established under paragraph (1) for the pre-
vious fiscal year, not including any adjustments 
made under subsection (c)(3) or (c)(4).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Sub-
section (c) of section 736 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h) is amended to read as fol-
lows: 
‘‘(c) ADJUSTMENTS; ANNUAL FEE SETTING.— 
‘‘(1) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For purposes of sub-
section (b)(1)(B), the dollar amount of the in-
flation adjustment to the annual base revenue 
for each fiscal year shall be equal to the prod-
uct of— 
‘‘(i) such annual base revenue for the 
fiscal year under subsection (b)(1)(A); 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-
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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 human drug applications (as defined in 
section 735(6)) for the first 3 years of the 
preceding 4 fiscal years; and 
‘‘(ii) the average annual percent 
change that occurred in the Consumer 
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 human drug applications (as defined in 
section 735(6)) for the first 3 years of the 
preceding 4 fiscal years. 
‘‘(2) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For each fiscal year, 
after the annual base revenue established in 
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subsection (b)(1)(A) is adjusted for inflation in 
accordance with paragraph (1), such revenue 
shall be adjusted further for such fiscal year, in 
accordance with this paragraph, to reflect 
changes in the resource capacity needs of the 
Secretary for the process for the review of 
human drug applications. 
‘‘(B) INTERIM METHODOLOGY.— 
‘‘(i) IN GENERAL.—Until the capacity 
planning methodology described in sub-
paragraph (C) is effective, the adjustment 
under this paragraph for a fiscal year shall 
be based on the product of— 
‘‘(I) the annual base revenue for 
such year, as adjusted for inflation 
under paragraph (1); and 
‘‘(II) the adjustment percentage 
under clause (ii). 
‘‘(ii) ADJUSTMENT
PERCENTAGE.— 
The adjustment percentage under this 
clause for a fiscal year is the weighted 
change in the 3-year average ending in the 
most recent year for which data are avail-
able, over the 3-year average ending in the 
previous year, for— 
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‘‘(I) the total number of human 
drug applications, efficacy supple-
ments, and manufacturing supple-
ments submitted to the Secretary; 
‘‘(II) the total number of active 
commercial investigational new drug 
applications; and 
‘‘(III) the total number of formal 
meetings scheduled by the Secretary, 
and written responses issued by the 
Secretary in lieu of such formal meet-
ings, as identified in section I.H of 
the letters described in section 101(b) 
of the Prescription Drug User Fee 
Amendments of 2017. 
‘‘(C) 
CAPACITY
PLANNING
METHOD-
OLOGY.— 
‘‘(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 human 
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drug applications. The capacity planning 
methodological options and recommenda-
tions presented in such report shall utilize 
and be informed by personnel time report-
ing data as an input. The report shall be 
published for public comment no later than 
the end of fiscal year 2020. 
‘‘(ii) ESTABLISHMENT
AND
IMPLE-
MENTATION.—After review of the report 
described in clause (i) and any public com-
ments thereon, the Secretary shall estab-
lish a capacity planning methodology for 
purposes of this paragraph, which shall— 
‘‘(I) replace the interim method-
ology under subparagraph (B); 
‘‘(II) 
incorporate 
such 
ap-
proaches and attributes as the Sec-
retary determines appropriate; and 
‘‘(III) be effective beginning with 
the first fiscal year for which fees are 
set after such capacity planning meth-
odology is established. 
‘‘(D) 
LIMITATION.—Under 
no 
cir-
cumstances shall an adjustment under this 
paragraph result in fee revenue for a fiscal year 
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that is less than the sum of the amounts under 
subsections (b)(1)(A) (the annual base revenue 
for the fiscal year) and (b)(1)(B) (the dollar 
amount of the inflation adjustment for the fis-
cal year). 
‘‘(E) 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) INCREASE.—For fiscal year 2018 and 
subsequent fiscal years, the Secretary may, in 
addition to adjustments under paragraphs (1) 
and (2), further increase the fee revenue and 
fees if such an adjustment is necessary to pro-
vide for not more than 14 weeks of operating 
reserves of carryover user fees for the process 
for the review of human drug applications. 
‘‘(B) DECREASE.—If the Secretary has 
carryover balances for such process in excess of 
14 weeks of such operating reserves, the Sec-
retary shall decrease such fee revenue and fees 
to provide for not more than 14 weeks of such 
operating reserves. 
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‘‘(C) NOTICE OF RATIONALE.—If an ad-
justment 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-
lishing fee revenue and fees for the fiscal year 
involved. 
‘‘(4) 
ADDITIONAL
DIRECT
COST
ADJUST-
MENT.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
in addition to adjustments under paragraphs 
(1), (2), and (3), further increase the fee rev-
enue and fees— 
‘‘(i) 
for 
fiscal 
year 
2018, 
by 
$8,730,000; and 
‘‘(ii) for fiscal year 2019 and subse-
quent fiscal years, by the amount deter-
mined under subparagraph (B). 
‘‘(B) AMOUNT.—The amount determined 
under this subparagraph is— 
‘‘(i) $8,730,000, multiplied by 
‘‘(ii) the Consumer Price Index for 
urban consumers (Washington-Baltimore, 
DC-MD-VA-WV; Not Seasonally Adjusted; 
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All Items; Annual Index) for the most re-
cent year of available data, divided by such 
Index for 2016. 
‘‘(5) ANNUAL
FEE
SETTING.—The Secretary 
shall, not later than 60 days before the start of each 
fiscal year that begins after September 30, 2017— 
‘‘(A) establish, for the next fiscal year, 
human drug application fees and prescription 
drug program fees under subsection (a), based 
on the revenue amounts established under sub-
section (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 charged, 
as adjusted under this subsection, for a fiscal year 
may not exceed the total costs for such fiscal year 
for the resources allocated for the process for the re-
view of human drug applications.’’. 
(d) FEE WAIVER OR REDUCTION.—Section 736(d) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(d)) is amended— 
(1) in paragraph (1)— 
(A) by inserting ‘‘or’’ at the end of sub-
paragraph (B); 
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(B) by striking subparagraph (C); and 
(C) by redesignating subparagraph (D) as 
subparagraph (C); 
(2) by striking paragraph (3) (relating to use of 
standard costs); 
(3) by redesignating paragraph (4) as para-
graph (3); and 
(4) in paragraph (3), as so redesignated— 
(A) in subparagraphs (A) and (B), by 
striking ‘‘paragraph (1)(D)’’ and inserting 
‘‘paragraph (1)(C)’’; and 
(B) in subparagraph (B)— 
(i) by striking clause (ii); 
(ii) by striking ‘‘shall pay’’ through 
‘‘(i) application fees’’ and inserting ‘‘shall 
pay application fees’’; and 
(iii) by striking ‘‘; and’’ at the end 
and inserting a period. 
(e) EFFECT OF FAILURE TO PAY FEES.—Section 
736(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h(e)) is amended by striking ‘‘all fees’’ and in-
serting ‘‘all such fees’’. 
(f) LIMITATIONS.—Section 736(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is 
amended by striking ‘‘supplements, prescription drug es-
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tablishments, and prescription drug products’’ and insert-
ing ‘‘prescription drug program fees’’. 
(g) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 736(g) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379h(g)) is amended— 
(1) in paragraph (3)— 
(A) by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’; and 
(B) by striking ‘‘and paragraph (4) of this 
subsection’’; and 
(2) by striking paragraph (4). 
(h) ORPHAN DRUGS.—Section 736(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is 
amended by striking ‘‘product and establishment fees’’ 
each place it appears and inserting ‘‘prescription drug pro-
gram fees’’. 
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 736B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379h–2) is amended— 
(1) in subsection (a)(1)— 
(A) in the matter before subparagraph (A), 
by striking ‘‘2013’’ and inserting ‘‘2018’’; and 
(B) in subparagraph (A), by striking ‘‘Pre-
scription Drug User Fee Amendments of 2012’’ 
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and inserting ‘‘Prescription 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. 104. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 735 and 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 
379h) shall cease to be effective October 1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 736B of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h–2) shall cease to be effective January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
ber 1, 2017, subsections (a) and (b) of section 105 of the 
Food and Drug Administration Safety and Innovation Act 
(Public Law 112–144) are repealed. 
SEC. 105. 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 2 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all human drug 
applications received on or after October 1, 2017, regard-
less of the date of the enactment of this Act. 
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SEC. 106. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 2 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 human drug applications and 
supplements (as defined in such part as of such day) that 
on or after October 1, 2012, but before October 1, 2017, 
were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2018. 
TITLE II—FEES RELATING TO 
DEVICES 
SEC. 201. SHORT TITLE; FINDINGS. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Medical Device User Fee Amendments of 2017’’. 
(b) FINDINGS.—The Congress finds that the fees au-
thorized under the amendments made by this title will be 
dedicated toward expediting the process for the review of 
device applications and for assuring the safety and effec-
tiveness of devices, as set forth in the goals identified for 
purposes of part 3 of subchapter C of chapter VII of the 
Federal 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 
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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. 202. DEFINITIONS. 
Section 737 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379i) is amended— 
(1) by redesignating paragraphs (8) through 
(13) as paragraphs (9) through (14), respectively; 
(2) by inserting after paragraph (7) the fol-
lowing new paragraph: 
‘‘(8) The term ‘de novo classification request’ 
means a request made under section 513(f)(2)(A) 
with respect to the classification of a device.’’; 
(3) in subparagraph (D) of paragraph (10) (as 
redesignated by paragraph (1)), by striking ‘‘and 
submissions’’ and inserting ‘‘submissions, and de 
novo classification requests’’; and 
(4) in paragraph (11) (as redesignated by para-
graph (1)), by striking ‘‘2011’’ and inserting 
‘‘2016’’. 
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES. 
(a) TYPES OF FEES.—Section 738(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is 
amended— 
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(1) in paragraph (1), by striking ‘‘fiscal year 
2013’’ and inserting ‘‘fiscal year 2018’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘October 1, 2012’’ and insert-
ing ‘‘October 1, 2017’’; 
(ii) in clause (viii), by striking ‘‘2’’ 
and inserting ‘‘3.4’’; and 
(iii) by adding at the end the fol-
lowing new clause: 
‘‘(xi) For a de novo classification re-
quest, a fee equal to 30 percent of the fee 
that applies under clause (i).’’; and 
(B) in subparagraph (B)(v)(I), by striking 
‘‘or premarket notification submission’’ and in-
serting ‘‘premarket notification submission, or 
de novo classification request’’. 
(b) FEE AMOUNTS.—Section 738(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is 
amended to read as follows: 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsections (c), 
(d), (e), and (h), for each of fiscal years 2018 
through 2022, fees under subsection (a) shall be de-
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rived from the base fee amounts specified in para-
graph (2), to generate the total revenue amounts 
specified in paragraph (3). 
‘‘(2) BASE
FEE
AMOUNTS
SPECIFIED.—For 
purposes of paragraph (1), the base fee amounts 
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 
‘‘(3) TOTAL REVENUE AMOUNTS SPECIFIED.— 
For purposes of paragraph (1), the total revenue 
amounts specified in this paragraph are as follows: 
‘‘(A) $183,280,756 for fiscal year 2018. 
‘‘(B) $190,654,875 for fiscal year 2019. 
‘‘(C) $200,132,014 for fiscal year 2020. 
‘‘(D) $211,748,789 for fiscal year 2021. 
‘‘(E) $213,687,660 for fiscal year 2022.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—Section 
738(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j(c)) is amended— 
(1) in paragraph (1), by striking ‘‘2012’’ and 
inserting ‘‘2017’’; 
(2) in paragraph (2)— 
(A) in subparagraph (A), by striking 
‘‘2014’’ and inserting ‘‘2018’’; 
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(B) by striking subparagraph (B) and in-
serting the following new subparagraph: 
‘‘(B) APPLICABLE
INFLATION
ADJUST-
MENT.—The applicable inflation adjustment for 
fiscal year 2018 and each subsequent fiscal 
year is the product of— 
‘‘(i) the base inflation adjustment 
under subparagraph (C) for such fiscal 
year; and 
‘‘(ii) the product of the base inflation 
adjustment under subparagraph (C) for 
each of the fiscal years preceding such fis-
cal year, beginning with fiscal year 2016.’’; 
(C) in subparagraph (C), in the heading, 
by striking ‘‘TO TOTAL REVENUE AMOUNTS’’; 
and 
(D) by amending subparagraph (D) to 
read as follows: 
‘‘(D) 
ADJUSTMENT
TO
BASE
FEE 
AMOUNTS.—For each of fiscal years 2018 
through 2022, the Secretary shall— 
‘‘(i) adjust the base fee amounts spec-
ified in subsection (b)(2) for such fiscal 
year by multiplying such amounts by the 
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applicable inflation adjustment under sub-
paragraph (B) for such year; and 
‘‘(ii) if the Secretary determines nec-
essary, increase (in addition to the adjust-
ment under clause (i)) such base fee 
amounts, on a uniform proportionate basis, 
to generate the total revenue amounts 
under subsection (b)(3), as adjusted for in-
flation under subparagraph (A).’’; and 
(3) in paragraph (3)— 
(A) by striking ‘‘2014 through 2017’’ and 
inserting ‘‘2018 through 2022’’; and 
(B) by striking ‘‘further adjusted’’ and in-
serting ‘‘increased’’. 
(d) SMALL BUSINESSES; FEE WAIVER AND FEE RE-
DUCTION REGARDING PREMARKET APPROVAL FEES.— 
Section 738(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j(d)) is amended— 
(1) in paragraph (1), by striking ‘‘specified in 
clauses (i) through (v) and clauses (vii), (ix), and 
(x)’’ and inserting ‘‘specified in clauses (i) through 
(vii) and clauses (ix), (x), and (xi)’’; and 
(2) in paragraph (2)(C)— 
(A) by striking ‘‘supplement, or’’ and in-
serting ‘‘supplement,’’; and 
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(B) by inserting ‘‘, or a de novo classifica-
tion request’’ after ‘‘class III device’’. 
(e) SMALL BUSINESSES; FEE REDUCTION REGARD-
ING PREMARKET NOTIFICATION SUBMISSIONS.—Section 
738(e)(2)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking 
‘‘50’’ and inserting ‘‘25’’. 
(f) FEE WAIVER OR REDUCTION.— 
(1) REPEAL.—Section 738 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j) is amend-
ed by striking subsection (f). 
(2) CONFORMING CHANGES.— 
(A) Section 515(c)(4)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
360e(c)(4)(A)) is amended by striking ‘‘738(h)’’ 
and inserting ‘‘738(g)’’. 
(B) Section 738 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j), as 
amended by paragraph (1), is further amend-
ed— 
(i) by redesignating subsections (g) 
through (l) as subsections (f) through (k); 
(ii) in subsection (a)(2)(A), by strik-
ing ‘‘(d), (e), and (f)’’ and inserting ‘‘(d) 
and (e)’’; and 
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(iii) in subsection (a)(3)(A), by strik-
ing ‘‘and subsection (f)’’. 
(g) EFFECT OF FAILURE TO PAY FEES.—Subsection 
(f)(1), as redesignated, of section 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend-
ed— 
(1) by striking ‘‘or periodic reporting con-
cerning a class III device’’ and inserting ‘‘periodic 
reporting concerning a class III device, or de novo 
classification request’’; and 
(2) by striking ‘‘all fees’’ and inserting ‘‘all 
such fees’’. 
(h) CONDITIONS.—Subsection (g)(1)(A), as redesig-
nated, of section 738 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j) is amended by striking 
‘‘$280,587,000’’ and inserting ‘‘$320,825,000’’. 
(i) CREDITING AND AVAILABILITY OF FEES.—Sub-
section (h), as redesignated, of section 738 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend-
ed— 
(1) in paragraph (3)— 
(A) by striking ‘‘2013 through 2017’’ and 
inserting ‘‘2018 through 2022’’; and 
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(B) by striking ‘‘subsection (c)’’ and all 
that follows through the period at the end and 
inserting ‘‘subsection (c).’’; and 
(2) by striking paragraph (4). 
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS. 
(a) PERFORMANCE REPORTS.—Section 738A(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–1(a)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘2013’’ and inserting 
‘‘2018’’; and 
(ii) by striking ‘‘the Medical Device 
User Fee Amendments of 2012’’ and in-
serting ‘‘Medical Device User Fee Amend-
ments of 2017’’; and 
(B) in subparagraph (B), by striking ‘‘the 
Medical Device User Fee Amendments of 
2012’’ and inserting ‘‘Medical Device User Fee 
Amendments of 2017’’; and 
(2) in paragraph (2), by striking ‘‘2013 
through 2017’’ and inserting ‘‘2018 through 2022’’. 
(b) REAUTHORIZATION.—Section 738A(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
1(b)) is amended— 
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(1) in paragraph (1), by striking ‘‘2017’’ and 
inserting ‘‘2022’’; and 
(2) in paragraph (5), by striking ‘‘2017’’ and 
inserting ‘‘2022’’. 
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM. 
(a) IN GENERAL.—Section 514 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360d) is amended by 
adding at the end the following: 
‘‘(d) PILOT ACCREDITATION SCHEME
FOR CON-
FORMITY ASSESSMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a pilot program under which— 
‘‘(A) testing laboratories may be accred-
ited, by accreditation bodies meeting criteria 
specified by the Secretary, to assess the con-
formance of a device with certain standards rec-
ognized under this section; and 
‘‘(B) subject to paragraph (2), determina-
tions by testing laboratories so accredited that 
a device conforms with such standard or stand-
ards shall be accepted by the Secretary for pur-
poses of demonstrating such conformity under 
this section unless the Secretary finds that a 
particular such determination shall not be so 
accepted. 
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‘‘(2) SECRETARIAL
REVIEW
OF
ACCREDITED 
LABORATORY
DETERMINATIONS.—The 
Secretary 
may— 
‘‘(A) review determinations by testing lab-
oratories accredited pursuant to this subsection, 
including by conducting periodic audits of such 
determinations or processes of accredited bodies 
or testing laboratories and, following such re-
view, taking additional measures under this 
Act, such as suspension or withdrawal of ac-
creditation of such testing laboratory under 
paragraph (1)(A) or requesting additional infor-
mation with respect to such device, as the Sec-
retary determines appropriate; and 
‘‘(B) if the Secretary becomes aware of in-
formation materially bearing on safety or effec-
tiveness of a device assessed for conformity by 
a testing laboratory so accredited, take such ad-
ditional measures under this Act as the Sec-
retary determines appropriate, such as suspen-
sion or withdrawal of accreditation of such test-
ing laboratory under paragraph (1)(A), or re-
questing additional information with regard to 
such device. 
‘‘(3) IMPLEMENTATION AND REPORTING.— 
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‘‘(A) PUBLIC
MEETING.—The Secretary 
shall publish in the Federal Register a notice of 
a public meeting to be held no later than Sep-
tember 30, 2018, to discuss and obtain input 
and recommendations from stakeholders regard-
ing the goals and scope of, and a suitable 
framework and procedures and requirements 
for, the pilot program under this subsection. 
‘‘(B) PILOT
PROGRAM
GUIDANCE.—The 
Secretary shall— 
‘‘(i) not later than September 30, 
2019, issue draft guidance regarding the 
goals and implementation of the pilot pro-
gram under this subsection; and 
‘‘(ii) not later than September 30, 
2021, issue final guidance with respect to 
the implementation of such program. 
‘‘(C) PILOT
PROGRAM
INITIATION.—Not 
later than September 30, 2020, the Secretary 
shall initiate the pilot program under this sub-
section. 
‘‘(D) REPORT.—The Secretary shall make 
available on the website of the Food and Drug 
Administration an annual report on the 
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progress of the pilot program under this sub-
section. 
‘‘(4) SUNSET.—As of October 1, 2022— 
‘‘(A) the authority for accreditation bodies 
to accredit testing laboratories pursuant to 
paragraph (1)(A) shall cease to have force or 
effect; 
‘‘(B) the Secretary— 
‘‘(i) may not accept a determination 
pursuant to paragraph (1)(B) made by a 
testing laboratory after such date; and 
‘‘(ii) may accept such a determination 
made prior to such date; 
‘‘(C) except for purposes of accepting a de-
termination described in subparagraph (B)(ii), 
the Secretary shall not continue to recognize 
the accreditation of testing laboratories accred-
ited under paragraph (1)(A); and 
‘‘(D) the Secretary may take actions in ac-
cordance with paragraph (2) with respect to the 
determinations made prior to such date and 
recognition of the accreditation of testing lab-
oratories pursuant to determinations made 
prior to such date.’’. 
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SEC. 206. REAUTHORIZATION OF REVIEW. 
Section 523 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360m) is amended— 
(1) in subsection (a)(3)— 
(A) in subparagraph (A), by striking 
clauses (ii) and (iii) and inserting the following: 
‘‘(ii) a device classified under section 
513(f)(2) or designated under section 
515C(d); or 
‘‘(iii) a device that is of a type, or 
subset of a type, listed as not eligible for 
review under subparagraph (B)(iii).’’; 
(B) by striking subparagraph (B) and in-
serting the following: 
‘‘(B) DESIGNATION
FOR
REVIEW.—The 
Secretary shall— 
‘‘(i) issue draft guidance on the fac-
tors the Secretary will use in determining 
whether a class I or class II device type, or 
subset of such device types, is eligible for 
review by an accredited person, includ-
ing— 
‘‘(I) the risk of the device type, 
or subset of such device type; and 
‘‘(II) whether the device type, or 
subset of such device type, is perma-
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nently implantable, life sustaining, or 
life supporting; 
‘‘(ii) not later than 24 months after 
the date on which the Secretary issues 
such draft guidance, finalize such guid-
ance; and 
‘‘(iii) beginning on the date such guid-
ance is finalized, designate and post on the 
Internet website of the Food and Drug Ad-
ministration, an updated list of class I and 
class II device types, or subsets of such de-
vice types, and the Secretary’s determina-
tion with respect to whether each such de-
vice type, or subset of a device type, is eli-
gible or not eligible for review by an ac-
credited person under this section based on 
the factors described in clause (i).’’; and 
(C) by adding at the end the following: 
‘‘(C) INTERIM RULE.—Until the date on 
which the updated list is designated and posted 
in accordance with subparagraph (B)(iii), the 
list in effect on the date of enactment the Med-
ical Device User Fee Amendments of 2017 shall 
be in effect.’’; 
(2) in subsection (b)— 
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(A) in paragraph (2)— 
(i) by striking subparagraph (D); and 
(ii) by redesignating subparagraph 
(E) as subparagraph (D); and 
(B) in paragraph (3)— 
(i) by redesignating subparagraph (E) 
as subparagraph (F); 
(ii) in subparagraph (F) (as so redes-
ignated), by striking ‘‘The operations of’’ 
and all that follows through ‘‘it will—’’ 
and inserting ‘‘Such person shall agree, at 
a minimum, to include in its request for 
accreditation a commitment to, at the time 
of accreditation, and at any time it is per-
forming any review pursuant to this sec-
tion—’’; and 
(iii) by inserting after subparagraph 
(D) the following new subparagraph: 
‘‘(E) The operations of such person shall 
be in accordance with generally accepted profes-
sional and ethical business practices.’’; and 
(3) in subsection (c), by striking ‘‘2017’’ and 
inserting ‘‘2022’’. 
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SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS. 
Section 745A(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379k–1(b)) is amended by adding 
at the end the following new paragraph: 
‘‘(3) PRESUBMISSIONS AND SUBMISSIONS SOLE-
LY IN ELECTRONIC FORMAT.— 
‘‘(A) IN
GENERAL.—Beginning on such 
date as the Secretary specifies in final guidance 
issued under subparagraph (C), presubmissions 
and submissions for devices described in para-
graph (1) (and any appeals of action taken by 
the 
Secretary 
with 
respect 
to 
such 
presubmissions or submissions) shall be sub-
mitted solely in such electronic format as speci-
fied by the Secretary in such guidance. 
‘‘(B) DRAFT
GUIDANCE.—The Secretary 
shall, not later than October 1, 2019, issue 
draft guidance providing for— 
‘‘(i) any further standards for the 
submission by electronic format required 
under subparagraph (A); 
‘‘(ii) a timetable for the establishment 
by the Secretary of such further standards; 
and 
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‘‘(iii) criteria for waivers of and ex-
emptions from the requirements of this 
subsection. 
‘‘(C) FINAL
GUIDANCE.—The Secretary 
shall, not later than 12 months after the close 
of the public comment period on the draft guid-
ance issued under subparagraph (B), issue final 
guidance described in clauses (i) through (iii) of 
such subparagraph.’’. 
SEC. 208. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 3 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in 
effect on the day before the date of the enactment of this 
title, shall continue to be in effect with respect to the sub-
missions listed in section 738(a)(2)(A) of such Act (as de-
fined in such part as of such day) that on or after October 
1, 2012, but before October 1, 2017, were accepted by 
the Food and Drug Administration for filing with respect 
to assessing and collecting any fee required by such part 
for a fiscal year prior to fiscal year 2018. 
SEC. 209. 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 3 of 
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subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act shall be assessed for all submissions list-
ed in section 738(a)(2)(A) of such Act received on or after 
October 1, 2017, regardless of the date of the enactment 
of this Act. 
SEC. 210. SUNSET CLAUSE. 
(a) AUTHORIZATION.—Sections 737 and 738 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 
739j) shall cease to be effective October 1, 2022. 
(b) REPORTING REQUIREMENTS.—Section 738A (21 
U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic 
Act (regarding reauthorization and reporting require-
ments) shall cease to be effective January 31, 2023. 
(c) PREVIOUS SUNSET PROVISION.— 
(1) IN GENERAL.—Effective October 1, 2017, 
section 207(a) of the Medical Device User Fee 
Amendments of 2012 (Public Law 112–144) is re-
pealed. 
(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 207. 
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TITLE III—FEES RELATING TO 
GENERIC DRUGS 
SEC. 301. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Generic Drug User Fee Amendments of 2017’’. 
(b) FINDING.—The Congress finds that the fees au-
thorized by the amendments made in this title will be dedi-
cated to human generic drug activities, as set forth in the 
goals identified for purposes of part 7 of subchapter C 
of chapter VII of the Federal Food, Drug, and Cosmetic 
Act, in the letters from the Secretary of Health and 
Human Services to the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Chairman of the Committee on Energy and Commerce 
of the House of Representatives, as set forth in the Con-
gressional Record. 
SEC. 302. DEFINITIONS. 
Section 744A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–41) is amended— 
(1) in paragraph (1)(B), by striking ‘‘applica-
tion for a positron emission tomography drug.’’ and 
inserting ‘‘application— 
‘‘(i) for a positron emission tomog-
raphy drug; or 
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‘‘(ii) submitted by a State or Federal 
governmental entity for a drug that is not 
distributed commercially.’’; 
(2) by redesignating paragraphs (5) through 
(12) as paragraphs (6) through (13), respectively; 
and 
(3) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) The term ‘contract manufacturing organi-
zation facility’ means a manufacturing facility of a 
finished dosage form of a drug approved pursuant to 
an abbreviated new drug application, where such 
manufacturing facility is not identified in an ap-
proved abbreviated new drug application held by the 
owner of such facility or an affiliate of such owner 
or facility.’’. 
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GE-
NERIC DRUG FEES. 
(a) TYPES OF FEES.—Section 744B(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
42(a)) is amended— 
(1) in the matter preceding paragraph (1), by 
striking ‘‘fiscal year 2013’’ and inserting ‘‘fiscal year 
2018’’; 
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(2) in paragraph (1), by adding at the end the 
following: 
‘‘(E) SUNSET.—This paragraph shall cease 
to be effective October 1, 2022.’’; 
(3) in paragraph (2)— 
(A) by amending subparagraph (C) to read 
as follows: 
‘‘(C) NOTICE.—Not later than 60 days be-
fore the start of each of fiscal years 2018 
through 2022, the Secretary shall publish in the 
Federal Register the amount of the drug mas-
ter file fee established by this paragraph for 
such fiscal year.’’; and 
(B) in subparagraph (E)— 
(i) in clause (i)— 
(I) by striking ‘‘no later than the 
date’’ and inserting ‘‘on the earlier 
of— 
‘‘(I) the date’’; 
(II) by striking the period and 
inserting ‘‘; or’’; and 
(III) by adding at the end the 
following: 
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‘‘(II) the date on which the drug 
master file holder requests the initial 
completeness assessment.’’; and 
(ii) in clause (ii), by striking ‘‘notice 
provided for in clause (i) or (ii) of subpara-
graph (C), as applicable’’ and inserting 
‘‘notice provided for in subparagraph (C)’’; 
(4) in paragraph (3)— 
(A) in the heading, by striking ‘‘AND 
PRIOR APPROVAL SUPPLEMENT’’; 
(B) in subparagraph (A), by striking ‘‘or a 
prior approval supplement to an abbreviated 
new drug application’’; 
(C) by amending subparagraphs (B) and 
(C) to read as follows: 
‘‘(B) NOTICE.—Not later than 60 days be-
fore the start of each of fiscal years 2018 
through 2022, the Secretary shall publish in the 
Federal Register the amount of the fees under 
subparagraph (A) for such fiscal year. 
‘‘(C) FEE DUE DATE.—The fees required 
by subparagraphs (A) and (F) shall be due no 
later than the date of submission of the abbre-
viated new drug application or prior approval 
supplement for which such fee applies.’’; 
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(D) in subparagraph (D)— 
(i) in the heading, by inserting ‘‘, IS 
WITHDRAWN PRIOR TO BEING RECEIVED, 
OR IS NO LONGER RECEIVED’’ after ‘‘RE-
CEIVED’’; and 
(ii) by striking ‘‘The Secretary shall’’ 
and all that follows through the period and 
inserting the following: 
‘‘(i) APPLICATIONS NOT CONSIDERED 
TO HAVE BEEN RECEIVED AND APPLICA-
TIONS WITHDRAWN PRIOR TO BEING RE-
CEIVED.—The Secretary shall refund 75 
percent of the fee paid under subparagraph 
(A) for any abbreviated new drug applica-
tion that the Secretary considers not to 
have been received within the meaning of 
section 505(j)(5)(A) for a cause other than 
failure to pay fees, or that has been with-
drawn prior to being received within the 
meaning of section 505(j)(5)(A). 
‘‘(ii) APPLICATIONS NO LONGER RE-
CEIVED.—The Secretary shall refund 100 
percent of the fee paid under subparagraph 
(A) for any abbreviated new drug applica-
tion if the Secretary initially receives the 
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neric drug submission that is pending or’’ 
and inserting ‘‘in at least one generic drug 
submission that is’’; 
(iii) in clause (ii), by striking ‘‘pro-
duces,’’ and all that follows through ‘‘such 
a’’ and inserting ‘‘is identified in at least 
one generic drug submission in which the 
facility is approved to produce one or more 
active pharmaceutical ingredients or in a 
Type II active pharmaceutical ingredient 
drug master file referenced in at least one 
such’’; and 
(iv) in clause (iii), by striking ‘‘to fees 
under both such clauses’’ and inserting 
‘‘only to the fee attributable to the manu-
facture of the finished dosage forms’’; and 
(B) by amending subparagraphs (C) and 
(D) to read as follows: 
‘‘(C) NOTICE.—Within the timeframe spec-
ified in subsection (d)(1), the Secretary shall 
publish in the Federal Register the amount of 
the fees under subparagraph (A) for such fiscal 
year. 
‘‘(D) FEE DUE DATE.—For each of fiscal 
years 2018 through 2022, the fees under sub-
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paragraph (A) for such 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-
viding for the collection and obligation of 
fees for such year under this section for 
such year.’’; 
(6) by redesignating paragraph (5) as para-
graph (6); and 
(7) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) GENERIC
DRUG
APPLICANT
PROGRAM 
FEE.— 
‘‘(A) IN GENERAL.—A generic drug appli-
cant program fee shall be assessed annually as 
described in subsection (b)(2)(E). 
‘‘(B) AMOUNT.—The amount of fees estab-
lished under subparagraph (A) shall be estab-
lished under subsection (d). 
‘‘(C) NOTICE.—Within the timeframe spec-
ified in subsection (d)(1), the Secretary shall 
publish in the Federal Register the amount of 
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the fees under subparagraph (A) for such fiscal 
year. 
‘‘(D) FEE DUE DATE.—For each of fiscal 
years 2018 through 2022, the fees under sub-
paragraph (A) for such fiscal year shall be due 
on the later of— 
‘‘(i) the first business day on or after 
October 1 of each such fiscal year; or 
‘‘(ii) the first business day after the 
date of enactment of an appropriations Act 
providing for the collection and obligation 
of fees for such fiscal year under this sec-
tion for such fiscal year.’’. 
(b) FEE REVENUE AMOUNTS.—Section 744B(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–42(b)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) in the heading, by striking ‘‘2013’’ 
and inserting ‘‘2018’’; 
(ii) by striking ‘‘2013’’ and inserting 
‘‘2018’’; 
(iii) by striking ‘‘$299,000,000’’ and 
inserting ‘‘$493,600,000’’; and 
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(iv) by striking ‘‘Of that amount’’ and 
all that follows through the end of clause 
(ii); and 
(B) in subparagraph (B)— 
(i) in the heading, by striking ‘‘2014 
THROUGH
2017’’ 
and 
inserting 
‘‘2019 
THROUGH 2022’’; 
(ii) by striking ‘‘2014 through 2017’’ 
and inserting ‘‘2019 through 2022’’; 
(iii) by striking ‘‘paragraphs (2) 
through (4)’’ and inserting ‘‘paragraphs 
(2) through (5)’’; and 
(iv) by striking ‘‘$299,000,000’’ and 
inserting ‘‘$493,600,000’’; and 
(2) in paragraph (2)— 
(A) in the matter preceding subparagraph 
(A)— 
(i) by striking ‘‘paragraph (1)(A)(ii) 
for fiscal year 2013 and paragraph (1)(B) 
for each of fiscal years 2014 through 
2017’’ and inserting ‘‘such paragraph for a 
fiscal year’’; and 
(ii) by striking ‘‘through (4)’’ and in-
serting ‘‘through (5)’’; 
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(B) in subparagraph (A), by striking ‘‘Six 
percent’’ and inserting ‘‘Five percent’’; 
(C) by amending subparagraphs (B) and 
(C) to read as follows: 
‘‘(B) Thirty-three percent shall be derived 
from fees under subsection (a)(3) (relating to 
abbreviated new drug applications). 
‘‘(C) Twenty percent shall be derived from 
fees under subsection (a)(4)(A)(i) (relating to 
generic drug facilities). The amount of the fee 
for a contract manufacturing organization facil-
ity shall be equal to one-third the amount of the 
fee for a facility that is not a contract manufac-
turing organization facility. The amount of the 
fee for a facility located outside the United 
States and its territories and possessions shall 
be $15,000 higher than the amount of the fee 
for a facility located in the United States and 
its territories and possessions.’’; 
(D) in subparagraph (D)— 
(i) by striking ‘‘Fourteen percent’’ 
and inserting ‘‘Seven percent’’; 
(ii) by striking ‘‘not less than $15,000 
and not more than $30,000’’ and inserting 
‘‘$15,000’’; and 
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(iii) by striking ‘‘, as determined’’ and 
all that follows through the period at the 
end and inserting a period; and 
(E) by adding at the end the following: 
‘‘(E)(i) Thirty-five percent shall be derived 
from fees under subsection (a)(5) (relating to 
generic drug applicant program fees). For pur-
poses of this subparagraph, if a person has af-
filiates, a single program fee shall be assessed 
with respect to that person, including its affili-
ates, and may be paid by that person or any 
one of its affiliates. The Secretary shall deter-
mine the fees as follows: 
‘‘(I) If a person (including its affili-
ates) owns at least one but not more than 
5 approved abbreviated new drug applica-
tions on the due date for the fee under this 
subsection, the person (including its affili-
ates) shall be assessed a small business ge-
neric drug applicant program fee equal to 
one-tenth of the large size operation ge-
neric drug applicant program fee. 
‘‘(II) If a person (including its affili-
ates) owns at least 6 but not more than 19 
approved abbreviated new drug applica-
VerDate Sep 11 2014 
21:25 May 18, 2017
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H2430
sradovich on DSK3GMQ082PROD with BILLS