II 

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 

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, 

3 SECTION 1. SHORT TITLE. 

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

5 Act of 2017’’. 

6 SEC. 2. TABLE OF CONTENTS. 

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

Sec. 1. Short title. 


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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 

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. 


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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.— 

21 (1) IN GENERAL.—Section 736(a) of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

23 379h(a)) is amended— 


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

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

3 ‘‘fiscal year 2018’’; 

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

5 striking ‘‘AND SUPPLEMENT’’; 

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

7 supplement’’ and ‘‘or supplement’’ each place 

8 either appears; 

9 (D) in paragraph (1)(A)— 

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

11 and inserting ‘‘(c)(5)’’; and 

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

13 established’’ and all that follows through 

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

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

16 for a human drug application for which 

17 clinical data (other than bioavailability or 

18 bioequivalence studies) with respect to 

19 safety or effectiveness are not required for 

20 approval.’’; 

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

22 striking ‘‘OR SUPPLEMENT’’; 

23 (F) in paragraph (1)(F)— 

24 (i) in the heading, by striking ‘‘OR IN25 DICATION’’; and 


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1 (ii) by striking the second sentence; 

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

3 a prescription drug establishment fee); 

4 (H) by redesignating paragraph (3) as 

5 paragraph (2); 

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

7 redesignated, by striking ‘‘PRESCRIPTION DRUG

8 PRODUCT FEE’’ and inserting ‘‘PRESCRIPTION

9 DRUG PROGRAM FEE’’; 

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

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

12 follows: ‘‘Except as provided in subparagraphs 

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

14 applicant in a human drug application, and 

15 who, after September 1, 1992, had pending be16 fore the Secretary a human drug application or 

17 supplement, shall pay the annual prescription 

18 drug program fee established for a fiscal year 

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

20 drug product that is identified in such a human 

21 drug application approved as of October 1 of 

22 such fiscal year.’’; 

23 (K) in subparagraph (B) of such para24 graph (2)— 


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1 (i) in the heading of subparagraph 

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

3 following: ‘‘FOR CERTAIN PRESCRIPTION

4 DRUG PRODUCTS’’; and 

5 (ii) by striking ‘‘A prescription drug 

6 product shall not be assessed a fee’’ and 

7 inserting ‘‘A prescription drug program fee 

8 shall not be assessed for a prescription 

9 drug product’’; and 

10 (L) by adding at the end of such para11 graph (2) the following: 

12 ‘‘(C) LIMITATION.—A person who is 

13 named as the applicant in an approved human 

14 drug application shall not be assessed more 

15 than 5 prescription drug program fees for a fis16 cal year for prescription drug products identi17 fied in such approved human drug applica18 tion.’’. 

19 (2) CONFORMING AMENDMENT.—Subparagraph 

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

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

22 amended to read as follows: 

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

24 be assessed only one fee per fiscal year under 

25 this section.’’. 


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1 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec2 tion 736 of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 379h) is amended to read as follows: 

4 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

6 2018 through 2022, fees under subsection (a) shall, 

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

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

9 amount under such subsection that is equal to the 

10 sum of— 

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

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

13 ‘‘(B) the dollar amount equal to the infla14 tion adjustment for the fiscal year (as deter15 mined under subsection (c)(1)); 

16 ‘‘(C) the dollar amount equal to the capac17 ity planning adjustment for the fiscal year (as 

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

19 ‘‘(D) the dollar amount equal to the oper20 ating reserve adjustment for the fiscal year, if 

21 applicable (as determined under subsection 

22 (c)(3)); 

23 ‘‘(E) the dollar amount equal to the addi24 tional direct cost adjustment for the fiscal year 

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


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1 ‘‘(F) additional dollar amounts for each 

2 fiscal year as follows: 

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

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

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

6 2020; 

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

8 and 

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

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

11 amount determined for a fiscal year under para12 graph (1)— 

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

14 human drug application fees under subsection 

15 (a)(1); and 

16 ‘‘(B) 80 percent shall be derived from pre17 scription drug program fees under subsection 

18 (a)(2). 

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

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

21 base revenue for a fiscal year shall be— 

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

23 and 

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

25 the dollar amount of the total revenue amount 


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1 established under paragraph (1) for the pre2 vious fiscal year, not including any adjustments 

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

4 (c) ADJUSTMENTS; ANNUAL FEE SETTING.—Sub5 section (c) of section 736 of the Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 379h) is amended to read as fol7 lows: 

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

9 ‘‘(1) INFLATION ADJUSTMENT.— 

10 ‘‘(A) IN GENERAL.—For purposes of sub11 section (b)(1)(B), the dollar amount of the in12 flation adjustment to the annual base revenue 

13 for each fiscal year shall be equal to the prod14 uct of— 

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

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

17 ‘‘(ii) the inflation adjustment percent18 age under subparagraph (B). 

19 ‘‘(B) INFLATION ADJUSTMENT PERCENT20 AGE.—The inflation adjustment percentage 

21 under this subparagraph for a fiscal year is 

22 equal to the sum of— 

23 ‘‘(i) the average annual percent 

24 change in the cost, per full-time equivalent 

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1 tion, of all personnel compensation and 

2 benefits paid with respect to such positions 

3 for the first 3 years of the preceding 4 fis4 cal years, multiplied by the proportion of 

5 personnel compensation and benefits costs 

6 to total costs of the process for the review 

7 of human drug applications (as defined in 

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

9 preceding 4 fiscal years; and 

10 ‘‘(ii) the average annual percent 

11 change that occurred in the Consumer 

12 Price Index for urban consumers (Wash13 ington-Baltimore, DC–MD–VA–WV; Not 

14 Seasonally Adjusted; All items; Annual 

15 Index) for the first 3 years of the pre16 ceding 4 years of available data multiplied 

17 by the proportion of all costs other than 

18 personnel compensation and benefits costs 

19 to total costs of the process for the review 

20 of human drug applications (as defined in 

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

22 preceding 4 fiscal years. 

23 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

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

25 after the annual base revenue established in 


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

2 accordance with paragraph (1), such revenue 

3 shall be adjusted further for such fiscal year, in 

4 accordance with this paragraph, to reflect 

5 changes in the resource capacity needs of the 

6 Secretary for the process for the review of 

7 human drug applications. 

8 ‘‘(B) INTERIM METHODOLOGY.— 

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

10 planning methodology described in sub11 paragraph (C) is effective, the adjustment 

12 under this paragraph for a fiscal year shall 

13 be based on the product of— 

14 ‘‘(I) the annual base revenue for 

15 such year, as adjusted for inflation 

16 under paragraph (1); and 

17 ‘‘(II) the adjustment percentage 

18 under clause (ii). 

19 ‘‘(ii) ADJUSTMENT PERCENTAGE.— 

20 The adjustment percentage under this 

21 clause for a fiscal year is the weighted 

22 change in the 3-year average ending in the 

23 most recent year for which data are avail24 able, over the 3-year average ending in the 

25 previous year, for— 


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1 ‘‘(I) the total number of human 

2 drug applications, efficacy supple3 ments, and manufacturing supple4 ments submitted to the Secretary; 

5 ‘‘(II) the total number of active 

6 commercial investigational new drug 

7 applications; and 

8 ‘‘(III) the total number of formal 

9 meetings scheduled by the Secretary, 

10 and written responses issued by the 

11 Secretary in lieu of such formal meet12 ings, as identified in section I.H of 

13 the letters described in section 101(b) 

14 of the Prescription Drug User Fee 

15 Amendments of 2017. 

16 ‘‘(C) CAPACITY PLANNING METHOD17 OLOGY.— 

18 ‘‘(i) DEVELOPMENT; EVALUATION

19 AND REPORT.—The Secretary shall obtain, 

20 through a contract with an independent ac21 counting or consulting firm, a report evalu22 ating options and recommendations for a 

23 new methodology to accurately assess 

24 changes in the resource and capacity needs 

25 of the process for the review of human 


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1 drug applications. The capacity planning 

2 methodological options and recommenda3 tions presented in such report shall utilize 

4 and be informed by personnel time report5 ing data as an input. The report shall be 

6 published for public comment no later than 

7 the end of fiscal year 2020. 

8 ‘‘(ii) ESTABLISHMENT AND IMPLE9 MENTATION.—After review of the report 

10 described in clause (i) and any public com11 ments thereon, the Secretary shall estab12 lish a capacity planning methodology for 

13 purposes of this paragraph, which shall— 

14 ‘‘(I) replace the interim method15 ology under subparagraph (B); 

16 ‘‘(II) incorporate such ap17 proaches and attributes as the Sec18 retary determines appropriate; and 

19 ‘‘(III) be effective beginning with 

20 the first fiscal year for which fees are 

21 set after such capacity planning meth22 odology is established. 

23 ‘‘(D) LIMITATION.—Under no cir24 cumstances shall an adjustment under this 

25 paragraph result in fee revenue for a fiscal year 


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1 that is less than the sum of the amounts under 

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

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

4 amount of the inflation adjustment for the fis5 cal year). 

6 ‘‘(E) PUBLICATION IN FEDERAL REG7 ISTER.—The Secretary shall publish in the Fed8 eral Register notice under paragraph (5) the fee 

9 revenue and fees resulting from the adjustment 

10 and the methodologies under this paragraph. 

11 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

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

13 subsequent fiscal years, the Secretary may, in 

14 addition to adjustments under paragraphs (1) 

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

16 fees if such an adjustment is necessary to pro17 vide for not more than 14 weeks of operating 

18 reserves of carryover user fees for the process 

19 for the review of human drug applications. 

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

21 carryover balances for such process in excess of 

22 14 weeks of such operating reserves, the Sec23 retary shall decrease such fee revenue and fees 

24 to provide for not more than 14 weeks of such 

25 operating reserves. 


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1 ‘‘(C) NOTICE OF RATIONALE.—If an ad2 justment under subparagraph (A) or (B) is 

3 made, the rationale for the amount of the in4 crease or decrease (as applicable) in fee revenue 

5 and fees shall be contained in the annual Fed6 eral Register notice under paragraph (5) estab7 lishing fee revenue and fees for the fiscal year 

8 involved. 

9 ‘‘(4) ADDITIONAL DIRECT COST ADJUST10 MENT.— 

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

12 in addition to adjustments under paragraphs 

13 (1), (2), and (3), further increase the fee rev14 enue and fees— 

15 ‘‘(i) for fiscal year 2018, by 

16 $8,730,000; and 

17 ‘‘(ii) for fiscal year 2019 and subse18 quent fiscal years, by the amount deter19 mined under subparagraph (B). 

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

21 under this subparagraph is— 

22 ‘‘(i) $8,730,000, multiplied by 

23 ‘‘(ii) the Consumer Price Index for 

24 urban consumers (Washington-Baltimore, 

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1 justed; All Items; Annual Index) for the 

2 most recent year of available data, divided 

3 by such Index for 2016. 

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

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

6 fiscal year that begins after September 30, 2017— 

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

8 human drug application fees and prescription 

9 drug program fees under subsection (a), based 

10 on the revenue amounts established under sub11 section (b) and the adjustments provided under 

12 this subsection; and 

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

14 the Federal Register. 

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

16 as adjusted under this subsection, for a fiscal year 

17 may not exceed the total costs for such fiscal year 

18 for the resources allocated for the process for the re19 view of human drug applications.’’. 

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

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

22 379h(d)) is amended— 

23 (1) in paragraph (1)— 

24 (A) by inserting ‘‘or’’ at the end of sub25 paragraph (B); 


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

2 (C) by redesignating subparagraph (D) as 

3 subparagraph (C); 

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

5 standard costs); 

6 (3) by redesignating paragraph (4) as para7 graph (3); and 

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

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

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

11 ‘‘paragraph (1)(C)’’; and 

12 (B) in subparagraph (B)— 

13 (i) by striking clause (ii); 

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

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

16 pay application fees’’; and 

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

18 and inserting a period. 

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

20 736(e) of the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 379h(e)) is amended by striking ‘‘all fees’’ and in22 serting ‘‘all such fees’’. 

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

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

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1 tablishments, and prescription drug products’’ and insert2 ing ‘‘prescription drug program fees’’. 

3 (g) CREDITING AND AVAILABILITY OF FEES.—Sec4 tion 736(g) of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 379h(g)) is amended— 

6 (1) in paragraph (3)— 

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

8 inserting ‘‘2018 through 2022’’; and 

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

10 subsection’’; and 

11 (2) by striking paragraph (4). 

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

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

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

15 each place it appears and inserting ‘‘prescription drug pro16 gram fees’’. 

17 SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 

18 Section 736B of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 379h–2) is amended— 

20 (1) in subsection (a)(1)— 

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

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

23 (B) in subparagraph (A), by striking ‘‘Pre24 scription Drug User Fee Amendments of 2012’’ 


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1 and inserting ‘‘Prescription Drug User Fee 

2 Amendments of 2017’’; 

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

4 inserting ‘‘2018’’; and 

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

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

7 SEC. 104. SUNSET DATES. 

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

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

10 379h) shall cease to be effective October 1, 2022. 

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

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

13 379h–2) shall cease to be effective January 31, 2023. 

14 (c) PREVIOUS SUNSET PROVISION.—Effective Octo15 ber 1, 2017, subsections (a) and (b) of section 105 of the 

16 Food and Drug Administration Safety and Innovation Act 

17 (Public Law 112–144) are repealed. 

18 SEC. 105. EFFECTIVE DATE. 

19 The amendments made by this title shall take effect 

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

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

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

23 and Cosmetic Act shall be assessed for all human drug 

24 applications received on or after October 1, 2017, regard25 less of the date of the enactment of this Act. 


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1 SEC. 106. SAVINGS CLAUSE. 

2 Notwithstanding the amendments made by this title, 

3 part 2 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 human drug applications and 

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

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

9 were accepted by the Food and Drug Administration for 

10 filing with respect to assessing and collecting any fee re11 quired by such part for a fiscal year prior to fiscal year 

12 2018. 

13 TITLE II—FEES RELATING TO 

14 DEVICES 

15 SEC. 201. SHORT TITLE; FINDINGS. 

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

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

18 (b) FINDINGS.—The Congress finds that the fees au19 thorized under the amendments made by this title will be 

20 dedicated toward expediting the process for the review of 

21 device applications and for assuring the safety and effec22 tiveness of devices, as set forth in the goals identified for 

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

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

25 the Secretary of Health and Human Services to the Chair26 man of the Committee on Health, Education, Labor, and 


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1 Pensions of the Senate and the Chairman of the Com2 mittee on Energy and Commerce of the House of Rep3 resentatives, as set forth in the Congressional Record. 

4 SEC. 202. DEFINITIONS. 

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

6 Act (21 U.S.C. 379i) is amended— 

7 (1) by redesignating paragraphs (8) through 

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

9 (2) by inserting after paragraph (7) the fol10 lowing new paragraph: 

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

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

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

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

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

16 submissions’’ and inserting ‘‘submissions, and de 

17 novo classification requests’’; and 

18 (4) in paragraph (11) (as redesignated by para19 graph (1)), by striking ‘‘2011’’ and inserting 

20 ‘‘2016’’. 

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

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

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

24 amended— 


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

2 2013’’ and inserting ‘‘fiscal year 2018’’; and 

3 (2) in paragraph (2)— 

4 (A) in subparagraph (A)— 

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

6 by striking ‘‘October 1, 2012’’ and insert7 ing ‘‘October 1, 2017’’; 

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

9 and inserting ‘‘3.4’’; and 

10 (iii) by adding at the end the fol11 lowing new clause: 

12 ‘‘(xi) For a de novo classification re13 quest, a fee equal to 30 percent of the fee 

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

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

16 ‘‘or premarket notification submission’’ and in17 serting ‘‘premarket notification submission, or 

18 de novo classification request’’. 

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

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

21 amended to read as follows: 

22 ‘‘(b) FEE AMOUNTS.— 

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

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

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1 rived from the base fee amounts specified in para2 graph (2), to generate the total revenue amounts 

3 specified in paragraph (3). 

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

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

6 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 

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

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

9 amounts specified in this paragraph are as follows: 

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

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

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

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

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

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

16 738(c) of the Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 379j(c)) is amended— 

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

19 inserting ‘‘2017’’; 

20 (2) in paragraph (2)— 

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

22 ‘‘2014’’ and inserting ‘‘2018’’; 


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1 (B) by striking subparagraph (B) and in2 serting the following new subparagraph: 

3 ‘‘(B) APPLICABLE INFLATION ADJUST4 MENT.—The applicable inflation adjustment for 

5 fiscal year 2018 and each subsequent fiscal 

6 year is the product of— 

7 ‘‘(i) the base inflation adjustment 

8 under subparagraph (C) for such fiscal 

9 year; and 

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

11 adjustment under subparagraph (C) for 

12 each of the fiscal years preceding such fis13 cal year, beginning with fiscal year 2016.’’; 

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

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

16 and 

17 (D) by amending subparagraph (D) to 

18 read as follows: 

19 ‘‘(D) ADJUSTMENT TO BASE FEE

20 AMOUNTS.—For each of fiscal years 2018 

21 through 2022, the Secretary shall— 

22 ‘‘(i) adjust the base fee amounts spec23 ified in subsection (b)(2) for such fiscal 

24 year by multiplying such amounts by the 


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1 applicable inflation adjustment under sub2 paragraph (B) for such year; and 

3 ‘‘(ii) if the Secretary determines nec4 essary, increase (in addition to the adjust5 ment under clause (i)) such base fee 

6 amounts, on a uniform proportionate basis, 

7 to generate the total revenue amounts 

8 under subsection (b)(3), as adjusted for in9 flation under subparagraph (A).’’; and 

10 (3) in paragraph (3)— 

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

12 inserting ‘‘2018 through 2022’’; and 

13 (B) by striking ‘‘further adjusted’’ and in14 serting ‘‘increased’’. 

15 (d) SMALL BUSINESSES; FEE WAIVER AND FEE RE16 DUCTION REGARDING PREMARKET APPROVAL FEES.— 

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

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

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

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

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

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

23 (2) in paragraph (2)(C)— 

24 (A) by striking ‘‘supplement, or’’ and in25 serting ‘‘supplement,’’; and 


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1 (B) by inserting ‘‘, or a de novo classifica2 tion request’’ after ‘‘class III device’’. 

3 (e) SMALL BUSINESSES; FEE REDUCTION REGARD4 ING PREMARKET NOTIFICATION SUBMISSIONS.—Section 

5 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic 

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

7 ‘‘50’’ and inserting ‘‘25’’. 

8 (f) FEE WAIVER OR REDUCTION.— 

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

10 Drug, and Cosmetic Act (21 U.S.C. 379j) is amend11 ed by striking subsection (f). 

12 (2) CONFORMING CHANGES.— 

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

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

15 360e(c)(4)(A)) is amended by striking ‘‘738(h)’’ 

16 and inserting ‘‘738(g)’’. 

17 (B) Section 738 of the Federal Food, 

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

19 amended by paragraph (1), is further amend20 ed— 

21 (i) by redesignating subsections (g) 

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

23 (ii) in subsection (a)(2)(A), by strik24 ing ‘‘(d), (e), and (f)’’ and inserting ‘‘(d) 

25 and (e)’’; and 


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1 (iii) in subsection (a)(3)(A), by strik2 ing ‘‘and subsection (f)’’. 

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

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

5 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend6 ed— 

7 (1) by striking ‘‘or periodic reporting con8 cerning a class III device’’ and inserting ‘‘periodic 

9 reporting concerning a class III device, or de novo 

10 classification request’’; and 

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

12 such fees’’. 

13 (h) CONDITIONS.—Subsection (g)(1)(A), as redesig14 nated, of section 738 of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 379j) is amended by striking 

16 ‘‘$280,587,000’’ and inserting ‘‘$320,825,000’’. 

17 (i) CREDITING AND AVAILABILITY OF FEES.—Sub18 section (h), as redesignated, of section 738 of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend20 ed— 

21 (1) in paragraph (3)— 

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

23 inserting ‘‘2018 through 2022’’; and 


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

2 that follows through the period at the end and 

3 inserting ‘‘subsection (c).’’; and 

4 (2) by striking paragraph (4). 

5 SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 

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

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

8 379j–1(a)) is amended— 

9 (1) in paragraph (1)— 

10 (A) in subparagraph (A)— 

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

12 ‘‘2018’’; and 

13 (ii) by striking ‘‘the Medical Device 

14 User Fee Amendments of 2012’’ and in15 serting ‘‘Medical Device User Fee Amend16 ments of 2017’’; and 

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

18 Medical Device User Fee Amendments of 

19 2012’’ and inserting ‘‘Medical Device User Fee 

20 Amendments of 2017’’; and 

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

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

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

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

25 1(b)) is amended— 


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

2 inserting ‘‘2022’’; and 

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

4 inserting ‘‘2022’’. 

5 SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 

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

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

8 adding at the end the following: 

9 ‘‘(d) PILOT ACCREDITATION SCHEME FOR CON10 FORMITY ASSESSMENT.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall estab12 lish a pilot program under which— 

13 ‘‘(A) testing laboratories may be accred14 ited, by accreditation bodies meeting criteria 

15 specified by the Secretary, to assess the con16 formance of a device with certain standards rec17 ognized under this section; and 

18 ‘‘(B) subject to paragraph (2), determina19 tions by testing laboratories so accredited that 

20 a device conforms with such standard or stand21 ards shall be accepted by the Secretary for pur22 poses of demonstrating such conformity under 

23 this section unless the Secretary finds that a 

24 particular such determination shall not be so 

25 accepted. 


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1 ‘‘(2) SECRETARIAL REVIEW OF ACCREDITED

2 LABORATORY DETERMINATIONS.—The Secretary 

3 may— 

4 ‘‘(A) review determinations by testing lab5 oratories accredited pursuant to this subsection, 

6 including by conducting periodic audits of such 

7 determinations or processes of accredited bodies 

8 or testing laboratories and, following such re9 view, taking additional measures under this 

10 Act, such as suspension or withdrawal of ac11 creditation of such testing laboratory under 

12 paragraph (1)(A) or requesting additional infor13 mation with respect to such device, as the Sec14 retary determines appropriate; and 

15 ‘‘(B) if the Secretary becomes aware of in16 formation materially bearing on safety or effec17 tiveness of a device assessed for conformity by 

18 a testing laboratory so accredited, take such ad19 ditional measures under this Act as the Sec20 retary determines appropriate, such as suspen21 sion or withdrawal of accreditation of such test22 ing laboratory under paragraph (1)(A), or re23 questing additional information with regard to 

24 such device. 

25 ‘‘(3) IMPLEMENTATION AND REPORTING.— 


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

2 shall publish in the Federal Register a notice of 

3 a public meeting to be held no later than Sep4 tember 30, 2018, to discuss and obtain input 

5 and recommendations from stakeholders regard6 ing the goals and scope of, and a suitable 

7 framework and procedures and requirements 

8 for, the pilot program under this subsection. 

9 ‘‘(B) PILOT PROGRAM GUIDANCE.—The 

10 Secretary shall— 

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

12 2019, issue draft guidance regarding the 

13 goals and implementation of the pilot pro14 gram under this subsection; and 

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

16 2021, issue final guidance with respect to 

17 the implementation of such program. 

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

19 later than September 30, 2020, the Secretary 

20 shall initiate the pilot program under this sub21 section. 

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

23 available on the website of the Food and Drug 

24 Administration an annual report on the 


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1 progress of the pilot program under this sub2 section. 

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

4 ‘‘(A) the authority for accreditation bodies 

5 to accredit testing laboratories pursuant to 

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

7 effect; 

8 ‘‘(B) the Secretary— 

9 ‘‘(i) may not accept a determination 

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

11 testing laboratory after such date; and 

12 ‘‘(ii) may accept such a determination 

13 made prior to such date; 

14 ‘‘(C) except for purposes of accepting a de15 termination described in subparagraph (B)(ii), 

16 the Secretary shall not continue to recognize 

17 the accreditation of testing laboratories accred18 ited under paragraph (1)(A); and 

19 ‘‘(D) the Secretary may take actions in ac20 cordance with paragraph (2) with respect to the 

21 determinations made prior to such date and 

22 recognition of the accreditation of testing lab23 oratories pursuant to determinations made 

24 prior to such date.’’. 


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1 SEC. 206. REAUTHORIZATION OF REVIEW. 

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

3 Act (21 U.S.C. 360m) is amended— 

4 (1) in subsection (a)(3)— 

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

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

7 ‘‘(ii) a device classified under section 

8 513(f)(2) or designated under section 

9 515C(d); or 

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

11 subset of a type, listed as not eligible for 

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

13 (B) by striking subparagraph (B) and in14 serting the following: 

15 ‘‘(B) DESIGNATION FOR REVIEW.—The 

16 Secretary shall— 

17 ‘‘(i) issue draft guidance on the fac18 tors the Secretary will use in determining 

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

20 subset of such device types, is eligible for 

21 review by an accredited person, includ22 ing— 

23 ‘‘(I) the risk of the device type, 

24 or subset of such device type; and 

25 ‘‘(II) whether the device type, or 

26 subset of such device type, is permaVerDate Sep 11 2014 02:53 Apr 26, 2017 Jkt 069200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\S934.IS S934

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1 nently implantable, life sustaining, or 

2 life supporting; 

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

4 the date on which the Secretary issues 

5 such draft guidance, finalize such guid6 ance; and 

7 ‘‘(iii) beginning on the date such guid8 ance is finalized, designate and post on the 

9 Internet website of the Food and Drug Ad10 ministration, an updated list of class I and 

11 class II device types, or subsets of such de12 vice types, and the Secretary’s determina13 tion with respect to whether each such de14 vice type, or subset of a device type, is eli15 gible or not eligible for review by an ac16 credited person under this section based on 

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

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

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

20 which the updated list is designated and posted 

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

22 list in effect on the date of enactment the Med23 ical Device User Fee Amendments of 2017 shall 

24 be in effect.’’; 

25 (2) in subsection (b)— 


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1 (A) in paragraph (2)— 

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

3 (ii) by redesignating subparagraph 

4 (E) as subparagraph (D); and 

5 (B) in paragraph (3)— 

6 (i) by redesignating subparagraph (E) 

7 as subparagraph (F); 

8 (ii) in subparagraph (F) (as so redes9 ignated), by striking ‘‘The operations of’’ 

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

11 and inserting ‘‘Such person shall agree, at 

12 a minimum, to include in its request for 

13 accreditation a commitment to, at the time 

14 of accreditation, and at any time it is per15 forming any review pursuant to this sec16 tion—’’; and 

17 (iii) by inserting after subparagraph 

18 (D) the following new subparagraph: 

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

20 be in accordance with generally accepted profes21 sional and ethical business practices.’’; and 

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

23 inserting ‘‘2022’’. 


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1 SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 

2 Section 745A(b) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 379k–1(b)) is amended by adding 

4 at the end the following new paragraph: 

5 ‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLE6 LY IN ELECTRONIC FORMAT.— 

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

8 1, 2021 (or such later date as may be specified 

9 by the Secretary under subparagraph (B)), 

10 presubmissions and submissions for devices de11 scribed in paragraph (1) (and any appeals of 

12 action taken by the Secretary with respect to 

13 such presubmissions or submissions) shall be 

14 submitted solely in such electronic format as 

15 specified by the Secretary in guidance issued 

16 under subparagraph (C). 

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

18 the Secretary determines an extension of the 

19 date specified in subparagraph (A) is necessary 

20 for the development and adoption of the elec21 tronic format referred to in such paragraph, ex22 tend such date until such later date as the Sec23 retary may specify, but in no event later than 

24 April 1, 2023. 

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

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


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1 as may be specified by the Secretary under sub2 paragraph (B), issue guidance providing for— 

3 ‘‘(i) any further standards for the 

4 submission by electronic format required 

5 under subparagraph (A); 

6 ‘‘(ii) a timetable for the establishment 

7 by the Secretary of such further standards; 

8 and 

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

10 and exemptions from the requirements of 

11 this subsection.’’. 

12 SEC. 208. SAVINGS CLAUSE. 

13 Notwithstanding the amendments made by this title, 

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

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

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

17 title, shall continue to be in effect with respect to the sub18 missions listed in section 738(a)(2)(A) of such Act (as de19 fined in such part as of such day) that on or after October 

20 1, 2012, but before October 1, 2017, were accepted by 

21 the Food and Drug Administration for filing with respect 

22 to assessing and collecting any fee required by such part 

23 for a fiscal year prior to fiscal year 2018. 


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1 SEC. 209. 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 3 of 

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

6 and Cosmetic Act shall be assessed for all submissions list7 ed in section 738(a)(2)(A) of such Act received on or after 

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

9 of this Act. 

10 SEC. 210. SUNSET CLAUSE. 

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

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

13 739j) shall cease to be effective October 1, 2022. 

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

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

16 Act (regarding reauthorization and reporting require17 ments) shall cease to be effective January 31, 2023. 

18 (c) PREVIOUS SUNSET PROVISION.— 

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

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

21 Amendments of 2012 (Public Law 112–144) is re22 pealed. 

23 (2) CONFORMING AMENDMENT.—The Food and 

24 Drug Administration Safety and Innovation Act 

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


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1 contents in section 2 by striking the item relating to 

2 section 207. 

3 TITLE III—FEES RELATING TO 

4 GENERIC DRUGS 

5 SEC. 301. SHORT TITLE; FINDING. 

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

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

8 (b) FINDING.—The Congress finds that the fees au9 thorized by the amendments made in this title will be dedi10 cated to human generic drug activities, as set forth in the 

11 goals identified for purposes of part 7 of subchapter C 

12 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. 302. DEFINITIONS. 

20 Section 744A of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 379j–41) is amended— 

22 (1) in paragraph (1)(B), by striking ‘‘applica23 tion for a positron emission tomography drug.’’ and 

24 inserting ‘‘application— 


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1 ‘‘(i) for a positron emission tomog2 raphy drug; or 

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

4 governmental entity for a drug that is not 

5 distributed commercially.’’; 

6 (2) by redesignating paragraphs (5) through 

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

8 and 

9 (3) by inserting after paragraph (4) the fol10 lowing: 

11 ‘‘(5) The term ‘contract manufacturing organi12 zation facility’ means a manufacturing facility of a 

13 finished dosage form of a drug approved pursuant to 

14 an abbreviated new drug application, where such 

15 manufacturing facility is not identified in an ap16 proved abbreviated new drug application held by the 

17 owner of such facility or an affiliate of such owner 

18 or facility.’’. 

19 SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GE20 NERIC DRUG FEES. 

21 (a) TYPES OF FEES.—Section 744B(a) of the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 

23 42(a)) is amended— 


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

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

3 2018’’; 

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

5 following: 

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

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

8 (3) in paragraph (2)— 

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

10 as follows: 

11 ‘‘(C) NOTICE.—Not later than 60 days be12 fore the start of each of fiscal years 2018 

13 through 2022, the Secretary shall publish in the 

14 Federal Register the amount of the drug mas15 ter file fee established by this paragraph for 

16 such fiscal year.’’; and 

17 (B) in subparagraph (E)— 

18 (i) in clause (i)— 

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

20 date’’ and inserting ‘‘on the earlier 

21 of— 

22 ‘‘(I) the date’’; 

23 (II) by striking the period and 

24 inserting ‘‘; or’’; and 


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1 (III) by adding at the end the 

2 following: 

3 ‘‘(II) the date on which the drug 

4 master file holder requests the initial 

5 completeness assessment.’’; and 

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

7 provided for in clause (i) or (ii) of subpara8 graph (C), as applicable’’ and inserting 

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

10 (4) in paragraph (3)— 

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

12 PRIOR APPROVAL SUPPLEMENT’’; 

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

14 prior approval supplement to an abbreviated 

15 new drug application’’; 

16 (C) by amending subparagraphs (B) and 

17 (C) to read as follows: 

18 ‘‘(B) NOTICE.—Not later than 60 days be19 fore the start of each of fiscal years 2018 

20 through 2022, the Secretary shall publish in the 

21 Federal Register the amount of the fees under 

22 subparagraph (A) for such fiscal year. 

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

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

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1 viated new drug application or prior approval 

2 supplement for which such fee applies.’’; 

3 (D) in subparagraph (D)— 

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

5 WITHDRAWN PRIOR TO BEING RECEIVED, 

6 OR IS NO LONGER RECEIVED’’ after ‘‘RE7 CEIVED’’; and 

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

9 and all that follows through the period and 

10 inserting the following: 

11 ‘‘(i) APPLICATIONS NOT CONSIDERED

12 TO HAVE BEEN RECEIVED AND APPLICA13 TIONS WITHDRAWN PRIOR TO BEING RE14 CEIVED.—The Secretary shall refund 75 

15 percent of the fee paid under subparagraph 

16 (A) for any abbreviated new drug applica17 tion that the Secretary considers not to 

18 have been received within the meaning of 

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

20 failure to pay fees, or that has been with21 drawn prior to being received within the 

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

23 ‘‘(ii) APPLICATIONS NO LONGER RE24 CEIVED.—The Secretary shall refund 100 

25 percent of the fee paid under subparagraph 


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1 (A) for any abbreviated new drug applica2 tion if the Secretary initially receives the 

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

4 subsequently determines that an exclusivity 

5 period for a listed drug should have pre6 vented the Secretary from receiving such 

7 application, such that the abbreviated new 

8 drug application is no longer received with9 in the meaning of section 505(j)(5)(A).’’; 

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

11 prior approval supplement’’; and 

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

13 subparagraph (F)— 

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

15 ‘‘2017’’; and 

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

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

18 (5) in paragraph (4)— 

19 (A) in subparagraph (A)— 

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

21 and in clause (iii), by striking ‘‘, or in22 tended to be identified, in at least one ge23 neric drug submission that is pending or’’ 

24 and inserting ‘‘in at least one generic drug 

25 submission that is’’; 


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1 (ii) in clause (i), by striking ‘‘or in2 tended to be identified in at least one ge3 neric drug submission that is pending or’’ 

4 and inserting ‘‘in at least one generic drug 

5 submission that is’’; 

6 (iii) in clause (ii), by striking ‘‘pro7 duces,’’ and all that follows through ‘‘such 

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

9 one generic drug submission in which the 

10 facility is approved to produce one or more 

11 active pharmaceutical ingredients or in a 

12 Type II active pharmaceutical ingredient 

13 drug master file referenced in at least one 

14 such’’; and 

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

16 under both such clauses’’ and inserting 

17 ‘‘only to the fee attributable to the manu18 facture of the finished dosage forms’’; and 

19 (B) by amending subparagraphs (C) and 

20 (D) to read as follows: 

21 ‘‘(C) NOTICE.—Within the timeframe spec22 ified in subsection (d)(1), the Secretary shall 

23 publish in the Federal Register the amount of 

24 the fees under subparagraph (A) for such fiscal 

25 year.’’. 


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

2 years 2018 through 2022, the fees under sub3 paragraph (A) for such fiscal year shall be due 

4 on the later of— 

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

6 October 1 of each such year; or 

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

8 enactment of an appropriations Act pro9 viding for the collection and obligation of 

10 fees for such year under this section for 

11 such year.’’; 

12 (6) by redesignating paragraph (5) as para13 graph (6); and 

14 (7) by inserting after paragraph (4) the fol15 lowing: 

16 ‘‘(5) GENERIC DRUG APPLICANT PROGRAM

17 FEE.— 

18 ‘‘(A) IN GENERAL.—A generic drug appli19 cant program fee shall be assessed annually as 

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

21 ‘‘(B) AMOUNT.—The amount of fees estab22 lished under subparagraph (A) shall be estab23 lished under subsection (d). 

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 fiscal year; or 

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

11 date of enactment of an appropriations Act 

12 providing for the collection and obligation 

13 of fees for such fiscal year under this sec14 tion for such fiscal year.’’. 

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

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

17 379j–42(b)) is amended— 

18 (1) in paragraph (1)— 

19 (A) in subparagraph (A)— 

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

21 and inserting ‘‘2018’’; 

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

23 ‘‘2018’’; 

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

25 inserting ‘‘$493,600,000’’; and 


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

2 all that follows through the end of clause 

3 (ii); and 

4 (B) in subparagraph (B)— 

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

6 THROUGH 2017’’ and inserting ‘‘2019

7 THROUGH 2022’’; 

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

9 and inserting ‘‘2019 through 2022’’; 

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

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

12 (2) through (5)’’; and 

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

14 inserting ‘‘$493,600,000’’; and 

15 (2) in paragraph (2)— 

16 (A) in the matter preceding subparagraph 

17 (A)— 

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

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

20 for each of fiscal years 2014 through 

21 2017’’ and inserting ‘‘such paragraph for a 

22 fiscal year’’; and 

23 (ii) by striking ‘‘through (4)’’ and in24 serting ‘‘through (5)’’; 


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

2 percent’’ and inserting ‘‘Five percent’’; 

3 (C) by amending subparagraphs (B) and 

4 (C) to read as follows: 

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

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

7 abbreviated new drug applications). 

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

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

10 generic drug facilities). The amount of the fee 

11 for a contract manufacturing organization facil12 ity shall be equal to one-third the amount of the 

13 fee for a facility that is not a contract manufac14 turing organization facility. The amount of the 

15 fee for a facility located outside the United 

16 States and its territories and possessions shall 

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

18 for a facility located in the United States and 

19 its territories and possessions.’’; 

20 (D) in subparagraph (D)— 

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

22 and inserting ‘‘Seven percent’’; 

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

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

25 ‘‘$15,000’’; and 


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

2 all that follows through the period at the 

3 end and inserting a period; and 

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

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

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

7 generic drug applicant program fees). For pur8 poses of this subparagraph, if a person has af9 filiates, a single program fee shall be assessed 

10 with respect to that person, including its affili11 ates, and may be paid by that person or any 

12 one of its affiliates. The Secretary shall deter13 mine the fees as follows: 

14 ‘‘(I) If a person (including its affili15 ates) owns at least one but not more than 

16 5 approved abbreviated new drug applica17 tions on the due date for the fee under this 

18 subsection, the person (including its affili19 ates) shall be assessed a small business ge20 neric drug applicant program fee equal to 

21 one-tenth of the large size operation ge22 neric drug applicant program fee. 

23 ‘‘(II) If a person (including its affili24 ates) owns at least 6 but not more than 19 

25 approved abbreviated new drug applicaVerDate Sep 11 2014 02:53 Apr 26, 2017 Jkt 069200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6201 E:\BILLS\S934.IS S934

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1 tions on the due date for the fee under this 

2 subsection, the person (including its affili3 ates) shall be assessed a medium size oper4 ation generic drug applicant program fee 

5 equal to two-fifths of the large size oper6 ation generic drug applicant program fee. 

7 ‘‘(III) If a person (including its affili8 ates) owns 20 or more approved abbre9 viated new drug applications on the due 

10 date for the fee under this subsection, the 

11 person (including its affiliates) shall be as12 sessed a large size operation generic drug 

13 applicant program fee. 

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

15 an abbreviated new drug application shall be 

16 deemed not to be approved if the applicant has 

17 submitted a written request for withdrawal of 

18 approval of such abbreviated new drug applica19 tion by April 1 of the previous fiscal year.’’. 

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

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

22 amended— 

23 (1) in paragraph (1)— 

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

25 ‘‘2019’’; 


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

2 the total revenues established in such notice for 

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

4 year,’’; and 

5 (C) by striking the flush text following 

6 subparagraph (C); and 

7 (2) in paragraph (2)— 

8 (A) by striking ‘‘2017’’ each place it ap9 pears and inserting ‘‘2022’’; and 

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

11 ‘‘2023’’. 

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

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

14 42) is amended— 

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

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

17 (2) in subsection (d)— 

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

19 inserting the following: 

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

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

22 fiscal years 2018 through 2022, the Secretary shall 

23 establish the fees described in paragraphs (2) 

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


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1 amounts established under subsection (b) and the 

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

3 (B) by redesignating paragraph (3) as 

4 paragraph (2); and 

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

6 in the matter preceding subparagraph (A), by 

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

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

9 (e) IDENTIFICATION OF FACILITIES.—Section 

10 744B(f) of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 379j–42(f)) is amended— 

12 (1) by striking paragraph (1); 

13 (2) by redesignating paragraphs (2) through 

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

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

16 (A) by striking ‘‘paragraph (4)’’ and in17 serting ‘‘paragraph (3)’’; and 

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

19 and all that follows through the end of subpara20 graph (B) and inserting ‘‘Such information 

21 shall, for each fiscal year, be submitted, up22 dated, or reconfirmed on or before June 1 of 

23 the previous fiscal year.’’; and 

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


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

2 OF NOTICE’’ and inserting ‘‘INFORMATION RE3 QUIRED TO BE SUBMITTED’’; 

4 (B) in the matter preceding subparagraph 

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

6 ‘‘paragraph (1)’’; 

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

8 intended to be identified’’; 

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

10 ‘‘and’’ at the end; 

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

12 period and inserting ‘‘; and’’; and 

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

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

15 manufacturing organization facility.’’. 

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

17 744B(g) of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 379–42(g)) is amended— 

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

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

21 on October 1, 2022.’’; 

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

23 505(j)(5)(A)’’ and inserting ‘‘of section 

24 505(j)(5)(A)’’; and 

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


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1 ‘‘(5) GENERIC DRUG APPLICANT PROGRAM

2 FEE.— 

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

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

5 the date that is 20 calendar days after the due 

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

7 subsection, shall be subject to the following: 

8 ‘‘(i) The Secretary shall place the per9 son on a publicly available arrears list. 

10 ‘‘(ii) Any abbreviated new drug appli11 cation submitted by the generic drug appli12 cant or an affiliate of such applicant shall 

13 not be received, within the meaning of sec14 tion 505(j)(5)(A). 

15 ‘‘(iii) All drugs marketed pursuant to 

16 any abbreviated new drug application held 

17 by such applicant or an affiliate of such 

18 applicant shall be deemed misbranded 

19 under section 502(aa). 

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

21 penalties under subparagraph (A) shall apply 

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

23 paid.’’. 

24 (g) LIMITATIONS.—Section 744B(h)(2) of the Fed25 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379– 


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1 42(h)(2)) is amended by striking ‘‘for Type II active phar2 maceutical ingredient drug master files, abbreviated new 

3 drug applications and prior approval supplements, and ge4 neric drug facilities and active pharmaceutical ingredient 

5 facilities’’. 

6 (h) CREDITING AND AVAILABILITY OF FEES.—Sec7 tion 744B(i) of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 379–42(i)) is amended— 

9 (1) in paragraph (2)— 

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

11 to fee collection during first program year); 

12 (B) in subparagraph (D)— 

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

14 SUBSEQUENT YEARS’’; and 

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

16 2013)’’; and 

17 (C) by redesignating subparagraph (D) as 

18 subparagraph (C); and 

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

20 2013 through 2017’’ and inserting ‘‘fiscal years 

21 2018 through 2022’’. 

22 (i) INFORMATION ON ABBREVIATED NEW DRUG AP23 PLICATIONS HELD BY APPLICANTS AND THEIR AFFILI24 ATES.—Section 744B of the Federal Food, Drug, and 


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

2 at the end the following: 

3 ‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG

4 APPLICATIONS OWNED BY APPLICANTS AND THEIR AF5 FILIATES.— 

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

7 each person that owns an abbreviated new drug ap8 plication, or any affiliate of such person, shall sub9 mit to the Secretary a list of— 

10 ‘‘(A) all approved abbreviated new drug 

11 applications owned by such person; and 

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

13 owns an abbreviated new drug application, all 

14 approved abbreviated new drug applications 

15 owned by any such affiliate. 

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

17 shall specify in guidance the format and method for 

18 submission of lists under this subsection.’’. 

19 SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS. 

20 Section 744C of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 379j–43) is amended— 

22 (1) in subsection (a)— 

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

24 ‘‘2018’’; and 


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

2 Amendments of 2012’’ and inserting ‘‘Generic 

3 Drug User Fee Amendments of 2017’’; 

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

5 inserting ‘‘2018’’; and 

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

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

8 SEC. 305. SUNSET DATES. 

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

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

11 379j–41; 379j–42) shall cease to be effective October 1, 

12 2022. 

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

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

15 379j–43) shall cease to be effective January 31, 2023. 

16 (c) PREVIOUS SUNSET PROVISION.—Effective Octo17 ber 1, 2017, subsections (a) and (b) of section 304 of the 

18 Food and Drug Administration Safety and Innovation Act 

19 (Public Law 112–144) are repealed. 

20 SEC. 306. EFFECTIVE DATE. 

21 The amendments made by this title shall take effect 

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

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

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

25 and Cosmetic Act shall be assessed for all abbreviated new 


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

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

3 SEC. 307. SAVINGS CLAUSE. 

4 Notwithstanding the amendments made by this title, 

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

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

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

8 be in effect with respect to abbreviated new drug applica9 tions (as defined in such part as of such day) that on or 

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

11 received by the Food and Drug Administration within the 

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

13 355(j)(5)(A)), prior approval supplements that were sub14 mitted, and drug master files for Type II active pharma15 ceutical ingredients that were first referenced with respect 

16 to assessing and collecting any fee required by such part 

17 for a fiscal year prior to fiscal year 2018. 

18 TITLE IV—FEES RELATING TO 

19 BIOSIMILAR BIOLOGICAL 

20 PRODUCTS 

21 SEC. 401. SHORT TITLE; FINDING. 

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

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

24 (b) FINDING.—The Congress finds that the fees au25 thorized by the amendments made in this title will be dediVerDate Sep 11 2014 02:53 Apr 26, 2017 Jkt 069200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\S934.IS S934

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1 cated to expediting the process for the review of biosimilar 

2 biological product applications, including postmarket safe3 ty activities, as set forth in the goals identified for pur4 poses of part 8 of subchapter C of chapter VII of the Fed5 eral Food, Drug, and Cosmetic Act, in the letters from 

6 the Secretary of Health and Human Services to the Chair7 man of the Committee on Health, Education, Labor, and 

8 Pensions of the Senate and the Chairman of the Com9 mittee on Energy and Commerce of the House of Rep10 resentatives, as set forth in the Congressional Record. 

11 SEC. 402. DEFINITIONS. 

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

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

14 51(1)) is amended to read as follows: 

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

16 a fiscal year is the Consumer Price Index for all 

17 urban consumers (all items; United States city aver18 age) for October of the preceding fiscal year divided 

19 by such Index for October 2011.’’. 

20 (b) BIOSIMILAR BIOLOGICAL PRODUCT.—Section 

21 744G(3) of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 379j–51(3)) is amended by striking ‘‘means 

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

24 a biological product in final dosage form’’. 


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1 SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR 

2 FEES. 

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

5 52(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 the heading of paragraph (1), by striking 

10 ‘‘BIOSIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGI11 CAL PRODUCT’’; 

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

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

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

15 ‘‘(b)(1)(B) for biosimilar biological product develop16 ment’’ and inserting ‘‘(c)(5) for the biosimilar bio17 logical product development program’’; 

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

19 biosimilar biological product development program 

20 fee’’ and inserting ‘‘annual biosimilar biological 

21 product development fee’’; 

22 (6) in paragraph (1)(B)(iii), by striking ‘‘an23 nual biosimilar development program fee’’ and in24 serting ‘‘annual biosimilar biological product devel25 opment fee’’; 


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

2 the following: 

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

4 marketing application for a biosimilar bio5 logical product before October 1 of a fiscal 

6 year and such application is accepted for 

7 filing on or after October 1 of such fiscal 

8 year, the person may request a refund 

9 equal to the annual biosimilar development 

10 fee paid by the person for the product for 

11 such fiscal year. To qualify for consider12 ation for a refund under this clause, a per13 son shall submit to the Secretary a written 

14 request for such refund not later than 180 

15 days after the marketing application is ac16 cepted for filing.’’; 

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

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

19 inserting ‘‘for a product, effective October 1 of a fis20 cal year, by,’’; 

21 (9) in paragraph (1)(D)— 

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

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

24 to resume participation in such program,’’ be25 fore ‘‘pay a fee’’; 


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

2 ‘‘grants a request’’ the following: ‘‘by such per3 son’’; and 

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

5 ‘‘discontinued)’’ the following: ‘‘by such per6 son’’; 

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

8 striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; 

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

10 paragraph (1), by striking ‘‘BIOSIMILAR DEVELOP11 MENT PROGRAM FEES’’ and inserting ‘‘BIOSIMILAR

12 BIOLOGICAL PRODUCT DEVELOPMENT FEES’’; 

13 (12) in paragraph (1)(F)— 

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

15 striking ‘‘BIOSIMILAR DEVELOPMENT PRO16 GRAM’’ before ‘‘FEES’’; and 

17 (B) by amending clause (i) to read as fol18 lows: 

19 ‘‘(i) REFUNDS.—Except as provided 

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

21 shall not refund any initial or annual bio22 similar biological product development fee 

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

24 any reactivation fee paid under subpara25 graph (D).’’; 


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1 (13) in paragraph (2)— 

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

3 striking ‘‘AND SUPPLEMENT’’; 

4 (B) by amending subparagraphs (A) and 

5 (B) to read as follows: 

6 ‘‘(A) IN GENERAL.—Each person that sub7 mits, on or after October 1, 2017, a biosimilar 

8 biological product application shall be subject to 

9 the following fees: 

10 ‘‘(i) A fee established under sub11 section (c)(5) for a biosimilar biological 

12 product application for which clinical data 

13 (other than comparative bioavailability 

14 studies) with respect to safety or effective15 ness are required for approval. 

16 ‘‘(ii) A fee established under sub17 section (c)(5) for a biosimilar biological 

18 product application for which clinical data 

19 (other than comparative bioavailability 

20 studies) with respect to safety or effective21 ness are not required for approval. Such 

22 fee shall be equal to half of the amount of 

23 the fee described in clause (i). 

24 ‘‘(B) RULE OF APPLICABILITY; TREAT25 MENT OF CERTAIN PREVIOUSLY PAID FEES.— 


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1 Any person who pays a fee under subparagraph 

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

3 before October 1, 2017, but submits a bio4 similar biological product application for that 

5 product after such date, shall— 

6 ‘‘(i) be subject to any biosimilar bio7 logical product application fees that may 

8 be assessed at the time when such bio9 similar biological product application is 

10 submitted; and 

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

12 such application fees based on the amount 

13 of fees paid for that product before Octo14 ber 1, 2017, under such subparagraph (A), 

15 (B), or (D).’’; 

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

17 by striking ‘‘OR SUPPLEMENT’’; and 

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

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

20 place it appears; and 

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

22 ‘‘or a supplement’’; and 

23 (14) by amending paragraph (3) to read as fol24 lows: 


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1 ‘‘(3) BIOSIMILAR BIOLOGICAL PRODUCT PRO2 GRAM FEE.— 

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

4 named as the applicant in a biosimilar biologi5 cal product application shall pay the annual bio6 similar biological product program fee estab7 lished for a fiscal year under subsection (c)(5) 

8 for each biosimilar biological product that— 

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

10 biological product application approved as 

11 of October 1 of such fiscal year; and 

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

13 year, does not appear on a list, developed 

14 and maintained by the Secretary, of dis15 continued biosimilar biological products. 

16 ‘‘(B) DUE DATE.—The biosimilar biologi17 cal product program fee for a fiscal year shall 

18 be due on the later of— 

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

20 October 1 of each such year; or 

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

22 enactment of an appropriations Act pro23 viding for the collection and obligation of 

24 fees for such year under this section. 


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

2 The biosimilar biological product program fee 

3 shall be paid only once for each product for 

4 each fiscal year. 

5 ‘‘(D) LIMITATION.—A person who is 

6 named as the applicant in a biosimilar biologi7 cal product application shall not be assessed 

8 more than 5 biosimilar biological product pro9 gram fees for a fiscal year for biosimilar bio10 logical products identified in such biosimilar bi11 ological product application.’’. 

12 (b) FEE REVENUE AMOUNTS.—Subsection (b) of sec13 tion 744H of the Federal Food, Drug, and Cosmetic Act 

14 (21 U.S.C. 379j–52) is amended to read as follows: 

15 ‘‘(b) FEE REVENUE AMOUNTS.— 

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

17 fees under subsection (a) shall be established to gen18 erate a total revenue amount equal to the sum of— 

19 ‘‘(A) $45,000,000; and 

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

21 year 2018 adjustment (as determined under 

22 subsection (c)(4)). 

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

24 the fiscal years 2019 through 2022, fees under sub25 section (a) shall, except as provided in subsection 


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

2 amount equal to the sum of— 

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

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

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

8 ‘‘(C) the dollar amount equal to the capac9 ity planning adjustment for the fiscal year (as 

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

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

13 applicable (as determined under subsection 

14 (c)(3)). 

15 ‘‘(3) ALLOCATION OF REVENUE AMOUNT

16 AMONG FEES; LIMITATIONS ON FEE AMOUNTS.— 

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

18 determine the percentage of the total revenue 

19 amount for a fiscal year to be derived from, re20 spectively— 

21 ‘‘(i) initial and annual biosimilar de22 velopment fees and reactivation fees under 

23 subsection (a)(1); 

24 ‘‘(ii) biosimilar biological product ap25 plication fees under subsection (a)(2); and 


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1 ‘‘(iii) biosimilar biological product pro2 gram fees under subsection (a)(3). 

3 ‘‘(B) LIMITATIONS ON FEE AMOUNTS.— 

4 Until the first fiscal year for which the capacity 

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

6 effective, the amount of any fee under sub7 section (a) for a fiscal year after fiscal year 

8 2018 shall not exceed 125 percent of the 

9 amount of such fee for fiscal year 2018. 

10 ‘‘(C) BIOSIMILAR BIOLOGICAL PRODUCT

11 DEVELOPMENT FEES.—The initial biosimilar bi12 ological product development fee under sub13 section (a)(1)(A) for a fiscal year shall be equal 

14 to the annual biosimilar biological product de15 velopment fee under subsection (a)(1)(B) for 

16 that fiscal year. 

17 ‘‘(D) REACTIVATION FEE.—The reactiva18 tion fee under subsection (a)(1)(D) for a fiscal 

19 year shall be equal to twice the amount of the 

20 annual biosimilar biological product develop21 ment fee under subsection (a)(1)(B) for that 

22 fiscal year. 

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

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

25 base revenue for a fiscal year shall be the dollar 


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1 amount of the total revenue amount for the previous 

2 fiscal year, excluding any adjustments to such rev3 enue amount under subsection (c)(3).’’. 

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

5 744H of the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 379j–52) is amended— 

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

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

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

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

11 (3) in subsection (a)(4)(A), by striking ‘‘sub12 section (b)(1)(F)’’ and inserting ‘‘subsection (c)(5)’’; 

13 and 

14 (4) by inserting after subsection (b) the fol15 lowing: 

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

17 ‘‘(1) INFLATION ADJUSTMENT.— 

18 ‘‘(A) IN GENERAL.—For purposes of sub19 section (b)(2)(B), the dollar amount of the in20 flation adjustment to the annual base revenue 

21 for each fiscal year shall be equal to the prod22 uct of— 

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

24 fiscal year under subsection (b); and 


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

3 ‘‘(B) INFLATION ADJUSTMENT PERCENT4 AGE.—The inflation adjustment percentage 

5 under this subparagraph for a fiscal year is 

6 equal to the sum of— 

7 ‘‘(i) the average annual percent 

8 change in the cost, per full-time equivalent 

9 position of the Food and Drug Administra10 tion, of all personnel compensation and 

11 benefits paid with respect to such positions 

12 for the first 3 years of the preceding 4 fis13 cal years, multiplied by the proportion of 

14 personnel compensation and benefits costs 

15 to total costs of the process for the review 

16 of biosimilar biological product applications 

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

18 first 3 years of the preceding 4 fiscal 

19 years; and 

20 ‘‘(ii) the average annual percent 

21 change that occurred in the Consumer 

22 Price Index for urban consumers (Wash23 ington-Baltimore, DC–MD–VA–WV; Not 

24 Seasonally Adjusted; All items; Annual 

25 Index) for the first 3 years of the preVerDate Sep 11 2014 02:53 Apr 26, 2017 Jkt 069200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\S934.IS S934

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1 ceding 4 years of available data multiplied 

2 by the proportion of all costs other than 

3 personnel compensation and benefits costs 

4 to total costs of the process for the review 

5 of biosimilar biological product applications 

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

7 first 3 years of the preceding 4 fiscal 

8 years. 

9 ‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 

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

11 fiscal year described in subparagraph 

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

13 the adjustment under paragraph (1), further in14 crease the fee revenue and fees under this sec15 tion for a fiscal year to reflect changes in the 

16 resource capacity needs of the Secretary for the 

17 process for the review of biosimilar biological 

18 product applications. 

19 ‘‘(B) CAPACITY PLANNING METHOD20 OLOGY.— 

21 ‘‘(i) DEVELOPMENT; EVALUATION

22 AND REPORT.—The Secretary shall obtain, 

23 through a contract with an independent ac24 counting or consulting firm, a report evalu25 ating options and recommendations for a 


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1 new methodology to accurately assess 

2 changes in the resource and capacity needs 

3 of the process for the review of biosimilar 

4 biological product applications. The capac5 ity planning methodological options and 

6 recommendations presented in such report 

7 shall utilize and be informed by personnel 

8 time reporting data as an input. The re9 port shall be published for public comment 

10 not later than September 30, 2020. 

11 ‘‘(ii) ESTABLISHMENT AND IMPLE12 MENTATION.—After review of the report 

13 described in clause (i) and receipt and re14 view of public comments thereon, the Sec15 retary shall establish a capacity planning 

16 methodology for purposes of this para17 graph, which shall— 

18 ‘‘(I) incorporate such approaches 

19 and attributes as the Secretary deter20 mines appropriate; and 

21 ‘‘(II) be effective beginning with 

22 the first fiscal year for which fees are 

23 set after such capacity planning meth24 odology is established. 


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1 ‘‘(C) LIMITATION.—Under no cir2 cumstances shall an adjustment under this 

3 paragraph result in fee revenue for a fiscal year 

4 that is less than the sum of the amounts under 

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

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

7 amount of the inflation adjustment for the fis8 cal year). 

9 ‘‘(D) PUBLICATION IN FEDERAL REG10 ISTER.—The Secretary shall publish in the Fed11 eral Register notice under paragraph (5) the fee 

12 revenue and fees resulting from the adjustment 

13 and the methodologies under this paragraph. 

14 ‘‘(3) OPERATING RESERVE ADJUSTMENT.— 

15 ‘‘(A) INTERIM APPLICATION; FEE REDUC16 TION.—Until the first fiscal year for which the 

17 capacity planning adjustment under paragraph 

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

19 to the adjustment under paragraph (1), reduce 

20 the fee revenue and fees under this section for 

21 a fiscal year as the Secretary determines appro22 priate for long-term financial planning pur23 poses. 

24 ‘‘(B) GENERAL APPLICATION AND METH25 ODOLOGY.—Beginning with the first fiscal year 


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1 for which the capacity planning adjustment 

2 under paragraph (2) is effective, the Secretary 

3 may, in addition to the adjustments under 

4 paragraphs (1) and (2)— 

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

6 under this section as the Secretary deter7 mines appropriate for long-term financial 

8 planning purposes; or 

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

10 under this section if such an adjustment is 

11 necessary to provide for not more than 21 

12 weeks of operating reserves of carryover 

13 user fees for the process for the review of 

14 biosimilar biological product applications. 

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

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

17 made, the rationale for the amount of the in18 crease or decrease (as applicable) in fee revenue 

19 and fees shall be contained in the annual Fed20 eral Register notice under paragraph (5) estab21 lishing fee revenue and fees for the fiscal year 

22 involved. 

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

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

25 the Secretary shall adjust the fee revenue and 


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

2 as needed to reflect an updated assessment of 

3 the workload for the process for the review of 

4 biosimilar biological product applications. 

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

6 publish under paragraph (5) a description of 

7 the methodology used to calculate the fiscal 

8 year 2018 adjustment under this paragraph in 

9 the Federal Register notice establishing fee rev10 enue and fees for fiscal year 2018. 

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

12 this paragraph shall result in an increase in fee 

13 revenue and fees under this section in excess of 

14 $9,000,000. 

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

16 2018 and each subsequent fiscal year, the Secretary 

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

18 such fiscal year— 

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

20 and annual biosimilar biological product devel21 opment fees and reactivation fees under sub22 section (a)(1), biosimilar biological product ap23 plication fees under subsection (a)(2), and bio24 similar biological product program fees under 

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


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1 amounts established under subsection (b) and 

2 the adjustments provided under this subsection; 

3 and 

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

5 the Federal Register. 

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

7 for a fiscal year under this section may not exceed 

8 the total costs for such fiscal year for the resources 

9 allocated for the process for the review of biosimilar 

10 biological product applications.’’. 

11 (d) APPLICATION FEE WAIVER FOR SMALL BUSI12 NESS.—Subsection (d)(1) of section 744H of the Federal 

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

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

15 (1) by striking subparagraph (B); 

16 (2) by striking ‘‘shall pay—’’ and all that fol17 lows through ‘‘application fees’’ and inserting ‘‘shall 

18 pay application fees’’; and 

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

20 a period. 

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

22 (e) of section 744H of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 379j–52), as redesignated by sub24 section (c)(1), is amended by striking ‘‘all fees’’ and in25 serting ‘‘all such fees’’. 


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1 (f) CREDITING AND AVAILABILITY OF FEES.—Sub2 section (f) of section 744H of the Federal Food, Drug, 

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

4 by subsection (c)(1), is amended— 

5 (1) in paragraph (2)— 

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

7 to fee collection during first program year) and 

8 inserting the following: 

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

10 be considered to have met the requirements of 

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

12 described in such subparagraph are not more 

13 than 15 percent below the level specified in 

14 such subparagraph.’’; and 

15 (B) in subparagraph (D)— 

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

17 SUBSEQUENT YEARS’’; and 

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

19 2013)’’; and 

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

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

22 SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 

23 Section 744I of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 379j–53) 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 ‘‘Biosimilar User Fee Act 

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

5 Amendments of 2017’’; 

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

7 inserting ‘‘2018’’; 

8 (3) by striking subsection (d); 

9 (4) by redesignating subsection (e) as sub10 section (d); and 

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

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

13 ‘‘2022’’. 

14 SEC. 405. SUNSET DATES. 

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

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

17 by section 403 of this Act, shall cease to be effective Octo18 ber 1, 2022. 

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

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

21 by section 404 of this Act, shall cease to be effective Janu22 ary 31, 2023. 

23 (c) PREVIOUS SUNSET PROVISION.— 

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

25 section 404 of the Food and Drug Administration 


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

2 repealed. 

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 404. 

8 SEC. 406. 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 8 of 

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

13 and Cosmetic Act shall be assessed for all biosimilar bio14 logical product applications received on or after October 

15 1, 2017, regardless of the date of the enactment of this 

16 Act. 

17 SEC. 407. SAVINGS CLAUSE. 

18 Notwithstanding the amendments made by this title, 

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

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

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

22 be in effect with respect to biosimilar biological product 

23 applications and supplements (as defined in such part as 

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

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


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1 before October 1, 2017, with respect to assessing and col2 lecting any fee required by such part for a fiscal year prior 

3 to fiscal year 2018. 

4 TITLE V—REAUTHORIZATION OF 

5 OTHER PROGRAMS 

6 SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO 

7 EXCLUSIVITY OF CERTAIN DRUGS CON8 TAINING SINGLE ENANTIOMERS. 

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

10 Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by strik11 ing ‘‘2017’’ and inserting ‘‘2022’’. 

12 SEC. 502. REAUTHORIZATION OF PEDIATRIC HUMANI13 TARIAN DEVICE EXCEPTIONS. 

14 Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 

16 amended by striking ‘‘2017’’ and inserting ‘‘2022’’. 

17 SEC. 503. REAUTHORIZATION OF THE CRITICAL PATH PUB18 LIC-PRIVATE PARTNERSHIPS. 

19 Section 566(f) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 

21 ‘‘2013 through 2017’’ and inserting ‘‘2018 through 

22 2022’’. 


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1 SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE CON2 SORTIA. 

3 Section 305(e) of Pediatric Medical Device Safety 

4 and Improvement Act of 2007 (Public Law 110–85; 42 

5 U.S.C. 282 note) is amended by striking ‘‘2013 through 

6 2017’’ and inserting ‘‘2018 through 2022’’. 

7 SEC. 505. REAUTHORIZATION OF ORPHAN GRANTS PRO8 GRAM. 

9 Section 5(c) of the Orphan Drug Act (21 U.S.C. 

10 360ee(c)) is amended by striking ‘‘2013 through 2017’’ 

11 and inserting ‘‘2018 through 2022’’. 

Æ 


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