tions on the due date for the fee under this 
subsection, the person (including its affili-
ates) shall be assessed a medium size oper-
ation generic drug applicant program fee 
equal to two-fifths of the large size oper-
ation generic drug applicant program fee. 
‘‘(III) If a person (including its affili-
ates) owns 20 or more approved abbre-
viated new drug applications on the due 
date for the fee under this subsection, the 
person (including its affiliates) shall be as-
sessed a large size operation generic drug 
applicant program fee. 
‘‘(ii) For purposes of this subparagraph, 
an abbreviated new drug application shall be 
deemed not to be approved if the applicant has 
submitted a written request for withdrawal of 
approval of such abbreviated new drug applica-
tion by April 1 of the previous fiscal year.’’. 
(c) ADJUSTMENTS.—Section 744B(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is 
amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘2014’’ and inserting 
‘‘2019’’; 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00051
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(B) by inserting ‘‘to equal the product of 
the total revenues established in such notice for 
the prior fiscal year multiplied’’ after ‘‘a fiscal 
year,’’; and 
(C) by striking the flush text following 
subparagraph (C); and 
(2) in paragraph (2)— 
(A) by striking ‘‘2017’’ each place it ap-
pears and inserting ‘‘2022’’; 
(B) by striking ‘‘the first 3 months of fis-
cal year 2018’’ and inserting ‘‘the first 3 
months of fiscal year 2023’’; and 
(C) by striking ‘‘Such fees may only be 
used in fiscal year 2018.’’. 
(d) ANNUAL FEE SETTING.—Section 744B(d) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
42(d)) is amended— 
(1) by striking paragraphs (1) and (2) and in-
serting the following: 
‘‘(1) FISCAL YEARS 2018 THROUGH 2022.—Not 
more than 60 days before the first day of each of 
fiscal years 2018 through 2022, the Secretary shall 
establish the fees described in paragraphs (2) 
through (5) of subsection (a), based on the revenue 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00052
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
amounts established under subsection (b) and the 
adjustments provided under subsection (c).’’; 
(2) by redesignating paragraph (3) as para-
graph (2); and 
(3) in paragraph (2) (as so redesignated), in 
the matter preceding subparagraph (A), by striking 
‘‘fees under paragraphs (1) and (2)’’ and inserting 
‘‘fee under paragraph (1)’’. 
(e) 
IDENTIFICATION
OF
FACILITIES.—Section 
744B(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–42(f)) is amended— 
(1) by striking paragraph (1); 
(2) by redesignating paragraphs (2) through 
(4) as paragraphs (1) through (3), respectively; 
(3) in paragraph (1) (as so redesignated)— 
(A) by striking ‘‘paragraph (4)’’ and in-
serting ‘‘paragraph (3)’’; and 
(B) by striking ‘‘Such information shall’’ 
and all that follows through the end of subpara-
graph (B) and inserting ‘‘Such information 
shall, for each fiscal year, be submitted, up-
dated, or reconfirmed on or before June 1 of 
the previous fiscal year.’’; and 
(4) in paragraph (2), as so redesignated— 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00053
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(A) in the heading, by striking ‘‘CONTENTS 
OF NOTICE’’ and inserting ‘‘INFORMATION RE-
QUIRED TO BE SUBMITTED’’; 
(B) in the matter preceding subparagraph 
(A), by striking ‘‘paragraph (2)’’ and inserting 
‘‘paragraph (1)’’; 
(C) in subparagraph (A), by striking ‘‘or 
intended to be identified’’; 
(D) in subparagraph (D), by striking 
‘‘and’’ at the end; 
(E) in subparagraph (E), by striking the 
period and inserting ‘‘; and’’; and 
(F) by adding at the end the following: 
‘‘(F) whether the facility is a contract 
manufacturing organization facility.’’. 
(f) EFFECT OF FAILURE TO PAY FEES.—Section 
744B(g) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379–42(g)) is amended— 
(1) in paragraph (1), by adding at the end the 
following: ‘‘This paragraph shall cease to be effective 
on October 1, 2022.’’; 
(2) in paragraph (2)(C)(ii), by striking ‘‘of 
505(j)(5)(A)’’ 
and 
inserting 
‘‘of 
section 
505(j)(5)(A)’’; and 
(3) by adding at the end the following: 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00054
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
‘‘(5) GENERIC
DRUG
APPLICANT
PROGRAM 
FEE.— 
‘‘(A) IN GENERAL.—A person who fails to 
pay a fee as required under subsection (a)(5) by 
the date that is 20 calendar days after the due 
date, as specified in subparagraph (D) of such 
subsection, shall be subject to the following: 
‘‘(i) The Secretary shall place the per-
son on a publicly available arrears list. 
‘‘(ii) Any abbreviated new drug appli-
cation submitted by the generic drug appli-
cant or an affiliate of such applicant shall 
not be received, within the meaning of sec-
tion 505(j)(5)(A). 
‘‘(iii) All drugs marketed pursuant to 
any abbreviated new drug application held 
by such applicant or an affiliate of such 
applicant shall be deemed misbranded 
under section 502(aa). 
‘‘(B) APPLICATION
OF
PENALTIES.—The 
penalties under subparagraph (A) shall apply 
until the fee required under subsection (a)(5) is 
paid.’’. 
(g) LIMITATIONS.—Section 744B(h)(2) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379– 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00055
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
42(h)(2)) is amended by striking ‘‘for Type II active phar-
maceutical ingredient drug master files, abbreviated new 
drug applications and prior approval supplements, and ge-
neric drug facilities and active pharmaceutical ingredient 
facilities’’. 
(h) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 744B(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379–42(i)) is amended— 
(1) in paragraph (2)— 
(A) by striking subparagraph (C) (relating 
to fee collection during first program year); 
(B) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN 
SUBSEQUENT YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 
2013)’’; and 
(C) by redesignating subparagraph (D) as 
subparagraph (C); and 
(2) in paragraph (3), by striking ‘‘fiscal years 
2013 through 2017’’ and inserting ‘‘fiscal years 
2018 through 2022’’. 
(i) INFORMATION ON ABBREVIATED NEW DRUG AP-
PLICATIONS OWNED BY APPLICANTS AND THEIR AFFILI-
ATES.—Section 744B of the Federal Food, Drug, and 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00056
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
Cosmetic Act (21 U.S.C. 379–42) is amended by adding 
at the end the following: 
‘‘(o) INFORMATION ON ABBREVIATED NEW DRUG 
APPLICATIONS OWNED BY APPLICANTS AND THEIR AF-
FILIATES.— 
‘‘(1) IN GENERAL.—By April 1 of each year, 
each person that owns an abbreviated new drug ap-
plication, or any affiliate of such person, shall sub-
mit, on behalf of the person and its affiliates, to the 
Secretary a list of— 
‘‘(A) all approved abbreviated new drug 
applications owned by such person; and 
‘‘(B) if any affiliate of such person also 
owns an abbreviated new drug application, all 
affiliates that own any such abbreviated new 
drug applications and all approved abbreviated 
new drug applications owned by any such affil-
iate. 
‘‘(2) FORMAT
AND
METHOD.—The Secretary 
shall specify in guidance the format and method for 
submission of lists under this subsection.’’. 
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744C of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–43) is amended— 
(1) in subsection (a)— 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00057
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(A) by striking ‘‘2013’’ and inserting 
‘‘2018’’; and 
(B) by striking ‘‘Generic Drug User Fee 
Amendments of 2012’’ and inserting ‘‘Generic 
Drug User Fee Amendments of 2017’’; 
(2) in subsection (b), by striking ‘‘2013’’ and 
inserting ‘‘2018’’; and 
(3) in subsection (d), by striking ‘‘2017’’ each 
place it appears and inserting ‘‘2022’’. 
SEC. 305. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744A and 744B of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–41; 379j–42) shall cease to be effective October 1, 
2022. 
(b) REPORTING REQUIREMENTS.—Section 744C of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–43) shall cease to be effective January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
ber 1, 2017, subsections (a) and (b) of section 304 of the 
Food and Drug Administration Safety and Innovation Act 
(Public Law 112–144) are repealed. 
SEC. 306. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2017, or the date of the enactment of this 
Act, whichever is later, except that fees under part 7 of 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00058
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all abbreviated new 
drug applications received on or after October 1, 2017, 
regardless of the date of the enactment of this Act. 
SEC. 307. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 7 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
the date of the enactment of this title, shall continue to 
be in effect with respect to abbreviated new drug applica-
tions (as defined in such part as of such day) that on or 
after October 1, 2012, but before October 1, 2017, were 
received by the Food and Drug Administration within the 
meaning of 505(j)(5)(A) of such Act (21 U.S.C. 
355(j)(5)(A)), prior approval supplements that were sub-
mitted, and drug master files for Type II active pharma-
ceutical ingredients that were first referenced with respect 
to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2018. 
TITLE IV—FEES RELATING TO 
BIOSIMILAR 
BIOLOGICAL 
PRODUCTS 
SEC. 401. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Biosimilar User Fee Amendments of 2017’’. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00059
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated to expediting the process for the review of biosimilar 
biological product applications, including postmarket safe-
ty activities, as set forth in the goals identified for pur-
poses of part 8 of subchapter C of chapter VII of the Fed-
eral Food, Drug, and Cosmetic Act, in the letters from 
the Secretary of Health and Human Services to the Chair-
man of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives, as set forth in the Congressional Record. 
SEC. 402. DEFINITIONS. 
(a) ADJUSTMENT FACTOR.—Section 744G(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
51(1)) is amended to read as follows: 
‘‘(1) The term ‘adjustment factor’ applicable to 
a fiscal year is the Consumer Price Index for urban 
consumers (Washington-Baltimore, DC-MD-VA-WV; 
Not Seasonally Adjusted; All items; Annual Index) 
for October of the preceding fiscal year divided by 
such Index for October 2011.’’. 
(b) BIOSIMILAR
BIOLOGICAL
PRODUCT.—Section 
744G(3) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–51(3)) is amended by striking ‘‘means 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00060
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
a product’’ and inserting ‘‘means a specific strength of 
a biological product in final dosage form’’. 
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
FEES. 
(a) TYPES OF FEES.—Section 744H(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(a)) is amended— 
(1) in the matter preceding paragraph (1), by 
striking ‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 
2018’’; 
(2) in the heading of paragraph (1), by striking 
‘‘BIOSIMILAR’’ and inserting ‘‘BIOSIMILAR BIOLOGI-
CAL PRODUCT’’; 
(3) 
in 
paragraph 
(1)(A)(i), 
by 
striking 
‘‘(b)(1)(A)’’ and inserting ‘‘(c)(5)’’; 
(4) 
in 
paragraph 
(1)(B)(i), 
by 
striking 
‘‘(b)(1)(B) for biosimilar biological product develop-
ment’’ and inserting ‘‘(c)(5) for the biosimilar bio-
logical product development program’’; 
(5) in paragraph (1)(B)(ii), by striking ‘‘annual 
biosimilar biological product development program 
fee’’ and inserting ‘‘annual biosimilar biological 
product development fee’’; 
(6) in paragraph (1)(B)(iii), by striking ‘‘an-
nual biosimilar development program fee’’ and in-
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00061
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
serting ‘‘annual biosimilar biological product devel-
opment fee’’; 
(7) in paragraph (1)(B), by adding at the end 
the following: 
‘‘(iv) REFUND.—If a person submits a 
marketing application for a biosimilar bio-
logical product before October 1 of a fiscal 
year and such application is accepted for 
filing on or after October 1 of such fiscal 
year, the person may request a refund 
equal to the annual biosimilar development 
fee paid by the person for the product for 
such fiscal year. To qualify for consider-
ation for a refund under this clause, a per-
son shall submit to the Secretary a written 
request for such refund not later than 180 
days after the marketing application is ac-
cepted for filing.’’; 
(8) in paragraph (1)(C), by striking ‘‘for a 
product effective October 1 of a fiscal year by,’’ and 
inserting ‘‘for a product, effective October 1 of a fis-
cal year, by,’’; 
(9) in paragraph (1)(D)— 
(A) in clause (i) in the matter preceding 
subclause (I), by inserting ‘‘, if the person seeks 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00062
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
to resume participation in such program,’’ be-
fore ‘‘pay a fee’’; 
(B) in clause (i)(I), by inserting after 
‘‘grants a request’’ the following: ‘‘by such per-
son’’; and 
(C) in clause (i)(II), by inserting after 
‘‘discontinued)’’ the following: ‘‘by such per-
son’’; 
(10) in the heading of paragraph (1)(E), by 
striking ‘‘BIOSIMILAR DEVELOPMENT PROGRAM’’; 
(11) in the heading of subparagraph (F) of 
paragraph (1), by striking ‘‘BIOSIMILAR DEVELOP-
MENT PROGRAM FEES’’ and inserting ‘‘BIOSIMILAR 
BIOLOGICAL PRODUCT DEVELOPMENT FEES’’; 
(12) in paragraph (1)(F)— 
(A) in the heading of subparagraph (F), by 
striking 
‘‘BIOSIMILAR
DEVELOPMENT
PRO-
GRAM’’ before ‘‘FEES’’; and 
(B) by amending clause (i) to read as fol-
lows: 
‘‘(i) REFUNDS.—Except as provided 
in subparagraph (B)(iv), the Secretary 
shall not refund any initial or annual bio-
similar biological product development fee 
paid under subparagraph (A) or (B), or 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00063
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
any reactivation fee paid under subpara-
graph (D).’’; 
(13) in paragraph (2)— 
(A) in the heading of paragraph (2), by 
striking ‘‘AND SUPPLEMENT’’; 
(B) by amending subparagraphs (A) and 
(B) to read as follows: 
‘‘(A) IN GENERAL.—Each person that sub-
mits, on or after October 1, 2017, a biosimilar 
biological product application shall be subject to 
the following fees: 
‘‘(i) A fee established under sub-
section (c)(5) for a biosimilar biological 
product application for which clinical data 
(other than comparative bioavailability 
studies) with respect to safety or effective-
ness are required for approval. 
‘‘(ii) A fee established under sub-
section (c)(5) for a biosimilar biological 
product application for which clinical data 
(other than comparative bioavailability 
studies) with respect to safety or effective-
ness are not required for approval. Such 
fee shall be equal to half of the amount of 
the fee described in clause (i). 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00064
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(14) by amending paragraph (3) to read as fol-
lows: 
‘‘(3) BIOSIMILAR
BIOLOGICAL
PRODUCT
PRO-
GRAM FEE.— 
‘‘(A) IN GENERAL.—Each person who is 
named as the applicant in a biosimilar biologi-
cal product application shall pay the annual bio-
similar biological product program fee estab-
lished for a fiscal year under subsection (c)(5) 
for each biosimilar biological product that— 
‘‘(i) is identified in such a biosimilar 
biological product application approved as 
of October 1 of such fiscal year; and 
‘‘(ii) as of October 1 of such fiscal 
year, does not appear on a list, developed 
and maintained by the Secretary, of dis-
continued biosimilar biological products. 
‘‘(B) DUE DATE.—The biosimilar biologi-
cal product program fee for a fiscal year shall 
be due on the later of— 
‘‘(i) the first business day on or after 
October 1 of each such year; or 
‘‘(ii) the first business day after the 
enactment of an appropriations Act pro-
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00066
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
viding for the collection and obligation of 
fees for such year under this section. 
‘‘(C) ONE FEE PER PRODUCT PER YEAR.— 
The biosimilar biological product program fee 
shall be paid only once for each product for 
each fiscal year. 
‘‘(D) LIMITATION.—A person who is 
named as the applicant in a biosimilar biologi-
cal product application shall not be assessed 
more than 5 biosimilar biological product pro-
gram fees for a fiscal year for biosimilar bio-
logical products identified in such biosimilar bi-
ological product application.’’. 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 744H of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–52) is amended to read as follows: 
‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) FISCAL YEAR 2018.—For fiscal year 2018, 
fees under subsection (a) shall be established to gen-
erate a total revenue amount equal to the sum of— 
‘‘(A) $45,000,000; and 
‘‘(B) the dollar amount equal to the fiscal 
year 2018 adjustment (as determined under 
subsection (c)(4)). 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00067
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
‘‘(2) SUBSEQUENT FISCAL YEARS.—For each of 
the fiscal years 2019 through 2022, fees under sub-
section (a) shall, except as provided in subsection 
(c), be established to generate a total revenue 
amount equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal 
year (as determined under paragraph (4)); 
‘‘(B) the dollar amount equal to the infla-
tion adjustment for the fiscal year (as deter-
mined under subsection (c)(1)); 
‘‘(C) the dollar amount equal to the capac-
ity planning adjustment for the fiscal year (as 
determined under subsection (c)(2)); and 
‘‘(D) the dollar amount equal to the oper-
ating reserve adjustment for the fiscal year, if 
applicable (as determined under subsection 
(c)(3)). 
‘‘(3) 
ALLOCATION
OF
REVENUE
AMOUNT 
AMONG FEES; LIMITATIONS ON FEE AMOUNTS.— 
‘‘(A) ALLOCATION.—The Secretary shall 
determine the percentage of the total revenue 
amount for a fiscal year to be derived from, re-
spectively— 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00068
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
‘‘(i) initial and annual biosimilar de-
velopment fees and reactivation fees under 
subsection (a)(1); 
‘‘(ii) biosimilar biological product ap-
plication fees under subsection (a)(2); and 
‘‘(iii) biosimilar biological product pro-
gram fees under subsection (a)(3). 
‘‘(B) LIMITATIONS
ON
FEE
AMOUNTS.— 
Until the first fiscal year for which the capacity 
planning adjustment under subsection (c)(2) is 
effective, the amount of any fee under sub-
section (a) for a fiscal year after fiscal year 
2018 shall not exceed 125 percent of the 
amount of such fee for fiscal year 2018. 
‘‘(C) BIOSIMILAR
BIOLOGICAL
PRODUCT 
DEVELOPMENT FEES.—The initial biosimilar bi-
ological product development fee under sub-
section (a)(1)(A) for a fiscal year shall be equal 
to the annual biosimilar biological product de-
velopment fee under subsection (a)(1)(B) for 
that fiscal year. 
‘‘(D) REACTIVATION FEE.—The reactiva-
tion fee under subsection (a)(1)(D) for a fiscal 
year shall be equal to twice the amount of the 
annual biosimilar biological product develop-
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00069
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
ment fee under subsection (a)(1)(B) for that 
fiscal year. 
‘‘(4) ANNUAL BASE REVENUE.—For purposes 
of paragraph (2), the dollar amount of the annual 
base revenue for a fiscal year shall be the dollar 
amount of the total revenue amount for the previous 
fiscal year, excluding any adjustments to such rev-
enue amount under subsection (c)(3).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 
744H of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–52) is amended— 
(1) by redesignating subsections (c) through (h) 
as subsections (d) through (i), respectively; 
(2) in subsections (a)(2)(F) and (g), by striking 
‘‘subsection (c)’’ and inserting ‘‘subsection (d)’’; 
(3) in subsection (a)(4)(A), by striking ‘‘sub-
section (b)(1)(F)’’ and inserting ‘‘subsection (c)(5)’’; 
and 
(4) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of sub-
section (b)(2)(B), the dollar amount of the in-
flation adjustment to the annual base revenue 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00070
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
for each fiscal year shall be equal to the prod-
uct of— 
‘‘(i) such annual base revenue for the 
fiscal year under subsection (b); and 
‘‘(ii) the inflation adjustment percent-
age under subparagraph (B). 
‘‘(B) INFLATION ADJUSTMENT PERCENT-
AGE.—The inflation adjustment percentage 
under this subparagraph for a fiscal year is 
equal to the sum of— 
‘‘(i) 
the 
average 
annual 
percent 
change in the cost, per full-time equivalent 
position of the Food and Drug Administra-
tion, of all personnel compensation and 
benefits paid with respect to such positions 
for the first 3 years of the preceding 4 fis-
cal years, multiplied by the proportion of 
personnel compensation and benefits costs 
to total costs of the process for the review 
of biosimilar biological product applications 
(as defined in section 744G(13)) for the 
first 3 years of the preceding 4 fiscal 
years; and 
‘‘(ii) the average annual percent 
change that occurred in the Consumer 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00071
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
Price Index for urban consumers (Wash-
ington-Baltimore, 
DC-MD-VA-WV; 
Not 
Seasonally Adjusted; All items; Annual 
Index) for the first 3 years of the pre-
ceding 4 years of available data multiplied 
by the proportion of all costs other than 
personnel compensation and benefits costs 
to total costs of the process for the review 
of biosimilar biological product applications 
(as defined in section 744G(13)) for the 
first 3 years of the preceding 4 fiscal 
years. 
‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN
GENERAL.—Beginning with the 
fiscal 
year 
described 
in 
subparagraph 
(B)(ii)(II), the Secretary shall, in addition to 
the adjustment under paragraph (1), further in-
crease the fee revenue and fees under this sec-
tion for a fiscal year to reflect changes in the 
resource capacity needs of the Secretary for the 
process for the review of biosimilar biological 
product applications. 
‘‘(B) 
CAPACITY
PLANNING
METHOD-
OLOGY.— 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00072
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
‘‘(i) 
DEVELOPMENT; 
EVALUATION 
AND REPORT.—The Secretary shall obtain, 
through a contract with an independent ac-
counting or consulting firm, a report evalu-
ating options and recommendations for a 
new methodology to accurately assess 
changes in the resource and capacity needs 
of the process for the review of biosimilar 
biological product applications. The capac-
ity planning methodological options and 
recommendations presented in such report 
shall utilize and be informed by personnel 
time reporting data as an input. The re-
port shall be published for public comment 
not later than September 30, 2020. 
‘‘(ii) ESTABLISHMENT
AND
IMPLE-
MENTATION.—After review of the report 
described in clause (i) and receipt and re-
view of public comments thereon, the Sec-
retary shall establish a capacity planning 
methodology for purposes of this para-
graph, which shall— 
‘‘(I) incorporate such approaches 
and attributes as the Secretary deter-
mines appropriate; and 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00073
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
‘‘(II) be effective beginning with 
the first fiscal year for which fees are 
set after such capacity planning meth-
odology is established. 
‘‘(C) 
LIMITATION.—Under 
no 
cir-
cumstances shall an adjustment under this 
paragraph result in fee revenue for a fiscal year 
that is less than the sum of the amounts under 
subsections (b)(2)(A) (the annual base revenue 
for the fiscal year) and (b)(2)(B) (the dollar 
amount of the inflation adjustment for the fis-
cal year). 
‘‘(D) PUBLICATION
IN
FEDERAL
REG-
ISTER.—The Secretary shall publish in the Fed-
eral Register notice under paragraph (5) the fee 
revenue and fees resulting from the adjustment 
and the methodologies under this paragraph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INTERIM APPLICATION; FEE REDUC-
TION.—Until the first fiscal year for which the 
capacity planning adjustment under paragraph 
(2) is effective, the Secretary may, in addition 
to the adjustment under paragraph (1), reduce 
the fee revenue and fees under this section for 
a fiscal year as the Secretary determines appro-
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00074
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
priate for long-term financial planning pur-
poses. 
‘‘(B) GENERAL APPLICATION AND METH-
ODOLOGY.—Beginning with the first fiscal year 
for which the capacity planning adjustment 
under paragraph (2) is effective, the Secretary 
may, in addition to the adjustments under 
paragraphs (1) and (2)— 
‘‘(i) reduce the fee revenue and fees 
under this section as the Secretary deter-
mines appropriate for long-term financial 
planning purposes; or 
‘‘(ii) increase the fee revenue and fees 
under this section if such an adjustment is 
necessary to provide for not more than 21 
weeks of operating reserves of carryover 
user fees for the process for the review of 
biosimilar biological product applications. 
‘‘(C) FEDERAL REGISTER NOTICE.—If an 
adjustment under subparagraph (A) or (B) is 
made, the rationale for the amount of the in-
crease or decrease (as applicable) in fee revenue 
and fees shall be contained in the annual Fed-
eral Register notice under paragraph (5) estab-
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00075
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
lishing fee revenue and fees for the fiscal year 
involved. 
‘‘(4) FISCAL YEAR 2018 ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2018, 
the Secretary shall adjust the fee revenue and 
fees under this section in such amount (if any) 
as needed to reflect an updated assessment of 
the workload for the process for the review of 
biosimilar biological product applications. 
‘‘(B) METHODOLOGY.—The Secretary shall 
publish under paragraph (5) a description of 
the methodology used to calculate the fiscal 
year 2018 adjustment under this paragraph in 
the Federal Register notice establishing fee rev-
enue and fees for fiscal year 2018. 
‘‘(C) LIMITATION.—No adjustment under 
this paragraph shall result in an increase in fee 
revenue and fees under this section in excess of 
$9,000,000. 
‘‘(5) ANNUAL FEE SETTING.—For fiscal year 
2018 and each subsequent fiscal year, the Secretary 
shall, not later than 60 days before the start of each 
such fiscal year— 
‘‘(A) establish, for the fiscal year, initial 
and annual biosimilar biological product devel-
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00076
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
opment fees and reactivation fees under sub-
section (a)(1), biosimilar biological product ap-
plication fees under subsection (a)(2), and bio-
similar biological product program fees under 
subsection 
(a)(3), 
based 
on 
the 
revenue 
amounts established under subsection (b) and 
the adjustments provided under this subsection; 
and 
‘‘(B) publish such fee revenue and fees in 
the Federal Register. 
‘‘(6) LIMIT.—The total amount of fees assessed 
for a fiscal year under this section may not exceed 
the total costs for such fiscal year for the resources 
allocated for the process for the review of biosimilar 
biological product applications.’’. 
(d) APPLICATION FEE WAIVER FOR SMALL BUSI-
NESS.—Subsection (d)(1) of section 744H of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as 
redesignated by subsection (c)(1), is amended— 
(1) by striking subparagraph (B); 
(2) by striking ‘‘shall pay—’’ and all that fol-
lows through ‘‘application fees’’ and inserting ‘‘shall 
pay application fees’’; and 
(3) by striking ‘‘; and’’ at the end and inserting 
a period. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00077
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(e) EFFECT OF FAILURE TO PAY FEES.—Subsection 
(e) of section 744H of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–52), as redesignated by sub-
section (c)(1), is amended by striking ‘‘all fees’’ and in-
serting ‘‘all such fees’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Sub-
section (f) of section 744H of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–52), as redesignated 
by subsection (c)(1), is amended— 
(1) in paragraph (2)— 
(A) by striking subparagraph (C) (relating 
to fee collection during first program year) and 
inserting the following: 
‘‘(C) COMPLIANCE.—The Secretary shall 
be considered to have met the requirements of 
subparagraph (B) in any fiscal year if the costs 
described in such subparagraph are not more 
than 15 percent below the level specified in 
such subparagraph.’’; and 
(B) in subparagraph (D)— 
(i) in the heading, by striking ‘‘IN 
SUBSEQUENT YEARS’’; and 
(ii) by striking ‘‘(after fiscal year 
2013)’’; and 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00078
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(2) in paragraph (3), by striking ‘‘2013 
through 2017’’ and inserting ‘‘2018 through 2022’’. 
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744I of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–53) is amended— 
(1) in subsection (a)— 
(A) by striking ‘‘2013’’ and inserting 
‘‘2018’’; and 
(B) by striking ‘‘Biosimilar User Fee Act 
of 2012’’ and inserting ‘‘Biosimilar User Fee 
Amendments of 2017’’; 
(2) in subsection (b), by striking ‘‘2013’’ and 
inserting ‘‘2018’’; 
(3) by striking subsection (d); 
(4) by redesignating subsection (e) as sub-
section (d); and 
(5) in subsection (d), as so redesignated, by 
striking ‘‘2017’’ each place it appears and inserting 
‘‘2022’’. 
SEC. 405. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744G and 744H of 
the Federal Food, Drug, and Cosmetic Act, as amended 
by section 403 of this Act, shall cease to be effective Octo-
ber 1, 2022. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00079
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(b) REPORTING REQUIREMENTS.—Section 744I of 
the Federal Food, Drug, and Cosmetic Act, as amended 
by section 404 of this Act, shall cease to be effective Janu-
ary 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN GENERAL.—Effective October 1, 2017, 
section 404 of the Food and Drug Administration 
Safety and Innovation Act (Public Law 112–144) is 
repealed. 
(2) CONFORMING AMENDMENT.—The Food and 
Drug Administration Safety and Innovation Act 
(Public Law 112–144) is amended in the table of 
contents in section 2 by striking the item relating to 
section 404. 
SEC. 406. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2017, or the date of the enactment of this 
Act, whichever is later, except that fees under part 8 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all biosimilar bio-
logical product applications received on or after October 
1, 2017, regardless of the date of the enactment of this 
Act. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00080
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
SEC. 407. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 8 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as in effect on the day before 
the date of the enactment of this title, shall continue to 
be in effect with respect to biosimilar biological product 
applications and supplements (as defined in such part as 
of such day) that were accepted by the Food and Drug 
Administration for filing on or after October 1, 2012, but 
before October 1, 2017, with respect to assessing and col-
lecting any fee required by such part for a fiscal year prior 
to fiscal year 2018. 
TITLE V—REAUTHORIZATION OF 
OTHER PROGRAMS 
SEC. 501. REAUTHORIZATION OF PROVISION RELATING TO 
EXCLUSIVITY 
OF 
CERTAIN 
DRUGS 
CON-
TAINING SINGLE ENANTIOMERS. 
Section 505(u)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by strik-
ing ‘‘2017’’ and inserting ‘‘2022’’. 
SEC. 502. REAUTHORIZATION OF PEDIATRIC HUMANI-
TARIAN DEVICE EXCEPTIONS. 
Section 520(m)(6)(A)(iv) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is 
amended by striking ‘‘2017’’ and inserting ‘‘2022’’. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00081
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
SEC. 503. REAUTHORIZATION OF THE CRITICAL PATH PUB-
LIC-PRIVATE PARTNERSHIPS. 
Section 566(f) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–5(f)) is amended by striking 
‘‘2013 through 2017’’ and inserting ‘‘2018 through 
2022’’. 
SEC. 504. REAUTHORIZATION OF PEDIATRIC DEVICE CON-
SORTIA. 
Section 305(e) of Pediatric Medical Device Safety 
and Improvement Act of 2007 (Public Law 110–85; 42 
U.S.C. 282 note) is amended by striking ‘‘2013 through 
2017’’ and inserting ‘‘2018 through 2022’’. 
SEC. 505. REAUTHORIZATION OF ORPHAN GRANTS PRO-
GRAM. 
Section 5(c) of the Orphan Drug Act (21 U.S.C. 
360ee(c)) is amended by striking ‘‘2013 through 2017’’ 
and inserting ‘‘2018 through 2022’’. 
SEC. 506. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by strik-
ing ‘‘October 1, 2017’’ and inserting ‘‘October 1, 2022’’. 
SEC. 507. REAUTHORIZATION OF PEDIATRIC STUDY OF 
DRUGS. 
Section 409I(e)(1) of the Public Health Service Act 
(42 U.S.C. 284m(e)(1)) is amended by striking ‘‘2013 
through 2017’’ and inserting ‘‘2018 through 2022’’. 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00082
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
TITLE VI—ADDITIONAL 
PROVISIONS 
SEC. 601. TECHNICAL CORRECTIONS. 
(a) Section 3075(a) of the 21st Century Cures Act 
(Public Law 114–255) is amended— 
(1) in the matter preceding paragraph (1), by 
striking ‘‘as amended by section 2074’’ and inserting 
‘‘as amended by section 3102’’; and 
(2) in paragraph (2), by striking ‘‘section 
2074(1)(C)’’ and inserting ‘‘section 3102(1)(C)’’. 
(b) Section 506G(b)(1)(A) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is 
amended by striking ‘‘identity’’ and inserting ‘‘identify’’. 
(c) Section 505F(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355g(b)) is amended by striking 
‘‘randomized’’ and inserting ‘‘traditional’’. 
(d) Section 505F(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355g(d)) is amended by striking 
‘‘2’’ and inserting ‘‘3’’. 
(e) Effective as of the enactment of the 21st Century 
Cures Act (Public Law 114–255)— 
(1) section 3051(a) of such Act is amended by 
striking ‘‘by inserting after section 515B’’ and in-
serting ‘‘by inserting after section 515A’’; and 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00083
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS
(2) section 515C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e–3), as inserted 
by such section 3051(a), is redesignated as section 
515B. 
(f) Section 515B(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e–3(f)(2)), as redesig-
nated by subsection (d)(2) of this section, is amended by 
striking ‘‘a proposed guidance’’ and inserting ‘‘a draft 
version of that guidance’’. 
(g) Section 513(b)(5)(D) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(b)(5)(D)) is amended 
by striking ‘‘medical device submissions’’ and inserting 
‘‘medical devices that may be specifically the subject of 
a review by a classification panel’’. 
Æ 
VerDate Sep 11 2014 
21:25 May 18, 2017
Jkt 069200
PO 00000
Frm 00084
Fmt 6652
Sfmt 6301
E:\BILLS\H2430.IH
H2430
sradovich on DSK3GMQ082PROD with BILLS