPRESCRIPTION INGREDIENTS

8 SUBJECT TO SUNSCREEN INNOVATION ACT.— 

9 (1) PENDING SUNSCREEN INGREDIENTS.—Non10 prescription sunscreen active ingredients or combina11 tions of sunscreen active ingredients subject, on the 

12 date of enactment of this Act, to a proposed sun13 screen order, as defined in section 586(7) of the 

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

15 360fff(7)), shall— 

16 (A) continue to be reviewed in accordance 

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

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

19 (B) be reviewed under section 505G of 

20 such Act upon notification of the Secretary by 

21 the sponsor that such sponsor elects to have 

22 such ingredient or combination of ingredients 

23 reviewed under such section 505G, and such 

24 proposed sunscreen order under such section 

25 586C shall be considered a proposed adminisVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
54 

•S 2315 RS

1 trative order under section 505G(c)(3)(A)(ii) of 

2 such Act. 

3 (2) PENDING NONSUNSCREEN INGREDIENTS.— 

4 The sponsor of any application described in section 

5 586F of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 360fff–6) that was submitted to the Sec7 retary of Health and Human Services (referred to in 

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

9 330.14 of title 21, Code of Federal Regulations (as 

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

11 this Act), shall— 

12 (A) notify the Secretary that the sponsor 

13 elects to withdraw such application; or 

14 (B) notify the Secretary that the sponsor 

15 elects for such ingredient to be considered 

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

17 and Cosmetic Act, and any proposed order 

18 under such section 586F shall be considered a 

19 proposed administrative order under section 

20 505G(c)(3)(A)(ii) of that Act. 

21 (3) INGREDIENTS SUBMITTED AFTER THE

22 DATE OF ENACTMENT OF SECTION 506G.—Any in23 gredient that is eligible for review under section 

24 506G of the Federal Food, Drug, and Cosmetic Act 


sradovich on DSK3GMQ082PROD with BILLS
55 

•S 2315 RS

1 and is submitted after the date of enactment of this 

2 Act shall be considered under that section. 

3 (b) MEETINGS REGARDING SUNSCREEN INGREDI4 ENTS.—Section 586C(b) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 360fff–3(b)) is amended by add6 ing at the end the following: 

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

8 may request an individual, confidential meeting to 

9 discuss the data requirements to support a general 

10 recognition of safety and effectiveness with respect 

11 to the subject of a pending sunscreen ingredient. 

12 The Secretary shall respond within 14 calendar days 

13 of the request and schedule such meeting within 45 

14 calendar days, or within such timeline as specified in 

15 the letters described in section 201 of the Over-the16 Counter Drug Safety, Innovation, and Reform Act. 

17 If a sponsor requests more than one confidential 

18 meeting for the same request, the Secretary may 

19 refuse to grant an additional confidential meeting 

20 request if the Secretary determines such additional 

21 confidential meeting is not reasonably necessary for 

22 the sponsor to advance its request. The Secretary 

23 shall publish a post-meeting summary on the inter24 net website of the Food and Drug Administration of 

25 any confidential meeting that does not disclose conVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00055 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
56 

•S 2315 RS

1 fidential business information. Such meetings shall 

2 not be required to comply with guidance issued by 

3 the Secretary addressing formal meetings for spon4 sors of human drug applications, as defined in sec5 tion 735.’’. 

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

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

8 360fff–3) is amended by adding at the end the following: 

9 ‘‘(f) PRODUCT DIFFERENTIATION.— 

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

11 shall have the effect of providing the order requestor 

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

13 of such requestor with respect to the subject of such 

14 request and listed under paragraph (5)) the exclu15 sive right, for a period of 2 years, to market a sun16 screen ingredient under this section incorporating 

17 changes described in paragraph (2) subject to the 

18 limitations under paragraph (4), beginning on the 

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

20 successors in interest of such requestor with respect 

21 to the subject of such request and listed under para22 graph (5)) may lawfully market such sunscreen in23 gredient pursuant to the order. 


sradovich on DSK3GMQ082PROD with BILLS
57 

•S 2315 RS

1 ‘‘(2) CHANGES DESCRIBED.—A change de2 scribed in this paragraph is a change subject to an 

3 order specified in paragraph (1) that— 

4 ‘‘(A) permits a sunscreen to contain an ac5 tive ingredient not previously incorporated in a 

6 marketed sunscreen listed in paragraph (3); or 

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

8 use of a sunscreen ingredient, for which human 

9 data studies conducted or sponsored by the re10 questor (or for which the requestor has an ex11 clusive right of reference) were essential to the 

12 issuance of such order. 

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

14 sunscreen ingredients described this paragraph are 

15 sunscreen ingredients— 

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

17 monograph issued under part 330 of title 21, 

18 Code of Federal Regulations (including condi19 tions of use thereunder), as in effect on the day 

20 before the date of enactment of this section; 

21 ‘‘(B) marketed as category I or III in ac22 cordance with a tentative final monograph 

23 issued under such part 330 (including condi24 tions of use and any applicable subsequent de25 terminations thereunder), as so in effect; 


sradovich on DSK3GMQ082PROD with BILLS
58 

•S 2315 RS

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

2 with an advance notice of proposed rulemaking 

3 issued under such part 330 (including condi4 tions of use and any applicable subsequent de5 terminations thereunder), as so in effect; or 

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

7 order issued under this section. 

8 ‘‘(4) LIMITATIONS ON PRODUCT DIFFERENTIA9 TION.— 

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

11 period may be granted per ingredient under 

12 paragraph (1). 

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

14 differentiation under this subparagraph shall 

15 apply to changes to a sunscreen that are— 

16 ‘‘(i) ‘Tier 2’ changes described in sec17 tion 744L(14)(A); 

18 ‘‘(ii) safety-related changes described 

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

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

21 the Secretary determines necessary to en22 sure safe use; or 

23 ‘‘(iii) changes related to methods of 

24 testing safety or efficacy. 


sradovich on DSK3GMQ082PROD with BILLS
59 

•S 2315 RS

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

2 SUCCESSORS IN INTEREST.—Requestors shall submit 

3 to the Secretary at the time when a final dosage 

4 form subject to such request is introduced or deliv5 ered for introduction into interstate commerce, a list 

6 of licensees, assignees, or successors in interest that 

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

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

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

10 from clinical trials of safety or effectiveness (includ11 ing actual use studies), pharmacokinetics, or bio12 availability.’’. 

13 (d) SUNSCREEN INNOVATION ACT AMENDMENTS.— 

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

15 Act (21 U.S.C. 360fff–3(e)) is amended by striking para16 graph (3) and inserting the following: 

17 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SEC18 TION 505G.—A final sunscreen order shall be deemed 

19 to be a final administrative order under section 

20 505G and subject to the applicable provisions under 

21 such section 505G, including with respect to amend22 ment of such order.’’. 

23 (e) PRECLUSION OF NEW SUNSCREEN SUBMISSIONS; 

24 OPTION TO TRANSFER SUBMISSIONS TO OTC MONO25 GRAPH ORDER PROCESS.— 


sradovich on DSK3GMQ082PROD with BILLS
60 

•S 2315 RS

1 (1) SUNSET.—Beginning on the date of enact2 ment of this Act, section 586A of the Federal Food, 

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

4 have no force or effect. 

5 (2) OPTION TO TRANSFER SUBMISSIONS TO OTC

6 MONOGRAPH ORDER PROCESS.— 

7 (A) IN GENERAL.—Any person who sub8 mitted a request described in subparagraph (B) 

9 may, at any time prior to the sunset of sub10 chapter I of chapter V of the Federal Food, 

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

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

13 such request from the process under such sub14 chapter and resubmit such request as an order 

15 request under section 505G of such Act. 

16 (B) REQUESTS.—A request described in 

17 this subparagraph is— 

18 (i) a request under section 586A of 

19 the Federal Food, Drug, and Cosmetic Act 

20 submitted before the date of enactment of 

21 this Act; or 

22 (ii) a pending request described in 

23 section 586(6). 

24 (f) TREATMENT OF AUTHORITY REGARDING FINAL25 IZATION OF SUNSCREEN MONOGRAPH.—Section 586E of 


sradovich on DSK3GMQ082PROD with BILLS
61 

•S 2315 RS

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

2 360fff–5) is amended to read as follows: 

3 ‘‘SEC. 586E. SUNSCREEN ORDER. 

4 ‘‘(a) IN GENERAL.— 

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

6 Not later than November 26, 2019, the Secretary 

7 shall amend and revise the final administrative order 

8 concerning nonprescription sunscreen (referred to in 

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

10 substance, prior to the date of enactment of the 

11 Over-the-Counter Drug Safety, Innovation, and Re12 form Act, was represented by stayed regulations 

13 under part 352 of title 21, Code of Federal Regula14 tions. 

15 ‘‘(2) ISSUANCE OF REVISED SUNSCREEN

16 ORDER; EFFECTIVE DATE.—A revised sunscreen 

17 order described in paragraph (1) shall be— 

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

19 2019; and 

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

21 calendar days prior to such date. 

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

23 under subsection (a) does not include provisions related 

24 to the effectiveness of various sun protection factor levels, 

25 and does not address all dosage forms known to the SecVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
62 

•S 2315 RS

1 retary to be used in sunscreens marketed in the United 

2 States without a new drug application approved under sec3 tion 505, the Secretary shall submit a report to the Com4 mittee on Health, Education, Labor, and Pensions of the 

5 Senate and the Committee on Energy and Commerce of 

6 the House of Representatives on the rationale for omission 

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

8 timeline to compile any information necessary to address 

9 such provisions through such order.’’. 

10 (g) SUNSET OF PROCESS UNDER SUNSCREEN INNO11 VATION ACT.—Subchapter I of chapter V of the Federal 

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

13 as amended by subsection (f), is further amended by in14 serting at the end the following new section: 

15 ‘‘SEC. 586H. SUNSET. 

16 ‘‘This subchapter shall no longer be effective upon 

17 the later of— 

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

19 under this subchapter with respect to every request 

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

21 withdrawn requests and requests resubmitted as 

22 order requests under section 505G); or 

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

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


sradovich on DSK3GMQ082PROD with BILLS
63 

•S 2315 RS

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

2 REVIEW. 

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

4 amendments made by this Act) shall apply to any non5 prescription drug which was excluded by the Food and 

6 Drug Administration from the Over-the-Counter Drug Re7 view in accordance with the statement set out at page 

8 9466 of volume 37 of the Federal Register, published on 

9 May 11, 1972. 

10 (b) RULE OF CONSTRUCTION.—Nothing in this sec11 tion shall be construed to preclude or limit the applica12 bility of any provision of the Federal Food, Drug, and 

13 Cosmetic Act. 

14 SEC. 105. CONFORMING AMENDMENT. 

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

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

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

18 (A) by striking ‘‘final regulation’’ and in19 serting ‘‘final order’’; and 

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

21 (2) in subparagraph (A), by striking ‘‘regula22 tion in effect’’ and inserting ‘‘regulation or order in 

23 effect’’. 


sradovich on DSK3GMQ082PROD with BILLS
64 

•S 2315 RS

1 SEC. 106. ANNUAL UPDATE TO CONGRESS ON APPRO2 PRIATE PEDIATRIC INDICATION FOR CER3 TAIN COUGH AND COLD MONOGRAPH DRUGS. 

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

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

6 Secretary of Health and Human Services (referred to in 

7 this section as the ‘‘Secretary’’) shall submit to the Com8 mittee on Health, Education, Labor, and Pensions of the 

9 Senate and the Committee on Energy and Commerce of 

10 the House of Representatives a letter describing the 

11 progress of the Food and Drug Administration— 

12 (1) in evaluating the cough and cold monograph 

13 described in subsection (b) with respect to children 

14 under age 6; and 

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

16 monograph to address such children, through the ad17 ministrative order process under section 505G(b) of 

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

19 added by section 101. 

20 (b) COUGH AND COLD MONOGRAPH DESCRIBED.— 

21 The cough and cold monograph described in this sub22 section consists of the conditions under which nonprescrip23 tion drug products containing antitussive, expectorant, 

24 nasal decongestant, or antihistamine active ingredients (or 

25 combinations thereof) are generally recognized as safe and 

26 effective, as specified in part 341 of title 21, Code of FedVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
65 

•S 2315 RS

1 eral Regulations (as in effect on the day before the date 

2 of enactment of this Act), and included in an administra3 tive order deemed established under such section 505G(b) 

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

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

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

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

8 which the Secretary indicates that the Food and Drug Ad9 ministration has completed its evaluation and revised, in 

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

11 cold monograph in accordance with this section. 

12 TITLE II—FEES RELATING TO 

13 MONOGRAPH DRUGS 

14 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

17 (b) FINDINGS.—The Congress finds that the fees au18 thorized by the amendments made in this title will be dedi19 cated toward the regulation of monograph drugs under 

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

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

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

23 and Human Services to the Chairman of the Committee 

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

25 and the Chairman of the Committee on Energy and ComVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00065 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
66 

•S 2315 RS

1 merce of the House of Representatives, as set forth in the 

2 Congressional Record. 

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

4 Subchapter C of chapter VII of the Federal Food, 

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

6 amended by adding at the end the following: 

7 ‘‘PART 10—FEES RELATING TO MONOGRAPH 

8 DRUGS 

9 ‘‘SEC. 744L. DEFINITIONS. 

10 ‘‘For purposes of this part: 

11 ‘‘(1) The term ‘affiliate’ means a business enti12 ty that has a relationship with a second business en13 tity if, directly or indirectly— 

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

15 the power to control, the other business entity; 

16 or 

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

18 to control, both of the business entities. 

19 ‘‘(2) the term ‘contract manufacturing organi20 zation facility’ means a monograph drug facility 

21 where neither the owner of such manufacturing fa22 cility nor any affiliate of such owner or facility sells 

23 such monograph drug produced at such facility di24 rectly to wholesalers, retailers, or consumers in the 

25 United States. 


sradovich on DSK3GMQ082PROD with BILLS
67 

•S 2315 RS

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

2 monograph drug activities’ means the expenses in 

3 connection with monograph drug activities for— 

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

5 and Drug Administration, contractors of the 

6 Food and Drug Administration, advisory com7 mittees, and costs related to such officers, em8 ployees, and committees and to contracts with 

9 such contractors; 

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

11 acquisition, maintenance, and repair of com12 puter resources; 

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

14 repair of facilities and acquisition, maintenance, 

15 and repair of fixtures, furniture, scientific 

16 equipment, and other necessary materials and 

17 supplies; and 

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

19 and accounting for resources allocated for 

20 monograph drug activities. 

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

22 the unique number automatically generated by the 

23 Field Accomplishments and Compliance Tracking 

24 System of the Food and Drug Administration. 


sradovich on DSK3GMQ082PROD with BILLS
68 

•S 2315 RS

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

2 meaning given the term under section 505G. 

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

4 means activities of the Secretary associated with 

5 monograph drug products and inspection of facilities 

6 associated with such products, including— 

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

8 evaluation of monograph drugs and monograph 

9 drug order requests, including— 

10 ‘‘(i) orders proposing or finalizing ap11 plicable requirements of use for monograph 

12 drugs products; 

13 ‘‘(ii) orders affecting status regarding 

14 general recognition of safety and effective15 ness of a monograph drug ingredient or 

16 combination of ingredients under specified 

17 requirements of use; 

18 ‘‘(iii) all monograph drug development 

19 and review activities, including intra-agen20 cy collaboration; 

21 ‘‘(iv) regulation and policy develop22 ment activities related to monograph 

23 drugs; 


sradovich on DSK3GMQ082PROD with BILLS
69 

•S 2315 RS

1 ‘‘(v) development of product standards 

2 for products subject to review and evalua3 tion; 

4 ‘‘(vi) meetings regarding monograph 

5 drug activities; 

6 ‘‘(vii) review of labeling prior to 

7 issuance of orders related to monograph 

8 drugs or conditions of use; and 

9 ‘‘(viii) regulatory science activities re10 lated to monograph drugs; 

11 ‘‘(B) inspections related to monograph 

12 drugs; 

13 ‘‘(C) monitoring of clinical and other re14 search conducted in connection with monograph 

15 drugs; 

16 ‘‘(D) safety activities with respect to mono17 graph drugs, including— 

18 ‘‘(i) collecting, developing, and review19 ing safety information on monograph 

20 drugs, including adverse event reports; 

21 ‘‘(ii) developing and using improved 

22 adverse event data-collection systems, in23 cluding information technology systems; 

24 and 


sradovich on DSK3GMQ082PROD with BILLS
70 

•S 2315 RS

1 ‘‘(iii) developing and using improved 

2 analytical tools to assess potential safety 

3 risks, including access to external data4 bases; and 

5 ‘‘(E) other activities necessary for imple6 mentation of section 505G. 

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

8 means a foreign or domestic business or other enti9 ty— 

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

11 direct or indirect; 

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

13 engaged in manufacturing or processing a 

14 monograph drug in finished dosage form; 

15 ‘‘(iii) includes a finished dosage form man16 ufacturer facility or an affiliate thereof in a 

17 contractual relationship with a monograph drug 

18 requestor or requestors to manufacture or proc19 ess monograph drugs; and 

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

21 entity whose only manufacturing or processing 

22 activities relate to— 

23 ‘‘(I) production of clinical research 

24 supplies; 

25 ‘‘(II) testing; or 


sradovich on DSK3GMQ082PROD with BILLS
71 

•S 2315 RS

1 ‘‘(III) packaging of packaged final 

2 dosages in a manner that does not affect 

3 the drug. 

4 ‘‘(B) For purposes of subparagraph (A), sepa5 rate buildings or locations within close proximity are 

6 considered to be at 1 geographic location or address 

7 if the activities conducted in them are— 

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

9 enterprise; 

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

11 local management; and 

12 ‘‘(iii) under a single firm establishment 

13 identifier and capable of being inspected by the 

14 Food and Drug Administration during a single 

15 inspection. 

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

17 the definition of a facility under this paragraph but 

18 for being under multiple management, the business 

19 or other entity is deemed to constitute multiple fa20 cilities, one per management entity, for purposes of 

21 this paragraph. 

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

23 means any meeting regarding the content of a pro24 posed monograph drug order request. 


sradovich on DSK3GMQ082PROD with BILLS
72 

•S 2315 RS

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

2 means a monograph drug product that is marketed 

3 without an approved new drug application in accord4 ance with section 505G. 

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

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

7 the issuance of an administrative order for a change 

8 to the monograph drug product. 

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

10 means an entity submitting a monograph drug order 

11 request or a monograph drug meeting request or any 

12 other inquiry relating to a request for an order or 

13 development of a monograph drug order request. 

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

15 thereof. 

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

17 request’ means any monograph drug order request 

18 not determined to be a Tier 2 monograph drug order 

19 request. 

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

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

22 monograph drug order request for— 

23 ‘‘(i) the reordering of existing information 

24 in the drug facts label of a monograph drug 

25 product; 


sradovich on DSK3GMQ082PROD with BILLS
73 

•S 2315 RS

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

2 other information section of the drug facts label 

3 of a nonprescription drug product, as limited by 

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

5 Regulations; 

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

7 section of the drug facts label of a nonprescrip8 tion drug product, if such changes conform to 

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

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

12 within a particular finalized monograph; 

13 ‘‘(v) a change to ingredient nomenclature 

14 to align with nomenclature of a standards-set15 ting organization; or 

16 ‘‘(vi) addition of an interchangeable term 

17 in accordance with part 330.1 of title 21, Code 

18 of Federal Regulations. 

19 ‘‘(B) The Secretary may, based on program im20 plementation experience or other factors found ap21 propriate by the Secretary, characterize any mono22 graph drug order request as a Tier 2 monograph 

23 drug order request (including recategorizing a re24 quest from Tier 1 to Tier 2) and publish such deterVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00073 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
74 

•S 2315 RS

1 mination in a proposed order issued pursuant to sec2 tion 505G(c). 

3 ‘‘SEC. 744L–1. AUTHORITY TO ASSESS AND USE MONO4 GRAPH DRUG FEES. 

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

6 2018, the Secretary shall assess and collect fees in accord7 ance with this section as follows: 

8 ‘‘(1) FACILITY FEE.— 

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

10 subparagraph (B), each person that owns a fa11 cility identified as a monograph drug facility on 

12 December 31 of the fiscal year or at any time 

13 during the preceding 12-month period shall be 

14 assessed an annual fee for each such facility as 

15 determined under subsection (c). 

16 ‘‘(B) EXCEPTION.— 

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

18 assessed under subparagraph (A) if the 

19 identified monograph drug facility has 

20 ceased all activities related to monograph 

21 drug products prior to the publication of 

22 the Notice under subparagraph C and has 

23 updated its registration to reflect such 

24 change under the requirements for drug 


sradovich on DSK3GMQ082PROD with BILLS
75 

•S 2315 RS

1 establishment registration set forth in sec2 tion 510. 

3 ‘‘(ii) FEE AMOUNT.—The amount of 

4 the fee for a contract manufacturing orga5 nization facility shall be equal to two-thirds 

6 the amount of the fee for a monograph 

7 drug facility that is not a contract manu8 facturing organization facility. 

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

10 facility fees required under subparagraph (A) 

11 shall be due on the later of— 

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

13 such year; and 

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

15 date of enactment of an appropriations Act 

16 providing for the collection and obligation 

17 of fees under this section for such year. 

18 ‘‘(2) MONOGRAPH DRUG ORDER REQUEST

19 FEE.— 

20 ‘‘(A) IN GENERAL.—Each person that sub21 mits a monograph drug order request shall be 

22 subject to a fee for a monograph drug order re23 quest. The monograph drug order request fee 

24 under paragraph (2) shall be— 


sradovich on DSK3GMQ082PROD with BILLS
76 

•S 2315 RS

1 ‘‘(i) for a Tier 1 monograph drug 

2 order request, $500,000, adjusted for in3 flation for the fiscal year (as determined 

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

5 ‘‘(ii) for a Tier 2 monograph drug 

6 order request other than a Tier 1 request, 

7 $100,000 adjusted for inflation for the fis8 cal year (as determined under subsection 

9 (c)(1)). 

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

11 order request fees required under subparagraph 

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

13 the monograph drug order request. 

14 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

15 CHANGES.—A person who is named as the re16 questor in a monograph drug order shall not be 

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

18 Secretary finds that the monograph drug order 

19 request seeks to change the Drug Facts labeling 

20 of a monograph drug product in a way that 

21 would add to or strengthen— 

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

23 precaution; 

24 ‘‘(ii) a statement about risk associated 

25 with misuse or abuse; or 


sradovich on DSK3GMQ082PROD with BILLS
77 

•S 2315 RS

1 ‘‘(iii) an instruction about dosage and 

2 administration that is intended to increase 

3 the safe use of the monograph drug prod4 uct. 

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

6 IS RECATEGORIZED AS A TIER 2 MONOGRAPH

7 DRUG ORDER REQUEST.—If the Secretary de8 termines that a monograph drug request ini9 tially characterized as Tier 1 should be re-char10 acterized as a Tier 2 monograph drug order re11 quest, and the requestor has paid a Tier 1 fee 

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

13 Secretary shall refund the requestor the dif14 ference between the Tier 1 and Tier 2 fees de15 termined under subparagraphs (A)(i) and 

16 (A)(ii), respectively. 

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

18 REFUSED FOR FILING OR WITHDRAWN BEFORE

19 FILING.—The Secretary shall refund 75 percent 

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

21 order request that is refused for filing. 

22 ‘‘(F) FEES FOR ORDER REQUESTS PRE23 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

24 BEFORE FILING.—A monograph drug order re25 quest that was submitted but was refused for 


sradovich on DSK3GMQ082PROD with BILLS
78 

•S 2315 RS

1 filing, or was withdrawn before being accepted 

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

3 fee under subparagraph (A) upon being resub4 mitted or filed over protest. 

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

6 WITHDRAWN.—If an order request is withdrawn 

7 after the order request was filed, the Secretary 

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

9 substantial work was performed on the order 

10 request after the application was filed. The Sec11 retary shall have the sole discretion to refund a 

12 fee or a portion of the fee under this subpara13 graph. A determination by the Secretary con14 cerning a refund under this paragraph shall not 

15 be reviewable. 

16 ‘‘(3) REFUNDS.— 

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

18 under subparagraphs (D) through (G) of para19 graph (2), the Secretary shall not refund any 

20 fee paid under this subsection, except as pro21 vided in subparagraph (B). 

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

23 qualify for the return of a fee claimed to have 

24 been paid in error under this paragraph, a per25 son shall submit to the Secretary a written reVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00078 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
79 

•S 2315 RS

1 quest justifying such return within 180 cal2 endar days after such fee was paid. 

3 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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

6 generate a total facility fee revenue amount equal to 

7 the sum of— 

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

9 year 2018 (as determined under paragraph 

10 (3)); 

11 ‘‘(B) the dollar amount equal to the oper12 ating reserve adjustment for the fiscal year, if 

13 applicable (as determined under subsection 

14 (c)(2)); and 

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

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

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

18 the fiscal years 2019 through 2022, fees under sub19 section (a)(1) shall be established to generate a total 

20 facility fee revenue amount equal to the sum of— 

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

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

23 ‘‘(B) the dollar amount equal to the infla24 tion adjustment for the fiscal year (as deter25 mined under subsection (c)(1)); 


sradovich on DSK3GMQ082PROD with BILLS
80 

•S 2315 RS

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

3 applicable (as determined under subsection 

4 (c)(2)); 

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

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

7 ‘‘(E) additional dollar amounts for each 

8 fiscal year as follows: 

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

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

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

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

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

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

15 of the annual base revenue for a fiscal year shall 

16 be— 

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

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

19 the dollar amount of the total revenue amount 

20 established under this subsection for the pre21 vious fiscal year, not including any adjustments 

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

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

24 ‘‘(1) INFLATION ADJUSTMENT.— 


sradovich on DSK3GMQ082PROD with BILLS
81 

•S 2315 RS

1 ‘‘(A) IN GENERAL.—For purposes of sub2 section (b)(2)(B), the dollar amount of the in3 flation adjustment to the annual base revenue 

4 for fiscal year 2019 and each subsequent fiscal 

5 year shall be equal to the product of— 

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

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

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

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

12 under this subparagraph for a fiscal year is 

13 equal to— 

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

15 through 2020, the average annual percent 

16 change that occurred in the Consumer 

17 Price Index for urban consumers (Wash18 ington-Baltimore, DC–MD–VA–WV; Not 

19 Seasonally Adjusted; All items; Annual 

20 Index) for the first 3 years of the pre21 ceding 4 years of available data; and 

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

23 2022, the sum of— 

24 ‘‘(I) the average annual percent 

25 change in the cost, per full-time equivVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
82 

•S 2315 RS

1 alent position of the Food and Drug 

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

5 years of the preceding 4 fiscal years, 

6 multiplied by the proportion of per7 sonnel compensation and benefits 

8 costs to total costs of monograph drug 

9 activities (as defined in subsection 

10 (a)) for the first 3 years of the pre11 ceding 4 fiscal years; and 

12 ‘‘(II) the average annual percent 

13 change that occurred in the Consumer 

14 Price Index for urban consumers 

15 (Washington-Baltimore, DC–MD–VA– 

16 WV; Not Seasonally Adjusted; All 

17 items; Annual Index) for the first 3 

18 years of the preceding 4 years of 

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

22 costs to total costs of monograph drug 

23 activities for the first 3 years of the 

24 preceding 4 fiscal years. 

25 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 


sradovich on DSK3GMQ082PROD with BILLS
83 

•S 2315 RS

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

2 fiscal years, the Secretary may, in addition to 

3 adjustments under paragraphs (1) and (2), fur4 ther increase the fee revenue and fees if such 

5 an adjustment is necessary to provide operating 

6 reserves of carryover user fees for monograph 

7 drug activities for the number of weeks speci8 fied in subparagraph (B). 

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

10 weeks of operating reserves shall be no more 

11 than— 

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

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

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

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

16 and 

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

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

19 2022, the Secretary has carryover balances for 

20 monograph drug activities in excess of the num21 ber of weeks of such operating reserves speci22 fied in subparagraph B, the Secretary shall re23 duce such fee revenue and fees to provide for 

24 not more than the number of weeks of such opVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
84 

•S 2315 RS

1 erating reserves specified in subparagraph 

2 (B)(v). 

3 ‘‘(D) If an adjustment under this para4 graph is made, the rationale for the amount of 

5 the increase or decrease (as applicable) in fee 

6 revenue and fees shall be contained in the an7 nual Federal Register notice under paragraph 

8 (5) establishing fee revenue and fees for the fis9 cal year involved. 

10 ‘‘(3) ADDITIONAL DIRECT COST ADJUST11 MENT.—The Secretary shall, in addition to adjust12 ments under paragraphs (1) and (2), further in13 crease the fee revenue by an amount equal to— 

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

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

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

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

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

19 ‘‘(4) ANNUAL FEE SETTING.— 

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

21 shall, not later than January 31, 2018— 

22 ‘‘(i) establish monograph drug facility 

23 fees for fiscal year 2018 under subsection 

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

25 such year under subsection (b) and the adVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00084 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
85 

•S 2315 RS

1 justments provided under this subsection; 

2 and 

3 ‘‘(ii) publish such fee revenue and fa4 cility fees in the Federal Register. 

5 ‘‘(B) SUBSEQUENT FISCAL YEARS.—The 

6 Secretary shall, not later than January 31 of 

7 each fiscal year that begins after September 30, 

8 2018, establish for each such fiscal year, based 

9 on the revenue amounts under subsection (b) 

10 and the adjustments provided under this sub11 section— 

12 ‘‘(i) monograph drug facility fees 

13 under subsection (a)(1); 

14 ‘‘(ii) monograph drug order request 

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

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

17 fees, and monograph drug order request 

18 fees in the Federal Register. 

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

20 that owns a monograph drug facility shall submit to the 

21 Secretary the information required under this subsection 

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

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

24 for drug establishment registration set forth in sec25 tion 510; and 


sradovich on DSK3GMQ082PROD with BILLS
86 

•S 2315 RS

1 ‘‘(2) include for each such facility, at a min2 imum, identification of the facility’s business oper3 ation as that of a monograph drug facility. 

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

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

6 request submitted by a person subject to fees under 

7 subsection (a) shall be considered incomplete and 

8 shall not be accepted for filing by the Secretary until 

9 all fees owed by such person have been paid. 

10 ‘‘(2) EFFECT ON ELIGIBILITY FOR MEET11 INGS.—If a monograph drug requestor fails to pay 

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

13 shall be considered ineligible for monograph drug 

14 meetings. 

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

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

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

18 such subsection shall result in the Secretary placing the 

19 facility on a publicly available arrears list until such fee 

20 has been paid. 

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

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

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

24 collected and available for obligation only to the ex25 tent and in the amount provided in advance in apVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00086 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
87 

•S 2315 RS

1 propriations Acts. Such fees are authorized to re2 main available until expended. Such sums as may be 

3 necessary may be transferred from the Food and 

4 Drug Administration salaries and expenses appro5 priation account without fiscal year limitation to 

6 such appropriation account for salaries and expenses 

7 with such fiscal year limitation. The sums trans8 ferred shall be available solely for monograph drug 

9 activities. 

10 ‘‘(2) COLLECTIONS AND APPROPRIATION

11 ACTS.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graphs (C) and (D), the fees authorized by this 

14 section shall be collected and available in each 

15 fiscal year in an amount not to exceed the 

16 amount specified in appropriation Acts, or oth17 erwise made available for obligation, for such 

18 fiscal year. 

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

20 The fees authorized by this section shall be 

21 available to defray increases in the costs of the 

22 resources allocated for monograph drug activi23 ties (including increases in such costs for an ad24 ditional number of full-time equivalent positions 

25 in the Department of Health and Human ServVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00087 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
88 

•S 2315 RS

1 ices to be engaged in such activities), only if the 

2 Secretary allocates for such purpose an amount 

3 for such fiscal year (excluding amounts from 

4 fees collecting under this section) no less than 

5 $12,000,000, multiplied by the adjustment fac6 tor applicable to the fiscal year involved. 

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

8 be considered to have met the requirements of 

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

10 funded by appropriations and allocated for the 

11 monograph drug activities are not more than 15 

12 percent below the level specified in such sub13 paragraph. 

14 ‘‘(D) FEE COLLECTION DURING FIRST

15 PROGRAM YEAR.—Until the date of enactment 

16 of an Act making appropriations and providing 

17 for the collection and obligation of fees under 

18 this section through September 30, 2018, for 

19 the salaries and expenses account of the Food 

20 and Drug Administration, fees authorized by 

21 this section for fiscal year 2018 may be col22 lected and shall be credited to such account and 

23 remain available until expended. 

24 ‘‘(E) PROVISION FOR EARLY PAYMENTS IN

25 SUBSEQUENT YEARS.—Payment of fees authorVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00088 Fmt 6652 Sfmt 6401 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
89 

•S 2315 RS

1 ized under this section for a fiscal year (after 

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

3 fees, may be accepted by the Secretary in ac4 cordance with authority provided in advance in 

5 a prior year appropriations Act. 

6 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

7 For each of the fiscal years 2018 through 2022, 

8 there is authorized to be appropriated for fees under 

9 this section an amount equal to the total amount of 

10 fees assessed for such fiscal year under this section. 

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

12 where the Secretary does not receive payment of a fee as13 sessed under subsection (a) within 30 calendar days after 

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

15 States Government subject to subchapter II of chapter 37 

16 of title 31. 

17 ‘‘(i) CONSTRUCTION.—This section may not be con18 strued to require that the number of full-time equivalent 

19 positions in the Department of Health and Human Serv20 ices, for officers, employers, and advisory committees not 

21 engaged in monograph drug activities, be reduced to offset 

22 the number of officers, employees, and advisory commit23 tees so engaged. 


sradovich on DSK3GMQ082PROD with BILLS
90 

•S 2315 RS

1 ‘‘SEC. 744L–2. REAUTHORIZATION; REPORTING REQUIRE2 MENTS. 

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

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

5 end of each fiscal year thereafter for which fees are col6 lected under this part, the Secretary shall prepare and 

7 submit to the Committee on the Health, Education, 

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

9 Energy and Commerce of the House of Representatives 

10 a report concerning the progress of the Food and Drug 

11 Administration in achieving the goals identified in the let12 ters described in section 201 of the during such fiscal year 

13 and the future plans of the Food and Drug Administration 

14 for meeting such goals. 

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

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

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

18 the Secretary shall prepare and submit to the Committee 

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

20 and the Committee on Energy and Commerce of the 

21 House of Representatives a report on the implementation 

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

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

24 collected for such fiscal year. 

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

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


sradovich on DSK3GMQ082PROD with BILLS
91 

•S 2315 RS

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

2 and Drug Administration. 

3 ‘‘(d) REAUTHORIZATION.— 

4 ‘‘(1) CONSULTATION.—In developing rec5 ommendations to present to Congress with respect to 

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

7 meeting the goals, for monograph drug activities for 

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

9 the reauthorization of this part for such fiscal years, 

10 the Secretary shall consult with— 

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

12 Labor, and Pensions of the Senate; 

13 ‘‘(B) the Committee on Energy and Com14 merce of the House of Representatives; 

15 ‘‘(C) scientific and academic experts; 

16 ‘‘(D) health care professionals; 

17 ‘‘(E) representatives of patient and con18 sumer advocacy groups; and 

19 ‘‘(F) the regulated industry. 

20 ‘‘(2) PUBLIC REVIEW OF RECOMMENDA21 TIONS.—After negotiations with the regulated indus22 try, the Secretary shall— 

23 ‘‘(A) present the recommendations devel24 oped under paragraph (1) to the congressional 

25 committees specified in such paragraph; 


sradovich on DSK3GMQ082PROD with BILLS
92 

•S 2315 RS

1 ‘‘(B) publish such recommendations in the 

2 Federal Register; 

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

4 days for the public to provide written comments 

5 on such recommendations; 

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

7 may present its views on such recommenda8 tions; and 

9 ‘‘(E) after consideration of such public 

10 views and comments, revise such recommenda11 tions as necessary. 

12 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.— 

13 Not later than January 15, 2022, the Secretary 

14 shall transmit to Congress the revised recommenda15 tions under paragraph (2), a summary of the views 

16 and comments received under such paragraph, and 

17 any changes made to the recommendations in re18 sponse to such views and comments.’’. 

19 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

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

22 Act’’. 

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

24 this Act is as follows: 

Sec. 1. Short title; table of contents. 


sradovich on DSK3GMQ082PROD with BILLS
93 

•S 2315 RS

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 assess 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 ‘non14 prescription drug’ means a drug that is not subject 

15 to section 503(b)(1). 

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

17 person or group of persons marketing, manufacturing, 

18 processing, or developing a drug. 


sradovich on DSK3GMQ082PROD with BILLS
94 

•S 2315 RS

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

2 person or group of persons marketing, manufacturing, 

3 or processing a drug and who has a listing in effect 

4 under section 510(j) for such drug. 

5 ‘‘(b) TREATMENT OF MONOGRAPH DRUGS MARKETED

6 WITHOUT AN APPROVED APPLICATION.— 

7 ‘‘(1) IN GENERAL.—A nonprescription drug that 

8 is marketed without an approved application under 

9 section 505 shall be treated in accordance with this 

10 subsection beginning on the date of enactment of the 

11 Over-the-Counter Drug Safety, Innovation, and Re12 form Act: 

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

14 be generally recognized as safe and effective with15 in the meaning of section 201(p)(1) and not a 

16 new drug under section 201(p) if such drug is— 

17 ‘‘(i)(I)(aa) subject to a final mono18 graph issued under part 330 of title 21, 

19 Code of Federal Regulations, as of the date 

20 of enactment of the Over-the-Counter Drug 

21 Safety, Innovation, and Reform Act; 

22 ‘‘(bb) in conformity with the require23 ments for nonprescription use of such mono24 graph, the general requirements specified for 


sradovich on DSK3GMQ082PROD with BILLS
95 

•S 2315 RS

1 nonprescription drugs, and the requirements 

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

3 ‘‘(cc) except as permitted by an admin4 istrative order issued under subsection (c) 

5 or a minor change in the drug in con6 formity with subsection (d), is in a dosage 

7 form that, on day before the date of enact8 ment of the Over-the-Counter Drug Safety, 

9 Innovation, and Reform Act, has been used 

10 to a material extent and for a material 

11 time within the meaning of section 

12 201(p)(2); 

13 ‘‘(II)(aa) the subject of a tentative 

14 final monograph that is the most recently 

15 applicable proposal or determination issued 

16 under part 330 of title 21, Code of Federal 

17 Regulations, on the day before the date of 

18 enactment of the Over-the-Counter Drug 

19 Safety, Innovation, and Reform Act; 

20 ‘‘(bb) classified in category I for safety 

21 and effectiveness under such tentative final 

22 monograph; 

23 ‘‘(cc) in conformity with the require24 ments for nonprescription use of such ten25 tative final monograph, any subsequent deVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00095 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
96 

•S 2315 RS

1 termination by the Secretary, the general 

2 requirements for nonprescription drugs, and 

3 the requirements under subsections (c), (d), 

4 and (j); and 

5 ‘‘(dd) except as permitted by an ad6 ministrative order issued under subsection 

7 (c) or a minor change in the drug in con8 formity with subsection (d), is in a dosage 

9 form that has been used to a material extent 

10 and for a material time within the meaning 

11 of section 201(p)(2); or 

12 ‘‘(III) in conformity with— 

13 ‘‘(aa) the requirements of a final 

14 administrative order issued under sub15 section (c) determining that such drug 

16 is generally recognized as safe and ef17 fective within the meaning of section 

18 201(p)(1); and 

19 ‘‘(bb) the general requirements for 

20 nonprescription drugs and the require21 ments under subsections (c), (d), and 

22 (j); 

23 ‘‘(ii) not classified in Category II for 

24 safety or effectiveness under a tentative 

25 final monograph; and 


sradovich on DSK3GMQ082PROD with BILLS
97 

•S 2315 RS

1 ‘‘(iii) not determined by the Secretary 

2 to be not generally recognized as safe and 

3 effective, in a final monograph or preamble 

4 to a rule that is the most recently applicable 

5 proposal or determination issued under 

6 part 330 of title 21, Code of Federal Regu7 lations. 

8 ‘‘(B) A nonprescription drug for which 

9 there is not an approved application under sec10 tion 505 may be introduced into interstate com11 merce if such drug is— 

12 ‘‘(i)(I) not classified in Category II for 

13 safety or effectiveness under a tentative 

14 final monograph; or 

15 ‘‘(II) not determined by the Secretary 

16 to be not generally recognized as safe and 

17 effective, in a final monograph or preamble 

18 to a rule that is the most recently applicable 

19 proposal or determination issued under 

20 part 330 of title 21, Code of Federal Regu21 lations; and 

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

23 final monograph that is the most recently 

24 applicable proposal or determination issued 


sradovich on DSK3GMQ082PROD with BILLS
98 

•S 2315 RS

1 under part 330 of title 21, Code of Federal 

2 Regulations; 

3 ‘‘(bb) classified in category III for safe4 ty or effectiveness in the preamble of a pro5 posed rule establishing such tentative final 

6 monograph; 

7 ‘‘(cc) in conformity with the most re8 cently proposed or final rule establishing or 

9 proposing conditions of nonprescription use 

10 published in the Federal Register related to 

11 such tentative final monograph, the general 

12 requirements for nonprescription drugs, and 

13 the requirements under subsections (c) and 

14 (j); and 

15 ‘‘(dd) in a dosage form that, as of the 

16 day before the date of enactment of the 

17 Over-the-Counter Drug Safety, Innovation, 

18 and Reform Act, has been used to a mate19 rial extent and for a material time within 

20 the meaning of section 201(p)(2); or 

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

22 monograph or advance notice of proposed 

23 rulemaking that is the most recently appli24 cable proposal or determination issued 


sradovich on DSK3GMQ082PROD with BILLS
99 

•S 2315 RS

1 under part 330 of title 21, Code of Federal 

2 Regulations; 

3 ‘‘(bb) classified in category I for safety 

4 and effectiveness under such proposed mono5 graph or advance notice of proposed rule6 making; 

7 ‘‘(cc) in conformity with the most re8 cently proposed or final rule establishing or 

9 proposing conditions of nonprescription use 

10 published in the Federal Register related to 

11 such proposed monograph or advance notice 

12 of proposed rulemaking, the general require13 ments for nonprescription drugs, and the 

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

15 and 

16 ‘‘(dd) in a dosage form that, as of the 

17 day before the date of enactment of the 

18 Over-the-Counter Drug Safety, Innovation, 

19 and Reform Act has been used to a material 

20 extent and for a material time within the 

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

22 ‘‘(C)(i) Subject to clause (iii), beginning on 

23 the date that is 180 calendar days after the date 

24 of enactment of the Over-the-Counter Drug Safe25 ty, Innovation, and Reform Act, a nonprescripVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00099 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
100 

•S 2315 RS

1 tion drug is deemed to be not generally recog2 nized as safe and effective within the meaning of 

3 section 201(p)(1), a new drug under section 

4 201(p), and misbranded under section 502(ee), if 

5 such drug— 

6 ‘‘(I) is classified in category II for 

7 safety or effectiveness under a tentative 

8 final monograph; or 

9 ‘‘(II) is subject to a determination to 

10 be not generally recognized as safe and effec11 tive under a proposed rule that is the most 

12 recently applicable proposal issued under 

13 part 330 of title 21, Code of Federal Regu14 lations. 

15 ‘‘(ii) A nonprescription drug that the Sec16 retary has determined to be not generally recog17 nized as safe and effective under a final deter18 mination issued under part 330 of title 21, Code 

19 of Federal Regulations is deemed to be not gen20 erally recognized as safe and effective within the 

21 meaning of section 201(p)(1), a new drug under 

22 section 201(p), and misbranded under section 

23 502(ee). 

24 ‘‘(iii) A 180-day period described in clause 

25 (i) may be extended with respect to a drug by the 


sradovich on DSK3GMQ082PROD with BILLS
101 

•S 2315 RS

1 Secretary if the Secretary determines that such 

2 extension is in the interest of the public health. 

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

4 monograph for sunscreen drug products set forth 

5 at part 352 of title 21, Code of Federal Regula6 tions (as published at volume 64 page 27687 of 

7 the Federal Register), shall comply with the re8 quirements of that monograph, except that the 

9 testing requirements for effectiveness and the pro10 visions governing labeling shall be in accordance 

11 with section 201.327 of title 21, Code of Federal 

12 Regulations (as in effect on the date of enact13 ment of the Over-the-Counter Drug Safety, Inno14 vation, and Reform Act), or such changes to 

15 those requirements as may be made under sub16 sections (c), (d), and (j). 

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

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

19 subject to the requirements of section 505 if the drug 

20 is— 

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

22 (B), (C), or (D) of paragraph (1) and not in 

23 conformity with subsection (d), as applicable; or 

24 ‘‘(B) not a nonprescription sunscreen active 

25 ingredient or combination of ingredients subject 


sradovich on DSK3GMQ082PROD with BILLS
102 

•S 2315 RS

1 to a final sunscreen order, as defined in section 

2 586(2). 

3 ‘‘(3) MONOGRAPH DRUG.—In this section, the 

4 term ‘monograph drug’ has the meaning given such 

5 term in section 744L. 

6 ‘‘(4) RULES OF CONSTRUCTION.— 

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

8 affect the treatment or status of a nonprescrip9 tion drug subject to section 505— 

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

11 the Over-the-Counter Drug Safety, Innova12 tion, and Reform Act, is marketed without 

13 an application approved under section 505; 

14 and 

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

16 (C), and (D) of paragraph (1) do not apply. 

17 ‘‘(B) APPLICABILITY OF OTHER PROVI18 SIONS.—Nothing in this paragraph shall be con19 strued to preclude or limit the applicability of 

20 any other provision of this Act. 

21 ‘‘(C) NO EFFECT ON OTHER AUTHORI22 TIES.—Nothing in this subsection shall be con23 strued to prohibit the Secretary from issuing an 

24 order under this section finding a drug to be not 

25 generally recognized as safe and effective. 


sradovich on DSK3GMQ082PROD with BILLS
103 

•S 2315 RS

1 ‘‘(c) ADMINISTRATIVE ORDERS.— 

2 ‘‘(1) IN GENERAL.— 

3 ‘‘(A) GENERALLY RECOGNIZED AS SAFE

4 AND EFFECTIVE.—The Secretary may, on the 

5 initiative of the Secretary or at the request of 

6 one or more requestors, issue an administrative 

7 order determining whether there are require8 ments under which a specific drug, class of such 

9 drugs, or combination of such drugs is deter10 mined to be— 

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

12 ‘‘(ii) generally recognized as safe and 

13 effective within the meaning of section 

14 201(p)(1); and 

15 ‘‘(iii) not required to be approved 

16 under section 505. 

17 ‘‘(B) NOT GENERALLY RECOGNIZED AS SAFE

18 AND EFFECTIVE.—The Secretary shall issue an 

19 order determining that a drug is not generally 

20 recognized as safe and effective within the mean21 ing of section 201(p)(1) for the specified require22 ments if the Secretary determines that— 

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

24 not generally recognized as safe and effective 

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


sradovich on DSK3GMQ082PROD with BILLS
104 

•S 2315 RS

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

2 that the drug is generally recognized as safe 

3 and effective within the meaning of section 

4 201(p)(1). 

5 ‘‘(2) ADMINISTRATIVE ORDERS INITIATED BY

6 THE SECRETARY; CITIZEN PETITIONS.— 

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

8 paragraph (5), in issuing an administrative 

9 order under paragraph (1) on the initiative of 

10 the Secretary, the Secretary shall— 

11 ‘‘(i) not later than 2 business days be12 fore issuance of the proposed order, infor13 mally communicate the pending issuance of 

14 the order to sponsors of drugs that have a 

15 listing in effect under section 510(j) for 

16 drugs will be subject to such order; 

17 ‘‘(ii) after making any such informal 

18 communication— 

19 ‘‘(I) issue such a proposed admin20 istrative order by publishing it on the 

21 internet website of the Food and Drug 

22 Administration and include in such 

23 order the reasons for the issuance of 

24 such order; and 


sradovich on DSK3GMQ082PROD with BILLS
105 

•S 2315 RS

1 ‘‘(II) publish notice of availability 

2 of such proposed order in the Federal 

3 Register; 

4 ‘‘(iii) except as provided in subpara5 graph (B), provide for a public comment 

6 period with respect to such proposed order 

7 of not less than 45 calendar days; and 

8 ‘‘(iv) if, after satisfying the require9 ments of clauses (i) through (iii), the Sec10 retary determines that it is appropriate to 

11 issue a final administrative order— 

12 ‘‘(I) issue the final administrative 

13 order, together with a detailed state14 ment of reasons, but such order shall 

15 not take effect until the time for re16 questing judicial review under para17 graph (4)(D)(ii) has expired; 

18 ‘‘(II) publish a notice of avail19 ability of such final administrative 

20 order in the Federal Register; 

21 ‘‘(III) afford requestors of prod22 ucts that will be subject to such order 

23 the opportunity for formal dispute res24 olution up to the level of the Director 

25 of the Center for Drug Evaluation and 


sradovich on DSK3GMQ082PROD with BILLS
106 

•S 2315 RS

1 Research, which initially shall be re2 quested within 45 calendar days of the 

3 issuance of the order, and, for subse4 quent levels of appeal, within 30 cal5 endar days of the prior decision; and 

6 ‘‘(IV) except with respect to drugs 

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

8 completion of the formal dispute reso9 lution procedure, inform the person or 

10 persons which sought such dispute reso11 lution of their right to request a hear12 ing. 

13 ‘‘(B) SPECIAL REQUIREMENTS WITH RE14 SPECT TO CERTAIN MONOGRAPH DRUGS.—When 

15 issuing an administrative order under para16 graph (1) on the initiative of the Secretary (ex17 cept as provided under paragraph (4)) proposing 

18 to determine that a monograph drug described in 

19 subsection (b)(1)(B) is not generally recognized 

20 as safe and effective within the meaning of sec21 tion 201(p)(1), the Secretary shall follow the pro22 cedures in subparagraph (A) except that— 

23 ‘‘(i) the proposed order shall include 

24 notice of— 


sradovich on DSK3GMQ082PROD with BILLS
107 

•S 2315 RS

1 ‘‘(I) the general categories of data 

2 the Secretary has determined necessary 

3 to establish that the drug is generally 

4 recognized as safe and effective within 

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

6 ‘‘(II) the format for submissions 

7 by interested persons; 

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

9 public comment period of not less than 180 

10 calendar days with respect to such proposed 

11 order, except when the Secretary determines, 

12 for good cause, that a shorter period is in 

13 the interest of public health; and 

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

15 such comment period shall include a certifi16 cation that the person has submitted all evi17 dence created, obtained, or received by that 

18 person that is both within the categories of 

19 data identified in the proposed order and 

20 relevant to a determination as to whether 

21 the drug is generally recognized as safe and 

22 effective within the meaning of section 

23 201(p)(1). 

24 ‘‘(C) CITIZEN PETITIONS.— 


sradovich on DSK3GMQ082PROD with BILLS
108 

•S 2315 RS

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

2 issue an administrative order under para3 graph (1) in response to a citizen petition 

4 submitted under section 10.30 of title 21, 

5 Code of Federal Regulations (or any suc6 cessor regulation), subject to clause (ii). 

7 ‘‘(ii) EFFECT OF PETITION.—Nothing 

8 in clause (i) shall be construed to provide 

9 an alternative to, or otherwise supplant or 

10 supersede— 

11 ‘‘(I) the processes through which a 

12 requestor may seek an administrative 

13 order pursuant to paragraph (5); or 

14 ‘‘(II) the fee structure under sec15 tion 744L–1(a)(2). 

16 ‘‘(3) HEARINGS; JUDICIAL REVIEW.— 

17 ‘‘(A) IN GENERAL.—A person who partici18 pated in each level of formal dispute resolution 

19 under paragraph (2)(A)(iv)(III) of an adminis20 trative order with respect to a drug may request 

21 a hearing concerning a final administrative 

22 order issued under paragraph (2)(A)(iv) with re23 spect to such drug. Such person may submit a 

24 request for a hearing, which shall be based solely 

25 on the information in the administrative record, 


sradovich on DSK3GMQ082PROD with BILLS
109 

•S 2315 RS

1 to the Secretary not later than 30 calendar days 

2 after receiving notice of the final decision of the 

3 formal dispute resolution procedure. 

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

6 DRUGS.—The Secretary is not required to pro7 vide notice and an opportunity for a hearing 

8 pursuant to paragraph (2)(A)(iv) if the final ad9 ministrative order involved relates to a drug— 

10 ‘‘(i) that is described in subsection 

11 (b)(1)(B)(ii)(I); and 

12 ‘‘(ii) with respect to which no data rel13 evant to the safety or effectiveness of such 

14 drug have been submitted to the administra15 tive record since the issuance of the most re16 cent tentative final monograph relating to 

17 such drug (or, as applicable, since the deem18 ing of such tentative final monograph as a 

19 final administrative order under paragraph 

20 (6)). 

21 ‘‘(C) HEARING PROCEDURES.— 

22 ‘‘(i) DENIAL OF REQUEST FOR HEAR23 ING.—If the Secretary determines that a re24 quest for a hearing under subparagraph (A) 

25 with respect to a final administrative order 


sradovich on DSK3GMQ082PROD with BILLS
110 

•S 2315 RS

1 issued under paragraph (2)(A)(iv), does not 

2 establish the existence of a genuine and sub3 stantial question of material fact, the Sec4 retary may deny such request. In making 

5 such a determination, the Secretary may 

6 consider only information and data that 

7 are based on relevant and reliable scientific 

8 principles and methodologies. 

9 ‘‘(ii) SINGLE HEARING FOR MULTIPLE

10 RELATED REQUESTS.—If more than one re11 quest for a hearing is submitted with re12 spect to the same administrative order 

13 under subparagraph (A), the Secretary may 

14 direct that a single hearing be conducted in 

15 which all persons whose hearing requests 

16 were granted may participate. 

17 ‘‘(iii) PRESIDING OFFICER.—The Sec18 retary shall designate a presiding officer of 

19 a hearing requested under subparagraph 

20 (A) who— 

21 ‘‘(I) is not an employee of the 

22 Center for Drug Evaluation and Re23 search; and 

24 ‘‘(II) has not previously been in25 volved in the development of the appliVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00110 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
111 

•S 2315 RS

1 cable administrative order or in the 

2 proceedings relating to that adminis3 trative order. 

4 ‘‘(iv) RIGHTS OF PARTIES TO HEAR5 ING.—The parties to a hearing requested 

6 under subparagraph (A) shall have the right 

7 to present testimony, including testimony of 

8 expert witnesses, and to cross-examine wit9 nesses presented by other parties. Where ap10 propriate, the presiding officer may require 

11 that cross-examination by parties rep12 resenting substantially the same interests be 

13 consolidated to promote efficiency and avoid 

14 duplication. 

15 ‘‘(v) FINAL DECISION.—At the conclu16 sion of a hearing requested under subpara17 graph (A), the presiding officer of the hear18 ing shall issue a decision containing find19 ings of fact and conclusions of law. The de20 cision of the presiding officer shall be final. 

21 The final decision may not take effect until 

22 the period under subparagraph (D)(ii) for 

23 submitting a request for judicial review of 

24 such decision expires. 


sradovich on DSK3GMQ082PROD with BILLS
112 

•S 2315 RS

1 ‘‘(D) JUDICIAL REVIEW OF FINAL ADMINIS2 TRATIVE ORDER.— 

3 ‘‘(i) IN GENERAL.—The procedures de4 scribed in section 505(h) shall apply with 

5 respect to judicial review of final adminis6 trative orders issued under this subsection 

7 in the same manner and to the same extent 

8 as such section applies to an order described 

9 in such section except that the judicial re10 view shall be taken by filing in an appro11 priate district court of the United States in 

12 lieu of the appellate courts specified in such 

13 section. 

14 ‘‘(ii) TIME TO SUBMIT A REQUEST FOR

15 JUDICIAL REVIEW.—A person eligible to re16 quest a hearing under this paragraph and 

17 seeking judicial review of a final adminis18 trative order issued under this subsection 

19 shall file a request for such review not later 

20 than 60 calendar days after the latest of— 

21 ‘‘(I) the date on which notice of 

22 such order is published; 

23 ‘‘(II) the date on which any hear24 ing with respect to such order is denied 

25 under subparagraph (C)(i); 


sradovich on DSK3GMQ082PROD with BILLS
113 

•S 2315 RS

1 ‘‘(III) the date on which a final 

2 decision is made following any hearing 

3 with respect to such order under sub4 paragraph (C)(v); or 

5 ‘‘(IV) if no hearing is requested, 

6 the date on which the time for request7 ing a hearing expires. 

8 ‘‘(4) EXPEDITED PROCEDURE WITH RESPECT TO

9 ADMINISTRATIVE ORDERS INITIATED BY THE SEC10 RETARY.— 

11 ‘‘(A) IMMINENT HAZARD TO THE PUBLIC

12 HEALTH.— 

13 ‘‘(i) IN GENERAL.—In the case of a de14 termination by the Secretary that a mono15 graph drug poses an imminent hazard to 

16 the public health, the Secretary, after infor17 mally communicating with any sponsor 

18 that has a listing in effect under section 

19 510(j) for such drug not later than 48 hours 

20 before issuance of an order under this sub21 paragraph, may— 

22 ‘‘(I) issue an interim final ad23 ministrative order for such drug or 

24 combination of drugs under paragraph 


sradovich on DSK3GMQ082PROD with BILLS
114 

•S 2315 RS

1 (1), together with a detailed statement 

2 of the reasons for such order; 

3 ‘‘(II) publish in the Federal Reg4 ister a notice of availability of such 

5 order; and 

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

8 days after issuance of such interim 

9 final order. 

10 ‘‘(ii) NONDELEGATION.—The Secretary 

11 may not delegate the authority to issue an 

12 interim final administrative order under 

13 this subparagraph. 

14 ‘‘(B) SAFETY LABELING CHANGES.— 

15 ‘‘(i) IN GENERAL.—In the case of a de16 termination by the Secretary that a change 

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

18 combination of drugs subject to this section 

19 is reasonably expected to mitigate a signifi20 cant or unreasonable risk of a serious ad21 verse event associated with use of the drug, 

22 the Secretary may— 

23 ‘‘(I) informally communicate, not 

24 later than 48 hours before issuance of 

25 an interim final order under this subVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00114 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
115 

•S 2315 RS

1 paragraph any sponsors of a drug who 

2 has a listing in effect under section 

3 510(j) for such drug or combination of 

4 drugs; 

5 ‘‘(II) after informally commu6 nicating with the sponsors under sub7 clause (I), issue an interim final ad8 ministrative order under paragraph 

9 (1) to require such change, together 

10 with a detailed statement of the rea11 sons for such order and, in the case of 

12 a required change to the packaging, a 

13 brief description of the factors consid14 ered in accordance with paragraph 

15 (7)(B)(i); 

16 ‘‘(III) publish in the Federal Reg17 ister a notice of availability of such 

18 order; and 

19 ‘‘(IV) provide for a public com20 ment period of at least 45 calendar 

21 days after issuance of such interim 

22 final order. 

23 ‘‘(ii) CONTENT OF ORDER.—An in24 terim final order issued under this subpara25 graph with respect to the labeling of a drug 


sradovich on DSK3GMQ082PROD with BILLS
116 

•S 2315 RS

1 may provide for new warnings and other 

2 information required for safe use of the 

3 drug. 

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

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

6 date specified by the Secretary. 

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

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

9 the Secretary shall— 

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

11 with paragraph (1); 

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

13 such final administrative order in the Fed14 eral Register; and 

15 ‘‘(iii) afford sponsors of drugs that will 

16 be subject to such an order the opportunity 

17 for formal dispute resolution up to the level 

18 of the Director of the Center for Drug Eval19 uation and Research, which initially shall 

20 be within 45 calendar days of the issuance 

21 of the order; and, for subsequent levels of 

22 appeal, within 30 calendar days of the 

23 prior decision. 

24 ‘‘(E) HEARINGS.— 


sradovich on DSK3GMQ082PROD with BILLS
117 

•S 2315 RS

1 ‘‘(i) IN GENERAL.—A sponsor of a 

2 drug subject to a final order issued under 

3 subparagraph (D) who participated in each 

4 level of formal dispute resolution under sub5 paragraph (D)(iii) may request a hearing 

6 on such order. The provisions of subpara7 graphs (A), (B), and (C) of paragraph (3) 

8 shall apply with respect to a hearing on 

9 such order in the same manner and to the 

10 same extent as such provisions apply with 

11 respect to a hearing on an administrative 

12 order issued under paragraph (2)(A)(iv), 

13 except that, with respect to a final order 

14 issued under subparagraph (D), the final 

15 decision under paragraph (3)(C)(v) may 

16 take effect prior to the expiration of the pe17 riod under paragraph (3)(D)(ii) for submit18 ting a request for judicial review. 

19 ‘‘(ii) REFERENCES.—For purposes of a 

20 hearing under this subparagraph, the ref21 erences in subparagraphs (A), (B), and (C) 

22 of paragraph (3)— 

23 ‘‘(I) to ‘each level of dispute reso24 lution under paragraph 

25 (2)(A)(iv)(III)’ shall be deemed to 


sradovich on DSK3GMQ082PROD with BILLS
118 

•S 2315 RS

1 mean ‘each level of formal dispute reso2 lution under subparagraph (D)(iii)’; 

3 and 

4 ‘‘(II) to ‘final administrative 

5 order issued under paragraph 

6 (2)(A)(iv)’ shall be deemed to mean 

7 ‘final order under subparagraph 

8 (D)(i)’. 

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

10 after the date on which an interim final order is 

11 issued under subparagraph (A) or (B), the Sec12 retary shall issue a final order in accordance 

13 with paragraph (1) and complete any required 

14 hearing. 

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

16 issued pursuant to subparagraph (F) shall be 

17 subject to judicial review in accordance with 

18 paragraph (3)(D). 

19 ‘‘(H) CLARIFICATION.—Paragraph (2) shall 

20 not apply to the orders issued under this para21 graph. 

22 ‘‘(5) ADMINISTRATIVE ORDER INITIATED BY RE23 QUEST.— 

24 ‘‘(A) IN GENERAL.—In issuing an adminis25 trative order under paragraph (1) at the request 


sradovich on DSK3GMQ082PROD with BILLS
119 

•S 2315 RS

1 of a requestor or a group of requestors with re2 spect to certain drugs, classes of drugs, or com3 binations of drugs— 

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

5 a request under this subparagraph, deter6 mine whether the request is sufficiently 

7 complete and formatted to permit a sub8 stantive review; 

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

10 the Secretary determines that the request is 

11 sufficiently complete and formatted to per12 mit a substantive review, the Secretary 

13 shall— 

14 ‘‘(I) file the request; and 

15 ‘‘(II) initiate proceedings with re16 spect to issuing an administrative 

17 order in accordance with paragraphs 

18 (2) and (3); and 

19 ‘‘(iii) except as provided in subpara20 graph (D)(v), if the Secretary determines 

21 that a request does not meet the require22 ments for filing or is not sufficiently com23 plete or formatted to permit a substantive 

24 review, the requestor may elect that the Sec25 retary file the request over protest, and the 


sradovich on DSK3GMQ082PROD with BILLS
120 

•S 2315 RS

1 Secretary shall initiate proceedings to re2 view the request in accordance with para3 graph (2)(A). 

4 ‘‘(B) REQUEST TO INITIATE PRO5 CEEDINGS.— 

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

7 an administrative order with respect to cer8 tain drugs, classes of drugs, or combinations 

9 of drugs, shall submit to the Secretary a re10 quest to initiate proceedings for such order 

11 in the form and manner as specified by the 

12 Secretary. Such requestor may submit a re13 quest under this subparagraph for the 

14 issuance of an administrative order— 

15 ‘‘(I) determining whether a drug 

16 is generally recognized as safe and ef17 fective within the meaning of section 

18 201(p)(1), exempt from section 

19 503(b)(1), and not required to be the 

20 subject of an approved application 

21 under section 505; or 

22 ‘‘(II) determining whether a 

23 change to a condition of use or a new 

24 condition of use of a drug is generally 

25 recognized as safe and effective within 


sradovich on DSK3GMQ082PROD with BILLS
121 

•S 2315 RS

1 the meaning of section 201(p)(1), ex2 empt from section 503(b)(1), and not 

3 required to be the subject of an ap4 proved application under section 505, 

5 if such drug is— 

6 ‘‘(aa) described in subsection 

7 (b)(1)(A); or 

8 ‘‘(bb) described in subsection 

9 (b)(1)(B), but only if such re10 questor initiates such request in 

11 conjunction with a request for the 

12 Secretary to determine whether 

13 such drug is generally recognized 

14 as safe and effective within the 

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

16 which is filed by the Secretary 

17 under subparagraph (A)(ii)(I). 

18 The Secretary is not required to complete 

19 review of the request for a change described 

20 in subclause (II) if the Secretary deter21 mines, in accordance with paragraph 

22 (1)(B), that there is an inadequate basis to 

23 find the drug is generally recognized as safe 

24 and effective under paragraph (1) and 


sradovich on DSK3GMQ082PROD with BILLS
122 

•S 2315 RS

1 issues a final order announcing that deter2 mination. 

3 ‘‘(ii) WITHDRAWAL OF REQUEST.—The 

4 requestor may withdraw a request under 

5 this paragraph, according to the procedures 

6 established by the Secretary. Notwith7 standing any other provision of this section, 

8 if such request is withdrawn, the Secretary 

9 may cease proceedings under this subpara10 graph. 

11 ‘‘(C) PRODUCT DIFFERENTIATION.— 

12 ‘‘(i) IN GENERAL.—A final adminis13 trative order issued in response to a request 

14 under this paragraph shall have the effect of 

15 authorizing solely the order requestor (or the 

16 licensees, assignees, or successors in interest 

17 of such requestor with respect to the subject 

18 of such order and listed under clause (v)), 

19 for a 2-year period beginning on the effec20 tive date of such order, to market drugs 

21 under this section— 

22 ‘‘(I) incorporating changes de23 scribed in clause (ii); and 

24 ‘‘(II) subject to the limitations 

25 under clause (iv). 


sradovich on DSK3GMQ082PROD with BILLS
123 

•S 2315 RS

1 ‘‘(ii) CHANGES DESCRIBED.—A change 

2 described in this clause is a change subject 

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

4 ‘‘(I) provides for a drug to con5 tain an active ingredient (including 

6 any ester or salt of the active ingre7 dient) not previously incorporated in a 

8 drug described in clause (iii); or 

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

10 conditions of use of a drug, for which 

11 new human data studies conducted or 

12 sponsored by the requestor (or for 

13 which the requestor has an exclusive 

14 right of reference) were essential to the 

15 issuance of such order. 

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

17 described in this clause are drugs— 

18 ‘‘(I) specified in subparagraphs 

19 (A), (B), and (D) of subsection (b)(1); 

20 ‘‘(II) subject to a final order 

21 issued under this section; 

22 ‘‘(III) subject to a final sunscreen 

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

24 or 


sradovich on DSK3GMQ082PROD with BILLS
124 

•S 2315 RS

1 ‘‘(IV) described in subsection 

2 (b)(4)(A), other than drugs subject to 

3 an active enforcement action under 

4 chapter III. 

5 ‘‘(iv) LIMITATIONS ON PRODUCT DIF6 FERENTIATION.— 

7 ‘‘(I) ONLY ONE PERIOD.—Only 

8 one 2-year period under this subpara9 graph shall be granted for each order 

10 described in clause (i) with respect to 

11 changes (to the drug subject to such 

12 order) that are— 

13 ‘‘(aa) changes described in 

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

15 ingredients; or 

16 ‘‘(bb) changes described in 

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

19 ‘‘(II) EXCLUSIONS.—No 2-year 

20 period under this subparagraph shall 

21 apply to changes to a drug that are— 

22 ‘‘(aa) the subject of a ‘Tier 2’ 

23 monograph drug order requested 

24 as described in section 

25 744L(14)(A); 


sradovich on DSK3GMQ082PROD with BILLS
125 

•S 2315 RS

1 ‘‘(bb) safety-related changes 

2 described in section 744L– 

3 1(a)(2)(C), required under this 

4 paragraph, or any other change 

5 the Secretary determines nec6 essary to ensure safe use; or 

7 ‘‘(cc) changes related to 

8 methods of testing safety or effi9 cacy. 

10 ‘‘(v) LISTING OF LICENSEES, ASSIGN11 EES, OR SUCCESSORS IN INTEREST.—The 

12 requestors of an order described in clause (i) 

13 shall, as applicable, submit to the Secretary, 

14 at a time when a drug subject to such order 

15 is introduced or delivered for introduction 

16 into interstate commerce, a list of licensees, 

17 assignees, or successors in interest under 

18 such clause. 

19 ‘‘(vi) NEW HUMAN DATA STUDIES DE20 FINED.—For purposes of this subparagraph, 

21 the term ‘new human data studies’ means 

22 studies from clinical trials of safety or effec23 tiveness, pharmacokinetics studies, or bio24 availability studies, the results of which— 


sradovich on DSK3GMQ082PROD with BILLS
126 

•S 2315 RS

1 ‘‘(I) the Secretary has not relied 

2 on to support— 

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

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

6 clause (iii) is generally recognized 

7 as safe and effective within the 

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

9 ‘‘(bb) approval of a drug 

10 under section 505; and 

11 ‘‘(II) do not duplicate the results 

12 of another study that the Secretary re13 lied on to support— 

14 ‘‘(aa) a proposed or final de15 termination that a drug described 

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

17 clause (iii) is generally recognized 

18 as safe and effective within the 

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

20 ‘‘(bb) approval of a drug that 

21 was approved under section 505. 

22 ‘‘(D) INFORMATION REGARDING SAFE NON23 PRESCRIPTION MARKETING AND USE AS A CONDI24 TION FOR FILING A GRASE REQUEST.— 


sradovich on DSK3GMQ082PROD with BILLS
127 

•S 2315 RS

1 ‘‘(i) IN GENERAL.—In response to a re2 quest under this paragraph that a drug de3 scribed in clause (ii) be generally recognized 

4 as safe and effective, the Secretary— 

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

6 request includes information specified 

7 under clause (iii) with respect to safe 

8 nonprescription marketing and use of 

9 such drug; or 

10 ‘‘(II) if the request fails to include 

11 information specified under clause 

12 (iii), shall refuse to file such request 

13 and may require that nonprescription 

14 marketing of the drug be pursuant to 

15 a new drug application as described in 

16 clause (iv). 

17 ‘‘(ii) DRUG DESCRIBED.—A drug de18 scribed in this clause is a monograph drug 

19 that contains an active ingredient not pre20 viously incorporated in a drug— 

21 ‘‘(I) described in subparagraph 

22 (A), (B), or (D) of subsection (b)(1); 

23 ‘‘(II) subject to a final order 

24 under this section; or 


sradovich on DSK3GMQ082PROD with BILLS
128 

•S 2315 RS

1 ‘‘(III) subject to a final sunscreen 

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

3 ‘‘(iii) SUFFICIENT INFORMATION FOR A

4 THRESHOLD DEMONSTRATION OF NON5 PRESCRIPTION MARKETING AND USE.—In6 formation specified in this subparagraph, 

7 with respect to a request described in clause 

8 (i)(I), is— 

9 ‘‘(I) information sufficient for a 

10 threshold demonstration that the drug 

11 subject to such request has a verifiable 

12 history of being marketed and safely 

13 used by consumers in the United States 

14 as a nonprescription drug under com15 parable conditions of use; 

16 ‘‘(II) if the drug has not been pre17 viously marketed in the United States 

18 as a nonprescription drug, information 

19 sufficient for a threshold demonstration 

20 that the drug was marketed and safely 

21 used in a foreign country under condi22 tions of marketing and use— 

23 ‘‘(aa) for such period of time 

24 as needed to provide reasonable 

25 assurances concerning the safe 


sradovich on DSK3GMQ082PROD with BILLS
129 

•S 2315 RS

1 nonprescription use of the drug; 

2 and 

3 ‘‘(bb) during such period of 

4 time, was subject to sufficient 

5 monitoring by a regulatory body 

6 of any country listed in section 

7 802(b)(1)(A) or any country des8 ignated by the Secretary in ac9 cordance with section 

10 802(b)(1)(B); or 

11 ‘‘(III) if the Secretary determines 

12 that information described in subclause 

13 (I) or (II) is not needed to provide a 

14 threshold demonstration that the drug 

15 can be safely marketed and used as a 

16 nonprescription drug, other informa17 tion the Secretary determines sufficient 

18 for such purposes. 

19 ‘‘(iv) MARKETING PURSUANT TO NEW

20 DRUG APPLICATION.—In the case of a re21 quest described in clause (i)(II), the drug 

22 subject to such request may be re-submitted 

23 for filing only if— 

24 ‘‘(I) the drug is marketed as a 

25 nonprescription drug, under conditions 


sradovich on DSK3GMQ082PROD with BILLS
130 

•S 2315 RS

1 of use comparable to the requirements 

2 specified in the request, for such period 

3 of time as the Secretary determines ap4 propriate (not to exceed 5 consecutive 

5 years) pursuant to an application ap6 proved under section 505; and 

7 ‘‘(II) during such period of time, 

8 1,000,000 retail packages of the drug, 

9 or an equivalent quantity of the active 

10 ingredient or ingredients of such drug 

11 as determined by the Secretary, were 

12 distributed for retail sale, as deter13 mined in such manner as the Secretary 

14 may require. 

15 ‘‘(v) RULE OF APPLICATION.—If the 

16 Secretary refuses to file a request under this 

17 subparagraph, the requestor may not file 

18 over protest under subparagraph (A)(iii) 

19 unless the request involves a drug described 

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

21 2017. 

22 ‘‘(6) TREATMENT OF FINAL AND TENTATIVE

23 FINAL MONOGRAPHS.— 

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

25 tentative final monograph described in subparaVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00130 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
131 

•S 2315 RS

1 graph (B) shall be deemed to be a final adminis2 trative order under this subsection and may be 

3 amended, revoked, or otherwise modified in ac4 cordance with the procedures of this subsection. 

5 ‘‘(B) MONOGRAPHS DESCRIBED.—For pur6 poses of subparagraph (A), a final monograph or 

7 tentative final monograph, as applicable, is de8 scribed in this subparagraph if such mono9 graph— 

10 ‘‘(i) establishes requirements of use for 

11 a drug described in subclause (I) or (II) of 

12 subsection (b)(1)(A)(i); and 

13 ‘‘(ii) represents the most recently pro14 mulgated version of such requirements, in15 cluding as modified, in whole or in part, by 

16 any proposed or final rule. 

17 ‘‘(7) PACKAGING.— 

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

19 order issued under paragraph (2), (4), or (5) 

20 may include requirements for the packaging of a 

21 drug, such as to promote use in accordance with 

22 labeling, unit dose packaging, or requirements to 

23 prevent overdose or accidental ingestion, includ24 ing by pediatric populations. 


sradovich on DSK3GMQ082PROD with BILLS
132 

•S 2315 RS

1 ‘‘(B) SAFETY LABELING CHANGES.—An ad2 ministrative order issued under paragraph 

3 (4)(B) that includes requirements for the pack4 aging of a drug may be issued only after— 

5 ‘‘(i) consideration of— 

6 ‘‘(I) whether labeling changes 

7 alone would mitigate a significant or 

8 unreasonable risk of a serious adverse 

9 event; and 

10 ‘‘(II) as appropriate, any of the 

11 applicable nonprescription drugs cur12 rently available; and 

13 ‘‘(ii) consultation with sponsors on the 

14 impact of the removal of such drugs without 

15 such packaging and the change of such 

16 packaging on patients and manufacturers 

17 when establishing such requirements. 

18 ‘‘(C) CLARIFICATION.—This paragraph does 

19 not authorize the Secretary to require standards 

20 or testing procedures as described in part 1700 

21 of title 16, Code of Federal Regulations. 

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

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

24 form of a drug that is described in subparagraph (A) 

25 or (B) of subsection (b)(1) may be made by a reVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00132 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
133 

•S 2315 RS

1 questor without the issuance of an administrative 

2 order under subsection (c) if— 

3 ‘‘(A) the requestor maintains information 

4 necessary to demonstrate that the change— 

5 ‘‘(i) will not affect the safety or effec6 tiveness of the drug; and 

7 ‘‘(ii) will not materially affect the ex8 tent of absorption or other exposure to the 

9 active ingredient in comparison to a suit10 able reference product; 

11 ‘‘(B) the requestor submits updated drug 

12 listing information for the drug in accordance 

13 with the requirements of section 510(j) within 30 

14 calendar days of the date on which the drug is 

15 first introduced into interstate commerce with 

16 the change; and 

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

18 requirements of an applicable administrative 

19 order issued by the Secretary under paragraph 

20 (3). 

21 ‘‘(2) ADDITIONAL INFORMATION.— 

22 ‘‘(A) ACCESS TO RECORDS.—If the Sec23 retary requests records under section 704(a)(4) 

24 with respect to a minor change made to a drug 

25 by a requestor under this subsection, any such 


sradovich on DSK3GMQ082PROD with BILLS
134 

•S 2315 RS

1 records pertinent to such drug, such minor 

2 change, and the requestor shall be provided to the 

3 Secretary by the requestor within 15 business 

4 days of receiving such request, or such longer pe5 riod as the Secretary may provide. 

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

7 Secretary determines that the information con8 tained in such records is not sufficient to dem9 onstrate that the change does not affect the safety 

10 or effectiveness of the drug or materially affect 

11 the extent of absorption or other exposure to the 

12 active ingredient, the Secretary— 

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

14 drug in writing; and 

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

16 with a reasonable opportunity to provide 

17 additional information. 

18 ‘‘(C) FAILURE TO SUBMIT SUFFICIENT IN19 FORMATION.—If the requestor fails to provide 

20 such additional information within the pre21 scribed time, or if the Secretary determines that 

22 such additional information does not dem23 onstrate that the change does not affect the safety 

24 or effectiveness of the drug or materially affect 

25 the extent of absorption or other exposure to the 


sradovich on DSK3GMQ082PROD with BILLS
135 

•S 2315 RS

1 active ingredient, the drug as modified is a new 

2 drug within the meaning of section 201(p) and 

3 shall be deemed to be misbranded under section 

4 502(ee). 

5 ‘‘(3) DETERMINING WHETHER CHANGE WILL AF6 FECT SAFETY OR EFFECTIVENESS.— 

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

8 issue one or more administrative orders under 

9 this subsection specifying requirements for deter10 mining whether a minor change made by a re11 questor pursuant to this subsection will affect the 

12 safety or effectiveness of a drug or materially af13 fect the extent of absorption or other exposure to 

14 an active ingredient in the drug in comparison 

15 to a suitable reference product, together with 

16 guidance for applying those orders to specific 

17 dosage forms. 

18 ‘‘(B) STANDARD PRACTICES AND SPECIAL

19 NEEDS OF POPULATIONS.—The orders and guid20 ance issued by the Secretary under subparagraph 

21 (A) shall take into account relevant public stand22 ards and standard practices for evaluating the 

23 quality of drug products and may take into ac24 count special needs of populations, including 

25 children. 


sradovich on DSK3GMQ082PROD with BILLS
136 

•S 2315 RS

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

2 ‘‘(1) CONFIDENTIAL INFORMATION.—Subject to 

3 paragraph (2), any information, including reports of 

4 testing conducted on the drug or drugs involved, that 

5 is submitted by a requestor in connection with pro6 ceedings on an administrative order under this sec7 tion (or any minor change under subsection (d)) and 

8 is a trade secret or confidential information subject to 

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

10 section 1905 of title 18, United States Code, shall not 

11 be disclosed to the public unless the requestor consents 

12 to that disclosure. 

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

14 Secretary shall make available to the public any in15 formation (other than information contained in sub16 ject-level data sets, such as those derived from indi17 vidual case report forms) submitted by a requestor in 

18 support of a request under subsection (c)(6)(A) as of 

19 the date on which the proposed order is issued un20 less— 

21 ‘‘(A) the information pertains to pharma22 ceutical quality, unless such information is nec23 essary to establish standards under which a drug 

24 is generally recognized as safe and effective with25 in the meaning of section 201(p)(1); 


sradovich on DSK3GMQ082PROD with BILLS
137 

•S 2315 RS

1 ‘‘(B) the information is submitted in a re2 questor-initiated request, but the requestor with3 draws such request before the Secretary issues the 

4 proposed order in accordance with withdrawal 

5 procedures established by the Secretary; or 

6 ‘‘(C) the Secretary requests and obtains the 

7 information under subsection (d) and such infor8 mation is not submitted in relation to an order 

9 under subsection (c). 

10 ‘‘(f) PUBLIC AVAILABILITY OF ADMINISTRATIVE OR11 DERS.—The Secretary shall establish, maintain, update (as 

12 the Secretary determines necessary, but not less frequently 

13 than annually), and make available on the internet website 

14 of the Food and Drug Administration— 

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

16 order and interim final order issued under subsection 

17 (c) that is in effect, including the complete text of the 

18 administrative order; and 

19 ‘‘(2) a listing of all administrative orders pro20 posed and under development on the initiative of the 

21 Secretary under this section, including— 

22 ‘‘(A) a brief description of the administra23 tive order; and 


sradovich on DSK3GMQ082PROD with BILLS
138 

•S 2315 RS

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.—A 

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

6 shall submit updated drug listing information for the drug 

7 in accordance with the requirements of section 510(j) not 

8 later than the date on which the drug is first introduced 

9 or delivered for introduction into interstate commerce with 

10 the change. 

11 ‘‘(h) APPROVALS UNDER SECTION 505.—This section 

12 shall not be construed to preclude a sponsor of a drug or 

13 requestor from seeking or maintaining the approval of an 

14 application for such drug under subsection (b)(1), (b)(2), 

15 or (j) of section 505. A determination under this section 

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

17 recognized as safe and effective within the meaning of sec18 tion 201(p)(1), and is not a new drug under section 201(p), 

19 shall constitute a finding of safety and effectiveness for pur20 poses of section 505(b)(2) so that the applicant shall be re21 quired to submit only that information needed to support 

22 the modification of the drug that is subject to the determina23 tion under this section. 

24 ‘‘(i) DEVELOPMENT ADVICE TO REQUESTORS OR

25 SPONSORS.— 


sradovich on DSK3GMQ082PROD with BILLS
139 

•S 2315 RS

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

2 procedures under which requestors may meet with ap3 propriate officials of the Food and Drug Administra4 tion to obtain advice on the studies and other infor5 mation necessary to support requests under this sec6 tion and other matters relevant to the regulation and 

7 development of monograph drugs under this section. 

8 ‘‘(2) PARTICIPATION OF MULTIPLE SPONSORS.— 

9 The Secretary shall establish procedures to facilitate 

10 efficient participation by multiple requestors in pro11 ceedings under this section, including provision for 

12 joint meetings with multiple requestors or with orga13 nizations nominated by requestors to represent their 

14 interests in a proceeding. 

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

16 The procedures established under this subsection shall 

17 include appropriate provision for confidential meet18 ings with requestors with respect to discussion of mat19 ters involving confidential commercial information or 

20 trade secrets. 

21 ‘‘(j) EFFECT ON EXISTING REGULATIONS GOVERNING

22 NONPRESCRIPTION DRUGS.— 

23 ‘‘(1) REGULATIONS OF GENERAL APPLICABILITY

24 TO NONPRESCRIPTION DRUGS.—Except as provided in 

25 this subsection, nothing in this section supersedes regVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00139 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
140 

•S 2315 RS

1 ulations establishing general requirements for non2 prescription drugs, including regulations of general 

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

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

5 regulations. The Secretary shall establish or modify 

6 such regulations by means of rulemaking in accord7 ance with section 553 of title 5, United States Code. 

8 ‘‘(2) REGULATIONS ESTABLISHING REQUIRE9 MENTS FOR SPECIFIC NONPRESCRIPTION DRUGS.— 

10 ‘‘(A) IN GENERAL.—Section 310.545 of title 

11 21, Code of Federal Regulations, as in effect on 

12 the day before the date of enactment of this sec13 tion, shall be deemed to be final administrative 

14 order under subsection (c). 

15 ‘‘(B) OTHER REGULATIONS.—Regulations 

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

18 section that are in effect on the day before the 

19 date of enactment of this section (including such 

20 requirements in parts 201, 250, and 330 of title 

21 21, Code of Federal Regulations), shall be deemed 

22 to be final administrative orders under sub23 section (c) only as such requirements apply to 

24 monograph drugs subject to this section. 


sradovich on DSK3GMQ082PROD with BILLS
141 

•S 2315 RS

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

2 withdrawn or revised by the Secretary, the regu3 lations under title 21 of the Code of Federal Reg4 ulations that are described in subparagraph (B) 

5 shall remain in effect with respect to drugs not 

6 subject to subparagraph (A), (B), (C), or (D) of 

7 subsection (b)(1). 

8 ‘‘(3) WITHDRAWAL OF REGULATIONS.—The Sec9 retary shall withdraw regulations establishing final 

10 monographs and the procedures governing the over11 the-counter drug review under part 330 and other rel12 evant parts of title 21, Code of Federal Regulations 

13 (as in effect on the day before the date of enactment 

14 of the Over-the-Counter Drug Safety, Innovation, and 

15 Reform Act), or make technical changes to such regu16 lations to ensure conformity with appropriate termi17 nology and cross references, to the extent needed to ef18 fectuate or harmonize the provisions of this section. 

19 Notwithstanding subchapter II of chapter 5 of title 5, 

20 United States Code, any such withdrawal or technical 

21 amendments shall be made without public notice and 

22 comment and be effective upon publication through 

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

24 specified in such notice). 

25 ‘‘(k) GUIDANCE.— 


sradovich on DSK3GMQ082PROD with BILLS
142 

•S 2315 RS

1 ‘‘(1) ISSUANCE.—The Secretary shall issue guid2 ance that provides— 

3 ‘‘(A) the procedures and principles for for4 mal meetings between the Secretary and sponsors 

5 or requestors for drugs subject to this section; 

6 ‘‘(B) the format and content of data submis7 sions to the Secretary under this section; 

8 ‘‘(C) the format of electronic submissions to 

9 the Secretary under this section; 

10 ‘‘(D) consolidated proceedings and the pro11 cedures for such proceedings where appropriate; 

12 and 

13 ‘‘(E) for minor changes in drugs, rec14 ommendations on how to comply with the re15 quirements in administrative orders issued 

16 under subsection (d)(3)(A). 

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

18 this section shall be in an electronic format specified by the 

19 Secretary after providing a period for public comment. 

20 ‘‘(m) INAPPLICABILITY OF PAPERWORK REDUCTION

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

22 apply to collections of information made under this section. 

23 ‘‘(n) NONAPPLICATION OF CERTAIN REQUIREMENTS.— 

24 The requirements of subchapter II of chapter 5 of title 5, 


sradovich on DSK3GMQ082PROD with BILLS
143 

•S 2315 RS

1 United States Code, shall not apply with respect to admin2 istrative orders issued under this section. 

3 ‘‘(o) INVESTIGATIONAL NEW DRUGS.—A drug for 

4 which an exemption under section 505(i) is in effect is not 

5 subject to this section.’’. 

6 SEC. 102. MISBRANDING. 

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

8 Act (21 U.S.C. 352) is amended by inserting after sub9 section (dd) the following: 

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

11 subject of an application approved under section 505, and 

12 does not comply with the requirements under section 505G. 

13 ‘‘(ff) If it is a drug for which fees under section 744L– 

14 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 SUB18 JECT TO SUNSCREEN INNOVATION ACT.— 

19 (1) PENDING SUNSCREEN INGREDIENTS.—Non20 prescription sunscreen active ingredients or combina21 tions of sunscreen active ingredients for use under 

22 specified conditions subject, on the date of enactment 

23 of this Act, to a proposed sunscreen order, as defined 

24 in section 586(7) of the Federal Food, Drug, and Cos25 metic Act (21 U.S.C. 360fff(7)), shall— 


sradovich on DSK3GMQ082PROD with BILLS
144 

•S 2315 RS

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 such 

5 Act upon written notification of the Secretary by 

6 the sponsor within 180 calendar days after the 

7 date of enactment of the Over-the-Counter Drug 

8 Safety, Innovation, and Reform Act that such 

9 sponsor elects to have such ingredient or com10 bination of ingredients reviewed under such sec11 tion 505G, and, upon notification, such proposed 

12 sunscreen order under such section 586C shall be 

13 considered to be a request for an administrative 

14 order that has been accepted for filing under sec15 tion 505G(c)(6)(A)(ii) of such Act. 

16 (2) PENDING NONSUNSCREEN INGREDIENTS.— 

17 (A) IN GENERAL.—Any application de18 scribed in section 586F of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 360fff–6) 

20 that was submitted to the Secretary of Health 

21 and Human Services pursuant to section 330.14 

22 of title 21, Code of Federal Regulations (as such 

23 provisions were in effect on the day before the 

24 date of enactment of this Act), shall be voided as 


sradovich on DSK3GMQ082PROD with BILLS
145 

•S 2315 RS

1 of such date of enactment, subject to subpara2 graph (B). 

3 (B) ORDER REQUEST.—Nothing in sub4 paragraph (A) precludes the submission of an 

5 order request under section 505G(b) of the Fed6 eral Food, Drug, and Cosmetic Act, as added by 

7 section 101 of this Act, with respect to a drug 

8 that was the subject of an application voided 

9 under subparagraph (A). 

10 (C) INGREDIENTS SUBMITTED AFTER THE

11 DATE OF ENACTMENT OF SECTION 506G.—Any 

12 ingredient that is eligible for review under sec13 tion 505G of the Federal Food, Drug, and Cos14 metic Act and is submitted after the date of en15 actment of this Act shall be considered under 

16 that section. 

17 (b) MEETINGS REGARDING SUNSCREEN INGREDI18 ENTS.—Section 586C(b) of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 360fff–3(b)) is amended by adding 

20 at the end the following: 

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

22 may request an individual, confidential meeting to 

23 discuss the data requirements to support a general 

24 recognition of safety and effectiveness with respect to 

25 the subject of a pending sunscreen ingredient. The 


sradovich on DSK3GMQ082PROD with BILLS
146 

•S 2315 RS

1 Secretary shall respond within 14 calendar days of 

2 the request and schedule such meeting within 45 cal3 endar days, or within such timeline as specified in 

4 the letters described in section 201 of the Over-the5 Counter Drug Safety, Innovation, and Reform Act. If 

6 a sponsor requests more than one confidential meeting 

7 for the same proposed sunscreen order, the Secretary 

8 may refuse to grant an additional confidential meet9 ing request if the Secretary determines such addi10 tional confidential meeting is not reasonably nec11 essary for the sponsor to advance the proposed sun12 screen order, or if the sponsor does not provide suffi13 cient information upon which to base a substantive 

14 discussion. The Secretary shall publish a post-meeting 

15 summary on the internet website of the Food and 

16 Drug Administration of any confidential meeting 

17 that does not disclose confidential business informa18 tion.’’. 

19 (c) PRODUCT DIFFERENTIATION.—Section 586C of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff– 

21 3) is amended by adding at the end the following: 

22 ‘‘(f) PRODUCT DIFFERENTIATION.— 

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

24 have the effect of authorizing solely the order requestor 

25 (or the licensees, assignees, or successors in interest of 


sradovich on DSK3GMQ082PROD with BILLS
147 

•S 2315 RS

1 such requestor with respect to the subject of such re2 quest and listed under paragraph (5)) for a period of 

3 2 years, to market a sunscreen ingredient under this 

4 section incorporating changes described in paragraph 

5 (2) subject to the limitations under paragraph (4), be6 ginning on the date the requestor (or any licensees, 

7 assignees, or successors in interest of such requestor 

8 with respect to the subject of such request and listed 

9 under paragraph (5)) may lawfully market such sun10 screen ingredient pursuant to the order. 

11 ‘‘(2) CHANGES DESCRIBED.—A change described 

12 in this paragraph is a change subject to an order 

13 specified in paragraph (1) that permits a sunscreen 

14 to contain an active sunscreen ingredient not pre15 viously incorporated in a marketed sunscreen listed 

16 in paragraph (3). 

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

18 sunscreen ingredients described this paragraph are 

19 sunscreen ingredients— 

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

21 monograph for sunscreen drug products set forth 

22 at part 352 of title 21, Code of Federal Regula23 tions (as published at 64 Fed. Reg. 27687); or 

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

25 order issued under this section. 


sradovich on DSK3GMQ082PROD with BILLS
148 

•S 2315 RS

1 ‘‘(4) LIMITATIONS ON PRODUCT DIFFERENTIA2 TION.—Only one 2-year period may be granted per 

3 ingredient under paragraph (1). 

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

5 SUCCESSORS IN INTEREST.—Requestors shall submit 

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

7 such request is introduced or delivered for introduc8 tion into interstate commerce, a list of licensees, as9 signees, or successors in interest under paragraph 

10 (1).’’. 

11 (d) SUNSCREEN INNOVATION ACT AMENDMENTS.— 

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

13 Act (21 U.S.C. 360fff–3(e)) is amended by striking para14 graph (3) and inserting the following: 

15 ‘‘(3) RELATIONSHIP TO ORDERS UNDER SECTION

16 505G.—A final sunscreen order shall be deemed to be 

17 a final administrative order under section 505G and 

18 subject to the applicable provisions under such section 

19 505G, including with respect to amendment of such 

20 order.’’. 

21 (e) PRECLUSION OF NEW SUNSCREEN SUBMISSIONS; 

22 OPTION TO TRANSFER SUBMISSIONS TO OTC MONOGRAPH

23 ORDER PROCESS.— 

24 (1) SUNSET.—Beginning on the date of enact25 ment of this Act, section 586A of the Federal Food, 


sradovich on DSK3GMQ082PROD with BILLS
149 

•S 2315 RS

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

2 have no force or effect. 

3 (2) OPTION TO TRANSFER SUBMISSIONS TO OTC

4 MONOGRAPH ORDER PROCESS.— 

5 (A) IN GENERAL.—Any person who sub6 mitted a request described in subparagraph (B) 

7 may, at any time prior to the sunset of sub8 chapter I of chapter V of the Federal Food, Drug, 

9 and Cosmetic Act (21 U.S.C. 360fff et seq.) 

10 under section 586H of such Act, withdraw such 

11 request from the process under such subchapter 

12 and resubmit such request as an order request 

13 under section 505G of such Act. 

14 (B) REQUESTS.—A request described in this 

15 subparagraph is— 

16 (i) a request under section 586A of the 

17 Federal Food, Drug, and Cosmetic Act sub18 mitted before the date of enactment of this 

19 Act; or 

20 (ii) a pending request described in sec21 tion 586(6). 

22 (f) TREATMENT OF AUTHORITY REGARDING FINALIZA23 TION OF SUNSCREEN MONOGRAPH.—Section 586E of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff– 

25 5) is amended to read as follows: 


sradovich on DSK3GMQ082PROD with BILLS
150 

•S 2315 RS

1 ‘‘SEC. 586E. SUNSCREEN ORDER. 

2 ‘‘(a) IN GENERAL.— 

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

4 Not later than November 26, 2019, the Secretary shall 

5 amend and revise the final administrative order con6 cerning nonprescription sunscreen (referred to in this 

7 section as the ‘sunscreen order’) for which the sub8 stance, prior to the date of enactment of the Over-the9 Counter Drug Safety, Innovation, and Reform Act, 

10 was marketed in accordance with a final monograph 

11 for sunscreen drug products set forth in part 352 of 

12 title 21, Code of Federal Regulations (as published at 

13 64 Fed. Reg. 27687) 

14 ‘‘(2) ISSUANCE OF REVISED SUNSCREEN ORDER; 

15 EFFECTIVE DATE.—A revised sunscreen order de16 scribed in paragraph (1) shall be— 

17 ‘‘(A) issued in accordance with the proce18 dures described in section 505G(c)(2); 

19 ‘‘(B) issued in proposed form not later than 

20 May 28, 2019; 

21 ‘‘(C) effective not later than November 26, 

22 2020; and 

23 ‘‘(D) issued by the Secretary at least 1 year 

24 prior to such effective date. 

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

26 under subsection (a) does not include provisions related to 


sradovich on DSK3GMQ082PROD with BILLS
151 

•S 2315 RS

1 the effectiveness of various sun protection factor levels, and 

2 does not address all dosage forms known to the Secretary 

3 to be used in sunscreens marketed in the United States 

4 without a new drug application approved under section 

5 505, the Secretary shall submit a report to the Committee 

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

7 and the Committee on Energy and Commerce of the House 

8 of Representatives on the rationale for omission of such pro9 visions from such order, and a plan and timeline to compile 

10 any information necessary to address such provisions 

11 through such order.’’. 

12 (g) SUNSET OF PROCESS UNDER SUNSCREEN INNOVA13 TION ACT.—Subchapter I of chapter V of the Federal Food, 

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

15 amended by subsection (f), is further amended by inserting 

16 at the end the following new section: 

17 ‘‘SEC. 586H. SUNSET. 

18 ‘‘This subchapter shall no longer be effective upon the 

19 later of— 

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

21 under this subchapter with respect to every request de22 scribed in section 586A(b)(2) (other than any with23 drawn requests and requests resubmitted as order re24 quests under section 505G); or 


sradovich on DSK3GMQ082PROD with BILLS
152 

•S 2315 RS

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

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

3 SEC. 104. DRUGS EXCLUDED FROM OVER-THE-COUNTER RE4 VIEW. 

5 (a) IN GENERAL.—Nothing in this Act (or the amend6 ments made by this Act) shall apply to any nonprescription 

7 drug which was excluded by the Food and Drug Adminis8 tration from the Over-the-Counter Drug Review in accord9 ance with the statement set out at page 9466 of volume 37 

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

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

12 shall be construed to preclude or limit the applicability of 

13 any provision of the Federal Food, Drug, and Cosmetic Act. 

14 SEC. 105. CONFORMING AMENDMENT. 

15 Section 751(d)(1) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 379r(d)(1)) is amended— 

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

18 (A) by striking ‘‘final regulation promul19 gated’’ and inserting ‘‘final order issued under 

20 section 505G’’; and 

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

22 (2) in subparagraph (A), by striking ‘‘regulation 

23 in effect’’ and inserting ‘‘regulation or order in ef24 fect’’. 


sradovich on DSK3GMQ082PROD with BILLS
153 

•S 2315 RS

1 SEC. 106. ANNUAL UPDATE TO CONGRESS ON APPROPRIATE 

2 PEDIATRIC INDICATION FOR CERTAIN COUGH 

3 AND COLD MONOGRAPH DRUGS. 

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

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

6 Secretary of Health and Human Services (referred to in 

7 this section as the ‘‘Secretary’’) shall submit to the Com8 mittee on Health, Education, Labor, and Pensions of the 

9 Senate and the Committee on Energy and Commerce of the 

10 House of Representatives a letter describing the progress of 

11 the Food and Drug Administration— 

12 (1) in evaluating the cough and cold monograph 

13 described in subsection (b) with respect to children 

14 under age 6; and 

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

16 monograph to address such children, through the ad17 ministrative order process under section 505G(c) of 

18 the Federal Food, Drug, and Cosmetic Act, as added 

19 by section 101. 

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

21 cough and cold monograph described in this subsection con22 sists of the conditions under which nonprescription drug 

23 products containing antitussive, expectorant, nasal decon24 gestant, or antihistamine active ingredients (or combina25 tions thereof) are generally recognized as safe and effective, 

26 as specified in part 341 of title 21, Code of Federal RegulaVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00153 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
154 

•S 2315 RS

1 tions (as in effect on the day before the date of enactment 

2 of this Act), and included in an administrative order 

3 deemed established under such section 505G(c) of the Fed4 eral Food, Drug, and Cosmetic Act. 

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

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

7 Secretary submits a letter under subsection (a) in which 

8 the Secretary indicates that the Food and Drug Adminis9 tration has completed its evaluation and revised, in a final 

10 administrative order, as applicable, the cough and cold 

11 monograph in accordance with this section. 

12 TITLE II—FEES RELATING TO 

13 MONOGRAPH DRUGS 

14 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

17 (b) FINDINGS.—The Congress finds that the fees au18 thorized by the amendments made in this title will be dedi19 cated toward the regulation of monograph drugs under sec20 tion 505G of the Federal, Food, Drug, and Cosmetic Act, 

21 as set forth in the goals identified for purposes of such sec22 tion, in the letters from the Secretary of Health and Human 

23 Services to the Chairman of the Committee on Health, Edu24 cation, Labor, and Pensions of the Senate and the Chair25 man of the Committee on Energy and Commerce of the 


sradovich on DSK3GMQ082PROD with BILLS
155 

•S 2315 RS

1 House of Representatives, as set forth in the Congressional 

2 Record. 

3 SEC. 202. AUTHORITY TO ASSESS AND USE FEES. 

4 Subchapter C of chapter VII of the Federal Food, 

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

6 by adding at the end the following: 

7 ‘‘PART 10—FEES RELATING TO MONOGRAPH 

8 DRUGS 

9 ‘‘SEC. 744L. DEFINITIONS. 

10 ‘‘For purposes of this part: 

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

12 that has a relationship with a second business entity 

13 if, directly or indirectly— 

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

15 power to control, the other business entity; or 

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

17 control, both of the business entities. 

18 ‘‘(2) the term ‘contract manufacturing organiza19 tion facility’ means a monograph drug facility where 

20 neither the owner of such manufacturing facility nor 

21 any affiliate of such owner or facility sells such mono22 graph drug produced at such facility directly to 

23 wholesalers, retailers, or consumers in the United 

24 States. 


sradovich on DSK3GMQ082PROD with BILLS
156 

•S 2315 RS

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

2 monograph drug activities’ means the expenses in 

3 connection with monograph drug activities for— 

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

5 Drug Administration, contractors of the Food 

6 and Drug Administration, advisory committees, 

7 and costs related to such officers, employees, and 

8 committees and to contracts with such contrac9 tors; 

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

11 acquisition, maintenance, and repair of com12 puter resources; 

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

14 repair of facilities and acquisition, maintenance, 

15 and repair of fixtures, furniture, scientific equip16 ment, and other necessary materials and sup17 plies; and 

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

19 and accounting for resources allocated for mono20 graph drug activities. 

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

22 the unique number automatically generated by the 

23 Field Accomplishments and Compliance Tracking 

24 System of the Food and Drug Administration. 


sradovich on DSK3GMQ082PROD with BILLS
157 

•S 2315 RS

1 ‘‘(5) The term ‘monograph drug’ means a drug 

2 subject to section 505G. 

3 ‘‘(6) The term ‘monograph drug activities’ means 

4 activities of the Secretary associated with monograph 

5 drugs and inspection of facilities associated with such 

6 drugs, including— 

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

8 evaluation of monograph drugs and monograph 

9 drug order requests, including— 

10 ‘‘(i) orders proposing or finalizing ap11 plicable requirements for monograph drugs; 

12 ‘‘(ii) orders affecting status regarding 

13 general recognition of safety and effective14 ness of a monograph drug ingredient or 

15 combination of ingredients under specified 

16 requirements; 

17 ‘‘(iii) all monograph drug development 

18 and review activities, including intra-agen19 cy collaboration; 

20 ‘‘(iv) regulation and policy develop21 ment activities related to monograph drugs; 

22 ‘‘(v) development of product standards 

23 for drugs subject to review and evaluation; 

24 ‘‘(vi) meetings regarding monograph 

25 drug activities; 


sradovich on DSK3GMQ082PROD with BILLS
158 

•S 2315 RS

1 ‘‘(vii) review of labeling prior to 

2 issuance of orders related to monograph 

3 drugs or conditions of use; and 

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

6 ‘‘(B) inspections related to monograph 

7 drugs; 

8 ‘‘(C) monitoring of clinical and other re9 search conducted in connection with monograph 

10 drugs; 

11 ‘‘(D) safety activities with respect to mono12 graph drugs, including— 

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

15 including adverse event reports; 

16 ‘‘(ii) developing and using improved 

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

19 and 

20 ‘‘(iii) developing and using improved 

21 analytical tools to assess potential safety 

22 risks, including access to external databases; 

23 and 

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


sradovich on DSK3GMQ082PROD with BILLS
159 

•S 2315 RS

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

2 means a foreign or domestic business or other enti3 ty— 

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

5 direct or indirect; 

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

7 engaged in manufacturing or processing a mono8 graph drug in finished dosage form; 

9 ‘‘(iii) includes a finished dosage form man10 ufacturer facility or an affiliate thereof in a con11 tractual relationship with a monograph drug re12 questor or requestors to manufacture or process 

13 monograph drugs; and 

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

15 entity whose only manufacturing or processing 

16 activities relate to— 

17 ‘‘(I) production of clinical research 

18 supplies; 

19 ‘‘(II) testing; or 

20 ‘‘(III) placement of outer overpack21 aging on packages containing multiple 

22 products, for such purposes as creating 

23 multipacks, when each monograph drug 

24 product contained within the overpackaging 


sradovich on DSK3GMQ082PROD with BILLS
160 

•S 2315 RS

1 is already in a final packaged form prior to 

2 placement in the outer overpackaging. 

3 ‘‘(B) For purposes of subparagraph (A), separate 

4 buildings or locations within close proximity are con5 sidered to be at 1 geographic location or address if the 

6 activities conducted in them are— 

7 ‘‘(i) closely related to the same business en8 terprise; 

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

10 management; and 

11 ‘‘(iii) under a single firm establishment 

12 identifier and capable of being inspected by the 

13 Food and Drug Administration during a single 

14 inspection. 

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

16 definition of a facility under this paragraph but for 

17 being under multiple management, the business or 

18 other entity is deemed to constitute multiple facilities, 

19 one per management entity, for purposes of this para20 graph. 

21 ‘‘(8) The term ‘monograph drug meeting’ means 

22 any meeting regarding the content of a proposed 

23 monograph drug order request. 

24 ‘‘(9) The term ‘monograph drug product’ means 

25 a monograph drug product that is marketed without 


sradovich on DSK3GMQ082PROD with BILLS
161 

•S 2315 RS

1 an approved new drug application in accordance 

2 with section 505G. 

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

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

5 the issuance of an administrative order for a change 

6 to the monograph drug product. 

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

8 means an entity submitting a monograph drug order 

9 request or a monograph drug meeting request or any 

10 other inquiry relating to a request for an order or de11 velopment of a monograph drug order request. 

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

13 thereof. 

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

15 request’ means any monograph drug order request not 

16 determined to be a Tier 2 monograph drug order re17 quest. 

18 ‘‘(14)(A) The term ‘Tier 2 monograph drug order 

19 request’ means, subject to subparagraph (B), a mono20 graph drug order request for— 

21 ‘‘(i) the reordering of existing information 

22 in the drug facts label of a monograph drug 

23 product; 

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

25 other information section of the drug facts label 


sradovich on DSK3GMQ082PROD with BILLS
162 

•S 2315 RS

1 of a nonprescription drug product, as limited by 

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

3 Regulations; 

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

5 section of the drug facts label of a nonprescrip6 tion drug product, if such changes conform to 

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

8 ‘‘(iv) the standardization of the concentra9 tion or dose of a specific finalized ingredient 

10 within a particular finalized monograph; 

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

12 align with nomenclature of a standards-setting 

13 organization; or 

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

15 accordance with part 330.1 of title 21, Code of 

16 Federal Regulations (or any successor regula17 tion). 

18 ‘‘(B) The Secretary may, based on program im19 plementation experience or other factors found appro20 priate by the Secretary, characterize any monograph 

21 drug order request as a Tier 2 monograph drug order 

22 request (including recategorizing a request from Tier 

23 1 to Tier 2) and publish such determination in a pro24 posed order issued pursuant to section 505G(c). 


sradovich on DSK3GMQ082PROD with BILLS
163 

•S 2315 RS

1 ‘‘SEC. 744L–1. AUTHORITY TO ASSESS AND USE MONO2 GRAPH DRUG FEES. 

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

4 2019, the Secretary shall assess and collect fees in accord5 ance with this section as follows: 

6 ‘‘(1) FACILITY FEE.— 

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

8 subparagraph (B), each person that owns a facil9 ity identified as a monograph drug facility on 

10 December 31 of the fiscal year or at any time 

11 during the preceding 12-month period shall be 

12 assessed an annual fee for each such facility as 

13 determined under subsection (c). 

14 ‘‘(B) EXCEPTION.— 

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

16 assessed under subparagraph (A) if the 

17 identified monograph drug facility has 

18 ceased all activities related to monograph 

19 drugs prior to the publication of the Notice 

20 under subparagraph C and has updated its 

21 registration to reflect such change under the 

22 requirements for drug establishment reg23 istration set forth in section 510. 

24 ‘‘(ii) FEE AMOUNT.—The amount of 

25 the fee for a contract manufacturing organi26 zation facility shall be equal to two-thirds 


sradovich on DSK3GMQ082PROD with BILLS
164 

•S 2315 RS

1 the amount of the fee for a monograph drug 

2 facility that is not a contract manufac3 turing organization facility. 

4 ‘‘(C) DUE DATE.— 

5 ‘‘(i) FOR FIRST PROGRAM YEAR.—For 

6 fiscal year 2019, the facility fees required 

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

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

11 ‘‘(ii) SUBSEQUENT FISCAL YEARS.— 

12 For each fiscal year after fiscal year 2019, 

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

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

16 of such year; or 

17 ‘‘(II) the first business day after 

18 the date of enactment of an appropria19 tions Act providing for the collection 

20 and obligation of fees under this sec21 tion for such year. 

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

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

25 subject to a fee for a monograph drug order reVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00164 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
165 

•S 2315 RS

1 quest. The monograph drug order request fee 

2 under paragraph (2) shall be— 

3 ‘‘(i) for a Tier 1 monograph drug 

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

6 subsection (c)(1)); and 

7 ‘‘(ii) for a Tier 2 monograph drug 

8 order request other than a Tier 1 request, 

9 $100,000 adjusted for inflation for the fiscal 

10 year (as determined under subsection 

11 (c)(1)). 

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

13 order request fees required under subparagraph 

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

15 monograph drug order request. 

16 ‘‘(C) EXCEPTION FOR CERTAIN SAFETY

17 CHANGES.—A person who is named as the re18 questor in a monograph drug order shall not be 

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

20 Secretary finds that the monograph drug order 

21 request seeks to change the Drug Facts labeling 

22 of a monograph drug product in a way that 

23 would add to or strengthen— 

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

25 precaution; 


sradovich on DSK3GMQ082PROD with BILLS
166 

•S 2315 RS

1 ‘‘(ii) a statement about risk associated 

2 with misuse or abuse; or 

3 ‘‘(iii) an instruction about dosage and 

4 administration that is intended to increase 

5 the safe use of the monograph drug product. 

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

7 IS RECATEGORIZED AS A TIER 2 MONOGRAPH

8 DRUG ORDER REQUEST.—If the Secretary deter9 mines that a monograph drug request initially 

10 characterized as Tier 1 should be re-characterized 

11 as a Tier 2 monograph drug order request, and 

12 the requestor has paid a Tier 1 fee in accordance 

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

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

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

18 REFUSED FOR FILING OR WITHDRAWN BEFORE

19 FILING.—The Secretary shall refund 75 percent 

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

21 order request that is refused for filing. 

22 ‘‘(F) FEES FOR ORDER REQUESTS PRE23 VIOUSLY REFUSED FOR FILING OR WITHDRAWN

24 BEFORE FILING.—A monograph drug order re25 quest that was submitted but was refused for filVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00166 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
167 

•S 2315 RS

1 ing, or was withdrawn before being accepted or 

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

3 under subparagraph (A) upon being resubmitted 

4 or filed over protest. 

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

6 WITHDRAWN.—If an order request is withdrawn 

7 after the order request was filed, the Secretary 

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

9 substantial work was performed on the order re10 quest after the application was filed. The Sec11 retary shall have the sole discretion to refund a 

12 fee or a portion of the fee under this subpara13 graph. A determination by the Secretary con14 cerning a refund under this paragraph shall not 

15 be reviewable. 

16 ‘‘(3) REFUNDS.— 

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

18 under subparagraphs (D) through (G) of para19 graph (2), the Secretary shall not refund any fee 

20 paid under this subsection, except as provided in 

21 subparagraph (B). 

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

23 qualify for the return of a fee claimed to have 

24 been paid in error under this paragraph, a per25 son shall submit to the Secretary a written reVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00167 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
168 

•S 2315 RS

1 quest justifying such return within 180 calendar 

2 days after such fee was paid. 

3 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

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

6 generate a total facility fee revenue amount equal to 

7 the sum of— 

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

9 2019 (as determined under paragraph (3)); 

10 ‘‘(B) the dollar amount equal to the oper11 ating reserve adjustment for the fiscal year, if 

12 applicable (as determined under subsection 

13 (c)(2)); and 

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

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

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

17 the fiscal years 2020 through 2023, fees under sub18 section (a)(1) shall be established to generate a total 

19 facility fee revenue amount equal to the sum of— 

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

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

22 ‘‘(B) the dollar amount equal to the infla23 tion adjustment for the fiscal year (as deter24 mined under subsection (c)(1)); 


sradovich on DSK3GMQ082PROD with BILLS
169 

•S 2315 RS

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

3 applicable (as determined under subsection 

4 (c)(2)); 

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

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

7 ‘‘(E) additional dollar amounts for each fis8 cal year as follows: 

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

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

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

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

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

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

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

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

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

18 dollar amount of the total revenue amount estab19 lished under this subsection for the previous fis20 cal year, not including any adjustments made 

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

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

23 ‘‘(1) INFLATION ADJUSTMENT.— 

24 ‘‘(A) IN GENERAL.—For purposes of sub25 section (b)(2)(B), the dollar amount of the inflaVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00169 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
170 

•S 2315 RS

1 tion adjustment to the annual base revenue for 

2 fiscal year 2020 and each subsequent fiscal year 

3 shall be equal to the product of— 

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

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

6 ‘‘(ii) the inflation adjustment percent7 age under subparagraph (B). 

8 ‘‘(B) INFLATION ADJUSTMENT PERCENT9 AGE.—The inflation adjustment percentage 

10 under this subparagraph for a fiscal year is 

11 equal to— 

12 ‘‘(i) for each of fiscal years 2020 

13 through 2021, the average annual percent 

14 change that occurred in the Consumer Price 

15 Index for urban consumers (Washington16 Baltimore, DC–MD–VA–WV; Not Season17 ally Adjusted; All items; Annual Index) for 

18 the first 3 years of the preceding 4 years of 

19 available data; and 

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

21 2023, the sum of— 

22 ‘‘(I) the average annual percent 

23 change in the cost, per full-time equiv24 alent position of the Food and Drug 

25 Administration, of all personnel comVerDate Sep 11 2014 22:10 May 14, 2018 Jkt 079200 PO 00000 Frm 00170 Fmt 6652 Sfmt 6203 E:\BILLS\S2315.RS S2315

sradovich on DSK3GMQ082PROD with BILLS
171 

•S 2315 RS

1 pensation and benefits paid with re2 spect to such positions for the first 3 

3 years of the preceding 4 fiscal years, 

4 multiplied by the proportion of per5 sonnel compensation and benefits costs 

6 to total costs of monograph drug ac7 tivities (as defined in subsection (a)) 

8 for the first 3 years of the preceding 4 

9 fiscal years; and 

10 ‘‘(II) the average annual percent 

11 change that occurred in the Consumer 

12 Price Index for urban consumers 

13 (Washington-Baltimore, DC–MD–VA– 

14 WV; Not Seasonally Adjusted; All 

15 items; Annual Index) for the first 3 

16 years of the preceding 4 years of avail17 able data multiplied by the proportion 

18 of all costs other than personnel com19 pensation and benefits costs to total 

20 costs of monograph drug activities for 

21 the first 3 years of the preceding 4 fis22 cal years. 

23 ‘‘(2) OPERATING RESERVE ADJUSTMENT.— 

24 ‘‘(A) For fiscal year 2019 and subsequent 

25 fiscal years, the Secretary may, in addition to 


sradovich on DSK3GMQ082PROD with BILLS
172 

•S 2315 RS

1 adjustments under paragraphs (1) and (2), fur2 ther increase the fee revenue and fees if such an 

3 adjustment is necessary to provide operating re4 serves of carryover user fees for monograph drug 

5 activities for the number of weeks specified in 

6 subparagraph (B). 

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

8 weeks of operating reserves shall be no more 

9 than— 

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

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

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

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

14 and 

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

16 ‘‘(C) If, for fiscal years 2020 through 2023, 

17 the Secretary has carryover balances for mono18 graph drug activities in excess of the number of 

19 weeks of such operating reserves specified in sub20 paragraph B, the Secretary shall reduce such fee 

21 revenue and fees to provide for not more than the 

22 number of weeks of such operating reserves speci23 fied in subparagraph (B)(v). 

24 ‘‘(D) If an adjustment under this para25 graph is made, the rationale for the amount of 


sradovich on DSK3GMQ082PROD with BILLS
173 

•S 2315 RS

1 the increase or decrease (as applicable) in fee 

2 revenue and fees shall be contained in the annual 

3 Federal Register notice under paragraph (5) es4 tablishing fee revenue and fees for the fiscal year 

5 involved. 

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

7 The Secretary shall, in addition to adjustments under 

8 paragraphs (1) and (2), further increase the fee rev9 enue by an amount equal to— 

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

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

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

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

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

15 ‘‘(4) ANNUAL FEE SETTING.— 

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

17 shall, not later than January 31, 2019— 

18 ‘‘(i) establish monograph drug facility 

19 fees for fiscal year 2019 under subsection 

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

21 such year under subsection (b) and the ad22 justments provided under this subsection; 

23 and 

24 ‘‘(ii) publish such fee revenue and fa25 cility fees in the Federal Register. 


sradovich on DSK3GMQ082PROD with BILLS
174 

•S 2315 RS

1 ‘‘(B) SUBSEQUENT FISCAL YEARS.—The 

2 Secretary shall, not later than January 31 of 

3 each fiscal year that begins after September 30, 

4 2019, establish for each such fiscal year, based on 

5 the revenue amounts under subsection (b) and 

6 the adjustments provided under this subsection— 

7 ‘‘(i) monograph drug facility fees 

8 under subsection (a)(1); 

9 ‘‘(ii) monograph drug order request 

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

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

12 fees, and monograph drug order request fees 

13 in the Federal Register. 

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

15 that owns a monograph drug facility shall submit to the 

16 Secretary the information required under this subsection 

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

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

19 drug establishment registration set forth in section 

20 510; and 

21 ‘‘(2) include for each such facility, at a min22 imum, identification of the facility’s business oper23 ation as that of a monograph drug facility. 

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


sradovich on DSK3GMQ082PROD with BILLS
175 

•S 2315 RS

1 ‘‘(1) IN GENERAL.—A monograph drug order re2 quest submitted by a person subject to fees under sub3 section (a) shall be considered incomplete and shall 

4 not be accepted for filing by the Secretary until all 

5 fees owed by such person have been paid. 

6 ‘‘(2) EFFECT ON ELIGIBILITY FOR MEETINGS.— 

7 If a monograph drug requestor fails to pay a fee as8 sessed under subsection (a), the requestor shall be con9 sidered ineligible for monograph drug meetings. 

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

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

12 of the due date as specified in subparagraph (D) of such 

13 subsection shall result in the Secretary placing the facility 

14 on a publicly available arrears list until such fee has been 

15 paid. 

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

17 ‘‘(1) IN GENERAL.—Fees authorized under sub18 section (a) shall be collected and available for obliga19 tion only to the extent and in the amount provided 

20 in advance in appropriations Acts. Such fees are au21 thorized to remain available until expended. Such 

22 sums as may be necessary may be transferred from 

23 the Food and Drug Administration salaries and ex24 penses appropriation account without fiscal year lim25 itation to such appropriation account for salaries and 


sradovich on DSK3GMQ082PROD with BILLS
176 

•S 2315 RS

1 expenses with such fiscal year limitation. The sums 

2 transferred shall be available solely for monograph 

3 drug activities. 

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

5 ‘‘(A) IN GENERAL.—Subject to subpara6 graph (C), the fees authorized by this section 

7 shall be collected and available in each fiscal 

8 year in an amount not to exceed the amount 

9 specified in appropriation Acts, or otherwise 

10 made available for obligation, for such fiscal 

11 year. 

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

13 fees authorized by this section shall be available 

14 to defray increases in the costs of the resources 

15 allocated for monograph drug activities (includ16 ing increases in such costs for an additional 

17 number of full-time equivalent positions in the 

18 Department of Health and Human Services to be 

19 engaged in such activities), only if the Secretary 

20 allocates for such purpose an amount for such 

21 fiscal year (excluding amounts from fees col22 lecting under this section) no less than 

23 $12,000,000, multiplied by the adjustment factor 

24 applicable to the fiscal year involved. 


sradovich on DSK3GMQ082PROD with BILLS
177 

•S 2315 RS

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

2 considered to have met the requirements of sub3 paragraph (B) in any fiscal year if the costs 

4 funded by appropriations and allocated for the 

5 monograph drug activities are not more than 15 

6 percent below the level specified in such subpara7 graph. 

8 ‘‘(D) PROVISION FOR EARLY PAYMENTS IN

9 SUBSEQUENT YEARS.—Payment of fees author10 ized under this section for a fiscal year (after fis11 cal year 2019), prior to the due date for such 

12 fees, may be accepted by the Secretary in accord13 ance with authority provided in advance in a 

14 prior year appropriations Act. 

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

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

17 authorized to be appropriated for fees under this sec18 tion an amount equal to the total amount of fees as19 sessed for such fiscal year under this section. 

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

21 where the Secretary does not receive payment of a fee as22 sessed under subsection (a) within 30 calendar days after 

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

24 States Government subject to subchapter II of chapter 37 

25 of title 31. 


sradovich on DSK3GMQ082PROD with BILLS
178 

•S 2315 RS

1 ‘‘(i) CONSTRUCTION.—This section may not be con2 strued to require that the number of full-time equivalent 

3 positions in the Department of Health and Human Serv4 ices, for officers, employers, and advisory committees not 

5 engaged in monograph drug activities, be reduced to offset 

6 the number of officers, employees, and advisory committees 

7 so engaged. 

8 ‘‘SEC. 744L–2. REAUTHORIZATION; REPORTING REQUIRE9 MENTS. 

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

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

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

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

14 the Committee on the Health, Education, Labor, and Pen15 sions of the Senate and the Committee on Energy and Com16 merce of the House of Representatives a report concerning 

17 the progress of the Food and Drug Administration in 

18 achieving the goals identified in the letters described in sec19 tion 201 of the Over-the-Counter Drug Safety, Innovation, 

20 and Reform Act during such fiscal year and the future 

21 plans of the Food and Drug Administration for meeting 

22 such goals. 

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

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

25 fiscal year for which fees are collected under this part, the 


sradovich on DSK3GMQ082PROD with BILLS
179 

•S 2315 RS

1 Secretary shall prepare and submit to the Committee on 

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

3 the Committee on Energy and Commerce of the House of 

4 Representatives a report on the implementation of the au5 thority for such fees during such fiscal year and the use, 

6 by the Food and Drug Administration, of the fees collected 

7 for such fiscal year. 

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

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

10 to the public on the internet website of the Food and Drug 

11 Administration. 

12 ‘‘(d) REAUTHORIZATION.— 

13 ‘‘(1) CONSULTATION.—In developing rec14 ommendations to present to Congress with respect to 

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

16 meeting the goals, for monograph drug activities for 

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

18 the reauthorization of this part for such fiscal years, 

19 the Secretary shall consult with— 

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

21 Labor, and Pensions of the Senate; 

22 ‘‘(B) the Committee on Energy and Com23 merce of the House of Representatives; 

24 ‘‘(C) scientific and academic experts; 

25 ‘‘(D) health care professionals; 


sradovich on DSK3GMQ082PROD with BILLS
180 

•S 2315 RS

1 ‘‘(E) representatives of patient and con2 sumer advocacy groups; and 

3 ‘‘(F) the regulated industry. 

4 ‘‘(2) PUBLIC REVIEW OF RECOMMENDATIONS.— 

5 After negotiations with the regulated industry, the 

6 Secretary shall— 

7 ‘‘(A) present the recommendations developed 

8 under paragraph (1) to the congressional com9 mittees specified in such paragraph; 

10 ‘‘(B) publish such recommendations in the 

11 Federal Register; 

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

13 days for the public to provide written comments 

14 on such recommendations; 

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

16 may present its views on such recommendations; 

17 and 

18 ‘‘(E) after consideration of such public 

19 views and comments, revise such recommenda20 tions as necessary. 

21 ‘‘(3) TRANSMITTAL OF RECOMMENDATIONS.—Not 

22 later than January 15, 2023, the Secretary shall 

23 transmit to Congress the revised recommendations 

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

25 comments received under such paragraph, and any 


sradovich on DSK3GMQ082PROD with BILLS
181 

•S 2315 RS

1 changes made to the recommendations in response to 

2 such views and comments.’’. 


sradovich on DSK3GMQ082PROD with BILLS
Calendar No. 413 

115TH CONGRESS 

2D SESSION S. 2315 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

tion, and for other purposes. marketed without an approved new drug applicaspect to certain nonprescription drugs that are Act to clarify the regulatory framework with reMAY 14, 2018 

Reported with an amendment 


sradovich on DSK3GMQ082PROD with BILLS