II 

Calendar No. 76 

115TH CONGRESS 

1ST SESSION S. 934 

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

the user-fee programs for prescription drugs, medical devices, generic 

drugs, and biosimilar biological products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

APRIL 25, 2017 

Mr. ALEXANDER (for himself and Mrs. MURRAY) introduced the following bill; 

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

MAY 11, 2017 

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 

revise and extend the user-fee programs for prescription 

drugs, medical devices, generic drugs, and biosimilar biological products, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘FDA Reauthorization 

3 Act of 2017’’. 

4 SEC. 2. TABLE OF CONTENTS. 

5 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Authority to assess and use drug fees. 

Sec. 103. Reauthorization; reporting requirements. 

Sec. 104. Sunset dates. 

Sec. 105. Effective date. 

Sec. 106. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; findings. 

Sec. 202. Definitions. 

Sec. 203. Authority to assess and use device fees. 

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Conformity assessment pilot program. 

Sec. 206. Reauthorization of review. 

Sec. 207. Electronic format for submissions. 

Sec. 208. Savings clause. 

Sec. 209. Effective date. 

Sec. 210. Sunset clause. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title; finding. 

Sec. 302. Definitions. 

Sec. 303. Authority to assess and use human generic drug fees. 

Sec. 304. Reauthorization; reporting requirements. 

Sec. 305. Sunset dates. 

Sec. 306. Effective date. 

Sec. 307. Savings clause. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL 

PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Definitions. 

Sec. 403. Authority to assess and use biosimilar fees. 

Sec. 404. Reauthorization; reporting requirements. 

Sec. 405. Sunset dates. 

Sec. 406. Effective date. 

Sec. 407. Savings clause. 

TITLE V—REAUTHORIZATION OF OTHER PROGRAMS 


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Sec. 501. Reauthorization of provision relating to exclusivity of certain drugs 

containing single enantiomers. 

Sec. 502. Reauthorization of pediatric humanitarian device exceptions. 

Sec. 503. Reauthorization of the critical path public-private partnerships. 

Sec. 504. Reauthorization of pediatric device consortia. 

Sec. 505. Reauthorization of orphan grants program. 

1 TITLE I—FEES RELATING TO 

2 DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

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

5 ‘‘Prescription Drug User Fee Amendments of 2017’’. 

6 (b) FINDING.—The Congress finds that the fees au7 thorized by the amendments made in this title will be dedi8 cated toward expediting the drug development process and 

9 the process for the review of human drug applications, in10 cluding postmarket drug safety activities, as set forth in 

11 the goals identified for purposes of part 2 of subchapter 

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

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

14 Human Services to the Chairman of the Committee on 

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

16 the Chairman of the Committee on Energy and Commerce 

17 of the House of Representatives, as set forth in the Con18 gressional Record. 

19 SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 

20 (a) TYPES OF FEES.— 


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1 (1) IN GENERAL.—Section 736(a) of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

3 379h(a)) is amended— 

4 (A) in the matter preceding paragraph (1), 

5 by striking ‘‘fiscal year 2013’’ and inserting 

6 ‘‘fiscal year 2018’’; 

7 (B) in the heading of paragraph (1), by 

8 striking ‘‘AND SUPPLEMENT’’; 

9 (C) in paragraph (1), by striking ‘‘or a 

10 supplement’’ and ‘‘or supplement’’ each place 

11 either appears; 

12 (D) in paragraph (1)(A)— 

13 (i) in clause (i), by striking ‘‘(c)(4)’’ 

14 and inserting ‘‘(c)(5)’’; and 

15 (ii) in clause (ii), by striking ‘‘A fee 

16 established’’ and all that follows through 

17 ‘‘are required.’’ and inserting the following: 

18 ‘‘A fee established under subsection (c)(5) 

19 for a human drug application for which 

20 clinical data (other than bioavailability or 

21 bioequivalence studies) with respect to 

22 safety or effectiveness are not required for 

23 approval.’’; 

24 (E) in the heading of paragraph (1)(C), by 

25 striking ‘‘OR SUPPLEMENT’’; 


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1 (F) in paragraph (1)(F)— 

2 (i) in the heading, by striking ‘‘OR IN3 DICATION’’; and 

4 (ii) by striking the second sentence; 

5 (G) by striking paragraph (2) (relating to 

6 a prescription drug establishment fee); 

7 (H) by redesignating paragraph (3) as 

8 paragraph (2); 

9 (I) in the heading of paragraph (2), as so 

10 redesignated, by striking ‘‘PRESCRIPTION DRUG

11 PRODUCT FEE’’ and inserting ‘‘PRESCRIPTION

12 DRUG PROGRAM FEE’’; 

13 (J) in subparagraph (A) of such paragraph 

14 (2), by amending the first sentence to read as 

15 follows: ‘‘Except as provided in subparagraphs 

16 (B) and (C), each person who is named as the 

17 applicant in a human drug application, and 

18 who, after September 1, 1992, had pending be19 fore the Secretary a human drug application or 

20 supplement, shall pay the annual prescription 

21 drug program fee established for a fiscal year 

22 under subsection (c)(5) for each prescription 

23 drug product that is identified in such a human 

24 drug application approved as of October 1 of 

25 such fiscal year.’’; 


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1 (K) in subparagraph (B) of such para2 graph (2)— 

3 (i) in the heading of subparagraph 

4 (B), by inserting after ‘‘EXCEPTION’’ the 

5 following: ‘‘FOR CERTAIN PRESCRIPTION

6 DRUG PRODUCTS’’; and 

7 (ii) by striking ‘‘A prescription drug 

8 product shall not be assessed a fee’’ and 

9 inserting ‘‘A prescription drug program fee 

10 shall not be assessed for a prescription 

11 drug product’’; and 

12 (L) by adding at the end of such para13 graph (2) the following: 

14 ‘‘(C) LIMITATION.—A person who is 

15 named as the applicant in an approved human 

16 drug application shall not be assessed more 

17 than 5 prescription drug program fees for a fis18 cal year for prescription drug products identi19 fied in such approved human drug applica20 tion.’’. 

21 (2) CONFORMING AMENDMENT.—Subparagraph 

22 (C) of section 740(a)(3) of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 379j–12(a)(3)) is 

24 amended to read as follows: 


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1 ‘‘(C) LIMITATION.—An establishment shall 

2 be assessed only one fee per fiscal year under 

3 this section.’’. 

4 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec5 tion 736 of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 379h) is amended to read as follows: 

7 ‘‘(b) FEE REVENUE AMOUNTS.— 

8 ‘‘(1) IN GENERAL.—For each of the fiscal years 

9 2018 through 2022, fees under subsection (a) shall, 

10 except as provided in subsections (c), (d), (f), and 

11 (g), be established to generate a total revenue 

12 amount under such subsection that is equal to the 

13 sum of— 

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

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

16 ‘‘(B) the dollar amount equal to the infla17 tion adjustment for the fiscal year (as deter18 mined under subsection (c)(1)); 

19 ‘‘(C) the dollar amount equal to the capac20 ity planning adjustment for the fiscal year (as 

21 determined under subsection (c)(2)); 

22 ‘‘(D) the dollar amount equal to the oper23 ating reserve adjustment for the fiscal year, if 

24 applicable (as determined under subsection 

25 (c)(3)); 


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1 ‘‘(E) the dollar amount equal to the addi2 tional direct cost adjustment for the fiscal year 

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

4 ‘‘(F) additional dollar amounts for each 

5 fiscal year as follows: 

6 ‘‘(i) $20,077,793 for fiscal year 2018; 

7 ‘‘(ii) $21,317,472 for fiscal year 2019; 

8 ‘‘(iii) $16,953,329 for fiscal year 

9 2020; 

10 ‘‘(iv) $5,426,896 for fiscal year 2021; 

11 and 

12 ‘‘(v) $2,769,609 for fiscal year 2022. 

13 ‘‘(2) TYPES OF FEES.—Of the total revenue 

14 amount determined for a fiscal year under para15 graph (1)— 

16 ‘‘(A) 20 percent shall be derived from 

17 human drug application fees under subsection 

18 (a)(1); and 

19 ‘‘(B) 80 percent shall be derived from pre20 scription drug program fees under subsection 

21 (a)(2). 

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

23 of paragraph (1), the dollar amount of the annual 

24 base revenue for a fiscal year shall be— 


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1 ‘‘(A) for fiscal year 2018, $878,590,000; 

2 and 

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

4 the dollar amount of the total revenue amount 

5 established under paragraph (1) for the pre6 vious fiscal year, not including any adjustments 

7 made under subsection (c)(3) or (c)(4).’’. 

8 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Sub9 section (c) of section 736 of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 379h) is amended to read as fol11 lows: 

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

13 ‘‘(1) INFLATION ADJUSTMENT.— 

14 ‘‘(A) IN GENERAL.—For purposes of sub15 section (b)(1)(B), the dollar amount of the in16 flation adjustment to the annual base revenue 

17 for each fiscal year shall be equal to the prod18 uct of— 

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

20 fiscal year under subsection (b)(1)(A); and 

21 ‘‘(ii) the inflation adjustment percent22 age under subparagraph (B). 

23 ‘‘(B) INFLATION ADJUSTMENT PERCENT24 AGE.—The inflation adjustment percentage 


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1 under this subparagraph for a fiscal year is 

2 equal to the sum of— 

3 ‘‘(i) the average annual percent 

4 change in the cost, per full-time equivalent 

5 position of the Food and Drug Administra6 tion, of all personnel compensation and 

7 benefits paid with respect to such positions 

8 for the first 3 years of the preceding 4 fis9 cal years, multiplied by the proportion of 

10 personnel compensation and benefits costs 

11 to total costs of the process for the review 

12 of human drug applications (as defined in 

13 section 735(6)) for the first 3 years of the 

14 preceding 4 fiscal years; and 

15 ‘‘(ii) 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 multiplied 

22 by the proportion of all costs other than 

23 personnel compensation and benefits costs 

24 to total costs of the process for the review 

25 of human drug applications (as defined in 


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1 section 735(6)) for the first 3 years of the 

2 preceding 4 fiscal years. 

3 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

4 ‘‘(A) IN GENERAL.—For each fiscal year, 

5 after the annual base revenue established in 

6 subsection (b)(1)(A) is adjusted for inflation in 

7 accordance with paragraph (1), such revenue 

8 shall be adjusted further for such fiscal year, in 

9 accordance with this paragraph, to reflect 

10 changes in the resource capacity needs of the 

11 Secretary for the process for the review of 

12 human drug applications. 

13 ‘‘(B) INTERIM METHODOLOGY.— 

14 ‘‘(i) IN GENERAL.—Until the capacity 

15 planning methodology described in sub16 paragraph (C) is effective, the adjustment 

17 under this paragraph for a fiscal year shall 

18 be based on the product of— 

19 ‘‘(I) the annual base revenue for 

20 such year, as adjusted for inflation 

21 under paragraph (1); and 

22 ‘‘(II) the adjustment percentage 

23 under clause (ii). 

24 ‘‘(ii) ADJUSTMENT PERCENTAGE.— 

25 The adjustment percentage under this 


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1 clause for a fiscal year is the weighted 

2 change in the 3-year average ending in the 

3 most recent year for which data are avail4 able, over the 3-year average ending in the 

5 previous year, for— 

6 ‘‘(I) the total number of human 

7 drug applications, efficacy supple8 ments, and manufacturing supple9 ments submitted to the Secretary; 

10 ‘‘(II) the total number of active 

11 commercial investigational new drug 

12 applications; and 

13 ‘‘(III) the total number of formal 

14 meetings scheduled by the Secretary, 

15 and written responses issued by the 

16 Secretary in lieu of such formal meet17 ings, as identified in section I.H of 

18 the letters described in section 101(b) 

19 of the Prescription Drug User Fee 

20 Amendments of 2017. 

21 ‘‘(C) CAPACITY PLANNING METHOD22 OLOGY.— 

23 ‘‘(i) DEVELOPMENT; EVALUATION

24 AND REPORT.—The Secretary shall obtain, 

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1 counting or consulting firm, a report evalu2 ating options and recommendations for a 

3 new methodology to accurately assess 

4 changes in the resource and capacity needs 

5 of the process for the review of human 

6 drug applications. The capacity planning 

7 methodological options and recommenda8 tions presented in such report shall utilize 

9 and be informed by personnel time report10 ing data as an input. The report shall be 

11 published for public comment no later than 

12 the end of fiscal year 2020. 

13 ‘‘(ii) ESTABLISHMENT AND IMPLE14 MENTATION.—After review of the report 

15 described in clause (i) and any public com16 ments thereon, the Secretary shall estab17 lish a capacity planning methodology for 

18 purposes of this paragraph, which shall— 

19 ‘‘(I) replace the interim method20 ology under subparagraph (B); 

21 ‘‘(II) incorporate such ap22 proaches and attributes as the Sec23 retary determines appropriate; and 

24 ‘‘(III) be effective beginning with 

25 the first fiscal year for which fees are 


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1 set after such capacity planning meth2 odology is established. 

3 ‘‘(D) LIMITATION.—Under no cir4 cumstances shall an adjustment under this 

5 paragraph result in fee revenue for a fiscal year 

6 that is less than the sum of the amounts under 

7 subsections (b)(1)(A) (the annual base revenue 

8 for the fiscal year) and (b)(1)(B) (the dollar 

9 amount of the inflation adjustment for the fis10 cal year). 

11 ‘‘(E) PUBLICATION IN FEDERAL REG12 ISTER.—The Secretary shall publish in the Fed13 eral Register notice under paragraph (5) the fee 

14 revenue and fees resulting from the adjustment 

15 and the methodologies under this paragraph. 

16 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

17 ‘‘(A) INCREASE.—For fiscal year 2018 and 

18 subsequent fiscal years, the Secretary may, in 

19 addition to adjustments under paragraphs (1) 

20 and (2), further increase the fee revenue and 

21 fees if such an adjustment is necessary to pro22 vide for not more than 14 weeks of operating 

23 reserves of carryover user fees for the process 

24 for the review of human drug applications. 


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1 ‘‘(B) DECREASE.—If the Secretary has 

2 carryover balances for such process in excess of 

3 14 weeks of such operating reserves, the Sec4 retary shall decrease such fee revenue and fees 

5 to provide for not more than 14 weeks of such 

6 operating reserves. 

7 ‘‘(C) NOTICE OF RATIONALE.—If an ad8 justment under subparagraph (A) or (B) is 

9 made, the rationale for the amount of the in10 crease or decrease (as applicable) in fee revenue 

11 and fees shall be contained in the annual Fed12 eral Register notice under paragraph (5) estab13 lishing fee revenue and fees for the fiscal year 

14 involved. 

15 ‘‘(4) ADDITIONAL DIRECT COST ADJUST16 MENT.— 

17 ‘‘(A) IN GENERAL.—The Secretary shall, 

18 in addition to adjustments under paragraphs 

19 (1), (2), and (3), further increase the fee rev20 enue and fees— 

21 ‘‘(i) for fiscal year 2018, by 

22 $8,730,000; and 

23 ‘‘(ii) for fiscal year 2019 and subse24 quent fiscal years, by the amount deter25 mined under subparagraph (B). 


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1 ‘‘(B) AMOUNT.—The amount determined 

2 under this subparagraph is— 

3 ‘‘(i) $8,730,000, multiplied by 

4 ‘‘(ii) the Consumer Price Index for 

5 urban consumers (Washington-Baltimore, 

6 DC–MD–VA–WV; Not Seasonally Ad7 justed; All Items; Annual Index) for the 

8 most recent year of available data, divided 

9 by such Index for 2016. 

10 ‘‘(5) ANNUAL FEE SETTING.—The Secretary 

11 shall, not later than 60 days before the start of each 

12 fiscal year that begins after September 30, 2017— 

13 ‘‘(A) establish, for the next fiscal year, 

14 human drug application fees and prescription 

15 drug program fees under subsection (a), based 

16 on the revenue amounts established under sub17 section (b) and the adjustments provided under 

18 this subsection; and 

19 ‘‘(B) publish such fee revenue and fees in 

20 the Federal Register. 

21 ‘‘(6) LIMIT.—The total amount of fees charged, 

22 as adjusted under this subsection, for a fiscal year 

23 may not exceed the total costs for such fiscal year 

24 for the resources allocated for the process for the re25 view of human drug applications.’’. 


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1 (d) FEE WAIVER OR REDUCTION.—Section 736(d) of 

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

3 379h(d)) is amended— 

4 (1) in paragraph (1)— 

5 (A) by inserting ‘‘or’’ at the end of sub6 paragraph (B); 

7 (B) by striking subparagraph (C); and 

8 (C) by redesignating subparagraph (D) as 

9 subparagraph (C); 

10 (2) by striking paragraph (3) (relating to use of 

11 standard costs); 

12 (3) by redesignating paragraph (4) as para13 graph (3); and 

14 (4) in paragraph (3), as so redesignated— 

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

16 striking ‘‘paragraph (1)(D)’’ and inserting 

17 ‘‘paragraph (1)(C)’’; and 

18 (B) in subparagraph (B)— 

19 (i) by striking clause (ii); 

20 (ii) by striking ‘‘shall pay’’ through 

21 ‘‘(i) application fees’’ and inserting ‘‘shall 

22 pay application fees’’; and 

23 (iii) by striking ‘‘; and’’ at the end 

24 and inserting a period. 


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1 (e) EFFECT OF FAILURE TO PAY FEES.—Section 

2 736(e) of the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379h(e)) is amended by striking ‘‘all fees’’ and in4 serting ‘‘all such fees’’. 

5 (f) LIMITATIONS.—Section 736(f)(2) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is 

7 amended by striking ‘‘supplements, prescription drug es8 tablishments, and prescription drug products’’ and insert9 ing ‘‘prescription drug program fees’’. 

10 (g) CREDITING AND AVAILABILITY OF FEES.—Sec11 tion 736(g) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 379h(g)) is amended— 

13 (1) in paragraph (3)— 

14 (A) by striking ‘‘2013 through 2017’’ and 

15 inserting ‘‘2018 through 2022’’; and 

16 (B) by striking ‘‘and paragraph (4) of this 

17 subsection’’; and 

18 (2) by striking paragraph (4). 

19 (h) ORPHAN DRUGS.—Section 736(k) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is 

21 amended by striking ‘‘product and establishment fees’’ 

22 each place it appears and inserting ‘‘prescription drug pro23 gram fees’’. 


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1 SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 

2 Section 736B of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379h–2) is amended— 

4 (1) in subsection (a)(1)— 

5 (A) in the matter before subparagraph (A), 

6 by striking ‘‘2013’’ and inserting ‘‘2018’’; and 

7 (B) in subparagraph (A), by striking ‘‘Pre8 scription Drug User Fee Amendments of 2012’’ 

9 and inserting ‘‘Prescription Drug User Fee 

10 Amendments of 2017’’; 

11 (2) in subsection (b), by striking ‘‘2013’’ and 

12 inserting ‘‘2018’’; and 

13 (3) in subsection (d), by striking ‘‘2017’’ each 

14 place it appears and inserting ‘‘2022’’. 

15 SEC. 104. SUNSET DATES. 

16 (a) AUTHORIZATION.—Sections 735 and 736 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 

18 379h) shall cease to be effective October 1, 2022. 

19 (b) REPORTING REQUIREMENTS.—Section 736B of 

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

21 379h–2) shall cease to be effective January 31, 2023. 

22 (c) PREVIOUS SUNSET PROVISION.—Effective Octo23 ber 1, 2017, subsections (a) and (b) of section 105 of the 

24 Food and Drug Administration Safety and Innovation Act 

25 (Public Law 112–144) are repealed. 


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1 SEC. 105. EFFECTIVE DATE. 

2 The amendments made by this title shall take effect 

3 on October 1, 2017, or the date of the enactment of this 

4 Act, whichever is later, except that fees under part 2 of 

5 subchapter C of chapter VII of the Federal Food, Drug, 

6 and Cosmetic Act shall be assessed for all human drug 

7 applications received on or after October 1, 2017, regard8 less of the date of the enactment of this Act. 

9 SEC. 106. SAVINGS CLAUSE. 

10 Notwithstanding the amendments made by this title, 

11 part 2 of subchapter C of chapter VII of the Federal Food, 

12 Drug, and Cosmetic Act, as in effect on the day before 

13 the date of the enactment of this title, shall continue to 

14 be in effect with respect to human drug applications and 

15 supplements (as defined in such part as of such day) that 

16 on or after October 1, 2012, but before October 1, 2017, 

17 were accepted by the Food and Drug Administration for 

18 filing with respect to assessing and collecting any fee re19 quired by such part for a fiscal year prior to fiscal year 

20 2018. 

21 TITLE II—FEES RELATING TO 

22 DEVICES 

23 SEC. 201. SHORT TITLE; FINDINGS. 

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

25 ‘‘Medical Device User Fee Amendments of 2017’’. 


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1 (b) FINDINGS.—The Congress finds that the fees au2 thorized under the amendments made by this title will be 

3 dedicated toward expediting the process for the review of 

4 device applications and for assuring the safety and effec5 tiveness of devices, as set forth in the goals identified for 

6 purposes of part 3 of subchapter C of chapter VII of the 

7 Federal Food, Drug, and Cosmetic Act in the letters from 

8 the Secretary of Health and Human Services to the Chair9 man of the Committee on Health, Education, Labor, and 

10 Pensions of the Senate and the Chairman of the Com11 mittee on Energy and Commerce of the House of Rep12 resentatives, as set forth in the Congressional Record. 

13 SEC. 202. DEFINITIONS. 

14 Section 737 of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 379i) is amended— 

16 (1) by redesignating paragraphs (8) through 

17 (13) as paragraphs (9) through (14), respectively; 

18 (2) by inserting after paragraph (7) the fol19 lowing new paragraph: 

20 ‘‘(8) The term ‘de novo classification request’ 

21 means a request made under section 513(f)(2)(A) 

22 with respect to the classification of a device.’’; 

23 (3) in subparagraph (D) of paragraph (10) (as 

24 redesignated by paragraph (1)), by striking ‘‘and 


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1 submissions’’ and inserting ‘‘submissions, and de 

2 novo classification requests’’; and 

3 (4) in paragraph (11) (as redesignated by para4 graph (1)), by striking ‘‘2011’’ and inserting 

5 ‘‘2016’’. 

6 SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

7 (a) TYPES OF FEES.—Section 738(a) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 

9 amended— 

10 (1) in paragraph (1), by striking ‘‘fiscal year 

11 2013’’ and inserting ‘‘fiscal year 2018’’; and 

12 (2) in paragraph (2)— 

13 (A) in subparagraph (A)— 

14 (i) in the matter preceding clause (i), 

15 by striking ‘‘October 1, 2012’’ and insert16 ing ‘‘October 1, 2017’’; 

17 (ii) in clause (viii), by striking ‘‘2’’ 

18 and inserting ‘‘3.4’’; and 

19 (iii) by adding at the end the fol20 lowing new clause: 

21 ‘‘(xi) For a de novo classification re22 quest, a fee equal to 30 percent of the fee 

23 that applies under clause (i).’’; and 

24 (B) in subparagraph (B)(v)(I), by striking 

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1 serting ‘‘premarket notification submission, or 

2 de novo classification request’’. 

3 (b) FEE AMOUNTS.—Section 738(b) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is 

5 amended to read as follows: 

6 ‘‘(b) FEE AMOUNTS.— 

7 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

8 (d), (e), and (h), for each of fiscal years 2018 

9 through 2022, fees under subsection (a) shall be de10 rived from the base fee amounts specified in para11 graph (2), to generate the total revenue amounts 

12 specified in paragraph (3). 

13 ‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For 

14 purposes of paragraph (1), the base fee amounts 

15 specified in this paragraph are as follows: 

‘‘Fee Type 

Fiscal 

Year 

2018 

Fiscal 

Year 

2019 

Fiscal 

Year 

2020 

Fiscal 

Year 

2021 

Fiscal 

Year 

2022 

Premarket Application ........................ $294,000 $300,000 $310,000 $328,000 $329,000 

Establishment Registration ................ $4,375 $4,548 $4,760 $4,975 $4,978 

16 ‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— 

17 For purposes of paragraph (1), the total revenue 

18 amounts specified in this paragraph are as follows: 

19 ‘‘(A) $183,280,756 for fiscal year 2018. 

20 ‘‘(B) $190,654,875 for fiscal year 2019. 

21 ‘‘(C) $200,132,014 for fiscal year 2020. 

22 ‘‘(D) $211,748,789 for fiscal year 2021. 

23 ‘‘(E) $213,687,660 for fiscal year 2022.’’. 


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1 (c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 

2 738(c) of the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379j(c)) is amended— 

4 (1) in paragraph (1), by striking ‘‘2012’’ and 

5 inserting ‘‘2017’’; 

6 (2) in paragraph (2)— 

7 (A) in subparagraph (A), by striking 

8 ‘‘2014’’ and inserting ‘‘2018’’; 

9 (B) by striking subparagraph (B) and in10 serting the following new subparagraph: 

11 ‘‘(B) APPLICABLE INFLATION ADJUST12 MENT.—The applicable inflation adjustment for 

13 fiscal year 2018 and each subsequent fiscal 

14 year is the product of— 

15 ‘‘(i) the base inflation adjustment 

16 under subparagraph (C) for such fiscal 

17 year; and 

18 ‘‘(ii) the product of the base inflation 

19 adjustment under subparagraph (C) for 

20 each of the fiscal years preceding such fis21 cal year, beginning with fiscal year 2016.’’; 

22 (C) in subparagraph (C), in the heading, 

23 by striking ‘‘TO TOTAL REVENUE AMOUNTS’’; 

24 and 


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1 (D) by amending subparagraph (D) to 

2 read as follows: 

3 ‘‘(D) ADJUSTMENT TO BASE FEE

4 AMOUNTS.—For each of fiscal years 2018 

5 through 2022, the Secretary shall— 

6 ‘‘(i) adjust the base fee amounts spec7 ified in subsection (b)(2) for such fiscal 

8 year by multiplying such amounts by the 

9 applicable inflation adjustment under sub10 paragraph (B) for such year; and 

11 ‘‘(ii) if the Secretary determines nec12 essary, increase (in addition to the adjust13 ment under clause (i)) such base fee 

14 amounts, on a uniform proportionate basis, 

15 to generate the total revenue amounts 

16 under subsection (b)(3), as adjusted for in17 flation under subparagraph (A).’’; and 

18 (3) in paragraph (3)— 

19 (A) by striking ‘‘2014 through 2017’’ and 

20 inserting ‘‘2018 through 2022’’; and 

21 (B) by striking ‘‘further adjusted’’ and in22 serting ‘‘increased’’. 

23 (d) SMALL BUSINESSES; FEE WAIVER AND FEE RE24 DUCTION REGARDING PREMARKET APPROVAL FEES.— 


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1 Section 738(d) of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 379j(d)) is amended— 

3 (1) in paragraph (1), by striking ‘‘specified in 

4 clauses (i) through (v) and clauses (vii), (ix), and 

5 (x)’’ and inserting ‘‘specified in clauses (i) through 

6 (vii) and clauses (ix), (x), and (xi)’’; and 

7 (2) in paragraph (2)(C)— 

8 (A) by striking ‘‘supplement, or’’ and in9 serting ‘‘supplement,’’; and 

10 (B) by inserting ‘‘, or a de novo classifica11 tion request’’ after ‘‘class III device’’. 

12 (e) SMALL BUSINESSES; FEE REDUCTION REGARD13 ING PREMARKET NOTIFICATION SUBMISSIONS.—Section 

14 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking 

16 ‘‘50’’ and inserting ‘‘25’’. 

17 (f) FEE WAIVER OR REDUCTION.— 

18 (1) REPEAL.—Section 738 of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 379j) is amend20 ed by striking subsection (f). 

21 (2) CONFORMING CHANGES.— 

22 (A) Section 515(c)(4)(A) of the Federal 

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

24 360e(c)(4)(A)) is amended by striking ‘‘738(h)’’ 

25 and inserting ‘‘738(g)’’. 


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1 (B) Section 738 of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 379j), as 

3 amended by paragraph (1), is further amend4 ed— 

5 (i) by redesignating subsections (g) 

6 through (l) as subsections (f) through (k); 

7 (ii) in subsection (a)(2)(A), by strik8 ing ‘‘(d), (e), and (f)’’ and inserting ‘‘(d) 

9 and (e)’’; and 

10 (iii) in subsection (a)(3)(A), by strik11 ing ‘‘and subsection (f)’’. 

12 (g) EFFECT OF FAILURE TO PAY FEES.—Subsection 

13 (f)(1), as redesignated, of section 738 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend15 ed— 

16 (1) by striking ‘‘or periodic reporting con17 cerning a class III device’’ and inserting ‘‘periodic 

18 reporting concerning a class III device, or de novo 

19 classification request’’; and 

20 (2) by striking ‘‘all fees’’ and inserting ‘‘all 

21 such fees’’. 

22 (h) CONDITIONS.—Subsection (g)(1)(A), as redesig23 nated, of section 738 of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 379j) is amended by striking 

25 ‘‘$280,587,000’’ and inserting ‘‘$320,825,000’’. 


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1 (i) CREDITING AND AVAILABILITY OF FEES.—Sub2 section (h), as redesignated, of section 738 of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend4 ed— 

5 (1) in paragraph (3)— 

6 (A) by striking ‘‘2013 through 2017’’ and 

7 inserting ‘‘2018 through 2022’’; and 

8 (B) by striking ‘‘subsection (c)’’ and all 

9 that follows through the period at the end and 

10 inserting ‘‘subsection (c).’’; and 

11 (2) by striking paragraph (4). 

12 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

13 (a) PERFORMANCE REPORTS.—Section 738A(a) of 

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

15 379j–1(a)) is amended— 

16 (1) in paragraph (1)— 

17 (A) in subparagraph (A)— 

18 (i) by striking ‘‘2013’’ and inserting 

19 ‘‘2018’’; and 

20 (ii) by striking ‘‘the Medical Device 

21 User Fee Amendments of 2012’’ and in22 serting ‘‘Medical Device User Fee Amend23 ments of 2017’’; and 

24 (B) in subparagraph (B), by striking ‘‘the 

25 Medical Device User Fee Amendments of 


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1 2012’’ and inserting ‘‘Medical Device User Fee 

2 Amendments of 2017’’; and 

3 (2) in paragraph (2), by striking ‘‘2013 

4 through 2017’’ and inserting ‘‘2018 through 2022’’. 

5 (b) REAUTHORIZATION.—Section 738A(b) of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

7 1(b)) is amended— 

8 (1) in paragraph (1), by striking ‘‘2017’’ and 

9 inserting ‘‘2022’’; and 

10 (2) in paragraph (5), by striking ‘‘2017’’ and 

11 inserting ‘‘2022’’. 

12 SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 

13 (a) IN GENERAL.—Section 514 of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360d) is amended by 

15 adding at the end the following: 

16 ‘‘(d) PILOT ACCREDITATION SCHEME FOR CON17 FORMITY ASSESSMENT.— 

18 ‘‘(1) IN GENERAL.—The Secretary shall estab19 lish a pilot program under which— 

20 ‘‘(A) testing laboratories may be accred21 ited, by accreditation bodies meeting criteria 

22 specified by the Secretary, to assess the con23 formance of a device with certain standards rec24 ognized under this section; and 


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1 ‘‘(B) subject to paragraph (2), determina2 tions by testing laboratories so accredited that 

3 a device conforms with such standard or stand4 ards shall be accepted by the Secretary for pur5 poses of demonstrating such conformity under 

6 this section unless the Secretary finds that a 

7 particular such determination shall not be so 

8 accepted. 

9 ‘‘(2) SECRETARIAL REVIEW OF ACCREDITED

10 LABORATORY DETERMINATIONS.—The Secretary 

11 may— 

12 ‘‘(A) review determinations by testing lab13 oratories accredited pursuant to this subsection, 

14 including by conducting periodic audits of such 

15 determinations or processes of accredited bodies 

16 or testing laboratories and, following such re17 view, taking additional measures under this 

18 Act, such as suspension or withdrawal of ac19 creditation of such testing laboratory under 

20 paragraph (1)(A) or requesting additional infor21 mation with respect to such device, as the Sec22 retary determines appropriate; and 

23 ‘‘(B) if the Secretary becomes aware of in24 formation materially bearing on safety or effec25 tiveness of a device assessed for conformity by 


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1 a testing laboratory so accredited, take such ad2 ditional measures under this Act as the Sec3 retary determines appropriate, such as suspen4 sion or withdrawal of accreditation of such test5 ing laboratory under paragraph (1)(A), or re6 questing additional information with regard to 

7 such device. 

8 ‘‘(3) IMPLEMENTATION AND REPORTING.— 

9 ‘‘(A) PUBLIC MEETING.—The Secretary 

10 shall publish in the Federal Register a notice of 

11 a public meeting to be held no later than Sep12 tember 30, 2018, to discuss and obtain input 

13 and recommendations from stakeholders regard14 ing the goals and scope of, and a suitable 

15 framework and procedures and requirements 

16 for, the pilot program under this subsection. 

17 ‘‘(B) PILOT PROGRAM GUIDANCE.—The 

18 Secretary shall— 

19 ‘‘(i) not later than September 30, 

20 2019, issue draft guidance regarding the 

21 goals and implementation of the pilot pro22 gram under this subsection; and 

23 ‘‘(ii) not later than September 30, 

24 2021, issue final guidance with respect to 

25 the implementation of such program. 


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1 ‘‘(C) PILOT PROGRAM INITIATION.—Not 

2 later than September 30, 2020, the Secretary 

3 shall initiate the pilot program under this sub4 section. 

5 ‘‘(D) REPORT.—The Secretary shall make 

6 available on the website of the Food and Drug 

7 Administration an annual report on the 

8 progress of the pilot program under this sub9 section. 

10 ‘‘(4) SUNSET.—As of October 1, 2022— 

11 ‘‘(A) the authority for accreditation bodies 

12 to accredit testing laboratories pursuant to 

13 paragraph (1)(A) shall cease to have force or 

14 effect; 

15 ‘‘(B) the Secretary— 

16 ‘‘(i) may not accept a determination 

17 pursuant to paragraph (1)(B) made by a 

18 testing laboratory after such date; and 

19 ‘‘(ii) may accept such a determination 

20 made prior to such date; 

21 ‘‘(C) except for purposes of accepting a de22 termination described in subparagraph (B)(ii), 

23 the Secretary shall not continue to recognize 

24 the accreditation of testing laboratories accred25 ited under paragraph (1)(A); and 


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1 ‘‘(D) the Secretary may take actions in ac2 cordance with paragraph (2) with respect to the 

3 determinations made prior to such date and 

4 recognition of the accreditation of testing lab5 oratories pursuant to determinations made 

6 prior to such date.’’. 

7 SEC. 206. REAUTHORIZATION OF REVIEW. 

8 Section 523 of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 360m) is amended— 

10 (1) in subsection (a)(3)— 

11 (A) in subparagraph (A), by striking 

12 clauses (ii) and (iii) and inserting the following: 

13 ‘‘(ii) a device classified under section 

14 513(f)(2) or designated under section 

15 515C(d); or 

16 ‘‘(iii) a device that is of a type, or 

17 subset of a type, listed as not eligible for 

18 review under subparagraph (B)(iii).’’; 

19 (B) by striking subparagraph (B) and in20 serting the following: 

21 ‘‘(B) DESIGNATION FOR REVIEW.—The 

22 Secretary shall— 

23 ‘‘(i) issue draft guidance on the fac24 tors the Secretary will use in determining 

25 whether a class I or class II device type, or 


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1 subset of such device types, is eligible for 

2 review by an accredited person, includ3 ing— 

4 ‘‘(I) the risk of the device type, 

5 or subset of such device type; and 

6 ‘‘(II) whether the device type, or 

7 subset of such device type, is perma8 nently implantable, life sustaining, or 

9 life supporting; 

10 ‘‘(ii) not later than 24 months after 

11 the date on which the Secretary issues 

12 such draft guidance, finalize such guid13 ance; and 

14 ‘‘(iii) beginning on the date such guid15 ance is finalized, designate and post on the 

16 Internet website of the Food and Drug Ad17 ministration, an updated list of class I and 

18 class II device types, or subsets of such de19 vice types, and the Secretary’s determina20 tion with respect to whether each such de21 vice type, or subset of a device type, is eli22 gible or not eligible for review by an ac23 credited person under this section based on 

24 the factors described in clause (i).’’; and 

25 (C) by adding at the end the following: 


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1 ‘‘(C) INTERIM RULE.—Until the date on 

2 which the updated list is designated and posted 

3 in accordance with subparagraph (B)(iii), the 

4 list in effect on the date of enactment the Med5 ical Device User Fee Amendments of 2017 shall 

6 be in effect.’’; 

7 (2) in subsection (b)— 

8 (A) in paragraph (2)— 

9 (i) by striking subparagraph (D); and 

10 (ii) by redesignating subparagraph 

11 (E) as subparagraph (D); and 

12 (B) in paragraph (3)— 

13 (i) by redesignating subparagraph (E) 

14 as subparagraph (F); 

15 (ii) in subparagraph (F) (as so redes16 ignated), by striking ‘‘The operations of’’ 

17 and all that follows through ‘‘it will—’’ 

18 and inserting ‘‘Such person shall agree, at 

19 a minimum, to include in its request for 

20 accreditation a commitment to, at the time 

21 of accreditation, and at any time it is per22 forming any review pursuant to this sec23 tion—’’; and 

24 (iii) by inserting after subparagraph 

25 (D) the following new subparagraph: 


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1 ‘‘(E) The operations of such person shall 

2 be in accordance with generally accepted profes3 sional and ethical business practices.’’; and 

4 (3) in subsection (c), by striking ‘‘2017’’ and 

5 inserting ‘‘2022’’. 

6 SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 

7 Section 745A(b) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 379k–1(b)) is amended by adding 

9 at the end the following new paragraph: 

10 ‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLE11 LY IN ELECTRONIC FORMAT.— 

12 ‘‘(A) IN GENERAL.—Beginning on October 

13 1, 2021 (or such later date as may be specified 

14 by the Secretary under subparagraph (B)), 

15 presubmissions and submissions for devices de16 scribed in paragraph (1) (and any appeals of 

17 action taken by the Secretary with respect to 

18 such presubmissions or submissions) shall be 

19 submitted solely in such electronic format as 

20 specified by the Secretary in guidance issued 

21 under subparagraph (C). 

22 ‘‘(B) EXTENSION.—The Secretary may, if 

23 the Secretary determines an extension of the 

24 date specified in subparagraph (A) is necessary 

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1 tronic format referred to in such paragraph, ex2 tend such date until such later date as the Sec3 retary may specify, but in no event later than 

4 April 1, 2023. 

5 ‘‘(C) GUIDANCE.—The Secretary shall, not 

6 later than January 1, 2021, or such later date 

7 as may be specified by the Secretary under sub8 paragraph (B), issue guidance providing for— 

9 ‘‘(i) any further standards for the 

10 submission by electronic format required 

11 under subparagraph (A); 

12 ‘‘(ii) a timetable for the establishment 

13 by the Secretary of such further standards; 

14 and 

15 ‘‘(iii) set forth criteria for waivers of 

16 and exemptions from the requirements of 

17 this subsection.’’. 

18 SEC. 208. SAVINGS CLAUSE. 

19 Notwithstanding the amendments made by this title, 

20 part 3 of subchapter C of chapter VII of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in 

22 effect on the day before the date of the enactment of this 

23 title, shall continue to be in effect with respect to the sub24 missions listed in section 738(a)(2)(A) of such Act (as de25 fined in such part as of such day) that on or after October 


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1 1, 2012, but before October 1, 2017, were accepted by 

2 the Food and Drug Administration for filing with respect 

3 to assessing and collecting any fee required by such part 

4 for a fiscal year prior to fiscal year 2018. 

5 SEC. 209. EFFECTIVE DATE. 

6 The amendments made by this title shall take effect 

7 on October 1, 2017, or the date of the enactment of this 

8 Act, whichever is later, except that fees under part 3 of 

9 subchapter C of chapter VII of the Federal Food, Drug, 

10 and Cosmetic Act shall be assessed for all submissions list11 ed in section 738(a)(2)(A) of such Act received on or after 

12 October 1, 2017, regardless of the date of the enactment 

13 of this Act. 

14 SEC. 210. SUNSET CLAUSE. 

15 (a) AUTHORIZATION.—Sections 737 and 738 of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 

17 739j) shall cease to be effective October 1, 2022. 

18 (b) REPORTING REQUIREMENTS.—Section 738A (21 

19 U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic 

20 Act (regarding reauthorization and reporting require21 ments) shall cease to be effective January 31, 2023. 

22 (c) PREVIOUS SUNSET PROVISION.— 

23 (1) IN GENERAL.—Effective October 1, 2017, 

24 section 207(a) of the Medical Device User Fee 


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1 Amendments of 2012 (Public Law 112–144) is re2 pealed. 

3 (2) CONFORMING AMENDMENT.—The Food and 

4 Drug Administration Safety and Innovation Act 

5 (Public Law 112–144) is amended in the table of 

6 contents in section 2 by striking the item relating to 

7 section 207. 

8 TITLE III—FEES RELATING TO 

9 GENERIC DRUGS 

10 SEC. 301. SHORT TITLE; FINDING. 

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

12 ‘‘Generic Drug User Fee Amendments of 2017’’. 

13 (b) FINDING.—The Congress finds that the fees au14 thorized by the amendments made in this title will be dedi15 cated to human generic drug activities, as set forth in the 

16 goals identified for purposes of part 7 of subchapter C 

17 of chapter VII of the Federal Food, Drug, and Cosmetic 

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

19 Human Services to the Chairman of the Committee on 

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

21 the Chairman of the Committee on Energy and Commerce 

22 of the House of Representatives, as set forth in the Con23 gressional Record. 


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1 SEC. 302. DEFINITIONS. 

2 Section 744A of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379j–41) is amended— 

4 (1) in paragraph (1)(B), by striking ‘‘applica5 tion for a positron emission tomography drug.’’ and 

6 inserting ‘‘application— 

7 ‘‘(i) for a positron emission tomog8 raphy drug; or 

9 ‘‘(ii) submitted by a State or Federal 

10 governmental entity for a drug that is not 

11 distributed commercially.’’; 

12 (2) by redesignating paragraphs (5) through 

13 (12) as paragraphs (6) through (13), respectively; 

14 and 

15 (3) by inserting after paragraph (4) the fol16 lowing: 

17 ‘‘(5) The term ‘contract manufacturing organi18 zation facility’ means a manufacturing facility of a 

19 finished dosage form of a drug approved pursuant to 

20 an abbreviated new drug application, where such 

21 manufacturing facility is not identified in an ap22 proved abbreviated new drug application held by the 

23 owner of such facility or an affiliate of such owner 

24 or facility.’’. 


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1 SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GE2 NERIC DRUG FEES. 

3 (a) TYPES OF FEES.—Section 744B(a) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

5 42(a)) is amended— 

6 (1) in the matter preceding paragraph (1), by 

7 striking ‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 

8 2018’’; 

9 (2) in paragraph (1), by adding at the end the 

10 following: 

11 ‘‘(E) SUNSET.—This paragraph shall cease 

12 to be effective October 1, 2022.’’; 

13 (3) in paragraph (2)— 

14 (A) by amending subparagraph (C) to read 

15 as follows: 

16 ‘‘(C) NOTICE.—Not later than 60 days be17 fore the start of each of fiscal years 2018 

18 through 2022, the Secretary shall publish in the 

19 Federal Register the amount of the drug mas20 ter file fee established by this paragraph for 

21 such fiscal year.’’; and 

22 (B) in subparagraph (E)— 

23 (i) in clause (i)— 

24 (I) by striking ‘‘no later than the 

25 date’’ and inserting ‘‘on the earlier 

26 of— 


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1 ‘‘(I) the date’’; 

2 (II) by striking the period and 

3 inserting ‘‘; or’’; and 

4 (III) by adding at the end the 

5 following: 

6 ‘‘(II) the date on which the drug 

7 master file holder requests the initial 

8 completeness assessment.’’; and 

9 (ii) in clause (ii), by striking ‘‘notice 

10 provided for in clause (i) or (ii) of subpara11 graph (C), as applicable’’ and inserting 

12 ‘‘notice provided for in subparagraph (C)’’; 

13 (4) in paragraph (3)— 

14 (A) in the heading, by striking ‘‘AND

15 PRIOR APPROVAL SUPPLEMENT’’; 

16 (B) in subparagraph (A), by striking ‘‘or a 

17 prior approval supplement to an abbreviated 

18 new drug application’’; 

19 (C) by amending subparagraphs (B) and 

20 (C) to read as follows: 

21 ‘‘(B) NOTICE.—Not later than 60 days be22 fore the start of each of fiscal years 2018 

23 through 2022, the Secretary shall publish in the 

24 Federal Register the amount of the fees under 

25 subparagraph (A) for such fiscal year. 


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1 ‘‘(C) FEE DUE DATE.—The fees required 

2 by subparagraphs (A) and (F) shall be due no 

3 later than the date of submission of the abbre4 viated new drug application or prior approval 

5 supplement for which such fee applies.’’; 

6 (D) in subparagraph (D)— 

7 (i) in the heading, by inserting ‘‘, IS

8 WITHDRAWN PRIOR TO BEING RECEIVED, 

9 OR IS NO LONGER RECEIVED’’ after ‘‘RE10 CEIVED’’; and 

11 (ii) by striking ‘‘The Secretary shall’’ 

12 and all that follows through the period and 

13 inserting the following: 

14 ‘‘(i) APPLICATIONS NOT CONSIDERED

15 TO HAVE BEEN RECEIVED AND APPLICA16 TIONS WITHDRAWN PRIOR TO BEING RE17 CEIVED.—The Secretary shall refund 75 

18 percent of the fee paid under subparagraph 

19 (A) for any abbreviated new drug applica20 tion that the Secretary considers not to 

21 have been received within the meaning of 

22 section 505(j)(5)(A) for a cause other than 

23 failure to pay fees, or that has been with24 drawn prior to being received within the 

25 meaning of section 505(j)(5)(A). 


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1 ‘‘(ii) APPLICATIONS NO LONGER RE2 CEIVED.—The Secretary shall refund 100 

3 percent of the fee paid under subparagraph 

4 (A) for any abbreviated new drug applica5 tion if the Secretary initially receives the 

6 application under section 505(j)(5)(A) and 

7 subsequently determines that an exclusivity 

8 period for a listed drug should have pre9 vented the Secretary from receiving such 

10 application, such that the abbreviated new 

11 drug application is no longer received with12 in the meaning of section 505(j)(5)(A).’’; 

13 (E) in subparagraph (E), by striking ‘‘or 

14 prior approval supplement’’; and 

15 (F) in the matter preceding clause (i) of 

16 subparagraph (F)— 

17 (i) by striking ‘‘2012’’ and inserting 

18 ‘‘2017’’; and 

19 (ii) by striking ‘‘subsection (d)(3)’’ 

20 and inserting ‘‘subsection (d)(2)’’; 

21 (5) in paragraph (4)— 

22 (A) in subparagraph (A)— 

23 (i) in the matter preceding clause (i) 

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1 neric drug submission that is pending or’’ 

2 and inserting ‘‘in at least one generic drug 

3 submission that is’’; 

4 (ii) in clause (i), by striking ‘‘or in5 tended to be identified in at least one ge6 neric drug submission that is pending or’’ 

7 and inserting ‘‘in at least one generic drug 

8 submission that is’’; 

9 (iii) in clause (ii), by striking ‘‘pro10 duces,’’ and all that follows through ‘‘such 

11 a’’ and inserting ‘‘is identified in at least 

12 one generic drug submission in which the 

13 facility is approved to produce one or more 

14 active pharmaceutical ingredients or in a 

15 Type II active pharmaceutical ingredient 

16 drug master file referenced in at least one 

17 such’’; and 

18 (iv) in clause (iii), by striking ‘‘to fees 

19 under both such clauses’’ and inserting 

20 ‘‘only to the fee attributable to the manu21 facture of the finished dosage forms’’; and 

22 (B) by amending subparagraphs (C) and 

23 (D) to read as follows: 

24 ‘‘(C) NOTICE.—Within the timeframe spec25 ified in subsection (d)(1), the Secretary shall 


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1 publish in the Federal Register the amount of 

2 the fees under subparagraph (A) for such fiscal 

3 year.’’. 

4 ‘‘(D) FEE DUE DATE.—For each of fiscal 

5 years 2018 through 2022, the fees under sub6 paragraph (A) for such fiscal year shall be due 

7 on the later of— 

8 ‘‘(i) the first business day on or after 

9 October 1 of each such year; or 

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

11 enactment of an appropriations Act pro12 viding for the collection and obligation of 

13 fees for such year under this section for 

14 such year.’’; 

15 (6) by redesignating paragraph (5) as para16 graph (6); and 

17 (7) by inserting after paragraph (4) the fol18 lowing: 

19 ‘‘(5) GENERIC DRUG APPLICANT PROGRAM

20 FEE.— 

21 ‘‘(A) IN GENERAL.—A generic drug appli22 cant program fee shall be assessed annually as 

23 described in subsection (b)(2)(E). 


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1 ‘‘(B) AMOUNT.—The amount of fees estab2 lished under subparagraph (A) shall be estab3 lished under subsection (d). 

4 ‘‘(C) NOTICE.—Within the timeframe spec5 ified in subsection (d)(1), the Secretary shall 

6 publish in the Federal Register the amount of 

7 the fees under subparagraph (A) for such fiscal 

8 year. 

9 ‘‘(D) FEE DUE DATE.—For each of fiscal 

10 years 2018 through 2022, the fees under sub11 paragraph (A) for such fiscal year shall be due 

12 on the later of— 

13 ‘‘(i) the first business day on or after 

14 October 1 of each such fiscal year; or 

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

16 date of enactment of an appropriations Act 

17 providing for the collection and obligation 

18 of fees for such fiscal year under this sec19 tion for such fiscal year.’’. 

20 (b) FEE REVENUE AMOUNTS.—Section 744B(b) of 

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

22 379j–42(b)) is amended— 

23 (1) in paragraph (1)— 

24 (A) in subparagraph (A)— 


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1 (i) in the heading, by striking ‘‘2013’’ 

2 and inserting ‘‘2018’’; 

3 (ii) by striking ‘‘2013’’ and inserting 

4 ‘‘2018’’; 

5 (iii) by striking ‘‘$299,000,000’’ and 

6 inserting ‘‘$493,600,000’’; and 

7 (iv) by striking ‘‘Of that amount’’ and 

8 all that follows through the end of clause 

9 (ii); and 

10 (B) in subparagraph (B)— 

11 (i) in the heading, by striking ‘‘2014

12 THROUGH 2017’’ and inserting ‘‘2019

13 THROUGH 2022’’; 

14 (ii) by striking ‘‘2014 through 2017’’ 

15 and inserting ‘‘2019 through 2022’’; 

16 (iii) by striking ‘‘paragraphs (2) 

17 through (4)’’ and inserting ‘‘paragraphs 

18 (2) through (5)’’; and 

19 (iv) by striking ‘‘$299,000,000’’ and 

20 inserting ‘‘$493,600,000’’; and 

21 (2) in paragraph (2)— 

22 (A) in the matter preceding subparagraph 

23 (A)— 

24 (i) by striking ‘‘paragraph (1)(A)(ii) 

25 for fiscal year 2013 and paragraph (1)(B) 


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1 for each of fiscal years 2014 through 

2 2017’’ and inserting ‘‘such paragraph for a 

3 fiscal year’’; and 

4 (ii) by striking ‘‘through (4)’’ and in5 serting ‘‘through (5)’’; 

6 (B) in subparagraph (A), by striking ‘‘Six 

7 percent’’ and inserting ‘‘Five percent’’; 

8 (C) by amending subparagraphs (B) and 

9 (C) to read as follows: 

10 ‘‘(B) Thirty-three percent shall be derived 

11 from fees under subsection (a)(3) (relating to 

12 abbreviated new drug applications). 

13 ‘‘(C) Twenty percent shall be derived from 

14 fees under subsection (a)(4)(A)(i) (relating to 

15 generic drug facilities). The amount of the fee 

16 for a contract manufacturing organization facil17 ity shall be equal to one-third the amount of the 

18 fee for a facility that is not a contract manufac19 turing organization facility. The amount of the 

20 fee for a facility located outside the United 

21 States and its territories and possessions shall 

22 be $15,000 higher than the amount of the fee 

23 for a facility located in the United States and 

24 its territories and possessions.’’; 

25 (D) in subparagraph (D)— 


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1 (i) by striking ‘‘Fourteen percent’’ 

2 and inserting ‘‘Seven percent’’; 

3 (ii) by striking ‘‘not less than $15,000 

4 and not more than $30,000’’ and inserting 

5 ‘‘$15,000’’; and 

6 (iii) by striking ‘‘, as determined’’ and 

7 all that follows through the period at the 

8 end and inserting a period; and 

9 (E) by adding at the end the following: 

10 ‘‘(E)(i) Thirty-five percent shall be derived 

11 from fees under subsection (a)(5) (relating to 

12 generic drug applicant program fees). For pur13 poses of this subparagraph, if a person has af14 filiates, a single program fee shall be assessed 

15 with respect to that person, including its affili16 ates, and may be paid by that person or any 

17 one of its affiliates. The Secretary shall deter18 mine the fees as follows: 

19 ‘‘(I) If a person (including its affili20 ates) owns at least one but not more than 

21 5 approved abbreviated new drug applica22 tions on the due date for the fee under this 

23 subsection, the person (including its affili24 ates) shall be assessed a small business ge25 neric drug applicant program fee equal to 


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1 one-tenth of the large size operation ge2 neric drug applicant program fee. 

3 ‘‘(II) If a person (including its affili4 ates) owns at least 6 but not more than 19 

5 approved abbreviated new drug applica6 tions on the due date for the fee under this 

7 subsection, the person (including its affili8 ates) shall be assessed a medium size oper9 ation generic drug applicant program fee 

10 equal to two-fifths of the large size oper11 ation generic drug applicant program fee. 

12 ‘‘(III) If a person (including its affili13 ates) owns 20 or more approved abbre14 viated new drug applications on the due 

15 date for the fee under this subsection, the 

16 person (including its affiliates) shall be as17 sessed a large size operation generic drug 

18 applicant program fee. 

19 ‘‘(ii) For purposes of this subparagraph, 

20 an abbreviated new drug application shall be 

21 deemed not to be approved if the applicant has 

22 submitted a written request for withdrawal of 

23 approval of such abbreviated new drug applica24 tion by April 1 of the previous fiscal year.’’. 


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1 (c) ADJUSTMENTS.—Section 744B(c) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is 

3 amended— 

4 (1) in paragraph (1)— 

5 (A) by striking ‘‘2014’’ and inserting 

6 ‘‘2019’’; 

7 (B) by inserting ‘‘to equal the product of 

8 the total revenues established in such notice for 

9 the prior fiscal year multiplied’’ after ‘‘a fiscal 

10 year,’’; and 

11 (C) by striking the flush text following 

12 subparagraph (C); and 

13 (2) in paragraph (2)— 

14 (A) by striking ‘‘2017’’ each place it ap15 pears and inserting ‘‘2022’’; and 

16 (B) by striking ‘‘2018’’ and inserting 

17 ‘‘2023’’. 

18 (d) ANNUAL FEE SETTING.—Section 744B of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

20 42) is amended— 

21 (1) in subsection (c)(2), by striking ‘‘Such fees 

22 may only be used in fiscal year 2018.’’; and 

23 (2) in subsection (d)— 

24 (A) by striking paragraphs (1) and (2) and 

25 inserting the following: 


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1 ‘‘(1) FISCAL YEARS 2018 THROUGH 2022.—Not 

2 more than 60 days before the first day of each of 

3 fiscal years 2018 through 2022, the Secretary shall 

4 establish the fees described in paragraphs (2) 

5 through (5) of subsection (a), based on the revenue 

6 amounts established under subsection (b) and the 

7 adjustments provided under subsection (c).’’; 

8 (B) by redesignating paragraph (3) as 

9 paragraph (2); and 

10 (C) in paragraph (2) (as so redesignated), 

11 in the matter preceding subparagraph (A), by 

12 striking ‘‘fees under paragraphs (1) and (2)’’ 

13 and inserting ‘‘fee under paragraph (1)’’. 

14 (e) IDENTIFICATION OF FACILITIES.—Section 

15 744B(f) of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 379j–42(f)) is amended— 

17 (1) by striking paragraph (1); 

18 (2) by redesignating paragraphs (2) through 

19 (4) as paragraphs (1) through (3), respectively; 

20 (3) in paragraph (1) (as so redesignated)— 

21 (A) by striking ‘‘paragraph (4)’’ and in22 serting ‘‘paragraph (3)’’; and 

23 (B) by striking ‘‘Such information shall’’ 

24 and all that follows through the end of subpara25 graph (B) and inserting ‘‘Such information 


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1 shall, for each fiscal year, be submitted, up2 dated, or reconfirmed on or before June 1 of 

3 the previous fiscal year.’’; and 

4 (4) in paragraph (2), as so redesignated— 

5 (A) in the heading, by striking ‘‘CONTENTS

6 OF NOTICE’’ and inserting ‘‘INFORMATION RE7 QUIRED TO BE SUBMITTED’’; 

8 (B) in the matter preceding subparagraph 

9 (A), by striking ‘‘paragraph (2)’’ and inserting 

10 ‘‘paragraph (1)’’; 

11 (C) in subparagraph (A), by striking ‘‘or 

12 intended to be identified’’; 

13 (D) in subparagraph (D), by striking 

14 ‘‘and’’ at the end; 

15 (E) in subparagraph (E), by striking the 

16 period and inserting ‘‘; and’’; and 

17 (F) by adding at the end the following: 

18 ‘‘(F) whether the facility is a contract 

19 manufacturing organization facility.’’. 

20 (f) EFFECT OF FAILURE TO PAY FEES.—Section 

21 744B(g) of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 379–42(g)) is amended— 

23 (1) in paragraph (1), by adding at the end the 

24 following: ‘‘This paragraph shall cease to be effective 

25 on October 1, 2022.’’; 


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1 (2) in paragraph (2)(C)(ii), by striking ‘‘of 

2 505(j)(5)(A)’’ and inserting ‘‘of section 

3 505(j)(5)(A)’’; and 

4 (3) by adding at the end the following: 

5 ‘‘(5) GENERIC DRUG APPLICANT PROGRAM

6 FEE.— 

7 ‘‘(A) IN GENERAL.—A person who fails to 

8 pay a fee as required under subsection (a)(5) by 

9 the date that is 20 calendar days after the due 

10 date, as specified in subparagraph (D) of such 

11 subsection, shall be subject to the following: 

12 ‘‘(i) The Secretary shall place the per13 son on a publicly available arrears list. 

14 ‘‘(ii) Any abbreviated new drug appli15 cation submitted by the generic drug appli16 cant or an affiliate of such applicant shall 

17 not be received, within the meaning of sec18 tion 505(j)(5)(A). 

19 ‘‘(iii) All drugs marketed pursuant to 

20 any abbreviated new drug application held 

21 by such applicant or an affiliate of such 

22 applicant shall be deemed misbranded 

23 under section 502(aa). 

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

25 penalties under subparagraph (A) shall apply 


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1 until the fee required under subsection (a)(5) is 

2 paid.’’. 

3 (g) LIMITATIONS.—Section 744B(h)(2) of the Fed4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379– 

5 42(h)(2)) is amended by striking ‘‘for Type II active phar6 maceutical ingredient drug master files, abbreviated new 

7 drug applications and prior approval supplements, and ge8 neric drug facilities and active pharmaceutical ingredient 

9 facilities’’. 

10 (h) CREDITING AND AVAILABILITY OF FEES.—Sec11 tion 744B(i) of the Federal Food, Drug, and Cosmetic Act 

12 (21 U.S.C. 379–42(i)) is amended— 

13 (1) in paragraph (2)— 

14 (A) by striking subparagraph (C) (relating 

15 to fee collection during first program year); 

16 (B) in subparagraph (D)— 

17 (i) in the heading, by striking ‘‘IN

18 SUBSEQUENT YEARS’’; and 

19 (ii) by striking ‘‘(after fiscal year 

20 2013)’’; and 

21 (C) by redesignating subparagraph (D) as 

22 subparagraph (C); and 

23 (2) in paragraph (3), by striking ‘‘fiscal years 

24 2013 through 2017’’ and inserting ‘‘fiscal years 

25 2018 through 2022’’. 


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1 (i) INFORMATION ON ABBREVIATED NEW DRUG AP2 PLICATIONS HELD BY APPLICANTS AND THEIR AFFILI3 ATES.—Section 744B of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 379–42) is amended by adding 

5 at the end the following: 

6 ‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG

7 APPLICATIONS OWNED BY APPLICANTS AND THEIR AF8 FILIATES.— 

9 ‘‘(1) IN GENERAL.—By April 1 of each year, 

10 each person that owns an abbreviated new drug ap11 plication, or any affiliate of such person, shall sub12 mit to the Secretary a list of— 

13 ‘‘(A) all approved abbreviated new drug 

14 applications owned by such person; and 

15 ‘‘(B) if any affiliate of such person also 

16 owns an abbreviated new drug application, all 

17 approved abbreviated new drug applications 

18 owned by any such affiliate. 

19 ‘‘(2) FORMAT AND METHOD.—The Secretary 

20 shall specify in guidance the format and method for 

21 submission of lists under this subsection.’’. 

22 SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS. 

23 Section 744C of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 379j–43) is amended— 

25 (1) in subsection (a)— 


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1 (A) by striking ‘‘2013’’ and inserting 

2 ‘‘2018’’; and 

3 (B) by striking ‘‘Generic Drug User Fee 

4 Amendments of 2012’’ and inserting ‘‘Generic 

5 Drug User Fee Amendments of 2017’’; 

6 (2) in subsection (b), by striking ‘‘2013’’ and 

7 inserting ‘‘2018’’; and 

8 (3) in subsection (d), by striking ‘‘2017’’ each 

9 place it appears and inserting ‘‘2022’’. 

10 SEC. 305. SUNSET DATES. 

11 (a) AUTHORIZATION.—Sections 744A and 744B of 

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

13 379j–41; 379j–42) shall cease to be effective October 1, 

14 2022. 

15 (b) REPORTING REQUIREMENTS.—Section 744C of 

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

17 379j–43) shall cease to be effective January 31, 2023. 

18 (c) PREVIOUS SUNSET PROVISION.—Effective Octo19 ber 1, 2017, subsections (a) and (b) of section 304 of the 

20 Food and Drug Administration Safety and Innovation Act 

21 (Public Law 112–144) are repealed. 

22 SEC. 306. EFFECTIVE DATE. 

23 The amendments made by this title shall take effect 

24 on October 1, 2017, or the date of the enactment of this 

25 Act, whichever is later, except that fees under part 7 of 


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1 subchapter C of chapter VII of the Federal Food, Drug, 

2 and Cosmetic Act shall be assessed for all abbreviated new 

3 drug applications received on or after October 1, 2017, 

4 regardless of the date of the enactment of this Act. 

5 SEC. 307. SAVINGS CLAUSE. 

6 Notwithstanding the amendments made by this title, 

7 part 7 of subchapter C of chapter VII of the Federal Food, 

8 Drug, and Cosmetic Act, as in effect on the day before 

9 the date of the enactment of this title, shall continue to 

10 be in effect with respect to abbreviated new drug applica11 tions (as defined in such part as of such day) that on or 

12 after October 1, 2012, but before October 1, 2017, were 

13 received by the Food and Drug Administration within the 

14 meaning of 505(j)(5)(A) of such Act (21 U.S.C. 

15 355(j)(5)(A)), prior approval supplements that were sub16 mitted, and drug master files for Type II active pharma17 ceutical ingredients that were first referenced with respect 

18 to assessing and collecting any fee required by such part 

19 for a fiscal year prior to fiscal year 2018. 

20 TITLE IV—FEES RELATING TO 

21 BIOSIMILAR BIOLOGICAL 

22 PRODUCTS 

23 SEC. 401. SHORT TITLE; FINDING. 

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

25 ‘‘Biosimilar User Fee Amendments of 2017’’. 


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1 (b) FINDING.—The Congress finds that the fees au2 thorized by the amendments made in this title will be dedi3 cated to expediting the process for the review of biosimilar 

4 biological product applications, including postmarket safe5 ty activities, as set forth in the goals identified for pur6 poses of part 8 of subchapter C of chapter VII of the Fed7 eral Food, Drug, and Cosmetic Act, in the letters from 

8 the Secretary of Health and Human Services to the Chair9 man of the Committee on Health, Education, Labor, and 

10 Pensions of the Senate and the Chairman of the Com11 mittee on Energy and Commerce of the House of Rep12 resentatives, as set forth in the Congressional Record. 

13 SEC. 402. DEFINITIONS. 

14 (a) ADJUSTMENT FACTOR.—Section 744G(1) of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

16 51(1)) is amended to read as follows: 

17 ‘‘(1) The term ‘adjustment factor’ applicable to 

18 a fiscal year is the Consumer Price Index for all 

19 urban consumers (all items; United States city aver20 age) for October of the preceding fiscal year divided 

21 by such Index for October 2011.’’. 

22 (b) BIOSIMILAR BIOLOGICAL PRODUCT.—Section 

23 744G(3) of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 379j–51(3)) is amended by striking ‘‘means 


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1 a product’’ and inserting ‘‘means a specific strength of 

2 a biological product in final dosage form’’. 

3 SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR 

4 FEES. 

5 (a) TYPES OF FEES.—Section 744H(a) of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

7 52(a)) is amended— 

8 (1) in the matter preceding paragraph (1), by 

9 striking ‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 

10 2018’’; 

11 (2) in the heading of paragraph (1), by striking 

12 ‘‘BIOSIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGI13 CAL PRODUCT’’; 

14 (3) in paragraph (1)(A)(i), by striking 

15 ‘‘(b)(1)(A)’’ and inserting ‘‘(c)(5)’’; 

16 (4) in paragraph (1)(B)(i), by striking 

17 ‘‘(b)(1)(B) for biosimilar biological product develop18 ment’’ and inserting ‘‘(c)(5) for the biosimilar bio19 logical product development program’’; 

20 (5) in paragraph (1)(B)(ii), by striking ‘‘annual 

21 biosimilar biological product development program 

22 fee’’ and inserting ‘‘annual biosimilar biological 

23 product development fee’’; 

24 (6) in paragraph (1)(B)(iii), by striking ‘‘an25 nual biosimilar development program fee’’ and inVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6401 E:\BILLS\S934.RS S934

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1 serting ‘‘annual biosimilar biological product devel2 opment fee’’; 

3 (7) in paragraph (1)(B), by adding at the end 

4 the following: 

5 ‘‘(iv) REFUND.—If a person submits a 

6 marketing application for a biosimilar bio7 logical product before October 1 of a fiscal 

8 year and such application is accepted for 

9 filing on or after October 1 of such fiscal 

10 year, the person may request a refund 

11 equal to the annual biosimilar development 

12 fee paid by the person for the product for 

13 such fiscal year. To qualify for consider14 ation for a refund under this clause, a per15 son shall submit to the Secretary a written 

16 request for such refund not later than 180 

17 days after the marketing application is ac18 cepted for filing.’’; 

19 (8) in paragraph (1)(C), by striking ‘‘for a 

20 product effective October 1 of a fiscal year by,’’ and 

21 inserting ‘‘for a product, effective October 1 of a fis22 cal year, by,’’; 

23 (9) in paragraph (1)(D)— 

24 (A) in clause (i) in the matter preceding 

25 subclause (I), by inserting ‘‘, if the person seeks 


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1 to resume participation in such program,’’ be2 fore ‘‘pay a fee’’; 

3 (B) in clause (i)(I), by inserting after 

4 ‘‘grants a request’’ the following: ‘‘by such per5 son’’; and 

6 (C) in clause (i)(II), by inserting after 

7 ‘‘discontinued)’’ the following: ‘‘by such per8 son’’; 

9 (10) in the heading of paragraph (1)(E), by 

10 striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; 

11 (11) in the heading of subparagraph (F) of 

12 paragraph (1), by striking ‘‘BIOSIMILAR DEVELOP13 MENT PROGRAM FEES’’ and inserting ‘‘BIOSIMILAR

14 BIOLOGICAL PRODUCT DEVELOPMENT FEES’’; 

15 (12) in paragraph (1)(F)— 

16 (A) in the heading of subparagraph (F), by 

17 striking ‘‘BIOSIMILAR DEVELOPMENT PRO18 GRAM’’ before ‘‘FEES’’; and 

19 (B) by amending clause (i) to read as fol20 lows: 

21 ‘‘(i) REFUNDS.—Except as provided 

22 in subparagraph (B)(iv), the Secretary 

23 shall not refund any initial or annual bio24 similar biological product development fee 

25 paid under subparagraph (A) or (B), or 


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1 any reactivation fee paid under subpara2 graph (D).’’; 

3 (13) in paragraph (2)— 

4 (A) in the heading of paragraph (2), by 

5 striking ‘‘AND SUPPLEMENT’’; 

6 (B) by amending subparagraphs (A) and 

7 (B) to read as follows: 

8 ‘‘(A) IN GENERAL.—Each person that sub9 mits, on or after October 1, 2017, a biosimilar 

10 biological product application shall be subject to 

11 the following fees: 

12 ‘‘(i) A fee established under sub13 section (c)(5) for a biosimilar biological 

14 product application for which clinical data 

15 (other than comparative bioavailability 

16 studies) with respect to safety or effective17 ness are required for approval. 

18 ‘‘(ii) A fee established under sub19 section (c)(5) for a biosimilar biological 

20 product application for which clinical data 

21 (other than comparative bioavailability 

22 studies) with respect to safety or effective23 ness are not required for approval. Such 

24 fee shall be equal to half of the amount of 

25 the fee described in clause (i). 


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1 ‘‘(B) RULE OF APPLICABILITY; TREAT2 MENT OF CERTAIN PREVIOUSLY PAID FEES.— 

3 Any person who pays a fee under subparagraph 

4 (A), (B), or (D) of paragraph (1) for a product 

5 before October 1, 2017, but submits a bio6 similar biological product application for that 

7 product after such date, shall— 

8 ‘‘(i) be subject to any biosimilar bio9 logical product application fees that may 

10 be assessed at the time when such bio11 similar biological product application is 

12 submitted; and 

13 ‘‘(ii) be entitled to no reduction of 

14 such application fees based on the amount 

15 of fees paid for that product before Octo16 ber 1, 2017, under such subparagraph (A), 

17 (B), or (D).’’; 

18 (C) in the heading of subparagraph (D), 

19 by striking ‘‘OR SUPPLEMENT’’; and 

20 (D) in subparagraphs (C) through (F)— 

21 (i) by striking ‘‘or supplement’’ each 

22 place it appears; and 

23 (ii) in subparagraph (D), by striking 

24 ‘‘or a supplement’’; and 


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1 (14) by amending paragraph (3) to read as fol2 lows: 

3 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT PRO4 GRAM FEE.— 

5 ‘‘(A) IN GENERAL.—Each person who is 

6 named as the applicant in a biosimilar biologi7 cal product application shall pay the annual bio8 similar biological product program fee estab9 lished for a fiscal year under subsection (c)(5) 

10 for each biosimilar biological product that— 

11 ‘‘(i) is identified in such a biosimilar 

12 biological product application approved as 

13 of October 1 of such fiscal year; and 

14 ‘‘(ii) as of October 1 of such fiscal 

15 year, does not appear on a list, developed 

16 and maintained by the Secretary, of dis17 continued biosimilar biological products. 

18 ‘‘(B) DUE DATE.—The biosimilar biologi19 cal product program fee for a fiscal year shall 

20 be due on the later of— 

21 ‘‘(i) the first business day on or after 

22 October 1 of each such year; or 

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

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1 viding for the collection and obligation of 

2 fees for such year under this section. 

3 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

4 The biosimilar biological product program fee 

5 shall be paid only once for each product for 

6 each fiscal year. 

7 ‘‘(D) LIMITATION.—A person who is 

8 named as the applicant in a biosimilar biologi9 cal product application shall not be assessed 

10 more than 5 biosimilar biological product pro11 gram fees for a fiscal year for biosimilar bio12 logical products identified in such biosimilar bi13 ological product application.’’. 

14 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec15 tion 744H of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 379j–52) is amended to read as follows: 

17 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

19 fees under subsection (a) shall be established to gen20 erate a total revenue amount equal to the sum of— 

21 ‘‘(A) $45,000,000; and 

22 ‘‘(B) the dollar amount equal to the fiscal 

23 year 2018 adjustment (as determined under 

24 subsection (c)(4)). 


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

2 the fiscal years 2019 through 2022, fees under sub3 section (a) shall, except as provided in subsection 

4 (c), be established to generate a total revenue 

5 amount equal to the sum of— 

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

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

8 ‘‘(B) the dollar amount equal to the infla9 tion adjustment for the fiscal year (as deter10 mined under subsection (c)(1)); 

11 ‘‘(C) the dollar amount equal to the capac12 ity planning adjustment for the fiscal year (as 

13 determined under subsection (c)(2)); and 

14 ‘‘(D) the dollar amount equal to the oper15 ating reserve adjustment for the fiscal year, if 

16 applicable (as determined under subsection 

17 (c)(3)). 

18 ‘‘(3) ALLOCATION OF REVENUE AMOUNT

19 AMONG FEES; LIMITATIONS ON FEE AMOUNTS.— 

20 ‘‘(A) ALLOCATION.—The Secretary shall 

21 determine the percentage of the total revenue 

22 amount for a fiscal year to be derived from, re23 spectively— 


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1 ‘‘(i) initial and annual biosimilar de2 velopment fees and reactivation fees under 

3 subsection (a)(1); 

4 ‘‘(ii) biosimilar biological product ap5 plication fees under subsection (a)(2); and 

6 ‘‘(iii) biosimilar biological product pro7 gram fees under subsection (a)(3). 

8 ‘‘(B) LIMITATIONS ON FEE AMOUNTS.— 

9 Until the first fiscal year for which the capacity 

10 planning adjustment under subsection (c)(2) is 

11 effective, the amount of any fee under sub12 section (a) for a fiscal year after fiscal year 

13 2018 shall not exceed 125 percent of the 

14 amount of such fee for fiscal year 2018. 

15 ‘‘(C) BIOSIMILAR BIOLOGICAL PRODUCT

16 DEVELOPMENT FEES.—The initial biosimilar bi17 ological product development fee under sub18 section (a)(1)(A) for a fiscal year shall be equal 

19 to the annual biosimilar biological product de20 velopment fee under subsection (a)(1)(B) for 

21 that fiscal year. 

22 ‘‘(D) REACTIVATION FEE.—The reactiva23 tion fee under subsection (a)(1)(D) for a fiscal 

24 year shall be equal to twice the amount of the 

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1 ment fee under subsection (a)(1)(B) for that 

2 fiscal year. 

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

4 of paragraph (2), the dollar amount of the annual 

5 base revenue for a fiscal year shall be the dollar 

6 amount of the total revenue amount for the previous 

7 fiscal year, excluding any adjustments to such rev8 enue amount under subsection (c)(3).’’. 

9 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

10 744H of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 379j–52) is amended— 

12 (1) by redesignating subsections (c) through (h) 

13 as subsections (d) through (i), respectively; 

14 (2) in subsections (a)(2)(F) and (g), by striking 

15 ‘‘subsection (c)’’ and inserting ‘‘subsection (d)’’; 

16 (3) in subsection (a)(4)(A), by striking ‘‘sub17 section (b)(1)(F)’’ and inserting ‘‘subsection (c)(5)’’; 

18 and 

19 (4) by inserting after subsection (b) the fol20 lowing: 

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

22 ‘‘(1) INFLATION ADJUSTMENT.— 

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


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1 for each fiscal year shall be equal to the prod2 uct of— 

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

4 fiscal year under subsection (b); and 

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

7 ‘‘(B) INFLATION ADJUSTMENT PERCENT8 AGE.—The inflation adjustment percentage 

9 under this subparagraph for a fiscal year is 

10 equal to the sum of— 

11 ‘‘(i) the average annual percent 

12 change in the cost, per full-time equivalent 

13 position of the Food and Drug Administra14 tion, of all personnel compensation and 

15 benefits paid with respect to such positions 

16 for the first 3 years of the preceding 4 fis17 cal years, multiplied by the proportion of 

18 personnel compensation and benefits costs 

19 to total costs of the process for the review 

20 of biosimilar biological product applications 

21 (as defined in section 744G(13)) for the 

22 first 3 years of the preceding 4 fiscal 

23 years; and 

24 ‘‘(ii) the average annual percent 

25 change that occurred in the Consumer 


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1 Price Index for urban consumers (Wash2 ington-Baltimore, DC–MD–VA–WV; Not 

3 Seasonally Adjusted; All items; Annual 

4 Index) for the first 3 years of the pre5 ceding 4 years of available data multiplied 

6 by the proportion of all costs other than 

7 personnel compensation and benefits costs 

8 to total costs of the process for the review 

9 of biosimilar biological product applications 

10 (as defined in section 744G(13)) for the 

11 first 3 years of the preceding 4 fiscal 

12 years. 

13 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

14 ‘‘(A) IN GENERAL.—Beginning with the 

15 fiscal year described in subparagraph 

16 (B)(ii)(II), the Secretary shall, in addition to 

17 the adjustment under paragraph (1), further in18 crease the fee revenue and fees under this sec19 tion for a fiscal year to reflect changes in the 

20 resource capacity needs of the Secretary for the 

21 process for the review of biosimilar biological 

22 product applications. 

23 ‘‘(B) CAPACITY PLANNING METHOD24 OLOGY.— 


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1 ‘‘(i) DEVELOPMENT; EVALUATION

2 AND REPORT.—The Secretary shall obtain, 

3 through a contract with an independent ac4 counting or consulting firm, a report evalu5 ating options and recommendations for a 

6 new methodology to accurately assess 

7 changes in the resource and capacity needs 

8 of the process for the review of biosimilar 

9 biological product applications. The capac10 ity planning methodological options and 

11 recommendations presented in such report 

12 shall utilize and be informed by personnel 

13 time reporting data as an input. The re14 port shall be published for public comment 

15 not later than September 30, 2020. 

16 ‘‘(ii) ESTABLISHMENT AND IMPLE17 MENTATION.—After review of the report 

18 described in clause (i) and receipt and re19 view of public comments thereon, the Sec20 retary shall establish a capacity planning 

21 methodology for purposes of this para22 graph, which shall— 

23 ‘‘(I) incorporate such approaches 

24 and attributes as the Secretary deter25 mines appropriate; and 


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1 ‘‘(II) be effective beginning with 

2 the first fiscal year for which fees are 

3 set after such capacity planning meth4 odology is established. 

5 ‘‘(C) LIMITATION.—Under no cir6 cumstances shall an adjustment under this 

7 paragraph result in fee revenue for a fiscal year 

8 that is less than the sum of the amounts under 

9 subsections (b)(2)(A) (the annual base revenue 

10 for the fiscal year) and (b)(2)(B) (the dollar 

11 amount of the inflation adjustment for the fis12 cal year). 

13 ‘‘(D) PUBLICATION IN FEDERAL REG14 ISTER.—The Secretary shall publish in the Fed15 eral Register notice under paragraph (5) the fee 

16 revenue and fees resulting from the adjustment 

17 and the methodologies under this paragraph. 

18 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

19 ‘‘(A) INTERIM APPLICATION; FEE REDUC20 TION.—Until the first fiscal year for which the 

21 capacity planning adjustment under paragraph 

22 (2) is effective, the Secretary may, in addition 

23 to the adjustment under paragraph (1), reduce 

24 the fee revenue and fees under this section for 

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1 priate for long-term financial planning pur2 poses. 

3 ‘‘(B) GENERAL APPLICATION AND METH4 ODOLOGY.—Beginning with the first fiscal year 

5 for which the capacity planning adjustment 

6 under paragraph (2) is effective, the Secretary 

7 may, in addition to the adjustments under 

8 paragraphs (1) and (2)— 

9 ‘‘(i) reduce the fee revenue and fees 

10 under this section as the Secretary deter11 mines appropriate for long-term financial 

12 planning purposes; or 

13 ‘‘(ii) increase the fee revenue and fees 

14 under this section if such an adjustment is 

15 necessary to provide for not more than 21 

16 weeks of operating reserves of carryover 

17 user fees for the process for the review of 

18 biosimilar biological product applications. 

19 ‘‘(C) FEDERAL REGISTER NOTICE.—If an 

20 adjustment under subparagraph (A) or (B) is 

21 made, the rationale for the amount of the in22 crease or decrease (as applicable) in fee revenue 

23 and fees shall be contained in the annual Fed24 eral Register notice under paragraph (5) estabVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00075 Fmt 6652 Sfmt 6401 E:\BILLS\S934.RS S934

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1 lishing fee revenue and fees for the fiscal year 

2 involved. 

3 ‘‘(4) FISCAL YEAR 2018 ADJUSTMENT.— 

4 ‘‘(A) IN GENERAL.—For fiscal year 2018, 

5 the Secretary shall adjust the fee revenue and 

6 fees under this section in such amount (if any) 

7 as needed to reflect an updated assessment of 

8 the workload for the process for the review of 

9 biosimilar biological product applications. 

10 ‘‘(B) METHODOLOGY.—The Secretary shall 

11 publish under paragraph (5) a description of 

12 the methodology used to calculate the fiscal 

13 year 2018 adjustment under this paragraph in 

14 the Federal Register notice establishing fee rev15 enue and fees for fiscal year 2018. 

16 ‘‘(C) LIMITATION.—No adjustment under 

17 this paragraph shall result in an increase in fee 

18 revenue and fees under this section in excess of 

19 $9,000,000. 

20 ‘‘(5) ANNUAL FEE SETTING.—For fiscal year 

21 2018 and each subsequent fiscal year, the Secretary 

22 shall, not later than 60 days before the start of each 

23 such fiscal year— 

24 ‘‘(A) establish, for the fiscal year, initial 

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1 opment fees and reactivation fees under sub2 section (a)(1), biosimilar biological product ap3 plication fees under subsection (a)(2), and bio4 similar biological product program fees under 

5 subsection (a)(3), based on the revenue 

6 amounts established under subsection (b) and 

7 the adjustments provided under this subsection; 

8 and 

9 ‘‘(B) publish such fee revenue and fees in 

10 the Federal Register. 

11 ‘‘(6) LIMIT.—The total amount of fees assessed 

12 for a fiscal year under this section may not exceed 

13 the total costs for such fiscal year for the resources 

14 allocated for the process for the review of biosimilar 

15 biological product applications.’’. 

16 (d) APPLICATION FEE WAIVER FOR SMALL BUSI17 NESS.—Subsection (d)(1) of section 744H of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as 

19 redesignated by subsection (c)(1), is amended— 

20 (1) by striking subparagraph (B); 

21 (2) by striking ‘‘shall pay—’’ and all that fol22 lows through ‘‘application fees’’ and inserting ‘‘shall 

23 pay application fees’’; and 

24 (3) by striking ‘‘; and’’ at the end and inserting 

25 a period. 


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1 (e) EFFECT OF FAILURE TO PAY FEES.—Subsection 

2 (e) of section 744H of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379j–52), as redesignated by sub4 section (c)(1), is amended by striking ‘‘all fees’’ and in5 serting ‘‘all such fees’’. 

6 (f) CREDITING AND AVAILABILITY OF FEES.—Sub7 section (f) of section 744H of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 379j–52), as redesignated 

9 by subsection (c)(1), is amended— 

10 (1) in paragraph (2)— 

11 (A) by striking subparagraph (C) (relating 

12 to fee collection during first program year) and 

13 inserting the following: 

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

15 be considered to have met the requirements of 

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

17 described in such subparagraph are not more 

18 than 15 percent below the level specified in 

19 such subparagraph.’’; and 

20 (B) in subparagraph (D)— 

21 (i) in the heading, by striking ‘‘IN

22 SUBSEQUENT YEARS’’; and 

23 (ii) by striking ‘‘(after fiscal year 

24 2013)’’; and 


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1 (2) in paragraph (3), by striking ‘‘2013 

2 through 2017’’ and inserting ‘‘2018 through 2022’’. 

3 SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 

4 Section 744I of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 379j–53) is amended— 

6 (1) in subsection (a)— 

7 (A) by striking ‘‘2013’’ and inserting 

8 ‘‘2018’’; and 

9 (B) by striking ‘‘Biosimilar User Fee Act 

10 of 2012’’ and inserting ‘‘Biosimilar User Fee 

11 Amendments of 2017’’; 

12 (2) in subsection (b), by striking ‘‘2013’’ and 

13 inserting ‘‘2018’’; 

14 (3) by striking subsection (d); 

15 (4) by redesignating subsection (e) as sub16 section (d); and 

17 (5) in subsection (d), as so redesignated, by 

18 striking ‘‘2017’’ each place it appears and inserting 

19 ‘‘2022’’. 

20 SEC. 405. SUNSET DATES. 

21 (a) AUTHORIZATION.—Sections 744G and 744H of 

22 the Federal Food, Drug, and Cosmetic Act, as amended 

23 by section 403 of this Act, shall cease to be effective Octo24 ber 1, 2022. 


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1 (b) REPORTING REQUIREMENTS.—Section 744I of 

2 the Federal Food, Drug, and Cosmetic Act, as amended 

3 by section 404 of this Act, shall cease to be effective Janu4 ary 31, 2023. 

5 (c) PREVIOUS SUNSET PROVISION.— 

6 (1) IN GENERAL.—Effective October 1, 2017, 

7 section 404 of the Food and Drug Administration 

8 Safety and Innovation Act (Public Law 112–144) is 

9 repealed. 

10 (2) CONFORMING AMENDMENT.—The Food and 

11 Drug Administration Safety and Innovation Act 

12 (Public Law 112–144) is amended in the table of 

13 contents in section 2 by striking the item relating to 

14 section 404. 

15 SEC. 406. EFFECTIVE DATE. 

16 The amendments made by this title shall take effect 

17 on October 1, 2017, or the date of the enactment of this 

18 Act, whichever is later, except that fees under part 8 of 

19 subchapter C of chapter VII of the Federal Food, Drug, 

20 and Cosmetic Act shall be assessed for all biosimilar bio21 logical product applications received on or after October 

22 1, 2017, regardless of the date of the enactment of this 

23 Act. 


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1 SEC. 407. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

3 part 8 of subchapter C of chapter VII of the Federal Food, 

4 Drug, and Cosmetic Act, as in effect on the day before 

5 the date of the enactment of this title, shall continue to 

6 be in effect with respect to biosimilar biological product 

7 applications and supplements (as defined in such part as 

8 of such day) that were accepted by the Food and Drug 

9 Administration for filing on or after October 1, 2012, but 

10 before October 1, 2017, with respect to assessing and col11 lecting any fee required by such part for a fiscal year prior 

12 to fiscal year 2018. 

13 TITLE V—REAUTHORIZATION OF 

14 OTHER PROGRAMS 

15 SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO 

16 EXCLUSIVITY OF CERTAIN DRUGS CON17 TAINING SINGLE ENANTIOMERS. 

18 Section 505(u)(4) of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by strik20 ing ‘‘2017’’ and inserting ‘‘2022’’. 

21 SEC. 502. REAUTHORIZATION OF PEDIATRIC HUMANI22 TARIAN DEVICE EXCEPTIONS. 

23 Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

25 amended by striking ‘‘2017’’ and inserting ‘‘2022’’. 


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1 SEC. 503. REAUTHORIZATION OF THE CRITICAL PATH PUB2 LIC-PRIVATE PARTNERSHIPS. 

3 Section 566(f) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 

5 ‘‘2013 through 2017’’ and inserting ‘‘2018 through 

6 2022’’. 

7 SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE CON8 SORTIA. 

9 Section 305(e) of Pediatric Medical Device Safety 

10 and Improvement Act of 2007 (Public Law 110–85; 42 

11 U.S.C. 282 note) is amended by striking ‘‘2013 through 

12 2017’’ and inserting ‘‘2018 through 2022’’. 

13 SEC. 505. REAUTHORIZATION OF ORPHAN GRANTS PRO14 GRAM. 

15 Section 5(c) of the Orphan Drug Act (21 U.S.C. 

16 360ee(c)) is amended by striking ‘‘2013 through 2017’’ 

17 and inserting ‘‘2018 through 2022’’. 

18 SECTION 1. SHORT TITLE. 

19 This Act may be cited as the ‘‘FDA Reauthorization 

20 Act of 2017’’. 

21 SEC. 2. TABLE OF CONTENTS. 

22 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—FEES RELATING TO DRUGS 

Sec. 101. Short title; finding. 

Sec. 102. Authority to assess and use drug fees. 

Sec. 103. Reauthorization; reporting requirements. 


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Sec. 104. Sunset dates. 

Sec. 105. Effective date. 

Sec. 106. Savings clause. 

TITLE II—FEES RELATING TO DEVICES 

Sec. 201. Short title; findings. 

Sec. 202. Definitions. 

Sec. 203. Authority to assess and use device fees. 

Sec. 204. Reauthorization; reporting requirements. 

Sec. 205. Conformity assessment pilot program. 

Sec. 206. Reauthorization of review. 

Sec. 207. Electronic format for submissions. 

Sec. 208. Savings clause. 

Sec. 209. Effective date. 

Sec. 210. Sunset clause. 

TITLE III—FEES RELATING TO GENERIC DRUGS 

Sec. 301. Short title; finding. 

Sec. 302. Definitions. 

Sec. 303. Authority to assess and use human generic drug fees. 

Sec. 304. Reauthorization; reporting requirements. 

Sec. 305. Sunset dates. 

Sec. 306. Effective date. 

Sec. 307. Savings clause. 

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS 

Sec. 401. Short title; finding. 

Sec. 402. Definitions. 

Sec. 403. Authority to assess and use biosimilar fees. 

Sec. 404. Reauthorization; reporting requirements. 

Sec. 405. Sunset dates. 

Sec. 406. Effective date. 

Sec. 407. Savings clause. 

TITLE V—PEDIATRIC DRUGS AND DEVICES 

Sec. 501. Pediatric devices. 

Sec. 502. Pediatric drug development. 

Sec. 503. Guidance on molecular targets in pediatric oncology. 

Sec. 504. Best pharmaceuticals for children. 

TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO 

DRUGS 

Sec. 601. Reauthorization of provision relating to exclusivity of certain drugs 

containing single enantiomers. 

Sec. 602. Reauthorization of the critical path public-private partnerships. 

Sec. 603. Reauthorization of orphan grants program. 

Sec. 604. Guidance regarding bioequivalence. 

Sec. 605. Patient experience data. 

Sec. 606. Communications plans. 

Sec. 607. Protecting and strengthening the drug supply chain. 

Sec. 608. Technical corrections. 


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TITLE VII—DEVICE INSPECTION AND REGULATORY IMPROVEMENTS 

Sec. 701. Risk-based inspections for devices. 

Sec. 702. Improvements to inspections process. 

Sec. 703. Reauthorization of inspection program. 

Sec. 704. Certificates to foreign governments for devices. 

Sec. 705. Facilitating international harmonization. 

Sec. 706. Notification of guidance related to lab-developed tests. 

Sec. 707. Diagnostic imaging devices intended for use with contrast agents. 

Sec. 708. Diagnostic clarity. 

Sec. 709. Appropriate classification of device accessories. 

Sec. 710. Device pilot projects. 

Sec. 711. Regulation of over-the-counter hearing aids. 

TITLE VIII—ADDITIONAL PROVISIONS 

Sec. 801. GAO report. 

Sec. 802. Streamlining and improving consistency in performance reporting. 

Sec. 803. Analysis of use of funds. 

Sec. 804. Information on technology contracting. 

Sec. 805. Facilities management. 

Sec. 806. Expanded access. 

Sec. 807. Technical corrections. 

TITLE IX—GENERIC DRUG ACCESS 

Subtitle A—Removing Regulatory Barriers to Competition 

Sec. 901. Improving access to generic drugs. 

Sec. 902. Reporting on pending generic drug applications, priority review applications, and inspections. 

Subtitle B—Incentivizing Competition 

Sec. 911. Expediting generic competition. 

Sec. 912. List of generic drugs with limited competition. 

Sec. 913. Suitability petitions. 

Sec. 914. Inspections. 

1 TITLE I—FEES RELATING TO 

2 DRUGS 

3 SEC. 101. SHORT TITLE; FINDING. 

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

5 ‘‘Prescription Drug User Fee Amendments of 2017’’. 

6 (b) FINDING.—The Congress finds that the fees author7 ized by the amendments made in this title will be dedicated 

8 toward expediting the drug development process and the 


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1 process for the review of human drug applications, includ2 ing postmarket drug safety activities, as set forth in the 

3 goals identified for purposes of part 2 of subchapter C of 

4 chapter VII of the Federal Food, Drug, and Cosmetic Act, 

5 in the letters from the Secretary of Health and Human 

6 Services to the Chairman of the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate and the Chair8 man of the Committee on Energy and Commerce of the 

9 House of Representatives, as set forth in the Congressional 

10 Record. 

11 SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES. 

12 (a) TYPES OF FEES.— 

13 (1) IN GENERAL.—Section 736(a) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is 

15 amended— 

16 (A) in the matter preceding paragraph (1), 

17 by striking ‘‘fiscal year 2013’’ and inserting ‘‘fis18 cal year 2018’’; 

19 (B) in the heading of paragraph (1), by 

20 striking ‘‘AND SUPPLEMENT’’; 

21 (C) in paragraph (1), by striking ‘‘or a 

22 supplement’’ and ‘‘or supplement’’ each place ei23 ther appears; 

24 (D) in paragraph (1)(A)— 


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1 (i) in clause (i), by striking ‘‘(c)(4)’’ 

2 and inserting ‘‘(c)(5)’’; and 

3 (ii) in clause (ii), by striking ‘‘A fee 

4 established’’ and all that follows through 

5 ‘‘are required.’’ and inserting the following: 

6 ‘‘A fee established under subsection (c)(5) 

7 for a human drug application for which 

8 clinical data (other than bioavailability or 

9 bioequivalence studies) with respect to safety 

10 or effectiveness are not required for ap11 proval.’’; 

12 (E) in the heading of paragraph (1)(C), by 

13 striking ‘‘OR SUPPLEMENT’’; 

14 (F) in paragraph (1)(F)— 

15 (i) in the heading, by striking ‘‘OR IN16 DICATION’’; and 

17 (ii) by striking the second sentence; 

18 (G) by striking paragraph (2) (relating to 

19 a prescription drug establishment fee); 

20 (H) by redesignating paragraph (3) as 

21 paragraph (2); 

22 (I) in the heading of paragraph (2), as so 

23 redesignated, by striking ‘‘PRESCRIPTION DRUG

24 PRODUCT FEE’’ and inserting ‘‘PRESCRIPTION

25 DRUG PROGRAM FEE’’; 


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1 (J) in subparagraph (A) of such paragraph 

2 (2), by amending the first sentence to read as fol3 lows: ‘‘Except as provided in subparagraphs (B) 

4 and (C), each person who is named as the appli5 cant in a human drug application, and who, 

6 after September 1, 1992, had pending before the 

7 Secretary a human drug application or supple8 ment, shall pay the annual prescription drug 

9 program fee established for a fiscal year under 

10 subsection (c)(5) for each prescription drug prod11 uct that is identified in such a human drug ap12 plication approved as of October 1 of such fiscal 

13 year.’’; 

14 (K) in subparagraph (B) of such paragraph 

15 (2)— 

16 (i) in the heading of subparagraph 

17 (B), by inserting after ‘‘EXCEPTION’’ the fol18 lowing: ‘‘FOR CERTAIN PRESCRIPTION DRUG

19 PRODUCTS’’; and 

20 (ii) by striking ‘‘A prescription drug 

21 product shall not be assessed a fee’’ and in22 serting ‘‘A prescription drug program fee 

23 shall not be assessed for a prescription drug 

24 product’’; and 


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1 (L) by adding at the end of such paragraph 

2 (2) the following: 

3 ‘‘(C) LIMITATION.—A person who is named 

4 as the applicant in an approved human drug 

5 application shall not be assessed more than 5 

6 prescription drug program fees for a fiscal year 

7 for prescription drug products identified in such 

8 approved human drug application.’’. 

9 (2) CONFORMING AMENDMENT.—Subparagraph 

10 (C) of section 740(a)(3) of the Federal Food, Drug, 

11 and Cosmetic Act (21 U.S.C. 379j–12(a)(3)) is 

12 amended to read as follows: 

13 ‘‘(C) LIMITATION.—An establishment shall 

14 be assessed only one fee per fiscal year under this 

15 section.’’. 

16 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec17 tion 736 of the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 379h) is amended to read as follows: 

19 ‘‘(b) FEE REVENUE AMOUNTS.— 

20 ‘‘(1) IN GENERAL.—For each of the fiscal years 

21 2018 through 2022, fees under subsection (a) shall, ex22 cept as provided in subsections (c), (d), (f), and (g), 

23 be established to generate a total revenue amount 

24 under such subsection that is equal to the sum of— 


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

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

3 ‘‘(B) the dollar amount equal to the infla4 tion adjustment for the fiscal year (as deter5 mined under subsection (c)(1)); 

6 ‘‘(C) the dollar amount equal to the capac7 ity planning adjustment for the fiscal year (as 

8 determined under subsection (c)(2)); 

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

11 applicable (as determined under subsection 

12 (c)(3)); 

13 ‘‘(E) the dollar amount equal to the addi14 tional direct cost adjustment for the fiscal year 

15 (as determined under subsection (c)(4)); and 

16 ‘‘(F) additional dollar amounts for each fis17 cal year as follows: 

18 ‘‘(i) $20,077,793 for fiscal year 2018; 

19 ‘‘(ii) $21,317,472 for fiscal year 2019; 

20 ‘‘(iii) $16,953,329 for fiscal year 2020; 

21 ‘‘(iv) $5,426,896 for fiscal year 2021; 

22 and 

23 ‘‘(v) $2,769,609 for fiscal year 2022. 


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1 ‘‘(2) TYPES OF FEES.—Of the total revenue 

2 amount determined for a fiscal year under paragraph 

3 (1)— 

4 ‘‘(A) 20 percent shall be derived from 

5 human drug application fees under subsection 

6 (a)(1); and 

7 ‘‘(B) 80 percent shall be derived from pre8 scription drug program fees under subsection 

9 (a)(2). 

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

11 paragraph (1), the dollar amount of the annual base 

12 revenue for a fiscal year shall be— 

13 ‘‘(A) for fiscal year 2018, $878,590,000; and 

14 ‘‘(B) for fiscal years 2019 through 2022, the 

15 dollar amount of the total revenue amount estab16 lished under paragraph (1) for the previous fis17 cal year, not including any adjustments made 

18 under subsection (c)(3) or (c)(4).’’. 

19 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Sub20 section (c) of section 736 of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 379h) is amended to read as fol22 lows: 

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

24 ‘‘(1) INFLATION ADJUSTMENT.— 


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1 ‘‘(A) IN GENERAL.—For purposes of sub2 section (b)(1)(B), the dollar amount of the infla3 tion adjustment to the annual base revenue for 

4 each fiscal year shall be equal to the product 

5 of— 

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

7 fiscal year under subsection (b)(1)(A); 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 the sum of— 

14 ‘‘(i) the average annual percent change 

15 in the cost, per full-time equivalent position 

16 of the Food and Drug Administration, of all 

17 personnel compensation and benefits paid 

18 with respect to such positions for the first 3 

19 years of the preceding 4 fiscal years, multi20 plied by the proportion of personnel com21 pensation and benefits costs to total costs of 

22 the process for the review of human drug 

23 applications (as defined in section 735(6)) 

24 for the first 3 years of the preceding 4 fiscal 

25 years; and 


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1 ‘‘(ii) the average annual percent 

2 change that occurred in the Consumer Price 

3 Index for urban consumers (Washington4 Baltimore, DC–MD–VA–WV; Not Season5 ally Adjusted; All items; Annual Index) for 

6 the first 3 years of the preceding 4 years of 

7 available data multiplied by the proportion 

8 of all costs other than personnel compensa9 tion and benefits costs to total costs of the 

10 process for the review of human drug appli11 cations (as defined in section 735(6)) for the 

12 first 3 years of the preceding 4 fiscal years. 

13 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

14 ‘‘(A) IN GENERAL.—For each fiscal year, 

15 after the annual base revenue established in sub16 section (b)(1)(A) is adjusted for inflation in ac17 cordance with paragraph (1), such revenue shall 

18 be adjusted further for such fiscal year, in ac19 cordance with this paragraph, to reflect changes 

20 in the resource capacity needs of the Secretary 

21 for the process for the review of human drug ap22 plications. 

23 ‘‘(B) INTERIM METHODOLOGY.— 

24 ‘‘(i) IN GENERAL.—Until the capacity 

25 planning methodology described in subparaVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00092 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 graph (C) is effective, the adjustment under 

2 this paragraph for a fiscal year shall be 

3 based on the product of— 

4 ‘‘(I) the annual base revenue for 

5 such year, as adjusted for inflation 

6 under paragraph (1); and 

7 ‘‘(II) the adjustment percentage 

8 under clause (ii). 

9 ‘‘(ii) ADJUSTMENT PERCENTAGE.—The 

10 adjustment percentage under this clause for 

11 a fiscal year is the weighted change in the 

12 3-year average ending in the most recent 

13 year for which data are available, over the 

14 3-year average ending in the previous year, 

15 for— 

16 ‘‘(I) the total number of human 

17 drug applications, efficacy supple18 ments, and manufacturing supple19 ments submitted to the Secretary; 

20 ‘‘(II) the total number of active 

21 commercial investigational new drug 

22 applications; and 

23 ‘‘(III) the total number of formal 

24 meetings scheduled by the Secretary, 

25 and written responses issued by the 


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1 Secretary in lieu of such formal meet2 ings, as identified in section I.H of the 

3 letters described in section 101(b) of the 

4 Prescription Drug User Fee Amend5 ments of 2017. 

6 ‘‘(C) CAPACITY PLANNING METHODOLOGY.— 

7 ‘‘(i) DEVELOPMENT; EVALUATION AND

8 REPORT.—The Secretary shall obtain, 

9 through a contract with an independent ac10 counting or consulting firm, a report evalu11 ating options and recommendations for a 

12 new methodology to accurately assess 

13 changes in the resource and capacity needs 

14 of the process for the review of human drug 

15 applications. The capacity planning meth16 odological options and recommendations 

17 presented in such report shall utilize and be 

18 informed by personnel time reporting data 

19 as an input. The report shall be published 

20 for public comment no later than the end of 

21 fiscal year 2020. 

22 ‘‘(ii) ESTABLISHMENT AND IMPLEMEN23 TATION.—After review of the report de24 scribed in clause (i) and any public com25 ments thereon, the Secretary shall establish 


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1 a capacity planning methodology for pur2 poses of this paragraph, which shall— 

3 ‘‘(I) replace the interim method4 ology under subparagraph (B); 

5 ‘‘(II) incorporate such approaches 

6 and attributes as the Secretary deter7 mines appropriate; and 

8 ‘‘(III) be effective beginning with 

9 the first fiscal year for which fees are 

10 set after such capacity planning meth11 odology is established. 

12 ‘‘(D) LIMITATION.—Under no circumstances 

13 shall an adjustment under this paragraph result 

14 in fee revenue for a fiscal year that is less than 

15 the sum of the amounts under subsections 

16 (b)(1)(A) (the annual base revenue for the fiscal 

17 year) and (b)(1)(B) (the dollar amount of the in18 flation adjustment for the fiscal year). 

19 ‘‘(E) PUBLICATION IN FEDERAL REG20 ISTER.—The Secretary shall publish in the Fed21 eral Register notice under paragraph (5) the fee 

22 revenue and fees resulting from the adjustment 

23 and the methodologies under this paragraph. 

24 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 


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1 ‘‘(A) INCREASE.—For fiscal year 2018 and 

2 subsequent fiscal years, the Secretary may, in 

3 addition to adjustments under paragraphs (1) 

4 and (2), further increase the fee revenue and fees 

5 if such an adjustment is necessary to provide for 

6 not more than 14 weeks of operating reserves of 

7 carryover user fees for the process for the review 

8 of human drug applications. 

9 ‘‘(B) DECREASE.—If the Secretary has car10 ryover balances for such process in excess of 14 

11 weeks of such operating reserves, the Secretary 

12 shall decrease such fee revenue and fees to pro13 vide for not more than 14 weeks of such oper14 ating reserves. 

15 ‘‘(C) NOTICE OF RATIONALE.—If an adjust16 ment under subparagraph (A) or (B) is made, 

17 the rationale for the amount of the increase or 

18 decrease (as applicable) in fee revenue and fees 

19 shall be contained in the annual Federal Reg20 ister notice under paragraph (5) establishing fee 

21 revenue and fees for the fiscal year involved. 

22 ‘‘(4) ADDITIONAL DIRECT COST ADJUSTMENT.— 

23 ‘‘(A) IN GENERAL.—The Secretary shall, in 

24 addition to adjustments under paragraphs (1), 


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1 (2), and (3), further increase the fee revenue and 

2 fees— 

3 ‘‘(i) for fiscal year 2018, by 

4 $8,730,000; and 

5 ‘‘(ii) for fiscal year 2019 and subse6 quent fiscal years, by the amount deter7 mined under subparagraph (B). 

8 ‘‘(B) AMOUNT.—The amount determined 

9 under this subparagraph is— 

10 ‘‘(i) $8,730,000, multiplied by 

11 ‘‘(ii) the Consumer Price Index for 

12 urban consumers (Washington-Baltimore, 

13 DC–MD–VA–WV; Not Seasonally Adjusted; 

14 All Items; Annual Index) for the most re15 cent year of available data, divided by such 

16 Index for 2016. 

17 ‘‘(5) ANNUAL FEE SETTING.—The Secretary 

18 shall, not later than 60 days before the start of each 

19 fiscal year that begins after September 30, 2017— 

20 ‘‘(A) establish, for the next fiscal year, 

21 human drug application fees and prescription 

22 drug program fees under subsection (a), based on 

23 the revenue amounts established under subsection 

24 (b) and the adjustments provided under this sub25 section; and 


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1 ‘‘(B) publish such fee revenue and fees in 

2 the Federal Register. 

3 ‘‘(6) LIMIT.—The total amount of fees charged, 

4 as adjusted under this subsection, for a fiscal year 

5 may not exceed the total costs for such fiscal year for 

6 the resources allocated for the process for the review 

7 of human drug applications.’’. 

8 (d) FEE WAIVER OR REDUCTION.—Section 736(d) of 

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

10 379h(d)) is amended— 

11 (1) in paragraph (1)— 

12 (A) by inserting ‘‘or’’ at the end of subpara13 graph (B); 

14 (B) by striking subparagraph (C); and 

15 (C) by redesignating subparagraph (D) as 

16 subparagraph (C); 

17 (2) by striking paragraph (3) (relating to use of 

18 standard costs); 

19 (3) by redesignating paragraph (4) as para20 graph (3); and 

21 (4) in paragraph (3), as so redesignated— 

22 (A) in subparagraphs (A) and (B), by strik23 ing ‘‘paragraph (1)(D)’’ and inserting ‘‘para24 graph (1)(C)’’; and 

25 (B) in subparagraph (B)— 


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1 (i) by striking clause (ii); 

2 (ii) by striking ‘‘shall pay’’ through 

3 ‘‘(i) application fees’’ and inserting ‘‘shall 

4 pay application fees’’; and 

5 (iii) by striking ‘‘; and’’ at the end 

6 and inserting a period. 

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

8 736(e) of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 379h(e)) is amended by striking ‘‘all fees’’ and in10 serting ‘‘all such fees’’. 

11 (f) LIMITATIONS.—Section 736(f)(2) of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is 

13 amended by striking ‘‘supplements, prescription drug estab14 lishments, and prescription drug products’’ and inserting 

15 ‘‘prescription drug program fees’’. 

16 (g) CREDITING AND AVAILABILITY OF FEES.—Section 

17 736(g) of the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 379h(g)) is amended— 

19 (1) in paragraph (3)— 

20 (A) by striking ‘‘2013 through 2017’’ and 

21 inserting ‘‘2018 through 2022’’; and 

22 (B) by striking ‘‘and paragraph (4) of this 

23 subsection’’; and 

24 (2) by striking paragraph (4). 


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1 (h) ORPHAN DRUGS.—Section 736(k) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is 

3 amended by striking ‘‘product and establishment fees’’ each 

4 place it appears and inserting ‘‘prescription drug program 

5 fees’’. 

6 SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 

7 Section 736B of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 379h–2) is amended— 

9 (1) in subsection (a)(1)— 

10 (A) in the matter before subparagraph (A), 

11 by striking ‘‘2013’’ and inserting ‘‘2018’’; and 

12 (B) in subparagraph (A), by striking ‘‘Pre13 scription Drug User Fee Amendments of 2012’’ 

14 and inserting ‘‘Prescription Drug User Fee 

15 Amendments of 2017’’; 

16 (2) in subsection (b), by striking ‘‘2013’’ and in17 serting ‘‘2018’’; and 

18 (3) in subsection (d), by striking ‘‘2017’’ each 

19 place it appears and inserting ‘‘2022’’. 

20 SEC. 104. SUNSET DATES. 

21 (a) AUTHORIZATION.—Sections 735 and 736 of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 

23 379h) shall cease to be effective October 1, 2022. 


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1 (b) REPORTING REQUIREMENTS.—Section 736B of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h– 

3 2) shall cease to be effective January 31, 2023. 

4 (c) PREVIOUS SUNSET PROVISION.—Effective October 

5 1, 2017, subsections (a) and (b) of section 105 of the Food 

6 and Drug Administration Safety and Innovation Act (Pub7 lic Law 112–144) are repealed. 

8 SEC. 105. EFFECTIVE DATE. 

9 The amendments made by this title shall take effect 

10 on October 1, 2017, or the date of the enactment of this 

11 Act, whichever is later, except that fees under part 2 of sub12 chapter C of chapter VII of the Federal Food, Drug, and 

13 Cosmetic Act shall be assessed for all human drug applica14 tions received on or after October 1, 2017, regardless of the 

15 date of the enactment of this Act. 

16 SEC. 106. SAVINGS CLAUSE. 

17 Notwithstanding the amendments made by this title, 

18 part 2 of subchapter C of chapter VII of the Federal Food, 

19 Drug, and Cosmetic Act, as in effect on the day before the 

20 date of the enactment of this title, shall continue to be in 

21 effect with respect to human drug applications and supple22 ments (as defined in such part as of such day) that on or 

23 after October 1, 2012, but before October 1, 2017, were ac24 cepted by the Food and Drug Administration for filing with 


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1 respect to assessing and collecting any fee required by such 

2 part for a fiscal year prior to fiscal year 2018. 

3 TITLE II—FEES RELATING TO 

4 DEVICES 

5 SEC. 201. SHORT TITLE; FINDINGS. 

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

7 ‘‘Medical Device User Fee Amendments of 2017’’. 

8 (b) FINDINGS.—The Congress finds that the fees au9 thorized under the amendments made by this title will be 

10 dedicated toward expediting the process for the review of 

11 device applications and for assuring the safety and effec12 tiveness of devices, as set forth in the goals identified for 

13 purposes of part 3 of subchapter C of chapter VII of the 

14 Federal Food, Drug, and Cosmetic Act in the letters from 

15 the Secretary of Health and Human Services to the Chair16 man of the Committee on Health, Education, Labor, and 

17 Pensions of the Senate and the Chairman of the Committee 

18 on Energy and Commerce of the House of Representatives, 

19 as set forth in the Congressional Record. 

20 SEC. 202. DEFINITIONS. 

21 Section 737 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 379i) is amended— 

23 (1) by redesignating paragraphs (8) through (13) 

24 as paragraphs (9) through (14), respectively; 


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1 (2) by inserting after paragraph (7) the fol2 lowing new paragraph: 

3 ‘‘(8) The term ‘de novo classification request’ 

4 means a request made under section 513(f)(2)(A) with 

5 respect to the classification of a device.’’; 

6 (3) in subparagraph (D) of paragraph (10) (as 

7 redesignated by paragraph (1)), by striking ‘‘and sub8 missions’’ and inserting ‘‘submissions, and de novo 

9 classification requests’’; and 

10 (4) in paragraph (11) (as redesignated by para11 graph (1)), by striking ‘‘2011’’ and inserting ‘‘2016’’. 

12 SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 

13 (a) TYPES OF FEES.—Section 738(a) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 

15 amended— 

16 (1) in paragraph (1), by striking ‘‘fiscal year 

17 2013’’ and inserting ‘‘fiscal year 2018’’; and 

18 (2) in paragraph (2)— 

19 (A) in subparagraph (A)— 

20 (i) in the matter preceding clause (i), 

21 by striking ‘‘October 1, 2012’’ and inserting 

22 ‘‘October 1, 2017’’; 

23 (ii) in clause (viii), by striking ‘‘2’’ 

24 and inserting ‘‘3.4’’; and 


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1 (iii) by adding at the end the following 

2 new clause: 

3 ‘‘(xi) For a de novo classification re4 quest, a fee equal to 30 percent of the fee 

5 that applies under clause (i).’’; and 

6 (B) in subparagraph (B)(v)(I), by striking 

7 ‘‘or premarket notification submission’’ and in8 serting ‘‘premarket notification submission, or de 

9 novo classification request’’. 

10 (b) FEE AMOUNTS.—Section 738(b) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is 

12 amended to read as follows: 

13 ‘‘(b) FEE AMOUNTS.— 

14 ‘‘(1) IN GENERAL.—Subject to subsections (c), 

15 (d), (e), and (h), for each of fiscal years 2018 through 

16 2022, fees under subsection (a) shall be derived from 

17 the base fee amounts specified in paragraph (2), to 

18 generate the total revenue amounts specified in para19 graph (3). 

20 ‘‘(2) BASE FEE AMOUNTS SPECIFIED.—For pur21 poses of paragraph (1), the base fee amounts specified 

22 in this paragraph are as follows: 

‘‘Fee Type 

Fiscal 

Year 

2018 

Fiscal 

Year 

2019 

Fiscal 

Year 

2020 

Fiscal 

Year 

2021 

Fiscal 

Year 

2022 

Premarket Application ................................ $294,000 $300,000 $310,000 $328,000 $329,000 

Establishment Registration ......................... $4,375 $4,548 $4,760 $4,975 $4,978 


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1 ‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— 

2 For purposes of paragraph (1), the total revenue 

3 amounts specified in this paragraph are as follows: 

4 ‘‘(A) $183,280,756 for fiscal year 2018. 

5 ‘‘(B) $190,654,875 for fiscal year 2019. 

6 ‘‘(C) $200,132,014 for fiscal year 2020. 

7 ‘‘(D) $211,748,789 for fiscal year 2021. 

8 ‘‘(E) $213,687,660 for fiscal year 2022.’’. 

9 (c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 

10 738(c) of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 379j(c)) is amended— 

12 (1) in paragraph (1), by striking ‘‘2012’’ and in13 serting ‘‘2017’’; 

14 (2) in paragraph (2)— 

15 (A) in subparagraph (A), by striking 

16 ‘‘2014’’ and inserting ‘‘2018’’; 

17 (B) by striking subparagraph (B) and in18 serting the following new subparagraph: 

19 ‘‘(B) APPLICABLE INFLATION ADJUST20 MENT.—The applicable inflation adjustment for 

21 fiscal year 2018 and each subsequent fiscal year 

22 is the product of— 

23 ‘‘(i) the base inflation adjustment 

24 under subparagraph (C) for such fiscal 

25 year; and 


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1 ‘‘(ii) the product of the base inflation 

2 adjustment under subparagraph (C) for 

3 each of the fiscal years preceding such fiscal 

4 year, beginning with fiscal year 2016.’’; 

5 (C) in subparagraph (C), in the heading, by 

6 striking ‘‘TO TOTAL REVENUE AMOUNTS’’; and 

7 (D) by amending subparagraph (D) to read 

8 as follows: 

9 ‘‘(D) ADJUSTMENT TO BASE FEE

10 AMOUNTS.—For each of fiscal years 2018 

11 through 2022, the Secretary shall— 

12 ‘‘(i) adjust the base fee amounts speci13 fied in subsection (b)(2) for such fiscal year 

14 by multiplying such amounts by the appli15 cable inflation adjustment under subpara16 graph (B) for such year; and 

17 ‘‘(ii) if the Secretary determines nec18 essary, increase (in addition to the adjust19 ment under clause (i)) such base fee 

20 amounts, on a uniform proportionate basis, 

21 to generate the total revenue amounts under 

22 subsection (b)(3), as adjusted for inflation 

23 under subparagraph (A).’’; and 

24 (3) in paragraph (3)— 


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1 (A) by striking ‘‘2014 through 2017’’ and 

2 inserting ‘‘2018 through 2022’’; and 

3 (B) by striking ‘‘further adjusted’’ and in4 serting ‘‘increased’’. 

5 (d) SMALL BUSINESSES; FEE WAIVER AND FEE RE6 DUCTION REGARDING PREMARKET APPROVAL FEES.—Sec7 tion 738(d) of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 379j(d)) is amended— 

9 (1) in paragraph (1), by striking ‘‘specified in 

10 clauses (i) through (v) and clauses (vii), (ix), and 

11 (x)’’ and inserting ‘‘specified in clauses (i) through 

12 (vii) and clauses (ix), (x), and (xi)’’; and 

13 (2) in paragraph (2)(C)— 

14 (A) by striking ‘‘supplement, or’’ and in15 serting ‘‘supplement,’’; and 

16 (B) by inserting ‘‘, or a de novo classifica17 tion request’’ after ‘‘class III device’’. 

18 (e) SMALL BUSINESSES; FEE REDUCTION REGARDING

19 PREMARKET NOTIFICATION SUBMISSIONS.—Section 

20 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act 

21 (21 U.S.C. 379j(e)(2)(C)) is amended by striking ‘‘50’’ and 

22 inserting ‘‘25’’. 

23 (f) FEE WAIVER OR REDUCTION.— 


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1 (1) REPEAL.—Section 738 of the Federal Food, 

2 Drug, and Cosmetic Act (21 U.S.C. 379j) is amended 

3 by striking subsection (f). 

4 (2) CONFORMING CHANGES.— 

5 (A) Section 515(c)(4)(A) of the Federal 

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

7 360e(c)(4)(A)) is amended by striking ‘‘738(h)’’ 

8 and inserting ‘‘738(g)’’. 

9 (B) Section 738 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 379j), as amended 

11 by paragraph (1), is further amended— 

12 (i) by redesignating subsections (g) 

13 through (l) as subsections (f) through (k); 

14 (ii) in subsection (a)(2)(A), by striking 

15 ‘‘(d), (e), and (f)’’ and inserting ‘‘(d) and 

16 (e)’’; and 

17 (iii) in subsection (a)(3)(A), by strik18 ing ‘‘and subsection (f)’’. 

19 (g) EFFECT OF FAILURE TO PAY FEES.—Subsection 

20 (f)(1), as redesignated, of section 738 of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— 

22 (1) by striking ‘‘or periodic reporting concerning 

23 a class III device’’ and inserting ‘‘periodic reporting 

24 concerning a class III device, or de novo classification 

25 request’’; and 


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1 (2) by striking ‘‘all fees’’ and inserting ‘‘all such 

2 fees’’. 

3 (h) CONDITIONS.—Subsection (g)(1)(A), as redesig4 nated, of section 738 of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 379j) is amended by striking 

6 ‘‘$280,587,000’’ and inserting ‘‘$320,825,000’’. 

7 (i) CREDITING AND AVAILABILITY OF FEES.—Sub8 section (h), as redesignated, of section 738 of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend10 ed— 

11 (1) in paragraph (3)— 

12 (A) by striking ‘‘2013 through 2017’’ and 

13 inserting ‘‘2018 through 2022’’; and 

14 (B) by striking ‘‘subsection (c)’’ and all that 

15 follows through the period at the end and insert16 ing ‘‘subsection (c).’’; and 

17 (2) by striking paragraph (4). 

18 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

19 (a) PERFORMANCE REPORTS.—Section 738A(a) of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

21 1(a)) is amended— 

22 (1) in paragraph (1)— 

23 (A) in subparagraph (A)— 

24 (i) by striking ‘‘2013’’ and inserting 

25 ‘‘2018’’; and 


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1 (ii) by striking ‘‘the Medical Device 

2 User Fee Amendments of 2012’’ and insert3 ing ‘‘Medical Device User Fee Amendments 

4 of 2017’’; and 

5 (B) in subparagraph (B), by striking ‘‘the 

6 Medical Device User Fee Amendments of 2012’’ 

7 and inserting ‘‘Medical Device User Fee Amend8 ments of 2017’’; and 

9 (2) in paragraph (2), by striking ‘‘2013 through 

10 2017’’ and inserting ‘‘2018 through 2022’’. 

11 (b) REAUTHORIZATION.—Section 738A(b) of the Fed12 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) 

13 is amended— 

14 (1) in paragraph (1), by striking ‘‘2017’’ and in15 serting ‘‘2022’’; and 

16 (2) in paragraph (5), by striking ‘‘2017’’ and in17 serting ‘‘2022’’. 

18 SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 

19 (a) IN GENERAL.—Section 514 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360d) is amended by 

21 adding at the end the following: 

22 ‘‘(d) PILOT ACCREDITATION SCHEME FOR CON23 FORMITY ASSESSMENT.— 

24 ‘‘(1) IN GENERAL.—The Secretary shall establish 

25 a pilot program under which— 


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1 ‘‘(A) testing laboratories may be accredited, 

2 by accreditation bodies meeting criteria specified 

3 by the Secretary, to assess the conformance of a 

4 device with certain standards recognized under 

5 this section; and 

6 ‘‘(B) subject to paragraph (2), determina7 tions by testing laboratories so accredited that a 

8 device conforms with such standard or standards 

9 shall be accepted by the Secretary for purposes of 

10 demonstrating such conformity under this sec11 tion unless the Secretary finds that a particular 

12 such determination shall not be so accepted. 

13 ‘‘(2) SECRETARIAL REVIEW OF ACCREDITED LAB14 ORATORY DETERMINATIONS.—The Secretary may— 

15 ‘‘(A) review determinations by testing lab16 oratories accredited pursuant to this subsection, 

17 including by conducting periodic audits of such 

18 determinations or processes of accredited bodies 

19 or testing laboratories and, following such re20 view, taking additional measures under this Act, 

21 such as suspension or withdrawal of accredita22 tion of such testing laboratory under paragraph 

23 (1)(A) or requesting additional information with 

24 respect to such device, as the Secretary deter25 mines appropriate; and 


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1 ‘‘(B) if the Secretary becomes aware of in2 formation materially bearing on safety or effec3 tiveness of a device assessed for conformity by a 

4 testing laboratory so accredited, take such addi5 tional measures under this Act as the Secretary 

6 determines appropriate, such as suspension or 

7 withdrawal of accreditation of such testing lab8 oratory under paragraph (1)(A), or requesting 

9 additional information with regard to such de10 vice. 

11 ‘‘(3) IMPLEMENTATION AND REPORTING.— 

12 ‘‘(A) PUBLIC MEETING.—The Secretary 

13 shall publish in the Federal Register a notice of 

14 a public meeting to be held no later than Sep15 tember 30, 2018, to discuss and obtain input 

16 and recommendations from stakeholders regard17 ing the goals and scope of, and a suitable frame18 work and procedures and requirements for, the 

19 pilot program under this subsection. 

20 ‘‘(B) PILOT PROGRAM GUIDANCE.—The Sec21 retary shall— 

22 ‘‘(i) not later than September 30, 2019, 

23 issue draft guidance regarding the goals 

24 and implementation of the pilot program 

25 under this subsection; and 


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1 ‘‘(ii) not later than September 30, 

2 2021, issue final guidance with respect to 

3 the implementation of such program. 

4 ‘‘(C) PILOT PROGRAM INITIATION.—Not 

5 later than September 30, 2020, the Secretary 

6 shall initiate the pilot program under this sub7 section. 

8 ‘‘(D) REPORT.—The Secretary shall make 

9 available on the website of the Food and Drug 

10 Administration an annual report on the progress 

11 of the pilot program under this subsection. 

12 ‘‘(4) SUNSET.—As of October 1, 2022— 

13 ‘‘(A) the authority for accreditation bodies 

14 to accredit testing laboratories pursuant to para15 graph (1)(A) shall cease to have force or effect; 

16 ‘‘(B) the Secretary— 

17 ‘‘(i) may not accept a determination 

18 pursuant to paragraph (1)(B) made by a 

19 testing laboratory after such date; and 

20 ‘‘(ii) may accept such a determination 

21 made prior to such date; 

22 ‘‘(C) except for purposes of accepting a de23 termination described in subparagraph (B)(ii), 

24 the Secretary shall not continue to recognize the 


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1 accreditation of testing laboratories accredited 

2 under paragraph (1)(A); and 

3 ‘‘(D) the Secretary may take actions in ac4 cordance with paragraph (2) with respect to the 

5 determinations made prior to such date and rec6 ognition of the accreditation of testing labora7 tories pursuant to determinations made prior to 

8 such date.’’. 

9 SEC. 206. REAUTHORIZATION OF REVIEW. 

10 Section 523 of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 360m) is amended— 

12 (1) in subsection (a)(3)— 

13 (A) in subparagraph (A), by striking 

14 clauses (ii) and (iii) and inserting the following: 

15 ‘‘(ii) a device classified under section 

16 513(f)(2) or designated under section 

17 515C(d); 

18 ‘‘(iii) a device that is intended to be 

19 life sustaining or life supporting, unless 

20 otherwise determined by the Secretary in 

21 accordance with subparagraph (B)(i)(II) 

22 and listed as eligible for review under sub23 paragraph (B)(iii); or 


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1 ‘‘(iv) a device that is of a type, or sub2 set of a type, listed as not eligible for review 

3 under subparagraph (B)(iii).’’; 

4 (B) by striking subparagraph (B) and in5 serting the following: 

6 ‘‘(B) DESIGNATION FOR REVIEW.—The Sec7 retary shall— 

8 ‘‘(i) issue draft guidance on the factors 

9 the Secretary will use in determining 

10 whether a class I or class II device type, or 

11 subset of such device types, is eligible for re12 view by an accredited person, including— 

13 ‘‘(I) the risk of the device type, or 

14 subset of such device type; and 

15 ‘‘(II) whether the device type, or 

16 subset of such device type, is perma17 nently implantable, life sustaining, or 

18 life supporting, and whether there is a 

19 detailed public health justification for 

20 permitting the review by an accredited 

21 person of a specific life sustaining or 

22 life supporting device; 

23 ‘‘(ii) not later than 24 months after the 

24 date on which the Secretary issues such 

25 draft guidance, finalize such guidance; and 


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1 ‘‘(iii) beginning on the date such guid2 ance is finalized, designate and post on the 

3 Internet website of the Food and Drug Ad4 ministration, an updated list of class I and 

5 class II device types, or subsets of such de6 vice types, and the Secretary’s determina7 tion with respect to whether each such de8 vice type, or subset of a device type, is eligi9 ble or not eligible for review by an accred10 ited person under this section based on the 

11 factors described in clause (i).’’; and 

12 (C) by adding at the end the following: 

13 ‘‘(C) INTERIM RULE.—Until the date on 

14 which the updated list is designated and posted 

15 in accordance with subparagraph (B)(iii), the 

16 list in effect on the date of enactment the Medical 

17 Device User Fee Amendments of 2017 shall be in 

18 effect.’’; 

19 (2) in subsection (b)— 

20 (A) in paragraph (2)— 

21 (i) by striking subparagraph (D); and 

22 (ii) by redesignating subparagraph (E) 

23 as subparagraph (D); and 

24 (B) in paragraph (3)— 


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1 (i) by redesignating subparagraph (E) 

2 as subparagraph (F); 

3 (ii) in subparagraph (F) (as so redes4 ignated), by striking ‘‘The operations of’’ 

5 and all that follows through ‘‘it will—’’ and 

6 inserting ‘‘Such person shall agree, at a 

7 minimum, to include in its request for ac8 creditation a commitment to, at the time of 

9 accreditation, and at any time it is per10 forming any review pursuant to this sec11 tion—’’; and 

12 (iii) by inserting after subparagraph 

13 (D) the following new subparagraph: 

14 ‘‘(E) The operations of such person shall be 

15 in accordance with generally accepted profes16 sional and ethical business practices.’’; and 

17 (3) in subsection (c), by striking ‘‘2017’’ and in18 serting ‘‘2022’’. 

19 SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 

20 Section 745A(b) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 379k–1(b)) is amended by adding at 

22 the end the following new paragraph: 

23 ‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLELY

24 IN ELECTRONIC FORMAT.— 


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1 ‘‘(A) IN GENERAL.—Beginning such date as 

2 the Secretary specifies in final guidance issued 

3 under subparagraph (C), presubmissions and 

4 submissions for devices described in paragraph 

5 (1) (and any appeals of action taken by the Sec6 retary with respect to such presubmissions or 

7 submissions) shall be submitted solely in such 

8 electronic format as specified by the Secretary in 

9 such guidance. 

10 ‘‘(B) DRAFT GUIDANCE.—The Secretary 

11 shall, not later than October 1, 2019, issue draft 

12 guidance providing for— 

13 ‘‘(i) any further standards for the sub14 mission by electronic format required under 

15 subparagraph (A); 

16 ‘‘(ii) a timetable for the establishment 

17 by the Secretary of such further standards; 

18 and 

19 ‘‘(iii) set forth criteria for waivers of 

20 and exemptions from the requirements of 

21 this subsection. 

22 ‘‘(C) FINAL GUIDANCE.—The Secretary 

23 shall, not later than 1 year after the close of the 

24 public comment period on the draft guidance 


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1 issued under subparagraph (B), issue final guid2 ance.’’. 

3 SEC. 208. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

5 part 3 of subchapter C of chapter VII of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect 

7 on the day before the date of the enactment of this title, 

8 shall continue to be in effect with respect to the submissions 

9 listed in section 738(a)(2)(A) of such Act (as defined in such 

10 part as of such day) that on or after October 1, 2012, but 

11 before October 1, 2017, were accepted by the Food and Drug 

12 Administration for filing with respect to assessing and col13 lecting any fee required by such part for a fiscal year prior 

14 to fiscal year 2018. 

15 SEC. 209. EFFECTIVE DATE. 

16 The amendments made by this title shall take effect 

17 on October 1, 2017, or the date of the enactment of this 

18 Act, whichever is later, except that fees under part 3 of sub19 chapter C of chapter VII of the Federal Food, Drug, and 

20 Cosmetic Act shall be assessed for all submissions listed in 

21 section 738(a)(2)(A) of such Act received on or after October 

22 1, 2017, regardless of the date of the enactment of this Act. 


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1 SEC. 210. SUNSET CLAUSE. 

2 (a) AUTHORIZATION.—Sections 737 and 738 of the 

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 

4 739j) shall cease to be effective October 1, 2022. 

5 (b) REPORTING REQUIREMENTS.—Section 738A (21 

6 U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic 

7 Act (regarding reauthorization and reporting requirements) 

8 shall cease to be effective January 31, 2023. 

9 (c) PREVIOUS SUNSET PROVISION.— 

10 (1) IN GENERAL.—Effective October 1, 2017, sec11 tion 207(a) of the Medical Device User Fee Amend12 ments of 2012 (Public Law 112–144) is repealed. 

13 (2) CONFORMING AMENDMENT.—The Food and 

14 Drug Administration Safety and Innovation Act 

15 (Public Law 112–144) is amended in the table of con16 tents in section 2 by striking the item relating to sec17 tion 207. 

18 TITLE III—FEES RELATING TO 

19 GENERIC DRUGS 

20 SEC. 301. SHORT TITLE; FINDING. 

21 (a) SHORT TITLE.—This title may be cited as the ‘‘Ge22 neric Drug User Fee Amendments of 2017’’. 

23 (b) FINDING.—The Congress finds that the fees author24 ized by the amendments made in this title will be dedicated 

25 to human generic drug activities, as set forth in the goals 

26 identified for purposes of part 7 of subchapter C of chapter 


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

2 letters from the Secretary of Health and Human Services 

3 to the Chairman of the Committee on Health, Education, 

4 Labor, and Pensions of the Senate and the Chairman of 

5 the Committee on Energy and Commerce of the House of 

6 Representatives, as set forth in the Congressional Record. 

7 SEC. 302. DEFINITIONS. 

8 Section 744A of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 379j–41) is amended— 

10 (1) in paragraph (1)(B), by striking ‘‘applica11 tion for a positron emission tomography drug.’’ and 

12 inserting ‘‘application— 

13 ‘‘(i) for a positron emission tomog14 raphy drug; or 

15 ‘‘(ii) submitted by a State or Federal 

16 governmental entity for a drug that is not 

17 distributed commercially.’’; 

18 (2) by redesignating paragraphs (5) through (12) 

19 as paragraphs (6) through (13), respectively; and 

20 (3) by inserting after paragraph (4) the fol21 lowing: 

22 ‘‘(5) The term ‘contract manufacturing organiza23 tion facility’ means a manufacturing facility of a fin24 ished dosage form of a drug approved pursuant to an 

25 abbreviated new drug application, where such manuVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00121 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 facturing facility is not identified in an approved ab2 breviated new drug application held by the owner of 

3 such facility or an affiliate of such owner or facil4 ity.’’. 

5 SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GE6 NERIC DRUG FEES. 

7 (a) TYPES OF FEES.—Section 744B(a) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)) is 

9 amended— 

10 (1) in the matter preceding paragraph (1), by 

11 striking ‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 

12 2018’’; 

13 (2) in paragraph (1), by adding at the end the 

14 following: 

15 ‘‘(E) SUNSET.—This paragraph shall cease 

16 to be effective October 1, 2022.’’; 

17 (3) in paragraph (2)— 

18 (A) by amending subparagraph (C) to read 

19 as follows: 

20 ‘‘(C) NOTICE.—Not later than 60 days be21 fore the start of each of fiscal years 2018 through 

22 2022, the Secretary shall publish in the Federal 

23 Register the amount of the drug master file fee 

24 established by this paragraph for such fiscal 

25 year.’’; and 


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1 (B) in subparagraph (E)— 

2 (i) in clause (i)— 

3 (I) by striking ‘‘no later than the 

4 date’’ and inserting ‘‘on the earlier 

5 of— 

6 ‘‘(I) the date’’; 

7 (II) by striking the period and in8 serting ‘‘; or’’; and 

9 (III) by adding at the end the fol10 lowing: 

11 ‘‘(II) the date on which the drug 

12 master file holder requests the initial 

13 completeness assessment.’’; and 

14 (ii) in clause (ii), by striking ‘‘notice 

15 provided for in clause (i) or (ii) of subpara16 graph (C), as applicable’’ and inserting 

17 ‘‘notice provided for in subparagraph (C)’’; 

18 (4) in paragraph (3)— 

19 (A) in the heading, by striking ‘‘AND PRIOR

20 APPROVAL SUPPLEMENT’’; 

21 (B) in subparagraph (A), by striking ‘‘or a 

22 prior approval supplement to an abbreviated 

23 new drug application’’; 

24 (C) by amending subparagraphs (B) and 

25 (C) to read as follows: 


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1 ‘‘(B) NOTICE.—Not later than 60 days be2 fore the start of each of fiscal years 2018 through 

3 2022, the Secretary shall publish in the Federal 

4 Register the amount of the fees under subpara5 graph (A) for such fiscal year. 

6 ‘‘(C) FEE DUE DATE.—The fees required by 

7 subparagraphs (A) and (F) shall be due no later 

8 than the date of submission of the abbreviated 

9 new drug application or prior approval supple10 ment for which such fee applies.’’; 

11 (D) in subparagraph (D)— 

12 (i) in the heading, by inserting ‘‘, IS

13 WITHDRAWN PRIOR TO BEING RECEIVED, OR

14 IS NO LONGER RECEIVED’’ after ‘‘RE15 CEIVED’’; and 

16 (ii) by striking ‘‘The Secretary shall’’ 

17 and all that follows through the period and 

18 inserting the following: 

19 ‘‘(i) APPLICATIONS NOT CONSIDERED

20 TO HAVE BEEN RECEIVED AND APPLICA21 TIONS WITHDRAWN PRIOR TO BEING RE22 CEIVED.—The Secretary shall refund 75 

23 percent of the fee paid under subparagraph 

24 (A) for any abbreviated new drug applica25 tion that the Secretary considers not to have 


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1 been received within the meaning of section 

2 505(j)(5)(A) for a cause other than failure 

3 to pay fees, or that has been withdrawn 

4 prior to being received within the meaning 

5 of section 505(j)(5)(A). 

6 ‘‘(ii) APPLICATIONS NO LONGER RE7 CEIVED.—The Secretary shall refund 100 

8 percent of the fee paid under subparagraph 

9 (A) for any abbreviated new drug applica10 tion if the Secretary initially receives the 

11 application under section 505(j)(5)(A) and 

12 subsequently determines that an exclusivity 

13 period for a listed drug should have pre14 vented the Secretary from receiving such 

15 application, such that the abbreviated new 

16 drug application is no longer received with17 in the meaning of section 505(j)(5)(A).’’; 

18 (E) in subparagraph (E), by striking ‘‘or 

19 prior approval supplement’’; and 

20 (F) in the matter preceding clause (i) of 

21 subparagraph (F)— 

22 (i) by striking ‘‘2012’’ and inserting 

23 ‘‘2017’’; and 

24 (ii) by striking ‘‘subsection (d)(3)’’ and 

25 inserting ‘‘subsection (d)(2)’’; 


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1 (5) in paragraph (4)— 

2 (A) in subparagraph (A)— 

3 (i) in the matter preceding clause (i) 

4 and in clause (iii), by striking ‘‘, or in5 tended to be identified, in at least one ge6 neric drug submission that is pending or’’ 

7 and inserting ‘‘in at least one generic drug 

8 submission that is’’; 

9 (ii) in clause (i), by striking ‘‘or in10 tended to be identified in at least one ge11 neric drug submission that is pending or’’ 

12 and inserting ‘‘in at least one generic drug 

13 submission that is’’; 

14 (iii) in clause (ii), by striking ‘‘pro15 duces,’’ and all that follows through ‘‘such 

16 a’’ and inserting ‘‘is identified in at least 

17 one generic drug submission in which the 

18 facility is approved to produce one or more 

19 active pharmaceutical ingredients or in a 

20 Type II active pharmaceutical ingredient 

21 drug master file referenced in at least one 

22 such’’; and 

23 (iv) in clause (iii), by striking ‘‘to fees 

24 under both such clauses’’ and inserting 


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1 ‘‘only to the fee attributable to the manufac2 ture of the finished dosage forms’’; and 

3 (B) by amending subparagraphs (C) and 

4 (D) to read as follows: 

5 ‘‘(C) NOTICE.—Within the timeframe speci6 fied in subsection (d)(1), the Secretary shall pub7 lish in the Federal Register the amount of the 

8 fees under subparagraph (A) for such fiscal 

9 year.’’. 

10 ‘‘(D) FEE DUE DATE.—For each of fiscal 

11 years 2018 through 2022, the fees under subpara12 graph (A) for such fiscal year shall be due on the 

13 later of— 

14 ‘‘(i) the first business day on or after 

15 October 1 of each such year; or 

16 ‘‘(ii) the first business day after the en17 actment of an appropriations Act providing 

18 for the collection and obligation of fees for 

19 such year under this section for such year.’’; 

20 (6) by redesignating paragraph (5) as para21 graph (6); and 

22 (7) by inserting after paragraph (4) the fol23 lowing: 

24 ‘‘(5) GENERIC DRUG APPLICANT PROGRAM

25 FEE.— 


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1 ‘‘(A) IN GENERAL.—A generic drug appli2 cant program fee shall be assessed annually as 

3 described in subsection (b)(2)(E). 

4 ‘‘(B) AMOUNT.—The amount of fees estab5 lished under subparagraph (A) shall be estab6 lished under subsection (d). 

7 ‘‘(C) NOTICE.—Within the timeframe speci8 fied in subsection (d)(1), the Secretary shall pub9 lish in the Federal Register the amount of the 

10 fees under subparagraph (A) for such fiscal year. 

11 ‘‘(D) FEE DUE DATE.—For each of fiscal 

12 years 2018 through 2022, the fees under subpara13 graph (A) for such fiscal year shall be due on the 

14 later of— 

15 ‘‘(i) the first business day on or after 

16 October 1 of each such fiscal year; or 

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

18 date of enactment of an appropriations Act 

19 providing for the collection and obligation 

20 of fees for such fiscal year under this section 

21 for such fiscal year.’’. 

22 (b) FEE REVENUE AMOUNTS.—Section 744B(b) of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

24 42(b)) is amended— 

25 (1) in paragraph (1)— 


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1 (A) in subparagraph (A)— 

2 (i) in the heading, by striking ‘‘2013’’ 

3 and inserting ‘‘2018’’; 

4 (ii) by striking ‘‘2013’’ and inserting 

5 ‘‘2018’’; 

6 (iii) by striking ‘‘$299,000,000’’ and 

7 inserting ‘‘$493,600,000’’; and 

8 (iv) by striking ‘‘Of that amount’’ and 

9 all that follows through the end of clause 

10 (ii); and 

11 (B) in subparagraph (B)— 

12 (i) in the heading, by striking ‘‘2014

13 THROUGH 2017’’ and inserting ‘‘2019

14 THROUGH 2022’’; 

15 (ii) by striking ‘‘2014 through 2017’’ 

16 and inserting ‘‘2019 through 2022’’; 

17 (iii) by striking ‘‘paragraphs (2) 

18 through (4)’’ and inserting ‘‘paragraphs (2) 

19 through (5)’’; and 

20 (iv) by striking ‘‘$299,000,000’’ and 

21 inserting ‘‘$493,600,000’’; and 

22 (2) in paragraph (2)— 

23 (A) in the matter preceding subparagraph 

24 (A)— 


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1 (i) by striking ‘‘paragraph (1)(A)(ii) 

2 for fiscal year 2013 and paragraph (1)(B) 

3 for each of fiscal years 2014 through 2017’’ 

4 and inserting ‘‘such paragraph for a fiscal 

5 year’’; and 

6 (ii) by striking ‘‘through (4)’’ and in7 serting ‘‘through (5)’’; 

8 (B) in subparagraph (A), by striking ‘‘Six 

9 percent’’ and inserting ‘‘Five percent’’; 

10 (C) by amending subparagraphs (B) and 

11 (C) to read as follows: 

12 ‘‘(B) Thirty-three percent shall be derived 

13 from fees under subsection (a)(3) (relating to ab14 breviated new drug applications). 

15 ‘‘(C) Twenty percent shall be derived from 

16 fees under subsection (a)(4)(A)(i) (relating to ge17 neric drug facilities). The amount of the fee for 

18 a contract manufacturing organization facility 

19 shall be equal to one-third the amount of the fee 

20 for a facility that is not a contract manufac21 turing organization facility. The amount of the 

22 fee for a facility located outside the United 

23 States and its territories and possessions shall be 

24 $15,000 higher than the amount of the fee for a 


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1 facility located in the United States and its ter2 ritories and possessions.’’; 

3 (D) in subparagraph (D)— 

4 (i) by striking ‘‘Fourteen percent’’ and 

5 inserting ‘‘Seven percent’’; 

6 (ii) by striking ‘‘not less than $15,000 

7 and not more than $30,000’’ and inserting 

8 ‘‘$15,000’’; and 

9 (iii) by striking ‘‘, as determined’’ and 

10 all that follows through the period at the 

11 end and inserting a period; and 

12 (E) by adding at the end the following: 

13 ‘‘(E)(i) Thirty-five percent shall be derived 

14 from fees under subsection (a)(5) (relating to ge15 neric drug applicant program fees). For pur16 poses of this subparagraph, if a person has affili17 ates, a single program fee shall be assessed with 

18 respect to that person, including its affiliates, 

19 and may be paid by that person or any one of 

20 its affiliates. The Secretary shall determine the 

21 fees as follows: 

22 ‘‘(I) If a person (including its affili23 ates) owns at least one but not more than 

24 5 approved abbreviated new drug applica25 tions on the due date for the fee under this 


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1 subsection, the person (including its affili2 ates) shall be assessed a small business ge3 neric drug applicant program fee equal to 

4 one-tenth of the large size operation generic 

5 drug applicant program fee. 

6 ‘‘(II) If a person (including its affili7 ates) owns at least 6 but not more than 19 

8 approved abbreviated new drug applications 

9 on the due date for the fee under this sub10 section, the person (including its affiliates) 

11 shall be assessed a medium size operation 

12 generic drug applicant program fee equal to 

13 two-fifths of the large size operation generic 

14 drug applicant program fee. 

15 ‘‘(III) If a person (including its affili16 ates) owns 20 or more approved abbreviated 

17 new drug applications on the due date for 

18 the fee under this subsection, the person (in19 cluding its affiliates) shall be assessed a 

20 large size operation generic drug applicant 

21 program fee. 

22 ‘‘(ii) For purposes of this subparagraph, an 

23 abbreviated new drug application shall be 

24 deemed not to be approved if the applicant has 

25 submitted a written request for withdrawal of 


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1 approval of such abbreviated new drug applica2 tion by April 1 of the previous fiscal year.’’. 

3 (c) ADJUSTMENTS.—Section 744B(c) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is 

5 amended— 

6 (1) in paragraph (1)— 

7 (A) by striking ‘‘2014’’ and inserting 

8 ‘‘2019’’; 

9 (B) by inserting ‘‘to equal the product of the 

10 total revenues established in such notice for the 

11 prior fiscal year multiplied’’ after ‘‘a fiscal 

12 year,’’; and 

13 (C) by striking the flush text following sub14 paragraph (C); and 

15 (2) in paragraph (2)— 

16 (A) by striking ‘‘2017’’ each place it ap17 pears and inserting ‘‘2022’’; and 

18 (B) by striking ‘‘2018’’ and inserting 

19 ‘‘2023’’. 

20 (d) ANNUAL FEE SETTING.—Section 744B of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) is 

22 amended— 

23 (1) in subsection (c)(2), by striking ‘‘Such fees 

24 may only be used in fiscal year 2018.’’; and 

25 (2) in subsection (d)— 


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1 (A) by striking paragraphs (1) and (2) and 

2 inserting the following: 

3 ‘‘(1) FISCAL YEARS 2018 THROUGH 2022.—Not 

4 more than 60 days before the first day of each of fis5 cal years 2018 through 2022, the Secretary shall es6 tablish the fees described in paragraphs (2) through 

7 (5) of subsection (a), based on the revenue amounts 

8 established under subsection (b) and the adjustments 

9 provided under subsection (c).’’; 

10 (B) by redesignating paragraph (3) as 

11 paragraph (2); and 

12 (C) in paragraph (2) (as so redesignated), 

13 in the matter preceding subparagraph (A), by 

14 striking ‘‘fees under paragraphs (1) and (2)’’ 

15 and inserting ‘‘fee under paragraph (1)’’. 

16 (e) IDENTIFICATION OF FACILITIES.—Section 744B(f) 

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

18 379j–42(f)) is amended— 

19 (1) by striking paragraph (1); 

20 (2) by redesignating paragraphs (2) through (4) 

21 as paragraphs (1) through (3), respectively; 

22 (3) in paragraph (1) (as so redesignated)— 

23 (A) by striking ‘‘paragraph (4)’’ and insert24 ing ‘‘paragraph (3)’’; and 


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1 (B) by striking ‘‘Such information shall’’ 

2 and all that follows through the end of subpara3 graph (B) and inserting ‘‘Such information 

4 shall, for each fiscal year, be submitted, updated, 

5 or reconfirmed on or before June 1 of the pre6 vious fiscal year.’’; and 

7 (4) in paragraph (2), as so redesignated— 

8 (A) in the heading, by striking ‘‘CONTENTS

9 OF NOTICE’’ and inserting ‘‘INFORMATION RE10 QUIRED TO BE SUBMITTED’’; 

11 (B) in the matter preceding subparagraph 

12 (A), by striking ‘‘paragraph (2)’’ and inserting 

13 ‘‘paragraph (1)’’; 

14 (C) in subparagraph (A), by striking ‘‘or 

15 intended to be identified’’; 

16 (D) in subparagraph (D), by striking 

17 ‘‘and’’ at the end; 

18 (E) in subparagraph (E), by striking the 

19 period and inserting ‘‘; and’’; and 

20 (F) by adding at the end the following: 

21 ‘‘(F) whether the facility is a contract man22 ufacturing organization facility.’’. 

23 (f) EFFECT OF FAILURE TO PAY FEES.—Section 

24 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 379–42(g)) is amended— 


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1 (1) in paragraph (1), by adding at the end the 

2 following: ‘‘This paragraph shall cease to be effective 

3 on October 1, 2022.’’; 

4 (2) in paragraph (2)(C)(ii), by striking ‘‘of 

5 505(j)(5)(A)’’ and inserting ‘‘of section 505(j)(5)(A)’’; 

6 and 

7 (3) by adding at the end the following: 

8 ‘‘(5) GENERIC DRUG APPLICANT PROGRAM

9 FEE.— 

10 ‘‘(A) IN GENERAL.—A person who fails to 

11 pay a fee as required under subsection (a)(5) by 

12 the date that is 20 calendar days after the due 

13 date, as specified in subparagraph (D) of such 

14 subsection, shall be subject to the following: 

15 ‘‘(i) The Secretary shall place the per16 son on a publicly available arrears list. 

17 ‘‘(ii) Any abbreviated new drug appli18 cation submitted by the generic drug appli19 cant or an affiliate of such applicant shall 

20 not be received, within the meaning of sec21 tion 505(j)(5)(A). 

22 ‘‘(iii) All drugs marketed pursuant to 

23 any abbreviated new drug application held 

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1 plicant shall be deemed misbranded under 

2 section 502(aa). 

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

4 penalties under subparagraph (A) shall apply 

5 until the fee required under subsection (a)(5) is 

6 paid.’’. 

7 (g) LIMITATIONS.—Section 744B(h)(2) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 379–42(h)(2)) is 

9 amended by striking ‘‘for Type II active pharmaceutical in10 gredient drug master files, abbreviated new drug applica11 tions and prior approval supplements, and generic drug fa12 cilities and active pharmaceutical ingredient facilities’’. 

13 (h) CREDITING AND AVAILABILITY OF FEES.—Section 

14 744B(i) of the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 379–42(i)) is amended— 

16 (1) in paragraph (2)— 

17 (A) by striking subparagraph (C) (relating 

18 to fee collection during first program year); 

19 (B) in subparagraph (D)— 

20 (i) in the heading, by striking ‘‘IN

21 SUBSEQUENT YEARS’’; and 

22 (ii) by striking ‘‘(after fiscal year 

23 2013)’’; and 

24 (C) by redesignating subparagraph (D) as 

25 subparagraph (C); and 


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1 (2) in paragraph (3), by striking ‘‘fiscal years 

2 2013 through 2017’’ and inserting ‘‘fiscal years 2018 

3 through 2022’’. 

4 (i) INFORMATION ON ABBREVIATED NEW DRUG APPLI5 CATIONS HELD BY APPLICANTS AND THEIR AFFILIATES.— 

6 Section 744B of the Federal Food, Drug, and Cosmetic Act 

7 (21 U.S.C. 379–42) is amended by adding at the end the 

8 following: 

9 ‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG AP10 PLICATIONS OWNED BY APPLICANTS AND THEIR AFFILI11 ATES.— 

12 ‘‘(1) IN GENERAL.—By April 1 of each year, 

13 each person that owns an abbreviated new drug ap14 plication, or any affiliate of such person, shall submit 

15 to the Secretary a list of— 

16 ‘‘(A) all approved abbreviated new drug ap17 plications owned by such person; and 

18 ‘‘(B) if any affiliate of such person also 

19 owns an abbreviated new drug application, all 

20 affiliates that own any such abbreviated new 

21 drug application and all approved abbreviated 

22 new drug applications owned by any such affil23 iate. 


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1 ‘‘(2) FORMAT AND METHOD.—The Secretary 

2 shall specify in guidance the format and method for 

3 submission of lists under this subsection.’’. 

4 SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS. 

5 Section 744C of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 379j–43) is amended— 

7 (1) in subsection (a)— 

8 (A) by striking ‘‘2013’’ and inserting 

9 ‘‘2018’’; and 

10 (B) by striking ‘‘Generic Drug User Fee 

11 Amendments of 2012’’ and inserting ‘‘Generic 

12 Drug User Fee Amendments of 2017’’; 

13 (2) in subsection (b), by striking ‘‘2013’’ and in14 serting ‘‘2018’’; and 

15 (3) in subsection (d), by striking ‘‘2017’’ each 

16 place it appears and inserting ‘‘2022’’. 

17 SEC. 305. SUNSET DATES. 

18 (a) AUTHORIZATION.—Sections 744A and 744B of the 

19 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

20 41; 379j–42) shall cease to be effective October 1, 2022. 

21 (b) REPORTING REQUIREMENTS.—Section 744C of the 

22 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

23 43) shall cease to be effective January 31, 2023. 

24 (c) PREVIOUS SUNSET PROVISION.—Effective October 

25 1, 2017, subsections (a) and (b) of section 304 of the Food 


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1 and Drug Administration Safety and Innovation Act (Pub2 lic Law 112–144) are repealed. 

3 SEC. 306. EFFECTIVE DATE. 

4 The amendments made by this title shall take effect 

5 on October 1, 2017, or the date of the enactment of this 

6 Act, whichever is later, except that fees under part 7 of sub7 chapter C of chapter VII of the Federal Food, Drug, and 

8 Cosmetic Act shall be assessed for all abbreviated new drug 

9 applications received on or after October 1, 2017, regardless 

10 of the date of the enactment of this Act. 

11 SEC. 307. SAVINGS CLAUSE. 

12 Notwithstanding the amendments made by this title, 

13 part 7 of subchapter C of chapter VII of the Federal Food, 

14 Drug, and Cosmetic Act, as in effect on the day before the 

15 date of the enactment of this title, shall continue to be in 

16 effect with respect to abbreviated new drug applications (as 

17 defined in such part as of such day) that on or after October 

18 1, 2012, but before October 1, 2017, were received by the 

19 Food and Drug Administration within the meaning of 

20 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior ap21 proval supplements that were submitted, and drug master 

22 files for Type II active pharmaceutical ingredients that 

23 were first referenced with respect to assessing and collecting 

24 any fee required by such part for a fiscal year prior to fiscal 

25 year 2018. 


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1 TITLE IV—FEES RELATING TO 

2 BIOSIMILAR BIOLOGICAL 

3 PRODUCTS 

4 SEC. 401. SHORT TITLE; FINDING. 

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

6 ‘‘Biosimilar User Fee Amendments of 2017’’. 

7 (b) FINDING.—The Congress finds that the fees author8 ized by the amendments made in this title will be dedicated 

9 to expediting the process for the review of biosimilar biologi10 cal product applications, including postmarket safety ac11 tivities, as set forth in the goals identified for purposes of 

12 part 8 of subchapter C of chapter VII of the Federal Food, 

13 Drug, and Cosmetic Act, in the letters from the Secretary 

14 of Health and Human Services to the Chairman of the 

15 Committee on Health, Education, Labor, and Pensions of 

16 the Senate and the Chairman of the Committee on Energy 

17 and Commerce of the House of Representatives, as set forth 

18 in the Congressional Record. 

19 SEC. 402. DEFINITIONS. 

20 (a) ADJUSTMENT FACTOR.—Section 744G(1) of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

22 51(1)) is amended to read as follows: 

23 ‘‘(1) The term ‘adjustment factor’ applicable to a 

24 fiscal year is the Consumer Price Index for all urban 

25 consumers (all items; United States city average) 


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1 (Washington-Baltimore, DC-MD, VA-WV; Not Sea2 sonally Adjusted; All items) for October of the pre3 ceding fiscal year divided by such Index for October 

4 2011 divided by such index for September 2011.’’. 

5 (b) BIOSIMILAR BIOLOGICAL PRODUCT.—Section 

6 744G(3) of the Federal Food, Drug, and Cosmetic Act (21 

7 U.S.C. 379j–51(3)) is amended by striking ‘‘means a prod8 uct’’ and inserting ‘‘means a specific strength of a biological 

9 product in final dosage form’’. 

10 SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR 

11 FEES. 

12 (a) TYPES OF FEES.—Section 744H(a) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is 

14 amended— 

15 (1) in the matter preceding paragraph (1), by 

16 striking ‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 

17 2018’’; 

18 (2) in the heading of paragraph (1), by striking 

19 ‘‘BIOSIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGI20 CAL PRODUCT’’; 

21 (3) in paragraph (1)(A)(i), by striking 

22 ‘‘(b)(1)(A)’’ and inserting ‘‘(c)(5)’’; 

23 (4) in paragraph (1)(B)(i), by striking 

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1 ment’’ and inserting ‘‘(c)(5) for the biosimilar biologi2 cal product development program’’; 

3 (5) in paragraph (1)(B)(ii), by striking ‘‘annual 

4 biosimilar biological product development program 

5 fee’’ and inserting ‘‘annual biosimilar biological prod6 uct development fee’’; 

7 (6) in paragraph (1)(B)(iii), by striking ‘‘an8 nual biosimilar development program fee’’ and insert9 ing ‘‘annual biosimilar biological product develop10 ment fee’’; 

11 (7) in paragraph (1)(B), by adding at the end 

12 the following: 

13 ‘‘(iv) REFUND.—If a person submits a 

14 marketing application for a biosimilar bio15 logical product before October 1 of a fiscal 

16 year and such application is accepted for 

17 filing on or after October 1 of such fiscal 

18 year, the person may request a refund equal 

19 to the annual biosimilar development fee 

20 paid by the person for the product for such 

21 fiscal year. To qualify for consideration for 

22 a refund under this clause, a person shall 

23 submit to the Secretary a written request 

24 for such refund not later than 180 days 


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1 after the marketing application is accepted 

2 for filing.’’; 

3 (8) in paragraph (1)(C), by striking ‘‘for a prod4 uct effective October 1 of a fiscal year by,’’ and insert5 ing ‘‘for a product, effective October 1 of a fiscal year, 

6 by,’’; 

7 (9) in paragraph (1)(D)— 

8 (A) in clause (i) in the matter preceding 

9 subclause (I), by inserting ‘‘, if the person seeks 

10 to resume participation in such program,’’ before 

11 ‘‘pay a fee’’; 

12 (B) in clause (i)(I), by inserting after 

13 ‘‘grants a request’’ the following: ‘‘by such per14 son’’; and 

15 (C) in clause (i)(II), by inserting after ‘‘dis16 continued)’’ the following: ‘‘by such person’’; 

17 (10) in the heading of paragraph (1)(E), by 

18 striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; 

19 (11) in the heading of subparagraph (F) of para20 graph (1), by striking ‘‘BIOSIMILAR DEVELOPMENT

21 PROGRAM FEES’’ and inserting ‘‘BIOSIMILAR BIOLOGI22 CAL PRODUCT DEVELOPMENT FEES’’; 

23 (12) in paragraph (1)(F)— 


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1 (A) in the heading of subparagraph (F), by 

2 striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’ 

3 before ‘‘FEES’’; and 

4 (B) by amending clause (i) to read as fol5 lows: 

6 ‘‘(i) REFUNDS.—Except as provided in 

7 subparagraph (B)(iv), the Secretary shall 

8 not refund any initial or annual biosimilar 

9 biological product development fee paid 

10 under subparagraph (A) or (B), or any re11 activation fee paid under subparagraph 

12 (D).’’; 

13 (13) in paragraph (2)— 

14 (A) in the heading of paragraph (2), by 

15 striking ‘‘AND SUPPLEMENT’’; 

16 (B) by amending subparagraphs (A) and 

17 (B) to read as follows: 

18 ‘‘(A) IN GENERAL.—Each person that sub19 mits, on or after October 1, 2017, a biosimilar 

20 biological product application shall be subject to 

21 the following fees: 

22 ‘‘(i) A fee established under subsection 

23 (c)(5) for a biosimilar biological product 

24 application for which clinical data (other 

25 than comparative bioavailability studies) 


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1 with respect to safety or effectiveness are re2 quired for approval. 

3 ‘‘(ii) A fee established under subsection 

4 (c)(5) for a biosimilar biological product 

5 application for which clinical data (other 

6 than comparative bioavailability studies) 

7 with respect to safety or effectiveness are not 

8 required for approval. Such fee shall be 

9 equal to half of the amount of the fee de10 scribed in clause (i). 

11 ‘‘(B) RULE OF APPLICABILITY; TREATMENT

12 OF CERTAIN PREVIOUSLY PAID FEES.—Any per13 son who pays a fee under subparagraph (A), (B), 

14 or (D) of paragraph (1) for a product before Oc15 tober 1, 2017, but submits a biosimilar biological 

16 product application for that product after such 

17 date, shall— 

18 ‘‘(i) be subject to any biosimilar bio19 logical product application fees that may be 

20 assessed at the time when such biosimilar 

21 biological product application is submitted; 

22 and 

23 ‘‘(ii) be entitled to no reduction of such 

24 application fees based on the amount of fees 

25 paid for that product before October 1, 


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1 2017, under such subparagraph (A), (B), or 

2 (D).’’; 

3 (C) in the heading of subparagraph (D), by 

4 striking ‘‘OR SUPPLEMENT’’; and 

5 (D) in subparagraphs (C) through (F)— 

6 (i) by striking ‘‘or supplement’’ each 

7 place it appears; and 

8 (ii) in subparagraph (D), by striking 

9 ‘‘or a supplement’’; and 

10 (14) by amending paragraph (3) to read as fol11 lows: 

12 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT PRO13 GRAM FEE.— 

14 ‘‘(A) IN GENERAL.—Each person who is 

15 named as the applicant in a biosimilar biologi16 cal product application shall pay the annual 

17 biosimilar biological product program fee estab18 lished for a fiscal year under subsection (c)(5) 

19 for each biosimilar biological product that— 

20 ‘‘(i) is identified in such a biosimilar 

21 biological product application approved as 

22 of October 1 of such fiscal year; and 

23 ‘‘(ii) as of October 1 of such fiscal 

24 year, does not appear on a list, developed 


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1 and maintained by the Secretary, of discon2 tinued biosimilar biological products. 

3 ‘‘(B) DUE DATE.—The biosimilar biological 

4 product program fee for a fiscal year shall be due 

5 on the later of— 

6 ‘‘(i) the first business day on or after 

7 October 1 of each such year; or 

8 ‘‘(ii) the first business day after the en9 actment of an appropriations Act providing 

10 for the collection and obligation of fees for 

11 such year under this section. 

12 ‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 

13 The biosimilar biological product program fee 

14 shall be paid only once for each product for each 

15 fiscal year. 

16 ‘‘(D) LIMITATION.—A person who is named 

17 as the applicant in a biosimilar biological prod18 uct application shall not be assessed more than 

19 5 biosimilar biological product program fees for 

20 a fiscal year for biosimilar biological products 

21 identified in such biosimilar biological product 

22 application.’’. 

23 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec24 tion 744H of the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 379j–52) is amended to read as follows: 


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1 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

3 fees under subsection (a) shall be established to gen4 erate a total revenue amount equal to the sum of— 

5 ‘‘(A) $45,000,000; and 

6 ‘‘(B) the dollar amount equal to the fiscal 

7 year 2018 adjustment (as determined under sub8 section (c)(4)). 

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

10 the fiscal years 2019 through 2022, fees under sub11 section (a) shall, except as provided in subsection (c), 

12 be established to generate a total revenue amount 

13 equal to the sum of— 

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

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

16 ‘‘(B) the dollar amount equal to the infla17 tion adjustment for the fiscal year (as deter18 mined under subsection (c)(1)); 

19 ‘‘(C) the dollar amount equal to the capac20 ity planning adjustment for the fiscal year (as 

21 determined under subsection (c)(2)); and 

22 ‘‘(D) the dollar amount equal to the oper23 ating reserve adjustment for the fiscal year, if 

24 applicable (as determined under subsection 

25 (c)(3)). 


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1 ‘‘(3) ALLOCATION OF REVENUE AMOUNT AMONG

2 FEES; LIMITATIONS ON FEE AMOUNTS.— 

3 ‘‘(A) ALLOCATION.—The Secretary shall de4 termine the percentage of the total revenue 

5 amount for a fiscal year to be derived from, re6 spectively— 

7 ‘‘(i) initial and annual biosimilar de8 velopment fees and reactivation fees under 

9 subsection (a)(1); 

10 ‘‘(ii) biosimilar biological product ap11 plication fees under subsection (a)(2); and 

12 ‘‘(iii) biosimilar biological product 

13 program fees under subsection (a)(3). 

14 ‘‘(B) LIMITATIONS ON FEE AMOUNTS.— 

15 Until the first fiscal year for which the capacity 

16 planning adjustment under subsection (c)(2) is 

17 effective, the amount of any fee under subsection 

18 (a) for a fiscal year after fiscal year 2018 shall 

19 not exceed 125 percent of the amount of such fee 

20 for fiscal year 2018. 

21 ‘‘(C) BIOSIMILAR BIOLOGICAL PRODUCT DE22 VELOPMENT FEES.—The initial biosimilar bio23 logical product development fee under subsection 

24 (a)(1)(A) for a fiscal year shall be equal to the 

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1 ment fee under subsection (a)(1)(B) for that fis2 cal year. 

3 ‘‘(D) REACTIVATION FEE.—The reactivation 

4 fee under subsection (a)(1)(D) for a fiscal year 

5 shall be equal to twice the amount of the annual 

6 biosimilar biological product development fee 

7 under subsection (a)(1)(B) for that fiscal year. 

8 ‘‘(4) ANNUAL BASE REVENUE.—For purposes of 

9 paragraph (2), the dollar amount of the annual base 

10 revenue for a fiscal year shall be the dollar amount 

11 of the total revenue amount for the previous fiscal 

12 year, excluding any adjustments to such revenue 

13 amount under subsection (c)(3).’’. 

14 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 

15 744H of the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 379j–52) is amended— 

17 (1) by redesignating subsections (c) through (h) 

18 as subsections (d) through (i), respectively; 

19 (2) in subsections (a)(2)(F) and (g), by striking 

20 ‘‘subsection (c)’’ and inserting ‘‘subsection (d)’’; 

21 (3) in subsection (a)(4)(A), by striking ‘‘sub22 section (b)(1)(F)’’ and inserting ‘‘subsection (c)(5)’’; 

23 and 

24 (4) by inserting after subsection (b) the fol25 lowing: 


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

2 ‘‘(1) INFLATION ADJUSTMENT.— 

3 ‘‘(A) IN GENERAL.—For purposes of sub4 section (b)(2)(B), the dollar amount of the infla5 tion adjustment to the annual base revenue for 

6 each fiscal year shall be equal to the product 

7 of— 

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

9 fiscal year under subsection (b); and 

10 ‘‘(ii) the inflation adjustment percent11 age under subparagraph (B). 

12 ‘‘(B) INFLATION ADJUSTMENT PERCENT13 AGE.—The inflation adjustment percentage 

14 under this subparagraph for a fiscal year is 

15 equal to the sum of— 

16 ‘‘(i) the average annual percent change 

17 in the cost, per full-time equivalent position 

18 of the Food and Drug Administration, of all 

19 personnel compensation and benefits paid 

20 with respect to such positions for the first 3 

21 years of the preceding 4 fiscal years, multi22 plied by the proportion of personnel com23 pensation and benefits costs to total costs of 

24 the process for the review of biosimilar bio25 logical product applications (as defined in 


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1 section 744G(13)) for the first 3 years of the 

2 preceding 4 fiscal years; and 

3 ‘‘(ii) the average annual percent 

4 change that occurred in the Consumer Price 

5 Index for urban consumers (Washington6 Baltimore, DC–MD–VA–WV; Not Season7 ally Adjusted; All items; Annual Index) for 

8 the first 3 years of the preceding 4 years of 

9 available data multiplied by the proportion 

10 of all costs other than personnel compensa11 tion and benefits costs to total costs of the 

12 process for the review of biosimilar biologi13 cal product applications (as defined in sec14 tion 744G(13)) for the first 3 years of the 

15 preceding 4 fiscal years. 

16 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

17 ‘‘(A) IN GENERAL.—Beginning with the fis18 cal year described in subparagraph (B)(ii)(II), 

19 the Secretary shall, in addition to the adjust20 ment under paragraph (1), further increase the 

21 fee revenue and fees under this section for a fis22 cal year to reflect changes in the resource capac23 ity needs of the Secretary for the process for the 

24 review of biosimilar biological product applica25 tions. 


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1 ‘‘(B) CAPACITY PLANNING METHODOLOGY.— 

2 ‘‘(i) DEVELOPMENT; EVALUATION AND

3 REPORT.—The Secretary shall obtain, 

4 through a contract with an independent ac5 counting or consulting firm, a report evalu6 ating options and recommendations for a 

7 new methodology to accurately assess 

8 changes in the resource and capacity needs 

9 of the process for the review of biosimilar 

10 biological product applications. The capac11 ity planning methodological options and 

12 recommendations presented in such report 

13 shall utilize and be informed by personnel 

14 time reporting data as an input. The report 

15 shall be published for public comment not 

16 later than September 30, 2020. 

17 ‘‘(ii) ESTABLISHMENT AND IMPLEMEN18 TATION.—After review of the report de19 scribed in clause (i) and receipt and review 

20 of public comments thereon, the Secretary 

21 shall establish a capacity planning method22 ology for purposes of this paragraph, which 

23 shall— 


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1 ‘‘(I) incorporate such approaches 

2 and attributes as the Secretary deter3 mines appropriate; and 

4 ‘‘(II) be effective beginning with 

5 the first fiscal year for which fees are 

6 set after such capacity planning meth7 odology is established. 

8 ‘‘(C) LIMITATION.—Under no circumstances 

9 shall an adjustment under this paragraph result 

10 in fee revenue for a fiscal year that is less than 

11 the sum of the amounts under subsections 

12 (b)(2)(A) (the annual base revenue for the fiscal 

13 year) and (b)(2)(B) (the dollar amount of the in14 flation adjustment for the fiscal year). 

15 ‘‘(D) PUBLICATION IN FEDERAL REG16 ISTER.—The Secretary shall publish in the Fed17 eral Register notice under paragraph (5) the fee 

18 revenue and fees resulting from the adjustment 

19 and the methodologies under this paragraph. 

20 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

21 ‘‘(A) INTERIM APPLICATION; FEE REDUC22 TION.—Until the first fiscal year for which the 

23 capacity planning adjustment under paragraph 

24 (2) is effective, the Secretary may, in addition to 

25 the adjustment under paragraph (1), reduce the 


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1 fee revenue and fees under this section for a fis2 cal year as the Secretary determines appropriate 

3 for long-term financial planning purposes. 

4 ‘‘(B) GENERAL APPLICATION AND METHOD5 OLOGY.—Beginning with the first fiscal year for 

6 which the capacity planning adjustment under 

7 paragraph (2) is effective, the Secretary may, in 

8 addition to the adjustments under paragraphs 

9 (1) and (2)— 

10 ‘‘(i) reduce the fee revenue and fees 

11 under this section as the Secretary deter12 mines appropriate for long-term financial 

13 planning purposes; or 

14 ‘‘(ii) increase the fee revenue and fees 

15 under this section if such an adjustment is 

16 necessary to provide for not more than 21 

17 weeks of operating reserves of carryover user 

18 fees for the process for the review of bio19 similar biological product applications. 

20 ‘‘(C) FEDERAL REGISTER NOTICE.—If an 

21 adjustment under subparagraph (A) or (B) is 

22 made, the rationale for the amount of the in23 crease or decrease (as applicable) in fee revenue 

24 and fees shall be contained in the annual Federal 


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1 Register notice under paragraph (5) establishing 

2 fee revenue and fees for the fiscal year involved. 

3 ‘‘(4) FISCAL YEAR 2018 ADJUSTMENT.— 

4 ‘‘(A) IN GENERAL.—For fiscal year 2018, 

5 the Secretary shall adjust the fee revenue and 

6 fees under this section in such amount (if any) 

7 as needed to reflect an updated assessment of the 

8 workload for the process for the review of bio9 similar biological product applications. 

10 ‘‘(B) METHODOLOGY.—The Secretary shall 

11 publish under paragraph (5) a description of the 

12 methodology used to calculate the fiscal year 

13 2018 adjustment under this paragraph in the 

14 Federal Register notice establishing fee revenue 

15 and fees for fiscal year 2018. 

16 ‘‘(C) LIMITATION.—No adjustment under 

17 this paragraph shall result in an increase in fee 

18 revenue and fees under this section in excess of 

19 $9,000,000. 

20 ‘‘(5) ANNUAL FEE SETTING.—For fiscal year 

21 2018 and each subsequent fiscal year, the Secretary 

22 shall, not later than 60 days before the start of each 

23 such fiscal year— 

24 ‘‘(A) establish, for the fiscal year, initial 

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1 opment fees and reactivation fees under sub2 section (a)(1), biosimilar biological product ap3 plication fees under subsection (a)(2), and bio4 similar biological product program fees under 

5 subsection (a)(3), based on the revenue amounts 

6 established under subsection (b) and the adjust7 ments provided under this subsection; and 

8 ‘‘(B) publish such fee revenue and fees in 

9 the Federal Register. 

10 ‘‘(6) LIMIT.—The total amount of fees assessed 

11 for a fiscal year under this section may not exceed the 

12 total costs for such fiscal year for the resources allo13 cated for the process for the review of biosimilar bio14 logical product applications.’’. 

15 (d) APPLICATION FEE WAIVER FOR SMALL BUSI16 NESS.—Subsection (d)(1) of section 744H of the Federal 

17 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as re18 designated by subsection (c)(1), is amended— 

19 (1) by striking subparagraph (B); 

20 (2) by striking ‘‘shall pay—’’ and all that fol21 lows through ‘‘application fees’’ and inserting ‘‘shall 

22 pay application fees’’; and 

23 (3) by striking ‘‘; and’’ at the end and inserting 

24 a period. 


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1 (e) EFFECT OF FAILURE TO PAY FEES.—Subsection 

2 (e) of section 744H of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 379j–52), as redesignated by subsection 

4 (c)(1), is amended by striking ‘‘all fees’’ and inserting ‘‘all 

5 such fees’’. 

6 (f) CREDITING AND AVAILABILITY OF FEES.—Sub7 section (f) of section 744H of the Federal Food, Drug, and 

8 Cosmetic Act (21 U.S.C. 379j–52), as redesignated by sub9 section (c)(1), is amended— 

10 (1) in paragraph (2)— 

11 (A) by striking subparagraph (C) (relating 

12 to fee collection during first program year) and 

13 inserting the following: 

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

15 considered to have met the requirements of sub16 paragraph (B) in any fiscal year if the costs de17 scribed in such subparagraph are not more than 

18 15 percent below the level specified in such sub19 paragraph.’’; and 

20 (B) in subparagraph (D)— 

21 (i) in the heading, by striking ‘‘IN

22 SUBSEQUENT YEARS’’; and 

23 (ii) by striking ‘‘(after fiscal year 

24 2013)’’; and 


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1 (2) in paragraph (3), by striking ‘‘2013 through 

2 2017’’ and inserting ‘‘2018 through 2022’’. 

3 SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 

4 Section 744I of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 379j–53) is amended— 

6 (1) in subsection (a)— 

7 (A) by striking ‘‘2013’’ and inserting 

8 ‘‘2018’’; and 

9 (B) by striking ‘‘Biosimilar User Fee Act of 

10 2012’’ and inserting ‘‘Biosimilar User Fee 

11 Amendments of 2017’’; 

12 (2) in subsection (b), by striking ‘‘2013’’ and in13 serting ‘‘2018’’; 

14 (3) by striking subsection (d); 

15 (4) by redesignating subsection (e) as subsection 

16 (d); and 

17 (5) in subsection (d), as so redesignated, by 

18 striking ‘‘2017’’ each place it appears and inserting 

19 ‘‘2022’’. 

20 SEC. 405. SUNSET DATES. 

21 (a) AUTHORIZATION.—Sections 744G and 744H of the 

22 Federal Food, Drug, and Cosmetic Act, as amended by sec23 tion 403 of this Act, shall cease to be effective October 1, 

24 2022. 


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1 (b) REPORTING REQUIREMENTS.—Section 744I of the 

2 Federal Food, Drug, and Cosmetic Act, as amended by sec3 tion 404 of this Act, shall cease to be effective January 31, 

4 2023. 

5 (c) PREVIOUS SUNSET PROVISION.— 

6 (1) IN GENERAL.—Effective October 1, 2017, sec7 tion 404 of the Food and Drug Administration Safety 

8 and Innovation Act (Public Law 112–144) is re9 pealed. 

10 (2) CONFORMING AMENDMENT.—The Food and 

11 Drug Administration Safety and Innovation Act 

12 (Public Law 112–144) is amended in the table of con13 tents in section 2 by striking the item relating to sec14 tion 404. 

15 SEC. 406. EFFECTIVE DATE. 

16 The amendments made by this title shall take effect 

17 on October 1, 2017, or the date of the enactment of this 

18 Act, whichever is later, except that fees under part 8 of sub19 chapter C of chapter VII of the Federal Food, Drug, and 

20 Cosmetic Act shall be assessed for all biosimilar biological 

21 product applications received on or after October 1, 2017, 

22 regardless of the date of the enactment of this Act. 

23 SEC. 407. SAVINGS CLAUSE. 

24 Notwithstanding the amendments made by this title, 

25 part 8 of subchapter C of chapter VII of the Federal Food, 


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1 Drug, and Cosmetic Act, as in effect on the day before the 

2 date of the enactment of this title, shall continue to be in 

3 effect with respect to biosimilar biological product applica4 tions and supplements (as defined in such part as of such 

5 day) that were accepted by the Food and Drug Administra6 tion for filing on or after October 1, 2012, but before October 

7 1, 2017, with respect to assessing and collecting any fee re8 quired by such part for a fiscal year prior to fiscal year 

9 2018. 

10 TITLE V—PEDIATRIC DRUGS 

11 AND DEVICES 

12 SEC. 501. PEDIATRIC DEVICES. 

13 (a) PEDIATRIC USE OF DEVICES.—Section 515A of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e– 

15 1) is amended— 

16 (1) in subsection (a)(3)— 

17 (A) by redesignating subparagraphs (B) 

18 through (D) as subparagraphs (D) through (F), 

19 respectively; 

20 (B) by inserting after subparagraph (A) the 

21 following: 

22 ‘‘(B) an assessment of pediatric device label23 ing needs based on a review of real world evi24 dence collected on the off-label use of medical deVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00162 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 vices in children, using data available to the 

2 Secretary; 

3 ‘‘(C) the number of devices that receive a 

4 humanitarian use exemption under section 

5 520(m);’’; 

6 (C) in subparagraph (E), as so redesig7 nated, by striking ‘‘; and’’ and inserting ‘‘;’’; 

8 (D) in subparagraph (F) (as so redesig9 nated), by striking ‘‘(B), and (C).’’ and inserting 

10 ‘‘(C), (D), and (E); and’’; and 

11 (E) by adding at the end the following: 

12 ‘‘(G) the number of devices for which ex13 trapolation was used to support the approval of 

14 pediatric labeling of such devices. 

15 For the items described in this paragraph, such report 

16 shall disaggregate the number of devices by pediatric 

17 subpopulation.’’; 

18 (2) by redesignating subsection (c) as subsection 

19 (d); and 

20 (3) by inserting after subsection (b), the fol21 lowing: 

22 ‘‘(c) PEDIATRIC DEVICE INNOVATION.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall, not 

24 later than 1 year after the date of enactment of the 

25 FDA Reauthorization Act of 2017, establish within 


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1 the Center for Devices and Radiological Health a 

2 structure to— 

3 ‘‘(A) provide assistance to device manufac4 turers that would result in the development, ap5 proval, and labeling of medical devices for chil6 dren; 

7 ‘‘(B) oversee an internal pediatrics team 

8 that— 

9 ‘‘(i) is comprised of employees of the 

10 Food and Drug Administration with exper11 tise in pediatrics and appropriate expertise 

12 pertaining to the relevant devices under re13 view; and 

14 ‘‘(ii) provides expertise and consulta15 tion, to all applicable divisions within the 

16 Center for Devices and Radiological Health, 

17 on— 

18 ‘‘(I) the application of subsection 

19 (b), section 520(m), section 510(k), and 

20 section 522 of this Act and section 402 

21 of the Public Health Service Act to pe22 diatric devices; and 

23 ‘‘(II) pediatrics, as it pertains to 

24 reviewing devices; 


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1 ‘‘(C) coordinate pediatric activities within 

2 the Center for Devices and Radiological Health; 

3 and 

4 ‘‘(D) collaborate with other programs, of5 fices, and centers of the Food and Drug Adminis6 tration, including the consortia program author7 ized under section 305 of the Pediatric Medical 

8 Device Safety and Improvement Act of 2007. 

9 ‘‘(2) STAFF.—Such structure shall include a 

10 chief pediatric medical officer and other appropriate 

11 individuals, as the Secretary determines necessary.’’. 

12 (b) HUMANITARIAN DEVICE EXEMPTION.—Section 

13 520(m) of the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 360j(m)) is amended— 

15 (1) in paragraph (4)— 

16 (A) in subparagraph (B), by inserting ‘‘or 

17 an appropriate local committee’’ after ‘‘review 

18 committee’’ each place such term appears; and 

19 (B) in the matter following subparagraph 

20 (B), by inserting ‘‘or an appropriate local com21 mittee’’ after ‘‘review committee’’ each place such 

22 term appears; and 

23 (2) in paragraph (6)(A)(iv), by striking ‘‘2017’’ 

24 and inserting ‘‘2022’’. 


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1 (c) DEMONSTRATION GRANTS FOR IMPROVING PEDI2 ATRIC AVAILABILITY.—Section 305 of the Pediatric Medical 

3 Device Safety and Improvement Act of 2007 (Public Law 

4 110–85; 42 U.S.C. 282 note) is amended— 

5 (1) in subsection (c)— 

6 (A) in paragraph (4), by striking ‘‘and’’ at 

7 the end; 

8 (B) in paragraph (5), by striking the period 

9 and inserting ‘‘; and’’; and 

10 (C) by adding at the end the following: 

11 ‘‘(6) providing regulatory consultation to device 

12 sponsors in support of the submission of an applica13 tion for a pediatric device, where appropriate.’’; and 

14 (2) in subsection (e), by striking ‘‘2017’’ and in15 serting ‘‘2022’’. 

16 (d) MEETING ON PEDIATRIC DEVICE DEVELOP17 MENT.— 

18 (1) IN GENERAL.—Not later than 1 year after 

19 the date of enactment of this Act, the Secretary of 

20 Health and Human Services shall convene a public 

21 meeting regarding opportunities and barriers to the 

22 development, approval, and labeling of pediatric med23 ical devices. Such meeting shall include representa24 tives from the medical device industry, academia, re25 cipients of funding under section 305 of the Pediatric 


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1 Medical Device Safety and Improvement Act of 2007 

2 (Public Law 110–85; 42 U.S.C. 282 note), medical 

3 provider organizations, and organizations rep4 resenting patients and consumers. 

5 (2) TOPICS.—The meeting described in para6 graph (1) shall include consideration of ways to— 

7 (A) improve research infrastructure and re8 search networks to facilitate the conduct of clin9 ical studies of devices for children that would re10 sult in the approval and labeling of medical de11 vices for children; 

12 (B) appropriately use extrapolation under 

13 section 515A(b) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 360e–1(b)); 

15 (C) enhance the appropriate use of 

16 postmarket registries and data to increase pedi17 atric medical device labeling; 

18 (D) increase Food and Drug Administra19 tion assistance to medical device manufactures 

20 in developing devices for children that are ap21 proved and labeled for their use; and 

22 (E) identify current barriers to pediatric 

23 device development and incentives to address 

24 such barriers. 


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1 (3) REPORT.—Not later than 6 months after the 

2 meeting described in paragraph (1), the Secretary of 

3 Health and Human Services shall submit to the Com4 mittee on Energy and Commerce of the House of Rep5 resentatives and the Committee on Health, Education, 

6 Labor, and Pensions of the Senate, and publish, in7 cluding on the Internet website of the Food and Drug 

8 Administration, a report that summarizes and re9 sponds to the recommendations raised in such meet10 ing. 

11 SEC. 502. PEDIATRIC DRUG DEVELOPMENT. 

12 (a) EARLY MEETING ON PEDIATRIC STUDY PLAN.— 

13 (1) IN GENERAL.—Clause (i) of section 

14 505B(e)(2)(C) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355c(e)(2)(C)) is amended to 

16 read as follows: 

17 ‘‘(i) shall meet with the applicant— 

18 ‘‘(I) if requested by the applicant 

19 with respect to a drug that is intended 

20 to treat a serious or life-threatening 

21 disease or condition, to discuss prepa22 ration of the initial pediatric study 

23 plan, not later than the end-of-Phase 1 

24 meeting (as such term is used in sec25 tion 312.82(b) of title 21, Code of FedVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00168 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 eral Regulations, or successor regula2 tions) or within 30 calendar days of 

3 receipt of such request, whichever is 

4 later; 

5 ‘‘(II) to discuss the initial pedi6 atric study plan as soon as practicable, 

7 but not later than 90 calendar days 

8 after the receipt of such plan under 

9 subparagraph (A); and 

10 ‘‘(III) to discuss any scientific or 

11 operational challenges that may be the 

12 basis of a deferral under subsection 

13 (a)(3) or a full or partial waiver under 

14 subsection (a)(4);’’. 

15 (2) CONFORMING CHANGES.—Section 505B(e) of 

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

17 355c(e)) is amended— 

18 (A) in the heading of paragraph (2), by 

19 striking ‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 

20 (B) in the heading of paragraph (2)(C), by 

21 striking ‘‘MEETING’’ and inserting ‘‘MEETINGS’’; 

22 (C) in clauses (ii) and (iii) of paragraph 

23 (2)(C), by striking ‘‘no meeting’’ each place it 

24 appears and inserting ‘‘no meeting under clause 

25 (i)(II)’’; and 


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1 (D) in paragraph (3) by striking ‘‘meeting 

2 under paragraph (2)(C)(i)’’ and inserting ‘‘meet3 ing under paragraph (2)(C)(i)(II)’’. 

4 (b) INFORMING INTERNAL REVIEW COMMITTEE.—Sec5 tion 505A(f) of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 355a(f)) is amended by adding at the end the 

7 following: 

8 ‘‘(7) INFORMING INTERNAL REVIEW COM9 MITTEE.—The Secretary shall provide to the com10 mittee referred to in paragraph (1) any response 

11 issued to an applicant or holder with respect to a 

12 proposed pediatric study request.’’. 

13 (c) ACTION ON SUBMISSIONS.— 

14 (1) IN GENERAL.—Section 505A(d) of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

16 355a(d)) is amended— 

17 (A) by redesignating paragraphs (3) 

18 through (5) as paragraphs (4) through (6), re19 spectively; and 

20 (B) by inserting after paragraph (2) the fol21 lowing: 

22 ‘‘(3) ACTION ON SUBMISSIONS.—The Secretary 

23 shall review and act upon a submission of a proposed 

24 pediatric study request or a sponsor’s proposed 


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1 amendment to a written request for pediatric studies 

2 within 120 calendar days of the submission.’’. 

3 (2) CONFORMING AMENDMENTS.— 

4 (A) FFDCA.—Section 505A of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 355a), 

6 as amended by paragraph (1), is further amend7 ed by striking subsection ‘‘(d)(3)’’ each place it 

8 appears and inserting ‘‘(d)(4)’’. 

9 (B) PHSA.—Paragraphs (2), (3), and (4) 

10 of section 351(m) of the Public Health Service 

11 Act (42 U.S.C. 262(m)) are amended by striking 

12 ‘‘section 505A(d)(3)’’ each place it appears and 

13 inserting ‘‘section 505A(d)(4)’’. 

14 (d) STUDY.—The Secretary of Health and Human 

15 Services, acting through the internal review committee es16 tablished under section 505C of the Federal Food, Drug, 

17 and Cosmetic Act (21 U.S.C. 355d) shall, not later than 

18 one year after the date of enactment of this Act, develop 

19 and implement a plan to achieve, when appropriate, earlier 

20 submission of pediatric studies under section 505A of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 

22 or section 351(m) of the Public Health Service Act (42 

23 U.S.C. 262(m)). Such plan shall include recommendations 

24 to achieve— 


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1 (1) earlier discussion of proposed pediatric study 

2 requests and written requests with sponsors, and if 

3 appropriate, at the meeting required under section 

4 505B(e)(2)(C) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355c(e)(2)(C)), as amended by 

6 subsection (a); 

7 (2) earlier issuance of written requests for a pe8 diatric study under such section 505A, including for 

9 investigational new drugs prior to the submission of 

10 an application under section 505(b)(1) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)); 

12 and 

13 (3) shorter timelines, when appropriate, for the 

14 completion of studies pursuant to a written request 

15 under such section 505A or such section 351(m). 

16 (e) NEONATOLOGY EXPERTISE.— 

17 (1) IN GENERAL.—Section 6(d) of the Best Phar18 maceuticals for Children Act (21 U.S.C. 393a(d)) is 

19 amended by striking ‘‘For the 5-year period begin20 ning on the date of enactment of this subsection, at’’ 

21 and inserting ‘‘At’’. 

22 (2) DRAFT GUIDANCE.—Not later than 2 years 

23 after the date of enactment of this Act, the Secretary 

24 shall issue draft guidance on clinical pharmacology 


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1 considerations for neonatal studies for drugs and bio2 logical products. 

3 (f) SUBMISSION OF ASSESSMENTS.—Section 

4 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 355c(d)(1)) is amended by adding at the end 

6 the following: ‘‘The Secretary shall inform the Pediatric Ad7 visory Committee of all letters and responses to such letters 

8 issued under this paragraph.’’. 

9 (g) INTERNAL COMMITTEE.—Section 505C of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355d) is 

11 amended by inserting ‘‘or pediatric rare diseases’’ after 

12 ‘‘psychiatry’’. 

13 SEC. 503. GUIDANCE ON MOLECULAR TARGETS IN PEDI14 ATRIC ONCOLOGY. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services (referred to in this section as the ‘‘Sec17 retary’’), acting through the Commissioner of Food and 

18 Drugs, shall issue guidance on the development of oncology 

19 drugs or biological products directed at molecular targets, 

20 including for pediatric populations. 

21 (b) COLLABORATION; PUBLIC MEETING.—In devel22 oping the guidance under subsection (a), the Secretary, act23 ing through the Commissioner of Food and Drugs and in 

24 collaboration with the Director of the National Cancer In25 stitute, shall convene a public meeting not later than 180 


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1 days after the date of enactment of this Act to solicit feed2 back from physicians and researchers (including pediatric 

3 oncologists), patients, and other stakeholders to provide 

4 input on development of the guidance. The Secretary shall 

5 seek input at such meeting on— 

6 (1) the scientific data necessary to determine 

7 when an oncology drug or biological product directed 

8 at a molecular target is sufficient to support pediatric 

9 clinical development given the ethical, practical, and 

10 other barriers to clinical investigations in the pedi11 atric population; 

12 (2) how to determine relevancy of a molecular 

13 target to the growth or progression of a pediatric can14 cer, including the clinical data necessary to make 

15 such a determination; 

16 (3) how to overcome the challenges related to pe17 diatric oncology drug development, including issues 

18 related to conducting clinical trials in pediatric rare 

19 cancers with small patient populations; 

20 (4) the advantages and disadvantages of innova21 tive clinical trial designs in addressing the develop22 ment of oncology drugs or biological products directed 

23 at molecular targets in pediatric cancer patients; and 

24 (5) the ways in which the Secretary can improve 

25 the current process outlined under sections 505A and 


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1 505B of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 355a, 355c) to encourage additional re3 search and development of pediatric cancer treat4 ments. 

5 SEC. 504. BEST PHARMACEUTICALS FOR CHILDREN. 

6 Section 409I of the Public Health Service Act (42 

7 U.S.C. 284m) is amended— 

8 (1) in subsection (a)(2)(A)(ii), by inserting ‘‘and 

9 identification of biomarkers for such diseases, dis10 orders, or conditions,’’ after ‘‘biologics,’’; 

11 (2) in subsection (c)— 

12 (A) in paragraph (6)(B)— 

13 (i) by striking ‘‘shall be assigned a 

14 docket number by the Commissioner of Food 

15 and Drugs’’ and inserting ‘‘, not later than 

16 90 days after submission, shall be posted on 

17 the Internet website of the Food and Drug 

18 Administration in an accessible manner’’; 

19 and 

20 (ii) by striking ‘‘become part of the 

21 docket file with respect to each of the drugs’’ 

22 and inserting ‘‘be posted on the Internet 

23 website of the Food and Drug Administra24 tion’’; and 

25 (B) in paragraph (7)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘submitted’’ and in3 serting ‘‘posted’’; and 

4 (ii) in subparagraph (C), by striking 

5 ‘‘(i) place’’ and all that follows through the 

6 period at the end and inserting ‘‘publish 

7 through posting on the Internet website of 

8 the Food and Drug Administration a sum9 mary of the report and a copy of any re10 quested labeling changes.’’; 

11 (3) by striking subsection (d); 

12 (4) by redesignating subsection (e) as subsection 

13 (d); and 

14 (5) in paragraph (1) of subsection (d), as so re15 designated, by striking ‘‘2013 through 2017’’ and in16 serting ‘‘2018 through 2022’’. 

17 TITLE VI—REAUTHORIZATIONS 

18 AND IMPROVEMENTS RE19 LATED TO DRUGS 

20 SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO 

21 EXCLUSIVITY OF CERTAIN DRUGS CON22 TAINING SINGLE ENANTIOMERS. 

23 Section 505(u)(4) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 355(u)(4)) is amended by striking 

25 ‘‘2017’’ and inserting ‘‘2022’’. 


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1 SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUB2 LIC-PRIVATE PARTNERSHIPS. 

3 Section 566(f) of the Federal Food, Drug, and Cos4 metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 

5 ‘‘2013 through 2017’’ and inserting ‘‘2018 through 2022’’. 

6 SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PRO7 GRAM. 

8 Section 5(c) of the Orphan Drug Act (21 U.S.C. 

9 360ee(c)) is amended by striking ‘‘2013 through 2017’’ and 

10 inserting ‘‘2018 through 2022’’. 

11 SEC. 604. GUIDANCE REGARDING BIOEQUIVALENCE. 

12 (a) IN GENERAL.—In accordance with subsection (b), 

13 the Secretary of Health and Human Services, acting 

14 through the Commissioner of Food and Drugs, shall issue 

15 product-specific guidance that— 

16 (1) applies to complex non-biologic drugs; and 

17 (2) outlines how to demonstrate bioequivalence to 

18 the reference drug, in order to facilitate generic devel19 opment for such drugs. 

20 (b) DEADLINE FOR ISSUING GUIDANCE.—After the 

21 date of enactment of this Act, the Secretary of Health and 

22 Human Services, acting through the Commissioner of Food 

23 and Drugs, shall publish a guidance, for each complex non24 biologic drug that is approved under section 505(b) of the 

25 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), 

26 not less than 2 years prior to the earliest date on which 


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1 an abbreviated new drug application may be submitted 

2 pursuant to section 505(j) of the Federal, Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355(c)) that references such drug. 

4 (c) APPLICABILITY.—This section applies to guidances 

5 for abbreviated new drug applications that reference new 

6 drug applications first approved on or after October 1, 

7 2017. 

8 SEC. 605. PATIENT EXPERIENCE DATA. 

9 Section 569C(c)(2)(A) of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is amended 

11 by striking ‘‘impact of such disease or condition, or a re12 lated therapy,’’ and inserting ‘‘physical and psychosocial 

13 impacts of such disease or condition, related therapy, or 

14 clinical investigation’’. 

15 SEC. 606. COMMUNICATIONS PLANS. 

16 Section 505–1(e)(3) of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 355–1(e)(3)) is amended— 

18 (1) in subparagraph (B), by striking ‘‘; or’’; 

19 (2) in subparagraph (C), by striking the period 

20 and inserting ‘‘; or’’; and 

21 (3) by adding at the end the following: 

22 ‘‘(D) disseminating information to health 

23 care providers about the meaning of terms re24 lated to drug formulations or properties that are 

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1 mation about the limitations or patient care im2 plications of such formulations or properties, 

3 and how such formulations or properties may be 

4 related to serious adverse drug events associated 

5 with use of the drug.’’. 

6 SEC. 607. PROTECTING AND STRENGTHENING THE DRUG 

7 SUPPLY CHAIN. 

8 (a) DIVERTED DRUGS.—Paragraph (1) of section 

9 801(d) of the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 381(d)) is amended— 

11 (1) by striking ‘‘(d)(1) Except as’’ and inserting 

12 ‘‘(d)(1)(A) Except as’’; and 

13 (2) by adding at the end the following: 

14 ‘‘(B) Except as authorized by the Secretary in the case 

15 of a drug that appears on the drug shortage list under sec16 tion 506E or in the case of importation pursuant to section 

17 804(j), no drug that is subject to section 503(b)(1) may be 

18 imported into the United States for commercial use if such 

19 drug is manufactured outside the United States, the manu20 facturer has not authorized the drug to be marketed in the 

21 United States, and the manufacturer has not caused the 

22 drug to be labeled to be marketed in the United States.’’. 

23 (b) COUNTERFEIT DRUGS.—Subsection (b) of section 

24 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

25 333) is amended by adding at the end the following: 


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1 ‘‘(8) Notwithstanding subsection (a), any person who 

2 violates section 301(i)(3) by selling or dispensing, or hold3 ing for sale or dispensing, a drug that is a counterfeit drug 

4 shall be fined under title 18, United States Code, impris5 oned for not more than 10 years, or both, unless the person 

6 acted in good faith and had no reason to believe the drug 

7 was a counterfeit drug.’’. 

8 SEC. 608. TECHNICAL CORRECTIONS. 

9 Section 527 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 360cc) is amended— 

11 (1) in subsection (a), in the matter following 

12 paragraph (2), by striking ‘‘such drug for such dis13 ease or condition’’ and inserting ‘‘the same drug for 

14 the same disease or condition’’; 

15 (2) in subsection (b)— 

16 (A) in the matter preceding paragraph (1), 

17 by striking ‘‘If an application’’ and all that fol18 lows through ‘‘such license if’’ and inserting 

19 ‘‘During the 7-year period described in sub20 section (a) for an approved application under 

21 section 505 or license under section 351 of the 

22 Public Health Service Act, the Secretary may 

23 approve an application or issue a license for a 

24 drug that is otherwise the same, as determined 


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1 by the Secretary, as the already approved drug 

2 for the same rare disease or condition if’’; 

3 (B) in paragraph (1), by striking ‘‘notice’’ 

4 and all that follows through ‘‘assure’’ and insert5 ing ‘‘of exclusive approval or licensure notice 

6 and opportunity for the submission of views, 

7 that during such period the holder of the exclu8 sive approval or licensure cannot ensure’’; and 

9 (C) in paragraph (2), by striking ‘‘such 

10 holder provides’’ and inserting ‘‘the holder pro11 vides’’; and 

12 (3) by adding at the end the following: 

13 ‘‘(c) CONDITION OF CLINICAL SUPERIORITY.— 

14 ‘‘(1) IN GENERAL.—If a sponsor of a drug that 

15 is designated under section 526 and is otherwise the 

16 same, as determined by the Secretary, as an already 

17 approved or licensed drug is seeking exclusive ap18 proval or exclusive licensure described in subsection 

19 (a) for the same rare disease or condition as the al20 ready approved drug, the Secretary shall require such 

21 sponsor, as a condition of such exclusive approval or 

22 licensure, to demonstrate that such drug is clinically 

23 superior to any already approved or licensed drug 

24 that is the same drug. 


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1 ‘‘(2) DEFINITION.—For purposes of paragraph 

2 (1), the term ‘clinically superior’ with respect to a 

3 drug means that the drug provides a significant 

4 therapeutic advantage over and above an already ap5 proved or licensed drug in terms of greater efficacy, 

6 greater safety, or by providing a major contribution 

7 to patient care. 

8 ‘‘(d) REGULATIONS.—The Secretary may promulgate 

9 regulations for the implementation of subsection (c). Until 

10 such time as the Secretary promulgates regulations in ac11 cordance with this subsection, any definitions set forth in 

12 regulations implementing this section that were promul13 gated prior to the date of enactment of the FDA Reauthor14 ization Act of 2017 shall continue to apply.’’. 

15 TITLE VII—DEVICE INSPECTION 

16 AND REGULATORY IMPROVE17 MENTS 

18 SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES. 

19 (a) IN GENERAL.—Section 510(h) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended— 

21 (1) by striking paragraph (2) and inserting the 

22 following: 

23 ‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 

24 ‘‘(A) IN GENERAL.—The Secretary, acting 

25 through one or more officers or employees duly 


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1 designated by the Secretary, shall inspect estab2 lishments described in paragraph (1) that are 

3 engaged in the manufacture, propagation, 

4 compounding, or processing of a device or devices 

5 (referred to in this subsection as ‘device establish6 ments’) in accordance with a risk-based schedule 

7 established by the Secretary. 

8 ‘‘(B) FACTORS AND CONSIDERATIONS.—In 

9 establishing the risk-based schedule under sub10 paragraph (A), the Secretary shall— 

11 ‘‘(i) apply, to the extent applicable for 

12 device establishments, the factors identified 

13 in paragraph (4); and 

14 ‘‘(ii) consider the participation of the 

15 device establishment, as applicable, in inter16 national device audit programs in which 

17 the United States participates or the United 

18 States recognizes.’’; and 

19 (2) in paragraph (4)— 

20 (A) in the matter preceding subparagraph 

21 (A), by striking ‘‘paragraph (3)’’ and inserting 

22 ‘‘paragraph (2) or (3)’’; and 

23 (B) in subparagraph (C), by inserting ‘‘or 

24 device’’ after ‘‘drug’’. 


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1 (b) FOREIGN INSPECTIONS.—Section 809(a)(1) of the 

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

3 384e(a)(1)) is amended by striking ‘‘section 510(h)(3)’’ and 

4 inserting ‘‘paragraph (2) or (3) of section 510(h)’’. 

5 SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS. 

6 (a) INSPECTION PROCEDURE.—Section 704 of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) is 

8 amended by adding at the end the following: 

9 ‘‘(h)(1) In the case of inspections that are not for-cause 

10 inspections, the Secretary shall review existing processes 

11 and standards for inspections of domestic and foreign device 

12 establishments, and update such processes and standards to 

13 ensure uniform processes and standards, with exceptions as 

14 appropriate. Such processes and standards shall include— 

15 ‘‘(A) announcing the inspection to the establish16 ment within a reasonable time before such inspection, 

17 which shall include notification to the owner, oper18 ator, or agent in charge of the establishment regard19 ing the type and nature of the inspection; 

20 ‘‘(B) providing a reasonable estimate of the time21 frame for the duration of the inspection, an oppor22 tunity for advancing communications between the of23 ficers or employees carrying out the inspection under 

24 subsection (a)(1) and the owner, operator, or agent in 

25 charge of the establishment concerning appropriate 


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1 working hours during the inspection, and, to the ex2 tent feasible, advance notice of records that will be re3 quested in order to expedite the inspection; and 

4 ‘‘(C) providing for requirements with respect to 

5 the frequency and conditions of communications dur6 ing the inspection with the owner, operator, or agent 

7 in charge of the establishment regarding inspection 

8 status, which may be recorded by either party with 

9 advance notice and mutual consent. 

10 ‘‘(2) Nothing in this subsection affects the authority 

11 of the Secretary to conduct inspections otherwise permitted 

12 under this Act in order to ensure compliance.’’. 

13 (b) REPORT RESPONSES.—Section 704(b) of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)) is 

15 amended— 

16 (1) by striking ‘‘Upon completion’’ and inserting 

17 ‘‘(1) Upon completion’’; and 

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

19 ‘‘(2) In the case of establishments registered under sec20 tion 510 that have received a report pursuant to paragraph 

21 (1), and for which the owner, operator, or agent in charge 

22 of such establishment submits a timely response to such re23 port that includes a request for feedback to the actions pro24 posed in such response, and which involves a public health 

25 priority, the Secretary shall provide nonbinding feedback 


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1 regarding such proposed actions within 45 days of receipt 

2 of such request.’’. 

3 (c) GUIDANCE.— 

4 (1) DRAFT GUIDANCE.—Not later than 1 year 

5 after the date of enactment of this Act, the Secretary 

6 of Health and Human Services shall issue draft guid7 ance that— 

8 (A) specifies how the Food and Drug Ad9 ministration will implement the process de10 scribed in subsection (h) of section 704 of the 

11 Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 374), as amended by this section, and the 

13 requirements described in subsection (b)(2) of 

14 such section; 

15 (B) provides standard methods for commu16 nications described in such subsections; 

17 (C) establishes standard timeframes over 

18 consecutive days applicable to both domestic and 

19 foreign inspections, to which each inspector shall 

20 adhere unless an investigator can identify to the 

21 establishment a reason that more time is needed; 

22 and 

23 (D) identifies practices for investigators and 

24 device establishments to facilitate the continuity 

25 of inspections. 


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1 (2) FINAL GUIDANCE.—Not later than 18 months 

2 after the close of the comment period on the draft 

3 guidance under paragraph (1), the Secretary shall 

4 issue final guidance consistent with such paragraph. 

5 SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM. 

6 Section 704(g)(11) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 374(g)(11)) is amended by striking 

8 ‘‘October 1, 2017’’ and inserting ‘‘October 1, 2022’’. 

9 SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR 

10 DEVICES. 

11 Subsection (e)(4) of section 801 of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amend13 ed— 

14 (1) by adding at the end the following: 

15 ‘‘(E)(i)(I) If the Secretary denies a request for certifi16 cation under subparagraph (A)(ii) with respect to a device 

17 manufactured in an establishment (foreign or domestic) 

18 registered under section 510, the Secretary shall provide in 

19 writing to the person seeking such certification the basis 

20 for such denial, and specifically identify the finding upon 

21 which such denial is based. 

22 ‘‘(II) If the denial of a request as described in sub23 clause (I) is based on grounds other than an injunction pro24 ceeding pursuant to section 302, seizure action pursuant 

25 to section 304, or a recall designated Class I or Class II 


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1 pursuant to part 7, title 21, Code of Federal Regulations, 

2 the Secretary shall provide a substantive summary of the 

3 specific grounds for noncompliance identified. 

4 ‘‘(III) With respect to a device manufactured in an 

5 establishment that has received a report under section 

6 704(b), the Secretary shall not deny a request for certifi7 cation with respect to a device pursuant to subparagraph 

8 (A)(ii) if the Secretary and the owner, operator, or agent 

9 in charge of such establishment have agreed to a plan of 

10 correction in response to such report. 

11 ‘‘(ii)(I) The Secretary shall provide a process for a per12 son who is denied a certification as described in clause 

13 (i)(I) to request a review that conforms to the standards 

14 of section 517A(b). 

15 ‘‘(II) Notwithstanding any previous review conducted 

16 pursuant to subclause (I), a person who has been denied 

17 a certification as described in clause (i)(I) may at any time 

18 request a review in order to present new information relat19 ing to actions taken by such person to address the reasons 

20 identified by the Secretary for the denial of certification, 

21 including evidence that corrective actions are being or have 

22 been implemented to address grounds for noncompliance 

23 identified by the Secretary. 

24 ‘‘(III) Not later than 1 year after date of enactment 

25 of the FDA Reauthorization Act of 2017, the Secretary shall 


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1 issue guidance providing for a process to carry out this sub2 paragraph. Not later than 1 year after the close of the com3 ment period for such guidance, the Secretary shall issue 

4 final guidance.’’; and 

5 (2) by moving the margins of subparagraphs (C) 

6 and (D) 4 ems to the left. 

7 SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION. 

8 Section 704(g) of the Federal Food, Drug and Cosmetic 

9 Act (21 U.S.C. 374) is amended by adding at the end the 

10 following: 

11 ‘‘(15) Notwithstanding any other provision of 

12 this subsection, for purposes of conducting inspections 

13 of establishments that manufacture, prepare, propa14 gate, compound, or process devices except types of de15 vices licensed under section 351 of the Public Health 

16 Service Act, which inspections are required under sec17 tion 510(h) or are inspections of such establishments 

18 required to register pursuant to section 510(i), the 

19 Secretary may recognize auditing organizations that 

20 are recognized by organizations established by govern21 ments to facilitate international harmonization. Noth22 ing in this paragraph affects the authority of the Sec23 retary to inspect any device establishment pursuant 

24 to this Act. Nothing in this paragraph affects the auVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00189 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 thority of the Secretary to determine the official clas2 sification of an inspection.’’. 

3 SEC. 706. NOTIFICATION OF GUIDANCE RELATED TO LAB4 DEVELOPED TESTS. 

5 Section 1143 of the Food and Drug Administration 

6 Safety and Innovation Act (Public Law 112–144) is 

7 amended— 

8 (1) in subsection (a), by striking ‘‘60’’ and in9 serting ‘‘90’’; and 

10 (2) in subsection (b), by striking ‘‘5’’ and insert11 ing ‘‘10’’. 

12 SEC. 707. DIAGNOSTIC IMAGING DEVICES INTENDED FOR 

13 USE WITH CONTRAST AGENTS. 

14 Section 520 of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 360j) is amended by adding at the end the 

16 following: 

17 ‘‘(p)(1) The Secretary may approve an application or 

18 supplement to an application under section 515 for an ap19 plicable medical imaging device, may make a substantial 

20 equivalence determination as to an applicable medical im21 aging device for which a report or a supplement to a report 

22 has been submitted under section 510(k), or may grant a 

23 request under section 513(f)(2) for an applicable medical 

24 imaging device if the requirements of this subsection and 

25 other applicable premarket requirements are met, and the 


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1 indications and conditions of use proposed in such applica2 tion or notification involve the use of a contrast agent that 

3 is not— 

4 ‘‘(A) in a concentration, rate of administration, 

5 or route of administration that is different from those 

6 described in the approved labeling of such contrast 

7 agent, unless the Secretary determines, based on infor8 mation contained in the application or report, that 

9 the difference does not adversely affect the safety or ef10 fectiveness of the contrast agent when used with the 

11 device; 

12 ‘‘(B) in a region, organ, or system of the body 

13 that is different from those described in the approved 

14 labeling of the contrast agent, unless the Secretary de15 termines, based on information contained in the de16 vice application, request, or report, that any dif17 ference does not affect the safety or effectiveness of the 

18 contrast agent when used with the device; 

19 ‘‘(C) in a patient population different from the 

20 patient population in the approved labeling for such 

21 contrast agent, unless the Secretary determines, based 

22 on information contained in the application or re23 port, that the difference does not adversely affect the 

24 safety or effectiveness of the contrast agent when used 

25 with the device; or 


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1 ‘‘(D) in an imaging modality, such as 

2 ultrasound, magnetic resonance, x-ray, fluorescent im3 aging technology, or diagnostic radiopharmaceutical4 based technology that is different from those described 

5 in the approved labeling of the contrast agent. 

6 ‘‘(2) An applicable medical imaging device that is eli7 gible for approval under section 515, clearance under sec8 tion 510(k), or classification under section 513(f)(2), or ap9 proval, clearance, or classification as described in para10 graph (1) shall be subject only to such requirements of this 

11 Act that are applicable to devices. 

12 ‘‘(3) An application under section 515, report under 

13 section 510(k), or classification under section 513(f)(2) for 

14 an applicable medical imaging device intended for use in 

15 conjunction with a contrast agent to which clause (ii) or 

16 (iii) of section 505(c)(3)(E) applies shall refer to such con17 trast agent in such application, report, or request by trade 

18 or brand name, rather than to the international nonpropri19 etary name. 

20 ‘‘(4) In conducting a review of an application or re21 port submitted for an applicable medical imaging device, 

22 the agency center charged with the premarket review of de23 vices center may consult with the agency center charged 

24 with the premarket review of drugs and biological products. 

25 ‘‘(5) For purposes of this subsection— 


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1 ‘‘(A) the term ‘applicable medical imaging de2 vice’ means a device intended to be used in conjunc3 tion with a contrast agent or class of contrast agents 

4 for a use that is not described in the indications and 

5 usage section of the approved labeling of such contrast 

6 agent or the approved labeling of any contrast agent 

7 in such class, as applicable; and 

8 ‘‘(B) the term ‘contrast agent’ means a drug that 

9 is approved under section 505 or licensed under sec10 tion 351 of the Public Health Service Act, is intended 

11 for use in conjunction with an applicable medical im12 aging device, and— 

13 ‘‘(i) is a diagnostic radiopharmaceutical, as 

14 defined in sections 315.2 and 601.30 of title 21, 

15 Code of Federal Regulations (or any successor 

16 regulations); or 

17 ‘‘(ii) is a diagnostic agent that improves the 

18 visualization of structure or function within the 

19 body by increasing the relative difference in sig20 nal intensity within the target tissue, structure, 

21 or fluid.’’. 

22 SEC. 708. DIAGNOSTIC CLARITY. 

23 Not later than 18 months after the date of enactment 

24 of this Act, the Secretary of Health and Human Services 

25 (referred to in this section as the ‘‘Secretary’’) shall update 


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1 guidance with respect to the circumstances under which re2 agents, new instruments, or new combinations of instru3 ments may be added to groups of instruments that have 

4 been cleared under section 510(k) of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 360(k)). The updated guidance 

6 shall provide standard definitions and describe procedures 

7 for sponsors seeking to add a new instrument, reagent, or 

8 combination of instruments to a cleared group of instru9 ments to submit information to the Secretary dem10 onstrating that the new reagent, new instrument, or new 

11 combination of instruments does not alter the assay’s per12 formance, as applicable. The Secretary shall consult with 

13 affected entities and other stakeholders in updating the 

14 guidance. 

15 SEC. 709. APPROPRIATE CLASSIFICATION OF DEVICE AC16 CESSORIES. 

17 Section 513(b)(9) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 360c(b)(9)) is amended— 

19 (1) by striking ‘‘(9) The Secretary’’ and insert20 ing ‘‘(9)(A) The Secretary’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(B) The classification of any accessory classified 

23 prior to December 13, 2016, based on the intended use or 

24 uses of such accessory, shall continue to apply, unless other25 wise determined by the Secretary under section 515(e)(1). 


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1 ‘‘(C)(i) If an accessory has been cleared or approved 

2 based on the classification of another device with which such 

3 accessory is intended to be used and the Secretary has estab4 lished a classification for such accessory based on the in5 tended use or uses of the accessory, in accordance with sub6 paragraph (A), the manufacturer of such accessory may 

7 identify the classification so established for such accessory 

8 in a written notification to the Secretary. 

9 ‘‘(ii) Unless the Secretary notifies a manufacturer 

10 within 30 calendar days of receipt of a written notification 

11 described in clause (i) that the Secretary does not agree that 

12 the classification identified in such written notification is 

13 appropriate for the accessory, the accessory shall be auto14 matically reclassified in accordance with the classification 

15 identified in such written notification. 

16 ‘‘(iii) A written notification that the Secretary dis17 agrees with the classification identified in a written notifi18 cation described in clause (ii) shall include a detailed de19 scription and justification for the determination to dis20 agree. 

21 ‘‘(D)(i) A manufacturer of an accessory that has not 

22 been classified by the Secretary based on the intended use 

23 or uses of the accessory as described in subparagraph (A), 

24 and for which the Secretary has not established a classifica25 tion for the accessory type as a stand-alone device, may subVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00195 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 mit to the Secretary a written recommendation for the ap2 propriate classification of such accessory based on its in3 tended use or uses. Such submission shall include such in4 formation to support the recommendation as the Secretary 

5 may require. 

6 ‘‘(ii) The Secretary shall respond to a submission 

7 under clause (i) within 60 calendar days of receiving the 

8 submission by approving or denying the recommended clas9 sification of the accessory. If the Secretary does not agree 

10 with the recommendation for classification submitted by the 

11 sponsor, the response shall include a detailed description 

12 and justification for such determination to disagree. The 

13 Secretary shall provide an opportunity for a manufacturer 

14 to meet with appropriate personnel to discuss appropriate 

15 classification of such accessory prior to submitting a writ16 ten recommendation. 

17 ‘‘(E)(i) At the time a sponsor submits an application 

18 for premarket approval pursuant to section 515(c) or a re19 port pursuant to 510(k), the sponsor of such application 

20 or report may include a recommendation and supporting 

21 information for the proper classification of an accessory 

22 pursuant to subparagraph (A), if applicable. If such acces23 sory type has not been classified by the Secretary based on 

24 its intended use or uses as a stand-alone device as described 

25 in subparagraph (A), the Secretary shall— 


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1 ‘‘(I) approve or deny such application pursuant 

2 to section 515(d), or find such report substantially 

3 equivalent or not substantially equivalent pursuant to 

4 section 510(k); and 

5 ‘‘(II) approve or deny the classification of the ac6 cessory proposed in such application or report. 

7 ‘‘(F) A manufacturer may at any time use the classi8 fication process described in section 513(f)(2) to obtain clas9 sification of an accessory.’’. 

10 SEC. 710. DEVICE PILOT PROJECTS. 

11 (a) POSTMARKET PILOT.—Section 519 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended 

13 by adding at the end the following: 

14 ‘‘(i) PILOT PROJECTS.— 

15 ‘‘(1) IN GENERAL.—In order to provide timely 

16 and reliable information on the safety and effective17 ness of cleared or approved devices, including re18 sponses to adverse events and malfunctions, and to 

19 advance the objectives of part 803 of title 21, Code of 

20 Federal Regulations (or successor regulations), and 

21 advance the objectives of, and evaluate innovative new 

22 methods of compliance with, this section and section 

23 522, the Secretary shall, within one year of the date 

24 of enactment of the FDA Reauthorization Act of 2017, 

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1 ticipation by a manufacturer or manufacturers of de2 vice or device type, or continue existing projects, in 

3 accordance with paragraph (3), that meet all of the 

4 following requirements: 

5 ‘‘(A) Are designed to efficiently generate re6 liable and timely safety and active surveillance 

7 data for use by the Secretary or manufacturers 

8 of the devices that are involved in the pilot 

9 project. 

10 ‘‘(B) Inform the development of methods, 

11 systems, data criteria, and programs that could 

12 be used to support safety and active surveillance 

13 activities for devices not included in such project. 

14 ‘‘(C) Are designed and conducted in coordi15 nation with a comprehensive system for evalu16 ating medical device technology that operates 

17 under a governing board with appropriate rep18 resentation of stakeholders, including consumer 

19 groups and device manufacturers. 

20 ‘‘(D) Use electronic health data including 

21 claims data, patient survey data, and any other 

22 data, as the Secretary determines appropriate. 

23 ‘‘(E) Prioritize devices and device types 

24 that meet one or more of the following criteria: 


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1 ‘‘(i) Devices and device types for which 

2 the collection and analysis of real world evi3 dence regarding a device’s safety and effec4 tiveness is likely to advance public health. 

5 ‘‘(ii) Devices and device types that are 

6 widely used. 

7 ‘‘(iii) Devices and device types, the 

8 failure of which has significant health con9 sequences. 

10 ‘‘(iv) Devices and device types for 

11 which the Secretary has received public rec12 ommendations in accordance with para13 graph (2)(B) and has determined to meet 

14 one of the criteria under clauses (i) through 

15 (iii) and is appropriate for a project under 

16 this subsection. 

17 ‘‘(2) PARTICIPATION.—The Secretary shall estab18 lish the conditions and processes for— 

19 ‘‘(A) authorizing voluntary participation of 

20 a manufacturer of a device in the pilot project 

21 described in paragraph (1); and 

22 ‘‘(B) facilitating public recommendations 

23 for devices to be prioritized under the pilot 

24 project described in paragraph (1), including reVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00199 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 quirements for the data necessary to support 

2 such recommendation. 

3 ‘‘(3) IMPLEMENTATION.—The Secretary may sat4 isfy the requirements of paragraphs (1) and (2) by 

5 continuing or expanding existing projects, or by be6 ginning new projects, that meet the criteria of sub7 paragraphs (A) through (E) of paragraph (1) or by 

8 entering into contracts, cooperative agreements, 

9 grants, or other appropriate agreements with public 

10 or private entities that have a significant presence in 

11 the United States, and meet the following additional 

12 conditions: 

13 ‘‘(A) If such public or private entities are a 

14 component of another organization, the entities 

15 have established appropriate security measures 

16 to maintain the confidentiality and privacy of 

17 the data described in paragraph (1)(D) and the 

18 entity shall not make an unauthorized disclosure 

19 of such data to the other components of the orga20 nization in breach of such confidentiality and 

21 privacy requirements. 

22 ‘‘(B) In the case of the termination or non23 renewal of such contracts, cooperative agree24 ments, grants, or other appropriate agreements, 


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1 the entities shall comply with each of the fol2 lowing: 

3 ‘‘(i) Continue to comply with the con4 fidentiality and privacy requirements under 

5 this subsection with respect to all data dis6 closed to the entity. 

7 ‘‘(ii) Return any data disclosed to such 

8 entity under this subsection to which it 

9 would not otherwise have access or, if re10 turning the data is not practicable, destroy 

11 the data. 

12 ‘‘(C) Have at least one of the following 

13 qualifications: 

14 ‘‘(i) Research, statistical, epidemio15 logic, or clinical capability and expertise to 

16 conduct and complete the activities under 

17 this subsection, including the capability and 

18 expertise to provide the Secretary access to 

19 de-identified data consistent with the re20 quirements of this subsection. 

21 ‘‘(ii) An information technology infra22 structure in place to support electronic data 

23 and operational standards to provide secu24 rity for such data, as appropriate. 


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1 ‘‘(iii) Experience with, and expertise 

2 on, the development of device safety and ef3 fectiveness research and surveillance using 

4 electronic health data. 

5 ‘‘(iv) Other expertise which the Sec6 retary determines necessary to fulfill the ac7 tivities under this subsection. 

8 ‘‘(4) REVIEW OF CONTRACT IN THE EVENT OF A

9 MERGER OR ACQUISITION.—The Secretary shall re10 view a contract with a qualified entity under this 

11 subsection in the event of a merger or acquisition of 

12 the entity in order to ensure that the requirements 

13 under this subsection will continue to be met. 

14 ‘‘(5) REPORT TO CONGRESS.—Not later than 18 

15 months after the date of enactment of the FDA Reau16 thorization Act of 2017, and annually thereafter, the 

17 Secretary shall submit to the Committee on Health, 

18 Education, Labor, and Pensions of the Senate and the 

19 Committee on Energy and Commerce of the House of 

20 Representatives a report containing a description of 

21 the pilot projects being conducted pursuant to this 

22 subsection, including for each pilot project— 

23 ‘‘(A) how the project is being implemented 

24 in accordance with paragraph (3) and the con25 tractor or grantee as applicable; 


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1 ‘‘(B) the number of manufacturers that have 

2 agreed to participate; 

3 ‘‘(C) the data sources used; 

4 ‘‘(D) the devices or device categories in5 volved; and 

6 ‘‘(E) the number of patients involved. 

7 ‘‘(6) COMPLIANCE WITH REQUIREMENTS FOR

8 RECORDS OR REPORTS ON DEVICES.—The participa9 tion of a manufacturer in a pilot project under this 

10 subsection shall not affect the eligibility of such man11 ufacturer to participate in any quarterly reporting 

12 program implemented under this Act. The Secretary 

13 may determine that, for the specified time period to 

14 be determined by the Secretary, a manufacturer’s 

15 participation in a pilot project under this subsection 

16 may meet certain other requirements of this section or 

17 section 522 if— 

18 ‘‘(A) the project has demonstrated success in 

19 capturing relevant adverse event information; 

20 and 

21 ‘‘(B) the Secretary has established proce22 dures for making adverse event and safety infor23 mation collected from the pilot public, to the ex24 tent possible, if collected pursuant to this section 

25 or section 522. 


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1 ‘‘(7) PRIVACY REQUIREMENTS.—With respect to 

2 the pilot projects conducted pursuant to this sub3 section— 

4 ‘‘(A) individual identifiable health informa5 tion shall not be disclosed when presenting any 

6 information from such project; and 

7 ‘‘(B) such projects shall comply with section 

8 264(c) of the Health Insurance Portability and 

9 Accountability Act of 1996 (42 U.S.C. 1320d–2 

10 note) and sections 552 and 552a of title 5, 

11 United States Code. 

12 ‘‘(8) OTHER COMPLIANCE.—Any pilot program 

13 undertaken in coordination with the comprehensive 

14 system described in paragraph (1)(C), including pilot 

15 projects under this subsection, that relates to the use 

16 of real world evidence for devices shall comply with 

17 paragraph (1)(B), the conditions listed in subpara18 graphs (A) and (B) of paragraph (3), and para19 graphs (4), (5), (6), and (7). 

20 ‘‘(9) SUNSET.—This subsection shall cease to 

21 have force or effect on October 1, 2022.’’. 

22 (b) REPORT.—Not later than January 31, 2021, the 

23 Secretary of Health and Human Services, acting through 

24 the Commissioner of Food and Drugs, shall conduct a re25 view through an independent third party to evaluate the 


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1 strengths, limitations, and appropriate use of evidence col2 lected pursuant to real world evidence pilot projects de3 scribed in the letters described in section 201(b) of the Med4 ical Device User Fee Amendments of 2017 and subsection 

5 (i) of section 519 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360i), as amended by subsection (a), for in7 forming premarket and postmarket decisionmaking for 

8 multiple device types, and to determine whether the meth9 ods, systems, and programs in such pilot projects efficiently 

10 generate reliable and timely evidence about the effectiveness 

11 or safety surveillance of devices. 

12 SEC. 711. REGULATION OF OVER-THE-COUNTER HEARING 

13 AIDS. 

14 (a) IN GENERAL.—Section 520 of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by 

16 section 707, is further amended by adding at the end the 

17 following: 

18 ‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING

19 AIDS.— 

20 ‘‘(1) DEFINITION.—In this subsection, the term 

21 ‘over-the-counter hearing aid’ means a device that— 

22 ‘‘(A) uses the same fundamental scientific 

23 technology as air conduction hearing aids (as de24 fined in section 874.3300 of title 21, Code of 

25 Federal Regulations) (or any successor regulaVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00205 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 tion) or wireless air conduction hearing aids (as 

2 defined in section 874.3305 of title 21, Code of 

3 Federal Regulations) (or any successor regula4 tion); 

5 ‘‘(B) is intended to be used by adults over 

6 the age of 18 to compensate for perceived mild to 

7 moderate hearing impairment; 

8 ‘‘(C) through tools, tests, or software, allows 

9 the user to control the over-the-counter hearing 

10 aid and customize it to the user’s hearing needs; 

11 ‘‘(D) may— 

12 ‘‘(i) use wireless technology; or 

13 ‘‘(ii) include tests for self-assessment of 

14 hearing loss; and 

15 ‘‘(E) is available over-the-counter, without 

16 the supervision, prescription, or other order, in17 volvement, or intervention of a licensed person, 

18 to consumers through in-person transactions, by 

19 mail, or online. 

20 ‘‘(2) REGULATION.—An over-the-counter hearing 

21 aid shall be subject to the regulations promulgated in 

22 accordance with section 711(b) of the FDA Reauthor23 ization Act of 2017 and shall be exempt from sections 

24 801.420 and 801.421 of title 21, Code of Federal Reg25 ulations (or any successor regulations).’’. 


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1 (b) REGULATIONS TO ESTABLISH CATEGORY.— 

2 (1) IN GENERAL.—The Secretary of Health and 

3 Human Services (referred to in this section as the 

4 ‘‘Secretary’’), not later than 3 years after the date of 

5 enactment of this Act, shall promulgate proposed reg6 ulations to establish a category of over-the-counter 

7 hearing aids, as defined in subsection (q) of section 

8 520 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 360j) as amended by subsection (a), and, not 

10 later than 180 days after the date on which the public 

11 comment period on the proposed regulations closes, 

12 shall issue such final regulations. 

13 (2) REQUIREMENTS.—In promulgating the regu14 lations under paragraph (1), the Secretary shall— 

15 (A) include requirements that provide rea16 sonable assurances of the safety and efficacy of 

17 over-the-counter hearing aids; 

18 (B) include requirements that establish or 

19 adopt output limits appropriate for over-the20 counter hearing aids; 

21 (C) include requirements for appropriate la22 beling of the over-the-counter hearing aid, in23 cluding how consumers may report adverse 

24 events, any conditions or contraindications, and 


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1 any advisements to consult promptly with a li2 censed physician; and 

3 (D) describe the requirements under which 

4 the sale of over-the-counter hearing aids is per5 mitted, without the supervision, prescription, or 

6 other order, involvement, or intervention of a li7 censed person, to consumers through in-person 

8 transactions, by mail, or online. 

9 (3) PREMARKET NOTIFICATION.—The Secretary 

10 shall make findings under section 510(m) of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

12 360(m)) to determine whether over-the-counter hear13 ing aids (as defined in section 520(q) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as 

15 amended by subsection (a)) require a report under 

16 section 510(k) to provide reasonable assurance of safe17 ty and effectiveness. 

18 (4) EFFECT ON STATE LAW.—No State or local 

19 government shall establish or continue in effect any 

20 law, regulation, or order specifically applicable to 

21 hearing products that would restrict or interfere with 

22 the servicing, marketing, sale, dispensing, use, cus23 tomer support, or distribution of over-the-counter 

24 hearing aids (as defined in section 520(q) of the Fed25 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360j), 


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1 as amended by subsection (a)) through in-person 

2 transactions, by mail, or online, that is different 

3 from, in addition to, or otherwise not identical to, the 

4 regulations promulgated under this subsection, in5 cluding any State or local requirement for the super6 vision, prescription, or other order, involvement, or 

7 intervention of a licensed person for consumers to ac8 cess over-the-counter hearing aids. 

9 (c) NEW GUIDANCE ISSUED.—Not later than the date 

10 on which final regulations are issued under subsection (b), 

11 the Secretary shall update and finalize the draft guidance 

12 of the Department of Health and Human Services entitled, 

13 ‘‘Regulatory Requirements for Hearing Aid Devices and 

14 Personal Sound Amplification Products’’, issued on Novem15 ber 7, 2013. Such updated and finalized guidance shall 

16 clarify which products, on the basis of claims or other mar17 keting, advertising, or labeling material, meet the definition 

18 of a device in section 201 of the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 321) and which products meet the 

20 definition of a personal sound amplification product, as set 

21 forth in such guidance. 

22 (d) STUDY.—Not later than 3 years after the date of 

23 enactment of this Act, the Comptroller General of the United 

24 States shall submit to Congress a report evaluating con25 sumer experience with hearing health care, hearing screenVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00209 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 ing in the primary care setting, and consumer adoption, 

2 usage, and outcomes related to hearing technology. The 

3 Comptroller General shall update such report not later than 

4 2 years after the final regulations described in subsection 

5 (b) are issued, and shall evaluate how implementation of 

6 such regulations has impacted hearing health care, includ7 ing recommendations for improving consumer access to ap8 propriate hearing health care. 

9 TITLE VIII—ADDITIONAL 

10 PROVISIONS 

11 SEC. 801. GAO REPORT. 

12 (a) IN GENERAL.—Not later than September 30, 2018, 

13 the Comptroller General of the United States shall issue a 

14 report, after consultation with patients and drug and med15 ical device manufacturers, regarding the implementation of 

16 sections 569A and 569B of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 360bbb–8a, 360bbb–8b). Such re18 port shall assess the progress the Food and Drug Adminis19 tration has made on— 

20 (1) working with other regulatory authorities of 

21 similar standing to foster and encourage uniform, sci22 entifically driven clinical trial standards with respect 

23 to medical products around the world; 

24 (2) providing consistent parallel scientific advice 

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1 ment and approval of new medical products, in co2 ordination with regulatory authorities of similar 

3 standing; and 

4 (3) facilitating the use of foreign clinical trial 

5 data to minimize duplicative clinical trials. 

6 (b) ADDITIONAL REQUIREMENTS.—The report under 

7 subsection (a) shall include specific examples, if possible 

8 and available, and a list of activities at the Food and Drug 

9 Administration regarding the harmonization of premarket 

10 medical product requirements. 

11 SEC. 802. STREAMLINING AND IMPROVING CONSISTENCY IN 

12 PERFORMANCE REPORTING. 

13 (a) PDUFA.—Section 736B(a) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)) is amend15 ed— 

16 (1) in paragraph (1)(B)— 

17 (A) in clause (vi), by inserting ‘‘and the 

18 number of designations and denials issued by the 

19 agency for such applications’’ before the semi20 colon; 

21 (B) in clause (vii), by striking ‘‘; and’’ and 

22 inserting ‘‘and the number of designations and 

23 denials issued by the agency for such applica24 tions; and’’; and 


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1 (C) in clause (viii) by striking the period 

2 and inserting ‘‘and the number of designations 

3 and denials issued by the agency for such appli4 cations.’’; and 

5 (2) by inserting after paragraph (2) the fol6 lowing: 

7 ‘‘(3) REAL TIME REPORTING.— 

8 ‘‘(A) IN GENERAL.—Beginning with fiscal 

9 year 2018, every 30 calendar days, the Secretary 

10 shall post the data described in subparagraph 

11 (B) on the Internet website of the Food and Drug 

12 Administration and remove duplicative data 

13 from the annual performance report. 

14 ‘‘(B) DATA.—The following data is required 

15 to be posted in accordance with subparagraph 

16 (A): 

17 ‘‘(i) The number and titles of draft and 

18 final guidance issued by the Center for 

19 Drug Evaluation and Research or the Cen20 ter for Biologics Evaluation and Research, 

21 and the justification for the issuance and fi22 nalization of each such guidance. 

23 ‘‘(ii) The number and titles of public 

24 meetings held by the Center for Drug Eval25 uation and Research and the Center for 


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1 Biologics Evaluation and Research each fis2 cal year. 

3 ‘‘(iii) The list of standard new drug 

4 applications and biologics license applica5 tions, by fiscal year of receipt. 

6 ‘‘(iv) The number of filed applications 

7 by each review division. 

8 ‘‘(4) CAPACITY PLANNING AND IMPROVED TIME

9 REPORTING.—Beginning with fiscal year 2020, the 

10 Secretary shall include in the annual report under 

11 paragraph (1)— 

12 ‘‘(A) the number of full-time equivalents 

13 agreed upon in the letters described in section 

14 101(b) of the Prescription Drug User Fee 

15 Amendments of 2017 and the number of appro16 priated full time equivalents at the Food and 

17 Drug Administration by each division within the 

18 Center for Drug Evaluation and Research, the 

19 Center for Biologics Evaluation and Research, 

20 the Office of Regulatory Affairs, and the Office 

21 of the Commissioner; 

22 ‘‘(B) identification by name of all time re23 porting categories that Food and Drug Adminis24 tration uses for capacity planning and time re25 porting with respect to the Center for Drug EvalVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00213 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 uation and Research, the Center for Biologics 

2 Evaluation and Research, the Office of Regu3 latory Affairs, and the Office of the Commis4 sioner, pursuant to the ‘resource capacity plan5 ning and modernized time reporting implemen6 tation plan’ in the letters described in section 

7 101(b) of the Prescription Drug User Fee 

8 Amendments of 2017; 

9 ‘‘(C) the processes by which the Center for 

10 Drug Evaluation and Research, the Center for 

11 Biologics Evaluation and Research, the Office of 

12 Regulatory Affairs, and the Office of the Com13 missioner require reporting on the amount of an 

14 employee’s time that is dedicated to the review of 

15 human drug applications, as required by the let16 ters described in section 101(b) of the Prescrip17 tion Drug User Fee Amendments of 2017, in18 cluding information regarding employees dedi19 cated to such activities on a full-time basis, and 

20 employees dedicated to such activities on a part21 time basis; and 

22 ‘‘(D) for each of the Center for Drug Eval23 uation and Research, the Center for Biologics 

24 Evaluation and Research, the Office of Regu25 latory Affairs, and the Office of the CommisVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00214 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 sioner, the number of employees described in sub2 paragraph (C) (both full-time equivalents and 

3 employees dedicated to such activities on a part4 time basis) for whom time reporting is required 

5 as described in subparagraph (C), and the num6 ber of such employees required to estimate time 

7 dedicated to the review of human drug applica8 tions.’’. 

9 (b) MDUFA.—Section 738A(a)(1)(A) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)) 

11 is amended— 

12 (1) by striking ‘‘Beginning with’’ and inserting 

13 the following: 

14 ‘‘(i) GENERAL REQUIREMENTS.—Be15 ginning with’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(ii) ADDITIONAL INFORMATION.—Be18 ginning with fiscal year 2018, the annual 

19 report under this subparagraph shall in20 clude the progress of the Center for Devices 

21 and Radiological Health in achieving the 

22 goals, and future plans for meeting the 

23 goals, including, for each review division— 

24 ‘‘(I) the number of premarket ap25 plications filed under section 515 per 


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1 fiscal year for each review division, 

2 and the number of approvable letters, 

3 major deficiency letters, not approvable 

4 letters, and denials for such applica5 tions; 

6 ‘‘(II) the number of reports filed 

7 under section 510(k) per fiscal year for 

8 each review division and the number of 

9 devices cleared or not substantially 

10 equivalent for such reports; and 

11 ‘‘(III) the number of expedited ac12 cess pathway designations for a fiscal 

13 year for each review division and the 

14 number of cleared or approved devices 

15 or denials for such applications. 

16 ‘‘(iii) REAL TIME REPORTING.— 

17 ‘‘(I) IN GENERAL.—Beginning 

18 with fiscal year 2018, the Secretary 

19 shall, every 30 calendar days, post the 

20 data described in subclause (II) on the 

21 Internet website of the Food and Drug 

22 Administration and remove duplicative 

23 data from the annual report under this 

24 subparagraph. 


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1 ‘‘(II) DATA.—The following data 

2 is required to be posted in accordance 

3 with subclause (I): 

4 ‘‘(aa) The number and titles 

5 of draft and final guidance issued 

6 by the Center for Devices and Ra7 diological Health and the jus8 tification for the issuance and fi9 nalization of such guidance. 

10 ‘‘(bb) The number and titles 

11 of public meetings held by the 

12 Center for Devices and Radio13 logical Health each fiscal year.’’. 

14 (c) GDUFA.—Section 744C(a) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)) is amend16 ed— 

17 (1) by striking ‘‘Beginning with’’ and inserting 

18 the following: 

19 ‘‘(1) GENERAL REQUIREMENTS.—Beginning 

20 with’’; and 

21 (2) by adding at the end the following: 

22 ‘‘(2) ADDITIONAL INFORMATION.—Beginning 

23 with fiscal year 2018, the report under this subsection 

24 shall include the progress of the Office of Generic 


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1 Drugs in achieving the goals, and future plans for 

2 meeting the goals, including— 

3 ‘‘(A) the number of original abbreviated 

4 new drug applications filed per fiscal year; 

5 ‘‘(B) the number of amendments to abbre6 viated new drug applications filed per fiscal 

7 year; and 

8 ‘‘(C) the number of actions taken delineated 

9 by the type of action, including final approvals, 

10 tentative approvals, complete response letters, 

11 and the number of ‘refuse to receive’ letters 

12 issued by the Food and Drug Administration per 

13 fiscal year. 

14 ‘‘(3) REAL TIME REPORTING.— 

15 ‘‘(A) IN GENERAL.—Beginning with fiscal 

16 year 2018, the Secretary shall, every 30 calendar 

17 days, post the data described in subparagraph 

18 (B) on the Internet website of the Food and Drug 

19 Administration and remove duplicative data 

20 from the annual report under this subsection. 

21 ‘‘(B) DATA.—The following data is required 

22 to be posted in accordance with subparagraph 

23 (A): 

24 ‘‘(i) The number and titles of draft and 

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1 neric Drugs and the justification for the 

2 issuance and finalization of such guidance. 

3 ‘‘(ii) The number and titles of public 

4 meetings held by the Office of Generic Drugs 

5 each fiscal year.’’. 

6 (d) BsUFA.—Section 744I(a) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)) is amend8 ed— 

9 (1) by striking ‘‘Beginning with’’ and inserting 

10 the following: 

11 ‘‘(1) GENERAL REQUIREMENTS.—Beginning 

12 with’’; and 

13 (2) by adding at the end the following: 

14 ‘‘(2) ADDITIONAL INFORMATION.—Beginning 

15 with fiscal year 2018, the report under this subsection 

16 shall include the progress of the Center for Biologics 

17 Evaluation and Research in achieving the goals, and 

18 future plans for meeting the goals, including— 

19 ‘‘(A) information on all previous cohorts for 

20 which the Secretary has not given a complete re21 sponse on all biosimilar biological product appli22 cations and supplements in the cohort; 

23 ‘‘(B) the number of original biosimilar bio24 logical product applications filed per fiscal year, 

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1 sponse letters issued by the agency for such ap2 plications; and 

3 ‘‘(C) the number of resubmitted original 

4 biosimilar biological product applications filed 

5 per fiscal year and the number of approvals or 

6 complete response letters issued by the agency for 

7 such applications. 

8 ‘‘(3) REAL TIME REPORTING.— 

9 ‘‘(A) IN GENERAL.—Beginning with fiscal 

10 year 2018, the Secretary shall, every 30 calendar 

11 days, post the data described in subparagraph 

12 (B) on the Internet website of the Food and Drug 

13 Administration and remove duplicative data 

14 from the annual report under this subsection. 

15 ‘‘(B) DATA.—The following data is required 

16 to be posted in accordance with subparagraph 

17 (A): 

18 ‘‘(i) The number and titles of draft and 

19 final guidance issued by the Center for 

20 Drug Evaluation and Research and the 

21 Center for Biologics Evaluation and Re22 search and the justification for the issuance 

23 and finalization of such guidance. 

24 ‘‘(ii) The number and titles of public 

25 meetings held by the Center for Drug EvalVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00220 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 uation and Research and the Center for 

2 Biologic Evaluation and Research each fis3 cal year.’’. 

4 ‘‘(4) CAPACITY PLANNING AND TIME REPORT5 ING.—Beginning with fiscal year 2020, the Secretary 

6 shall include in the annual report under paragraph 

7 (1)— 

8 ‘‘(A) the number of full-time equivalents 

9 agreed upon in the letters described in section 

10 401(b) of the Biosimilar User Fee Amendments 

11 of 2017 and the number of appropriated full 

12 time equivalents at the Food and Drug Adminis13 tration by each division within the Center for 

14 Drug Evaluation and Research, the Center for 

15 Biologics Evaluation and Research, the Office of 

16 Regulatory Affairs, and the Office of the Com17 missioner; 

18 ‘‘(B) identification by name of all time re19 porting categories that the Food and Drug Ad20 ministration uses for capacity planning and 

21 time reporting under the ‘resource capacity plan22 ning and modernized time reporting implemen23 tation plan’ in the letters described in section 

24 401(b) of the Biosimilar User Fee Amendments 

25 of 2017 for the Center for Drug Evaluation and 


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1 Research, the Center for Biologics Evaluation 

2 and Research, the Office of Regulatory Affairs 

3 and the Office of the Commissioner; 

4 ‘‘(C) the process by which the Center for 

5 Drug Evaluation and Research, the Center for 

6 Biologics Evaluation and Research, the Office of 

7 Regulatory Affairs, and the Office of the Com8 missioner require reporting on the amount of an 

9 employee’s time that is dedicated to the review of 

10 biosimilar biological product applications, re11 quired pursuant to the letters described in sec12 tion 401(b) of the Biosimilar User Fee Amend13 ments of 2017, including information regarding 

14 both employees dedicated to such activities on a 

15 full-time basis, and employees dedicated to such 

16 activities on a part-time basis; and 

17 ‘‘(D) for each of the Center for Drug Eval18 uation and Research, the Center for Biologics 

19 Evaluation and Research, the Office of Regu20 latory Affairs, and the Office of the Commis21 sioner, the actual number of employees described 

22 in subparagraph (C) (both full-time equivalents 

23 and employees dedicated to such activities on a 

24 part-time basis) for whom time reporting is re25 quired as described in subparagraph (C), and the 


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1 number of such employees required to estimate 

2 time dedicated to the review of biosimilar bio3 logical product applications.’’. 

4 SEC. 803. ANALYSIS OF USE OF FUNDS. 

5 (a) PDUFA REPORTS.— 

6 (1) ANALYSIS IN PDUFA PERFORMANCE RE7 PORTS.—Section 736B(a) of the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 379h–2(a)), as amended 

9 by section 802(a), is further amended by adding at 

10 the end the following: 

11 ‘‘(5) ANALYSIS.—For each fiscal year, the Sec12 retary shall include in the report under paragraph 

13 (1) an analysis of the following: 

14 ‘‘(A) The difference between the number of 

15 human drug applications filed and the number 

16 of approvals or complete response letters issued 

17 by the agency, accounting for— 

18 ‘‘(i) such applications filed during one 

19 fiscal year for which a decision is not sched20 uled to be made until the following fiscal 

21 year; 

22 ‘‘(ii) such applications pending with 

23 the Center for Drug Evaluation and Re24 search and the Center for Biologics Evalua25 tion and Research that did not meet the 


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1 goals identified in the letters described in 

2 section 101(b) of the Prescription Drug 

3 User Fee Amendments of 2017 for the cor4 responding fiscal year and the future plans 

5 of the Food and Drug Administration to 

6 meet these goals; and 

7 ‘‘(iii) the most common causes within 

8 the agency for missing such goals. 

9 ‘‘(B) Relevant data to determine whether 

10 the Center for Drug Evaluation and Research 

11 and the Center for Biologics Evaluation and Re12 search have met performance enhancement goals 

13 identified in the letters described in section 

14 101(b) of the Prescription Drug User Fee 

15 Amendments of 2017 for the corresponding fiscal 

16 year. 

17 ‘‘(C) External or other circumstances im18 pacting the Center for Drug Evaluation and Re19 search, the Center for Biologics Evaluation and 

20 Research, or the Food and Drug Administration, 

21 that impacted the ability of the agency to meet 

22 the review time and performance enhancement 

23 goals identified in the letters described in section 

24 101(b) of the Prescription Drug User Fee 

25 Amendments of 2017.’’. 


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1 (2) ISSUANCE OF CORRECTIVE ACTION RE2 PORTS.—Section 736B of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 379h–2) is amended— 

4 (A) by redesignating subsections (c) and (d) 

5 as subsections (e) and (f), respectively; and 

6 (B) inserting after subsection (b) the fol7 lowing: 

8 ‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 

9 fiscal year 2018, and for each fiscal year for which fees are 

10 collected under this part, the Secretary shall prepare and 

11 submit a corrective action report to the Committee on En12 ergy and Commerce and the Committee on Appropriations 

13 of the House of Representatives and the Committee on 

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

15 on Appropriations of the Senate upon submission of the 

16 performance report in subsection (a) for the corresponding 

17 fiscal year. The report shall include the following informa18 tion, as applicable: 

19 ‘‘(1) GOALS MET.—For each fiscal year, if the 

20 Secretary determines, based on the analysis under 

21 subsection (a)(5), that each of the goals identified in 

22 the letters described in section 101(b) of the Prescrip23 tion Drug User Fee Amendments of 2017 for the cor24 responding fiscal year have been met, the corrective 

25 action report shall include a summary of goals met, 


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1 and recommendations on ways in which the Secretary 

2 can improve and streamline the human drug applica3 tion review process. 

4 ‘‘(2) GOALS MISSED.—For each of the goals iden5 tified in the letters described in section 101(b) of the 

6 Prescription Drug User Fee Amendments of 2017 for 

7 the corresponding fiscal year that the Secretary deter8 mines to not have been met, the corrective action re9 port shall include a detailed justification for such de10 termination and— 

11 ‘‘(A) a detailed description of the cir12 cumstances under which each drug application 

13 that missed the review goal time was approved 

14 during the first cycle review, as applicable; 

15 ‘‘(B) aggregate data on the circumstances 

16 for all unapproved drug applications for which 

17 the review goal time was missed; and 

18 ‘‘(C) the performance enhancement goals 

19 that were not achieved during the previous fiscal 

20 year and a detailed description of efforts the 

21 agency has put in place for the current fiscal 

22 year to improve the ability of the agency to meet 

23 each such goal, while maintaining standards of 

24 approval, for the current fiscal year. 

25 ‘‘(d) ENHANCED COMMUNICATION.— 


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1 ‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each 

2 fiscal year, as applicable, representatives from the 

3 Center for Drug Evaluation and Research and the 

4 Center for Biologics Evaluation and Research shall 

5 meet with representatives from the Committee on 

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

7 and the Committee on Energy and Commerce of the 

8 House of Representatives to report on the contents de9 scribed in the reports under this section. 

10 ‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR11 ING.—Each fiscal year, as applicable, representatives 

12 from the Center for Drug Evaluation and Research 

13 and the Center for Biologics Evaluation and Research 

14 shall participate in a public hearing before the Com15 mittee on Health, Education, Labor, and Pensions of 

16 the Senate and the Committee on Energy and Com17 merce of the House of Representatives, to report on 

18 the contents described in the reports under this sec19 tion. Such hearing shall occur not later than 120 

20 days after the end of each fiscal year for which fees 

21 are collected under this part. 

22 ‘‘(3) PUBLICLY AVAILABLE UPDATES.—The Sec23 retary shall provide an update on progress made for 

24 the corrective action report during the following fiscal 

25 year on the publically available Internet website of 


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1 the Food and Drug Administration every 30 business 

2 days.’’. 

3 (b) MDUFA REPORTS.— 

4 (1) ANALYSIS IN MDUFA PERFORMANCE RE5 PORTS.—Section 738A(a)(1)(A) of the Federal Food, 

6 Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), 

7 as amended by section 802(b), is further amended by 

8 adding at the end the following: 

9 ‘‘(iv) ANALYSIS.—For each fiscal year, 

10 the Secretary shall include in the report 

11 under clause (i) an analysis of the fol12 lowing: 

13 ‘‘(I) The difference between the 

14 number of premarket applications filed 

15 under section 515 and applications 

16 filed under section 510(k) and the 

17 number of major deficiency letters, not 

18 approvable letters, and denials for such 

19 applications issued by the agency, ac20 counting for— 

21 ‘‘(aa) such applications filed 

22 during one fiscal year for which a 

23 decision is not scheduled to be 

24 made until the following fiscal 

25 year; 


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1 ‘‘(bb) such applications pend2 ing with the Center for Devices 

3 and Radiological Health that did 

4 not meet the goals as identified by 

5 the letters described in section 

6 201(b) of the Medical Device User 

7 Fee Amendments of 2017 for the 

8 corresponding fiscal year and the 

9 future plans of the Food and Drug 

10 Administration to meet these 

11 goals; and 

12 ‘‘(cc) the most common 

13 causes within the agency for miss14 ing such goals. 

15 ‘‘(II) Relevant data to determine 

16 whether the Center Devices and Radio17 logical Health have met performance 

18 enhancement goals identified by the let19 ters described in section 201(b) of the 

20 Medical Device User Fee Amendments 

21 of 2017 for the corresponding fiscal 

22 year. 

23 ‘‘(III) External or other cir24 cumstances impacting the Center De25 vices and Radiological Health or the 


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1 Food and Drug Administration that 

2 impacted the ability of the agency to 

3 meet review time and performance en4 hancement goals identified by the let5 ters described in section 201(b) of the 

6 Medical Device User Fee Amendments 

7 of 2017.’’. 

8 (2) ISSUANCE OF CORRECTIVE ACTION RE9 PORTS.—Section 738A(a) of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 379j–1(a)) is amend11 ed— 

12 (A) by redesignating paragraphs (2) and 

13 (3) as paragraphs (4) and (5), respectively; and 

14 (B) by inserting after paragraph (1) the fol15 lowing: 

16 ‘‘(2) CORRECTIVE ACTION REPORT.—Beginning 

17 with fiscal year 2018, and for each fiscal year for 

18 which fees are collected under this part, the Secretary 

19 shall prepare and submit a corrective action report to 

20 the Committee on Energy and Commerce and the 

21 Committee on Appropriations of the House of Rep22 resentatives and the Committee on Health, Education, 

23 Labor, and Pensions and the Committee on Appro24 priations of the Senate upon submission of the per25 formance report in paragraph (1)(A) for the corVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00230 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 responding fiscal year. The report shall include the 

2 following information, as applicable: 

3 ‘‘(A) GOALS MET.—For each fiscal year, if 

4 the Secretary determines, based on the analysis 

5 under paragraph (1)(A)(iv), that each of the 

6 goals identified by the letters described in section 

7 201(b) of the Medical Device User Fee Amend8 ments of 2017 for the corresponding fiscal year 

9 have been met, the corrective action report shall 

10 include a summary of goals met, and rec11 ommendations on ways in which the Secretary 

12 can improve and streamline the medical device 

13 application review process. 

14 ‘‘(B) GOALS MISSED.—For each of the goals 

15 identified by the letters described in section 

16 201(b) of the Medical Device User Fee Amend17 ments of 2017 for the corresponding fiscal year 

18 that the Secretary determines to not have been 

19 met, the corrective action report shall include a 

20 detailed justification for such determination 

21 and— 

22 ‘‘(i) a detailed description of the cir23 cumstances under which each application or 

24 report submitted under section 515 or sec25 tion 510(k) missed the review goal time but 


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1 was approved during the first cycle review, 

2 as applicable; 

3 ‘‘(ii) aggregate data on the cir4 cumstances for all unapproved medical de5 vice applications for which the review goal 

6 time was missed; and 

7 ‘‘(iii) the performance enhancement 

8 goals that were not achieved during the pre9 vious fiscal year and a detailed description 

10 of efforts the agency has put in place for the 

11 current fiscal year to improve the ability of 

12 the agency to meet each such goal, while 

13 maintaining standards of approval, for the 

14 current fiscal year. 

15 ‘‘(3) ENHANCED COMMUNICATION.— 

16 ‘‘(A) COMMUNICATIONS WITH CONGRESS.— 

17 Each fiscal year, as applicable, representatives 

18 from the Center for Devices and Radiological 

19 Health shall meet with representatives from the 

20 Committee on Health, Education, Labor, and 

21 Pensions of the Senate and the Committee on 

22 Energy and Commerce of the House of Rep23 resentatives to report on the contents described in 

24 the reports under this section. 


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1 ‘‘(B) PARTICIPATION IN CONGRESSIONAL

2 HEARING.—Each fiscal year, as applicable, rep3 resentatives from the Center for Devices and Ra4 diological Health shall participate in a public 

5 hearing before the Committee on Health, Edu6 cation, Labor, and Pensions of the Senate and 

7 the Committee on Energy and Commerce of the 

8 House of Representatives, to report on the con9 tents described in the reports under this section. 

10 Such hearing shall occur not later than 120 days 

11 after the end of each fiscal year for which fees 

12 are collected under this part. 

13 ‘‘(C) PUBLICLY AVAILABLE UPDATES.—The 

14 Secretary shall provide an update on progress 

15 made for the corrective action report during the 

16 following fiscal year on the publically available 

17 Internet website of the Food and Drug Adminis18 tration every 30 business days.’’. 

19 (c) GDUFA REPORTS.— 

20 (1) ANALYSIS IN GDUFA PERFORMANCE RE21 PORTS.—Section 744C(a) of the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 379j–43(a)), as amended 

23 by section 802(c) is further amended by adding at the 

24 end the following: 


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1 ‘‘(4) ANALYSIS.—For each fiscal year, the Sec2 retary shall include in the report an analysis of the 

3 following: 

4 ‘‘(A) The difference between the number of 

5 abbreviated new drug applications filed and the 

6 number of approvals or complete response letters 

7 issued by the agency, accounting for — 

8 ‘‘(i) such applications filed during one 

9 fiscal year for which a decision is not sched10 uled to be made until the following fiscal 

11 year; 

12 ‘‘(ii) such applications pending with 

13 the Office of Generic Drugs that did not 

14 meet the goals identified by the letters de15 scribed in section 301(b) of the Generic 

16 Drug User Fee Amendments of 2017 for the 

17 corresponding fiscal year and the future 

18 plans of the Food and Drug Administration 

19 to meet these goals; and 

20 ‘‘(iii) the most common causes within 

21 the agency for missing such goals. 

22 ‘‘(B) Relevant data to determine whether 

23 the Office of Generic Drugs has met the perform24 ance enhancement goals identified by the letters 

25 described in section 301(b) of the Generic Drug 


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1 User Fee Amendments of 2017 for the cor2 responding fiscal year. 

3 ‘‘(C) External or other circumstances im4 pacting the Office of Generic Drugs or the Food 

5 and Drug Administration that impacted the 

6 ability of the agency to meet review time and 

7 performance enhancement goals identified by the 

8 letters described in section 301(b) of the Generic 

9 Drug User Fee Amendments of 2017.’’. 

10 (2) ISSUANCE OF CORRECTIVE ACTION RE11 PORTS.—Section 744C of the Federal Food, Drug, 

12 and Cosmetic Act (21 U.S.C. 379j–43) is amended— 

13 (A) by redesignating subsections (c) and (d) 

14 as subsections (e) and (f), respectively; and 

15 (B) inserting after subsection (b) the fol16 lowing: 

17 ‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 

18 fiscal year 2018, and for each fiscal year for which fees are 

19 collected under this part, the Secretary shall prepare and 

20 submit a corrective action report to the Committee on En21 ergy and Commerce and the Committee on Appropriations 

22 of the House of Representatives and the Committee on 

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

24 on Appropriations of the Senate upon submission of the 

25 performance report in subsection (a) for the corresponding 


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1 fiscal year. The report shall include the following informa2 tion, as applicable: 

3 ‘‘(1) GOALS MET.—For each fiscal year, if the 

4 Secretary determines, based on the analysis under 

5 subsection (a)(4), that each of the goals identified by 

6 the letters described in section 301(b) of the Generic 

7 Drug User Fee Amendments of 2017 for the cor8 responding fiscal year have been met, the corrective 

9 action report shall include a summary of goals met, 

10 and recommendations on ways in which the Secretary 

11 can improve and streamline the abbreviated new drug 

12 application review process. 

13 ‘‘(2) GOALS MISSED.—For each of the goals iden14 tified by the letters described in section 301(b) of the 

15 Generic Drug User Fee Amendments of 2017 for the 

16 corresponding fiscal year that the Secretary deter17 mines to not have been met, the corrective action re18 port shall include a detailed justification for such de19 termination and— 

20 ‘‘(A) a detailed description of the cir21 cumstances under which each abbreviated new 

22 drug application missed the review goal time but 

23 was approved during the first cycle review, as 

24 applicable; 


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1 ‘‘(B) aggregate data on the circumstances 

2 for all unapproved abbreviated new drug appli3 cations for which the review goal time was 

4 missed; and 

5 ‘‘(C) the performance enhancement goals 

6 that were not achieved during the previous fiscal 

7 year and a detailed description of efforts the 

8 agency has put in place for the current fiscal 

9 year to improve the ability of the agency to meet 

10 each such goal for the current fiscal year. 

11 ‘‘(d) ENHANCED COMMUNICATION.— 

12 ‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each 

13 fiscal year, as applicable, representatives from the Of14 fice of Generic Drugs shall meet with representatives 

15 from the Committee on Health, Education, Labor, 

16 and Pensions of the Senate and the Committee on 

17 Energy and Commerce of the House of Representa18 tives to report on the contents described in the reports 

19 under this section. 

20 ‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR21 ING.—Each fiscal year, as applicable, representatives 

22 from the Center for Drug Evaluation and Research 

23 shall participate in a public hearing before the Com24 mittee on Health, Education, Labor, and Pensions of 

25 the Senate and the Committee on Energy and ComVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00237 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 merce of the House of Representatives, to report on 

2 the contents described in the reports under this sec3 tion. Such hearing shall occur not later than 120 

4 days after the end of each fiscal year for which fees 

5 are collected under this part. 

6 ‘‘(3) PUBLICLY AVAILABLE UPDATES.—The Sec7 retary shall provide an update on progress made for 

8 the corrective action report during the following fiscal 

9 year on the publically available Internet website of 

10 the Food and Drug Administration every 30 business 

11 days.’’. 

12 (d) BSUFA REPORTS.— 

13 (1) ANALYSIS IN BsUFA PERFORMANCE RE14 PORTS.—Section 744I(a) of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 379j–53(a)) as amended 

16 by section 802(d) is further amended by adding at the 

17 end the following: 

18 ‘‘(5) ANALYSIS.—For each fiscal year, the Sec19 retary shall include in the report an analysis of the 

20 following: 

21 ‘‘(A) The difference between the number of 

22 biosimilar biological product applications and 

23 supplements filed and the number of approvals 

24 or complete response letters issued by the agency, 

25 accounting for— 


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1 ‘‘(i) such applications filed during one 

2 fiscal year for which a decision is not sched3 uled to be made until the following fiscal 

4 year; 

5 ‘‘(ii) such applications pending with 

6 the Center for Drug Evaluation and Re7 search or the Center for Biologics Evalua8 tion and Research that did not meet the 

9 goals identified by the letters described in 

10 section 401(b) of the Biosimilar User Fee 

11 Amendments of 2017 for the corresponding 

12 fiscal year and the future plans of the Food 

13 and Drug Administration to meet these 

14 goals; and 

15 ‘‘(iii) the most common causes within 

16 the agency for missing such goals. 

17 ‘‘(B) Relevant data to determine whether 

18 the Center for Drug Evaluation and Research 

19 and the Center for Biologics Evaluation and Re20 search have met the performance enhancement 

21 goals identified by the letters described in section 

22 401(b) of the Biosimilar User Fee Amendments 

23 of 2017 for the corresponding fiscal year. 

24 ‘‘(C) External or other circumstances im25 pacting the Center for Drug Evaluation and ReVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00239 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 search, the Center for Biologics Evaluation and 

2 Research, and the Food and Drug Administra3 tion that impacted the ability of the agency to 

4 meet review time and performance enhancement 

5 goals identified by the letters described in section 

6 401(b) of the Biosimilar User Fee Amendments 

7 of 2017.’’. 

8 (2) ISSUANCE OF CORRECTIVE ACTION RE9 PORTS.—Section 744I of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 379j–53), as amended by sec11 tion 404, is further amended— 

12 (A) by redesignating subsections (c) and (d) 

13 as subsections (e) and (f), respectively; and 

14 (B) inserting after subsection (b) the fol15 lowing: 

16 ‘‘(c) CORRECTIVE ACTION REPORT.—Beginning with 

17 fiscal year 2018, and for each fiscal year for which fees are 

18 collected under this part, the Secretary shall prepare and 

19 submit a corrective action report to the Committee on En20 ergy and Commerce and Committee on Appropriations of 

21 the House of Representatives and the Committee on Health, 

22 Education, Labor, and Pensions and Committee on Appro23 priations of the Senate upon submission of the performance 

24 report in subsection (a) for the corresponding fiscal year. 


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1 The report shall include the following information, as ap2 plicable: 

3 ‘‘(1) GOALS MET.—For each fiscal year, if the 

4 Secretary determines, based on the analysis under 

5 subsection (a)(5), that each of the goals identified by 

6 the letters described in section 401(b) of the Bio7 similar User Fee Amendments of 2017 for the cor8 responding fiscal year have been met, the corrective 

9 action report shall include a summary of goals met, 

10 and recommendations on ways in which the Secretary 

11 can improve and streamline the biosimilar biological 

12 product application review process. 

13 ‘‘(2) GOALS MISSED.—For each of the goals iden14 tified by the letters described in section 401(b) of the 

15 Biosimilar User Fee Amendments of 2017 for the cor16 responding fiscal year that the Secretary determines 

17 to not have been met, the corrective action report shall 

18 include a detailed justification for such determination 

19 and— 

20 ‘‘(A) a detailed description of the cir21 cumstances under which each biosimilar biologi22 cal product application missed the review goal 

23 time but was approved during the first cycle re24 view, as applicable; 


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1 ‘‘(B) aggregate data on the circumstances 

2 for all biosimilar biological product applications 

3 for which the review goal time was missed; and 

4 ‘‘(C) the performance enhancement goals 

5 that were not achieved during the previous fiscal 

6 year and a detailed description of efforts the 

7 agency has put in place for the current fiscal 

8 year to improve the ability of the agency to meet 

9 each such goal for the current fiscal year. 

10 ‘‘(d) ENHANCED COMMUNICATION.— 

11 ‘‘(1) COMMUNICATIONS WITH CONGRESS.—Each 

12 fiscal year, as applicable, representatives from the 

13 Center for Drug Evaluation and Research and the 

14 Center for Biologics Evaluation and Research shall 

15 meet with representatives from the Committee on 

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

17 and the Committee on Energy and Commerce of the 

18 House of Representatives to report on the contents de19 scribed in the reports under this section. 

20 ‘‘(2) PARTICIPATION IN CONGRESSIONAL HEAR21 ING.—Each fiscal year, as applicable, representatives 

22 from the Center for Drug Evaluation and Research 

23 and the Center for Biologics Evaluation and Research 

24 shall participate in a public hearing before the Com25 mittee on Health, Education, Labor, and Pensions of 


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1 the Senate and the Committee on Energy and Com2 merce of the House of Representatives, to report on 

3 the contents described in the reports under this sec4 tion. Such hearing shall occur not later than 120 

5 days after the end of each fiscal year for which fees 

6 are collected under this part. 

7 ‘‘(3) PUBLICLY AVAILABLE UPDATES.—The Sec8 retary shall provide an update on progress made for 

9 the corrective action report during the following fiscal 

10 year on the publically available Internet website of 

11 the Food and Drug Administration every 30 business 

12 days.’’. 

13 SEC. 804. INFORMATION ON TECHNOLOGY CONTRACTING. 

14 Section 736B(b) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 379h–2(b)) is amended— 

16 (1) by striking ‘‘report on the’’ and inserting 

17 ‘‘report on— 

18 ‘‘(1) the’’; 

19 (2) by striking the period at the end and insert20 ing ‘‘; and’’; 

21 (3) by adding at the end the following: 

22 ‘‘(2) the amount of the fees collected that are in23 vested in the information technology infrastructure of 

24 the Food and Drug Administration, the entities re25 ceiving contracts to develop such infrastructure, the 


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1 length of such contracts (including renewals), and the 

2 progress such entities have made toward meeting the 

3 goals described in such contracts.’’. 

4 SEC. 805. FACILITIES MANAGEMENT. 

5 (a) EVALUATION.— 

6 (1) STUDY.—The Comptroller General of the 

7 United States shall conduct a study on the expenses 

8 incurred by the Food and Drug Administration re9 lated to facility maintenance and renovation in fiscal 

10 years 2012 through 2019. The study shall include the 

11 following: 

12 (A) A review of purchases and expenses dif13 ferentiated by appropriated funds, and resources 

14 authorized by the Food and Drug Administra15 tion Safety and Innovation Act (Public Law 

16 112–144) and this Act, as applicable, that con17 tributed to— 

18 (i) the maintenance of scientific equip19 ment and any existing facility plan or 

20 plans to maintain previously purchased sci21 entific equipment; 

22 (ii) the renovation of facilities in the 

23 Center for Drug Evaluation and Research, 

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1 diological Health, and the purpose of such 

2 renovation including the need for the ren3 ovation; 

4 (iii) the assets purchased or repaired 

5 under the ‘‘repair of facilities and acquisi6 tion’’ authority under parts 2, 3, 7, and 8 

7 of subchapter C of chapter VII of the Fed8 eral Food, Drug, and Cosmetic Act (21 

9 U.S.C. 379f et seq.); 

10 (iv) the maintenance and repair of fa11 cilities and fixtures, including a description 

12 of any unanticipated repairs and mainte13 nance as well as scheduled repairs mainte14 nance, and the budget plan for the scheduled 

15 or anticipated maintenance; 

16 (v) the acquisition of furniture, a de17 scription of the furniture purchased, and 

18 the purpose of the furniture including pur19 chases for the Center for Drug Evaluation 

20 and Research, the Center for Biologics Eval21 uation and Research, and the Center for 

22 Devices and Radiological Health; and 

23 (vi) the acquisition of other necessary 

24 materials and supplies by product category 

25 under the authority under parts 2, 3, 7, 


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1 and 8 of subchapter C of chapter VII of the 

2 Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 379f et seq.). 

4 (B) An analysis of the Food and Drug Ad5 ministration’s ability to further its public health 

6 mission and review medical products by incur7 ring the expenses listed in clauses (i) through 

8 (vi) of subparagraph (A). In conducting the 

9 analysis, the Comptroller General shall request 

10 information from and consult with appropriate 

11 employees, including staff and those responsible 

12 for the fiscal decisions regarding facility mainte13 nance and renovation for the agency. 

14 (C) RECOMMENDATIONS.—The Comptroller 

15 General may provide recommendations, as appli16 cable, on methods through which the Food and 

17 Drug Administration may improve planning 

18 for— 

19 (i) the maintenance, renovation, and 

20 repair of facilities; 

21 (ii) the purchase of furniture or other 

22 acquisitions; and 

23 (iii) ways the agency may allocate the 

24 expenses described in clauses (i) and (ii), as 


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1 informed by the analysis under subpara2 graph (B). 

3 (2) REPORT.—The Comptroller General shall 

4 issue a report to the Committee on Health, Edu5 cation, Labor, and Pensions of the Senate and the 

6 Committee on Energy and Commerce of the House of 

7 Representatives not later than September 30, 2020, 

8 containing the results of the study under paragraph 

9 (1). 

10 (b) ADMINISTRATION.— 

11 (1) PDUFA.—Section 736(f) of the Federal 

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

13 amended by adding at the end the following: 

14 ‘‘(3) LIMITATION.—Beginning on October 1, 

15 2023, the authorities under section 735(7)(C) shall 

16 only include expenditures for leasing and necessary 

17 scientific equipment.’’. 

18 (2) MDUFA.—Section 738(h) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is 

20 amended by adding at the end the following: 

21 ‘‘(3) LIMITATION.—Beginning on October 1, 

22 2023, the authorities under section 737(9)(C) shall 

23 only include leasing and necessary scientific equip24 ment.’’. 


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1 (3) GDUFA.—Section 744B(e) of the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(e)) 

3 is amended— 

4 (A) in the subsection heading, by striking 

5 ‘‘LIMIT’’ and inserting ‘‘LIMITATIONS’’; 

6 (B) by striking ‘‘The total amount’’ and in7 serting the following: 

8 ‘‘(1) IN GENERAL.—The total amount’’; and 

9 (C) by adding at the end the following: 

10 ‘‘(2) LEASING AND NECESSARY EQUIPMENT.—Be11 ginning on October 1, 2023, the authorities under sec12 tion 744A(11)(C) shall only include leasing and nec13 essary scientific equipment.’’. 

14 (4) BSUFA.—Section 744H(e)(2)(B) of the Fed15 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

16 52(e)(2)(B)) is amended— 

17 (A) in the subparagraph heading, by strik18 ing ‘‘LIMITATION’’ and inserting ‘‘LIMITATIONS’’; 

19 (B) by striking ‘‘The fees authorized’’ and 

20 inserting the following: 

21 ‘‘(i) IN GENERAL.—The fees author22 ized’’; and 

23 (C) by adding at the end the following: 

24 ‘‘(ii) LEASING AND NECESSARY EQUIP25 MENT.—Beginning on October 1, 2023, the 


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1 authorities under section 744G(9)(C) shall 

2 only include leasing and necessary scientific 

3 equipment.’’. 

4 SEC. 806. EXPANDED ACCESS. 

5 (a) PATIENT ACCESS TO EXPERIMENTAL TREAT6 MENTS.— 

7 (1) PUBLIC MEETING.— 

8 (A) IN GENERAL.—The Secretary of Health 

9 and Human Services (referred to in this section 

10 as the ‘‘Secretary’’), acting through the Commis11 sioner of Food and Drugs, in coordination with 

12 the Director of the National Institutes of Health, 

13 and in consultation with patients, health care 

14 providers, drug sponsors, bioethicists, and other 

15 stakeholders, shall, not later than 180 days after 

16 the date of enactment of this Act, convene a pub17 lic meeting to discuss clinical trial inclusion and 

18 exclusion criteria to inform the guidance under 

19 paragraph (3). The Secretary shall inform the 

20 Comptroller General of the United States of the 

21 date when the public meeting will take place. 

22 (B) TOPICS.—The Secretary shall provide a 

23 publicly available report on the topics discussed 

24 at the meeting described in subparagraph (A) 


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1 within 30 days of such meeting. Such topics 

2 shall include discussion of— 

3 (i) the rationale for, and potential bar4 riers for patients created by, clinical trial 

5 inclusion and exclusion criteria; 

6 (ii) how patient populations most like7 ly to be affected by a drug can benefit from 

8 the results of trials that employ alternative 

9 designs, as well as potential risks associated 

10 with alternative clinical trial designs; 

11 (iii) barriers to participation in clin12 ical trials, including— 

13 (I) information regarding any po14 tential risks and benefits of participa15 tion; 

16 (II) regulatory, geographical, and 

17 socioeconomic barriers; and 

18 (III) the impact of exclusion cri19 teria on the enrollment in clinical 

20 trials of infants and children, pregnant 

21 and lactating women, seniors, individ22 uals with advanced disease, and indi23 viduals with co-morbid conditions; 

24 (iv) clinical trial designs and methods 

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1 tient populations while facilitating the col2 lection of data to support substantial evi3 dence of safety and effectiveness; and 

4 (v) how changes to clinical trial inclu5 sion and exclusion criteria may impact the 

6 complexity of the clinical trial design and 

7 length of clinical trials, and potential ap8 proaches to mitigating those impacts to en9 sure that the ability to demonstrate safety 

10 and effectiveness is not hindered through po11 tential changes in eligibility criteria. 

12 (2) REPORT.—Not later than 1 year after the 

13 Secretary issues a report on the topics discussed at 

14 the public meeting under paragraph (1)(B), the 

15 Comptroller General of the United States shall report 

16 to the Committee on Health, Education, Labor, and 

17 Pensions of the Senate and the Committee on Energy 

18 and Commerce of the House of Representatives on in19 dividual access to investigational drugs through the 

20 expanded access program under section 561(b) of the 

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

22 360bbb(b)). The report shall include— 

23 (A) a description of actions taken by manu24 facturers under section 561A of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 360bbb–0); 


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1 (B) consideration of whether Form FDA 

2 3926 and the guidance document entitled ‘‘Ex3 panded Access to Investigational Drugs for 

4 Treatment Use—Questions and Answers’’, issued 

5 by the Food and Drug Administration in June 

6 2016, has reduced application burden with re7 spect to individuals and physicians seeking ac8 cess to investigational new drugs pursuant to 

9 section 561(b) of the Federal Food, Drug, and 

10 Cosmetic Act (21 U.S.C. 360bbb) and improved 

11 clarity for patients, physicians, and drug manu12 facturers about such process; 

13 (C) consideration of whether the guidance or 

14 regulations released or updated under section 

15 561 of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 360bbb) have improved access for in17 dividual patients who do not qualify for clinical 

18 trials of such investigational drugs, and what 

19 barriers to such access remain; 

20 (D) an assessment of how patients and 

21 health care providers navigate different avenues 

22 to engage with the Food and Drug Administra23 tion or drug sponsors on expanded access; and 

24 (E) an analysis of the Secretary’s report 

25 under paragraph (1)(B). 


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1 (3) GUIDANCE.— 

2 (A) IN GENERAL.—Not later than 180 days 

3 after the publication of the report under para4 graph (1), the Secretary, acting through the 

5 Commissioner of Food and Drugs, shall issue one 

6 or more draft guidances regarding eligibility cri7 teria for clinical trials. Not later than 18 months 

8 after the public comment period on each such 

9 draft guidance ends, the Secretary shall issue a 

10 revised draft guidance or final guidance. 

11 (B) CONTENTS.—The guidance documents 

12 described in subparagraph (A) shall address 

13 methodological approaches that a manufacturer 

14 or sponsor of an investigation of a new drug 

15 may take to— 

16 (i) broaden eligibility criteria for clin17 ical trials, especially with respect to drugs 

18 for the treatment of serious and life-threat19 ening conditions or diseases for which there 

20 is an unmet medical need; and 

21 (ii) develop eligibility criteria for, and 

22 increase trial recruitment to, clinical trials 

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1 priate, while supporting findings of sub2 stantial evidence of safety and effectiveness. 

3 (b) IMPROVING INSTITUTIONAL REVIEW BOARD RE4 VIEW OF SINGLE PATIENT EXPANDED ACCESS PRO5 TOCOL.—Not later than 1 year after the date of enactment 

6 of this Act, the Secretary, acting through the Commissioner 

7 of Food and Drugs, shall issue guidance or regulations, or 

8 revise existing guidance or regulations, to streamline the 

9 institutional review board review for individual pediatric 

10 and adult patient expanded access protocol under 561(b) 

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

12 360bbb(b)). Such guidance or regulation may include a de13 scription of the conditions under which an institutional re14 view board chair (or designee) may review individual pa15 tient expanded access protocol submitted under section 

16 505(i) of the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 355(i)) for a drug and how centralized institutional 

18 review boards may facilitate the use of expanded access pro19 tocols. The Secretary shall update any relevant forms asso20 ciated with individual patient expanded access protocol as 

21 necessary. 

22 (c) EXPANDED ACCESS POLICY TRANSPARENCY.—Sec23 tion 561A(f) of the Federal Food, Drug, and Cosmetic Act 

24 (21 U.S.C. 360bbb–0(f)) is amended— 


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1 (1) in the matter preceding paragraph (1), by 

2 striking ‘‘later’’ and inserting ‘‘earlier’’; 

3 (2) by striking paragraph (1); 

4 (3) by redesignating paragraph (2) as para5 graph (1); 

6 (4) in paragraph (1) as so redesignated, by strik7 ing the period at the end and inserting ‘‘; or’’; and 

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

9 ‘‘(2) as applicable, 15 days after the drug re10 ceives a designation as a breakthrough therapy, fast 

11 track product, or regenerative advanced therapy 

12 under subsection (a), (b), or (g), respectively, of sec13 tion 506.’’. 

14 SEC. 807. TECHNICAL CORRECTIONS. 

15 (a) CROSS-REFERENCE.—Section 3075(a) of the 21st 

16 Century Cures Act (Public Law 114–255) is amended— 

17 (1) in the matter preceding paragraph (1), by 

18 striking ‘‘as amended by section 2074’’ and inserting 

19 ‘‘as amended by section 3102’’; and 

20 (2) in paragraph (2), by striking ‘‘section 

21 2074(1)(C)’’ and inserting ‘‘section 3102(1)(C)’’. 

22 (b) 506G.—Section 506G(b)(1)(A) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is 

24 amended by striking ‘‘identity’’ and inserting ‘‘identify’’. 


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1 TITLE IX—GENERIC DRUG 

2 ACCESS 

3 Subtitle A—Removing Regulatory 

4 Barriers to Competition 

5 SEC. 901. IMPROVING ACCESS TO GENERIC DRUGS. 

6 Section 505(j) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 355(j)) is amended by adding at the 

8 end the following: 

9 ‘‘(11)(A) The Secretary shall prioritize the review of, 

10 and act within 240 calendar days of the date of the submis11 sion of, an original abbreviated new drug application sub12 mitted for review under this subsection, or on a supplement 

13 to such an application, that is for a drug— 

14 ‘‘(i) for which there are not more than 3 ap15 proved drugs listed under paragraph (7), except that 

16 the review of an application submitted more than 30 

17 months in advance of the last applicable expiration 

18 date for a patent for which a certification under 

19 paragraph (2)(A)(vii)(III) has been submitted, or of 

20 the expiration date for an applicable period of exclu21 sivity under this Act, will not be expedited; or 

22 ‘‘(ii) that has been included on the list under sec23 tion 506E. 

24 ‘‘(B) The Secretary shall require the applicant, not 

25 later than 60 days prior to the submission of an application 


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1 described in subparagraph (A), to provide complete, accu2 rate information regarding facilities involved in manufac3 turing processes and testing, including facilities in cor4 responding Type II active pharmaceutical ingredients drug 

5 master files submitted with an application and sites or or6 ganizations involved in bioequivalence and clinical studies 

7 used to support the application, in order to make a deter8 mination regarding whether an inspection of an establish9 ment is necessary. 

10 ‘‘(C) The Secretary may expedite an inspection or re11 inspection under section 704 of an establishment that pro12 poses to manufacture a drug described in subparagraph (A). 

13 ‘‘(D) Nothing in this paragraph shall prevent the Sec14 retary from prioritizing the review of other applications as 

15 the Secretary determines appropriate. 

16 ‘‘(12) The Secretary shall provide review status up17 dates to applicants regarding applications under this sub18 section, as appropriate, including when the application is 

19 awaiting final regulatory action by the office charged with 

20 review. 

21 ‘‘(13) The Secretary shall publish on the Internet 

22 website of the Food and Drug Administration a list of all 

23 drugs approved under subsection (b) for which all patents 

24 and periods of exclusivity under this Act have expired. Such 

25 list shall be updated at least once every 180 days.’’. 


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1 SEC. 902. REPORTING ON PENDING GENERIC DRUG APPLI2 CATIONS, PRIORITY REVIEW APPLICATIONS, 

3 AND INSPECTIONS. 

4 (a) IN GENERAL.—Not later than 180 calendar days 

5 after the date of enactment of this Act, and quarterly there6 after until October 1, 2022, the Secretary of Health and 

7 Human Services (referred to in this section as the ‘‘Sec8 retary’’) shall post on the Internet website of the Food and 

9 Drug Administration a report that provides— 

10 (1) the number of applications filed under sec11 tion 505(j) of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 355(j)) awaiting action by the appli13 cant, including such applications that were filed 

14 prior to October 1, 2014; 

15 (2) the number of applications filed under sec16 tion 505(j) of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 355(j)) awaiting action by the Sec18 retary, including such applications that were filed 

19 prior to October 1, 2014; 

20 (3) the number of applications filed under sec21 tion 505(j) of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 355(j)) and prior approval supple23 ments withdrawn in each month covered by the re24 port; 

25 (4) the mean and median approval and tentative 

26 approval times for applications covered by the report; 


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1 (5) the number of applications described in 

2 paragraphs (1), (2), and (3) that are subject to pri3 ority review; and 

4 (6) the number of such applications on which the 

5 Secretary has taken action pursuant to section 

6 506H(b) of the Federal Food, Drug, and Cosmetic 

7 Act, as added by section 911. 

8 (b) ANNUAL REPORT ON PRIORITY REVIEW APPLICA9 TIONS.— 

10 (1) IN GENERAL.—The Secretary shall submit to 

11 the Committee on Health, Education, Labor, and 

12 Pensions and the Special Committee on Aging of the 

13 Senate and the Committee on Energy and Commerce 

14 of the House of Representatives an annual report, not 

15 later than March 31 of each year, on the following: 

16 (A) The number of applications filed under 

17 section 505(j) of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 355(j)) that are subject 

19 to priority review during the most recent cal20 endar year and are awaiting action by the ap21 plicant. 

22 (B) The number of applications filed under 

23 section 505(j) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 355(j)) that are subject 

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1 endar year and are awaiting action by the Sec2 retary. 

3 (C) The number of applications filed under 

4 section 505(j) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 355(j)) that are subject 

6 to priority review during the most recent cal7 endar year and have been approved by the Sec8 retary. 

9 (D) For each of subparagraphs (A) through 

10 (C), the number of such applications— 

11 (i) for which there are not more than 

12 3 approved drugs listed under section 

13 505(j)(7) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 355(j)(7)); and 

15 (ii) the number of such applications 

16 that are for a drug on the drug shortage list 

17 under section 506E of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 356e). 

19 (c) ANNUAL REPORT ON INSPECTIONS.—Not later than 

20 March 1 of each year, the Secretary shall post on the Inter21 net website of the Food and Drug Administration— 

22 (1) the average and median amount of time, fol23 lowing a request by staff of the Food and Drug Ad24 ministration reviewing an application or report sub25 mitted under an applicable section described in subVerDate Sep 11 2014 20:43 May 11, 2017 Jkt 069200 PO 00000 Frm 00260 Fmt 6652 Sfmt 6203 E:\BILLS\S934.RS S934

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1 paragraph (A), (B), or (C), to schedule and complete 

2 inspections of facilities necessary for— 

3 (A) approval of a drug under section 505 of 

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

5 U.S.C. 355); 

6 (B) approval of a device under section 515 

7 of such Act (21 U.S.C. 360e); and 

8 (C) clearance of a device under section 

9 510(k) of such Act (21 U.S.C. 360(k)); and 

10 (2) the average and median amount of time to 

11 schedule and complete for-cause inspections of facili12 ties of drugs and devices. 

13 Subtitle B—Incentivizing 

14 Competition 

15 SEC. 911. EXPEDITING GENERIC COMPETITION. 

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

17 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

18 section 506G the following: 

19 ‘‘SEC. 506H. EXPEDITING GENERIC DRUG DEVELOPMENT. 

20 ‘‘(a) IN GENERAL.—The Secretary shall, at the request 

21 of an applicant, expedite the development and review of an 

22 application under subsection (j) of section 505 for a drug— 

23 ‘‘(1) for which there are not more than 3 ap24 proved drug products listed under section 505(j)(7); 

25 or 


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1 ‘‘(2) that is included on the list under section 

2 506E. 

3 ‘‘(b) REQUEST FROM SPONSORS.—A request to expe4 dite the development and review of an application under 

5 subsection (a) shall be submitted by the applicant prior to 

6 the submission of such application. 

7 ‘‘(c) OTHER APPLICATIONS.—Nothing in this section 

8 shall prevent the Secretary from expediting the development 

9 and review of other applications as the Secretary deter10 mines appropriate. 

11 ‘‘(d) ADDITIONAL COMMUNICATION.—The Secretary 

12 shall take such actions as are appropriate to expedite the 

13 development and review of the application for approval of 

14 a drug described in subsection (a), including, as appro15 priate— 

16 ‘‘(1) holding meetings with the sponsor and the 

17 review team throughout the development of the drug 

18 prior to submission of the application; 

19 ‘‘(2) providing timely advice to, and interactive 

20 communication with, the sponsor regarding the devel21 opment of the application to ensure that the collection 

22 of nonclinical and clinical data necessary for ap23 proval is as efficient as practicable; 

24 ‘‘(3) in the case of a complex product, assigning 

25 a cross-disciplinary project lead for the review team 


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1 to facilitate an efficient review of the development 

2 program and application, including manufacturing 

3 inspections; and 

4 ‘‘(4) in the case of a complex product, including 

5 drug-device combinations, involving senior managers 

6 and experienced review staff, as appropriate, in a col7 laborative, cross- disciplinary review. 

8 ‘‘(e) REPORTING REQUIREMENT.—A sponsor of a drug 

9 expedited under this section shall report to the Secretary, 

10 one year following approval of an application under section 

11 505(j), on whether the approved drug has been marketed 

12 in interstate commerce since approval.’’. 

13 SEC. 912. LIST OF GENERIC DRUGS WITH LIMITED COM14 PETITION. 

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

16 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

17 section 506H, as added by section 911, the following: 

18 ‘‘SEC. 506I. DRUG LISTING. 

19 ‘‘(a) REMOVAL, WITHDRAWAL, OR TRANSFER.—The 

20 holder of an application approved under subsection (b) or 

21 (j) of section 505 shall notify the Secretary within 180 days 

22 of removing the drug that is the subject of such application 

23 from interstate commerce, withdrawing such approved ap24 plication, or transferring such approved application, and 

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1 pliance with this subsection within such 180-day period is 

2 not practicable, then the holder shall comply as soon as 

3 practicable. The Secretary shall cross-reference information 

4 listed pursuant to section 506C where applicable to avoid 

5 duplicative reporting. 

6 ‘‘(b) DRUGS WITH LIMITED COMPETITION.— 

7 ‘‘(1) INFORMATION.—The Secretary shall— 

8 ‘‘(A) maintain information with respect to 

9 applications approved under section 505(j); and 

10 ‘‘(B) publish on the Internet website of the 

11 Food and Drug Administration such informa12 tion under subparagraph (A) with respect to 

13 drugs for which there are 3 or fewer application 

14 holders; and 

15 ‘‘(C) update the information published pur16 suant to subparagraph (B) every 180 days. 

17 ‘‘(2) CONTENTS.—The public information main18 tained and published under paragraph (1)(B) shall 

19 include— 

20 ‘‘(A) the name of the drug, name of the 

21 holder of the approved application, and the mar22 keting status for each drug; and 

23 ‘‘(B) an indication of whether the Secretary 

24 considers the drug to be for the treatment or pre25 vention of a serious disease or medical condition, 


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1 for which there is no alternative drug that is 

2 judged by medical professionals to be an ade3 quate substitute available in adequate supply. 

4 ‘‘(c) PUBLIC HEALTH EXCEPTION.—The Secretary 

5 may choose not to make information collected under this 

6 section publicly available if the Secretary determines that 

7 disclosure of such information would adversely affect the 

8 public health. 

9 ‘‘(d) NOTIFICATION.—When the Secretary first pub10 lishes the information under subsection (b), the Secretary 

11 shall notify relevant Federal agencies, including the Centers 

12 for Medicare & Medicaid Services and the Federal Trade 

13 Commission, that the information has been published and 

14 will be updated regularly.’’. 

15 SEC. 913. SUITABILITY PETITIONS. 

16 (a) IN GENERAL.—It is the sense of the Senate that 

17 the Food and Drug Administration shall meet the require18 ment under section 505(j)(2)(C) of the Federal Food, Drug, 

19 and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and section 

20 314.93(e) of title 21, Code of Federal Regulations, of re21 sponding to suitability petitions within 90 days of submis22 sion. 

23 (b) REPORT.—The Secretary of Health and Human 

24 Services shall include in the annual reports under section 

25 902(b)— 


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1 (1) the number of pending petitions under sec2 tion 505(j)(2)(C) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 355(j)(2)(C)); and 

4 (2) the number of such petitions pending a sub5 stantive response for more than 180 days from the 

6 date of receipt. 

7 SEC. 914. INSPECTIONS. 

8 Section 505(j) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355(j)), as amended by section 901, 

10 is further amended by adding at the end the following: 

11 ‘‘(14) If the Secretary issues feedback pursuant to sec12 tion 704(b)(2) with respect to information submitted in re13 sponse to a report under section 704(b)(1), and a report 

14 that was issued under section 704(b)(1) is the only obstacle 

15 to approval of an application under this subsection or the 

16 Secretary determines that the public health benefit of ap17 proving an application under this subsection outweighs any 

18 risk to public health, the Secretary shall, within 45 days 

19 of notification by the applicant that necessary changes have 

20 been made to the establishment to address any findings or 

21 deficiencies identified previously by the Secretary— 

22 ‘‘(A) re-inspect the establishment with respect to 

23 which the report was issued; or 


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1 ‘‘(B) make a determination regarding the re2 sponse to such report and review of such applica3 tion.’’. 


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Calendar No. 76 

115TH CONGRESS 

1ST SESSION S. 934 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

other purposes. drugs, and biosimilar biological products, and for for prescription drugs, medical devices, generic Act to revise and extend the user-fee programs 

MAY 11, 2017 

Reported with an amendment 


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